id|nct_id|ctgov_group_code|result_type|title|description
11342849|NCT03717064|BG000|Baseline|Pitavastatin/RO7049389|"Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days.~Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4."
11342850|NCT03717064|FG000|Participant Flow|Pitavastatin/RO7049389|"Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days.~Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4."
11342851|NCT03717064|OG000|Outcome|Pitavastatin/RO7049389|"Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days.~Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4."
11342852|NCT03717064|EG000|Reported Event|Pitavastatin/RO7049389|"Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days.~Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4."
11342853|NCT03717506|BG000|Baseline|Test Product|"GDC 268 Lotion applied topically as directed.~GDC 268 Lotion: GDC 268 is a topical lotion"
11342854|NCT03717506|BG001|Baseline|Reference Product|"Clindamycin Phosphate Lotion, 1% applied topically as directed.~Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product"
11342855|NCT03717506|BG002|Baseline|Placebo|"GDC Vehicle lotion applied topically as directed.~GDC Vehicle Lotion: GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs"
10851746|NCT00307931|BG000|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
11098296|NCT01575275|BG000|Baseline|Diagnostic (Aminolevulinic Acid)|"Patients receive aminolevulinic acid PO 2-4 hours before surgery.~aminolevulinic acid: Given PO~therapeutic conventional surgery: Undergo surgery"
10975354|NCT00935012|BG000|Baseline|Tafamidis 20 mg|Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
11098297|NCT01575275|FG000|Participant Flow|Diagnostic (Aminolevulinic Acid)|"Patients receive aminolevulinic acid PO 2-4 hours before surgery.~aminolevulinic acid: Given PO~therapeutic conventional surgery: Undergo surgery"
11342856|NCT03717506|BG003|Baseline|Total|Total of all reporting groups
11342857|NCT03717506|FG000|Participant Flow|Test Product|"GDC 268 Lotion applied topically as directed.~GDC 268 Lotion: GDC 268 is a topical lotion"
11342858|NCT03717506|FG001|Participant Flow|Reference Product|"Clindamycin Phosphate Lotion, 1% applied topically as directed.~Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product"
11342859|NCT03717506|FG002|Participant Flow|Placebo|"GDC Vehicle lotion applied topically as directed.~GDC Vehicle Lotion: GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs"
11342860|NCT03717506|OG000|Outcome|Test Product|"GDC 268 Lotion applied topically as directed.~GDC 268 Lotion: GDC 268 is a topical lotion"
11342861|NCT03717506|OG001|Outcome|Reference Product|"Clindamycin Phosphate Lotion, 1% applied topically as directed.~Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product"
11342862|NCT03717506|OG002|Outcome|Placebo|"GDC Vehicle lotion applied topically as directed.~GDC Vehicle Lotion: GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs"
11342863|NCT03717506|EG000|Reported Event|Test Product|"GDC 268 Lotion applied topically as directed.~GDC 268 Lotion: GDC 268 is a topical lotion"
11342864|NCT03717506|EG001|Reported Event|Reference Product|"Clindamycin Phosphate Lotion, 1% applied topically as directed.~Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug"
11342865|NCT03717506|EG002|Reported Event|Placebo|"GDC Vehicle lotion applied topically as directed.~GDC Vehicle Lotion: GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs"
11342866|NCT03718871|BG000|Baseline|Healer Control Arm|Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.
11342867|NCT03718871|BG001|Baseline|Healer HIV Testing Intervention|HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
11342868|NCT03718871|BG002|Baseline|Total|Total of all reporting groups
11342869|NCT03718871|FG000|Participant Flow|Healer Control Arm|Patients will undergo protocolized usual care at 8 healer practices, which includes HIV education and a referral to receive voluntary HIV testing at local medical clinics.
11342870|NCT03718871|FG001|Participant Flow|Healer HIV Testing Intervention|9 healers will deliver pre-test counseling and offer HIV 1/2 antigen-antibody POC test (Oraquick©) to eligible participants. Post-test counseling will be delivered and those testing positive will be provided information about where to receive linkage to HIV care.
11342871|NCT03718871|OG000|Outcome|Healer Control Arm|Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.
11342872|NCT03718871|OG001|Outcome|Healer HIV Testing Intervention|HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
11342873|NCT03718871|OG001|Outcome|Healer HIV Testing Intervention|HIV testing at 9 traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
11342874|NCT03718871|EG000|Reported Event|Healer Control Arm|Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.
11342875|NCT03718871|EG001|Reported Event|Healer HIV Testing Intervention|HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
11342876|NCT03719300|BG000|Baseline|Single Arm BC-819|The administration of BC-819 was separated into 2 phases, the induction phase, and the maintenance phase. During the induction phase, patients were to receive an intravesical instillation of BC-819 at a dose of 20 mg/50 mL aqueous solution once per week for 10 weeks according to the induction phase treatment schedule. Upon completion of the induction phase, patients transitioned to maintenance therapy of BC-819 every 3 weeks beginning at Week 12 (Visit 11) and continuing for the next 84 additional weeks until the end of the study, defined as completion of the 96-week visit (Visit 39).
11220544|NCT02334813|BG000|Baseline|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
11220545|NCT02334813|BG001|Baseline|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
11342877|NCT03719300|FG000|Participant Flow|Single Arm BC-819|The administration of BC-819 was separated into 2 phases, the induction phase, and the maintenance phase. During the induction phase, patients were to receive an intravesical instillation of BC-819 at a dose of 20 mg/50 mL aqueous solution once per week for 10 weeks according to the induction phase treatment schedule. Upon completion of the induction phase, patients transitioned to maintenance therapy of BC-819 every 3 weeks beginning at Week 12 (Visit 11) and continuing for the next 84 additional weeks until the end of the study, defined as completion of the 96-week visit (Visit 39).
11342878|NCT03719300|OG000|Outcome|Single Arm BC-819|The administration of BC-819 was separated into 2 phases, the induction phase, and the maintenance phase. During the induction phase, patients were to receive an intravesical instillation of BC-819 at a dose of 20 mg/50 mL aqueous solution once per week for 10 weeks according to the induction phase treatment schedule. Upon completion of the induction phase, patients transitioned to maintenance therapy of BC-819 every 3 weeks beginning at Week 12 (Visit 11) and continuing for the next 84 additional weeks until the end of the study, defined as completion of the 96-week visit (Visit 39).
11342879|NCT03719300|EG000|Reported Event|Single Arm BC-819|The administration of BC-819 was separated into 2 phases, the induction phase, and the maintenance phase. During the induction phase, patients were to receive an intravesical instillation of BC-819 at a dose of 20 mg/50 mL aqueous solution once per week for 10 weeks according to the induction phase treatment schedule. Upon completion of the induction phase, patients transitioned to maintenance therapy of BC-819 every 3 weeks beginning at Week 12 (Visit 11) and continuing for the next 84 additional weeks until the end of the study, defined as completion of the 96-week visit (Visit 39).
10845294|NCT00266279|FG000|Participant Flow|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
10845295|NCT00266279|OG000|Outcome|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
10851747|NCT00307931|FG000|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
10851748|NCT00307931|OG000|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
11220546|NCT02334813|BG002|Baseline|Total|Total of all reporting groups
11342880|NCT03719378|BG000|Baseline|Traditional Fluid|"NPO Clears and Food after midnight.~2 Liters of lactated ringers administered by anesthesia intraoperatively.~Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters).~Normal diet postoperatively."
11342881|NCT03719378|BG001|Baseline|Oral Fluid|"Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.)~NPO Food/Milk: none beginning 8 hours prior to procedure time.~Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.)~Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total.~PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days.~Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement."
11342882|NCT03719378|BG002|Baseline|Total|Total of all reporting groups
11342883|NCT03719378|FG000|Participant Flow|Traditional Fluid|"NPO Clears and Food after midnight.~2 Liters of lactated ringers administered by anesthesia intraoperatively.~Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters).~Normal diet postoperatively."
11342884|NCT03719378|FG001|Participant Flow|Oral Fluid|"Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.)~NPO Food/Milk: none beginning 8 hours prior to procedure time.~Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.)~Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total.~PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days.~Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement."
11342885|NCT03719378|OG000|Outcome|Traditional Fluid|"NPO Clears and Food after midnight.~2 Liters of lactated ringers administered by anesthesia intraoperatively.~Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters).~Normal diet postoperatively."
11342886|NCT03719378|OG001|Outcome|Oral Fluid|"Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.)~NPO Food/Milk: none beginning 8 hours prior to procedure time.~Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.)~Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total.~PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days.~Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement."
11342887|NCT03719378|EG000|Reported Event|Traditional Fluid|"NPO Clears and Food after midnight.~2 Liters of lactated ringers administered by anesthesia intraoperatively.~Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters).~Normal diet postoperatively."
11342888|NCT03719378|EG001|Reported Event|Oral Fluid|"Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.)~NPO Food/Milk: none beginning 8 hours prior to procedure time.~Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.)~Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total.~PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days.~Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement."
11342889|NCT03719586|BG000|Baseline|Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)|Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg remdesivir 2.5 mg/kg)
11342890|NCT03719586|BG001|Baseline|Arm B: MAb114 Plus Optimized Standard of Care (oSOC)|MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
11342891|NCT03719586|BG002|Baseline|Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)|REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
11342892|NCT03719586|BG003|Baseline|Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)|ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
11342893|NCT03719586|BG004|Baseline|Total|Total of all reporting groups
11342894|NCT03719586|FG000|Participant Flow|Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)|Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg remdesivir 2.5 mg/kg)
11342895|NCT03719586|FG001|Participant Flow|Arm B: MAb114 Plus Optimized Standard of Care (oSOC)|MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
11342896|NCT03719586|FG002|Participant Flow|Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)|REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
11342897|NCT03719586|FG003|Participant Flow|Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)|ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
10975355|NCT00935012|FG000|Participant Flow|Tafamidis 20 mg|Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
11098298|NCT01575275|OG000|Outcome|Diagnostic (Aminolevulinic Acid)|"Patients receive aminolevulinic acid PO 2-4 hours before surgery.~aminolevulinic acid: Given PO~therapeutic conventional surgery: Undergo surgery"
11126993|NCT01736553|OG000|Outcome|Correlation With TIMPSI|Healthy Control Subjects Motor Test- TIMPSI correlated with the CMAP exam
11342898|NCT03719586|OG000|Outcome|Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)|Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg remdesivir 2.5 mg/kg)
11342899|NCT03719586|OG001|Outcome|Arm B: MAb114 Plus Optimized Standard of Care (oSOC)|MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
11342900|NCT03719586|OG002|Outcome|Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)|REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
11342901|NCT03719586|OG003|Outcome|Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)|ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
11342902|NCT03719586|EG000|Reported Event|Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)|Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg remdesivir 2.5 mg/kg)
11342903|NCT03719586|EG001|Reported Event|Arm B: MAb114 Plus Optimized Standard of Care (oSOC)|MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
11342904|NCT03719586|EG002|Reported Event|Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)|REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
11342905|NCT03719586|EG003|Reported Event|Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)|ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
11342906|NCT03719612|BG000|Baseline|DEFINITY®|"Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound~DEFINITY®: All subjects will receive a single dose of DEFINITY®"
11342907|NCT03719612|FG000|Participant Flow|DEFINITY®|"Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound~DEFINITY®: All subjects will receive a single dose of DEFINITY®"
11342908|NCT03719612|OG000|Outcome|Blinded Reader 1|Independent Blinded Reader 1 of 3
11342909|NCT03719612|OG001|Outcome|Blinded Reader 2|Independent Blinded Reader 2 of 3
11342910|NCT03719612|OG002|Outcome|Blinded Reader 3|Independent Blinded Reader 3 of 3
11342911|NCT03719612|EG000|Reported Event|DEFINITY®|"Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound~DEFINITY®: All subjects will receive a single dose of DEFINITY®"
11342912|NCT03719677|BG000|Baseline|Habit Development Intervention|"Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.~Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning"
11342913|NCT03719677|FG000|Participant Flow|Habit Development Intervention|"Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.~Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning"
11342914|NCT03719677|OG000|Outcome|Habit Development Intervention|"Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.~Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning"
11342915|NCT03719677|EG000|Reported Event|Habit Development Intervention|"Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.~Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning"
11342916|NCT03719885|BG000|Baseline|Study Group|The participants recruited for this study were those who had a clinical diagnosis of Sjogren's Syndrome (SS) and produced 10 mm. or less of tears over the course of 5 minutes (measured using Schirmer strips).
11342917|NCT03719885|FG000|Participant Flow|Study Group|The participants recruited for this study were those who were 22 years or older, had a clinical diagnosis of Sjogren's Syndrome (SS), and produced 10 mm. or less of tears over the course of 5 minutes (measured using Schirmer strips). They also had to have an OSDI score ≥13.
11342918|NCT03719885|OG000|Outcome|Intervention|TrueTear Intranasal Tear Neurostimulator: This study will evaluate the difference between active and control applications in tear production during active stimulation as measured by Schirmer testing
10975356|NCT00935012|OG000|Outcome|Tafamidis 20 mg|Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
10975357|NCT00935012|EG000|Reported Event|Tafamidis 20 mg|Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
10975358|NCT00935064|BG000|Baseline|Aliskiren|300 mg, once daily, for 6 weeks
10975359|NCT00935064|BG001|Baseline|Placebo|Once daily, for 6 weeks
10975360|NCT00935064|BG002|Baseline|Total|Total of all reporting groups
10975361|NCT00935064|FG000|Participant Flow|Aliskiren|300 mg, once daily, for 6 weeks
11126994|NCT01736553|OG001|Outcome|Correlation With AIMS|Healthy Control Subjects Motor Test- AIMS correlated with the CMAP exam
10975362|NCT00935064|FG001|Participant Flow|Placebo|Once daily, for 6 weeks
10975363|NCT00935064|OG000|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
10975364|NCT00935064|OG001|Outcome|Placebo|Once daily, for 6 weeks
11342919|NCT03719885|OG000|Outcome|Intervention|TrueTear Intranasal Tear Neurostimulator: This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease
11098299|NCT01575275|EG000|Reported Event|Diagnostic (Aminolevulinic Acid)|"Patients receive aminolevulinic acid PO 2-4 hours before surgery.~aminolevulinic acid: Given PO~therapeutic conventional surgery: Undergo surgery"
11098300|NCT01575522|BG000|Baseline|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11342920|NCT03719885|OG000|Outcome|Intervetion|TrueTear Intranasal Tear Neurostimulator: This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease
11342921|NCT03719885|EG000|Reported Event|Study Group|The participants recruited for this study were those who had a clinical diagnosis of Sjogren's Syndrome (SS) and produced 10 mm. or less of tears over the course of 5 minutes (measured using Schirmer strips).
11342922|NCT03720119|BG000|Baseline|Single Cohort|A single cohort of 78 patients with painful wounds >1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
11342923|NCT03720119|FG000|Participant Flow|Single Cohort|A single cohort of 78 patients with painful wounds >1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
11342924|NCT03720119|OG000|Outcome|Single Cohort|A single cohort of 78 patients with painful wounds >1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
11342925|NCT03720119|EG000|Reported Event|Single Cohort|A single cohort of 78 patients with painful wounds >1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
11342926|NCT03720470|BG000|Baseline|Placebo up to Week 16|Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
11342927|NCT03720470|BG001|Baseline|PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20|Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
11342928|NCT03720470|BG002|Baseline|PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20|Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
11342929|NCT03720470|BG003|Baseline|Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20|Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, followed by administration of oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
11342930|NCT03720470|BG004|Baseline|Total|Total of all reporting groups
11342931|NCT03720470|FG000|Participant Flow|Placebo up to Week 16|Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
11342932|NCT03720470|FG001|Participant Flow|Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20|Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 milligram (mg) tablet orally once daily post Week 16 up to Week 20.
11342933|NCT03720470|FG002|Participant Flow|Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20|Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
11342934|NCT03720470|FG003|Participant Flow|PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20|Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
11342935|NCT03720470|FG004|Participant Flow|PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20|Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
11342936|NCT03720470|FG005|Participant Flow|Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20|Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, followed by administration of oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
11342937|NCT03720470|OG000|Outcome|Placebo up to Week 16|Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
11342938|NCT03720470|OG001|Outcome|PF-04965842 100 mg + Placebo Injection up to Week 16|Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
10975365|NCT00935064|EG000|Reported Event|Aliskiren|300 mg, once daily, for 6 weeks
11126995|NCT01736553|OG000|Outcome|Correlation With TIMPSI|Healthy Control Subjects Motor Test- TIMPSI correlated with the mRNA
11342939|NCT03720470|OG002|Outcome|PF-04965842 200 mg + Placebo Injection up to Week 16|Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
11342940|NCT03720470|OG003|Outcome|Dupilumab 300 mg + Oral Placebo up to Week 16|Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
11342941|NCT03720470|OG000|Outcome|Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20|Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
11342942|NCT03720470|OG001|Outcome|Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20|Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
11342943|NCT03720470|OG002|Outcome|PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20|Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
11342944|NCT03720470|OG003|Outcome|PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20|Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
11342945|NCT03720470|OG004|Outcome|Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20|Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
11342946|NCT03720470|EG000|Reported Event|Placebo up to Week 16|Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
11342947|NCT03720470|EG001|Reported Event|PF-04965842 100 mg + Placebo Injection up to Week 16|Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
11342948|NCT03720470|EG002|Reported Event|PF-04965842 200 mg + Placebo Injection up to Week 16|Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
11342949|NCT03720470|EG003|Reported Event|Dupilumab 300 mg + Oral Placebo up to Week 16|Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
11342950|NCT03720470|EG004|Reported Event|Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20|Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
11098301|NCT01575522|FG000|Participant Flow|Treatment (Tivantinib)|"Patients receive tivantinib 360 mg PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11342951|NCT03720470|EG005|Reported Event|Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20|Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
11342952|NCT03720470|EG006|Reported Event|PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20|Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
11342953|NCT03720470|EG007|Reported Event|PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20|Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
11126996|NCT01736553|OG001|Outcome|Correlation With AIMS|Healthy Control Subjects Motor Test- AIMS correlated with the mRNA
11336355|NCT03565315|OG003|Outcome|Group 3: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11342954|NCT03720470|EG008|Reported Event|Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20|Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
11342955|NCT03720652|BG000|Baseline|8-Week Mindful Self-Compassion (MSC)|CNAs in Aim 1 participated in the standardized, 8-week Mindful Self-Compassion course. Each 8-week session lasted for 2.5 hours.
10851749|NCT00307931|EG000|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
10851750|NCT00308061|BG000|Baseline|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
11342956|NCT03720652|BG001|Baseline|6-Week Mindful Self Compassion (MSC)|CNAs from both nursing homes in Aim 2 participated in the 6-week Mindful Self-Compassion course, that was shortened and customized to fit the needs of health care staff.
11342957|NCT03720652|BG002|Baseline|Total|Total of all reporting groups
11342958|NCT03720652|FG000|Participant Flow|8-Week Mindful Self-Compassion (MSC)|"CNAs in Aim 1 will participate in the standardized, 8-week Mindful Self-Compassion course. Each 8-week session will last for 2.5 hours.~8-Week Mindful Self-Compassion (MSC): The 8-week MSC is a course of eight 2.5 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 8-session program that integrates SC and mindfulness.~It includes the following components:~Discovering Mindful Self-Compassion~Practicing Mindfulness~Practicing Lovingkindness~Discovering your Compassionate Voice~Living Deeply~Meeting Difficult Emotions~Exploring Challenging Relationships~Embracing Your Life"
11342959|NCT03720652|FG001|Participant Flow|6-Week Mindful Self Compassion (MSC)|"CNAs from both nursing homes in Aim 2 will participate in the 6-week Mindful Self-Compassion course, that was shortened and customized to fit the needs of health care staff. Each 6-week session will last for 1 hour.~6-Week Mindful Self-Compassion (MSC): The 6-week MSC is a course of six 1 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 6-session program that integrates SC and mindfulness.~It includes the following components:~What is Self-Compassion~Practicing Self-Compassion~Discovering your Compassionate Voice~Self-Compassion and Resilience~Self-Compassion and Burnout~Going Forward~This program is a shortened version of the 8-week program, specifically created for the needs of health care staff."
11342960|NCT03720652|OG000|Outcome|8-Week Mindful Self-Compassion (MSC)|CNAs in Aim 1 will participate in the standardized, 8-week Mindful Self-Compassion course. Each 8-week session will last for 2.5 hours.
11342961|NCT03720652|OG001|Outcome|6-Week Mindful Self Compassion (MSC)|CNAs from both nursing homes in Aim 2 will participate in the 6-week Mindful Self-Compassion course, that was shortened and customized to fit the needs of health care staff.
11342962|NCT03720652|OG000|Outcome|8-Week Mindful Self-Compassion (MSC)|CNAs in Aim 1 participated in the standardized, 8-week Mindful Self-Compassion course. Each 8-week session lasted for 2.5 hours.
11342963|NCT03720652|OG001|Outcome|6-Week Mindful Self Compassion (MSC)|CNAs from both nursing homes in Aim 2 participated in the 6-week Mindful Self-Compassion course, that was shortened and customized to fit the needs of health care staff.
11342964|NCT03720652|EG000|Reported Event|8-Week Mindful Self-Compassion (MSC)|"CNAs in Aim 1 will participate in the standardized, 8-week Mindful Self-Compassion course. Each 8-week session will last for 2.5 hours. Also included is a half day retreat, that CNAs may attend if they are able.~8-Week Mindful Self-Compassion (MSC): The 8-week MSC is a course of eight 2.5 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 8-session program that integrates SC and mindfulness.~It includes the following components:~Discovering Mindful Self-Compassion~Practicing Mindfulness~Practicing Lovingkindness~Discovering your Compassionate Voice~Living Deeply~Meeting Difficult Emotions~Exploring Challenging Relationships~Embracing Your Life"
11342965|NCT03720652|EG001|Reported Event|6-Week Mindful Self Compassion (MSC)|"CNAs from both nursing homes in Aim 2 will participate in the 6-week Mindful Self-Compassion course, that was shortened and customized to fit the needs of health care staff. Each 6-week session will last for 1 hour.~6-Week Mindful Self-Compassion (MSC): The 6-week MSC is a course of six 1 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 6-session program that integrates SC and mindfulness.~It includes the following components:~What is Self-Compassion~Practicing Self-Compassion~Discovering your Compassionate Voice~Self-Compassion and Resilience~Self-Compassion and Burnout~Going Forward~This program is a shortened version of the 8-week program, specifically created for the needs of health care staff."
11342966|NCT03720847|BG000|Baseline|Overall Study|All participants.
11342967|NCT03720847|FG000|Participant Flow|Active Condition, Then Inactive Condition|Beginning 7 days after ovulation, active treatment begins 7 days after ovulation with an estradiol transdermal patch (0.1 mg/24 hrs) applied to the skin weekly (spanning 14 days of treatment) along with (active) 100 mg oral micronized progesterone capsules taken twice daily by mouth for 14 days. A 1-month washout is observed. Then, beginning 7 days after ovulation, inactive placebo capsules will be taken twice daily by mouth along with the application of inactive clear patches applied to the skin weekly for 14 days.
11098302|NCT01575522|OG000|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11342968|NCT03720847|FG001|Participant Flow|Inactive Condition, Then Active Condition|Beginning 7 days after ovulation, inactive placebo capsules will be taken twice daily by mouth along with the application of inactive clear patches applied to the skin weekly for 14 days. After completing a 1-month washout, active treatment begins 7 days after ovulation with an (active) estradiol transdermal patch applied to the skin weekly (spanning 14 days of treatment) along with (active) 100 mg oral micronized progesterone capsules taken twice daily by mouth for 14 days.
11098303|NCT01575522|OG000|Outcome|Evaluation of c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
11342969|NCT03720847|OG000|Outcome|Active Estradiol + Progesterone|.1mg/day of transdermal estradiol + 100mg oral micronized progesterone twice daily (200mg/day).
11342970|NCT03720847|OG001|Outcome|Placebos|placebo patch + placebo pills twice daily.
11342971|NCT03720847|OG000|Outcome|Active Estradiol and Progesterone|.1mg/day of transdermal estradiol + 100mg oral micronized progesterone twice daily (200mg/day).
10975366|NCT00935064|EG001|Reported Event|Placebo|Once daily, for 6 weeks
11342972|NCT03720847|EG000|Reported Event|Active Estradiol + Progesterone|.1mg/day of transdermal estradiol + 100mg oral micronized progesterone twice daily (200mg/day).
11342973|NCT03720847|EG001|Reported Event|Placebos|placebo patch + placebo pills twice daily.
11342974|NCT03720938|BG000|Baseline|Control Group|Physically inactive children who did not play AVGs.
11342975|NCT03720938|BG001|Baseline|Intervention Group|"Physically inactive children who played alternately Nintendo Wii® active video games for 50-60 min, 3 days a week, 12 weeks, in laboratory environment.~Active Video Games: Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories."
11342976|NCT03720938|BG002|Baseline|Total|Total of all reporting groups
11342977|NCT03720938|FG000|Participant Flow|Control Group|Physically inactive children who did not play AVGs.
11342978|NCT03720938|FG001|Participant Flow|Intervention Group|"Physically inactive children who played alternately Nintendo Wii® active video games for 50-60 min, 3 days a week, 12 weeks, in laboratory environment.~Active Video Games: Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories."
11342979|NCT03720938|OG000|Outcome|Control Group|"Physically inactive children who did not play AVGs.~Active Video Games: Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories."
11342980|NCT03720938|OG001|Outcome|Intervention Group|"Physically inactive children who played alternately Nintendo Wii® active video games for 50-60 min, 3 days a week, 12 weeks, in laboratory environment.~Active Video Games: Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories."
11342981|NCT03720938|OG000|Outcome|Control Group|Physically inactive children who did not play AVGs.
11342982|NCT03720938|OG000|Outcome|Female|Females' enjoyment levels in AVG group playing Nintendo Wii® active video game categories of sports (boxing, tennis, golf, baseball, and bowling), balance (ski slalom, heading ball, balance bubble, ski jumping and penguin playing), aerobics (rhythm boxing,hula-hoop, cycling, step, and run), resort (jet-skiing, water skiing, table tennis, basketball, swordplay, archery, canoeing and frisbee) and training (rhythm kung fu, snowball, turning ball, Segway circuit, perfect 10, skateboard, major, obstacle course and bicycle).
11342983|NCT03720938|OG001|Outcome|Males|Males' enjoyment levels in AVG group playing Nintendo Wii® active video game categories of sports (boxing, tennis, golf, baseball, and bowling), balance (ski slalom, heading ball, balance bubble, ski jumping and penguin playing), aerobics (rhythm boxing,hula-hoop, cycling, step, and run), resort (jet-skiing, water skiing, table tennis, basketball, swordplay, archery, canoeing and frisbee) and training (rhythm kung fu, snowball, turning ball, Segway circuit, perfect 10, skateboard, major, obstacle course and bicycle).
11342984|NCT03720938|OG000|Outcome|Female|Females' enjoyment levels in AVG group playing Nintendo Wii® active video game categories of resort (jet-skiing, water skiing, table tennis, basketball, swordplay, archery, canoeing and frisbee).
11342985|NCT03720938|OG001|Outcome|Males|Males' enjoyment levels in AVG group playing Nintendo Wii® active video game categories of resort (jet-skiing, water skiing, table tennis, basketball, swordplay, archery, canoeing and frisbee).
11342986|NCT03720938|OG000|Outcome|Female|Females' enjoyment levels in AVG group playing Nintendo Wii® active video game categories of balance (ski slalom, heading ball, balance bubble, ski jumping and penguin playing).
11342987|NCT03720938|OG001|Outcome|Males|Males' enjoyment levels in AVG group playing Nintendo Wii® active video game categories of balance (ski slalom, heading ball, balance bubble, ski jumping and penguin playing).
11342988|NCT03720938|OG000|Outcome|Female|Females' enjoyment levels in AVG group playing Nintendo Wii® active video game category of aerobics (rhythm boxing,hula-hoop, cycling, step, and run).
11342989|NCT03720938|OG001|Outcome|Males|Males' enjoyment levels in AVG group playing Nintendo Wii® active video game category of aerobics (rhythm boxing,hula-hoop, cycling, step, and run).
10975367|NCT00935220|BG000|Baseline|Linagliptin 5mg|Linagliptin 5mg once daily
10975368|NCT00935220|FG000|Participant Flow|Linagliptin 5mg|Linagliptin 5mg once daily
11342990|NCT03720938|OG000|Outcome|Female|Females' enjoyment levels in AVG group playing Nintendo Wii® active video game categories of training (rhythm kung fu, snowball, turning ball, Segway circuit, perfect 10, skateboard, major, obstacle course and bicycle).
11342991|NCT03720938|OG001|Outcome|Males|Males' enjoyment levels in AVG group playing Nintendo Wii® active video game categories of training (rhythm kung fu, snowball, turning ball, Segway circuit, perfect 10, skateboard, major, obstacle course and bicycle).
11342992|NCT03720938|EG000|Reported Event|Control Group|Physically inactive children who did not play AVGs.
11342993|NCT03720938|EG001|Reported Event|Intervention Group|"Physically inactive children who played alternately Nintendo Wii® active video games for 50-60 min, 3 days a week, 12 weeks, in laboratory environment.~Active Video Games: Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories."
11342994|NCT03721172|BG000|Baseline|Placebo-controlled Phase: Placebo|Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
11342995|NCT03721172|BG001|Baseline|Placebo-controlled Phase: Apremilast 30 mg|Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
11342996|NCT03721172|BG002|Baseline|Total|Total of all reporting groups
10975369|NCT00935220|OG000|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
10975370|NCT00935220|EG000|Reported Event|Linagliptin 5mg|Linagliptin 5mg once daily
10975371|NCT00935259|BG000|Baseline|All Participants|All enrolled participants
10975372|NCT00935259|FG000|Participant Flow|Simvastatin 40 mg, Then Placebo|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
10975373|NCT00935259|FG001|Participant Flow|Placebo First, Then Simvastatin 40 mg|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
10975374|NCT00935259|OG000|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
10975375|NCT00935259|OG001|Outcome|Placebo|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
10975376|NCT00935259|OG000|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
10975377|NCT00935259|OG001|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
10975378|NCT00935259|EG000|Reported Event|Simvastatin|Simvastatin 40 mg tablets once daily for 2 weeks in either Period 1 or Period 2
11342997|NCT03721172|FG000|Participant Flow|Placebo-controlled Phase: Placebo|Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
11342998|NCT03721172|FG001|Participant Flow|Placebo-controlled Phase: Apremilast 30 mg|Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
11342999|NCT03721172|FG002|Participant Flow|Extension Phase: Apremilast 30 mg|Eligible participants who completed the placebo-controlled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
11343000|NCT03721172|OG000|Outcome|Placebo-controlled Phase: Placebo|Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
11343001|NCT03721172|OG001|Outcome|Placebo-controlled Phase: Apremilast 30 mg|Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
11343002|NCT03721172|OG002|Outcome|Apremalist: Placebo-controlled Phase and Extension Phase|All participants who received apremalist 30 mg as oral tablets BID in either the placebo-controlled phase (Week 0 to Week 16), the apremilast extension phase (Week 16 to Week 32), or both phases (Week 0 to Week 32)
11343003|NCT03721172|EG000|Reported Event|Placebo-controlled Phase: Placebo|Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
11343004|NCT03721172|EG001|Reported Event|Placebo-controlled Phase: Apremilast 30 mg|Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
11343005|NCT03721172|EG002|Reported Event|Apremalist: Placebo-controlled Phase and Extension Phase|All participants who received apremalist 30 mg as oral tablets BID in either the placebo-controlled phase (Week 0 to Week 16), the apremilast extension phase (Week 16 to Week 32), or both phases (Week 0 to Week 32).
11343006|NCT03721549|BG000|Baseline|Moderate Dose Inoculum|Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies
11343007|NCT03721549|BG001|Baseline|Higher Dose Inoculum|Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies
11343008|NCT03721549|BG002|Baseline|Total|Total of all reporting groups
11343009|NCT03721549|FG000|Participant Flow|Moderate Dose Inoculum|"Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies~Norwalk GI.1 Virus: Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu."
11343010|NCT03721549|FG001|Participant Flow|Higher Dose Inoculum|"Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies~Norwalk GI.1 Virus: Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu."
10975379|NCT00935259|EG001|Reported Event|Placebo|Placebo to simvastatin tablets once daily for 2 weeks in either Period 1 or Period 2
11343011|NCT03721549|OG000|Outcome|Moderate Dose Inoculum|Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies
11343012|NCT03721549|OG001|Outcome|Higher Dose Inoculum|Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies
11343013|NCT03721549|EG000|Reported Event|Moderate Dose Inoculum|Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies
11343014|NCT03721549|EG001|Reported Event|Higher Dose Inoculum|Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies
11343015|NCT03722030|BG000|Baseline|Strength-Training Intervention|Following baseline measures, participants will receive an initial in-person instructional session, instructional material and resistance training equipment, support and feedback via video coaching, mid-point assessment, and an in-person study visit to collect post study measures. Intervention will be 10 weeks, with 5 week follow up period.
11343016|NCT03722030|BG001|Baseline|Waitlist Control|Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
11343017|NCT03722030|BG002|Baseline|Total|Total of all reporting groups
11343018|NCT03722030|FG000|Participant Flow|Strength-Training Intervention|"Following baseline measures, participants will receive an initial in-person instructional session, instructional material and resistance training equipment, support and feedback via video coaching, mid-point assessment, and an in-person study visit to collect post study measures. Intervention will be 10 weeks, with 5 week follow up period.~Baseline Measures: Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test.~Strength-Training: 2 sessions per week (20-40 min), home-based resistance training~Mid-point Measures: Accelerometer (steps)~Post-Study Measures: Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy x-ray absorptiometry)"
11343019|NCT03722030|FG001|Participant Flow|Waitlist Control|"Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.~Baseline Measures: Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test.~Mid-point Measures: Accelerometer (steps)~Post-Study Measures: Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test."
11343020|NCT03722030|OG000|Outcome|Strength-Training Intervention|Following baseline measures, participants will receive an initial in-person instructional session, instructional material and resistance training equipment, support and feedback via video coaching, mid-point assessment, and an in-person study visit to collect post study measures. Intervention will be 10 weeks, with 5 week follow up period.
11343021|NCT03722030|OG001|Outcome|Waitlist Control|Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
11343022|NCT03722030|OG000|Outcome|Strength-Training Intervention|Following baseline measures, participants will receive an initial in-person instructional session, instructional material and resistance training equipment, support and feedback via video coaching, mid-point assessment, and an in-person study visit to collect post study measures. Intervention will be 10 weeks, with a 5 week follow up period.
11343023|NCT03722030|EG000|Reported Event|Strength-Training Intervention|Following baseline measures, participants will receive an initial in-person instructional session, instructional material and resistance training equipment, support and feedback via video coaching, mid-point assessment, and an in-person study visit to collect post study measures. Intervention will be 10 weeks, with 5 week follow up period.
11343024|NCT03722030|EG001|Reported Event|Waitlist Control|Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
11343025|NCT03722238|BG000|Baseline|Adult Compliance-Evaluable Population|The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
11343026|NCT03722238|BG001|Baseline|Adolescent Users|The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
11343027|NCT03722238|BG002|Baseline|Total|Total of all reporting groups
11343028|NCT03722238|FG000|Participant Flow|Adult Compliance-Evaluable Population|The participants included in this group were male or female of age greater than or equal to (>=) 18 years at the time of enrollment with a history of using oral over-the-counter (OTC) analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 milligram (mg) immediate release/extended release (IR/ER) tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
11343029|NCT03722238|FG001|Participant Flow|Adolescent Users|The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
11343030|NCT03722238|OG000|Outcome|Adult Compliance-Evaluable Population|The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
11343031|NCT03722238|OG001|Outcome|Adolescent Users|The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
11343032|NCT03722238|EG000|Reported Event|Adult Compliance-Evaluable Population|The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
11343033|NCT03722238|EG001|Reported Event|Adolescent Users|The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
11343034|NCT03722264|BG000|Baseline|Bilateral Treatment With OpalSeal and Transbond XT|"Experimental: OpalSeal OpalSeal will be applied~to the buccal surfaces of to-be-extracted teeth on one side of the mouth which will be determined randomly for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm.~Placebo Comparator: Transbond XT TransbondXT will be applied~to the buccal surfaces of to-be-extracted teeth on the other side of the mouth which will be determined based on which side received OpalSeal for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo."
11006982|NCT01088984|BG001|Baseline|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
11126997|NCT01736553|OG000|Outcome|Correlation With TIMPSI|Healthy Control Subjects Motor Test- TIMPSI correlated with weight
11343035|NCT03722264|FG000|Participant Flow|Bilateral Treatment With OpalSeal and Transbond XT|"Experimental: OpalSeal OpalSeal will be applied~to the buccal surfaces of to-be-extracted teeth on one side of the mouth which will be determined randomly for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm.~Placebo Comparator: Transbond XT TransbondXT will be applied~to the buccal surfaces of to-be-extracted teeth on the other side of the mouth which will be determined based on which side received OpalSeal for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo."
11343036|NCT03722264|OG000|Outcome|OpalSeal|"OpalSeal will be applied~to the buccal surfaces of to-be-extracted teeth during bonding of orthodontic brackets, or~to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm,~OpalSeal: OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets"
11343037|NCT03722264|OG001|Outcome|Transbond XT|"TransbondXT will be applied~to the buccal surfaces of to-be-extracted teeth during bonding of orthodontic brackets, or~to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo.~TransbondXT: Transbond is a primer used to bond orthodontic brackets that does not contain fluoride"
11343038|NCT03722264|EG000|Reported Event|OpalSeal|"OpalSeal will be applied~to the buccal surfaces of to-be-extracted teeth during bonding of orthodontic brackets, or~to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm,~OpalSeal: OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets"
11343039|NCT03722264|EG001|Reported Event|Transbond XT|"TransbondXT will be applied~to the buccal surfaces of to-be-extracted teeth during bonding of orthodontic brackets, or~to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo.~TransbondXT: Transbond is a primer used to bond orthodontic brackets that does not contain fluoride"
11343040|NCT03722446|BG000|Baseline|Arrow Catheter Kit.|"Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.~Arrow Catheter Kit.: The group will be randomized to receive this labor analgesia kit."
11343041|NCT03722446|BG001|Baseline|B.Braun Catheter Kit|"Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.~B.Braun Catheter Kit: The group will be randomized to receive this labor analgesia kit."
11343042|NCT03722446|BG002|Baseline|Total|Total of all reporting groups
11343043|NCT03722446|FG000|Participant Flow|Arrow Catheter Kit.|"Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.~Arrow Catheter Kit.: The group will be randomized to receive this labor analgesia kit."
11343044|NCT03722446|FG001|Participant Flow|B.Braun Catheter Kit|"Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.~B.Braun Catheter Kit: The group will be randomized to receive this labor analgesia kit."
11343045|NCT03722446|OG000|Outcome|Arrow Catheter Kit.|"Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.~Arrow Catheter Kit.: The group will be randomized to receive this labor analgesia kit."
11343046|NCT03722446|OG001|Outcome|B.Braun Catheter Kit|"Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.~B.Braun Catheter Kit: The group will be randomized to receive this labor analgesia kit."
11343047|NCT03722446|EG000|Reported Event|Arrow Catheter Kit.|"Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.~Arrow Catheter Kit.: The group will be randomized to receive this labor analgesia kit."
10845296|NCT00266279|OG000|Outcome|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine: Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
11006983|NCT01088984|BG002|Baseline|Total|Total of all reporting groups
11006984|NCT01088984|FG000|Participant Flow|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
11006985|NCT01088984|FG001|Participant Flow|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
11343048|NCT03722446|EG001|Reported Event|B.Braun Catheter Kit|"Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.~B.Braun Catheter Kit: The group will be randomized to receive this labor analgesia kit."
10851751|NCT00308061|BG001|Baseline|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
10851752|NCT00308061|BG002|Baseline|Total|Total of all reporting groups
10851753|NCT00308061|FG000|Participant Flow|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
10851754|NCT00308061|FG001|Participant Flow|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
10851755|NCT00308061|OG000|Outcome|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
10851756|NCT00308061|OG001|Outcome|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
10851757|NCT00308061|OG000|Outcome|Geometric Mean Titer|Geometric Mean Titer (GMT)
10851758|NCT00308061|EG000|Reported Event|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
10851759|NCT00308061|EG001|Reported Event|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
10851760|NCT00308074|BG000|Baseline|Aripiprazole|aripiprazole monotherapy
10851761|NCT00308074|FG000|Participant Flow|Aripiprazole|"aripiprazole monotherapy~Aripiprazole will be started at 2.5 or 5mg depending on clinical impression and severity of aggression and agitation. The dose will be evaluated weekly, according to clinical impression and adjusted if deemed appropriate, in not more than 5mg increments . The lowest effective dose will be used."
10851762|NCT00308074|OG000|Outcome|Aripiprazole|aripiprazole monotherapy
10851763|NCT00308074|EG000|Reported Event|Aripiprazole|aripiprazole monotherapy
10851764|NCT00308087|BG000|Baseline|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
10851765|NCT00308087|BG001|Baseline|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
10851766|NCT00308087|BG002|Baseline|Total|Total of all reporting groups
10851767|NCT00308087|FG000|Participant Flow|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
10851768|NCT00308087|FG001|Participant Flow|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
10851769|NCT00308087|OG000|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
10851770|NCT00308087|OG001|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
10851771|NCT00308087|EG000|Reported Event|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
10851772|NCT00308087|EG001|Reported Event|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
10851773|NCT00308139|BG000|Baseline|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
10851774|NCT00308139|BG001|Baseline|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
10851775|NCT00308139|BG002|Baseline|Total|Total of all reporting groups
10851776|NCT00308139|FG000|Participant Flow|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
10851777|NCT00308139|FG001|Participant Flow|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
10851778|NCT00308139|OG000|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
11126998|NCT01736553|OG001|Outcome|Correlation With AIMS|Healthy Control Subjects Motor Test- AIMS correlated with weight
10851779|NCT00308139|OG001|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
10851780|NCT00308139|OG000|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
10851781|NCT00308139|OG001|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
10851782|NCT00308139|OG002|Outcome|All Treatment|
10851783|NCT00308139|OG001|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
10851784|NCT00308139|OG002|Outcome|All Treatmeat|
10851785|NCT00308139|OG001|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 week).
10851786|NCT00308139|OG001|Outcome|Exenatide Twice Daily -> Exenatide Once WeeklyEdit|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
10851787|NCT00308139|OG000|Outcome|Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 0 to week 30.
10851788|NCT00308139|OG001|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) using concomitant SU at screening. Week 0 to week 30.
10851789|NCT00308139|OG002|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364
10851790|NCT00308139|OG003|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
10851791|NCT00308139|OG004|Outcome|Exenatide Once Weekly With SU|Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
10851792|NCT00308139|OG000|Outcome|Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 0 to week 30.
10851793|NCT00308139|OG001|Outcome|Exenatide Twice Daily With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) not using concomitant SU at screening. Week 0 to week 30.
10851794|NCT00308139|OG002|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364
10851795|NCT00308139|OG003|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364.
10851796|NCT00308139|OG004|Outcome|Exenatide Once Weekly With Non-SU|Subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
10851797|NCT00308139|EG000|Reported Event|Exenatide Once Weekly (WK 0-30)|Subcutaneous injection of 2 mg exenatide, once a week.
10851798|NCT00308139|EG001|Reported Event|Exenatide Twice Daily (WK 0-30)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
10975380|NCT00935272|BG000|Baseline|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
11126999|NCT01736553|OG000|Outcome|Estimated Hazard Ratio|Proportional hazards regression models used to determine if motor function scores, mRNA, and protein levels predict death in SMA subjects
10851799|NCT00308139|EG002|Reported Event|Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of 2 mg exenatide, once a week.
10851800|NCT00308139|EG003|Reported Event|Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
10851801|NCT00308139|EG004|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
10851802|NCT00308230|BG000|Baseline|Control|Structurally normal heart without heart disease
10851803|NCT00308230|BG001|Baseline|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
10851804|NCT00308230|BG002|Baseline|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
10851805|NCT00308230|BG003|Baseline|Total|Total of all reporting groups
10851806|NCT00308230|FG000|Participant Flow|Control Group|Structurally normal heart without heart disease.
10851807|NCT00308230|FG001|Participant Flow|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
10851808|NCT00308230|FG002|Participant Flow|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
10851809|NCT00308230|OG000|Outcome|Control Group|Structurally normal hearts
10975381|NCT00935272|BG001|Baseline|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
10851810|NCT00308230|OG001|Outcome|Congenital Heart Disease|TOF, DTGA, CCTGA-tetralogy of Fallot, the transposition of the great arteries, congenitally corrected transposition
10851811|NCT00308230|OG002|Outcome|Heart Failure|Left ventricular failure
10851812|NCT00308230|EG000|Reported Event|Control Group|Structurally normal heart without heart disease
10851813|NCT00308230|EG001|Reported Event|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
10851814|NCT00308230|EG002|Reported Event|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
10851815|NCT00308282|BG000|Baseline|Placebo|Placebo administered IV in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851816|NCT00308282|BG001|Baseline|30 mg LY2127399|30 milligram (mg) LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851817|NCT00308282|BG002|Baseline|60 mg LY2127399|60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851818|NCT00308282|BG003|Baseline|160 mg LY2127399|160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
11127000|NCT01736553|OG000|Outcome|Infants With Spinal Muscular Atrophy (SMN=2)|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
10851819|NCT00308282|BG004|Baseline|Total|Total of all reporting groups
10851820|NCT00308282|FG000|Participant Flow|Placebo|Placebo administered IV in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851821|NCT00308282|FG001|Participant Flow|30 mg LY2127399|30 milligram (mg) LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851822|NCT00308282|FG002|Participant Flow|60 mg LY2127399|60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851823|NCT00308282|FG003|Participant Flow|160 mg LY2127399|160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851824|NCT00308282|OG000|Outcome|Placebo|Placebo administered IV in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851825|NCT00308282|OG001|Outcome|30 mg LY2127399|30 milligram (mg) LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851826|NCT00308282|OG002|Outcome|60 mg LY2127399|60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851827|NCT00308282|OG003|Outcome|160 mg LY2127399|160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851828|NCT00308282|OG000|Outcome|30 mg LY2127399|30 milligram (mg) LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851829|NCT00308282|OG001|Outcome|60 mg LY2127399|60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851830|NCT00308282|OG002|Outcome|160 mg LY2127399|160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851831|NCT00308282|EG000|Reported Event|Placebo|Placebo administered IV in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851832|NCT00308282|EG001|Reported Event|30 mg LY2127399|30 milligram (mg) LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851833|NCT00308282|EG002|Reported Event|60 mg LY2127399|60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851834|NCT00308282|EG003|Reported Event|160 mg LY2127399|160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
10851835|NCT00308308|BG000|Baseline|TI + Insulin Glargine|TI + Insulin glargine
10851836|NCT00308308|BG001|Baseline|Insulin Aspart + Insulin Glargine|Comparator
10851837|NCT00308308|BG002|Baseline|Total|Total of all reporting groups
10851838|NCT00308308|FG000|Participant Flow|TI + Insulin Glargine|TI + Insulin glargine
10851839|NCT00308308|FG001|Participant Flow|Insulin Aspart + Insulin Glargine|Comparator
10851840|NCT00308308|OG000|Outcome|TI + Insulin Glargine|TI + Insulin glargine
10851841|NCT00308308|OG001|Outcome|Insulin Aspart + Insulin Glargine|Comparator
10851842|NCT00308308|EG000|Reported Event|TI + Insulin Glargine|TI + Insulin glargine
10851843|NCT00308308|EG001|Reported Event|Insulin Aspart + Insulin Glargine|Comparator
10851844|NCT00308555|BG000|Baseline|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain
10851845|NCT00308555|BG001|Baseline|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for chronic pain
10851846|NCT00308555|BG002|Baseline|Total|Total of all reporting groups
10851847|NCT00308555|FG000|Participant Flow|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
10851848|NCT00308555|FG001|Participant Flow|Oxycontin|Patients using oxycodone hydrochloride (OxyContin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
10851849|NCT00308555|OG000|Outcome|MS Contin|Participants on morphine treatment
10851850|NCT00308555|OG001|Outcome|Oxycodone|Participants on oxycodone treatment
10851851|NCT00308555|EG000|Reported Event|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for cancer pain
10851852|NCT00308555|EG001|Reported Event|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for cancer pain
10851853|NCT00308581|BG000|Baseline|Overall|Overall Induction
10851854|NCT00308581|FG000|Participant Flow|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
10851855|NCT00308581|FG001|Participant Flow|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
10851856|NCT00308581|FG002|Participant Flow|Overall|Overall Induction
10851857|NCT00308581|OG000|Outcome|Overall|Overall Induction
10851858|NCT00308581|OG000|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
10851859|NCT00308581|OG001|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
10975382|NCT00935272|BG002|Baseline|Total|Total of all reporting groups
11127001|NCT01736553|OG000|Outcome|Correlation With TIMPSI|Infants Diagnosed with SMN=2
10851860|NCT00308581|EG000|Reported Event|Q4W Regimen|Subjects who were randomized to and received Q4W regimen (every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
10851861|NCT00308581|EG001|Reported Event|Q2W Regimen|Subjects who were randomized to and received Q2W regimen (every 2 weeks: 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
10851862|NCT00308581|EG002|Reported Event|Induction Phase|Overall population in the Induction phase + safety follow-up period following induction phase.
10851863|NCT00308620|BG000|Baseline|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
10851864|NCT00308620|BG001|Baseline|Placebo|Placebo once daily for 8 weeks
10851865|NCT00308620|BG002|Baseline|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
10851866|NCT00308620|BG003|Baseline|Total|Total of all reporting groups
10851867|NCT00308620|FG000|Participant Flow|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
10851868|NCT00308620|FG001|Participant Flow|Placebo|Placebo once daily for 8 weeks
11098304|NCT01575522|OG000|Outcome|Evaluation of Phospho c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
10851869|NCT00308620|FG002|Participant Flow|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
10851870|NCT00308620|OG000|Outcome|Chloroquine 250mg or 500mg|Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
10851871|NCT00308620|OG001|Outcome|Placebo|Placebo orally once daily for 8 weeks
10851872|NCT00308620|OG000|Outcome|Chloroquine 250mg or 500mg|Chloroquine 500mg orally once daily x 8 weeks
10851873|NCT00308620|EG000|Reported Event|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
10851874|NCT00308620|EG001|Reported Event|Placebo|Placebo once daily for 8 weeks
10851875|NCT00308620|EG002|Reported Event|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
10851876|NCT00308711|BG000|Baseline|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
10851877|NCT00308711|BG001|Baseline|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
10851878|NCT00308711|BG002|Baseline|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
10851879|NCT00308711|BG003|Baseline|Total|Total of all reporting groups
10851880|NCT00308711|FG000|Participant Flow|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
10851881|NCT00308711|FG001|Participant Flow|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
10851882|NCT00308711|FG002|Participant Flow|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
10851883|NCT00308711|OG000|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
10851884|NCT00308711|OG001|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
10851885|NCT00308711|OG002|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
10851886|NCT00308711|EG000|Reported Event|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
10851887|NCT00308711|EG001|Reported Event|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
10851888|NCT00308711|EG002|Reported Event|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
10851889|NCT00308737|BG000|Baseline|Technosphere® Insulin|Technosphere Insulin
10851890|NCT00308737|BG001|Baseline|Usual Care|Usual care
10851891|NCT00308737|BG002|Baseline|Non-diabetes|Subjects without abnormalities in glucose control
10851892|NCT00308737|BG003|Baseline|Total|Total of all reporting groups
10851893|NCT00308737|FG000|Participant Flow|Technosphere® Insulin|Technosphere Insulin with or without basal insulin, or oral anti-diabetic medications, or any combination of the previous.
10851894|NCT00308737|FG001|Participant Flow|Usual Care|Usual care may consist of oral anti-diabetic medications, basal insulin, subcutaneous prandial insulin, or any combination of the previous.
10851895|NCT00308737|FG002|Participant Flow|Non-diabetes|Subjects without abnormalities in glucose control
10851896|NCT00308737|OG000|Outcome|Technosphere® Insulin|Technosphere Insulin
10851897|NCT00308737|OG001|Outcome|Usual Care|Usual care
10851898|NCT00308737|OG002|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
10851899|NCT00308737|EG000|Reported Event|Technosphere® Insulin|Technosphere Insulin
10851900|NCT00308737|EG001|Reported Event|Usual Care|Usual care (taking insulin)
10851901|NCT00308737|EG002|Reported Event|Non-diabetes|Subjects without abnormalities in glucose control
10851902|NCT00308750|BG000|Baseline|Enzastaurin/Pemetrexed/Carboplatin|"Enzastaurin loading dose of 1125 mg or 1200 mg orally on Day -7 (pre-chemotherapy) followed by 500 mg administered orally once daily starting from Day -6 until disease progression.~Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first."
10851903|NCT00308750|BG001|Baseline|Pemetrexed/Carboplatin|Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first.
10851904|NCT00308750|BG002|Baseline|Docetaxel/Carboplatin|Docetaxel 75 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first.
10851905|NCT00308750|BG003|Baseline|Total|Total of all reporting groups
10878793|NCT00454246|BG001|Baseline|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10851906|NCT00308750|FG000|Participant Flow|Enzastaurin/Pemetrexed/Carboplatin|"Enzastaurin loading dose of 1125 milligrams (mg) or 1200 mg orally on Day -7 (pre-chemotherapy) followed by 500 mg administered orally once daily starting from Day -6 until disease progression.~Pemetrexed 500 milligrams per square meter (mg/m^2) and carboplatin [area under the curve (AUC)] 6 milligrams*minutes per milliliter (mg*min/mL) as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first."
10851907|NCT00308750|FG001|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first.
10851908|NCT00308750|FG002|Participant Flow|Docetaxel/Carboplatin|Docetaxel 75 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first.
10851909|NCT00308750|OG000|Outcome|Enzastaurin/Pemetrexed/Carboplatin|"Enzastaurin loading dose of 1125 mg or 1200 mg orally on Day -7 (pre-chemotherapy) followed by 500 mg administered orally once daily starting from Day -6 until disease progression.~Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first."
10851910|NCT00308750|OG001|Outcome|Pemetrexed/Carboplatin|Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first.
10851911|NCT00308750|OG002|Outcome|Docetaxel/Carboplatin|Docetaxel 75 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first.
10851912|NCT00308750|OG000|Outcome|Enzastaurin/Pemetrexed/Carboplatin|"Enzastaurin loading dose of 1125 mg or 1200 mg on Day -7 (pre-chemotherapy) followed by 500 mg administered once daily starting from Day -6 until disease progression.~Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first."
10851913|NCT00308750|EG000|Reported Event|Enzastaurin/Pemetrexed/Carboplatin|"Enzastaurin loading dose of 1125 mg or 1200 mg on Day -7 (pre-chemotherapy) followed by 500 mg administered once daily starting from Day -6 until disease progression.~Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first."
10851914|NCT00308750|EG001|Reported Event|Pemetrexed/Carboplatin|Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first.
10851915|NCT00308750|EG002|Reported Event|Docetaxel/Carboplatin|Docetaxel 75 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first.
10851916|NCT00308997|BG000|Baseline|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
10851917|NCT00308997|BG001|Baseline|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
10851918|NCT00308997|BG002|Baseline|Total|Total of all reporting groups
10851919|NCT00308997|FG000|Participant Flow|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
10851920|NCT00308997|FG001|Participant Flow|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
10851921|NCT00308997|OG000|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
10851922|NCT00308997|OG001|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
10851923|NCT00308997|EG000|Reported Event|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
11098305|NCT01575522|OG000|Outcome|Evaluation of c-Met Positive Circulating Tumor Cells|
11126231|NCT02478775|FG000|Participant Flow|Experimental: Frequent Blood Sampling, Degarelix|Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.
10851924|NCT00308997|EG001|Reported Event|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
10851925|NCT00309140|BG000|Baseline|Enzastaurin|Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10851926|NCT00309140|FG000|Participant Flow|Enzastaurin|Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10851927|NCT00309140|OG000|Outcome|Enzastaurin|Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10851928|NCT00309140|EG000|Reported Event|Enzastaurin|Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10851929|NCT00309166|BG000|Baseline|Cervarix Group|Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
10851930|NCT00309166|BG001|Baseline|Engerix-B Group|Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
10851931|NCT00309166|BG002|Baseline|Total|Total of all reporting groups
10851932|NCT00309166|FG000|Participant Flow|Cervarix Group|Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
10851933|NCT00309166|FG001|Participant Flow|Engerix-B Group|Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
11127002|NCT01736553|OG001|Outcome|Correlation With CHOP-INTEND|Infants Diagnosed with SMN=2
10851934|NCT00309166|OG000|Outcome|Cervarix Group|Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
10851935|NCT00309166|OG001|Outcome|Engerix-B Group|Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
10851936|NCT00309166|EG000|Reported Event|Cervarix Group|Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
10851937|NCT00309166|EG001|Reported Event|Engerix-B Group|Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
10851938|NCT00309244|BG000|Baseline|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
10851939|NCT00309244|BG001|Baseline|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
10851940|NCT00309244|BG002|Baseline|Total|Total of all reporting groups
10851941|NCT00309244|FG000|Participant Flow|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder (administered at each meal) + subcutaneous insulin glargine (administered once daily at bedtime). Doses are individualized for each patient.
10851942|NCT00309244|FG001|Participant Flow|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart subcutaneous injection (rDNA origin), administered twice daily (before breakfast and before main evening meal). Doses are individualized for each patient.
10851943|NCT00309244|OG000|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
10851944|NCT00309244|OG001|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
10851945|NCT00309244|EG000|Reported Event|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
10851946|NCT00309244|EG001|Reported Event|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
10851947|NCT00309387|BG000|Baseline|Treatment|
10851948|NCT00309387|BG001|Baseline|Placebo|
11127003|NCT01736553|OG000|Outcome|Correlation With TIMPSI|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
10851949|NCT00309387|BG002|Baseline|Total|Total of all reporting groups
10851950|NCT00309387|FG000|Participant Flow|Treatment|
10851951|NCT00309387|FG001|Participant Flow|Placebo|
10851952|NCT00309387|OG000|Outcome|Treatment|Centrum
10851953|NCT00309387|OG001|Outcome|Placebo|Placebo
10851954|NCT00309387|OG001|Outcome|Placebo|placebo
10851955|NCT00309387|EG000|Reported Event|Treatment|
10851956|NCT00309387|EG001|Reported Event|Placebo|
10851957|NCT00309452|BG000|Baseline|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
10851958|NCT00309452|BG001|Baseline|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
10975383|NCT00935272|FG000|Participant Flow|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
11126232|NCT02478775|FG001|Participant Flow|Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.~Normal weight participants = 18.5 to 24.9 BMI"
10851959|NCT00309452|BG002|Baseline|Total|Total of all reporting groups
10851960|NCT00309452|FG000|Participant Flow|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
10851961|NCT00309452|FG001|Participant Flow|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
10851962|NCT00309452|OG000|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
10851963|NCT00309452|OG001|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
10851964|NCT00309452|EG000|Reported Event|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
10851965|NCT00309452|EG001|Reported Event|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
10851966|NCT00309465|BG000|Baseline|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
10851967|NCT00309465|BG001|Baseline|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their physician for the insulin glargine dose to administer the evening before surgery.
10975384|NCT00935272|FG001|Participant Flow|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
10851968|NCT00309465|BG002|Baseline|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual fasting blood glucose range was > or = 150 mg/dl.
10851969|NCT00309465|BG003|Baseline|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
10851970|NCT00309465|BG004|Baseline|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
10851971|NCT00309465|BG005|Baseline|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
10851972|NCT00309465|BG006|Baseline|Total|Total of all reporting groups
10851973|NCT00309465|FG000|Participant Flow|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
10851974|NCT00309465|FG001|Participant Flow|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
10851975|NCT00309465|FG002|Participant Flow|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose value was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was > or = 150 mg/dl.
10851976|NCT00309465|FG003|Participant Flow|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
11220547|NCT02334813|FG000|Participant Flow|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
11220548|NCT02334813|FG001|Participant Flow|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
10851977|NCT00309465|FG004|Participant Flow|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
10851978|NCT00309465|FG005|Participant Flow|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose value was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
10851979|NCT00309465|OG000|Outcome|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
10851980|NCT00309465|OG001|Outcome|Call Physician (Insulin Glargine Only Group)|Subjects called their own physicians for insulin glargine dose on the evening before surgery
10851981|NCT00309465|OG002|Outcome|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of their usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was > or = 150 mg/dl
10851982|NCT00309465|OG003|Outcome|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects self-administered 80% of the usual insulin glargine dose on the evening before surgery
10851983|NCT00309465|OG004|Outcome|Call Physician (Insulin Glargine Plus Bolus Group|Subjects called their own physicians for the insulin glargine dose to administer on the evening before surgery
10851984|NCT00309465|OG005|Outcome|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of their usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of their usual insulin glargine dose if midpoint of self-reported usual fasting blood glucose ragne was > or = 150 mg/dl
10851985|NCT00309465|EG000|Reported Event|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
10851986|NCT00309465|EG001|Reported Event|Call Physician (Insulin Glargine Only Group)|Subjects called physician for the insulin glargine dose on the evening before surgery.
10851987|NCT00309465|EG002|Reported Event|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose > or =150 mg/dl
10851988|NCT00309465|EG003|Reported Event|Take 80% (Insuling Glargine Plus Bolus Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
10851989|NCT00309465|EG004|Reported Event|Call Physician (Insulin Glargine Plus Bolus Group)|Subjects called physician for the insulin glargine dose to administer on the evening before surgery.
10851990|NCT00309465|EG005|Reported Event|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of usual insulin glargine if midpoint of usual self-reported fasting blood glucose was <150 mg/dl or (b) 100% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose was < or =150 mg/dl.
10851991|NCT00309608|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
10851992|NCT00309608|BG001|Baseline|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
10851993|NCT00309608|BG002|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
10851994|NCT00309608|BG003|Baseline|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
10851995|NCT00309608|BG004|Baseline|Glimepiride|Patients randomized to receive treatment with Glimepiride
10851996|NCT00309608|BG005|Baseline|Total|Total of all reporting groups
10851997|NCT00309608|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
10851998|NCT00309608|FG001|Participant Flow|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
10851999|NCT00309608|FG002|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
10852000|NCT00309608|FG003|Participant Flow|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
10852001|NCT00309608|FG004|Participant Flow|Glimepiride|Patients randomized to receive treatment with Glimepiride
10852002|NCT00309608|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
10852003|NCT00309608|OG001|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
10852004|NCT00309608|OG002|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
10852005|NCT00309608|OG003|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
10852006|NCT00309608|OG004|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
10852007|NCT00309608|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
10852008|NCT00309608|EG001|Reported Event|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
10852009|NCT00309608|EG002|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
10852010|NCT00309608|EG003|Reported Event|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
10852011|NCT00309608|EG004|Reported Event|Glimepiride|Patients randomized to receive treatment with Glimepiride
10852012|NCT00309738|BG000|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10852013|NCT00309738|BG001|Baseline|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
10852014|NCT00309738|BG002|Baseline|Total|Total of all reporting groups
10852015|NCT00309738|FG000|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10852016|NCT00309738|FG001|Participant Flow|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
10852017|NCT00309738|OG000|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10852018|NCT00309738|OG001|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
10852019|NCT00309738|EG000|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10852020|NCT00309738|EG001|Reported Event|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
10852021|NCT00309751|BG000|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10852022|NCT00309751|BG001|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
10852023|NCT00309751|BG002|Baseline|Total|Total of all reporting groups
10852024|NCT00309751|FG000|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10852025|NCT00309751|FG001|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
10852026|NCT00309751|OG000|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10852027|NCT00309751|OG001|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
10852028|NCT00309751|EG000|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10852029|NCT00309751|EG001|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
10852030|NCT00309777|BG000|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
10852031|NCT00309777|BG001|Baseline|Simvastatin 20 mg|Simvastatin 20 mg once daily
10852032|NCT00309777|BG002|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10852033|NCT00309777|BG003|Baseline|Simvastatin 40 mg|Simvastatn 40 mg once daily
10852034|NCT00309777|BG004|Baseline|Total|Total of all reporting groups
10852035|NCT00309777|FG000|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
10852036|NCT00309777|FG001|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg once daily
10852037|NCT00309777|FG002|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10852038|NCT00309777|FG003|Participant Flow|Simvastatin 40 mg|Simvastatn 40 mg once daily
10852039|NCT00309777|OG000|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
10852040|NCT00309777|OG001|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
10852041|NCT00309777|OG002|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10852042|NCT00309777|OG003|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
10852043|NCT00309777|EG000|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
10852044|NCT00309777|EG001|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg once daily
10852045|NCT00309777|EG002|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10852046|NCT00309777|EG003|Reported Event|Simvastatin 40 mg|Simvastatn 40 mg once daily
10852047|NCT00309842|BG000|Baseline|Unrelated UCBT for Blood Cancers|Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
10852048|NCT00309842|FG000|Participant Flow|Unrelated UCBT for Blood Cancers|Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
10852049|NCT00309842|OG000|Outcome|Unrelated UCBT for Blood Cancers|Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
11006986|NCT01088984|OG000|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
10852050|NCT00309842|EG000|Reported Event|Unrelated UCBT for Blood Cancers|Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
10852051|NCT00309907|BG000|Baseline|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
10852052|NCT00309907|FG000|Participant Flow|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
10852053|NCT00309907|OG000|Outcome|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
10852054|NCT00309907|OG000|Outcome|Etanercept and Corticosteroid Therapy|Regimen A
10852055|NCT00309907|EG000|Reported Event|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
10852056|NCT00309946|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
10852057|NCT00309946|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
10852058|NCT00309946|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
10852059|NCT00309946|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
10852060|NCT00309959|BG000|Baseline|ABI-007|ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
10852061|NCT00309959|FG000|Participant Flow|ABI-007|ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
10852062|NCT00309959|OG000|Outcome|ABI-007|ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
10852063|NCT00309959|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10852064|NCT00309959|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10852065|NCT00309959|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10852066|NCT00309959|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10852067|NCT00309959|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
11126233|NCT02478775|FG002|Participant Flow|Experimental: Frequent Blood Sampling, Cetrorelix: Obese|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.~Obese participants = BMI of >30"
10852068|NCT00309959|EG000|Reported Event|ABI-007|ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
10852069|NCT00310037|BG000|Baseline|Arm A Maintenance Therapy|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
10852070|NCT00310037|BG001|Baseline|Arm B Consolidation Therapy|Patients receive bortezomib 1.3 mg/m^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
11220549|NCT02334813|OG000|Outcome|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
11220550|NCT02334813|OG001|Outcome|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
11220551|NCT02334813|EG000|Reported Event|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
11220552|NCT02334813|EG001|Reported Event|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
11220553|NCT02334982|BG000|Baseline|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
11220554|NCT02334982|BG001|Baseline|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
11220555|NCT02334982|BG002|Baseline|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
11220556|NCT02334982|BG003|Baseline|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
11220557|NCT02334982|BG004|Baseline|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
10852071|NCT00310037|BG002|Baseline|Total|Total of all reporting groups
11127004|NCT01736553|OG001|Outcome|Correlation With CHOP-INTEND|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
11220558|NCT02334982|BG005|Baseline|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
11220559|NCT02334982|BG006|Baseline|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
11220560|NCT02334982|BG007|Baseline|Total|Total of all reporting groups
11220561|NCT02334982|FG000|Participant Flow|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
11220562|NCT02334982|FG001|Participant Flow|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
11220563|NCT02334982|FG002|Participant Flow|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
11220564|NCT02334982|FG003|Participant Flow|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
11220565|NCT02334982|FG004|Participant Flow|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
11220566|NCT02334982|FG005|Participant Flow|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
11220567|NCT02334982|FG006|Participant Flow|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
11220568|NCT02334982|OG000|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
11220569|NCT02334982|OG001|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
11343049|NCT03722524|BG000|Baseline|Patients With Arterial Hypertension|"The patient is included in the program if prior to the study his/her doctor decided to adjust treatment, targeted at the BP control improvement, by prescription of a triple FDC of amlodipine / indapamide / perindopril arginine. The prescription of the triple FDC of amlodipine / indapamide / perindopril arginine during the program is made by the doctor's decision according to the instructions for medical use of this FDC.~Presumably, each doctor will include 4 patients in average. It is planned to include 1,300 patients.~amlodipine / indapamide / perindopril arginine FDC: CCB / diuretic / ACE inhibitor"
11343050|NCT03722524|FG000|Participant Flow|Patients With Arterial Hypertension|"The patient is included in the program if prior to the study his/her doctor decided to adjust treatment, targeted at the BP control improvement, by prescription of a triple FDC of amlodipine / indapamide / perindopril arginine. The prescription of the triple FDC of amlodipine / indapamide / perindopril arginine during the program is made by the doctor's decision according to the instructions for medical use of this FDC.~Presumably, each doctor will include 4 patients in average. It is planned to include 1,300 patients.~amlodipine / indapamide / perindopril arginine FDC: CCB / diuretic / ACE inhibitor"
11220570|NCT02334982|OG002|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
11220571|NCT02334982|OG003|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
11220572|NCT02334982|OG004|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
11220573|NCT02334982|OG005|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
11220574|NCT02334982|OG006|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
11220575|NCT02334982|OG007|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
11220576|NCT02334982|OG005|Outcome|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
11220577|NCT02334982|OG005|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
11220578|NCT02334982|OG000|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10852072|NCT00310037|FG000|Participant Flow|Arm A Maintenance Therapy|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
10852073|NCT00310037|FG001|Participant Flow|Arm B Consolidation Therapy|Patients receive bortezomib 1.3 mg/m^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
10852074|NCT00310037|OG000|Outcome|Arm A Maintenance Therapy|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
10852075|NCT00310037|OG001|Outcome|Arm B Consolidation Therapy|Patients receive bortezomib 1.3 mg/m^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
10852076|NCT00310037|EG000|Reported Event|Arm A Maintenance Therapy|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
10852077|NCT00310037|EG001|Reported Event|Arm B Consolidation Therapy|Patients receive bortezomib 1.3 mg/m^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
10852078|NCT00310050|BG000|Baseline|Pemetrexed in Combination With Concomitant Radiotherapy|"Patients will receive Pemetrexed plus Radiotherapy.~pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).~Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments)."
10852079|NCT00310050|FG000|Participant Flow|Pemetrexed in Combination With Concomitant Radiotherapy|"Patients will receive Pemetrexed plus Radiotherapy.~pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).~Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments)."
10852080|NCT00310050|OG000|Outcome|Pemetrexed in Combination With Concomitant Radiotherapy|"Patients will receive Pemetrexed plus Radiotherapy.~pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).~Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments)."
10975385|NCT00935272|OG000|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
10975386|NCT00935272|OG001|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
10975387|NCT00935272|EG000|Reported Event|Treatment With Restylane|Safety included post treatment assessment, and assessments at each visit throughout the study.
10975388|NCT00935272|EG001|Reported Event|No Treatment|Safety included post treatment assessment, and assessments at each visit throughout the study.
10975389|NCT00935272|EG002|Reported Event|Second Treatment|At Week 24, subjects who were initially randomized to treatment were offered an optional second treatment with Restylane. In addition those randomized to non-treatment were offered their first treatment of Restylane at week 24. The safety from this set was followed to one month after the treatment.
10975390|NCT00935311|BG000|Baseline|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
10975391|NCT00935311|BG001|Baseline|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
10975392|NCT00935311|BG002|Baseline|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
10975393|NCT00935311|BG003|Baseline|Total|Total of all reporting groups
10975394|NCT00935311|FG000|Participant Flow|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
10975395|NCT00935311|FG001|Participant Flow|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
10975396|NCT00935311|FG002|Participant Flow|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
10975397|NCT00935311|OG000|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
11126234|NCT02478775|OG000|Outcome|Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.~Normal weight participants = 18.5 to 24.9 BMI"
10975398|NCT00935311|OG001|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
10975399|NCT00935311|OG002|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
10852081|NCT00310050|EG000|Reported Event|Pemetrexed in Combination With Concomitant Radiotherapy|"Patients will receive Pemetrexed plus Radiotherapy.~pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).~Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments)."
10852082|NCT00310076|BG000|Baseline|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
10852083|NCT00310076|FG000|Participant Flow|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
10852084|NCT00310076|OG000|Outcome|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
10852085|NCT00310076|EG000|Reported Event|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
10852086|NCT00310310|BG000|Baseline|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
10852087|NCT00310310|BG001|Baseline|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
10852088|NCT00310310|BG002|Baseline|Total|Total of all reporting groups
10852089|NCT00310310|FG000|Participant Flow|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
10852090|NCT00310310|FG001|Participant Flow|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
10852091|NCT00310310|OG000|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
10852092|NCT00310310|OG001|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
10852093|NCT00310310|EG000|Reported Event|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
10852094|NCT00310310|EG001|Reported Event|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
10852095|NCT00310362|BG000|Baseline|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
10852096|NCT00310362|BG001|Baseline|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures..
10852097|NCT00310362|BG002|Baseline|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
10852098|NCT00310362|BG003|Baseline|Total|Total of all reporting groups
10852099|NCT00310362|FG000|Participant Flow|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
10852100|NCT00310362|FG001|Participant Flow|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
10852101|NCT00310362|FG002|Participant Flow|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
10852102|NCT00310362|OG000|Outcome|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
10852103|NCT00310362|OG001|Outcome|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
10852104|NCT00310362|OG002|Outcome|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
10852105|NCT00310362|OG000|Outcome|Usual Care With Nurse Phone Call|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
10852106|NCT00310362|OG001|Outcome|Interactive Voice Response 3 Days Prior|IVR3-Interactive voice response system was used to remind patients 3 days before a scheduled appointment and to educate them about preparation procedures for the appointment
10852107|NCT00310362|OG002|Outcome|Interactive Voice Response 7 Days Prior|IVR7-Interactive voice response system was used to remind patients 7 days before a scheduled appointment and to educate them about preparation procedures for the appointment
11126235|NCT02478775|OG001|Outcome|Experimental: Frequent Blood Sampling, Cetrorelix: Obese|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.~Obese participants = BMI of >30"
10852108|NCT00310362|OG000|Outcome|Usual Care With Nurse Phone Call|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions about bowel prep procedures.
10975400|NCT00935311|EG000|Reported Event|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
10852109|NCT00310362|OG001|Outcome|Interactive Voice Response 3 Days Prior|IVR3-Interactive voice response system was used to remind patients 3 days before a scheduled appointment and to educate them about bowel preparation procedures for the appointment
10852110|NCT00310362|OG002|Outcome|Interactive Voice Response 7 Days Prior|IVR7-Interactive voice response system was used to remind patients 7 days before a scheduled appointment and to educate them about bowel preparation procedures for the appointment
10852111|NCT00310362|EG000|Reported Event|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
10852112|NCT00310362|EG001|Reported Event|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
10852113|NCT00310362|EG002|Reported Event|IVR7|Arm 2 (IVR3) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
10852114|NCT00310375|BG000|Baseline|Placebo in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.
10852115|NCT00310375|BG001|Baseline|Retigabine in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.
10852116|NCT00310375|BG002|Baseline|Total|Total of all reporting groups
10852117|NCT00310375|FG000|Participant Flow|Placebo in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.
10852118|NCT00310375|FG001|Participant Flow|Retigabine in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.
10852119|NCT00310375|FG002|Participant Flow|Safety Follow-up Continuation Phase (SFUCP)|Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
10852120|NCT00310375|OG000|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
10852121|NCT00310375|OG000|Outcome|Overall Study|
10852122|NCT00310375|OG000|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
10852123|NCT00310375|OG000|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
10852124|NCT00310375|OG000|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
10852125|NCT00310375|OG000|Outcome|Retigabine SFUCP|Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
10852126|NCT00310375|EG000|Reported Event|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
10852127|NCT00310401|BG000|Baseline|Albuterol|
10852128|NCT00310401|BG001|Baseline|Saline|
10852129|NCT00310401|BG002|Baseline|Total|Total of all reporting groups
10852130|NCT00310401|FG000|Participant Flow|Albuterol|
10852131|NCT00310401|FG001|Participant Flow|Saline|
10852132|NCT00310401|OG000|Outcome|Albuterol|Albuterol 5 mg every 4 hour by nebulization
10852133|NCT00310401|OG001|Outcome|Saline|Saline every 4 hours by nebulization
11127005|NCT01736553|OG000|Outcome|Correlation With TIMPSI|Infants diagnosed with SMA (SMN=2)
11127006|NCT01736553|OG001|Outcome|Correlation With CHOP-INTEND|Infants diagnosed with SMA (SMN=2)
10852134|NCT00310401|OG000|Outcome|Albuterol|Albuterol: 5 mg nebulized q4h
10852135|NCT00310401|OG001|Outcome|Saline|Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
10852136|NCT00310401|EG000|Reported Event|Albuterol|
10852137|NCT00310401|EG001|Reported Event|Saline|
10852138|NCT00310427|BG000|Baseline|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
10852139|NCT00310427|BG001|Baseline|Placebo|Subjects received placebo orally on a daily basis.
10852140|NCT00310427|BG002|Baseline|Total|Total of all reporting groups
10852141|NCT00310427|FG000|Participant Flow|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
10852142|NCT00310427|FG001|Participant Flow|Placebo|Subjects received placebo orally on a daily basis.
10852143|NCT00310427|OG000|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
10852144|NCT00310427|OG001|Outcome|Placebo|Subjects received placebo orally on a daily basis.
10852145|NCT00310427|EG000|Reported Event|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
10852146|NCT00310427|EG001|Reported Event|Placebo|Subjects received placebo orally on a daily basis.
10852147|NCT00310440|BG000|Baseline|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
10852148|NCT00310440|BG001|Baseline|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
10852149|NCT00310440|BG002|Baseline|Total|Total of all reporting groups
10852150|NCT00310440|FG000|Participant Flow|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
10852151|NCT00310440|FG001|Participant Flow|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
10852152|NCT00310440|OG000|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
10852153|NCT00310440|OG001|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
10852154|NCT00310440|EG000|Reported Event|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
10852155|NCT00310440|EG001|Reported Event|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
11126236|NCT02478775|EG000|Reported Event|Experimental: Frequent Blood Sampling, Degarelix|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.~BMI = 18.5 to 24.9 BMI"
10852156|NCT00310466|BG000|Baseline|SLITone Birch|Birch pollen extract for sublingual administration
10852157|NCT00310466|BG001|Baseline|Placebo|Corresponding placebo for sublingual administration
10852158|NCT00310466|BG002|Baseline|Total|Total of all reporting groups
10852159|NCT00310466|FG000|Participant Flow|SLITone Birch|Birch pollen extract for sublingual administration
10852160|NCT00310466|FG001|Participant Flow|Placebo|Corresponding placebo for sublingual administration
10852161|NCT00310466|OG000|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
10852162|NCT00310466|OG001|Outcome|Placebo|Corresponding placebo for sublingual administration
10852163|NCT00310466|EG000|Reported Event|SLITone Birch|Birch pollen extract for sublingual administration
10852164|NCT00310466|EG001|Reported Event|Placebo|Corresponding placebo for sublingual administration
10852165|NCT00310791|BG000|Baseline|Placebo|
10852166|NCT00310791|BG001|Baseline|Active|
10852167|NCT00310791|BG002|Baseline|Total|Total of all reporting groups
10852168|NCT00310791|FG000|Participant Flow|Placebo|
10852169|NCT00310791|FG001|Participant Flow|Active|
10852170|NCT00310791|OG000|Outcome|Placebo|Sugar Pill
10852171|NCT00310791|OG001|Outcome|Active|DHEA+HRT
10852172|NCT00310791|EG000|Reported Event|Placebo|
10852173|NCT00310791|EG001|Reported Event|Active|
10852174|NCT00310804|BG000|Baseline|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
10852175|NCT00310804|BG001|Baseline|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
10852176|NCT00310804|BG002|Baseline|Total|Total of all reporting groups
10852177|NCT00310804|FG000|Participant Flow|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
10852178|NCT00310804|FG001|Participant Flow|TIV Group|Subjects in this group received one dose of Egg derived Trivalent Subunit Influenza Vaccine (TIV).
10852179|NCT00310804|OG000|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
10852180|NCT00310804|OG001|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
10852181|NCT00310804|OG002|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
10852182|NCT00310804|OG003|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
10852183|NCT00310804|OG004|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
10852184|NCT00310804|OG000|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
10852185|NCT00310804|OG001|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
10852186|NCT00310804|OG004|Outcome|TIV Group|Subjects in this group received one dose of Egg-Derived Trivalent Subunit Influenza Vaccine(TIV).
10852187|NCT00310804|OG000|Outcome|cTIV_lot 1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
10852188|NCT00310804|OG002|Outcome|cTIV_lot 3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
10852189|NCT00310804|OG002|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from lot 3.
10852190|NCT00310804|OG001|Outcome|cTIV_lot2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
10852191|NCT00310804|OG000|Outcome|cTIV (Combined) Day 1 to Day 22|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot 1, Lot2 or Lot3).
11220579|NCT02334982|OG001|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
11220580|NCT02334982|OG002|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10852192|NCT00310804|OG001|Outcome|cTIV (Combined) Day 23 to Day 181|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
10852193|NCT00310804|OG002|Outcome|TIV Group Day 1 to Day 22|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
10852194|NCT00310804|OG003|Outcome|TIV Group Day 23 to Day 181|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
10852195|NCT00310804|EG000|Reported Event|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
10975401|NCT00935311|EG001|Reported Event|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
11220581|NCT02334982|OG003|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
11220582|NCT02334982|OG004|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10852196|NCT00310804|EG001|Reported Event|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
10852197|NCT00310817|BG000|Baseline|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
10852198|NCT00310817|BG001|Baseline|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
10852199|NCT00310817|BG002|Baseline|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
10852200|NCT00310817|BG003|Baseline|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
10852201|NCT00310817|BG004|Baseline|Total|Total of all reporting groups
10852202|NCT00310817|FG000|Participant Flow|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
10852203|NCT00310817|FG001|Participant Flow|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
10852204|NCT00310817|FG002|Participant Flow|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
10852205|NCT00310817|FG003|Participant Flow|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
10852206|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
10852207|NCT00310817|OG001|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.
10975402|NCT00935311|EG002|Reported Event|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
11220583|NCT02334982|OG005|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
11220584|NCT02334982|OG006|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
11220585|NCT02334982|EG000|Reported Event|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
11220586|NCT02334982|EG001|Reported Event|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
11220587|NCT02334982|EG002|Reported Event|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10852208|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337
10852209|NCT00310817|OG001|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
10852210|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
10852211|NCT00310817|OG001|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
10852212|NCT00310817|OG002|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
10852213|NCT00310817|OG003|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
10852214|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad)- (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
10852215|NCT00310817|OG001|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
10852216|NCT00310817|OG003|Outcome|MeMenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
10852217|NCT00310817|OG002|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) on day 169 (6 months after first vaccination).
10852218|NCT00310817|OG003|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
10852219|NCT00310817|OG003|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
10852220|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
10852221|NCT00310817|OG001|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
10852222|NCT00310817|OG001|Outcome|MenACWY-CRM( Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
10852223|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine with on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
10852224|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
10852225|NCT00310817|OG001|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
10852226|NCT00310817|OG000|Outcome|MenACWY-CRM (Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
10852227|NCT00310817|OG001|Outcome|MenACWY-CRM (Ad-)12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
10852228|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
10852229|NCT00310817|OG001|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
10852230|NCT00310817|OG002|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
10852231|NCT00310817|OG003|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
10852232|NCT00310817|OG003|Outcome|MenACWY-CRM(Ad-) (12-35M12- )|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
10852233|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
10852234|NCT00310817|OG001|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
10852235|NCT00310817|OG002|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
10852236|NCT00310817|OG003|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
10852237|NCT00310817|OG002|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MEnACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
10852238|NCT00310817|OG003|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MEnACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
10852239|NCT00310817|OG000|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
10852240|NCT00310817|OG001|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
10852241|NCT00310817|OG002|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
10852242|NCT00310817|OG003|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
10852243|NCT00310817|EG000|Reported Event|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+)vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
10852244|NCT00310817|EG001|Reported Event|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
10852245|NCT00310817|EG002|Reported Event|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 169 or day 337.
10852246|NCT00310817|EG003|Reported Event|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
10852247|NCT00310856|BG000|Baseline|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
10852248|NCT00310856|BG001|Baseline|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
10852249|NCT00310856|BG002|Baseline|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
10975403|NCT00935428|BG000|Baseline|Patients Injured|
10975404|NCT00935428|FG000|Participant Flow|Patients Injured|Those patients evaluated at OHSU Hospital with horse related injuries
10975405|NCT00935428|OG000|Outcome|Patients Injured|All patients evaluated at OHSU Hospital with horse-related injuries
10975406|NCT00935428|OG000|Outcome|Helmet Use|Those patients wearing a helmet at the time of injury
10975407|NCT00935428|OG000|Outcome|Preventable Head Injury|Those patients not wearing a helmet at the time of injury who developed a head injury
10975408|NCT00935428|OG000|Outcome|Long Term Disability|Those participants who responded to a survey indicating they suffered long term disability
11220588|NCT02334982|EG003|Reported Event|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10975409|NCT00935428|OG000|Outcome|Poor Environmental Factors|Those patients who stated that poor environmental factors led to the injury
10975410|NCT00935428|OG001|Outcome|Poor Horse and Rider Pairing|Those patients who stated poor horse and rider pairing led to the injury
10975411|NCT00935428|OG002|Outcome|Equipment Failure|Those patients who stated equipment failure led to the injury
10975412|NCT00935428|EG000|Reported Event|Participants|Patients evaluated at OHSU Hospital with horse related injuries
10975413|NCT00935493|BG000|Baseline|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
10975414|NCT00935493|BG001|Baseline|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
10852250|NCT00310856|BG003|Baseline|Total|Total of all reporting groups
10852251|NCT00310856|FG000|Participant Flow|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
10975415|NCT00935493|BG002|Baseline|Placebo po Qhs|Placebo: Placebo po qhs
10975416|NCT00935493|BG003|Baseline|Total|Total of all reporting groups
10975417|NCT00935493|FG000|Participant Flow|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
10975418|NCT00935493|FG001|Participant Flow|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
10975419|NCT00935493|FG002|Participant Flow|Placebo po Qhs|Placebo: Placebo po qhs
10975420|NCT00935493|OG000|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
10975421|NCT00935493|OG001|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
10975422|NCT00935493|OG002|Outcome|Placebo|Placebo: Placebo
10975423|NCT00935493|EG000|Reported Event|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
10975424|NCT00935493|EG001|Reported Event|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
10975425|NCT00935493|EG002|Reported Event|Placebo|Placebo: Placebo
10975426|NCT00935532|BG000|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
10975427|NCT00935532|BG001|Baseline|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
10975428|NCT00935532|BG002|Baseline|Total|Total of all reporting groups
10975429|NCT00935532|FG000|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
10975430|NCT00935532|FG001|Participant Flow|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
10975431|NCT00935532|OG000|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
10975432|NCT00935532|OG001|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
10975433|NCT00935532|EG000|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
10975434|NCT00935532|EG001|Reported Event|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
10975435|NCT00935584|BG000|Baseline|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
10975436|NCT00935584|BG001|Baseline|PACE Study Providers|23 providers participated in the study. However, final analysis was based on 126 clinic visits.
10975437|NCT00935584|BG002|Baseline|Total|Total of all reporting groups
10975438|NCT00935584|FG000|Participant Flow|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design). Pre-intervention phase consisted of baseline data collection on EMR usage and patient-physician communication.~126 patients started the study and 77 completed the study."
10975439|NCT00935584|FG001|Participant Flow|PACE Study Providers|23 primary care providers started and 19 completed the study. 22 primary care providers participated in the educational workshop.
11220589|NCT02334982|EG004|Reported Event|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
11220590|NCT02334982|EG005|Reported Event|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
10852252|NCT00310856|FG001|Participant Flow|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
10852253|NCT00310856|FG002|Participant Flow|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).~Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
10852254|NCT00310856|OG000|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
10852255|NCT00310856|OG001|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
10852256|NCT00310856|OG000|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
10852257|NCT00310856|OG002|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
10852258|NCT00310856|EG000|Reported Event|MenACWY-CRM_6-12M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
10852259|NCT00310856|EG001|Reported Event|MenACWY-CRM_12M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
10852260|NCT00310856|EG002|Reported Event|MenC-CRM_12M_MenACWY-CRM_18M|Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months)
11220591|NCT02334982|EG006|Reported Event|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
11220592|NCT02334982|EG007|Reported Event|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
10852261|NCT00311155|BG000|Baseline|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
10852262|NCT00311155|FG000|Participant Flow|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
10852263|NCT00311155|OG000|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
10852264|NCT00311155|EG000|Reported Event|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
10852265|NCT00311168|BG000|Baseline|VIP On, Then VIP Off|"Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.~Intervention/treatment:~Device: VIP On Device: VIP Off"
10852266|NCT00311168|BG001|Baseline|VIP Off, Then VIP On|"Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.~Intervention/treatment:~Device: VIP On Device: VIP Off"
10852267|NCT00311168|BG002|Baseline|Total|Total of all reporting groups
10852268|NCT00311168|FG000|Participant Flow|VIP On, Then VIP Off|"Participants first have the VIP algorithm programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.~Intervention/treatment:~Device: VIP On Device: VIP Off"
11006987|NCT01088984|OG000|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
10852269|NCT00311168|FG001|Participant Flow|VIP Off, Then VIP On|"Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.~Intervention/treatment:~Device: VIP Off Device: VIP On"
10852270|NCT00311168|OG000|Outcome|VIP On|"VIP On Group~VIP On, then VIP Off~VIP Off, then VIP On"
10852271|NCT00311168|OG001|Outcome|VIP Off|"VIP Off Group~VIP On, then VIP Off~VIP Off, then VIP On"
10852272|NCT00311168|OG000|Outcome|VIP On|VIP On Period
10852273|NCT00311168|OG001|Outcome|VIP Off|VIP Off Period
10852274|NCT00311168|EG000|Reported Event|VIP On|VIP On Period
11006988|NCT01088984|OG001|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
10852275|NCT00311168|EG001|Reported Event|VIP Off|VIP Off Period
10852276|NCT00311181|BG000|Baseline|Group 1|
10852277|NCT00311181|FG000|Participant Flow|Group 1|
10852278|NCT00311181|OG000|Outcome|Group 1|
10852279|NCT00311181|EG000|Reported Event|Group 1|
10852280|NCT00311246|BG000|Baseline|An Open-label|"Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52~Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks."
10852281|NCT00311246|FG000|Participant Flow|An Open-label|"Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52~Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks."
10852282|NCT00311246|OG000|Outcome|An Open-label|"Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52~Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks."
10975440|NCT00935584|OG000|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
11127007|NCT01736553|EG000|Reported Event|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
10852283|NCT00311246|OG000|Outcome|Borg Dyspnea Scores|This scale was used to measure a patients breathlessness before/after the 6 Minute Walk at Screening and at 24 weeks.
10852284|NCT00311246|OG000|Outcome|Physicians Global Assessment|
10852285|NCT00311246|OG000|Outcome|Patients Global Assessment|
10852286|NCT00311246|EG000|Reported Event|An Open-label|"Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52~Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.~There were no adverse events."
10852287|NCT00311311|BG000|Baseline|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
10852288|NCT00311311|BG001|Baseline|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
10852289|NCT00311311|BG002|Baseline|Total|Total of all reporting groups
10852290|NCT00311311|FG000|Participant Flow|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 nanogram per milliliter [ng/mL] by 3-6 months post-transplant) plus mycophenolate mofetil (MMF) (greater than or equal to [>=] 500 milligram per day [mg/day]) or mycophenolate sodium (MPS) (>= 360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or azathioprine (AZA) (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
10852291|NCT00311311|FG001|Participant Flow|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to cyclosporine (CsA) (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
10852292|NCT00311311|OG000|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
10852293|NCT00311311|OG001|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
10852294|NCT00311311|EG000|Reported Event|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
10852295|NCT00311311|EG001|Reported Event|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
10852296|NCT00311363|BG000|Baseline|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
10852297|NCT00311363|BG001|Baseline|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
10852298|NCT00311363|BG002|Baseline|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
10852299|NCT00311363|BG003|Baseline|Total|Total of all reporting groups
10852300|NCT00311363|FG000|Participant Flow|Single-blind (SB) GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
10852301|NCT00311363|FG001|Participant Flow|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
10852302|NCT00311363|FG002|Participant Flow|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
10975441|NCT00935584|EG000|Reported Event|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
10852303|NCT00311363|OG000|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
10852304|NCT00311363|OG001|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
10852305|NCT00311363|OG001|Outcome|GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
10852306|NCT00311363|OG001|Outcome|DB GEn 1200mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
10852307|NCT00311363|OG000|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
10975442|NCT00935701|BG000|Baseline|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
10852308|NCT00311363|EG000|Reported Event|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
10852309|NCT00311363|EG001|Reported Event|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
10852310|NCT00311363|EG002|Reported Event|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
10852311|NCT00311376|BG000|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
10852312|NCT00311376|BG001|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10852313|NCT00311376|BG002|Baseline|Placebo|Normal saline (placebo)
10852314|NCT00311376|BG003|Baseline|Total|Total of all reporting groups
10852315|NCT00311376|FG000|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
10852316|NCT00311376|FG001|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10852317|NCT00311376|FG002|Participant Flow|Placebo|Normal saline (placebo)
10852318|NCT00311376|OG000|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
10852319|NCT00311376|OG001|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10852320|NCT00311376|OG002|Outcome|Placebo|Normal saline (placebo)
10852321|NCT00311376|EG000|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
10852322|NCT00311376|EG001|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10852323|NCT00311376|EG002|Reported Event|Placebo|Normal saline (placebo)
10852324|NCT00311402|BG000|Baseline|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
10852325|NCT00311402|BG001|Baseline|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
10852326|NCT00311402|BG002|Baseline|Total|Total of all reporting groups
10852327|NCT00311402|FG000|Participant Flow|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
10852328|NCT00311402|FG001|Participant Flow|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
10852329|NCT00311402|OG000|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
10852330|NCT00311402|OG001|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
10852331|NCT00311402|EG000|Reported Event|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
10852332|NCT00311402|EG001|Reported Event|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
10852333|NCT00311584|BG000|Baseline|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
10852334|NCT00311584|BG001|Baseline|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
10852335|NCT00311584|BG002|Baseline|Total|Total of all reporting groups
10852336|NCT00311584|FG000|Participant Flow|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
10852337|NCT00311584|FG001|Participant Flow|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
10852338|NCT00311584|OG000|Outcome|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
10852339|NCT00311584|OG001|Outcome|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
10852340|NCT00311584|EG000|Reported Event|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
10852341|NCT00311584|EG001|Reported Event|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
10852342|NCT00311623|BG000|Baseline|Control Group|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Receive no intervention on Days 1-14. Surgery performed on Day 15.~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852343|NCT00311623|BG001|Baseline|Low-dose Rapamycin (3mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 3mg: Rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
11006989|NCT01088984|OG002|Outcome|Total|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
11006990|NCT01088984|OG000|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
11006991|NCT01088984|OG001|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
11006992|NCT01088984|EG000|Reported Event|Bendamustine|Bendamustine 90 or 120 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
11006993|NCT01088997|BG000|Baseline|High Dose Milrinone|Subjects received a 50mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5mcg/kg over 24 hours
10852344|NCT00311623|BG002|Baseline|High-dose Rapamycin (6mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 6mg: Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
11220593|NCT02335125|BG000|Baseline|Intervention|"The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Psychotropic Drugs~Care Management"
10852345|NCT00311623|BG003|Baseline|Total|Total of all reporting groups
10852346|NCT00311623|FG000|Participant Flow|Control Group|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Receive no intervention on Days 1-14. Surgery performed on Day 15.~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852347|NCT00311623|FG001|Participant Flow|Low-dose Rapamycin (3mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 3mg: Rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852348|NCT00311623|FG002|Participant Flow|High-dose Rapamycin (6mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 6mg: Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852349|NCT00311623|OG000|Outcome|Control Group|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Receive no intervention on Days 1-14. Surgery performed on Day 15.~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852350|NCT00311623|OG001|Outcome|Low-dose Rapamycin (3mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 3mg: Rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852351|NCT00311623|OG002|Outcome|High-dose Rapamycin (6mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 6mg: Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852352|NCT00311623|OG000|Outcome|High-dose Rapamycin (6mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 6mg: Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
11127008|NCT01736553|EG001|Reported Event|Healthy Controls|Healthy control infants
11006994|NCT01088997|BG001|Baseline|Low Dose Milrinone|Subjects received a 20mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2mcg/kg over 24 hours
11006995|NCT01088997|BG002|Baseline|Total|Total of all reporting groups
11006996|NCT01088997|FG000|Participant Flow|High Dose Milrinone|Subjects received a 50 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5 mcg/kg/min over 24 hours.
10975443|NCT00935701|FG000|Participant Flow|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
10975444|NCT00935701|OG000|Outcome|Primary Group|Phase 1
10975445|NCT00935701|OG000|Outcome|Primary Group|
10975446|NCT00935701|EG000|Reported Event|Primary Group|
10975447|NCT00935766|BG000|Baseline|Placebo|Placebo (Four 1-gram capsules daily)
10975448|NCT00935766|BG001|Baseline|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
10975449|NCT00935766|BG002|Baseline|Total|Total of all reporting groups
10975450|NCT00935766|FG000|Participant Flow|Placebo|Placebo (Four 1-gram capsules daily)
10975451|NCT00935766|FG001|Participant Flow|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
10975452|NCT00935766|OG000|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
10975453|NCT00935766|OG001|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
10975454|NCT00935766|EG000|Reported Event|Placebo|Placebo (Four 1-gram capsules daily)
10975455|NCT00935766|EG001|Reported Event|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
10975456|NCT00935792|BG000|Baseline|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975457|NCT00935792|BG001|Baseline|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975458|NCT00935792|BG002|Baseline|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975459|NCT00935792|BG003|Baseline|Total|Total of all reporting groups
10975460|NCT00935792|FG000|Participant Flow|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
11126237|NCT02478775|EG001|Reported Event|Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.~Normal weight participants = 18.5 to 24.9 BMI"
11220594|NCT02335125|BG001|Baseline|Usual Care|Only standard care practices will be administered to this arm.
10975461|NCT00935792|FG001|Participant Flow|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975462|NCT00935792|FG002|Participant Flow|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975463|NCT00935792|OG000|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975464|NCT00935792|OG001|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975465|NCT00935792|OG002|Outcome|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975466|NCT00935792|OG000|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975467|NCT00935792|OG000|Outcome|All Evaluable Patients|Patients are only evaluable for duration of response when they have already been noted as a complete response or partial response.
10975468|NCT00935792|EG000|Reported Event|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975469|NCT00935792|EG001|Reported Event|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975470|NCT00935792|EG002|Reported Event|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
10975471|NCT00935818|BG000|Baseline|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
10975472|NCT00935818|BG001|Baseline|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
10975473|NCT00935818|BG002|Baseline|Total|Total of all reporting groups
10975474|NCT00935818|FG000|Participant Flow|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
10975475|NCT00935818|FG001|Participant Flow|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
11220595|NCT02335125|BG002|Baseline|Total|Total of all reporting groups
10852353|NCT00311623|EG000|Reported Event|Control Group|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Receive no intervention on Days 1-14. Surgery performed on Day 15.~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852354|NCT00311623|EG001|Reported Event|Low-dose Rapamycin (3mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 3mg: Rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852355|NCT00311623|EG002|Reported Event|High-dose Rapamycin (6mg)|"Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy.~Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer.~Will receive rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Rapamycin 6mg: Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).~Radical prostatectomy: Radical prostatectomy performed on Day 15"
10852356|NCT00311766|BG000|Baseline|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
10852357|NCT00311766|BG001|Baseline|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
10852358|NCT00311766|BG002|Baseline|Total|Total of all reporting groups
10852359|NCT00311766|FG000|Participant Flow|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
10852360|NCT00311766|FG001|Participant Flow|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
10852361|NCT00311766|OG000|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
10852362|NCT00311766|OG001|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
10852363|NCT00311766|EG000|Reported Event|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
10852364|NCT00311766|EG001|Reported Event|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
10852365|NCT00312195|BG000|Baseline|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
10852366|NCT00312195|BG001|Baseline|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
10852367|NCT00312195|BG002|Baseline|Total|Total of all reporting groups
10852368|NCT00312195|FG000|Participant Flow|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
10975476|NCT00935818|OG000|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
11098306|NCT01575522|EG000|Reported Event|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11098307|NCT01575561|BG000|Baseline|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
11098308|NCT01575561|FG000|Participant Flow|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
11098309|NCT01575561|OG000|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
11098310|NCT01575561|EG000|Reported Event|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
10852369|NCT00312195|FG001|Participant Flow|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
10852370|NCT00312195|OG000|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
10852371|NCT00312195|OG001|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
10852372|NCT00312195|OG002|Outcome|Total|Placebo and BTDS combined.
10852373|NCT00312195|EG000|Reported Event|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
10852374|NCT00312195|EG001|Reported Event|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
10975477|NCT00935818|OG001|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
10975478|NCT00935818|EG000|Reported Event|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
10975479|NCT00935818|EG001|Reported Event|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
10975480|NCT00935857|BG000|Baseline|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
10975481|NCT00935857|BG001|Baseline|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
10975482|NCT00935857|BG002|Baseline|Total|Total of all reporting groups
10975483|NCT00935857|FG000|Participant Flow|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
10975484|NCT00935857|FG001|Participant Flow|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
10975485|NCT00935857|OG000|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
10975486|NCT00935857|OG001|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
10975487|NCT00935857|EG000|Reported Event|Standard Colonoscopy|Patients who are randomized to received standard colonoscopy as initial treatment.
11220596|NCT02335125|FG000|Participant Flow|Intervention|"The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Psychotropic Drugs~Care Management"
10975488|NCT00935857|EG001|Reported Event|Single Balloon Colonoscopy|Patients who are randomized to received single balloon colonoscopy as initial treatment.
10975489|NCT00935883|BG000|Baseline|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
11098311|NCT01575756|BG000|Baseline|Full Analysis Set|All randomised participants who received at least 1 infusion of study medication (Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)) and for whom any post-treatment data were available.
11098312|NCT01575756|FG000|Participant Flow|Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM)|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once followed by Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once 45 days later.
10975490|NCT00935883|BG001|Baseline|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
11098313|NCT01575756|FG001|Participant Flow|Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA®|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once followed by Octafibrin/FIBRYGA® 70 mg/kg BW intravenously once 45 days later.
10975491|NCT00935883|BG002|Baseline|Total|Total of all reporting groups
10975492|NCT00935883|FG000|Participant Flow|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
10975493|NCT00935883|FG001|Participant Flow|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
11098314|NCT01575756|OG000|Outcome|Pharmacokinetic (PK)-Per Protocol Dataset|Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
11098315|NCT01575756|OG000|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
11098316|NCT01575756|OG001|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
11098317|NCT01575756|EG000|Reported Event|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
10975494|NCT00935883|OG000|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
10975495|NCT00935883|OG001|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
10975496|NCT00935883|EG000|Reported Event|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
10975497|NCT00935883|EG001|Reported Event|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
10975498|NCT00936065|BG000|Baseline|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
10975499|NCT00936065|BG001|Baseline|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
10975500|NCT00936065|BG002|Baseline|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
10975501|NCT00936065|BG003|Baseline|Total|Total of all reporting groups
10975502|NCT00936065|FG000|Participant Flow|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
11220597|NCT02335125|FG001|Participant Flow|Usual Care|Only standard care practices will be administered to this arm.
10975503|NCT00936065|FG001|Participant Flow|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
10975504|NCT00936065|FG002|Participant Flow|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
10975505|NCT00936065|OG000|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
10975506|NCT00936065|OG001|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
10975507|NCT00936065|OG002|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
10975508|NCT00936065|EG000|Reported Event|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
10975509|NCT00936065|EG001|Reported Event|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
10975510|NCT00936065|EG002|Reported Event|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
11006997|NCT01088997|FG001|Participant Flow|Low Dose Milrinone|Subjects received a 20 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2 mcg/kg/min over 24 hours.
11006998|NCT01088997|OG000|Outcome|High Dose Milrinone|7 subjects were enrolled into this arm, of these only 4 completed study treatment.
11006999|NCT01088997|OG001|Outcome|Low Dose Milrinone|5 subjects were enrolled into this arm, of these only 2 completed study treatment.
11007000|NCT01088997|OG000|Outcome|Milrinone Population|Population model developed based on 6 subjects who completed study treatment and were deemed evaluable.
11007001|NCT01088997|OG000|Outcome|High Dose Milrinone|7 subjects were enrolled into the study, of these 4 completed study treatment.
11007002|NCT01088997|OG001|Outcome|Low Dose Milrinone|5 subjects were enrolled into the study, of these 2 completed study treatment and only 1 received 2 MPI measurements
11007003|NCT01088997|EG000|Reported Event|High Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours.
11007004|NCT01088997|EG001|Reported Event|Low Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours.
11007005|NCT01089023|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
11007006|NCT01089023|FG000|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions.
11007007|NCT01089023|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
10852375|NCT00312195|EG002|Reported Event|Open-label Run-in Period BTDS 5, 10 or 20|Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
10975511|NCT00936117|BG000|Baseline|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
10975512|NCT00936117|FG000|Participant Flow|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
10975513|NCT00936117|OG000|Outcome|Posaconazole (Females)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
10975514|NCT00936117|OG001|Outcome|Posaconazole (Males)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
10975515|NCT00936117|EG000|Reported Event|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
11098318|NCT01575756|EG001|Reported Event|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
10975516|NCT00936208|BG000|Baseline|Micardis 80mg|One tablet of Micardis 80mg per day
10975517|NCT00936208|BG001|Baseline|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
10975518|NCT00936208|BG002|Baseline|Total|Total of all reporting groups
10975519|NCT00936208|FG000|Participant Flow|Micardis 80mg|One tablet of Micardis 80mg per day
10975520|NCT00936208|FG001|Participant Flow|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
10975521|NCT00936208|OG000|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
10975522|NCT00936208|OG001|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
10975523|NCT00936208|EG000|Reported Event|Micardis 80mg|One tablet of Micardis 80mg per day
10975524|NCT00936208|EG001|Reported Event|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
10975525|NCT00936221|BG000|Baseline|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
10975526|NCT00936221|BG001|Baseline|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
10975527|NCT00936221|BG002|Baseline|Total|Total of all reporting groups
10975528|NCT00936221|FG000|Participant Flow|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
10975529|NCT00936221|FG001|Participant Flow|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
10975530|NCT00936221|OG000|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
10975531|NCT00936221|OG001|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
10975532|NCT00936221|EG000|Reported Event|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
11098319|NCT01575769|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
11098320|NCT01575769|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) via intravenous (IV) infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
11098321|NCT01575769|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
11098322|NCT01575769|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
11098323|NCT01575769|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
11098324|NCT01575769|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
11098325|NCT01575808|BG000|Baseline|GP1101|Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
11098326|NCT01575808|BG001|Baseline|Retrospective Surgical Bypass Outcomes|Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
11098327|NCT01575808|BG002|Baseline|Total|Total of all reporting groups
11098328|NCT01575808|FG000|Participant Flow|GP1101|"Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular Device Implantation"
11098329|NCT01575808|FG001|Participant Flow|Retrospective Surgical Bypass Outcomes|Retrospective data collection (Apr 2012 - Apr 2014) surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
11098330|NCT01575808|OG000|Outcome|GP1101|"Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
11098331|NCT01575808|OG000|Outcome|GP1101|Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
11098332|NCT01575808|OG001|Outcome|Retrospective Surgical Bypass Outcomes|Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
10975533|NCT00936221|EG001|Reported Event|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
11098333|NCT01575808|OG000|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
11098334|NCT01575808|OG000|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft>~> GP1101: Endovascular stent graft implantation"
10975534|NCT00936299|BG000|Baseline|Bupropion + Cognitive Behavioral Therapy|Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
10975535|NCT00936299|BG001|Baseline|Placebo + Cognitive Behavioral Therapy|Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
10975536|NCT00936299|BG002|Baseline|Total|Total of all reporting groups
10975537|NCT00936299|FG000|Participant Flow|Bupropion + Cognitive Behavioral Therapy|Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
10975538|NCT00936299|FG001|Participant Flow|Placebo + Cognitive Behavioral Therapy|Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
10975539|NCT00936299|OG000|Outcome|Bupropion + Cognitive Behavioral Therapy|Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
10975540|NCT00936299|OG001|Outcome|Placebo + Cognitive Behavioral Therapy|Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
10975541|NCT00936299|OG000|Outcome|Bupropion + Cognitive Behavioral Therapy|"Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.~Bupropion: Bupropion (target dose 300 mg/day) + cognitive behavioral therapy; matched placebo + cognitive behavioral therapy"
10975542|NCT00936299|OG001|Outcome|Placebo + Cognitive Behavioral Therapy|"Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.~Placebo"
10975543|NCT00936299|EG000|Reported Event|Bupropion + Cognitive Behavioral Therapy|Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
10975544|NCT00936299|EG001|Reported Event|Placebo + Cognitive Behavioral Therapy|Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
10975545|NCT00936351|BG000|Baseline|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention has been adapted from mindfulness based stress reduction treatment."
10975546|NCT00936351|BG001|Baseline|Arm 2|"Support Group~Support Group (control): A support group during which participants can discuss with each other any issues, problems, or successes at work will be conducted as the control portion."
10975547|NCT00936351|BG002|Baseline|Total|Total of all reporting groups
10975548|NCT00936351|FG000|Participant Flow|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
10975549|NCT00936351|FG001|Participant Flow|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
10975550|NCT00936351|OG000|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
10975551|NCT00936351|OG001|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
10975552|NCT00936351|EG000|Reported Event|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
10975553|NCT00936351|EG001|Reported Event|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
10975554|NCT00936377|BG000|Baseline|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
10975555|NCT00936377|BG001|Baseline|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
10975556|NCT00936377|BG002|Baseline|Placebo|"Normal saline~Placebo: Normal saline for five days."
10975557|NCT00936377|BG003|Baseline|Total|Total of all reporting groups
10975558|NCT00936377|FG000|Participant Flow|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
10975559|NCT00936377|FG001|Participant Flow|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
10975560|NCT00936377|FG002|Participant Flow|Placebo|"Normal saline~Placebo: Normal saline for five days."
10975561|NCT00936377|OG000|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
10975562|NCT00936377|OG001|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
10975563|NCT00936377|OG002|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
10975564|NCT00936377|EG000|Reported Event|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
10975565|NCT00936377|EG001|Reported Event|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
10975566|NCT00936377|EG002|Reported Event|Placebo|"Normal saline~Placebo: Normal saline for five days."
10975567|NCT00936455|BG000|Baseline|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
10975568|NCT00936455|BG001|Baseline|Telephone|Telephone evaluated patients
10975569|NCT00936455|BG002|Baseline|Total|Total of all reporting groups
10975570|NCT00936455|FG000|Participant Flow|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
10975571|NCT00936455|FG001|Participant Flow|Telephone|Telephone evaluated patients
10975572|NCT00936455|OG000|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group
10975573|NCT00936455|OG001|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
10975574|NCT00936455|OG000|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)
10975575|NCT00936455|OG001|Outcome|Telephone|Recurrent stroke at 6 months in each group
10975576|NCT00936455|OG000|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)
10975577|NCT00936455|OG001|Outcome|Telephone|Assessing number of recurrent strokes by 12 months
10975578|NCT00936455|OG000|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 12 months after index event in telemedicine group
10975579|NCT00936455|OG001|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 12 months after index event in telephone group
10975580|NCT00936455|EG000|Reported Event|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
10975581|NCT00936455|EG001|Reported Event|Telephone|Telephone evaluated patients
10975582|NCT00936481|BG000|Baseline|Healthy Controls|18 years or older with body mass index between 25-45
10975583|NCT00936481|BG001|Baseline|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
10975584|NCT00936481|BG002|Baseline|Total|Total of all reporting groups
10975585|NCT00936481|FG000|Participant Flow|Healthy Controls|18 years or older with body mass index between 25-45
10975586|NCT00936481|FG001|Participant Flow|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
10975587|NCT00936481|OG000|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
10975588|NCT00936481|OG001|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
10975589|NCT00936481|EG000|Reported Event|Healthy Controls|18 years or older with body mass index between 25-45
10975590|NCT00936481|EG001|Reported Event|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
10975591|NCT00936611|BG000|Baseline|LBH589|"30 mg three days a week (Mondays, Wednesdays and Fridays).~1 cycle was 28 days~Dose modifications for attributable toxicities allowed for reduction to:~25 mg, 20 mg three times a week every week~Or 20 mg three times a week every other week. No dose re-escalation was allowed.~The protocol was amended on 6/15/2010 because of concerns of toxicity to allow a starting dose of 25 mg; 12/36 (33%) patients were enrolled on the 25 mg dose.~LBH589"
10975592|NCT00936611|FG000|Participant Flow|LBH589|"30 mg three days a week (Mondays, Wednesdays and Fridays).~1 cycle was 28 days~Dose modifications for attributable toxicities allowed for reduction to:~25 mg, 20 mg three times a week every week~Or 20 mg three times a week every other week. No dose re-escalation was allowed.~The protocol was amended on 6/15/2010 because of concerns of toxicity to allow a starting dose of 25 mg; 12/36 (33%) patients were enrolled on the 25 mg dose.~LBH589"
10975593|NCT00936611|OG000|Outcome|LBH589|"30 mg three days a week (Mondays, Wednesdays and Fridays).~1 cycle was 28 days~Dose modifications for attributable toxicities allowed for reduction to:~25 mg, 20 mg three times a week every week~Or 20 mg three times a week every other week. No dose re-escalation was allowed.~The protocol was amended on 6/15/2010 because of concerns of toxicity to allow a starting dose of 25 mg; 12/36 (33%) patients were enrolled on the 25 mg dose.~LBH589"
10975594|NCT00936611|EG000|Reported Event|LBH589|"30 mg three days a week (Mondays, Wednesdays and Fridays).~1 cycle was 28 days~Dose modifications for attributable toxicities allowed for reduction to:~25 mg, 20 mg three times a week every week~Or 20 mg three times a week every other week. No dose re-escalation was allowed.~The protocol was amended on 6/15/2010 because of concerns of toxicity to allow a starting dose of 25 mg; 12/36 (33%) patients were enrolled on the 25 mg dose.~LBH589"
10975595|NCT00936663|BG000|Baseline|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
10975596|NCT00936663|BG001|Baseline|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
10975597|NCT00936663|BG002|Baseline|Total|Total of all reporting groups
11007008|NCT01089023|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions.
10975598|NCT00936663|FG000|Participant Flow|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
10975599|NCT00936663|FG001|Participant Flow|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
10975600|NCT00936663|OG000|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
10975601|NCT00936663|OG001|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
10975602|NCT00936663|EG000|Reported Event|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
10975603|NCT00936663|EG001|Reported Event|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
10975604|NCT00936702|BG000|Baseline|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
10975605|NCT00936702|FG000|Participant Flow|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
10975606|NCT00936702|OG000|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
10975607|NCT00936702|EG000|Reported Event|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
10975608|NCT00936715|BG000|Baseline|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
10975609|NCT00936715|FG000|Participant Flow|FTC/TDF|Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, Truvada®) (200/300 mg) fixed dose combination (FDC) tablet administered once daily for up to 240 weeks.
10975610|NCT00936715|OG000|Outcome|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
10975611|NCT00936715|EG000|Reported Event|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered orally once daily for up to 240 weeks
10975612|NCT00936741|BG000|Baseline|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
10975613|NCT00936741|FG000|Participant Flow|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
10975614|NCT00936741|OG000|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
10975615|NCT00936741|EG000|Reported Event|Mifepristone 300 to 1200 mg Daily|mifepristone at doses from 300 mg/day to 1200 mg/day
10975616|NCT00936858|BG000|Baseline|Arm A|"RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once a day in the morning"
10975617|NCT00936858|FG000|Participant Flow|RAD001 Group|"RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once a day in the morning"
10975618|NCT00936858|OG000|Outcome|Arm A|"RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once a day in the morning"
11098335|NCT01575808|EG000|Reported Event|GP1101|Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
11098336|NCT01575834|BG000|Baseline|Placebo/Denosumab|Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
11098337|NCT01575834|BG001|Baseline|Romosozumab/Denosumab|Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
11098338|NCT01575834|BG002|Baseline|Total|Total of all reporting groups
11098339|NCT01575834|FG000|Participant Flow|Placebo/Denosumab|Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
11098340|NCT01575834|FG001|Participant Flow|Romosozumab/Denosumab|Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
11098341|NCT01575834|OG000|Outcome|Placebo|Participants received placebo subcutaneous injections once a month for 12 months.
11098342|NCT01575834|OG001|Outcome|Romosozumab|Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
11098343|NCT01575834|OG000|Outcome|Placebo/Denosumab|Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
10975619|NCT00936858|OG000|Outcome|Arm A|"RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001"
10975620|NCT00936858|EG000|Reported Event|Arm A|"RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once a day in the morning"
10975621|NCT00936884|BG000|Baseline|Methylnaltrexone Double-blind|"Methylnaltrexone once every other day.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg."
10975622|NCT00936884|BG001|Baseline|Placebo|"Placebo once every other day.~Subjects received matching placebo injections."
10975623|NCT00936884|BG002|Baseline|Total|Total of all reporting groups
10975624|NCT00936884|FG000|Participant Flow|Methylnaltrexone Double-blind|Methylnaltrexone once every other day.
10975625|NCT00936884|FG001|Participant Flow|Placebo|Placebo once every other day.
10975626|NCT00936884|FG002|Participant Flow|Methylnaltrexone Open-label|Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period.
10975627|NCT00936884|OG000|Outcome|Methylnaltrexone Double-blind|"Methylnaltrexone once every other day.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg."
10975628|NCT00936884|OG001|Outcome|Placebo|"Placebo once every other day.~Subjects received matching placebo injections."
10975629|NCT00936884|EG000|Reported Event|Methylnaltrexone Double-blind|"Methylnaltrexone once every other day.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg."
10975630|NCT00936884|EG001|Reported Event|Placebo|"Placebo once every other day.~Subjects received matching placebo injections."
10975631|NCT00936884|EG002|Reported Event|Methylnaltrexone Open-label|Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period.
10975632|NCT00936897|BG000|Baseline|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
10975633|NCT00936897|BG001|Baseline|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
10975634|NCT00936897|BG002|Baseline|Total|Total of all reporting groups
10975635|NCT00936897|FG000|Participant Flow|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
10975636|NCT00936897|FG001|Participant Flow|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
11098344|NCT01575834|OG001|Outcome|Romosozumab/Denosumab|Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
10975637|NCT00936897|OG000|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
10975638|NCT00936897|OG001|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
10975639|NCT00936897|EG000|Reported Event|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
10975640|NCT00936897|EG001|Reported Event|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
10975641|NCT00936910|BG000|Baseline|Treated Patients|Patients enrolled had intestinal insufficiency (including intestinal transplantation) and/or the presence of long term central venous access, and one or more positive cultures for yeast attributed to the central line. Patients were excluded if they hypotension at the time of enrollment or need for ICU support.
10975642|NCT00936910|FG000|Participant Flow|Antifungal Lock-treated Patients|"This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections~After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
10975643|NCT00936910|OG000|Outcome|Antifungal Lock-treated Patients|"This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections~After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
10975644|NCT00936910|OG000|Outcome|Antifungal Lock-treated Patients|"Intestinal failure and other patients with poor IV access and central line fungal-related infections~After enrollment, antifungal therapy will be instituted consisting of both IV systemic and antifungal lock therapy. Systemic therapy will be Ambisome administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing up to 2.3 ml of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
10975645|NCT00936910|EG000|Reported Event|Antifungal Lock-treated Patients|"Intestinal failure and other patients with poor IV access and central line fungal-related infections~After enrollment, antifungal therapy will be instituted consisting of both IV systemic and antifungal lock therapy. Systemic therapy will be Ambisome administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing up to 2.3 ml (maximum catheter size) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
10975646|NCT00936975|BG000|Baseline|Overall|Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline
11098345|NCT01575834|EG000|Reported Event|12-Month Double-blind Period: Placebo|Participants received placebo subcutaneous injections once a month for 12 months
10975647|NCT00936975|FG000|Participant Flow|Overall|"Participants on the parent study (Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer) receiving 100mg PO QD Dasatinib"
10975648|NCT00936975|OG000|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
10975649|NCT00936975|OG000|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
10975650|NCT00936975|EG000|Reported Event|Overall|Participants receiving 100mg PO QD Dasatinib
10975651|NCT00937040|BG000|Baseline|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
10975652|NCT00937040|BG001|Baseline|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
10975653|NCT00937040|BG002|Baseline|Total|Total of all reporting groups
10975654|NCT00937040|FG000|Participant Flow|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
10975655|NCT00937040|FG001|Participant Flow|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
10975656|NCT00937040|OG000|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
10975657|NCT00937040|OG001|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
10975658|NCT00937040|EG000|Reported Event|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
10975659|NCT00937040|EG001|Reported Event|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
10975660|NCT00937105|BG000|Baseline|Lotrafilcon A and Renu|
10975661|NCT00937105|BG001|Baseline|Lotrafilcon A and Clear Care|
10975662|NCT00937105|BG002|Baseline|Total|Total of all reporting groups
10975663|NCT00937105|FG000|Participant Flow|Lotrafilcon A Lenses and Clear Care|
10975664|NCT00937105|FG001|Participant Flow|Lotrafilcon A Lenses and Renu Multiplus|
10975665|NCT00937105|OG000|Outcome|Lotrafilcon A Lenses and Renu|
10975666|NCT00937105|OG001|Outcome|Lotrafilcon A Lenses and Clear Care|
10975667|NCT00937105|OG000|Outcome|Participants With Microbial Bioburden on Lenses|
10975668|NCT00937105|OG001|Outcome|Participants Without Microbial Bioburden on Lenses|
10975669|NCT00937105|OG000|Outcome|Participants With Corneal Staining|
10975670|NCT00937105|OG001|Outcome|Participants Without Corneal Staining|
10975671|NCT00937105|OG000|Outcome|Participants With Microbial Bioburden on Lens Cases|
11098346|NCT01575834|EG001|Reported Event|12-Month Double-blind Period: Romosozumab|Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
11098347|NCT01575834|EG002|Reported Event|36-Month Study Period: Placebo/Denosumab|Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
10975672|NCT00937105|OG001|Outcome|Participants With no Microbial Bioburden on Lens Cases|
10975673|NCT00937105|OG000|Outcome|Participants With Microbial Bioburden on Lid Margins|
10975674|NCT00937105|OG001|Outcome|Participants With no Microbial Bioburden on Lid Margins|
10975675|NCT00937105|OG000|Outcome|Participants With CNS Bioburden on Lid Margins|
10975676|NCT00937105|OG001|Outcome|Participants With no CNS Bioburden on Lid Margins|
10975677|NCT00937105|EG000|Reported Event|Entire Cohort of Lotrafilcon A Users|
10975678|NCT00937118|BG000|Baseline|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
10975679|NCT00937118|FG000|Participant Flow|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
10975680|NCT00937118|OG000|Outcome|No Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did not have diversion, decompression, or exclusion techniques
10975681|NCT00937118|OG001|Outcome|Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did have diversion, decompression, or exclusion techniques
10975682|NCT00937118|OG002|Outcome|Damage Control|Patients with full thickness duodenal laceration undergoing laparotomy who had a damage control technique
10975683|NCT00937118|OG003|Outcome|Fascial Closure|Patients with full thickness duodenal laceration undergoing laparotomy who did not have damage control and instead had primary fascial closure
10975684|NCT00937118|EG000|Reported Event|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
10975685|NCT00937157|BG000|Baseline|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
11007009|NCT01089062|BG000|Baseline|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
11007010|NCT01089062|BG001|Baseline|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
10975686|NCT00937157|FG000|Participant Flow|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.~Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
10975687|NCT00937157|OG000|Outcome|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
10975688|NCT00937157|EG000|Reported Event|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.~Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
10975689|NCT00937235|BG000|Baseline|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
10975690|NCT00937235|BG001|Baseline|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
10975691|NCT00937235|BG002|Baseline|Total|Total of all reporting groups
10975692|NCT00937235|FG000|Participant Flow|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
10975693|NCT00937235|FG001|Participant Flow|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
10975694|NCT00937235|OG000|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
10975695|NCT00937235|OG001|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
10975696|NCT00937235|EG000|Reported Event|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
10975697|NCT00937235|EG001|Reported Event|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
10975698|NCT00937326|BG000|Baseline|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975699|NCT00937326|BG001|Baseline|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975700|NCT00937326|BG002|Baseline|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975701|NCT00937326|BG003|Baseline|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975702|NCT00937326|BG004|Baseline|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975703|NCT00937326|BG005|Baseline|Total|Total of all reporting groups
10975704|NCT00937326|FG000|Participant Flow|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 minutes (min) following the start of meal consumption with 1 to 2 glasses of water.
11098348|NCT01575834|EG003|Reported Event|36-Month Study Period: Romosozumab/Denosumab|Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
11098349|NCT01575873|BG000|Baseline|Risedronate: Glucocorticoid-initiating|Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
11098350|NCT01575873|BG001|Baseline|Denosumab: Glucocorticoid-initiating|Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
11098351|NCT01575873|BG002|Baseline|Risedronate: Glucocorticoid-continuing|Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
11098352|NCT01575873|BG003|Baseline|Denosumab: Glucocorticoid-continuing|Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
11098353|NCT01575873|BG004|Baseline|Total|Total of all reporting groups
11098354|NCT01575873|FG000|Participant Flow|Risedronate: Glucocorticoid-initiating|Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
11098355|NCT01575873|FG001|Participant Flow|Denosumab: Glucocorticoid-initiating|Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
11098356|NCT01575873|FG002|Participant Flow|Risedronate: Glucocorticoid-continuing|Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
11098357|NCT01575873|FG003|Participant Flow|Denosumab: Glucocorticoid-continuing|Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
11098358|NCT01575873|OG000|Outcome|Risedronate: Glucocorticoid-initiating|Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
11098359|NCT01575873|OG001|Outcome|Denosumab: Glucocorticoid-initiating|Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
11098360|NCT01575873|OG002|Outcome|Risedronate: Glucocorticoid-continuing|Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
11098361|NCT01575873|OG003|Outcome|Denosumab: Glucocorticoid-continuing|Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
11098362|NCT01575873|EG000|Reported Event|Risedronate|Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
11098363|NCT01575873|EG001|Reported Event|Denosumab|Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
11098364|NCT01575899|BG000|Baseline|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
11220598|NCT02335125|OG000|Outcome|Intervention|"The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Psychotropic Drugs~Care Management"
11098365|NCT01575899|BG001|Baseline|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
11098366|NCT01575899|BG002|Baseline|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
11098367|NCT01575899|BG003|Baseline|Total|Total of all reporting groups
11098368|NCT01575899|FG000|Participant Flow|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
11098369|NCT01575899|FG001|Participant Flow|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
11098370|NCT01575899|FG002|Participant Flow|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
11098371|NCT01575899|OG000|Outcome|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
11098372|NCT01575899|OG001|Outcome|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
11098373|NCT01575899|OG000|Outcome|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
11098374|NCT01575899|OG000|Outcome|Levofloxacin-Amox/Clav.|Participants who are living in rural area and received 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for Hp eradication.
11098375|NCT01575899|OG001|Outcome|Clarithromycin-Amoxicillin|Participants who are living in rural area and received 7-day clarithromycin, amoxicillin and rabeprazole for Hp eradication.
11098376|NCT01575899|EG000|Reported Event|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
11098377|NCT01575899|EG001|Reported Event|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
11098378|NCT01575899|EG002|Reported Event|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
11098379|NCT01575912|BG000|Baseline|Group of Subjects With Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
11098380|NCT01575912|BG001|Baseline|Group of Subjects Presenting Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
11220599|NCT02335125|OG001|Outcome|Usual Care|Only standard care practices will be administered to this arm.
10975705|NCT00937326|FG001|Participant Flow|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975706|NCT00937326|FG002|Participant Flow|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975707|NCT00937326|FG003|Participant Flow|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975708|NCT00937326|FG004|Participant Flow|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975709|NCT00937326|OG000|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975710|NCT00937326|OG001|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975711|NCT00937326|OG002|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975712|NCT00937326|OG003|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975713|NCT00937326|OG004|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975714|NCT00937326|OG000|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975715|NCT00937326|OG001|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975716|NCT00937326|OG002|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975717|NCT00937326|OG003|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
11098381|NCT01575912|BG002|Baseline|Group of Controls Without Psychiatric Disorder|subjects without any psychiatric disorder and submitted to experimental pain tests
11098382|NCT01575912|BG003|Baseline|Total|Total of all reporting groups
11098383|NCT01575912|FG000|Participant Flow|Group of Subjects Presenting Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
11098384|NCT01575912|FG001|Participant Flow|Group of Subjects Presenting Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
11098385|NCT01575912|FG002|Participant Flow|Group of Subjects Without Psychiatric Troubles C|subjects without any psychiatric disorder and submitted to experimental pain tests
11098386|NCT01575912|OG000|Outcome|Group of Subjects Presenting Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
11098387|NCT01575912|OG001|Outcome|Group of Subjects With Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
11098388|NCT01575912|OG002|Outcome|Group of Subjects Without Psychiatric Troubles C|control subjects without any psychiatric disorder
10975718|NCT00937326|OG000|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 minutes following the start of meal consumption with 1 to 2 glasses of water.
10975719|NCT00937326|EG000|Reported Event|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975720|NCT00937326|EG001|Reported Event|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
11098389|NCT01575912|EG000|Reported Event|Group of Subjects With Schizophrenia SC|subjects presenting a diagnosis of schizophrenia according to the DSM IV TR and submitted to experimental pain tests
11098390|NCT01575912|EG001|Reported Event|Group of Subjects Presenting Major Depression MD|subjects presenting a diagnosis of major depression according to the DSM IV TR and submitted to experimental pain tests
11098391|NCT01575912|EG002|Reported Event|Group of Controls Without Psychiatric Disorder|control subjects without any psychiatric disorder and submitted to experimental pain tests
11098392|NCT01576003|BG000|Baseline|Glutamine|L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
11098393|NCT01576003|BG001|Baseline|Placebo|L-Alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
11098394|NCT01576003|BG002|Baseline|Healthy Control|No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.
11098395|NCT01576003|BG003|Baseline|Total|Total of all reporting groups
11098396|NCT01576003|FG000|Participant Flow|Glutamine|L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
11098397|NCT01576003|FG001|Participant Flow|Placebo|L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
11098398|NCT01576003|FG002|Participant Flow|Healthy Control|No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.
11098399|NCT01576003|OG000|Outcome|Glutamine|Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
11098400|NCT01576003|OG001|Outcome|Placebo|L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
11098401|NCT01576003|OG000|Outcome|Glutamine|L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
11098402|NCT01576003|EG000|Reported Event|Glutamine|L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
11098403|NCT01576003|EG001|Reported Event|Placebo|L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
11098404|NCT01576003|EG002|Reported Event|Healthy Control|No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.
11098405|NCT01576016|BG000|Baseline|Lead Safety Phase|Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
11098406|NCT01576016|BG001|Baseline|MRI Phase|A subset of patients enrolled in the Lead safety phase (225 subjects from lead safety phase) underwent an elective MRI scan to evaluate the safety and efficacy of Accent MRI system within the MRI environment.
11098407|NCT01576016|BG002|Baseline|Total|Total of all reporting groups
11098408|NCT01576016|FG000|Participant Flow|Lead Safety Phase|Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
11098409|NCT01576016|FG001|Participant Flow|MRI Safety Phase|A subset of patients enrolled in the Lead safety phase underwent an elective MRI scan to evaluate the safety and efficacy of Accent MRI system within the MRI environment.
11098410|NCT01576016|OG000|Outcome|Lead Safety Phase|Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
11098411|NCT01576016|OG000|Outcome|MRI Safety Phase|Evaluate the safety and efficacy of the St. Jude Medical Brady MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker, within the MRI environment.
11098412|NCT01576016|OG000|Outcome|MRI Efficacy Phase|Evaluate the efficacy of the St. Jude Medical Brady MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker, within the MRI environment.
11098413|NCT01576016|OG000|Outcome|MRI Efficacy Phase|Evaluate the efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker, within the MRI environment.
11098414|NCT01576016|EG000|Reported Event|Lead Safety Phase|Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
11098415|NCT01576016|EG001|Reported Event|MRI Phase|Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker, within the MRI environment.
11098416|NCT01576042|BG000|Baseline|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
11098417|NCT01576042|BG001|Baseline|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
11098418|NCT01576042|BG002|Baseline|Total|Total of all reporting groups
11098419|NCT01576042|FG000|Participant Flow|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
11098420|NCT01576042|FG001|Participant Flow|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
11098421|NCT01576042|OG000|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
11098422|NCT01576042|OG001|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
11098423|NCT01576042|EG000|Reported Event|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
11098424|NCT01576042|EG001|Reported Event|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
11098425|NCT01576055|BG000|Baseline|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
11098426|NCT01576055|BG001|Baseline|BARD LifeStent|BARD LifeStent: Implant
11098427|NCT01576055|BG002|Baseline|Total|Total of all reporting groups
11098428|NCT01576055|FG000|Participant Flow|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
11098429|NCT01576055|FG001|Participant Flow|BARD LifeStent|BARD LifeStent: Implant
11098430|NCT01576055|OG000|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
11098431|NCT01576055|OG001|Outcome|BARD LifeStent|BARD LifeStent: Implant
11098432|NCT01576055|EG000|Reported Event|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
11098433|NCT01576055|EG001|Reported Event|BARD LifeStent|BARD LifeStent: Implant
11343051|NCT03722524|OG000|Outcome|Patients With Arterial Hypertension|"The patient is included in the program if prior to the study his/her doctor decided to adjust treatment, targeted at the BP control improvement, by prescription of a triple FDC of amlodipine / indapamide / perindopril arginine. The prescription of the triple FDC of amlodipine / indapamide / perindopril arginine during the program is made by the doctor's decision according to the instructions for medical use of this FDC.~Presumably, each doctor will include 4 patients in average. It is planned to include 1,300 patients.~amlodipine / indapamide / perindopril arginine FDC: CCB / diuretic / ACE inhibitor"
11098434|NCT01576120|BG000|Baseline|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
11098435|NCT01576120|BG001|Baseline|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
11098436|NCT01576120|BG002|Baseline|Total|Total of all reporting groups
11098437|NCT01576120|FG000|Participant Flow|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
11098438|NCT01576120|FG001|Participant Flow|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
11098439|NCT01576120|OG000|Outcome|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
11098440|NCT01576120|OG001|Outcome|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
11098441|NCT01576120|EG000|Reported Event|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
11098442|NCT01576120|EG001|Reported Event|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
11098443|NCT01576146|BG000|Baseline|Etelcalcetide|Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
11098444|NCT01576146|FG000|Participant Flow|Etelcalcetide|Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
11098445|NCT01576146|OG000|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
11098446|NCT01576146|EG000|Reported Event|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
11098447|NCT01576159|BG000|Baseline|High-Impact Loading|Performed high-impact running exercise during intervention period.
11098448|NCT01576159|BG001|Baseline|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
11098449|NCT01576159|BG002|Baseline|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
11098450|NCT01576159|BG003|Baseline|Control Group|Didn't participate any organized physical exercises
11098451|NCT01576159|BG004|Baseline|Total|Total of all reporting groups
11098452|NCT01576159|FG000|Participant Flow|High-Impact Loading|Performed high-impact running exercise during intervention period.
11098453|NCT01576159|FG001|Participant Flow|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
11098454|NCT01576159|FG002|Participant Flow|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
11098455|NCT01576159|FG003|Participant Flow|Control Group|Didn't participate any organized physical exercises
11098456|NCT01576159|OG000|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
11098457|NCT01576159|OG001|Outcome|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
11098458|NCT01576159|OG002|Outcome|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
11098459|NCT01576159|OG003|Outcome|Control Group|Didn't participate any organized physical exercises
11098460|NCT01576159|OG001|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise during intervention period.
11098461|NCT01576159|OG002|Outcome|Non-Impact Loading|Performed non-impact swimming exercise during intervention period.
11098462|NCT01576159|OG003|Outcome|Control Group|Not participated any organized physical exercise
11098463|NCT01576159|OG000|Outcome|High-Impact Loading|Performed high-impact running exercise for 12 weeks
11098464|NCT01576159|OG001|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise for 12 weeks
11098465|NCT01576159|OG002|Outcome|Non-Impact Loading|Performed Non-impact swimming exercise for 12 weeks
11098466|NCT01576159|OG003|Outcome|Control Group|Not Participated any organized physical exercise
11098467|NCT01576159|EG000|Reported Event|High-Impact Loading|Performed high-impact running exercise during intervention period.
11098468|NCT01576159|EG001|Reported Event|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
11098469|NCT01576159|EG002|Reported Event|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
11098470|NCT01576159|EG003|Reported Event|Control Group|Didn't participate any organized physical exercises
11098471|NCT01576172|BG000|Baseline|Arm I (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Prednisone: Given PO"
11098472|NCT01576172|BG001|Baseline|Arm II (Abiraterone Acetate, Prednisone, and Veliparib)|"Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Prednisone: Given PO~Veliparib: Given PO"
11098473|NCT01576172|BG002|Baseline|Total|Total of all reporting groups
11098474|NCT01576172|FG000|Participant Flow|Arm I (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Prednisone: Given PO"
11098475|NCT01576172|FG001|Participant Flow|Arm II (Abiraterone Acetate, Prednisone, and Veliparib)|"Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Prednisone: Given PO~Veliparib: Given PO"
11098476|NCT01576172|OG000|Outcome|Arm I (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Prednisone: Given PO"
11098477|NCT01576172|OG001|Outcome|Arm II (Abiraterone Acetate, Prednisone, and Veliparib)|"Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Prednisone: Given PO~Veliparib: Given PO"
11098478|NCT01576172|OG000|Outcome|Arm I (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Prednisone: Given PO"
11098479|NCT01576172|OG001|Outcome|Arm II (Abiraterone Acetate, Prednisone, and Veliparib)|"Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Prednisone: Given PO~Veliparib: Given PO"
11098480|NCT01576172|EG000|Reported Event|Arm I (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Prednisone: Given PO"
11098481|NCT01576172|EG001|Reported Event|Arm II (Abiraterone Acetate, Prednisone, and Veliparib)|"Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Prednisone: Given PO~Veliparib: Given PO"
11098482|NCT01576276|BG000|Baseline|Morphine Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Morphine: 3 administrations of morphine over course of study"
11098483|NCT01576276|BG001|Baseline|Ketorolac Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Ketorolac: 3 administrations of ketorolac over course of study"
11098484|NCT01576276|BG002|Baseline|Total|Total of all reporting groups
11098485|NCT01576276|FG000|Participant Flow|Morphine Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Morphine: 3 administrations of morphine over course of study"
11098486|NCT01576276|FG001|Participant Flow|Ketorolac Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Ketorolac: 3 administrations of ketorolac over course of study"
11098487|NCT01576276|OG000|Outcome|fMRI Signal Change|We used SPM 12 to analyze the data, and compared the fMRI signal change during pressure pain between 1. morphine injection cue vs. control cue, 2. ketorolac injection cue vs. control cue. A threshold of p < 0.005 with 10 continuous voxels was applied.
11098488|NCT01576276|OG000|Outcome|Morphine Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Morphine: 3 administrations of morphine over course of study"
11098489|NCT01576276|OG001|Outcome|Ketorolac Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Ketorolac: 3 administrations of ketorolac over course of study"
11098490|NCT01576276|EG000|Reported Event|Morphine Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Morphine: 3 administrations of morphine over course of study"
11098491|NCT01576276|EG001|Reported Event|Ketorolac Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Ketorolac: 3 administrations of ketorolac over course of study"
11098492|NCT01576341|BG000|Baseline|HX575, Safety Population|The Study was designed as single arm study with HX575 tested as investigational medicinal product. The safety population (SAF) consisted of all patients that received at least one dose of study drug. 417 patients enrolled, 416 treated. Group includes ESA-naïve patients and patients on ESA-maintenance therapy.
11098493|NCT01576341|FG000|Participant Flow|HX575, Safety Population|In the single arm study, HX575 was tested as investigational medicinal product. The single arm includes ESA-naïve patients and patients on ESA-maintenance therapy.
11098494|NCT01576341|OG000|Outcome|HX575|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL
11126238|NCT02478775|EG002|Reported Event|Experimental: Frequent Blood Sampling, Cetrorelix: Obese|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.~Obese participants = BMI of >30"
11098495|NCT01576341|OG000|Outcome|HX575 - ESA Naive|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL. At study start patients were either ESA (Erythropoiesis Stimulating Agent) naive or on ESA maintenance treatment. This group only contains patients that were ESA naive at study start, e.g. did not receive any ESA dose within 2 months prior to first screening visit.
11098496|NCT01576341|OG001|Outcome|HX575 - ESA Maintenance|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL. At study start patients were either ESA (Erythropoiesis Stimulating Agent) naive or on ESA maintenance treatment. This group only contains patients that were on ESA maintenance treatment at study start, e.g. did receive at least one dose of commercial ESA treatment within 2 months prior to first screening visit.
11098497|NCT01576341|OG002|Outcome|HX575|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL.
11098498|NCT01576341|EG000|Reported Event|HX575, Safety Population|Study was designed as single arm study with HX575 tested as investigational medicinal product. Safety population includes ESA therapy naïve patients and ESA maintenance patients. Shown are all AEs including non-treatment related AEs.
11098499|NCT01576367|BG000|Baseline|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
11098500|NCT01576367|FG000|Participant Flow|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
11098501|NCT01576367|OG000|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
11098502|NCT01576367|EG000|Reported Event|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
11098503|NCT01576406|BG000|Baseline|Normal Hepatic Function: Crizotinib 250 mg Twice Daily|Participants with normal hepatic function received Crizotinib 250 milligram (mg) capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and aspartate aminotransferase (AST) levels less than or equal to (<=) the upper limit of normal (ULN).
11098504|NCT01576406|BG001|Baseline|Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily|Participants with normal hepatic function received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles and dose could be increased to 250 mg twice daily after completion of pharmacokinetic (PK) assessment on Cycle 2 Day 1 based on their tolerability. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and AST levels <=ULN.
11098505|NCT01576406|BG002|Baseline|Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily|Participants with mild hepatic impairment received Crizotinib 250 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Mild hepatic impairment was defined as total bilirubin level <=ULN and AST levels greater than (>) ULN or total bilirubin level > 1.0 to 1.5*ULN.
11098506|NCT01576406|BG003|Baseline|Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily|Participants with moderate hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level >1.5 to 3*ULN
11098507|NCT01576406|BG004|Baseline|Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily|Participants with moderate hepatic impairment received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level >1.5 to 3*ULN
11098508|NCT01576406|BG005|Baseline|Severe Hepatic Impairment Crizotinib 250 mg Once Daily|Participants with severe hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Severe hepatic Impairment was defined as total bilirubin level >3*ULN.
11098509|NCT01576406|BG006|Baseline|Total|Total of all reporting groups
11098510|NCT01576406|FG000|Participant Flow|Normal Hepatic Function: Crizotinib 250 mg Twice Daily|Participants with normal hepatic function received Crizotinib 250 milligram (mg) capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and aspartate aminotransferase (AST) levels less than or equal to (<=) the upper limit of normal (ULN).
11098511|NCT01576406|FG001|Participant Flow|Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily|Participants with normal hepatic function received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles and dose could be increased to 250 mg twice daily after completion of pharmacokinetic (PK) assessment on Cycle 2 Day 1 based on their tolerability. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and AST levels <=ULN.
11098512|NCT01576406|FG002|Participant Flow|Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily|Participants with mild hepatic impairment received Crizotinib 250 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Mild hepatic impairment was defined as total bilirubin level <=ULN and AST levels greater than (>) ULN or total bilirubin level > 1.0 to 1.5*ULN.
11098513|NCT01576406|FG003|Participant Flow|Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily|Participants with moderate hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level >1.5 to 3*ULN
11098514|NCT01576406|FG004|Participant Flow|Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily|Participants with moderate hepatic impairment received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level >1.5 to 3*ULN
11098515|NCT01576406|FG005|Participant Flow|Severe Hepatic Impairment Crizotinib 250 mg Once Daily|Participants with severe hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Severe hepatic Impairment was defined as total bilirubin level >3*ULN.
11098516|NCT01576406|OG000|Outcome|Normal Hepatic Function: Crizotinib 250 mg Twice Daily|Participants with normal hepatic function received Crizotinib 250 milligram (mg) capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and aspartate aminotransferase (AST) levels less than or equal to (<=) the upper limit of normal (ULN).
11098517|NCT01576406|OG001|Outcome|Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily|Participants with normal hepatic function received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles and dose could be increased to 250 mg twice daily after completion of pharmacokinetic (PK) assessment on Cycle 2 Day 1 based on their tolerability. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and AST levels <=ULN.
11098518|NCT01576406|OG002|Outcome|Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily|Participants with mild hepatic impairment received Crizotinib 250 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Mild hepatic impairment was defined as total bilirubin level <=ULN and AST levels greater than (>) ULN or total bilirubin level > 1.0 to 1.5*ULN.
11098519|NCT01576406|OG003|Outcome|Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily|Participants with moderate hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level >1.5 to 3*ULN
11098520|NCT01576406|OG004|Outcome|Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily|Participants with moderate hepatic impairment received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level >1.5 to 3*ULN
11098521|NCT01576406|OG005|Outcome|Severe Hepatic Impairment Crizotinib 250 mg Once Daily|Participants with severe hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Severe hepatic Impairment was defined as total bilirubin level >3*ULN.
11098522|NCT01576406|EG000|Reported Event|Normal Hepatic Function: Crizotinib 250 mg Twice Daily|Participants with normal hepatic function received Crizotinib 250 milligram (mg) capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and aspartate aminotransferase (AST) levels less than or equal to (<=) the upper limit of normal (ULN).
11098523|NCT01576406|EG001|Reported Event|Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily|Participants with normal hepatic function received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles and dose could be increased to 250 mg twice daily after completion of pharmacokinetic (PK) assessment on Cycle 2 Day 1 based on their tolerability. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and AST levels <=ULN.
11098524|NCT01576406|EG002|Reported Event|Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily|Participants with mild hepatic impairment received Crizotinib 250 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Mild hepatic impairment was defined as total bilirubin level <=ULN and AST levels greater than (>) ULN or total bilirubin level > 1.0 to 1.5*ULN.
11098525|NCT01576406|EG003|Reported Event|Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily|Participants with moderate hepatic impairment received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level >1.5 to 3*ULN
11098526|NCT01576406|EG004|Reported Event|Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily|Participants with moderate hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level >1.5 to 3*ULN
11098527|NCT01576406|EG005|Reported Event|Severe Hepatic Impairment Crizotinib 250 mg Once Daily|Participants with severe hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Severe hepatic Impairment was defined as total bilirubin level >3*ULN.
11098528|NCT01576471|BG000|Baseline|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
11098529|NCT01576471|BG001|Baseline|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
11098530|NCT01576471|BG002|Baseline|Total|Total of all reporting groups
11098531|NCT01576471|FG000|Participant Flow|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
11098532|NCT01576471|FG001|Participant Flow|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
11098533|NCT01576471|OG000|Outcome|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
11098534|NCT01576471|OG001|Outcome|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
11098535|NCT01576471|EG000|Reported Event|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
11098536|NCT01576471|EG001|Reported Event|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
11098537|NCT01576484|BG000|Baseline|Placebo Participants in Parent Study|Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
11098538|NCT01576484|BG001|Baseline|Participants Previously Exposed to Alirocumab in Parent Study|Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
11098539|NCT01576484|BG002|Baseline|Total|Total of all reporting groups
11098540|NCT01576484|FG000|Participant Flow|Placebo Participants in Parent Study|Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
11098541|NCT01576484|FG001|Participant Flow|Participants Previously Exposed to Alirocumab in Parent Study|Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
11098542|NCT01576484|OG000|Outcome|Placebo Participants in Parent Study|Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
11098543|NCT01576484|OG001|Outcome|Participants Previously Exposed to Alirocumab in Parent Study|Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
11098544|NCT01576484|OG002|Outcome|All Participants|All participants who received placebo or alirocumab in the parent study (NCT01576484).
11098545|NCT01576484|OG000|Outcome|Placebo Matched to R727|Participants who received placebo in parent study has received a subcutaneous injection of placebo matched to alirocumab every 2 weeks for 4 years in this study.
11098546|NCT01576484|EG000|Reported Event|Placebo Participants in Parent Study|Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
11098547|NCT01576484|EG001|Reported Event|Participants Previously Exposed to Alirocumab in Parent Study|Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
11126239|NCT01899729|BG000|Baseline|IMO-8400 Regimen 1|"IMO-8400 at 0.075 mg/kq q wk x 12 wks~IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection"
11126240|NCT01899729|BG001|Baseline|IMO-8400 Regimen 2|"IMO-8400 at 0.15 mg/kg q wk x 12 wks~IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection"
11126241|NCT01899729|BG002|Baseline|IMO-8400 Regimen 3|"IMO-8400 at 0.3 mg/kg q wk x 12 wks~IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection"
11126242|NCT01899729|BG003|Baseline|IMO-8400 Regimen 4|IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
11126243|NCT01899729|BG004|Baseline|Placebo|"Saline (placebo) q wk x 12 wks~Saline Placebo: Saline q wk x 12 wk by subcutaneous injection"
11126244|NCT01899729|BG005|Baseline|Total|Total of all reporting groups
11126245|NCT01899729|FG000|Participant Flow|IMO-8400 Regimen 1|"IMO-8400 at 0.075 mg/kq q wk x 12 wks~IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection"
11126246|NCT01899729|FG001|Participant Flow|IMO-8400 Regimen 2|"IMO-8400 at 0.15 mg/kg q wk x 12 wks~IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection"
11126247|NCT01899729|FG002|Participant Flow|IMO-8400 Regimen 3|"IMO-8400 at 0.3 mg/kg q wk x 12 wks~IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection"
11126248|NCT01899729|FG003|Participant Flow|IMO-8400 Regimen 4|IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
11126249|NCT01899729|FG004|Participant Flow|Placebo|"Saline (placebo) q wk x 12 wks~Saline Placebo: Saline q wk x 12 wk by subcutaneous injection"
11126250|NCT01899729|OG000|Outcome|IMO-8400 Regimen 1|"IMO 8400 at 0.075 mg/kq q wk x 12 wks~IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection"
11126251|NCT01899729|OG001|Outcome|IMO-8400 Regimen 2|IMO-8400 at 0.15 mg/kg q wk x 12 wks IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
11126252|NCT01899729|OG002|Outcome|IMO-8400 Regimen 3|IMO-8400 at 0.3 mg/kg q wk x 12 wks IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
11126253|NCT01899729|OG003|Outcome|IMO-8400 Regimen 4|IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
11126254|NCT01899729|OG004|Outcome|Placebo|"Saline (placebo) q wk x 12 wks~Saline Placebo:~Saline q wk x 12 wk by subcutaneous injection"
11126255|NCT01899729|EG000|Reported Event|IMO-8400 Regimen 1|"IMO 8400 at 0.075 mg/kq q wk x 12 wks~IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection"
11126256|NCT01899729|EG001|Reported Event|IMO-8400 Regimen 2|"IMO-8400 at 0.15 mg/kg q wk x 12 wks~IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection"
11126257|NCT01899729|EG002|Reported Event|IMO-8400 Regimen 3|"IMO_8400 at 0.3 mg/kg q wk x 12 wks~IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection"
11126258|NCT01899729|EG003|Reported Event|IMO-8400 Regimen 4|IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
11126259|NCT01899729|EG004|Reported Event|Placebo|"Saline (placebo) q wk x 12 wks~Saline Placebo: Saline q wk x 12 wk by subcutaneous injection"
11098548|NCT01576523|BG000|Baseline|Low, Then Medium, CSL830 Dose|C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks.
11098549|NCT01576523|BG001|Baseline|Medium, Then Low, CSL830 Dose|C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks.
11098550|NCT01576523|BG002|Baseline|Medium, Then High, CSL830 Dose|C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks.
11098551|NCT01576523|BG003|Baseline|Low, Then High, CSL830 Dose|C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks.
11098552|NCT01576523|BG004|Baseline|High, Then Low, CSL830 Dose|C1-esterase inhibitor - single intravenous dose:(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will administered subcutaneously twice a week for four weeks.
11098553|NCT01576523|BG005|Baseline|High, Then Medium, CSL830 Dose|C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks.
11098554|NCT01576523|BG006|Baseline|Total|Total of all reporting groups
11098555|NCT01576523|FG000|Participant Flow|Low, Then Medium, CSL830 Dose|"C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830).~C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then~C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks."
11098556|NCT01576523|FG001|Participant Flow|Medium, Then Low, CSL830 Dose|"C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830).~C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then~C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks."
11098557|NCT01576523|FG002|Participant Flow|Medium, Then High, CSL830 Dose|"C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830).~C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then~C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks."
11098558|NCT01576523|FG003|Participant Flow|Low, Then High, CSL830 Dose|"C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830).~C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then~C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks."
11098559|NCT01576523|FG004|Participant Flow|High, Then Low, CSL830 Dose|"C1-esterase inhibitor - single intravenous dose:(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830).~C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then~C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will administered subcutaneously twice a week for four weeks."
11098560|NCT01576523|FG005|Participant Flow|High, Then Medium, CSL830 Dose|"C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830).~C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then~C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks."
11098561|NCT01576523|OG000|Outcome|CSL830 (Low Dose)|A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks
11098562|NCT01576523|OG001|Outcome|CSL830 (Medium Dose)|A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks
11098563|NCT01576523|OG002|Outcome|CSL830 (High Dose)|A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
11098564|NCT01576523|EG000|Reported Event|Berinert|C1-esterase inhibitor - single intravenous dose: A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
11098565|NCT01576523|EG001|Reported Event|CSL830 (Low Dose)|A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks
11098566|NCT01576523|EG002|Reported Event|CSL830 (Medium Dose)|A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks
11098567|NCT01576523|EG003|Reported Event|CSL830 (High Dose)|A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
11098568|NCT01576536|BG000|Baseline|Healthy Volunteers|Normal healthy volunteers
11098569|NCT01576536|FG000|Participant Flow|Healthy Volunteers|Normal healthy volunteers
11098570|NCT01576536|OG000|Outcome|Healthy Volunteers|Normal healthy volunteers
11098571|NCT01576536|EG000|Reported Event|Healthy Volunteers|Normal healthy volunteers
11098572|NCT01576588|BG000|Baseline|R-HDMP|"Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).~Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.~Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).~Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion."
11098573|NCT01576588|FG000|Participant Flow|R-HDMP|"Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).~Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.~Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).~Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion."
11098574|NCT01576588|OG000|Outcome|R-HDMP|"Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).~Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.~Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).~Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion."
11098575|NCT01576588|OG000|Outcome|R-HDMP|Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1)...
11098576|NCT01576588|EG000|Reported Event|R-HDMP|"Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).~Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.~Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).~Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion."
11098577|NCT01576705|BG000|Baseline|Thyroxin + Folinic Acid|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098578|NCT01576705|BG001|Baseline|Thyroxin+Folinic Acid Placebo|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098579|NCT01576705|BG002|Baseline|Thyroxin Placebo+ Folinic Acid|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098580|NCT01576705|BG003|Baseline|Thyroxin Placebo+ Folinic Acid Placebo|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098581|NCT01576705|BG004|Baseline|Total|Total of all reporting groups
11098582|NCT01576705|FG000|Participant Flow|Thyroxin + Folinic Acid|thyroid hormone and folinic acid: thyroid hormone 25microg in tablets folinic acid 5 mg in capsules
11098583|NCT01576705|FG001|Participant Flow|Thyroxin+Folinic Acid Placebo|thyroid hormone and folinic acid: thyroid hormone 25microg in tablets folinic acid placebo in capsules
11098584|NCT01576705|FG002|Participant Flow|Thyroxin Placebo+ Folinic Acid|thyroid hormone and folinic acid: thyroid hormone placebo in tablets folinic acid 5 mg in capsules
11098585|NCT01576705|FG003|Participant Flow|Thyroxin Placebo+ Folinic Acid Placebo|thyroid hormone and folinic acid: thyroid hormone placebo in tablets folinic acid placebo in capsules
11098586|NCT01576705|OG000|Outcome|Thyroxin + Folinic Acid|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098587|NCT01576705|OG001|Outcome|Thyroxin+Folinic Acid Placebo|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098588|NCT01576705|OG002|Outcome|Thyroxin Placebo+ Folinic Acid|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098589|NCT01576705|OG003|Outcome|Thyroxin Placebo+ Folinic Acid Placebo|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098590|NCT01576705|EG000|Reported Event|Thyroxin+Folinic Acid Placebo|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098591|NCT01576705|EG001|Reported Event|Thyroxin + Folinic Acid|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098592|NCT01576705|EG002|Reported Event|Thyroxin Placebo+ Folinic Acid|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098593|NCT01576705|EG003|Reported Event|Thyroxin Placebo+ Folinic Acid Placebo|thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
11098594|NCT01576718|BG000|Baseline|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098595|NCT01576718|BG001|Baseline|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098596|NCT01576718|BG002|Baseline|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098597|NCT01576718|BG003|Baseline|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098598|NCT01576718|BG004|Baseline|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098599|NCT01576718|BG005|Baseline|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098600|NCT01576718|BG006|Baseline|Total|Total of all reporting groups
11098601|NCT01576718|FG000|Participant Flow|Placebo MDPI (Run-In)|Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).
11098602|NCT01576718|FG001|Participant Flow|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098603|NCT01576718|FG002|Participant Flow|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098604|NCT01576718|FG003|Participant Flow|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098605|NCT01576718|FG004|Participant Flow|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098606|NCT01576718|FG005|Participant Flow|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11220600|NCT02335125|EG000|Reported Event|Intervention|"The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Psychotropic Drugs~Care Management"
11220601|NCT02335125|EG001|Reported Event|Usual Care|Only standard care practices will be administered to this arm.
11098607|NCT01576718|FG006|Participant Flow|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098608|NCT01576718|OG000|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098609|NCT01576718|OG001|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098610|NCT01576718|OG002|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098611|NCT01576718|OG003|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098612|NCT01576718|OG004|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098613|NCT01576718|OG005|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098614|NCT01576718|EG000|Reported Event|Flovent Diskus 250 mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098615|NCT01576718|EG001|Reported Event|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098616|NCT01576718|EG002|Reported Event|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098617|NCT01576718|EG003|Reported Event|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098618|NCT01576718|EG004|Reported Event|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098619|NCT01576718|EG005|Reported Event|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11098620|NCT01576783|BG000|Baseline|Docosahexaenoic Acid + Arachidonic Acid|"Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)~Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months"
11098621|NCT01576783|BG001|Baseline|Placebo|"Corn oil supplement~Placebo: 400 mg corn oil per day for 6 months"
11098622|NCT01576783|BG002|Baseline|Total|Total of all reporting groups
11098623|NCT01576783|FG000|Participant Flow|Docosahexaenoic Acid + Arachidonic Acid|"Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)~Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months"
11098624|NCT01576783|FG001|Participant Flow|Placebo|"Corn oil supplement~Placebo: 400 mg corn oil per day for 6 months"
11098625|NCT01576783|OG000|Outcome|Docosahexaenoic Acid + Arachidonic Acid|"Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)~Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months"
11098626|NCT01576783|OG001|Outcome|Placebo|"Corn oil supplement~Placebo: 400 mg corn oil per day for 6 months"
11098627|NCT01576783|EG000|Reported Event|Docosahexaenoic Acid + Arachidonic Acid|"Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)~Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months"
11098628|NCT01576783|EG001|Reported Event|Placebo|"Corn oil supplement~Placebo: 400 mg corn oil per day for 6 months"
11098629|NCT01576809|BG000|Baseline|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
11098630|NCT01576809|FG000|Participant Flow|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
11098631|NCT01576809|OG000|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
11098632|NCT01576809|EG000|Reported Event|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
11098633|NCT01576874|BG000|Baseline|Oxytocin|"Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.~Oxytocin: 40 IUs of oxytocin administered intranasally one time"
11098634|NCT01576874|BG001|Baseline|Placebo|"Participants will be administered 40 IUs of placebo nasal spray at one study visit.~placebo: placebo administered intranasally one time"
11098635|NCT01576874|BG002|Baseline|Total|Total of all reporting groups
11098636|NCT01576874|FG000|Participant Flow|Oxytocin|"Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.~Oxytocin: 40 IUs of oxytocin administered intranasally one time"
11098637|NCT01576874|FG001|Participant Flow|Placebo|"Participants will be administered 40 IUs of placebo nasal spray at one study visit.~placebo: placebo administered intranasally one time"
11098638|NCT01576874|OG000|Outcome|Oxytocin|"Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.~Oxytocin: 40 IUs of oxytocin administered intranasally one time"
11220602|NCT02335216|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220603|NCT02335216|FG000|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11098639|NCT01576874|OG001|Outcome|Placebo|"Participants will be administered 40 IUs of placebo nasal spray at one study visit.~placebo: placebo administered intranasally one time"
11098640|NCT01576874|EG000|Reported Event|Oxytocin|"Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.~Oxytocin: 40 IUs of oxytocin administered intranasally one time"
11098641|NCT01576874|EG001|Reported Event|Placebo|"Participants will be administered 40 IUs of placebo nasal spray at one study visit.~placebo: placebo administered intranasally one time"
11098642|NCT01576939|BG000|Baseline|Intensity Modulated RT Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
11098643|NCT01576939|FG000|Participant Flow|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
11098644|NCT01576939|OG000|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
11098645|NCT01576939|EG000|Reported Event|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
11098646|NCT01576952|BG000|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
11098647|NCT01576952|BG001|Baseline|Vehicle|DuraSite vehicle dosed BID
11098648|NCT01576952|BG002|Baseline|Total|Total of all reporting groups
11098649|NCT01576952|FG000|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
11098650|NCT01576952|FG001|Participant Flow|Vehicle|DuraSite vehicle dosed BID
11098651|NCT01576952|OG000|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
11098652|NCT01576952|OG001|Outcome|Vehicle|DuraSite vehicle dosed BID
11098653|NCT01576952|EG000|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
11098654|NCT01576952|EG001|Reported Event|Vehicle|DuraSite vehicle dosed BID
11098655|NCT01577108|BG000|Baseline|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
11098656|NCT01577108|BG001|Baseline|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
11098657|NCT01577108|BG002|Baseline|Total|Total of all reporting groups
11098658|NCT01577108|FG000|Participant Flow|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
11098659|NCT01577108|FG001|Participant Flow|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
11098660|NCT01577108|OG000|Outcome|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days~Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 21 in the probiotic group (42.9%)."
11098661|NCT01577108|OG001|Outcome|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days~Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 9 in the probiotic group (18.0%)."
11098662|NCT01577108|EG000|Reported Event|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
11220604|NCT02335216|OG000|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
11220605|NCT02335216|EG000|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11098663|NCT01577108|EG001|Reported Event|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
11098664|NCT01577160|BG000|Baseline|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
11098665|NCT01577160|FG000|Participant Flow|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's Clinical Global Impression - Improvement (CGI-I) score.
11098666|NCT01577160|OG000|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
11098667|NCT01577160|EG000|Reported Event|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
11098668|NCT01577186|BG000|Baseline|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion.
11098669|NCT01577186|FG000|Participant Flow|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion.
11098670|NCT01577186|OG000|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator's discretion.
11098671|NCT01577186|EG000|Reported Event|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion.
11098672|NCT01577238|BG000|Baseline|VivaGel|1% SPL7013 Gel: Vaginal gel, daily for 7 days
11098673|NCT01577238|BG001|Baseline|HEC Placebo|Placebo: Vaginal gel, daily for 7 days
11098674|NCT01577238|BG002|Baseline|Total|Total of all reporting groups
11098675|NCT01577238|FG000|Participant Flow|VivaGel|1% SPL7013 Gel: Vaginal gel, daily for 7 days
11098676|NCT01577238|FG001|Participant Flow|HEC Placebo|Placebo: Vaginal gel, daily for 7 days
11098677|NCT01577238|OG000|Outcome|VivaGel|1% SPL7013 Gel: Vaginal gel, daily for 7 days
11098678|NCT01577238|OG001|Outcome|HEC Placebo|Placebo: Vaginal gel, daily for 7 days
11098679|NCT01577238|EG000|Reported Event|VivaGel|1% SPL7013 Gel: Vaginal gel, daily for 7 days
11098680|NCT01577238|EG001|Reported Event|HEC Placebo|Placebo: Vaginal gel, daily for 7 days
11098681|NCT01577329|BG000|Baseline|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.~Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
11098682|NCT01577329|BG001|Baseline|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
11098683|NCT01577329|BG002|Baseline|Total|Total of all reporting groups
11098684|NCT01577329|FG000|Participant Flow|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.~Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
11098685|NCT01577329|FG001|Participant Flow|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
11098686|NCT01577329|OG000|Outcome|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.~Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
11098687|NCT01577329|OG001|Outcome|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
11098688|NCT01577329|EG000|Reported Event|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.~Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
11098689|NCT01577329|EG001|Reported Event|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
11098690|NCT01577381|BG000|Baseline|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
11098691|NCT01577381|BG001|Baseline|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
11098692|NCT01577381|BG002|Baseline|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
11098693|NCT01577381|BG003|Baseline|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
11098694|NCT01577381|BG004|Baseline|Total|Total of all reporting groups
11098695|NCT01577381|FG000|Participant Flow|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
11098696|NCT01577381|FG001|Participant Flow|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
11220606|NCT02335229|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220607|NCT02335229|FG000|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220608|NCT02335229|OG000|Outcome|Subjects Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
11220609|NCT02335229|EG000|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220610|NCT02335294|BG000|Baseline|Protocol v1-4 TRV130 0.1 mg|TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
11220611|NCT02335294|BG001|Baseline|Protocol v1-4 Morphine|Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
11220612|NCT02335294|BG002|Baseline|Protocol v1-4 Placebo|Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
11220613|NCT02335294|BG003|Baseline|Protocol v5 TRV130 0.35 mg|TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
11220614|NCT02335294|BG004|Baseline|Protocol v5 Morphine|Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
11220615|NCT02335294|BG005|Baseline|Protocol v5 Placebo|Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
11220616|NCT02335294|BG006|Baseline|Total|Total of all reporting groups
11220617|NCT02335294|FG000|Participant Flow|Protocol v1-4 TRV130 0.1 mg|TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
11220618|NCT02335294|FG001|Participant Flow|Protocol v1-4 Morphine|Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
11220619|NCT02335294|FG002|Participant Flow|Protocol v1-4 Placebo|Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
11220620|NCT02335294|FG003|Participant Flow|Protocol v5 TRV130 0.35 mg|TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
11220621|NCT02335294|FG004|Participant Flow|Protocol v5 Morphine|Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
11220622|NCT02335294|FG005|Participant Flow|Protocol v5 Placebo|Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
11220623|NCT02335294|OG000|Outcome|Protocol v1-4 TRV130 0.1 mg|TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
11220624|NCT02335294|OG001|Outcome|Protocol v1-4 Placebo|Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
11220625|NCT02335294|OG002|Outcome|Protocol v5 TRV130 0.35 mg|TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
11220626|NCT02335294|OG003|Outcome|Protocol v5 Placebo|Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
11220627|NCT02335294|OG001|Outcome|Protocol v1-4 Morphine|Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
11220628|NCT02335294|OG003|Outcome|Protocol v5 Morphine|Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
11220629|NCT02335294|EG000|Reported Event|Protocol v1-4 TRV130 0.1 mg|TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
11220630|NCT02335294|EG001|Reported Event|Protocol v1-4 Morphine|Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
11220631|NCT02335294|EG002|Reported Event|Protocol v1-4 Placebo|Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
11220632|NCT02335294|EG003|Reported Event|Protocol v5 TRV130 0.35 mg|TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
11220633|NCT02335294|EG004|Reported Event|Protocol v5 Morphine|Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
11220634|NCT02335294|EG005|Reported Event|Protocol v5 Placebo|Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
11220635|NCT02335346|BG000|Baseline|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
11220636|NCT02335346|FG000|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
11220637|NCT02335346|OG000|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
11220638|NCT02335346|EG000|Reported Event|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
11220639|NCT02335450|BG000|Baseline|Single Arm|All five participants had multiple sclerosis (MS). Four participants had relapsing-remitting MS and one participant had progressive-relating MS. Years since diagnosis of MS ranged from 9 years to 29 years.
11220640|NCT02335450|FG000|Participant Flow|Single Arm|The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks to track their progress in meeting their activity goals and keep a daily physical activity log.
11220641|NCT02335450|OG000|Outcome|Single Arm|The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.
11220642|NCT02335450|OG000|Outcome|Single Arm Mean Baseline Score|The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks to track their progress in meeting their activity goals and keep a daily physical activity log.
11220643|NCT02335450|OG001|Outcome|Single Arm Mean Post-study Score|The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks to track their progress in meeting their activity goals and keep a daily physical activity log.
11220644|NCT02335450|OG000|Outcome|Single Arm Mean Baseline Score|The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.
11220645|NCT02335450|OG001|Outcome|Single Arm Mean Post-study Score|The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.
11220646|NCT02335450|OG000|Outcome|Single Arm Baseline Mean Score|The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.
11220647|NCT02335450|OG001|Outcome|Single Arm Post-study Mean Score|The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.
11220648|NCT02335450|EG000|Reported Event|Single Arm|"The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks and maintain a daily physical activity log to track their progress in meeting their activity goals.~Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week."
11220649|NCT02335489|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220650|NCT02335489|FG000|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
11220651|NCT02335489|OG000|Outcome|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220652|NCT02335489|EG000|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220653|NCT02335502|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220654|NCT02335502|FG000|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220655|NCT02335502|OG000|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
11220656|NCT02335502|EG000|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11220657|NCT02335710|BG000|Baseline|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates~Journey II BCS TKA"
11220658|NCT02335710|BG001|Baseline|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
11220659|NCT02335710|BG002|Baseline|Total|Total of all reporting groups
11220660|NCT02335710|FG000|Participant Flow|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
11220661|NCT02335710|FG001|Participant Flow|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
11220662|NCT02335710|OG000|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
11220663|NCT02335710|OG001|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
11220664|NCT02335710|EG000|Reported Event|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
11220665|NCT02335710|EG001|Reported Event|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
11220666|NCT02335905|BG000|Baseline|Ceftaroline Fosamil|"IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour). The dose may vary with age.~Ceftaroline Fosamil: IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) for children 2 years of age - 17 years of age (inclusive). IV Ceftarloine Fosamil 10 mg/kg infused 120 (± 10) minutes q8h (± 1 hour) for children 1 years of age - less than 2 years of age (inclusive)."
11220667|NCT02335905|FG000|Participant Flow|Ceftaroline Fosamil|"IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour). The dose may vary with age.~Ceftaroline Fosamil: IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) for children 2 years of age - 17 years of age (inclusive). IV Ceftarloine Fosamil 10 mg/kg infused 120 (± 10) minutes q8h (± 1 hour) for children 1 years of age - less than 2 years of age (inclusive)."
11220668|NCT02335905|OG000|Outcome|Ceftaroline Fosamil|"IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour). The dose may vary with age.~Ceftaroline Fosamil: IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) for children 2 years of age - 17 years of age (inclusive). IV Ceftarloine Fosamil 10 mg/kg infused 120 (± 10) minutes q8h (± 1 hour) for children 1 years of age - less than 2 years of age (inclusive)."
11220669|NCT02335905|EG000|Reported Event|Ceftaroline Fosamil|"IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour). The dose may vary with age.~Ceftaroline Fosamil: IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) for children 2 years of age - 17 years of age (inclusive). IV Ceftarloine Fosamil 10 mg/kg infused 120 (± 10) minutes q8h (± 1 hour) for children 1 years of age - less than 2 years of age (inclusive)."
11220670|NCT02335983|BG000|Baseline|RRMM Dose-evaluation: Carfilzomib 56 mg/m²|"Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220671|NCT02335983|BG001|Baseline|RRMM Dose-evaluation: Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220672|NCT02335983|BG002|Baseline|RRMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220673|NCT02335983|BG003|Baseline|NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²|"Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220674|NCT02335983|BG004|Baseline|NDMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220675|NCT02335983|BG005|Baseline|NDMM Dose-expansion: Carfilzomib 56 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220676|NCT02335983|BG006|Baseline|Total|Total of all reporting groups
11098697|NCT01577381|FG002|Participant Flow|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
11098698|NCT01577381|FG003|Participant Flow|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
11098699|NCT01577381|OG000|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
11098700|NCT01577381|OG001|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
11098701|NCT01577381|OG002|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
11098702|NCT01577381|OG003|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
11098703|NCT01577381|EG000|Reported Event|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
11098704|NCT01577381|EG001|Reported Event|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
11098705|NCT01577381|EG002|Reported Event|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
11098706|NCT01577381|EG003|Reported Event|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
11098707|NCT01577537|BG000|Baseline|VivaGel|1% SPL7013 Gel: Vaginal gel, daily for 7 days
11098708|NCT01577537|BG001|Baseline|HEC Placebo|Placebo: Vaginal gel, daily for 7 days
11098709|NCT01577537|BG002|Baseline|Total|Total of all reporting groups
11098710|NCT01577537|FG000|Participant Flow|VivaGel|1% SPL7013 Gel: Vaginal gel, daily for 7 days
11098711|NCT01577537|FG001|Participant Flow|HEC Placebo|Placebo: Vaginal gel, daily for 7 days
11098712|NCT01577537|OG000|Outcome|VivaGel|1% SPL7013 Gel: Vaginal gel, daily for 7 days
11098713|NCT01577537|OG001|Outcome|HEC Placebo|Placebo: Vaginal gel, daily for 7 days
11098714|NCT01577537|EG000|Reported Event|VivaGel|1% SPL7013 Gel: Vaginal gel, daily for 7 days
11098715|NCT01577537|EG001|Reported Event|HEC Placebo|Placebo: Vaginal gel, daily for 7 days
11098716|NCT01577706|BG000|Baseline|All Study Participants|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
11098717|NCT01577706|FG000|Participant Flow|Dextroamphetamine, Alprazolam, Placebo Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
11098718|NCT01577706|FG001|Participant Flow|Alprazolam, Dextroamphetamine, Placebo Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
11098719|NCT01577706|FG002|Participant Flow|Placebo, Dextroamphetamine, Alprazolam Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
11098720|NCT01577706|OG000|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
11098721|NCT01577706|OG001|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
11098722|NCT01577706|OG002|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
11098723|NCT01577706|EG000|Reported Event|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
11098724|NCT01577706|EG001|Reported Event|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
11098725|NCT01577706|EG002|Reported Event|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo, single-dose, 1-day"
11098726|NCT01577732|BG000|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
11098727|NCT01577732|FG000|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
11098728|NCT01577732|OG000|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
11098729|NCT01577732|EG000|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
11098730|NCT01577745|BG000|Baseline|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098731|NCT01577745|BG001|Baseline|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098732|NCT01577745|BG002|Baseline|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098733|NCT01577745|BG003|Baseline|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098734|NCT01577745|BG004|Baseline|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098735|NCT01577745|BG005|Baseline|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
11098736|NCT01577745|BG006|Baseline|Total|Total of all reporting groups
11098737|NCT01577745|FG000|Participant Flow|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute intravenous (IV) infusion on Day 1 of each 21-day cycle.
11098738|NCT01577745|FG001|Participant Flow|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098739|NCT01577745|FG002|Participant Flow|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098740|NCT01577745|FG003|Participant Flow|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098741|NCT01577745|FG004|Participant Flow|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098742|NCT01577745|FG005|Participant Flow|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
11098743|NCT01577745|OG000|Outcome|MEDI0639|Participants received MEDI0639, in dose escalation phase starting from dose level 1 to 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098744|NCT01577745|OG000|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098745|NCT01577745|OG001|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098746|NCT01577745|OG002|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098747|NCT01577745|OG003|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098748|NCT01577745|OG004|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098749|NCT01577745|OG005|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
11098750|NCT01577745|OG005|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098751|NCT01577745|OG003|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle..
11098752|NCT01577745|OG004|Outcome|MMEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098753|NCT01577745|OG005|Outcome|MMEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098754|NCT01577745|EG000|Reported Event|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098755|NCT01577745|EG001|Reported Event|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098756|NCT01577745|EG002|Reported Event|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098757|NCT01577745|EG003|Reported Event|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098758|NCT01577745|EG004|Reported Event|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
11098759|NCT01577745|EG005|Reported Event|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
11098760|NCT01577758|BG000|Baseline|All Participants|All participants who participated in the Dose Escalation and mCRC Expansion Phases.
11098761|NCT01577758|FG000|Participant Flow|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098762|NCT01577758|FG001|Participant Flow|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098763|NCT01577758|FG002|Participant Flow|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098764|NCT01577758|FG003|Participant Flow|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098765|NCT01577758|FG004|Participant Flow|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098766|NCT01577758|FG005|Participant Flow|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098767|NCT01577758|FG006|Participant Flow|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098768|NCT01577758|FG007|Participant Flow|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
11098769|NCT01577758|OG000|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11220677|NCT02335983|FG000|Participant Flow|RRMM Dose-evaluation: Carfilzomib 56 mg/m²|"Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220678|NCT02335983|FG001|Participant Flow|RRMM Dose-evaluation: Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220679|NCT02335983|FG002|Participant Flow|RRMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220680|NCT02335983|FG003|Participant Flow|NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²|"Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220681|NCT02335983|FG004|Participant Flow|NDMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220682|NCT02335983|FG005|Participant Flow|NDMM Dose-expansion: Carfilzomib 56 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220683|NCT02335983|OG000|Outcome|RRMM Dose-evaluation: Carfilzomib 56 mg/m²|"Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220684|NCT02335983|OG001|Outcome|RRMM Dose-evaluation: Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220685|NCT02335983|OG002|Outcome|RRMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220686|NCT02335983|OG003|Outcome|NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²|"Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220687|NCT02335983|OG004|Outcome|NDMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11098770|NCT01577758|OG001|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11220688|NCT02335983|OG005|Outcome|NDMM Dose-expansion: Carfilzomib 56 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220689|NCT02335983|OG000|Outcome|Carfilzomib 56 mg/m²|Participants who received carfilzomib 56 mg/m² on Cycle 1 day 8.
11220690|NCT02335983|OG001|Outcome|Carfilzomib 70 mg/m²|Participants who received carfilzomib 70 mg/m² on Cycle 1 day 8.
11220691|NCT02335983|OG003|Outcome|RRMM: Combined Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220692|NCT02335983|OG004|Outcome|NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²|"Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220693|NCT02335983|OG005|Outcome|NDMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220694|NCT02335983|OG006|Outcome|NDMM: Combined Carfilzomib 70 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220695|NCT02335983|OG007|Outcome|NDMM Dose-expansion: Carfilzomib 56 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220696|NCT02335983|OG003|Outcome|RRMM: Combined Carfilzomib 70 mg/m²|Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
11220697|NCT02335983|OG006|Outcome|NDMM: Combined Carfilzomib 70 mg/m²|Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
11220698|NCT02335983|EG000|Reported Event|RRMM Dose-evaluation: Carfilzomib 56 mg/m²|"Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11098771|NCT01577758|OG002|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11220699|NCT02335983|EG001|Reported Event|RRMM Dose-evaluation: Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220700|NCT02335983|EG002|Reported Event|RRMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220701|NCT02335983|EG003|Reported Event|NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²|"Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220702|NCT02335983|EG004|Reported Event|NDMM Dose-expansion: Carfilzomib 70 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220703|NCT02335983|EG005|Reported Event|NDMM Dose-expansion: Carfilzomib 56 mg/m²|"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.~Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8."
11220704|NCT02336074|BG000|Baseline|Control (Arm A - ART Only)|Combination Antiretroviral Therapy (cART) preferably including raltegravir prescribed at week 0 for the duration of the study up to post-randomisation week 18 (42 weeks in total)
11220705|NCT02336074|BG001|Baseline|Intervention (Arm B - ART + Vaccines + Vorinostat)|Combination Antiretroviral Therapy (cART) preferably including raltegravir prescribed at week 0 for the duration of the study up to post-randomisation week 18 (42 weeks in total) Plus ChAdV63.HIVconsv prime (post-randomisation week 00) and MVA.HIVconsv boost (post randomisation week 08 day 1) vaccines; followed by a 28-day course of vorinostat (10 doses in total).
11220706|NCT02336074|BG002|Baseline|Total|Total of all reporting groups
11220707|NCT02336074|FG000|Participant Flow|Control|Participants received combination Antiretroviral Therapy (cART) preferably including raltegravir prescribed for the duration of the study
11220708|NCT02336074|FG001|Participant Flow|Intervention|Participants received combination Antiretroviral Therapy (cART) preferably including raltegravir prescribed for the duration of the study Plus ChAdV63.HIVconsv prime (post-randomisation week 00) and MVA.HIVconsv boost (post randomisation week 08 day 1) vaccines; followed by a 28-day course of vorinostat (10 doses in total).
11220709|NCT02336074|OG000|Outcome|Control (Arm A - ART Only)|Combination Antiretroviral Therapy (cART) preferably including raltegravir prescribed at week 0 for the duration of the study up to post-randomisation week 18 (42 weeks in total)
11220710|NCT02336074|OG001|Outcome|Intervention (Arm B - ART + Vaccines + Vorinostat)|Combination Antiretroviral Therapy (cART) preferably including raltegravir prescribed at week 0 for the duration of the study up to post-randomisation week 18 (42 weeks in total) Plus ChAdV63.HIVconsv prime (post-randomisation week 00) and MVA.HIVconsv boost (post randomisation week 08 day 1) vaccines; followed by a 28-day course of vorinostat (10 doses in total).
11220711|NCT02336074|OG000|Outcome|Control (Arm A - ART Only)|"Combination Antiretroviral Therapy (cART): Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir + ritonavir. Prescribed at week 0 for the duration of the study.~Raltegravir: All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle."
11220712|NCT02336074|OG001|Outcome|Intervention (Arm B - ART + Vaccines + Vorinostat)|"ART plus vaccines plus vorinostat~Combination Antiretroviral Therapy (cART): Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir + ritonavir. Prescribed at week 0 for the duration of the study.~Raltegravir: All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle.~Vorinostat: Vorinostat (suberoylanilide hydroxamic acid abbreviated to SAHA) inhibits the histone deacetylases HDAC1, HDAC2, HDA"
11220713|NCT02336074|OG000|Outcome|Control (Arm A - ART Only)|"ART only~Combination Antiretroviral Therapy (cART): Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir + ritonavir. Prescribed at week 0 for the duration of the study.~Raltegravir: All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle."
11220714|NCT02336074|OG000|Outcome|Control (Arm A - ART Only)|"ART only~Raltegravir: All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle."
11220715|NCT02336074|OG000|Outcome|Intervention (Arm B - ART + Vaccines + Vorinostat)|"ART plus vaccines plus vorinostat~Combination Antiretroviral Therapy (cART): Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir + ritonavir. Prescribed at week 0 for the duration of the study.~Raltegravir: All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle.~Vorinostat: Vorinostat (suberoylanilide hydroxamic acid abbreviated to SAHA) inhibits the histone deacetylases HDAC1, HDAC2, HDA"
11220716|NCT02336074|EG000|Reported Event|Control|"ART only~Combination ART (cART) preferably including raltegravir (control)"
11220717|NCT02336074|EG001|Reported Event|Intervention|"ART plus vaccines plus vorinostat~Combination ART (cART) preferably including raltegravir* plus ChAdV63.HIVconsv (ChAd) prime and MVA.HIVconsv (MVA) boost vaccines; followed by a 28-day course of vorinostat (10 doses in total)."
11220718|NCT02336165|BG000|Baseline|Cohort A|Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.
11220719|NCT02336165|BG001|Baseline|Cohort B|Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.
11220720|NCT02336165|BG002|Baseline|Cohort B2|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220721|NCT02336165|BG003|Baseline|Cohort B3|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
10852376|NCT00312208|BG000|Baseline|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
11220722|NCT02336165|BG004|Baseline|Cohort C|"Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220723|NCT02336165|BG005|Baseline|Total|Total of all reporting groups
11220724|NCT02336165|FG000|Participant Flow|Cohort A|Subjects with newly diagnosed unmethlyated O^6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) glioblastoma (GBM) receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.
11220725|NCT02336165|FG001|Participant Flow|Cohort B|Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.
11220726|NCT02336165|FG002|Participant Flow|Cohort B2|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220727|NCT02336165|FG003|Participant Flow|Cohort B3|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220728|NCT02336165|FG004|Participant Flow|Cohort C|"Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220729|NCT02336165|OG000|Outcome|Cohort A|Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.
11220730|NCT02336165|OG000|Outcome|Cohort B|Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.
11220731|NCT02336165|OG001|Outcome|Cohort B2|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220732|NCT02336165|OG002|Outcome|Cohort B3|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220733|NCT02336165|OG000|Outcome|Cohort C|"Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220734|NCT02336165|OG001|Outcome|Cohort B|Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.
11220735|NCT02336165|OG002|Outcome|Cohort B2|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
10852377|NCT00312208|BG001|Baseline|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
10852378|NCT00312208|BG002|Baseline|Total|Total of all reporting groups
11220736|NCT02336165|OG003|Outcome|Cohort B3|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220737|NCT02336165|OG004|Outcome|Cohort C|"Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220738|NCT02336165|EG000|Reported Event|Cohort A|Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.
11220739|NCT02336165|EG001|Reported Event|Cohort B|Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.
11220740|NCT02336165|EG002|Reported Event|Cohort B2|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220741|NCT02336165|EG003|Reported Event|Cohort B3|"Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11098772|NCT01577758|OG003|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098773|NCT01577758|OG004|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098774|NCT01577758|OG005|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098775|NCT01577758|OG006|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098776|NCT01577758|OG000|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
11098777|NCT01577758|OG001|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
11098778|NCT01577758|OG007|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
11098779|NCT01577758|OG000|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098780|NCT01577758|EG000|Reported Event|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098781|NCT01577758|EG001|Reported Event|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098782|NCT01577758|EG002|Reported Event|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098783|NCT01577758|EG003|Reported Event|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098784|NCT01577758|EG004|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098785|NCT01577758|EG005|Reported Event|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098786|NCT01577758|EG006|Reported Event|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
11098787|NCT01577966|BG000|Baseline|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
11098788|NCT01577966|FG000|Participant Flow|Sulfasalazine|Sulfasalazine
11098789|NCT01577966|OG000|Outcome|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
11098790|NCT01577966|EG000|Reported Event|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
11098791|NCT01578031|BG000|Baseline|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
11098792|NCT01578031|BG001|Baseline|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
11098793|NCT01578031|BG002|Baseline|Obese Subjects Without OSA|"Control.~Usual Care: Usual care."
11098794|NCT01578031|BG003|Baseline|Non-obese Subjects Without OSA|"Control.~Usual Care: Usual care."
11098795|NCT01578031|BG004|Baseline|Total|Total of all reporting groups
11098796|NCT01578031|FG000|Participant Flow|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
11098797|NCT01578031|FG001|Participant Flow|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
11098798|NCT01578031|FG002|Participant Flow|Obese Subjects Without OSA|"Control.~Usual Care: Usual care."
11220742|NCT02336165|EG004|Reported Event|Cohort C|"Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W).~Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused."
11220743|NCT02336178|BG000|Baseline|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
11220744|NCT02336178|FG000|Participant Flow|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
11220745|NCT02336178|OG000|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
11220746|NCT02336178|OG001|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
11098799|NCT01578031|FG003|Participant Flow|Non-obese Subjects Without OSA|"Control.~Usual Care: Usual care."
11098800|NCT01578031|OG000|Outcome|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
11220747|NCT02336178|OG002|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
11220748|NCT02336178|OG003|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
11220749|NCT02336178|OG004|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
11220750|NCT02336178|OG005|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
11220751|NCT02336178|OG003|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
11220752|NCT02336178|OG004|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
11220753|NCT02336178|OG003|Outcome|Participants Receiving Prophylaxis Treatment|Participants received prophylaxis treatment with BeneFIX according to usual care in China and in accord with the China BeneFIX Package Insert. The treatment duration was 6 months (±7 days) or 50 Exposure Days (±5 EDs) whichever occurred first. On-demand treatment was given as needed.
11220754|NCT02336178|EG000|Reported Event|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant's treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
11220755|NCT02336282|BG000|Baseline|Overall Study|During campus visit, following randomized design each participant completed tDCS set to sham, tDCS equipment set to active condition, during two consecutive days. Participants who completed the campus visit session and evaluation then were to complete a single arm treatment of 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad.
11220756|NCT02336282|FG000|Participant Flow|Overall Study|Participants completed tDCS set to sham, tDCS equipment set to active condition, then were to complete 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad.
11220757|NCT02336282|OG000|Outcome|At Home Feasibility of tDCS Intervention|All participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad.
11220758|NCT02336282|OG000|Outcome|At Home tDCS - Baseline|Pre- At Home tDCS session
11220759|NCT02336282|OG001|Outcome|At Home tDCS - Follow-Up|Post- At Home tDCS session
11220760|NCT02336282|OG000|Outcome|At Home tDCS - Baseline|Participants completed NCQ questionnaire examiner read
11220761|NCT02336282|OG001|Outcome|At Home tDCS - Follow-Up|Participants completed NCQ questionnaire examiner read
10975721|NCT00937326|EG002|Reported Event|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975722|NCT00937326|EG003|Reported Event|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975723|NCT00937326|EG004|Reported Event|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
10975724|NCT00937378|BG000|Baseline|SER120|All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
10975725|NCT00937378|BG001|Baseline|Placebo|All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study.
10975726|NCT00937378|BG002|Baseline|Total|Total of all reporting groups
10975727|NCT00937378|FG000|Participant Flow|SER120|All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
10975728|NCT00937378|FG001|Participant Flow|Placebo|All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study.
10975729|NCT00937378|OG000|Outcome|SER120|All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
10975730|NCT00937378|OG001|Outcome|Placebo|All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study.
10975731|NCT00937378|EG000|Reported Event|SER120|All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
10975732|NCT00937378|EG001|Reported Event|Placebo|All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study.
10975733|NCT00937391|BG000|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
10975734|NCT00937391|BG001|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
10975735|NCT00937391|BG002|Baseline|Total|Total of all reporting groups
10975736|NCT00937391|FG000|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-6661)|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Another group of participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
10975737|NCT00937391|OG000|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
10975738|NCT00937391|OG001|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
10975739|NCT00937391|OG000|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
10975740|NCT00937391|OG000|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
10975741|NCT00937391|OG000|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
10975742|NCT00937391|OG000|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
10975743|NCT00937391|OG000|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
10975744|NCT00937391|OG001|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
10975745|NCT00937391|OG002|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
10975746|NCT00937391|OG000|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
11220762|NCT02336282|OG000|Outcome|On Campus Sham tDCS|tDCS equipment set to sham condition.
10852379|NCT00312208|FG000|Participant Flow|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
10852380|NCT00312208|FG001|Participant Flow|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
10852381|NCT00312208|OG000|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
10852382|NCT00312208|OG001|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
10852383|NCT00312208|EG000|Reported Event|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
10852384|NCT00312208|EG001|Reported Event|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
10852385|NCT00312221|BG000|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10852386|NCT00312221|BG001|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10852387|NCT00312221|BG002|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
10852388|NCT00312221|BG003|Baseline|Total|Total of all reporting groups
11220763|NCT02336282|OG001|Outcome|On Campus tDCS|tDCS equipment set to active condition.
11220764|NCT02336282|EG000|Reported Event|On Campus Sham tDCS|tDCS equipment set to sham condition.
11220765|NCT02336282|EG001|Reported Event|On Campus tDCS|tDCS equipment set to active condition.
11220766|NCT02336282|EG002|Reported Event|At Home tDCS|Participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad.
11220767|NCT02336360|BG000|Baseline|Urine Analysis|Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
11220768|NCT02336360|FG000|Participant Flow|Urine Analysis|Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
11220769|NCT02336360|OG000|Outcome|Urine Analysis|Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
11220770|NCT02336360|EG000|Reported Event|Urine Analysis|Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
10852389|NCT00312221|FG000|Participant Flow|Run-in Period|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
10852390|NCT00312221|FG001|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10852391|NCT00312221|FG002|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
11220771|NCT02336373|BG000|Baseline|Hydroxyurea|hydroxyurea (HU) at 10 mg/kg daily
11220772|NCT02336373|FG000|Participant Flow|Hydroxurea|"Initiate hydroxyurea at 10 mg/kg daily and escalate hydroxyurea dose by 5 mg/kg/day every 8 weeks up to a maximum dose of 35 mg/kg/day if blood counts meet escalation criteria on at least 2 blood tests over eight weeks prior to dose increase.~hydroxyurea: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the PedsQL™ Sickle Cell Disease Module version 3.0 after 6 months at MTD, compared to entrance scores"
11220773|NCT02336373|OG000|Outcome|Hydroxurea|"Initiate hydroxyurea at 10 mg/kg daily and escalate hydroxyurea dose by 5 mg/kg/day every 8 weeks up to a maximum dose of 35 mg/kg/day if blood counts meet escalation criteria on at least 2 blood tests over eight weeks prior to dose increase.~hydroxyurea: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the PedsQL™ Sickle Cell Disease Module version 3.0 after 6 months at MTD, compared to entrance scores"
11220774|NCT02336373|OG000|Outcome|Hydroxyurea|Inititiate hydroxyurea and reach MTD
11220775|NCT02336373|OG000|Outcome|Hydroxyurea|hydroxyurea (HU) at 10 mg/kg daily
11220776|NCT02336373|EG000|Reported Event|Hydroxurea|"Initiate hydroxyurea at 10 mg/kg daily and escalate hydroxyurea dose by 5 mg/kg/day every 8 weeks up to a maximum dose of 35 mg/kg/day if blood counts meet escalation criteria on at least 2 blood tests over eight weeks prior to dose increase.~hydroxyurea: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the PedsQL™ Sickle Cell Disease Module version 3.0 after 6 months at MTD, compared to entrance scores"
10852392|NCT00312221|FG003|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
10852393|NCT00312221|OG000|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10852394|NCT00312221|OG001|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10852395|NCT00312221|OG002|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
10852396|NCT00312221|EG000|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear during the 12-week double-blind phase
10852397|NCT00312221|EG001|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
10975747|NCT00937391|OG001|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
10975748|NCT00937391|OG000|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
10975749|NCT00937391|OG001|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
10975750|NCT00937391|EG000|Reported Event|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
10975751|NCT00937391|EG001|Reported Event|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
10975752|NCT00937404|BG000|Baseline|IPV Group|Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
10975753|NCT00937404|FG000|Participant Flow|IPV Group|Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
10975754|NCT00937404|OG000|Outcome|IPV Group|Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
10975755|NCT00937404|EG000|Reported Event|IPV Group|Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
10975756|NCT00937495|BG000|Baseline|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10975757|NCT00937495|FG000|Participant Flow|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10975758|NCT00937495|OG000|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10975759|NCT00937495|EG000|Reported Event|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10975760|NCT00937521|BG000|Baseline|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975761|NCT00937521|BG001|Baseline|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10852398|NCT00312221|EG002|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours) during the 12-week double-blind phase.
10852399|NCT00312221|EG003|Reported Event|Run-in, Open-label BTDS 10 and 20|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
10975762|NCT00937521|BG002|Baseline|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975763|NCT00937521|BG003|Baseline|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975764|NCT00937521|BG004|Baseline|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975765|NCT00937521|BG005|Baseline|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975766|NCT00937521|BG006|Baseline|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
10975767|NCT00937521|BG007|Baseline|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
11220777|NCT02336438|BG000|Baseline|Baseline Phase (Control), Crossover to Treatment (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Glucomannan:~For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.~Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
11220778|NCT02336438|FG000|Participant Flow|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro® Continuous Glucose Monitor (CGM) device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
11220779|NCT02336438|OG000|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
11220780|NCT02336438|EG000|Reported Event|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Glucomannan:~For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.~Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
11220781|NCT02336451|BG000|Baseline|Arm 1 (PrALKi=Y, PrBRad=Y)|Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220782|NCT02336451|BG001|Baseline|Arm 2 (PrALKi=Y, PrBRad=N)|Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220783|NCT02336451|BG002|Baseline|Arm 3 (PrALKi=N, PrBRad=Y)|Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220784|NCT02336451|BG003|Baseline|Arm 4 (PrALKi=N, PrBRad=N)|Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220785|NCT02336451|BG004|Baseline|Arm 5 (LepDis)|Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
11220786|NCT02336451|BG005|Baseline|Total|Total of all reporting groups
11220787|NCT02336451|FG000|Participant Flow|Arm 1 (PrALKi=Y, PrBRad=Y)|Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220788|NCT02336451|FG001|Participant Flow|Arm 2 (PrALKi=Y, PrBRad=N)|Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
10852400|NCT00312338|BG000|Baseline|Infected Patients|Infected Patients
10852401|NCT00312338|BG001|Baseline|Healthy Subjects|Healthy Subjects
10852402|NCT00312338|BG002|Baseline|Total|Total of all reporting groups
10852403|NCT00312338|FG000|Participant Flow|Infected Patients|Infected Patients
10852404|NCT00312338|FG001|Participant Flow|Healthy Subjects|Healthy Subjects
10852405|NCT00312338|OG000|Outcome|Infected Patients|Infected Patients
10852406|NCT00312338|OG001|Outcome|Healthy Subjects|Healthy Subjects
10852407|NCT00312338|EG000|Reported Event|Infected Patients|Infected Patients
10852408|NCT00312338|EG001|Reported Event|Healthy Subjects|Healthy Subjects
10852409|NCT00312377|BG000|Baseline|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
11220789|NCT02336451|FG002|Participant Flow|Arm 3 (PrALKi=N, PrBRad=Y)|Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
10852410|NCT00312377|BG001|Baseline|Placebo Plus Docetaxel|Placebo plus docetaxel
10852411|NCT00312377|BG002|Baseline|Total|Total of all reporting groups
10852412|NCT00312377|FG000|Participant Flow|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
10852413|NCT00312377|FG001|Participant Flow|Placebo Plus Docetaxel|Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
10852414|NCT00312377|OG000|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
10852415|NCT00312377|OG001|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
10852416|NCT00312377|EG000|Reported Event|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
10852417|NCT00312377|EG001|Reported Event|Placebo Plus Docetaxel|Placebo plus docetaxel
10852418|NCT00312494|BG000|Baseline|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
10852419|NCT00312494|BG001|Baseline|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
10852420|NCT00312494|BG002|Baseline|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
10852421|NCT00312494|BG003|Baseline|Total|Total of all reporting groups
10852422|NCT00312494|FG000|Participant Flow|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
10852423|NCT00312494|FG001|Participant Flow|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
10852424|NCT00312494|FG002|Participant Flow|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
10852425|NCT00312494|OG000|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
11220790|NCT02336451|FG003|Participant Flow|Arm 4 (PrALKi=N, PrBRad=N)|Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
10852426|NCT00312494|OG001|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
10852427|NCT00312494|OG002|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
10852428|NCT00312494|EG000|Reported Event|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
10852429|NCT00312494|EG001|Reported Event|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
10852430|NCT00312494|EG002|Reported Event|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
10878794|NCT00454246|BG002|Baseline|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10878795|NCT00454246|BG003|Baseline|Total|Total of all reporting groups
10878796|NCT00454246|FG000|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10878797|NCT00454246|FG001|Participant Flow|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10878798|NCT00454246|FG002|Participant Flow|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10878799|NCT00454246|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10878800|NCT00454246|OG001|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10878801|NCT00454246|OG002|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10975768|NCT00937521|BG008|Baseline|Total|Total of all reporting groups
10852431|NCT00312572|BG000|Baseline|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
10852432|NCT00312572|BG001|Baseline|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
10852433|NCT00312572|BG002|Baseline|Total|Total of all reporting groups
10852434|NCT00312572|FG000|Participant Flow|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
10852435|NCT00312572|FG001|Participant Flow|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
10852436|NCT00312572|OG000|Outcome|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
10852437|NCT00312572|OG001|Outcome|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
10852438|NCT00312572|OG002|Outcome|Combined Total|Combined percentages from BTDS 10/20 and BTDS 20
10852439|NCT00312572|EG000|Reported Event|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
10852440|NCT00312572|EG001|Reported Event|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
10852441|NCT00312572|EG002|Reported Event|Open-label Run-in Period - Vicodin|"N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily average pain over the last 24 hours score of 0 = none or 1 = mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in."
11220791|NCT02336451|FG004|Participant Flow|Arm 5 (LepDis)|Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
10852442|NCT00312663|BG000|Baseline|10ug Dose FMP011|"Falciparum Malaria Protein 11 with AS01B adjuvant~Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine"
10852443|NCT00312663|BG001|Baseline|50ug Dose FMP011|"Falciparum Malaria Protein 11 with AS01B adjuvant~Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine"
10852444|NCT00312663|BG002|Baseline|Infectivity Control (IC)|10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge
10852445|NCT00312663|BG003|Baseline|Total|Total of all reporting groups
10852446|NCT00312663|FG000|Participant Flow|10ug Dose FMP011|"Falciparum Malaria Protein 11 with AS01B adjuvant~Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine"
10852447|NCT00312663|FG001|Participant Flow|50ug Dose FMP011|"Falciparum Malaria Protein 11 with AS01B adjuvant~Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine"
10852448|NCT00312663|FG002|Participant Flow|Infectivity Controls (IC)|10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.
10852449|NCT00312663|OG000|Outcome|10ug Dose FMP011|"Falciparum Malaria Protein 11 with AS01B adjuvant~Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine"
10852450|NCT00312663|OG001|Outcome|50ug Dose FMP011|"Falciparum Malaria Protein 11 with AS01B adjuvant~Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine"
10852451|NCT00312663|OG002|Outcome|Infectivity Control (IC)|10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge
10852452|NCT00312663|OG002|Outcome|Infectivity Controls (IC)|10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.
10852453|NCT00312663|EG000|Reported Event|10ug Dose FMP011|"Falciparum Malaria Protein 11 with AS01B adjuvant~Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine"
10852454|NCT00312663|EG001|Reported Event|50ug Dose FMP011|"Falciparum Malaria Protein 11 with AS01B adjuvant~Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine"
10852455|NCT00312663|EG002|Reported Event|Infectivity Control (IC)|10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge
10852456|NCT00312702|BG000|Baseline|10µg Dose FMP011|"Falciparum Malaria Protein 11 with AS02A adjuvant~Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine"
10852457|NCT00312702|BG001|Baseline|50µg Dose FMP011|"Falciparum Malaria Protein 11 with AS02A adjuvant~Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine"
10878802|NCT00454246|EG000|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
10878803|NCT00454246|EG001|Reported Event|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
11220792|NCT02336451|OG000|Outcome|Arm 1 (PrALKi=Y, PrBRad=Y)|Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220793|NCT02336451|OG001|Outcome|Arm 2 (PrALKi=Y, PrBRad=N)|Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220794|NCT02336451|OG002|Outcome|Arm 3 (PrALKi=N, PrBRad=Y)|Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220795|NCT02336451|OG003|Outcome|Arm 4 (PrALKi=N, PrBRad=N)|Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220796|NCT02336451|OG004|Outcome|Arm 5 (LepDis)|Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
11220797|NCT02336451|OG000|Outcome|Ceritinib 750mg|Participants all received a dose of 750 mg orally in fasted state
11220798|NCT02336451|EG000|Reported Event|Arm 1 (PrALKi=Y, PrBRad=Y)|Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220799|NCT02336451|EG001|Reported Event|Arm 2 (PrALKi=Y, PrBRad=N)|Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220800|NCT02336451|EG002|Reported Event|Arm 3 (PrALKi=N, PrBRad=Y)|Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
11220801|NCT02336451|EG003|Reported Event|Arm 4 (PrALKi=N, PrBRad=N)|Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation
11220802|NCT02336451|EG004|Reported Event|Arm 5 (LepDis)|Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
11220803|NCT02336451|EG005|Reported Event|All Participants|All participants who participated in the study and received at least one (full or partial) dose of ceritinib and provided at least one evaluable PK blood sample
11220804|NCT02336555|BG000|Baseline|MK-8291 → Placebo|In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)
11220805|NCT02336555|BG001|Baseline|Placebo → MK-8291|In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)
11220806|NCT02336555|BG002|Baseline|Total|Total of all reporting groups
11220807|NCT02336555|FG000|Participant Flow|MK-8291 → Placebo|In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)
11220808|NCT02336555|FG001|Participant Flow|Placebo → MK-8291|In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)
11220809|NCT02336555|OG000|Outcome|MK-8291|Participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)
11220810|NCT02336555|OG001|Outcome|Placebo|Participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)
11220811|NCT02336555|EG000|Reported Event|MK-8291|Participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)
11220812|NCT02336555|EG001|Reported Event|Placebo|Participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)
11220813|NCT02336594|BG000|Baseline|Sequence ABCD|2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.
11220814|NCT02336594|BG001|Baseline|Sequence BACD|10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat
11220815|NCT02336594|BG002|Baseline|Sequence ABDC|2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
11220816|NCT02336594|BG003|Baseline|Sequence BADC|10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
11220817|NCT02336594|BG004|Baseline|Total|Total of all reporting groups
11220818|NCT02336594|FG000|Participant Flow|Sequence ABCD|Day 1 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 5 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 9 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal); Day 13 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal).
11220819|NCT02336594|FG001|Participant Flow|Sequence BACD|Day 1 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 5 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 9 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal); Day 13 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal).
11220820|NCT02336594|FG002|Participant Flow|Sequence ABDC|Day 1 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 5 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 9 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal); Day 13 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal).
11220821|NCT02336594|FG003|Participant Flow|Sequence BADC|Day 1 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 5 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 9 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal); Day 13 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal).
11220822|NCT02336594|OG000|Outcome|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
11220823|NCT02336594|OG001|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
11220824|NCT02336594|OG002|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
11220825|NCT02336594|OG003|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
11220826|NCT02336594|OG000|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
11220827|NCT02336594|OG001|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
11220828|NCT02336594|OG001|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
11220829|NCT02336594|EG000|Reported Event|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
11220830|NCT02336594|EG001|Reported Event|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
11220831|NCT02336594|EG002|Reported Event|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
11220832|NCT02336594|EG003|Reported Event|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
11220833|NCT02336607|BG000|Baseline|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
11220834|NCT02336607|BG001|Baseline|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
11220835|NCT02336607|BG002|Baseline|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
11220836|NCT02336607|BG003|Baseline|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
11220837|NCT02336607|BG004|Baseline|Total|Total of all reporting groups
10852458|NCT00312702|BG002|Baseline|Infectivity Control (IC)|"12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.~1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report."
10852459|NCT00312702|BG003|Baseline|Total|Total of all reporting groups
10852460|NCT00312702|FG000|Participant Flow|10µg Dose FMP011|"Falciparum Malaria Protein 11 with AS02A adjuvant~Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine"
10852461|NCT00312702|FG001|Participant Flow|50µg Dose FMP011|"Falciparum Malaria Protein 11 with AS02A adjuvant~Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine"
10852462|NCT00312702|FG002|Participant Flow|Infectivity Controls (IC)|"12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.~1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report."
10852463|NCT00312702|OG000|Outcome|10µg Dose FMP011|"Falciparum Malaria Protein 11 with AS02A adjuvant~Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine"
10852464|NCT00312702|OG001|Outcome|50µg Dose FMP011|"Falciparum Malaria Protein 11 with AS02A adjuvant~Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine"
10852465|NCT00312702|OG002|Outcome|Infectivity Control|"12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.~1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report."
10852466|NCT00312702|EG000|Reported Event|10µg Dose FMP011|"Falciparum Malaria Protein 11 with AS02A adjuvant~Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine"
10852467|NCT00312702|EG001|Reported Event|50µg Dose FMP011|"Falciparum Malaria Protein 11 with AS02A adjuvant~Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine"
10852468|NCT00312702|EG002|Reported Event|Infecticvity Control (IC)|"12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.~1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report."
11220838|NCT02336607|FG000|Participant Flow|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10852469|NCT00312728|BG000|Baseline|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
10852470|NCT00312728|FG000|Participant Flow|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
10852471|NCT00312728|OG000|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
10852472|NCT00312728|EG000|Reported Event|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
10852473|NCT00312845|BG000|Baseline|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
10852474|NCT00312845|BG001|Baseline|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
11220839|NCT02336607|FG001|Participant Flow|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
11220840|NCT02336607|FG002|Participant Flow|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
11220841|NCT02336607|FG003|Participant Flow|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10852475|NCT00312845|BG002|Baseline|Total|Total of all reporting groups
10852476|NCT00312845|FG000|Participant Flow|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
10852477|NCT00312845|FG001|Participant Flow|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
10852478|NCT00312845|OG000|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
10852479|NCT00312845|OG001|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
10975769|NCT00937521|FG000|Participant Flow|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10852480|NCT00312845|EG000|Reported Event|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
10852481|NCT00312845|EG001|Reported Event|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
10852482|NCT00312858|BG000|Baseline|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
10852483|NCT00312858|BG001|Baseline|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
10852484|NCT00312858|BG002|Baseline|Total|Total of all reporting groups
10852485|NCT00312858|FG000|Participant Flow|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
10852486|NCT00312858|FG001|Participant Flow|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
11220842|NCT02336607|OG000|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
11220843|NCT02336607|OG001|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
11220844|NCT02336607|OG002|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10852487|NCT00312858|OG000|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
10852488|NCT00312858|OG001|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
10852489|NCT00312858|EG000|Reported Event|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
10852490|NCT00312858|EG001|Reported Event|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
10852491|NCT00312884|BG000|Baseline|Usual Care|Recieved usual follow-up care
10852492|NCT00312884|BG001|Baseline|Intervention Arm|Received daily home monitoring
10852493|NCT00312884|BG002|Baseline|Total|Total of all reporting groups
10852494|NCT00312884|FG000|Participant Flow|Intervention Arm|Recieved home telemonitoring daily HomMed Telemonitoring System: The HomeMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
10852495|NCT00312884|FG001|Participant Flow|Usual Care|Received usual hospital care with no Telemonitoring
11220845|NCT02336607|OG003|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10852496|NCT00312884|OG000|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
10852497|NCT00312884|OG001|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
10852498|NCT00312884|EG000|Reported Event|Usual Care|Recieved usual hospital care
10852499|NCT00312884|EG001|Reported Event|Intervention Arm|Recieved telemonitoring daily via the HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
10852500|NCT00312897|BG000|Baseline|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
11220846|NCT02336607|EG000|Reported Event|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
11220847|NCT02336607|EG001|Reported Event|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
11220848|NCT02336607|EG002|Reported Event|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10852501|NCT00312897|BG001|Baseline|Omega 3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
10852502|NCT00312897|BG002|Baseline|Total|Total of all reporting groups
10852503|NCT00312897|FG000|Participant Flow|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
11220849|NCT02336607|EG003|Reported Event|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
11220850|NCT02336737|BG000|Baseline|SiennaXP Injection|"Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.~Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.~SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe~Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)"
11220851|NCT02336737|FG000|Participant Flow|SiennaXP Injection|"Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.~Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.~SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe~Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)~Isosulfan blue dye: Injection of a single dose of isosulfan blue dye"
11220852|NCT02336737|OG000|Outcome|SiennaXP Injection|"Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.~Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.~SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe~Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)~Isosulfan blue dye: Injection of a single dose of isosulfan blue dye"
11220853|NCT02336737|OG000|Outcome|SiennaXP Injection|"Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.~Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.~SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe~Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)"
10878804|NCT00454246|EG002|Reported Event|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
11220854|NCT02336737|EG000|Reported Event|SiennaXP Injection|"Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.~Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.~SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe~Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)~Isosulfan blue dye: Injection of a single dose of isosulfan blue dye"
11220855|NCT02336815|BG000|Baseline|Part 1|Participants with quad-exposed, double-class-refractory (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, but not an anti-CD38 mab) and penta-exposed, triple-class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, two dosing schedules (1) selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly on Days 1 and 3 for 3 weeks of each 4-week cycle (2) selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly continuously in 4-week cycles; until disease progression, death, or unacceptable toxicity (maximum duration of approximately 13 months).
10852504|NCT00312897|FG001|Participant Flow|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. Acids: 10 wk treatment period"
10852505|NCT00312897|OG000|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
10852506|NCT00312897|OG001|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
10852507|NCT00312897|EG000|Reported Event|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
10852508|NCT00312897|EG001|Reported Event|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
10852509|NCT00312923|BG000|Baseline|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
11220856|NCT02336815|BG001|Baseline|Part 2|Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, selinexor 80 mg PO plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).
11220857|NCT02336815|BG002|Baseline|Total|Total of all reporting groups
11220858|NCT02336815|FG000|Participant Flow|Part 1|Participants with quad-exposed, double-class-refractory (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, but not an anti-CD38 mab) and penta-exposed, triple-class-refractory multiple myeloma (MM) (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and the anti-CD38 mAb daratumumab) received, two dosing schedules (1) selinexor 80 milligrams (mg) plus low-dose dexamethasone 20 mg (Sd) twice-weekly on Days 1 and 3 for 3 weeks of each 4-week cycle (2) selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly continuously in 4-week cycles; until disease progression, death, or unacceptable toxicity (maximum duration of approximately 13 months).
11220859|NCT02336815|FG001|Participant Flow|Part 2|Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, selinexor 80 mg post oral (PO) plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).
10852510|NCT00312923|BG001|Baseline|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
11343052|NCT03722524|EG000|Reported Event|Patients With Arterial Hypertension|"The patient is included in the program if prior to the study his/her doctor decided to adjust treatment, targeted at the BP control improvement, by prescription of a triple FDC of amlodipine / indapamide / perindopril arginine. The prescription of the triple FDC of amlodipine / indapamide / perindopril arginine during the program is made by the doctor's decision according to the instructions for medical use of this FDC.~Presumably, each doctor will include 4 patients in average. It is planned to include 1,300 patients.~amlodipine / indapamide / perindopril arginine FDC: CCB / diuretic / ACE inhibitor"
10852511|NCT00312923|BG002|Baseline|Total|Total of all reporting groups
10852512|NCT00312923|FG000|Participant Flow|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
10852513|NCT00312923|FG001|Participant Flow|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
10852514|NCT00312923|OG000|Outcome|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
10852515|NCT00312923|OG001|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
10852516|NCT00312923|EG000|Reported Event|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
10852517|NCT00312923|EG001|Reported Event|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
10852518|NCT00313014|BG000|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10852519|NCT00313014|BG001|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10852520|NCT00313014|BG002|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
10852521|NCT00313014|BG003|Baseline|Total|Total of all reporting groups
10852522|NCT00313014|FG000|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10852523|NCT00313014|FG001|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10852524|NCT00313014|FG002|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
10852525|NCT00313014|OG000|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10852526|NCT00313014|OG001|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10852527|NCT00313014|OG002|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
11220860|NCT02336815|OG000|Outcome|Part 2|Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, selinexor 80 mg PO plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).
11220861|NCT02336815|OG000|Outcome|Part 1|Participants with quad-exposed, double-class-refractory (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, but not an anti-CD38 mab) and penta-exposed, triple-class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, two dosing schedules (1) selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly on Days 1 and 3 for 3 weeks of each 4-week cycle (2) selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly continuously in 4-week cycles; until disease progression, death, or unacceptable toxicity (maximum duration of approximately 13 months).
11220862|NCT02336815|OG001|Outcome|Part 2|Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, selinexor 80 mg PO plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).
11343053|NCT03722576|BG000|Baseline|Vidofludimus Calcium (VC)|"Daily dosing of VC over 6 months~Vidofludimus calcium: During the 6-month treatment period, subjects received 30 mg VC orally once daily. This was preceded by a lead-in dosing period where subjects received 15 mg VC once daily for 1 week."
10852528|NCT00313014|EG000|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10852529|NCT00313014|EG001|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10852530|NCT00313014|EG002|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
10852531|NCT00313014|EG003|Reported Event|Open-label Run-in Period, BTDS 10/20|Open-label BTDS 10 or 20 mcg/h applied for 7-day wear
10852532|NCT00313144|BG000|Baseline|Overall Study|
10852533|NCT00313144|FG000|Participant Flow|Overall Study|Participants were treated with ARALAST according to dose and frequency of infusions recommended by their physician.
10852534|NCT00313144|OG000|Outcome|Baseline|
10852535|NCT00313144|OG001|Outcome|Baseline to ≤6 Months|
10852536|NCT00313144|OG002|Outcome|>6 Months to ≤12 Months|
10852537|NCT00313144|OG003|Outcome|>12 Months to ≤18 Months|
10852538|NCT00313144|OG004|Outcome|>18 Months to ≤24 Months|
10852539|NCT00313144|OG000|Outcome|Baseline to ≤6 Months|
10852540|NCT00313144|OG001|Outcome|>6 Months to ≤12 Months|
10852541|NCT00313144|OG002|Outcome|>12 Months to ≤18 Months|
10852542|NCT00313144|OG003|Outcome|>18 Months to ≤24 Months|
10852543|NCT00313144|OG000|Outcome|Year Prior to Baseline|
10852544|NCT00313144|EG000|Reported Event|Overall Study|
10852545|NCT00313170|BG000|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
10852546|NCT00313170|BG001|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
10852547|NCT00313170|BG002|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
10852548|NCT00313170|BG003|Baseline|Total|Total of all reporting groups
10852549|NCT00313170|FG000|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
10852550|NCT00313170|FG001|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
10852551|NCT00313170|FG002|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
10852552|NCT00313170|OG000|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
10852553|NCT00313170|OG001|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
10852554|NCT00313170|OG002|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
10852555|NCT00313170|OG000|Outcome|Fulvestrant|Fulvestrant arms pooled
10852556|NCT00313170|EG000|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
10852557|NCT00313170|EG001|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
10852558|NCT00313170|EG002|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
10852559|NCT00313209|BG000|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
10852560|NCT00313209|BG001|Baseline|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
10852561|NCT00313209|BG002|Baseline|Total|Total of all reporting groups
10852562|NCT00313209|FG000|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
10852563|NCT00313209|FG001|Participant Flow|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
10852564|NCT00313209|OG000|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
10852565|NCT00313209|OG001|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
10852566|NCT00313209|EG000|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
10852567|NCT00313209|EG001|Reported Event|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
10852568|NCT00313300|BG000|Baseline|Placebo|Tablet of Placebo for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852569|NCT00313300|BG001|Baseline|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852570|NCT00313300|BG002|Baseline|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852571|NCT00313300|BG003|Baseline|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.~Approximately 6 months after the start of Phase B, this treatment group was terminated"
10852572|NCT00313300|BG004|Baseline|Apixaban 20 mg QD|"Tablet of apixaban, oral, for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.~Approximately 6 months after the start of Phase B, this treatment group was terminated."
10852573|NCT00313300|BG005|Baseline|Total|Total of all reporting groups
10852574|NCT00313300|FG000|Participant Flow|Placebo|Study was conducted in 2 Phases (A and B). A tablet of Placebo along with ≤ 165 mg of aspirin was given daily for 26 weeks. 75 mg of clopidogrel once a day (QD) was allowed at the investigator's discretion. After 547 subjects were randomized to Phase A, an independent Data and Safety Monitoring Board (DSMB) recommended expanding the randomization to 2 higher doses of apixaban (10 mg BID and 20 mg QD) in Phase B of the study. Approximately 6 months after the start of Phase B, the DSMB recommended apixaban high dose groups be terminated due to excess bleeding in those participants receiving aspirin and clopidogrel concomitantly with high dose apixaban. Treatment and any new randomization into these 2 groups was halted, while randomization and treatment in the placebo and lower dose apixaban groups continued. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
10975770|NCT00937521|FG001|Participant Flow|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975771|NCT00937521|FG002|Participant Flow|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975772|NCT00937521|FG003|Participant Flow|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975773|NCT00937521|FG004|Participant Flow|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975774|NCT00937521|FG005|Participant Flow|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975775|NCT00937521|FG006|Participant Flow|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
10975776|NCT00937521|FG007|Participant Flow|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
10975777|NCT00937521|OG000|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975778|NCT00937521|OG001|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975779|NCT00937521|OG002|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975780|NCT00937521|OG003|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975781|NCT00937521|OG004|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975782|NCT00937521|OG005|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975783|NCT00937521|OG006|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
10975784|NCT00937521|OG007|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
10852575|NCT00313300|FG001|Participant Flow|Apixaban 2.5mg BID|In both Phase A and Phase B of the study: Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
10852576|NCT00313300|FG002|Participant Flow|Apixaban 10mg QD|In both Phase A and Phase B of the study: Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
10852577|NCT00313300|FG003|Participant Flow|Apixaban 10mg BID|"Phase B of the Study: Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.~Approximately 6 months after the start of Phase B, the DSMB recommended that the 10 mg BID QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the 10 mg BID apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
10852578|NCT00313300|FG004|Participant Flow|Apixaban 20 mg QD|"Phase B of the Study: Tablet of Apixaban 20 mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.~Approximately 6 months after the start of Phase B, the DSMB recommended that the apixaban 20 mg QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
10852579|NCT00313300|OG000|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852580|NCT00313300|OG001|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852581|NCT00313300|OG002|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852582|NCT00313300|OG000|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852583|NCT00313300|OG003|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
10852584|NCT00313300|OG004|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
10852585|NCT00313300|OG000|Outcome|Placebo|Tablet of Placebo, oral, for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852586|NCT00313300|OG000|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
10852587|NCT00313300|EG000|Reported Event|Phase A+B Apixaban 10mg QD|Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.
10852588|NCT00313300|EG001|Reported Event|Phase A+B Apixaban 2.5mg BID|Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.
10852589|NCT00313300|EG002|Reported Event|Phase A+B Placebo|Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.
10852590|NCT00313300|EG003|Reported Event|Phase B Apixaban 10mg BID|Participants treated with at least one dose of 10 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
10852591|NCT00313300|EG004|Reported Event|Phase B Apixaban 10mg QD|Participants treated with at least one dose of 10 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
10852592|NCT00313300|EG005|Reported Event|Phase B Apixaban 20mg QD|Participants treated with at least one dose of 20 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
10852593|NCT00313300|EG006|Reported Event|Phase B Apixaban 2.5mg BID|Participants treated with at least one dose of 2.5 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
10852594|NCT00313300|EG007|Reported Event|Phase B Placebo|Participants treated with at least one dose of Placebo during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
10852595|NCT00313313|BG000|Baseline|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
10852596|NCT00313313|BG001|Baseline|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
10852597|NCT00313313|BG002|Baseline|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
10852598|NCT00313313|BG003|Baseline|Total|Total of all reporting groups
10852599|NCT00313313|FG000|Participant Flow|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
10852600|NCT00313313|FG001|Participant Flow|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
10975785|NCT00937521|OG001|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
10852601|NCT00313313|FG002|Participant Flow|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
10852602|NCT00313313|OG000|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
10852603|NCT00313313|OG001|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
10852604|NCT00313313|OG002|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
10852605|NCT00313313|EG000|Reported Event|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
10852606|NCT00313313|EG001|Reported Event|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
10852607|NCT00313313|EG002|Reported Event|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
10852608|NCT00313443|BG000|Baseline|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
10852609|NCT00313443|FG000|Participant Flow|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
10852610|NCT00313443|OG000|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
10852611|NCT00313443|EG000|Reported Event|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
10852612|NCT00313560|BG000|Baseline|Erlotinib and EBRT After Pancreatectomy|All patients received RT, Erlotinib and Capecitabine, followed by gemcitabine/erlotinib
11220863|NCT02336815|OG000|Outcome|Part 1|Participants with quad-exposed, double-class-refractory (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, but not an anti-CD38 mab) and penta-exposed, triple-class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, two dosing schedules (1) selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly on Days 1 and 3 for 3 weeks of each 4-week cycle (2) selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly continuously in 4-week cycles; until disease progression, death, or unacceptable toxicity (maximum duration of approximately 13 months
10852613|NCT00313560|FG000|Participant Flow|Erlotinib and EBRT After Pancreatectomy|Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine.
10852614|NCT00313560|OG000|Outcome|Erlotinib and EBRT After Pancreatectomy|Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine, followed by adjuvant chemotherapy with gemcitabine/erlotinib.
10852615|NCT00313560|OG000|Outcome|Chemoradiation Plus Erlotinib|"Adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (Dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients).~erlotinib hydrochloride: Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)"
10852616|NCT00313560|OG001|Outcome|Adjuvant Gemcitabine Plus Erlotinib|Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.
10852617|NCT00313560|OG000|Outcome|Erlotinib and EBRT After Pancreatectomy|Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine.
10852618|NCT00313560|OG000|Outcome|Erlotinib and EBRT After Pancreatectomy|"Adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (Dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients).~Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.~erlotinib hydrochloride: Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)"
10852619|NCT00313560|EG000|Reported Event|Erlotinib and EBRT After Prostatectomy|"Patients receive oral erlotinib hydrochloride once a day for 3-5 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given orally"
10852620|NCT00313586|BG000|Baseline|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
10852621|NCT00313586|BG001|Baseline|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
10852622|NCT00313586|BG002|Baseline|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
10852623|NCT00313586|BG003|Baseline|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
10852624|NCT00313586|BG004|Baseline|Total|Total of all reporting groups
10852625|NCT00313586|FG000|Participant Flow|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
10852626|NCT00313586|FG001|Participant Flow|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
10852627|NCT00313586|FG002|Participant Flow|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
10852628|NCT00313586|FG003|Participant Flow|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
10852629|NCT00313586|OG000|Outcome|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
10852630|NCT00313586|OG001|Outcome|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
10852631|NCT00313586|OG002|Outcome|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
10852632|NCT00313586|OG003|Outcome|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
10852633|NCT00313586|EG000|Reported Event|Arm A (Azacitidine)|Patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
10852634|NCT00313586|EG001|Reported Event|Arm B (Azacitidine + Entinostat)|Patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
10852635|NCT00313612|BG000|Baseline|Treatment Stratum I: (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
10852636|NCT00313612|BG001|Baseline|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
10852637|NCT00313612|BG002|Baseline|Total|Total of all reporting groups
10852638|NCT00313612|FG000|Participant Flow|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
10852639|NCT00313612|FG001|Participant Flow|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
10852640|NCT00313612|OG000|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
10852641|NCT00313612|OG001|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
10852642|NCT00313612|EG000|Reported Event|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
10852643|NCT00313612|EG001|Reported Event|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
10852644|NCT00313703|BG000|Baseline|Migraine|met International Headache Society migraine criteria
10852645|NCT00313703|BG001|Baseline|Tension-type Headache|met International Headache Society tension-type headache criteria
10852646|NCT00313703|BG002|Baseline|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
10852647|NCT00313703|BG003|Baseline|Other|Met other International Headache Society criteria
10852648|NCT00313703|BG004|Baseline|Total|Total of all reporting groups
10852649|NCT00313703|FG000|Participant Flow|Migraine|met International Headache Society migraine criteria
10852650|NCT00313703|FG001|Participant Flow|Tension-type Headache|met International Headache Society tension-type headache criteria
10852651|NCT00313703|FG002|Participant Flow|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
10852652|NCT00313703|FG003|Participant Flow|Other|Met other International Headache Society criteria
10852653|NCT00313703|OG000|Outcome|Migraine|met International Headache Society migraine criteria
10852654|NCT00313703|OG001|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
10852655|NCT00313703|OG002|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
10852656|NCT00313703|OG003|Outcome|Other|Met other International Headache Society criteria
10852657|NCT00313703|EG000|Reported Event|Migraine|met International Headache Society migraine criteria
10852658|NCT00313703|EG001|Reported Event|Tension-type Headache|met International Headache Society tension-type headache criteria
10852659|NCT00313703|EG002|Reported Event|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
10852660|NCT00313703|EG003|Reported Event|Other|Met other International Headache Society criteria
10852661|NCT00313716|BG000|Baseline|Epo1/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 7 g/dl
10852662|NCT00313716|BG001|Baseline|Epo2/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 7 g/dl
10852663|NCT00313716|BG002|Baseline|Placebo/TT7 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 7 g/dl
10852664|NCT00313716|BG003|Baseline|Epo1/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 10 g/dl
10852665|NCT00313716|BG004|Baseline|Epo2/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 10 g/dl
10852666|NCT00313716|BG005|Baseline|Placebo/TT10 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 10 g/dl
10852667|NCT00313716|BG006|Baseline|Total|Total of all reporting groups
10852668|NCT00313716|FG000|Participant Flow|Epo1/TT7 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
10852669|NCT00313716|FG001|Participant Flow|Epo2/TT7 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
10852670|NCT00313716|FG002|Participant Flow|Placebo/TT7 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl
10852671|NCT00313716|FG003|Participant Flow|Epo1/TT10 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
10852672|NCT00313716|FG004|Participant Flow|Epo2/TT10 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
10852673|NCT00313716|FG005|Participant Flow|Placebo/TT10 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl
10852674|NCT00313716|OG000|Outcome|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
10852675|NCT00313716|OG001|Outcome|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
10852676|NCT00313716|OG002|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
10852677|NCT00313716|OG003|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
10852678|NCT00313716|OG004|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
10852679|NCT00313716|OG000|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
10852680|NCT00313716|OG001|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
10852681|NCT00313716|OG000|Outcome|Epo1 Group|Patients received 500 IU/kg erythropoietin within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
10852682|NCT00313716|OG001|Outcome|Epo2 Group|Patients received 500 IU/kg within 6 hrs after injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
10852683|NCT00313716|OG003|Outcome|TT7 Group|Patients had hemoglobin maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
10852684|NCT00313716|OG001|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 group, Epo2/TT10 group, and Placebo/TT10 group combined)
10852685|NCT00313716|EG000|Reported Event|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
10852686|NCT00313716|EG001|Reported Event|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
10852687|NCT00313716|EG002|Reported Event|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
10852688|NCT00313716|EG003|Reported Event|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
10852689|NCT00313716|EG004|Reported Event|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
10852690|NCT00313729|BG000|Baseline|Temozolomide|Single Arm Trial with single dose schedule of Temozolomide chemotherapy
10852691|NCT00313729|FG000|Participant Flow|Single Arm Study of Temozolomide for LGG Patients|Oral temozolomide at 200mg/m2 per day x5 days every 28 days for up to 12 cycles
10852692|NCT00313729|OG000|Outcome|Temozolomide|"Temozolomide~temozolomide: Chemotherapy"
10852693|NCT00313729|EG000|Reported Event|Temozolomide|"Temozolomide~temozolomide: Chemotherapy"
10852694|NCT00313781|BG000|Baseline|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
10852695|NCT00313781|BG001|Baseline|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
10852696|NCT00313781|BG002|Baseline|Total|Total of all reporting groups
10852697|NCT00313781|FG000|Participant Flow|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.
10852698|NCT00313781|FG001|Participant Flow|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
10852699|NCT00313781|FG002|Participant Flow|Docetaxel+Prednisone+CP-751,871 Crossover|"Participants from the Docetaxel+Prednisone group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles."
10852700|NCT00313781|OG000|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
10852701|NCT00313781|OG001|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
10852702|NCT00313781|OG002|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|"Participants from the Docetaxel+Prednisone group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles."
10852703|NCT00313781|OG001|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|"Participants from the Docetaxel+Prednisone group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles."
10852704|NCT00313781|EG000|Reported Event|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
10852705|NCT00313781|EG001|Reported Event|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
10852706|NCT00313781|EG002|Reported Event|Docetaxel+Prednisone+CP-751,871 Crossover|"Participants from the Docetaxel+Prednisone group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles."
10852707|NCT00313820|BG000|Baseline|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
10852708|NCT00313820|BG001|Baseline|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
10852709|NCT00313820|BG002|Baseline|Total|Total of all reporting groups
10852710|NCT00313820|FG000|Participant Flow|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
10852711|NCT00313820|FG001|Participant Flow|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
10878805|NCT00454324|BG000|Baseline|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
10852712|NCT00313820|OG000|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
10852713|NCT00313820|OG001|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
10852714|NCT00313820|EG000|Reported Event|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
10852715|NCT00313820|EG001|Reported Event|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
10852716|NCT00313846|BG000|Baseline|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
10852717|NCT00313846|BG001|Baseline|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
10852718|NCT00313846|BG002|Baseline|Total|Total of all reporting groups
10852719|NCT00313846|FG000|Participant Flow|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
10852720|NCT00313846|FG001|Participant Flow|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
10852721|NCT00313846|OG000|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
10852722|NCT00313846|OG001|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
10852723|NCT00313846|EG000|Reported Event|Double-blind Placebo Patch 5, 10, or 20|Reference treatment in the double-blind phase
10852724|NCT00313846|EG001|Reported Event|Double-blind BTDS 5, 10, or 20|Test treatments in the double-blind phase
10852725|NCT00313846|EG002|Reported Event|Open-label Run-in Period BTDS 5, 10, or 20|Open-label Run-in Period (less than or equal to 21 days): All subjects began treatment on BTDS 5 and titrated to a maximum of BTDS 20 to achieve effective pain control. Subjects were treated for a minimum of 3 days with any given dose of BTDS before up-titration to the next strength patch was considered. One down-titration was permitted. Subjects meeting protocol-defined criteria for adequate analgesia within 21 days were eligible for entry into the double-blind phase.
10852726|NCT00313911|BG000|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
10852727|NCT00313911|BG001|Baseline|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
10852728|NCT00313911|BG002|Baseline|Total|Total of all reporting groups
10852729|NCT00313911|FG000|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
10852730|NCT00313911|FG001|Participant Flow|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
10975786|NCT00937521|OG000|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
10852731|NCT00313911|OG000|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
10975787|NCT00937521|OG003|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
10852732|NCT00313911|OG001|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
10852733|NCT00313911|EG000|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
10852734|NCT00313911|EG001|Reported Event|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
10852735|NCT00314106|BG000|Baseline|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
10852736|NCT00314106|BG001|Baseline|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
10852737|NCT00314106|BG002|Baseline|Total|Total of all reporting groups
10852738|NCT00314106|FG000|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
10852739|NCT00314106|FG001|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
10852740|NCT00314106|OG000|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
10852741|NCT00314106|OG001|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
10852742|NCT00314106|EG000|Reported Event|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
10878806|NCT00454324|BG001|Baseline|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
11220864|NCT02336815|EG000|Reported Event|Part 1|Participants with quad-exposed, double-class-refractory (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, but not an anti-CD38 mab) and penta-exposed, triple-class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, two dosing schedules (1) Selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly on Days 1 and 3 for 3 weeks of each 4-week cycle (2) Selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly continuously in 4-week cycles; until disease progression, death, or unacceptable toxicity (maximum duration of approximately 13 months).
11220865|NCT02336815|EG001|Reported Event|Part 2|Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, Selinexor 80 mg post oral (PO) plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).
11220866|NCT02336958|BG000|Baseline|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
11220867|NCT02336958|BG001|Baseline|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
10878807|NCT00454324|BG002|Baseline|Total|Total of all reporting groups
10852743|NCT00314106|EG001|Reported Event|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
10852744|NCT00314132|BG000|Baseline|Placebo|Participants received a single injection of placebo on Day 0.
10852745|NCT00314132|BG001|Baseline|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
10852746|NCT00314132|BG002|Baseline|Total|Total of all reporting groups
10852747|NCT00314132|FG000|Participant Flow|Placebo|Participants received a single injection of placebo on Day 0.
11220868|NCT02336958|BG002|Baseline|Total|Total of all reporting groups
11220869|NCT02336958|FG000|Participant Flow|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
11220870|NCT02336958|FG001|Participant Flow|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
11220871|NCT02336958|OG000|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
11220872|NCT02336958|OG001|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
11220873|NCT02336958|EG000|Reported Event|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
11220874|NCT02336958|EG001|Reported Event|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
11220875|NCT02337062|BG000|Baseline|APD421 + Standard Anti-emetic|"Single dose of IV APD421~APD421"
10852748|NCT00314132|FG001|Participant Flow|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
10852749|NCT00314132|OG000|Outcome|Placebo|All subjects received a single injection of placebo on Day 0.
10852750|NCT00314132|OG001|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
10852751|NCT00314132|OG000|Outcome|Placebo|Participants received a single injection of placebo on Day 0.
10852752|NCT00314132|OG001|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
10852753|NCT00314132|EG000|Reported Event|Placebo|Participants received a single injection of placebo on Day 0.
10852754|NCT00314132|EG001|Reported Event|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
10852755|NCT00314145|BG000|Baseline|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
10852756|NCT00314145|BG001|Baseline|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
10852757|NCT00314145|BG002|Baseline|Total|Total of all reporting groups
10852758|NCT00314145|FG000|Participant Flow|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
10852759|NCT00314145|FG001|Participant Flow|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
10852760|NCT00314145|OG000|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
10852761|NCT00314145|OG001|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
11220876|NCT02337062|BG001|Baseline|Placebo + Standard Anti-emetic|"Single dose of IV placebo~Placebo"
11220877|NCT02337062|BG002|Baseline|Total|Total of all reporting groups
10852762|NCT00314145|OG001|Outcome|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
10852763|NCT00314145|EG000|Reported Event|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
10852764|NCT00314145|EG001|Reported Event|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
10852765|NCT00314236|BG000|Baseline|Experimental|BST-CarGel applied to a Microfractured lesion
10852766|NCT00314236|BG001|Baseline|Control|Microfracture alone
10852767|NCT00314236|BG002|Baseline|Total|Total of all reporting groups
11220878|NCT02337062|FG000|Participant Flow|APD421 + Standard Anti-emetic|APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
11220879|NCT02337062|FG001|Participant Flow|Placebo + Standard Anti-emetic|Matching Placebo administered as a single, slow push, IV push over one minute at the time of induction anaesthesia given in combination with standard anti-emetic
11220880|NCT02337062|OG000|Outcome|APD421 5mg + Standard Anti-emetic|APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
11220881|NCT02337062|OG001|Outcome|Placebo + Standard Anti-emetic|Matching placebo administered as a single, slow, IV push over one minute, at the time of induction of anaesthesia; given in combination with standard anti-emetic
11220882|NCT02337062|OG000|Outcome|APD421 5mg + Standard Anti-emetic|Single IV dose of 5 mg APD421 administered in combination with standard anti-emetic
11220883|NCT02337062|OG001|Outcome|Placebo + Standard Anti-emetic|Single dose of IV placebo administered in combination with standard anti-emetic
11220884|NCT02337062|EG000|Reported Event|APD421 + Standard Anti-emetic|"Single dose of IV APD421~APD421"
10852768|NCT00314236|FG000|Participant Flow|Experimental|BST-CarGel applied to a Microfractured lesion
10852769|NCT00314236|FG001|Participant Flow|Control|Microfracture alone
10852770|NCT00314236|OG000|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
10852771|NCT00314236|OG001|Outcome|Control|Microfracture alone
10852772|NCT00314236|EG000|Reported Event|Experimental|BST-CarGel applied to a Microfractured lesion
10852773|NCT00314236|EG001|Reported Event|Control|Microfracture alone
10852774|NCT00314249|BG000|Baseline|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
10852775|NCT00314249|BG001|Baseline|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
10852776|NCT00314249|BG002|Baseline|Total|Total of all reporting groups
10852777|NCT00314249|FG000|Participant Flow|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
10852778|NCT00314249|FG001|Participant Flow|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
10852779|NCT00314249|OG000|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
10852780|NCT00314249|OG001|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
10852781|NCT00314249|EG000|Reported Event|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
10852782|NCT00314249|EG001|Reported Event|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
10852783|NCT00314262|BG000|Baseline|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
10852784|NCT00314262|FG000|Participant Flow|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
10852785|NCT00314262|OG000|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
10852786|NCT00314262|EG000|Reported Event|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
10852787|NCT00314340|BG000|Baseline|Prescription Opioid Abusers|"The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and want more pain medication. Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:on cloud 9, high, good drug effect, bad drug effect, impaired,stoned, sedated, confused, nauseated from, anxious, and down. The rating levels over a six hour period were examined to explore the timing of these effects."
10852788|NCT00314340|FG000|Participant Flow|All Participants|All participants were randomized to receive the ER morphine tablets, 45 mg, hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg, or placebo in a 3 way cross over design.
10852789|NCT00314340|OG000|Outcome|ER Morphine Tablets, 45mg|Scores of the 5 Addiction Research Center Inventory dimensions did not change significantly between baseline and 300 min under any treatment condition.
11220885|NCT02337062|EG001|Reported Event|Placebo + Standard Anti-emetic|"Single dose of IV placebo~Placebo"
10852790|NCT00314340|OG001|Outcome|Hydrocodone 30 mg Plus N-acetyl-para-aminophenol 975 mg|These findings all argue against the hypothesis that the hydrocodone product induced a greater euphoric or reinforcing effect than that of ER morphine.
10852791|NCT00314340|OG002|Outcome|Placebo|
10852792|NCT00314340|EG000|Reported Event|Prescription Opioid Abusers|"The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and want more pain medication. Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:on cloud 9, high, good drug effect, bad drug effect, impaired,stoned, sedated, confused, nauseated from, anxious, and down. The rating levels over a six hour period were examined to explore the timing of these effects."
10852793|NCT00314574|BG000|Baseline|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
10852794|NCT00314574|BG001|Baseline|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
10852795|NCT00314574|BG002|Baseline|Total|Total of all reporting groups
10852796|NCT00314574|FG000|Participant Flow|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
10852797|NCT00314574|FG001|Participant Flow|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
10852798|NCT00314574|OG000|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
10852799|NCT00314574|OG001|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
10852800|NCT00314574|EG000|Reported Event|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
10852801|NCT00314574|EG001|Reported Event|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
10852802|NCT00314795|BG000|Baseline|Peginesatide|"Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months.~Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL."
10852803|NCT00314795|FG000|Participant Flow|Peginesatide|"Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months.~Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL."
10852804|NCT00314795|OG000|Outcome|Peginesatide|"Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months.~Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL."
10852805|NCT00314795|EG000|Reported Event|Peginesatide|"Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months.~Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL."
10852806|NCT00314808|BG000|Baseline|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
11220886|NCT02337218|BG000|Baseline|SENSUS Pain Management System|"Electrical stimulation device worn on the leg delivering a dose of 50 volts.~SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA."
11220887|NCT02337218|BG001|Baseline|SENSUS Pain Management System - Sham|"Electrical stimulation device worn on the leg and programmed to deliver no stimulation.~SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA."
11220888|NCT02337218|BG002|Baseline|Total|Total of all reporting groups
11220889|NCT02337218|FG000|Participant Flow|SENSUS Pain Management System|"Electrical stimulation device worn on the leg delivering a dose of 50 volts.~SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA."
11220890|NCT02337218|FG001|Participant Flow|SENSUS Pain Management System - Sham|"Electrical stimulation device worn on the leg and programmed to deliver no stimulation.~SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA."
11220891|NCT02337218|OG000|Outcome|SENSUS Pain Management System|"Electrical stimulation device worn on the leg delivering a dose of 50 volts.~SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA."
11220892|NCT02337218|OG001|Outcome|SENSUS Pain Management System - Sham|"Electrical stimulation device worn on the leg and programmed to deliver no stimulation.~SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA."
11220893|NCT02337218|EG000|Reported Event|SENSUS Pain Management System|"Electrical stimulation device worn on the leg delivering a dose of 50 volts.~SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA."
11220894|NCT02337218|EG001|Reported Event|SENSUS Pain Management System - Sham|"Electrical stimulation device worn on the leg and programmed to deliver no stimulation.~SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA."
11220895|NCT02337361|BG000|Baseline|e-SBI|"Single session, Electronic SBI for risky alcohol use~Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:~1) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."
11220896|NCT02337361|BG001|Baseline|Control|Treatment as usual with only assessment
11220897|NCT02337361|BG002|Baseline|Total|Total of all reporting groups
11220898|NCT02337361|FG000|Participant Flow|e-SBI|"Single session, Electronic Screening and Brief Intervention (SBI) for risky alcohol use~Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:~1) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."
11220899|NCT02337361|FG001|Participant Flow|Control|Treatment as usual with only assessment
11220900|NCT02337361|OG000|Outcome|e-SBI|"Single session, Electronic SBI for risky alcohol use~Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:~1) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."
11220901|NCT02337361|OG001|Outcome|Control|Treatment as usual with only assessment
11220902|NCT02337361|OG001|Outcome|Control|Treatment as usual, No intervention
10852807|NCT00314808|FG000|Participant Flow|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
10852808|NCT00314808|OG000|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
11220903|NCT02337361|EG000|Reported Event|e-SBI|"Single session, Electronic SBI for risky alcohol use~Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:~1) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."
11220904|NCT02337361|EG001|Reported Event|Control|Treatment as usual with only assessment
11220905|NCT02337387|BG000|Baseline|Blosozumab Formulation A|Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220906|NCT02337387|BG001|Baseline|Blosozumab Formulation B|Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220907|NCT02337387|BG002|Baseline|Placebo Formulation A|Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220908|NCT02337387|BG003|Baseline|Placebo Formulation B|Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220909|NCT02337387|BG004|Baseline|Total|Total of all reporting groups
10852809|NCT00314808|EG000|Reported Event|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
10852810|NCT00314951|BG000|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
10852811|NCT00314951|BG001|Baseline|Fidaxomicin|200 mg administered twice daily (q12hr)
10852812|NCT00314951|BG002|Baseline|Total|Total of all reporting groups
10852813|NCT00314951|FG000|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
10852814|NCT00314951|FG001|Participant Flow|Fidaxomicin|200 mg administered twice daily (q12hr)
10852815|NCT00314951|OG000|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
10852816|NCT00314951|OG001|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
10852817|NCT00314951|EG000|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
10852818|NCT00314951|EG001|Reported Event|Fidaxomicin|200 mg administered twice daily (q12hr)
10852819|NCT00315055|BG000|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10975788|NCT00937521|OG001|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
10852820|NCT00315055|BG001|Baseline|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852821|NCT00315055|BG002|Baseline|Total|Total of all reporting groups
10852822|NCT00315055|FG000|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852823|NCT00315055|FG001|Participant Flow|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852824|NCT00315055|OG000|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852825|NCT00315055|OG001|Outcome|PENTAXIM™ and ENGERIX® PEDIATRIC|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852826|NCT00315055|OG001|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852827|NCT00315055|OG000|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852828|NCT00315055|OG001|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852829|NCT00315055|EG000|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852830|NCT00315055|EG001|Reported Event|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
10852831|NCT00315120|BG000|Baseline|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
10852832|NCT00315120|BG001|Baseline|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
10852833|NCT00315120|BG002|Baseline|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
10852834|NCT00315120|BG003|Baseline|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
10852835|NCT00315120|BG004|Baseline|Total|Total of all reporting groups
10852836|NCT00315120|FG000|Participant Flow|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
10852837|NCT00315120|FG001|Participant Flow|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
10852838|NCT00315120|FG002|Participant Flow|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
10852839|NCT00315120|FG003|Participant Flow|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
10852840|NCT00315120|OG000|Outcome|Active OMT|Active osteopathic manipulation
10852841|NCT00315120|OG001|Outcome|Sham OMT|Sham osteopathic manipulation
10852842|NCT00315120|OG000|Outcome|Active UST|Active ultrasound physical therapy
10852843|NCT00315120|OG001|Outcome|Sham UST|Sham ultrasound physical therapy
10852844|NCT00315120|OG000|Outcome|Active UST|Active ultrasound therapy
10852845|NCT00315120|OG001|Outcome|Sham UST|Sham ultrasound therapy
10852846|NCT00315120|EG000|Reported Event|OMT + UST|Active osteopathic manipulation and active ultrasound therapy
10852847|NCT00315120|EG001|Reported Event|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound therapy
10852848|NCT00315120|EG002|Reported Event|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound therapy
10852849|NCT00315120|EG003|Reported Event|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound therapy
10852850|NCT00315146|BG000|Baseline|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
10852851|NCT00315146|BG001|Baseline|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
10852852|NCT00315146|BG002|Baseline|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
10852853|NCT00315146|BG003|Baseline|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
10852854|NCT00315146|BG004|Baseline|Total|Total of all reporting groups
10852855|NCT00315146|FG000|Participant Flow|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
10852856|NCT00315146|FG001|Participant Flow|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
10852857|NCT00315146|FG002|Participant Flow|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
10878808|NCT00454324|FG000|Participant Flow|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of Area Under the Curve (AUC)=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
11220910|NCT02337387|FG000|Participant Flow|Blosozumab Formulation A|Part A - Blosozumab Formulation A administered as a 180 milligram (mg) loading dose subcutaneously (SC) in Week 1 followed by 90 mg SC once weekly (QW) for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220911|NCT02337387|FG001|Participant Flow|Blosozumab Formulation B|Part A - Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220912|NCT02337387|FG002|Participant Flow|Placebo Formulation A|Part A - Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220913|NCT02337387|FG003|Participant Flow|Placebo Formulation B|Part A - Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220914|NCT02337387|OG000|Outcome|Blosozumab Formulation A|Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220915|NCT02337387|OG001|Outcome|Blosozumab Formulation B|Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220916|NCT02337387|OG002|Outcome|Placebo Formulation A|Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220917|NCT02337387|OG003|Outcome|Placebo Formulation B|Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220918|NCT02337387|EG000|Reported Event|Blosozumab Formulation A|Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11343054|NCT03722576|FG000|Participant Flow|Vidofludimus Calcium (VC)|"Daily dosing of Vidofludimus Calcium (VC) over 6 months~Vidofludimus calcium: During the 6-month treatment period, subjects received 30 mg VC orally once daily. This was preceded by a lead-in dosing period where subjects received 15 mg VC once daily for 1 week."
11343055|NCT03722576|OG000|Outcome|Vidofludimus Calcium (VC)|"Daily dosing of VC over 6 months~Vidofludimus calcium: During the 6-month treatment period, subjects received 30 mg VC orally once daily. This was preceded by a lead-in dosing period where subjects received 15 mg VC once daily for 1 week."
11343056|NCT03722576|EG000|Reported Event|Vidofludimus Calcium (VC)|"Daily dosing of VC over 6 months~Vidofludimus calcium: During the 6-month treatment period, subjects received 30 mg VC orally once daily. This was preceded by a lead-in dosing period where subjects received 15 mg VC once daily for 1 week."
11343057|NCT03722784|BG000|Baseline|Invigor A (Test)|"Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) and Invigor B (control) for one month of daily wear during the study.~Invigor A (test): silicone hydrogel lens"
11343058|NCT03722784|BG001|Baseline|Invigor B (Control)|"Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) and Invigor B (control) for one month of daily wear during the study.~Invigor B (Control): silicone hydrogel lens"
11343059|NCT03722784|BG002|Baseline|Total|Total of all reporting groups
11343060|NCT03722784|FG000|Participant Flow|Invigor A (Test)|"Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor A (test) for one month of daily wear during the study.~Invigor A (test): silicone hydrogel lens"
11343061|NCT03722784|FG001|Participant Flow|Invigor B (Control)|"Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor B (Control) for one month of daily wear during the study.~Invigor B (control): silicone hydrogel lens"
11343062|NCT03722784|OG000|Outcome|Invigor A (Test)|"Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.~Invigor A (test): silicone hydrogel lens"
11343063|NCT03722784|OG001|Outcome|Invigor B (Control)|"Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.~Invigor B (control): silicone hydrogel lens"
11343064|NCT03722784|OG000|Outcome|Invigor A (Test)|"Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study.~Invigor A (test): silicone hydrogel lens"
11343065|NCT03722784|EG000|Reported Event|Invigor A (Test)|"Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study.~Invigor A (test): silicone hydrogel lens"
11343066|NCT03722784|EG001|Reported Event|Invigor B (Control)|"Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study.~Invigor B (control): silicone hydrogel lens"
11343067|NCT03723915|BG000|Baseline|Pembrolizumab 200 mg IV + Pelareorep 4.5x10^10 TCID_50|"Pembrolizumab will be administered on Day 1 of each cycle at 200 mg IV over 30 minutes.~In Cycle 1, Pelareorep will be administered at a dose of 4.5x10 ^10 TCID_50 over 60 minutes on Days 1, 2, 3 and 8. From Cycle 2 onwards, Pelareorep will be administered at a dose of 4.5x10^10 TCID_50 on Days 1 and 8.~Pelareorep will be administered after completion of Pembrolizumab infusion on Day 1 of each cycle.~Each cycle is 21 days (3 weeks). Up to 32 cycles of pembrolizumab and 24 months of Pelareorep (2 years) can be administered in the absence of progression, intolerable toxicity, and other discontinuation criteria (See protocol section 4.6)."
11343068|NCT03723915|FG000|Participant Flow|Pembrolizumab 200 mg IV + Pelareorep 4.5x10^10 TCID_50|"Pembrolizumab will be administered on Day 1 of each cycle at 200 mg IV over 30 minutes.~In Cycle 1, Pelareorep will be administered at a dose of 4.5x10 ^10 TCID_50 (Tissue Culture Infective Dose 50) over 60 minutes on Days 1, 2, 3 and 8. From Cycle 2 onwards, Pelareorep will be administered at a dose of 4.5x10^10 TCID_50 on Days 1 and 8.~Pelareorep will be administered after completion of Pembrolizumab infusion on Day 1 of each cycle.~Each cycle is 21 days (3 weeks). Up to 32 cycles of pembrolizumab and 24 months of Pelareorep (2 years) can be administered in the absence of progression, intolerable toxicity, and other discontinuation criteria (See protocol section 4.6)."
10845297|NCT00266279|EG000|Reported Event|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
10852858|NCT00315146|FG003|Participant Flow|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
10852859|NCT00315146|OG000|Outcome|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
10852860|NCT00315146|OG001|Outcome|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
10852861|NCT00315146|OG002|Outcome|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
10852862|NCT00315146|OG003|Outcome|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
10852863|NCT00315146|OG000|Outcome|Hypocaloric Diet (and Placebo)|"Hypocaloric diet~Placebo"
10852864|NCT00315146|OG001|Outcome|Hypocaloric Diet, Resist. Training to Maximize Power, Placebo|"Resistance exercise training to maximize muscle power~Hypocaloric diet~Placebo"
10852865|NCT00315146|OG002|Outcome|Hypocaloric Diet and a PPAR- γ Agonist (Pioglitazone/Actos™)|"Pioglitazone~Hypocaloric diet"
10852866|NCT00315146|OG003|Outcome|Hypocaloric Diet,Resistance Training, Pioglitazone/Actos™|"Pioglitazone~Resistance exercise training to maximize muscle power~Hypocaloric diet"
10852867|NCT00315146|EG000|Reported Event|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
10852868|NCT00315146|EG001|Reported Event|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
10878809|NCT00454324|FG001|Participant Flow|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
11220919|NCT02337387|EG001|Reported Event|Blosozumab Formulation B|Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220920|NCT02337387|EG002|Reported Event|Placebo Formulation A|Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220921|NCT02337387|EG003|Reported Event|Placebo Formulation B|Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
11220922|NCT02337465|BG000|Baseline|Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy)|"Patients undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Patients also undergo kilo-voltage Cone-Beam Computed Tomography prior to radiation therapy.~Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography~3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy"
11220923|NCT02337465|FG000|Participant Flow|Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy)|"Patients undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Patients also undergo kilo-voltage Cone-Beam Computed Tomography prior to radiation therapy.~Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography~3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy"
11220924|NCT02337465|OG000|Outcome|Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy)|"Participants undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Participants also undergo kilo-voltage Cone-Beam Computed Tomography prior to radiation therapy.~Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography~3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy"
11220925|NCT02337465|EG000|Reported Event|Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy)|"Patients undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Patients also undergo kilo-voltage Cone-Beam Computed Tomography prior to radiation therapy.~Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography~3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy"
11220926|NCT02337478|BG000|Baseline|Treatment (Vincristine Sulfate Liposome)|"Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Vincristine Sulfate Liposome: Given via injection~Laboratory Biomarker Analysis: Correlative studies"
11343069|NCT03723915|OG000|Outcome|Pembrolizumab 200 mg IV + Pelareorep 4.5x10^10 TCID_50|"Pembrolizumab will be administered on Day 1 of each cycle at 200 mg IV over 30 minutes.~In Cycle 1, Pelareorep will be administered at a dose of 4.5x10 ^10 TCID_50 over 60 minutes on Days 1, 2, 3 and 8. From Cycle 2 onwards, Pelareorep will be administered at a dose of 4.5x10^10 TCID_50 on Days 1 and 8.~Pelareorep will be administered after completion of Pembrolizumab infusion on Day 1 of each cycle.~Each cycle is 21 days (3 weeks). Up to 32 cycles of pembrolizumab and 24 months of Pelareorep (2 years) can be administered in the absence of progression, intolerable toxicity, and other discontinuation criteria (See protocol section 4.6)."
11343070|NCT03723915|EG000|Reported Event|Pembrolizumab 200 mg IV + Pelareorep 4.5x10^10 TCID_50|"Pembrolizumab will be administered on Day 1 of each cycle at 200 mg IV over 30 minutes.~In Cycle 1, Pelareorep will be administered at a dose of 4.5x10 ^10 TCID_50 over 60 minutes on Days 1, 2, 3 and 8. From Cycle 2 onwards, Pelareorep will be administered at a dose of 4.5x10^10 TCID_50 on Days 1 and 8.~Pelareorep will be administered after completion of Pembrolizumab infusion on Day 1 of each cycle.~Each cycle is 21 days (3 weeks). Up to 32 cycles of pembrolizumab and 24 months of Pelareorep (2 years) can be administered in the absence of progression, intolerable toxicity, and other discontinuation criteria (See protocol section 4.6)."
11343071|NCT03724812|BG000|Baseline|Portico Valve and FlexNav™ Delivery System|Subjects will undergo an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and next-generation FlexNav Delivery system via a transfemoral access approach
11343072|NCT03724812|FG000|Participant Flow|Portico Valve and FlexNav™ Delivery System|Subjects will undergo an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and next-generation FlexNav Delivery system via a transfemoral access approach
11343073|NCT03724812|OG000|Outcome|Portico Valve and FlexNav™ Delivery System|Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
11343074|NCT03724812|OG000|Outcome|Portico Valve and FlexNav™ Delivery System|Subjects without a permanent pacemaker at baseline that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
11343075|NCT03724812|EG000|Reported Event|Portico Valve and FlexNav™ Delivery System|Subjects that underwent an attempted transcatheter aortic valve replacement (TAVR) with the Portico valve and FlexNav Delivery system via a transfemoral access approach
11343076|NCT03725982|BG000|Baseline|With Exoskeleton, Then Without Exoskeleton|Subject first performed the conditions (simulated, simplified, industrial standing work) with the exoskeleton, then without the exoskeleton.
11343077|NCT03725982|BG001|Baseline|Without Exoskeleton, Then With Exoskeleton|Subject first performed the conditions (simulated, simplified, industrial standing work) without the exoskeleton, then with the exoskeleton.
11343078|NCT03725982|BG002|Baseline|Total|Total of all reporting groups
11343079|NCT03725982|FG000|Participant Flow|First With Exoskeleton Then Without Exoskeleton|"Subject will perform the conditions (simulated, simplified, industrial standing work) as described under model description first with and then without the exoskeleton."
11343080|NCT03725982|FG001|Participant Flow|First Without Exoskeleton Then With Exoskelton|"Subject will perform the conditions (simulated, simplified, industrial standing work) as described under model description first without and then with the exoskeleton."
11343081|NCT03725982|OG000|Outcome|With Exoskeleton, Then Without Exoskeleton|Subjects first performed the conditions (simulated, simplified, industrial standing work) with the exoskeleton, then without the exoskeleton.
10845298|NCT00266409|BG000|Baseline|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
10852869|NCT00315146|EG002|Reported Event|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
10852870|NCT00315146|EG003|Reported Event|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
10852871|NCT00315302|BG000|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
10852872|NCT00315302|BG001|Baseline|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
10852873|NCT00315302|BG002|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
10852874|NCT00315302|BG003|Baseline|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
10852875|NCT00315302|BG004|Baseline|Total|Total of all reporting groups
10852876|NCT00315302|FG000|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
10852877|NCT00315302|FG001|Participant Flow|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
10852878|NCT00315302|FG002|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
10852879|NCT00315302|FG003|Participant Flow|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
10852880|NCT00315302|OG000|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
10852881|NCT00315302|OG001|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
10852882|NCT00315302|OG002|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
10852883|NCT00315302|OG003|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
10852884|NCT00315302|EG000|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
10852885|NCT00315302|EG001|Reported Event|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
10852886|NCT00315302|EG002|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
10852887|NCT00315302|EG003|Reported Event|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
10852888|NCT00315328|BG000|Baseline|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
10852889|NCT00315328|BG001|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
10852890|NCT00315328|BG002|Baseline|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
10852891|NCT00315328|BG003|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
10852892|NCT00315328|BG004|Baseline|Total|Total of all reporting groups
10852893|NCT00315328|FG000|Participant Flow|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
10852894|NCT00315328|FG001|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
10852895|NCT00315328|FG002|Participant Flow|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
10852896|NCT00315328|FG003|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
10852897|NCT00315328|OG000|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
10852898|NCT00315328|OG001|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
10852899|NCT00315328|OG002|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
10852900|NCT00315328|OG003|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
10852901|NCT00315328|EG000|Reported Event|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
10852902|NCT00315328|EG001|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
10852903|NCT00315328|EG002|Reported Event|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
10852904|NCT00315328|EG003|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
10852905|NCT00315341|BG000|Baseline|Buprenorphine/Nx|
10852906|NCT00315341|BG001|Baseline|Methadone|
10852907|NCT00315341|BG002|Baseline|Total|Total of all reporting groups
10852908|NCT00315341|FG000|Participant Flow|Buprenorphine/Nx|Participants received medication for 24 weeks in the active phase of the study. The mean dose of buprenorphine was 22.3 mg. Blood samples for measurement of liver function were taken at baseline and at Weeks 1, 2, 4 8, 12, 16, 20, and 24 with follow-up at Week 32.
10852909|NCT00315341|FG001|Participant Flow|Methadone|The mean dose of methadone was 93.2 mg.
10852910|NCT00315341|OG000|Outcome|Buprenorphine/Nx|
10852911|NCT00315341|OG001|Outcome|Methadone|
10852912|NCT00315341|EG000|Reported Event|Buprenorphine/Nx|For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
10852913|NCT00315341|EG001|Reported Event|Methadone|For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
10852914|NCT00315445|BG000|Baseline|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
10852915|NCT00315445|BG001|Baseline|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
10852916|NCT00315445|BG002|Baseline|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
10852917|NCT00315445|BG003|Baseline|Total|Total of all reporting groups
10852918|NCT00315445|FG000|Participant Flow|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
10852919|NCT00315445|FG001|Participant Flow|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
10852920|NCT00315445|FG002|Participant Flow|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
10852921|NCT00315445|OG000|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
10852922|NCT00315445|OG001|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
10852923|NCT00315445|OG002|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
10852924|NCT00315445|EG000|Reported Event|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
10852925|NCT00315445|EG001|Reported Event|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
10852926|NCT00315445|EG002|Reported Event|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
10852927|NCT00315458|BG000|Baseline|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
10852928|NCT00315458|BG001|Baseline|Double-blind BTDS|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
10852929|NCT00315458|BG002|Baseline|Total|Total of all reporting groups
10852930|NCT00315458|FG000|Participant Flow|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
10852931|NCT00315458|FG001|Participant Flow|Double-blind BTDS 10/20|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
10852932|NCT00315458|FG002|Participant Flow|Run-in Period BTDS 5/10/20|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
10852933|NCT00315458|FG003|Participant Flow|Extension Phase BTDS 5/10/20|Subjects who finished the entire 12-week (84-day) double-blind phase were eligible to participate in the open-label extension phase. Subjects began treatment with BTDS 5 and their doses were titrated to BTDS 10 or BTDS 20 as needed.
10852934|NCT00315458|OG000|Outcome|Double-blind Placebo|Reference treatment placebo 10 or 20 applied for 7-day wear
10852935|NCT00315458|OG001|Outcome|Double-blind BTDS|Test treatment buprenoprhine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
10852936|NCT00315458|OG002|Outcome|Run-in Period|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
10852937|NCT00315458|OG003|Outcome|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
10852938|NCT00315458|EG000|Reported Event|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
10852939|NCT00315458|EG001|Reported Event|Double-blind BTDS 10/20|Test treatment buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
10852940|NCT00315458|EG002|Reported Event|Run-in Period|Open-label Run-in period (BTDS 5, 10, or 20) applied for 7-day wear
10852941|NCT00315458|EG003|Reported Event|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
10852942|NCT00315588|BG000|Baseline|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant
10852943|NCT00315588|FG000|Participant Flow|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
10852944|NCT00315588|OG000|Outcome|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
10852945|NCT00315588|OG000|Outcome|Islet Transplantation|Islet transplantation in subjects with a previous kidney transplant.
10852946|NCT00315588|OG000|Outcome|Islet Transplantation|Islet transplantation in subjects with a previous kidney transplant
10852947|NCT00315588|EG000|Reported Event|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant
10852948|NCT00315614|BG000|Baseline|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
10852949|NCT00315614|FG000|Participant Flow|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
10852950|NCT00315614|OG000|Outcome|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
10852951|NCT00315614|OG000|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
10852952|NCT00315614|EG000|Reported Event|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
10852953|NCT00315627|BG000|Baseline|Islet Transplantation|Islet transplantation: Islet transplantation
10852954|NCT00315627|FG000|Participant Flow|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
10852955|NCT00315627|OG000|Outcome|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
10852956|NCT00315627|OG000|Outcome|Islet Transplantation|Islet Alone Transplantation under Alentuzumab (Campath1H) induction.
10852957|NCT00315627|OG000|Outcome|Islet Transplantation|"Islet Alone Transplantation under Alentuzumab (Campath1H) induction.~Islet transplantation: Islet transplantation"
10852958|NCT00315627|EG000|Reported Event|Islet Transplantation|Islet transplantation alone under alentuzumab (Campath1H) induction.
10852959|NCT00315705|BG000|Baseline|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
10852960|NCT00315705|BG001|Baseline|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
10852961|NCT00315705|BG002|Baseline|Total|Total of all reporting groups
10852962|NCT00315705|FG000|Participant Flow|Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.> Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
10852963|NCT00315705|OG000|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
10852964|NCT00315705|OG001|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
10852965|NCT00315705|OG002|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
10852966|NCT00315705|OG003|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
10852967|NCT00315705|OG004|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
10852968|NCT00315705|OG000|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
10852969|NCT00315705|OG000|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
10852970|NCT00315705|OG000|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
10852971|NCT00315705|EG000|Reported Event|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
10852972|NCT00315705|EG001|Reported Event|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
10852973|NCT00315705|EG002|Reported Event|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
10852974|NCT00315705|EG003|Reported Event|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
11220927|NCT02337478|FG000|Participant Flow|Treatment (Vincristine Sulfate Liposome)|"Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Vincristine Sulfate Liposome: Given via injection~Laboratory Biomarker Analysis: Correlative studies"
11220928|NCT02337478|OG000|Outcome|Treatment (Vincristine Sulfate Liposome)|"Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Vincristine Sulfate Liposome: Given via injection~Laboratory Biomarker Analysis: Correlative studies"
11220929|NCT02337478|EG000|Reported Event|Treatment (Vincristine Sulfate Liposome)|"Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Vincristine Sulfate Liposome: Given via injection~Laboratory Biomarker Analysis: Correlative studies"
11220930|NCT02337491|BG000|Baseline|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
11220931|NCT02337491|BG001|Baseline|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
11220932|NCT02337491|BG002|Baseline|Total|Total of all reporting groups
11220933|NCT02337491|FG000|Participant Flow|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
11220934|NCT02337491|FG001|Participant Flow|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
11220935|NCT02337491|OG000|Outcome|Cohort A Safety Lead-In: Pembrolizumab (DL 0) + Bevacizumab|"Pembrolizumab (Dose Level 0): 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
11220936|NCT02337491|OG000|Outcome|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
11220937|NCT02337491|OG001|Outcome|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
11220938|NCT02337491|EG000|Reported Event|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
10852975|NCT00315705|EG004|Reported Event|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
10852976|NCT00315705|EG005|Reported Event|Phase 1 - Total|All participants from Cohorts 1-5 in Phase 1
11220939|NCT02337491|EG001|Reported Event|Cohort B: Pembrolizumab|"Pembrolizumab (Dose Level 0): 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
11220940|NCT02337517|BG000|Baseline|Supportive Care (Vismodegib)|Patients receive vismodegib PO daily, every other day, every three days, or twice weekly for 6-12 months in the absence of disease progression or unacceptable toxicity.
11220941|NCT02337517|FG000|Participant Flow|Supportive Care (Vismodegib)|Patients receive vismodegib PO daily, every other day, every three days, or twice weekly for 6-12 months in the absence of disease progression or unacceptable toxicity.
11220942|NCT02337517|OG000|Outcome|Supportive Care (Vismodegib)|Patients receive vismodegib PO daily, every other day, every three days, or twice weekly for 6-12 months in the absence of disease progression or unacceptable toxicity.
11220943|NCT02337517|EG000|Reported Event|Supportive Care (Vismodegib)|Patients receive vismodegib PO daily, every other day, every three days, or twice weekly for 6-12 months in the absence of disease progression or unacceptable toxicity.
10852977|NCT00315705|EG006|Reported Event|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
11220944|NCT02337530|BG000|Baseline|Intermittent Oral Selumatinib With Pemetrexed and Platinum|"Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m^2 & Cisplatin or Carboplatin*: AUC6: 75mg/m^2 given on day 1 Schedule = q 21 days~*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Selumetinib~Pemetrexed~Cisplatin~Carboplatin"
11220945|NCT02337530|BG001|Baseline|Continuous Oral Selumatinib With Pemetrexed and Platinum|"Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m^2 & Cisplatin*: 75mg/m^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days~**Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Selumetinib~Pemetrexed~Cisplatin~Carboplatin"
11220946|NCT02337530|BG002|Baseline|Pemetrexed and Platinum Alone|"Selumetinib: NOT GIVEN Pemetrexed: 500mg/m^2 & Cisplatin*: 75mg/m^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days~*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Pemetrexed~Cisplatin~Carboplatin"
11220947|NCT02337530|BG003|Baseline|Total|Total of all reporting groups
11343082|NCT03725982|OG001|Outcome|Without Exoskeleton, Then With Exoskeleton|Subjects first performed the conditions (simulated, simplified, industrial standing work) without the exoskeleton, then with the exoskeleton.
10852978|NCT00315731|BG000|Baseline|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10852979|NCT00315731|FG000|Participant Flow|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10852980|NCT00315731|OG000|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10852981|NCT00315731|OG001|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10852982|NCT00315731|OG001|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10852983|NCT00315731|EG000|Reported Event|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10852984|NCT00315822|BG000|Baseline|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
10852985|NCT00315822|BG001|Baseline|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
10852986|NCT00315822|BG002|Baseline|Total|Total of all reporting groups
10852987|NCT00315822|FG000|Participant Flow|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
10852988|NCT00315822|FG001|Participant Flow|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
10852989|NCT00315822|OG000|Outcome|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
10852990|NCT00315822|OG001|Outcome|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
10852991|NCT00315822|EG000|Reported Event|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
10852992|NCT00315822|EG001|Reported Event|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
11098801|NCT01578031|OG001|Outcome|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
11098802|NCT01578031|EG000|Reported Event|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
11343083|NCT03725982|OG000|Outcome|Without Exoskeleton|Subjects performed the condition without the exoskeleton.
11343084|NCT03725982|OG001|Outcome|With Exoskeleton|Subjects performed the condition without the exoskeleton.
10852993|NCT00315939|BG000|Baseline|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months.
10852994|NCT00315939|BG001|Baseline|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months.
10852995|NCT00315939|BG002|Baseline|Total|Total of all reporting groups
10852996|NCT00315939|FG000|Participant Flow|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
11220948|NCT02337530|FG000|Participant Flow|Intermittent Oral Selumatinib With Pemetrexed and Platinum|"Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m^2 & Cisplatin or Carboplatin*: AUC6: 75mg/m^2 given on day 1 Schedule = q 21 days~*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Selumetinib~Pemetrexed~Cisplatin~Carboplatin"
11220949|NCT02337530|FG001|Participant Flow|Continuous Oral Selumatinib With Pemetrexed and Platinum|"Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m^2 & Cisplatin*: 75mg/m^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days~**Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Selumetinib~Pemetrexed~Cisplatin~Carboplatin"
11220950|NCT02337530|FG002|Participant Flow|Pemetrexed and Platinum Alone|"Selumetinib: NOT GIVEN Pemetrexed: 500mg/m^2 & Cisplatin*: 75mg/m^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days~*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Pemetrexed~Cisplatin~Carboplatin"
11220951|NCT02337530|OG000|Outcome|Intermittent Oral Selumatinib With Pemetrexed and Platinum|"Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m^2 & Cisplatin or Carboplatin*: AUC6: 75mg/m^2 given on day 1 Schedule = q 21 days~*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Selumetinib~Pemetrexed~Cisplatin~Carboplatin"
11220952|NCT02337530|OG001|Outcome|Continuous Oral Selumatinib With Pemetrexed and Platinum|"Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m^2 & Cisplatin*: 75mg/m^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days~**Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Selumetinib~Pemetrexed~Cisplatin~Carboplatin"
11220953|NCT02337530|OG002|Outcome|Pemetrexed and Platinum Alone|"Selumetinib: NOT GIVEN Pemetrexed: 500mg/m^2 & Cisplatin*: 75mg/m^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days~*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Pemetrexed~Cisplatin~Carboplatin"
11220954|NCT02337530|EG000|Reported Event|Intermittent Oral Selumatinib With Pemetrexed and Platinum|"Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m^2 & Cisplatin or Carboplatin*: AUC6: 75mg/m^2 given on day 1 Schedule = q 21 days~*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Selumetinib~Pemetrexed~Cisplatin~Carboplatin"
11220955|NCT02337530|EG001|Reported Event|Continuous Oral Selumatinib With Pemetrexed and Platinum|"Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m^2 & Cisplatin*: 75mg/m^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days~**Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Selumetinib~Pemetrexed~Cisplatin~Carboplatin"
11220956|NCT02337530|EG002|Reported Event|Pemetrexed and Platinum Alone|"Selumetinib: NOT GIVEN Pemetrexed: 500mg/m^2 & Cisplatin*: 75mg/m^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days~*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG~Pemetrexed~Cisplatin~Carboplatin"
11220957|NCT02337907|BG000|Baseline|BI 409306 10 Milligram (mg) Once Daily (QD)|Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
10852997|NCT00315939|FG001|Participant Flow|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
11220958|NCT02337907|BG001|Baseline|BI 409306 25 mg QD|Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
11220959|NCT02337907|BG002|Baseline|BI 409306 50 mg QD|Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
11220960|NCT02337907|BG003|Baseline|BI 409306 25 mg Twice Daily (BID)|Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
10878810|NCT00454324|OG000|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
10852998|NCT00315939|OG000|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.~Each level continued for 3 months.~IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.~IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
10852999|NCT00315939|EG000|Reported Event|IBMF-1|IBMF-1 will use the OneTouch® UltraSmart® glucometer (LifeScan, Milpitas, CA) to collect routine SMBG data and the subject transfers the blood glucose (BG) value into a hand-held computer (HHC) for processing. As the subject checks BG on a daily basis, the IBMF-1 software calculates an estimate of HbA1c, acute risk for hypoglycemia and chronic risk for hypoglycemia. This information will be presented back to the subject. Specifically, (i) alarms for immediate action if BG<50 mg/dL is registered; (ii) a running HbA1c estimate (71); (iii) a warning to be more careful and measure BG more frequently over the next 24 hours if elevated acute risk for hypoglycemia is found, and (iv) an indication of the subject's chronic risk for hypoglycemia in one of 4 categories (minimal, low, moderate, and high). At moderate and high risk the subject will be prompted to consider altering his/her behavior. HbA1c and chronic risk change slowly (2-3 weeks), while acute risk can change daily.
10853000|NCT00315939|EG001|Reported Event|IBMF-2|IBMF-2 retains level 2, but the HHC asks subjects to provide symptom ratings when BG (blood glucose) is low and at an equal number of matching euglycemic readings. From these data, the HHC estimates a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
10853001|NCT00316004|BG000|Baseline|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853002|NCT00316004|BG001|Baseline|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853003|NCT00316004|BG002|Baseline|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853004|NCT00316004|BG003|Baseline|Total|Total of all reporting groups
10853005|NCT00316004|FG000|Participant Flow|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853006|NCT00316004|FG001|Participant Flow|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853007|NCT00316004|FG002|Participant Flow|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853008|NCT00316004|OG000|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853009|NCT00316004|OG001|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853010|NCT00316004|OG002|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853011|NCT00316004|EG000|Reported Event|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853012|NCT00316004|EG001|Reported Event|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853013|NCT00316004|EG002|Reported Event|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
10853014|NCT00316017|BG000|Baseline|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
10853015|NCT00316017|BG001|Baseline|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
10853016|NCT00316017|BG002|Baseline|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
10853017|NCT00316017|BG003|Baseline|Total|Total of all reporting groups
10853018|NCT00316017|FG000|Participant Flow|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
10853019|NCT00316017|FG001|Participant Flow|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
10853020|NCT00316017|FG002|Participant Flow|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
10853021|NCT00316017|OG000|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
10853022|NCT00316017|OG001|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
10853023|NCT00316017|OG002|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
10853024|NCT00316017|EG000|Reported Event|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
10853025|NCT00316017|EG001|Reported Event|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
10853026|NCT00316017|EG002|Reported Event|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
10853027|NCT00316082|BG000|Baseline|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
10853028|NCT00316082|BG001|Baseline|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
10853029|NCT00316082|BG002|Baseline|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
10853030|NCT00316082|BG003|Baseline|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
10853031|NCT00316082|BG004|Baseline|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
10853032|NCT00316082|BG005|Baseline|Total|Total of all reporting groups
10853033|NCT00316082|FG000|Participant Flow|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
10853034|NCT00316082|FG001|Participant Flow|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
10853035|NCT00316082|FG002|Participant Flow|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
10853036|NCT00316082|FG003|Participant Flow|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
10853037|NCT00316082|FG004|Participant Flow|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
10853038|NCT00316082|OG000|Outcome|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
10853039|NCT00316082|OG001|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
10853040|NCT00316082|OG002|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
10853041|NCT00316082|OG003|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
10853042|NCT00316082|OG000|Outcome|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
10853043|NCT00316082|OG001|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
10853044|NCT00316082|OG000|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
10853045|NCT00316082|OG003|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
10853046|NCT00316082|OG004|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
10853047|NCT00316082|EG000|Reported Event|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
11220961|NCT02337907|BG004|Baseline|Placebo Matching BI 409306|Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
10853048|NCT00316082|EG001|Reported Event|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
10853049|NCT00316082|EG002|Reported Event|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
10853050|NCT00316082|EG003|Reported Event|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
10853051|NCT00316082|EG004|Reported Event|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
10853052|NCT00316121|BG000|Baseline|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
10853053|NCT00316121|BG001|Baseline|Control|Autograft is bone taken from the subject's own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
10853054|NCT00316121|BG002|Baseline|Total|Total of all reporting groups
11007011|NCT01089062|BG002|Baseline|Treatment B, Then A, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
10853055|NCT00316121|FG000|Participant Flow|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
10853056|NCT00316121|FG001|Participant Flow|Control|Autograft is bone taken from the subject's own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
10853057|NCT00316121|OG000|Outcome|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
10853058|NCT00316121|OG001|Outcome|Control|Autograft is bone taken from the subject's own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
11098803|NCT01578031|EG001|Reported Event|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
11098804|NCT01578031|EG002|Reported Event|Obese Patients Without Sleep Apnea|Control Obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index < 15
11098805|NCT01578031|EG003|Reported Event|Non-obese Patients Without Sleep Apnea|Control Non-obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index < 15
11098806|NCT01578044|BG000|Baseline|Intervention Group|"Patients who are randomized to the intervention group will receive the following:~Patient education: Patients will receive information on dabigatran, apixaban, and rivaroxaban, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.~Pharmacy follow-up: If the anticoagulant has not been refilled, the pharmacy staff will contact the patient to assess reasons the patient has not refilled the medication."
11098807|NCT01578044|BG001|Baseline|Usual Care Group|"Usual care~Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.~Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
11098808|NCT01578044|BG002|Baseline|Total|Total of all reporting groups
11098809|NCT01578044|FG000|Participant Flow|Intervention Group|"Intervention patients will receive the following:~Patient education: All patients will receive information on their oral anticoagulant, including risks, benefits, and potential side effects. Intervention patients will receive additional materials at the beginning of the study through the mail.~Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
11098810|NCT01578044|FG001|Participant Flow|Usual Care|"Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.~Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
11098811|NCT01578044|OG000|Outcome|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
11098812|NCT01578044|OG001|Outcome|Usual Care Group|All usual care patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Additionally, following their time in the study, the usual care patients will receive the additional educational materials the usual care received.
11126260|NCT01784848|BG000|Baseline|Laparoscopic Roux-en-Y Gastric Bypass|"Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.~Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery~Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction."
11343085|NCT03725982|OG001|Outcome|With Exoskeleton|Subjects performed the condition with the exoskeleton.
10853059|NCT00316121|EG000|Reported Event|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
10853060|NCT00316121|EG001|Reported Event|Control|Autograft is bone taken from the subject's own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
10853061|NCT00316173|BG000|Baseline|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
10853062|NCT00316173|BG001|Baseline|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
10853063|NCT00316173|BG002|Baseline|Total|Total of all reporting groups
10853064|NCT00316173|FG000|Participant Flow|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
10853065|NCT00316173|FG001|Participant Flow|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
10853066|NCT00316173|OG000|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
10853067|NCT00316173|EG000|Reported Event|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
10853068|NCT00316173|EG001|Reported Event|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
11220962|NCT02337907|BG005|Baseline|Donepezil QD|Patients were administered orally over capsulated tablet of Donepezil once daily for 12 weeks.
10853069|NCT00316186|BG000|Baseline|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
10853070|NCT00316186|FG000|Participant Flow|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
10853071|NCT00316186|OG000|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
10853072|NCT00316186|EG000|Reported Event|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
10853073|NCT00316199|BG000|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
10853074|NCT00316199|FG000|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
10853075|NCT00316199|OG000|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
10853076|NCT00316199|EG000|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
10853077|NCT00316225|BG000|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
10853078|NCT00316225|FG000|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
10853079|NCT00316225|OG000|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
10853080|NCT00316225|EG000|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
10853081|NCT00316264|BG000|Baseline|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853082|NCT00316264|BG001|Baseline|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853083|NCT00316264|BG002|Baseline|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853084|NCT00316264|BG003|Baseline|Total|Total of all reporting groups
10853085|NCT00316264|FG000|Participant Flow|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853086|NCT00316264|FG001|Participant Flow|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853087|NCT00316264|FG002|Participant Flow|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
11220963|NCT02337907|BG006|Baseline|Total|Total of all reporting groups
10853088|NCT00316264|OG000|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853089|NCT00316264|OG001|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853090|NCT00316264|OG002|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853091|NCT00316264|EG000|Reported Event|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853092|NCT00316264|EG001|Reported Event|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853093|NCT00316264|EG002|Reported Event|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
10853094|NCT00316277|BG000|Baseline|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
10853095|NCT00316277|BG001|Baseline|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
10853096|NCT00316277|BG002|Baseline|Total|Total of all reporting groups
10853097|NCT00316277|FG000|Participant Flow|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
10853098|NCT00316277|FG001|Participant Flow|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
10853099|NCT00316277|OG000|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
11126261|NCT01784848|BG001|Baseline|Clinical Treatment|"Optimized clinical treatment including medical management of hypertension.~Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction."
10853100|NCT00316277|OG001|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
10853101|NCT00316277|OG000|Outcome|Success in Phase 1 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
10853102|NCT00316277|OG001|Outcome|Success in Phase 1 Among Participants Without Chronic Pain|
10853103|NCT00316277|OG000|Outcome|Success in Phase 2 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
10853104|NCT00316277|OG001|Outcome|Success in Phase 2 Among Participants Without Chronic Pain|
10853105|NCT00316277|OG000|Outcome|Success in Phase 1 Among Participants With Heroin Use|
10853106|NCT00316277|OG001|Outcome|Success in Phase 1 Among Participants Without Heroin Use|
10853107|NCT00316277|OG000|Outcome|Success in Phase 2 Among Participants With Heroin Use|
10853108|NCT00316277|OG001|Outcome|Success in Phase 2 Among Participants Without Heroin Use|
10853109|NCT00316277|EG000|Reported Event|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
11126262|NCT01784848|BG002|Baseline|Total|Total of all reporting groups
10853110|NCT00316277|EG001|Reported Event|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
10853111|NCT00316303|BG000|Baseline|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
10853112|NCT00316303|BG001|Baseline|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
10853113|NCT00316303|BG002|Baseline|Total|Total of all reporting groups
10853114|NCT00316303|FG000|Participant Flow|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
11220964|NCT02337907|FG000|Participant Flow|BI 409306 10 Milligram (mg) Once Daily (QD)|Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
11343086|NCT03725982|OG000|Outcome|With Exoskeleton|Subjects performed the condition with the exoskeleton.
10853115|NCT00316303|FG001|Participant Flow|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
10853116|NCT00316303|OG000|Outcome|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
10853117|NCT00316303|OG001|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
10853118|NCT00316303|OG000|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
10853119|NCT00316303|OG001|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A and hepatitis B immunizations, and any necessary treatments.
10853120|NCT00316303|OG001|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
10853121|NCT00316303|EG000|Reported Event|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
10853122|NCT00316303|EG001|Reported Event|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
11220965|NCT02337907|FG001|Participant Flow|BI 409306 25 mg QD|Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
10853123|NCT00316355|BG000|Baseline|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Traditional CBT: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
10853124|NCT00316355|BG001|Baseline|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
10853125|NCT00316355|BG002|Baseline|Total|Total of all reporting groups
10853126|NCT00316355|FG000|Participant Flow|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
10853127|NCT00316355|FG001|Participant Flow|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
10853128|NCT00316355|OG000|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
10853129|NCT00316355|OG001|Outcome|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
10853130|NCT00316355|EG000|Reported Event|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
10853131|NCT00316355|EG001|Reported Event|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
10853132|NCT00316524|BG000|Baseline|Group 1: 2x MVA-BN® s.c., Vaccinia Naive|vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
11220966|NCT02337907|FG002|Participant Flow|BI 409306 50 mg QD|Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
11220967|NCT02337907|FG003|Participant Flow|BI 409306 25 mg Twice Daily (BID)|Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
11220968|NCT02337907|FG004|Participant Flow|Placebo Matching BI 409306|Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
11220969|NCT02337907|FG005|Participant Flow|Donepezil QD|Patients were administered orally over capsulated tablet of Donepezil once daily for 12 weeks.
11220970|NCT02337907|OG000|Outcome|BI 409306 10 Milligram (mg) Once Daily (QD)|Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
10853133|NCT00316524|BG001|Baseline|Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive|vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one vaccination Placebo (0.5mL Tris Buffer)
10853134|NCT00316524|BG002|Baseline|Group 3: 2x Placebo, s.c., Vaccinia Naive|"vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)~Placebo: Tris-Buffer"
10853135|NCT00316524|BG003|Baseline|Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced|vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
10853136|NCT00316524|BG004|Baseline|Total|Total of all reporting groups
10853137|NCT00316524|FG000|Participant Flow|Group 1: 2 x MVA-BN® s.c., Vaccinia Naive|vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
10853138|NCT00316524|FG001|Participant Flow|Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive|vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one vaccination Placebo (0.5mL Tris Buffer)
10853139|NCT00316524|FG002|Participant Flow|Group 3: Two x Placebo, s.c., Vaccinia Naive|"vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer).~Placebo: Tris-Buffer"
10853140|NCT00316524|FG003|Participant Flow|Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced|vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID50).
10853141|NCT00316524|OG000|Outcome|GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive|"vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID)~MVA-BN® (IMVAMUNE): 1x 10E8_TCID50"
10853142|NCT00316524|OG001|Outcome|GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive|"vaccinia naive subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID), followed by one subcutaneous vaccination Placebo (0.5ml Tris Buffer)~MVA-BN® (IMVAMUNE): 1x 10E8_TCID50~Placebo: Tris-Buffer"
10853143|NCT00316524|OG002|Outcome|GP 3: Two x Placebo, s.c., Vaccinia Naive|"vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer)~Placebo: Tris-Buffer"
10853144|NCT00316524|OG003|Outcome|GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced|"vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID)~MVA-BN® (IMVAMUNE): 1x 10E8_TCID50"
10853145|NCT00316524|OG000|Outcome|Group 1: 2x MVA-BN® s.c., Vaccinia Naive|vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
10853146|NCT00316524|OG001|Outcome|Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive|vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)
10853147|NCT00316524|OG002|Outcome|Group 3: 2x Placebo, s.c., Vaccinia Naive|"vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)~Placebo: Tris-Buffer"
10853148|NCT00316524|OG003|Outcome|Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced|vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
10853149|NCT00316524|EG000|Reported Event|GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive|"vaccinia naive subjects receiving two subcutanenous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID)~MVA-BN® (IMVAMUNE): 1x 10E8_TCID50"
10853150|NCT00316524|EG001|Reported Event|GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive|"vaccinica naive subjects receiving one vaccination with 0.5ml MVA-BN® IMVAMUNE(1x10E08 TCID), followed by one vaccination Placebo (0.5ml Tris Buffer)~MVA-BN® (IMVAMUNE): 1x 10E8_TCID50~Placebo: Tris-Buffer"
10853151|NCT00316524|EG002|Reported Event|GP 3: Two x Placebo, s.c., Vaccinia Naive|"vaccinia naive subjects, receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer).~Placebo: Tris-Buffer"
10853152|NCT00316524|EG003|Reported Event|GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced|"vaccinia experienced subjects, receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID).~MVA-BN® (IMVAMUNE): 1x 10E8_TCID50"
10853153|NCT00316589|BG000|Baseline|Healthy naïve|Healthy, smallpox vaccine-naïve subjects
10853154|NCT00316589|BG001|Baseline|HIV naïve|HIV-infected, smallpox vaccine-naïve subjects
10853155|NCT00316589|BG002|Baseline|Healthy Experienced|Healthy, smallpox vaccine-experienced subjects
10853156|NCT00316589|BG003|Baseline|HIV Experienced|HIV-infected, smallpox vaccine-experienced subjects
10853157|NCT00316589|BG004|Baseline|Total|Total of all reporting groups
10853158|NCT00316589|FG000|Participant Flow|Healthy naïve|Healthy, smallpox vaccine-naïve subjects
10853159|NCT00316589|FG001|Participant Flow|HIV naïve|HIV-infected, smallpox vaccine-naïve subjects
10853160|NCT00316589|FG002|Participant Flow|Healthy Experienced|Healthy, smallpox vaccine-experienced subjects
10853161|NCT00316589|FG003|Participant Flow|HIV Experienced|HIV-infected, smallpox vaccine-experienced subjects
10853162|NCT00316589|OG000|Outcome|Healthy naïve|Healthy, smallpox vaccine-naïve subjects
10853163|NCT00316589|OG001|Outcome|HIV naïve|HIV-infected, smallpox vaccine-naïve subjects
10853164|NCT00316589|OG002|Outcome|Healthy Experienced|Healthy, smallpox vaccine-experienced subjects
10853165|NCT00316589|OG003|Outcome|HIV Experienced|HIV-infected, smallpox vaccine-experienced subjects
10853166|NCT00316589|OG000|Outcome|HIV naïve|HIV-infected, smallpox vaccine-naïve subjects
10853167|NCT00316589|OG001|Outcome|HIV Experienced|HIV-infected, smallpox vaccine-experienced subjects
10853168|NCT00316589|EG000|Reported Event|Healthy naïve|Healthy, smallpox vaccine-naïve subjects
10853169|NCT00316589|EG001|Reported Event|HIV naïve|HIV-infected, smallpox vaccine-naïve subjects
10853170|NCT00316589|EG002|Reported Event|Healthy Experienced|Healthy, smallpox vaccine-experienced subjects
10853171|NCT00316589|EG003|Reported Event|HIV Experienced|HIV-infected, smallpox vaccine-experienced subjects
10853172|NCT00316602|BG000|Baseline|Healthy Participants|Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
10853173|NCT00316602|BG001|Baseline|Atopic Dermatitis Participants|"Vaccinia naïve subjects with diagnosed AD. Diagnosed AD included subjects with either history of or subjects with currently active AD (defined as scoring AD [SCORAD] ≤ 30)"
10853174|NCT00316602|BG002|Baseline|Total|Total of all reporting groups
10853175|NCT00316602|FG000|Participant Flow|Healthy Participants|"Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)~IMVAMUNE: Subjects receiving two subcutaneous vaccinations"
10853176|NCT00316602|FG001|Participant Flow|Atopic Dermatitis Participants|"Vaccinia naive subjects with diagnosed Atopic Dermatitis. Diagnosed AD included subjects with either history of or subjects with currently active AD (defined as scoring AD [SCORAD] <= 30), receiving two doses of MVA-BN (IMVAMUNE)~IMVAMUNE: Subjects receiving two subcutaneous vaccinations"
10853177|NCT00316602|OG000|Outcome|Healthy Participants|Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
10853178|NCT00316602|OG001|Outcome|Atopic Dermatitis Participants|"Vaccinia naïve subjects with diagnosed AD. Diagnosed AD included subjects with either history of or subjects with currently active AD (defined as scoring AD [SCORAD] ≤ 30)"
10853179|NCT00316602|EG000|Reported Event|Healthy Participants|Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
10853180|NCT00316602|EG001|Reported Event|Atopic Dermatitis Participants|"Vaccinia naïve subjects with diagnosed AD. Diagnosed AD included subjects with either history of or subjects with currently active AD (defined as scoring AD [SCORAD] ≤ 30)"
10853181|NCT00316693|BG000|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
10853182|NCT00316693|BG001|Baseline|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
10853183|NCT00316693|BG002|Baseline|Total|Total of all reporting groups
10853184|NCT00316693|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
10853185|NCT00316693|FG001|Participant Flow|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
11220971|NCT02337907|OG001|Outcome|BI 409306 25 mg QD|Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
11007012|NCT01089062|BG003|Baseline|Treatment B, Then C, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
10853186|NCT00316693|OG000|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
10853187|NCT00316693|OG001|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
10853188|NCT00316693|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
10853189|NCT00316693|EG001|Reported Event|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
10853190|NCT00316706|BG000|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
10853191|NCT00316706|BG001|Baseline|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
10853192|NCT00316706|BG002|Baseline|Total|Total of all reporting groups
10853193|NCT00316706|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
10853194|NCT00316706|FG001|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
10853195|NCT00316706|OG000|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
10853196|NCT00316706|OG001|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
10853197|NCT00316706|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
10853198|NCT00316706|EG001|Reported Event|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
10853199|NCT00316719|BG000|Baseline|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
10853200|NCT00316719|BG001|Baseline|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
10853201|NCT00316719|BG002|Baseline|Total|Total of all reporting groups
10853202|NCT00316719|FG000|Participant Flow|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
10853203|NCT00316719|FG001|Participant Flow|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
10853204|NCT00316719|OG000|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
10853205|NCT00316719|OG001|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
10853206|NCT00316719|EG000|Reported Event|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
10853207|NCT00316719|EG001|Reported Event|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
10878811|NCT00454324|OG001|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
10878812|NCT00454324|EG000|Reported Event|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
10853208|NCT00316862|BG000|Baseline|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
10853209|NCT00316862|FG000|Participant Flow|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
10853210|NCT00316862|OG000|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
10853211|NCT00316862|EG000|Reported Event|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
10878813|NCT00454324|EG001|Reported Event|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
11220972|NCT02337907|OG002|Outcome|BI 409306 50 mg QD|Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
11343087|NCT03725982|OG001|Outcome|Without Exoskeleton|Subjects performed the condition without the exoskeleton.
10853221|NCT00316914|BG000|Baseline|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
10853222|NCT00316914|BG001|Baseline|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
10853223|NCT00316914|BG002|Baseline|Total|Total of all reporting groups
10853224|NCT00316914|FG000|Participant Flow|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
10853225|NCT00316914|FG001|Participant Flow|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
10853226|NCT00316914|OG000|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
10853227|NCT00316914|OG001|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
10853228|NCT00316914|EG000|Reported Event|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
10853229|NCT00316914|EG001|Reported Event|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
10853230|NCT00317044|BG000|Baseline|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
10853231|NCT00317044|BG001|Baseline|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
10853232|NCT00317044|BG002|Baseline|Placebo|Placebo
10853233|NCT00317044|BG003|Baseline|Total|Total of all reporting groups
10853234|NCT00317044|FG000|Participant Flow|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
10853235|NCT00317044|FG001|Participant Flow|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
10853236|NCT00317044|FG002|Participant Flow|Placebo|Placebo
10853237|NCT00317044|OG000|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
10853238|NCT00317044|OG001|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
10853239|NCT00317044|OG002|Outcome|Placebo|Placebo
10853240|NCT00317044|EG000|Reported Event|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
10853241|NCT00317044|EG001|Reported Event|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
10853242|NCT00317044|EG002|Reported Event|Placebo|Placebo
10853243|NCT00317109|BG000|Baseline|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10853244|NCT00317109|BG001|Baseline|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10853245|NCT00317109|BG002|Baseline|Total|Total of all reporting groups
10853246|NCT00317109|FG000|Participant Flow|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10853247|NCT00317109|FG001|Participant Flow|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10853248|NCT00317109|OG000|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10853249|NCT00317109|OG001|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10853250|NCT00317109|EG000|Reported Event|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10853251|NCT00317109|EG001|Reported Event|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10853252|NCT00317226|BG000|Baseline|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
10853253|NCT00317226|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
10853254|NCT00317226|OG000|Outcome|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
10853255|NCT00317226|EG000|Reported Event|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
10853256|NCT00317239|BG000|Baseline|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
10853257|NCT00317239|BG001|Baseline|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
10853258|NCT00317239|BG002|Baseline|Total|Total of all reporting groups
11220973|NCT02337907|OG003|Outcome|BI 409306 25 mg Twice Daily (BID)|Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
10853259|NCT00317239|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
10853260|NCT00317239|FG001|Participant Flow|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
10853261|NCT00317239|OG000|Outcome|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
10853262|NCT00317239|OG001|Outcome|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
10853263|NCT00317239|EG000|Reported Event|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
10853264|NCT00317239|EG001|Reported Event|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
10853265|NCT00317356|BG000|Baseline|OPC-6535 12.5 mg|12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
11220974|NCT02337907|OG004|Outcome|Pooled BI 409306|Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
10853266|NCT00317356|BG001|Baseline|OPC-6535 25 mg|25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853267|NCT00317356|BG002|Baseline|OPC-6535 50 mg|25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
10853268|NCT00317356|BG003|Baseline|Placebo|0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853269|NCT00317356|BG004|Baseline|Total|Total of all reporting groups
10853270|NCT00317356|FG000|Participant Flow|OPC-6535 12.5 mg|12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853271|NCT00317356|FG001|Participant Flow|OPC-6535 25 mg|25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853272|NCT00317356|FG002|Participant Flow|OPC-6535 50 mg|25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
11220975|NCT02337907|OG005|Outcome|Placebo Matching BI 409306|Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
11220976|NCT02337907|OG004|Outcome|Placebo Matching BI 409306|Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
11220977|NCT02337907|EG000|Reported Event|BI 409306 10 Milligram (mg) Once Daily (QD)|Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
10853273|NCT00317356|FG003|Participant Flow|Placebo|0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853274|NCT00317356|OG000|Outcome|OPC-6535 12.5 mg|12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853275|NCT00317356|OG001|Outcome|OPC-6535 25 mg|25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853276|NCT00317356|OG002|Outcome|OPC-6535 50 mg|25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
10853277|NCT00317356|OG003|Outcome|Placebo|0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853278|NCT00317356|EG000|Reported Event|OPC-6535 12.5 mg|12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853279|NCT00317356|EG001|Reported Event|OPC-6535 25 mg|25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853280|NCT00317356|EG002|Reported Event|OPC-6535 50 mg|25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
10853281|NCT00317356|EG003|Reported Event|Placebo|0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853282|NCT00317369|BG000|Baseline|OPC-6535 25 mg|25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853283|NCT00317369|BG001|Baseline|OPC-6535 50 mg|25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.
10853284|NCT00317369|BG002|Baseline|Placebo|0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853285|NCT00317369|BG003|Baseline|Total|Total of all reporting groups
10853286|NCT00317369|FG000|Participant Flow|OPC-6535 25 mg|25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853287|NCT00317369|FG001|Participant Flow|OPC-6535 50 mg|25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.
10853288|NCT00317369|FG002|Participant Flow|Placebo|0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853289|NCT00317369|OG000|Outcome|OPC-6535 25 mg|25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853290|NCT00317369|OG001|Outcome|OPC-6535 50 mg|25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.
10853291|NCT00317369|OG002|Outcome|Placebo|0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853292|NCT00317369|EG000|Reported Event|OPC-6535 25 mg|25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853293|NCT00317369|EG001|Reported Event|OPC-6535 50 mg|25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.
10853294|NCT00317369|EG002|Reported Event|Placebo|0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
10853295|NCT00317473|BG000|Baseline|FMP1/AS02A Malaria Vaccine 10ug (Cohort A)|"Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853296|NCT00317473|BG001|Baseline|Imovax (Cohort A)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
10853297|NCT00317473|BG002|Baseline|FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)|"Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853298|NCT00317473|BG003|Baseline|Imovax (Cohort B)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
10853299|NCT00317473|BG004|Baseline|FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)|"Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853300|NCT00317473|BG005|Baseline|Imovax (Cohort C)|"Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days~Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days"
10853301|NCT00317473|BG006|Baseline|Total|Total of all reporting groups
10853302|NCT00317473|FG000|Participant Flow|FMP1/AS02A Malaria Vaccine 10ug (Cohort A)|"Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853303|NCT00317473|FG001|Participant Flow|Imovax (Cohort A)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
11126263|NCT01784848|FG000|Participant Flow|Laparoscopic Roux-en-Y Gastric Bypass|"Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.~Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery~Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction."
10853304|NCT00317473|FG002|Participant Flow|FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)|"Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853305|NCT00317473|FG003|Participant Flow|Imovax (Cohort B)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
10853306|NCT00317473|FG004|Participant Flow|FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)|"Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853307|NCT00317473|FG005|Participant Flow|Imovax (Cohort C)|"Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days~Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days"
10853308|NCT00317473|OG000|Outcome|FMP1/AS02A Malaria Vaccine|Subject vaccinated with FMP1/AS02A (cohorts A, B, and C)
10853309|NCT00317473|OG001|Outcome|Imovax Rabies Vaccine|Subject vaccinated with Imovax Rabies Vaccine (cohorts A, B, and C)
10853310|NCT00317473|OG002|Outcome|Overall|Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine (cohorts A, B, and C)
10853311|NCT00317473|OG000|Outcome|FMP1/AS02A Imm 1|Subjects 1st vaccination with FMP1/AS02A
10853312|NCT00317473|OG001|Outcome|FMP1/AS02A Imm 2|Subjects 2nd vaccination with FMP1/AS02A
10853313|NCT00317473|OG002|Outcome|FMP1/AS02A Imm 3|Subjects 3rd vaccination with FMP1/AS02A
10853314|NCT00317473|OG003|Outcome|FMP1/AS02A Any Imm|Subjects vaccinated within all immunization cycles
10853315|NCT00317473|OG004|Outcome|Imovax Imm 1|Subjects 1st vaccination with Imovax Rabies Vaccine
10853316|NCT00317473|OG005|Outcome|Imovax Imm 2|Subjects 2nd vaccination with Imovax Rabies Vaccine
10853317|NCT00317473|OG006|Outcome|Imovax Imm 3|Subjects 3rd vaccination with Imovax Rabies Vaccine
10853318|NCT00317473|OG007|Outcome|Imovax Any Imm|Subjects vaccinated within all immunization cycles
10853319|NCT00317473|OG000|Outcome|FMP1/AS02A Malaria Vaccine|Subject vaccinated with FMP1/AS02A
10853320|NCT00317473|OG001|Outcome|Imovax Rabies Vaccine|Subject vaccinated with Imovax Rabies Vaccine
11220978|NCT02337907|EG001|Reported Event|BI 409306 25 mg QD|Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
10853321|NCT00317473|OG002|Outcome|Overall|Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine
10853322|NCT00317473|OG000|Outcome|FMP1/AS02A Malaria Vaccine 10ug (Cohort A)|"Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853323|NCT00317473|OG001|Outcome|Imovax (Cohort A)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
10853324|NCT00317473|OG002|Outcome|FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)|"Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853325|NCT00317473|OG003|Outcome|Imovax (Cohort B)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
10853326|NCT00317473|OG004|Outcome|FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)|"Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
10853327|NCT00317473|OG005|Outcome|Imovax (Cohort C)|"Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days~Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days"
10853328|NCT00317473|EG000|Reported Event|FMP1/AS02A Malaria Vaccine|Subject vaccinated with FMP1/AS02A
10853329|NCT00317473|EG001|Reported Event|Imovax|Subject vaccinated with Imovax Rabies Vaccine
10853330|NCT00317603|BG000|Baseline|Vaccine|"Vaccinations will be administered on days 1,8,15 and every two weeks thereafter until the supply of vaccine has been exhausted or the patient is removed from study. As indicated in 5.2.5, vaccine cell dosage will be approximately 1x10 7 , 4x10 6 ,~1x10 6 , or 1x10 5 depending on the final cell yield.~Autologous, Lethally Irradiated Breast Cancer Cells: Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out"
10853331|NCT00317603|FG000|Participant Flow|Vaccine|"Vaccinations will be administered on days 1,8,15 and every two weeks thereafter until the supply of vaccine has been exhausted or the patient is removed from study. As indicated in 5.2.5, vaccine cell dosage will be approximately 1x10 7 , 4x10 6 ,~1x10 6 , or 1x10 5 depending on the final cell yield.~Autologous, Lethally Irradiated Breast Cancer Cells: Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out"
10853332|NCT00317603|OG000|Outcome|Vaccine|"Vaccinations will be administered on days 1,8,15 and every two weeks thereafter until the supply of vaccine has been exhausted or the patient is removed from study. As indicated in 5.2.5, vaccine cell dosage will be approximately 1x10 7 , 4x10 6 ,~1x10 6 , or 1x10 5 depending on the final cell yield.~Autologous, Lethally Irradiated Breast Cancer Cells: Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out"
10853333|NCT00317603|EG000|Reported Event|Vaccine|"Vaccinations will be administered on days 1,8,15 and every two weeks thereafter until the supply of vaccine has been exhausted or the patient is removed from study. As indicated in 5.2.5, vaccine cell dosage will be approximately 1x10 7 , 4x10 6 ,~1x10 6 , or 1x10 5 depending on the final cell yield.~Autologous, Lethally Irradiated Breast Cancer Cells: Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out"
10853334|NCT00317642|BG000|Baseline|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
10853335|NCT00317642|BG001|Baseline|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
10853336|NCT00317642|BG002|Baseline|Total|Total of all reporting groups
11220979|NCT02337907|EG002|Reported Event|BI 409306 50 mg QD|Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
11220980|NCT02337907|EG003|Reported Event|BI 409306 25 mg Twice Daily (BID)|Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
11220981|NCT02337907|EG004|Reported Event|Placebo Matching BI 409306|Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
11220982|NCT02337907|EG005|Reported Event|Donepezil QD|Patients were administered orally over capsulated tablet of Donepezil once daily for 12 weeks.
10853337|NCT00317642|FG000|Participant Flow|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
10853338|NCT00317642|FG001|Participant Flow|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
10853339|NCT00317642|OG000|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
10878814|NCT00454363|BG000|Baseline|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
11220983|NCT02337933|BG000|Baseline|Ursolic Acid|"Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks~Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast"
11220984|NCT02337933|BG001|Baseline|Placebo|"Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks~Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast"
11220985|NCT02337933|BG002|Baseline|Total|Total of all reporting groups
11220986|NCT02337933|FG000|Participant Flow|Ursolic Acid|"Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks~Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast"
11220987|NCT02337933|FG001|Participant Flow|Placebo|"Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks~Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast"
11220988|NCT02337933|OG000|Outcome|Ursolic Acid|"Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks~Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast"
11220989|NCT02337933|OG001|Outcome|Placebo|"Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks~Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast"
11220990|NCT02337933|EG000|Reported Event|Ursolic Acid|"Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks~Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast"
11220991|NCT02337933|EG001|Reported Event|Placebo|"Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks~Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast"
11220992|NCT02337946|BG000|Baseline|Entire Study Population|Participants who received Panitumumab (Pmab) 6 mg/kg, intravenous drip infusion (DIV), at Day 1, oxaliplatin (OXA) 85 mg/m^2, DIV, at Day 1, levofolinate (l LV) 200 mg/m^2, DIV, at Day 1, fluorouracil (5-FU) 400 mg/m^2, intravenous (IV) at Day 1, 5-FU 2400 mg/m^2, continuous intravenous infusion (CIV), at Day 2 once every two weeks from cycle 1 through cycle 6 as protocol treatment 1 followed by either Pmab 6 mg/kg, DIV, at Day 1, OXA 85 mg/m^2, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 7 until progressive disease or intolerance or Pmab 6 mg/kg, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 7 until progressive disease or intolerance.
11220993|NCT02337946|FG000|Participant Flow|Protocol Treatment 1|Panitumumab (Pmab) 6 mg/kg, intravenous drip infusion (DIV), at Day 1, oxaliplatin (OXA) 85 mg/m^2, DIV, at Day 1, levofolinate (l LV) 200 mg/m^2, DIV, at Day 1, fluorouracil (5-FU) 400 mg/m^2, intravenous (IV) at Day 1, 5-FU 2400 mg/m^2, continuous intravenous infusion (CIV), at Day 2 once every two weeks from cycle 1 through cycle 6 as protocol treatment 1.
11220994|NCT02337946|FG001|Participant Flow|Protocol Treatment Period 2: Group A|Panitumumab (Pmab) 6 mg/kg, intravenous drip infusion (DIV), at Day 1, oxaliplatin (OXA) 85 mg/m^2, DIV, at Day 1, levofolinate (l LV) 200 mg/m^2, DIV, at Day 1, fluorouracil (5-FU) 400 mg/m^2, intravenous (IV) at Day 1, 5-FU 2400 mg/m^2, continuous intravenous infusion (CIV), at Day 2 once every two weeks from cycle 1 through cycle 6 as protocol treatment 1 followed by Pmab 6 mg/kg, DIV, at Day 1, OXA 85 mg/m^2, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 7 until progressive disease or intolerance.
11220995|NCT02337946|FG002|Participant Flow|Protocol Treatment Period 2: Group B|Pmab 6 mg/kg, DIV, at Day 1, OXA 85 mg/m^2, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 1 through cycle 6 as protocol treatment 1 followed by Pmab 6 mg/kg, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 7 until progressive disease or intolerance.
11220996|NCT02337946|OG000|Outcome|Group A|Panitumumab (Pmab) 6 mg/kg, intravenous drip infusion (DIV), at Day 1, oxaliplatin (OXA) 85 mg/m^2, DIV, at Day 1, levofolinate (l LV) 200 mg/m^2, DIV, at Day 1, fluorouracil (5-FU) 400 mg/m^2, intravenous (IV) at Day 1, 5-FU 2400 mg/m^2, continuous intravenous infusion (CIV), at Day 2 once every two weeks from cycle 1 through cycle 6 as protocol treatment 1 followed by Pmab 6 mg/kg, DIV, at Day 1, OXA 85 mg/m^2, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 7 until progressive disease or intolerance.
11220997|NCT02337946|OG001|Outcome|Group B|Pmab 6 mg/kg, DIV, at Day 1, OXA 85 mg/m^2, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 1 through cycle 6 as protocol treatment 1 followed by Pmab 6 mg/kg, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 7 until progressive disease or intolerance.
11220998|NCT02337946|EG000|Reported Event|Group A|Panitumumab (Pmab) 6 mg/kg, intravenous drip infusion (DIV), at Day 1, oxaliplatin (OXA) 85 mg/m^2, DIV, at Day 1, levofolinate (l LV) 200 mg/m^2, DIV, at Day 1, fluorouracil (5-FU) 400 mg/m^2, intravenous (IV) at Day 1, 5-FU 2400 mg/m^2, continuous intravenous infusion (CIV), at Day 2 once every two weeks from cycle 1 through cycle 6 as protocol treatment 1 followed by Pmab 6 mg/kg, DIV, at Day 1, OXA 85 mg/m^2, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 7 until progressive disease or intolerance.
11220999|NCT02337946|EG001|Reported Event|Group B|Pmab 6 mg/kg, DIV, at Day 1, OXA 85 mg/m^2, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 1 through cycle 6 as protocol treatment 1 followed by Pmab 6 mg/kg, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 7 until progressive disease or intolerance.
11221000|NCT02337959|BG000|Baseline|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
11221001|NCT02337959|BG001|Baseline|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
11221002|NCT02337959|BG002|Baseline|Predicate & Investigational-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
11221003|NCT02337959|BG003|Baseline|Total|Total of all reporting groups
10853340|NCT00317642|OG001|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
10853341|NCT00317642|OG002|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
10853342|NCT00317642|OG003|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
10853343|NCT00317642|OG004|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
10853344|NCT00317642|OG005|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
10853345|NCT00317642|OG000|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
10853346|NCT00317642|OG001|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
10853347|NCT00317642|EG000|Reported Event|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
10853348|NCT00317642|EG001|Reported Event|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
10853349|NCT00317642|EG002|Reported Event|Overall|Combined total for the two Arms/Groups
10853350|NCT00317720|BG000|Baseline|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg given orally daily.
11343088|NCT03725982|OG000|Outcome|With Exoskeleton|Subjects performed the condition without the exoskeleton.
10853351|NCT00317720|FG000|Participant Flow|MDACC Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 (Everolimus) 10 mg orally (PO) daily.~Phase II: RAD001 10 mg/kg daily + Trastuzumab 6 mg/kg maintenance dose~ClinicalTrials.gov ID: NCT00317720"
10853352|NCT00317720|FG001|Participant Flow|BIDMC/DFCI Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 5 or 10 mg by mouth daily.~Phase II: RAD001 10 mg/kg daily~ClinicalTrials.gov ID NCT00458237"
10853353|NCT00317720|OG000|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
10853354|NCT00317720|EG000|Reported Event|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
10853355|NCT00317941|BG000|Baseline|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
10853356|NCT00317941|BG001|Baseline|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
10853357|NCT00317941|BG002|Baseline|Total|Total of all reporting groups
10853358|NCT00317941|FG000|Participant Flow|Group A: IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
10853359|NCT00317941|FG001|Participant Flow|Group B: IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
10853360|NCT00317941|FG002|Participant Flow|Group C: IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
10853361|NCT00317941|OG000|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
10853362|NCT00317941|OG001|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
11221004|NCT02337959|FG000|Participant Flow|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
11221005|NCT02337959|FG001|Participant Flow|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
11221006|NCT02337959|FG002|Participant Flow|Predicate & Investigational - Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
11221007|NCT02337959|OG000|Outcome|Predicate|DRX-1 Detector, Cadavers & Live Subjects
11221008|NCT02337959|OG001|Outcome|Investigational|DRX Plus 3543/C (GOS & CsI) Detectors, Cadavers & Live Subjects
11221009|NCT02337959|OG000|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-Plus 3543/C (GOS & CsI) and vice versa.
11221010|NCT02337959|EG000|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
11221011|NCT02337959|EG001|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
11221012|NCT02337959|EG002|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
11221013|NCT02338076|BG000|Baseline|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
11221014|NCT02338076|FG000|Participant Flow|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
11221015|NCT02338076|OG000|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
11221016|NCT02338076|OG001|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
11221017|NCT02338076|OG002|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
11221018|NCT02338076|EG000|Reported Event|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
11343089|NCT03725982|EG000|Reported Event|With Exoskeleton|Subjects performed the conditions (simulated, simplified, industrial standing work) with the exoskeleton.
10845299|NCT00266409|BG001|Baseline|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
10845300|NCT00266409|BG002|Baseline|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
10845301|NCT00266409|BG003|Baseline|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
10845302|NCT00266409|BG004|Baseline|Total|Total of all reporting groups
10845303|NCT00266409|FG000|Participant Flow|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
10845304|NCT00266409|FG001|Participant Flow|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
10845305|NCT00266409|FG002|Participant Flow|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
10845306|NCT00266409|FG003|Participant Flow|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
10845307|NCT00266409|OG000|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
10845308|NCT00266409|OG001|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
10845309|NCT00266409|OG002|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
10845310|NCT00266409|OG003|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
10845311|NCT00266409|EG000|Reported Event|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
10845312|NCT00266409|EG001|Reported Event|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
10853363|NCT00317941|OG000|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
11221019|NCT02338154|BG000|Baseline|Enrolled Cohort|Subjects were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon placed the first guiding suture on the bioprosthesis.
11221020|NCT02338154|FG000|Participant Flow|EDWARDS INTUITY Aortic Valve|Aortic valve replacement therapy Heart Valve Surgery: The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D
10853364|NCT00317941|OG001|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
10853365|NCT00317941|OG002|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
11221021|NCT02338154|OG000|Outcome|INTUITY (Study Valve Cohort)|The study valve cohort consists of all patients that left the operating room with the study valve in place.
11221022|NCT02338154|OG000|Outcome|Enrolled Cohort|Subject were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon placed the first guiding suture on the bioprosthesis.
11221023|NCT02338154|OG000|Outcome|INTUITY (Study Valve Cohort) - 19mm|The study valve cohort consists of all patients that left the operating room with the study valve in place.
11221024|NCT02338154|OG001|Outcome|INTUITY (Study Valve Cohort) - 21mm|The study valve cohort consists of all patients that left the operating room with the study valve in place.
11221025|NCT02338154|OG002|Outcome|INTUITY (Study Valve Cohort) - 23mm|The study valve cohort consists of all patients that left the operating room with the study valve in place.
11221026|NCT02338154|OG003|Outcome|INTUITY (Study Valve Cohort) - 25mm|The study valve cohort consists of all patients that left the operating room with the study valve in place.
11221027|NCT02338154|OG004|Outcome|INTUITY (Study Valve Cohort) - 27mm|The study valve cohort consists of all patients that left the operating room with the study valve in place.
11221028|NCT02338154|OG005|Outcome|INTUITY (Study Valve Cohort) - Overall|The study valve cohort consists of all patients that left the operating room with the study valve in place.
10853366|NCT00317941|EG000|Reported Event|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light. Participants at risk from Group A and Group B in Participant flow.
11343090|NCT03725982|EG001|Reported Event|Without Exoskeleton|Subjects performed the conditions (simulated, simplified, industrial standing work) without the exoskeleton.
10853367|NCT00317941|EG001|Reported Event|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II. Participants at risk from Group C in Participant flow.
11221029|NCT02338154|OG000|Outcome|INUTITY (Study Valve Cohort) - 19mm|The study valve cohort consists of all patients that left the operating room with the study valve in place.
11221030|NCT02338154|EG000|Reported Event|Enrolled Cohort|Subject's were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon places the first guiding suture on the bioprosthesis.
11221031|NCT02338193|BG000|Baseline|DAPA/MET XR|"Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks~DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks"
11221032|NCT02338193|BG001|Baseline|Dapaglifloxin|"Dapagliflozin- 10 mg once daily before first meal for 24 weeks~DAPA: 10 mg dapagliflozin QD for 20-24 weeks"
11221033|NCT02338193|BG002|Baseline|Metformin XR|"Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks~MET XR: 1000 mg Metformin XR BID for 20-24 weeks"
11221034|NCT02338193|BG003|Baseline|Total|Total of all reporting groups
11221035|NCT02338193|FG000|Participant Flow|DAPA/MET XR|"Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks~DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks"
11221036|NCT02338193|FG001|Participant Flow|Dapaglifloxin|"Dapagliflozin- 10 mg once daily before first meal for 24 weeks~DAPA: 10 mg dapagliflozin QD for 20-24 weeks"
11221037|NCT02338193|FG002|Participant Flow|Metformin XR|"Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks~MET XR: 1000 mg Metformin XR BID for 20-24 weeks"
11221038|NCT02338193|OG000|Outcome|DAPA/MET XR|"Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks~DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks"
11221039|NCT02338193|OG001|Outcome|Dapaglifloxin|"Dapagliflozin- 10 mg once daily before first meal for 24 weeks~DAPA: 10 mg dapagliflozin QD for 20-24 weeks"
11221040|NCT02338193|OG002|Outcome|Metformin XR|"Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks~MET XR: 1000 mg Metformin XR BID for 20-24 weeks"
11221041|NCT02338193|EG000|Reported Event|DAPA/MET XR|"Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks~DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks"
11221042|NCT02338193|EG001|Reported Event|Dapaglifloxin|"Dapagliflozin- 10 mg once daily before first meal for 24 weeks~DAPA: 10 mg dapagliflozin QD for 20-24 weeks"
11221043|NCT02338193|EG002|Reported Event|Metformin XR|"Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks~MET XR: 1000 mg Metformin XR BID for 20-24 weeks"
11221044|NCT02338336|BG000|Baseline|Placebo|Matching Placebo
11221045|NCT02338336|BG001|Baseline|Nowarta110|All combined Nowarta110 doses
11221046|NCT02338336|BG002|Baseline|Total|Total of all reporting groups
11221047|NCT02338336|FG000|Participant Flow|Placebo|Matching Placebo
10853368|NCT00318136|BG000|Baseline|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
11098813|NCT01578044|EG000|Reported Event|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
11221048|NCT02338336|FG001|Participant Flow|Norwarta110 3 Drops|Nowarta110 3 drops administered topically
11221049|NCT02338336|FG002|Participant Flow|Nowarta110 6 Drops|Nowarta110 6 drops administered topically
11221050|NCT02338336|FG003|Participant Flow|Nowarta110 10 Drops|Nowarta110 10 drops administered topically
10878815|NCT00454363|BG001|Baseline|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
11098814|NCT01578044|EG001|Reported Event|Usual Care Group|"Usual care~All patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Also, following their enrollment in the study will receive the additional educational materials given to the intervention group during their time in the study."
11098815|NCT01578187|BG000|Baseline|Hair2Go Device|The subjects who participated in the label comprehension phase, of them most participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
11098816|NCT01578187|FG000|Participant Flow|Hair2Go Device|"This group included subjects who participated in the label comprehension phase. From these subjects, 48 subjects self-included in the usability phase (no contraindications) and chose to use the device for 1 treatment.~The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM) test."
11098817|NCT01578187|OG000|Outcome|Label Comprehension Group|Subjects that participated in the label comprehension phase of the study
11098818|NCT01578187|OG000|Outcome|Usability - Critical Error|Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence
11098819|NCT01578187|OG001|Outcome|Usability - Non Critical Error|Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
11098820|NCT01578187|EG000|Reported Event|Hair2Go (Me) Device|The subjects who participated in the label comprehension phase; the majority of whom participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
11098821|NCT01578278|BG000|Baseline|Bepotastine Besilate-fluticasone Propionate|"Nasal Spray~Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray"
11098822|NCT01578278|BG001|Baseline|Bepotastine Besilate Formulation|"Nasal Spray~Bepotastine besilate formulation 4%: Nasal Spray"
11098823|NCT01578278|BG002|Baseline|Fluticasone Propionate|"Nasal Spray~Fluticasone propionate 0.05%: Nasal Spray"
11098824|NCT01578278|BG003|Baseline|Placebo Comparator|"Nasal Spray~Placebo Comparator: Nasal Spray"
11098825|NCT01578278|BG004|Baseline|Total|Total of all reporting groups
11098826|NCT01578278|FG000|Participant Flow|Bepotastine Besilate-fluticasone Propionate|"Nasal Spray~Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray"
11098827|NCT01578278|FG001|Participant Flow|Bepotastine Besilate Formulation|"Nasal Spray~Bepotastine besilate formulation 4%: Nasal Spray"
11098828|NCT01578278|FG002|Participant Flow|Fluticasone Propionate|"Nasal Spray~Fluticasone propionate 0.05%: Nasal Spray"
11098829|NCT01578278|FG003|Participant Flow|Placebo Comparator|"Nasal Spray~Placebo Comparator: Nasal Spray"
11098830|NCT01578278|OG000|Outcome|Bepotastine Besilate-fluticasone Propionate|"Nasal Spray~Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray"
11098831|NCT01578278|OG001|Outcome|Bepotastine Besilate Formulation|"Nasal Spray~Bepotastine besilate formulation 4%: Nasal Spray"
11098832|NCT01578278|OG002|Outcome|Fluticasone Propionate|"Nasal Spray~Fluticasone propionate 0.05%: Nasal Spray"
11098833|NCT01578278|OG003|Outcome|Placebo Comparator|"Nasal Spray~Placebo Comparator: Nasal Spray"
11098834|NCT01578278|EG000|Reported Event|Bepotastine Besilate-fluticasone Propionate|"Nasal Spray~Bepotastine besilate-fluticasone propionate: Nasal Spray"
11098835|NCT01578278|EG001|Reported Event|Bepotastine Besilate Formulation|"Nasal Spray~Bepotastine besilate formulation: Nasal Spray"
11098836|NCT01578278|EG002|Reported Event|Fluticasone Propionate|"Nasal Spray~Fluticasone propionate: Nasal Spray"
11098837|NCT01578278|EG003|Reported Event|Placebo Comparator|"Nasal Spray~Placebo Comparator: Nasal Spray"
11098838|NCT01578317|BG000|Baseline|AS03 Adjuvanted|"Adminsitered day 1, booster at Day 21~H5N1 vaccine plus AS03 adjuvant: H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart."
11098839|NCT01578317|BG001|Baseline|Unadjuvanted|"Administer day 1 and booster at Day 21~H5N1 vaccine without adjuvant: H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart."
11098840|NCT01578317|BG002|Baseline|Total|Total of all reporting groups
11098841|NCT01578317|FG000|Participant Flow|AS03 Adjuvanted|"Adminsitered day 1, booster at Day 21~H5N1 vaccine plus AS03 adjuvant: H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart."
11221051|NCT02338336|OG000|Outcome|Placebo|Matching Placebo
11221052|NCT02338336|OG001|Outcome|TREATMENT|Nowarta110
11221053|NCT02338336|EG000|Reported Event|Placebo|Matching Placebo
11221054|NCT02338336|EG001|Reported Event|Nowarta110|All combined Nowarta110 doses
11221055|NCT02338362|BG000|Baseline|Fluticasone|participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
11221056|NCT02338362|BG001|Baseline|Saline Placebo|participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
10853369|NCT00318136|FG000|Participant Flow|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
10853370|NCT00318136|OG000|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
10853371|NCT00318136|EG000|Reported Event|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
10853372|NCT00318149|BG000|Baseline|Fluarix 18-40 Y Group|Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10853373|NCT00318149|BG001|Baseline|Fluarix ≥65 Y Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10853374|NCT00318149|BG002|Baseline|Fluarix-AS25 Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
10853375|NCT00318149|BG003|Baseline|Fluarix-AS50 Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
10853376|NCT00318149|BG004|Baseline|Fluarix- AS01B Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
10853377|NCT00318149|BG005|Baseline|Fluarix- AS01E Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
10853378|NCT00318149|BG006|Baseline|Total|Total of all reporting groups
10853379|NCT00318149|FG000|Participant Flow|Fluarix 18-40 Y Group|Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10853380|NCT00318149|FG001|Participant Flow|Fluarix ≥65 Y Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10853381|NCT00318149|FG002|Participant Flow|Fluarix-AS25 Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
10853382|NCT00318149|FG003|Participant Flow|Fluarix-AS50 Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
10853383|NCT00318149|FG004|Participant Flow|Fluarix- AS01B Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
10853384|NCT00318149|FG005|Participant Flow|Fluarix- AS01E Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
10853385|NCT00318149|OG000|Outcome|Fluarix 18-40 Y Group|Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10853386|NCT00318149|OG001|Outcome|Fluarix ≥65 Y Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10853387|NCT00318149|OG002|Outcome|Fluarix-AS25 Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
10853388|NCT00318149|OG003|Outcome|Fluarix-AS50 Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
10853389|NCT00318149|OG004|Outcome|Fluarix- AS01B Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
10853390|NCT00318149|OG005|Outcome|Fluarix- AS01E Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
10853391|NCT00318149|OG004|Outcome|Fluarix-AS01B Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
10853392|NCT00318149|OG005|Outcome|Fluarix-AS01E Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
10853393|NCT00318149|EG000|Reported Event|Fluarix 18-40 Y Group|Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10853394|NCT00318149|EG001|Reported Event|Fluarix ≥65 Y Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10853395|NCT00318149|EG002|Reported Event|Fluarix-AS25 Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
10853396|NCT00318149|EG003|Reported Event|Fluarix-AS50 Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
10853397|NCT00318149|EG004|Reported Event|Fluarix- AS01B Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
10853398|NCT00318149|EG005|Reported Event|Fluarix- AS01E Group|Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
10853399|NCT00318292|BG000|Baseline|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
10853400|NCT00318292|BG001|Baseline|Placebo|Placebo for preemptive local analgesia.
10853401|NCT00318292|BG002|Baseline|Total|Total of all reporting groups
10853402|NCT00318292|FG000|Participant Flow|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
11221057|NCT02338362|BG002|Baseline|Total|Total of all reporting groups
11221058|NCT02338362|FG000|Participant Flow|Steroid Inhaler|randomized to 6 weeks of 1 puff twice daily 250ug fluticasone propionate inhaled.
11221059|NCT02338362|FG001|Participant Flow|Placebo Inhaler|randomized to 6 weeks of 1 puff twice daily saline inhaled.
11221060|NCT02338362|OG000|Outcome|Fluticasone|participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
11221061|NCT02338362|OG001|Outcome|Saline Placebo|participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
11221062|NCT02338362|EG000|Reported Event|Fluticasone|participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
11221063|NCT02338362|EG001|Reported Event|Saline Placebo|participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
11221064|NCT02338492|BG000|Baseline|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
11221065|NCT02338492|FG000|Participant Flow|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
11221066|NCT02338492|OG000|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
11221067|NCT02338492|EG000|Reported Event|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
11221068|NCT02338713|BG000|Baseline|Noncarbonated Water+Calcichew D3|Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
11221069|NCT02338713|FG000|Participant Flow|Noncarbonated Water+Calcichew D3|Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
11221070|NCT02338713|OG000|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
11221071|NCT02338713|OG001|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
11221072|NCT02338713|EG000|Reported Event|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
11221073|NCT02338713|EG001|Reported Event|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
11221074|NCT02338843|BG000|Baseline|LJPC-501 (Angiotensin II)|"Treatment arm~LJPC-501: Treatment arm"
11221075|NCT02338843|BG001|Baseline|Placebo (0.9% Sodium Chloride Solution)|"Placebo arm~Placebo: PBO"
11221076|NCT02338843|BG002|Baseline|Total|Total of all reporting groups
11221077|NCT02338843|FG000|Participant Flow|LJPC-501 (Angiotensin II)|Treatment arm Injection for Intravenous Infusion
11221078|NCT02338843|FG001|Participant Flow|Placebo (0.9% Sodium Chloride Solution)|Placebo arm Volume matched saline administered via intravenous infusion
11221079|NCT02338843|OG000|Outcome|LJPC-501 (Angiotensin II)|"Treatment arm~LJPC-501: Treatment arm"
11221080|NCT02338843|OG001|Outcome|Placebo (0.9% Sodium Chloride Solution)|"Placebo arm~Placebo: PBO"
11221081|NCT02338843|EG000|Reported Event|LJPC-501 (Angiotensin II)|"Treatment arm~LJPC-501: Treatment arm"
11221082|NCT02338843|EG001|Reported Event|Placebo (0.9% Sodium Chloride Solution)|"Placebo arm~Placebo: PBO"
11221083|NCT02338882|BG000|Baseline|Bi Flex M Monofocal Intraocular Lens|"Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens~Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens"
10853403|NCT00318292|FG001|Participant Flow|Placebo|Placebo for preemptive local analgesia.
10853404|NCT00318292|OG000|Outcome|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
10853405|NCT00318292|OG001|Outcome|Placebo|Placebo for preemptive local analgesia.
10853406|NCT00318292|EG000|Reported Event|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
11221084|NCT02338882|BG001|Baseline|Bi Flex M Multifocal Intraocular Lens|"Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens~Bi flex M multifocal intraocular lens: Multifocal intraocular lens"
11221085|NCT02338882|BG002|Baseline|Total|Total of all reporting groups
11221086|NCT02338882|FG000|Participant Flow|Bi Flex M Multifocal Intraocular Lens|"Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens~Bi flex M multifocal intraocular lens: Multifocal intraocular lens"
11221087|NCT02338882|FG001|Participant Flow|Bi Flex 1.8 Monofocal Intraocular|"Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens~Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens"
10853407|NCT00318292|EG001|Reported Event|Placebo|Placebo for preemptive local analgesia.
10853408|NCT00318357|BG000|Baseline|Cardiac Resynchromization Therapy (Control Pts in CARE-HF)|"In the CARE-HF study patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, almost all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality.~CARE-HF LTFU study continued to follow up the original CARE-HF control group patients. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine."
10878816|NCT00454363|BG002|Baseline|Total|Total of all reporting groups
10845313|NCT00266409|EG002|Reported Event|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
10845314|NCT00266409|EG003|Reported Event|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
10845315|NCT00266630|BG000|Baseline|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
10845316|NCT00266630|BG001|Baseline|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
10845317|NCT00266630|BG002|Baseline|Total|Total of all reporting groups
10845318|NCT00266630|FG000|Participant Flow|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
10845319|NCT00266630|FG001|Participant Flow|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
10845320|NCT00266630|OG000|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
10845321|NCT00266630|OG000|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
10845322|NCT00266630|OG000|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
10845323|NCT00266630|OG001|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
10845324|NCT00266630|EG000|Reported Event|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
10845325|NCT00266630|EG001|Reported Event|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
10845326|NCT00266656|BG000|Baseline|Early Treated|Early treated n=36
10845327|NCT00266656|BG001|Baseline|Early Untreated|Early untreated n=33
10845328|NCT00266656|BG002|Baseline|Total|Total of all reporting groups
10845329|NCT00266656|FG000|Participant Flow|Early Treated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
10845330|NCT00266656|FG001|Participant Flow|Early Untreated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
10845331|NCT00266656|OG000|Outcome|Early Treated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
10845332|NCT00266656|OG001|Outcome|Early Untreated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
10845333|NCT00266656|EG000|Reported Event|Early Treated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
10845334|NCT00266656|EG001|Reported Event|Early Untreated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
10845335|NCT00266695|BG000|Baseline|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
10845336|NCT00266695|FG000|Participant Flow|Ruboxistaurin|32 milligrams (mg) given once daily as an oral tablet for 2 years.
10845337|NCT00266695|OG000|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
10845338|NCT00266695|EG000|Reported Event|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
10845339|NCT00266708|BG000|Baseline|Risedronate|"subjects received Risedronate for one year~Risedronate 35 Mg: risedronate 35 mg weekly"
10845340|NCT00266708|BG001|Baseline|Placebo|"subjects received placebo for 1 year~Placebo weekly"
10845341|NCT00266708|BG002|Baseline|Total|Total of all reporting groups
10845342|NCT00266708|FG000|Participant Flow|Risedronate|"subjects received Risedronate for one year~Risedronate 35 Mg: risedronate 35 mg weekly"
10845343|NCT00266708|FG001|Participant Flow|Placebo|"subjects received placebo for 1 year~Placebo weekly"
10845344|NCT00266708|OG000|Outcome|Risedronate|"subjects received Risedronate for one year~Risedronate 35 Mg: risedronate 35 mg weekly"
10845345|NCT00266708|OG001|Outcome|Placebo|"subjects received placebo for 1 year~Placebo weekly"
10845346|NCT00266708|EG000|Reported Event|Risedronate|"subjects received Risedronate for one year~Risedronate 35 Mg: risedronate 35 mg weekly"
10845347|NCT00266708|EG001|Reported Event|Placebo|"subjects received placebo for 1 year~Placebo weekly"
10853409|NCT00318357|BG001|Baseline|Cardiac Resynchromization Therapy|"In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.~Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine."
10853410|NCT00318357|BG002|Baseline|Total|Total of all reporting groups
10853411|NCT00318357|FG000|Participant Flow|Cardiac Resynchromization Therapy|"In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.~Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine."
10853412|NCT00318357|FG001|Participant Flow|Cardiac Resynchromization Therapy (Control Pts in CARE-HF|"In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. After release~Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine."
10853413|NCT00318357|OG000|Outcome|Cardiac Resynchronization Therapy|"In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.~Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine."
10853414|NCT00318357|OG001|Outcome|Upgrade to Cardiac Resynchronization Therapy|"In the CARE-HF study patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, almost all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality.~CARE-HF LTFU study continued to follow up the original CARE-HF control group patients. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine."
10853415|NCT00318357|EG000|Reported Event|Cardiac REsynchronization Therapy|
10853416|NCT00318357|EG001|Reported Event|Upgrade to Cardiac Resynchronization Therapy|CARE-HF LTFU study continued to follow up the original CARE-HF control group patients. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.
10853417|NCT00318370|BG000|Baseline|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).~Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.~Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
10853418|NCT00318370|FG000|Participant Flow|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
10853419|NCT00318370|FG001|Participant Flow|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
10853420|NCT00318370|FG002|Participant Flow|Maintenance Far Only|Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.
10853421|NCT00318370|OG000|Outcome|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
10853422|NCT00318370|OG000|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
10853423|NCT00318370|OG000|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.~Maintenace Far Only: farletuzumab, 100 mg/m2"
10853424|NCT00318370|EG000|Reported Event|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).~Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.~Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
10853425|NCT00318409|BG000|Baseline|Bupropion|Bupropion XL 300mg daily
10853426|NCT00318409|BG001|Baseline|Placebo|Placebo 300mg daily
10853427|NCT00318409|BG002|Baseline|Total|Total of all reporting groups
10853428|NCT00318409|FG000|Participant Flow|Bupropion|Bupropion XL 300mg daily
10853429|NCT00318409|FG001|Participant Flow|Placebo|Placebo 300mg daily
10853430|NCT00318409|OG000|Outcome|Persons Screened|
10853431|NCT00318409|OG000|Outcome|Bupropion|
10853432|NCT00318409|OG001|Outcome|Placebo|
10853433|NCT00318409|EG000|Reported Event|Bupropion|
10853434|NCT00318409|EG001|Reported Event|Placebo|
10853435|NCT00318461|BG000|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853436|NCT00318461|BG001|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853437|NCT00318461|BG002|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853438|NCT00318461|BG003|Baseline|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853439|NCT00318461|BG004|Baseline|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853440|NCT00318461|BG005|Baseline|Total|Total of all reporting groups
10878817|NCT00454363|FG000|Participant Flow|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
10853441|NCT00318461|FG000|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853442|NCT00318461|FG001|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
11221088|NCT02338882|OG000|Outcome|Bi Flex 1.8 Monofocal Intraocular|"Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens~Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens"
11221089|NCT02338882|OG001|Outcome|Bi Flex M Multifocal Intraocular Lens|"Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens~Bi flex M multifocal intraocular lens: Multifocal intraocular lens"
11221090|NCT02338882|OG000|Outcome|Bi Flex M Multifocal Intraocular Lens|"Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens~Bi flex M multifocal intraocular lens: Multifocal intraocular lens"
11221091|NCT02338882|OG001|Outcome|Bi Flex 1.8 Monofocal Intraocular|"Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens~Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens"
11221092|NCT02338882|OG000|Outcome|Bi Flex M Monofocal Intraocular Lens|"Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens~Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens"
11221093|NCT02338882|EG000|Reported Event|Bi Flex 1.8 Monofocal Intraocular|"Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens~Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens"
10853443|NCT00318461|FG002|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853444|NCT00318461|FG003|Participant Flow|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
11221094|NCT02338882|EG001|Reported Event|Bi Flex M Multifocal Intraocular Lens|"Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens~Bi flex M multifocal intraocular lens: Multifocal intraocular lens"
11221095|NCT02338960|BG000|Baseline|Bremelanotide (BMT/BMT)|"Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE)~BMT/BMT~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
10853445|NCT00318461|FG004|Participant Flow|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853446|NCT00318461|OG000|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853447|NCT00318461|OG001|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853448|NCT00318461|OG002|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853449|NCT00318461|OG003|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
11221096|NCT02338960|BG001|Baseline|Placebo (PBO/BMT)|"Subjects will self-administer a fixed dose of placebo (PBO) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE) where participants receive only BMT, no placebo~PBO/BMT~Placebo: Placebo bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11221097|NCT02338960|BG002|Baseline|Total|Total of all reporting groups
11221098|NCT02338960|FG000|Participant Flow|Placebo PBO/BMT|"Core Study: Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.~Placebo~OLE Study: Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks.~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11221099|NCT02338960|FG001|Participant Flow|Brememlanotide BMT/BMT|"Core and OLE Study: Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11221100|NCT02338960|OG000|Outcome|Bremelanotide BMT/BMT|"(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks~(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks~Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11221101|NCT02338960|OG001|Outcome|Placebo PBO/BMT|"(Main Study) PBO administered SC on an as-desired basis for 24 weeks~Placebo: Placebo~(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks~Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
10853450|NCT00318461|OG004|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
11221102|NCT02338960|OG000|Outcome|Bremelanotide BMT|"(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks~Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11221103|NCT02338960|OG001|Outcome|Placebo PBO|"Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.~Placebo: Placebo"
11221104|NCT02338960|OG000|Outcome|Bremelanotide BMT|"(Main Study) Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.~Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11221105|NCT02338960|EG000|Reported Event|Bremelanotide (Main Study)|"Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.~Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11221106|NCT02338960|EG001|Reported Event|Placebo (Main Study)|"Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.~Placebo: Placebo"
11221107|NCT02338960|EG002|Reported Event|Bremelanotide (OLE)|"Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.~Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11221108|NCT02338960|EG003|Reported Event|Placebo (OLE)|"Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.~Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
10853451|NCT00318461|EG000|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853452|NCT00318461|EG001|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853453|NCT00318461|EG002|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853454|NCT00318461|EG003|Reported Event|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10853455|NCT00318461|EG004|Reported Event|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
10878818|NCT00454363|FG001|Participant Flow|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
10878819|NCT00454363|OG000|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
11221109|NCT02338973|BG000|Baseline|Interferon Gamma-1b|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221110|NCT02338973|FG000|Participant Flow|Interferon Gamma-1b|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221111|NCT02338973|OG000|Outcome|Interferon Gamma-1b|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221112|NCT02338973|OG000|Outcome|Interferon Gamma-1b|Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
11221113|NCT02338973|OG000|Outcome|BCVA at Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221114|NCT02338973|OG001|Outcome|BCVA at Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221115|NCT02338973|OG002|Outcome|BCVA at Day 1 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221116|NCT02338973|OG003|Outcome|BCVA at Day 1 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221117|NCT02338973|OG004|Outcome|Difference in BCVA at Day 1 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221118|NCT02338973|OG005|Outcome|Difference in BCVA at Day 1 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221119|NCT02338973|OG002|Outcome|BCVA at Day 2 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221120|NCT02338973|OG003|Outcome|BCVA at Day 2 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221121|NCT02338973|OG004|Outcome|Difference in BCVA at Day 2 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221122|NCT02338973|OG005|Outcome|Difference in BCVA at Day 2 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221123|NCT02338973|OG002|Outcome|BCVA at Day 3 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853456|NCT00318474|BG000|Baseline|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
10853457|NCT00318474|BG001|Baseline|Placebo|Subjects receive ACEi and FOS and placebo.
10853458|NCT00318474|BG002|Baseline|Total|Total of all reporting groups
10853459|NCT00318474|FG000|Participant Flow|Mycophenolate Mofetil (MMF)|"Subjects receive angiotensin-converting enzyme inhibitors (ACEi), fish oil supplements (FOS), and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
10853460|NCT00318474|FG001|Participant Flow|Placebo|Subjects receive ACEi and FOS and placebo.
10853461|NCT00318474|OG000|Outcome|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
10853462|NCT00318474|OG001|Outcome|Placebo|Subjects receive ACEi and FOS and placebo.
11221124|NCT02338973|OG003|Outcome|BCVA at Day 3 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853463|NCT00318474|EG000|Reported Event|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
10853464|NCT00318474|EG001|Reported Event|Placebo|Subjects receive ACEi and FOS and placebo.
10853465|NCT00318565|BG000|Baseline|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
10853466|NCT00318565|FG000|Participant Flow|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
10853467|NCT00318565|OG000|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
10853468|NCT00318565|EG000|Reported Event|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
10853469|NCT00318591|BG000|Baseline|SpeediCath|Hydrophilic coated intermittent catheter
10853470|NCT00318591|BG001|Baseline|Conveen Uncoated|Uncoated intermittent catheter
10853471|NCT00318591|BG002|Baseline|Total|Total of all reporting groups
10853472|NCT00318591|FG000|Participant Flow|SpeediCath|Hydrophilic coated intermittent catheter
10853473|NCT00318591|FG001|Participant Flow|Conveen Uncoated|Uncoated intermittent catheter
10853474|NCT00318591|OG000|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
10853475|NCT00318591|OG001|Outcome|Conveen Uncoated|uncoated intermittent catheter
10853476|NCT00318591|OG001|Outcome|Conveen Uncoated|Uncoated intermittent catheter
10853477|NCT00318591|OG000|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
10853478|NCT00318591|EG000|Reported Event|SpeediCath|Hydrophilic coated intermittent catheter
10853479|NCT00318591|EG001|Reported Event|Conveen Uncoated|Uncoated intermittent catheter
10853480|NCT00318643|BG000|Baseline|Cohort 1: MMC Plus Chemophase 20,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853481|NCT00318643|BG001|Baseline|Cohort 2: MMC Plus Chemophase 60,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853482|NCT00318643|BG002|Baseline|Cohort 3: MMC Plus Chemophase 200,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853483|NCT00318643|BG003|Baseline|Cohort 4: MMC Plus Chemophase 400,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853484|NCT00318643|BG004|Baseline|Cohort 5: MMC Plus Chemophase 800,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853485|NCT00318643|BG005|Baseline|Total|Total of all reporting groups
10853486|NCT00318643|FG000|Participant Flow|Cohort 1: MMC Plus Chemophase 20,000 U|Participants received 40 milligrams (mg) mitomycin C (MMC) intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 Units (U) Chemophase intravesically once weekly from Weeks 2 through 6.
10853487|NCT00318643|FG001|Participant Flow|Cohort 2: MMC Plus Chemophase 60,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853488|NCT00318643|FG002|Participant Flow|Cohort 3: MMC Plus Chemophase 200,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
11221125|NCT02338973|OG004|Outcome|Difference in BCVA at Day 3 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221126|NCT02338973|OG005|Outcome|Difference in BCVA at Day 3 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221127|NCT02338973|OG002|Outcome|BCVA at Week 2 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221128|NCT02338973|OG003|Outcome|BCVA at Week 2 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853489|NCT00318643|FG003|Participant Flow|Cohort 4: MMC Plus Chemophase 400,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853490|NCT00318643|FG004|Participant Flow|Cohort 5: MMC Plus Chemophase 800,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853491|NCT00318643|OG000|Outcome|Cohort 5: MMC Plus Chemophase 800,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853492|NCT00318643|OG000|Outcome|Cohort 1: MMC Plus Chemophase 20,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853493|NCT00318643|OG001|Outcome|Cohort 2: MMC Plus Chemophase 60,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853494|NCT00318643|OG002|Outcome|Cohort 3: MMC Plus Chemophase 200,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853495|NCT00318643|OG003|Outcome|Cohort 4: MMC Plus Chemophase 400,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853496|NCT00318643|OG004|Outcome|Cohort 5: MMC Plus Chemophase 800,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
11221129|NCT02338973|OG004|Outcome|Difference in BCVA at Week 2 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853497|NCT00318643|EG000|Reported Event|Cohort 1: MMC Plus Chemophase 20,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853498|NCT00318643|EG001|Reported Event|Cohort 2: MMC Plus Chemophase 60,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853499|NCT00318643|EG002|Reported Event|Cohort 3: MMC Plus Chemophase 200,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853500|NCT00318643|EG003|Reported Event|Cohort 4: MMC Plus Chemophase 400,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853501|NCT00318643|EG004|Reported Event|Cohort 5: MMC Plus Chemophase 800,000 U|Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
10853502|NCT00318708|BG000|Baseline|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
10853503|NCT00318708|BG001|Baseline|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
10853504|NCT00318708|BG002|Baseline|Total|Total of all reporting groups
10853505|NCT00318708|FG000|Participant Flow|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
10853506|NCT00318708|FG001|Participant Flow|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
10853507|NCT00318708|OG000|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
10853508|NCT00318708|OG001|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
10853509|NCT00318708|OG000|Outcome|Clarithromycin + Fluticasone|"clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)~clarithromycin: clarithromycin 500 mg twice daily (Biaxin)~fluticasone propionate: fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)"
10853510|NCT00318708|OG001|Outcome|Placebo + Fluticasone|"placebo clarithromycin twice daily + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)~fluticasone propionate: fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)~placebo clarithromycin: placebo clarithromycin twice daily"
10853511|NCT00318708|OG000|Outcome|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
10853512|NCT00318708|OG001|Outcome|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
10853513|NCT00318708|EG000|Reported Event|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
10853514|NCT00318708|EG001|Reported Event|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
10853515|NCT00318812|BG000|Baseline|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
10853516|NCT00318812|BG001|Baseline|Iron Sucrose|Iron Sucrose q month IV x 6 months
10853517|NCT00318812|BG002|Baseline|Total|Total of all reporting groups
10853518|NCT00318812|FG000|Participant Flow|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
10853519|NCT00318812|FG001|Participant Flow|Iron Sucrose|Iron Sucrose q month IV x 6 months
10853520|NCT00318812|OG000|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
10853521|NCT00318812|OG001|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
10853522|NCT00318812|EG000|Reported Event|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
10853523|NCT00318812|EG001|Reported Event|Iron Sucrose|Iron Sucrose q month IV x 6 months
10853524|NCT00318929|BG000|Baseline|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
10853525|NCT00318929|FG000|Participant Flow|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
10853526|NCT00318929|OG000|Outcome|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
11221130|NCT02338973|OG005|Outcome|Difference in BCVA at Week 2 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221131|NCT02338973|OG002|Outcome|BCVA at Week 5 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221132|NCT02338973|OG003|Outcome|BCVA at Week 5 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221133|NCT02338973|OG004|Outcome|Difference in BCVA at Week 5 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221134|NCT02338973|OG005|Outcome|Difference in BCVA at Week 5 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221135|NCT02338973|OG002|Outcome|BCVA at Week 8 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221136|NCT02338973|OG003|Outcome|BCVA at Week 8 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221137|NCT02338973|OG004|Outcome|Difference in BCVA at Week 8 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221138|NCT02338973|OG005|Outcome|Difference in BCVA at Week 8 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853527|NCT00318929|EG000|Reported Event|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
10853528|NCT00319020|BG000|Baseline|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
10853529|NCT00319020|BG001|Baseline|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
10853530|NCT00319020|BG002|Baseline|Total|Total of all reporting groups
10878820|NCT00454363|OG001|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
10878821|NCT00454363|EG000|Reported Event|Pazopanib|Oral pazopanib hydrochloride once daily on days 1-28.
11221139|NCT02338973|OG002|Outcome|BCVA at Week 52 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221140|NCT02338973|OG003|Outcome|BCVA at Week 52 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221141|NCT02338973|OG004|Outcome|Difference in BCVA at Week 52 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221142|NCT02338973|OG005|Outcome|Difference in BCVA at Week 52 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221143|NCT02338973|OG000|Outcome|Subretinal Fluid Volume at Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221144|NCT02338973|OG001|Outcome|Subretinal Fluid Volume at Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221145|NCT02338973|OG002|Outcome|Subretinal Fluid Volume at Day 1 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221146|NCT02338973|OG003|Outcome|Subretinal Fluid Volume at Day1 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221147|NCT02338973|OG004|Outcome|Difference at Day 1 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221148|NCT02338973|OG005|Outcome|Difference at Day 1 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221149|NCT02338973|OG002|Outcome|Subretinal Fluid Volume at Day 2 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221150|NCT02338973|OG003|Outcome|Subretinal Fluid Volume at Day 2 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221151|NCT02338973|OG004|Outcome|Difference at Day 2 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221152|NCT02338973|OG005|Outcome|Difference at Day 2 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221153|NCT02338973|OG002|Outcome|Subretinal Fluid Volume at Day 3 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221154|NCT02338973|OG003|Outcome|Subretinal Fluid Volume at Day 3 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221155|NCT02338973|OG004|Outcome|Difference at Day 3 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221156|NCT02338973|OG005|Outcome|Difference at Day 3 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853531|NCT00319020|FG000|Participant Flow|Patients With Previous Bosentan|"This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiatied at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
10853532|NCT00319020|FG001|Participant Flow|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
10853533|NCT00319020|OG000|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
10853534|NCT00319020|OG001|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
10853535|NCT00319020|OG002|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
10853536|NCT00319020|EG000|Reported Event|Patients With Previous Bosentan|Patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2
10853537|NCT00319020|EG001|Reported Event|Bosentan_naive Patients|Patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2
10853538|NCT00319020|EG002|Reported Event|Single Arm Bosentan_Total|All patients included in Future 1 / FUTURE 2 whether they received bosentan or not bosentan before enrollment in FUTURE 1
10853539|NCT00319046|BG000|Baseline|Miglustat|Oral administration of miglustat 100 mg t.i.d. for a period of 2 years
10853540|NCT00319046|FG000|Participant Flow|Miglustat|Oral administration of miglustat 100 mg t.i.d. for a period of 2 years
10853541|NCT00319046|OG000|Outcome|Miglustat|Oral administration of miglustat 100 mg t.i.d. for a period of 2 years
10853542|NCT00319046|EG000|Reported Event|Miglustat|Oral administration of miglustat 100 mg t.i.d. (median time exposure = 658 days)
10878822|NCT00454532|BG000|Baseline|Level 1|10g/day
10878823|NCT00454532|BG001|Baseline|Level 2|20g/day
10878824|NCT00454532|BG002|Baseline|Level 3|30g/day
10878825|NCT00454532|BG003|Baseline|Level 4|40g/day
10878826|NCT00454532|BG004|Baseline|Total|Total of all reporting groups
11221157|NCT02338973|OG002|Outcome|Subretinal Fluid Volume at Week 2 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10878827|NCT00454532|FG000|Participant Flow|Level 1|10g/day
10878828|NCT00454532|FG001|Participant Flow|Level 2|20g/day
10878829|NCT00454532|FG002|Participant Flow|Level 3|30g/day
10878830|NCT00454532|FG003|Participant Flow|Level 4|40g/day
10878831|NCT00454532|OG000|Outcome|Level 1|10g/day
10878832|NCT00454532|OG001|Outcome|Level 2|20g/day
10878833|NCT00454532|OG002|Outcome|Level 3|30g/day
10878834|NCT00454532|OG003|Outcome|Level 4|40g/day
10878835|NCT00454532|EG000|Reported Event|Level 1|10g/day
10878836|NCT00454532|EG001|Reported Event|Level 2|20g/day
10878837|NCT00454532|EG002|Reported Event|Level 3|30g/day
10878838|NCT00454532|EG003|Reported Event|Level 4|40g/day
10878839|NCT00454584|BG000|Baseline|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
10878840|NCT00454584|BG001|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
10878841|NCT00454584|BG002|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
10878842|NCT00454584|BG003|Baseline|Total|Total of all reporting groups
10878843|NCT00454584|FG000|Participant Flow|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
10878844|NCT00454584|FG001|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
10878845|NCT00454584|FG002|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
10878846|NCT00454584|FG003|Participant Flow|Etanercept (After CP)|After Controlled period (Week 12- 64) - receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40
10878847|NCT00454584|FG004|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) - receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
10853543|NCT00319098|BG000|Baseline|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
10853544|NCT00319098|BG001|Baseline|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
10853545|NCT00319098|BG002|Baseline|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
10853546|NCT00319098|BG003|Baseline|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
10853547|NCT00319098|BG004|Baseline|Total|Total of all reporting groups
10853548|NCT00319098|FG000|Participant Flow|GSK1562902A Group|Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.
10853549|NCT00319098|FG001|Participant Flow|Fluarix+Placebo Group|Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.
10853550|NCT00319098|OG000|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
10853551|NCT00319098|OG001|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
10853552|NCT00319098|OG002|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
10853553|NCT00319098|OG003|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
10853554|NCT00319098|EG000|Reported Event|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
11098842|NCT01578317|FG001|Participant Flow|Unadjuvanted|"Administer day 1 and booster at Day 21~H5N1 vaccine without adjuvant: H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart."
10853555|NCT00319098|EG001|Reported Event|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
10853556|NCT00319098|EG002|Reported Event|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
10853557|NCT00319098|EG003|Reported Event|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
10853558|NCT00319111|BG000|Baseline|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
10853559|NCT00319111|FG000|Participant Flow|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
10853560|NCT00319111|OG000|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
10853561|NCT00319111|EG000|Reported Event|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
10853562|NCT00319254|BG000|Baseline|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10853563|NCT00319254|FG000|Participant Flow|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10853564|NCT00319254|OG000|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10853565|NCT00319254|EG000|Reported Event|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10853566|NCT00319436|BG000|Baseline|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
10878848|NCT00454584|FG005|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) - receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
10878849|NCT00454584|OG000|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
11221158|NCT02338973|OG003|Outcome|Subretinal Fluid Volume at Week 2 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221159|NCT02338973|OG004|Outcome|Difference at Week 2 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221160|NCT02338973|OG005|Outcome|Difference at Week 2 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221161|NCT02338973|OG002|Outcome|Subretinal Fluid Volume at Week 5 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221162|NCT02338973|OG003|Outcome|Subretinal Fluid Volume at Week 5 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221163|NCT02338973|OG004|Outcome|Difference at Week 5 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221164|NCT02338973|OG005|Outcome|Difference at Week 5 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221165|NCT02338973|OG002|Outcome|Subretinal Fluid Volume at Week 8 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221166|NCT02338973|OG003|Outcome|Subretinal Fluid Volume at Week 8 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221167|NCT02338973|OG004|Outcome|Difference at Week 8 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221168|NCT02338973|OG005|Outcome|Difference at Week 8 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221169|NCT02338973|OG002|Outcome|Subretinal Fluid Volume at Week 52 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221170|NCT02338973|OG003|Outcome|Subretinal Fluid Volume at Week 52 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221171|NCT02338973|OG004|Outcome|Difference at Week 52 From Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221172|NCT02338973|OG005|Outcome|Difference at Week 52 From Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11343091|NCT03727841|BG000|Baseline|1/Cohort 1 - Participants With Ependymoma Who Had None, One or Two Prior Chemotherapies|"Marizomib at days 1, 8, and 15 of each 28-day cycle~Marizomib: 0.8mg/m(2) intravenous (IV) on days 1, 8, and 15 of each 28-day cycle, 24 cycles total.~Participants with Intra-cranial or Spinal V-Rel Avian Reticuloendotheliosis Viral Oncogene Homolog A (RELA)-fusion Ependymoma who have had none, 1 or 2 prior chemotherapies."
11343092|NCT03727841|BG001|Baseline|2/Cohort 2 - Participants With Ependymoma Who Had More Than Two Prior Chemotherapies|Participants with intra-cranial or spinal RELA-fusion ependymoma who had more than two prior chemotherapies.
11343093|NCT03727841|BG002|Baseline|Total|Total of all reporting groups
11343094|NCT03727841|FG000|Participant Flow|1/Cohort 1 - Participants With Ependymoma Who Had None, One or Two Prior Chemotherapies|"Marizomib at days 1, 8, and 15 of each 28-day cycle~Marizomib: 0.8mg/m(2) intravenous (IV) on days 1, 8, and 15 of each 28-day cycle, 24 cycles total.~Participants with Intra-cranial or Spinal V-Rel Avian Reticuloendotheliosis Viral Oncogene Homolog A (RELA)-fusion Ependymoma who have had none, 1 or 2 prior chemotherapies."
11343095|NCT03727841|FG001|Participant Flow|2/Cohort 2 - Participants With Ependymoma Who Had More Than Two Prior Chemotherapies|Participants with intra-cranial or spinal RELA-fusion ependymoma who had more than two prior chemotherapies.
11343096|NCT03727841|OG000|Outcome|1/Cohort 1 - Participants With Ependymoma Who Had None, One or Two Prior Chemotherapies|"Marizomib at days 1, 8, and 15 of each 28-day cycle~Marizomib: 0.8mg/m(2) intravenous (IV) on days 1, 8, and 15 of each 28-day cycle, 24 cycles total.~Participants with Intra-cranial or Spinal V-Rel Avian Reticuloendotheliosis Viral Oncogene Homolog A (RELA)-fusion Ependymoma who have had none, 1 or 2 prior chemotherapies."
11221173|NCT02338973|OG000|Outcome|Central Retinal Thickness at Baseline in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221174|NCT02338973|OG001|Outcome|Central Retinal Thickness at Baseline in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221175|NCT02338973|OG002|Outcome|Central Retinal Thickness at Day 1 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221176|NCT02338973|OG003|Outcome|Central Retinal Thickness at Day 1 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221177|NCT02338973|OG002|Outcome|Central Retinal Thickness at Day 2 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221178|NCT02338973|OG003|Outcome|Central Retinal Thickness at Day 2 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221179|NCT02338973|OG002|Outcome|Central Retinal Thickness at Day 3 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221180|NCT02338973|OG003|Outcome|Central Retinal Thickness at Day 3 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221181|NCT02338973|OG002|Outcome|Central Retinal Thickness at Week 2 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221182|NCT02338973|OG003|Outcome|Central Retinal Thickness at Week 2 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11343097|NCT03727841|OG001|Outcome|2/Cohort 2 - Participants With Ependymoma Who Had More Than Two Prior Chemotherapies|Participants with intra-cranial or spinal RELA-fusion ependymoma who had more than two prior chemotherapies.
10853567|NCT00319436|BG001|Baseline|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
10853568|NCT00319436|BG002|Baseline|Total|Total of all reporting groups
10853569|NCT00319436|FG000|Participant Flow|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
10853570|NCT00319436|FG001|Participant Flow|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
10853571|NCT00319436|OG000|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
10853572|NCT00319436|OG001|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
10853573|NCT00319436|EG000|Reported Event|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
10878850|NCT00454584|OG001|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
11098843|NCT01578317|OG000|Outcome|AS03 Adjuvanted|"Adminsitered day 1, booster at Day 21~H5N1 vaccine plus AS03 adjuvant: H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart."
11098844|NCT01578317|OG001|Outcome|Unadjuvanted|"Administer day 1 and booster at Day 21~H5N1 vaccine without adjuvant: H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart."
11098845|NCT01578317|EG000|Reported Event|AS03 Adjuvanted|"Adminsitered day 1, booster at Day 21~H5N1 vaccine plus AS03 adjuvant: H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart."
11098846|NCT01578317|EG001|Reported Event|Unadjuvanted|"Administer day 1 and booster at Day 21~H5N1 vaccine without adjuvant: H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart."
11221183|NCT02338973|OG002|Outcome|Central Retinal Thickness at Week 5 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853574|NCT00319436|EG001|Reported Event|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
10853575|NCT00319501|BG000|Baseline|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
11221184|NCT02338973|OG003|Outcome|Central Retinal Thickness at Week 5 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221185|NCT02338973|OG002|Outcome|Central Retinal Thickness at Week 8 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853576|NCT00319501|BG001|Baseline|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
10853577|NCT00319501|BG002|Baseline|Total|Total of all reporting groups
10853578|NCT00319501|FG000|Participant Flow|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
10853579|NCT00319501|FG001|Participant Flow|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
10853580|NCT00319501|OG000|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
10853581|NCT00319501|OG001|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
11221186|NCT02338973|OG003|Outcome|Central Retinal Thickness at Week 8 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
10853582|NCT00319501|OG000|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
10853583|NCT00319501|OG001|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
10853584|NCT00319501|OG000|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
10853585|NCT00319501|EG000|Reported Event|Diazepam (Double-blind Period)|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
10853586|NCT00319501|EG001|Reported Event|Diazepam (Open-label Period)|Participants received an age- and weight-appropriate dose of placebo solution administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed.
10853587|NCT00319501|EG002|Reported Event|Diazepam (Open-label Extension)|Participants continued to receive diazepam in an age- and weight-appropriate dose of administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed at the onset of an ARS episode. Participants were to continue until drug became marketed.
10853588|NCT00319501|EG003|Reported Event|Placebo (Double-blind Period)|Participants received a single dose of diazepam-matching solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
10853589|NCT00319553|BG000|Baseline|Adacel® Vaccine Group|
10853590|NCT00319553|BG001|Baseline|Boostrix® Vaccine Group|
10853591|NCT00319553|BG002|Baseline|Total|Total of all reporting groups
10853592|NCT00319553|FG000|Participant Flow|Adacel® Vaccine Group|
10853593|NCT00319553|FG001|Participant Flow|Boostrix® Vaccine Group|
10853594|NCT00319553|OG000|Outcome|Adacel® Vaccine Group|
10853595|NCT00319553|OG001|Outcome|Boostrix® Vaccine Group|
10853596|NCT00319553|EG000|Reported Event|Adacel® Vaccine Group|
10853597|NCT00319553|EG001|Reported Event|Boostrix® Vaccine Group|
10853598|NCT00319592|BG000|Baseline|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
10853599|NCT00319592|BG001|Baseline|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
10853600|NCT00319592|BG002|Baseline|Total|Total of all reporting groups
10853601|NCT00319592|FG000|Participant Flow|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
10853602|NCT00319592|FG001|Participant Flow|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
10853603|NCT00319592|OG000|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
10853604|NCT00319592|OG001|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
10853605|NCT00319592|EG000|Reported Event|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
10853606|NCT00319592|EG001|Reported Event|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
10853607|NCT00319644|BG000|Baseline|Minibal Arm|Using Mini bronchoalveolar lavage
10853608|NCT00319644|BG001|Baseline|Tracheal Aspirates|No intervention. Standard of care in ICU.
10853609|NCT00319644|BG002|Baseline|Total|Total of all reporting groups
10853610|NCT00319644|FG000|Participant Flow|Tracheal Aspirates|No intervention. Standard of care in ICU.
10853611|NCT00319644|FG001|Participant Flow|Minibal Arm|Using Mini bronchoalveolar lavage
10853612|NCT00319644|OG000|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
10853613|NCT00319644|OG001|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
10853614|NCT00319644|EG000|Reported Event|Minibal Arm|Using Mini bronchoalveolar lavage
10853615|NCT00319644|EG001|Reported Event|Tracheal Aspirates|No intervention. Standard of care in ICU.
10853616|NCT00319696|BG000|Baseline|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
10853617|NCT00319696|FG000|Participant Flow|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
10853618|NCT00319696|OG000|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
10853619|NCT00319696|OG000|Outcome|0 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
10853620|NCT00319696|OG001|Outcome|At Least 1 New Ulcer|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
10853621|NCT00319696|OG002|Outcome|At Least 2 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
10853622|NCT00319696|OG003|Outcome|At Least 3 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
10853623|NCT00319696|OG004|Outcome|At Least 4 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
10853624|NCT00319696|OG005|Outcome|At Least 5 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
10853625|NCT00319696|EG000|Reported Event|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
10853626|NCT00319735|BG000|Baseline|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
10853627|NCT00319735|FG000|Participant Flow|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
10853628|NCT00319735|OG000|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
10878851|NCT00454584|OG002|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
10853629|NCT00319735|OG000|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
10853630|NCT00319735|EG000|Reported Event|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
10853631|NCT00319748|BG000|Baseline|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
10853632|NCT00319748|FG000|Participant Flow|Patients Treated With 852A|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
11221187|NCT02338973|OG002|Outcome|Central Retinal Thickness at Week 52 in Study Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221188|NCT02338973|OG003|Outcome|Central Retinal Thickness at Week 52 in Fellow Eye|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221189|NCT02338973|EG000|Reported Event|Interferon Gamma-1b|"Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks~Interferon gamma-1b"
11221190|NCT02338999|BG000|Baseline|Pioglitazone, Then Placebo|Treatment with pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for three months. Followed by a two-month washout period before cross over to placebo treatment for 3 months.
10853633|NCT00319748|OG000|Outcome|Patients With Ovarian Cancer|Participants with ovarian cancer who received all 24 doses of 852A.
10853634|NCT00319748|OG000|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IL1ra in patients treated with 852A.
10853635|NCT00319748|OG000|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IP-10 in patients treated with 852A.
10853636|NCT00319748|OG000|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for Macrophage Inflammatory Protein-1 Alpha (cytokine) level in patients treated with 852A.
10853637|NCT00319748|OG000|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of MIP-1b in patients treated with 852A.
10853638|NCT00319748|OG000|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of sCD40L in patients treated with 852A.
10853639|NCT00319748|OG000|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of TNF-a in patients treated with 852A.
10853640|NCT00319748|EG000|Reported Event|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
10853641|NCT00319956|BG000|Baseline|Azith Group|Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
10853642|NCT00319956|BG001|Baseline|Placebo Group|D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
10853643|NCT00319956|BG002|Baseline|Total|Total of all reporting groups
10853644|NCT00319956|FG000|Participant Flow|Azith Group|Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
10853645|NCT00319956|FG001|Participant Flow|Placebo Group|D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
10853646|NCT00319956|OG000|Outcome|Azith Group|Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
11221191|NCT02338999|BG001|Baseline|Placebo, Then Pioglitazone|Treatment with placebo for 3 months. Followed by a 2-month washout period before cross over to pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for an additional 3 months.
11221192|NCT02338999|BG002|Baseline|Total|Total of all reporting groups
11221193|NCT02338999|FG000|Participant Flow|Pioglitazone, Then Placebo|Treatment with pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for three months. Followed by a two-month washout period before cross over to placebo treatment for 3 months.
11221194|NCT02338999|FG001|Participant Flow|Placebo, Then Pioglitazone|Treatment with placebo for 3 months. Followed by a 2-month washout period before cross over to pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for an additional 3 months.
11221195|NCT02338999|OG000|Outcome|Pioglitazone, Then Placebo|Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
11221196|NCT02338999|OG001|Outcome|Placebo, Then Pioglitazone|Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
11221197|NCT02338999|EG000|Reported Event|Pioglitazone|Treatment with pioglitazone up to 45 mg orally daily for three months.
10853647|NCT00319956|OG001|Outcome|Placebo Group|D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
10853648|NCT00319956|EG000|Reported Event|Azith Group|Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
10853649|NCT00319956|EG001|Reported Event|Placebo Group|D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
10853650|NCT00319982|BG000|Baseline|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
10853651|NCT00319982|BG001|Baseline|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
10853652|NCT00319982|BG002|Baseline|Total|Total of all reporting groups
10853653|NCT00319982|FG000|Participant Flow|I- Diltiazem (Active Arm)|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
10853654|NCT00319982|FG001|Participant Flow|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
10853655|NCT00319982|OG000|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
11221198|NCT02338999|EG001|Reported Event|Placebo|Treatment with placebo orally daily for 3 months.
11221199|NCT02339038|BG000|Baseline|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
11221200|NCT02339038|FG000|Participant Flow|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
11221201|NCT02339038|OG000|Outcome|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
11221202|NCT02339038|EG000|Reported Event|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
11221203|NCT02339155|BG000|Baseline|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
11221204|NCT02339155|BG001|Baseline|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
11221205|NCT02339155|BG002|Baseline|Total|Total of all reporting groups
11221206|NCT02339155|FG000|Participant Flow|AVA Alone|Participants administered Anthrax vaccine adsorbed (AVA) subcutaneous (SC) 0.5 milliliter (mL) on Days 1, 15 and 29
11221207|NCT02339155|FG001|Participant Flow|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29. with the first AVA dose administered immediately after completion of a single 40 milligram/kilogram (mg/kg) intravenous (IV) infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
11221208|NCT02339155|OG000|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
10853656|NCT00319982|OG001|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
10853657|NCT00319982|EG000|Reported Event|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
10853658|NCT00319982|EG001|Reported Event|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
10853659|NCT00320112|BG000|Baseline|Receiprocal Peer Support|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
10853660|NCT00320112|BG001|Baseline|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
10853661|NCT00320112|BG002|Baseline|Total|Total of all reporting groups
10853662|NCT00320112|FG000|Participant Flow|Reciprocal Diabetes Peer Support Program (RPS)|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
10853663|NCT00320112|FG001|Participant Flow|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts. particpants were also provided information about nurse case managements services and encouraged to use the service regularly.
10878852|NCT00454584|OG000|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
11221209|NCT02339155|OG001|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
11221210|NCT02339155|OG001|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29. with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
11221211|NCT02339155|EG000|Reported Event|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
10853664|NCT00320112|OG000|Outcome|Reciprocal Peer Support Group|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
11221212|NCT02339155|EG001|Reported Event|Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion|During the study, six of 286 raxibacumab-treated subjects (2.1%) had adverse events (AEs) to raxibacumab that required drug discontinuation, administration of additional medications for mitigation of signs and symptoms, and discontinuation from the study. This new arm is included to capture safety data for these 6 subjects.
11221213|NCT02339155|EG002|Reported Event|AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
11221214|NCT02339246|BG000|Baseline|Prograf vs Envarsus XR vs Astagraf XL|"Prograft capsules Twice daily Envarsus XR tablets once daily Astagraf XL capsules once daily~Prograf vs Envarsus XR vs Astagraf XL: prograf vs Envarsus XR vs Astagraf XL"
10853665|NCT00320112|OG001|Outcome|Nurse Case Management Group|Nurse Case Management group was offered an educational session with nurse case managers on diabetes and informed of case management services. they were encouraged to utilize this service regularly.
10853666|NCT00320112|OG000|Outcome|Change in Systolic BP at 6 Months for Peer Support Group|change in systolic blood pressure from baseline to six months among participants in the peer support group
10853667|NCT00320112|OG001|Outcome|Change in Systsolic at 6 Months for Nurse Mgt Group|change in systolic blood pressure from baseline to six months in the nurse case management group
10853668|NCT00320112|OG000|Outcome|Reciprocal Peer Support Group|participants are age-matched with a peer and asked to talk with each other weekly using a telephone support sytem
10853669|NCT00320112|OG001|Outcome|Nurse Case Management Group|participants in the nurse case management group receive initial educational session on diabetes and information bout case management services. they are encouraged to contact their nurse case manager regularly.
11221215|NCT02339246|BG001|Baseline|Prograf vs Astagraf XL vs Envarsus XR|"Prograf capsules twice daily Astagraf XL capsules once daily Envarsus XR tablets once daily~Prograf vs Astagraf XL vs Envarsus XR: Prograf vs Astagraf XL vs Envarsus XR"
11221216|NCT02339246|BG002|Baseline|Total|Total of all reporting groups
11221217|NCT02339246|FG000|Participant Flow|Envarsus XR|Envarsus XR tablets once daily.
11221218|NCT02339246|FG001|Participant Flow|Astagraf XL|Astagraf XL capsules once daily.
11221219|NCT02339246|FG002|Participant Flow|Prograf|Prograf capsules twice daily.
11221220|NCT02339246|OG000|Outcome|Envarsus XR|Envarsus XR tablets once daily.
11221221|NCT02339246|OG001|Outcome|Astagraf XL|Astagraf XL capsules once daily.
11221222|NCT02339246|OG002|Outcome|Prograf|Prograf capsules twice daily.
11221223|NCT02339246|EG000|Reported Event|Envarsus XR|Envarsus XR tablets once daily.
11221224|NCT02339246|EG001|Reported Event|Astagraf XR|Astagraf XR capsules once daily.
10853670|NCT00320112|OG000|Outcome|Reciprocal Peer Support Group|patients were age-matched and assigned to a peer. they were asked to make weekly calls using a telephone support system to check in and discuss their diabetes
10853671|NCT00320112|OG001|Outcome|Nurse Case Management Grouop|patients were provided an educational session and discussed nurse case management services. participants were encouraged to meet wit their case manager regularly.
10853672|NCT00320112|EG000|Reported Event|Reciprocal Peer Support Intervention|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
10853673|NCT00320112|EG001|Reported Event|Nurse Case Management Intervention|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
10853674|NCT00320190|BG000|Baseline|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
11221225|NCT02339246|EG002|Reported Event|Prograf|Prograf capsules twice daily.
11221226|NCT02339285|BG000|Baseline|tACS (Alpha)|10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
11221227|NCT02339285|BG001|Baseline|tACS (Gamma)|40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
11221228|NCT02339285|BG002|Baseline|Sham Stimulation|Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
11221229|NCT02339285|BG003|Baseline|Total|Total of all reporting groups
11221230|NCT02339285|FG000|Participant Flow|tACS (Alpha)|10 Hz transcranial alternating current stimulation (tACS) with a peak-to-peak amplitude of 2 mA for 40 minutes
11221231|NCT02339285|FG001|Participant Flow|tACS (Gamma)|40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
11221232|NCT02339285|FG002|Participant Flow|Sham Stimulation|Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
11221233|NCT02339285|OG000|Outcome|tACS (Alpha)|10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
11221234|NCT02339285|OG001|Outcome|tACS (Gamma)|40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
11221235|NCT02339285|OG002|Outcome|Sham Stimulation|Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
11221236|NCT02339285|EG000|Reported Event|tACS (Alpha)|10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
10853675|NCT00320190|BG001|Baseline|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
10853676|NCT00320190|BG002|Baseline|Total|Total of all reporting groups
10853677|NCT00320190|FG000|Participant Flow|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
10853678|NCT00320190|FG001|Participant Flow|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
10853679|NCT00320190|OG000|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
10853680|NCT00320190|OG001|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
10853681|NCT00320190|EG000|Reported Event|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
10853682|NCT00320190|EG001|Reported Event|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily
10853683|NCT00320216|BG000|Baseline|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
10853684|NCT00320216|BG001|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
10853685|NCT00320216|BG002|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
10853686|NCT00320216|BG003|Baseline|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
10853687|NCT00320216|BG004|Baseline|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
10853688|NCT00320216|BG005|Baseline|Total|Total of all reporting groups
10853689|NCT00320216|FG000|Participant Flow|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
10853690|NCT00320216|FG001|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
10853691|NCT00320216|FG002|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
10853692|NCT00320216|FG003|Participant Flow|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
10853693|NCT00320216|FG004|Participant Flow|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
10853694|NCT00320216|OG000|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
10853695|NCT00320216|OG001|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
10853696|NCT00320216|OG002|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
10853697|NCT00320216|OG003|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
10853698|NCT00320216|OG004|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
10853699|NCT00320216|EG000|Reported Event|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
10853700|NCT00320216|EG001|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
10853701|NCT00320216|EG002|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
10853702|NCT00320216|EG003|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
10853703|NCT00320216|EG004|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
10853704|NCT00320216|EG005|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving placebo at Weeks 0, 1, 2, 3 and 16 -> receiving ustekinumab 90 mg at Week 20.
10853705|NCT00320216|EG006|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
10853706|NCT00320216|EG007|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
10853707|NCT00320216|EG008|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
11098847|NCT01578330|BG000|Baseline|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
11221237|NCT02339285|EG001|Reported Event|tACS (Gamma)|40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
11221238|NCT02339285|EG002|Reported Event|Sham Stimulation|Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
11221239|NCT02339389|BG000|Baseline|Study Group|"We are simply measuring ventilation changes that occur following labor analgesia.~Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline"
11221240|NCT02339389|FG000|Participant Flow|Study Group|Maternal ventilation was measured non-invasively using the ExSpiron Respiratory Volume Monitor (RVM) in forty-one term parturients who received labor epidural analgesia. Minute ventilation (MV), respiratory rate (RR), and tidal volume (TV) were measured via chest pads using bio-impedance technology. In addition, we recorded vital signs and maternal oral temperature at 5, 10, 15, 20, 25, 30 and 60 min after epidural analgesia initiation, and then every hour until delivery.
11221241|NCT02339389|OG000|Outcome|Study Group|Maternal ventilation was measured non-invasively using the ExSpiron Respiratory Volume Monitor (RVM) in forty-one term parturients who received labor epidural analgesia. Minute ventilation (MV), respiratory rate (RR), and tidal volume (TV) were measured via chest pads using bio-impedance technology. In addition, we recorded vital signs and maternal oral temperature at 5, 10, 15, 20, 25, 30 and 60 min after epidural analgesia initiation, and then every hour until delivery.
11221242|NCT02339389|OG000|Outcome|Ventilation During Labor Analgesia|"We are simply measuring ventilation changes that occur following labor analgesia.~Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline"
11098848|NCT01578330|FG000|Participant Flow|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
11098849|NCT01578330|OG000|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
11098850|NCT01578330|EG000|Reported Event|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
11098851|NCT01578486|BG000|Baseline|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
11098852|NCT01578486|FG000|Participant Flow|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
11098853|NCT01578486|OG000|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
11098854|NCT01578486|EG000|Reported Event|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
11098855|NCT01578499|BG000|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
11098856|NCT01578499|BG001|Baseline|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
11098857|NCT01578499|BG002|Baseline|Total|Total of all reporting groups
11098858|NCT01578499|FG000|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
11098859|NCT01578499|FG001|Participant Flow|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
11098860|NCT01578499|OG000|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
11098861|NCT01578499|OG001|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
11098862|NCT01578499|OG000|Outcome|pcALCL: Brentuximab Vedotin|Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
11098863|NCT01578499|OG001|Outcome|MF: Brentuximab Vedotin 1.8 mg/kg|Participants with mycosis fungoides (MF) received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
11098864|NCT01578499|OG000|Outcome|pcALCL: Brentuximab Vedotin|Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
11098865|NCT01578499|OG001|Outcome|MF: Brentuximab Vedotin 1.8 mg/kg|Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
11098866|NCT01578499|EG000|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
11098867|NCT01578499|EG001|Reported Event|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
11126264|NCT01784848|FG001|Participant Flow|Clinical Treatment|"Optimized clinical treatment including medical management of hypertension.~Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction."
11126265|NCT01784848|OG000|Outcome|Laparoscopic Roux-en-Y Gastric Bypass|"Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.~Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery~Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction."
10975789|NCT00937521|OG000|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
11343098|NCT03727841|EG000|Reported Event|1/Cohort 1 - Participants With Ependymoma Who Had None, One or Two Prior Chemotherapies|"Marizomib at days 1, 8, and 15 of each 28-day cycle~Marizomib: 0.8mg/m(2) intravenous (IV) on days 1, 8, and 15 of each 28-day cycle, 24 cycles total.~Participants with Intra-cranial or Spinal V-Rel Avian Reticuloendotheliosis Viral Oncogene Homolog A (RELA)-fusion Ependymoma who have had none, 1 or 2 prior chemotherapies."
11343099|NCT03727841|EG001|Reported Event|2/Cohort 2 - Participants With Ependymoma Who Had More Than Two Prior Chemotherapies|Participants with intra-cranial or spinal RELA-fusion ependymoma who had more than two prior chemotherapies.
11343100|NCT03736967|BG000|Baseline|Placebo Q2W|Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11343101|NCT03736967|BG001|Baseline|REGN3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11343102|NCT03736967|BG002|Baseline|Dupilumab 300 mg Q2W|Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.
11343103|NCT03736967|BG003|Baseline|REGN3500 300 mg + Dupilumab 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.
11343104|NCT03736967|BG004|Baseline|Total|Total of all reporting groups
11343105|NCT03736967|FG000|Participant Flow|Placebo Q2W|Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11343106|NCT03736967|FG001|Participant Flow|REGN3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11343107|NCT03736967|FG002|Participant Flow|Dupilumab 300 mg Q2W|Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.
11343108|NCT03736967|FG003|Participant Flow|REGN3500 300 mg + Dupilumab 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.
11343109|NCT03736967|OG000|Outcome|Placebo Q2W|Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11343110|NCT03736967|OG001|Outcome|REGN3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11343111|NCT03736967|OG002|Outcome|Dupilumab 300 mg Q2W|Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.
11343112|NCT03736967|OG003|Outcome|REGN3500 300 mg + Dupilumab 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.
11343113|NCT03736967|OG000|Outcome|REGN3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11343114|NCT03736967|OG001|Outcome|REGN3500 300 mg + Dupilumab 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.
11343115|NCT03736967|OG000|Outcome|Dupilumab 300 mg Q2W|Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.
11343116|NCT03736967|EG000|Reported Event|Placebo Q2W|Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11343117|NCT03736967|EG001|Reported Event|R3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
11221243|NCT02339389|EG000|Reported Event|Ventilation During Labor Analgesia|"We are simply measuring ventilation changes that occur following labor analgesia.~Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline"
11221244|NCT02339415|BG000|Baseline|Placebo First Then Edoxaban|Participants receive placebo during first period, then Edoxaban (30mg daily) in second period after washout.
11343118|NCT03736967|EG002|Reported Event|Dupilumab 300 mg Q2W|Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.
11343119|NCT03736967|EG003|Reported Event|R3500 300 mg and Dupilumab 300 mg Q2W|Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.
11343120|NCT03739840|BG000|Baseline|Placebo|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, twice daily (bid) up to Week 19.
11343121|NCT03739840|BG001|Baseline|Padsevonil 100 mg BID|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.
11343122|NCT03739840|BG002|Baseline|Padsevonil 200 mg BID|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.
11343123|NCT03739840|BG003|Baseline|Padsevonil 400 mg BID|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19
11343124|NCT03739840|BG004|Baseline|Total Title|
11343125|NCT03739840|FG000|Participant Flow|Placebo|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, twice daily (bid) up to Week 19.
11343126|NCT03739840|FG001|Participant Flow|Padsevonil 100 mg BID|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.
11343127|NCT03739840|FG002|Participant Flow|Padsevonil 200 mg BID|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.
11343128|NCT03739840|FG003|Participant Flow|Padsevonil 400 mg BID|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19
11343129|NCT03739840|OG000|Outcome|Placebo (FAS)|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).
11343130|NCT03739840|OG001|Outcome|Padsevonil 100 mg BID (FAS)|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
11343131|NCT03739840|OG002|Outcome|Padsevonil 200 mg BID (FAS)|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
11343132|NCT03739840|OG003|Outcome|Padsevonil 400 mg BID (FAS)|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
11343133|NCT03739840|OG000|Outcome|Placebo (SS)|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Safety Set (SS).
11343134|NCT03739840|OG001|Outcome|Padsevonil 100 mg BID (SS)|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
11343135|NCT03739840|OG002|Outcome|Padsevonil 200 mg BID (SS)|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
11343136|NCT03739840|OG003|Outcome|Padsevonil 400 mg BID (SS)|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
11343137|NCT03739840|EG000|Reported Event|Placebo Treatment Period (SS)|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Safety Set (SS).
11343138|NCT03739840|EG001|Reported Event|Padsevonil 100 mg BID Treatment Period (SS)|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
11343139|NCT03739840|EG002|Reported Event|Padsevonil 200 mg BID Treatment Period (SS)|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
11343140|NCT03739840|EG003|Reported Event|Padsevonil 400 mg BID Treatment Period (SS)|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
11221245|NCT02339415|BG001|Baseline|Edoxaban First Then Placebo|Participants receive Edoxaban (30mg daily) in first period, then placebo during second period after washout.
11221246|NCT02339415|BG002|Baseline|Total|Total of all reporting groups
11221247|NCT02339415|FG000|Participant Flow|Placebo First Then Edoxaban|Participants receive placebo during first period, then Edoxaban (30mg daily) in second period after washout.
11221248|NCT02339415|FG001|Participant Flow|Edoxaban First Then Placebo|Participants receive Edoxaban (30mg daily) in first period, then placebo during second period after washout.
11343141|NCT03739840|EG004|Reported Event|Placebo Conversion Period (SS)|A 3-Week Conversion Period was required for study participants who chose to enroll in the open-label extension (OLE) study at the end of the 12-Week Maintenance Period. Participants initially randomized to placebo progressively received padsevonil in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the Safety Set (SS).
10853708|NCT00320216|EG009|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
10853709|NCT00320242|BG000|Baseline|All Study Participants Who Completed Protocol|This analysis includes all study participants who completed the protocol (n = 26)
10853710|NCT00320242|FG000|Participant Flow|1 mo Baseline Before Visual Cue|1 mo baseline using the cane/walker without the laserlight visual cue, followed by additional time using the visual cue
10853711|NCT00320242|FG001|Participant Flow|2 Month Baseline Before Visual Cue|2 month baseline using the laserlight visual cue, followed by 1 additional month using the laserlight visual cue. This group served as an active comparator control for comparison with Group 1during the 2nd month, when group 1 did use the visual cue but group 2 continued without the visual cue.
10853712|NCT00320242|OG000|Outcome|1 Month Baseline Before Use of Laserlight Visual Cue|subjects had a 1 month baseline before use of laserlight visual cue
10853713|NCT00320242|OG000|Outcome|All Study Participants Who Completed Protocol|All 26 subjects who entered the study and completed the study protocol.
10853714|NCT00320242|OG000|Outcome|All Study Participants Who Completed Protocol|All 26 Study Participants who completed protocol. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue.
10853715|NCT00320242|OG000|Outcome|1 or 2 Month Baseline Before Use of Laserlight Visual Cue|subjects had a 1 month baseline before use of laserlight visual cue
10853716|NCT00320242|EG000|Reported Event|All Study Participants|
10853717|NCT00320255|BG000|Baseline|Cohort 1: Placebo|Participants received placebo tablets once daily
10853718|NCT00320255|BG001|Baseline|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
10853719|NCT00320255|BG002|Baseline|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
10853720|NCT00320255|BG003|Baseline|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
10853721|NCT00320255|BG004|Baseline|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
10853722|NCT00320255|BG005|Baseline|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
10853723|NCT00320255|BG006|Baseline|Total|Total of all reporting groups
10853724|NCT00320255|FG000|Participant Flow|Cohort 1: Placebo|Participants received placebo tablets once daily
10853725|NCT00320255|FG001|Participant Flow|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
10853726|NCT00320255|FG002|Participant Flow|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
10853727|NCT00320255|FG003|Participant Flow|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
10853728|NCT00320255|FG004|Participant Flow|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
10853729|NCT00320255|FG005|Participant Flow|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
10853730|NCT00320255|OG000|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
11221249|NCT02339415|OG000|Outcome|Placebo|Matched placebo
10853731|NCT00320255|OG001|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
10853732|NCT00320255|OG002|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
10853733|NCT00320255|OG003|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
10853734|NCT00320255|OG004|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
10853735|NCT00320255|OG005|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
10853736|NCT00320255|OG005|Outcome|Cohort 2: Apixiban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
10853737|NCT00320255|EG000|Reported Event|Cohort 1: Placebo|Participants received placebo tablets once daily
10853738|NCT00320255|EG001|Reported Event|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
10853739|NCT00320255|EG002|Reported Event|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
10853740|NCT00320255|EG003|Reported Event|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
10853741|NCT00320255|EG004|Reported Event|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
10853742|NCT00320255|EG005|Reported Event|Cohort : Apixaban, 5 mg|:Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
10853743|NCT00320281|BG000|Baseline|Group 1-Botox A Group|This group received the active drug, botox a injections.
10853744|NCT00320281|BG001|Baseline|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
10853745|NCT00320281|BG002|Baseline|Total|Total of all reporting groups
10853746|NCT00320281|FG000|Participant Flow|Group 1-Botox A Group|This group received the active drug, botox a injections.
10853747|NCT00320281|FG001|Participant Flow|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
10853748|NCT00320281|OG000|Outcome|Group 1-Botox A Group|Those randomized to this treatment group received injections based on treatment plan designed by PI and study physical therapist. Botulism toxin A was diluted in 25 cc of saline for the injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
10853749|NCT00320281|OG001|Outcome|Group 2-saline Group|Those randomized to this treatment group received injections based on treatment plan devised by study PI and study physical therapist. 25 cc of saline were used for these injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
10853750|NCT00320281|OG000|Outcome|Group 1 - Botox A|
10853751|NCT00320281|OG001|Outcome|Group 2 - Saline Group|
10853752|NCT00320281|EG000|Reported Event|Group 1-Botox A Group|This group received the active drug, botox a injections.
10853753|NCT00320281|EG001|Reported Event|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
10853754|NCT00320372|BG000|Baseline|VNS Therapy D-23 Original|Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm.
10853755|NCT00320372|BG001|Baseline|VNS Therapy D-21 Rollover|Subjects that entered the TRD Registry, having previously participated in the D-21 study and still being treated with VNS Therapy treatment were included within the VNS Therapy group. Based on the duration from initial implant to enrollment date, the D-21 rollover patients entered at the appropriate D-23 follow-up interval (i.e., patient enrolls at 24 months post implant for their first D-23 follow up visit. This 24 month visit corresponds to the 24 month follow up in the TRD Registry). Starting with the first TRD Registry visit, the D-21 long-term patients were to follow the same data collection schedule as other Original VNS and TAU Registry patients.
10853756|NCT00320372|BG002|Baseline|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy. Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
10853757|NCT00320372|BG003|Baseline|Total|Total of all reporting groups
10853758|NCT00320372|FG000|Participant Flow|VNS Therapy|Disposition of study patients from baseline to the end of the study. The VNS Therapy arm, was comprised of D-23 Original patients (Patients that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm) and D-21 Rollover patients (Patients that entered the TRD Registry, having previously participated in the D-21 study-NCT00305565 and still being treated with VNS Therapy).
10853759|NCT00320372|FG001|Participant Flow|Treatment as Usual (TAU)|Disposition of study patients from baseline to the end of the study. The TAU arm were subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
10853760|NCT00320372|OG000|Outcome|VNS Therapy|MADRS % Responders (Percentage of Responders)
10853761|NCT00320372|OG001|Outcome|Treatment As Usual (TAU)|MADRS % Responders (Percentage of Responders)
10853762|NCT00320372|OG000|Outcome|VNS Therapy|Time until recurrence based on the MADRS
10853763|NCT00320372|OG001|Outcome|Treatment As Usual (TAU)|Time until recurrence based on the MADRS
10853764|NCT00320372|OG000|Outcome|VNS Therapy|MADRS % Remitters (Percentage of Subjects in Remission)
10853765|NCT00320372|OG001|Outcome|Treatment As Usual (TAU)|MADRS % Remitters (Percentage of Subjects in Remission)
10853766|NCT00320372|OG000|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
10853767|NCT00320372|OG001|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
10853768|NCT00320372|OG000|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
10853769|NCT00320372|OG000|Outcome|VNS Therapy|Change from Baseline Score
10853770|NCT00320372|OG001|Outcome|Treatment As Usual (TAU)|Change from Baseline Score
10853771|NCT00320372|EG000|Reported Event|Safety Events|N/A (not collected)
10853772|NCT00320385|BG000|Baseline|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
10853773|NCT00320385|BG001|Baseline|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
10853774|NCT00320385|BG002|Baseline|Total|Total of all reporting groups
10853775|NCT00320385|FG000|Participant Flow|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
10853776|NCT00320385|FG001|Participant Flow|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
10853777|NCT00320385|OG000|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
10853778|NCT00320385|OG001|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
10853779|NCT00320385|EG000|Reported Event|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
11343142|NCT03739840|EG005|Reported Event|Padsevonil 100 mg BID Conversion Period (SS)|A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 100 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.
11343143|NCT03739840|EG006|Reported Event|Padsevonil 200 mg BID Conversion Period (SS)|A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 200 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.
11343144|NCT03739840|EG007|Reported Event|Padsevonil 400 mg BID Conversion Period (SS)|A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 400 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.
11343145|NCT03739840|EG008|Reported Event|Placebo Taper and SFU Period (SS)|A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to placebo group received 5-6 placebo tablets to maintain the blinding and have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the Safety Set (SS).
11343146|NCT03739840|EG009|Reported Event|Padsevonil 100 mg BID Taper and SFU Period (SS)|A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 100 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
11343147|NCT03739840|EG010|Reported Event|Padsevonil 200 mg BID Taper and SFU Period (SS)|A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 200 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
11343148|NCT03739840|EG011|Reported Event|Padsevonil 400 mg BID Taper and SFU Period (SS)|A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 400 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
11343149|NCT03739983|BG000|Baseline|VRP Therapy|"All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.~Vaginal Renewal Program: Therapeutic vibrating wand."
11343150|NCT03739983|FG000|Participant Flow|VRP Therapy|"All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.~Vaginal Renewal Program: Therapeutic vibrating wand."
11343151|NCT03739983|OG000|Outcome|VRP Therapy|All subjects on this study will receive the Vaginal Renewal Program (VRP) intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.
11343152|NCT03739983|EG000|Reported Event|VRP Therapy|"All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.~Vaginal Renewal Program: Therapeutic vibrating wand."
11343153|NCT03746002|BG000|Baseline|Metolazone Pre-dosing|"Metolazone 5 mg by mouth administered 60 minutes prior to furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)~Metolazone 60 minutes prior to furosemide: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide."
11343154|NCT03746002|BG001|Baseline|Metolazone Concurrent Dosing|"Metolazone 5 mg by mouth administered at the same time as furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)~Metolazone concurrently with furosemide: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide."
11343155|NCT03746002|BG002|Baseline|Total|Total of all reporting groups
11343156|NCT03746002|FG000|Participant Flow|Metolazone Pre-dosing|"Metolazone 5 mg by mouth administered 60 minutes prior to furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)~Metolazone 60 minutes prior to furosemide: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide."
11221250|NCT02339415|OG001|Outcome|Edoxaban|30mg of Edoxaban
11221251|NCT02339415|OG000|Outcome|Receiving Placebo|Administered matched placebo
11221252|NCT02339415|OG001|Outcome|Receiving Edoxaban|Administered 30mg of Edoxaban
11221253|NCT02339415|EG000|Reported Event|Placebo|Matched placebo
11221254|NCT02339415|EG001|Reported Event|Edoxaban|30mg of Edoxaban
11221255|NCT02339506|BG000|Baseline|Healthy Control|
10853780|NCT00320385|EG001|Reported Event|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
10853781|NCT00320398|BG000|Baseline|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853782|NCT00320398|BG001|Baseline|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
11221256|NCT02339506|FG000|Participant Flow|Placebo (Period 1)/Washout (Period 2)/Cosyntropin (Period 3)|"Period 1: Subjects will receive a placebo infusion for two sessions of 2.5 hours each on day 2 of their first three day admission to our research center.~Period 2: Washout for one month Period 3: Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of their second three day admission to our research center."
11221257|NCT02339506|FG001|Participant Flow|Cosyntropin (Period 1)/Washout (Period 2)/ Placebo (Period 3)|"Period 1: Subjects will receive a cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of their first three day admission to our research center.~Period 2: Washout for one month Period 3: Subjects will receive a placebo infusion for two sessions of 2.5 hours each on day 2 of their second three day admission to our research center."
11221258|NCT02339506|OG000|Outcome|Cosyntropin|"Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.~Cosyntropin: Subjects will receive cosyntropin at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center."
11221259|NCT02339506|OG001|Outcome|Normal Saline (Placebo)|"Subjects will receive normal saline infusion for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.~Placebo: Subjects will receive placebo (normal saline infusion) for two sessions of 2.5 hours each on day 2 of a three day admission to our research center."
11221260|NCT02339506|EG000|Reported Event|Placebo|
11221261|NCT02339506|EG001|Reported Event|Cosyntropin|
11221262|NCT02339545|BG000|Baseline|Coronary Flow Reserve|Single arm - all enrolled subjects had successful coronary revascularization via orbital atherectomy and stenting.
11221263|NCT02339545|FG000|Participant Flow|Coronary Flow Reserve|Single arm - all enrolled subjects had successful coronary revascularization via orbital atherectomy and stenting.
11221264|NCT02339545|OG000|Outcome|All Eligible Subjects|All subjects whose Doppler flow measurements facilitated calculation of coronary flow reserve
11221265|NCT02339545|OG000|Outcome|All Enrolled Subjects|All subjects who have had successful revascularization by orbital atherectomy and stenting
11221266|NCT02339545|EG000|Reported Event|All Enrolled Subjects|All subjects who have had successful revascularization by orbital atherectomy and stenting
11221267|NCT02339558|BG000|Baseline|Treatment (Nivolumab)|Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
11221268|NCT02339558|FG000|Participant Flow|Treatment (Nivolumab)|Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10853783|NCT00320398|BG002|Baseline|Total|Total of all reporting groups
10853784|NCT00320398|FG000|Participant Flow|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 milligram (mg) administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10878853|NCT00454584|OG001|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
11221269|NCT02339558|OG000|Outcome|Treatment (Nivolumab)|Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
11221270|NCT02339558|EG000|Reported Event|Treatment (Nivolumab)|Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
11221271|NCT02339584|BG000|Baseline|Brinz/Brim|Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
11221272|NCT02339584|BG001|Baseline|Brinz+Brim|Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
11221273|NCT02339584|BG002|Baseline|Total|Total of all reporting groups
11221274|NCT02339584|FG000|Participant Flow|Brinz/Brim|Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
10853785|NCT00320398|FG001|Participant Flow|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853786|NCT00320398|OG000|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853787|NCT00320398|OG001|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853788|NCT00320398|OG000|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853789|NCT00320398|EG000|Reported Event|Fondaparinux 1.5 mg|Eligible participants in this arm received Fondaparinux at 1.5 milligram (mg) administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853790|NCT00320398|EG001|Reported Event|Fondaparinux 2.5 mg|Eligible participants in this arm received Fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11- 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or - 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853791|NCT00320411|BG000|Baseline|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
10853792|NCT00320411|FG000|Participant Flow|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
11221275|NCT02339584|FG001|Participant Flow|Brinz+Brim|Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
11221276|NCT02339584|OG000|Outcome|Brinz/Brim|Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
11221277|NCT02339584|OG001|Outcome|Brinz+Brim|Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
11221278|NCT02339584|EG000|Reported Event|Brinz/Brim|All subjects exposed to Brinz/Brim
11221279|NCT02339584|EG001|Reported Event|Brinz+Brim|All subjects exposed to Brinz+Brim
11221280|NCT02339831|BG000|Baseline|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
11221281|NCT02339831|BG001|Baseline|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
11221282|NCT02339831|BG002|Baseline|Total|Total of all reporting groups
11221283|NCT02339831|FG000|Participant Flow|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
11221284|NCT02339831|FG001|Participant Flow|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
10853793|NCT00320411|OG000|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
10853794|NCT00320411|EG000|Reported Event|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
10853795|NCT00320424|BG000|Baseline|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853796|NCT00320424|FG000|Participant Flow|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 milligrams (mg) by subcutaneous (s.c.) injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853797|NCT00320424|OG000|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
10853798|NCT00320424|EG000|Reported Event|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
11221285|NCT02339831|OG000|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
10853799|NCT00320489|BG000|Baseline|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
10853800|NCT00320489|BG001|Baseline|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
10853801|NCT00320489|BG002|Baseline|Total|Total of all reporting groups
10853802|NCT00320489|FG000|Participant Flow|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
10853803|NCT00320489|FG001|Participant Flow|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
10853804|NCT00320489|OG000|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
10853805|NCT00320489|OG001|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
10853806|NCT00320489|EG000|Reported Event|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
10853807|NCT00320489|EG001|Reported Event|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
10853808|NCT00320515|BG000|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
10853809|NCT00320515|FG000|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
10853810|NCT00320515|OG000|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
10853811|NCT00320515|EG000|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
10853812|NCT00320528|BG000|Baseline|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853813|NCT00320528|BG001|Baseline|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853814|NCT00320528|BG002|Baseline|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853815|NCT00320528|BG003|Baseline|Total|Total of all reporting groups
10853816|NCT00320528|FG000|Participant Flow|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853817|NCT00320528|FG001|Participant Flow|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853818|NCT00320528|FG002|Participant Flow|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853819|NCT00320528|OG000|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853820|NCT00320528|OG001|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853821|NCT00320528|OG002|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853822|NCT00320528|EG000|Reported Event|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853823|NCT00320528|EG001|Reported Event|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853824|NCT00320528|EG002|Reported Event|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
10853825|NCT00320541|BG000|Baseline|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
10853826|NCT00320541|BG001|Baseline|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
10853827|NCT00320541|BG002|Baseline|Total|Total of all reporting groups
10853828|NCT00320541|FG000|Participant Flow|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
10853829|NCT00320541|FG001|Participant Flow|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
10853830|NCT00320541|OG000|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
10853831|NCT00320541|OG001|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
10853832|NCT00320541|EG000|Reported Event|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
10853833|NCT00320541|EG001|Reported Event|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
10853834|NCT00320593|BG000|Baseline|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
10853835|NCT00320593|BG001|Baseline|Single Vision Lenses (SVLs)|Standard single vision lenses
10853836|NCT00320593|BG002|Baseline|Total|Total of all reporting groups
10853837|NCT00320593|FG000|Participant Flow|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
10853838|NCT00320593|FG001|Participant Flow|Single Vision Lenses (SVLs)|Standard single vision lenses
10853839|NCT00320593|OG000|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
10853840|NCT00320593|OG001|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
10853841|NCT00320593|EG000|Reported Event|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
10853842|NCT00320593|EG001|Reported Event|Single Vision Lenses (SVLs)|Standard single vision lenses
10853843|NCT00320606|BG000|Baseline|Immunosuppression Withdrawal Arm|Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
10853844|NCT00320606|FG000|Participant Flow|Immunosuppression Withdrawal Arm|Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
10853845|NCT00320606|OG000|Outcome|Immunosuppression Withdrawal Arm|Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
10853846|NCT00320606|OG000|Outcome|Immunosuppression Withdrawal Arm|Participants were gradually tapered off of their single immunosuppression drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
10853847|NCT00320606|EG000|Reported Event|Immunosuppression Withdrawal Arm|Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
10853848|NCT00320671|BG000|Baseline|Participants Will Take Aripiprazole|"Participants will take aripiprazole~Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end."
10853849|NCT00320671|BG001|Baseline|Participants Will Take Risperidone|"Participants will take risperidone~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end."
10853850|NCT00320671|BG002|Baseline|Total|Total of all reporting groups
10853851|NCT00320671|FG000|Participant Flow|Participants Will Take Aripiprazole Arm 1|-102 were allocated to Arm 1.
10853852|NCT00320671|FG001|Participant Flow|Participants Will Take Risperidone Arm 2|-96 participants were randomized to to Arm 2
10853853|NCT00320671|OG000|Outcome|Percentage of Participants That Reposonded to Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
10853854|NCT00320671|OG001|Outcome|Percentage of Participants That Reposonded to Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
11221286|NCT02339831|OG001|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
11221287|NCT02339831|EG000|Reported Event|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
11221288|NCT02339831|EG001|Reported Event|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
11221289|NCT02339909|BG000|Baseline|Control|"The intervention for the Control group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Control: Participants receiving the active comparator, (i.e. control) intervention, will be sent the standard diabetic retinopathy screening appointment letter."
11221290|NCT02339909|BG001|Baseline|Fixed Incentive|"The intervention for the fixed incentive group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Fixed financial incentive: Participants receiving the fixed financial incentive intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment."
11221291|NCT02339909|BG002|Baseline|Probabilistic Incentive|"The intervention for the probabilistic incentive group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Probabilistic financial incentive: Participants receiving the probabilistic financial incentive intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment."
11221292|NCT02339909|BG003|Baseline|Total|Total of all reporting groups
11221293|NCT02339909|FG000|Participant Flow|Control|"The intervention for the Control group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Control: Participants receiving the active comparator, (i.e. control) intervention, will be sent the standard diabetic retinopathy screening appointment letter."
11343157|NCT03746002|FG001|Participant Flow|Metolazone Concurrent Dosing|"Metolazone 5 mg by mouth administered at the same time as furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)~Metolazone concurrently with furosemide: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide."
11343158|NCT03746002|OG000|Outcome|Metolazone Concurrent Dosing|"Metolazone 5 mg by mouth administered at the same time as furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)~Metolazone concurrently with furosemide: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide."
11343159|NCT03746002|OG001|Outcome|Metolazone Pre-dosing|"Metolazone 5 mg by mouth administered 60 minutes prior to furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)~Metolazone 60 minutes prior to furosemide: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide."
11343160|NCT03746002|EG000|Reported Event|Metolazone Pre-dosing|"Metolazone 5 mg by mouth administered 60 minutes prior to furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)~Metolazone 60 minutes prior to furosemide: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide."
11343161|NCT03746002|EG001|Reported Event|Metolazone Concurrent Dosing|"Metolazone 5 mg by mouth administered at the same time as furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)~Metolazone concurrently with furosemide: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide."
11343162|NCT03748771|BG000|Baseline|ApneaLink Air Cohort|Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.
11343163|NCT03748771|FG000|Participant Flow|ApneaLink Air Cohort|Patients underwent HST no greater than one week prior to or following their in-lab PSG.
11343164|NCT03748771|OG000|Outcome|ApneaLink Air Cohort|Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.
11343165|NCT03748771|EG000|Reported Event|ApneaLink Air Cohort|Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.
10878854|NCT00454584|EG000|Reported Event|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
10878855|NCT00454584|EG001|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
10878856|NCT00454584|EG002|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
10878857|NCT00454584|EG003|Reported Event|Etanercept (After CP)|After Controlled period (Week 12-64) - receiving etanercept at Weeks 0 -> prior to being treated with ustekinumab
10853855|NCT00320671|EG000|Reported Event|Participants Will Take Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
10853856|NCT00320671|EG001|Reported Event|Participants Will Take Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
10853857|NCT00320710|BG000|Baseline|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
10853858|NCT00320710|BG001|Baseline|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
10853859|NCT00320710|BG002|Baseline|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
10853860|NCT00320710|BG003|Baseline|Total|Total of all reporting groups
10853861|NCT00320710|FG000|Participant Flow|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
11221294|NCT02339909|FG001|Participant Flow|Fixed Incentive|"The intervention for the fixed incentive group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Fixed financial incentive: Participants receiving the fixed financial incentive intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment."
11221295|NCT02339909|FG002|Participant Flow|Probabilistic Incentive|"The intervention for the probabilistic incentive group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Probabilistic financial incentive: Participants receiving the probabilistic financial incentive intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment."
11221296|NCT02339909|OG000|Outcome|Control|"The intervention for the Control group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Control: Participants receiving the active comparator, (i.e. control) intervention, will be sent the standard diabetic retinopathy screening appointment letter."
10853862|NCT00320710|FG001|Participant Flow|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
10853863|NCT00320710|FG002|Participant Flow|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
10853864|NCT00320710|OG000|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
10853865|NCT00320710|OG001|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
10853866|NCT00320710|EG000|Reported Event|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
10853867|NCT00320710|EG001|Reported Event|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
10853868|NCT00320710|EG002|Reported Event|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
10853869|NCT00320749|BG000|Baseline|Capecitabine, Gemcitabine and Docetaxel|Docetaxel i.v. over 30 min on days 1 and 8; Capecitabine p.o. in split doses bid on days 8-21, Gemcitabine i.v. over 75 min on days 8 and 15.
10853870|NCT00320749|FG000|Participant Flow|Dose Level 1|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
10853871|NCT00320749|FG001|Participant Flow|Dose Level 2|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
11221297|NCT02339909|OG001|Outcome|Fixed Incentive|"The intervention for the fixed incentive group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Fixed financial incentive: Participants receiving the fixed financial incentive intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment."
11221298|NCT02339909|OG002|Outcome|Probabilistic Incentive|"The intervention for the probabilistic incentive group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Probabilistic financial incentive: Participants receiving the probabilistic financial incentive intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment."
10853872|NCT00320749|FG002|Participant Flow|Dose Level 3|Docetaxel at 36 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
10878858|NCT00454584|EG004|Reported Event|Etanercept -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) - receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg upon becoming a nonresponder during Week 12 and Week 40. This group is a subpopulation of Etanercept (after CP).
11221299|NCT02339909|EG000|Reported Event|Control|"The intervention for the Control group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Control: Participants receiving the active comparator, (i.e. control) intervention, will be sent the standard diabetic retinopathy screening appointment letter."
11221300|NCT02339909|EG001|Reported Event|Fixed Incentive|"The intervention for the fixed incentive group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Fixed financial incentive: Participants receiving the fixed financial incentive intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment."
11343166|NCT03752177|BG000|Baseline|Cohort A1|Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
11343167|NCT03752177|BG001|Baseline|Cohort A2|Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343168|NCT03752177|BG002|Baseline|Cohort A3|Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343169|NCT03752177|BG003|Baseline|Cohort A4|Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343170|NCT03752177|BG004|Baseline|Total|Total of all reporting groups
11343171|NCT03752177|FG000|Participant Flow|Cohort A1|Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
11343172|NCT03752177|FG001|Participant Flow|Cohort A2|Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343173|NCT03752177|FG002|Participant Flow|Cohort A3|Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343174|NCT03752177|FG003|Participant Flow|Cohort A4|Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343175|NCT03752177|OG000|Outcome|Cohort A1|Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
11343176|NCT03752177|OG001|Outcome|Cohort A2|Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343177|NCT03752177|OG002|Outcome|Cohort A3|Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343178|NCT03752177|OG003|Outcome|Cohort A4|Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343179|NCT03752177|OG000|Outcome|LY3415244 Dose Expansion|Phase 1b dose expansion was planned but not initiated as dose escalation ended at cohort A4. Study did not achieve its primary objective of establishing a recommended phase 2 dose (RP2D) due to early termination of the study by Cohort A4.
11343180|NCT03752177|EG000|Reported Event|Cohort A1|Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
11343181|NCT03752177|EG001|Reported Event|Cohort A2|Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343182|NCT03752177|EG002|Reported Event|Cohort A3|Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343183|NCT03752177|EG003|Reported Event|Cohort A4|Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
11343184|NCT03753763|BG000|Baseline|Safinamide|Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose.
11343185|NCT03753763|BG001|Baseline|Placebo|Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose.
11343186|NCT03753763|BG002|Baseline|Total|Total of all reporting groups
11343187|NCT03753763|FG000|Participant Flow|Safinamide|Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose.
11343188|NCT03753763|FG001|Participant Flow|Placebo|Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose.
11343189|NCT03753763|OG000|Outcome|Safinamide|Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose.
11343190|NCT03753763|OG001|Outcome|Placebo|Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose.
11343191|NCT03753763|EG000|Reported Event|Safinamide|Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose.
10853873|NCT00320749|OG000|Outcome|Capecitabine, Docetaxel, Gemcitabine|"Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.~Capecitabine: Will be give on days 8-21~Docetaxel: Will be given on days 1 and 8,~Gemcitabine: A fixed dose rate will be give on days 8 and 15."
10853874|NCT00320749|OG000|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
10853875|NCT00320749|EG000|Reported Event|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
10853876|NCT00320788|BG000|Baseline|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
10853877|NCT00320788|BG001|Baseline|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
10853878|NCT00320788|BG002|Baseline|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
10853879|NCT00320788|BG003|Baseline|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
10853880|NCT00320788|BG004|Baseline|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
10853881|NCT00320788|BG005|Baseline|Total|Total of all reporting groups
10853882|NCT00320788|FG000|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
10853883|NCT00320788|FG001|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
10853884|NCT00320788|FG002|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
10853885|NCT00320788|FG003|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
10853886|NCT00320788|FG004|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12|Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
10853887|NCT00320788|OG000|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
10853888|NCT00320788|OG001|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
10853889|NCT00320788|OG002|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
10853890|NCT00320788|OG003|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
10853891|NCT00320788|OG004|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
10853892|NCT00320788|OG005|Outcome|Total|
10853893|NCT00320788|OG000|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5mg of aflibercept injection at 4 week intervals through Week 12.
10853894|NCT00320788|OG001|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5mg of aflibercept injection at 12 week intervals through Week 12.
10853895|NCT00320788|OG002|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
10853896|NCT00320788|OG003|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
10853897|NCT00320788|OG004|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
10853898|NCT00320788|EG000|Reported Event|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
10853899|NCT00320788|EG001|Reported Event|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
10853900|NCT00320788|EG002|Reported Event|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
10853901|NCT00320788|EG003|Reported Event|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
10853902|NCT00320788|EG004|Reported Event|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
10853903|NCT00320801|BG000|Baseline|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10853904|NCT00320801|BG001|Baseline|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10853905|NCT00320801|BG002|Baseline|Total|Total of all reporting groups
10853906|NCT00320801|FG000|Participant Flow|Run-in Period|(≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
10853907|NCT00320801|FG001|Participant Flow|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10853908|NCT00320801|FG002|Participant Flow|Double-blind BTDS 20|Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10853909|NCT00320801|FG003|Participant Flow|Extension Phase|Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.
11221301|NCT02339909|EG002|Reported Event|Probabilistic Incentive|"The intervention for the probabilistic incentive group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)~Probabilistic financial incentive: Participants receiving the probabilistic financial incentive intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment."
11221302|NCT02340000|BG000|Baseline|Standard Dose|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days~standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
11221303|NCT02340000|BG001|Baseline|High Dose|"Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days~high dose amoxicillin/clavulanate: Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days"
11221304|NCT02340000|BG002|Baseline|Total|Total of all reporting groups
11221305|NCT02340000|FG000|Participant Flow|Standard Dose|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days~standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
11221306|NCT02340000|FG001|Participant Flow|High Dose|"Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days~high dose amoxicillin/clavulanate: Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days"
11221307|NCT02340000|OG000|Outcome|Standard Dose Time Period I|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days~standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
11221308|NCT02340000|OG001|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
10975790|NCT00937521|OG004|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal multi-component recombinant, adsorbed vaccine (formulation V)and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
11221309|NCT02340000|OG002|Outcome|Standard Dose Time Period 2|Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
11221310|NCT02340000|OG003|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
11221311|NCT02340000|OG000|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
11221312|NCT02340000|OG002|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
11221313|NCT02340000|OG000|Outcome|Overall|First 231 participants
11221314|NCT02340000|EG000|Reported Event|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
11221315|NCT02340000|EG001|Reported Event|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
11221316|NCT02340000|EG002|Reported Event|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
11221317|NCT02340000|EG003|Reported Event|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
11221318|NCT02340078|BG000|Baseline|Demographic Charateristics|Subjects who were included in efficacy evaluation
11221319|NCT02340078|FG000|Participant Flow|Subject Disposition|All Study Participants
11221320|NCT02340078|OG000|Outcome|Subjects With at Least a 10mm Difference in VAS|Subjects with at least a 10mm difference in VAS (HA IDF II - HA IDF II plus)
11221321|NCT02340078|OG001|Outcome|Subjects With Below 10mm Difference in VAS|Subjects with below 10mm difference in VAS (HA IDF II - HA IDF II plus)
11221322|NCT02340078|EG000|Reported Event|Safety|"Subject who were injected with investigational medical device at least once.~The 'Serious Adverse Events' and 'Other Adverse Events' described below occured in each subject regardless of the left or right of the injection site, and since all subjects were injected with both test device and comparator, it was not indicated which side the test device was injected."
11221323|NCT02340091|BG000|Baseline|Demographic Charateristics|Subjects who were included in efficacy evaluation
11221324|NCT02340091|FG000|Participant Flow|Subject Disposition|All Study Participants
11221325|NCT02340091|OG000|Outcome|Subjects With at Least a 10mm Difference in VAS|Subjects with at least a 10mm difference in VAS (HA IDF II - HA IDF II plus)
11221326|NCT02340091|OG001|Outcome|Subjects With Below 10mm Difference in VAS|Subjects with below 10mm difference in VAS (HA IDF II - HA IDF II plus)
11221327|NCT02340091|EG000|Reported Event|Safety|"Subject who were injected with investigational medical device at least once.~The 'Serious Adverse Events' and 'Other Adverse Events' described below occured in each subject regardless of the left or right of the injection site, and since all subjects were injected with both test device and comparator, it was not indicated which side the test device was injected."
11221328|NCT02340104|BG000|Baseline|All Participants|Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
11221329|NCT02340104|FG000|Participant Flow|Baricitinib|Single oral dose of 4 mg baricitinib on Day 1 and approximately the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
11221330|NCT02340104|OG000|Outcome|Baricitinib Oral Dose|Single oral dose of 4 mg baricitinib
11221331|NCT02340104|OG001|Outcome|[^13C4D3^15N]-Baricitinib IV|Single intravenous (IV) infusion of 4 µg[^13C4D3^15N]-baricitinib over 1.5 hours
10975791|NCT00937521|OG005|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
11221332|NCT02340104|EG000|Reported Event|Baricitinib|Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours
11221333|NCT02340156|BG000|Baseline|SGT-53 With Temozolomide|SGT-53, at 3.6 mg DNA/infusion, will be administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) will be administered by mouth daily on days 9-13 of each cycle.
11221334|NCT02340156|FG000|Participant Flow|SGT-53 With Temozolomide|"SGT-53, at 3.6 mg DNA/infusion, will be administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) will be administered by mouth daily on days 9-13 of each cycle.~If SGT-53-related toxicity occurs, the dose of SGT-53 will be de-escalated to 2.4 or 1.2 mg DNA/infusion when appropriate.~Temozolomide: In cycle 1, the dose of TMZ will be 150 mg/m². If the TMZ-related toxicities are tolerated in cycle 1, the dose of TMZ will be escalated to 200 mg/m² for cycle 2 and beyond. If TMZ-related toxicity occurs, the dose if TMZ will be de-escalated to 125 mg/m² (dose level -1), 100 mg/m² (dose level -2) or 75 mg/m² (dose level -3) when appropriate."
11221335|NCT02340156|OG000|Outcome|SGT-53 With Temozolomide|SGT-53, at 3.6 mg DNA/infusion, was administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) was administered by mouth daily on days 9-13 of each cycle.
11221336|NCT02340156|EG000|Reported Event|SGT-53 With Temozolomide|SGT-53, at 3.6 mg DNA/infusion, was administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) was administered by mouth daily on days 9-13 of each cycle.
11221337|NCT02340299|BG000|Baseline|nHFOV|"Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.~The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O.~For infants in the nHFOV-group who fail nHFOV (see definition below), but do not need immediate reintubation, a non-invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.~nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs"
10853910|NCT00320801|OG000|Outcome|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
11221338|NCT02340299|BG001|Baseline|nCPAP|"Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.~The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min.~For infants in the nCPAP-group who fail nCPAP (see definition below), but do not need immediate reintubation, Rescue-nHFOV via binasal prongs may be provided. The decision to attempt Rescue-nHFOV and the ventilator settings used are at the discretion of the attending clinician.~nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs"
10853911|NCT00320801|OG001|Outcome|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
11221339|NCT02340299|BG002|Baseline|Total|Total of all reporting groups
11221340|NCT02340299|FG000|Participant Flow|nHFOV|"Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.~The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O.~For infants in the nHFOV-group who fail nHFOV (see definition below), but do not need immediate reintubation, a non-invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.~nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs"
11221341|NCT02340299|FG001|Participant Flow|nCPAP|"Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.~The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min.~For infants in the nCPAP-group who fail nCPAP (see definition below), but do not need immediate reintubation, Rescue-nHFOV via binasal prongs may be provided. The decision to attempt Rescue-nHFOV and the ventilator settings used are at the discretion of the attending clinician.~nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs"
11221342|NCT02340299|OG000|Outcome|nHFOV|"Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.~The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O.~For infants in the nHFOV-group who fail nHFOV (see definition below), but do not need immediate reintubation, a non-invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.~nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs"
11221343|NCT02340299|OG001|Outcome|nCPAP|"Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.~The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min.~For infants in the nCPAP-group who fail nCPAP (see definition below), but do not need immediate reintubation, Rescue-nHFOV via binasal prongs may be provided. The decision to attempt Rescue-nHFOV and the ventilator settings used are at the discretion of the attending clinician.~nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs"
10853912|NCT00320801|OG002|Outcome|Run-in Period|The run-in period was designed to determine tolerability of BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
10853913|NCT00320801|OG003|Outcome|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
10853914|NCT00320801|EG000|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
10853915|NCT00320801|EG001|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10853916|NCT00320801|EG002|Reported Event|Open-label Run-in Period|The run-in period (14 days) was designed to identify subjects whose pain was controlled with and who tolerated BTDS 20. Open-label BTDS 10 or 20 mcg/h applied for 7-day wear to qualify for randomization into the double-blind phase.
10853917|NCT00320801|EG003|Reported Event|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
11221344|NCT02340299|EG000|Reported Event|nHFOV|"Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.~The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O.~For infants in the nHFOV-group who fail nHFOV (see definition below), but do not need immediate reintubation, a non-invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.~nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs"
11221345|NCT02340299|EG001|Reported Event|nCPAP|"Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.~The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min.~For infants in the nCPAP-group who fail nCPAP (see definition below), but do not need immediate reintubation, Rescue-nHFOV via binasal prongs may be provided. The decision to attempt Rescue-nHFOV and the ventilator settings used are at the discretion of the attending clinician.~nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs"
11221346|NCT02340338|BG000|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221347|NCT02340338|BG001|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221348|NCT02340338|BG002|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221349|NCT02340338|BG003|Baseline|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10853918|NCT00321048|BG000|Baseline|Active Breathing Coordination|"Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.~Patients in this group were treated with Active Breathing Coordinator:~A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion"
10853919|NCT00321048|BG001|Baseline|No Active Breathing Coordination|"Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.~(Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion"
10853920|NCT00321048|BG002|Baseline|Total|Total of all reporting groups
10853921|NCT00321048|FG000|Participant Flow|Active Breathing Coordination|"Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.~Patients in this group were treated with Active Breathing Coordinator:~A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion"
10878859|NCT00454584|EG005|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) - receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
10853922|NCT00321048|FG001|Participant Flow|No Active Breathing Coordination|"Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.~(Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion"
10853923|NCT00321048|OG000|Outcome|Active Breathing Coordination|"Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.~Patients in this group were treated with Active Breathing Coordinator:~A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion"
10853924|NCT00321048|OG001|Outcome|No Active Breathing Coordination|"Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.~(Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion"
10853925|NCT00321048|EG000|Reported Event|Active Breathing Coordination|"Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.~Patients in this group were treated with Active Breathing Coordinator:~A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion"
10853926|NCT00321048|EG001|Reported Event|No Active Breathing Coordination|"Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.~(Patient ARE NOT treated with ABC)~A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion"
10853927|NCT00321269|BG000|Baseline|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
10853928|NCT00321269|BG001|Baseline|8-Week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
10853929|NCT00321269|BG002|Baseline|Total|Total of all reporting groups
10853930|NCT00321269|FG000|Participant Flow|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
10853931|NCT00321269|FG001|Participant Flow|8-week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
10853932|NCT00321269|OG000|Outcome|8-week Phone-based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
10853933|NCT00321269|OG001|Outcome|8-week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
10853934|NCT00321269|OG000|Outcome|8-Week Phone-Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
10853935|NCT00321269|OG001|Outcome|8-Week Phone-Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
10853936|NCT00321269|EG000|Reported Event|8-week Telephone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
10853937|NCT00321269|EG001|Reported Event|8-Week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
10853938|NCT00321321|BG000|Baseline|Sulfonylurea|
10853939|NCT00321321|FG000|Participant Flow|Sulfonylurea|
10853940|NCT00321321|OG000|Outcome|Sulfonylurea|
10853941|NCT00321321|EG000|Reported Event|Sulfonylurea|Sulfonylurea-treated patients
10853942|NCT00321373|BG000|Baseline|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853943|NCT00321373|BG001|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853944|NCT00321373|BG002|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853945|NCT00321373|BG003|Baseline|Total|Total of all reporting groups
10853946|NCT00321373|FG000|Participant Flow|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853947|NCT00321373|FG001|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853948|NCT00321373|FG002|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853949|NCT00321373|OG000|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853950|NCT00321373|OG001|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853951|NCT00321373|OG002|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853952|NCT00321373|EG000|Reported Event|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853953|NCT00321373|EG001|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853954|NCT00321373|EG002|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10853955|NCT00321464|BG000|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
10853956|NCT00321464|BG001|Baseline|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
10853957|NCT00321464|BG002|Baseline|Total|Total of all reporting groups
10853958|NCT00321464|FG000|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
10853959|NCT00321464|FG001|Participant Flow|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
10853960|NCT00321464|OG000|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
10853961|NCT00321464|OG001|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
10853962|NCT00321464|EG000|Reported Event|Zoledronic Acid 4 mg Q4W|
10853963|NCT00321464|EG001|Reported Event|Denosumab 120 mg Q4W|
10853964|NCT00321594|BG000|Baseline|Phase I|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV Level 1: Dose: 600mg/m2/day Level 2: Dose: 900mg/m2/day Level 3: Dose: 1200mg/m2/day"
10853965|NCT00321594|BG001|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV Dose: 1400mg/m2/day"
10853966|NCT00321594|BG002|Baseline|Total|Total of all reporting groups
10853967|NCT00321594|FG000|Participant Flow|Phase I, Level 1|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 600 mg/m2/day"
10853968|NCT00321594|FG001|Participant Flow|Phase I, Level 2|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 900 mg/m2/day"
10853969|NCT00321594|FG002|Participant Flow|Phase I, Level 3|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 1200 mg/m2/day"
10853970|NCT00321594|FG003|Participant Flow|Phase I, Level 4|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 1400 mg/m2/day"
10853971|NCT00321594|FG004|Participant Flow|Phase II, MTD Dose|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 1400 mg/m2/day"
10853972|NCT00321594|OG000|Outcome|Phase I, Level 1|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 600 mg/m2/day"
10853973|NCT00321594|OG001|Outcome|Phase I, Level 2|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 900 mg/m2/day"
10853974|NCT00321594|OG002|Outcome|Phase I, Level 3|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1200mg/m2/day"
10853975|NCT00321594|OG003|Outcome|Phase I, Level 4|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1400mg/m2/day"
10853976|NCT00321594|OG000|Outcome|Phase II, MTD|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1400mg/m2/day"
10853977|NCT00321594|EG000|Reported Event|Phase I, Level 1|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 600 mg/m2/day"
11221350|NCT02340338|BG004|Baseline|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221351|NCT02340338|BG005|Baseline|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221352|NCT02340338|BG006|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221353|NCT02340338|BG007|Baseline|Total|Total of all reporting groups
11221354|NCT02340338|FG000|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221355|NCT02340338|FG001|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221356|NCT02340338|FG002|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221357|NCT02340338|FG003|Participant Flow|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10845348|NCT00266799|BG000|Baseline|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
11336356|NCT03565315|OG004|Outcome|Group 4: 10E8VLS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (*Only 1 Dose)|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11336357|NCT03565315|OG005|Outcome|Overall 10E8VLS Site Only in 10E8VLS+VRC07-523LS Groups|Total number of participants who received an SC injection of 10E8VLS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
10853978|NCT00321594|EG001|Reported Event|Phase 1, Level 2|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 900mg/m2/day"
10853979|NCT00321594|EG002|Reported Event|Phase I, Level 3|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1200mg/m2/day"
10853980|NCT00321594|EG003|Reported Event|Phase I, Level 4|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 600 to 1400mg/m2/day"
10853981|NCT00321594|EG004|Reported Event|Phase II, MTD|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1400mg/m2/day"
10853982|NCT00321620|BG000|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
10853983|NCT00321620|BG001|Baseline|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
10853984|NCT00321620|BG002|Baseline|Total|Total of all reporting groups
10853985|NCT00321620|FG000|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
10853986|NCT00321620|FG001|Participant Flow|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
10853987|NCT00321620|OG000|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
10853988|NCT00321620|OG001|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
10853989|NCT00321620|EG000|Reported Event|Zoledronic Acid 4 mg Q4W|
10853990|NCT00321620|EG001|Reported Event|Denosumab 120 mg Q4W|
10853991|NCT00321646|BG000|Baseline|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
10853992|NCT00321646|FG000|Participant Flow|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
10853993|NCT00321646|OG000|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
10853994|NCT00321646|EG000|Reported Event|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
10853995|NCT00321672|BG000|Baseline|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
10853996|NCT00321672|BG001|Baseline|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10853997|NCT00321672|BG002|Baseline|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
10853998|NCT00321672|BG003|Baseline|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10853999|NCT00321672|BG004|Baseline|Total|Total of all reporting groups
10854000|NCT00321672|FG000|Participant Flow|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
10878860|NCT00454584|EG006|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) - receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
11221358|NCT02340338|FG004|Participant Flow|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221359|NCT02340338|FG005|Participant Flow|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221360|NCT02340338|FG006|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221361|NCT02340338|OG000|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221362|NCT02340338|OG001|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221363|NCT02340338|OG002|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221364|NCT02340338|OG003|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11336358|NCT03565315|OG006|Outcome|Group 3: VRC07-523LS Site Only in 10E8VLS+VRC07-523LS (5 mg/kg) SC Single Dose Group|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11343192|NCT03753763|EG001|Reported Event|Placebo|Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose.
11343193|NCT03756571|BG000|Baseline|Ankle Foot Orthoses-Footwear Combination|"The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.~Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking."
10854001|NCT00321672|FG001|Participant Flow|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10854002|NCT00321672|FG002|Participant Flow|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
10854003|NCT00321672|FG003|Participant Flow|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10854004|NCT00321672|OG000|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
11221365|NCT02340338|OG004|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10854005|NCT00321672|OG001|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10854006|NCT00321672|OG002|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
11221366|NCT02340338|OG005|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221367|NCT02340338|OG006|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221368|NCT02340338|EG000|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221369|NCT02340338|EG001|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11336359|NCT03565315|OG007|Outcome|Group 4: VRC07-523LS Site Only- 10E8VLS+VRC07-523LS (5 mg/kg) SC Multiple Dose Group* (*Only 1 Dose)|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
10878861|NCT00454636|BG000|Baseline|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
10854007|NCT00321672|OG003|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10854008|NCT00321672|OG004|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
10854009|NCT00321672|OG005|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10854010|NCT00321672|EG000|Reported Event|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
10854011|NCT00321672|EG001|Reported Event|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10854012|NCT00321672|EG002|Reported Event|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
10854013|NCT00321672|EG003|Reported Event|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10854014|NCT00321672|EG004|Reported Event|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
10854015|NCT00321672|EG005|Reported Event|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
10854016|NCT00321685|BG000|Baseline|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
10854017|NCT00321685|FG000|Participant Flow|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.~radiation therapy: Patients undergo 3-dimensional conformal radiation therapy once daily 5 days"
10854018|NCT00321685|OG000|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
10878862|NCT00454636|BG001|Baseline|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
10878863|NCT00454636|BG002|Baseline|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
10878864|NCT00454636|BG003|Baseline|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
10878865|NCT00454636|BG004|Baseline|Total|Total of all reporting groups
11221370|NCT02340338|EG002|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11336360|NCT03565315|OG008|Outcome|Overall VRC07-523LS Site Only in 10E8VLS+VRC07-523LS Groups|Total number of participants who received an SC injection of VRC07-523LS in Groups 3 and 4 who received 10E8VLS and VRC07-523LS concurrently
11343194|NCT03756571|BG001|Baseline|Traditional Solid Ankle AFO (TSAFO)|"The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the traditional SAFO (TSAFO)...~Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion."
11343195|NCT03756571|BG002|Baseline|Total|Total of all reporting groups
11343196|NCT03756571|FG000|Participant Flow|Ankle Foot Orthoses-Footwear Combination|"The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.~Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking."
11343197|NCT03756571|FG001|Participant Flow|Traditional Solid Ankle AFO (TSAFO)|"The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the traditional SAFO (TSAFO)...~Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion."
11343198|NCT03756571|OG000|Outcome|Ankle Foot Orthoses-Footwear Combination|"The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.~Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking."
11343199|NCT03756571|OG001|Outcome|Traditional Solid Ankle AFO (TSAFO)|"The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the traditional SAFO (TSAFO)...~Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion."
11343200|NCT03756571|EG000|Reported Event|Ankle Foot Orthoses-Footwear Combination|"The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.~Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking."
11343201|NCT03756571|EG001|Reported Event|Traditional Solid Ankle AFO (TSAFO)|"The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the traditional SAFO (TSAFO)...~Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion."
11343202|NCT03761537|BG000|Baseline|Tralokinumab + TCS|"Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24."
11343203|NCT03761537|BG001|Baseline|Placebo + TCS|"Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24."
11343204|NCT03761537|BG002|Baseline|Total|Total of all reporting groups
11343205|NCT03761537|FG000|Participant Flow|Tralokinumab + TCS|"Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24."
11343206|NCT03761537|FG001|Participant Flow|Placebo + TCS|"Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24."
11343207|NCT03761537|OG000|Outcome|Tralokinumab+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16."
11343208|NCT03761537|OG001|Outcome|Placebo+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16."
11343209|NCT03761537|OG000|Outcome|Tralokinumab|"Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24."
11343210|NCT03761537|OG001|Outcome|Placebo|"Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24."
10878866|NCT00454636|FG000|Participant Flow|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
11221371|NCT02340338|EG003|Reported Event|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221372|NCT02340338|EG004|Reported Event|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221373|NCT02340338|EG005|Reported Event|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221374|NCT02340338|EG006|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
11221375|NCT02340520|BG000|Baseline|Theophylline and Roflumilast|Theophylline for one week, followed by the addition of Roflumilast for a further one week.
11221376|NCT02340520|FG000|Participant Flow|Theophylline and Roflumilast|Theophylline for one week, followed by the addition of Roflumilast for a further one week.
11221377|NCT02340520|OG000|Outcome|Theophylline and Roflumilast|Theophylline for one week, followed by the addition of Roflumilast for a further one week.
11221378|NCT02340520|EG000|Reported Event|Theophylline and Roflumilast|Theophylline for one week, followed by the addition of Roflumilast for a further one week.
11221379|NCT02340663|BG000|Baseline|SOVA Bite Splint|"SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.~SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit."
10878867|NCT00454636|FG001|Participant Flow|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
11221380|NCT02340663|BG001|Baseline|Michigan Bite Splint|"Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.~Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit"
11221381|NCT02340663|BG002|Baseline|Total|Total of all reporting groups
11221382|NCT02340663|FG000|Participant Flow|SOVA Bite Splint|"SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.~SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit."
11221383|NCT02340663|FG001|Participant Flow|Michigan Bite Splint|"Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.~Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit"
11221384|NCT02340663|OG000|Outcome|SOVA Bite Splint|"SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months.~SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit."
11221385|NCT02340663|OG001|Outcome|Michigan Bite Splint|"Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months.~Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit"
11221386|NCT02340663|EG000|Reported Event|SOVA Bite Splint|"SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.~SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit."
11221387|NCT02340663|EG001|Reported Event|Michigan Bite Splint|"Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.~Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit"
11221388|NCT02340715|BG000|Baseline|MRI for Treatment Planning or Follow up|MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care.
11221389|NCT02340715|FG000|Participant Flow|MRI for Treatment Planning or Follow up|MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care.
11221390|NCT02340715|OG000|Outcome|MRI for Treatment Planning or Follow up|Patients aged 18 years and older of any race or gender with brain, head and neck, breast, lung, cervix, sarcoma, pancreatic, or prostate cancer undergoing MRI scans for radiation treatment planning and/or treatment follow-up at FMLH.
11221391|NCT02340715|EG000|Reported Event|MRI for Treatment Planning or Follow up|MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care.
11221392|NCT02340767|BG000|Baseline|No Device Patients Pre-intervention|All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to.
11221393|NCT02340767|BG001|Baseline|Spectra Device Patients Pre-intervention|All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to.
11221394|NCT02340767|BG002|Baseline|DIAGNOdent Device Patients Pre-intervention|All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to.
11343211|NCT03761537|OG000|Outcome|Tralokinumab+TCS|"Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24."
11221395|NCT02340767|BG003|Baseline|No Device Clinicians|They received no device at randomization
11221396|NCT02340767|BG004|Baseline|Spectra Clinicians|The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.
11221397|NCT02340767|BG005|Baseline|DIAGNOdent Clinicians|The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.
11221398|NCT02340767|BG006|Baseline|No Device Patients Post-intervention|
11221399|NCT02340767|BG007|Baseline|Spectra Device Patients Post-intervention|
11221400|NCT02340767|BG008|Baseline|DIAGNOdent Device Patients Post-intervention|
11221401|NCT02340767|BG009|Baseline|Total|Total of all reporting groups
11221402|NCT02340767|FG000|Participant Flow|No Device Practitioners|The practitioners will not receive any additional training.
11221403|NCT02340767|FG001|Participant Flow|Spectra Device Practitioners|"The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.~Spectra Device: Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."
11221404|NCT02340767|FG002|Participant Flow|DIAGNOdent Device Practitioners|"The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.~DIAGNOdent: DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."
11221405|NCT02340767|FG003|Participant Flow|Pre-intervention Patients no Device|The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
11221406|NCT02340767|FG004|Participant Flow|Pre-randomization Patients Spectra|The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
11221407|NCT02340767|FG005|Participant Flow|Pre-randomization Patients DIANGOdent|The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
11221408|NCT02340767|FG006|Participant Flow|Post-randomization Patients no Device|The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
10878868|NCT00454636|FG002|Participant Flow|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
11221409|NCT02340767|FG007|Participant Flow|Post-randomization Patients Spectra|The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
11343212|NCT03761537|OG001|Outcome|Placebo+TCS|"Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24."
11343213|NCT03761537|OG000|Outcome|Tralokinumab+TCS|Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).
11343214|NCT03761537|OG001|Outcome|Placebo+TCS|Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).
11343215|NCT03761537|EG000|Reported Event|Treatment Period: Tralokinumab+TCS|"Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.~For the treatment period, only AEs with a frequency above 2% will be reported. The exception is that AEs reported in the safety follow-up period will also be reported for the treatment period. The total AEs will represent all AEs reported in the treatment period."
11343216|NCT03761537|EG001|Reported Event|Treatment Period: Placebo+TCS|"Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.~For the treatment period, only AEs with a frequency above 2% will be reported. The exception is that AEs reported in the safety follow-up period will also be reported for the treatment period. The total AEs will represent all AEs reported in the treatment period."
11343217|NCT03761537|EG002|Reported Event|Safety Follow-up Period: Tralokinumab+TCS|"Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND).~For the safety follow-up period, all AEs will be reported."
11343218|NCT03761537|EG003|Reported Event|Safety Follow-up Period: Placebo+TCS|"Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND).~For the safety follow-up period, all AEs will be reported."
11343219|NCT03763877|BG000|Baseline|Placebo|Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
11343220|NCT03763877|BG001|Baseline|PXL770 250 mg QD|Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
11343221|NCT03763877|BG002|Baseline|PXL770 250 mg BID|Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
11343222|NCT03763877|BG003|Baseline|PXL770 500 mg QD|Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
11343223|NCT03763877|BG004|Baseline|Total|Total of all reporting groups
11343224|NCT03763877|FG000|Participant Flow|Placebo|"Placebo: Oral capsule~Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks"
11343225|NCT03763877|FG001|Participant Flow|PXL770 250 mg QD|"PXL770 250 mg: Oral capsule Placebo: Oral capsule~Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:~1 capsule of PXL770 250 mg + 1 capsule of placebo in the morning~2 capsules of placebo in the evening"
11343226|NCT03763877|FG002|Participant Flow|PXL770 250 mg BID|"PXL770 250 mg: Oral capsule Placebo: Oral capsule~Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:~1 capsule of PXL770 250 mg + 1 capsule of placebo in the morning~1 capsule of PXL770 250 mg + 1 capsule of placebo in the evening"
11343227|NCT03763877|FG003|Participant Flow|PXL770 500 mg QD|"PXL770 250 mg: Oral capsule Placebo: Oral capsule~Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:~2 capsules of PXL770 250 mg~2 capsules of placebo in the evening"
11343228|NCT03763877|OG000|Outcome|Placebo|Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
11343229|NCT03763877|OG001|Outcome|PXL770 250 mg QD|Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
11343230|NCT03763877|OG002|Outcome|PXL770 250 mg BID|Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
11343231|NCT03763877|OG003|Outcome|PXL770 500 mg QD|Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
11343232|NCT03763877|OG000|Outcome|Placebo|Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
11343233|NCT03763877|OG001|Outcome|PXL770 250 mg QD|Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
10878869|NCT00454636|FG003|Participant Flow|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
10878870|NCT00454636|OG000|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
10854019|NCT00321685|EG000|Reported Event|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
10854020|NCT00321711|BG000|Baseline|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854021|NCT00321711|BG001|Baseline|Romiplostim (AMG 531) 500 mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854022|NCT00321711|BG002|Baseline|Romiplostim (AMG 531) 750 mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854023|NCT00321711|BG003|Baseline|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
10854024|NCT00321711|BG004|Baseline|Romiplostim (AMG 531) 750 mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
10854025|NCT00321711|BG005|Baseline|Total|Total of all reporting groups
10854026|NCT00321711|FG000|Participant Flow|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854027|NCT00321711|FG001|Participant Flow|Romiplostim (AMG 531) 500 mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854028|NCT00321711|FG002|Participant Flow|Romiplostim (AMG 531) 750 mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854029|NCT00321711|FG003|Participant Flow|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
10854030|NCT00321711|FG004|Participant Flow|Romiplostim (AMG 531) 750 mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
10854031|NCT00321711|OG000|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854032|NCT00321711|OG001|Outcome|Romiplostim (AMG 531) 500 mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854033|NCT00321711|OG002|Outcome|Romiplostim (AMG 531) 750 mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
10854034|NCT00321711|OG003|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
10854035|NCT00321711|OG004|Outcome|Romiplostim (AMG 531) 750 mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
10854036|NCT00321711|EG000|Reported Event|Part A Placebo|
10854037|NCT00321711|EG001|Reported Event|Part A Romiplostim 500 µg|
10854038|NCT00321711|EG002|Reported Event|Part A Romiplostim 750 µg|
10854039|NCT00321711|EG003|Reported Event|Part B Placebo|
10854040|NCT00321711|EG004|Reported Event|Part B Romiplostim 750 µg|
10854041|NCT00321737|BG000|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10854042|NCT00321737|BG001|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
10854043|NCT00321737|BG002|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10854044|NCT00321737|BG003|Baseline|Total|Total of all reporting groups
10854045|NCT00321737|FG000|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10854046|NCT00321737|FG001|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
10854047|NCT00321737|FG002|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10854048|NCT00321737|OG000|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10854049|NCT00321737|OG001|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
10854050|NCT00321737|OG002|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10854051|NCT00321737|EG000|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10854052|NCT00321737|EG001|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
10854053|NCT00321737|EG002|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10854054|NCT00321763|BG000|Baseline|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
11343234|NCT03763877|OG002|Outcome|PXL770 250 mg BID|Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
10854055|NCT00321763|BG001|Baseline|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854056|NCT00321763|BG002|Baseline|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854057|NCT00321763|BG003|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
10854058|NCT00321763|BG004|Baseline|Total|Total of all reporting groups
10854059|NCT00321763|FG000|Participant Flow|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854060|NCT00321763|FG001|Participant Flow|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854061|NCT00321763|FG002|Participant Flow|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854062|NCT00321763|FG003|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
10854063|NCT00321763|OG000|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854064|NCT00321763|OG001|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854065|NCT00321763|OG002|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854066|NCT00321763|OG003|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
10854067|NCT00321763|OG004|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
10854068|NCT00321763|EG000|Reported Event|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854069|NCT00321763|EG001|Reported Event|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854070|NCT00321763|EG002|Reported Event|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10854071|NCT00321763|EG003|Reported Event|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
10854072|NCT00321763|EG004|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
10854073|NCT00321789|BG000|Baseline|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
10854074|NCT00321789|BG001|Baseline|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
10854075|NCT00321789|BG002|Baseline|Total|Total of all reporting groups
10854076|NCT00321789|FG000|Participant Flow|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
10854077|NCT00321789|FG001|Participant Flow|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
10854078|NCT00321789|OG000|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
10854079|NCT00321789|OG001|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
10854080|NCT00321789|EG000|Reported Event|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
10854081|NCT00321789|EG001|Reported Event|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
10854082|NCT00321828|BG000|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
10854083|NCT00321828|FG000|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
10854084|NCT00321828|OG000|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
10854085|NCT00321828|EG000|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
10854086|NCT00321854|BG000|Baseline|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
10854087|NCT00321854|BG001|Baseline|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
10854088|NCT00321854|BG002|Baseline|Total|Total of all reporting groups
10854089|NCT00321854|FG000|Participant Flow|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
10854090|NCT00321854|FG001|Participant Flow|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
10854091|NCT00321854|OG000|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
10854092|NCT00321854|OG001|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
10854093|NCT00321854|OG000|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
10854094|NCT00321854|OG001|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
10854095|NCT00321854|EG000|Reported Event|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
10854096|NCT00321854|EG001|Reported Event|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
10854097|NCT00321893|BG000|Baseline|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
10854098|NCT00321893|BG001|Baseline|Arm II: Placebo|Inhaled placebo twice daily for 1 year
10854099|NCT00321893|BG002|Baseline|Total|Total of all reporting groups
10854100|NCT00321893|FG000|Participant Flow|Arm I: Budesonide|Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year
10854101|NCT00321893|FG001|Participant Flow|Arm II: Placebo|Inhaled placebo twice daily for 1 year
10854102|NCT00321893|OG000|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
10854103|NCT00321893|OG001|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
10854104|NCT00321893|EG000|Reported Event|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
10854105|NCT00321893|EG001|Reported Event|Arm II: Placebo|Inhaled placebo twice daily for 1 year
10854106|NCT00321906|BG000|Baseline|Azathioprine|(tacrolimus,azathioprine/prednisone)
10854107|NCT00321906|BG001|Baseline|Sirolimus|tacrolimus/sirolimus/prednisone
10854108|NCT00321906|BG002|Baseline|Total|Total of all reporting groups
10854109|NCT00321906|FG000|Participant Flow|Azathioprine|(tacrolimus,azathioprine/prednisone)
10854110|NCT00321906|FG001|Participant Flow|Sirolimus|tacrolimus/sirolimus/prednisone
10854111|NCT00321906|OG000|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
10854112|NCT00321906|OG001|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
10854113|NCT00321906|EG000|Reported Event|Azathioprine|(tacrolimus,azathioprine/prednisone)
10854114|NCT00321906|EG001|Reported Event|Sirolimus|tacrolimus/sirolimus/prednisone
10854115|NCT00321919|BG000|Baseline|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
10854116|NCT00321919|BG001|Baseline|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
10854117|NCT00321919|BG002|Baseline|Total|Total of all reporting groups
10854118|NCT00321919|FG000|Participant Flow|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hemoglobin (Hb) level of 13-15 gram/decilitre (g/dL) with an individual Hb increase of at least 2 g/dL within approximately 3 months.
10854119|NCT00321919|FG001|Participant Flow|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL has occurred in order to reach a target Hb of 10.5-11.5 g/dL.
10854120|NCT00321919|OG000|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
11221410|NCT02340767|FG008|Participant Flow|Post-randomization Patients DIAGNOdent|The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
11221411|NCT02340767|OG000|Outcome|No Device Patients in Pre-intervention|The patients in pre-intervention are different than post-intervention.
11221412|NCT02340767|OG001|Outcome|No Device Patients Post-intervention|The patients in the pre-intervention stage are not the same as the post-intervention stage.
11221413|NCT02340767|OG002|Outcome|Spectra Patients Post-intervention|The patients in the pre-intervention stage are not the same as the post-intervention stage
11221414|NCT02340767|OG003|Outcome|DIAGNOdent Patients Post-intervention|The patients in the pre-intervention stage are not the same as the post-intervention stage
11221415|NCT02340767|OG000|Outcome|No Device Practitioners|The practitioners will not receive any additional training.
11221416|NCT02340767|OG001|Outcome|Spectra Device Practitioners|"The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.~Spectra Device: Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."
11221417|NCT02340767|OG002|Outcome|DIAGNOdent Device Practitioners|"The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.~DIAGNOdent: DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."
11221418|NCT02340767|EG000|Reported Event|No Device Clinicians|The practitioners will not receive any additional training.
11343235|NCT03763877|OG003|Outcome|PXL770 500 mg QD|Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
11343236|NCT03763877|EG000|Reported Event|Placebo|Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
10845349|NCT00266799|BG001|Baseline|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
10845350|NCT00266799|BG002|Baseline|Total|Total of all reporting groups
11221419|NCT02340767|EG001|Reported Event|Spectra Device Clinicians|"The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.~Spectra Device: Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."
11221420|NCT02340767|EG002|Reported Event|DIAGNOdent Device Clinicians|"The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.~DIAGNOdent: DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."
11221421|NCT02340767|EG003|Reported Event|No Device Patients (Pre-intervention and Post-intervention)|The total number of patients in these two phases is 1000 and 0/1000 were affected. These were 2 different sets of patients.
11221422|NCT02340767|EG004|Reported Event|Spectra Patients (Pre-intervention and Post-intervention)|The total number of patients in these two phases is 918 and 0/918 were affected. These were 2 different sets of patients.
11221423|NCT02340767|EG005|Reported Event|DIAGNOdent Patients (Pre-intervention and Post-intervention)|The total number of patients in these two phases is 1057 and 0/1057 were affected. These were 2 different sets of patients.
11224467|NCT02360293|BG000|Baseline|Stay Strong w/Coaching|"Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.~Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program."
11224468|NCT02360293|BG001|Baseline|Stay Strong|"Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.~Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device."
11224469|NCT02360293|BG002|Baseline|Total|Total of all reporting groups
11224470|NCT02360293|FG000|Participant Flow|Stay Strong w/Coaching|"Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.~Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program."
10854121|NCT00321919|OG001|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
10854122|NCT00321919|OG000|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months
10854123|NCT00321919|EG000|Reported Event|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
10854124|NCT00321919|EG001|Reported Event|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
11221424|NCT02340780|BG000|Baseline|Buparlisib|"100mg daily orally every 28 days~Buparlisib"
11221425|NCT02340780|FG000|Participant Flow|Buparlisib|"100mg daily orally every 28 days~Buparlisib"
11221426|NCT02340780|OG000|Outcome|Buparlisib|"100mg daily orally every 28 days~Buparlisib"
11221427|NCT02340780|EG000|Reported Event|Buparlisib|"100mg daily orally every 28 days~Buparlisib"
11221428|NCT02340806|BG000|Baseline|High Rate Bolus (CADD-Solis Pump)|"Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.~CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period)."
10854125|NCT00321932|BG000|Baseline|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
11221429|NCT02340806|BG001|Baseline|Low Rate Bolus (CADD-Solis Pump)|"Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.~CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period)."
11221430|NCT02340806|BG002|Baseline|Total|Total of all reporting groups
11221431|NCT02340806|FG000|Participant Flow|High Rate Bolus (CADD-Solis Pump)|"Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.~CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period)."
11221432|NCT02340806|FG001|Participant Flow|Low Rate Bolus (CADD-Solis Pump)|"Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.~CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period)."
11221433|NCT02340806|OG000|Outcome|High Rate Bolus (CADD-Solis Pump)|"Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.~CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period)."
11343237|NCT03763877|EG001|Reported Event|PXL770 250 mg QD|Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
10854126|NCT00321932|BG001|Baseline|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
10854127|NCT00321932|BG002|Baseline|Total|Total of all reporting groups
10854128|NCT00321932|FG000|Participant Flow|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
10854129|NCT00321932|FG001|Participant Flow|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
10854130|NCT00321932|OG000|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
10854131|NCT00321932|OG001|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
10854132|NCT00321932|OG001|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV)( over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
10854133|NCT00321932|EG000|Reported Event|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
10854134|NCT00321932|EG001|Reported Event|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
10854135|NCT00321971|BG000|Baseline|Problem Solving Training (PST)|The experimental Intervention focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressors. During the first session, participants received written and verbal education about the family caregiving role, the link between problems, overwhelming stress, symptoms of depression or anxiety, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST. Participants were asked to keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during both phases of the intervention.
10854136|NCT00321971|BG001|Baseline|Nutritional Training (NT)|"The comparison Intervention (Nutritional Training (NT-MCI/AD caregiving) was based on the United States Department of Health and Human Services (USDHHS) 2005 My Pyramid Dietary Guidelines for Americans over Age 50. We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions. Participants were asked to keep a record of menu planning, eating habits between session, and any questions they had related to the application of NT. These records were used as a basis for discussion during both phases of the intervention"
10854137|NCT00321971|BG002|Baseline|Total|Total of all reporting groups
10854138|NCT00321971|FG000|Participant Flow|PST-AD/MCI Caregiving|The experimental Intervention focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressors. During the first session, participants received written and verbal education about the family caregiving role, the link between problems, overwhelming stress, symptoms of depression or anxiety, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST. Participants were asked to keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during both phases of the intervention.
10854139|NCT00321971|FG001|Participant Flow|NT-MCI/AD Caregiving|"The comparison Intervention (Nutritional Training (NT-MCI/AD caregiving) was based on the United States Department of Health and Human Services (USDHHS) 2005 My Pyramid Dietary Guidelines for Americans over Age 50. We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions."
10854140|NCT00321971|OG000|Outcome|Problem Solving Intervention|"The experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It was adapted from the work of Areán and colleagues, who developed a manualized protocol for PST use in primary care. Our adaptation sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressor.~Problem-solving therapy: The self-management intervention will train participants to effectively use problem-solving skills with the aim of strengthening their ability to cope and preventing the onset or worsening of depressive and anxiety disorders. All participants attend weekly individual training sessions, either in their home, another convenient location, or by telephone for a total of 9 weeks."
10854141|NCT00321971|OG001|Outcome|Nutritional Intervention|"The comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) was based on the United States Department of Health and Human Services (USDHHS) 2005 My Pyramid Dietary Guidelines for Americans over Age 50. We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions.~Nutritional education program: The nutritional education program will be based on the new USDA dietary recommendations. All participants attend weekly individual training sessions, either in their home or another convenient location for a total of 6 weeks."
10854142|NCT00321971|EG000|Reported Event|Experimental Intervention|"The experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.~During the first session, participants received written and verbal education about the structure of sessions, MCI or dementia and the family caregiving role, the link between problems, overwhelming stress, and symptoms of depression, the relationship between low mood and reduced pleasurable activities, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST."
10854143|NCT00321971|EG001|Reported Event|Comparison/Control Intervention|"The comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) was based on the USDHHS My Pyramid Dietary Guidelines for Americans over Age 50. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions.~During the first session, participants received written and verbal education about the structure of the sessions, MCI or dementia, and an overview of USDA Dietary Guidelines. Participants also completed a questionnaire about their current eating practices and activity level. In subsequent training sessions, the interventionist provided education related to the major food categories, discretionary calories, and tips and resources for menu planning. Participants were asked to keep a record of menu planning, eating habits between session, and any questions they had related to the application of NT. These records were used as a basis for discussion during both phases of the intervention."
10854144|NCT00321984|BG000|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
11343238|NCT03763877|EG002|Reported Event|PXL770 250 mg BID|Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
11343239|NCT03763877|EG003|Reported Event|PXL770 500 mg QD|Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
11343240|NCT03764007|BG000|Baseline|18F-Fluorocholine PET|"Patients will undergo a single fluorocholine PET imaging study prior to surgery.~18F-Fluorocholine: Given intravenously~Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities"
11343241|NCT03764007|FG000|Participant Flow|18F-Fluorocholine PET|"Patients will undergo a single fluorocholine PET imaging study prior to surgery.~18F-Fluorocholine: Given intravenously~Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities"
11343242|NCT03764007|OG000|Outcome|18F-Fluorocholine PET|"Patients will undergo a single fluorocholine PET imaging study prior to surgery.~18F-Fluorocholine: Given intravenously~Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities"
11343243|NCT03764007|EG000|Reported Event|18F-Fluorocholine PET|"Patients will undergo a single fluorocholine PET imaging study prior to surgery.~18F-Fluorocholine: Given intravenously~Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities"
11343244|NCT03772587|BG000|Baseline|Placebo|Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.
11343245|NCT03772587|BG001|Baseline|Nipocalimab 5 Milligrams/Kilogram (mg/kg)|Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343246|NCT03772587|BG002|Baseline|Nipocalimab 30 mg/kg|Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343247|NCT03772587|BG003|Baseline|Nipocalimab 60 mg/kg|Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.
11343248|NCT03772587|BG004|Baseline|Nipocalimab 60 mg/kg (Q2W)|Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
11343249|NCT03772587|BG005|Baseline|Total|Total of all reporting groups
11343250|NCT03772587|FG000|Participant Flow|Placebo|Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.
11343251|NCT03772587|FG001|Participant Flow|Nipocalimab (M281) 5 Milligrams/Kilogram (mg/kg)|Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343252|NCT03772587|FG002|Participant Flow|Nipocalimab 30 mg/kg|Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343253|NCT03772587|FG003|Participant Flow|Nipocalimab 60 mg/kg|Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.
11343254|NCT03772587|FG004|Participant Flow|Nipocalimab 60 mg/kg (Q2W)|Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
11343255|NCT03772587|OG000|Outcome|Placebo|Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.
11343256|NCT03772587|OG001|Outcome|Nipocalimab 5 Milligrams/Kilogram (mg/kg)|Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343257|NCT03772587|OG002|Outcome|Nipocalimab 30 mg/kg|Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343258|NCT03772587|OG003|Outcome|Nipocalimab 60 mg/kg|Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.
11343259|NCT03772587|OG004|Outcome|Nipocalimab 60 mg/kg (Q2W)|Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
11343260|NCT03772587|OG000|Outcome|Placebo|Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
11343261|NCT03772587|OG001|Outcome|Nipocalimab 5 mg/kg|Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343262|NCT03772587|OG000|Outcome|Placebo/Nipocalimab (All Participants)|All participants combined over all arms received IV infusion either of placebo or nipocalimab (5 mg/kg [once Q4W]/30 mg/kg[once Q4W]/60 mg/kg[once Q4W]/60 mg/kg [once Q2W]) starting Day 1 up to Day 57.
11343263|NCT03772587|OG000|Outcome|Placebo/Nipocalimab (All Anti-AChR Positive Participants)|All anti-AChR positive participants combined over all arms received IV infusion of either placebo or nipocalimab (5 mg/kg [once Q4W]/30 mg/kg[once Q4W]/60 mg/kg[once Q4W]/60 mg/kg [once Q2W]) starting Day 1 up to Day 57.
11343264|NCT03772587|OG000|Outcome|Placebo/Nipocalimab (All Participants)|All participants combined over all arms received IV infusion of either placebo or nipocalimab (5 mg/kg [once Q4W]/30 mg/kg[once Q4W]/60 mg/kg[once Q4W]/60 mg/kg [once Q2W]) starting Day 1 up to Day 57.
11343265|NCT03772587|OG001|Outcome|Nipocalimab 5 Milligram/Kilogram (mg/kg)|Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343266|NCT03772587|OG000|Outcome|Nipocalimab 5 mg/kg|Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343267|NCT03772587|OG001|Outcome|Nipocalimab 30 mg/kg|Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343268|NCT03772587|OG002|Outcome|Nipocalimab 60 mg/kg|Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.
11343269|NCT03772587|OG003|Outcome|Nipocalimab 60 mg/kg (Q2W)|Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
11343270|NCT03772587|EG000|Reported Event|Placebo|Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.
11343271|NCT03772587|EG001|Reported Event|Nipocalimab 5 Milligrams/Kilogram (mg/kg)|Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343272|NCT03772587|EG002|Reported Event|Nipocalimab 30 mg/kg|Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
11343273|NCT03772587|EG003|Reported Event|Nipocalimab 60 mg/kg|Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.
11343274|NCT03772587|EG004|Reported Event|Nipocalimab 60 mg/kg (Q2W)|Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
11343275|NCT03789292|BG000|Baseline|CT-P17|Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
11343276|NCT03789292|BG001|Baseline|EU-approved Humira|Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
11343277|NCT03789292|BG002|Baseline|Total|Total of all reporting groups
11343278|NCT03789292|FG000|Participant Flow|CT-P17 Subcutaneous(SC) (Adalimumab)|"Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.~Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48."
11343279|NCT03789292|FG001|Participant Flow|EU-approved Humira SC (Adalimumab)|"Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.~Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48."
11343280|NCT03789292|FG002|Participant Flow|Switched to CT-P17|"Treatment Period 1: N/A~Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48."
11343281|NCT03789292|OG000|Outcome|CT-P17 Subcutaneous(SC) (Adalimumab)|"Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.~Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48."
11343282|NCT03789292|OG001|Outcome|EU-approved Humira SC (Adalimumab)|"Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.~Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48."
11343283|NCT03789292|OG000|Outcome|CT-P17|Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
11343284|NCT03789292|OG001|Outcome|EU-approved Humira|Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
11343285|NCT03789292|OG000|Outcome|CT-P17 Maintenance|All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
11343286|NCT03789292|OG001|Outcome|Humira Maintenance|Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
11343287|NCT03789292|OG002|Outcome|Switched to CT-P17|Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
11343288|NCT03789292|EG000|Reported Event|Treatment 1: CT-P17|Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
11343289|NCT03789292|EG001|Reported Event|Treatment 1: EU-approved Humira|Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
11343290|NCT03789292|EG002|Reported Event|Treatment 2: CT-P17 Maintenance|All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
11343291|NCT03789292|EG003|Reported Event|Treatment 2: Humira Maintenance|Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
10854145|NCT00321984|BG001|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
11343292|NCT03789292|EG004|Reported Event|Treatment 2: Switched to CT-P17|Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
11343293|NCT03799289|BG000|Baseline|Iyengar Yoga|"Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.~Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention"
11343294|NCT03799289|BG001|Baseline|Cooking/Dietary Education|"Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.~Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention"
11343295|NCT03799289|BG002|Baseline|Total|Total of all reporting groups
11343296|NCT03799289|FG000|Participant Flow|Iyengar Yoga|"Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.~Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention"
11343297|NCT03799289|FG001|Participant Flow|Cooking/Dietary Education|"Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.~Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention"
11343298|NCT03799289|OG000|Outcome|Iyengar Yoga|"Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.~Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention"
11343299|NCT03799289|OG001|Outcome|Cooking/Dietary Education|"Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.~Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention"
11343300|NCT03799289|EG000|Reported Event|Iyengar Yoga|"Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.~Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention"
11343301|NCT03799289|EG001|Reported Event|Cooking/Dietary Education|"Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.~Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention"
11343302|NCT03801408|BG000|Baseline|Arkansas First Responders|All participants were current or retired first responders in Arkansas, including certified Emergency Responders, Emergency Medical Technicians, Paramedics, and Firefighters.
11343303|NCT03801408|FG000|Participant Flow|Arkansas First Responders|All participants were current or retired first responders in Arkansas, including certified Emergency Responders, Emergency Medical Technicians, Paramedics, and Firefighters.
11343304|NCT03801408|OG000|Outcome|Arkansas First Responders|All participants were current or retired first responders in Arkansas, including certified Emergency Responders, Emergency Medical Technicians, Paramedics, and Firefighters.
11343305|NCT03801408|EG000|Reported Event|Arkansas First Responders|All participants were current or retired first responders in Arkansas, including certified Emergency Responders, Emergency Medical Technicians, Paramedics, and Firefighters.
11343306|NCT03805438|BG000|Baseline|Chloroprocaine Dose|"Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).~Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml."
11343307|NCT03805438|FG000|Participant Flow|Chloroprocaine Dose|"Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).~Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml."
11343308|NCT03805438|OG000|Outcome|Chloroprocaine Dose|"Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).~Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml."
11343309|NCT03805438|EG000|Reported Event|Chloroprocaine Dose|"Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).~Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.~At the completion of this study, there were no adverse events experienced by any patients enrolled in the study. As such, the delineation of adverse events on a per dose level is unnecessary."
11343310|NCT03808948|BG000|Baseline|All Patients|"VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous~VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11343311|NCT03808948|FG000|Participant Flow|All Patients|"VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous~VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11343312|NCT03808948|OG000|Outcome|All Patients|"VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous~VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11343313|NCT03808948|EG000|Reported Event|All Patients|"VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous~VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11343314|NCT03810053|BG000|Baseline|Mobile App/Online Module|"Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.~Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures."
11343315|NCT03810053|FG000|Participant Flow|Mobile App/Online Module|"Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.~Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures."
11343316|NCT03810053|OG000|Outcome|Mobile App/Online Module|"Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.~Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures."
11343317|NCT03810053|EG000|Reported Event|Mobile App/Online Module|"Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.~Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures."
11343318|NCT03817528|BG000|Baseline|ITI-007|"Open-Label ITI-007 40-60 mg~ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events"
11343319|NCT03817528|FG000|Participant Flow|ITI-007|"Open-Label ITI-007 40-60 mg~ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events"
11343320|NCT03817528|OG000|Outcome|ITI-007|"Open-Label ITI-007 40-60 mg~ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events"
11343321|NCT03817528|EG000|Reported Event|ITI-007|"Open-Label ITI-007 40-60 mg~ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events"
10854146|NCT00321984|BG002|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
11343322|NCT03817580|BG000|Baseline|Project X 26ml|"3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use.~Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343323|NCT03817580|BG001|Baseline|Project X 5.1ml|"3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use.~Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343324|NCT03817580|BG002|Baseline|Prevantics Maxi Swabstick|"3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use.~Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343325|NCT03817580|BG003|Baseline|Total|Total of all reporting groups
11343326|NCT03817580|FG000|Participant Flow|Project X 26ml|"3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use.~Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
10854147|NCT00321984|BG003|Baseline|Total|Total of all reporting groups
11221434|NCT02340806|OG001|Outcome|Low Rate Bolus (CADD-Solis Pump)|"Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.~CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period)."
11221435|NCT02340806|EG000|Reported Event|High Rate Bolus (CADD-Solis Pump)|"Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.~CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period)."
11221436|NCT02340806|EG001|Reported Event|Low Rate Bolus (CADD-Solis Pump)|"Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.~CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period)."
11221437|NCT02340819|BG000|Baseline|Teduglutide|Optimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued.
11221438|NCT02340819|FG000|Participant Flow|Teduglutide|Optimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued.
11343327|NCT03817580|FG001|Participant Flow|Project X 5.1ml|"3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use.~Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343328|NCT03817580|FG002|Participant Flow|Prevantics Maxi Swabstick|"3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use.~Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343329|NCT03817580|OG000|Outcome|Project X 26ml|"3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.~Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343330|NCT03817580|OG001|Outcome|Project X 5.1ml|"3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.~Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343331|NCT03817580|OG002|Outcome|Prevantics Maxi Swabstick|"3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.~Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343332|NCT03817580|EG000|Reported Event|Project X 26ml|"3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use.~Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343333|NCT03817580|EG001|Reported Event|Project X 5.1ml|"3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use.~Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343334|NCT03817580|EG002|Reported Event|Prevantics Maxi Swabstick|"3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use.~Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343335|NCT03828422|BG000|Baseline|Patients With Essential Thrombocythemia|"essential thrombocythemia with JAK2 V617F positive mutation~patients from the Department of Haematology at University Medical Centre Ljubljana, Slovenia, who were diagnosed with JAK2 V617F positive ET between 2011 and 2014~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~examined twice, the first time in the years 2014-2015 and for the second time in the years 2018-2019~blood for laboratory tests~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning~imaging"
11221439|NCT02340819|OG000|Outcome|Teduglutide|Optimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued.
11221440|NCT02340819|EG000|Reported Event|Teduglutide|Optimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued.
11343336|NCT03828422|BG001|Baseline|Control Group|"the control group is selected among healthy employees of the University Medical Centre Ljubljana and their relatives~they are matched with the patient group for age and sex distribution and classical risk factors for cardiovascular disease~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~blood for laboratory tests~examined twice, the first time in the years 2014-2015 and for the second time the in years 2018-2019~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning~imaging"
11221441|NCT02340949|BG000|Baseline|mFOLFOX6 + Aflibercept|"- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~- Aflibercept, will be administered intravenously (I.V.) at doses of 4 mg/Kg on Day 1 every 14 days. Aflibercept will be supplied to sites by the study Sponsor as 4 ml vials at a concentration of 25 mg/ml.~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~Aflibercept: Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU"
11221442|NCT02340949|BG001|Baseline|mFOLFOX6|"- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU"
11221443|NCT02340949|BG002|Baseline|Total|Total of all reporting groups
11221444|NCT02340949|FG000|Participant Flow|mFOLFOX6 + Aflibercept|"- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~- Aflibercept, will be administered intravenously (I.V.) at doses of 4 mg/Kg on Day 1 every 14 days. Aflibercept will be supplied to sites by the study Sponsor as 4 ml vials at a concentration of 25 mg/ml.~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~Aflibercept: Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU"
11221445|NCT02340949|FG001|Participant Flow|mFOLFOX6|"- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU"
11224471|NCT02360293|FG001|Participant Flow|Stay Strong|"Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.~Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device."
11343337|NCT03828422|BG002|Baseline|Total|Total of all reporting groups
11343338|NCT03828422|FG000|Participant Flow|Patients With Essential Thrombocythemia|"essential thrombocythemia with JAK2 V617F positive mutation~patients from the Department of Haematology at University Medical Centre Ljubljana, Slovenia, who were diagnosed with JAK2 V617F positive ET between 2011 and 2014~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~examined twice, the first time in the years 2014-2015 and for the second time in the years 2018-2019~blood for laboratory tests~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning~imaging"
10845351|NCT00266799|FG000|Participant Flow|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
11343339|NCT03828422|FG001|Participant Flow|Control Group|"the control group is selected among healthy employees of the University Medical Centre Ljubljana and their relatives~they are matched with the patient group for age and sex distribution and classical risk factors for cardiovascular disease~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~blood for laboratory tests~examined twice, the first time in the years 2014-2015 and for the second time the in years 2018-2019~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning~imaging"
11343340|NCT03828422|OG000|Outcome|Patients With Essential Thrombocythemia|"essential thrombocythemia with JAK2 V617F positive mutation~patients from the Department of Haematology at University Medical Centre Ljubljana, Slovenia, who were diagnosed with JAK2 V617F positive ET between 2011 and 2014~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~examined twice, the first time in the years 2014-2015 and for the second time in the years 2018-2019~blood for laboratory tests~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning~imaging"
11343341|NCT03828422|OG001|Outcome|Control Group|"the control group is selected among healthy employees of the University Medical Centre Ljubljana and their relatives~they are matched with the patient group for age and sex distribution and classical risk factors for cardiovascular disease~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~blood for laboratory tests~examined twice, the first time in the years 2014-2015 and for the second time the in years 2018-2019~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning~imaging"
11343342|NCT03828422|OG000|Outcome|Patients With Essential Thrombocythemia|"essential thrombocythemia with JAK2 V617F positive mutation~patients from the Department of Haematology at University Medical Centre Ljubljana, Slovenia, who were diagnosed with JAK2 V617F positive ET between 2011 and 2014~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~examined twice, the first time in the years 2014-2015 and for the second time in the years 2018-2019~blood for laboratory tests~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning"
11221446|NCT02340949|OG000|Outcome|mFOLFOX6 + Aflibercept|"- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~- Aflibercept, will be administered intravenously (I.V.) at doses of 4 mg/Kg on Day 1 every 14 days. Aflibercept will be supplied to sites by the study Sponsor as 4 ml vials at a concentration of 25 mg/ml.~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~Aflibercept: Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU"
11221447|NCT02340949|OG001|Outcome|mFOLFOX6|"- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU"
11221448|NCT02340949|EG000|Reported Event|mFOLFOX6 + Aflibercept|"- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~- Aflibercept, will be administered intravenously (I.V.) at doses of 4 mg/Kg on Day 1 every 14 days. Aflibercept will be supplied to sites by the study Sponsor as 4 ml vials at a concentration of 25 mg/ml.~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~Aflibercept: Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU"
11221449|NCT02340949|EG001|Reported Event|mFOLFOX6|"- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU"
10845352|NCT00266799|FG001|Participant Flow|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
11221450|NCT02340962|BG000|Baseline|Group I|200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
11343343|NCT03828422|EG000|Reported Event|Patients With Essential Thrombocythemia|"essential thrombocythemia with JAK2 V617F positive mutation~patients from the Department of Haematology at University Medical Centre Ljubljana, Slovenia, who were diagnosed with JAK2 V617F positive ET between 2011 and 2014~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~examined twice, the first time in the years 2014-2015 and for the second time in the years 2018-2019~blood for laboratory tests~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning~imaging"
11221451|NCT02340962|BG001|Baseline|Group II|400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
11221452|NCT02340962|BG002|Baseline|Total|Total of all reporting groups
11221453|NCT02340962|FG000|Participant Flow|Group I|200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
11221454|NCT02340962|FG001|Participant Flow|Group II|400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
11221455|NCT02340962|OG000|Outcome|Group I|200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
11221456|NCT02340962|OG001|Outcome|Group II|400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
11221457|NCT02340962|EG000|Reported Event|Group I|200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
11221458|NCT02340962|EG001|Reported Event|Group II|400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
11221459|NCT02340975|BG000|Baseline|Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)|Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221460|NCT02340975|BG001|Baseline|Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221461|NCT02340975|BG002|Baseline|Phase 2 Arm B-M10 mg/kg (Q2W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
11221462|NCT02340975|BG003|Baseline|Phase 2 Arm C-T10 mg/kg (Q4W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
11221463|NCT02340975|BG004|Baseline|Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221464|NCT02340975|BG005|Baseline|Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221465|NCT02340975|BG006|Baseline|Total|Total of all reporting groups
11221466|NCT02340975|FG000|Participant Flow|Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)|Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221467|NCT02340975|FG001|Participant Flow|Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221468|NCT02340975|FG002|Participant Flow|Phase 2 Arm B-M10 mg/kg (Q2W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
11221469|NCT02340975|FG003|Participant Flow|Phase 2 Arm C-T10 mg/kg (Q4W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
10854148|NCT00321984|FG000|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
11221470|NCT02340975|FG004|Participant Flow|Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221471|NCT02340975|FG005|Participant Flow|Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221472|NCT02340975|OG000|Outcome|Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)|Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221473|NCT02340975|OG000|Outcome|Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221474|NCT02340975|OG001|Outcome|Phase 2 Arm B-M10 mg/kg (Q2W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
11221475|NCT02340975|OG002|Outcome|Phase 2 Arm C-T10 mg/kg (Q4W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
11221476|NCT02340975|OG003|Outcome|Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221477|NCT02340975|OG004|Outcome|Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221478|NCT02340975|OG000|Outcome|Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221479|NCT02340975|EG000|Reported Event|Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)|Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221480|NCT02340975|EG001|Reported Event|Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11343344|NCT03828422|EG001|Reported Event|Control Group|"the control group is selected among healthy employees of the University Medical Centre Ljubljana and their relatives~they are matched with the patient group for age and sex distribution and classical risk factors for cardiovascular disease~no personal history of clinically manifest atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)~all signed the informed consent~blood for laboratory tests~examined twice, the first time in the years 2014-2015 and for the second time the in years 2018-2019~imaging and functional examination: ultrasound examination, EndoPat plethysmography, coronary artery calcium scanning~imaging"
11221481|NCT02340975|EG002|Reported Event|Phase 2 Arm B-M10 mg/kg (Q2W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
11221482|NCT02340975|EG003|Reported Event|Phase 2 Arm C-T10 mg/kg (Q4W)|Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
11221483|NCT02340975|EG004|Reported Event|Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11221484|NCT02340975|EG005|Reported Event|Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)|Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
11343345|NCT03829228|BG000|Baseline|All Participants|"Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks.~Proglucamune: Following screening and enrollment, participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Each Proglucamune tablet contained ~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes)."
11343346|NCT03829228|FG000|Participant Flow|All Participants Received Proglucamune Treatment.|Following screening and enrollment, participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Each Proglucamune tablet contained ~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes).
11343347|NCT03829228|OG000|Outcome|All Participants|"Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks.~Proglucamune: Following screening and enrollment, participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Each Proglucamune tablet contained ~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes)."
11343348|NCT03829228|EG000|Reported Event|All Participants|"Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks.~Proglucamune: Following screening and enrollment, participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Each Proglucamune tablet contained ~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes)."
11343349|NCT03829618|BG000|Baseline|Topical Lidocaine|"16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.~Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots"
11343350|NCT03829618|BG001|Baseline|Nebuliser Solution|"2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.~Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer"
11343351|NCT03829618|BG002|Baseline|Atomizer Solution|"2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.~Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer"
11343352|NCT03829618|BG003|Baseline|Total|Total of all reporting groups
11343353|NCT03829618|FG000|Participant Flow|Topical Lidocaine|"16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.~Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots"
11343354|NCT03829618|FG001|Participant Flow|Nebuliser Solution|"2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.~Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer"
11343355|NCT03829618|FG002|Participant Flow|Atomizer Solution|"2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.~Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer"
11343356|NCT03829618|OG000|Outcome|Topical Lidocaine|"16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.~Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots"
11343357|NCT03829618|OG001|Outcome|Nebuliser Solution|"2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.~Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer"
11343358|NCT03829618|OG002|Outcome|Atomizer Solution|"2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.~Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer"
11343359|NCT03829618|EG000|Reported Event|Topical Lidocaine|"16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.~Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots"
11343360|NCT03829618|EG001|Reported Event|Nebuliser Solution|"2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.~Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer"
11343361|NCT03829618|EG002|Reported Event|Nebuliser Suspension|"2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.~Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer"
10845353|NCT00266799|OG000|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
11343362|NCT03830333|BG000|Baseline|Ceftolozane/Tazobactam + Metronidazole|Participants received ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam could be adjusted to 500 mg/250 mg if CrCL was 30 to ≤50 mL/min).
11343363|NCT03830333|BG001|Baseline|Meropenem + Placebo|Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min).
11343364|NCT03830333|BG002|Baseline|Total|Total of all reporting groups
11343365|NCT03830333|FG000|Participant Flow|Ceftolozane/Tazobactam + Metronidazole|Participants received ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam could be adjusted to 500 mg/250 mg if CrCL was 30 to ≤50 mL/min).
11343366|NCT03830333|FG001|Participant Flow|Meropenem + Placebo|Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min).
11343367|NCT03830333|OG000|Outcome|Ceftolozane/Tazobactam + Metronidazole|Participants received ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam could be adjusted to 500 mg/250 mg if CrCL was 30 to ≤50 mL/min).
11221485|NCT02341144|BG000|Baseline|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
11343368|NCT03830333|OG001|Outcome|Meropenem + Placebo|Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min).
11343369|NCT03830333|EG000|Reported Event|Ceftolozane/Tazobactam + Metronidazole|Participants received ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam could be adjusted to 500 mg/250 mg if CrCL was 30 to ≤50 mL/min).
11343370|NCT03830333|EG001|Reported Event|Meropenem + Placebo|Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min).
11343371|NCT03831880|BG000|Baseline|Daily Genotropin Then Weekly Somatrogon|Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
11343372|NCT03831880|BG001|Baseline|Weekly Somatrogon Then Daily Genotropin|Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.
11343373|NCT03831880|BG002|Baseline|Total|Total of all reporting groups
11343374|NCT03831880|FG000|Participant Flow|Daily Genotropin Then Weekly Somatrogon|Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
11343375|NCT03831880|FG001|Participant Flow|Weekly Somatrogon Then Daily Genotropin|Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.
11343376|NCT03831880|OG000|Outcome|Daily Genotropin Then Weekly Somatrogon|Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
11343377|NCT03831880|OG001|Outcome|Weekly Somatrogon Then Daily Genotropin|Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.
11343378|NCT03831880|OG000|Outcome|Genotropin|Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
11343379|NCT03831880|OG001|Outcome|Somatrogon|Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).
11343380|NCT03831880|EG000|Reported Event|Genotropin|Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
11343381|NCT03831880|EG001|Reported Event|Somatrogon|Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).
11343382|NCT03831945|BG000|Baseline|Single Infusion of VRC01 and 10-1074|Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is >/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
11343383|NCT03831945|BG001|Baseline|Single Infusion of Normal Saline|Single infusion of 100 mL and 250 mL of normal saline when viral load is >/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
11343384|NCT03831945|BG002|Baseline|Total|Total of all reporting groups
11343385|NCT03831945|FG000|Participant Flow|Single Infusion of VRC01 and 10-1074|Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is >/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
11343386|NCT03831945|FG001|Participant Flow|Single Infusion of Normal Saline|Single infusion of 100 mL and 250 mL of normal saline when viral load is >/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
11343387|NCT03831945|OG000|Outcome|Single Infusion of VRC01 and 10-1074|Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is >/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
11343388|NCT03831945|OG001|Outcome|Single Infusion of Normal Saline|Single infusion of 100 mL and 250 mL of normal saline when viral load is >/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
11221486|NCT02341144|BG001|Baseline|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
11343389|NCT03831945|EG000|Reported Event|Single Infusion of VRC01 and 10-1074|Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is >/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
11343390|NCT03831945|EG001|Reported Event|Single Infusion of Normal Saline|Single infusion of 100 mL and 250 mL of normal saline when viral load is >/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
11343391|NCT03835728|BG000|Baseline|Treatment Arm|"Ocrelizumab will be administered 3 times over a 1 year study period. Subjects will receive a dose of 300 mg at week 0 (baseline) and again at week 2. The final dose of 600 mg will be administered at week 24.~Ocrelizumab: Subjects will be randomized in a 1:1 fashion to receive infusion of Ocrelizumab (2 doses at 300 mg and 1 dose at 600 mg) or matched placebo. The 2 300 mg doses will be administered at day 2 and day 14. The 600 mg dose will be administered during the 6 month visit. The drug will be administered via infusion three times throughout the trial period: after the initial screening, at two weeks from initial infusion, and at 6 months."
11221487|NCT02341144|BG002|Baseline|Total|Total of all reporting groups
11221488|NCT02341144|FG000|Participant Flow|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
11221489|NCT02341144|FG001|Participant Flow|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
11221490|NCT02341144|OG000|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
11221491|NCT02341144|OG001|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
11343392|NCT03835728|BG001|Baseline|Treatment Placebo Arm|"Saline will be used as the matching placebo~Saline: This will be the matching placebo used in the study."
11343393|NCT03835728|BG002|Baseline|Total|Total of all reporting groups
11221492|NCT02341144|EG000|Reported Event|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
11221493|NCT02341144|EG001|Reported Event|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
11221494|NCT02341417|BG000|Baseline|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11221495|NCT02341417|BG001|Baseline|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
10854149|NCT00321984|FG001|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
10854150|NCT00321984|FG002|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
11343394|NCT03835728|FG000|Participant Flow|Treatment Arm|"Ocrelizumab will be administered 3 times over a 1 year study period. Subjects will receive a dose of 300 mg at week 0 (baseline) and again at week 2. The final dose of 600 mg will be administered at week 24.~Ocrelizumab: Subjects will be randomized in a 1:1 fashion to receive infusion of Ocrelizumab (2 doses at 300 mg and 1 dose at 600 mg) or matched placebo. The 2 300 mg doses will be administered at day 2 and day 14. The 600 mg dose will be administered during the 6 month visit. The drug will be administered via infusion three times throughout the trial period: after the initial screening, at two weeks from initial infusion, and at 6 months."
11343395|NCT03835728|FG001|Participant Flow|Treatment Placebo Arm|"Saline will be used as the matching placebo~Saline: This will be the matching placebo used in the study."
11343396|NCT03835728|OG000|Outcome|Treatment Arm|"Ocrelizumab will be administered 3 times over a 1 year study period. Subjects will receive a dose of 300 mg at week 0 (baseline) and again at week 2. The final dose of 600 mg will be administered at week 24.~Ocrelizumab: Subjects will be randomized in a 1:1 fashion to receive infusion of Ocrelizumab (2 doses at 300 mg and 1 dose at 600 mg) or matched placebo. The 2 300 mg doses will be administered at day 2 and day 14. The 600 mg dose will be administered during the 6 month visit. The drug will be administered via infusion three times throughout the trial period: after the initial screening, at two weeks from initial infusion, and at 6 months."
11343397|NCT03835728|OG001|Outcome|Treatment Placebo Arm|"Saline will be used as the matching placebo~Saline: This will be the matching placebo used in the study."
11343398|NCT03835728|EG000|Reported Event|Treatment Arm|"Ocrelizumab will be administered 3 times over a 1 year study period. Subjects will receive a dose of 300 mg at week 0 (baseline) and again at week 2. The final dose of 600 mg will be administered at week 24.~Ocrelizumab: Subjects will be randomized in a 1:1 fashion to receive infusion of Ocrelizumab (2 doses at 300 mg and 1 dose at 600 mg) or matched placebo. The 2 300 mg doses will be administered at day 2 and day 14. The 600 mg dose will be administered during the 6 month visit. The drug will be administered via infusion three times throughout the trial period: after the initial screening, at two weeks from initial infusion, and at 6 months."
11343399|NCT03835728|EG001|Reported Event|Treatment Placebo Arm|"Saline will be used as the matching placebo~Saline: This will be the matching placebo used in the study."
11343400|NCT03840174|BG000|Baseline|V160: CMV Seropositive at Baseline|Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.
11343401|NCT03840174|BG001|Baseline|Placebo: CMV Seropositive at Baseline|Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
11343402|NCT03840174|BG002|Baseline|V160: CMV Seronegative at Baseline|Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.
11343403|NCT03840174|BG003|Baseline|Placebo: CMV Seronegative at Baseline|Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
11343404|NCT03840174|BG004|Baseline|Total|Total of all reporting groups
11343405|NCT03840174|FG000|Participant Flow|V160: CMV Seronegative at Baseline|Participants who were cytomegalovirus (CMV)-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.
11343406|NCT03840174|FG001|Participant Flow|V160: CMV Seropositive at Baseline|Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.
11343407|NCT03840174|FG002|Participant Flow|Placebo: CMV Seronegative at Baseline|Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
11343408|NCT03840174|FG003|Participant Flow|Placebo: CMV Seropositive at Baseline|Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
11343409|NCT03840174|OG000|Outcome|V160: CMV Seronegative at Baseline|Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.
11343410|NCT03840174|OG001|Outcome|V160: CMV Seropositive at Baseline|Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.
11343411|NCT03840174|OG002|Outcome|Placebo: CMV Seronegative at Baseline|Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
11343412|NCT03840174|OG003|Outcome|Placebo: CMV Seropositive at Baseline|Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
11343413|NCT03840174|OG001|Outcome|Placebo: CMV Seronegative at Baseline|Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
11343414|NCT03840174|EG000|Reported Event|V160: CMV Seronegative at Baseline|Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.
11343415|NCT03840174|EG001|Reported Event|V160: CMV Seropositive at Baseline|Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.
11343416|NCT03840174|EG002|Reported Event|Placebo: CMV Seronegative at Baseline|Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
11343417|NCT03840174|EG003|Reported Event|Placebo: CMV Seropositive at Baseline|Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
10854151|NCT00321984|OG000|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
11343418|NCT03848910|BG000|Baseline|Investigational Device - Sound Processor|"Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to pre-study experience using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator."
11343419|NCT03848910|FG000|Participant Flow|Investigational Device - Sound Processor|"Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to pre-study experience using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator."
11343420|NCT03848910|OG000|Outcome|Investigational Device - Sound Processor|"Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to pre-study experience using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator."
11343421|NCT03848910|OG000|Outcome|Investigational Device - Sound Processor|"Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to pre-study experience using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator."
11343422|NCT03848910|EG000|Reported Event|Investigational Device - Sound Processor|"Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to pre-study experience using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator."
11343423|NCT03852524|BG000|Baseline|Study Arm: Methylnaltrexone|"The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).~Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery."
11343424|NCT03852524|BG001|Baseline|Placebo Arm|"The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).~Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery."
11343425|NCT03852524|BG002|Baseline|Total|Total of all reporting groups
11343426|NCT03852524|FG000|Participant Flow|Study Arm: Methylnaltrexone|"The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).~Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery."
11343427|NCT03852524|FG001|Participant Flow|Placebo Arm|"The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).~Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery."
11343428|NCT03852524|OG000|Outcome|Study Arm: Methylnaltrexone|"The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).~Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery."
11343429|NCT03852524|OG001|Outcome|Placebo Arm|"The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).~Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery."
11343430|NCT03852524|EG000|Reported Event|Study Arm: Methylnaltrexone|"The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).~Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery."
10854152|NCT00321984|OG001|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
10854153|NCT00321984|OG002|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10854154|NCT00321984|EG000|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10854155|NCT00321984|EG001|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
11343431|NCT03852524|EG001|Reported Event|Placebo Arm|"The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).~Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery."
11343432|NCT03857841|BG000|Baseline|20 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 20 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343433|NCT03857841|BG001|Baseline|60 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 60 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343434|NCT03857841|BG002|Baseline|200 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 200 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343435|NCT03857841|BG003|Baseline|Placebo|"Phosphate-buffered saline~Phosphate-buffered saline: Phosphate-buffered saline"
11343436|NCT03857841|BG004|Baseline|Total|Total of all reporting groups
11343437|NCT03857841|FG000|Participant Flow|20 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 20 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343438|NCT03857841|FG001|Participant Flow|60 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 60 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343439|NCT03857841|FG002|Participant Flow|200 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 200 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343440|NCT03857841|FG003|Participant Flow|Placebo|"Phosphate-buffered saline~Phosphate-buffered saline: Phosphate-buffered saline"
11343441|NCT03857841|OG000|Outcome|20 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 20 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343442|NCT03857841|OG001|Outcome|60 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 60 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343443|NCT03857841|OG002|Outcome|200 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 200 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343444|NCT03857841|OG003|Outcome|Placebo|"Phosphate-buffered saline~Phosphate-buffered saline: Phosphate-buffered saline"
11343445|NCT03857841|EG000|Reported Event|20 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 20 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343446|NCT03857841|EG001|Reported Event|60 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 60 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343447|NCT03857841|EG002|Reported Event|200 Pmol Phospholipid/kg Body Weight|"UNEX-42 administered at 200 pmol phospholipid/kg body weight~UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline."
11343448|NCT03857841|EG003|Reported Event|Placebo|"Phosphate-buffered saline~Phosphate-buffered saline: Phosphate-buffered saline"
11343449|NCT03861780|BG000|Baseline|Project X 26ml|"3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use.~Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343450|NCT03861780|BG001|Baseline|Project X 5.1ml|"3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 5.1ml volume. Single use.~Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343451|NCT03861780|BG002|Baseline|Prevantics Maxi Swabstick|"3.15% w/v CHG / 70% v/v IPA. Swabstick. Single use.~Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343452|NCT03861780|BG003|Baseline|Total|Total of all reporting groups
11343453|NCT03861780|FG000|Participant Flow|Project X 26ml|"3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use.~Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
10975792|NCT00937521|EG000|Reported Event|B+OMV (Group I)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
11343454|NCT03861780|FG001|Participant Flow|Project X 5.1ml|"3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 5.1ml volume. Single use.~Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343455|NCT03861780|FG002|Participant Flow|Prevantics Maxi Swabstick|"3.15% w/v CHG / 70% v/v IPA. Swabstick. Single use.~Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343456|NCT03861780|OG000|Outcome|Project X 26ml|"3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.~Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343457|NCT03861780|OG001|Outcome|Project X 5.1ml|"3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use.~Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11221496|NCT02341417|BG002|Baseline|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11221497|NCT02341417|BG003|Baseline|Total|Total of all reporting groups
11221498|NCT02341417|FG000|Participant Flow|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11221499|NCT02341417|FG001|Participant Flow|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11221500|NCT02341417|FG002|Participant Flow|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11221501|NCT02341417|OG000|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11221502|NCT02341417|OG001|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11336361|NCT03565315|OG003|Outcome|Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11343458|NCT03861780|OG002|Outcome|Prevantics Maxi Swabstick|"3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use.~Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343459|NCT03861780|EG000|Reported Event|Project X 26 mL|"3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.~Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343460|NCT03861780|EG001|Reported Event|Project X 5.1 mL|"3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1 ml volume. Single use.~Project X 5.1 ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects"
11343461|NCT03861780|EG002|Reported Event|Prevantics Maxi Swabstick|"3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) Swabstick. Single use.~Application of antiseptic drug to inguinal and abdomen areas of the subjects"
11343462|NCT03862625|BG000|Baseline|a Modular Adaptive Seating System|"In the first group, there is home exercises program for scoliosis and a modular adaptive seating system.~a modular adaptive seating system~home exercise program for scoliosis"
11343463|NCT03862625|BG001|Baseline|Home Exercises for Scoliosis|"In the second group there is only home exercise program for scoliosis.~home exercise program for scoliosis"
11343464|NCT03862625|BG002|Baseline|Total|Total of all reporting groups
11343465|NCT03862625|FG000|Participant Flow|a Modular Adaptive Seating System|"In the first group, there is home exercises program for scoliosis and a modular adaptive seating system.~a modular adaptive seating system~home exercise program for scoliosis"
11343466|NCT03862625|FG001|Participant Flow|Home Exercises for Scoliosis|"In the second group there is only home exercise program for scoliosis.~home exercise program for scoliosis"
11343467|NCT03862625|OG000|Outcome|a Modular Adaptive Seating System|"In the first group, there is home exercises program for scoliosis and a modular adaptive seating system.~a modular adaptive seating system~home exercise program for scoliosis"
11343468|NCT03862625|OG001|Outcome|Home Exercises for Scoliosis|"In the second group there is only home exercise program for scoliosis.~home exercise program for scoliosis"
11343469|NCT03862625|EG000|Reported Event|a Modular Adaptive Seating System|"In the first group, there is home exercises program for scoliosis and a modular adaptive seating system.~a modular adaptive seating system~home exercise program for scoliosis"
11343470|NCT03862625|EG001|Reported Event|Home Exercises for Scoliosis|"In the second group there is only home exercise program for scoliosis.~home exercise program for scoliosis"
10845354|NCT00266799|OG001|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
11343471|NCT03862755|BG000|Baseline|Thromboprophylaxis|"All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk.~Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9)."
11343472|NCT03862755|FG000|Participant Flow|Thromboprophylaxis|"All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk.~Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9)."
11343473|NCT03862755|OG000|Outcome|Thromboprophylaxis|"All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk.~Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9)."
11343474|NCT03862755|EG000|Reported Event|Thromboprophylaxis|"All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk.~Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9)."
11348485|NCT04173741|FG001|Participant Flow|Leg Rise Position - 1 Minute|"Patients who stayed in passive leg rise position for 1 minute~Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done."
11348486|NCT04173741|OG000|Outcome|Leg Rise Position - 3 Minutes|"Patients who stayed in passive leg rise position for 3 minutes~Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. Internal jugular vein (IJV) visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done."
11348487|NCT04173741|OG001|Outcome|Leg Rise Position - 1 Minute|"Patients who stayed in passive leg rise position for 1 minute~Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. Internal jugular vein (IJV) visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done."
11221503|NCT02341417|OG002|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11343475|NCT03869541|BG000|Baseline|Intensive Care Patients|"Adult intensive care patients receiving vasoactive drugs~Mobilization: Physical rehabilitation"
11343476|NCT03869541|BG001|Baseline|Intensive Care Clinicians|Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
11343477|NCT03869541|BG002|Baseline|Intensive Care Rehabilitation Clinicians|Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool.
11343478|NCT03869541|BG003|Baseline|Total|Total of all reporting groups
11343479|NCT03869541|FG000|Participant Flow|Intensive Care Patients|"Adult intensive care patients receiving vasoactive drugs~Mobilization: Physical rehabilitation"
11343480|NCT03869541|FG001|Participant Flow|Intensive Care Unit Clinicians|Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
11343481|NCT03869541|FG002|Participant Flow|ICU Rehabilitation Clinicians|Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool.
11343482|NCT03869541|OG000|Outcome|Intensive Care Patients|"Adult intensive care patients receiving vasoactive drugs~Mobilization: Physical rehabilitation"
11343483|NCT03869541|OG000|Outcome|Intensive Care Patients/Consultee|Adult intensive care patients or the consultees of patients enrolled in the study.
11343484|NCT03869541|OG001|Outcome|Intensive Care Doctors|Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
11343485|NCT03869541|OG002|Outcome|Intensive Care Nurses|Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
11343486|NCT03869541|OG003|Outcome|Intensive Care Physiotherapists|Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
10845355|NCT00266799|EG000|Reported Event|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
10845356|NCT00266799|EG001|Reported Event|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
11343487|NCT03869541|OG000|Outcome|ICU Rehabilitation Clinicians|Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool.
11343488|NCT03869541|EG000|Reported Event|Intensive Care Patients|"Adult intensive care patients receiving vasoactive drugs~Mobilization: Physical rehabilitation"
11343489|NCT03869541|EG001|Reported Event|Intensive Care Unit Clinicians|Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
10854156|NCT00321984|EG002|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10854157|NCT00322023|BG000|Baseline|D-serine 30 mg/kg|
10854158|NCT00322023|BG001|Baseline|D-serine 60 mg/kg|
10854159|NCT00322023|BG002|Baseline|D Serine 120 mg/kg|
10854160|NCT00322023|BG003|Baseline|Total|Total of all reporting groups
10854161|NCT00322023|FG000|Participant Flow|D-serine 30 mg/kg|Open label, adjunctive to antipsychotics for 4 weeks
11343490|NCT03869541|EG002|Reported Event|ICU Rehabilitation Clinicians|Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool.
11343491|NCT03877224|BG000|Baseline|Dapa 10 mg|Dapagliflozin 10 mg, given once daily per oral use.
11343492|NCT03877224|BG001|Baseline|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11343493|NCT03877224|BG002|Baseline|Total|Total of all reporting groups
11343494|NCT03877224|FG000|Participant Flow|Dapa 10 mg|Dapagliflozin 10 mg, given once daily per oral use.
11343495|NCT03877224|FG001|Participant Flow|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11343496|NCT03877224|OG000|Outcome|Dapa 10mg|Dapagliflozin 10 mg, given once daily per oral use.
11343497|NCT03877224|OG001|Outcome|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11343498|NCT03877224|EG000|Reported Event|Dapa 10 mg|Dapagliflozin 10 mg, given once daily per oral use.
11343499|NCT03877224|EG001|Reported Event|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11343500|NCT03883607|BG000|Baseline|Elafibranor 80 mg|Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
11343501|NCT03883607|BG001|Baseline|Elafibranor 120 mg|Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
11343502|NCT03883607|BG002|Baseline|Total|Total of all reporting groups
11343503|NCT03883607|FG000|Participant Flow|Elafibranor 80 mg|Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
11343504|NCT03883607|FG001|Participant Flow|Elafibranor 120 mg|Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
11343505|NCT03883607|OG000|Outcome|Elafibranor 80 mg|Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
11343506|NCT03883607|OG001|Outcome|Elafibranor 120 mg|Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
11343507|NCT03883607|EG000|Reported Event|Elafibranor 80 mg|Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
11343508|NCT03883607|EG001|Reported Event|Elafibranor 120 mg|Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
11343509|NCT03885596|BG000|Baseline|CA-008 (Vocacapsaicin) Cohort 1|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine HCl: 1.5% 12 mL at the end of surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative"
11343510|NCT03885596|BG001|Baseline|CA-008 (Vocacapsaicin) Cohort 2|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343511|NCT03885596|BG002|Baseline|CA-008 (Vocacapsaicin) Cohort 3|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343512|NCT03885596|BG003|Baseline|Exparel|"106 mg [8 mL of the 133 mg/10 mL suspension] only~All subjects received monitored anesthesia care (MAC) and a Mayo block.~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery~Exparel: Bupivacaine liposome injection suspension"
11343513|NCT03885596|BG004|Baseline|Total|Total of all reporting groups
11343514|NCT03885596|FG000|Participant Flow|CA-008 Cohort 1|"CA-008 4.2 mg~All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.~CA-008: Drug: CA-008 4.2 mg~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine HCl: 1.5% 12 mL at the end of surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative"
11343515|NCT03885596|FG001|Participant Flow|CA-008 Cohort 2|"CA-008 4.2 mg~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343516|NCT03885596|FG002|Participant Flow|CA-008 Cohort 3|"CA-008 4.2 mg~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343517|NCT03885596|FG003|Participant Flow|Exparel|"106 mg [8 mL of the 133 mg/10 mL suspension] only~All subjects received monitored anesthesia care (MAC) and a Mayo block.~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery~Exparel: Bupivacaine liposome injection suspension"
11343518|NCT03885596|OG000|Outcome|CA-008 Cohort 1|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine HCl: 1.5% 12 mL at the end of surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative"
11343519|NCT03885596|OG001|Outcome|CA-008 Cohort 2|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343520|NCT03885596|OG002|Outcome|CA-008 Cohort 3|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343521|NCT03885596|OG003|Outcome|Exparel|"106 mg [8 mL of the 133 mg/10 mL suspension] only~All subjects received monitored anesthesia care (MAC) and a Mayo block.~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery~Exparel: Bupivacaine liposome injection suspension"
11221504|NCT02341417|EG000|Reported Event|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
10975793|NCT00937521|EG001|Reported Event|B+½ OMV (Group II)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
11221505|NCT02341417|EG001|Reported Event|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11221506|NCT02341417|EG002|Reported Event|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
11221507|NCT02341417|EG003|Reported Event|Total|All participants who received cinacalcet in study 20140159.
11221508|NCT02341456|BG000|Baseline|Cohort 1|Subjects in Cohort 1 received a single oral dose of 175 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 175 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous paclitaxel (175 mg/m²) and intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221509|NCT02341456|BG001|Baseline|Cohort 1a|Subjects in Cohort 1a received a single oral dose of 175 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 175 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221510|NCT02341456|BG002|Baseline|Cohort 2|Subjects in Cohort 2 received a single oral dose of 225 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 225 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous paclitaxel (175 mg/m²) and intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221511|NCT02341456|BG003|Baseline|Total|Total of all reporting groups
11221512|NCT02341456|FG000|Participant Flow|Cohort 1|Subjects in Cohort 1 received a single oral dose of 175 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 175 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous paclitaxel (175 mg/m²) and intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221513|NCT02341456|FG001|Participant Flow|Cohort 1a|Subjects in Cohort 1a received a single oral dose of 175 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 175 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221514|NCT02341456|FG002|Participant Flow|Cohort 2|Subjects in Cohort 2 received a single oral dose of 225 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 225 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous paclitaxel (175 mg/m²) and intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221515|NCT02341456|OG000|Outcome|Cohort 1|Subjects in Cohort 1 received a single oral dose of 175 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 175 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous paclitaxel (175 mg/m²) and intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221516|NCT02341456|OG001|Outcome|Cohort 1a|Subjects in Cohort 1a received a single oral dose of 175 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 175 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221517|NCT02341456|OG002|Outcome|Cohort 2|Subjects in Cohort 2 received a single oral dose of 225 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 225 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous paclitaxel (175 mg/m²) and intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221518|NCT02341456|EG000|Reported Event|Cohort 1|Subjects in Cohort 1 received a single oral dose of 175 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 175 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous paclitaxel (175 mg/m²) and intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221519|NCT02341456|EG001|Reported Event|Cohort 1a|Subjects in Cohort 1a received a single oral dose of 175 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 175 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
11221520|NCT02341456|EG002|Reported Event|Cohort 2|Subjects in Cohort 2 received a single oral dose of 225 mg of AZD1775 monotherapy followed 5 ± 2 days later by combination therapy consisting of 5 oral doses of 225 mg AZD1775 given 12 hours apart on days 1, 2, and 3 and single doses of intravenous paclitaxel (175 mg/m²) and intravenous carboplatin (AUC 5) given on day 1 of 21 day cycles.
10845357|NCT00266812|BG000|Baseline|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
10975794|NCT00937521|EG002|Reported Event|B+1/4 OMV (Group III)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
11343522|NCT03885596|OG000|Outcome|CA-008 (Vocacapsaicin) Cohort 1|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine HCl: 1.5% 12 mL at the end of surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative"
11343523|NCT03885596|OG001|Outcome|CA-008 (Vocacapsaicin) Cohort 2|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343524|NCT03885596|OG002|Outcome|CA-008 (Vocacapsaicin) Cohort 3|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343525|NCT03885596|EG000|Reported Event|CA-008 Cohort 1|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine HCl: 1.5% 12 mL at the end of surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative"
11343526|NCT03885596|EG001|Reported Event|CA-008 Cohort 2|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Celecoxib: 200 mg PO bid each day postoperative~Acetaminophen Oral: 1 g postoperative~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343527|NCT03885596|EG002|Reported Event|CA-008 Cohort 3|"CA-008 4.2 mg reconstituted in saline~All subjects received monitored anesthesia care (MAC) and a Mayo block.~CA-008: Drug: CA-008 4.2 mg reconstituted in saline~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery"
11343528|NCT03885596|EG003|Reported Event|Exparel|"106 mg [8 mL of the 133 mg/10 mL suspension] only~All subjects received monitored anesthesia care (MAC) and a Mayo block.~Ketorolac: 30 mg IV at the onset of anesthesia~Acetaminophen IV: 1 g at the onset of anesthesia~Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery~Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery~Lidocaine Hydrochloride: 2% 15 mL at the end of surgery~Exparel: Bupivacaine liposome injection suspension"
11343529|NCT03885661|BG000|Baseline|Icosapent Ethyl|"Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background~Icosapent Ethyl 1000 MG [Vascepa]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate."
11343530|NCT03885661|BG001|Baseline|Usual Care|Statin background
10854162|NCT00322023|FG001|Participant Flow|D-serine 60 mg/kg|Open label, adjunctive to antipsychotics for 4 weeks
11221521|NCT02341482|BG000|Baseline|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
11343531|NCT03885661|BG002|Baseline|Total|Total of all reporting groups
11343532|NCT03885661|FG000|Participant Flow|Icosapent Ethyl|"Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background~Icosapent Ethyl 1000 MG [Vascepa]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate."
11343533|NCT03885661|FG001|Participant Flow|Usual Care|Statin background
11343534|NCT03885661|OG000|Outcome|Icosapent Ethyl|"Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background~Icosapent Ethyl 1000 MG [Vascepa]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate."
11343535|NCT03885661|OG001|Outcome|Usual Care|Statin background
11343536|NCT03885661|EG000|Reported Event|Icosapent Ethyl|"Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background~Icosapent Ethyl 1000 MG [Vascepa]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate."
11343537|NCT03885661|EG001|Reported Event|Usual Care|Statin background
11343538|NCT03886493|BG000|Baseline|Dupixent Subcutaneous (SQ) Injection|"Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.~Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43."
11343539|NCT03886493|FG000|Participant Flow|Dupixent Subcutaneous (SQ) Injection|"Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.~Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43."
11343540|NCT03886493|OG000|Outcome|Dupixent Subcutaneous (SQ) Injection|"Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.~Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43."
11343541|NCT03886493|EG000|Reported Event|Dupixent Subcutaneous (SQ) Injection|"Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.~Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43."
11343542|NCT03888235|BG000|Baseline|Immediate Corrective Exercises|"After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:~Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh.~In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh.~For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium.~Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later.~At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that."
11221522|NCT02341482|FG000|Participant Flow|All Subjects|PF-04958242 0.10 milligram (mg) loading dose was administered orally twice daily (BID) on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), once daily (QD).
11221523|NCT02341482|OG000|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
11221524|NCT02341482|OG001|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
11221525|NCT02341482|OG000|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
11221526|NCT02341482|OG002|Outcome|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
11221527|NCT02341482|EG000|Reported Event|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
11343543|NCT03888235|BG001|Baseline|Immediate Use of Pelvic Support Belt|"Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later.~At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later."
11221528|NCT02341482|EG001|Reported Event|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
11221529|NCT02341482|EG002|Reported Event|PF-04958242 0.025 mg Combined With Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg combined with itraconazole 200 mg orally.
11221530|NCT02341599|BG000|Baseline|Group A: Healthy|Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion.
11221531|NCT02341599|BG001|Baseline|Group B: Mild RI|Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion.
11221532|NCT02341599|BG002|Baseline|Group C: Moderate RI|Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion.
11221533|NCT02341599|BG003|Baseline|Group D: Severe RI|Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion.
11221534|NCT02341599|BG004|Baseline|Group E: ESRD-HD|Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD [doses given 48 hours apart]).
11221535|NCT02341599|BG005|Baseline|Total|Total of all reporting groups
11221536|NCT02341599|FG000|Participant Flow|Group A: Healthy|Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion.
11221537|NCT02341599|FG001|Participant Flow|Group B: Mild RI|Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion.
11343544|NCT03888235|BG002|Baseline|Delayed Treatment|"These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be assessed then given both the exercise and the pelvic stabilization belt to use for one month.~The concurrent use of both treatments will be assessed at their last visit two months after their initial visit."
11343545|NCT03888235|BG003|Baseline|Total|Total of all reporting groups
11343546|NCT03888235|FG000|Participant Flow|Immediate Corrective Exercises|"After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:~Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh.~In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh.~For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium.~Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later.~At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that."
11343547|NCT03888235|FG001|Participant Flow|Immediate Use of Pelvic Support Belt|"Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later.~At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later."
11343548|NCT03888235|FG002|Participant Flow|Delayed Treatment|"These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt.~The concurrent use of both treatments will be assessed at their last visit one month after that.~Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention."
11343549|NCT03888235|OG000|Outcome|Immediate Corrective Exercises (SIFFTE)|"After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises (SIFFTE) to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:~Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh.~In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh.~For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium.~Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later.~At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that."
11343550|NCT03888235|OG001|Outcome|Immediate Use of Pelvic Support Belt|"Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later.~At that time they will be given the exercises to correct their sacroiliac malrotation (SIFFTE) and the concurrent use of both treatments will be assessed at their last visit one month later."
11343551|NCT03888235|OG002|Outcome|Delayed Treatment|"These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the corrective exercise (SIFFTE) and the pelvic support belt.~The concurrent use of both treatments, the corrective exercise (SIFFTE) and the pelvic support belt will be assessed at their last visit one month after that."
11343552|NCT03888235|OG000|Outcome|Baseline Oswestry Disability Index (ODI) Score|All participants received the Oswestry Disability Index ODI questionnaire on being admitted in the study. The ODI score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored X5). Minimum = 0, maximum = 100. Higher scores mean a worse outcome.
11348488|NCT04173741|EG000|Reported Event|Leg Rise Position - 3 Minutes|"Patients who stayed in passive leg rise position for 3 minutes~Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done."
11221538|NCT02341599|FG002|Participant Flow|Group C: Moderate RI|Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion.
11343553|NCT03888235|OG001|Outcome|ODI After Immediate Corrective Exercises + Sacroiliac Stabilization Belt Used For One Month|All participants get the sacroiliac forward flexion test (SIFFT): standing, trunk forward flexed the posterior superior iliac spine (PSIS) levels are found and measured. A higher painful PSIS has anterior, a lower one has posterior malrotation. They are given the appropriate exercise to correct their sacroiliac malrotation. Anterior rotation is corrected with the flexed thigh pushing hard on the anterior superior iliac spine to force it posteriorly. Posterior rotation is corrected by hyperextending the thigh, using the sartorius and the rectus femoris to pull the ilium anteriorly. 3 techniques: - genuflection, anterior side foot and posterior side knee on the floor, hands on either side of the foot, knee stretched backwards, - anterior side foot on chair, pull up on chair to force the thigh against the ilium, - in dorsal decubitus assistant with anterior side foot on their sternum leans forward to push the thigh against ilium and pushes down on extended posterior side thigh to overstretch it. All these are held for 2 minutes. They are then fitted with a sacroiliac stabilization belt to wear as needed for back pain producing activities. They are reassessed using the Oswestry disability Index score (ODI) one month later at their two month visit.
11343554|NCT03888235|OG000|Outcome|Immediate Corrective Exercises|"After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:~Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh.~In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh.~For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium.~Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later.~At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that."
11221539|NCT02341599|FG003|Participant Flow|Group D: Severe RI|Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion.
11221540|NCT02341599|FG004|Participant Flow|Group E: ESRD-HD|Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD [doses given 48 hours apart]).
11221541|NCT02341599|OG000|Outcome|Group A: Healthy|Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion.
11221542|NCT02341599|OG001|Outcome|Group B: Mild RI|Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion.
11221543|NCT02341599|OG002|Outcome|Group C: Moderate RI|Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion.
11221544|NCT02341599|OG003|Outcome|Group D: Severe RI|Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion.
11221545|NCT02341599|OG004|Outcome|Group E: ESRD-HD Period 1|Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
11221546|NCT02341599|OG005|Outcome|Group E: ESRD-HD Period 2|Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
11221547|NCT02341599|OG004|Outcome|Group E: ESRD-HD Periods 1 and 2|Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as 2 1-hour infusions (1 before HD and 1 after HD).
11221548|NCT02341599|OG000|Outcome|Group E: ESRD-HD Period 1|Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
11221549|NCT02341599|EG000|Reported Event|Group A: Healthy|Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion.
11221550|NCT02341599|EG001|Reported Event|Group B: Mild RI|Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion.
11221551|NCT02341599|EG002|Reported Event|Group C: Moderate RI|Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion.
11221552|NCT02341599|EG003|Reported Event|Group D: Severe RI|Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion.
11221553|NCT02341599|EG004|Reported Event|Group E: ESRD-HD|Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD [doses given 48 hours apart]).
11221554|NCT02341859|BG000|Baseline|Overall Participant Flow|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
11221555|NCT02341859|FG000|Participant Flow|Stenfilcon A/Delefilcon A, Then Stenfilcon A/Narafilcon A|"Participants randomized wear the stenfilcon A and delefilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and narafilcon A lens pair contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
11343555|NCT03888235|OG001|Outcome|Immediate Use of Pelvic Support Belt|"Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later.~At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later."
11221556|NCT02341859|FG001|Participant Flow|Stenfilcon A/Narafilcon A, Then Stenfilcon A/Delefilcon A|"Participants randomized wear the stenfilcon A and narafilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and delefilcon A lens pair contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens~delefilcon A: contact lens"
11221557|NCT02341859|OG000|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
11221558|NCT02341859|OG001|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
11221559|NCT02341859|OG002|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
11221560|NCT02341859|OG003|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
11221561|NCT02341859|OG001|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
11221562|NCT02341859|OG002|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
11221563|NCT02341859|OG000|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
11221564|NCT02341859|OG003|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
11343556|NCT03888235|OG002|Outcome|Delayed Treatment|"These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt.~The concurrent use of both treatments will be assessed at their last visit one month after that.~Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention."
11343557|NCT03888235|OG000|Outcome|Initial Brief Pain Inventory (BPI) Pain Score|"At their initial visit, all participants fill out the brief pain inventory (BPI) pain score: on a scale of 0 (no pain) to 10 (worst imaginable pain) pain in the last 24 hours:~• on average • at its worst • at its best • right now. Average of these values. Minimum value, 0, maximum value, 10. Higher scores mean a worse outcome. A higher change between the initial visit and the one month visit means a better outcome."
11343558|NCT03888235|OG001|Outcome|Corrective Exercises (SIFFTE) Plus Sacroiliac Belt Use For One Month: Effect on (BPI) Pain Score|All participants fill out the brief pain inventory pain score (BPI) then get the sacroiliac forward flexion test (SIFFT): standing, trunk forward flexed the posterior superior iliac spine levels (PSISL) are found and measured. A higher painful PSIS has anterior, a lower one has posterior malrotation. They are given the appropriate exercise (PSISE) to correct their sacroiliac malrotation. Anterior rotation is corrected with the flexed thigh pushing hard on the anterior superior iliac spine to force it posteriorly. Posterior rotation is corrected by hyperextending the thigh, using the sartorius and the rectus femoris to pull the ilium anteriorly. 3 techniques: - genuflection, anterior side foot and posterior side knee on the floor, hands on either side of the foot, knee stretched backwards, - anterior side foot on chair, pull up on chair to force the thigh against the ilium, - in dorsal decubitus assistant with anterior side foot on their sternum leans forward to push the thigh against ilium and pushes down on extended posterior side thigh to overstretch it. All these are held for 2 minutes. They are then fitted with a sacroiliac stabilization belt to wear as needed for back pain producing activities. They are reassessed one month later at their two month visit once again using the BPI pain score.
11343559|NCT03888235|OG000|Outcome|Immediate Corrective Exercises (SIFFTE)|"The sacroiliac forward flexion test (SIFFT) will determine the level of each posterior superior iliac spine (PSISL). The distance in centimetres between the levels of the PSISs will be recorded. Depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:~Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh.~In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh.~For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium.~Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed with the PSISL one month later.~At that time they will be given the pelvic support belt. The concurrent use of both treatments will be assessed at their last visit one month later using the PSISL."
11348489|NCT04173741|EG001|Reported Event|Leg Rise Position - 1 Minute|"Patients who stayed in passive leg rise position for 1 minute~Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done."
11343560|NCT03888235|OG001|Outcome|Immediate Use of Pelvic Support Belt|"The sacroiliac forward flexion test (SIFFT) will determine the level of each posterior superior iliac spine (PSISL). The distance in centimetres between the levels of the PSISs will be recorded. Following this, participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later with the PSISL.~At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed with the PSISL at their last visit one month later."
11343561|NCT03888235|OG002|Outcome|Delayed Treatment|"The sacroiliac forward flexion test (SIFFT) will determine the level of each posterior superior iliac spine (PSISL). The distance in centimetres between the levels of the PSISs will be recorded. These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the corrective exercise (SIFFTE) and the pelvic support belt after their PSISL has been recorded.~The concurrent use of both treatments will be assessed using the PSISL at their last visit one month after that.~Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention."
11343562|NCT03888235|OG000|Outcome|Baseline Recording of the Distance Between Posterior Superior Iliac Spine Levels (PSISL)|On admission into the study, all participants get the sacroiliac forward flexion test (SIFFT): standing, trunk forward flexed the posterior superior iliac spine (PSIS) levels are found and the distance between them is measured in centimetres.
11343563|NCT03888235|OG001|Outcome|Immediate Corrective Exercises And Use Of Pelvic Stabilization Belt For One Month|At their second visit, one month after the baseline visit, all participants get the sacroiliac forward flexion test (SIFFT): standing, trunk forward flexed the posterior superior iliac spine (PSIS) levels are found and the distance between these is recorded (PSISL). A higher painful PSIS has anterior, a lower one has posterior malrotation. They are given the appropriate exercise to correct their sacroiliac malrotation. Anterior rotation is corrected with the flexed thigh pushing hard on the anterior superior iliac spine to force it posteriorly. Posterior rotation is corrected by hyperextending the thigh, using the sartorius and the rectus femoris to pull the ilium anteriorly. 3 techniques: - genuflection, anterior side foot and posterior side knee on the floor, hands on either side of the foot, knee stretched backwards, - anterior side foot on chair, pull up on chair to force the thigh against the ilium, - in dorsal decubitus assistant with anterior side foot on their sternum leans forward to push the thigh against ilium and pushes down on extended posterior side thigh to overstretch it. All these are held for 2 minutes. They are then fitted with a sacroiliac stabilization belt to wear as needed for back pain producing activities. They are reassessed (PSISL) one month later at their two month visit.
11343564|NCT03888235|OG000|Outcome|Satisfaction With Physiotherapy|Participants joining the study having previously received physiotherapy treatments. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied).
11348490|NCT04169061|BG000|Baseline|All Participants|Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
11348491|NCT04169061|FG000|Participant Flow|All Participants|"Participants receive:~a shot of Acthar (80 units) under the skin twice a week for 12 weeks~a shot of Acthar (40 units) twice a week for 2 weeks~a shot of Acthar (40 units) once a week for 2 more weeks~At each visit they will have medical tests and answer questions about their symptoms."
11348492|NCT04169061|OG000|Outcome|All Participants|Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
11348493|NCT04169061|EG000|Reported Event|All Participants|Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
10845358|NCT00266812|BG001|Baseline|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
10845359|NCT00266812|BG002|Baseline|Total|Total of all reporting groups
11221565|NCT02341859|EG000|Reported Event|Stenfilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
11221566|NCT02341859|EG001|Reported Event|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
11221567|NCT02341859|EG002|Reported Event|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
11221568|NCT02342015|BG000|Baseline|Atorvastatin|Atorvastatin 40 mg/day for three months
11221569|NCT02342015|FG000|Participant Flow|Atorvastatin|"Atorvastatin 40 mg/day for three months~Atorvastatin: Atorvastatin 40mg/day for three months"
11221570|NCT02342015|OG000|Outcome|Atorvastatin|Atorvastatin 40 mg/day for three months
11221571|NCT02342015|EG000|Reported Event|Atorvastatin|Atorvastatin 40 mg/day for three months
10845360|NCT00266812|FG000|Participant Flow|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
11221572|NCT02342171|BG000|Baseline|Convalescent Plasma|"Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg~Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients."
11221573|NCT02342171|BG001|Baseline|Standard Care|The control arm will consist of historical controls having being treated with standard of care
11343565|NCT03888235|OG001|Outcome|Satisfaction With Corrective Exercise (SIFFTE) and Pelvic Belt|"After the sacroiliac forward flexion test (SIFFT) determined the position of each innominate bone, depending on their ability, subjects were given 1 of 3 exercises (SIFFTE) to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. One of 3 different exercises was used depending on the participants' ability to perform them.~The position is held for 2 minutes. They used the exercise as needed for pain control.~Participants were also given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They used this belt for activities which had in the past precipitated back pain.~They were reassessed one month later. At that time, they were asked how satisfied they were with each treatment on a scale from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied) and which treatment they preferred, exercise, belt, both or neither. The score for the preferred therapy was recorded."
11343566|NCT03888235|OG000|Outcome|Satisfaction With Acupuncture|Participants joining the study having previously received acupuncture treatments. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied).
11343567|NCT03888235|OG001|Outcome|Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt|"After the sacroiliac forward flexion test (SIFFT) determined the position of each innominate bone, depending on their ability, subjects were given 1 of 3 exercises (SIFFTE) to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. One of 3 different exercises was used depending on the participants' ability to perform them.~The position is held for 2 minutes. They used the exercise as needed for pain control.~Participants were also given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They used this belt for activities which had in the past precipitated back pain.~They were reassessed one month later. At that time, they were asked how satisfied they were with each treatment on a scale from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied) and which treatment they preferred, exercise, belt, both or neither. The score for the preferred therapy was recorded."
11343568|NCT03888235|OG000|Outcome|Satisfaction With Yoga|Participants joining the study having previously participated in yoga exercises. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied).
11343569|NCT03888235|OG001|Outcome|Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Beltbelt|As part of this study they were given the corrective exercise for their malrotated sacroiliac joint as well as the pelvic stabilization belt and used these for one month. After this month, two months after joining the study, they rated their satisfaction with the corrective exercise (SIFFTE) from 0 - 3 and with the pelvic stabilization belt from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). They were then asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used.
11343570|NCT03888235|OG000|Outcome|Satisfaction With Core Exercises|Participants joining the study having previously participated in core exercises. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied).
11343571|NCT03888235|OG001|Outcome|Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt|As part of this study they were given the corrective exercise (SIFFTE) for their malrotated sacroiliac joint as well as the pelvic stabilization belt and used these for one month. After this month, two months after joining the study, they rated their satisfaction with the corrective exercise (SIFFTE) from 0 - 3 and with the pelvic stabilization belt from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). They were then asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. Wow that's impressive her be and I have done have been 10,802 and 41
11343572|NCT03888235|OG000|Outcome|Satisfaction With the Treatments Received From a Chiropractor|Participants joining the study having previously received chiropractic treatments. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied).
11221574|NCT02342171|BG002|Baseline|Total|Total of all reporting groups
10845361|NCT00266812|FG001|Participant Flow|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
10975795|NCT00937521|EG003|Reported Event|B (Group IV)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting.."
11221575|NCT02342171|FG000|Participant Flow|Convalescent Plasma|"Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg~Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients."
11221576|NCT02342171|FG001|Participant Flow|Standard Care|The control arm will consist of historical controls having being treated with standard of care
11221577|NCT02342171|OG000|Outcome|Convalescent Plasma|"Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg~Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients."
11343573|NCT03888235|OG001|Outcome|Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt|As part of this study they were given the corrective exercise (SIFFTE) for their malrotated sacroiliac joint as well as the pelvic stabilization belt and used these for one month. After this month, two months after joining the study, they rated their satisfaction with the corrective exercise (SIFFTE) from 0 - 3 and with the pelvic stabilization belt from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). They were then asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used.
11343574|NCT03888235|OG000|Outcome|Satisfaction With Massage Therapy|Participants joining the study having previously received massage therapy. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied).
11343575|NCT03888235|EG000|Reported Event|Immediate Corrective Exercises|"After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:~Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh.~In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh.~For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium.~Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later.~At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that."
11343576|NCT03888235|EG001|Reported Event|Immediate Use of Pelvic Support Belt|"Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later.~At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later."
10854163|NCT00322023|FG002|Participant Flow|D Serine 120 mg/kg|Open label, adjunctive to antipsychotics for 4 weeks
10854164|NCT00322023|OG000|Outcome|D-serine 30 mg/kg|4 weeks of adjunctive treatment
10854165|NCT00322023|OG001|Outcome|D-serine 60 mg/kg|4 weeks of adjunctive treatment
10854166|NCT00322023|OG002|Outcome|D Serine 120 mg/kg|4 weeks of adjunctive treatment
10854167|NCT00322023|EG000|Reported Event|D-serine 30 mg/kg|4 weeks of adjunctive treatment
10854168|NCT00322023|EG001|Reported Event|D-serine 60 mg/kg|4 weeks of adjunctive treatment
10854169|NCT00322023|EG002|Reported Event|D Serine 120 mg/kg|4 weeks of adjunctive treatment
10854170|NCT00322049|BG000|Baseline|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854171|NCT00322049|BG001|Baseline|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854172|NCT00322049|BG002|Baseline|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854173|NCT00322049|BG003|Baseline|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
10854174|NCT00322049|BG004|Baseline|Total|Total of all reporting groups
10854175|NCT00322049|FG000|Participant Flow|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854176|NCT00322049|FG001|Participant Flow|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854177|NCT00322049|FG002|Participant Flow|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854178|NCT00322049|FG003|Participant Flow|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
10854179|NCT00322049|OG000|Outcome|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
10854180|NCT00322049|OG001|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854181|NCT00322049|OG002|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854182|NCT00322049|OG000|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854183|NCT00322049|OG001|Outcome|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854184|NCT00322049|OG002|Outcome|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854185|NCT00322049|OG003|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full dose dengue vaccine at study months 0 and 6
10854186|NCT00322049|OG000|Outcome|Control Group|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
10854187|NCT00322049|OG002|Outcome|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854188|NCT00322049|OG003|Outcome|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
10854189|NCT00322049|OG004|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full dose dengue vaccine at study months 0 and 6
10854190|NCT00322049|OG000|Outcome|Subject With Viremia Measured by: RT-PCR|Scheduled phlebotomy and unscheduled phlebotomy when a subject was ill during the study revealed dengue viremia
10854191|NCT00322049|OG001|Outcome|Subject With Viremia Measured by: Nested PCR|Scheduled phlebotomy and unscheduled phlebotomy when a subject was ill during the study revealed dengue viremia
10854192|NCT00322049|EG000|Reported Event|Cohort A: Dengue Vaccine- 1/10 Dose (T-DEN F17 )|Dengue vaccine at Months 0 and 6 and booster follow-up at 3 years;
10854193|NCT00322049|EG001|Reported Event|Cohort B: Full Dose (T-DEN F17 )|Control vaccines: Hemophilus influenza type b (Hib) vaccine and varicella vaccine
10854194|NCT00322049|EG002|Reported Event|Cohort C: Dengue Vaccine - Full Dose (T-DEN F17 )|Dengue vaccine at Months 0 and 6 and booster follow-up at 3 years
10854195|NCT00322049|EG003|Reported Event|Control Group|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
10854196|NCT00322101|BG000|Baseline|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
10854197|NCT00322101|BG001|Baseline|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
10854198|NCT00322101|BG002|Baseline|Total|Total of all reporting groups
10854199|NCT00322101|FG000|Participant Flow|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
11221578|NCT02342171|OG001|Outcome|Standard Care|The control arm will consist of historical controls having being treated with standard of care
11221579|NCT02342171|EG000|Reported Event|Convalescent Plasma|"Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg~Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients.~No data from standard care group available as this is based on historical data."
11221580|NCT02342197|BG000|Baseline|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
11221581|NCT02342197|BG001|Baseline|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
11221582|NCT02342197|BG002|Baseline|Total|Total of all reporting groups
11221583|NCT02342197|FG000|Participant Flow|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
11221584|NCT02342197|FG001|Participant Flow|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
11221585|NCT02342197|OG000|Outcome|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
11221586|NCT02342197|OG001|Outcome|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
11221587|NCT02342197|EG000|Reported Event|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
11221588|NCT02342197|EG001|Reported Event|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
11221589|NCT02342223|BG000|Baseline|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
11221590|NCT02342223|FG000|Participant Flow|Voluma Treatment of HIV Facial Lipoatrophy|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
11221591|NCT02342223|OG000|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
10854200|NCT00322101|FG001|Participant Flow|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
10854201|NCT00322101|OG000|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
10854202|NCT00322101|OG001|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
10854203|NCT00322101|EG000|Reported Event|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
10854204|NCT00322101|EG001|Reported Event|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
10854205|NCT00322153|BG000|Baseline|Placebo|Matching placebo oral administration once daily for 24 weeks.
10854206|NCT00322153|BG001|Baseline|Memantine ER|28mg once daily oral administration for 24 weeks.
10854207|NCT00322153|BG002|Baseline|Total|Total of all reporting groups
10854208|NCT00322153|FG000|Participant Flow|Placebo|Matching placebo oral administration once daily for 24 weeks.
10854209|NCT00322153|FG001|Participant Flow|Memantine ER|28mg once daily oral administration for 24 weeks.
10854210|NCT00322153|OG000|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
10854211|NCT00322153|OG001|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
10854212|NCT00322153|EG000|Reported Event|Placebo|Matching placebo oral administration once daily for 24 weeks.
10854213|NCT00322153|EG001|Reported Event|Memantine ER|28mg once daily oral administration for 24 weeks.
10854214|NCT00322231|BG000|Baseline|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
10854215|NCT00322231|BG001|Baseline|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
10854216|NCT00322231|BG002|Baseline|Total|Total of all reporting groups
10854217|NCT00322231|FG000|Participant Flow|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
10854218|NCT00322231|FG001|Participant Flow|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
10854219|NCT00322231|OG000|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
10854220|NCT00322231|OG001|Outcome|Placebo|Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
10854221|NCT00322231|OG000|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included.
10854222|NCT00322231|OG001|Outcome|Placebo|Participants who received placebo (at Day 1) in Placebo / ZOSTAVAX™ group. Participants who received ZOSTAVAX™ at (Day 1) in the ZOSTAVAX™ / Placebo group were excluded to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements.
10854223|NCT00322231|OG000|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group are included. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
10854224|NCT00322231|OG001|Outcome|Placebo|Participants included in this analysis were those who received Placebo in Placebo /ZOSTAVAX™ group (on Day 1). Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group were excluded in order to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
10854225|NCT00322231|EG000|Reported Event|ZOSTAVAX™|All participants that received ZOSTAVAX™ from both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group. Two participants that received ZOSTAVAX™ were lost to follow up and not included in the analysis.
11221592|NCT02342223|EG000|Reported Event|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
11221593|NCT02342288|BG000|Baseline|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
11221594|NCT02342288|BG001|Baseline|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
11221595|NCT02342288|BG002|Baseline|Total|Total of all reporting groups
11221596|NCT02342288|FG000|Participant Flow|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
11221597|NCT02342288|FG001|Participant Flow|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
11221598|NCT02342288|OG000|Outcome|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Five minutes after turning prone, an IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes an IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
11221599|NCT02342288|OG001|Outcome|Head in Neutral Position|"Head in neutral position~Head in neutral position: Five minutes after turning prone, an IOP measurement was obtained. After 5 minutes an IOP measurement was taken. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
11221600|NCT02342288|EG000|Reported Event|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
11221601|NCT02342288|EG001|Reported Event|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
11221602|NCT02342314|BG000|Baseline|LY3143753 (Part A)|Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1.
11221603|NCT02342314|BG001|Baseline|LY3185643 (Part B)|Single SC injection of ascending doses of LY3185643 on Day 1.
11221604|NCT02342314|BG002|Baseline|Total|Total of all reporting groups
11221605|NCT02342314|FG000|Participant Flow|Placebo (Part A)|Single subcutaneous (SC) injection of normal saline on Day 1.
11221606|NCT02342314|FG001|Participant Flow|0.05 mg of LY3143753 (Part A)|Part A: 0.05 milligram (mg) of LY3143753 given as a single SC injection on Day 1.
11221607|NCT02342314|FG002|Participant Flow|0.1 mg of LY3143753 (Part A)|Part A: 0.1 mg of LY3143753 given as a single SC injection on Day 1.
11221608|NCT02342314|FG003|Participant Flow|0.2 mg of LY3143753 (Part A)|Part A: 0.2 mg of LY3143753 given as a single SC injection on Day 1.
10975796|NCT00937521|EG004|Reported Event|½ (B+OMV) (Group V)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
10854226|NCT00322231|EG001|Reported Event|Placebo|All participants that received Placebo in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™. Five participants that received placebo were lost to follow up and not included in the analysis.
11221609|NCT02342314|FG004|Participant Flow|0.4 mg of LY3143753 (Part A)|Part A: 0.4 mg of LY3143753 given as a single SC injection on Day 1.
11221610|NCT02342314|FG005|Participant Flow|1.0 mg of LY3143753 (Part A)|Part A: 1.0 mg of LY3143753 given as a SC injection on Day 1.
11221611|NCT02342314|FG006|Participant Flow|Placebo (Part B)|Part B: Single SC injection of normal saline on Day 1.
11221612|NCT02342314|FG007|Participant Flow|0.01 mg of LY3185643 (Part B)|Part B: 0.01 mg of LY3185643 given as a single SC injection on Day 1.
10854227|NCT00322309|BG000|Baseline|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
10854228|NCT00322309|BG001|Baseline|Placebo|Subjects received matched placebo capsules
10854229|NCT00322309|BG002|Baseline|Total|Total of all reporting groups
10854230|NCT00322309|FG000|Participant Flow|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
10854231|NCT00322309|FG001|Participant Flow|Placebo|Matched placebo given daily days 1-84
10854232|NCT00322309|OG000|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
10854233|NCT00322309|OG001|Outcome|Placebo|Subjects received matched placebo capsules
10854234|NCT00322309|OG000|Outcome|Mirtazepine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
10854235|NCT00322309|OG001|Outcome|Placebo|Matched placebo capsules
10854236|NCT00322309|OG001|Outcome|Placebo|Matched placebo given daily days 1-84
10854237|NCT00322309|EG000|Reported Event|Mirtazapine Daily: Days 1-4 15mg Days 5-9 30mg Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
10854238|NCT00322309|EG001|Reported Event|Placebo|Matched placebo
10854239|NCT00322335|BG000|Baseline|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
10854240|NCT00322335|BG001|Baseline|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
10854241|NCT00322335|BG002|Baseline|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
10854242|NCT00322335|BG003|Baseline|Total|Total of all reporting groups
10854243|NCT00322335|FG000|Participant Flow|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
10854244|NCT00322335|FG001|Participant Flow|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
10854245|NCT00322335|FG002|Participant Flow|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
10854246|NCT00322335|OG000|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
10878871|NCT00454636|OG001|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
11221613|NCT02342314|FG008|Participant Flow|0.03 mg of LY3185643 (Part B)|Part B: 0.03 mg of LY3185643 given as a single SC injection on Day 1.
11221614|NCT02342314|FG009|Participant Flow|0.05 mg of LY3185643 (Part B)|Part B: 0.05 mg of LY3185643 given as a single SC injection on Day 1.
11221615|NCT02342314|FG010|Participant Flow|0.06 mg of LY3185643 (Part B)|Part B: 0.06 mg of LY3185643 given as a single SC injection on Day 1.
11221616|NCT02342314|FG011|Participant Flow|0.1 mg of LY3185643 (Part B)|Part B: 0.1 mg of LY3185643 given as a single SC injection on Day 1.
11221617|NCT02342314|FG012|Participant Flow|0.2 mg of LY3185643 (Part B)|Part B: 0.2 mg of LY3185643 given as a single SC injection on Day 1.
11221618|NCT02342314|FG013|Participant Flow|0.3 mg of LY3185643 (Part B)|Part B: 0.3 mg of LY3185643 given as a single SC injection on Day 1.
11221619|NCT02342314|FG014|Participant Flow|0.48 mg of LY3185643 (Part B)|Part B: 0.48 mg of LY3185643 given as a single SC injection on Day 1.
11221620|NCT02342314|FG015|Participant Flow|0.72 mg of LY3185643 (Part B)|Part B: 0.72 mg of LY3185643 given as a single SC injection on Day 1.
11221621|NCT02342314|FG016|Participant Flow|rGlucagon (Part B)|Part B: 1.0 mg of rGlucagon given as a single SC injection. (Part B).
11221622|NCT02342314|OG000|Outcome|Placebo (Part A)|Single SC injection on Day 1.
11221623|NCT02342314|OG001|Outcome|0.05 mg of LY3143753 (Part A)|0.05 mg of LY3143753 given as a single SC injection.
11221624|NCT02342314|OG002|Outcome|0.1 mg of LY3143753 (Part A)|0.1 mg of LY3143753 given as a single SC injection.
11221625|NCT02342314|OG003|Outcome|0.2 mg of LY3143753 (Part A)|0.2 mg of LY3143753 given as a single SC injection.
11221626|NCT02342314|OG004|Outcome|0.4 mg of LY3143753 (Part A)|0.4 mg of LY3143753 given as a single SC injection.
11221627|NCT02342314|OG005|Outcome|1 mg of LY3143753 (Part A)|1 mg of LY3143753 given as a single SC injection.
11221628|NCT02342314|OG006|Outcome|Placebo (Part B)|Single SC injection on Day 1.
11343577|NCT03888235|EG002|Reported Event|Delayed Treatment|"These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt.~The concurrent use of both treatments will be assessed at their last visit one month after that.~Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention."
11343578|NCT03889158|BG000|Baseline|Older Adults|Individuals 55-75 years of age
11343579|NCT03889158|BG001|Baseline|Younger Adults|Individuals 18-35 years of age
11343580|NCT03889158|BG002|Baseline|Total|Total of all reporting groups
11343581|NCT03889158|FG000|Participant Flow|Older Adults|Individuals 55-75 years of age.
11343582|NCT03889158|FG001|Participant Flow|Younger Adults|Individuals 18-35 years of age
11343583|NCT03889158|OG000|Outcome|Older Adults|Individuals 55-75 years of age
11343584|NCT03889158|OG001|Outcome|Younger Adults|Individuals 18-35 years of age
11343585|NCT03889158|OG000|Outcome|Older Adults|Individuals 55-75 years of age.
11343586|NCT03889158|EG000|Reported Event|Older Adults|Individuals 55-75 years of age
11343587|NCT03889158|EG001|Reported Event|Younger Adults|Individuals 18-35 years of age
10845362|NCT00266812|OG000|Outcome|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
11221629|NCT02342314|OG007|Outcome|0.01 mg of LY3185643 (Part B)|0.01 mg of LY3185643 given as a single SC injection on Day 1.
11221630|NCT02342314|OG008|Outcome|0.03 mg of LY3185643 (Part B)|0.03 mg of LY3185643 given as a single SC injection on Day 1.
11221631|NCT02342314|OG009|Outcome|0.05 mg of LY3185643 (Part B)|0.05 mg of LY3185643 given as a single SC injection on Day 1.
11221632|NCT02342314|OG010|Outcome|0.06 mg of LY3185643 (Part B)|0.06 mg of LY3185643 given as a single SC injection on Day 1.
11221633|NCT02342314|OG011|Outcome|0.1 mg of LY3185643 (Part B)|0.1 mg of LY3185643 given as a single SC injection on Day 1.
11221634|NCT02342314|OG012|Outcome|0.2 mg of LY3185643 (Part B)|0.2 mg of LY3185643 given as a single SC injection on Day 1.
11221635|NCT02342314|OG013|Outcome|0.3 mg of LY3185643 (Part B)|0.3 mg of LY3185643 given as a single SC injection on Day 1.
11343588|NCT03890419|BG000|Baseline|Control Group|"Control Group participants will be exposed to full spectrum light during the study.~Clear light: Full spectrum light exposure"
11343589|NCT03890419|BG001|Baseline|Green Light Group|"Green light Group participants will be exposed to green light during the study.~Green light: Green light exposure"
11343590|NCT03890419|BG002|Baseline|Blue Light Group|"Blue light Group participants will be exposed to blue light during the study.~Blue Light: Blue light exposure"
11343591|NCT03890419|BG003|Baseline|Total|Total of all reporting groups
11343592|NCT03890419|FG000|Participant Flow|Control Group|"Control Group participants will be exposed to full spectrum light during the study.~Clear light: Full spectrum light exposure"
11343593|NCT03890419|FG001|Participant Flow|Green Light Group|"Green light Group participants will be exposed to green light during the study.~Green light: Green light exposure"
11343594|NCT03890419|FG002|Participant Flow|Blue Light Group|"Blue light Group participants will be exposed to blue light during the study.~Blue Light: Blue light exposure"
11343595|NCT03890419|OG000|Outcome|Control Group|"Control Group participants will be exposed to full spectrum light during the study.~Clear light: Full spectrum light exposure"
11343596|NCT03890419|OG001|Outcome|Green Light Group|"Green light Group participants will be exposed to green light during the study.~Green light: Green light exposure"
11343597|NCT03890419|OG002|Outcome|Blue Light Group|"Blue light Group participants will be exposed to blue light during the study.~Blue Light: Blue light exposure"
11343598|NCT03890419|EG000|Reported Event|Control Group|"Control Group participants will be exposed to full spectrum light during the study.~Clear light: Full spectrum light exposure"
11343599|NCT03890419|EG001|Reported Event|Green Light Group|"Green light Group participants will be exposed to green light during the study.~Green light: Green light exposure"
11343600|NCT03890419|EG002|Reported Event|Blue Light Group|"Blue light Group participants will be exposed to blue light during the study.~Blue Light: Blue light exposure"
11221636|NCT02342314|OG014|Outcome|Part B 0.48 mg of LY3185643|0.48 mg of LY3185643 given as a single SC injection on Day 1.
11221637|NCT02342314|OG015|Outcome|0.72 mg of LY3185643 (Part B)|0.72 mg of LY3185643 given as a single SC injection on Day 1.
11221638|NCT02342314|OG016|Outcome|r Glucagon (Part B)|1 mg of rGlucagon given as a single SC injection. (Part B).
11221639|NCT02342314|OG000|Outcome|0.05 mg of LY3143753 (Part A)|0.05 mg of LY3143753 given as a single SC injection on Day 1.
11221640|NCT02342314|OG001|Outcome|0.1 mg of LY3143753 (Part A)|0.1 mg of LY3143753 given as a single SC injection on Day 1.
11221641|NCT02342314|OG002|Outcome|0.2 mg of LY3143753 (Part A)|0.2 mg of LY3143753 given as a single SC injection on Day 1.
11221642|NCT02342314|OG003|Outcome|0.4 mg of LY3143753 (Part A)|0.4 mg of LY3143753 given as a single SC injection on Day 1.
11221643|NCT02342314|OG004|Outcome|1.0 mg of LY3143753 (Part A)|1.0 mg of LY3143753 given as a single SC injection on Day 1.
11221644|NCT02342314|OG000|Outcome|0.01 mg of LY3185643 (Part B)|0.01 mg of LY3185643 given as a single SC injection on Day 1.
11221645|NCT02342314|OG001|Outcome|0.03 mg of LY3185643 (Part B)|0.03 mg of LY3185643 given as a single SC injection on Day 1.
11221646|NCT02342314|OG002|Outcome|0.05 mg of LY3185643 (Part B)|0.05 mg of LY3185643 given as a single SC injection on Day 1.
11221647|NCT02342314|OG003|Outcome|0.06 mg of LY3185643 (Part B)|0.06 mg of LY3185643 given as a single SC injection on Day 1.
11221648|NCT02342314|OG004|Outcome|0.1 mg of LY3185643 (Part B)|0.1 mg of LY3185643 given as a single SC injection on Day 1.
11221649|NCT02342314|OG005|Outcome|0.2 mg of LY3185643 (Part B)|0.2 mg of LY3185643 given as a single SC injection on Day 1.
11221650|NCT02342314|OG006|Outcome|0.3 mg of LY3185643 (Part B)|0.3 mg of LY3185643 given as a single SC injection on Day 1.
11221651|NCT02342314|OG007|Outcome|0.48 mg of LY3185643 (Part B)|0.48 mg of LY3185643 given as a single SC injection on Day 1.
11221652|NCT02342314|OG008|Outcome|0.72 mg of LY3185643 (Part B)|0.72 mg of LY3185643 given as a single SC injection on Day 1.
11221653|NCT02342314|OG000|Outcome|Placebo (Part A)|Single SC injection of normal saline on Day 1.
11221654|NCT02342314|OG001|Outcome|0.05 mg of LY3143753 (Part A)|0.05 mg of LY3143753 given as a single SC injection on Day 1.
10845363|NCT00266812|OG001|Outcome|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
11221655|NCT02342314|OG002|Outcome|0.1 mg of LY3143753 (Part A)|0.1 mg of LY3143753 given as a single SC injection on Day 1.
11221656|NCT02342314|OG003|Outcome|0.2 mg of LY3143753 (Part A)|0.2 mg of LY3143753 given as a single SC injection on Day 1.
11221657|NCT02342314|OG004|Outcome|0.4 mg of LY3143753 (Part A)|0.4 mg of LY3143753 given as a single SC injection on Day 1.
11221658|NCT02342314|OG005|Outcome|1.0 mg of LY3143753 (Part A)|1.0 mg of LY3143753 given as a single SC injection on Day 1.
11221659|NCT02342314|OG000|Outcome|Placebo (Part B)|Single SC injection of normal saline on Day 1.
11221660|NCT02342314|OG001|Outcome|0.01 mg of LY3185643 (Part B)|0.01 mg of LY3185643 given as a single SC injection on Day 1.
11221661|NCT02342314|OG002|Outcome|0.03 mg of LY3185643 (Part B)|0.03 mg of LY3185643 given as a single SC injection on Day 1.
11221662|NCT02342314|OG003|Outcome|0.05 mg of LY3185643 (Part B)|0.05 mg of LY3185643 given as a single SC injection on Day 1.
11221663|NCT02342314|OG004|Outcome|0.06 mg of LY3185643 (Part B)|0.06 mg of LY3185643 given as a single SC injection on Day 1.
11221664|NCT02342314|OG005|Outcome|0.1 mg of LY3185643 (Part B)|0.1 mg of LY3185643 given as a single SC injection on Day 1.
11221665|NCT02342314|OG006|Outcome|0.2 mg of LY3185643 (Part B)|0.2 mg of LY3185643 given as a single SC injection on Day 1.
11221666|NCT02342314|OG007|Outcome|0.3 mg of LY3185643 (Part B)|0.3 mg of LY3185643 given as a single SC injection on Day 1.
11221667|NCT02342314|OG008|Outcome|0.48 mg of LY3185643 (Part B)|0.48 mg of LY3185643 given as a single SC injection on Day 1.
11221668|NCT02342314|OG009|Outcome|Part B 0.72 mg of LY3185643 (Part B)|0.72 mg of LY3185643 given as a single SC injection on Day 1.
11221669|NCT02342314|OG010|Outcome|1.0 mg of rGlucagon (Part B)|1.0 mg of rGlucagon given as a single SC injection.
11221670|NCT02342314|OG009|Outcome|0.72 mg of LY3185643 (Part B)|0.72 mg of LY3185643 given as a single SC injection on Day 1.
11221671|NCT02342314|OG010|Outcome|1.0 mg of rGlucagon (Part B)|1.0 mg of rGlucagon given as a single SC injection. (Part B).
11221672|NCT02342314|OG002|Outcome|0.1 mg of LY3143753 (Part A)|0.01 mg of LY3143753 given as a single SC injection on Day 1.
11221673|NCT02342314|OG010|Outcome|rGlucagon (Part B)|1 mg of rGlucagon given as a single SC injection. (Part B).
11221674|NCT02342314|EG000|Reported Event|Placebo (Part A)|Single SC injection on Day 1.
11221675|NCT02342314|EG001|Reported Event|0.05 mg of LY3143753 (Part A)|0.05 mg of LY3143753 given as a single SC injection.
11221676|NCT02342314|EG002|Reported Event|0.1 mg of LY3143753 (Part A)|0.1 mg of LY3143753 given as a single SC injection.
11221677|NCT02342314|EG003|Reported Event|0.2 mg of LY3143753 (Part A)|0.2 mg of LY3143753 given as a single SC injection.
11221678|NCT02342314|EG004|Reported Event|0.4 mg of LY3143753 (Part A)|0.4 mg of LY3143753 given as a single SC injection.
11221679|NCT02342314|EG005|Reported Event|1 mg of LY3143753 (Part A)|1 mg of LY3143753 given as a single SC injection.
11221680|NCT02342314|EG006|Reported Event|Placebo (Part B)|Single SC injection on Day 1.
11221681|NCT02342314|EG007|Reported Event|0.01 mg of LY3185643 (Part B)|0.01 mg of LY3185643 given as a single SC injection on Day 1.
10878872|NCT00454636|OG002|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
11221682|NCT02342314|EG008|Reported Event|0.03 mg of LY3185643 (Part B)|0.03 mg of LY3185643 given as a single SC injection on Day 1.
11221683|NCT02342314|EG009|Reported Event|0.05 mg of LY3185643 (Part B)|0.05 mg of LY3185643 given as a single SC injection on Day 1.
11221684|NCT02342314|EG010|Reported Event|0.06 mg of LY3185643 (Part B)|0.06 mg of LY3185643 given as a single SC injection on Day 1.
11221685|NCT02342314|EG011|Reported Event|0.1 mg of LY3185643 (Part B)|0.1 mg of LY3185643 given as a single SC injection on Day 1.
11221686|NCT02342314|EG012|Reported Event|0.2 mg of LY3185643 (Part B)|0.2 mg of LY3185643 given as a single SC injection on Day 1.
11221687|NCT02342314|EG013|Reported Event|0.3 mg of LY3185643 (Part B)|0.3 mg of LY3185643 given as a single SC injection on Day 1.
11221688|NCT02342314|EG014|Reported Event|Part B 0.48 mg of LY3185643|0.48 mg of LY3185643 given as a single SC injection on Day 1.
11221689|NCT02342314|EG015|Reported Event|0.72 mg of LY3185643 (Part B)|0.72 mg of LY3185643 given as a single SC injection on Day 1.
11221690|NCT02342314|EG016|Reported Event|r Glucagon (Part B)|1 mg of rGlucagon given as a single SC injection. (Part B).
11221691|NCT02342327|BG000|Baseline|Continue Smoking Menthol Cigarettes|"Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking~continue smoking menthol cigarettes prior to cessation attempt"
11221692|NCT02342327|BG001|Baseline|Switch to Non-menthol Cigarettes|"Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking~switch to non-menthol cigarettes prior to cessation attempt"
11221693|NCT02342327|BG002|Baseline|Total|Total of all reporting groups
11221694|NCT02342327|FG000|Participant Flow|Continue Smoking Menthol Cigarettes|"Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking~continue smoking menthol cigarettes prior to cessation attempt"
11221695|NCT02342327|FG001|Participant Flow|Switch to Non-menthol Cigarettes|"Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking~switch to non-menthol cigarettes prior to cessation attempt"
11221696|NCT02342327|OG000|Outcome|Continue Smoking Menthol Cigarettes|"Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking~continue smoking menthol cigarettes prior to cessation attempt"
11221697|NCT02342327|OG001|Outcome|Switch to Non-menthol Cigarettes|"Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking~switch to non-menthol cigarettes prior to cessation attempt"
10854247|NCT00322335|OG001|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
10854248|NCT00322335|OG002|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
10854249|NCT00322335|EG000|Reported Event|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
10854250|NCT00322335|EG001|Reported Event|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
10854251|NCT00322335|EG002|Reported Event|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
10854252|NCT00322348|BG000|Baseline|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
11221698|NCT02342327|EG000|Reported Event|Continue Smoking Menthol Cigarettes|"Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking~continue smoking menthol cigarettes prior to cessation attempt"
10854253|NCT00322348|BG001|Baseline|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
10854254|NCT00322348|BG002|Baseline|Total|Total of all reporting groups
11221699|NCT02342327|EG001|Reported Event|Switch to Non-menthol Cigarettes|"Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking~switch to non-menthol cigarettes prior to cessation attempt"
11221700|NCT02342379|BG000|Baseline|Bevacizumab and TH-302|"Patients will be treated with combination of bevacizumab and TH-302.~Bevacizumab: 10mg/kg~TH-302: 670mg/m2"
11221701|NCT02342379|FG000|Participant Flow|Bevacizumab and TH-302|"Patients will be treated with combination of bevacizumab and TH-302.~Bevacizumab: 10mg/kg~TH-302: 670mg/m2"
11221702|NCT02342379|OG000|Outcome|Bevacizumab and TH-302|"Patients will be treated with combination of bevacizumab and TH-302.~Bevacizumab: 10mg/kg~TH-302: 670mg/m2"
11221703|NCT02342379|EG000|Reported Event|Bevacizumab and TH-302|"Patients will be treated with combination of bevacizumab and TH-302.~Bevacizumab: 10mg/kg~TH-302: 670mg/m2"
11221704|NCT02342418|BG000|Baseline|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
10854255|NCT00322348|FG000|Participant Flow|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
10854256|NCT00322348|FG001|Participant Flow|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
10854257|NCT00322348|OG000|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
10854258|NCT00322348|OG001|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
11221705|NCT02342418|BG001|Baseline|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
11221706|NCT02342418|BG002|Baseline|Total|Total of all reporting groups
11221707|NCT02342418|FG000|Participant Flow|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
11221708|NCT02342418|FG001|Participant Flow|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
11221709|NCT02342418|OG000|Outcome|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
10854259|NCT00322348|EG000|Reported Event|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
11221710|NCT02342418|OG001|Outcome|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
11221711|NCT02342418|EG000|Reported Event|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
11221712|NCT02342418|EG001|Reported Event|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
11221713|NCT02342535|BG000|Baseline|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.~The participant's children between the ages of 6 and 14 years will participate in the martial arts and yoga class with their mothers.~Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
11221714|NCT02342535|FG000|Participant Flow|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.~The participant's children between the ages of 6 and 14 years will participate in the martial arts class with the mothers.~Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
11221715|NCT02342535|OG000|Outcome|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.~The participant's children between the ages of 6 and 14 years will participate in the kids exercise class with their mothers.~Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
11221716|NCT02342535|EG000|Reported Event|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.~The participant's children between the ages of 6 and 14 years will participate in the kids exercise class with their mothers.~Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
11221717|NCT02342548|BG000|Baseline|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
11221718|NCT02342548|BG001|Baseline|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
11221719|NCT02342548|BG002|Baseline|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
11221720|NCT02342548|BG003|Baseline|Total|Total of all reporting groups
10854260|NCT00322348|EG001|Reported Event|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
10854261|NCT00322374|BG000|Baseline|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854262|NCT00322374|BG001|Baseline|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
11221721|NCT02342548|FG000|Participant Flow|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
11221722|NCT02342548|FG001|Participant Flow|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
11343617|NCT03900416|BG000|Baseline|Mindfulness App|"Guided mindfulness exercises will be delivered via mobile app for three weeks.~Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction."
10854263|NCT00322374|BG002|Baseline|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854264|NCT00322374|BG003|Baseline|Total|Total of all reporting groups
10854265|NCT00322374|FG000|Participant Flow|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854266|NCT00322374|FG001|Participant Flow|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854267|NCT00322374|FG002|Participant Flow|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
11221723|NCT02342548|FG002|Participant Flow|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
10854268|NCT00322374|FG003|Participant Flow|All Participants|
10854269|NCT00322374|OG000|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854270|NCT00322374|OG001|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854271|NCT00322374|OG002|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
11221724|NCT02342548|OG000|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
11221725|NCT02342548|OG001|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
10854272|NCT00322374|OG000|Outcome|All Participants With Measurable Disease and Tumor Response|All participants received Ixabepilone administered as a 3-hour IV infusion following a 3- to 5-minute IV infusion of Epirubicin every 21 days.
10854273|NCT00322374|OG000|Outcome|All Participants With Measurable Disease|Participants with measurable disease at baseline per RECIST
10854274|NCT00322374|OG001|Outcome|All Response-evaluable Participants|Participants treated at the MTD with measurable disease at baseline per RECIST
10854275|NCT00322374|OG000|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
10854276|NCT00322374|OG001|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
10854277|NCT00322374|EG000|Reported Event|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854278|NCT00322374|EG001|Reported Event|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854279|NCT00322374|EG002|Reported Event|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
10854280|NCT00322387|BG000|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
10854281|NCT00322387|BG001|Baseline|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
10854282|NCT00322387|BG002|Baseline|Total|Total of all reporting groups
10854283|NCT00322387|FG000|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
10854284|NCT00322387|FG001|Participant Flow|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
10854285|NCT00322387|OG000|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
10854286|NCT00322387|OG001|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
11221726|NCT02342548|OG002|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
11343618|NCT03900416|BG001|Baseline|Control Condition|Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
10854287|NCT00322387|OG002|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
10854288|NCT00322387|OG003|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
10854289|NCT00322387|OG004|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
10854290|NCT00322387|OG005|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
10854291|NCT00322387|OG006|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
10854292|NCT00322387|OG007|Outcome|All Participants|
10854293|NCT00322387|EG000|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
10854294|NCT00322387|EG001|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
10854295|NCT00322387|EG002|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
10854296|NCT00322387|EG003|Reported Event|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
10854297|NCT00322387|EG004|Reported Event|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
10854298|NCT00322387|EG005|Reported Event|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|"Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen.~Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days."
10878873|NCT00454636|OG003|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
10975797|NCT00937521|EG005|Reported Event|PH2 B+OMV (Group VI)|"SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
11221727|NCT02342548|EG000|Reported Event|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
11221728|NCT02342548|EG001|Reported Event|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
11221729|NCT02342548|EG002|Reported Event|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
11221730|NCT02342561|BG000|Baseline|Intervention Knees (Draped Knees) and Control Knees (No-draped|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.~The knee that is not drape is left uncovered during the intervention."
11221731|NCT02342561|FG000|Participant Flow|Intervention Knee (Drape Side) and Control Knee (No Drape Side|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.~The control knee that is not drape is left uncovered during the intervention."
11221732|NCT02342561|OG000|Outcome|Intervention Knee (Draped Knees)|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
11221733|NCT02342561|OG001|Outcome|Control Knee (No-drape Knees)|The knee that is not drape is left uncovered during the intervention.
11221734|NCT02342561|OG000|Outcome|Intervention Knees (Drape Side)|"One knee of the patient were randomly selected to be draped with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
11221735|NCT02342561|OG001|Outcome|Control Knees (No-drape Side)|The knees were not drape were left uncovered during the intervention.
11221736|NCT02342561|EG000|Reported Event|Intervention Knees|"One knee of the patient were randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
11221737|NCT02342561|EG001|Reported Event|Control Knees|The knees that were not drape is left uncovered during the intervention.
11221738|NCT02342639|BG000|Baseline|Rifaximin|"Participants will receive a 10-day course of Rifaximin.~Rifaximin: 550mg PO BID"
11221739|NCT02342639|BG001|Baseline|Placebo|"Participants will receive a 10-day course of placebo.~Placebo: Placebo PO BID"
11221740|NCT02342639|BG002|Baseline|Total|Total of all reporting groups
10845364|NCT00266812|EG000|Reported Event|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
11221741|NCT02342639|FG000|Participant Flow|Rifaximin|"Participants will receive a 10-day course of Rifaximin 550mg PO BID.~Rifaximin: 550mg pills"
11221742|NCT02342639|FG001|Participant Flow|Placebo|"Participants will receive a 10-day course of placebo PO BID.~Placebo: Placebo pill"
11221743|NCT02342639|OG000|Outcome|Rifaximin|"Participants will receive a 10-day course of Rifaximin.~Rifaximin: 550mg pills"
11221744|NCT02342639|OG001|Outcome|Placebo|"Participants will receive a 10-day course of placebo.~Placebo: Placebo pill"
11221745|NCT02342639|OG000|Outcome|Rifaximin|"Participants will receive a 10-day course of Rifaximin 550mg PO BID.~Rifaximin: 550mg pills"
11221746|NCT02342639|OG001|Outcome|Placebo|"Participants will receive a 10-day course of placebo PO BID.~Placebo: Placebo pill"
11221747|NCT02342639|EG000|Reported Event|Rifaximin|"Participants will receive a 10-day course of Rifaximin 550mg PO BID.~Rifaximin: 550mg pills"
11221748|NCT02342639|EG001|Reported Event|Placebo|"Participants will receive a 10-day course of placebo PO BID.~Placebo: Placebo pill"
11221749|NCT02342678|BG000|Baseline|Yoga Therapy Group|"Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.~Yoga Therapy"
11221750|NCT02342678|BG001|Baseline|Physical Conditioning Group|"Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.~Physical Conditioning"
11221751|NCT02342678|BG002|Baseline|Total|Total of all reporting groups
11221752|NCT02342678|FG000|Participant Flow|Yoga Therapy Group|"Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.~Yoga Therapy"
11343619|NCT03900416|BG002|Baseline|Total|Total of all reporting groups
11221753|NCT02342678|FG001|Participant Flow|Physical Conditioning Group|"Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.~Physical Conditioning"
11221754|NCT02342678|OG000|Outcome|Yoga Therapy Group|"Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.~Yoga Therapy"
11221755|NCT02342678|OG001|Outcome|Physical Conditioning Group|"Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.~Physical Conditioning"
11221756|NCT02342678|EG000|Reported Event|Yoga Therapy Group|"Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.~Yoga Therapy"
11221757|NCT02342678|EG001|Reported Event|Physical Conditioning Group|"Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.~Physical Conditioning"
11221758|NCT02342704|BG000|Baseline|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
11221759|NCT02342704|BG001|Baseline|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
11221760|NCT02342704|BG002|Baseline|Total|Total of all reporting groups
11221761|NCT02342704|FG000|Participant Flow|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
11221762|NCT02342704|FG001|Participant Flow|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
11221763|NCT02342704|OG000|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
11221764|NCT02342704|OG001|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
11221765|NCT02342704|EG000|Reported Event|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
11221766|NCT02342704|EG001|Reported Event|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
11221767|NCT02342743|BG000|Baseline|Active|"Daily trigeminal nerve stimulation session of 20 minutes with CEFALY~CEFALY"
11221768|NCT02342743|FG000|Participant Flow|Active|"Daily trigeminal nerve stimulation session of 20 minutes with CEFALY~CEFALY"
11221769|NCT02342743|OG000|Outcome|Active|"Daily trigeminal nerve stimulation session of 20 minutes with CEFALY~CEFALY"
11221770|NCT02342743|EG000|Reported Event|Active|"Daily trigeminal nerve stimulation session of 20 minutes with CEFALY~CEFALY"
11221771|NCT02342886|BG000|Baseline|DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
11343620|NCT03900416|FG000|Participant Flow|Mindfulness App|"Guided mindfulness exercises will be delivered via mobile app for three weeks.~Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction."
10845365|NCT00266812|EG001|Reported Event|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
10845366|NCT00266825|BG000|Baseline|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
10845367|NCT00266825|BG001|Baseline|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
10845368|NCT00266825|BG002|Baseline|Total|Total of all reporting groups
10845369|NCT00266825|FG000|Participant Flow|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
10845370|NCT00266825|FG001|Participant Flow|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
10845371|NCT00266825|OG000|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
11221772|NCT02342886|BG001|Baseline|DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
11221773|NCT02342886|BG002|Baseline|DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
11221774|NCT02342886|BG003|Baseline|DS-TB: 2 Months HRZE / 4 Months HR|Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
11221775|NCT02342886|BG004|Baseline|MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
11221776|NCT02342886|BG005|Baseline|Total|Total of all reporting groups
11343621|NCT03900416|FG001|Participant Flow|Control Condition|Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
11221777|NCT02342886|FG000|Participant Flow|DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 milligrams (mg) moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
11221778|NCT02342886|FG001|Participant Flow|DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
11221779|NCT02342886|FG002|Participant Flow|DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
11221780|NCT02342886|FG003|Participant Flow|DS-TB: 2 Months HRZE / 4 Months HR|Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
11221781|NCT02342886|FG004|Participant Flow|MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
11221782|NCT02342886|OG000|Outcome|DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
10854299|NCT00322387|EG006|Reported Event|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
10854300|NCT00322439|BG000|Baseline|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
10854301|NCT00322439|FG000|Participant Flow|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
10854302|NCT00322439|OG000|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
10854303|NCT00322439|EG000|Reported Event|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
10854304|NCT00322452|BG000|Baseline|Gefitinib|Gefitinib 250mg daily
10854305|NCT00322452|BG001|Baseline|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
10854306|NCT00322452|BG002|Baseline|Total|Total of all reporting groups
10854307|NCT00322452|FG000|Participant Flow|Gefitinib|Gefitinib 250mg daily
10854308|NCT00322452|FG001|Participant Flow|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
10854309|NCT00322452|OG000|Outcome|Gefitinib|Gefitinib 250mg daily
10854310|NCT00322452|OG001|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
10854311|NCT00322452|EG000|Reported Event|Gefitinib|Gefitinib 250mg daily
10854312|NCT00322452|EG001|Reported Event|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
10854313|NCT00322465|BG000|Baseline|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
10854314|NCT00322465|BG001|Baseline|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
10854315|NCT00322465|BG002|Baseline|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
10854316|NCT00322465|BG003|Baseline|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
10854317|NCT00322465|BG004|Baseline|Total|Total of all reporting groups
10854318|NCT00322465|FG000|Participant Flow|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
10854319|NCT00322465|FG001|Participant Flow|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
10854320|NCT00322465|FG002|Participant Flow|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
11221783|NCT02342886|OG001|Outcome|DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
11221784|NCT02342886|OG002|Outcome|DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
11221785|NCT02342886|OG003|Outcome|DS-TB: 2 Months HRZE / 4 Months HR|Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
11221786|NCT02342886|OG004|Outcome|MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|"Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.~Note: The MDR-TB group was not randomized and not included in the analysis population."
11221787|NCT02342886|EG000|Reported Event|DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
11221788|NCT02342886|EG001|Reported Event|DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
10854321|NCT00322465|FG003|Participant Flow|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
10854322|NCT00322465|OG000|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
10854323|NCT00322465|OG001|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
10854324|NCT00322465|OG002|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
10854325|NCT00322465|OG003|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
10854326|NCT00322465|OG000|Outcome|Doxycycline + (Doxycycline + Tinidazole)|Doxycycline 100 mg PO BID (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin PO single dose and placebo tinidazole + (Doxycycline 100 mg PO BID for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm PO single dose (4 tablets at 500 mg each)).
10854327|NCT00322465|OG001|Outcome|Azithromycin + (Azithromycin + Tinidazole)|Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
11221789|NCT02342886|EG002|Reported Event|DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
11221790|NCT02342886|EG003|Reported Event|DS-TB: 2 Months HRZE/ 4 Months HR|Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
10854328|NCT00322465|OG000|Outcome|All Participants Analyzed|
10854329|NCT00322465|EG000|Reported Event|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
10854330|NCT00322465|EG001|Reported Event|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
10854331|NCT00322465|EG002|Reported Event|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
10854332|NCT00322465|EG003|Reported Event|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
10854333|NCT00322491|BG000|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854334|NCT00322491|BG001|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
11221791|NCT02342886|EG004|Reported Event|MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide|Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
11221792|NCT02343003|BG000|Baseline|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
11221793|NCT02343003|BG001|Baseline|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
11221794|NCT02343003|BG002|Baseline|Total|Total of all reporting groups
11221795|NCT02343003|FG000|Participant Flow|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
11221796|NCT02343003|FG001|Participant Flow|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
11221797|NCT02343003|OG000|Outcome|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
11221798|NCT02343003|OG001|Outcome|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
11221799|NCT02343003|EG000|Reported Event|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
11221800|NCT02343003|EG001|Reported Event|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
11221801|NCT02343081|BG000|Baseline|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
11221802|NCT02343081|BG001|Baseline|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
11221803|NCT02343081|BG002|Baseline|Total|Total of all reporting groups
11221804|NCT02343081|FG000|Participant Flow|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
11343622|NCT03900416|OG000|Outcome|Mindfulness App|"Guided mindfulness exercises will be delivered via mobile app for three weeks.~Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction."
11343623|NCT03900416|OG001|Outcome|Control Condition|Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
11343624|NCT03900416|EG000|Reported Event|Mindfulness App|"Guided mindfulness exercises will be delivered via mobile app for three weeks.~Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction."
11343625|NCT03900416|EG001|Reported Event|Control Condition|Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
11343626|NCT03905863|BG000|Baseline|Standard of Care Arm|Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre.
11343627|NCT03905863|BG001|Baseline|Intervention Arm|"Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound.~Natrox® Oxygen Wound Therapy: A battery-operated device which delivers 98% pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system."
11343628|NCT03905863|BG002|Baseline|Total|Total of all reporting groups
11343629|NCT03905863|FG000|Participant Flow|Standard of Care Arm|SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardized protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.
10845372|NCT00266825|OG001|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
10845373|NCT00266825|EG000|Reported Event|Placebo Capsule - Mother|"Placebo capsule~Placebo capsule: Placebo capsule"
11221805|NCT02343081|FG001|Participant Flow|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
11221806|NCT02343081|OG000|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
11221807|NCT02343081|OG001|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
11221808|NCT02343081|EG000|Reported Event|Temodal|Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
11221809|NCT02343081|EG001|Reported Event|Dralitem|Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose.
11221810|NCT02343276|BG000|Baseline|Placebo|"Placebo (saline solution 10 ml) in radial artery after sheath insertion~Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion"
11221811|NCT02343276|BG001|Baseline|Intervention|"Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion~Nitroglycerin: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion"
11221812|NCT02343276|BG002|Baseline|Total|Total of all reporting groups
11221813|NCT02343276|FG000|Participant Flow|Placebo|"Placebo (saline solution 10 ml) in radial artery after sheath insertion~Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion"
11221814|NCT02343276|FG001|Participant Flow|Intervention|"Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion~Nitroglycerin: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion"
11221815|NCT02343276|OG000|Outcome|Placebo|"Placebo (saline solution 10 ml) in radial artery after sheath insertion~Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion"
11221816|NCT02343276|OG001|Outcome|Intervention|"Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion~Nitroglycerin: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion"
11221817|NCT02343276|EG000|Reported Event|Placebo|"Placebo (saline solution 10 ml) in radial artery after sheath insertion~Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion"
11221818|NCT02343276|EG001|Reported Event|Intervention|"Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion~Nitroglycerin: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion"
11221819|NCT02343380|BG000|Baseline|Morning-first, Then Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221820|NCT02343380|BG001|Baseline|Evening-first, Then Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221821|NCT02343380|BG002|Baseline|Total|Total of all reporting groups
11221822|NCT02343380|FG000|Participant Flow|Morning-first, Then Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221823|NCT02343380|FG001|Participant Flow|Evening-first, Then Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221824|NCT02343380|OG000|Outcome|Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221825|NCT02343380|OG001|Outcome|Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221826|NCT02343380|OG000|Outcome|Morning|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
11221827|NCT02343380|OG001|Outcome|Evening|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm
11221828|NCT02343380|OG000|Outcome|Morning|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am.~The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221829|NCT02343380|OG001|Outcome|Evening|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm~The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221830|NCT02343380|OG000|Outcome|Morning|Variation in morning adrenalin and noradrenalin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am
11221831|NCT02343380|OG001|Outcome|Evening|Variation in evening adrenalin and noradrenalin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
11221832|NCT02343380|OG000|Outcome|Morning|Variation in morning acylated ghrelin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am
11221833|NCT02343380|OG001|Outcome|Evening|Variation in evening acylated ghrelin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm
11221834|NCT02343380|OG000|Outcome|Morning|Variation in morning glucagon-like peptide 1 Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am
11221835|NCT02343380|OG001|Outcome|Evening|Variation in morning glucagon-like peptide 1 Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
11221836|NCT02343380|EG000|Reported Event|Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221837|NCT02343380|EG001|Reported Event|Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
11221838|NCT02343406|BG000|Baseline|ABT-414/Temozolomide|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks in combination with temozolomide (TMZ) to adult participants
11221839|NCT02343406|BG001|Baseline|ABT-414_adult|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to adult participants
11221840|NCT02343406|BG002|Baseline|Control_lomustine|Adult participants relapsing during temozolomide (TMZ) treatment or within the first 16 weeks after the first day of the last TMZ cycle received lomustine on Day 1 of every 42-day treatment period until one of the treatment withdrawal criteria was met, up to a maximum of 1 year.
11221841|NCT02343406|BG003|Baseline|Control_ Temozolomide|Adult participants relapsing 16 weeks or more after the first day of the last temozolomide (TMZ) cycle received TMZ on Day 1 to Day 5 for the first 28-day cycle, with dose escalation in subsequent cycles in case of adequate tolerance and treatment continuing until one of the treatment withdrawal criteria was met.
11221842|NCT02343406|BG004|Baseline|ABT-414_ Pediatric|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to pediatric participants. Temozolomide (TMZ) was only allowed for pediatric participants if its use was in accordance with local clinical practice, and was not considered an investigational product for the study (unless this was a local requirement).
11221843|NCT02343406|BG005|Baseline|Total|Total of all reporting groups
11221844|NCT02343406|FG000|Participant Flow|ABT-414/Temozolomide|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks in combination with temozolomide (TMZ) to adult participants
11221845|NCT02343406|FG001|Participant Flow|ABT-414_adult|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to adult participants
11221846|NCT02343406|FG002|Participant Flow|Control_lomustine|Adult participants relapsing during temozolomide (TMZ) treatment or within the first 16 weeks after the first day of the last TMZ cycle received lomustine on Day 1 of every 42-day treatment period until one of the treatment withdrawal criteria was met, up to a maximum of 1 year.
11221847|NCT02343406|FG003|Participant Flow|Control_ Temozolomide|Adult participants relapsing 16 weeks or more after the first day of the last temozolomide (TMZ) cycle received TMZ on Day 1 to Day 5 for the first 28-day cycle, with dose escalation in subsequent cycles in case of adequate tolerance and treatment continuing until one of the treatment withdrawal criteria was met.
11221848|NCT02343406|FG004|Participant Flow|ABT-414_ Pediatric|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to pediatric participants. Temozolomide (TMZ) was only allowed for pediatric participants if its use was in accordance with local clinical practice, and was not considered an investigational product for the study (unless this was a local requirement).
11221849|NCT02343406|OG000|Outcome|ABT-414/Temozolomide|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks in combination with temozolomide (TMZ) to adult participants
11221850|NCT02343406|OG001|Outcome|ABT-414_adult|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to adult participants
11221851|NCT02343406|OG002|Outcome|Control (Temozolomide/Lomustine)|Adult participants relapsing during temozolomide (TMZ) treatment or within the first 16 weeks after the first day of the last TMZ cycle who received lomustine on Day 1 of every 42-day treatment period until one of the treatment withdrawal criteria was met, up to a maximum of 1 year OR adult subjects relapsing 16 weeks or more after the first day of the last temozolomide (TMZ) cycle who received TMZ on Day 1 to Day 5 for the first 28-day cycle, with dose escalation in subsequent cycles in case of adequate tolerance and treatment continuing until one of the treatment withdrawal criteria was met.
11221852|NCT02343406|OG000|Outcome|ABT-414_ Pediatric|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to pediatric participants. Temozolomide (TMZ) was only allowed for pediatric participants if its use was in accordance with local clinical practice, and was not considered an investigational product for the study (unless this was a local requirement).
11221853|NCT02343406|EG000|Reported Event|ABT-414/Temozolomide|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks in combination with temozolomide (TMZ) to adult subjects
11221854|NCT02343406|EG001|Reported Event|ABT-414_adult|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to adult subjects
11221855|NCT02343406|EG002|Reported Event|Control_lomustine|Adult subjects relapsing during temozolomide (TMZ) treatment or within the first 16 weeks after the first day of the last TMZ cycle received lomustine on Day 1 of every 42-day treatment period until one of the treatment withdrawal criteria was met, up to a maximum of 1 year.
10845374|NCT00266825|EG001|Reported Event|Placebo Capsule - Infant|Infants born from Mothers in the Placebo capsule group
10845375|NCT00266825|EG002|Reported Event|DHA Capsule - Mother|"DHA capsule~DHA: 600 mg DHA"
10845376|NCT00266825|EG003|Reported Event|DHA Capsule - Infant|Infants born from Mothers in the DHA capsule group
10845377|NCT00266851|BG000|Baseline|Placebo|"Adjunctive placebo~Placebo: Matching placebo"
10845378|NCT00266851|BG001|Baseline|Azithromycin|"Active adjunctive treatment~Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks"
10845379|NCT00266851|BG002|Baseline|Observational Cohort|Eligible participants who declined randomization were offered enrollment in an observational open-label azithromycin arm
10845380|NCT00266851|BG003|Baseline|Total|Total of all reporting groups
10854335|NCT00322491|BG002|Baseline|Total|Total of all reporting groups
10854336|NCT00322491|FG000|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854337|NCT00322491|FG001|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854338|NCT00322491|OG000|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854339|NCT00322491|OG001|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854340|NCT00322491|OG002|Outcome|All Participants|
10854341|NCT00322491|EG000|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854342|NCT00322491|EG001|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854343|NCT00322556|BG000|Baseline|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
10854344|NCT00322556|FG000|Participant Flow|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
10854345|NCT00322556|OG000|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
10854346|NCT00322556|OG000|Outcome|IgPro10 (≤ 4 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the maximum infusion rate (≤ 4 mg/kg/min) for new subjects.
10854347|NCT00322556|OG001|Outcome|IgPro10 (≤ 8 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.
10854348|NCT00322556|OG002|Outcome|IgPro10 (> 8 to ≤ 12 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (> 8 and ≤ 12 mg/kg/min) for old subjects.
10854349|NCT00322556|EG000|Reported Event|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
10854350|NCT00322621|BG000|Baseline|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
10854351|NCT00322621|FG000|Participant Flow|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months.
10854352|NCT00322621|FG001|Participant Flow|Maintenance Arm|Duloxetine: 60 milligrams once daily.
10854353|NCT00322621|FG002|Participant Flow|Rescue Arm|Duloxetine: 120 milligrams once daily.
10854354|NCT00322621|OG000|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
10854355|NCT00322621|OG000|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
10854356|NCT00322621|OG000|Outcome|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
10854357|NCT00322621|OG000|Outcome|All Maintenance / Rescue Participants|Total of the Maintenance (No Dose Increase), Maintenance (Later Dose Increase) and Rescue arms. Depending on the group the patient was in, they either received duloxetine 60 mg once daily; 60 mg once daily and then increased to 120 mg once daily; or 120 mg once daily.
10854358|NCT00322621|OG001|Outcome|Maintenance Arm (No Dose Increase)|duloxetine 60 mg once daily
10854359|NCT00322621|OG002|Outcome|Maintenance Arm (Later Dose Increase)|duloxetine 60 mg once daily and then increasing to 120 mg once daily
10854360|NCT00322621|OG003|Outcome|Rescue Arm|duloxetine 120 mg once daily
10854361|NCT00322621|OG000|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
10854362|NCT00322621|OG001|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
10854363|NCT00322621|EG000|Reported Event|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
10854364|NCT00322621|EG001|Reported Event|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
10854365|NCT00322712|BG000|Baseline|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
11221856|NCT02343406|EG003|Reported Event|Control_ Temozolomide|Adult subjects relapsing 16 weeks or more after the first day of the last temozolomide (TMZ) cycle received TMZ on Day 1 to Day 5 for the first 28-day cycle, with dose escalation in subsequent cycles in case of adequate tolerance and treatment continuing until one of the treatment withdrawal criteria was met.
10854366|NCT00322712|FG000|Participant Flow|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
10854367|NCT00322712|OG000|Outcome|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
10854368|NCT00322712|EG000|Reported Event|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
10854369|NCT00322777|BG000|Baseline|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
10854370|NCT00322777|BG001|Baseline|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
10854371|NCT00322777|BG002|Baseline|Total|Total of all reporting groups
10854372|NCT00322777|FG000|Participant Flow|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
10854373|NCT00322777|FG001|Participant Flow|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
10854374|NCT00322777|OG000|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
10854375|NCT00322777|OG001|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
10854376|NCT00322777|EG000|Reported Event|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
10854377|NCT00322777|EG001|Reported Event|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
10854378|NCT00322842|BG000|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854379|NCT00322842|BG001|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854380|NCT00322842|BG002|Baseline|Total|Total of all reporting groups
11221857|NCT02343406|EG004|Reported Event|ABT-414_ Pediatric|Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to pediatric participants. Temozolomide (TMZ) was only allowed for pediatric participants if its use was in accordance with local clinical practice, and was not considered an investigational product for the study (unless this was a local requirement).
10854381|NCT00322842|FG000|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854382|NCT00322842|FG001|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854383|NCT00322842|OG000|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854384|NCT00322842|OG001|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854385|NCT00322842|OG002|Outcome|All Participants|
11221858|NCT02343458|BG000|Baseline|GFF MDI 14.4/9.6 ug|Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug
11221859|NCT02343458|BG001|Baseline|FF MDI 9.6 ug|Formoterol Fumarate, Metered Dose Inhalation 9.6 ug
11221860|NCT02343458|BG002|Baseline|GP MDI 14.4 ug|Glycopyrronium 14.4 ug Metered Dose Inhalation
11221861|NCT02343458|BG003|Baseline|Placebo MDI|Placebo Metered Dose Inhalation
11221862|NCT02343458|BG004|Baseline|Total|Total of all reporting groups
11221863|NCT02343458|FG000|Participant Flow|GFF MDI 14.4/9.6 ug|Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug
11221864|NCT02343458|FG001|Participant Flow|FF MDI 9.6 ug|Formoterol Fumarate, Metered Dose Inhalation 9.6 ug
11221865|NCT02343458|FG002|Participant Flow|GP MDI 14.4 ug|Glycopyrronium 14.4 ug Metered Dose Inhalation
10845381|NCT00266851|FG000|Participant Flow|Placebo|"Adjunctive placebo~Placebo: Matching placebo"
10845382|NCT00266851|FG001|Participant Flow|Azithromycin|"Active adjunctive treatment~Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks"
10845383|NCT00266851|FG002|Participant Flow|Observational Cohort|Eligible participants that declined randomization were offered enrollment in open-label, azithromycin treatment arm
11221866|NCT02343458|FG003|Participant Flow|Placebo MDI|Placebo Metered Dose Inhalation
10845384|NCT00266851|OG000|Outcome|Placebo|"Adjunctive placebo~Placebo: Matching placebo"
10845385|NCT00266851|OG001|Outcome|Azithromycin|"Active adjunctive treatment~Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks"
10845386|NCT00266851|OG002|Outcome|Observational Cohort|Eligible Participants who declined randomization were offered enrollment in a parallel open-label observational treatment arm
10845387|NCT00266851|OG002|Outcome|Observational Cohort|Eligible participants who declined randomization were offered enrollment in an open-label observational treatment arm.
10845388|NCT00266851|OG000|Outcome|Placebo|Randomized placebo
10845389|NCT00266851|OG001|Outcome|Azithromycin|Randomized azithromycin
10845390|NCT00266851|OG002|Outcome|Open-Label Azithromycin|Eligible participants who declined randomization were offered enrollment in an open-label observational treatment arm.
10845391|NCT00266851|EG000|Reported Event|Placebo|"Adjunctive placebo~Placebo: Matching placebo"
10845392|NCT00266851|EG001|Reported Event|Azithromycin|"Active adjunctive treatment~Azithromycin: 600 mg x 3 days, then 600 mg weekly x 11 weeks"
10845393|NCT00266851|EG002|Reported Event|Observational Cohort|Eligible participants who refused randomization were offered enrollment in an open-label azithromycin arm
10845394|NCT00266864|BG000|Baseline|Testosterone Replacement Therapy|Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
11221867|NCT02343458|OG000|Outcome|GFF MDI 14.4/9.6 ug|Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug
11221868|NCT02343458|OG001|Outcome|FF MDI 9.6 ug|Formoterol Fumarate, Metered Dose Inhalation 9.6 ug
11221869|NCT02343458|OG002|Outcome|GP MDI 14.4 ug|Glycopyrronium 14.4 ug Metered Dose Inhalation
11221870|NCT02343458|OG003|Outcome|Placebo MDI|Placebo Metered Dose Inhalation
11221871|NCT02343458|EG000|Reported Event|GFF MDI 14.4/9.6 ug|Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug
11221872|NCT02343458|EG001|Reported Event|FF MDI 9.6 ug|Formoterol Fumarate, Metered Dose Inhalation 9.6 ug
11221873|NCT02343458|EG002|Reported Event|GP MDI 14.4 ug|Glycopyrronium 14.4 ug Metered Dose Inhalation
11221874|NCT02343458|EG003|Reported Event|Placebo MDI|Placebo Metered Dose Inhalation
10845395|NCT00266864|BG001|Baseline|No Intervention|Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
10845396|NCT00266864|BG002|Baseline|Total|Total of all reporting groups
10845397|NCT00266864|FG000|Participant Flow|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
10845398|NCT00266864|FG001|Participant Flow|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
10845399|NCT00266864|OG000|Outcome|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
10845400|NCT00266864|OG001|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
10845401|NCT00266864|OG000|Outcome|Testosterone Replacement Therapy|Testosterone Replacement Therapy Patch 5 or 10 mg daily
11221875|NCT02343575|BG000|Baseline|Valproic Acid|Participants received VPA and flexible haloperidol as needed.
11221876|NCT02343575|BG001|Baseline|Placebo|Participants received VPA placebo and flexible haloperidol as needed.
11221877|NCT02343575|BG002|Baseline|Total|Total of all reporting groups
11221878|NCT02343575|FG000|Participant Flow|Valproic Acid|Participants received Valproic Acid (VPA) and flexible haloperidol as needed.
11221879|NCT02343575|FG001|Participant Flow|Placebo|Participants received VPA placebo and flexible haloperidol as needed.
11221880|NCT02343575|OG000|Outcome|Valproic Acid|Participants received VPA and flexible haloperidol as needed.
11221881|NCT02343575|OG001|Outcome|Placebo|Participants received VPA placebo and flexible haloperidol as needed.
11221882|NCT02343575|EG000|Reported Event|Valproic Acid|Participants received VPA and flexible haloperidol as needed.
11221883|NCT02343575|EG001|Reported Event|Placebo|Participants received VPA placebo and flexible haloperidol as needed.
11221884|NCT02343627|BG000|Baseline|NVXT Solution|"NVXT Solution once daily for 60 days~NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days."
11221885|NCT02343627|BG001|Baseline|Vehicle of Test Product|"Vehicle of test product, once daily for 60 days~Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days."
11221886|NCT02343627|BG002|Baseline|Total|Total of all reporting groups
10854386|NCT00322842|EG000|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854387|NCT00322842|EG001|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10854388|NCT00322868|BG000|Baseline|Pioglitazone (30 mg)|After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally, 30 mg, once daily, for 28 days
10854389|NCT00322868|FG000|Participant Flow|Pioglitazone (30 mg)|After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally, 30 mg, once daily, for 28 days
10854390|NCT00322868|OG000|Outcome|Baseline|Results pre-Pioglitazone dosing
10854391|NCT00322868|OG001|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
11221887|NCT02343627|FG000|Participant Flow|NVXT Solution|"NVXT Solution once daily for 60 days~NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days."
11221888|NCT02343627|FG001|Participant Flow|Vehicle of Test Product|"Vehicle of test product, once daily for 60 days~Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days."
11221889|NCT02343627|OG000|Outcome|NVXT Solution|"NVXT Solution once daily for 60 days~NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days."
11221890|NCT02343627|OG001|Outcome|Vehicle of Test Product|"Vehicle of test product, once daily for 60 days~Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days."
11221891|NCT02343627|EG000|Reported Event|NVXT Solution|"NVXT Solution once daily for 60 days~NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days."
11221892|NCT02343627|EG001|Reported Event|Vehicle of Test Product|"Vehicle of test product, once daily for 60 days~Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days."
10854392|NCT00322868|EG000|Reported Event|Pioglitazone (30 mg)|After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally,30 mg, once daily for 28 days
10854393|NCT00322881|BG000|Baseline|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
10854394|NCT00322881|FG000|Participant Flow|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
10854395|NCT00322881|OG000|Outcome|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
10854396|NCT00322881|EG000|Reported Event|Carboplatin/Paclitaxel|"Paclitaxel: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)~Carboplatin: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)"
10854397|NCT00323063|BG000|Baseline|Arm I|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.~gemcitabine hydrochloride: Given IV"
10854398|NCT00323063|BG001|Baseline|Arm II|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
10854399|NCT00323063|BG002|Baseline|Total|Total of all reporting groups
10854400|NCT00323063|FG000|Participant Flow|Gemcitabine Hydrochloride|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.~gemcitabine hydrochloride: Given IV"
10854401|NCT00323063|FG001|Participant Flow|Gemcitabine Hydrochloride + Imatinib|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
10854402|NCT00323063|OG000|Outcome|Arm I (Gemcitabine Hydrochloride)|"Patients receive gemcitabine hydrochloride IV on days 3 and 10.~gemcitabine hydrochloride: Given IV"
10854403|NCT00323063|OG001|Outcome|Arm II (Gemcitabine Hydrochloride + Imatinib)|"Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
10854404|NCT00323063|EG000|Reported Event|Arm I (Gemcitabine Hydrochloride)|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.~gemcitabine hydrochloride: Given IV"
10854405|NCT00323063|EG001|Reported Event|Arm II (Gemcitabine Hydrochloride + Imatinib)|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
11221893|NCT02343939|BG000|Baseline|Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
10854406|NCT00323115|BG000|Baseline|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
10854407|NCT00323115|FG000|Participant Flow|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
10854408|NCT00323115|OG000|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
10854409|NCT00323115|OG000|Outcome|Pre-Vaccine|
10854410|NCT00323115|OG001|Outcome|Post-Vaccine|Dendritic Cell Vaccine: Vaccine given cervical lymphnode injection 3 times every other week
10854411|NCT00323115|OG000|Outcome|Vaccine - Before Starting Radiation/TMZ|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
10854412|NCT00323115|OG001|Outcome|Vaccine - First Leukapheresis|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
10854413|NCT00323115|OG002|Outcome|Vaccine - Second Leukapheresis|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
10854414|NCT00323115|EG000|Reported Event|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
10854415|NCT00323193|BG000|Baseline|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
10854416|NCT00323193|BG001|Baseline|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
10854417|NCT00323193|BG002|Baseline|Total|Total of all reporting groups
10854418|NCT00323193|FG000|Participant Flow|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
10854419|NCT00323193|FG001|Participant Flow|Control Group|The control group offers basic information about diet and exercise every month for six months.
10854420|NCT00323193|OG000|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
10854421|NCT00323193|OG001|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
10854422|NCT00323193|EG000|Reported Event|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
10854423|NCT00323193|EG001|Reported Event|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
10854424|NCT00323258|BG000|Baseline|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.~The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
10854425|NCT00323258|BG001|Baseline|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.~The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
10854426|NCT00323258|BG002|Baseline|Total|Total of all reporting groups
10854427|NCT00323258|FG000|Participant Flow|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.~The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
10854428|NCT00323258|FG001|Participant Flow|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.~The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
10854429|NCT00323258|OG000|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
10854430|NCT00323258|OG001|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
10854431|NCT00323258|EG000|Reported Event|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
10854432|NCT00323258|EG001|Reported Event|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
10854433|NCT00323271|BG000|Baseline|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
11221894|NCT02343939|BG001|Baseline|Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin|"Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).~Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles."
11221895|NCT02343939|BG002|Baseline|Group B Phase 1b ENTO 200 mg + Decitabine|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
10854434|NCT00323271|BG001|Baseline|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
10854435|NCT00323271|BG002|Baseline|Total|Total of all reporting groups
11221896|NCT02343939|BG003|Baseline|Group B Phase 1b ENTO 400 mg + Decitabine|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
10854436|NCT00323271|FG000|Participant Flow|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
10854437|NCT00323271|FG001|Participant Flow|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
10854438|NCT00323271|OG000|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
10854439|NCT00323271|OG001|Outcome|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
10854440|NCT00323271|EG000|Reported Event|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
10854441|NCT00323271|EG001|Reported Event|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
10854442|NCT00323284|BG000|Baseline|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
11221897|NCT02343939|BG004|Baseline|Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)|As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221898|NCT02343939|BG005|Baseline|Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221899|NCT02343939|BG006|Baseline|Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221900|NCT02343939|BG007|Baseline|Group C Phase 1b/2 ENTO 400 mg|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
10854443|NCT00323284|BG001|Baseline|B--Cataract Surgery Only|Cataract Surgery only
10854444|NCT00323284|BG002|Baseline|Total|Total of all reporting groups
10854445|NCT00323284|FG000|Participant Flow|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
10854446|NCT00323284|FG001|Participant Flow|B--Cataract Surgery Only|Cataract Surgery only
10854447|NCT00323284|OG000|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
10854448|NCT00323284|OG001|Outcome|B--Cataract Surgery Only|Cataract Surgery only
10854449|NCT00323284|EG000|Reported Event|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
10854450|NCT00323284|EG001|Reported Event|B--Cataract Surgery Only|Cataract Surgery only
10854451|NCT00323297|BG000|Baseline|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
10854452|NCT00323297|BG001|Baseline|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
10854453|NCT00323297|BG002|Baseline|Total|Total of all reporting groups
10854454|NCT00323297|FG000|Participant Flow|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
10854455|NCT00323297|FG001|Participant Flow|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
10854456|NCT00323297|OG000|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
10854457|NCT00323297|OG001|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
10854458|NCT00323297|EG000|Reported Event|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
10854459|NCT00323297|EG001|Reported Event|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
10854460|NCT00323310|BG000|Baseline|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
10854461|NCT00323310|FG000|Participant Flow|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
10854462|NCT00323310|OG000|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
10854463|NCT00323310|EG000|Reported Event|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
10854464|NCT00323362|BG000|Baseline|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
10854465|NCT00323362|FG000|Participant Flow|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
10854466|NCT00323362|OG000|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
10854467|NCT00323362|EG000|Reported Event|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
10854468|NCT00323414|BG000|Baseline|PUFA|Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks
10854469|NCT00323414|BG001|Baseline|Placebo|Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
10854470|NCT00323414|BG002|Baseline|Total|Total of all reporting groups
10854471|NCT00323414|FG000|Participant Flow|PUFA|Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks
10854472|NCT00323414|FG001|Participant Flow|Placebo|Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
10854473|NCT00323414|OG000|Outcome|PUFA|Active treatment with PUFA
10854474|NCT00323414|OG001|Outcome|Placebo|Placebo arm of therapy
10854475|NCT00323414|EG000|Reported Event|PUFA|Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks
10854476|NCT00323414|EG001|Reported Event|Placebo|Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
11221901|NCT02343939|BG008|Baseline|Group C Phase 1b ENTO 800 mg|Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221902|NCT02343939|BG009|Baseline|Total|Total of all reporting groups
11221903|NCT02343939|FG000|Participant Flow|Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
10854477|NCT00323427|BG000|Baseline|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
10854478|NCT00323427|BG001|Baseline|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
10854479|NCT00323427|BG002|Baseline|Total|Total of all reporting groups
10854480|NCT00323427|FG000|Participant Flow|Group Aural Rehabilitation|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
10854481|NCT00323427|FG001|Participant Flow|Hearing Aids|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
10854482|NCT00323427|OG000|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
10854483|NCT00323427|OG001|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
10854484|NCT00323427|EG000|Reported Event|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
10854485|NCT00323427|EG001|Reported Event|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
10854486|NCT00323453|BG000|Baseline|Experimental Arm|"The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.~Open appendectomy using Alexis Wound Retractor followed by standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure."
10854487|NCT00323453|BG001|Baseline|Control Arm|"Open appendectomy and standardized wound closure~Open appendectomy with standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure."
11221904|NCT02343939|FG001|Participant Flow|Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin|"Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).~Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles."
11221905|NCT02343939|FG002|Participant Flow|Group B Phase 1b ENTO 200 mg + Decitabine|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
11221906|NCT02343939|FG003|Participant Flow|Group B Phase 1b ENTO 400 mg + Decitabine|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221907|NCT02343939|FG004|Participant Flow|Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)|As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221908|NCT02343939|FG005|Participant Flow|Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
10854488|NCT00323453|BG002|Baseline|Total|Total of all reporting groups
10854489|NCT00323453|FG000|Participant Flow|Experimental Arm|"The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.~Open appendectomy using Alexis Wound Retractor followed by standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure."
10854490|NCT00323453|FG001|Participant Flow|Control Arm|"Open appendectomy and standardized wound closure~Open appendectomy with standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure."
10854491|NCT00323453|OG000|Outcome|Experimental Arm|"The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.~Open appendectomy using Alexis Wound Retractor followed by standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure."
10878874|NCT00454636|EG000|Reported Event|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
10854492|NCT00323453|OG001|Outcome|Control Arm|"Open appendectomy and standardized wound closure~Open appendectomy with standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure."
10854493|NCT00323453|EG000|Reported Event|Experimental Arm|"The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.~Open appendectomy using Alexis Wound Retractor followed by standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure."
10854494|NCT00323453|EG001|Reported Event|Control Arm|"Open appendectomy and standardized wound closure~Open appendectomy with standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure."
10854495|NCT00323479|BG000|Baseline|Anastrozole 1 mg|Anastrozole 1 mg once daily
10854496|NCT00323479|FG000|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg once daily
10854497|NCT00323479|OG000|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
10854498|NCT00323479|EG000|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg once daily
10854499|NCT00323492|BG000|Baseline|Truvada|Truvada + NNRTI or PI.
10854500|NCT00323492|BG001|Baseline|Maintain Baseline Regimen|Maintain baseline regimen.
10854501|NCT00323492|BG002|Baseline|Total|Total of all reporting groups
10854502|NCT00323492|FG000|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
10854503|NCT00323492|FG001|Participant Flow|Maintain Baseline Regimen|Maintain baseline regimen.
10854504|NCT00323492|FG002|Participant Flow|Delayed Truvada|Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).
11221909|NCT02343939|FG006|Participant Flow|Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221910|NCT02343939|FG007|Participant Flow|Group C Phase 1b/2 ENTO 400 mg|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221911|NCT02343939|FG008|Participant Flow|Group C Phase 1b ENTO 800 mg|Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
10854505|NCT00323492|OG000|Outcome|Truvada|Truvada + NNRTI or PI.
10854506|NCT00323492|OG001|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
10854507|NCT00323492|EG000|Reported Event|Truvada|Truvada + NNRTI or PI. The number of participants at risk is the number who started the study by switching to Truvada. Participants in this group were to remain on Truvada for 48 weeks (duration of the study). The number at risk was reduced only by study discontinuation (from 47 at baseline to 40 who completed Study Phase 2).
10854508|NCT00323492|EG001|Reported Event|Maintain Baseline Regimen|Maintain baseline regimen. The number of participants at risk is the number who started the study by maintaining their baseline regimen. Per protocol, participants in this group were allowed to switch to Truvada after Week 12 (Delayed TVD group), therefore the number of participants at risk declines over time (from 45 at baseline to 17 who completed Study Phase 2; with most participants switching to Truvada at Week 12).
10854509|NCT00323492|EG002|Reported Event|All Truvada|"Truvada + NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups). The number of participants at risk is the number who started the study by switching to Truvada (Truvada group), plus those who started the study by maintaining their baseline regimen but who switched to Truvada during the study (Delayed Truvada group). The number of participants at risk increases over time (from 47 at baseline to 72 when the last switch to Truvada took place; 25 participants switched to Truvada from the maintain baseline regimen group in Study Phase 2)."
10854510|NCT00323557|BG000|Baseline|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
10854511|NCT00323557|BG001|Baseline|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
10854512|NCT00323557|BG002|Baseline|Total|Total of all reporting groups
10854513|NCT00323557|FG000|Participant Flow|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
10854514|NCT00323557|FG001|Participant Flow|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
10854515|NCT00323557|OG000|Outcome|Pneumococcal Vaccine + Pre Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given pre vaccination Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).
10854516|NCT00323557|OG001|Outcome|Pneumococcal Vaccine + Post Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given Day 0 (day of pneumococcal vaccine), and post vaccination at Day +3 and Day +7.
10854517|NCT00323557|OG002|Outcome|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0. No CM-CSF.
10854518|NCT00323557|EG000|Reported Event|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
10854519|NCT00323557|EG001|Reported Event|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
10854520|NCT00323609|BG000|Baseline|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
10854521|NCT00323609|BG001|Baseline|Vertebroplasty|This group of patients has received vertebroplasty procedure.
10854522|NCT00323609|BG002|Baseline|Total|Total of all reporting groups
10854523|NCT00323609|FG000|Participant Flow|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
10854524|NCT00323609|FG001|Participant Flow|Vertebroplasty|This group of patients has received vertebroplasty procedure.
10854525|NCT00323609|FG002|Participant Flow|Kyphoplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
10854526|NCT00323609|FG003|Participant Flow|Vertebroplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
10854527|NCT00323609|OG000|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
10854528|NCT00323609|OG001|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
10854529|NCT00323609|EG000|Reported Event|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
10854530|NCT00323609|EG001|Reported Event|Vertebroplasty|This group of patients has received vertebroplasty procedure.
10854531|NCT00323622|BG000|Baseline|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854532|NCT00323622|BG001|Baseline|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854533|NCT00323622|BG002|Baseline|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854534|NCT00323622|BG003|Baseline|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854535|NCT00323622|BG004|Baseline|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854536|NCT00323622|BG005|Baseline|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854537|NCT00323622|BG006|Baseline|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854538|NCT00323622|BG007|Baseline|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854539|NCT00323622|BG008|Baseline|Total|Total of all reporting groups
10854540|NCT00323622|FG000|Participant Flow|Cohort 1-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection
10854541|NCT00323622|FG001|Participant Flow|Cohort 1-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854542|NCT00323622|FG002|Participant Flow|Cohort 2-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854543|NCT00323622|FG003|Participant Flow|Cohort 2-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854544|NCT00323622|FG004|Participant Flow|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854545|NCT00323622|FG005|Participant Flow|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854546|NCT00323622|FG006|Participant Flow|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854547|NCT00323622|FG007|Participant Flow|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study
10854548|NCT00323622|OG000|Outcome|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854549|NCT00323622|OG001|Outcome|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854550|NCT00323622|OG002|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854551|NCT00323622|OG003|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854552|NCT00323622|OG004|Outcome|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10878875|NCT00454636|EG001|Reported Event|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
10854553|NCT00323622|OG005|Outcome|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854554|NCT00323622|OG006|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
11221912|NCT02343939|OG000|Outcome|Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
11221913|NCT02343939|OG001|Outcome|Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin|"Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).~Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles."
11221914|NCT02343939|OG002|Outcome|Group B Phase 1b ENTO 200 mg + Decitabine|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
11348494|NCT04157738|BG000|Baseline|Fixed Group|"Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.~Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)~Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)"
10854555|NCT00323622|OG007|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854556|NCT00323622|OG000|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
10854557|NCT00323622|OG001|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
10854558|NCT00323622|OG002|Outcome|Cohort 2-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-RTS,S/AS02A <24M and Cohort 2-RTS,S/AS02A ≥24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10878876|NCT00454636|EG002|Reported Event|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
10854559|NCT00323622|OG003|Outcome|Cohort 2-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-Engerix-B ≥24M and Cohort 2-Prevnar-Hiberix <24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854560|NCT00323622|OG000|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
11221915|NCT02343939|OG003|Outcome|Group B Phase 1b ENTO 400 mg + Decitabine|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221916|NCT02343939|OG004|Outcome|Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)|As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221917|NCT02343939|OG005|Outcome|Group C Phase 1b/2 ENTO 400 mg|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221918|NCT02343939|OG006|Outcome|Group C Phase 1b ENTO 800 mg|Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221919|NCT02343939|OG001|Outcome|Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
11221920|NCT02343939|OG002|Outcome|Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy). Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
11221921|NCT02343939|OG003|Outcome|Group B Phase 1b ENTO 200 mg + Decitabine|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
11221922|NCT02343939|OG004|Outcome|Group B Phase 1b ENTO 400 mg + Decitabine|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
10878877|NCT00454636|EG003|Reported Event|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
10854561|NCT00323622|OG001|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854562|NCT00323622|OG002|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854563|NCT00323622|OG003|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854564|NCT00323622|EG000|Reported Event|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854565|NCT00323622|EG001|Reported Event|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854566|NCT00323622|EG002|Reported Event|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854567|NCT00323622|EG003|Reported Event|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854568|NCT00323622|EG004|Reported Event|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854569|NCT00323622|EG005|Reported Event|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
10854570|NCT00323622|EG006|Reported Event|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854571|NCT00323622|EG007|Reported Event|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
10854572|NCT00323739|BG000|Baseline|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
10854573|NCT00323739|FG000|Participant Flow|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
10854574|NCT00323739|OG000|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
10854575|NCT00323739|EG000|Reported Event|Bevacizumab + Everolimus|
10854576|NCT00323869|BG000|Baseline|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
10854577|NCT00323869|FG000|Participant Flow|Bevacizumab + Carboplatin + Gemcitabine|"Bevacizumab in combination with carboplatin and gemcitabine~Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity Gemcitabine, administered 1000 mg/m2 IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles~Carboplatin was administered before gemcitabine infusion.~Bevacizumab was administered 1 hour after end of all chemotherapy infusions.~Bevacizumab: Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody~Gemcitabine: Nucleoside analog~Carboplatin: Alkylating agent"
10854578|NCT00323869|OG000|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
11221923|NCT02343939|OG005|Outcome|Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)|As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221924|NCT02343939|OG006|Outcome|Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221925|NCT02343939|OG007|Outcome|Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221926|NCT02343939|OG008|Outcome|Group C Phase 1b ENTO 400 mg|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221927|NCT02343939|OG009|Outcome|Group C Phase 1b ENTO 800 mg|Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221928|NCT02343939|OG010|Outcome|Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)|Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221929|NCT02343939|OG011|Outcome|Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)|Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221930|NCT02343939|OG012|Outcome|Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)|Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11336362|NCT03565315|OG004|Outcome|Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (*Only 1 Dose)|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11221931|NCT02343939|OG005|Outcome|Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221932|NCT02343939|OG006|Outcome|Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221933|NCT02343939|OG007|Outcome|Group C Phase 1b/2 ENTO 400 mg|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221934|NCT02343939|OG008|Outcome|Group C Phase 1b ENTO 800 mg|Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
11221935|NCT02343939|EG000|Reported Event|Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
11221936|NCT02343939|EG001|Reported Event|Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin|"Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).~Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles."
11221937|NCT02343939|EG002|Reported Event|Group B Phase 1b ENTO 200 mg + Decitabine|Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
11221938|NCT02343939|EG003|Reported Event|Group B Phase 1b ENTO 400 mg + Decitabine|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221939|NCT02343939|EG004|Reported Event|Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)|As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221940|NCT02343939|EG005|Reported Event|Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
10854579|NCT00323869|EG000|Reported Event|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
11221941|NCT02343939|EG006|Reported Event|Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)|Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11221942|NCT02343939|EG007|Reported Event|Group C Phase 1b/2 ENTO 400 mg|Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
10854580|NCT00323882|BG000|Baseline|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854581|NCT00323882|BG001|Baseline|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854582|NCT00323882|BG002|Baseline|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854583|NCT00323882|BG003|Baseline|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854584|NCT00323882|BG004|Baseline|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854585|NCT00323882|BG005|Baseline|Total|Total of all reporting groups
10854586|NCT00323882|FG000|Participant Flow|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of the induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854587|NCT00323882|FG001|Participant Flow|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses (maintenance). The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854588|NCT00323882|FG002|Participant Flow|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10879560|NCT00458484|BG004|Baseline|Series 2/Dose Level 1: Stereotactic Radiosurgery|"Series II: Radiation will be delivered in 3 fractions: 16 Gy x 3 fractions total dose of 48 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
11221943|NCT02343939|EG008|Reported Event|Group C Phase 1b ENTO 800 mg|Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
10854589|NCT00323882|FG003|Participant Flow|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to Response Evaluation Criteria in Solid Tumors (RECIST), target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854590|NCT00323882|FG004|Participant Flow|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854591|NCT00323882|OG000|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854592|NCT00323882|OG001|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854593|NCT00323882|OG002|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854594|NCT00323882|OG003|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854595|NCT00323882|OG004|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854596|NCT00323882|OG000|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854597|NCT00323882|OG004|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10879568|NCT00458484|FG004|Participant Flow|Series 2/Dose Level 1: Stereotactic Radiosurgery|"Dose Level I: Radiation will be delivered in 3 fractions:~16 Gy X 3 fractions: Total of 48 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
11221944|NCT02344004|BG000|Baseline|LAI + Multi-drug Regimen|Participants received LAI 590 mg QD in addition to their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines); LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes
11221945|NCT02344004|BG001|Baseline|Multi-drug Regimen|Participants received their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines)
11221946|NCT02344004|BG002|Baseline|Total|Total of all reporting groups
10854598|NCT00323882|OG005|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854599|NCT00323882|OG000|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854600|NCT00323882|OG001|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854601|NCT00323882|OG002|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants who had received no chemotherapy prior to the study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854602|NCT00323882|OG002|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants with no prior chemotherapy, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854603|NCT00323882|OG005|Outcome|All Treated Participants|All participants in all treatment arms combined.
10854604|NCT00323882|OG005|Outcome|All Treated Participants|All treatment groups are combined to show total overall survival at completion of Follow Up.
10854605|NCT00323882|EG000|Reported Event|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854606|NCT00323882|EG001|Reported Event|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
11221947|NCT02344004|FG000|Participant Flow|LAI + Multi-drug Regimen|Participants received Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in addition to their already prescribed anti-mycobacterial regimen (based on the 2007 American Thoracic Society/Infectious Diseases Society of America [ATS/IDSA] Guidelines); LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes
11221948|NCT02344004|FG001|Participant Flow|Multi-drug Regimen|Participants received their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines)
11336363|NCT03565315|OG005|Outcome|Overall 10E8VLS+VRC07-523LS Groups|Total number of participants who received an SC injection of 10E8VLS and an SC injection of VRC07-523LS concurrently - Groups 3 and 4 received 10E8VLS and VRC07-523LS
10854607|NCT00323882|EG002|Reported Event|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854608|NCT00323882|EG003|Reported Event|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854609|NCT00323882|EG004|Reported Event|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
10854610|NCT00323960|BG000|Baseline|MPDN+PDN|"MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent~3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years."
11221949|NCT02344004|OG000|Outcome|LAI + Multi-drug Regimen|Participants received LAI 590 mg once daily (QD) in addition to their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines); LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes
11221950|NCT02344004|OG001|Outcome|Multi-drug Regimen|Participants received their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines)
11221951|NCT02344004|OG000|Outcome|LAI + Multi-drug Regimen|Participants received LAI 590 mg QD in addition to their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines); LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes
11221952|NCT02344004|EG000|Reported Event|LAI + Multi-drug Regimen|Participants received LAI 590 mg QD in addition to their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines); LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes
11221953|NCT02344004|EG001|Reported Event|Multi-drug Regimen|Participants received their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines)
10854611|NCT00323960|BG001|Baseline|MPDN+PDN+CSA|"MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A~3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses"
11221954|NCT02344173|BG000|Baseline|All Enrolled Subjects|Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent.
11221955|NCT02344173|FG000|Participant Flow|All Enrolled Subjects|Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent.
11221956|NCT02344173|OG000|Outcome|Per-Protocol|Patients that were enrolled, received RF ablation therapy, and completed 12-month follow-up
11221957|NCT02344173|OG000|Outcome|Treated Subjects|Patients that were enrolled and received RF ablation therapy.
11221958|NCT02344173|OG000|Outcome|All Enrolled Subjects|Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent.
11221959|NCT02344173|EG000|Reported Event|All Enrolled Subjects|Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent.
11221960|NCT02344225|BG000|Baseline|Caffeine+Saline IV+Saline Drops|"Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention~Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)"
11221961|NCT02344225|BG001|Baseline|Caffeine+Ibp IV+Saline Drops|"Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention~Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days"
11221962|NCT02344225|BG002|Baseline|Caffeine+Saline+Ketorolac Drops|"Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention~Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days"
11221963|NCT02344225|BG003|Baseline|Total|Total of all reporting groups
10854612|NCT00323960|BG002|Baseline|MPDN+PDN+MTX|"MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate~3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision."
10854613|NCT00323960|BG003|Baseline|Total|Total of all reporting groups
10854614|NCT00323960|FG000|Participant Flow|Methylprednisolone Pulse+Prednisone|Group 1 received 3 pulses of methylprednisolone and has been randomized to prednisone or equivalent
10854615|NCT00323960|FG001|Participant Flow|Methylprednisolone Pulse+Prednisone+Cyclosporine A|Group 2 received 3 pulses of methylprednisolone and has been randomized to prednisone or equivalent plus cyclosporine A
10854616|NCT00323960|FG002|Participant Flow|Methylprednisolone Pulses+Prednisone+Methotrexate|Group 3 received 3 pulses of methylprednisolone and has been randomized to prednisone or equivalent plus methotrexate
10854617|NCT00323960|OG000|Outcome|Group 1 (MPDN+PDN)|"MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent~3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years."
10854618|NCT00323960|OG001|Outcome|Group 2 (MPDN+PDN+CSA)|"MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A~3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses"
11221964|NCT02344225|FG000|Participant Flow|Caffeine+Saline IV+Saline Drops|"Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention~Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)"
11221965|NCT02344225|FG001|Participant Flow|Caffeine+Ibp IV+Saline Drops|"Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention~Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days"
11221966|NCT02344225|FG002|Participant Flow|Caffeine+Saline+Ketorolac Drops|"Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention~Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days"
11221967|NCT02344225|OG000|Outcome|Caffeine+Saline IV+Saline Drops|"Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention~Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)"
10854619|NCT00323960|OG002|Outcome|Group 3 (MPDN+PDN+MTX)|"MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate~3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision."
10854620|NCT00323960|OG000|Outcome|Group 1 (MPDN+PDN)|"MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent~3 MPDN pulse + PDN: 3 methylprednisolone pulses (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years."
10854621|NCT00323960|OG001|Outcome|Group 2 (MPDN+PDN+CSA)|"MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A~3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses"
10854622|NCT00323960|OG002|Outcome|Group 3 (MPDN+PDN+MTX)|"MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate~3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision."
10854623|NCT00323960|EG000|Reported Event|MPDN+PDN|"MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent~3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years."
10854624|NCT00323960|EG001|Reported Event|MPDN+PDN+CSA|"MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A~3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses"
10854625|NCT00323960|EG002|Reported Event|MPDN+PDN+MTX|"MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate~3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision."
10854626|NCT00324038|BG000|Baseline|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
11221968|NCT02344225|OG001|Outcome|Caffeine+Ibp IV+Saline Drops|"Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention~Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days"
11221969|NCT02344225|OG002|Outcome|Caffeine+Saline+Ketorolac Drops|"Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention~Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days"
11221970|NCT02344225|EG000|Reported Event|Caffeine+Saline IV+Saline Drops|"Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention~Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)"
11221971|NCT02344225|EG001|Reported Event|Caffeine+Ibp IV+Saline Drops|"Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention~Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days"
11221972|NCT02344225|EG002|Reported Event|Caffeine+Saline+Ketorolac Drops|"Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention~Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days"
11221973|NCT02344238|BG000|Baseline|Standard Capsules|"Compliance measured by self-report and riboflavin measurement.~Riboflavin: 50mg"
11221974|NCT02344238|BG001|Baseline|ID Capsules Without Prompts|"Compliance measured by self-report, riboflavin measurement, and data collected by the ID Cap.~ID Cap: Capsule-encased computer chip~Riboflavin: 50mg"
11221975|NCT02344238|BG002|Baseline|ID Capsules With Prompts|"Compliance measured by self-report, riboflavin measurement, and data collected by the ID Cap. This arm will also receive prompts (reminder calls and/or text messages) to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.~ID Cap: Capsule-encased computer chip~Riboflavin: 50mg~Prompts: Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time."
11221976|NCT02344238|BG003|Baseline|Total|Total of all reporting groups
11221977|NCT02344238|FG000|Participant Flow|Standard Capsules|"Compliance measured by self-report and riboflavin measurement.~Riboflavin: 50mg"
11221978|NCT02344238|FG001|Participant Flow|ID Capsules Without Prompts|"Compliance measured by self-report, riboflavin measurement, and data collected by the ID Cap.~ID Cap: Capsule-encased computer chip~Riboflavin: 50mg"
11221979|NCT02344238|FG002|Participant Flow|ID Capsules With Prompts|"Compliance measured by self-report, riboflavin measurement, and data collected by the ID Cap. This arm will also receive prompts (reminder calls and/or text messages) to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.~ID Cap: Capsule-encased computer chip~Riboflavin: 50mg~Prompts: Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time."
11221980|NCT02344238|OG000|Outcome|Standard Capsules|"Received standard capsules, with adherence measured by self-report, pill count and riboflavin measurement.~Riboflavin: 50mg"
11221981|NCT02344238|OG001|Outcome|ID Capsules Without Prompts|"Received ID capsules, with adherence measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap.~ID Cap: Capsule containing ingestible sensor~Riboflavin: 50mg"
11221982|NCT02344238|OG002|Outcome|ID Capsules With Prompts|"Received ID capsules, with adherence measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap. This arm will also receive prompts (reminder calls and/or text messages) to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.~ID Cap: Capsule containing ingestible sensor~Riboflavin: 50mg~Prompts: Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time."
11221983|NCT02344238|OG000|Outcome|Standard Capsules|Received standard capsules (no ID cap technology).
11221984|NCT02344238|OG001|Outcome|ID Capsules|Received ID capsules: capsules containing ingestible sensor
11221985|NCT02344238|EG000|Reported Event|Standard Capsules|"Compliance measured by self-report, pill count and riboflavin measurement (study Arm 1)~Riboflavin: 50mg"
11221986|NCT02344238|EG001|Reported Event|ID Capsules|"Compliance measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap (study Arms 2 and 3).~ID Cap: Capsule-encased computer chip~Riboflavin: 50mg"
11221987|NCT02344251|BG000|Baseline|MEMS Track Cap|"Compliance measured by MEMS Cap~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed"
11221988|NCT02344251|BG001|Baseline|ID Cap Tag|"Compliance measured by ID-Cap technology~ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract."
11221989|NCT02344251|BG002|Baseline|Total|Total of all reporting groups
11221990|NCT02344251|FG000|Participant Flow|MEMS Track Cap|"Compliance measured by MEMS Cap, riboflavin and self-report.~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed~Riboflavin: 50 mg"
10854627|NCT00324038|BG001|Baseline|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
10854628|NCT00324038|BG002|Baseline|Total|Total of all reporting groups
10854629|NCT00324038|FG000|Participant Flow|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
10854630|NCT00324038|FG001|Participant Flow|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
10854631|NCT00324038|OG000|Outcome|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
10854632|NCT00324038|OG001|Outcome|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
10854633|NCT00324038|EG000|Reported Event|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
10854634|NCT00324038|EG001|Reported Event|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
10854635|NCT00324116|BG000|Baseline|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
10854636|NCT00324116|FG000|Participant Flow|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
10854637|NCT00324116|OG000|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
10854638|NCT00324116|EG000|Reported Event|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
10854639|NCT00324155|BG000|Baseline|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
10854640|NCT00324155|BG001|Baseline|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
10854641|NCT00324155|BG002|Baseline|Total|Total of all reporting groups
10854642|NCT00324155|FG000|Participant Flow|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
10854643|NCT00324155|FG001|Participant Flow|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
10854644|NCT00324155|OG000|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
10854645|NCT00324155|OG001|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
10854646|NCT00324155|OG000|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
10854647|NCT00324155|OG001|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
10854648|NCT00324155|OG000|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
10854649|NCT00324155|OG001|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
10854650|NCT00324155|OG000|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1e dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
11221991|NCT02344251|FG001|Participant Flow|ID Cap Tag|"Compliance measured by riboflavin, self-report, and ID-Cap technology.~ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.~Riboflavin: 50 mg"
11221992|NCT02344251|OG000|Outcome|MEMS Track Cap|"Adherence measured by MEMS Cap~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed"
11221993|NCT02344251|OG001|Outcome|ID Cap|"Adherence measured by ID-Cap technology.~ID-Capsule: ID-Capsule is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract."
11221994|NCT02344251|OG000|Outcome|MEMS Track Cap|"Compliance measured by MEMS Cap~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed"
11221995|NCT02344251|OG001|Outcome|ID Cap|"Compliance measured by ID-Cap technology.~ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract."
11221996|NCT02344251|EG000|Reported Event|MEMS Track Cap|"Compliance measured by MEMS Cap~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed"
11221997|NCT02344251|EG001|Reported Event|ID Cap Tag|"Compliance measured by ID-Cap technology.~ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract."
11221998|NCT02344316|BG000|Baseline|Melatonin|"Group randomized to melatonin 3 mg orally nightly~Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier"
11221999|NCT02344316|BG001|Baseline|Placebo|"Group randomized to placebo orally nightly~Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier"
11222000|NCT02344316|BG002|Baseline|Total|Total of all reporting groups
11222001|NCT02344316|FG000|Participant Flow|Melatonin|"Group randomized to melatonin 3 mg orally nightly~Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier"
11222002|NCT02344316|FG001|Participant Flow|Placebo|"Group randomized to placebo orally nightly~Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier"
11222003|NCT02344316|OG000|Outcome|Melatonin|"Group randomized to melatonin 3 mg orally nightly~Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier"
11222004|NCT02344316|OG001|Outcome|Placebo|"Group randomized to placebo orally nightly~Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier"
11222005|NCT02344316|OG000|Outcome|All Participants|All Participants
11222006|NCT02344316|OG000|Outcome|Melatonin|Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier
11222007|NCT02344316|OG001|Outcome|Placebo|Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
11222008|NCT02344316|EG000|Reported Event|Melatonin|
11222009|NCT02344316|EG001|Reported Event|Placebo|
11222010|NCT02344342|BG000|Baseline|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
11222011|NCT02344342|BG001|Baseline|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
11222012|NCT02344342|BG002|Baseline|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
10975798|NCT00937521|EG006|Reported Event|MenC (Group VII)|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
11222013|NCT02344342|BG003|Baseline|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
11222014|NCT02344342|BG004|Baseline|Total|Total of all reporting groups
11222015|NCT02344342|FG000|Participant Flow|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
11222016|NCT02344342|FG001|Participant Flow|Health Buddy Yes and Flexible Diuretic Regimen No|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
11222017|NCT02344342|FG002|Participant Flow|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
11222018|NCT02344342|FG003|Participant Flow|Health Buddy No and Flexible Diuretic No|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
11222019|NCT02344342|OG000|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
11222020|NCT02344342|OG001|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
11222021|NCT02344342|OG002|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
11222022|NCT02344342|OG003|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
11222023|NCT02344342|OG000|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
11222024|NCT02344342|OG001|Outcome|Health Buddy Yes and Flexible Diuretic Regimen No|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
11222025|NCT02344342|OG002|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
11222026|NCT02344342|OG003|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
11222027|NCT02344342|EG000|Reported Event|Health Buddy Web YES/Flexible Diuretic YES|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
10854651|NCT00324155|OG001|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
10854652|NCT00324155|OG000|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression, (PD) unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
10854653|NCT00324155|OG001|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
10854654|NCT00324155|OG000|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In maintenance phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
10854655|NCT00324155|OG001|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
10854656|NCT00324155|OG001|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
10854657|NCT00324155|OG001|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
10854658|NCT00324155|OG000|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10m g/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
11222028|NCT02344342|EG001|Reported Event|Health Buddy Web YES /Flexible Diuretic NO|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
10854659|NCT00324155|EG000|Reported Event|10 mg/kg Ipilimumab + Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 wks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
10854660|NCT00324155|EG001|Reported Event|Placebo + Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
10854661|NCT00324168|BG000|Baseline|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
10854662|NCT00324168|BG001|Baseline|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
10854663|NCT00324168|BG002|Baseline|Total|Total of all reporting groups
10854664|NCT00324168|FG000|Participant Flow|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
10854665|NCT00324168|FG001|Participant Flow|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
11222029|NCT02344342|EG002|Reported Event|Health Buddy Web NO/Flexible Diuretic YES|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
10854666|NCT00324168|OG000|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
10854667|NCT00324168|OG001|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
10854668|NCT00324168|EG000|Reported Event|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
10854669|NCT00324168|EG001|Reported Event|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
10854670|NCT00324233|BG000|Baseline|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
10854671|NCT00324233|BG001|Baseline|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
10854672|NCT00324233|BG002|Baseline|Total|Total of all reporting groups
10854673|NCT00324233|FG000|Participant Flow|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
10854674|NCT00324233|FG001|Participant Flow|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
10854675|NCT00324233|OG000|Outcome|SpeediCath|
10854676|NCT00324233|OG001|Outcome|SpediCath Compact Male|
10854677|NCT00324233|EG000|Reported Event|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
10854678|NCT00324233|EG001|Reported Event|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
10854679|NCT00324259|BG000|Baseline|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
10854680|NCT00324259|BG001|Baseline|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
10854681|NCT00324259|BG002|Baseline|Total|Total of all reporting groups
10854682|NCT00324259|FG000|Participant Flow|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
10854683|NCT00324259|FG001|Participant Flow|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
10854684|NCT00324259|OG000|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
10854685|NCT00324259|OG001|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
10854686|NCT00324259|OG000|Outcome|Arm 1 (6 mg Estradiol) and Arm 2 (30 mg Estradiol)|"Arm 1 = 6 mg of estradiol daily (2 mg tid).~Arm 2 = 30 mg of estradiol. (10 mg tid)"
10854687|NCT00324259|EG000|Reported Event|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
10854688|NCT00324259|EG001|Reported Event|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
10854689|NCT00324272|BG000|Baseline|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet's node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854690|NCT00324272|BG001|Baseline|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet's node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854691|NCT00324272|BG002|Baseline|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854692|NCT00324272|BG003|Baseline|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854693|NCT00324272|BG004|Baseline|Total|Total of all reporting groups
10854694|NCT00324272|FG000|Participant Flow|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet's node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
11222030|NCT02344342|EG003|Reported Event|Health Buddy Web NO /Flexible Diuretic NO|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
11222031|NCT02344407|BG000|Baseline|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
11222032|NCT02344407|BG001|Baseline|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
11222033|NCT02344407|BG002|Baseline|Placebo (Saline)|Placebo
11222034|NCT02344407|BG003|Baseline|Total|Total of all reporting groups
11222035|NCT02344407|FG000|Participant Flow|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
11222036|NCT02344407|FG001|Participant Flow|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
11222037|NCT02344407|FG002|Participant Flow|Placebo (Saline)|Placebo
11222038|NCT02344407|OG000|Outcome|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
11222039|NCT02344407|OG001|Outcome|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
11222040|NCT02344407|OG002|Outcome|Placebo (Saline)|Placebo
11222041|NCT02344407|EG000|Reported Event|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
11222042|NCT02344407|EG001|Reported Event|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
11222043|NCT02344407|EG002|Reported Event|Placebo (Saline)|Placebo
10854695|NCT00324272|FG001|Participant Flow|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet's node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854696|NCT00324272|FG002|Participant Flow|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854697|NCT00324272|FG003|Participant Flow|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854698|NCT00324272|OG000|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet's node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10879569|NCT00458484|FG005|Participant Flow|Series 2/Dose Level 2: Stereotactic Radiosurgery|"Dose Level 2: Radiation will be delivered in 3 fractions:~18 Gy x 3 fractions: Total of 54 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
11222044|NCT02344576|BG000|Baseline|Patient Control|Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
11222045|NCT02344576|BG001|Baseline|Patient Intervention|Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
10854699|NCT00324272|OG001|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet's node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854700|NCT00324272|OG002|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854701|NCT00324272|OG003|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854702|NCT00324272|EG000|Reported Event|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet's node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854703|NCT00324272|EG001|Reported Event|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet's node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854704|NCT00324272|EG002|Reported Event|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854705|NCT00324272|EG003|Reported Event|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
10854706|NCT00324350|BG000|Baseline|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
10854707|NCT00324350|BG001|Baseline|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
10854708|NCT00324350|BG002|Baseline|Total|Total of all reporting groups
10854709|NCT00324350|FG000|Participant Flow|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
10854710|NCT00324350|FG001|Participant Flow|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
10854711|NCT00324350|OG000|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
11222046|NCT02344576|BG002|Baseline|Caregiver Control|Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
10854712|NCT00324350|OG001|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
10854713|NCT00324350|OG000|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%) in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
11222047|NCT02344576|BG003|Baseline|Caregiver Intervention|Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
11222048|NCT02344576|BG004|Baseline|Total|Total of all reporting groups
10854714|NCT00324350|EG000|Reported Event|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
10854715|NCT00324350|EG001|Reported Event|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
10854716|NCT00324415|BG000|Baseline|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
10854717|NCT00324415|FG000|Participant Flow|Combined Modality Therapy|Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab
10854718|NCT00324415|OG000|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
10854719|NCT00324415|OG000|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
10854720|NCT00324415|EG000|Reported Event|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
10854721|NCT00324649|BG000|Baseline|Truvada|Truvada + NNRTI or PI.
10854722|NCT00324649|BG001|Baseline|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
10854723|NCT00324649|BG002|Baseline|Total|Total of all reporting groups
10854724|NCT00324649|FG000|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
10854725|NCT00324649|FG001|Participant Flow|Zidovudine/Lamivudine|Zidovudine/lamivudine + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
10854726|NCT00324649|OG000|Outcome|Truvada|Truvada + NNRTI or PI.
10854727|NCT00324649|OG001|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
10854728|NCT00324649|EG000|Reported Event|Truvada|Truvada + NNRTI or PI.
10854729|NCT00324649|EG001|Reported Event|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
10854730|NCT00324675|BG000|Baseline|Rosiglitazone|
10854731|NCT00324675|BG001|Baseline|Placebo|
10854732|NCT00324675|BG002|Baseline|Total|Total of all reporting groups
10854733|NCT00324675|FG000|Participant Flow|Rosiglitazone|
10854734|NCT00324675|FG001|Participant Flow|Placebo|
10854735|NCT00324675|OG000|Outcome|Rosiglitazone|
10854736|NCT00324675|OG001|Outcome|Placebo|
10854737|NCT00324675|EG000|Reported Event|Rosiglitazone|
10854738|NCT00324675|EG001|Reported Event|Placebo|
10854739|NCT00324701|BG000|Baseline|Telepsychology|therapy done at patients house using in-home video conferencing technology
10854740|NCT00324701|BG001|Baseline|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
10854741|NCT00324701|BG002|Baseline|Total|Total of all reporting groups
10854742|NCT00324701|FG000|Participant Flow|Telepsychology|therapy done at patients house using in-home video conferencing technology
10854743|NCT00324701|FG001|Participant Flow|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
10854744|NCT00324701|OG000|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
10854745|NCT00324701|OG001|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
10854746|NCT00324701|EG000|Reported Event|Telepsychology|therapy done at patients house using in-home video conferencing technology
10854747|NCT00324701|EG001|Reported Event|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
10854748|NCT00324740|BG000|Baseline|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854749|NCT00324740|FG000|Participant Flow|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.25 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854750|NCT00324740|FG001|Participant Flow|Dose Level 2 Vorinostat (300mg) and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.375 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854751|NCT00324740|FG002|Participant Flow|Dose Level 3: Vorinostat (300mg) and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.5 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854752|NCT00324740|OG000|Outcome|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854753|NCT00324740|OG001|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854754|NCT00324740|OG002|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854755|NCT00324740|OG000|Outcome|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854756|NCT00324740|EG000|Reported Event|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
10854757|NCT00324753|BG000|Baseline|Intervention|"Intervention arm- Prompting by prevention nurses and a communication sheet provided~A prevention nurse addressed the process of communication by activating the patient to initiate and conduct a discussion on colorectal cancer screening at the clinical encounter with their PCP. The prevention nurse also provided a talking guide to the patient which was a double-sided single sheet that contained specific communication content pertinent to colorectal cancer screening that should be addressed with the PCP during the clinical encounter and included specific information on fecal occult blood testing and colonoscopy. The patient and PCP could determine the depth at which the communication occurred depending on factors such as time and competing clinical demands. Included in this talking guide were items designed to assist the PCP in assessing the patient's perception of the communication that occurred during the clinical encounter."
10854758|NCT00324753|BG001|Baseline|Control|"Standard of care brochures~Standard of care: Standard of care brochures"
10854759|NCT00324753|BG002|Baseline|Total|Total of all reporting groups
10854760|NCT00324753|FG000|Participant Flow|Intervention|"Intervention arm- Prompting by prevention nurses and a communication sheet provided~A prevention nurse addressed the process of communication by activating the patient to initiate and conduct a discussion on colorectal cancer screening at the clinical encounter with their PCP. The prevention nurse also provided a talking guide to the patient which was a double-sided single sheet that contained specific communication content pertinent to colorectal cancer screening that should be addressed with the PCP during the clinical encounter and included specific information on fecal occult blood testing and colonoscopy. The patient and PCP could determine the depth at which the communication occurred depending on factors such as time and competing clinical demands. Included in this talking guide were items designed to assist the PCP in assessing the patient's perception of the communication that occurred during the clinical encounter."
11222049|NCT02344576|FG000|Participant Flow|Patient Control|Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
11222050|NCT02344576|FG001|Participant Flow|Patient Intervention|Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
11222051|NCT02344576|FG002|Participant Flow|Caregiver Control|Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
11222052|NCT02344576|FG003|Participant Flow|Caregiver Intervention|Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
11222053|NCT02344576|OG000|Outcome|Patient Intervention|Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
11222054|NCT02344576|OG001|Outcome|Caregiver Intervention|Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
10854761|NCT00324753|FG001|Participant Flow|Control|Usual care arm which consisted of standard of care brochures available clinically. No communication prompts or guides provided for those in Arm 2.
10854762|NCT00324753|OG000|Outcome|Intervention|"Communication sheet~Communication: Communication sheet"
10854763|NCT00324753|OG001|Outcome|Control|"Standard of care brochures~Standard of care: Standard of care brochures"
10854764|NCT00324753|OG000|Outcome|Intervention|"Intervention arm- Prompting by prevention nurses and a communication sheet provided~A prevention nurse addressed the process of communication by activating the patient to initiate and conduct a discussion on colorectal cancer screening at the clinical encounter with their PCP. The prevention nurse also provided a talking guide to the patient which was a double-sided single sheet that contained specific communication content pertinent to colorectal cancer screening that should be addressed with the PCP during the clinical encounter and included specific information on fecal occult blood testing and colonoscopy. The patient and PCP could determine the depth at which the communication occurred depending on factors such as time and competing clinical demands. Included in this talking guide were items designed to assist the PCP in assessing the patient's perception of the communication that occurred during the clinical encounter."
10854765|NCT00324753|OG001|Outcome|Control|Usual care arm which consisted of standard of care brochures available clinically. No communication prompts or guides provided for those in Arm 2.
11222055|NCT02344576|OG000|Outcome|Patient Control|Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
11222056|NCT02344576|OG001|Outcome|Patient Intervention|Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
11222057|NCT02344576|OG002|Outcome|Caregiver Control|Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
11343630|NCT03905863|FG001|Participant Flow|Intervention Arm|Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.
11343631|NCT03905863|OG000|Outcome|Standard of Care Arm|SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardized protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.
11343632|NCT03905863|OG001|Outcome|Intervention Arm|Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.
11343633|NCT03905863|EG000|Reported Event|Standard of Care Arm|Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre which typically includes a primary and secondary dressing to the wound.
11343634|NCT03905863|EG001|Reported Event|Intervention Arm|"Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound.~Natrox® Oxygen Wound Therapy: A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system."
11343635|NCT03907033|BG000|Baseline|Standard Bupivacaine|"Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.~Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect."
11343636|NCT03907033|BG001|Baseline|Liposomal Bupivacaine|"Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments~Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.~Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect."
11343637|NCT03907033|BG002|Baseline|Total|Total of all reporting groups
11343638|NCT03907033|FG000|Participant Flow|Standard Bupivacaine|"Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.~Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect."
11343639|NCT03907033|FG001|Participant Flow|Liposomal Bupivacaine|"Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments~Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.~Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect."
10846091|NCT00272961|EG004|Reported Event|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
10854766|NCT00324753|EG000|Reported Event|Intervention|"Intervention arm- Prompting by prevention nurses and a communication sheet provided~A prevention nurse addressed the process of communication by activating the patient to initiate and conduct a discussion on colorectal cancer screening at the clinical encounter with their PCP. The prevention nurse also provided a talking guide to the patient which was a double-sided single sheet that contained specific communication content pertinent to colorectal cancer screening that should be addressed with the PCP during the clinical encounter and included specific information on fecal occult blood testing and colonoscopy. The patient and PCP could determine the depth at which the communication occurred depending on factors such as time and competing clinical demands. Included in this talking guide were items designed to assist the PCP in assessing the patient's perception of the communication that occurred during the clinical encounter."
10854767|NCT00324753|EG001|Reported Event|Control|Usual care arm which consisted of standard of care brochures available clinically. No communication prompts or guides provided for those in Arm 2.
10854768|NCT00324857|BG000|Baseline|Arm 1/Attention Control|Attention control
10854769|NCT00324857|BG001|Baseline|Arm 2/Decision Aid (DA)|Decision Aid video
10854770|NCT00324857|BG002|Baseline|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
10854771|NCT00324857|BG003|Baseline|Arm 4/ DA and MI|Decision aid and MI
10854772|NCT00324857|BG004|Baseline|Total|Total of all reporting groups
10854773|NCT00324857|FG000|Participant Flow|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
10854774|NCT00324857|FG001|Participant Flow|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
10854775|NCT00324857|FG002|Participant Flow|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
10854776|NCT00324857|FG003|Participant Flow|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
10854777|NCT00324857|OG000|Outcome|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
10854778|NCT00324857|OG001|Outcome|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
11222058|NCT02344576|OG003|Outcome|Caregiver Intervention|Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
10854779|NCT00324857|OG002|Outcome|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
10854780|NCT00324857|OG003|Outcome|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
10854781|NCT00324857|OG000|Outcome|Arm 1/Attention Control|"Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement~Attention control: patients received a booklet."
10854782|NCT00324857|OG001|Outcome|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
11343640|NCT03907033|OG000|Outcome|Standard Bupivacaine|"Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.~Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect."
11343641|NCT03907033|OG001|Outcome|Liposomal Bupivacaine|"Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments~Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.~Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect."
11343642|NCT03907033|EG000|Reported Event|Standard Bupivacaine|"Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.~Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect."
11343643|NCT03907033|EG001|Reported Event|Liposomal Bupivacaine|"Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments~Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.~Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect."
11343644|NCT03909971|BG000|Baseline|Cohort 1|Participants whose disease had progressed after crizotinib as the only anaplastic lymphoma kinase (ALK) inhibitor were enrolled in Cohort 1 to receive lorlatinib 100 mg orally once daily (QD) continuously until confirmed disease progression by Independent Central Radiology (ICR) (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
11343645|NCT03909971|BG001|Baseline|Cohort 2|Participants whose disease had progressed after one ALK inhibitor treatment other than crizotinib, with or without prior crizotinib were enrolled in Cohort 2 to receive lorlatinib100 mg QD continuously until confirmed disease progression by ICR (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
11343646|NCT03909971|BG002|Baseline|Total|Total of all reporting groups
11343647|NCT03909971|FG000|Participant Flow|Cohort 1|Participants whose disease had progressed after crizotinib as the only anaplastic lymphoma kinase (ALK) inhibitor were enrolled in Cohort 1 to receive lorlatinib 100 mg orally once daily (QD) continuously until confirmed disease progression by Independent Central Radiology (ICR) (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
11343648|NCT03909971|FG001|Participant Flow|Cohort 2|Participants whose disease had progressed after one ALK inhibitor treatment other than crizotinib, with or without prior crizotinib were enrolled in Cohort 2 to receive lorlatinib100 mg QD continuously until confirmed disease progression by ICR (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
11343649|NCT03909971|OG000|Outcome|Cohort 1|Participants whose disease had progressed after crizotinib as the only anaplastic lymphoma kinase (ALK) inhibitor were enrolled in Cohort 1 to receive lorlatinib 100 mg orally once daily (QD) continuously until confirmed disease progression by Independent Central Radiology (ICR) (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
11343650|NCT03909971|OG000|Outcome|Cohort 2|Participants whose disease had progressed after one ALK inhibitor treatment other than crizotinib, with or without prior crizotinib were enrolled in Cohort 2 to receive lorlatinib100 mg QD continuously until confirmed disease progression by ICR (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
10854783|NCT00324857|OG002|Outcome|Arm 3/ Motivational Interview (MI)|"Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. The MI session will do the following things: 1) Assessing Readiness, Importance, and Confidence; 2) Eliciting Barriers, Concerns and Positive Motivational; 3) Summarizing Pros and Cons; 4) Assess Patient Values and Goals; 5) Provide a Menu of Options."
10854784|NCT00324857|OG003|Outcome|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain~MI plus Decision aid: Patient viewed the video and then underwent MI."
10854785|NCT00324857|EG000|Reported Event|Arm 1/Attention Control|Attention Control
10854786|NCT00324857|EG001|Reported Event|Arm 2/Decision Aid (DA)|Decision Aid
10854787|NCT00324857|EG002|Reported Event|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
10854788|NCT00324857|EG003|Reported Event|Arm 4/ DA and MI|Decision Aid and MI
10854789|NCT00324870|BG000|Baseline|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
10854790|NCT00324870|FG000|Participant Flow|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
10854791|NCT00324870|OG000|Outcome|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
10854792|NCT00324870|EG000|Reported Event|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
11222059|NCT02344576|OG000|Outcome|Sites|Hospital's left ventricular assist device (LVAD) programs implementing the intervention as the new standard of care at their site. Sites start in the usual care control phase and then are randomly phased into the intervention phase over time. The intervention consists of decision coaching and communication training of staff and use of a decision aid pamphlet and video during patient and caregiver education.
10854793|NCT00324896|BG000|Baseline|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
10854794|NCT00324896|BG001|Baseline|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
10854795|NCT00324896|BG002|Baseline|Total|Total of all reporting groups
10854796|NCT00324896|FG000|Participant Flow|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
10854797|NCT00324896|FG001|Participant Flow|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
10854798|NCT00324896|OG000|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
10854799|NCT00324896|OG001|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
10854800|NCT00324896|EG000|Reported Event|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
10854801|NCT00324896|EG001|Reported Event|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
10854802|NCT00324961|BG000|Baseline|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
10854803|NCT00324961|FG000|Participant Flow|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
10854804|NCT00324961|OG000|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
10854805|NCT00324961|OG000|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
10854806|NCT00324961|OG000|Outcome|10 mg Adefovir Dipivoxil (ADV|10 mg ADV tablets once daily for 104 weeks
10854807|NCT00324961|EG000|Reported Event|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
10854808|NCT00324987|BG000|Baseline|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10854809|NCT00324987|BG001|Baseline|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10854810|NCT00324987|BG002|Baseline|Total|Total of all reporting groups
10854811|NCT00324987|FG000|Participant Flow|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10854812|NCT00324987|FG001|Participant Flow|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10854813|NCT00324987|OG000|Outcome|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10854814|NCT00324987|OG001|Outcome|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11343651|NCT03909971|OG001|Outcome|Cohort 2|Participants whose disease had progressed after one ALK inhibitor treatment other than crizotinib, with or without prior crizotinib were enrolled in Cohort 2 to receive lorlatinib100 mg QD continuously until confirmed disease progression by ICR (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
10854815|NCT00324987|EG000|Reported Event|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10854816|NCT00324987|EG001|Reported Event|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10854817|NCT00325039|BG000|Baseline|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
10854818|NCT00325039|BG001|Baseline|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
10854819|NCT00325039|BG002|Baseline|Total|Total of all reporting groups
10854820|NCT00325039|FG000|Participant Flow|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
10854821|NCT00325039|FG001|Participant Flow|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
10854822|NCT00325039|OG000|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
10854823|NCT00325039|OG001|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
10854824|NCT00325039|EG000|Reported Event|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
10854825|NCT00325039|EG001|Reported Event|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
10854826|NCT00325078|BG000|Baseline|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn's disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
10854827|NCT00325078|BG001|Baseline|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
10854828|NCT00325078|BG002|Baseline|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn's disease (CD). The rate of infections in the CGD patients without IBD are monitored.
10854829|NCT00325078|BG003|Baseline|Total|Total of all reporting groups
10854830|NCT00325078|FG000|Participant Flow|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn's disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
10854831|NCT00325078|FG001|Participant Flow|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
10854832|NCT00325078|FG002|Participant Flow|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn's disease (CD). The rate of infections in the CGD patients without IBD are monitored.
10854833|NCT00325078|OG000|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn's disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
10854834|NCT00325078|OG001|Outcome|Observation|Subjects with IBD without TNFa inhibitor treatment
10854835|NCT00325078|OG002|Outcome|Control Volunteers|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn's disease (CD). The rate of infections in the CGD patients without IBD are monitored.
10854836|NCT00325078|OG001|Outcome|Observation|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
10854837|NCT00325078|EG000|Reported Event|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn's disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
10854838|NCT00325078|EG001|Reported Event|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
10854839|NCT00325078|EG002|Reported Event|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn's disease (CD). The rate of infections in the CGD patients without IBD are monitored.
10854840|NCT00325130|BG000|Baseline|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
10854841|NCT00325130|BG001|Baseline|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
10854842|NCT00325130|BG002|Baseline|Total|Total of all reporting groups
11222060|NCT02344576|OG000|Outcome|Caregiver Control|Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
11222061|NCT02344576|EG000|Reported Event|Patient Control|Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
11222062|NCT02344576|EG001|Reported Event|Patient Intervention|Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
10854843|NCT00325130|FG000|Participant Flow|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
10854844|NCT00325130|FG001|Participant Flow|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
10854845|NCT00325130|OG000|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
10854846|NCT00325130|OG001|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
10854847|NCT00325130|EG000|Reported Event|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
10854848|NCT00325130|EG001|Reported Event|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
10854849|NCT00325143|BG000|Baseline|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
10854850|NCT00325143|FG000|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
10854851|NCT00325143|OG000|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
10854852|NCT00325143|EG000|Reported Event|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
10854853|NCT00325156|BG000|Baseline|Infanrix-IPV+ Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
10854854|NCT00325156|FG000|Participant Flow|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
10854855|NCT00325156|OG000|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
10854856|NCT00325156|EG000|Reported Event|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
10854857|NCT00325195|BG000|Baseline|q2 Wks|8 mg pegloticase every 2 weeks
10854858|NCT00325195|BG001|Baseline|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
10854859|NCT00325195|BG002|Baseline|Placebo|placebo infusion every 2 weeks
10854860|NCT00325195|BG003|Baseline|Total|Total of all reporting groups
10854861|NCT00325195|FG000|Participant Flow|q2 Wks|8 mg pegloticase every 2 weeks
10854862|NCT00325195|FG001|Participant Flow|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
10854863|NCT00325195|FG002|Participant Flow|Placebo|placebo infusion every 2 weeks
10854864|NCT00325195|OG000|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
10854865|NCT00325195|OG001|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
11222063|NCT02344628|BG000|Baseline|AZT30|"Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams~Azithromycin: Comparison of two different dosing strategies for the treatment of yaws"
10854866|NCT00325195|OG002|Outcome|Placebo|placebo infusion every 2 weeks
10854867|NCT00325195|EG000|Reported Event|q2 Wks|8 mg pegloticase every 2 weeks
10854868|NCT00325195|EG001|Reported Event|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
10854869|NCT00325195|EG002|Reported Event|Placebo|placebo infusion every 2 weeks
10854870|NCT00325234|BG000|Baseline|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
11222064|NCT02344628|BG001|Baseline|AZT20|"Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams~Azithromycin: Comparison of two different dosing strategies for the treatment of yaws"
11222065|NCT02344628|BG002|Baseline|Total|Total of all reporting groups
10854871|NCT00325234|BG001|Baseline|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
10854872|NCT00325234|BG002|Baseline|Total|Total of all reporting groups
10854873|NCT00325234|FG000|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
10854874|NCT00325234|FG001|Participant Flow|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
10854875|NCT00325234|OG000|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
10854876|NCT00325234|OG001|Outcome|Gemcitabine/Vinorelbine|Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
10854877|NCT00325234|OG000|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
10854878|NCT00325234|OG001|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
10854879|NCT00325234|EG000|Reported Event|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
10854880|NCT00325234|EG001|Reported Event|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
11222066|NCT02344628|FG000|Participant Flow|AZT30|"Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams~Azithromycin: Comparison of two different dosing strategies for the treatment of yaws"
11343652|NCT03909971|EG000|Reported Event|Cohort 1|Participants whose disease had progressed after crizotinib as the only anaplastic lymphoma kinase (ALK) inhibitor were enrolled in Cohort 1 to receive lorlatinib 100 mg orally once daily (QD) continuously until confirmed disease progression by Independent Central Radiology (ICR) (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
11343653|NCT03909971|EG001|Reported Event|Cohort 2|Participants whose disease had progressed after one ALK inhibitor treatment other than crizotinib, with or without prior crizotinib were enrolled in Cohort 2 to receive lorlatinib100 mg QD continuously until confirmed disease progression by ICR (unless clinical benefit is still achievable), global deterioration of health status requiring permanent discontinuation, unacceptable toxicity, pregnancy, significant protocol violation, patient lost to follow-up, or patient refusal, study terminated by the sponsor, or death, whichever comes first. Each cycle duration was 21 days.
11343654|NCT03920215|BG000|Baseline|OC-01 Low Dose, 0.12 mg/mL|"OC-01 (varenicline) nasal spray, 0.12 mg/mL~OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray"
11343655|NCT03920215|BG001|Baseline|OC-01 Mid Dose, 0.6 mg/mL|"OC-01 (varenicline) nasal spray, 0.62 mg/mL~OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray"
11343656|NCT03920215|BG002|Baseline|OC-01 High Dose, 1.2 mg/mL|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray"
11343657|NCT03920215|BG003|Baseline|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11343658|NCT03920215|BG004|Baseline|Total|Total of all reporting groups
11343659|NCT03920215|FG000|Participant Flow|OC-01 Low Dose, 0.12 mg/mL|"OC-01 (varenicline) nasal spray, 0.12 mg/mL~OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray"
11343660|NCT03920215|FG001|Participant Flow|OC-01 Mid Dose, 0.6 mg/mL|"OC-01 (varenicline) nasal spray, 0.62 mg/mL~OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray"
11343661|NCT03920215|FG002|Participant Flow|OC-01 High Dose, 1.2 mg/mL|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray"
11343662|NCT03920215|FG003|Participant Flow|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11343663|NCT03920215|OG000|Outcome|OC-01 Low Dose, 0.12 mg/mL|"OC-01 (varenicline) nasal spray, 0.12 mg/mL~OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray"
11343664|NCT03920215|OG001|Outcome|OC-01 Mid Dose, 0.6 mg/mL|"OC-01 (varenicline) nasal spray, 0.62 mg/mL~OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray"
11343665|NCT03920215|OG002|Outcome|OC-01 High Dose, 1.2 mg/mL|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray"
11343666|NCT03920215|OG003|Outcome|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11343667|NCT03920215|EG000|Reported Event|OC-01 Low Dose, 0.12 mg/mL|"OC-01 (varenicline) nasal spray, 0.12 mg/mL~OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray"
11343668|NCT03920215|EG001|Reported Event|OC-01 Mid Dose, 0.6 mg/mL|"OC-01 (varenicline) nasal spray, 0.62 mg/mL~OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray"
11343669|NCT03920215|EG002|Reported Event|OC-01 High Dose, 1.2 mg/mL|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray"
11343670|NCT03920215|EG003|Reported Event|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11343671|NCT03921151|BG000|Baseline|Cocaine-dependent|"Participants who use and are dependent on cocaine~Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment."
11343672|NCT03921151|BG001|Baseline|Non-drug Using Healthy Controls|"Participants who are not drug users~Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment."
11343673|NCT03921151|BG002|Baseline|Total|Total of all reporting groups
11343674|NCT03921151|FG000|Participant Flow|Cocaine-dependent|"Participants who use and are dependent on cocaine~Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment."
11343675|NCT03921151|FG001|Participant Flow|Non-drug Using Healthy Controls|"Participants who are not drug users~Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment."
11343676|NCT03921151|OG000|Outcome|Cocaine-dependent|"Participants who use and are dependent on cocaine~Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment."
10854881|NCT00325403|BG000|Baseline|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
10854882|NCT00325403|BG001|Baseline|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population
10854883|NCT00325403|BG002|Baseline|Total|Total of all reporting groups
10975799|NCT00937521|EG007|Reported Event|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.
10975800|NCT00937521|EG008|Reported Event|B+OMV (Group I) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
10975801|NCT00937521|EG009|Reported Event|B+½ OMV (Group II) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
10975802|NCT00937521|EG010|Reported Event|B+1/4 OMV (Group III) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
10975803|NCT00937521|EG011|Reported Event|B (Group IV) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
10975804|NCT00937521|EG012|Reported Event|½ (B+OMV) (Group V) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
10975805|NCT00937521|EG013|Reported Event|PH2 B+OMV (Group VI) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
10975806|NCT00937521|EG014|Reported Event|MenC (Group VII) Booster Phase|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.~Group defined to include Booster Phase."
10975807|NCT00937521|EG015|Reported Event|Par+B+OMV (Group VIII) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
10975808|NCT00937547|BG000|Baseline|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
10975809|NCT00937547|BG001|Baseline|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
10975810|NCT00937547|BG002|Baseline|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
10975811|NCT00937547|BG003|Baseline|Total|Total of all reporting groups
10975812|NCT00937547|FG000|Participant Flow|Invasive Cervical Cancer|patients with histologic diagnosis invasive cervical cancer.
10975813|NCT00937547|FG001|Participant Flow|Cervical Intraepithelial Neoplasia 2|patients with histological diagnosis of cervical intraepithelial neoplasia grade 2
10975814|NCT00937547|FG002|Participant Flow|Cervical Intraepithelial Neoplasia 3|patients with histological diagnosis of cervical intraepithelial neoplasia grade 3
10975815|NCT00937547|OG000|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
10975816|NCT00937547|OG001|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
10975817|NCT00937547|OG002|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
10975818|NCT00937547|EG000|Reported Event|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
10975819|NCT00937547|EG001|Reported Event|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
10975820|NCT00937547|EG002|Reported Event|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
10975821|NCT00937560|BG000|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
10975822|NCT00937560|FG000|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of each cycle, paclitaxel 80 milligrams per square meters of body surface (mg/m^2) IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an area under the curve (AUC) of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (milligrams [mg] equals [=] [glomerular filtration rate (GFR) + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
11007013|NCT01089062|BG004|Baseline|Treatment C, Then A, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
11222067|NCT02344628|FG001|Participant Flow|AZT20|"Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams~Azithromycin: Comparison of two different dosing strategies for the treatment of yaws"
10975823|NCT00937560|OG000|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
10975824|NCT00937560|EG000|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. Bevacizumab: Bevacizumab was supplied as a sterile solution for infusion. Paclitaxel: Paclitaxel was supplied locally in commercial batches. Carboplatin: Carboplatin was supplied locally in commercial batches.
10975825|NCT00937768|BG000|Baseline|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
10975826|NCT00937768|BG001|Baseline|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
10975827|NCT00937768|BG002|Baseline|Total|Total of all reporting groups
10975828|NCT00937768|FG000|Participant Flow|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
10975829|NCT00937768|FG001|Participant Flow|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
10975830|NCT00937768|OG000|Outcome|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
10975831|NCT00937768|OG001|Outcome|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
10975832|NCT00937768|EG000|Reported Event|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
10975833|NCT00937768|EG001|Reported Event|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
10975834|NCT00937794|BG000|Baseline|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
10975835|NCT00937794|FG000|Participant Flow|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
10975836|NCT00937794|OG000|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
10975837|NCT00937794|EG000|Reported Event|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
10975838|NCT00937833|BG000|Baseline|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
10975839|NCT00937833|BG001|Baseline|Control|No sling placed at the time of prostatectomy
10975840|NCT00937833|BG002|Baseline|Total|Total of all reporting groups
10975841|NCT00937833|FG000|Participant Flow|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
10975842|NCT00937833|FG001|Participant Flow|Control|No sling placed at the time of prostatectomy
10975843|NCT00937833|OG000|Outcome|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
10975844|NCT00937833|OG001|Outcome|Control|No sling placed at the time of prostatectomy
10975845|NCT00937833|EG000|Reported Event|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
10975846|NCT00937833|EG001|Reported Event|Control|No sling placed at the time of prostatectomy
10975847|NCT00937859|BG000|Baseline|SER120|All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
10975848|NCT00937859|BG001|Baseline|Placebo|All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
10975849|NCT00937859|BG002|Baseline|Total|Total of all reporting groups
10975850|NCT00937859|FG000|Participant Flow|SER120|All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
10975851|NCT00937859|FG001|Participant Flow|Placebo|All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study.
10975852|NCT00937859|OG000|Outcome|SER120|All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
10975853|NCT00937859|OG001|Outcome|Placebo|All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
10975854|NCT00937859|EG000|Reported Event|SER120|All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
10975855|NCT00937859|EG001|Reported Event|Placebo|All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
10975856|NCT00937950|BG000|Baseline|HPV-052 Study Subjects Group|The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
10975857|NCT00937950|FG000|Participant Flow|HPV-052 Study Subjects Group|The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
10975858|NCT00937950|OG000|Outcome|HPV-052 Study Subjects Group|The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
10975859|NCT00937950|EG000|Reported Event|HPV-052 Study Subjects Group|The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
10975860|NCT00938015|BG000|Baseline|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
10975861|NCT00938015|FG000|Participant Flow|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
10975862|NCT00938015|OG000|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
10975863|NCT00938015|EG000|Reported Event|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
11222068|NCT02344628|OG000|Outcome|AZT30|"Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams~Azithromycin: Comparison of two different dosing strategies for the treatment of yaws"
11222069|NCT02344628|OG001|Outcome|AZT20|"Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams~Azithromycin: Comparison of two different dosing strategies for the treatment of yaws"
11222070|NCT02344628|EG000|Reported Event|AZT30|"Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams~Azithromycin: Comparison of two different dosing strategies for the treatment of yaws"
11222071|NCT02344628|EG001|Reported Event|AZT20|"Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams~Azithromycin: Comparison of two different dosing strategies for the treatment of yaws"
11222072|NCT02344745|BG000|Baseline|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
11222073|NCT02344745|BG001|Baseline|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
11222074|NCT02344745|BG002|Baseline|Total|Total of all reporting groups
11222075|NCT02344745|FG000|Participant Flow|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
11222076|NCT02344745|FG001|Participant Flow|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
11222077|NCT02344745|OG000|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
11222078|NCT02344745|OG001|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
11222079|NCT02344745|EG000|Reported Event|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
11007014|NCT01089062|BG005|Baseline|Treatment C, Then B, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
11007015|NCT01089062|BG006|Baseline|Total|Total of all reporting groups
11007016|NCT01089062|FG000|Participant Flow|Treatment A, Then B, Then C|"The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment A = inhaler placebo and Intravenous (IV) Dihydroergotamine (DHE) for first dose, inhaler placebo for second dose at Visit 2.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
11007017|NCT01089062|FG001|Participant Flow|Treatment A, Then C, Then B|"The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
10975864|NCT00938041|BG000|Baseline|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
10975865|NCT00938041|FG000|Participant Flow|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
10975866|NCT00938041|OG000|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
11098868|NCT01578551|BG000|Baseline|Arm A|"Metformin starting at a dose of 500 mg twice a day, orally with meals. After one week, increase the dose of metformin to 1000 mg as the first dose of the day and 500 mg as the second dose. After another week, increase to 1000 mg of metformin two times a day. Metformin treatment will be initiated one week before beginning chemotherapy, if possible, but chemotherapy will not be delayed for metformin loading.~Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle.~.~Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Paclitaxel + Carbop"
11098869|NCT01578551|BG001|Baseline|Arm B|"Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle. Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy.~Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy~Bevacizumab: All patients will receive the drug at 15 mg/kg every 21 days, given immediately after completion of chemotherapy, starting with"
11098870|NCT01578551|BG002|Baseline|Total|Total of all reporting groups
11098871|NCT01578551|FG000|Participant Flow|Arm A|"Metformin dose of 500 mg twice a day After one week, increase dose of metformin to 1000 mg as the first dose of the day and 500 mg as the second dose. After another week, increase to 1000 mg of metformin two times a day. Metformin tx initiated 1 week before beginning chemotherapy, chemotherapy not delayed for metformin loading.~Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle. Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy.~Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Bevacizumab: 15 mg/kg every 21 days, every 21 days until PD"
11098872|NCT01578551|FG001|Participant Flow|Arm B|"Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle.~Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy~Bevacizumab: All patients will receive the drug at 15 mg/kg every 21 days, given immediately after completion of chemotherapy, starting with Cycle 1. After induction chemotherapy is completed (4 cycles), bevacizumab will continue at 15 mg/kg every 21 days until PD (provided neither PD nor toxicity requiring discontinuation has occurred) measured from date of first dose of bevacizumab."
11098873|NCT01578551|OG000|Outcome|Arm A|"Metformin 500 mg twice a day, orally with meals. After one week, increase 1000 mg as the first dose of the day and 500 mg as the second dose. After another week, increase to 1000 mg of metformin two times a day. Metformin treatment will be initiated one week before beginning chemotherapy, if possible, but chemotherapy will not be delayed for metformin loading.~Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle. Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy~Bevacizumab: 15 mg/kg every 21 days, Metformin: 1000 mg twice daily with food."
10975867|NCT00938041|EG000|Reported Event|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
10975868|NCT00938314|BG000|Baseline|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
10975869|NCT00938314|BG001|Baseline|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
10975870|NCT00938314|BG002|Baseline|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
10975871|NCT00938314|BG003|Baseline|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
10975872|NCT00938314|BG004|Baseline|Total|Total of all reporting groups
10975873|NCT00938314|FG000|Participant Flow|NTx®-265 Low Dose|human chorionic gonadotropin (hCG) 385 µg (10,000 international unit [IU]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then epoetin alfa (EPO) 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
10975874|NCT00938314|FG001|Participant Flow|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
10975875|NCT00938314|FG002|Participant Flow|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
10975876|NCT00938314|FG003|Participant Flow|Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
10975877|NCT00938314|OG000|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
10975878|NCT00938314|OG001|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
10975879|NCT00938314|OG002|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
10975880|NCT00938314|OG003|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
10975881|NCT00938314|EG000|Reported Event|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
10975882|NCT00938314|EG001|Reported Event|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
10975883|NCT00938314|EG002|Reported Event|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
10975884|NCT00938314|EG003|Reported Event|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
10975885|NCT00938327|BG000|Baseline|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
10975886|NCT00938327|FG000|Participant Flow|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
10975887|NCT00938327|OG000|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
10975888|NCT00938327|EG000|Reported Event|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
10975889|NCT00938340|BG000|Baseline|All Completed Participants (n=15)|Whole walnut (85 g) Walnut skins (5.6 g) Walnut oil (51 g) Defatted walnut nutmeat (34 g)
11126266|NCT01784848|OG001|Outcome|Clinical Treatment|"Optimized clinical treatment including medical management of hypertension.~Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction."
11126267|NCT01784848|EG000|Reported Event|Laparoscopic Roux-en-Y Gastric Bypass|"Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.~Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery~Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction."
11126268|NCT01784848|EG001|Reported Event|Clinical Treatment|"Optimized clinical treatment including medical management of hypertension.~Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction."
11126269|NCT01648205|BG000|Baseline|All Participants|There were 25 subjects that started the study receiving placebo for 1 month.
11126270|NCT01648205|FG000|Participant Flow|Placebo|There were 25 subjects enrolled receiving placebo for 1 month with ECG to be obtained at baseline and at 1 month.
11126271|NCT01648205|OG000|Outcome|Placebo|Placebo was administered for 1 month.
11126272|NCT01648205|OG001|Outcome|Ranolazine at 2 Months|Ranolazine was administered after 1 month
11126273|NCT01648205|OG000|Outcome|Placebo|Placebo administered at first month.
10975890|NCT00938340|FG000|Participant Flow|Walnut Intervention|Four different treatments were provided to each participant in a randomized-crossover fashion: ground whole walnuts (85 g), walnut skins (5.6 g) derived from whole walnuts, walnut oil (51 g) extracted from whole walnuts, or skinless, defatted walnut nutmeat (34 g) from whole walnuts. Each treatment was incorporated into an inert food carrier.
10975891|NCT00938340|OG000|Outcome|Whole Walnut (85 g)|
10975892|NCT00938340|OG001|Outcome|Walnut Skins (5.6 g)|
10975893|NCT00938340|OG002|Outcome|Walnut Oil (51 g)|
10975894|NCT00938340|OG003|Outcome|Defatted Walnut Nutmeat (34 g)|
10975895|NCT00938340|OG000|Outcome|Whole Walnut (60 Min)|
10975896|NCT00938340|OG001|Outcome|Whole Walnut (120 Min)|
10975897|NCT00938340|OG002|Outcome|Whole Walnut (240 Min)|
10975898|NCT00938340|OG003|Outcome|Whole Walnut (360 Min)|
10975899|NCT00938340|OG004|Outcome|Walnut Skins (60 Min)|
10975900|NCT00938340|OG005|Outcome|Walnut Skins (120 Min)|
10975901|NCT00938340|OG006|Outcome|Walnut Skins (240 Min)|
10975902|NCT00938340|OG007|Outcome|Walnut Skins (360 Min)|
10975903|NCT00938340|OG008|Outcome|Walnut Oil (60 Min)|
10975904|NCT00938340|OG009|Outcome|Walnut Oil (120 Min)|
11222080|NCT02344745|EG001|Reported Event|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
10975905|NCT00938340|OG010|Outcome|Walnut Oil (240 Min)|
10975906|NCT00938340|OG011|Outcome|Walnut Oil (360 Min)|
10975907|NCT00938340|OG012|Outcome|Defatted Walnut Nutmeat (60 Min)|
10975908|NCT00938340|OG013|Outcome|Defatted Walnut Nutmeat (120 Min)|
10975909|NCT00938340|OG014|Outcome|Defatted Walnut Nutmeat (240 Min)|
10975910|NCT00938340|OG015|Outcome|Defatted Walnut Nutmeat (360 Min)|
10975911|NCT00938340|OG000|Outcome|Whole Walnut (30 Min)|
10975912|NCT00938340|OG001|Outcome|Whole Walnut (60 Min)|
10975913|NCT00938340|OG002|Outcome|Whole Walnut (120 Min)|
10975914|NCT00938340|OG003|Outcome|Whole Walnut (240 Min)|
10975915|NCT00938340|OG004|Outcome|Whole Walnut (360 Min)|
10975916|NCT00938340|OG005|Outcome|Walnut Skins (30 Min)|
10975917|NCT00938340|OG006|Outcome|Walnut Skins (60 Min)|
10975918|NCT00938340|OG007|Outcome|Walnut Skins (120 Min)|
10975919|NCT00938340|OG008|Outcome|Walnut Skins (240 Min)|
10975920|NCT00938340|OG009|Outcome|Walnut Skins (360 Min)|
10975921|NCT00938340|OG010|Outcome|Walnut Oil (30 Min)|
10975922|NCT00938340|OG011|Outcome|Walnut Oil (60 Min)|
10975923|NCT00938340|OG012|Outcome|Walnut Oil (120 Min)|
10975924|NCT00938340|OG013|Outcome|Walnut Oil (240 Min)|
10975925|NCT00938340|OG014|Outcome|Walnut Oil (360 Min)|
10975926|NCT00938340|OG015|Outcome|Defatted Walnut Nutmeat (30 Min)|
10975927|NCT00938340|OG016|Outcome|Defatted Walnut Nutmeat (60 Min)|
10975928|NCT00938340|OG017|Outcome|Defatted Walnut Nutmeat (120 Min)|
10975929|NCT00938340|OG018|Outcome|Defatted Walnut Nutmeat (240 Min)|
10975930|NCT00938340|OG019|Outcome|Defatted Walnut Nutmeat (360 Min)|
10975931|NCT00938340|EG000|Reported Event|Walnut Oil|
10975932|NCT00938340|EG001|Reported Event|Whole Walnut|
10975933|NCT00938340|EG002|Reported Event|Walnut Skins|
10975934|NCT00938340|EG003|Reported Event|Defatted Walnut Nutmeat|
10975935|NCT00938366|BG000|Baseline|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
10975936|NCT00938366|BG001|Baseline|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
10975937|NCT00938366|BG002|Baseline|Total|Total of all reporting groups
10975938|NCT00938366|FG000|Participant Flow|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
10975939|NCT00938366|FG001|Participant Flow|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
10975940|NCT00938366|OG000|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
10975941|NCT00938366|OG001|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
10975942|NCT00938366|EG000|Reported Event|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
10975943|NCT00938366|EG001|Reported Event|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
10975944|NCT00938392|BG000|Baseline|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
11222081|NCT02345031|BG000|Baseline|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
11222082|NCT02345031|BG001|Baseline|(AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
11222083|NCT02345031|BG002|Baseline|Total|Total of all reporting groups
11222084|NCT02345031|FG000|Participant Flow|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
11222085|NCT02345031|FG001|Participant Flow|(AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
11222086|NCT02345031|OG000|Outcome|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
11222087|NCT02345031|OG001|Outcome|(AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
11222088|NCT02345031|OG001|Outcome|Placebo (AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
10854884|NCT00325403|FG000|Participant Flow|Placebo|These subjects were randomly allocated to receive matching oral placebo twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
10854885|NCT00325403|FG001|Participant Flow|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
10854886|NCT00325403|OG000|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
10854887|NCT00325403|OG001|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
10854888|NCT00325403|OG000|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
10854889|NCT00325403|OG001|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
11222089|NCT02345031|OG001|Outcome|Placebo|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
11222090|NCT02345031|EG000|Reported Event|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
11222091|NCT02345031|EG001|Reported Event|Placebo (AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
10854890|NCT00325403|EG000|Reported Event|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
10854891|NCT00325403|EG001|Reported Event|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
10854892|NCT00325416|BG000|Baseline|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
10854893|NCT00325416|BG001|Baseline|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
10854894|NCT00325416|BG002|Baseline|Total|Total of all reporting groups
10854895|NCT00325416|FG000|Participant Flow|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
10854896|NCT00325416|FG001|Participant Flow|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
10854897|NCT00325416|OG000|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
10975945|NCT00938392|BG001|Baseline|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
10975946|NCT00938392|BG002|Baseline|Total|Total of all reporting groups
10975947|NCT00938392|FG000|Participant Flow|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
10975948|NCT00938392|FG001|Participant Flow|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
10975949|NCT00938392|OG000|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
10975950|NCT00938392|OG001|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
10975951|NCT00938392|EG000|Reported Event|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
10975952|NCT00938392|EG001|Reported Event|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
10975953|NCT00938431|BG000|Baseline|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975954|NCT00938431|BG001|Baseline|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975955|NCT00938431|BG002|Baseline|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975956|NCT00938431|BG003|Baseline|Total Title|
10975957|NCT00938431|FG000|Participant Flow|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975958|NCT00938431|FG001|Participant Flow|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975959|NCT00938431|FG002|Participant Flow|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975960|NCT00938431|OG000|Outcome|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975961|NCT00938431|OG001|Outcome|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975962|NCT00938431|OG002|Outcome|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975963|NCT00938431|OG000|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975964|NCT00938431|OG001|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975965|NCT00938431|OG002|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975966|NCT00938431|OG000|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
10975967|NCT00938431|EG000|Reported Event|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975968|NCT00938431|EG001|Reported Event|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975969|NCT00938431|EG002|Reported Event|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
10975970|NCT00938457|BG000|Baseline|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
10975971|NCT00938457|FG000|Participant Flow|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
10975972|NCT00938457|OG000|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
10975973|NCT00938457|EG000|Reported Event|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
10975974|NCT00938470|BG000|Baseline|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
10975975|NCT00938470|BG001|Baseline|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
10975976|NCT00938470|BG002|Baseline|Total|Total of all reporting groups
10975977|NCT00938470|FG000|Participant Flow|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
10975978|NCT00938470|FG001|Participant Flow|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
10975979|NCT00938470|OG000|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
10975980|NCT00938470|OG001|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
10975981|NCT00938470|EG000|Reported Event|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
10975982|NCT00938470|EG001|Reported Event|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
10975983|NCT00938548|BG000|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
10975984|NCT00938548|BG001|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
11222092|NCT02345161|BG000|Baseline|FF/UMEC/VI 100/62.5/25 µg|Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222093|NCT02345161|BG001|Baseline|BUD/FOR 400/12 µg|Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222094|NCT02345161|BG002|Baseline|Total|Total of all reporting groups
11222095|NCT02345161|FG000|Participant Flow|FF/UMEC/VI 100/62.5/25 µg|Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222096|NCT02345161|FG001|Participant Flow|BUD/FOR 400/12 µg|Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222097|NCT02345161|OG000|Outcome|FF/UMEC/VI 100/62.5/25 µg|Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222098|NCT02345161|OG001|Outcome|BUD/FOR 400/12 µg|Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222099|NCT02345161|OG000|Outcome|FF/UMEC/VI 100/62.5/25 µg|Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA DPI once daily in the morning and placebo via the Turbuhaler BID for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222100|NCT02345161|OG000|Outcome|FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg)|Each subject will inhale once from their ELLIPTA DPI and once from the reservoir inhaler in the morning and once from the reservoir inhaler in the evening, for 24 weeks (or 52 weeks for subjects participating in the extension part of the study). Subjects will receive FF/UMEC/VI (100mcg/62.5mcg/25mcg) via the ELLIPTA DPI and placebo via reservoir inhaler.
11222101|NCT02345161|OG001|Outcome|Budesonide/Formoterol (400 mcg/12 mcg)|Each subject will inhale once from their ELLIPTA DPI and once from the reservoir inhaler in the morning and once from the reservoir inhaler in the evening, for 24 weeks (or 52 weeks for subjects participating in the extension part of the study). Subjects will receive Budesonide/formoterol (400mcg/12mcg) via reservoir inhaler and placebo via the ELLIPTA DPI.
11222102|NCT02345161|OG001|Outcome|BUD/FOR 400/12 µg|Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study
11222103|NCT02345161|OG000|Outcome|Overall Study Arm|Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA DPI once daily in the morning and placebo via the Turbuhaler BID for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222104|NCT02345161|EG000|Reported Event|FF/UMEC/VI 100/62.5/25 µg|Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
10975985|NCT00938548|BG002|Baseline|Total|Total of all reporting groups
10975986|NCT00938548|FG000|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
10975987|NCT00938548|FG001|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
10975988|NCT00938548|OG000|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
10975989|NCT00938548|OG001|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
10854898|NCT00325416|OG001|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
10854899|NCT00325416|EG000|Reported Event|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
10854900|NCT00325416|EG001|Reported Event|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
10854901|NCT00325442|BG000|Baseline|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
10854902|NCT00325442|BG001|Baseline|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
10854903|NCT00325442|BG002|Baseline|Total|Total of all reporting groups
10854904|NCT00325442|FG000|Participant Flow|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
10854905|NCT00325442|FG001|Participant Flow|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
10854906|NCT00325442|OG000|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
10854907|NCT00325442|OG001|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
10854908|NCT00325442|OG000|Outcome|Less Than 1 mg or Discontinuation Due to Adverse Events|Subjects in this group received less than or equal to 1 mg oral treprostinil twice daily or discontinued treatment due to adverse events.
10854909|NCT00325442|OG001|Outcome|1.25 - 3.25 mg|Subjects in this group recieved 1.25 to 3.25 mg oral treprostinil twice daily.
10854910|NCT00325442|OG002|Outcome|3.5 - 16 mg|Subjects in this group received 3.5 to 16 mg oral treprostinil twice daily.
10854911|NCT00325442|EG000|Reported Event|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
10854912|NCT00325442|EG001|Reported Event|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
10854913|NCT00325468|BG000|Baseline|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
10854914|NCT00325468|BG001|Baseline|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
10854915|NCT00325468|BG002|Baseline|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
10854916|NCT00325468|BG003|Baseline|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
10854917|NCT00325468|BG004|Baseline|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
10854918|NCT00325468|BG005|Baseline|Total|Total of all reporting groups
10854919|NCT00325468|FG000|Participant Flow|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
10854920|NCT00325468|FG001|Participant Flow|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
10854921|NCT00325468|FG002|Participant Flow|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
10854922|NCT00325468|FG003|Participant Flow|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
10854923|NCT00325468|FG004|Participant Flow|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
10854924|NCT00325468|OG000|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
10854925|NCT00325468|OG001|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
10975990|NCT00938548|EG000|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
11222105|NCT02345161|EG001|Reported Event|BUD/FOR 400/12 µg|Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
11222106|NCT02345226|BG000|Baseline|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
11222107|NCT02345226|BG001|Baseline|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
10854926|NCT00325468|OG002|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
10854927|NCT00325468|OG003|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
10854928|NCT00325468|OG004|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
10854929|NCT00325468|EG000|Reported Event|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
10854930|NCT00325468|EG001|Reported Event|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
10854931|NCT00325468|EG002|Reported Event|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
10854932|NCT00325468|EG003|Reported Event|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
10854933|NCT00325468|EG004|Reported Event|Alendronate 70 mg QW|
10854934|NCT00325468|EG005|Reported Event|All Participants|
10854935|NCT00325598|BG000|Baseline|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
10854936|NCT00325598|BG001|Baseline|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
10854937|NCT00325598|BG002|Baseline|Total|Total of all reporting groups
10854938|NCT00325598|FG000|Participant Flow|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
10854939|NCT00325598|FG001|Participant Flow|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
10854940|NCT00325598|OG000|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
10854941|NCT00325598|OG001|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
10854942|NCT00325598|EG000|Reported Event|Cohort 1 (36 Gy) Acute Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 1 through Day 90"
10854943|NCT00325598|EG001|Reported Event|Cohort 1 (36 Gy) Late Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 1 through Day 90"
10854944|NCT00325598|EG002|Reported Event|Cohort 2 (40 Gy) Acute Toxicities|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 91 through end of follow-up"
10854945|NCT00325598|EG003|Reported Event|Cohort 2 (40 Gy) Late Toxicities|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 91 through end of follow-up"
10854946|NCT00325754|BG000|Baseline|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
10854947|NCT00325754|BG001|Baseline|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
10854948|NCT00325754|BG002|Baseline|Total|Total of all reporting groups
10854949|NCT00325754|FG000|Participant Flow|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
10854950|NCT00325754|FG001|Participant Flow|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
11222108|NCT02345226|BG002|Baseline|Total|Total of all reporting groups
11222109|NCT02345226|FG000|Participant Flow|FTC/RPV/TAF|"Double-Blind Phase: Emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) placebo tablet orally once daily for up to 96 weeks.~Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first."
11222110|NCT02345226|FG001|Participant Flow|EFV/FTC/TDF|"Double-Blind Phase: EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.~Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first."
10975991|NCT00938548|EG001|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
10975992|NCT00938639|BG000|Baseline|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10975993|NCT00938639|BG001|Baseline|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10975994|NCT00938639|BG002|Baseline|Total|Total of all reporting groups
10975995|NCT00938639|FG000|Participant Flow|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10975996|NCT00938639|FG001|Participant Flow|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10975997|NCT00938639|OG000|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10975998|NCT00938639|OG001|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10975999|NCT00938639|OG000|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10976000|NCT00938639|OG001|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10976001|NCT00938639|OG002|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10976002|NCT00938639|OG003|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10976003|NCT00938639|EG000|Reported Event|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10976004|NCT00938639|EG001|Reported Event|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
10976005|NCT00938704|BG000|Baseline|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
10976006|NCT00938704|BG001|Baseline|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
10976007|NCT00938704|BG002|Baseline|Total|Total of all reporting groups
10976008|NCT00938704|FG000|Participant Flow|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
10976009|NCT00938704|FG001|Participant Flow|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
10976010|NCT00938704|OG000|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
10976011|NCT00938704|OG001|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
10976012|NCT00938704|EG000|Reported Event|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
10976013|NCT00938704|EG001|Reported Event|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
10976014|NCT00938717|BG000|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
10976015|NCT00938717|BG001|Baseline|Linaclotide|Linaclotide 290μg, oral administration, once per day.
10976016|NCT00938717|BG002|Baseline|Total|Total of all reporting groups
10976017|NCT00938717|FG000|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
10976018|NCT00938717|FG001|Participant Flow|Linaclotide|Linaclotide 290μg, oral administration, once per day.
10976019|NCT00938717|OG000|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
10976020|NCT00938717|OG001|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
10976021|NCT00938717|EG000|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
10976022|NCT00938717|EG001|Reported Event|Linaclotide|Linaclotide 290μg, oral administration, once per day.
10976023|NCT00938782|BG000|Baseline|1 - SEDLine™ Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.~Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was based on SEDLine™ data (SEDLine™ group)."
10976024|NCT00938782|BG001|Baseline|2 - CONTROL Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.~Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was not based on SEDLine™ data (CONTROL group)"
10976025|NCT00938782|BG002|Baseline|Total|Total of all reporting groups
10976026|NCT00938782|FG000|Participant Flow|1 - SEDLine™ Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
10976027|NCT00938782|FG001|Participant Flow|2- Control Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
10976028|NCT00938782|OG000|Outcome|1 - Sedline Group|Patient group randomized to active monitoring with Sedline monitor.
10976029|NCT00938782|OG001|Outcome|2 - Control Group|Patient groups randomized to active monitoring versus blinded monitoring. This group had teh clinician blinded to output of the Sedline monitor.
10976030|NCT00938782|EG000|Reported Event|1 - SEDLine Group|Patient groups randomized to active monitoring. This group had Sedline monitor used to titrate anesthesia.
10976031|NCT00938782|EG001|Reported Event|Group 2 - Control Group|Patient groups randomized to monitoring with blinded data not used to titrate anesthesia.
10976032|NCT00938860|BG000|Baseline|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
10976033|NCT00938860|BG001|Baseline|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
11222111|NCT02345226|OG000|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
10854951|NCT00325754|OG000|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
10854952|NCT00325754|OG001|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
10854953|NCT00325754|EG000|Reported Event|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
10854954|NCT00325754|EG001|Reported Event|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
10854955|NCT00325780|BG000|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10854956|NCT00325780|FG000|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10854957|NCT00325780|OG000|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10854958|NCT00325780|EG000|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10854959|NCT00325819|BG000|Baseline|Acetaminophen|Subjects who were randomized to receive acetaminophen
10854960|NCT00325819|BG001|Baseline|Placebo|Subjects who were randomized to receive placebo
10854961|NCT00325819|BG002|Baseline|Total|Total of all reporting groups
10854962|NCT00325819|FG000|Participant Flow|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
10878878|NCT00454649|BG000|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
10878879|NCT00454649|BG001|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878880|NCT00454649|BG002|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878881|NCT00454649|BG003|Baseline|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
10878882|NCT00454649|BG004|Baseline|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878883|NCT00454649|BG005|Baseline|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
10878884|NCT00454649|BG006|Baseline|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
10878885|NCT00454649|BG007|Baseline|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
10878886|NCT00454649|BG008|Baseline|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
10878887|NCT00454649|BG009|Baseline|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
10878888|NCT00454649|BG010|Baseline|Total|Total of all reporting groups
10976034|NCT00938860|BG002|Baseline|Total|Total of all reporting groups
10976035|NCT00938860|FG000|Participant Flow|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
10976036|NCT00938860|FG001|Participant Flow|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
10976037|NCT00938860|OG000|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
10976038|NCT00938860|OG001|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
10976039|NCT00938860|EG000|Reported Event|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
10976040|NCT00938860|EG001|Reported Event|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
11222112|NCT02345226|OG001|Outcome|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
11222113|NCT02345226|EG000|Reported Event|FTC/RPV/TAF (Double-Blind Phase)|Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TAF group, who received FTC/RPV/TAF (200/25/25 mg) FDC tablet plus EFV/FTC/TDF placebo tablet administered orally once daily.
11222114|NCT02345226|EG001|Reported Event|EFV/FTC/TDF (Double-Blind Phase)|Adverse events reported occurred during the Double-Blind Phase in participants from the EFV/FTC/TDF group, who received EFV/FTC/TDF (600/200/300 mg) FDC tablet plus FTC/RPV/TAF placebo tablet administered orally once daily.
11222115|NCT02345226|EG002|Reported Event|Open-Label FTC/RPV/TAF From FTC/RPV/TAF|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the FTC/RPV/TAF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
10976041|NCT00938886|BG000|Baseline|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
10976042|NCT00938886|BG001|Baseline|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
10976043|NCT00938886|BG002|Baseline|Total|Total of all reporting groups
10976044|NCT00938886|FG000|Participant Flow|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
10976045|NCT00938886|FG001|Participant Flow|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
10976046|NCT00938886|OG000|Outcome|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
10976047|NCT00938886|OG001|Outcome|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
10976048|NCT00938886|EG000|Reported Event|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
10976049|NCT00938886|EG001|Reported Event|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
10976050|NCT00938964|BG000|Baseline|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
10976051|NCT00938964|BG001|Baseline|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
10976052|NCT00938964|BG002|Baseline|Total|Total of all reporting groups
10976053|NCT00938964|FG000|Participant Flow|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
10976054|NCT00938964|FG001|Participant Flow|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
10976055|NCT00938964|OG000|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
10976056|NCT00938964|OG001|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
10976057|NCT00938964|EG000|Reported Event|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
10976058|NCT00938964|EG001|Reported Event|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
10976059|NCT00939003|BG000|Baseline|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
10976060|NCT00939003|BG001|Baseline|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
10976061|NCT00939003|BG002|Baseline|Total|Total of all reporting groups
10976062|NCT00939003|FG000|Participant Flow|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
11222116|NCT02345226|EG003|Reported Event|Open-Label FTC/RPV/TAF From EFV/FTC/TDF|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the EFV/FTC/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
11222117|NCT02345252|BG000|Baseline|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
11222118|NCT02345252|BG001|Baseline|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
11222119|NCT02345252|BG002|Baseline|Total|Total of all reporting groups
10976063|NCT00939003|FG001|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
10976064|NCT00939003|OG000|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
10976065|NCT00939003|OG001|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
10976066|NCT00939003|OG000|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
10976067|NCT00939003|OG001|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
10976068|NCT00939003|EG000|Reported Event|Double-blind Placebo|Participants received placebo every other week for 12 weeks during the double-blind period.
10976069|NCT00939003|EG001|Reported Event|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period.
10976070|NCT00939003|EG002|Reported Event|Any Adalimumab|Participants who received any dose of adalimumab during the 12-week double-blind period or during the 144-week open-label period.
10976071|NCT00939029|BG000|Baseline|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
10976072|NCT00939029|BG001|Baseline|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
10976073|NCT00939029|BG002|Baseline|Total|Total of all reporting groups
10976074|NCT00939029|FG000|Participant Flow|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
10976075|NCT00939029|FG001|Participant Flow|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
10976076|NCT00939029|OG000|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
10976077|NCT00939029|OG001|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
10976078|NCT00939029|EG000|Reported Event|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
10976079|NCT00939029|EG001|Reported Event|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
10976080|NCT00939055|BG000|Baseline|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
10976081|NCT00939055|BG001|Baseline|Sham Procedure|"No intervention~Sham procedure: False procedure"
10976082|NCT00939055|BG002|Baseline|Total|Total of all reporting groups
10976083|NCT00939055|FG000|Participant Flow|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
10976084|NCT00939055|FG001|Participant Flow|Sham Procedure|"No intervention~Sham procedure: False procedure"
10976085|NCT00939055|OG000|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
10976086|NCT00939055|OG001|Outcome|Sham|No intervention
10976087|NCT00939055|OG001|Outcome|Sham Procedure|"No intervention~Sham procedure: False procedure"
10976088|NCT00939055|EG000|Reported Event|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
10976089|NCT00939055|EG001|Reported Event|Sham|No intervention
10976090|NCT00939094|BG000|Baseline|A - AZD2066|AZD2066, 12 mg capsule
10976091|NCT00939094|BG001|Baseline|2 - Placebo|Placebo, capsule
10976092|NCT00939094|BG002|Baseline|Total|Total of all reporting groups
10976093|NCT00939094|FG000|Participant Flow|A - AZD2066|AZD2066, 12 mg capsule
10976094|NCT00939094|FG001|Participant Flow|2 - Placebo|Placebo, capsule
10976095|NCT00939094|OG000|Outcome|A - AZD2066|AZD2066, 12 mg capsule
10976096|NCT00939094|OG001|Outcome|2 - Placebo|Placebo, capsule
10976097|NCT00939094|EG000|Reported Event|A - AZD2066|AZD2066, 12 mg capsule
10976098|NCT00939094|EG001|Reported Event|2 - Placebo|Placebo, capsule
10976099|NCT00939107|BG000|Baseline|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
10976100|NCT00939107|BG001|Baseline|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
10976101|NCT00939107|BG002|Baseline|Total|Total of all reporting groups
10976102|NCT00939107|FG000|Participant Flow|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
10976103|NCT00939107|FG001|Participant Flow|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
10976104|NCT00939107|OG000|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
10976105|NCT00939107|OG001|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
10976106|NCT00939107|EG000|Reported Event|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
11126274|NCT01648205|OG001|Outcome|Ranolazine at 6 Months|Ranolazine was administered for 5 months following 1 month on placebo.
11222120|NCT02345252|FG000|Participant Flow|FTC/RPV/TAF|"Double-Blind Phase: Emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) placebo tablet orally once daily for up to 96 weeks.~Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first."
11222121|NCT02345252|FG001|Participant Flow|FTC/RPV/TDF|"Double-Blind Phase: FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.~Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first."
11222122|NCT02345252|OG000|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
11222123|NCT02345252|OG001|Outcome|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
11222124|NCT02345252|EG000|Reported Event|FTC/RPV/TAF (Double-Blind Phase)|Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TAF group, who received FTC/RPV/TAF (200/25/25 mg) FDC tablet plus FTC/RPV/TDF placebo tablet administered orally once daily.
11222125|NCT02345252|EG001|Reported Event|FTC/RPV/TDF (Double-Blind Phase)|Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TDF group, who received FTC/RPV/TDF (200/25/300 mg) FDC tablet plus FTC/RPV/TAF placebo tablet administered orally once daily.
11222126|NCT02345252|EG002|Reported Event|Open-Label FTC/RPV/TAF From FTC/RPV/TAF|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the FTC/RPV/TAF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
11222127|NCT02345252|EG003|Reported Event|Open-Label FTC/RPV/TAF From FTC/RPV/TDF|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the FTC/RPV/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
11222128|NCT02345330|BG000|Baseline|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
11222129|NCT02345330|FG000|Participant Flow|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
10976107|NCT00939107|EG001|Reported Event|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
10976108|NCT00939120|BG000|Baseline|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
11222130|NCT02345330|OG000|Outcome|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
10976109|NCT00939120|BG001|Baseline|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
10976110|NCT00939120|BG002|Baseline|Total|Total of all reporting groups
10976111|NCT00939120|FG000|Participant Flow|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
11222131|NCT02345330|EG000|Reported Event|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
10976112|NCT00939120|FG001|Participant Flow|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
10976113|NCT00939120|OG000|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
10976114|NCT00939120|OG001|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
10976115|NCT00939120|EG000|Reported Event|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
10976116|NCT00939120|EG001|Reported Event|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
10976117|NCT00939159|BG000|Baseline|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
10976118|NCT00939159|FG000|Participant Flow|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
10976119|NCT00939159|OG000|Outcome|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
10976120|NCT00939159|EG000|Reported Event|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
10976121|NCT00939185|BG000|Baseline|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
10976122|NCT00939185|FG000|Participant Flow|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
10976123|NCT00939185|OG000|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
10976124|NCT00939185|EG000|Reported Event|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
10976125|NCT00939198|BG000|Baseline|Na-ASP-2 Hookworm Antigen Skin Test|All participants will be skin tested with Na-ASP-2 skin test reagent (1000 mcg/ml recombinant Na-ASP-2) applied to their arms, using both the prick-puncture and intradermal techniques.
10976126|NCT00939198|FG000|Participant Flow|Na-ASP-2 Hookworm Antigen Skin Test|All participants will be skin tested with Na-ASP-2 skin test reagent (1000 mcg/ml recombinant Na-ASP-2) applied to their arms, using both the prick-puncture and intradermal techniques.
10976127|NCT00939198|OG000|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"All participants will be skin tested with Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.~Na-ASP-2 Skin Test Reagent: Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution"
10976128|NCT00939198|OG000|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|All participants will be skin tested with Na-ASP-2 skin test reagent (1000 mcg/ml recombinant Na-ASP-2) applied to their arms, using both the prick-puncture and intradermal techniques.
10976129|NCT00939198|EG000|Reported Event|Na-ASP-2 Hookworm Antigen Skin Test|All participants will be skin tested with Na-ASP-2 skin test reagent (1000 mcg/ml recombinant Na-ASP-2) applied to their arms, using both the prick-puncture and intradermal techniques.
10976130|NCT00939211|BG000|Baseline|Overall Number of Baseline Participants|
10976131|NCT00939211|FG000|Participant Flow|Entire Study Population|
11222132|NCT02345434|BG000|Baseline|No Informative Letter|This is the control arm and it involves no contact with the prescriber
10976132|NCT00939211|OG000|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
10976133|NCT00939211|OG001|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
10976134|NCT00939211|OG002|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
10976135|NCT00939211|OG003|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
10976136|NCT00939211|OG004|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
10976137|NCT00939211|EG000|Reported Event|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
10976138|NCT00939211|EG001|Reported Event|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
10976139|NCT00939211|EG002|Reported Event|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
10976140|NCT00939211|EG003|Reported Event|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
10976141|NCT00939211|EG004|Reported Event|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
10976142|NCT00939341|BG000|Baseline|Symbicort Turbuhaler|160/4.5 µg delivered dose
10976143|NCT00939341|FG000|Participant Flow|Symbicort Turbuhaler|160/4.5 µg delivered dose
10976144|NCT00939341|OG000|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
10976145|NCT00939341|EG000|Reported Event|Symbicort Turbuhaler|160/4.5 µg delivered dose
10976146|NCT00939367|BG000|Baseline|All Study Participants|Torrent's Zolpidem Tartrate Tablets 10 mg and Ambien® 10mg tablets
10976147|NCT00939367|FG000|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
10976148|NCT00939367|FG001|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
10976149|NCT00939367|OG000|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
10976150|NCT00939367|OG001|Outcome|Active Comparator|Ambien® 10mg tablets
10976151|NCT00939367|EG000|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
10976152|NCT00939367|EG001|Reported Event|Active Comparator|Ambien® 10mg tablets
10976153|NCT00939393|BG000|Baseline|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
10976154|NCT00939393|BG001|Baseline|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
10976155|NCT00939393|BG002|Baseline|Total|Total of all reporting groups
10976156|NCT00939393|FG000|Participant Flow|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
10976157|NCT00939393|FG001|Participant Flow|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
10976158|NCT00939393|OG000|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
10976159|NCT00939393|OG001|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
10976160|NCT00939393|OG000|Outcome|In Office|Endoscopic sinus surgery (ESS) performed in physician's office (IO, or In Office) using balloon sinus dilation device.
10976161|NCT00939393|OG001|Outcome|Operating Room|Endoscopic sinus surgery (ESS) performed in the operating room (OR) with or without balloon sinus dilation devices.
10976162|NCT00939393|EG000|Reported Event|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
11222133|NCT02345434|BG001|Baseline|Informative Letter|"This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)~Informative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."
11222134|NCT02345434|BG002|Baseline|Total|Total of all reporting groups
11222135|NCT02345434|FG000|Participant Flow|No Informative Letter|This is the control arm and it involves no contact with the prescriber
11222136|NCT02345434|FG001|Participant Flow|Informative Letter|"This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)~Informative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."
11222137|NCT02345434|OG000|Outcome|No Informative Letter|This is the control arm and it involves no contact with the prescriber
11222138|NCT02345434|OG001|Outcome|Informative Letter|"This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)~Informative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."
11222139|NCT02345434|EG000|Reported Event|No Informative Letter|This is the control arm and it involves no contact with the prescriber
11222140|NCT02345434|EG001|Reported Event|Informative Letter|"This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)~Informative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."
10976163|NCT00939393|EG001|Reported Event|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
10976164|NCT00939471|BG000|Baseline|Balloon Device|Balloon catheter dilation of sinus ostia
10976165|NCT00939471|FG000|Participant Flow|Balloon Device|Balloon catheter dilation of sinus ostia
10976166|NCT00939471|OG000|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
10976167|NCT00939471|EG000|Reported Event|Balloon Device|Balloon catheter dilation of sinus ostia
10976168|NCT00939484|BG000|Baseline|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
10976169|NCT00939484|BG001|Baseline|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
10976170|NCT00939484|BG002|Baseline|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
11222141|NCT02345486|BG000|Baseline|0.9% Sodium Chloride|"Participants in the '0.9% sodium chloride' arm will receive 0.9% sodium chloride ('normal saline') any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.~0.9% sodium chloride"
11343677|NCT03921151|OG001|Outcome|Non-drug Using Healthy Controls|"Participants who are not drug users~Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment."
11343678|NCT03921151|EG000|Reported Event|Cocaine-dependent|"Participants who use and are dependent on cocaine~Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment."
10976171|NCT00939484|BG003|Baseline|Total|Total of all reporting groups
10976172|NCT00939484|FG000|Participant Flow|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
10976173|NCT00939484|FG001|Participant Flow|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
11222142|NCT02345486|BG001|Baseline|Physiologically Balanced Fluid|"Participants in the 'physiologically balanced fluid' arm will receive physiologically balanced fluid (Lactated ringers or Plasmalyte-A) any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.~Physiologically balanced fluid"
11222143|NCT02345486|BG002|Baseline|Total|Total of all reporting groups
11222144|NCT02345486|FG000|Participant Flow|0.9% Sodium Chloride|"Participants in the '0.9% sodium chloride' arm will receive 0.9% sodium chloride ('normal saline') any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.~0.9% sodium chloride"
11222145|NCT02345486|FG001|Participant Flow|Physiologically Balanced Fluid|"Participants in the 'physiologically balanced fluid' arm will receive physiologically balanced fluid (Lactated ringers or Plasmalyte-A) any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.~Physiologically balanced fluid"
10976174|NCT00939484|FG002|Participant Flow|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
10976175|NCT00939484|OG000|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
10976176|NCT00939484|OG001|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
10976177|NCT00939484|OG002|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
10976178|NCT00939484|OG000|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
10976179|NCT00939484|OG000|Outcome|PBTC025B|Adult patients with a histologically confirmed diagnosis of medulloblastoma (including posterior fossa PNET) that is recurrent, progressive, or refractory.
10976180|NCT00939484|EG000|Reported Event|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
10976181|NCT00939484|EG001|Reported Event|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
10976182|NCT00939484|EG002|Reported Event|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
10976183|NCT00939510|BG000|Baseline|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
10976184|NCT00939510|FG000|Participant Flow|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
10976185|NCT00939510|OG000|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
10976186|NCT00939510|EG000|Reported Event|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
10976187|NCT00939523|BG000|Baseline|Lapatinib|"All participants will be asked to take Lapatinib daily for a total of six months during the research study.~Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study."
10976188|NCT00939523|FG000|Participant Flow|Lapatinib|"All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.~Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study."
10976189|NCT00939523|OG000|Outcome|Lapatinib|"All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.~Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study."
10976190|NCT00939523|EG000|Reported Event|Lapatinib|"All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.~Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study."
10976191|NCT00939536|BG000|Baseline|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
10976192|NCT00939536|BG001|Baseline|Active Comparator|Ambien® 10mg tablets
10976193|NCT00939536|BG002|Baseline|Total|Total of all reporting groups
10976194|NCT00939536|FG000|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
10976195|NCT00939536|FG001|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
10976196|NCT00939536|OG000|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
10976197|NCT00939536|OG001|Outcome|Active Comparator|Ambien® 10mg tablets
10976198|NCT00939536|EG000|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
10976199|NCT00939536|EG001|Reported Event|Active Comparator|Ambien® 10mg tablets
10976200|NCT00939562|BG000|Baseline|Entire Study Population|Includes subjects who received a single dose of one 100 mg doxycycline monohydrate tablet (Test) and a single dose of one 100 mg doxycycline carragenate tablet (Reference).
10976201|NCT00939562|FG000|Participant Flow|Doxycycline Monohydrate, Then Doxycycline Carragenate|Single dose of one 100 mg doxycycline monohydrate tablet (Test) during first period and single dose of one 100 mg doxycycline carragenate tablet (Reference) during the second period.
10976202|NCT00939562|FG001|Participant Flow|Doxycycline Carragenate, Then Doxycycline Monohydrate|Single dose of one 100 mg doxycycline carragenate tablet (Reference) during first period and single dose of one 100 mg doxycycline monohydrate tablet (Test) during the second period.
10976203|NCT00939562|OG000|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
10976204|NCT00939562|OG001|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
10976205|NCT00939562|EG000|Reported Event|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
10976206|NCT00939562|EG001|Reported Event|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
10976207|NCT00939627|BG000|Baseline|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
10976208|NCT00939627|BG001|Baseline|Arm B - Cetuximab and Sorafenib Tosylate|Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
10976209|NCT00939627|BG002|Baseline|Total|Total of all reporting groups
10976210|NCT00939627|FG000|Participant Flow|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility..
10976211|NCT00939627|FG001|Participant Flow|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
10976212|NCT00939627|FG002|Participant Flow|Participants Who Did Not Receive Treatment.|Placebo Arm: The protocol was amended and this arm was removed.
10976213|NCT00939627|OG000|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
10976214|NCT00939627|OG001|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
10976215|NCT00939627|EG000|Reported Event|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
10976216|NCT00939627|EG001|Reported Event|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
10976217|NCT00939640|BG000|Baseline|Dietary Intervention|"Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.~DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured."
10976218|NCT00939640|FG000|Participant Flow|Dietary Intervention|"Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.~DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured."
10976219|NCT00939640|OG000|Outcome|Pre-dietary Intervention|"Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.~DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured."
10976220|NCT00939640|OG001|Outcome|Post-dietary Intervention|
10976221|NCT00939640|OG000|Outcome|Pre-Dietary Intervention|"Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.~DASH/sodium-restricted diet (SRD): Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured."
10976222|NCT00939640|OG001|Outcome|Post-dietary Intervention|Post-dietary intervention
10976223|NCT00939640|OG001|Outcome|Post-Dietary Intervention|
11007018|NCT01089062|FG002|Participant Flow|Treatment B, Then A, Then C|"The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
10976224|NCT00939640|OG000|Outcome|Pre-Dietary Intervention|"Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.~DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured."
11007019|NCT01089062|FG003|Participant Flow|Treatment B, Then C, Then A|"The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
11222146|NCT02345486|OG000|Outcome|0.9% Sodium Chloride|"Participants in the '0.9% sodium chloride' arm will receive 0.9% sodium chloride ('normal saline') any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.~0.9% sodium chloride"
11222147|NCT02345486|OG001|Outcome|Physiologically Balanced Fluid|"Participants in the 'physiologically balanced fluid' arm will receive physiologically balanced fluid (Lactated ringers or Plasmalyte-A) any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.~Physiologically balanced fluid"
11222148|NCT02345486|EG000|Reported Event|0.9% Sodium Chloride|"Participants in the '0.9% sodium chloride' arm will receive 0.9% sodium chloride ('normal saline') any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.~0.9% sodium chloride"
11222149|NCT02345486|EG001|Reported Event|Physiologically Balanced Fluid|"Participants in the 'physiologically balanced fluid' arm will receive physiologically balanced fluid (Lactated ringers or Plasmalyte-A) any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.~Physiologically balanced fluid"
11222150|NCT02345512|BG000|Baseline|Lycra Splint|"Wearing of Lycra splinting garment~Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks"
11222151|NCT02345512|FG000|Participant Flow|Lycra Splint|"Wearing of Lycra splinting garment~Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks"
11222152|NCT02345512|OG000|Outcome|All Participants|All participants (no subgroups or arm)
11222153|NCT02345512|OG000|Outcome|Baseline|All participants at baseline
11222154|NCT02345512|OG001|Outcome|Post Intervention|All participants post intervention
11222155|NCT02345512|OG000|Outcome|Basline|All participants at baseline
11222156|NCT02345512|OG001|Outcome|Post Intervention|All participants post intervention.
11222157|NCT02345512|OG000|Outcome|All Participants|All participants together as no subgroups or arms
11222158|NCT02345512|EG000|Reported Event|Lycra Splint|"Wearing of Lycra splinting garment~Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks"
11222159|NCT02345642|BG000|Baseline|10 Healthy Patients Without THA|"The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
11222160|NCT02345642|BG001|Baseline|10 Patients With THA on Post-Op Day 2|"The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
11222161|NCT02345642|BG002|Baseline|Total|Total of all reporting groups
11222162|NCT02345642|FG000|Participant Flow|10 Healthy Patients Without THA|"The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them. A randomization technique was used to determine laterality and sequence of study events.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
11222163|NCT02345642|FG001|Participant Flow|10 Patients With THA on Post-Op Day 2|"The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
11222164|NCT02345642|OG000|Outcome|10 Healthy Patients Without THA|"The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
11222165|NCT02345642|OG001|Outcome|10 Patients With THA on Post-Op Day 2|"The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
11222166|NCT02345642|EG000|Reported Event|10 Healthy Patients Without THA|"The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
11222167|NCT02345642|EG001|Reported Event|10 Patients With THA on Post-Op Day 2|"The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
11222168|NCT02345720|BG000|Baseline|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
11222169|NCT02345720|FG000|Participant Flow|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
11222170|NCT02345720|OG000|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
10976225|NCT00939640|EG000|Reported Event|Dietary Intervention|"Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.~DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured."
10976226|NCT00939653|BG000|Baseline|Enrolled Patients|Baseline measures were collected for all enrolled patients.
10976227|NCT00939653|FG000|Participant Flow|Single Arm - Protocol Chemo Regimen|"All patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim.~clofarabine: 40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5.~etoposide: 100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5.~cyclophosphamide: 440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5.~filgrastim: 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is > 1000 x 2 days.~cytarabine: Given intrathecally on day 1 at the dose defined by age below. 30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients >3 years of age"
10976228|NCT00939653|OG000|Outcome|Enrolled Patients|All patient that completed at least 1 treatment course.
10976229|NCT00939653|OG000|Outcome|Enrolled Patients|All patients enrolled onto study.
10976230|NCT00939653|EG000|Reported Event|Enrolled Patients|All patients enrolled onto study.
10976231|NCT00939692|BG000|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
10976232|NCT00939692|BG001|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
10976233|NCT00939692|BG002|Baseline|Total|Total of all reporting groups
10976234|NCT00939692|FG000|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
10976235|NCT00939692|FG001|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
10976236|NCT00939692|OG000|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
10976237|NCT00939692|OG001|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
10976238|NCT00939692|EG000|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
10976239|NCT00939692|EG001|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
10976240|NCT00939705|BG000|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
10976241|NCT00939705|BG001|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
10976242|NCT00939705|BG002|Baseline|Total|Total of all reporting groups
10976243|NCT00939705|FG000|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
10976244|NCT00939705|FG001|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
10976245|NCT00939705|OG000|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
10976246|NCT00939705|OG001|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
10976247|NCT00939705|EG000|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
10976248|NCT00939705|EG001|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
10976249|NCT00939731|BG000|Baseline|Entire Study Population|Includes participants randomized to receive PF-02341066 250 mg IRT first and PF-02341066 250 mg PIC first.
10976250|NCT00939731|FG000|Participant Flow|PF-02341066 250 mg IRT First, Then PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg immediate release tablet (IRT) in first intervention period; and single oral dose of PF-02341066 250 mg powder in capsule (PIC) in second intervention period. A washout period of at least 14 days was maintained between each period.
10976251|NCT00939731|FG001|Participant Flow|PF-02341066 250 mg PIC First, Then PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg PIC in first intervention period; and single oral dose of PF-02341066 250 mg IRT in second intervention period. A washout period of at least 14 days was maintained between each period.
10976252|NCT00939731|OG000|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
10976253|NCT00939731|OG001|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
10976254|NCT00939731|EG000|Reported Event|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
11222171|NCT02345720|EG000|Reported Event|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
11222172|NCT02345811|BG000|Baseline|Overall Study|"Subjects were randomized to wear either the test lens or the control lens for 2 weeks and then cross-over to the other lens.~Test Lens: Sapphire (contact lens) Control Lens : Senofilcon A (contact lens)"
11222173|NCT02345811|FG000|Participant Flow|Sapphire Lens Then Senofilcon A|"Participants were randomized to wear the Sapphire lens pair for two weeks then cross over to Senofilcon A pair for two weeks.~Sapphire Lens: silicone-hydrogel contact lens senofilcon A: contact lens"
11222174|NCT02345811|FG001|Participant Flow|Senofilcon A Then Sapphire Lens|"Participants were randomized to wear the senofilcon A lens pair for two weeks then cross over to Sapphire lens pair for two weeks.~senofilcon A: contact lens Sapphire lens: silicone-hydrogel contact lens"
11222175|NCT02345811|OG000|Outcome|Sapphire|"Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.~Sapphire: silicone-hydrogel contact lens"
11222176|NCT02345811|OG001|Outcome|Senofilcon A|"Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.~senofilcon A: contact lens"
11222177|NCT02345811|OG000|Outcome|Sapphire|"Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.~Sapphire Lens: silicone-hydrogel contact lens"
11222178|NCT02345811|OG000|Outcome|Overall Study|"Participants were randomized to wear the Sapphire lens pair for two weeks and senofilcon A lens pair for two weeks during the cross over study.~Sapphire: silicone-hydrogel contact lens senofilcon A: silicone-hydrogel contact lens"
11222179|NCT02345811|EG000|Reported Event|Sapphire|"Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.~Sapphire: silicone-hydrogel contact lens"
11222180|NCT02345811|EG001|Reported Event|Senofilcon A|"Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.~senofilcon A: contact lens"
10854963|NCT00325819|FG001|Participant Flow|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
10854964|NCT00325819|OG000|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
10854965|NCT00325819|OG001|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
11222181|NCT02345889|BG000|Baseline|Standard Colonoscopy|"A standard colonoscope will be used to complete the procedure~Standard Colonoscopy: Current standard of care colonoscopy"
11222182|NCT02345889|BG001|Baseline|Colonoscopy With EndoCuff™|"An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope~Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope"
11222183|NCT02345889|BG002|Baseline|Colonoscopy With EndoRings™|"An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope~Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope"
11222184|NCT02345889|BG003|Baseline|FUSE® Colonoscopy|"A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy~FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system"
11222185|NCT02345889|BG004|Baseline|Total|Total of all reporting groups
11222186|NCT02345889|FG000|Participant Flow|Standard Colonoscopy|"A standard colonoscope will be used to complete the procedure~Standard Colonoscopy: Current standard of care colonoscopy"
11222187|NCT02345889|FG001|Participant Flow|Colonoscopy With EndoCuff™|"An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope~Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope"
11222188|NCT02345889|FG002|Participant Flow|Colonoscopy With EndoRings™|"An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope~Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope"
11222189|NCT02345889|FG003|Participant Flow|FUSE® Colonoscopy|"A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy~FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system"
11222190|NCT02345889|OG000|Outcome|Standard Colonoscopy|"A standard colonoscope will be used to complete the procedure~Standard Colonoscopy: Current standard of care colonoscopy"
11222191|NCT02345889|OG001|Outcome|Colonoscopy With EndoCuff™|"An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope~Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope"
11222192|NCT02345889|OG002|Outcome|Colonoscopy With EndoRings™|"An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope~Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope"
11222193|NCT02345889|OG003|Outcome|FUSE® Colonoscopy|"A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy~FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system"
11222194|NCT02345889|EG000|Reported Event|Standard Colonoscopy|"A standard colonoscope will be used to complete the procedure~Standard Colonoscopy: Current standard of care colonoscopy"
11222195|NCT02345889|EG001|Reported Event|Colonoscopy With EndoCuff™|"An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope~Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope"
10976255|NCT00939731|EG001|Reported Event|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
11222196|NCT02345889|EG002|Reported Event|Colonoscopy With EndoRings™|"An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope~Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope"
11222197|NCT02345889|EG003|Reported Event|FUSE® Colonoscopy|"A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy~FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system"
11336364|NCT03565315|OG002|Outcome|Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11343679|NCT03921151|EG001|Reported Event|Non-drug Using Healthy Controls|"Participants who are not drug users~Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment."
10854966|NCT00325819|OG000|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
10854967|NCT00325819|OG001|Outcome|Placebo|Subjects who were randomized to receive placebo
10854968|NCT00325819|EG000|Reported Event|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
10854969|NCT00325819|EG001|Reported Event|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
10854970|NCT00325897|BG000|Baseline|Azithromycin|Azithromycin, 250 mg
10854971|NCT00325897|BG001|Baseline|Placebo|Inactive sugar pill
10854972|NCT00325897|BG002|Baseline|Total|Total of all reporting groups
10854973|NCT00325897|FG000|Participant Flow|Azithromycin|Azithromycin, 250 mg
10854974|NCT00325897|FG001|Participant Flow|Placebo|Inactive sugar pill
10854975|NCT00325897|OG000|Outcome|Azithromycin|Azithromycin 250 mg
10854976|NCT00325897|OG001|Outcome|Placebo|Inactive sugar pill
10854977|NCT00325897|OG000|Outcome|Azithromycin|Azithromycin, 250 mg
10854978|NCT00325897|OG000|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
10854979|NCT00325897|OG001|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
10854980|NCT00325897|EG000|Reported Event|Azithromycin|Azithromycin, 250 mg
10854981|NCT00325897|EG001|Reported Event|Placebo|Inactive sugar pill
10854982|NCT00326001|BG000|Baseline|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
10854983|NCT00326001|BG001|Baseline|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
10854984|NCT00326001|BG002|Baseline|Total|Total of all reporting groups
10854985|NCT00326001|FG000|Participant Flow|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
10854986|NCT00326001|FG001|Participant Flow|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
10854987|NCT00326001|OG000|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
10854988|NCT00326001|OG001|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
10854989|NCT00326001|EG000|Reported Event|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
10854990|NCT00326001|EG001|Reported Event|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
10854991|NCT00326118|BG000|Baseline|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
10854992|NCT00326118|BG001|Baseline|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
10854993|NCT00326118|BG002|Baseline|Total|Total of all reporting groups
10854994|NCT00326118|FG000|Participant Flow|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
11222198|NCT02346136|BG000|Baseline|Tai Chi|"This arm will receive a 6-month Tai Chi training intervention. Tai Chi training will include gentle dynamic stretching and strengthening, slow integrated movements, efficient posture, heightened body awareness and inner focus, active relaxation of body and mind, mindful diaphragmatic breathing, and healing imagery and intention. Participants will be asked to complete two formal group classes each week for at least 6 months, led by senior Tai Chi instructors. Additionally, participants will be given practice DVDs (and DVD players if necessary) and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week.~Tai Chi training"
11222199|NCT02346136|BG001|Baseline|Educational Control|"This arm will receive a 6-month educational control intervention. Participants will attend monthly educational group sessions within a common area of each housing facility. Sessions will be led by research personnel and include material from Patient Education Forms (PEFs) produced by the American Geriatric Society. Sessions will be semi-structured and contain approximately 30 minutes of lecture and 30 minutes of group discussion.~Educational Control"
11222200|NCT02346136|BG002|Baseline|Total|Total of all reporting groups
11222201|NCT02346136|FG000|Participant Flow|Tai Chi|"This arm will receive a 6-month Tai Chi training intervention. Tai Chi training will include gentle dynamic stretching and strengthening, slow integrated movements, efficient posture, heightened body awareness and inner focus, active relaxation of body and mind, mindful diaphragmatic breathing, and healing imagery and intention. Participants will be asked to complete two formal group classes each week for at least 6 months, led by senior Tai Chi instructors. Additionally, participants will be given practice Digital Versatile Disc (DVD), DVD players if necessary, and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week.~Tai Chi training"
11222202|NCT02346136|FG001|Participant Flow|Educational Control|"This arm will receive a 6-month educational control intervention. Participants will attend monthly educational group sessions within a common area of each housing facility. Sessions will be led by research personnel and include material from Patient Education Forms (PEFs) produced by the American Geriatric Society. Sessions will be semi-structured and contain approximately 30 minutes of lecture and 30 minutes of group discussion.~Educational Control"
11222203|NCT02346136|OG000|Outcome|Tai Chi|"This arm will receive a 6-month Tai Chi training intervention. Tai Chi training will include gentle dynamic stretching and strengthening, slow integrated movements, efficient posture, heightened body awareness and inner focus, active relaxation of body and mind, mindful diaphragmatic breathing, and healing imagery and intention. Participants will be asked to complete two formal group classes each week for at least 6 months, led by senior Tai Chi instructors. Additionally, participants will be given practice DVDs (and DVD players if necessary) and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week.~Tai Chi training"
11222204|NCT02346136|OG001|Outcome|Educational Control|"This arm will receive a 6-month educational control intervention. Participants will attend monthly educational group sessions within a common area of each housing facility. Sessions will be led by research personnel and include material from Patient Education Forms (PEFs) produced by the American Geriatric Society. Sessions will be semi-structured and contain approximately 30 minutes of lecture and 30 minutes of group discussion.~Educational Control"
11222205|NCT02346136|EG000|Reported Event|Tai Chi|"This arm will receive a 6-month Tai Chi training intervention. Tai Chi training will include gentle dynamic stretching and strengthening, slow integrated movements, efficient posture, heightened body awareness and inner focus, active relaxation of body and mind, mindful diaphragmatic breathing, and healing imagery and intention. Participants will be asked to complete two formal group classes each week for at least 6 months, led by senior Tai Chi instructors. Additionally, participants will be given practice DVDs (and DVD players if necessary) and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week.~Tai Chi training"
10854995|NCT00326118|FG001|Participant Flow|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
10854996|NCT00326118|OG000|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
11222206|NCT02346136|EG001|Reported Event|Educational Control|"This arm will receive a 6-month educational control intervention. Participants will attend monthly educational group sessions within a common area of each housing facility. Sessions will be led by research personnel and include material from Patient Education Forms (PEFs) produced by the American Geriatric Society. Sessions will be semi-structured and contain approximately 30 minutes of lecture and 30 minutes of group discussion.~Educational Control"
11222207|NCT02346240|BG000|Baseline|Placebo Q2W|"Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions."
11222208|NCT02346240|BG001|Baseline|Etanercept|"Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5.~•PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions."
11222209|NCT02346240|BG002|Baseline|CZP 200 mg Q2W|"CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions."
11222210|NCT02346240|BG003|Baseline|CZP 400 mg Q2W|"CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions."
11222211|NCT02346240|BG004|Baseline|Total Title|
11222212|NCT02346240|FG000|Participant Flow|Placebo Q2W|"Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions."
11222213|NCT02346240|FG001|Participant Flow|Etanercept|"Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5.~•PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions."
11222214|NCT02346240|FG002|Participant Flow|CZP 200 mg Q2W|"CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions."
11222215|NCT02346240|FG003|Participant Flow|CZP 400 mg Q2W|"CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions."
11222216|NCT02346240|FG004|Participant Flow|Placebo/Placebo Q2W|This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).
11222217|NCT02346240|FG005|Participant Flow|Etanercept/Placebo Q2W|This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).
11222218|NCT02346240|FG006|Participant Flow|Etanercept/CZP 200 mg Q2W|This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).
11222219|NCT02346240|FG007|Participant Flow|CZP 200 mg Q2W/Placebo Q2W|This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).
11222220|NCT02346240|FG008|Participant Flow|CZP 200 mg Q2W/CZP 200 mg Q2W|This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).
11222221|NCT02346240|FG009|Participant Flow|CZP 200 mg Q2W/CZP 400 mg Q4W|This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48).
11222222|NCT02346240|FG010|Participant Flow|CZP 400 mg Q2W/Placebo Q2W|This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).
11222223|NCT02346240|FG011|Participant Flow|CZP 400 mg Q2W/CZP 200 mg Q2W|This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).
11222224|NCT02346240|FG012|Participant Flow|CZP 400 mg Q2W/CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48).
11222225|NCT02346240|FG013|Participant Flow|Placebo Q2W/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11222226|NCT02346240|FG014|Participant Flow|Etanercept/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the Etanercept arm, who did not achieve a PASI75 response at Week 16 escaped from the treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11222227|NCT02346240|FG015|Participant Flow|CZP 200 mg Q2W/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 200 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11222228|NCT02346240|FG016|Participant Flow|CZP 400 mg Q2W/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 400 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11222229|NCT02346240|FG017|Participant Flow|Placebo/CZP 200 mg Q2W OLE|This arm consisted of participants from the Placebo-controlled Maintenance Period, who achieved PASI50 response (had no relapse) at Week 48 and entered the 96-Weeks OLE Period receiving CZP 200 mg Q2W.
11222230|NCT02346240|FG018|Participant Flow|CZP 200 mg Q2W/CZP 200 mg Q2W OLE|This arm consisted of participants who received CZP 200 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE.
11222231|NCT02346240|FG019|Participant Flow|CZP 400 mg Q4W/CZP 200 mg Q2W OLE|This arm consisted of participants who received CZP 400 mg Q4W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose.
11222232|NCT02346240|FG020|Participant Flow|CZP 400 mg Q2W/CZP 200 mg Q2W OLE|This arm consisted of participants who received CZP 400 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose.
11222233|NCT02346240|FG021|Participant Flow|Esc CZP 400 mg Q2W/CZP 400 mg Q2W OLE|This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.
11222234|NCT02346240|FG022|Participant Flow|Placebo/CZP 400 mg Q2W OLE|This arm consisted of participants from the Placebo-controlled Maintenance Period, who did not achieve PASI50 response (had relapse) and entered the 96-weeks OLE Period receiving CZP 400 mg Q2W.
11222235|NCT02346240|FG023|Participant Flow|Any CZP/CZP 400 mg Q2W OLE|This arm consisted of participants who relapsed on CZP 200 mg Q2W, CZP 400 mg Q4W and 400 mg Q2W.
11222236|NCT02346240|OG000|Outcome|Placebo Q2W (RS)|"Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.~Participants formed the Randomized Set (RS)."
11222237|NCT02346240|OG001|Outcome|Etanercept (RS)|"Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5.~•PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.~Participants formed the Randomized Set (RS)."
10848797|NCT00291577|EG000|Reported Event|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
11222238|NCT02346240|OG002|Outcome|CZP 200 mg Q2W (RS)|"CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.~Participants formed the Randomized Set (RS)."
11222239|NCT02346240|OG003|Outcome|CZP 400 mg Q2W (RS)|"CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.~Participants formed the Randomized Set (RS)."
11343680|NCT03926039|BG000|Baseline|Sharing Decision-making Program Interventions|"Description of conventional traditional treatment options and add sharing decision-making program The intervention measures in this study sharing decision-making plan mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process.~sharing decision-making program: Sharing decision-making talks and decision-making assistance tools used in the process"
11222240|NCT02346240|OG001|Outcome|CZP 200 mg Q2W (RS)|"CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.~Participants formed the Randomized Set (RS)."
11222241|NCT02346240|OG002|Outcome|CZP 400 mg Q2W (RS)|"CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:~•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.~Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.~Participants formed the Randomized Set (RS)."
11343681|NCT03926039|BG001|Baseline|Description of Traditional Treatment Options|Description of conventional traditional treatment options
10976256|NCT00939770|BG000|Baseline|Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976257|NCT00939770|BG001|Baseline|Phase 1:Part A: PF-02341066 130 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976258|NCT00939770|BG002|Baseline|Phase 1:Part A: PF-02341066 165 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976259|NCT00939770|BG003|Baseline|Phase 1:Part A: PF-02341066 215 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976260|NCT00939770|BG004|Baseline|Phase 1: Part A: PF-02341066 280 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976261|NCT00939770|BG005|Baseline|Phase 1: Part A: PF-02341066 365 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976262|NCT00939770|BG006|Baseline|Phase 2: Part B: PF-02341066 280 mg/m²/Dose BID|Part B: Patients with ALK+ relapsed/refractory neuroblastoma
10976263|NCT00939770|BG007|Baseline|Phase 2: Part C: PF-02341066 280 mg/m²/Dose BID|Part C: Patients with ALK+ relapsed/refractory ALCL
10976264|NCT00939770|BG008|Baseline|Total|Total of all reporting groups
11343682|NCT03926039|BG002|Baseline|Total|Total of all reporting groups
10976265|NCT00939770|FG000|Participant Flow|Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976266|NCT00939770|FG001|Participant Flow|Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10854997|NCT00326118|OG001|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
11222242|NCT02346240|OG000|Outcome|Placebo/Placebo Q2W (WK16RS)|This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
10854998|NCT00326118|OG001|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm
10854999|NCT00326118|EG000|Reported Event|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
10855000|NCT00326118|EG001|Reported Event|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
10855001|NCT00326170|BG000|Baseline|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
10855002|NCT00326170|FG000|Participant Flow|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
10855003|NCT00326170|OG000|Outcome|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
10855004|NCT00326170|EG000|Reported Event|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
10855005|NCT00326196|BG000|Baseline|Percutaneous Coronary Intervention|Percutaneous coronary intervention
10855006|NCT00326196|BG001|Baseline|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
10855007|NCT00326196|BG002|Baseline|Total|Total of all reporting groups
10855008|NCT00326196|FG000|Participant Flow|Percutaneous Coronary Intervention|"Initial revascularization with Percutaneous coronary intervention. Whenever possible, drug-eluting stents will be used in the percutaneous treatment. The use of multiple stents to achieve a complete revascularization will be encouraged in the PCI treatment"
10855009|NCT00326196|FG001|Participant Flow|Coronary Artery Bypass Graft|Initial revascularization with Coronary artery bypass graft (CABG). Multiple arterial conduits for suitable target vessels will be encouraged in the surgical treatment.
10855010|NCT00326196|OG000|Outcome|Percutaneous Coronary Intervention|Percutaneous coronary intervention
10855011|NCT00326196|OG001|Outcome|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
10855012|NCT00326196|EG000|Reported Event|Percutaneous Coronary Intervention|Percutaneous coronary intervention
10855013|NCT00326196|EG001|Reported Event|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
10855014|NCT00326209|BG000|Baseline|Encapsulated Mesalamine Granules (eMG)|Participants received eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months.
10855015|NCT00326209|FG000|Participant Flow|Encapsulated Mesalamine Granules (eMG)|Participants received eMG 1.5 grams (4 capsules of eMG 0.375 grams each) once daily (QD) orally in the morning for up to 24 months.
10855016|NCT00326209|OG000|Outcome|Encapsulated Mesalamine Granules (eMG)|Participants received eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months.
10855017|NCT00326209|EG000|Reported Event|Encapsulated Mesalamine Granules (eMG)|Participants received eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months.
10855018|NCT00326417|BG000|Baseline|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
10855019|NCT00326417|BG001|Baseline|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
10855020|NCT00326417|BG002|Baseline|Total|Total of all reporting groups
10855021|NCT00326417|FG000|Participant Flow|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
10855022|NCT00326417|FG001|Participant Flow|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
10855023|NCT00326417|FG002|Participant Flow|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
10855024|NCT00326417|FG003|Participant Flow|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
10855025|NCT00326417|OG000|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
10855026|NCT00326417|OG001|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
10855027|NCT00326417|EG000|Reported Event|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
10855028|NCT00326417|EG001|Reported Event|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
10855029|NCT00326417|EG002|Reported Event|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
10855030|NCT00326417|EG003|Reported Event|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
11222243|NCT02346240|OG001|Outcome|Etanercept/Placebo Q2W (WK16RS)|This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
11222244|NCT02346240|OG002|Outcome|Etanercept/CZP 200 mg Q2W (WK16RS)|This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
11222245|NCT02346240|OG003|Outcome|CZP 200 mg Q2W/Placebo Q2W (WK16RS)|This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
11222246|NCT02346240|OG004|Outcome|CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS)|This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
11222247|NCT02346240|OG005|Outcome|CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS)|This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
11222248|NCT02346240|OG006|Outcome|CZP 400 mg Q2W/Placebo Q2W (WK16RS)|This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
11222249|NCT02346240|OG007|Outcome|CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS)|This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
11222250|NCT02346240|OG008|Outcome|CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS)|This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
11222251|NCT02346240|EG000|Reported Event|Placebo Q2W (SS) Wk 0-48|"This arm consisted of all participants who received Placebo (PBO) at any time in the study (Week 0 to Week 48).~Only 2 participants received PBO from Week 16 to Week 48. Participants formed the Safety Set (SS)."
11222252|NCT02346240|EG001|Reported Event|Etanercept (SS) Wk 0-12|"This arm consisted of all participants who received Etanercept at any time in the study (Week 0 to Week 12).~Participants formed the SS."
11222253|NCT02346240|EG002|Reported Event|CZP 200 mg Q2W (SS) Wk 0-144|"This arm consisted of all participants who received CZP 200 mg Q2W at any time in the study (Week 0 to Week 144).~Participants formed the SS."
11222254|NCT02346240|EG003|Reported Event|CZP 400 mg Q2W (SS) Wk 0-144|"This arm consisted of all participants who received CZP 400 mg Q2W at any time in the study (Week 0 to Week 144).~Participants formed the SS."
11222255|NCT02346240|EG004|Reported Event|CZP 400mg Q4W (SS) Wk 16-48|"This arm consisted of all participants who received CZP 400 mg Q4W at any time in the study (Week 16 to Week 48).~Participants formed the SS."
11222256|NCT02346370|BG000|Baseline|Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel|1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222257|NCT02346370|BG001|Baseline|Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel|3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222258|NCT02346370|BG002|Baseline|Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel|2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222259|NCT02346370|BG003|Baseline|Total|Total of all reporting groups
11222260|NCT02346370|FG000|Participant Flow|Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel|1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222261|NCT02346370|FG001|Participant Flow|Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel|3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222262|NCT02346370|FG002|Participant Flow|Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel|2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222263|NCT02346370|OG000|Outcome|Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel|1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222264|NCT02346370|OG001|Outcome|Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel|3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
10976267|NCT00939770|FG002|Participant Flow|Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976268|NCT00939770|FG003|Participant Flow|Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976269|NCT00939770|FG004|Participant Flow|Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976270|NCT00939770|FG005|Participant Flow|Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976271|NCT00939770|FG006|Participant Flow|Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID|Part B: Patients with ALK+ relapsed/refractory neuroblastoma
10976272|NCT00939770|FG007|Participant Flow|Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID|Part C: Patients with ALK+ relapsed/refractory ALCL
10976273|NCT00939770|OG000|Outcome|Part A|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976274|NCT00939770|OG000|Outcome|Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976275|NCT00939770|OG001|Outcome|Phase 1: Part A:PF-02341066 130 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976276|NCT00939770|OG002|Outcome|Phase 1: Part A:PF-02341066 165 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976277|NCT00939770|OG003|Outcome|Phase 1: Part A:PF-02341066 215 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
11222265|NCT02346370|OG002|Outcome|Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel|2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
10848798|NCT00291642|BG000|Baseline|Placebo (PBO)|A single dose of placebo was administered orally on Day 1.
10848799|NCT00291642|BG001|Baseline|Levocetirizine (LCTZ) 2.5 mg|A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
10848800|NCT00291642|BG002|Baseline|Levocetirizine (LCTZ) 5 mg|A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
11222266|NCT02346370|OG000|Outcome|Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel|1.6 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222267|NCT02346370|OG000|Outcome|PEGPH20 + Docetaxel|PEGPH20 (1.6, 3.0, or 2.2 ug/kg) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
10848801|NCT00291642|BG003|Baseline|Cetirizine (CTZ) 5 mg|A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
10976278|NCT00939770|OG004|Outcome|Phase 1: Part A:PF-02341066 280 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976279|NCT00939770|OG005|Outcome|Phase 1: Part A: PF-02341066 365 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976280|NCT00939770|OG006|Outcome|Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID|Part B: Patients with ALK+ relapsed/refractory neuroblastoma
10976281|NCT00939770|OG007|Outcome|Phase 2:Part C: PF-02341066 280 mg/m2/Dose BID|Part C: Patients with ALK+ relapsed/refractory ALCL
10976282|NCT00939770|OG000|Outcome|Dose Level 3|PF-02341066 165 mg/m²/dose BID
10976283|NCT00939770|OG001|Outcome|Dose Level 4|PF-02341066 215 mg/m²/dose BID
10976284|NCT00939770|OG002|Outcome|Dose Level 5|PF-02341066 280 mg/m²/dose BID
10976285|NCT00939770|OG003|Outcome|Dose Level 6|PF-02341066 365 mg/m²/dose BID
10976286|NCT00939770|OG001|Outcome|Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976287|NCT00939770|OG002|Outcome|Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976288|NCT00939770|OG003|Outcome|Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976289|NCT00939770|OG004|Outcome|Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976290|NCT00939770|OG005|Outcome|Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976291|NCT00939770|OG000|Outcome|Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID|Part B: Patients with ALK+ relapsed/refractory neuroblastoma
10976292|NCT00939770|OG001|Outcome|Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID|Part C: Patients with ALK+ relapsed/refractory ALCL
10976293|NCT00939770|OG007|Outcome|Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID|Part C: Patients with ALK+ relapsed/refractory ALCL
11126275|NCT01648205|EG000|Reported Event|Ranolazine|"During 5 months on ranolazine following adverse events were reported:~Ventricular fibrillation successfully treated with shock from implantable cardioverter-defibrillator (n=1) Ventricular fibrillation unsuccessfully treated with shock from implantable cardioverter-defibrillator with subsequent death (n=1) Bundle branch block (n=1) Dizziness/unsteadiness (n=3) Headache (n=1) Constipation (n=1) Hematuria (n=1) Hemorrhoids (n=1)"
11343683|NCT03926039|FG000|Participant Flow|Sharing Decision-making Program Interventions|"Description of conventional traditional treatment options and add sharing decision-making program The intervention measures in this study sharing decision-making plan mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process.~sharing decision-making program: Sharing decision-making talks and decision-making assistance tools used in the process"
10976294|NCT00939770|EG000|Reported Event|Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976295|NCT00939770|EG001|Reported Event|Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976296|NCT00939770|EG002|Reported Event|Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976297|NCT00939770|EG003|Reported Event|Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976298|NCT00939770|EG004|Reported Event|Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976299|NCT00939770|EG005|Reported Event|Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID|Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
10976300|NCT00939770|EG006|Reported Event|Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID|Part B: Patients with ALK+ relapsed/refractory neuroblastoma
10976301|NCT00939770|EG007|Reported Event|Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID|Part C: Patients with ALK+ relapsed/refractory ALCL
10976302|NCT00939783|BG000|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
10976303|NCT00939783|FG000|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
10976304|NCT00939783|OG000|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
10976305|NCT00939783|EG000|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
10976306|NCT00939796|BG000|Baseline|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
10976307|NCT00939796|FG000|Participant Flow|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
10976308|NCT00939796|OG000|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
10976309|NCT00939796|EG000|Reported Event|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
10976310|NCT00939809|BG000|Baseline|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10976311|NCT00939809|FG000|Participant Flow|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10976312|NCT00939809|OG000|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
11343684|NCT03926039|FG001|Participant Flow|Description of Traditional Treatment Options|Description of conventional traditional treatment options
11222268|NCT02346370|EG000|Reported Event|Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel|1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222269|NCT02346370|EG001|Reported Event|Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel|3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222270|NCT02346370|EG002|Reported Event|Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel|2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
11222271|NCT02346383|BG000|Baseline|All Study Participants|Participants were randomized to 1 of 3 programs. Data were collected every 2 weeks at the completion of each program. Participants chose their preferred program from the previous 3 for the next 12 weeks.
11222272|NCT02346383|FG000|Participant Flow|All Study Participants|Participants were randomized to 1 of 3 programs. Data were collected every 2 weeks at the completion of each program. Participants chose their preferred program from the previous 3 for the next 12 weeks.
11222273|NCT02346383|OG000|Outcome|Program 1|"preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs~preset program: Change to different present program using epidural and peripheral lead to cover pain"
11222274|NCT02346383|OG001|Outcome|Program 2|"preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs~preset program: Change to different present program using epidural and peripheral lead to cover pain"
11222275|NCT02346383|OG002|Outcome|Program 3|"preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs~preset program: Change to different present program using epidural and peripheral lead to cover pain"
11222276|NCT02346383|EG000|Reported Event|Program 1|"preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs~preset program: Change to different present program using epidural and peripheral lead to cover pain"
11222277|NCT02346383|EG001|Reported Event|Program 2|"preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs~preset program: Change to different present program using epidural and peripheral lead to cover pain"
11222278|NCT02346383|EG002|Reported Event|Program 3|"preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs~preset program: Change to different present program using epidural and peripheral lead to cover pain"
11222279|NCT02346461|BG000|Baseline|ManNAc: Cohort A|Cohort A received oral ManNAc 3 g twice daily (6 g/day) for 7 days and, then were escalated to 6 g twice daily (12 g/day) for the remainder of the study.
11222280|NCT02346461|BG001|Baseline|ManNAc: Cohort B|Cohort B received oral ManNAc 6 g twice daily (12 g/day) for the duration of the study.
11222281|NCT02346461|BG002|Baseline|Total|Total of all reporting groups
11222282|NCT02346461|FG000|Participant Flow|ManNAc: Cohort A|Cohort A received oral ManNAc 3 g twice daily (6 g/day) for 7 days and, then were escalated to 6 g twice daily (12 g/day) for the remainder of the study.
11222283|NCT02346461|FG001|Participant Flow|ManNAc: Cohort B|Cohort B received oral ManNAc 6 g twice daily (12 g/day) for the duration of the study.
11222284|NCT02346461|OG000|Outcome|ManNAc: Cohort A|ManNAc 3 g twice daily (6 g/day) for 7 days
11222285|NCT02346461|OG001|Outcome|ManNAc: Cohort B|ManNAc 6 g twice daily (12 g/day)
11222286|NCT02346461|EG000|Reported Event|ManNAc 3 g - 7 Days|Subjects who received oral ManNAc 3 g twice daily (6 g/day) for the first 7 days.
11222287|NCT02346461|EG001|Reported Event|ManNAc 6 g - 7 Days|Subjects who received oral ManNAc 6 g twice daily (12 g/day) for the first 7 days.
10976313|NCT00939809|EG000|Reported Event|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10976314|NCT00939822|BG000|Baseline|Simvastatin|"40 mg. Simvastatin/day~Simvastatin: 40 mg Simvastatin/day"
11222288|NCT02346461|EG002|Reported Event|ManNAc 6 g - Day 8 to 30 Months|All subjects received oral ManNAc 6 g twice daily (12 g/day) from day 8 to the end of the study at 30 months.
11222289|NCT02346643|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11222290|NCT02346643|FG000|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11222291|NCT02346643|OG000|Outcome|Subjected Treated With the Permanent|All subjects treated with the Axium implantable neurostimulator
11222292|NCT02346643|EG000|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11222293|NCT02346708|BG000|Baseline|Real TMS|"TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magstim Stimulator. Repetitive pulses will be delivered to the right and left dorsolateral pre-frontal cortex (Brodmann area 46) using a frameless stereotactic navigation system and the subject's magnetic resonance imaging (MRI) in Brainsight software. Stimuli will be delivered at 20 Hz at 90% resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. Stimulation will be delivered for 10 consecutive days, excluding the weekends. This dose and duration of repetitive TMS (rTMS) is based on physiological studies of healthy adults and treatment studies of cognition in PD and Alzheimer's disease. Side of first stimulation (left vs right hemisphere) will be counterbalanced across subjects.~Real TMS: real treatment"
10976315|NCT00939822|BG001|Baseline|Placebo|"Matching Placebo~Placebo: Matching Placebo"
11222294|NCT02346708|BG001|Baseline|Sham TMS|"Sham stimulation will be delivered using a sham coil fitted with electrodes to mimic both the auditory and somatic sensation of real TMS.~Sham TMS: placebo treatment"
10976316|NCT00939822|BG002|Baseline|Total|Total of all reporting groups
10976317|NCT00939822|FG000|Participant Flow|Simvastatin|"40 mg. Simvastatin/day~Simvastatin: 40 mg Simvastatin/day"
10976318|NCT00939822|FG001|Participant Flow|Placebo|"Matching Placebo~Placebo: Matching Placebo"
10976319|NCT00939822|OG000|Outcome|Simvastatin|"40 mg. Simvastatin/day~Simvastatin: 40 mg Simvastatin/day"
10976320|NCT00939822|OG001|Outcome|Placebo|"Matching Placebo~Placebo: Matching Placebo"
10976321|NCT00939822|EG000|Reported Event|Simvastatin|"40 mg. Simvastatin/day~Simvastatin: 40 mg Simvastatin/day"
10976322|NCT00939822|EG001|Reported Event|Placebo|"Matching Placebo~Placebo: Matching Placebo"
10976323|NCT00939874|BG000|Baseline|Raltegravir|Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
10976324|NCT00939874|FG000|Participant Flow|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
10976325|NCT00939874|OG000|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
10976326|NCT00939874|EG000|Reported Event|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
10976327|NCT00939900|BG000|Baseline|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
10976328|NCT00939900|BG001|Baseline|Control|control group
10976329|NCT00939900|BG002|Baseline|Total|Total of all reporting groups
10976330|NCT00939900|FG000|Participant Flow|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
10976331|NCT00939900|FG001|Participant Flow|Control|control group
10976332|NCT00939900|OG000|Outcome|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
10976333|NCT00939900|OG001|Outcome|Control|control group
10976334|NCT00939900|EG000|Reported Event|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
10976335|NCT00939900|EG001|Reported Event|Control|control group
10976336|NCT00939952|BG000|Baseline|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
10976337|NCT00939952|FG000|Participant Flow|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
10976338|NCT00939952|OG000|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
10976339|NCT00939952|EG000|Reported Event|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
10976340|NCT00939991|BG000|Baseline|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
10976341|NCT00939991|BG001|Baseline|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
10976342|NCT00939991|BG002|Baseline|Total|Total of all reporting groups
10976343|NCT00939991|FG000|Participant Flow|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
10976344|NCT00939991|FG001|Participant Flow|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
11126276|NCT01648205|EG001|Reported Event|Placebo|"During 1 month on placebo following adverse events were reported:~Pregnancy (n=1) Gastritis (n=1) Generalized weakness (n=1)"
11222295|NCT02346708|BG002|Baseline|Total|Total of all reporting groups
10976345|NCT00939991|OG000|Outcome|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
10976346|NCT00939991|OG000|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
11222296|NCT02346708|FG000|Participant Flow|Real TMS|"TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magstim Stimulator. Repetitive pulses will be delivered to the right and left dorsolateral pre-frontal cortex (Brodmann area 46) using a frameless stereotactic navigation system and the subject's magnetic resonance imaging (MRI) in Brainsight software. Stimuli will be delivered at 20 Hz at 90% resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. This dose and duration of repetitive TMS (rTMS) is based on physiological studies of healthy adults and treatment studies of cognition in PD and Alzheimer's disease. Side of first stimulation (left vs right hemisphere) will be counterbalanced across subjects.~Real TMS: real treatment"
11222297|NCT02346708|FG001|Participant Flow|Sham TMS|"Sham stimulation will be delivered using a sham coil fitted with electrodes to mimic both the auditory and somatic sensation of real TMS.~Sham TMS: placebo treatment"
10848802|NCT00291642|BG004|Baseline|Cetirizine (CTZ) 10 mg|A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
10848803|NCT00291642|BG005|Baseline|Total Title|
10848804|NCT00291642|FG000|Participant Flow|Placebo (PBO)|A single dose of placebo was administered orally on Day 1.
10848805|NCT00291642|FG001|Participant Flow|Levocetirizine (LCTZ) 2.5 mg|A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
10848806|NCT00291642|FG002|Participant Flow|Levocetirizine (LCTZ) 5 mg|A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
10848807|NCT00291642|FG003|Participant Flow|Cetirizine (CTZ) 5 mg|A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
10848808|NCT00291642|FG004|Participant Flow|Cetirizine (CTZ) 10 mg|A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
10848809|NCT00291642|OG000|Outcome|Placebo (PBO)|A single dose of placebo was administered orally on Day 1.
10848810|NCT00291642|OG001|Outcome|Levocetirizine (LCTZ) 2.5 mg|A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
11126277|NCT01312922|BG000|Baseline|PNB01|"oral, once daily administration~PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration"
10848811|NCT00291642|OG002|Outcome|Levocetirizine (LCTZ) 5 mg|A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
10848812|NCT00291642|OG003|Outcome|Cetirizine (CTZ) 5 mg|A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
10848813|NCT00291642|OG004|Outcome|Cetirizine (CTZ) 10 mg|A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
10848814|NCT00291642|EG000|Reported Event|Placebo (PBO)|A single dose of placebo was administered orally on Day 1.
10848815|NCT00291642|EG001|Reported Event|Levocetirizine (LCTZ) 2.5 mg|A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
10848816|NCT00291642|EG002|Reported Event|Levocetirizine (LCTZ) 5 mg|A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
10848817|NCT00291642|EG003|Reported Event|Cetirizine (CTZ) 5 mg|A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
10848818|NCT00291642|EG004|Reported Event|Cetirizine (CTZ) 10 mg|A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
10848819|NCT00291655|BG000|Baseline|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
10848820|NCT00291655|FG000|Participant Flow|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
10848821|NCT00291655|OG000|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
10848822|NCT00291655|EG000|Reported Event|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
10848823|NCT00291668|BG000|Baseline|Placebo|Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
10848824|NCT00291668|BG001|Baseline|Certolizumab Pegol 200 mg|Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
10848825|NCT00291668|BG002|Baseline|Certolizumab Pegol 400 mg|Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
10848826|NCT00291668|BG003|Baseline|Total Title|
10848827|NCT00291668|FG000|Participant Flow|Placebo|Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
10848828|NCT00291668|FG001|Participant Flow|Certolizumab Pegol 200 mg|Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
10848829|NCT00291668|FG002|Participant Flow|Certolizumab Pegol 400 mg|Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
10848830|NCT00291668|OG000|Outcome|Full Analysis Set (Placebo Treated Subjects)|"The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:~Subjects with Good Clinical Practice (GCP) violations~Subjects who were not diagnosed (definitely) with Crohn's Disease~Subjects who received no dose of study medication~Subjects with no data after randomization"
10848831|NCT00291668|OG001|Outcome|Full Analysis Set (CZP 200 mg Treated Subjects)|"The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:~Subjects with Good Clinical Practice (GCP) violations~Subjects who were not diagnosed (definitely) with Crohn's Disease~Subjects who received no dose of study medication~Subjects with no data after randomization"
10848832|NCT00291668|OG002|Outcome|Full Analysis Set (CZP 400 mg Treated Subjects)|"The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:~Subjects with Good Clinical Practice (GCP) violations~Subjects who were not diagnosed (definitely) with Crohn's Disease~Subjects who received no dose of study medication~Subjects with no data after randomization"
10848833|NCT00291668|EG000|Reported Event|Placebo|Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
11222298|NCT02346708|OG000|Outcome|Real TMS|"TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magstim Stimulator. Repetitive pulses will be delivered to the right and left dorsolateral pre-frontal cortex (Brodmann area 46) using a frameless stereotactic navigation system and the subject's magnetic resonance imaging (MRI) in Brainsight software. Stimuli will be delivered at 20 Hz at 90% resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. This dose and duration of repetitive TMS (rTMS) is based on physiological studies of healthy adults and treatment studies of cognition in PD and Alzheimer's disease.52, 123 Side of first stimulation (left vs right hemisphere) will be counterbalanced across subjects.~Real TMS: real treatment"
11222299|NCT02346708|OG001|Outcome|Sham TMS|"Sham stimulation will be delivered using a sham coil fitted with electrodes to mimic both the auditory and somatic sensation of real TMS.~Sham TMS: placebo treatment"
11222300|NCT02346708|OG000|Outcome|Real TMS|"TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magstim Stimulator. Repetitive pulses will be delivered to the right and left dorsolateral pre-frontal cortex (Brodmann area 46) using a frameless stereotactic navigation system and the subject's magnetic resonance imaging (MRI) in Brainsight software. Stimuli will be delivered at 20 Hz at 90% resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. This dose and duration of repetitive TMS (rTMS) is based on physiological studies of healthy adults and treatment studies of cognition in PD and Alzheimer's disease. Side of first stimulation (left vs right hemisphere) will be counterbalanced across subjects.~Real TMS: real treatment"
11222301|NCT02346708|EG000|Reported Event|Real TMS|"TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magstim Stimulator. Repetitive pulses will be delivered to the right and dorsolateral left pre-frontal cortex (Brodmann area 46) using a frameless stereotactic navigation system and the subject's magnetic resonance imaging (MRI) in Brainsight software. Stimuli will be delivered at 20 Hz at 90% resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. This dose and duration of repetitive TMS (rTMS) is based on physiological studies of healthy adults and treatment studies of cognition in PD and Alzheimer's disease. Side of first stimulation (left vs right hemisphere) will be counterbalanced across subjects.~Real TMS: real treatment"
11222302|NCT02346708|EG001|Reported Event|Sham TMS|"Sham stimulation will be delivered using a sham coil fitted with electrodes to mimic both the auditory and somatic sensation of real TMS.~Sham TMS: placebo treatment"
11222303|NCT02346721|BG000|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
11222304|NCT02346721|FG000|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily
11222305|NCT02346721|OG000|Outcome|SOF/VEL 12 Weeks|SOF/VEL 400/100 mg FDC tablet orally once daily
11222306|NCT02346721|OG000|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
11222307|NCT02346721|OG000|Outcome|SOF/VEL 12 Weeks|SOF/VEL 400/100 mg fixed-dose combination (FDC) tablet orally once daily
11222308|NCT02346721|EG000|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
11222309|NCT02346903|BG000|Baseline|Cardiac Catheterization Patients|"Subjects will undergo the cutaneous capsaicin test. A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, ranging from 0 (no discomfort) to 10 (the worst discomfort imaginable). The cream will then be removed by washing the affected arm with cold water. The patients will be asked follow-up questions concerning their experiences with chest pain in the past and their tolerance of spicy foods. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion."
11222310|NCT02346903|FG000|Participant Flow|Cardiac Catheterization Patients|"Subjects will undergo the cutaneous capsaicin test. A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, ranging from 0 (no discomfort) to 10 (the worst discomfort imaginable). The cream will then be removed by washing the affected arm with cold water. The patients will be asked follow-up questions concerning their experiences with chest pain in the past and their tolerance of spicy foods. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion.~Capsaicin: one inch ribbon of Capzasin -HP applied to forearm for 30 minutes"
11222311|NCT02346903|OG000|Outcome|Cardiac Catheterization Patients|"Subjects will undergo the cutaneous capsaicin test. A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, ranging from 0 (no discomfort) to 10 (the worst discomfort imaginable). The cream will then be removed by washing the affected arm with cold water. The patients will be asked follow-up questions concerning their experiences with chest pain in the past and their tolerance of spicy foods. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion.~Capsaicin: one inch ribbon of Capzasin -HP applied to forearm for 30 minutes"
11222312|NCT02346903|EG000|Reported Event|Cardiac Catheterization Patients|"Subjects will undergo the cutaneous capsaicin test. A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, ranging from 0 (no discomfort) to 10 (the worst discomfort imaginable). The cream will then be removed by washing the affected arm with cold water. The patients will be asked follow-up questions concerning their experiences with chest pain in the past and their tolerance of spicy foods. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion.~Capsaicin: one inch ribbon of Capzasin -HP applied to forearm for 30 minutes"
11222313|NCT02346916|BG000|Baseline|Cardiac Catheterization Patients|"Subjects will undergo the cutaneous capsaicin test at the time of the study visit. A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, from 0 (no discomfort) to 10 (the worst discomfort imaginable). The cream will then be removed by washing the affected arm with cold water. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion. This method should allow an individual's subjective sensitivity to the TRPV1-mediated noxious stimulus of myocardial ischemia to be compared with his/her sensitivity to the TRPV1-mediated noxious stimulus of cutaneous capsaicin in extra-cardiac tissues.~Capsaicin: 1 inch ribbon of Capzasin-HP 0.1% will be a"
11222314|NCT02346916|FG000|Participant Flow|Cardiac Catheterization Patients|"All subjects will undergo the cutaneous capsaicin test at the time of the study visit; this included a one inch ribbon of Capzasin-HP Cream (0.1%) applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, from 0 (no discomfort) to 10 (the worst discomfort imaginable). The cream will then be removed by washing the affected arm with cold water. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion."
11222315|NCT02346916|OG000|Outcome|Cardiac Catheterization Patients|"All subjects will undergo the cutaneous capsaicin test at the time of the study visit; this included a one inch ribbon of Capzasin-HP Cream (0.1%) applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, from 0 (no discomfort) to 10 (the worst discomfort imaginable). The cream will then be removed by washing the affected arm with cold water. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion."
11222316|NCT02346916|EG000|Reported Event|Cardiac Catheterization Patients|"Subjects will undergo the cutaneous capsaicin test at the time of the study visit. A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, from 0 (no discomfort) to 10 (the worst discomfort imaginable). The cream will then be removed by washing the affected arm with cold water. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion. This method should allow an individual's subjective sensitivity to the TRPV1-mediated noxious stimulus of myocardial ischemia to be compared with his/her sensitivity to the TRPV1-mediated noxious stimulus of cutaneous capsaicin in extra-cardiac tissues.~Capsaicin: 1 inch ribbon of Capzasin-HP 0.1% will be applied to the forearm for 30 minutes"
11222317|NCT02347072|BG000|Baseline|All Subjects|
11222318|NCT02347072|FG000|Participant Flow|Overall Study|All Subjects Randomized
11222319|NCT02347072|OG000|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
11222320|NCT02347072|OG001|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
11222321|NCT02347072|OG002|Outcome|Placebo|Placebo MDI
11222322|NCT02347072|EG000|Reported Event|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
11222323|NCT02347072|EG001|Reported Event|Spiriva Respimat|Spiriva Respimat 5μg
11222324|NCT02347072|EG002|Reported Event|Placebo|Placebo MDI
11222325|NCT02347085|BG000|Baseline|All Subjects|
11222326|NCT02347085|FG000|Participant Flow|Overall Study|All subjects randomized
11222327|NCT02347085|OG000|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
11222328|NCT02347085|OG001|Outcome|Placebo|Placebo MDI
10879570|NCT00458484|FG006|Participant Flow|Series 2/Dose Level 3: Stereotactic Radiosurgery|"Dose Level 3: Radiation will be delivered in 3 fractions:~20 Gy x 3 fractions: Total of 60 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
11222329|NCT02347085|EG000|Reported Event|GFF MDI PT003|GFF MDI 14.4/9.6 µg
11222330|NCT02347085|EG001|Reported Event|Placebo|Placebo MDI
11222331|NCT02347098|BG000|Baseline|Intensive LDL-lowering Therapy (ILLT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
11222332|NCT02347098|BG001|Baseline|Standard Statin Monotherapy (SMT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
11222333|NCT02347098|BG002|Baseline|Total|Total of all reporting groups
11222334|NCT02347098|FG000|Participant Flow|Intensive LDL-lowering Therapy (ILLT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
11222335|NCT02347098|FG001|Participant Flow|Standard Statin Monotherapy (SMT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
11222336|NCT02347098|OG000|Outcome|Intensive LDL-lowering Therapy (ILLT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
11222337|NCT02347098|OG001|Outcome|Standard Statin Monotherapy (SMT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
11222338|NCT02347098|EG000|Reported Event|Intensive LDL-lowering Therapy (ILLT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
11222339|NCT02347098|EG001|Reported Event|Standard Statin Monotherapy (SMT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
11222340|NCT02347124|BG000|Baseline|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
11222341|NCT02347124|BG001|Baseline|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
11222342|NCT02347124|BG002|Baseline|Total|Total of all reporting groups
11222343|NCT02347124|FG000|Participant Flow|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
11222344|NCT02347124|FG001|Participant Flow|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
11222345|NCT02347124|OG000|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
11222346|NCT02347124|OG001|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
11222347|NCT02347124|EG000|Reported Event|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
11222348|NCT02347124|EG001|Reported Event|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
11222349|NCT02347176|BG000|Baseline|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11007020|NCT01089062|FG004|Participant Flow|Treatment C, Then A, Then B|"The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
11222350|NCT02347176|BG001|Baseline|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222351|NCT02347176|BG002|Baseline|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222352|NCT02347176|BG003|Baseline|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222353|NCT02347176|BG004|Baseline|Total|Total of all reporting groups
11222354|NCT02347176|FG000|Participant Flow|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
10855031|NCT00326495|BG000|Baseline|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
11126278|NCT01312922|BG001|Baseline|Citalopram|"oral, once daily administration~Citalopram: oral once daily administration"
10855032|NCT00326495|FG000|Participant Flow|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
10855033|NCT00326495|OG000|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
10855034|NCT00326495|EG000|Reported Event|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
10855035|NCT00326599|BG000|Baseline|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855036|NCT00326599|BG001|Baseline|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855037|NCT00326599|BG002|Baseline|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855038|NCT00326599|BG003|Baseline|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855039|NCT00326599|BG004|Baseline|Total|Total of all reporting groups
10855040|NCT00326599|FG000|Participant Flow|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855041|NCT00326599|FG001|Participant Flow|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855042|NCT00326599|FG002|Participant Flow|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855043|NCT00326599|FG003|Participant Flow|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855044|NCT00326599|OG000|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855045|NCT00326599|OG001|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855046|NCT00326599|OG000|Outcome|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
11126279|NCT01312922|BG002|Baseline|Pipamperone|"oral, once daily administration~Pipamperone: oral once daily administration"
11222355|NCT02347176|FG001|Participant Flow|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222356|NCT02347176|FG002|Participant Flow|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222357|NCT02347176|FG003|Participant Flow|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222358|NCT02347176|OG000|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222359|NCT02347176|OG001|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222360|NCT02347176|OG002|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222361|NCT02347176|OG003|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222362|NCT02347176|EG000|Reported Event|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222363|NCT02347176|EG001|Reported Event|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222364|NCT02347176|EG002|Reported Event|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222365|NCT02347176|EG003|Reported Event|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
11222366|NCT02347189|BG000|Baseline|Melody PB1016 Subjects Consented (i.e. Enrolled)|This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
11222367|NCT02347189|FG000|Participant Flow|Melody PB1016 Subjects Consented (i.e. Enrolled)|This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
11222368|NCT02347189|OG000|Outcome|Implanted > 24 Hours Cohort|Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 6 months.
11222369|NCT02347189|OG000|Outcome|Implanted > 24 Hours Cohort|Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 1 year.
11222370|NCT02347189|OG000|Outcome|Implanted > 24 Hours Cohort|Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 2 years.
11126280|NCT01312922|BG003|Baseline|Total|Total of all reporting groups
11222371|NCT02347189|OG000|Outcome|Catheterized Cohort: Procedure-related SAEs at 1 yr|Subjects included in this analysis were those who went to the catheterization lab for implantation of a Melody PB1016.
11222372|NCT02347189|OG001|Outcome|Catheterized Cohort: Procedure-related SAEs at 2 Yrs|Subjects included in this analysis were those who went to the catheterization lab for implantation of a Melody PB1016.
11222373|NCT02347189|OG002|Outcome|Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr|Subjects included in this analysis were those who were implanted with the Melody PB1016 > 24 hours.
11222374|NCT02347189|OG003|Outcome|Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs|Subjects included in this analysis were those who were implanted with the Melody PB1016 > 24 hours.
11222375|NCT02347189|OG000|Outcome|Implanted > 24 Hours Cohort|Subjects included in this analysis were those who were successfully implanted
11222376|NCT02347189|OG000|Outcome|Implanted > 24 Hours Cohort / Freedom From Stent Fracture|Subjects included in this analysis were those successfully implanted with a Melody TPV PB1016 for > 24 hours.
11222377|NCT02347189|OG001|Outcome|Implanted > 24 Hours Cohort / Freedom From TPV Re-intervention|Subjects included in this analysis were those successfully implanted with a Melody TPV PB1016 for > 24 hours.
11222378|NCT02347189|OG002|Outcome|Implanted > 24 Hours Cohort / Freedom From All-Cause Mortality|Subjects included in this analysis were those successfully implanted with a Melody TPV PB1016 for > 24 hours.
11222379|NCT02347189|OG003|Outcome|Implanted > 24 Hours Cohort / Freedom From RVOT Reoperation|Subjects included in this analysis were those successfully implanted with a Melody TPV PB1016 for > 24 hours.
11222380|NCT02347189|EG000|Reported Event|Melody PB1016 Subjects Consented (i.e. Enrolled)|This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
11222381|NCT02347332|BG000|Baseline|Vinflunine Plus Methotrexate|"Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks~Vinflunine"
11222382|NCT02347332|BG001|Baseline|Methotrexate|"Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks~Methotrexate"
11222383|NCT02347332|BG002|Baseline|Total|Total of all reporting groups
11222384|NCT02347332|FG000|Participant Flow|Vinflunine Plus Methotrexate|"Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks~Vinflunine"
11222385|NCT02347332|FG001|Participant Flow|Methotrexate|"Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks~Methotrexate"
11222386|NCT02347332|OG000|Outcome|Vinflunine Plus Methotrexate|"Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks~Vinflunine"
11222387|NCT02347332|OG001|Outcome|Methotrexate|"Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks~Methotrexate"
11222388|NCT02347332|EG000|Reported Event|Vinflunine Plus Methotrexate|"Vinflunine IV 280mg/m2 Day1 plus Methotrexate IV 30mg/m2 on Day 1 and Dy 8 every 3 cycles~Vinflunine"
11222389|NCT02347332|EG001|Reported Event|Methotrexate|"Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks~Methotrexate"
11222390|NCT02347345|BG000|Baseline|Active Injection Drug Use (IDU)|In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
11222391|NCT02347345|BG001|Baseline|Former Injection Drug Use (Former IDU)|In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
11222392|NCT02347345|BG002|Baseline|Healthy Volunteers|HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
11222393|NCT02347345|BG003|Baseline|Total|Total of all reporting groups
11222394|NCT02347345|FG000|Participant Flow|Active Injection Drug Use (IDU)|In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
11222395|NCT02347345|FG001|Participant Flow|Former Injection Drug Use (Former IDU)|In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
11222396|NCT02347345|FG002|Participant Flow|Healthy Volunteers|HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
11222397|NCT02347345|OG000|Outcome|Active Injection Drug Use (IDU)|"In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks~Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks"
11222398|NCT02347345|OG001|Outcome|Former Injection Drug Use (Former IDU)|"In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks~Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks"
11222399|NCT02347345|OG002|Outcome|Healthy Volunteers|HIV, HCV and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at the screening visit.
11222400|NCT02347345|OG000|Outcome|Active Injection Drug Use (IDU)|In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
10855047|NCT00326599|EG000|Reported Event|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
11126281|NCT01312922|FG000|Participant Flow|PNB01|"oral, once daily administration~PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration"
11222401|NCT02347345|OG001|Outcome|Former Injection Drug Use (Former IDU)|In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
11222402|NCT02347345|OG002|Outcome|Healthy Volunteers|HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
11222403|NCT02347345|EG000|Reported Event|Active Injection Drug Use (IDU)|In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
11222404|NCT02347345|EG001|Reported Event|Former Injection Drug Use (Former IDU)|In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
11222405|NCT02347345|EG002|Reported Event|Healthy Volunteers|HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
11222406|NCT02347410|BG000|Baseline|SIFS Graft Containment Device|"Investigational~SIFS graft containment device: The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied."
11222407|NCT02347410|FG000|Participant Flow|SIFS Graft Containment Device|Investigation Group: Subjects underwent a lumbar interbody fusion using the SIFS Graft Containment Device and supplemental posterior fixation.
11222408|NCT02347410|OG000|Outcome|SIFS Investigation Gp|"Investigational~All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied."
11222409|NCT02347410|OG000|Outcome|Investigation Group|"Investigational~All subjects (102) were treated with the SIFS device, filled with bone graft. Bilateral posterior fixation was applied."
11222410|NCT02347410|OG000|Outcome|Investigation Group|This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.
11222411|NCT02347410|OG000|Outcome|SIFS Graft Containment Device|Subjects underwent Interbody Fusion using the Graft Containment Device with supplemental fixation.
11222412|NCT02347410|OG000|Outcome|Investigation Group|Subjects underwent Interbody Fusion using the Graft Containment Device with supplemental fixation.
11222413|NCT02347410|OG000|Outcome|Participants Working at Baseline|This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.
11222414|NCT02347410|OG001|Outcome|Participants Working at 24-Month Visit|This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
11222415|NCT02347410|EG000|Reported Event|Investigation Group|This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.
11222416|NCT02347488|BG000|Baseline|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
11222417|NCT02347488|FG000|Participant Flow|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
11222418|NCT02347488|OG000|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
11222419|NCT02347488|OG001|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
11222420|NCT02347488|OG000|Outcome|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
11222421|NCT02347488|EG000|Reported Event|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery.~Adverse events were not reported per arm because surgery patients were assessed for adverse events after experiencing both methods."
11222422|NCT02347605|BG000|Baseline|Sequence 1|Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
11222423|NCT02347605|BG001|Baseline|Sequence 2|Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
11222424|NCT02347605|BG002|Baseline|Sequence 3|Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
11222425|NCT02347605|BG003|Baseline|Sequence 4|Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
11222426|NCT02347605|BG004|Baseline|Sequence 5|Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
11222427|NCT02347605|BG005|Baseline|Sequence 6|Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
11222428|NCT02347605|BG006|Baseline|Total|Total of all reporting groups
11222429|NCT02347605|FG000|Participant Flow|Sequence 1|Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
11222430|NCT02347605|FG001|Participant Flow|Sequence 2|Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
11222431|NCT02347605|FG002|Participant Flow|Sequence 3|Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
11222432|NCT02347605|FG003|Participant Flow|Sequence 4|Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
11222433|NCT02347605|FG004|Participant Flow|Sequence 5|Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
11222434|NCT02347605|FG005|Participant Flow|Sequence 6|Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
11222435|NCT02347605|OG000|Outcome|Nicotine Lozenge Prior to Cue Exposure|"Nicotine lozenge is used 15 minutes prior to smoking cue exposure~Nicotine lozenge 4 mg"
11222436|NCT02347605|OG001|Outcome|Placebo Lozenge Prior to Cue Exposure|"Placebo lozenge is used 15 minutes prior to smoking cue exposure~Placebo lozenge"
11222437|NCT02347605|OG002|Outcome|Control Condition: Lozenge After Cue Exposure|"Lozenge is used immediately after smoking cue exposure~Nicotine lozenge 4 mg"
11222438|NCT02347605|EG000|Reported Event|Nicotine Lozenge Prior to Cue Exposure|"Nicotine lozenge is used 15 minutes prior to smoking cue exposure~Nicotine lozenge 4 mg"
11126282|NCT01312922|FG001|Participant Flow|Citalopram|"oral, once daily administration~Citalopram: oral once daily administration"
11222439|NCT02347605|EG001|Reported Event|Placebo Lozenge Prior to Cue Exposure|"Placebo lozenge is used 15 minutes prior to smoking cue exposure~Placebo lozenge"
11126283|NCT01312922|FG002|Participant Flow|Pipamperone|"oral, once daily administration~Pipamperone: oral once daily administration"
11222440|NCT02347605|EG002|Reported Event|Control Condition: Lozenge After Cue Exposure|"Lozenge is used immediately after smoking cue exposure~Nicotine lozenge 4 mg"
11222441|NCT02347631|BG000|Baseline|Alcon DAILIES TOTAL1, and ACUVUE TRUEYE Contact Lenses|"Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.~Intervention 1: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months~Washout period - 1 month~Intervention 2: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm & 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11336516|NCT03567382|FG000|Participant Flow|High-risk Mothers|"Mothers with high-risk HBV (defined as viral load >10^6 and/or HBeAg positivity) will be treated with tenofovir disoproxil fumarate (TDF) to further reduce the risk of vertical transmission of HBV. All HBV-exposed infants (regardless of mother's status of high- or low-risk HBV) will receive monovalent HBV vaccine within 24 hours of life.~Tenofovir Disoproxil Fumarate: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.~Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life."
11222442|NCT02347631|BG001|Baseline|ACUVUE TRUEYE, and Alcon DAILIES TOTAL1 Contact Lenses|"Comparison of Acuvue TruEye versus Alcon Dailies Total 1 contact lenses when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.~Intervention 1: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm & 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months~Washout period - 1 month~Intervention 2 : Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222443|NCT02347631|BG002|Baseline|Total|Total of all reporting groups
11224524|NCT02360488|FG001|Participant Flow|In-Clinic Therapy|"The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education.~In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions."
10855048|NCT00326599|EG001|Reported Event|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855049|NCT00326599|EG002|Reported Event|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855050|NCT00326599|EG003|Reported Event|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
10855051|NCT00326612|BG000|Baseline|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
10855052|NCT00326612|BG001|Baseline|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
10855053|NCT00326612|BG002|Baseline|Total|Total of all reporting groups
10855054|NCT00326612|FG000|Participant Flow|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
10855055|NCT00326612|FG001|Participant Flow|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
10855056|NCT00326612|OG000|Outcome|Intranasal Midazolam|Median time to seizure cessation from medication administration to seizures stop time.
10855057|NCT00326612|OG001|Outcome|Rectal Diazepam|Median time to seizure cessation from medication administration to seizures stop time.
10855058|NCT00326612|OG000|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
10855059|NCT00326612|OG001|Outcome|Rectal Diazepam|Includes intubation
10855060|NCT00326612|OG000|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
10855061|NCT00326612|OG001|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
10855062|NCT00326612|EG000|Reported Event|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
10855063|NCT00326612|EG001|Reported Event|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
10855064|NCT00326625|BG000|Baseline|Glatiramer Acetate 40mg|Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day
10855065|NCT00326625|BG001|Baseline|Placebo|Pre-filled syringe of matching placebo, administered subcutaneously once a day
10855066|NCT00326625|BG002|Baseline|Total|Total of all reporting groups
10855067|NCT00326625|FG000|Participant Flow|Glatiramer Acetate 40mg|Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day
10855068|NCT00326625|FG001|Participant Flow|Placebo|Pre-filled syringe of matching placebo, administered subcutaneously once a day
10855069|NCT00326625|OG000|Outcome|Glatiramer Acetate 40mg|Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day
10855070|NCT00326625|OG001|Outcome|Placebo|Pre-filled syringe of matching placebo, administered subcutaneously once a day
10855071|NCT00326625|EG000|Reported Event|Glatiramer Acetate 40mg|Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day
10855072|NCT00326625|EG001|Reported Event|Placebo|Pre-filled syringe of matching placebo, administered subcutaneously once a day
10855073|NCT00326716|BG000|Baseline|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855074|NCT00326716|BG001|Baseline|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855075|NCT00326716|BG002|Baseline|Total|Total of all reporting groups
11126284|NCT01312922|OG000|Outcome|PNB01|"oral, once daily administration~PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration"
11222444|NCT02347631|FG000|Participant Flow|Alcon DAILIES TOTAL1, Then ACUVUE TRUEYE Contact Lenses|"Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.~Intervention 1: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months~Washout period - 1 month~Intervention 2: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm & 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222445|NCT02347631|FG001|Participant Flow|ACUVUE TRUEYE, Then Alcon DAILIES TOTAL1 Contact Lenses|"Comparison of Acuvue TruEye versus Alcon Dailies Total 1 contact lenses when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.~Intervention 1: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm & 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months~Washout period - 1 month~Intervention 2 : Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222446|NCT02347631|OG000|Outcome|Alcon DAILIES TOTAL1 Contact Lenses|"A 1 month washout will precede the intervention.~Intervention: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222447|NCT02347631|OG001|Outcome|ACUVUE TRUEYE Contact Lenses|"A 1 month washout will precede the intervention.~Intervention: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm & 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222448|NCT02347631|OG000|Outcome|ACUVUE TRUEYE Contact Lenses|"A 1 month washout will precede the intervention.~Intervention 2: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm & 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222449|NCT02347631|OG001|Outcome|Alcon DAILIES Contact Lenses|"A 1 month washout will precede the intervention.~Intervention 1: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222450|NCT02347631|EG000|Reported Event|Alcon DAILIES TOTAL1 Contact Lenses|"A 1 month washout will precede the intervention.~Intervention: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222451|NCT02347631|EG001|Reported Event|ACUVUE TRUEYE Contact Lenses|"A 1 month washout will precede the intervention.~Intervention: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm & 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months"
11222452|NCT02347657|BG000|Baseline|Placebo|Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA tablet administered orally in the evening up to Week 24.
11222453|NCT02347657|BG001|Baseline|VX-661/IVA|VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg tablet administered orally in the evening up to Week 24.
11222454|NCT02347657|BG002|Baseline|Total|Total of all reporting groups
11222455|NCT02347657|FG000|Participant Flow|Placebo|Placebo matched to VX-661 plus Ivacaftor (IVA, VX-770) fixed dose combination (FDC) tablet administered orally in the morning and placebo matched to IVA tablet administered orally in the evening up to Week 24.
11222456|NCT02347657|FG001|Participant Flow|VX-661/IVA|VX-661 100 milligram (mg) plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg tablet administered orally in the evening up to Week 24.
11222457|NCT02347657|OG000|Outcome|Placebo|Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA tablet administered orally in the evening up to Week 24.
11222458|NCT02347657|OG001|Outcome|VX-661/IVA|VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg tablet administered orally in the evening up to Week 24.
11222459|NCT02347657|OG000|Outcome|VX-661/IVA|VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg tablet administered orally in the evening up to Week 24.
11222460|NCT02347657|EG000|Reported Event|Placebo|Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA tablet administered orally in the evening up to Week 24.
11222461|NCT02347657|EG001|Reported Event|VX-661/IVA|VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg tablet administered orally in the evening up to Week 24.
11222462|NCT02347761|BG000|Baseline|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
11126285|NCT01312922|OG001|Outcome|Citalopram|"oral, once daily administration~Citalopram: oral once daily administration"
11126286|NCT01312922|OG002|Outcome|Pipamperone|"oral, once daily administration~Pipamperone: oral once daily administration"
11222463|NCT02347761|BG001|Baseline|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
11222464|NCT02347761|BG002|Baseline|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
11343685|NCT03926039|OG000|Outcome|Sharing Decision-making Program Interventions|"Description of conventional traditional treatment options and add sharing decision-making program The intervention measures in this study sharing decision-making plan mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process.~sharing decision-making program: Sharing decision-making talks and decision-making assistance tools used in the process"
11343686|NCT03926039|OG001|Outcome|Description of Traditional Treatment Options|Description of conventional traditional treatment options
10855076|NCT00326716|FG000|Participant Flow|Mother ATV 300 mg / RTV 100 mg|Mothers receiving atazanavir (ATV) / ritonavir (RTV) 300/100 mg once daily (QD) + lamivudine (ZDV) / zidovudine (3TC) 300/150 mg twice daily (BID) during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
11126287|NCT01312922|EG000|Reported Event|PNB01|"oral, once daily administration~PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration"
11222465|NCT02347761|BG003|Baseline|Total|Total of all reporting groups
11222466|NCT02347761|FG000|Participant Flow|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
11222467|NCT02347761|FG001|Participant Flow|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
11343687|NCT03926039|EG000|Reported Event|Sharing Decision-making Program Interventions|"Description of conventional traditional treatment options and add sharing decision-making program The intervention measures in this study sharing decision-making plan mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process.~sharing decision-making program: Sharing decision-making talks and decision-making assistance tools used in the process"
11343688|NCT03926039|EG001|Reported Event|Description of Traditional Treatment Options|Description of conventional traditional treatment options
10855077|NCT00326716|FG001|Participant Flow|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855078|NCT00326716|FG002|Participant Flow|Infants ATV 300 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 300 mg / RTV 100 mg during the third trimester of pregnancy.
10855079|NCT00326716|FG003|Participant Flow|Infants ATV 400 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 400 mg / RTV 100 mg during the third trimester of pregnancy.
10855080|NCT00326716|OG000|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855081|NCT00326716|OG001|Outcome|Mothers ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855082|NCT00326716|OG000|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855083|NCT00326716|OG001|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855084|NCT00326716|OG000|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855085|NCT00326716|OG001|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855086|NCT00326716|OG000|Outcome|Infant ATV 300 mg / RTV 100 mg|
10855087|NCT00326716|OG001|Outcome|Infant ATV 400 mg / RTV 100 mg|
10855088|NCT00326716|OG000|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
10855089|NCT00326716|OG001|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
10855090|NCT00326716|OG000|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
10855091|NCT00326716|OG001|Outcome|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
10855092|NCT00326716|OG000|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10976347|NCT00939991|EG000|Reported Event|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
10976348|NCT00939991|EG001|Reported Event|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
10976349|NCT00940017|BG000|Baseline|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
10976350|NCT00940017|FG000|Participant Flow|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
10976351|NCT00940017|OG000|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
10976352|NCT00940017|EG000|Reported Event|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
10976353|NCT00940108|BG000|Baseline|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976354|NCT00940108|BG001|Baseline|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
11222468|NCT02347761|FG002|Participant Flow|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
11222469|NCT02347761|OG000|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
11222470|NCT02347761|OG001|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
11222471|NCT02347761|OG002|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
11222472|NCT02347761|EG000|Reported Event|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
10976355|NCT00940108|BG002|Baseline|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
11222473|NCT02347761|EG001|Reported Event|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
11222474|NCT02347761|EG002|Reported Event|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
11222475|NCT02347774|BG000|Baseline|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
11222476|NCT02347774|BG001|Baseline|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
11222477|NCT02347774|BG002|Baseline|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
11222478|NCT02347774|BG003|Baseline|Total|Total of all reporting groups
11222479|NCT02347774|FG000|Participant Flow|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
11222480|NCT02347774|FG001|Participant Flow|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
11222481|NCT02347774|FG002|Participant Flow|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
10855093|NCT00326716|OG001|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
11222482|NCT02347774|OG000|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
11222483|NCT02347774|OG001|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
10855094|NCT00326716|OG000|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855095|NCT00326716|OG001|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
11222484|NCT02347774|OG002|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
11222485|NCT02347774|EG000|Reported Event|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
11222486|NCT02347774|EG001|Reported Event|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
11222487|NCT02347774|EG002|Reported Event|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
11222488|NCT02347787|BG000|Baseline|Usual Clinician Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site.~Usual care"
10855096|NCT00326716|OG002|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855097|NCT00326716|OG000|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855098|NCT00326716|OG001|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855099|NCT00326716|OG002|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855100|NCT00326716|OG000|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855101|NCT00326716|OG001|Outcome|Mothers ATV 400 mg / RTV 100 mg|Infants born to mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855102|NCT00326716|OG000|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855103|NCT00326716|OG001|Outcome|Infant ATV 400 mg / RTV 100 mg|Infansts of mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855104|NCT00326716|EG000|Reported Event|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
10855105|NCT00326716|EG001|Reported Event|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
10855106|NCT00326716|EG002|Reported Event|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855107|NCT00326716|EG003|Reported Event|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
10855108|NCT00326781|BG000|Baseline|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
11222489|NCT02347787|BG001|Baseline|CHW Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.~IMPaCT: The IMPaCT intervention has three stages:~Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.~Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.~Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group."
11222490|NCT02347787|BG002|Baseline|Total|Total of all reporting groups
11222491|NCT02347787|FG000|Participant Flow|Usual Clinician Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site.~Usual care"
11222492|NCT02347787|FG001|Participant Flow|CHW Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.~IMPaCT: The IMPaCT intervention has three stages:~Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.~Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.~Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group."
11222493|NCT02347787|OG000|Outcome|Usual Clinician Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site.~Usual care"
11222494|NCT02347787|OG001|Outcome|CHW Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.~IMPaCT: The IMPaCT intervention has three stages:~Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.~Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.~Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group."
11222495|NCT02347787|OG000|Outcome|Usual Clinician Support - 6 Months|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site.~Usual care"
11222496|NCT02347787|OG001|Outcome|CHW Support - 6 Months|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.~IMPaCT: The IMPaCT intervention has three stages:~Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.~Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.~Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group."
11222497|NCT02347787|OG002|Outcome|Usual Clinician Support - 9 Months|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site.~Usual care"
11222498|NCT02347787|OG003|Outcome|CHW Support - 9 Months|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.~IMPaCT: The IMPaCT intervention has three stages:~Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.~Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.~Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group."
11222499|NCT02347787|OG000|Outcome|CHW Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.~IMPaCT: The IMPaCT intervention has three stages:~Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.~Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.~Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group."
11343689|NCT03927911|BG000|Baseline|Cohort 1:Open or Mini-open Surgical Technique|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11343690|NCT03927911|BG001|Baseline|Cohort 1 Control Group|Standard of Care
10976356|NCT00940108|BG003|Baseline|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976357|NCT00940108|BG004|Baseline|Total|Total of all reporting groups
11126288|NCT01312922|EG001|Reported Event|Citalopram|"oral, once daily administration~Citalopram: oral once daily administration"
11222500|NCT02347787|EG000|Reported Event|Usual Clinician Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site.~Usual care"
11222501|NCT02347787|EG001|Reported Event|CHW Support|"Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.~IMPaCT: The IMPaCT intervention has three stages:~Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.~Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.~Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group."
11222502|NCT02347813|BG000|Baseline|No Intervention, Then Pioglitazone|"After enrollment, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. Then they will begin the pioglitazone regimen for 24 more weeks, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. There was no washout period.~Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months."
11222503|NCT02347813|BG001|Baseline|Pioglitazone, Then no Intervention|"Subjects will begin the 24 week pioglitazone regimen immediately after enrollment, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. After 24 weeks of drug, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. There was no washout period.~Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months."
11222504|NCT02347813|BG002|Baseline|Total|Total of all reporting groups
11222505|NCT02347813|FG000|Participant Flow|No Intervention, Then Pioglitazone|"After enrollment, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. Then they will begin the pioglitazone regimen for 24 more weeks, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. There was no washout period.~Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months."
11222506|NCT02347813|FG001|Participant Flow|Pioglitazone, Then no Intervention|"Subjects will begin the 24 week pioglitazone regimen immediately after enrollment, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. After 24 weeks of drug, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. There was no washout period.~Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months."
11222507|NCT02347813|OG000|Outcome|No Intervention|Standard of care
11222508|NCT02347813|OG001|Outcome|Pioglitazone|Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
11222509|NCT02347813|EG000|Reported Event|No Intervention|Standard of Care
11222510|NCT02347813|EG001|Reported Event|Pioglitazone|Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
11222511|NCT02348008|BG000|Baseline|Arm A - Phase 1b Dose Escalation Cohort|"Cohort 1 will consist of 3-6 patients who will receive MK-3475 200mg and bevacizumab 10mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions.~Cohort 2 will consist of 3-9 patients who will receive MK-3475 200mg and bevacizumab 15mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions.~If none of the 3 subjects experience a dose limiting toxicity (DLT) during the first cycle of therapy, an additional 3 subjects will be enrolled at dose level 2. If all three subjects in dose level 2 complete the first cycle of therapy without DLT, 3 more subjects will be enrolled to ensure only 0-1 of 6 subjects have a DLT. There will be no further escalation beyond dose level 2.~MK-3475: Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV~Bevacizumab: Arm A: Phase 1b Cohort 1: 10mg IV; Arm A: Phase 1b Cohort 2: 15mg IV"
11222512|NCT02348008|BG001|Baseline|Arm B - Phase II Investigational Treatment|"The maximum safe dose of MK-3475 in combination bevacizumab (as determined in the phase 1b cohort) will be given on day 1 of each 21 day cycle.~MK-3475: Arm B: Phase II Treatment: 200mg IV~Bevacizumab: Arm B: Phase II Treatment: administered at the maximum safe dose of 5mg or 10mg as established in the Phase 1b dose escalation cohort study."
11222513|NCT02348008|BG002|Baseline|Total|Total of all reporting groups
11222514|NCT02348008|FG000|Participant Flow|Arm A - Phase 1b Dose Escalation Cohort|"Cohort 1 will consist of 3-6 patients who will receive MK-3475 200mg and bevacizumab 10mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions.~If none of the 3 subjects experience a dose limiting toxicity (DLT) during the first cycle of therapy, an additional 3 subjects will be enrolled at dose level 2. If all three subjects in dose level 2 complete the first cycle of therapy without DLT, 3 more subjects will be enrolled to ensure only 0-1 of 6 subjects have a DLT. There will be no further escalation beyond dose level 2.~MK-3475: Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV~Bevacizumab: Arm A: Phase 1b Cohort 1: 10mg IV;"
11222515|NCT02348008|FG001|Participant Flow|Arm A - Phase Ib Dose Ecalation Cohort 2|"Cohort 2 will consist of 3-9 patients who will receive MK-3475 200mg and bevacizumab 15mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions.~If none of the 3 subjects experience a dose limiting toxicity (DLT) during the first cycle of therapy, an additional 3 subjects will be enrolled at dose level 2. If all three subjects in dose level 2 complete the first cycle of therapy without DLT, 3 more subjects will be enrolled to ensure only 0-1 of 6 subjects have a DLT. There will be no further escalation beyond dose level 2.~MK-3475: Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV~Bevacizumab: Arm A: Phase 1b Cohort 2: 15mg IV"
11126289|NCT01312922|EG002|Reported Event|Pipamperone|"oral, once daily administration~Pipamperone: oral once daily administration"
11222516|NCT02348008|FG002|Participant Flow|Arm B - Phase II Investigational Treatment|"The maximum safe dose of MK-3475 in combination bevacizumab (as determined in the phase 1b cohort) will be given on day 1 of each 21 day cycle.~MK-3475: Arm B: Phase II Treatment: 200mg IV~Bevacizumab: Arm B: Phase II Treatment: administered at the maximum safe dose of 5mg or 10mg as established in the Phase 1b dose escalation cohort study."
11222517|NCT02348008|OG000|Outcome|Arm A - Phase 1b Dose Escalation Cohort|"Cohort 1 will consist of 3-6 patients who will receive MK-3475 200mg and bevacizumab 10mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions.~Cohort 2 will consist of 3-9 patients who will receive MK-3475 200mg and bevacizumab 15mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions.~If none of the 3 subjects experience a dose limiting toxicity (DLT) during the first cycle of therapy, an additional 3 subjects will be enrolled at dose level 2. If all three subjects in dose level 2 complete the first cycle of therapy without DLT, 3 more subjects will be enrolled to ensure only 0-1 of 6 subjects have a DLT. There will be no further escalation beyond dose level 2.~MK-3475: Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV~Bevacizumab: Arm A: Phase 1b Cohort 1: 10mg IV; Arm A: Phase 1b Cohort 2: 15mg IV"
11222518|NCT02348008|OG001|Outcome|Arm B - Phase II Investigational Treatment|"The maximum safe dose of MK-3475 in combination bevacizumab (as determined in the phase 1b cohort) will be given on day 1 of each 21 day cycle.~MK-3475: Arm B: Phase II Treatment: 200mg IV~Bevacizumab: Arm B: Phase II Treatment: administered at the maximum safe dose of 5mg or 10mg as established in the Phase 1b dose escalation cohort study."
11222519|NCT02348008|OG000|Outcome|All Subjects|Adverse events are summarized for all study participants who received at least one dose of study drug.
11222520|NCT02348008|EG000|Reported Event|All Subjects|"Adverse events are summarized for all study participants who received at least one dose of study drug. Per the protocol, the safety analysis population will comprise all subjects who received at least one dose of study drug. Consequently, no per-group analyses were planned or performed."
11222521|NCT02348385|BG000|Baseline|Healthy Tobacco Smokers|Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
11222522|NCT02348385|BG001|Baseline|Healthy Nonsmokers|Healthy Nonsmoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
11222523|NCT02348385|BG002|Baseline|Total|Total of all reporting groups
11222524|NCT02348385|FG000|Participant Flow|Healthy Tobacco Smokers|"There is only one arm to the study. All subjects will receive amphetamine~Amphetamine: Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered."
11222525|NCT02348385|FG001|Participant Flow|Healthy Nonsmokers|"There is only one arm to the study. All subjects will receive amphetamine~Amphetamine: Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered."
11222526|NCT02348385|OG000|Outcome|Male Healthy Tobacco Smokers|Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
11222527|NCT02348385|OG001|Outcome|Male Healthy Nonsmokers|Healthy Nonsmoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
11222528|NCT02348385|OG002|Outcome|Female Healthy Tobacco Smokers|Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
11222529|NCT02348385|OG003|Outcome|Female Healthy Nonsmokers|Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
11222530|NCT02348385|EG000|Reported Event|Healthy Tobacco Smokers|Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
11222531|NCT02348385|EG001|Reported Event|Healthy Nonsmokers|Healthy Nonsmoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
11222532|NCT02348489|BG000|Baseline|SGI-110 (Guadecitabine)|Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
11222533|NCT02348489|BG001|Baseline|Treatment Choice|One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
11222534|NCT02348489|BG002|Baseline|Total|Total of all reporting groups
11222535|NCT02348489|FG000|Participant Flow|SGI-110 (Guadecitabine)|Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
11222536|NCT02348489|FG001|Participant Flow|Treatment Choice|One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
11222537|NCT02348489|OG000|Outcome|SGI-110 (Guadecitabine)|Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
11222538|NCT02348489|OG001|Outcome|Treatment Choice|One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
11222539|NCT02348489|OG000|Outcome|SGI-110 (Guadecitabine)|Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.
11222540|NCT02348489|OG001|Outcome|Treatment Choice|One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
11222541|NCT02348489|EG000|Reported Event|SGI-110 (Guadecitabine)|Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.
11222542|NCT02348489|EG001|Reported Event|Treatment Choice|One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
11222543|NCT02348593|BG000|Baseline|75 mg of JZP-110|75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222544|NCT02348593|BG001|Baseline|150 mg JZP-110|Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
11222545|NCT02348593|BG002|Baseline|300 mg of JZP-110|Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
11222546|NCT02348593|BG003|Baseline|Placebo|Placebo administered orally, QD, for the 12 week treatment phase.
11222547|NCT02348593|BG004|Baseline|Total|Total of all reporting groups
11222548|NCT02348593|FG000|Participant Flow|75 mg of JZP-110|75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222549|NCT02348593|FG001|Participant Flow|150 mg JZP-110|Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
11222550|NCT02348593|FG002|Participant Flow|300 mg of JZP-110|Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
11222551|NCT02348593|FG003|Participant Flow|Placebo|Placebo administered orally, QD, for the 12 week treatment phase.
11343691|NCT03927911|BG002|Baseline|Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort)|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11222552|NCT02348593|OG000|Outcome|Placebo|Placebo administered orally, QD, for the 12 week treatment phase.
11222553|NCT02348593|OG001|Outcome|75 mg of JZP-110|75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222554|NCT02348593|OG002|Outcome|150 mg JZP-110|Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
11222555|NCT02348593|OG003|Outcome|300 mg of JZP-110|Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
11222556|NCT02348593|EG000|Reported Event|Placebo|Placebo administered orally, QD, for the 12 week treatment phase.
11222557|NCT02348593|EG001|Reported Event|75 mg of JZP-110|75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222558|NCT02348593|EG002|Reported Event|150 mg JZP-110|Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
11222559|NCT02348593|EG003|Reported Event|300 mg of JZP-110|Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
11222560|NCT02348606|BG000|Baseline|37.5 mg of JZP-110|37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222561|NCT02348606|BG001|Baseline|75 mg of JZP-110|75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222562|NCT02348606|BG002|Baseline|150 mg of JZP-110|Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.
11222563|NCT02348606|BG003|Baseline|300 mg of JZP-110|Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
11222564|NCT02348606|BG004|Baseline|Placebo|Placebo administered orally, QD, for the 12 week treatment phase.
11222565|NCT02348606|BG005|Baseline|Total|Total of all reporting groups
11222566|NCT02348606|FG000|Participant Flow|37.5 mg of JZP-110|37.5 mg JZP-110 administered orally, once daily (QD), for the 12-week treatment phase.
11222567|NCT02348606|FG001|Participant Flow|75 mg of JZP-110|75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222568|NCT02348606|FG002|Participant Flow|150 mg of JZP-110|Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.
11222569|NCT02348606|FG003|Participant Flow|300 mg of JZP-110|Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
11343692|NCT03927911|BG003|Baseline|Cohort 2 Control Group|Standard of Care
11222570|NCT02348606|FG004|Participant Flow|Placebo|Placebo administered orally, QD, for the 12 week treatment phase.
11222571|NCT02348606|OG000|Outcome|37.5 mg of JZP-110|37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222572|NCT02348606|OG001|Outcome|75 mg of JZP-110|75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222573|NCT02348606|OG002|Outcome|150 mg of JZP-110|Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.
11222574|NCT02348606|OG003|Outcome|300 mg of JZP-110|Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
11222575|NCT02348606|OG004|Outcome|Placebo|Placebo administered orally, QD, for the 12 week treatment phase.
11222576|NCT02348606|EG000|Reported Event|37.5 mg of JZP-110|37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11222577|NCT02348606|EG001|Reported Event|75 mg of JZP-110|75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
11343693|NCT03927911|BG004|Baseline|Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort)|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11222578|NCT02348606|EG002|Reported Event|150 mg of JZP-110|Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.
11222579|NCT02348606|EG003|Reported Event|300 mg of JZP-110|Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
11222580|NCT02348606|EG004|Reported Event|Placebo|Placebo administered orally, QD, for the 12 week treatment phase.
11222581|NCT02348619|BG000|Baseline|Double-Blind Withdrawal Phase|
11222582|NCT02348619|FG000|Participant Flow|JZP-110|Start at 75 mg, titrate up to 150 or 300 mg, or down at any time.
11222583|NCT02348619|FG001|Participant Flow|Placebo|Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
11222584|NCT02348619|OG000|Outcome|JZP-110|Start at 75 mg, titrate up to 150 or 300 mg, or down at any time.
11222585|NCT02348619|OG001|Outcome|Placebo|Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
11222586|NCT02348619|EG000|Reported Event|JZP-110 (Entire Study)|Across the entire study.
11222587|NCT02348619|EG001|Reported Event|Placebo (Randomized Withdrawal)|During the randomized withdrawal phase only.
11222588|NCT02348632|BG000|Baseline|Open-label Period|643 subjects comprised the safety population.
11222589|NCT02348632|FG000|Participant Flow|JZP-110|Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.
11222590|NCT02348632|FG001|Participant Flow|Placebo|Placebo administered orally, QD, for the 2-week randomized withdrawal period.
11222591|NCT02348632|OG000|Outcome|JZP-110|Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.
11222592|NCT02348632|OG001|Outcome|Placebo|JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.
11222593|NCT02348632|EG000|Reported Event|JZP-110|Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.
11222594|NCT02348632|EG001|Reported Event|Placebo|JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.
11222595|NCT02348658|BG000|Baseline|All Participants|All participants who received either 1 of the two treatment sequences: Sequence 1: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2 or Sequence 2: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
11222596|NCT02348658|FG000|Participant Flow|TAK-536TCH Fasted + TAK-536TCH Fed|TAK-536TCH (20 milligram [mg]/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2.
11222597|NCT02348658|FG001|Participant Flow|TAK-536TCH Fed + TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
11222598|NCT02348658|OG000|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
11222599|NCT02348658|OG001|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
11222600|NCT02348658|EG000|Reported Event|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
11222601|NCT02348658|EG001|Reported Event|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
11222602|NCT02348684|BG000|Baseline|Radiation Therapy Groups|"Risk groups based on dosimetric radiation parameters.~Radiation therapy groups: Radiation Therapy treatment between 2000 and 2007."
11222603|NCT02348684|FG000|Participant Flow|Radiation Therapy Groups|"Risk groups based on dosimetric radiation parameters and eligibility criteria.~Radiation therapy groups: 3D Conformal Radiation Therapy (3DCRT) to breast/chestwall and regional lymph nodes with treatment between 2000 and 2009."
11222604|NCT02348684|OG000|Outcome|Radiation Therapy Groups|"Risk groups based on dosimetric radiation parameters and eligibility criteria.~Radiation therapy groups: Radiation Therapy treatment between 2000 and 2009."
11222605|NCT02348684|EG000|Reported Event|Radiation Therapy Groups|"Risk groups based on dosimetric radiation parameters and eligibility criteria.~Radiation therapy groups: Radiation Therapy treatment between 2000 and 2009."
11222606|NCT02348723|BG000|Baseline|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
11222607|NCT02348723|BG001|Baseline|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
11222608|NCT02348723|BG002|Baseline|Total|Total of all reporting groups
11343694|NCT03927911|BG005|Baseline|Cohort 3 Control Group|Standard of Care
11343695|NCT03927911|BG006|Baseline|Total|Total of all reporting groups
11343696|NCT03927911|FG000|Participant Flow|Cohort 1:Open or Mini-open Surgical Technique|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11222609|NCT02348723|FG000|Participant Flow|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
11222610|NCT02348723|FG001|Participant Flow|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
11222611|NCT02348723|OG000|Outcome|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
11222612|NCT02348723|OG001|Outcome|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
11222613|NCT02348723|EG000|Reported Event|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
11222614|NCT02348723|EG001|Reported Event|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
11222615|NCT02348775|BG000|Baseline|Cysteine/Glycine|"8 HIV infected subjects were studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 3 months, and compared to 8 uninfected controls~Cysteine (as n-acetylcysteine) and glycine: Only HIV patients were studied before and after receiving cysteine and glycine"
11222616|NCT02348775|BG001|Baseline|No Supplements|8 uninfected participants served as controls and were not supplemented
11222617|NCT02348775|BG002|Baseline|Total|Total of all reporting groups
11222618|NCT02348775|FG000|Participant Flow|GlyNAC|8 HIV infected subjects were studied before and after receiving GlyNAC (combination of glycine and n-acetylcysteine) for 12-weeks
11222619|NCT02348775|FG001|Participant Flow|Control Arm|This comprised of 8 participants not known to have HIV, and did not receive GlyNAC
11343697|NCT03927911|FG001|Participant Flow|Cohort 1 Control Group|Standard of Care
10976358|NCT00940108|FG000|Participant Flow|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
11222620|NCT02348775|OG000|Outcome|GlyNAC|8 HIV infected subjects were studied before and after receiving oral GlyNAC (glycine plus n-acetylcysteine) for 12-weeks
11222621|NCT02348775|OG001|Outcome|Control Arm|This comprised of 8 participants not known to have HIV, and did not receive GlyNAC
11222622|NCT02348775|EG000|Reported Event|GlyNAC Arm|HIV infected subjects will be studied before and after taking GlyNAC for 12-weeks
11343698|NCT03927911|FG002|Participant Flow|Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort)|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11343699|NCT03927911|FG003|Participant Flow|Cohort 2 Control Group|Standard of Care
11222623|NCT02348775|EG001|Reported Event|Control Arm|Controls will be HIV negative and not receive GlyNAC
11222624|NCT02348840|BG000|Baseline|TBA - Early Access Arm|Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months
11222625|NCT02348840|BG001|Baseline|TBA - Later Access Arm|Traditional birth attendants (TBAs) without access to mHealth technology for the first half of the study who then used mHealth for the remaining time of the 12 month study period
11222626|NCT02348840|BG002|Baseline|Pregnant Women - Early Access Arm|Pregnant women under the care of traditional birth attendants in the early access arm, who completed their pregnancy during the study period
11222627|NCT02348840|BG003|Baseline|Pregnant Women - Later Access Arm|Pregnant women under the care of traditional birth attendants in the later access arm, who completed their pregnancy during the study period
11222628|NCT02348840|BG004|Baseline|Total|Total of all reporting groups
11222629|NCT02348840|FG000|Participant Flow|TBA - Early Access Arm|Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months
11222630|NCT02348840|FG001|Participant Flow|TBA - Later Access Arm|Traditional birth attendants (TBAs) without access to mHealth technology for the first half of the study who then used mHealth for the remaining time of the 12 month study period
11222631|NCT02348840|FG002|Participant Flow|Pregnant Women - Early Access Arm|Pregnant women under the care of traditional birth attendants in the early access arm
11222632|NCT02348840|FG003|Participant Flow|Pregnant Women - Later Access Arm|Pregnant women under the care of traditional birth attendants in the later access arm
11222633|NCT02348840|OG000|Outcome|TBA - Early Access Arm|Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months
11222634|NCT02348840|OG001|Outcome|TBA - Later Access Arm|Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months
11222635|NCT02348840|OG000|Outcome|Pregnant Women - Early Access Arm|Pregnant women under the care of traditional birth attendants in the early access arm, who completed their pregnancy during the study period
11222636|NCT02348840|OG001|Outcome|Pregnant Women - Later Access Arm|Pregnant women under the care of traditional birth attendants in the later access arm, who completed their pregnancy during the study period
11222637|NCT02348840|EG000|Reported Event|TBA - Early Access Arm|Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months
11222638|NCT02348840|EG001|Reported Event|TBA - Later Access Arm|Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months
11222639|NCT02348840|EG002|Reported Event|Pregnant Women - Early Access Arm|Pregnant women under the care of traditional birth attendants in the early access arm, who completed their pregnancy during the study period
11222640|NCT02348840|EG003|Reported Event|Pregnant Women - Later Access Arm|Pregnant women under the care of traditional birth attendants in the later access arm, who completed their pregnancy during the study period
11343700|NCT03927911|FG004|Participant Flow|Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort)|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
10855109|NCT00326781|BG001|Baseline|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
11222641|NCT02348918|BG000|Baseline|Luminate 1.0mg Group|"Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 1.0mg"
10855110|NCT00326781|BG002|Baseline|Total|Total of all reporting groups
10855111|NCT00326781|FG000|Participant Flow|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
10855112|NCT00326781|FG001|Participant Flow|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
10855113|NCT00326781|OG000|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
10855114|NCT00326781|OG001|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
10855115|NCT00326781|EG000|Reported Event|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
10855116|NCT00326781|EG001|Reported Event|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
10855117|NCT00326872|BG000|Baseline|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
10855118|NCT00326872|FG000|Participant Flow|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
10855119|NCT00326872|OG000|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
10855120|NCT00326872|EG000|Reported Event|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
10855121|NCT00326885|BG000|Baseline|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
10855122|NCT00326885|FG000|Participant Flow|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
10855123|NCT00326885|OG000|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
10855124|NCT00326885|OG000|Outcome|Full Analysis Set|
10855125|NCT00326885|EG000|Reported Event|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
10855126|NCT00326911|BG000|Baseline|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
10855127|NCT00326911|BG001|Baseline|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
10855128|NCT00326911|BG002|Baseline|Total|Total of all reporting groups
11343701|NCT03927911|FG005|Participant Flow|Cohort 3 Control Group|Standard of Care
10855129|NCT00326911|FG000|Participant Flow|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
10855130|NCT00326911|FG001|Participant Flow|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
10855131|NCT00326911|OG000|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
10855132|NCT00326911|OG001|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
11222642|NCT02348918|BG001|Baseline|Luminate 2.0mg Group|"Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 2.0mg"
11222643|NCT02348918|BG002|Baseline|Luminate 3.0mg Group|"Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 3.0mg"
11222644|NCT02348918|BG003|Baseline|Avastin® Group|"Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.~Avastin"
11222645|NCT02348918|BG004|Baseline|Avastin Then Luminate 1.0 mg IVT + Sham Injection|"Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT~Luminate 1.0mg~Avastin"
11222646|NCT02348918|BG005|Baseline|Avastin Then Luminate 0.5 mg IVT + Sham Injection|"Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT~Avastin~Luminate 0.5mg"
11222647|NCT02348918|BG006|Baseline|Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT|"Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT~Luminate 1.0mg~Avastin"
10855133|NCT00326911|EG000|Reported Event|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
11222648|NCT02348918|BG007|Baseline|Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT|"Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT~Avastin~Luminate 0.5mg"
11222649|NCT02348918|BG008|Baseline|Avastin 1.25 mg + Sham IVT|"Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN~Luminate 0.5mg"
11222650|NCT02348918|BG009|Baseline|Total|Total of all reporting groups
11222651|NCT02348918|FG000|Participant Flow|Luminate 1.0mg Group|"Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 1.0mg"
11222652|NCT02348918|FG001|Participant Flow|Luminate 2.0mg Group|"Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 2.0mg"
11343702|NCT03927911|OG000|Outcome|Cohort 1:Open or Mini-open Surgical Technique|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11343703|NCT03927911|OG001|Outcome|Cohort 1 Control Group|Standard of Care
11343704|NCT03927911|OG002|Outcome|Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort)|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11343705|NCT03927911|OG003|Outcome|Cohort 2 Control Group|Standard of Care
11222653|NCT02348918|FG002|Participant Flow|Luminate 3.0mg Group|"Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 3.0mg"
11222654|NCT02348918|FG003|Participant Flow|Avastin® Group|"Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.~Avastin"
11222655|NCT02348918|FG004|Participant Flow|Avastin Then Luminate 1.0 mg IVT + Sham Injection|"Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT~Luminate 1.0mg~Avastin"
11222656|NCT02348918|FG005|Participant Flow|Avastin Then Luminate 0.5 mg IVT + Sham Injection|"Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT~Avastin~Luminate 0.5mg"
11222657|NCT02348918|FG006|Participant Flow|Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT|"Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT~Luminate 1.0mg~Avastin"
11222658|NCT02348918|FG007|Participant Flow|Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT|"Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT~Avastin~Luminate 0.5mg"
11222659|NCT02348918|FG008|Participant Flow|Avastin 1.25 mg + Sham IVT|"Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN~Luminate 0.5mg"
11222660|NCT02348918|OG000|Outcome|Luminate 1.0mg Group|"Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 1.0mg"
11222661|NCT02348918|OG001|Outcome|Luminate 2.0mg Group|"Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 2.0mg"
11222662|NCT02348918|OG002|Outcome|Luminate 3.0mg Group|"Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 3.0mg"
11222663|NCT02348918|OG003|Outcome|Avastin® Group|"Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.~Avastin"
11222664|NCT02348918|OG004|Outcome|Avastin Then Luminate 1.0 mg IVT + Sham Injection|"Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT~Luminate 1.0mg~Avastin"
11222665|NCT02348918|OG005|Outcome|Avastin Then Luminate 0.5 mg IVT + Sham Injection|"Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT~Avastin~Luminate 0.5mg"
11343706|NCT03927911|OG004|Outcome|Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort)|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11222666|NCT02348918|OG006|Outcome|Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT|"Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT~Luminate 1.0mg~Avastin"
11222667|NCT02348918|OG007|Outcome|Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT|"Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT~Avastin~Luminate 0.5mg"
11222668|NCT02348918|OG008|Outcome|Avastin 1.25 mg + Sham IVT|"Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN~Luminate 0.5mg"
11222669|NCT02348918|EG000|Reported Event|Luminate 1.0mg Group|"Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 1.0mg"
11222670|NCT02348918|EG001|Reported Event|Luminate 2.0mg Group|"Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 2.0mg"
11222671|NCT02348918|EG002|Reported Event|Luminate 3.0mg Group|"Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.~Luminate 3.0mg"
11222672|NCT02348918|EG003|Reported Event|Avastin® Group|"Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.~Avastin"
11222673|NCT02348918|EG004|Reported Event|Avastin Then Luminate 1.0 mg IVT + Sham Injection|"Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT~Luminate 1.0mg~Avastin"
11343707|NCT03927911|OG005|Outcome|Cohort 3 Control Group|Standard of Care
11222674|NCT02348918|EG005|Reported Event|Avastin Then Luminate 0.5 mg IVT + Sham Injection|"Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT~Avastin~Luminate 0.5mg"
11222675|NCT02348918|EG006|Reported Event|Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT|"Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT~Luminate 1.0mg~Avastin"
11222676|NCT02348918|EG007|Reported Event|Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT|"Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT~Avastin~Luminate 0.5mg"
11222677|NCT02348918|EG008|Reported Event|Avastin 1.25 mg + Sham IVT|"Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN~Luminate 0.5mg"
11222678|NCT02349048|BG000|Baseline|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
11222679|NCT02349048|BG001|Baseline|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
11222680|NCT02349048|BG002|Baseline|Total|Total of all reporting groups
11222681|NCT02349048|FG000|Participant Flow|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
11222682|NCT02349048|FG001|Participant Flow|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
11222683|NCT02349048|OG000|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
11222684|NCT02349048|OG001|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
11222685|NCT02349048|EG000|Reported Event|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
10855134|NCT00326911|EG001|Reported Event|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
10855135|NCT00326924|BG000|Baseline|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
11222686|NCT02349048|EG001|Reported Event|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
11222687|NCT02349061|BG000|Baseline|Placebo - Ustekinumab|Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16. At Week 24, participants who completed were crossed-over to receive ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
11222688|NCT02349061|BG001|Baseline|Ustekinumab|Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16. Participants who completed placebo controlled period (PCP) continued to receive ustekinumab 90 mg at Weeks 24, 32, and 40 followed by safety follow-up for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
11222689|NCT02349061|BG002|Baseline|Total|Total of all reporting groups
11222690|NCT02349061|FG000|Participant Flow|Placebo - Ustekinumab|Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16. At Week 24, participants who completed were crossed-over to receive ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
11222691|NCT02349061|FG001|Participant Flow|Ustekinumab|Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16. Participants who completed placebo controlled period (PCP) continued to receive ustekinumab 90 mg at Weeks 24, 32, and 40 followed by safety follow-up for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
11222692|NCT02349061|FG002|Participant Flow|Placebo to Ustekinumab|Participants who received placebo matched to ustekinumab and completed PCP period in placebo group were crossed-over at Week 24 and received ustekinumab 90 mg SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
11222693|NCT02349061|OG000|Outcome|Placebo|Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
11222694|NCT02349061|OG001|Outcome|Ustekinumab|Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
11222695|NCT02349061|EG000|Reported Event|Placebo (Up to Week 24)|Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
11222696|NCT02349061|EG001|Reported Event|Ustekinumab (Up to Week 24)|Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Week 8 and 16.
11222697|NCT02349061|EG002|Reported Event|Placebo to Ustekinumab (Week 24 to 56)|Participants who received placebo matched to ustekinumab and completed placebo controlled period (PCP) in placebo group were crossed-over at Week 24 and received ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
11222698|NCT02349061|EG003|Reported Event|Ustekinumab (Week 24 to 56)|Participants who were assigned to Ustekinumab treatment and who completed PCP continued to receive ustekinumab 90 mg SC at Weeks 24, 32, and 40 followed by safety follow up for 16 weeks after last study agent SC administration.
11222699|NCT02349061|EG004|Reported Event|Placebo to Ustekinumab (Week 56 to 120)|Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
11222700|NCT02349061|EG005|Reported Event|Ustekinumab (Week 56 to 120)|Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
11222701|NCT02349152|BG000|Baseline|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
11222702|NCT02349152|BG001|Baseline|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
11222703|NCT02349152|BG002|Baseline|Total|Total of all reporting groups
11222704|NCT02349152|FG000|Participant Flow|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
11222705|NCT02349152|FG001|Participant Flow|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
11222706|NCT02349152|OG000|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
11222707|NCT02349152|OG001|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
10976359|NCT00940108|FG001|Participant Flow|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
11222708|NCT02349152|EG000|Reported Event|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
11222709|NCT02349152|EG001|Reported Event|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
11222710|NCT02349178|BG000|Baseline|Bridging Arm|"Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion~Clofarabine: Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours~Cyclophosphamide: Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion~Etoposide: Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours"
11222711|NCT02349178|FG000|Participant Flow|Bridging Arm|"Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion~Clofarabine: Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours~Cyclophosphamide: Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion~Etoposide: Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours"
11222712|NCT02349178|OG000|Outcome|Bridging Arm|"Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion~Clofarabine: Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours~Cyclophosphamide: Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion~Etoposide: Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours"
11343708|NCT03927911|EG000|Reported Event|Cohort 1:Open or Mini-open Surgical Technique|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11222713|NCT02349178|EG000|Reported Event|Bridging Arm|"Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion~Clofarabine: Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours~Cyclophosphamide: Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion~Etoposide: Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours"
11222714|NCT02349295|BG000|Baseline|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
11222715|NCT02349295|BG001|Baseline|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
11222716|NCT02349295|BG002|Baseline|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
11222717|NCT02349295|BG003|Baseline|Total|Total of all reporting groups
11222718|NCT02349295|FG000|Participant Flow|Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period|Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.
11222719|NCT02349295|FG001|Participant Flow|Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.
11222720|NCT02349295|FG002|Participant Flow|Placebo (PBO) - Blinded Treatment Period|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.
11222721|NCT02349295|FG003|Participant Flow|Ixe 80 mg Q2W - Blinded Treatment Period IR|Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
11222722|NCT02349295|FG004|Participant Flow|Ixe 80 mg Q4W - Blinded Treatment Period IR|Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.
11222723|NCT02349295|FG005|Participant Flow|PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR|Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.
11222724|NCT02349295|FG006|Participant Flow|PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR|Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.
11343709|NCT03927911|EG001|Reported Event|Cohort 1 Control Group|Standard of Care for open or mini-open surgical technique cohort
11343710|NCT03927911|EG002|Reported Event|Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort)|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
11343711|NCT03927911|EG003|Reported Event|Cohort 2 Control Group|Standard of Care for Tubular or Percutaneous Cohort (Minimally Invasive Cohort)
10976360|NCT00940108|FG002|Participant Flow|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
11222725|NCT02349295|FG007|Participant Flow|Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period|Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.
11222726|NCT02349295|FG008|Participant Flow|Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period|Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
11222727|NCT02349295|FG009|Participant Flow|Placebo/ Ixe 80 mg Q2W - Extended Treatment Period|"Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.~Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.~Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16."
11336517|NCT03567382|FG001|Participant Flow|Low-risk Mothers|"Mothers with low risk HBV (defined as a viral load <10^6 and negative HBeAg) will not receive tenofovir disoproxil fumarate therapy during or after pregnancy. Their infants will still receive monovalent HBV vaccine within 24 hours of life.~Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life."
11222728|NCT02349295|FG010|Participant Flow|Placebo/ Ixe 80 mg Q4W - Extended Treatment Period|"Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.~Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.~Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16."
11222729|NCT02349295|FG011|Participant Flow|Ixe 80 mg Q2W - Post Treatment Follow-Up Period|Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
11222730|NCT02349295|FG012|Participant Flow|Ixe 80 mg Q4W - Post Treatment Follow-Up Period|Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
11222731|NCT02349295|FG013|Participant Flow|PBO - Post Treatment Follow-Up Period|Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
11222732|NCT02349295|OG000|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
11222733|NCT02349295|OG001|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
11343712|NCT03927911|EG004|Reported Event|Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort)|"Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort~EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5%~Standard of Care: Standard of Care"
10855136|NCT00326924|BG001|Baseline|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
10855137|NCT00326924|BG002|Baseline|Total|Total of all reporting groups
10855138|NCT00326924|FG000|Participant Flow|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
10855139|NCT00326924|FG001|Participant Flow|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
10855140|NCT00326924|OG000|Outcome|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
10855141|NCT00326924|OG001|Outcome|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
10855142|NCT00326924|EG000|Reported Event|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
11222734|NCT02349295|OG002|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
11222735|NCT02349295|OG000|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
10855143|NCT00326924|EG001|Reported Event|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
10855144|NCT00326950|BG000|Baseline|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
10855145|NCT00326950|FG000|Participant Flow|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
10855146|NCT00326950|OG000|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
10855147|NCT00326950|EG000|Reported Event|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
10855148|NCT00326963|BG000|Baseline|Enfuvirtide+PI+ARV's|"Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½ needle/syringe, 31G 8 mm needle/syringe or B2000 NFID."
11336518|NCT03567382|FG002|Participant Flow|Infants Born to High-risk Mothers|Infants born to mothers with high-risk HBV
11343713|NCT03927911|EG005|Reported Event|Cohort 3 Control Group|Standard of Care for Limbar decompression without fusion (Outpatient Cohort)
10976361|NCT00940108|FG003|Participant Flow|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976362|NCT00940108|OG000|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976363|NCT00940108|OG001|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
11222736|NCT02349295|OG001|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
11222737|NCT02349295|OG000|Outcome|Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period|Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.
11222738|NCT02349295|OG001|Outcome|Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period|Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
11222739|NCT02349295|OG002|Outcome|Placebo/ Ixe 80 mg Q2W - Extended Treatment Period|"Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.~Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.~Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16."
11222740|NCT02349295|OG003|Outcome|Placebo/ Ixe 80 mg Q4W - Extended Treatment Period|"Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.~Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.~Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16."
11222741|NCT02349295|EG000|Reported Event|Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period|Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.
11222742|NCT02349295|EG001|Reported Event|Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.
11222743|NCT02349295|EG002|Reported Event|Placebo (PBO) - Blinded Treatment Period|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.
11222744|NCT02349295|EG003|Reported Event|Ixe 80 mg Q2W - Blinded Treatment Period IR|Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
11222745|NCT02349295|EG004|Reported Event|Ixe 80 mg Q4W - Blinded Treatment Period IR|Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.
11222746|NCT02349295|EG005|Reported Event|PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR|Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.
11222747|NCT02349295|EG006|Reported Event|PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR|Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.
11222748|NCT02349295|EG007|Reported Event|Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period|Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.
11222749|NCT02349295|EG008|Reported Event|Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period|Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
11222750|NCT02349295|EG009|Reported Event|Placebo/ Ixe 80 mg Q2W - Extended Treatment Period|"Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.~Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.~Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16."
11222751|NCT02349295|EG010|Reported Event|Placebo/ Ixe 80 mg Q4W - Extended Treatment Period|"Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.~Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.~Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16."
11222752|NCT02349295|EG011|Reported Event|Ixe 80 mg Q2W - Post Treatment Follow-Up Period|Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
11222753|NCT02349295|EG012|Reported Event|Ixe 80 mg Q4W - Post Treatment Follow-Up Period|Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
11222754|NCT02349295|EG013|Reported Event|PBO - Post Treatment Follow-Up Period|Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
11222755|NCT02349360|BG000|Baseline|Probiotic|"L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks"
11222756|NCT02349360|BG001|Baseline|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
11222757|NCT02349360|BG002|Baseline|Total|Total of all reporting groups
11222758|NCT02349360|FG000|Participant Flow|Probiotic|"L. johnsonii N6.2 in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 in capsule form administered for 8 weeks"
11222759|NCT02349360|FG001|Participant Flow|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
11222760|NCT02349360|OG000|Outcome|Probiotic|"L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks ("
11222761|NCT02349360|OG001|Outcome|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
11222762|NCT02349360|EG000|Reported Event|Probiotic|"L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks"
11222763|NCT02349360|EG001|Reported Event|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
11348495|NCT04157738|BG001|Baseline|Insulin to Carbohydrate Ratio (ICR) Group|"Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen~Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)~Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)"
10976364|NCT00940108|OG002|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976365|NCT00940108|OG003|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976366|NCT00940108|EG000|Reported Event|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976367|NCT00940108|EG001|Reported Event|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976368|NCT00940108|EG002|Reported Event|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
11222764|NCT02349412|BG000|Baseline|Arm 1 (Early Palliative Care)|Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
11222765|NCT02349412|BG001|Baseline|Arm 2 (Usual Care)|Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
11222766|NCT02349412|BG002|Baseline|Total|Total of all reporting groups
11222767|NCT02349412|FG000|Participant Flow|Arm 1 (Early Palliative Care)|Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
11222768|NCT02349412|FG001|Participant Flow|Arm 2 (Usual Care)|Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
11222769|NCT02349412|OG000|Outcome|Arm 1 (Early Palliative Care)|Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
11222770|NCT02349412|OG001|Outcome|Arm 2 (Usual Care)|Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
11222771|NCT02349412|EG000|Reported Event|Arm 1 (Early Palliative Care)|Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
11222772|NCT02349412|EG001|Reported Event|Arm 2 (Usual Care)|Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
11336519|NCT03567382|FG003|Participant Flow|Infants Born to Low-risk Mothers|Infants born to mothers with low-risk HBV
11222773|NCT02349425|BG000|Baseline|Cohort 1 - Gefapixant>Placebo|Gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7-day washout period between treatment periods.
11222774|NCT02349425|BG001|Baseline|Cohort 1 - Placebo>Gefalixant|Placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.
11222775|NCT02349425|BG002|Baseline|Cohort 2 - Gefapixant>Placebo|Gefapixant 7.5, 15, 30 and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 7.5, 15, 30 and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 2, there was a 14 to 21-day washout period between treatment periods.
11222776|NCT02349425|BG003|Baseline|Cohort 2 - Placebo>Gefapixant|Placebo to gefapixant 7.5, 15, 30 and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and gefapixant 7.5, 15, 30 and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 2, there was a 14 to 21-day washout period between treatment periods.
11222777|NCT02349425|BG004|Baseline|Total|Total of all reporting groups
11222778|NCT02349425|FG000|Participant Flow|Cohort 1: Gefapixant>Placebo|Gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.
11222779|NCT02349425|FG001|Participant Flow|Cohort 1: Placebo>Gefapixant|Placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.
11222780|NCT02349425|FG002|Participant Flow|Cohort 2: Gefapixant>Placebo|Gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth twice daily for 4 days each in Period 2. For Cohort 2 there was a 14-21 day washout period between treatment periods.
11222781|NCT02349425|FG003|Participant Flow|Cohort 2: Placebo>Gefapixant|Placebo to gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth twice daily for 4 days each in Period 1 and gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 2 there was a 14-21 day washout period between treatment periods.
11222782|NCT02349425|OG000|Outcome|Cohort 1 - Gefapixant 50 mg|Gefapixant 50 mg tablet administered by mouth BID for 4 days.
11222783|NCT02349425|OG001|Outcome|Cohort 1 - Placebo for Gefapixant 50 mg|Placebo tablet administered by mouth BID for 4 days.
11222784|NCT02349425|OG002|Outcome|Cohort 1 - Gefapixant 100 mg|Gefapixant 100 mg tablet administered by mouth BID for 4 days.
11222785|NCT02349425|OG003|Outcome|Cohort 1 - Placebo for Gefapixant 100 mg|Placebo tablet administered by mouth BID for 4 days.
11222786|NCT02349425|OG004|Outcome|Cohort 1 - Gefapixant 150 mg|Gefapixant 150 mg tablet administered by mouth BID for 4 days.
11222787|NCT02349425|OG005|Outcome|Cohort 1 - Placebo for Gefapixant 150 mg|Placebo tablet administered by mouth BID for 4 days.
11222788|NCT02349425|OG006|Outcome|Cohort 1 - Gefapixant 200 mg|Gefapixant 200 mg tablet administered by mouth BID for 4 days.
11222789|NCT02349425|OG007|Outcome|Cohort 1 - Placebo for Gefapixant 200 mg|Placebo tablet administered by mouth BID for 4 days.
11222790|NCT02349425|OG000|Outcome|Cohort 2 - Gefapixant 7.5 mg|Gefapixant 7.5 mg tablet administered by mouth BID for 4 days.
11222791|NCT02349425|OG001|Outcome|Cohort 2 - Placebo for Gefapixant 7.5 mg|Placebo tablet administered by mouth BID for 4 days.
11222792|NCT02349425|OG002|Outcome|Cohort 2 - Gefapixant 15 mg|Gefapixant 15 mg tablet administered by mouth BID for 4 days.
11222793|NCT02349425|OG003|Outcome|Cohort 2 - Placebo for Gefapixant 15 mg|Placebo tablet administered by mouth BID for 4 days.
11222794|NCT02349425|OG004|Outcome|Cohort 2 - Gefapixant 30 mg|Gefapixant 30 mg tablet administered by mouth BID for 4 days.
11222795|NCT02349425|OG005|Outcome|Cohort 2 - Placebo for Gefapixant 30 mg|Placebo tablet administered by mouth BID for 4 days.
11222796|NCT02349425|OG006|Outcome|Cohort 2 - Gefapixant 50 mg|Gefapixant 50 mg tablet administered by mouth BID for 4 days.
11222797|NCT02349425|OG007|Outcome|Cohort 2 - Placebo for Gefapixant 50 mg|Placebo tablet administered by mouth BID for 4 days.
11222798|NCT02349425|OG001|Outcome|Cohort 1' - Placebo for Gefapixant 50 mg|Placebo tablet administered by mouth BID for 4 days.
11222799|NCT02349425|OG007|Outcome|Cohort 2 - Placebo for Gefapixant 50 mg|Placebo tablets administered by mouth BID for 4 days.
11222800|NCT02349425|OG001|Outcome|Cohort 2 - Placebo for Gefapixant 7.5 mg|Placebo tablet administered by mouth BID for 4 days. .
11222801|NCT02349425|OG003|Outcome|Cohort 1 - Placebo for Gefapixant 15 mg|Placebo tablet administered by mouth BID for 4 days.
11222802|NCT02349425|OG000|Outcome|Cohort 1 - Gefapixant|Gefapixant 50, 100, 150, and 200 mg tablet(s) administered by mouth BID for 4 days each.
11222803|NCT02349425|OG001|Outcome|Cohort 1 - Placebo|Placebo tablet administered by mouth BID for 4 days.
11222804|NCT02349425|OG002|Outcome|Cohort 2 - Gefapixant|Gefapixant 7.5, 15, 30, and 50 mg tablet(s) administered by mouth BID for 4 days each.
11222805|NCT02349425|OG003|Outcome|Cohort 2 - Placebo|Placebo tablet administered by mouth BID for 4 days each.
11222806|NCT02349425|OG003|Outcome|Cohort 1 - Placebo for Gefapixant 50 mg|Placebo tablet administered by mouth BID for 4 days.
11222807|NCT02349425|OG003|Outcome|Cohort 2 - Placebo|Placebo tablet administered by BID daily for 4 days each.
11222808|NCT02349425|EG000|Reported Event|Cohort 1: Gefapixant 50 mg|Gefapixant 50 mg tablet administered by mouth twice daily (BID) for 4 days.
11222809|NCT02349425|EG001|Reported Event|Cohort 1: Gefapixant 100 mg|Gefapixant 100 mg tablet administered by mouth BID or 4 days.
11222810|NCT02349425|EG002|Reported Event|Cohort 1 - Gefapixant 150 mg|Gefapixant 150 mg tablet administered by mouth BID for 4 days.
11222811|NCT02349425|EG003|Reported Event|Cohort 1: Gefapixant 200 mg|Gefapixant 200 mg tablet administered by mouth BID for 4 days.
11348496|NCT04157738|BG002|Baseline|Total|Total of all reporting groups
11222812|NCT02349425|EG004|Reported Event|Cohort 1 - Placebo|Placebo tablet administered by mouth BID for 4 days each.
11222813|NCT02349425|EG005|Reported Event|Cohort 2 - Gefapixant 7.5 mg|Gefapixant 7.5 mg tablet administered by mouth BID for 4 days.
11222814|NCT02349425|EG006|Reported Event|Cohort 2 - Gefapixant 15 mg|Gefapixant 15 mg tablet administered by mouth BID for 4 days.
11222815|NCT02349425|EG007|Reported Event|Cohort 2 - Gefapixant 30 mg|Gefapixant 30 mg tablet administered by mouth BID for 4 days.
11222816|NCT02349425|EG008|Reported Event|Cohort 2 - Gefapixant 50 mg|Gefapixant 50 mg tablet administered by mouth BID for 4 days.
11222817|NCT02349425|EG009|Reported Event|Cohort 2- Placebo|Placebo tablet administered by mouth BID for 4 days each.
11222818|NCT02349438|BG000|Baseline|Dispensed|All subjects that were dispensed at least 1 study lens during the course of the study.
11222819|NCT02349438|FG000|Participant Flow|Senofilcon A/Lotrafilcon B|Subjects that were randomized to receive the senofilcon A lens first and then to receive the lotrafilcon B lens.
11222820|NCT02349438|FG001|Participant Flow|Lotrafilcon B/Senofilcon A|Subjects that were randomized to receive the lotrafilcon B lens first and then to receive the senofilcon A lens.
11222821|NCT02349438|OG000|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
11222822|NCT02349438|OG001|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
11222823|NCT02349438|EG000|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
11222824|NCT02349438|EG001|Reported Event|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
11222825|NCT02349451|BG000|Baseline|Placebo EW|Double-blind placebo administered EW for 12 weeks
11222826|NCT02349451|BG001|Baseline|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
11222827|NCT02349451|BG002|Baseline|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
11222828|NCT02349451|BG003|Baseline|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
11222829|NCT02349451|BG004|Baseline|Total|Total of all reporting groups
11222830|NCT02349451|FG000|Participant Flow|Placebo EW|Double-blind placebo administered every week (EW) for 12 weeks
11222831|NCT02349451|FG001|Participant Flow|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks
11222832|NCT02349451|FG002|Participant Flow|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
11222833|NCT02349451|FG003|Participant Flow|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
11222834|NCT02349451|OG000|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
11222835|NCT02349451|OG001|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
11222836|NCT02349451|OG002|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
11222837|NCT02349451|OG000|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
11222838|NCT02349451|OG001|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
11222839|NCT02349451|OG002|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
11222840|NCT02349451|OG003|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
11222841|NCT02349451|EG000|Reported Event|Placebo EW|Double-blind placebo administered EW for 12 weeks
11222842|NCT02349451|EG001|Reported Event|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
11222843|NCT02349451|EG002|Reported Event|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
11222844|NCT02349451|EG003|Reported Event|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
11222845|NCT02349477|BG000|Baseline|Gabapentin|"Gabapentin up to 1200 mg per day in 3 divided doses~Gabapentin: gaba potentiating medication"
11222846|NCT02349477|BG001|Baseline|Placebo|"matching placebo~Placebo: a pill that looks exactly like the active medication but does not contain medication"
11222847|NCT02349477|BG002|Baseline|Total|Total of all reporting groups
11222848|NCT02349477|FG000|Participant Flow|Gabapentin|"Gabapentin up to 1200 mg per day in 3 divided doses~Gabapentin: gaba potentiating medication"
11222849|NCT02349477|FG001|Participant Flow|Placebo|"matching placebo~Placebo: a pill that looks exactly like the active medication but does not contain medication"
11222850|NCT02349477|OG000|Outcome|Gabapentin|"Gabapentin up to 1200 mg per day in 3 divided doses~Gabapentin: gaba potentiating medication"
11222851|NCT02349477|OG001|Outcome|Placebo|"matching placebo~Placebo: a pill that looks exactly like the active medication but does not contain medication"
11222852|NCT02349477|OG000|Outcome|Low AWS/Gabapentin|Low on AWS median split variable, Gabapentin
11222853|NCT02349477|OG001|Outcome|Low AWS/Placebo|Low on AWS median split variable, Placebo
11222854|NCT02349477|OG002|Outcome|High AWS/Gabapentin|High on AWS median split variable, Gabapentin
11222855|NCT02349477|OG003|Outcome|High AWS/Placebo|High on AWS median split variable, Placebo
11222856|NCT02349477|EG000|Reported Event|Gabapentin|"Gabapentin up to 1200 mg per day in 3 divided doses~Gabapentin: gaba potentiating medication"
11222857|NCT02349477|EG001|Reported Event|Placebo|"matching placebo~Placebo: a pill that looks exactly like the active medication but does not contain medication"
11222858|NCT02349542|BG000|Baseline|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
11222859|NCT02349542|FG000|Participant Flow|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
11343714|NCT03937570|BG000|Baseline|EO GROUP|"Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.~echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device."
11343715|NCT03937570|BG001|Baseline|CONTROL GROUP|Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
11343716|NCT03937570|BG002|Baseline|Total|Total of all reporting groups
11343717|NCT03937570|FG000|Participant Flow|EO GROUP|"Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.~echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device."
11343718|NCT03937570|FG001|Participant Flow|CONTROL GROUP|Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
11343719|NCT03937570|OG000|Outcome|EO GROUP|"Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.~echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device."
11343720|NCT03937570|OG001|Outcome|CONTROL GROUP|Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
11343721|NCT03937570|EG000|Reported Event|EO GROUP|"Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.~echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device."
11343722|NCT03937570|EG001|Reported Event|CONTROL GROUP|Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
11343723|NCT03938857|BG000|Baseline|Fen. SOC+Saline Placebo (Bolus+Infusion)|"Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)~Fentanyl: Fentanyl standard of care"
11343724|NCT03938857|BG001|Baseline|Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)"
11343725|NCT03938857|BG002|Baseline|Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)"
11343726|NCT03938857|BG003|Baseline|Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)"
11343727|NCT03938857|BG004|Baseline|Total|Total of all reporting groups
11343728|NCT03938857|FG000|Participant Flow|Fen. SOC+Saline Placebo (Bolus+Infusion)|"Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)~Fentanyl: Fentanyl standard of care"
11343729|NCT03938857|FG001|Participant Flow|Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)"
11343730|NCT03938857|FG002|Participant Flow|Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)"
11343731|NCT03938857|FG003|Participant Flow|Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)"
10976369|NCT00940108|EG003|Reported Event|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
10976370|NCT00940290|BG000|Baseline|GRADE System|A clinical recommendation built and graded with the GRADE working group system
11343732|NCT03938857|OG000|Outcome|Fen. SOC+Saline Placebo (Bolus+Infusion)|"Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)~Fentanyl: Fentanyl standard of care"
11343733|NCT03938857|OG001|Outcome|Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)"
11343734|NCT03938857|OG002|Outcome|Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)"
11343735|NCT03938857|OG003|Outcome|Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)"
11343736|NCT03938857|EG000|Reported Event|Fen. SOC+Saline Placebo (Bolus+Infusion)|"Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)~Fentanyl: Fentanyl standard of care"
11343737|NCT03938857|EG001|Reported Event|Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)"
11343738|NCT03938857|EG002|Reported Event|Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)"
11343739|NCT03938857|EG003|Reported Event|Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)|"Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)~Fentanyl: Fentanyl standard of care~Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)"
11343740|NCT03941912|BG000|Baseline|Erchonia EVRL|"635 nanometers (nm) and 405 nm dual-diode laser application~Erchonia EVRL: Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red diode light and 405 nm violet diode light simultaneously."
11343741|NCT03941912|FG000|Participant Flow|Erchonia EVRL|"635 nanometers (nm) and 405 nm dual-diode laser application~Erchonia EVRL: Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red diode light and 405 nm violet diode light simultaneously."
11343742|NCT03941912|OG000|Outcome|Erchonia EVRL|"635 nanometers (nm) and 405 nm dual-diode laser application~Erchonia EVRL: Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red diode light and 405 nm violet diode light simultaneously."
11343743|NCT03941912|EG000|Reported Event|Erchonia EVRL|"635 nanometers (nm) and 405 nm dual-diode laser application~Erchonia EVRL: Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red diode light and 405 nm violet diode light simultaneously."
10976371|NCT00940290|BG001|Baseline|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
10976372|NCT00940290|BG002|Baseline|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
11343744|NCT03945981|BG000|Baseline|DTG Plus 3TC|Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
10976373|NCT00940290|BG003|Baseline|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
10976374|NCT00940290|BG004|Baseline|Total|Total of all reporting groups
10976375|NCT00940290|FG000|Participant Flow|GRADE System|A clinical recommendation built and graded with the GRADE working group system
11343745|NCT03945981|FG000|Participant Flow|DTG Plus 3TC|Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
11343746|NCT03945981|OG000|Outcome|DTG Plus 3TC|Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
11343747|NCT03945981|EG000|Reported Event|DTG Plus 3TC|Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
11343748|NCT03950167|BG000|Baseline|Hyperemesis Gravidarum|pregnant women before 14 weeks of pregnancy diagnosed with hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal.
11343749|NCT03950167|BG001|Baseline|Healthy Pregnant Women|Healthy pregnant women before 14 weeks of pregnancy without hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal.
11343750|NCT03950167|BG002|Baseline|Total|Total of all reporting groups
11343751|NCT03950167|FG000|Participant Flow|Hyperemesis Gravidarum|pregnant women before 14 weeks of pregnancy diagnosed with hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal.
11343752|NCT03950167|FG001|Participant Flow|Healthy Pregnant Women|Healthy pregnant women before 14 weeks of pregnancy without hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal.
11343753|NCT03950167|OG000|Outcome|Hyperemesis Gravidarum|pregnant women before 14 weeks of pregnancy diagnosed with hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal.
11343754|NCT03950167|OG001|Outcome|Healthy Pregnant Women|Healthy pregnant women before 14 weeks of pregnancy without hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal.
11343755|NCT03950167|EG000|Reported Event|Hyperemesis Gravidarum|pregnant women before 14 weeks of pregnancy diagnosed with hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal.
11343756|NCT03950167|EG001|Reported Event|Healthy Pregnant Women|Healthy pregnant women before 14 weeks of pregnancy without hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal.
11343757|NCT03954834|BG000|Baseline|5 mg Tirzepatide|Participants received 5 mg of tirzepatide as subcutaneous injection once a week.
11343758|NCT03954834|BG001|Baseline|10 mg Tirzepatide|Participants received 10mg of tirzepatide as subcutaneous injection once a week.
11343759|NCT03954834|BG002|Baseline|15 mg Tirzepatide|Participants received 15mg of tirzepatide as subcutaneous injection once a week.
11343760|NCT03954834|BG003|Baseline|Placebo|Participants received placebo as subcutaneous injection once a week.
11343761|NCT03954834|BG004|Baseline|Total|Total of all reporting groups
11343762|NCT03954834|FG000|Participant Flow|5 mg Tirzepatide|Participants received 5 mg of tirzepatide as subcutaneous injection once a week.
11343763|NCT03954834|FG001|Participant Flow|10 mg Tirzepatide|Participants received 10mg of tirzepatide as subcutaneous injection once a week.
11343764|NCT03954834|FG002|Participant Flow|15 mg Tirzepatide|Participants received 15mg of tirzepatide as subcutaneous injection once a week.
11343765|NCT03954834|FG003|Participant Flow|Placebo|Participants received placebo as subcutaneous injection once a week.
11343766|NCT03954834|OG000|Outcome|5 mg Tirzepatide|Participants received 5 mg of tirzepatide as subcutaneous injection once a week.
11343767|NCT03954834|OG001|Outcome|10 mg Tirzepatide|Participants received 10mg of tirzepatide as subcutaneous injection once a week.
11343768|NCT03954834|OG002|Outcome|15 mg Tirzepatide|Participants received 15mg of tirzepatide as subcutaneous injection once a week.
11343769|NCT03954834|OG003|Outcome|Placebo|Participants received placebo as subcutaneous injection once a week.
11343770|NCT03954834|EG000|Reported Event|5 mg Tirzepatide|Participants received 5 mg of Tirzepatide as subcutaneous injection, once weekly.
11343771|NCT03954834|EG001|Reported Event|10 mg Tirzepatide|Participants received 10 mg of Tirzepatide as subcutaneous injection, once weekly.
11343772|NCT03954834|EG002|Reported Event|15 mg Tirzepatide|Participants received 15 mg of Tirzepatide as subcutaneous injection, once weekly.
11343773|NCT03954834|EG003|Reported Event|Placebo|Participants received placebo as subcutaneous injection, once weekly.
11343774|NCT03958071|BG000|Baseline|Nintedanib|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
11343775|NCT03958071|BG001|Baseline|Pirfenidone|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
11343776|NCT03958071|BG002|Baseline|Untreated|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
11343777|NCT03958071|BG003|Baseline|Total|Total of all reporting groups
11343778|NCT03958071|FG000|Participant Flow|Nintedanib|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
11343779|NCT03958071|FG001|Participant Flow|Pirfenidone|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
11343780|NCT03958071|FG002|Participant Flow|Untreated|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
11343781|NCT03958071|OG000|Outcome|Nintedanib|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
11343782|NCT03958071|OG001|Outcome|Pirfenidone|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
11343783|NCT03958071|OG002|Outcome|Untreated|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
11343784|NCT03958071|OG000|Outcome|Overall Population|Patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment, first prescribed Nintedanib or first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
11343785|NCT03958071|EG000|Reported Event|Nintedanib|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
11343786|NCT03958071|EG001|Reported Event|Pirfenidone|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
11343787|NCT03958071|EG002|Reported Event|Untreated|Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
11343788|NCT03961529|BG000|Baseline|Adult: 1% OPA-15406 Ointment|Twice daily
11343789|NCT03961529|BG001|Baseline|Pediatric: 0.3% OPA-15406 Ointment|Twice daily
11343790|NCT03961529|BG002|Baseline|Pediatric: 1% OPA-15406 Ointment|Twice daily
11343791|NCT03961529|BG003|Baseline|Total|Total of all reporting groups
11343792|NCT03961529|FG000|Participant Flow|Adult: 1% OPA-15406 Ointment|Twice daily
11343793|NCT03961529|FG001|Participant Flow|Pediatric: 0.3% OPA-15406 Ointment|Twice daily
11343794|NCT03961529|FG002|Participant Flow|Pediatric: 1% OPA-15406 Ointment|Twice daily
10976376|NCT00940290|FG001|Participant Flow|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
11343795|NCT03961529|OG000|Outcome|Adult: 1% OPA-15406 Ointment|Twice daily
11343796|NCT03961529|OG001|Outcome|Pediatric: 0.3% OPA-15406 Ointment|Twice daily
11343797|NCT03961529|OG002|Outcome|Pediatric: 1% OPA-15406 Ointment|Twice daily
11343798|NCT03961529|EG000|Reported Event|Adult: 1% OPA-15406 Ointment|Twice daily
11343799|NCT03961529|EG001|Reported Event|Pediatric: 0.3% OPA-15406 Ointment|Twice daily
11343800|NCT03961529|EG002|Reported Event|Pediatric: 1% OPA-15406 Ointment|Twice daily
11343801|NCT03968159|BG000|Baseline|Pimavanserin|Pimavanserin 34 mg administered orally as a single dose once daily
11343802|NCT03968159|BG001|Baseline|Placebo|Placebo tablets administered orally as a single dose once daily
10976377|NCT00940290|FG002|Participant Flow|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
11343803|NCT03968159|BG002|Baseline|Total|Total of all reporting groups
11343804|NCT03968159|FG000|Participant Flow|Pimavanserin|Pimavanserin 34 mg administered orally as a single dose once daily
11343805|NCT03968159|FG001|Participant Flow|Placebo|Placebo tablets administered orally as a single dose once daily
11343806|NCT03968159|OG000|Outcome|Pimavanserin|Pimavanserin 34 mg administered orally as a single dose once daily
11343807|NCT03968159|OG001|Outcome|Placebo|Placebo tablets administered orally as a single dose once daily
11343808|NCT03968159|EG000|Reported Event|Pimavanserin|Pimavanserin 34 mg administered orally as a single dose once daily
11343809|NCT03968159|EG001|Reported Event|Placebo|Placebo tablets administered orally as a single dose once daily
11343810|NCT03968965|BG000|Baseline|3D MvIGS|"One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance.~3D MvIGS Spine Navigation: The 7D Surgical MvIGS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. The surgical light containing the machine vision cameras is the sole luminaire during image guided surgery."
11343811|NCT03968965|BG001|Baseline|2D Fluoroscopy|"One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.~2D Fluoroscopy: Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality."
11343812|NCT03968965|BG002|Baseline|Total|Total of all reporting groups
11343813|NCT03968965|FG000|Participant Flow|3D MvIGS|"One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance.~3D MvIGS Spine Navigation: The 7D Surgical MvIGS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. The surgical light containing the machine vision cameras is the sole luminaire during image guided surgery."
11343814|NCT03968965|FG001|Participant Flow|2D Fluoroscopy|"One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.~2D Fluoroscopy: Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality."
11343815|NCT03968965|OG000|Outcome|3D MvIGS|"One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance.~3D MvIGS Spine Navigation: The 7D Surgical MvIGS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. The surgical light containing the machine vision cameras is the sole luminaire during image guided surgery."
11343816|NCT03968965|OG001|Outcome|2D Fluoroscopy|"One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.~2D Fluoroscopy: Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality."
11343817|NCT03968965|EG000|Reported Event|3D MvIGS|"One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance.~3D MvIGS Spine Navigation: The 7D Surgical MvIGS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. The surgical light containing the machine vision cameras is the sole luminaire during image guided surgery."
11343818|NCT03968965|EG001|Reported Event|2D Fluoroscopy|"One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.~2D Fluoroscopy: Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality."
11343819|NCT03970824|BG000|Baseline|CT-P17|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343820|NCT03970824|BG001|Baseline|US-licensed Humira|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343821|NCT03970824|BG002|Baseline|EU-approved Humira|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343822|NCT03970824|BG003|Baseline|Total|Total of all reporting groups
10855149|NCT00326963|FG000|Participant Flow|Enfuvirtide+PI+ARV's|"Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½ needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID)."
10855150|NCT00326963|OG000|Outcome|Enfuvirtide+PI+ARV's|"Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½ needle/syringe, 31G 8 mm needle/syringe or B2000 NFID."
11343823|NCT03970824|FG000|Participant Flow|CT-P17|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343824|NCT03970824|FG001|Participant Flow|US-licensed Humira|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343825|NCT03970824|FG002|Participant Flow|EU-approved Humira|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343826|NCT03970824|OG000|Outcome|CT-P17|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343827|NCT03970824|OG001|Outcome|US-licensed Humira|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343828|NCT03970824|OG002|Outcome|EU-approved Humira|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343829|NCT03970824|EG000|Reported Event|CT-P17|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343830|NCT03970824|EG001|Reported Event|US-licensed Humira|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343831|NCT03970824|EG002|Reported Event|EU-approved Humira|"a single subcutaneous (SC) injection via pre-filled syringe (PFS)~EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS"
11343832|NCT03978403|BG000|Baseline|ABDC|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose"
11343833|NCT03978403|BG001|Baseline|BCAD|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose"
11343834|NCT03978403|BG002|Baseline|CDBA|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose"
11343835|NCT03978403|BG003|Baseline|DACB|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose"
11343836|NCT03978403|BG004|Baseline|Total|Total of all reporting groups
11343837|NCT03978403|FG000|Participant Flow|ABDC|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose"
10976378|NCT00940290|FG003|Participant Flow|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
10976379|NCT00940290|OG000|Outcome|GRADE System|A clinical recommendation built and graded with the GRADE working group system
10976380|NCT00940290|OG001|Outcome|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
10976381|NCT00940290|OG002|Outcome|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
10976382|NCT00940290|OG003|Outcome|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
10976383|NCT00940290|EG000|Reported Event|GRADE System|A clinical recommendation built and graded with the GRADE working group system
10976384|NCT00940290|EG001|Reported Event|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
11343838|NCT03978403|FG001|Participant Flow|BCAD|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose"
11343839|NCT03978403|FG002|Participant Flow|CDBA|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose"
11343840|NCT03978403|FG003|Participant Flow|DACB|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose"
11343841|NCT03978403|OG000|Outcome|M207 3.8 mg (Sled)|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches"
11343842|NCT03978403|OG001|Outcome|M207 3.8 mg (MACAP)|"B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups"
11343843|NCT03978403|OG002|Outcome|M207 3.8 mg (MiniMac)|"C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups"
11343844|NCT03978403|OG003|Outcome|Zolmitriptan 2.5 mg (Intranasal)|D: Zolmitriptan intranasal 2.5 mg/0.1 mL single dose
11343845|NCT03978403|OG002|Outcome|M207 e.8 mg (MiniMac)|"C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups"
11343846|NCT03978403|EG000|Reported Event|M207 3.8 mg (Sled)|"A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a Sled coater and packaged in foil pouches"
11343847|NCT03978403|EG001|Reported Event|M207 3.8 mg (MACAP)|"B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a MACAP coater and packaged in foil cups"
11343848|NCT03978403|EG002|Reported Event|M207 3.8 mg (MiniMac)|"C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a miniMac coater and packaged in foil cups"
11343849|NCT03978403|EG003|Reported Event|Zolmitriptan 2.5 mg (Intranasal)|D: Zolmitriptan intranasal 2.5 mg/0.1 mL single dose
10976385|NCT00940290|EG002|Reported Event|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
10976386|NCT00940290|EG003|Reported Event|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
10976387|NCT00940316|BG000|Baseline|Arm A: Erlotinib + Panitumumab + Irinotecan|"Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype"
10976388|NCT00940316|BG001|Baseline|Arm B: Erlotinib + Panitumumab|"Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype"
10976389|NCT00940316|BG002|Baseline|Arm C: Erlotinib + Panitumumab|"Patients receive erlotinib hydrochloride and panitumumab as in arm B.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily"
10976390|NCT00940316|BG003|Baseline|Total|Total of all reporting groups
10976391|NCT00940316|FG000|Participant Flow|Arm A: Erlotinib + Panitumumab + Irinotecan|"Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype"
10976392|NCT00940316|FG001|Participant Flow|Arm B: Erlotinib + Panitumumab|"Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype"
10976393|NCT00940316|FG002|Participant Flow|Arm C: Erlotinib + Panitumumab|"Patients receive erlotinib hydrochloride and panitumumab as in arm B.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily"
11343850|NCT03979807|BG000|Baseline|Olodaterol/Tiotropium Bromide - Matched Cohort|Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018.
11343851|NCT03979807|BG001|Baseline|Umeclidinium/Vilanterol - Matched Cohort|Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018.
11343852|NCT03979807|BG002|Baseline|Total|Total of all reporting groups
11343853|NCT03979807|FG000|Participant Flow|Olodaterol/Tiotropium Bromide - Matched Cohort|Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018.
11343854|NCT03979807|FG001|Participant Flow|Umeclidinium/Vilanterol - Matched Cohort|Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018.
11343855|NCT03979807|OG000|Outcome|Olodaterol/Tiotropium Bromide - Matched Cohort|Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018.
11343856|NCT03979807|OG001|Outcome|Umeclidinium/Vilanterol - Matched Cohort|Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018.
11343857|NCT03979807|EG000|Reported Event|Olodaterol/Tiotropium Bromide - Matched Cohort|Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018.
11343858|NCT03979807|EG001|Reported Event|Umeclidinium/Vilanterol - Matched Cohort|Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018.
11343859|NCT03980470|BG000|Baseline|Normal-dose Versus Low-dose|"The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL.~The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes."
11343860|NCT03980470|FG000|Participant Flow|Normal-dose Versus Low-dose|"The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL.~The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes."
11343861|NCT03980470|OG000|Outcome|Normal-dose Versus Low-dose|"The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL.~The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes."
11343862|NCT03980470|OG000|Outcome|Low-dose|"The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL.~The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes."
11343863|NCT03980470|OG000|Outcome|Normal-Dose Versus Low-dose|"The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL.~The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes."
11348497|NCT04157738|FG000|Participant Flow|Fixed Group|"Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.~Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)~Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)"
11348498|NCT04157738|FG001|Participant Flow|Insulin to Carbohydrate Ratio (ICR) Group|"Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen~Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)~Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)"
11343864|NCT03980470|EG000|Reported Event|Low-dose|"The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.~TrueFidelity: TrueFidelity (Deep Learning Image Reconstruction, DLIR) software by GE Healthcare.~The medical device in question is a novel reconstruction algorithm for raw CT data which is based on artificial intelligence approaches, namely deep-learning iterative reconstruction (DLIR). This DLIR algorithm will be installed on the console of the CT Revolution scanning device, which is in routine clinical use for cardiac CT scans at the Department of Nuclear Medicine at the University Hospital Zurich. Purpose of this installation is the assessment of the performance of the DLIR algorithm during a limited time span of six weeks.~The algorithm will be CE-marked at the time of installation and use (statement by GE Healthcare provided separately). Its intended use is the reconstruction of CT datasets.~Of note, the novel DLIR algorithm will not substitute any clinical routine procedures currently in use. That is, diagnosis will still be made using the standard reconstruction algorithms."
11343865|NCT03980470|EG001|Reported Event|Normal-dose|The control intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL.
11343866|NCT03982069|BG000|Baseline|FluMist Live Attenuated Influenza Vaccine 2019|"Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally~FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete."
11343867|NCT03982069|BG001|Baseline|Flucelvax Inactivated Influenza Vaccine 2019|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete."
11343868|NCT03982069|BG002|Baseline|FluMist Live Attenuated Influenza Vaccine 2020|"Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally~FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete."
11343869|NCT03982069|BG003|Baseline|Flucelvax Inactivated Influenza Vaccine 2020|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete."
11343870|NCT03982069|BG004|Baseline|Total|Total of all reporting groups
11343871|NCT03982069|FG000|Participant Flow|FluMist Live Attenuated Influenza Vaccine 2019|"Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally~FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete."
11343872|NCT03982069|FG001|Participant Flow|Flucelvax Inactivated Influenza Vaccine 2019|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete."
11343873|NCT03982069|FG002|Participant Flow|FluMist Live Attenuated Influenza Vaccine 2020|"Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally~FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete."
11343874|NCT03982069|FG003|Participant Flow|Flucelvax Inactivated Influenza Vaccine 2020|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete."
11343875|NCT03982069|OG000|Outcome|FluMist Live Attenuated Influenza Vaccine 2019|"Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally~FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete."
11343876|NCT03982069|OG001|Outcome|Flucelvax Inactivated Influenza Vaccine 2019|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete."
11343877|NCT03982069|OG000|Outcome|FluMist Live Attenuated Influenza Vaccine 2020|"Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally~FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete."
11343878|NCT03982069|OG001|Outcome|Flucelvax Inactivated Influenza Vaccine 2020|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete."
11343879|NCT03982069|EG000|Reported Event|FluMist Live Attenuated Influenza Vaccine|"Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally~FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete."
11343880|NCT03982069|EG001|Reported Event|Flucelvax Inactivated Influenza Vaccine|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete."
11343881|NCT03984812|BG000|Baseline|Part 1- Cohort 1: GSK3732394 10 mg|Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.
11343882|NCT03984812|BG001|Baseline|Part 1- Cohort 2: GSK3732394 20 mg|Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.
11343883|NCT03984812|BG002|Baseline|Part 1- Cohort 3: GSK3732394 80 mg|Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.
11343884|NCT03984812|BG003|Baseline|Part 1- Placebo|Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.
11343885|NCT03984812|BG004|Baseline|Part 1- Cohort 4: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394
11343886|NCT03984812|BG005|Baseline|Part 1- Cohort 5: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343887|NCT03984812|BG006|Baseline|Part 1- Cohort 6: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343888|NCT03984812|BG007|Baseline|Part 2- Cohort 1: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343889|NCT03984812|BG008|Baseline|Part 2- Cohort 2: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22
11343890|NCT03984812|BG009|Baseline|Part 2- Cohort 3: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343891|NCT03984812|BG010|Baseline|Part 2: Placebo|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 matching placebo on Days 1, 8, 15 and 22 in cohorts 1, 2 and 3.
11343892|NCT03984812|BG011|Baseline|Total|Total of all reporting groups
11343893|NCT03984812|FG000|Participant Flow|Part 1- Cohort 1: GSK3732394 10 mg|Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.
11343894|NCT03984812|FG001|Participant Flow|Part 1- Cohort 2: GSK3732394 20 mg|Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.
11343895|NCT03984812|FG002|Participant Flow|Part 1- Cohort 3: GSK3732394 80 mg|Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.
11343896|NCT03984812|FG003|Participant Flow|Part 1- Placebo|Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.
11343897|NCT03984812|FG004|Participant Flow|Part 1- Cohort 4: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394
11343898|NCT03984812|FG005|Participant Flow|Part 1- Cohort 5: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343899|NCT03984812|FG006|Participant Flow|Part 1- Cohort 6: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343900|NCT03984812|FG007|Participant Flow|Part 2- Cohort 1: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343901|NCT03984812|FG008|Participant Flow|Part 2- Cohort 2: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22
11343902|NCT03984812|FG009|Participant Flow|Part 2- Cohort 3: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343903|NCT03984812|FG010|Participant Flow|Part 2: Placebo|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 matching placebo on Days 1, 8, 15 and 22 in cohorts 1, 2 and 3.
11343904|NCT03984812|OG000|Outcome|Part 1- Cohort 1: GSK3732394 10 mg|Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.
11343905|NCT03984812|OG001|Outcome|Part 1- Cohort 2: GSK3732394 20 mg|Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.
11343906|NCT03984812|OG002|Outcome|Part 1- Cohort 3: GSK3732394 80 mg|Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.
11343907|NCT03984812|OG003|Outcome|Part 1- Placebo|Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.
11343908|NCT03984812|OG004|Outcome|Part 1- Cohort 4: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394
11343909|NCT03984812|OG005|Outcome|Part 1- Cohort 5: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343910|NCT03984812|OG006|Outcome|Part 1- Cohort 6: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343911|NCT03984812|OG000|Outcome|Part 2- Cohort 1: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343912|NCT03984812|OG001|Outcome|Part 2- Cohort 2: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343913|NCT03984812|OG002|Outcome|Part 2- Cohort 3: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343914|NCT03984812|OG003|Outcome|Part 2: Placebo|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 matching placebo on Days 1, 8, 15 and 22 in cohorts 1, 2 and 3.
11343915|NCT03984812|OG003|Outcome|Part 1- Cohort 4: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394
11343916|NCT03984812|OG004|Outcome|Part 1- Cohort 5: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343917|NCT03984812|OG005|Outcome|Part 1- Cohort 6: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343918|NCT03984812|EG000|Reported Event|Part 1- Cohort 1: GSK3732394 10 mg|Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.
11343919|NCT03984812|EG001|Reported Event|Part 1- Cohort 2: GSK3732394 20 mg|Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.
11343920|NCT03984812|EG002|Reported Event|Part 1- Cohort 3: GSK3732394 80 mg|Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.
10976394|NCT00940316|OG000|Outcome|Arm A: Erlotinib + Panitumumab + Irinotecan|"Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks"
10976395|NCT00940316|OG001|Outcome|Arm B: Erlotinib + Panitumumab|"Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily"
10976396|NCT00940316|OG002|Outcome|Arm C: Erlotinib + Panitumumab|"Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily"
10976397|NCT00940316|OG000|Outcome|Arm A + Arm B + Arm C|"Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks"
10976398|NCT00940316|OG000|Outcome|Arm A: Erlotinib + Panitumumab + Irinotecan|"Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype"
10976399|NCT00940316|OG001|Outcome|Arm B: Erlotinib + Panitumumab|"Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype"
10976400|NCT00940316|OG002|Outcome|Arm C: Erlotinib + Panitumumab|"Patients receive erlotinib hydrochloride and panitumumab as in arm B.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily"
10976401|NCT00940316|OG003|Outcome|Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan|"Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype~After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle."
10976402|NCT00940316|OG000|Outcome|Arm A: Erlotinib + Panitumumab + Irinotecan|"Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks"
10976403|NCT00940316|OG001|Outcome|Arm B: Erlotinib + Panitumumab|"Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily"
10976404|NCT00940316|EG000|Reported Event|Arm A: Erlotinib + Panitumumab + Irinotecan|"Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype"
10976405|NCT00940316|EG001|Reported Event|Arm B: Erlotinib + Panitumumab|"Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype"
10976406|NCT00940316|EG002|Reported Event|Arm C: Erlotinib + Panitumumab|"Patients receive erlotinib hydrochloride and panitumumab as in arm B.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily"
11343921|NCT03984812|EG003|Reported Event|Part 1- Placebo|Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.
11343922|NCT03984812|EG004|Reported Event|Part 1- Cohort 4: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394
11343923|NCT03984812|EG005|Reported Event|Part 1- Cohort 5: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343924|NCT03984812|EG006|Reported Event|Part 1- Cohort 6: GSK3732394|Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
11343925|NCT03984812|EG007|Reported Event|Part 2- Cohort 1: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343926|NCT03984812|EG008|Reported Event|Part 2- Cohort 2: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22
11343927|NCT03984812|EG009|Reported Event|Part 2- Cohort 3: GSK3732394|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.
11343928|NCT03984812|EG010|Reported Event|Part 2: Placebo|Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 matching placebo on Days 1, 8, 15 and 22 in cohorts 1, 2 and 3.
11343929|NCT03985813|BG000|Baseline|Screening Wizard|"Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.~Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment."
11343930|NCT03985813|BG001|Baseline|Treatment As Usual (TAU)|Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
11343931|NCT03985813|BG002|Baseline|Total|Total of all reporting groups
11343932|NCT03985813|FG000|Participant Flow|Screening Wizard|"Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.~Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment."
11343933|NCT03985813|FG001|Participant Flow|Treatment As Usual (TAU)|Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
11343934|NCT03985813|OG000|Outcome|Screening Wizard|"Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.~Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment."
11343935|NCT03985813|OG001|Outcome|Treatment As Usual (TAU)|Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
11343936|NCT03985813|EG000|Reported Event|Screening Wizard|"Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.~Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment."
11343937|NCT03985813|EG001|Reported Event|Treatment As Usual (TAU)|Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
11343938|NCT03998163|BG000|Baseline|CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
11343939|NCT03998163|FG000|Participant Flow|CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
11343940|NCT03998163|OG000|Outcome|CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
10976407|NCT00940316|EG003|Reported Event|Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan|"Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~Upon disease progression, patients receive irinotecan hydrochloride as in arm A.~panitumumab: Given intravenously 6mg/kg every 2 weeks~erlotinib hydrochloride: Given orally 150mg daily~irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype~After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle."
10976408|NCT00940342|BG000|Baseline|Treated and Relapsed - Group 1|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976409|NCT00940342|BG001|Baseline|Untreated and High-Risk for Progression - Group 2|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976410|NCT00940342|BG002|Baseline|70 Years of Age and Refused Chemo - Group 3|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976411|NCT00940342|BG003|Baseline|Total|Total of all reporting groups
10976412|NCT00940342|FG000|Participant Flow|Treated and Relapsed - Group 1|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976413|NCT00940342|FG001|Participant Flow|Untreated and High-Risk for Progression - Group 2|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
11343941|NCT03998163|EG000|Reported Event|CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
11343942|NCT04000373|BG000|Baseline|Gait Training With Exoskeleton Device|"uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton~Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits."
11343943|NCT04000373|FG000|Participant Flow|Gait Training With Exoskeleton Device|"uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton~Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits."
11343944|NCT04000373|OG000|Outcome|Gait Training With Exoskeleton Device|"uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton~Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits."
11343945|NCT04000373|EG000|Reported Event|Gait Training With Exoskeleton Device|"uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton~Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits."
11343946|NCT04001517|BG000|Baseline|Neflamapimod TID|40 mg capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg
11343947|NCT04001517|BG001|Baseline|Neflamapimod BID|40 mg capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg
11343948|NCT04001517|BG002|Baseline|Placebo|Placebo capsules matched to neflamapimod capsules, administered orally BID or TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg or the BID regiment if Screening weight was <80 kg
11343949|NCT04001517|BG003|Baseline|Total|Total of all reporting groups
11343950|NCT04001517|FG000|Participant Flow|Neflamapimod TID|40 mg capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg
11343951|NCT04001517|FG001|Participant Flow|Neflamapimod BID|40 mg capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg
11343952|NCT04001517|FG002|Participant Flow|Placebo TID|40 mg matching placebo capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg
11343953|NCT04001517|FG003|Participant Flow|Placebo BID|40 mg matching placebo capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg
11343954|NCT04001517|OG000|Outcome|Neflamapimod TID|40 mg capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg
11343955|NCT04001517|OG001|Outcome|Neflamapimod BID|40 mg capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg
11343956|NCT04001517|OG002|Outcome|Placebo|40 mg matching placebo capsules administered orally TID or BID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg and the BID regimen if Screening weight was <80 kg
11343957|NCT04001517|OG000|Outcome|Neflamapimod 40 mg BID|40 mg capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg
11343958|NCT04001517|OG001|Outcome|Neflamapimod TID|40 mg capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg
11343959|NCT04001517|OG001|Outcome|Placebo|40 mg matching placebo capsules administered orally TID or BID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg and the BID regimen if Screening weight was <80 kg
11343960|NCT04001517|EG000|Reported Event|Neflamapimod TID|40 mg capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg
11343961|NCT04001517|EG001|Reported Event|Neflamapimod BID|40 mg capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg
11343962|NCT04001517|EG002|Reported Event|Placebo|40 mg matching placebo capsules administered orally TID or BID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg and the BID regimen if Screening weight was <80 kg
11343963|NCT04006171|BG000|Baseline|Women With Polycystic Ovary Syndrome|"36 patients with PCOS~C type natriuretic peptide: Serum level of CNP in PCOS and healthy women"
11343964|NCT04006171|BG001|Baseline|Healthy Women of Reproductive Age|"30 patients with regular normal menstrual cycle~C type natriuretic peptide: Serum level of CNP in PCOS and healthy women"
11343965|NCT04006171|BG002|Baseline|Total|Total of all reporting groups
11343966|NCT04006171|FG000|Participant Flow|Women With Polycystic Ovary Syndrome|"36 patients with PCOS~C type natriuretic peptide: Serum level of CNP in PCOS and healthy women"
11343967|NCT04006171|FG001|Participant Flow|Healthy Women of Reproductive Age|"30 patients with regular normal menstrual cycle~C type natriuretic peptide: Serum level of CNP in PCOS and healthy women"
11343968|NCT04006171|OG000|Outcome|Women With Polycystic Ovary Syndrome|"36 patients with PCOS~C type natriuretic peptide: Serum level of CNP in PCOS and healthy women"
10976414|NCT00940342|FG002|Participant Flow|70 Years of Age and Refused Chemo - Group 3|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
11343969|NCT04006171|OG001|Outcome|Healthy Women of Reproductive Age|"30 patients with regular normal menstrual cycle~C type natriuretic peptide: Serum level of CNP in PCOS and healthy women"
11343970|NCT04006171|OG000|Outcome|All Participants|all participants of the study
11343971|NCT04006171|EG000|Reported Event|Women With Polycystic Ovary Syndrome|"36 patients with PCOS~C type natriuretic peptide: Serum level of CNP in PCOS and healthy women"
11343972|NCT04006171|EG001|Reported Event|Healthy Women of Reproductive Age|"30 patients with regular normal menstrual cycle~C type natriuretic peptide: Serum level of CNP in PCOS and healthy women"
11343973|NCT04011436|BG000|Baseline|Core, Hip and Knee.|"Physical Exercises to strengthen the core, hip and knee.~Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.~Group A: 28 exercises Group B: 24 exercises"
11343974|NCT04011436|BG001|Baseline|Hip and Knee|"Physical Exercises to strengthen the hip and knee.~Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.~Group A: 28 exercises Group B: 24 exercises"
11343975|NCT04011436|BG002|Baseline|Total|Total of all reporting groups
11343976|NCT04011436|FG000|Participant Flow|Core, Hip and Knee.|"Physical Exercises to strengthen the core, hip and knee.~Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.~Group A: 28 exercises Group B: 24 exercises"
11343977|NCT04011436|FG001|Participant Flow|Hip and Knee|"Physical Exercises to strengthen the hip and knee.~Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.~Group A: 28 exercises Group B: 24 exercises"
11343978|NCT04011436|OG000|Outcome|Core, Hip and Knee.|"Physical Exercises to strengthen the core, hip and knee.~Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.~Group A: 28 exercises Group B: 24 exercises"
11343979|NCT04011436|OG001|Outcome|Hip and Knee|"Physical Exercises to strengthen the hip and knee.~Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.~Group A: 28 exercises Group B: 24 exercises"
10976415|NCT00940342|OG000|Outcome|Treated and Relapsed - Group 1|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976416|NCT00940342|OG001|Outcome|Untreated and High-Risk for Progression - Group 2|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976417|NCT00940342|OG002|Outcome|70 Years of Age and Refused Chemo - Group 3|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976418|NCT00940342|EG000|Reported Event|Treated and Relapsed - Group 1|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976419|NCT00940342|EG001|Reported Event|Untreated and High-Risk for Progression - Group 2|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976420|NCT00940342|EG002|Reported Event|70 Years of Age and Refused Chemo - Group 3|"Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.~GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.~Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks"
10976421|NCT00940446|BG000|Baseline|Insorb Staples|Subcuticular Absorbable staples
10976422|NCT00940446|BG001|Baseline|Control|Metal staple wound closure
10976423|NCT00940446|BG002|Baseline|Total|Total of all reporting groups
10976424|NCT00940446|FG000|Participant Flow|Insorb Staples|"Subcuticular Absorbable staples~Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples."
10976425|NCT00940446|FG001|Participant Flow|Control|"Metal staple wound closure~Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure."
10976426|NCT00940446|OG000|Outcome|Insorb Staples|"Subcuticular Absorbable staples~Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples."
10976427|NCT00940446|OG001|Outcome|Control-metal Staples|"Metal staple wound closure~Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure."
10976428|NCT00940446|OG000|Outcome|Insorb Staples|"Subcuticular Absorbable staples~30 enrollees~Avg age~Avg BMI~Sex~Avg # staples placed~Avg incision length"
10976429|NCT00940446|OG001|Outcome|Control|"Metal staple wound closure~30 enrollees~Avg age~Avg BMI~Sex~Avg # staples placed~Avg incision length"
10976430|NCT00940446|EG000|Reported Event|Insorb Staples|"Subcuticular Absorbable staples~Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples."
10976431|NCT00940446|EG001|Reported Event|Control|"Metal staple wound closure~Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure."
10976432|NCT00940485|BG000|Baseline|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
10976433|NCT00940485|BG001|Baseline|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
10976434|NCT00940485|BG002|Baseline|Total|Total of all reporting groups
10855151|NCT00326963|OG000|Outcome|Enfuride+PI+ARV's|"Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½ needle/syringe, 31G 8 mm needle/syringe or B2000 NFID."
10976435|NCT00940485|FG000|Participant Flow|Peginterferon Alfa-2a + Entecavir|Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
10976436|NCT00940485|FG001|Participant Flow|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
10976437|NCT00940485|OG000|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
11222860|NCT02349542|OG000|Outcome|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
10855152|NCT00326963|EG000|Reported Event|Enfuvirtide+PI+ARV's|"Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½ needle/syringe, 31G 8 mm needle/syringe or B2000 NFID."
10855153|NCT00327015|BG000|Baseline|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
10855154|NCT00327015|BG001|Baseline|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
10855155|NCT00327015|BG002|Baseline|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
10855156|NCT00327015|BG003|Baseline|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
10855157|NCT00327015|BG004|Baseline|Total|Total of all reporting groups
10855158|NCT00327015|FG000|Participant Flow|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
10855159|NCT00327015|FG001|Participant Flow|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
10855160|NCT00327015|FG002|Participant Flow|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
10976438|NCT00940485|OG001|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
10976439|NCT00940485|EG000|Reported Event|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
10976440|NCT00940485|EG001|Reported Event|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
10976441|NCT00940537|BG000|Baseline|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
10976442|NCT00940537|BG001|Baseline|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
10976443|NCT00940537|BG002|Baseline|Total|Total of all reporting groups
10976444|NCT00940537|FG000|Participant Flow|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
10976445|NCT00940537|FG001|Participant Flow|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
10976446|NCT00940537|OG000|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
10976447|NCT00940537|OG001|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
10976448|NCT00940537|OG000|Outcome|All Subjects|all subjects studied. This includes both lean and obese subjects with a range of intrahepatic triglyceride.
10976449|NCT00940537|EG000|Reported Event|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
11343980|NCT04011436|EG000|Reported Event|Core, Hip and Knee.|"Physical Exercises to strengthen the core, hip and knee.~Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.~Group A: 28 exercises Group B: 24 exercises"
11343981|NCT04011436|EG001|Reported Event|Hip and Knee|"Physical Exercises to strengthen the hip and knee.~Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.~Group A: 28 exercises Group B: 24 exercises"
11343982|NCT04011592|BG000|Baseline|Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg|"single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)~Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)~Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)"
11343983|NCT04011592|BG001|Baseline|Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg|"single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)~Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)~Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)"
11343984|NCT04011592|BG002|Baseline|Total|Total of all reporting groups
11343985|NCT04011592|FG000|Participant Flow|Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg|"single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)~Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)~Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)"
11343986|NCT04011592|FG001|Participant Flow|Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg|"single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)~Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)~Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)"
11343987|NCT04011592|OG000|Outcome|Ketamine 0.5 mg/kg|Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)
11343988|NCT04011592|OG001|Outcome|Ketamine 0.2 mg/kg|Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)
11343989|NCT04011592|EG000|Reported Event|Ketamine 0.5 mg/kg|Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)
11343990|NCT04011592|EG001|Reported Event|Ketamine 0.2 mg/kg|Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)
10976450|NCT00940537|EG001|Reported Event|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
11343991|NCT04013529|BG000|Baseline|Control|"Participate in technology-enabled care without regret lottery~Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals."
11343992|NCT04013529|BG001|Baseline|Experimental|"Participate in technology-enabled care with regret lottery~Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.~Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals."
11343993|NCT04013529|BG002|Baseline|Total|Total of all reporting groups
11343994|NCT04013529|FG000|Participant Flow|Control|"Participate in technology-enabled care without regret lottery~Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals."
11343995|NCT04013529|FG001|Participant Flow|Experimental|"Participate in technology-enabled care with regret lottery~Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.~Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals."
11343996|NCT04013529|OG000|Outcome|Control|"Participate in technology-enabled care without regret lottery~Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals."
11343997|NCT04013529|OG001|Outcome|Experimental|"Participate in technology-enabled care with regret lottery~Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.~Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals."
11343998|NCT04013529|EG000|Reported Event|Control|"Participate in technology-enabled care without regret lottery~Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals."
11343999|NCT04013529|EG001|Reported Event|Experimental|"Participate in technology-enabled care with regret lottery~Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.~Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals."
11344000|NCT04016324|BG000|Baseline|Baseline|Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit
11344001|NCT04016324|FG000|Participant Flow|Basic Evaluation Subjects|Out of 134 overactive bladder consented subjects in the study, 110 underwent basic evaluation with the commercially approved foramen needle and basic evaluation kit, and 107 subjects completed the study.
10976451|NCT00940576|BG000|Baseline|All Study Participants|Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively.
11344002|NCT04016324|OG000|Outcome|Motor or Sensory Response of Lead|Response to Lead
11344003|NCT04016324|OG001|Outcome|Motor or Sensory Response of Needle|Response to Needle
11344004|NCT04016324|EG000|Reported Event|Basic Evaluation Subjects|For the mortality and serious adverse events, all consented subjects (134) were included. Since non-serious events can only be device, therapy or stimulation related, only subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) were included.
11344005|NCT04017910|BG000|Baseline|EchoMark/EchoSure Stage 1|EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
11344006|NCT04017910|FG000|Participant Flow|EchoMark/EchoSure Stage 1|EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
11344007|NCT04017910|OG000|Outcome|EchoMark/EchoSure Stage 1|EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
11344008|NCT04017910|EG000|Reported Event|EchoMark/EchoSure Stage 1|EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
11344009|NCT04018066|BG000|Baseline|GP-SPI Intervention|"Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.~GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)"
11344010|NCT04018066|FG000|Participant Flow|GP-SPI Intervention|"Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.~GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)"
11344011|NCT04018066|OG000|Outcome|GP-SPI Intervention|"Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.~GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)"
11344012|NCT04018066|OG000|Outcome|GP-SPI Intervention|"20 g of GP-SPI taken twice per day for 10 days~GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)"
11344013|NCT04018066|EG000|Reported Event|GP-SPI Intervention|"Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.~GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)"
11344014|NCT04018794|BG000|Baseline|Behavioral/Organizational Skills Intervention Plus Mobile App|"Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)~Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation"
11344015|NCT04018794|FG000|Participant Flow|Behavioral/Organizational Skills Intervention Plus Mobile App|"Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)~Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation"
10855161|NCT00327015|FG003|Participant Flow|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
11344016|NCT04018794|OG000|Outcome|Behavioral/Organizational Skills Intervention Plus Mobile App|"Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)~Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation"
11344017|NCT04018794|EG000|Reported Event|Behavioral/Organizational Skills Intervention Plus Mobile App|"Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)~Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation"
11344018|NCT04032327|BG000|Baseline|Plain Bupivacaine|"20 mL of 0.25% plain bupivacaine~Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy"
11344019|NCT04032327|BG001|Baseline|Exparel Plus Plain Bupivacaine|"10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed~Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy"
11344020|NCT04032327|BG002|Baseline|Total|Total of all reporting groups
11344021|NCT04032327|FG000|Participant Flow|Plain Bupivacaine|"20 mL of 0.25% plain bupivacaine~Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy"
11344022|NCT04032327|FG001|Participant Flow|Exparel Plus Plain Bupivacaine|"10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed~Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy"
11344023|NCT04032327|OG000|Outcome|Plain Bupivacaine|"20 mL of 0.25% plain bupivacaine~Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy"
11344024|NCT04032327|OG001|Outcome|Exparel Plus Plain Bupivacaine|"10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed~Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy"
11344025|NCT04032327|EG000|Reported Event|Plain Bupivacaine|"20 mL of 0.25% plain bupivacaine~Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy"
11344026|NCT04032327|EG001|Reported Event|Exparel Plus Plain Bupivacaine|"10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed~Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy"
10855162|NCT00327015|OG000|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
10855163|NCT00327015|OG001|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
11344027|NCT04033640|BG000|Baseline|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site, study staff performed SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples.~At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by CBC."
11344028|NCT04033640|BG001|Baseline|Health Workers|Participants were trained on use of the STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation.
11344029|NCT04033640|BG002|Baseline|Total|Total of all reporting groups
11344030|NCT04033640|FG000|Participant Flow|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site, study staff performed the Standard Diagnostics (SD) Biosensor STANDARD glucose-6-phosphate dehydrogenase (G6PD) test and the POC HemoCue hemoglobin test on finger stick blood samples.~At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by a complete blood count (CBC) using an automated hematology analyzer (Manaus site only)."
11344031|NCT04033640|FG001|Participant Flow|Health Workers|Participants were trained on use of the STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation.
11344032|NCT04033640|OG000|Outcome|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site, study staff performed SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples.~At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by CBC."
11344033|NCT04033640|OG000|Outcome|Health Workers|Participants were trained on use of the STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation.
11344034|NCT04033640|EG000|Reported Event|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site, study staff performed SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples.~At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by CBC."
11344035|NCT04033640|EG001|Reported Event|Health Workers|Participants were trained on use of the STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation.
11344036|NCT04036292|BG000|Baseline|OC-01 Low Dose 0.6 mg/mL BID for 28 Days|"OC-01 (varenicline) nasal spray, 0.6 mg/ML BID for 28 days~OC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray"
11344037|NCT04036292|BG001|Baseline|OC-01 High Dose 1.2 mg/mL BID for 28 Days|"OC-01 (varenicline) nasal spray, 1.2 mg/ML BID for 28 days~OC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray"
11344038|NCT04036292|BG002|Baseline|Placebo (Vehicle) Nasal Spray BID for 28 Days|"Placebo (vehicle) nasal spray BID for 28 days~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11344039|NCT04036292|BG003|Baseline|Total|Total of all reporting groups
11344040|NCT04036292|FG000|Participant Flow|OC-01 Low Dose 0.6 mg/mL BID for 28 Days|OC-01 (varenicline) nasal spray, 0.6 mg/ML BID for 28 days
11344041|NCT04036292|FG001|Participant Flow|OC-01 High Dose 1.2 mg/mL BID for 28 Days|OC-01 (varenicline) nasal spray 1.2 mg/mL BID for 28 days
11344042|NCT04036292|FG002|Participant Flow|Placebo BID for 28 Days|Placebo (vehicle) nasal spray BID for 28 days
11344043|NCT04036292|OG000|Outcome|OC-01 Low Dose, 0.6 mg/mL|"OC-01 (varenicline) nasal spray, 0.6 mg/ML~OC-01 (varenicline) nasal spray"
11344044|NCT04036292|OG001|Outcome|OC-01 High Dose, 1.2 mg/mL|"OC-01 (varenicline) nasal spray, 1.2 mg/ML~OC-01 (varenicline) nasal spray"
10976452|NCT00940576|FG000|Participant Flow|Oral Intake of Mare´s Milk First, Then Placebo|Oral Intake of 250 ml per day Mare´s Milk First, Then 250 ml per day Placebo
11344045|NCT04036292|OG002|Outcome|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray"
11344046|NCT04036292|OG000|Outcome|OC-01 Low Dose, 0.6 mg/mL|OC-01 (varenicline) nasal spray, 0.6 mg/ML
11344047|NCT04036292|OG001|Outcome|OC-01 High Dose, 1.2 mg/mL|OC-01 (varenicline) nasal spray, 1.2 mg/ML
11344048|NCT04036292|OG002|Outcome|Placebo|Placebo (vehicle) nasal spray
11344049|NCT04036292|EG000|Reported Event|OC-01 Low Dose, 0.6 mg/mL|OC-01 (varenicline) nasal spray, 0.6 mg/ML
11344050|NCT04036292|EG001|Reported Event|OC-01 High Dose, 1.2 mg/mL|OC-01 (varenicline) nasal spray, 1.2 mg/ML
11344051|NCT04036292|EG002|Reported Event|Placebo|Placebo (vehicle) nasal spray
11344052|NCT04041440|BG000|Baseline|Auditory Training|"Pre- and post assessments of auditory training intervention~clEAR auditory training: Children play auditory brain training computer gamesFocus"
11344053|NCT04041440|BG001|Baseline|Focus Group|"Two focus groups~Focus groups to collect feedback on current version of games"
11344054|NCT04041440|BG002|Baseline|Total|Total of all reporting groups
11344055|NCT04041440|FG000|Participant Flow|Focus Groups|Two groups of children participated in focus groups (N=7 and N=5). Results of subjective questions and focused conversations from the focus groups were used to update and modify the clEAR games to make them more fun and engaging.
11344056|NCT04041440|FG001|Participant Flow|Auditory Training Group|One group of children participated in auditory training (N=20 completed the protocol, 22 were consented). Results of objective pre- and post-training assessments from the training group were compared to evaluate the effectiveness of the games.
11344057|NCT04041440|OG000|Outcome|Auditory Training Group|Children playing auditory brain training computer games
11344058|NCT04041440|OG000|Outcome|Auditory Training Group|Children with hearing impairment playing auditory brain training computer games
11344059|NCT04041440|OG000|Outcome|Auditory Training Group|Children that played the auditory brain training computer games
11344060|NCT04041440|EG000|Reported Event|Focus Groups|Two groups of children participated in focus groups (N=7 and N=5). Results of subjective questions and focused conversations from the focus groups were used to update and modify the clEAR games to make them more fun and engaging.
11344061|NCT04041440|EG001|Reported Event|Auditory Training Group|One group of children participated in auditory training (N=20 completed the protocol, 22 were consented). Results of objective pre- and post-training assessments from the training group were compared to evaluate the effectiveness of the games.
11344062|NCT04041570|BG000|Baseline|Group 1: cAd3-EBO S Vaccine (1x10^10 PU)|"cAd3-EBO S vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL~cAd3-EBO S vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP)."
11344063|NCT04041570|BG001|Baseline|Group 2: cAd3-EBO S Vaccine (1x10^11 PU)|"cAd3-EBO S vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL~cAd3-EBO S vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP)."
11344064|NCT04041570|BG002|Baseline|Total|Total of all reporting groups
11344065|NCT04041570|FG000|Participant Flow|Group 1: cAd3-EBO S Vaccine (1x10^10 PU)|"cAd3-EBO S vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL~cAd3-EBO S vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP)."
11344066|NCT04041570|FG001|Participant Flow|Group 2: cAd3-EBO S Vaccine (1x10^11 PU)|"cAd3-EBO S vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL~cAd3-EBO S vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP)."
11344067|NCT04041570|OG000|Outcome|Group 1: cAd3-EBO S Vaccine (1x10^10 PU)|"cAd3-EBO S vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL~cAd3-EBO S vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP)."
11344068|NCT04041570|OG001|Outcome|Group 2: cAd3-EBO S Vaccine (1x10^11 PU)|"cAd3-EBO S vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL~cAd3-EBO S vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP)."
11344069|NCT04041570|OG002|Outcome|Overall Incidence cAd3-EBO S Vaccine (1x10^10 PU and 1x10^11 PU)|Dose groups included adults who received a single dose of cAd3-EBO S vaccine at either 1x10^10 PU or 1x10^11 PU
11344070|NCT04041570|EG000|Reported Event|Group 1: cAd3-EBO S Vaccine (1x10^10 PU)|"cAd3-EBO S vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL~cAd3-EBO S vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP)."
11344071|NCT04041570|EG001|Reported Event|Group 2: cAd3-EBO S Vaccine (1x10^11 PU)|"cAd3-EBO S vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL~cAd3-EBO S vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP)."
11344072|NCT04043143|BG000|Baseline|Arm 1 Prescription As Usual|"At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.~Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge."
11344073|NCT04043143|BG001|Baseline|Arm 2 Prescription Tool Intervention|"At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked.~Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated."
11344074|NCT04043143|BG002|Baseline|Total|Total of all reporting groups
11344075|NCT04043143|FG000|Participant Flow|Arm 1 Prescription As Usual|"At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.~Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge."
11348499|NCT04157738|OG000|Outcome|Fixed Group|"Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.~Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)~Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)"
10976453|NCT00940576|FG001|Participant Flow|Oral Intake of Placebo First, Then Mare´s Milk|Oral intake of 250 ml per day placebo first, then 250 ml per day mare´s milk
10976454|NCT00940576|OG000|Outcome|Entire Study Population|oral intake of 250 ml mare´s milk or placebo drink daily
10976455|NCT00940576|OG000|Outcome|Patients Crohn´s Disease|
10976456|NCT00940576|OG001|Outcome|Patients Ulcerative Colitis|
11344076|NCT04043143|FG001|Participant Flow|Arm 2 Prescription Tool Intervention|"At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked.~Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated."
11344077|NCT04043143|OG000|Outcome|Arm 1 Prescription As Usual|"At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.~Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge."
11344078|NCT04043143|OG001|Outcome|Arm 2 Prescription Tool Intervention|"At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked.~Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated."
11344079|NCT04043143|EG000|Reported Event|Arm 1 Prescription As Usual|"At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.~Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge."
11344080|NCT04043143|EG001|Reported Event|Arm 2 Prescription Tool Intervention|"At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked.~Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated."
11344081|NCT04049123|BG000|Baseline|Overall Baseline|Participants received a single 7 U, and a single 15 U SC dose of LY900014 in 2 of 3 periods and 15 U SC dose of Humalog in 1 of 3 periods.
11344082|NCT04049123|FG000|Participant Flow|Sequence 1: CAB|"Participants received a single SC dose in each treatment period.~C = 15 U Humalog~A = 7 U LY900014~B = 15 U LY900014"
11344083|NCT04049123|FG001|Participant Flow|Sequence 2: ACB|"Participants received a single SC dose in each treatment period.~A = 7 U LY900014~C = 15 U Humalog~B = 15 U LY900014"
11344084|NCT04049123|FG002|Participant Flow|Sequence 3: ABC|"Participants received a single SC dose in each treatment period.~A = 7 U LY900014~B = 15 U LY900014~C = 15 U Humalog"
11344085|NCT04049123|OG000|Outcome|7 U LY900014|Single SC dose 7 U LY900014.
11344086|NCT04049123|OG001|Outcome|15 U LY900014|Single SC dose 15 U LY900014.
11344087|NCT04049123|OG002|Outcome|15 U Humalog|Single SC dose 15 U Humalog.
11344088|NCT04049123|EG000|Reported Event|7 Unit (U) LY900014|Single subcutaneous (SC) dose 7 U LY900014.
11344089|NCT04049123|EG001|Reported Event|15 U LY900014|Single SC dose 15 U LY900014.
10976457|NCT00940576|EG000|Reported Event|Group 1|oral intake of 250 ml mare's milk daily
11344090|NCT04049123|EG002|Reported Event|15 U Humalog|Single SC dose 15 U Humalog.
11344091|NCT04051463|BG000|Baseline|Netarsudil|"A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.~Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily"
11344092|NCT04051463|BG001|Baseline|Placebo|"A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.~Placebo: Placebo eye drops instilled once daily"
11344093|NCT04051463|BG002|Baseline|Total|Total of all reporting groups
11344094|NCT04051463|FG000|Participant Flow|Netarsudil|"A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.~Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily"
11344095|NCT04051463|FG001|Participant Flow|Placebo|"A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.~Placebo: Placebo eye drops instilled once daily"
11344096|NCT04051463|OG000|Outcome|Netarsudil|"A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.~Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily"
11344097|NCT04051463|OG001|Outcome|Placebo|"A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.~Placebo: Placebo eye drops instilled once daily"
10976458|NCT00940576|EG001|Reported Event|Group 2|oral intake of 250 ml placebo daily
11344098|NCT04051463|EG000|Reported Event|Netarsudil|"A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.~Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily"
11344099|NCT04051463|EG001|Reported Event|Placebo|"A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.~Placebo: Placebo eye drops instilled once daily"
11344100|NCT04052204|BG000|Baseline|Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)|NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
11344101|NCT04052204|FG000|Participant Flow|Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)|NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
11344102|NCT04052204|FG001|Participant Flow|Avelumab + NKTR-214+ Talazoparib (Combination B)|"The dose level for avelumab was fixed at 800 mg Q2W. The starting dose level for NKTR-214 and talazoparib was determined at the completion of the dose finding for Combination A based on available clinical data. The lowest allowed dose for NKTR-214 was 0.003 mg/kg and the lowest allowed dose for talazoparib was 0.5 mg once daily, in which case participants with moderate renal impairment cannot be enrolled. NKTR-214 was administered prior to avelumab. Talazoparib was taken at the clinic after all procedures/assessments completed, before or after the NKTR-214 and avelumab infusions.~Arm was not tested as company terminated this study on 21 May 2021."
11344103|NCT04052204|FG002|Participant Flow|Avelumab + NKTR- 214 + Enzalutamide (Combination C)|"The dose level for avelumab was fixed at 800 mg Q2W. The starting dose level for NKTR-214 and enzalutamide was determined at the completion of the dose finding for Combination A based on available clinical data. The approved label dose for enzalutamide was 160 mg once daily (QD) unless unexpected safety issues requiring it lowering according to the Bayesian Logistic Regression Model (BLRM) recommendation. NKTR-214 was administered prior to avelumab. The daily dose of enzalutamide was taken at the clinic after all procedures/assessments completed, and before or after the avelumab and NKTR-214 infusions.~Arm was not tested as company terminated this study on 21 May 2021."
11344104|NCT04052204|OG000|Outcome|Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)|NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
11344105|NCT04052204|EG000|Reported Event|Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)|NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
11344106|NCT04054661|BG000|Baseline|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger stick capillary blood samples.~At the clinic site lab, study staff conducted the SD Biosensor STANDARD G6PD test and the HemoCue Hb test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
11344107|NCT04054661|FG000|Participant Flow|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger stick capillary blood samples.~At the clinic site lab, study staff conducted the SD Biosensor STANDARD™ point-of-care (POC) G6PD test and the POC HemoCue hemoglobin (Hb) test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
11344108|NCT04054661|OG000|Outcome|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger stick capillary blood samples.~At the clinic site lab, study staff conducted the SD Biosensor STANDARD G6PD test and the HemoCue Hb test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
11344109|NCT04054661|OG000|Outcome|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as fingerstick capillary blood samples.~At the clinic site lab, study staff conducted the SD Biosensor point-of-care G6PD test and the point-of-care HemoCue Hb test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
11344110|NCT04054661|OG000|Outcome|G6PD Diagnostic Testing|Participants in the repeatability substudy provided 8 finger stick capillary blood samples which were tested for G6PD activity using the SD Biosensor STANDARD G6PD test.
11344111|NCT04054661|OG000|Outcome|G6PD Diagnostic Testing|Participants in the repeatability substudy provided 8 finger stick capillary blood samples which were tested for hemoglobin levels using the SD Biosensor STANDARD test.
11344112|NCT04054661|OG000|Outcome|EDTA-anti-coagulated Blood|EDTA-anti-coagulated whole blood samples stored at room temperature.
11344113|NCT04054661|OG001|Outcome|Heparin-anti-coagulated Blood|Heparin-anti-coagulated whole blood samples stored at room temperature.
11344114|NCT04054661|OG002|Outcome|ACD-anti-coagulated Blood|ACD-anti-coagulated whole blood samples stored at room temperature.
11344115|NCT04054661|OG000|Outcome|EDTA-anti-coagulated Blood|EDTA-anti-coagulated whole blood samples stored in a refrigerator.
10848834|NCT00291668|EG001|Reported Event|Certolizumab Pegol 200 mg|Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
10976459|NCT00940589|BG000|Baseline|Circadin|"Drug~Circadin: Prolonged Release melatonin (Circadin) 2mg tablets"
10976460|NCT00940589|BG001|Baseline|Placebo|"drug~Placebo: Matched placebo tablets, with identical features to the Circadin tablets"
10976461|NCT00940589|BG002|Baseline|Total|Total of all reporting groups
10976462|NCT00940589|FG000|Participant Flow|Circadin|"Drug~Circadin: Prolonged Release melatonin (Circadin) 2mg tablets"
10976463|NCT00940589|FG001|Participant Flow|Placebo|"drug~Placebo: Matched placebo tablets, with identical features to the Circadin tablets"
10976464|NCT00940589|OG000|Outcome|Circadin|"Drug~Circadin: Prolonged Release melatonin (Circadin) 2mg tablets"
10976465|NCT00940589|OG001|Outcome|Placebo|"drug~Placebo: Matched placebo tablets, with identical features to the Circadin tablets"
10976466|NCT00940589|EG000|Reported Event|Circadin|"Drug~Circadin: Prolonged Release melatonin (Circadin) 2mg tablets"
10976467|NCT00940589|EG001|Reported Event|Placebo|"drug~Placebo: Matched placebo tablets, with identical features to the Circadin tablets"
10976468|NCT00940602|BG000|Baseline|Deferasirox|10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range
10976469|NCT00940602|BG001|Baseline|Placebo|10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range
10976470|NCT00940602|BG002|Baseline|Total|Total of all reporting groups
10976471|NCT00940602|FG000|Participant Flow|Deferasirox|10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range
10976472|NCT00940602|FG001|Participant Flow|Placebo|10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range
10976473|NCT00940602|OG000|Outcome|Deferasirox|10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range
10976474|NCT00940602|OG001|Outcome|Placebo|10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range
10976475|NCT00940602|EG000|Reported Event|Deferasirox|10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range
11344116|NCT04054661|OG001|Outcome|Heparin-anti-coagulated Blood|Heparin-anti-coagulated whole blood samples stored in a refrigerator.
10976476|NCT00940602|EG001|Reported Event|Placebo|10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range
10976477|NCT00940602|EG002|Reported Event|All Patients|Combined patients from the Deferasirox and Placebo arms
10976478|NCT00940771|BG000|Baseline|Boosted Atazanavir|"Boosted atazanavir was switched for the PI or NNRTI in the patients regimen~Boosted Atazanavir: Boosted atazanavir, once a day dose adjusted for child's weight for 6 months."
10976479|NCT00940771|FG000|Participant Flow|Boosted Atazanavir|"Boosted atazanavir was switched for the PI or NNRTI in the patients regimen~Boosted atazanavir, once a day dose adjusted for child's weight for 6 months."
10976480|NCT00940771|OG000|Outcome|Boosted Atazanavir|"Boosted atazanavir was switched for the PI or NNRTI in the patients regimen~Boosted atazanavir, once a day dose adjusted for child's weight for 6 months."
10976481|NCT00940771|EG000|Reported Event|Boosted Atazanavir|"Boosted atazanavir was switched for the PI or NNRTI in the patients regimen~Boosted atazanavir, once a day dose adjusted for child's weight for 6 months."
11007021|NCT01089062|FG005|Participant Flow|Treatment C, Then B, Then A|"The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
11344117|NCT04054661|OG002|Outcome|ACD-anti-coagulated Blood|ACD-anti-coagulated whole blood samples stored in a refrigerator.
11344118|NCT04054661|EG000|Reported Event|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site lab, study staff conducted the SD Biosensor point-of-care G6PD test and the point-of-care HemoCue Hb test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
11344119|NCT04067011|BG000|Baseline|Group 1:Ciprofloxacin + AV7909|"Group 1 concomitantly received ciprofloxacin and AV7909.~Ciprofloxacin 500mg Tablet: Ciprofloxacin 500mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.~AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344120|NCT04067011|BG001|Baseline|Group 2: Doxycycline +AV7909|"Group 2 concomitantly received doxycycline and AV7909.~Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.~AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344121|NCT04067011|BG002|Baseline|Group 3: AV7909|AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
11344122|NCT04067011|BG003|Baseline|Total|Total of all reporting groups
11344123|NCT04067011|FG000|Participant Flow|Group 1:Ciprofloxacin + AV7909|"Group 1 concomitantly received ciprofloxacin and AV7909.~Ciprofloxacin 500Mg Tablet: Ciprofloxacin 500mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.~AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344124|NCT04067011|FG001|Participant Flow|Group 2: Doxycycline +AV7909|"Group 2 concomitantly received doxycycline and AV7909.~Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.~AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344125|NCT04067011|FG002|Participant Flow|Group 3: AV7909|AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
11344126|NCT04067011|OG000|Outcome|Ciprofloxacin + AV7909|"Participants meeting entry criteria were randomized 1:1:1 to one of three investigational study groups. Groups 1 to 3 each received a manufactured lot of AV7909 per the study visit schedule.~Group 1 concomitantly received ciprofloxacin.~Ciprofloxacin 500Mg Tablet: Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37."
11344127|NCT04067011|OG000|Outcome|Doxycycline + AV7909|"Group 2 concomitantly received doxycycline. Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.~AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344128|NCT04067011|OG000|Outcome|Group 1:Ciprofloxacin + AV7909|"Group 1 concomitantly received ciprofloxacin. Ciprofloxacin 500Mg Tablet: Ciprofloxacin 500mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.~AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344129|NCT04067011|OG001|Outcome|Group 2: Doxycycline +AV7909|"Group 2 concomitantly received doxycycline. Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.~AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344130|NCT04067011|OG002|Outcome|Group 3: AV7909|AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
11344131|NCT04067011|EG000|Reported Event|Group 1: Ciprofloxacin + AV7909|"Group 1 concomitantly received ciprofloxacin and AV7909.~Ciprofloxacin 500 mg Tablet: Ciprofloxacin 500 mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.~AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344132|NCT04067011|EG001|Reported Event|Group 2: Doxycycline +AV7909|"Group 2 concomitantly received doxycycline and AV7909.~Doxycycline 100 mg Tablet: Doxycycline 100 mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.~AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23."
11344133|NCT04067011|EG002|Reported Event|Group 3: AV7909|AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
11344134|NCT04072159|BG000|Baseline|Pharmacist-Administered HPV Vaccine Series Completion Group|For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
11344135|NCT04072159|BG001|Baseline|Primary Care Provider HPV Vaccine Series Completion|Primary Care Provider HPV Vaccine Series Completion group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
11344136|NCT04072159|BG002|Baseline|Total|Total of all reporting groups
10848835|NCT00291668|EG002|Reported Event|Certolizumab Pegol 400 mg|Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
11344137|NCT04072159|FG000|Participant Flow|Pharmacist-Administered Human Papillomavirus (HPV) Vaccine Series Completion Group|For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
11344138|NCT04072159|FG001|Participant Flow|Primary Care Provider HPV Vaccine Series Completion|Primary Care Provider HPV Vaccine Series Completion Group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
11344139|NCT04072159|OG000|Outcome|Pharmacist-Administered HPV Vaccine Series Completion Group|For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
11344140|NCT04072159|OG001|Outcome|Primary Care Provider HPV Vaccine Series Completion|Primary Care Provider HPV Vaccine Series Completion group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
11344141|NCT04072159|OG000|Outcome|Pharmacist-Administered HPV Vaccine Series Completion Group|Similar to past HPV vaccine pilot interventions with community pharmacists, our study did not enroll and have a retention rate of sufficient participants to demonstrate feasibility.
11344142|NCT04072159|OG000|Outcome|Pharmacist-Administered HPV Vaccine Series Completion Group|Through our semi-structured interview data, we did find that pharmacist-delivered HPV vaccination was acceptable, due, primarily, to convenience.
11344143|NCT04072159|EG000|Reported Event|Pharmacist-Administered HPV Vaccine Series Completion Group|For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
11344144|NCT04072159|EG001|Reported Event|Primary Care Provider HPV Vaccine Series Completion|Primary Care Provider HPV Vaccine Series Completion group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
11344145|NCT04085341|BG000|Baseline|GB-102 Dose 1 (1 mg)|"Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.~GB-102: Intravitreal injection of GB-102"
11344146|NCT04085341|BG001|Baseline|GB-102 Dose 2 (2 mg)|"Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.~GB-102: Intravitreal injection of GB-102"
10855164|NCT00327015|OG002|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
10855165|NCT00327015|OG002|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
11344147|NCT04085341|BG002|Baseline|Total|Total of all reporting groups
11344148|NCT04085341|FG000|Participant Flow|GB-102 Dose 1 (1 mg)|"Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.~GB-102: Intravitreal injection of GB-102"
11344149|NCT04085341|FG001|Participant Flow|GB-102 Dose 2 (2 mg)|"Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.~GB-102: Intravitreal injection of GB-102"
11344150|NCT04085341|OG000|Outcome|GB-102 Dose 1 (1 mg)|"Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.~GB-102: Intravitreal injection of GB-102"
11344151|NCT04085341|OG001|Outcome|GB-102 Dose 2 (2 mg)|"Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.~GB-102: Intravitreal injection of GB-102"
11344152|NCT04085341|EG000|Reported Event|GB-102 Dose 1 (1 mg)|"Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.~GB-102: Intravitreal injection of GB-102"
11344153|NCT04085341|EG001|Reported Event|GB-102 Dose 2 (2 mg)|"Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.~GB-102: Intravitreal injection of GB-102"
11344154|NCT04094870|BG000|Baseline|Antidepressant Medication|"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table~Sertraline: daily SSRI (Sertraline 25mg)"
11344155|NCT04094870|BG001|Baseline|Interpersonal Therapy|"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization~Interpersonal therapy: 11 sessions over a 24-week period"
11344156|NCT04094870|BG002|Baseline|Total|Total of all reporting groups
10855166|NCT00327015|EG000|Reported Event|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
10855167|NCT00327015|EG001|Reported Event|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
10976482|NCT00940823|BG000|Baseline|Ahmed Group|Patients received an Ahmed-FP7 valve implant at the time of surgery.
10855168|NCT00327015|EG002|Reported Event|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
10855169|NCT00327015|EG003|Reported Event|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
10855170|NCT00327171|BG000|Baseline|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
10855171|NCT00327171|BG001|Baseline|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
10855172|NCT00327171|BG002|Baseline|Total|Total of all reporting groups
10855173|NCT00327171|FG000|Participant Flow|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
10855174|NCT00327171|FG001|Participant Flow|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
10855175|NCT00327171|OG000|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
10855176|NCT00327171|OG001|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
10855177|NCT00327171|EG000|Reported Event|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
10855178|NCT00327171|EG001|Reported Event|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
10855179|NCT00327340|BG000|Baseline|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
10855180|NCT00327340|BG001|Baseline|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
10855181|NCT00327340|BG002|Baseline|Total|Total of all reporting groups
10855182|NCT00327340|FG000|Participant Flow|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
10855183|NCT00327340|FG001|Participant Flow|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
10855184|NCT00327340|OG000|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
10855185|NCT00327340|OG001|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
10855186|NCT00327340|OG000|Outcome|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
10855187|NCT00327340|OG001|Outcome|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
10855188|NCT00327340|EG000|Reported Event|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
10855189|NCT00327340|EG001|Reported Event|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
10855190|NCT00327392|BG000|Baseline|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
11344157|NCT04094870|FG000|Participant Flow|Antidepressant Medication|"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table~Sertraline: daily SSRI (Sertraline 25mg)"
11344158|NCT04094870|FG001|Participant Flow|Interpersonal Therapy|"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization~Interpersonal therapy: 11 sessions over a 24-week period"
11344159|NCT04094870|OG000|Outcome|Approached Patients|Eligible patients approached for participation
11344160|NCT04094870|OG000|Outcome|Approached Patients Who Completed Pre-Screening EPDS|Potentially eligible patients who underwent pre-screening with EPDS
11344161|NCT04094870|OG000|Outcome|All Participants With an EPDS >/=6|Women eligible for the MINI based on an EPDS >/=6
11344162|NCT04094870|OG000|Outcome|Women Who Met Diagnostic Criteria by MINI and Agreed to Participate in the Study|Eligible women diagnosed with anxiety or depression based on the MINI who agree to participate
11344163|NCT04094870|OG000|Outcome|Antidepressant Medication|"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table~Sertraline: daily SSRI (Sertraline 25mg)"
11344164|NCT04094870|OG001|Outcome|Interpersonal Therapy|"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization~Interpersonal therapy: 11 sessions over a 24-week period"
11344165|NCT04094870|OG000|Outcome|Women Assigned to the Antidepressant Medication Arm|All women who were randomized to the medication arm
11344166|NCT04094870|OG000|Outcome|All Women Assigned to the Antidepressant Medication Arm|All women who were randomized to the medication arm
11344167|NCT04094870|OG000|Outcome|All Women Assigned to the Therapy Arm|Women who were randomized to the interpersonal therapy arm
11344168|NCT04094870|EG000|Reported Event|Antidepressant Medication|"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table~Sertraline: daily SSRI (Sertraline 25mg)"
11344169|NCT04094870|EG001|Reported Event|Interpersonal Therapy|"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization~Interpersonal therapy: 11 sessions over a 24-week period"
11344170|NCT04096482|BG000|Baseline|Standard Endoscope Followed by Peregrine Drivable ENT Scope|Participants with prior endoscopic sinus surgery (EES) scheduled for nasal endoscopy who are receiving an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable ENT Scope.
11344171|NCT04096482|FG000|Participant Flow|Standard 30° 4mm Endoscope Followed by Peregrine Endoscope|Participants with prior endoscopic sinus surgery (EES) scheduled for nasal endoscopy who are receiving an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable Ear Nose and Throat (ENT) Scope.
10855191|NCT00327392|FG000|Participant Flow|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
10855192|NCT00327392|OG000|Outcome|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
11344172|NCT04096482|OG000|Outcome|Peregrine Drivable ENT Scope|Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
11344173|NCT04096482|OG001|Outcome|Standard 30° 4mm Endoscope|Participants receiving an endoscopy with the standard 30° 4mm endoscope.
11344174|NCT04096482|EG000|Reported Event|Peregrine Drivable ENT Scope|Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
11344175|NCT04096482|EG001|Reported Event|Standard 30° 4mm Endoscope|Participants receiving an endoscopy with the standard 30° 4mm endoscope.
11344176|NCT04098172|BG000|Baseline|Pressure Guidewire Test Subject|"Stable patients with suspected or known CAD, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.~Pressure Guidewire: Fractional Flow Reserve measurement"
11344177|NCT04098172|FG000|Participant Flow|Pressure Guidewire Test Subject|"Stable patients with suspected or known CAD, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.~Pressure Guidewire: Fractional Flow Reserve measurement"
11344178|NCT04098172|OG000|Outcome|Comet Pressure Guidewire Test Subject|"Stable patients with suspected or known Coronary Atherosclerotic Disease (CAD), who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.~Pressure Guidewire: Fractional Flow Reserve measurement"
11344179|NCT04098172|OG001|Outcome|Certus Pressure Guidewire Test Subject|"Stable patients with suspected or known Coronary Atherosclerotic Disease (CAD), who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.~Pressure Guidewire: Fractional Flow Reserve measurement"
11344180|NCT04098172|EG000|Reported Event|Pressure Guidewire Test Subject|"Stable patients with suspected or known CAD, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.~Pressure Guidewire: Fractional Flow Reserve measurement"
11344181|NCT04103515|BG000|Baseline|Subjects Implanted With PCR TKA|"Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty~Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty"
11344182|NCT04103515|BG001|Baseline|Subjects Implanted With PS TKA|"Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty~Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty"
11344183|NCT04103515|BG002|Baseline|Total|Total of all reporting groups
11344184|NCT04103515|FG000|Participant Flow|Subjects Implanted With PCR TKA|"Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty~Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty"
10976483|NCT00940823|BG001|Baseline|Baerveldt Group|Patients received a Baerveldt-350 implant at the time of surgery.
10976484|NCT00940823|BG002|Baseline|Total|Total of all reporting groups
10976485|NCT00940823|FG000|Participant Flow|Ahmed Group|Ahmed FP7 Valve Implant
10976486|NCT00940823|FG001|Participant Flow|Baerveldt Group|Baerveldt-350 Implant
10976487|NCT00940823|OG000|Outcome|Ahmed Group|Ahmed FP7 Valve Implant
10976488|NCT00940823|OG001|Outcome|Baerveldt Group|Baerveldt-350 Implant
10976489|NCT00940823|OG000|Outcome|Ahmed Group|124 patients were randomized to the Ahmed Group.
10976490|NCT00940823|OG001|Outcome|Baerveldt Group|114 patients were randomized to the Ahmed Group.
10976491|NCT00940823|EG000|Reported Event|Ahmed Group|Ahmed FP7 Valve Implant
10976492|NCT00940823|EG001|Reported Event|Baerveldt Group|Baerveldt-350 Implant
10976493|NCT00940875|BG000|Baseline|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
10976494|NCT00940875|BG001|Baseline|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
10976495|NCT00940875|BG002|Baseline|Total|Total of all reporting groups
10976496|NCT00940875|FG000|Participant Flow|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
10976497|NCT00940875|FG001|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E)|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, orally (PO), once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
10976498|NCT00940875|OG000|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
10976499|NCT00940875|OG001|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
10976500|NCT00940875|OG001|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
10976501|NCT00940875|EG000|Reported Event|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
10976502|NCT00940875|EG001|Reported Event|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
10976503|NCT00940888|BG000|Baseline|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
10976504|NCT00940888|FG000|Participant Flow|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
10976505|NCT00940888|OG000|Outcome|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
10976506|NCT00940888|EG000|Reported Event|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
10976507|NCT00940901|BG000|Baseline|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks
10976508|NCT00940901|BG001|Baseline|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then sildenafil 50 mg for weeks 9-16.
10976509|NCT00940901|BG002|Baseline|Total|Total of all reporting groups
11222861|NCT02349542|EG000|Reported Event|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
11222862|NCT02349633|BG000|Baseline|Phase 1 Dose-escalation: PF-06747775 25 mg QD|Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
11222863|NCT02349633|BG001|Baseline|Phase 1 Dose-escalation: PF-06747775 50 mg QD|Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
11344185|NCT04103515|FG001|Participant Flow|Subjects Implanted With PS TKA|"Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty~Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty"
11344186|NCT04103515|OG000|Outcome|Subjects Implanted With PCR TKA|"Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty~Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty"
11344187|NCT04103515|OG001|Outcome|Subjects Implanted With PS TKA|"Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty~Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty"
11344188|NCT04103515|EG000|Reported Event|Subjects Implanted With PCR TKA|"Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty~Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty"
11344189|NCT04103515|EG001|Reported Event|Subjects Implanted With PS TKA|"Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty~Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty"
11344190|NCT04111276|BG000|Baseline|Subjects Diagnosed With Osteoarthritis of the Knee|"Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing.~Breg Osteoarthritis Brace gait fluoroscopy: Gait under fluoroscopy surveillance with brace~Gait fluoroscopy without brace: Gait under fluoroscopy surveillance without brace~JointVue ultrasound: JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones~Computer Tomography: Computer Tomography scan limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur"
11344191|NCT04111276|FG000|Participant Flow|Subjects Diagnosed With Osteoarthritis of the Knee|"Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing.~Breg Osteoarthritis Brace gait fluoroscopy: Gait under fluoroscopy surveillance with brace~Gait fluoroscopy without brace: Gait under fluoroscopy surveillance without brace~JointVue ultrasound: JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones~Computer Tomography: Computer Tomography scan limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur"
11344192|NCT04111276|OG000|Outcome|Subjects Diagnosed With Osteoarthritis of the Knee|"Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing.~Breg Osteoarthritis Brace gait fluoroscopy: Gait under fluoroscopy surveillance with brace~Gait fluoroscopy without brace: Gait under fluoroscopy surveillance without brace~JointVue ultrasound: JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones~Computer Tomography: Computer Tomography scan limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur"
11344193|NCT04111276|EG000|Reported Event|Subjects Diagnosed With Osteoarthritis of the Knee|"Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing.~Breg Osteoarthritis Brace gait fluoroscopy: Gait under fluoroscopy surveillance with brace~Gait fluoroscopy without brace: Gait under fluoroscopy surveillance without brace~JointVue ultrasound: JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones~Computer Tomography: Computer Tomography scan limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur"
11344194|NCT04123405|BG000|Baseline|Group A: 600 mg Acetylcysteine|one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344195|NCT04123405|BG001|Baseline|Group B: 1200 mg Acetylcysteine|two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344196|NCT04123405|BG002|Baseline|Group C: 2400 mg Acetylcysteine|four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
11344197|NCT04123405|BG003|Baseline|Group D: Placebo|four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).
11344198|NCT04123405|BG004|Baseline|Total|Total of all reporting groups
11344199|NCT04123405|FG000|Participant Flow|Group A: 600 mg Acetylcysteine|one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344200|NCT04123405|FG001|Participant Flow|Group B: 1200 mg Acetylcysteine|two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344201|NCT04123405|FG002|Participant Flow|Group C: 2400 mg Acetylcysteine|four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
11344202|NCT04123405|FG003|Participant Flow|Group D: Placebo|four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).
11344203|NCT04123405|OG000|Outcome|Group A: 600 mg Acetylcysteine|one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344204|NCT04123405|OG001|Outcome|Group B: 1200 mg Acetylcysteine|two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344205|NCT04123405|OG002|Outcome|Group C: 2400 mg Acetylcysteine|four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
11344206|NCT04123405|OG003|Outcome|Group D: Placebo|four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344207|NCT04123405|EG000|Reported Event|Group A: 600 mg Acetylcysteine|one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344208|NCT04123405|EG001|Reported Event|Group B: 1200 mg Acetylcysteine|two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
11344209|NCT04123405|EG002|Reported Event|Group C: 2400 mg Acetylcysteine|four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
11344210|NCT04123405|EG003|Reported Event|Group D: Placebo|four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).
10848836|NCT00291694|BG000|Baseline|Celecoxib|Celecoxib for six months
10848837|NCT00291694|BG001|Baseline|Placebo|Placebo for six months
10848838|NCT00291694|BG002|Baseline|Total|Total of all reporting groups
10848839|NCT00291694|FG000|Participant Flow|Placebo|Placebo for 12 months
10848840|NCT00291694|FG001|Participant Flow|Celecoxib|Celecoxib for 12 months
11344211|NCT04128527|BG000|Baseline|Adults, Laryngeal Mask|Adult patients (> 18 years) already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
11344212|NCT04128527|FG000|Participant Flow|Adults, Laryngeal Mask|Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
11344213|NCT04128527|OG000|Outcome|Adults, Laryngeal Mask|Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
11344214|NCT04128527|EG000|Reported Event|Adults, Laryngeal Mask|Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
11344215|NCT04132973|BG000|Baseline|Compassion Guided Self-help|"Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher.~Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010)."
11344216|NCT04132973|FG000|Participant Flow|Compassion Guided Self-help|"Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher.~Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010)."
11344217|NCT04132973|OG000|Outcome|Compassion Guided Self-help|"Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher.~Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010)."
11344218|NCT04132973|EG000|Reported Event|Compassion Guided Self-help|"Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher.~Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010)."
11344219|NCT04133415|BG000|Baseline|Lattice Stereotactic Body Radiation Therapy|-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
11344220|NCT04133415|FG000|Participant Flow|Lattice Stereotactic Body Radiation Therapy|-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
10855193|NCT00327392|EG000|Reported Event|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
11344221|NCT04133415|OG000|Outcome|Lattice Stereotactic Body Radiation Therapy|-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
11344222|NCT04133415|EG000|Reported Event|Lattice Stereotactic Body Radiation Therapy|-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
11344223|NCT04138758|BG000|Baseline|Tiotropium + Olodaterol|Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year.
11344224|NCT04138758|BG001|Baseline|Long-acting Beta Agonist / Inhaled Corticosteroid Therapy|Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year.
11344225|NCT04138758|BG002|Baseline|Total|Total of all reporting groups
11344226|NCT04138758|FG000|Participant Flow|Tiotropium + Olodaterol|Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year.
11344227|NCT04138758|FG001|Participant Flow|Long-acting Beta Agonist / Inhaled Corticosteroid Therapy|Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year.
11344228|NCT04138758|OG000|Outcome|Tiotropium + Olodaterol|Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year.
11344229|NCT04138758|OG001|Outcome|Long-acting Beta Agonist / Inhaled Corticosteroid Therapy|Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year.
11344230|NCT04138758|EG000|Reported Event|Tiotropium + Olodaterol|Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year.
11344231|NCT04138758|EG001|Reported Event|Long-acting Beta Agonist / Inhaled Corticosteroid Therapy|Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year.
10855194|NCT00327444|BG000|Baseline|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
11344232|NCT04147715|BG000|Baseline|Part 1: Placebo|Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1. Two participants assigned to the 100 mg dose cohort also received a single oral dose of matching placebo in a fed state (after a high-fat meal) on Day 14.
11344233|NCT04147715|BG001|Baseline|Part 1: 10 mg S-648414|Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.
11344234|NCT04147715|BG002|Baseline|Part 1: 30 mg S-648414|Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.
11344235|NCT04147715|BG003|Baseline|Part 1: 100 mg S-648414|Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1 followed by a single dose of S-648414 in a fed state (after a high-fat meal) on Day 14.
11344236|NCT04147715|BG004|Baseline|Part 1: 250 mg S-648414|Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.
11344237|NCT04147715|BG005|Baseline|Part 1: 500 mg S-648414|Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.
11344238|NCT04147715|BG006|Baseline|Part 1: 1000 mg S-648414|Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
11344239|NCT04147715|BG007|Baseline|Part 2: Placebo + Midazolam|Participants received matching placebo to S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the placebo dose on Day 14.
11344240|NCT04147715|BG008|Baseline|Part 2: 50 mg S-648414 + Midazolam|Participants received 50 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.
11344241|NCT04147715|BG009|Baseline|Part 2: 30 mg S-648414 + Midazolam|Participants received 30 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.
11344242|NCT04147715|BG010|Baseline|Part 3: 100 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 100 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.
11344243|NCT04147715|BG011|Baseline|Part 3: 200 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 200 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.
11344244|NCT04147715|BG012|Baseline|Total|Total of all reporting groups
11344245|NCT04147715|FG000|Participant Flow|Part 1: Placebo|Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1. Two participants assigned to the 100 mg dose cohort also received a single oral dose of matching placebo in a fed state (after a high-fat meal) on Day 14.
11344246|NCT04147715|FG001|Participant Flow|Part 1: 10 mg S-648414|Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.
11344247|NCT04147715|FG002|Participant Flow|Part 1: 30 mg S-648414|Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.
11344248|NCT04147715|FG003|Participant Flow|Part 1: 100 mg S-648414|Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1 followed by a single dose of S-648414 in a fed state (after a high-fat meal) on Day 14.
11344249|NCT04147715|FG004|Participant Flow|Part 1: 250 mg S-648414|Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.
11344250|NCT04147715|FG005|Participant Flow|Part 1: 500 mg S-648414|Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.
11344251|NCT04147715|FG006|Participant Flow|Part 1: 1000 mg S-648414|Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
11344252|NCT04147715|FG007|Participant Flow|Part 2: Placebo + Midazolam|Participants received matching placebo to S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the placebo dose on Day 14.
11344253|NCT04147715|FG008|Participant Flow|Part 2: 50 mg S-648414 + Midazolam|Participants received 50 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.
11344254|NCT04147715|FG009|Participant Flow|Part 2: 30 mg S-648414 + Midazolam|Participants received 30 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.
11344255|NCT04147715|FG010|Participant Flow|Part 3: 100 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 100 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.
11344256|NCT04147715|FG011|Participant Flow|Part 3: 200 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 200 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.
11344257|NCT04147715|OG000|Outcome|Part 1: Placebo - Fasted|Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.
11344258|NCT04147715|OG001|Outcome|Part 1: Placebo - Fed|Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.
11344259|NCT04147715|OG002|Outcome|Part 1: 10 mg S-648414|Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.
11344260|NCT04147715|OG003|Outcome|Part 1: 30 mg S-648414|Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.
11344261|NCT04147715|OG004|Outcome|Part 1: 100 mg S-648414 Fasted|Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.
11344262|NCT04147715|OG005|Outcome|Part 1: 100 mg S-648414 Fed|Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.
11344263|NCT04147715|OG006|Outcome|Part 1: 250 mg S-648414|Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.
11344264|NCT04147715|OG007|Outcome|Part 1: 500 mg S-648414|Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.
11344265|NCT04147715|OG008|Outcome|Part 1: 1000 mg S-648414|Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
11344266|NCT04147715|OG000|Outcome|Part 2: Midazolam (Day -2)|Participants received a single oral dose of 5 mg midazolam on Day -2.
11344267|NCT04147715|OG001|Outcome|Part 2: Placebo (Days 1-13)|Participants received matching placebo to S-648414 orally once a day on Days 1 to 13.
10855195|NCT00327444|BG001|Baseline|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
11344268|NCT04147715|OG002|Outcome|Part 2: 50 mg S-648414 (Days 1-13)|Participants received 50 mg S-648414 orally once a day on Days 1 to 13.
11344269|NCT04147715|OG003|Outcome|Part 2: 30 mg S-648414 (Days 1-13)|Participants received 30 mg S-648414 orally once a day on Days 1 to 13.
11344270|NCT04147715|OG004|Outcome|Part 2: Placebo + Midazolam (Day 14)|Participants received matching placebo to S-648414 and a single oral dose of 5 mg midazolam on Day 14.
11344271|NCT04147715|OG005|Outcome|Part 2: 50 mg S-648414 + Midazolam (Day 14)|Participants received 50 mg S-648414 and a single oral dose of 5 mg midazolam on Day 14.
11344272|NCT04147715|OG006|Outcome|Part 2: 30 mg S-648414 + Midazolam (Day 14)|Participants received 30 mg S-648414 and a single oral dose of 5 mg midazolam on Day 14.
11344273|NCT04147715|OG000|Outcome|Part 3: Dolutegravir (100 mg S-648414 Group)|Participants assigned to the 100 mg S-648414 dose group received 50 mg dolutegravir orally once a day on Days 1 to 7.
11344274|NCT04147715|OG001|Outcome|Part 3: 100 mg S-648414|Participants received 100 mg S-648414 orally once a day on Days 15 to 21.
11344275|NCT04147715|OG002|Outcome|Part 3: 100 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.
11344276|NCT04147715|OG003|Outcome|Part 3: Dolutegravir (200 mg S-648414 Group)|Participants assigned to the 200 mg S-648414 dose group received 50 mg dolutegravir once a day on Days 1 to 7.
11344277|NCT04147715|OG004|Outcome|Part 3: 200 mg S-648414|Participants received 200 mg S-648414 orally once a day on Days 15 to 21.
11344278|NCT04147715|OG005|Outcome|Part 3: 200 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir once a day co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.
11344279|NCT04147715|OG000|Outcome|Part 3: 100 mg S-648414|Participants received 100 mg S-648414 orally once a day on Days 15 to 21.
11344280|NCT04147715|OG001|Outcome|Part 3: 100 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.
10855196|NCT00327444|BG002|Baseline|Total|Total of all reporting groups
10855197|NCT00327444|FG000|Participant Flow|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
10855198|NCT00327444|FG001|Participant Flow|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
11344281|NCT04147715|OG002|Outcome|Part 3: 200 mg S-648414|Participants received 200 mg S-648414 orally once a day on Days 15 to 21.
11344282|NCT04147715|OG003|Outcome|Part 3: 200 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir once a day co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.
11344283|NCT04147715|OG002|Outcome|Part 3: Dolutegravir (200 mg S-648414 Group)|Participants assigned to the 200 mg S-648414 dose group received 50 mg dolutegravir once a day on Days 1 to 7.
11344284|NCT04147715|OG000|Outcome|Part 1: 10 mg S-648414|Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.
11344285|NCT04147715|OG001|Outcome|Part 1: 30 mg S-648414|Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.
11344286|NCT04147715|OG002|Outcome|Part 1: 100 mg S-648414 Fasted|Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.
11344287|NCT04147715|OG003|Outcome|Part 1: 100 mg S-648414 Fed|Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.
11007022|NCT01089062|OG000|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
11344288|NCT04147715|OG004|Outcome|Part 1: 250 mg S-648414|Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.
11344289|NCT04147715|OG005|Outcome|Part 1: 500 mg S-648414|Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.
11344290|NCT04147715|OG006|Outcome|Part 1: 1000 mg S-648414|Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
11344291|NCT04147715|OG000|Outcome|Part 2: 30 mg S-648414 + Midazolam|Participants received 30 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.
11344292|NCT04147715|OG001|Outcome|Part 2: 50 mg S-648414 + Midazolam|Participants received 50 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.
11344293|NCT04147715|OG000|Outcome|Part 2: Midazolam (30 mg S-648414 Group)|Participants assigned to the 30 mg S-648414 dose group received a single oral dose of 5 mg midazolam on Day -2
11344294|NCT04147715|OG001|Outcome|Part 2: 30 mg S-648414 + Midazolam|Participants received 30 mg S-648414 and a single oral dose of 5 mg midazolam on Day 14.
11344295|NCT04147715|OG002|Outcome|Part 2: Midazolam (50 mg S-648414 Group)|Participants assigned to the 50 mg S-648414 dose group received a single oral dose of 5 mg midazolam on Day -2
11344296|NCT04147715|OG003|Outcome|Part 2: 50 mg S-648414 + Midazolam|Participants received 50 mg S-648414 and a single oral dose of 5 mg midazolam on Day 14.
11344297|NCT04147715|OG000|Outcome|Part 1: Placebo|Participants received a single oral dose of matching placebo in a fasted state on Day 1.
11344298|NCT04147715|OG001|Outcome|Part 1: 10 mg S-648414|Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.
11344299|NCT04147715|OG002|Outcome|Part 1: 30 mg S-648414|Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.
11344300|NCT04147715|OG003|Outcome|Part 1: 100 mg S-648414|Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.
11344301|NCT04147715|OG002|Outcome|Part 1: 100 mg S-648414|Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.
11344302|NCT04147715|OG003|Outcome|Part 1: 250 mg S-648414|Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.
11344303|NCT04147715|OG004|Outcome|Part 1: 500 mg S-648414|Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.
11344304|NCT04147715|OG005|Outcome|Part 1: 1000 mg S-648414|Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
11344305|NCT04147715|EG000|Reported Event|Part 1: Placebo - Fasted|Participants received a single oral dose of matching placebo in a fasted state on Day 1.
10855199|NCT00327444|OG000|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
10855200|NCT00327444|OG001|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
10855201|NCT00327444|OG000|Outcome|Double Blind (DB) Period|Participants with advanced ovarian cancer administered placebo or 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period.
11007023|NCT01089062|OG001|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
11222864|NCT02349633|BG002|Baseline|Phase 1 Dose-escalation: PF-06747775 150 mg QD|Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
11222865|NCT02349633|BG003|Baseline|Phase 1 Dose-escalation: PF-06747775 275 mg QD|Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
11222866|NCT02349633|BG004|Baseline|Phase 1 Dose-escalation: PF-06747775 300 mg QD|Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
11222867|NCT02349633|BG005|Baseline|Phase 1 Dose-escalation: PF-06747775 450 mg QD|Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
11222868|NCT02349633|BG006|Baseline|Phase 1 Dose-escalation: PF-06747775 600 mg QD|Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
11222869|NCT02349633|BG007|Baseline|PF-06747775 200 mg QD Group|Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
11222870|NCT02349633|BG008|Baseline|Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD|Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
11222871|NCT02349633|BG009|Baseline|Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD|Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
11222872|NCT02349633|BG010|Baseline|Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin|Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
11222873|NCT02349633|BG011|Baseline|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222874|NCT02349633|BG012|Baseline|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222875|NCT02349633|BG013|Baseline|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11222876|NCT02349633|BG014|Baseline|Total|Total of all reporting groups
11222877|NCT02349633|FG000|Participant Flow|Phase 1 Dose-escalation: PF-06747775 25 mg QD|Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
11222878|NCT02349633|FG001|Participant Flow|Phase 1 Dose-escalation: PF-06747775 50 mg QD|Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
11222879|NCT02349633|FG002|Participant Flow|Phase 1 Dose-escalation: PF-06747775 150 mg QD|Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
11222880|NCT02349633|FG003|Participant Flow|Phase 1 Dose-escalation: PF-06747775 275 mg QD|Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
11222881|NCT02349633|FG004|Participant Flow|Phase 1 Dose-escalation: PF-06747775 300 mg QD|Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
11222882|NCT02349633|FG005|Participant Flow|Phase 1 Dose-escalation: PF-06747775 450 mg QD|Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
11222883|NCT02349633|FG006|Participant Flow|Phase 1 Dose-escalation: PF-06747775 600 mg QD|Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
11344306|NCT04147715|EG001|Reported Event|Part 1: Placebo - Fed|Participants received a single dose of matching placebo in a fed state (after a high-fat meal) on Day 14.
11344307|NCT04147715|EG002|Reported Event|Part 1: 10 mg S-648414|Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.
11344308|NCT04147715|EG003|Reported Event|Part 1: 30 mg S-648414|Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.
11344309|NCT04147715|EG004|Reported Event|Part 1: 100 mg S-648414 Fasted|Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.
11344310|NCT04147715|EG005|Reported Event|Part 1: 100 mg S-648414 Fed|Participants received a single oral dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.
11344311|NCT04147715|EG006|Reported Event|Part 1: 250 mg S-648414|Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.
11344312|NCT04147715|EG007|Reported Event|Part 1: 500 mg S-648414|Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.
11344313|NCT04147715|EG008|Reported Event|Part 1: 1000 mg S-648414|Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
11344314|NCT04147715|EG009|Reported Event|Part 2: Midazolam (Day -2)|Participants received a single oral dose of 5 mg midazolam on Day -2
11344315|NCT04147715|EG010|Reported Event|Part 2: Placebo (Days 1-13)|Participants received matching placebo to S-648414 once a day on Days 1 to 13.
11344316|NCT04147715|EG011|Reported Event|Part 2: 50 mg S-648414 (Days 1-13)|Participants received 50 mg S-648414 once a day on Days 1 to 13.
11344317|NCT04147715|EG012|Reported Event|Part 2: 30 mg S-648414 (Days 1-13)|Participants received 30 mg S-648414 once a day on Days 1 to 13.
10848841|NCT00291694|OG000|Outcome|Celecoxib|Randomized to receive celecoxib daily for 12 months
11344318|NCT04147715|EG013|Reported Event|Part 2: Placebo + Midazolam (Day 14)|Participants received matching placebo to S-648414 and a single oral dose of 5 mg midazolam on Day 14.
11344319|NCT04147715|EG014|Reported Event|Part 2: 50 mg S-648414 + Midazolam (Day 14)|Participants received 50 mg S-648414 and a single oral dose of 5 mg midazolam on Day 14.
11344320|NCT04147715|EG015|Reported Event|Part 2: 30 mg S-648414 + Midazolam (Day 14)|Participants received 30 mg S-648414 and a single oral dose of 5 mg midazolam on Day 14.
11344321|NCT04147715|EG016|Reported Event|Part 3: Group I Dolutegravir|Participants received 50 mg dolutegravir orally once a day on Days 1 to 7.
11344322|NCT04147715|EG017|Reported Event|Part 3: 100 mg S-648414|Participants received 100 mg S-648414 orally once a day on Days 15 to 21.
11344323|NCT04147715|EG018|Reported Event|Part 3: 100 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.
11344324|NCT04147715|EG019|Reported Event|Part 3: Dolutegravir|Participants received 50 mg dolutegravir once a day on Days 1 to 7.
11344325|NCT04147715|EG020|Reported Event|Part 3: 200 mg S-648414|Participants received 200 mg S-648414 orally once a day on Days 15 to 21.
11344326|NCT04147715|EG021|Reported Event|Part 3: 200 mg S-648414 + Dolutegravir|Participants received 50 mg dolutegravir once a day co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.
11344327|NCT04154605|BG000|Baseline|ClariFix|"Cryotherapy of the nasal passages with the ClariFix device.~ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device."
11344328|NCT04154605|BG001|Baseline|Sham|"Sham cryotherapy of the nasal passages with the ClariFix device~Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device."
11344329|NCT04154605|BG002|Baseline|Total|Total of all reporting groups
11344330|NCT04154605|FG000|Participant Flow|ClariFix|"Cryotherapy of the nasal passages with the ClariFix device.~ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device."
11344331|NCT04154605|FG001|Participant Flow|Sham|"Sham cryotherapy of the nasal passages with the ClariFix device~Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device."
11344332|NCT04154605|OG000|Outcome|ClariFix|"Cryotherapy of the nasal passages with the ClariFix device.~ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device."
11344333|NCT04154605|OG001|Outcome|Sham|"Sham cryotherapy of the nasal passages with the ClariFix device~Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device."
11344334|NCT04154605|EG000|Reported Event|ClariFix|"Cryotherapy of the nasal passages with the ClariFix device.~ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device."
11344335|NCT04154605|EG001|Reported Event|Sham|"Sham cryotherapy of the nasal passages with the ClariFix device~Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device."
11344336|NCT04160091|BG000|Baseline|FX006 32mg in Glenohumeral OA Population|"Single intra-articular (IA) injection~FX006: Single intra-articular injection"
11344337|NCT04160091|BG001|Baseline|Normal Saline in Glenohumeral OA Population|"Single intra-articular (IA) injection~Normal Saline: Single intra-articular injection"
11344338|NCT04160091|BG002|Baseline|FX006 32mg in Adhesive Capsulitis Population|"Single intra-articular (IA) injection~FX006: Single intra-articular injection"
11344339|NCT04160091|BG003|Baseline|Normal Saline in Adhesive Capsulitis Population|"Single intra-articular (IA) injection~Normal Saline: Single intra-articular injection"
11344340|NCT04160091|BG004|Baseline|Total|Total of all reporting groups
11344341|NCT04160091|FG000|Participant Flow|FX006 32mg in Glenohumeral OA Population|"Single intra-articular (IA) injection~FX006: Single intra-articular injection"
11344342|NCT04160091|FG001|Participant Flow|Normal Saline in Glenohumeral OA Population|"Single intra-articular (IA) injection~Normal Saline: Single intra-articular injection"
11344343|NCT04160091|FG002|Participant Flow|FX006 32mg in Adhesive Capsulitis Population|"Single intra-articular (IA) injection~FX006: Single intra-articular injection"
11344344|NCT04160091|FG003|Participant Flow|Normal Saline in Adhesive Capsulitis Population|"Single intra-articular (IA) injection~Normal Saline: Single intra-articular injection"
11344345|NCT04160091|OG000|Outcome|FX006 32mg in Glenohumeral OA Population|"Single intra-articular (IA) injection~FX006: Single intra-articular injection"
11344346|NCT04160091|OG001|Outcome|Normal Saline in Glenohumeral OA Population|"Single intra-articular (IA) injection~Normal Saline: Single intra-articular injection"
11344347|NCT04160091|OG002|Outcome|FX006 32mg in Adhesive Capsulitis Population|"Single intra-articular (IA) injection~FX006: Single intra-articular injection"
11344348|NCT04160091|OG003|Outcome|Normal Saline in Adhesive Capsulitis Population|"Single intra-articular (IA) injection~Normal Saline: Single intra-articular injection"
11344349|NCT04160091|EG000|Reported Event|FX006 32mg in Glenohumeral OA Population|"Single intra-articular (IA) injection~FX006: Single intra-articular injection"
11344350|NCT04160091|EG001|Reported Event|Normal Saline in Glenohumeral OA Population|"Single intra-articular (IA) injection~Normal Saline: Single intra-articular injection"
11344351|NCT04160091|EG002|Reported Event|FX006 32mg in Adhesive Capsulitis Population|"Single intra-articular (IA) injection~FX006: Single intra-articular injection"
11344352|NCT04160091|EG003|Reported Event|Normal Saline in Adhesive Capsulitis Population|"Single intra-articular (IA) injection~Normal Saline: Single intra-articular injection"
11344353|NCT04160260|BG000|Baseline|300 mg PO Omadacycline|Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
11344354|NCT04160260|FG000|Participant Flow|300 mg PO Omadacycline|Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
11344355|NCT04160260|OG000|Outcome|300 mg PO Omadacycline|Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
11344356|NCT04160260|EG000|Reported Event|300 mg PO Omadacycline|Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
11344357|NCT04164758|BG000|Baseline|Placebo|Two encapsulated placebo tablets, taken once daily
11344358|NCT04164758|BG001|Baseline|Quetiapine|Quetiapine starting dose 25 mg once daily (provided as 1 × 25 mg quetiapine immediate release encapsulated tablet plus 1 placebo encapsulated tablet), with the possibility to increase the dose to 50 mg (2 × 25 mg quetiapine immediate release encapsulated tablets) or 100 mg (2 × 50 mg quetiapine immediate release encapsulated tablets) taken once daily, based on clinical response.
11344359|NCT04164758|BG002|Baseline|Pimavanserin 34 mg|Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
11344360|NCT04164758|BG003|Baseline|Total|Total of all reporting groups
11344361|NCT04164758|FG000|Participant Flow|Placebo|Two encapsulated placebo tablets, taken once daily
11344362|NCT04164758|FG001|Participant Flow|Quetiapine|Quetiapine starting dose 25 mg once daily (provided as 1 × 25 mg quetiapine immediate release encapsulated tablet plus 1 placebo encapsulated tablet), with the possibility to increase the dose to 50 mg (2 × 25 mg quetiapine immediate release encapsulated tablets) or 100 mg (2 × 50 mg quetiapine immediate release encapsulated tablets) taken once daily, based on clinical response.
11344363|NCT04164758|FG002|Participant Flow|Pimavanserin 34 mg|Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
11344364|NCT04164758|OG000|Outcome|Placebo|Two encapsulated placebo tablets, taken once daily
11344365|NCT04164758|OG001|Outcome|Quetiapine|Quetiapine starting dose 25 mg once daily (provided as 1 × 25 mg quetiapine immediate release encapsulated tablet plus 1 placebo encapsulated tablet), with the possibility to increase the dose to 50 mg (2 × 25 mg quetiapine immediate release encapsulated tablets) or 100 mg (2 × 50 mg quetiapine immediate release encapsulated tablets) taken once daily, based on clinical response.
11344366|NCT04164758|OG002|Outcome|Pimavanserin 34 mg|Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
11344367|NCT04164758|EG000|Reported Event|Placebo|Two encapsulated placebo tablets, taken once daily
11344368|NCT04164758|EG001|Reported Event|Quetiapine|Quetiapine starting dose 25 mg once daily (provided as 1 × 25 mg quetiapine immediate release encapsulated tablet plus 1 placebo encapsulated tablet), with the possibility to increase the dose to 50 mg (2 × 25 mg quetiapine immediate release encapsulated tablets) or 100 mg (2 × 50 mg quetiapine immediate release encapsulated tablets) taken once daily, based on clinical response.
11344369|NCT04164758|EG002|Reported Event|Pimavanserin 34 mg|Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
11344370|NCT04165031|BG000|Baseline|LY3499446 Phase 1 Cohort A1 (High Dose)|Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
11344371|NCT04165031|BG001|Baseline|LY3499446 Phase 1 Cohort AO (Mid Dose)|Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
11344372|NCT04165031|BG002|Baseline|LY3499446 Phase 1 Cohort A-2 (Low Dose)|Participants received low dose LY 3499446 as oral monotherapy once QD in 21-day cycles.
10848842|NCT00291694|OG001|Outcome|Placebo|Randomized to receive placebo daily for 12 months
10848843|NCT00291694|OG000|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
10848844|NCT00291694|OG001|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
11344373|NCT04165031|BG003|Baseline|LY3499446 + Combination Drug Phase 1|"LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).~The trial was terminated prior to initiation of this portion."
11344374|NCT04165031|BG004|Baseline|LY3499446 Monotherapy + Combination Drug Phase 2|"LY3499446 monotherapy orally. LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).~The trial was terminated prior to initiation of this portion."
11344375|NCT04165031|BG005|Baseline|Docetaxel Phase 2|"Docetaxel IV infusion.~The trial was terminated prior to initiation of this portion."
11344376|NCT04165031|BG006|Baseline|Total|Total of all reporting groups
11344377|NCT04165031|FG000|Participant Flow|LY3499446 Phase 1 Cohort A1 (High Dose)|Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
11344378|NCT04165031|FG001|Participant Flow|LY3499446 Phase 1 Cohort AO (Mid Dose)|Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
11344379|NCT04165031|FG002|Participant Flow|LY3499446 Phase 1 Cohort A-2 (Low Dose)|Participants received low dose LY 3499446 as oral monotherapy once daily (QD) in 21-day cycles.
11344380|NCT04165031|FG003|Participant Flow|LY3499446 + Combination Drug Phase 1|"LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).~The trial was terminated prior to initiation of this portion."
11344381|NCT04165031|FG004|Participant Flow|LY3499446 Monotherapy + Combination Drug Phase 2|"LY3499446 monotherapy orally. LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).~The trial was terminated prior to initiation of this portion."
11344382|NCT04165031|FG005|Participant Flow|Docetaxel Phase 2|"Docetaxel IV infusion.~The trial was terminated prior to initiation of this portion."
11344383|NCT04165031|OG000|Outcome|LY3499446 Phase 1 Cohort A1 (High Dose)|Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
11344384|NCT04165031|OG001|Outcome|LY3499446 Phase 1 Cohort AO (Mid Dose)|Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
11344385|NCT04165031|OG002|Outcome|LY3499446 Phase 1 Cohort A-2 (Low Dose)|Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
11344386|NCT04165031|OG000|Outcome|LY3499446 Monotherapy + Combination Drugs Phase 2|LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).
11344387|NCT04165031|OG001|Outcome|Docetaxel Phase 2|Docetaxel IV infusion.
11344388|NCT04165031|OG000|Outcome|LY3499446 and Abemaciclib Phase 1|LY3499446 in combination with abemaciclib orally.
11344389|NCT04165031|OG000|Outcome|LY3499446 and Cetuximab Phase 1|LY3499446 in combination with cetuximab intravenously (IV).
11344390|NCT04165031|OG000|Outcome|LY3499446 Monotherapy and Erlotinib Phase 1|LY3499446 in combination with erlotinib orally.
11344391|NCT04165031|OG001|Outcome|LY3499446 Phase 1 Cohort AO (Mid Dose)|Participant received mid dose LY3499446 as oral monotherapy QOD in 21-day cycles.
11344392|NCT04165031|OG002|Outcome|LY3499446 Phase 1 Cohort A-2 (Low Dose)|Participants received low dose LY3499446 as oral monotherapy QD in 21-day cycles in 21-day cycles.
11344393|NCT04165031|EG000|Reported Event|LY3499446 Phase 1 Cohort A1 (High Dose)|Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
11344394|NCT04165031|EG001|Reported Event|LY3499446 Phase 1 Cohort AO (Mid Dose)|Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
11344395|NCT04165031|EG002|Reported Event|LY3499446 Phase 1 Cohort A-2 (Low Dose)|Participants received low dose LY3499446 as monotherapy orally once QD in 21-day cycles.
11344396|NCT04166032|BG000|Baseline|ANICGM|"non-invasive continuous glucose monitoring device~Alertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)"
11344397|NCT04166032|FG000|Participant Flow|ANICGM|"non-invasive continuous glucose monitoring device~Alertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)"
11344398|NCT04166032|OG000|Outcome|ANICGM|"non-invasive continuous glucose monitoring device~Alertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)"
11344399|NCT04166032|EG000|Reported Event|ANICGM|"non-invasive continuous glucose monitoring device~Alertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)"
11344400|NCT04171414|BG000|Baseline|"CT-P17 SC AI (Adalimumab)"|The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
11344401|NCT04171414|FG000|Participant Flow|"CT-P17 SC AI (Adalimumab)"|The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
11344402|NCT04171414|OG000|Outcome|"CT-P17 SC AI (Adalimumab)"|The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
11344403|NCT04171414|EG000|Reported Event|"CT-P17 SC AI (Adalimumab)"|The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
11344404|NCT04175808|BG000|Baseline|Part B|"Participants with a maximum observed OM plasma concentration ≤ 350 ng/mL in Part A were randomly assigned to receive a single dose of each the following 3 treatments in one of six treatment sequences:~Placebo~50 mg omecamtiv mecarbil~400 mg moxifloxacin Each treatment was separated by a washout of at least 7 days."
11344405|NCT04175808|FG000|Participant Flow|Part A|After an overnight fast of at least 10 hours participants received a single oral dose of 25 mg omecamtiv mecarbil on Day 1.
11344406|NCT04175808|FG001|Participant Flow|Part B: Placebo/OM/Moxifloxacin|Participants received a single dose of placebo oral solution in Period 1, 50 mg omecamtiv mecarbil oral solution in Period 2 and 400 mg moxifloxacin oral tablet in Period 3. Each treatment was separated by a washout period of at least 7 days.
11344407|NCT04175808|FG002|Participant Flow|Part B: OM/Moxifloxacin/Placebo|Participants received a single dose of 50 mg omecamtiv mecarbil oral solution in Period 1, 400 mg moxifloxacin oral tablet in Period 2, and placebo oral solution in Period 3. Each treatment was separated by a washout period of at least 7 days.
11344408|NCT04175808|FG003|Participant Flow|Part B: Moxifloxacin/Placebo/OM|Participants received a single dose of 400 mg moxifloxacin oral tablet in Period 1, placebo oral solution in Period 2, and 50 mg omecamtiv mecarbil oral solution in Period 3. Each treatment was separated by a washout period of at least 7 days.
11344409|NCT04175808|FG004|Participant Flow|Part B: Placebo/Moxifloxacin/OM|Participants received a single dose of placebo oral solution in Period 1, 400 mg moxifloxacin oral tablet in Period 2, and 50 mg omecamtiv mecarbil oral solution in Period 3. Each treatment was separated by a washout period of at least 7 days.
11344410|NCT04175808|FG005|Participant Flow|Part B: Moxifloxacin/OM/Placebo|Participants received a single dose of 400 mg moxifloxacin oral tablet in Period 1, 50 mg omecamtiv mecarbil oral solution in Period 2, and placebo oral solution in Period 3. Each treatment was separated by a washout period of at least 7 days.
11344411|NCT04175808|FG006|Participant Flow|Part B: OM/Placebo/Moxifloxacin|Participants received a single dose of 50 mg omecamtiv mecarbil oral solution in Period 1, placebo oral solution in Period 2, and 400 mg moxifloxacin oral tablet in Period 3. Each treatment was separated by a washout period of at least 7 days.
11344412|NCT04175808|OG000|Outcome|Part B: Omecamtiv Mecarbil 50 mg|Participants received a single oral dose of 50 mg OM on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
10855202|NCT00327444|OG001|Outcome|Open-Label (OL) Period|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
11222884|NCT02349633|FG007|Participant Flow|PF-06747775 200 mg QD Group|Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
10855203|NCT00327444|EG000|Reported Event|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
10855204|NCT00327444|EG001|Reported Event|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
10855205|NCT00327470|BG000|Baseline|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
10976510|NCT00940901|FG000|Participant Flow|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
11222885|NCT02349633|FG008|Participant Flow|Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD|Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
11222886|NCT02349633|FG009|Participant Flow|Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD|Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
11222887|NCT02349633|FG010|Participant Flow|Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin|Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
11222888|NCT02349633|FG011|Participant Flow|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222889|NCT02349633|FG012|Participant Flow|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222890|NCT02349633|FG013|Participant Flow|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11222891|NCT02349633|OG000|Outcome|Phase 1 Dose-escalation: PF-06747775 25 mg QD|Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
11222892|NCT02349633|OG001|Outcome|Phase 1 Dose-escalation: PF-06747775 50 mg QD|Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
11222893|NCT02349633|OG002|Outcome|Phase 1 Dose-escalation: PF-06747775 150 mg QD|Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
11222894|NCT02349633|OG003|Outcome|Phase 1 Dose-escalation: PF-06747775 275 mg QD|Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
11222895|NCT02349633|OG004|Outcome|Phase 1 Dose-escalation: PF-06747775 300 mg QD|Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
11222896|NCT02349633|OG005|Outcome|Phase 1 Dose-escalation: PF-06747775 450 mg QD|Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
11007024|NCT01089062|OG002|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
11222897|NCT02349633|OG006|Outcome|Phase 1 Dose-escalation: PF-06747775 600 mg QD|Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
11222898|NCT02349633|OG007|Outcome|Japan LIC|Japan LIC included Japan LIC RP2D cohort and Japan LIC PK cohort. Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 (Japan LIC RP2D cohort) or PF-06747775 100 mg on Day -7 (Japan LIC PK cohort) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycles. (up to a maximum of 61 weeks).
11222899|NCT02349633|OG008|Outcome|Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD|Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
11222900|NCT02349633|OG009|Outcome|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11344413|NCT04175808|OG000|Outcome|Part B: Moxifloxacin 400 mg|Participants received a single dose of 400 mg moxifloxacin on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344414|NCT04175808|OG000|Outcome|Part A: Omecamtiv Mecarbil 25 mg|After an overnight fast of at least 10 hours participants received a single oral dose of 25 mg omecamtiv mecarbil on Day 1.
11344415|NCT04175808|OG001|Outcome|Part B: Placebo|Participants received a single oral dose of placebo on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344416|NCT04175808|OG002|Outcome|Part B: Omecamtiv Mecarbil 50 mg|Participants received a single oral dose of 50 mg OM on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344417|NCT04175808|OG003|Outcome|Part B: Moxifloxacin 400 mg|Participants received a single dose of 400 mg moxifloxacin on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344418|NCT04175808|OG001|Outcome|Part B: Moxifloxacin 400 mg|Participants received a single dose of 400 mg moxifloxacin on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344419|NCT04175808|OG002|Outcome|Part B: Placebo|Participants received a single oral dose of placebo on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344420|NCT04175808|OG001|Outcome|Part B: Moxifloxacin 400 mg|Participants received a single dose of 400 mg moxifloxacin on day 1 of treatment period 1, 2, or 3, depending on sequence assignment
11344421|NCT04175808|EG000|Reported Event|Part A: Omecamtiv Mecarbil 25 mg|After an overnight fast of at least 10 hours participants received a single oral dose of 25 mg omecamtiv mecarbil on Day 1.
11344422|NCT04175808|EG001|Reported Event|Part B: Placebo|Participants received a single oral dose of placebo on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344423|NCT04175808|EG002|Reported Event|Part B: Omecamtiv Mecarbil 50 mg|Participants received a single oral dose of 50 mg OM on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344424|NCT04175808|EG003|Reported Event|Part B: Moxifloxacin 400 mg|Participants received a single dose of 400 mg moxifloxacin on day 1 of treatment period 1, 2, or 3, depending on sequence assignment.
11344425|NCT04175808|EG004|Reported Event|Overall|ALL TREATED SUBJECTS
11344426|NCT04178720|BG000|Baseline|Biofinity|Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
11344427|NCT04178720|BG001|Baseline|LID018869|Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
11344428|NCT04178720|BG002|Baseline|Total|Total of all reporting groups
11344429|NCT04178720|FG000|Participant Flow|Biofinity|Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
11344430|NCT04178720|FG001|Participant Flow|LID018869|Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
11344431|NCT04178720|OG000|Outcome|Biofinity|Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours onl, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
11344432|NCT04178720|OG001|Outcome|LID018869|Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
11344433|NCT04178720|EG000|Reported Event|Pre-treatment|Events reported in this group occurred prior to exposure to the study contact lenses
11344434|NCT04178720|EG001|Reported Event|LID018869 Ocular|Events reported in this group occurred while exposed to lehfilcon A contact lenses
11344435|NCT04178720|EG002|Reported Event|LID018869 Nonocular/Systemic|Events reported in this group occurred while exposed to lehfilcon A contact lenses
11344436|NCT04178720|EG003|Reported Event|Biofinity Ocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
11344437|NCT04178720|EG004|Reported Event|Biofinity Nonocular/Systemic|Events reported in this group occurred while exposed to comfilcon A contact lenses
11344438|NCT04184297|BG000|Baseline|Tiotropium+Olodaterol|All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
11344439|NCT04184297|BG001|Baseline|LABA/LAMA/ICS|All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
11344440|NCT04184297|BG002|Baseline|Total|Total of all reporting groups
11344441|NCT04184297|FG000|Participant Flow|Tiotropium+Olodaterol|All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
11344442|NCT04184297|FG001|Participant Flow|LABA/LAMA/ICS|All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
11344443|NCT04184297|OG000|Outcome|Tiotropium+Olodaterol|All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
11344444|NCT04184297|OG001|Outcome|LABA/LAMA/ICS|All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
11344445|NCT04184297|EG000|Reported Event|Tiotropium+Olodaterol|All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
11344446|NCT04184297|EG001|Reported Event|LABA/LAMA/ICS|All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
11344447|NCT04189848|BG000|Baseline|Overall Study|Participants were to receive s.c. injections of 0.25 mg semaglutide and 0.75 mg dulaglutide each from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
11344448|NCT04189848|FG000|Participant Flow|Sequence A: Semaglutide (Right) Then Dulaglutide (Left)|Participants were to receive a subcutaneous (s.c.) injection of 0.25 milligrams (mg) of semaglutide on the right side of abdomen (in treatment period 1); followed by an s.c. injection of 0.75 mg of dulaglutide product on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11344449|NCT04189848|FG001|Participant Flow|Sequence B: Semaglutide (Left) Then Dulaglutide (Right)|Participants were to receive an s.c. injection of 0.25 mg of semaglutide on the left side of abdomen (in treatment period 1); followed by an s.c. injection of 0.75 mg of dulaglutide on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11344450|NCT04189848|FG002|Participant Flow|Sequence C: Dulaglutide (Right) Then Semaglutide (Left)|Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on the right side of abdomen (in treatment period 1); followed by an s.c. injection of 0.25 mg of semaglutide on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11344451|NCT04189848|FG003|Participant Flow|Sequence D: Dulaglutide (Left) Then Semaglutide (Right)|Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on the left side of abdomen (in treatment period 1); followed by an s.c. injection of 0.25 mg of semaglutide on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
10976511|NCT00940901|FG001|Participant Flow|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
10976512|NCT00940901|OG000|Outcome|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
10976513|NCT00940901|OG001|Outcome|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
10976514|NCT00940901|EG000|Reported Event|Sildenafil Phase 1|Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
10976515|NCT00940901|EG001|Reported Event|Placebo Then Sildenafil Phase 1|Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
10976516|NCT00940901|EG002|Reported Event|Sildenafil Phase 2|Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
11344452|NCT04189848|OG000|Outcome|Semaglutide|Participants were to receive an s.c. injection of 0.25 mg of semaglutide on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
11344453|NCT04189848|OG001|Outcome|Dulaglutide|Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
11344454|NCT04189848|EG000|Reported Event|Overall Study|Participants were to receive s.c. injections of 0.25 mg semaglutide and 0.75 mg dulaglutide each from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
11344455|NCT04210232|BG000|Baseline|TECNIS Toric II|Study Lens
10976517|NCT00940901|EG003|Reported Event|Placebo Then Sildenafil Phase 2|Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
10976518|NCT00940927|BG000|Baseline|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
10976519|NCT00940927|FG000|Participant Flow|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
10976520|NCT00940927|OG000|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
11344456|NCT04210232|FG000|Participant Flow|TECNIS Toric II|Study Lens
11344457|NCT04210232|OG000|Outcome|TECNIS Toric II|Study Lens
11344458|NCT04210232|EG000|Reported Event|TECNIS Toric II|Study Lens
11344459|NCT04211909|BG000|Baseline|SOF/VEL|Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
11344460|NCT04211909|BG001|Baseline|SOF/VEL/VOX|Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
11344461|NCT04211909|BG002|Baseline|Total|Total of all reporting groups
10848845|NCT00291694|EG000|Reported Event|Celecoxib|Randomized to receive celecoxib daily for 12 months
10976521|NCT00940927|EG000|Reported Event|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
10976522|NCT00940992|BG000|Baseline|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
10976523|NCT00940992|BG001|Baseline|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
10976524|NCT00940992|BG002|Baseline|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
10976525|NCT00940992|BG003|Baseline|Total|Total of all reporting groups
10976526|NCT00940992|FG000|Participant Flow|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
11344462|NCT04211909|FG000|Participant Flow|SOF/VEL|Participants with chronic hepatitis C virus (HCV) infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with interferon (IFN)-based treatments received sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks.
11344463|NCT04211909|FG001|Participant Flow|SOF/VEL/VOX|Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least a 4 weeks duration received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) FDC tablet orally once daily for 12 weeks.
11344464|NCT04211909|OG000|Outcome|SOF/VEL|Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
11344465|NCT04211909|OG001|Outcome|SOF/VEL/VOX|Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
11344466|NCT04211909|EG000|Reported Event|SOF/VEL|Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
11344467|NCT04211909|EG001|Reported Event|SOF/VEL/VOX|Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A-DAA based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
11344468|NCT04218110|BG000|Baseline|Project X 26ml|"3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344469|NCT04218110|BG001|Baseline|Project X 10.5ml|"3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344470|NCT04218110|BG002|Baseline|Project X 5.1ml|"3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344471|NCT04218110|BG003|Baseline|Prevantics Maxi Swabstick|"3.15% w/v CHG/70% v/v IPA contained within pre-saturated applicator. 5.1ml volume. Single use.~Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects"
11344472|NCT04218110|BG004|Baseline|Total|Total of all reporting groups
11344473|NCT04218110|FG000|Participant Flow|Project X 26ml|"3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344474|NCT04218110|FG001|Participant Flow|Project X 10.5ml|"3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344475|NCT04218110|FG002|Participant Flow|Project X 5.1ml|"3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344476|NCT04218110|FG003|Participant Flow|Prevantics Maxi Swabstick|"3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.~Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects"
11344477|NCT04218110|OG000|Outcome|Project X 26ml|"3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344478|NCT04218110|OG001|Outcome|Project X 10.5ml|"3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344479|NCT04218110|OG002|Outcome|Project X 5.1ml|"3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344480|NCT04218110|OG003|Outcome|Prevantics Maxi Swabstick|"3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.~Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects"
11344481|NCT04218110|EG000|Reported Event|Project X 26ml|"3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344482|NCT04218110|EG001|Reported Event|Project X 10.5ml|"3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
11344483|NCT04218110|EG002|Reported Event|Project X 5.1ml|"3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.~Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects"
10855206|NCT00327470|BG001|Baseline|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
10855207|NCT00327470|BG002|Baseline|Total|Total of all reporting groups
10976527|NCT00940992|FG001|Participant Flow|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
11344484|NCT04218110|EG003|Reported Event|Prevantics Maxi Swabstick|"3.15% w/v CHG/70% v/v IPA contained within pre-saturated applicator. 5.1ml volume. Single use.~Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects"
11344485|NCT04222725|BG000|Baseline|TRS01 Low Dose|TRS01 eye drops: Dosed 4 times a day (QID)
11344486|NCT04222725|BG001|Baseline|TRS01 Medium Dose|TRS01 eye drops: Dosed QID
11344487|NCT04222725|BG002|Baseline|TRS01 High Dose|TRS01 eye drops: Dosed QID
11344488|NCT04222725|BG003|Baseline|Placebo|Placebo eye drops: Dosed QID
11344489|NCT04222725|BG004|Baseline|Total|Total of all reporting groups
11344490|NCT04222725|FG000|Participant Flow|TRS01 Low Dose|TRS01 eye drops: Dosed 4 times a day (QID)
11344491|NCT04222725|FG001|Participant Flow|TRS01 Medium Dose|TRS01 eye drops: Dosed QID
11344492|NCT04222725|FG002|Participant Flow|TRS01 High Dose|TRS01 eye drops: Dosed QID
11344493|NCT04222725|FG003|Participant Flow|Placebo|Placebo eye drops: Dosed QID
11344494|NCT04222725|OG000|Outcome|TRS01 Low Dose|TRS01 eye drops: Dosed 4 times a day (QID)
11344495|NCT04222725|OG001|Outcome|TRS01 Medium Dose|TRS01 eye drops: Dosed QID
11344496|NCT04222725|OG002|Outcome|TRS01 High Dose|TRS01 eye drops: Dosed QID
11344497|NCT04222725|OG003|Outcome|Placebo|Placebo eye drops: Dosed QID
11344498|NCT04222725|EG000|Reported Event|TRS01 Low Dose|TRS01 eye drops: Dosed 4 times a day (QID)
11344499|NCT04222725|EG001|Reported Event|TRS01 Medium Dose|TRS01 eye drops: Dosed QID
11344500|NCT04222725|EG002|Reported Event|TRS01 High Dose|TRS01 eye drops: Dosed QID
11344501|NCT04222725|EG003|Reported Event|Placebo|Placebo eye drops: Dosed QID
11344502|NCT04223843|BG000|Baseline|Tio+Olo (5μg/5μg) - Sub-optimal PIFR|A fixed dose combination of 5 microgram (μg)/5μg (two times 2.5µg/2.5µg) tiotropium + olodaterol (Tio+Olo) inhalation solution was administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (<60 Liter(L)/minute (min)) over a 4-week treatment period.
11344503|NCT04223843|BG001|Baseline|Matching Placebo - Sub-optimal PIFR|2 inhalation solutions of matching placebo were administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (<60 L/min) over a 4-week treatment period.
11344504|NCT04223843|BG002|Baseline|Tio+Olo (5μg/5μg ) - Optimal PIFR|A fixed dose combination of 5μg/5μg (two times 2.5µg/2.5µg) tiotropium + olodaterol (Tio+Olo) inhalation solution was administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (≥60 L/min) over a 4-week treatment period.
11344505|NCT04223843|BG003|Baseline|Matching Placebo - Optimal PIFR|2 inhalation solutions of matching placebo were administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with optimal peak inspiratory flow rate (PIFR) (≥60 L/min) over a 4-week treatment period.
11344506|NCT04223843|BG004|Baseline|Total|Total of all reporting groups
11344507|NCT04223843|FG000|Participant Flow|Tio+Olo (5μg/5μg) - Sub-optimal PIFR|A fixed dose combination of 5 microgram (μg)/5μg (two times 2.5µg/2.5µg) tiotropium + olodaterol (Tio+Olo) inhalation solution was administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (<60 Liter(L)/minute (min)) over a 4-week treatment period.
11344508|NCT04223843|FG001|Participant Flow|Matching Placebo - Sub-optimal PIFR|2 inhalation solutions of matching placebo were administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (<60 L/min) over a 4-week treatment period.
11344509|NCT04223843|FG002|Participant Flow|Tio+Olo (5μg/5μg ) - Optimal PIFR|A fixed dose combination of 5μg/5μg (two times 2.5µg/2.5µg) tiotropium + olodaterol (Tio+Olo) inhalation solution was administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (≥60 L/min) over a 4-week treatment period.
11344510|NCT04223843|FG003|Participant Flow|Matching Placebo - Optimal PIFR|2 inhalation solutions of matching placebo were administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with optimal peak inspiratory flow rate (PIFR) (≥60 L/min) over a 4-week treatment period.
11344511|NCT04223843|OG000|Outcome|Tio+Olo (5μg/5μg) - Sub-optimal PIFR|A fixed dose combination of 5 microgram (μg)/5μg (two times 2.5µg/2.5µg) tiotropium + olodaterol (Tio+Olo) inhalation solution was administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (<60 Liter(L)/minute (min)) over a 4-week treatment period.
11344512|NCT04223843|OG001|Outcome|Matching Placebo - Sub-optimal PIFR|2 inhalation solutions of matching placebo were administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (<60 L/min) over a 4-week treatment period.
11344513|NCT04223843|OG002|Outcome|Tio+Olo (5μg/5μg ) - Optimal PIFR|A fixed dose combination of 5μg/5μg (two times 2.5µg/2.5µg) tiotropium + olodaterol (Tio+Olo) inhalation solution was administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with sub-optimal peak inspiratory flow rate (PIFR) (≥60 L/min) over a 4-week treatment period.
11344514|NCT04223843|OG003|Outcome|Matching Placebo - Optimal PIFR|2 inhalation solutions of matching placebo were administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and with optimal peak inspiratory flow rate (PIFR) (≥60 L/min) over a 4-week treatment period.
11344515|NCT04223843|EG000|Reported Event|5μg/5μg Tio+Olo - Overall|A fixed dose combination (FDC) of 5μg/5μg (two times 2.5µg/2.5µg) tiotropium + olodaterol (Tio+Olo) inhalation solution was administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 4-week treatment period. Overall group included patients with both, sub-optimal (<60 L/min) peak inspiratory flow rate (PIFR) and optimal (≥60 L/min) peak inspiratory flow rate (PIFR).
11222901|NCT02349633|OG000|Outcome|PF-06747775 200 mg QD Group|Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
11222902|NCT02349633|OG000|Outcome|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222903|NCT02349633|OG001|Outcome|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222904|NCT02349633|OG007|Outcome|PF-06747775 200 mg QD Group|Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
11222905|NCT02349633|OG008|Outcome|Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD|Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
11222906|NCT02349633|OG009|Outcome|Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD|Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
11222907|NCT02349633|OG010|Outcome|Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin|Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
11222908|NCT02349633|OG011|Outcome|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222909|NCT02349633|OG012|Outcome|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222910|NCT02349633|OG013|Outcome|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11222911|NCT02349633|OG009|Outcome|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222912|NCT02349633|OG010|Outcome|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222913|NCT02349633|OG011|Outcome|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11222914|NCT02349633|OG007|Outcome|Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD|Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
11222915|NCT02349633|OG008|Outcome|Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin|Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
10855208|NCT00327470|FG000|Participant Flow|Early Age-related Macular Degeneration (AMD)|Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
11222916|NCT02349633|OG000|Outcome|Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD|Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
11222917|NCT02349633|OG001|Outcome|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222918|NCT02349633|OG002|Outcome|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222919|NCT02349633|OG003|Outcome|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11344516|NCT04223843|EG001|Reported Event|Matching Placebo - Overall|2 inhalation solutions of matching placebo were administered orally once daily via Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 4-week treatment period. Overall group included patients with both, sub-optimal (<60 L/min) peak inspiratory flow rate (PIFR) and optimal (≥60 L/min) peak inspiratory flow rate (PIFR).
11348500|NCT04157738|OG001|Outcome|Insulin to Carbohydrate Ratio (ICR) Group|"Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen~Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)~Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)"
10855209|NCT00327470|FG001|Participant Flow|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
10855210|NCT00327470|OG000|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
10855211|NCT00327470|OG001|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
10855212|NCT00327470|EG000|Reported Event|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
10855213|NCT00327470|EG001|Reported Event|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
10855214|NCT00327717|BG000|Baseline|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
10855215|NCT00327717|BG001|Baseline|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
10855216|NCT00327717|BG002|Baseline|Total|Total of all reporting groups
10855217|NCT00327717|FG000|Participant Flow|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
10855218|NCT00327717|FG001|Participant Flow|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
10855219|NCT00327717|OG000|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
10855220|NCT00327717|OG001|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
10855221|NCT00327717|EG000|Reported Event|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
10855222|NCT00327717|EG001|Reported Event|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
10855223|NCT00328016|BG000|Baseline|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period.
10976528|NCT00940992|FG002|Participant Flow|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
10976529|NCT00940992|OG000|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
11344517|NCT04229303|BG000|Baseline|Part 1 - ZP-059 5mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344518|NCT04229303|BG001|Baseline|Part 1 - ZP-059 10mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344519|NCT04229303|BG002|Baseline|Part 1 - ZP-059 20mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344520|NCT04229303|BG003|Baseline|Part 1 - ZP-059 40mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344521|NCT04229303|BG004|Baseline|Part 2 - ZP-059 10mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.~Cohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344522|NCT04229303|BG005|Baseline|Part 2 - ZP-059 20mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
10848846|NCT00291694|EG001|Reported Event|Placebo|Randomized to receive palcebo daily for 12 months
11344523|NCT04229303|BG006|Baseline|Part 2 - ZP-059 40mg qd|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) administered via DPI (RS01 monodose device) on Days 1 to 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344524|NCT04229303|BG007|Baseline|Part 3 - ZP-059 / Oral Voriconazole|"Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344525|NCT04229303|BG008|Baseline|Part 3 - Oral Voriconazole / ZP-059|"Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344526|NCT04229303|BG009|Baseline|Total|Total of all reporting groups
11344527|NCT04229303|FG000|Participant Flow|Part 1 - ZP-059 5mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344528|NCT04229303|FG001|Participant Flow|Part 1 - ZP-059 10mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11348501|NCT04157738|EG000|Reported Event|Fixed Group|"Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.~Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)~Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)"
10976530|NCT00940992|OG001|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
11344529|NCT04229303|FG002|Participant Flow|Part 1 - ZP-059 20mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344530|NCT04229303|FG003|Participant Flow|Part 1 - ZP-059 40mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344531|NCT04229303|FG004|Participant Flow|Part 2 - ZP-059 10mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.~Cohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344532|NCT04229303|FG005|Participant Flow|Part 2 - ZP-059 20mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344533|NCT04229303|FG006|Participant Flow|Part 2 - ZP-059 40mg qd|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11348502|NCT04157738|EG001|Reported Event|Insulin to Carbohydrate Ratio (ICR) Group|"Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen~Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)~Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)"
11348503|NCT04156646|BG000|Baseline|Treatment Sequence ABC|"Participants were randomized to ABC sequence on Day 1 of Period 1 with the treatments being as follows:~Treatment A: 20 mg balovaptan administered as a single oral dose following consumption of high-fat, high-calorie meal~Treatment B: 20 mg balovaptan administered as a single oral dose after a ≥10-hour fast~Treatment C: 40 mg esomeprazole administered once daily (QD) for 6 days and with a single dose of balovaptan 20 mg in the fasted state 1 hour after the fifth esomeprazole dose"
10976531|NCT00940992|OG002|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
11344534|NCT04229303|FG007|Participant Flow|Part 3 - ZP-059 / Oral Voriconazole|"Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344535|NCT04229303|FG008|Participant Flow|Part 3 - Oral Voriconazole / ZP-059|"Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344536|NCT04229303|OG000|Outcome|Part 1 - ZP-059 5mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344537|NCT04229303|OG001|Outcome|Part 1 - ZP-059 10mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344538|NCT04229303|OG002|Outcome|Part 1 - ZP-059 20mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11348504|NCT04156646|BG001|Baseline|Treatment Sequence BAC|"Participants were randomized to BAC sequence on Day 1 of Period 1 with the treatments being as follows:~Treatment B: 20 mg balovaptan administered as a single oral dose after a ≥10-hour fast~Treatment A: 20 mg balovaptan administered as a single oral dose following consumption of high-fat, high-calorie meal~Treatment C: 40 mg esomeprazole administered once daily (QD) for 6 days and with a single dose of balovaptan 20 mg in the fasted state 1 hour after the fifth esomeprazole dose"
11348505|NCT04156646|BG002|Baseline|Total|Total of all reporting groups
11344539|NCT04229303|OG003|Outcome|Part 1 - ZP-059 40mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344540|NCT04229303|OG004|Outcome|Part 2 - ZP-059 10mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.~Cohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344541|NCT04229303|OG005|Outcome|Part 2 - ZP-059 20mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344542|NCT04229303|OG006|Outcome|Part 2 - ZP-059 40mg qd|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344543|NCT04229303|OG007|Outcome|Part 3 - ZP-059 20mg|"Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11348506|NCT04156646|FG000|Participant Flow|Treatment Sequence ABC|"Participants were randomized to ABC sequence on Day 1 of Period 1 with the treatments being as follows:~Treatment A: 20 mg balovaptan administered as a single oral dose following consumption of high-fat, high-calorie meal~Treatment B: 20 mg balovaptan administered as a single oral dose after a ≥10-hour fast~Treatment C: 40 mg esomeprazole administered once daily (QD) for 6 days and with a single dose of balovaptan 20 mg in the fasted state 1 hour after the fifth esomeprazole dose"
10976532|NCT00940992|EG000|Reported Event|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
11344544|NCT04229303|OG008|Outcome|Part 3 - Oral Voriconazole 200mg|"Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344545|NCT04229303|OG000|Outcome|Part 2 - ZP-059 10mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.~Cohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344546|NCT04229303|OG001|Outcome|Part 2 - ZP-059 20mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344547|NCT04229303|OG002|Outcome|Part 2 - ZP-059 40mg qd|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344548|NCT04229303|OG000|Outcome|Part 3 - ZP-059|"Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11348507|NCT04156646|FG001|Participant Flow|Treatment Sequence BAC|"Participants were randomized to BAC sequence on Day 1 of Period 1 with the treatments being as follows:~Treatment B: 20 mg balovaptan administered as a single oral dose after a ≥10-hour fast~Treatment A: 20 mg balovaptan administered as a single oral dose following consumption of high-fat, high-calorie meal~Treatment C: 40 mg esomeprazole administered once daily (QD) for 6 days and with a single dose of balovaptan 20 mg in the fasted state 1 hour after the fifth esomeprazole dose"
11348508|NCT04156646|OG000|Outcome|Balovaptan 20 mg Fed|Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were administered following consumption of a high-fat, high-calorie meal (Treatment A).
10976533|NCT00940992|EG001|Reported Event|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
11344549|NCT04229303|OG001|Outcome|Part 3 - Oral Voriconazole|"Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344550|NCT04229303|OG000|Outcome|Part 1 - ZP-059 20mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344551|NCT04229303|OG002|Outcome|Part 3 - ZP-059|"Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344552|NCT04229303|OG003|Outcome|Part 3 - Oral Voriconazole|"Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344553|NCT04229303|EG000|Reported Event|Part 1 - ZP-059 5mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
10976534|NCT00940992|EG002|Reported Event|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
11007025|NCT01089062|OG000|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose 2 hours from time of first dose.
11344554|NCT04229303|EG001|Reported Event|Part 1 - ZP-059 10mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344555|NCT04229303|EG002|Reported Event|Part 1 - ZP-059 20mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344556|NCT04229303|EG003|Reported Event|Part 1 - ZP-059 40mg|"Part 1: administration of single ascending doses (SAD) of ZP-059.~Cohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344557|NCT04229303|EG004|Reported Event|Part 2 - ZP-059 10mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.~Cohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344558|NCT04229303|EG005|Reported Event|Part 2 - ZP-059 20mg Bid|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11344559|NCT04229303|EG006|Reported Event|Part 2 - ZP-059 40mg qd|"Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.~Cohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler)."
11348509|NCT04156646|OG001|Outcome|Balovaptan 20 mg Fasted|Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were after a ≥ 10 h fast (Treatment B)
11344560|NCT04229303|EG007|Reported Event|Part 3 - ZP-059|"Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344561|NCT04229303|EG008|Reported Event|Part 3 - Oral Voriconazole|"Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.~Voriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.~Part 2 (MAD): eligible subjects received 2 (10mg twice daily [BID]) or 4 [20mg BID]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily [QD]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.~Part 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.~ZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).~oral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study."
11344562|NCT04243421|BG000|Baseline|Group With Implants|"Flap will be elevated following the crestal and releasing incisions (if necessary).~After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height.~If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below.~Implantation: Soft tissue aesthetics, marginal bone level on CBCT"
11344563|NCT04243421|FG000|Participant Flow|Group With Implants|"Flap will be elevated following the crestal and releasing incisions (if necessary).~After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height.~If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below.~Implantation: Soft tissue aesthetics, marginal bone level on Cone Beam Computed Tomography (CBCT)."
11344564|NCT04243421|OG000|Outcome|Group With Implants|"Flap will be elevated following the crestal and releasing incisions (if necessary).~After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height.~If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below.~Implantation: Soft tissue aesthetics, marginal bone level on CBCT"
11344565|NCT04243421|OG000|Outcome|Group With Implants|"Flap will be elevated following the crestal and releasing incisions (if necessary).~After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height.~If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below.~Implantation: Soft tissue aesthetics, marginal bone level on Cone Beam Computed Tomography (CBCT)."
11348510|NCT04156646|OG002|Outcome|Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted|Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were coadministered with esomeprazole 40 mg (Treatment C) in a fasted state
11348511|NCT04156646|OG000|Outcome|Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted|Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were coadministered with esomeprazole 40 mg (Treatment C) in a fasted state
10848847|NCT00291876|BG000|Baseline|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
10976535|NCT00941005|BG000|Baseline|Electroacustimulation|"Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.~Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects."
10976536|NCT00941005|BG001|Baseline|Control|"Sham electroacustimulation device (turned off)~Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery"
10976537|NCT00941005|BG002|Baseline|Total|Total of all reporting groups
10976538|NCT00941005|FG000|Participant Flow|Electroacustimulation|"Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.~Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects."
10976539|NCT00941005|FG001|Participant Flow|Control|"Sham electroacustimulation device (turned off)~Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery"
10976540|NCT00941005|OG000|Outcome|Electroacustimulation|"Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.~Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects."
10976541|NCT00941005|OG001|Outcome|Control|"Sham electroacustimulation device (turned off)~Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery"
10976542|NCT00941005|OG000|Outcome|Electroacustimulation|"Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.~Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects."
10976543|NCT00941005|OG001|Outcome|Control|"Received a device that was not turned on.~Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects."
10976544|NCT00941005|EG000|Reported Event|Electroacustimulation|"Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.~Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects."
10976545|NCT00941005|EG001|Reported Event|Control|"Sham electroacustimulation device (turned off)~Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery"
10976546|NCT00941031|BG000|Baseline|Induction Single Dose|Baseline through Week 12
10976547|NCT00941031|BG001|Baseline|Induction Monthly Dose|
10976548|NCT00941031|BG002|Baseline|Induction Early Loading Dose|
10976549|NCT00941031|BG003|Baseline|Placebo|
10976550|NCT00941031|BG004|Baseline|Total|Total of all reporting groups
10976551|NCT00941031|FG000|Participant Flow|Induction Single Dose|"Induction with single injection - Single: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12"
10976552|NCT00941031|FG001|Participant Flow|Induction Monthly Dose|"Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12"
10976553|NCT00941031|FG002|Participant Flow|Induction Early Loading|"Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12"
10976554|NCT00941031|FG003|Participant Flow|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
10976555|NCT00941031|FG004|Participant Flow|Fixed Interval|"Fixed-time interval regimen - FI: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
10976556|NCT00941031|FG005|Participant Flow|Start of Relapse|"Treatment at start of relapse regimen - SR: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
10976557|NCT00941031|FG006|Participant Flow|Open Label|"Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - OL: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29"
10976558|NCT00941031|OG000|Outcome|Induction Single Dose|"Induction with single injection - Single: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12"
10976559|NCT00941031|OG001|Outcome|Induction Monthly Dose|"Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12"
10976560|NCT00941031|OG002|Outcome|Induction Early Loading Dose|"Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12"
10976561|NCT00941031|OG003|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
10976562|NCT00941031|OG000|Outcome|Maintenance Fixed Interval|"Fixed-time interval regimen - FI: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
10976563|NCT00941031|OG001|Outcome|Maintenance Start of Relapse|"Treatment at start of relapse regimen - SR: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
10976564|NCT00941031|OG002|Outcome|Maintenance Open Label|"Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - OL: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29"
11344566|NCT04243421|EG000|Reported Event|Group With Implants|"Flap will be elevated following the crestal and releasing incisions (if necessary).~After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height.~If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below.~Implantation: Soft tissue aesthetics, marginal bone level on CBCT"
11344567|NCT04256603|BG000|Baseline|Gabapentin|"Gabapentin prior to admission~Gabapentin: Timing of gabapentin initiation"
11344568|NCT04256603|BG001|Baseline|No Gabapentin|"Gabapentin during admission~Gabapentin: Timing of gabapentin initiation"
11344569|NCT04256603|BG002|Baseline|Total|Total of all reporting groups
11344570|NCT04256603|FG000|Participant Flow|Gabapentin Group|The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records.
11344571|NCT04256603|FG001|Participant Flow|No Gabapentin Group|The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care.
11344572|NCT04256603|OG000|Outcome|Gabapentin Group|The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records.
11344573|NCT04256603|OG001|Outcome|No Gabapentin Group|The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care.
11344574|NCT04256603|EG000|Reported Event|Gabapentin Group|The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records.
11344575|NCT04256603|EG001|Reported Event|No Gabapentin Group|The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care.
11344576|NCT04258995|BG000|Baseline|GBS6 20 μg With AlPO4|Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.
11344577|NCT04258995|BG001|Baseline|GBS6 20 μg Without AlPO4|Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.
11344578|NCT04258995|BG002|Baseline|Total|Total of all reporting groups
11344579|NCT04258995|FG000|Participant Flow|GBS6 20 μg With AlPO4|Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.
11344580|NCT04258995|FG001|Participant Flow|GBS6 20 μg Without AlPO4|Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.
11344581|NCT04258995|OG000|Outcome|GBS6 20 μg With AlPO4|Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.
11344582|NCT04258995|OG001|Outcome|GBS6 20 μg Without AlPO4|Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.
11344583|NCT04258995|EG000|Reported Event|GBS6 20 μg With AlPO4|Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.
11344584|NCT04258995|EG001|Reported Event|GBS6 20 μg Without AlPO4|Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.
11344585|NCT04280445|BG000|Baseline|Psychological Therapy|"All participants will receive psychological therapy. There will be no placebos or waiting list controlled participants to compare findings to.~Psychological therapy: Acceptance and Commitment Therapy (ACT) is a trans-diagnostic approach which aims to promote better living by supporting clients through six key processes (e.g. mindfulness, values). ACT does not aim to reduce distress, rather its goal is to promote better living or a better quality of life despite distress (Hayes, Strosahl & Wilson, 1999). ACT has been shown to have equal or superior efficacy to CBT with a number of psychological and physical health conditions (A-Tjak et al., 2015; Ruiz, 2012)."
11344586|NCT04280445|FG000|Participant Flow|Psychological Therapy|"All participants will receive psychological therapy. There will be no placebos or waiting list controlled participants to compare findings to.~Psychological therapy: Acceptance and Commitment Therapy (ACT) is a trans-diagnostic approach which aims to promote better living by supporting clients through six key processes (e.g. mindfulness, values). ACT does not aim to reduce distress, rather its goal is to promote better living or a better quality of life despite distress (Hayes, Strosahl & Wilson, 1999). ACT has been shown to have equal or superior efficacy to CBT with a number of psychological and physical health conditions (A-Tjak et al., 2015; Ruiz, 2012)."
11344587|NCT04280445|OG000|Outcome|Psychological Therapy|"All participants will receive psychological therapy. There will be no placebos or waiting list controlled participants to compare findings to.~Psychological therapy: Acceptance and Commitment Therapy (ACT) is a trans-diagnostic approach which aims to promote better living by supporting clients through six key processes (e.g. mindfulness, values). ACT does not aim to reduce distress, rather its goal is to promote better living or a better quality of life despite distress (Hayes, Strosahl & Wilson, 1999). ACT has been shown to have equal or superior efficacy to CBT with a number of psychological and physical health conditions (A-Tjak et al., 2015; Ruiz, 2012)."
11344588|NCT04280445|EG000|Reported Event|Psychological Therapy|"All participants will receive psychological therapy. There will be no placebos or waiting list controlled participants to compare findings to.~Psychological therapy: Acceptance and Commitment Therapy (ACT) is a trans-diagnostic approach which aims to promote better living by supporting clients through six key processes (e.g. mindfulness, values). ACT does not aim to reduce distress, rather its goal is to promote better living or a better quality of life despite distress (Hayes, Strosahl & Wilson, 1999). ACT has been shown to have equal or superior efficacy to CBT with a number of psychological and physical health conditions (A-Tjak et al., 2015; Ruiz, 2012)."
11344589|NCT04285489|BG000|Baseline|HAKIM Programmable Shunt System Arm|One year' safety data of patients implanted HAKIM Programmable Shunt system from April 01, 2017 to August 31, 2019.
11344590|NCT04285489|FG000|Participant Flow|HAKIM Programmable Shunt System Arm|130 patients would be enrolled and adverse events would be collected for subjects enrolled within one year after the implantation of HAKIM Programmable Shunt system from April 01, 2017 to August 31, 2019, through case review or hospital database.
11344591|NCT04285489|OG000|Outcome|Treatment Arm, Single Arm Study|This study was designed to be single arm, multi-center, observational and retrospective. It is designed to collect information from actual clinical practice from the clinical records of patients in relation to the one-year clinical safety to the use of operation of HAKIM Programmable Shunt system.
11344592|NCT04285489|EG000|Reported Event|HAKIM Programmable Shunt System Arm|Subject implanted HAKIM Programmable Shunt system for at least of one-year.
11344593|NCT04290494|BG000|Baseline|China National Stroke Registry (CNSR) I (2007 to 2008)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.
11344594|NCT04290494|BG001|Baseline|China National Stroke Registry (CNSR) II (2012 to 2013)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.
11344595|NCT04290494|BG002|Baseline|China National Stroke Registry (CNSR) III (2015 to 2017)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.
11344596|NCT04290494|BG003|Baseline|Total|Total of all reporting groups
11344597|NCT04290494|FG000|Participant Flow|China National Stroke Registry (CNSR) I (2007 to 2008)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.
11344598|NCT04290494|FG001|Participant Flow|China National Stroke Registry (CNSR) II (2012 to 2013)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.
11344599|NCT04290494|FG002|Participant Flow|China National Stroke Registry (CNSR) III (2015 to 2017)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.
11344600|NCT04290494|OG000|Outcome|China National Stroke Registry (CNSR) I (2007 to 2008)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.
11344601|NCT04290494|OG001|Outcome|China National Stroke Registry (CNSR) II (2012 to 2013)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.
11344602|NCT04290494|OG002|Outcome|China National Stroke Registry (CNSR) III (2015 to 2017)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.
11344603|NCT04290494|EG000|Reported Event|China National Stroke Registry (CNSR) I (2007 to 2008)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.
11344604|NCT04290494|EG001|Reported Event|China National Stroke Registry (CNSR) II (2012 to 2013)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.
11344605|NCT04290494|EG002|Reported Event|China National Stroke Registry (CNSR) III (2015 to 2017)|All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.
11344606|NCT04303156|BG000|Baseline|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 60 mg Islatravir administered in capsule form.
11344607|NCT04303156|BG001|Baseline|Healthy|Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form.
11344608|NCT04303156|BG002|Baseline|Total|Total of all reporting groups
11344609|NCT04303156|FG000|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 60 mg Islatravir administered in capsule form.
11344610|NCT04303156|FG001|Participant Flow|Healthy|Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form.
11344611|NCT04303156|OG000|Outcome|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 60 mg Islatravir administered in capsule form
11344612|NCT04303156|OG001|Outcome|Healthy|Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form.
11344613|NCT04303156|OG000|Outcome|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 60 mg Islatravir administered in capsule form.
11344614|NCT04303156|EG000|Reported Event|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 60 mg Islatravir administered in capsule form.
11344615|NCT04303156|EG001|Reported Event|Healthy|Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form.
11344616|NCT04317040|BG000|Baseline|CD24Fc|Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
11344617|NCT04317040|BG001|Baseline|Placebo|Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
11344618|NCT04317040|BG002|Baseline|Total|Total of all reporting groups
11344619|NCT04317040|FG000|Participant Flow|CD24Fc|Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
11344620|NCT04317040|FG001|Participant Flow|Placebo|Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
11344621|NCT04317040|OG000|Outcome|CD24Fc|Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
10848848|NCT00291876|FG000|Participant Flow|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
10976565|NCT00941031|EG000|Reported Event|INDUCTION: Single|INDUCTION: Early loading induction - 'Early'
11344622|NCT04317040|OG001|Outcome|Placebo|Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
11344623|NCT04317040|EG000|Reported Event|CD24Fc|Participants received single dose of CD24Fc 480 mg, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
11344624|NCT04317040|EG001|Reported Event|Placebo|Participants received single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes on Day 1.
11344625|NCT04317313|BG000|Baseline|Training Cohort|Patients diagnosed between July 2013 and March 2017
11344626|NCT04317313|BG001|Baseline|Validation Cohort|Patients diagnosed between April 2017 and July 2019
11344627|NCT04317313|BG002|Baseline|Total|Total of all reporting groups
11344628|NCT04317313|FG000|Participant Flow|Training Cohort|Patients diagnosed between July 2013 and March 2017. All patients underwent pre-treatment 18F-FDG PET/CT. PET/CT images were acquired on a Biograph mCT scanner (Siemens Healthcare, Germany) 60-70 min after intravenous injection of 18F-FDG (3.7 MBq/kg).
11344629|NCT04317313|FG001|Participant Flow|Validation Cohort|Patients diagnosed between April 2017 and July 2019. All patients underwent pre-treatment 18F-FDG PET/CT. PET/CT images were acquired on a Biograph mCT scanner (Siemens Healthcare, Germany) 60-70 min after intravenous injection of 18F-FDG (3.7 MBq/kg).
11344630|NCT04317313|OG000|Outcome|Training Cohort|Patients diagnosed between July 2013 and March 2017
11344631|NCT04317313|OG001|Outcome|Validation Cohort|Patients diagnosed between April 2017 and July 2019
11344632|NCT04317313|EG000|Reported Event|Training Cohort|Patients diagnosed between July 2013 and March 2017
11344633|NCT04317313|EG001|Reported Event|Validation Cohort|Patients diagnosed between April 2017 and July 2019
11344634|NCT04319159|BG000|Baseline|Stratum: Face/Scalp|• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
11344635|NCT04319159|BG001|Baseline|Stratum: Periphery|• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
11344636|NCT04319159|BG002|Baseline|Total|Total of all reporting groups
11348512|NCT04156646|EG000|Reported Event|Balovaptan 20 mg Fed|Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were administered following consumption of a high-fat, high-calorie meal (Treatment A).
11348513|NCT04156646|EG001|Reported Event|Balovaptan 20 mg Fasted|Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were after a ≥ 10 h fast (Treatment B)
11344637|NCT04319159|FG000|Participant Flow|BF-200 ALA (Stratum Face/Scalp and Stratum Periphery)|• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
11344638|NCT04319159|OG000|Outcome|Stratum: Face/Scalp|• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
11344639|NCT04319159|OG001|Outcome|Stratum: Periphery|• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
11344640|NCT04319159|EG000|Reported Event|Stratum: Face/Scalp|• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
11344641|NCT04319159|EG001|Reported Event|Stratum: Periphery|• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
11344642|NCT04321239|BG000|Baseline|Intervention Group|"Participants will engage in a 7-week positive psychology-based chronic pain self-management program.~Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker."
11344643|NCT04321239|BG001|Baseline|Usual Care Control Group|After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
11344644|NCT04321239|BG002|Baseline|Total|Total of all reporting groups
11348514|NCT04156646|EG002|Reported Event|Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted|Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were coadministered with esomeprazole 40 mg (Treatment C) in a fasted state.
11348515|NCT04170686|BG000|Baseline|Immediate Treatment|"Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.~Zemedy App for IBS: The Zemedy App for IBS is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS."
11344645|NCT04321239|FG000|Participant Flow|Intervention Group|"Participants will engage in a 7-week positive psychology-based chronic pain self-management program.~Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker."
11344646|NCT04321239|FG001|Participant Flow|Usual Care Control Group|After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
11344647|NCT04321239|OG000|Outcome|Intervention Group|"Participants will engage in a 7-week positive psychology-based chronic pain self-management program.~Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker."
11344648|NCT04321239|OG001|Outcome|Usual Care Control Group|After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
11344649|NCT04321239|EG000|Reported Event|Intervention Group|"Participants will engage in a 7-week positive psychology-based chronic pain self-management program.~Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker."
11344650|NCT04321239|EG001|Reported Event|Usual Care Control Group|After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
11344651|NCT04323852|BG000|Baseline|Vitamin D|"35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units~Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery"
11344652|NCT04323852|BG001|Baseline|Control Group|"35 patients that will receive placebo for 3 days and each day for 3 doses~Placebo: Placebo"
11344653|NCT04323852|BG002|Baseline|Total|Total of all reporting groups
11344654|NCT04323852|FG000|Participant Flow|Vitamin D|"35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units~Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery"
11344655|NCT04323852|FG001|Participant Flow|Control Group|"35 patients that will receive placebo for 3 days and each day for 3 doses~Placebo: Placebo"
11344656|NCT04323852|OG000|Outcome|Vitamin D|"35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units~Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery"
11344657|NCT04323852|OG001|Outcome|Control Group|"35 patients that will receive placebo for 3 days and each day for 3 doses~Placebo: Placebo"
11344658|NCT04323852|EG000|Reported Event|Vitamin D|"35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units~Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery"
11344659|NCT04323852|EG001|Reported Event|Control Group|"35 patients that will receive placebo for 3 days and each day for 3 doses~Placebo: Placebo"
11344660|NCT04327843|BG000|Baseline|CAE + LAI Treatment|The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
11344661|NCT04327843|FG000|Participant Flow|CAE + LAI Treatment|The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
11344662|NCT04327843|OG000|Outcome|CAE + LAI Treatment|The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
11344663|NCT04327843|EG000|Reported Event|CAE + LAI Treatment|The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
11348516|NCT04170686|BG001|Baseline|Waitlist Control|"Participants in the waitlist will receive no intervention for 8 weeks, other than a few check in emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app."
11348517|NCT04170686|BG002|Baseline|Total|Total of all reporting groups
11348518|NCT04170686|FG000|Participant Flow|Immediate Treatment|"Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.~Zemedy App for IBS: The Zemedy App for IBS is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS."
11348519|NCT04170686|FG001|Participant Flow|Waitlist Control|"Participants in the waitlist will receive no intervention for 8 weeks, other than a few check in emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app."
11348520|NCT04170686|OG000|Outcome|Immediate Treatment|"Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.~Zemedy App for IBS: The Zemedy App for IBS is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS."
11348521|NCT04170686|OG001|Outcome|Waitlist Control|"Participants in the waitlist will receive no intervention for 8 weeks, other than a few check in emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app."
11348522|NCT04170686|EG000|Reported Event|Immediate Treatment|"Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.~Zemedy App for IBS: The Zemedy App for IBS is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS."
11348523|NCT04170686|EG001|Reported Event|Waitlist Control|"Participants in the waitlist will receive no intervention for 8 weeks, other than a few check in emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app."
11348524|NCT04169113|BG000|Baseline|Group 1 - Hip Arthroscopy|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11348525|NCT04169113|BG001|Baseline|Group 2 - Hip Arthroscopy|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11348526|NCT04169113|BG002|Baseline|Total|Total of all reporting groups
10855224|NCT00328016|BG001|Baseline|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery period.
11348527|NCT04169113|FG000|Participant Flow|Group 1 (60) - Hip Arthroscopy|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11348528|NCT04169113|FG001|Participant Flow|Group 2 (30) - Hip Arthroscopy|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11348529|NCT04169113|OG000|Outcome|Group 1 (60) - Hip Arthroscopy|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11348530|NCT04169113|OG001|Outcome|Group 2 (30) - Hip Arthroscopy|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11348531|NCT04169113|EG000|Reported Event|Group 1 (60) - Hip Arthroscopy|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11348532|NCT04169113|EG001|Reported Event|Group 2 (30) - Hip Arthroscopy|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11348533|NCT04160975|BG000|Baseline|Black Participant-Concordant Sender-Expert Sender-Standard Signal|Black participants who are assigned to a concordant-exper sender delivering a standard signal.
11348534|NCT04160975|BG001|Baseline|Black Participant-Concordant Sender-Lay Sender-Standard Signal|Black participants who are assigned to a concordant-lay sender delivering a standard signal.
10855225|NCT00328016|BG002|Baseline|Total|Total of all reporting groups
10976566|NCT00941031|EG001|Reported Event|INDUCTION: Monthly|INDUCTION: with monthly injections - 'Monthly'
11344664|NCT04331899|BG000|Baseline|Lambda|Lambda single dose administered subcutaneously in addition to standard of care treatment.
11344665|NCT04331899|BG001|Baseline|Placebo|Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
11344666|NCT04331899|BG002|Baseline|Total|Total of all reporting groups
11344667|NCT04331899|FG000|Participant Flow|Lambda|Peginterferon Lambda-1a (Lambda) single dose administered subcutaneously in addition to standard of care treatment.
11344668|NCT04331899|FG001|Participant Flow|Placebo|Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
11344669|NCT04331899|OG000|Outcome|Lambda|Lambda single dose administered subcutaneously in addition to standard of care treatment.
11344670|NCT04331899|OG001|Outcome|Placebo|Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
11344671|NCT04331899|EG000|Reported Event|Lambda|Lambda single dose administered subcutaneously in addition to standard of care treatment.
11344672|NCT04331899|EG001|Reported Event|Placebo|Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
11344673|NCT04334148|BG000|Baseline|Hydroxychloroquine|"Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.~Hydroxychloroquine: oral self administered tablet"
11344674|NCT04334148|BG001|Baseline|Placebo|"Matching placebo tablets~Placebo oral tablet: oral self administered tablet"
11344675|NCT04334148|BG002|Baseline|Total|Total of all reporting groups
11344676|NCT04334148|FG000|Participant Flow|Hydroxychloroquine|"Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.~Hydroxychloroquine: oral self administered tablet"
11344677|NCT04334148|FG001|Participant Flow|Placebo|"Matching placebo tablets~Placebo oral tablet: oral self administered tablet"
11344678|NCT04334148|OG000|Outcome|Hydroxychloroquine|"Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.~Hydroxychloroquine: oral self administered tablet"
11344679|NCT04334148|OG001|Outcome|Placebo|"Matching placebo tablets~Placebo oral tablet: oral self administered tablet"
11344680|NCT04334148|EG000|Reported Event|Hydroxychloroquine|"Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.~Hydroxychloroquine: oral self administered tablet"
11344681|NCT04334148|EG001|Reported Event|Placebo|"Matching placebo tablets~Placebo oral tablet: oral self administered tablet"
11344682|NCT04343287|BG000|Baseline|BRM421 Ophthalmic Solution|"A topical solution of BRIM421 ophthalmic drops~BRM421: The active control with BRM421 solution"
11344683|NCT04343287|BG001|Baseline|Placebo|"A vehicle ophthalmic drops~Placebo: The vehicle solution"
11344684|NCT04343287|BG002|Baseline|Total|Total of all reporting groups
11344685|NCT04343287|FG000|Participant Flow|BRM421 Ophthalmic Solution|"A topical solution of BRIM421 ophthalmic drops~BRM421: The active control with BRM421 solution"
11344686|NCT04343287|FG001|Participant Flow|Placebo|"A vehicle ophthalmic drops~Placebo: The vehicle solution"
10976567|NCT00941031|EG002|Reported Event|INDUCTION: Early|INDUCTION: with single injection - 'Single'
11344687|NCT04343287|OG000|Outcome|BRM421 Ophthalmic Solution|"A topical solution of BRIM421 ophthalmic drops~BRM421: The active control with BRM421 solution"
11344688|NCT04343287|OG001|Outcome|Placebo|"A vehicle ophthalmic drops~Placebo: The vehicle solution"
10976568|NCT00941031|EG003|Reported Event|INDUCTION: Placebo|INDUCTION: Placebo - 'Placebo'
11344689|NCT04343287|OG000|Outcome|BRM421|"The active control with BRM421 solution~BRM421: A topical solution of BRIM421 ophthalmic drops"
11344690|NCT04343287|OG001|Outcome|Placebo|The vehicle solution
11344691|NCT04343287|EG000|Reported Event|BRM421 Ophthalmic Solution|"A topical solution of BRIM421 ophthalmic drops~BRM421: The active control with BRM421 solution"
11344692|NCT04343287|EG001|Reported Event|Placebo|"A vehicle ophthalmic drops~Placebo: The vehicle solution"
11344693|NCT04347954|BG000|Baseline|Isotonic Saline 0.9%|Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days.
11344694|NCT04347954|BG001|Baseline|Povidone-Iodine 0.5%|Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
11344695|NCT04347954|BG002|Baseline|Povidone-Iodine 2%|Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
11344696|NCT04347954|BG003|Baseline|Total|Total of all reporting groups
11344697|NCT04347954|FG000|Participant Flow|Isotonic Saline 0.9%|Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days.
11344698|NCT04347954|FG001|Participant Flow|Povidone-Iodine 0.5%|Participants administer 2 sprays of povidone-iodine (PVP-I) 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
11344699|NCT04347954|FG002|Participant Flow|Povidone-Iodine 2%|Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
11344700|NCT04347954|OG000|Outcome|Isotonic Saline 0.9%|Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days.
11344701|NCT04347954|OG001|Outcome|Povidone-Iodine 0.5%|Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
11344702|NCT04347954|OG002|Outcome|Povidone-Iodine 2%|Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
11344703|NCT04347954|EG000|Reported Event|Isotonic Saline 0.9%|Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days.
11344704|NCT04347954|EG001|Reported Event|Povidone-Iodine 0.5%|Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
11344705|NCT04347954|EG002|Reported Event|Povidone-Iodine 2%|Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
11344706|NCT04349098|BG000|Baseline|Selinexor 20 mg|Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
10976569|NCT00941031|EG004|Reported Event|MAINTENANCE: Fixed Interval|MAINTENANCE: Fixed-time interval regimen - 'FI'
11344707|NCT04349098|BG001|Baseline|Placebo|Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
11344708|NCT04349098|BG002|Baseline|Total|Total of all reporting groups
11344709|NCT04349098|FG000|Participant Flow|Selinexor 20 mg|Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
11344710|NCT04349098|FG001|Participant Flow|Placebo|Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
11344711|NCT04349098|OG000|Outcome|Selinexor 20 mg|Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
11344712|NCT04349098|OG001|Outcome|Placebo|Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
11344713|NCT04349098|EG000|Reported Event|Selinexor 20 mg|Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
11344714|NCT04349098|EG001|Reported Event|Placebo|Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
11344715|NCT04353037|BG000|Baseline|Substudy 1 Group 1 (HCQ)|COVID-19 positive PCR patients aged 50-75 in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.
11344716|NCT04353037|BG001|Baseline|Substudy 1 Group 2 (Placebo)|COVID-19 positive PCR patients aged 50-75 in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
11344717|NCT04353037|BG002|Baseline|Substudy 2 Group 1 (HCQ)|"Currently employed as a health care worker aged 18 or older. Must be asymptomatic and presumed negative for COVID-19.~Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months."
11344718|NCT04353037|BG003|Baseline|Substudy 2 Group 2 (Placebo)|"Currently employed as a health care worker aged 18 or older. Must be asymptomatic and presumed negative for COVID-19.~Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months."
11344719|NCT04353037|BG004|Baseline|Total|Total of all reporting groups
11344720|NCT04353037|FG000|Participant Flow|Sub Study 1 Group 1 (HCQ)|COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.
11344721|NCT04353037|FG001|Participant Flow|Sub Study 1 Group 2 (Placebo)|COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
11344722|NCT04353037|FG002|Participant Flow|Sub Study 2 Group 1 (HCQ)|Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg qd (three 200 mg tablets taken once a day) for 2 months.
11344723|NCT04353037|FG003|Participant Flow|Sub Study 2 Group 2 (Placebo)|Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
11344724|NCT04353037|OG000|Outcome|Sub Study 1 Group 1 (HCQ)|COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.
11344725|NCT04353037|OG001|Outcome|Sub Study 1 Group 2 (Placebo)|COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
11344726|NCT04353037|OG000|Outcome|Sub Study 2 Group 1 (HCQ)|Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months.
11344727|NCT04353037|OG001|Outcome|Sub Study 2 Group 2 (Placebo)|"Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19.~Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months."
11344728|NCT04353037|OG001|Outcome|Sub Study 2 Group 2 (Placebo)|Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
11344729|NCT04353037|OG000|Outcome|Sub Study 2 Group 1 (HCQ)|"Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19.~Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months."
10848849|NCT00291876|OG000|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
11344730|NCT04353037|EG000|Reported Event|Sub Study 1 Group 1 (HCQ)|COVID-19+ PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg bid for 14 days.
11344731|NCT04353037|EG001|Reported Event|Sub Study 1 Group 2 (Placebo)|COVID-19+ PCR patients in self-quarantine randomized to this arm will be treated with Place 2 pills bid for 14 days.
11344732|NCT04353037|EG002|Reported Event|Sub Study 2 Group 1 (HCQ)|"Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19.~Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months."
11344733|NCT04353037|EG003|Reported Event|Sub Study 2 Group 2 (Placebo)|"Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19.~Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months."
11344734|NCT04355117|BG000|Baseline|Treatment: TEV-48125|Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly for a total of 2 doses. The first dose was self-administered at the trial site under the supervision of the investigator (Baseline) and the second dose was self-administered at home (Visit 3).
11344735|NCT04355117|FG000|Participant Flow|Treatment: TEV-48125|Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly for a total of 2 doses. The first dose was self-administered at the trial site under the supervision of the investigator (Baseline) and the second dose was self-administered at home (Visit 3).
11344736|NCT04355117|OG000|Outcome|Self-administration at Trial Site|Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at the trial site under the supervision of the investigator (Baseline).
11344737|NCT04355117|OG001|Outcome|Self-administration at Home|Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at home (Visit 3).
11344738|NCT04355117|OG000|Outcome|Treatment: TEV-48125|Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly for a total of 2 doses. The first dose was self-administered at the trial site under the supervision of the investigator (Baseline) and the second dose was self-administered at home (Visit 3).
11344739|NCT04355117|EG000|Reported Event|Treatment: TEV-48125|Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly for a total of 2 doses. The first dose was self-administered at the trial site under the supervision of the investigator (Baseline) and the second dose was self-administered at home (Visit 3).
11344740|NCT04355767|BG000|Baseline|Convalescent Plasma|Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
11344741|NCT04355767|BG001|Baseline|Placebo|Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
11344742|NCT04355767|BG002|Baseline|Total|Total of all reporting groups
11344743|NCT04355767|FG000|Participant Flow|Convalescent Plasma|Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
10976570|NCT00941031|EG005|Reported Event|MAINTENANCE: Start of Relapse|MAINTENANCE: Treatment at start of relapse regimen - 'SR'
11344744|NCT04355767|FG001|Participant Flow|Placebo|Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
11344745|NCT04355767|OG000|Outcome|Convalescent Plasma|Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
11344746|NCT04355767|OG001|Outcome|Placebo|Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
11344747|NCT04355767|EG000|Reported Event|Convalescent Plasma|Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
11344748|NCT04355767|EG001|Reported Event|Placebo|Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
11344749|NCT04356573|BG000|Baseline|Gold Kiwifruit First, Then Green Hayward Kiwifruit|Subjects were first asked to eat 2 gold kiwifruit with midday meal for 14 days prior to testing. Then a washout for 14 days. Then, subjects were asked to eat 2 green Hayward kiwifruit with midday meal for 2 weeks prior to a second set of testing.
11344750|NCT04356573|BG001|Baseline|Green Hayward Kiwifruit First, Then Gold Kiwifruit|Subjects were first asked to eat 2 green Hayward kiwifruit with midday meal for 2 weeks prior to testing. Then a washout for 14 days. Then, subjects were asked to eat 2 gold kiwifruit with midday meal for 2 weeks prior to a second set of testing.
11344751|NCT04356573|BG002|Baseline|Total|Total of all reporting groups
11344752|NCT04356573|FG000|Participant Flow|Gold Kiwifruit First, Then Green Hayward Kiwifruit|"Subjects were first asked to eat 2 gold kiwifruit with midday meal for 2 weeks prior to testing.~Later, subjects were asked to eat 2 green Hayward kiwifruit with midday meal for 2 weeks prior to a second set of testing."
11344753|NCT04356573|FG001|Participant Flow|Green Hayward Kiwifruit First, Then Gold Kiwifruit|"Subjects were first asked to eat 2 green Hayward kiwifruit with midday meal for 2 weeks prior to testing.~Later, subjects were asked to eat 2 gold kiwifruit with midday meal for 2 weeks prior to a second set of testing."
11344754|NCT04356573|OG000|Outcome|Gold Kiwifruit|"Subjects ate 2 gold kiwifruit with midday meal for 2 weeks.~fresh kiwifruit: Subjects ate 2 peeled kiwifruit with their midday meal for 2 weeks prior to testing."
11344755|NCT04356573|OG001|Outcome|Green Hayward Kiwifruit|"Subjects ate 2 green Hayward kiwifruit with midday meal for 2 weeks.~fresh kiwifruit: Subjects ate 2 peeled kiwifruit with their midday meal for 2 weeks prior to testing."
11344756|NCT04356573|EG000|Reported Event|Gold Kiwifruit|"Subjects ate 2 gold kiwifruit with midday meal for 2 weeks.~Half of the subjects ate the gold kiwifruit first, half of the subjects ate the gold kiwifruit second; however all subjects ate 2 gold kiwifruit with midday meal for 2 weeks at some point in this study."
11344757|NCT04356573|EG001|Reported Event|Green Hayward Kiwifruit|"Subjects ate 2 green Hayward kiwifruit with midday meal for 2 weeks.~Half of the subjects ate the green Hayward kiwifruit first, half of the subjects ate the green Hayward kiwifruits second; however all subjects ate 2 green Hayward kiwifruit with midday meal for 2 weeks at some point in this study."
11344758|NCT04357379|BG000|Baseline|IQOS Group|IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
11344759|NCT04357379|FG000|Participant Flow|IQOS Group|IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
11344760|NCT04357379|OG000|Outcome|IQOS Group|IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
11344761|NCT04357379|EG000|Reported Event|IQOS Group|IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
10848850|NCT00291876|EG000|Reported Event|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
11344762|NCT04358068|BG000|Baseline|Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)|"Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:~Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).~Hydroxychloroquine (HCQ): Administered orally~Azithromycin (Azithro): Administered orally"
11344763|NCT04358068|BG001|Baseline|Arm B: Placebo for Hydroxychloroquine and Azithromycin|"Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:~Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).~Placebo for Hydroxychloroquine: Administered orally~Placebo for Azithromycin: Administered orally"
11344764|NCT04358068|BG002|Baseline|Total|Total of all reporting groups
11344765|NCT04358068|FG000|Participant Flow|Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)|"Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:~Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).~Hydroxychloroquine (HCQ): Administered orally~Azithromycin (Azithro): Administered orally"
11344766|NCT04358068|FG001|Participant Flow|Arm B: Placebo for Hydroxychloroquine and Azithromycin|"Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:~Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).~Placebo for Hydroxychloroquine: Administered orally~Placebo for Azithromycin: Administered orally"
11344767|NCT04358068|OG000|Outcome|Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)|"Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:~Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).~Hydroxychloroquine (HCQ): Administered orally~Azithromycin (Azithro): Administered orally"
11344768|NCT04358068|OG001|Outcome|Arm B: Placebo for Hydroxychloroquine and Azithromycin|"Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:~Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).~Placebo for Hydroxychloroquine: Administered orally~Placebo for Azithromycin: Administered orally"
11344769|NCT04358068|EG000|Reported Event|Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)|"Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:~Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).~Hydroxychloroquine (HCQ): Administered orally~Azithromycin (Azithro): Administered orally"
11344770|NCT04358068|EG001|Reported Event|Arm B: Placebo for Hydroxychloroquine and Azithromycin|"Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:~Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).~Placebo for Hydroxychloroquine: Administered orally~Placebo for Azithromycin: Administered orally"
11344771|NCT04366349|BG000|Baseline|Cohorts 1 and 2: Placebo SC|Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.
11344772|NCT04366349|BG001|Baseline|Cohort 1: GSK3772847 70 mg SC|Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.
11344773|NCT04366349|BG002|Baseline|Cohort 2: GSK3772847 140 mg SC|Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.
11344774|NCT04366349|BG003|Baseline|Cohorts 3 and 4: Placebo SC|Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.
10976571|NCT00941031|EG006|Reported Event|MAINTENANCE: Open Label|"MAINTENANCE: Open label Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - OL: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks."
11344775|NCT04366349|BG004|Baseline|Cohort 3: GSK3772847 140 mg SC in Japanese Participants|Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.
11344776|NCT04366349|BG005|Baseline|Cohort 4: GSK3772847 140 mg SC in Chinese Participants|Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
11344777|NCT04366349|BG006|Baseline|Total|Total of all reporting groups
11344778|NCT04366349|FG000|Participant Flow|Cohorts 1 and 2: Placebo SC|Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.
11348535|NCT04160975|BG002|Baseline|Black Participant-Discordant Sender-Expert Sender-Standard Signal|Black participants who are assigned to a discordant-exper sender delivering a standard signal.
10976572|NCT00941031|EG007|Reported Event|FOLLOW-UP: Fixed Interval|FOLLOW-UP: Fixed-time interval regimen - 'FI'
11344779|NCT04366349|FG001|Participant Flow|Cohort 1: GSK3772847 70 mg SC|Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.
11344780|NCT04366349|FG002|Participant Flow|Cohort 2: GSK3772847 140 mg SC|Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.
11344781|NCT04366349|FG003|Participant Flow|Cohorts 3 and 4: Placebo SC|Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.
11344782|NCT04366349|FG004|Participant Flow|Cohort 3: GSK3772847 140 mg SC in Japanese Participants|Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.
11344783|NCT04366349|FG005|Participant Flow|Cohort 4: GSK3772847 140 mg SC in Chinese Participants|Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
11344784|NCT04366349|OG000|Outcome|Cohorts 1 and 2: Placebo SC|Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.
11344785|NCT04366349|OG001|Outcome|Cohort 1: GSK3772847 70 mg SC|Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.
11344786|NCT04366349|OG002|Outcome|Cohort 2: GSK3772847 140 mg SC|Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.
11344787|NCT04366349|OG003|Outcome|Cohorts 3 and 4: Placebo SC|Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.
11344788|NCT04366349|OG004|Outcome|Cohort 3: GSK3772847 140 mg SC in Japanese Participants|Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.
11344789|NCT04366349|OG005|Outcome|Cohort 4: GSK3772847 140 mg SC in Chinese Participants|Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
11344790|NCT04366349|OG000|Outcome|Cohort 1: GSK3772847 70 mg SC|Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.
11344791|NCT04366349|OG001|Outcome|Cohort 2: GSK3772847 140 mg SC|Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.
11344792|NCT04366349|OG002|Outcome|Cohort 3: GSK3772847 140 mg SC in Japanese Participants|Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.
11344793|NCT04366349|OG003|Outcome|Cohort 4: GSK3772847 140 mg SC in Chinese Participants|Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
11344794|NCT04366349|EG000|Reported Event|Cohorts 1 and 2: Placebo SC|Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.
11344795|NCT04366349|EG001|Reported Event|Cohort 1: GSK3772847 70 mg SC|Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.
11344796|NCT04366349|EG002|Reported Event|Cohort 2: GSK3772847 140 mg SC|Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.
11344797|NCT04366349|EG003|Reported Event|Cohorts 3 and 4: Placebo SC|Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.
11344798|NCT04366349|EG004|Reported Event|Cohort 3: GSK3772847 140 mg SC in Japanese Participants|Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.
11344799|NCT04366349|EG005|Reported Event|Cohort 4: GSK3772847 140 mg SC in Chinese Participants|Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
11344800|NCT04369885|BG000|Baseline|Home Telemedicine Device|"This arm will receive the intervention of the home telemedicine device for three months.~Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter: All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and QoL Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a UNC clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them."
11344801|NCT04369885|FG000|Participant Flow|Home Telemedicine Device|"This arm will receive the intervention of the home telemedicine device for three months.~Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter: All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and QoL Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a UNC clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them."
10976573|NCT00941031|EG008|Reported Event|FOLLOW-UP: Start of Relapse|FOLLOW-UP: Treatment at start of relapse regimen - 'SR'
10976574|NCT00941031|EG009|Reported Event|FOLLOW-UP: Open Label|FOLLOW-UP: Open label
11348536|NCT04160975|BG003|Baseline|Black Participant-Discordant Sender-Expert Sender-Acknowledgement Signal|Black participants who are assigned to a discordant-exper sender delivering a acknowledgement signal.
11348537|NCT04160975|BG004|Baseline|White Participant-Concordant Sender-Expert Sender-Standard Signal|White participants who are assigned to a concordant-exper sender delivering a standard signal.
11344802|NCT04369885|OG000|Outcome|Home Telemedicine Device|"This arm will receive the intervention of the home telemedicine device for three months.~Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter: All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and QoL Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a UNC clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them."
11344803|NCT04369885|EG000|Reported Event|Home Telemedicine Device|"This arm will receive the intervention of the home telemedicine device for three months.~Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter: All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and QoL Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a UNC clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them."
11344804|NCT04373421|BG000|Baseline|Chlorhexidine Gluconate Plus Benzydamine Hydrochloride|Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects. The most common side effect of chlorhexidine is oral discoloration, taste changes and allergic responses. Furthermore, it has been reported that chlorhexidine has cytotoxic effect on gingival fibroblasts, epithelial cells, neutrophils and red blood cells; also shows incremental trend in genotoxicity as the duration of usage is increased. Benzydamine hydrochloride is a nonsteroidal anti-inflammatory drug that elicits anti-inflammatory, analgesic, anesthetic and antimicrobial effects. It is often used in addition to the topical application of chlorhexidine.. However, side effects such as urticaria, erythema, pruritus, photosensitivity, bronchospasm and renal problems can be observed associated with the use of benzydamine.
11344805|NCT04373421|BG001|Baseline|St. John's Wort Oil|St. John's Wort (Hypericum perforatum) is a European medicinal plant with a history of more than 2000 years which possessing a variety of important constituents including phloroglucinols (hyperforin and adhyperforin), naphthodianthrones (hypericin and pseudohypericin), xanthones, essential oil, biflavones (biapigenin and amentoflavone), flavonol derivatives and phenolic compounds. The important components of St. John's Wort such as hypericin and hyperforin exert anti-inflammatory, antimicrobial, anticancer effects as well as stimulating tissue growth and differentiation. Hypericin exhibits anti-inflammatory effects by inhibiting the production of interleukin-12; whereas hyperforin reveals this effect by inhibiting the mechanisms of cyclooxygenase 1, 5-lipoxygenase and prostaglandin E2. St. John's Wort oil is extracted by maceration of the hypericum herb in carrier oil, such as virgin olive oil.
11344806|NCT04373421|BG002|Baseline|Virgin Olive Oil|The olive oil, a product extracted from the fruit of Olea europaea, exerts also antioxidant and anti-inflammatory effects due to its important contents including oleic acids, phenolic acids, secoiridoids and flavonoids. The oral application of olive oil has been shown to have protective anti-inflammatory effects and accelerated epithelial healing.
11344807|NCT04373421|BG003|Baseline|Total|Total of all reporting groups
11344808|NCT04373421|FG000|Participant Flow|Chlorhexidine Gluconate Plus Benzydamine Hydrochloride|Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects. The most common side effect of chlorhexidine is oral discoloration, taste changes and allergic responses. Furthermore, it has been reported that chlorhexidine has cytotoxic effect on gingival fibroblasts, epithelial cells, neutrophils and red blood cells; also shows incremental trend in genotoxicity as the duration of usage is increased. Benzydamine hydrochloride is a nonsteroidal anti-inflammatory drug that elicits anti-inflammatory, analgesic, anesthetic and antimicrobial effects. It is often used in addition to the topical application of chlorhexidine.. However, side effects such as urticaria, erythema, pruritus, photosensitivity, bronchospasm and renal problems can be observed associated with the use of benzydamine. Patients were also instructed to rinse their mouth with 15 ml of chlorhexidine gluconate plus benzydamine for 30 s, 3 times a day, and continue until the 7th postoperative day.
11344809|NCT04373421|FG001|Participant Flow|St. John's Wort Oil|St. John's Wort (Hypericum perforatum) is a European medicinal plant with a history of more than 2000 years which possessing a variety of important constituents including phloroglucinols (hyperforin and adhyperforin), naphthodianthrones (hypericin and pseudohypericin), xanthones, essential oil, biflavones (biapigenin and amentoflavone), flavonol derivatives and phenolic compounds. The important components of St. John's Wort such as hypericin and hyperforin exert anti-inflammatory, antimicrobial, anticancer effects as well as stimulating tissue growth and differentiation. Hypericin exhibits anti-inflammatory effects by inhibiting the production of interleukin-12; whereas hyperforin reveals this effect by inhibiting the mechanisms of cyclooxygenase 1, 5-lipoxygenase and prostaglandin E2. St. John's Wort oil is extracted by maceration of the hypericum herb in carrier oil, such as virgin olive oil. Patients were also instructed to rinse their mouth with 15 ml of St. John's oil for 30 s, 3 times a day, and continue until the 7th postoperative day.
11344810|NCT04373421|FG002|Participant Flow|Virgin Olive Oil|The olive oil, a product extracted from the fruit of Olea europaea, exerts also antioxidant and anti-inflammatory effects due to its important contents including oleic acids, phenolic acids, secoiridoids and flavonoids. The oral application of olive oil has been shown to have protective anti-inflammatory effects and accelerated epithelial healing. Patients were also instructed to rinse their mouth with 15 ml of virgin olive oil for 30 s, 3 times a day, and continue until the 7th postoperative day.
11348538|NCT04160975|BG005|Baseline|White Participant-Discordant Sender-Expert Sender-Standard Signal|White participants who are assigned to a discordant-exper sender delivering a standard signal.
11348539|NCT04160975|BG006|Baseline|Total|Total of all reporting groups
11348540|NCT04160975|FG000|Participant Flow|Black Participant-Concordant Sender-Expert Sender-Standard Signal|Black participants who are assigned to a concordant-exper sender delivering a standard signal.
11007026|NCT01089062|EG000|Reported Event|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
11344811|NCT04373421|OG000|Outcome|Chlorhexidine Gluconate Plus Benzydamine Hydrochloride|Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride: After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
11344812|NCT04373421|OG001|Outcome|St. John's Wort Oil|St. John's wort oil: After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
11344813|NCT04373421|OG002|Outcome|Virgin Olive Oil|Virgin olive oil: After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
11344814|NCT04373421|OG000|Outcome|Chlorhexidine Gluconate Plus Benzydamine Hydrochloride|Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects. The most common side effect of chlorhexidine is oral discoloration, taste changes and allergic responses. Furthermore, it has been reported that chlorhexidine has cytotoxic effect on gingival fibroblasts, epithelial cells, neutrophils and red blood cells; also shows incremental trend in genotoxicity as the duration of usage is increased. Benzydamine hydrochloride is a nonsteroidal anti-inflammatory drug that elicits anti-inflammatory, analgesic, anesthetic and antimicrobial effects. It is often used in addition to the topical application of chlorhexidine.. However, side effects such as urticaria, erythema, pruritus, photosensitivity, bronchospasm and renal problems can be observed associated with the use of benzydamine.
11344815|NCT04373421|OG001|Outcome|St. John's Wort Oil|St. John's Wort (Hypericum perforatum) is a European medicinal plant with a history of more than 2000 years which possessing a variety of important constituents including phloroglucinols (hyperforin and adhyperforin), naphthodianthrones (hypericin and pseudohypericin), xanthones, essential oil, biflavones (biapigenin and amentoflavone), flavonol derivatives and phenolic compounds. The important components of St. John's Wort such as hypericin and hyperforin exert anti-inflammatory, antimicrobial, anticancer effects as well as stimulating tissue growth and differentiation. Hypericin exhibits anti-inflammatory effects by inhibiting the production of interleukin-12; whereas hyperforin reveals this effect by inhibiting the mechanisms of cyclooxygenase 1, 5-lipoxygenase and prostaglandin E2. St. John's Wort oil is extracted by maceration of the hypericum herb in carrier oil, such as virgin olive oil.
11344816|NCT04373421|OG002|Outcome|Virgin Olive Oil|The olive oil, a product extracted from the fruit of Olea europaea, exerts also antioxidant and anti-inflammatory effects due to its important contents including oleic acids, phenolic acids, secoiridoids and flavonoids. The oral application of olive oil has been shown to have protective anti-inflammatory effects and accelerated epithelial healing.
11344817|NCT04373421|EG000|Reported Event|Chlorhexidine Gluconate Plus Benzydamine Hydrochloride|Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride: After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
11348541|NCT04160975|FG001|Participant Flow|Black Participant-Concordant Sender-Lay Sender-Standard Signal|Black participants who are assigned to a concordant-lay sender delivering a standard signal.
11348542|NCT04160975|FG002|Participant Flow|Black Participant-Discordant Sender-Expert Sender-Standard Signal|Black participants who are assigned to a discordant-exper sender delivering a standard signal.
11007027|NCT01089062|EG001|Reported Event|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
11348543|NCT04160975|FG003|Participant Flow|Black Participant-Discordant Sender-Expert Sender-Acknowledgement Signal|Black participants who are assigned to a discordant-exper sender delivering a acknowledgement signal.
11348544|NCT04160975|FG004|Participant Flow|White Participant-Concordant Sender-Expert Sender-Standard Signal|White participants who are assigned to a concordant-exper sender delivering a standard signal.
11007028|NCT01089062|EG002|Reported Event|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
11344818|NCT04373421|EG001|Reported Event|St. John's Wort Oil|St. John's wort oil: After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
11344819|NCT04373421|EG002|Reported Event|Virgin Olive Oil|Virgin olive oil: After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
11344820|NCT04381728|BG000|Baseline|Womed Leaf|"At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film.~Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment.~A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion."
11344821|NCT04381728|FG000|Participant Flow|Womed Leaf|"At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film.~Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment.~A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion."
11344822|NCT04381728|OG000|Outcome|Womed Leaf|"At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film.~Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment.~A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion."
11344823|NCT04381728|EG000|Reported Event|Womed Leaf|"At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film.~Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment.~A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion."
11344824|NCT04388826|BG000|Baseline|Number of Patients Exposed to Veru-111 18 mg|"Veru-111 18mg capsules~Veru-111: Respiratory Distress Syndrome, Adult"
11344825|NCT04388826|BG001|Baseline|Number of Patients Exposed to Placebo|"Placebo capsules~Veru-111: Respiratory Distress Syndrome, Adult"
10855226|NCT00328016|FG000|Participant Flow|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period.
11344826|NCT04388826|BG002|Baseline|Total|Total of all reporting groups
11344827|NCT04388826|FG000|Participant Flow|Veru-111 18 mg QD|"Veru-111 18mg capsules~Veru-111: Respiratory Distress Syndrome, Adult"
11344828|NCT04388826|FG001|Participant Flow|Placebo QD|"Placebo capsules~Veru-111: Respiratory Distress Syndrome, Adult"
11344829|NCT04388826|OG000|Outcome|Veru-111 18 mg|"Veru-111 18mg capsules~Veru-111: Respiratory Distress Syndrome, Adult"
11344830|NCT04388826|OG001|Outcome|Placebo|"Placebo capsules~Veru-111: Respiratory Distress Syndrome, Adult"
11344831|NCT04388826|EG000|Reported Event|Veru-111 18 mg|"Veru-111 18mg capsules~Veru-111: Respiratory Distress Syndrome, Adult"
11344832|NCT04388826|EG001|Reported Event|Placebo|"Placebo capsules~Veru-111: Respiratory Distress Syndrome, Adult"
11344833|NCT04394845|BG000|Baseline|[18F]GTP1|Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
11344834|NCT04394845|FG000|Participant Flow|[18F]GTP1|Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
11344835|NCT04394845|OG000|Outcome|[18F]GTP1|Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
11344836|NCT04394845|OG000|Outcome|[18F]GTP1 Female|Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
11344837|NCT04394845|OG001|Outcome|[18F]GTP1 Male|Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
11344838|NCT04394845|EG000|Reported Event|[18F]GTP1|Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
11344839|NCT04398732|BG000|Baseline|Etanercept|Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.
11348545|NCT04160975|FG005|Participant Flow|White Participant-Discordant Sender-Expert Sender-Standard Signal|White participants who are assigned to a discordant-exper sender delivering a standard signal.
11222920|NCT02349633|OG001|Outcome|Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD|Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
11222921|NCT02349633|OG002|Outcome|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11222922|NCT02349633|OG002|Outcome|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222923|NCT02349633|OG003|Outcome|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222924|NCT02349633|OG004|Outcome|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11222925|NCT02349633|OG000|Outcome|PF-06747775 200 mg QD Group|Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1. Only participants in Japan LIC and Phase 2 Cohort 1 were eligible for OS evaluation.
11222926|NCT02349633|OG007|Outcome|Phase 2 Cohort 1: PF-06747775 200 mg QD|Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycle (up to a maximum of 28 weeks).
11222927|NCT02349633|OG008|Outcome|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222928|NCT02349633|OG009|Outcome|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222929|NCT02349633|OG000|Outcome|Phase 1 Sildenafil Sub-study: PF-06747775 200 mg QD + Sildenafil 25 mg|Participants received a single dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD through Cycle 1 Day 1 to Cycle 1 Day 11 plus a single dose of sildenafil 25 mg on Cycle 1 Day 11 (up to a maximum of 165 weeks).
11222930|NCT02349633|OG001|Outcome|Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD|Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
11222931|NCT02349633|OG000|Outcome|Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin|Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
11222932|NCT02349633|OG000|Outcome|Phase 1 Esomeprazole-Itraconazole DDI Sub-study: PF-06747775 200 mg + Esomeprazole/Itraconazole|Participants received PF-06747775 QD for 21-day cycle at 200 mg on Cycle 1 Day 1-14 then 100 mg starting from Cycle 1 Day 15. On Cycle 1 Day 9-13, a 40 mg dose of esomeprazole was given to participants 2 hours prior to PF-06747775. On Cycle 1 Day 17-20, a 200 mg dose of itraconazole was given to participants at the same time with PF-06747775. On Cycle 1 Day 21, itraconazole 200 mg was given to participants 3 hours prior to PF-06747775 (up to a maximum of 165 weeks).
11222933|NCT02349633|OG000|Outcome|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11222934|NCT02349633|OG000|Outcome|Japan LIC RP2D Cohort: PF-06747775 200 mg SD => 200 mg QD|Japanese participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycle (up to a maximum of 61 weeks).
11222935|NCT02349633|OG001|Outcome|Japan LIC PK Cohort: PF-06747775 100 mg SD => 200 mg QD|Japanese participants received a single dose of PF-06747775 100 mg on Day -7 in lead-in period, followed by continuous dosing of PF-06747775 200 mg QD for 21-day cycle (up to a maximum of 25 weeks).
11222936|NCT02349633|EG000|Reported Event|Phase 1 Dose-escalation: PF-06747775 25 mg QD|Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks).
11222937|NCT02349633|EG001|Reported Event|Phase 1 Dose-escalation: PF-06747775 50 mg QD|Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks).
11222938|NCT02349633|EG002|Reported Event|Phase 1 Dose-escalation: PF-06747775 150 mg QD|Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks).
11222939|NCT02349633|EG003|Reported Event|Phase 1 Dose-escalation: PF-06747775 275 mg QD|Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks).
11222940|NCT02349633|EG004|Reported Event|Phase 1 Dose-escalation: PF-06747775 300 mg QD|Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks).
11344840|NCT04398732|FG000|Participant Flow|Etanercept|Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 milligrams [mg] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.
11344841|NCT04398732|OG000|Outcome|Etanercept|Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.
11344842|NCT04398732|OG000|Outcome|Etanercept: Participants Adherent to Treatment|Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice and were adherent to treatment. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.
11344843|NCT04398732|OG001|Outcome|Etanercept: Participants Not Adherent to Treatment|Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real clinical practice and were not adherent to treatment. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.
11344844|NCT04398732|EG000|Reported Event|Etanercept|Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.
11344845|NCT04401293|BG000|Baseline|Full Dose LMWH Anticoagulation Therapy|"Subjects in this study arm will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin). Enoxaparin 1mg/kg SQ BID for CrCl ≥ 30ml/min (or Enoxaparin 0.5mg/kg SQ BID for CrCl ≥ 15ml/min and < 30ml/min) during the course of their hospitalization.~Enoxaparin: Full Dose LMWH anticoagulation therapy"
11344846|NCT04401293|BG001|Baseline|Prophylactic/Intermediate Dose LMWH or UFH Therapy|"Subjects in this study arm will be treated with Local institutional standard-of-care for prophylactic-dose or intermediate-dose UFH or LMWH. Regimens allowed are UFH up to 22,500 IU daily in BID or TID doses (i.e. UFH 5000 IU SQ BID/TID or 7500 IU BID/TID), enoxaparin 30mg and 40mg SQ QD or BID (the use of weight-based enoxaparin i.e. 0.5mg/kg SQ BID for this arm is acceptable but strongly discouraged), dalteparin 2500IU or 5000IU QD.~Prophylactic/Intermediate Dose Enoxaparin: Prophylactic/Intermediate Dose LMWH or UFH therapy"
11344847|NCT04401293|BG002|Baseline|Total|Total of all reporting groups
11344848|NCT04401293|FG000|Participant Flow|Full Dose LMWH Anticoagulation Therapy|"Subjects in this study arm will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin). Enoxaparin 1mg/kg SQ BID for CrCl ≥ 30ml/min (or Enoxaparin 0.5mg/kg SQ BID for CrCl ≥ 15ml/min and < 30ml/min) during the course of their hospitalization.~Enoxaparin: Full Dose LMWH anticoagulation therapy"
11344849|NCT04401293|FG001|Participant Flow|Prophylactic/Intermediate Dose LMWH or UFH Therapy|"Subjects in this study arm will be treated with Local institutional standard-of-care for prophylactic-dose or intermediate-dose UFH or LMWH. Regimens allowed are UFH up to 22,500 IU daily in BID or TID doses (i.e. UFH 5000 IU SQ BID/TID or 7500 IU BID/TID), enoxaparin 30mg and 40mg SQ QD or BID (the use of weight-based enoxaparin i.e. 0.5mg/kg SQ BID for this arm is acceptable but strongly discouraged), dalteparin 2500IU or 5000IU QD.~Prophylactic/Intermediate Dose Enoxaparin: Prophylactic/Intermediate Dose LMWH or UFH therapy"
11344850|NCT04401293|OG000|Outcome|Full Dose LMWH Anticoagulation Therapy|"Subjects in this study arm will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin). Enoxaparin 1mg/kg SQ BID for CrCl ≥ 30ml/min (or Enoxaparin 0.5mg/kg SQ BID for CrCl ≥ 15ml/min and < 30ml/min) during the course of their hospitalization.~Enoxaparin: Full Dose LMWH anticoagulation therapy"
11344851|NCT04401293|OG001|Outcome|Prophylactic/Intermediate Dose LMWH or UFH Therapy|"Subjects in this study arm will be treated with Local institutional standard-of-care for prophylactic-dose or intermediate-dose UFH or LMWH. Regimens allowed are UFH up to 22,500 IU daily in BID or TID doses (i.e. UFH 5000 IU SQ BID/TID or 7500 IU BID/TID), enoxaparin 30mg and 40mg SQ QD or BID (the use of weight-based enoxaparin i.e. 0.5mg/kg SQ BID for this arm is acceptable but strongly discouraged), dalteparin 2500IU or 5000IU QD.~Prophylactic/Intermediate Dose Enoxaparin: Prophylactic/Intermediate Dose LMWH or UFH therapy"
11344852|NCT04401293|EG000|Reported Event|Full Dose LMWH Anticoagulation Therapy|"Subjects in this study arm will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin). Enoxaparin 1mg/kg SQ BID for CrCl ≥ 30ml/min (or Enoxaparin 0.5mg/kg SQ BID for CrCl ≥ 15ml/min and < 30ml/min) during the course of their hospitalization.~Enoxaparin: Full Dose LMWH anticoagulation therapy"
11344853|NCT04401293|EG001|Reported Event|Prophylactic/Intermediate Dose LMWH or UFH Therapy|"Subjects in this study arm will be treated with Local institutional standard-of-care for prophylactic-dose or intermediate-dose UFH or LMWH. Regimens allowed are UFH up to 22,500 IU daily in BID or TID doses (i.e. UFH 5000 IU SQ BID/TID or 7500 IU BID/TID), enoxaparin 30mg and 40mg SQ QD or BID (the use of weight-based enoxaparin i.e. 0.5mg/kg SQ BID for this arm is acceptable but strongly discouraged), dalteparin 2500IU or 5000IU QD.~Prophylactic/Intermediate Dose Enoxaparin: Prophylactic/Intermediate Dose LMWH or UFH therapy"
11344854|NCT04411628|BG000|Baseline|Placebo|Participants received single dose of Placebo as intravenous infusion.
11344855|NCT04411628|BG001|Baseline|700 mg LY3819253 IV|Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.
11344856|NCT04411628|BG002|Baseline|2800 mg LY3819253 IV|Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.
11344857|NCT04411628|BG003|Baseline|7000 mg LY3819253 IV|Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
11344858|NCT04411628|BG004|Baseline|Total|Total of all reporting groups
11344859|NCT04411628|FG000|Participant Flow|Placebo|Participants received single dose of Placebo as intravenous infusion.
11344860|NCT04411628|FG001|Participant Flow|700 mg LY3819253 IV|Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.
11344861|NCT04411628|FG002|Participant Flow|2800 mg LY3819253 IV|Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.
11344862|NCT04411628|FG003|Participant Flow|7000 mg LY3819253 IV|Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
11344863|NCT04411628|OG000|Outcome|Placebo|Participants received single dose of Placebo as intravenous infusion.
11344864|NCT04411628|OG001|Outcome|700 mg LY3819253 IV|Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.
11344865|NCT04411628|OG002|Outcome|2800 mg LY3819253 IV|Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.
11344866|NCT04411628|OG003|Outcome|7000 mg LY3819253 IV|Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
11344867|NCT04411628|OG000|Outcome|700 mg LY3819253 IV|Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.
11344868|NCT04411628|OG001|Outcome|2800 mg LY3819253 IV|Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.
11344869|NCT04411628|OG002|Outcome|7000 mg LY3819253 IV|Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
11344870|NCT04411628|EG000|Reported Event|Placebo|Participants received single dose of Placebo as intravenous infusion.
11344871|NCT04411628|EG001|Reported Event|700 mg LY3819253 IV|Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.
11344872|NCT04411628|EG002|Reported Event|2800 mg LY3819253 IV|Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.
11344873|NCT04411628|EG003|Reported Event|7000 mg LY3819253 IV|Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
11344874|NCT04418947|BG000|Baseline|No Intervention|No letter was sent to the patient.
11344875|NCT04418947|BG001|Baseline|MPM Control Letter|Communication type: Control letter vs. intervention letter
11344876|NCT04418947|BG002|Baseline|MPM Intervention Letter|Communication type: Control letter vs. intervention letter
11344877|NCT04418947|BG003|Baseline|Mailed Control Letter|Communication type: Control letter vs. intervention letter
11344878|NCT04418947|BG004|Baseline|Mailed Intervention Letter|Communication type: Control letter vs. intervention letter
11344879|NCT04418947|BG005|Baseline|Total|Total of all reporting groups
11344880|NCT04418947|FG000|Participant Flow|No Intervention|No letter sent to the patient
11344881|NCT04418947|FG001|Participant Flow|MPM Control Letter|Communication type: Control letter vs. intervention letter
11344882|NCT04418947|FG002|Participant Flow|MPM Intervention Letter|Communication type: Control letter vs. intervention letter
11344883|NCT04418947|FG003|Participant Flow|Mailed Control Letter|Communication type: Control letter vs. intervention letter
11344884|NCT04418947|FG004|Participant Flow|Mailed Intervention Letter|Communication type: Control letter vs. intervention letter
11344885|NCT04418947|OG000|Outcome|No Intervention|No letter was sent to the patient.
11344886|NCT04418947|OG001|Outcome|MPM Control Letter|Communication type: Control letter vs. intervention letter
11344887|NCT04418947|OG002|Outcome|MPM Intervention Letter|Communication type: Control letter vs. intervention letter
11344888|NCT04418947|OG003|Outcome|Mailed Control Letter|Communication type: Control letter vs. intervention letter
11344889|NCT04418947|OG004|Outcome|Mailed Intervention Letter|Communication type: Control letter vs. intervention letter
11344890|NCT04418947|EG000|Reported Event|No Intervention|No letter was sent to the patient.
11344891|NCT04418947|EG001|Reported Event|MPM Control Letter|Communication type: Control letter vs. intervention letter
11344892|NCT04418947|EG002|Reported Event|MPM Intervention Letter|Communication type: Control letter vs. intervention letter
11344893|NCT04418947|EG003|Reported Event|Mailed Control Letter|Communication type: Control letter vs. intervention letter
11344894|NCT04418947|EG004|Reported Event|Mailed Intervention Letter|Communication type: Control letter vs. intervention letter
11344895|NCT04420273|BG000|Baseline|SSE Educational Intervention|"Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.~SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE."
11344896|NCT04420273|BG001|Baseline|Active Control: Healthy Living|"Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.~Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living."
11344897|NCT04420273|BG002|Baseline|Total|Total of all reporting groups
11344898|NCT04420273|FG000|Participant Flow|SSE Educational Intervention|"Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.~SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE."
11344899|NCT04420273|FG001|Participant Flow|Active Control: Healthy Living|"Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.~Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living."
11344900|NCT04420273|OG000|Outcome|SSE Educational Intervention|"Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.~SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE."
11344901|NCT04420273|OG001|Outcome|Active Control: Healthy Living|"Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.~Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living."
11344902|NCT04420273|EG000|Reported Event|SSE Educational Intervention|"Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.~SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE."
11344903|NCT04420273|EG001|Reported Event|Active Control: Healthy Living|"Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.~Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living."
11344904|NCT04420572|BG000|Baseline|Ozone Injection Group|The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.
11344905|NCT04420572|BG001|Baseline|Steroid Injection Group|A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
11344906|NCT04420572|BG002|Baseline|Total|Total of all reporting groups
11344907|NCT04420572|FG000|Participant Flow|Ozone Injection Group|The patients in the OI group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study
11344908|NCT04420572|FG001|Participant Flow|Steroid Injection Group|A single dose injection was given to the patients in the CSI group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
11344909|NCT04420572|OG000|Outcome|Ozone Injection Group|The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.
10855227|NCT00328016|FG001|Participant Flow|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery period.
10855228|NCT00328016|OG000|Outcome|Device Guided Breathing|Practiced slow breathing using Guided Breathing Device
10855229|NCT00328016|OG001|Outcome|Control Group|Practiced passive attention to breathing
11222941|NCT02349633|EG005|Reported Event|Phase 1 Dose-escalation: PF-06747775 450 mg QD|Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks).
11222942|NCT02349633|EG006|Reported Event|Phase 1 Dose-escalation: PF-06747775 600 mg QD|Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks).
11222943|NCT02349633|EG007|Reported Event|PF-06747775 200 mg QD Group|Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1.
11222944|NCT02349633|EG008|Reported Event|Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD|Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11.
11222945|NCT02349633|EG009|Reported Event|Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD|Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks).
11222946|NCT02349633|EG010|Reported Event|Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin|Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination.
11222947|NCT02349633|EG011|Reported Event|Phase 2 Cohort 2B: PF-06747775 + Palbociclib|Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222948|NCT02349633|EG012|Reported Event|Phase 2 Cohort 2B: PF-06747775 Single Agent|Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination.
11222949|NCT02349633|EG013|Reported Event|Phase 1b Cohort 3: PF-06747775 + Avelumab|Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination.
11222950|NCT02349646|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11222951|NCT02349646|FG000|Participant Flow|Axium DRG Neurostimulator|All subects implanted with intent to treat with the Axium DRG Neurostimulator
11222952|NCT02349646|OG000|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
11222953|NCT02349646|EG000|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
11222954|NCT02349685|BG000|Baseline|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
11222955|NCT02349685|BG001|Baseline|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
11222956|NCT02349685|BG002|Baseline|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
11222957|NCT02349685|BG003|Baseline|Total|Total of all reporting groups
11222958|NCT02349685|FG000|Participant Flow|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
11222959|NCT02349685|FG001|Participant Flow|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
11222960|NCT02349685|FG002|Participant Flow|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
11222961|NCT02349685|OG000|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
11222962|NCT02349685|OG001|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
11344910|NCT04420572|OG001|Outcome|Steroid Injection Group|A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
11344911|NCT04420572|EG000|Reported Event|Ozone Injection Group|The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.
11344912|NCT04420572|EG001|Reported Event|Steroid Injection Group|A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
11344913|NCT04428411|BG000|Baseline|Etanercept|Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied in this observational study.
11344914|NCT04428411|FG000|Participant Flow|Etanercept|Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 milligrams [mg] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied in this observational study.
11344915|NCT04428411|OG000|Outcome|Etanercept: Participants With Difficult to Treat Sites|Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.
11344916|NCT04428411|OG001|Outcome|Etanercept: Participants Without Difficult to Treat Sites|Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.
11344917|NCT04428411|OG000|Outcome|Etanercept: Participants Adherent to Treatment|Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and were adherent to treatment.
11344918|NCT04428411|OG001|Outcome|Etanercept: Participants Not Adherent to Treatment|Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and were not adherent to treatment.
11344919|NCT04428411|EG000|Reported Event|Etanercept|Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied in this observational study.
11344920|NCT04435184|BG000|Baseline|Crizanlizumab|"Crizanlizumab is a monoclonal antibody targeting P-selectin. Crizanlizumab 5.0 mg/kg in 100 ml IV once.~Crizanlizumab: Crizanlizumab 5.0 mg/kg in 100 ml IV once."
11344921|NCT04435184|BG001|Baseline|Placebo Saline|"0.9% saline 100 ml IV once.~0.9% saline: 0.9% saline 100 ml IV once."
11344922|NCT04435184|BG002|Baseline|Total|Total of all reporting groups
11344923|NCT04435184|FG000|Participant Flow|Crizanlizumab|"Crizanlizumab is a monoclonal antibody targeting P-selectin. Crizanlizumab 5.0 mg/kg in 100 ml IV once.~Crizanlizumab: Crizanlizumab 5.0 mg/kg in 100 ml IV once."
11344924|NCT04435184|FG001|Participant Flow|Placebo Saline|"0.9% saline 100 ml IV once.~0.9% saline: 0.9% saline 100 ml IV once."
11344925|NCT04435184|OG000|Outcome|Crizanlizumab|"Crizanlizumab is a monoclonal antibody targeting P-selectin. Crizanlizumab 5.0 mg/kg in 100 ml IV once.~Crizanlizumab: Crizanlizumab 5.0 mg/kg in 100 ml IV once."
11344926|NCT04435184|OG001|Outcome|Placebo Saline|"0.9% saline 100 ml IV once.~0.9% saline: 0.9% saline 100 ml IV once."
11344927|NCT04435184|EG000|Reported Event|Crizanlizumab|"Crizanlizumab is a monoclonal antibody targeting P-selectin. Crizanlizumab 5.0 mg/kg in 100 ml IV once.~Crizanlizumab: Crizanlizumab 5.0 mg/kg in 100 ml IV once."
11344928|NCT04435184|EG001|Reported Event|Placebo Saline|"0.9% saline 100 ml IV once.~0.9% saline: 0.9% saline 100 ml IV once."
10855230|NCT00328016|OG000|Outcome|Device Guided Breathing|Practiced slow breathing using guided breathing device
11344929|NCT04476784|BG000|Baseline|LID018869, Then Biofinity|Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
11344930|NCT04476784|BG001|Baseline|Biofinity, Then LID018869|Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
11344931|NCT04476784|BG002|Baseline|Total|Total of all reporting groups
11344932|NCT04476784|FG000|Participant Flow|LID018869, Then Biofinity|Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
11344933|NCT04476784|FG001|Participant Flow|Biofinity, Then LID018869|Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
11344934|NCT04476784|OG000|Outcome|LID018869|Lehfilcon A contact lenses worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
11344935|NCT04476784|OG001|Outcome|Biofinity|Comfilcon A contact lenses worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
11344936|NCT04476784|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
11344937|NCT04476784|EG001|Reported Event|LID018869 - Ocular|Events reported in this group occurred while exposed to lehfilcon A contact lenses
11344938|NCT04476784|EG002|Reported Event|LID018869 - Nonocular|Events reported in this group occurred while exposed to lehfilcon A contact lenses
11344939|NCT04476784|EG003|Reported Event|Biofinity - Ocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
11344940|NCT04476784|EG004|Reported Event|Biofinity - Nonocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
11344941|NCT04484207|BG000|Baseline|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to the participants~A short video intervention: Three minute video of a veteran who shares his personal story"
11344942|NCT04484207|BG001|Baseline|Vignette Intervention|"A brief vignette about coping with COVID-19 stress presented to the participants~A vignette intervention: A written description of the content of the video"
11344943|NCT04484207|BG002|Baseline|Control|Only assessment, no intervention arrm
11344944|NCT04484207|BG003|Baseline|Total|Total of all reporting groups
11344945|NCT04484207|FG000|Participant Flow|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to the participants~A short video intervention: Three minute video of a veteran who shares his personal story"
11344946|NCT04484207|FG001|Participant Flow|Vignette Intervention|"A brief vignette about coping with COVID-19 stress presented to the participants~A vignette intervention: A written description of the content of the video"
11344947|NCT04484207|FG002|Participant Flow|Control|Only assessment, no intervention arrm
11344948|NCT04484207|OG000|Outcome|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to the participants~A short video intervention: Three minute video of a veteran who shares his personal story"
11344949|NCT04484207|OG001|Outcome|Vignette Intervention|"A brief vignette about coping with COVID-19 stress presented to the participants~A vignette intervention: A written description of the content of the video"
11344950|NCT04484207|OG002|Outcome|Control|Only assessment, no intervention arrm
11344951|NCT04484207|OG000|Outcome|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to participants who reported anxiety, depression, or PTSD.~A short video intervention: Three minute video of a veteran who shares his personal story"
11344952|NCT04484207|OG001|Outcome|Vignette Intervention|"A brief vignette about coping with COVID-19 stress presented to participants who reported anxiety, depression, or PTSD.~A vignette intervention: A written description of the content of the video"
11344953|NCT04484207|OG002|Outcome|Control|Only assessment, no intervention arm provided to participants who reported anxiety, depression, or PTSD.
11344954|NCT04484207|EG000|Reported Event|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to the participants~A short video intervention: Three minute video of a veteran who shares his personal story"
11344955|NCT04484207|EG001|Reported Event|Vignette Intervention|"A brief vignette about coping with COVID-19 stress presented to the participants~A vignette intervention: A written description of the content of the video"
11344956|NCT04484207|EG002|Reported Event|Control|Only assessment, no intervention arrm
11344957|NCT04485455|BG000|Baseline|iTBS Open Label|All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
11344958|NCT04485455|FG000|Participant Flow|iTBS Open Label|All subjects enrolled into this study were in the same group, with all receiving active Intermittent Theta Burst Stimulation (iTBS) treatment.
11344959|NCT04485455|OG000|Outcome|iTBS Open Label|All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
11344960|NCT04485455|EG000|Reported Event|iTBS Open Label|All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
11344961|NCT04495283|BG000|Baseline|PGB and APAP (Group A)|Group A receives PGB plus APAP prior to surgery and placebo 1 post-surgery.
11344962|NCT04495283|BG001|Baseline|APAP (Group B)|Group B receives placebo 2 prior to surgery and APAP post-surgery.
11344963|NCT04495283|BG002|Baseline|Placebo (Group C).|Group C receives placebo 1 prior to surgery and placebo 2 post-surgery.
11344964|NCT04495283|BG003|Baseline|Total|Total of all reporting groups
11344965|NCT04495283|FG000|Participant Flow|PGB and APAP (Group A)|Group A receives pregabalin (PGB) plus acetaminophen (APAP) prior to surgery and placebo 1 post-surgery.
11344966|NCT04495283|FG001|Participant Flow|APAP (Group B)|Group B receives placebo 2 prior to surgery and APAP post-surgery.
11344967|NCT04495283|FG002|Participant Flow|Placebo (Group C).|Group C receives placebo 1 prior to surgery and placebo 2 post-surgery.
11344968|NCT04495283|OG000|Outcome|PGB and APAP (Group A)|Group A receives PGB plus APAP prior to surgery and placebo 1 post-surgery.
11344969|NCT04495283|OG001|Outcome|Placebo (Group C).|Group C receives placebo 1 prior to surgery and placebo 2 post-surgery
11344970|NCT04495283|OG001|Outcome|APAP (Group B)|Group B receives placebo 2 prior to surgery and APAP post-surgery.
11344971|NCT04495283|OG002|Outcome|Placebo (Group C).|Group C receives placebo 1 prior to surgery and placebo 2 post-surgery
11344972|NCT04495283|OG002|Outcome|Placebo (Group C).|Group C receives placebo 1 prior to surgery and placebo 2 post-surgery.
11344973|NCT04495283|OG001|Outcome|APAP (Group B)|Group B receives placebo 2 prior to surgery and APAP post-surgery
11344974|NCT04495283|EG000|Reported Event|PGB and APAP (Group A)|Group A receives PGB plus APAP prior to surgery and placebo 1 post-surgery.
11344975|NCT04495283|EG001|Reported Event|APAP (Group B)|Group B receives placebo 2 prior to surgery and APAP post-surgery
11344976|NCT04495283|EG002|Reported Event|Placebo (Group C).|Group C receives placebo 1 prior to surgery and placebo 2 post-surgery
11344977|NCT04497948|BG000|Baseline|Acalabrutinib + BSC + PPI|Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
11344978|NCT04497948|FG000|Participant Flow|Acalabrutinib + BSC + PPI|Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
11344979|NCT04497948|OG000|Outcome|Acalabrutinib + BSC + PPI, Visit 1 on Day 1|Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 1 on Day 1.
11344980|NCT04497948|OG001|Outcome|Acalabrutinib + BSC + PPI, Visit 2 on Day 2|Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 2 on Day 2.
11344981|NCT04497948|OG002|Outcome|Acalabrutinib + BSC + PPI, Visit 3 on Day 5|Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 3 on Day 5.
11344982|NCT04497948|OG000|Outcome|Acalabrutinib + BSC + PPI, Visit 1 on Day 1|Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
11344983|NCT04497948|OG002|Outcome|Acalabrutinib + BSC + PPI, Visit 3 on Day 5|Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment on visit 3 on Day 5.
11344984|NCT04497948|EG000|Reported Event|Acalabrutinib + BSC + PPI|Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
11344985|NCT04501640|BG000|Baseline|Mirabegron 25 mg Fed/Mirabegron 25 mg Fasted|Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
11344986|NCT04501640|BG001|Baseline|Mirabegron 25 mg Fasted/Mirabegron 25 mg Fed|Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
11344987|NCT04501640|BG002|Baseline|Mirabegron 50 mg Fed/Mirabegron 50 mg Fasted|Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
11344988|NCT04501640|BG003|Baseline|Mirabegron 50 mg Fasted/Mirabegron 50 mg Fed|Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
11344989|NCT04501640|BG004|Baseline|Total|Total of all reporting groups
11344990|NCT04501640|FG000|Participant Flow|Mirabegron 25 mg Fed/Mirabegron 25 mg Fasted|Participants received single dose of 25 milligrams (mg) mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
11344991|NCT04501640|FG001|Participant Flow|Mirabegron 25 mg Fasted/Mirabegron 25 mg Fed|Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
11344992|NCT04501640|FG002|Participant Flow|Mirabegron 50 mg Fed/Mirabegron 50 mg Fasted|Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
11344993|NCT04501640|FG003|Participant Flow|Mirabegron 50 mg Fasted/Mirabegron 50 mg Fed|Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
11344994|NCT04501640|OG000|Outcome|Mirabegron 25 mg Fed|Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
11344995|NCT04501640|OG001|Outcome|Mirabegron 25 mg Fasted|Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
11344996|NCT04501640|OG002|Outcome|Mirabegron 50 mg Fed|Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
11344997|NCT04501640|OG003|Outcome|Mirabegron 50 mg Fasted|Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
11344998|NCT04501640|EG000|Reported Event|Mirabegron 25 mg Fed|Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
11344999|NCT04501640|EG001|Reported Event|Mirabegron 25 mg Fasted|Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
11345000|NCT04501640|EG002|Reported Event|Mirabegron 50 mg Fed|Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
11345001|NCT04501640|EG003|Reported Event|Mirabegron 50 mg Fasted|Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
11345002|NCT04501952|BG000|Baseline|Remdesivir|Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
11345003|NCT04501952|BG001|Baseline|Placebo|Participants received IV PTM RDV on Days 1 to 3.
11345004|NCT04501952|BG002|Baseline|Total|Total of all reporting groups
11345005|NCT04501952|FG000|Participant Flow|Remdesivir (RDV)|Participants received a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
11345006|NCT04501952|FG001|Participant Flow|Placebo|Participants received IV placebo to match (PTM) RDV on Days 1 to 3.
11345007|NCT04501952|OG000|Outcome|Remdesivir|Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
11345008|NCT04501952|OG001|Outcome|Placebo|Participants received IV PTM RDV on Days 1 to 3.
11345009|NCT04501952|OG001|Outcome|Placebo|Participants received IV placebo to match RDV on Days 1 to 3.
11345010|NCT04501952|EG000|Reported Event|Remdesivir|Participants received a single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
11345011|NCT04501952|EG001|Reported Event|Placebo|Participants received IV PTM RDV on Days 1 to 3.
11345012|NCT04504032|BG000|Baseline|Rivaroxaban|Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
11345013|NCT04504032|BG001|Baseline|Placebo|Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
11345014|NCT04504032|BG002|Baseline|Total|Total of all reporting groups
11345015|NCT04504032|FG000|Participant Flow|Rivaroxaban|Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
11345016|NCT04504032|FG001|Participant Flow|Placebo|Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
11345017|NCT04504032|OG000|Outcome|Rivaroxaban|Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
11345018|NCT04504032|OG001|Outcome|Placebo|Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
11345019|NCT04504032|EG000|Reported Event|Rivaroxaban|Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
11345020|NCT04504032|EG001|Reported Event|Placebo|Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
11345021|NCT04507763|BG000|Baseline|Etanercept|Participants received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study.
11345022|NCT04507763|FG000|Participant Flow|Etanercept|Participants received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 milligrams [mg] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study.
11345023|NCT04507763|OG000|Outcome|Etanercept: Participants With Early Referral (<=1 Year)|Participants who were referred early (<=1 year after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
11345024|NCT04507763|OG001|Outcome|Etanercept: Participants With Delayed Referral (1.1 to 5 Years)|Participants who were referred delayed (1.1 to 5 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
11345025|NCT04507763|OG002|Outcome|Etanercept: Participants With Delayed Referral (5.1 to 10 Years)|Participants who were referred delayed (5.1 to 10 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
11345026|NCT04507763|OG003|Outcome|Etanercept: Participants With Delayed Referral (>10 Years)|Participants who were referred delayed (>10 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).. Data of these participants were studied for 2 months in this retrospective, observational study.
11345027|NCT04507763|EG000|Reported Event|Etanercept|Participants received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study.
11345028|NCT04507867|BG000|Baseline|Control Group|Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
11345029|NCT04507867|BG001|Baseline|Intervention Group|"Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.~Also it received the Nutritional support system (NSS), which consists of:~10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.~Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.~One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days."
11345030|NCT04507867|BG002|Baseline|Total|Total of all reporting groups
11345031|NCT04507867|FG000|Participant Flow|Control Group|Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
11345032|NCT04507867|FG001|Participant Flow|Intervention Group|"Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.~Also it received the Nutritional support system (NSS), which consists of:~10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.~Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.~One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days."
11345033|NCT04507867|OG000|Outcome|Control Group|Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
11345034|NCT04507867|OG001|Outcome|Intervention Group|"Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.~Also it received the Nutritional support system (NSS), which consists of:~10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.~Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.~One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days."
11345035|NCT04507867|OG000|Outcome|Control Group|"Patients who received the standard diet~Conventional nutritional support designed by hospital nutritionists: Diet designed by the nutrition department according to comorbidities and intubation probability. Food will be established according to the provisions of the ISSEMYM Toluca Arturo Montiel Rojas Medical Center."
11345036|NCT04507867|OG001|Outcome|Intervention Group|"Patients who received the nutritional support system (NSS) and the standard diet~Nutritional support system (NSS): 1.Combination of three B vitamins (B1, B6 and B12) Neurobion 10 mg solution for IM injection, One every 24 hours for the first 5 days.~2.Probiotics Saccharomyces boulardii CNCM I-745 Floratil. One morning and one evening 250 mg capsule during the first 6 days~3. One envelope of NSS-1 in the morning and one envelope in the afternoon mixed with 400 ml of water each, contain nutritional support system.~Conventional nutritional support designed by hospital nutritionists: Diet designed by the nutrition department according to comorbidities and intubation probability. Food will be established according to the provisions of the ISSEMYM Toluca Arturo Montiel Rojas Medical Center."
11345037|NCT04507867|OG000|Outcome|Fibrinogen <700 mg/dL|Patients with fibrinogen levels <700 mg/dl at baseline and died.
11345038|NCT04507867|OG001|Outcome|Fibrinogen >700 mg/dL|Patients with fibrinogen levels > 700 mg/dl at baseline and died.
11345039|NCT04507867|OG000|Outcome|Procalcitonin <0.5 ng/mL|Patients with procalcitonin levels <0.5 ng/mL at baseline and died.
11345040|NCT04507867|OG001|Outcome|Procalcitonin >0.5 ng/mL|Patients with procalcitonin levels >0.5 ng/mL at baseline and died.
11345041|NCT04507867|OG000|Outcome|Ureic Nitrogen <22 mg/dL|Patients with Ureic Nitrogen <22 mg/dL at baseline and died.
11345042|NCT04507867|OG001|Outcome|Ureic Nitrogen >22 mg/dL|Patients with Ureic Nitrogen >22 mg/dL at baseline and died.
11345043|NCT04507867|OG000|Outcome|RCP <150 mg/L|Patients with RCP <150 mg/L at baseline and died.
11345044|NCT04507867|OG001|Outcome|RCP >150 mg/L|Patients with RCP >150 mg/L at baseline and died.
11345045|NCT04507867|OG000|Outcome|Neutrophils <80%|Patients with neutrophils <80% at baseline and died
11345046|NCT04507867|OG001|Outcome|Neutrophils >80%|Patients with neutrophils >80% at baseline and died
11345047|NCT04507867|OG000|Outcome|Leukocytes <10x10^3/μL|Patients with Leukocytes <10x10^3/μL at baseline and died
11345048|NCT04507867|OG001|Outcome|Leukocytes >10x10^3/μL|Patients with Leukocytes >10x10^3/μL at baseline and died
11345049|NCT04507867|OG000|Outcome|Urea <40 mg/dL|Patients with Urea <40 mg/dL at baseline and died
11345050|NCT04507867|OG001|Outcome|Urea >40 mg/dL|Patients with Urea >40 mg/dL at baseline and died
11345051|NCT04507867|EG000|Reported Event|Control Group|Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
11345052|NCT04507867|EG001|Reported Event|Intervention Group|"Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.~Also it received the Nutritional support system (NSS), which consists of:~10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.~Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.~One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days."
11345053|NCT04525079|BG000|Baseline|CT-P59 10 mg/kg|Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345054|NCT04525079|BG001|Baseline|CT-P59 20 mg/kg|Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345055|NCT04525079|BG002|Baseline|CT-P59 40 mg/kg|Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345056|NCT04525079|BG003|Baseline|CT-P59 80 mg/kg|Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345057|NCT04525079|BG004|Baseline|Placebo|Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345058|NCT04525079|BG005|Baseline|Total|Total of all reporting groups
11345059|NCT04525079|FG000|Participant Flow|CT-P59 10 mg/kg|Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345060|NCT04525079|FG001|Participant Flow|CT-P59 20 mg/kg|Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345061|NCT04525079|FG002|Participant Flow|CT-P59 40 mg/kg|Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345062|NCT04525079|FG003|Participant Flow|CT-P59 80 mg/kg|Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345063|NCT04525079|FG004|Participant Flow|Placebo|Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345064|NCT04525079|OG000|Outcome|CT-P59 10 mg/kg|Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345065|NCT04525079|OG001|Outcome|CT-P59 20 mg/kg|Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345066|NCT04525079|OG002|Outcome|CT-P59 40 mg/kg|Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345067|NCT04525079|OG003|Outcome|CT-P59 80 mg/kg|Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345068|NCT04525079|OG004|Outcome|Placebo|Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345069|NCT04525079|EG000|Reported Event|CT-P59 10 mg/kg|Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345070|NCT04525079|EG001|Reported Event|CT-P59 20 mg/kg|Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345071|NCT04525079|EG002|Reported Event|CT-P59 40 mg/kg|Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345072|NCT04525079|EG003|Reported Event|CT-P59 80 mg/kg|Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345073|NCT04525079|EG004|Reported Event|Placebo|Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
11345074|NCT04527978|BG000|Baseline|PRECISION1, Then Biotrue ONEday|Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
11345075|NCT04527978|BG001|Baseline|Biotrue ONEday, Then PRECISION1|Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
11345076|NCT04527978|BG002|Baseline|Total|Total of all reporting groups
11345077|NCT04527978|FG000|Participant Flow|PRECISION1, Then Biotrue ONEday|Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
11345078|NCT04527978|FG001|Participant Flow|Biotrue ONEday, Then PRECISION1|Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
11345079|NCT04527978|OG000|Outcome|PRECISION1|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -0/+3 days in a daily disposable modality
11345080|NCT04527978|OG001|Outcome|Biotrue ONEday|Nesofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -0/+3 days in a daily disposable modality
11345081|NCT04527978|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
11345082|NCT04527978|EG001|Reported Event|PRECISION1 Ocular|Events reported in this group occurred while exposed to the verofilcon A contact lenses
11345083|NCT04527978|EG002|Reported Event|PRECISION1 Nonocular|Events reported in this group occurred while exposed to the verofilcon A contact lenses
11345084|NCT04527978|EG003|Reported Event|Biotrue ONEday Ocular|Events reported in this group occurred while exposed to the nesofilcon A contact lenses
11345085|NCT04527978|EG004|Reported Event|Biotrue ONEday Nonocular|Events reported in this group occurred while exposed to the nesofilcon A contact lenses
11345086|NCT04528017|BG000|Baseline|PRECISION1, Then Clariti 1-Day|Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
11345087|NCT04528017|BG001|Baseline|Clariti 1-Day, Then PRECISION1|Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
11345088|NCT04528017|BG002|Baseline|Total|Total of all reporting groups
11345089|NCT04528017|FG000|Participant Flow|PRECISION1, Then Clariti 1-Day|Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
11345090|NCT04528017|FG001|Participant Flow|Clariti 1-Day, Then PRECISION1|Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
11345091|NCT04528017|OG000|Outcome|PRECISION1|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -0/+3 days in a daily disposable modality
11345092|NCT04528017|OG001|Outcome|Clariti 1-Day|Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -0/+3 days in a daily disposable modality
11345093|NCT04528017|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
11345094|NCT04528017|EG001|Reported Event|PRECISION1 Ocular|Events reported in this group occurred while exposed to the verofilcon A contact lenses
11345095|NCT04528017|EG002|Reported Event|PRECISION1 Nonocular|Events reported in this group occurred while exposed to the verofilcon A contact lenses
11345096|NCT04528017|EG003|Reported Event|Clariti 1-Day Ocular|Events reported in this group occurred while exposed to the somofilcon A contact lenses
11345097|NCT04528017|EG004|Reported Event|Clariti 1-Day Nonocular|Events reported in this group occurred while exposed to the somofilcon A contact lenses
11345098|NCT04529109|BG000|Baseline|Total|All subjects who were dispensed a study lens.
11345099|NCT04529109|FG000|Participant Flow|Test/Control|Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1.
11345100|NCT04529109|FG001|Participant Flow|Control/Test|Subjects randomized to receive the Control lens during the first period and then received the Test lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1.
11345101|NCT04529109|OG000|Outcome|Test (Etafilcon A With Cosmetic Pattern)|Subjects that wore the Test lens in either the first or second period of the study.
11345102|NCT04529109|OG001|Outcome|Control (Etafilcon A With Cosmetic Pattern)|Subjects that wore the Control lens in either the first or second period of the study.
11345103|NCT04529109|EG000|Reported Event|Test (Etafilcon A With Cosmetic Pattern)|Subjects that wore the Test lens in either the first or second period of the study.
11345104|NCT04529109|EG001|Reported Event|Control (Etafilcon A With Cosmetic Pattern)|Subjects that wore the Control lens in either the first or second period of the study.
11345105|NCT04536571|BG000|Baseline|Overall Study|Subjects were randomized to wear either test or control lenses for 30 minutes and then cross-over to the other lens.
11345106|NCT04536571|FG000|Participant Flow|Test Contact Lens Then Control Contact Lens|Subjects were randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
11345107|NCT04536571|FG001|Participant Flow|Control Contact Lens Then Test Lens|Subjects were randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
11345108|NCT04536571|OG000|Outcome|Test Contact Lens|"Subjects were randomized to wear test lenses for 30 minutes.~Test Contact lens: contact lenses."
11345109|NCT04536571|OG001|Outcome|Control Contact Lens|"Subjects were randomized to wear control lenses for 30 minutes.~Control Contact lens: contact lenses."
11345110|NCT04536571|OG000|Outcome|Test Contact Lens - Right Eye|Subjects were randomized to wear test lenses - Toric Lens rotation was recorded at 10 minutes after dispense.
11345111|NCT04536571|OG001|Outcome|Test Contact Lens - Left Eye|Subjects were randomized to wear test lenses - Toric Lens rotation was recorded at 10 minutes after dispense.
11345112|NCT04536571|OG000|Outcome|Test Contact Lens|"Subjects were randomized to wear test contact lenses for 30 minutes.~Test Contact lens"
11345113|NCT04536571|OG001|Outcome|Control Contact Lenses|Subjects were randomized to wear control lenses for 30 minutes.
11345114|NCT04536571|EG000|Reported Event|Test Contact Lens|"Subjects were randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.~Test Contact lens: contact lenses."
11345115|NCT04536571|EG001|Reported Event|Control Contact Lens|"Subjects were randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.~Control Contact lens: contact lenses."
11345116|NCT04544787|BG000|Baseline|Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on study Day 0.
11345117|NCT04544787|BG001|Baseline|Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).
11345118|NCT04544787|BG002|Baseline|Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.
11345119|NCT04544787|BG003|Baseline|Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).
11345120|NCT04544787|BG004|Baseline|Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).
11345121|NCT04544787|BG005|Baseline|Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).
11345122|NCT04544787|BG006|Baseline|Group 7: IPV-vaccinated - Two Doses of Placebo|Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
11345123|NCT04544787|BG007|Baseline|Total|Total of all reporting groups
11345124|NCT04544787|FG000|Participant Flow|Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received one dose of novel oral polio vaccine type 2 (nOPV2) candidate 1 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ 50% cell culture infectious dose units [CCID50]).
11345125|NCT04544787|FG001|Participant Flow|Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11345126|NCT04544787|FG002|Participant Flow|Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11345127|NCT04544787|FG003|Participant Flow|Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11345128|NCT04544787|FG004|Participant Flow|Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11345129|NCT04544787|FG005|Participant Flow|Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11345130|NCT04544787|FG006|Participant Flow|Group 7: IPV-vaccinated - Two Doses of Placebo|Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total).
11345131|NCT04544787|OG000|Outcome|Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.
11345132|NCT04544787|OG001|Outcome|Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).
11345133|NCT04544787|OG002|Outcome|Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.
10855231|NCT00328016|EG000|Reported Event|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period during an experimental session on a subsequent day.
11345134|NCT04544787|OG003|Outcome|Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).
11345135|NCT04544787|OG004|Outcome|Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).
11345136|NCT04544787|OG005|Outcome|Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).
11345137|NCT04544787|OG006|Outcome|Group 7: IPV-vaccinated - Two Doses of Placebo|Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
11345138|NCT04544787|OG000|Outcome|Group 1+2: OPV-vaccinated - Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on study Day 0.
11345139|NCT04544787|OG001|Outcome|Group 3+4: OPV-vaccinated - Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.
11345140|NCT04544787|OG000|Outcome|Group 1+2: OPV-vaccinated - Novel OPV2 Candidate 1 Post-dose 1|Participants previously vaccinated with OPV received vaccination with novel OPV2 candidate 1 on study Day 0.
11345141|NCT04544787|OG001|Outcome|Group 2: OPV-vaccinated - Novel OPV2 Candidate 1 Post-dose 2|Participants previously vaccinated with OPV received a second vaccination with novel OPV2 candidate 1 on Day 28.
11345142|NCT04544787|OG002|Outcome|Group 3+4: OPV-vaccinated - Novel OPV2 Candidate 2 Post-dose 1|Participants previously vaccinated with OPV received vaccination with novel OPV2 candidate 2 on study Day 0.
11345143|NCT04544787|OG003|Outcome|Group 4: OPV-vaccinated - Novel OPV2 Candidate 2 Post-dose 2|Participants previously vaccinated with OPV received a second vaccination with novel OPV2 candidate 2 on Day 28.
11345144|NCT04544787|OG000|Outcome|Group 5: IPV-vaccinated - Novel OPV2 Candidate 1 Post-dose 1|Participants previously vaccinated with only IPV received a vaccination with novel OPV2 candidate 1 on Day 0.
11345145|NCT04544787|OG001|Outcome|Group 5: IPV-vaccinated - Novel OPV2 Candidate 1 Post-dose 2|Participants previously vaccinated with only IPV received a second vaccination with novel OPV2 candidate 1 on Day 28.
11345146|NCT04544787|OG002|Outcome|Group 6: IPV-vaccinated - Novel OPV2 Candidate 2 Post-dose 1|Participants previously vaccinated with only IPV received a vaccination with novel OPV2 candidate 2 on Day 0.
11345147|NCT04544787|OG003|Outcome|Group 6: IPV-vaccinated - Novel OPV2 Candidate 2 Post-dose 2|Participants previously vaccinated with only IPV received a second vaccination with novel OPV2 candidate 2 on Day 28.
11345148|NCT04544787|OG004|Outcome|Group 7: IPV-vaccinated - Placebo Post-dose 1|Participants previously vaccinated with only IPV received a vaccination with placebo on Day 0.
11345149|NCT04544787|OG005|Outcome|Group 7: IPV-vaccinated - Placebo Post-dose 2|Participants previously vaccinated with only IPV received a second vaccination with placebo on Day 28.
11345150|NCT04544787|OG000|Outcome|Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on study Day 0.
11345151|NCT04544787|OG000|Outcome|Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).
11345152|NCT04544787|OG001|Outcome|Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).
11345153|NCT04544787|OG002|Outcome|Group 7: IPV-vaccinated - Two Doses of Placebo|Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
11345154|NCT04544787|OG000|Outcome|Group 1+2: OPV-vaccinated - Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received a vaccination with novel OPV2 candidate 1 on study Day 0.
11345155|NCT04544787|OG001|Outcome|Group 3+4: OPV-vaccinated - Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received a vaccination with novel OPV2 candidate 2 on study Day 0.
11345156|NCT04544787|OG002|Outcome|Group 5: IPV-vaccinated - Novel OPV2 Candidate 1|Participants previously vaccinated with only IPV received a vaccination with novel OPV2 candidate 1 on Day 0.
11345157|NCT04544787|OG003|Outcome|Group 6: IPV-vaccinated - Novel OPV2 Candidate 2|Participants previously vaccinated with only IPV received a vaccination with novel OPV2 candidate 2 on Day 0.
11345158|NCT04544787|OG004|Outcome|Group 7: IPV-vaccinated - Placebo|Participants previously vaccinated with only IPV received a vaccination with placebo on Day 0.
11345159|NCT04544787|OG000|Outcome|Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).
11345160|NCT04544787|OG001|Outcome|Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).
11345161|NCT04544787|EG000|Reported Event|Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on study Day 0.
11345162|NCT04544787|EG001|Reported Event|Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).
11345163|NCT04544787|EG002|Reported Event|Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2|Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.
11345164|NCT04544787|EG003|Reported Event|Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).
11345165|NCT04544787|EG004|Reported Event|Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).
11345166|NCT04544787|EG005|Reported Event|Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2|Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).
11345167|NCT04544787|EG006|Reported Event|Group 7: IPV-vaccinated - Two Doses of Placebo|Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
11345168|NCT04555031|BG000|Baseline|All Participants|Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study, therefore each participant wore kalifilcon A lens, Dailies Total 1, Precision 1, and Biotrue ONEday. The only way to show demography for each lens is to show the same information for 10 participants that completed kalifilcon A lens wear, the 10 participants that completed Dailies Total 1 wear, the 10 participants that completed Precision 1 wear, and the 10 participants that completed Biotrue ONEday wear, but there are 10 participants total, not the 40 that the demography table would show if the duplicate information is entered for each lens to which a participant was exposed.
11345169|NCT04555031|FG000|Participant Flow|All Participants|Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each.
11345170|NCT04555031|OG000|Outcome|Kalifilcon A Lenses|kalifilcon A lenses: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
11345171|NCT04555031|OG001|Outcome|Dailies Total 1|Dalies Total 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
11345172|NCT04555031|OG002|Outcome|Precision 1|Precision 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
11345173|NCT04555031|OG003|Outcome|Biotrue ONEday|Biotrue ONEday: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
11345174|NCT04555031|EG000|Reported Event|All Participants|Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each. There are were 0 adverse events total in the 10 participants, therefore there were 0 AEs while each participant wore kalifilcon A lens, 0 AEs while each participant wore Dailies Total 1, 0 AEs while each participant wore Precision 1, and 0 AEs while each participant wore Biotrue ONEday. The same is true for serious AEs.
11345175|NCT04559282|BG000|Baseline|Entire Study Population|Crossover, participants received Baha 6 Max or Baha 5 SP followed by Baha 5 SP or Baha 6 Max followed by Unaided
11345176|NCT04559282|FG000|Participant Flow|Baha 6 Max Followed by Baha 5 SP Followed by Unaided Hearing|Participants received Baha 6 Max followed by Baha 5 SP followed by Unaided
11345177|NCT04559282|FG001|Participant Flow|Baha 5 SP Followed by Baha 6 Max Followed by Unaided Hearing|Participants received Baha 5 SP followed by Baha 6 Max followed by Unaided
11345178|NCT04559282|OG000|Outcome|Baha 6 Max|Baha 6 Max SP
11345179|NCT04559282|OG001|Outcome|Unaided|Unaided hearing
11345180|NCT04559282|OG001|Outcome|Baha 5|Baha 5 SP
11345181|NCT04559282|OG001|Outcome|Baha 5|Baha SP
11345182|NCT04559282|EG000|Reported Event|Baha 6 Max|Baha 6 Max SP
11345183|NCT04559282|EG001|Reported Event|Baha 5|Baha 5 SP
11345184|NCT04559282|EG002|Reported Event|Unaided|Unaided hearing
11345185|NCT04574297|BG000|Baseline|G+/E+ Group|Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
10976575|NCT00941070|BG000|Baseline|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
11345186|NCT04574297|BG001|Baseline|G-/E+ Group|Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345187|NCT04574297|BG002|Baseline|G+/E- Group|Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345188|NCT04574297|BG003|Baseline|G-/E- Group|Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345189|NCT04574297|BG004|Baseline|Total|Total of all reporting groups
11345190|NCT04574297|FG000|Participant Flow|G+/E+ Group|Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345191|NCT04574297|FG001|Participant Flow|G-/E+ Group|Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345192|NCT04574297|FG002|Participant Flow|G+/E- Group|Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345193|NCT04574297|FG003|Participant Flow|G-/E- Group|Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345194|NCT04574297|OG000|Outcome|G+/E+ Group|Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345195|NCT04574297|OG001|Outcome|G-/E+ Group|Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345196|NCT04574297|OG002|Outcome|G+/E- Group|Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345197|NCT04574297|OG003|Outcome|G-/E- Group|Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
11345198|NCT04574297|EG000|Reported Event|G+/E+ Group|"genetic factor/s positive and environmental factor/s positive group Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+).~Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+)."
11345199|NCT04574297|EG001|Reported Event|G-/E+ Group|"genetic factor/s negative and environmental factor/s positive group Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+).~Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+)."
11345200|NCT04574297|EG002|Reported Event|G+/E- Group|"genetic factor/s positive group and environmental factor/s negative Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+).~Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+)."
11345201|NCT04574297|EG003|Reported Event|G-/E- Group|genetic factor/s negative group and environmental factor/s negative
11345202|NCT04580290|BG000|Baseline|Jewel ACL Only|Subjects who received only the JewelACL
11345203|NCT04580290|BG001|Baseline|JewelACL + Autograft (Hybrid)|Subjects who received the JewelACL + Autograft (hybrid)
11345204|NCT04580290|BG002|Baseline|Total|Total of all reporting groups
11345205|NCT04580290|FG000|Participant Flow|JewelACL Only|Patients who received JewelACL only
11345206|NCT04580290|FG001|Participant Flow|JewelACL + Autograft (Hybrid)|Patients who received a JewelACL and autograft
11345207|NCT04580290|OG000|Outcome|JewelACL Only|Patients who received JewelACL only
11345208|NCT04580290|OG001|Outcome|JewelACL + Autograft (Hybrid)|Patients who received a JewelACL and autograft
11345209|NCT04580290|EG000|Reported Event|JewelACL Only|Patients who received JewelACL only
10855232|NCT00328016|EG001|Reported Event|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery.
10855233|NCT00328042|BG000|Baseline|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
10855234|NCT00328042|BG001|Baseline|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
10855235|NCT00328042|BG002|Baseline|Total|Total of all reporting groups
11345210|NCT04580290|EG001|Reported Event|JewelACL + Autograft (Hybrid)|Patients who received a JewelACL and autograft
11345211|NCT04601103|BG000|Baseline|Comparator: No SLS Toothpaste|"3M Oral Rinse in combination with no SLS toothpaste (A)~No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
10855236|NCT00328042|FG000|Participant Flow|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
11126299|NCT00915681|BG000|Baseline|Legalon SIL|"Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump~Silibinin: 20 mg/kg/day IV"
11126300|NCT00915681|FG000|Participant Flow|Legalon SIL|"Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump~Silibinin: 20 mg/kg/day IV"
11126301|NCT00915681|OG000|Outcome|Legalon SIL|"Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump~Silibinin: 20 mg/kg/day IV"
11126302|NCT00915681|EG000|Reported Event|Legalon SIL|"Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump~Silibinin: 20 mg/kg/day IV"
11126303|NCT00145158|BG000|Baseline|Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).
11126304|NCT00145158|BG001|Baseline|Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
11126305|NCT00145158|BG002|Baseline|Total|Total of all reporting groups
11126306|NCT00145158|FG000|Participant Flow|Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).
11126307|NCT00145158|FG001|Participant Flow|Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
11126308|NCT00145158|OG000|Outcome|Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).
11126309|NCT00145158|OG001|Outcome|Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
10855237|NCT00328042|FG001|Participant Flow|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
10855238|NCT00328042|OG000|Outcome|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
10855239|NCT00328042|OG001|Outcome|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
11222963|NCT02349685|OG002|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.~H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
11222964|NCT02349685|EG000|Reported Event|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
11222965|NCT02349685|EG001|Reported Event|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
11222966|NCT02349685|EG002|Reported Event|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
11222967|NCT02349711|BG000|Baseline|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
11222968|NCT02349711|BG001|Baseline|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
11222969|NCT02349711|BG002|Baseline|Total|Total of all reporting groups
11222970|NCT02349711|FG000|Participant Flow|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
11222971|NCT02349711|FG001|Participant Flow|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
11222972|NCT02349711|OG000|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
11222973|NCT02349711|OG001|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
11222974|NCT02349711|EG000|Reported Event|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
11222975|NCT02349711|EG001|Reported Event|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
11222976|NCT02349789|BG000|Baseline|Parkinson's Subjects|Participants with akinetic, rigid Parkinson's disease
11222977|NCT02349789|FG000|Participant Flow|Parkinson's Subjects|Participants with akinetic, rigid Parkinson's disease
11222978|NCT02349789|OG000|Outcome|Parkinson's Subjects|Participants with akinetic, rigid Parkinson's disease
11222979|NCT02349789|EG000|Reported Event|Parkinson's Subjects|Participants with akinetic, rigid Parkinson's disease
11222980|NCT02350127|BG000|Baseline|Immediate Start|The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
11222981|NCT02350127|BG001|Baseline|Delayed Start|Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
11222982|NCT02350127|BG002|Baseline|Total|Total of all reporting groups
10855240|NCT00328042|OG000|Outcome|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
11345212|NCT04601103|BG001|Baseline|Comparator: Medium SLS Toothpaste|"3M Oral Rinse in combination with medium SLS toothpaste (B)~Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345213|NCT04601103|BG002|Baseline|Comparator: High SLS Toothpaste|"3M Oral Rinse in combination with high SLS toothpaste (C)~High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345214|NCT04601103|BG003|Baseline|Total|Total of all reporting groups
11345215|NCT04601103|FG000|Participant Flow|Comparator: No SLS Toothpaste|"3M Oral Rinse in combination with no SLS toothpaste (A)~No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
10855241|NCT00328042|OG001|Outcome|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
11345216|NCT04601103|FG001|Participant Flow|Comparator: Medium SLS Toothpaste|"3M Oral Rinse in combination with medium SLS toothpaste (B)~Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
10855242|NCT00328042|EG000|Reported Event|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
11345217|NCT04601103|FG002|Participant Flow|Comparator: High SLS Toothpaste|"3M Oral Rinse in combination with high SLS toothpaste (C)~High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345218|NCT04601103|OG000|Outcome|Comparator: No SLS Toothpaste|"3M Oral Rinse in combination with no SLS toothpaste (A)~No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345219|NCT04601103|OG001|Outcome|Comparator: Medium SLS Toothpaste|"3M Oral Rinse in combination with medium SLS toothpaste (B)~Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345220|NCT04601103|OG002|Outcome|Comparator: High SLS Toothpaste|"3M Oral Rinse in combination with high SLS toothpaste (C)~High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345221|NCT04601103|EG000|Reported Event|Comparator: No SLS Toothpaste|"3M Oral Rinse in combination with no SLS toothpaste (A)~No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345222|NCT04601103|EG001|Reported Event|Comparator: Medium SLS Toothpaste|"3M Oral Rinse in combination with medium SLS toothpaste (B)~Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345223|NCT04601103|EG002|Reported Event|Comparator: High SLS Toothpaste|"3M Oral Rinse in combination with high SLS toothpaste (C)~High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate~Anti-plaque: Rinse prevents bacterial adherence to teeth"
11345224|NCT04617574|BG000|Baseline|AEON Endostapler|"Stapling performed with AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
10855243|NCT00328042|EG001|Reported Event|Information-Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
11345225|NCT04617574|BG001|Baseline|Endo GIA Reloads With Tri-Staple Technology|"Stapling performed with Endo GIA Reloads with Tri-Staple Technology~Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology"
11345226|NCT04617574|BG002|Baseline|Total|Total of all reporting groups
11345227|NCT04617574|FG000|Participant Flow|AEON Endostapler|"Stapling performed with AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
11345228|NCT04617574|FG001|Participant Flow|Endo GIA Reloads With Tri-Staple Technology|"Stapling performed with Endo GIA Reloads with Tri-Staple Technology~Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology"
11345229|NCT04617574|OG000|Outcome|AEON Endostapler|"Stapling performed with AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
11345230|NCT04617574|OG001|Outcome|Endo GIA Reloads With Tri-Staple Technology|"Stapling performed with Endo GIA Reloads with Tri-Staple Technology~Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology"
11345231|NCT04617574|EG000|Reported Event|AEON Endostapler|"Stapling performed with AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
11345232|NCT04617574|EG001|Reported Event|Endo GIA Reloads With Tri-Staple Technology|"Stapling performed with Endo GIA Reloads with Tri-Staple Technology~Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology"
11345233|NCT04658797|BG000|Baseline|Single Vision Spectacle for Vision Correction|Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
11345234|NCT04658797|BG001|Baseline|Somofilcon A Daily Disposable Contact Lenses|Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.
11345235|NCT04658797|BG002|Baseline|Total|Total of all reporting groups
11345236|NCT04658797|FG000|Participant Flow|Single Vision Spectacle for Vision Correction|Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
11345237|NCT04658797|FG001|Participant Flow|Somofilcon A Daily Disposable Contact Lenses|Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.
11345238|NCT04658797|OG000|Outcome|Somofilcon A Daily Disposable Contact Lenses|Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.
11345239|NCT04658797|OG001|Outcome|Single Vision Spectacle for Vision Correction|Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
11345240|NCT04658797|EG000|Reported Event|Single Vision Spectacle for Vision Correction|Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
11345241|NCT04658797|EG001|Reported Event|Somofilcon A Daily Disposable Contact Lenses|Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.
11345242|NCT04664855|BG000|Baseline|Experimental Yoga Group|"23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school~Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session"
11345243|NCT04664855|BG001|Baseline|Control Group (No Yoga Intervention)|22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
11345244|NCT04664855|BG002|Baseline|Total|Total of all reporting groups
11345245|NCT04664855|FG000|Participant Flow|Experimental Yoga Group|"23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school~Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session"
11345246|NCT04664855|FG001|Participant Flow|Control Group (No Yoga Intervention)|22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
11345247|NCT04664855|OG000|Outcome|Experimental Yoga Group|"23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school~Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session"
11345248|NCT04664855|OG001|Outcome|Control Group (No Yoga Intervention)|22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
11345249|NCT04664855|EG000|Reported Event|Experimental Yoga Group|"23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school~Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session"
11345250|NCT04664855|EG001|Reported Event|Control Group (No Yoga Intervention)|22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
10855244|NCT00328094|BG000|Baseline|Continuous Insulin Infusion|Tight glucose group with insulin infusion
10855245|NCT00328094|BG001|Baseline|Intermittent Insulin Bolus|Intermittent insulin boluses group
10855246|NCT00328094|BG002|Baseline|Total|Total of all reporting groups
10855247|NCT00328094|FG000|Participant Flow|Continuous Insulin Infusion|Tight glucose group with insulin infusion
10855248|NCT00328094|FG001|Participant Flow|Intermittent Insulin Bolus|Intermittent insulin boluses group
10855249|NCT00328094|OG000|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
10855250|NCT00328094|OG001|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
10855251|NCT00328094|EG000|Reported Event|Continuous Insulin Infusion|Tight glucose group with insulin infusion
10855252|NCT00328094|EG001|Reported Event|Intermittent Insulin Bolus|Intermittent insulin boluses group
10855253|NCT00328172|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
10855254|NCT00328172|BG001|Baseline|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
10855255|NCT00328172|BG002|Baseline|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
10855256|NCT00328172|BG003|Baseline|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
10855257|NCT00328172|BG004|Baseline|Metformin|Patients randomized to receive treatment with metformin
10855258|NCT00328172|BG005|Baseline|Total|Total of all reporting groups
10855259|NCT00328172|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
10855260|NCT00328172|FG001|Participant Flow|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
10855261|NCT00328172|FG002|Participant Flow|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
10855262|NCT00328172|FG003|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
10855263|NCT00328172|FG004|Participant Flow|Metformin|Patients randomized to receive treatment with metformin
10855264|NCT00328172|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
10855265|NCT00328172|OG001|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
10855266|NCT00328172|OG002|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
10855267|NCT00328172|OG003|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
10855268|NCT00328172|OG004|Outcome|Metformin|Patients randomized to receive treatment with metformin
10855269|NCT00328172|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
10855270|NCT00328172|EG001|Reported Event|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
11345251|NCT04701658|BG000|Baseline|Bamlanivimab 700 mg|Participants received 700 mg single IV infusion of Bamlanivimab.
11345252|NCT04701658|FG000|Participant Flow|Bamlanivimab 700 Milligram (mg)|Participants received 700 mg single intravenous (IV) infusion of Bamlanivimab.
11345253|NCT04701658|OG000|Outcome|Bamlanivimab 700 mg|Participants received 700 mg single IV infusion of Bamlanivimab.
11345254|NCT04701658|EG000|Reported Event|Bamlanivimab 700 mg|Participants received 700 mg single IV infusion of Bamlanivimab.
11345255|NCT04706416|BG000|Baseline|N-Acetyl Glucosamine|"All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).~N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care."
11345256|NCT04706416|BG001|Baseline|Control|All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
11345257|NCT04706416|BG002|Baseline|Total|Total of all reporting groups
11345258|NCT04706416|FG000|Participant Flow|N-Acetyl Glucosamine|"All patients in the prospective arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).~N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care."
11345259|NCT04706416|FG001|Participant Flow|Control|All patients in the retrospective arm of the study were admitted to the same hospital for coronavirus disease 2019 (COVID-19), but they were not treated with the study treatment (N-Acetyl Glucosamine).
11345260|NCT04706416|OG000|Outcome|N-Acetyl Glucosamine|"All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).~N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care."
11345261|NCT04706416|OG001|Outcome|Control|All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
11345262|NCT04706416|OG000|Outcome|N-Acetyl Glucosamine|"All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).~10 treatment patients were admitted to the ICU and had ICU LOS data available."
11345263|NCT04706416|OG001|Outcome|Control|"All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).~36 control patients were admitted to the ICU and had ICU LOS data available."
11345264|NCT04706416|OG000|Outcome|N-Acetyl Glucosamine|All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
11345265|NCT04706416|EG000|Reported Event|N-Acetyl Glucosamine|"All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).~N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care."
11345266|NCT04706416|EG001|Reported Event|Control|All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
11345267|NCT04709484|BG000|Baseline|USG-guided Steroid Injection Group|"In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.~USG-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone."
11345268|NCT04709484|BG001|Baseline|Palpation-guided Steroid Injection Group|"In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.~Palpation-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone."
11345269|NCT04709484|BG002|Baseline|Total|Total of all reporting groups
11345270|NCT04709484|FG000|Participant Flow|USG-guided Steroid Injection Group|"In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.~USG-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone."
11345271|NCT04709484|FG001|Participant Flow|Palpation-guided Steroid Injection Group|"In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.~Palpation-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone."
11345272|NCT04709484|OG000|Outcome|USG-guided Steroid Injection Group|"In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.~USG-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone."
11345273|NCT04709484|OG001|Outcome|Palpation-guided Steroid Injection Group|"In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.~Palpation-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone."
11345274|NCT04709484|EG000|Reported Event|USG-guided Steroid Injection Group|"In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.~USG-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone."
11345275|NCT04709484|EG001|Reported Event|Palpation-guided Steroid Injection Group|"In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.~Palpation-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone."
11345276|NCT04727749|BG000|Baseline|Therapy Dog Team Visit|"Patient interacts with the therapy dog and handler.~Therapy Dog Team Visit: For the intervention group, patient interacts with the therapy dog, handler shares information about the therapy dog, asks about patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit."
11345277|NCT04727749|BG001|Baseline|No Therapy Dog Team Visit|No patient interaction with the therapy dog or handler.
11345278|NCT04727749|BG002|Baseline|Total|Total of all reporting groups
11345279|NCT04727749|FG000|Participant Flow|Therapy Dog Team Visit|"Patient interacts with the therapy dog and handler.~Therapy Dog Team Visit: For the intervention group, patient interacts with the therapy dog, handler shares information about the therapy dog, asks about patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit."
11345280|NCT04727749|FG001|Participant Flow|No Therapy Dog Team Visit|No patient interaction with the therapy dog or handler.
11345281|NCT04727749|OG000|Outcome|Therapy Dog Team Visit|"Patient interacts with the therapy dog and handler.~Therapy Dog Team Visit: For the intervention group, patient interacts with the therapy dog, handler shares information about the therapy dog, asks about patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit."
11345282|NCT04727749|OG001|Outcome|No Therapy Dog Team Visit|No patient interaction with the therapy dog or handler.
11345283|NCT04727749|OG000|Outcome|Therapy Dog Team Visit|Patient interacts with the therapy dog and handler.
11345284|NCT04727749|OG000|Outcome|Therapy Dog Team Visit|Patient interacts with the therapy dog and handler. Therapy Dog Team Visit: For the intervention group, the patient interacts with the therapy dog, the handler shares information about the therapy dog, asks about the patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit.
11345285|NCT04727749|EG000|Reported Event|Therapy Dog Team Visit|"Patient interacts with the therapy dog and handler.~Therapy Dog Team Visit: For the intervention group, patient interacts with the therapy dog, handler shares information about the therapy dog, asks about patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit."
11345286|NCT04727749|EG001|Reported Event|No Therapy Dog Team Visit|No patient interaction with the therapy dog or handler.
11345287|NCT04777214|BG000|Baseline|Active TMS|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.~Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold"
11345288|NCT04777214|BG001|Baseline|Sham TMS|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.~Sham TMS: Sham TMS will be administered"
11345289|NCT04777214|BG002|Baseline|Total|Total of all reporting groups
11345290|NCT04777214|FG000|Participant Flow|Active TMS|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.~Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold"
11345291|NCT04777214|FG001|Participant Flow|Sham TMS|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.~Sham TMS: Sham TMS will be administered~at least 2 months later, patients then receive Active TMS if they so choose. There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.~Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold"
11345292|NCT04777214|OG000|Outcome|Active TMS 2-month Follow-Up|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.~Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold~Outcome measures are then assessed 2 months after TMS treatment sessions."
11345293|NCT04777214|OG001|Outcome|Active TMS 6-month Follow-Up|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.~Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold~Outcome measures are then assessed 6 months after TMS treatment sessions."
11345294|NCT04777214|OG000|Outcome|Active TMS|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.~Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold"
11345295|NCT04777214|OG001|Outcome|Sham TMS|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.~Sham TMS: Sham TMS will be administered"
11345296|NCT04777214|EG000|Reported Event|Active TMS|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.~Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold"
11345297|NCT04777214|EG001|Reported Event|Sham TMS|"There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.~Sham TMS: Sham TMS will be administered"
11345298|NCT04854707|BG000|Baseline|Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH|"The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS.~Follicle Stimulating Hormone/Luteinizing Hormone: Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH."
11345299|NCT04854707|BG001|Baseline|Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH|"The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression."
11345300|NCT04854707|BG002|Baseline|Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH|"The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression."
11345301|NCT04854707|BG003|Baseline|Total|Total of all reporting groups
11345302|NCT04854707|FG000|Participant Flow|Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH|"The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS.~Follicle Stimulating Hormone/Luteinizing Hormone: Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH."
11345303|NCT04854707|FG001|Participant Flow|Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH|"The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression."
11345304|NCT04854707|FG002|Participant Flow|Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH|"The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression."
11345305|NCT04854707|OG000|Outcome|Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH|"The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS.~Follicle Stimulating Hormone/Luteinizing Hormone: Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH.~Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) in 78 participants (or 3%), the analysed population was 2547 participants."
11345306|NCT04854707|OG001|Outcome|Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH|"The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH.~Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) in 89 participants (or 3,1%), the analysed population was 2770 participants."
11345307|NCT04854707|OG002|Outcome|Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH|"The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression.~Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) in 59 participants (or 2,7%), the analysed population was 2124 participants."
11345308|NCT04854707|OG003|Outcome|Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH|"The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression.~Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) in 30 participants (or 4,4%), the analysed population was 646 participants."
11345309|NCT04854707|OG004|Outcome|The Overall Protocols|"The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH~Follicle Stimulating Hormone/Luteinizing Hormone: Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH)."
11345310|NCT04854707|OG000|Outcome|Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH|"The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS.~Follicle Stimulating Hormone/Luteinizing Hormone: Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH."
11345311|NCT04854707|OG001|Outcome|Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH|"The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH."
11345312|NCT04854707|OG002|Outcome|Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH|"The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression."
11345313|NCT04854707|OG003|Outcome|Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH|"The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH.~Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression."
11345314|NCT04854707|EG000|Reported Event|The Overall Protocols|"The overall protocols (groups) were combined and analysed for Serious Adverse Events and other (not including serious) adverse events.~Due to overall ovarian stimulation protocols consist of follitropin alpha biosimilar treatment for at least 5 days, the adverse events were combined in one group to analyse the safety of follitropin alpha biosimilar treatment not in relation to protocol of ovarian stimulation and other medication."
11345315|NCT04898166|BG000|Baseline|220 Hospitalized Male Participants Diagnosed Case of COVID-19.|220 hospitalized male Participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345316|NCT04898166|BG001|Baseline|80 Hospitalized Female Participants Diagnosed Case of COVID-19|80 hospitalized female Participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345317|NCT04898166|BG002|Baseline|Total|Total of all reporting groups
11345318|NCT04898166|FG000|Participant Flow|220 Hospitalized Male Participants Diagnosed Case of COVID-19.|220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345319|NCT04898166|FG001|Participant Flow|80 Hospitalized Female Participants Diagnosed Case of COVID-19.|80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345320|NCT04898166|OG000|Outcome|220 Hospitalized Participants Diagnosed Case of COVID-19.|220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345321|NCT04898166|OG001|Outcome|80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19|80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345322|NCT04898166|OG000|Outcome|220 Hospitalised Male Participants Diagnosed Case of COVID-19.|220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345323|NCT04898166|OG001|Outcome|80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19.|80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death
11345324|NCT04898166|OG000|Outcome|300 Participants Diagnosed Case of Hospitalized COVID-19. Mean Age be Noted|300 Participants diagnosed case of hospitalized COVID-19. Mean age be noted in both males and females
11345325|NCT04898166|OG000|Outcome|220 Hospitalised Male Subjects. Their Disease Outcomes in Relation to Severity of AGA|220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of Androgenetic alopecia be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. Their disease outcomes in relation to severity of AGA
11345326|NCT04898166|OG000|Outcome|80 Hospitalised Female Participants. Their Disease Outcomes in Relation to Severity of AGA|80 hospitalised female participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. Their disease outcomes in relation to severity of AGA
11345327|NCT04898166|OG000|Outcome|37 Hospitalised Female Participants of COVID-19 With Androgenetic Alopecia|37 hospitalised female participants diagnosed case of COVID-19 presence of absence of androgenetic alopecia influencing outcome be noted as patient on mask/bag, nasal cannula, ventilator or death with respec to aget
11345328|NCT04898166|OG001|Outcome|43 Hospitalised Female Participants of COVID-19 Without Androgenetic Alopecia With Respect to Age|43 hospitalised female participants diagnosed case of COVID-19 with androgenetic alopecia. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death with respect to age
11345329|NCT04898166|OG000|Outcome|43 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS <3.|43 hospitalised male participants diagnosed case of COVID-19 with HNS <3. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death with respect to age
10855271|NCT00328172|EG002|Reported Event|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
10855272|NCT00328172|EG003|Reported Event|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
10855273|NCT00328172|EG004|Reported Event|Metformin|Patients randomized to receive treatment with metformin
11345330|NCT04898166|OG001|Outcome|177 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS >3-7|177 hospitalised male participants diagnosed case of COVID-19 with HNS 3-7. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death with respect to age
11345331|NCT04898166|OG000|Outcome|220 Hospitalized Participants Diagnosed Case of COVID-19.|220 hospitalised male participants diagnosed case of COVID-19. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345332|NCT04898166|OG001|Outcome|80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19|80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345333|NCT04898166|OG000|Outcome|300 Participants Diagnosed Case of Hospitalized COVID-19 Outcome in Relation to Comorbidities|300 Participants diagnosed case of hospitalized COVID-19. 220 males and 80 females. Presence or absence of comorbidities. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345334|NCT04898166|OG000|Outcome|300 Participants Diagnosed Case of Hospitalized COVID-19 Disease Duration|300 Participants diagnosed case of hospitalized COVID-19 mean and standard deviation of disease duration.
11345335|NCT04898166|EG000|Reported Event|300 Participants Diagnosed Case of Hospitalized COVID-19 With or Without Androgenetic Alopecia.|300 Participants diagnosed case of hospitalized COVID-19. 220 males and 80 females. Presence or absence of androgenetic alopecia be noted in males and females. Severity of androgeneic throught be noted throught Hamilton norwood score and ludwig score, respectively. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death.
11345336|NCT04926233|BG000|Baseline|US IBM Marketscan - Overall|All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).
11345337|NCT04926233|BG001|Baseline|UK CPRD GOLD - Overall|All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
11345338|NCT04926233|BG002|Baseline|Total|Total of all reporting groups
11222983|NCT02350127|FG000|Participant Flow|Immediate Start|The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
11345339|NCT04926233|FG000|Participant Flow|US IBM Marketscan - Overall|All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).
11345340|NCT04926233|FG001|Participant Flow|UK CPRD GOLD - Overall|All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
11345341|NCT04926233|OG000|Outcome|US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval|"Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).~Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group."
11345342|NCT04926233|OG001|Outcome|US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval|"Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).~Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group."
11345343|NCT04926233|OG000|Outcome|UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval|"Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).~Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group."
11345344|NCT04926233|OG001|Outcome|UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval|"Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).~Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group."
11345345|NCT04926233|OG000|Outcome|US IBM Marketscan - Overall|All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).
11345346|NCT04926233|OG001|Outcome|US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval|"Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).~Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group."
11345347|NCT04926233|OG002|Outcome|US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval|"Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).~Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group."
11345348|NCT04926233|OG003|Outcome|UK CPRD GOLD - Overall|All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
11345349|NCT04926233|OG004|Outcome|UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval|"Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).~Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group."
11345350|NCT04926233|OG005|Outcome|UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval|"Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).~Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group."
11345351|NCT04926233|OG000|Outcome|US IBM Marketscan - 1MT - Overall|All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.
11345352|NCT04926233|OG001|Outcome|US IBM Marketscan - 1MT - ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Inhaled Corticosteroid (ICS) were included in this group."
11345353|NCT04926233|OG002|Outcome|US IBM Marketscan - 1MT - LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group."
11345354|NCT04926233|OG003|Outcome|US IBM Marketscan - 1MT - LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group."
11345355|NCT04926233|OG004|Outcome|US IBM Marketscan - 1MT - LAMA+LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group."
11345356|NCT04926233|OG005|Outcome|US IBM Marketscan - 1MT - LAMA+LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group."
11345357|NCT04926233|OG006|Outcome|US IBM Marketscan - 1MT - LAMA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group."
11345358|NCT04926233|OG007|Outcome|US IBM Marketscan - 1MT - LAMA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group"
11345359|NCT04926233|OG007|Outcome|US IBM Marketscan - 1MT - LAMA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group."
11345360|NCT04926233|OG000|Outcome|UK CPRD GOLD - 1MT - Overall|All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.
11345361|NCT04926233|OG001|Outcome|UK CPRD GOLD - 1MT - ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Inhaled Corticosteroid (ICS) were included in this group."
11345362|NCT04926233|OG002|Outcome|UK CPRD GOLD - 1MT - LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group."
11345363|NCT04926233|OG003|Outcome|UK CPRD GOLD - 1MT - LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group."
11345364|NCT04926233|OG004|Outcome|UK CPRD GOLD - 1MT - LAMA+LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group."
11345365|NCT04926233|OG005|Outcome|UK CPRD GOLD - 1MT - LAMA+LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group."
11345366|NCT04926233|OG006|Outcome|UK CPRD GOLD - 1MT - LAMA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group."
11345367|NCT04926233|OG007|Outcome|UK CPRD GOLD - 1MT - LAMA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group."
11345368|NCT04926233|OG000|Outcome|US IBM Marketscan - 2MT - Overall|All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.
11345369|NCT04926233|OG001|Outcome|US IBM Marketscan - 2MT - ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Inhaled Corticosteroid (ICS) were included in this group."
11345370|NCT04926233|OG002|Outcome|US IBM Marketscan - 2MT - LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group."
11345371|NCT04926233|OG003|Outcome|US IBM Marketscan - 2MT - LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group."
11345372|NCT04926233|OG004|Outcome|US IBM Marketscan - 2MT - LAMA+LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists(LAMA+LABA) were included in this group."
11345373|NCT04926233|OG005|Outcome|US IBM Marketscan - 2MT - LAMA+LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group."
11345374|NCT04926233|OG006|Outcome|US IBM Marketscan - 2MT - LAMA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group."
11345375|NCT04926233|OG007|Outcome|US IBM Marketscan - 2MT - LAMA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group."
11345376|NCT04926233|OG000|Outcome|UK CPRD GOLD - 2MT - Overall|All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy.
11345377|NCT04926233|OG001|Outcome|UK CPRD GOLD - 2MT - ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Inhaled Corticosteroid (ICS) were included in this group."
11345378|NCT04926233|OG002|Outcome|UK CPRD GOLD - 2MT - LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group."
11345379|NCT04926233|OG003|Outcome|UK CPRD GOLD - 2MT - LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group."
11345380|NCT04926233|OG004|Outcome|UK CPRD GOLD - 2MT - LAMA+LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group."
11345381|NCT04926233|OG005|Outcome|UK CPRD GOLD - 2MT - LAMA+LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group."
11345382|NCT04926233|OG006|Outcome|UK CPRD GOLD - 2MT - LAMA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group."
11345383|NCT04926233|OG007|Outcome|UK CPRD GOLD - 2MT - LAMA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group."
11345384|NCT04926233|OG001|Outcome|US IBM Marketscan - 2MT - ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Inhaled Corticosteroid (ICS) were included in this group."
11345385|NCT04926233|OG002|Outcome|US IBM Marketscan - 2MT - LABA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group."
11345386|NCT04926233|OG003|Outcome|US IBM Marketscan - 2MT - LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group."
11345387|NCT04926233|OG005|Outcome|US IBM Marketscan - 2MT - LAMA+LABA+ICS|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group."
11345388|NCT04926233|OG006|Outcome|US IBM Marketscan - 2MT - LAMA|"All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.~Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group."
11345389|NCT04926233|EG000|Reported Event|US IBM Marketscan - Overall|All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).
11345390|NCT04926233|EG001|Reported Event|UK CPRD GOLD - Overall|All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
11345391|NCT04943159|BG000|Baseline|Afamelanotide (Pooled Analysis)|"Group A are administered afamelanotide implant on Days 0, 21 and 42;~Group B are administered afamelanotide implant on Days 0 and 28."
11345392|NCT04943159|FG000|Participant Flow|Afamelanotide (Pooled Analysis)|"Group A are administered afamelanotide implant on Days 0, 21 and 42;~Group B are administered afamelanotide implant on Days 0 and 28."
11345393|NCT04943159|OG000|Outcome|Afamelanotide (Pooled Analysis)|"Group A are administered afamelanotide implant on Days 0, 21 and 42;~Group B are administered afamelanotide implant on Days 0 and 28."
11345394|NCT04943159|EG000|Reported Event|Afamelanotide (Pooled Analysis)|"Group A are administered afamelanotide implant on Days 0, 21 and 42;~Group B are administered afamelanotide implant on Days 0 and 28."
11345395|NCT04947436|BG000|Baseline|High Frequency Chest Wall Oscillation|High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.
11345396|NCT04947436|BG001|Baseline|High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation|"High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.~Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions."
11345397|NCT04947436|BG002|Baseline|Mechanical Insufflation/ Exsufflation|Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
11345398|NCT04947436|BG003|Baseline|Total|Total of all reporting groups
11345399|NCT04947436|FG000|Participant Flow|High Frequency Chest Wall Oscillation|High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.
11345400|NCT04947436|FG001|Participant Flow|Mechanical Insufflation/ Exsufflation|Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
11345401|NCT04947436|FG002|Participant Flow|High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation|"High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.~Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions."
11345402|NCT04947436|OG000|Outcome|High Frequency Chest Wall Oscillation|High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.
11345403|NCT04947436|OG001|Outcome|Mechanical Insufflation/ Exsufflation|Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
11345404|NCT04947436|OG002|Outcome|High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation|"High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.~Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions."
11345405|NCT04947436|EG000|Reported Event|High Frequency Chest Wall Oscillation|High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.
11345406|NCT04947436|EG001|Reported Event|Mechanical Insufflation/ Exsufflation|Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
11345407|NCT04947436|EG002|Reported Event|High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation|"High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.~Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions."
11345408|NCT05002972|BG000|Baseline|Walking Group|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11345409|NCT05002972|FG000|Participant Flow|Walking Group|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11345410|NCT05002972|OG000|Outcome|Walking Group|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11345411|NCT05002972|EG000|Reported Event|Walking Group|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11345412|NCT05002985|BG000|Baseline|Walking Group|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11345413|NCT05002985|FG000|Participant Flow|Walking Group|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11345414|NCT05002985|OG000|Outcome|Walking Group|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11345415|NCT05002985|EG000|Reported Event|Walking Group|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11345416|NCT04512482|BG000|Baseline|Placebo & Bromelain|"Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar (placebo) that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.~Subjects then had a 1 week (5-9 day) washout period and were then exposed to the other intervention (bromelain rinse)."
11345417|NCT04512482|BG001|Baseline|Bromelain & Placebo|"Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.~Subjects then had a 1 week (5-9 day) washout period and were then exposed to the other intervention (placebo rinse)."
11345418|NCT04512482|BG002|Baseline|Total|Total of all reporting groups
11345419|NCT04512482|FG000|Participant Flow|Placebo & Bromelain|"Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.~Subjects completed a 1 week (5-9 day) washout period and then completed the protocol again but received the bromelain rinse."
11345420|NCT04512482|FG001|Participant Flow|Bromelain & Placebo|"Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.~Subjects completed a 1 week (5-9 day) washout period and then completed the protocol again but received the placebo (powdered sugar)."
11345421|NCT04512482|OG000|Outcome|Bromelain|"Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.~Bromelain: The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention."
11345422|NCT04512482|OG001|Outcome|Placebo|"Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.~Powdered sugar: The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention."
11345423|NCT04512482|EG000|Reported Event|Bromelain|"Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.~Bromelain: The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention."
10855274|NCT00328198|BG000|Baseline|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
11345424|NCT04512482|EG001|Reported Event|Placebo|"Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.~Powdered sugar: The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention."
11345425|NCT04499599|BG000|Baseline|Fast Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours."
11345426|NCT04499599|BG001|Baseline|Breakfast Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.~Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group)."
11345427|NCT04499599|BG002|Baseline|Fast Bar Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.~Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group)."
11345428|NCT04499599|BG003|Baseline|Total|Total of all reporting groups
11345429|NCT04499599|FG000|Participant Flow|Fast Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours."
11345430|NCT04499599|FG001|Participant Flow|Breakfast Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.~Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group)."
11345431|NCT04499599|FG002|Participant Flow|Fast Bar Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.~Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group)."
11345432|NCT04499599|OG000|Outcome|Fast Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours."
11345433|NCT04499599|OG001|Outcome|Breakfast Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.~Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group)."
10845402|NCT00266864|EG000|Reported Event|Testosterone Replacement Therapy|A prospective, open-label, controlled drug intervention trial was performed in healthy hypogonadal and eugonadal outpatient men with chronic spinal cord injury (Treatment: serum testosterone concentration <4.0 mg/dL and Control: serum testosterone concentration ≥4.0 mg/dL). Treatment subjects received a transdermal testosterone patch (5 or 10 mg; Androderm, Watson Pharma Inc.) daily for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range. Only outcome measures were assessed for the no intervention arm; no adverse events were collected.
11345434|NCT04499599|OG002|Outcome|Fast Bar Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.~Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group)."
11345435|NCT04499599|EG000|Reported Event|Fast Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours."
11345436|NCT04499599|EG001|Reported Event|Breakfast Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.~Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group)."
11345437|NCT04499599|EG002|Reported Event|Fast Bar Group|"Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.~Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.~Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.~Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group)."
11345438|NCT04525157|BG000|Baseline|Afamelanotide and NB-UVB (Pooled Analysis)|The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.
11345439|NCT04525157|FG000|Participant Flow|Afamelanotide and NB-UVB (Pooled Analysis)|The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.
11345440|NCT04525157|OG000|Outcome|Afamelanotide and NB-UVB (Pooled Analysis)|The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.
11345441|NCT04525157|EG000|Reported Event|Afamelanotide and NB-UVB (Pooled Analysis)|The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.
11345442|NCT04523831|BG000|Baseline|Ivermectin and Doxycycline|"Ivermactin 6 mg 2 tab stat, cap Doxycycline 100 mg 1 cap BD 5 days~Ivermectin and Doxycycline: Ivermectin 6 mg stat and Doxycycline 100 mg twice daily for 5 days"
11345443|NCT04523831|BG001|Baseline|Placebo|Standard treatment
11345444|NCT04523831|BG002|Baseline|Total|Total of all reporting groups
11345445|NCT04523831|FG000|Participant Flow|Ivermectin and Doxycycline|"Ivermactin 6 mg 2 tab stat, cap Doxycycline 100 mg 1 cap BD 5 days~Ivermectin and Doxycycline: Ivermectin 6 mg stat and Doxycycline 100 mg twice daily for 5 days"
11345446|NCT04523831|FG001|Participant Flow|Placebo|Standard treatment
11345447|NCT04523831|OG000|Outcome|Ivermectin Plus Doxycycline|Ivermectin plus Doxycycline plus Standard of care
11345448|NCT04523831|OG001|Outcome|Placebo|Placebo plus Standard of care
11345449|NCT04523831|OG000|Outcome|Ivermectin Plus Doxycycline|Ivermectin plus Doxycycline plus standard of care
11345450|NCT04523831|OG001|Outcome|Placebo|Placebo plus standard of care
11345451|NCT04523831|OG000|Outcome|Ivermectin Plus Doxycycline|Ivermection plus Doxycycline Plus standard of Care
11345452|NCT04523831|EG000|Reported Event|Ivermectin and Doxycycline|Ivermectin Plus Doxycycline plus standard of care
11345453|NCT04523831|EG001|Reported Event|Placebo|Placebo plus standard of care
11345454|NCT04521777|BG000|Baseline|All Participants|In this single-arm trial, patients who were started on high dose corticosteroids (methylprednisolone or equivalent, 2mg/kg/day) for suspected Acute Graft Versus Host Disease were enrolled on the trial. In order monitor for muscle weakness, serial physical function measures were obtained (baseline, Day 14 after enrollment, Day 28, and Day 56). All enrolled patients were also instructed on a home-based exercise program.
11345455|NCT04521777|FG000|Participant Flow|All Participants|In this single-arm trial, patients who were started on high dose corticosteroids (methylprednisolone or equivalent, 2mg/kg/day) for suspected Acute Graft Versus Host Disease were enrolled on the trial. In order monitor for muscle weakness, serial physical function measures were obtained (baseline, Day 14 after enrollment, Day 28, and Day 56). All enrolled patients were also instructed on a home-based exercise program.
11345456|NCT04521777|OG000|Outcome|All Participants|In this single-arm trial, patients who were started on high dose corticosteroids (methylprednisolone or equivalent, 2mg/kg/day) for suspected Acute Graft Versus Host Disease were enrolled on the trial. In order monitor for muscle weakness, serial physical function measures were obtained (baseline, Day 14 after enrollment, Day 28, and Day 56). All enrolled patients were also instructed on a home-based exercise program.
11345457|NCT04521777|EG000|Reported Event|All Participants|In this single-arm trial, patients who were started on high dose corticosteroids (methylprednisolone or equivalent, 2mg/kg/day) for suspected Acute Graft Versus Host Disease were enrolled on the trial. In order monitor for muscle weakness, serial physical function measures were obtained (baseline, Day 14 after enrollment, Day 28, and Day 56). All enrolled patients were also instructed on a home-based exercise program.
11345458|NCT04512703|BG000|Baseline|Healthy Group|"Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.~µCor: Sensor Monitor for arrhythmia and other bio-metric markers"
11345459|NCT04512703|BG001|Baseline|Arrhythmia Monitoring Group|"Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.~µCor: Sensor Monitor for arrhythmia and other bio-metric markers"
11345460|NCT04512703|BG002|Baseline|Total|Total of all reporting groups
11345461|NCT04512703|FG000|Participant Flow|Healthy Group|"Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.~µCor: Sensor Monitor for arrhythmia and other bio-metric markers"
11345462|NCT04512703|FG001|Participant Flow|Arrhythmia Monitoring Group|"Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.~µCor: Sensor Monitor for arrhythmia and other bio-metric markers"
11345463|NCT04512703|OG000|Outcome|Front Position Devices|Devices placed in the front position
11345464|NCT04512703|OG001|Outcome|Side Position Devices|Devices placed in the side position
11345465|NCT04512703|OG000|Outcome|Front Position Devices|Devices placed in the front position indicated for 90 day monitoring
11345466|NCT04512703|OG001|Outcome|Side Position Devices|Devices placed in the side position indicated for long term monitoring
11345467|NCT04512703|OG000|Outcome|All Subjects|ECG arrythmia recordings were assessed for associations with documented symptoms in cases of arrhythmia reported symptoms
11345468|NCT04512703|EG000|Reported Event|Healthy Group|"Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.~µCor: Sensor Monitor for arrhythmia and other bio-metric markers"
11345469|NCT04512703|EG001|Reported Event|Arrhythmia Monitoring Group|"Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.~µCor: Sensor Monitor for arrhythmia and other bio-metric markers"
11345470|NCT04511520|BG000|Baseline|Physical Training|"Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)~Physical training program"
11345471|NCT04511520|BG001|Baseline|Trimetazidine|"Treatment of trimetazidine in addition to standart therapy~Trimetazidine"
11345472|NCT04511520|BG002|Baseline|Control|Standard follow-up at the participating heart center
11345473|NCT04511520|BG003|Baseline|Total|Total of all reporting groups
11345474|NCT04511520|FG000|Participant Flow|Physical Training|"Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)~Physical training program"
11345475|NCT04511520|FG001|Participant Flow|Trimetazidine|"Treatment of trimetazidine in addition to standard therapy~Trimetazidine"
11345476|NCT04511520|FG002|Participant Flow|Control|Standard follow-up at the participating heart center
11345477|NCT04511520|OG000|Outcome|Physical Training|"Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)~Physical training program"
11345478|NCT04511520|OG001|Outcome|Trimetazidine|"Treatment of trimetazidine in addition to standard therapy~Trimetazidine"
11345479|NCT04511520|OG002|Outcome|Control|Standard follow-up at the participating heart center
11345480|NCT04511520|OG000|Outcome|Physical Training|"Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)~Physical training programme"
11345481|NCT04511520|EG000|Reported Event|Physical Training|"Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)~Physical training program"
11345482|NCT04511520|EG001|Reported Event|Trimetazidine|"Treatment of trimetazidine in addition to standart therapy~Trimetazidine"
10855275|NCT00328198|FG000|Participant Flow|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
11345483|NCT04511520|EG002|Reported Event|Control|Standard follow-up at the participating heart center
11345484|NCT04507776|BG000|Baseline|Etanercept|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
11345485|NCT04507776|FG000|Participant Flow|Etanercept|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
11345486|NCT04507776|OG000|Outcome|Etanercept|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
11345487|NCT04507776|OG000|Outcome|Etanercept: Participants Adherent to Treatment|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice and were adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.
11345488|NCT04507776|OG001|Outcome|Etanercept: Participants Not Adherent to Treatment|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice and were not adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.
11345489|NCT04507776|OG000|Outcome|Etanercept: Participants Adherent to Treatment|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
11345490|NCT04507776|OG001|Outcome|Etanercept: Participants Not Adherent to Treatment|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
11345491|NCT04507776|OG001|Outcome|Etanercept: Participants Not Adherent to Treatment|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice and were not adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study
11345492|NCT04507776|EG000|Reported Event|Etanercept|Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
11345493|NCT04502979|BG000|Baseline|Responsive Feeding|Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.
11345494|NCT04502979|BG001|Baseline|Routine Care|No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
11345495|NCT04502979|BG002|Baseline|Total|Total of all reporting groups
11345496|NCT04502979|FG000|Participant Flow|Responsive Feeding|Intervention families will receive approximately 4 hours of American Sign Language (ASL) and development-specific content related to language and feeding during home visits and phone calls. The initial in-home session with families focused on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs are left with families at the end of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.
11345497|NCT04502979|FG001|Participant Flow|Routine Care|No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
11345498|NCT04502979|OG000|Outcome|Responsive Feeding|Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.
11345499|NCT04502979|OG001|Outcome|Routine Care|No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
11345500|NCT04502979|EG000|Reported Event|Responsive Feeding|Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.
11345501|NCT04502979|EG001|Reported Event|Routine Care|No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
11345502|NCT04502056|BG000|Baseline|Intervention|Participants who are assigned to any intervention groups
11345503|NCT04502056|BG001|Baseline|Control|Participants who are assigned to a control group
11345504|NCT04502056|BG002|Baseline|Total|Total of all reporting groups
11345505|NCT04502056|FG000|Participant Flow|Intervention: AMA RI - B- B - R|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will include information on the disproportionate impact on communities of color .~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.~Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts"
11345506|NCT04502056|FG001|Participant Flow|Intervention: AMA RI - B - B - N|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will not include information on the disproportionate impact on communities of color.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.~No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted"
11345507|NCT04502056|FG002|Participant Flow|Intervention: AMA RI - W - W - R|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will include information on the disproportionate impact on communities of color.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts~White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement~White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video"
11345508|NCT04502056|FG003|Participant Flow|Intervention: AMA RI - W - W - N|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will not include information on the disproportionate impact on communities of color.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement~White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video~No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted"
11345509|NCT04502056|FG004|Participant Flow|Intervention: AMA DP - B- B - R|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will include information on the disproportionate impact on communities of color .~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.~Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing"
11345510|NCT04502056|FG005|Participant Flow|Intervention: AMA DP - B- B - N|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will not include information on the disproportionate impact on communities of color.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing~No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted"
11345511|NCT04502056|FG006|Participant Flow|Intervention: AMA DP - W- W - R|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will include information on the disproportionate impact on communities of color.~Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing~White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement~White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video"
11345512|NCT04502056|FG007|Participant Flow|Intervention: AMA DP - W- W - N|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will not include information on the disproportionate impact on communities of color.~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing~White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement~White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video~No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted"
11345513|NCT04502056|FG008|Participant Flow|Control: AMA RI - B - B|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - No message on Covid-19 will be shown.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA"
11345514|NCT04502056|FG009|Participant Flow|Control: AMA RI - W - W|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will also be white - No message on Covid-19 will be shown.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~White Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a white sender in acknowledgment of AMA"
11345515|NCT04502056|FG010|Participant Flow|Control: AMA DP - B - B|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - No message on Covid-19 will be shown.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing"
11345516|NCT04502056|FG011|Participant Flow|Control: AMA DP - W - W|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will also be white - No message on Covid-19 will be shown.~White Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a white sender in acknowledgment of AMA~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing"
11345517|NCT04502056|OG000|Outcome|Intervention|Participants who are assigned to any intervention groups
11345518|NCT04502056|OG001|Outcome|Control|Participants who are assigned to a control group
11345519|NCT04502056|OG000|Outcome|Within Intervention Group: Black Physician (Arm A) vs. White Physician (Arm B)|The relative IRR for intervention participants who saw a message delivered by a Black doctor and saw covid-19-related messages vs. those who did not see either or neither of the messages.
11345520|NCT04502056|OG001|Outcome|Within Intervention Group: AMA Anti-racism (Arm A) vs. Either/Neither (Arm B)|The relative IRR for intervention participants who saw the AMA anti-racism treatment and saw covid-19-related messages vs. those who did not see either or neither of the messages.
11345521|NCT04502056|OG002|Outcome|Within Intervention Group: Doctor Racial Disparity (Arm A) vs. Either/Neither (Arm B)|The relative IRR for intervention participants who saw the message on the relative incidence of COVID-19 among Black and white individuals and saw covid-19-related messages vs. those who did not see either or neither of the messages.
11345522|NCT04502056|OG003|Outcome|Within Control Group: Black Physician (Arm A) vs. White Physician (Arm B)|The relative IRR for intervention participants who saw a Black doctor vs. white doctor
11345523|NCT04502056|OG004|Outcome|Within Control Group: AMA Anti-racism vs. Either/Neither|The relative IRR for intervention participants who saw the AMA anti-racism treatment vs. those who saw the placebo message.
11345524|NCT04502056|OG005|Outcome|Intervention Group vs. Control Group|The relative IRR for intervention participants who saw covid-related messages vs. those who did not see any covid-19 related messages.
11345525|NCT04502056|EG000|Reported Event|Intervention: AMA RI - B- B - R|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will include information on the disproportionate impact on communities of color .~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.~Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts"
11345526|NCT04502056|EG001|Reported Event|Intervention: AMA RI - B - B - N|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will not include information on the disproportionate impact on communities of color.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.~No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted"
11345527|NCT04502056|EG002|Reported Event|Intervention: AMA RI - W - W - R|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will include information on the disproportionate impact on communities of color.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts~White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement~White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video"
11345528|NCT04502056|EG003|Reported Event|Intervention: AMA RI - W - W - N|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will not include information on the disproportionate impact on communities of color.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement~White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video~No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted"
11345529|NCT04502056|EG004|Reported Event|Intervention: AMA DP - B- B - R|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will include information on the disproportionate impact on communities of color .~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.~Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing"
11345530|NCT04502056|EG005|Reported Event|Intervention: AMA DP - B- B - N|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will not include information on the disproportionate impact on communities of color.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing~No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted"
11345531|NCT04502056|EG006|Reported Event|Intervention: AMA DP - W- W - R|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will include information on the disproportionate impact on communities of color.~Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing~White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement~White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video"
11345532|NCT04502056|EG007|Reported Event|Intervention: AMA DP - W- W - N|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will not include information on the disproportionate impact on communities of color.~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing~White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement~White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video~No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted"
11345533|NCT04502056|EG008|Reported Event|Control: AMA RI - B - B|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - No message on Covid-19 will be shown.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA"
11345534|NCT04502056|EG009|Reported Event|Control: AMA RI - W - W|"Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will also be white - No message on Covid-19 will be shown.~Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.~White Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a white sender in acknowledgment of AMA"
11345535|NCT04502056|EG010|Reported Event|Control: AMA DP - B - B|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - No message on Covid-19 will be shown.~African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing"
11345536|NCT04502056|EG011|Reported Event|Control: AMA DP - W - W|"Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will also be white - No message on Covid-19 will be shown.~White Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a white sender in acknowledgment of AMA~AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing"
11345537|NCT04498403|BG000|Baseline|Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years|Participants aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
11345538|NCT04498403|BG001|Baseline|Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years|Participants aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
11345539|NCT04498403|BG002|Baseline|Total|Total of all reporting groups
11345540|NCT04498403|FG000|Participant Flow|Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years|Participants aged < 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
11345541|NCT04498403|FG001|Participant Flow|Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years|Participants aged >= 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
11345542|NCT04498403|OG000|Outcome|Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years|Participants aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
11345543|NCT04498403|OG001|Outcome|Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years|Participants aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
11345544|NCT04498403|EG000|Reported Event|Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years|Participants aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
10845403|NCT00266877|BG000|Baseline|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
11345545|NCT04498403|EG001|Reported Event|Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years|Participants aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
11345546|NCT04495374|BG000|Baseline|Group P(0) - Placebo|"Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B~Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure"
11345547|NCT04495374|BG001|Baseline|Group P(1) - Pregabalin 300mg|"Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B~Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure"
11345548|NCT04495374|BG002|Baseline|Total|Total of all reporting groups
11345549|NCT04495374|FG000|Participant Flow|Group P(0) - Placebo|"Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B~Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure"
11345550|NCT04495374|FG001|Participant Flow|Group P(1) - Pregabalin 300mg|"Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B~Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure"
11345551|NCT04495374|OG000|Outcome|Group P(0) - Placebo|"Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B~Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure"
11345552|NCT04495374|OG001|Outcome|Group P(1) - Pregabalin 300mg|"Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B~Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure"
11345553|NCT04495374|EG000|Reported Event|Group P(0) - Placebo|"Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B~Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure"
11345554|NCT04495374|EG001|Reported Event|Group P(1) - Pregabalin 300mg|"Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B~Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure"
11345555|NCT04495712|BG000|Baseline|Spironolactone|"Patients randomized to active therapy with spironolactone~spironolactone: aldosterone blocker"
11345556|NCT04495712|BG001|Baseline|Placebo|"patients randomized to placebo~placebo: identical in appearance to spironolactone study drug"
11345557|NCT04495712|BG002|Baseline|Total|Total of all reporting groups
11345558|NCT04495712|FG000|Participant Flow|Spironolactone|"Patients randomized to active therapy with spironolactone~spironolactone: aldosterone blocker"
11345559|NCT04495712|FG001|Participant Flow|Placebo|"patients randomized to placebo~placebo: identical in appearance to spironolactone study drug"
11345560|NCT04495712|OG000|Outcome|Spironolactone|"Patients randomized to active therapy with spironolactone~spironolactone: aldosterone blocker"
11345561|NCT04495712|OG001|Outcome|Placebo|"patients randomized to placebo~placebo: identical in appearance to spironolactone study drug"
11345562|NCT04495712|EG000|Reported Event|Spironolactone|"Patients randomized to active therapy with spironolactone~spironolactone: aldosterone blocker"
11345563|NCT04495712|EG001|Reported Event|Placebo|"patients randomized to placebo~placebo: identical in appearance to spironolactone study drug"
11345564|NCT04492397|BG000|Baseline|Overall Study|"Subjects will be randomized to wear control lenses and test lenses for one week.~Contact lenses: Test Contact Lens Contact lenses: Control Contact Lens"
11345565|NCT04492397|FG000|Participant Flow|Test Contact Lens the Control Contact Lens|"Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.~Test Contact Lens: Subjects will be randomized to wear test lenses.~Control Contact Lens: Subjects will be randomized to wear control lenses."
11345566|NCT04492397|FG001|Participant Flow|Control Contact Lens Then Test Contact Lens|"Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.~Test Contact Lens: Subjects will be randomized to wear test lenses.~Control Contact Lens: Subjects will be randomized to wear control lenses."
11345567|NCT04492397|OG000|Outcome|Test Contact Lens|"Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.~Contact lenses: Test Contact Lens"
11345568|NCT04492397|OG001|Outcome|Control Contact Lens|"Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.~Contact lenses: Control Contact Lens"
11345569|NCT04492397|EG000|Reported Event|Test Contact Lens|Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.
11345570|NCT04492397|EG001|Reported Event|Control Contact Lens|Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
11345571|NCT04491994|BG000|Baseline|Supportive Arm|Patients selected in supportive arm will be given standard doses of oral Vit C, Vit D, Zinc and panadol
11345572|NCT04491994|BG001|Baseline|HCQ Arm|"Patients selected in experimental arm will be given standard doses of tab HCQ in addition to supportive treatment. side effects will be monitored~HCQ: Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days"
11345573|NCT04491994|BG002|Baseline|Total|Total of all reporting groups
11345574|NCT04491994|FG000|Participant Flow|Control Group|Standard of care (SOC) treatment comprised of oral Vit C, oral Zinc, oral Vit-D and tablet Paracetamol (for body aches/fever), intravenous fluids, hemodynamic monitoring, and laboratory testing for SARS-CoV-2 and baseline blood parameters.
11345575|NCT04491994|FG001|Participant Flow|Intervention Group|"Patients selected in experimental arm will be given standard doses of tab HCQ in addition to standard of care (SOC) treatment. side effects will be monitored~HCQ: Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days"
11345576|NCT04491994|OG000|Outcome|Standard of Care (SOC)|Standard of care (SOC) treatment comprised of daily oral Vit C (2gms), oral Zinc (50mg), oral Vit-D (alfacalcidol 1ug) and tablet Paracetamol (for body aches/fever), intravenous fluids, hemodynamic monitoring, and laboratory testing for SARS-CoV-2 and baseline blood parameters
11345577|NCT04491994|OG001|Outcome|Intervention Group|Patients selected in intervention arm were given HCQ in addition to standard of care treatment. After 12 hours of randomization HCQ was given. Standard dose of HCQ was 400 mg by mouth twice a day for day one followed by 200 mg 12 hourly for next 5 days.
11345578|NCT04491994|EG000|Reported Event|Control Group|Standard of care (SOC) treatment comprised of oral Vit C, oral Zinc, oral Vit-D and tablet Paracetamol (for body aches/fever), intravenous fluids, hemodynamic monitoring, and laboratory testing for SARS-CoV-2 and baseline blood parameters.
11345579|NCT04491994|EG001|Reported Event|Intervention Group|"Patients selected in experimental arm will be given standard doses of tab HCQ in addition to standard of care (SOC) treatment. side effects will be monitored~HCQ: Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days"
11345580|NCT04491240|BG000|Baseline|EXO-1|"Participants (n=10) in this group will receive standard therapy and exosomes of the first type.~EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the first type."
11345581|NCT04491240|BG001|Baseline|EXO-2|"Participants (n=10) in this group will receive standard therapy and exosomes of the second type.~EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the second type."
11345582|NCT04491240|BG002|Baseline|Placebo|"Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.~Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes)."
11345583|NCT04491240|BG003|Baseline|Total|Total of all reporting groups
11345584|NCT04491240|FG000|Participant Flow|EXO-1|"Participants (n=10) in this group will receive standard therapy and exosomes of the first type.~EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the first type."
11345585|NCT04491240|FG001|Participant Flow|EXO-2|"Participants (n=10) in this group will receive standard therapy and exosomes of the second type.~EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the second type."
11345586|NCT04491240|FG002|Participant Flow|Placebo|"Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.~Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes)."
11345587|NCT04491240|OG000|Outcome|EXO-1|"Participants (n=10) in this group will receive standard therapy and exosomes of the first type.~EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the first type."
11345588|NCT04491240|OG001|Outcome|EXO-2|"Participants (n=10) in this group will receive standard therapy and exosomes of the second type.~EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the second type."
11345589|NCT04491240|OG002|Outcome|Placebo|"Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.~Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes)."
11345590|NCT04491240|EG000|Reported Event|EXO-1|"Participants (n=10) in this group will receive standard therapy and exosomes of the first type.~EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the first type."
11345591|NCT04491240|EG001|Reported Event|EXO-2|"Participants (n=10) in this group will receive standard therapy and exosomes of the second type.~EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the second type."
11345592|NCT04491240|EG002|Reported Event|Placebo|"Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.~Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes)."
11345593|NCT04490863|BG000|Baseline|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse oximeter & DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin"
11345594|NCT04490863|FG000|Participant Flow|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse oximeter & DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin"
11345595|NCT04490863|OG000|Outcome|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse oximeter & DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin"
11345596|NCT04490863|EG000|Reported Event|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse oximeter & DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin"
11345597|NCT04490499|BG000|Baseline|HBVAXPRO™|Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).
10845404|NCT00266877|BG001|Baseline|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
11345598|NCT04490499|FG000|Participant Flow|HBVAXPRO™|Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).
11345599|NCT04490499|OG000|Outcome|HBVAXPRO™|Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).
11345600|NCT04490499|EG000|Reported Event|HBVAXPRO™|Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).
11345601|NCT04490239|BG000|Baseline|Experimental Arm|"Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.~Acute phase:~On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.~On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.~Chronic phase:~The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.~Intranasal heparin sodium (porcine): Intranasal heparin sodium"
11345602|NCT04490239|FG000|Participant Flow|Experimental Arm|"Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.~Acute phase:~On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.~On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.~Chronic phase:~The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.~Intranasal heparin sodium (porcine): Intranasal heparin sodium"
11345603|NCT04490239|OG000|Outcome|Experimental Arm|"Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.~Acute phase:~On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.~On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.~Chronic phase:~The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.~Intranasal heparin sodium (porcine): Intranasal heparin sodium"
11345604|NCT04490239|EG000|Reported Event|Experimental Arm|"Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.~Acute phase:~On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.~On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.~Chronic phase:~The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records.~Intranasal heparin sodium (porcine): Intranasal heparin sodium"
11345605|NCT04486235|BG000|Baseline|Intervention|"Receive experiential pamphlet~Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight."
11345606|NCT04486235|BG001|Baseline|Control|No materials, usual care
11345607|NCT04486235|BG002|Baseline|Total|Total of all reporting groups
11345608|NCT04486235|FG000|Participant Flow|Intervention|"Receive experiential pamphlet~Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight."
11345609|NCT04486235|FG001|Participant Flow|Control|No materials, usual care
11345610|NCT04486235|OG000|Outcome|Intervention|"Receive experiential pamphlet~Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight."
11345611|NCT04486235|OG001|Outcome|Control|No materials, usual care
11345612|NCT04486235|OG000|Outcome|Feasibility, Tracked by Participant Flow|Feasibility was measured by tracking flow and calculating: 1) Percentage of patients who indicate verbal consent for screening, 2) percentage of eligible participants after screening, 2) percentage of participants who refuse to participate because of focus on weight, 3)percentage of participants who complete the experiential pamphlet. Study flow will be tracked by study staff and compared to pre-determined benchmarks
11345613|NCT04486235|EG000|Reported Event|Intervention|"Receive experiential pamphlet~Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight."
11345614|NCT04486235|EG001|Reported Event|Control|No materials, usual care
11345615|NCT04483011|BG000|Baseline|RiaGev, Then Comarator|RiaGev, 2000mg, BID, in Period 1, then cross-over to Comparator in Period 2, after 7-day washout.
11345616|NCT04483011|BG001|Baseline|Comparator, Then RiaGev|Comparator, BID, in Period 1, then cross-over to RiaGev 2000mg, BID, in Period 2 after 7-day washout.
11345617|NCT04483011|BG002|Baseline|Total|Total of all reporting groups
11345618|NCT04483011|FG000|Participant Flow|RiaGev, Then Comparator|RiaGev, 2000mg, BID, in Intervention Period 1, then 7 day washout, then cross-over to Comparator in Intervention Period 2
11345619|NCT04483011|FG001|Participant Flow|Comparator, Then RiaGev|Comparator, BID, in Intervention Period 1, then 7 day washout, then cross-over to RiaGev 2000mg BID in Intervention Period 2
11345620|NCT04483011|OG000|Outcome|RiaGev|"RiaGev, 2000mg, BID~RiaGev: Dietary supplementation"
11345621|NCT04483011|OG001|Outcome|Comparator|"Comparator matched to RiaGev, BID~Comparator: Dietary ingredients"
11345622|NCT04483011|OG001|Outcome|Comparator|"Comparator matched to RiaGev, BID~RiaGev: Dietary supplementation"
11345623|NCT04483011|OG001|Outcome|Comparator|"Comparator matched to RiaGev, BID~Comparator: Dietary ingredient"
11345624|NCT04483011|EG000|Reported Event|RiaGev|"RiaGev, 2000mg, BID~RiaGev: Dietary supplementation"
11345625|NCT04483011|EG001|Reported Event|Comparator|"Comparator matched to RiaGev, BID~Comparator: Dietary ingredient"
11345626|NCT04475588|BG000|Baseline|Arm A - Itolizumab + BSC|"IItolizumab IV infusion Itolizumab IV infusion: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.~BSC: similar to Arm B Drug: Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc"
11345627|NCT04475588|BG001|Baseline|Arm B - Best Supportive Care (BSC)|Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
11345628|NCT04475588|BG002|Baseline|Total|Total of all reporting groups
11345629|NCT04475588|FG000|Participant Flow|Arm A - Itolizumab + BSC|"Itolizumab IV infusion Itolizumab IV infusion: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.~BSC: similar to Arm B Drug: Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc"
11345630|NCT04475588|FG001|Participant Flow|Arm B - Best Supportive Care (BSC)|Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
11345631|NCT04475588|OG000|Outcome|Arm A - Itolizumab + BSC|"Itolizumab IV infusion Itolizumab IV infusion: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.~BSC: similar to Arm B Drug: Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc"
11345632|NCT04475588|OG001|Outcome|Arm B - Best Supportive Care (BSC)|Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
11345633|NCT04475588|OG000|Outcome|Arm A - Itolizumab + BSC|"Itolizumab IV infusion Itolizumab IV infusion: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.~BSC: similar to Arm B Drug: Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH,Steroids,Vitamins and Zinc"
11345634|NCT04475588|EG000|Reported Event|Arm A - Itolizumab + BSC|"Itolizumab IV infusion Itolizumab IV infusion: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.~BSC: similar to Arm B Drug: Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc"
11345635|NCT04475588|EG001|Reported Event|Arm B - Best Supportive Care (BSC)|Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
11345636|NCT04474496|BG000|Baseline|Marshallese Adults in the U.S.|"Marshallese persons 18 years of age or older currently residing in the United States~Assessing the impact of COVID-19: Surveying Marshallese adults in the U.S. to determine the impact of COVID-19"
11345637|NCT04474496|FG000|Participant Flow|Marshallese Adults in the U.S.|"Marshallese persons 18 years of age or older currently residing in the United States~Assessing the impact of COVID-19: Surveying Marshallese adults in the U.S. to determine the impact of COVID-19"
11345638|NCT04474496|OG000|Outcome|Marshallese Adults in the U.S.|"Marshallese persons 18 years of age or older currently residing in the United States~Assessing the impact of COVID-19: Surveying Marshallese adults in the U.S. to determine the impact of COVID-19"
11345639|NCT04474496|EG000|Reported Event|Marshallese Adults in the U.S.|"Marshallese persons 18 years of age or older currently residing in the United States~Assessing the impact of COVID-19: Surveying Marshallese adults in the U.S. to determine the impact of COVID-19"
11345640|NCT04448210|BG000|Baseline|Educational Website Intervention|"The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.~DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials."
11345641|NCT04448210|BG001|Baseline|Wait-list Control|The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
11345642|NCT04448210|BG002|Baseline|Total|Total of all reporting groups
11345643|NCT04448210|FG000|Participant Flow|Educational Website Intervention|"The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.~DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials."
11345644|NCT04448210|FG001|Participant Flow|Wait-list Control|The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
11345645|NCT04448210|OG000|Outcome|Educational Website Intervention|"The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.~DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials."
11345646|NCT04448210|OG001|Outcome|Wait-list Control|The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
11345647|NCT04448210|EG000|Reported Event|Educational Website Intervention|"The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.~DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials."
11345648|NCT04448210|EG001|Reported Event|Wait-list Control|This is a wait-list control group and they did not receive an intervention.
11345649|NCT04474405|BG000|Baseline|Brain PET Scan (AD Subjects)|AD subjects receiving a flortaucipir and florbetapir PET scan
11345650|NCT04474405|BG001|Baseline|Brain PET (MCI Subjects)|Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
11345651|NCT04474405|BG002|Baseline|Brain PET (YCN Subjects)|Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
11345652|NCT04474405|BG003|Baseline|Brain PET (OCN Subjects)|Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
11345653|NCT04474405|BG004|Baseline|Whole Body PET Scan|Subjects receiving a whole body PET scan after flortaucipir administration
11345654|NCT04474405|BG005|Baseline|MRI and Amyloid Extension Cohort|Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. [n=3 AD, n=2 MCI, n=1 OCN]
11345655|NCT04474405|BG006|Baseline|Total|Total of all reporting groups
11345656|NCT04474405|FG000|Participant Flow|Brain PET Scan (AD Subjects)|Alzheimer's disease (AD) subjects receiving a flortaucipir and florbetapir PET scan
11345657|NCT04474405|FG001|Participant Flow|Brain PET (MCI Subjects)|Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
11345658|NCT04474405|FG002|Participant Flow|Brain PET (YCN Subjects)|Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
11345659|NCT04474405|FG003|Participant Flow|Brain PET (OCN Subjects)|Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
11345660|NCT04474405|FG004|Participant Flow|Whole Body PET Scan|Subjects receiving a whole body PET scan after flortaucipir administration
11345661|NCT04474405|FG005|Participant Flow|MRI and Amyloid Extension Cohort|Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. [n=3 AD, n=2 MCI, n=1 OCN]
11345662|NCT04474405|OG000|Outcome|Brain PET Scan (AD Subjects)|AD subjects receiving a flortaucipir and florbetapir PET scan
11345663|NCT04474405|OG001|Outcome|Brain PET (MCI Subjects)|Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
11345664|NCT04474405|OG002|Outcome|Brain PET (YCN Subjects)|Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
11345665|NCT04474405|OG003|Outcome|Brain PET (OCN Subjects)|Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
11345666|NCT04474405|OG000|Outcome|Whole Body Flortaucipir PET Scan|Subjects receiving a whole body PET scan after flortaucipir administration
11345667|NCT04474405|OG000|Outcome|All Subjects/Brain PET|Includes all AD, MCI, YCN, and OCN subjects enrolled in the study with flortaucipir Brain PET scans
11345668|NCT04474405|EG000|Reported Event|Brain PET Scan (AD Subjects)|AD subjects receiving a flortaucipir and florbetapir PET scan
11345669|NCT04474405|EG001|Reported Event|Brain PET (MCI Subjects)|Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
11345670|NCT04474405|EG002|Reported Event|Brain PET (YCN Subjects)|Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
11345671|NCT04474405|EG003|Reported Event|Brain PET (OCN Subjects)|Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
11345672|NCT04474405|EG004|Reported Event|Whole Body PET Scan|Subjects receiving a whole body PET scan after flortaucipir administration
11345673|NCT04474405|EG005|Reported Event|MRI and Amyloid Extension Cohort|Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000
11345674|NCT04470375|BG000|Baseline|Middle School VR Students|Middle school students viewing the VR on PNE
11345675|NCT04470375|FG000|Participant Flow|Middle School VR Students|Middle school students viewing the VR on PNE
11345676|NCT04470375|OG000|Outcome|Middle School VR Students|Middle school students viewing the VR on PNE
11345677|NCT04470375|EG000|Reported Event|Middle School VR Students|Middle school students viewing the VR on PNE
11345678|NCT04468347|BG000|Baseline|Alzheimer's Disease (AD)|Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
11345679|NCT04468347|BG001|Baseline|Mild Cognitive Impairment (MCI)|Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
11345680|NCT04468347|BG002|Baseline|Subjective Memory Complainers (SMC)|Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
11345681|NCT04468347|BG003|Baseline|Cognitively Normal (CN)|Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
10976576|NCT00941070|FG000|Participant Flow|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
11345682|NCT04468347|BG004|Baseline|Total|Total of all reporting groups
11345683|NCT04468347|FG000|Participant Flow|Alzheimer's Disease (AD)|Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
11345684|NCT04468347|FG001|Participant Flow|Mild Cognitive Impairment (MCI)|Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
11345685|NCT04468347|FG002|Participant Flow|Subjective Memory Complainers (SMC)|Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
11345686|NCT04468347|FG003|Participant Flow|Cognitively Normal (CN)|Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
11345687|NCT04468347|OG000|Outcome|Alzheimer's Disease (AD)|Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
11345688|NCT04468347|OG001|Outcome|Mild Cognitive Impairment (MCI)|Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
11345689|NCT04468347|OG002|Outcome|Objectively Impaired|Combined AD and MCI group
11345690|NCT04468347|OG003|Outcome|Subjective Memory Complainers (SMC)|Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
11345691|NCT04468347|OG004|Outcome|Cognitively Normal (CN)|Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
11345692|NCT04468347|OG005|Outcome|Non-objectively Compared|Combined SMC and CN groups
11345693|NCT04468347|OG002|Outcome|Subjective Memory Complainers (SMC)|Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
11345694|NCT04468347|OG003|Outcome|Cognitively Normal (CN)|Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
11345695|NCT04468347|EG000|Reported Event|Alzheimer's Disease (AD)|Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
11345696|NCT04468347|EG001|Reported Event|Mild Cognitive Impairment (MCI)|Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
11345697|NCT04468347|EG002|Reported Event|Subjective Memory Complainers (SMC)|Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
11345698|NCT04468347|EG003|Reported Event|Cognitively Normal (CN)|Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
11345699|NCT04467424|BG000|Baseline|Pediatric Anesthesia With Ketofol|"ketamine, propofol~ketamine, propofol: anesthesia with ketofol in pediatric surgery"
11345700|NCT04467424|BG001|Baseline|Pediatric Anesthesia With Ketofol Plus Lidocaine|"ketamine, propofol, lidocaine~ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery"
11345701|NCT04467424|BG002|Baseline|Total|Total of all reporting groups
11345702|NCT04467424|FG000|Participant Flow|Pediatric Anesthesia With Ketofol|"ketamine, propofol~ketamine, propofol: anesthesia with ketofol in pediatric surgery"
11345703|NCT04467424|FG001|Participant Flow|Pediatric Anesthesia With Ketofol Plus Lidocaine|"ketamine, propofol, lidocaine~ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery"
11345704|NCT04467424|OG000|Outcome|Pediatric Anesthesia With Ketofol|"ketamine, propofol~ketamine, propofol: anesthesia with ketofol in pediatric surgery"
11345705|NCT04467424|OG001|Outcome|Pediatric Anesthesia With Ketofol Plus Lidocaine|"ketamine, propofol, lidocaine~ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery"
11345706|NCT04467424|EG000|Reported Event|Pediatric Anesthesia With Ketofol|"ketamine, propofol~ketamine, propofol: anesthesia with ketofol in pediatric surgery"
11345707|NCT04467424|EG001|Reported Event|Pediatric Anesthesia With Ketofol Plus Lidocaine|"ketamine, propofol, lidocaine~ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery"
11345708|NCT04465422|BG000|Baseline|Intervention Group|"In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.~Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345709|NCT04465422|BG001|Baseline|Control Group|"In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model.~At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345710|NCT04465422|BG002|Baseline|Total|Total of all reporting groups
11345711|NCT04465422|FG000|Participant Flow|Intervention Group|"We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.~Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345712|NCT04465422|FG001|Participant Flow|Control Group|"We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model. Execution for two weeks.~At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345713|NCT04465422|OG000|Outcome|Intervention Group|"We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.~Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345714|NCT04465422|OG001|Outcome|Control Group|"We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model. Execution for two weeks.~At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345715|NCT04465422|OG000|Outcome|Intervention Group|"In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.~Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345716|NCT04465422|OG001|Outcome|Control Group|"In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model.~At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345717|NCT04465422|EG000|Reported Event|Intervention Group|"In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.~Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345718|NCT04465422|EG001|Reported Event|Control Group|"In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model.~At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance."
11345719|NCT04463004|BG000|Baseline|Intervention|"Treatment infusion~Mavrilimumab: Treatment infusion"
11345720|NCT04463004|BG001|Baseline|Control|"Placebo infusion~Placebos: Placebo infusion"
11345721|NCT04463004|BG002|Baseline|Total|Total of all reporting groups
11345722|NCT04463004|FG000|Participant Flow|Intervention|"Treatment infusion~Mavrilimumab: Treatment infusion"
11345723|NCT04463004|FG001|Participant Flow|Control|"Placebo infusion~Placebos: Placebo infusion"
11345724|NCT04463004|OG000|Outcome|Intervention|"Treatment infusion~Mavrilimumab: Treatment infusion"
11345725|NCT04463004|OG001|Outcome|Control|"Placebo infusion~Placebos: Placebo infusion"
11345726|NCT04463004|EG000|Reported Event|Intervention|"Treatment infusion~Mavrilimumab: Treatment infusion"
11345727|NCT04463004|EG001|Reported Event|Control|"Placebo infusion~Placebos: Placebo infusion"
11345728|NCT04448561|BG000|Baseline|ASP8062 in Combination With Morphine|Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
10855276|NCT00328198|OG000|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
10855277|NCT00328198|EG000|Reported Event|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
10855278|NCT00328263|BG000|Baseline|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
11345729|NCT04448561|BG001|Baseline|Placebo in Combination With Morphine|Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
11345730|NCT04448561|BG002|Baseline|Total|Total of all reporting groups
11345731|NCT04448561|FG000|Participant Flow|ASP8062 in Combination With Morphine|Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
11345732|NCT04448561|FG001|Participant Flow|Placebo in Combination With Morphine|Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
11345733|NCT04448561|OG000|Outcome|ASP8062|Participants received ASP8062 tablet, orally once daily on days 1 through 9.
11345734|NCT04448561|OG001|Outcome|ASP8062 in Combination With Morphine|Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
11345735|NCT04448561|OG002|Outcome|Placebo|Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
11345736|NCT04448561|OG003|Outcome|Placebo in Combination With Morphine|Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
11345737|NCT04448561|OG000|Outcome|ASP8062 in Combination With Morphine|Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
11345738|NCT04448561|OG001|Outcome|Placebo in Combination With Morphine|Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
11345739|NCT04448561|OG000|Outcome|ASP8062 in Combination With Morphine|Participants received ASP8062 tablet, orally once day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
11345740|NCT04448561|OG001|Outcome|Placebo Combination With Morphine|Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
11345741|NCT04448561|EG000|Reported Event|ASP8062|Participants received ASP8062 tablet, orally once daily on days 1 through 9.
11345742|NCT04448561|EG001|Reported Event|ASP8062 in Combination With Morphine|Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
11345743|NCT04448561|EG002|Reported Event|Placebo|Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
11345744|NCT04448561|EG003|Reported Event|Placebo in Combination With Morphine|Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
11345745|NCT04462731|BG000|Baseline|Obturation Technique: WVT|Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
11345746|NCT04462731|BG001|Baseline|Obturation Technique: SBT|Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
11345747|NCT04462731|BG002|Baseline|Total|Total of all reporting groups
11345748|NCT04462731|FG000|Participant Flow|Obturation Technique: WVT|Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
11345749|NCT04462731|FG001|Participant Flow|Obturation Technique: SBT|Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
11345750|NCT04462731|OG000|Outcome|Obturation Technique: WVT|Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
10855279|NCT00328263|BG001|Baseline|Placebo|98g/day of placebo (devoid of microorganisms)
11345751|NCT04462731|OG001|Outcome|Obturation Technique: SBT|Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
11345752|NCT04462731|EG000|Reported Event|Obturation Technique: WVT|Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
11345753|NCT04462731|EG001|Reported Event|Obturation Technique: SBT|Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
11345754|NCT04459585|BG000|Baseline|Dabigatran Etexilate/Dabigatran Etexilate + Quizartinib|Participants who received a single oral dose of 150mg dabigatran etexilate on Day 1 of Period 1 and then received a single oral dose of 60mg quizartinib 2 hours prior to the administration of a single oral dose of 150mg dabigatran etexilate on the morning of Day 5 of Period 2.
11345755|NCT04459585|FG000|Participant Flow|Dabigatran Etexilate/Dabigatran Etexilate + Quizartinib|Participants who received a single oral dose of 150mg dabigatran etexilate on Day 1 of Period 1 and then received a single oral dose of 60mg quizartinib 2 hours prior to the administration of a single oral dose of 150mg dabigatran etexilate on the morning of Day 5 of Period 2.
11345756|NCT04459585|OG000|Outcome|Period 1: Dabigatran Etexilate|Participants who received a single oral dose of 150mg dabigatran etexilate on Day 1 of Period 1.
11345757|NCT04459585|OG001|Outcome|Period 2: Dabigatran Etexilate + Quizartinib|Participants who received a single oral dose of 60mg quizartinib 2 hours prior to the administration of a single oral dose of 150mg dabigatran etexilate on Day 5 of Period 2.
11345758|NCT04459585|OG000|Outcome|Period 2: Dabigatran Etexilate + Quizartinib|Participants who received a single oral dose of 60mg quizartinib 2 hours prior to the administration of a single oral dose of 150mg dabigatran etexilate on Day 5 of Period 2.
11345759|NCT04459585|EG000|Reported Event|Period 1: Dabigatran Etexilate|Participants who received a single oral dose of 150mg dabigatran etexilate on Day 1 of Period 1.
11345760|NCT04459585|EG001|Reported Event|Period 2: Dabigatran Etexilate + Quizartinib|Participants who received a single oral dose of 60mg quizartinib 2 hours prior to the administration of a single oral dose of 150mg dabigatran etexilate on Day 5 of Period 2.
11345761|NCT04458818|BG000|Baseline|Prolene Mesh Implant|"The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.~Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that."
11345762|NCT04458818|FG000|Participant Flow|Prolene Mesh Implant|"The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.~Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that."
11345763|NCT04458818|OG000|Outcome|Prolene Mesh Implant|"The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.~Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that."
11348546|NCT04160975|OG000|Outcome|Concordant (Arm A) vs. Discordant Expert Sender (Arm B) - Black Participants|"This group combines the following arms to measure the effect of racial concordance between sender and receiver (i.e. intervention) among Black Participants:~Black Participant-Concordant Sender-Expert Sender-Standard Signal (i.e. Arm A)~Black Participant-Discordant Sender-Expert Sender-Standard Signal (i.e. Arm B)~The arms are combined to test Hypothesis 1 prespecified in the analysis plan. The hypothesis tests how racial concordance between an expert sender and receiver affects the outcome among participants assigned to Arm A compared to those who are assigned to Arm B."
10855280|NCT00328263|BG002|Baseline|Total|Total of all reporting groups
10855281|NCT00328263|FG000|Participant Flow|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
10855282|NCT00328263|FG001|Participant Flow|Placebo|98g/day of placebo (devoid of microorganisms)
11345764|NCT04458818|EG000|Reported Event|Prolene Mesh Implant|"The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.~Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that."
11345765|NCT04456634|BG000|Baseline|AL&RUX|"Oral administration of:~• 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)~20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux): Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total)."
11345766|NCT04456634|BG001|Baseline|AL& Placebo|"20 mg/120 mg artemether-lumefantrine (AL) + Placebo~20 mg/120 mg artemether-lumefantrine (AL) + Placebo: Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total)."
11345767|NCT04456634|BG002|Baseline|Total|Total of all reporting groups
11345768|NCT04456634|FG000|Participant Flow|AL&RUX|"Oral administration of:~• 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)~20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux): Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total)."
11345769|NCT04456634|FG001|Participant Flow|AL& Placebo|"20 mg/120 mg artemether-lumefantrine (AL) + Placebo~20 mg/120 mg artemether-lumefantrine (AL) + Placebo: Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total)."
11345770|NCT04456634|OG000|Outcome|AL&RUX|"Oral administration of:~• 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)~20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux): Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total)."
11345771|NCT04456634|OG001|Outcome|AL& Placebo|"20 mg/120 mg artemether-lumefantrine (AL) + Placebo~20 mg/120 mg artemether-lumefantrine (AL) + Placebo: Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total)."
11345772|NCT04456634|EG000|Reported Event|AL&RUX|"Oral administration of:~• 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)~20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux): Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total)."
11345773|NCT04456634|EG001|Reported Event|AL& Placebo|"20 mg/120 mg artemether-lumefantrine (AL) + Placebo~20 mg/120 mg artemether-lumefantrine (AL) + Placebo: Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total)."
11345774|NCT04454138|BG000|Baseline|Non-targeted Placement of XEN 45|"Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.~XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area"
11345775|NCT04454138|BG001|Baseline|Targeted Supratenon's Placement of XEN 45|"Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.~XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area"
11345776|NCT04454138|BG002|Baseline|Total|Total of all reporting groups
11345777|NCT04454138|FG000|Participant Flow|Non-targeted Placement of XEN 45|"Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.~XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area"
11345778|NCT04454138|FG001|Participant Flow|Targeted Supratenon's Placement of XEN 45|"Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.~XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area"
11345779|NCT04454138|OG000|Outcome|Non-targeted Placement of XEN 45|"Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.~XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area"
11345780|NCT04454138|OG001|Outcome|Targeted Supratenon's Placement of XEN 45|"Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.~XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area"
11345781|NCT04454138|EG000|Reported Event|Non-targeted Placement of XEN 45|"Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.~XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area"
11345782|NCT04454138|EG001|Reported Event|Targeted Supratenon's Placement of XEN 45|"Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.~XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area"
11345783|NCT04452435|BG000|Baseline|C21 Treatment|Oral C21 treatment 100 mg twice daily for 7 days
11345784|NCT04452435|BG001|Baseline|Placebo Treatment|Oral placebo treatment twice daily for 7 days
11345785|NCT04452435|BG002|Baseline|Total|Total of all reporting groups
11345786|NCT04452435|FG000|Participant Flow|C21 Treatment|Oral C21 treatment 100 mg twice daily for 7 days
11345787|NCT04452435|FG001|Participant Flow|Placebo Treatment|Oral placebo treatment twice daily for 7 days
11345788|NCT04452435|OG000|Outcome|C21 Treatment|Oral C21 treatment 100 mg twice daily for 7 days
11345789|NCT04452435|OG001|Outcome|Placebo Treatment|Oral placebo treatment twice daily for 7 days
11345790|NCT04452435|EG000|Reported Event|C21 Treatment|Oral C21 treatment 100 mg twice daily for 7 days
11345791|NCT04452435|EG001|Reported Event|Placebo Treatment|Oral placebo treatment twice daily for 7 days
11345792|NCT04452435|EG002|Reported Event|No Treatment (Before Randomization)|Subjects that were enrolled in the trial but not randomized
11345793|NCT04451707|BG000|Baseline|Non-cholera Vibrio Infection|"Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019~non-cholera Vibrio infection: Epidemiology of patients diagnosed with non-cholera Vibrio infection"
11345794|NCT04451707|FG000|Participant Flow|Non-cholerae or Non-O1/O139 Vibrio Infection|Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
11345795|NCT04451707|OG000|Outcome|Non-cholerae or Non-O1/O139 Vibrio Infection|Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
11345796|NCT04451707|EG000|Reported Event|Non-cholerae or Non-O1/O139 Vibrio Infection|Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019
11345797|NCT04449263|BG000|Baseline|Overall Study|Subjects wore their habitual lenses for two weeks and then randomized to wear Test lens A and Control Lens B for 2 weeks.
11345798|NCT04449263|FG000|Participant Flow|Lens A (Test) Then Lens B (Control)|"Subjects wore their habitual lenses for 2 weeks and were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.~Contact lens: Habitual Lenses Contact Lens: Test Lens A Contact Lens: Control Lens B"
11345799|NCT04449263|FG001|Participant Flow|Lens B (Control) Then Lens A (Test)|"All Subjects wore their habitual lenses for 2 weeks prior to randomization and were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study.~Contact Lens: Habitual lenses~Contact lens: Control Lens B~Contact Lens : Test lens A"
11345800|NCT04449263|OG000|Outcome|Subjects Habitual Lenses|"Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.~Contact Lenses: Habitual Lenses"
11345801|NCT04449263|OG001|Outcome|Lens A (Test)|"Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.~Contact Lens: Test Lens A"
11345802|NCT04449263|OG002|Outcome|Lens B (Control)|"Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study.~Contact lens: Control Lens B"
11345803|NCT04449263|EG000|Reported Event|Subjects Habitual Lenses|"All Subjects wore their habitual lenses for 2 weeks prior to randomization of test lens and control lens.~Contact Lenses: Habitual Lenses"
11345804|NCT04449263|EG001|Reported Event|Lens A (Test)|"Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.~Contact Lens: Test Lens A"
10855283|NCT00328263|OG000|Outcome|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
10855284|NCT00328263|OG001|Outcome|Placebo|98g/day of placebo (devoid of microorganisms)
11345805|NCT04449263|EG002|Reported Event|Lens B (Control)|"Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study.~Contact lens: Control Lens B"
11348547|NCT04160975|OG001|Outcome|Concordant (Arm A) vs. Discordant Expert Sender (Arm B) - White Participants|"This group combines the following arms to measure the effect of racial concordance between sender and receiver (i.e. intervention) among White Participants:~White Participant-Concordant Sender-Expert Sender-Standard Signal (i.e. Arm A)~White Participant-Discordant Sender-Expert Sender-Standard Signal (i.e. Arm B)~The arms are combined to test Hypothesis 1 prespecified in the analysis plan. The hypothesis tests how racial concordance between an expert sender and receiver affects the outcome among participants assigned to Arm A compared to those who are assigned to Arm B."
11348548|NCT04160975|OG002|Outcome|Acknowledgement (Arm A) vs. Standard Signal (Arm B) - Black Participants|"This group combines the following arms to measure the effect of an acknowledgement signal (i.e. intervention) among Black Participants:~Black Participant-Discordant Sender-Expert Sender-Acknowledgement Signal (i.e. Arm A)~Black Participant-Discordant Sender-Expert Sender-Standard Signal (i.e. Arm B)~The arms are combined to test Hypothesis 4 prespecified in the analysis plan. The hypothesis tests how a signal that acknowledges past injustices affects the outcome among participants assigned to Arm A compared to those assigned to Arm B."
11348549|NCT04160975|OG003|Outcome|Layperson Sender (Arm A) vs. Expert Sender (Arm B) - Black Participants|"This group combines the following arms to measure the effect of a layperson sender (i.e. intervention) among Black Participants:~Black Participant-Concordant Sender-Lay Sender-Standard Signal (i.e. Arm A)~Black Participant-Concordant Sender-Expert Sender-Standard Signal (i.e. Arm B)~The arms are combined to test Hypothesis 3 prespecified in the analysis plan. The hypothesis tests how a layperson sender affects the outcome among participants assigned to Arm A compared to those assigned to Arm B."
11348550|NCT04160975|OG000|Outcome|Concordant (Arm A) vs. Discordant Expert Sender (Arm B) - Black Participants|"This group combines the following arms to measure the effect of racial concordance between sender and receiver (i.e. intervention) among Black Participants:~Black Participant-Concordant Sender-Expert Sender-Standard Signal (i.e. Arm A)~Black Participant-Discordant Sender-Expert Sender-Standard Signal (i.e. Arm B)"
11348551|NCT04160975|EG000|Reported Event|Black Participant-Concordant Sender-Expert Sender-Standard Signal|Black participants who are assigned to a concordant-exper sender delivering a standard signal.
11348552|NCT04160975|EG001|Reported Event|Black Participant-Concordant Sender-Lay Sender-Standard Signal|Black participants who are assigned to a concordant-lay sender delivering a standard signal.
11348553|NCT04160975|EG002|Reported Event|Black Participant-Discordant Sender-Expert Sender-Standard Signal|Black participants who are assigned to a discordant-exper sender delivering a standard signal.
11348554|NCT04160975|EG003|Reported Event|Black Participant-Discordant Sender-Expert Sender-Acknowledgement Signal|Black participants who are assigned to a discordant-exper sender delivering a acknowledgement signal.
11348555|NCT04160975|EG004|Reported Event|White Participant-Concordant Sender-Expert Sender-Standard Signal|White participants who are assigned to a concordant-exper sender delivering a standard signal.
11348556|NCT04160975|EG005|Reported Event|White Participant-Discordant Sender-Expert Sender-Standard Signal|White participants who are assigned to a discordant-exper sender delivering a standard signal.
11348557|NCT04153409|BG000|Baseline|LAT8881, Then Placebo|Subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity.
11345806|NCT04450381|BG000|Baseline|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse oximeter & DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin"
11345807|NCT04450381|FG000|Participant Flow|Test Subjects|"All subjects are enrolled and receive the Pulse oximeter & sensor for measurement of hemoglobin.~Rad-67 Pulse oximeter & DCI mini sensor: Noninvasive pulse oximeter that measures hemoglobin"
11345808|NCT04450381|OG000|Outcome|Test Subjects|"All subjects are enrolled and receive the Pulse oximeter & sensor for measurement of hemoglobin.~Rad-67 Pulse oximeter & DCI mini sensor: Noninvasive pulse oximeter that measures hemoglobin"
11345809|NCT04450381|EG000|Reported Event|Test Subjects|"All subjects are enrolled and receive the Pulse oximeter & sensor for measurement of hemoglobin.~Rad-67 Pulse oximeter & DCI mini sensor: Noninvasive pulse oximeter that measures hemoglobin"
11345810|NCT04449341|BG000|Baseline|Standard Care Venipuncture With Additional of Virtual Reality|"Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset~Oculus Go headset with Ocean Rift application: Information already included in arm description"
11345811|NCT04449341|BG001|Baseline|Standard Care Venipuncture Without Addition of Virtual Reality|Patients undergoing blood draw while wearing Oculus Go headset that is turned off
11345812|NCT04449341|BG002|Baseline|Total|Total of all reporting groups
11345813|NCT04449341|FG000|Participant Flow|Virtual Reality|"Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset~Oculus Go headset with Ocean Rift application: Information already included in arm description"
11345814|NCT04449341|FG001|Participant Flow|Control|Patients undergoing blood draw while wearing Oculus Go headset that is turned off
11345815|NCT04449341|OG000|Outcome|Standard Care Venipuncture With Additional of Virtual Reality|"Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset~Oculus Go headset with Ocean Rift application: Information already included in arm description"
11345816|NCT04449341|OG001|Outcome|Standard Care Venipuncture Without Addition of Virtual Reality|Patients undergoing blood draw while wearing Oculus Go headset that is turned off
11345817|NCT04449341|EG000|Reported Event|Standard Care Venipuncture With Additional of Virtual Reality|"Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset~Oculus Go headset with Ocean Rift application: Information already included in arm description"
11345818|NCT04449341|EG001|Reported Event|Standard Care Venipuncture Without Addition of Virtual Reality|Patients undergoing blood draw while wearing Oculus Go headset that is turned off
11345819|NCT04441255|BG000|Baseline|Mobocertinib 160 mg Fasted + Mobocertinib 160 mg Fed|Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).
11345820|NCT04441255|BG001|Baseline|Mobocertinib 160 mg Fed + Mobocertinib 160 mg Fasted|Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).
11345821|NCT04441255|BG002|Baseline|Total|Total of all reporting groups
11345822|NCT04441255|FG000|Participant Flow|Mobocertinib 160 mg Fasted + Mobocertinib 160 mg Fed|Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).
11345823|NCT04441255|FG001|Participant Flow|Mobocertinib 160 mg Fed + Mobocertinib 160 mg Fasted|Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).
11345824|NCT04441255|OG000|Outcome|Mobocertinib 160 mg Fasted|Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
11345825|NCT04441255|OG001|Outcome|Mobocertinib 160 mg Fed|Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
11345826|NCT04441255|EG000|Reported Event|Mobocertinib 160 mg Fasted|Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
11345827|NCT04441255|EG001|Reported Event|Mobocertinib 160 mg Fed|Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
11345828|NCT04439214|BG000|Baseline|Treatment (Nivolumab)|"Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nivolumab: Given IV"
11345829|NCT04439214|FG000|Participant Flow|Treatment (Nivolumab)|"Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nivolumab: Given IV"
11345830|NCT04439214|OG000|Outcome|Treatment (Nivolumab)|"Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nivolumab: Given IV"
11345831|NCT04439214|EG000|Reported Event|Treatment (Nivolumab)|Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11345832|NCT04439240|BG000|Baseline|Treatment (AZD4547)|"Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO"
11345833|NCT04439240|FG000|Participant Flow|Treatment (AZD4547)|"Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO"
11345834|NCT04439240|OG000|Outcome|Treatment (AZD4547)|"Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO"
11345835|NCT04439240|EG000|Reported Event|Treatment (AZD4547)|"Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO"
11345836|NCT04438785|BG000|Baseline|INTERVENTION (AirwayGym) GROUP|"Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.~The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days."
11345837|NCT04438785|BG001|Baseline|CONTROL GROUP|Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
11345838|NCT04438785|BG002|Baseline|Total|Total of all reporting groups
11345839|NCT04438785|FG000|Participant Flow|INTERVENTION (AirwayGym) GROUP|"Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.~The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days."
11345840|NCT04438785|FG001|Participant Flow|CONTROL GROUP|Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
11345841|NCT04438785|OG000|Outcome|INTERVENTION (AirwayGym) GROUP|"Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.~The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days."
11345842|NCT04438785|OG001|Outcome|CONTROL GROUP|Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
11345843|NCT04438785|EG000|Reported Event|INTERVENTION (AirwayGym) GROUP|"Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.~The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days."
11345844|NCT04438785|EG001|Reported Event|CONTROL GROUP|Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
11345845|NCT04431908|BG000|Baseline|Outpatients (Drive Thru)|"Patients receiving testing through a drive thru location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345846|NCT04431908|BG001|Baseline|High Risk Asymptomatics|"Asymptomatic patients (residents) in a high risk location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345847|NCT04431908|BG002|Baseline|Total|Total of all reporting groups
11345848|NCT04431908|FG000|Participant Flow|Outpatients (Drive Thru)|"Patients receiving testing through a drive thru location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345849|NCT04431908|FG001|Participant Flow|High Risk Asymptomatics|"Asymptomatic patients (health care workers) in a high risk location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345850|NCT04431908|OG000|Outcome|Outpatients (Drive Thru)|"Patients receiving testing through a drive thru location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345851|NCT04431908|OG001|Outcome|High Risk Asymptomatics|"Asymptomatic patients (residents) in a high risk location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345852|NCT04431908|OG000|Outcome|High Risk Asymptomatics|"Asymptomatic patients (residents) in a high risk location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345853|NCT04431908|EG000|Reported Event|Outpatients (Drive Thru)|"Patients receiving testing through a drive thru location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345854|NCT04431908|EG001|Reported Event|High Risk Asymptomatics|"Asymptomatic patients (health care workers) in a high risk location.~olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR)."
11345855|NCT04413929|BG000|Baseline|Ergoferon|Oral administration in the therapeutic dosage specified in the instructions for medical use.
11345856|NCT04413929|FG000|Participant Flow|Ergoferon|Oral administration in the therapeutic dosage specified in the instructions for medical use: 8 tablets on the first day of treatment (1 tablet every 30 minutes during the first 2 hours, then 3 more tablet intakes with regular intervals in between);from the second day until recovery take 1 tablet 3 times a day. The duration of the reception was regulated by the physician.
11345857|NCT04413929|OG000|Outcome|Ergoferon|"Oral administration in the therapeutic dosage specified in the instructions for medical use.~Ergoferon: Oral administration"
11345858|NCT04413929|OG000|Outcome|Ergoferon|Oral administration in the therapeutic dosage specified in the instructions for medical use.
11345859|NCT04413929|EG000|Reported Event|Ergoferon|"Oral administration in the therapeutic dosage specified in the instructions for medical use.~Ergoferon: Oral administration in the therapeutic dosage specified in the instructions for medical use."
11345860|NCT04430634|BG000|Baseline|ABDC|Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
11345861|NCT04430634|BG001|Baseline|BCAD|Same as previous but in a different randomization order
11345862|NCT04430634|BG002|Baseline|CDBA|Same as previous but in a different randomization order
11345863|NCT04430634|BG003|Baseline|DACB|Same as previous but in a different randomization order
11345864|NCT04430634|BG004|Baseline|EFHG|Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
11345865|NCT04430634|BG005|Baseline|FGEH|Same as previous but in a different randomization order
11345866|NCT04430634|BG006|Baseline|GHFE|Same as previous but in a different randomization order
11345867|NCT04430634|BG007|Baseline|HEGF|Same as previous but in a different randomization order
11345868|NCT04430634|BG008|Baseline|Total|Total of all reporting groups
11345869|NCT04430634|FG000|Participant Flow|ABDC|Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
11345870|NCT04430634|FG001|Participant Flow|BCAD|Same as previous but in a different randomization order
11345871|NCT04430634|FG002|Participant Flow|CDBA|Same as previous but in a different randomization order
11345872|NCT04430634|FG003|Participant Flow|DACB|Same as previous but in a different randomization order
11345873|NCT04430634|FG004|Participant Flow|EFHG|Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
11345874|NCT04430634|FG005|Participant Flow|FGEH|Same as previous but in a different randomization order
11345875|NCT04430634|FG006|Participant Flow|GHFE|Same as previous but in a different randomization order
11345876|NCT04430634|FG007|Participant Flow|HEGF|Same as previous but in a different randomization order
11345877|NCT04430634|OG000|Outcome|Product Variant A|MyBlu e-cigarette variant A (2.4% nicotine)
11345878|NCT04430634|OG001|Outcome|Product Variant B|MyBlu e-cigarette variant B (3.6% nicotine)
11345879|NCT04430634|OG002|Outcome|Product Variant C|MyBlu e-cigarette variant C (2.5% nicotine)
11345880|NCT04430634|OG003|Outcome|Product Variant D|MyBlu e-cigarette variant D (4.0% nicotine)
11345881|NCT04430634|OG004|Outcome|Product Variant E|MyBlu e-cigarette variant E (3.6% nicotine)
11345882|NCT04430634|OG005|Outcome|Product Variant F|MyBlu e-cigarette variant F (2.4% nicotine)
11345883|NCT04430634|OG006|Outcome|Product Variant G|MyBlu e-cigarette variant G (4.0% nicotine)
11345884|NCT04430634|OG007|Outcome|Product Variant H|MyBlu e-cigarette variant H (3.6% nicotine)
11345885|NCT04430634|OG000|Outcome|Exclusive MyBlu E-cigarette Use|Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
11345886|NCT04430634|EG000|Reported Event|Product Variant A|MyBlu e-cigarette variant A (2.4% nicotine)
11345887|NCT04430634|EG001|Reported Event|Product Variant B|MyBlu e-cigarette variant B (3.6% nicotine)
11345888|NCT04430634|EG002|Reported Event|Product Variant C|MyBlu e-cigarette variant C (2.5% nicotine)
11345889|NCT04430634|EG003|Reported Event|Product Variant D|MyBlu e-cigarette variant D (4.0% nicotine)
11345890|NCT04430634|EG004|Reported Event|Product Variant E|MyBlu e-cigarette variant E (3.6% nicotine)
11345891|NCT04430634|EG005|Reported Event|Product Variant F|MyBlu e-cigarette variant F (2.4% nicotine)
11345892|NCT04430634|EG006|Reported Event|Product Variant G|MyBlu e-cigarette variant G (4.0% nicotine)
11345893|NCT04430634|EG007|Reported Event|Product Variant H|MyBlu e-cigarette variant H (3.6% nicotine)
11345894|NCT04429932|BG000|Baseline|Product Use Sequence ABDC|"Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).~Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine~Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine~Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine~Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine"
11345895|NCT04429932|BG001|Baseline|Product Use Sequence BCAD|"Same as previous arm, but in a different randomization order.~Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine~Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine~Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine~Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine"
11345896|NCT04429932|BG002|Baseline|Product Use Sequence CDBA|"Same as previous arm, but in a different randomization order.~Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine~Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine~Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine"
11345897|NCT04429932|BG003|Baseline|Product Use Sequence DACB|"Same as previous arm, but in a different randomization order.~Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine~Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine~Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine~Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine"
11348558|NCT04153409|BG001|Baseline|Placebo, Then LAT8881|Subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity.
11348559|NCT04153409|BG002|Baseline|Total|Total of all reporting groups
11345898|NCT04429932|BG004|Baseline|Product Use Sequence EFHG|"Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).~Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine~Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine~Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine~Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine"
11345899|NCT04429932|BG005|Baseline|Product Use Sequence FGEH|"Same as previous arm, but in a different randomization order.~Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine~Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine~Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine~Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine"
11345900|NCT04429932|BG006|Baseline|Product Use Sequence GHFE|"Same as previous arm, but in a different randomization order.~Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine~Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine~Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine~Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine"
11345901|NCT04429932|BG007|Baseline|Product Use Sequence HEGF|"Same as previous arm, but in a different randomization order.~Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine~Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine~Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine~Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine"
11345902|NCT04429932|BG008|Baseline|Total|Total of all reporting groups
10855285|NCT00328263|EG000|Reported Event|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
10855286|NCT00328263|EG001|Reported Event|Placebo|98g/day of placebo (devoid of microorganisms)
10855287|NCT00328510|BG000|Baseline|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
11345903|NCT04429932|FG000|Participant Flow|Product Use Sequence ABDC|"Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).~Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine~Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine~Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine~Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine"
11348560|NCT04153409|FG000|Participant Flow|LAT8881, Then Placebo|Subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity.
10855288|NCT00328510|BG001|Baseline|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
10855289|NCT00328510|BG002|Baseline|Total|Total of all reporting groups
10855290|NCT00328510|FG000|Participant Flow|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
10855291|NCT00328510|FG001|Participant Flow|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
10855292|NCT00328510|OG000|Outcome|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
10855293|NCT00328510|OG001|Outcome|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
10855294|NCT00328510|EG000|Reported Event|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
10855295|NCT00328510|EG001|Reported Event|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
10855296|NCT00328562|BG000|Baseline|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
10855297|NCT00328562|FG000|Participant Flow|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy"
10855298|NCT00328562|OG000|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
10855299|NCT00328562|EG000|Reported Event|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
10855300|NCT00328614|BG000|Baseline|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855301|NCT00328614|BG001|Baseline|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855302|NCT00328614|BG002|Baseline|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855303|NCT00328614|BG003|Baseline|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855304|NCT00328614|BG004|Baseline|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855305|NCT00328614|BG005|Baseline|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855306|NCT00328614|BG006|Baseline|Total|Total of all reporting groups
11345904|NCT04429932|FG001|Participant Flow|Product Use Sequence BCAD|"Same as previous arm, but in a different randomization order.~Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine~Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine~Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine~Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine"
11345905|NCT04429932|FG002|Participant Flow|Product Use Sequence CDBA|"Same as previous arm, but in a different randomization order.~Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine~Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine~Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine"
11345906|NCT04429932|FG003|Participant Flow|Product Use Sequence DACB|"Same as previous arm, but in a different randomization order.~Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine~Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine~Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine~Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine"
11345907|NCT04429932|FG004|Participant Flow|Product Use Sequence EFHG|"Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).~Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine~Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine~Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine~Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine"
11345908|NCT04429932|FG005|Participant Flow|Product Use Sequence FGEH|"Same as previous arm, but in a different randomization order.~Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine~Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine~Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine~Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine"
11345909|NCT04429932|FG006|Participant Flow|Product Use Sequence GHFE|"Same as previous arm, but in a different randomization order.~Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine~Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine~Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine~Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine"
11345910|NCT04429932|FG007|Participant Flow|Product Use Sequence HEGF|"Same as previous arm, but in a different randomization order.~Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine~Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine~Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine~Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine"
11345911|NCT04429932|OG000|Outcome|Product Variant A|MyBlu e-cigarette variant A (2.4% nicotine)
11345912|NCT04429932|OG001|Outcome|Product Variant B|MyBlu e- igarette variant B (2.4% nicotine)
10855307|NCT00328614|FG000|Participant Flow|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855308|NCT00328614|FG001|Participant Flow|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855309|NCT00328614|FG002|Participant Flow|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855310|NCT00328614|FG003|Participant Flow|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855311|NCT00328614|FG004|Participant Flow|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855312|NCT00328614|FG005|Participant Flow|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855313|NCT00328614|OG000|Outcome|Samarium-153|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855314|NCT00328614|EG000|Reported Event|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
11345913|NCT04429932|OG002|Outcome|Product Variant C|MyBlu e-cigarette variant C (2.4% nicotine)
11345914|NCT04429932|OG003|Outcome|Product Variant D|MyBlu e-cigarette variant D (2.4% nicotine)
11345915|NCT04429932|OG004|Outcome|Product Variant E|MyBlu e- cigarette variant E (1.2% nicotine)
10855315|NCT00328614|EG001|Reported Event|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855316|NCT00328614|EG002|Reported Event|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855317|NCT00328614|EG003|Reported Event|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855318|NCT00328614|EG004|Reported Event|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855319|NCT00328614|EG005|Reported Event|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
10855320|NCT00328627|BG000|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855321|NCT00328627|BG001|Baseline|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855322|NCT00328627|BG002|Baseline|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855323|NCT00328627|BG003|Baseline|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855324|NCT00328627|BG004|Baseline|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855325|NCT00328627|BG005|Baseline|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10976577|NCT00941070|OG000|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
10976578|NCT00941070|OG000|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin and undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression."
10976579|NCT00941070|OG000|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin and undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
10976580|NCT00941070|EG000|Reported Event|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
10976581|NCT00941304|BG000|Baseline|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
10976582|NCT00941304|BG001|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
10976583|NCT00941304|BG002|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
10976584|NCT00941304|BG003|Baseline|Placebo|Placebo oral capsule and 2 placebo buccal films
10976585|NCT00941304|BG004|Baseline|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
10976586|NCT00941304|BG005|Baseline|Total|Total of all reporting groups
10976587|NCT00941304|FG000|Participant Flow|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine hydrochloride (HCl) buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
10976588|NCT00941304|FG001|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
10976589|NCT00941304|FG002|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
10976590|NCT00941304|FG003|Participant Flow|Placebo|Placebo oral capsule and 2 placebo buccal films
10976591|NCT00941304|FG004|Participant Flow|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
10976592|NCT00941304|OG000|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
10976593|NCT00941304|OG001|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
10976594|NCT00941304|OG002|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
10976595|NCT00941304|OG003|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
10976596|NCT00941304|OG004|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
10976597|NCT00941304|EG000|Reported Event|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
10976598|NCT00941304|EG001|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
10976599|NCT00941304|EG002|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
10976600|NCT00941304|EG003|Reported Event|Placebo|Placebo oral capsule and 2 placebo buccal films
10976601|NCT00941304|EG004|Reported Event|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
10976602|NCT00941330|BG000|Baseline|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
10976603|NCT00941330|BG001|Baseline|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
10976604|NCT00941330|BG002|Baseline|Total|Total of all reporting groups
10976605|NCT00941330|FG000|Participant Flow|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
11345916|NCT04429932|OG005|Outcome|Product Variant F|MyBlu e-cigarette variant F (1.2% nicotine)
11345917|NCT04429932|OG006|Outcome|Product Variant G|MyBlu e-cigarette variant G (2.4% nicotine)
11345918|NCT04429932|OG007|Outcome|Product Variant H|MyBlu e-cigarette variant H (2.4% nicotine)
11345919|NCT04429932|OG000|Outcome|Exclusive MyBlu E-cigarette Use|Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
11345920|NCT04429932|EG000|Reported Event|Product Variant A|MyBlu e-cigarette variant A (2.4% nicotine)
11345921|NCT04429932|EG001|Reported Event|Product Variant B|MyBlu e- igarette variant B (2.4% nicotine)
11345922|NCT04429932|EG002|Reported Event|Product Variant C|MyBlu e-cigarette variant C (2.4% nicotine)
11345923|NCT04429932|EG003|Reported Event|Product Variant D|MyBlu e-cigarette variant D (2.4% nicotine)
11345924|NCT04429932|EG004|Reported Event|Product Variant E|MyBlu e- cigarette variant E (1.2% nicotine)
11345925|NCT04429932|EG005|Reported Event|Product Variant F|MyBlu e-cigarette variant F (1.2% nicotine)
11345926|NCT04429932|EG006|Reported Event|Product Variant G|MyBlu e-cigarette variant G (2.4% nicotine)
11345927|NCT04429932|EG007|Reported Event|Product Variant H|MyBlu e-cigarette variant H (2.4% nicotine)
11345928|NCT04428502|BG000|Baseline|Etanercept|Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.
11345929|NCT04428502|FG000|Participant Flow|Etanercept|Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.
11345930|NCT04428502|OG000|Outcome|Etanercept: ACCP Positive|Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status.
11345931|NCT04428502|OG001|Outcome|Etanercept: ACCP Negative|Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status.
11345932|NCT04428502|EG000|Reported Event|Etanercept|Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.
11345933|NCT04428424|BG000|Baseline|Etanercept|Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
11345934|NCT04428424|FG000|Participant Flow|Etanercept|Participants with rheumatoid arthritis (RA) and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
11345935|NCT04428424|OG000|Outcome|Etanercept|Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
11345936|NCT04428424|EG000|Reported Event|Etanercept|Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
11345937|NCT04428359|BG000|Baseline|Measles, Mumps, Rubella Vaccine|"All Group A patients will receive intralesional MMR.~Measles-Mumps-Rubella Vaccine: Group A patients will receive intralesional injection of upto 0.5 mL of reconstituted MMR vaccine into a single or a maximum of 5 warts at a time in case of multiple warts. Intralesional injection will be given every three weeks for a maximum of 5 doses or until complete resolution, whichever is earlier."
11345938|NCT04428359|BG001|Baseline|Vitamin D3|"All Group B patients will receive intralesional Vitamin D3~Vit D: Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier"
11345939|NCT04428359|BG002|Baseline|Total|Total of all reporting groups
11345940|NCT04428359|FG000|Participant Flow|Measles, Mumps, Rubella Vaccine|"All Group A patients will receive intralesional MMR.~Measles-Mumps-Rubella Vaccine: Group A patients will receive intralesional injection of upto 0.5 mL of reconstituted MMR vaccine into a single or a maximum of 5 warts at a time in case of multiple warts. Intralesional injection will be given every three weeks for a maximum of 5 doses or until complete resolution, whichever is earlier."
11345941|NCT04428359|FG001|Participant Flow|Vitamin D3|"All Group B patients will receive intralesional Vitamin D3~Vit D: Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier"
11345942|NCT04428359|OG000|Outcome|Measles, Mumps, Rubella Vaccine|"All Group A patients will receive intralesional MMR.~Measles-Mumps-Rubella Vaccine: Group A patients will receive intralesional injection of upto 0.5 mL of reconstituted MMR vaccine into a single or a maximum of 5 warts at a time in case of multiple warts. Intralesional injection will be given every three weeks for a maximum of 5 doses or until complete resolution, whichever is earlier."
11345943|NCT04428359|OG001|Outcome|Vitamin D3|"All Group B patients will receive intralesional Vitamin D3~Vit D: Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier"
11345944|NCT04428359|EG000|Reported Event|Measles, Mumps, Rubella Vaccine|"All Group A patients will receive intralesional MMR.~Measles-Mumps-Rubella Vaccine: Group A patients will receive intralesional injection of upto 0.5 mL of reconstituted MMR vaccine into a single or a maximum of 5 warts at a time in case of multiple warts. Intralesional injection will be given every three weeks for a maximum of 5 doses or until complete resolution, whichever is earlier."
11345945|NCT04428359|EG001|Reported Event|Vitamin D3|"All Group B patients will receive intralesional Vitamin D3~Vit D: Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier"
11345946|NCT04410159|BG000|Baseline|Povidone-iodine|"gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days~Povidone-Iodine: Gargle"
11345947|NCT04410159|BG001|Baseline|Essential Oils|"gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days~Essential oils: Gargle"
11222984|NCT02350127|FG001|Participant Flow|Delayed Start|Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
11345948|NCT04410159|BG002|Baseline|Tap Water|"gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days~Tap water: Gargle"
11345949|NCT04410159|BG003|Baseline|Control|This group received the standard treatment protocol without any additional intervention
11345950|NCT04410159|BG004|Baseline|Total|Total of all reporting groups
11345951|NCT04410159|FG000|Participant Flow|Povidone-iodine|"gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days~Povidone-Iodine: Gargle"
11345952|NCT04410159|FG001|Participant Flow|Essential Oils|"gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days~Essential oils: Gargle"
11345953|NCT04410159|FG002|Participant Flow|Tap Water|"gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days~Tap water: Gargle"
11345954|NCT04410159|FG003|Participant Flow|Control|This group will receive the standard treatment protocol without any additional intervention
11345955|NCT04410159|OG000|Outcome|Povidone-iodine|"gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days~Povidone-Iodine: Gargle"
11345956|NCT04410159|OG001|Outcome|Essential Oils|"gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days~Essential oils: Gargle"
11345957|NCT04410159|OG002|Outcome|Tap Water|"gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days~Tap water: Gargle"
11345958|NCT04410159|OG003|Outcome|Control|This group will receive the standard treatment protocol without any additional intervention
11345959|NCT04410159|EG000|Reported Event|Povidone-iodine|"gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days~Povidone-Iodine: Gargle"
11345960|NCT04410159|EG001|Reported Event|Essential Oils|"gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days~Essential oils: Gargle"
11345961|NCT04410159|EG002|Reported Event|Tap Water|"gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days~Tap water: Gargle"
11345962|NCT04410159|EG003|Reported Event|Control|This group will receive the standard treatment protocol without any additional intervention
11345963|NCT04425850|BG000|Baseline|IVER+|"Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. PPEs used as suggested by OMS.~iota carrageenan: topical use on nasal mucosae~Ivermectin: Topical use on oral mucosae"
10855326|NCT00328627|BG006|Baseline|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
11345964|NCT04425850|BG001|Baseline|IVER-|Same as IVER+ They will follow PPEs suggestions, only.
11345965|NCT04425850|BG002|Baseline|Total|Total of all reporting groups
11345966|NCT04425850|FG000|Participant Flow|IVER+|Standard prophylactic measures and PPEs + iota carrageenan (nasal and buccal) and ivermectin (buccal)
11345967|NCT04425850|FG001|Participant Flow|IVER-|Standard prophylactic measures and PPE only
11345968|NCT04425850|OG000|Outcome|IVER+|Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal)
11345969|NCT04425850|OG001|Outcome|IVER-|Standard prophylactic measures and PPEs only
11345970|NCT04425850|OG000|Outcome|IVER+|Standard prophylactic measures and PPE + Treatment with iota carragenan (nasal and buccal) and ivermectin (buccal only)
11345971|NCT04425850|OG001|Outcome|IVER-|Standard prophylactic measures and PPE only
11345972|NCT04425850|EG000|Reported Event|IVER+|Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal).
11345973|NCT04425850|EG001|Reported Event|IVER-|Standard prophylactic measures and PPEs only
11345974|NCT04425863|BG000|Baseline|Mild Cases|Patients diagnosed positive for COVID-19 and presenting only mild symptoms.
11345975|NCT04425863|BG001|Baseline|Moderate Cases|Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms
11345976|NCT04425863|BG002|Baseline|Severe Cases|Patients diagnosed positive for COVID-19 and presenting either 4 severe symptoms or 3 severe symptoms + not less than 2 mild symptoms or clinical symptoms of bilateral viral pneumonia
11345977|NCT04425863|BG003|Baseline|Total|Total of all reporting groups
11345978|NCT04425863|FG000|Participant Flow|Mild Cases|This group includes patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms such as: fever not above 38.5 °C; isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (93 - 96 %), dyspnea without matter, polymyoarthralgias, persistent headache, abdominal pain.
11345979|NCT04425863|FG001|Participant Flow|Moderate Cases|This group includes patients diagnosed positive for COVID-19 via rtPCR an presenting either: 3 severe symptoms (i.e. fever above 38.5 °C, diarrhea with more than 3 daily depositions, flictenular conjuntivitis, strong desaturation of 92 % or less, tachypnea with FR higher than 25/minute) or 2 severe symptoms + 2 mild symptoms (as already described for mild cases).
11345980|NCT04425863|FG002|Participant Flow|Severe Cases|This group includes patients diagnosed positive for COVID-19 via rtPCR and presenting either: 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms or clinical signs of bilateral viral pneumonia.
11345981|NCT04425863|OG000|Outcome|Mild Cases|Patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms. No clinical signs of viral pneumonia.
11345982|NCT04425863|OG001|Outcome|Moderate Cases|Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms. Clinical sign of viral pneumonia.
11345983|NCT04425863|OG002|Outcome|Severe Cases|Patient diagnosed positive for COVID-19 presenting 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms. Clinical signs of bilateral viral pneumonia.
11345984|NCT04425863|OG000|Outcome|Mild Cases|Patients diagnosed positive for COVID-19 via rtPCR, presenting only mild symptoms and no clinical sign of viral pneumonia.
11345985|NCT04425863|OG001|Outcome|Moderate Cases|Patients diagnosed positive for COVID-19 via rtPCR, presenting either 3 severe symptoms or 2 mild severe symptoms + 2 mild symptoms or clinical signs of viral pneumonia.
11345986|NCT04425863|OG002|Outcome|Severe Cases|Patients diagnosed positive for COVID-19, presenting either 4 severe symptoms or 3 severe symptoms + at least 2 mild symptoms or clinical signs of bilateral viral pneumonia
11345987|NCT04425863|OG000|Outcome|Mild Cases|Patients diagnosed positive for COVID-19 presenting only mild symptoms and no clinical signs of viral pneumonia.
11345988|NCT04425863|OG001|Outcome|Moderate Cases|Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe + 2 mild symptoms and showing clinical signs of viral pneumonia.
11345989|NCT04425863|OG002|Outcome|Severe Cases|Patients diagnosed positive for COVID-19 and presenting either 4 severe symptoms or 3 severe symptoms + 2 mild symptoms or clinical signs of bilateral viral pneumonia.
11345990|NCT04425863|OG000|Outcome|Mild Cases|Patients diagnosed positive for COVID-19 presenting only mild symptoms and no clinical sign of viral pneumonia.
11345991|NCT04425863|OG001|Outcome|Moderate Cases|Patients diagnosed positive for COVID-19 by rtPCR and presenting 3 severe symptoms or 2 mild + 2 severe symptoms or clinical signs of viral pneumonia.
11345992|NCT04425863|OG002|Outcome|Severe Cases|Patients diagnosed positive for COVID-19 by rtPCR and presenting 4 severe symptoms or 3 severe symptoms + 2 mild symptoms or clinical signs of bilateral viral pneumonia.
11345993|NCT04425863|OG000|Outcome|Mild Cases|Patients diagnosed positive for COVID-19 by rtPCR and presenting only mild symptoms and no clinical sign of viral pneumonia.
11345994|NCT04425863|OG001|Outcome|Moderate Cases|Patients diagnosed positive for COVID-19 by rtPCR and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms or clinical signs of viral pneumonia.
11345995|NCT04425863|OG002|Outcome|Severe Cases|Patients diagnosed positive for COVID-19 by rtPCR, presenting 4 sever symptoms, or 3 severe symptoms + 2 mild symptoms or clinical signs of bilateral viral pneumonia.
11345996|NCT04425863|EG000|Reported Event|Mild Cases|Patients diagnosed positive for COVID-19 presenting only mild symptoms and no clinical signs of viral pneumonia.
11345997|NCT04425863|EG001|Reported Event|Moderate Cases|Patients diagnosed positive for COVID-19 by rtPCR presenting 3 severe symptoms or 2 severe symptoms + 2 mild symptoms or clinical signs of viral pneumonia
11345998|NCT04425863|EG002|Reported Event|Severe Cases|Patients diagnosed positive for COVID-19 by rtPCR presenting 4 severe symptoms or 3 severe symptoms + 2 mild symptoms or clinical signs of bilateral viral pneumonia
11345999|NCT04425746|BG000|Baseline|Afamelanotide|Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication, and the results of evaluation of phototoxicity.
11346000|NCT04425746|BG001|Baseline|Placebo|Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
11346001|NCT04425746|BG002|Baseline|Total|Total of all reporting groups
11346002|NCT04425746|FG000|Participant Flow|Afamelanotide|Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication, and the results of evaluation of phototoxicity.
11346003|NCT04425746|FG001|Participant Flow|Placebo|Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
11346004|NCT04425746|OG000|Outcome|Afamelanotide|"Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.~Afamelanotide"
11346005|NCT04425746|OG001|Outcome|Placebo|"Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.~Placebo"
11346006|NCT04425746|OG000|Outcome|Afamelanotide|Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication, and the results of evaluation of phototoxicity.
11346007|NCT04425746|OG001|Outcome|Placebo|Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
11346008|NCT04425746|EG000|Reported Event|Afamelanotide|"Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.~Afamelanotide"
11346009|NCT04425746|EG001|Reported Event|Placebo|"Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.~Placebo"
11346010|NCT04422561|BG000|Baseline|Ivermectin Group|"Contacts who will receive prophylactic ivermectin~Ivermectin Tablets:~40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day)"
11346011|NCT04422561|BG001|Baseline|Control Group|Contacts who will be only observed without prophylaxis
11346012|NCT04422561|BG002|Baseline|Total|Total of all reporting groups
11346013|NCT04422561|FG000|Participant Flow|Ivermectin Group|"Contacts who will receive prophylactic ivermectin~Ivermectin Tablets:~40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day)"
11346014|NCT04422561|FG001|Participant Flow|Control Group|Contacts who will be only observed without prophylaxis
11346015|NCT04422561|OG000|Outcome|Ivermectin Group|"Contacts who will receive prophylactic ivermectin~Ivermectin Tablets:~40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day)"
11346016|NCT04422561|OG001|Outcome|Control Group|Contacts who will be only observed without prophylaxis
11346017|NCT04422561|EG000|Reported Event|Ivermectin Group|"Contacts who will receive prophylactic ivermectin~Ivermectin Tablets:~40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day)"
10855327|NCT00328627|BG007|Baseline|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855328|NCT00328627|BG008|Baseline|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855329|NCT00328627|BG009|Baseline|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855330|NCT00328627|BG010|Baseline|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
11346018|NCT04422561|EG001|Reported Event|Control Group|Contacts who will be only observed without prophylaxis
11348561|NCT04153409|FG001|Participant Flow|Placebo, Then LAT8881|Subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity.
10855331|NCT00328627|BG011|Baseline|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855332|NCT00328627|BG012|Baseline|Total|Total of all reporting groups
10855333|NCT00328627|FG000|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855334|NCT00328627|FG001|Participant Flow|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855335|NCT00328627|FG002|Participant Flow|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855336|NCT00328627|FG003|Participant Flow|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855337|NCT00328627|FG004|Participant Flow|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855338|NCT00328627|FG005|Participant Flow|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855339|NCT00328627|FG006|Participant Flow|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855340|NCT00328627|FG007|Participant Flow|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855341|NCT00328627|FG008|Participant Flow|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855342|NCT00328627|FG009|Participant Flow|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855343|NCT00328627|FG010|Participant Flow|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855344|NCT00328627|FG011|Participant Flow|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855345|NCT00328627|OG000|Outcome|Pioglitazone Alone|"Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Placebo + Pioglitazone 15 mg~Placebo + Pioglitazone 30 mg~Placebo + Pioglitazone 45 mg"
10855346|NCT00328627|OG001|Outcome|Alogliptin 12.5 + Pioglitazone|"Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Alogliptin 12.5 mg + Pioglitazone 15 mg~Alogliptin 12.5 mg + Pioglitazone 30 mg~Alogliptin 12.5 mg + Pioglitazone 45 mg"
10855347|NCT00328627|OG002|Outcome|Alogliptin 25 + Pioglitazone|"Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Alogliptin 25 mg + Pioglitazone 15 mg~Alogliptin 25 mg + Pioglitazone 30 mg~Alogliptin 25 mg + Pioglitazone 45 mg"
10855348|NCT00328627|OG000|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
10855349|NCT00328627|OG001|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
10855350|NCT00328627|OG002|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
10855351|NCT00328627|OG000|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855352|NCT00328627|OG001|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855353|NCT00328627|OG002|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855354|NCT00328627|OG003|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855355|NCT00328627|OG004|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855356|NCT00328627|OG005|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855357|NCT00328627|OG006|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855358|NCT00328627|OG007|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855359|NCT00328627|OG008|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
11222985|NCT02350127|OG000|Outcome|Immediate Start|The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
11346019|NCT04421404|BG000|Baseline|COVID-19 Convalescent Plasma|"Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.~COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined."
11346020|NCT04421404|BG001|Baseline|Placebo|"Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.~Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2."
11346021|NCT04421404|BG002|Baseline|Total|Total of all reporting groups
11346022|NCT04421404|FG000|Participant Flow|COVID-19 Convalescent Plasma|"Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.~COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined."
11346023|NCT04421404|FG001|Participant Flow|Placebo|"Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.~Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2."
11346024|NCT04421404|OG000|Outcome|COVID-19 Convalescent Plasma|"Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.~COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined."
11346025|NCT04421404|OG001|Outcome|Placebo|"Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.~Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2."
11346026|NCT04421404|EG000|Reported Event|COVID-19 Convalescent Plasma|"Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.~COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined."
11346027|NCT04421404|EG001|Reported Event|Placebo|"Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.~Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2."
11346028|NCT04419311|BG000|Baseline|Ultra-congruent Insert Group|Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.
11346029|NCT04419311|BG001|Baseline|Posterior Cruciate Ligament-stabilized Insert|Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
11346030|NCT04419311|BG002|Baseline|Total|Total of all reporting groups
11346031|NCT04419311|FG000|Participant Flow|Ultra-congruent Insert Group|Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.
11346032|NCT04419311|FG001|Participant Flow|Posterior Cruciate Ligament-stabilized Insert|Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
11346033|NCT04419311|OG000|Outcome|Ultra-congruent Insert Group|Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.
11346034|NCT04419311|OG001|Outcome|Posterior Cruciate Ligament-stabilized Insert|Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
11348562|NCT04153409|OG000|Outcome|Active|"Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.~LAT8881: Two 30 mg capsules of LAT8881"
11348563|NCT04153409|OG001|Outcome|Placebo|"Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.~Placebo: Two capsules of placebo"
11346035|NCT04419311|OG000|Outcome|Ultra-congruent Insert Group|"Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.~Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert."
11346036|NCT04419311|OG001|Outcome|Posterior Cruciate Ligament-stabilized Insert|"Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.~Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert."
11346037|NCT04419311|EG000|Reported Event|Ultra-congruent Insert Group|Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.
11346038|NCT04419311|EG001|Reported Event|Posterior Cruciate Ligament-stabilized Insert|Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
11346039|NCT04415489|BG000|Baseline|Office Hysteroscopy|"Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.~Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers."
11346040|NCT04415489|BG001|Baseline|Saline Infusion Sonography (SIS)|This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
11346041|NCT04415489|BG002|Baseline|Total|Total of all reporting groups
11346042|NCT04415489|FG000|Participant Flow|Office Hysteroscopy|"Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.~Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers."
11346043|NCT04415489|FG001|Participant Flow|Saline Infusion Sonography (SIS)|This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
11346044|NCT04415489|OG000|Outcome|Office Hysteroscopy|"Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.~Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers."
11346045|NCT04415489|OG001|Outcome|Saline Infusion Sonography (SIS)|This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
11346046|NCT04415489|OG000|Outcome|Saline Infusion Sonography (SIS)|This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
11346047|NCT04415489|EG000|Reported Event|Office Hysteroscopy|"Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.~Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers."
11346048|NCT04415489|EG001|Reported Event|Saline Infusion Sonography (SIS)|This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
11346049|NCT04411667|BG000|Baseline|Group A (Study Drug+SOC)|"Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.~Octagam: Standard of Care plus Octagam infusion for 3 days."
11346050|NCT04411667|BG001|Baseline|Group B (SOC)|Standard of Care
11346051|NCT04411667|BG002|Baseline|Total|Total of all reporting groups
11346052|NCT04411667|FG000|Participant Flow|Group A (Study Drug+SOC)|"Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.~Octagam: Standard of Care plus Octagam infusion for 3 days."
11346053|NCT04411667|FG001|Participant Flow|Group B (SOC)|Standard of Care
11346054|NCT04411667|OG000|Outcome|Group A (Study Drug+SOC)|"Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.~Octagam: Standard of Care plus Octagam infusion for 3 days."
11346055|NCT04411667|OG001|Outcome|Group B (SOC)|Standard of Care
11346056|NCT04411667|EG000|Reported Event|Group A (Study Drug+SOC)|"Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.~Octagam: Standard of Care plus Octagam infusion for 3 days."
11346057|NCT04411667|EG001|Reported Event|Group B (SOC)|Standard of Care
11346058|NCT04409886|BG000|Baseline|HBOT (Hyperbaric Oxygen Therapy)|"Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)~Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)"
11346059|NCT04409886|FG000|Participant Flow|HBOT (Hyperbaric Oxygen Therapy)|"Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)~Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)"
11346060|NCT04409886|OG000|Outcome|HBOT (Hyperbaric Oxygen Therapy)|"Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)~Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)"
11346061|NCT04409886|EG000|Reported Event|HBOT (Hyperbaric Oxygen Therapy)|"Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)~Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)"
11346062|NCT04407507|BG000|Baseline|Ivermectin|"Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days~Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days"
11346063|NCT04407507|BG001|Baseline|Placebo|"Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days~Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days"
11346064|NCT04407507|BG002|Baseline|Total|Total of all reporting groups
11346065|NCT04407507|FG000|Participant Flow|Ivermectin|"Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days~Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days"
11346066|NCT04407507|FG001|Participant Flow|Placebo|"Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days~Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days"
11346067|NCT04407507|OG000|Outcome|Ivermectin|"Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days~Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days"
11346068|NCT04407507|OG001|Outcome|Placebo|"Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days~Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days"
11346069|NCT04407507|EG000|Reported Event|Ivermectin|"Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days~Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days"
11346070|NCT04407507|EG001|Reported Event|Placebo|"Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days~Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days"
11346071|NCT04406194|BG000|Baseline|FAVICOVIR Then AVIGAN|Participants first received Favicovir 200 mg FT manufactured by Atabay in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state.
11346072|NCT04406194|BG001|Baseline|AVIGAN Then FAVICOVIR|Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state.
11346073|NCT04406194|BG002|Baseline|Total|Total of all reporting groups
11346074|NCT04406194|FG000|Participant Flow|Experimental: FAVICOVIR Then AVIGAN|Participants first received Favicovir 200 mg FT manufactured by Atabay in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state.
11346075|NCT04406194|FG001|Participant Flow|AVIGAN Then FAVICOVIR|Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state.
11346076|NCT04406194|OG000|Outcome|Favicovir 200 mg FT|Participants received single oral dose of 200 mg favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.
11346077|NCT04406194|OG001|Outcome|Avigan 200 mg FT|Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.
11346078|NCT04406194|OG000|Outcome|Favicovir 200 mg FT|Participants received single oral dose of 200 mg Favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.
11346079|NCT04406194|OG001|Outcome|Avigan 200 mg FT|Participants received single oral dose of 200 mg Favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.
11346080|NCT04406194|OG000|Outcome|Favicovir 200 mg FT|Participants received single dose of 200 mg Favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.
11346081|NCT04406194|EG000|Reported Event|FAVICOVIR 200 MG FT (Atabay-Turkey)|Participants received single oral dose of 200 favipiravir of Atabay-Turkey under fasting conditions.
11346082|NCT04406194|EG001|Reported Event|AVIGAN 200 MG FT (Toyama-Japan)|Participants received single oral dose of 200 favipiravir of Toyama-Japan under fasting conditions.
11346083|NCT04404907|BG000|Baseline|Males Who Never Deliberately Tan|Registry survey of males responded with a history of never deliberately (intentionallly) tanned
11346084|NCT04404907|BG001|Baseline|Males Who Ever Deliberately Tanned|Registry survey of males responded with a history of ever deliberately (intentionallly) tanned to make their skin appear darker
11346085|NCT04404907|BG002|Baseline|Total|Total of all reporting groups
11346086|NCT04404907|FG000|Participant Flow|Males Who Never Deliberately Tan|Registry survey of males responded with a history of never deliberately (intentionallly) tanned
11346087|NCT04404907|FG001|Participant Flow|Males Who Ever Deliberately Tanned|Registry survey of males responded with a history of ever deliberately (intentionallly) tanned to make their skin appear darker
11346088|NCT04404907|OG000|Outcome|Occasional Tanning|Males who deliberately (intentionally tanned) 2-10 times in 3 months
11346089|NCT04404907|OG001|Outcome|Frequent Tanning|Males who intentionally tanned 10 or more times in 3 months
11346090|NCT04404907|EG000|Reported Event|Males Who Never Deliberately Tan|No adverse events reported in the online survey of this group
10976606|NCT00941330|FG001|Participant Flow|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
10976607|NCT00941330|OG000|Outcome|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
10976608|NCT00941330|OG001|Outcome|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
10976609|NCT00941330|EG000|Reported Event|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
10976610|NCT00941330|EG001|Reported Event|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
11346091|NCT04404907|EG001|Reported Event|Males Who Ever Deliberately Tanned|No adverse events reported in the online survey of this group
11346092|NCT04404010|BG000|Baseline|Immersive Virtual Reality|"Participants randomized to the immersive virtual reality (iVR) study arm, considered the intervention group will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).~Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion."
11346093|NCT04404010|BG001|Baseline|Surgical Video|"Participants randomized to the standard video study arm, considered the control group will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.~Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion."
11346094|NCT04404010|BG002|Baseline|Total|Total of all reporting groups
11346095|NCT04404010|FG000|Participant Flow|Immersive Virtual Reality|"Participants randomized to the immersive virtual reality (iVR) study arm, considered the intervention group will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).~Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion."
11346096|NCT04404010|FG001|Participant Flow|Surgical Video|"Participants randomized to the standard video study arm, considered the control group will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.~Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion."
11348564|NCT04153409|EG000|Reported Event|Active|"Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.~LAT8881: Two 30 mg capsules of LAT8881"
11348565|NCT04153409|EG001|Reported Event|Placebo|"Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.~Placebo: Two capsules of placebo"
11348566|NCT04167189|BG000|Baseline|Hard-to-treat ADHD|Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack
10976611|NCT00941603|BG000|Baseline|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976612|NCT00941603|BG001|Baseline|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976613|NCT00941603|BG002|Baseline|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976614|NCT00941603|BG003|Baseline|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976615|NCT00941603|BG004|Baseline|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976616|NCT00941603|BG005|Baseline|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
10976617|NCT00941603|BG006|Baseline|Total|Total of all reporting groups
10976618|NCT00941603|FG000|Participant Flow|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976619|NCT00941603|FG001|Participant Flow|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976620|NCT00941603|FG002|Participant Flow|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976621|NCT00941603|FG003|Participant Flow|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976622|NCT00941603|FG004|Participant Flow|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976623|NCT00941603|FG005|Participant Flow|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
10976624|NCT00941603|OG000|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976625|NCT00941603|OG001|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976626|NCT00941603|OG002|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976627|NCT00941603|OG003|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976628|NCT00941603|OG004|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976629|NCT00941603|OG005|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
10976630|NCT00941603|EG000|Reported Event|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976631|NCT00941603|EG001|Reported Event|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976632|NCT00941603|EG002|Reported Event|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976633|NCT00941603|EG003|Reported Event|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976634|NCT00941603|EG004|Reported Event|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
10976635|NCT00941603|EG005|Reported Event|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
10976636|NCT00941655|BG000|Baseline|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
10976637|NCT00941655|BG001|Baseline|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
10976638|NCT00941655|BG002|Baseline|Total|Total of all reporting groups
10976639|NCT00941655|FG000|Participant Flow|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
11348567|NCT04167189|FG000|Participant Flow|Hard-to-treat ADHD|Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack
10976640|NCT00941655|FG001|Participant Flow|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
10976641|NCT00941655|OG000|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
10976642|NCT00941655|OG000|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
10976643|NCT00941655|OG001|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
11348568|NCT04167189|OG000|Outcome|Hard-to-treat ADHD|Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack
10976644|NCT00941655|EG000|Reported Event|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
10976645|NCT00941655|EG001|Reported Event|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
11346097|NCT04404010|OG000|Outcome|Immersive Virtual Reality|"Participants randomized to the immersive virtual reality (iVR) study arm, considered the intervention group will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).~Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion."
11346098|NCT04404010|OG001|Outcome|Surgical Video|"Participants randomized to the standard video study arm, considered the control group will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.~Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion."
11346099|NCT04404010|OG000|Outcome|Transfer of Training Ratio|A comparison of skill achievement compared to control performance. This informs how much skill is gained by training.
11346100|NCT04404010|OG000|Outcome|Transfer Effectiveness Ratio|Skill comparison relative to control, incorporating improvements in task time. This informs real world training reduction times.
11346101|NCT04404010|EG000|Reported Event|Immersive Virtual Reality|"Participants randomized to the immersive virtual reality (iVR) study arm, considered the intervention group will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).~Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion."
11346102|NCT04404010|EG001|Reported Event|Surgical Video|"Participants randomized to the standard video study arm, considered the control group will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.~Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion."
10976646|NCT00941668|BG000|Baseline|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
11346103|NCT04403399|BG000|Baseline|Varenicline Then Placebo|Patients will take varenicline initially for 3 weeks, then after a 3 week washout period, they will switch to placebo for 3 weeks.
11346104|NCT04403399|BG001|Baseline|Placebo Then Varenicline|Patients will take placebo initially for 3 weeks, then after a 3 week washout period, they will switch to varenicline for 3 weeks.
11346105|NCT04403399|BG002|Baseline|Total|Total of all reporting groups
11346106|NCT04403399|FG000|Participant Flow|Varenicline Then Placebo|Patients will take varenicline initially for 3 weeks, then after a 3 week washout period, they will switch to placebo for 3 weeks.
11346107|NCT04403399|FG001|Participant Flow|Placebo Then Varenicline|Patients will take placebo initially for 3 weeks, then after a 3 week washout period they will switch to varenicline for 3 weeks.
11346108|NCT04403399|OG000|Outcome|Varenicline|0.5 mg PO BID varenicline for 3 weeks (beginning with a 0.25 mg dose and escalated over the next 2 days)
11346109|NCT04403399|OG001|Outcome|Placebo|placebo given PO BID for 3 weeks
11346110|NCT04403399|EG000|Reported Event|Varenicline|0.5 mg PO BID varenicline for 3 weeks (beginning with a 0.25 mg dose and escalated over the next 2 days)
11346111|NCT04403399|EG001|Reported Event|Placebo|placebo given PO BID for 3 weeks
11346112|NCT04402970|BG000|Baseline|Inhaled/Nebulized Dornase Alfa|"Patient to receive inhaled/nebulized dornase alfa (Pulmozyme) 2.5 mg twice daily in the ventilator circuit for 3 days, along with standard of care for ARDS.~Dornase Alfa Inhalation Solution: Nebulized dornase alfa"
11346113|NCT04402970|BG001|Baseline|Standard of Care|Standard of care provided for ARDS.
10976647|NCT00941668|BG001|Baseline|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
10976648|NCT00941668|BG002|Baseline|Total|Total of all reporting groups
10976649|NCT00941668|FG000|Participant Flow|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
11346114|NCT04402970|BG002|Baseline|Total|Total of all reporting groups
11346115|NCT04402970|FG000|Participant Flow|Inhaled/Nebulized Dornase Alfa|"Patient to receive inhaled/nebulized dornase alfa (Pulmozyme) 2.5 mg twice daily in the ventilator circuit for 3 days, along with standard of care for ARDS.~Dornase Alfa Inhalation Solution: Nebulized dornase alfa"
11346116|NCT04402970|FG001|Participant Flow|Standard of Care|Standard of care provided for Acute Respiratory Distress Syndrome (ARDS)
10976650|NCT00941668|FG001|Participant Flow|Colgate Great Regular Flavor (Placebo)|sodium monofluorophosphate toothpaste
10976651|NCT00941668|OG000|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
10976652|NCT00941668|OG001|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
10976653|NCT00941668|EG000|Reported Event|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
10976654|NCT00941668|EG001|Reported Event|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
11346117|NCT04402970|OG000|Outcome|Inhaled/Nebulized Dornase Alfa|"Patient to receive inhaled/nebulized dornase alfa (Pulmozyme) 2.5 mg twice daily in the ventilator circuit for 3 days, along with standard of care for ARDS.~Dornase Alfa Inhalation Solution: Nebulized dornase alfa"
11346118|NCT04402970|OG001|Outcome|Standard of Care|Standard of care provided for ARDS.
11346119|NCT04402970|EG000|Reported Event|Inhaled/Nebulized Dornase Alfa|"Patient to receive inhaled/nebulized dornase alfa (Pulmozyme) 2.5 mg twice daily in the ventilator circuit for 3 days, along with standard of care for ARDS.~Dornase Alfa Inhalation Solution: Nebulized dornase alfa"
11346120|NCT04402970|EG001|Reported Event|Standard of Care|Standard of care provided for ARDS.
11346121|NCT04403113|BG000|Baseline|Study Group (SG)|"feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.~Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to"
11346122|NCT04403113|BG001|Baseline|Control Group (CG).|"feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program."
11346123|NCT04403113|BG002|Baseline|Total|Total of all reporting groups
11346124|NCT04403113|FG000|Participant Flow|Study Group (SG)|"feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.~Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to"
11346125|NCT04403113|FG001|Participant Flow|Control Group (CG).|"feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program."
11346126|NCT04403113|OG000|Outcome|Study Group (SG)|"feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.~Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding."
11346127|NCT04403113|OG001|Outcome|Control Group (CG).|"feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program."
11346128|NCT04403113|OG000|Outcome|Study Group (SG)|"feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding~Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding."
11348569|NCT04167189|EG000|Reported Event|Hard-to-treat ADHD|Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack
11348570|NCT04162795|BG000|Baseline|Loratadine Chewable Tablet|Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
10976655|NCT00941681|BG000|Baseline|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
11346129|NCT04403113|OG000|Outcome|Control Group (CG).|"feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program."
11346130|NCT04403113|OG001|Outcome|Study Group (SG)|"feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding~Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding."
11346131|NCT04403113|OG000|Outcome|Study Group (SG)|"feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding (Study Group)~Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program."
11346132|NCT04403113|EG000|Reported Event|Study Group (SG)|"feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding~Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding."
11346133|NCT04403113|EG001|Reported Event|Control Group (CG).|"feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)~Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.~Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program."
11346134|NCT04401202|BG000|Baseline|Nigella Sativa Oil|Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
11346135|NCT04401202|BG001|Baseline|Control|Standard of care
11346136|NCT04401202|BG002|Baseline|Total|Total of all reporting groups
11346137|NCT04401202|FG000|Participant Flow|Control|Standard of care
11346138|NCT04401202|FG001|Participant Flow|Nigella Sativa Oil|Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
11346139|NCT04401202|OG000|Outcome|Nigella Sativa Oil|Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
10976656|NCT00941681|BG001|Baseline|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
11346140|NCT04401202|OG001|Outcome|Control|Standard of care
11346141|NCT04401202|OG000|Outcome|Nigella Sativa Oil|"Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days~Nigella sativa oil: Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days"
11346142|NCT04401202|EG000|Reported Event|Nigella Sativa Oil|Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
11346143|NCT04401202|EG001|Reported Event|Control|Standard of care
11346144|NCT04400682|BG000|Baseline|FAVIRA Then AVIGAN|"Participants first received Favira 200 mg FT manufactured by Novelfarma in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./ Japan in a fasting state.~FAVIRA 200 MG FT: FAVIRA containing 200 mg favipiravir manufactured by Novelfarma, Turkey.~AVIGAN 200 mg FT: AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan"
11346145|NCT04400682|BG001|Baseline|AVIGAN Then FAVIRA|"Participants first received Avigan FT 200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favira 200 mg FT manufactured by Novelfarma in a fasting state.~FAVIRA 200 MG FT: FAVIRA containing 200 mg favipiravir manufactured by Novelfarma, Turkey.~AVIGAN 200 mg FT: AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan"
11346146|NCT04400682|BG002|Baseline|Total|Total of all reporting groups
11346147|NCT04400682|FG000|Participant Flow|FAVIRA Then AVIGAN|"Participants first received Favira 200 mg FT manufactured by Novelfarma in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./ Japan in a fasting state.~FAVIRA 200 MG FT: FAVIRA containing 200 mg favipiravir manufactured by Novelfarma, Turkey.~AVIGAN 200 mg FT: AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan"
11346148|NCT04400682|FG001|Participant Flow|AVIGAN Then FAVIRA|"Participants first received Avigan FT 200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favira 200 mg FT manufactured by Novelfarma in a fasting state.~FAVIRA 200 MG FT: FAVIRA containing 200 mg favipiravir manufactured by Novelfarma, Turkey.~AVIGAN 200 mg FT: AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan"
11346149|NCT04400682|OG000|Outcome|FAVIRA (Novelfarma-Turkey)|Participants received an oral single dose of 200 mg favipiravir (Novelfarma-Turkey) in fasting state.
11346150|NCT04400682|OG001|Outcome|AVIGAN (Toyama-Japan)|Participants received an oral single dose of 200 mg favipiravir (Toyama-Japan) in fasting state.
11346151|NCT04400682|EG000|Reported Event|FAVIRA (Novelfarma-Turkey)|Participants received an oral dose of 200 mg favipiravir (Novelfarma-Turkey) in fasting state.
11346152|NCT04400682|EG001|Reported Event|AVIGAN (Toyama-Japan|Participants received an oral dose of 200 mg favipiravir (Toyama-Japan) in fasting state.
11346153|NCT04399161|BG000|Baseline|Group A (Chlorhexidine Mouthrinse)|"A commercially available Chlorhexidine mouth rinse (Hexidine- 0.2 percentage Chlorhexidine gluconate) containing 0.2 percentage chlorhexidine gluconate per 10 ml was used. 7.5 ml of the concentrate diluted with equal amounts of water to make 15 ml was used for rinsing.~Children (5-12 years) at high risk for dental caries: 20~Elderly (above 60 years) at high risk for dental caries: 20"
11346154|NCT04399161|BG001|Baseline|Group B (Xylitol Mouth Rinse)|"Xylitol mouth rinse at 10 percentage concentration was used. The mouth rinse was prepared by dissolving 1.5 gm of xylitol powder in 15 ml of water.~Children (5-12 years) at high risk for dental caries: 20~Elderly (above 60 years) at high risk for dental caries: 20"
11346155|NCT04399161|BG002|Baseline|Group C (Probiotic Mouth Rinse)|"Probiotic mouth rinse was prepared by using a commercially available probiotic product (Sporolac Plus powder- 1gm sachet containing not less than 1.5 billion cells of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Bacillus coagulans, Saccharomyces boulardii). Each sachet was dissolved in 15 ml of water in a measuring cup and used as a mouth rinse.~Children (5-12 years) at high risk for dental caries: 20~Elderly (above 60 years) at high risk for dental caries: 20"
11346156|NCT04399161|BG003|Baseline|Total|Total of all reporting groups
11346157|NCT04399161|FG000|Participant Flow|Group A (Chlorhexidine Mouthrinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
11346158|NCT04399161|FG001|Participant Flow|Group B (Xylitol Mouth Rinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
11346159|NCT04399161|FG002|Participant Flow|Group C (Probiotic Mouth Rinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
11346160|NCT04399161|OG000|Outcome|Group A (Chlorhexidine Mouthrinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
11346161|NCT04399161|OG001|Outcome|Group B (Xylitol Mouth Rinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
11346162|NCT04399161|OG002|Outcome|Group C (Probiotic Mouth Rinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
11346163|NCT04399161|EG000|Reported Event|Group A (Chlorhexidine Mouthrinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
11346164|NCT04399161|EG001|Reported Event|Group B (Xylitol Mouth Rinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
11346165|NCT04399161|EG002|Reported Event|Group C (Probiotic Mouth Rinse)|Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
11346166|NCT04399980|BG000|Baseline|Intervention|One-time Mavrilimumab infusion at 6mg/kg via IV
11346167|NCT04399980|BG001|Baseline|Control|One-time placebo infusion via IV
11346168|NCT04399980|BG002|Baseline|Total|Total of all reporting groups
11346169|NCT04399980|FG000|Participant Flow|Intervention|One-time Mavrilimumab infusion at 6mg/kg via IV
11346170|NCT04399980|FG001|Participant Flow|Control|One-time placebo infusion via IV
11346171|NCT04399980|OG000|Outcome|Intervention|One-time Mavrilimumab infusion at 6mg/kg via IV
11346172|NCT04399980|OG001|Outcome|Control|One-time placebo infusion via IV
11346173|NCT04399980|EG000|Reported Event|Intervention|One-time Mavrilimumab infusion at 6kg/mg via IV
11346174|NCT04399980|EG001|Reported Event|Control|One-time placebo infusion via IV
11346175|NCT04399122|BG000|Baseline|Acetaminophen With Codeine|"codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery.~acetaminophen/codeine vs acetaminophen/oxycodone: pain medications"
10976657|NCT00941681|BG002|Baseline|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
11346176|NCT04399122|BG001|Baseline|Acetaminophen With Oxycodone|"oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery.~acetaminophen/codeine vs acetaminophen/oxycodone: pain medications"
11346177|NCT04399122|BG002|Baseline|Total|Total of all reporting groups
11346178|NCT04399122|FG000|Participant Flow|Acetaminophen With Codeine|"codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery.~acetaminophen/codeine vs acetaminophen/oxycodone: pain medications"
11346179|NCT04399122|FG001|Participant Flow|Acetaminophen With Oxycodone|"oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery.~acetaminophen/codeine vs acetaminophen/oxycodone: pain medications"
10976658|NCT00941681|BG003|Baseline|Total|Total of all reporting groups
10976659|NCT00941681|FG000|Participant Flow|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
11346180|NCT04399122|OG000|Outcome|Acetaminophen With Codeine|"codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery.~acetaminophen/codeine vs acetaminophen/oxycodone: pain medications"
11346181|NCT04399122|OG001|Outcome|Acetaminophen With Oxycodone|"oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery.~acetaminophen/codeine vs acetaminophen/oxycodone: pain medications"
11346182|NCT04399122|EG000|Reported Event|Acetaminophen With Codeine|"codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery.~acetaminophen/codeine vs acetaminophen/oxycodone: pain medications"
11346183|NCT04399122|EG001|Reported Event|Acetaminophen With Oxycodone|"oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery.~acetaminophen/codeine vs acetaminophen/oxycodone: pain medications"
11346184|NCT04397445|BG000|Baseline|All Participants|Participants were randomized to 1 of 4 treatment sequences (i.e., ABCD, BACD, ABDC, and BADC) and over 4 periods received ranitidine (300 mg) and placebo (randomized order) with a noncured-meats diet and then a cured-meats diet.
11346185|NCT04397445|FG000|Participant Flow|ABCD|"Participants first received a single dose of ranitidine, 300 mg, with a noncured meats diet designed to contain lower amounts of nitrites, nitrates (nitrate-reducing bacteria can convert nitrates to nitrites), and NDMA (Treatment A), then crossed over to the sequential treatments with one day of washout in between treatments.~Treatment B: Single dose of oral placebo with a noncured meats diet designed to contain lower amounts of nitrites, nitrates, and NDMA~Treatment C: Single dose of ranitidine, 300 mg with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA~Treatment D: Single dose of oral placebo with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA"
11346186|NCT04397445|FG001|Participant Flow|BACD|"Participants first received a single dose of oral placebo with a noncured meats diet designed to contain lower amounts of nitrites, nitrates (nitrate-reducing bacteria can convert nitrates to nitrites), and NDMA (Treatment B), then crossed over to the sequential treatments with one day of washout in between treatments.~Treatment A: Single dose of oral ranitidine, 300 mg, with a noncured meats diet designed to contain lower amounts of nitrites, nitrates, and NDMA~Treatment C: Single dose of ranitidine, 300 mg with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA~Treatment D: Single dose of oral placebo with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA"
11346187|NCT04397445|FG002|Participant Flow|ABDC|"Participants first received a single dose of ranitidine, 300 mg, with a noncured meats diet designed to contain lower amounts of nitrites, nitrates (nitrate-reducing bacteria can convert nitrates to nitrites), and NDMA (Treatment A), then crossed over to the sequential treatments with one day of washout in between treatments.~Treatment B: Single dose of oral placebo with a noncured meats diet designed to contain lower amounts of nitrites, nitrates, and NDMA~Treatment D: Single dose of oral placebo with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA~Treatment C: Single dose of ranitidine, 300 mg with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA"
11346188|NCT04397445|FG003|Participant Flow|BADC|"Participants first received a single dose of oral placebo with a noncured meats diet designed to contain lower amounts of nitrites, nitrates (nitrate-reducing bacteria can convert nitrates to nitrites), and NDMA (Treatment B), then crossed over to the sequential treatments with one day of washout in between treatments.~Treatment A: Single dose of oral ranitidine, 300 mg, with a noncured meats diet designed to contain lower amounts of nitrites, nitrates, and NDMA~Treatment D: Single dose of oral placebo with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA~Treatment C: Single dose of ranitidine, 300 mg with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA"
11346189|NCT04397445|OG000|Outcome|Ranitidine and Noncured Meats Diet|Single dose of ranitidine, 300 mg with a noncured meats diet designed to contain lower amounts of nitrites, nitrates, and NDMA
11346190|NCT04397445|OG001|Outcome|Placebo and Noncured Meats Diet|Single dose of oral placebo with a noncured meats diet designed to contain lower amounts of nitrites, nitrates, and NDMA
11346191|NCT04397445|OG002|Outcome|Ranitidine and Cured Meats Diet|Single dose of ranitidine, 300 mg with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA
11346192|NCT04397445|OG003|Outcome|Placebo and Cured Meats Diet|Single dose of oral placebo with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA
11346193|NCT04397445|OG000|Outcome|Ranitidine and Cured Meats Diet|Single dose of ranitidine, 300 mg with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA
11346194|NCT04397445|OG001|Outcome|Ranitidine and Noncured Meats Diet|Single dose of ranitidine, 300 mg with a noncured meats diet designed to contain lower amounts of nitrites, nitrates, and NDMA
11346195|NCT04397445|OG002|Outcome|Placebo and Cured Meats Diet|Single dose of oral placebo with a cured meats diet designed to contain higher amounts of nitrites, nitrates, and NDMA
11346196|NCT04397445|OG003|Outcome|Placebo and Noncured Meats Diet|Single dose of oral placebo with a noncured meats diet designed to contain lower amounts of nitrites, nitrates, and NDMA
11346197|NCT04397445|EG000|Reported Event|Lead-in (No Treatment)|Participants checked in one day early in order to standardize meals given the day prior to treatment start.
11346198|NCT04397445|EG001|Reported Event|Ranitidine and Noncured Meats Diet|"Single dose of ranitidine (300 mg) plus low nitrite/NDMA meals~Ranitidine: Ranitidine 300 mg~Low nitrite/NDMA meals: Meals containing low levels of nitrites and NDMA (noncured meats diet)"
10976660|NCT00941681|FG001|Participant Flow|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
10976661|NCT00941681|FG002|Participant Flow|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
10976662|NCT00941681|OG000|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
10976663|NCT00941681|OG001|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
11346199|NCT04397445|EG002|Reported Event|Placebo and Noncured Meats Diet|"Single dose of placebo plus low nitrite/NDMA meals~Placebo: Oral placebo tablet~Low nitrite/NDMA meals: Meals containing low levels of nitrites and NDMA (noncured meats diet)"
11346200|NCT04397445|EG003|Reported Event|Ranitidine and Cured Meats Diet|"Single dose of ranitidine (300 mg) plus high nitrite/NDMA meals~Ranitidine: Ranitidine 300 mg~High nitrite/NDMA meals: Meals containing higher levels of nitrites and NDMA (cured meats diet)"
11346201|NCT04397445|EG004|Reported Event|Placebo and Cured Meats Diet|"Single dose of placebo plus high nitrite/NDMA meals~Placebo: Oral placebo tablet~High nitrite/NDMA meals: Meals containing higher levels of nitrites and NDMA (cured meats diet)"
11346202|NCT04397094|BG000|Baseline|Theracal LC|"Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Theracal LC: pulpotomy"
11346203|NCT04397094|BG001|Baseline|Formocresol|"Formocresol (1/5 th concentration) was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Formocresol: Pulpotomy"
11346204|NCT04397094|BG002|Baseline|Total|Total of all reporting groups
11346205|NCT04397094|FG000|Participant Flow|Theracal LC|"Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Theracal LC: pulpotomy"
11346206|NCT04397094|FG001|Participant Flow|Formocresol|"Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Formocresol: Pulpotomy"
11346207|NCT04397094|OG000|Outcome|Theracal LC|"Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Theracal LC: pulpotomy~NO clinical failures was evident over the 12 months follow up"
11346208|NCT04397094|OG001|Outcome|Formocresol|"Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Formocresol: Pulpotomy~NO clinical failures was evident over the 12 months follow up"
11346209|NCT04397094|OG000|Outcome|Theracal LC|"Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Theracal LC: pulpotomy"
11346210|NCT04397094|OG001|Outcome|Formocresol|"Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Formocresol: Pulpotomy"
11346211|NCT04397094|EG000|Reported Event|Theracal LC|"Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Theracal LC: pulpotomy"
11346212|NCT04397094|EG001|Reported Event|Formocresol|"Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.~Formocresol: Pulpotomy"
11346213|NCT04396639|BG000|Baseline|Moroctocog Alfa (AF-CC)|Moroctocog alfa was administered prophylactically at a dose of 30 IU/kg, 3 times weekly in accordance with local product document and with procedures provided by physicians. For on-demand treatment, the amount administered and the frequency of administration of moroctocog alfa was tailored to the clinical effectiveness in individual participants by their physicians. Participants continued participating in the study until 24 exposure days or until 8 weeks of treatment (whichever occurred first). Post treatment participants were followed up to 28 days.
11346214|NCT04396639|FG000|Participant Flow|Moroctocog Alfa (AF-CC)|Moroctocog alfa was administered prophylactically at a dose of 30 international unit per kilogram (IU/kg), 3 times weekly in accordance with local product document and with procedures provided by physicians. For on-demand treatment, the amount administered and the frequency of administration of moroctocog alfa was tailored to the clinical effectiveness in individual participants by their physicians. Participants continued participating in the study until 24 exposure days or until 8 weeks of treatment (whichever occurred first). Post treatment participants were followed up to 28 days.
11346215|NCT04396639|OG000|Outcome|Moroctocog Alfa (AF-CC)|Moroctocog alfa was administered prophylactically at a dose of 30 IU/kg, 3 times weekly in accordance with local product document and with procedures provided by physicians. For on-demand treatment, the amount administered and the frequency of administration of moroctocog alfa was tailored to the clinical effectiveness in individual participants by their physicians. Participants continued participating in the study until 24 exposure days or until 8 weeks of treatment (whichever occurred first). Post treatment participants were followed up to 28 days.
10855360|NCT00328627|OG009|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855361|NCT00328627|OG010|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855362|NCT00328627|OG011|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855363|NCT00328627|OG007|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855364|NCT00328627|OG009|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855365|NCT00328627|EG000|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855366|NCT00328627|EG001|Reported Event|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855367|NCT00328627|EG002|Reported Event|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10855368|NCT00328627|EG003|Reported Event|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10976664|NCT00941681|OG002|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
11346216|NCT04396639|EG000|Reported Event|Moroctocog Alfa (AF-CC)|Moroctocog alfa was administered prophylactically at a dose of 30 IU/kg, 3 times weekly in accordance with local product document and with procedures provided by physicians. For on-demand treatment, the amount administered and the frequency of administration of moroctocog alfa was tailored to the clinical effectiveness in individual participants by their physicians. Participants continued participating in the study until 24 exposure days or until 8 weeks of treatment (whichever occurred first). Post treatment participants were followed up to 28 days.
11346217|NCT04396665|BG000|Baseline|Intervention Group|Women in the Intervention group
11346218|NCT04396665|BG001|Baseline|Control Group|Women in the Control group
11346219|NCT04396665|BG002|Baseline|Total|Total of all reporting groups
11346220|NCT04396665|FG000|Participant Flow|Precam Group (Intervention Group)|"150 Women without breast cancer, aged from 25 to 50 years old~Precam: 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention"
11346221|NCT04396665|FG001|Participant Flow|Control Group|150 Women without breast cancer, aged from 25 to 50 years old
11346222|NCT04396665|OG000|Outcome|Intervention Group|Women in the intervention group
11346223|NCT04396665|OG001|Outcome|Control Group|Women in the control group
11346224|NCT04396665|OG000|Outcome|Intervention|Women in the intervention group
11346225|NCT04396665|OG001|Outcome|Control|Women in the control group
11346226|NCT04396665|OG000|Outcome|Intervention Group|"150 Women without breast cancer, aged from 25 to 50 years old~Precam: 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention"
11346227|NCT04396665|OG001|Outcome|Control Group|150 Women without breast cancer, aged from 25 to 50 years old
11346228|NCT04396665|EG000|Reported Event|Intervention Group|Women in the Intervention group
11346229|NCT04396665|EG001|Reported Event|Control Group|Women in the Control group
11346230|NCT04393493|BG000|Baseline|Stepped Furosemide|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution~Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution~Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution~Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution"
11346231|NCT04393493|BG001|Baseline|Diuretics Combined|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs."
11346232|NCT04393493|BG002|Baseline|Total|Total of all reporting groups
11346233|NCT04393493|FG000|Participant Flow|Stepped Furosemide|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution~Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution~Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution~Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution"
11346234|NCT04393493|FG001|Participant Flow|Diuretics Combined|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.~Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.~Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.~Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs."
11346235|NCT04393493|OG000|Outcome|Stepped Furosemide|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution~Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution~Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution~Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution"
11346236|NCT04393493|OG001|Outcome|Diuretics Combined|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs."
11346237|NCT04393493|OG000|Outcome|Stepped Furosemide|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution~Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution~Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution~Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution"
11348571|NCT04162795|FG000|Participant Flow|Loratadine Chewable Tablet|Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
11348572|NCT04162795|OG000|Outcome|Loratadine Chewable Tablet|Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
10976665|NCT00941681|EG000|Reported Event|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
10976666|NCT00941681|EG001|Reported Event|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
10976667|NCT00941681|EG002|Reported Event|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
11346238|NCT04393493|OG001|Outcome|Diuretics Combined|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.~Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 50mg orally every 24 hrs.~Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 50 orally every 24 hrs.~Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 50mg orally every 24 hrs."
11346239|NCT04393493|EG000|Reported Event|Stepped Furosemide|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution~Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution~Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution~Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution"
11346240|NCT04393493|EG001|Reported Event|Diuretics Combined|"Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs."
11346241|NCT04392362|BG000|Baseline|Simplified Method|"Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush~Adenosine: A vial of adenosine with 6mg"
11346242|NCT04392362|BG001|Baseline|AHA Method|"Giving adenosine Ising the recommended AHA two syringe method~Adenosine: A vial of adenosine with 6mg"
11346243|NCT04392362|BG002|Baseline|Total|Total of all reporting groups
11346244|NCT04392362|FG000|Participant Flow|Intervention/SIM Group|"Giving adenosine 6mg premixed with saline flush to a total of 20ml and giving it as a rapid flush, then same method repeated twice with 12 mg adenosine if the SVT does not convert~The group evaluated was the SIM or intervention group"
10845405|NCT00266877|BG002|Baseline|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845406|NCT00266877|BG003|Baseline|Total|Total of all reporting groups
10845407|NCT00266877|FG000|Participant Flow|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845408|NCT00266877|FG001|Participant Flow|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845409|NCT00266877|FG002|Participant Flow|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845410|NCT00266877|OG000|Outcome|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845411|NCT00266877|OG001|Outcome|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845412|NCT00266877|OG002|Outcome|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845413|NCT00266877|EG000|Reported Event|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845414|NCT00266877|EG001|Reported Event|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845415|NCT00266877|EG002|Reported Event|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
10845416|NCT00267007|BG000|Baseline|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
10845417|NCT00267007|BG001|Baseline|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
10855369|NCT00328627|EG004|Reported Event|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855370|NCT00328627|EG005|Reported Event|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
10855371|NCT00328627|EG006|Reported Event|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855372|NCT00328627|EG007|Reported Event|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855373|NCT00328627|EG008|Reported Event|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10855374|NCT00328627|EG009|Reported Event|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855375|NCT00328627|EG010|Reported Event|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855376|NCT00328627|EG011|Reported Event|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
10855377|NCT00328770|BG000|Baseline|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
10855378|NCT00328770|FG000|Participant Flow|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
10855379|NCT00328770|OG000|Outcome|Patient Survival|1 and 4 year patient survival
10855380|NCT00328770|OG000|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
10855381|NCT00328770|EG000|Reported Event|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
10855382|NCT00328783|BG000|Baseline|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
10855383|NCT00328783|FG000|Participant Flow|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
10855384|NCT00328783|OG000|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
10855385|NCT00328783|OG000|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
10855386|NCT00328783|OG000|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.~Radiation Therapy"
10855387|NCT00328783|EG000|Reported Event|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
10855388|NCT00328861|BG000|Baseline|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
10855389|NCT00328861|BG001|Baseline|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
10855390|NCT00328861|BG002|Baseline|Total|Total of all reporting groups
10855391|NCT00328861|FG000|Participant Flow|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
10855392|NCT00328861|FG001|Participant Flow|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
10855393|NCT00328861|OG000|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
10855394|NCT00328861|OG001|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
10855395|NCT00328861|EG000|Reported Event|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
10845418|NCT00267007|BG002|Baseline|Total|Total of all reporting groups
10845419|NCT00267007|FG000|Participant Flow|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
10845420|NCT00267007|FG001|Participant Flow|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
10845421|NCT00267007|OG000|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
10845422|NCT00267007|OG001|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
10845423|NCT00267007|EG000|Reported Event|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
10845424|NCT00267007|EG001|Reported Event|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
10845425|NCT00267020|BG000|Baseline|Enzastaurin+Gemcitabine|"Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.~Gemcitabine: 1000 milligrams/square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle."
10845426|NCT00267020|BG001|Baseline|Gemcitabine|Gemcitabine: 1000 mg/m^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.
10845427|NCT00267020|BG002|Baseline|Total|Total of all reporting groups
10845428|NCT00267020|FG000|Participant Flow|Enzastaurin+Gemcitabine|"Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.~Gemcitabine: 1000 milligrams/square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle."
10845429|NCT00267020|FG001|Participant Flow|Gemcitabine|Gemcitabine: 1000 milligrams/square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.
10845430|NCT00267020|OG000|Outcome|Enzastaurin+Gemcitabine|"Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.~Gemcitabine: 1000 milligrams/square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle."
10845431|NCT00267020|OG001|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.
10845432|NCT00267020|EG000|Reported Event|Enzastaurin+Gemcitabine|"Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.~Gemcitabine: 1000 milligrams/square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle."
10845433|NCT00267020|EG001|Reported Event|Gemcitabine|Gemcitabine: 1000 mg/m^2 administered intravenously on Days 1, 8 and 15 of each of each 28-day cycle.
10845434|NCT00267046|BG000|Baseline|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
10845435|NCT00267046|BG001|Baseline|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
10845436|NCT00267046|BG002|Baseline|Total|Total of all reporting groups
10845437|NCT00267046|FG000|Participant Flow|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
10845438|NCT00267046|FG001|Participant Flow|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
10845439|NCT00267046|OG000|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
10845440|NCT00267046|OG001|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
10855396|NCT00328861|EG001|Reported Event|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
10855397|NCT00328926|BG000|Baseline|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855398|NCT00328926|BG001|Baseline|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855399|NCT00328926|BG002|Baseline|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855400|NCT00328926|BG003|Baseline|Total|Total of all reporting groups
10855401|NCT00328926|FG000|Participant Flow|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855402|NCT00328926|FG001|Participant Flow|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855403|NCT00328926|FG002|Participant Flow|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855404|NCT00328926|OG000|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855405|NCT00328926|OG001|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
11348573|NCT04162795|EG000|Reported Event|Loratadine Chewable Tablet|Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
10855406|NCT00328926|OG002|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855407|NCT00328926|EG000|Reported Event|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855408|NCT00328926|EG001|Reported Event|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855409|NCT00328926|EG002|Reported Event|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
10855410|NCT00329030|BG000|Baseline|B-BEAM|Bexxar/BEAM
10855411|NCT00329030|BG001|Baseline|R-BEAM|Rituxan/BEAM
10855412|NCT00329030|BG002|Baseline|Total|Total of all reporting groups
10855413|NCT00329030|FG000|Participant Flow|B-BEAM|Patients received Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive carmustine (BCNU) 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
10855414|NCT00329030|FG001|Participant Flow|R-BEAM|Patients received Rituxan/BEAM, with Rituxan 375 mg/m2 IV Days -19 and -12, BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
10855415|NCT00329030|OG000|Outcome|B-BEAM|Bexxar/BEAM
10855416|NCT00329030|OG001|Outcome|R-BEAM|Rituxan/BEAM
10855417|NCT00329030|EG000|Reported Event|B-BEAM|Bexxar/BEAM
10855418|NCT00329030|EG001|Reported Event|R-BEAM|Rituxan/BEAM
10855419|NCT00329160|BG000|Baseline|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
10855420|NCT00329160|FG000|Participant Flow|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
10855421|NCT00329160|OG000|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
10855422|NCT00329160|EG000|Reported Event|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
10855423|NCT00329238|BG000|Baseline|Dabigatran|150 mg twice daily, total daily dose 300 mg
10855424|NCT00329238|BG001|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
10855425|NCT00329238|BG002|Baseline|Total|Total of all reporting groups
10855426|NCT00329238|FG000|Participant Flow|Dabigatran|150 mg twice daily, total daily dose 300 mg
10855427|NCT00329238|FG001|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
10855428|NCT00329238|OG000|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
10855429|NCT00329238|OG001|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
10855430|NCT00329238|EG000|Reported Event|Dabigatran|150 mg twice daily, total daily dose 300 mg
10855431|NCT00329238|EG001|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
10855432|NCT00329238|EG002|Reported Event|Post Dabigatran|
10855433|NCT00329238|EG003|Reported Event|Post Warfarin|
10855434|NCT00329303|BG000|Baseline|Certolizumab Pegol (CZP) 200 mg|Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter
10855435|NCT00329303|BG001|Baseline|Certolizumab Pegol (CZP) 400 mg|Subcutaneous injections of 400 mg every 2 weeks
10855436|NCT00329303|BG002|Baseline|Total Title|
10855437|NCT00329303|FG000|Participant Flow|Certolizumab Pegol (CZP) 200 mg|Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter
10855438|NCT00329303|FG001|Participant Flow|Certolizumab Pegol (CZP) 400 mg|Subcutaneous injections of 400 mg every 2 weeks
10855439|NCT00329303|OG000|Outcome|Certolizumab Pegol (CZP) 200 mg|Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter
10855440|NCT00329303|OG001|Outcome|Certolizumab Pegol (CZP) 400 mg|Subcutaneous injections of 400 mg every 2 weeks
10855441|NCT00329303|OG000|Outcome|Certolizumab Pegol (CZP) 200 mg|Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
10855442|NCT00329303|EG000|Reported Event|Certolizumab Pegol (CZP) 200 mg|Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter
10855443|NCT00329303|EG001|Reported Event|Certolizumab Pegol (CZP) 400 mg|Subcutaneous injections of 400 mg every 2 weeks
10855444|NCT00329407|BG000|Baseline|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
10855445|NCT00329407|FG000|Participant Flow|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
10855446|NCT00329407|OG000|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
10855447|NCT00329407|EG000|Reported Event|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
10855448|NCT00329420|BG000|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855449|NCT00329420|BG001|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855450|NCT00329420|BG002|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855451|NCT00329420|BG003|Baseline|Total|Total of all reporting groups
10855452|NCT00329420|FG000|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855453|NCT00329420|FG001|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855454|NCT00329420|FG002|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855455|NCT00329420|OG000|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855456|NCT00329420|OG001|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855457|NCT00329420|OG002|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855458|NCT00329420|EG000|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855459|NCT00329420|EG001|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855460|NCT00329420|EG002|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855461|NCT00329420|EG003|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 46 subjects who entered this extension study.
10855462|NCT00329420|EG004|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (N00291668) and this extension study for all 46 subjects who entered this extension study C87048, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
10855463|NCT00329433|BG000|Baseline|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
10855464|NCT00329433|BG001|Baseline|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
10855465|NCT00329433|BG002|Baseline|Total|Total of all reporting groups
10855466|NCT00329433|FG000|Participant Flow|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
10855467|NCT00329433|FG001|Participant Flow|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
10855468|NCT00329433|OG000|Outcome|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
10855469|NCT00329433|OG001|Outcome|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
10855470|NCT00329433|EG000|Reported Event|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
10855471|NCT00329433|EG001|Reported Event|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
10855472|NCT00329524|BG000|Baseline|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
10855473|NCT00329524|FG000|Participant Flow|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
10855474|NCT00329524|OG000|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
10855475|NCT00329524|EG000|Reported Event|Active Versus Sham Treatment|"Subjects randomly assigned to active and sham TMS separated by one week interval.~Repetitive Transcranial Magnetic Stimulation (rTMS): TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectiv"
10855476|NCT00329550|BG000|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855477|NCT00329550|BG001|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855478|NCT00329550|BG002|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855479|NCT00329550|BG003|Baseline|Total|Total of all reporting groups
10855480|NCT00329550|FG000|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855481|NCT00329550|FG001|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855482|NCT00329550|FG002|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855483|NCT00329550|OG000|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855484|NCT00329550|OG001|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855485|NCT00329550|OG002|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855486|NCT00329550|EG000|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855487|NCT00329550|EG001|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855488|NCT00329550|EG002|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
10855489|NCT00329550|EG003|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 40 subjects who entered this extension study.
10855490|NCT00329550|EG004|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (NCT00291668) and this extension study for all 40 subjects who entered this extension study, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
10855491|NCT00329602|BG000|Baseline|Double-Blind Placebo|Matching placebo tablets
10855492|NCT00329602|BG001|Baseline|Double-Blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855493|NCT00329602|BG002|Baseline|Total|Total of all reporting groups
10855494|NCT00329602|FG000|Participant Flow|Double-blind Placebo|Matching placebo tablets
10855495|NCT00329602|FG001|Participant Flow|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855496|NCT00329602|FG002|Participant Flow|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855497|NCT00329602|OG000|Outcome|Double-blind Placebo|Matching placebo tablets
10855498|NCT00329602|OG001|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855499|NCT00329602|OG000|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855500|NCT00329602|OG000|Outcome|Overall Study|
10855501|NCT00329602|OG001|Outcome|Double-blind Placebo|Matching placebo tablets
10855502|NCT00329602|OG002|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855503|NCT00329602|OG003|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855504|NCT00329602|OG000|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not in the center groups with the highest or lowest treatment effects
10855505|NCT00329602|OG001|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not in the center groups with the highest or lowest treatment effects
10855506|NCT00329602|OG000|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not excluded from the IRLS post-hoc analysis
10855507|NCT00329602|OG001|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not excluded from the IRLS post-hoc analysis
10855508|NCT00329602|EG000|Reported Event|Double-blind Placebo|Matching placebo tablets
10855509|NCT00329602|EG001|Reported Event|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855510|NCT00329602|EG002|Reported Event|Open-Label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
10855511|NCT00329641|BG000|Baseline|Sorafenib, Carboplatin, Paclitaxel|
10855512|NCT00329641|FG000|Participant Flow|Sorafenib, Carboplatin, Paclitaxel|Standard carboplatin and paclitaxel doses with the addition of sorafenib (800 mg daily)
10855513|NCT00329641|OG000|Outcome|Sorafenib, Carboplatin, Paclitaxel|
10855514|NCT00329641|OG000|Outcome|Intervention|Sorafenib, Carboplatin, Paclitaxel
10855515|NCT00329641|EG000|Reported Event|Intervention|Sorafenib, Carboplatin, Paclitaxel
10855516|NCT00329719|BG000|Baseline|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855517|NCT00329719|BG001|Baseline|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855518|NCT00329719|BG002|Baseline|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
10855519|NCT00329719|BG003|Baseline|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855520|NCT00329719|BG004|Baseline|Total|Total of all reporting groups
10855521|NCT00329719|FG000|Participant Flow|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855522|NCT00329719|FG001|Participant Flow|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855523|NCT00329719|FG002|Participant Flow|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
11346245|NCT04392362|FG001|Participant Flow|Control/AHA Group|"Giving adenosine as 6mg in one syringe with a separate syringe with 20ml saline flush using a three way stop cock to connect the syringes. Adenosine is given first as a rapid push followed by another rapid flush from the saline. The same method to be repeated twice with 12 mg adenosine if the SVT does not convert after 10-15 seconds~The group evaluated was the AHA or control group"
11346246|NCT04392362|OG000|Outcome|Intervention Group|"Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush~Adenosine: A vial of adenosine with 6mg"
11346247|NCT04392362|OG001|Outcome|Control Group|"Giving adenosine Ising the recommended AHA two syringe method~Adenosine: A vial of adenosine with 6mg"
11346248|NCT04392362|EG000|Reported Event|Intervention Group|"Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush~Adenosine: A vial of adenosine with 6mg"
11346249|NCT04392362|EG001|Reported Event|Control Group|"Giving adenosine Ising the recommended AHA two syringe method~Adenosine: A vial of adenosine with 6mg"
11346250|NCT04392141|BG000|Baseline|Standard Treatment|"Patients diagnosed with COVID-19 which receive the standard treatment national guideline~Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations"
11346251|NCT04392141|BG001|Baseline|Colchicine and Herbal Phenolic Monoterpene Fractions|"Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions~Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions: Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19."
11346252|NCT04392141|BG002|Baseline|Total|Total of all reporting groups
11346253|NCT04392141|FG000|Participant Flow|Standard Treatment|"Patients diagnosed with COVID-19 which receive the standard treatment national guideline~Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations"
11346254|NCT04392141|FG001|Participant Flow|Colchicine and Herbal Phenolic Monoterpene Fractions|"Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions~Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions: Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19."
11346255|NCT04392141|OG000|Outcome|Standard Treatment|"Patients diagnosed with COVID-19 which receive the standard treatment national guideline~Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations"
11346256|NCT04392141|OG001|Outcome|Colchicine and Herbal Phenolic Monoterpene Fractions|"Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions~Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions: Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19."
10976668|NCT00941720|BG000|Baseline|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
11346257|NCT04392141|EG000|Reported Event|Standard Treatment|"Patients diagnosed with COVID-19 which receive the standard treatment national guideline~Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations"
11346258|NCT04392141|EG001|Reported Event|Colchicine and Herbal Phenolic Monoterpene Fractions|"Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions~Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions: Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19."
11346259|NCT04392219|BG000|Baseline|Part 1 - Placebo|Participants were randomized to receive a single oral dose of Placebo (fasted).
11346260|NCT04392219|BG001|Baseline|Part 1 - 50 mg EIDD-2801|Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).
11346261|NCT04392219|BG002|Baseline|Part 1 - 100 mg EIDD-2801|Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).
11346262|NCT04392219|BG003|Baseline|Part 1 - 200 mg EIDD-2801|Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).
11346263|NCT04392219|BG004|Baseline|Part 1 - 400 mg EIDD-2801|Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).
11346264|NCT04392219|BG005|Baseline|Part 1 - 600 mg EIDD-2801|Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).
11346265|NCT04392219|BG006|Baseline|Part 1 - 800 mg EIDD-2801|Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).
11346266|NCT04392219|BG007|Baseline|Part 1 - 1200 mg EIDD-2801|Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).
11346267|NCT04392219|BG008|Baseline|Part 1 - 1600 mg EIDD-2801|Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).
11346268|NCT04392219|BG009|Baseline|Part 2 - 200 mg EIDD-2801 (Fasted/Fed)|Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed).
11346269|NCT04392219|BG010|Baseline|Part 3 - Placebo|Participants were randomized to receive two daily dosing of Placebo capsules (fasted).
11346270|NCT04392219|BG011|Baseline|Part 3 - 50 mg EIDD-2801|Participants were randomized to receive two daily dosing of 50 mg EIDD-2801 capsules (fasted).
11346271|NCT04392219|BG012|Baseline|Part 3 - 100 mg EIDD-2801|Participants were randomized to receive two daily dosing of 100 mg EIDD-2801 capsules (fasted).
11346272|NCT04392219|BG013|Baseline|Part 3 - 200 mg EIDD-2801|Participants were randomized to receive two daily dosing of 200 mg EIDD-2801 capsules (fasted).
11346273|NCT04392219|BG014|Baseline|Part 3 - 300 mg EIDD-2801|Participants were randomized to receive two daily dosing of 300 mg EIDD-2801 capsules (fasted).
11346274|NCT04392219|BG015|Baseline|Part 3 - 400 mg EIDD-2801|Participants were randomized to receive two daily dosing of 400 mg EIDD-2801 capsules (fasted).
11346275|NCT04392219|BG016|Baseline|Part 3 - 600 mg EIDD-2801|Participants were randomized to receive two daily dosing of 600 mg EIDD-2801 capsules (fasted).
11346276|NCT04392219|BG017|Baseline|Part 3 - 800 mg EIDD-2801|Participants were randomized to receive two daily dosing of 800 mg EIDD-2801 capsules (fasted).
11346277|NCT04392219|BG018|Baseline|Total|Total of all reporting groups
11346278|NCT04392219|FG000|Participant Flow|Part 1 - Placebo|Participants were randomized to receive a single oral dose of Placebo (fasted).
11346279|NCT04392219|FG001|Participant Flow|Part 1 - 50 mg EIDD-2801|Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).
11346280|NCT04392219|FG002|Participant Flow|Part 1 - 100 mg EIDD-2801|Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).
11346281|NCT04392219|FG003|Participant Flow|Part 1 - 200 mg EIDD-2801|Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).
11346282|NCT04392219|FG004|Participant Flow|Part 1 - 400 mg EIDD-2801|Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).
11346283|NCT04392219|FG005|Participant Flow|Part 1 - 600 mg EIDD-2801|Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).
11346284|NCT04392219|FG006|Participant Flow|Part 1 - 800 mg EIDD-2801|Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).
11346285|NCT04392219|FG007|Participant Flow|Part 1 - 1200 mg EIDD-2801|Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).
11346286|NCT04392219|FG008|Participant Flow|Part 1 - 1600 mg EIDD-2801|Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).
11346287|NCT04392219|FG009|Participant Flow|Part 2 - 200 mg EIDD-2801 (Fasted/Fed)|Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed).
11346288|NCT04392219|FG010|Participant Flow|Part 3 - Placebo|Participants were randomized to receive a twice daily dosing of Placebo capsules (fasted).
11346289|NCT04392219|FG011|Participant Flow|Part 3 - 50 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 50-mg EIDD-2801 capsules (fasted).
11346290|NCT04392219|FG012|Participant Flow|Part 3 - 100 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 100-mg EIDD-2801 capsules (fasted).
11346291|NCT04392219|FG013|Participant Flow|Part 3 - 200 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 200-mg EIDD-2801 capsules (fasted).
11346292|NCT04392219|FG014|Participant Flow|Part 3 - 300 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 300-mg EIDD-2801 capsules (fasted).
11346293|NCT04392219|FG015|Participant Flow|Part 3 - 400 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 400-mg EIDD-2801 capsules (fasted).
11346294|NCT04392219|FG016|Participant Flow|Part 3 - 600 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 600-mg EIDD-2801 capsules (fasted).
11346295|NCT04392219|FG017|Participant Flow|Part 3 - 800 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 800-mg EIDD-2801 capsules (fasted).
11346296|NCT04392219|OG000|Outcome|Part 1 - Placebo|Participants were randomized to receive a single oral dose of Placebo (fasted).
11346297|NCT04392219|OG001|Outcome|Part 1 - 50 mg EIDD-2801|Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).
11346298|NCT04392219|OG002|Outcome|Part 1 - 100 mg EIDD-2801|Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).
11346299|NCT04392219|OG003|Outcome|Part 1 - 200 mg EIDD-2801|Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).
11346300|NCT04392219|OG004|Outcome|Part 1 - 400 mg EIDD-2801|Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).
11346301|NCT04392219|OG005|Outcome|Part 1 - 600 mg EIDD-2801|Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).
11346302|NCT04392219|OG006|Outcome|Part 1 - 800 mg EIDD-2801|Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).
11346303|NCT04392219|OG007|Outcome|Part 1 - 1200 mg EIDD-2801|Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).
11346304|NCT04392219|OG008|Outcome|Part 1 - 1600 mg EIDD-2801|Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).
11346305|NCT04392219|OG000|Outcome|Part 3 - Placebo|Participants were randomized to receive twice daily dosing of Placebo capsules (fasted).
11346306|NCT04392219|OG001|Outcome|Part 3 - 50 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 50 mg EIDD-2801 capsules (fasted).
11346307|NCT04392219|OG002|Outcome|Part 3 - 100 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 100 mg EIDD-2801 capsules (fasted).
11346308|NCT04392219|OG003|Outcome|Part 3 - 200 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 200 mg EIDD-2801 capsules (fasted).
11346309|NCT04392219|OG004|Outcome|Part 3 - 300 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 300 mg EIDD-2801 capsules (fasted).
11346310|NCT04392219|OG005|Outcome|Part 3 - 400 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 400 mg EIDD-2801 capsules (fasted).
11346311|NCT04392219|OG006|Outcome|Part 3 - 600 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 600 mg EIDD-2801 capsules (fasted).
11346312|NCT04392219|OG007|Outcome|Part 3 - 800 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 800 mg EIDD-2801 capsules (fasted).
11346313|NCT04392219|EG000|Reported Event|Part 1 - Placebo|Participants were randomized to receive a single oral dose of Placebo (fasted).
11346314|NCT04392219|EG001|Reported Event|Part 1 - 50 mg EIDD-2801|Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).
11346315|NCT04392219|EG002|Reported Event|Part 1 - 100 mg EIDD-2801|Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).
11346316|NCT04392219|EG003|Reported Event|Part 1 - 200 mg EIDD-2801|Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).
11346317|NCT04392219|EG004|Reported Event|Part 1 - 400 mg EIDD-2801|Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).
11346318|NCT04392219|EG005|Reported Event|Part 1 - 600 mg EIDD-2801|Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).
11346319|NCT04392219|EG006|Reported Event|Part 1 - 800 mg EIDD-2801|Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).
11346320|NCT04392219|EG007|Reported Event|Part 1 - 1200 mg EIDD-2801|Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).
11346321|NCT04392219|EG008|Reported Event|Part 1 - 1600 mg EIDD-2801|Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).
11346322|NCT04392219|EG009|Reported Event|Part 2 - 200 mg EIDD-2801 (Fasted)|Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted).
11346323|NCT04392219|EG010|Reported Event|Part 2 - 200 mg EIDD-2801 (Fed)|Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fed).
11346324|NCT04392219|EG011|Reported Event|Part 3 - Placebo|Participants were randomized to receive twice daily dosing of Placebo capsules (fasted).
11346325|NCT04392219|EG012|Reported Event|Part 3 - 50 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 50-mg EIDD-2801 capsules (fasted).
11346326|NCT04392219|EG013|Reported Event|Part 3 - 100 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 100-mg EIDD-2801 capsules (fasted).
11346327|NCT04392219|EG014|Reported Event|Part 3 - 200 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 200-mg EIDD-2801 capsules (fasted).
11346328|NCT04392219|EG015|Reported Event|Part 3 - 300 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 300-mg EIDD-2801 capsules (fasted).
11346329|NCT04392219|EG016|Reported Event|Part 3 - 400 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 400-mg EIDD-2801 capsules (fasted).
11346330|NCT04392219|EG017|Reported Event|Part 3 - 600 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 600-mg EIDD-2801 capsules (fasted).
11346331|NCT04392219|EG018|Reported Event|Part 3 - 800 mg EIDD-2801|Participants were randomized to receive twice daily dosing of 800-mg EIDD-2801 capsules (fasted).
11346332|NCT04391842|BG000|Baseline|Experimental: SAM Ultrasound and Diclofenac Patch|"Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sustained Acoustic Device with 1% Diclofenac patch: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch~Other Names:~ZetrOZ ultrasound device~wearable ultrasound device~long duration ultrasound~LITUS device~long duration low intensity device"
11346333|NCT04391842|FG000|Participant Flow|Experimental: SAM Ultrasound and Diclofenac Patch|"Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sustained Acoustic Device with 1% Diclofenac patch: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch~Other Names:~ZetrOZ ultrasound device~wearable ultrasound device~long duration ultrasound~LITUS device~long duration low intensity device"
11346334|NCT04391842|OG000|Outcome|Experimental: SAM Ultrasound and Diclofenac Patch|"Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sustained Acoustic Device with 1% Diclofenac patch: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch~Other Names:~ZetrOZ ultrasound device~wearable ultrasound device~long duration ultrasound~LITUS device~long duration low intensity device"
11346335|NCT04391842|EG000|Reported Event|Experimental: SAM Ultrasound and Diclofenac Patch|"Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sustained Acoustic Device with 1% Diclofenac patch: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch~Other Names:~ZetrOZ ultrasound device~wearable ultrasound device~long duration ultrasound~LITUS device~long duration low intensity device"
11346336|NCT04390022|BG000|Baseline|Ivermectin|"Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.~(Single dose of STROMECTOL® tablets at 400mcg/kg)"
11346337|NCT04390022|BG001|Baseline|Placebo|"Participants on this arm received a single, oral dose of placebo tablets at the enrollment visit.~(Placebo tablets did not match ivermectin but they were administered by staff not involved in the clinical care)"
11346338|NCT04390022|BG002|Baseline|Total|Total of all reporting groups
11346339|NCT04390022|FG000|Participant Flow|Ivermectin|"Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.~(Single dose of STROMECTOL® tablets at 400mcg/kg)"
11346340|NCT04390022|FG001|Participant Flow|Placebo|"Participants on this arm received a single, oral dose of placebo tablets at the enrollment visit.~(Placebo tablets did not match ivermectin but they were administered by staff not involved in the clinical care)"
11346341|NCT04390022|OG000|Outcome|Ivermectin|"Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.~(Single dose of STROMECTOL® tablets at 400mcg/kg)"
11346342|NCT04390022|OG001|Outcome|Placebo|"Participants on this arm received a single, oral dose of placebo tablets at the enrollment visit.~(Placebo tablets did not match ivermectin but they were administered by staff not involved in the clinical care)"
11346343|NCT04390022|EG000|Reported Event|Ivermectin|"Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.~(Single dose of STROMECTOL® tablets at 400mcg/kg)"
11346344|NCT04390022|EG001|Reported Event|Placebo|"Participants on this arm received a single, oral dose of placebo tablets at the enrollment visit.~(Placebo tablets did not match ivermectin but they were administered by staff not involved in the clinical care)"
11348574|NCT04161807|BG000|Baseline|Nerivio Device Treatment|"participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started~Nerivio: The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
11346345|NCT04386902|BG000|Baseline|Patients|"Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE)~Neurosteer Aurora system: The system is composed of hardware and software modules that facilitate the capture and interpretation of electrophysiological data as well as enable viewing the processed data in real time and offline. An electrode patch is attached on the subject's forehead to capture the electrophysiological signal. The signal is sent via low energy Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to the cloud where the data is stored on a HIPAA compliant server. Data analysis performed in the cloud transforms the electrophysiological signal into easily readable data of brain activity, which is accessible via any web interface."
11346346|NCT04386902|FG000|Participant Flow|Patients|"Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE)~Neurosteer Aurora system: The system is composed of hardware and software modules that facilitate the capture and interpretation of electrophysiological data as well as enable viewing the processed data in real time and offline. An electrode patch is attached on the subject's forehead to capture the electrophysiological signal. The signal is sent via low energy Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to the cloud where the data is stored on a HIPAA compliant server. Data analysis performed in the cloud transforms the electrophysiological signal into easily readable data of brain activity, which is accessible via any web interface."
11346347|NCT04386902|OG000|Outcome|Patients|"Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE).~Neurosteer Aurora system: The system is composed of hardware and software modules that facilitate the capture and interpretation of electrophysiological data as well as enable viewing the processed data in real time and offline. An electrode patch is attached on the subject's forehead to capture the electrophysiological signal. The signal is sent via low energy Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to the cloud where the data is stored on a HIPAA compliant server. Data analysis performed in the cloud transforms the electrophysiological signal into easily readable data of brain activity, which is accessible via any web interface."
11346348|NCT04386902|EG000|Reported Event|Patients|"Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE)~Neurosteer Aurora system: The system is composed of hardware and software modules that facilitate the capture and interpretation of electrophysiological data as well as enable viewing the processed data in real time and offline. An electrode patch is attached on the subject's forehead to capture the electrophysiological signal. The signal is sent via low energy Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to the cloud where the data is stored on a HIPAA compliant server. Data analysis performed in the cloud transforms the electrophysiological signal into easily readable data of brain activity, which is accessible via any web interface."
11346349|NCT04385238|BG000|Baseline|Pregnant Women|"Pregnant women who are 18 years of age or older.~This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention."
11346350|NCT04385238|BG001|Baseline|Post-partum Women|"Women who gave birth within the last 6 months who are 18 years of age or older.~This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention."
11346351|NCT04385238|BG002|Baseline|Total|Total of all reporting groups
11346352|NCT04385238|FG000|Participant Flow|Pregnant Women|"Pregnant women who are 18 years of age or older.~This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention."
11346353|NCT04385238|FG001|Participant Flow|Post-partum Women|"Women who gave birth within the last 6 months who are 18 years of age or older.~This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention."
11346354|NCT04385238|OG000|Outcome|Pregnant Women|"Pregnant women who are 18 years of age or older.~This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention."
11346355|NCT04385238|OG001|Outcome|Post-partum Women|"Women who gave birth within the last 6 months who are 18 years of age or older.~This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention."
10855524|NCT00329719|FG003|Participant Flow|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
11346356|NCT04385238|EG000|Reported Event|Pregnant Women|"Pregnant women who are 18 years of age or older.~This is an online survey with no intervention: As this is an online survey about health and wellbeing, there is no intervention and no assessment of adverse events."
11346357|NCT04385238|EG001|Reported Event|Post-partum Women|"Women who gave birth within the last 6 months who are 18 years of age or older.~This is an online survey with no intervention: As this is an online survey about health and wellbeing, there is no intervention and no assessment of adverse events."
11346358|NCT04384523|BG000|Baseline|Placebo|Placebo: Normal Saline (0.9% Sodium Chloride)
11346359|NCT04384523|BG001|Baseline|OsrHSA 20 mg/kg IV|OsrHSA 20 mg/kg IV: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
11346360|NCT04384523|BG002|Baseline|OsrHSA 40 mg/kg IV|OsrHSA 40 mg/kg IV: A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
11346361|NCT04384523|BG003|Baseline|OsrHSA 80 mg/kg IV|OsrHSA 80 mg/kg IV: A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
11346362|NCT04384523|BG004|Baseline|OsrHSA 140 mg/kg IV|OsrHSA 140 mg/kg IV: A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
11346363|NCT04384523|BG005|Baseline|OsrHSA 200 mg/kg IV|OsrHSA 200 mg/kg IV: A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
11346364|NCT04384523|BG006|Baseline|Total|Total of all reporting groups
11346365|NCT04384523|FG000|Participant Flow|Placebo|Placebo: Normal Saline (0.9% Sodium Chloride)
11346366|NCT04384523|FG001|Participant Flow|OsrHSA 20 mg/kg IV|OsrHSA 20 mg/kg IV: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
11346367|NCT04384523|FG002|Participant Flow|OsrHSA 40 mg/kg IV|OsrHSA 40 mg/kg IV: A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
11346368|NCT04384523|FG003|Participant Flow|OsrHSA 80 mg/kg IV|OsrHSA 80 mg/kg IV: A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
11346369|NCT04384523|FG004|Participant Flow|OsrHSA 140 mg/kg IV|OsrHSA 140 mg/kg IV: A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
11346370|NCT04384523|FG005|Participant Flow|OsrHSA 200 mg/kg IV|OsrHSA 200 mg/kg IV: A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
11346371|NCT04384523|OG000|Outcome|Placebo|Normal Saline (0.9% Sodium Chloride)
11346372|NCT04384523|OG001|Outcome|OsrHSA 20 mg/kg IV|A single dose of OsrHSA 20 mg/kg IV
11346373|NCT04384523|OG002|Outcome|OsrHSA 40 mg/kg IV|A single dose of OsrHSA 40 mg/kg IV
11346374|NCT04384523|OG003|Outcome|OsrHSA 80 mg/kg IV|A single dose of OsrHSA 80 mg/kg IV
11346375|NCT04384523|OG004|Outcome|OsrHSA 140 mg/kg IV|A single dose of OsrHSA 140 mg/kg IV
11346376|NCT04384523|OG005|Outcome|OsrHSA 200 mg/kg IV|A single dose of OsrHSA 200 mg/kg IV
11346377|NCT04384523|OG000|Outcome|Placebo|Placebo: Normal Saline (0.9% Sodium Chloride)
11346378|NCT04384523|OG001|Outcome|OsrHSA 20 mg/kg IV|OsrHSA 20 mg/kg IV: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
11346379|NCT04384523|OG002|Outcome|OsrHSA 40 mg/kg IV|OsrHSA 40 mg/kg IV: A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
11346380|NCT04384523|OG003|Outcome|OsrHSA 80 mg/kg IV|OsrHSA 80 mg/kg IV: A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
11346381|NCT04384523|OG004|Outcome|OsrHSA 140 mg/kg IV|OsrHSA 140 mg/kg IV: A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
11346382|NCT04384523|OG005|Outcome|OsrHSA 200 mg/kg IV|OsrHSA 200 mg/kg IV: A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
11346383|NCT04384523|EG000|Reported Event|Placebo|Placebo: Normal Saline (0.9% Sodium Chloride)
11346384|NCT04384523|EG001|Reported Event|OsrHSA 20 mg/kg IV|OsrHSA 20 mg/kg IV: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
11346385|NCT04384523|EG002|Reported Event|OsrHSA 40 mg/kg IV|OsrHSA 40 mg/kg IV: A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
11346386|NCT04384523|EG003|Reported Event|OsrHSA 80 mg/kg IV|OsrHSA 80 mg/kg IV: A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
11346387|NCT04384523|EG004|Reported Event|OsrHSA 140 mg/kg IV|OsrHSA 140 mg/kg IV: A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
11346388|NCT04384523|EG005|Reported Event|OsrHSA 200 mg/kg IV|OsrHSA 200 mg/kg IV: A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
11346389|NCT04383665|BG000|Baseline|All Study Participants|All Study Participants
11346390|NCT04383665|FG000|Participant Flow|Off/10 Hz/130 Hz|"STN DBS device turned off~STN DBS at 10 Hz~STN DBS at 130 Hz"
11346391|NCT04383665|FG001|Participant Flow|Off/130 Hz/10 Hz|"STN DBS device turned off~STN DBS at 130 Hz~STN DBS at 10 Hz"
11346392|NCT04383665|FG002|Participant Flow|10 Hz/Off/130 Hz|"STN DBS at 10 Hz~STN DBS device turned off~STN DBS at 130 Hz"
11346393|NCT04383665|FG003|Participant Flow|10 Hz/130 Hz/Off|"STN DBS at 10 Hz~STN DBS at 130 Hz~STN DBS device turned off"
11346394|NCT04383665|FG004|Participant Flow|130 Hz/Off/10 Hz|"STN DBS at 130 Hz~STN DBS device turned off~STN DBS at 10 Hz"
11346395|NCT04383665|FG005|Participant Flow|130 Hz/10 Hz/Off|"STN DBS at 130 Hz~STN DBS at 10 Hz~STN DBS device turned off"
11346396|NCT04383665|OG000|Outcome|STN DBS Off|STN DBS off: Existing DBS device turned off
11346397|NCT04383665|OG001|Outcome|STN DBS 10Hz|STN DBS 10Hz: Stimulation of existing DBS device at 100Hz, with other parameters at baseline
11346398|NCT04383665|OG002|Outcome|STN DBS 130Hz|STN DBS 130Hz: Stimulation of existing DBS device at 130Hz, with other parameters at baseline
11346399|NCT04383665|EG000|Reported Event|STN DBS Off|STN DBS off: Existing DBS device turned off
11346400|NCT04383665|EG001|Reported Event|STN DBS 10Hz|STN DBS 10Hz: Stimulation of existing DBS device at 100Hz, with other parameters at baseline
11346401|NCT04383665|EG002|Reported Event|STN DBS 130Hz|STN DBS 130Hz: Stimulation of existing DBS device at 130Hz, with other parameters at baseline
11346402|NCT04383132|BG000|Baseline|Abdominal Binder Intervention Group|"Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.~Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device"
11346403|NCT04383132|BG001|Baseline|Sham Group|"Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure~Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device"
11346404|NCT04383132|BG002|Baseline|Total|Total of all reporting groups
11346405|NCT04383132|FG000|Participant Flow|Abdominal Binder Intervention Group|"Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.~Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device"
11346406|NCT04383132|FG001|Participant Flow|Sham Group|"Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure~Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device"
11346407|NCT04383132|OG000|Outcome|Abdominal Binder Intervention Group|"Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.~Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device"
11346408|NCT04383132|OG001|Outcome|Sham Group|"Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure~Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device"
11346409|NCT04383132|EG000|Reported Event|Abdominal Binder Intervention Group|"Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.~Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device"
11346410|NCT04383132|EG001|Reported Event|Sham Group|"Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure~Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device"
11346411|NCT04382066|BG000|Baseline|Experimental 1|"Plitidepsin 1.5 mg / day x 3 consecutive days~Plitidepsin 1.5 mg/day: Plitidepsin 1.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days."
11346412|NCT04382066|BG001|Baseline|Experimental 2|"Plitidepsin 2.0 mg / day x 3 consecutive days~Plitidepsin 2.0 mg/day: Plitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days."
11346413|NCT04382066|BG002|Baseline|Experimental 3|"Plitidepsin 2.5 mg / day x 3 consecutive days~Plitidepsin 2.5 mg/day: Plitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days."
11346414|NCT04382066|BG003|Baseline|Total|Total of all reporting groups
11346415|NCT04382066|FG000|Participant Flow|Experimental 1|"Plitidepsin 1.5 mg / day x 3 consecutive days~Plitidepsin 1.5 mg/day: Plitidepsin 1.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days."
11346416|NCT04382066|FG001|Participant Flow|Experimental 2|"Plitidepsin 2.0 mg / day x 3 consecutive days~Plitidepsin 2.0 mg/day: Plitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days."
11346417|NCT04382066|FG002|Participant Flow|Experimental 3|"Plitidepsin 2.5 mg / day x 3 consecutive days~Plitidepsin 2.5 mg/day: Plitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days."
11346418|NCT04382066|OG000|Outcome|Experimental 1|Plitidepsin 1.5 mg / day x 3 consecutive days
11346419|NCT04382066|OG001|Outcome|Experimental 2|Plitidepsin 2.0 mg / day x 3 consecutive days
11346420|NCT04382066|OG002|Outcome|Experimental 3|Plitidepsin 2.5 mg / day x 3 consecutive days
11346421|NCT04382066|OG003|Outcome|Total|All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
11346422|NCT04382066|EG000|Reported Event|Experimental 1|Plitidepsin 1.5 mg / day x 3 consecutive days
11346423|NCT04382066|EG001|Reported Event|Experimental 2|Plitidepsin 2.0 mg / day x 3 consecutive days
11346424|NCT04382066|EG002|Reported Event|Experimental 3|Plitidepsin 2.5 mg / day x 3 consecutive days
11346425|NCT04382066|EG003|Reported Event|Total|All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
11346426|NCT04381481|BG000|Baseline|Control Beverage, Text Snack|"The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2)."
11346427|NCT04381481|BG001|Baseline|Control Beverage, Control Snack|The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a barcode label (control label) (task 2).
11346428|NCT04381481|BG002|Baseline|Control Beverage, Graphic Snack|"The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2)."
11346429|NCT04381481|BG003|Baseline|Claim 1 Beverage, Text Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2)."
11346430|NCT04381481|BG004|Baseline|Claim 1 Beverage, Control Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a barcode label (control label) (task 2)."
11346431|NCT04381481|BG005|Baseline|Claim 1 Beverage, Graphic Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2)."
11346432|NCT04381481|BG006|Baseline|Claim 2 Beverage, Text Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2)."
11346433|NCT04381481|BG007|Baseline|Claim 2 Beverage, Control Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a barcode label (control label) (task 2)."
11346434|NCT04381481|BG008|Baseline|Claim 2 Beverage, Graphic Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2)."
11346435|NCT04381481|BG009|Baseline|Claim 3 Beverage, Text Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2)."
11346436|NCT04381481|BG010|Baseline|Claim 3 Beverage, Control Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a barcode label (control label) (task 2)."
11346437|NCT04381481|BG011|Baseline|Claim 3 Beverage, Graphic Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2)."
11346438|NCT04381481|BG012|Baseline|Total|Total of all reporting groups
11346439|NCT04381481|FG000|Participant Flow|Control Beverage, Text Snack|"The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2).~Control Drink: No nutrition claim: Fruit drinks does not contain a nutrition claim (task 1)~Experimental snack: Text warning: The snack contains a text warning (task 2)"
11346440|NCT04381481|FG001|Participant Flow|Control Beverage, Control Snack|"The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a barcode label (control label) (task 2).~Control Drink: No nutrition claim: Fruit drinks does not contain a nutrition claim (task 1)~Control snack: barcode label: The snack contains a neutral barcode label (task 2)"
11346441|NCT04381481|FG002|Participant Flow|Control Beverage, Graphic Snack|"The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Control Drink: No nutrition claim: Fruit drinks does not contain a nutrition claim (task 1)~Experimental snack: Graphic warning: The snack contains a graphic warning (task 2)"
10976669|NCT00941720|FG000|Participant Flow|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
11346442|NCT04381481|FG003|Participant Flow|Claim 1 Beverage, Text Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Text warning: The snack contains a text warning (task 2)"
11346443|NCT04381481|FG004|Participant Flow|Claim 1 Beverage, Control Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a barcode label (control label) (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Control snack: barcode label: The snack contains a neutral barcode label (task 2)"
11346444|NCT04381481|FG005|Participant Flow|Claim 1 Beverage, Graphic Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Graphic warning: The snack contains a graphic warning (task 2)"
11346445|NCT04381481|FG006|Participant Flow|Claim 2 Beverage, Text Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Text warning: The snack contains a text warning (task 2)"
11346446|NCT04381481|FG007|Participant Flow|Claim 2 Beverage, Control Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a barcode label (control label) (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Control snack: barcode label: The snack contains a neutral barcode label (task 2)"
11346447|NCT04381481|FG008|Participant Flow|Claim 2 Beverage, Graphic Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Graphic warning: The snack contains a graphic warning (task 2)"
11346448|NCT04381481|FG009|Participant Flow|Claim 3 Beverage, Text Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Text warning: The snack contains a text warning (task 2)"
11346449|NCT04381481|FG010|Participant Flow|Claim 3 Beverage, Control Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a barcode label (control label) (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Control snack: barcode label: The snack contains a neutral barcode label (task 2)"
11346450|NCT04381481|FG011|Participant Flow|Claim 3 Beverage, Graphic Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Graphic warning: The snack contains a graphic warning (task 2)"
11346451|NCT04381481|OG000|Outcome|Control Beverage|"The participant will see fruit drinks with no nutrition claims (task 1).~Control Drink: No nutrition claim: Fruit drinks does not contain a nutrition claim (task 1)"
11346452|NCT04381481|OG001|Outcome|Claim 1 Beverage|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)"
11346453|NCT04381481|OG002|Outcome|Claim 2 Beverage|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)"
11346454|NCT04381481|OG003|Outcome|Claim 3 Beverage|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)"
11346455|NCT04381481|OG000|Outcome|Control Snack|"The participant will see a snack with a barcode label (control label)~Control snack: barcode label: The snack contains a neutral barcode label"
11346456|NCT04381481|OG001|Outcome|Text Snack|"The participant will see a snack with a text warning WARNING: High in added sugar~Experimental snack: Text warning: The snack contains a text warning"
11346457|NCT04381481|OG002|Outcome|Graphic Snack|"The participant will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Experimental snack: Graphic warning: The snack contains a graphic warning"
11346458|NCT04381481|OG000|Outcome|Control Beverage|The participant will see fruit drinks with no nutrition claims (task 1). Control Drink: No nutrition claim: Fruit drinks does not contain a nutrition claim (task 1)
11346459|NCT04381481|OG003|Outcome|Claim 3 Beverage|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1).~Experimental Drink: Nutrition claim on fruit drinks: Frui"
11346460|NCT04381481|OG000|Outcome|Control Snack|The participant will see a snack with a barcode label (control label) Control snack: barcode label: The snack contains a neutral barcode label
11346461|NCT04381481|OG001|Outcome|Text Snack|"The participant will see a snack with a text warning WARNING: High in added sugar Experimental snack: Text warning: The snack contains a text warning"
11346462|NCT04381481|OG002|Outcome|Graphic Snack|"The participant will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar Experimental snack: Graphic warning: The snack contains a graphic warning"
11346463|NCT04381481|EG000|Reported Event|Control Beverage, Text Snack|"The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2).~Control Drink: No nutrition claim: Fruit drinks does not contain a nutrition claim (task 1)~Experimental snack: Text warning: The snack contains a text warning (task 2)"
11346464|NCT04381481|EG001|Reported Event|Control Beverage, Control Snack|"The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a barcode label (control label) (task 2).~Control Drink: No nutrition claim: Fruit drinks does not contain a nutrition claim (task 1)~Control snack: barcode label: The snack contains a neutral barcode label (task 2)"
11346465|NCT04381481|EG002|Reported Event|Control Beverage, Graphic Snack|"The participant will see fruit drinks with no nutrition claims (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Control Drink: No nutrition claim: Fruit drinks does not contain a nutrition claim (task 1)~Experimental snack: Graphic warning: The snack contains a graphic warning (task 2)"
11346466|NCT04381481|EG003|Reported Event|Claim 1 Beverage, Text Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Text warning: The snack contains a text warning (task 2)"
11346467|NCT04381481|EG004|Reported Event|Claim 1 Beverage, Control Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a barcode label (control label) (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Control snack: barcode label: The snack contains a neutral barcode label (task 2)"
11346468|NCT04381481|EG005|Reported Event|Claim 1 Beverage, Graphic Snack|"The participant will see fruit drinks with the nutrition claim No Artificial Sweeteners (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Graphic warning: The snack contains a graphic warning (task 2)"
11346469|NCT04381481|EG006|Reported Event|Claim 2 Beverage, Text Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Text warning: The snack contains a text warning (task 2)"
11346470|NCT04381481|EG007|Reported Event|Claim 2 Beverage, Control Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a barcode label (control label) (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Control snack: barcode label: The snack contains a neutral barcode label (task 2)"
11346471|NCT04381481|EG008|Reported Event|Claim 2 Beverage, Graphic Snack|"The participants will see fruit drinks with the nutrition claim 100% Vitamin C daily value (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Graphic warning: The snack contains a graphic warning (task 2)"
11346472|NCT04381481|EG009|Reported Event|Claim 3 Beverage, Text Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a text warning WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Text warning: The snack contains a text warning (task 2)"
11346473|NCT04381481|EG010|Reported Event|Claim 3 Beverage, Control Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a barcode label (control label) (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Control snack: barcode label: The snack contains a neutral barcode label (task 2)"
11346474|NCT04381481|EG011|Reported Event|Claim 3 Beverage, Graphic Snack|"The participants will see fruit drinks with the nutrition claim 100% All Natural (task 1). They will see a snack with a graphic label (image of sugar cubes in a cup) along with the text WARNING: High in added sugar (task 2).~Experimental Drink: Nutrition claim on fruit drinks: Fruit drink contains a nutrition claim (task 1)~Experimental snack: Graphic warning: The snack contains a graphic warning (task 2)"
11346475|NCT04380688|BG000|Baseline|Acalabrutinib + BSC|Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines.
11346476|NCT04380688|BG001|Baseline|BSC Alone|Participants received best supportive care per the discretion of the Investigator and institutional guidelines.
11346477|NCT04380688|BG002|Baseline|Total|Total of all reporting groups
11346478|NCT04380688|FG000|Participant Flow|Acalabrutinib + BSC|Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines.
10976670|NCT00941720|OG000|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
10976671|NCT00941720|EG000|Reported Event|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
11346479|NCT04380688|FG001|Participant Flow|BSC Alone|Participants received best supportive care per the discretion of the Investigator and institutional guidelines.
11346480|NCT04380688|OG000|Outcome|Acalabrutinib + BSC|Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines.
11346481|NCT04380688|OG001|Outcome|BSC Alone|Participants received best supportive care per the discretion of the Investigator and institutional guidelines.
10976672|NCT00941733|BG000|Baseline|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
10855525|NCT00329719|OG000|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855526|NCT00329719|OG001|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855527|NCT00329719|OG002|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
11346482|NCT04380688|EG000|Reported Event|Acalabrutinib + BSC|Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines.
11346483|NCT04380688|EG001|Reported Event|BSC Alone|Participants received best supportive care per the discretion of the Investigator and institutional guidelines.
11346484|NCT04376060|BG000|Baseline|Study Population|Patients who received the intervention of horizontal bone augmentation using the cortical lamina and the equine-derived bone particles,
11346485|NCT04376060|FG000|Participant Flow|Study Population|Patients who complied with the inclusion criteria of this study and received the procedure of horizontal bone augmentation.
11346486|NCT04376060|OG000|Outcome|Study Population|Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
11346487|NCT04376060|EG000|Reported Event|Study Population|Patients who complied with the inclusion criteria of this study and received the procedure of horizontal bone augmentation.
10855528|NCT00329719|OG003|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855529|NCT00329719|EG000|Reported Event|Phase I, Arm A|"Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855530|NCT00329719|EG001|Reported Event|Phase II, Arm B|"Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10855531|NCT00329719|EG002|Reported Event|Phase II, Arm C|"Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
10855532|NCT00329719|EG003|Reported Event|Phase II, Arm D|"Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
10976673|NCT00941733|BG001|Baseline|Standard PTA|Standard PTA balloon: Balloon Angioplasty
11346488|NCT04374500|BG000|Baseline|Healthy Males (n=17) and CAD Patients (n=83)|"Table 1. Baseline characteristics 17 healthy males~Age (years) Weight (kg) Height (cm) BMI (kg/m2) Waist circumference (cm) Hip circumference (cm) Waist-to-Hip (ratio) Heart rate (beats/min) Systolic blood pressure (SBT) (mmHg) Diastolic blood pressure (DBT) (mmHg)~Table 2. Baseline characteristics 83 men and women with CAD~Age (years) Sex (male/female) BMI (kg/m2) Heart rate (beats/min) SBT (mmHg) DBT (mmHg) Cigarette smoking (n) Co-morbidity (n) Previous myocardial infarction Hypertension Family history of coronary heart disease Hypercholesterolaemia Medication (n) Aspirin Lipid lowering therapy Angiotensin converting enzyme inhibitor (ACEi) Angiotensin receptor blocker (ARB)Creatinine (µmol/L) Glucose (mmol/L) Total cholesterol (mmol/L) ProBNP (pg/nL) C-reactive protein (mg/L)"
11346489|NCT04374500|FG000|Participant Flow|Leptin Infusion in Healthy Men|This applies to protocol 1 when 10 healthy men got infusion of leptin locally and forearm blood flow was measured with the other arm as the control.
11346490|NCT04374500|FG001|Participant Flow|Leptin or Saline Infusion Plus Vasodilators in Healthy Men|This applies to protocol 2 when 10 healthy men got either a background infusion of leptin or saline when measuring vasoresponse to four vasodilatators. Each participant had two examinations with either leptin or saline and the order was randomised.
11346491|NCT04374500|FG002|Participant Flow|Vasodilators in CAD Patients|This applies to protocol 3 when blood flow was measured in the forearm after infusion of 3 vasodilators, and the response was related to endogenous leptin levels
11346492|NCT04374500|OG000|Outcome|Leptin Infusion|In protocol 1, blood flow in the infused forearm did not change with leptin infusion
11346493|NCT04374500|OG001|Outcome|Leptin Plus Vasodilators|In protocol 2, blood flow in the infused forearm did not change with leptin infusion whereas blod flow changed as expected with vasodilators, but blunted with concomitant leptin infusion versus saline infusion
11346494|NCT04374500|OG002|Outcome|Vasodilators in CAD Patients|Blood flow was measured locally in the forearm after infusion of vasodilators. No leptin was given.
11346495|NCT04374500|OG000|Outcome|Leptin Infusion in Healthy Men|This applies to protocol 1 when 10 healthy men got infusion of leptin locally and forearm blood flow was measured with the other arm as the control.
11346496|NCT04374500|OG001|Outcome|Leptin or Saline Infusion Plus Vasodilators in Healthy Men|This applies to protocol 2 when 10 healthy men got either a background infusion of leptin or saline when measuring vasoresponse to four vasodilatators. Each participant had two examinations with either leptin or saline and the order was randomised.
11346497|NCT04374500|OG002|Outcome|Vasodilators in CAD Patients|This applies to protocol 3 when blood flow was measured in the forearm after infusion of 3 vasodilators, and the response was related to endogenous leptin levels
11346498|NCT04374500|EG000|Reported Event|Leptin Infusion|"In protocol 1, each participant got leptin locally in the studied forearm whereas the other forearm acted as control.~No adverse effects were reported."
11346499|NCT04374500|EG001|Reported Event|Leptin Infusion Plus Vasodilator Infusion|"In protocol 2, each participant got ether saline or leptin locally in the studied forearm whereas the other arm acted as control. Local vasodilators were given in the studied forearm on top of leptin/saline infusion. The experiment was repeated and each participant participated twice.~No adverse effects were reported."
11346500|NCT04374500|EG002|Reported Event|Vasodilator Infusion in CAD Patients|"In protocol 3, only vasodilators were given in the studied forearm, and no leptin was given.~No adverse effects were reported."
11346501|NCT04372186|BG000|Baseline|Tocilizumab|Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
11346502|NCT04372186|BG001|Baseline|Placebo|Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
11346503|NCT04372186|BG002|Baseline|Total|Total of all reporting groups
11346504|NCT04372186|FG000|Participant Flow|Tocilizumab|Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
11346505|NCT04372186|FG001|Participant Flow|Placebo|Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
11346506|NCT04372186|OG000|Outcome|Tocilizumab|Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
11346507|NCT04372186|OG001|Outcome|Placebo|Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
11346508|NCT04372186|EG000|Reported Event|Tocilizumab|Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
11346509|NCT04372186|EG001|Reported Event|Placebo|Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
11346510|NCT04371419|BG000|Baseline|Study Participants - Control|Study participants who are assigned to a pure control group
11346511|NCT04371419|BG001|Baseline|Study Participants - Any Intervention|Study participants who are assigned to any intervention groups
11346512|NCT04371419|BG002|Baseline|Total|Total of all reporting groups
11346513|NCT04371419|FG000|Participant Flow|Control - CDC - Mask (Control) - Concordant|"Control Intro, CDC Social Distancing, Mask Control version delivered by minority doctor of same background as the recipient - other definitions are similar~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346514|NCT04371419|FG001|Participant Flow|Control - CDC - Mask (Control) - Discordant|"Control Intro, CDC Social Distancing, Mask Control version delivered by majority doctor of different background as the recipient - other definitions are similar~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346515|NCT04371419|FG002|Participant Flow|Control - MGH - Mask (Control) - Concordant|"Control Intro, MGH Social Distancing, Mask Control version delivered by concordant doctor~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346516|NCT04371419|FG003|Participant Flow|Control - MGH - Mask (Control) - Discordant|"Control Intro, MGH Social Distancing, Mask Control version delivered by discordant doctor~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346517|NCT04371419|FG004|Participant Flow|Ack. Discrimination- MGH - Mask (Control) - Concordant|"Introduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by concordant MD~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346518|NCT04371419|FG005|Participant Flow|Ack. Discrimination- MGH - Mask (Control) - Discordant|"Introduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by discordant MD~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346519|NCT04371419|FG006|Participant Flow|Ack. Econ. Circumstance- MGH - Mask (Control ) Concordant|"Intro econ. circumstance -MGH - Mask (Control ) Concordant~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346520|NCT04371419|FG007|Participant Flow|Ack. Econ. Circumstance - MGH - Mask (Control ) Discordant|"Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346521|NCT04371419|FG008|Participant Flow|Control Intro - CDC - Mask (antiStigma) Concordant|"Control Intro - CDC - Mask (antiStigma) Concordant messenger~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346522|NCT04371419|FG009|Participant Flow|Control Intro - CDC - Mask (antiStigma) Discordant|"Control Intro - CDC - Mask (antiStigma) discordant messenger~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346523|NCT04371419|FG010|Participant Flow|Control - MGH - MaskS (antiStigma) Concordant Messenger|"Control - MGH - MaskS (antiStigma) Concordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
10976674|NCT00941733|BG002|Baseline|Total|Total of all reporting groups
11346524|NCT04371419|FG011|Participant Flow|Control- MGH-MaskS (antiStigma) Discordant Messenger|"Control - MGH - MaskS (antiStigma) Discordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346525|NCT04371419|FG012|Participant Flow|Ack. Discrimination - MGH - MaskS (antiStigma) Concordant|"Acknowledge Discrimination - MGH - MaskS (antiStigma) Concordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346526|NCT04371419|FG013|Participant Flow|Ack. Discrimination - MGH - MaskS (antiStigma) Discordant|"Acknowledge Discrimination - MGH - MaskS (antiStigma) Discordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346527|NCT04371419|FG014|Participant Flow|Ack. Econ Hardship- MGH - Mask (antiStigma) Concordant|"Acknowledge Econ Hardship- MGH - Mask (antiStigma) Concordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346528|NCT04371419|FG015|Participant Flow|Ack. Econ Hardship- MGH - Mask (antiStigma) Discordant|"Acknowledge Econ Hardship- MGH - Mask (antiStigma) discordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346529|NCT04371419|FG016|Participant Flow|Info Later - Pure Control|"This group will not receive the videos but will receive information later.~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346530|NCT04371419|OG000|Outcome|Study Participants - Control|Study participants who are assigned to a pure control group
11346531|NCT04371419|OG001|Outcome|Study Participants - Any Intervention|Study participants who are assigned to any intervention groups
11346532|NCT04371419|OG000|Outcome|Intervention 1: Racial Discordance/Concordance Between Physician and Participant-Discordant (Arm A)|Study participants who were assigned to receive an intervention of racial discordance between physician and participant.
11346533|NCT04371419|OG001|Outcome|Intervention 1: Racial Discordance/Concordance Between Physician and Participant-Concordant (Arm B)|Study participants who were assigned to receive an intervention of racial concordance between physician and participant.
11346534|NCT04371419|OG002|Outcome|Intervention 2: Video 2 Recorded by MGH Physician/Dr. Birx of the CDC - MGH Physician (Arm A)|Participants who were assigned to receive the social distancing component of the message is recorded by the MGH physicians.
11346535|NCT04371419|OG003|Outcome|Intervention 2: Video 2 Recorded by MGH Physician/Dr. Birx of the CDC - Dr. Birx of the CDC (Arm B)|Participants who were assigned to receive the social distancing component of the message is delivered by Dr. Birx of the CDC.
10976675|NCT00941733|FG000|Participant Flow|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
11346536|NCT04371419|OG004|Outcome|Intervention 3: Received Acknowledgment of Discrimination - No (Arm A)|"Participants who were NOT assigned to receive the message include an acknowledgment of elephant in the room issues for each target group: trust in the medical system (African American participants) or fear of deportation (for Latinx participants)"
11346537|NCT04371419|OG005|Outcome|Intervention 3: Received Acknowledgment of Discrimination - Yes (Arm B)|"Participants who were assigned to receive the message include an acknowledgment of elephant in the room issues for each target group: trust in the medical system (African American participants) or fear of deportation (for Latinx participants)"
11346538|NCT04371419|OG006|Outcome|Intervention 4: Received Acknowledgment of Economic Inequalities - No (Arm A)|Participants who were NOT assigned to receive the message acknowledged economic hardships that were associated with tight living quarters and working in essential services.
11346539|NCT04371419|OG007|Outcome|Intervention 4: Received Acknowledgment of Economic Inequalities - Yes (Arm B)|Participants who were assigned to receive the message acknowledged economic hardships that were associated with tight living quarters and working in essential services.
11346540|NCT04371419|OG008|Outcome|Intervention 5: Received Information About Social Perception - No (Arm A)|Participants who were assigned to receive information about how representative individuals perceive mask wearers of color.
11346541|NCT04371419|OG009|Outcome|Intervention 5: Received Information About Social Perception - Yes (Arm B)|Participants who were assigned to receive information about how representative individuals perceive mask wearers of color.
11346542|NCT04371419|EG000|Reported Event|Control - CDC - Mask (Control) - Concordant|"Control Intro, CDC Social Distancing, Mask Control version delivered by minority doctor of same background as the recipient - other definitions are similar~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346543|NCT04371419|EG001|Reported Event|Control - CDC - Mask (Control) - Discordant|"Control Intro, CDC Social Distancing, Mask Control version delivered by majority doctor of different background as the recipient - other definitions are similar~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346544|NCT04371419|EG002|Reported Event|Control - MGH - Mask (Control) - Concordant|"Control Intro, MGH Social Distancing, Mask Control version delivered by concordant doctor~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346545|NCT04371419|EG003|Reported Event|Control - MGH - Mask (Control) - Discordant|"Control Intro, MGH Social Distancing, Mask Control version delivered by discordant doctor~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346546|NCT04371419|EG004|Reported Event|Ack. Discrimination- MGH - Mask (Control) - Concordant|"Introduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by concordant MD~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
10855533|NCT00329745|BG000|Baseline|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
11346547|NCT04371419|EG005|Reported Event|Ack. Discrimination- MGH - Mask (Control) - Discordant|"Introduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by discordant MD~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346548|NCT04371419|EG006|Reported Event|Ack. Econ. Circumstance- MGH - Mask (Control ) Concordant|"Intro econ. circumstance -MGH - Mask (Control ) Concordant~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346549|NCT04371419|EG007|Reported Event|Ack. Econ. Circumstance - MGH - Mask (Control ) Discordant|"Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346550|NCT04371419|EG008|Reported Event|Control Intro - CDC - Mask (antiStigma) Concordant|"Control Intro - CDC - Mask (antiStigma) Concordant messenger~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346551|NCT04371419|EG009|Reported Event|Control Intro - CDC - Mask (antiStigma) Discordant|"Control Intro - CDC - Mask (antiStigma) discordant messenger~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346552|NCT04371419|EG010|Reported Event|Control - MGH - MaskS (antiStigma) Concordant Messenger|"Control - MGH - MaskS (antiStigma) Concordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
10855534|NCT00329745|BG001|Baseline|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
10855535|NCT00329745|BG002|Baseline|Total|Total of all reporting groups
10855536|NCT00329745|FG000|Participant Flow|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
10855537|NCT00329745|FG001|Participant Flow|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
10855538|NCT00329745|OG000|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
10855539|NCT00329745|OG001|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
10855540|NCT00329745|EG000|Reported Event|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
10855541|NCT00329745|EG001|Reported Event|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
10855542|NCT00329771|BG000|Baseline|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
10976676|NCT00941733|FG001|Participant Flow|Standard PTA|Standard PTA balloon: Balloon Angioplasty
11346553|NCT04371419|EG011|Reported Event|Control- MGH-MaskS (antiStigma) Discordant Messenger|"Control - MGH - MaskS (antiStigma) Discordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346554|NCT04371419|EG012|Reported Event|Ack. Discrimination - MGH - MaskS (antiStigma) Concordant|"Acknowledge Discrimination - MGH - MaskS (antiStigma) Concordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346555|NCT04371419|EG013|Reported Event|Ack. Discrimination - MGH - MaskS (antiStigma) Discordant|"Acknowledge Discrimination - MGH - MaskS (antiStigma) Discordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346556|NCT04371419|EG014|Reported Event|Ack. Econ Hardship- MGH - Mask (antiStigma) Concordant|"Acknowledge Econ Hardship- MGH - Mask (antiStigma) Concordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346557|NCT04371419|EG015|Reported Event|Ack. Econ Hardship- MGH - Mask (antiStigma) Discordant|"Acknowledge Econ Hardship- MGH - Mask (antiStigma) discordant sender~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346558|NCT04371419|EG016|Reported Event|Info Later - Pure Control|"This group will not receive the videos but will receive information later.~Messaging: o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.~Some individuals in a control group will see messages later."
11346559|NCT04370834|BG000|Baseline|Other (Tocilizumab)|"Patients receive tocilizumab IV over 60 minutes. A second dose may be given if there is sustained or recurrent fever, no decrease or not more than a 1-category improvement on the 7-category ordinal scale (only stabilization or partial improvement following first dose), or a >= 1-category worsening on the 7-category ordinal scale from nadir.~Tocilizumab: Given IV"
10855543|NCT00329771|FG000|Participant Flow|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
10855544|NCT00329771|OG000|Outcome|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
10855545|NCT00329771|EG000|Reported Event|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
10855546|NCT00329784|BG000|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
11346560|NCT04370834|FG000|Participant Flow|Other (Tocilizumab)|"Patients receive tocilizumab IV over 60 minutes. A second dose may be given if there is sustained or recurrent fever, no decrease or not more than a 1-category improvement on the 7-category ordinal scale (only stabilization or partial improvement following first dose), or a >= 1-category worsening on the 7-category ordinal scale from nadir.~Tocilizumab: Given IV"
11346561|NCT04370834|OG000|Outcome|Cohort A1|Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, At least 30 kg
11346562|NCT04370834|OG001|Outcome|Cohort A2|Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, Less than 30 kg
11346563|NCT04370834|OG002|Outcome|Cohort B1|Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, At least 30 kg
11346564|NCT04370834|OG003|Outcome|Cohort B2|Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, Less than 30 kg
11346565|NCT04370834|EG000|Reported Event|Cohort A1|Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, At least 30 kg
11346566|NCT04370834|EG001|Reported Event|Cohort A2|Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, Less than 30 kg
11346567|NCT04370834|EG002|Reported Event|Cohort B1|Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, At least 30 kg
11346568|NCT04370834|EG003|Reported Event|Cohort B2|Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, Less than 30 kg
11346569|NCT04370548|BG000|Baseline|Clindamycin Phosphate Vaginal Gel, 2%|One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
11346570|NCT04370548|BG001|Baseline|Placebo Vaginal Gel (Universal HEC Placebo Gel)|One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
11346571|NCT04370548|BG002|Baseline|Total|Total of all reporting groups
11346572|NCT04370548|FG000|Participant Flow|Clindamycin Phosphate Vaginal Gel, 2%|One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
11346573|NCT04370548|FG001|Participant Flow|Placebo Vaginal Gel (Universal HEC Placebo Gel)|One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
11346574|NCT04370548|OG000|Outcome|Clindamycin Phosphate Vaginal Gel, 2%|One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
11346575|NCT04370548|OG001|Outcome|Placebo Vaginal Gel (Universal HEC Placebo Gel)|One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
11346576|NCT04370548|EG000|Reported Event|Clindamycin Phosphate Vaginal Gel, 2%|One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
11346577|NCT04370548|EG001|Reported Event|Placebo Vaginal Gel (Universal HEC Placebo Gel)|One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
11346578|NCT04370028|BG000|Baseline|Divaza Treatment Group|All participants received Divaza treatment
11346579|NCT04370028|FG000|Participant Flow|Divaza Treatment Group|All enrolled patients received Divaza 2 tablets 3 times per day for 12 weeks
11346580|NCT04370028|OG000|Outcome|Divaza Treatment Group|All analyzed participants received Divaza treatment 2 tablets 3 times per day for 12 weeks
11346581|NCT04370028|OG000|Outcome|Young Patients<35 yo|Young Patients<35 yo treated with Divaza
11346582|NCT04370028|OG001|Outcome|Middle-aged Patients 35-59 yo|Middle-aged patients 35-59 yo treated with Divaza
11346583|NCT04370028|OG002|Outcome|Elderly Patients 60-75 yo|Elderly patients 60-75 yo treated with Divaza
11346584|NCT04370028|OG003|Outcome|Senile Patients 75-90 yo|Senile patients 75-90 yo received Divaza
11346585|NCT04370028|OG000|Outcome|Female|Female patients treated with Divaza
11346586|NCT04370028|OG001|Outcome|Male|Male patients treated with Divaza
11346587|NCT04370028|OG000|Outcome|Divaza Treatment Group|All enrolled patients received Divaza 2 tablets 3 times per day for 12 weeks
11346588|NCT04370028|EG000|Reported Event|Divaza Treatment Group|All enrolled patients received Divaza 2 tablets 3 times per day for 12 weeks
11346589|NCT04363736|BG000|Baseline|TCZ 4 mg/kg|Participants received intravenous (IV) tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
11346590|NCT04363736|BG001|Baseline|TCZ 8 mg/kg|Participants received IV tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
11346591|NCT04363736|BG002|Baseline|Total|Total of all reporting groups
11346592|NCT04363736|FG000|Participant Flow|TCZ 4 mg/kg|Participants received intravenous (IV) tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
11346593|NCT04363736|FG001|Participant Flow|TCZ 8 mg/kg|Participants received IV tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
11346594|NCT04363736|OG000|Outcome|TCZ 4 mg/kg|Participants received intravenous (IV) tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
11346595|NCT04363736|OG001|Outcome|TCZ 8 mg/kg|Participants received IV tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
11346596|NCT04363736|EG000|Reported Event|TCZ 4 mg/kg|Participants received intravenous (IV) tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
11346597|NCT04363736|EG001|Reported Event|TCZ 8 mg/kg|Participants received IV tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
11348575|NCT04161807|FG000|Participant Flow|Nerivio Device Treatment|"participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started~Nerivio: The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
11346598|NCT04366583|BG000|Baseline|Argon Plasma Coagulation Plus Distilled Water Injection|"The patients in this group received Argon plasma coagulation therapy, PSD-60/Endoplasma (Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period.~argon plasma coagulation: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)"
11346599|NCT04366583|BG001|Baseline|Hemoclipping Plus Distilled Water Injection|"The patients in this group received hemoclipping (Olympus HX 110/610, Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period.~hemoclipping: clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)"
11346600|NCT04366583|BG002|Baseline|Total|Total of all reporting groups
11346601|NCT04366583|FG000|Participant Flow|Argon Plasma Coagulation Plus Distilled Water Injection|"The patients in this group received Argon plasma coagulation therapy, PSD-60/Endoplasma (Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period.~argon plasma coagulation: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)"
11346602|NCT04366583|FG001|Participant Flow|Hemoclipping Plus Distilled Water Injection|"The patients in this group received hemoclipping (Olympus HX 110/610, Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period.~hemoclipping: clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)"
11346603|NCT04366583|OG000|Outcome|Argon Plasma Coagulation Plus Distilled Water Injection|"The patients in this group received Argon plasma coagulation therapy, PSD-60/Endoplasma (Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period.~argon plasma coagulation: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)"
11346604|NCT04366583|OG001|Outcome|Hemoclipping Plus Distilled Water Injection|"The patients in this group received hemoclipping (Olympus HX 110/610, Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period.~hemoclipping: clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)"
11346605|NCT04366583|EG000|Reported Event|Argon Plasma Coagulation Plus Distilled Water Injection|"The patients in this group received Argon plasma coagulation therapy, PSD-60/Endoplasma (Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period.~argon plasma coagulation: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)"
11346606|NCT04366583|EG001|Reported Event|Hemoclipping Plus Distilled Water Injection|"The patients in this group received hemoclipping (Olympus HX 110/610, Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period.~hemoclipping: clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)"
10976677|NCT00941733|OG000|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
11346607|NCT04365699|BG000|Baseline|Interventional Patients: AT-001|"Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.~AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team"
10976678|NCT00941733|OG001|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
10846092|NCT00272987|BG000|Baseline|Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
10976679|NCT00941733|EG000|Reported Event|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
10976680|NCT00941733|EG001|Reported Event|Standard PTA|Standard PTA balloon: Balloon Angioplasty
10976681|NCT00941798|BG000|Baseline|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
10976682|NCT00941798|BG001|Baseline|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
10976683|NCT00941798|BG002|Baseline|Total|Total of all reporting groups
11346608|NCT04365699|BG001|Baseline|Control Match Group 1|Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
11346609|NCT04365699|BG002|Baseline|Control Match Group 2|Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
11346610|NCT04365699|BG003|Baseline|Total|Total of all reporting groups
11346611|NCT04365699|FG000|Participant Flow|Interventional Patients: AT-001|"Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.~AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team"
11346612|NCT04365699|FG001|Participant Flow|Control Match Group 1|Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
11346613|NCT04365699|FG002|Participant Flow|Control Match Group 2|Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
11346614|NCT04365699|OG000|Outcome|Interventional Patients: AT-001|"Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.~AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team"
11346615|NCT04365699|OG001|Outcome|Control Match Group 1|Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
11346616|NCT04365699|OG002|Outcome|Control Match Group 2|Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
11346617|NCT04365699|EG000|Reported Event|Interventional Patients: AT-001|"Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.~AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team"
11346618|NCT04365699|EG001|Reported Event|Control Match Group 1|Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
11346619|NCT04365699|EG002|Reported Event|Control Match Group 2|Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
11346620|NCT04365153|BG000|Baseline|High Dose Intervention|"600 mg of canakinumab (8 mg/kg for patients </= 40 kg)~Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours"
11346621|NCT04365153|BG001|Baseline|Low Dose Intervention|"300 mg of canakinumab (4 mg/kg for patients </= 40 kg)~Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours"
11346622|NCT04365153|BG002|Baseline|Control|"Placebo~Placebos: 250 mL of 5% dextrose infused IV over 2 hours"
11346623|NCT04365153|BG003|Baseline|Total|Total of all reporting groups
11346624|NCT04365153|FG000|Participant Flow|High Dose Intervention|"600 mg of canakinumab (8 mg/kg for patients </= 40 kg)~Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours"
11346625|NCT04365153|FG001|Participant Flow|Low Dose Intervention|"300 mg of canakinumab (4 mg/kg for patients </= 40 kg)~Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours"
11346626|NCT04365153|FG002|Participant Flow|Control|"Placebo~Placebos: 250 mL of 5% dextrose infused IV over 2 hours"
11346627|NCT04365153|OG000|Outcome|High Dose Intervention|"600 mg of canakinumab (8 mg/kg for patients </= 40 kg)~Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours"
11346628|NCT04365153|OG001|Outcome|Low Dose Intervention|"300 mg of canakinumab (4 mg/kg for patients </= 40 kg)~Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours"
11346629|NCT04365153|OG002|Outcome|Control|Placebo: 250 mL of 5% dextrose infused IV over 2 hours
11346630|NCT04365153|OG002|Outcome|Control|"Placebo~Placebos: 250 mL of 5% dextrose infused IV over 2 hours"
11346631|NCT04365153|EG000|Reported Event|High Dose Intervention|"600 mg of canakinumab (8 mg/kg for patients </= 40 kg)~Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours"
11346632|NCT04365153|EG001|Reported Event|Low Dose Intervention|"300 mg of canakinumab (4 mg/kg for patients </= 40 kg)~Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours"
11346633|NCT04365153|EG002|Reported Event|Control|"Placebo~Placebos: 250 mL of 5% dextrose infused IV over 2 hours"
11346634|NCT04363879|BG000|Baseline|Endometrial Scratch With Pipelle Curette|"For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.~Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion."
11346635|NCT04363879|BG001|Baseline|Endometrial Scratch With Shepard Catheter|"For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.~Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00."
11346636|NCT04363879|BG002|Baseline|Total|Total of all reporting groups
11346637|NCT04363879|FG000|Participant Flow|Endometrial Scratch With Pipelle Curette|"For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.~Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion."
11346638|NCT04363879|FG001|Participant Flow|Endometrial Scratch With Shepard Catheter|"For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.~Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00."
11346639|NCT04363879|OG000|Outcome|Endometrial Scratch With Pipelle Curette|"For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.~Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion."
11346640|NCT04363879|OG001|Outcome|Endometrial Scratch With Shepard Catheter|"For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.~Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00."
11346641|NCT04363879|EG000|Reported Event|Endometrial Scratch With Pipelle Curette|"For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.~Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion."
11346642|NCT04363879|EG001|Reported Event|Endometrial Scratch With Shepard Catheter|"For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.~Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00."
11346643|NCT04362137|BG000|Baseline|Ruxolitinib 5 mg|Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
11346644|NCT04362137|BG001|Baseline|Placebo|Matching-image placebo for 14 days with possible extension of treatment to 28 days
11346645|NCT04362137|BG002|Baseline|Total|Total of all reporting groups
11346646|NCT04362137|FG000|Participant Flow|Ruxolitinib 5 mg|Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
11346647|NCT04362137|FG001|Participant Flow|Placebo|Matching-image placebo for 14 days with possible extension of treatment to 28 days
11346648|NCT04362137|OG000|Outcome|Ruxolitinib 5 mg|Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
11346649|NCT04362137|OG001|Outcome|Placebo|Matching-image placebo for 14 days with possible extension of treatment to 28 days
11346650|NCT04362137|EG000|Reported Event|Ruxolitinib 5 mg|Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
11346651|NCT04362137|EG001|Reported Event|Placebo|Matching-image placebo for 14 days with possible extension of treatment to 28 days
11346652|NCT04359771|BG000|Baseline|Yellow MPL|Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea
11346653|NCT04359771|BG001|Baseline|Diode MPL|Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
11346654|NCT04359771|BG002|Baseline|Total|Total of all reporting groups
11346655|NCT04359771|FG000|Participant Flow|Yellow MPL|Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea. One eye (right) of each participant was assigned to this group.
11346656|NCT04359771|FG001|Participant Flow|Diode MPL|Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea. One eye (left) of each participant was assigned to this group.
11346657|NCT04359771|OG000|Outcome|Yellow MPL|Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea
11346658|NCT04359771|OG001|Outcome|Diode MPL|Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
11346659|NCT04359771|EG000|Reported Event|Yellow MPL|Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea
11346660|NCT04359771|EG001|Reported Event|Diode MPL|Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
11346661|NCT04358991|BG000|Baseline|Subjects Included|20 patients meeting inclusion criteria were enrolled into the trial
11346662|NCT04358991|FG000|Participant Flow|Subjects Included|20 patients meeting inclusion criteria were enrolled into the trial
11346663|NCT04358991|OG000|Outcome|Subjects Included|20 patients meeting inclusion criteria were enrolled into the trial
11346664|NCT04358991|EG000|Reported Event|Subjects Included|20 patients meeting inclusion criteria were enrolled into the trial
11346665|NCT04358081|BG000|Baseline|Arm 1: Hydroxychloroquine + Aithromycin Placebo|Hydroxychloroquine 600mg o.d. as loading dose (Day 1) +followed by 200mg t.i.d was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin placebo o.d.
11346666|NCT04358081|BG001|Baseline|Arm 2: Hydroxychloroquine + Azithromycin|Hydroxychloroquine 600 mg o.d. as a loading dose (Day 1) followed by 200 mg t.i.d. was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin: 500 mg as a loading dose (Day 1) followed by 250 mg o.d. Day 2 - Day 5
11346667|NCT04358081|BG002|Baseline|Arm 3: Hydroxychloroquine Placebo + Azithromycin Placebo|Hydroxychloroquine placebo o.d. (day 1) followed by hydroxychloroquine placebo t.i.d Azythromycin placebo o.d.
11346668|NCT04358081|BG003|Baseline|Total|Total of all reporting groups
11346669|NCT04358081|FG000|Participant Flow|Arm 1: Hydroxychloroquine + Aithromycin Placebo|Hydroxychloroquine 600mg o.d. as loading dose (Day 1) +followed by 200mg t.i.d was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin placebo o.d.
11346670|NCT04358081|FG001|Participant Flow|Arm 2: Hydroxychloroquine + Azithromycin|Hydroxychloroquine 600 mg o.d. as a loading dose (Day 1) followed by 200 mg t.i.d. was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin: 500 mg as a loading dose (Day 1) followed by 250 mg o.d. Day 2 - Day 5
11346671|NCT04358081|FG002|Participant Flow|Arm 3: Hydroxychloroquine Placebo + Azithromycin Placebo|Hydroxychloroquine placebo o.d. (day 1) followed by hydroxychloroquine placebo t.i.d Azythromycin placebo o.d.
11346672|NCT04358081|OG000|Outcome|Arm 1: Hydroxychloroquine + Aithromycin Placebo|Hydroxychloroquine 600mg o.d. as loading dose (Day 1) +followed by 200mg t.i.d was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin placebo o.d.
11346673|NCT04358081|OG001|Outcome|Arm 2: Hydroxychloroquine + Azithromycin|Hydroxychloroquine 600 mg o.d. as a loading dose (Day 1) followed by 200 mg t.i.d. was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin: 500 mg as a loading dose (Day 1) followed by 250 mg o.d. Day 2 - Day 5
11346674|NCT04358081|OG002|Outcome|Arm 3: Hydroxychloroquine Placebo + Azithromycin Placebo|Hydroxychloroquine placebo o.d. (day 1) followed by hydroxychloroquine placebo t.i.d Azythromycin placebo o.d.
11346675|NCT04358081|OG000|Outcome|Arm 1: Hydroxychloroquine + Aithromycin Placebo|Hydroxychloroquine 600mg o.d. as loading dose (Day 1) +followed by 200mg t.i.d was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin (AZI) placebo o.d.
11346676|NCT04358081|EG000|Reported Event|Hydroxychloroquine + Aithromycin Placebo|HCQ
11346677|NCT04358081|EG001|Reported Event|Hydroxychloroquine + Azithromycin|HCQ + AZI
11346678|NCT04358081|EG002|Reported Event|Hydroxychloroquine Placebo + Azithromycin Placebo|HCG + AZI + Placebo
11346679|NCT04358081|EG003|Reported Event|Total|Total
11346680|NCT04356937|BG000|Baseline|Tocilizumab|"Review effect of Tocilizumab on multi-organ dysfunction in a phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection.~Participants will receive an intravenous (IV) injection of 8 mg/kg (not to exceed 800 mg) tocilizumab. Specifically, as compared to placebo, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory measures.~Tocilizumab: Patients will receive the standard treatment for COVID-19 per MGH guidance and also be randomized (2:1) to one of the following arms:~Tocilizumab 8mg x 1~Standard of care/Placebo"
11346681|NCT04356937|BG001|Baseline|Standard of Care Plus Placebo|"Participants will receive an placebo intravenous (IV) injection of 8 mg/kg (not to exceed 800 mg).Specifically, as compared to placebo, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory measures.~Placebos: Patients will receive the standard treatment for COVID-19 per MGH guidance and also be randomized (2:1) to one of the following arms:~Tocilizumab 8mg x 1~Standard of care/Placebo"
11346682|NCT04356937|BG002|Baseline|Total|Total of all reporting groups
11346683|NCT04356937|FG000|Participant Flow|Tocilizumab|Standard care plus a single dose of tocilizumab (8 mg/kg administered intravenously, not to exceed 800 mg)
11346684|NCT04356937|FG001|Participant Flow|Placebo|Standard care plus placebo
11346685|NCT04356937|OG000|Outcome|Tocilizumab|Standard care plus a single dose of tocilizumab (8 mg/kg administered intravenously, not to exceed 800 mg)
11346686|NCT04356937|OG001|Outcome|Placebo|Standard care plus placebo
11346687|NCT04356937|EG000|Reported Event|Tocilizumab|Standard care plus a single dose of tocilizumab (8 mg/kg administered intravenously, not to exceed 800 mg)
11346688|NCT04356937|EG001|Reported Event|Placebo|Standard care plus placebo
11346689|NCT04355663|BG000|Baseline|Motor Program Activating Therapy|"MPAT is method developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centered. Somatosensory (manual and verbal) stimuli are then applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when laying, sitting, standing up or moving forward.~16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346690|NCT04355663|BG001|Baseline|Vojta's Reflex Locomotion|"VRL is a standard approach for patients with MS in the Czech Republic. In the therapy, global patterns of the reflex locomotion are activated by stimulation of specific zones, with the individual placed in a precisely determined initial position (supine, prone and side laying, low kneeling position).~16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346691|NCT04355663|BG002|Baseline|Functional Electric Stimulation|"Functional electric stimulation in the postural corrected position was developed at our workplace. Participants first underwent individual two-hour session consisting of postural correction using MPAT and the device (The WalkAide® System, Innovative Neurotronics Inc., 4999 Aircenter Circle, Suite 103 Reno, NV 89502, USA) programming (28). Patients received the device to use as much as they felt they were able to during their normal daily living activities thereafter.~Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346692|NCT04355663|BG003|Baseline|Total|Total of all reporting groups
11346693|NCT04355663|FG000|Participant Flow|Motor Program Activating Therapy|"MPAT is method developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centered. Somatosensory (manual and verbal) stimuli are then applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when laying, sitting, standing up or moving forward.~16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346694|NCT04355663|FG001|Participant Flow|Vojta's Reflex Locomotion|"VRL is a standard approach for patients with MS in the Czech Republic. In the therapy, global patterns of the reflex locomotion are activated by stimulation of specific zones, with the individual placed in a precisely determined initial position (supine, prone and side laying, low kneeling position).~16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346695|NCT04355663|FG002|Participant Flow|Functional Electric Stimulation|"Functional electric stimulation in the postural corrected position was developed at our workplace. Participants first underwent individual two-hour session consisting of postural correction using MPAT and the device (The WalkAide® System, Innovative Neurotronics Inc., 4999 Aircenter Circle, Suite 103 Reno, NV 89502, USA) programming (28). Patients received the device to use as much as they felt they were able to during their normal daily living activities thereafter.~Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346696|NCT04355663|OG000|Outcome|Motor Program Activating Therapy|"MPAT is method developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centered. Somatosensory (manual and verbal) stimuli are then applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when laying, sitting, standing up or moving forward.~16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346697|NCT04355663|OG001|Outcome|Vojta's Reflex Locomotion|"VRL is a standard approach for patients with MS in the Czech Republic. In the therapy, global patterns of the reflex locomotion are activated by stimulation of specific zones, with the individual placed in a precisely determined initial position (supine, prone and side laying, low kneeling position).~16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346698|NCT04355663|OG002|Outcome|Functional Electric Stimulation|"Functional electric stimulation in the postural corrected position was developed at our workplace. Participants first underwent individual two-hour session consisting of postural correction using MPAT and the device (The WalkAide® System, Innovative Neurotronics Inc., 4999 Aircenter Circle, Suite 103 Reno, NV 89502, USA) programming (28). Patients received the device to use as much as they felt they were able to during their normal daily living activities thereafter.~Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346699|NCT04355663|EG000|Reported Event|Vojta's Reflex Locomotion|"VRL is a standard approach for patients with MS in the Czech Republic. In the therapy, global patterns of the reflex locomotion are activated by stimulation of specific zones, with the individual placed in a precisely determined initial position (supine, prone and side laying, low kneeling position).~16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11348576|NCT04161807|OG000|Outcome|Nerivio Device Treatment|"participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started~Nerivio: The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
10855547|NCT00329784|BG001|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
10855548|NCT00329784|BG002|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
10855549|NCT00329784|BG003|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
10855550|NCT00329784|BG004|Baseline|Total|Total of all reporting groups
10855551|NCT00329784|FG000|Participant Flow|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
10855552|NCT00329784|FG001|Participant Flow|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
10855553|NCT00329784|FG002|Participant Flow|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
10855554|NCT00329784|FG003|Participant Flow|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
10855555|NCT00329784|OG000|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
11346700|NCT04355663|EG001|Reported Event|Motor Program Activating Therapy|"MPAT is method developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centered. Somatosensory (manual and verbal) stimuli are then applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when laying, sitting, standing up or moving forward.~16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346701|NCT04355663|EG002|Reported Event|Functional Electric Stimulation|"Functional electric stimulation in the postural corrected position was developed at our workplace. Participants first underwent individual two-hour session consisting of postural correction using MPAT and the device (The WalkAide® System, Innovative Neurotronics Inc., 4999 Aircenter Circle, Suite 103 Reno, NV 89502, USA) programming (28). Patients received the device to use as much as they felt they were able to during their normal daily living activities thereafter.~Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions."
11346702|NCT04354870|BG000|Baseline|HCQ Group|"Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ~Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days"
10855556|NCT00329784|OG001|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
11346703|NCT04354870|BG001|Baseline|Control Group|approximately 50 HCW who choose not to be provided HCQ
11346704|NCT04354870|BG002|Baseline|Total|Total of all reporting groups
11346705|NCT04354870|FG000|Participant Flow|HCQ Group|"Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ~Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days"
10855557|NCT00329784|OG002|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
10855558|NCT00329784|OG003|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
10855559|NCT00329784|OG000|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
10855560|NCT00329784|OG001|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
11346706|NCT04354870|FG001|Participant Flow|Control Group|approximately 50 HCW who choose not to be provided HCQ
11346707|NCT04354870|OG000|Outcome|HCQ Group|"Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ~Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days"
11346708|NCT04354870|OG001|Outcome|Control Group|approximately 50 HCW who choose not to be provided HCQ
11346709|NCT04354870|EG000|Reported Event|HCQ Group|"Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ~Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days"
11346710|NCT04354870|EG001|Reported Event|Control Group|approximately 50 HCW who choose not to be provided HCQ
11346711|NCT04350307|BG000|Baseline|22-Gauge Arm|"Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle~22-gauge needle: 22-gauge Quincke needle used for epidural injection"
11346712|NCT04350307|BG001|Baseline|25-Gauge Arm|"Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle~25-gauge needle: 25-gauge Quincke needle used for epidural injection"
11346713|NCT04350307|BG002|Baseline|Total|Total of all reporting groups
11346714|NCT04350307|FG000|Participant Flow|22-Gauge Arm|"Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle~22-gauge needle: 22-gauge Quincke needle used for epidural injection"
11346715|NCT04350307|FG001|Participant Flow|25-Gauge Arm|"Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle~25-gauge needle: 25-gauge Quincke needle used for epidural injection"
11346716|NCT04350307|OG000|Outcome|22-Gauge Arm|"Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle~22-gauge needle: 22-gauge Quincke needle used for epidural injection"
11222986|NCT02350127|OG001|Outcome|Delayed Start|Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
11346717|NCT04350307|OG001|Outcome|25-Gauge Arm|"Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle~25-gauge needle: 25-gauge Quincke needle used for epidural injection"
11346718|NCT04350307|EG000|Reported Event|22-Gauge Arm|"Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle~22-gauge needle: 22-gauge Quincke needle used for epidural injection"
11346719|NCT04350307|EG001|Reported Event|25-Gauge Arm|"Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle~25-gauge needle: 25-gauge Quincke needle used for epidural injection"
10976684|NCT00941798|FG000|Participant Flow|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
11346720|NCT04352660|BG000|Baseline|Injection Group|"MMC delivered by preoperative subconjunctival injection~Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection"
11346721|NCT04352660|BG001|Baseline|Sponge Group|"MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges~Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges"
11346722|NCT04352660|BG002|Baseline|Total|Total of all reporting groups
11346723|NCT04352660|FG000|Participant Flow|Injection Group|"MMC delivered by preoperative subconjunctival injection~Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection"
11346724|NCT04352660|FG001|Participant Flow|Sponge Group|"MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges~Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges"
11346725|NCT04352660|OG000|Outcome|Injection Group|"MMC delivered by preoperative subconjunctival injection~Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection"
11346726|NCT04352660|OG001|Outcome|Sponge Group|"MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges~Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges"
11346727|NCT04352660|EG000|Reported Event|Injection Group|"MMC delivered by preoperative subconjunctival injection~Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection"
11346728|NCT04352660|EG001|Reported Event|Sponge Group|"MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges~Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges"
11346729|NCT04350788|BG000|Baseline|Survivorship Care Plan (SCP)|"The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),~Survivorship Care Plan: Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care"
11346730|NCT04350788|BG001|Baseline|Enhanced SCP (ESCP)|"ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.~Enhanced Survivorship Care Plan: In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support"
11346731|NCT04350788|BG002|Baseline|Total|Total of all reporting groups
11346732|NCT04350788|FG000|Participant Flow|Survivorship Care Plan (SCP)|"The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),~Survivorship Care Plan: Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care"
11348577|NCT04161807|EG000|Reported Event|Nerivio Device Treatment|"participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started~Nerivio: The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
10855561|NCT00329784|EG000|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
10855562|NCT00329784|EG001|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
10855563|NCT00329784|EG002|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
10855564|NCT00329784|EG003|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
10855565|NCT00329797|BG000|Baseline|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
10855566|NCT00329797|BG001|Baseline|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
10855567|NCT00329797|BG002|Baseline|Total|Total of all reporting groups
10855568|NCT00329797|FG000|Participant Flow|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and luteinizing hormone-releasing hormone (LHRH) therapy.
10855569|NCT00329797|FG001|Participant Flow|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
10855570|NCT00329797|OG000|Outcome|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
10855571|NCT00329797|OG001|Outcome|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
10855572|NCT00329797|EG000|Reported Event|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
10855573|NCT00329797|EG001|Reported Event|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
10855574|NCT00329836|BG000|Baseline|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
10855575|NCT00329836|FG000|Participant Flow|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
10855576|NCT00329836|OG000|Outcome|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
10855577|NCT00329836|EG000|Reported Event|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
10855578|NCT00329849|BG000|Baseline|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10855579|NCT00329849|BG001|Baseline|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
10855580|NCT00329849|BG002|Baseline|Total|Total of all reporting groups
10855581|NCT00329849|FG000|Participant Flow|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10855582|NCT00329849|FG001|Participant Flow|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
10855583|NCT00329849|OG000|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10855584|NCT00329849|OG001|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
10855585|NCT00329849|OG000|Outcome|MenACWY-CRM_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10855586|NCT00329849|OG001|Outcome|MenACWY-PS_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
10855587|NCT00329849|OG002|Outcome|MenACWY-CRM_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10855588|NCT00329849|OG003|Outcome|MenACWY-PS_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
10855589|NCT00329849|EG000|Reported Event|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10855590|NCT00329849|EG001|Reported Event|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
10855591|NCT00329901|BG000|Baseline|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
10855592|NCT00329901|BG001|Baseline|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
10855593|NCT00329901|BG002|Baseline|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
10855594|NCT00329901|BG003|Baseline|Total|Total of all reporting groups
10855595|NCT00329901|FG000|Participant Flow|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
10855596|NCT00329901|FG001|Participant Flow|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
11346733|NCT04350788|FG001|Participant Flow|Enhanced SCP (ESCP)|"ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.~Enhanced Survivorship Care Plan: In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support"
11346734|NCT04350788|OG000|Outcome|Overall|Enrollment rate is calculated before randomization without arms.
11346735|NCT04350788|OG000|Outcome|Survivorship Care Plan (SCP)|"The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),~Survivorship Care Plan: Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care"
11346736|NCT04350788|OG001|Outcome|Enhanced SCP (ESCP)|"ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.~Enhanced Survivorship Care Plan: In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support"
11346737|NCT04350788|OG000|Outcome|Survivorship Care Plan (SCP): Patient|"The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),~Survivorship Care Plan: Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care"
11346738|NCT04350788|OG001|Outcome|Enhanced SCP (ESCP): Patient|"ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.~Enhanced Survivorship Care Plan: In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support"
11346739|NCT04350788|OG002|Outcome|Survivorship Care Plan (SCP): Partner|"The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),~Survivorship Care Plan: Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care"
11346740|NCT04350788|OG003|Outcome|Enhanced SCP (ESCP): Partner|"ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.~Enhanced Survivorship Care Plan: In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support"
11346741|NCT04350788|EG000|Reported Event|Survivorship Care Plan (SCP)|"The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),~Survivorship Care Plan: Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care"
11346742|NCT04350788|EG001|Reported Event|Enhanced SCP (ESCP)|"ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.~Enhanced Survivorship Care Plan: In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support"
11346743|NCT04349917|BG000|Baseline|Methylphenidate, Then Placebo|Participants received a single, low dose of methylphenidate (0.3 mg/kg) before the first MRI scan. Approximately one week later, participants received a matching placebo pill before the second MRI scan.
11346744|NCT04349917|BG001|Baseline|Placebo, Then Methylphenidate|Participants received a matching placebo pill before the first MRI scan. Approximately one week later, participants received a single, low dose of methylphenidate (0.3 mg/kg) before the second MRI scan.
11346745|NCT04349917|BG002|Baseline|Total|Total of all reporting groups
11346746|NCT04349917|FG000|Participant Flow|Methylphenidate, Then Placebo|Participants received a single, low dose of methylphenidate (0.3 mg/kg) before the first MRI scan. Approximately one week later, participants received a matching placebo pill before the second MRI scan.
11346747|NCT04349917|FG001|Participant Flow|Placebo, Then Methylphenidate|Participants received a matching placebo pill before the first MRI scan. Approximately one week later, participants received a single, low dose of methylphenidate (0.3 mg/kg) before the second MRI scan.
11346748|NCT04349917|OG000|Outcome|Methylphenidate|Participants received a single, low dose of methylphenidate (0.3 mg/kg) before MRI scan
11346749|NCT04349917|OG001|Outcome|Placebo|Participants received a matching placebo pill before MRI scan.
11346750|NCT04349917|OG000|Outcome|Methylphenidate and Placebo|Participants received a single, low dose of methylphenidate (0.3 mg/kg) before one MRI scan and a matching placebo pill before a separate MRI scan.
11346751|NCT04349917|EG000|Reported Event|Methylphenidate|Participants received a single, low dose of methylphenidate (0.3 mg/kg) before MRI scan
11346752|NCT04349917|EG001|Reported Event|Placebo|Participants received a matching placebo pill before MRI scan.
11346753|NCT04348851|BG000|Baseline|4-Week Intervention|"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/).~Caregiver problem-solving: Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"
11346754|NCT04348851|BG001|Baseline|8-Week Intervention|"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/).~Caregiver problem-solving: Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"
11346755|NCT04348851|BG002|Baseline|8-Week Attention Control|"The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare provider.~Attention Control: The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare"
11346756|NCT04348851|BG003|Baseline|Standard Care|Caregivers receiving standard of care
11346757|NCT04348851|BG004|Baseline|Total|Total of all reporting groups
11346758|NCT04348851|FG000|Participant Flow|4-Week Intervention|"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/).~Caregiver problem-solving: Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"
11346759|NCT04348851|FG001|Participant Flow|8-Week Intervention|"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/).~Caregiver problem-solving: Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"
11346760|NCT04348851|FG002|Participant Flow|8-Week Attention Control|"The Registered Nurses (RNs) will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare provider.~Attention Control: The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare"
11346761|NCT04348851|FG003|Participant Flow|Standard Care|Caregivers receiving standard of care
11346762|NCT04348851|OG000|Outcome|4-Week Intervention|"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/).~Caregiver problem-solving: Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"
11348578|NCT04161144|BG000|Baseline|Rapamycin 15mg (Sirolimus)|"Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.~sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit."
11346763|NCT04348851|OG001|Outcome|8-Week Intervention|"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/).~Caregiver problem-solving: Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"
11346764|NCT04348851|OG002|Outcome|8-Week Attention Control|"The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare provider.~Attention Control: The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare"
11346765|NCT04348851|OG003|Outcome|Standard Care|Caregivers receiving standard of care
11346766|NCT04348851|EG000|Reported Event|4-Week Intervention|"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/).~Caregiver problem-solving: Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"
11346767|NCT04348851|EG001|Reported Event|8-Week Intervention|"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/).~Caregiver problem-solving: Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"
11346768|NCT04348851|EG002|Reported Event|8-Week Attention Control|"The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare provider.~Attention Control: The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare"
11346769|NCT04348851|EG003|Reported Event|Standard Care|Caregivers receiving standard of care
11346770|NCT04348357|BG000|Baseline|Traditional Visit|"Patients come to the office for a traditional postoperative visit~Office visit: Patient comes to the office to receive routine postoperative care"
11346771|NCT04348357|BG001|Baseline|Tele-medicine|"Patients receive postoperative care via telemedicine~Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)"
11346772|NCT04348357|BG002|Baseline|Total|Total of all reporting groups
11346773|NCT04348357|FG000|Participant Flow|Traditional Visit|"Patients come to the office for a traditional postoperative visit~Office visit: Patient comes to the office to receive routine postoperative care"
11346774|NCT04348357|FG001|Participant Flow|Tele-medicine|"Patients receive postoperative care via telemedicine~Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)"
11346775|NCT04348357|OG000|Outcome|Traditional Visit|"Patients come to the office for a traditional postoperative visit~Office visit: Patient comes to the office to receive routine postoperative care"
11346776|NCT04348357|OG001|Outcome|Tele-medicine|"Patients receive postoperative care via telemedicine~Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)"
11346777|NCT04348357|EG000|Reported Event|Traditional Visit|"Patients come to the office for a traditional postoperative visit~Office visit: Patient comes to the office to receive routine postoperative care"
11346778|NCT04348357|EG001|Reported Event|Tele-medicine|"Patients receive postoperative care via telemedicine~Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)"
10976685|NCT00941798|FG001|Participant Flow|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
11346779|NCT04346199|BG000|Baseline|Acalabrutinib + BSC|Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines.
11346780|NCT04346199|BG001|Baseline|BSC Alone|Participants received best supportive care per the discretion of the Investigator and institutional guidelines.
11346781|NCT04346199|BG002|Baseline|Total|Total of all reporting groups
10855597|NCT00329901|FG002|Participant Flow|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
10855598|NCT00329901|OG000|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
11346782|NCT04346199|FG000|Participant Flow|Acalabrutinib + BSC|Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines.
11346783|NCT04346199|FG001|Participant Flow|BSC Alone|Participants received best supportive care per the discretion of the Investigator and institutional guidelines.
11346784|NCT04346199|OG000|Outcome|Acalabrutinib + BSC|Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines.
11346785|NCT04346199|OG001|Outcome|BSC Alone|Participants received best supportive care per the discretion of the Investigator and institutional guidelines.
11346786|NCT04346199|EG000|Reported Event|Acalabrutinib + BSC|Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines.
11346787|NCT04346199|EG001|Reported Event|BSC Alone|Participants received best supportive care per the discretion of the Investigator and institutional guidelines.
11346788|NCT04345653|BG000|Baseline|Study Arm - Hydroxychloroquine Sulfate (HCQ)|"HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth~Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ."
11346789|NCT04345653|FG000|Participant Flow|Study Arm - Hydroxychloroquine Sulfate (HCQ)|"HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth~Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ."
11346790|NCT04345653|OG000|Outcome|Study Arm|"HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth~Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ."
11346791|NCT04345653|OG000|Outcome|Study Arm - Hydroxychloroquine Sulfate (HCQ)|"HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth~Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ."
11346792|NCT04345653|EG000|Reported Event|Study Arm - Hydroxychloroquine Sulfate (HCQ)|"HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth~Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ."
11346793|NCT04343261|BG000|Baseline|COVID-19 Patients Treated With Convalescent Plasma|"Severely ill COVID-19 patients treated with convalescent plasma~Convalescent Plasma: treatment with 2 Units of convalescent plasma"
11346794|NCT04343261|FG000|Participant Flow|COVID-19 Patients Treated With Convalescent Plasma|"Severely ill COVID-19 patients treated with convalescent plasma~Convalescent Plasma: treatment with 2 Units of convalescent plasma"
11346795|NCT04343261|OG000|Outcome|COVID-19 Patients Treated With Convalescent Plasma|"Severely ill COVID-19 patients treated with convalescent plasma~Convalescent Plasma: treatment with 2 Units of convalescent plasma"
11346796|NCT04343261|EG000|Reported Event|COVID-19 Patients Treated With Convalescent Plasma|"Severely ill COVID-19 patients treated with convalescent plasma~Convalescent Plasma: treatment with 2 Units of convalescent plasma"
11346797|NCT04343222|BG000|Baseline|Group A: Bromfenac Then Artificial Tears|"Participant receives 1 drop of topical Bromfenac 0.09% 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.~Bromfenac: An NSAID used to treat eye pain and swelling~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346798|NCT04343222|BG001|Baseline|Group B: Artificial Tears Then Bromfenac|"Participant receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of topical Bromfenac 0.09% immediately after the injection and wash.~Bromfenac: An NSAID used to treat eye pain and swelling~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346799|NCT04343222|BG002|Baseline|Group C: Artificial Tears Then Artificial Tears|"Participants receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346800|NCT04343222|BG003|Baseline|Total|Total of all reporting groups
11346801|NCT04343222|FG000|Participant Flow|Group A: Bromfenac Then Artificial Tears|"Participant receives 1 drop of topical Bromfenac 0.09% 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.~Bromfenac: An NSAID used to treat eye pain and swelling~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346802|NCT04343222|FG001|Participant Flow|Group B: Artificial Tears Then Bromfenac|"Participant receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of topical Bromfenac 0.09% immediately after the injection and wash.~Bromfenac: An NSAID used to treat eye pain and swelling~Artificial tears: eye drops to lubricate the eye and maintain moisture"
10855599|NCT00329901|OG001|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
10855600|NCT00329901|OG000|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
10855601|NCT00329901|OG000|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
10855602|NCT00329901|OG001|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
10855603|NCT00329901|OG001|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
10855604|NCT00329901|OG002|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
10855605|NCT00329901|EG000|Reported Event|Tdap + MenACWY-CRM|Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
11346803|NCT04343222|FG002|Participant Flow|Group C: Artificial Tears Then Artificial Tears|"Participants receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346804|NCT04343222|OG000|Outcome|Group A: Bromfenac Then Artificial Tears|"Participant receives 1 drop of topical Bromfenac 0.09% 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.~Bromfenac: An NSAID used to treat eye pain and swelling~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346805|NCT04343222|OG001|Outcome|Group B: Artificial Tears Then Bromfenac|"Participant receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of topical Bromfenac 0.09% immediately after the injection and wash.~Bromfenac: An NSAID used to treat eye pain and swelling~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346806|NCT04343222|OG002|Outcome|Group C: Artificial Tears Then Artificial Tears|"Participants receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346807|NCT04343222|EG000|Reported Event|Group A: Bromfenac Then Artificial Tears|"Participant receives 1 drop of topical Bromfenac 0.09% 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.~Bromfenac: An NSAID used to treat eye pain and swelling~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346808|NCT04343222|EG001|Reported Event|Group B: Artificial Tears Then Bromfenac|"Participant receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of topical Bromfenac 0.09% immediately after the injection and wash.~Bromfenac: An NSAID used to treat eye pain and swelling~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346809|NCT04343222|EG002|Reported Event|Group C: Artificial Tears Then Artificial Tears|"Participants receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.~Artificial tears: eye drops to lubricate the eye and maintain moisture"
11346810|NCT04343092|BG000|Baseline|Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)|IVM 0.2mg /kg single dose at admisison day HCQ 400mg BID in the first day then 200mg BID for 5 days AZT 500mg in the first day then 250mg for 5 days
11346811|NCT04343092|FG000|Participant Flow|Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)|"Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily~Ivermectin (IVM): Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly"
10848851|NCT00292045|BG000|Baseline|NY-ESO-1 Protein + CpG 7909|Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
11346812|NCT04343092|OG000|Outcome|IVM+HCQ+AZT Group|Time to cure in IVM+HCQ+AZT group and evaluated by measuring time from admission of the patient to the hospital till discharge after being free of symptoms and negative PCR swab. Once nasopharyngeal and oropharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed.
11346813|NCT04343092|EG000|Reported Event|IVM+HCQ+AZT Group|Assessment of any adverse events in 0.2mg IVM single dose on admission day +HCQ 400mg BID in the first day then 200mg BID for 5 days+AZT 500mg in the first day then 250mg for 5 days
11346814|NCT04342663|BG000|Baseline|Fluvoxamine|"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.~Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated."
11346815|NCT04342663|BG001|Baseline|Placebo|"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.~Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated."
11346816|NCT04342663|BG002|Baseline|Total|Total of all reporting groups
11346817|NCT04342663|FG000|Participant Flow|Fluvoxamine|"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.~Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated."
11346818|NCT04342663|FG001|Participant Flow|Placebo|"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.~Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated."
11346819|NCT04342663|OG000|Outcome|Fluvoxamine|"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.~Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated."
11346820|NCT04342663|OG001|Outcome|Placebo|"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.~Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated."
10976686|NCT00941798|OG000|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
10976687|NCT00941798|OG001|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
11346821|NCT04342663|EG000|Reported Event|Fluvoxamine|"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.~Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated."
11346822|NCT04342663|EG001|Reported Event|Placebo|"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.~Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated."
11346823|NCT04342897|BG000|Baseline|LY3127804|Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
11346824|NCT04342897|BG001|Baseline|Placebo|Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
11346825|NCT04342897|BG002|Baseline|Total|Total of all reporting groups
11346826|NCT04342897|FG000|Participant Flow|LY3127804|Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.
11346827|NCT04342897|FG001|Participant Flow|Placebo|Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
11346828|NCT04342897|OG000|Outcome|LY3127804|Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
11346829|NCT04342897|OG001|Outcome|Placebo|Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
11346830|NCT04342897|EG000|Reported Event|LY3127804|Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
11346831|NCT04342897|EG001|Reported Event|Placebo|Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
11346832|NCT04342130|BG000|Baseline|30 mg Morphine|"People with low back pain who were given and oral dose of 30 mg morphine.~Morphine: 30 mg oral tablet"
11346833|NCT04342130|FG000|Participant Flow|30 mg Morphine|"People with low back pain who were given and oral dose of 30 mg morphine.~Morphine: 30 mg oral tablet"
11346834|NCT04342130|OG000|Outcome|30 mg Morphine|"People with low back pain who were given and oral dose of 30 mg morphine.~Morphine: 30 mg oral tablet"
11346835|NCT04342130|EG000|Reported Event|30 mg Morphine|"People with low back pain who were given and oral dose of 30 mg morphine.~Morphine: 30 mg oral tablet"
11346836|NCT04340557|BG000|Baseline|Group A (Study Drug+SOC)|"Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.~Losartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days."
11346837|NCT04340557|BG001|Baseline|Group B (SOC)|Standard of Care
11346838|NCT04340557|BG002|Baseline|Total|Total of all reporting groups
11346839|NCT04340557|FG000|Participant Flow|Losartan + Standard of Care|"Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.~Losartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days."
11346840|NCT04340557|FG001|Participant Flow|Standard of Care|Patient will receive the hospital Standard of Care for their condition
11346841|NCT04340557|OG000|Outcome|Group A (Study Drug+SOC)|"Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.~Losartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days."
11346842|NCT04340557|OG001|Outcome|Group B (SOC)|Standard of Care
11346843|NCT04340557|EG000|Reported Event|Group A (Study Drug+SOC)|"Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.~Losartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days."
11346844|NCT04340557|EG001|Reported Event|Group B (SOC)|Standard of Care
11346845|NCT04339972|BG000|Baseline|Active LIFUP Followed by Sham LIFUP|"Real LIFUP is delivered to the participant during this condition.~LIFUP: Low Intensity Focused Ultrasound Pulsation (LIFUP) is an interesting new form of brain stimulation that may be possible to stimulate non-invasively, safely, deep in the brain with focal precision."
11346846|NCT04339972|BG001|Baseline|Sham LIFUP Followed by Active LIFUP|"Sham LIFUP (device turned on but no sonication delivered) during this condition~Sham LIFUP: The same as LIFUP but the device is not turned on and the subject does not receive any ultrasound."
11346847|NCT04339972|BG002|Baseline|Total|Total of all reporting groups
11346848|NCT04339972|FG000|Participant Flow|Active LIFUP Followed by Sham LIFUP|"Real LIFUP is delivered to the participant during this condition.~LIFUP: Low Intensity Focused Ultrasound Pulsation (LIFUP) is an interesting new form of brain stimulation that may be possible to stimulate non-invasively, safely, deep in the brain with focal precision."
11346849|NCT04339972|FG001|Participant Flow|Sham LIFUP Followed by Active LIFUP|"Sham LIFUP (device turned on but no sonication delivered) during this condition~Sham LIFUP: The same as LIFUP but the device is not turned on and the subject does not receive any ultrasound."
11346850|NCT04339972|OG000|Outcome|Active LIFUP|Real LIFUP is delivered to the participant for either visit 1 or visit 2.
10855606|NCT00329901|EG001|Reported Event|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
10855607|NCT00329901|EG002|Reported Event|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
11346851|NCT04339972|OG001|Outcome|Sham LIFUP|Sham LIFUP is delivered to the participant for visit 1 or visit 2.
10855608|NCT00330161|BG000|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
10855609|NCT00330161|FG000|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
10855610|NCT00330161|OG000|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
10855611|NCT00330161|EG000|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
10855612|NCT00330174|BG000|Baseline|Acamprosate|Acamprosate tablets
10855613|NCT00330174|BG001|Baseline|Placebo|Matching placebo tablets
11346852|NCT04339972|EG000|Reported Event|Active LIFUP|Real LIFUP is delivered to the participant for visit 1 or visit 2.
11346853|NCT04339972|EG001|Reported Event|Sham LIFUP|Sham LIFUP is delivered to the participant for visit 1 or visit 2.
11346854|NCT04339296|BG000|Baseline|Intervention Group|"Intervention group included medication management with Spencer.~Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition speciﬁc questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada."
11346855|NCT04339296|BG001|Baseline|Control Group|The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
11346856|NCT04339296|BG002|Baseline|Total|Total of all reporting groups
11346857|NCT04339296|FG000|Participant Flow|Intervention Group|"Intervention group included medication management with Spencer.~Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition speciﬁc questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada."
11346858|NCT04339296|FG001|Participant Flow|Control Group|The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
11346859|NCT04339296|OG000|Outcome|Intervention Group|"Intervention group included medication management with Spencer.~Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition speciﬁc questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada."
11346860|NCT04339296|OG001|Outcome|Control Group|The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
11346861|NCT04339296|EG000|Reported Event|Intervention Group|"Intervention group included medication management with Spencer.~Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition speciﬁc questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada."
11346862|NCT04339296|EG001|Reported Event|Control Group|The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
10855614|NCT00330174|BG002|Baseline|Total|Total of all reporting groups
10855615|NCT00330174|FG000|Participant Flow|Acamprosate|Acamprosate tablets
10855616|NCT00330174|FG001|Participant Flow|Placebo|Matching placebo tablets
10855617|NCT00330174|OG000|Outcome|Acamprosate|Acamprosate tablets
10855618|NCT00330174|OG001|Outcome|Placebo|Matching placebo tablets
10855619|NCT00330174|EG000|Reported Event|Acamprosate|Acamprosate tablets
10855620|NCT00330174|EG001|Reported Event|Placebo|Matching placebo tablets
10976688|NCT00941798|EG000|Reported Event|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
10976689|NCT00941798|EG001|Reported Event|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
10976690|NCT00941863|BG000|Baseline|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
10976691|NCT00941863|BG001|Baseline|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
10976692|NCT00941863|BG002|Baseline|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
10976693|NCT00941863|BG003|Baseline|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
10976694|NCT00941863|BG004|Baseline|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
10976695|NCT00941863|BG005|Baseline|Total|Total of all reporting groups
10976696|NCT00941863|FG000|Participant Flow|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
10976697|NCT00941863|FG001|Participant Flow|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
10976698|NCT00941863|FG002|Participant Flow|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
10976699|NCT00941863|FG003|Participant Flow|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
10976700|NCT00941863|FG004|Participant Flow|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
11346863|NCT04338009|BG000|Baseline|Discontinuation Arm|"The randomized intervention will be the discontinuation of ACEI/ARBs~Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion."
11346864|NCT04338009|BG001|Baseline|Continuation Arm|"The randomized intervention will be the continuation of ACEI/ARBs~Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury)."
11346865|NCT04338009|BG002|Baseline|Total|Total of all reporting groups
11346866|NCT04338009|FG000|Participant Flow|Discontinuation Arm|"The randomized intervention will be the discontinuation of ACEI/ARBs~Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion."
11346867|NCT04338009|FG001|Participant Flow|Continuation Arm|"The randomized intervention will be the continuation of ACEI/ARBs~Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury)."
11346868|NCT04338009|OG000|Outcome|Discontinuation Arm|"The randomized intervention will be the discontinuation of ACEI/ARBs~Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion."
11346869|NCT04338009|OG001|Outcome|Continuation Arm|"The randomized intervention will be the continuation of ACEI/ARBs~Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury)."
11346870|NCT04338009|EG000|Reported Event|Discontinuation Arm|"The randomized intervention will be the discontinuation of ACEI/ARBs~Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion."
11346871|NCT04338009|EG001|Reported Event|Continuation Arm|"The randomized intervention will be the continuation of ACEI/ARBs~Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury)."
10976701|NCT00941863|OG000|Outcome|Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid|All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid [twice daily], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
10976702|NCT00941863|OG000|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
10976703|NCT00941863|OG001|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
10976704|NCT00941863|OG002|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
11346872|NCT04338074|BG000|Baseline|Tranexamic Acid Treatment|Tranexamic acid tablets: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos
11346873|NCT04338074|BG001|Baseline|Placebo Treatment|Placebo oral tablet: 2 tablets p.o. three times per day x 5 days
11346874|NCT04338074|BG002|Baseline|Total|Total of all reporting groups
10848852|NCT00292045|FG000|Participant Flow|NY-ESO-1 Protein + CpG 7909|Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
10976705|NCT00941863|OG003|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
10976706|NCT00941863|OG004|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
11222987|NCT02350127|OG000|Outcome|Evaluation Group Respondents|All caregivers were sent an anonymous evaluation survey with a pre-paid return envelope upon study completion or withdrawal.
11222988|NCT02350127|EG000|Reported Event|Immediate Start|The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
11222989|NCT02350127|EG001|Reported Event|Delayed Start|Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
11222990|NCT02350309|BG000|Baseline|Placebo, Lemborexant 5 mg, Lemborexant 10 mg, Flurazepam 30 mg|Participants received a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11222991|NCT02350309|BG001|Baseline|Lemborexant 10 mg, Placebo, Lemborexant 5 mg, Flurazepam 30 mg|Participants received a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11222992|NCT02350309|BG002|Baseline|Lemborexant 5 mg, Lemborexant 10 mg, Placebo, Flurazepam 30 mg|Participants received a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11222993|NCT02350309|BG003|Baseline|Lemborexant 10 mg, Lemborexant 5 mg, Placebo, Flurazepam 30 mg|Participants received a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11222994|NCT02350309|BG004|Baseline|Lemborexant 5 mg, Placebo, Lemborexant 10 mg, Flurazepam 30 mg|Participants received a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11222995|NCT02350309|BG005|Baseline|Placebo, Lemborexant 10 mg, Lemborexant 5 mg, Flurazepam 30 mg|Participants received a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11222996|NCT02350309|BG006|Baseline|Total|Total of all reporting groups
11222997|NCT02350309|FG000|Participant Flow|Placebo, Lemborexant 5 mg, Lemborexant 10 mg, Flurazepam 30 mg|Participants received a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant 5 milligrams (mg) tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11222998|NCT02350309|FG001|Participant Flow|Lemborexant 10 mg, Placebo, Lemborexant 5 mg, Flurazepam 30 mg|Participants received a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11222999|NCT02350309|FG002|Participant Flow|Lemborexant 5 mg, Lemborexant 10 mg, Placebo, Flurazepam 30 mg|Participants received a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
11346875|NCT04338074|FG000|Participant Flow|Tranexamic Acid Treatment|Tranexamic acid tablets: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos
11346876|NCT04338074|FG001|Participant Flow|Placebo Treatment|Placebo oral tablet: 2 tablets p.o. three times per day x 5 days
11346877|NCT04338074|OG000|Outcome|Tranexamic Acid Treatment|Tranexamic acid tablets: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos
11346878|NCT04338074|OG001|Outcome|Placebo Treatment|Placebo oral tablet: 2 tablets p.o. three times per day x 5 days
11346879|NCT04338074|EG000|Reported Event|Tranexamic Acid Treatment|Tranexamic acid tablets: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos
11346880|NCT04338074|EG001|Reported Event|Placebo Treatment|Placebo oral tablet: 2 tablets p.o. three times per day x 5 days
11346881|NCT04337138|BG000|Baseline|Mylotarg|Participants with confirmed diagnosis of Acute Myeloid Leukemia (AML) on or after 01 December 2014, who received Mylotarg (Gemtuzumab ozogamicin [mean number of doses of gemtuzumab administered = 1 per participant]) from 2017 to 2020 in real-world clinical setting (i.e. treated in clinical practice and in a non-trial setting) were included in this retrospective study and their data from definitive oncology dataset was retrospectively assessed in this study of up to 4 months.
11346882|NCT04337138|FG000|Participant Flow|Mylotarg|Participants with confirmed diagnosis of Acute Myeloid Leukemia (AML) on or after 01 December 2014, who received Mylotarg (Gemtuzumab ozogamicin [mean number of doses of gemtuzumab administered = 1 per participant]) from 2017 to 2020 in real-world clinical setting (i.e. treated in clinical practice and in a non-trial setting) were included in this retrospective study and their data from definitive oncology dataset was retrospectively assessed in this study of up to 4 months.
11346883|NCT04337138|OG000|Outcome|Mylotarg|Participants with confirmed diagnosis of Acute Myeloid Leukemia (AML) on or after 01 December 2014, who received Mylotarg (Gemtuzumab ozogamicin [mean number of doses of gemtuzumab administered = 1 per participant]) from 2017 to 2020 in real-world clinical setting (i.e. treated in clinical practice and in a non-trial setting) were included in this retrospective study and their data from definitive oncology dataset was retrospectively assessed in this study of up to 4 months.
11346884|NCT04337138|EG000|Reported Event|Mylotarg|Participants with confirmed diagnosis of Acute Myeloid Leukemia (AML) on or after 01 December 2014, who received Mylotarg (Gemtuzumab ozogamicin [mean number of doses of gemtuzumab administered = 1 per participant]) from 2017 to 2020 in real-world clinical setting (i.e. treated in clinical practice and in a non-trial setting) were included in this retrospective study and their data from definitive oncology dataset was retrospectively assessed in this study of up to 4 months.
11346885|NCT04336475|BG000|Baseline|Exercise + Oral Hygiene First, Then Oral Hygiene Only|Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care. After the first month, patients continue only with daily oral hygiene care. Exercise regimen includes: 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right & left molars. 5.The subject pushes the chin to left and right sides.
11346886|NCT04336475|BG001|Baseline|Oral Hygiene Only First, Then Exercise + Oral Hygiene|Patients only perform daily oral hygiene care advices for the first month. Patients start performing exercise program in addition to oral hygiene care advices in the second month. Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds. 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right & left molars. 5.The subject pushes the chin to left and right sides.
11346887|NCT04336475|BG002|Baseline|Total|Total of all reporting groups
11346888|NCT04336475|FG000|Participant Flow|Exercise + Oral Hygiene First, Then Oral Hygiene Only|Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care. After the first month, patients continue only with daily oral hygiene care. Exercise regimen includes: 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right & left molars. 5.The subject pushes the chin to left and right sides.
11346889|NCT04336475|FG001|Participant Flow|Oral Hygiene Only First, Then Exercise + Oral Hygiene|patients only perform daily oral hygiene care advices for the first month. Patients start performing exercise program in addition to oral hygiene care advices in the second month. Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds. 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right & left molars. 5.The subject pushes the chin to left and right sides.
11346890|NCT04336475|OG000|Outcome|Exercise + Oral Hygiene First, Then Oral Hygiene Only|"st month > exercise + oral hygiene~nd month> oral hygiene only"
11346891|NCT04336475|OG001|Outcome|Oral Hygiene Only First, Then Exercise + Oral Hygiene|"st month> Oral Hygiene Only~nd month > exercise + oral hygiene"
11346892|NCT04336475|EG000|Reported Event|Exercise + Oral Hygiene|Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care.
11346893|NCT04336475|EG001|Reported Event|Oral Hygiene Only|Patients only perform daily oral hygiene care advices
11346894|NCT04335929|BG000|Baseline|Internet-based Cognitive Behavior Therapy|"The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
10848853|NCT00292045|OG000|Outcome|NY-ESO-1 Protein + CpG 7909|Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
10845441|NCT00267046|EG000|Reported Event|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
11346895|NCT04335929|FG000|Participant Flow|Internet-based Cognitive Behavior Therapy|"The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346896|NCT04335929|OG000|Outcome|Internet-based Cognitive Behavior Therapy|"The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346897|NCT04335929|EG000|Reported Event|Internet-based Cognitive Behavior Therapy|"The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346898|NCT04335812|BG000|Baseline|R-CBT|"The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346899|NCT04335812|BG001|Baseline|F-ICBT|"The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346900|NCT04335812|BG002|Baseline|Total|Total of all reporting groups
11346901|NCT04335812|FG000|Participant Flow|R-ICBT|"The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346902|NCT04335812|FG001|Participant Flow|F-ICBT|"The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346903|NCT04335812|OG000|Outcome|R-ICBT|"The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11348579|NCT04161144|BG001|Baseline|Placebo|"Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.~Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit."
11348580|NCT04161144|BG002|Baseline|Total|Total of all reporting groups
11346904|NCT04335812|OG001|Outcome|F-ICBT|"The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346905|NCT04335812|EG000|Reported Event|R-ICBT|"The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346906|NCT04335812|EG001|Reported Event|F-ICBT|"The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11346907|NCT04335136|BG000|Baseline|Group A (Active) APN01|Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID).
11346908|NCT04335136|BG001|Baseline|Group B (Placebo Control)|Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID).
11346909|NCT04335136|BG002|Baseline|Total|Total of all reporting groups
11346910|NCT04335136|FG000|Participant Flow|Group A (Active) APN01|Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID).
11346911|NCT04335136|FG001|Participant Flow|Group B (Placebo Control)|Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID).
11346912|NCT04335136|OG000|Outcome|Group A (Active) APN01|Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID).
11346913|NCT04335136|OG001|Outcome|Group B (Placebo Control)|Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID).
11346914|NCT04335136|EG000|Reported Event|Group A (Active) APN01|Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID).
11346915|NCT04335136|EG001|Reported Event|Group B (Placebo Control)|Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID).
11346916|NCT04335552|BG000|Baseline|Standard of Care|Standard of care: Standard of care
11346917|NCT04335552|BG001|Baseline|Standard of Care Plus Hydroxychloroquine|"Standard of care plus hydroxychloroquine for 5 days~Standard of care: Standard of care~Hydroxychloroquine: Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5"
11346918|NCT04335552|BG002|Baseline|Standard of Care Plus Azithromycin|"Standard of care plus azithromycin for 5 days~Standard of care: Standard of care~Azithromycin: Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5"
11346919|NCT04335552|BG003|Baseline|Standard of Care Plus Hydroxychloroquine Plus Azithromycin|"Standard of care plus hydroxychloroquine plus azithromycin for 5 days~Standard of care: Standard of care~Hydroxychloroquine: Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5~Azithromycin: Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5"
11346920|NCT04335552|BG004|Baseline|Total|Total of all reporting groups
11346921|NCT04335552|FG000|Participant Flow|Standard of Care|Standard of care: Standard of care
11346922|NCT04335552|FG001|Participant Flow|Standard of Care Plus Hydroxychloroquine|"Standard of care plus hydroxychloroquine for 5 days~Standard of care: Standard of care~Hydroxychloroquine: Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5"
11346923|NCT04335552|FG002|Participant Flow|Standard of Care Plus Azithromycin|"Standard of care plus azithromycin for 5 days~Standard of care: Standard of care~Azithromycin: Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5"
11346924|NCT04335552|FG003|Participant Flow|Standard of Care Plus Hydroxychloroquine Plus Azithromycin|"Standard of care plus hydroxychloroquine plus azithromycin for 5 days~Standard of care: Standard of care~Hydroxychloroquine: Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5~Azithromycin: Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5"
11346925|NCT04335552|OG000|Outcome|Standard of Care|Standard of care: Standard of care
11346926|NCT04335552|OG001|Outcome|Standard of Care Plus Hydroxychloroquine|"Standard of care plus hydroxychloroquine for 5 days~Standard of care: Standard of care~Hydroxychloroquine: Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5"
11346927|NCT04335552|OG002|Outcome|Standard of Care Plus Azithromycin|"Standard of care plus azithromycin for 5 days~Standard of care: Standard of care~Azithromycin: Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5"
11346928|NCT04335552|OG003|Outcome|Standard of Care Plus Hydroxychloroquine Plus Azithromycin|"Standard of care plus hydroxychloroquine plus azithromycin for 5 days~Standard of care: Standard of care~Hydroxychloroquine: Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5~Azithromycin: Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5"
11346929|NCT04335552|EG000|Reported Event|Standard of Care|Standard of care: Standard of care
11346930|NCT04335552|EG001|Reported Event|Standard of Care Plus Hydroxychloroquine|"Standard of care plus hydroxychloroquine for 5 days~Standard of care: Standard of care~Hydroxychloroquine: Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5"
11346931|NCT04335552|EG002|Reported Event|Standard of Care Plus Azithromycin|"Standard of care plus azithromycin for 5 days~Standard of care: Standard of care~Azithromycin: Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5"
11346932|NCT04335552|EG003|Reported Event|Standard of Care Plus Hydroxychloroquine Plus Azithromycin|"Standard of care plus hydroxychloroquine plus azithromycin for 5 days~Standard of care: Standard of care~Hydroxychloroquine: Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5~Azithromycin: Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5"
11346933|NCT04334876|BG000|Baseline|High Risk Healthcare Workers|"At home, finger prick, antibody test.~SARS-CoV-2 IgG Antibody Testing Kit: A, finger prick, at home test for SARS-CoV-2 IgG Antibodies."
11346934|NCT04334876|FG000|Participant Flow|High Risk Healthcare Workers|"At home, finger prick, antibody test.~SARS-CoV-2 IgG Antibody Testing Kit: A, finger prick, at home test for SARS-CoV-2 IgG Antibodies."
11346935|NCT04334876|OG000|Outcome|High Risk Healthcare Workers|"At home, finger prick, antibody test.~SARS-CoV-2 IgG Antibody Testing Kit: A, finger prick, at home test for SARS-CoV-2 IgG Antibodies."
11346936|NCT04334876|EG000|Reported Event|High Risk Healthcare Workers|"At home, finger prick, antibody test.~SARS-CoV-2 IgG Antibody Testing Kit: A, finger prick, at home test for SARS-CoV-2 IgG Antibodies."
11346937|NCT04334681|BG000|Baseline|UC Group|"Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group.~Un-roofing curettage method: In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis."
11346938|NCT04334681|BG001|Baseline|LF Group|"Patients who have been operated with the Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group.~Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the Limberg flap method."
11346939|NCT04334681|BG002|Baseline|Total|Total of all reporting groups
11346940|NCT04334681|FG000|Participant Flow|UC Group|"Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group.~Un-roofing curettage method: In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis."
11346941|NCT04334681|FG001|Participant Flow|LF Group|"Patients who have been operated with the Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group.~Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the Limberg flap method."
11346942|NCT04334681|OG000|Outcome|UC Group|"Patients operated on the un-roofing curettage method in treating the pilonidal disease will be analyzed in this group.~Un-roofing curettage method: In this method, the pilonidal cyst roof is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis."
11346943|NCT04334681|OG001|Outcome|MLF Group|"Patients who have been operated on with the modified Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group.~Modified Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method."
11346944|NCT04334681|OG000|Outcome|MLF Group|"Patients who have been operated on with the modified Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group.~Modified Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method."
11346945|NCT04334681|OG001|Outcome|UC Group|"Patients operated on the un-roofing curettage method in treating the pilonidal disease will be analyzed in this group.~Un-roofing curettage method: In this method, the pilonidal cyst roof is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis."
11346946|NCT04334681|EG000|Reported Event|UC Group|"Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group.~Un-roofing curettage method: In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis."
11346947|NCT04334681|EG001|Reported Event|LF Group|"Patients who have been operated with the Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group.~Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the Limberg flap method."
11346948|NCT04333225|BG000|Baseline|Hydroxychloroquine|Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks
11346949|NCT04333225|BG001|Baseline|Control|Subjects who declined taking HCQ were considered as controls
11346950|NCT04333225|BG002|Baseline|Total|Total of all reporting groups
11346951|NCT04333225|FG000|Participant Flow|Hydroxychloroquine|Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks
11346952|NCT04333225|FG001|Participant Flow|Control|Subjects who declined taking HCQ were considered as controls
10976707|NCT00941863|OG005|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
10976708|NCT00941863|OG000|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
10976709|NCT00941863|OG000|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
11346953|NCT04333225|OG000|Outcome|Hydroxychloroquine|Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks
11346954|NCT04333225|OG001|Outcome|Control|Subjects who declined taking HCQ were considered as controls
11346955|NCT04333225|EG000|Reported Event|Hydroxychloroquine|Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks
11346956|NCT04333225|EG001|Reported Event|Control|Subjects who declined taking HCQ were considered as controls
11348581|NCT04161144|FG000|Participant Flow|Rapamycin 15mg (Sirolimus)|"Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.~sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit."
11348582|NCT04161144|FG001|Participant Flow|Placebo|"Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.~Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit."
11348583|NCT04161144|OG000|Outcome|Rapamycin 15mg (Sirolimus)|"Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.~sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit."
11348584|NCT04161144|OG001|Outcome|Placebo|"Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.~Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit."
11348585|NCT04161144|EG000|Reported Event|Rapamycin 15mg (Sirolimus)|"Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.~sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit."
11348586|NCT04161144|EG001|Reported Event|Placebo|"Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.~Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit."
11348587|NCT04161079|BG000|Baseline|MAR Population|"Baseline data was presented for this follow-up clinical investigation 2010-040FU5 population (7 participants) which included participants who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040 and were enrolled in this follow-up clinical investigation 2010-040FU5.~Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040."
11348588|NCT04161079|FG000|Participant Flow|MAR Population|"Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040~Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040~For some of outcome measures it is defined as MAR Population >5 Years Follow-up Timepoint"
11348589|NCT04161079|OG000|Outcome|MAR Population|"2010-040FU5 >5 years follow-up population~Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040~Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040"
11346957|NCT04333199|BG000|Baseline|Control|Patients do not receive an email
11346958|NCT04333199|BG001|Baseline|Timely Nudge - View Results|"Patients are emailed about myGeisinger when they have a lab result ready to view. The email includes a View My Lab Results button, which encourages them to click as a pre-commitment step that then brings them to the myGeisinger sign-up page.~Timely: Email~Foot-in-the-door: Email"
11346959|NCT04333199|BG002|Baseline|Timely Nudge - Get Started|"Patients are emailed about myGeisinger when they have a lab result ready to view. The email includes a Get Started With myGeisinger button that is transparent about the next step in the process, before the patient can view test results.~Timely: Email~Transparency: Email"
11346960|NCT04333199|BG003|Baseline|Total|Total of all reporting groups
11346961|NCT04333199|FG000|Participant Flow|Control|Patients do not receive an email
11346962|NCT04333199|FG001|Participant Flow|Timely Nudge - View Results|"Patients are emailed about myGeisinger when they have a lab result ready to view. The email includes a View My Lab Results button, which encourages them to click as a pre-commitment step that then brings them to the myGeisinger sign-up page.~Timely: Email~Foot-in-the-door: Email"
11346963|NCT04333199|FG002|Participant Flow|Timely Nudge - Get Started|"Patients are emailed about myGeisinger when they have a lab result ready to view. The email includes a Get Started With myGeisinger button that is transparent about the next step in the process, before the patient can view test results.~Timely: Email~Transparency: Email"
11346964|NCT04333199|OG000|Outcome|Control|Patients do not receive an email
11346965|NCT04333199|OG001|Outcome|Timely Nudge|"Patients are emailed about myGeisinger when they have a lab result ready to view.~Timely: Email"
11346966|NCT04333199|OG000|Outcome|Timely Nudge - View Results|"Patients are emailed about myGeisinger when they have a lab result ready to view. The email includes a View My Lab Results button, which encourages them to click as a pre-commitment step that then brings them to the myGeisinger sign-up page.~Timely: Email~Foot-in-the-door: Email"
11346967|NCT04333199|OG001|Outcome|Timely Nudge - Get Started|"Patients are emailed about myGeisinger when they have a lab result ready to view. The email includes a Get Started With myGeisinger button that is transparent about the next step in the process, before the patient can view test results.~Timely: Email~Transparency: Email"
11346968|NCT04333199|EG000|Reported Event|Control|Patients do not receive an email
11346969|NCT04333199|EG001|Reported Event|Timely Nudge - View Results|"Patients are emailed about myGeisinger when they have a lab result ready to view. The email includes a View My Lab Results button, which encourages them to click as a pre-commitment step that then brings them to the myGeisinger sign-up page.~Timely: Email~Foot-in-the-door: Email"
11346970|NCT04333199|EG002|Reported Event|Timely Nudge - Get Started|"Patients are emailed about myGeisinger when they have a lab result ready to view. The email includes a Get Started With myGeisinger button that is transparent about the next step in the process, before the patient can view test results.~Timely: Email~Transparency: Email"
11346971|NCT04332991|BG000|Baseline|Hydroxychloroquine|"Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.~Hydroxychloroquine: Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.~For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course."
11346972|NCT04332991|BG001|Baseline|Placebo|"Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.~Placebo: Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding."
11346973|NCT04332991|BG002|Baseline|Total|Total of all reporting groups
11346974|NCT04332991|FG000|Participant Flow|Hydroxychloroquine|"Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.~Hydroxychloroquine: Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.~For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course."
11346975|NCT04332991|FG001|Participant Flow|Placebo|"Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.~Placebo: Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding."
11346976|NCT04332991|OG000|Outcome|Hydroxychloroquine|"Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.~Hydroxychloroquine: Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.~For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course."
11346977|NCT04332991|OG001|Outcome|Placebo|"Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.~Placebo: Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding."
11348590|NCT04161079|OG000|Outcome|Clinical Investigation 2010-040 2-year Follow-up|Data for MAR population during clinical Investigation 2010-040, collected 2 years after MAR implantation
11348591|NCT04161079|OG001|Outcome|2010-040FU5 >5 Years Follow-up|"Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040~Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040"
10976710|NCT00941863|EG000|Reported Event|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
11346978|NCT04332991|EG000|Reported Event|Hydroxychlorquine|"Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.~Hydroxychloroquine: Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.~For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course."
11346979|NCT04332991|EG001|Reported Event|Placebo|"Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.~Placebo: Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding."
11346980|NCT04332614|BG000|Baseline|Control|"A standard marketing message encouraging activation and describing the benefits of myGeisinger~Standard email: Email"
11346981|NCT04332614|BG001|Baseline|Focused on Provider Communication|"A simple message focused on one benefit of myGeisinger: communicating easily with providers~Less-is-better: Email"
11346982|NCT04332614|BG002|Baseline|Focused on Scheduling|"A simple message focused on one benefit of myGeisinger: scheduling and managing appointments online~Less-is-better: Email"
11346983|NCT04332614|BG003|Baseline|Focused on Medical Information Access|"A simple message focused on one benefit of myGeisinger: accessing medical information, like test results~Less-is-better: Email"
11346984|NCT04332614|BG004|Baseline|Social Proof|"A message similar to control, but including information about how many other patients are using myGeisinger~Social proof: Email"
11346985|NCT04332614|BG005|Baseline|Endowment / Decision Staging|"A message similar to control, but framing myGeisinger as something that patients already have, and just need to take one more step to activate.~Endowment: Give patients the impression they already have the account, so they value it more.~Decision staging: Break down the process into multiple stages - having an account and activating that account- and giving the impression that they are almost there because the first stage is complete~Endowment / decision staging: Email"
11346986|NCT04332614|BG006|Baseline|Total|Total of all reporting groups
10976711|NCT00941863|EG001|Reported Event|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
10976712|NCT00941863|EG002|Reported Event|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
10976713|NCT00941863|EG003|Reported Event|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
10976714|NCT00941863|EG004|Reported Event|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
10976715|NCT00941889|BG000|Baseline|Placebo|Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.
10976716|NCT00941889|BG001|Baseline|Gardasil|Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.
11346987|NCT04332614|FG000|Participant Flow|Control|"A standard marketing message encouraging activation and describing the benefits of myGeisinger~Standard email: Email"
11346988|NCT04332614|FG001|Participant Flow|Focused on Provider Communication|"A simple message focused on one benefit of myGeisinger: communicating easily with providers~Less-is-better: Email"
10976717|NCT00941889|BG002|Baseline|Total|Total of all reporting groups
10976718|NCT00941889|FG000|Participant Flow|Placebo|Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.
10976719|NCT00941889|FG001|Participant Flow|Gardasil Group|The treatment group will receive a 0.5 mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
10976720|NCT00941889|OG000|Outcome|Placebo Group|Patients who received placebo of saline at initial visit, 2 months and 6 months after enrollment.
10976721|NCT00941889|OG001|Outcome|Gardasil Group|Patients who received Gardasil injection at initial visit, 2 months, and 6 months after enrollment.
10976722|NCT00941889|EG000|Reported Event|Placebo|Patients who are in the control group received a placebo of saline at initial date, 2 months and 6 months.
10976723|NCT00941889|EG001|Reported Event|Treatment Group|The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
10976724|NCT00941993|BG000|Baseline|Iontophoretic Delivery of Anesthesia|"Tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
11346989|NCT04332614|FG002|Participant Flow|Focused on Scheduling|"A simple message focused on one benefit of myGeisinger: scheduling and managing appointments online~Less-is-better: Email"
11346990|NCT04332614|FG003|Participant Flow|Focused on Medical Information Access|"A simple message focused on one benefit of myGeisinger: accessing medical information, like test results~Less-is-better: Email"
11346991|NCT04332614|FG004|Participant Flow|Social Proof|"A message similar to control, but including information about how many other patients are using myGeisinger~Social proof: Email"
11346992|NCT04332614|FG005|Participant Flow|Endowment / Decision Staging|"A message similar to control, but framing myGeisinger as something that patients already have, and just need to take one more step to activate.~Endowment: Give patients the impression they already have the account, so they value it more.~Decision staging: Break down the process into multiple stages - having an account and activating that account- and giving the impression that they are almost there because the first stage is complete~Endowment / decision staging: Email"
11346993|NCT04332614|OG000|Outcome|Control|A standard marketing message encouraging activation and describing the benefits of myGeisinger
10976725|NCT00941993|FG000|Participant Flow|Iontophoretic Delivery of Local Anesthesia|"Tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
10976726|NCT00941993|OG000|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
10976727|NCT00941993|OG000|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
11346994|NCT04332614|OG001|Outcome|Less-is-better|A simple message focused on one benefit of myGeisinger.
11346995|NCT04332614|OG002|Outcome|Social Proof|A message similar to control, but including information about how many other patients are using myGeisinger
11346996|NCT04332614|OG003|Outcome|Endowment / Decision Staging|"A message similar to control, but framing myGeisinger as something that patients already have, and just need to take one more step to activate.~Endowment: Give patients the impression they already have the account, so they value it more.~Decision staging: Break down the process into multiple stages - having an account and activating that account- and giving the impression that they are almost there because the first stage is complete"
11346997|NCT04332614|OG000|Outcome|Focused on Provider Communication|"A simple message focused on one benefit of myGeisinger: communicating easily with providers~Less-is-better: Email"
11346998|NCT04332614|OG001|Outcome|Focused on Scheduling|"A simple message focused on one benefit of myGeisinger: scheduling and managing appointments online~Less-is-better: Email"
11346999|NCT04332614|OG002|Outcome|Focused on Medical Information Access|"A simple message focused on one benefit of myGeisinger: accessing medical information, like test results~Less-is-better: Email"
11347000|NCT04332614|EG000|Reported Event|Control|"A standard marketing message encouraging activation and describing the benefits of myGeisinger~Standard email: Email"
11347001|NCT04332614|EG001|Reported Event|Focused on Provider Communication|"A simple message focused on one benefit of myGeisinger: communicating easily with providers~Less-is-better: Email"
11347002|NCT04332614|EG002|Reported Event|Focused on Scheduling|"A simple message focused on one benefit of myGeisinger: scheduling and managing appointments online~Less-is-better: Email"
11347003|NCT04332614|EG003|Reported Event|Focused on Medical Information Access|"A simple message focused on one benefit of myGeisinger: accessing medical information, like test results~Less-is-better: Email"
11347004|NCT04332614|EG004|Reported Event|Social Proof|"A message similar to control, but including information about how many other patients are using myGeisinger~Social proof: Email"
11347005|NCT04332614|EG005|Reported Event|Endowment / Decision Staging|"A message similar to control, but framing myGeisinger as something that patients already have, and just need to take one more step to activate.~Endowment: Give patients the impression they already have the account, so they value it more.~Decision staging: Break down the process into multiple stages - having an account and activating that account- and giving the impression that they are almost there because the first stage is complete~Endowment / decision staging: Email"
11347006|NCT04322968|BG000|Baseline|Chronic Pain With PTSD+IV Ketamine Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347007|NCT04322968|BG001|Baseline|Chronic Pain With PTSD+IV Ketorolac Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347008|NCT04322968|BG002|Baseline|Chronic Pain Without PTSD+IV Ketamine Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347009|NCT04322968|BG003|Baseline|Chronic Pain Without PTSD+IV Ketorolac Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347010|NCT04322968|BG004|Baseline|Total|Total of all reporting groups
11347011|NCT04322968|FG000|Participant Flow|Chronic Pain With PTSD+IV Ketamine Infusion|A single low dose iv ketamine infusion (0.5 mg/kg) administered over 40 min.
11347012|NCT04322968|FG001|Participant Flow|Chronic Pain With PTSD+IV Ketorolac Infusion|A single iv infusion of ketorolac (15 mg) administered over 40 min.
11347013|NCT04322968|FG002|Participant Flow|Chronic Pain Without PTSD+IV Ketamine Infusion|A single low dose iv ketamine infusion (0.5 mg/kg) administered over 40 min.
11347014|NCT04322968|FG003|Participant Flow|Chronic Pain Without PTSD+IV Ketorolac Infusion|A single iv infusion of ketorolac (15 mg) administered over 40 min.
11347015|NCT04322968|OG000|Outcome|Chronic Pain With PTSD+IV Ketamine Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11348592|NCT04161079|OG000|Outcome|MAR Population|"Clinical investigation 2010-040 2-year follow-up population~Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040~Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040"
10855621|NCT00330187|BG000|Baseline|Bupropion SR + Contingency Management|"Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.~Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment~Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence."
10855622|NCT00330187|BG001|Baseline|Placebo + Contingency Management|"Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.~Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.~Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment"
10855623|NCT00330187|BG002|Baseline|Bupropion SR + No Contingency Management|"Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.~Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment"
10855624|NCT00330187|BG003|Baseline|Placebo + No Contingency Management|"Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.~Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment"
10855625|NCT00330187|BG004|Baseline|Total|Total of all reporting groups
10855626|NCT00330187|FG000|Participant Flow|Bupropion SR + Contingency Management|"Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.~Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment~Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence."
10855627|NCT00330187|FG001|Participant Flow|Placebo + Contingency Management|"Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.~Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.~Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment"
10855628|NCT00330187|FG002|Participant Flow|Bupropion SR + No Contingency Management|"Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.~Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment"
10855629|NCT00330187|FG003|Participant Flow|Placebo + No Contingency Management|"Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.~Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment"
10855630|NCT00330187|OG000|Outcome|Bupropion SR + Contingency Management|"Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.~Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment~Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence."
10855631|NCT00330187|OG001|Outcome|Placebo + Contingency Management|"Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.~Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.~Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment"
10855632|NCT00330187|OG002|Outcome|Bupropion SR + No Contingency Management|"Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.~Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment"
10855633|NCT00330187|OG003|Outcome|Placebo + No Contingency Management|"Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.~Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment"
10855634|NCT00330187|EG000|Reported Event|Bupropion SR + Contingency Management|"Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.~Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment~Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence."
10855635|NCT00330187|EG001|Reported Event|Placebo + Contingency Management|"Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.~Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.~Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment"
10855636|NCT00330187|EG002|Reported Event|Bupropion SR + No Contingency Management|"Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.~Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment"
10855637|NCT00330187|EG003|Reported Event|Placebo + No Contingency Management|"Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.~Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment"
10855638|NCT00330343|BG000|Baseline|Group 1|
10855639|NCT00330343|FG000|Participant Flow|Naloxone|
10855640|NCT00330343|OG000|Outcome|Naloxone|
10855641|NCT00330343|EG000|Reported Event|Group 1|
10855642|NCT00330382|BG000|Baseline|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
11347016|NCT04322968|OG001|Outcome|Chronic Pain With PTSD+IV Ketorolac Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347017|NCT04322968|OG002|Outcome|Chronic Pain Without PTSD+IV Ketamine Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347018|NCT04322968|OG003|Outcome|Chronic Pain Without PTSD+IV Ketorolac Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347019|NCT04322968|EG000|Reported Event|Chronic Pain With PTSD+IV Ketamine Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347020|NCT04322968|EG001|Reported Event|Chronic Pain With PTSD+IV Ketorolac Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347021|NCT04322968|EG002|Reported Event|Chronic Pain Without PTSD+IV Ketamine Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347022|NCT04322968|EG003|Reported Event|Chronic Pain Without PTSD+IV Ketorolac Infusion|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
11347023|NCT04332081|BG000|Baseline|Hyperbaric Oxygen Therapy (HBOT)|hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.
11347024|NCT04332081|BG001|Baseline|Standard of Care|No HBOT
11347025|NCT04332081|BG002|Baseline|Total|Total of all reporting groups
11347026|NCT04332081|FG000|Participant Flow|Hyperbaric Oxygen Therapy (HBOT)|hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.
11347027|NCT04332081|FG001|Participant Flow|Standard of Care|No HBOT
11347028|NCT04332081|OG000|Outcome|Hyperbaric Oxygen Therapy (HBOT)|hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.
11347029|NCT04332081|OG001|Outcome|Standard of Care|No HBOT
11347030|NCT04332081|EG000|Reported Event|Hyperbaric Oxygen Therapy (HBOT)|hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.
11347031|NCT04332081|EG001|Reported Event|Standard of Care|No HBOT
11347032|NCT04332107|BG000|Baseline|Azithromycin|"1.2g of oral azithromycin~Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin"
11347033|NCT04332107|BG001|Baseline|Placebo|"Matching placebo~Placebos: Participants will be shipped a dose of matching placebo"
11347034|NCT04332107|BG002|Baseline|Total|Total of all reporting groups
11347035|NCT04332107|FG000|Participant Flow|Azithromycin|"1.2g of oral azithromycin~Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin"
11347036|NCT04332107|FG001|Participant Flow|Placebo|"Matching placebo~Placebos: Participants will be shipped a dose of matching placebo"
11347037|NCT04332107|OG000|Outcome|Azithromycin|"1.2g of oral azithromycin~Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin"
11347038|NCT04332107|OG001|Outcome|Placebo|"Matching placebo~Placebos: Participants will be shipped a dose of matching placebo"
11347039|NCT04332107|EG000|Reported Event|Azithromycin|"1.2g of oral azithromycin~Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin"
11347040|NCT04332107|EG001|Reported Event|Placebo|"Matching placebo~Placebos: Participants will be shipped a dose of matching placebo"
11348593|NCT04161079|EG000|Reported Event|Clinical Investigation 2010-040 2-year Follow-up|"Data for MAR population during clinical Investigation 2010-040, 11 participants, collected for the time frame since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure (2010-040FU5)~Serious adverse events and other adverse events data collected only for study 2010-040FU5 participants"
11347041|NCT04323592|BG000|Baseline|Exposed to Methylprednisolone|"SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at low prolonged dose.~At admission, inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering until normal CRP values (+20%) are reached.~Methylprednisolone: Methylprednisolone given at low prolonged dose infusion after initial 80mg iv bolus at admission followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description~standard care: usual standard of care:~oxygen therapy (regular or high-flow) and monitoring~empiric antibiotic therapy~mechanical ventilation (invasive or noninvasive)~ECMO when needed and available~pronati"
11347042|NCT04323592|BG001|Baseline|Non-exposed to Methylprednisolone|"Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:~CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control.~standard care: usual standard of care:~oxygen therapy (regular or high-flow) and monitoring~empiric antibiotic therapy~mechanical ventilation (invasive or noninvasive)~ECMO when needed and available~pronation when possible~other treatment which can be used are: antivirals, chloroquine, vitamins"
11347043|NCT04323592|BG002|Baseline|Total|Total of all reporting groups
11347044|NCT04323592|FG000|Participant Flow|Exposed to Methylprednisolone|"SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.~Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.~Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description~standard care: usual standard of care:~respiratory support~empiric antibiotic therapy~mechanical ventilation (invasive or noninvasive)~pronation when possible~other treatment which can be used are: antivirals, chloroquine, vitamins"
11347045|NCT04323592|FG001|Participant Flow|Non-exposed to Methylprednisolone|"Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:~CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control.~standard care: usual standard of care:~respiratory support~empiric antibiotic therapy~mechanical ventilation (invasive or noninvasive)pronation when possible~other treatment which can be used are: antivirals, chloroquine, vitamins"
11347046|NCT04323592|OG000|Outcome|Exposed to Methylprednisolone|"SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.~Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.~Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description~standard care: usual standard of care:~respiratory support~empiric antibiotic therapy~mechanical ventilation (invasive or noninvasive)~pronation when possible~other treatment which can be used are: antivirals, chloroquine, vitamins"
11347047|NCT04323592|OG001|Outcome|Non-exposed to Methylprednisolone|"Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:~CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control.~standard care: usual standard of care:~respiratory support~empiric antibiotic therapy~mechanical ventilation (invasive or noninvasive)pronation when possible~other treatment which can be used are: antivirals, chloroquine, vitamins"
11347048|NCT04323592|EG000|Reported Event|Exposed to Methylprednisolone|"SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.~Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.~Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description~standard care: usual standard of care:~respiratory support~empiric antibiotic therapy~mechanical ventilation (invasive or noninvasive)~pronation when possible~other treatment which can be used are: antivirals, chloroquine, vitamins"
11347049|NCT04323592|EG001|Reported Event|Non-exposed to Methylprednisolone|"Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters:~CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control.~standard care: usual standard of care:~respiratory support~empiric antibiotic therapy~mechanical ventilation (invasive or noninvasive)pronation when possible~other treatment which can be used are: antivirals, chloroquine, vitamins"
11348594|NCT04161079|EG001|Reported Event|2010-040FU5 >5 Years Follow-up|"Patient, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040 and were enrolled in clinical investigation 2010-040FU5~Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040"
11347050|NCT04326842|BG000|Baseline|Carotid Artery Stenosis|"Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure~Carotid artery revascularization procedure: The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.~Optical coherence tomography angiography: Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps."
11347051|NCT04326842|BG001|Baseline|Control|"Patients without carotid artery stenosis~Optical coherence tomography angiography: Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps."
11347052|NCT04326842|BG002|Baseline|Total|Total of all reporting groups
11347053|NCT04326842|FG000|Participant Flow|Carotid Artery Stenosis|"Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure~Carotid artery revascularization procedure: The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.~Optical coherence tomography angiography: Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps."
11347054|NCT04326842|FG001|Participant Flow|Control|"Patients without carotid artery stenosis~Optical coherence tomography angiography: Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps."
11347055|NCT04326842|OG000|Outcome|Carotid Artery Stenosis|"Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure~Carotid artery revascularization procedure: The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.~Optical coherence tomography angiography: Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps."
11347056|NCT04326842|OG001|Outcome|Control|"Patients without carotid artery stenosis~Optical coherence tomography angiography: Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps."
11347057|NCT04326842|EG000|Reported Event|Carotid Artery Stenosis|"Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure~Carotid artery revascularization procedure: The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.~Optical coherence tomography angiography: Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps."
11347058|NCT04326842|EG001|Reported Event|Control|Patients without carotid artery stenosis. Examination will be performed using optical coherence tomography angiography. Control group did not undergo carotid artery surgery.
11347059|NCT04325542|BG000|Baseline|HBSAG Positive With Rapid Test|"Newborns from woman who are positive with HBSAG rapid test got WHO recommended HBV vaccination at birth to avoid HBV transmission~HBSAg (sure screen test): Diagnostic test for Hepatitis B"
11347060|NCT04325542|FG000|Participant Flow|HBSAG Positive With Rapid Test|"Newborns from woman who are positive with HBSAG rapid test got WHO recommended HBV vaccination at birth to avoid HBV transmission~HBSAg (sure screen test): Diagnostic test for Hepatitis B"
11347061|NCT04325542|OG000|Outcome|HBSAG Positive With Rapid Test|"Number of women attending antenatal clinic at the Bugando Medical Center in Mwanza, Tanzania with Hepatitis B surface antigen (HBsAg) rapid test positive result.~HBSAg (sure screen test): Diagnostic test for Hepatitis B"
11347062|NCT04325542|EG000|Reported Event|HBSAG Positive With Rapid Test|"Number of women attending antenatal clinic at the Bugando Medical Center in Mwanza, Tanzania with Hepatitis B surface antigen (HBsAg) rapid test positive result.~HBSAg (sure screen test): Diagnostic test for Hepatitis B"
11347063|NCT04329923|BG000|Baseline|Cohort 1 HCQ|"COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days~Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound"
11347064|NCT04329923|BG001|Baseline|Cohort 1 Placebo|"COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment.~Placebo oral tablet: Placebo"
10976728|NCT00941993|EG000|Reported Event|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
10976729|NCT00942084|BG000|Baseline|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
10976730|NCT00942084|FG000|Participant Flow|Acyclovir Study Enrollment|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
11347065|NCT04329923|BG002|Baseline|Cohort 2 HCQ High Dose|"Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days~Hydroxychloroquine Sulfate 600 mg twice a day: Antimalarial compound"
11347066|NCT04329923|BG003|Baseline|Cohort 2 HCQ Low Dose|"Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days~Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound"
11347067|NCT04329923|BG004|Baseline|Cohort 3 HCQ|"Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months~Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound"
11347068|NCT04329923|BG005|Baseline|Cohort 3 Placebo|"Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive.~Placebo oral tablet: Placebo"
11347069|NCT04329923|BG006|Baseline|Total|Total of all reporting groups
11347070|NCT04329923|FG000|Participant Flow|Cohort 1 HCQ|"COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days~Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound"
11347071|NCT04329923|FG001|Participant Flow|Cohort 1 Placebo|"COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment.~Placebo oral tablet: Placebo"
11347072|NCT04329923|FG002|Participant Flow|Cohort 2 HCQ High Dose|"Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days~Hydroxychloroquine Sulfate 600 mg twice a day: Antimalarial compound"
11347073|NCT04329923|FG003|Participant Flow|Cohort 2 HCQ Low Dose|"Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days~Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound"
11347074|NCT04329923|FG004|Participant Flow|Cohort 3 HCQ|"Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months~Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound"
11347075|NCT04329923|FG005|Participant Flow|Cohort 3 Placebo|"Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive.~Placebo oral tablet: Placebo"
11347076|NCT04329923|OG000|Outcome|Cohort 1 HCQ|"COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days~Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound"
11347077|NCT04329923|OG001|Outcome|Cohort 1 Placebo|"COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment.~Placebo oral tablet: Placebo"
11347078|NCT04329923|OG000|Outcome|Cohort 2 HCQ High Dose|"Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days~Hydroxychloroquine Sulfate 600 mg twice a day: Antimalarial compound"
11347079|NCT04329923|OG001|Outcome|Cohort 2 HCQ Low Dose|"Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days~Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound"
11347080|NCT04329923|OG000|Outcome|Cohort 3 HCQ|"Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months~Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound"
11347081|NCT04329923|OG001|Outcome|Cohort 3 Placebo|"Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive.~Placebo oral tablet: Placebo"
11347082|NCT04329923|EG000|Reported Event|Cohort 1 HCQ|"COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days~Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound"
11347083|NCT04329923|EG001|Reported Event|Cohort 1 Placebo|"COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment.~Placebo oral tablet: Placebo"
11347084|NCT04329923|EG002|Reported Event|Cohort 2 HCQ High Dose|"Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days~Hydroxychloroquine Sulfate 600 mg twice a day: Antimalarial compound"
11347085|NCT04329923|EG003|Reported Event|Cohort 2 HCQ Low Dose|"Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days~Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound"
11347086|NCT04329923|EG004|Reported Event|Cohort 3 HCQ|"Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months~Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound"
11347087|NCT04329923|EG005|Reported Event|Cohort 3 Placebo|"Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive.~Placebo oral tablet: Placebo"
11347088|NCT04328467|BG000|Baseline|Intervention Once Weekly|"400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks~Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral"
11347089|NCT04328467|BG001|Baseline|Intervention Twice Weekly|"400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks~Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral"
11347090|NCT04328467|BG002|Baseline|Control Group|"Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks~Placebo: Placebo; tablet; oral"
11347091|NCT04328467|BG003|Baseline|Total|Total of all reporting groups
11347092|NCT04328467|FG000|Participant Flow|Intervention Once Weekly|"400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks~Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral"
11347093|NCT04328467|FG001|Participant Flow|Intervention Twice Weekly|"400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks~Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral"
11347094|NCT04328467|FG002|Participant Flow|Control Group|"Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks~Placebo: Placebo; tablet; oral"
11347095|NCT04328467|OG000|Outcome|Intervention Once Weekly|"400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks~Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral"
10855643|NCT00330382|BG001|Baseline|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10855644|NCT00330382|BG002|Baseline|Total|Total of all reporting groups
10855645|NCT00330382|FG000|Participant Flow|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
10855646|NCT00330382|FG001|Participant Flow|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
11347096|NCT04328467|OG001|Outcome|Intervention Twice Weekly|"400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks~Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral"
11347097|NCT04328467|OG002|Outcome|Control Group|"Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks~Placebo: Placebo; tablet; oral"
11347098|NCT04328467|EG000|Reported Event|Intervention Once Weekly|"400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks~Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral"
11347099|NCT04328467|EG001|Reported Event|Intervention Twice Weekly|"400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks~Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral"
11347100|NCT04328467|EG002|Reported Event|Control Group|"Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks~Placebo: Placebo; tablet; oral"
11347101|NCT04322526|BG000|Baseline|Naltrexone, Then Placebo|"In the naltrexone and then placebo arm, participants receive one-dose naltrexone 50mg one hour before a first fMRI scanning session on visit 1 followed by a one-dose placebo pill one hour before a second fMRI scanning session on visit 2.~Naltrexone 50 Mg Oral Tablet: Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: ~1 hour; duration: ~24 hours).~Placebo oral tablet: Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet."
11347102|NCT04322526|BG001|Baseline|Placebo, Then Naltrexone|"In the placebo and then naltrexone arm, participants receive one-dose of placebo pill one hour before a first fMRI scanning session on visit 1 followed by a one-dose naltrexone 50mg one hour before a second fMRI scanning session on visit 2.~Naltrexone 50 Mg Oral Tablet: Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: ~1 hour; duration: ~24 hours).~Placebo oral tablet: Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet."
11347103|NCT04322526|BG002|Baseline|Total|Total of all reporting groups
11347104|NCT04322526|FG000|Participant Flow|Naltrexone, Then Placebo|"In the naltrexone and then placebo arm, participants receive one-dose naltrexone 50mg one hour before a first fMRI scanning session on visit 1 followed by a one-dose placebo pill one hour before a second fMRI scanning session on visit 2.~Naltrexone 50 Mg Oral Tablet: Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: ~1 hour; duration: ~24 hours).~Placebo oral tablet: Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet."
11347105|NCT04322526|FG001|Participant Flow|Placebo, Then Naltrexone|"In the placebo and then naltrexone arm, participants receive one-dose of placebo pill one hour before a first fMRI scanning session on visit 1 followed by a one-dose naltrexone 50mg one hour before a second fMRI scanning session on visit 2.~Naltrexone 50 Mg Oral Tablet: Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: ~1 hour; duration: ~24 hours).~Placebo oral tablet: Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet."
10855647|NCT00330382|OG000|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
10855648|NCT00330382|OG001|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10855649|NCT00330382|OG000|Outcome|Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups|"Patients receive oral Bowman-Birk inhibitor concentrate or Placebo twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally Placebo: Given orally laboratory biomarker analysis: Correlative studies"
10855650|NCT00330382|EG000|Reported Event|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
10855651|NCT00330382|EG001|Reported Event|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10855652|NCT00330421|BG000|Baseline|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
10855653|NCT00330421|FG000|Participant Flow|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
11347106|NCT04322526|OG000|Outcome|fMRI BOLD Responses in the rACC Cortex (Placebo Session)|"We examined baseline brain measures of contextual processing during the placebo session only. In particular, we obtained whole-brain BOLD fMRI responses during the processing of contextual cues and extracted BOLD signal measures in the rACC.~Post-naltrexone brain responses were not used for this analysis."
11347107|NCT04322526|OG000|Outcome|fMRI BOLD Responses in the rACC Cortex (Naltrexone vs Placebo)|We examined naltrexone-induced changes in brain signal during the processing of contextual cues by extracting brain responses in the rACC and comparing then during the baseline (placebo only) and the naltrexone session using paired-t test statistical analysis.
11347108|NCT04322526|EG000|Reported Event|Placebo|Placebo oral tablet: Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet.
11347109|NCT04322526|EG001|Reported Event|Naltrexone|Naltrexone 50 Mg Oral Tablet: Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: ~1 hour; duration: ~24 hours).
11347110|NCT04322500|BG000|Baseline|Group A: Conservative|"conservative treatment~conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days"
11347111|NCT04322500|BG001|Baseline|Group B: Probiotics|"in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01)~probiotics: use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis~conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days"
11347112|NCT04322500|BG002|Baseline|Total|Total of all reporting groups
11347113|NCT04322500|FG000|Participant Flow|Group A: Conservative|"conservative treatment~conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days"
11347114|NCT04322500|FG001|Participant Flow|Group B: Probiotics|"in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01)~probiotics: use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis~conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days"
11347115|NCT04322500|OG000|Outcome|Group A: Conservative|"conservative treatment~conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days"
11347116|NCT04322500|OG001|Outcome|Group B: Probiotics|"in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01)~probiotics: use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis~conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days"
11347117|NCT04322500|EG000|Reported Event|Group A: Conservative|"conservative treatment~conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days"
11347118|NCT04322500|EG001|Reported Event|Group B: Probiotics|"in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01)~probiotics: use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis~conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days"
11347119|NCT04322682|BG000|Baseline|Colchicine|Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
11347120|NCT04322682|BG001|Baseline|Placebo|Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
11347121|NCT04322682|BG002|Baseline|Total|Total of all reporting groups
11347122|NCT04322682|FG000|Participant Flow|Colchicine|Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
11347123|NCT04322682|FG001|Participant Flow|Placebo|Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
11347124|NCT04322682|OG000|Outcome|Colchicine|Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
11347125|NCT04322682|OG001|Outcome|Placebo|Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
11347126|NCT04322682|EG000|Reported Event|Colchicine|Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
11347127|NCT04322682|EG001|Reported Event|Placebo|Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
11347128|NCT04321980|BG000|Baseline|Cohort 1: 4 mg/kg|Participants in Cohort 1 received a single dose of 4 milligram per kg (mg/kg) OP-101 as subcutaneous (SC) injection on Day 1.
11347129|NCT04321980|BG001|Baseline|Cohort 2: 8 mg/kg|Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
11347130|NCT04321980|BG002|Baseline|Total|Total of all reporting groups
11347131|NCT04321980|FG000|Participant Flow|Cohort 1: 4 mg/kg|Participants in Cohort 1 received a single dose of 4 milligram per kg (mg/kg) OP-101 as subcutaneous (SC) injection on Day 1.
11347132|NCT04321980|FG001|Participant Flow|Cohort 2: 8 mg/kg|Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
11347133|NCT04321980|OG000|Outcome|Cohort 1: 4 mg/kg|Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1.
11347134|NCT04321980|OG001|Outcome|Cohort 2: 8 mg/kg|Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
11347135|NCT04321980|EG000|Reported Event|Cohort 1: 4 mg/kg|Participants in Cohort 1 received a single dose of 4 mg/kg OP-101 as SC injection on Day 1.
11347136|NCT04321980|EG001|Reported Event|Cohort 2: 8 mg/kg|Participants in Cohort 2 received a single dose of 8 mg/kg OP-101 as SC injection on Day 1.
11347137|NCT04322396|BG000|Baseline|Control|"This arm will receive standard care and placebo in 15 days.~Placebo oral tablet: Placebo Azithromycin~Placebo oral tablet: Placebo Hydroxychloroquine"
11347138|NCT04322396|BG001|Baseline|Intervention|"This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.~Azithromycin: Azithromycin~Hydroxychloroquine: Hydroxychloroquine"
11347139|NCT04322396|BG002|Baseline|Total|Total of all reporting groups
11347140|NCT04322396|FG000|Participant Flow|Control|"This arm will receive standard care and placebo in 15 days.~Placebo oral tablet: Placebo Azithromycin~Placebo oral tablet: Placebo Hydroxychloroquine"
11347141|NCT04322396|FG001|Participant Flow|Intervention|"This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.~Azithromycin: Azithromycin~Hydroxychloroquine: Hydroxychloroquine"
11347142|NCT04322396|OG000|Outcome|Control|"This arm will receive standard care and placebo in 15 days.~Placebo oral tablet: Placebo Azithromycin~Placebo oral tablet: Placebo Hydroxychloroquine"
10976731|NCT00942084|OG000|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
11347143|NCT04322396|OG001|Outcome|Intervention|"This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.~Azithromycin: Azithromycin~Hydroxychloroquine: Hydroxychloroquine"
11347144|NCT04322396|EG000|Reported Event|Control|"This arm will receive standard care and placebo in 15 days.~Placebo oral tablet: Placebo Azithromycin~Placebo oral tablet: Placebo Hydroxychloroquine"
11347145|NCT04322396|EG001|Reported Event|Intervention|"This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.~Azithromycin: Azithromycin~Hydroxychloroquine: Hydroxychloroquine"
11347146|NCT04320823|BG000|Baseline|Experimental Group|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347147|NCT04320823|BG001|Baseline|Control Group|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347148|NCT04320823|BG002|Baseline|Total|Total of all reporting groups
11347149|NCT04320823|FG000|Participant Flow|Experimental Group|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347150|NCT04320823|FG001|Participant Flow|Control Group|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347151|NCT04320823|OG000|Outcome|Experimental Group|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347152|NCT04320823|OG001|Outcome|Control Group|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347153|NCT04320823|OG000|Outcome|Experimental Group With Weight ≤ 130 Lbs|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347154|NCT04320823|OG001|Outcome|Control Group With Weight ≤ 130 Lbs|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347155|NCT04320823|OG002|Outcome|Experimental Group With Weight > 130 Lbs|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347156|NCT04320823|OG003|Outcome|Control Group With Weight > 130 Lbs|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347157|NCT04320823|OG000|Outcome|Experimental Group With BMI ≤ 30|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347158|NCT04320823|OG001|Outcome|Control Group With BMI ≤ 30 Lbs|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347159|NCT04320823|OG002|Outcome|Experimental Group With BMI > 30|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347160|NCT04320823|OG003|Outcome|Control Group With BMI > 30|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347161|NCT04320823|OG000|Outcome|Experimental Group - First-Time Donor|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347162|NCT04320823|OG001|Outcome|Control Group - First-Time Donor|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347163|NCT04320823|OG002|Outcome|Experimental Group - Repeat Donor|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347164|NCT04320823|OG003|Outcome|Control Group - Repeat Donor|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347165|NCT04320823|OG000|Outcome|Experimental Group - Female Donor|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347166|NCT04320823|OG001|Outcome|Control Group - Female Donor|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347167|NCT04320823|OG002|Outcome|Experimental Group - Male Donor|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347168|NCT04320823|OG003|Outcome|Control Group - Male Donor|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347169|NCT04320823|EG000|Reported Event|Experimental Group|"Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.~Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach."
11347170|NCT04320823|EG001|Reported Event|Control Group|"Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.~Current Plasma Collection Approach: Plasma collection using the current collection approach."
11347171|NCT04320615|BG000|Baseline|Placebo Modified Intent-to-Treat (mITT) Arm|Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347172|NCT04320615|BG001|Baseline|Tocilizumab (TCZ) mITT Arm|Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347173|NCT04320615|BG002|Baseline|Total|Total of all reporting groups
11347174|NCT04320615|FG000|Participant Flow|Placebo Modified Intent-to-Treat (mITT) Arm|Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347175|NCT04320615|FG001|Participant Flow|Tocilizumab (TCZ) mITT Arm|Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347176|NCT04320615|OG000|Outcome|Tocilizumab (TCZ) mITT Arm|Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347177|NCT04320615|OG001|Outcome|Placebo Modified Intent-to-Treat (mITT) Arm|Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347178|NCT04320615|OG002|Outcome|TCZ - No Mechanical Ventilation at Baseline|Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347179|NCT04320615|OG003|Outcome|Placebo - No Mechanical Ventilation at Baseline|Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347180|NCT04320615|OG002|Outcome|TCZ - Not in ICU at Baseline|Participants randomized to the TCZ arm who received any amount of study drug and were not in the ICU at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347181|NCT04320615|OG003|Outcome|Placebo - Not in ICU at Baseline|Participants randomized to the placebo arm who received any amount of study drug and were not in the ICU at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
11347182|NCT04320615|EG000|Reported Event|Placebo Arm (Safety-Evaluable Population)|The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
11347183|NCT04320615|EG001|Reported Event|Tocilizumab (TCZ) Arm (Safety-Evaluable Population)|The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
11347184|NCT04318535|BG000|Baseline|All Treated Participants|All participants received a single oral dose of Griseofulvin 500 mg tablet (T1), Griseofulvin 250 mg tablet (T2) and Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
11347185|NCT04318535|FG000|Participant Flow|Griseofulvin 500-T1/Griseofulvin 250-T2/Griseofulvin 500-R|Participants received a single oral dose of Griseofulvin 500 mg (Treatment 1 [T1]) in treatment period 1 (Day 1) followed by Griseofulvin 250 mg (T2) in treatment period 2 (Day 8) followed by Griseofulvin 500 mg (Reference [R]) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
11347186|NCT04318535|FG001|Participant Flow|Griseofulvin 250-T2/Griseofulvin 500-R/Griseofulvin 500-T1|Participants received a single oral dose of Griseofulvin 250 mg (T2) in treatment period 1 (Day 1) followed by Griseofulvin 500 mg (R) in treatment period 2 (Day 8) followed by Griseofulvin 500 mg (T1) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
11347187|NCT04318535|FG002|Participant Flow|Griseofulvin 500-R/Griseofulvin 500-T1/Griseofulvin 250-T2|Participants received a single oral dose of Griseofulvin 500 mg (R) in treatment period 1 (Day 1) followed by Griseofulvin 500 mg (T1) in treatment period 2 (Day 8) followed by Griseofulvin 250 mg (T2) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
11347188|NCT04318535|OG000|Outcome|Griseofulvin 500 mg (T1)|All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
11347189|NCT04318535|OG001|Outcome|Griseofulvin 250 mg (T2)|All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
11347190|NCT04318535|OG002|Outcome|Griseofulvin 500 mg (R)|All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
11347191|NCT04318535|OG000|Outcome|Griseofulvin 250 mg to 500 mg|All participants received a single oral dose of Griseofulvin 250 mg or 500 mg tablet in either Period 1 or Period 2 or Period 3 as per randomization schedule.
11347192|NCT04318535|EG000|Reported Event|Griseofulvin 500 mg (T1)|All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
11347193|NCT04318535|EG001|Reported Event|Griseofulvin 250 mg (T2)|All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
11347194|NCT04318535|EG002|Reported Event|Griseofulvin 500 mg (R)|All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
11347195|NCT04316260|BG000|Baseline|Smoking Cessation Electronic Visit (E-visit)|"This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.~Smoking cessation e-visit: electronic visits (e-visits) for smoking cessation"
11347196|NCT04316260|BG001|Baseline|Treatment As Usual|"This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.~Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking"
11347197|NCT04316260|BG002|Baseline|Total|Total of all reporting groups
11347198|NCT04316260|FG000|Participant Flow|Smoking Cessation Electronic Visit (E-visit)|"This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.~Smoking cessation e-visit: electronic visits (e-visits) for smoking cessation"
11347199|NCT04316260|FG001|Participant Flow|Treatment As Usual|"This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.~Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking"
11347200|NCT04316260|OG000|Outcome|Smoking Cessation Electronic Visit (E-visit)|"This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.~Smoking cessation e-visit: electronic visits (e-visits) for smoking cessation"
11347201|NCT04316260|OG001|Outcome|Treatment As Usual|"This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.~Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking"
11347202|NCT04316260|OG000|Outcome|Smoking Cessation E-visit (Electronic Visit) Group|"This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.~Smoking cessation e-visit: electronic visits (e-visits) for smoking cessation"
11347203|NCT04316260|EG000|Reported Event|Smoking Cessation Electronic Visit (E-visit)|"This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.~Smoking cessation e-visit: electronic visits (e-visits) for smoking cessation"
11347204|NCT04316260|EG001|Reported Event|Treatment As Usual|"This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.~Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking"
11347205|NCT04314037|BG000|Baseline|First Cesol, Then Biltricide, Then Cesol and Then Biltricide|Participants received first single oral dose of 1200 milligrams (mg) (two 600 mg film-coated tablets) Cesol (Test 1) on Day 1 in treatment period 1 followed by first single oral dose of 1200 mg (two 600 mg film-coated tablets) Biltricide (Reference 1) on Day 8 in treatment period 2 followed by second single oral dose of 1200 mg (two 600 mg film-coated tablets) Cesol (Test 2) on Day 15 in treatment period 3 followed by second single oral dose of 1200 mg (two 600 mg film-coated tablets) Biltricide (Reference 2) on Day 22 in treatment period 4 under fed conditions. A washout period of 7 days was maintained between 4 treatment periods.
11347206|NCT04314037|BG001|Baseline|First Biltricide, Then Cesol, Then Biltricide and Then Cesol|Participants received first single oral dose of 1200 mg (two 600 mg film-coated tablets) Biltricide (Reference 1) on Day 1 in treatment period 1 followed by first single oral dose of 1200 mg (two 600 mg film-coated tablets) Cesol (Test 1) on Day 8 in treatment period 2 followed by second single oral dose of 1200 mg (two 600 mg film-coated tablets) Biltricide (Reference 2) on Day 15 in treatment period 3 followed by second single oral dose of 1200 mg (two 600 mg film-coated tablets) Cesol (Test 2) on Day 22 in treatment period 4 under fed conditions. A washout period of 7 days was maintained between 4 treatment periods.
11347207|NCT04314037|BG002|Baseline|Total|Total of all reporting groups
11347208|NCT04314037|FG000|Participant Flow|First Cesol, Then Biltricide, Then Cesol and Then Biltricide|Participants received first single oral dose of 1200 milligrams (mg) (two 600 mg film-coated tablets) Cesol (Test 1) on Day 1 in treatment period 1 followed by first single oral dose of 1200 mg (two 600 mg film-coated tablets) Biltricide (Reference 1) on Day 8 in treatment period 2 followed by second single oral dose of 1200 mg (two 600 mg film-coated tablets) Cesol (Test 2) on Day 15 in treatment period 3 followed by second single oral dose of 1200 mg (two 600 mg film-coated tablets) Biltricide (Reference 2) on Day 22 in treatment period 4 under fed conditions. A washout period of 7 days was maintained between 4 treatment periods.
11347209|NCT04314037|FG001|Participant Flow|First Biltricide, Then Cesol, Then Biltricide and Then Cesol|Participants received first single oral dose of 1200 mg (two 600 mg film-coated tablets) Biltricide (Reference 1) on Day 1 in treatment period 1 followed by first single oral dose of 1200 mg (two 600 mg film-coated tablets) Cesol (Test 1) on Day 8 in treatment period 2 followed by second single oral dose of 1200 mg (two 600 mg film-coated tablets) Biltricide (Reference 2) on Day 15 in treatment period 3 followed by second single oral dose of 1200 mg (two 600 mg film-coated tablets) Cesol (Test 2) on Day 22 in treatment period 4 under fed conditions. A washout period of 7 days was maintained between 4 treatment periods.
11347210|NCT04314037|OG000|Outcome|Cesol First Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Cesol (Test 1) in either Treatment Period 1 or 2 under fed conditions.
11347211|NCT04314037|OG001|Outcome|Cesol Second Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Cesol (Test 2) in either Treatment Period 3 or 4 under fed conditions.
11347212|NCT04314037|OG002|Outcome|Biltricide First Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference 1) in either Treatment Period 1 or 2 under fed conditions.
11347213|NCT04314037|OG003|Outcome|Biltricide Second Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference 2) in either Treatment Period 3 or 4 under fed conditions.
11347214|NCT04314037|OG003|Outcome|Biltricide Second Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference 2) in either Treatment Period 3 or 4 under fed conditions
11347215|NCT04314037|OG003|Outcome|Biltricide Second Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference 2) in either Treatment Period 1 or 2 under fed conditions.
11347216|NCT04314037|EG000|Reported Event|Cesol First Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Cesol (Test 1) in either Treatment Period 1 or 2 under fed conditions.
11347217|NCT04314037|EG001|Reported Event|Cesol Second Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Cesol (Test 2) in either Treatment Period 3 or 4 under fed conditions.
11347218|NCT04314037|EG002|Reported Event|Biltricide First Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference 1) in either Treatment Period 1 or 2 under fed conditions.
11347219|NCT04314037|EG003|Reported Event|Biltricide Second Administration|Participants who received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference 2) in either Treatment Period 3 or 4 under fed conditions.
11347220|NCT04315298|BG000|Baseline|Phase 2: Placebo|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347221|NCT04315298|BG001|Baseline|Phase 2: Sarilumab 200mg IV|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347222|NCT04315298|BG002|Baseline|Phase 2: Sarilumab 400mg IV|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347223|NCT04315298|BG003|Baseline|Phase 3 Cohort 1: Placebo - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347224|NCT04315298|BG004|Baseline|Phase 3 Cohort 1: Sarilumab 200mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347225|NCT04315298|BG005|Baseline|Phase 3 Cohort 1: Sarilumab 400mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347226|NCT04315298|BG006|Baseline|Phase 3 Cohort 1: Placebo - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347227|NCT04315298|BG007|Baseline|Phase 3 Cohort 1: Sarilumab 200mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347228|NCT04315298|BG008|Baseline|Phase 3 Cohort 1 :Sarilumab 400mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347229|NCT04315298|BG009|Baseline|Phase 3 Cohort 1: Placebo - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347230|NCT04315298|BG010|Baseline|Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347231|NCT04315298|BG011|Baseline|Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347232|NCT04315298|BG012|Baseline|Phase 3 Cohort 1: Placebo - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347233|NCT04315298|BG013|Baseline|Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347234|NCT04315298|BG014|Baseline|Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347235|NCT04315298|BG015|Baseline|Phase 3 Cohort 2: Placebo|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347236|NCT04315298|BG016|Baseline|Phase 3 Cohort 2: Sarilumab 800mg IV|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347237|NCT04315298|BG017|Baseline|Phase 3 Cohort 3: Placebo|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347238|NCT04315298|BG018|Baseline|Phase 3 Cohort 3: Sarilumab 800mg IV|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347239|NCT04315298|BG019|Baseline|Total|Total of all reporting groups
11347240|NCT04315298|FG000|Participant Flow|Phase 2: Placebo|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347241|NCT04315298|FG001|Participant Flow|Phase 2: Sarilumab 200mg IV|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347242|NCT04315298|FG002|Participant Flow|Phase 2: Sarilumab 400mg IV|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347243|NCT04315298|FG003|Participant Flow|Phase 3 Cohort 1: Placebo - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347244|NCT04315298|FG004|Participant Flow|Phase 3 Cohort 1: Sarilumab 200mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347245|NCT04315298|FG005|Participant Flow|Phase 3 Cohort 1: Sarilumab 400mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347246|NCT04315298|FG006|Participant Flow|Phase 3 Cohort 1: Placebo - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347247|NCT04315298|FG007|Participant Flow|Phase 3 Cohort 1: Sarilumab 200mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347248|NCT04315298|FG008|Participant Flow|Phase 3 Cohort 1: Sarilumab 400mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347249|NCT04315298|FG009|Participant Flow|Phase 3 Cohort 1: Placebo - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347250|NCT04315298|FG010|Participant Flow|Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347251|NCT04315298|FG011|Participant Flow|Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347252|NCT04315298|FG012|Participant Flow|Phase 3 Cohort 1: Placebo - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347253|NCT04315298|FG013|Participant Flow|Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347254|NCT04315298|FG014|Participant Flow|Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347255|NCT04315298|FG015|Participant Flow|Phase 3 Cohort 2: Placebo|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347256|NCT04315298|FG016|Participant Flow|Phase 3 Cohort 2: Sarilumab 800mg IV|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347257|NCT04315298|FG017|Participant Flow|Phase 3 Cohort 3: Placebo|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347258|NCT04315298|FG018|Participant Flow|Phase 3 Cohort 3: Sarilumab 800mg IV|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347259|NCT04315298|OG000|Outcome|Phase 2: Placebo|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347260|NCT04315298|OG001|Outcome|Phase 2: Sarilumab 200mg IV|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347261|NCT04315298|OG002|Outcome|Phase 2: Sarilumab 400mg IV|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347262|NCT04315298|OG000|Outcome|Phase 3 Cohort 1: Placebo - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347263|NCT04315298|OG001|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347264|NCT04315298|OG002|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347265|NCT04315298|OG000|Outcome|Phase 3 Cohort 2: Placebo|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347266|NCT04315298|OG001|Outcome|Phase 3 Cohort 2: Sarilumab 800mg IV|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347267|NCT04315298|OG003|Outcome|Phase 3 Cohort 1: Placebo - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347268|NCT04315298|OG004|Outcome|Phase 3 Cohort 1: 200mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347269|NCT04315298|OG005|Outcome|Phase 3 Cohort 1:Sarilumab 400mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347270|NCT04315298|OG006|Outcome|Phase 3 Cohort 1: Placebo - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347271|NCT04315298|OG007|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347272|NCT04315298|OG008|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347273|NCT04315298|OG009|Outcome|Phase 3 Cohort 1: Placebo - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD)[vasopressors, extracorporeal life support, or renal replacement therapy]"
11347274|NCT04315298|OG010|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347275|NCT04315298|OG011|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
10976732|NCT00942084|EG000|Reported Event|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
10976733|NCT00942149|BG000|Baseline|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
10976734|NCT00942149|FG000|Participant Flow|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
10976735|NCT00942149|OG000|Outcome|Area Under the Curve - 24 Hours|pharmacokinetics of daptomycin
10976736|NCT00942149|EG000|Reported Event|Daptomycin Cohort|
11347276|NCT04315298|OG012|Outcome|Phase 3 Cohort 1: Placebo - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347277|NCT04315298|OG013|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347278|NCT04315298|OG014|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347279|NCT04315298|OG015|Outcome|Phase 3 Cohort 2: Placebo|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347280|NCT04315298|OG016|Outcome|Phase 3 Cohort 2: Sarilumab 800 mg IV|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347281|NCT04315298|OG017|Outcome|Phase 3 Cohort 3: Placebo|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347282|NCT04315298|OG018|Outcome|Phase 3 Cohort 3: Sarilumab 800 mg IV|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347283|NCT04315298|OG001|Outcome|Phase 3 Cohort 1: 200mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347284|NCT04315298|OG004|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347285|NCT04315298|OG005|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347286|NCT04315298|OG009|Outcome|Phase 3 Cohort 1: Placebo - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347287|NCT04315298|OG010|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD)[vasopressors, extracorporeal life support, or renal replacement therapy]"
11347288|NCT04315298|OG011|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD)[vasopressors, extracorporeal life support, or renal replacement therapy]"
11347289|NCT04315298|OG003|Outcome|Phase 3 Cohort 1: Placebo - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347290|NCT04315298|OG004|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347291|NCT04315298|OG005|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347292|NCT04315298|OG006|Outcome|Phase 3 Cohort 1: Placebo - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347293|NCT04315298|OG007|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347294|NCT04315298|OG008|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347295|NCT04315298|OG009|Outcome|Phase 3 Cohort 1: Placebo - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347296|NCT04315298|OG010|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347297|NCT04315298|OG011|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347298|NCT04315298|OG012|Outcome|Phase 3 Cohort 2: Placebo|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347299|NCT04315298|OG013|Outcome|Phase 3 Cohort 2: Sarilumab 800 mg IV|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347300|NCT04315298|OG014|Outcome|Phase 3 Cohort 3: Placebo|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347301|NCT04315298|OG015|Outcome|Phase 3 Cohort 3: Sarilumab 800 mg IV|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347302|NCT04315298|OG006|Outcome|Phase 3 Cohort 1: Placebo - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD)[vasopressors, extracorporeal life support, or renal replacement therapy]"
11347303|NCT04315298|OG007|Outcome|Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD)[vasopressors, extracorporeal life support, or renal replacement therapy]"
11347304|NCT04315298|OG008|Outcome|Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD)[vasopressors, extracorporeal life support, or renal replacement therapy]"
11347305|NCT04315298|EG000|Reported Event|Phase 2: Placebo|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
10976737|NCT00942162|BG000|Baseline|GSK2132231A GS+ Group|Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10976738|NCT00942162|BG001|Baseline|GSK2132231A GS- Group|Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10976739|NCT00942162|BG002|Baseline|GSK2132231A GS-unknown Group|Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10976740|NCT00942162|BG003|Baseline|Total|Total of all reporting groups
11347306|NCT04315298|EG001|Reported Event|Phase 2: Sarilumab 200mg IV|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347307|NCT04315298|EG002|Reported Event|Phase 2: Sarilumab 400mg IV|"Hospitalized with SARS-CoV-2 infection and one of the following disease strata:~Severe disease~Critical disease~Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment"
11347308|NCT04315298|EG003|Reported Event|Phase 3 Cohort 1: Placebo - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347309|NCT04315298|EG004|Reported Event|Phase 3 Cohort 1: Sarilumab 200mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347310|NCT04315298|EG005|Reported Event|Phase 3 Cohort 1: Sarilumab 400mg IV - Critical|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)"
11347311|NCT04315298|EG006|Reported Event|Phase 3 Cohort 1: Placebo - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347312|NCT04315298|EG007|Reported Event|Phase 3 Cohort 1: Sarilumab 200mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347313|NCT04315298|EG008|Reported Event|Phase 3 Cohort 1: Sarilumab 400mg IV - Severe|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)"
11347314|NCT04315298|EG009|Reported Event|Phase 3 Cohort 1: Placebo - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347315|NCT04315298|EG010|Reported Event|Phase 3 Cohort 1: Sarilumab 200 mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347316|NCT04315298|EG011|Reported Event|Phase 3 Cohort 1: Sarilumab 400 mg IV - MSOD|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Multi-system organ dysfunction (MSOD) [vasopressors, extracorporeal life support, or renal replacement therapy]"
11347317|NCT04315298|EG012|Reported Event|Phase 3 Cohort 1: Placebo - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347318|NCT04315298|EG013|Reported Event|Phase 3 Cohort 1: Sarilumab 200 mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347319|NCT04315298|EG014|Reported Event|Phase 3 Cohort 1: Sarilumab 400 mg IV - Immunocompromised|"Hospitalized with SARS-CoV-2 infection and in the following disease strata:~-Immunocompromised or on immunosuppressive treatment"
11347320|NCT04315298|EG015|Reported Event|Phase 3 Cohort 2: Placebo|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347321|NCT04315298|EG016|Reported Event|Phase 3 Cohort 2: Sarilumab 800 mg IV|Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
11347322|NCT04315298|EG017|Reported Event|Phase 3 Cohort 3: Placebo|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347323|NCT04315298|EG018|Reported Event|Phase 3 Cohort 3: Sarilumab 800 mg IV|Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
11347324|NCT04313647|BG000|Baseline|1X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml)~1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml)"
11347325|NCT04313647|BG001|Baseline|2X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0*10E8 nano vesicles/3 ml)~2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0*10E8 nano vesicles/3 ml)"
11347326|NCT04313647|BG002|Baseline|4X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0*10E8 nano vesicles/3 ml)~4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0*10E8 nano vesicles/3 ml)"
11347327|NCT04313647|BG003|Baseline|6X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0*10E8 nano vesicles/3 ml)~6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0*10E8 nano vesicles/3 ml)"
11347328|NCT04313647|BG004|Baseline|8X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0*10E8 nano vesicles/3 ml)~8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0*10E8 nano vesicles/3 ml)"
11347329|NCT04313647|BG005|Baseline|Total|Total of all reporting groups
11347330|NCT04313647|FG000|Participant Flow|1X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml)~1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml)"
11347331|NCT04313647|FG001|Participant Flow|2X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0*10E8 nano vesicles/3 ml)~2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0*10E8 nano vesicles/3 ml)"
11347332|NCT04313647|FG002|Participant Flow|4X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0*10E8 nano vesicles/3 ml)~4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0*10E8 nano vesicles/3 ml)"
10976741|NCT00942162|FG000|Participant Flow|GSK2132231A GS+ Group|Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
11347333|NCT04313647|FG003|Participant Flow|6X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0*10E8 nano vesicles/3 ml)~6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0*10E8 nano vesicles/3 ml)"
11347334|NCT04313647|FG004|Participant Flow|8X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0*10E8 nano vesicles/3 ml)~8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0*10E8 nano vesicles/3 ml)"
11347335|NCT04313647|OG000|Outcome|1X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml)~1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml)"
11347336|NCT04313647|OG001|Outcome|2X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0*10E8 nano vesicles/3 ml)~2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0*10E8 nano vesicles/3 ml)"
11347337|NCT04313647|OG002|Outcome|4X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0*10E8 nano vesicles/3 ml)~4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0*10E8 nano vesicles/3 ml)"
11347338|NCT04313647|OG003|Outcome|6X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0*10E8 nano vesicles/3 ml)~6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0*10E8 nano vesicles/3 ml)"
11347339|NCT04313647|OG004|Outcome|8X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0*10E8 nano vesicles/3 ml)~8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0*10E8 nano vesicles/3 ml)"
11347340|NCT04313647|OG000|Outcome|1X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)~1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)"
11347341|NCT04313647|OG001|Outcome|2X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)~2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)"
11347342|NCT04313647|OG002|Outcome|4X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)~4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)"
11347343|NCT04313647|OG003|Outcome|6X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)~6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)"
11347344|NCT04313647|OG004|Outcome|8X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)~8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)"
11347345|NCT04313647|EG000|Reported Event|1X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml)~1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml)"
11347346|NCT04313647|EG001|Reported Event|2X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0*10E8 nano vesicles/3 ml)~2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0*10E8 nano vesicles/3 ml)"
11347347|NCT04313647|EG002|Reported Event|4X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0*10E8 nano vesicles/3 ml)~4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0*10E8 nano vesicles/3 ml)"
11347348|NCT04313647|EG003|Reported Event|6X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0*10E8 nano vesicles/3 ml)~6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0*10E8 nano vesicles/3 ml)"
11347349|NCT04313647|EG004|Reported Event|8X Level|"Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0*10E8 nano vesicles/3 ml)~8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0*10E8 nano vesicles/3 ml)"
11347350|NCT04310085|BG000|Baseline|PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 1|"8 healthy, malaria-naïve males and females, aged 18-55 years, will be enrolled per cohort; a participant may be enrolled in one cohort only. The target level of parasitaemia for cohort 1, previously achieved in healthy participants enrolled in malaria VIS at other study sites, is 5000 parasites/mL blood.~qPCR will be performed and malaria clinical score assessed twice daily and participants will be administered registered antimalarial therapy, i.e., Riamet®, when the following criteria are met:~Cohort 1: ≥5000 parasites/mL blood or earlier if a participant has a malaria clinical score >6 or at Investigator's discretion.~Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet: artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h~PfSPZ-DVI Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11348595|NCT04158466|BG000|Baseline|Kalifilcon A Daily Disposable Contact Lenses|"Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.~Kalifilcon A Daily Disposable Contact Lenses: Contact lens"
10976742|NCT00942162|FG001|Participant Flow|GSK2132231A GS- Group|Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10848854|NCT00292045|EG000|Reported Event|NY-ESO-1 Protein + CpG 7909|Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle). Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression.
10976743|NCT00942162|FG002|Participant Flow|GSK2132231A GS-unknown Group|Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10976744|NCT00942162|OG000|Outcome|GSK2132231A GS+ Group|Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10976745|NCT00942162|OG001|Outcome|GSK2132231A GS- Group|Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10976746|NCT00942162|OG002|Outcome|GSK2132231A GS-unknown Group|Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10976747|NCT00942162|OG000|Outcome|Overall Study Group|Group of all patients (GS+, GS- and Unknown GS) planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles.
10848855|NCT00292162|BG000|Baseline|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
10976748|NCT00942162|OG001|Outcome|GSK2132231A GS+ Group|Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
11347351|NCT04310085|BG001|Baseline|PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 2|"8 healthy, malaria-naïve males and females, aged 18-55 years, will be enrolled per cohort; a participant may be enrolled in one cohort only. The target level of parasitaemia for cohort 2, previously achieved in healthy participants enrolled in malaria VIS at other study sites, is 10,000 parasites/mL blood.~qPCR will be performed and malaria clinical score assessed twice daily and participants will be administered registered antimalarial therapy, i.e., Riamet®, when the following criteria are met:~Cohort 2: ≥10000 parasites/mL blood or earlier if a participant has a malaria clinical score >6 or at Investigator's discretion.~Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet: artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h~PfSPZ-DVI Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11347352|NCT04310085|BG002|Baseline|Total|Total of all reporting groups
11347353|NCT04310085|FG000|Participant Flow|PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 1|"8 healthy, malaria-naïve males and females, aged 18-55 years, will be enrolled. The target level of parasitaemia, previously achieved in healthy participants enrolled in malaria VIS at other study sites (see Section 3.2), is 5000 parasites/mL blood in Cohort 1.~qPCR will be performed and malaria clinical score assessed twice daily and participants will be administered registered antimalarial therapy, i.e., Riamet® (see Section 5.1), when the following criteria are met: Cohort 1: ≥5000 parasites/mL blood or earlier if a participant has a malaria clinical score >6 or at Investigator's discretion.~Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet: artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h~PfSPZ-DVI Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11347354|NCT04310085|FG001|Participant Flow|PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 2|"8 healthy, malaria-naïve males and females, aged 18-55 years, will be enrolled. The target level of parasitaemia, previously achieved in healthy participants enrolled in malaria VIS at other study sites (see Section 3.2), is 10000 parasites/mL blood in Cohort 2.~qPCR will be performed and malaria clinical score assessed twice daily and participants will be administered registered antimalarial therapy, i.e., Riamet® (see Section 5.1), when the following criteria are met: Cohort 2: ≥10000 parasites/mL blood or earlier if a participant has a malaria clinical score >6 or at Investigator's discretion.~Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet: artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h~PfSPZ-DVI Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11347355|NCT04310085|OG000|Outcome|PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 1|"8 healthy, malaria-naïve males and females, aged 18-55 years, will be enrolled per cohort; a participant may be enrolled in one cohort only. The target level of parasitaemia for cohort 1, previously achieved in healthy participants enrolled in malaria VIS at other study sites, is 5000 parasites/mL blood.~qPCR will be performed and malaria clinical score assessed twice daily and participants will be administered registered antimalarial therapy, i.e., Riamet®, when the following criteria are met:~Cohort 1: ≥5000 parasites/mL blood or earlier if a participant has a malaria clinical score >6 or at Investigator's discretion.~Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet: artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h~PfSPZ-DVI Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11347356|NCT04310085|OG001|Outcome|PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 2|"8 healthy, malaria-naïve males and females, aged 18-55 years, will be enrolled per cohort; a participant may be enrolled in one cohort only. The target level of parasitaemia for cohort 2, previously achieved in healthy participants enrolled in malaria VIS at other study sites, is 10,000 parasites/mL blood.~qPCR will be performed and malaria clinical score assessed twice daily and participants will be administered registered antimalarial therapy, i.e., Riamet®, when the following criteria are met:~Cohort 2: ≥10000 parasites/mL blood or earlier if a participant has a malaria clinical score >6 or at Investigator's discretion.~Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet: artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h~PfSPZ-DVI Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11347357|NCT04310085|EG000|Reported Event|PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 1|"8 healthy, malaria-naïve males and females, aged 18-55 years, will be enrolled per cohort; a participant may be enrolled in one cohort only. The target level of parasitaemia for cohort 1, previously achieved in healthy participants enrolled in malaria VIS at other study sites, is 5000 parasites/mL blood.~qPCR will be performed and malaria clinical score assessed twice daily and participants will be administered registered antimalarial therapy, i.e., Riamet®, when the following criteria are met:~Cohort 1: ≥5000 parasites/mL blood or earlier if a participant has a malaria clinical score >6 or at Investigator's discretion.~Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet: artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h~PfSPZ-DVI Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11347358|NCT04310085|EG001|Reported Event|PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 2|"8 healthy, malaria-naïve males and females, aged 18-55 years, will be enrolled per cohort; a participant may be enrolled in one cohort only. The target level of parasitaemia for cohort 2, previously achieved in healthy participants enrolled in malaria VIS at other study sites, is 10,000 parasites/mL blood.~qPCR will be performed and malaria clinical score assessed twice daily and participants will be administered registered antimalarial therapy, i.e., Riamet®, when the following criteria are met:~Cohort 2: ≥10000 parasites/mL blood or earlier if a participant has a malaria clinical score >6 or at Investigator's discretion.~Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet: artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h~PfSPZ-DVI Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11347359|NCT04309617|BG000|Baseline|All Participants|Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
11347360|NCT04309617|FG000|Participant Flow|All Participants|Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
11347361|NCT04309617|OG000|Outcome|All Participants|Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
10848856|NCT00292162|BG001|Baseline|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
10848857|NCT00292162|BG002|Baseline|Total|Total of all reporting groups
11347362|NCT04309617|OG000|Outcome|All Participants|Eligible participants diagnosed with loco regional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
11347363|NCT04309617|OG000|Outcome|Participants at Modified High Risk for Recurrence|Participants diagnosed with locoregional RCC who underwent nephrectomy at Duke from 01 April 2014 to 31 December 2019, at modified high risk for recurrence were included. Participants at modified high risk were those who had a T stage of 3a or higher combined with a tumor grade of 2 or higher, regional lymph-node metastasis, or both.
11347364|NCT04309617|EG000|Reported Event|All Participants|Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
11347365|NCT04308239|BG000|Baseline|Reactive Balance Training|Group of participants who were assigned to reactive balance training.
11347366|NCT04308239|BG001|Baseline|Control Balance Training|Group of participants who were assigned to control balance training.
11347367|NCT04308239|BG002|Baseline|Total|Total of all reporting groups
11347368|NCT04308239|FG000|Participant Flow|Reactive Balance Training|"Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Training in each session was 30 minutes for each participant.~Reactive balance training involved both slip and trip training.~Slip training involved repeatedly stepping onto a low-friction interface (nylon fabric placed over a 0.9 × 0.9 meter polycarbonate sheet) while practicing controlling/decelerating the slipping foot and properly positioning the non-slipping foot under the pelvis.~Trip training involved repeatedly practicing recovery from simulated trips on a modified treadmill. While standing on a modified treadmill, the treadmill belt was quickly accelerated posteriorly to elicit a forward loss of balance that mimicked a trip while walking. Participants attempted to step to avert a fall, and to establish a stable gait on the treadmill, after which the treadmill speed was slowed to zero to complete the trial."
11347369|NCT04308239|FG001|Participant Flow|Control Balance Training|"Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant.~The control intervention involved general balance exercises adapted from the Otago Exercise program. Briefly, all four sessions involved balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).~Otago Balance Training: Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support)."
11347370|NCT04308239|OG000|Outcome|Baseline SLIP Group|Group of participants who were slipped prior to intervention.
11347371|NCT04308239|OG000|Outcome|Post-Control Balance Training SLIP Group|Group of participants who were slipped after the control balance training intervention.
11347372|NCT04308239|OG001|Outcome|Post-Reactive Balance Training SLIP Group|Group of participants who were slipped after the reactive balance training intervention.
11347373|NCT04308239|OG000|Outcome|Baseline TRIP Group|Group of participants who were tripped prior to intervention.
11347374|NCT04308239|OG000|Outcome|Post-Control Balance Training TRIP Group|Group of participants who were tripped after the control balance training intervention.
11347375|NCT04308239|OG001|Outcome|Post-Reactive Balance Training TRIP Group|Group of participants who were tripped after the reactive balance training intervention.
11347376|NCT04308239|EG000|Reported Event|Reactive Balance Training|Participants assigned to the reactive balance training.
11347377|NCT04308239|EG001|Reported Event|Control Balance Training|Participants assigned to the control balance training.
11347378|NCT04308668|BG000|Baseline|Treatment|"Participants in this arm will receive the study drug.~Hydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days"
11347379|NCT04308668|BG001|Baseline|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days"
11347380|NCT04308668|BG002|Baseline|Total|Total of all reporting groups
11347381|NCT04308668|FG000|Participant Flow|Treatment|"Participants in this arm will receive the study drug.~Hydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days"
11347382|NCT04308668|FG001|Participant Flow|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days"
11347383|NCT04308668|OG000|Outcome|Treatment|"Participants in this arm will receive the study drug.~Hydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days"
11347384|NCT04308668|OG001|Outcome|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days"
11347385|NCT04308668|EG000|Reported Event|Treatment|"Participants in this arm will receive the study drug.~Hydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days"
11347386|NCT04308668|EG001|Reported Event|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days"
11347387|NCT04307940|BG000|Baseline|Naproxen Sodium|Participants received a single dose of naproxen sodium tablets 440 mg (220 mg × 2 tablets) after surgical teeth extractions
11347388|NCT04307940|BG001|Baseline|Hydrocodone / APAP|Participants received a single dose of hydrocodone/acetaminophen tablets 10/650 mg (5/325 mg × 2 tablets) after surgical teeth extractions
11347389|NCT04307940|BG002|Baseline|Placebo|Participants received a single dose of matching placebo tablets (2 tablets) after surgical teeth extractions
11347390|NCT04307940|BG003|Baseline|Total|Total of all reporting groups
11347391|NCT04307940|FG000|Participant Flow|Naproxen Sodium|Participants received a single dose of naproxen sodium tablets 440 mg (220 mg × 2 tablets) after surgical teeth extractions
11347392|NCT04307940|FG001|Participant Flow|Hydrocodone / APAP|Participants received a single dose of hydrocodone/acetaminophen tablets 10/650 mg (5/325 mg × 2 tablets) after surgical teeth extractions
11347393|NCT04307940|FG002|Participant Flow|Placebo|Participants received a single dose of matching placebo tablets (2 tablets) after surgical teeth extractions
11347394|NCT04307940|OG000|Outcome|Naproxen Sodium|Participants received a single dose of naproxen sodium tablets 440 mg (220 mg × 2 tablets) after surgical teeth extractions
11347395|NCT04307940|OG001|Outcome|Hydrocodone / APAP|Participants received a single dose of hydrocodone/acetaminophen tablets 10/650 mg (5/325 mg × 2 tablets) after surgical teeth extractions
11347396|NCT04307940|OG002|Outcome|Placebo|Participants received a single dose of matching placebo tablets (2 tablets) after surgical teeth extractions
11347397|NCT04307940|EG000|Reported Event|Naproxen Sodium|Participants received a single dose of naproxen sodium tablets 440 mg (220 mg × 2 tablets) after surgical teeth extractions
11347398|NCT04307940|EG001|Reported Event|Hydrocodone/APAP|Participants received a single dose of hydrocodone/acetaminophen tablets 10/650 mg (5/325 mg × 2 tablets) after surgical teeth extractions
11347399|NCT04307940|EG002|Reported Event|Placebo|Participants received a single dose of matching placebo tablets (2 tablets) after surgical teeth extractions
11347400|NCT04302545|BG000|Baseline|Cystoinflation Group|Cystoinflation: Bladder will be retro-filled with 300cc saline to distend the bladder to recognize bladder outline in cystoinflation group whenever dense adhesions will be encountered which obscure the bladder either before or after opening the peritoneal cavity. Bladder outline will be recognized by observing its gradual distension during bladder retro-fill .The outcome of cystoinflation group will be divided into distension arm(no bladder injury arm) and bladder injury arm.
11347401|NCT04302545|BG001|Baseline|Control Group|In control group,Pelvic adhesiolysis will be performed with bladder put on free drainage by urinary catheter.The outcome of control arm will be divided into distension arm(no bladder injury arm) and bladder injury arm.
11347402|NCT04302545|BG002|Baseline|Total|Total of all reporting groups
11347403|NCT04302545|FG000|Participant Flow|Distension Arm|Subjects with no bladder injury
11347404|NCT04302545|FG001|Participant Flow|Bladder Injury Arm|Subjects with bladder injury
11347405|NCT04302545|OG000|Outcome|Cystoinflation Group|"Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.~Outcome will be studied as bladder injury arm and Distension arm"
11347406|NCT04302545|OG001|Outcome|Control Group|Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
11347407|NCT04302545|OG000|Outcome|Cystoinflation Group|"Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis.~Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline"
11347408|NCT04302545|OG001|Outcome|Control Group|Pelvic adhesiolysis will be performed without bladder retrofill.
11347409|NCT04302545|OG000|Outcome|Cystoinflation Group|Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc.
11347410|NCT04302545|OG000|Outcome|Cystinflation Group|Subjects in which adhesiolysis is performed after distending bladder with300cc saline.
11347411|NCT04302545|OG001|Outcome|Control Group|Subjects in which adhesiolysis is performed with urinary catheter put on free drainage.
11347412|NCT04302545|OG000|Outcome|Cystoinflation Group|Subjects in which adhesiolysis is performed after distending bladder with 300cc saline.
11347413|NCT04302545|OG001|Outcome|Control Group|Subjects in which adhesiolysis is performed by putting urinary catheter on free drainage
11347414|NCT04302545|OG000|Outcome|Cystoinflation Group|Cystoinflation: Bladder will be retro-filled with 300cc saline to distend the bladder to recognize bladder outline in cystoinflation group whenever dense adhesions will be encountered which obscure the bladder either before or after opening the peritoneal cavity. Bladder outline will be recognized by observing its gradual distension during bladder retro-fill .The outcome of cystoinflation group will be divided into distension arm(no bladder injury arm) and bladder injury arm.
11347415|NCT04302545|OG001|Outcome|Control Group|In control group,Pelvic adhesiolysis will be performed with bladder put on free drainage by urinary catheter.The outcome of control arm will be divided into distension arm(no bladder injury arm) and bladder injury arm.
11347416|NCT04302545|OG000|Outcome|Cystoinflation Group|The adhesiolysis will be carried out after retrograde bladder fill with 300cc saline.
11347417|NCT04302545|OG001|Outcome|Control Group|The adhesiolysis will be carried out with urinary catheter put on free drainage.
11347418|NCT04302545|EG000|Reported Event|Cystoinflation Group|Cystoinflation: Bladder will be retro-filled with 300cc saline to distend the bladder to recognize bladder outline in cystoinflation group whenever dense adhesions will be encountered which obscure the bladder either before or after opening the peritoneal cavity. Bladder outline will be recognized by observing its gradual distension during bladder retro-fill .The outcome of cystoinflation group will be divided into distension arm(no bladder injury arm) and bladder injury arm.
11347419|NCT04302545|EG001|Reported Event|Control Group|In control group,Pelvic adhesiolysis will be performed with bladder put on free drainage by urinary catheter.The outcome of control arm will be divided into distension arm(no bladder injury arm) and bladder injury arm.
11347420|NCT04297631|BG000|Baseline|Vancomycin|"All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels.~Vancomyscin: Everyone gets the vancomyscin powder.~Tobramycin Powder: Everyone gets tobramycin powder."
11347421|NCT04297631|FG000|Participant Flow|Vancomycin|"All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels.~Vancomyscin: Everyone gets the vancomyscin powder.~Tobramycin Powder: Everyone gets tobramycin powder."
11347422|NCT04297631|OG000|Outcome|Intraarticular Concentrations of Tobramycin and Vancomycin|"All patients getting vancomycin and tobramycin to see serum concentration after 24hrs in knee drain and serum levels.~Vancomyscin: Everyone gets the vancomyscin powder.~Tobramycin Powder: Everyone gets tobramycin powder."
11347423|NCT04297631|OG000|Outcome|Vancomycin and Tobramycin Serum Concentration|"All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels.~Vancomyscin: Everyone gets the vancomyscin powder.~Tobramycin Powder: Everyone gets tobramycin powder."
11347424|NCT04297631|EG000|Reported Event|Intraarticular Concentrations of Tobramycin and Vancomycin|"All patients getting vancomycin and tobramycin to see serum concentration after 24hrs in knee drain and serum levels.~Vancomyscin: Everyone gets the vancomyscin powder.~Tobramycin Powder: Everyone gets tobramycin powder."
11347425|NCT04297241|BG000|Baseline|Isosorbide Dinitrate|Isosorbide Dinitrate: This is a prospective study in children and adults with Fontan physiology to see if isosorbide dinitrate will be safely tolerated and improve exercise venous pressure responses, as well as exercise tolerance in Fontan patients. Participants will receive isosorbide dinitrate as a small dose (5 mg three times daily) and titrate up to three times daily over 2 weeks. The medication will continue for 4 weeks once the target dose is reached.
11347426|NCT04297241|FG000|Participant Flow|Isosorbide Dinitrate|"All patients will have a baseline assessment immediately preceding initiation of isosorbide dinitrate. This will include vitals, urine pregnancy test for all females, blood collection, insertion of a peripheral venous cannula for venous blood pressure during exercise testing, maximal cardiopulmonary exercise testing/Ramp protocol including spirometry, and liver ultrasound to assess for liver stiffness.~All patients will then be given a 6 week titration regimen of study medication. Patients will begin at a 5mg dosage and titrate up to 30mg three times per day if each subsequent dose is tolerated.~Four follow-up phone calls will take place every 3 days to ensure the patient is tolerating the medication and a medication adjustment will occur as needed.~Approximately 4 weeks after study drug administration, participants will return for the same tests/procedures as performed during the baseline visit."
11347427|NCT04297241|OG000|Outcome|Isosorbide Dinitrate|Determine the number of participants who experience an adverse reaction to the study medication during the study enrollment period.
11347428|NCT04297241|OG000|Outcome|Isosorbide Dinitrate - Baseline|Determine effectiveness of study medication on hemodynamic profile by completing baseline and post-study medication liver ultrasound measuring liver stiffness levels.
11347429|NCT04297241|OG001|Outcome|Isosorbide Dinitrate - Post-therapy|Determine effectiveness of study medication on hemodynamic profile by completing baseline and post-study medication liver ultrasound measuring liver stiffness levels.
11347430|NCT04297241|OG000|Outcome|Isosorbide Dinitrate - Baseline|Determine effectiveness of study medication on hemodynamic profile by completing baseline and post-study medication maximal exercise tests to measure central venous pressure via IV catheter insertion
11347431|NCT04297241|OG001|Outcome|Isosorbide Dinitrate - Post-therapy|Determine effectiveness of study medication on hemodynamic profile by completing baseline and post-study medication maximal exercise tests to measure central venous pressure via IV catheter insertion
11347432|NCT04297241|OG000|Outcome|Isosorbide Dinitrate - Baseline|Obtain estimates of the effect the study medication has on maximal exercise test VO2 max performance in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.
11347433|NCT04297241|OG001|Outcome|Isosorbide Dinitrate - Post-therapy|Obtain estimates of the effect the study medication has on maximal exercise test VO2 max performance in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.
11347434|NCT04297241|OG000|Outcome|Isosorbide Dinitrate - Baseline|Obtain estimates of the effect the study medication has on maximal exercise test heart rate response in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.
11347435|NCT04297241|OG001|Outcome|Isosorbide Dinitrate - Post-therapy|Obtain estimates of the effect the study medication has on maximal exercise test heart rate response in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.
11347436|NCT04297241|OG000|Outcome|Isosorbide Dinitrate - Baseline|Obtain estimates of the effect the study medication has on maximal exercise test respiratory rate response in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.
11347437|NCT04297241|OG001|Outcome|Isosorbide Dinitrate - Post-therapy|Obtain estimates of the effect the study medication has on maximal exercise test respiratory rate response in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.
11347438|NCT04297241|EG000|Reported Event|Isosorbide Dinitrate|Isosorbide Dinitrate therapy was initiated at a low dose (e.g. 5 mg three times daily in patients above 50 kg) and increased incrementally over 2 weeks to a goal of 30 mg three times a day. The medication was then continued for approximately 4 weeks once the target dose was achieved for a total of 6 weeks.
11347439|NCT04296448|BG000|Baseline|Traditional Otoscope|Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.
11347440|NCT04296448|BG001|Baseline|Cellscope|"Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams.~Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears."
11347441|NCT04296448|BG002|Baseline|Total|Total of all reporting groups
11347442|NCT04296448|FG000|Participant Flow|Traditional Otoscope|Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.
11347443|NCT04296448|FG001|Participant Flow|Cellscope|"Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams.~Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears."
11347444|NCT04296448|OG000|Outcome|Traditional Otoscope|Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.
11347445|NCT04296448|OG001|Outcome|Cellscope|"Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams.~Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears."
11347446|NCT04296448|EG000|Reported Event|Traditional Otoscope|Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.
11347447|NCT04296448|EG001|Reported Event|Cellscope|"Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams.~Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears."
11347448|NCT04296227|BG000|Baseline|ISO 81060-2:2018.|"The intended purpose of the test is to evaluate the Vital Detect blood pressure monitor to ISO 81060-2:2018. The intended use for these products are manual and automatic Non-Invasive Blood Pressure monitoring on adults age 18 and older.~The Vital Detect blood pressure monitor: The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor."
11347449|NCT04296227|FG000|Participant Flow|ISO 81060-2:2018.|"The intended purpose of the test is to evaluate the Vital Detect blood pressure monitor to ISO 81060-2:2018. The intended use for these products are manual and automatic Non-Invasive Blood Pressure monitoring on adults age 18 and older.~The Vital Detect blood pressure monitor: The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor."
11347450|NCT04296227|OG000|Outcome|ISO 81060-2:2018.|"The intended purpose of the test is to evaluate the Vital Detect blood pressure monitor to ISO 81060-2:2018. The intended use for these products are manual and automatic Non-Invasive Blood Pressure monitoring on adults age 18 and older.~The Vital Detect blood pressure monitor: The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor."
11347451|NCT04296227|EG000|Reported Event|ISO 81060-2:2018.|"The intended purpose of the test is to evaluate the Vital Detect blood pressure monitor to ISO 81060-2:2018. The intended use for these products are manual and automatic Non-Invasive Blood Pressure monitoring on adults age 18 and older.~The Vital Detect blood pressure monitor: The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor."
11347452|NCT04295356|BG000|Baseline|Auto Injector|"a single dose (40 mg) of CT-P17 via AI~CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks"
11347453|NCT04295356|BG001|Baseline|Pre-filled Syringe|"a single dose (40 mg) of CT-P17 via PFS~CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks"
11347454|NCT04295356|BG002|Baseline|Total|Total of all reporting groups
11347455|NCT04295356|FG000|Participant Flow|Auto Injector|"a single dose (40 mg) of CT-P17 via AI~CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks"
11347456|NCT04295356|FG001|Participant Flow|Pre-filled Syringe|"a single dose (40 mg) of CT-P17 via PFS~CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks"
11347457|NCT04295356|OG000|Outcome|Auto Injector|"a single dose (40 mg) of CT-P17 via AI~CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks"
11347458|NCT04295356|OG001|Outcome|Pre-filled Syringe|"a single dose (40 mg) of CT-P17 via PFS~CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks"
11347459|NCT04295356|EG000|Reported Event|Auto Injector|"a single dose (40 mg) of CT-P17 via AI~CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks"
11347460|NCT04295356|EG001|Reported Event|Pre-filled Syringe|"a single dose (40 mg) of CT-P17 via PFS~CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks"
11347461|NCT04292639|BG000|Baseline|Respiratory Rate|This study was a comparative, single-center, non-randomized, parallel study, conducted on 20 subjects. The acceptance criteria in this study used a comparison of the Vital USA Vital Detect to a reference Respiratory Rate EtCO2 monitor. Testing was conducted under normal office environment conditions.
11347462|NCT04292639|FG000|Participant Flow|Respiratory Rate|The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Vital USA Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda). This report documents exclusively the results of the Respiratory Rate accuracy performance for the Vital USA Vital Detect.
11347463|NCT04292639|OG000|Outcome|Respiratory Rate|The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).
11347464|NCT04292639|EG000|Reported Event|Respiratory Rate|The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).
11347465|NCT04292535|BG000|Baseline|Passive Control - Placebo|"20 minute sedentary control period during which participants watched an emotionally neutral video.~Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347466|NCT04292535|BG001|Baseline|Passive Control - 20 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347467|NCT04292535|BG002|Baseline|Passive Control - 40 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347468|NCT04292535|BG003|Baseline|Passive Control - 60 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347469|NCT04292535|BG004|Baseline|Passive Control - 80 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347470|NCT04292535|BG005|Baseline|Passive Control - 100 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347471|NCT04292535|BG006|Baseline|Passive Control - 120 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347472|NCT04292535|BG007|Baseline|Acute Exercise - Placebo|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347473|NCT04292535|BG008|Baseline|Acute Exercise - 20 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347474|NCT04292535|BG009|Baseline|Acute Exercise - 40 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347475|NCT04292535|BG010|Baseline|Acute Exercise - 60 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347476|NCT04292535|BG011|Baseline|Acute Exercise - 80 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347477|NCT04292535|BG012|Baseline|Acute Exercise - 100 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347478|NCT04292535|BG013|Baseline|Acute Exercise - 120 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347479|NCT04292535|BG014|Baseline|Total|Total of all reporting groups
11347480|NCT04292535|FG000|Participant Flow|Passive Control - Placebo|"20 minute sedentary control period during which participants watched an emotionally neutral video.~Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347481|NCT04292535|FG001|Participant Flow|Passive Control - 20 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347482|NCT04292535|FG002|Participant Flow|Passive Control - 40 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347483|NCT04292535|FG003|Participant Flow|Passive Control - 60 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347484|NCT04292535|FG004|Participant Flow|Passive Control - 80 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347485|NCT04292535|FG005|Participant Flow|Passive Control - 100 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347486|NCT04292535|FG006|Participant Flow|Passive Control - 120 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347487|NCT04292535|FG007|Participant Flow|Acute Exercise - Placebo|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347488|NCT04292535|FG008|Participant Flow|Acute Exercise - 20 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347489|NCT04292535|FG009|Participant Flow|Acute Exercise - 40 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
10976749|NCT00942162|OG002|Outcome|GSK2132231A GS- Group|Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
11347490|NCT04292535|FG010|Participant Flow|Acute Exercise - 60 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347491|NCT04292535|FG011|Participant Flow|Acute Exercise - 80 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347492|NCT04292535|FG012|Participant Flow|Acute Exercise - 100 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347493|NCT04292535|FG013|Participant Flow|Acute Exercise - 120 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347494|NCT04292535|OG000|Outcome|Passive Control - Placebo|"20 minute sedentary control period during which participants watched an emotionally neutral video.~Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347495|NCT04292535|OG001|Outcome|Passive Control - 20 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347496|NCT04292535|OG002|Outcome|Passive Control - 40 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347497|NCT04292535|OG003|Outcome|Passive Control - 60 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347498|NCT04292535|OG004|Outcome|Passive Control - 80 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347499|NCT04292535|OG005|Outcome|Passive Control - 100 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347500|NCT04292535|OG006|Outcome|Passive Control - 120 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347501|NCT04292535|OG007|Outcome|Acute Exercise - Placebo|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347502|NCT04292535|OG008|Outcome|Acute Exercise - 20 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347503|NCT04292535|OG009|Outcome|Acute Exercise - 40 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347504|NCT04292535|OG010|Outcome|Acute Exercise - 60 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347505|NCT04292535|OG011|Outcome|Acute Exercise - 80 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347506|NCT04292535|OG012|Outcome|Acute Exercise - 100 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347507|NCT04292535|OG013|Outcome|Acute Exercise - 120 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347508|NCT04292535|EG000|Reported Event|Passive Control - Placebo|"20 minute sedentary control period during which participants watched an emotionally neutral video.~Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347509|NCT04292535|EG001|Reported Event|Passive Control - 20 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347510|NCT04292535|EG002|Reported Event|Passive Control - 40 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347511|NCT04292535|EG003|Reported Event|Passive Control - 60 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347512|NCT04292535|EG004|Reported Event|Passive Control - 80 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347513|NCT04292535|EG005|Reported Event|Passive Control - 100 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347514|NCT04292535|EG006|Reported Event|Passive Control - 120 IU|"20 minute sedentary control period during which participants watched an emotionally neutral video.~120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347515|NCT04292535|EG007|Reported Event|Acute Exercise - Placebo|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347516|NCT04292535|EG008|Reported Event|Acute Exercise - 20 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347517|NCT04292535|EG009|Reported Event|Acute Exercise - 40 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347518|NCT04292535|EG010|Reported Event|Acute Exercise - 60 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347519|NCT04292535|EG011|Reported Event|Acute Exercise - 80 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347520|NCT04292535|EG012|Reported Event|Acute Exercise - 100 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347521|NCT04292535|EG013|Reported Event|Acute Exercise - 120 IU|"20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.~120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer"
11347522|NCT04292171|BG000|Baseline|Gabapentin Arm|"Gabapentin 600 mg given 1-2 hours prior to surgical abortion~Gabapentin: Preoperative treatment with Gabapentin"
11347523|NCT04292171|BG001|Baseline|Placebo Arm|"Placebo (vit C) given 1-2 hours prior to surgical abortion~Placebos: Preoperative treatment with Placebo"
11347524|NCT04292171|BG002|Baseline|Total|Total of all reporting groups
11347525|NCT04292171|FG000|Participant Flow|Gabapentin Arm|"Gabapentin 600 mg given 1-2 hours prior to surgical abortion~Gabapentin: Preoperative treatment with Gabapentin"
11347526|NCT04292171|FG001|Participant Flow|Placebo Arm|"Placebo (vit C) given 1-2 hours prior to surgical abortion~Placebos: Preoperative treatment with Placebo"
11347527|NCT04292171|OG000|Outcome|Gabapentin Arm|"Gabapentin 600 mg given 1-2 hours prior to surgical abortion~Gabapentin: Preoperative treatment with Gabapentin"
11347528|NCT04292171|OG001|Outcome|Placebo Arm|"Placebo (vit C) given 1-2 hours prior to surgical abortion~Placebos: Preoperative treatment with Placebo"
11347529|NCT04292171|EG000|Reported Event|Gabapentin Arm|"Gabapentin 600 mg given 1-2 hours prior to surgical abortion~Gabapentin: Preoperative treatment with Gabapentin"
11347530|NCT04292171|EG001|Reported Event|Placebo Arm|"Placebo (vit C) given 1-2 hours prior to surgical abortion~Placebos: Preoperative treatment with Placebo"
11347531|NCT04292899|BG000|Baseline|Part A: Remdesivir (RDV) for 5 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
11347532|NCT04292899|BG001|Baseline|Part A: Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347533|NCT04292899|BG002|Baseline|Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)|Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347534|NCT04292899|BG003|Baseline|Part B: Remdesivir for 10 Days (Extension Group)|Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347535|NCT04292899|BG004|Baseline|Total|Total of all reporting groups
11347536|NCT04292899|FG000|Participant Flow|Part A: Remdesivir (RDV) for 5 Days|Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
11347537|NCT04292899|FG001|Participant Flow|Part A: Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347538|NCT04292899|FG002|Participant Flow|Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)|Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347539|NCT04292899|FG003|Participant Flow|Part B: Remdesivir for 10 Days (Extension Group)|Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347540|NCT04292899|OG000|Outcome|Part A: Remdesivir (RDV) for 5 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
11347541|NCT04292899|OG001|Outcome|Part A: Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347542|NCT04292899|EG000|Reported Event|Part A: Remdesivir (RDV) for 5 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
11347543|NCT04292899|EG001|Reported Event|Part A: Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347544|NCT04292899|EG002|Reported Event|Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)|Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347545|NCT04292899|EG003|Reported Event|Part B: Remdesivir for 10 Days (Extension Group)|Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347546|NCT04292730|BG000|Baseline|Part A: Remdesivir for 5 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
11347547|NCT04292730|BG001|Baseline|Part A: Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347548|NCT04292730|BG002|Baseline|Part A: SOC Therapy|Participants received continued SOC therapy.
11347549|NCT04292730|BG003|Baseline|Part B: Extension Treatment, Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347550|NCT04292730|BG004|Baseline|Total|Total of all reporting groups
11347551|NCT04292730|FG000|Participant Flow|Part A: Remdesivir (RDV) for 5 Days|Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
11347552|NCT04292730|FG001|Participant Flow|Part A: Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347553|NCT04292730|FG002|Participant Flow|Part A: SOC Therapy|Participants received continued SOC therapy.
11347554|NCT04292730|FG003|Participant Flow|Part B: Extension Treatment, Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347555|NCT04292730|OG000|Outcome|Part A: Remdesivir for 5 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
11347556|NCT04292730|OG001|Outcome|Part A: Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347557|NCT04292730|OG002|Outcome|Part A: SOC Therapy|Participants received continued SOC therapy.
11347558|NCT04292730|EG000|Reported Event|Part A: Remdesivir for 5 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
11347559|NCT04292730|EG001|Reported Event|Part A: Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347560|NCT04292730|EG002|Reported Event|Part A: SOC Therapy|Participants received continued SOC therapy.
11347561|NCT04292730|EG003|Reported Event|Part B: Extension Treatment, Remdesivir for 10 Days|Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
11347562|NCT04290676|BG000|Baseline|DEXYCU (Dexamethasone Intraocular Suspension) 9%|All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
11347563|NCT04290676|FG000|Participant Flow|DEXYCU (Dexamethasone Intraocular Suspension) 9%|All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
11347564|NCT04290676|OG000|Outcome|DEXYCU (Dexamethasone Intraocular Suspension) 9%|All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
11347565|NCT04290676|EG000|Reported Event|DEXYCU (Dexamethasone Intraocular Suspension) 9%|All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
11347566|NCT04290039|BG000|Baseline|A: Low Dose Sublingual - High Dose Sublingual - IV|Subjects assigned to treatment dosing sequence A will receive a low dose sublingually at Visit 1; Day 1 (Period 1), a high dose sublingually at Visit 2; Day 8 (Period 2) and an IV dose at Visit 3; Day 15 (Period 3).
11347567|NCT04290039|BG001|Baseline|B: High Dose Sublingual - IV - Low Dose Sublingual|Subjects assigned to treatment dosing sequence B will receive a high dose sublingually at Visit 1; Day 1 (Period 1), an IV dose at Visit 2; Day 8 (Period 2) and a low dose sublingually at Visit 3; Day 15 (Period 3).
11347568|NCT04290039|BG002|Baseline|C: Intravenous (IV)-Low Dose Sublingual-High Dose Sublingual|Subjects assigned to treatment dosing sequence C will receive an IV dose at Visit 1; Day 1 (Period 1), a low dose sublingually at Visit 2; Day 8 (Period 2), and a high dose sublingually at Visit 3; Day 15 (Period 3).
11347569|NCT04290039|BG003|Baseline|Total|Total of all reporting groups
10976750|NCT00942162|OG003|Outcome|GSK2132231A GS-unknown Group|Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10976751|NCT00942162|EG000|Reported Event|Overall Study Group|Group of all patients (GS+, GS- and Unknown GS) planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles.
10976752|NCT00942175|BG000|Baseline|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
10976753|NCT00942175|BG001|Baseline|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
10976754|NCT00942175|BG002|Baseline|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
10976755|NCT00942175|BG003|Baseline|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
10976756|NCT00942175|BG004|Baseline|Total|Total of all reporting groups
10976757|NCT00942175|FG000|Participant Flow|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
10976758|NCT00942175|FG001|Participant Flow|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
10976759|NCT00942175|FG002|Participant Flow|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
10976760|NCT00942175|FG003|Participant Flow|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
10976761|NCT00942175|OG000|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
10976762|NCT00942175|OG001|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
10976763|NCT00942175|OG002|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
10976764|NCT00942175|OG003|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
10976765|NCT00942175|OG004|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
10976766|NCT00942175|OG005|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
10976767|NCT00942175|OG006|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
10976768|NCT00942175|OG007|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
10976769|NCT00942175|EG000|Reported Event|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
10976770|NCT00942175|EG001|Reported Event|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
10976771|NCT00942175|EG002|Reported Event|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
10976772|NCT00942175|EG003|Reported Event|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
10976773|NCT00942175|EG004|Reported Event|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
10976774|NCT00942175|EG005|Reported Event|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
10976775|NCT00942175|EG006|Reported Event|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
10976776|NCT00942175|EG007|Reported Event|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
11223000|NCT02350309|FG003|Participant Flow|Lemborexant 10 mg, Lemborexant 5 mg, Placebo, Flurazepam 30 mg|Participants received a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
10845442|NCT00267046|EG001|Reported Event|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
10976777|NCT00942188|BG000|Baseline|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
10976778|NCT00942188|BG001|Baseline|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
10976779|NCT00942188|BG002|Baseline|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
10976780|NCT00942188|BG003|Baseline|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
10845443|NCT00267059|BG000|Baseline|Lenalidomide|10 mg/day, orally once a day for 28 days
10845444|NCT00267059|FG000|Participant Flow|Lenalidomide|10 mg/day, orally once a day for 28 days
10976781|NCT00942188|BG004|Baseline|Total|Total of all reporting groups
10976782|NCT00942188|FG000|Participant Flow|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
10976783|NCT00942188|FG001|Participant Flow|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
10976784|NCT00942188|FG002|Participant Flow|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
10976785|NCT00942188|FG003|Participant Flow|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
10976786|NCT00942188|OG000|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
10976787|NCT00942188|OG001|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
10976788|NCT00942188|OG002|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
10976789|NCT00942188|OG003|Outcome|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
10976790|NCT00942188|EG000|Reported Event|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
10976791|NCT00942188|EG001|Reported Event|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
10976792|NCT00942188|EG002|Reported Event|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
10976793|NCT00942188|EG003|Reported Event|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
10976794|NCT00942266|BG000|Baseline|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
10845445|NCT00267059|OG000|Outcome|Lenalidomide|10 mg/day, orally once a day for 28 days
10845446|NCT00267059|EG000|Reported Event|Lenalidomide|10 mg/day, orally once a day for 28 days
10976795|NCT00942266|BG001|Baseline|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
10845447|NCT00267085|BG000|Baseline|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
10976796|NCT00942266|BG002|Baseline|Total|Total of all reporting groups
10976797|NCT00942266|FG000|Participant Flow|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
10976798|NCT00942266|FG001|Participant Flow|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
11347570|NCT04290039|FG000|Participant Flow|Sequence A: Low Dose Sublingual - High Dose Sublingual - IV|Subjects assigned to treatment dosing sequence A will receive a low dose sublingually at Visit 1; Day 1 (Period 1), a high dose sublingually at Visit 2; Day 8 (Period 2) and an IV dose at Visit 3; Day 15 (Period 3).
11347571|NCT04290039|FG001|Participant Flow|Sequence B: High Dose Sublingual - IV - Low Dose Sublingual|Subjects assigned to treatment dosing sequence B will receive a high dose sublingually at Visit 1; Day 1 (Period 1), an IV dose at Visit 2; Day 8 (Period 2) and a low dose sublingually at Visit 3; Day 15 (Period 3).
11347572|NCT04290039|FG002|Participant Flow|Sequence C: IV - Low Dose Sublingual - High Dose Sublingual|Subjects assigned to treatment dosing sequence C will receive an IV dose at Visit 1; Day 1 (Period 1), a low dose sublingually at Visit 2; Day 8 (Period 2), and a high dose sublingually at Visit 3; Day 15 (Period 3).
11347573|NCT04290039|OG000|Outcome|Low Dose Sublingual|Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anti-muscarinic indicated for cyclopegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains active ingredient: atropine sulfate 10 mg equivalent to 8.3 mg of atropine.
11347574|NCT04290039|OG001|Outcome|High Dose Sublingual|Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anti-muscarinic indicated for cyclopegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains active ingredient: atropine sulfate 10 mg equivalent to 8.3 mg of atropine.
11347575|NCT04290039|OG002|Outcome|Intravenous|Atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.
11347576|NCT04290039|OG002|Outcome|Intravenous (IV)|Atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.
11347577|NCT04290039|EG000|Reported Event|Low Dose Sublingual|Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anti-muscarinic indicated for cyclopegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains active ingredient: atropine sulfate 10 mg equivalent to 8.3 mg of atropine.
11347578|NCT04290039|EG001|Reported Event|High Dose Sublingual|Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anti-muscarinic indicated for cyclopegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains active ingredient: atropine sulfate 10 mg equivalent to 8.3 mg of atropine.
11347579|NCT04290039|EG002|Reported Event|Intravenous|Atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.
11347580|NCT04289623|BG000|Baseline|Standard Email|This email mentions the cost-saving benefits of enrollment by participants who met their 2018 goals. It also includes the message that registration can be completed quickly (in less than five minutes). Finally, it also includes reward incentive information, wherein registering by a March deadline provides qualified recipients with the potential to win prizes. This information is contained in all other emails.
11347581|NCT04289623|BG001|Baseline|Loss Frame Email|"In addition to the content of the generic email, the subject line and content of the loss frame email recommends that GHP members not throw away a precise dollar amount in savings (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action. This email further frames the reward as something recipients will miss out on if they do not sign up."
11347582|NCT04289623|BG002|Baseline|Testimonial (Medical Expert) Email|In addition to the content of the generic email, the testimonial (medical expert) email includes a testimonial from a doctor, which notes the personal benefits of myHealth Rewards in terms of managing blood pressure, blood sugar, cholesterol, weight, and stress.
11347583|NCT04289623|BG003|Baseline|Testimonial (Rank-and-file) Email|In addition to the content of the generic email, the testimonial (rank-and-file) email includes a testimonial from a customer care specialist, which notes the personal benefits of myHealth Rewards in terms of managing blood pressure, blood sugar, cholesterol, weight, and stress.
11347584|NCT04289623|BG004|Baseline|Social Norms (Percentage) Email|In addition to the content of the generic email, the social norms (percentage) email will include communication about the percentage of benefit-eligible employees who had already registered for myHealth Rewards.
11347585|NCT04289623|BG005|Baseline|Social Norms (Number) Email|In addition to the content of the generic email, the social norms (number) email will include communication about the number of benefit-eligible employees who had already registered for myHealth Rewards.
11347586|NCT04289623|BG006|Baseline|Total|Total of all reporting groups
11347587|NCT04289623|FG000|Participant Flow|Standard Email|This email mentions the cost-saving benefits of enrollment by participants who met their 2018 goals. It also includes the message that registration can be completed quickly (in less than five minutes). Finally, it also includes reward incentive information, wherein registering by a March deadline provides qualified recipients with the potential to win prizes. This information is contained in all other emails.
11347588|NCT04289623|FG001|Participant Flow|Loss Frame Email|"In addition to the content of the generic email, the subject line and content of the loss frame email recommends that GHP members not throw away a precise dollar amount in savings (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action. This email further frames the reward as something recipients will miss out on if they do not sign up."
10845448|NCT00267085|FG000|Participant Flow|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
10845449|NCT00267085|OG000|Outcome|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
10976799|NCT00942266|OG000|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
10845450|NCT00267085|EG000|Reported Event|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
10845451|NCT00267098|BG000|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
10976800|NCT00942266|OG001|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
11347589|NCT04289623|FG002|Participant Flow|Testimonial (Medical Expert) Email|In addition to the content of the generic email, the testimonial (medical expert) email includes a testimonial from a doctor, which notes the personal benefits of myHealth Rewards in terms of managing blood pressure, blood sugar, cholesterol, weight, and stress.
11347590|NCT04289623|FG003|Participant Flow|Testimonial (Rank-and-file) Email|In addition to the content of the generic email, the testimonial (rank-and-file) email includes a testimonial from a customer care specialist, which notes the personal benefits of myHealth Rewards in terms of managing blood pressure, blood sugar, cholesterol, weight, and stress.
11347591|NCT04289623|FG004|Participant Flow|Social Norms (Percentage) Email|In addition to the content of the generic email, the social norms (percentage) email will include communication about the percentage of benefit-eligible employees who had already registered for myHealth Rewards.
11347592|NCT04289623|FG005|Participant Flow|Social Norms (Number) Email|In addition to the content of the generic email, the social norms (number) email will include communication about the number of benefit-eligible employees who had already registered for myHealth Rewards.
11347593|NCT04289623|OG000|Outcome|Standard Email|This email mentions the cost-saving benefits of enrollment by participants who met their 2018 goals. It also includes the message that registration can be completed quickly (in less than five minutes). Finally, it also includes reward incentive information, wherein registering by a March deadline provides qualified recipients with the potential to win prizes. This information is contained in all other emails.
11347594|NCT04289623|OG001|Outcome|Loss Frame Email|"In addition to the content of the generic email, the subject line and content of the loss frame email recommends that GHP members not throw away a precise dollar amount in savings (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action. This email further frames the reward as something recipients will miss out on if they do not sign up."
11347595|NCT04289623|OG002|Outcome|Testimonial (Medical Expert) Email|In addition to the content of the generic email, the testimonial (medical expert) email includes a testimonial from a doctor, which notes the personal benefits of myHealth Rewards in terms of managing blood pressure, blood sugar, cholesterol, weight, and stress.
11347596|NCT04289623|OG003|Outcome|Testimonial (Rank-and-file) Email|In addition to the content of the generic email, the testimonial (rank-and-file) email includes a testimonial from a customer care specialist, which notes the personal benefits of myHealth Rewards in terms of managing blood pressure, blood sugar, cholesterol, weight, and stress.
11347597|NCT04289623|OG004|Outcome|Social Norms (Percentage) Email|In addition to the content of the generic email, the social norms (percentage) email will include communication about the percentage of benefit-eligible employees who had already registered for myHealth Rewards.
11347598|NCT04289623|OG005|Outcome|Social Norms (Number) Email|In addition to the content of the generic email, the social norms (number) email will include communication about the number of benefit-eligible employees who had already registered for myHealth Rewards.
11347599|NCT04289623|EG000|Reported Event|Standard Email|This email mentions the cost-saving benefits of enrollment by participants who met their 2018 goals. It also includes the message that registration can be completed quickly (in less than five minutes). Finally, it also includes reward incentive information, wherein registering by a March deadline provides qualified recipients with the potential to win prizes. This information is contained in all other emails.
11347600|NCT04289623|EG001|Reported Event|Loss Frame Email|"In addition to the content of the generic email, the subject line and content of the loss frame email recommends that GHP members not throw away a precise dollar amount in savings (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action. This email further frames the reward as something recipients will miss out on if they do not sign up."
11347601|NCT04289623|EG002|Reported Event|Testimonial (Medical Expert) Email|In addition to the content of the generic email, the testimonial (medical expert) email includes a testimonial from a doctor, which notes the personal benefits of myHealth Rewards in terms of managing blood pressure, blood sugar, cholesterol, weight, and stress.
11347602|NCT04289623|EG003|Reported Event|Testimonial (Rank-and-file) Email|In addition to the content of the generic email, the testimonial (rank-and-file) email includes a testimonial from a customer care specialist, which notes the personal benefits of myHealth Rewards in terms of managing blood pressure, blood sugar, cholesterol, weight, and stress.
11347603|NCT04289623|EG004|Reported Event|Social Norms (Percentage) Email|In addition to the content of the generic email, the social norms (percentage) email will include communication about the percentage of benefit-eligible employees who had already registered for myHealth Rewards.
11347604|NCT04289623|EG005|Reported Event|Social Norms (Number) Email|In addition to the content of the generic email, the social norms (number) email will include communication about the number of benefit-eligible employees who had already registered for myHealth Rewards.
11347605|NCT04276207|BG000|Baseline|100 U/mL LY900014 and 100 U/mL Insulin Lispro (Humalog)|"Participants received 100 U/mL LY900014 administered by CSII in one of two study periods.~Participants received 100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods."
11347606|NCT04276207|FG000|Participant Flow|Sequence AB (LY900014, Insulin Lispro (Humalog))|"Period 1:~Participants received 100 units per milliliter (U/mL) of LY900014 administered by continuous subcutaneous insulin infusion (CSII).~Period 2:~Participants received 100 U/mL of Insulin lispro Humalog) administered by CSII."
11347607|NCT04276207|FG001|Participant Flow|Sequence BA (Insulin Lispro (Humalog), LY900014))|"Period 1:~Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII.~Period 2:~Participants received 100 U/mL of LY900014 administered by CSII."
11347608|NCT04276207|OG000|Outcome|100 U/mL LY900014|Participants received 100 U/mL of LY900014 administered by CSII in one of the two study periods.
11347609|NCT04276207|OG001|Outcome|100 U/mL Insulin Lispro (Humalog)|Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
10976801|NCT00942266|EG000|Reported Event|Arm I|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
10976802|NCT00942266|EG001|Reported Event|Arm II|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
10976803|NCT00942305|BG000|Baseline|Cohort 1 BCV|40 mg brincidofovir (BCV) administered once weekly (QW)
10976804|NCT00942305|BG001|Baseline|Cohort 1 Placebo|Placebo administered once weekly (QW)
10976805|NCT00942305|BG002|Baseline|Cohort 2 BCV|100 mg brincidofovir (BCV) administered once weekly (QW)
10976806|NCT00942305|BG003|Baseline|Cohort 2 Placebo|Placebo administered once weekly (QW)
10976807|NCT00942305|BG004|Baseline|Cohort 3 BCV|200 mg brincidofovir (BCV) administered once weekly (QW)
10976808|NCT00942305|BG005|Baseline|Cohort 3 Placebo|Placebo administered once weekly (QW)
11347610|NCT04276207|EG000|Reported Event|100 U/mL LY900014|Participants received 100 U/mL of LY900014 administered by CSII in one of the two study periods.
11347611|NCT04276207|EG001|Reported Event|100 U/mL Insulin Lispro (Humalog)|Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
11347612|NCT04289714|BG000|Baseline|R-DOT|"Remote Directly Observed Therapy~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347613|NCT04289714|BG001|Baseline|Haillie|"Smartinhaler Haillie~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347614|NCT04289714|BG002|Baseline|Rafi-tone/INCA|"Rafi-tone with Flo-tone /INCA~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347615|NCT04289714|BG003|Baseline|Total|Total of all reporting groups
11347616|NCT04289714|FG000|Participant Flow|R-DOT|"Remote Directly Observed Therapy~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347617|NCT04289714|FG001|Participant Flow|Haillie|"Smartinhaler Haillie~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347618|NCT04289714|FG002|Participant Flow|Rafi-tone/INCA|"Rafi-tone with Flo-tone /INCA~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347619|NCT04289714|OG000|Outcome|R-DOT|Remote Directly Observed Therapy
11347620|NCT04289714|OG001|Outcome|Haillie|Smartinhaler Haillie
11347621|NCT04289714|OG002|Outcome|Rafi-tone/INCA|Rafi-tone with Flo-tone /INCA
11347622|NCT04289714|EG000|Reported Event|R-DOT|"Remote Directly Observed Therapy~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347623|NCT04289714|EG001|Reported Event|Haillie|"Smartinhaler Haillie~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347624|NCT04289714|EG002|Reported Event|Rafi-tone/INCA|"Rafi-tone with Flo-tone /INCA~Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled"
11347625|NCT04288752|BG000|Baseline|VR101 Lubricating Intravaginal Ring|"VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.~VR101 Lubricating Intravaginal Ring: VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication."
11347626|NCT04288752|BG001|Baseline|Sham Ring|"Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.~Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.~Sham Ring: Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added."
11347627|NCT04288752|BG002|Baseline|Total|Total of all reporting groups
11347628|NCT04288752|FG000|Participant Flow|VR101 Lubricating Intravaginal Ring|"VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.~VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication."
11347629|NCT04288752|FG001|Participant Flow|Sham Ring|"Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.~Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added."
11347630|NCT04288752|OG000|Outcome|VR101 Lubricating Intravaginal Ring|"VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.~VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication."
10976809|NCT00942305|BG006|Baseline|Cohort 4 BCV|"200 mg brincidofovir (BCV) administered twice weekly (BIW)~Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose."
10976810|NCT00942305|BG007|Baseline|Cohort 4 Placebo|Placebo administered twice weekly (BIW)
10845452|NCT00267098|BG001|Baseline|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
10845453|NCT00267098|BG002|Baseline|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
10976811|NCT00942305|BG008|Baseline|Cohort 4a BCV|100 mg brincidofovir (BCV) administered twice weekly (BIW)
10976812|NCT00942305|BG009|Baseline|Cohort 4a Placebo|Placebo administered twice weekly (BIW)
10976813|NCT00942305|BG010|Baseline|Total|Total of all reporting groups
10976814|NCT00942305|FG000|Participant Flow|Cohort 1 BCV|40 mg brincidofovir (BCV) administered once weekly
10976815|NCT00942305|FG001|Participant Flow|Cohort 1 Placebo|Placebo administered once weekly (QW)
10976816|NCT00942305|FG002|Participant Flow|Cohort 2 BCV|100 mg brincidofovir (BCV) administered once weekly
10976817|NCT00942305|FG003|Participant Flow|Cohort 2 Placebo|Placebo administered once weekly (QW)
10976818|NCT00942305|FG004|Participant Flow|Cohort 3 BCV|200 mg brincidofovir (BCV) administered once weekly
10976819|NCT00942305|FG005|Participant Flow|Cohort 3 Placebo|Placebo administered once weekly (QW)
10976820|NCT00942305|FG006|Participant Flow|Cohort 4 BCV|"200 mg brincidofovir (BCV) administered twice weekly (BIW)~Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose."
10976821|NCT00942305|FG007|Participant Flow|Cohort 4 Placebo|Placebo administered twice weekly (BIW)
10976822|NCT00942305|FG008|Participant Flow|Cohort 4a|100 mg brincidofovir (BCV) administered twice weekly (BIW)
10976823|NCT00942305|FG009|Participant Flow|Cohort 4a Placebo|Placebo administered twice weekly (BIW)
10976824|NCT00942305|OG000|Outcome|Cohort 1 BCV|40 mg brincidofovir (BCV) administered once weekly (QW)
10976825|NCT00942305|OG001|Outcome|Cohort 1 Placebo|Placebo administered once weekly (QW)
10845454|NCT00267098|BG003|Baseline|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
10976826|NCT00942305|OG002|Outcome|Cohort 2 BCV|100 mg brincidofovir (BCV) administered once weekly (QW)
10845455|NCT00267098|BG004|Baseline|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
10845456|NCT00267098|BG005|Baseline|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
10976827|NCT00942305|OG003|Outcome|Cohort 2 Placebo|Placebo administered once weekly (QW)
10976828|NCT00942305|OG004|Outcome|Cohort 3 BCV|200 mg brincidofovir (BCV) administered once weekly (QW)
10976829|NCT00942305|OG005|Outcome|Cohort 3 Placebo|Placebo administered once weekly (QW)
10845457|NCT00267098|BG006|Baseline|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
10845458|NCT00267098|BG007|Baseline|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
10845459|NCT00267098|BG008|Baseline|Total|Total of all reporting groups
10976830|NCT00942305|OG006|Outcome|Cohort 4 BCV|"200 mg brincidofovir (BCV) administered twice weekly (BIW)~Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose."
10976831|NCT00942305|OG007|Outcome|Cohort 4 Placebo|Placebo administered twice weekly (BIW)
10845460|NCT00267098|FG000|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
10976832|NCT00942305|OG008|Outcome|Cohort 4a BCV|100 mg brincidofovir (BCV) administered twice weekly (BIW)
10976833|NCT00942305|OG009|Outcome|Cohort 4a Placebo|Placebo administered twice weekly (BIW)
10976834|NCT00942305|EG000|Reported Event|Cohort 1 BCV|40 mg brincidofovir (BCV) administered once weekly (QW)
10976835|NCT00942305|EG001|Reported Event|Cohort 1 Placebo|Placebo administered once weekly (QW)
10976836|NCT00942305|EG002|Reported Event|Cohort 2 BCV|100 mg brincidofovir (BCV) administered once weekly (QW)
10976837|NCT00942305|EG003|Reported Event|Cohort 2 Placebo|Placebo administered once weekly (QW)
10976838|NCT00942305|EG004|Reported Event|Cohort 3 BCV|200 mg brincidofovir (BCV) administered once weekly (QW)
10976839|NCT00942305|EG005|Reported Event|Cohort 3 Placebo|Placebo administered once weekly (QW)
11347631|NCT04288752|OG001|Outcome|Sham Ring|"Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.~Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added."
11347632|NCT04288752|EG000|Reported Event|VR101 Lubricating Intravaginal Ring|"VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.~VR101 Lubricating Intravaginal Ring: VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication."
11347633|NCT04288752|EG001|Reported Event|Sham Ring|"Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.~Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.~Sham Ring: Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added."
11347634|NCT04287517|BG000|Baseline|Capacitive-Resistive Therapy Group|"This group was treated with capacitive resistive diathermy and exercise~Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves."
11347635|NCT04287517|BG001|Baseline|Sham Group|"This group was treated with sham capacitive-resistive diathermy and exercise~Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves."
11347636|NCT04287517|BG002|Baseline|Total|Total of all reporting groups
11347637|NCT04287517|FG000|Participant Flow|Capacitive-Resistive Therapy Group|"This group was treated with capacitive resistive diathermy and exercise~Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves."
11347638|NCT04287517|FG001|Participant Flow|Sham Group|"This group was treated with sham capacitive-resistive diathermy and exercise~Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves."
11347639|NCT04287517|OG000|Outcome|Capacitive-Resistive Therapy Group|"This group was treated with capacitive resistive diathermy and exercise~Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves."
11347640|NCT04287517|OG001|Outcome|Sham Group|"This group was treated with sham capacitive-resistive diathermy and exercise~Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves."
11347641|NCT04287517|EG000|Reported Event|Capacitive-Resistive Therapy Group|"This group was treated with capacitive resistive diathermy and exercise~Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves."
11347642|NCT04287517|EG001|Reported Event|Sham Group|"This group was treated with sham capacitive-resistive diathermy and exercise~Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves."
11347643|NCT04287036|BG000|Baseline|All Subjects|All subjects who were dispensed a study lens.
11347644|NCT04287036|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.
11347645|NCT04287036|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.
11347646|NCT04287036|OG000|Outcome|Test|Subjects that wore the Test lens in either the first or second period of the study.
11347647|NCT04287036|OG001|Outcome|Control|Subjects that wore the Control lens in either the first or second period of the study.
11347648|NCT04287036|EG000|Reported Event|Test|Subjects that wore the Test lens in either the first or second period of the study.
11347649|NCT04287036|EG001|Reported Event|Control|Subjects that wore the Control lens in either the first or second period of the study.
11347650|NCT04286412|BG000|Baseline|Nonacog Alfa|Participants received nonacog alfa IV injection as follows: Prophylactic treatment regimen: at a dose of 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days in accordance with the LPD guidelines until at least 16 exposure days or a period of up to 8 weeks on nonacog alfa treatment had occurred (whichever occurred first). For OD treatment (infusions used to treat bleeding episodes) regimen nonacog alfa was administered at individual doses and frequency depending on the clinical effectiveness (clinical effectiveness refers to the efficacy of nonacog alfa) in individual participants as recommended in approved LPD.
10845461|NCT00267098|FG001|Participant Flow|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
10845462|NCT00267098|FG002|Participant Flow|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
11347651|NCT04286412|FG000|Participant Flow|Nonacog Alfa|Participants received nonacog alfa intravenous (IV) injection as follows: Prophylactic treatment regimen: at a dose of 40 international unit per kilogram (IU/kg) (range 13 to 78 IU/kg) at intervals of 3 to 4 days in accordance with the local product document (LPD) guidelines until at least 16 exposure days or a period of up to 8 weeks on nonacog alfa treatment had occurred (whichever occurred first). For on demand (OD) treatment (infusions used to treat bleeding episodes) regimen nonacog alfa was administered at individual doses and frequency depending on the clinical effectiveness (clinical effectiveness refers to the efficacy of nonacog alfa) in individual participants as recommended in approved LPD.
11347652|NCT04286412|OG000|Outcome|Nonacog Alfa|Participants received nonacog alfa IV injection as follows: Prophylactic treatment regimen: at a dose of 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days in accordance with the LPD guidelines until at least 16 exposure days or a period of up to 8 weeks on nonacog alfa treatment had occurred (whichever occurred first). For OD treatment (infusions used to treat bleeding episodes) regimen nonacog alfa was administered at individual doses and frequency depending on the clinical effectiveness (clinical effectiveness refers to the efficacy of nonacog alfa) in individual participants as recommended in approved LPD.
11347653|NCT04286412|EG000|Reported Event|Nonacog Alfa|Participants received nonacog alfa IV injection as follows: Prophylactic treatment regimen: at a dose of 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days in accordance with the LPD guidelines until at least 16 exposure days or a period of up to 8 weeks on nonacog alfa treatment had occurred (whichever occurred first). For OD treatment (infusions used to treat bleeding episodes) regimen nonacog alfa was administered at individual doses and frequency depending on the clinical effectiveness (clinical effectiveness refers to the efficacy of nonacog alfa) in individual participants as recommended in approved LPD.
11347654|NCT04285411|BG000|Baseline|ARMS SpO2 70-100%|"Comparison to Reference CO-Oximetry~Accuracy of the VitalDetect™ pulse oximetry system: The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less."
11347655|NCT04285411|FG000|Participant Flow|ARMS SpO2 70-100%|"Comparison to Reference CO-Oximetry~Accuracy of the VitalDetect™ pulse oximetry system: The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less."
11347656|NCT04285411|OG000|Outcome|ARMS SpO2 70-100%|Comparison to Reference CO-Oximetry
11347657|NCT04285411|OG000|Outcome|ARMS SpO2 70-100%|Compared to ECG Heart Rate.
11347658|NCT04285411|EG000|Reported Event|ARMS SpO2 70-100%|"Comparison to Reference CO-Oximetry~Accuracy of the VitalDetect™ pulse oximetry system: The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.~No Adverse events reported"
11347659|NCT04284930|BG000|Baseline|Depobupivacaine|"Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.~Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia."
11347660|NCT04284930|BG001|Baseline|OnQ Pump|"Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.~OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure."
11347661|NCT04284930|BG002|Baseline|Bupivacaine|"Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.~0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle."
11347662|NCT04284930|BG003|Baseline|Total|Total of all reporting groups
11347663|NCT04284930|FG000|Participant Flow|Depobupivacaine|"Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.~Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia."
11347664|NCT04284930|FG001|Participant Flow|OnQ Pump|"Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.~OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure."
11347665|NCT04284930|FG002|Participant Flow|Bupivacaine|"Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.~0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle."
11347666|NCT04284930|OG000|Outcome|Depobupivacaine|"Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.~Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia."
11347667|NCT04284930|OG001|Outcome|OnQ Pump|"Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.~OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure."
11347668|NCT04284930|OG002|Outcome|Bupivacaine|"Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.~0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle."
11347669|NCT04284930|EG000|Reported Event|Depobupivacaine|"Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.~Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia."
11347670|NCT04284930|EG001|Reported Event|OnQ Pump|"Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.~OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure."
11347671|NCT04284930|EG002|Reported Event|Bupivacaine|"Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.~0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle."
11347672|NCT04283773|BG000|Baseline|Malignant Ovarian Germ Cell Tumors ( MOGCTs).|"22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody .~p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267)."
11347673|NCT04283773|BG001|Baseline|Mature Cystic Teratomas.|20 cases of mature teratomas will be treated by anti P16 antibody .
11347674|NCT04283773|BG002|Baseline|Normally Apparent Ovaries.|20cases of normally apparent ovaries will be treated by anti P16 antibody .
11347675|NCT04283773|BG003|Baseline|Total|Total of all reporting groups
11347676|NCT04283773|FG000|Participant Flow|IHC of P16 Expression in Malignant Ovarian Germ Cell Tumors.|22 cases of malignant ovarian germ cell tumors ; 5cases of dysgerminoma ( one of them is bilateral) , 9 cases of yolk sac tumor and 8 cases of immature teratoma. These cases are treated by anti P16 antibody( p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) , 1:500 concentration, over night duration and then treated by DAP secondary antibody . Finally assessed by visualized peroxidase method. and also treated by Ki67 antibody.
11347677|NCT04283773|FG001|Participant Flow|IHC of P16 Expression in Benign Ovarian Germ Cell Tumors ( Mature Cystic Teratomas).|20 cases of benign ovarian germ cell tumors ( Mature cystic teratomas). These cases are treated by anti P16 antibody( p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) , 1:500 concentration, over night duration and then treated by DAP secondary antibody.
11347678|NCT04283773|FG002|Participant Flow|IHC of P16 Expression in Normal Ovarian Tissues.|20 normal ovarian tissue specimens are used as controls. These cases are treated by anti P16 antibody( p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) , 1:500 concentration, over night duration and then treated by DAP secondary antibody.
11347679|NCT04283773|OG000|Outcome|Malignant Ovarian Germ Cell Tumors ( MOGCTs).|"22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody and Ki67 antibody.~p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody."
11347680|NCT04283773|OG001|Outcome|Mature Cystic Teratomas.|"20 cases of mature teratomas will be treated by anti P16 antibody .~p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody."
11347681|NCT04283773|OG002|Outcome|Normally Apparent Ovaries.|"20 cases of normally apparent ovaries will be treated by anti P16 antibody .~p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody."
11347682|NCT04283773|OG000|Outcome|Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.|"22 cases of malignant ovarian germ cell tumors ; 5cases of dysgerminoma ( one of them is bilateral) , 9 cases of yolk sac tumor and 8 cases of immature teratoma.~For KI67 IHC staining for malignant cases, percentage of nuclear positivity stained cells were assessed. KI67 LI is estimated by percentage of positive nuclei to all tumor cells from 0 to 100% scale."
11347683|NCT04283773|OG000|Outcome|Malignant Ovarian Germ Cell Tumors ( MOGCTs).|22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody
11347684|NCT04283773|EG000|Reported Event|Immunohistochemical Expression of P16 Expression in Malignant Ovarian Germ Cell Tumors.|22cases of malignant ovarian germ cell tumors ; 5 cases of dysgerminoma ( one of them is bilateral) , 9cases of yolk sac tumor and 8 cases of immature teratoma. These cases are treated by anti P16 antibody( p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) , 1:500 concentration, over night duration and then treated by DAP secondary antibody . Finally assessed by visualized peroxidase method.
11347685|NCT04283773|EG001|Reported Event|Immunohistochemical Expression of P16 Expression in Benign Ovarian Germ Cell (MCTs)|20 cases of mature cystic teratomas ; were treated by anti P16 antibody( p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) , 1:500 concentration, over night duration and then treated by DAP secondary antibody . Finally assessed by visualized peroxidase method.
11347686|NCT04283773|EG002|Reported Event|Immunohistochemical Expression of P16 Expression in Normal Ovarian Tissues.|20 cases of normal ovarian tissues were treated by anti P16 antibody( p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) , 1:500 concentration, over night duration and then treated by DAP secondary antibody . Finally assessed by visualized peroxidase method.
11347687|NCT04281901|BG000|Baseline|PVRP Treated Participants|"Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied~Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma"
11347688|NCT04281901|BG001|Baseline|Standardly Treated Participants|"Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.~Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity."
11347689|NCT04281901|BG002|Baseline|Total|Total of all reporting groups
10845463|NCT00267098|FG003|Participant Flow|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
11223001|NCT02350309|FG004|Participant Flow|Lemborexant 5 mg, Placebo, Lemborexant 10 mg, Flurazepam 30 mg|Participants received a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
10976840|NCT00942305|EG006|Reported Event|Cohort 4 BCV|"200 mg brincidofovir (BCV) administered twice weekly (BIW)~Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose."
10976841|NCT00942305|EG007|Reported Event|Cohort 4 Placebo|Placebo administered twice weekly (BIW)
10976842|NCT00942305|EG008|Reported Event|Cohort 4a BCV|100 mg brincidofovir (BCV) administered twice weekly (BIW)
10976843|NCT00942305|EG009|Reported Event|Cohort 4a Placebo|Placebo administered twice weekly (BIW)
11347690|NCT04281901|FG000|Participant Flow|PVRP Treated Participants|"Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied~Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma"
11347691|NCT04281901|FG001|Participant Flow|Standardly Treated Participants|"Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.~Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity."
11347692|NCT04281901|OG000|Outcome|PVRP Treated Participants|"Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied~Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma"
11347693|NCT04281901|OG001|Outcome|Standardly Treated Participants|"Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.~Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity."
11347694|NCT04281901|EG000|Reported Event|PVRP Treated Participants|"Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied~Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma"
11347695|NCT04281901|EG001|Reported Event|Standardly Treated Participants|"Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.~Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity."
11347696|NCT04280653|BG000|Baseline|NDE L68 StableFit® Punctal Plug|"Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion~NDE L68 StableFit® Punctal Plug: Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion."
11347697|NCT04280653|FG000|Participant Flow|NDE L68 StableFit® Punctal Plug|"Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion~NDE L68 StableFit® Punctal Plug: Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion."
11347698|NCT04280653|OG000|Outcome|NDE L68 StableFit® Punctal Plug|"Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion~NDE L68 StableFit® Punctal Plug: Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion."
11347699|NCT04280653|EG000|Reported Event|NDE L68 StableFit® Punctal Plug|Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion
11347700|NCT04277936|BG000|Baseline|Levetiracetam (LEV) 500 mg|"Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.~Levetiracetam 500 mg: Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus."
11347701|NCT04277936|FG000|Participant Flow|Levetiracetam (LEV) 500 mg|"Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.~Levetiracetam 500 mg: Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus."
11347702|NCT04277936|OG000|Outcome|Levetiracetam (LEV) 500 mg|"Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.~Levetiracetam 500 mg: Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus."
11347703|NCT04277936|EG000|Reported Event|Levetiracetam (LEV) 500 mg|"Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.~Levetiracetam 500 mg: Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus."
11347704|NCT04275336|BG000|Baseline|EMLA Group|"Use EMLA cream in the management of peripheral venipuncture pain.~EMLA cream will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter."
11223002|NCT02350309|FG005|Participant Flow|Placebo, Lemborexant 10 mg, Lemborexant 5 mg, Flurazepam 30 mg|Participants received a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Period 1, followed by a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Period 2, followed by a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Period 3, followed by a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4. All doses were administered within 5 minutes before bedtime. A washout period of 12 to 16 days was maintained between the 2 treatment periods.
10845464|NCT00267098|FG004|Participant Flow|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
10855654|NCT00330421|FG001|Participant Flow|Group I (Sarcomas of Extremity)|Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator. Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at baseline and immediately before surgery.
10855655|NCT00330421|OG000|Outcome|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
10855656|NCT00330421|EG000|Reported Event|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
10855657|NCT00330460|BG000|Baseline|Alendronate 70 mg QW|
10855658|NCT00330460|BG001|Baseline|Denosumab 60 mg Q6M|
10855659|NCT00330460|BG002|Baseline|Total|Total of all reporting groups
10855660|NCT00330460|FG000|Participant Flow|Alendronate 70 mg QW|
10855661|NCT00330460|FG001|Participant Flow|Denosumab 60 mg Q6M|
10855662|NCT00330460|OG000|Outcome|Alendronate 70 mg QW|
10855663|NCT00330460|OG001|Outcome|Denosumab 60 mg Q6M|
10855664|NCT00330460|EG000|Reported Event|Alendronate 70 mg QW|
10855665|NCT00330460|EG001|Reported Event|Denosumab 60 mg Q6M|
10855666|NCT00330551|BG000|Baseline|Long-acting Injectable Risperidone|"Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management~Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.~Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.~Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed."
10855667|NCT00330551|BG001|Baseline|Oral Risperidone|"Participants taking daily oral risperidone, plus group skills training and case management~Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.~Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.~Oral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist."
10855668|NCT00330551|BG002|Baseline|Total|Total of all reporting groups
10855669|NCT00330551|FG000|Participant Flow|Long-acting Injectable Risperidone|"Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management~Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.~Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.~Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed."
10855670|NCT00330551|FG001|Participant Flow|Oral Risperidone|"Participants taking daily oral risperidone, plus group skills training and case management~Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.~Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.~Oral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist."
10855671|NCT00330551|OG000|Outcome|Long-acting Injectable Risperidone|"Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.~Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed."
10855672|NCT00330551|OG001|Outcome|Oral Risperidone|"Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months.~Oral Risperidone: Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist."
11223003|NCT02350309|OG000|Outcome|Lemborexant-matched Placebo|Participants received a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Periods 1, 2, or 3.
11223004|NCT02350309|OG001|Outcome|Lemborexant 5 mg|Participants received a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Periods 1, 2, or 3.
11223005|NCT02350309|OG002|Outcome|Lemborexant 10 mg|Participants received a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Periods 1, 2, or 3.
11223006|NCT02350309|OG003|Outcome|Flurazepam 30 mg|Participants received a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4.
11223007|NCT02350309|OG000|Outcome|Lemborexant 5 mg|Participants received a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Periods 1, 2, or 3.
10855673|NCT00330551|OG000|Outcome|Long-acting Injectable Risperidone|"Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management~Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.~Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.~Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed."
10855674|NCT00330551|OG001|Outcome|Oral Risperidone|"Participants taking daily oral risperidone, plus group skills training and case management~Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.~Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.~Oral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist."
10855675|NCT00330551|EG000|Reported Event|Long-acting Injectible Risperidone|"Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management~Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.~Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.~Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed."
10855676|NCT00330551|EG001|Reported Event|Oral Risperidone|"Participants taking daily oral risperidone, plus group skills training and case management~Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.~Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.~Oral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist."
10878889|NCT00454649|FG000|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
10878890|NCT00454649|FG001|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878891|NCT00454649|FG002|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878892|NCT00454649|FG003|Participant Flow|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
10878893|NCT00454649|FG004|Participant Flow|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878894|NCT00454649|FG005|Participant Flow|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
11126310|NCT00145158|OG000|Outcome|Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).
10878895|NCT00454649|FG006|Participant Flow|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
11223008|NCT02350309|OG001|Outcome|Lemborexant 10 mg|Participants received a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Periods 1, 2, or 3.
11223009|NCT02350309|OG002|Outcome|Flurazepam 30 mg|Participants received a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4.
11223010|NCT02350309|OG000|Outcome|Flurazepam 30 mg|Participants received a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4.
10845465|NCT00267098|FG005|Participant Flow|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
10845466|NCT00267098|FG006|Participant Flow|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
10845467|NCT00267098|FG007|Participant Flow|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
10845468|NCT00267098|OG000|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
10845469|NCT00267098|OG001|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
10845470|NCT00267098|OG000|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
10845471|NCT00267098|OG001|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
10845472|NCT00267098|OG002|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
10845473|NCT00267098|OG003|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
10845474|NCT00267098|OG000|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
10845475|NCT00267098|OG001|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
10845476|NCT00267098|OG000|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
10845477|NCT00267098|OG001|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
10845478|NCT00267098|OG000|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
10845479|NCT00267098|OG001|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
10845480|NCT00267098|OG000|Outcome|Subjects With a CRT-P Implant Attempt|Subjects who underwent an implant attempt for a CRT-P device
10845481|NCT00267098|OG001|Outcome|Subjects With a CRT-D Implant Attempt|Subjects who underwent an implant attempt for a CRT-D device
10845482|NCT00267098|OG000|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
10845483|NCT00267098|OG001|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
10845484|NCT00267098|EG000|Reported Event|Biventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive biventricular pacing
10845485|NCT00267098|EG001|Reported Event|Right Ventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive right ventricular pacing
10845486|NCT00267098|EG002|Reported Event|CRT: Not Randomized|Subjects successfully implanted with a CRT device who were not randomized
10845487|NCT00267098|EG003|Reported Event|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
10845488|NCT00267098|EG004|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
10845489|NCT00267111|BG000|Baseline|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
10845490|NCT00267111|BG001|Baseline|Placebo Group|1 g Eucerin plus was used as a placebo.
10845491|NCT00267111|BG002|Baseline|Total|Total of all reporting groups
10845492|NCT00267111|FG000|Participant Flow|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
10845493|NCT00267111|FG001|Participant Flow|Placebo Group|1 g Eucerin plus was used as a placebo.
10845494|NCT00267111|OG000|Outcome|1 g Amethocaine Gel 4%|1 g Amethocaine gel 4% was used as the active drug
10845495|NCT00267111|OG001|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
10845496|NCT00267111|OG000|Outcome|Amethocaine Gel 4% Group|1 g Amethocaine gel 4% was used as the active drug
10845497|NCT00267111|EG000|Reported Event|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
10845498|NCT00267111|EG001|Reported Event|Placebo Group|1 g Eucerin plus was used as a placebo.
10845499|NCT00267150|BG000|Baseline|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
10845500|NCT00267150|FG000|Participant Flow|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
10845501|NCT00267150|OG000|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
10845502|NCT00267150|EG000|Reported Event|All Patients|All patients
10845503|NCT00267189|BG000|Baseline|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
10845504|NCT00267189|BG001|Baseline|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
10845505|NCT00267189|BG002|Baseline|Total|Total of all reporting groups
10845506|NCT00267189|FG000|Participant Flow|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
10845507|NCT00267189|FG001|Participant Flow|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
10845508|NCT00267189|OG000|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
11223011|NCT02350309|OG000|Outcome|Lemborexant 5 or 10 mg: All Participants|Participants received a single oral dose of lemborexant 5 mg or 10 mg tablet, on Day 1 of Treatment Periods 1, 2, or 3.
11223012|NCT02350309|EG000|Reported Event|Lemborexant-matched Placebo|Participants received a single oral dose of lemborexant-matched placebo tablet, on Day 1 of Treatment Periods 1, 2, or 3.
11223013|NCT02350309|EG001|Reported Event|Lemborexant 5 mg|Participants received a single oral dose of lemborexant 5 mg tablet, on Day 1 of Treatment Periods 1, 2, or 3.
10855677|NCT00330564|BG000|Baseline|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
10855678|NCT00330564|FG000|Participant Flow|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
10855679|NCT00330564|OG000|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
10855680|NCT00330564|EG000|Reported Event|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
10855681|NCT00330616|BG000|Baseline|Bupropion SR|
10855682|NCT00330616|FG000|Participant Flow|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
10855683|NCT00330616|OG000|Outcome|Bupropion SR|
10855684|NCT00330616|EG000|Reported Event|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
10855685|NCT00330668|BG000|Baseline|All rhIGF-1 Subjects|"All subjects entering MS306 began rhIGF-1 BID treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 μg/kg BID). MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.~Following Protocol Amendment 1, the dosing regimen was changed and all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.~Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 QD, followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study."
10855686|NCT00330668|FG000|Participant Flow|All rhIGF-1 Subjects|"All subjects entering MS306 began recombinant human insulin-like growth factor-1 (rhIGF-1) twice a day (BID) treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 micrograms [μg]/ kilogram [kg] BID). MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.~Following Protocol Amendment 1, the dosing regimen was changed and all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.~Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 once a day (QD), followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study."
10855687|NCT00330668|OG000|Outcome|120 μg/kg rhIGF-1 BID (MITT Population)|Subjects in the MITT population received 120 μg/kg rhIGF-1 BID and received the same dose throughout the BID phase of the study.
10855688|NCT00330668|EG000|Reported Event|All rhIGF-1 Subjects|"All subjects entering MS306 began recombinant human insulin-like growth factor-1 (rhIGF-1) BID treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 μg/kg BID).~MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.~Following Protocol Amendment 1, all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.~Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 QD, followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study."
10855689|NCT00330681|BG000|Baseline|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
10855690|NCT00330681|BG001|Baseline|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
10855691|NCT00330681|BG002|Baseline|Total|Total of all reporting groups
10855692|NCT00330681|FG000|Participant Flow|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
10855693|NCT00330681|FG001|Participant Flow|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
10855694|NCT00330681|OG000|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
10855695|NCT00330681|OG001|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
10855696|NCT00330681|EG000|Reported Event|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
10855697|NCT00330681|EG001|Reported Event|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
11223014|NCT02350309|EG002|Reported Event|Lemborexant 10 mg|Participants received a single oral dose of lemborexant 10 mg tablet, on Day 1 of Treatment Periods 1, 2, or 3.
10855698|NCT00330733|BG000|Baseline|Placebo|Matching placebo
10855699|NCT00330733|BG001|Baseline|Salsalate Therapy|Salsalate therapy, double-masked. Salsalate (Caraco Pharmaceutical Labs, Detroit, MI, USA) was initiated at 3.0 g/day and increased at weeks 2 and 4 of the treatment period to 3.5 and 4.0 g/day, respectively, in divided doses twice daily, as tolerated for 12 weeks total.
10855700|NCT00330733|BG002|Baseline|Total|Total of all reporting groups
10855701|NCT00330733|FG000|Participant Flow|Placebo|Matching placebo
10855702|NCT00330733|FG001|Participant Flow|Salsalate|Salsalate therapy (Caraco Pharmaceutical Labs, Detroit, MI, USA) was initiated at 3.0 g/day and increased at weeks 2 and 4 of the treatment period to 3.5 and 4.0 g/day, respectively, in divided doses twice daily, as tolerated.
10855703|NCT00330733|OG000|Outcome|Placebo|Placebo: Matching placebo
10855704|NCT00330733|OG001|Outcome|Salsalate Therapy|Salsalate: Salsalate therapy
10855705|NCT00330733|EG000|Reported Event|Placebo|Placebo: Matching placebo The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred.
10855706|NCT00330733|EG001|Reported Event|Salsalate Therapy|Salsalate: Salsalate therapy The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred.
10976844|NCT00942357|BG000|Baseline|Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)|"Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Cisplatin: Given IV~Internal Radiation Therapy: Undergo brachytherapy~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy"
11223015|NCT02350309|EG003|Reported Event|Flurazepam 30 mg|Participants received a single oral dose of flurazepam 30 mg capsule on Day 1 of Treatment Period 4.
11223016|NCT02350478|BG000|Baseline|Linagliptin|"The subjects will receive Linagliptin 5mg (licensed dose for treatment of type 2 diabetes) .~Linagliptin: The subject will receive Linagliptin 5mg orally once daily for 12 weeks."
11223017|NCT02350478|BG001|Baseline|Placebo|"The subjects will receive placebo.~Placebo: The subject will receive placebo orally once daily for 12 weeks."
11223018|NCT02350478|BG002|Baseline|Total|Total of all reporting groups
11223019|NCT02350478|FG000|Participant Flow|Linagliptin|"The subjects will receive Linagliptin 5mg (licensed dose for treatment of type 2 diabetes) .~Linagliptin: The subject will receive Linagliptin 5mg orally once daily for 12 weeks."
11223020|NCT02350478|FG001|Participant Flow|Placebo|"The subjects will receive placebo.~Placebo: The subject will receive placebo orally once daily for 12 weeks."
11223021|NCT02350478|OG000|Outcome|Linagliptin|"The subjects will receive Linagliptin 5mg (licensed dose for treatment of type 2 diabetes) .~Linagliptin: The subject will receive Linagliptin 5mg orally once daily for 12 weeks."
11223022|NCT02350478|OG001|Outcome|Placebo|"The subjects will receive placebo.~Placebo: The subject will receive placebo orally once daily for 12 weeks."
11223023|NCT02350478|EG000|Reported Event|Linagliptin|"The subjects will receive Linagliptin 5mg (licensed dose for treatment of type 2 diabetes) .~Linagliptin: The subject will receive Linagliptin 5mg orally once daily for 12 weeks."
11223024|NCT02350478|EG001|Reported Event|Placebo|"The subjects will receive placebo.~Placebo: The subject will receive placebo orally once daily for 12 weeks."
11223025|NCT02350569|BG000|Baseline|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
11223026|NCT02350569|FG000|Participant Flow|LDV/SOF|"LDV/SOF for 1 Day: 3 participants were called for transplant, received one dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg), but had their liver transplant cancelled. All 3 participants were rescreened and 2 were subsequently re-enrolled, transplanted, and continued into the Main Study.~Main Study (LDV/SOF 4 Weeks): One dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 hepatitis C virus (HCV) infection.~Retreatment (LDV/SOF 12 Weeks): Participants who completed treatment in the Main Study and experienced virologic failure had the option to be retreated with LDV/SOF for 12 weeks."
11223027|NCT02350569|OG000|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
11223028|NCT02350569|EG000|Reported Event|LDV/SOF for 1 Day|Adverse events reported in this group include participants who received LDV/SOF on Day -1, but did not receive a liver transplant. All 3 participants were rescreened, but only 2 were re-enrolled, transplanted, and received LDV/SOF for 4 weeks.
11223029|NCT02350569|EG001|Reported Event|Main Study (LDV/SOF 4 Weeks)|Adverse events reported in this group include participants with chronic genotype 1 HCV infection who received one dose of LDV/SOF (90/400 mg) prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant.
11223030|NCT02350569|EG002|Reported Event|Retreatment (LDV/SOF 12 Weeks)|Adverse events reported in this group include 1 participant who completed treatment and experienced virologic failure in the Main Study and was retreated with an additional 12 weeks of LDV/SOF.
11223031|NCT02350647|BG000|Baseline|HEALICOIL Regenesorb|"Suture anchor for rotator cuff repair~Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors"
11223032|NCT02350647|BG001|Baseline|Twinfix Ultra HA|"Suture anchor for rotator cuff repair~Suture anchor Twinfix Ultra HA"
11223033|NCT02350647|BG002|Baseline|Total|Total of all reporting groups
11223034|NCT02350647|FG000|Participant Flow|HEALICOIL Regenesorb|"Suture anchor for rotator cuff repair~Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors"
11223035|NCT02350647|FG001|Participant Flow|Twinfix Ultra HA|"Suture anchor for rotator cuff repair~Suture anchor Twinfix Ultra HA"
11223036|NCT02350647|OG000|Outcome|HEALICOIL Regenesorb|"Suture anchor for rotator cuff repair~Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors"
11223037|NCT02350647|OG001|Outcome|Twinfix Ultra HA|"Suture anchor for rotator cuff repair~Suture anchor Twinfix Ultra HA"
11223038|NCT02350647|EG000|Reported Event|HEALICOIL Regenesorb|"Suture anchor for rotator cuff repair~Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors"
11223039|NCT02350647|EG001|Reported Event|Twinfix Ultra HA|"Suture anchor for rotator cuff repair~Suture anchor Twinfix Ultra HA"
11223040|NCT02350660|BG000|Baseline|Cow's Milk for Alpha-gal Allergics|"daily consumption of cow's milk~cow's milk: daily consumption of cow's milk"
11223041|NCT02350660|BG001|Baseline|Peanut Powder|"peanut oral immunotherapy~peanut powder: peanut oral immunotherapy"
11223042|NCT02350660|BG002|Baseline|Total|Total of all reporting groups
11223043|NCT02350660|FG000|Participant Flow|Cow's Milk for Alpha-gal Allergics|"daily consumption of cow's milk~cow's milk: daily consumption of cow's milk"
11223044|NCT02350660|FG001|Participant Flow|Peanut Powder|"peanut oral immunotherapy~peanut powder: peanut oral immunotherapy"
11223045|NCT02350660|OG000|Outcome|Cow's Milk for Alpha-gal Allergics|"daily consumption of cow's milk~cow's milk: daily consumption of cow's milk"
10845509|NCT00267189|OG001|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
11223046|NCT02350660|OG001|Outcome|Peanut Powder|"peanut oral immunotherapy~peanut powder: peanut oral immunotherapy"
11223047|NCT02350660|EG000|Reported Event|Cow's Milk for Alpha-gal Allergics|"daily consumption of cow's milk~cow's milk: daily consumption of cow's milk"
11223048|NCT02350660|EG001|Reported Event|Peanut Powder|"peanut oral immunotherapy~peanut powder: peanut oral immunotherapy"
10845510|NCT00267189|EG000|Reported Event|Group 1 (Everolimus)|Reduced calcineurin inhibitor dose + everolimus (1.5 mg twice daily) ± steroids
10845511|NCT00267189|EG001|Reported Event|Group 2 (Control)|Standard calcineurin inhibitor dose ± mycophenolate acid/azathioprine ± steroids
10845512|NCT00267202|BG000|Baseline|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
10845513|NCT00267202|BG001|Baseline|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
10845514|NCT00267202|BG002|Baseline|Total|Total of all reporting groups
10845515|NCT00267202|FG000|Participant Flow|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
10845516|NCT00267202|FG001|Participant Flow|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
10845517|NCT00267202|OG000|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
10845518|NCT00267202|OG001|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
10845519|NCT00267202|OG002|Outcome|All Patients|
10845520|NCT00267202|EG000|Reported Event|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
10845521|NCT00267202|EG001|Reported Event|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
10845522|NCT00267293|BG000|Baseline|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
10845523|NCT00267293|BG001|Baseline|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
10845524|NCT00267293|BG002|Baseline|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
10845525|NCT00267293|BG003|Baseline|Total|Total of all reporting groups
10845526|NCT00267293|FG000|Participant Flow|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
10845527|NCT00267293|FG001|Participant Flow|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
10845528|NCT00267293|FG002|Participant Flow|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
10845529|NCT00267293|OG000|Outcome|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
10855707|NCT00330759|BG000|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
10855708|NCT00330759|BG001|Baseline|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
10855709|NCT00330759|BG002|Baseline|Total|Total of all reporting groups
10855710|NCT00330759|FG000|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
10855711|NCT00330759|FG001|Participant Flow|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
10855712|NCT00330759|OG000|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
10855713|NCT00330759|OG001|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
10855714|NCT00330759|EG000|Reported Event|Zoledronic Acid 4 mg Q4W|
10855715|NCT00330759|EG001|Reported Event|Denosumab 120 mg Q4W|
10855716|NCT00330863|BG000|Baseline|Injectable|"Participants assigned to receive long-acting injectable risperidone~Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks."
10855717|NCT00330863|BG001|Baseline|Oral|"Participants assigned to receive oral atypical antipsychotic medication~Risperidone: Target dose is 4 mg/day.~Olanzapine: Target dose is 15 mg/day.~Quetiapine: Target dose is 600 mg/day.~Ziprasidone: Target dose is 120 mg/day.~Aripiprazole: Target dose is 20 mg/day.~Paliperidone: Target dose is 6 mg/day."
10855718|NCT00330863|BG002|Baseline|Total|Total of all reporting groups
10855719|NCT00330863|FG000|Participant Flow|Injectable|"Participants assigned to receive long-acting injectable risperidone~Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks."
10855720|NCT00330863|FG001|Participant Flow|Oral|"Participants assigned to receive oral atypical antipsychotic medication~Risperidone: Target dose is 4 mg/day.~Olanzapine: Target dose is 15 mg/day.~Quetiapine: Target dose is 600 mg/day.~Ziprasidone: Target dose is 120 mg/day.~Aripiprazole: Target dose is 20 mg/day.~Paliperidone: Target dose is 6 mg/day."
10855721|NCT00330863|OG000|Outcome|Injectable|"Participants assigned to receive long-acting injectable risperidone~Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks."
10855722|NCT00330863|OG001|Outcome|Oral|"Participants assigned to receive oral atypical antipsychotic medication~Risperidone: Target dose is 4 mg/day.~Olanzapine: Target dose is 15 mg/day.~Quetiapine: Target dose is 600 mg/day.~Ziprasidone: Target dose is 120 mg/day.~Aripiprazole: Target dose is 20 mg/day.~Paliperidone: Target dose is 6 mg/day."
10855723|NCT00330863|EG000|Reported Event|Injectable|"Participants assigned to receive long-acting injectable risperidone~Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks."
10855724|NCT00330863|EG001|Reported Event|Oral|"Participants assigned to receive oral atypical antipsychotic medication~Risperidone: Target dose is 4 mg/day.~Olanzapine: Target dose is 15 mg/day.~Quetiapine: Target dose is 600 mg/day.~Ziprasidone: Target dose is 120 mg/day.~Aripiprazole: Target dose is 20 mg/day.~Paliperidone: Target dose is 6 mg/day."
10855725|NCT00330876|BG000|Baseline|Safety Population|Subjects who received at least one dose of Pitavastatin 2 or 4 mg once daily
10855726|NCT00330876|FG000|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
10855727|NCT00330876|FG001|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10855728|NCT00330876|OG000|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
10855729|NCT00330876|OG001|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10855730|NCT00330876|EG000|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
10855731|NCT00330876|EG001|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
10855732|NCT00330915|BG000|Baseline|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
10855733|NCT00330915|FG000|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
10855734|NCT00330915|OG000|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
10855735|NCT00330915|EG000|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
10855736|NCT00330928|BG000|Baseline|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
10855737|NCT00330928|FG000|Participant Flow|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
10855738|NCT00330928|OG000|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
10855739|NCT00330928|EG000|Reported Event|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
10855740|NCT00330967|BG000|Baseline|Group 1|"Systemic Intralipid infusion subjects~20% Intralipid: lipid infusion"
10855741|NCT00330967|BG001|Baseline|Group 2|"Femoral Intralipid infusion subjects~20% Intralipid: lipid infusion"
10855742|NCT00330967|BG002|Baseline|Total|Total of all reporting groups
10855743|NCT00330967|FG000|Participant Flow|Group 1|"Systemic Intralipid infusion subjects~20% Intralipid: lipid infusion"
10855744|NCT00330967|FG001|Participant Flow|Group 2|"Femoral arterial Intralipid infusion subjects~20% Intralipid: lipid infusion"
10855745|NCT00330967|OG000|Outcome|Group 2|"Femoral Intralipid infusion subjects~20% Intralipid: lipid infusion"
10855746|NCT00330967|OG000|Outcome|Group 2|Femoral Intralipid infusion group
10855747|NCT00330967|EG000|Reported Event|Group 1|"Systemic Intralipid infusion group~20% Intralipid: lipid infusion"
10855748|NCT00330967|EG001|Reported Event|Group 2|"Femoral Intralipid infusion group~20% Intralipid: lipid infusion"
10855749|NCT00331006|BG000|Baseline|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
10855750|NCT00331006|FG000|Participant Flow|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
10855751|NCT00331006|OG000|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
10855752|NCT00331006|EG000|Reported Event|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
10855753|NCT00331136|BG000|Baseline|Group A (Tablets)|Pyronaridine artesunate 6:2 mg/kg
10855754|NCT00331136|BG001|Baseline|Group B (Tablets)|Pyronaridine artesunate 9:3 mg/kg
10855755|NCT00331136|BG002|Baseline|Group C (Tablets)|Pyronaridine artesunate 12:4 mg/kg
10855756|NCT00331136|BG003|Baseline|Group D (Granules)|Pyronaridine artesunate 9:3 mg/kg
10855757|NCT00331136|BG004|Baseline|Total|Total of all reporting groups
10855758|NCT00331136|FG000|Participant Flow|Group A (Tablets)|Pyronaridine artesunate 6:2 mg/kg. Number of PA tablets (48 mg + 16 mg) administered based on posology. 3-day course of once-daily dosing.
10855759|NCT00331136|FG001|Participant Flow|Group B (Tablets)|Pyronaridine artesunate 9:3 mg/kg. Number of PA tablets (72 mg + 24 mg) administered based on posology. 3-day course of once-daily dosing.
10855760|NCT00331136|FG002|Participant Flow|Group C (Tablets)|Pyronaridine artesunate 12:4 mg/kg. Number of PA tablets (96 mg + 32 mg) administered based on posology. 3-day course of once-daily dosing.
10855761|NCT00331136|FG003|Participant Flow|Group D (Granules)|Pyronaridine artesunate 9:3 mg/kg. Number of PA sachets containing granules (60 mg + 20 mg) administered based on posology. Sachet is administered as a suspension with water. 3-day course of once-daily dosing.
10855762|NCT00331136|OG000|Outcome|Group A (Tablets)|Pyronaridine artesunate 6:2 mg/kg
10855763|NCT00331136|OG001|Outcome|Group B (Tablets)|Pyronaridine artesunate 9:3 mg/kg
10855764|NCT00331136|OG002|Outcome|Group C (Tablets)|Pyronaridine artesunate 12:4 mg/kg
10855765|NCT00331136|OG003|Outcome|Group D (Granules)|Pyronaridine artesunate 9:3 mg/kg
10855766|NCT00331136|EG000|Reported Event|Group A (Tablets)|Pyronaridine artesunate 6:2 mg/kg
10855767|NCT00331136|EG001|Reported Event|Group B (Tablets)|Pyronaridine artesunate 9:3 mg/kg
10855768|NCT00331136|EG002|Reported Event|Group C (Tablets)|Pyronaridine artesunate 12:4 mg/kg
10855769|NCT00331136|EG003|Reported Event|Group D (Granules)|Pyronaridine artesunate 9:3 mg/kg
10855770|NCT00331162|BG000|Baseline|Alemtuzumab|Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
10855771|NCT00331162|BG001|Baseline|Anti-Thymocyte Globulin|"Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr < 3-4 mg/dL.~Give first dose over 6 hours, subsequent doses over 4 hours.~Premedication to be given with the first 3 doses:~Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.~Hold infusion if temperature > 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours"
10855772|NCT00331162|BG002|Baseline|Total|Total of all reporting groups
10855773|NCT00331162|FG000|Participant Flow|Alemtuzumab|Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
10855774|NCT00331162|FG001|Participant Flow|Anti-Thymocyte Globulin|"Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr < 3-4 mg/dL.~Give first dose over 6 hours, subsequent doses over 4 hours.~Premedication to be given with the first 3 doses:~Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.~Hold infusion if temperature > 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours"
10855775|NCT00331162|OG000|Outcome|Alemtuzumab|Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
10855776|NCT00331162|OG001|Outcome|Anti-Thymocyte Globulin|"Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr < 3-4 mg/dL.~Give first dose over 6 hours, subsequent doses over 4 hours.~Premedication to be given with the first 3 doses:~Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.~Hold infusion if temperature > 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours"
10855777|NCT00331162|EG000|Reported Event|Alemtuzumab|Alemtuzumab: 30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
10855778|NCT00331162|EG001|Reported Event|Anti-Thymocyte Globulin|"Anti-Thymocyte Globulin: 1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr < 3-4 mg/dL.~Give first dose over 6 hours, subsequent doses over 4 hours.~Premedication to be given with the first 3 doses:~Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.~Hold infusion if temperature > 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours"
10855779|NCT00331344|BG000|Baseline|Treatment (Combination Chemotherapy)|"Patients receive mitoxantrone hydrochloride IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855780|NCT00331344|FG000|Participant Flow|Phase I Group I|"Patients receive mitoxantrone hydrochloride 8mg/m2 IV over 30 minutes and ixabepilone 20mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
11223049|NCT02350816|BG000|Baseline|Group 1|Participants continued HGT-1410 treatment from HGT-SAN-093 (NCT02350816) study at a dose of 45 milligrams (mg) administered intrathecally (IT) via IT drug delivery device (IDDD) every 2 weeks (Q2W) started at Week 50, with a cumulative treatment period of up to 42 months (168 weeks).
11223050|NCT02350816|BG001|Baseline|Group 2|Participants continued HGT-1410 treatment from HGT-SAN-093 (NCT02350816) study at a dose of 45 mg administered intrathecally IDDD every 4 weeks (Q4W) started at Week 52, with a cumulative treatment period of up to 42 months (168 weeks).
10976845|NCT00942357|BG001|Baseline|Arm II (Paclitaxel and Carboplatin)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10845530|NCT00267293|OG001|Outcome|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
10976846|NCT00942357|BG002|Baseline|Total|Total of all reporting groups
10855781|NCT00331344|FG001|Participant Flow|Phase I Group II|"Patients receive mitoxantrone hydrochloride 8mg/m2 IV over 30 minutes and ixabepilone 25mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855782|NCT00331344|FG002|Participant Flow|Phase I Group III|"Patients receive mitoxantrone hydrochloride 10mg/m2 IV over 30 minutes and ixabepilone 25mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855783|NCT00331344|FG003|Participant Flow|Phase I Group IV|"Patients receive mitoxantrone hydrochloride 10mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855784|NCT00331344|FG004|Participant Flow|Phase I Group V|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855785|NCT00331344|FG005|Participant Flow|Phase I Group VI|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855786|NCT00331344|FG006|Participant Flow|Phase I Group Va|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
10855787|NCT00331344|FG007|Participant Flow|Phase I Group VIa|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
10855788|NCT00331344|FG008|Participant Flow|Phase II|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
10845531|NCT00267293|OG002|Outcome|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
10845532|NCT00267293|EG000|Reported Event|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
10845533|NCT00267293|EG001|Reported Event|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
10845534|NCT00267293|EG002|Reported Event|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
10845535|NCT00267488|BG000|Baseline|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
10845536|NCT00267488|FG000|Participant Flow|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
10845537|NCT00267488|OG000|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
10845538|NCT00267488|EG000|Reported Event|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
10855789|NCT00331344|OG000|Outcome|Treatment (Combination Chemotherapy)|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
10855790|NCT00331344|OG000|Outcome|Phase I Treatment (Groups I-VIa)|"Patients receive mitoxantrone hydrochloride 8-12mg/m2 IV over 30 minutes and ixabepilone 20-35mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Patients in groups Va and VIa also received pegfilgrastim 6mg SC on day 2. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
10855791|NCT00331344|OG000|Outcome|Phase I Group I|"Patients receive mitoxantrone hydrochloride 8 mg/m2 IV over 30 minutes and ixabepilone 20mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855792|NCT00331344|OG001|Outcome|Phase Group II|"Patients receive mitoxantrone hydrochloride 8 mg/m2 IV over 30 minutes and ixabepilone 25mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855793|NCT00331344|OG002|Outcome|Phase I Group III|"Patients receive mitoxantrone hydrochloride 10 mg/m2 IV over 30 minutes and ixabepilone 25 mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855794|NCT00331344|OG003|Outcome|Phase I Group IV|"Patients receive mitoxantrone hydrochloride 10 mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855795|NCT00331344|OG004|Outcome|Phase I Group V|"Patients receive mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855796|NCT00331344|OG005|Outcome|Phase I Group VI|"Patients receive mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
10855797|NCT00331344|OG006|Outcome|Phase I Group Va|"Patients receive mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
10855798|NCT00331344|OG007|Outcome|Phase I Group VIa|"Patients receive mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
10855799|NCT00331344|EG000|Reported Event|Phase I and Phase II (Cumulative)|"Patients in the Phase I period receive mitoxantrone hydrochloride 8-12mg/m2 IV over 30 minutes and ixabepilone 20-35mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Patients in groups Va and VIa also received pegfilgrastim 6mg SC on day 2. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~Patients in Phase II receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~Adverse Events below are reported cumulatively for the entire study.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
10855800|NCT00331409|BG000|Baseline|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
10855801|NCT00331409|FG000|Participant Flow|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
10855802|NCT00331409|OG000|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
10855803|NCT00331409|EG000|Reported Event|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
10855804|NCT00331422|BG000|Baseline|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
10855805|NCT00331422|FG000|Participant Flow|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
11223051|NCT02350816|BG002|Baseline|Group 3A|Participants in Group 3A were not treated in HGT-SAN-093 (NCT02350816) study. Participants received HGT-1410 treatment at a dose of 45mg administered intrathecally IDDD Q2W started at Week 0 of the current extension study (SHP610-201=2014-003960-20), with a cumulative treatment period of up to 30 months (120 weeks).
10855806|NCT00331422|OG000|Outcome|Evaluable Patients (Received 4 Cycles of Therapy and Surgery)|Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
10855807|NCT00331422|OG000|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
10855808|NCT00331422|EG000|Reported Event|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
10855809|NCT00331552|BG000|Baseline|Phase I: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855810|NCT00331552|BG001|Baseline|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855811|NCT00331552|BG002|Baseline|Total|Total of all reporting groups
11007029|NCT01089127|BG000|Baseline|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11223052|NCT02350816|BG003|Baseline|Group 3B|Participants in Group 3B were not treated in HGT-SAN-093 (NCT02350816) study. Participants received HGT-1410 treatment at a dose of 45mg administered intrathecally via IDDD Q4W started at Week 0 of the current extension study (SHP610-201=2014-003960-20), with a cumulative treatment period of up to 30 months (120 weeks).
11223053|NCT02350816|BG004|Baseline|Total|Total of all reporting groups
10845539|NCT00267631|BG000|Baseline|At Risk Body Weight|Children with BMI greater adn equal to 85%
10976847|NCT00942357|FG000|Participant Flow|Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)|"Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Cisplatin: Given IV~Internal Radiation Therapy: Undergo brachytherapy~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy"
10976848|NCT00942357|FG001|Participant Flow|Arm II (Paclitaxel and Carboplatin)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10976849|NCT00942357|OG000|Outcome|Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)|"Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Cisplatin: Given IV~Internal Radiation Therapy: Undergo brachytherapy~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy"
10845540|NCT00267631|BG001|Baseline|Normal Body Weight|Children with a BMI of 25 to 75%
10845541|NCT00267631|BG002|Baseline|Total|Total of all reporting groups
10845542|NCT00267631|FG000|Participant Flow|At Risk Body Weight|Children with BMI greater and equal to 85%
10845543|NCT00267631|FG001|Participant Flow|NOrmal Body Weight|Children with BMI of 25-75%
10845544|NCT00267631|OG000|Outcome|At Risk Body Weight|Children with BMI greater and equal to 85%
10845545|NCT00267631|OG001|Outcome|Normal Body Weight|Children with BMI of 25-75%
10845546|NCT00267631|EG000|Reported Event|At Risk Body Weight|Children with a BMI greater and equal to 85%
10845547|NCT00267631|EG001|Reported Event|Normal Body Weight|Children with a BMI of 25 to 75%
10845548|NCT00267644|BG000|Baseline|Cases|
10845549|NCT00267644|BG001|Baseline|Controls|
10845550|NCT00267644|BG002|Baseline|Total|Total of all reporting groups
10845551|NCT00267644|FG000|Participant Flow|Cases|Dehydrated Pediatric Patients
10845552|NCT00267644|FG001|Participant Flow|Controls|Hydrated Pediatric Patients
10845553|NCT00267644|OG000|Outcome|Cases|Pediatric Patients who were dehydrated
10845554|NCT00267644|OG001|Outcome|Controls|Pediatric Patients that were hydrated
10845555|NCT00267644|OG000|Outcome|Cases|Dehydrated Pediatric Patients
10845556|NCT00267644|OG001|Outcome|Controls|Hydrated Pediatric Patients
10845557|NCT00267644|EG000|Reported Event|Cases|
10845558|NCT00267644|EG001|Reported Event|Controls|
10845559|NCT00267670|BG000|Baseline|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
10845560|NCT00267670|BG001|Baseline|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
10845561|NCT00267670|BG002|Baseline|Total|Total of all reporting groups
10845562|NCT00267670|FG000|Participant Flow|Pentoxifylline|This group was given pentoxifylline 400mg thrice daily (tid) for 1 year
10845563|NCT00267670|FG001|Participant Flow|Placebo|This group was given a capsule identical to pentoxifylline that contained sucrose.
10845564|NCT00267670|OG000|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
10845565|NCT00267670|OG001|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
10845566|NCT00267670|OG001|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
10845567|NCT00267670|EG000|Reported Event|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
10845568|NCT00267670|EG001|Reported Event|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
10845569|NCT00267696|BG000|Baseline|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administred on day 1 and day 15 of a 28 day cycle~Carboplatin"
10845570|NCT00267696|FG000|Participant Flow|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
10845571|NCT00267696|OG000|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
10845572|NCT00267696|EG000|Reported Event|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
10845573|NCT00267748|BG000|Baseline|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
10976850|NCT00942357|OG001|Outcome|Arm II (Paclitaxel and Carboplatin)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11223054|NCT02350816|FG000|Participant Flow|Group 1|Participants continued HGT-1410 treatment from HGT-SAN-093 (NCT02350816) study at a dose of 45 milligrams (mg) administered intrathecally (IT) via IT drug delivery device (IDDD) every 2 weeks (Q2W) started at Week 50, with a cumulative treatment period of up to 42 months (168 weeks).
10845574|NCT00267748|BG001|Baseline|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
10845575|NCT00267748|BG002|Baseline|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
10855812|NCT00331552|FG000|Participant Flow|Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855813|NCT00331552|FG001|Participant Flow|Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855814|NCT00331552|OG000|Outcome|Phase I: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855815|NCT00331552|OG000|Outcome|Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855816|NCT00331552|OG000|Outcome|Doxil 30 mg/m^2|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855817|NCT00331552|OG001|Outcome|Doxil 35 mg/m^2|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855818|NCT00331552|OG000|Outcome|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855819|NCT00331552|OG000|Outcome|Heavily Pre-treated|1 or more regimens for advanced disease
10855820|NCT00331552|OG001|Outcome|Less Heavily Pre-treated|no regimens for advanced disease
11223055|NCT02350816|FG001|Participant Flow|Group 2|Participants continued HGT-1410 treatment from HGT-SAN-093 (NCT02350816) study at a dose of 45 mg administered intrathecally IDDD every 4 weeks (Q4W) started at Week 52, with a cumulative treatment period of up to 42 months (168 weeks).
10855821|NCT00331552|EG000|Reported Event|Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855822|NCT00331552|EG001|Reported Event|Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
10855823|NCT00331630|BG000|Baseline|Treatment With Lapatinib and Abraxane|"30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
10855824|NCT00331630|FG000|Participant Flow|Treatment Arm|"30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
10878896|NCT00454649|FG007|Participant Flow|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
11223056|NCT02350816|FG002|Participant Flow|Group 3A|Participants in Group 3A were not treated in HGT-SAN-093 (NCT02350816) study. Participants received HGT-1410 treatment at a dose of 45mg administered intrathecally IDDD Q2W started at Week 0 of the current extension study (SHP610-201=2014-003960-20), with a cumulative treatment period of up to 30 months (120 weeks).
10845576|NCT00267748|BG003|Baseline|Total|Total of all reporting groups
11223057|NCT02350816|FG003|Participant Flow|Group 3B|Participants in Group 3B were not treated in HGT-SAN-093 (NCT02350816) study. Participants received HGT-1410 treatment at a dose of 45mg administered intrathecally via IDDD Q4W started at Week 0 of the current extension study (SHP610-201=2014-003960-20), with a cumulative treatment period of up to 30 months (120 weeks).
10855825|NCT00331630|OG000|Outcome|Treatment With Lapatinib and Abraxane|"30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
10855826|NCT00331630|EG000|Reported Event|Treatment With Lapatinib and Abraxane|"30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
10855827|NCT00331682|BG000|Baseline|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
10855828|NCT00331682|FG000|Participant Flow|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~alvocidib: Given IV~docetaxel: Given IV"
10855829|NCT00331682|OG000|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
10855830|NCT00331682|EG000|Reported Event|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
10855831|NCT00331760|BG000|Baseline|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
10855832|NCT00331760|BG001|Baseline|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
10855833|NCT00331760|BG002|Baseline|Total|Total of all reporting groups
10855834|NCT00331760|FG000|Participant Flow|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
10855835|NCT00331760|FG001|Participant Flow|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
10855836|NCT00331760|OG000|Outcome|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
10855837|NCT00331760|OG001|Outcome|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
10855838|NCT00331760|OG000|Outcome|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
10855839|NCT00331760|EG000|Reported Event|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
10855840|NCT00331760|EG001|Reported Event|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
10855841|NCT00331799|BG000|Baseline|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
10855842|NCT00331799|FG000|Participant Flow|Open Label Treatment With Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg / day .
10855843|NCT00331799|OG000|Outcome|Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
10855844|NCT00331799|EG000|Reported Event|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
10855845|NCT00331864|BG000|Baseline|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
10855846|NCT00331864|BG001|Baseline|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
10855847|NCT00331864|BG002|Baseline|Total|Total of all reporting groups
10855848|NCT00331864|FG000|Participant Flow|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
10855849|NCT00331864|FG001|Participant Flow|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
11223058|NCT02350816|OG000|Outcome|Group 1|Participants continued HGT-1410 treatment from HGT-SAN-093 (NCT02350816) study at a dose of 45 milligrams (mg) administered intrathecally (IT) via IT drug delivery device (IDDD) every 2 weeks (Q2W) started at Week 50, with a cumulative treatment period of up to 42 months (168 weeks).
10855850|NCT00331864|OG000|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
10855851|NCT00331864|OG001|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
10855852|NCT00331864|EG000|Reported Event|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
10855853|NCT00331864|EG001|Reported Event|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
10855854|NCT00332163|BG000|Baseline|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
10855855|NCT00332163|BG001|Baseline|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
10855856|NCT00332163|BG002|Baseline|Total|Total of all reporting groups
10855857|NCT00332163|FG000|Participant Flow|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
10855858|NCT00332163|FG001|Participant Flow|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
10855859|NCT00332163|OG000|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
10855860|NCT00332163|OG001|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
10855861|NCT00332163|EG000|Reported Event|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
10855862|NCT00332163|EG001|Reported Event|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
10855863|NCT00332189|BG000|Baseline|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
10855864|NCT00332189|FG000|Participant Flow|Total Patient Population|Phenoptin will be taken orally once daily as the number of tablets equivalent to that of the last prescribed dose of the previous study (PKU-004 NCT00225615 or PKU-006 NCT00272792). Subjects who participated in PKU-006 NCT00272792 will receive Phenoptin as the number of tablets equivalent to 20 mg/kg/day at enrollment. The Phenoptin dose may be adjusted up or down as needed at the discretion of the investigator in increments of approximately 5 mg/kg/day within a range of 5 mg/kg/day to 20 mg/kg/day to control blood Phe to levels consistent with local clinical site recommendations for blood Phe control.
10855865|NCT00332189|OG000|Outcome|Total Patient Population|The safety analysis population includes all subjects who received at least one dose of study drug during the study.
10855866|NCT00332189|OG000|Outcome|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
10855867|NCT00332189|EG000|Reported Event|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
10855868|NCT00332202|BG000|Baseline|Enzastaurin: Arm A - Experimental|Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1.
10855869|NCT00332202|BG001|Baseline|Placebo: Arm B - Control|Placebo administered PO QD after an initial loading dose of placebo on Day 1.
10855870|NCT00332202|BG002|Baseline|Total|Total of all reporting groups
10855871|NCT00332202|FG000|Participant Flow|Enzastaurin: Arm A - Experimental|Enzastaurin 500 milligram (mg) administered orally (PO) each day (QD) after an initial loading dose of 1125 mg on Day 1.
10855872|NCT00332202|FG001|Participant Flow|Placebo: Arm B - Control|Placebo administered PO QD after an initial loading dose of placebo on Day 1.
10855873|NCT00332202|OG000|Outcome|Enzastaurin: Arm A - Experimental|Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1.
10855874|NCT00332202|OG001|Outcome|Placebo: Arm B - Control|Placebo administered PO QD after an initial loading dose of placebo on Day 1.
10855875|NCT00332202|OG000|Outcome|Enzastaurin: Arm A - Experimental With Germinal-center B-cells|Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1.Participants from enzastaurin treatment group with diffuse large B-cell lymphoma expression profile similar to germinal-center B-cells.
10855876|NCT00332202|OG001|Outcome|Enzastaurin: Arm A - Experimental Non-germinal-center B-cells|Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Participants from the placebo treatment group with diffuse large B-cell lymphoma expression profile not similar to germinal-center B-cells
10855877|NCT00332202|OG002|Outcome|Placebo: Arm B - Control With Germinal-center B-cells|Placebo administered PO QD after an initial loading dose of placebo on Day 1.Participants from the placebo treatment group with diffuse large B-cell lymphoma expression profile not similar to germinal-center B-cells.
10855878|NCT00332202|OG003|Outcome|Placebo Arm B- Control With Non-germinal-center B-cells|Placebo administered PO QD after an initial loading dose of placebo on Day 1. Participants from the placebo treatment group with diffuse large B-cell lymphoma expression profile not similar to germinal-center B-cells.
10855879|NCT00332202|OG000|Outcome|Enzastaurin: Arm A With PKC-β2 Cytoplasm (High Expression)|Participants from enzastaurin treatment groups with PKC-β2 cytoplasmic protein expression.
10855880|NCT00332202|OG001|Outcome|Enzastaurin: Arm A With PKC-β2 Cytoplasm (Low Expression)|Participants from enzastaurin treatment groups with PKC-β2 cytoplasmic protein expression.
10855881|NCT00332202|OG002|Outcome|Placebo: Arm B With PKC-β2 Cytoplasm (High Expression)|Participants from placebo treatment group with PKC-β2 cytoplasmic protein expression.
10855882|NCT00332202|OG003|Outcome|Placebo: Arm B With PKC-β2 Cytoplasm (Low Expression)|Participants from placebo treatment group with PKC-β2 cytoplasmic protein expression.
10855883|NCT00332202|OG000|Outcome|Total Enzastaurin Population|All participants who received enzastaurin 500 mg PO QD after an initial loading dose of 1125 mg on Day 1.
10855884|NCT00332202|EG000|Reported Event|Enzastaurin: Arm A - Experimental|Administered orally as four 125-mg tablets daily (after an initial loading dose of three 125-mg tablets given three times on Day 1)
10855885|NCT00332202|EG001|Reported Event|Placebo: Arm B - Control|Administered orally as four tablets daily (after an initial loading dose of three tablets given three times on Day 1)
10855886|NCT00332241|BG000|Baseline|Placebo|oral placebo once daily (QD)
10855887|NCT00332241|BG001|Baseline|Aripiprazole|oral aripiprazole 2 to 15 mg QD
10855888|NCT00332241|BG002|Baseline|Total|Total of all reporting groups
10855889|NCT00332241|FG000|Participant Flow|Placebo|oral placebo once daily (QD)
10855890|NCT00332241|FG001|Participant Flow|Aripiprazole|oral aripiprazole 2 to 15 mg QD
10855891|NCT00332241|OG000|Outcome|Placebo|oral placebo once daily (QD)
10855892|NCT00332241|OG001|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
10855893|NCT00332241|EG000|Reported Event|Aripiprazole|
10855894|NCT00332241|EG001|Reported Event|Placebo|
10855895|NCT00332332|BG000|Baseline|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
10855896|NCT00332332|FG000|Participant Flow|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
10855897|NCT00332332|OG000|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
10855898|NCT00332332|EG000|Reported Event|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
10855899|NCT00332462|BG000|Baseline|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
10855900|NCT00332462|FG000|Participant Flow|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
10855901|NCT00332462|OG000|Outcome|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
10855902|NCT00332462|OG000|Outcome|3 Months After Transplantation|
10855903|NCT00332462|OG001|Outcome|6 Months After Transplantation|
10855904|NCT00332462|EG000|Reported Event|Cyclosporine (Sandimmun® i.v.)|Cyclosporine (Sandimmun®) intravenous (i.v) given 2 times daily as an infusion over a four hour period staring at a dose of 2 X 200 mg/day and continuing for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
10855905|NCT00332462|EG001|Reported Event|Cyclosporine (Sandimmun® Optoral)|Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
10855906|NCT00332488|BG000|Baseline|TI Inhalation Powder Alone|
10855907|NCT00332488|BG001|Baseline|Metformin & Secretagogues|
10855908|NCT00332488|BG002|Baseline|TI Inhalation Powder + Metformin|
10855909|NCT00332488|BG003|Baseline|Total|Total of all reporting groups
10855910|NCT00332488|FG000|Participant Flow|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder administered prior to each meal without any other anti-diabetic treatment; dose individualized for each subject
10855911|NCT00332488|FG001|Participant Flow|Metformin & Secretagogues|Metformin (>= 1,000 mg/day or maximum tolerate dose) & Secretagogue (Sulfonylurea or meglitinide at >= half maximum manufacturer recommended dose or maximum tolerated dose)
10855912|NCT00332488|FG002|Participant Flow|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder administered prior to each meal (dose individualized for each subject) & Metformin (>= 1,000 mg/day or maximum tolerate dose)
10855913|NCT00332488|OG000|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
10855914|NCT00332488|OG001|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
10855915|NCT00332488|OG000|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
10855916|NCT00332488|OG001|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
10855917|NCT00332488|OG002|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
10855918|NCT00332488|EG000|Reported Event|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
10855919|NCT00332488|EG001|Reported Event|Metformin & Secretagogues|Metformin & Secretagogues
10855920|NCT00332488|EG002|Reported Event|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
10855921|NCT00332579|BG000|Baseline|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
10855922|NCT00332579|BG001|Baseline|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
10855923|NCT00332579|BG002|Baseline|Total|Total of all reporting groups
10855924|NCT00332579|FG000|Participant Flow|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
10855925|NCT00332579|FG001|Participant Flow|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
10855926|NCT00332579|OG000|Outcome|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
10855927|NCT00332579|OG001|Outcome|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
10855928|NCT00332579|EG000|Reported Event|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
10855929|NCT00332579|EG001|Reported Event|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
10855930|NCT00332605|BG000|Baseline|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
10855931|NCT00332605|BG001|Baseline|N-Acetyl Cysteine|600mg tablets taken by mouth daily
10855932|NCT00332605|BG002|Baseline|Placebo|
10855933|NCT00332605|BG003|Baseline|Total|Total of all reporting groups
10855934|NCT00332605|FG000|Participant Flow|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
10855935|NCT00332605|FG001|Participant Flow|N-Acetyl Cysteine|600mg tablets taken by mouth daily
10855936|NCT00332605|FG002|Participant Flow|Placebo|
10855937|NCT00332605|OG000|Outcome|Naltrexone|Naltrexone tablets
10855938|NCT00332605|OG001|Outcome|N-Acetyl Cysteine|600mg tablets, daily
10855939|NCT00332605|OG002|Outcome|Placebo|Placebo capsules
10855940|NCT00332605|EG000|Reported Event|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
10855941|NCT00332605|EG001|Reported Event|N-Acetyl Cysteine|600mg tablets taken by mouth daily
10855942|NCT00332605|EG002|Reported Event|Placebo|
10855943|NCT00332644|BG000|Baseline|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
10855944|NCT00332644|BG001|Baseline|Nicotine Lozenge|nicotine lozenge alone treatment
10855945|NCT00332644|BG002|Baseline|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
10855946|NCT00332644|BG003|Baseline|Bupropion|bupropion alone treatment
10855947|NCT00332644|BG004|Baseline|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
10855948|NCT00332644|BG005|Baseline|Placebo Control|placebo control (no active medication) treatment
10855949|NCT00332644|BG006|Baseline|Total|Total of all reporting groups
10855950|NCT00332644|FG000|Participant Flow|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
10855951|NCT00332644|FG001|Participant Flow|Nicotine Lozenge|nicotine lozenge alone treatment
10855952|NCT00332644|FG002|Participant Flow|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
10855953|NCT00332644|FG003|Participant Flow|Bupropion|bupropion alone treatment
10855954|NCT00332644|FG004|Participant Flow|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
10855955|NCT00332644|FG005|Participant Flow|Placebo Control|placebo control (no active medication) treatment
10855956|NCT00332644|OG000|Outcome|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
10855957|NCT00332644|OG001|Outcome|Nicotine Lozenge|nicotine lozenge alone treatment
10855958|NCT00332644|OG002|Outcome|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
10855959|NCT00332644|OG003|Outcome|Bupropion|bupropion alone treatment
10855960|NCT00332644|OG004|Outcome|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
10855961|NCT00332644|OG005|Outcome|Placebo Control|placebo control (no active medication) treatment
10855962|NCT00332644|EG000|Reported Event|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
10855963|NCT00332644|EG001|Reported Event|Nicotine Lozenge|nicotine lozenge alone treatment
10855964|NCT00332644|EG002|Reported Event|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
10855965|NCT00332644|EG003|Reported Event|Bupropion|bupropion alone treatment
10855966|NCT00332644|EG004|Reported Event|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
10855967|NCT00332644|EG005|Reported Event|Placebo Control|placebo control (no active medication) treatment
10855968|NCT00332696|BG000|Baseline|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
10855969|NCT00332696|BG001|Baseline|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
10855970|NCT00332696|BG002|Baseline|Total|Total of all reporting groups
10855971|NCT00332696|FG000|Participant Flow|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
10855972|NCT00332696|FG001|Participant Flow|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
10855973|NCT00332696|OG000|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
10855974|NCT00332696|OG001|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
10855975|NCT00332696|EG000|Reported Event|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
10855976|NCT00332696|EG001|Reported Event|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
10855977|NCT00332709|BG000|Baseline|Letrozole|Letrozole 2.5 mg/day for 3 years
10855978|NCT00332709|BG001|Baseline|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
10855979|NCT00332709|BG002|Baseline|Total|Total of all reporting groups
10855980|NCT00332709|FG000|Participant Flow|Letrozole|Letrozole 2.5 mg/day for 3 years
10855981|NCT00332709|FG001|Participant Flow|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
10855982|NCT00332709|OG000|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
10855983|NCT00332709|OG001|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
10855984|NCT00332709|EG000|Reported Event|Letrozole|Letrozole orally 2.5 mg/day for 3 years
10855985|NCT00332709|EG001|Reported Event|Letrozole + Zolendronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
10855986|NCT00332722|BG000|Baseline|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
10855987|NCT00332722|BG001|Baseline|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
10855988|NCT00332722|BG002|Baseline|Total|Total of all reporting groups
10855989|NCT00332722|FG000|Participant Flow|Group 1 Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
10855990|NCT00332722|FG001|Participant Flow|Group 2 With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
10855991|NCT00332722|OG000|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
10855992|NCT00332722|OG001|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
10855993|NCT00332722|EG000|Reported Event|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
10855994|NCT00332722|EG001|Reported Event|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
10855995|NCT00332839|BG000|Baseline|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
10855996|NCT00332839|BG001|Baseline|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
10855997|NCT00332839|BG002|Baseline|Total|Total of all reporting groups
10855998|NCT00332839|FG000|Participant Flow|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
10855999|NCT00332839|FG001|Participant Flow|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
10856000|NCT00332839|OG000|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
10856001|NCT00332839|OG001|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
10856002|NCT00332839|EG000|Reported Event|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
10856003|NCT00332839|EG001|Reported Event|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
10856004|NCT00333138|BG000|Baseline|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856005|NCT00333138|BG001|Baseline|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856006|NCT00333138|BG002|Baseline|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856007|NCT00333138|BG003|Baseline|Total|Total of all reporting groups
10856008|NCT00333138|FG000|Participant Flow|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856009|NCT00333138|FG001|Participant Flow|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856010|NCT00333138|FG002|Participant Flow|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856011|NCT00333138|OG000|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856012|NCT00333138|OG001|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856013|NCT00333138|OG002|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856014|NCT00333138|OG000|Outcome|FTY720 1.25 mg/Day|Patients randomized to fingolimod 1.25 mg/d in the core study who received fingolimod 1.25 mg/d in the dose-blind period of the extension study and initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
10856015|NCT00333138|OG001|Outcome|FTY720 5.0 mg/Day|Patients randomized to fingolimod 5.0 mg/d in the core study who received fingolimod 5.0 mg/d in the dose-blind period of the extension study. All patients received fingolimod 1.25 mg/d initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
10856016|NCT00333138|EG000|Reported Event|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856017|NCT00333138|EG001|Reported Event|Fingolimod (FTY720) 1.25 mg|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856018|NCT00333138|EG002|Reported Event|Fingolimod (FTY720) 5.0 mg|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
10856019|NCT00333177|BG000|Baseline|CT - RLAI|"Participants will receive cognitive remediation training plus injectable, long-acting risperidone.~Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.~Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~Individual Placement and Support: Supported education/employment"
10856020|NCT00333177|BG001|Baseline|HBT - RLAI|"Participants will receive health behavior training plus injectable, long-acting risperidone.~Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation.~Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~Individual Placement and Support: Supported education/employment"
10856021|NCT00333177|BG002|Baseline|CT - Oral Ris|"Participants will receive cognitive remediation training plus risperidone administered orally.~Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.~Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist~Individual Placement and Support: Supported education/employment"
10856022|NCT00333177|BG003|Baseline|HBT - Oral Ris|"Participants will receive health behavior training plus risperidone administered orally.~Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation.~Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist~Individual Placement and Support: Supported education/employment"
10856023|NCT00333177|BG004|Baseline|Total|Total of all reporting groups
10856024|NCT00333177|FG000|Participant Flow|CT - RLAI|"Participants will receive cognitive remediation training (CT) plus injectable, long-acting risperidone (RLAI).~Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.~Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~Individual Placement and Support: Supported education/employment"
10856025|NCT00333177|FG001|Participant Flow|HBT - RLAI|"Participants will receive health behavior training (HBT) plus injectable, long-acting risperidone (RLAI).~Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation.~Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~Individual Placement and Support: Supported education/employment"
10856026|NCT00333177|FG002|Participant Flow|CT - Oral Ris|"Participants will receive cognitive remediation training (CT) plus risperidone administered orally (Oral Ris).~Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.~Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist~Individual Placement and Support: Supported education/employment"
10856027|NCT00333177|FG003|Participant Flow|HBT - Oral Ris|"Participants will receive health behavior training (HBT) plus risperidone administered orally (Oral Ris).~Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation.~Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist~Individual Placement and Support: Supported education/employment"
10856028|NCT00333177|OG000|Outcome|CT - RLAI|"Participants will receive cognitive remediation training plus injectable, long-acting risperidone.~Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.~Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~Individual Placement and Support: Supported education/employment"
10856029|NCT00333177|OG001|Outcome|HBT - RLAI|"Participants will receive health behavior training plus injectable, long-acting risperidone.~Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation.~Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~Individual Placement and Support: Supported education/employment"
10856030|NCT00333177|OG002|Outcome|CT - Oral Ris|"Participants will receive cognitive remediation training plus risperidone administered orally.~Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.~Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist~Individual Placement and Support: Supported education/employment"
11223059|NCT02350816|OG001|Outcome|Group 2|Participants continued HGT-1410 treatment from HGT-SAN-093 (NCT02350816) study at a dose of 45 mg administered intrathecally IDDD every 4 weeks (Q4W) started at Week 52, with a cumulative treatment period of up to 42 months (168 weeks).
10856031|NCT00333177|OG003|Outcome|HBT - Oral Ris|"Participants will receive health behavior training plus risperidone administered orally.~Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation.~Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist~Individual Placement and Support: Supported education/employment"
10856032|NCT00333177|OG000|Outcome|RLAI|"Participants will receive risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~For this study aim, only the medication comparison is involved, so the cognitive training and Health Behaviors Training groups are combined within this medication condition. Participants will receive either cognitive remediation or healthy behaviors training plus risperidone administered by injection. All participants received individual Placement and Support: Supported education/employment"
10856033|NCT00333177|OG001|Outcome|Oral Ris|"Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist.~For this study aim, only the medication comparison is involved, so the cognitive training and Health Behaviors Training groups are combined within this medication condition. Participants will receive either cognitive remediation or healthy behaviors training plus risperidone administered orally.All participants received individual Placement and Support: Supported education/employment"
10856034|NCT00333177|EG000|Reported Event|CT - RLAI|"Participants will receive cognitive remediation training plus injectable, long-acting risperidone.~Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.~Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~Individual Placement and Support: Supported education/employment"
10856035|NCT00333177|EG001|Reported Event|HBT - RLAI|"Participants will receive health behavior training plus injectable, long-acting risperidone.~Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation.~Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed~Individual Placement and Support: Supported education/employment"
11007030|NCT01089127|BG001|Baseline|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11223060|NCT02350816|OG002|Outcome|Group 3A|Participants in Group 3A were not treated in HGT-SAN-093 (NCT02350816) study. Participants received HGT-1410 treatment at a dose of 45mg administered intrathecally IDDD Q2W started at Week 0 of the current extension study (SHP610-201=2014-003960-20), with a cumulative treatment period of up to 30 months (120 weeks).
10856036|NCT00333177|EG002|Reported Event|CT - Oral Ris|"Participants will receive cognitive remediation training plus risperidone administered orally.~Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.~Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist~Individual Placement and Support: Supported education/employment"
10856037|NCT00333177|EG003|Reported Event|HBT - Oral Ris|"Participants will receive health behavior training plus risperidone administered orally.~Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation.~Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist~Individual Placement and Support: Supported education/employment"
10856038|NCT00333359|BG000|Baseline|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856039|NCT00333359|BG001|Baseline|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856040|NCT00333359|BG002|Baseline|Total|Total of all reporting groups
10856041|NCT00333359|FG000|Participant Flow|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856042|NCT00333359|FG001|Participant Flow|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856043|NCT00333359|OG000|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856044|NCT00333359|OG001|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856045|NCT00333359|OG002|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856046|NCT00333359|EG000|Reported Event|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856047|NCT00333359|EG001|Reported Event|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856048|NCT00333359|EG002|Reported Event|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
10856049|NCT00333437|BG000|Baseline|Treatment|Study subjects receive standard mycophenolate dosing.
10856050|NCT00333437|FG000|Participant Flow|Single-group Study Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
10856051|NCT00333437|OG000|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
10856052|NCT00333437|OG000|Outcome|Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
10856053|NCT00333437|EG000|Reported Event|Treatment|Study subjects receive standard mycophenolate dosing.
10856054|NCT00333606|BG000|Baseline|Verum, Then Sham Acupuncture|verum acupuncture means stimulation of specific acupuncture points
10856055|NCT00333606|BG001|Baseline|Sham, Then Verum Acupuncture|Sham acupuncture means stimulation of non-specific points
10856056|NCT00333606|BG002|Baseline|Total|Total of all reporting groups
10856057|NCT00333606|FG000|Participant Flow|Sham, Then Verum Acupuncture|Stimulation was applied to sham acupuncture point
10856058|NCT00333606|FG001|Participant Flow|Verum, Then Sham Acupuncture|Stimulation was applied to verum acupuncture point
10856059|NCT00333606|OG000|Outcome|Verum Acupuncture|"Acupuncture of specific acupuncture points~Acupuncture: Body acupuncture of 1 specific point per trial session"
10856060|NCT00333606|OG001|Outcome|Sham Acupuncture|"Acupuncture of non-specific acupuncture points~Acupuncture: Body acupuncture of 1 specific point per trial session"
10856061|NCT00333606|OG000|Outcome|Sham Acupuncture|Sham acupuncture means stimulation of non-specific points
10856062|NCT00333606|OG001|Outcome|Verum Acupuncture|Acupuncture needles applied to specific acupuncture points
10856063|NCT00333606|EG000|Reported Event|Verum Acupuncture|verum acupuncture means stimulation of specific acupuncture points
10856064|NCT00333606|EG001|Reported Event|Sham Acupuncture|Sham acupuncture means stimulation of non-specific points
10856065|NCT00333619|BG000|Baseline|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
10856066|NCT00333619|BG001|Baseline|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
10856067|NCT00333619|BG002|Baseline|Total|Total of all reporting groups
10856068|NCT00333619|FG000|Participant Flow|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
10856069|NCT00333619|FG001|Participant Flow|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
10856070|NCT00333619|OG000|Outcome|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
10856071|NCT00333619|OG001|Outcome|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
10856072|NCT00333619|OG000|Outcome|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
10856073|NCT00333619|OG001|Outcome|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
10856074|NCT00333619|EG000|Reported Event|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
10856075|NCT00333619|EG001|Reported Event|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
10856076|NCT00333710|BG000|Baseline|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
10856077|NCT00333710|BG001|Baseline|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
10856078|NCT00333710|BG002|Baseline|Control Condition/Treatment as Usual|"Control condition/treatment as usual.~No active treatment"
10856079|NCT00333710|BG003|Baseline|Total|Total of all reporting groups
10856080|NCT00333710|FG000|Participant Flow|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
10856081|NCT00333710|FG001|Participant Flow|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
10856082|NCT00333710|FG002|Participant Flow|Control Condition/Treatment as Usual|Control condition/treatment as usual
10856083|NCT00333710|OG000|Outcome|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
10856084|NCT00333710|OG001|Outcome|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
10856085|NCT00333710|OG002|Outcome|Control Condition/Treatment as Usual|Control condition/treatment as usual
10856086|NCT00333710|EG000|Reported Event|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
10856087|NCT00333710|EG001|Reported Event|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
10856088|NCT00333710|EG002|Reported Event|Control Condition/Treatment as Usual|Control condition/treatment as usual
10856089|NCT00333775|BG000|Baseline|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856090|NCT00333775|BG001|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856091|NCT00333775|BG002|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856092|NCT00333775|BG003|Baseline|Total|Total of all reporting groups
10856093|NCT00333775|FG000|Participant Flow|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856094|NCT00333775|FG001|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856095|NCT00333775|FG002|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856096|NCT00333775|OG000|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856097|NCT00333775|OG001|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856098|NCT00333775|OG002|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856099|NCT00333775|EG000|Reported Event|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856100|NCT00333775|EG001|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856101|NCT00333775|EG002|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
10856102|NCT00333788|BG000|Baseline|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
10856103|NCT00333788|FG000|Participant Flow|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
10856104|NCT00333788|OG000|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
10856105|NCT00333788|EG000|Reported Event|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
10856106|NCT00333801|BG000|Baseline|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
10856107|NCT00333801|BG001|Baseline|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
10856108|NCT00333801|BG002|Baseline|Total|Total of all reporting groups
10856109|NCT00333801|FG000|Participant Flow|Vocational Rehabilitation Program (VRP)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
10856110|NCT00333801|FG001|Participant Flow|Individual Placement and Support (IPS)|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
10856111|NCT00333801|OG000|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
10856112|NCT00333801|OG001|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
10856113|NCT00333801|EG000|Reported Event|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
10856114|NCT00333801|EG001|Reported Event|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
10856115|NCT00333814|BG000|Baseline|Dexamethasone 350 µg|Dexamethasone 350 µg
10856116|NCT00333814|BG001|Baseline|Dexamethasone 700 µg|Dexamethasone 700 µg
10856117|NCT00333814|BG002|Baseline|Sham|Sham
10856118|NCT00333814|BG003|Baseline|Total|Total of all reporting groups
10856119|NCT00333814|FG000|Participant Flow|Dexamethasone 350 µg|Dexamethasone 350 µg
10856120|NCT00333814|FG001|Participant Flow|Dexamethasone 700 µg|Dexamethasone 700 µg
10856121|NCT00333814|FG002|Participant Flow|Sham|Sham
10856122|NCT00333814|OG000|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
10856123|NCT00333814|OG001|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
10856124|NCT00333814|OG002|Outcome|Sham|Sham
10856125|NCT00333814|EG000|Reported Event|Dexamethasone 350 µg|Dexamethasone 350 µg
10856126|NCT00333814|EG001|Reported Event|Dexamethasone 700 µg|Dexamethasone 700 µg
10856127|NCT00333814|EG002|Reported Event|Sham|Sham
10856128|NCT00333840|BG000|Baseline|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
10856129|NCT00333840|BG001|Baseline|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
10856130|NCT00333840|BG002|Baseline|Total|Total of all reporting groups
10856131|NCT00333840|FG000|Participant Flow|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
10856132|NCT00333840|FG001|Participant Flow|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
10856133|NCT00333840|FG002|Participant Flow|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
10856134|NCT00333840|FG003|Participant Flow|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
10856135|NCT00333840|OG000|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
10856136|NCT00333840|OG001|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
10856137|NCT00333840|OG001|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
10856138|NCT00333840|OG000|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
11223061|NCT02350816|OG003|Outcome|Group 3B|Participants in Group 3B were not treated in HGT-SAN-093 (NCT02350816) study. Participants received HGT-1410 treatment at a dose of 45mg administered intrathecally via IDDD Q4W started at Week 0 of the current extension study (SHP610-201=2014-003960-20), with a cumulative treatment period of up to 30 months (120 weeks).
11223062|NCT02350816|EG000|Reported Event|Group 1|Participants continued HGT-1410 treatment from HGT-SAN-093 (NCT02350816) study at a dose of 45 milligrams (mg) administered intrathecally (IT) via IT drug delivery device (IDDD) every 2 weeks (Q2W) started at Week 50, with a cumulative treatment period of up to 42 months (168 weeks).
10856139|NCT00333840|OG000|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
10856140|NCT00333840|OG001|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
10856141|NCT00333840|OG000|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 mu/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injection for 10 days every month in the second-line treatment period.
10856142|NCT00333840|OG000|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
10856143|NCT00333840|EG000|Reported Event|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
10856144|NCT00333840|EG001|Reported Event|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
10856145|NCT00333840|EG002|Reported Event|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
10856146|NCT00333840|EG003|Reported Event|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
10878897|NCT00454649|FG008|Participant Flow|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
10878898|NCT00454649|FG009|Participant Flow|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
10878899|NCT00454649|OG000|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
10878900|NCT00454649|OG001|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
11223063|NCT02350816|EG001|Reported Event|Group 2|Participants continued HGT-1410 treatment from HGT-SAN-093 (NCT02350816) study at a dose of 45 mg administered intrathecally IDDD every 4 weeks (Q4W) started at Week 52, with a cumulative treatment period of up to 42 months (168 weeks).
10856147|NCT00333866|BG000|Baseline|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
10856148|NCT00333866|BG001|Baseline|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
10856149|NCT00333866|BG002|Baseline|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
10856150|NCT00333866|BG003|Baseline|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
10856151|NCT00333866|BG004|Baseline|Total|Total of all reporting groups
10856152|NCT00333866|FG000|Participant Flow|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
10856153|NCT00333866|FG001|Participant Flow|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
10856154|NCT00333866|FG002|Participant Flow|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
10856155|NCT00333866|FG003|Participant Flow|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
10856156|NCT00333866|OG000|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
10856157|NCT00333866|OG001|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
10856158|NCT00333866|OG002|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
10856159|NCT00333866|OG003|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
10856160|NCT00333866|EG000|Reported Event|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
10856161|NCT00333866|EG001|Reported Event|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
10856162|NCT00333866|EG002|Reported Event|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
10856163|NCT00333866|EG003|Reported Event|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
10856164|NCT00333879|BG000|Baseline|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
10856165|NCT00333879|FG000|Participant Flow|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
10856166|NCT00333879|OG000|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
10856167|NCT00333879|EG000|Reported Event|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
10856168|NCT00333970|BG000|Baseline|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
10856169|NCT00333970|BG001|Baseline|Arm 2|treatment as usual
10856170|NCT00333970|BG002|Baseline|Total|Total of all reporting groups
11223064|NCT02350816|EG002|Reported Event|Group 3A|Participants in Group 3A were not treated in HGT-SAN-093 (NCT02350816) study. Participants received HGT-1410 treatment at a dose of 45mg administered intrathecally IDDD Q2W started at Week 0 of the current extension study (SHP610-201=2014-003960-20), with a cumulative treatment period of up to 30 months (120 weeks).
10856171|NCT00333970|FG000|Participant Flow|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
10856172|NCT00333970|FG001|Participant Flow|Arm 2|treatment as usual
10856173|NCT00333970|OG000|Outcome|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
10856174|NCT00333970|OG001|Outcome|Arm 2|treatment as usual
10856175|NCT00333970|EG000|Reported Event|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
10856176|NCT00333970|EG001|Reported Event|Arm 2|treatment as usual
10856177|NCT00333983|BG000|Baseline|Planar Robot|Robot-assisted planar reaching x 60 minutes.
10856178|NCT00333983|BG001|Baseline|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes.
10856179|NCT00333983|BG002|Baseline|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
10856180|NCT00333983|BG003|Baseline|Total|Total of all reporting groups
10856181|NCT00333983|FG000|Participant Flow|Planar Robot|Robot-assisted planar reaching x 60 minutes
10856182|NCT00333983|FG001|Participant Flow|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes
10856183|NCT00333983|FG002|Participant Flow|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes.
10856184|NCT00333983|OG000|Outcome|Planar Robot|Planar Robot Exercise x 60 minutes.
10856185|NCT00333983|OG001|Outcome|Planar + Vertical|Planar + Vertical Robot Exercise x 60 minutes.
10856186|NCT00333983|OG002|Outcome|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
10856187|NCT00333983|EG000|Reported Event|Planar Robot|Planar Robot Exercise Group
10856188|NCT00333983|EG001|Reported Event|Planar + Vertical Robot|Planar + Vertical Robot Exercise Group
10856189|NCT00333983|EG002|Reported Event|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion and arm ergometer training.
10856190|NCT00334061|BG000|Baseline|Penumbra System|
10856191|NCT00334061|FG000|Participant Flow|Penumbra System|
10856192|NCT00334061|OG000|Outcome|Penumbra System|
10856193|NCT00334061|EG000|Reported Event|Penumbra System|
10856194|NCT00334074|BG000|Baseline|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
10856195|NCT00334074|FG000|Participant Flow|Clofarabine and Cytarabine|5 consecutive days of Clofarabine 40 mg/m^2 intravenous infusion over 1 hour followed 4 hours later by cytarabine 1000mg/m^2 intravenous infusion over 2 hours.Next cycle will start approximately 4 weeks after Day 1 of previous cycle. Patients will receive a maximum of 4 cycles of study treatment.
10856196|NCT00334074|OG000|Outcome|Clofarabine Plus Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Four hours post clofarabine infusion,Give cytarabine 1000 mg/m2 IV infusion over 2 hours.Patients will receive a maximum upto 4 cycles of study treatment.Next cycle will start approximately 4 weeks after Day 1 of previous cycle.
10856197|NCT00334074|OG000|Outcome|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
10856198|NCT00334074|EG000|Reported Event|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 intravenous infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 intravenous infusion 4 hours post clofarabine IVI.
10856199|NCT00334113|BG000|Baseline|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.~Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
10856200|NCT00334113|BG001|Baseline|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
10856201|NCT00334113|BG002|Baseline|Total|Total of all reporting groups
10856202|NCT00334113|FG000|Participant Flow|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.~Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
10856203|NCT00334113|FG001|Participant Flow|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
10856204|NCT00334113|OG000|Outcome|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
10856205|NCT00334113|OG001|Outcome|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
10856206|NCT00334113|EG000|Reported Event|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
10856207|NCT00334113|EG001|Reported Event|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
10856208|NCT00334204|BG000|Baseline|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
10856209|NCT00334204|FG000|Participant Flow|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
10856210|NCT00334204|OG000|Outcome|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
10856211|NCT00334204|OG000|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
10856212|NCT00334204|EG000|Reported Event|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
10856213|NCT00334282|BG000|Baseline|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
10856214|NCT00334282|BG001|Baseline|Placebo|Matching Placebo administered once a day
10856215|NCT00334282|BG002|Baseline|Total|Total of all reporting groups
10856216|NCT00334282|FG000|Participant Flow|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
10856217|NCT00334282|FG001|Participant Flow|Placebo|Matching Placebo administered orally once a day
10856218|NCT00334282|OG000|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
10856219|NCT00334282|OG001|Outcome|Placebo|Matching Placebo administered once a day
10856220|NCT00334282|OG001|Outcome|Placebo|Matching Placebo administered orally once a day
10856221|NCT00334282|OG001|Outcome|Placebo|Matching placebo administered orally once a day
10856222|NCT00334282|OG000|Outcome|Pazopanib|Pazopanib 800 mg (tablets) administered orally once a day
10856223|NCT00334282|OG000|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered once daily
10856224|NCT00334282|EG000|Reported Event|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
10856225|NCT00334282|EG001|Reported Event|Placebo|Matching Placebo administered orally once a day
10856226|NCT00334295|BG000|Baseline|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
10856227|NCT00334295|FG000|Participant Flow|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
10856228|NCT00334295|OG000|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
10856229|NCT00334295|EG000|Reported Event|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
10856230|NCT00334542|BG000|Baseline|Simvastatin|Simvastatin 40 mg for 24-28 weeks
10856231|NCT00334542|FG000|Participant Flow|Simvastatin|Simvastatin 40 mg for 24-28 weeks
10856232|NCT00334542|OG000|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
10856233|NCT00334542|OG000|Outcome|Simvastatin|"Simvastatin 40 mg for 24-28 weeks~simvastatin: 24-28 weeks of simvastatin"
10856234|NCT00334542|EG000|Reported Event|Simvastatin|Simvastatin 40 mg for 24-28 weeks
10856235|NCT00334633|BG000|Baseline|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
10856236|NCT00334633|BG001|Baseline|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
10856237|NCT00334633|BG002|Baseline|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
10856238|NCT00334633|BG003|Baseline|Total|Total of all reporting groups
10856239|NCT00334633|FG000|Participant Flow|Metronidazole|metronidazole 500 twice a day (BID) for 7 days; 197 participants
10856240|NCT00334633|FG001|Participant Flow|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
10856241|NCT00334633|FG002|Participant Flow|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
10856242|NCT00334633|OG000|Outcome|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
10856243|NCT00334633|OG001|Outcome|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
10856244|NCT00334633|OG002|Outcome|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
10856245|NCT00334633|OG000|Outcome|Control|"metronidazole 500 BID for 7 days~tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid"
10856246|NCT00334633|OG001|Outcome|Tinidazole 500|"tinidazole 500 BID for 7 days~tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid"
10856247|NCT00334633|OG002|Outcome|Tinidazole 1 gm|"tinidazole 1 gm BID for 7 days~tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid"
10856248|NCT00334633|EG000|Reported Event|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
10856249|NCT00334633|EG001|Reported Event|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
10856250|NCT00334633|EG002|Reported Event|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
10856251|NCT00334737|BG000|Baseline|Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w|"Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks~darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks"
10856252|NCT00334737|BG001|Baseline|Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35|"Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks~erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation"
10856253|NCT00334737|BG002|Baseline|Placebo/Control|"Sham injection~sham injection: sham injection"
10856254|NCT00334737|BG003|Baseline|Total|Total of all reporting groups
10856255|NCT00334737|FG000|Participant Flow|Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w|"Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks~darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks"
10856256|NCT00334737|FG001|Participant Flow|Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35|"Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks~erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation"
10856257|NCT00334737|FG002|Participant Flow|Placebo/Control|"Sham injection~sham injection: sham injection"
10856258|NCT00334737|OG000|Outcome|Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w|"Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks~darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks"
10856259|NCT00334737|OG001|Outcome|Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35|"Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks~erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation"
10856260|NCT00334737|OG002|Outcome|Placebo/Control|"Sham injection~sham injection: sham injection"
10856261|NCT00334737|EG000|Reported Event|Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w|"Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks~darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks"
10856262|NCT00334737|EG001|Reported Event|Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35|"Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks~erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation"
10856263|NCT00334737|EG002|Reported Event|Placebo/Control|"Sham injection~sham injection: sham injection"
10856264|NCT00334802|BG000|Baseline|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856265|NCT00334802|BG001|Baseline|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856266|NCT00334802|BG002|Baseline|Total|Total of all reporting groups
10856267|NCT00334802|FG000|Participant Flow|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856268|NCT00334802|FG001|Participant Flow|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856269|NCT00334802|OG000|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856270|NCT00334802|OG001|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856271|NCT00334802|OG000|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856272|NCT00334802|OG000|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
10856273|NCT00334802|OG001|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
10856274|NCT00334802|EG000|Reported Event|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856275|NCT00334802|EG001|Reported Event|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
10856276|NCT00334893|BG000|Baseline|Platinum-Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
10856277|NCT00334893|BG001|Baseline|Platinum-Sensitive Cohort|Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856278|NCT00334893|BG002|Baseline|Total|Total of all reporting groups
10856279|NCT00334893|FG000|Participant Flow|Platinum Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
10856280|NCT00334893|FG001|Participant Flow|Platinum Sensitive Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
10856281|NCT00334893|OG000|Outcome|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
10856282|NCT00334893|OG001|Outcome|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
10856283|NCT00334893|OG000|Outcome|Platinum-Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
10856284|NCT00334893|OG001|Outcome|Platinum-Sensitive Cohort|Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856285|NCT00334893|EG000|Reported Event|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
10856286|NCT00334893|EG001|Reported Event|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
10856287|NCT00334958|BG000|Baseline|Rufinamide|For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
10856288|NCT00334958|BG001|Baseline|Placebo|For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
10856289|NCT00334958|BG002|Baseline|Total|Total of all reporting groups
10856290|NCT00334958|FG000|Participant Flow|Rufinamide|For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
10856291|NCT00334958|FG001|Participant Flow|Placebo|For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
10856292|NCT00334958|OG000|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
10856293|NCT00334958|OG001|Outcome|Placebo|For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
10856294|NCT00334958|EG000|Reported Event|Rufinamide|For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
10856295|NCT00334958|EG001|Reported Event|Placebo|For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
10856296|NCT00335140|BG000|Baseline|Rituximab + Standard Chemotherapy|"rituximab~cytarabine~dexamethasone~leucovorin calcium~methotrexate~procarbazine hydrochloride~vincristine sulfate"
10856297|NCT00335140|FG000|Participant Flow|Rituximab + Standard Chemotherapy|"rituximab~cytarabine~dexamethasone~leucovorin calcium~methotrexate~procarbazine hydrochloride~vincristine sulfate"
10856298|NCT00335140|OG000|Outcome|Rituximab + Standard Chemotherapy|"rituximab~cytarabine~dexamethasone~leucovorin calcium~methotrexate~procarbazine hydrochloride~vincristine sulfate"
10856299|NCT00335140|EG000|Reported Event|Rituximab + Standard Chemotherapy|Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
10856300|NCT00335153|BG000|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
10856301|NCT00335153|FG000|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
10856302|NCT00335153|OG000|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
10878901|NCT00454649|OG002|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10856303|NCT00335153|EG000|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
10856304|NCT00335257|BG000|Baseline|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen )
10856305|NCT00335257|BG001|Baseline|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
10856306|NCT00335257|BG002|Baseline|OCs Non-DRSP|Users of OCs containing other progestins
10856307|NCT00335257|BG003|Baseline|Total|Total of all reporting groups
10856308|NCT00335257|FG000|Participant Flow|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen)
10856309|NCT00335257|FG001|Participant Flow|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
10856310|NCT00335257|FG002|Participant Flow|OCs Non-DRSP|Users of OCs containing other progestins
10856311|NCT00335257|OG000|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
10856312|NCT00335257|OG001|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
10856313|NCT00335257|OG002|Outcome|OCs Non-DRSP|Users of OCs containing other progestins than DRSP
10856314|NCT00335257|OG003|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
10856315|NCT00335257|OG004|Outcome|No Use|No (hormonal) contraception at last contact
10856316|NCT00335257|OG002|Outcome|OCs Non-DRSP|Users of OCs containing other progestins
10856317|NCT00335257|OG004|Outcome|No Use|No (hormonal) contraception
10856318|NCT00335257|EG000|Reported Event|DRSP-24d|24-day regimen of DRSP/EE
10856319|NCT00335257|EG001|Reported Event|DRSP-21d|21-day regimen of DRSP/EE
10856320|NCT00335257|EG002|Reported Event|OCs Non-DRSP|Users of OCs containing other progestins
10856321|NCT00335257|EG003|Reported Event|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or patches)
10856322|NCT00335257|EG004|Reported Event|No Use|No (hormonal) contraception)
10856323|NCT00335283|BG000|Baseline|Lansoprazole|40 mg twice a day
10856324|NCT00335283|BG001|Baseline|Placebo (Sugar Pill)|one tablet twice a day
10856325|NCT00335283|BG002|Baseline|Total|Total of all reporting groups
10856326|NCT00335283|FG000|Participant Flow|Lansoprazole|40 mg twice a day
10856327|NCT00335283|FG001|Participant Flow|Placebo (Sugar Pill)|one tablet twice a day
10856328|NCT00335283|OG000|Outcome|Lansoprazole|40 mg twice a day
10856329|NCT00335283|OG001|Outcome|Placebo (Sugar Pill)|one tablet twice a day
10856330|NCT00335283|EG000|Reported Event|Lansoprazole|40 mg twice a day
10856331|NCT00335283|EG001|Reported Event|Placebo (Sugar Pill)|one tablet twice a day
10856332|NCT00335322|BG000|Baseline|TDF/FTC+EFV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ Stocrin efavirenz
10856333|NCT00335322|BG001|Baseline|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
10856334|NCT00335322|BG002|Baseline|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
10856335|NCT00335322|BG003|Baseline|Total|Total of all reporting groups
10856336|NCT00335322|FG000|Participant Flow|TDF/FTC+EFV|Truvada (fixed dose combination of tenofovir+emtricitabine) + Stocrin efavirenz
10856337|NCT00335322|FG001|Participant Flow|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
10856338|NCT00335322|FG002|Participant Flow|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
10856339|NCT00335322|OG000|Outcome|TDF/FTC+EFV|"Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)~Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily"
10856340|NCT00335322|OG001|Outcome|TDF/FTC+r/ATV|"Truvada (fixed dose combination of tenofovir + emtricitabine) + ritonavir/atazanavir (r/ATV)~Truvada (tenofovir 300mg qd + 200mg qd) once daily Ritonavir/atazanavi 100mg/300mg qd once daily"
10856341|NCT00335322|OG002|Outcome|TDF/FTC+AZT+ABC|"Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine + abacavir~Truvada (tenofovir 300mg qd + 200mg qd) once daily Zidovudine 250mg/300mg qd taken in two equal doses approx. 12 hours apart Abacavir 600mg qd"
10856342|NCT00335322|OG000|Outcome|TDF/FTC+EFV|Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz): Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily
10856343|NCT00335322|OG001|Outcome|TDF/FTC+ r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV): Tuvada (tenofovir 300mg qd + 200mg qd) once daily ritoanvir/atazanavir 100mg/300mg qd once daily (taken with food)
10856344|NCT00335322|OG002|Outcome|TDF/FTC + AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC): Tuvada (tenofovir 300mg qd + 200mg qd) once daily zidovudine 250mg/300mg qd (taken in two equal doses approximately 12 hours apart) Abacavir 600mg qd
10856345|NCT00335322|EG000|Reported Event|TDF/FTC+EFV|
10856346|NCT00335322|EG001|Reported Event|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
10856347|NCT00335322|EG002|Reported Event|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
10856348|NCT00335452|BG000|Baseline|Clopidogrel 300/75/75 mg + ASA Low Dose|
10856349|NCT00335452|BG001|Baseline|Clopidogrel 300/75/75 mg + ASA High Dose|
10856350|NCT00335452|BG002|Baseline|Clopidogrel 600/150/75 mg + ASA Low Dose|
10856351|NCT00335452|BG003|Baseline|Clopidogrel 600/150/75 mg + ASA High Dose|
10856352|NCT00335452|BG004|Baseline|Total|Total of all reporting groups
10856353|NCT00335452|FG000|Participant Flow|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
11126311|NCT00145158|EG000|Reported Event|Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).
10856354|NCT00335452|FG001|Participant Flow|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
10856355|NCT00335452|FG002|Participant Flow|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
10856356|NCT00335452|FG003|Participant Flow|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
10856357|NCT00335452|OG000|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
10856358|NCT00335452|OG001|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
10856359|NCT00335452|OG001|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose.
10856360|NCT00335452|OG000|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
10856361|NCT00335452|OG001|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
10856362|NCT00335452|OG000|Outcome|Clopidogrel 300/75/75 mg + ASA Low Dose|
10856363|NCT00335452|OG001|Outcome|Clopidogrel 300/75/75 mg + ASA High Dose|
10856364|NCT00335452|OG002|Outcome|Clopidogrel 600/150/75 mg + ASA Low Dose|
10856365|NCT00335452|OG003|Outcome|Clopidogrel 600/150/75 mg + ASA High Dose|
10856366|NCT00335452|EG000|Reported Event|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
10856367|NCT00335452|EG001|Reported Event|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
10856368|NCT00335452|EG002|Reported Event|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
10856369|NCT00335452|EG003|Reported Event|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
10856370|NCT00335478|BG000|Baseline|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
10856371|NCT00335478|FG000|Participant Flow|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
10856372|NCT00335478|OG000|Outcome|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
10856373|NCT00335478|EG000|Reported Event|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
10856374|NCT00335504|BG000|Baseline|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
10856375|NCT00335504|BG001|Baseline|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
10856376|NCT00335504|BG002|Baseline|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
10856377|NCT00335504|BG003|Baseline|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
10856378|NCT00335504|BG004|Baseline|Total|Total of all reporting groups
10856379|NCT00335504|FG000|Participant Flow|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
10856380|NCT00335504|FG001|Participant Flow|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
10856381|NCT00335504|FG002|Participant Flow|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
10856382|NCT00335504|FG003|Participant Flow|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
10856383|NCT00335504|OG000|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
10856384|NCT00335504|OG001|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
10856385|NCT00335504|OG002|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
10856386|NCT00335504|OG003|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
10856387|NCT00335504|EG000|Reported Event|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
10856388|NCT00335504|EG001|Reported Event|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
10856389|NCT00335504|EG002|Reported Event|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
10856390|NCT00335504|EG003|Reported Event|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
10856391|NCT00335517|BG000|Baseline|Injection|DepoDur Injection
10856392|NCT00335517|FG000|Participant Flow|Injection|DepoDur Injection
10856393|NCT00335517|OG000|Outcome|Injection|DepoDur Injection
10856394|NCT00335517|EG000|Reported Event|Injection|DepoDur Injection
10856395|NCT00335556|BG000|Baseline|Surgery|Surgery Only
10856396|NCT00335556|BG001|Baseline|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
10856397|NCT00335556|BG002|Baseline|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
10856398|NCT00335556|BG003|Baseline|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
10856399|NCT00335556|BG004|Baseline|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
10856400|NCT00335556|BG005|Baseline|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
10856401|NCT00335556|BG006|Baseline|Total|Total of all reporting groups
10856402|NCT00335556|FG000|Participant Flow|Surgery|Surgery Only
10845577|NCT00267748|FG000|Participant Flow|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
10845578|NCT00267748|FG001|Participant Flow|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
10845579|NCT00267748|FG002|Participant Flow|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
10856403|NCT00335556|FG001|Participant Flow|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
10856404|NCT00335556|FG002|Participant Flow|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
10856405|NCT00335556|FG003|Participant Flow|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
10856406|NCT00335556|FG004|Participant Flow|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
10856407|NCT00335556|FG005|Participant Flow|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
10856408|NCT00335556|OG000|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
10856409|NCT00335556|OG001|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
10856410|NCT00335556|OG002|Outcome|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
10856411|NCT00335556|OG000|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphamide; x 30 weeks; XRT.
10856412|NCT00335556|OG000|Outcome|Combined Window/UH-1 and UH-2|Combine window/UH-1 and UH-2 for response rate monitoring for window therapy.
11223065|NCT02350816|EG003|Reported Event|Group 3B|Participants in Group 3B were not treated in HGT-SAN-093 (NCT02350816) study. Participants received HGT-1410 treatment at a dose of 45mg administered intrathecally via IDDD Q4W started at Week 0 of the current extension study (SHP610-201=2014-003960-20), with a cumulative treatment period of up to 30 months (120 weeks).
11223066|NCT02350881|BG000|Baseline|Overall Cohort|one consecutive series of patients were included
10856413|NCT00335556|OG000|Outcome|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
10856414|NCT00335556|OG000|Outcome|Combined UH-2, UH-1, Window/UH-1|Combined UH-1, UH-2, and Window/UH-1 for revised-UH toxicity monitoring
10856415|NCT00335556|OG000|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide;x 30 weeks; XRT.
10856416|NCT00335556|OG001|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
10856417|NCT00335556|OG002|Outcome|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
10856418|NCT00335556|OG003|Outcome|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
10856419|NCT00335556|EG000|Reported Event|Surgery|Surgery Only
10856420|NCT00335556|EG001|Reported Event|UH-1|Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT
10856421|NCT00335556|EG002|Reported Event|Window/UH-1|"Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT"
10856422|NCT00335556|EG003|Reported Event|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
10856423|NCT00335556|EG004|Reported Event|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT
10856424|NCT00335556|EG005|Reported Event|Regimen DD-4A|"Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"
10856425|NCT00335725|BG000|Baseline|Fostimon|
10856426|NCT00335725|BG001|Baseline|Gonal-f|
10856427|NCT00335725|BG002|Baseline|Total|Total of all reporting groups
10856428|NCT00335725|FG000|Participant Flow|Fostimon|Highly purified FSH
10856429|NCT00335725|FG001|Participant Flow|Gonal-f|Recombinant FSH
10856430|NCT00335725|OG000|Outcome|Fostimon|
10856431|NCT00335725|OG001|Outcome|Gonal-f|
10856432|NCT00335725|OG001|Outcome|Gonal-F|
10856433|NCT00335725|EG000|Reported Event|Fostimon|
10856434|NCT00335725|EG001|Reported Event|Gonal-F|
10856435|NCT00335738|BG000|Baseline|Group 1 (High Risk)|"Patients receive liposomal vincristine sulfate IV aged based dosage (Pts < 36 mos: 0.05 mg/kg, Pts > 36 mos: 1.5 mg/m2, max dose 2 MG) given IV or infusion on day 1, carboplatin aged based dosage (Pts < 36 mos: 18.6 mg/kg Pts > 36 mos: 560 mg/m2) IV on day 1, and Etoposide aged based dosage (Pts < 36 mos: 5 mg/kg, Pts > 36 mos: 150 mg/m2) IV on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~liposomal vincristine sulfate: Given IV~carboplatin: Given IV~etoposide: Given IV"
10856436|NCT00335738|BG001|Baseline|Group 2 (Not High Risk)|Patients undergo observation periodically for at least 5 years.
10856437|NCT00335738|BG002|Baseline|Total|Total of all reporting groups
10856438|NCT00335738|FG000|Participant Flow|Group 1 (Identified by Central Review as High Risk)|Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
10856439|NCT00335738|FG001|Participant Flow|Group 2 (Identified by Central Review as Not High Risk)|Patients undergo observation periodically for at least 5 years.
10856440|NCT00335738|OG000|Outcome|Group 1 (Identified by Central Review as High Risk)|Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
10856441|NCT00335738|OG001|Outcome|Group 2 (Identified by Central Review as Not High Risk)|Patients undergo observation periodically for at least 5 years.
10856442|NCT00335738|OG000|Outcome|All Patients|This outcome measure is calculated by combining all groups as defined in the trials record.
11223067|NCT02350881|FG000|Participant Flow|Overall Cohort|one consecutive series of patients were included
11223068|NCT02350881|OG000|Outcome|Overall Cohort|one consecutive series of patients were included
10845580|NCT00267748|OG000|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
10845581|NCT00267748|OG001|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
11223069|NCT02350881|OG000|Outcome|Absent|Number of patients reporting no pain
11223070|NCT02350881|OG001|Outcome|Moderate|Number of patients reporting a moderate pain
11223071|NCT02350881|OG002|Outcome|Severe|Number of patients reporting a severe pain
11223072|NCT02350881|OG000|Outcome|Absence|Number of feet where no osteolysis was observed
10856443|NCT00335738|EG000|Reported Event|Group 1 (Identified by Central Review as High Risk)|Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
10856444|NCT00335738|EG001|Reported Event|Group 2 (Identified by Central Review as Not High Risk)|Patients undergo observation periodically for at least 5 years.
10856445|NCT00335764|BG000|Baseline|Group 1 Phase I Sorafenib and Erlotinib|"Patients receive oral sorafenib tosylate twice daily and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
10856446|NCT00335764|BG001|Baseline|Group 2 Phase I Sorafenib and Temsirolimus|"Patients receive sorafenib tosylate as in group 2. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally~temsirolimus: IV administration"
10856447|NCT00335764|BG002|Baseline|Group 3 Phase I Sorafenib and Tipifarnib|"Patients receive sorafenib tosylate as in group 3. Patients also receive oral tipifarnib twice daily on days 1-21.~sorafenib tosylate: given orally~tipifarnib: given orally"
10856448|NCT00335764|BG003|Baseline|Group 1 Phase II Sorafenib and Erlotinib|"Patients receive oral sorafenib tosylate twice daily and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
10856449|NCT00335764|BG004|Baseline|Group 2 Phase II Sorafenib and Temsirolimus|"Patients receive sorafenib tosylate 400 mg BID as in group 2. Patients also receive temsirolimus IV 25 mg over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally~temsirolimus: IV administration"
10856450|NCT00335764|BG005|Baseline|Total|Total of all reporting groups
10856451|NCT00335764|FG000|Participant Flow|Group 1 Phase I Sorafenib and Erlotinib|"Patients receive oral sorafenib tosylate BID and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally Dose Level 0: 200mg BID (fixed) Dose Level 1: 400mg BID (fixed)~erlotinib hydrochloride: given orally Dose Level 0: 100mg QD Dose Level 1: 100mg QD Dose Level 2: 150mg QD"
10856452|NCT00335764|FG001|Participant Flow|Group 2 Phase I Sorafenib and Temsirolimus|"Patients receive sorafenib tosylate BID as in group 2. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally Dose Level 0: 200mg BID Dose Level 1: 400mg BID~temsirolimus: IV administration Dose Level 0: 25mg IV QW Dose Level 1: 25mg IV QW Dose Level 2: 50mg IV QW Dose Level 3: 75mg IV QW Dose Level 4: 125mg IV QW Dose Level 5: 175mg IV QW"
10856453|NCT00335764|FG002|Participant Flow|Group 3 Phase I Sorafenib and Tipifarnib|"Patients receive sorafenib tosylate BID as in group 3. Patients also receive oral tipifarnib twice daily on days 1-21.~sorafenib tosylate: given orally Dose Level 0: 200mg BID Dose Level 1: 400mg BID~tipifarnib: given orally Dose Level 0: 100mg BID Dose Level 1: 100mg BID Dose Level 2: 200mg BID Dose Level 3: 300mg BID"
10856454|NCT00335764|FG003|Participant Flow|Group 1 Phase II Sorafenib and Erlotinib|"Patients receive oral sorafenib tosylate BID and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
10856455|NCT00335764|FG004|Participant Flow|Group 2 Phase II Sorafenib and Temsirolimus|"Patients receive sorafenib tosylate BID as in group 2. Patients also receive temsirolimus IV 25 mg over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally 400mg BID~temsirolimus: IV administration 25mg IV QW"
10856456|NCT00335764|OG000|Outcome|Group 1 Phase I Sorafenib and Erlotinib QD|"Patients receive oral sorafenib tosylate BID and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally Dose Level 0: 200mg BID (fixed) Dose Level 1: 400mg BID (fixed)~erlotinib hydrochloride: given orally Dose Level 0: 100mg QD Dose Level 1: 100mg QD Dose Level 2: 150mg QD"
10856457|NCT00335764|OG001|Outcome|Group 2 Phase I Sorafenib and Temsirolimus QW|"Patients receive sorafenib tosylate BID as in group 2. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally Dose Level 0: 200mg BID Dose Level 1: 400mg BID~temsirolimus: IV administration Dose Level 0: 25mg IV QW Dose Level 1: 25mg IV QW Dose Level 2: 50mg IV QW Dose Level 3: 75mg IV QW Dose Level 4: 125mg IV QW Dose Level 5: 175mg IV QW"
10856458|NCT00335764|OG002|Outcome|Group 3 Phase I Sorafenib and Tipifarnib BID|"Patients receive sorafenib tosylate BID as in group 3. Patients also receive oral tipifarnib twice daily on days 1-21.~sorafenib tosylate: given orally Dose Level 0: 200mg BID Dose Level 1: 400mg BID~tipifarnib: given orally Dose Level 0: 100mg BID Dose Level 1: 100mg BID Dose Level 2: 200mg BID Dose Level 3: 300mg BID"
10856459|NCT00335764|OG000|Outcome|Group 2 Phase I Temsirolimus 25mg QW|"Pt receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Patients receive sorafenib tosylate BID.~sorafenib tosylate: given orally~temsirolimus: IV administration 25mg"
10856460|NCT00335764|OG001|Outcome|Group 2 Phase I Sorafenib 200mg BID|"Patients receive sorafenib tosylate BID 200mg. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally 200mg~temsirolimus: IV administration 25mg"
10856461|NCT00335764|OG002|Outcome|Group 2 Phase I Sorafenib 400mg BID|"Patients receive sorafenib tosylate BID 400mg. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally 400mg~temsirolimus: IV administration 25mg"
10856462|NCT00335764|OG000|Outcome|Group 1 Phase I Erlotinib 100mg QD|"Patients receive oral oral erlotinib hydrochloride 100 mg once daily on days 1-28. Pts also receive Sorafenib tosylate BID~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
10856463|NCT00335764|OG001|Outcome|Group 1 Phase I Sorafenib 200mg BID|"Patients receive oral sorafenib tosylate BID 200mg oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally 200mg~erlotinib hydrochloride: given orally"
10856464|NCT00335764|OG002|Outcome|Group 1 Phase I Sorafenib 400mg BID|"Patients receive oral sorafenib tosylate BID 400mg and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally 400mg~erlotinib hydrochloride: given orally"
10856465|NCT00335764|OG000|Outcome|Group 1 Phase I Erlotinib 100mg QD|"Patients receive oral erlotinib hydrochloride 100 mg once daily on days 1-28.And also oral sorafenib tosylate BID~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
11223073|NCT02350881|OG001|Outcome|Presence|Number of feet where osteolysis was observed
10856466|NCT00335764|OG001|Outcome|Group 1 Phase I Sorafenib 200mg|"Patients receive oral sorafenib tosylate BID 200mg and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally 200mg~erlotinib hydrochloride: given orally"
10856467|NCT00335764|OG002|Outcome|Group 1 Phase I Sorafenib 400mg|"Patients receive oral sorafenib tosylate BID 400mg and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally 400mg~erlotinib hydrochloride: given orally"
10856468|NCT00335764|OG000|Outcome|Group 2 Phase I Sorafenib and Temsirolimus QW|"Patients receive sorafenib tosylate BID Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally~temsirolimus: IV administration"
10856469|NCT00335764|OG000|Outcome|Group 2 Phase I Temsirolimus 25mg QW|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive sorafenib tosylate BID~sorafenib tosylate: given orally Dose Level 0: 200mg BID Dose Level 1: 400mg BID~temsirolimus: IV administration Dose Level 0: 25mg IV QW Dose Level 1: 25mg IV QW"
10856470|NCT00335764|OG001|Outcome|Group 2 Phase I Sorafenib 200mg|"Patients receive sorafenib tosylate BID Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally Dose Level 0: 200mg BID~temsirolimus: IV administration Dose Level 0: 25mg IV QW Dose Level 1: 25mg IV QW"
10856471|NCT00335764|OG002|Outcome|Group 2 Phase I Sorafenib 400mg|"Patients receive sorafenib tosylate BID Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally Dose Level 1: 400mg BID~temsirolimus: IV administration Dose Level 0: 25mg IV QW Dose Level 1: 25mg IV QW"
10856472|NCT00335764|OG000|Outcome|Group 3 Phase I Tipifarnib 100mg QD|"Patients receive oral tipifarnib every day on days 1-21. Patients also receive sorafenib tosylate BID~sorafenib tosylate: given orally Dose Level 0: 200mg BID~tipifarnib: given orally Dose level -1: 100mg QD"
10856473|NCT00335764|OG001|Outcome|Group 3 Phase I Sorafenib 200mg BID|"Patients receive sorafenib tosylate BID Patients also receive oral tipifarnib every day on days 1-21.~sorafenib tosylate: given orally Dose Level 0: 200mg BID~tipifarnib: given orally Dose level -1: 100mg QD"
10856474|NCT00335764|OG000|Outcome|Group 3 Phase I Tipifarnib 100mg BID|"Patients receive oral tipifarnib 100mg twice daily on days 2-21. Patients also sorafenib tosylate BID 200mg~sorafenib tosylate: given orally Dose Level 0: 200mg BID~tipifarnib: given orally Dose Level 1: 100mg BID"
10856475|NCT00335764|OG001|Outcome|Group 3 Phase I Sorafenib 200mg BID|"Patients receive oral tipifarnib 100mg twice daily on days 2-21. Patients also sorafenib tosylate BID 200mg~sorafenib tosylate: given orally Dose Level 0: 200mg BID~tipifarnib: given orally Dose Level 1: 100mg BID"
10856476|NCT00335764|OG000|Outcome|Group 3 Phase I Tipifarnib 100mg QD|"Patients receive oral tipifarnib 100mg twice daily on days 1-21. also receive sorafenib tosylate BID100mg~sorafenib tosylate: given orally Dose Level 0: 200mg BID~tipifarnib: given orally Dose Level -1: 100mg QD"
10856477|NCT00335764|OG001|Outcome|Group 3 Phase I Sorafenib 200mg BID|"Patients receive sorafenib tosylate BID100mgal and also tipifarnib 100mg QD on days 1-21.sorafenib tosylate: given orally Dose Level 0: 200mg BID~tipifarnib: given orally Dose Level -1: 100mg QD"
10856478|NCT00335764|OG000|Outcome|Group 3 Phase I Tipifarnib 100mg QD|"Patients receive oral tipifarnib twice daily on days 1-21. Patients also receive sorafenib tosylate BID 200 mg starting on day 2~sorafenib tosylate: given orally Dose Level 0: 200mg BID~tipifarnib: given orally Dose Level 1: 100mg BID"
10856479|NCT00335764|OG001|Outcome|Group 3 Phase I Sorefenib 200mg BID|"Patients also receive sorafenib tosylate BID 200 mg starting on day 2. Patients receive oral tipifarnib twice daily on days 1-21.~sorafenib tosylate: given orally Dose Level 0: 200mg BID~tipifarnib: given orally Dose Level 1: 100mg BID"
10856480|NCT00335764|OG000|Outcome|Group 1 Phase II Sorafenib and Erlotinib|"Patients receive oral sorafenib tosylate BID and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
10856481|NCT00335764|OG001|Outcome|Group 2 Phase II Sorafenib and Temsirolimus|"Patients receive sorafenib tosylate BID as in group 2. Patients also receive temsirolimus IV 25 mg over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally~temsirolimus: IV administration"
10856482|NCT00335764|OG000|Outcome|Group 1 Phase I Sorafenib and Erlotinib QD|"Patients receive oral sorafenib tosylate BID and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
10856483|NCT00335764|OG001|Outcome|Group 2 Phase I Sorafenib and Temsirolimus QW|"Patients receive sorafenib tosylate BID as in group 2. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally~temsirolimus: IV administration"
10856484|NCT00335764|OG002|Outcome|Group 3 Phase I Sorafenib and Tipifarnib BID|"Patients receive sorafenib tosylate BID as in group 3. Patients also receive oral tipifarnib twice daily on days 1-21.~sorafenib tosylate: given orally~tipifarnib: given orally"
10856485|NCT00335764|EG000|Reported Event|Group 1 Phase I Sorafenib and Erlotinib|"Patients receive oral sorafenib tosylate twice daily and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
10856486|NCT00335764|EG001|Reported Event|Group 2 Phase I Sorafenib and Temsirolimus|"Patients receive sorafenib tosylate as in group 2. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally~temsirolimus: IV administration"
10856487|NCT00335764|EG002|Reported Event|Group 3 Phase I Sorafenib and Tipifarnib|"Patients receive sorafenib tosylate as in group 3. Patients also receive oral tipifarnib twice daily on days 1-21.~sorafenib tosylate: given orally~tipifarnib: given orally"
10856488|NCT00335764|EG003|Reported Event|Group 1 Phase II Sorafenib and Erlotinib|"Patients receive oral sorafenib tosylate twice daily and oral erlotinib hydrochloride once daily on days 1-28.~sorafenib tosylate: given orally~erlotinib hydrochloride: given orally"
10856489|NCT00335764|EG004|Reported Event|Group 2 Phase II Sorafenib and Temsirolimus|"Patients receive sorafenib tosylate 400 mg BID as in group 2. Patients also receive temsirolimus IV 25 mg over 30 minutes on days 1, 8, 15, and 22.~sorafenib tosylate: given orally~temsirolimus: IV administration"
10856490|NCT00335829|BG000|Baseline|Single Arm, Received Bevacizumab and TACE|"bevacizumab~chemotherapy~embolization therapy~hepatic artery infusion"
10856491|NCT00335829|FG000|Participant Flow|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
10856492|NCT00335829|OG000|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
10856493|NCT00335829|EG000|Reported Event|Single Arm, Received Bevacizumab and TACE|"bevacizumab~chemotherapy~embolization therapy~hepatic artery infusion"
10856494|NCT00335959|BG000|Baseline|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
10856495|NCT00335959|FG000|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
10856496|NCT00335959|OG000|Outcome|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
10856497|NCT00335959|OG000|Outcome|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
10856498|NCT00335959|EG000|Reported Event|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
10856499|NCT00335972|BG000|Baseline|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
10856500|NCT00335972|BG001|Baseline|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
10856501|NCT00335972|BG002|Baseline|Total|Total of all reporting groups
10856502|NCT00335972|FG000|Participant Flow|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
10856503|NCT00335972|FG001|Participant Flow|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
10856504|NCT00335972|OG000|Outcome|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
10856505|NCT00335972|OG001|Outcome|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
10856506|NCT00335972|EG000|Reported Event|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
10878902|NCT00454649|OG003|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
10856507|NCT00335972|EG001|Reported Event|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
10856508|NCT00336024|BG000|Baseline|Arm I (Patients Treated Without Methotrexate (MTX))|"Patients receive vincristine sulfate IV on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3. Treatment repeats every 3 weeks for 3 courses.~Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity."
10878903|NCT00454649|OG004|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
10878904|NCT00454649|OG005|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
11098874|NCT01578551|OG001|Outcome|Arm B|"Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle. Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy~Bevacizumab: All patients will receive the drug at 15 mg/kg every 21 days, given immediately after completion of chemotherapy, starting with Cycle 1. After induction chemotherapy is completed (4 cycles), bevacizumab will continue at 15 mg/kg every 21 days until PD (provided neither PD nor toxicity requiring discontinuation has occurred) measured from date of first dose of bevacizumab."
11098875|NCT01578551|OG000|Outcome|Arm A|"Metformin starting at a dose of 500 mg twice a day, orally with meals. After one week, increase the dose of metformin to 1000 mg as the first dose of the day and 500 mg as the second dose. After another week, increase to 1000 mg of metformin two times a day. Metformin treatment will be initiated one week before beginning chemotherapy, if possible, but chemotherapy will not be delayed for metformin loading.~Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle.~Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy~Bevacizumab: 15 mg/kg every 21 days,"
11098876|NCT01578551|EG000|Reported Event|Arm A|"Metformin starting at a dose of 500 mg twice a day, orally with meals. After one week, increase the dose of metformin to 1000 mg as the first dose of the day and 500 mg as the second dose. After another week, increase to 1000 mg of metformin two times a day. Metformin treatment will be initiated one week before beginning chemotherapy, if possible, but chemotherapy will not be delayed for metformin loading.~Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle.~Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Bevacizumab: 15 mg/kg every 21 days, Metformin: 1000 mg twice daily with food."
11098877|NCT01578551|EG001|Reported Event|Arm B|"Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle.~Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days~Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy~Bevacizumab: All patients will receive the drug at 15 mg/kg every 21 days, given immediately after completion of chemotherapy, starting with Cycle 1. After induction chemotherapy is completed (4 cycles), bevacizumab will continue at 15 mg/kg every 21 days until PD (provided neither PD nor toxicity requiring discontinuation has occurred) measured from date of first dose of bevacizumab."
11098878|NCT01578577|BG000|Baseline|Standard Care|This arm will serve as a control group and will not receive any intervention.
11098879|NCT01578577|BG001|Baseline|EHMI|Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.
11098880|NCT01578577|BG002|Baseline|Nurse Educator + EHMI|Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.
11098881|NCT01578577|BG003|Baseline|Total|Total of all reporting groups
11098882|NCT01578577|FG000|Participant Flow|Standard Care|This arm will serve as a control group and will not receive any intervention.
10856509|NCT00336024|BG001|Baseline|Arm II (Patients Treated With MTX)|"Patients receive vincristine sulfate IV on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Treatment repeats every 3 weeks for 3 courses.~Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity."
10856510|NCT00336024|BG002|Baseline|Total|Total of all reporting groups
10856511|NCT00336024|FG000|Participant Flow|Arm I (Patients Treated Without Methotrexate (MTX))|"Patients receive vincristine sulfate IV on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3. Treatment repeats every 3 weeks for 3 courses.~Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity."
10856512|NCT00336024|FG001|Participant Flow|Arm II (Patients Treated With MTX)|"Patients receive vincristine sulfate IV on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Treatment repeats every 3 weeks for 3 courses.~Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity."
10856513|NCT00336024|OG000|Outcome|Arm I (Patients Treated Without Methotrexate (MTX))|"Patients receive vincristine sulfate IV on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3. Treatment repeats every 3 weeks for 3 courses.~Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity."
10856514|NCT00336024|OG001|Outcome|Arm II (Patients Treated With MTX)|"Patients receive vincristine sulfate IV on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Treatment repeats every 3 weeks for 3 courses.~Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity."
10856515|NCT00336024|EG000|Reported Event|Arm I (Patients Treated Without Methotrexate (MTX))|"Patients receive vincristine sulfate IV on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3. Treatment repeats every 3 weeks for 3 courses.~Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity."
10856516|NCT00336024|EG001|Reported Event|Arm II (Patients Treated With MTX)|"Patients receive vincristine sulfate IV on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Treatment repeats every 3 weeks for 3 courses.~Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity."
10856517|NCT00336232|BG000|Baseline|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
10856518|NCT00336232|FG000|Participant Flow|Vitamin K Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
10856519|NCT00336232|OG000|Outcome|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
10856520|NCT00336232|EG000|Reported Event|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
10856521|NCT00336284|BG000|Baseline|Home Monitoring|Home Monitoring programmed ON
10856522|NCT00336284|BG001|Baseline|Conventional|Home Monitoring programmed OFF
10856523|NCT00336284|BG002|Baseline|Total|Total of all reporting groups
10856524|NCT00336284|FG000|Participant Flow|Home Monitoring|Home Monitoring programmed ON
10856525|NCT00336284|FG001|Participant Flow|Conventional|Home Monitoring programmed OFF
10856526|NCT00336284|OG000|Outcome|Home Monitoring|Home Monitoring programmed ON
10856527|NCT00336284|OG001|Outcome|Conventional|Home Monitoring programmed OFF
10856528|NCT00336284|EG000|Reported Event|Home Monitoring|Home Monitoring programmed ON
10856529|NCT00336284|EG001|Reported Event|Conventional|Home Monitoring programmed OFF
10856530|NCT00336323|BG000|Baseline|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
10856531|NCT00336323|BG001|Baseline|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856532|NCT00336323|BG002|Baseline|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856533|NCT00336323|BG003|Baseline|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
10856534|NCT00336323|BG004|Baseline|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
10856535|NCT00336323|BG005|Baseline|Total|Total of all reporting groups
10856536|NCT00336323|FG000|Participant Flow|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
10856537|NCT00336323|FG001|Participant Flow|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856538|NCT00336323|FG002|Participant Flow|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856539|NCT00336323|FG003|Participant Flow|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
10856540|NCT00336323|FG004|Participant Flow|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
10856541|NCT00336323|OG000|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
10856542|NCT00336323|OG001|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856543|NCT00336323|OG002|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856544|NCT00336323|OG003|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
10856545|NCT00336323|OG004|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
10856546|NCT00336323|OG000|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
10856547|NCT00336323|OG000|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
10856548|NCT00336323|OG000|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
11223074|NCT02350881|OG000|Outcome|Absence|Number of feet where no bone resorption was observed
10856549|NCT00336323|OG000|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856550|NCT00336323|EG000|Reported Event|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
10856551|NCT00336323|EG001|Reported Event|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856552|NCT00336323|EG002|Reported Event|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
10856553|NCT00336323|EG003|Reported Event|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
10856554|NCT00336323|EG004|Reported Event|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
10856555|NCT00336479|BG000|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10856556|NCT00336479|BG001|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
11223075|NCT02350881|OG001|Outcome|Presence|Number of feet where bone resorption was observed
11223076|NCT02350881|OG001|Outcome|Moderate|umber of patients reporting a moderate pain
11223077|NCT02350881|OG000|Outcome|Improved|Number of patients who declared an improvement in their walking perimeter
11223078|NCT02350881|OG001|Outcome|Same|Number of patients who declared no improvement in their walking perimeter
11223079|NCT02350881|OG002|Outcome|Worsened|Number of patients who declared a worsening of their walking perimeter
11223080|NCT02350881|OG000|Outcome|Disappeared|Number of patients who declared an absence of pain during walking postoperatively
10856557|NCT00336479|BG002|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
10856558|NCT00336479|BG003|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
10856559|NCT00336479|BG004|Baseline|Total|Total of all reporting groups
10856560|NCT00336479|FG000|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10856561|NCT00336479|FG001|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10856562|NCT00336479|FG002|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
10856563|NCT00336479|FG003|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
10856564|NCT00336479|OG000|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10856565|NCT00336479|OG001|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10856566|NCT00336479|OG002|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
10856567|NCT00336479|OG003|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
10856568|NCT00336479|OG000|Outcome|Telaprevir|"All Subjects from Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, and Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks."
10856569|NCT00336479|EG000|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10856570|NCT00336479|EG001|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10856571|NCT00336479|EG002|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
10856572|NCT00336479|EG003|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
10856573|NCT00336492|BG000|Baseline|Not Randomized Group|Participants who were not randomized at Week 8
10856574|NCT00336492|BG001|Baseline|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
10856575|NCT00336492|BG002|Baseline|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
10856576|NCT00336492|BG003|Baseline|Total|Total of all reporting groups
10856577|NCT00336492|FG000|Participant Flow|Not Randomized Group|Participants who were not randomized at Week 8
11223081|NCT02350881|OG001|Outcome|Less|Number of patients who declared a slight improvement of pain during walking postoperatively
10856578|NCT00336492|FG001|Participant Flow|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
11223082|NCT02350881|OG002|Outcome|Same|Number of patients who declared no improvement in pain during walking postoperatively
10845582|NCT00267748|EG000|Reported Event|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
10856579|NCT00336492|FG002|Participant Flow|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
10856580|NCT00336492|OG000|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg group
10856581|NCT00336492|OG000|Outcome|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
10856582|NCT00336492|OG001|Outcome|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
10856583|NCT00336492|EG000|Reported Event|Not Randomized Group|Participants who were not randomized at Week 8
10856584|NCT00336492|EG001|Reported Event|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
10845583|NCT00267748|EG001|Reported Event|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
10845584|NCT00267748|EG002|Reported Event|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
10845585|NCT00267774|BG000|Baseline|FFR Guided PCI|Fractional flow reserve
10845586|NCT00267774|BG001|Baseline|Angio-guided PCI|Angio-guided PCI
10845587|NCT00267774|BG002|Baseline|Total|Total of all reporting groups
10845588|NCT00267774|FG000|Participant Flow|FFR Guided PCI|Fractional flow reserve
10845589|NCT00267774|FG001|Participant Flow|Angio-guided PCI|Angio-guided PCI
10845590|NCT00267774|OG000|Outcome|FFR Guided PCI|Fractional flow reserve
10845591|NCT00267774|OG001|Outcome|Angio-guided PCI|Angio-guided PCI
10845592|NCT00267774|EG000|Reported Event|FFR Guided PCI|Fractional flow reserve
10845593|NCT00267774|EG001|Reported Event|Angio-guided PCI|Angio-guided PCI
10845594|NCT00267865|BG000|Baseline|Rituximab, High-Dose Methotrexate & Leucovorin Treatment|"Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.~Methotrexate: 6000 mg/m^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.~Rituximab: 375 mg/m^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate~Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes"
10845595|NCT00267865|FG000|Participant Flow|Rituximab, High-Dose Methotrexate & Leucovorin Treatment|"Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.~Methotrexate: 6000 mg/m^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.~Rituximab: 375 mg/m^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate~Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes"
10845596|NCT00267865|OG000|Outcome|Rituximab, High-Dose Methotrexate & Leucovorin Treatment|"Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.~Methotrexate: 6000 mg/m^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.~Rituximab: 375 mg/m^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate~Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes"
10845597|NCT00267865|EG000|Reported Event|Rituximab, High-Dose Methotrexate & Leucovorin Treatment|"Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.~Methotrexate: 6000 mg/m^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.~Rituximab: 375 mg/m^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate~Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes"
10845598|NCT00267956|BG000|Baseline|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
10845599|NCT00267956|BG001|Baseline|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
10845600|NCT00267956|BG002|Baseline|Total|Total of all reporting groups
10845601|NCT00267956|FG000|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10845602|NCT00267956|FG001|Participant Flow|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab x 4 Group
10845603|NCT00267956|FG002|Participant Flow|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
10845604|NCT00267956|FG003|Participant Flow|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
10845605|NCT00267956|OG000|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
10845606|NCT00267956|OG001|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
10845607|NCT00267956|EG000|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10845608|NCT00267956|EG001|Reported Event|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group
10845609|NCT00267956|EG002|Reported Event|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
10856585|NCT00336492|EG002|Reported Event|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
10856586|NCT00336505|BG000|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
10845610|NCT00267956|EG003|Reported Event|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
10845611|NCT00267969|BG000|Baseline|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
10845612|NCT00267969|BG001|Baseline|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
10845613|NCT00267969|BG002|Baseline|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
10845614|NCT00267969|BG003|Baseline|Total|Total of all reporting groups
10845615|NCT00267969|FG000|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
10845616|NCT00267969|FG001|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
10845617|NCT00267969|FG002|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
10845618|NCT00267969|FG003|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
10845619|NCT00267969|FG004|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
10845620|NCT00267969|FG005|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) - patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
10845621|NCT00267969|FG006|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) - patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
10845622|NCT00267969|OG000|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
10845623|NCT00267969|OG001|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
10845624|NCT00267969|OG002|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
10845625|NCT00267969|OG000|Outcome|Group 1: Ustekinumab 45 mg Withdrawal Group|Patients received ustekinumab 45 mg at Weeks 0, 4, 16 and 28.
10845626|NCT00267969|OG001|Outcome|Group 2: Ustekinumab 45 mg Every 12 Weeks|Patients received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
10845627|NCT00267969|OG002|Outcome|Group 3: Ustekinumab 90 mg Withdrawal|Patients received ustekinumab 90 mg at Weeks 0, 4, 16 and 28.
10845628|NCT00267969|OG003|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Patients received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
10845629|NCT00267969|OG004|Outcome|Group 5: Withdrawal Combined Group|Groups 1 and 3 (Withdrawal Combined)
10845630|NCT00267969|OG005|Outcome|Group 6: Combined Ustekinumab Every 12 Weeks|Groups 2 and 4 (Combined Ustekinumab every 12 weeks)
10845631|NCT00267969|EG000|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
10845632|NCT00267969|EG001|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
10845633|NCT00267969|EG002|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
10845634|NCT00267969|EG003|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
10845635|NCT00267969|EG004|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
10845636|NCT00267969|EG005|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) - patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
10845637|NCT00267969|EG006|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) - patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
10846093|NCT00272987|BG001|Baseline|Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
10856587|NCT00336505|BG001|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
10856588|NCT00336505|BG002|Baseline|Total|Total of all reporting groups
10856589|NCT00336505|FG000|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
10856590|NCT00336505|FG001|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
10856591|NCT00336505|OG000|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
10856592|NCT00336505|OG001|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
10856593|NCT00336505|EG000|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
10856594|NCT00336505|EG001|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
10856595|NCT00336544|BG000|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
10856596|NCT00336544|BG001|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
10856597|NCT00336544|BG002|Baseline|Total|Total of all reporting groups
10856598|NCT00336544|FG000|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
10856599|NCT00336544|FG001|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
10856600|NCT00336544|OG000|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
10856601|NCT00336544|OG001|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
10856602|NCT00336544|EG000|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
10856603|NCT00336544|EG001|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
10856604|NCT00336583|BG000|Baseline|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
10856605|NCT00336583|FG000|Participant Flow|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
10856606|NCT00336583|OG000|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
10856607|NCT00336583|EG000|Reported Event|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
10856608|NCT00336700|BG000|Baseline|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
10856609|NCT00336700|FG000|Participant Flow|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
10856610|NCT00336700|OG000|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
10856611|NCT00336700|EG000|Reported Event|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|
10856612|NCT00336817|BG000|Baseline|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
10856613|NCT00336817|BG001|Baseline|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
10856614|NCT00336817|BG002|Baseline|Total|Total of all reporting groups
10856615|NCT00336817|FG000|Participant Flow|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
10856616|NCT00336817|FG001|Participant Flow|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
10856617|NCT00336817|OG000|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
10856618|NCT00336817|OG001|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
10856619|NCT00336817|OG000|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days~Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis"
10856620|NCT00336817|OG001|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days~Results: 2 participants in the CellCept group discontinued drug use"
10856621|NCT00336817|EG000|Reported Event|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
10856622|NCT00336817|EG001|Reported Event|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
10856623|NCT00336856|BG000|Baseline|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC who received Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV), followed by 500 mg/m2 every 2 weeks IV
10856624|NCT00336856|FG000|Participant Flow|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC
11223083|NCT02350881|OG003|Outcome|Greater|Number of patients who declared a worsening of pain during walking postoperatively
10856625|NCT00336856|OG000|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
10856626|NCT00336856|EG000|Reported Event|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
10856627|NCT00336895|BG000|Baseline|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
10856628|NCT00336895|FG000|Participant Flow|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
10856629|NCT00336895|OG000|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
10856630|NCT00336895|EG000|Reported Event|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
10856631|NCT00337077|BG000|Baseline|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856632|NCT00337077|BG001|Baseline|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856633|NCT00337077|BG002|Baseline|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856634|NCT00337077|BG003|Baseline|Total|Total of all reporting groups
10856635|NCT00337077|FG000|Participant Flow|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856636|NCT00337077|FG001|Participant Flow|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856637|NCT00337077|FG002|Participant Flow|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856638|NCT00337077|OG000|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856639|NCT00337077|OG001|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856640|NCT00337077|OG002|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10856641|NCT00337077|EG000|Reported Event|Eribulin Mesylate|All treated patients are evaluated for toxicities except for one patient who died soon after starting treatment and was not assessed for toxicity.
10856642|NCT00337103|BG000|Baseline|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
10856643|NCT00337103|BG001|Baseline|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
10856644|NCT00337103|BG002|Baseline|Total|Total of all reporting groups
10856645|NCT00337103|FG000|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 milligram per meter square (mg/m^2) intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
10856646|NCT00337103|FG001|Participant Flow|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 gram per meter square per day (g/m^2/day) administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
10856647|NCT00337103|OG000|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
10856648|NCT00337103|OG001|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
10856649|NCT00337103|OG001|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
10856650|NCT00337103|EG000|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
10856651|NCT00337103|EG001|Reported Event|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
10856652|NCT00337129|BG000|Baseline|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
10856653|NCT00337129|FG000|Participant Flow|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
10856654|NCT00337129|OG000|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
10856655|NCT00337129|EG000|Reported Event|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
10856656|NCT00337168|BG000|Baseline|Induction|
10856657|NCT00337168|FG000|Participant Flow|Induction|Clofarabine (40 mg per meters squared per day) and cytarabine (1 g per meters squared per day)
10856658|NCT00337168|OG000|Outcome|Induction|
10856659|NCT00337168|OG000|Outcome|Induction|Up to two induction cycles with clofarabine and cytarabine
10856660|NCT00337168|EG000|Reported Event|Induction|Up to two induction cycles with clofarabine and cytarabine
10856661|NCT00337181|BG000|Baseline|Vaccine Group|Received vaccination in RV144
10856662|NCT00337181|BG001|Baseline|Placebo Group|Received placebo in RV144
10856663|NCT00337181|BG002|Baseline|Total|Total of all reporting groups
10856664|NCT00337181|FG000|Participant Flow|Vaccine Group|Received vaccination in RV144
10856665|NCT00337181|FG001|Participant Flow|Placebo Group|Received placebo in RV144
10856666|NCT00337181|OG000|Outcome|Vaccine Group|Received vaccination in RV144
10856667|NCT00337181|OG001|Outcome|Placebo Group|Received placebo in RV144
10856668|NCT00337181|EG000|Reported Event|Vaccine Group|Received vaccination in RV144
10856669|NCT00337181|EG001|Reported Event|Placebo Group|Received placebo in RV144
10856670|NCT00337194|BG000|Baseline|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11126312|NCT00145158|EG001|Reported Event|Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51|Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
10856671|NCT00337194|BG001|Baseline|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10856672|NCT00337194|BG002|Baseline|Total|Total of all reporting groups
10856673|NCT00337194|FG000|Participant Flow|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10856674|NCT00337194|FG001|Participant Flow|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10856675|NCT00337194|OG000|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10856676|NCT00337194|OG001|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10856677|NCT00337194|OG000|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
10856678|NCT00337194|OG001|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
10878905|NCT00454649|OG006|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
11223084|NCT02350881|OG000|Outcome|Disappeared|Number of patients who declared an absence of pain at rest postoperatively
11126313|NCT01732809|BG000|Baseline|Group A|Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the right side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the left side.
11223085|NCT02350881|OG001|Outcome|Less|Number of patients who declared a slight improvement of pain at rest postoperatively
10856679|NCT00337194|EG000|Reported Event|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10856680|NCT00337194|EG001|Reported Event|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharma"
10878906|NCT00454649|OG007|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
10878907|NCT00454649|OG008|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
10878908|NCT00454649|OG000|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) oral tablet of 1 mg (milligram) administered twice daily (BID) as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
10878909|NCT00454649|OG001|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|AG-013736 3 oral tablets of 1 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
10878910|NCT00454649|OG002|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
10878911|NCT00454649|OG003|Outcome|Axitinib + Paclitaxel (Cohort 4)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 25 of Cycle 1 (cycle length 28 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel 90 mg/m^2 administered as 60-minute infusion on Day 1, 8, and 15 of every cycle.
10878912|NCT00454649|OG004|Outcome|Axitinib + Docetaxel (Cohort 5)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1. AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Docetaxel 100 mg/m^2 administered as 60-minute infusion on Day 1 of every cycle.
10878913|NCT00454649|OG005|Outcome|Axitinib + Capecitabine (Cohort 6)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1000 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
10878914|NCT00454649|OG006|Outcome|Axitinib + Capecitabine (Cohort 7)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1250 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
10878915|NCT00454649|OG007|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval. Cisplatin 80 mg/m^2 administered as infusion on Day 1 of Cycle 1 and all subsequent cycles. Gemcitabine 1250 mg/m^2 administered as infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles.
10878916|NCT00454649|OG008|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 administered as infusion on Day 1 Cycle 1 and all subsequent cycles.
11223086|NCT02350881|OG002|Outcome|Same|Number of patients who declared no improvement in pain at rest postoperatively
11223087|NCT02350881|OG003|Outcome|Greater|Number of patients who declared a worsening of pain at rest postoperatively
11223088|NCT02350881|OG000|Outcome|Survival|Percentage of feet with implant still in place
11223089|NCT02350881|OG001|Outcome|Revisions|Percentage of feet reoperated for implant ablation
11223090|NCT02350881|EG000|Reported Event|Overall Cohort|one consecutive series of patients were included
10856681|NCT00337207|BG000|Baseline|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
10856682|NCT00337207|FG000|Participant Flow|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
10856683|NCT00337207|OG000|Outcome|Bevacizumab Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
10856684|NCT00337207|OG000|Outcome|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
10856685|NCT00337207|EG000|Reported Event|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
10856686|NCT00337272|BG000|Baseline|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
10856687|NCT00337272|BG001|Baseline|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
10856688|NCT00337272|BG002|Baseline|Total|Total of all reporting groups
10856689|NCT00337272|FG000|Participant Flow|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
10856690|NCT00337272|FG001|Participant Flow|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
10856691|NCT00337272|OG000|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
10856692|NCT00337272|OG001|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
10856693|NCT00337272|EG000|Reported Event|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
10856694|NCT00337272|EG001|Reported Event|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
10856695|NCT00337285|BG000|Baseline|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
10856696|NCT00337285|FG000|Participant Flow|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
10856697|NCT00337285|OG000|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
10856698|NCT00337285|EG000|Reported Event|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
10856699|NCT00337350|BG000|Baseline|Rosiglitazone|rosiglitazone 4mg/day
10856700|NCT00337350|BG001|Baseline|Placebo|matched placebo for rosiglitazone 4mg/day
10856701|NCT00337350|BG002|Baseline|Total|Total of all reporting groups
10856702|NCT00337350|FG000|Participant Flow|Rosiglitazone|rosiglitazone 4mg/day
10856703|NCT00337350|FG001|Participant Flow|Placebo|matched placebo for rosiglitazone 4mg/day
10856704|NCT00337350|OG000|Outcome|Rosiglitazone|rosiglitazone 4mg/day
10856705|NCT00337350|OG001|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
10856706|NCT00337350|EG000|Reported Event|Rosiglitazone|rosiglitazone 4mg/day
10856707|NCT00337350|EG001|Reported Event|Placebo|matched placebo for rosiglitazone 4mg/day
10856708|NCT00337428|BG000|Baseline|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
10856709|NCT00337428|BG001|Baseline|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
10856710|NCT00337428|BG002|Baseline|Total|Total of all reporting groups
10856711|NCT00337428|FG000|Participant Flow|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
10856712|NCT00337428|FG001|Participant Flow|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
10856713|NCT00337428|OG000|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
10856714|NCT00337428|OG001|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
10856715|NCT00337428|EG000|Reported Event|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
10856716|NCT00337428|EG001|Reported Event|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
10856717|NCT00337467|BG000|Baseline|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
10856718|NCT00337467|FG000|Participant Flow|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
10856719|NCT00337467|OG000|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
10856720|NCT00337467|OG000|Outcome|Proportion of Participants|Proportion of participants without treatment failure at the end of interval
10856721|NCT00337467|OG000|Outcome|Proportion of Participants|Proportion of participants without virologic rebound at the end of interval
10856722|NCT00337467|OG000|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
10856723|NCT00337467|EG000|Reported Event|ATV/RTV Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
10845654|NCT00268346|EG001|Reported Event|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
10856724|NCT00337571|BG000|Baseline|Placebo|
10856725|NCT00337571|BG001|Baseline|Aripiprazole 5 mg|
10856726|NCT00337571|BG002|Baseline|Aripiprazole 10 mg|
10856727|NCT00337571|BG003|Baseline|Aripiprazole 15 mg|
10856728|NCT00337571|BG004|Baseline|Total|Total of all reporting groups
10856729|NCT00337571|FG000|Participant Flow|Placebo|
10856730|NCT00337571|FG001|Participant Flow|Aripiprazole 5 mg|
10856731|NCT00337571|FG002|Participant Flow|Aripiprazole 10 mg|
10856732|NCT00337571|FG003|Participant Flow|Aripiprazole 15 mg|
10856733|NCT00337571|OG000|Outcome|Placebo|
10856734|NCT00337571|OG001|Outcome|Aripiprazole 5 mg|
10856735|NCT00337571|OG002|Outcome|Aripiprazole 10 mg|
10856736|NCT00337571|OG003|Outcome|Aripiprazole 15 mg|
10856737|NCT00337571|EG000|Reported Event|Aripiprazole 10 mg|
10856738|NCT00337571|EG001|Reported Event|Aripiprazole 15 mg|
10856739|NCT00337571|EG002|Reported Event|Aripiprazole 5 mg|
10856740|NCT00337571|EG003|Reported Event|Placebo|
10856741|NCT00337610|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
10856742|NCT00337610|BG001|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
10856743|NCT00337610|BG002|Baseline|Total|Total of all reporting groups
10856744|NCT00337610|FG000|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
10856745|NCT00337610|FG001|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
10856746|NCT00337610|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
10856747|NCT00337610|OG001|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
10856748|NCT00337610|EG000|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
10856749|NCT00337610|EG001|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
10856750|NCT00337662|BG000|Baseline|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
10856751|NCT00337662|BG001|Baseline|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
10856752|NCT00337662|BG002|Baseline|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
10856753|NCT00337662|BG003|Baseline|Total|Total of all reporting groups
10856754|NCT00337662|FG000|Participant Flow|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
10856755|NCT00337662|FG001|Participant Flow|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
10856756|NCT00337662|FG002|Participant Flow|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
10856757|NCT00337662|FG003|Participant Flow|Risperiodone Open-Label Lead-In|"All patients completed a 2-week open-label risperidone lead-in period. This group contains all patients who started Study Period II.~Risperidone: 2-6 mg, oral, daily"
10856758|NCT00337662|OG000|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
10856759|NCT00337662|OG001|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
10856760|NCT00337662|OG001|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
10856761|NCT00337662|OG000|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
10856762|NCT00337662|OG001|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
10856763|NCT00337662|OG002|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
10856764|NCT00337662|EG000|Reported Event|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks.
10856765|NCT00337662|EG001|Reported Event|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
10856766|NCT00337662|EG002|Reported Event|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
10856767|NCT00337727|BG000|Baseline|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
10856768|NCT00337727|BG001|Baseline|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
10856769|NCT00337727|BG002|Baseline|Total|Total of all reporting groups
10856770|NCT00337727|FG000|Participant Flow|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
10856771|NCT00337727|FG001|Participant Flow|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
10856772|NCT00337727|OG000|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
10856773|NCT00337727|OG001|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
10856774|NCT00337727|EG000|Reported Event|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
10856775|NCT00337727|EG001|Reported Event|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
10856776|NCT00337779|BG000|Baseline|Glatiramer Acetate 20 mg|
10856777|NCT00337779|BG001|Baseline|Glatiramer Acetate 40 mg|
10856778|NCT00337779|BG002|Baseline|Total|Total of all reporting groups
10856779|NCT00337779|FG000|Participant Flow|Glatiramer Acetate 20 mg|
10856780|NCT00337779|FG001|Participant Flow|Glatiramer Acetate 40 mg|
10856781|NCT00337779|OG000|Outcome|Glatiramer Acetate 20 mg|
10856782|NCT00337779|OG001|Outcome|Glatiramer Acetate 40 mg|
10856783|NCT00337779|EG000|Reported Event|Glatiramer Acetate 20 mg|
10856784|NCT00337779|EG001|Reported Event|Glatiramer Acetate 40 mg|
10856785|NCT00337818|BG000|Baseline|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
10856786|NCT00337818|BG001|Baseline|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
10856787|NCT00337818|BG002|Baseline|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
10856788|NCT00337818|BG003|Baseline|Total|Total of all reporting groups
10856789|NCT00337818|FG000|Participant Flow|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
10856790|NCT00337818|FG001|Participant Flow|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
10856791|NCT00337818|FG002|Participant Flow|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
10856792|NCT00337818|OG000|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
10856793|NCT00337818|OG001|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
10856794|NCT00337818|OG002|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
10856795|NCT00337818|EG000|Reported Event|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
10856796|NCT00337818|EG001|Reported Event|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
10856797|NCT00337818|EG002|Reported Event|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
10856798|NCT00337935|BG000|Baseline|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
10856799|NCT00337935|BG001|Baseline|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
10856800|NCT00337935|BG002|Baseline|Total|Total of all reporting groups
10856801|NCT00337935|FG000|Participant Flow|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
10856802|NCT00337935|FG001|Participant Flow|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
10856803|NCT00337935|OG000|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
10856804|NCT00337935|OG001|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
10856805|NCT00337935|OG000|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs). Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.
10856806|NCT00337935|EG000|Reported Event|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
10856807|NCT00337935|EG001|Reported Event|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
10856808|NCT00337987|BG000|Baseline|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
10856809|NCT00337987|FG000|Participant Flow|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
10856810|NCT00337987|OG000|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
10856811|NCT00337987|EG000|Reported Event|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
10856812|NCT00338039|BG000|Baseline|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
11126314|NCT01732809|BG001|Baseline|Group B|Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the left side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the right side.
10856813|NCT00338039|FG000|Participant Flow|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Grey delivered in 28 fractions.
10856814|NCT00338039|OG000|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
10856815|NCT00338039|EG000|Reported Event|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
10856816|NCT00338286|BG000|Baseline|Standard Supportive Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion
10856817|NCT00338286|BG001|Baseline|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
10856818|NCT00338286|BG002|Baseline|Total|Total of all reporting groups
10856819|NCT00338286|FG000|Participant Flow|Standard Supportive Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion
10856820|NCT00338286|FG001|Participant Flow|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
10856821|NCT00338286|OG000|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
10856822|NCT00338286|OG001|Outcome|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
10856823|NCT00338286|EG000|Reported Event|Standard Supportive Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion
10856824|NCT00338286|EG001|Reported Event|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
10856825|NCT00338598|BG000|Baseline|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
10856826|NCT00338598|BG001|Baseline|Placebo|"placebo will be administered.~placebo"
10856827|NCT00338598|BG002|Baseline|Total|Total of all reporting groups
10856828|NCT00338598|FG000|Participant Flow|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
10856829|NCT00338598|FG001|Participant Flow|Placebo|"placebo will be administered.~placebo"
10856830|NCT00338598|OG000|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
10856831|NCT00338598|OG001|Outcome|Placebo|"placebo will be administered.~placebo"
10856832|NCT00338598|EG000|Reported Event|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
10856833|NCT00338598|EG001|Reported Event|Placebo|"placebo will be administered.~placebo"
10856834|NCT00338728|BG000|Baseline|Letrozole and Imatinib Mesylate|Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
10856835|NCT00338728|FG000|Participant Flow|Letrozole and Imatinib Mesylate|Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
10856836|NCT00338728|OG000|Outcome|Letrozole and Imatinib Mesylate|Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
10856837|NCT00338728|EG000|Reported Event|Letrozole and Imatinib Mesylate|Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
10856838|NCT00338741|BG000|Baseline|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
10856839|NCT00338741|BG001|Baseline|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
10856840|NCT00338741|BG002|Baseline|Total|Total of all reporting groups
10856841|NCT00338741|FG000|Participant Flow|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
10856842|NCT00338741|FG001|Participant Flow|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
10856843|NCT00338741|OG000|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
10856844|NCT00338741|OG001|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
10856845|NCT00338741|EG000|Reported Event|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
10856846|NCT00338741|EG001|Reported Event|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
10848858|NCT00292162|FG000|Participant Flow|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
11126315|NCT01732809|BG002|Baseline|Total|Total of all reporting groups
11223091|NCT02350998|BG000|Baseline|6 mg OTO-201|6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
10856847|NCT00338806|BG000|Baseline|IPT- Prevention for Adolescents|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
10856848|NCT00338806|BG001|Baseline|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
10856849|NCT00338806|BG002|Baseline|Total|Total of all reporting groups
10856850|NCT00338806|FG000|Participant Flow|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
10856851|NCT00338806|FG001|Participant Flow|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
10856852|NCT00338806|OG000|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
10856853|NCT00338806|OG001|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
10856854|NCT00338806|OG000|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
10856855|NCT00338806|OG001|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
10856856|NCT00338806|EG000|Reported Event|Interpersonal Psychotherapy for Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
10856857|NCT00338806|EG001|Reported Event|Educational Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
10856858|NCT00338884|BG000|Baseline|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
10856859|NCT00338884|FG000|Participant Flow|Sunitinib|37.5 milligrams (mg) oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
10856860|NCT00338884|OG000|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
10856861|NCT00338884|EG000|Reported Event|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
10856862|NCT00338949|BG000|Baseline|Control|Remain on risperidone or olanzapine.
10856863|NCT00338949|BG001|Baseline|Switch|Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
10856864|NCT00338949|BG002|Baseline|Total|Total of all reporting groups
10856865|NCT00338949|FG000|Participant Flow|Control|Remain on risperidone or olanzapine.
10856866|NCT00338949|FG001|Participant Flow|Switch|Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
10856867|NCT00338949|OG000|Outcome|Control|Remain on risperidone or olanzapine.
10856868|NCT00338949|OG001|Outcome|Switch|Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
10856869|NCT00338949|EG000|Reported Event|Control|Remain on risperidone or olanzapine.
10856870|NCT00338949|EG001|Reported Event|Switch|Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
10856871|NCT00338962|BG000|Baseline|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
10856872|NCT00338962|BG001|Baseline|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
10856873|NCT00338962|BG002|Baseline|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
10856874|NCT00338962|BG003|Baseline|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
10856875|NCT00338962|BG004|Baseline|Total|Total of all reporting groups
10856876|NCT00338962|FG000|Participant Flow|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
10856877|NCT00338962|FG001|Participant Flow|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
11126316|NCT01732809|FG000|Participant Flow|Group A|Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the right side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the left side.
10856878|NCT00338962|FG002|Participant Flow|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
10856879|NCT00338962|FG003|Participant Flow|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
10856880|NCT00338962|OG000|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
10856881|NCT00338962|OG001|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
10856882|NCT00338962|OG002|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
10856883|NCT00338962|OG003|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
10856884|NCT00338962|EG000|Reported Event|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
10856885|NCT00338962|EG001|Reported Event|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
10856886|NCT00338962|EG002|Reported Event|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
10856887|NCT00338962|EG003|Reported Event|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
10856888|NCT00338988|BG000|Baseline|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
10856889|NCT00338988|FG000|Participant Flow|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
10856890|NCT00338988|OG000|Outcome|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
10856891|NCT00338988|EG000|Reported Event|Stratum: 1 Prior Regimen|Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
10856892|NCT00338988|EG001|Reported Event|Stratum 2: No Prior Therapy|Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
10856893|NCT00339040|BG000|Baseline|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
10856894|NCT00339040|BG001|Baseline|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
10856895|NCT00339040|BG002|Baseline|Total|Total of all reporting groups
10856896|NCT00339040|FG000|Participant Flow|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
10856897|NCT00339040|FG001|Participant Flow|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
10856898|NCT00339040|OG000|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
10856899|NCT00339040|OG001|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
10856900|NCT00339040|EG000|Reported Event|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
10856901|NCT00339040|EG001|Reported Event|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
10856902|NCT00339079|BG000|Baseline|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
10856903|NCT00339079|BG001|Baseline|Placebo|Patients only received placebo pills
10856904|NCT00339079|BG002|Baseline|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter.
10856905|NCT00339079|BG003|Baseline|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when administered alone in the other arms.
10856906|NCT00339079|BG004|Baseline|Total|Total of all reporting groups
10856907|NCT00339079|FG000|Participant Flow|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
11223092|NCT02350998|FG000|Participant Flow|6 mg OTO-201|6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
10856908|NCT00339079|FG001|Participant Flow|Placebo|Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office
10856909|NCT00339079|FG002|Participant Flow|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
10856910|NCT00339079|FG003|Participant Flow|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
10856911|NCT00339079|OG000|Outcome|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
10856912|NCT00339079|OG001|Outcome|Placebo|Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office
10856913|NCT00339079|OG002|Outcome|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
10856914|NCT00339079|OG003|Outcome|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
10856915|NCT00339079|OG000|Outcome|Cognitive Behavioral Therapy (CBT)|"Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length."
10856916|NCT00339079|OG001|Outcome|Placebo|"Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Supportive Therapy: The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.~Placebo: Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter."
10856917|NCT00339079|OG002|Outcome|Fluoxetine|"Patients received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Fluoxetine: Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.~Supportiv"
10856918|NCT00339079|OG003|Outcome|Combined CBT and Fluoxetine|"Patients arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.~Fluoxetine: Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes wi"
10856919|NCT00339079|EG000|Reported Event|Cognitive Behavioral Therapy (CBT)|"Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length."
10856920|NCT00339079|EG001|Reported Event|Placebo|"Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Supportive Therapy: The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.~Placebo: Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter."
10856921|NCT00339079|EG002|Reported Event|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
10856922|NCT00339079|EG003|Reported Event|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
10856923|NCT00339144|BG000|Baseline|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
10856924|NCT00339144|BG001|Baseline|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
10856925|NCT00339144|BG002|Baseline|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
10856926|NCT00339144|BG003|Baseline|Total|Total of all reporting groups
10856927|NCT00339144|FG000|Participant Flow|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
10856928|NCT00339144|FG001|Participant Flow|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
10856929|NCT00339144|FG002|Participant Flow|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
10856930|NCT00339144|OG000|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
10856931|NCT00339144|OG001|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
10856932|NCT00339144|OG002|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
10856933|NCT00339144|OG000|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
10856934|NCT00339144|EG000|Reported Event|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
10856935|NCT00339144|EG001|Reported Event|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
10856936|NCT00339144|EG002|Reported Event|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
10856937|NCT00339183|BG000|Baseline|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
11223093|NCT02350998|OG000|Outcome|6mg OTO-201|6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
10856938|NCT00339183|BG001|Baseline|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
10856939|NCT00339183|BG002|Baseline|Total|Total of all reporting groups
10856940|NCT00339183|FG000|Participant Flow|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
10856941|NCT00339183|FG001|Participant Flow|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
10856942|NCT00339183|OG000|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
10856943|NCT00339183|OG001|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
10856944|NCT00339183|OG002|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
10856945|NCT00339183|OG003|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
10856946|NCT00339183|OG000|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
10856947|NCT00339183|OG001|Outcome|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
10856948|NCT00339183|EG000|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
10856949|NCT00339183|EG001|Reported Event|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
10856950|NCT00339833|BG000|Baseline|Salsalate|Salsalate (3g/day) for 7 days
10856951|NCT00339833|BG001|Baseline|Placebo|Identical placebo for 7 days
10856952|NCT00339833|BG002|Baseline|Total|Total of all reporting groups
10856953|NCT00339833|FG000|Participant Flow|Salsalate|The intervention was salsalate (3g/day) for 7 days
10856954|NCT00339833|FG001|Participant Flow|Placebo|Placebo for 7 days.
10856955|NCT00339833|OG000|Outcome|Salsalate|Salsalate (3g/day) for 7 days
10856956|NCT00339833|OG001|Outcome|Placebo|Identical placebo for 7 days
10856957|NCT00339833|EG000|Reported Event|Salsalate|Salsalate (3g/day) for 7 days
10856958|NCT00339833|EG001|Reported Event|Placebo|Identical placebo for 7 days
10856959|NCT00340379|BG000|Baseline|Ziprasidone|
10856960|NCT00340379|BG001|Baseline|Sertraline/Haloperidol|
10856961|NCT00340379|BG002|Baseline|Total|Total of all reporting groups
10856962|NCT00340379|FG000|Participant Flow|Ziprasidone|Target dosage of 120-160mg/day based on tolerance.
10856963|NCT00340379|FG001|Participant Flow|Sertraline/Haloperidol|Target dosage of 150-200mg/day for sertraline and 6-8mg/day for haloperidol.
10856964|NCT00340379|OG000|Outcome|Ziprasidone|
10856965|NCT00340379|OG001|Outcome|Sertraline/Haloperidol|
10856966|NCT00340379|EG000|Reported Event|Ziprasidone|
10856967|NCT00340379|EG001|Reported Event|Sertraline/Haloperidol|
10856968|NCT00340678|BG000|Baseline|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
10856969|NCT00340678|BG001|Baseline|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
10856970|NCT00340678|BG002|Baseline|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
10856971|NCT00340678|BG003|Baseline|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
11223094|NCT02350998|OG000|Outcome|6 mg OTO-201|6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
11223095|NCT02350998|OG000|Outcome|6 mg OTO-201|6 mg ciprofloxacin: single Trans-Tympanic Tube Admin istration
11223096|NCT02350998|EG000|Reported Event|6 mg OTO-201|6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
11223097|NCT02351037|BG000|Baseline|Ibrutinib Monotherapy Cohort|"Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.~Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis."
10856972|NCT00340678|BG004|Baseline|Total|Total of all reporting groups
10856973|NCT00340678|FG000|Participant Flow|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
10856974|NCT00340678|FG001|Participant Flow|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
10856975|NCT00340678|FG002|Participant Flow|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
10856976|NCT00340678|FG003|Participant Flow|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
10856977|NCT00340678|OG000|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
10856978|NCT00340678|OG001|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
10856979|NCT00340678|OG002|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
10856980|NCT00340678|OG003|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
10856981|NCT00340678|EG000|Reported Event|Losartan|Subjects received losartan
10856982|NCT00340678|EG001|Reported Event|Placebo|Subjects received placebo
10856983|NCT00340704|BG000|Baseline|Tamsulosin - Low Dose Level (PK Study)|Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10856984|NCT00340704|BG001|Baseline|Tamsulosin - Medium Dose Level (PK Study)|Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
10856985|NCT00340704|BG002|Baseline|Tamsulosin - High Dose Level (PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10856986|NCT00340704|BG003|Baseline|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10856987|NCT00340704|BG004|Baseline|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
10878917|NCT00454649|OG000|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
11126317|NCT01732809|FG001|Participant Flow|Group B|Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the left side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the right side.
10878918|NCT00454649|OG001|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
11126318|NCT01732809|OG000|Outcome|Abobotulinumtoxin A|Patients were randomized to the side of the forehead (left or right) in which the products were administered.
10856988|NCT00340704|BG005|Baseline|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
10856989|NCT00340704|BG006|Baseline|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
10856990|NCT00340704|BG007|Baseline|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10856991|NCT00340704|BG008|Baseline|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10856992|NCT00340704|BG009|Baseline|Total|Total of all reporting groups
10856993|NCT00340704|FG000|Participant Flow|Tamsulosin - Low Dose Level (PK Study)|"Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10856994|NCT00340704|FG001|Participant Flow|Tamsulosin - Medium Dose Level (PK Study)|"Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10856995|NCT00340704|FG002|Participant Flow|Tamsulosin - High Dose Level (PK Study)|"Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.~In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10856996|NCT00340704|FG003|Participant Flow|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
11126319|NCT01732809|OG001|Outcome|Onabotulinumtoxin A|Patients were randomized to the side of the forehead (left or right) in which the products were administered.
11126320|NCT01732809|EG000|Reported Event|Abobotulinumtoxin A|Patients were randomized to the side of the forehead (left or right) in which the products were administered.
10856997|NCT00340704|FG004|Participant Flow|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10856998|NCT00340704|FG005|Participant Flow|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10856999|NCT00340704|FG006|Participant Flow|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10857000|NCT00340704|FG007|Participant Flow|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10857001|NCT00340704|FG008|Participant Flow|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10857002|NCT00340704|OG000|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10857003|NCT00340704|OG001|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10878919|NCT00454649|OG000|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
11126321|NCT01732809|EG001|Reported Event|Onabotulinumtoxin A|Patients were randomized to the side of the forehead (left or right) in which the products were administered.
11126322|NCT01732822|BG000|Baseline|Ticagrelor 90mg bd|
10857004|NCT00340704|OG002|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10857005|NCT00340704|OG003|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10857006|NCT00340704|OG004|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10857007|NCT00340704|OG005|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10857008|NCT00340704|OG000|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10857009|NCT00340704|OG001|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10857010|NCT00340704|OG002|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10878920|NCT00454649|OG000|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
11126323|NCT01732822|BG001|Baseline|Clopidogrel 75mg od|
11126324|NCT01732822|BG002|Baseline|Total|Total of all reporting groups
11126325|NCT01732822|FG000|Participant Flow|Ticagrelor 90 mg bd|
11126326|NCT01732822|FG001|Participant Flow|Clopidogrel 75 mg od|
11126327|NCT01732822|OG000|Outcome|Ticagrelor 90 mg bd|
11347705|NCT04275336|BG001|Baseline|Distraction Group|"Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain.~Distraction techniques: A trained play therapist will entertain and distract the child with distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and ending when the child left the room after the procedure. Children can choose one or more distraction toys."
11126328|NCT01732822|OG001|Outcome|Clopidogrel 75 mg od|
11126329|NCT01732822|OG000|Outcome|Ticagrelor - Stage I|Baseline Fontaine stage I
11347706|NCT04275336|BG002|Baseline|Combined Group|"Use EMLA cream combined with distraction toys in the management of peripheral venipuncture pain.~EMLA combined with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than play therapist will distract children with the toys(distraction techniques) ,children choose before 5 minutes and throughout the venipuncture procedure."
11347707|NCT04275336|BG003|Baseline|Total|Total of all reporting groups
11347708|NCT04275336|FG000|Participant Flow|EMLA Group|"Use EMLA cream in the management of peripheral venipuncture pain.~EMLA cream will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter."
11347709|NCT04275336|FG001|Participant Flow|Distraction Group|"Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain.~Distraction techniques: A trained play therapist will entertain and distract the child with psychological interventions (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and ending when the child left the room after the procedure. Children can choose one or more."
11347710|NCT04275336|FG002|Participant Flow|Combined Group|"Use EMLA cream combined with psychological interventions in the management of peripheral venipuncture pain.~EMLA combined with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than play therapist will distract children with the toys(distraction techniques) children choose before 5 minutes and throughout the venipuncture procedure."
11347711|NCT04275336|OG000|Outcome|EMLA Group|"Use EMLA cream in the management of peripheral venipuncture pain.~A eutectic mixture of local anesthetics (EMLA) cream containing 25mg lidocaine and 25mg propiocaine per gram will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter."
11347712|NCT04275336|OG001|Outcome|Distraction Group|"Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain.~distraction techniques: A trained play therapist will distract the child with distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and throughout the whole venipuncture procedure. Children can choose one or more distractions techniques."
11347713|NCT04275336|OG002|Outcome|Combined Group|"Use EMLA cream combined with distraction techniques in the management of peripheral venipuncture pain.~EMLA with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than the play therapist will distract children using distraction techniques 5 minutes before and throughout the venipuncture. procedure."
11347714|NCT04275336|OG000|Outcome|EMLA Group|"Use EMLA cream in the management of peripheral venipuncture pain.~EMLA cream will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter."
11347715|NCT04275336|OG001|Outcome|Distraction Group|"Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain.~Distraction techniques: A trained play therapist will entertain and distract the child with psychological interventions (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and ending when the child left the room after the procedure. Children can choose one or more."
11347716|NCT04275336|OG002|Outcome|Combined Group|"Use EMLA cream combined with psychological interventions in the management of peripheral venipuncture pain.~EMLA combined with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than play therapist will distract children with the toys(distraction techniques) children choose before 5 minutes and throughout the venipuncture procedure."
11347717|NCT04275336|EG000|Reported Event|EMLA Group|"Use EMLA cream in the management of peripheral venipuncture pain.~EMLA cream will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter."
11347718|NCT04275336|EG001|Reported Event|Distraction Group|"Use distraction techniques (books, toy whistle, cartoon animation, breathing exercises, electronic products）in the management of peripheral venipuncture pain.~Distraction techniques: A trained play therapist will entertain and distract the child with psychological interventions (books, toy whistle, cartoon animation, breathing exercises, electronic products）starting 5 minutes before the procedure and ending when the child left the room after the procedure. Children can choose one or more."
11347719|NCT04275336|EG002|Reported Event|Combined Group|"Use EMLA cream combined with distraction in the management of peripheral venipuncture pain.~EMLA combined with distraction techniques: EMLA cream will be applied on the venipuncture site for 30 minutes than play therapist will distract children with the toys(distraction techniques) children choose before 5 minutes and throughout the venipuncture procedure."
11347720|NCT04272775|BG000|Baseline|Cohort 1: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
11347721|NCT04272775|BG001|Baseline|Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone|Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
11347722|NCT04272775|BG002|Baseline|Total|Total of all reporting groups
11347723|NCT04272775|FG000|Participant Flow|Cohort 1: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
10857011|NCT00340704|OG000|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10857012|NCT00340704|OG001|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10857013|NCT00340704|OG000|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 - 25.0 kg, 25.1 - 50.0 kg and 50.1 - 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
10857014|NCT00340704|OG000|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
10857015|NCT00340704|OG001|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
10857016|NCT00340704|OG002|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
10857017|NCT00340704|EG000|Reported Event|Tamsulosin - Low Dose Level (Steady State - PK Study)|Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10857018|NCT00340704|EG001|Reported Event|Tamsulosin - Medium Dose Level (Steady State - PK Study)|Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
11126330|NCT01732822|OG001|Outcome|Ticagrelor - Stage IIa|Baseline Fontaine stage IIa
11126331|NCT01732822|OG002|Outcome|Ticagrelor - Stage IIb|Baseline Fontaine stage IIb
10857019|NCT00340704|EG002|Reported Event|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10857020|NCT00340704|EG003|Reported Event|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10857021|NCT00340704|EG004|Reported Event|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
10857022|NCT00340704|EG005|Reported Event|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
10857023|NCT00340704|EG006|Reported Event|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
10857024|NCT00340704|EG007|Reported Event|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10857025|NCT00340704|EG008|Reported Event|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
10857026|NCT00340834|BG000|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
10857027|NCT00340834|BG001|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
10857028|NCT00340834|BG002|Baseline|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
10857029|NCT00340834|BG003|Baseline|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
10976851|NCT00942357|EG000|Reported Event|Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)|"Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Cisplatin: Given IV~Internal Radiation Therapy: Undergo brachytherapy~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy"
11126332|NCT01732822|OG003|Outcome|Ticagrelor - Stage III|Baseline Fontaine stage III
10857030|NCT00340834|BG004|Baseline|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
10857031|NCT00340834|BG005|Baseline|Total|Total of all reporting groups
11126333|NCT01732822|OG004|Outcome|Ticagrelor - Stage IV|Baseline Fontaine stage IV
11126334|NCT01732822|OG005|Outcome|Clopidogrel - Stage I|Baseline Fontaine stage I
10857032|NCT00340834|FG000|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
10857033|NCT00340834|FG001|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
11126335|NCT01732822|OG006|Outcome|Clopidogrel - Stage IIa|Baseline Fontaine stage IIa
11347724|NCT04272775|FG001|Participant Flow|Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone|Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
11347725|NCT04272775|OG000|Outcome|Cohort 1: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
11347726|NCT04272775|OG001|Outcome|Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone|Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
11347727|NCT04272775|EG000|Reported Event|Cohort 1: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
11347728|NCT04272775|EG001|Reported Event|Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone|Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
11347729|NCT04271020|BG000|Baseline|UroLift|"UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).~During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
11347730|NCT04271020|FG000|Participant Flow|UroLift|"UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).~During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
11347731|NCT04271020|OG000|Outcome|UroLift|"UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).~During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
11347732|NCT04271020|EG000|Reported Event|UroLift|"UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).~During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
11347733|NCT04274075|BG000|Baseline|GDC-9545 Treatment Sequence A, B, and C|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence A, B, and C (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347734|NCT04274075|BG001|Baseline|GDC-9545 Treatment Sequence B, C, and A|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence B, C, and A (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347735|NCT04274075|BG002|Baseline|GDC-9545 Treatment Sequence C, A, and B|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence C, A, and B (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347736|NCT04274075|BG003|Baseline|GDC-9545 Treatment Sequence A, C, and B|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence A, C, and B (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347737|NCT04274075|BG004|Baseline|GDC-9545 Treatment Sequence B, A, and C|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence B, A, and C (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347738|NCT04274075|BG005|Baseline|GDC-9545 Treatment Sequence C, B, and A|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence C, B, and A (please refer to the intervention descriptions). The washout period between doses will be a minimum of 10 days.
11347739|NCT04274075|BG006|Baseline|Total|Total of all reporting groups
11347740|NCT04274075|FG000|Participant Flow|GDC-9545 Treatment Sequence A, B, and C|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence A, B, and C (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347741|NCT04274075|FG001|Participant Flow|GDC-9545 Treatment Sequence B, C, and A|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence B, C, and A (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11126336|NCT01732822|OG007|Outcome|Clopidogrel - Stage IIb|Baseline Fontaine stage IIb
10857034|NCT00340834|FG002|Participant Flow|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
10857035|NCT00340834|FG003|Participant Flow|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
10857036|NCT00340834|FG004|Participant Flow|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
10857037|NCT00340834|OG000|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
10857038|NCT00340834|OG001|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
10857039|NCT00340834|OG002|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
10857040|NCT00340834|EG000|Reported Event|COR FTY720 1.25 mg|COR FTY720 1.25 mg
10857041|NCT00340834|EG001|Reported Event|COR FTY720 0.5 mg|COR FTY720 0.5 mg
10857042|NCT00340834|EG002|Reported Event|COR Interferon Beta-1a|COR Interferon beta-1a
10857043|NCT00340834|EG003|Reported Event|EXT FTY720 1.25 mg|EXT FTY720 1.25 mg
10857044|NCT00340834|EG004|Reported Event|EXT FTY720 0.5 mg|EXT FTY720 0.5 mg
10857045|NCT00342355|BG000|Baseline|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
10857046|NCT00342355|BG001|Baseline|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
10857047|NCT00342355|BG002|Baseline|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
10857048|NCT00342355|BG003|Baseline|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
10857049|NCT00342355|BG004|Baseline|Total|Total of all reporting groups
10857050|NCT00342355|FG000|Participant Flow|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
10857051|NCT00342355|FG001|Participant Flow|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
10857052|NCT00342355|FG002|Participant Flow|d4T + 3TC + EFV|Stavudine + Lamivudine + Efavirenz
10857053|NCT00342355|FG003|Participant Flow|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
10857054|NCT00342355|OG000|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
10857055|NCT00342355|OG001|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
10857056|NCT00342355|OG002|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
10857057|NCT00342355|OG003|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
10857058|NCT00342355|EG000|Reported Event|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
10857059|NCT00342355|EG001|Reported Event|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
10857060|NCT00342355|EG002|Reported Event|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
10857061|NCT00342355|EG003|Reported Event|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
10857062|NCT00342563|BG000|Baseline|Mecamylamine-Smoker|mecamylamine: mecamylamine 10mg/day
10857063|NCT00342563|BG001|Baseline|Mecamylamine-Non-Smoker|
10857064|NCT00342563|BG002|Baseline|Placebo-Smoker|Placebo: Placebo
10857065|NCT00342563|BG003|Baseline|Placebo- Non-Smoker|
10857066|NCT00342563|BG004|Baseline|Total|Total of all reporting groups
10857067|NCT00342563|FG000|Participant Flow|Mecamylamine- Smoker|mecamylamine: mecamylamine 10mg/day
10857068|NCT00342563|FG001|Participant Flow|Mecamylamine Non-Smoker|
10857069|NCT00342563|FG002|Participant Flow|Placebo Smoker|
10857070|NCT00342563|FG003|Participant Flow|Placebo Non-Smoker|
10857071|NCT00342563|OG000|Outcome|Mecamylamine- Smokers|mecamylamine: mecamylamine 10mg/day
10857072|NCT00342563|OG001|Outcome|Mecamylamine- Non-Smoker|mecamylamine: mecamylamine 10mg/day
10857073|NCT00342563|OG002|Outcome|Placebo-Smoker|Placebo
10857074|NCT00342563|OG003|Outcome|Placebo- Non-Smoker|
10857075|NCT00342563|OG000|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
10857076|NCT00342563|OG001|Outcome|Placebo|Placebo: Placebo
10857077|NCT00342563|EG000|Reported Event|Mecamylamine Smoker|mecamylamine: mecamylamine 10mg/day
10857078|NCT00342563|EG001|Reported Event|Mecamylamine Non-Smoker|mecamylamine: mecamylamine 10mg/day
10857079|NCT00342563|EG002|Reported Event|Placebo Smoker|Placebo: Placebo
10857080|NCT00342563|EG003|Reported Event|Placebo Non-Smoker|Placebo: Placebo
10857081|NCT00342628|BG000|Baseline|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
10857082|NCT00342628|BG001|Baseline|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
10857083|NCT00342628|BG002|Baseline|DTP Vaccines|DTP at 2, 4, and 6 months of age
10857084|NCT00342628|BG003|Baseline|Total|Total of all reporting groups
10857085|NCT00342628|FG000|Participant Flow|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
10857086|NCT00342628|FG001|Participant Flow|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
10857087|NCT00342628|FG002|Participant Flow|DTP Vaccines|DTP at 2, 4, and 6 months of age
10857088|NCT00342628|OG000|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
10857089|NCT00342628|OG001|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
10857090|NCT00342628|OG002|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
10857091|NCT00342628|EG000|Reported Event|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
10857092|NCT00342628|EG001|Reported Event|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
10857093|NCT00342628|EG002|Reported Event|DTP Vaccines|DTP at 2, 4, and 6 months of age
10857094|NCT00343044|BG000|Baseline|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
10857095|NCT00343044|FG000|Participant Flow|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
10857096|NCT00343044|OG000|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
10857097|NCT00343044|EG000|Reported Event|Arm 1|Patients (N=40)
10857098|NCT00343083|BG000|Baseline|Cetuximab (ERBITUX) and Concurrent Carboplatin|
10857099|NCT00343083|FG000|Participant Flow|Cetuximab (ERBITUX) and Concurrent Carboplatin|". Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy. Chemotherapy will be given every week for a total of 8 weeks. Paclitaxel will be given at a dose of 40 mg/m2 as a 1 hour infusion dose followed by cetuximab and then carboplatin AUC = 2/week.~The initial dose of cetuximab is 400 mg/m2 IV on day 1, followed by weekly infusions at 250 mg/m2 IV."
10857100|NCT00343083|OG000|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
10857101|NCT00343083|OG000|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
10857102|NCT00343083|EG000|Reported Event|Cetuximab (ERBITUX) and Concurrent Carboplatin|
10857103|NCT00343252|BG000|Baseline|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
10857104|NCT00343252|BG001|Baseline|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
10857105|NCT00343252|BG002|Baseline|Total|Total of all reporting groups
10857106|NCT00343252|FG000|Participant Flow|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
10857107|NCT00343252|FG001|Participant Flow|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
10857108|NCT00343252|OG000|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
10857109|NCT00343252|OG001|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
10857110|NCT00343252|EG000|Reported Event|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
10857111|NCT00343252|EG001|Reported Event|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
10857112|NCT00343291|BG000|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
10857113|NCT00343291|BG001|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
10857114|NCT00343291|BG002|Baseline|Total|Total of all reporting groups
10857115|NCT00343291|FG000|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
10857116|NCT00343291|FG001|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
10857117|NCT00343291|OG000|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
10857118|NCT00343291|OG001|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
11126337|NCT01732822|OG008|Outcome|Clopidogrel - Stage III|Baseline Fontaine stage III
10857119|NCT00343291|EG000|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
10857120|NCT00343291|EG001|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
10857121|NCT00343382|BG000|Baseline|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
10857122|NCT00343382|BG001|Baseline|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
10857123|NCT00343382|BG002|Baseline|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
10857124|NCT00343382|BG003|Baseline|Total|Total of all reporting groups
10857125|NCT00343382|FG000|Participant Flow|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
10857126|NCT00343382|FG001|Participant Flow|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
10857127|NCT00343382|FG002|Participant Flow|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
10857128|NCT00343382|OG000|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
10857129|NCT00343382|OG001|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
10857130|NCT00343382|OG002|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
10857131|NCT00343382|EG000|Reported Event|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
10857132|NCT00343382|EG001|Reported Event|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
10857133|NCT00343382|EG002|Reported Event|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
10857134|NCT00343460|BG000|Baseline|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
10857135|NCT00343460|BG001|Baseline|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
10857136|NCT00343460|BG002|Baseline|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
10857137|NCT00343460|BG003|Baseline|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
10857138|NCT00343460|BG004|Baseline|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
10857139|NCT00343460|BG005|Baseline|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
10857140|NCT00343460|BG006|Baseline|Total|Total of all reporting groups
10857141|NCT00343460|FG000|Participant Flow|APF530 5 mg|APF530 5 mg - Safety Population
10857142|NCT00343460|FG001|Participant Flow|APF530 10 mg|APF530 10 mg - Safety Population
10857143|NCT00343460|FG002|Participant Flow|Aloxi 0.25 mg|Aloxi 0.25 mg - Safety Population
10857144|NCT00343460|OG000|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
10857145|NCT00343460|OG001|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
10857146|NCT00343460|OG002|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
10857147|NCT00343460|OG003|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
10857148|NCT00343460|OG004|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
10857149|NCT00343460|OG005|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
10857150|NCT00343460|OG005|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
10857151|NCT00343460|OG000|Outcome|Cycles 1, 2, 3 and 4 - Moderately|APF530 5 mg
10857152|NCT00343460|OG001|Outcome|Cycles 1, 2, 3, and 4 - Moderately|APF530 10 mg
10857153|NCT00343460|OG002|Outcome|Cycles 1, 2, 3 and 4 - Highly|APF530 5 mg
10857154|NCT00343460|OG003|Outcome|Cycles 1, 2, 3, and 4 - Highly|APF530 10 mg
10857155|NCT00343460|EG000|Reported Event|Cycle 1 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
10857156|NCT00343460|EG001|Reported Event|Cycle 1 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
10857157|NCT00343460|EG002|Reported Event|Cycle 1 Aloxi 0.25 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
10857158|NCT00343460|EG003|Reported Event|Cycles 2-4 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
10857159|NCT00343460|EG004|Reported Event|Cycle 2-4 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
10857160|NCT00343512|BG000|Baseline|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
10857161|NCT00343512|FG000|Participant Flow|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
10857162|NCT00343512|OG000|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
10857163|NCT00343512|OG000|Outcome|Therapeutic Intervention|
10857164|NCT00343512|EG000|Reported Event|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
10857165|NCT00343564|BG000|Baseline|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
10857166|NCT00343564|BG001|Baseline|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
10857167|NCT00343564|BG002|Baseline|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
10857168|NCT00343564|BG003|Baseline|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
10857169|NCT00343564|BG004|Baseline|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
10857170|NCT00343564|BG005|Baseline|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
10857171|NCT00343564|BG006|Baseline|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
10857172|NCT00343564|BG007|Baseline|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
10857173|NCT00343564|BG008|Baseline|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
10857174|NCT00343564|BG009|Baseline|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
10857175|NCT00343564|BG010|Baseline|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
10857176|NCT00343564|BG011|Baseline|Total|Total of all reporting groups
10857177|NCT00343564|FG000|Participant Flow|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
10857178|NCT00343564|FG001|Participant Flow|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
10857179|NCT00343564|FG002|Participant Flow|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
10857180|NCT00343564|FG003|Participant Flow|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
10857181|NCT00343564|FG004|Participant Flow|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
10857182|NCT00343564|FG005|Participant Flow|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
10857183|NCT00343564|FG006|Participant Flow|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
10857184|NCT00343564|FG007|Participant Flow|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
10857185|NCT00343564|FG008|Participant Flow|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
10857186|NCT00343564|FG009|Participant Flow|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
10857187|NCT00343564|FG010|Participant Flow|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
10857188|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support
10857189|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support
10857190|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support
10857191|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support
10857192|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support
10857193|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support
10857194|NCT00343564|OG006|Outcome|Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
10857195|NCT00343564|OG007|Outcome|Dose Escalation Cohort 2 7mg/m2 (w/GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
10857196|NCT00343564|OG008|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
10857197|NCT00343564|OG009|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
10857198|NCT00343564|OG010|Outcome|Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
10857199|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Day 1 Cmax
10857200|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Day 1 Cmax
10857201|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Day 1 Cmax
10857202|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Day 1 Cmax
10857203|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)|Day 1 Cmax
10857204|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)|Day 1 Cmax
10857205|NCT00343564|OG006|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Day 1 Cmax
10857206|NCT00343564|OG007|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Day 1 Cmax
10857207|NCT00343564|OG008|Outcome|Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)|Day 1 Cmax
10857208|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Day 1 Tmax
10857209|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Day 1 Tmax
10857210|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Day 1 Tmax
10857211|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Day 1 Tmax
10857212|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)|Day 1 Tmax
10857213|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)|Day 1 Tmax
10857214|NCT00343564|OG006|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Day 1 Tmax
10857215|NCT00343564|OG007|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Day 1 Tmax
10857216|NCT00343564|OG008|Outcome|Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)|Day 1 Tmax
10857217|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Day 1 Clast
10857218|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Day 1 Clast
10857219|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Day 1 Clast
10857220|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Day 1 Clast
10857221|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)|Day 1 Clast
10857222|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)|Day 1 Clast
10857223|NCT00343564|OG006|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Day 1 Clast
10857224|NCT00343564|OG007|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Day 1 Clast
10857225|NCT00343564|OG008|Outcome|Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)|Day 1 Clast
10857226|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Day 1 AUClast
10857227|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Day 1 AUClast
10857228|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Day 1 AUClast
10857229|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Day 1 AUClast
10857230|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)|Day 1 AUClast
10857231|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)|Day 1 AUClast
10857232|NCT00343564|OG006|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Day 1 AUClast
10857233|NCT00343564|OG007|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Day 1 AUClast
10857234|NCT00343564|OG008|Outcome|Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)|Day 1 AUClast
10857235|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Day 15 Cmax
10857236|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Day 15 Cmax
10857237|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Day 15 Cmax
10857238|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Day 15 Cmax
10857239|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)|Day 15 Cmax
10857240|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)|Day 15 Cmax
10857241|NCT00343564|OG006|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Day 15 Cmax
10857242|NCT00343564|OG007|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Day 15 Cmax
10857243|NCT00343564|OG008|Outcome|Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)|Day 15 Cmax
10857244|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Day 15 Tmax
10857245|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Day 15 Tmax
10857246|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Day 15 Tmax
10857247|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Day 15 Tmax
10857248|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)|Day 15 Tmax
10857249|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)|Day 15 Tmax
10857250|NCT00343564|OG006|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Day 15 Tmax
10857251|NCT00343564|OG007|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Day 15 Tmax
10857252|NCT00343564|OG008|Outcome|Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)|Day 15 Tmax
10857253|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Day 15 Clast
10857254|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Day 15 Clast
10857255|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Day 15 Clast
10857256|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Day 15 Clast
10857257|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)|Day 15 Clast
10857258|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)|Day 15 Clast
10857259|NCT00343564|OG006|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Day 15 Clast
10857260|NCT00343564|OG007|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Day 15 Clast
10857261|NCT00343564|OG008|Outcome|Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)|Day 15 Clast
10857262|NCT00343564|OG000|Outcome|Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF)|Day 15 AUClast
10857263|NCT00343564|OG001|Outcome|Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)|Day 15 AUClast
10857264|NCT00343564|OG002|Outcome|Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)|Day 15 AUClast
10857265|NCT00343564|OG003|Outcome|Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)|Day 15 AUClast
10857266|NCT00343564|OG004|Outcome|Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)|Day 15 AUClast
10857267|NCT00343564|OG005|Outcome|Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)|Day 15 AUClast
10857268|NCT00343564|OG006|Outcome|Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)|Day 15 AUClast
10857269|NCT00343564|OG007|Outcome|Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)|Day 15 AUClast
10857270|NCT00343564|EG000|Reported Event|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
10857271|NCT00343564|EG001|Reported Event|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
10857272|NCT00343564|EG002|Reported Event|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
10857273|NCT00343564|EG003|Reported Event|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
10857274|NCT00343564|EG004|Reported Event|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
10857275|NCT00343564|EG005|Reported Event|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
10857276|NCT00343564|EG006|Reported Event|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
10857277|NCT00343564|EG007|Reported Event|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
10857278|NCT00343564|EG008|Reported Event|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
10857279|NCT00343564|EG009|Reported Event|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
10857280|NCT00343564|EG010|Reported Event|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
10857281|NCT00343642|BG000|Baseline|Time and Attention + Active Fructooligosaccharide Supplement.|"Time and attention + active fructooligosaccharide supplement.~Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily"
10857282|NCT00343642|BG001|Baseline|Time and Attention + Fructooligosaccharide Placebo|"Time and attention + fructooligosaccharide placebo~Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily"
10857283|NCT00343642|BG002|Baseline|Dietary Therapy + Fructooligosaccharide Placebo|"Dietary therapy + fructooligosaccharide placebo~dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder"
10857284|NCT00343642|BG003|Baseline|Total|Total of all reporting groups
10857285|NCT00343642|FG000|Participant Flow|Time and Attention and Active Fructo-oligosaccharide|Subjects received an active prebiotic fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans
10857286|NCT00343642|FG001|Participant Flow|Time and Attention and Fructo-oligosaccharide Placebo|Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
10857287|NCT00343642|FG002|Participant Flow|Dietary Therapy and Fructo-oligosaccharide Placebo|Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.
10857288|NCT00343642|OG000|Outcome|Time and Attention + Active Fructooligosaccharide Supplement|"Time and attention + active fructooligosaccharide supplement.~Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily"
10857289|NCT00343642|OG001|Outcome|Time and Attention + Fructooligosaccharide Placebo|"Time and attention + fructooligosaccharide placebo~Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily"
10857290|NCT00343642|OG002|Outcome|Dietary Therapy + Fructooligosaccharide Placebo|"Dietary therapy + fructooligosaccharide placebo~dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder"
10857291|NCT00343642|OG000|Outcome|Time and Attention and Active Fructooligosaccharide Supplement|Subjects received an active prebiotic fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
10857292|NCT00343642|OG001|Outcome|Time and Attention and Fructo-oligosaccharide Placebo|Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
10857293|NCT00343642|OG002|Outcome|Dietary Therapy and Fructooligosaccharide Placebo|Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.
10857294|NCT00343642|EG000|Reported Event|Time and Attention + Active Fructooligosaccharide Supplement.|"Time and attention + active fructooligosaccharide supplement.~Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily"
10857295|NCT00343642|EG001|Reported Event|Time and Attention + Fructooligosaccharide Placebo|"Time and attention + fructooligosaccharide placebo~Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily"
10857296|NCT00343642|EG002|Reported Event|Dietary Therapy + Fructooligosaccharide Placebo|"Dietary therapy + fructooligosaccharide placebo~dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder"
10857297|NCT00343785|BG000|Baseline|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
10857298|NCT00343785|FG000|Participant Flow|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
10857299|NCT00343785|OG000|Outcome|Patients Receive a Conditioning Regimen Comprising Cyclophosph|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
10857300|NCT00343785|OG000|Outcome|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
10857301|NCT00343785|EG000|Reported Event|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
10857302|NCT00343863|BG000|Baseline|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
10857303|NCT00343863|BG001|Baseline|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
10857304|NCT00343863|BG002|Baseline|Total|Total of all reporting groups
10857305|NCT00343863|FG000|Participant Flow|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
10857306|NCT00343863|FG001|Participant Flow|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
10857307|NCT00343863|OG000|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
11126338|NCT01732822|OG009|Outcome|Clopidogrel - Stage IV|Baseline Fontaine stage IV
11126339|NCT01732822|OG000|Outcome|Ticagrelor - Cat 0|Baseline Rutherford category 0
11126340|NCT01732822|OG001|Outcome|Ticagrelor - Stage II|Baseline Rutherford category 1/2
11126341|NCT01732822|OG002|Outcome|Ticagrelor - Cat 3|Baseline Rutherford category 3
11126342|NCT01732822|OG003|Outcome|Ticagrelor - Cat 4|Baseline Rutherford category 4
10976852|NCT00942357|EG001|Reported Event|Arm II (Paclitaxel and Carboplatin)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10976853|NCT00942422|BG000|Baseline|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal). Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10976854|NCT00942422|FG000|Participant Flow|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10976855|NCT00942422|OG000|Outcome|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~defined green tea catechin extract: Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
11126343|NCT01732822|OG004|Outcome|Ticagrelor - Cat 5|Baseline Rutherford category 5
11126344|NCT01732822|OG005|Outcome|Ticagrelor - Cat 6|Baseline Rutherford category 6
11126345|NCT01732822|OG006|Outcome|Clopidogrel - Cat 0|Baseline Rutherford category 0
11126346|NCT01732822|OG007|Outcome|Clopidogrel - Cat 1/2|Baseline Rutherford category 1/2
11126347|NCT01732822|OG008|Outcome|Clopidogrel - Cat 3|Baseline Rutherford category 3
10857308|NCT00343863|OG001|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
10857309|NCT00343863|OG000|Outcome|Dexamethasone + Ondansetron IV|Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
10857310|NCT00343863|OG001|Outcome|Dexamethasone + Palonosetron IV|Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
10857311|NCT00343863|EG000|Reported Event|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
10857312|NCT00343863|EG001|Reported Event|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
10857313|NCT00343889|BG000|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
10857314|NCT00343889|BG001|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
10857315|NCT00343889|BG002|Baseline|Total|Total of all reporting groups
10857316|NCT00343889|FG000|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
10857317|NCT00343889|FG001|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
10857318|NCT00343889|OG000|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
10857319|NCT00343889|OG001|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
10857320|NCT00343889|EG000|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
10857321|NCT00343889|EG001|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
10857322|NCT00343915|BG000|Baseline|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
10857323|NCT00343915|BG001|Baseline|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
10857324|NCT00343915|BG002|Baseline|Total|Total of all reporting groups
10857325|NCT00343915|FG000|Participant Flow|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
10857326|NCT00343915|FG001|Participant Flow|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
10857327|NCT00343915|OG000|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
10857328|NCT00343915|OG001|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
10857329|NCT00343915|OG000|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
10857330|NCT00343915|OG001|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
10857331|NCT00343915|OG001|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
10857332|NCT00343915|EG000|Reported Event|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
10857333|NCT00343915|EG001|Reported Event|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
10857334|NCT00344032|BG000|Baseline|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
10857335|NCT00344032|BG001|Baseline|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
10857336|NCT00344032|BG002|Baseline|Total|Total of all reporting groups
10857337|NCT00344032|FG000|Participant Flow|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
10857338|NCT00344032|FG001|Participant Flow|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
10857339|NCT00344032|OG000|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
10857340|NCT00344032|OG001|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
10857341|NCT00344032|EG000|Reported Event|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
10857342|NCT00344032|EG001|Reported Event|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
10857343|NCT00344175|BG000|Baseline|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
10857344|NCT00344175|BG001|Baseline|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
10857345|NCT00344175|BG002|Baseline|Total|Total of all reporting groups
10857346|NCT00344175|FG000|Participant Flow|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
10857347|NCT00344175|FG001|Participant Flow|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
10857348|NCT00344175|OG000|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
10857349|NCT00344175|OG001|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
10857350|NCT00344175|EG000|Reported Event|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
10857351|NCT00344175|EG001|Reported Event|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
10857352|NCT00344305|BG000|Baseline|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857353|NCT00344305|BG001|Baseline|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857354|NCT00344305|BG002|Baseline|Total|Total of all reporting groups
10857355|NCT00344305|FG000|Participant Flow|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857356|NCT00344305|FG001|Participant Flow|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857357|NCT00344305|OG000|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857358|NCT00344305|OG001|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857359|NCT00344305|OG000|Outcome|All Participants|Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857360|NCT00344305|EG000|Reported Event|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857361|NCT00344305|EG001|Reported Event|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
10857362|NCT00344318|BG000|Baseline|Synflorix 1 Group|Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.
10857363|NCT00344318|BG001|Baseline|Synflorix 2 Group|Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.
10857364|NCT00344318|BG002|Baseline|Prevenar 1 Group|Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.
10857365|NCT00344318|BG003|Baseline|Prevenar 2 Group|Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
10857366|NCT00344318|BG004|Baseline|Total|Total of all reporting groups
10857367|NCT00344318|FG000|Participant Flow|Synflorix 1 Group|Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.
10857368|NCT00344318|FG001|Participant Flow|Synflorix 2 Group|Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.
10857369|NCT00344318|FG002|Participant Flow|Prevenar 1 Group|Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.
10857370|NCT00344318|FG003|Participant Flow|Prevenar 2 Group|Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
10857371|NCT00344318|OG000|Outcome|Synflorix Pooled Group|Synflorix 1 Group and Synflorix 2 Group pooled together
10857372|NCT00344318|OG001|Outcome|Prevenar Pooled Group|Prevenar 1 Group and Prevenar 2 Group pooled together
10857373|NCT00344318|OG000|Outcome|Synflorix 1 Group|Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.
10857374|NCT00344318|OG001|Outcome|Synflorix 2 Group|Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.
10857375|NCT00344318|OG002|Outcome|Prevenar 1 Group|Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.
10857376|NCT00344318|OG003|Outcome|Prevenar 2 Group|Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
10857377|NCT00344318|EG000|Reported Event|Synflorix 1 Group|Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.
10857378|NCT00344318|EG001|Reported Event|Synflorix 2 Group|Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.
10857379|NCT00344318|EG002|Reported Event|Prevenar 1 Group|Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.
10857380|NCT00344318|EG003|Reported Event|Prevenar 2 Group|Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
10857381|NCT00344370|BG000|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10857382|NCT00344370|BG001|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
10857383|NCT00344370|BG002|Baseline|Total|Total of all reporting groups
10857384|NCT00344370|FG000|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10857385|NCT00344370|FG001|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
10857386|NCT00344370|OG000|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10857387|NCT00344370|OG001|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
10857388|NCT00344370|EG000|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10857389|NCT00344370|EG001|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
10857390|NCT00344448|BG000|Baseline|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
10857391|NCT00344448|BG001|Baseline|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
10857392|NCT00344448|BG002|Baseline|Total|Total of all reporting groups
10857393|NCT00344448|FG000|Participant Flow|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
10857394|NCT00344448|FG001|Participant Flow|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
10857395|NCT00344448|OG000|Outcome|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
10857396|NCT00344448|OG001|Outcome|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
10857397|NCT00344448|EG000|Reported Event|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
10857398|NCT00344448|EG001|Reported Event|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
10857399|NCT00344461|BG000|Baseline|TDF, FTC & NVP|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
10857400|NCT00344461|FG000|Participant Flow|Single Group (TDF/FTC & NVP)|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
10857401|NCT00344461|OG000|Outcome|Single Group (TDF/FTC & NVP)|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
10857402|NCT00344461|OG000|Outcome|Nevirapine, FTC, Tenofovir|"Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.~Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d."
10857403|NCT00344461|EG000|Reported Event|FTC, TDF, & NVP|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
10857404|NCT00344500|BG000|Baseline|Usual Care|Usual Care control group
10857405|NCT00344500|BG001|Baseline|Lifestyle Balance|Weight management education and counseling
10857406|NCT00344500|BG002|Baseline|Total|Total of all reporting groups
10857407|NCT00344500|FG000|Participant Flow|Usual Care|Usual Care control group
10857408|NCT00344500|FG001|Participant Flow|Lifestyle Balance|"Weight management education and counseling~Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
10857409|NCT00344500|FG002|Participant Flow|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
10857410|NCT00344500|OG000|Outcome|Usual Care (UC)|Usual Care control group
10857411|NCT00344500|OG001|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
10857412|NCT00344500|EG000|Reported Event|Usual Care|Usual Care control group
10857413|NCT00344500|EG001|Reported Event|Lifestyle Balance|"Weight management education and counseling~Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
10857414|NCT00344500|EG002|Reported Event|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
10857415|NCT00344682|BG000|Baseline|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
10857416|NCT00344682|BG001|Baseline|Memantine|memantine : memantine 5mg - 20mg PO daily
10857417|NCT00344682|BG002|Baseline|Total|Total of all reporting groups
10857418|NCT00344682|FG000|Participant Flow|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
10857419|NCT00344682|FG001|Participant Flow|Memantine|memantine : memantine 5mg - 20mg PO daily
10857420|NCT00344682|OG000|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
10857421|NCT00344682|OG001|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
10857422|NCT00344682|EG000|Reported Event|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
10857423|NCT00344682|EG001|Reported Event|Memantine|memantine : memantine 5mg - 20mg PO daily
10857424|NCT00344773|BG000|Baseline|Gefitinib|Gefitinib 250mg tablet
10857425|NCT00344773|FG000|Participant Flow|Gefitinib|Gefitinib 250mg tablet
10857426|NCT00344773|OG000|Outcome|Gefitinib|Gefitinib 250mg tablet
10857427|NCT00344773|EG000|Reported Event|Gefitinib|Gefitinib 250mg tablet
10857428|NCT00344968|BG000|Baseline|Sham Comparator|Procedure: Standard of care laser photocoagulation
10857429|NCT00344968|BG001|Baseline|0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
10857430|NCT00344968|BG002|Baseline|0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
10857431|NCT00344968|BG003|Baseline|Total|Total of all reporting groups
10857432|NCT00344968|FG000|Participant Flow|Sham Comparator|Procedure: Standard of care laser photocoagulation
10857433|NCT00344968|FG001|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
10857434|NCT00344968|FG002|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
10857435|NCT00344968|OG000|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
10857436|NCT00344968|OG001|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
10857437|NCT00344968|OG002|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
10857438|NCT00344968|OG001|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
10857439|NCT00344968|EG000|Reported Event|Sham Comparator|Standard of care laser photocoagulation
10857440|NCT00344968|EG001|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
10857441|NCT00344968|EG002|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
10857442|NCT00345033|BG000|Baseline|Aripiprazole|Participants will take aripiprazole for 8 weeks.
10857443|NCT00345033|BG001|Baseline|Placebo|Participants will take placebo for 8 weeks.
10857444|NCT00345033|BG002|Baseline|Total|Total of all reporting groups
10857445|NCT00345033|FG000|Participant Flow|Aripiprazole|Participants will take aripiprazole for 8 weeks.
10857446|NCT00345033|FG001|Participant Flow|Placebo|Participants will take placebo for 8 weeks.
10857447|NCT00345033|OG000|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
10857448|NCT00345033|OG001|Outcome|Placebo|Participants will take placebo for 8 weeks.
10857449|NCT00345033|EG000|Reported Event|Aripiprazole|Participants will take aripiprazole for 8 weeks.
10857450|NCT00345033|EG001|Reported Event|Placebo|Participants will take placebo for 8 weeks.
10857451|NCT00345046|BG000|Baseline|Pred Forte|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.~Pred Forte: Four drops daily decreasing to once daily over four weeks."
10857452|NCT00345046|BG001|Baseline|EconoPred Plus|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
10857453|NCT00345046|BG002|Baseline|Prednisolone Acetate|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
10857454|NCT00345046|BG003|Baseline|Total|Total of all reporting groups
10857455|NCT00345046|FG000|Participant Flow|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
10857456|NCT00345046|FG001|Participant Flow|EconPred Plus 1%|EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
10857457|NCT00345046|FG002|Participant Flow|Prednisolone Acetate 1%|Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
10857458|NCT00345046|OG000|Outcome|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
10857459|NCT00345046|OG001|Outcome|Econo Pred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
10857460|NCT00345046|OG002|Outcome|Predisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
10857461|NCT00345046|EG000|Reported Event|Pred Forte 1%|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.~Pred Forte: Four drops daily decreasing to once daily over four weeks."
10857462|NCT00345046|EG001|Reported Event|EconoPred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
10857463|NCT00345046|EG002|Reported Event|Prednisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
10857464|NCT00345176|BG000|Baseline|Placebo/Control|Considered control because all participants received the AREDS formulation
10857465|NCT00345176|BG001|Baseline|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
10857466|NCT00345176|BG002|Baseline|DHA/EPA|DHA (350 mg)/EPA (650 mg)
10857467|NCT00345176|BG003|Baseline|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
10857468|NCT00345176|BG004|Baseline|Total|Total of all reporting groups
10857469|NCT00345176|FG000|Participant Flow|Placebo/Control|Considered control because all participants received the AREDS formulation
10857470|NCT00345176|FG001|Participant Flow|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
10857471|NCT00345176|FG002|Participant Flow|DHA/EPA|DHA (350 mg)/EPA (650 mg)
10857472|NCT00345176|FG003|Participant Flow|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
10857473|NCT00345176|OG000|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
10857474|NCT00345176|OG001|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
10857475|NCT00345176|OG002|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
10857476|NCT00345176|OG003|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
10857477|NCT00345176|OG000|Outcome|No Lutein/Zeaxanthin|Lutein main effect - includes participants who did not receive Lutein/Zeaxanthin
10857478|NCT00345176|OG001|Outcome|Lutein/Zeaxanthin|Lutein main effect - includes all participants who received Lutein/Zeaxanthin
10857479|NCT00345176|EG000|Reported Event|Placebo/Control|Considered control because all participants received the AREDS formulation
10857480|NCT00345176|EG001|Reported Event|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
10857481|NCT00345176|EG002|Reported Event|DHA/EPA|DHA (350 mg)/EPA (650 mg)
10857482|NCT00345176|EG003|Reported Event|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
10857483|NCT00345254|BG000|Baseline|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
10857484|NCT00345254|BG001|Baseline|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
10857485|NCT00345254|BG002|Baseline|Total|Total of all reporting groups
10857486|NCT00345254|FG000|Participant Flow|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
10857487|NCT00345254|FG001|Participant Flow|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
10857488|NCT00345254|OG000|Outcome|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
10857489|NCT00345254|OG001|Outcome|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
10857490|NCT00345254|EG000|Reported Event|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
10857491|NCT00345254|EG001|Reported Event|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
10857492|NCT00345293|BG000|Baseline|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
10857493|NCT00345293|FG000|Participant Flow|DC/PC3 Vaccine-selected|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using antibodies.
10857494|NCT00345293|FG001|Participant Flow|DC/PC3- Adherent|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using the adherence method.
10857495|NCT00345293|OG000|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
11126348|NCT01732822|OG009|Outcome|Clopidogrel - Cat 4|Baseline Rutherford category 4
11126349|NCT01732822|OG010|Outcome|Clopidogrel - Cat 5|Baseline Rutherford category 5
10848859|NCT00292162|FG001|Participant Flow|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
11126350|NCT01732822|OG011|Outcome|Clopidogrel - Cat 6|Baseline Rutherford category 6
11126351|NCT01732822|EG000|Reported Event|Clopidogrel 75mg od|
11126352|NCT01732822|EG001|Reported Event|Ticagrelor 90mg bd|
10857496|NCT00345293|OG000|Outcome|DC/PC3 Vaccine- Selected|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).~Dendritic cells were made from antibody selected cells."
10857497|NCT00345293|OG001|Outcome|DC/PC3- Adherent|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).~Dendritic cells were made from the adherent subset of peripheral blood mononuclear cells."
10857498|NCT00345293|EG000|Reported Event|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
10857499|NCT00345332|BG000|Baseline|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
10857500|NCT00345332|BG001|Baseline|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
10857501|NCT00345332|BG002|Baseline|Total|Total of all reporting groups
10857502|NCT00345332|FG000|Participant Flow|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
10857503|NCT00345332|FG001|Participant Flow|Botox Group|Botox (BTX) was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
10857504|NCT00345332|OG000|Outcome|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
10857505|NCT00345332|OG001|Outcome|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
10857506|NCT00345332|EG000|Reported Event|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
10857507|NCT00345332|EG001|Reported Event|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
10857508|NCT00345371|BG000|Baseline|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
10857509|NCT00345371|BG001|Baseline|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
10857510|NCT00345371|BG002|Baseline|Total|Total of all reporting groups
10857511|NCT00345371|FG000|Participant Flow|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
10857512|NCT00345371|FG001|Participant Flow|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
10857513|NCT00345371|OG000|Outcome|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
10857514|NCT00345371|OG001|Outcome|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
10857515|NCT00345371|EG000|Reported Event|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
10857516|NCT00345371|EG001|Reported Event|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
10857517|NCT00345384|BG000|Baseline|Normal Saline|Standard of care
10857518|NCT00345384|BG001|Baseline|Dexmedetomidine|titrated IV for 24 hours post ICU
10857519|NCT00345384|BG002|Baseline|Total|Total of all reporting groups
10857520|NCT00345384|FG000|Participant Flow|Normal Saline|Blinded Normal saline infusion titrated as if study drug
10857521|NCT00345384|FG001|Participant Flow|Dexmedetomidine|Received Dexmedetomidine for 24 hours
10857522|NCT00345384|OG000|Outcome|Placebo|Patient group to receive placebo (saline).
10857523|NCT00345384|OG001|Outcome|Dexmedetomidine|Patient group to receive Dexmedetomidine.
10857524|NCT00345384|OG000|Outcome|Placebo|Control group to receive a normal saline infusion, set at a rate as if it were the active drug.
10857525|NCT00345384|OG001|Outcome|Dexmedetomidine|"Study group to receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 30 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU~Dexmedetomidine: Dexmedetomidine titrated over 24 hours"
10857526|NCT00345384|EG000|Reported Event|Normal Saline Group|Normal saline infused at calculated rate as if it were study drug
10857527|NCT00345384|EG001|Reported Event|Study Drug Group|Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU
10857528|NCT00345397|BG000|Baseline|Subjects Receiving Percutaneous Endoscopic Colostomy (PEC)|Quality of Life (QOL) evaluation before and after device placement
10857529|NCT00345397|FG000|Participant Flow|Subjects Receiving PEC Tube|All Enrolled Subjects receiving PEC Placement
10857530|NCT00345397|OG000|Outcome|Global SCI-QoL Score in Subjects Receiving PEC Tube|Global SCI-QoL Score before and after device placement
10857531|NCT00345397|OG001|Outcome|SCI-Specific QoL Evaluation in Subjects Receiving PEC Tube|SCI-Specific QoL evaluation before and after device placement
10857532|NCT00345397|EG000|Reported Event|Subjects Receiving PEC Tube|QoL evaluation before and after device placement
10857533|NCT00345540|BG000|Baseline|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
10857534|NCT00345540|FG000|Participant Flow|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
10857535|NCT00345540|OG000|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
10857536|NCT00345540|EG000|Reported Event|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
10857537|NCT00345579|BG000|Baseline|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857538|NCT00345579|BG001|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857539|NCT00345579|BG002|Baseline|Total|Total of all reporting groups
10857540|NCT00345579|FG000|Participant Flow|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857541|NCT00345579|FG001|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857542|NCT00345579|OG000|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857543|NCT00345579|OG001|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857544|NCT00345579|OG000|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857545|NCT00345579|EG000|Reported Event|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857546|NCT00345579|EG001|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857547|NCT00345592|BG000|Baseline|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
10857548|NCT00345592|BG001|Baseline|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
10857549|NCT00345592|BG002|Baseline|Total|Total of all reporting groups
10857550|NCT00345592|FG000|Participant Flow|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
10878921|NCT00454649|OG001|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
10857551|NCT00345592|FG001|Participant Flow|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
10857552|NCT00345592|OG000|Outcome|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
10857553|NCT00345592|OG001|Outcome|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
10857554|NCT00345592|EG000|Reported Event|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
10857555|NCT00345592|EG001|Reported Event|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
10857556|NCT00345605|BG000|Baseline|High-dose Arginine vs Low-dose Arginine Plus Buphenyl|
10857557|NCT00345605|FG000|Participant Flow|High Dose First|High dose arm 3 day wash-out followed by 7 days of: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA interval then: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA
10857558|NCT00345605|FG001|Participant Flow|Low Dose First|low dose arm 3 day wash-out followed by 7 days of: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA interval then: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA
10857559|NCT00345605|OG000|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
10857560|NCT00345605|OG001|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
10857561|NCT00345605|OG000|Outcome|High-dose Arginine Alone|
10857562|NCT00345605|OG001|Outcome|Low-dose Arginine Plus Buphenyl|
10857563|NCT00345605|EG000|Reported Event|High-dose Arginine Alone|
10857564|NCT00345605|EG001|Reported Event|Low-dose Arginine Plus Buphenyl|
10857565|NCT00345631|BG000|Baseline|Roll-In|Roll-In patients were device training patients
10857566|NCT00345631|BG001|Baseline|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
10857567|NCT00345631|BG002|Baseline|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
10857568|NCT00345631|BG003|Baseline|Total|Total of all reporting groups
10857569|NCT00345631|FG000|Participant Flow|Roll-In|Roll-In patients were device training patients
10857570|NCT00345631|FG001|Participant Flow|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
10857571|NCT00345631|FG002|Participant Flow|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
10857572|NCT00345631|OG000|Outcome|Roll-In|patients were device training patients
10857573|NCT00345631|OG001|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
10857574|NCT00345631|OG002|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
10857575|NCT00345631|OG000|Outcome|Roll-In|Roll-In patients were device training patients
10857576|NCT00345631|OG002|Outcome|Manual Compression (Not Applicable for Device Success)|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
10857577|NCT00345631|EG000|Reported Event|Roll-In|Roll-In patients were device training patients
10857578|NCT00345631|EG001|Reported Event|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
10857579|NCT00345631|EG002|Reported Event|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
10857580|NCT00345683|BG000|Baseline|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857581|NCT00345683|BG001|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857582|NCT00345683|BG002|Baseline|Total|Total of all reporting groups
10857583|NCT00345683|FG000|Participant Flow|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857584|NCT00345683|FG001|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857585|NCT00345683|OG000|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857586|NCT00345683|OG001|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857587|NCT00345683|EG000|Reported Event|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857588|NCT00345683|EG001|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
10857589|NCT00345839|BG000|Baseline|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
10857590|NCT00345839|BG001|Baseline|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
10857591|NCT00345839|BG002|Baseline|Total|Total of all reporting groups
10857592|NCT00345839|FG000|Participant Flow|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
10857593|NCT00345839|FG001|Participant Flow|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
10857594|NCT00345839|OG000|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
10857595|NCT00345839|OG001|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
10857596|NCT00345839|EG000|Reported Event|Placebo|
10857597|NCT00345839|EG001|Reported Event|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
10857598|NCT00345865|BG000|Baseline|NHL With Irradiation|Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
10857599|NCT00345865|BG001|Baseline|HL Without Irradiation|Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
10857600|NCT00345865|BG002|Baseline|NHL - HIV Infected With Irradiation|Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
10857601|NCT00345865|BG003|Baseline|NHL - HIV Infected Without Irradiation|Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
10857602|NCT00345865|BG004|Baseline|NHL Without Radiation and Cyclophosphamide|Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
10857603|NCT00345865|BG005|Baseline|Total|Total of all reporting groups
10857604|NCT00345865|FG000|Participant Flow|NHL With Irradiation|Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
10857605|NCT00345865|FG001|Participant Flow|HL Without Irradiation|Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
10857606|NCT00345865|FG002|Participant Flow|NHL - HIV Infected With Irradiation|Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
10857607|NCT00345865|FG003|Participant Flow|NHL - HIV Infected Without Irradiation|Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
10857608|NCT00345865|FG004|Participant Flow|NHL Without Radiation and Cyclophosphamide|Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
10857609|NCT00345865|OG000|Outcome|NHL With Irradiation|Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
10857610|NCT00345865|OG001|Outcome|HL Without Irradiation|Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
10857611|NCT00345865|OG002|Outcome|NHL - HIV Infected With Irradiation|Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
10857612|NCT00345865|OG003|Outcome|NHL - HIV Infected Without Irradiation|Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
10857613|NCT00345865|OG004|Outcome|NHL Without Radiation and Cyclophosphamide|Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
10857614|NCT00345865|EG000|Reported Event|NHL With Irradiation|Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
10857615|NCT00345865|EG001|Reported Event|HL Without Irradiation|Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
10857616|NCT00345865|EG002|Reported Event|NHL - HIV Infected With Irradiation|Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
10857617|NCT00345865|EG003|Reported Event|NHL - HIV Infected Without Irradiation|Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
10857618|NCT00345865|EG004|Reported Event|NHL Without Radiation and Cyclophosphamide|Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
10857619|NCT00345878|BG000|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
10857620|NCT00345878|BG001|Baseline|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
10857621|NCT00345878|BG002|Baseline|Total|Total of all reporting groups
10857622|NCT00345878|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
10857623|NCT00345878|FG001|Participant Flow|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
10857624|NCT00345878|OG000|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
10857625|NCT00345878|OG001|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
10857626|NCT00345878|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
10857627|NCT00345878|EG001|Reported Event|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
10857628|NCT00345969|BG000|Baseline|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
10857629|NCT00345969|BG001|Baseline|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
10857630|NCT00345969|BG002|Baseline|Total|Total of all reporting groups
10857631|NCT00345969|FG000|Participant Flow|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
10857632|NCT00345969|FG001|Participant Flow|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
10857633|NCT00345969|OG000|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
10857634|NCT00345969|OG001|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
10857635|NCT00345969|EG000|Reported Event|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
10857636|NCT00345969|EG001|Reported Event|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
10857637|NCT00346034|BG000|Baseline|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
10857638|NCT00346034|FG000|Participant Flow|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
10857639|NCT00346034|OG000|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
10857640|NCT00346034|EG000|Reported Event|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
10857641|NCT00346073|BG000|Baseline|Boostrix Group|Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
10857642|NCT00346073|BG001|Baseline|Adacel Group|Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
10857643|NCT00346073|BG002|Baseline|Total|Total of all reporting groups
10857644|NCT00346073|FG000|Participant Flow|Boostrix Group|Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
10857645|NCT00346073|FG001|Participant Flow|Adacel Group|Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
10857646|NCT00346073|OG000|Outcome|Boostrix Group|Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
10857647|NCT00346073|OG001|Outcome|Adacel Group|Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
10857648|NCT00346073|EG000|Reported Event|Boostrix Group|Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
10857649|NCT00346073|EG001|Reported Event|Adacel Group|Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
10857650|NCT00346151|BG000|Baseline|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
10857651|NCT00346151|FG000|Participant Flow|Belatacept|Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
10857652|NCT00346151|OG000|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
10857653|NCT00346151|EG000|Reported Event|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
10857654|NCT00346216|BG000|Baseline|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
10857655|NCT00346216|BG001|Baseline|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
10857656|NCT00346216|BG002|Baseline|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
10857657|NCT00346216|BG003|Baseline|Total|Total of all reporting groups
10857658|NCT00346216|FG000|Participant Flow|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
10857659|NCT00346216|FG001|Participant Flow|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
10857660|NCT00346216|FG002|Participant Flow|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
10857661|NCT00346216|OG000|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
10857662|NCT00346216|OG001|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
10857663|NCT00346216|OG002|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
10857664|NCT00346216|EG000|Reported Event|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
10857665|NCT00346216|EG001|Reported Event|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
10857666|NCT00346216|EG002|Reported Event|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
10857667|NCT00346268|BG000|Baseline|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
10857668|NCT00346268|BG001|Baseline|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
10857669|NCT00346268|BG002|Baseline|Total|Total of all reporting groups
10857670|NCT00346268|FG000|Participant Flow|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
10857671|NCT00346268|FG001|Participant Flow|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
10857672|NCT00346268|OG000|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
10857673|NCT00346268|OG001|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
10857674|NCT00346268|EG000|Reported Event|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
10857675|NCT00346268|EG001|Reported Event|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
10857676|NCT00346333|BG000|Baseline|Control Plus Vitamin A|cornstarch control plus 15,000IU Vitamin A palmitate daily
10857677|NCT00346333|BG001|Baseline|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A palmitate daily
10857678|NCT00346333|BG002|Baseline|Total|Total of all reporting groups
10857679|NCT00346333|FG000|Participant Flow|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
10857680|NCT00346333|FG001|Participant Flow|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
10857681|NCT00346333|OG000|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
10857682|NCT00346333|OG001|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
10857683|NCT00346333|OG000|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
10857684|NCT00346333|OG001|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
10857685|NCT00346333|EG000|Reported Event|Control Plus Vitamin A|Daily intake of cornstarch control plus 15,000IU Vitamin A palmitate
10857686|NCT00346333|EG001|Reported Event|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A daily.
10857687|NCT00346398|BG000|Baseline|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
10857688|NCT00346398|BG001|Baseline|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
10857689|NCT00346398|BG002|Baseline|Total|Total of all reporting groups
10857690|NCT00346398|FG000|Participant Flow|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
10857691|NCT00346398|FG001|Participant Flow|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
10857692|NCT00346398|OG000|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
10857693|NCT00346398|OG001|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
10857694|NCT00346398|EG000|Reported Event|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
10857695|NCT00346398|EG001|Reported Event|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
10857696|NCT00346476|BG000|Baseline|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
10857697|NCT00346476|FG000|Participant Flow|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
10857698|NCT00346476|OG000|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
10857699|NCT00346476|EG000|Reported Event|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
10857700|NCT00346632|BG000|Baseline|Arm A: KW-2449 14-day Regimen|Sequential ascending oral doses of KW-2449 given for 14-day cycles
10857701|NCT00346632|BG001|Baseline|Arm B: KW-2449 28-day Regimen|Sequential ascending oral doses of KW-2449 given for 28-day cycles
10857702|NCT00346632|BG002|Baseline|Total|Total of all reporting groups
10857703|NCT00346632|FG000|Participant Flow|25 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
10857704|NCT00346632|FG001|Participant Flow|50 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
10857705|NCT00346632|FG002|Participant Flow|100 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
10857706|NCT00346632|FG003|Participant Flow|200 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
10857707|NCT00346632|FG004|Participant Flow|300 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
10857708|NCT00346632|FG005|Participant Flow|400 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
10857709|NCT00346632|FG006|Participant Flow|500 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
10857710|NCT00346632|FG007|Participant Flow|25 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
10857711|NCT00346632|FG008|Participant Flow|50 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
10857712|NCT00346632|FG009|Participant Flow|100 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
10857713|NCT00346632|OG000|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
10857714|NCT00346632|OG001|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
10857715|NCT00346632|OG002|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
10857716|NCT00346632|OG003|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
10857717|NCT00346632|OG004|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
10857718|NCT00346632|OG005|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
10857719|NCT00346632|OG006|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
10857720|NCT00346632|OG007|Outcome|Arm A - Total|Total Patients in Treatment Arm A
10857721|NCT00346632|OG008|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
10857722|NCT00346632|OG009|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
10857723|NCT00346632|OG010|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
10857724|NCT00346632|OG011|Outcome|Arm B - Total|Total Patients in Treatment Arm B
10857725|NCT00346632|OG000|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
10857726|NCT00346632|OG001|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
10857727|NCT00346632|OG002|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
10857728|NCT00346632|OG003|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
10857729|NCT00346632|OG004|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
10857730|NCT00346632|OG005|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
10857731|NCT00346632|OG006|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
10857732|NCT00346632|OG007|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
10857733|NCT00346632|OG008|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
10857734|NCT00346632|OG009|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
10857735|NCT00346632|OG010|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
10857736|NCT00346632|OG011|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
10857737|NCT00346632|OG012|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
10857738|NCT00346632|OG013|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
10857739|NCT00346632|OG014|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
10857740|NCT00346632|OG015|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
10857741|NCT00346632|OG016|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
10857742|NCT00346632|OG017|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
10857743|NCT00346632|OG018|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
10857744|NCT00346632|OG019|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
10857745|NCT00346632|OG020|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
10857746|NCT00346632|OG021|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
10857747|NCT00346632|OG022|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
10857748|NCT00346632|OG000|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
10857749|NCT00346632|OG001|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
10857750|NCT00346632|OG002|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
10857751|NCT00346632|OG003|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
10857752|NCT00346632|OG004|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
10857753|NCT00346632|OG005|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
10857754|NCT00346632|OG006|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
10857755|NCT00346632|OG007|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
10857756|NCT00346632|OG008|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
10857757|NCT00346632|OG009|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
10857758|NCT00346632|OG010|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
10857759|NCT00346632|OG011|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
10857760|NCT00346632|OG012|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
10857761|NCT00346632|EG000|Reported Event|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
10857762|NCT00346632|EG001|Reported Event|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
10857763|NCT00346632|EG002|Reported Event|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
10857764|NCT00346632|EG003|Reported Event|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
10857765|NCT00346632|EG004|Reported Event|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
10857766|NCT00346632|EG005|Reported Event|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
10857767|NCT00346632|EG006|Reported Event|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
10857768|NCT00346632|EG007|Reported Event|Arm A - Total|Total Patients in Treatment Arm A
10857769|NCT00346632|EG008|Reported Event|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
10857770|NCT00346632|EG009|Reported Event|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
10857771|NCT00346632|EG010|Reported Event|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
10857772|NCT00346632|EG011|Reported Event|Arm B - Total|Total Patients in Treatment Arm B
10857773|NCT00346697|BG000|Baseline|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
10857774|NCT00346697|BG001|Baseline|Placebo|Corn oil placebo, plus dietary counselling
10857775|NCT00346697|BG002|Baseline|Total|Total of all reporting groups
10857776|NCT00346697|FG000|Participant Flow|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
10857777|NCT00346697|FG001|Participant Flow|Placebo|Corn oil placebo, plus dietary counselling
10857778|NCT00346697|OG000|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
10857779|NCT00346697|OG001|Outcome|Placebo|Corn oil placebo, plus dietary counselling
10857780|NCT00346697|OG000|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
10857781|NCT00346697|OG001|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
10857782|NCT00346697|EG000|Reported Event|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
10857783|NCT00346697|EG001|Reported Event|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
10857784|NCT00346775|BG000|Baseline|Beconase + Nasarel|Participants were administered 168 µg Beconase AQ or 116 µg Nasarel metered dose nasal spray twice daily for 1 week in a sequence of Beconase /Nasarel or Nasarel/Beconase according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
10857785|NCT00346775|FG000|Participant Flow|Beconase Then Nasarel|Participants were administered 168 µg Beconase AQ metered dose nasal spray twice daily for 1 week. After a washout period of 7 days, participants were administered 116 µg Nasarel, metered dose nasal spray twice daily for 1 week.
10857786|NCT00346775|FG001|Participant Flow|Nasarel Then Beconase|Participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week. After a washout period of 7 days, participants were administered 168 µg Beconase AQ, metered dose nasal spray twice daily for 1 week.
10857787|NCT00346775|OG000|Outcome|Beconase + Nasarel|Participants were administered 168 µg Beconase AQ or 116 µg Nasarel metered dose nasal spray twice daily for 1 week in a sequence of Beconase /Nasarel or Nasarel/Beconase according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days. After completing TP2, at Visit 5 (Day 22), participants were administered the Preference Module of the EARNS-Q. The TSQM questionnaire was administered to participants at Visits 3 (Day 8) after completion of TP1 and on Visit 5 (Day 22), after completion of TP2. The validity of the Preference Module of the EARNS-Q was assessed by the correlation analysis with change scores (score of TP2 minus scores of TP1) of TSQM questionnaire and rTNSS. Because study medication was changed only once, there was only one assessment of the Preference Module of the EARNS-Q.
10878922|NCT00454649|OG000|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
10857788|NCT00346775|OG000|Outcome|Beconase + Nasarel|Participants were administered 168 µg Beconase AQ or 116 µg Nasarel metered dose nasal spray twice daily for 1 week in a sequence of Beconase /Nasarel or Nasarel/Beconase according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days. After completing TP2, at Visit 5 (Day 22), participants were administered the Preference Module of the EARNS-Q. The Experience Module of EARNS-Q questionnaire was administered on Visit 2 (Day 1) of each TP. The validity of the Preference Module of the EARNS-Q was assessed by the correlation analysis with change scores (score of TP2 minus scores of TP1) of the Experience Module of EARNS-Q questionnaire. Because study medication was changed only once, there was only one assessment of the Preference Module of the EARNS-Q.
10857789|NCT00346775|OG000|Outcome|Beconase|In each period of the study, participants were administered 168 µg Beconase AQ metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
10857790|NCT00346775|OG001|Outcome|Nasarel|In each period of the study, participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
10857791|NCT00346775|OG000|Outcome|Beconase|In each period of the study, participants were administered 168 μg Beconase AQ metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
10857792|NCT00346775|OG001|Outcome|Nasarel|In each period of the study, participants were administered 116 μg Nasarel metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
10857793|NCT00346775|EG000|Reported Event|Beconase|In each period of the study, participants were administered 168 µg Beconase AQ metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
10857794|NCT00346775|EG001|Reported Event|Nasarel|In each period of the study, participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
10857795|NCT00346905|BG000|Baseline|Group 1|Patients experiencing moderate GERD
10857796|NCT00346905|FG000|Participant Flow|Group 1|Patients that are GERD responsive and requiring daily PPI therapy
10857797|NCT00346905|OG000|Outcome|Enteryx Treatment|"Those receiving Enteryx treatment~Enteryx"
10857798|NCT00346905|EG000|Reported Event|Group 1 - Single Arm|Those experiencing GERD
10857799|NCT00347009|BG000|Baseline|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
10857800|NCT00347009|FG000|Participant Flow|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
10857801|NCT00347009|OG000|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
10857802|NCT00347009|EG000|Reported Event|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
10857803|NCT00347022|BG000|Baseline|Xenetix|Patient will be injected with Xenetix 300
10857804|NCT00347022|BG001|Baseline|Visipaque|Patient will be injected with Visipaque 270
10857805|NCT00347022|BG002|Baseline|Total|Total of all reporting groups
10857806|NCT00347022|FG000|Participant Flow|Xenetix|Patient will receive one injection of Xenetix 300
10857807|NCT00347022|FG001|Participant Flow|Visipaque|Patient will receive one injection of Visipaque 270
10857808|NCT00347022|OG000|Outcome|Xenetix|Patient will receive one injection of Xenetix 300
10857809|NCT00347022|OG001|Outcome|Visipaque|Patient will receive one injection of Visipaque 270
10857810|NCT00347022|EG000|Reported Event|Xenetix|Patient will be injected with Xenetix 300
10857811|NCT00347022|EG001|Reported Event|Vispaque|Patient will be injected with Visipaque 270
10857812|NCT00347269|BG000|Baseline|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
10857813|NCT00347269|BG001|Baseline|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
10857814|NCT00347269|BG002|Baseline|Total|Total of all reporting groups
10857815|NCT00347269|FG000|Participant Flow|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
10857816|NCT00347269|FG001|Participant Flow|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
10857817|NCT00347269|OG000|Outcome|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
10857818|NCT00347269|OG001|Outcome|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
10857819|NCT00347269|EG000|Reported Event|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
10857820|NCT00347269|EG001|Reported Event|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
10857821|NCT00347308|BG000|Baseline|Group 1|All patients entered into the study
10857822|NCT00347308|FG000|Participant Flow|Group 1|All patients entered into the study
10857823|NCT00347308|OG000|Outcome|Group 1|All patients entered into the study
10857824|NCT00347308|EG000|Reported Event|Group 1|All patients entered into the study
10857825|NCT00347360|BG000|Baseline|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
10857826|NCT00347360|BG001|Baseline|Lisinopril 20|lisinopril 20 mg once daily
10857827|NCT00347360|BG002|Baseline|Lisinopril 40|lisinopril 40 mg once daily
10857828|NCT00347360|BG003|Baseline|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
10857829|NCT00347360|BG004|Baseline|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
10857830|NCT00347360|BG005|Baseline|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
10857831|NCT00347360|BG006|Baseline|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
10857832|NCT00347360|BG007|Baseline|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
10857833|NCT00347360|BG008|Baseline|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
10857834|NCT00347360|BG009|Baseline|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
10857835|NCT00347360|BG010|Baseline|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
10857836|NCT00347360|BG011|Baseline|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
10857837|NCT00347360|BG012|Baseline|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
10857838|NCT00347360|BG013|Baseline|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
10857839|NCT00347360|BG014|Baseline|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
10857840|NCT00347360|BG015|Baseline|Total|Total of all reporting groups
10857841|NCT00347360|FG000|Participant Flow|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
10857842|NCT00347360|FG001|Participant Flow|Lisinopril 20|lisinopril 20 mg once daily
10857843|NCT00347360|FG002|Participant Flow|Lisinopril 40|lisinopril 40 mg once daily
10857844|NCT00347360|FG003|Participant Flow|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
10857845|NCT00347360|FG004|Participant Flow|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
10857846|NCT00347360|FG005|Participant Flow|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
10857847|NCT00347360|FG006|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
10857848|NCT00347360|FG007|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
10857849|NCT00347360|FG008|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
10857850|NCT00347360|FG009|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
10857851|NCT00347360|FG010|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
10857852|NCT00347360|FG011|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
10857853|NCT00347360|FG012|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
10857854|NCT00347360|FG013|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
10857855|NCT00347360|FG014|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
10857856|NCT00347360|OG000|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
10857857|NCT00347360|OG001|Outcome|Lisinopril 20|lisinopril 20 mg once daily
10857858|NCT00347360|OG002|Outcome|Lisinopril 40|lisinopril 40 mg once daily
10857859|NCT00347360|OG003|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
10857860|NCT00347360|OG004|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
10857861|NCT00347360|OG005|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
10857862|NCT00347360|OG006|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
10857863|NCT00347360|OG007|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
10857864|NCT00347360|OG008|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
10857865|NCT00347360|OG009|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
10857866|NCT00347360|OG010|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
10857867|NCT00347360|OG011|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
11347742|NCT04274075|FG002|Participant Flow|GDC-9545 Treatment Sequence C, A, and B|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence C, A, and B (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347743|NCT04274075|FG003|Participant Flow|GDC-9545 Treatment Sequence A, C, and B|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence A, C, and B (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347744|NCT04274075|FG004|Participant Flow|GDC-9545 Treatment Sequence B, A, and C|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence B, A, and C (please refer to the intervention descriptions). The washout period between doses was a minimum of 10 days.
11347745|NCT04274075|FG005|Participant Flow|GDC-9545 Treatment Sequence C, B, and A|Participants randomized to this arm received one dose of GDC-9545 at the start (Day 1) of each of three treatment periods according to the treatment cross-over sequence C, B, and A (please refer to the intervention descriptions). The washout period between doses will be a minimum of 10 days.
11347746|NCT04274075|OG000|Outcome|GDC-9545 Tablet, Fasted: Treatment A|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
11347747|NCT04274075|OG001|Outcome|GDC-9545 Capsule, Fasted: Treatment B|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
11347748|NCT04274075|OG002|Outcome|GDC-9545 Capsule, Fed: Treatment C|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment C. Treatment C consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal.
11347749|NCT04274075|OG000|Outcome|GDC-9545 Tablet, Fasted: Treatment A|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
11347750|NCT04274075|OG003|Outcome|Overall: Any GDC-9545 Treatment (A, B, or C)|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received at least one dose of any study drug (GDC-9545 Treatments A, B, or C).
11347751|NCT04274075|EG000|Reported Event|GDC-9545 Tablet, Fasted: Treatment A|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
11347752|NCT04274075|EG001|Reported Event|GDC-9545 Capsule, Fasted: Treatment B|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
11347753|NCT04274075|EG002|Reported Event|GDC-9545 Capsule, Fed: Treatment C|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment C. Treatment C consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal.
11347754|NCT04274075|EG003|Reported Event|Overall: Any GDC-9545 Treatment (A, B, or C)|This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received at least one dose of any study drug (GDC-9545 Treatments A, B, or C).
11347755|NCT04271605|BG000|Baseline|Intervention Group|"Patient enrollment Inclusion criteria~Age more than 50 years~Chronic kidney disease stage 3-4, and estimated glomerular filtration rate >20 mL/min/1.73m2~Fracture Risk Assessment Tool (FRAX®) screening: risk of hip fracture (HF) and major osteoporotic fracture (MOF) (HF: men>6%, women >7%; MOF: men>15%, women>12.5%).~Have ability to sign inform consent and agree with being follow-up for one year.~Exclusion criteria~Have cancer under treatment.~Have acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction, ST-elevation myocardial infarction) or stroke in 3 months. (ST segment is the flat, isoelectric section of the ECG between the end of the S wave and the beginning of the T wave.)~Limited cognitive or physical function for execute the intervention."
11347756|NCT04271605|FG000|Participant Flow|Behavior Intervention and Pharmacological Therapy|"Patient enrollment Inclusion criteria~Age more than 50 years~Chronic kidney disease stage 3-4, and estimated glomerular filtration rate >20 mL/min/1.73m2~Fracture Risk Assessment Tool (FRAX®) screening: risk of hip fracture (HF) and major osteoporotic fracture (MOF) (HF: men>6%, women >7%; MOF: men>15%, women>12.5%).~Have ability to sign inform consent and agree with being follow-up for one year."
10857868|NCT00347360|OG012|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
10857869|NCT00347360|OG013|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
11347757|NCT04271605|OG000|Outcome|Behavior Intervention and Pharmacological Therapy Group|"Patient enrollment Inclusion criteria~Age more than 50 years~Chronic kidney disease stage 3-4, and estimated glomerular filtration rate >20 mL/min/1.73m2~Fracture Risk Assessment Tool (FRAX)® screening: risk of hip fracture (HF) and major osteoporotic fracture (MOF) (HF: men>6%, women >7%; MOF: men>15%, women>12.5%).~Have ability to sign inform consent and agree with being follow-up for one year.~Behavior therapy and pharmacological therapy were given in each clinic visit after participants enrolled."
11347758|NCT04271605|EG000|Reported Event|Behavior Intervention and Pharmacological Therapy|"Patient enrollment Inclusion criteria~Age more than 50 years~Chronic kidney disease stage 3-4, and estimated glomerular filtration rate >20 mL/min/1.73m2~Fracture Risk Assessment Tool (FRAX)® screening: risk of hip fracture (HF) and major osteoporotic fracture (MOF) (HF: men>6%, women >7%; MOF: men>15%, women>12.5%).~Have ability to sign inform consent and agree with being follow-up for one year.~Behavior therapy and pharmacological therapy were given in each clinic visit after participants enrolled."
11347759|NCT04271761|BG000|Baseline|Current Adult Recipients of Cochlear Carina System|"Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.~Non-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject."
11347760|NCT04271761|FG000|Participant Flow|Current Adult Recipients of Cochlear Carina System|"Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.~Non-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject."
11347761|NCT04271761|OG000|Outcome|Current Adult Recipients of Cochlear Carina System|"Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.~Non-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject."
11347762|NCT04271761|EG000|Reported Event|Current Adult Recipients of Cochlear Carina System|"Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.~Non-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject."
11347763|NCT04268316|BG000|Baseline|Virtual Reality Behavioral Activation|Participants engage in VR activities over the week for three weeks.
11347764|NCT04268316|BG001|Baseline|Behavioral Activation in Real-life|Participants engage in real life pleasurable activities over the week for three weeks.
11347765|NCT04268316|BG002|Baseline|Waitlist Control|Participants answer the PHQ-9 weekly for four sessions.
11347766|NCT04268316|BG003|Baseline|Total|Total of all reporting groups
11347767|NCT04268316|FG000|Participant Flow|Virtual Reality Behavioral Activation|Participants engage in VR activities over the week for three weeks.
11347768|NCT04268316|FG001|Participant Flow|Behavioral Activation in Real-life|Participants engage in real life pleasurable activities over the week for three weeks.
11347769|NCT04268316|FG002|Participant Flow|Waitlist Control|Participants answer the PHQ-9 weekly for four sessions.
11347770|NCT04268316|OG000|Outcome|Virtual Reality Behavioral Activation|Participants engage in VR activities over the week for three weeks.
11347771|NCT04268316|OG001|Outcome|Behavioral Activation in Real-life|Participants engage in real life pleasurable activities over the week for three weeks.
11347772|NCT04268316|OG002|Outcome|Waitlist Control|Participants answer the PHQ-9 weekly for four sessions.
11347773|NCT04268316|EG000|Reported Event|Virtual Reality Behavioral Activation|Participants engage in VR activities over the week for three weeks.
11347774|NCT04268316|EG001|Reported Event|Behavioral Activation in Real-life|Participants engage in real life pleasurable activities over the week for three weeks.
11347775|NCT04268316|EG002|Reported Event|Waitlist Control|Participants answer the PHQ-9 weekly for four sessions.
11347776|NCT04269629|BG000|Baseline|Patients With a History of an Anaphylactic Sting Reaction|"At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings.~Insect Venom: Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs."
11347777|NCT04269629|FG000|Participant Flow|Patients With a History of an Anaphylactic Sting Reaction|"At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reactions and SR and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings.~Insect Venom: Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs."
10857870|NCT00347360|OG014|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
10857871|NCT00347360|EG000|Reported Event|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
10857872|NCT00347360|EG001|Reported Event|Lisinopril 20|lisinopril 20 mg once daily
10857873|NCT00347360|EG002|Reported Event|Lisinopril 40|lisinopril 40 mg once daily
10857874|NCT00347360|EG003|Reported Event|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
10857875|NCT00347360|EG004|Reported Event|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
10857876|NCT00347360|EG005|Reported Event|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
10857877|NCT00347360|EG006|Reported Event|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
10857878|NCT00347360|EG007|Reported Event|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
10857879|NCT00347360|EG008|Reported Event|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
10857880|NCT00347360|EG009|Reported Event|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
10857881|NCT00347360|EG010|Reported Event|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
10857882|NCT00347360|EG011|Reported Event|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
10857883|NCT00347360|EG012|Reported Event|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
10857884|NCT00347360|EG013|Reported Event|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
10857885|NCT00347360|EG014|Reported Event|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
10857886|NCT00347438|BG000|Baseline|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
10857887|NCT00347438|FG000|Participant Flow|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
10857888|NCT00347438|OG000|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
10857889|NCT00347438|EG000|Reported Event|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
10857890|NCT00347776|BG000|Baseline|Control|Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
10857891|NCT00347776|BG001|Baseline|Intervention1|Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
10857892|NCT00347776|BG002|Baseline|Intervention2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
10857893|NCT00347776|BG003|Baseline|Total|Total of all reporting groups
10857894|NCT00347776|FG000|Participant Flow|Control|Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
10857895|NCT00347776|FG001|Participant Flow|Intervention 1|Oral azithromycin,single 1g dose to subject only Antibiotic : Oral azithromycin (1 g)
10857896|NCT00347776|FG002|Participant Flow|Intervention 2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
10857897|NCT00347776|OG000|Outcome|Control|"Topical tetracycline~Antibiotic:Topical tetracycline"
10857898|NCT00347776|OG001|Outcome|Intervention|"The two azithromycin groups combined~Antibiotic: Oral Azithromycin"
10857899|NCT00347776|OG000|Outcome|Intervention1|Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
10857900|NCT00347776|OG001|Outcome|Intervention2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
10857901|NCT00347776|EG000|Reported Event|Control|"Topical tetracycline~Antibiotic:Topical tetracycline"
10857902|NCT00347776|EG001|Reported Event|Intervention|"The two azithromycin groups combined~Antibiotic: Oral Azithromycin"
10857903|NCT00347919|BG000|Baseline|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
10857904|NCT00347919|BG001|Baseline|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
10857905|NCT00347919|BG002|Baseline|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
10857906|NCT00347919|BG003|Baseline|Total|Total of all reporting groups
10857907|NCT00347919|FG000|Participant Flow|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
10857908|NCT00347919|FG001|Participant Flow|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
10857909|NCT00347919|FG002|Participant Flow|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
10857910|NCT00347919|OG000|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
10857911|NCT00347919|OG001|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
10857912|NCT00347919|OG002|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
10857913|NCT00347919|OG002|Outcome|Cohort 2: Lapatinib 1500 mg/ Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
10857914|NCT00347919|OG000|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
10857915|NCT00347919|EG000|Reported Event|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
10857916|NCT00347919|EG001|Reported Event|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
10857917|NCT00347919|EG002|Reported Event|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
10857918|NCT00347932|BG000|Baseline|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
10857919|NCT00347932|BG001|Baseline|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
10857920|NCT00347932|BG002|Baseline|Total|Total of all reporting groups
10857921|NCT00347932|FG000|Participant Flow|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
10857922|NCT00347932|FG001|Participant Flow|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
10857923|NCT00347932|OG000|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
11126353|NCT01732835|BG000|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
10857924|NCT00347932|OG001|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
10857925|NCT00347932|EG000|Reported Event|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
10857926|NCT00347932|EG001|Reported Event|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
10878923|NCT00454649|OG000|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
10878924|NCT00454649|OG001|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
10878925|NCT00454649|OG000|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
10878926|NCT00454649|OG000|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/meter square (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
10878927|NCT00454649|OG007|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 18 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
10878928|NCT00454649|EG000|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
10878929|NCT00454649|EG001|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878930|NCT00454649|EG002|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878931|NCT00454649|EG003|Reported Event|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
10878932|NCT00454649|EG004|Reported Event|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
10878933|NCT00454649|EG005|Reported Event|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
10878934|NCT00454649|EG006|Reported Event|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
10878935|NCT00454649|EG007|Reported Event|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
10857927|NCT00347958|BG000|Baseline|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
10857928|NCT00347958|FG000|Participant Flow|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
10857929|NCT00347958|OG000|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
10857930|NCT00347958|EG000|Reported Event|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
10857931|NCT00348140|BG000|Baseline|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
11126354|NCT01732835|FG000|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
10857932|NCT00348140|BG001|Baseline|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
10857933|NCT00348140|BG002|Baseline|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
10857934|NCT00348140|BG003|Baseline|Total|Total of all reporting groups
10857935|NCT00348140|FG000|Participant Flow|Placebo|Participants randomized to this arm received matching Rosiglitazone extended release (RSG XR) placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
10857936|NCT00348140|FG001|Participant Flow|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 milligrams (mg) once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
10857937|NCT00348140|FG002|Participant Flow|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
10857938|NCT00348140|OG000|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
10857939|NCT00348140|OG001|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
10857940|NCT00348140|OG002|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
10857941|NCT00348140|OG001|Outcome|RSG XR 2mg|Participants randomized to this arm received Rosiglitazone 2 mg in the form of extended release (XR) once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
10857942|NCT00348140|EG000|Reported Event|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
10857943|NCT00348140|EG001|Reported Event|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
10857944|NCT00348140|EG002|Reported Event|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
10857945|NCT00348205|BG000|Baseline|Technolas 217z Zyoptix System|"Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.~Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism."
10857946|NCT00348205|FG000|Participant Flow|Technolas 217z Zyoptix System|"Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.~Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism."
10857947|NCT00348205|OG000|Outcome|Technolas 217z Zyoptix System|"Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.~Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism."
10857948|NCT00348205|EG000|Reported Event|Technolas 217z Zyoptix System|"Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.~Technolas 217z Zyoptix Laser: Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism."
10857949|NCT00348283|BG000|Baseline|Placebo|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
10857950|NCT00348283|BG001|Baseline|Adalimumab 40 mg Every Other Week|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
10857951|NCT00348283|BG002|Baseline|Total|Total of all reporting groups
10857952|NCT00348283|FG000|Participant Flow|Placebo|SC dosing eow
10857953|NCT00348283|FG001|Participant Flow|Adalimumab|40 mg SC eow
10857954|NCT00348283|OG000|Outcome|Placebo|
10857955|NCT00348283|OG001|Outcome|Adalimumab|40 mg every other week
10857956|NCT00348283|EG000|Reported Event|Placebo|
10857957|NCT00348283|EG001|Reported Event|Adalimumab|All subjects (135 subjects) enrolled in the study received adalimumab 160 mg at Baseline followed by adalimumab 80 mg at Week 2 (Induction dose).
10857958|NCT00348309|BG000|Baseline|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
10857959|NCT00348309|BG001|Baseline|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
10857960|NCT00348309|BG002|Baseline|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
10857961|NCT00348309|BG003|Baseline|Total|Total of all reporting groups
10857962|NCT00348309|FG000|Participant Flow|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
10857963|NCT00348309|FG001|Participant Flow|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
10857964|NCT00348309|FG002|Participant Flow|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
10857965|NCT00348309|OG000|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
10857966|NCT00348309|OG001|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
10857967|NCT00348309|OG002|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
10857968|NCT00348309|OG001|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
10857969|NCT00348309|EG000|Reported Event|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
10857970|NCT00348309|EG001|Reported Event|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
10857971|NCT00348309|EG002|Reported Event|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
10857972|NCT00348348|BG000|Baseline|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
10857973|NCT00348348|BG001|Baseline|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
10857974|NCT00348348|BG002|Baseline|Total|Total of all reporting groups
10857975|NCT00348348|FG000|Participant Flow|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
10857976|NCT00348348|FG001|Participant Flow|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
10857977|NCT00348348|OG000|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
10857978|NCT00348348|OG001|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
10857979|NCT00348348|EG000|Reported Event|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
10857980|NCT00348348|EG001|Reported Event|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
10857981|NCT00348374|BG000|Baseline|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
10857982|NCT00348374|BG001|Baseline|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
10857983|NCT00348374|BG002|Baseline|Total|Total of all reporting groups
10857984|NCT00348374|FG000|Participant Flow|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
10878936|NCT00454649|EG008|Reported Event|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
10857985|NCT00348374|FG001|Participant Flow|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
10848860|NCT00292162|OG000|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
11126355|NCT01732835|OG000|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
10848861|NCT00292162|OG001|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
10848862|NCT00292162|EG000|Reported Event|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
10848863|NCT00292162|EG001|Reported Event|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
10848864|NCT00292188|BG000|Baseline|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
10848865|NCT00292188|BG001|Baseline|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
10848866|NCT00292188|BG002|Baseline|Total|Total of all reporting groups
10848867|NCT00292188|FG000|Participant Flow|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
10848868|NCT00292188|FG001|Participant Flow|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
10848869|NCT00292188|FG002|Participant Flow|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
10848870|NCT00292188|OG000|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
10848871|NCT00292188|OG001|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
10848872|NCT00292188|EG000|Reported Event|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
10848873|NCT00292188|EG001|Reported Event|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
10848874|NCT00292188|EG002|Reported Event|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
10848875|NCT00292227|BG000|Baseline|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
10848876|NCT00292227|BG001|Baseline|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
10848877|NCT00292227|BG002|Baseline|Total|Total of all reporting groups
10848878|NCT00292227|FG000|Participant Flow|Rotigotine Patch (Infusion: Placebo-Placebo)|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32 and on Day 39.
10848879|NCT00292227|FG001|Participant Flow|Placebo Patch (Infusion: Moxifloxacin-Placebo)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 32. Placebo saline solution 250 mL infused over 1 hour on Day 39.
10848880|NCT00292227|FG002|Participant Flow|Placebo Patch (Infusion: Placebo-Moxifloxacin)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 39.
10848881|NCT00292227|OG000|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
10848882|NCT00292227|OG001|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
10848883|NCT00292227|OG000|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
10848884|NCT00292227|OG001|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
10848885|NCT00292227|EG000|Reported Event|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
10848886|NCT00292227|EG001|Reported Event|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
10976856|NCT00942422|EG000|Reported Event|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
10976857|NCT00942448|BG000|Baseline|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976858|NCT00942448|BG001|Baseline|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976859|NCT00942448|BG002|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976860|NCT00942448|BG003|Baseline|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
10845655|NCT00268437|BG000|Baseline|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation>~> carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.>~> Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.>~> conventional surgery>~> neoadjuvant therapy>~> radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field)."
10848887|NCT00292318|BG000|Baseline|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
10976861|NCT00942448|BG004|Baseline|Total|Total of all reporting groups
10976862|NCT00942448|FG000|Participant Flow|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976863|NCT00942448|FG001|Participant Flow|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976864|NCT00942448|FG002|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976865|NCT00942448|FG003|Participant Flow|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
10976866|NCT00942448|OG000|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976867|NCT00942448|OG001|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976868|NCT00942448|OG002|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976869|NCT00942448|OG003|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
10976870|NCT00942448|OG000|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
10976871|NCT00942448|OG001|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
10976872|NCT00942448|OG002|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
10976873|NCT00942448|OG003|Outcome|Placebo s.c. 1ml|
10976874|NCT00942448|EG000|Reported Event|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976875|NCT00942448|EG001|Reported Event|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976876|NCT00942448|EG002|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
10976877|NCT00942448|EG003|Reported Event|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
11126356|NCT01732835|EG000|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
10976878|NCT00942578|BG000|Baseline|15 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976879|NCT00942578|BG001|Baseline|20 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976880|NCT00942578|BG002|Baseline|25 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976881|NCT00942578|BG003|Baseline|Total|Total of all reporting groups
10857986|NCT00348374|OG000|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
10857987|NCT00348374|OG001|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
10857988|NCT00348374|OG000|Outcome|Exubera®|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
10857989|NCT00348374|EG000|Reported Event|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
10857990|NCT00348374|EG001|Reported Event|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
10857991|NCT00348595|BG000|Baseline|Revlimid 5mg/Day|One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.
10857992|NCT00348595|BG001|Baseline|Revlimid 25mg/Day|One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.
10857993|NCT00348595|BG002|Baseline|Total|Total of all reporting groups
10857994|NCT00348595|FG000|Participant Flow|Revlimid 5mg/Day|One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
10857995|NCT00348595|FG001|Participant Flow|Revlimid 25mg/Day|One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
10857996|NCT00348595|OG000|Outcome|Revlimid 5mg/Day|One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
10857997|NCT00348595|OG001|Outcome|Revlimid 25mg/Day|One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
10857998|NCT00348595|EG000|Reported Event|Revlimid 5mg/Day|One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.
10857999|NCT00348595|EG001|Reported Event|Revlimid 25mg/Day|One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.
10858000|NCT00348673|BG000|Baseline|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858001|NCT00348673|BG001|Baseline|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858002|NCT00348673|BG002|Baseline|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858003|NCT00348673|BG003|Baseline|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
10858004|NCT00348673|BG004|Baseline|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
10858005|NCT00348673|BG005|Baseline|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
10858006|NCT00348673|BG006|Baseline|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
10858007|NCT00348673|BG007|Baseline|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
10858008|NCT00348673|BG008|Baseline|Total|Total of all reporting groups
10858009|NCT00348673|FG000|Participant Flow|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858010|NCT00348673|FG001|Participant Flow|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858011|NCT00348673|FG002|Participant Flow|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858012|NCT00348673|FG003|Participant Flow|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
10976882|NCT00942578|FG000|Participant Flow|15 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21~Docetaxel: 75 mg/m2 IV over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976883|NCT00942578|FG001|Participant Flow|20 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21~Docetaxel: 75 mg/m2 IV over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976884|NCT00942578|FG002|Participant Flow|25 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21~Docetaxel: 75 mg/m2 IV over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10858013|NCT00348673|FG004|Participant Flow|Placebo Once/Twice Daily (Stage 1)|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858014|NCT00348673|FG005|Participant Flow|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
10858015|NCT00348673|FG006|Participant Flow|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
10858016|NCT00348673|FG007|Participant Flow|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
10858017|NCT00348673|FG008|Participant Flow|Placebo Once/Twice Daily (Stage 2)|Three placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
10858018|NCT00348673|OG000|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858019|NCT00348673|OG001|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858020|NCT00348673|OG002|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858021|NCT00348673|OG003|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
10858022|NCT00348673|OG004|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
10858023|NCT00348673|OG005|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
10858024|NCT00348673|OG006|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
10858025|NCT00348673|OG007|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
10858026|NCT00348673|EG000|Reported Event|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858027|NCT00348673|EG001|Reported Event|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858028|NCT00348673|EG002|Reported Event|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
10858029|NCT00348673|EG003|Reported Event|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
10858030|NCT00348673|EG004|Reported Event|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
10858031|NCT00348673|EG005|Reported Event|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
10858032|NCT00348673|EG006|Reported Event|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
10858033|NCT00348673|EG007|Reported Event|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
10858034|NCT00348686|BG000|Baseline|Candesartan|
10858035|NCT00348686|FG000|Participant Flow|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
10858036|NCT00348686|OG000|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
10858037|NCT00348686|EG000|Reported Event|Candesartan|
10858038|NCT00348790|BG000|Baseline|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
10858039|NCT00348790|FG000|Participant Flow|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
10858040|NCT00348790|OG000|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
10858041|NCT00348790|OG000|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months.~vatalanib"
10858042|NCT00348790|EG000|Reported Event|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months.~vatalanib"
10858043|NCT00348816|BG000|Baseline|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
10858044|NCT00348816|FG000|Participant Flow|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
10858045|NCT00348816|OG000|Outcome|Docetaxel (Single Arm)|Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
10858046|NCT00348816|OG000|Outcome|Overall Survival|N/A, no data for overall survival recorded
10858047|NCT00348816|OG000|Outcome|Correlation Between Velocity of Subsequent PSA Failure and Sur|All study completers
10858048|NCT00348816|EG000|Reported Event|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
10858049|NCT00348881|BG000|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
10858050|NCT00348881|BG001|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
10858051|NCT00348881|BG002|Baseline|Total|Total of all reporting groups
10858052|NCT00348881|FG000|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
10858053|NCT00348881|FG001|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
10858054|NCT00348881|OG000|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
10858055|NCT00348881|OG001|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
10858056|NCT00348881|OG000|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
10858057|NCT00348881|OG001|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/Hib™ Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
10858058|NCT00348881|OG000|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
10858059|NCT00348881|OG001|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
10858060|NCT00348881|EG000|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
10858061|NCT00348881|EG001|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
10858062|NCT00348933|BG000|Baseline|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
10858063|NCT00348933|FG000|Participant Flow|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
10858064|NCT00348933|OG000|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
10858065|NCT00348933|OG000|Outcome|Treatment (Metafolin/Creatine/Betain/B12)|All participants received treatment. Compared to a placebo group from a previous study.
10858066|NCT00348933|EG000|Reported Event|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
10858067|NCT00348946|BG000|Baseline|Oxandrolone|androgen oxandrolone: Oxandrolone ,0.6 >mg/kg/day, orally, for 2 years.
10858068|NCT00348946|BG001|Baseline|Placebo|placebo: an inactive substance
10858069|NCT00348946|BG002|Baseline|Total|Total of all reporting groups
10858070|NCT00348946|FG000|Participant Flow|Oxandrolone|androgen oxandrolone: Oxandrolone ,0.6 >mg/kg/day, orally, for 2 years.
10858071|NCT00348946|FG001|Participant Flow|Placebo|placebo: an inactive substance
10858072|NCT00348946|OG000|Outcome|Oxandrolone|androgen oxandrolone: Oxandrolone ,06 >mg/kg/day, orally, for 2 years
10858073|NCT00348946|OG001|Outcome|Placebo|placebo: an inactive substance
10858074|NCT00348946|OG000|Outcome|Oxandrolone|"Androgen oxandrolone: Oxandrolone, 0.6 > mg/kg/day, orally, for 2 years.~androgen oxandrolone: Oxandrolone ,06 >mg/kg/day, orally, for 2 years"
10858075|NCT00348946|OG001|Outcome|Placebo|"An inactive substance.~placebo: an inactive substance"
10858076|NCT00348946|EG000|Reported Event|Oxandrolone|androgen oxandrolone: Oxandrolone ,0.6 >mg/kg/day, orally, for 2 years
10858077|NCT00348946|EG001|Reported Event|Placebo|placebo: an inactive substance
10858078|NCT00349336|BG000|Baseline|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
10858079|NCT00349336|BG001|Baseline|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
10858080|NCT00349336|BG002|Baseline|Total|Total of all reporting groups
10858081|NCT00349336|FG000|Participant Flow|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
10858082|NCT00349336|FG001|Participant Flow|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
10858083|NCT00349336|OG000|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
10858084|NCT00349336|OG001|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
10858085|NCT00349336|EG000|Reported Event|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
10858086|NCT00349336|EG001|Reported Event|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
10858087|NCT00349349|BG000|Baseline|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
10858088|NCT00349349|BG001|Baseline|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
10858089|NCT00349349|BG002|Baseline|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
10858090|NCT00349349|BG003|Baseline|Total|Total of all reporting groups
10858091|NCT00349349|FG000|Participant Flow|2000 mg Ofatumumab + DR|Ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The independent endpoint review committee (IRC) classified these participants as double refractory (DR), defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
10858092|NCT00349349|FG001|Participant Flow|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
10858093|NCT00349349|FG002|Participant Flow|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
10858094|NCT00349349|OG000|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
11347778|NCT04269629|OG000|Outcome|Patients Who Underwent VIT Updosing|"Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reactions and SR and changes in diseases and medication will be recorded.~The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs."
11347779|NCT04269629|OG000|Outcome|Patients With a History of an Anaphylactic Sting Reaction|At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. The severity of the systemic sting reaction is compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.
11347780|NCT04269629|OG000|Outcome|Patients With Anaphylactic Sting Reaction|At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication.
11347781|NCT04269629|OG000|Outcome|Patients Who Underwent VIT Updosing|"Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded.~The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs."
11347782|NCT04269629|OG000|Outcome|Patients Who Underwent VIT for at Least 1 Year|"One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings.~The outcome (systemic reaction or not) of insect stings is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs."
11347783|NCT04269629|EG000|Reported Event|Patients With a History of an Anaphylactic Sting Reaction|"At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings.~Insect Venom: Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs."
11347784|NCT04267575|BG000|Baseline|Primary Arm|"After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.~Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.~Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team."
11347785|NCT04267575|FG000|Participant Flow|Primary Arm|"After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.~Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.~Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team."
11347786|NCT04267575|OG000|Outcome|Primary Arm|"After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.~Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.~Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team."
11347787|NCT04267575|EG000|Reported Event|Primary Arm|"Patients received previous chemotherapy, radiation, immuno-therapy and/or surgery prior to metastatic recurrent disease. In this study, the patients gross solid tumor was removed, and cold plasma was sprayed in the area of the resected tumor margins.~Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.~Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team."
11347788|NCT04267770|BG000|Baseline|Circadian Insulin Infusion Rates|"Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years.~Insulin (circadian): Participant's own insulin adjusted to circadian infusion rates"
11347789|NCT04267770|BG001|Baseline|Flat Rates|"flat basal rate~Insulin (flat rate): Participant's own insulin set to flat basal rates"
11347790|NCT04267770|BG002|Baseline|Total|Total of all reporting groups
11347791|NCT04267770|FG000|Participant Flow|Circadian Insulin Infusion Rates|"Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years.~Insulin (circadian): Participant's own insulin adjusted to circadian infusion rates"
11347792|NCT04267770|FG001|Participant Flow|Flat Rates|"flat basal rate~Insulin (flat rate): Participant's own insulin set to flat basal rates"
11347793|NCT04267770|OG000|Outcome|Circadian Insulin Infusion Rates|"Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years.~Insulin (circadian): Participant's own insulin adjusted to circadian infusion rates"
11347794|NCT04267770|OG001|Outcome|Flat Rates|"flat basal rate~Insulin (flat rate): Participant's own insulin set to flat basal rates"
11347795|NCT04267770|EG000|Reported Event|Circadian Insulin Infusion Rates|"Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years.~Insulin (circadian): Participant's own insulin adjusted to circadian infusion rates"
11347796|NCT04267770|EG001|Reported Event|Flat Rates|"flat basal rate~Insulin (flat rate): Participant's own insulin set to flat basal rates"
10858095|NCT00349349|OG001|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
10858096|NCT00349349|OG002|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
10858097|NCT00349349|OG000|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
10858098|NCT00349349|OG000|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined
10858099|NCT00349349|EG000|Reported Event|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
10858100|NCT00349349|EG001|Reported Event|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
10858101|NCT00349349|EG002|Reported Event|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
10858102|NCT00349388|BG000|Baseline|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
10858103|NCT00349388|BG001|Baseline|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
10858104|NCT00349388|BG002|Baseline|Total|Total of all reporting groups
10858105|NCT00349388|FG000|Participant Flow|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
10858106|NCT00349388|FG001|Participant Flow|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
10858107|NCT00349388|OG000|Outcome|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
10858108|NCT00349388|OG001|Outcome|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
10858109|NCT00349388|EG000|Reported Event|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
10858110|NCT00349388|EG001|Reported Event|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
10858111|NCT00349622|BG000|Baseline|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
10858112|NCT00349622|BG001|Baseline|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
10858113|NCT00349622|BG002|Baseline|Total|Total of all reporting groups
10858114|NCT00349622|FG000|Participant Flow|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
10858115|NCT00349622|FG001|Participant Flow|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
10858116|NCT00349622|OG000|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
10858117|NCT00349622|OG001|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
10858118|NCT00349622|EG000|Reported Event|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
10858119|NCT00349622|EG001|Reported Event|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
10858120|NCT00349713|BG000|Baseline|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
10858121|NCT00349713|BG001|Baseline|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
10858122|NCT00349713|BG002|Baseline|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
10858123|NCT00349713|BG003|Baseline|Total|Total of all reporting groups
10858124|NCT00349713|FG000|Participant Flow|Cohort 1: FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
10858125|NCT00349713|FG001|Participant Flow|Cohort 2: FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
10858126|NCT00349713|FG002|Participant Flow|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
10858127|NCT00349713|OG000|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
10858128|NCT00349713|OG001|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
10858129|NCT00349713|OG002|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
10858130|NCT00349713|EG000|Reported Event|Cohort 1: 25 ug FMP2.1 / AS02|25 ug FMPs.1 / AS02
10858131|NCT00349713|EG001|Reported Event|Cohort 2: 50 ug FMP2.1 / AS02A|50 ug FMP2.1 / AS02A
10858132|NCT00349713|EG002|Reported Event|Cohort 3: Rabies Vaccine (RabAvert)|Rabies vaccine, All events reports instead of AE's per vaccination group 20 subjects (10 from Cohort 1 and 10 from Cohort 2)
10858133|NCT00349752|BG000|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
10858134|NCT00349752|BG001|Baseline|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
10858135|NCT00349752|BG002|Baseline|Total|Total of all reporting groups
10858136|NCT00349752|FG000|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
10858137|NCT00349752|FG001|Participant Flow|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
10858138|NCT00349752|OG000|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
10858139|NCT00349752|OG001|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
10858140|NCT00349752|EG000|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
10858141|NCT00349752|EG001|Reported Event|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
10858142|NCT00349778|BG000|Baseline|High-Dose Sequential Therapy|Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
10858143|NCT00349778|FG000|Participant Flow|High-Dose Sequential Therapy|Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
10858144|NCT00349778|OG000|Outcome|High-Dose Sequential Therapy|Cyclophosphamide + etoposide + melphalan + carmustine with filgrastim
10858145|NCT00349778|EG000|Reported Event|High-Dose Sequential Therapy|Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
10858146|NCT00349908|BG000|Baseline|Aneurysm Arm|Intracranial wide-necked aneurysms
10858147|NCT00349908|BG001|Baseline|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
10858148|NCT00349908|BG002|Baseline|Total|Total of all reporting groups
10858149|NCT00349908|FG000|Participant Flow|Aneurysm Arm|Intracranial wide-necked aneurysms
10858150|NCT00349908|FG001|Participant Flow|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
10858151|NCT00349908|OG000|Outcome|Group 1|Atherosclerosis Arm
10858152|NCT00349908|OG001|Outcome|Group 2|Aneurysm Arm
10858153|NCT00349908|OG000|Outcome|Group 1|Atherosclerosis
10858154|NCT00349908|EG000|Reported Event|Group 1: Atherosclerosis Arm|This is the events from the Atherosclerosis Arm
10858155|NCT00349908|EG001|Reported Event|Group 2: Aneurysm Arm|This is the events from the Aneurysm Arm
10858156|NCT00349921|BG000|Baseline|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
10858157|NCT00349921|BG001|Baseline|Adenosine Given First, Then Clonidine|adenosine given in first injection clonidine given in second injection
10858158|NCT00349921|BG002|Baseline|Clonidine Given First, Then Placebo|clonidine given first placebo given in second injection
10858159|NCT00349921|BG003|Baseline|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
10858160|NCT00349921|BG004|Baseline|Total|Total of all reporting groups
10858161|NCT00349921|FG000|Participant Flow|Clonidine First, Then Adenosine|Clonidine given during the first period and adenosine given during the second period
10858162|NCT00349921|FG001|Participant Flow|Adenosine First, Then Clonidine|Adenosine given during the first period and adenosine given during the second
10858163|NCT00349921|FG002|Participant Flow|Clonidine First, Then Placebo|Clonidine given as during the first period, then placebo during the second
10858164|NCT00349921|FG003|Participant Flow|Adenosine First, Then Placebo|Adenosine given during the first period and placebo given during the second
10858165|NCT00349921|OG000|Outcome|Clonidine|clonidine received as either first or second injection
10858166|NCT00349921|OG001|Outcome|Adenosine|Adenosine received as either first or second injection
10858167|NCT00349921|OG002|Outcome|Placebo|Placebo received as either first or second injection
11347797|NCT04266925|BG000|Baseline|3 Referees|"Three referees were present on the field during these youth soccer matches.~3 referees present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks."
11347798|NCT04266925|BG001|Baseline|1 Referee|"One referee was present on the field during these youth soccer matches.~1 referee present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks."
11347799|NCT04266925|BG002|Baseline|Total|Total of all reporting groups
11347800|NCT04266925|FG000|Participant Flow|3 Referees First|"Three referees were present on the field first during these youth soccer matches.~3 referees present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks."
11347801|NCT04266925|FG001|Participant Flow|1 Referee|"One referee was present on the field first during these youth soccer matches.~1 referee present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks."
11347802|NCT04266925|OG000|Outcome|3 Referees|"Three referees were present on the field during these youth soccer matches.~3 referees present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks."
11347803|NCT04266925|OG001|Outcome|1 Referee|"One referee was present on the field during these youth soccer matches.~1 referee present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks."
11347804|NCT04266925|EG000|Reported Event|3 Referees|"Three referees were present on the field during these youth soccer matches.~3 referees present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks."
11347805|NCT04266925|EG001|Reported Event|1 Referee|"One referee was present on the field during these youth soccer matches.~1 referee present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks."
11347806|NCT04263142|BG000|Baseline|Part 1: Treatment Sequence AB|Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
11347807|NCT04263142|BG001|Baseline|Part 1: Treatment Sequence BA|Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
11347808|NCT04263142|BG002|Baseline|Part 2: Treatment Sequence CDE|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
11347809|NCT04263142|BG003|Baseline|Part 2: Treatment Sequence DEC|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
11347810|NCT04263142|BG004|Baseline|Part 2: Treatment Sequence ECD|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
11347811|NCT04263142|BG005|Baseline|Total|Total of all reporting groups
11347812|NCT04263142|FG000|Participant Flow|Part 1: Treatment Sequence AB|Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
11347813|NCT04263142|FG001|Participant Flow|Part 1: Treatment Sequence BA|Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
11347814|NCT04263142|FG002|Participant Flow|Part 2: Treatment Sequence CDE|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
11347815|NCT04263142|FG003|Participant Flow|Part 2: Treatment Sequence DEC|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
11347816|NCT04263142|FG004|Participant Flow|Part 2: Treatment Sequence ECD|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
11347817|NCT04263142|OG000|Outcome|Part 1: GSK3640254 200 mg Capsules|Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
11347818|NCT04263142|OG001|Outcome|Part 1: GSK3640254 200 mg Tablets|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
11347819|NCT04263142|OG000|Outcome|Part 2: GSK3640254 200 mg Tablet (Moderate Fat)|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3.
11347820|NCT04263142|OG001|Outcome|Part 2: GSK3640254 200 mg Tablet (Fasted)|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3.
11347821|NCT04263142|OG002|Outcome|Part 2: GSK3640254 200 mg Tablet (High Fat)|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
11347822|NCT04263142|OG001|Outcome|Part 2: GSK3640254 200 mg Tablet (Fasted)|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1 or 2.
11347823|NCT04263142|EG000|Reported Event|Part 1: GSK3640254 200 mg Capsules|Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
11347824|NCT04263142|EG001|Reported Event|Part 1: GSK3640254 200 mg Tablets|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
11347825|NCT04263142|EG002|Reported Event|Part 2: GSK3640254 200 mg Tablet (Moderate Fat)|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3.
11347826|NCT04263142|EG003|Reported Event|Part 2: GSK3640254 200 mg Tablet (Fasted)|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3.
11347827|NCT04263142|EG004|Reported Event|Part 2: GSK3640254 200 mg Tablet (High Fat)|Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
11347828|NCT04256785|BG000|Baseline|VSL#3|"probiotic VSL#3, 2 sachets b.i.d for 3 months~VSL#3: sachets containing probiotic"
11347829|NCT04256785|BG001|Baseline|Placebo|"matched placebo, 2 sachets b.i.d for 3 months~Placebo: sachets containing placebo"
11347830|NCT04256785|BG002|Baseline|Total|Total of all reporting groups
11347831|NCT04256785|FG000|Participant Flow|VSL#3|"probiotic VSL#3, 2 sachets b.i.d for 3 months~VSL#3: sachets containing probiotic"
11347832|NCT04256785|FG001|Participant Flow|Placebo|"matched placebo, 2 sachets b.i.d for 3 months~Placebo: sachets containing placebo"
11347833|NCT04256785|OG000|Outcome|VSL#3|"probiotic VSL#3, 2 sachets b.i.d for 3 months~VSL#3: sachets containing probiotic~54 subjects"
11347834|NCT04256785|OG001|Outcome|Placebo|"matched placebo, 2 sachets b.i.d for 3 months~Placebo: sachets containing placebo~56 subjects"
11347835|NCT04256785|OG000|Outcome|VSL#3|"probiotic VSL#3, 2 sachets b.i.d for 3 months~VSL#3: sachets containing probiotic"
11347836|NCT04256785|OG001|Outcome|Placebo|"matched placebo, 2 sachets b.i.d for 3 months~Placebo: sachets containing placebo"
11347837|NCT04256785|EG000|Reported Event|VSL#3|"probiotic VSL#3, 2 sachets b.i.d for 3 months~VSL#3: sachets containing probiotic"
11347838|NCT04256785|EG001|Reported Event|Placebo|"matched placebo, 2 sachets b.i.d for 3 months~Placebo: sachets containing placebo"
11347839|NCT04252092|BG000|Baseline|Sensory Group|"15 patients who will be applied 15 sessions of sensory training~Sensory training: 15 session,20 minutes sensory training program"
11347840|NCT04252092|BG001|Baseline|Electrical Stimulation Group|"15 patients who will be applied 15 sessions of electrical stimulation~Electrical stimulation: 15 session,20 minutes electrical stimulation program"
11347841|NCT04252092|BG002|Baseline|Total|Total of all reporting groups
11347842|NCT04252092|FG000|Participant Flow|Sensory Group|"15 patients who will be applied 15 sessions of sensory training~Sensory training: 15 session,20 minutes sensory training program"
11347843|NCT04252092|FG001|Participant Flow|Electrical Stimulation Group|"15 patients who will be applied 15 sessions of electrical stimulation~Electrical stimulation: 15 session,20 minutes electrical stimulation program"
11347844|NCT04252092|OG000|Outcome|Sensory Group|"15 patients who will be applied 15 sessions of sensory training~Sensory training: 15 session,20 minutes sensory training program"
11347845|NCT04252092|OG001|Outcome|Electrical Stimulation Group|"15 patients who will be applied 15 sessions of electrical stimulation~Electrical stimulation: 15 session,20 minutes electrical stimulation program"
11347846|NCT04252092|EG000|Reported Event|Sensory Group|"15 patients who will be applied 15 sessions of sensory training~Sensory training: 15 session,20 minutes sensory training program"
11347847|NCT04252092|EG001|Reported Event|Electrical Stimulation Group|"15 patients who will be applied 15 sessions of electrical stimulation~Electrical stimulation: 15 session,20 minutes electrical stimulation program"
11347848|NCT04250987|BG000|Baseline|Participants Undergoing Catheterization With SpeediCath ®|One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
11347849|NCT04250987|FG000|Participant Flow|Participants Undergoing Catheterization With SpeediCath ®|One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
11347850|NCT04250987|OG000|Outcome|Participants Undergoing Catheterization With SpeediCath ®|One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
11347851|NCT04250987|EG000|Reported Event|Participants Undergoing Catheterization With SpeediCath ®|One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
10858168|NCT00349921|EG000|Reported Event|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
10858169|NCT00349921|EG001|Reported Event|Adenosine First, Then Clonidine|adenosine given in first injection clonidine given in second injection
10858170|NCT00349921|EG002|Reported Event|Clonidine First, Then Placebo|clonidine given first placebo given in second injection
10858171|NCT00349921|EG003|Reported Event|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
10858172|NCT00349973|BG000|Baseline|Dipyridamole|"Dipyridamole~Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm"
10858173|NCT00349973|BG001|Baseline|Olanzapine|"Olanzapine~Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm"
10858174|NCT00349973|BG002|Baseline|Total|Total of all reporting groups
10858175|NCT00349973|FG000|Participant Flow|Dipyridamole|"Dipyridamole~Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm"
10858176|NCT00349973|FG001|Participant Flow|Olanzapine|"Olanzapine~Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm"
10858177|NCT00349973|OG000|Outcome|Dipyridamole|"Dipyridamole~Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm"
10858178|NCT00349973|OG001|Outcome|Olanzapine|"Olanzapine~Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm"
10858179|NCT00349973|EG000|Reported Event|Dipyridamole|"Dipyridamole~Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm"
10858180|NCT00349973|EG001|Reported Event|Olanzapine|"Olanzapine~Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm"
10858181|NCT00350025|BG000|Baseline|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
10858182|NCT00350025|BG001|Baseline|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
10858183|NCT00350025|BG002|Baseline|Total|Total of all reporting groups
10858184|NCT00350025|FG000|Participant Flow|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
10858185|NCT00350025|FG001|Participant Flow|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
10858186|NCT00350025|OG000|Outcome|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
10858187|NCT00350025|OG001|Outcome|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
10858188|NCT00350025|EG000|Reported Event|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
10858189|NCT00350025|EG001|Reported Event|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
10858190|NCT00350142|BG000|Baseline|SBRT|25 Gy single fraction dose using Trilogy linear accelerator
10858191|NCT00350142|FG000|Participant Flow|Stereotactic Body Radiotherapy|"patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes.~Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months."
10858192|NCT00350142|OG000|Outcome|Stereotactic Radiosurgery|patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine
10858193|NCT00350142|OG000|Outcome|Stereotactic Body Radiotherapy|"single fraction 25 Gy dose Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine~Stereotactic Body Radiotherapy: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator~Gemcitabine: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes"
10858194|NCT00350142|EG000|Reported Event|SBRT With Gem|patient with locally advanced pancreas cancer receiving Gem + SBRT
10858195|NCT00350207|BG000|Baseline|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
10858196|NCT00350207|BG001|Baseline|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
10858197|NCT00350207|BG002|Baseline|Placebo|Matching Placebo
10858198|NCT00350207|BG003|Baseline|Total|Total of all reporting groups
10858199|NCT00350207|FG000|Participant Flow|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
10858200|NCT00350207|FG001|Participant Flow|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
10858201|NCT00350207|FG002|Participant Flow|Placebo|Matching Placebo
10858202|NCT00350207|OG000|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
10858203|NCT00350207|OG001|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
10858204|NCT00350207|OG002|Outcome|Placebo|Matching Placebo
10858205|NCT00350207|EG000|Reported Event|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
10858206|NCT00350207|EG001|Reported Event|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
10858207|NCT00350207|EG002|Reported Event|Placebo|Matching Placebo
10858208|NCT00350220|BG000|Baseline|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
10858209|NCT00350220|BG001|Baseline|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
10858210|NCT00350220|BG002|Baseline|Total|Total of all reporting groups
10858211|NCT00350220|FG000|Participant Flow|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
10858212|NCT00350220|FG001|Participant Flow|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
10858213|NCT00350220|OG000|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
10858214|NCT00350220|OG001|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
10858215|NCT00350220|EG000|Reported Event|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
10858216|NCT00350220|EG001|Reported Event|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
10858217|NCT00350272|BG000|Baseline|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858218|NCT00350272|BG001|Baseline|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858219|NCT00350272|BG002|Baseline|Total|Total of all reporting groups
10858220|NCT00350272|FG000|Participant Flow|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858221|NCT00350272|FG001|Participant Flow|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858222|NCT00350272|OG000|Outcome|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858223|NCT00350272|OG001|Outcome|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858224|NCT00350272|OG000|Outcome|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858225|NCT00350272|OG001|Outcome|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858226|NCT00350272|EG000|Reported Event|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858227|NCT00350272|EG001|Reported Event|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
10858228|NCT00350298|BG000|Baseline|GS-CDA1/MDX-1388|Biological: GS-CDA1/MDX-1388 One Intravenous dose
10858229|NCT00350298|BG001|Baseline|Placebo|Biological: normal saline (0.9% sodium chloride) One Intravenous dose
10858230|NCT00350298|BG002|Baseline|Total|Total of all reporting groups
10858231|NCT00350298|FG000|Participant Flow|GS-CDA1/MDX-1388|Biological: GS-CDA1/MDX-1388 One Intravenous dose
10858232|NCT00350298|FG001|Participant Flow|Placebo|Biological: normal saline (0.9% sodium chloride) One Intravenous dose
10858233|NCT00350298|OG000|Outcome|GS-CDA1/MDX-1388|Biological: GS-CDA1/MDX-1388 One Intravenous dose
10858234|NCT00350298|OG001|Outcome|Placebo|Biological: normal saline (0.9% sodium chloride) One Intravenous dose
10858235|NCT00350298|EG000|Reported Event|GS-CDA1/MDX-1388|Biological: GS-CDA1/MDX-1388 One Intravenous dose
10858236|NCT00350298|EG001|Reported Event|Placebo|Biological: normal saline (0.9% sodium chloride) One Intravenous dose
10858237|NCT00350337|BG000|Baseline|Pre-transfection F17|"4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.~Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine.~Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection."
10858238|NCT00350337|BG001|Baseline|Post-transfection F17|"DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262.~Lyophilized, single dose vials and sterile water for injection.~Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose."
10878937|NCT00454649|EG009|Reported Event|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
10878938|NCT00454779|BG000|Baseline|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
10878939|NCT00454779|BG001|Baseline|Chemotherapy Alone|Docetaxel + Cisplatin, control
10878940|NCT00454779|BG002|Baseline|Total|Total of all reporting groups
10878941|NCT00454779|FG000|Participant Flow|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
10878942|NCT00454779|FG001|Participant Flow|Chemotherapy Alone|Docetaxel + Cisplatin, control
10878943|NCT00454779|OG000|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
10878944|NCT00454779|OG001|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
10878945|NCT00454779|EG000|Reported Event|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
10878946|NCT00454779|EG001|Reported Event|Chemotherapy Alone|Docetaxel + Cisplatin, control
10878947|NCT00454805|BG000|Baseline|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
10976885|NCT00942578|OG000|Outcome|Single Arm - 4 Drug Combination|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21~Docetaxel: 75 mg/m2 IV over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976886|NCT00942578|OG000|Outcome|Single Arm - 4 Drug Combination|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21~Docetaxel: 75 mg/m^2 intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976887|NCT00942578|OG000|Outcome|15 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976888|NCT00942578|OG001|Outcome|20 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976889|NCT00942578|OG002|Outcome|25 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976890|NCT00942578|OG000|Outcome|15 mg Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976891|NCT00942578|OG001|Outcome|20 mg Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976892|NCT00942578|OG002|Outcome|25 mg Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976893|NCT00942578|EG000|Reported Event|15 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976894|NCT00942578|EG001|Reported Event|20 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976895|NCT00942578|EG002|Reported Event|25 mg Dose Lenalidomide|"A two dose level escalation of Lenalidomide from 15mg to 20mg to 25mg- standard 3+3 dose escalation approach in combination with docetaxel, Bevacizumab and prednisone.~Bevacizumab: 15 mg/kg cycle 1 day 1, repeated every 21 days~Lenalidomide: Once daily days 1-14 of every 21 days~Docetaxel: 75 mg/m(2) intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)~Prednisone: 10 mg orally every day"
10976896|NCT00942604|BG000|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10976897|NCT00942604|BG001|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
10976898|NCT00942604|BG002|Baseline|Total|Total of all reporting groups
11347852|NCT04249336|BG000|Baseline|BioMin F Dentifrices|"Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.~Fluoro-Calcium-Phospho-Silicate based dentifrices: Bio-Active glass based formulation"
10976899|NCT00942604|FG000|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10976900|NCT00942604|FG001|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
10976901|NCT00942604|OG000|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10976902|NCT00942604|OG001|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
11347853|NCT04249336|BG001|Baseline|Colgate Sensitive Pro Relief Trademark Dentifrices|"Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.~8% Arginine based dentifrices: Tubular occluding formulation"
11347854|NCT04249336|BG002|Baseline|Sensodyne Rapid Action Trademark Dentifrices|"Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.~8% Strontium Acetate: Tubular occluding formulation"
11347855|NCT04249336|BG003|Baseline|Colgate Total Trademark|"Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.~Sodium Fluoride: No claim of relieving Dentin Hypersensitivity"
11347856|NCT04249336|BG004|Baseline|Total|Total of all reporting groups
11347857|NCT04249336|FG000|Participant Flow|Colgate Sensitive Pro Relief|"Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.~Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation"
11347858|NCT04249336|FG001|Participant Flow|BioMin F|"Participants received BioMin F Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.~BioMin F Dentifrices : Fluoro-Calcium-Phospho-Silicate, Bio-Active glass based tubular occluding formulation"
11347859|NCT04249336|FG002|Participant Flow|Sensodyne Rapid Action|"Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.~Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation."
11347860|NCT04249336|FG003|Participant Flow|Colgate Total|"Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.~Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity"
11347861|NCT04249336|OG000|Outcome|BioMin F|"Participants received BioMin F Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.~BioMin F Dentifrices : Fluoro-Calcium-Phospho-Silicate, Bio-Active glass based tubular occluding formulation"
10858239|NCT00350337|BG002|Baseline|Post-transfection F19|"DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263.~Lyophilized, single dose vials and sterile water for injection~Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose."
10858240|NCT00350337|BG003|Baseline|Placebo|"A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249.~Lyophilized, single dose vials and sterile water for injection.~Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection."
10858241|NCT00350337|BG004|Baseline|Total|Total of all reporting groups
10858242|NCT00350337|FG000|Participant Flow|Pre-transfection F17|"4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.~Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine.~Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection."
10858243|NCT00350337|FG001|Participant Flow|Post-transfection F17|"DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262.~Lyophilized, single dose vials and sterile water for injection.~Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose."
10858244|NCT00350337|FG002|Participant Flow|Post-transfection F19|"DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263.~Lyophilized, single dose vials and sterile water for injection~Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose."
10858245|NCT00350337|FG003|Participant Flow|Placebo|"A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249.~Lyophilized, single dose vials and sterile water for injection.~Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection."
10858246|NCT00350337|OG000|Outcome|Pre-transfection F17|"4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.~Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine.~Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection."
10858247|NCT00350337|OG001|Outcome|Post-transfection F17|"DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262.~Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine~Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose."
10858248|NCT00350337|OG002|Outcome|Post-transfection F19|"DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263.~Lyophilized, single dose vials and sterile water for injection~Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose."
10858249|NCT00350337|OG001|Outcome|Post-transfection F17|"DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262.~Lyophilized, single dose vials and sterile water for injection.~Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose."
10878948|NCT00454805|BG001|Baseline|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
11347862|NCT04249336|OG001|Outcome|Colgate Sensitive Pro Relief|"Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.~Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation"
10858250|NCT00350337|OG003|Outcome|Placebo|"A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249.~Lyophilized, single dose vials and sterile water for injection.~Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection."
10858251|NCT00350337|EG000|Reported Event|Pre-transfection F17|"4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.~Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine"
10858252|NCT00350337|EG001|Reported Event|Post-transfection F17|"monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.~Lyophilized, single dose vials and sterile water for injection"
10858253|NCT00350337|EG002|Reported Event|Post-transfection F19|"4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.~Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines"
10858254|NCT00350337|EG003|Reported Event|Placebo|"A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.~0.5 mL for placebo"
10858255|NCT00350363|BG000|Baseline|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
10858256|NCT00350363|FG000|Participant Flow|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
10858257|NCT00350363|OG000|Outcome|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
10858258|NCT00350363|EG000|Reported Event|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
11347863|NCT04249336|OG002|Outcome|Sensodyne Rapid Action|"Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.~Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation."
10858259|NCT00350402|BG000|Baseline|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
10858260|NCT00350402|BG001|Baseline|Sham MST|Low intensity muscle strength training (5% MIP)
10858261|NCT00350402|BG002|Baseline|Total|Total of all reporting groups
10858262|NCT00350402|FG000|Participant Flow|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
10858263|NCT00350402|FG001|Participant Flow|Sham MST|Low intensity muscle strength training (5% MIP)
10858264|NCT00350402|OG000|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
10858265|NCT00350402|OG001|Outcome|Sham IMST: 5% MIP|"The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
10858266|NCT00350402|OG000|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"Same as previously described. High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
10858267|NCT00350402|OG001|Outcome|Sham IMST: 5% MIP|"Same as previously described. The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
10858268|NCT00350402|OG000|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|high intensity respiratory muscle strength training, 75% MIP
10858269|NCT00350402|OG001|Outcome|Sham IMST: 5% MIP|Low intensity muscle strength training (5% MIP)
10858270|NCT00350402|OG000|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|Same as previously described. This intervention involves high intensity respiratory muscle strength training over 4 week period, 5 days a week, with training device set at 75% maximal inspiratory pressure (MIP). The MIP is determined weekly and the training device recalibrated to take into account changes.
10858271|NCT00350402|OG001|Outcome|Sham IMST: 5% MIP|"This intervention is identical in all ways to real treatment, except that training device requires less inspiratory effort. The training device is set at 5% MIP. )"
10858272|NCT00350402|EG000|Reported Event|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
10858273|NCT00350402|EG001|Reported Event|Sham MST|Low intensity muscle strength training (5% MIP)
10858274|NCT00350519|BG000|Baseline|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
10858275|NCT00350519|BG001|Baseline|STANDARD THERAPY|Participants received standard of care based on the Institution's treatment policy
10858276|NCT00350519|BG002|Baseline|Total|Total of all reporting groups
10858277|NCT00350519|FG000|Participant Flow|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
10858278|NCT00350519|FG001|Participant Flow|STANDARD THERAPY|Participants received standard of care based on the Institution's treatment policy
10858279|NCT00350519|OG000|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
10858280|NCT00350519|OG001|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution's treatment policy
10858281|NCT00350519|EG000|Reported Event|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
10858282|NCT00350519|EG001|Reported Event|STANDARD THERAPY|Participants received standard of care based on the Institution's treatment policy
10858283|NCT00350532|BG000|Baseline|Neuropathic Pain Subjects|Subjects with existing neuropathic pain Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
10858284|NCT00350532|BG001|Baseline|Healthy Subjects|Healthy subjects with no existing pain conditions. Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
11347864|NCT04249336|OG003|Outcome|Colgate Total|"Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.~Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity"
10858285|NCT00350532|BG002|Baseline|Total|Total of all reporting groups
10858286|NCT00350532|FG000|Participant Flow|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
10858287|NCT00350532|FG001|Participant Flow|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
10858288|NCT00350532|OG000|Outcome|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
10858289|NCT00350532|OG001|Outcome|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
10858290|NCT00350532|EG000|Reported Event|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
10858291|NCT00350532|EG001|Reported Event|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
10858292|NCT00350545|BG000|Baseline|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
10858293|NCT00350545|FG000|Participant Flow|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
10858294|NCT00350545|OG000|Outcome|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
10858295|NCT00350545|EG000|Reported Event|Rituximab + Prednisone Arm|"Rituximab will be given as an IV fusion as initial treatment, followed by predisone (given during registration) which will be continued through-out trial and tapered off by physician. Cyclosporine A and tacrolimus will be used if chances of new diagnosis of chronic GVHD occur. Both drugs have no interaction with Rituxan, but will be tapered off after predisone is completely tapered.~Rituximab: 375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9~Prednisone: 1 mg/kg; po per day with taper~Cyclosporine A: trough 200-300 or lower; po~tacrolimus: trough 5-10 or lower; po"
10858296|NCT00350636|BG000|Baseline|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
10858297|NCT00350636|BG001|Baseline|Placebo Topical Gel|1 g placebo topical gel
10858298|NCT00350636|BG002|Baseline|Total|Total of all reporting groups
10858299|NCT00350636|FG000|Participant Flow|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
10858300|NCT00350636|FG001|Participant Flow|Placebo Topical Gel|1 g placebo topical gel
10858301|NCT00350636|OG000|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
10858302|NCT00350636|OG001|Outcome|Placebo Topical Gel|1 g placebo topical gel
10858303|NCT00350636|EG000|Reported Event|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
10858304|NCT00350636|EG001|Reported Event|Placebo Topical Gel|1 g placebo topical gel
10858305|NCT00350727|BG000|Baseline|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
10858306|NCT00350727|BG001|Baseline|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
10858307|NCT00350727|BG002|Baseline|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
10858308|NCT00350727|BG003|Baseline|Total|Total of all reporting groups
10858309|NCT00350727|FG000|Participant Flow|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
10858310|NCT00350727|FG001|Participant Flow|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
10858311|NCT00350727|FG002|Participant Flow|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
10858312|NCT00350727|OG000|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
10858313|NCT00350727|OG001|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
10858314|NCT00350727|OG002|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
10858315|NCT00350727|OG000|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
10858316|NCT00350727|OG001|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
10858317|NCT00350727|OG000|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
10858318|NCT00350727|OG001|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
10858319|NCT00350727|OG002|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
10858320|NCT00350727|OG003|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
10858321|NCT00350727|OG004|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
10858322|NCT00350727|OG005|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
10858323|NCT00350727|OG000|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
10858324|NCT00350727|OG001|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
10858325|NCT00350727|OG000|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
10858326|NCT00350727|EG000|Reported Event|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
10858327|NCT00350727|EG001|Reported Event|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (QD) and lapatinib 1000 mg QD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
10858328|NCT00350727|EG002|Reported Event|Phase II: Biomarker Negative|All participants received pazopanib 400 mg QD and lapatinib 1000 mg QD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
10858329|NCT00350779|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
10858330|NCT00350779|BG001|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
10858331|NCT00350779|BG002|Baseline|Total|Total of all reporting groups
10858332|NCT00350779|FG000|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
10858333|NCT00350779|FG001|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
10858334|NCT00350779|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
10976903|NCT00942604|EG000|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10878949|NCT00454805|BG002|Baseline|Total|Total of all reporting groups
10878950|NCT00454805|FG000|Participant Flow|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
10878951|NCT00454805|FG001|Participant Flow|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
11347865|NCT04249336|EG000|Reported Event|BioMin F Dentifrices|"Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.~Fluoro-Calcium-Phospho-Silicate based dentifrices: Bio-Active glass based formulation"
11347866|NCT04249336|EG001|Reported Event|Colgate Sensitive Pro Relief Trade Mark Dentifrices|"Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.~8% Arginine based dentifrices: Tubular occluding formulation"
11347867|NCT04249336|EG002|Reported Event|Sensodyne Rapid Action Trade Mark Dentifrices|"Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.~8% Strontium Acetate: Tubular occluding formulation"
11347868|NCT04249336|EG003|Reported Event|Colgate Total Trade Mark|"Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.~Sodium Fluoride: No claim of relieving Dentin Hypersensitivity"
11347869|NCT04247581|BG000|Baseline|Cohort 1|"This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening~1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.~Intervention Other: Exercise - All participants will undergo three trials of exercise.~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
11347870|NCT04247581|BG001|Baseline|Cohort 2|"This will include subjects with known persistent or permanent AF who are in AF at the time of screening~1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.~Intervention Other: Exercise - All participants will undergo three trials of exercise.~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
11347871|NCT04247581|BG002|Baseline|Total|Total of all reporting groups
11347872|NCT04247581|FG000|Participant Flow|Cohort 1|"This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening~1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.~Intervention Other: Exercise - All participants will undergo three trials of exercise.~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
11347873|NCT04247581|FG001|Participant Flow|Cohort 2|"This will include subjects with known persistent or permanent AF who are in AF at the time of screening~1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.~Intervention Other: Exercise - All participants will undergo three trials of exercise.~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
11347874|NCT04247581|OG000|Outcome|Cohort 1|"This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening~1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.~Intervention Other: Exercise - All participants will undergo three trials of exercise.~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
11347875|NCT04247581|OG001|Outcome|Cohort 2|"This will include subjects with known persistent or permanent AF who are in AF at the time of screening~1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.~Intervention Other: Exercise - All participants will undergo three trials of exercise.~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
11347876|NCT04247581|EG000|Reported Event|Cohort 1|"This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening~1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.~Intervention Other: Exercise - All participants will undergo three trials of exercise.~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
11347877|NCT04247581|EG001|Reported Event|Cohort 2|"This will include subjects with known persistent or permanent AF who are in AF at the time of screening~1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.~Intervention Other: Exercise - All participants will undergo three trials of exercise.~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
11347878|NCT04247061|BG000|Baseline|Smoking Cessation Intervention|"At a dental cleaning visit, participants will watch a brief educational video that provides guidance and advice on smoking cessation. Participants will then interact with a text program for a month to motivate them to use smoking cessation resources. Participants will also be required to make contact with the resources in order to demonstrate feasibility of study flow.~Educational video: One of two different 10 minute educational videos on smoking cessation will be viewed by participants during a dental cleaning visit. The video that is watched will depend on participants' level of motivation to quit and project needs~Text-message program: A one-month text message program to motivate and facilitate contact with smoking cessation resources."
11347879|NCT04247061|FG000|Participant Flow|Smoking Cessation Intervention|"At a dental cleaning visit, participants will watch a brief educational video that provides guidance and advice on smoking cessation. Participants will then interact with a text program for a month to motivate them to use smoking cessation resources. Participants will also be required to make contact with the resources in order to demonstrate feasibility of study flow.~Educational video: One of two different 10 minute educational videos on smoking cessation will be viewed by participants during a dental cleaning visit. The video that is watched will depend on participants' level of motivation to quit and project needs~Text-message program: A one-month text message program to motivate and facilitate contact with smoking cessation resources."
11348596|NCT04158466|BG001|Baseline|Biotrue ONEday Daily Disposable Contact Lenses|"Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.~Biotrue ONEday Daily Disposable Contact Lenses: Contact lens"
11348597|NCT04158466|BG002|Baseline|Total|Total of all reporting groups
10858335|NCT00350779|OG001|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
10858336|NCT00350779|EG000|Reported Event|Sitagliptin 100 mg Data Through Week 18|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
10858337|NCT00350779|EG001|Reported Event|Placebo Data Through Week 18|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
10858338|NCT00350779|EG002|Reported Event|Sitagliptin 100 mg Data Through Week 54|
10858339|NCT00350779|EG003|Reported Event|Placebo Data Through Week 54|
10858340|NCT00350792|BG000|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
10858341|NCT00350792|FG000|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
10858342|NCT00350792|OG000|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
10858343|NCT00350792|EG000|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
10858344|NCT00350870|BG000|Baseline|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
10858345|NCT00350870|BG001|Baseline|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
10858346|NCT00350870|BG002|Baseline|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
10858347|NCT00350870|BG003|Baseline|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
10858348|NCT00350870|BG004|Baseline|Total|Total of all reporting groups
10858349|NCT00350870|FG000|Participant Flow|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
10858350|NCT00350870|FG001|Participant Flow|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
10858351|NCT00350870|FG002|Participant Flow|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
10858352|NCT00350870|FG003|Participant Flow|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
10858353|NCT00350870|OG000|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
10858354|NCT00350870|OG001|Outcome|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
10858355|NCT00350870|OG002|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
10858356|NCT00350870|OG003|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
10858357|NCT00350870|EG000|Reported Event|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
10858358|NCT00350870|EG001|Reported Event|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
10858359|NCT00350870|EG002|Reported Event|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
10858360|NCT00350870|EG003|Reported Event|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
10858361|NCT00351000|BG000|Baseline|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
10858362|NCT00351000|FG000|Participant Flow|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
10858363|NCT00351000|OG000|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dosage will be unchanged during the trial.
10858364|NCT00351000|OG001|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's olanzapine dosage will be unchanged during the trial.
10858365|NCT00351000|OG000|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
10858366|NCT00351000|OG001|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
10858367|NCT00351000|EG000|Reported Event|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
10858368|NCT00351039|BG000|Baseline|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
10858369|NCT00351039|FG000|Participant Flow|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
10858370|NCT00351039|OG000|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
10858371|NCT00351039|OG000|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
10858372|NCT00351039|EG000|Reported Event|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
10858373|NCT00351273|BG000|Baseline|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
10858374|NCT00351273|BG001|Baseline|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
10858375|NCT00351273|BG002|Baseline|Placebo|Participants will receive placebo
10858376|NCT00351273|BG003|Baseline|Total|Total of all reporting groups
10858377|NCT00351273|FG000|Participant Flow|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
10858378|NCT00351273|FG001|Participant Flow|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
10858379|NCT00351273|FG002|Participant Flow|Placebo|Participants will receive placebo
10858380|NCT00351273|OG000|Outcome|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
10858381|NCT00351273|OG001|Outcome|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
10858382|NCT00351273|OG002|Outcome|Placebo|Participants will receive placebo
10858383|NCT00351273|OG000|Outcome|Azithromycin and Rifampin|"Participants received Azithromycin and Rifampin~Azithromycin and Rifampin: Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months)"
10858384|NCT00351273|OG001|Outcome|Doxycycline and Rifampin|"Participants received Doxycycline and Rifampin~Doxycycline and Rifampin: doxycycline 100mg daily; rifampin 300mg daily (both for 6 months)"
10858385|NCT00351273|OG002|Outcome|Received Placebo|"Participants received placebo~Placebo: Methylcellulose"
10858386|NCT00351273|OG000|Outcome|Combination Antibiotic|Group who recieved either combination of antibiotics
10858387|NCT00351273|OG001|Outcome|Placebo|Group who recieved placebo
10858388|NCT00351273|EG000|Reported Event|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
10858389|NCT00351273|EG001|Reported Event|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
10858390|NCT00351273|EG002|Reported Event|Placebo|Participants will receive placebo
10858391|NCT00351299|BG000|Baseline|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
10858392|NCT00351299|BG001|Baseline|Standard of Care|Standard of care per treating physician preference
10858393|NCT00351299|BG002|Baseline|Total|Total of all reporting groups
10858394|NCT00351299|FG000|Participant Flow|Infusion of Dexmedetomidine|"infusion 0.2-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
10858395|NCT00351299|FG001|Participant Flow|Standard of Care|Standard of care per treating physician preference
10858396|NCT00351299|OG000|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
10845656|NCT00268437|FG000|Participant Flow|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
10976904|NCT00942604|EG001|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
10976905|NCT00942708|BG000|Baseline|Fluoxetine|"Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.~Fluoxetine: :~Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40 mg BID"
10976906|NCT00942708|FG000|Participant Flow|Fluoxetine|"In this single arm study, participants begin fluoxetine at 20 mg daily. If tolerated, the dose is increased every 2 weeks as follows:~Starting dose: 20 mg daily (week 1-2) Next dose: 40 mg daily (week 3-4) Next dose: 40 mg twice daily (week 5-12)~If unable to tolerate uptitration, participants may remain at a lower dose."
11126357|NCT01732874|BG000|Baseline|Expecta 200 mg|"Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.~Expecta 200 mg: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU."
10976907|NCT00942708|OG000|Outcome|Fluoxetine|"Fluoxetine will be started at 20 mg and increased every 2 weeks as tolerated to 80 mg daily.~Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40 mg twice daily"
10976908|NCT00942708|OG000|Outcome|Fluoxetine|Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily
10976909|NCT00942708|EG000|Reported Event|Fluoxetine|"Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.~Fluoxetine:~Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40mg BID"
10976910|NCT00942734|BG000|Baseline|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
11347880|NCT04247061|OG000|Outcome|Smoking Cessation Intervention|"At a dental cleaning visit, participants will watch a brief educational video that provides guidance and advice on smoking cessation. Participants will then interact with a text program for a month to motivate them to use smoking cessation resources. Participants will also be required to make contact with the resources in order to demonstrate feasibility of study flow.~Educational video: One of two different 10 minute educational videos on smoking cessation will be viewed by participants during a dental cleaning visit. The video that is watched will depend on participants' level of motivation to quit and project needs~Text-message program: A one-month text message program to motivate and facilitate contact with smoking cessation resources."
11347881|NCT04247061|EG000|Reported Event|Smoking Cessation Intervention|"At a dental cleaning visit, participants will watch a brief educational video that provides guidance and advice on smoking cessation. Participants will then interact with a text program for a month to motivate them to use smoking cessation resources. Participants will also be required to make contact with the resources in order to demonstrate feasibility of study flow.~Educational video: One of two different 10 minute educational videos on smoking cessation will be viewed by participants during a dental cleaning visit. The video that is watched will depend on participants' level of motivation to quit and project needs~Text-message program: A one-month text message program to motivate and facilitate contact with smoking cessation resources."
11347882|NCT04245202|BG000|Baseline|St-FMOT|Children who received standard face mask oxygen treatment
10858397|NCT00351299|OG001|Outcome|Standard of Care|Standard of Care Per treating attending physician preference
11347883|NCT04245202|BG001|Baseline|HFNCOT|Children who received high flow nasal cannula oxygen treatment
11347884|NCT04245202|BG002|Baseline|Total|Total of all reporting groups
11347885|NCT04245202|FG000|Participant Flow|St-FMOT|Children in the standard-therapy group received supplemental oxygen via a simple face mask, a range of 6-10 L/min, to maintain oxygen saturation level between 92-98%. Those who sustained the oxygen saturation >92% in the ambient oxygen concentration were weaned off Standard face mask oxygen therapy.
11347886|NCT04245202|FG001|Participant Flow|HFNCOT|Children in the high-flow group received heated and humidified high-flow oxygen at a rate of 2 L*kg/min (maximum 25 L/min), using an age-appropriate Optiflow Junior cannula and Airvo 2 high-flow system (Fisher and Paykel Healthcare). The initial fraction of inspired oxygen (FiO2) was set at 40%. The starting flow rate continued for a minimum of 4 hours. According to the patients' clinical response, the flow rate was decreased by 0.5 L*kg/min per hour. The FiO2 was adjusted to obtain the oxygen saturation levels between 92-98%. When the flow rate was at 0.5 L*kg/min, and the FiO2 was equal to the ambient oxygen concentration, High-Flow nasal cannula oxygen therapy was stopped.
11347887|NCT04245202|OG000|Outcome|St-FMOT|Children who received Standard Face Mask Oxygen Therapy
11347888|NCT04245202|OG001|Outcome|HFNCOT|Children who received High-Flow Nasal Cannula Oxygen Therapy
11347889|NCT04245202|OG001|Outcome|HFNCT|Children who received High-Flow Nasal Cannula Oxygen Therapy
11347890|NCT04245202|EG000|Reported Event|Active Comparator: High-Flow Nasal Cannula Oxygen Therapy|Children in the high-flow group received heated and humidified high-flow oxygen at a rate of 2 L*kg/min (maximum 25 L/min), using an age-appropriate Optiflow Junior cannula and Airvo 2 high-flow system (Fisher and Paykel Healthcare). The initial fraction of inspired oxygen (FiO2) was set at 40%. The starting flow rate continued for a minimum of 4 hours. According to the patients' clinical response, the flow rate was decreased by 0.5 L*kg/min per hour. The FiO2 was adjusted to obtain the oxygen saturation levels between 92-98%. When the flow rate was at 0.5 L*kg/min, and the FiO2 was equal to the ambient oxygen concentration, High-Flow nasal cannula oxygen therapy was stopped.
11347891|NCT04245202|EG001|Reported Event|Active Comparator: Standard Face Mask Oxygen Therapy|Children in the standard-therapy group received supplemental oxygen via a simple face mask, a range of 6-10 L/min, to maintain the oxygen saturation level between 92-98%. Those who sustained the oxygen saturation >92% in the ambient oxygen concentration were weaned off Standard Face Mask Oxygen Therapy.
11347892|NCT04243369|BG000|Baseline|Experimental - Collaboration Live Software|Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
11347893|NCT04243369|FG000|Participant Flow|Experimental - Collaboration Live Software|Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
11347894|NCT04243369|OG000|Outcome|Experimental - Collaboration Live Software|Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
11347895|NCT04243369|EG000|Reported Event|Experimental - Collaboration Live Software|Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
11347896|NCT04241146|BG000|Baseline|Standard Blind Technique of Tube Placement|"FDA approved technique of enteral nutrition tube placement~Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition"
10858398|NCT00351299|OG001|Outcome|Standard of Care|Standard of Care Per treating physician preference
10858399|NCT00351299|OG001|Outcome|Standard of Care|Standard of Care Per attending physician preference
10858400|NCT00351299|OG001|Outcome|Standard of Care|Standard of care per attending physician's preference
10858401|NCT00351299|OG001|Outcome|Standard of Care|Standard of Care Per treating physician's preference
10858402|NCT00351299|EG000|Reported Event|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
10858403|NCT00351299|EG001|Reported Event|Standard of Care|Standard of care per treating physician preference
10858404|NCT00351351|BG000|Baseline|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
10858405|NCT00351351|BG001|Baseline|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
10858406|NCT00351351|BG002|Baseline|Total|Total of all reporting groups
10858407|NCT00351351|FG000|Participant Flow|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
10858408|NCT00351351|FG001|Participant Flow|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
10858409|NCT00351351|OG000|Outcome|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
10858410|NCT00351351|OG001|Outcome|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
10858411|NCT00351351|EG000|Reported Event|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
10858412|NCT00351351|EG001|Reported Event|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
10858413|NCT00351377|BG000|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
10858414|NCT00351377|FG000|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
10858415|NCT00351377|OG000|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
10858416|NCT00351377|EG000|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
10858417|NCT00351416|BG000|Baseline|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
10858418|NCT00351416|BG001|Baseline|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
10858419|NCT00351416|BG002|Baseline|Total|Total of all reporting groups
10858420|NCT00351416|FG000|Participant Flow|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
10858421|NCT00351416|FG001|Participant Flow|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
10858422|NCT00351416|OG000|Outcome|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
10858423|NCT00351416|OG001|Outcome|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
10858424|NCT00351416|EG000|Reported Event|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
10858425|NCT00351416|EG001|Reported Event|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
10858426|NCT00351468|BG000|Baseline|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
10858427|NCT00351468|FG000|Participant Flow|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
10858428|NCT00351468|OG000|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
10858429|NCT00351468|EG000|Reported Event|Eltrombopag, Treatment + 1 Day|Eltrombopag, Treatment + 1 day
10858430|NCT00351468|EG001|Reported Event|Eltrombopag, >1 to 30 Days Post-Therapy|Eltrombopag, >1 to 30 Days Post-Therapy
10858431|NCT00351533|BG000|Baseline|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
10858432|NCT00351533|BG001|Baseline|Enteral Saline|7.5cc 0.9% saline every 6 hours
10858433|NCT00351533|BG002|Baseline|Total|Total of all reporting groups
10858434|NCT00351533|FG000|Participant Flow|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
10858435|NCT00351533|FG001|Participant Flow|Enteral Saline|7.5cc 0.9% saline every 6 hours
10858436|NCT00351533|OG000|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
10858437|NCT00351533|OG001|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
10858438|NCT00351533|EG000|Reported Event|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
10858439|NCT00351533|EG001|Reported Event|Enteral Saline|7.5cc 0.9% saline every 6 hours
10858440|NCT00351611|BG000|Baseline|Pregabalin|Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
10858441|NCT00351611|BG001|Baseline|Placebo|Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
10858442|NCT00351611|BG002|Baseline|Total|Total of all reporting groups
10858443|NCT00351611|FG000|Participant Flow|Pregabalin|Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 milligram per day (mg/day) as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
11347897|NCT04241146|BG001|Baseline|CORTRAK Enteral Access System (CEAS) Placement|"An electromagnetic device used to enable enteral nutrition tube placement~CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement"
10858444|NCT00351611|FG001|Participant Flow|Placebo|Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
10858445|NCT00351611|OG000|Outcome|Pregabalin|Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
10858446|NCT00351611|OG001|Outcome|Placebo|Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
10858447|NCT00351611|EG000|Reported Event|Pregabalin|Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
10858448|NCT00351611|EG001|Reported Event|Placebo|Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
10858449|NCT00351741|BG000|Baseline|High Frequency|Intervention with high frequency percussive ventilation
10858450|NCT00351741|BG001|Baseline|Conventional|Low-tidal volume ventilation
10858451|NCT00351741|BG002|Baseline|Total|Total of all reporting groups
10858452|NCT00351741|FG000|Participant Flow|High Frequency|Intervention with high frequency percussive ventilation
10858453|NCT00351741|FG001|Participant Flow|Conventional|Low-tidal volume ventilation
10858454|NCT00351741|OG000|Outcome|High Frequency|Intervention with high frequency percussive ventilation
10858455|NCT00351741|OG001|Outcome|Conventional|Low-tidal volume ventilation
11347898|NCT04241146|BG002|Baseline|Total|Total of all reporting groups
10858456|NCT00351741|EG000|Reported Event|High Frequency|Intervention with high frequency percussive ventilation
10858457|NCT00351741|EG001|Reported Event|Conventional|Low-tidal volume ventilation
10858458|NCT00351819|BG000|Baseline|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
10858459|NCT00351819|BG001|Baseline|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
10858460|NCT00351819|BG002|Baseline|Total|Total of all reporting groups
10858461|NCT00351819|FG000|Participant Flow|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
10858462|NCT00351819|FG001|Participant Flow|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
10858463|NCT00351819|OG000|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
10858464|NCT00351819|OG001|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
10858465|NCT00351819|EG000|Reported Event|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
10858466|NCT00351819|EG001|Reported Event|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
10858467|NCT00351936|BG000|Baseline|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
10976911|NCT00942734|FG000|Participant Flow|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
10976912|NCT00942734|OG000|Outcome|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
10858468|NCT00351936|FG000|Participant Flow|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
10858469|NCT00351936|OG000|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
10858470|NCT00351936|OG001|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
10858471|NCT00351936|EG000|Reported Event|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
10858472|NCT00352001|BG000|Baseline|Lenalidomide and Azacitidine|"azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.~lenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity."
10858473|NCT00352001|FG000|Participant Flow|Lenalidomide and Azacitidine|"azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.~lenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity."
10858474|NCT00352001|OG000|Outcome|Lenalidomide and Azacitidine|"azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.~lenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity."
10858475|NCT00352001|EG000|Reported Event|Lenalidomide and Azacitidine|"azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.~lenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity."
10858476|NCT00352053|BG000|Baseline|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
10858477|NCT00352053|BG001|Baseline|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
10858478|NCT00352053|BG002|Baseline|Total|Total of all reporting groups
10858479|NCT00352053|FG000|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablets plus a genotype-guided optimized background regimen (OBR; 3 minimum (min.)/5 maximum (max.) antiretroviral agents (ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
10858480|NCT00352053|FG001|Participant Flow|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
10858481|NCT00352053|OG000|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
10858482|NCT00352053|OG001|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
10858483|NCT00352053|OG002|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
10858484|NCT00352053|OG003|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
10858485|NCT00352053|OG000|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
10858486|NCT00352053|OG001|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
10858487|NCT00352053|OG002|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
10858488|NCT00352053|OG002|Outcome|Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
10858489|NCT00352053|OG001|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
10858490|NCT00352053|EG000|Reported Event|Tenofovir DF|"Adverse events occurring in the double-blind phase are presented for this reporting group.~TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
10858491|NCT00352053|EG001|Reported Event|Placebo|"Adverse events occurring in the double-blind phase are presented for this reporting group.~Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
10858492|NCT00352053|EG002|Reported Event|All TDF|"Adverse events reported for the All TDF group include those reported during the double-blind phase and/or extension phase for subjects who were randomized to TDF group plus adverse events reported during the extension phase only for subjects who switched from placebo to open-label TDF.~Tenofovir DF 300-mg tablets in participants initially randomized to the Tenofovir DF group, and in those initially randomized to the Placebo group who later switched to open-label TDF 300 mg."
10858493|NCT00352105|BG000|Baseline|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
10858494|NCT00352105|FG000|Participant Flow|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
10858495|NCT00352105|OG000|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
10858496|NCT00352105|EG000|Reported Event|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
10858497|NCT00352365|BG000|Baseline|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
10858498|NCT00352365|FG000|Participant Flow|Lenalidomide|Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
10858499|NCT00352365|OG000|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
10858500|NCT00352365|OG001|Outcome|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
10858501|NCT00352365|OG000|Outcome|Responders|Eligible and evaluable patients who achieved CR/CRi/PR
10858502|NCT00352365|OG001|Outcome|Nonresponders|Eligible and evaluable patients who did not achieve CR/CRi/PR
10858503|NCT00352365|EG000|Reported Event|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
11347899|NCT04241146|FG000|Participant Flow|Standard Blind Technique of Tube Placement|"FDA approved technique of enteral nutrition tube placement~Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition"
10858504|NCT00352365|EG001|Reported Event|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
10858505|NCT00352417|BG000|Baseline|VIA-2291|100-mg dose
10858506|NCT00352417|BG001|Baseline|Matching Placebo|Placebo Dose
10858507|NCT00352417|BG002|Baseline|Total|Total of all reporting groups
10858508|NCT00352417|FG000|Participant Flow|VIA-2291|100-mg dose
10858509|NCT00352417|FG001|Participant Flow|Matching Placebo|Placebo Dose
10858510|NCT00352417|OG000|Outcome|VIA-2291|100-mg dose
10858511|NCT00352417|OG001|Outcome|Matching Placebo|Placebo Dose
10858512|NCT00352417|EG000|Reported Event|VIA-2291|100-mg dose
10858513|NCT00352417|EG001|Reported Event|Matching Placebo|Placebo Dose
10858514|NCT00352612|BG000|Baseline|Group 1|cephalexin arm
10858515|NCT00352612|BG001|Baseline|Group 2|clindamycin arm
10858516|NCT00352612|BG002|Baseline|Total|Total of all reporting groups
10858517|NCT00352612|FG000|Participant Flow|Cephalexin|patients who received cephalexin
10858518|NCT00352612|FG001|Participant Flow|Clindamycin|those who received clindamycin
10858519|NCT00352612|OG000|Outcome|Cephalexin|those patients who received cephalexin
10858520|NCT00352612|OG001|Outcome|Clindamycin|those patients who received clindamycin
10858521|NCT00352612|EG000|Reported Event|Cephalexin|
10858522|NCT00352612|EG001|Reported Event|Clindamycin|
10858523|NCT00352664|BG000|Baseline|Donepezil|Oral Donepezil 5 mg daily x 7 days
10858524|NCT00352664|BG001|Baseline|Placebo|Oral Placebo tablet daily x 7 days
10858525|NCT00352664|BG002|Baseline|Total|Total of all reporting groups
10858526|NCT00352664|FG000|Participant Flow|Donepezil|Oral Donepezil 5 mg daily x 7 days
10858527|NCT00352664|FG001|Participant Flow|Placebo|Oral Placebo tablet daily x 7 days
10858528|NCT00352664|OG000|Outcome|Donepezil|Oral Donepezil 5 mg daily x 7 days
10858529|NCT00352664|OG001|Outcome|Placebo|Oral Placebo tablet daily x 7 days
10858530|NCT00352664|EG000|Reported Event|Donepezil|Oral Donepezil 5 mg daily x 7 days
10858531|NCT00352664|EG001|Reported Event|Placebo|Oral Placebo tablet daily x 7 days
10858532|NCT00352690|BG000|Baseline|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
10858533|NCT00352690|BG001|Baseline|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
10858534|NCT00352690|BG002|Baseline|Total|Total of all reporting groups
10858535|NCT00352690|FG000|Participant Flow|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
10858536|NCT00352690|FG001|Participant Flow|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
10858537|NCT00352690|OG000|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
10858538|NCT00352690|OG001|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
10858539|NCT00352690|EG000|Reported Event|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
10858540|NCT00352690|EG001|Reported Event|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
10858541|NCT00352755|BG000|Baseline|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
10858542|NCT00352755|FG000|Participant Flow|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
10858543|NCT00352755|OG000|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
10858544|NCT00352755|EG000|Reported Event|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m2 over 2 hours with leucovorin at 400 mg/m2 and IV 5-FU at 2400 mg/m2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
10858545|NCT00352781|BG000|Baseline|Nicotine Replacement Therapy (NRT)|Open-label Nicotine Replacement Therapy + counseling
10858546|NCT00352781|FG000|Participant Flow|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy (as per product monograph) + counseling
10858547|NCT00352781|OG000|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
10858548|NCT00352781|EG000|Reported Event|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy + counseling
10858549|NCT00352794|BG000|Baseline|Lenalidomide + Prednisone|"Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.~Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle~Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."
10858550|NCT00352794|FG000|Participant Flow|Lenalidomide + Prednisone|"Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.~Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle~Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."
10858551|NCT00352794|OG000|Outcome|Lenalidomide + Prednisone|"Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.~Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle~Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."
10858552|NCT00352794|EG000|Reported Event|Lenalidomide + Prednisone|"Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.~Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle~Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."
10858553|NCT00352846|BG000|Baseline|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
10858554|NCT00352846|BG001|Baseline|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
10858555|NCT00352846|BG002|Baseline|Total|Total of all reporting groups
10858556|NCT00352846|FG000|Participant Flow|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
10858557|NCT00352846|FG001|Participant Flow|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
10858558|NCT00352846|OG000|Outcome|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
10858559|NCT00352846|OG001|Outcome|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
10858560|NCT00352846|EG000|Reported Event|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
10858561|NCT00352846|EG001|Reported Event|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
10858562|NCT00352885|BG000|Baseline|Escitalopram|Participants receiving 10-20 mg of escitalopram per day from two weeks before IL-2 treatment begins and continuing through the duration of IL-2 treatment. IL-2 treatment consists of four 3-week cycles, for 12 weeks of IL-2 treatment and a total of 14 weeks of the escitalopram intervention.
10858563|NCT00352885|BG001|Baseline|Placebo|Participants receiving a placebo from two weeks before IL-2 treatment begins and continuing through the duration of IL-2 treatment. IL-2 treatment consists of four 3-week cycles, for 12 weeks of IL-2 treatment and a total of 14 weeks of the intervention of a placebo to match escitalopram.
10858564|NCT00352885|BG002|Baseline|Total|Total of all reporting groups
10858565|NCT00352885|FG000|Participant Flow|Escitalopram|Participants receiving 10-20 mg of escitalopram per day from two weeks before IL-2 treatment begins and continuing through the duration of IL-2 treatment. IL-2 treatment consists of four 3-week cycles, for 12 weeks of IL-2 treatment and a total of 14 weeks of the escitalopram intervention.
10858566|NCT00352885|FG001|Participant Flow|Placebo|Participants receiving a placebo from two weeks before IL-2 treatment begins and continuing through the duration of IL-2 treatment. IL-2 treatment consists of four 3-week cycles, for 12 weeks of IL-2 treatment and a total of 14 weeks of the intervention of a placebo to match escitalopram.
10858567|NCT00352885|OG000|Outcome|Escitalopram|Participants receiving 10-20 mg of escitalopram per day from two weeks before IL-2 treatment begins and continuing through the duration of IL-2 treatment. IL-2 treatment consists of four 3-week cycles, for 12 weeks of IL-2 treatment and a total of 14 weeks of the escitalopram intervention.
10858568|NCT00352885|OG001|Outcome|Placebo|Participants receiving a placebo from two weeks before IL-2 treatment begins and continuing through the duration of IL-2 treatment. IL-2 treatment consists of four 3-week cycles, for 12 weeks of IL-2 treatment and a total of 14 weeks of the intervention of a placebo to match escitalopram.
10858569|NCT00352885|EG000|Reported Event|Escitalopram|Participants receiving 10-20 mg of escitalopram per day from two weeks before IL-2 treatment begins and continuing through the duration of IL-2 treatment. IL-2 treatment consists of four 3-week cycles, for 12 weeks of IL-2 treatment and a total of 14 weeks of the escitalopram intervention.
10858570|NCT00352885|EG001|Reported Event|Placebo|Participants receiving a placebo from two weeks before IL-2 treatment begins and continuing through the duration of IL-2 treatment. IL-2 treatment consists of four 3-week cycles, for 12 weeks of IL-2 treatment and a total of 14 weeks of the intervention of a placebo to match escitalopram.
10858571|NCT00352911|BG000|Baseline|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
10858572|NCT00352911|BG001|Baseline|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
10858573|NCT00352911|BG002|Baseline|Total|Total of all reporting groups
10858574|NCT00352911|FG000|Participant Flow|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
10858575|NCT00352911|FG001|Participant Flow|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
10858576|NCT00352911|OG000|Outcome|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
10858577|NCT00352911|OG001|Outcome|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
10858578|NCT00352911|EG000|Reported Event|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
10858579|NCT00352911|EG001|Reported Event|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
10858580|NCT00352976|BG000|Baseline|Treatment With TBI|Patients treated with total body irradiation, Fludarabine, Cyclophosphamide, Bone Marrow Transplantation, Mycophenolate Mofetil, and Sirolimus.
10858581|NCT00352976|FG000|Participant Flow|Treatment With TBI|Patients treated with total body irradiation 300 cGy, Fludarabine 35 mg/m^2 (over 30 minutes daily for 4 days for a total dose of 140 mg/m^2), Cyclophosphamide 10 mg/kg (2 hour infusion for 4 days for a total dose of 40 mg/kg), Bone Marrow Transplantation, Mycophenolate Mofetil 1 mg/kg(over 30 minutes every 12 hours for 5 days) , and Sirolimus.
10858582|NCT00352976|OG000|Outcome|Treatment With TBI|Patients treated with total body irradiation, Fludarabine, Cyclophosphamide, Bone Marrow Transplantation, Mycophenolate Mofetil, and Sirolimus.
10858583|NCT00352976|OG000|Outcome|Treatment With TBI|Average IgG levels as a measure of immune reconstitution after transplant
10858584|NCT00352976|EG000|Reported Event|Treatment With TBI|Patients treated with total body irradiation, Fludarabine, Cyclophosphamide, Bone Marrow Transplantation, Mycophenolate Mofetil, and Sirolimus.
10858585|NCT00353119|BG000|Baseline|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
11347900|NCT04241146|FG001|Participant Flow|CORTRAK Enteral Access System (CEAS) Placement|"An electromagnetic device used to enable enteral nutrition tube placement~CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement"
10858586|NCT00353119|BG001|Baseline|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
10858587|NCT00353119|BG002|Baseline|Total|Total of all reporting groups
10858588|NCT00353119|FG000|Participant Flow|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
10858589|NCT00353119|FG001|Participant Flow|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
10858590|NCT00353119|OG000|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
10858591|NCT00353119|OG001|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
10858592|NCT00353119|OG001|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND Patients that crossed over to etanercept 50 mg subcutanously twice weekly after taking placebo for the first 12 weeks.
10858593|NCT00353119|OG000|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
10858594|NCT00353119|OG000|Outcome|Etanercept After Placebo|Group 1 patients that crossed over to etanercept 50mg twice weekly for weeks 12 to 24 after having initiated the study with placebo for the first 12 weeks
10858595|NCT00353119|EG000|Reported Event|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks
10858596|NCT00353119|EG001|Reported Event|Etanercept|Patients randomized to etanercept who received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND patients who crossed over to etanercept 50 mg subcutaneously twice a week for 12 weeks.
10858597|NCT00353262|BG000|Baseline|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
10858598|NCT00353262|FG000|Participant Flow|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
10878952|NCT00454805|OG000|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
10878953|NCT00454805|OG001|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
10858599|NCT00353262|OG000|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
10858600|NCT00353262|EG000|Reported Event|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
10858601|NCT00353301|BG000|Baseline|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
10858602|NCT00353301|FG000|Participant Flow|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
10858603|NCT00353301|OG000|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
10858604|NCT00353301|EG000|Reported Event|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
10858605|NCT00353366|BG000|Baseline|Rotarix Group|Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
10858606|NCT00353366|FG000|Participant Flow|Rotarix Group|Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
10858607|NCT00353366|OG000|Outcome|Rotarix Group|Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
10858608|NCT00353366|EG000|Reported Event|Rotarix Group|Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
10858609|NCT00353418|BG000|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
10858610|NCT00353418|BG001|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
10858611|NCT00353418|BG002|Baseline|Total|Total of all reporting groups
10858612|NCT00353418|FG000|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
10858613|NCT00353418|FG001|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
10858614|NCT00353418|OG000|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
10858615|NCT00353418|OG001|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
10858616|NCT00353418|EG000|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
10858617|NCT00353418|EG001|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
10858618|NCT00353431|BG000|Baseline|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
10858619|NCT00353431|BG001|Baseline|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
10858620|NCT00353431|BG002|Baseline|Total|Total of all reporting groups
10858621|NCT00353431|FG000|Participant Flow|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
10976913|NCT00942734|EG000|Reported Event|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
10976914|NCT00942786|BG000|Baseline|One Arm|consecutive patients presenting for emergent non-cardiac surgery
11347901|NCT04241146|OG000|Outcome|Standard Blind Technique of Tube Placement|"FDA approved technique of enteral nutrition tube placement~Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition"
10858622|NCT00353431|FG001|Participant Flow|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
10858623|NCT00353431|OG000|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
10858624|NCT00353431|OG001|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
10858625|NCT00353431|EG000|Reported Event|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
10858626|NCT00353431|EG001|Reported Event|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
10858627|NCT00353496|BG000|Baseline|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
10858628|NCT00353496|BG001|Baseline|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
10858629|NCT00353496|BG002|Baseline|Total|Total of all reporting groups
10858630|NCT00353496|FG000|Participant Flow|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
10858631|NCT00353496|FG001|Participant Flow|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
10858632|NCT00353496|OG000|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
10858633|NCT00353496|OG001|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
10858634|NCT00353496|OG000|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
11347902|NCT04241146|OG001|Outcome|CORTRAK Enteral Access System (CEAS) Placement|"An electromagnetic device used to enable enteral nutrition tube placement~CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement"
10858635|NCT00353496|EG000|Reported Event|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
10858636|NCT00353496|EG001|Reported Event|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
10858637|NCT00353522|BG000|Baseline|Dalcetrapib|"Dalcetrapib 900mg po daily for 24 weeks~dalcetrapib: 900mg po daily for 24 weeks"
10858638|NCT00353522|BG001|Baseline|Placebo|"Placebo po daily for 24 weeks~Placebo: po daily for 24 weeks"
10858639|NCT00353522|BG002|Baseline|Total|Total of all reporting groups
10858640|NCT00353522|FG000|Participant Flow|Dalcetrapib|"Dalcetrapib 900mg po daily for 24 weeks~dalcetrapib: 900mg po daily for 24 weeks"
10858641|NCT00353522|FG001|Participant Flow|Placebo|"Placebo po daily for 24 weeks~Placebo: po daily for 24 weeks"
10858642|NCT00353522|OG000|Outcome|Dalcetrapib|"Dalcetrapib 900mg po daily for 24 weeks~dalcetrapib: 900mg po daily for 24 weeks"
10858643|NCT00353522|OG001|Outcome|Placebo|"Placebo po daily for 24 weeks~Placebo: po daily for 24 weeks"
10858644|NCT00353522|EG000|Reported Event|Dalcetrapib|"Dalcetrapib 900mg po daily for 24 weeks~dalcetrapib: 900mg po daily for 24 weeks"
10858645|NCT00353522|EG001|Reported Event|Placebo|"Placebo po daily for 24 weeks~Placebo: po daily for 24 weeks"
10858646|NCT00353652|BG000|Baseline|Participants Study#1|"study #1 has 2 arms. Arm 1. chlorthalidone (CTD) first then spironolactone (SP): subjects are randomized to receive 3 months of CTD first (12.5-25 mg/d), titrated to achieve 24-h BP < 130/80 mmHg. Then, the subject is transitioned to treatment with spironolactone (25-75 mg/d) without washout period for 3 months. Following 3 month treatment period, sympathetic nerve activity, 24 h-ambulatory BP, fasting plasma glucose, insulin, HOMA IR, and baroreflex sensitivity are measured. After completion of the study procedures, the medication is discontinued.~Arm 2. spironolactone (SP) first, then chlorthalidone (CTD): subjects are randomized to receive 3 months spironolactone first (25-75 mg/d), titrated to achieve 24-h BP < 130/80 mmHg. Then, the subject is switched to CTD (12.5-25 mg/d) without washout period. Following 3 month treatment period, sympathetic nerve activity, 24 h-ambulatory BP, fasting plasma glucose, insulin, HOMA IR, and baroreflex sensitivity are measured."
10858647|NCT00353652|BG001|Baseline|Participants Study#2|"study #2 has 6 arms. Arm 1. CTD alone 1st, CTD+ SP 2nd, CTD+IR 3rd: Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first, using a single-blind 3-phase crossover design. Then, subjects are treated with fixed-dose CTD (25 mg/d) plus fixed-dosespironolactone (SP) 25 mg daily for 3 months, then fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) for 3 months.~Arm 2. fixed-dose CTD alone 1st, CTD+IR 2nd, CTD+SP3rd Arm3. fixed-dose CTD+SP1st, CTD alone 2nd, CTD+IR 3rd Arm 4. fixed-dose CTD+SP1st, CTD+IR 2nd, CTD alone 3rd Arm 5. CTD+IR 1st, CTD alone 2nd, CTD+SP 3rd Arm 6. CTD+IR 1st, CTD+SP 2nd, CTD alone 3rd"
10858648|NCT00353652|BG002|Baseline|Total|Total of all reporting groups
10976915|NCT00942786|FG000|Participant Flow|No Treatment|Consecutive patients undergoing emergency surgery
10858649|NCT00353652|FG000|Participant Flow|Study#1: Chlorthalidone (CTD) First Then Spironolactone (SP)|Participants in study #1 only received 2 interventions. All subjects are randomized to receive 3 months of chlorthalidone first (12.5-25 mg/d), using a single-blind 2-phase crossover design. Then, the subject is transitioned to treatment with spironolactone (25-75 mg/d)without washout period for 3 months. Following 3 month treatment period, the procedures listed below were performed. After completion of the study procedures, the medication is discontinued.
10858650|NCT00353652|FG001|Participant Flow|Study #1: Spironolactone (SP) First, Then Chlorthalidone (CTD)|Participants in study #1 only received 2 interventions. All subjects are randomized to receive 3 months spironolactone first (25-75 mg/d), using a single-blind 2-phase crossover design. Then, the subject is transitioned to treatment with chlorthalidone(12.5-25 mg/d) without washout period. Following 3 month treatment period, the procedures listed below were performed. After completion of the study procedures, the medication is discontinued.
10858651|NCT00353652|FG002|Participant Flow|Study# 2 CTD Alone 1st, CTD+ SP 2nd, CTD+IR 3rd|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first, using a single-blind 3-phase crossover design. Then, subjects are treated with fixed-dose CTD (25 mg/d) plus fixed-dosespironolactone (SP) 25 mg daily for 3 months, then fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) for 3 months. After completion of the study procedures, the medication is discontinued.
10858652|NCT00353652|FG003|Participant Flow|Study# 2 CTD Alone 1st, CTD+IR 2nd, CTD+SP3rd|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first, using a single-blind 3-phase crossover design. Then, subjects are treated with fixed-dose CTD 25 mg/d plus fixed-dose irbsesartan (IR, 150 mg daily) for 3 months, followed by fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily for 3 months. After completion of the study procedures, the medication is discontinued.
10858653|NCT00353652|FG004|Participant Flow|Study# 2 CTD+SP1st, CTD Alone 2nd, CTD+IR 3rd|Subjects are randomized to receive fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily for 3 months, using a single-blind 3-phase crossover design. Then, subjects are treated with fixed-dose CTD 25 mg/d alone for 3 months, then fixed-dose CTD 25 mg/d plus fixed-dose irbsesartan (IR, 150 mg daily) for 3 months. After completion of the study procedures, the medication is discontinued.
10858654|NCT00353652|FG005|Participant Flow|Study# 2 CTD+SP1st, CTD+IR 2nd, CTD Alone 3rd|Subjects are randomized to receive fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily for 3 months, using a single-blind 3-phase crossover design. Then, subjects are treated with fixed-dose CTD 25 mg/d plus fixed-dose irbsesartan (IR, 150 mg daily) for 3 months, then fixed-dose CTD 25 mg/d alone for 3 months. After completion of the study procedures, the medication is discontinued.
10858655|NCT00353652|FG006|Participant Flow|Study# 2 CTD+IR 1st, CTD Alone 2nd, CTD+SP 3rd|Subjects are randomized to receive fixed-dose CTD 25 mg/d plus fixed-dose irbsesartan (IR, 150 mg daily) for 3 months, using a single-blind 3-phase crossover design. Then, subjects are treated with fixed-dose CTD 25 mg/d alone for 3 months, then fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily for 3 months. After completion of the study procedures, the medication is discontinued.
10858656|NCT00353652|FG007|Participant Flow|Study# 2 CTD+IR 1st, CTD+SP 2nd, CTD Alone 3rd|Subjects are randomized to receive fixed-dose CTD 25 mg/d plus fixed-dose irbsesartan (IR, 150 mg daily) for 3 months, using a single-blind 3-phase crossover design. Then, subjects are treated with fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily for 3 months, followed by fixed-dose CTD 25 mg/d alone for 3 months. After completion of the study procedures, the medication is discontinued.
10858657|NCT00353652|OG000|Outcome|Study#1: Chlorthalidone (CTD), Titrated Dose|Participants in study #1 only received 2 interventions. All subjects are randomized to receive 3 months of chlorthalidone first (12.5-25 mg/d) or spironolactone (25-75 mg/d) first at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg, using a single-blind 2-phase crossover design. Then, the subject is transitioned to treatment the remain arm without washout period for 3 months. Following 3 month treatment period, measurement of outcomes are performed. After completion of the study procedures, the medication is discontinued.
10858658|NCT00353652|OG001|Outcome|Study #1: Spironolactone (SP), Titrated Dose|Participants in study #1 only received 2 interventions. All subjects are randomized to receive 3 months of spironolactone (25-75 mg/d) first or chlorthalidone first (12.5-25 mg/d) at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg, using a single-blind 2-phase crossover design. Then, the subject is transitioned to treatment the remain arm without washout period for 3 months. Following 3 month treatment period, measurement of outcomes are performed. After completion of the study procedures, the medication is discontinued.
10858659|NCT00353652|OG002|Outcome|Study# 2 Chlorthalidone (CTD), Fixed Dose|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first or fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily first or fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) first, using a single-blind 3-phase crossover design. Then, subjects are treated with the remaining one of the 2 arms for 3 months, followed by the last arm for 3 months without washout period. After completion of the study procedures, the medication is discontinued.
10858660|NCT00353652|OG003|Outcome|Study# 2 CTD Fixed Dose 25 mg/d Plus SP Fixed Dose|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first or fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily first or fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) first, using a single-blind 3-phase crossover design. Then, subjects are treated with the remaining one of the 2 arms for 3 months, followed by the last arm for 3 months without washout period. After completion of the study procedures, the medication is discontinued.
10858661|NCT00353652|OG004|Outcome|Study# 2 CTD Fixed Dose 25 mg/d Plus IR Fixed Dose|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first or fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily first or fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) first, using a single-blind 3-phase crossover design. Then, subjects are treated with the remaining one of the 2 arms for 3 months, followed by the last arm for 3 months without washout period. After completion of the study procedures, the medication is discontinued.
10976916|NCT00942786|OG000|Outcome|No Treatment|Consecutive patients undergoing emergency surgery
10976917|NCT00942786|OG000|Outcome|All Patients|Consecutive patients undergoing emergent non-cardiac surgery
11347903|NCT04241146|EG000|Reported Event|Standard Blind Technique of Tube Placement|"FDA approved technique of enteral nutrition tube placement~Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition"
11347904|NCT04241146|EG001|Reported Event|CORTRAK Enteral Access System (CEAS) Placement|"An electromagnetic device used to enable enteral nutrition tube placement~CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement"
11347905|NCT04240678|BG000|Baseline|HBV Alert Group|Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients
11347906|NCT04240678|BG001|Baseline|Control Group|No Alert
11347907|NCT04240678|BG002|Baseline|Total|Total of all reporting groups
11347908|NCT04240678|FG000|Participant Flow|HBV Alert Group|Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients
11347909|NCT04240678|FG001|Participant Flow|Control Group|No alert
11347910|NCT04240678|OG000|Outcome|HBV Alert Group|Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients
11347911|NCT04240678|OG001|Outcome|Control Group|No alert
11347912|NCT04240678|EG000|Reported Event|HBV Alert Group|Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients
11347913|NCT04240678|EG001|Reported Event|Control Group|No alert
11347914|NCT04238650|BG000|Baseline|MB02 (Bevacizumab Biosimilar)|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion"
11347915|NCT04238650|BG001|Baseline|EU Approved Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion"
11347916|NCT04238650|BG002|Baseline|Total|Total of all reporting groups
11347917|NCT04238650|FG000|Participant Flow|MB02 (Bevacizumab Biosimilar)|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion"
11347918|NCT04238650|FG001|Participant Flow|EU Approved Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion"
11347919|NCT04238650|OG000|Outcome|MB02 (Bevacizumab Biosimilar)|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion"
11347920|NCT04238650|OG001|Outcome|EU Approved Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion"
11347921|NCT04238650|EG000|Reported Event|MB02 (Bevacizumab Biosimilar)|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion"
11347922|NCT04238650|EG001|Reported Event|EU Approved Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion"
11347923|NCT04238663|BG000|Baseline|MB02 (Bevacizumab Biosimilar)|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347924|NCT04238663|BG001|Baseline|EU Approved Avastin®|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347925|NCT04238663|BG002|Baseline|US Licenced Avastin®|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347926|NCT04238663|BG003|Baseline|Total|Total of all reporting groups
11347927|NCT04238663|FG000|Participant Flow|MB02 (Bevacizumab Biosimilar)|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347928|NCT04238663|FG001|Participant Flow|EU Approved Avastin®|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347929|NCT04238663|FG002|Participant Flow|US Licenced Avastin®|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347930|NCT04238663|OG000|Outcome|MB02 (Bevacizumab Biosimilar)|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347931|NCT04238663|OG001|Outcome|EU Approved Avastin®|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347932|NCT04238663|OG002|Outcome|US Licenced Avastin®|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347933|NCT04238663|EG000|Reported Event|MB02 (Bevacizumab Biosimilar)|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
10976918|NCT00942786|OG000|Outcome|Patients Sustaining Adverse Events|Subjects who reached the primary endpoint
11347934|NCT04238663|EG001|Reported Event|EU Approved Avastin®|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347935|NCT04238663|EG002|Reported Event|US Licenced Avastin®|"Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion"
11347936|NCT04235582|BG000|Baseline|Outcomes Group|"During the intervention period, the Outcomes group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use.~App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests)."
11347937|NCT04235582|BG001|Baseline|Inputs Group|"Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include:~Drug adherence to prescribed SUD pharmacotherapy~Attendance at individual and group psychotherapy sessions~App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology)."
11347938|NCT04235582|BG002|Baseline|Combination Group|"Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for:~Drug adherence to prescribed SUD pharmacotherapy~Attendance at individual and group psychotherapy sessions~Random saliva tests~App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).~App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests)."
11347939|NCT04235582|BG003|Baseline|Total|Total of all reporting groups
11347940|NCT04235582|FG000|Participant Flow|Outcomes Group|"During the intervention period, the Outcomes group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use."
11347941|NCT04235582|FG001|Participant Flow|Inputs Group|"Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include:~Drug adherence to prescribed SUD pharmacotherapy~Attendance at individual and group psychotherapy sessions"
11347942|NCT04235582|FG002|Participant Flow|Combination Group|"Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for:~Drug adherence to prescribed SUD pharmacotherapy~Attendance at individual and group psychotherapy sessions~Random saliva tests~App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology)."
11347943|NCT04235582|OG000|Outcome|Outcomes Group|"During the intervention period, the Outcomes group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use.~App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests)."
11347944|NCT04235582|OG001|Outcome|Inputs Group|"Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include:~Drug adherence to prescribed SUD pharmacotherapy~Attendance at individual and group psychotherapy sessions~App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology)."
11348598|NCT04158466|FG000|Participant Flow|Kalifilcon A Daily Disposable Contact Lenses|"Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.~Kalifilcon A Daily Disposable Contact Lenses: Contact lens"
11126358|NCT01732874|BG001|Baseline|Expecta 1 Gram|"Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.~Expecta 1 gram: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU."
11126359|NCT01732874|BG002|Baseline|Total|Total of all reporting groups
10858662|NCT00353652|OG001|Outcome|Study #1: Spironolactone (SP), Titrated Dose|Participants in study #1 only received 2 interventions. All subjects are randomized to receive 3 months of chlorthalidone first (12.5-25 mg/d) or spironolactone (25-75 mg/d) first at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg, using a single-blind 2-phase crossover design. Then, the subject is transitioned to treatment the remain arm without washout period for 3 months. Following 3 month treatment period, measurement of outcomes are performed. After completion of the study procedures, the medication is discontinued.
10858663|NCT00353652|OG002|Outcome|Study# 2 CTD Fixed Dose 25 mg/d|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first or fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily first or fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) first, using a single-blind 3-phase crossover design. Then, subjects are treated with the remaining one of the 2 arms for 3 months, followed by the last arm for 3 months without washout period. After completion of the study procedures, the medication is discontinued.
10858664|NCT00353652|OG001|Outcome|Drug: Study #1: Spironolactone (SP), Titrated Dose|Participants in study #1 only received 2 interventions. All subjects are randomized to receive 3 months of spironolactone (25-75 mg/d) first or chlorthalidone first (12.5-25 mg/d) at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg, using a single-blind 2-phase crossover design. Then, the subject is transitioned to treatment the remain arm without washout period for 3 months. Following 3 month treatment period, measurement of outcomes are performed. After completion of the study procedures, the medication is discontinued.
10858665|NCT00353652|EG000|Reported Event|Study#1: Chlorthalidone (CTD), Titrated Dose|Participants in study #1 only received 2 interventions. All subjects are randomized to receive 3 months of chlorthalidone first (12.5-25 mg/d) or spironolactone (25-75 mg/d) first at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg, using a single-blind 2-phase crossover design. Then, the subject is transitioned to treatment the remain arm without washout period for 3 months. Following 3 month treatment period, measurement of outcomes are performed. After completion of the study procedures, the medication is discontinued.
10858666|NCT00353652|EG001|Reported Event|Study #1: Spironolactone (SP), Titrated Dose|Participants in study #1 only received 2 interventions. All subjects are randomized to receive 3 months of spironolactone (25-75 mg/d) first or chlorthalidone first (12.5-25 mg/d) at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg, using a single-blind 2-phase crossover design. Then, the subject is transitioned to treatment the remain arm without washout period for 3 months. Following 3 month treatment period, measurement of outcomes are performed. After completion of the study procedures, the medication is discontinued.
10858667|NCT00353652|EG002|Reported Event|Study# 2 Chlorthalidone (CTD), Fixed Dose|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first or fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily first or fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) first, using a single-blind 3-phase crossover design. Then, subjects are treated with the remaining one of the 2 arms for 3 months, followed by the last arm for 3 months without washout period. After completion of the study procedures, the medication is discontinued.
10858668|NCT00353652|EG003|Reported Event|Study# 2 CTD Fixed Dose 25 mg/d Plus SP Fixed Dose|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first or fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily first or fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) first, using a single-blind 3-phase crossover design. Then, subjects are treated with the remaining one of the 2 arms for 3 months, followed by the last arm for 3 months without washout period. After completion of the study procedures, the medication is discontinued.
10858669|NCT00353652|EG004|Reported Event|Study# 2 CTD Fixed Dose 25 mg/d Plus IR Fixed Dose|Subjects are randomized to receive 3 months of fixed-dose chlorthalidone (CTD, 25 mg/d) alone first or fixed-dose CTD (25 mg/d) plus fixed-dose spironolactone (SP) 25 mg daily first or fixed-dose CTD (25 mg/d) plus fixed-dose irbsesartan (IR, 150 mg daily) first, using a single-blind 3-phase crossover design. Then, subjects are treated with the remaining one of the 2 arms for 3 months, followed by the last arm for 3 months without washout period. After completion of the study procedures, the medication is discontinued.
10858670|NCT00353704|BG000|Baseline|Pregabalin|
10858671|NCT00353704|BG001|Baseline|Placebo|
10858672|NCT00353704|BG002|Baseline|Total|Total of all reporting groups
10858673|NCT00353704|FG000|Participant Flow|Pregabalin|
10858674|NCT00353704|FG001|Participant Flow|Placebo|
10858675|NCT00353704|OG000|Outcome|Pregabalin|
10858676|NCT00353704|OG001|Outcome|Placebo|
10858677|NCT00353704|EG000|Reported Event|Pregabalin|
10858678|NCT00353704|EG001|Reported Event|Placebo|
10858679|NCT00353795|BG000|Baseline|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
10858680|NCT00353795|FG000|Participant Flow|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
10858681|NCT00353795|OG000|Outcome|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
10858682|NCT00353795|EG000|Reported Event|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
10858683|NCT00353834|BG000|Baseline|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
10858684|NCT00353834|BG001|Baseline|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
10858685|NCT00353834|BG002|Baseline|Total|Total of all reporting groups
10976919|NCT00942786|OG001|Outcome|Patients Not Sustaining Adverse Events|Subjects who did not reach the primary endpoint
10858686|NCT00353834|FG000|Participant Flow|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
10858687|NCT00353834|FG001|Participant Flow|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
10858688|NCT00353834|OG000|Outcome|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
10858689|NCT00353834|OG001|Outcome|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
10858690|NCT00353834|EG000|Reported Event|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
10858691|NCT00353834|EG001|Reported Event|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
10858692|NCT00353873|BG000|Baseline|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
10858693|NCT00353873|BG001|Baseline|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
10858694|NCT00353873|BG002|Baseline|Total|Total of all reporting groups
10858695|NCT00353873|FG000|Participant Flow|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
10858696|NCT00353873|FG001|Participant Flow|Salmeterol/Fluticasone Propionate (SFC) 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
10858697|NCT00353873|OG000|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
10858698|NCT00353873|OG001|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
10858699|NCT00353873|EG000|Reported Event|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
10858700|NCT00353873|EG001|Reported Event|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
10858701|NCT00353977|BG000|Baseline|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
10858702|NCT00353977|FG000|Participant Flow|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
10858703|NCT00353977|OG000|Outcome|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
10858704|NCT00353977|EG000|Reported Event|Alvac pp65 Vaccine|Subjects received 1, 2 or 3 doses of the vaccine
10858705|NCT00354029|BG000|Baseline|S (+) Ketamine|
10858706|NCT00354029|BG001|Baseline|Placebo|
10858707|NCT00354029|BG002|Baseline|Total|Total of all reporting groups
10858708|NCT00354029|FG000|Participant Flow|S (+) Ketamine|
10858709|NCT00354029|FG001|Participant Flow|Placebo|
10858710|NCT00354029|OG000|Outcome|S (+) Ketamine|
10858711|NCT00354029|OG001|Outcome|Placebo|
10858712|NCT00354029|EG000|Reported Event|S (+) Ketamine|
10858713|NCT00354029|EG001|Reported Event|Placebo|
10858714|NCT00354107|BG000|Baseline|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
10858715|NCT00354107|FG000|Participant Flow|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
10858716|NCT00354107|OG000|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
10858717|NCT00354107|EG000|Reported Event|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
10858718|NCT00354159|BG000|Baseline|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
10858719|NCT00354159|BG001|Baseline|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
10858720|NCT00354159|BG002|Baseline|Total|Total of all reporting groups
10858721|NCT00354159|FG000|Participant Flow|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
10858722|NCT00354159|FG001|Participant Flow|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
10858723|NCT00354159|OG000|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.
10858724|NCT00354159|OG000|Outcome|Chronicle IHM Implanted Subjects|Analysis cohort includes the one subject with a Chronicle IHM implant attempt
10858725|NCT00354159|OG000|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
10858726|NCT00354159|OG001|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
10858727|NCT00354159|OG001|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
10976920|NCT00942786|EG000|Reported Event|One Arm|"consecutive patients presenting for emergent non-cardiac surgery~Patients were followed for occurence of major adverse cardiac events"
10858728|NCT00354159|OG000|Outcome|Heart Failure Event Free Control Subjects|Subjects randomized to the Control Arm that did not have a heart failure related event during the 12-month randomized period
10858729|NCT00354159|OG001|Outcome|Heart Failure Event Control Subjects|Subjects randomized to the Control Arm that had a heart failure event during the 12-month randomized period
10858730|NCT00354159|OG000|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
10858731|NCT00354159|EG000|Reported Event|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
10858732|NCT00354159|EG001|Reported Event|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
10858733|NCT00354159|EG002|Reported Event|Enrolled, Not Randomized|42 subjects were enrolled but exited the study prior to randomization
10858734|NCT00354172|BG000|Baseline|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
10858735|NCT00354172|FG000|Participant Flow|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
10858736|NCT00354172|OG000|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
10858737|NCT00354172|EG000|Reported Event|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
10976921|NCT00942825|BG000|Baseline|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
10858738|NCT00354224|BG000|Baseline|Oxaliplatin + Capecitabine|"Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.~capecitabine~oxaliplatin"
10858739|NCT00354224|FG000|Participant Flow|Oxaliplatin + Capecitabine|"Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.~capecitabine~oxaliplatin"
10858740|NCT00354224|OG000|Outcome|Oxaliplatin + Capecitabine|"Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.~capecitabine~oxaliplatin"
10858741|NCT00354224|EG000|Reported Event|Oxaliplatin + Capecitabine|"Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.~capecitabine~oxaliplatin"
10858742|NCT00354341|BG000|Baseline|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant's Hb level. Standard treatment was as per investigator discretion.
10858743|NCT00354341|BG001|Baseline|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
10858744|NCT00354341|BG002|Baseline|Total|Total of all reporting groups
10858745|NCT00354341|FG000|Participant Flow|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses were adjusted according to individual participant's Hb level. Standard treatment was as per investigator discretion.
10858746|NCT00354341|FG001|Participant Flow|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
10858747|NCT00354341|OG000|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant's Hb level. Standard treatment was as per investigator discretion.
10858748|NCT00354341|OG001|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
10858749|NCT00354341|EG000|Reported Event|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant's Hb level. Standard treatment was as per investigator discretion.
10858750|NCT00354341|EG001|Reported Event|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
10858751|NCT00354432|BG000|Baseline|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
10858752|NCT00354432|BG001|Baseline|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
10858753|NCT00354432|BG002|Baseline|Arm III - Venlafaxine|Patients receive oral venlafaxine pill and oral placebo powder once daily.
10858754|NCT00354432|BG003|Baseline|Arm IV - Soy + Venlafaxine|Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
10858755|NCT00354432|BG004|Baseline|Total|Total of all reporting groups
10858756|NCT00354432|FG000|Participant Flow|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
10858757|NCT00354432|FG001|Participant Flow|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
10858758|NCT00354432|FG002|Participant Flow|Arm III - Venlafaxine|Patients receive oral venlafaxine pill and oral placebo powder once daily.
10858759|NCT00354432|FG003|Participant Flow|Arm IV - Soy + Venlafaxin|Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
10858760|NCT00354432|OG000|Outcome|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
10858761|NCT00354432|OG001|Outcome|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
10858762|NCT00354432|OG002|Outcome|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
10858763|NCT00354432|OG003|Outcome|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
10858764|NCT00354432|EG000|Reported Event|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
10858765|NCT00354432|EG001|Reported Event|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
10858766|NCT00354432|EG002|Reported Event|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
10858767|NCT00354432|EG003|Reported Event|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
10858768|NCT00354484|BG000|Baseline|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
10858769|NCT00354484|BG001|Baseline|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
10858770|NCT00354484|BG002|Baseline|Total|Total of all reporting groups
10858771|NCT00354484|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
10858772|NCT00354484|FG001|Participant Flow|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
10858773|NCT00354484|OG000|Outcome|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
10858774|NCT00354484|OG001|Outcome|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
10858775|NCT00354484|EG000|Reported Event|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
10858776|NCT00354484|EG001|Reported Event|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
10858777|NCT00354601|BG000|Baseline|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
10858778|NCT00354601|FG000|Participant Flow|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
10858779|NCT00354601|OG000|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
10858780|NCT00354601|EG000|Reported Event|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
10858781|NCT00354614|BG000|Baseline|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
10858782|NCT00354614|FG000|Participant Flow|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
10858783|NCT00354614|OG000|Outcome|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
10858784|NCT00354614|EG000|Reported Event|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
10858785|NCT00354640|BG000|Baseline|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
10858786|NCT00354640|FG000|Participant Flow|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
10858787|NCT00354640|OG000|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
10858788|NCT00354640|EG000|Reported Event|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
10858789|NCT00354679|BG000|Baseline|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
10858790|NCT00354679|FG000|Participant Flow|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
10858791|NCT00354679|OG000|Outcome|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
10858792|NCT00354679|EG000|Reported Event|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
10858793|NCT00354744|BG000|Baseline|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
10858794|NCT00354744|FG000|Participant Flow|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
10858795|NCT00354744|OG000|Outcome|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients
10845657|NCT00268437|OG000|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~conventional surgery"
11347945|NCT04235582|OG002|Outcome|Combination Group|"Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for:~Drug adherence to prescribed SUD pharmacotherapy~Attendance at individual and group psychotherapy sessions~Random saliva tests~App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).~App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests)."
11347946|NCT04235582|EG000|Reported Event|Outcomes Group|"During the intervention period, the Outcomes group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use.~App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests)."
11347947|NCT04235582|EG001|Reported Event|Inputs Group|"Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include:~Drug adherence to prescribed SUD pharmacotherapy~Attendance at individual and group psychotherapy sessions~App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology)."
11347948|NCT04235582|EG002|Reported Event|Combination Group|"Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for:~Drug adherence to prescribed SUD pharmacotherapy~Attendance at individual and group psychotherapy sessions~Random saliva tests~App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).~App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests)."
11347949|NCT04203225|BG000|Baseline|Single LET|"One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes~LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic"
11347950|NCT04203225|BG001|Baseline|Triple LET|"Three applications of LET topical gel, one applied every 10 minutes~LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic"
11347951|NCT04203225|BG002|Baseline|Total|Total of all reporting groups
11347952|NCT04203225|FG000|Participant Flow|Single LET|"One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes~LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic"
11347953|NCT04203225|FG001|Participant Flow|Triple LET|"Three applications of LET topical gel, one applied every 10 minutes~LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic"
11347954|NCT04203225|OG000|Outcome|Single LET|"One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes~LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic"
11347955|NCT04203225|OG001|Outcome|Triple LET|"Three applications of LET topical gel, one applied every 10 minutes~LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic"
11347956|NCT04203225|EG000|Reported Event|Single LET|"One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes~LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic"
11347957|NCT04203225|EG001|Reported Event|Triple LET|"Three applications of LET topical gel, one applied every 10 minutes~LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic"
11347958|NCT04234672|BG000|Baseline|TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg|TAK-831 5 X 100 mg tablets, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
11347959|NCT04234672|FG000|Participant Flow|TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg|TAK-831 5 X 100 mg tablets, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
11347960|NCT04234672|OG000|Outcome|TAK-831 500 mg + [14C]TAK-831 50 μg|TAK-831 5 X 100 mg tablets, orally, followed by [14C]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.
11347961|NCT04234672|OG000|Outcome|[14C]TAK-831 500 mg|[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
11347962|NCT04234672|OG000|Outcome|[14C]TAK-831 50 μg|[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
11347963|NCT04234672|OG000|Outcome|TAK-831 500 mg|TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
10858796|NCT00354744|OG000|Outcome|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
10858797|NCT00354744|OG000|Outcome|High_Risk_Rhabdomyosarcoma|Patients with parameningeal (without intracranial extension) and paraspinal tumors should receive chemotherapy beginning Week 1 and begin radiation therapy at Week 20. Weeks 1-6 vincristine sulfate (VCR) & irinotecan hydrochloride (IRIN), Weeks 7-34 vincristine sulfate (VCR), Cyclophosphamide (CPM) with MESNA, Doxorubicin hydrochloride (DOX), Etoposide (ETOP), Ifosfamide (IFOS) with MESNA. Weeks 35-54 vincristine sulfate (VCR), Dactinomycin (DACT) and Cyclophosphamide (CPM) with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
10858798|NCT00354744|EG000|Reported Event|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
10858799|NCT00354770|BG000|Baseline|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
10858800|NCT00354770|BG001|Baseline|Placebo|Placebo pills
10858801|NCT00354770|BG002|Baseline|Total|Total of all reporting groups
10858802|NCT00354770|FG000|Participant Flow|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
10858803|NCT00354770|FG001|Participant Flow|Placebo|Placebo pills
10858804|NCT00354770|OG000|Outcome|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
10858805|NCT00354770|OG001|Outcome|Placebo|Placebo pills
10858806|NCT00354770|EG000|Reported Event|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
10858807|NCT00354770|EG001|Reported Event|Placebo|Placebo pills
10858808|NCT00354887|BG000|Baseline|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
10858809|NCT00354887|FG000|Participant Flow|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
10858810|NCT00354887|OG000|Outcome|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
10858811|NCT00354887|EG000|Reported Event|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
10858812|NCT00354913|BG000|Baseline|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
10858813|NCT00354913|FG000|Participant Flow|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
10858814|NCT00354913|OG000|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
10858815|NCT00354913|EG000|Reported Event|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
10878954|NCT00454805|EG000|Reported Event|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
10878955|NCT00454805|EG001|Reported Event|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
10878956|NCT00454818|BG000|Baseline|Phase 1: MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
10878957|NCT00454818|BG001|Baseline|Phase 1: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
10878958|NCT00454818|BG002|Baseline|Phase 1: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
10878959|NCT00454818|BG003|Baseline|Phase 1: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
11347964|NCT04234672|OG001|Outcome|[14C]TAK-831 50 μg|[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
10878960|NCT00454818|BG004|Baseline|Phase 2: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
10858816|NCT00354978|BG000|Baseline|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
10858817|NCT00354978|FG000|Participant Flow|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
10858818|NCT00354978|OG000|Outcome|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
10858819|NCT00354978|EG000|Reported Event|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
10858820|NCT00355030|BG000|Baseline|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
10858821|NCT00355030|BG001|Baseline|Somatropin|0.05mg/kg/day subcutaneous somatropin only
10858822|NCT00355030|BG002|Baseline|Total|Total of all reporting groups
10858823|NCT00355030|FG000|Participant Flow|Somatropin and Leuprorelin: Experimental Arm 1|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
10858824|NCT00355030|FG001|Participant Flow|Somatropin: Experimental Arm 2|0.05mg/kg/day subcutaneous somatropin only
10858825|NCT00355030|OG000|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
10858826|NCT00355030|OG001|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
10858827|NCT00355030|EG000|Reported Event|Somatropin and Leuprorelin|Somatropin and leuprorelin n=46
10858828|NCT00355030|EG001|Reported Event|Somatropin|Somatropin n=45
10858829|NCT00355056|BG000|Baseline|Sham Procedure|Participants will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure).
10858830|NCT00355056|BG001|Baseline|PFO Device Closure|Participants will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
10858831|NCT00355056|BG002|Baseline|Total|Total of all reporting groups
10858832|NCT00355056|FG000|Participant Flow|Sham Procedure|Did not receive the closure device, and treated with the current standard of care medical treatment.
10858833|NCT00355056|FG001|Participant Flow|Patent Foramen Ovale (PFO) Device Closure|Patent foramen ovale (PFO) device Closure procedure using the AMPLATZER PFO Occluder device.
10858834|NCT00355056|OG000|Outcome|Sham Procedure|Did not receive the closure device, and treated with the current standard of care medical treatment.
10858835|NCT00355056|OG001|Outcome|PFO Device Closure|PFO device Closure procedure using the AMPLATZER PFO Occluder device.
10858836|NCT00355056|OG000|Outcome|PFO Device Closure|PFO device Closure procedure using the AMPLATZER PFO Occluder device.
10858837|NCT00355056|OG000|Outcome|Sham Procedure|Sham Procedure and treated only with current standard of care medical treatment.
10858838|NCT00355056|OG001|Outcome|PFO Device Closure|Patients in this arm received the AMPLATZER PFO Occluder device
10858839|NCT00355056|OG000|Outcome|PFO Closure|Device group subjects who had a Core Lab adjudicated TCD grade at Valsalva of less than or equal to 2 at 12-months.
10858840|NCT00355056|OG000|Outcome|PFO Closure|Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
10858841|NCT00355056|OG000|Outcome|PFO Device Closure|Patients in this arm received the AMPLATZER PFO Occluder device.
10858842|NCT00355056|OG001|Outcome|Sham Procedure|Sham Procedure and treated only with current standard of care medical treatment.
10858843|NCT00355056|EG000|Reported Event|PFO Device Closure|PFO device Closure procedure using the AMPLATZER PFO Occluder device.
10858844|NCT00355056|EG001|Reported Event|Sham Procedure|Did not receive the closure device, and treated with the current standard of care medical treatment.
10858845|NCT00355056|EG002|Reported Event|Optional PFO Closure|Subjects randomized to the sham arm and completed their 12-month follow up visit were given the option of PFO closure with the Amplatzer PFO Occluder.
10858846|NCT00355082|BG000|Baseline|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
10858847|NCT00355082|BG001|Baseline|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
10858848|NCT00355082|BG002|Baseline|Total|Total of all reporting groups
10858849|NCT00355082|FG000|Participant Flow|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day.
10858850|NCT00355082|FG001|Participant Flow|LTG XR, 250 mg|LTG XR, 250 mg/day
10858851|NCT00355082|FG002|Participant Flow|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
10858852|NCT00355082|OG000|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
10858853|NCT00355082|OG000|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
10858854|NCT00355082|OG001|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
10858855|NCT00355082|OG000|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
10858856|NCT00355082|OG001|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
10858857|NCT00355082|EG000|Reported Event|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
11347965|NCT04234672|OG002|Outcome|[14C]TAK-831 500 mg|[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
11347966|NCT04234672|EG000|Reported Event|TAK-831 500 mg|TAK-831 5 X 100 mg tablets, orally, once on Day 1 of Treatment Period 1.
11347967|NCT04234672|EG001|Reported Event|[14C]TAK-831 50 μg|[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
11347968|NCT04234672|EG002|Reported Event|[14C]TAK-831 500 mg|[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
11347969|NCT04223635|BG000|Baseline|Normal HF|Healthy matched participants with normal HF who received 200mg pexidartinib on Day 1 with 240 mL water. Participants fasted for at least 10h before pexidartinib dosing and continued to fast for at least 4h after pexidartinib administration.
11347970|NCT04223635|BG001|Baseline|Moderate HI|Participants with moderate HI who received 200mg pexidartinib on Day 1 with 240 mL water. Participants fasted for at least 10h before pexidartinib dosing and continued to fast for at least 4h after pexidartinib administration. Moderate hepatic impairment (HI) was assessed by National Cancer Institute - Organ Dysfunction Working Group (NCI-ODWG).
11347971|NCT04223635|BG002|Baseline|Total|Total of all reporting groups
11347972|NCT04223635|FG000|Participant Flow|Normal HF|Healthy matched participants with normal hepatic function (HF) who received 200mg pexidartinib on Day 1 with 240 mL water. Participants fasted for at least 10 hours(h) before pexidartinib dosing and continued to fast for at least 4h after pexidartinib administration.
11347973|NCT04223635|FG001|Participant Flow|Moderate HI|Participants with moderate HI who received 200mg pexidartinib on Day 1 with 240 mL water. Participants fasted for at least 10 hours(h) before pexidartinib dosing and continued to fast for at least 4h after pexidartinib administration. Moderate hepatic impairment (HI) was assessed by National Cancer Institute - Organ Dysfunction Working Group (NCI-ODWG).
11347974|NCT04223635|OG000|Outcome|Normal HF|Healthy matched participants with normal HF who received 200mg pexidartinib on Day 1 with 240 mL water. Participants fasted for at least 10h before pexidartinib dosing and continued to fast for at least 4h after pexidartinib administration.
11347975|NCT04223635|OG001|Outcome|Moderate HI|Participants with moderate HI who received 200mg pexidartinib on Day 1 with 240 mL water. Participants fasted for at least 10h before pexidartinib dosing and continued to fast for at least 4h after pexidartinib administration. Moderate hepatic impairment (HI) was assessed by National Cancer Institute - Organ Dysfunction Working Group (NCI-ODWG).
11347976|NCT04223635|EG000|Reported Event|Normal HF|Healthy matched participants with normal HF who received 200mg pexidartinib on Day 1 with 240 mL water. Participants fasted for at least 10h before pexidartinib dosing and continued to fast for at least 4h after pexidartinib administration.
11347977|NCT04223635|EG001|Reported Event|Moderate HI|Participants with moderate HI who received 200mg pexidartinib on Day 1 with 240 mL water. Participants fasted for at least 10h before pexidartinib dosing and continued to fast for at least 4h after pexidartinib administration. Moderate hepatic impairment (HI) was assessed by National Cancer Institute - Organ Dysfunction Working Group (NCI-ODWG).
11347978|NCT04214951|BG000|Baseline|Recombinant Human Thrombopoietin (Rh-TPO) Group|"Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10^9/L. The efficacy, safety, and patient/physician preference will be assessed.~Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days."
11347979|NCT04214951|BG001|Baseline|Eltrombopag Group|"Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10^9/L.The efficacy, safety, and patient/physician preference will be assessed.~Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks."
11347980|NCT04214951|BG002|Baseline|Total|Total of all reporting groups
11347981|NCT04214951|FG000|Participant Flow|Eltrombopag Group|"Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10^9/L.The efficacy, safety, and patient/physician preference will be assessed.~Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks."
11347982|NCT04214951|FG001|Participant Flow|Recombinant Human Thrombopoietin (Rh-TPO) Group|"Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10^9/L. The efficacy, safety, and patient/physician preference will be assessed.~Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days."
11347983|NCT04214951|OG000|Outcome|Eltrombopag Group|"Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10^9/L.The efficacy, safety, and patient/physician preference will be assessed.~Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks."
11347984|NCT04214951|OG001|Outcome|Recombinant Human Thrombopoietin (Rh-TPO) Group|"Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10^9/L. The efficacy, safety, and patient/physician preference will be assessed.~Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days."
11347985|NCT04214951|EG000|Reported Event|Eltrombopag Group|"Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10^9/L.The efficacy, safety, and patient/physician preference will be assessed.~Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks."
10858858|NCT00355082|EG001|Reported Event|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
10858859|NCT00355082|EG002|Reported Event|Continuation Phase: LTG XR, 300 mg|Treatment phase participants; LTG XR, 300 mg/day
10858860|NCT00355082|EG003|Reported Event|Continuation Phase: Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
10858861|NCT00355121|BG000|Baseline|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
10858862|NCT00355121|BG001|Baseline|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
10858863|NCT00355121|BG002|Baseline|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
10858864|NCT00355121|BG003|Baseline|Total|Total of all reporting groups
10858865|NCT00355121|FG000|Participant Flow|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
10858866|NCT00355121|FG001|Participant Flow|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
10858867|NCT00355121|FG002|Participant Flow|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
10858868|NCT00355121|OG000|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
10858869|NCT00355121|OG001|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
10858870|NCT00355121|OG002|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
10858871|NCT00355121|OG000|Outcome|Group 1: Menactra on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
10858872|NCT00355121|OG001|Outcome|Group 2: IPOL on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
11347986|NCT04214951|EG001|Reported Event|Recombinant Human Thrombopoietin (Rh-TPO) Group|"Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10^9/L. The efficacy, safety, and patient/physician preference will be assessed.~Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days."
10858873|NCT00355121|OG002|Outcome|Group 3: DAPTACEL on Day 30 (Visit 2)|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
10858874|NCT00355121|EG000|Reported Event|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
10858875|NCT00355121|EG001|Reported Event|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
10858876|NCT00355121|EG002|Reported Event|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
10858877|NCT00355134|BG000|Baseline|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
10858878|NCT00355134|BG001|Baseline|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
10858879|NCT00355134|BG002|Baseline|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
10858880|NCT00355134|BG003|Baseline|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
10858881|NCT00355134|BG004|Baseline|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
10858882|NCT00355134|BG005|Baseline|Total|Total of all reporting groups
10858883|NCT00355134|FG000|Participant Flow|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
10858884|NCT00355134|FG001|Participant Flow|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
10858885|NCT00355134|FG002|Participant Flow|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
10858886|NCT00355134|FG003|Participant Flow|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
10858887|NCT00355134|FG004|Participant Flow|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
10858888|NCT00355134|OG000|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
10858889|NCT00355134|OG001|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
10858890|NCT00355134|OG002|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
10858891|NCT00355134|EG000|Reported Event|Core: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
10858892|NCT00355134|EG001|Reported Event|Core: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase.
10858893|NCT00355134|EG002|Reported Event|Core: Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
10858894|NCT00355134|EG003|Reported Event|Extension: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
10858895|NCT00355134|EG004|Reported Event|Extension: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day in the Extension phase.
10858896|NCT00355147|BG000|Baseline|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
10858897|NCT00355147|BG001|Baseline|Attention Control Group|Received Phone Calls from Staff to Control for Attention
10858898|NCT00355147|BG002|Baseline|Total|Total of all reporting groups
10858899|NCT00355147|FG000|Participant Flow|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
10858900|NCT00355147|FG001|Participant Flow|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
10858901|NCT00355147|OG000|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
10858902|NCT00355147|OG001|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
10878961|NCT00454818|BG005|Baseline|Phase 2: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
11347987|NCT04234425|BG000|Baseline|Experimental Group|"18 high school students in a weight training class will be assigned to this experimental group and will receive the one-hour intervention twice weekly for 8 weeks.~Trauma-Informed Yoga: Trauma-Informed Yoga practice held within a high school weight training class"
11347988|NCT04234425|FG000|Participant Flow|Experimental Group|"18 high school students in a weight training class will be assigned to this experimental group and will receive the one-hour intervention twice weekly for 8 weeks.~Trauma-Informed Yoga: Trauma-Informed Yoga practice held within a high school weight training class"
11347989|NCT04234425|OG000|Outcome|Experimental Group-Midpoint Data (4 Weeks)|18 high school students in a weight training class (one student less than baseline due to attrition)
11347990|NCT04234425|OG001|Outcome|Experimental Group-Baseline Data|18 high school students in a weight training class
11347991|NCT04234425|OG000|Outcome|Experimental Group|"18 high school students in a weight training class will be assigned to this experimental group and will receive the one-hour intervention twice weekly for 8 weeks.~Trauma-Informed Yoga: Trauma-Informed Yoga practice held within a high school weight training class"
11347992|NCT04234425|EG000|Reported Event|Experimental Group|"18 high school students in a weight training class will be assigned to this experimental group and will receive the one-hour intervention twice weekly for 8 weeks.~Trauma-Informed Yoga: Trauma-Informed Yoga practice held within a high school weight training class"
11347993|NCT04232137|BG000|Baseline|Coffee Ceremony|Antenatal care patients will be told on their first antenatal care visit that a postpartum coffee ceremony will be organized for them and up to 4 relatives
11347994|NCT04232137|BG001|Baseline|NO Coffee Ceremony|Antenatal care patients will be told that they will NOT receive a postpartum coffee ceremony, as is the current status quo
11347995|NCT04232137|BG002|Baseline|Total|Total of all reporting groups
11347996|NCT04232137|FG000|Participant Flow|Coffee Ceremony|Antenatal care patients will be told on their first antenatal care visit that a postpartum coffee ceremony will be organized for them and up to 4 relatives
11347997|NCT04232137|FG001|Participant Flow|NO Coffee Ceremony|Antenatal care patients will be told that they will NOT receive a postpartum coffee ceremony, as is the current status quo
11347998|NCT04232137|OG000|Outcome|Coffee Ceremony|Antenatal care patients will be told on their first antenatal care visit that a postpartum coffee ceremony will be organized for them and up to 4 relatives
11347999|NCT04232137|OG001|Outcome|NO Coffee Ceremony|Antenatal care patients will be told that they will NOT receive a postpartum coffee ceremony, as is the current status quo
11348000|NCT04232137|EG000|Reported Event|Coffee Ceremony|Antenatal care patients will be told on their first antenatal care visit that a postpartum coffee ceremony will be organized for them and up to 4 relatives
11348001|NCT04232137|EG001|Reported Event|NO Coffee Ceremony|Antenatal care patients will be told that they will NOT receive a postpartum coffee ceremony, as is the current status quo
11348002|NCT04222699|BG000|Baseline|Intranasal Mupirocin and Topical Chlorhexidine|"Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.~Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.~Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria.~Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury."
11348003|NCT04222699|FG000|Participant Flow|Intranasal Mupirocin and Topical Chlorhexidine|"Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.~Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.~Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria.~Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury."
11348004|NCT04222699|OG000|Outcome|Intranasal Mupirocin and Topical Chlorhexidine|"Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.~Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.~Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria.~Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury."
11348005|NCT04222699|EG000|Reported Event|Intranasal Mupirocin and Topical Chlorhexidine|"Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.~Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.~Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria.~Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury."
11348006|NCT04208698|BG000|Baseline|Screening Period|Screening Period
11348007|NCT04208698|BG001|Baseline|CIN-102 Tablets Dose 1|"CIN-102 tablets by mouth twice daily for 14 days~CIN-102 Dose 1: Deuterated domperidone (deudomperidone)"
11348008|NCT04208698|BG002|Baseline|Placebo for CIN-102 Dose 1|"Placebo tablets by mouth twice daily for 14 days~Placebo for CIN-102: Placebo"
11348009|NCT04208698|BG003|Baseline|CIN-102 Dose 2|"CIN-102 tablets by mouth twice daily for 14 days~CIN-102 Dose 2: Deuterated domperidone (deudomperidone)"
11348010|NCT04208698|BG004|Baseline|Placebo for CIN-102 Dose 2|"Placebo tablets by mouth twice daily for 14 days~Placebo for CIN-102: Placebo"
11348011|NCT04208698|BG005|Baseline|Total|Total of all reporting groups
11348012|NCT04208698|FG000|Participant Flow|Screening Period|Screening Period
10976922|NCT00942825|BG001|Baseline|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
10976923|NCT00942825|BG002|Baseline|Total|Total of all reporting groups
11348013|NCT04208698|FG001|Participant Flow|CIN-102 Tablets Dose 1|"CIN-102 tablets by mouth twice daily for 14 days~CIN-102 Dose 1: Deuterated domperidone (deudomperidone)"
11348014|NCT04208698|FG002|Participant Flow|Placebo for CIN-102 Dose 1|"Placebo tablets by mouth twice daily for 14 days~Placebo for CIN-102: Placebo"
11348015|NCT04208698|FG003|Participant Flow|CIN-102 Dose 2|"CIN-102 tablets by mouth twice daily for 14 days~CIN-102 Dose 2: Deuterated domperidone (deudomperidone)"
10976924|NCT00942825|FG000|Participant Flow|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
10976925|NCT00942825|FG001|Participant Flow|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
11348016|NCT04208698|FG004|Participant Flow|Placebo for CIN-102 Dose 2|"Placebo tablets by mouth twice daily for 14 days~Placebo for CIN-102: Placebo"
11348017|NCT04208698|OG000|Outcome|CIN-102 Tablets Dose 1|"CIN-102 tablets by mouth twice daily for 14 days~CIN-102 Dose 1: Deuterated domperidone (deudomperidone)"
11348018|NCT04208698|OG001|Outcome|Placebo for CIN-102 Dose 1|"Placebo tablets by mouth twice daily for 14 days~Placebo for CIN-102: Placebo"
11348019|NCT04208698|OG002|Outcome|CIN-102 Dose 2|"CIN-102 tablets by mouth twice daily for 14 days~CIN-102 Dose 2: Deuterated domperidone (deudomperidone)"
11348020|NCT04208698|OG003|Outcome|Placebo for CIN-102 Dose 2|"Placebo tablets by mouth twice daily for 14 days~Placebo for CIN-102: Placebo"
11348021|NCT04208698|EG000|Reported Event|CIN-102 Tablets Dose 1|"CIN-102 tablets by mouth twice daily for 14 days~CIN-102 Dose 1: Deuterated domperidone (deudomperidone)"
11348022|NCT04208698|EG001|Reported Event|Placebo for CIN-102 Dose 1|"Placebo tablets by mouth twice daily for 14 days~Placebo for CIN-102: Placebo"
11348023|NCT04208698|EG002|Reported Event|CIN-102 Dose 2|"CIN-102 tablets by mouth twice daily for 14 days~CIN-102 Dose 2: Deuterated domperidone (deudomperidone)"
11348024|NCT04208698|EG003|Reported Event|Placebo for CIN-102 Dose 2|"Placebo tablets by mouth twice daily for 14 days~Placebo for CIN-102: Placebo"
11348025|NCT04206293|BG000|Baseline|Juvéderm® VOLITE Treated Zone|Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.
11348026|NCT04206293|FG000|Participant Flow|Juvéderm® VOLITE Treated Zone|Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.
11348027|NCT04206293|OG000|Outcome|Juvéderm® VOLITE Treated Zone|Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.
11348028|NCT04206293|OG001|Outcome|Non-Treated Zone|The not-treated zone of the same arm in same the participant served as a control.
11348029|NCT04206293|EG000|Reported Event|Juvéderm® VOLITE Treated Zone|Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.
11348030|NCT04228302|BG000|Baseline|EC5026 0.5 mg|Single 0.5 mg dose of oral EC5026
11348031|NCT04228302|BG001|Baseline|EC5026 2 mg|Single 2 mg dose of oral EC5026
11348032|NCT04228302|BG002|Baseline|EC5026 8 mg|Single 8 mg dose of oral EC5026
11348033|NCT04228302|BG003|Baseline|EC5026 16 mg|Single 16 mg dose of oral EC5026
11348034|NCT04228302|BG004|Baseline|EC5026 24 mg|Single 24 mg dose of oral EC5026
11348035|NCT04228302|BG005|Baseline|Placebo|Single dose of matching oral placebo
11348036|NCT04228302|BG006|Baseline|Total|Total of all reporting groups
11348037|NCT04228302|FG000|Participant Flow|EC5026 0.5 mg|Single 0.5 mg dose of oral EC5026
11348038|NCT04228302|FG001|Participant Flow|EC5026 2 mg|Single 2 mg dose of oral EC5026
11348039|NCT04228302|FG002|Participant Flow|EC5026 8 mg|Single 8 mg dose of oral EC5026
11348040|NCT04228302|FG003|Participant Flow|EC5026 16 mg|Single 16 mg dose of oral EC5026
11348041|NCT04228302|FG004|Participant Flow|EC5026 24 mg|Single 24 mg dose of oral EC5026
11348042|NCT04228302|FG005|Participant Flow|Placebo|Single dose of matching oral placebo
11348043|NCT04228302|OG000|Outcome|EC5026 0.5 mg|Single 0.5 mg dose of oral EC5026
11348044|NCT04228302|OG001|Outcome|EC5026 2 mg|Single 2 mg dose of oral EC5026
11348045|NCT04228302|OG002|Outcome|EC5026 8 mg|Single 8 mg dose of oral EC5026
11348046|NCT04228302|OG003|Outcome|EC5026 16 mg|Single 16 mg dose of oral EC5026
11348047|NCT04228302|OG004|Outcome|EC5026 24 mg|Single 24 mg dose of oral EC5026
11348048|NCT04228302|OG005|Outcome|Placebo|Single dose of matching oral placebo
11348049|NCT04228302|EG000|Reported Event|EC5026 0.5 mg|Single 0.5 mg dose of oral EC5026
11348050|NCT04228302|EG001|Reported Event|EC5026 2 mg|Single 2 mg dose of oral EC5026
11348051|NCT04228302|EG002|Reported Event|EC5026 8 mg|Single 8 mg dose of oral EC5026
10858903|NCT00355147|OG000|Outcome|Arm 1 Secondary Risk Factor Management|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Stroke Self Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
10858904|NCT00355147|OG000|Outcome|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
10858905|NCT00355147|OG001|Outcome|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
10858906|NCT00355147|OG000|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
10858907|NCT00355147|EG000|Reported Event|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
10858908|NCT00355147|EG001|Reported Event|Attention Control Group|Received Phone Calls from Staff to Control for Attention
10858909|NCT00355199|BG000|Baseline|R-HDS|"R-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting.~Rituximab-HDS: Rituximab-HDS"
10858910|NCT00355199|BG001|Baseline|R-CHOP|"Rituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).~Rituximab-CHOP: Rituximab-CHOP"
10858911|NCT00355199|BG002|Baseline|Total|Total of all reporting groups
10858912|NCT00355199|FG000|Participant Flow|R-HDS|R-HDS: 3 APO: first Doxorubicin at 50 mg/m2 iv, then at 75 mg/m2 iv days 14, 28; Vincristine 1.4 mg/m2 iv days 1,14,28; Prednisone p.o 40 mg/m2 days1-28). Subsequently:high-dose (hd) Cyclophosphamide 7 g/m2 iv, day 1+ Rituximab 375 mg/m2 iv days +3;+11, harvest of peripheral blood progenitor cells (PBPC); hd-Cytarabine 2 g/m2 iv bid for 6 days. Day 7:infusion 1.5-2x10^6 autologous CD34+ cells/kg, Rituximab 375 mg/m2 iv day+8;+16; hd-Etoposide 2.4 g/m2 iv day +1, Cisplatin 100 mg/m2 iv day+2; PBPC (2x10^6 CD34+ cells/Kg) reinfused following etoposide/cisplatin. ASCT conditioned with mitoxantrone 60 mg/m2 iv day -5 and melphalan 180 mg/m2 iv day -2 or BEAM (BCNU 300 mg/m2 iv day -6, Etoposide 200 mg/m2 iv days -5 to -2, Ara-C 200 mg/m2 iv every 12 h x8 doses, days from -5 to -2, Melphalan 140 mg/m2 iv day-1),supported by PBPC autograft day 0. Two Rituximab days +14;+24 after ASCT. Patients with initial bulky or residual lesions received IFRT within 2-3 months after chemotherapy program.
10858913|NCT00355199|FG001|Participant Flow|R-CHOP 14|Patients enrolled into the control arm R-CHOP (rituximab 375 mg/m2 i.v., cyclophosphamide 750 mg/m2 i.v., doxorubicin 50 mg/m2 i.v., vincristine 1.4 mg/m2 i.v. given on day 1 and 100 mg/d of prednisone p.o. on days 1-5), given every 14 days x 8 cycles. The neutropenic phase was supported by G-CSF (filgrastrim 5μg/kg s.c. daily or Pegfilgrastim s.c. given once on day +1 of each cycle). CNS prophylaxis with intrathecal chemotherapy (MTX, ARAC, steroids) was given to high risk patients who, at diagnosis, had infiltration of the bone marrow, testes, Waldeyer ring, cranial air sinuses (including nasal), salivary glands and epidural space. In R-CHOP, 33 patients (27%) received intrathecal prophylaxis. Patients with initial bulky or residual lesions received IFRT within 2-3 months after chemotherapy program.
10858914|NCT00355199|OG000|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
10858915|NCT00355199|OG001|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
10858916|NCT00355199|EG000|Reported Event|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
10858917|NCT00355199|EG001|Reported Event|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
10858918|NCT00355264|BG000|Baseline|Phenoptin|"In Part 1, subjects continued their usual treatment regimen.~In Part 2, subjects on non-registered formulations of BH4 at enrollment began Phenoptin treatment at approximately the same daily dose; subjects not receiving BH4 at enrollment began treatment at 5mg/kg/day Phenoptin. Half a dose was administered orally twice daily, to achieve a full dose/day.~In Part 3, subjects receives 10 mg/kg/day Phenoptin, administered orally twice for three weeks, followed by 20 mg/kg/day once daily for remaining 4 weeks.~In extension phase, subjects were offered the option to continue treatment with Phenoptin.~The mean Phenoptin dose received during the study was 9.1 mg/kg/day with a minimum of 1.9 mg/kg/day and a maximum of 21 mg/kg/day.~All 12 subjects participated in Part 1, Part 2 and Extension Phase. Subjects completed Part 2 are offered the option of participating in Part 3, Subjects who agreed to participate proceeded to Part 3. Among 12 subjects, 2 participated in Part 3."
10858919|NCT00355264|FG000|Participant Flow|Phenoptin|"In Part 1, subjects continued their usual treatment regimen.~In Part 2, subjects on non-registered formulations of Tetrahydrobiopterin (BH4) at enrollment began Phenoptin treatment at approximately the same daily dose; subjects not receiving BH4 at enrollment began treatment at 5mg/kg/day Phenoptin. Half of the dose was administered orally twice daily, to achieve a full dose per day.~In Part 3 (concurrent with Extension), subjects had the option of receiving 10 mg/kg/day Phenoptin administered orally twice daily for three weeks, followed by 20 mg/kg/day once daily for remaining 4 weeks.~In extension phase, subjects were offered the option to continue treatment with Phenoptin.~All 12 subjects participated in Part 1, Part 2 and Extension Phase. Subjects that completed Part 2 were offered the option of participating in Part 3. Among 12 subjects, 2 participated in Part 3 that took place concurrent with the Extension study."
10858920|NCT00355264|OG000|Outcome|All Subjects|"In Part 1, subjects continued their usual treatment regimen.~In Part 2, subjects on non-registered formulations of BH4 at enrollment began Phenoptin treatment at approximately the same daily dose; subjects not receiving BH4 at enrollment began treatment at 5mg/kg/day Phenoptin. Half a dose was administered orally twice daily, to achieve a full dose/day.~In Part 3, subjects receives 10 mg/kg/day Phenoptin, half a dose administered orally twice daily for three weeks, followed by 20 mg/kg/day once daily for remaining 4 weeks.~In extension phase, subjects were offered the option to continue treatment with Phenoptin.~All 12 subjects participated in Part 1, Part 2 and Extension Phase. Subjects completed Part 2 are offered the option of participating in Part 3, Subjects who agreed to participate proceeded to Part 3. Among 12 subjects, 2 participated in Part 3."
10858921|NCT00355264|OG001|Outcome|Subgroup: Subjects With Synthesis Enzymatic Defect|Subjects primary BH4 deficiency due to defects in the genes encoding the enzymes involved in BH4 biosynthesis, guanosine triphosphate (GTP) cyclohydrolase I (GCH1), 6-pyruvoyl-tetrahydropterin synthase (PTPS), and sepiapterin reductase (SR).
10858922|NCT00355264|OG002|Outcome|Subgroup: Subjects With Recycling Enzyme Defect|Subjects with BH4 deficiency due to defects in the genes encoding the enzymes involved in BH4 recycling, pterin-4a-carbinolamine dehydratase (PCD) and dihydropteridine reductase (DHPR).
10858923|NCT00355264|OG000|Outcome|All Subjects|"In Part 1, subjects continued their usual treatment regimen.~In Part 2, subjects on non-registered formulations of BH4 at enrollment began Phenoptin treatment at approximately the same daily dose; subjects not receiving BH4 at enrollment began treatment at 5mg/kg/day Phenoptin. Half a dose was administered orally twice daily, to achieve a full dose/day.~In Part 3, subjects receives 10 mg/kg/day Phenoptin, administered orally twice for three weeks, followed by 20 mg/kg/day once daily for remaining 4 weeks.~In extension phase, subjects were offered the option to continue treatment with Phenoptin, either resumed with previously taken BH4 (tetrahydrobiopterin) formulations.~All 12 subjects participated in Part 1, Part 2 and Extension Phase. Subjects completed Part 2 are offered the option of participating in Part 3, Subjects who agreed to participate proceeded to Part 3. Among 12 subjects, 2 participated in Part 3."
10858924|NCT00355264|OG000|Outcome|Phenoptin|"In Part 1, subjects continued their usual treatment regimen.~In Part 2, subjects on non-registered formulations of BH4 at enrollment began Phenoptin treatment at approximately the same daily dose; subjects not receiving BH4 at enrollment began treatment at 5mg/kg/day Phenoptin. Half a dose was administered orally twice daily, to achieve a full dose/day.~In Part 3, subjects receives 10 mg/kg/day Phenoptin, administered orally twice for three weeks, followed by 20 mg/kg/day once daily for remaining 4 weeks.~In extension phase, subjects were offered the option to continue treatment with Phenoptin.~All 12 subjects participated in Part 1, Part 2 and Extension Phase. Subjects completed Part 2 are offered the option of participating in Part 3, Subjects who agreed to participate proceeded to Part 3. Among 12 subjects, 2 participated in Part 3."
10858925|NCT00355264|OG000|Outcome|Phenoptin|"In Part 1, subjects continued their usual treatment regimen.~In Part 2, subjects on non-registered formulations of BH4 at enrollment began Phenoptin treatment at approximately the same daily dose; subjects not receiving BH4 at enrollment began treatment at 5mg/kg/day Phenoptin. Half a dose was administered orally twice daily, to achieve a full dose/day.~In Part 3, subjects receives 10 mg/kg/day Phenoptin, administered orally twice for three weeks, followed by 20 mg/kg/day once daily for remaining 4 weeks.~In extension phase, subjects were offered the option to continue treatment with Phenoptin.~All 12 subjects participated in Part 1, Part 2 and Extension Phase. Subjects completed Part 2 were offered the option of participating in Part 3, Subjects who agreed to participate proceeded to Part 3. Among 12 subjects, 2 participated in Part 3."
10858926|NCT00355264|EG000|Reported Event|Phenoptin|"In Part 1, subjects continued their usual treatment regimen.~In Part 2, subjects on non-registered formulations of BH4 at enrollment began Phenoptin treatment at approximately the same daily dose; subjects not receiving BH4 at enrollment began treatment at 5mg/kg/day Phenoptin. Half a dose was administered orally twice daily, to achieve a full dose/day.~In Part 3, subjects receives 10 mg/kg/day Phenoptin, administered orally twice for three weeks, followed by 20 mg/kg/day once daily for remaining 4 weeks.~In extension phase, subjects were offered the option to continue treatment with Phenoptin, either resumed with previously taken BH4 (tetrahydrobiopterin) formulations.~All 12 subjects participated in Part 1, Part 2 and Extension Phase. Subjects completed Part 2 are offered the option of participating in Part 3, Subjects who agreed to participate proceeded to Part 3. Among 12 subjects, 2 participated in Part 3."
10858927|NCT00355342|BG000|Baseline|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
10858928|NCT00355342|BG001|Baseline|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
10858929|NCT00355342|BG002|Baseline|Total|Total of all reporting groups
10858930|NCT00355342|FG000|Participant Flow|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline.
10858931|NCT00355342|FG001|Participant Flow|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
10858932|NCT00355342|OG000|Outcome|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
11348052|NCT04228302|EG003|Reported Event|EC5026 16 mg|Single 16 mg dose of oral EC5026
10976926|NCT00942825|OG000|Outcome|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
10858933|NCT00355342|OG001|Outcome|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
10858934|NCT00355342|EG000|Reported Event|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
10858935|NCT00355342|EG001|Reported Event|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
10858936|NCT00355368|BG000|Baseline|Succinylcholine|1mg/kg
10858937|NCT00355368|BG001|Baseline|Rocuronium|0.6mg/kg
10858938|NCT00355368|BG002|Baseline|Total|Total of all reporting groups
10858939|NCT00355368|FG000|Participant Flow|Succinylcholine|1mg/kg
10858940|NCT00355368|FG001|Participant Flow|Rocuronium|0.6mg/kg
10858941|NCT00355368|OG000|Outcome|Succinylcholine|
10858942|NCT00355368|OG001|Outcome|Rocuronium|
10858943|NCT00355368|EG000|Reported Event|Succinylcholine|1mg/kg
10858944|NCT00355368|EG001|Reported Event|Rocuronium|0.6mg/kg
10858945|NCT00355394|BG000|Baseline|Placebo|Placebo group received standard care including IVF but not metoclopramide.
10858946|NCT00355394|BG001|Baseline|Metoclopramide|Metoclopramide group received standard care including IVF AND metoclopramide.
10858947|NCT00355394|BG002|Baseline|Total|Total of all reporting groups
10858948|NCT00355394|FG000|Participant Flow|Placebo|Placebo group received standard care including IVF but not metoclopramide.
10858949|NCT00355394|FG001|Participant Flow|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
10858950|NCT00355394|OG000|Outcome|Placebo|Placebo
10858951|NCT00355394|OG001|Outcome|Metoclopramide|Metoclopramide
10858952|NCT00355394|OG000|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
10858953|NCT00355394|OG001|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
10858954|NCT00355394|EG000|Reported Event|Placebo|Placebo group received standard care including IVF but not metoclopramide.
10858955|NCT00355394|EG001|Reported Event|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
10858956|NCT00355472|BG000|Baseline|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
10858957|NCT00355472|FG000|Participant Flow|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CC chemokine 4 receptor (CCR4) positive Adult T-Cell Leukemia-Lymphoma (ATL) or CCR4 positive Peripheral T-Cell Lymphoma (PTCL)
10858958|NCT00355472|OG000|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
10858959|NCT00355472|OG000|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
10858960|NCT00355472|OG001|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
10858961|NCT00355472|OG002|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
10858962|NCT00355472|OG003|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
10858963|NCT00355472|OG000|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL.
10858964|NCT00355472|EG000|Reported Event|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
10858965|NCT00355472|EG001|Reported Event|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
10858966|NCT00355472|EG002|Reported Event|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
10858967|NCT00355472|EG003|Reported Event|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
10858968|NCT00355615|BG000|Baseline|Rosuva 5|rosuvastatin 5 mg
10858969|NCT00355615|BG001|Baseline|Rosuva 10|rosuvastatin 10 mg
10858970|NCT00355615|BG002|Baseline|Rosuva 20|rosuvastatin 20 mg
10858971|NCT00355615|BG003|Baseline|Placebo|placebo
10858972|NCT00355615|BG004|Baseline|Total|Total of all reporting groups
10858973|NCT00355615|FG000|Participant Flow|Rosuva 5|rosuvastatin 5 mg
10858974|NCT00355615|FG001|Participant Flow|Rosuva 10|rosuvastatin 10 mg
10858975|NCT00355615|FG002|Participant Flow|Rosuva 20|rosuvastatin 20 mg
10858976|NCT00355615|FG003|Participant Flow|Placebo|placebo
10858977|NCT00355615|FG004|Participant Flow|Rosuva ol|rosuvastatin open label
10858978|NCT00355615|OG000|Outcome|Rosuva 5|rosuvastatin 5 mg
10858979|NCT00355615|OG001|Outcome|Rosuva 10|rosuvastatin 10 mg
10858980|NCT00355615|OG002|Outcome|Rosuva 20|rosuvastatin 20 mg
10858981|NCT00355615|OG003|Outcome|Placebo|placebo
10858982|NCT00355615|EG000|Reported Event|Rosuva 5|rosuvastatin 5 mg
10858983|NCT00355615|EG001|Reported Event|Rosuva 10|rosuvastatin 10 mg
10858984|NCT00355615|EG002|Reported Event|Rosuva 20|rosuvastatin 20 mg
10858985|NCT00355615|EG003|Reported Event|Placebo|placebo
10858986|NCT00355615|EG004|Reported Event|Rosuva ol|rosuvastatin open label
10858987|NCT00355706|BG000|Baseline|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
10858988|NCT00355706|BG001|Baseline|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
10858989|NCT00355706|BG002|Baseline|Total|Total of all reporting groups
10858990|NCT00355706|FG000|Participant Flow|Group I - Without Steroids|Group I - Thoracic medial branch blocks with local anesthetics
11348053|NCT04228302|EG004|Reported Event|EC5026 24 mg|Single 24 mg dose of oral EC5026
11348054|NCT04228302|EG005|Reported Event|Placebo|Single dose of matching oral placebo
11348055|NCT04227119|BG000|Baseline|Irrigated Ablation Catheter and Balloon Tipped PA Catheter|Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure) and a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).
11348056|NCT04227119|FG000|Participant Flow|Irrigated Ablation Catheter and Balloon Tipped PA Catheter|"Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure) and a 5 French (5F) sized balloon tipped pulmonary artery (PA) catheter (for study purposes only).~The catheter will be positioned in either the left or right side of the heart."
11348057|NCT04227119|OG000|Outcome|Irrigated Ablation Catheter|Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure).
11348058|NCT04227119|OG001|Outcome|Balloon Tipped PA Catheter|Participants undergoing cardiac ablation had cardiac pressures measured with a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).
11348059|NCT04227119|EG000|Reported Event|Irrigated Ablation Catheter|Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure).
11348060|NCT04227119|EG001|Reported Event|Balloon Tipped PA Catheter|Participants undergoing cardiac ablation had cardiac pressures measured with a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).
11348061|NCT04224753|BG000|Baseline|INVSENSOR00027 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.~INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject."
11348062|NCT04224753|FG000|Participant Flow|INVSENSOR00027 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.~INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject."
11348063|NCT04224753|OG000|Outcome|INVSENSOR00027 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.~INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject."
11348064|NCT04224753|EG000|Reported Event|INVSENSOR00027 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.~INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject."
11348065|NCT04218799|BG000|Baseline|Intranasal Mupirocin and Topical Chlorhexidine|Intranasal Mupirocin and Topical Chlorhexidine: Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
11348066|NCT04218799|FG000|Participant Flow|Intranasal Mupirocin and Topical Chlorhexidine|Intranasal Mupirocin and Topical Chlorhexidine: Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
11348067|NCT04218799|OG000|Outcome|Intranasal Mupirocin and Topical Chlorhexidine|Intranasal Mupirocin and Topical Chlorhexidine: Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
11348068|NCT04218799|EG000|Reported Event|Intranasal Mupirocin and Topical Chlorhexidine|Intranasal Mupirocin and Topical Chlorhexidine: Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
11348069|NCT04204057|BG000|Baseline|Tenalisib|"Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles~Tenalisib: Tenalisib 800 mg BID, Orally"
11348070|NCT04204057|FG000|Participant Flow|Tenalisib|"Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles~Tenalisib: Tenalisib 800 mg BID, Orally"
11348071|NCT04204057|OG000|Outcome|Tenalisib|"Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles~Tenalisib: Tenalisib 800 mg BID, Orally"
11348072|NCT04204057|EG000|Reported Event|Tenalisib|"Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles~Tenalisib: Tenalisib 800 mg BID, Orally"
11348073|NCT04195594|BG000|Baseline|Nic's Keto Diet|Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
11348074|NCT04195594|FG000|Participant Flow|Nic's Keto Diet|Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
11348075|NCT04195594|OG000|Outcome|Nic's Keto Diet|Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
11348076|NCT04195594|EG000|Reported Event|Nic's Keto Diet|Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
11348077|NCT04223687|BG000|Baseline|Neutral Label|Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
11348078|NCT04223687|BG001|Baseline|Sugar-Sweetened Beverage Warning Label|Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
11348079|NCT04223687|BG002|Baseline|Total|Total of all reporting groups
11348080|NCT04223687|FG000|Participant Flow|Neutral Label|Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
11348081|NCT04223687|FG001|Participant Flow|Sugar-Sweetened Beverage Warning Label|Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
11348082|NCT04223687|OG000|Outcome|Neutral Label|Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
11348083|NCT04223687|OG001|Outcome|Sugar-Sweetened Beverage Warning Label|Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
11348084|NCT04223687|EG000|Reported Event|Sugar-Sweetened Beverage Warning Label|Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
11348085|NCT04223687|EG001|Reported Event|Neutral Label|Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
11348086|NCT04223232|BG000|Baseline|MD1003|"radiolabeled 14C MD1003 (High Dose Biotin) 100mg~[14C]-MD1003: single oral dose of 100mg [14C]-MD1003"
11348087|NCT04223232|FG000|Participant Flow|MD1003|"radiolabeled 14C MD1003 (High Dose Biotin) 100mg~[14C]-MD1003: single oral dose of 100mg [14C]-MD1003"
11348088|NCT04223232|OG000|Outcome|MD1003|"radiolabeled 14C MD1003 (High Dose Biotin) 100mg~[14C]-MD1003: single oral dose of 100mg [14C]-MD1003"
11348089|NCT04223232|EG000|Reported Event|MD1003|"radiolabeled 14C MD1003 (High Dose Biotin) 100mg~[14C]-MD1003: single oral dose of 100mg [14C]-MD1003"
11348090|NCT04189224|BG000|Baseline|All Participants|Subjects that wore either Test or Control lens in either first or second period of the study.
11348091|NCT04189224|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.
11348092|NCT04189224|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.
11348093|NCT04189224|OG000|Outcome|Test (Senofilcon A)|Subjects that wore the Test lens in either the first or second period of the study.
11348094|NCT04189224|OG001|Outcome|Control (Etafilcon A)|Subjects that wore the Control lens in either the first or second period of the study.
11348095|NCT04189224|EG000|Reported Event|Test|Subjects that wore the Test lens in either the first or second period of the study.
11348096|NCT04189224|EG001|Reported Event|Control|Subjects that wore the Control lens in either the first or second period of the study.
11348097|NCT04214600|BG000|Baseline|Cognitive Behavioral Therapy|"This group will receive four CBT sessions twice a month for two months~Cognitive Behavioral Therapy (CBT): Patients in the CBT intervention group will receive four educational sessions for 30-45 minutes on one to one basis every two weeks during patients' regular follow up visits. The visits will be scheduled depending on the patient's availability. The sessions will be delivered by a trained physician and will include:~Session 1: Dealing with thoughts of sadness and depression Session 2: Dealing with thoughts of anxiety and stress Session 3: Dealing with anger Session 4: Enhancement of coping and problem-solving skills"
11348098|NCT04214600|BG001|Baseline|Control|This group will be scheduled the same number of visits as a follow up for diabetes.
11348099|NCT04214600|BG002|Baseline|Total|Total of all reporting groups
11348100|NCT04214600|FG000|Participant Flow|Cognitive Behavioral Therapy|"This group will receive four CBT sessions twice a month for two months~Cognitive Behavioral Therapy (CBT): Patients in the CBT intervention group will receive four educational sessions for 30-45 minutes on one to one basis every two weeks during patients' regular follow up visits. The visits will be scheduled depending on the patient's availability. The sessions will be delivered by a trained physician. The sessions will include:~Session 1: Dealing with thoughts of sadness and depression Session 2: Dealing with thoughts of anxiety and stress Session 3: Dealing with anger Session 4: Enhancement of coping and problem-solving skills"
11348101|NCT04214600|FG001|Participant Flow|Control|This group will be scheduled the same number of visits as a follow up for diabetes
11348102|NCT04214600|OG000|Outcome|CBT Group|Participants received four Cognitive Behavioral Therapy sessions and diabetes education
11348103|NCT04214600|OG001|Outcome|Control Group|Participants received diabetes education only
11348104|NCT04214600|OG001|Outcome|Control Group|Participants received four diabetes education only
11348105|NCT04214600|EG000|Reported Event|CBT Group|Participants received four CBT sessions and diabetes education
11348106|NCT04214600|EG001|Reported Event|Control Group|Participants received diabetes education only
11348107|NCT04202497|BG000|Baseline|Baseline [18F]MNI-1054|[18F]MNI-1054 up to 10 mCi, PET radiotracer injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348108|NCT04202497|FG000|Participant Flow|Baseline [18F]MNI-1054|[18F]MNI-1054 up to 10 mCi, PET radiotracer injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348109|NCT04202497|FG001|Participant Flow|TAK-418 1.5 mg|TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348110|NCT04202497|FG002|Participant Flow|TAK-418 10 mg|TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
10858991|NCT00355706|FG001|Participant Flow|Group II - With Steroids|Group II - Thoracic medial branch blocks with bupivacaine and steroid
10858992|NCT00355706|OG000|Outcome|Group I Without Steroids|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)
10858993|NCT00355706|OG001|Outcome|Group II With Steroid|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)
10858994|NCT00355706|OG000|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
10858995|NCT00355706|OG001|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
10858996|NCT00355706|EG000|Reported Event|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
10858997|NCT00355706|EG001|Reported Event|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
10858998|NCT00355784|BG000|Baseline|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
10858999|NCT00355784|BG001|Baseline|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
10859000|NCT00355784|BG002|Baseline|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone.
10859001|NCT00355784|BG003|Baseline|Total|Total of all reporting groups
10859002|NCT00355784|FG000|Participant Flow|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
10859003|NCT00355784|FG001|Participant Flow|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
10859004|NCT00355784|FG002|Participant Flow|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
10859005|NCT00355784|OG000|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
10859006|NCT00355784|OG001|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
10859007|NCT00355784|OG002|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
10859008|NCT00355784|OG002|Outcome|High Growth Hormone Treatment (High-GHT)|
10859009|NCT00355784|EG000|Reported Event|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
10859010|NCT00355784|EG001|Reported Event|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
10859011|NCT00355784|EG002|Reported Event|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
10859012|NCT00355797|BG000|Baseline|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
10859013|NCT00355797|BG001|Baseline|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
10859014|NCT00355797|BG002|Baseline|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
10859015|NCT00355797|BG003|Baseline|Total|Total of all reporting groups
10859016|NCT00355797|FG000|Participant Flow|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
10859017|NCT00355797|FG001|Participant Flow|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
10859018|NCT00355797|FG002|Participant Flow|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
10859019|NCT00355797|OG000|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
10859020|NCT00355797|OG001|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
10859021|NCT00355797|OG002|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
10859022|NCT00355797|EG000|Reported Event|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
10859023|NCT00355797|EG001|Reported Event|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
10859024|NCT00355797|EG002|Reported Event|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
10859025|NCT00355914|BG000|Baseline|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
10859026|NCT00355914|BG001|Baseline|Group II With Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic with steroids
10859027|NCT00355914|BG002|Baseline|Total|Total of all reporting groups
10859028|NCT00355914|FG000|Participant Flow|Group 1 Without Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
10859029|NCT00355914|FG001|Participant Flow|Group II With Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and Steroids (0.15 mg of non-particulate betamethasone)
10859030|NCT00355914|OG000|Outcome|Group I|Local anesthetic without steroids
10859031|NCT00355914|OG001|Outcome|Group II|Local anesthetic with steroids
10859032|NCT00355914|OG000|Outcome|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
10859033|NCT00355914|OG001|Outcome|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
10859034|NCT00355914|EG000|Reported Event|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
10859035|NCT00355914|EG001|Reported Event|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
10859036|NCT00356031|BG000|Baseline|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
10859037|NCT00356031|FG000|Participant Flow|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
10859038|NCT00356031|OG000|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
10859039|NCT00356031|OG000|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy."
10859040|NCT00356031|OG000|Outcome|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
10878962|NCT00454818|BG006|Baseline|Phase 2: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
10878963|NCT00454818|BG007|Baseline|Phase 2: Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
10878964|NCT00454818|BG008|Baseline|Total|Total of all reporting groups
10859041|NCT00356031|EG000|Reported Event|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
10859042|NCT00356057|BG000|Baseline|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
10859043|NCT00356057|BG001|Baseline|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
10859044|NCT00356057|BG002|Baseline|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
10859045|NCT00356057|BG003|Baseline|Total|Total of all reporting groups
10859046|NCT00356057|FG000|Participant Flow|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
10859047|NCT00356057|FG001|Participant Flow|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
10859048|NCT00356057|FG002|Participant Flow|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
10859049|NCT00356057|OG000|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
10859050|NCT00356057|OG001|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
10859051|NCT00356057|OG002|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
10859052|NCT00356057|OG000|Outcome|Protos DR/CLS System|Protos DR/CLS (biV pacing with CLS rate adaptation)
10859053|NCT00356057|OG000|Outcome|Stratos LV System|Stratos LV (biV or RV pacing groups with accelerometer based rate adaptation)
10859054|NCT00356057|OG000|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
10859055|NCT00356057|OG001|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
10859056|NCT00356057|OG002|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
10859057|NCT00356057|OG000|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with CLS rate adaptation (Protos CLS device)
10859058|NCT00356057|EG000|Reported Event|All Groups|
10859059|NCT00356122|BG000|Baseline|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
10859060|NCT00356122|FG000|Participant Flow|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
10859061|NCT00356122|OG000|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
10859062|NCT00356122|EG000|Reported Event|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
10859063|NCT00356135|BG000|Baseline|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
10845658|NCT00268437|OG000|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
10859064|NCT00356135|BG001|Baseline|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
10859065|NCT00356135|BG002|Baseline|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
10859066|NCT00356135|BG003|Baseline|Total|Total of all reporting groups
10859067|NCT00356135|FG000|Participant Flow|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
10859068|NCT00356135|FG001|Participant Flow|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
10859069|NCT00356135|FG002|Participant Flow|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
10859070|NCT00356135|OG000|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
10859071|NCT00356135|OG001|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
10859072|NCT00356135|OG002|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
10859073|NCT00356135|OG000|Outcome|Clopidogrel Use|Patients with clopidogrel use at the time of qualifying ACS event.
10859074|NCT00356135|OG001|Outcome|No Clopidogrel Use|Patients with no clopidogrel use at the time of qualifying ACS event.
10859075|NCT00356135|EG000|Reported Event|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
10859076|NCT00356135|EG001|Reported Event|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
10859077|NCT00356135|EG002|Reported Event|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
10859078|NCT00356148|BG000|Baseline|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
10859079|NCT00356148|BG001|Baseline|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
10859080|NCT00356148|BG002|Baseline|Total|Total of all reporting groups
10859081|NCT00356148|FG000|Participant Flow|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
10859082|NCT00356148|FG001|Participant Flow|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
10859083|NCT00356148|OG000|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
10859084|NCT00356148|OG001|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receive antibiotic prophylaxis
10859085|NCT00356148|OG001|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receiving antibiotic prophylaxis
10859086|NCT00356148|EG000|Reported Event|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
10859087|NCT00356148|EG001|Reported Event|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
10859088|NCT00356200|BG000|Baseline|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
10859089|NCT00356200|BG001|Baseline|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
10859090|NCT00356200|BG002|Baseline|Total|Total of all reporting groups
10859091|NCT00356200|FG000|Participant Flow|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
10859092|NCT00356200|FG001|Participant Flow|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
10859093|NCT00356200|OG000|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|lesion receiving 10 ug/ml Fluphenazine decanoate (Cohort 1)
10859094|NCT00356200|OG001|Outcome|Cohort 1, Placebo Treated Lesion|lesion treated with placebo (Cohort 1)
10859095|NCT00356200|OG002|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|lesion receiving 100 ug/ml Fluphenazine decanoate (Cohort 2)
10859096|NCT00356200|OG003|Outcome|Cohort 2, Placebo Treated Lesion|lesion treated with placebo (Cohort 2)
10859097|NCT00356200|OG000|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|Cohort 1 10 ug/ml Fluphenazine decanoate treated lesion
10859098|NCT00356200|OG001|Outcome|Cohort 1, Placebo Treated Lesion|Cohort 1 lesion treated with placebo
10859099|NCT00356200|OG002|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|Cohort 2 100 ug/ml Fluphenazine decanoate treated lesion
10859100|NCT00356200|OG003|Outcome|Cohort 2, Placebo Treated Lesion|Cohort 2 lesion treated with placebo
10859101|NCT00356200|EG000|Reported Event|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
10859102|NCT00356200|EG001|Reported Event|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
10859103|NCT00356265|BG000|Baseline|Chronic Kidney Disease|Procedure: Regional phenylephrine arterial infusion
10859104|NCT00356265|BG001|Baseline|Hypertension Group|Procedure: Regional phenylephrine arterial infusion
10859105|NCT00356265|BG002|Baseline|Normotensive Group|Procedure: Regional phenylephrine arterial infusion
10859106|NCT00356265|BG003|Baseline|Total|Total of all reporting groups
10859107|NCT00356265|FG000|Participant Flow|Chronic Kidney Disease (CKD)|Procedure: Regional phenylephrine arterial infusion
10859108|NCT00356265|FG001|Participant Flow|Hypertension Group|Procedure: Regional phenylephrine arterial infusion
10859109|NCT00356265|FG002|Participant Flow|Normotensive Group|Procedure: Regional phenylephrine arterial infusion
10859110|NCT00356265|OG000|Outcome|Chronic Kidney Disease|Procedure: Regional phenylephrine arterial infusion
10859111|NCT00356265|OG001|Outcome|Normotensive Group|
10859112|NCT00356265|OG001|Outcome|Hypertension Group|Procedure: Regional phenylephrine arterial infusion
10859113|NCT00356265|OG002|Outcome|Normotensive Group|Procedure: Regional phenylephrine arterial infusion
10859114|NCT00356265|EG000|Reported Event|Chronic Kidney Disease|Procedure: Regional phenylephrine arterial infusion
10859115|NCT00356265|EG001|Reported Event|Hypertension Group|Procedure: Regional phenylephrine arterial infusion
10859116|NCT00356265|EG002|Reported Event|Normotensive Group|Procedure: Regional phenylephrine arterial infusion
10859117|NCT00356278|BG000|Baseline|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
10859118|NCT00356278|BG001|Baseline|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
10859119|NCT00356278|BG002|Baseline|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
10859120|NCT00356278|BG003|Baseline|Total|Total of all reporting groups
10859121|NCT00356278|FG000|Participant Flow|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
10859122|NCT00356278|FG001|Participant Flow|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
10859123|NCT00356278|FG002|Participant Flow|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
10859124|NCT00356278|OG000|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
10859125|NCT00356278|OG001|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
10859126|NCT00356278|OG002|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
10859127|NCT00356278|EG000|Reported Event|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
10859128|NCT00356278|EG001|Reported Event|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
10859129|NCT00356278|EG002|Reported Event|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
10859130|NCT00356304|BG000|Baseline|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
10859131|NCT00356304|BG001|Baseline|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
10859132|NCT00356304|BG002|Baseline|Total|Total of all reporting groups
10859133|NCT00356304|FG000|Participant Flow|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
10859134|NCT00356304|FG001|Participant Flow|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
10859135|NCT00356304|OG000|Outcome|Motivational Enhancement Therapy for Antidepressants|
10859136|NCT00356304|OG001|Outcome|Treatment as Usual|
10859137|NCT00356304|EG000|Reported Event|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
10859138|NCT00356304|EG001|Reported Event|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
10859139|NCT00356369|BG000|Baseline|Nimenrix Group|Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.
10859140|NCT00356369|BG001|Baseline|Mencevax Group|Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
10859141|NCT00356369|BG002|Baseline|Total|Total of all reporting groups
10859142|NCT00356369|FG000|Participant Flow|Nimenrix Group|Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.
10859143|NCT00356369|FG001|Participant Flow|Mencevax Group|Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
10859144|NCT00356369|OG000|Outcome|Nimenrix Group|Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.
10859145|NCT00356369|OG001|Outcome|Mencevax Group|Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
10859146|NCT00356369|EG000|Reported Event|Nimenrix Group|Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.
10859147|NCT00356369|EG001|Reported Event|Mencevax Group|Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
10859148|NCT00356408|BG000|Baseline|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
10859149|NCT00356408|BG001|Baseline|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
10859150|NCT00356408|BG002|Baseline|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
10859151|NCT00356408|BG003|Baseline|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
10859152|NCT00356408|BG004|Baseline|Total|Total of all reporting groups
10859153|NCT00356408|FG000|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
10859154|NCT00356408|OG000|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
10859155|NCT00356408|OG001|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
10859156|NCT00356408|OG002|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
10859157|NCT00356408|OG003|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
10859158|NCT00356408|EG000|Reported Event|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
10859159|NCT00356408|EG001|Reported Event|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
10859160|NCT00356408|EG002|Reported Event|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
10859161|NCT00356408|EG003|Reported Event|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
10859162|NCT00356408|EG004|Reported Event|CDP870 400 mg (Overall)|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
10859163|NCT00356434|BG000|Baseline|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859164|NCT00356434|BG001|Baseline|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859165|NCT00356434|BG002|Baseline|Total|Total of all reporting groups
10859166|NCT00356434|FG000|Participant Flow|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859167|NCT00356434|FG001|Participant Flow|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859168|NCT00356434|OG000|Outcome|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859169|NCT00356434|OG001|Outcome|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859170|NCT00356434|OG000|Outcome|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859171|NCT00356434|EG000|Reported Event|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859172|NCT00356434|EG001|Reported Event|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
10859173|NCT00356525|BG000|Baseline|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
10859174|NCT00356525|BG001|Baseline|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
10859175|NCT00356525|BG002|Baseline|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
10859176|NCT00356525|BG003|Baseline|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
10859177|NCT00356525|BG004|Baseline|Total|Total of all reporting groups
10859178|NCT00356525|FG000|Participant Flow|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
10859179|NCT00356525|FG001|Participant Flow|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
10859180|NCT00356525|FG002|Participant Flow|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
10859181|NCT00356525|FG003|Participant Flow|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
10859182|NCT00356525|OG000|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
10859183|NCT00356525|OG001|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
10859184|NCT00356525|OG002|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
10859185|NCT00356525|OG003|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
10859186|NCT00356525|EG000|Reported Event|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
10859187|NCT00356525|EG001|Reported Event|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
10859188|NCT00356525|EG002|Reported Event|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
10859189|NCT00356525|EG003|Reported Event|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
10859190|NCT00356590|BG000|Baseline|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
10859191|NCT00356590|FG000|Participant Flow|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
10859192|NCT00356590|OG000|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
10859193|NCT00356590|EG000|Reported Event|Enbrel|
10859194|NCT00356603|BG000|Baseline|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859195|NCT00356603|BG001|Baseline|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859196|NCT00356603|BG002|Baseline|Total|Total of all reporting groups
10859197|NCT00356603|FG000|Participant Flow|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 milligrams (mg) kit product (0.5 milliliter [mL] containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859198|NCT00356603|FG001|Participant Flow|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859199|NCT00356603|OG000|Outcome|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859200|NCT00356603|OG001|Outcome|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859201|NCT00356603|OG002|Outcome|Migraine + Cluster Headache|Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859202|NCT00356603|EG000|Reported Event|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859203|NCT00356603|EG001|Reported Event|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859204|NCT00356603|EG002|Reported Event|Migraine + Cluster Headache|Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
10859205|NCT00356759|BG000|Baseline|Dose Assessment 4-weekly|INRs and dose assessments every 4 weeks true values, no sham INRs
10859206|NCT00356759|BG001|Baseline|Dose Assessment 12-weekly|INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
10859207|NCT00356759|BG002|Baseline|Total|Total of all reporting groups
10859208|NCT00356759|FG000|Participant Flow|Dose Assessment 4-weekly|INRs and dose assessments every 4 weeks true values, no sham INRs
10859209|NCT00356759|FG001|Participant Flow|Dose Assessment 12-weekly|INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
10859210|NCT00356759|OG000|Outcome|Dose Assessment 4-weekly|INRs and dose assessments every 4 weeks true values, no sham INRs
10859211|NCT00356759|OG001|Outcome|Dose Assessment 12-weekly|INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
10859212|NCT00356759|EG000|Reported Event|12-weekly INR|Patients had INR every 4 weeks but only every thisrd INR was true; the other two were sham INRs dampened to be within or close to therapeutic range. Thus, true dose assessment was in practice performed every 12 weeks
10859213|NCT00356759|EG001|Reported Event|4-weekly INR|Patients had INR every 4 weeks and all results were true. Thus, true dose assessments were performed every 4 weeks.
10859214|NCT00356811|BG000|Baseline|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10859215|NCT00356811|FG000|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10859216|NCT00356811|OG000|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10859217|NCT00356811|OG000|Outcome|Overall Study Arm|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10859218|NCT00356811|EG000|Reported Event|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10859219|NCT00356863|BG000|Baseline|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
10859220|NCT00356863|BG001|Baseline|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
10859221|NCT00356863|BG002|Baseline|Total|Total of all reporting groups
10859222|NCT00356863|FG000|Participant Flow|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
10859223|NCT00356863|FG001|Participant Flow|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
10859224|NCT00356863|OG000|Outcome|Education (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
10859225|NCT00356863|OG001|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about CR and were giving the usual care.
10859226|NCT00356863|OG000|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
10859227|NCT00356863|OG001|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
10859228|NCT00356863|OG000|Outcome|Educational (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
10859229|NCT00356863|OG001|Outcome|No Education (Control) About Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
10859230|NCT00356863|EG000|Reported Event|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
10859231|NCT00356863|EG001|Reported Event|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
10878965|NCT00454818|FG000|Participant Flow|MYDICAR® Very Low Dose|"Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.~This arm was included only in the Phase I open-label dose-escalation period."
10878966|NCT00454818|FG001|Participant Flow|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
10845659|NCT00268437|EG000|Reported Event|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
10859232|NCT00356889|BG000|Baseline|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
10859233|NCT00356889|FG000|Participant Flow|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
10859234|NCT00356889|OG000|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
10859235|NCT00356889|OG000|Outcome|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
10859236|NCT00356889|EG000|Reported Event|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
10859237|NCT00356915|BG000|Baseline|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
10859238|NCT00356915|BG001|Baseline|Itraconazole Capsules|Itraconazole 100 mg capsules
10859239|NCT00356915|BG002|Baseline|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
10859240|NCT00356915|BG003|Baseline|Total|Total of all reporting groups
10859241|NCT00356915|FG000|Participant Flow|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
10859242|NCT00356915|FG001|Participant Flow|Itraconazole Capsules|Itraconazole 100 mg capsules
10859243|NCT00356915|FG002|Participant Flow|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
10859244|NCT00356915|OG000|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
10859245|NCT00356915|OG001|Outcome|Placebo Tablets|
10859246|NCT00356915|OG000|Outcome|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
10859247|NCT00356915|OG001|Outcome|Itraconazole Capsules|Itraconazole 100 mg capsules
10859248|NCT00356915|OG002|Outcome|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
10859249|NCT00356915|OG001|Outcome|Itraconazole Capsules|Itraconazole 100mg capsules
10859250|NCT00356915|EG000|Reported Event|Itraconazole Tablets - Treatment Period|Itraconazole 200mg tablets Adverse events that occurred during the Treatment Period are reported here.
10859251|NCT00356915|EG001|Reported Event|Itraconazole Capsules|Itraconazole 100mg capsules Adverse events that occurred during the Treatment Period are reported here.
10859252|NCT00356915|EG002|Reported Event|Placebo Tablets|Adverse events that occurred during the Treatment Period are reported here.
10859253|NCT00356915|EG003|Reported Event|Itraconazole Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
10859254|NCT00356915|EG004|Reported Event|Itraconazole Capsules - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
10859255|NCT00356915|EG005|Reported Event|Placebo Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
10859256|NCT00356993|BG000|Baseline|NRT + Behavioural Support|"Nicotine Replacement Therapy plus Behavioural Intervention~Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge~behavioural intervention: Smoking cessation counselling, relapse prevention strategies"
10859257|NCT00356993|FG000|Participant Flow|NRT + Behavioural Support|"Nicotine Replacement Therapy plus Behavioural Intervention~Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge~behavioural intervention: Smoking cessation counselling, relapse prevention strategies"
10859258|NCT00356993|OG000|Outcome|NRT + Behavioural Support|"Nicotine Replacement Therapy plus Behavioural Intervention~Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge~behavioural intervention: Smoking cessation counselling, relapse prevention strategies"
10976927|NCT00942825|OG001|Outcome|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
11007031|NCT01089127|BG002|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007032|NCT01089127|BG003|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
10976928|NCT00942825|EG000|Reported Event|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
10859259|NCT00356993|EG000|Reported Event|NRT + Behavioural Support|"Nicotine Replacement Therapy plus Behavioural Intervention~Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge~behavioural intervention: Smoking cessation counselling, relapse prevention strategies"
10859260|NCT00357006|BG000|Baseline|Adjunctive 200 mcg Transdermal Estradiol|
10859261|NCT00357006|BG001|Baseline|Adjunctive 100 mcg Transdermal Estradiol|
10859262|NCT00357006|BG002|Baseline|Placebo|
10859263|NCT00357006|BG003|Baseline|Total|Total of all reporting groups
10859264|NCT00357006|FG000|Participant Flow|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 56 days.
10859265|NCT00357006|FG001|Participant Flow|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 56 days.
10859266|NCT00357006|FG002|Participant Flow|Placebo|Participants received daily transdermal placebo for 56 days.
10859267|NCT00357006|OG000|Outcome|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200 mcg transdermal estradiol for 56 days.
10859268|NCT00357006|OG001|Outcome|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100 mcg transdermal estradiol for 56 days.
10859269|NCT00357006|OG002|Outcome|Placebo|Participants received daily transdermal placebo for 56 days.
10859270|NCT00357006|EG000|Reported Event|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 8 weeks (56 days).
10859271|NCT00357006|EG001|Reported Event|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 8 weeks (56 days).
10859272|NCT00357006|EG002|Reported Event|Placebo|Participants received daily transdermal placebo for 8 weeks (56 days).
10859273|NCT00357032|BG000|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
10859274|NCT00357032|FG000|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
10859275|NCT00357032|OG000|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
10859276|NCT00357032|EG000|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
10859277|NCT00357097|BG000|Baseline|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
10859278|NCT00357097|BG001|Baseline|Placebo|Subjects who took no investigational product.
10859279|NCT00357097|BG002|Baseline|Total|Total of all reporting groups
10859280|NCT00357097|FG000|Participant Flow|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
10859281|NCT00357097|FG001|Participant Flow|Placebo|Subjects who took no investigational product.
10859282|NCT00357097|OG000|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
10859283|NCT00357097|OG001|Outcome|Placebo|Subjects who took no investigational product.
10859284|NCT00357097|EG000|Reported Event|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
10859285|NCT00357097|EG001|Reported Event|Placebo|Subjects who took no investigational product.
10859286|NCT00357110|BG000|Baseline|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
10859287|NCT00357110|BG001|Baseline|Anastrozole|anastrozole 1 mg
10859288|NCT00357110|BG002|Baseline|Total|Total of all reporting groups
10859289|NCT00357110|FG000|Participant Flow|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
10859290|NCT00357110|FG001|Participant Flow|Anastrozole|anastrozole 1 mg
10859291|NCT00357110|OG000|Outcome|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
10859292|NCT00357110|OG001|Outcome|Anastrozole|anastrozole 1 mg
10859293|NCT00357110|EG000|Reported Event|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
10859294|NCT00357110|EG001|Reported Event|Anastrozole|anastrozole 1 mg
10859295|NCT00357162|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10859296|NCT00357162|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10859297|NCT00357162|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10859298|NCT00357162|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10859299|NCT00357214|BG000|Baseline|Potassium Bicarbonate|"Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.~Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859300|NCT00357214|BG001|Baseline|Sodium Bicarbonate|"Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.~Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10976929|NCT00942825|EG001|Reported Event|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
10976930|NCT00942851|BG000|Baseline|Active|AH-8 containing topical intervention
10976931|NCT00942851|BG001|Baseline|Placebo|topical intervention WITHOUT AH-8
10976932|NCT00942851|BG002|Baseline|Total|Total of all reporting groups
10976933|NCT00942851|FG000|Participant Flow|Active|Topical intervention agent containing AH8 0.005% Twice daily application to the eyelids in standardized fashion.
10859301|NCT00357214|BG002|Baseline|Potassium Chloride|"Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.~Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859302|NCT00357214|BG003|Baseline|Microcrystalline Cellulose|"Participants will receive placebo is microcrystalline cellulose. This compound has no other name.~placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water"
10859303|NCT00357214|BG004|Baseline|Total|Total of all reporting groups
10859304|NCT00357214|FG000|Participant Flow|Potassium Bicarbonate|"Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.~Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859305|NCT00357214|FG001|Participant Flow|Sodium Bicarbonate|"Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.~Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859306|NCT00357214|FG002|Participant Flow|Potassium Chloride|"Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.~Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859307|NCT00357214|FG003|Participant Flow|Microcrystalline Cellulose|"Participants will receive placebo is microcrystalline cellulose. This compound has no other name.~placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water"
10859308|NCT00357214|OG000|Outcome|Potassium Bicarbonate|"Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.~Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859309|NCT00357214|OG001|Outcome|Sodium Bicarbonate|"Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.~Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859310|NCT00357214|OG002|Outcome|Potassium Chloride|"Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.~Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859311|NCT00357214|OG003|Outcome|Microcrystalline Cellulose|"Participants will receive placebo is microcrystalline cellulose. This compound has no other name.~placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water"
10859312|NCT00357214|EG000|Reported Event|Potassium Bicarbonate|"Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.~Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859313|NCT00357214|EG001|Reported Event|Sodium Bicarbonate|"Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.~Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859314|NCT00357214|EG002|Reported Event|Potassium Chloride|"Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.~Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water"
10859315|NCT00357214|EG003|Reported Event|Microcrystalline Cellulose|"Participants will receive placebo is microcrystalline cellulose. This compound has no other name.~placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water"
10859316|NCT00357331|BG000|Baseline|Placebo|
10859317|NCT00357331|BG001|Baseline|Potassium Citrate|
10859318|NCT00357331|BG002|Baseline|Total|Total of all reporting groups
10859319|NCT00357331|FG000|Participant Flow|Potassium Citrate|"Potassium Citrate 20 meq twice daily~potassium citrate: 20 meq by mouth in capsule form twice daily"
10859320|NCT00357331|FG001|Participant Flow|Placebo|"Placebo~Placebo 20 meq by mouth in capsule form twice daily"
10859321|NCT00357331|OG000|Outcome|Placebo|
10859322|NCT00357331|OG001|Outcome|Potassium Citrate|
10859323|NCT00357331|EG000|Reported Event|Potassium Citrate|"Potassium Citrate 20 meq twice daily~potassium citrate: 20 meq by mouth in capsule form twice daily"
10859324|NCT00357331|EG001|Reported Event|Placebo|"Placebo~potassium citrate: 20 meq by mouth in capsule form twice daily"
10859325|NCT00357370|BG000|Baseline|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
10859326|NCT00357370|BG001|Baseline|Placebo|Tablets, oral, once daily for 12 weeks
10859327|NCT00357370|BG002|Baseline|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
10859328|NCT00357370|BG003|Baseline|Total|Total of all reporting groups
10859329|NCT00357370|FG000|Participant Flow|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
10859330|NCT00357370|FG001|Participant Flow|Placebo|Tablets, oral, once daily for 12 weeks
10859331|NCT00357370|FG002|Participant Flow|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
10859332|NCT00357370|OG000|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
10859333|NCT00357370|OG001|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
10859334|NCT00357370|OG002|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
10859335|NCT00357370|EG000|Reported Event|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
10859336|NCT00357370|EG001|Reported Event|Placebo|Tablets, oral, once daily for 12 weeks
10859337|NCT00357370|EG002|Reported Event|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
10859338|NCT00357396|BG000|Baseline|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
10859339|NCT00357396|BG001|Baseline|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
10859340|NCT00357396|BG002|Baseline|Total|Total of all reporting groups
10859341|NCT00357396|FG000|Participant Flow|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
10859342|NCT00357396|FG001|Participant Flow|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
10859343|NCT00357396|OG000|Outcome|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
10859344|NCT00357396|EG000|Reported Event|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
10859345|NCT00357396|EG001|Reported Event|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
10859346|NCT00357500|BG000|Baseline|5-drug Metronmic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
10859347|NCT00357500|FG000|Participant Flow|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
10859348|NCT00357500|OG000|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
10859349|NCT00357500|EG000|Reported Event|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
10859350|NCT00357552|BG000|Baseline|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
10859351|NCT00357552|FG000|Participant Flow|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
10859352|NCT00357552|OG000|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
10859353|NCT00357552|OG000|Outcome|All Screened Subjects With Available Sequences|All screened individuals, for whom a sequence could be obtained, regardless of whether they enrolled or not.
10859354|NCT00357552|OG000|Outcome|Virologic Failures by Week 24.|Subjects who met virologic failure criteria by week 24, for whom a sequence could be obtained.
10859355|NCT00357552|OG000|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen. The study is ongoing. Results from entry to week 24 are posted. They will be updated upon completion of study duration of 104 weeks.
10859356|NCT00357552|OG000|Outcome|LPV/r Monotherapy|"Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) once a day will be added to their regimen.~Emtricitabine/Tenofovir disoproxil fumarate: Once daily~Lopinavir/Ritonavir: Twice daily"
10859357|NCT00357552|EG000|Reported Event|LPV/r|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
10859358|NCT00357656|BG000|Baseline|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
10859359|NCT00357656|BG001|Baseline|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
10859360|NCT00357656|BG002|Baseline|Total|Total of all reporting groups
10859361|NCT00357656|FG000|Participant Flow|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
10859362|NCT00357656|FG001|Participant Flow|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
10859363|NCT00357656|OG000|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
10859364|NCT00357656|OG001|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
10859365|NCT00357656|OG002|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
10859366|NCT00357656|OG003|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
10859367|NCT00357656|OG004|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
10859368|NCT00357656|OG005|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
10859369|NCT00357656|OG006|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
10859370|NCT00357656|OG007|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
10859371|NCT00357656|OG001|Outcome|Contiuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
10859372|NCT00357656|OG000|Outcome|Bolus Infusion|Bolus infusion of rAHF-PFM
10859373|NCT00357656|OG001|Outcome|Continuous Infusion|Continuous infusion of rAHF-PFM
10859374|NCT00357656|OG002|Outcome|Safety Analysis Set|All participants treated with at least one ADVATE (rAHF-PFM) dose.
10859375|NCT00357656|OG002|Outcome|Safety Analysis Set|All participants treated with at least one ADVATE (rAHF-PFM) dose
10859376|NCT00357656|EG000|Reported Event|Bolus Infusion|All participants who were randomized to receive bolus infusion (BI) of ADVATE (rAHF-PFM). At total of 31 participants were randomized and received at least one ADVATE (rAHF-PFM) dose.
10859377|NCT00357656|EG001|Reported Event|Continuous Infusion|All participants who were randomized to receive continuous infusion (CI) of ADVATE (rAHF-PFM). At total of 32 participants were randomized and received at least one ADVATE (rAHF-PFM) dose.
10859378|NCT00357656|EG002|Reported Event|Not Assigned Participants|All participants who were not assigned to either bolus infusion or continuous infusion but received at least one ADVATE (rAHF-PFM) dose during pharmacokinetic evaluation. A total of 9 participants received only the pharmacokinetic infusion and were not randomized.
10859379|NCT00357734|BG000|Baseline|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
10859380|NCT00357734|FG000|Participant Flow|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
10859381|NCT00357734|OG000|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
10859382|NCT00357734|EG000|Reported Event|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
10859383|NCT00357760|BG000|Baseline|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10859384|NCT00357760|BG001|Baseline|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
10859385|NCT00357760|BG002|Baseline|Total|Total of all reporting groups
10859386|NCT00357760|FG000|Participant Flow|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10859387|NCT00357760|FG001|Participant Flow|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
10859388|NCT00357760|OG000|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10859389|NCT00357760|OG001|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
10859390|NCT00357760|EG000|Reported Event|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10859391|NCT00357760|EG001|Reported Event|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
10859392|NCT00357877|BG000|Baseline|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
10859393|NCT00357877|BG001|Baseline|Active Dental Coating|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition
10859394|NCT00357877|BG002|Baseline|Total|Total of all reporting groups
10859395|NCT00357877|FG000|Participant Flow|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
10859396|NCT00357877|FG001|Participant Flow|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
10859397|NCT00357877|OG000|Outcome|Placebo|Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
10859398|NCT00357877|OG001|Outcome|Active|Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
10859399|NCT00357877|OG000|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
10859400|NCT00357877|OG001|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
10859401|NCT00357877|EG000|Reported Event|Placebo|Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
10859402|NCT00357877|EG001|Reported Event|Active|Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
10859403|NCT00357903|BG000|Baseline|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
10859404|NCT00357903|BG001|Baseline|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
10859405|NCT00357903|BG002|Baseline|Total|Total of all reporting groups
10859406|NCT00357903|FG000|Participant Flow|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
10859407|NCT00357903|FG001|Participant Flow|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
10859408|NCT00357903|OG000|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
10859409|NCT00357903|OG001|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
10859410|NCT00357903|OG000|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
10859411|NCT00357903|EG000|Reported Event|Total Adults|
10859412|NCT00357903|EG001|Reported Event|Pediatric Subjects|
10859413|NCT00357955|BG000|Baseline|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms~Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Role modeling : learning from peers with similar disease and problems~Interactive Education : interactive lectures with hands-on learning"
10859414|NCT00357955|BG001|Baseline|Usual Care|usual care
10859415|NCT00357955|BG002|Baseline|Total|Total of all reporting groups
10859416|NCT00357955|FG000|Participant Flow|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms~Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Role modeling : learning from peers with similar disease and problems~Interactive Education : interactive lectures with hands-on learning"
10859417|NCT00357955|FG001|Participant Flow|Usual Care|usual care
10859418|NCT00357955|OG000|Outcome|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Interactive Education: interactive lectures with hands-on learning~Role modeling: learning from peers with similar disease and problems~Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
10859419|NCT00357955|OG001|Outcome|Usual Care|The standard of care to patients with type 2 diabetes is provided by primary care providers at the VA Medical Center through individual clinic visits. The frequency of these visits for patients with diabetes averages approximately 4 months.usual care
10859420|NCT00357955|EG000|Reported Event|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Interactive Education: interactive lectures with hands-on learning~Role modeling: learning from peers with similar disease and problems~Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
10859421|NCT00357955|EG001|Reported Event|Usual Care|usual care
10859422|NCT00357968|BG000|Baseline|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days. Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
10859423|NCT00357968|BG001|Baseline|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for 14 days. Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
10859424|NCT00357968|BG002|Baseline|Total|Total of all reporting groups
10859425|NCT00357968|FG000|Participant Flow|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
10859426|NCT00357968|FG001|Participant Flow|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
10859427|NCT00357968|OG000|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
10859428|NCT00357968|OG001|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
10976934|NCT00942851|FG001|Participant Flow|Placebo|"Topical intervention agent WITHOUT AH-8. Identically appearing cream without the active ingredient.~Twice daily application to the eyelids in standardized fashion."
10976935|NCT00942851|OG000|Outcome|Active Ingredient- AH8|subjects receiving active intervention, ie topical cream containing 0.005% AH-8
10976936|NCT00942851|OG001|Outcome|Placebo|subjects receiving placebo intervention, ie identically-appearing topical cream without AH-8 content
10976937|NCT00942851|OG000|Outcome|Active Ingredient- AH8|
10976938|NCT00942851|OG001|Outcome|Placebo|
10976939|NCT00942851|OG000|Outcome|Active|AH-8 containing topical intervention
10976940|NCT00942851|OG001|Outcome|Placebo|topical intervention WITHOUT AH-8
10976941|NCT00942851|EG000|Reported Event|Active|AH-8 containing topical intervention
10976942|NCT00942851|EG001|Reported Event|Placebo|topical intervention WITHOUT AH-8
10976943|NCT00942890|BG000|Baseline|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
10976944|NCT00942890|BG001|Baseline|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
10859429|NCT00357968|OG000|Outcome|Prasugrel|Includes total number of evaluable samples from patients who received prasugrel in each maintenance dose period (40 in the first maintenance period and 45 in the second maintenance period).
10859430|NCT00357968|OG001|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (46 from the first maintenance dose period and 40 from the second maintenance dose period).
10859431|NCT00357968|OG001|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
10859432|NCT00357968|OG000|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
10859433|NCT00357968|OG001|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
10859434|NCT00357968|OG000|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
10859435|NCT00357968|OG001|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
10859436|NCT00357968|OG000|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for the next 14 days.
10859437|NCT00357968|OG001|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) for the next 14 days.
10859438|NCT00357968|OG001|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
10859439|NCT00357968|OG000|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose
10859440|NCT00357968|OG000|Outcome|Prasugrel|Includes the total number of evaluable samples from patients who received prasugrel in each maintenance dose period (50 from the first maintenance dose period and 50 from the second maintenance dose period)
10859441|NCT00357968|OG001|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (52 from the first maintenance dose period and 51 from the second maintenance dose period).
10859442|NCT00357968|EG000|Reported Event|Prasugrel Before Cross-over|One time oral loading dose (LD) of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
10859443|NCT00357968|EG001|Reported Event|Clopidogrel Before Cross-over|One time oral loading dose of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days.
10859444|NCT00357968|EG002|Reported Event|Prasugrel After Cross-over|Prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose)once daily for 14 days after cross-over from one time loading dose of clopidogrel 600 mg and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days
10859445|NCT00357968|EG003|Reported Event|Clopidogrel After Cross-over|Clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days after cross-over from one time loading dose of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10 mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
10859446|NCT00357994|BG000|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
10859447|NCT00357994|BG001|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
10859448|NCT00357994|BG002|Baseline|Total|Total of all reporting groups
10859449|NCT00357994|FG000|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
10976945|NCT00942890|BG002|Baseline|Total|Total of all reporting groups
10859450|NCT00357994|FG001|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
10859451|NCT00357994|OG000|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
10859452|NCT00357994|OG001|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
10859453|NCT00357994|EG000|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
10859454|NCT00357994|EG001|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
10859455|NCT00358007|BG000|Baseline|Cone Beam CT|Undergo a cone beam CT scan
10859456|NCT00358007|FG000|Participant Flow|Cone Beam CT|Undergo a cone beam CT scan
10859457|NCT00358007|OG000|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
10859458|NCT00358007|EG000|Reported Event|Cone Beam CT|Undergo a cone beam CT scan
10859459|NCT00358150|BG000|Baseline|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
10859460|NCT00358150|FG000|Participant Flow|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 milligram (mg) dose on Day 1 then eliglustat 50 mg twice daily (BID) from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 nanogram per milliliter [ng/mL] on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme), and if all other causes for lack of treatment effect had been evaluated and ruled out).
10859461|NCT00358150|OG000|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
10859462|NCT00358150|OG000|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 8. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
10859463|NCT00358150|EG000|Reported Event|Eliglustat 50 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg BID from Day 2 to Year 9.
10859464|NCT00358150|EG001|Reported Event|Eliglustat 100 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg capsule BID from Day 2 to Day 19 and then eliglustat 100 mg capsule BID from Day 20 to Year 9.
10859465|NCT00358150|EG002|Reported Event|Eliglustat|Participants who received eliglustat capsule as a single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID or eliglustat 100 mg BID from Day 20 to Year 9. Participants who discontinued prior to Day 20 dose had their dose group set to missing and are only included in the all participants group. The Eliglustat group contains all participants who were treated with Eliglustat, including 2 participants dosed with 50 mg QD and 1 participant dosed with 150 mg BID for majority of study. Participants who had dose adjustment will be presented in dose group they received for majority of study.
10859466|NCT00358215|BG000|Baseline|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
10859467|NCT00358215|BG001|Baseline|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
10859468|NCT00358215|BG002|Baseline|Total|Total of all reporting groups
10859469|NCT00358215|FG000|Participant Flow|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
10859470|NCT00358215|FG001|Participant Flow|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
10859471|NCT00358215|OG000|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
10859472|NCT00358215|OG001|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
10859473|NCT00358215|EG000|Reported Event|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
10859474|NCT00358215|EG001|Reported Event|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
10859475|NCT00358332|BG000|Baseline|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859476|NCT00358332|BG001|Baseline|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859477|NCT00358332|BG002|Baseline|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859478|NCT00358332|BG003|Baseline|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859479|NCT00358332|BG004|Baseline|Total|Total of all reporting groups
10859480|NCT00358332|FG000|Participant Flow|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859481|NCT00358332|FG001|Participant Flow|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859482|NCT00358332|FG002|Participant Flow|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859483|NCT00358332|FG003|Participant Flow|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859484|NCT00358332|OG000|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859485|NCT00358332|OG001|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859486|NCT00358332|OG002|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859487|NCT00358332|OG003|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859488|NCT00358332|EG000|Reported Event|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859489|NCT00358332|EG001|Reported Event|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859490|NCT00358332|EG002|Reported Event|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859491|NCT00358332|EG003|Reported Event|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
10859492|NCT00358436|BG000|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10859493|NCT00358436|BG001|Baseline|Placebo|Placebo by inhalation
10859494|NCT00358436|BG002|Baseline|Total|Total of all reporting groups
10859495|NCT00358436|FG000|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10859496|NCT00358436|FG001|Participant Flow|Placebo|Placebo by inhalation
10859497|NCT00358436|OG000|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10859498|NCT00358436|OG001|Outcome|Placebo|Placebo by inhalation
10859499|NCT00358436|OG000|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10859500|NCT00358436|OG001|Outcome|Placebo|Once daily administered via inhalation
10859501|NCT00358436|EG000|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10859502|NCT00358436|EG001|Reported Event|Placebo|Placebo by inhalation
10859503|NCT00358449|BG000|Baseline|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859504|NCT00358449|BG001|Baseline|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859505|NCT00358449|BG002|Baseline|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859506|NCT00358449|BG003|Baseline|Total|Total of all reporting groups
10859507|NCT00358449|FG000|Participant Flow|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859508|NCT00358449|FG001|Participant Flow|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859509|NCT00358449|FG002|Participant Flow|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859510|NCT00358449|OG000|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859511|NCT00358449|OG001|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859512|NCT00358449|OG002|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859513|NCT00358449|OG000|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859514|NCT00358449|OG000|Outcome|Mepolizumab 0.55/ 2.5/ 10 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859515|NCT00358449|EG000|Reported Event|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859516|NCT00358449|EG001|Reported Event|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859517|NCT00358449|EG002|Reported Event|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
10859518|NCT00358462|BG000|Baseline|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
10859519|NCT00358462|BG001|Baseline|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
10859520|NCT00358462|BG002|Baseline|Total|Total of all reporting groups
10859521|NCT00358462|FG000|Participant Flow|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
10859522|NCT00358462|FG001|Participant Flow|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
10859523|NCT00358462|OG000|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
10859524|NCT00358462|OG001|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
10859525|NCT00358462|OG000|Outcome|Active Azithromycin+Placebo Doxycycline|"Active azithromycin (1g) and placebo doxycycline~Azithromycin: two 500mg tablets or four 250mg tablets administered as a single dose"
10859526|NCT00358462|OG001|Outcome|Active Doxycycline+Placebo Azithromycin|"Active doxycycline and placebo azithromycin~Doxycycline: one 100mg capsule administered twice daily for seven days"
10859527|NCT00358462|OG000|Outcome|Cultivated Isolates|Azithromycin MIC's
10859528|NCT00358462|OG000|Outcome|Cultivated Isolates|Cultivated M. genitalium isolates that successfully underwent in vitro MICs for doxycycline
10859529|NCT00358462|OG000|Outcome|Azithromycin|Cultivated U. urealyticum biovar 2 isolates that successfully underwent in vitro MICs for azithromycin
10859530|NCT00358462|OG001|Outcome|Doxycycline|Cultivated U. urealyticum biovar 2 isolates that successfully underwent in vitro MICs for doxycycliine
10859531|NCT00358462|OG002|Outcome|Moxifloxacin|Cultivated U. urealyticum biovar 2 isolates that successfully underwent in vitro MICs for moxifloxacin
10859532|NCT00358462|OG000|Outcome|Azithromycin|Cultivated U. parvum isolates that successfully underwent in vitro MICs for azithromycin
10859533|NCT00358462|OG001|Outcome|Doxycycline|Cultivated U. parvum isolates that successfully underwent in vitro MICs for doxycycline
10859534|NCT00358462|OG002|Outcome|Moxifloxacin|Cultivated U. parvum isolates that successfully underwent in vitro MICs for moxifloxacin
10859535|NCT00358462|EG000|Reported Event|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
10859536|NCT00358462|EG001|Reported Event|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
10859537|NCT00358501|BG000|Baseline|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
10859538|NCT00358501|BG001|Baseline|Historical Control|The control group was selected from the historical medical charts of patients undergoing hematopoietic stem cell transplant (HSCT).
10859539|NCT00358501|BG002|Baseline|Total|Total of all reporting groups
10859540|NCT00358501|FG000|Participant Flow|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
10859541|NCT00358501|FG001|Participant Flow|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
10859542|NCT00358501|OG000|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
10859543|NCT00358501|OG001|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
10859544|NCT00358501|OG000|Outcome|Historical Control|
10859545|NCT00358501|EG000|Reported Event|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
10859546|NCT00358501|EG001|Reported Event|Historical Control|
11223098|NCT02351037|BG001|Baseline|Ibrutinib + LD-AraC Combination Cohort|"Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.~Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle."
10859547|NCT00358579|BG000|Baseline|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
10859548|NCT00358579|BG001|Baseline|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
10859549|NCT00358579|BG002|Baseline|Total|Total of all reporting groups
10859550|NCT00358579|FG000|Participant Flow|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
10859551|NCT00358579|FG001|Participant Flow|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
10859552|NCT00358579|OG000|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
10859553|NCT00358579|OG001|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
10859554|NCT00358579|EG000|Reported Event|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
10859555|NCT00358579|EG001|Reported Event|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
10859556|NCT00358644|BG000|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
10859557|NCT00358644|FG000|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
10859558|NCT00358644|OG000|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
10859559|NCT00358644|EG000|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
10859560|NCT00358657|BG000|Baseline|Treatment (Chemo, Total-body Irradiation, Transplant)|"See Detailed Description~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplantation~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic bone marrow transplantation~Sirolimus: Given PO~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo total-body irradiation"
10859561|NCT00358657|FG000|Participant Flow|Treatment (Chemo, Total-body Irradiation, Transplant)|"See Detailed Description~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplantation~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic bone marrow transplantation~Sirolimus: Given PO~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo total-body irradiation"
10859562|NCT00358657|OG000|Outcome|Treatment (Chemo, Total-body Irradiation, Transplant)|"See Detailed Description~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplantation~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic bone marrow transplantation~Sirolimus: Given PO~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo total-body irradiation"
10859563|NCT00358657|EG000|Reported Event|Treatment (Chemo, Total-body Irradiation, Transplant)|"See Detailed Description~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplantation~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic bone marrow transplantation~Sirolimus: Given PO~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo total-body irradiation"
10859564|NCT00358670|BG000|Baseline|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
10859565|NCT00358670|BG001|Baseline|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
10859566|NCT00358670|BG002|Baseline|Total|Total of all reporting groups
10859567|NCT00358670|FG000|Participant Flow|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
10859568|NCT00358670|FG001|Participant Flow|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 (NCT00251641) Baseline
10859569|NCT00358670|OG000|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
10859570|NCT00358670|OG001|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
10859571|NCT00358670|EG000|Reported Event|Maintenance Infliximab|
10859572|NCT00358670|EG001|Reported Event|Intermittent Infliximab|
10859573|NCT00358735|BG000|Baseline|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
10859574|NCT00358735|BG001|Baseline|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
10859575|NCT00358735|BG002|Baseline|Total|Total of all reporting groups
10859576|NCT00358735|FG000|Participant Flow|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
10859577|NCT00358735|FG001|Participant Flow|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
10859578|NCT00358735|OG000|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
10859579|NCT00358735|OG001|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
10859580|NCT00358735|EG000|Reported Event|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
10859581|NCT00358735|EG001|Reported Event|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
10859582|NCT00358826|BG000|Baseline|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
10859583|NCT00358826|BG001|Baseline|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
10859584|NCT00358826|BG002|Baseline|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
10859585|NCT00358826|BG003|Baseline|Placebo|Matching Placebo, oral dosing, 12 weeks
10859586|NCT00358826|BG004|Baseline|Total|Total of all reporting groups
10859587|NCT00358826|FG000|Participant Flow|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
10859588|NCT00358826|FG001|Participant Flow|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
10859589|NCT00358826|FG002|Participant Flow|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
10859590|NCT00358826|FG003|Participant Flow|Placebo|Matching Placebo, 12 weeks
10859591|NCT00358826|FG004|Participant Flow|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
10859592|NCT00358826|FG005|Participant Flow|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
10859593|NCT00358826|FG006|Participant Flow|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
10859594|NCT00358826|FG007|Participant Flow|Placebo MDCT Substudy|Matching Placebo, 24 weeks
10859595|NCT00358826|OG000|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
10859596|NCT00358826|OG001|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
10859597|NCT00358826|OG002|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
10859598|NCT00358826|OG003|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
10859599|NCT00358826|OG000|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
10859600|NCT00358826|OG001|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
10859601|NCT00358826|OG002|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
10859602|NCT00358826|OG003|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
10859603|NCT00358826|EG000|Reported Event|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
10859604|NCT00358826|EG001|Reported Event|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
10859605|NCT00358826|EG002|Reported Event|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
10859606|NCT00358826|EG003|Reported Event|Placebo|Matching Placebo, oral dosing, 12 weeks
10859607|NCT00358917|BG000|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
10859608|NCT00358917|BG001|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
10859609|NCT00358917|BG002|Baseline|Total|Total of all reporting groups
10859610|NCT00358917|FG000|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 milligram (mg) once daily (QD) tablet
10859611|NCT00358917|FG001|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 milligram (mg) twice daily (BID) tablet
10859612|NCT00358917|OG000|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
10859613|NCT00358917|OG001|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
10859614|NCT00358917|OG000|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet; 88% NNRTI-experienced, 47% PI-experienced (24% nelfinavir, 19% indinavir, 13% atazanavir).
10859615|NCT00358917|OG001|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet; 81% NNRTI-experienced, 45% PI-experienced (20% nelfinavir, 17% indinavir, 13% atazanavir).
10859616|NCT00358917|EG000|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
10859617|NCT00358917|EG001|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
10859618|NCT00358956|BG000|Baseline|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
10859619|NCT00358956|FG000|Participant Flow|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
10859620|NCT00358956|OG000|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
10859621|NCT00358956|EG000|Reported Event|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
10859622|NCT00359021|BG000|Baseline|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
10859623|NCT00359021|BG001|Baseline|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
10859624|NCT00359021|BG002|Baseline|Total|Total of all reporting groups
10859625|NCT00359021|FG000|Participant Flow|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
10859626|NCT00359021|FG001|Participant Flow|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
10859627|NCT00359021|OG000|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
10859628|NCT00359021|OG001|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
10859629|NCT00359021|OG002|Outcome|All Participants|DUET Placebo + DUET TMC125
10859630|NCT00359021|EG000|Reported Event|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
10859631|NCT00359021|EG001|Reported Event|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
10859632|NCT00359021|EG002|Reported Event|All Participants|Participants who received placebo or TMC125 in a previous DUET study (DUET Placebo + DUET TMC125).
10859633|NCT00359073|BG000|Baseline|Montelukast|subjects received study drug montelukast, 10 mg once per day
10859634|NCT00359073|BG001|Baseline|Placebo|subjects received placebo, once per day
10859635|NCT00359073|BG002|Baseline|Total|Total of all reporting groups
10859636|NCT00359073|FG000|Participant Flow|Montelukast|subjects received study drug montelukast, 10 mg once per day
10859637|NCT00359073|FG001|Participant Flow|Placebo|subjects received placebo, once per day
10859638|NCT00359073|OG000|Outcome|Montelukast|subjects received study drug montelukast, 10 mg once per day
10859639|NCT00359073|OG001|Outcome|Placebo|subjects received placebo, once per day
10859640|NCT00359073|OG000|Outcome|Montelukast|"montelukast (10 mg everyday)~montelukast: 10 mg everyday"
10859641|NCT00359073|OG001|Outcome|Placebo|"Placebo comparator~placebo: like placebo"
10859642|NCT00359073|EG000|Reported Event|Montelukast|subjects received study drug montelukast, 10 mg once per day
10859643|NCT00359073|EG001|Reported Event|Placebo|subjects received placebo, once per day
10859644|NCT00359203|BG000|Baseline|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
10859645|NCT00359203|BG001|Baseline|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
10859646|NCT00359203|BG002|Baseline|Total|Total of all reporting groups
10859647|NCT00359203|FG000|Participant Flow|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
10859648|NCT00359203|FG001|Participant Flow|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
10859649|NCT00359203|OG000|Outcome|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
10859650|NCT00359203|OG001|Outcome|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
10859651|NCT00359203|EG000|Reported Event|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
10859652|NCT00359203|EG001|Reported Event|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
10859653|NCT00359281|BG000|Baseline|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
10859654|NCT00359281|BG001|Baseline|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
10859655|NCT00359281|BG002|Baseline|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
10859656|NCT00359281|BG003|Baseline|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
10859657|NCT00359281|BG004|Baseline|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
10859658|NCT00359281|BG005|Baseline|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
10859659|NCT00359281|BG006|Baseline|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
10859660|NCT00359281|BG007|Baseline|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
10859661|NCT00359281|BG008|Baseline|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
10859662|NCT00359281|BG009|Baseline|Total|Total of all reporting groups
10859663|NCT00359281|FG000|Participant Flow|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
10859664|NCT00359281|FG001|Participant Flow|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
10859665|NCT00359281|FG002|Participant Flow|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
10859666|NCT00359281|FG003|Participant Flow|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
10859667|NCT00359281|FG004|Participant Flow|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
10859668|NCT00359281|FG005|Participant Flow|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
10859669|NCT00359281|FG006|Participant Flow|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
10859670|NCT00359281|FG007|Participant Flow|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
10859671|NCT00359281|FG008|Participant Flow|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
10859672|NCT00359281|OG000|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
10859673|NCT00359281|OG001|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
10859674|NCT00359281|OG002|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
10859675|NCT00359281|OG003|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
10859676|NCT00359281|OG004|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
10859677|NCT00359281|OG005|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
10859678|NCT00359281|OG006|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
10859679|NCT00359281|OG007|Outcome|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
10859680|NCT00359281|OG008|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
10859681|NCT00359281|OG000|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
10859682|NCT00359281|OG000|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
10859683|NCT00359281|OG000|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
10859684|NCT00359281|OG000|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
10859685|NCT00359281|OG000|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
10859686|NCT00359281|OG000|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
10859687|NCT00359281|OG000|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
10859688|NCT00359281|EG000|Reported Event|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
10859689|NCT00359281|EG001|Reported Event|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
10859690|NCT00359281|EG002|Reported Event|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
10859691|NCT00359281|EG003|Reported Event|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
10859692|NCT00359281|EG004|Reported Event|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
10859693|NCT00359281|EG005|Reported Event|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
10859694|NCT00359281|EG006|Reported Event|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
10859695|NCT00359281|EG007|Reported Event|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
10859696|NCT00359281|EG008|Reported Event|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
10859697|NCT00359294|BG000|Baseline|Dose-level I|PM00104: 0.053 mg/m2
10859698|NCT00359294|BG001|Baseline|Dose-level II|PM00104: 0.106 mg/m2
10859699|NCT00359294|BG002|Baseline|Dose-level III|PM00104: 0.212 mg/m2
10859700|NCT00359294|BG003|Baseline|Dose-level IV|PM00104: 0.318 mg/m2
10859701|NCT00359294|BG004|Baseline|Dose-level V|PM00104: 0.475 mg/m2
10859702|NCT00359294|BG005|Baseline|Total|Total of all reporting groups
10859703|NCT00359294|FG000|Participant Flow|Dose Level I|PM0104: 0.053 mg/m2
10859704|NCT00359294|FG001|Participant Flow|Dose-level II|PM00104: 0.106 mg/m2
10859705|NCT00359294|FG002|Participant Flow|Dose-level III|PM00104: 0.212 mg/m2
10859706|NCT00359294|FG003|Participant Flow|Dose Level IV|PM00104: 0.318 mg/m2
10859707|NCT00359294|FG004|Participant Flow|Dose Level V|PM0104: 0.475 mg/m2
10859708|NCT00359294|OG000|Outcome|Dose-level I|PM00104: 0.053 mg/m2
10859709|NCT00359294|OG001|Outcome|Dose-level II|PM00104: 0.106 mg/m2
10859710|NCT00359294|OG002|Outcome|Dose-level III|PM00104: 0.212 mg/m2
10859711|NCT00359294|OG003|Outcome|Dose-level IV|PM00104: 0.318 mg/m2
10859712|NCT00359294|OG004|Outcome|Dose-level V|PM00104: 0.475 mg/m2
10859713|NCT00359294|EG000|Reported Event|PM00104|All patients were to receive treatment for at least one 3-week cycle, which consisted of PM00104 administrations daily for 5 days and all study evaluations up to the next treatment cycle. Cycles were to be repeated every three weeks until disease progression, unacceptable toxicity, intercurrent serious illness, withdrawal of informed consent by the patient, Investigator's opinion, or treatment delay > 2 weeks. Patients were considered to be on study for the duration of their treatment and for the first 30 days following treatment discontinuation, defined as the day of the last PM00104 administration
10859714|NCT00359424|BG000|Baseline|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
10859715|NCT00359424|BG001|Baseline|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
10859716|NCT00359424|BG002|Baseline|Total|Total of all reporting groups
10859717|NCT00359424|FG000|Participant Flow|Endovascular Therapy|Endovascular therapy (group two) received a lower dose (0.09mg per kg bolus and 0.54mg/kilogram infusion over 40 minutes, maximum dose 53.6mg) or after Amendment #5, a standard dose of IV rt-PA (.9mg/kg with 10% as a bolus and the remainder over one hour) and then underwent an angiogram test (cerebral angiography) right after the medicine was given to check for blood clots. If a clot was not seen, then no more treatment was given. If a clot was seen, the neurointerventionalist chose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that would be most effective in reopening the blocked artery.
10859718|NCT00359424|FG001|Participant Flow|IV Rt-PA Alone|IV rt-PA alone (group one) received the standard dose (.9mg per kilogram with 10% as a bolus and the remainder as an infusion over 1 hour -maximum dose 90mg) of intravenous (IV) rt-PA alone.
10859719|NCT00359424|OG000|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
10859720|NCT00359424|OG001|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
10859721|NCT00359424|EG000|Reported Event|Endovascular|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) rightafter the medicine is given to check for blood clots. If a clot is not seenthen no more treatment will be given. If a clot is seen, theneurointerventionalist will then choose (based on the location andextent of the blood clot) a protocol approved endovascular treatmentgiven directly in the brain artery that will be most effective inreopening the blocked artery.
10859722|NCT00359424|EG001|Reported Event|IV Only|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
10859723|NCT00359619|BG000|Baseline|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859724|NCT00359619|BG001|Baseline|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859725|NCT00359619|BG002|Baseline|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859726|NCT00359619|BG003|Baseline|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859727|NCT00359619|BG004|Baseline|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859728|NCT00359619|BG005|Baseline|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859729|NCT00359619|BG006|Baseline|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859730|NCT00359619|BG007|Baseline|Total|Total of all reporting groups
10859731|NCT00359619|FG000|Participant Flow|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859732|NCT00359619|FG001|Participant Flow|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859733|NCT00359619|FG002|Participant Flow|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10845660|NCT00268762|BG000|Baseline|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
10859734|NCT00359619|FG003|Participant Flow|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859735|NCT00359619|FG004|Participant Flow|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859736|NCT00359619|FG005|Participant Flow|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859737|NCT00359619|FG006|Participant Flow|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859738|NCT00359619|OG000|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859739|NCT00359619|OG001|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859740|NCT00359619|OG002|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859741|NCT00359619|OG003|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859742|NCT00359619|OG004|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859743|NCT00359619|OG005|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859744|NCT00359619|OG006|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859745|NCT00359619|EG000|Reported Event|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859746|NCT00359619|EG001|Reported Event|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859747|NCT00359619|EG002|Reported Event|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859748|NCT00359619|EG003|Reported Event|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859749|NCT00359619|EG004|Reported Event|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859750|NCT00359619|EG005|Reported Event|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859751|NCT00359619|EG006|Reported Event|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10859752|NCT00359632|BG000|Baseline|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
10859753|NCT00359632|BG001|Baseline|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
10859754|NCT00359632|BG002|Baseline|Total|Total of all reporting groups
10859755|NCT00359632|FG000|Participant Flow|Linezolid|Participants received linezolid either as tablets, by mouth (PO) or as an intravenous (IV) infusion at a dose of 600 milligrams (mg), twice daily (BID). Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
10859756|NCT00359632|FG001|Participant Flow|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
10859757|NCT00359632|OG000|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
10859758|NCT00359632|OG001|Outcome|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
10859759|NCT00359632|EG000|Reported Event|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
10859760|NCT00359632|EG001|Reported Event|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
10859761|NCT00359736|BG000|Baseline|Sildenafil|Sildenafil 20 mg TID orally: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
10859762|NCT00359736|BG001|Baseline|Placebo|Identical Placebo: 20 mg TID orally
10859763|NCT00359736|BG002|Baseline|Total|Total of all reporting groups
10859764|NCT00359736|FG000|Participant Flow|Sildenafil|Sildenafil 20 mg TID orally : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
10859765|NCT00359736|FG001|Participant Flow|Placebo|Control group: Identical Placebo 20 mg TID orally
10859766|NCT00359736|OG000|Outcome|Sildenafil|"Sildenafil 20 mg tid~sildenafil: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients."
10859767|NCT00359736|OG001|Outcome|Placebo|Identical Placebo 20 mg tid
10859768|NCT00359736|OG000|Outcome|Sildenafil|Sildenafil 20 mg tid orally
10859769|NCT00359736|OG001|Outcome|Placebo|Identical Placebo 20mg tid orally
10859770|NCT00359736|EG000|Reported Event|Placebo|Control group
10859771|NCT00359736|EG001|Reported Event|Sildenafil|sildenafil : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
10859772|NCT00359762|BG000|Baseline|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
10859773|NCT00359762|BG001|Baseline|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
10859774|NCT00359762|BG002|Baseline|Total|Total of all reporting groups
10859775|NCT00359762|FG000|Participant Flow|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
10859776|NCT00359762|FG001|Participant Flow|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
10859777|NCT00359762|FG002|Participant Flow|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
10859778|NCT00359762|FG003|Participant Flow|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
10859779|NCT00359762|FG004|Participant Flow|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
10859780|NCT00359762|OG000|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
10859781|NCT00359762|OG001|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
10859782|NCT00359762|OG000|Outcome|Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
10859783|NCT00359762|OG001|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
10859784|NCT00359762|OG000|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
10859785|NCT00359762|OG000|Outcome|Exen + Metformin + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
10859786|NCT00359762|OG002|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
10859787|NCT00359762|EG000|Reported Event|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
10859788|NCT00359762|EG001|Reported Event|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
10859789|NCT00359762|EG002|Reported Event|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
10859790|NCT00359762|EG003|Reported Event|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
10859791|NCT00359762|EG004|Reported Event|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
10859792|NCT00359788|BG000|Baseline|Tiotropium|18 mcg once daily
10859793|NCT00359788|BG001|Baseline|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
10859794|NCT00359788|BG002|Baseline|Total|Total of all reporting groups
10859795|NCT00359788|FG000|Participant Flow|Tiotropium|18 mcg once daily
10859796|NCT00359788|FG001|Participant Flow|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
10859797|NCT00359788|OG000|Outcome|Tiotropium|18 mcg once daily
10859798|NCT00359788|OG001|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
10859799|NCT00359788|EG000|Reported Event|Tiotropium|18 mcg once daily
10859800|NCT00359788|EG001|Reported Event|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
10859801|NCT00359801|BG000|Baseline|Exubera®|Exubera® plus usual diabetes care
10859802|NCT00359801|BG001|Baseline|Non-Exubera®|Usual diabetes care
10859803|NCT00359801|BG002|Baseline|Total|Total of all reporting groups
10859804|NCT00359801|FG000|Participant Flow|Exubera®|Exubera® plus usual diabetes care
10859805|NCT00359801|FG001|Participant Flow|Non-Exubera®|Usual diabetes care
10859806|NCT00359801|OG000|Outcome|Exubera®|Exubera® plus usual diabetes care
10859807|NCT00359801|OG001|Outcome|Non-Exubera®|Usual diabetes care
10859808|NCT00359801|EG000|Reported Event|Exubera®|Exubera® plus usual diabetes care
10859809|NCT00359801|EG001|Reported Event|Non-Exubera®|Usual diabetes care
10859810|NCT00359944|BG000|Baseline|AC-3933|AC-3933, 5mg twice daily
10859811|NCT00359944|BG001|Baseline|AC-3933, 20 mg|AC-3933, 20 mg twice daily
10859812|NCT00359944|BG002|Baseline|Placebo|Sugar Pill twice daily
10859813|NCT00359944|BG003|Baseline|Total|Total of all reporting groups
10859814|NCT00359944|FG000|Participant Flow|AC-3933, 5 mg|AC-3933, 5mg twice daily
10859815|NCT00359944|FG001|Participant Flow|AC-3933, 20 mg|AC-3933, 20 mg twice daily
10859816|NCT00359944|FG002|Participant Flow|Placebo|Sugar Pill twice daily
10859817|NCT00359944|OG000|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
10859818|NCT00359944|OG001|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
10859819|NCT00359944|OG002|Outcome|Placebo|Sugar Pill twice daily
10859820|NCT00359944|EG000|Reported Event|AC-3933, 5 mg|AC-3933, 5mg twice daily
10859821|NCT00359944|EG001|Reported Event|AC-3933, 20 mg|AC-3933, 20 mg twice daily
10859822|NCT00359944|EG002|Reported Event|Placebo|Sugar Pill twice daily
10859823|NCT00359983|BG000|Baseline|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859824|NCT00359983|BG001|Baseline|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859825|NCT00359983|BG002|Baseline|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859826|NCT00359983|BG003|Baseline|Total|Total of all reporting groups
10859827|NCT00359983|FG000|Participant Flow|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859828|NCT00359983|FG001|Participant Flow|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859829|NCT00359983|FG002|Participant Flow|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859830|NCT00359983|OG000|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859831|NCT00359983|OG001|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859832|NCT00359983|OG002|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859833|NCT00359983|EG000|Reported Event|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859834|NCT00359983|EG001|Reported Event|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859835|NCT00359983|EG002|Reported Event|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
10859836|NCT00360009|BG000|Baseline|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
10859837|NCT00360009|BG001|Baseline|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
10859838|NCT00360009|BG002|Baseline|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
10859839|NCT00360009|BG003|Baseline|Total|Total of all reporting groups
10859840|NCT00360009|FG000|Participant Flow|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
10859841|NCT00360009|FG001|Participant Flow|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
10859842|NCT00360009|FG002|Participant Flow|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
10859843|NCT00360009|OG000|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
10859844|NCT00360009|OG001|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
10859845|NCT00360009|OG002|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
10859846|NCT00360009|EG000|Reported Event|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
10859847|NCT00360009|EG001|Reported Event|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
10859848|NCT00360009|EG002|Reported Event|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
10859849|NCT00360126|BG000|Baseline|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
10859850|NCT00360126|FG000|Participant Flow|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
10859851|NCT00360126|OG000|Outcome|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
10859852|NCT00360126|EG000|Reported Event|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
10859853|NCT00360230|BG000|Baseline|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859854|NCT00360230|BG001|Baseline|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859855|NCT00360230|BG002|Baseline|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859856|NCT00360230|BG003|Baseline|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859857|NCT00360230|BG004|Baseline|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859858|NCT00360230|BG005|Baseline|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859859|NCT00360230|BG006|Baseline|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859860|NCT00360230|BG007|Baseline|Total|Total of all reporting groups
10859861|NCT00360230|FG000|Participant Flow|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859862|NCT00360230|FG001|Participant Flow|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859863|NCT00360230|FG002|Participant Flow|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859864|NCT00360230|FG003|Participant Flow|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859865|NCT00360230|FG004|Participant Flow|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859866|NCT00360230|FG005|Participant Flow|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859867|NCT00360230|FG006|Participant Flow|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859868|NCT00360230|OG000|Outcome|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859869|NCT00360230|OG001|Outcome|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859870|NCT00360230|OG002|Outcome|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859871|NCT00360230|OG003|Outcome|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859872|NCT00360230|OG004|Outcome|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859873|NCT00360230|OG005|Outcome|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859874|NCT00360230|OG006|Outcome|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859875|NCT00360230|OG000|Outcome|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859876|NCT00360230|OG001|Outcome|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859877|NCT00360230|EG000|Reported Event|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859878|NCT00360230|EG001|Reported Event|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859879|NCT00360230|EG002|Reported Event|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859880|NCT00360230|EG003|Reported Event|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859881|NCT00360230|EG004|Reported Event|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859882|NCT00360230|EG005|Reported Event|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859883|NCT00360230|EG006|Reported Event|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
10859884|NCT00360243|BG000|Baseline|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
10859885|NCT00360243|BG001|Baseline|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
10859886|NCT00360243|BG002|Baseline|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
10859887|NCT00360243|BG003|Baseline|Placebo|"twice daily for 24 weeks~placebo: placebo"
10859888|NCT00360243|BG004|Baseline|Total|Total of all reporting groups
10859889|NCT00360243|FG000|Participant Flow|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
10859890|NCT00360243|FG001|Participant Flow|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
10859891|NCT00360243|FG002|Participant Flow|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
10859892|NCT00360243|FG003|Participant Flow|Placebo|"twice daily for 24 weeks~placebo: placebo"
10859893|NCT00360243|OG000|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
10859894|NCT00360243|OG001|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
10859895|NCT00360243|OG002|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
10859896|NCT00360243|OG003|Outcome|Placebo|"twice daily for 24 weeks~placebo: placebo"
10859897|NCT00360243|EG000|Reported Event|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
10859898|NCT00360243|EG001|Reported Event|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
10859899|NCT00360243|EG002|Reported Event|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
10859900|NCT00360243|EG003|Reported Event|Placebo|"twice daily for 24 weeks~placebo: placebo"
10859901|NCT00360269|BG000|Baseline|Atomoxetine|Flexible dose up to 100mg/day
10859902|NCT00360269|BG001|Baseline|Placebo|Flexible dose up to 100mg/day
10859903|NCT00360269|BG002|Baseline|Total|Total of all reporting groups
10859904|NCT00360269|FG000|Participant Flow|Atomoxetine|Flexible dose up to 100mg/day
10859905|NCT00360269|FG001|Participant Flow|Placebo|Flexible dose up to 100mg/day
10859906|NCT00360269|OG000|Outcome|Atomoxetine|Flexible dose up to 100mg/day
10859907|NCT00360269|OG001|Outcome|Placebo|Flexible dose up to 100mg/day
10859908|NCT00360269|EG000|Reported Event|Atomoxetine|Flexible dose up to 100mg/day
10859909|NCT00360269|EG001|Reported Event|Placebo|Flexible dose up to 100mg/day
10859910|NCT00360282|BG000|Baseline|All Study Participants|Includes participants (migraineurs) with and without vertigo
10859911|NCT00360282|FG000|Participant Flow|With Vertigo; Placebo-Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They were given placebo on visit one and Rizatriptan on visit 2.
10859912|NCT00360282|FG001|Participant Flow|Without Vertigo; Placebo - Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. This group received placebo on visit 1 and Rizatriptan on visit 2.
10859913|NCT00360282|FG002|Participant Flow|With Vertigo; Rizatriptan - Placebo|These participants suffered from migraine and had associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
10859914|NCT00360282|FG003|Participant Flow|Without Vertigo; Rizatriptan - Placebo|These participants suffered from migraine without associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
10859915|NCT00360282|OG000|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
10859916|NCT00360282|OG001|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
10859917|NCT00360282|EG000|Reported Event|Without Vertigo; Placebo|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Placebo on one of the visits.
10859918|NCT00360282|EG001|Reported Event|Without Vertigo; Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Rizatriptan on one of the visits.
10859919|NCT00360282|EG002|Reported Event|With Vertigo; Placebo|These participants suffered from migraines with associated dizziness/vertigo. They received Placebo on one of the visits.
10859920|NCT00360282|EG003|Reported Event|With Vertigo; Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They received Rizatriptan on one of the visits.
10859921|NCT00360308|BG000|Baseline|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
10859922|NCT00360308|BG001|Baseline|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
10859923|NCT00360308|BG002|Baseline|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
10859924|NCT00360308|BG003|Baseline|Total|Total of all reporting groups
10859925|NCT00360308|FG000|Participant Flow|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
10859926|NCT00360308|FG001|Participant Flow|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
10859927|NCT00360308|FG002|Participant Flow|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
10859928|NCT00360308|OG000|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
10859929|NCT00360308|OG001|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
10859930|NCT00360308|OG002|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
10859931|NCT00360308|OG000|Outcome|Placebo|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
10859932|NCT00360308|OG001|Outcome|Entacapone|The total number of subjects reflects 5 fewer subjects due to inavailability of the data
10859933|NCT00360308|OG002|Outcome|Perampanel|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
10859934|NCT00360308|OG000|Outcome|Placebo|The total number of subjects reflects 1 fewer subject due to inavailability of the data
10859935|NCT00360308|EG000|Reported Event|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
10859936|NCT00360308|EG001|Reported Event|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
11348111|NCT04202497|FG003|Participant Flow|TAK-418 30 mg|TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348112|NCT04202497|OG000|Outcome|TAK-418 1.5 mg|TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348113|NCT04202497|OG001|Outcome|TAK-418 10 mg|TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348114|NCT04202497|OG002|Outcome|TAK-418 30 mg|TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348115|NCT04202497|OG000|Outcome|TAK-418|TAK-418 1.5 mg, 10 mg, or 30 mg capsules, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
10845661|NCT00268762|FG000|Participant Flow|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target partial thromboplastin time (PTT) of 1.75 times the patient's baseline.
10845662|NCT00268762|OG000|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
10845663|NCT00268762|EG000|Reported Event|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
10845664|NCT00268892|BG000|Baseline|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10845665|NCT00268892|BG001|Baseline|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10845666|NCT00268892|BG002|Baseline|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10845667|NCT00268892|BG003|Baseline|Total|Total of all reporting groups
10845668|NCT00268892|FG000|Participant Flow|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
11348116|NCT04202497|OG000|Outcome|Baseline [18F]MNI-1054|[18F]MNI-1054 up to 10 mCi, PET radiotracer injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348117|NCT04202497|OG001|Outcome|TAK-418 1.5 mg|TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348118|NCT04202497|OG002|Outcome|TAK-418 10 mg|TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348119|NCT04202497|OG003|Outcome|TAK-418 30 mg|TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348120|NCT04202497|EG000|Reported Event|Baseline [18F]MNI-1054|[18F]MNI-1054 up to 10 mCi, PET radiotracer injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348121|NCT04202497|EG001|Reported Event|TAK-418 1.5 mg|TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348122|NCT04202497|EG002|Reported Event|TAK-418 10 mg|TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
10859937|NCT00360308|EG002|Reported Event|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
10859938|NCT00360334|BG000|Baseline|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
10859939|NCT00360334|BG001|Baseline|Insulin Glargine|dosing based on treat to target protocol
10859940|NCT00360334|BG002|Baseline|Total|Total of all reporting groups
10859941|NCT00360334|FG000|Participant Flow|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
10859942|NCT00360334|FG001|Participant Flow|Insulin Glargine|dosing based on treat to target protocol
10859943|NCT00360334|OG000|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
10859944|NCT00360334|OG001|Outcome|Insulin Glargine|dosing based on treat to target protocol
10859945|NCT00360334|EG000|Reported Event|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
10859946|NCT00360334|EG001|Reported Event|Insulin Glargine|dosing based on treat to target protocol
10859947|NCT00360360|BG000|Baseline|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
10859948|NCT00360360|FG000|Participant Flow|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
10859949|NCT00360360|OG000|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
10859950|NCT00360360|EG000|Reported Event|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
10859951|NCT00360399|BG000|Baseline|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
10859952|NCT00360399|BG001|Baseline|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
10859953|NCT00360399|BG002|Baseline|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
10859954|NCT00360399|BG003|Baseline|Total|Total of all reporting groups
10859955|NCT00360399|FG000|Participant Flow|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
10859956|NCT00360399|FG001|Participant Flow|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
10859957|NCT00360399|FG002|Participant Flow|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
10859958|NCT00360399|OG000|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
10859959|NCT00360399|OG001|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
10859960|NCT00360399|OG002|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
10859961|NCT00360399|EG000|Reported Event|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
10859962|NCT00360399|EG001|Reported Event|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
10859963|NCT00360399|EG002|Reported Event|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
10859964|NCT00360412|BG000|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
10859965|NCT00360412|BG001|Baseline|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
10859966|NCT00360412|BG002|Baseline|Total|Total of all reporting groups
10859967|NCT00360412|FG000|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
10859968|NCT00360412|FG001|Participant Flow|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
10859969|NCT00360412|OG000|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
10859970|NCT00360412|OG001|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
10859971|NCT00360412|EG000|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
10859972|NCT00360412|EG001|Reported Event|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
10859973|NCT00360490|BG000|Baseline|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
10859974|NCT00360490|BG001|Baseline|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
10859975|NCT00360490|BG002|Baseline|Total|Total of all reporting groups
10859976|NCT00360490|FG000|Participant Flow|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
10859977|NCT00360490|FG001|Participant Flow|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
10859978|NCT00360490|OG000|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
10859979|NCT00360490|OG001|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
10859980|NCT00360490|EG000|Reported Event|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
10859981|NCT00360490|EG001|Reported Event|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
10878967|NCT00454818|FG002|Participant Flow|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
10878968|NCT00454818|FG003|Participant Flow|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
10878969|NCT00454818|FG004|Participant Flow|Placebo|"Single dose of placebo administered by antegrade epicardial coronary artery infusion.~The placebo arm was included only in the Phase 2 randomized double-blind period."
10878970|NCT00454818|OG000|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
10878971|NCT00454818|OG001|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
10878972|NCT00454818|OG002|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
10878973|NCT00454818|OG003|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
10878974|NCT00454818|OG000|Outcome|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
10878975|NCT00454818|OG001|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
10878976|NCT00454818|OG002|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
10878977|NCT00454818|OG003|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
10878978|NCT00454818|OG004|Outcome|All MYDICAR®|All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.
10878979|NCT00454818|OG005|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
10878980|NCT00454818|EG000|Reported Event|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11DRP administered by antegrade epicardial coronary artery infusion.
10859982|NCT00360529|BG000|Baseline|Placebo|placebo at bedtime
10859983|NCT00360529|BG001|Baseline|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
10859984|NCT00360529|BG002|Baseline|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
10859985|NCT00360529|BG003|Baseline|Total|Total of all reporting groups
10859986|NCT00360529|FG000|Participant Flow|Placebo|placebo at bedtime
10859987|NCT00360529|FG001|Participant Flow|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
10859988|NCT00360529|FG002|Participant Flow|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
10859989|NCT00360529|OG000|Outcome|Placebo|placebo at bedtime
10859990|NCT00360529|OG001|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
10859991|NCT00360529|OG002|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
10859992|NCT00360529|EG000|Reported Event|Placebo|placebo at bedtime
10859993|NCT00360529|EG001|Reported Event|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
10859994|NCT00360529|EG002|Reported Event|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
10859995|NCT00360555|BG000|Baseline|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
10859996|NCT00360555|BG001|Baseline|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
10859997|NCT00360555|BG002|Baseline|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
10859998|NCT00360555|BG003|Baseline|Placebo|flibanserin: placebo
10859999|NCT00360555|BG004|Baseline|Total|Total of all reporting groups
10860000|NCT00360555|FG000|Participant Flow|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
10860001|NCT00360555|FG001|Participant Flow|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
10860002|NCT00360555|FG002|Participant Flow|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
10860003|NCT00360555|FG003|Participant Flow|Placebo|flibanserin: placebo
10860004|NCT00360555|OG000|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
10860005|NCT00360555|OG001|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
10860006|NCT00360555|OG002|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
10860007|NCT00360555|OG003|Outcome|Placebo|flibanserin: placebo
10860008|NCT00360555|EG000|Reported Event|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
10860009|NCT00360555|EG001|Reported Event|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
10860010|NCT00360555|EG002|Reported Event|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
10860011|NCT00360555|EG003|Reported Event|Placebo|flibanserin: placebo
10860012|NCT00360568|BG000|Baseline|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
10860013|NCT00360568|BG001|Baseline|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
10860014|NCT00360568|BG002|Baseline|Total|Total of all reporting groups
10860015|NCT00360568|FG000|Participant Flow|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received levodopa-carbidopa intestinal gel (LCIG), delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
10860016|NCT00360568|FG001|Participant Flow|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
10860017|NCT00360568|OG000|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
10860018|NCT00360568|OG001|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
10860019|NCT00360568|OG002|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
10860020|NCT00360568|EG000|Reported Event|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
10860021|NCT00360568|EG001|Reported Event|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
10860022|NCT00360568|EG002|Reported Event|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
10860023|NCT00360672|BG000|Baseline|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
10860024|NCT00360672|FG000|Participant Flow|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
10860025|NCT00360672|OG000|Outcome|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
10860026|NCT00360672|EG000|Reported Event|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
10860027|NCT00360685|BG000|Baseline|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
10860028|NCT00360685|BG001|Baseline|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
10860029|NCT00360685|BG002|Baseline|Total|Total of all reporting groups
10860030|NCT00360685|FG000|Participant Flow|Tacrolimus And Methotrexate|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day -3 (day 0 being the anticipated day of hematopoietic stem cell infusion). Tacrolimus dosing should be based on ideal body weight. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing at a 1:3 (IV:PO) ratio. The daily oral dose will be divided into twice daily dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).~MTX 15 mg/m2 IV day +1 then 10 mg/m2 IV on days +3, +6, and +11."
10860031|NCT00360685|FG001|Participant Flow|Tacrolimus And Mycophenolate Mofetil|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day -3. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).~MMF 30 mg/kg/day IV in 2 divided doses beginning day 0. Dosing should be based on the lesser of adjusted ideal body weight or actual body weight. The IV dose will be converted to the oral formulation when spatient is able to tolerate oral medications. Oral dosing may be capped at 1 gram twice daily. In the absence of GVHD a tapering schedule will begin on day +240 (+14) and be completed on day +360 (+14)."
10860032|NCT00360685|OG000|Outcome|Tacrolimus And Methotrexate|Tacrolimus And Methotrexate
10860033|NCT00360685|OG001|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
10860034|NCT00360685|OG000|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
10860035|NCT00360685|EG000|Reported Event|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
10860036|NCT00360685|EG001|Reported Event|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
10860037|NCT00360698|BG000|Baseline|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
10860038|NCT00360698|BG001|Baseline|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
10860039|NCT00360698|BG002|Baseline|Total|Total of all reporting groups
10860040|NCT00360698|FG000|Participant Flow|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
10976946|NCT00942890|FG000|Participant Flow|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 wk after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
10845669|NCT00268892|FG001|Participant Flow|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10860041|NCT00360698|FG001|Participant Flow|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
10860042|NCT00360698|OG000|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
10860043|NCT00360698|OG001|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
10860044|NCT00360698|EG000|Reported Event|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
10860045|NCT00360698|EG001|Reported Event|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
10860046|NCT00360724|BG000|Baseline|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
10860047|NCT00360724|BG001|Baseline|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
10860048|NCT00360724|BG002|Baseline|Total|Total of all reporting groups
10860049|NCT00360724|FG000|Participant Flow|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
10860050|NCT00360724|FG001|Participant Flow|Placebo Treatment|placebo treatment, treatment with matching capsules of placebo
10860051|NCT00360724|OG000|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
10860052|NCT00360724|OG001|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
10860053|NCT00360724|OG001|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
10860054|NCT00360724|OG000|Outcome|Duloxetine (Cymbalta)|"Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine~Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
10860055|NCT00360724|OG001|Outcome|Placebo Treatment|"placebo treatment: treatment with placebo capsules that match active medication capsules~Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
10860056|NCT00360724|EG000|Reported Event|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
10860057|NCT00360724|EG001|Reported Event|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
10860058|NCT00360828|BG000|Baseline|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
10860059|NCT00360828|FG000|Participant Flow|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
10860060|NCT00360828|OG000|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
10860061|NCT00360828|EG000|Reported Event|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
10860062|NCT00360971|BG000|Baseline|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
10860063|NCT00360971|BG001|Baseline|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
10860064|NCT00360971|BG002|Baseline|Total|Total of all reporting groups
10860065|NCT00360971|FG000|Participant Flow|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
10860066|NCT00360971|FG001|Participant Flow|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
10860067|NCT00360971|OG000|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
10860068|NCT00360971|OG001|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
10860069|NCT00360971|EG000|Reported Event|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
10860070|NCT00360971|EG001|Reported Event|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
10860071|NCT00361140|BG000|Baseline|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
10860072|NCT00361140|BG001|Baseline|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
10860073|NCT00361140|BG002|Baseline|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
10860074|NCT00361140|BG003|Baseline|Total|Total of all reporting groups
10860075|NCT00361140|FG000|Participant Flow|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
10860076|NCT00361140|FG001|Participant Flow|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
10860077|NCT00361140|FG002|Participant Flow|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
10860078|NCT00361140|OG000|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
10860079|NCT00361140|OG001|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
10860080|NCT00361140|OG002|Outcome|AUC 9000|Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
10860081|NCT00361140|EG000|Reported Event|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
10860082|NCT00361140|EG001|Reported Event|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
10860083|NCT00361140|EG002|Reported Event|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
10860084|NCT00361218|BG000|Baseline|Open-label SSRI|"citalopram or escitalopram~open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
10860085|NCT00361218|FG000|Participant Flow|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
10860086|NCT00361218|OG000|Outcome|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
10860087|NCT00361218|EG000|Reported Event|Open-label SSRI|"citalopram or escitalopram~open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
10860088|NCT00361231|BG000|Baseline|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
10860089|NCT00361231|FG000|Participant Flow|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
10860090|NCT00361231|OG000|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Oxaliplatin"
10860091|NCT00361231|EG000|Reported Event|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side eff"
10860092|NCT00361257|BG000|Baseline|Minocycline|100 mg orally every 12 hours
10860093|NCT00361257|BG001|Baseline|Matching Placebo|Placebo taken orally every 12 hours
10860094|NCT00361257|BG002|Baseline|Total|Total of all reporting groups
10860095|NCT00361257|FG000|Participant Flow|Minocycline|100 mg orally every 12 hours
10860096|NCT00361257|FG001|Participant Flow|Matching Placebo|Placebo taken orally every 12 hours
10860097|NCT00361257|OG000|Outcome|Minocycline|100 mg orally every 12 hours
10860098|NCT00361257|OG001|Outcome|Matching Placebo|Placebo taken orally every 12 hours
10860099|NCT00361257|OG000|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
10860100|NCT00361257|OG001|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
10860101|NCT00361257|EG000|Reported Event|Minocycline|100 mg orally every 12 hours
10860102|NCT00361257|EG001|Reported Event|Matching Placebo|Placebo taken orally every 12 hours
10860103|NCT00361270|BG000|Baseline|Arm 1|"Single-site study at MEDVA-Houston~Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis"
10860104|NCT00361270|BG001|Baseline|Arm 2|"Single-site study at MEDVA-Houston~Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis with home practice with hypnosis CDs"
10860105|NCT00361270|BG002|Baseline|Arm 3|"Single-site study at MEDVA-Houston~Home practice with hypnosis CDs: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs"
10860106|NCT00361270|BG003|Baseline|Arm 4|"Single-site study at MEDVA-Houston~EMG Biofeedback without hypnotic suggestion: 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion"
10860107|NCT00361270|BG004|Baseline|Total|Total of all reporting groups
10860108|NCT00361270|FG000|Participant Flow|Hypnosis-8|8 sessions of hypnosis with no practice cds
10860109|NCT00361270|FG001|Participant Flow|Hypnosis-Practice 8|8 sessions hypnosis with practice cds
10860110|NCT00361270|FG002|Participant Flow|Hypnosis Practice 2|2 sessions of hypnosis with practice cds
10860111|NCT00361270|FG003|Participant Flow|Biofeedback - 8|8 sessions biofeedback
10860112|NCT00361270|OG000|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
10860113|NCT00361270|OG001|Outcome|Hypnosis-Practice 8|8 1-hour sessions of hypnosis with audio recordings
10860114|NCT00361270|OG002|Outcome|Hypnosis Practice 2|2 1-hour sessions of hypnosis with audio recordings
10860115|NCT00361270|OG003|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback
10860116|NCT00361270|OG000|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis with hypnotherapist without recordings
10860117|NCT00361270|OG001|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapists with audio recordings
10860118|NCT00361270|OG002|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
10860119|NCT00361270|OG003|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
10860120|NCT00361270|OG001|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist and audio recordings
10860121|NCT00361270|OG002|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist and audio recordings
10860122|NCT00361270|OG003|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback no recordings
10860123|NCT00361270|EG000|Reported Event|Hypnosis-8|8 1-hour sessions with hypnotherapist
10860124|NCT00361270|EG001|Reported Event|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist with audio recordings
10860125|NCT00361270|EG002|Reported Event|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
10860126|NCT00361270|EG003|Reported Event|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
10860127|NCT00361283|BG000|Baseline|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
10860128|NCT00361283|FG000|Participant Flow|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
10860129|NCT00361283|OG000|Outcome|Atorvastatin 80 MG/Day|Atorvastatin 80 MG/day
10860130|NCT00361283|EG000|Reported Event|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
10860131|NCT00361296|BG000|Baseline|K562/GM-CSF Cell Vaccine|"Vaccinations of 1x10^8 cells are given to participants at weeks 0, 3, 6, 9, and 17.~K562/GM-CSF cell vaccine"
10860132|NCT00361296|FG000|Participant Flow|K562/GM-CSF Cell Vaccine|"Vaccinations of 1x10^8 cells are given to participants at weeks 0, 3, 6, 9, and 17.~K562/GM-CSF cell vaccine"
10860133|NCT00361296|OG000|Outcome|K562/GM-CSF Cell Vaccine|"Vaccinations of 1x10^8 cells are given to participants at weeks 0, 3, 6, 9, and 17.~K562/GM-CSF cell vaccine"
10860134|NCT00361296|EG000|Reported Event|K562/GM-CSF Cell Vaccine|"Vaccinations of 1x10^8 cells are given to participants at weeks 0, 3, 6, 9, and 17.~K562/GM-CSF cell vaccine"
10860135|NCT00361335|BG000|Baseline|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
10860136|NCT00361335|BG001|Baseline|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
10860137|NCT00361335|BG002|Baseline|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
10860138|NCT00361335|BG003|Baseline|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
10860139|NCT00361335|BG004|Baseline|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
10860140|NCT00361335|BG005|Baseline|Total|Total of all reporting groups
10860141|NCT00361335|FG000|Participant Flow|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
10860142|NCT00361335|FG001|Participant Flow|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
10860143|NCT00361335|FG002|Participant Flow|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
10860144|NCT00361335|FG003|Participant Flow|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
10860145|NCT00361335|FG004|Participant Flow|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
10860146|NCT00361335|FG005|Participant Flow|EE/DRA -> 2mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered early escape (EE) and dose regimen adjustment (DRA), respectively, depending on joint assessment results and received IV infusions of 2mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
10860147|NCT00361335|FG006|Participant Flow|EE/DRA -> 4mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered EE and DRA, respectively, depending on joint assessment results and received IV infusions of 4mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
10860148|NCT00361335|OG000|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
10860149|NCT00361335|OG001|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
10860150|NCT00361335|OG002|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
10860151|NCT00361335|OG003|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
10860152|NCT00361335|OG004|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
10860153|NCT00361335|OG005|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
10860154|NCT00361335|OG006|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
10860155|NCT00361335|EG000|Reported Event|IV Period: 2mg/kg Golimumab+ MTX|Participants who received 2mg/kg IV golimumab and methotrexate (MTX). Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 2mg/kg IV golimumab and before receiving 4mg/kg IV golimumab
10860156|NCT00361335|EG001|Reported Event|IV Period: 2mg/kg Golimumab Only|Participants who received 2mg/kg IV golimumab only. Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 2mg/kg IV golimumab.
10860157|NCT00361335|EG002|Reported Event|IV Period: 4mg/kg Golimumab + MTX|Participants who received at least one 4 mg/kg IV golimumab dose and MTX. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 4mg/kg IV golimumab.
10860158|NCT00361335|EG003|Reported Event|IV Period: 4mg/kg Golimumab Only|Participants who received at least one 4mg/kg IV golimumab dose. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 4mg/kg IV golimumab.
10860159|NCT00361335|EG004|Reported Event|IV Period: Placebo + MTX|Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.
10860160|NCT00361335|EG005|Reported Event|SC Period: 50mg Golimumab + MTX|Participants who received 50mg SC golimumab and MTX.
10860161|NCT00361335|EG006|Reported Event|SC Period: 50mg Golimumab Only|Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
10860162|NCT00361374|BG000|Baseline|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
10860163|NCT00361374|BG001|Baseline|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
10860164|NCT00361374|BG002|Baseline|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
10860165|NCT00361374|BG003|Baseline|Total|Total of all reporting groups
10860166|NCT00361374|FG000|Participant Flow|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
10860167|NCT00361374|FG001|Participant Flow|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
10860168|NCT00361374|FG002|Participant Flow|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
10860169|NCT00361374|OG000|Outcome|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
10860170|NCT00361374|OG001|Outcome|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
10860171|NCT00361374|OG002|Outcome|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
10860172|NCT00361374|EG000|Reported Event|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
10860173|NCT00361374|EG001|Reported Event|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
10860174|NCT00361374|EG002|Reported Event|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
10860175|NCT00361439|BG000|Baseline|Mometasone|Active intranasal steroid therapy daily for 2 weeks
10860176|NCT00361439|BG001|Baseline|Placebo|2 puffs of placebo spray once daily
10860177|NCT00361439|BG002|Baseline|Total|Total of all reporting groups
10860178|NCT00361439|FG000|Participant Flow|Mometasone|Active intranasal steroid therapy daily for 2 weeks
10860179|NCT00361439|FG001|Participant Flow|Placebo|2 puffs of placebo spray once daily
10860180|NCT00361439|OG000|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
10860181|NCT00361439|OG001|Outcome|Placebo|2 puffs of placebo spray once daily
10860182|NCT00361439|EG000|Reported Event|Mometasone|Active intranasal steroid therapy daily for 2 weeks
10860183|NCT00361439|EG001|Reported Event|Placebo|2 puffs of placebo spray once daily
10860184|NCT00361504|BG000|Baseline|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
10860185|NCT00361504|BG001|Baseline|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
10860186|NCT00361504|BG002|Baseline|Total|Total of all reporting groups
10860187|NCT00361504|FG000|Participant Flow|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year
10860188|NCT00361504|FG001|Participant Flow|Oxycodone|Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
10860189|NCT00361504|OG000|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
10860190|NCT00361504|OG001|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
10860191|NCT00361504|EG000|Reported Event|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
10860192|NCT00361504|EG001|Reported Event|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
10860193|NCT00361569|BG000|Baseline|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
10860194|NCT00361569|BG001|Baseline|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
10860195|NCT00361569|BG002|Baseline|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
10860196|NCT00361569|BG003|Baseline|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
10860197|NCT00361569|BG004|Baseline|Total|Total of all reporting groups
10860198|NCT00361569|FG000|Participant Flow|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
10860199|NCT00361569|FG001|Participant Flow|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
10860200|NCT00361569|FG002|Participant Flow|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
10860201|NCT00361569|FG003|Participant Flow|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
10860202|NCT00361569|OG000|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
10860203|NCT00361569|OG001|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
10860204|NCT00361569|OG002|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
10860205|NCT00361569|OG003|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
10860206|NCT00361569|EG000|Reported Event|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
10860207|NCT00361569|EG001|Reported Event|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
10860208|NCT00361569|EG002|Reported Event|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
10860209|NCT00361569|EG003|Reported Event|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
10860210|NCT00361595|BG000|Baseline|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
10860211|NCT00361595|FG000|Participant Flow|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
10860212|NCT00361595|OG000|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
10860213|NCT00361595|EG000|Reported Event|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
10860214|NCT00361634|BG000|Baseline|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
10860215|NCT00361634|FG000|Participant Flow|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
10860216|NCT00361634|OG000|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
10860217|NCT00361634|EG000|Reported Event|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
10860218|NCT00361712|BG000|Baseline|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
10860219|NCT00361712|BG001|Baseline|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
10860220|NCT00361712|BG002|Baseline|Total|Total of all reporting groups
10860221|NCT00361712|FG000|Participant Flow|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
10860222|NCT00361712|FG001|Participant Flow|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
10860223|NCT00361712|OG000|Outcome|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
10860224|NCT00361712|OG001|Outcome|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
10860225|NCT00361712|EG000|Reported Event|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
10860226|NCT00361712|EG001|Reported Event|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
10860227|NCT00361842|BG000|Baseline|Irinotecan - Naïve|
10860228|NCT00361842|BG001|Baseline|Irinotecan - Exposed|
10860229|NCT00361842|BG002|Baseline|Total|Total of all reporting groups
10860230|NCT00361842|FG000|Participant Flow|Irinotecan - Naïve|
10860231|NCT00361842|FG001|Participant Flow|Irinotecan - Exposed|
10860232|NCT00361842|OG000|Outcome|Irinotecan - Naïve|"No prior exposure to irinotecan~No more than 1 regimen for metastatic disease~No more than 2 regimens overall;~1 for neoadjuvant/adjuvant and 1 for metastatic/advanced disease"
10860233|NCT00361842|OG001|Outcome|Irinotecan - Exposed|"Prior exposure to irinotecan was required~Disease progression on or within 6 months after completion of prior irinotecan-containing regimen~CPX-1 treatment must start within 12 months after documentation of disease progression on irinotecan (other therapies are permitted after irinotecan and before study entry)"
10860234|NCT00361842|OG000|Outcome|Irinotecan - Naïve|
10860235|NCT00361842|OG001|Outcome|Irinotecan - Exposed|
10860236|NCT00361842|EG000|Reported Event|Irinotecan - Naïve|
10860237|NCT00361842|EG001|Reported Event|Irinotecan - Exposed|
10860238|NCT00361972|BG000|Baseline|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
10860239|NCT00361972|BG001|Baseline|Placebo|placebo comparator to lansoprazole 30 mg twice daily for 6 weeks
10860240|NCT00361972|BG002|Baseline|Total|Total of all reporting groups
10860241|NCT00361972|FG000|Participant Flow|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
10860242|NCT00361972|FG001|Participant Flow|Placebo|placebo comparator to lansoprazole, 30 mg, twice a day for 6 weeks
10860243|NCT00361972|OG000|Outcome|Lansoprazole|lansoprazole: 30 mg lansoprazole twice daily for 6 weeks
10860244|NCT00361972|OG001|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
10860245|NCT00361972|OG000|Outcome|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
10860246|NCT00361972|EG000|Reported Event|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
10860247|NCT00361972|EG001|Reported Event|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
10860248|NCT00362115|BG000|Baseline|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860249|NCT00362115|BG001|Baseline|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860250|NCT00362115|BG002|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860251|NCT00362115|BG003|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860252|NCT00362115|BG004|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860253|NCT00362115|BG005|Baseline|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860254|NCT00362115|BG006|Baseline|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
10860255|NCT00362115|BG007|Baseline|Total|Total of all reporting groups
10860256|NCT00362115|FG000|Participant Flow|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860257|NCT00362115|FG001|Participant Flow|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860258|NCT00362115|FG002|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860259|NCT00362115|FG003|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860260|NCT00362115|FG004|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860261|NCT00362115|FG005|Participant Flow|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860262|NCT00362115|FG006|Participant Flow|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
10860263|NCT00362115|OG000|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860264|NCT00362115|OG001|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860265|NCT00362115|OG002|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860266|NCT00362115|OG003|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860267|NCT00362115|OG004|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860268|NCT00362115|OG005|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860269|NCT00362115|OG006|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
10860270|NCT00362115|EG000|Reported Event|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860271|NCT00362115|EG001|Reported Event|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860272|NCT00362115|EG002|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860273|NCT00362115|EG003|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860274|NCT00362115|EG004|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860275|NCT00362115|EG005|Reported Event|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
10860276|NCT00362115|EG006|Reported Event|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
10860277|NCT00362128|BG000|Baseline|Observational|The study design was a cross-sectional observational cohort design.
10860278|NCT00362128|FG000|Participant Flow|Observational|The study design was a cross-sectional observational cohort design.
10860279|NCT00362128|OG000|Outcome|Observational|The study design was a cross-sectional observational cohort design.
10860280|NCT00362128|EG000|Reported Event|Observational|The study design was a cross-sectional observational cohort design.
10860281|NCT00362180|BG000|Baseline|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
10860282|NCT00362180|BG001|Baseline|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
10860283|NCT00362180|BG002|Baseline|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
10860284|NCT00362180|BG003|Baseline|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
10860285|NCT00362180|BG004|Baseline|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
10860286|NCT00362180|BG005|Baseline|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
10860287|NCT00362180|BG006|Baseline|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
10860288|NCT00362180|BG007|Baseline|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
10860289|NCT00362180|BG008|Baseline|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
10860290|NCT00362180|BG009|Baseline|Total|Total of all reporting groups
10860291|NCT00362180|FG000|Participant Flow|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
10860292|NCT00362180|FG001|Participant Flow|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
10860293|NCT00362180|FG002|Participant Flow|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
10860294|NCT00362180|FG003|Participant Flow|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
10860295|NCT00362180|FG004|Participant Flow|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
10860296|NCT00362180|FG005|Participant Flow|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
10860297|NCT00362180|FG006|Participant Flow|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
10860298|NCT00362180|FG007|Participant Flow|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
10860299|NCT00362180|FG008|Participant Flow|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
10860300|NCT00362180|OG000|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
10860301|NCT00362180|OG001|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
10860302|NCT00362180|OG002|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
10860303|NCT00362180|OG003|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
10860304|NCT00362180|OG004|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
10860305|NCT00362180|OG005|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
10860306|NCT00362180|OG006|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
10860307|NCT00362180|OG007|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
10860308|NCT00362180|OG005|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
10860309|NCT00362180|OG002|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
10860310|NCT00362180|OG006|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
10860311|NCT00362180|OG003|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
10860312|NCT00362180|OG004|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
10860313|NCT00362180|EG000|Reported Event|Placebo|Placebo
10860314|NCT00362180|EG001|Reported Event|Mipomersen|Mipomersen
10860315|NCT00362180|EG002|Reported Event|Not Treated|Not Treated
10860316|NCT00362232|BG000|Baseline|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
10860317|NCT00362232|BG001|Baseline|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
10860318|NCT00362232|BG002|Baseline|Total|Total of all reporting groups
10860319|NCT00362232|FG000|Participant Flow|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
10860320|NCT00362232|FG001|Participant Flow|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
10860321|NCT00362232|OG000|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
10860322|NCT00362232|OG001|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
10860323|NCT00362232|EG000|Reported Event|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
10860324|NCT00362232|EG001|Reported Event|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
10860325|NCT00362297|BG000|Baseline|Standard Dose|
10860326|NCT00362297|BG001|Baseline|High-dose|
10860327|NCT00362297|BG002|Baseline|Total|Total of all reporting groups
10860328|NCT00362297|FG000|Participant Flow|Standard Dose First, Then High Dose|
10860329|NCT00362297|FG001|Participant Flow|High Dose First, Then Standard Dose|
10860330|NCT00362297|OG000|Outcome|Standard Dose Valacyclovir|
10860331|NCT00362297|OG001|Outcome|High Dose Acyclovir|
10860332|NCT00362297|EG000|Reported Event|Standard Dose|
10860333|NCT00362297|EG001|Reported Event|High-dose|
10860334|NCT00362336|BG000|Baseline|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860335|NCT00362336|BG001|Baseline|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860336|NCT00362336|BG002|Baseline|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860337|NCT00362336|BG003|Baseline|Total|Total of all reporting groups
10860338|NCT00362336|FG000|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860339|NCT00362336|FG001|Participant Flow|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860340|NCT00362336|FG002|Participant Flow|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860341|NCT00362336|OG000|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860342|NCT00362336|OG001|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860343|NCT00362336|OG002|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860344|NCT00362336|OG002|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860345|NCT00362336|OG002|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860346|NCT00362336|OG000|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860347|NCT00362336|OG000|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860348|NCT00362336|OG002|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860349|NCT00362336|OG000|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10878981|NCT00454818|EG001|Reported Event|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11DRP administered by antegrade epicardial coronary artery infusion.
10860350|NCT00362336|OG002|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860351|NCT00362336|EG000|Reported Event|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860352|NCT00362336|EG001|Reported Event|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860353|NCT00362336|EG002|Reported Event|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
10860354|NCT00362375|BG000|Baseline|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
10860355|NCT00362375|BG001|Baseline|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
10860356|NCT00362375|BG002|Baseline|Total|Total of all reporting groups
10860357|NCT00362375|FG000|Participant Flow|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
10860358|NCT00362375|FG001|Participant Flow|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
10860359|NCT00362375|OG000|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
10860360|NCT00362375|OG001|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
10860361|NCT00362375|EG000|Reported Event|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
10860362|NCT00362375|EG001|Reported Event|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
10860363|NCT00362414|BG000|Baseline|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
10860364|NCT00362414|FG000|Participant Flow|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
10860365|NCT00362414|OG000|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.~Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
10860366|NCT00362414|OG000|Outcome|Two Growth Factors|double growth factors
10860367|NCT00362414|OG000|Outcome|2 Growth Factors|double growth factors
10860368|NCT00362414|OG000|Outcome|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
10860369|NCT00362414|EG000|Reported Event|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
10860370|NCT00362440|BG000|Baseline|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
10860371|NCT00362440|BG001|Baseline|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
10860372|NCT00362440|BG002|Baseline|Total|Total of all reporting groups
10860373|NCT00362440|FG000|Participant Flow|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
10860374|NCT00362440|FG001|Participant Flow|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
10860375|NCT00362440|OG000|Outcome|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
10860376|NCT00362440|OG001|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
10860377|NCT00362440|EG000|Reported Event|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
10860378|NCT00362440|EG001|Reported Event|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
10860379|NCT00362453|BG000|Baseline|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
10860380|NCT00362453|BG001|Baseline|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
10860381|NCT00362453|BG002|Baseline|Total|Total of all reporting groups
10860382|NCT00362453|FG000|Participant Flow|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
10860383|NCT00362453|FG001|Participant Flow|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
10860384|NCT00362453|OG000|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
10860385|NCT00362453|OG001|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
10860386|NCT00362453|EG000|Reported Event|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
10860387|NCT00362453|EG001|Reported Event|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
10860388|NCT00362466|BG000|Baseline|Dasatinib|100 mg QD
10860389|NCT00362466|BG001|Baseline|Imatinib|600 mg QD
10860390|NCT00362466|BG002|Baseline|Total|Total of all reporting groups
10860391|NCT00362466|FG000|Participant Flow|Dasatinib|100 mg once daily (QD)
10860392|NCT00362466|FG001|Participant Flow|Imatinib|600 mg QD
10860393|NCT00362466|OG000|Outcome|Dasatinib|100 mg QD
10860394|NCT00362466|OG001|Outcome|Imatinib|600 mg QD
10860395|NCT00362466|EG000|Reported Event|Dasatinib|100 mg once daily (QD)
10860396|NCT00362466|EG001|Reported Event|Imatinib|600 mg QD
10860397|NCT00362609|BG000|Baseline|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
10860398|NCT00362609|BG001|Baseline|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
10860399|NCT00362609|BG002|Baseline|Total|Total of all reporting groups
10860400|NCT00362609|FG000|Participant Flow|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
10860401|NCT00362609|FG001|Participant Flow|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
10860402|NCT00362609|OG000|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
10860403|NCT00362609|OG001|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
10860404|NCT00362609|EG000|Reported Event|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
10860405|NCT00362609|EG001|Reported Event|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
10860406|NCT00362648|BG000|Baseline|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860407|NCT00362648|BG001|Baseline|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860408|NCT00362648|BG002|Baseline|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860409|NCT00362648|BG003|Baseline|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860410|NCT00362648|BG004|Baseline|Total|Total of all reporting groups
10860411|NCT00362648|FG000|Participant Flow|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860412|NCT00362648|FG001|Participant Flow|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860413|NCT00362648|FG002|Participant Flow|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860414|NCT00362648|FG003|Participant Flow|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860415|NCT00362648|OG000|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860416|NCT00362648|OG001|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860417|NCT00362648|OG002|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860418|NCT00362648|OG003|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860419|NCT00362648|OG000|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860420|NCT00362648|OG001|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10860421|NCT00362648|EG000|Reported Event|RotaTeq™|"Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).~Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
10860422|NCT00362648|EG001|Reported Event|Placebo|"Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.~SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).~Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
10860423|NCT00362648|EG002|Reported Event|RotaTeq™, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
10860424|NCT00362648|EG003|Reported Event|Placebo, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
10860425|NCT00362648|EG004|Reported Event|RotaTeq™ - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
10860426|NCT00362648|EG005|Reported Event|Placebo - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
10860427|NCT00362817|BG000|Baseline|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
10860428|NCT00362817|FG000|Participant Flow|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
10860429|NCT00362817|OG000|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
10860430|NCT00362817|OG000|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~carboplatin: IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.~temozolomide: 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks."
10860431|NCT00362817|EG000|Reported Event|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
10860432|NCT00362882|BG000|Baseline|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
10860433|NCT00362882|BG001|Baseline|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
10860434|NCT00362882|BG002|Baseline|Total|Total of all reporting groups
10860435|NCT00362882|FG000|Participant Flow|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
10860436|NCT00362882|FG001|Participant Flow|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
10860437|NCT00362882|OG000|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
10860438|NCT00362882|OG001|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
10860439|NCT00362882|EG000|Reported Event|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
10860440|NCT00362882|EG001|Reported Event|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
10860441|NCT00363051|BG000|Baseline|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
10860442|NCT00363051|BG001|Baseline|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
10860443|NCT00363051|BG002|Baseline|Total|Total of all reporting groups
10860444|NCT00363051|FG000|Participant Flow|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
10860445|NCT00363051|FG001|Participant Flow|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
10860446|NCT00363051|OG000|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
10860447|NCT00363051|OG000|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
10860448|NCT00363051|OG000|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
10860449|NCT00363051|OG001|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
10860450|NCT00363051|EG000|Reported Event|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
10860451|NCT00363051|EG001|Reported Event|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
10860452|NCT00363077|BG000|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10860453|NCT00363077|BG001|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10860454|NCT00363077|BG002|Baseline|Total|Total of all reporting groups
10860455|NCT00363077|FG000|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10860456|NCT00363077|FG001|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10860457|NCT00363077|OG000|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10860458|NCT00363077|OG001|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10860459|NCT00363077|EG000|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10860460|NCT00363077|EG001|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10860461|NCT00363129|BG000|Baseline|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
10860462|NCT00363129|BG001|Baseline|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
10860463|NCT00363129|BG002|Baseline|Total|Total of all reporting groups
10860464|NCT00363129|FG000|Participant Flow|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
10860465|NCT00363129|FG001|Participant Flow|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
10860466|NCT00363129|OG000|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
10860467|NCT00363129|OG001|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
10860468|NCT00363129|EG000|Reported Event|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
10860469|NCT00363129|EG001|Reported Event|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
10860470|NCT00363142|BG000|Baseline|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
10860471|NCT00363142|BG001|Baseline|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
10860472|NCT00363142|BG002|Baseline|Total|Total of all reporting groups
10860473|NCT00363142|FG000|Participant Flow|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
10860474|NCT00363142|FG001|Participant Flow|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
10860475|NCT00363142|OG000|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
10860476|NCT00363142|OG001|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
10860477|NCT00363142|OG000|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400/100mg once a day (QD)
10860478|NCT00363142|OG001|Outcome|FPV/r200|FPV/RTV (either 700/100mg twice a day [BID] or 1400/200mg QD)
10860479|NCT00363142|OG002|Outcome|FPV/RTV 700/100 mg BID|Twice daily FPV regimen boosted with a reduced dose of RTV 100 mg
10860480|NCT00363142|EG000|Reported Event|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
10860481|NCT00363142|EG001|Reported Event|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
10860482|NCT00363168|BG000|Baseline|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
10860483|NCT00363168|BG001|Baseline|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
10860484|NCT00363168|BG002|Baseline|Total|Total of all reporting groups
10860485|NCT00363168|FG000|Participant Flow|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
10860486|NCT00363168|FG001|Participant Flow|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
10860487|NCT00363168|OG000|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
10860488|NCT00363168|OG001|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
10860489|NCT00363168|EG000|Reported Event|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
10860490|NCT00363168|EG001|Reported Event|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
10860491|NCT00363246|BG000|Baseline|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
10860492|NCT00363246|FG000|Participant Flow|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
10860493|NCT00363246|OG000|Outcome|Wheelchair-using Veterans|Older veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
10860494|NCT00363246|OG000|Outcome|Wheelchair-using Veterans|Older Veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
10860495|NCT00363246|EG000|Reported Event|Elderly Veterans Using Wheelchairs for Mobility|Older veterans who use a wheelchair for their primary means of mobility. This was an observational study. There was no intervention and thus no adverse events were collected as part of the study. Sometimes we learned of a death from a relative when we called monthly.
10860496|NCT00363298|BG000|Baseline|D-amphetamine|"Dextro-amphetamine: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
10860497|NCT00363298|BG001|Baseline|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
10860498|NCT00363298|BG002|Baseline|Total|Total of all reporting groups
10860499|NCT00363298|FG000|Participant Flow|D-amphetamine|"Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
10860500|NCT00363298|FG001|Participant Flow|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
10860501|NCT00363298|OG000|Outcome|D-amphetamine|"Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
10860502|NCT00363298|OG001|Outcome|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
10860503|NCT00363298|OG000|Outcome|D-amphetamine|"Dextro-amphetamine: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
10860504|NCT00363298|EG000|Reported Event|D-amphetamine|Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
10860505|NCT00363298|EG001|Reported Event|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
10860506|NCT00363311|BG000|Baseline|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
10860507|NCT00363311|BG001|Baseline|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
10860508|NCT00363311|BG002|Baseline|Total|Total of all reporting groups
10860509|NCT00363311|FG000|Participant Flow|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks
10860510|NCT00363311|FG001|Participant Flow|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
10860511|NCT00363311|OG000|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
10860512|NCT00363311|OG001|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
10860513|NCT00363311|EG000|Reported Event|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
10860514|NCT00363311|EG001|Reported Event|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
10860515|NCT00363415|BG000|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
10860516|NCT00363415|BG001|Baseline|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
10860517|NCT00363415|BG002|Baseline|Total|Total of all reporting groups
10860518|NCT00363415|FG000|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
10860519|NCT00363415|FG001|Participant Flow|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
10860520|NCT00363415|OG000|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
10860521|NCT00363415|OG001|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
10860522|NCT00363415|EG000|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug)
10860523|NCT00363415|EG001|Reported Event|Etoposide + Carboplatin|"Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.~(Participants who received at least one dose of study drug)"
10860524|NCT00363467|BG000|Baseline|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
10860525|NCT00363467|FG000|Participant Flow|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
10860526|NCT00363467|OG000|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
10860527|NCT00363467|EG000|Reported Event|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
10860528|NCT00363480|BG000|Baseline|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
10878982|NCT00454818|EG002|Reported Event|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
10976947|NCT00942890|FG001|Participant Flow|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
10976948|NCT00942890|OG000|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
10976949|NCT00942890|OG001|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
11348123|NCT04202497|EG003|Reported Event|TAK-418 30 mg|TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of [18F]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received [18F]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
11348124|NCT04214080|BG000|Baseline|Study Group (SG)|"In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.~Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure)."
11348125|NCT04214080|BG001|Baseline|Control Group (CG).|"(NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills."
11348126|NCT04214080|BG002|Baseline|Total|Total of all reporting groups
11348127|NCT04214080|FG000|Participant Flow|Control Group (CG).|"(NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills."
11348128|NCT04214080|FG001|Participant Flow|Study Group (SG)|"In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.~Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure)."
11348129|NCT04214080|OG000|Outcome|Study Group (SG)|"In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.~Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure)."
10878983|NCT00454818|EG003|Reported Event|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
10878984|NCT00454818|EG004|Reported Event|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
10976950|NCT00942890|OG000|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
10976951|NCT00942890|EG000|Reported Event|Standard Rehabilitation Protocol|"The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1-week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for ~6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with the prosthetic leg and began post-prosthetic training. The training focus is lower limb prosthetic proficient in ambulation.~NMES (EMPI 300PV) plus standard of care: In addition to the standard rehabilitation, the NMES group will receive NMES to the quadriceps muscle of the residual & intact limb. The name of the NMES device is EMPI 300PV. NMES training will consist of 15-20 minute stimulation sessions with a 5-minute patient treatment log, 5 times/week for 12 weeks. During each session, 15 NMES contractions/leg will be completed. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device. This will be performed at home."
10976952|NCT00942890|EG001|Reported Event|NMES w/ Rehab|"The treatment group receives NMES to the quadriceps muscle of the residual & intact limb plus rehabilitation. The therapy consists of 12-weeks of NMES using the EMPI 300PV muscle stimulator. Participants train at home for 5 days/week; each session consisted of 15-20 min of NMES to each leg eliciting 15 contractions/leg (10 sec on:50 sec off), plus a 5-min tx log. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental.~NMES plus standard of care: In addition to the standard rehabilitation, the NMES treatment group will receive NMES to the quadriceps muscle of the residual & intact limb. EMPI 300PV is the NMES device. NMES training will consist of performing 15-20 minute stimulation sessions with a 5-minute patient tx log, 5 times/week for 12 weeks. During each session, 15 NMES contractions/leg will be completed at home. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device."
10976953|NCT00942903|BG000|Baseline|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
10976954|NCT00942903|FG000|Participant Flow|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
10976955|NCT00942903|OG000|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
10976956|NCT00942903|EG000|Reported Event|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
10976957|NCT00942968|BG000|Baseline|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
10976958|NCT00942968|FG000|Participant Flow|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
10976959|NCT00942968|OG000|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
10976960|NCT00942968|EG000|Reported Event|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
10976961|NCT00942994|BG000|Baseline|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
10976962|NCT00942994|BG001|Baseline|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
10976963|NCT00942994|BG002|Baseline|Total|Total of all reporting groups
10976964|NCT00942994|FG000|Participant Flow|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
10976965|NCT00942994|FG001|Participant Flow|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
10976966|NCT00942994|OG000|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
10976967|NCT00942994|OG001|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
10845670|NCT00268892|FG002|Participant Flow|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10860529|NCT00363480|FG000|Participant Flow|SFC 50/250 mcg|Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
10860530|NCT00363480|OG000|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
10860531|NCT00363480|EG000|Reported Event|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
10860532|NCT00363545|BG000|Baseline|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
10860533|NCT00363545|BG001|Baseline|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
10860534|NCT00363545|BG002|Baseline|Total|Total of all reporting groups
10860535|NCT00363545|FG000|Participant Flow|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
10860536|NCT00363545|FG001|Participant Flow|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
10860537|NCT00363545|OG000|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
10860538|NCT00363545|OG001|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
10860539|NCT00363545|EG000|Reported Event|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
10860540|NCT00363545|EG001|Reported Event|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
10860541|NCT00363649|BG000|Baseline|Arm A|"Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.~Interferon alfa: Given by injection~Sargramostim: Given by injection"
10860542|NCT00363649|BG001|Baseline|Arm B|"Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).~GM-K562 cell vaccine: Given by injection"
10860543|NCT00363649|BG002|Baseline|Total|Total of all reporting groups
10860544|NCT00363649|FG000|Participant Flow|Arm A|"Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.~Interferon alfa: Given by injection~Sargramostim: Given by injection"
10860545|NCT00363649|FG001|Participant Flow|Arm B|"Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).~GM-K562 cell vaccine: Given by injection"
10860546|NCT00363649|OG000|Outcome|Arm A|"Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.~Interferon alfa: Given by injection~Sargramostim: Given by injection"
10860547|NCT00363649|OG001|Outcome|Arm B|"Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).~GM-K562 cell vaccine: Given by injection"
10860548|NCT00363649|EG000|Reported Event|Arm A|"Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.~Interferon alfa: Given by injection~Sargramostim: Given by injection"
10878985|NCT00454857|BG000|Baseline|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
10860549|NCT00363649|EG001|Reported Event|Arm B|"Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).~GM-K562 cell vaccine: Given by injection"
10860550|NCT00363675|BG000|Baseline|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
10860551|NCT00363675|FG000|Participant Flow|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
10860552|NCT00363675|OG000|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
10860553|NCT00363675|OG000|Outcome|Normal as Defined by Hand Therapist.|Children were administered hand assessments to measure function after hand burns by a trained therapist.
10860554|NCT00363675|EG000|Reported Event|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
10860555|NCT00363766|BG000|Baseline|LY573636 Target Cmax 420 µg/mL|A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860556|NCT00363766|BG001|Baseline|LY573636 Target Cmax 380 µg/mL|A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860557|NCT00363766|BG002|Baseline|Total|Total of all reporting groups
10860558|NCT00363766|FG000|Participant Flow|LY573636 Target Cmax 420 µg/mL|A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860559|NCT00363766|FG001|Participant Flow|LY573636 Target Cmax 380 µg/mL|A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860560|NCT00363766|OG000|Outcome|LY573636 Target Cmax 420 µg/mL|A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860561|NCT00363766|OG001|Outcome|LY573636 Target Cmax 380 µg/mL|A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860562|NCT00363766|OG001|Outcome|LY573636 Target Cmax 380 µg/mL|A loading of LY573636 dose to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860563|NCT00363766|EG000|Reported Event|LY573636 Target Cmax 420 µg/mL|A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860564|NCT00363766|EG001|Reported Event|LY573636 Target Cmax 380 µg/mL|A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
10860565|NCT00363779|BG000|Baseline|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
10860566|NCT00363779|FG000|Participant Flow|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
10860567|NCT00363779|OG000|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
10860568|NCT00363779|EG000|Reported Event|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
10860569|NCT00363805|BG000|Baseline|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
10860570|NCT00363805|BG001|Baseline|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
10860571|NCT00363805|BG002|Baseline|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
10860572|NCT00363805|BG003|Baseline|Total|Total of all reporting groups
10860573|NCT00363805|FG000|Participant Flow|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
10860574|NCT00363805|FG001|Participant Flow|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
10860575|NCT00363805|FG002|Participant Flow|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
10860576|NCT00363805|OG000|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
10860577|NCT00363805|OG001|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
10860578|NCT00363805|OG002|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
10860579|NCT00363805|EG000|Reported Event|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
10860580|NCT00363805|EG001|Reported Event|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
10860581|NCT00363805|EG002|Reported Event|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
10860582|NCT00363883|BG000|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
10878986|NCT00454857|FG000|Participant Flow|Patients With ITP|Patients diagnosed with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) were followed prospectively for a period of 12 months.
11348599|NCT04158466|FG001|Participant Flow|Biotrue ONEday Daily Disposable Contact Lenses|"Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.~Biotrue ONEday Daily Disposable Contact Lenses: Contact lens"
11348600|NCT04158466|OG000|Outcome|Kalifilcon A Daily Disposable Contact Lenses|"Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.~Kalifilcon A Daily Disposable Contact Lenses: Contact lens"
11348601|NCT04158466|OG001|Outcome|Biotrue ONEday Daily Disposable Contact Lenses|"Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.~Biotrue ONEday Daily Disposable Contact Lenses: Contact lens"
10845671|NCT00268892|OG000|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
11348602|NCT04158466|EG000|Reported Event|Kalifilcon A Daily Disposable Contact Lenses|"Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.~Kalifilcon A Daily Disposable Contact Lenses: Contact lens"
11348603|NCT04158466|EG001|Reported Event|Biotrue ONEday Daily Disposable Contact Lenses|"Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.~Biotrue ONEday Daily Disposable Contact Lenses: Contact lens"
11348604|NCT04152083|BG000|Baseline|Eptinezumab|Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
11348605|NCT04152083|BG001|Baseline|Placebo|Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
11348606|NCT04152083|BG002|Baseline|Total|Total of all reporting groups
11348607|NCT04152083|FG000|Participant Flow|Eptinezumab|Participants received a single dose of eptinezumab 100 mg administered via intravenous (IV) infusion on Day 0.
11348608|NCT04152083|FG001|Participant Flow|Placebo|Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
11348609|NCT04152083|OG000|Outcome|Eptinezumab|Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
11348610|NCT04152083|OG001|Outcome|Placebo|Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
11348611|NCT04152083|EG000|Reported Event|Eptinezumab|Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
11348612|NCT04152083|EG001|Reported Event|Placebo|Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
11348613|NCT04155567|BG000|Baseline|TAK-123 3.75 g/m^2 NaPA and NaBZ|TAK-123 3.75 g/m^2 NaPA and TAK-123 3.75 g/m^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m^2 NaPA and TAK-123 3.75 g/m^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
11348614|NCT04155567|FG000|Participant Flow|TAK-123 3.75 g/m^2 NaPA and NaBZ|TAK-123 3.75 g/m^2 NaPA and TAK-123 3.75 g/m^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m^2 NaPA and TAK-123 3.75 g/m^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
11348615|NCT04155567|OG000|Outcome|TAK-123 3.75 g/m^2 NaPA and NaBZ|TAK-123 3.75 g/m^2 NaPA and TAK-123 3.75 g/m^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m^2 NaPA and TAK-123 3.75 g/m^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
11348616|NCT04155567|EG000|Reported Event|TAK-123 3.75 g/m^2 NaPA and NaBZ|TAK-123 3.75 g/m^2 NaPA and TAK-123 3.75 g/m^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m^2 NaPA and TAK-123 3.75 g/m^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
11348617|NCT04155047|BG000|Baseline|Glycopyrrolate Inhalation Solution (GIS) First, Then Placebo Inhalation Solution (PIS)|Treatment sequence AB: Single dose of GIS 25 mcg (Treatment A) to matching PIS (Treatment B)
11348618|NCT04155047|BG001|Baseline|Placebo Inhalation Solution (PIS) First, Then Glycopyrrolate Inhalation Solution (GIS)|Treatment sequence BA: Matching PIS (Treatment B) to single dose of GIS 25 mcg (Treatment A)
11348619|NCT04155047|BG002|Baseline|Total|Total of all reporting groups
11348620|NCT04155047|FG000|Participant Flow|Glycopyrrolate Inhalation Solution (GIS) First, Then Placebo Inhalation Solution (PIS)|Treatment sequence AB: Single dose of GIS 25 mcg (Treatment A) to matching PIS (Treatment B)
11348621|NCT04155047|FG001|Participant Flow|Placebo Inhalation Solution (PIS) First, Then Glycopyrrolate Inhalation Solution (GIS)|Treatment sequence BA: Matching PIS (Treatment B) to single dose of GIS 25 mcg (Treatment A)
11348622|NCT04155047|OG000|Outcome|Placebo|Placebo Inhalation Solution (PIS) administered by Magair
11348623|NCT04155047|OG001|Outcome|GIS 25 mcg Single Dose|Glycopyrrolate Inhalation Solution (GIS) 25 mcg administered by Magnair
11348624|NCT04155047|EG000|Reported Event|Placebo|Placebo Inhalation Solution (PIS) administered by Magair
11348625|NCT04155047|EG001|Reported Event|GIS 25 mcg Single Dose|Glycopyrrolate Inhalation Solution (GIS) 25 mcg administered by Magnair
11348626|NCT04152642|BG000|Baseline|Overall Study|single-center, randomized 3-treatment, 3-period crossover study
11348627|NCT04152642|FG000|Participant Flow|Overall Study|Single-center, randomized 3-treatment, 3-periods cross-over study.
10878987|NCT00454857|OG000|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
10878988|NCT00454857|EG000|Reported Event|Overall Study|
10878989|NCT00454909|BG000|Baseline|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878990|NCT00454909|BG001|Baseline|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878991|NCT00454909|BG002|Baseline|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878992|NCT00454909|BG003|Baseline|Total|Total of all reporting groups
10878993|NCT00454909|FG000|Participant Flow|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878994|NCT00454909|FG001|Participant Flow|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878995|NCT00454909|FG002|Participant Flow|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878996|NCT00454909|OG000|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878997|NCT00454909|OG001|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878998|NCT00454909|OG002|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10878999|NCT00454909|OG001|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10879000|NCT00454909|EG000|Reported Event|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10879001|NCT00454909|EG001|Reported Event|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10879002|NCT00454909|EG002|Reported Event|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
10879003|NCT00454987|BG000|Baseline|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
10879004|NCT00454987|BG001|Baseline|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
10879005|NCT00454987|BG002|Baseline|Meningitec+Hiberix Group|"Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.~This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme."
10879006|NCT00454987|BG003|Baseline|Total|Total of all reporting groups
10879007|NCT00454987|FG000|Participant Flow|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
10879008|NCT00454987|FG001|Participant Flow|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
10879009|NCT00454987|FG002|Participant Flow|Meningitec+Hiberix Group|"Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.~This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme."
10879010|NCT00454987|OG000|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
10879011|NCT00454987|OG001|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
10879012|NCT00454987|OG000|Outcome|Meningitec+Hiberix Group|"Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.~This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme."
10860583|NCT00363883|FG000|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
10860584|NCT00363883|OG000|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
10860585|NCT00363883|EG000|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
10860586|NCT00363896|BG000|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10860587|NCT00363896|BG001|Baseline|Placebo|Placebo by inhalation
10860588|NCT00363896|BG002|Baseline|Total|Total of all reporting groups
10860589|NCT00363896|FG000|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10860590|NCT00363896|FG001|Participant Flow|Placebo|Placebo by inhalation
10860591|NCT00363896|OG000|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
10860592|NCT00363896|OG001|Outcome|Placebo|Placebo once-daily via inhalation
10860593|NCT00363896|OG000|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
10860594|NCT00363896|OG000|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10860595|NCT00363896|OG001|Outcome|Placebo|Placebo by inhalation
10860596|NCT00363896|EG000|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
10860597|NCT00363896|EG001|Reported Event|Placebo|Placebo by inhalation
10860598|NCT00364013|BG000|Baseline|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
10860599|NCT00364013|BG001|Baseline|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
10860600|NCT00364013|BG002|Baseline|Total|Total of all reporting groups
10860601|NCT00364013|FG000|Participant Flow|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
10860602|NCT00364013|FG001|Participant Flow|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
10860603|NCT00364013|OG000|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
10860604|NCT00364013|OG001|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
10860605|NCT00364013|OG002|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
10860606|NCT00364013|OG003|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
10860607|NCT00364013|OG000|Outcome|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
10860608|NCT00364013|OG001|Outcome|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
10860609|NCT00364013|EG000|Reported Event|Panitumumab Plus FOLFOX|Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
10860610|NCT00364013|EG001|Reported Event|FOLFOX Alone|Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
10860611|NCT00364130|BG000|Baseline|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
10860612|NCT00364130|BG001|Baseline|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
10860613|NCT00364130|BG002|Baseline|Total|Total of all reporting groups
10860614|NCT00364130|FG000|Participant Flow|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
10860615|NCT00364130|FG001|Participant Flow|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
10860616|NCT00364130|OG000|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
10860617|NCT00364130|OG001|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
10860618|NCT00364130|OG000|Outcome|Active Low Magnitude Mechanical Stimulus|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus: 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
10860619|NCT00364130|OG001|Outcome|Inactive Low Magnitude Mechanical Stimulus|"Inactive, or placebo low magnitude mechanical stimulus~Placebo (inactive) low magnitude mechanical stimulus: 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device"
11348628|NCT04152642|OG000|Outcome|Water/Negative Control|"subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4.~Water control: negative control"
10860620|NCT00364130|EG000|Reported Event|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
10860621|NCT00364130|EG001|Reported Event|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
10860622|NCT00364156|BG000|Baseline|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
10860623|NCT00364156|BG001|Baseline|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
10860624|NCT00364156|BG002|Baseline|Total|Total of all reporting groups
10860625|NCT00364156|FG000|Participant Flow|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
10860626|NCT00364156|FG001|Participant Flow|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
10860627|NCT00364156|OG000|Outcome|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
10860628|NCT00364156|OG001|Outcome|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
10860629|NCT00364156|EG000|Reported Event|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
10860630|NCT00364156|EG001|Reported Event|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
10860631|NCT00364182|BG000|Baseline|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
10860632|NCT00364182|BG001|Baseline|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
10860633|NCT00364182|BG002|Baseline|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
10860634|NCT00364182|BG003|Baseline|Total|Total of all reporting groups
10860635|NCT00364182|FG000|Participant Flow|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
10860636|NCT00364182|FG001|Participant Flow|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
10860637|NCT00364182|FG002|Participant Flow|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
10860638|NCT00364182|OG000|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
10860639|NCT00364182|OG001|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
10860640|NCT00364182|OG002|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
10860641|NCT00364182|OG003|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
10860642|NCT00364182|EG000|Reported Event|BeneFIX OD1|BeneFIX in an on-demand IV bolus infusion for 16 weeks (first intervention)
10860643|NCT00364182|EG001|Reported Event|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
10860644|NCT00364182|EG002|Reported Event|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
10860645|NCT00364182|EG003|Reported Event|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
10860646|NCT00364286|BG000|Baseline|Dasatinib|Dasatinib 50mg Orally twice daily.
10860647|NCT00364286|FG000|Participant Flow|Dasatinib|Dasatinib 50mg Orally twice daily.
10860648|NCT00364286|OG000|Outcome|Dasatinib|Dasatinib 50mg Orally twice daily.
10860649|NCT00364286|EG000|Reported Event|Dasatinib|Dasatinib 50mg Orally twice daily.
10860650|NCT00364351|BG000|Baseline|Vandetanib|Vandetanib 300 mg
10860651|NCT00364351|BG001|Baseline|Erlotinib|Erlotinib
10860652|NCT00364351|BG002|Baseline|Total|Total of all reporting groups
10860653|NCT00364351|FG000|Participant Flow|Vandetanib|Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib
10860654|NCT00364351|FG001|Participant Flow|Erlotinib|Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib
10860655|NCT00364351|OG000|Outcome|Vandetanib|Vandetanib 300 mg
10860656|NCT00364351|OG001|Outcome|Erlotinib|Erlotinib
10860657|NCT00364351|EG000|Reported Event|Vandetanib|Vandetanib 300 mg.
10860658|NCT00364351|EG001|Reported Event|Erlotinib|Erlotinib.
10860659|NCT00364377|BG000|Baseline|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
10860660|NCT00364377|BG001|Baseline|Placebo|People with impaired fasting glucose treated with placebo once daily.
10860661|NCT00364377|BG002|Baseline|Total|Total of all reporting groups
10860662|NCT00364377|FG000|Participant Flow|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
11348629|NCT04152642|OG001|Outcome|Marketed Mouth Rinse|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.~Marketed Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
10860663|NCT00364377|FG001|Participant Flow|Placebo|People with impaired fasting glucose treated with placebo once daily.
10860664|NCT00364377|OG000|Outcome|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
10860665|NCT00364377|OG001|Outcome|Placebo|People with impaired fasting glucose treated with placebo once daily.
10860666|NCT00364377|EG000|Reported Event|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
10860667|NCT00364377|EG001|Reported Event|Placebo|People with impaired fasting glucose treated with placebo once daily.
10860668|NCT00364533|BG000|Baseline|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860669|NCT00364533|BG001|Baseline|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860670|NCT00364533|BG002|Baseline|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860671|NCT00364533|BG003|Baseline|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
10860672|NCT00364533|BG004|Baseline|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
10860673|NCT00364533|BG005|Baseline|Total|Total of all reporting groups
10860674|NCT00364533|FG000|Participant Flow|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860675|NCT00364533|FG001|Participant Flow|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860676|NCT00364533|FG002|Participant Flow|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860677|NCT00364533|FG003|Participant Flow|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
10860678|NCT00364533|FG004|Participant Flow|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
10860679|NCT00364533|OG000|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860680|NCT00364533|OG001|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860681|NCT00364533|OG002|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860682|NCT00364533|OG003|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
10860683|NCT00364533|OG004|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
10860684|NCT00364533|EG000|Reported Event|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860685|NCT00364533|EG001|Reported Event|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860686|NCT00364533|EG002|Reported Event|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
10860687|NCT00364533|EG003|Reported Event|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
10860688|NCT00364533|EG004|Reported Event|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
10860689|NCT00364611|BG000|Baseline|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
10860690|NCT00364611|BG001|Baseline|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
10860691|NCT00364611|BG002|Baseline|Total|Total of all reporting groups
10860692|NCT00364611|FG000|Participant Flow|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
10860693|NCT00364611|FG001|Participant Flow|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
10860694|NCT00364611|OG000|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
10860695|NCT00364611|OG001|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
10860696|NCT00364611|EG000|Reported Event|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
10860697|NCT00364611|EG001|Reported Event|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
10860698|NCT00364793|BG000|Baseline|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860699|NCT00364793|BG001|Baseline|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860700|NCT00364793|BG002|Baseline|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860701|NCT00364793|BG003|Baseline|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860702|NCT00364793|BG004|Baseline|Total|Total of all reporting groups
10860703|NCT00364793|FG000|Participant Flow|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860704|NCT00364793|FG001|Participant Flow|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860705|NCT00364793|FG002|Participant Flow|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860706|NCT00364793|FG003|Participant Flow|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860707|NCT00364793|OG000|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860708|NCT00364793|OG001|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860709|NCT00364793|OG002|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860710|NCT00364793|OG003|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860711|NCT00364793|OG004|Outcome|Total Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
10860712|NCT00364793|OG004|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860713|NCT00364793|OG000|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860714|NCT00364793|OG001|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860715|NCT00364793|OG002|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860716|NCT00364793|OG003|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860717|NCT00364793|EG000|Reported Event|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
10860718|NCT00364819|BG000|Baseline|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
10860719|NCT00364819|FG000|Participant Flow|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
10860720|NCT00364819|OG000|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
10860721|NCT00364819|EG000|Reported Event|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
10860722|NCT00364832|BG000|Baseline|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860723|NCT00364832|BG001|Baseline|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860724|NCT00364832|BG002|Baseline|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860725|NCT00364832|BG003|Baseline|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860726|NCT00364832|BG004|Baseline|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860727|NCT00364832|BG005|Baseline|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860728|NCT00364832|BG006|Baseline|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860729|NCT00364832|BG007|Baseline|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860730|NCT00364832|BG008|Baseline|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860731|NCT00364832|BG009|Baseline|Total|Total of all reporting groups
10860732|NCT00364832|FG000|Participant Flow|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneous (SC) using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860733|NCT00364832|FG001|Participant Flow|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860734|NCT00364832|FG002|Participant Flow|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860735|NCT00364832|FG003|Participant Flow|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860736|NCT00364832|FG004|Participant Flow|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860737|NCT00364832|FG005|Participant Flow|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860738|NCT00364832|FG006|Participant Flow|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860739|NCT00364832|FG007|Participant Flow|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860740|NCT00364832|FG008|Participant Flow|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860741|NCT00364832|FG009|Participant Flow|RO0503821 (1x/ Week)|Eligible participants were administered SC RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kilogram of the previous weekly ESA dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860742|NCT00364832|FG010|Participant Flow|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered SC RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860743|NCT00364832|FG011|Participant Flow|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered SC RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860744|NCT00364832|OG000|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860745|NCT00364832|OG001|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860746|NCT00364832|OG002|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860747|NCT00364832|OG003|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860748|NCT00364832|OG004|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860749|NCT00364832|OG005|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860750|NCT00364832|OG006|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860751|NCT00364832|OG007|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860752|NCT00364832|OG008|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860753|NCT00364832|OG000|Outcome|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860754|NCT00364832|OG001|Outcome|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860755|NCT00364832|OG002|Outcome|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860756|NCT00364832|EG000|Reported Event|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860757|NCT00364832|EG001|Reported Event|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860758|NCT00364832|EG002|Reported Event|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10860759|NCT00364845|BG000|Baseline|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
10860760|NCT00364845|BG001|Baseline|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
10860761|NCT00364845|BG002|Baseline|Total|Total of all reporting groups
10860762|NCT00364845|FG000|Participant Flow|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
10860763|NCT00364845|FG001|Participant Flow|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
10860764|NCT00364845|OG000|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
10860765|NCT00364845|OG001|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
10860766|NCT00364845|EG000|Reported Event|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
10860767|NCT00364845|EG001|Reported Event|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
10860768|NCT00364858|BG000|Baseline|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
10860769|NCT00364858|BG001|Baseline|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
10860770|NCT00364858|BG002|Baseline|Total|Total of all reporting groups
10860771|NCT00364858|FG000|Participant Flow|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
10860772|NCT00364858|FG001|Participant Flow|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
10860773|NCT00364858|OG000|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
10860774|NCT00364858|OG001|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
10860775|NCT00364858|EG000|Reported Event|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
10860776|NCT00364858|EG001|Reported Event|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
10860777|NCT00364858|EG002|Reported Event|Total|
10860778|NCT00364923|BG000|Baseline|Full Population|All patients who received at least one dose of pralatrexate
10860779|NCT00364923|FG000|Participant Flow|Full Population|All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.
10860780|NCT00364923|OG000|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
10860781|NCT00364923|EG000|Reported Event|Full Population|All patients who received at least one dose of pralatrexate
10860782|NCT00364949|BG000|Baseline|Control|Control
10860783|NCT00364949|BG001|Baseline|PCOS|Polycystic Ovary Syndrome
10860784|NCT00364949|BG002|Baseline|Total|Total of all reporting groups
10860785|NCT00364949|FG000|Participant Flow|Control|Control
10860786|NCT00364949|FG001|Participant Flow|PCOS|Polycystic Ovary Syndrome
10860787|NCT00364949|OG000|Outcome|Control|Control
10860788|NCT00364949|OG001|Outcome|PCOS|Polycystic Ovary Syndrome
10860789|NCT00364949|EG000|Reported Event|Control|Control
10860790|NCT00364949|EG001|Reported Event|PCOS|Polycystic Ovary Syndrome
10860791|NCT00365053|BG000|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
10860792|NCT00365053|FG000|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
10860793|NCT00365053|OG000|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
10860794|NCT00365053|EG000|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
10860795|NCT00365105|BG000|Baseline|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
10860796|NCT00365105|BG001|Baseline|Zoledronic Acid + Radiopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
10860797|NCT00365105|BG002|Baseline|Total|Total of all reporting groups
10860798|NCT00365105|FG000|Participant Flow|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
10860799|NCT00365105|FG001|Participant Flow|Zoledronic Acid + Radiopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
10860800|NCT00365105|OG000|Outcome|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
10860801|NCT00365105|OG001|Outcome|Zoledronic Acid + Radiopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
10860802|NCT00365105|EG000|Reported Event|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
10860803|NCT00365105|EG001|Reported Event|Zoledronic Acid + Radiopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
10860804|NCT00365144|BG000|Baseline|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
10860805|NCT00365144|FG000|Participant Flow|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
10860806|NCT00365144|OG000|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
10860807|NCT00365144|OG000|Outcome|Bevacizumab Plus Erlotinib Hydrochloride|"A treatment cycle is 21 days:~bevacizumab 15 mg/kg as a 60-90 min infusion once every 21 days, with erlotinib hydrochloride 150 mg by mouth daily~bevacizumab~erlotinib hydrochloride~laboratory biomarker analysis"
10860808|NCT00365144|EG000|Reported Event|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
10860809|NCT00365209|BG000|Baseline|Curcumin|"Stage 1: Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
10860810|NCT00365209|FG000|Participant Flow|Curcumin|"Stage 1: Particpants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Particpants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
10860811|NCT00365209|OG000|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
10860812|NCT00365209|EG000|Reported Event|Stage1 2 g Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
10860813|NCT00365209|EG001|Reported Event|Stage2 4 g Curcumin|"Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
10860814|NCT00365261|BG000|Baseline|Eszopiclone|receipt of active drug
10860815|NCT00365261|BG001|Baseline|Placebo|receipt of placebo
10860816|NCT00365261|BG002|Baseline|Total|Total of all reporting groups
10860817|NCT00365261|FG000|Participant Flow|Eszopiclone|receipt of active drug
10976968|NCT00942994|EG000|Reported Event|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
10860818|NCT00365261|FG001|Participant Flow|Placebo|receipt of placebo
10860819|NCT00365261|OG000|Outcome|Eszopiclone|active drug
10860820|NCT00365261|OG001|Outcome|Placebo|placebo
10860821|NCT00365261|OG000|Outcome|Eszopiclone|"active drug~Eszopiclone: eszopiclone 2 to 3 mg po at bedtime"
10860822|NCT00365261|OG001|Outcome|Placebo|"placebo~Placebo: placebo 2 to 3 mg po at bedtime"
10860823|NCT00365261|EG000|Reported Event|Eszopiclone|receipt of active drug
10860824|NCT00365261|EG001|Reported Event|Placebo|receipt of placebo
10860825|NCT00365274|BG000|Baseline|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
10860826|NCT00365274|FG000|Participant Flow|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
10860827|NCT00365274|OG000|Outcome|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
10976969|NCT00942994|EG001|Reported Event|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
10976970|NCT00943072|BG000|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
10976971|NCT00943072|BG001|Baseline|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
10976972|NCT00943072|BG002|Baseline|Total|Total of all reporting groups
10845672|NCT00268892|OG001|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10845673|NCT00268892|OG002|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10860828|NCT00365274|EG000|Reported Event|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
10860829|NCT00365300|BG000|Baseline|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
10860830|NCT00365300|BG001|Baseline|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
10860831|NCT00365300|BG002|Baseline|Total|Total of all reporting groups
10860832|NCT00365300|FG000|Participant Flow|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
10860833|NCT00365300|FG001|Participant Flow|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
10860834|NCT00365300|OG000|Outcome|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
10860835|NCT00365300|OG001|Outcome|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
10860836|NCT00365300|EG000|Reported Event|Screening|
10860837|NCT00365300|EG001|Reported Event|Pantoprazole Sodium Granules (Open-Label Phase)|
10860838|NCT00365300|EG002|Reported Event|Pantoprazole Sodium Granules (Double-blind Phase)|
10860839|NCT00365300|EG003|Reported Event|Placebo (Double-blind Phase)|
10860840|NCT00365300|EG004|Reported Event|Follow-up|
10860841|NCT00365352|BG000|Baseline|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
10860842|NCT00365352|BG001|Baseline|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
10860843|NCT00365352|BG002|Baseline|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
10860844|NCT00365352|BG003|Baseline|Total|Total of all reporting groups
10860845|NCT00365352|FG000|Participant Flow|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
10860846|NCT00365352|FG001|Participant Flow|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
11348630|NCT04152642|OG002|Outcome|Experimental Mouth Rinse|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.~Experimental Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
10860847|NCT00365352|FG002|Participant Flow|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
10860848|NCT00365352|OG000|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
10860849|NCT00365352|OG001|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
10860850|NCT00365352|OG001|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
10860851|NCT00365352|OG002|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
10860852|NCT00365352|OG001|Outcome|GEn (XP13512/GSK1838262) 600 Milligrams(mg) Taken Orally|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
10860853|NCT00365352|OG002|Outcome|GEn (XP13512/GSK1838262) 1200 mg Taken Orally Once a Day|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
10860854|NCT00365352|EG000|Reported Event|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
10860855|NCT00365352|EG001|Reported Event|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
10860856|NCT00365352|EG002|Reported Event|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
10860857|NCT00365365|BG000|Baseline|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860858|NCT00365365|BG001|Baseline|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860859|NCT00365365|BG002|Baseline|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860860|NCT00365365|BG003|Baseline|Total|Total of all reporting groups
10860861|NCT00365365|FG000|Participant Flow|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860862|NCT00365365|FG001|Participant Flow|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860863|NCT00365365|FG002|Participant Flow|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860864|NCT00365365|OG000|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860865|NCT00365365|OG001|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860866|NCT00365365|OG002|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860867|NCT00365365|EG000|Reported Event|AC->T + Bevacizumab|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860868|NCT00365365|EG001|Reported Event|TAC + Bevacizumab|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860869|NCT00365365|EG002|Reported Event|TCH + Bevacizumab|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
10860870|NCT00365378|BG000|Baseline|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
10860871|NCT00365378|BG001|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
10860872|NCT00365378|BG002|Baseline|Total|Total of all reporting groups
10860873|NCT00365378|FG000|Participant Flow|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
10860874|NCT00365378|FG001|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
10860875|NCT00365378|FG002|Participant Flow|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
10860876|NCT00365378|OG000|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
10860877|NCT00365378|OG001|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
10860878|NCT00365378|EG000|Reported Event|HPV 16 L1 VLP (Group 1)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
10860879|NCT00365378|EG001|Reported Event|Placebo (Group 2)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
10860880|NCT00365378|EG002|Reported Event|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
10860881|NCT00365391|BG000|Baseline|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
10860882|NCT00365391|FG000|Participant Flow|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine epidermal growth factor receptor (EGFR) and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by immuno-histochemistry (IHC) for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, mitogen-activated protein kinase (MAPK), and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
10860883|NCT00365391|OG000|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
10879013|NCT00454987|OG002|Outcome|Meningitec+Hiberix Group|"Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.~This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme."
10860884|NCT00365391|EG000|Reported Event|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
10860885|NCT00365417|BG000|Baseline|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
10860886|NCT00365417|FG000|Participant Flow|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
10860887|NCT00365417|OG000|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
10860888|NCT00365417|OG000|Outcome|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
10860889|NCT00365417|EG000|Reported Event|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
10860890|NCT00365456|BG000|Baseline|PTH(1-84) or Risedronate|"PTH(1-84) received by 405 participants in Trial Period I~of those 405 participants, 282 received Risedronate in Trial Period II~of those 282 participants, 268 participant remained and 136 received PTH(1-84) and 132 received Risedronate in Trial Period III"
10860891|NCT00365456|FG000|Participant Flow|PTH (1-84)|
10860892|NCT00365456|FG001|Participant Flow|Risedronate|
10860893|NCT00365456|OG000|Outcome|PTH (1-84)|Regimen 1 = PTH (1-84) → Risedronate → PTH (1-84)
10860894|NCT00365456|OG001|Outcome|Risedronate|Regimen 2 = PTH (1-84) → Risedronate → Risedronate
10860895|NCT00365456|EG000|Reported Event|PTH (1-84)|Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)
10860896|NCT00365456|EG001|Reported Event|Risedronate|Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
10860897|NCT00365508|BG000|Baseline|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
10860898|NCT00365508|BG001|Baseline|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
10860899|NCT00365508|BG002|Baseline|Total|Total of all reporting groups
10860900|NCT00365508|FG000|Participant Flow|Nicotine Patch|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
10860901|NCT00365508|FG001|Participant Flow|Nicotine Lozenge|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
10860902|NCT00365508|OG000|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
10860903|NCT00365508|OG001|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
10860904|NCT00365508|EG000|Reported Event|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
10860905|NCT00365508|EG001|Reported Event|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
10860906|NCT00365547|BG000|Baseline|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
10860907|NCT00365547|FG000|Participant Flow|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
10860908|NCT00365547|OG000|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab) given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
10860909|NCT00365547|OG000|Outcome|Patients Evaluable for Tumor Response|Only patients that remained in the study for at least 2 months and had the tumor measurements necessary to meet RECIST criteria are included.
10860910|NCT00365547|OG000|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
10860911|NCT00365547|OG000|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
10860912|NCT00365547|EG000|Reported Event|Safety Population|Patients who received treatment with weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
10860913|NCT00365599|BG000|Baseline|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
10860914|NCT00365599|FG000|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
10860915|NCT00365599|OG000|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
10860916|NCT00365599|EG000|Reported Event|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
10860917|NCT00365716|BG000|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860918|NCT00365716|BG001|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860919|NCT00365716|BG002|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860920|NCT00365716|BG003|Baseline|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860921|NCT00365716|BG004|Baseline|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860922|NCT00365716|BG005|Baseline|Total|Total of all reporting groups
10860923|NCT00365716|FG000|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860924|NCT00365716|FG001|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860925|NCT00365716|FG002|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860926|NCT00365716|FG003|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860927|NCT00365716|FG004|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860928|NCT00365716|FG005|Participant Flow|Extension 1|This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
10860929|NCT00365716|FG006|Participant Flow|Extension 2|This group includes 17 subjects from the United States, who received placebo during the base study and received 3 doses of qHPV vaccine during the Extension, or received less than 3 doses of the qHPV Vaccine during the base study and completed the dose regimen during the Extension.
10860930|NCT00365716|OG000|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860931|NCT00365716|OG001|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860932|NCT00365716|OG002|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860933|NCT00365716|OG003|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860934|NCT00365716|OG004|Outcome|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860935|NCT00365716|OG001|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225 or 450 Combined|For the purposes of this outcome measure, the placebo groups (225 mcg and 450 mcg) were combined.
10860936|NCT00365716|EG000|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.~There was one subject randomized to the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine 20/40/40/20 mcg group who received the 225 mcg aluminum adjuvant placebo at the third vaccination visit. This subject was not included in the counts reported in the Adverse Event tables. No SAEs were reported for this subject.~There was 1 patient that was randomized, but never vaccinated. As such, that patient is not included in this table."
10860937|NCT00365716|EG001|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.~There were 2 patients from the 40/40/40/40 group that were randomized, but were never vaccinated. As such, these 2 patients are not included in this table."
10860938|NCT00365716|EG002|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860939|NCT00365716|EG003|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860940|NCT00365716|EG004|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
10860941|NCT00365716|EG005|Reported Event|Extensions|"This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.~Serious Adverse Events (SAEs) were collected during Extension 1 and Extension 2. Note that the N includes only the 241 subjects vaccinated during the Extension Periods; of the 258 subjects that entered either Extension, 17 subjects discontinued before being vaccinated and therefore are not included in this table."
10860942|NCT00365768|BG000|Baseline|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
10860943|NCT00365768|BG001|Baseline|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
10860944|NCT00365768|BG002|Baseline|Total|Total of all reporting groups
10860945|NCT00365768|FG000|Participant Flow|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
10860946|NCT00365768|FG001|Participant Flow|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
10860947|NCT00365768|OG000|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
10860948|NCT00365768|OG001|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
10860949|NCT00365768|EG000|Reported Event|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
10860950|NCT00365768|EG001|Reported Event|Arm II|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
10860951|NCT00365794|BG000|Baseline|Single Arm|open label treatment with testosterone gel
10860952|NCT00365794|FG000|Participant Flow|Single Arm|"Open label treatment with each participant serving as his own control. Data is compared before and after treatment.~Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks"
10860953|NCT00365794|OG000|Outcome|Single Arm|"Open label treatment with each participant serving as his own control. Data is compared before and after treatment.~Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks"
10860954|NCT00365794|OG000|Outcome|Single Arm|"Open label treatment without masking with each participant serving as his own control. Measurements are compared before and after treatment.~Topical testosterone gel 10 g/day: Testosterone gel therapy for 20 weeks"
10860955|NCT00365794|EG000|Reported Event|Open Label Testosterone Treatment|"No serious adverse events occurred~PSA and Framingham CV Disease Risk Score did not increase"
10860956|NCT00365846|BG000|Baseline|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
10860957|NCT00365846|FG000|Participant Flow|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
10860958|NCT00365846|OG000|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
10860959|NCT00365846|OG000|Outcome|Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction on Day -1 and 0 of renal transplant followed w/ Sirolimus maintenance immunosuppression
10860960|NCT00365846|OG000|Outcome|Group 1Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction w/ Sirolimus immunosuppression
10860961|NCT00365846|EG000|Reported Event|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
10860962|NCT00365859|BG000|Baseline|De Novo|As previously described in Participant Flow
10860963|NCT00365859|BG001|Baseline|Rollover Placebo|As previously described in Participant Flow
10860964|NCT00365859|BG002|Baseline|Rollover Aripiprazole|As previously described in Participant Flow
10860965|NCT00365859|BG003|Baseline|Total|Total of all reporting groups
10860966|NCT00365859|FG000|Participant Flow|De Novo|De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
10860967|NCT00365859|FG001|Participant Flow|Rollover Placebo|Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
10879014|NCT00454987|EG000|Reported Event|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
10879015|NCT00454987|EG001|Reported Event|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
10860968|NCT00365859|FG002|Participant Flow|Rollover Aripiprazole|Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
10860969|NCT00365859|FG003|Participant Flow|Total|
10860970|NCT00365859|OG000|Outcome|De Novo|As previously described in Participant Flow
10860971|NCT00365859|OG001|Outcome|Rollover Placebo|As previously described in Participant Flow
10860972|NCT00365859|OG002|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
10860973|NCT00365859|OG003|Outcome|Total|
10860974|NCT00365859|EG000|Reported Event|De Novo|
10860975|NCT00365859|EG001|Reported Event|Roll Over Aripiprazole|
10860976|NCT00365859|EG002|Reported Event|Roll Over Placebo|
10860977|NCT00365872|BG000|Baseline|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
10860978|NCT00365872|BG001|Baseline|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
10860979|NCT00365872|BG002|Baseline|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
10860980|NCT00365872|BG003|Baseline|Total|Total of all reporting groups
10860981|NCT00365872|FG000|Participant Flow|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
10860982|NCT00365872|FG001|Participant Flow|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
10860983|NCT00365872|FG002|Participant Flow|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
10860984|NCT00365872|OG000|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
11348631|NCT04152642|EG000|Reported Event|Water/Negative Control|"subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4.~Water control: negative control"
11348632|NCT04152642|EG001|Reported Event|Marketed Mouth Rinse|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.~Marketed Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11348633|NCT04152642|EG002|Reported Event|Experimental Mouth Rinse|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.~Experimental Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11348634|NCT04150861|BG000|Baseline|Follitropin Delta (FE 999049) 12 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
10976973|NCT00943072|FG000|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.~Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
10976974|NCT00943072|FG001|Participant Flow|Sham Treatment|"Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.~Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
10976975|NCT00943072|OG000|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
10976976|NCT00943072|OG001|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
10976977|NCT00943072|EG000|Reported Event|Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24.~Participants in the safety population were at risk."
10976978|NCT00943072|EG001|Reported Event|Sham Treatment (Baseline to Week 24)|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
10976979|NCT00943072|EG002|Reported Event|IAI to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
10976980|NCT00943072|EG003|Reported Event|Sham Treatment to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
10976981|NCT00943098|BG000|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
10860985|NCT00365872|OG000|Outcome|Single Arm - Cohort 1|DC injection # 4 given 24 hours prior to surgery
10860986|NCT00365872|OG001|Outcome|Single Arm - Cohort 2|DC injection # 4 given 48 hours prior to surgery
10860987|NCT00365872|OG002|Outcome|Single Arm - Cohort 3|DC injection # 4 given 72 hours prior to surgery
10860988|NCT00365872|EG000|Reported Event|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
10860989|NCT00365976|BG000|Baseline|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
10860990|NCT00365976|BG001|Baseline|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
10860991|NCT00365976|BG002|Baseline|Total|Total of all reporting groups
10860992|NCT00365976|FG000|Participant Flow|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
10860993|NCT00365976|FG001|Participant Flow|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
10860994|NCT00365976|OG000|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
10860995|NCT00365976|OG001|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
10860996|NCT00365976|EG000|Reported Event|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
10860997|NCT00365976|EG001|Reported Event|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
10860998|NCT00365989|BG000|Baseline|Enhanced Sonication Test Arm|ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
10860999|NCT00365989|FG000|Participant Flow|Enhanced Sonication Test Arm|ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
10861000|NCT00365989|OG000|Outcome|Enhanced Sonication Test Arm|ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
10861001|NCT00365989|OG000|Outcome|ExAblate Enhanced Sonication Test Arm|"The intervention to be administered is ExAblate Enhanced Sonication. The purpose of this study is to examine the safety profile of the ExAblate Enhanced Sonication mode to insure that no new safety issues are introduced compared to the normal focused ultrasound mode.~ExAblate Enhanced Sonication"
10861002|NCT00365989|EG000|Reported Event|Enhanced Sonication Test Arm|ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
10976982|NCT00943098|BG001|Baseline|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
10976983|NCT00943098|BG002|Baseline|Total|Total of all reporting groups
10976984|NCT00943098|FG000|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
10976985|NCT00943098|FG001|Participant Flow|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
10976986|NCT00943098|OG000|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
10976987|NCT00943098|OG001|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
10976988|NCT00943098|EG000|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
10976989|NCT00943098|EG001|Reported Event|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
10976990|NCT00943111|BG000|Baseline|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
10976991|NCT00943111|BG001|Baseline|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
10976992|NCT00943111|BG002|Baseline|Total|Total of all reporting groups
10976993|NCT00943111|FG000|Participant Flow|Eliglustat: PAP|Eliglustat tartrate (Genz-112638) capsule 50 milligram (mg) twice daily (BID) orally from Day 1 to Week 4 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 8, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 52. The dose adjustments after Week 4 and Week 8 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was less than [<] 5 nanogram per milliliter [ng/mL] the next higher dose was administered whereas if the Genz-99067 trough plasma concentration was greater than or equal to [>=] 5 ng/mL the same dose was continued. The pharmacokinetic (PK) assessment at Week 2 and Week 6 were used for dose adjustment after Week 4 and Week 8, respectively.
10976994|NCT00943111|FG001|Participant Flow|Imiglucerase: PAP|Imiglucerase (Cerezyme®) intravenous infusion every other week (q2w) up to Week 52 in doses equivalent to participant's past enzyme replacement therapy (ERT) dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
10976995|NCT00943111|FG002|Participant Flow|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was <5 ng/mL next higher dose was administered whereas if the Genz-99067 trough plasma concentration was >=5 ng/mL the same dose was continued. PK assessment at Week 54 and Week 58 were used for dose adjustment after Week 56 and Week 60, respectively."
10976996|NCT00943111|OG000|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
10976997|NCT00943111|OG001|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
10976998|NCT00943111|OG000|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
10976999|NCT00943111|EG000|Reported Event|Eliglustat|PAP: Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52. Dose adjustments after Week 4 and Week 8 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. LTTP: Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
10977000|NCT00943111|EG001|Reported Event|Imiglucerase|PAP: Imiglucerase (Cerezyme®) intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change. LTTP: Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations.
10977001|NCT00943124|BG000|Baseline|Overall Study Population|All randomized patients
10977002|NCT00943124|FG000|Participant Flow|MK0524B Then Simvastatin + MK0524A|"Period 1: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet).~Period 2: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets."
11126360|NCT01732874|FG000|Participant Flow|Expecta 200 mg|"Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.~Expecta 200 mg: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU."
11348635|NCT04150861|BG001|Baseline|Follitropin Delta (FE 999049) 18 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
10977003|NCT00943124|FG001|Participant Flow|Simvastatin + MK0524A Then MK0524B|"Period 1: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets.~Period 2: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet)."
10977004|NCT00943124|OG000|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
10977005|NCT00943124|OG001|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
10977006|NCT00943124|EG000|Reported Event|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
10977007|NCT00943124|EG001|Reported Event|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
10977008|NCT00943150|BG000|Baseline|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
10977009|NCT00943150|BG001|Baseline|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
10977010|NCT00943150|BG002|Baseline|Total|Total of all reporting groups
10977011|NCT00943150|FG000|Participant Flow|PEAK PlasmaBlade|The PEAK PlasmaBlade for the abdominoplasty procedure.
10977012|NCT00943150|FG001|Participant Flow|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
10977013|NCT00943150|OG000|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
10977014|NCT00943150|OG001|Outcome|Electrocautery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
10977015|NCT00943150|OG001|Outcome|Electrosurgery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
10977016|NCT00943150|OG002|Outcome|Scalpel|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
10977017|NCT00943150|OG000|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
10977018|NCT00943150|OG001|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
10977019|NCT00943150|EG000|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
10977020|NCT00943150|EG001|Reported Event|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
10977021|NCT00943202|BG000|Baseline|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977022|NCT00943202|BG001|Baseline|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
10977023|NCT00943202|BG002|Baseline|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
10977024|NCT00943202|BG003|Baseline|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
10977025|NCT00943202|BG004|Baseline|Total|Total of all reporting groups
10977026|NCT00943202|FG000|Participant Flow|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977027|NCT00943202|FG001|Participant Flow|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
10977028|NCT00943202|FG002|Participant Flow|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
10977029|NCT00943202|FG003|Participant Flow|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
10977030|NCT00943202|OG000|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977031|NCT00943202|OG001|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
10977032|NCT00943202|OG002|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
10977033|NCT00943202|OG003|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
10977034|NCT00943202|OG001|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
10977035|NCT00943202|EG000|Reported Event|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977036|NCT00943202|EG001|Reported Event|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
10977037|NCT00943202|EG002|Reported Event|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
10977038|NCT00943202|EG003|Reported Event|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
10861003|NCT00366028|BG000|Baseline|Organizational Model|"Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
10861004|NCT00366028|BG001|Baseline|Data Feedback|"Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Only Model: The research team will periodically interview the facilities and provide them with reported hand hygiene data."
10861005|NCT00366028|BG002|Baseline|Total|Total of all reporting groups
10861006|NCT00366028|FG000|Participant Flow|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two."
10861007|NCT00366028|FG001|Participant Flow|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
10861008|NCT00366028|OG000|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~The Intervention Arm included 889 individual participants across 7 study sites (medical centers)."
10861009|NCT00366028|OG001|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.~The Control Arm included 735 individual participants across 9 study sites (medical centers) in total. Only 5 of the study sites are included in the reporting of outcome data due to incomplete data at 4 of the study sites."
10861010|NCT00366028|OG000|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~The Intervention Arm included 7 study sites (medical centers). Of the 7 sites there were 4 with high fidelity to the Organizational Model and 3 with low fidelity to the Organizational Model."
10861011|NCT00366028|OG001|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.~The Control Arm included 9 study sites (medical centers) in total. Only 5 of the study sites are included in analysis of this outcome measure due to incomplete hand hygiene data at 4 of the study sites. Of the 5 study sites included, there were 2 sites with high fidelity to the Organization Model and 3 sites with low fidelity to the Organizational model, even though the model was not specifically introduced to the control arm."
10861012|NCT00366028|EG000|Reported Event|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
10861013|NCT00366028|EG001|Reported Event|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
10861014|NCT00366106|BG000|Baseline|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
10861015|NCT00366106|FG000|Participant Flow|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
10861016|NCT00366106|OG000|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
11348636|NCT04150861|BG002|Baseline|Follitropin Delta (FE 999049) 24 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
10861017|NCT00366106|EG000|Reported Event|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
10861018|NCT00366249|BG000|Baseline|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
10861019|NCT00366249|BG001|Baseline|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
10861020|NCT00366249|BG002|Baseline|Total|Total of all reporting groups
11348637|NCT04150861|BG003|Baseline|Total|Total of all reporting groups
11348638|NCT04150861|FG000|Participant Flow|Follitropin Delta (FE 999049) 12 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
11348639|NCT04150861|FG001|Participant Flow|Follitropin Delta (FE 999049) 18 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
11348640|NCT04150861|FG002|Participant Flow|Follitropin Delta (FE 999049) 24 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
11348641|NCT04150861|OG000|Outcome|Follitropin Delta (FE 999049) 12 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
11348642|NCT04150861|OG001|Outcome|Follitropin Delta (FE 999049) 18 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
11348643|NCT04150861|OG002|Outcome|Follitropin Delta (FE 999049) 24 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
11348644|NCT04150861|EG000|Reported Event|Follitropin Delta (FE 999049) 12 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
11348645|NCT04150861|EG001|Reported Event|Follitropin Delta (FE 999049) 18 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
11348646|NCT04150861|EG002|Reported Event|Follitropin Delta (FE 999049) 24 μg|Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
11348647|NCT04150250|BG000|Baseline|iOWH032|On Day 1, participants were challenged with 10^6 CFU of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
11348648|NCT04150250|BG001|Baseline|Placebo|On Day 1, participants were challenged with 10^6 CFU of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
11348649|NCT04150250|BG002|Baseline|Total|Total of all reporting groups
11348650|NCT04150250|FG000|Participant Flow|iOWH032|On Day 1, participants were challenged with 10^6 colony-forming units (CFU) of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
11348651|NCT04150250|FG001|Participant Flow|Placebo|On Day 1, participants were challenged with 10^6 CFU of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
11348652|NCT04150250|OG000|Outcome|iOWH032|On Day 1, participants were challenged with 10^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
11348653|NCT04150250|OG001|Outcome|Placebo|On Day 1, participants were challenged with 10^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
11348654|NCT04150250|EG000|Reported Event|iOWH032|On Day 1, participants were challenged with 10^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
11348655|NCT04150250|EG001|Reported Event|Placebo|On Day 1, participants were challenged with 10^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
11348656|NCT04149925|BG000|Baseline|AEON Endostapler|"Stapling performed by AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
11348657|NCT04149925|BG001|Baseline|Echelon Flex Powered Stapler|"Stapling performed by Echelon Flex Powered Stapler~Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler"
11348658|NCT04149925|BG002|Baseline|Total|Total of all reporting groups
10861021|NCT00366249|FG000|Participant Flow|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
10861022|NCT00366249|FG001|Participant Flow|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
10861023|NCT00366249|OG000|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
10861024|NCT00366249|OG001|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
10861025|NCT00366249|EG000|Reported Event|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
10861026|NCT00366249|EG001|Reported Event|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
10861027|NCT00366275|BG000|Baseline|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
10977039|NCT00943306|BG000|Baseline|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
10977040|NCT00943306|FG000|Participant Flow|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
10861028|NCT00366275|FG000|Participant Flow|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
10861029|NCT00366275|OG000|Outcome|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
10861030|NCT00366275|EG000|Reported Event|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
10861031|NCT00366301|BG000|Baseline|Placebo Pill|Placebo pill
10861032|NCT00366301|BG001|Baseline|Metformin Pill|Metformin pill
10861033|NCT00366301|BG002|Baseline|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
10861034|NCT00366301|BG003|Baseline|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
10861035|NCT00366301|BG004|Baseline|Total|Total of all reporting groups
10861036|NCT00366301|FG000|Participant Flow|Placebo Pill|Placebo pill
10861037|NCT00366301|FG001|Participant Flow|Metformin Pill|Metformin pill
10861038|NCT00366301|FG002|Participant Flow|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
10861039|NCT00366301|FG003|Participant Flow|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
10861040|NCT00366301|OG000|Outcome|Placebo Pill|Placebo pill
10861041|NCT00366301|OG001|Outcome|Metformin Pill|Metformin pill
10861042|NCT00366301|OG002|Outcome|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
10861043|NCT00366301|OG003|Outcome|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
10861044|NCT00366301|EG000|Reported Event|Placebo Pill|Placebo pill
10861045|NCT00366301|EG001|Reported Event|Metformin Pill|Metformin pill
10861046|NCT00366301|EG002|Reported Event|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
10861047|NCT00366301|EG003|Reported Event|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
10861048|NCT00366340|BG000|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
10861049|NCT00366340|BG001|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
10861050|NCT00366340|BG002|Baseline|Total|Total of all reporting groups
10861051|NCT00366340|FG000|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
10861052|NCT00366340|FG001|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
10861053|NCT00366340|OG000|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
10861054|NCT00366340|OG001|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
10861055|NCT00366340|OG000|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
10861056|NCT00366340|OG001|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
11348659|NCT04149925|FG000|Participant Flow|AEON Endostapler|"Stapling performed by AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
10861057|NCT00366340|OG002|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
10861058|NCT00366340|OG003|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
10861059|NCT00366340|OG002|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
10861060|NCT00366340|OG003|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
10861061|NCT00366340|OG000|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
10861062|NCT00366340|OG001|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
10861063|NCT00366340|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
10861064|NCT00366340|OG001|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
10861065|NCT00366340|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
10861066|NCT00366340|OG003|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
10861067|NCT00366340|OG004|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
10861068|NCT00366340|OG005|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
10861069|NCT00366340|OG006|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
10861070|NCT00366340|OG007|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
10861071|NCT00366340|OG000|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
10861072|NCT00366340|OG001|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
10861073|NCT00366340|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
10861074|NCT00366340|EG001|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
10861075|NCT00366340|EG002|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.
10861076|NCT00366340|EG003|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.
10861077|NCT00366340|EG004|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
10861078|NCT00366340|EG005|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
10861079|NCT00366340|EG006|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
10861080|NCT00366340|EG007|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
10861081|NCT00366444|BG000|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
10861082|NCT00366444|BG001|Baseline|Placebo|Oral placebo capsule, every 6 hours
10861083|NCT00366444|BG002|Baseline|Total|Total of all reporting groups
10861084|NCT00366444|FG000|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
10861085|NCT00366444|FG001|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
10861086|NCT00366444|OG000|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
10861087|NCT00366444|OG001|Outcome|Placebo|Oral placebo capsule, every 6 hours
10861088|NCT00366444|EG000|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
10861089|NCT00366444|EG001|Reported Event|Placebo|Oral placebo capsule, every 6 hours
10861090|NCT00366457|BG000|Baseline|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
10861091|NCT00366457|FG000|Participant Flow|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
10861092|NCT00366457|OG000|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
10861093|NCT00366457|EG000|Reported Event|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
10861094|NCT00366535|BG000|Baseline|Placebo First, Then Neurotropin (G-1)|Double blind cross-over study: receive Placebo (4 tabs, b.i.d.) for 12 weeks and then Neurotropin (4 tabs, b.i.d.) for 12 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind.
10861095|NCT00366535|BG001|Baseline|Neurotropin First, Then Placebo (G-2)|Double blind cross-over study: receive Neurotropin (4 tabs, b.i.d.) for 12 weeks and then Placebo (4 tabs, b.i.d.) for 12 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind.
10861096|NCT00366535|BG002|Baseline|Total|Total of all reporting groups
10861097|NCT00366535|FG000|Participant Flow|Study Drug A Then Study Drug B (G-1)|Double blind cross-over study: received Placebo (4 tabs, b.i.d.) for 12 weeks and then Neurotropin (4 tabs, b.i.d.) for 12 weeks (after at least 1 week washout period). Assignment to each group was randomized by the NIH Clinical Center pharmacy. Study team and participants were all blinded.
10861098|NCT00366535|FG001|Participant Flow|Study Drug B First, Then Study Drug A (G-2)|Double blind cross-over study: received Study drug B (4 tabs, b.i.d.) for 12 weeks and then Study drug A (4 tabs, b.i.d.) for 12 weeks (after at least 1 week washout period). Assignment to each group was randomized by the NIH CC pharmacy. Study team and participants were blinded.
10861099|NCT00366535|OG000|Outcome|FIQ Before Placebo Treatment First in G-1|FIQ of this group was determined before the 12 week-treatment with Placebo.
10861100|NCT00366535|OG001|Outcome|FIQ After Placebo Treatment First in G-1|This group received Placebo 4 tabs b.i.d. for 12 weeks first. FIQ was determined at the end of the 12 week-treatment with Placebo.
10861101|NCT00366535|OG002|Outcome|FIQ Before Neurotropin Treatment Second in G-1|FIQ of this group was determined before the 12 week-treatment with Neurotropin.
10861102|NCT00366535|OG003|Outcome|FIQ After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 12 weeks after at least 1 week washout period following the first 12 week interval on placebo. FIQ was determined at the end of the 12 week-treatment with Neurotropin."
10861103|NCT00366535|OG004|Outcome|FIQ Before Neurotropin Treatment First in G-2|FIQ of this group was determined before the 12 week-treatment with Neurotropin.
10861104|NCT00366535|OG005|Outcome|FIQ After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 12 weeks first. FIQ was determined at the end of the 12 week-treatment with Placebo.
10861105|NCT00366535|OG006|Outcome|FIQ Before Placebo Treatment Second in G-2|FIQ of this group was determined before the 12 week-treatment with Placebo.
10861106|NCT00366535|OG007|Outcome|FIQ After Placebo Treatment Second in G-2|"This group received Placebo 4 tabs b.i.d. for 12 weeks after at least 1 week washout period following the first 12 week interval on placebo. FIQ was determined at the end of the 12 week-treatment with Placebo."
10861107|NCT00366535|EG000|Reported Event|Placebo Treatment First in G-1|This group received Placebo 4 tabs b.i.d. for the first 12 weeks.
10861108|NCT00366535|EG001|Reported Event|Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 12 weeks after at least 1 week washout period following the first 12 week interval on Placebo."
10861109|NCT00366535|EG002|Reported Event|Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for the first 12 weeks.
10861110|NCT00366535|EG003|Reported Event|Placebo Treatment Second in G-2|"This group received Placebo 4 tabs b.i.d. for 12 weeks after at least 1 week washout period following the first 12 week interval on Neurotropin."
10861111|NCT00366548|BG000|Baseline|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
10861112|NCT00366548|BG001|Baseline|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
10861113|NCT00366548|BG002|Baseline|Total|Total of all reporting groups
10861114|NCT00366548|FG000|Participant Flow|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
10861115|NCT00366548|FG001|Participant Flow|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
10861116|NCT00366548|OG000|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861117|NCT00366548|OG001|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861118|NCT00366548|OG000|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
10861119|NCT00366548|OG001|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
10861120|NCT00366548|OG000|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
10861121|NCT00366548|OG001|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
10861122|NCT00366548|OG002|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
10861123|NCT00366548|OG003|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
10861124|NCT00366548|OG004|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
10861125|NCT00366548|OG005|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
10861126|NCT00366548|OG006|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
10861127|NCT00366548|OG007|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
10861128|NCT00366548|OG006|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861129|NCT00366548|OG007|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861130|NCT00366548|EG000|Reported Event|13vPnC + P80 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861131|NCT00366548|EG001|Reported Event|13vPnC - P 80 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861132|NCT00366548|EG002|Reported Event|13vPnC + P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861133|NCT00366548|EG003|Reported Event|13vPnC - P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861134|NCT00366548|EG004|Reported Event|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861135|NCT00366548|EG005|Reported Event|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861136|NCT00366548|EG006|Reported Event|13vPnC + P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861137|NCT00366548|EG007|Reported Event|13vPnC - P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
10861138|NCT00366626|BG000|Baseline|Naltrexone|
10861139|NCT00366626|BG001|Baseline|Placebo|
10861140|NCT00366626|BG002|Baseline|Total|Total of all reporting groups
10861141|NCT00366626|FG000|Participant Flow|Naltrexone|
10861142|NCT00366626|FG001|Participant Flow|Placebo|
10861143|NCT00366626|OG000|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
10861144|NCT00366626|OG001|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
10861145|NCT00366626|OG002|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
10861146|NCT00366626|OG003|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
10861147|NCT00366626|EG000|Reported Event|Naltrexone|
10861148|NCT00366626|EG001|Reported Event|Placebo|
10861149|NCT00366678|BG000|Baseline|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861150|NCT00366678|BG001|Baseline|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861151|NCT00366678|BG002|Baseline|Total|Total of all reporting groups
10861152|NCT00366678|FG000|Participant Flow|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861153|NCT00366678|FG001|Participant Flow|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861154|NCT00366678|FG002|Participant Flow|7vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
10861155|NCT00366678|OG000|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861156|NCT00366678|OG001|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861157|NCT00366678|OG002|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861158|NCT00366678|OG003|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861159|NCT00366678|OG000|Outcome|13vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861160|NCT00366678|OG001|Outcome|7vPnC Infant Series / 7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861161|NCT00366678|OG002|Outcome|7vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
10861162|NCT00366678|OG000|Outcome|13vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861163|NCT00366678|OG001|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
10861164|NCT00366678|OG002|Outcome|7vPnC/7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861165|NCT00366678|OG003|Outcome|7vPnC/7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
10861166|NCT00366678|OG004|Outcome|7vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
10861167|NCT00366678|OG005|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
10861168|NCT00366678|OG000|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
10861169|NCT00366678|OG001|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
10861170|NCT00366678|OG000|Outcome|13vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, 4, and 12 months of age.
10861171|NCT00366678|OG001|Outcome|7vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
10861172|NCT00366678|OG000|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
10861173|NCT00366678|OG001|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
10861174|NCT00366678|OG002|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
10861175|NCT00366678|OG003|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
10861176|NCT00366678|OG000|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
10861177|NCT00366678|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
10861178|NCT00366678|OG001|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
10861179|NCT00366678|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
10861180|NCT00366678|OG003|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
10861181|NCT00366678|OG004|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
10861182|NCT00366678|OG005|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
10861183|NCT00366678|OG006|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
10861184|NCT00366678|OG007|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
10861185|NCT00366678|OG008|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
10861186|NCT00366678|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
10861187|NCT00366678|OG008|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
10861188|NCT00366678|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
10861189|NCT00366678|EG001|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
10861190|NCT00366678|EG002|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
10861191|NCT00366678|EG003|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
10861192|NCT00366678|EG004|Reported Event|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
10861193|NCT00366678|EG005|Reported Event|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
10861194|NCT00366678|EG006|Reported Event|7vPnC/ 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
10861195|NCT00366678|EG007|Reported Event|13vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
10861196|NCT00366678|EG008|Reported Event|7vPnC / 7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
10861197|NCT00366678|EG009|Reported Event|7vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
10861198|NCT00366899|BG000|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
10861199|NCT00366899|BG001|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
10861200|NCT00366899|BG002|Baseline|Total|Total of all reporting groups
10861201|NCT00366899|FG000|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
10861202|NCT00366899|FG001|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
10861203|NCT00366899|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
10861204|NCT00366899|OG001|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
10861205|NCT00366899|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
10861206|NCT00366899|OG003|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
10861207|NCT00366899|OG004|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
10861208|NCT00366899|OG005|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
10861209|NCT00366899|OG000|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
10861210|NCT00366899|OG001|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
10861211|NCT00366899|OG002|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861212|NCT00366899|OG003|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861213|NCT00366899|OG000|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
10861214|NCT00366899|OG001|Outcome|7vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
10861215|NCT00366899|OG002|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861216|NCT00366899|OG003|Outcome|7vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861217|NCT00366899|OG001|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861218|NCT00366899|OG002|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861219|NCT00366899|OG003|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861220|NCT00366899|OG001|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861221|NCT00366899|OG000|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861222|NCT00366899|OG001|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
10861223|NCT00366899|OG000|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
10861224|NCT00366899|OG001|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
10861225|NCT00366899|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
10861226|NCT00366899|EG001|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
10861227|NCT00366899|EG002|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
10861228|NCT00366899|EG003|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
10861229|NCT00366899|EG004|Reported Event|13vPnC Toddler Series|Participants received one single 0.5mL dose of 13vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
10861230|NCT00366899|EG005|Reported Event|7vPnC Toddler Series|Participants received one single 0.5mL dose of 7vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
10861231|NCT00366899|EG006|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
10861232|NCT00366899|EG007|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
10861233|NCT00367003|BG000|Baseline|Deep Brain Stimulation|"Participants with treatment resistant depression will have a device implanted for deep brain stimulation.~Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary."
10861234|NCT00367003|FG000|Participant Flow|Deep Brain Stimulation|"Participants with treatment resistant depression will have a device implanted for deep brain stimulation.~Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary."
10861235|NCT00367003|OG000|Outcome|Deep Brain Stimulation|"Participants with treatment resistant depression will have a device implanted for deep brain stimulation.~Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary."
10861236|NCT00367003|EG000|Reported Event|Deep Brain Stimulation|"Participants with treatment resistant depression will have a device implanted for deep brain stimulation.~Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary."
10861237|NCT00367016|BG000|Baseline|Omalizumab|Subjects will receive subcutaneous Omalizumab for 6 months. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
10861238|NCT00367016|BG001|Baseline|Placebo|Subjects will receive subcutaneous placebo for 6 months. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
10861239|NCT00367016|BG002|Baseline|Total|Total of all reporting groups
10861240|NCT00367016|FG000|Participant Flow|Omalizumab|Subjects will receive subcutaneous Omalizumab for 6 months. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
10861241|NCT00367016|FG001|Participant Flow|Placebo|Subjects will receive subcutaneous placebo for 6 months. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
10861242|NCT00367016|OG000|Outcome|Omalizumab|The subjects will be randomized to a treatment group and a placebo group. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens.
10861243|NCT00367016|OG001|Outcome|Placebo|The subjects will be randomized to a treatment group and a placebo group. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens.
10861244|NCT00367016|OG000|Outcome|Omalizumab|Subjects will receive subcutaneous Omalizumab for 6 months. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
10861245|NCT00367016|OG001|Outcome|Placebo|Subjects will receive subcutaneous placebo for 6 months. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
10861246|NCT00367016|EG000|Reported Event|Omalizumab|Subjects will receive subcutaneous Omalizumab for 6 months. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
10861247|NCT00367016|EG001|Reported Event|Placebo|Subjects will receive subcutaneous placebo for 6 months. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
10861248|NCT00367055|BG000|Baseline|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
10861249|NCT00367055|BG001|Baseline|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
10861250|NCT00367055|BG002|Baseline|Total|Total of all reporting groups
10861251|NCT00367055|FG000|Participant Flow|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
10861252|NCT00367055|FG001|Participant Flow|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
10861253|NCT00367055|OG000|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
10861254|NCT00367055|OG001|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
10861255|NCT00367055|EG000|Reported Event|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
10861256|NCT00367055|EG001|Reported Event|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
10861257|NCT00367133|BG000|Baseline|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
10861258|NCT00367133|BG001|Baseline|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
10861259|NCT00367133|BG002|Baseline|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
10861260|NCT00367133|BG003|Baseline|Total|Total of all reporting groups
10861261|NCT00367133|FG000|Participant Flow|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
10861262|NCT00367133|FG001|Participant Flow|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
10861263|NCT00367133|FG002|Participant Flow|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
10861264|NCT00367133|OG000|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
10861265|NCT00367133|OG001|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
10861266|NCT00367133|OG002|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
10861267|NCT00367133|EG000|Reported Event|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
10861268|NCT00367133|EG001|Reported Event|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
10861269|NCT00367133|EG002|Reported Event|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
10861270|NCT00367237|BG000|Baseline|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
10861271|NCT00367237|BG001|Baseline|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
10861272|NCT00367237|BG002|Baseline|Total|Total of all reporting groups
10861273|NCT00367237|FG000|Participant Flow|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
10861274|NCT00367237|FG001|Participant Flow|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
10861275|NCT00367237|OG000|Outcome|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
10861276|NCT00367237|OG001|Outcome|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
10861277|NCT00367237|EG000|Reported Event|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
10861278|NCT00367237|EG001|Reported Event|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
10861279|NCT00367341|BG000|Baseline|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
10861280|NCT00367341|BG001|Baseline|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
10861281|NCT00367341|BG002|Baseline|Total|Total of all reporting groups
10861282|NCT00367341|FG000|Participant Flow|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
10861283|NCT00367341|FG001|Participant Flow|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
10861284|NCT00367341|OG000|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
10861285|NCT00367341|OG001|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
10861286|NCT00367341|EG000|Reported Event|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
10861287|NCT00367341|EG001|Reported Event|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
10861288|NCT00367380|BG000|Baseline|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
10861289|NCT00367380|BG001|Baseline|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
10861290|NCT00367380|BG002|Baseline|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
10861291|NCT00367380|BG003|Baseline|Total|Total of all reporting groups
10861292|NCT00367380|FG000|Participant Flow|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
10861293|NCT00367380|FG001|Participant Flow|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
10861294|NCT00367380|FG002|Participant Flow|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
10861295|NCT00367380|OG000|Outcome|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
10861296|NCT00367380|OG001|Outcome|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
10861297|NCT00367380|OG002|Outcome|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
10861298|NCT00367380|EG000|Reported Event|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
10861299|NCT00367380|EG001|Reported Event|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
10861300|NCT00367380|EG002|Reported Event|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
10861301|NCT00367432|BG000|Baseline|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
10861302|NCT00367432|FG000|Participant Flow|Levetiracetam N01221 [NCT00280696]|N01221 [NCT00280696] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam.
10861303|NCT00367432|FG001|Participant Flow|Levetiracetam N01020 [NCT00160615]|N01020 [NCT00160615] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.
10861304|NCT00367432|OG000|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
10861305|NCT00367432|EG000|Reported Event|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
10861306|NCT00367458|BG000|Baseline|Atorvastatin First, Then Placebo|Patients were randomized to receive Atorvastatin first for 8 weeks, followed by 4 weeks wash out, and then cross over to placebo for 8 weeks.
10861307|NCT00367458|BG001|Baseline|Placebo First, Then Atorvastatin|Patients were randomized to receive placebo first for 8 weeks, followed by 4 weeks wash out, and then cross over to 80 mg atorvastatin daily for 8 weeks.
10861308|NCT00367458|BG002|Baseline|Total|Total of all reporting groups
10861309|NCT00367458|FG000|Participant Flow|Atorvastatin First, Then Placebo|Patients were randomized to receive Atorvastatin first for 8 weeks, followed by 4 weeks wash out, and then cross over to placebo for 8 weeks.
10861310|NCT00367458|FG001|Participant Flow|Placebo First, Then Atorvastatin|Patients were randomized to receive placebo first for 8 weeks, followed by 4 weeks wash out, and then cross over to 80 mg atorvastatin daily for 8 weeks.
10861311|NCT00367458|OG000|Outcome|Atorvastatin|Patients were randomized to receive Atorvastatin for 8 weeks
10861312|NCT00367458|OG001|Outcome|Placebo|Patients were randomized to receive placebo for 8 weeks
10861313|NCT00367458|EG000|Reported Event|Atorvastatin|Patients were randomized to receive Atorvastatin for 8 weeks
10861314|NCT00367458|EG001|Reported Event|Placebo|Patients were randomized to receive placebo for 8 weeks
10861315|NCT00367484|BG000|Baseline|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
10861316|NCT00367484|FG000|Participant Flow|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
10861317|NCT00367484|OG000|Outcome|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
10861318|NCT00367484|EG000|Reported Event|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
10861319|NCT00367601|BG000|Baseline|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
10861320|NCT00367601|FG000|Participant Flow|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
10861321|NCT00367601|OG000|Outcome|Single Arm|Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
10861322|NCT00367601|OG000|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
10861323|NCT00367601|EG000|Reported Event|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
10861324|NCT00367640|BG000|Baseline|100 IR|100 IR grass pollen allergen extract tablet
10861325|NCT00367640|BG001|Baseline|300 IR|300 IR grass pollen allergen extract tablet
10861326|NCT00367640|BG002|Baseline|500 IR|500 IR grass pollen allergen extract tablet
10861327|NCT00367640|BG003|Baseline|Placebo|Placebo tablet
10861328|NCT00367640|BG004|Baseline|Total|Total of all reporting groups
10861329|NCT00367640|FG000|Participant Flow|100 IR|100 IR grass pollen allergen extract tablet
10861330|NCT00367640|FG001|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
10861331|NCT00367640|FG002|Participant Flow|500 IR|500 IR grass pollen allergen extract tablet
10861332|NCT00367640|FG003|Participant Flow|Placebo|Placebo tablet
10861333|NCT00367640|OG000|Outcome|100 IR|100 IR grass pollen allergen extract tablet
10861334|NCT00367640|OG001|Outcome|300 IR|300 IR grass pollen allergen extract tablet
10861335|NCT00367640|OG002|Outcome|500 IR|500 IR grass pollen allergen extract tablet
10861336|NCT00367640|OG003|Outcome|Placebo|Placebo tablet
10861337|NCT00367640|EG000|Reported Event|500 IR|500 IR grass pollen allergen extract tablet
10861338|NCT00367640|EG001|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
10861339|NCT00367640|EG002|Reported Event|100 IR|100 IR grass pollen allergen extract tablet
10861340|NCT00367640|EG003|Reported Event|Placebo|Placebo tablet
10861341|NCT00367679|BG000|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
10861342|NCT00367679|FG000|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
10861343|NCT00367679|OG000|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
10861344|NCT00367679|OG000|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
10861345|NCT00367679|OG000|Outcome|Overall Study Arm|
10861346|NCT00367679|EG000|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
10861347|NCT00367744|BG000|Baseline|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then the dose increased to 4mg twice daily for the remainder of the study (44 weeks)
10861348|NCT00367744|BG001|Baseline|Placebo|Placebo arm
10861349|NCT00367744|BG002|Baseline|Total|Total of all reporting groups
10861350|NCT00367744|FG000|Participant Flow|Rosiglitazone|Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks)
10861351|NCT00367744|FG001|Participant Flow|Placebo|Placebo arm for the whole duration of the study
10861352|NCT00367744|OG000|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then BID for 44 weeks
10861353|NCT00367744|OG001|Outcome|Placebo|Placebo arm
10861354|NCT00367744|OG000|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
10861355|NCT00367744|EG000|Reported Event|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
10861356|NCT00367744|EG001|Reported Event|Placebo|Placebo arm
10861357|NCT00367770|BG000|Baseline|Overall Study Arm|
10861358|NCT00367770|FG000|Participant Flow|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
10861359|NCT00367770|OG000|Outcome|Overall Study Arm|
10861360|NCT00367770|EG000|Reported Event|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
10861361|NCT00367835|BG000|Baseline|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
10861362|NCT00367835|BG001|Baseline|Placebo|
10861363|NCT00367835|BG002|Baseline|Total|Total of all reporting groups
10861364|NCT00367835|FG000|Participant Flow|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
10861365|NCT00367835|FG001|Participant Flow|Placebo|
10861366|NCT00367835|OG000|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
10861367|NCT00367835|OG001|Outcome|Placebo|
10861368|NCT00367835|EG000|Reported Event|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
10861369|NCT00367835|EG001|Reported Event|Placebo|
10861370|NCT00367991|BG000|Baseline|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
10861371|NCT00367991|BG001|Baseline|Placebo|Normal saline volume to match active treatment IV daily for 3 days
10861372|NCT00367991|BG002|Baseline|Total|Total of all reporting groups
10861373|NCT00367991|FG000|Participant Flow|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
10861374|NCT00367991|FG001|Participant Flow|Placebo|Normal saline volume to match active treatment IV daily for 3 days
10861375|NCT00367991|OG000|Outcome|Placebo|normal saline
10861376|NCT00367991|OG001|Outcome|rHuEPO|recombinant human erythropoietin
10861377|NCT00367991|EG000|Reported Event|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
10861378|NCT00367991|EG001|Reported Event|Placebo|Normal saline volume to match active treatment IV daily for 3 days
10861379|NCT00368069|BG000|Baseline|Keppra®|Keppra® extended release formulation (XR)
10861380|NCT00368069|BG001|Baseline|Placebo|placebo
10861381|NCT00368069|BG002|Baseline|Total|Total of all reporting groups
10861382|NCT00368069|FG000|Participant Flow|Keppra®|Keppra® extended release formulation (XR)
10861383|NCT00368069|FG001|Participant Flow|Placebo|placebo
10861384|NCT00368069|OG000|Outcome|Keppra®|Keppra® extended release formulation (XR)
10861385|NCT00368069|OG001|Outcome|Placebo|placebo
10861386|NCT00368069|EG000|Reported Event|Keppra®|Keppra® extended release formulation (XR)
10861387|NCT00368069|EG001|Reported Event|Placebo|placebo
10861388|NCT00368108|BG000|Baseline|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
10861389|NCT00368108|BG001|Baseline|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
10861390|NCT00368108|BG002|Baseline|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
10861391|NCT00368108|BG003|Baseline|Total|Total of all reporting groups
10861392|NCT00368108|FG000|Participant Flow|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
11348660|NCT04149925|FG001|Participant Flow|Echelon Flex Powered Stapler|"Stapling performed by Echelon Flex Powered Stapler~Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler"
10861393|NCT00368108|FG001|Participant Flow|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
10861394|NCT00368108|FG002|Participant Flow|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
10861395|NCT00368108|OG000|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
10861396|NCT00368108|OG001|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
10861397|NCT00368108|OG002|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
10861398|NCT00368108|EG000|Reported Event|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
10861399|NCT00368108|EG001|Reported Event|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
10861400|NCT00368108|EG002|Reported Event|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
10861401|NCT00368251|BG000|Baseline|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
10861402|NCT00368251|BG001|Baseline|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
10861403|NCT00368251|BG002|Baseline|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
10861404|NCT00368251|BG003|Baseline|Total Title|
10861405|NCT00368251|FG000|Participant Flow|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
10861406|NCT00368251|FG001|Participant Flow|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
10861407|NCT00368251|FG002|Participant Flow|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
10861408|NCT00368251|OG000|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
10861409|NCT00368251|OG001|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
10861410|NCT00368251|OG002|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
10861411|NCT00368251|EG000|Reported Event|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
10861412|NCT00368251|EG001|Reported Event|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
10861413|NCT00368251|EG002|Reported Event|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
10861414|NCT00368277|BG000|Baseline|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
10861415|NCT00368277|BG001|Baseline|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
10861416|NCT00368277|BG002|Baseline|Total|Total of all reporting groups
10861417|NCT00368277|FG000|Participant Flow|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
10861418|NCT00368277|FG001|Participant Flow|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
10861419|NCT00368277|OG000|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
10861420|NCT00368277|OG001|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
10861421|NCT00368277|EG000|Reported Event|Aliskiren|Aliskiren based regimen
10861422|NCT00368277|EG001|Reported Event|Ramipril|Ramipril based regimen
10861423|NCT00368290|BG000|Baseline|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
10861424|NCT00368290|BG001|Baseline|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
10861425|NCT00368290|BG002|Baseline|Total|Total of all reporting groups
10861426|NCT00368290|FG000|Participant Flow|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
10861427|NCT00368290|FG001|Participant Flow|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
10861428|NCT00368290|OG000|Outcome|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
10861429|NCT00368290|OG001|Outcome|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
10861430|NCT00368290|EG000|Reported Event|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
10861431|NCT00368290|EG001|Reported Event|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
10861432|NCT00368316|BG000|Baseline|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
10861433|NCT00368316|BG001|Baseline|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
10861434|NCT00368316|BG002|Baseline|Total|Total of all reporting groups
10861435|NCT00368316|FG000|Participant Flow|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
10861436|NCT00368316|FG001|Participant Flow|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
10861437|NCT00368316|OG000|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
10861438|NCT00368316|OG001|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
10861439|NCT00368316|EG000|Reported Event|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
10861440|NCT00368316|EG001|Reported Event|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
10861441|NCT00368355|BG000|Baseline|CLINIMACS Device|"Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device~Ara-C: day-8 through day-5~3 g/m2 q 12 hours~Cyclophosphamide: day-7 and day-6~45 mg/kg~Campath-1H: day-3 through day-1~Dosing for children:~5 - 15kg : 3mg IV in 30ml NS~15.1 - 30kg : 5mg IV in 50ml NS~>30 kg : 10mg IV in 100ml NS~Adults will receive 10mg IV in 100ml NS~Total Body Irradiation: day-4 through day-1~175 cGy x 2 at 24 cGy/min~Stem Cell Infusion: Stem cells are infused on day 0"
10861442|NCT00368355|BG001|Baseline|ISOLEX Device|"Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device~Ara-C: day-8 through day-5~3 g/m2 q 12 hours~Cyclophosphamide: day-7 and day-6~45 mg/kg~Campath-1H: day-3 through day-1~Dosing for children:~5 - 15kg : 3mg IV in 30ml NS~15.1 - 30kg : 5mg IV in 50ml NS~>30 kg : 10mg IV in 100ml NS~Adults will receive 10mg IV in 100ml NS~Total Body Irradiation: day-4 through day-1~175 cGy x 2 at 24 cGy/min~Stem Cell Infusion: Stem cells are infused on day 0"
10861443|NCT00368355|BG002|Baseline|Total|Total of all reporting groups
10861444|NCT00368355|FG000|Participant Flow|CLINIMACS Device|"Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device~Ara-C: day-8 through day-5~3 g/m2 q 12 hours~Cyclophosphamide: day-7 and day-6~45 mg/kg~Campath-1H: day-3 through day-1~Dosing for children:~5 - 15kg : 3mg IV in 30ml NS~15.1 - 30kg : 5mg IV in 50ml NS~>30 kg : 10mg IV in 100ml NS~Adults will receive 10mg IV in 100ml NS~Total Body Irradiation: day-4 through day-1~175 cGy x 2 at 24 cGy/min~Stem Cell Infusion: Stem cells are infused on day 0"
10861445|NCT00368355|FG001|Participant Flow|ISOLEX Device|"Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device~Ara-C: day-8 through day-5~3 g/m2 q 12 hours~Cyclophosphamide: day-7 and day-6~45 mg/kg~Campath-1H: day-3 through day-1~Dosing for children:~5 - 15kg : 3mg IV in 30ml NS~15.1 - 30kg : 5mg IV in 50ml NS~>30 kg : 10mg IV in 100ml NS~Adults will receive 10mg IV in 100ml NS~Total Body Irradiation: day-4 through day-1~175 cGy x 2 at 24 cGy/min~Stem Cell Infusion: Stem cells are infused on day 0"
10861446|NCT00368355|OG000|Outcome|CLINIMACS Device|"Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device~Ara-C: day-8 through day-5~3 g/m2 q 12 hours~Cyclophosphamide: day-7 and day-6~45 mg/kg~Campath-1H: day-3 through day-1~Dosing for children:~5 - 15kg : 3mg IV in 30ml NS~15.1 - 30kg : 5mg IV in 50ml NS~>30 kg : 10mg IV in 100ml NS~Adults will receive 10mg IV in 100ml NS~Total Body Irradiation: day-4 through day-1~175 cGy x 2 at 24 cGy/min~Stem Cell Infusion: Stem cells are infused on day 0"
10861447|NCT00368355|OG001|Outcome|ISOLEX Device|"Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device~Ara-C: day-8 through day-5~3 g/m2 q 12 hours~Cyclophosphamide: day-7 and day-6~45 mg/kg~Campath-1H: day-3 through day-1~Dosing for children:~5 - 15kg : 3mg IV in 30ml NS~15.1 - 30kg : 5mg IV in 50ml NS~>30 kg : 10mg IV in 100ml NS~Adults will receive 10mg IV in 100ml NS~Total Body Irradiation: day-4 through day-1~175 cGy x 2 at 24 cGy/min~Stem Cell Infusion: Stem cells are infused on day 0"
10861448|NCT00368355|EG000|Reported Event|CLINIMACS Device|"Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device~Ara-C: day-8 through day-5~3 g/m2 q 12 hours~Cyclophosphamide: day-7 and day-6~45 mg/kg~Campath-1H: day-3 through day-1~Dosing for children:~5 - 15kg : 3mg IV in 30ml NS~15.1 - 30kg : 5mg IV in 50ml NS~>30 kg : 10mg IV in 100ml NS~Adults will receive 10mg IV in 100ml NS~Total Body Irradiation: day-4 through day-1~175 cGy x 2 at 24 cGy/min~Stem Cell Infusion: Stem cells are infused on day 0"
10861449|NCT00368355|EG001|Reported Event|ISOLEX Device|"Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device~Ara-C: day-8 through day-5~3 g/m2 q 12 hours~Cyclophosphamide: day-7 and day-6~45 mg/kg~Campath-1H: day-3 through day-1~Dosing for children:~5 - 15kg : 3mg IV in 30ml NS~15.1 - 30kg : 5mg IV in 50ml NS~>30 kg : 10mg IV in 100ml NS~Adults will receive 10mg IV in 100ml NS~Total Body Irradiation: day-4 through day-1~175 cGy x 2 at 24 cGy/min~Stem Cell Infusion: Stem cells are infused on day 0"
10861450|NCT00368459|BG000|Baseline|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
10861451|NCT00368459|BG001|Baseline|Placebo|identical appearing oral placebo
10861452|NCT00368459|BG002|Baseline|Total|Total of all reporting groups
10861453|NCT00368459|FG000|Participant Flow|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
10861454|NCT00368459|FG001|Participant Flow|Placebo|identical appearing oral placebo
10861455|NCT00368459|OG000|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
10861456|NCT00368459|OG001|Outcome|Placebo|identical appearing oral placebo
10861457|NCT00368459|EG000|Reported Event|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
10861458|NCT00368459|EG001|Reported Event|Placebo|identical appearing oral placebo
10861459|NCT00368472|BG000|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
10861460|NCT00368472|FG000|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
10861461|NCT00368472|OG000|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
10861462|NCT00368472|EG000|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
10861463|NCT00368537|BG000|Baseline|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
10861464|NCT00368537|BG001|Baseline|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
10861465|NCT00368537|BG002|Baseline|Total|Total of all reporting groups
10861466|NCT00368537|FG000|Participant Flow|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
10977041|NCT00943306|OG000|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
10861467|NCT00368537|FG001|Participant Flow|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
10861468|NCT00368537|OG000|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
10861469|NCT00368537|OG001|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
10861470|NCT00368537|EG000|Reported Event|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
10861471|NCT00368537|EG001|Reported Event|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
10861472|NCT00368550|BG000|Baseline|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
10861473|NCT00368550|BG001|Baseline|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
10861474|NCT00368550|BG002|Baseline|Total|Total of all reporting groups
10861475|NCT00368550|FG000|Participant Flow|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
10861476|NCT00368550|FG001|Participant Flow|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
10861477|NCT00368550|OG000|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
10861478|NCT00368550|OG001|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
10861479|NCT00368550|EG000|Reported Event|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
10861480|NCT00368550|EG001|Reported Event|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
10861481|NCT00368641|BG000|Baseline|Intervention Group|Addition of peritoneal ultrafiltration
10861482|NCT00368641|BG001|Baseline|Standard Therapy|Standard therapy for CHF
10861483|NCT00368641|BG002|Baseline|Total|Total of all reporting groups
10861484|NCT00368641|FG000|Participant Flow|Intervention Group|Addition of peritoneal ultrafiltration
10861485|NCT00368641|FG001|Participant Flow|Standard Therapy|Standard therapy for CHF
10861486|NCT00368641|OG000|Outcome|Intervention Group|Addition of peritoneal ultrafiltration
10861487|NCT00368641|OG001|Outcome|Standard Therapy|Standard therapy for CHF
10861488|NCT00368641|EG000|Reported Event|Intervention Group|Addition of peritoneal ultrafiltration
10861489|NCT00368641|EG001|Reported Event|Standard Therapy|Standard therapy for CHF
10861490|NCT00368745|BG000|Baseline|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
10861491|NCT00368745|BG001|Baseline|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
10861492|NCT00368745|BG002|Baseline|Total|Total of all reporting groups
10861493|NCT00368745|FG000|Participant Flow|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
10861494|NCT00368745|FG001|Participant Flow|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
10977042|NCT00943306|EG000|Reported Event|Lomitapide|"Maximum tolerated dose of lomitapide (up to 80mg/day) in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
11348661|NCT04149925|OG000|Outcome|AEON Endostapler|"Stapling performed by AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
10861495|NCT00368745|OG000|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
10861496|NCT00368745|OG001|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
10861497|NCT00368745|EG000|Reported Event|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
10861498|NCT00368745|EG001|Reported Event|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
10861499|NCT00368849|BG000|Baseline|All Participants|Age, sex, and region of enrollment were available for all 20 participants.
10861500|NCT00368849|FG000|Participant Flow|Atomoxetine (4 Weeks) Then Placebo (4 Weeks)|Participants received 40 milligram twice a day atomoxetine for four weeks. After a two week wash out, they then received twice a day matching placebo for four weeks.
10861501|NCT00368849|FG001|Participant Flow|Placebo (4 Weeks) Then Atomoxetine (4 Weeks)|Participants received twice a day matching placebo for four weeks. After a two week washout, they then received 40 milligram twice a day atomoxetine for four weeks.
10861502|NCT00368849|OG000|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine
10861503|NCT00368849|OG001|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
10861504|NCT00368849|OG000|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
10861505|NCT00368849|EG000|Reported Event|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
10861506|NCT00368849|EG001|Reported Event|Matching Placebo|Individuals in this arm received twice a day matching placebo.
10861507|NCT00368875|BG000|Baseline|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
10861508|NCT00368875|FG000|Participant Flow|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
10861509|NCT00368875|FG001|Participant Flow|Phase II|"Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
10861510|NCT00368875|OG000|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
10861511|NCT00368875|OG000|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
10861512|NCT00368875|OG000|Outcome|Vorinostat, Paclitaxel, Bevacizumab|"Vorinostat BID on days 1-3, 8-10, and 15-17, paclitaxel IV over 1 hour on days 2, 9, and 16, bevacizumab IV over 30-90 minutes on days 2 and 16, repeat every 28 days.~vorinostat: Given orally~paclitaxel: Given IV~bevacizumab: Given IV"
10861513|NCT00368875|EG000|Reported Event|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1-3, 8-10, and 15-17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
10861514|NCT00368927|BG000|Baseline|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
10861515|NCT00368927|BG001|Baseline|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
10861516|NCT00368927|BG002|Baseline|Total|Total of all reporting groups
10861517|NCT00368927|FG000|Participant Flow|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
10861518|NCT00368927|FG001|Participant Flow|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
10861519|NCT00368927|OG000|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
10861520|NCT00368927|OG001|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
10861521|NCT00368927|EG000|Reported Event|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
10861522|NCT00368927|EG001|Reported Event|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
11348662|NCT04149925|OG001|Outcome|Echelon Flex Powered Stapler|"Stapling performed by Echelon Flex Powered Stapler~Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler"
11348663|NCT04149925|EG000|Reported Event|AEON Endostapler|"Stapling performed by AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
10861523|NCT00368940|BG000|Baseline|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
10861524|NCT00368940|BG001|Baseline|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
10861525|NCT00368940|BG002|Baseline|Total|Total of all reporting groups
10861526|NCT00368940|FG000|Participant Flow|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
10861527|NCT00368940|FG001|Participant Flow|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
10861528|NCT00368940|OG000|Outcome|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
10861529|NCT00368940|OG001|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
10861530|NCT00368940|OG000|Outcome|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
11348664|NCT04149925|EG001|Reported Event|Echelon Flex Powered Stapler|"Stapling performed by Echelon Flex Powered Stapler~Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler"
10861531|NCT00368940|EG000|Reported Event|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
10861532|NCT00368940|EG001|Reported Event|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
10861533|NCT00368966|BG000|Baseline|13vPnC|Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec.
10861534|NCT00368966|BG001|Baseline|7vPnC|Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec.
10861535|NCT00368966|BG002|Baseline|Total|Total of all reporting groups
10861536|NCT00368966|FG000|Participant Flow|13vPnC|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
10861537|NCT00368966|FG001|Participant Flow|7vPnC|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
10861538|NCT00368966|OG000|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
10861539|NCT00368966|OG001|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
10861540|NCT00368966|OG000|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months(toddler dose).
10861541|NCT00368966|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
10861542|NCT00368966|OG001|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
10861543|NCT00368966|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
10861544|NCT00368966|OG003|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
10861545|NCT00368966|OG004|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
10861546|NCT00368966|OG005|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
10861547|NCT00368966|OG006|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
10861548|NCT00368966|OG007|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
11348665|NCT04150224|BG000|Baseline|Cohort 1 (C1A), PBTZ169|"Two doses of PBTZ169: 640 mg OD fasted and 640 mg OD after meal. Wash-out period ≥6 days.~PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect"
10861549|NCT00368966|OG000|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months (infant series).
10861550|NCT00368966|OG001|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
10861551|NCT00368966|OG002|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
10861552|NCT00368966|OG000|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
10861553|NCT00368966|OG001|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
10861554|NCT00368966|OG003|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months.
10861555|NCT00368966|OG000|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
10861556|NCT00368966|OG001|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
10861557|NCT00368966|OG003|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
10861558|NCT00368966|OG000|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
10861559|NCT00368966|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
10861560|NCT00368966|EG001|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
10861561|NCT00368966|EG002|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.
10861562|NCT00368966|EG003|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.
10861563|NCT00368966|EG004|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
10861564|NCT00368966|EG005|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
10861565|NCT00368966|EG006|Reported Event|13vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.
10861566|NCT00368966|EG007|Reported Event|7vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.
10861567|NCT00368979|BG000|Baseline|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
10861568|NCT00368979|BG001|Baseline|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
10861569|NCT00368979|BG002|Baseline|Total|Total of all reporting groups
10861570|NCT00368979|FG000|Participant Flow|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
10861571|NCT00368979|FG001|Participant Flow|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
10861572|NCT00368979|OG000|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
10861573|NCT00368979|OG001|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
10861574|NCT00368979|EG000|Reported Event|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
10861575|NCT00368979|EG001|Reported Event|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
10861576|NCT00368992|BG000|Baseline|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
10861577|NCT00368992|FG000|Participant Flow|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|"This was a single arm Phase II trial. Patients were treated with induction therapy cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Patients who were not removed due to unacceptable toxicity or disease progression were then treated with maintenance therapy cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
10861578|NCT00368992|OG000|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
10861579|NCT00368992|OG000|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
10861580|NCT00368992|EG000|Reported Event|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
11348666|NCT04150224|BG001|Baseline|Cohort 1 (C1B), PBTZ169|"Two doses of PBTZ169: 640 mg OD after meal and 640 OD mg fasted. Wash-out period ≥6 days.~PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect"
10861581|NCT00369122|BG000|Baseline|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
10861582|NCT00369122|FG000|Participant Flow|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
10861583|NCT00369122|OG000|Outcome|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
10861584|NCT00369122|EG000|Reported Event|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.~Data is reported for all patients who received study treatment, which is 59 patients."
10861585|NCT00369161|BG000|Baseline|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
10861586|NCT00369161|BG001|Baseline|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
10861587|NCT00369161|BG002|Baseline|Total|Total of all reporting groups
10861588|NCT00369161|FG000|Participant Flow|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
10861589|NCT00369161|FG001|Participant Flow|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
10879016|NCT00454987|EG002|Reported Event|Meningitec+Hiberix Group|"Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.~This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme."
11348667|NCT04150224|BG002|Baseline|Cohort 2 (C2), PBTZ169|"Single dose of PBTZ169: 960 mg fasted~PBTZ169 960 mg SD: Once a day fasted"
10861590|NCT00369161|OG000|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
10861591|NCT00369161|OG001|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
10861592|NCT00369161|EG000|Reported Event|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
10861593|NCT00369161|EG001|Reported Event|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
10861594|NCT00369226|BG000|Baseline|Phase I|
10861595|NCT00369226|BG001|Baseline|Phase II|
10861596|NCT00369226|BG002|Baseline|Total|Total of all reporting groups
10861597|NCT00369226|FG000|Participant Flow|Phase I (45 Days)|Bortezomib plus tacrolimus and methotrexate after mismatched allogeneic non-myeloablative hematopoietic stem cell transplantation (HSCT).
10861598|NCT00369226|FG001|Participant Flow|Phase II (45 Days)|
10861599|NCT00369226|OG000|Outcome|Phase I|
10861600|NCT00369226|OG000|Outcome|Combined Phase I Plus Phase II|This reports on the total phase I plus phase II patients who were evaluable for chimerism endpoint (37 of the 45 patients).
10861601|NCT00369226|OG000|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
10861602|NCT00369226|OG000|Outcome|Phase I and Phase II|Engraftment is determined for all treated patients across both phase I and phase II (n=45) who are evaluable for this endpoint (n=35)
10861603|NCT00369226|OG000|Outcome|Progression-free Survival (PFS)|This reports on all treated patients across both phase I and phase II (n=45)
10861604|NCT00369226|OG001|Outcome|Overall Survival (OS)|This reports on all treated patients across both phase I and phase II (n=45)
10861605|NCT00369226|EG000|Reported Event|Phase I-II|
10861606|NCT00369278|BG000|Baseline|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
10861607|NCT00369278|BG001|Baseline|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
10861608|NCT00369278|BG002|Baseline|Total|Total of all reporting groups
10861609|NCT00369278|FG000|Participant Flow|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
10861610|NCT00369278|FG001|Participant Flow|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
10861611|NCT00369278|OG000|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
10861612|NCT00369278|OG001|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
10861613|NCT00369278|EG000|Reported Event|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
10861614|NCT00369278|EG001|Reported Event|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study (month 6): 1440 mg/day (2 x 720 mg)
10861615|NCT00369343|BG000|Baseline|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
10861616|NCT00369343|BG001|Baseline|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
10861617|NCT00369343|BG002|Baseline|Total|Total of all reporting groups
10861618|NCT00369343|FG000|Participant Flow|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
10861619|NCT00369343|FG001|Participant Flow|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
10861620|NCT00369343|OG000|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
10861621|NCT00369343|OG001|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
10861622|NCT00369343|OG000|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
10861623|NCT00369343|OG001|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
10861624|NCT00369343|OG000|Outcome|0 mg|Placebo
10861625|NCT00369343|OG001|Outcome|100 mg|DVS SR 100mg dosage was reduced to DVS SR 50mg for 7 days.
10861626|NCT00369343|OG002|Outcome|200 mg|DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
10861627|NCT00369343|EG000|Reported Event|Double-blind DVS SR|"Days 1 to 7:~Patients will be instructed to take 1-50mg tablet per day~Days 8 to 14:~Patients will be instructed to take 1-100mg tablet per day~Days 15 to 56:~At the discretion of the investigator, patients may be assigned to 100mg or 200mg tablets per day"
10861628|NCT00369343|EG001|Reported Event|Double-blind Placebo|Placebo administered daily for 8 weeks
10861629|NCT00369343|EG002|Reported Event|Open-label DVS SR/ DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
10861630|NCT00369343|EG003|Reported Event|Open-label Placebo/DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
10861631|NCT00369382|BG000|Baseline|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
10861632|NCT00369382|BG001|Baseline|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
10861633|NCT00369382|BG002|Baseline|Total|Total of all reporting groups
10861634|NCT00369382|FG000|Participant Flow|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
10861635|NCT00369382|FG001|Participant Flow|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
11348668|NCT04150224|BG003|Baseline|Cohort 3 (C3), PBTZ169|"Two doses of PBTZ169: 640 mg twice a day (fasted) with a 12-hour interval; total daily dose - 1280 mg~PBTZ169 640 mg BiD: Twice a day fasted; 1 day of administration"
11348669|NCT04150224|BG004|Baseline|Cohort 4 (C4), PBTZ169|"Single dose of PBTZ169: 1280 mg fasted~PBTZ169 1280 mg SD: Once a day fasted"
11348670|NCT04150224|BG005|Baseline|Cohort 5 (C5), PBTZ169|"Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days~PBTZ169 1280 mg MD: Once a day after meal, 14 doses"
11348671|NCT04150224|BG006|Baseline|Total|Total of all reporting groups
11348672|NCT04150224|FG000|Participant Flow|Cohort 1 (C1A), PBTZ169|"Two doses of PBTZ169: 640 mg OD fasted and 640 mg OD after meal. Wash-out period ≥6 days.~PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect"
11348673|NCT04150224|FG001|Participant Flow|Cohort 1 (C1B), PBTZ169|"Two doses of PBTZ169: 640 mg OD after meal and 640 OD mg fasted. Wash-out period ≥6 days.~PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect"
11348674|NCT04150224|FG002|Participant Flow|Cohort 2 (C2), PBTZ169|"Single dose of PBTZ169: 960 mg fasted~PBTZ169 960 mg SD: Once a day fasted"
11348675|NCT04150224|FG003|Participant Flow|Cohort 3 (C3), PBTZ169|"Two doses of PBTZ169: 640 mg twice a day (fasted) with a 12-hour interval; total daily dose - 1280 mg~PBTZ169 640 mg BiD: Twice a day fasted; 1 day of administration"
11348676|NCT04150224|FG004|Participant Flow|Cohort 4 (C4), PBTZ169|"Single dose of PBTZ169: 1280 mg fasted~PBTZ169 1280 mg SD: Once a day fasted"
11348677|NCT04150224|FG005|Participant Flow|Cohort 5 (C5), PBTZ169|"Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days~PBTZ169 1280 mg MD: Once a day after meal, 14 doses"
11348678|NCT04150224|OG000|Outcome|Cohort 1 (C1A+C1B), PBTZ169|"Two doses of PBTZ169: 640 mg OD fasted/after meal and 640 mg OD after meal/fasted. Wash-out period ≥6 days.~PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect"
11348679|NCT04150224|OG001|Outcome|Cohort 2 (C2), PBTZ169|"Single dose of PBTZ169: 960 mg fasted~PBTZ169 960 mg SD: Once a day fasted"
11348680|NCT04150224|OG002|Outcome|Cohort 3 (C3), PBTZ169|"Two doses of PBTZ169: 640 mg twice a day (fasted) with a 12-hour interval; total daily dose - 1280 mg~PBTZ169 640 mg BiD: Twice a day fasted; 1 day of administration"
11348681|NCT04150224|OG003|Outcome|Cohort 4 (C4), PBTZ169|"Single dose of PBTZ169: 1280 mg fasted~PBTZ169 1280 mg SD: Once a day fasted"
11348682|NCT04150224|OG004|Outcome|Cohort 5 (C5), PBTZ169|"Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days~PBTZ169 1280 mg MD: Once a day after meal, 14 doses"
11348683|NCT04150224|OG000|Outcome|Cohort 1 (C1A), PBTZ169|"Two doses of PBTZ169: 640 mg OD fasted and 640 mg OD after meal. Wash-out period ≥6 days.~PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect"
11348684|NCT04150224|OG001|Outcome|Cohort 1 (C1B), PBTZ169|"Two doses of PBTZ169: 640 mg OD after meal and 640 OD mg fasted. Wash-out period ≥6 days.~PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect"
11348685|NCT04150224|OG002|Outcome|Cohort 2 (C2), PBTZ169|"Single dose of PBTZ169: 960 mg fasted~PBTZ169 960 mg SD: Once a day fasted"
11348686|NCT04150224|OG003|Outcome|Cohort 3 (C3), PBTZ169|"Two doses of PBTZ169: 640 mg twice a day (fasted) with a 12-hour interval; total daily dose - 1280 mg~PBTZ169 640 mg BiD: Twice a day fasted; 1 day of administration"
11348687|NCT04150224|OG004|Outcome|Cohort 4 (C4), PBTZ169|"Single dose of PBTZ169: 1280 mg fasted~PBTZ169 1280 mg SD: Once a day fasted"
11348688|NCT04150224|OG005|Outcome|Cohort 5 (C5), PBTZ169|"Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days~PBTZ169 1280 mg MD: Once a day after meal, 14 doses"
11348689|NCT04150224|OG000|Outcome|Cohort 1 (C1A+C1B), PBTZ169, Fasted|PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect
11348690|NCT04150224|OG001|Outcome|Cohort 1 (C1A+C1B), PBTZ169, After Meal|PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect
11348691|NCT04150224|OG005|Outcome|Cohort 5 (C5), PBTZ169|"Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days~PBTZ169 1280 mg MD: Once a day after meals, 14 doses"
11348692|NCT04150224|OG000|Outcome|Cohort 5 (C5), PBTZ169|"Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days~PBTZ169 1280 mg MD: Once a day after meals, 14 doses"
11348693|NCT04150224|OG000|Outcome|"Cohort 1 (C1A+C1B), PBTZ169, After Meals (T)/Fasted (R)"|PBTZ169 640 mg OD: Two administrations once a day with a wash-out period (cross-over): food effect
11348694|NCT04150224|EG000|Reported Event|Cohort 1 (C1A+C1B), PBTZ169|"Two doses of PBTZ169: 640 mg OD fasted/after meal and 640 mg OD after meal/fasted. Wash-out period ≥6 days.~PBTZ169 640 mg OD: Two administrations once a day with a wash-out period: food effect"
11348695|NCT04150224|EG001|Reported Event|Cohort 2 (C2), PBTZ169|"Single dose of PBTZ169: 960 mg fasted~PBTZ169 960 mg SD: Once a day fasted"
11348696|NCT04150224|EG002|Reported Event|Cohort 3 (C3), PBTZ169|"Two doses of PBTZ169: 640 mg twice a day (fasted) with a 12-hour interval; total daily dose - 1280 mg~PBTZ169 640 mg BiD: Twice a day fasted; 1 day of administration"
11348697|NCT04150224|EG003|Reported Event|Cohort 4 (C4), PBTZ169|"Single dose of PBTZ169: 1280 mg fasted~PBTZ169 1280 mg SD: Once a day fasted"
11348698|NCT04150224|EG004|Reported Event|Cohort 5 (C5), PBTZ169|"Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days~PBTZ169 1280 mg MD: Once a day after meal, 14 doses"
11348699|NCT04149405|BG000|Baseline|Group A|subjects with chronic periodontitis and osteoporosis
11348700|NCT04149405|BG001|Baseline|Group B|subjects with chronic periodontitis and systemically healthy
11348701|NCT04149405|BG002|Baseline|Group C|subjects with periodontally healthy and osteoporosis
11348702|NCT04149405|BG003|Baseline|Group D|systemically and periodontally healthy controls
11348703|NCT04149405|BG004|Baseline|Total|Total of all reporting groups
11348704|NCT04149405|FG000|Participant Flow|Group A|subjects with chronic periodontitis and osteoporosis
11348705|NCT04149405|FG001|Participant Flow|Group B|subjects with chronic periodontitis and systemically healthy
11348706|NCT04149405|FG002|Participant Flow|Group C|subjects with periodontally healthy and osteoporosis
11348707|NCT04149405|FG003|Participant Flow|Group D|systemically and periodontally healthy controls
11348708|NCT04149405|OG000|Outcome|Group A|"scaling and root planning, bisphosphonate therapy (zoledronic acid)~periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.~bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)~GCF: gingival crevicular fluid collection by the same investigator."
10861636|NCT00369382|OG000|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
10861637|NCT00369382|OG001|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
10861638|NCT00369382|OG000|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
10861639|NCT00369382|EG000|Reported Event|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
10861640|NCT00369382|EG001|Reported Event|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
10861641|NCT00369486|BG000|Baseline|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
10861642|NCT00369486|BG001|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
10861643|NCT00369486|BG002|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
10861644|NCT00369486|BG003|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
10861645|NCT00369486|BG004|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
10861646|NCT00369486|BG005|Baseline|Total|Total of all reporting groups
10861647|NCT00369486|FG000|Participant Flow|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
10861648|NCT00369486|FG001|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
10861649|NCT00369486|FG002|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
10861650|NCT00369486|FG003|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
10861651|NCT00369486|FG004|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
10861652|NCT00369486|OG000|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
10861653|NCT00369486|OG001|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
10861654|NCT00369486|OG002|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
10861655|NCT00369486|OG003|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
10861656|NCT00369486|OG004|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
10861657|NCT00369486|EG000|Reported Event|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
10861658|NCT00369486|EG001|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
10861659|NCT00369486|EG002|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
10861660|NCT00369486|EG003|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
10861661|NCT00369486|EG004|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
10861662|NCT00369512|BG000|Baseline|Erlotinib|Erlotinib therapy for 2 weeks (150 mg once per day)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg once per day).
10861663|NCT00369512|FG000|Participant Flow|Erlotinib|Erlotinib therapy for 2 weeks (150 mg by mouth (PO) every day(QD))(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
10861664|NCT00369512|OG000|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
10861665|NCT00369512|EG000|Reported Event|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
10861666|NCT00369564|BG000|Baseline|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
10861667|NCT00369564|BG001|Baseline|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
10861668|NCT00369564|BG002|Baseline|Total|Total of all reporting groups
10861669|NCT00369564|FG000|Participant Flow|Arm I Glutamic Acid|Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a total of 1500 mg/day of oral glutamic acid .
10861670|NCT00369564|FG001|Participant Flow|Arm II Placebo|"Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent.~Patients with a body surface area (BSA) less than 1.0 m^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). ."
10861671|NCT00369564|OG000|Outcome|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
10861672|NCT00369564|OG001|Outcome|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
10861673|NCT00369564|OG000|Outcome|Arm I Glutamic Acid|"Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).~glutamic acid: Given orally 3 times daily"
10861674|NCT00369564|OG001|Outcome|Arm II Placebo|"Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).~placebo: Given orally 3 times daily"
10861675|NCT00369564|OG000|Outcome|Arm I Glutamic Acid|Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a total of 1500 mg/day of oral glutamic acid .
10861676|NCT00369564|OG001|Outcome|Arm II Placebo|"Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent.~Patients with a body surface area (BSA) less than 1.0 m^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). ."
10861677|NCT00369564|EG000|Reported Event|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
10861678|NCT00369564|EG001|Reported Event|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
10861679|NCT00369577|BG000|Baseline|Inhaled Placebo|Inhaled Staccato Placebo, single dose
10861680|NCT00369577|BG001|Baseline|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
10861681|NCT00369577|BG002|Baseline|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
10861682|NCT00369577|BG003|Baseline|Total|Total of all reporting groups
10861683|NCT00369577|FG000|Participant Flow|Inhaled Placebo|Inhaled Staccato Placebo, single dose
10861684|NCT00369577|FG001|Participant Flow|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
10861685|NCT00369577|FG002|Participant Flow|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
10861686|NCT00369577|OG000|Outcome|Inhaled Placebo|Inhaled Staccato Placebo, single dose
10861687|NCT00369577|OG001|Outcome|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
10861688|NCT00369577|OG002|Outcome|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
10861689|NCT00369577|EG000|Reported Event|Inhaled Placebo|Inhaled Staccato Placebo, single dose
10861690|NCT00369577|EG001|Reported Event|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
10861691|NCT00369577|EG002|Reported Event|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
10861692|NCT00369590|BG000|Baseline|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
10861693|NCT00369590|BG001|Baseline|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
10861694|NCT00369590|BG002|Baseline|Total|Total of all reporting groups
10861695|NCT00369590|FG000|Participant Flow|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
10861696|NCT00369590|FG001|Participant Flow|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
10861697|NCT00369590|OG000|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
10861698|NCT00369590|OG001|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
10861699|NCT00369590|EG000|Reported Event|All Study Patients|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
10861700|NCT00369629|BG000|Baseline|Gemcitabine and Pemetrexed Disodium|"Gemcitabine: Patients will be treated in cohorts of 3-6 per cohort. The starting dose of gemcitabine will be 800 mg/m^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 1200 mg/m^2.~Pemetrexed: Patients will be treated in cohorts of 3-6 per cohort. The starting dose of pemetrexed will be 400 mg/m^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 500 mg/m^2."
10861701|NCT00369629|FG000|Participant Flow|Cohort 1|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 400 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 800 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861702|NCT00369629|FG001|Participant Flow|Cohort 2|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 800 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861703|NCT00369629|FG002|Participant Flow|Cohort 3|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 1000 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861704|NCT00369629|FG003|Participant Flow|Cohort 4|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 1200 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861705|NCT00369629|OG000|Outcome|Cohort 1|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 400 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 800 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861706|NCT00369629|OG001|Outcome|Cohort 2|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 800 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861707|NCT00369629|OG002|Outcome|Cohort 3|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 1000 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861708|NCT00369629|OG003|Outcome|Cohort 4|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 1200 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861709|NCT00369629|EG000|Reported Event|Cohort 1|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 400 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 800 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861710|NCT00369629|EG001|Reported Event|Cohort 2|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 800 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861711|NCT00369629|EG002|Reported Event|Cohort 3|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 1000 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861712|NCT00369629|EG003|Reported Event|Cohort 4|"Patients will be treated in cohorts of 3-6 per cohort in a dose escalation of pemetrexed and gemcitabine~Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle.~Gemcitabine at a dose of 1200 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle."
10861713|NCT00369655|BG000|Baseline|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10861714|NCT00369655|FG000|Participant Flow|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10861715|NCT00369655|OG000|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10861716|NCT00369655|EG000|Reported Event|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10861717|NCT00369668|BG000|Baseline|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
10861718|NCT00369668|BG001|Baseline|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
10861719|NCT00369668|BG002|Baseline|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
10861720|NCT00369668|BG003|Baseline|Total|Total of all reporting groups
10861721|NCT00369668|FG000|Participant Flow|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
10861722|NCT00369668|FG001|Participant Flow|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
10861723|NCT00369668|FG002|Participant Flow|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
10861724|NCT00369668|OG000|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
10861725|NCT00369668|OG001|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
10861726|NCT00369668|OG002|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
10861727|NCT00369668|OG000|Outcome|High Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Four times per week for two weeks.
10861728|NCT00369668|OG001|Outcome|Low Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Two times per week for two weeks.
10861729|NCT00369668|OG002|Outcome|Control|Bilateral movements coupled with sham neuromuscular electrical stimulation. Two times per week for two weeks.
10861730|NCT00369668|EG000|Reported Event|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
10861731|NCT00369668|EG001|Reported Event|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
10861732|NCT00369668|EG002|Reported Event|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
10861733|NCT00369681|BG000|Baseline|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
10861734|NCT00369681|FG000|Participant Flow|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
10861735|NCT00369681|OG000|Outcome|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
10861736|NCT00369681|EG000|Reported Event|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
10861737|NCT00369707|BG000|Baseline|Bortezomib and Rituximab|"Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.~Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.~Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only."
10861738|NCT00369707|FG000|Participant Flow|Bortezomib and Rituximab|"Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.~Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.~Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only."
10861739|NCT00369707|OG000|Outcome|Bortezomib and Rituximab|"Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.~Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.~Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only."
10861740|NCT00369707|EG000|Reported Event|Bortezomib and Rituximab|"Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.~Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.~Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only."
10861741|NCT00369746|BG000|Baseline|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
10861742|NCT00369746|BG001|Baseline|Major Depression Only|Major Depression without alcohol abuse disorder
10861743|NCT00369746|BG002|Baseline|Total|Total of all reporting groups
10861744|NCT00369746|FG000|Participant Flow|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence and Major Depression
10861745|NCT00369746|FG001|Participant Flow|Major Depression Only|Major Depression without alcohol abuse disorder
10861746|NCT00369746|OG000|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
10861747|NCT00369746|OG001|Outcome|Major Depression Only|citalopram (Non alcoholic)
10861748|NCT00369746|EG000|Reported Event|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
10861749|NCT00369746|EG001|Reported Event|Major Depression Only|Major Depression without alcohol abuse disorder
11348709|NCT04149405|OG001|Outcome|Group B|"scaling and root planning, no bisphosphonate therapy~periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.~GCF: gingival crevicular fluid collection by the same investigator."
11348710|NCT04149405|OG002|Outcome|Group C|"bisphosphonate therapy (zoledronic acid)~bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)~GCF: gingival crevicular fluid collection by the same investigator."
11348711|NCT04149405|OG003|Outcome|Group D|Systemically and periodontally healthy controls No intervention has been made
11348712|NCT04149405|OG000|Outcome|Group A|"Subjects with chronic periodontitis and osteoporosis.~Phase 1 periodontal therapy and bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.~Phase 1 periodontal therapy: Scaling and root planning with ultrasonic and hand instruments under local anesthesia.~Bisphosphonate therapy: Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year"
11348713|NCT04149405|OG001|Outcome|Group B|"Subjects with chronic periodontitis and systemically healthy.~Phase 1 periodontal theraphy was administered to the subjects.~Phase 1 periodontal therapy: Scaling and root planning with ultrasonic and hand instruments under local anesthesia."
11348714|NCT04149405|OG002|Outcome|Group C|"Subjects with periodontally healthy and osteoporosis.~Bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.~Bisphosphonate therapy: Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year"
11348715|NCT04149405|OG000|Outcome|Group A|-Subjects with chronic periodontitis and osteoporosis.
11348716|NCT04149405|OG001|Outcome|Group B|-Subjects with chronic periodontitis and systemically healthy.
11348717|NCT04149405|OG002|Outcome|Group C|-Subjects with periodontally healthy and osteoporosis.
11348718|NCT04149405|EG000|Reported Event|Group A|Participants received periodontal phase 1 treatment and used bisphosphonate.
11348719|NCT04149405|EG001|Reported Event|Group B|Participants received periodontal phase 1 treatment.
11348720|NCT04149405|EG002|Reported Event|Group C|Participants used bisphosphonate.
11348721|NCT04149405|EG003|Reported Event|Group D|Participants did not receive any treatment.
11348722|NCT04144088|BG000|Baseline|Wu Ling San|"Drug : Wu Ling San Extract Granules Sun-Ten~Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks."
11348723|NCT04144088|BG001|Baseline|Yin-Chen Wu Ling San|"Drug : Yin-Chen-Wu-Ling-San Extract Power SUN-TEN~Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks."
11348724|NCT04144088|BG002|Baseline|Placebo|"Drug : 1/10 Wu Ling San~Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks."
11348725|NCT04144088|BG003|Baseline|Total|Total of all reporting groups
11348726|NCT04144088|FG000|Participant Flow|Wu Ling San|"Drug : Wu Ling San Extract Granules Sun-Ten~Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks."
11348727|NCT04144088|FG001|Participant Flow|Yin-Chen Wu Ling San|"Drug : Yin-Chen-Wu-Ling-San Extract Power SUN-TEN~Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks."
11348728|NCT04144088|FG002|Participant Flow|Placebo|"Drug : 1/10 Wu Ling San~Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks."
11348729|NCT04144088|OG000|Outcome|Wu Ling San|"Drug : Wu Ling San Extract Granules Sun-Ten~Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks."
11348730|NCT04144088|OG001|Outcome|Yin-Chen Wu Ling San|"Drug : Yin-Chen-Wu-Ling-San Extract Power SUN-TEN~Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks."
11348731|NCT04144088|OG002|Outcome|Placebo|"Drug : 1/10 Wu Ling San~Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks."
11348732|NCT04144088|EG000|Reported Event|Wu Ling San|"Drug : Wu Ling San Extract Granules Sun-Ten~Wu Ling San: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks."
11348733|NCT04144088|EG001|Reported Event|Yin-Chen Wu Ling San|"Drug : Yin-Chen-Wu-Ling-San Extract Power SUN-TEN~Yin-Chen Wu Ling San: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks."
11348734|NCT04144088|EG002|Reported Event|Placebo|"Drug : 1/10 Wu Ling San~Placebo: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks."
11348735|NCT04149353|BG000|Baseline|Breast Cancer Patients|Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment.
11348736|NCT04149353|FG000|Participant Flow|Breast Cancer Patients|Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment.
11348737|NCT04149353|OG000|Outcome|Breast Cancer Patients|Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment.
11348738|NCT04149353|OG000|Outcome|Breast Cancer Patients|"Each patient will undergo two combined PET/MR scans. The pre-treatment and post-treatment combined PET/MR scans are for research purposes and not part of the patient's standard of care.~PET/MR: Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant chemotherapy per the direction of the medical oncologist. Within four weeks after completion of chemotherapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery if they are still surgical candidates."
11348739|NCT04149353|EG000|Reported Event|Breast Cancer Patients|Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment.
10861750|NCT00369785|BG000|Baseline|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
10861751|NCT00369785|BG001|Baseline|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
10861752|NCT00369785|BG002|Baseline|Total|Total of all reporting groups
10861753|NCT00369785|FG000|Participant Flow|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
10861754|NCT00369785|FG001|Participant Flow|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
10861755|NCT00369785|OG000|Outcome|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
10861756|NCT00369785|OG001|Outcome|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
10861757|NCT00369785|EG000|Reported Event|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
10861758|NCT00369785|EG001|Reported Event|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
10861759|NCT00369824|BG000|Baseline|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
10861760|NCT00369824|BG001|Baseline|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
10861761|NCT00369824|BG002|Baseline|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
10861762|NCT00369824|BG003|Baseline|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
10861763|NCT00369824|BG004|Baseline|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
10861764|NCT00369824|BG005|Baseline|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
10861765|NCT00369824|BG006|Baseline|Total|Total of all reporting groups
10861766|NCT00369824|FG000|Participant Flow|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
10861767|NCT00369824|FG001|Participant Flow|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
10861768|NCT00369824|FG002|Participant Flow|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
10861769|NCT00369824|FG003|Participant Flow|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
10861770|NCT00369824|FG004|Participant Flow|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
10861771|NCT00369824|FG005|Participant Flow|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
10861772|NCT00369824|OG000|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
10861773|NCT00369824|OG001|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
10861774|NCT00369824|OG002|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
10861775|NCT00369824|OG003|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
10861776|NCT00369824|OG004|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
10861777|NCT00369824|OG005|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
10861778|NCT00369824|EG000|Reported Event|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
10861779|NCT00369824|EG001|Reported Event|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
10861780|NCT00369824|EG002|Reported Event|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
10861781|NCT00369824|EG003|Reported Event|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
10861782|NCT00369824|EG004|Reported Event|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
10861783|NCT00369824|EG005|Reported Event|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
10861784|NCT00369915|BG000|Baseline|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
10861785|NCT00369915|BG001|Baseline|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
10861786|NCT00369915|BG002|Baseline|Total|Total of all reporting groups
10861787|NCT00369915|FG000|Participant Flow|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
10861788|NCT00369915|FG001|Participant Flow|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
10861789|NCT00369915|OG000|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
10861790|NCT00369915|OG001|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
10861791|NCT00369915|EG000|Reported Event|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
10861792|NCT00369915|EG001|Reported Event|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
10861793|NCT00369928|BG000|Baseline|Placebo|Placebo, oral dose, BID
10861794|NCT00369928|BG001|Baseline|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
10861795|NCT00369928|BG002|Baseline|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
10861796|NCT00369928|BG003|Baseline|Total|Total of all reporting groups
10861797|NCT00369928|FG000|Participant Flow|Placebo|Placebo, oral dose, BID
10861798|NCT00369928|FG001|Participant Flow|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
10861799|NCT00369928|FG002|Participant Flow|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
10861800|NCT00369928|OG000|Outcome|Placebo|Placebo, oral dose, BID
10861801|NCT00369928|OG001|Outcome|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
10861802|NCT00369928|OG002|Outcome|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
10861803|NCT00369928|EG000|Reported Event|Placebo|Placebo, oral dose, BID
10861804|NCT00369928|EG001|Reported Event|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
10861805|NCT00369928|EG002|Reported Event|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
10861806|NCT00369941|BG000|Baseline|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861807|NCT00369941|BG001|Baseline|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861808|NCT00369941|BG002|Baseline|Total|Total of all reporting groups
10861809|NCT00369941|FG000|Participant Flow|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861810|NCT00369941|FG001|Participant Flow|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861811|NCT00369941|OG000|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861812|NCT00369941|OG001|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861813|NCT00369941|OG000|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861814|NCT00369941|EG000|Reported Event|MK-0518 400 mg b.i.d.|MK-0518 400 mg taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, taken PO (q.h.s.) on an empty stomach preferably at bedtime (q.h.s.). All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily with food with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861815|NCT00369941|EG001|Reported Event|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg taken by mouth on an empty stomach preferably at bedtime (q.h.s.), and placebo to MK-0518 taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
10861816|NCT00369967|BG000|Baseline|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
10861817|NCT00369967|BG001|Baseline|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
10861818|NCT00369967|BG002|Baseline|Total|Total of all reporting groups
10861819|NCT00369967|FG000|Participant Flow|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
10861820|NCT00369967|FG001|Participant Flow|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
10861821|NCT00369967|OG000|Outcome|Quick Start|"Start method day of enrollment~NuvaRing: Initiation of NuvaRing for contraception"
10861822|NCT00369967|OG001|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception
10861823|NCT00369967|OG000|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
10861824|NCT00369967|OG001|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
10861825|NCT00369967|OG000|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
10861826|NCT00369967|OG001|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
10861827|NCT00369967|EG000|Reported Event|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
10861828|NCT00369967|EG001|Reported Event|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
10861829|NCT00370032|BG000|Baseline|d-IBS|Diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
10861830|NCT00370032|BG001|Baseline|Healthy Volunteers|Volunteers without clinical disease. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
10861831|NCT00370032|BG002|Baseline|Total|Total of all reporting groups
10861832|NCT00370032|FG000|Participant Flow|d-IBS (Diarrhea Predominant - Irritable Bowel Syndrome)|Subjects with diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by a flexible sigmoidoscopy then had a 7 day follow up period.
10861833|NCT00370032|FG001|Participant Flow|Healthy Volunteers|Subjects with no clinical disease. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by flexible sigmoidoscopy then had a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
10861834|NCT00370032|OG000|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
10861835|NCT00370032|OG001|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1, this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
10861836|NCT00370032|OG002|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
10861837|NCT00370032|OG003|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
10861838|NCT00370032|OG001|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
10861839|NCT00370032|OG000|Outcome|d-IBS Placebo - Left Colon|Subjects with diarrhea-predominant irritable bowel syndrome . Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
10861840|NCT00370032|OG001|Outcome|d-IBS Placebo - Rectal|Subjects with diarrhea-predominant irritable bowel syndrome. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
10861841|NCT00370032|OG002|Outcome|Healthy Volunteers Placebo - Left Colon|Subjects without Clinical disease. Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
10861842|NCT00370032|OG003|Outcome|Healthy Volunteers Placebo - Rectal|Subjects without clinical disease. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
10861843|NCT00370032|EG000|Reported Event|d-IBS Placebo|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
10861844|NCT00370032|EG001|Reported Event|d-IBS Alosetron|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
10861845|NCT00370032|EG002|Reported Event|Healthy Volunteers Placebo|Volunteers without clinical disease. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
10861846|NCT00370032|EG003|Reported Event|Healthy Volunteers Alosetron|Volunteers without clinical disease. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
10861847|NCT00370071|BG000|Baseline|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 micrograms (8 MIU [million international units]) subcutaneously every other day.
10861848|NCT00370071|FG000|Participant Flow|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
10861849|NCT00370071|OG000|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
10977043|NCT00943319|BG000|Baseline|Busulfan and Fludarabine|"Intravenous busulfan (Busulfan®) in combination with fludarabine~Busulfan: Daily intravenous dosing to target AVC~Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.~Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).~Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated)."
10861850|NCT00370071|EG000|Reported Event|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
10861851|NCT00370149|BG000|Baseline|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were sized to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM) and C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC).
10861852|NCT00370149|BG001|Baseline|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J RSC).
10861853|NCT00370149|BG002|Baseline|Total|Total of all reporting groups
10861854|NCT00370149|FG000|Participant Flow|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to M/R had the catheter impregnated with minocycline and rifampin (M/R) inserted intraoperatively. The specific Central Venous Catheters are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
10861855|NCT00370149|FG001|Participant Flow|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to this arm had the conventional Central Venous Catheter (C/S) with no antibiotic coating inserted intraoperatively. The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
10861856|NCT00370149|OG000|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr. 8 cm long, (C-UDLM-501J-ABRM-HC), or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
10861857|NCT00370149|OG001|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
10861858|NCT00370149|OG000|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
10861859|NCT00370149|OG001|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
10861860|NCT00370149|OG001|Outcome|Conventional Non-impegnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J) 5 Fr.,12 cm long, (C-UDLM-501J-RSC).
10861861|NCT00370149|EG000|Reported Event|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if a therapeutic difference existed between M/R and C/S catheters. Patients randomized to this Arm had the M/R catheter inserted intra-operatively. Patients receiving this Catheter were enrolled in the study. The specific CVCs are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). Patients were followed for adverse device affects and adverse events through their hospitalization stay.
10861862|NCT00370149|EG001|Reported Event|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if there was a therapeutic difference between the M/R and C/S catheters. Patients randomized to this arm had the C/S inserted intra-operatively. Patients receiving this catheter were enrolled in the study.The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC). Patients were followed for adverse device affects and adverse events through their hospitalization stay
10861863|NCT00370292|BG000|Baseline|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
10861864|NCT00370292|BG001|Baseline|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
10861865|NCT00370292|BG002|Baseline|Total|Total of all reporting groups
10861866|NCT00370292|FG000|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
10861867|NCT00370292|OG000|Outcome|dCK - Cycle 1|Mean dCK expression evaluated at Cycle 1.
10861868|NCT00370292|OG001|Outcome|dCK - Cycle 2|Mean dCK expression evaluated at Cycle 2.
10861869|NCT00370292|OG002|Outcome|dCK - Cycle 3|Mean dCK expression evaluated at Cycle 3.
10861870|NCT00370292|OG000|Outcome|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
10861871|NCT00370292|OG001|Outcome|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
10861872|NCT00370292|OG000|Outcome|hENT - Cycle 1|Mean hENT expression evaluated at Cycle 1.
10861873|NCT00370292|OG001|Outcome|hENT - Cycle 2|Mean hENT expression evaluated at Cycle 2.
10861874|NCT00370292|OG002|Outcome|hENT - Cycle 3|Mean hENT expression evaluated at Cycle 3.
10861875|NCT00370292|EG000|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
10879017|NCT00455013|BG000|Baseline|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
10879018|NCT00455013|BG001|Baseline|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
10879019|NCT00455013|BG002|Baseline|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
10879020|NCT00455013|BG003|Baseline|Total|Total of all reporting groups
10879021|NCT00455013|FG000|Participant Flow|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; intravenous infusion (IV) belatacept: 10 milligram per kilogram of weight (mg/kg) Day 1 (day of transplant) and Day 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF (mycophenolate mofetil) 1g twice daily(BID). Participants were allowed to switch from MMF to sirolimus. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1 (day of transplant), 2, 3, 4, up to maximum dose of 6 mg/kg.
10879022|NCT00455013|FG001|Participant Flow|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 nanograms per milliliter (ng/mL) for first 6 months, followed by 5 - 10 ng/mL until 12 months. Participants were allowed to switch from sirolimus to MMF. Background immunosuppressive medications: methylprednisolone was administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4, up to maximum dose of 6 mg/kg.
10879023|NCT00455013|FG002|Participant Flow|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF 1g BID. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1, 2, 3, 4 up to maximum dose of 6 mg/kg.
10879024|NCT00455013|OG000|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
10879025|NCT00455013|OG001|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
10879026|NCT00455013|OG002|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
10879027|NCT00455013|EG000|Reported Event|Belatacept - MMF|
10879028|NCT00455013|EG001|Reported Event|Belatacept - SIRO|
10879029|NCT00455013|EG002|Reported Event|Tacrolimus - MMF|
10879030|NCT00455195|BG000|Baseline|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
10879031|NCT00455195|BG001|Baseline|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
10879032|NCT00455195|BG002|Baseline|Total|Total of all reporting groups
10879033|NCT00455195|FG000|Participant Flow|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
10861876|NCT04876274|BG000|Baseline|Intervention Group|"Patients in the intervention group received the TMU line-oriented video education and care in addition to usual care~TMU-LOVE: Patients in intervention group could attend diabetes-related health educational video through the TMU-LOVE platform. Researcher would also send 2-3 videos per week with care massage every 2 weeks to the patients."
10861877|NCT04876274|BG001|Baseline|Control Group|Patients in the control group received usual care
10861878|NCT04876274|BG002|Baseline|Total|Total of all reporting groups
10861879|NCT04876274|FG000|Participant Flow|Intervention Group|"Patients in the intervention group received the TMU line-oriented video education and care in addition to usual care~TMU-LOVE: Patients in intervention group could attend diabetes-related health educational video through the TMU-LOVE platform. Researcher would also send 2-3 videos per week with care massage every 2 weeks to the patients."
10861880|NCT04876274|FG001|Participant Flow|Control Group|Patients in the control group received usual care
10861881|NCT04876274|OG000|Outcome|Intervention Group|"Patients in the intervention group received the TMU line-oriented video education and care in addition to usual care~TMU-LOVE: Patients in intervention group could attend diabetes-related health educational video through the TMU-LOVE platform. Researcher would also send 2-3 videos per week with care massage every 2 weeks to the patients."
10861882|NCT04876274|OG001|Outcome|Control Group|Patients in the control group received usual care
10861883|NCT04876274|EG000|Reported Event|Intervention|Patients in the intervention group received the TMU line-oriented video education and care in addition to usual care
10861884|NCT04876274|EG001|Reported Event|Control|Patients in the control group received usual care
10861907|NCT04150341|BG000|Baseline|All Study Participants|Participants were randomized to 1 of 6 treatment sequences. Each treatment period was 14 days with a 21 day washout between treatments. All participants were randomized to receive all study drugs.
10861908|NCT04150341|FG000|Participant Flow|TD-8236 150 mcg/TD-8236 1500 mcg/Placebo|"Participants received TD-8236 150 mcg first, then TD-8236 1500 mcg, and then Placebo.~All treatment periods were 14 days with a 21 day washout period between treatments."
10861909|NCT04150341|FG001|Participant Flow|TD-8236 150 mcg/Placebo/TD-8236 1500 mcg|"Participants received TD-8236 150 mcg first, then Placebo, and then TD-8236 1500 mcg.~All treatment periods were 14 days with a 21 day washout period between treatments."
10861910|NCT04150341|FG002|Participant Flow|Placebo/TD-8236 1500 mcg/TD-8236 150 mcg|"Participants received Placebo first, then TD-8236 1500 mcg, and then TD-8236 150 mcg.~All treatment periods were 14 days with a 21 day washout period between treatments."
10861911|NCT04150341|FG003|Participant Flow|Placebo/TD-8236 150 mcg/TD-8236 1500 mcg|"Participants received Placebo first, then TD-8236 150 mcg, and then TD-8236 1500 mcg.~All treatment periods were 14 days with a 21 day washout period between treatments."
10861912|NCT04150341|FG004|Participant Flow|TD-8236 1500 mcg/Placebo/TD-8236 150 mcg|"Participants received TD-8236 1500 mcg first, then Placebo, and then TD-8236 150 mcg.~All treatment periods were 14 days with a 21 day washout period between treatments."
10861913|NCT04150341|FG005|Participant Flow|TD-8236 1500 mcg/TD-8236 150 mcg/Placebo|"Participants received TD-8236 1500 mcg first, then TD-8236 150 mcg, and then Placebo.~All treatment periods were 14 days with a 21 day washout period between treatments."
10861914|NCT04150341|OG000|Outcome|Placebo|Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
10861915|NCT04150341|OG001|Outcome|TD-8236 150 mcg|Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
10861916|NCT04150341|OG002|Outcome|TD-8236 1500 mcg|Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
10861917|NCT04150341|OG000|Outcome|TD-8236 150 mcg|Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
10861918|NCT04150341|OG001|Outcome|TD-8236 1500 mcg|Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
10861919|NCT04150341|EG000|Reported Event|Placebo|Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
10861920|NCT04150341|EG001|Reported Event|TD-8236 150 mcg|Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
10861921|NCT04150341|EG002|Reported Event|TD-8236 1500 mcg|Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
10861922|NCT04115839|BG000|Baseline|Filgotinib 200 mg (Main Study)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861923|NCT04115839|BG001|Baseline|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for 16 weeks.
10861924|NCT04115839|BG002|Baseline|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861925|NCT04115839|BG003|Baseline|Total|Total of all reporting groups
10861885|NCT04656691|BG000|Baseline|Participants With COVID-19|"Participants testing positive for COVID-19 may be eligible to receive a one-time dose of bamlanivimab 700 mg, delivered via infusion through the vein, lasting around 60 minutes. This infusion will be done in-home and administered by a registered nurse.~bamlanivimab: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab by a registered nurse. This infusion will last approximately 1 hour followed by 1 hour of observation."
10861886|NCT04656691|FG000|Participant Flow|Treatment: Participants With COVID-19|Participants testing positive for COVID-19 may be eligible to receive a one-time dose of bamlanivimab 700 mg, delivered via infusion through the vein, lasting around 60 minutes. This infusion will be done in-home and administered by a registered nurse followed by 1 hour of observation..
10861887|NCT04656691|OG000|Outcome|Treatment|Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab
10861888|NCT04656691|EG000|Reported Event|Treatment|Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab
10861889|NCT04615299|BG000|Baseline|Auricular Acupuncture|"Auricular (Battlefield) acupuncture needles will be utilized in the test arm, location of needles and stickers will be placed according to 5 VA approved BFA auricular acupuncture points associated with PONV, pain, and anxiety respectively~Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine."
10861890|NCT04615299|BG001|Baseline|Sham Acupuncture|"The control arm will receive sham or placebo acupuncture via pressing of a blunt needle on the specified BFA locations and then application of adhesive stickers. In the control group simulating acupuncture, the needles will never enter the patients' skin and will give the impression to the patient that the procedure has taken place.~Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine."
10861891|NCT04615299|BG002|Baseline|Total|Total of all reporting groups
10861892|NCT04615299|FG000|Participant Flow|Auricular Acupuncture|"Auricular (Battlefield) acupuncture needles will be utilized in the test arm, location of needles and stickers will be placed according to 5 VA approved BFA auricular acupuncture points associated with PONV, pain, and anxiety respectively~Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine."
10861893|NCT04615299|FG001|Participant Flow|Sham Acupuncture|"The control arm will receive sham or placebo acupuncture via pressing of a blunt needle on the specified BFA locations and then application of adhesive stickers. In the control group simulating acupuncture, the needles will never enter the patients' skin and will give the impression to the patient that the procedure has taken place.~Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine."
10861894|NCT04615299|OG000|Outcome|Auricular Acupuncture|"Auricular (Battlefield) acupuncture needles will be utilized in the test arm, location of needles and stickers will be placed according to 5 VA approved BFA auricular acupuncture points associated with PONV, pain, and anxiety respectively~Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine."
10861895|NCT04615299|OG001|Outcome|Sham Acupuncture|"The control arm will receive sham or placebo acupuncture via pressing of a blunt needle on the specified BFA locations and then application of adhesive stickers. In the control group simulating acupuncture, the needles will never enter the patients' skin and will give the impression to the patient that the procedure has taken place.~Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine."
10861896|NCT04615299|EG000|Reported Event|Auricular Acupuncture|"Auricular (Battlefield) acupuncture needles will be utilized in the test arm, location of needles and stickers will be placed according to 5 VA approved BFA auricular acupuncture points associated with PONV, pain, and anxiety respectively~Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine."
10861897|NCT04615299|EG001|Reported Event|Sham Acupuncture|"The control arm will receive sham or placebo acupuncture via pressing of a blunt needle on the specified BFA locations and then application of adhesive stickers. In the control group simulating acupuncture, the needles will never enter the patients' skin and will give the impression to the patient that the procedure has taken place.~Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine."
10861898|NCT04555096|BG000|Baseline|Active GC4419|"Arm A~GC4419: 180 Minute IV Infusion"
10861899|NCT04555096|BG001|Baseline|Placebo|"Arm B~Placebo: 180 Minute IV Infusion"
10861900|NCT04555096|BG002|Baseline|Total|Total of all reporting groups
10861901|NCT04555096|FG000|Participant Flow|Active GC4419|"Arm A~GC4419: 180 Minute IV Infusion"
10861902|NCT04555096|FG001|Participant Flow|Placebo|"Arm B~Placebo: 180 Minute IV Infusion"
10861903|NCT04555096|OG000|Outcome|Active GC4419|"Arm A~GC4419: 180 Minute IV Infusion"
10861904|NCT04555096|OG001|Outcome|Placebo|"Arm B~Placebo: 180 Minute IV Infusion"
10861905|NCT04555096|EG000|Reported Event|Active GC4419|"Arm A~GC4419: 180 Minute IV Infusion"
10861906|NCT04555096|EG001|Reported Event|Placebo|"Arm B~Placebo: 180 Minute IV Infusion"
10861926|NCT04115839|FG000|Participant Flow|Filgotinib 200 mg (Main Study)|Filgotinib 200 milligrams (mg) tablet orally once daily + placebo to match (PTM) filgotinib 100 mg tablet orally once daily for 16 weeks.
10861927|NCT04115839|FG001|Participant Flow|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for 16 weeks.
10861928|NCT04115839|FG002|Participant Flow|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861929|NCT04115839|FG003|Participant Flow|Filgotinib 200 mg From Filgotinib 200 mg (LTE)|"Long term extension (LTE):~Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 44.3 weeks. Participants received filgotinib 200 mg in the Main Study."
10861930|NCT04115839|FG004|Participant Flow|Filgotinib 100 mg From Filgotinib 100 mg (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 43.9 weeks. Participants received filgotinib 100 mg in the Main Study.
10861931|NCT04115839|FG005|Participant Flow|Filgotinib 200 mg From Placebo (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 44.1 weeks. Participants received placebo in the Main Study.
10861932|NCT04115839|FG006|Participant Flow|Filgotinib 100 mg From Placebo (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 44 weeks. Participants received placebo in the Main Study.
10861933|NCT04115839|OG000|Outcome|Filgotinib 200 mg (Main Study)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861934|NCT04115839|OG001|Outcome|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for 16 weeks.
10861935|NCT04115839|OG002|Outcome|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861936|NCT04115839|OG000|Outcome|Filgotinib 200 mg From Filgotinib 200 mg (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 44.3 weeks. Participants received filgotinib 200 mg in the Main Study.
10861937|NCT04115839|OG001|Outcome|Filgotinib 100 mg From Filgotinib 100 mg (LTE)|Filgotinib 100 mg tablet orally once daily+ PTM filgotinib 200 mg tablet orally once daily for up to 43.9 weeks. Participants received filgotinib 100 mg in the Main Study.
10861938|NCT04115839|OG002|Outcome|Filgotinib 200 mg From Placebo (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 44.1 weeks. Participants received placebo in the Main Study.
10861939|NCT04115839|OG003|Outcome|Filgotinib 100 mg From Placebo (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 44 weeks. Participants received placebo in the Main Study.
10861940|NCT04115839|OG001|Outcome|Filgotinib 100 mg From Filgotinib 100 mg (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 43.9 weeks. Participants received filgotinib 100 mg in the Main Study.
10861941|NCT04115839|OG000|Outcome|Filgotinib 200 mg (Main Study)|Filgotinib 200 mg tablet orally once daily+ PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861942|NCT04115839|OG002|Outcome|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily+ PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861943|NCT04115839|OG001|Outcome|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily+ PTM filgotinib 200 mg tablet orally once daily for 16 weeks.
10861944|NCT04115839|OG000|Outcome|Filgotinib 200 mg From Filgotinib 200 mg (LTE)|Filgotinib 200 mg tablet orally once daily+ PTM filgotinib 100 mg tablet orally once daily for up to 44.3 weeks. Participants received filgotinib 200 mg in the Main Study.
10861945|NCT04115839|OG002|Outcome|Filgotinib 200 mg From Placebo (LTE)|Filgotinib 200 mg tablet orally once daily+ PTM filgotinib 100 mg tablet orally once daily for up to 44.1 weeks. Participants received placebo in the Main Study.
10861946|NCT04115839|OG003|Outcome|Filgotinib 100 mg From Placebo (LTE)|Filgotinib 100 mg tablet orally once daily+ PTM filgotinib 200 mg tablet orally once daily for up to 44 weeks. Participants received placebo in the Main Study.
10861947|NCT04115839|OG002|Outcome|Filgotinib 200 mg From Placebo (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet for orally once daily up to 44.1 weeks. Participants received placebo in the Main Study.
10861948|NCT04115839|OG003|Outcome|Filgotinib 100 mg From Placebo (LTE)|Filgotinib 100 mg tablet orally once daily+ PTM filgotinib 200 mg tablet orally once daily or up to 44 weeks. Participants received placebo in the Main Study.
10861949|NCT04115839|EG000|Reported Event|Filgotinib 200 mg (Main Study)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861950|NCT04115839|EG001|Reported Event|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for 16 weeks.
10861951|NCT04115839|EG002|Reported Event|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks.
10861952|NCT04115839|EG003|Reported Event|Filgotinib 200 mg From Filgotinib 200 mg (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 44.3 weeks. Participants received filgotinib 200 mg in the Main Study.
10861953|NCT04115839|EG004|Reported Event|Filgotinib 100 mg From Filgotinib 100 mg (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 43.9 weeks. Participants received filgotinib 100 mg in the Main Study.
10861954|NCT04115839|EG005|Reported Event|Filgotinib 200 mg From Placebo (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 44.1 weeks. Participants received placebo in the Main Study.
10861955|NCT04115839|EG006|Reported Event|Filgotinib 100 mg From Placebo (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 44 weeks. Participants received placebo in the Main Study.
10861956|NCT04078126|BG000|Baseline|Overall Study|Intent-to-Treat (ITT) Population
10861957|NCT04078126|FG000|Participant Flow|BFF MDI/Symbicort Turbuhaler|Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation followed by washout period and then Symbicort Turbuhaler
10861958|NCT04078126|FG001|Participant Flow|Symbicort Turbuhaler/BFF MDI|Subject treated with Symbicort Turbuhaler followed by washout period and then Budesonide Formoterol Fumarate Metered Dose Inhalation
10861959|NCT04078126|OG000|Outcome|BFF MDI|Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation
10861960|NCT04078126|OG001|Outcome|Symbicort Turbuhaler|Subject treated with Symbicort Turbuhaler
10861961|NCT04078126|EG000|Reported Event|BFF MDI|Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation
10861962|NCT04078126|EG001|Reported Event|Symbicort Turbuhaler|Subject treated with Symbicort Turbuhaler
10861963|NCT03825341|BG000|Baseline|Arm 1 Liquid Hydroxyurea|"In Arm 1 of this study, n=18 infants ages 9 months to 2 years will be administered an extemporaneous oral liquid formulation of HU on a single occasion followed by PK sampling. The dose administered will be ~20 mg/kg/day or the infant's usual daily dose.~Hydroxyurea: Drug: Hydroxyurea oral liquid dose administered will be 20mg/kg/day or infants's usual daily dose."
11348130|NCT04214080|OG001|Outcome|Control Group (CG).|"(NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills."
11348131|NCT04214080|OG001|Outcome|Control Group (CG).|"(NDT-B) concept approaches and feeding and oral motor intervention strategies were applied to this group in routine treatment.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment (NDT): NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills."
11348132|NCT04214080|OG000|Outcome|Study Group (SG)|"In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.~Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). All of these"
11348133|NCT04214080|EG000|Reported Event|Study Group (SG)|"In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.~Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure)."
11348134|NCT04214080|EG001|Reported Event|Control Group (CG).|"(NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment.~Treatments were continued 2 days a week for 6 weeks (12 sessions).~Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.~Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills."
11348740|NCT04137783|BG000|Baseline|Homozygous or Compound Heterozygous ABCA3 Mutations|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which indicated homozgyous or compound heterozygous ABCA3 mutations.~no intervention: there is no intervention in this study, only observation."
11348741|NCT04137783|BG001|Baseline|Single ABCA3 Mutation|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which indicated single mutations.~no intervention: there is no intervention in this study, only observation."
11348742|NCT04137783|BG002|Baseline|no ABCA3 Mutations|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which exclude all gene mutations involving in the respiratory disease.~no intervention: there is no intervention in this study, only observation."
11348743|NCT04137783|BG003|Baseline|Total|Total of all reporting groups
11348744|NCT04137783|FG000|Participant Flow|Homozygous or Compound Heterozygous ABCA3 Mutations|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which indicated homozgyous or compound heterozygous ABCA3 mutations.~no intervention: there is no intervention in this study, only observation."
11348745|NCT04137783|FG001|Participant Flow|Single ABCA3 Mutation|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which indicated single mutations.~no intervention: there is no intervention in this study, only observation."
11348746|NCT04137783|FG002|Participant Flow|no ABCA3 Mutations|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which exclude all gene mutations involving in the respiratory disease.~no intervention: there is no intervention in this study, only observation."
11348747|NCT04137783|OG000|Outcome|Homozygous or Compound Heterozygous ABCA3 Mutations|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which indicated homozgyous or compound heterozygous ABCA3 mutations.~no intervention: there is no intervention in this study, only observation."
11348748|NCT04137783|OG001|Outcome|Single ABCA3 Mutation|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which indicated single mutations.~no intervention: there is no intervention in this study, only observation."
11348749|NCT04137783|OG002|Outcome|no ABCA3 Mutations|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which exclude all gene mutations involving in the respiratory disease.~no intervention: there is no intervention in this study, only observation."
11348750|NCT04137783|EG000|Reported Event|Homozygous or Compound Heterozygous ABCA3 Mutations|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which indicated homozgyous or compound heterozygous ABCA3 mutations.~no intervention: there is no intervention in this study, only observation."
10861964|NCT03825341|BG001|Baseline|Arm 2 Hydroxyurea Oral Capsule|"In Arm 2, n=30 children who range in age from 2 to 18 years will be administered oral capsule HU, both a sprinkle formulation and capsules (Droxia® 200 mg), on two separate occasions separated by at least 1 but no more than 30 days in a randomized, crossover fashion. The doses of HU on each occasion will be rounded to the nearest 200 mg and will not exceed 35 mg/kg or 2000 mg~Hydroxyurea Oral Capsule: Drug: Hydroxyurea both a sprinkle formulation and capsules (Droxia 200mg) administered on 2 separate occasions."
10861965|NCT03825341|BG002|Baseline|Total|Total of all reporting groups
10861966|NCT03825341|FG000|Participant Flow|Arm 1 Liquid Hydroxyurea|"In Arm 1 of this study, n=18 infants ages 9 months to 2 years will be administered an extemporaneous oral liquid formulation of HU on a single occasion followed by PK sampling. The dose administered will be ~20 mg/kg/day or the infant's usual daily dose.~Hydroxyurea: Drug: Hydroxyurea oral liquid dose administered will be 20mg/kg/day or infants's usual daily dose."
10861967|NCT03825341|FG001|Participant Flow|Arm 2 Hydroxyurea Oral Capsule|"In Arm 2, n=30 children who range in age from 2 to 18 years will be administered oral capsule HU, both a sprinkle formulation and capsules (Droxia® 200 mg), on two separate occasions separated by at least 1 but no more than 30 days in a randomized, crossover fashion. The doses of HU on each occasion will be rounded to the nearest 200 mg and will not exceed 35 mg/kg or 2000 mg~Hydroxyurea Oral Capsule: Drug: Hydroxyurea both a sprinkle formulation and capsules (Droxia 200mg) administered on 2 separate occasions."
10861968|NCT03825341|OG000|Outcome|Arm 1 Liquid Hydroxyurea|"In Arm 1 of this study, n=18 infants ages 9 months to 2 years will be administered an extemporaneous oral liquid formulation of HU on a single occasion followed by PK sampling. The dose administered will be ~20 mg/kg/day or the infant's usual daily dose.~Hydroxyurea: Drug: Hydroxyurea oral liquid dose administered will be 20mg/kg/day or infants's usual daily dose."
10861969|NCT03825341|OG000|Outcome|Arm 2 Hydroxyurea Oral Capsule|"In Arm 2, n=30 children who range in age from 2 to 18 years will be administered oral capsule HU, both a sprinkle formulation and capsules (Droxia® 200 mg), on two separate occasions separated by at least 1 but no more than 30 days in a randomized, crossover fashion. The doses of HU on each occasion will be rounded to the nearest 200 mg and will not exceed 35 mg/kg or 2000 mg~Hydroxyurea Oral Capsule: Drug: Hydroxyurea both a sprinkle formulation and capsules (Droxia 200mg) administered on 2 separate occasions."
10861970|NCT03825341|OG000|Outcome|Arm 1 Liquid Hydroxyurea|In Arm 1 of this study, n=18 infants ages 9 months to 2 years will be administered an extemporaneous oral liquid formulation of HU on a single occasion followed by PK sampling. The dose administered will be ~20 mg/kg/day or the infant's usual daily dose.
10861971|NCT03825341|OG001|Outcome|Arm 2 Hydroxyurea Oral Capsule|"In Arm 2, n=30 children who range in age from 2 to 18 years will be administered oral capsule HU, both a sprinkle formulation and capsules (Droxia® 200 mg), on two separate occasions separated by at least 1 but no more than 30 days in a randomized, crossover fashion. The doses of HU on each occasion will be rounded to the nearest 200 mg and will not exceed 35 mg/kg or 2000 mg~Hydroxyurea Oral Capsule: Drug: Hydroxyurea both a sprinkle formulation and capsules (Droxia 200mg) administered on 2 separate occasions."
10861972|NCT03825341|EG000|Reported Event|Arm 1 Liquid Hydroxyurea|"In Arm 1 of this study, n=18 infants ages 9 months to 2 years will be administered an extemporaneous oral liquid formulation of HU on a single occasion followed by PK sampling. The dose administered will be ~20 mg/kg/day or the infant's usual daily dose.~Hydroxyurea: Drug: Hydroxyurea oral liquid dose administered will be 20mg/kg/day or infants's usual daily dose."
10861973|NCT03825341|EG001|Reported Event|Arm 2 Hydroxyurea Oral Capsule|"In Arm 2, n=30 children who range in age from 2 to 18 years will be administered oral capsule HU, both a sprinkle formulation and capsules (Droxia® 200 mg), on two separate occasions separated by at least 1 but no more than 30 days in a randomized, crossover fashion. The doses of HU on each occasion will be rounded to the nearest 200 mg and will not exceed 35 mg/kg or 2000 mg~Hydroxyurea Oral Capsule: Drug: Hydroxyurea both a sprinkle formulation and capsules (Droxia 200mg) administered on 2 separate occasions."
10861974|NCT03751631|BG000|Baseline|All Participants|Participants were administered each of the 3 assigned drugs on 3 separate days in the clinic (drug administration sequence was equally randomized across 6 possible administration sequences).
10861975|NCT03751631|FG000|Participant Flow|TR/PE - TR - PE|Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%; 3rd Treatment Day - Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
10861976|NCT03751631|FG001|Participant Flow|TR/PE - PE - TR|Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 2nd Treatment Day - Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%. Each drug was administered with the Optejet microdose dispenser.
10861977|NCT03751631|FG002|Participant Flow|TR - TR/PE - PE|Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%; 2nd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 3rd Treatment Day - Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
10861978|NCT03751631|FG003|Participant Flow|TR - PE - TR/PE|Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%; 2nd Treatment Day - Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
11348135|NCT04209530|BG000|Baseline|Buttock|"EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
10861979|NCT03751631|FG004|Participant Flow|PE - TR/PE - TR|Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%. Each drug was administered with the Optejet microdose dispenser.
10861980|NCT03751631|FG005|Participant Flow|PE - TR - TR/PE|Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%; 3rd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
11348136|NCT04209530|BG001|Baseline|Posterolateral Thigh|"EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
10861981|NCT03751631|OG000|Outcome|TR/PE - Right Eye|Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
10861982|NCT03751631|OG001|Outcome|TR/PE - Left Eye|Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
10861983|NCT03751631|OG002|Outcome|TR - Right Eye|Tropicamide 1% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
10861984|NCT03751631|OG003|Outcome|TR - Left Eye|Tropicamide 1% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
10861985|NCT03751631|OG004|Outcome|PE - Right Eye|Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
10861986|NCT03751631|OG005|Outcome|PE - Left Eye|Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
10861987|NCT03751631|EG000|Reported Event|Tropicamide/Phenylephrine|Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
10861988|NCT03751631|EG001|Reported Event|Tropicamide|Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser
10861989|NCT03751631|EG002|Reported Event|Phenylephrine|Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
10861990|NCT03751098|BG000|Baseline|All Participants|Participants were administered the assigned treatments on 3 separate days (treatment administration sequence was randomized).
10861991|NCT03751098|FG000|Participant Flow|1-TR/PE, 2-Placebo, 3-Placebo|Participants were administered the assigned treatment in each eye on separate days in the following order: 1st Treatment Day: Tropicamide 1%/Phenylephrine 2.5%, 2nd Treatment Day: Placebo, 3rd Treatment Day: Placebo. Each treatment was administered with the Optejet microdose dispenser.
10861992|NCT03751098|FG001|Participant Flow|1-Placebo, 2-Placebo, 3-TR/PE|Participants were administered the assigned treatment in each eye on separate days in the following order: 1st Treatment Day: Placebo, 2nd Treatment Day: Placebo, 3rd Treatment Day: Tropicamide 1%/Placebo 2.5%. Each treatment was administered with the Optejet microdose dispenser.
10861993|NCT03751098|OG000|Outcome|TR/PE - Right Eye|Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
10861994|NCT03751098|OG001|Outcome|TR/PE - Left Eye|Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser.
10861995|NCT03751098|OG002|Outcome|Placebo - Right Eye|Placebo ophthalmic solution administered to the right eye with the Optejet microdose dispenser
10861996|NCT03751098|OG003|Outcome|Placebo - Left Eye|Placebo ophthalmic solution administered to the left eye with the Optejet microdose dispenser
10861997|NCT03751098|EG000|Reported Event|Tropicamide/Phenylephrine|Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
10861998|NCT03751098|EG001|Reported Event|Placebo|Placebo ophthalmic solution administered with the Optejet microdose dispenser
10861999|NCT03673345|BG000|Baseline|Cohort 1A|"0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862000|NCT03673345|BG001|Baseline|Cohort 1B|"0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862001|NCT03673345|BG002|Baseline|Cohort 2A|"0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862002|NCT03673345|BG003|Baseline|Cohort 2B|"0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862003|NCT03673345|BG004|Baseline|Cohort 3A|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862004|NCT03673345|BG005|Baseline|Cohort 3B|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10879034|NCT00455195|FG001|Participant Flow|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
11348137|NCT04209530|BG002|Baseline|Total|Total of all reporting groups
11348138|NCT04209530|FG000|Participant Flow|Buttock|"EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
10862005|NCT03673345|BG006|Baseline|Cohort 4A|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862006|NCT03673345|BG007|Baseline|Cohort 4B|"0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862007|NCT03673345|BG008|Baseline|Total|Total of all reporting groups
10862008|NCT03673345|FG000|Participant Flow|Cohort 1A|"0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862009|NCT03673345|FG001|Participant Flow|Cohort 1B|"0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862010|NCT03673345|FG002|Participant Flow|Cohort 2A|"0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862011|NCT03673345|FG003|Participant Flow|Cohort 2B|"0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862012|NCT03673345|FG004|Participant Flow|Cohort 3A|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862013|NCT03673345|FG005|Participant Flow|Cohort 3B|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862014|NCT03673345|FG006|Participant Flow|Cohort 4A|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862015|NCT03673345|FG007|Participant Flow|Cohort 4B|"0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862016|NCT03673345|OG000|Outcome|Cohort 1A|"0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862017|NCT03673345|OG001|Outcome|Cohort 1B|"0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
11348139|NCT04209530|FG001|Participant Flow|Posterolateral Thigh|"EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
10862018|NCT03673345|OG002|Outcome|Cohort 2A|"0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862019|NCT03673345|OG003|Outcome|Cohort 2B|"0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862020|NCT03673345|OG004|Outcome|Cohort 3A|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862021|NCT03673345|OG005|Outcome|Cohort 3B|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862022|NCT03673345|OG006|Outcome|Cohort 4A|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862023|NCT03673345|OG007|Outcome|Cohort 4B|"0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862024|NCT03673345|EG000|Reported Event|Cohort 1A|"0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862025|NCT03673345|EG001|Reported Event|Cohort 1B|"0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862026|NCT03673345|EG002|Reported Event|Cohort 2A|"0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862027|NCT03673345|EG003|Reported Event|Cohort 2B|"0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862028|NCT03673345|EG004|Reported Event|Cohort 3A|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10879035|NCT00455195|OG000|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
11348140|NCT04209530|OG000|Outcome|Buttock|"EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11348141|NCT04209530|OG001|Outcome|Posterolateral Thigh|"EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
10862029|NCT03673345|EG005|Reported Event|Cohort 3B|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862030|NCT03673345|EG006|Reported Event|Cohort 4A|"0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862031|NCT03673345|EG007|Reported Event|Cohort 4B|"0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage)."
10862032|NCT03418675|BG000|Baseline|Placebo|"1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.~Placebo: Pill that contains no medicine"
10862033|NCT03418675|BG001|Baseline|Rexulti|"1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.~Rexulti: Atypical antipsychotic"
10862034|NCT03418675|BG002|Baseline|Total|Total of all reporting groups
10862035|NCT03418675|FG000|Participant Flow|Placebo|"1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.~Placebo: Pill that contains no medicine"
10862036|NCT03418675|FG001|Participant Flow|Rexulti|"1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.~Rexulti: Atypical antipsychotic"
10862037|NCT03418675|OG000|Outcome|Placebo|"1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.~Placebo: Pill that contains no medicine"
10862038|NCT03418675|OG001|Outcome|Rexulti|"1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.~Rexulti: Atypical antipsychotic"
10862039|NCT03418675|EG000|Reported Event|Placebo|"1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.~Placebo: Pill that contains no medicine"
10862040|NCT03418675|EG001|Reported Event|Rexulti|"1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.~Rexulti: Atypical antipsychotic"
10862041|NCT03367910|BG000|Baseline|FMT for MDRO UTI|"Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.~Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema"
10862042|NCT03367910|FG000|Participant Flow|FMT for MDRO UTI|"Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.~Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema"
10862043|NCT03367910|OG000|Outcome|FMT for MDRO UTI|"Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.~Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema"
10862044|NCT03367910|EG000|Reported Event|FMT for MDRO UTI|"Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.~Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema"
10862045|NCT03329690|BG000|Baseline|DS-8201a|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
10862046|NCT03329690|BG001|Baseline|Physician's Choice Irinotecan|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
10862047|NCT03329690|BG002|Baseline|Physician's Choice Paclitaxel|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
10862048|NCT03329690|BG003|Baseline|Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a|Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
10862049|NCT03329690|BG004|Baseline|Exploratory: Naïve HER2 IHC 1+, DS-8201a|Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
10862050|NCT03329690|BG005|Baseline|Total|Total of all reporting groups
10862051|NCT03329690|FG000|Participant Flow|DS-8201a|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
10862052|NCT03329690|FG001|Participant Flow|Physician's Choice Irinotecan|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
10862053|NCT03329690|FG002|Participant Flow|Physician's Choice Paclitaxel|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
11348142|NCT04209530|EG000|Reported Event|Buttock|"EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
10862054|NCT03329690|FG003|Participant Flow|Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a|Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
10862055|NCT03329690|FG004|Participant Flow|Exploratory: Naïve HER2 IHC 1+, DS-8201a|Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
10862056|NCT03329690|OG000|Outcome|DS-8201a|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
10862057|NCT03329690|OG001|Outcome|Physician's Choice Irinotecan|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
10862058|NCT03329690|OG002|Outcome|Physician's Choice Paclitaxel|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
10862059|NCT03329690|OG003|Outcome|Physician's Choice Overall|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
10862060|NCT03329690|OG004|Outcome|Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a|Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
10862061|NCT03329690|OG005|Outcome|Exploratory: Naïve HER2 IHC 1+, DS-8201a|Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
10862062|NCT03329690|OG000|Outcome|Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a|Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
10862063|NCT03329690|OG001|Outcome|Exploratory: Naïve HER2 IHC 1+, DS-8201a|Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
10862064|NCT03329690|OG001|Outcome|Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a|Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
10862065|NCT03329690|OG002|Outcome|Exploratory: Naïve HER2 IHC 1+, DS-8201a|Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
10862066|NCT03329690|EG000|Reported Event|DS-8201a|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
10862067|NCT03329690|EG001|Reported Event|Physician's Choice Irinotecan|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
10862068|NCT03329690|EG002|Reported Event|Physician's Choice Paclitaxel|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
10862069|NCT03329690|EG003|Reported Event|Physician's Choice Overall|Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
10862070|NCT03329690|EG004|Reported Event|Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a|Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
10862071|NCT03329690|EG005|Reported Event|Exploratory: Naïve HER2 IHC 1+, DS-8201a|Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
10862072|NCT03320564|BG000|Baseline|Infiltration|"Repeat F-18 FDG PET~F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration."
10862073|NCT03320564|FG000|Participant Flow|Infiltration|"Repeat F-18 FDG PET~F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration."
10862074|NCT03320564|OG000|Outcome|Infiltration|"Repeat F-18 FDG PET~F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration."
10862075|NCT03320564|EG000|Reported Event|Infiltration|"Repeat F-18 FDG PET~F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration."
10879036|NCT00455195|EG000|Reported Event|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
10879037|NCT00455195|EG001|Reported Event|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double-blind study, started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
10879038|NCT00455195|EG002|Reported Event|Overall|The combined alglucosidase alfa treatment experience from the two treatment groups.
10879039|NCT00455312|BG000|Baseline|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
10977044|NCT00943319|FG000|Participant Flow|Busulfan and Fludarabine|"Intravenous busulfan (Busulfan®) in combination with fludarabine~Busulfan: Daily intravenous dosing to target AVC~Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.~Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).~Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated)."
11348143|NCT04209530|EG001|Reported Event|Posterolateral Thigh|"EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11348144|NCT04209335|BG000|Baseline|Healthy Working Age Population|"isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank)~isometric core muscle endurance testing: holding previously described isometric positions until fatigue"
10862076|NCT03235817|BG000|Baseline|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
10862077|NCT03235817|BG001|Baseline|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862078|NCT03235817|BG002|Baseline|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862079|NCT03235817|BG003|Baseline|Total|Total of all reporting groups
10862080|NCT03235817|FG000|Participant Flow|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
10862081|NCT03235817|FG001|Participant Flow|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862082|NCT03235817|FG002|Participant Flow|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862083|NCT03235817|OG000|Outcome|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
10862084|NCT03235817|OG001|Outcome|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862085|NCT03235817|OG001|Outcome|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862086|NCT03235817|OG000|Outcome|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862087|NCT03235817|EG000|Reported Event|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
10862088|NCT03235817|EG001|Reported Event|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862089|NCT03235817|EG002|Reported Event|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
10862090|NCT03165955|BG000|Baseline|Oraxol (Oral Paclitaxel Plus HM30181)|Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
10862091|NCT03165955|FG000|Participant Flow|Oraxol (Oral Paclitaxel Plus HM30181)|Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
10862092|NCT03165955|OG000|Outcome|Oraxol (Oral Paclitaxel Plus HM30181)|Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
10862093|NCT03165955|EG000|Reported Event|Oraxol (Oral Paclitaxel Plus HM30181)|Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
10862094|NCT03133793|BG000|Baseline|Placebo Only|"Participants in this group will receive placebo pills and placebo powder.~Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862095|NCT03133793|BG001|Baseline|CoQ10 Only|"Participants in this group will receive CoQ10 pills and placebo powder~CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862096|NCT03133793|BG002|Baseline|D-ribose Only|"Participants in this group will receive placebo pills and D-ribose oral powder.~D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.~Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks."
10862097|NCT03133793|BG003|Baseline|CoQ10 + D-ribose|"Participants in this group will receive CoQ10 pills and D-ribose oral powder.~CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862098|NCT03133793|BG004|Baseline|Total|Total of all reporting groups
10862099|NCT03133793|FG000|Participant Flow|Placebo Only|"Participants in this group received placebo pills and placebo powder.~Placebo pills: Participants took matched placebo pills that were 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants mixed 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862100|NCT03133793|FG001|Participant Flow|CoQ10 (Ubiquinol) Only|"Participants in this group received CoQ10 (ubiquinol) capsules and placebo powder~CoQ10 (Ubiquinol): Participants took 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants mixed 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862101|NCT03133793|FG002|Participant Flow|D-ribose Only|"Participants in this group received placebo pills and D-ribose oral powder.~D-Ribose Oral Powder: Participants mixed 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.~Placebo pills: Participants took matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks."
10862102|NCT03133793|FG003|Participant Flow|CoQ10 (Ubiquinol) + D-ribose|"Participants in this group received CoQ10 (ubiquinol) capsules and D-ribose oral powder.~CoQ10 (Ubiquinol): Participants took 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~D-Ribose Oral Powder: Participants mixed 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862103|NCT03133793|OG000|Outcome|Placebo Only|"Participants in this group will receive placebo pills and placebo powder.~Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862104|NCT03133793|OG001|Outcome|CoQ10 Only|"Participants in this group will receive CoQ10 pills and placebo powder~CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862105|NCT03133793|OG002|Outcome|D-ribose Only|"Participants in this group will receive placebo pills and D-ribose oral powder.~D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.~Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks."
10862106|NCT03133793|OG003|Outcome|CoQ10 + D-ribose|"Participants in this group will receive CoQ10 pills and D-ribose oral powder.~CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862107|NCT03133793|OG000|Outcome|Placebo Only|"Participants in this group received placebo pills and placebo powder.~Placebo pills: Participants took matched placebo pills that were 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants mixed 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862108|NCT03133793|OG001|Outcome|CoQ10 (Ubiquinol) Only|"Participants in this group received CoQ10 (ubiquinol) capsules and placebo powder~CoQ10 (Ubiquinol): Participants took 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants mixed 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862109|NCT03133793|OG002|Outcome|D-ribose Only|"Participants in this group received placebo pills and D-ribose oral powder.~D-Ribose Oral Powder: Participants mixed 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.~Placebo pills: Participants took matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks."
10862110|NCT03133793|OG003|Outcome|CoQ10 (Ubiquinol) + D-ribose|"Participants in this group received CoQ10 (ubiquinol) capsules and D-ribose oral powder.~CoQ10 (Ubiquinol): Participants took 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~D-Ribose Oral Powder: Participants mixed 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862111|NCT03133793|EG000|Reported Event|Placebo Only|"Participants in this group will receive placebo pills and placebo powder.~Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862112|NCT03133793|EG001|Reported Event|CoQ10 Only|"Participants in this group will receive CoQ10 pills and placebo powder~CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862113|NCT03133793|EG002|Reported Event|D-ribose Only|"Participants in this group will receive placebo pills and D-ribose oral powder.~D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.~Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks."
10862114|NCT03133793|EG003|Reported Event|CoQ10 + D-ribose|"Participants in this group will receive CoQ10 pills and D-ribose oral powder.~CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.~D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks."
10862115|NCT03103542|BG000|Baseline|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|"Participants will receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 60 Weeks during the ITI Period. Participants who meet the criteria for ITI success will enter a tapering period of 16 weeks where the dose will be tapered down until a prophylactic dose, as judged by the Investigator, is achieved and thereafter a follow-up period of 32 weeks where the patient will continue to receive prophylactic treatment with rFVIIIFc.~Recombinant coagulation factor (rFVIIIFc): rFVIIIFc 200 IU/kg/day during ITI Period and thereafter adjusted according to the Investigator's judgement~administered intravenously."
10862116|NCT03103542|FG000|Participant Flow|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|"Participants received rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 60 Weeks during the ITI Period. Participants who met the criteria for ITI success entered a tapering period of 16 weeks where the dose was tapered down until a prophylactic dose, as judged by the Investigator, was achieved and thereafter a follow-up period of 32 weeks where the patient continued to receive prophylactic treatment with rFVIIIFc.~Recombinant coagulation factor (rFVIIIFc): rFVIIIFc 200 IU/kg/day during ITI Period and thereafter adjusted according to the Investigator's judgement administered intravenously."
10879040|NCT00455312|BG001|Baseline|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
11348145|NCT04209335|FG000|Participant Flow|Healthy Working Age Population|"isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank)~isometric core muscle endurance testing: holding previously described isometric positions until fatigue"
10879041|NCT00455312|BG002|Baseline|Total|Total of all reporting groups
10862117|NCT03103542|OG000|Outcome|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|"Participants will receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 60 Weeks during the ITI Period. Participants who meet the criteria for ITI success will enter a tapering period of 16 weeks where the dose will be tapered down until a prophylactic dose, as judged by the Investigator, is achieved and thereafter a follow-up period of 32 weeks where the patient will continue to receive prophylactic treatment with rFVIIIFc.~Recombinant coagulation factor (rFVIIIFc): rFVIIIFc 200 IU/kg/day during ITI Period and thereafter adjusted according to the Investigator's judgement~administered intravenously."
10862118|NCT03103542|OG000|Outcome|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|"Participants received rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 60 Weeks during the ITI Period. Participants who met the criteria for ITI success entered a tapering period of 16 weeks where the dose was tapered down until a prophylactic dose, as judged by the Investigator, was achieved and thereafter a follow-up period of 32 weeks where the patient continued to receive prophylactic treatment with rFVIIIFc.~Recombinant coagulation factor (rFVIIIFc): rFVIIIFc 200 IU/kg/day during ITI Period and thereafter adjusted according to the Investigator's judgement administered intravenously."
10862119|NCT03103542|EG000|Reported Event|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|"Participants will receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 60 Weeks during the ITI Period. Participants who meet the criteria for ITI success will enter a tapering period of 16 weeks where the dose will be tapered down until a prophylactic dose, as judged by the Investigator, is achieved and thereafter a follow-up period of 32 weeks where the patient will continue to receive prophylactic treatment with rFVIIIFc.~Recombinant coagulation factor (rFVIIIFc): rFVIIIFc 200 IU/kg/day during ITI Period and thereafter adjusted according to the Investigator's judgement~administered intravenously."
10862120|NCT03086317|BG000|Baseline|Standard Catheter-Directed Thrombolysis|"Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.~Standard Catheter-Directed Thrombolysis: Catheter-directed thrombolysis requires placement of a multi-sidehole infusion catheter within the pulmonary arterial thrombus burden, under angiographic guidance. Thrombolytic medications are slowly infused through the catheter, which is left in place for the duration of the treatment. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care."
10862121|NCT03086317|BG001|Baseline|Ultrasound-Accelerated Thrombolysis|"Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.~Ultrasound-Accelerated Thrombolysis: USAT is a modification of standard catheter-directed thrombolysis utilizing a proprietary system of local high frequency, low-power ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytic medication. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care."
10862122|NCT03086317|BG002|Baseline|Total|Total of all reporting groups
10862123|NCT03086317|FG000|Participant Flow|Standard Catheter-Directed Thrombolysis|"Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.~Standard Catheter-Directed Thrombolysis: Catheter-directed thrombolysis requires placement of a multi-sidehole infusion catheter within the pulmonary arterial thrombus burden, under angiographic guidance. Thrombolytic medications are slowly infused through the catheter, which is left in place for the duration of the treatment. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care."
10862124|NCT03086317|FG001|Participant Flow|Ultrasound-Accelerated Thrombolysis|"Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.~Ultrasound-Accelerated Thrombolysis: USAT is a modification of standard catheter-directed thrombolysis utilizing a proprietary system of local high frequency, low-power ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytic medication. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care."
10862125|NCT03086317|OG000|Outcome|Standard Catheter-Directed Thrombolysis|"Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.~Standard Catheter-Directed Thrombolysis: Catheter-directed thrombolysis requires placement of a multi-sidehole infusion catheter within the pulmonary arterial thrombus burden, under angiographic guidance. Thrombolytic medications are slowly infused through the catheter, which is left in place for the duration of the treatment. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care."
11348146|NCT04209335|OG000|Outcome|Healthy Working Age Population|"the sum of 4 isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank on each side)~isometric core muscle endurance testing: holding previously described isometric positions until fatigue"
10862126|NCT03086317|OG001|Outcome|Ultrasound-Accelerated Thrombolysis|"Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.~Ultrasound-Accelerated Thrombolysis: USAT is a modification of standard catheter-directed thrombolysis utilizing a proprietary system of local high frequency, low-power ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytic medication. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care."
10862127|NCT03086317|EG000|Reported Event|Standard Catheter-Directed Thrombolysis|"Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.~Standard Catheter-Directed Thrombolysis: Catheter-directed thrombolysis requires placement of a multi-sidehole infusion catheter within the pulmonary arterial thrombus burden, under angiographic guidance. Thrombolytic medications are slowly infused through the catheter, which is left in place for the duration of the treatment. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care."
10862128|NCT03086317|EG001|Reported Event|Ultrasound-Accelerated Thrombolysis|"Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.~Ultrasound-Accelerated Thrombolysis: USAT is a modification of standard catheter-directed thrombolysis utilizing a proprietary system of local high frequency, low-power ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytic medication. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care."
10862129|NCT02676765|BG000|Baseline|Sublingual Allergen Tablets|"Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.~allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet"
10862130|NCT02676765|BG001|Baseline|Placebo|"Subjects will be administered placebo sublingual tablets~Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet"
10862131|NCT02676765|BG002|Baseline|Total|Total of all reporting groups
10862132|NCT02676765|FG000|Participant Flow|Sublingual Allergen Tablets|"Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.~allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet"
10862133|NCT02676765|FG001|Participant Flow|Placebo|"Subjects will be administered placebo sublingual tablets~Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet"
10862134|NCT02676765|OG000|Outcome|Sublingual Allergen Tablets|"Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.~allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet"
10862135|NCT02676765|OG001|Outcome|Placebo|"Subjects will be administered placebo sublingual tablets~Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet"
10862136|NCT02676765|EG000|Reported Event|Sublingual Allergen Tablets|"Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.~allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet"
10862137|NCT02676765|EG001|Reported Event|Placebo|"Subjects will be administered placebo sublingual tablets~Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet"
10862138|NCT02539563|BG000|Baseline|Peanut Ball|"the peanut shaped birthing ball after labor analgesia will be utilized~peanut shaped birthing ball: peanut ball will be utilized"
10862139|NCT02539563|BG001|Baseline|no Peanut Ball|the peanut shaped birthing ball will not be utilized during labor
10862140|NCT02539563|BG002|Baseline|Total|Total of all reporting groups
10862141|NCT02539563|FG000|Participant Flow|Peanut Ball|"the peanut shaped birthing ball after labor analgesia will be utilized~peanut shaped birthing ball: peanut ball will be utilized"
10862142|NCT02539563|FG001|Participant Flow|no Peanut Ball|the peanut shaped birthing ball will not be utilized during labor
10862143|NCT02539563|OG000|Outcome|Peanut Ball|"the peanut shaped birthing ball after labor analgesia will be utilized~peanut shaped birthing ball: peanut ball will be utilized"
10862144|NCT02539563|OG001|Outcome|no Peanut Ball|the peanut shaped birthing ball will not be utilized during labor
10862145|NCT02539563|EG000|Reported Event|Peanut Ball|"the peanut shaped birthing ball after labor analgesia will be utilized~peanut shaped birthing ball: peanut ball will be utilized"
10862146|NCT02539563|EG001|Reported Event|no Peanut Ball|the peanut shaped birthing ball will not be utilized during labor
10862147|NCT02422446|BG000|Baseline|EPA Arm|"EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day~Icosapent ethyl: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish"
11348147|NCT04209335|OG000|Outcome|Healthy Working Age Population|the body mass index of the participant, at the time of testing
10862148|NCT02422446|BG001|Baseline|Control|Control group will not receive EPA
10862149|NCT02422446|BG002|Baseline|Total|Total of all reporting groups
10862150|NCT02422446|FG000|Participant Flow|EPA Arm|"EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day~Icosapent ethyl: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish"
10862151|NCT02422446|FG001|Participant Flow|Control|Control group will not receive EPA
10862152|NCT02422446|OG000|Outcome|EPA Arm|"EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day~Icosapent ethyl: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish"
10862153|NCT02422446|OG001|Outcome|Control|Control group will not receive EPA
10862154|NCT02422446|EG000|Reported Event|EPA Arm|"EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day~Icosapent ethyl: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish"
10862155|NCT02422446|EG001|Reported Event|Control|Control group will not receive EPA
11348148|NCT04209335|OG000|Outcome|Healthy Working Age Population|Number of active participants who met national and international guidelines
10862156|NCT02362451|BG000|Baseline|1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment|"Cohort 1 All patients to receive autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine before randomization~Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24"
10862157|NCT02362451|BG001|Baseline|2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment|"Cohort 2 Autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine after randomization~Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24"
10862158|NCT02362451|BG002|Baseline|Total|Total of all reporting groups
10862159|NCT02362451|FG000|Participant Flow|1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment|"Cohort 1 All patients to receive autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine before randomization~Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24"
10862160|NCT02362451|FG001|Participant Flow|2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment|"Cohort 2 Autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine after randomization~Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24"
10862161|NCT02362451|OG000|Outcome|1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment|"Cohort 1 All patients to receive autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine before randomization~Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24"
10862162|NCT02362451|OG001|Outcome|2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment|"Cohort 2 Autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine after randomization~Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24"
10862163|NCT02362451|EG000|Reported Event|1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment|"Cohort 1 All patients to receive autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine before randomization~Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24"
10862164|NCT02362451|EG001|Reported Event|2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment|"Cohort 2 Autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine after randomization~Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24"
10862165|NCT02282020|BG000|Baseline|Olaparib 300mg BID|Participants received olaparib twice daily as a 300 mg tablet.
10862166|NCT02282020|BG001|Baseline|Selected Chemotherapy|Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine.
10862167|NCT02282020|BG002|Baseline|Total|Total of all reporting groups
10862168|NCT02282020|FG000|Participant Flow|Olaparib 300mg BID|Participants received olaparib twice daily as a 300 mg tablet.
10862169|NCT02282020|FG001|Participant Flow|Selected Chemotherapy|Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine.
10862170|NCT02282020|OG000|Outcome|Olaparib 300 mg BID|Participants received olaparib twice daily as a 300 mg tablet.
10862171|NCT02282020|OG001|Outcome|Selected Chemotherapy|Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine.
10862172|NCT02282020|EG000|Reported Event|Olaparib 300mg BID|Participants received olaparib twice daily as a 300 mg tablet.
10862173|NCT02282020|EG001|Reported Event|Selected Chemotherapy|Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine.
10862174|NCT02271230|BG000|Baseline|Active Vitamin D + Active Omega-3 Fatty Acids|Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10862175|NCT02271230|BG001|Baseline|Active Vitamin D + Placebo Omega-3 Fatty Acids|Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day
10862176|NCT02271230|BG002|Baseline|Placebo Vitamin D + Active Omega-3 Fatty Acids|Placebo Vitamin D, one capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10862177|NCT02271230|BG003|Baseline|Placebo Vitamin D + Placebo Omega-3 Fatty Acids|Placebo Vitamin D, one capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day
10862178|NCT02271230|BG004|Baseline|Total|Total of all reporting groups
10862179|NCT02271230|FG000|Participant Flow|Active Vitamin D + Active Omega-3 Fatty Acids|Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10862180|NCT02271230|FG001|Participant Flow|Active Vitamin D + Placebo Omega-3 Fatty Acids|Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day
10862181|NCT02271230|FG002|Participant Flow|Placebo Vitamin D + Active Omega-3 Fatty Acids|Placebo Vitamin D, one capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10862182|NCT02271230|FG003|Participant Flow|Placebo Vitamin D + Placebo Omega-3 Fatty Acids|Placebo Vitamin D, one capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day
10862183|NCT02271230|OG000|Outcome|Active Vitamin D|Vitamin D3, one 2000 IU capsule/day
10862184|NCT02271230|OG001|Outcome|Vitamin D Placebo|Vitamin D placebo, one capsule/day
11348149|NCT04209335|OG000|Outcome|Healthy Working Age Population|Number of participants who have experienced nonspecific low back pain
10862185|NCT02271230|OG002|Outcome|Active Omega-3 Fatty Acids|Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
10862186|NCT02271230|OG003|Outcome|Omega-3 Fatty Acids Placebo|Omega-3 fatty acids placebo, one capsule/day
10862187|NCT02271230|EG000|Reported Event|Active Vitamin D|Vitamin D3, one capsule of 2,000 IU/day
10862188|NCT02271230|EG001|Reported Event|Vitamin D Placebo|Vitamin D placebo, 1 capsule/day
10862189|NCT02271230|EG002|Reported Event|Active Omega-3 Fatty Acids|Omacor, 1 g capsule/day Each capsule of Omacor contains 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA)
10862190|NCT02271230|EG003|Reported Event|Omega-3 Fatty Acids Placebo|Omega-3 fatty acids placebo, one capsule/day
10862191|NCT02180724|BG000|Baseline|Previously Treated|Previously treated, N= 92
10862192|NCT02180724|BG001|Baseline|Treatment Naive|Treatment naïve, N=14
10862193|NCT02180724|BG002|Baseline|Total|Total of all reporting groups
10862194|NCT02180724|FG000|Participant Flow|Previously Treated WM Patients|Previously treated WM Patients, Total 92 patients including 87 patients administered 100mg acalabrutinib twice daily, 12 hours apart (BID dosing = total daily dose 200 mg) orally, with or without food, and 5 patients administered 200mg once daily dose (QD) at beginning then switched to 100mg BID thereafter.
10862195|NCT02180724|FG001|Participant Flow|Treatment Naïve WM Patients|Treatment naïve WM Patients, Total 14 patients including 13 patients administered 100mg acalabrutinib twice daily, 12 hours apart (BID dosing = total daily dose 200 mg) orally, with or without food, and 1 patient administered 200mg once daily dose (QD) at beginning then switched to 100mg BID dose thereafter.
10862196|NCT02180724|OG000|Outcome|Previously Treated (N=92)|100 mg BID N=87 + 200 mg QD N= 5
10862197|NCT02180724|OG001|Outcome|Treatment Naive (N=14)|100 mg BID N= 13 + 200 mg QD N=1
10862198|NCT02180724|EG000|Reported Event|Previously Treated|Previously treated, N= 92
10862199|NCT02180724|EG001|Reported Event|Treatment Naïve|Treatment naïve, N=14
10862200|NCT02038777|BG000|Baseline|Monotherapy Cohort: PF-04449913 25 mg|Participants with advanced hematologic malignancies received PF-04449913 25 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862201|NCT02038777|BG001|Baseline|Monotherapy Cohort: PF-04449913 50 mg|Participants with advanced hematologic malignancies received PF-04449913 50 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862202|NCT02038777|BG002|Baseline|Monotherapy Cohort: PF-04449913 100 mg|Participants with advanced hematologic malignancies received PF-04449913 100 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862203|NCT02038777|BG003|Baseline|Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg|Participants with previously untreated AML/high-risk MDS and unfit for intensive chemotherapy, received PF-04449913 100 mg tablets continuously QD from Cycle 1/Day 3 in 28 day cycles and LDAC 20 mg was administered SC twice daily for first 10 days of the 28-day cycles, maximum up to up to 12 cycles or until disease progression or relapse, or participant refusal, or unacceptable toxicity occurs (whichever occurred first).
10862204|NCT02038777|BG004|Baseline|Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin|Participants with previously untreated AML/high-risk MDS and fit for intensive chemotherapy, participants started receiving PF-04449913 100 mg tablets QD from Day -3 up to Day 28 for first induction cycle and then continuously QD from Cycle 1/Day 1 in 28 day cycles for rest of treatment duration along with Cytarabine 100 mg/m^2 was administered daily by continuous IV infusion for first 7 days of Cycle and Daunorubicin 60 mg/m^2 daily IV for first 3 days of Cycle. Participants with <= 5% bone marrow blasts had second cycle of induction. Participants achieving a complete response after the completion of induction therapy were eligible to begin consolidation cycles. During consolidation, participants received PF-04449913 100 mg tablets orally QD in 28 day cycle along with Cytarabine 1g/m^2 QD on Day 1, 3 and 5 of 28 day cycle. Consolidation was of 2 to 4 cycles. Post-consolidation participants received PF-04449913 100 mg tablets orally QD in 28 day cycle for maintenance up to maximum of 6 cycles.
10862205|NCT02038777|BG005|Baseline|Combination Cohort 3: PF-04449913 100 mg + Azacitidine|Participants with untreated AML and eligible for non-intensive chemotherapy received PF-04449913 100 mg tablets orally, continuously QD from Cycle 1/Day 2 in 28 day cycles along with azacitidine 75 mg/m^2/day SC or IV daily on Days 1-7 of each 28-day cycle. Treatment continued for at least 6 cycles, or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862206|NCT02038777|BG006|Baseline|Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg|Participants with myelofibrosis treated with PF-04449913 in B1371013 received the same dose (100 mg) of PF-04449913 as at the time of discontinuation from study B1371013 from Cycle 1/Day 1 until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
11348150|NCT04209335|EG000|Reported Event|Healthy Working Age Population|"the sum of 4 isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank on each side)~isometric core muscle endurance testing: holding previously described isometric positions until fatigue"
10862207|NCT02038777|BG007|Baseline|Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg|Participants with previously untreated AML or high-risk MDS and unfit for intensive chemotherapy received PF-04449913 100 mg tablets continuously QD from Cycle 1/Day 1 in 28 day cycles and LDAC 20 mg SC twice daily for first 10 days of the 28 day cycles, until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862208|NCT02038777|BG008|Baseline|Total|Total of all reporting groups
10862209|NCT02038777|FG000|Participant Flow|Monotherapy Cohort: PF-04449913 (Glasdegib) 25 mg|Participants with advanced hematologic malignancies received PF-04449913 25 milligram (mg) tablets orally, a single dose on Day -5 of Cycle 1 and then continuously once daily (QD) from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862210|NCT02038777|FG001|Participant Flow|Monotherapy Cohort: PF-04449913 50 mg|Participants with advanced hematologic malignancies received PF-04449913 50 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862211|NCT02038777|FG002|Participant Flow|Monotherapy Cohort: PF-04449913 100 mg|Participants with advanced hematologic malignancies received PF-04449913 100 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862212|NCT02038777|FG003|Participant Flow|Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg|Participants with previously untreated acute myeloid leukemia (AML)/high-risk myelodysplastic syndrome (MDS) and unfit for intensive chemotherapy, received PF-04449913 100 mg tablets continuously QD from Cycle 1/Day 3 in 28 day cycles and low dose Ara-cytarabine (LDAC) 20 mg was administered subcutaneously (SC) twice daily for first 10 days of the 28-day cycles, maximum up to up to 12 cycles or until disease progression or relapse, or participant refusal, or unacceptable toxicity occurs (whichever occurred first).
10862213|NCT02038777|FG004|Participant Flow|Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin|Participants with previously untreated AML/high-risk MDS and fit for intensive chemotherapy, participants started receiving PF-04449913 100 mg tablets QD from Day -3 up to Day 28 for first induction cycle and then continuously QD from Cycle 1/Day 1 in 28 day cycles for rest of treatment duration along with Cytarabine 100 mg per square meter (mg/m^2) was administered daily by continuous intravenous (IV) infusion for first 7 days of Cycle and Daunorubicin 60 mg/m^2 daily IV for first 3 days of Cycle. Participants with <= 5% bone marrow blasts had second cycle of induction. Participants achieving a complete response after the completion of induction therapy were eligible to begin consolidation cycles. During consolidation, participants received PF-04449913 100 mg tablets orally QD in 28 day cycle along with Cytarabine 1g/m^2 QD on Day 1, 3 and 5 of 28 day cycle. Consolidation was of 2 to 4 cycles. Post-consolidation participants received PF-04449913 100 mg tablets orally QD in 28 day cycle for maintenance up to maximum of 6 cycles.
10862214|NCT02038777|FG005|Participant Flow|Combination Cohort 3: PF-04449913 100 mg + Azacitidine|Participants with untreated AML and eligible for non-intensive chemotherapy received PF-04449913 100 mg tablets orally, continuously QD from Cycle 1/Day 2 in 28 day cycles along with azacitidine 75 mg/m^2/day SC or IV daily on Days 1-7 of each 28-day cycle. Treatment continued for at least 6 cycles, or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862215|NCT02038777|FG006|Participant Flow|Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg|Participants with myelofibrosis treated with PF-04449913 in B1371013 received the same dose (100 mg) of PF-04449913 as at the time of discontinuation from study B1371013 from Cycle 1/Day 1 until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862216|NCT02038777|FG007|Participant Flow|Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg|Participants with previously untreated AML or high-risk MDS and unfit for intensive chemotherapy received PF-04449913 100 mg tablets continuously QD from Cycle 1/Day 1 in 28 day cycles and LDAC 20 mg SC twice daily for first 10 days of the 28 day cycles, until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862217|NCT02038777|OG000|Outcome|Monotherapy Cohort: PF-04449913 25 mg|Participants with advanced hematologic malignancies received PF-04449913 25 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862218|NCT02038777|OG001|Outcome|Monotherapy Cohort: PF-04449913 50 mg|Participants with advanced hematologic malignancies received PF-04449913 50 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862219|NCT02038777|OG002|Outcome|Monotherapy Cohort: PF-04449913 100 mg|Participants with advanced hematologic malignancies received PF-04449913 100 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862220|NCT02038777|OG000|Outcome|Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg|Participants with previously untreated AML/high-risk MDS and unfit for intensive chemotherapy, received PF-04449913 100 mg tablets continuously QD from Cycle 1/Day 3 in 28 day cycles and LDAC 20 mg was administered SC twice daily for first 10 days of the 28-day cycles, maximum up to up to 12 cycles or until disease progression or relapse, or participant refusal, or unacceptable toxicity occurs (whichever occurred first).
10862221|NCT02038777|OG000|Outcome|Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin|Participants with previously untreated AML/high-risk MDS and fit for intensive chemotherapy, participants started receiving PF-04449913 100 mg tablets QD from Day -3 up to Day 28 for first induction cycle and then continuously QD from Cycle 1/Day 1 in 28 day cycles for rest of treatment duration along with Cytarabine 100 mg/m^2 was administered daily by continuous IV infusion for first 7 days of Cycle and Daunorubicin 60 mg/m^2 daily IV for first 3 days of Cycle. Participants with <= 5% bone marrow blasts had second cycle of induction. Participants achieving a complete response after the completion of induction therapy were eligible to begin consolidation cycles. During consolidation, participants received PF-04449913 100 mg tablets orally QD in 28 day cycle along with Cytarabine 1g/m^2 QD on Day 1, 3 and 5 of 28 day cycle. Consolidation was of 2 to 4 cycles. Post-consolidation participants received PF-04449913 100 mg tablets orally QD in 28 day cycle for maintenance up to maximum of 6 cycles.
10862222|NCT02038777|OG000|Outcome|Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg|Participants with previously untreated AML or high-risk MDS and unfit for intensive chemotherapy received PF-04449913 100 mg tablets continuously QD from Cycle 1/Day 1 in 28 day cycles and LDAC 20 mg SC twice daily for first 10 days of the 28 day cycles, until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862223|NCT02038777|OG000|Outcome|Combination Cohort 3: PF-04449913 100 mg + Azacitidine|Participants with untreated AML and eligible for non-intensive chemotherapy received PF-04449913 100 mg tablets orally, continuously QD from Cycle 1/Day 2 in 28 day cycles along with azacitidine 75 mg/m^2/day SC or IV daily on Days 1-7 of each 28-day cycle. Treatment continued for at least 6 cycles, or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862224|NCT02038777|EG000|Reported Event|Monotherapy Cohort: PF-04449913 25 mg|Participants with advanced hematologic malignancies received PF-04449913 25 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862225|NCT02038777|EG001|Reported Event|Monotherapy Cohort: PF-04449913 50 mg|Participants with advanced hematologic malignancies received PF-04449913 50 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862226|NCT02038777|EG002|Reported Event|Monotherapy Cohort: PF-04449913 100 mg|Participants with advanced hematologic malignancies received PF-04449913 100 mg tablets orally, a single dose on Day -5 of Cycle 1 and then continuously QD from Cycle 1/Day 1 in 28-day cycles, maximum up to 12 cycles or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity (whichever occurred first).
10862227|NCT02038777|EG003|Reported Event|Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg|Participants with previously untreated AML/high-risk MDS and unfit for intensive chemotherapy, received PF-04449913 100 mg tablets continuously QD from Cycle 1/Day 3 in 28 day cycles and LDAC 20 mg was administered SC twice daily for first 10 days of the 28-day cycles, maximum up to up to 12 cycles or until disease progression or relapse, or participant refusal, or unacceptable toxicity occurs (whichever occurred first).
10862228|NCT02038777|EG004|Reported Event|Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin|Participants with previously untreated AML/high-risk MDS and fit for intensive chemotherapy, participants started receiving PF-04449913 100 mg tablets QD from Day -3 up to Day 28 for first induction cycle and then continuously QD from Cycle 1/Day 1 in 28 day cycles for rest of treatment duration along with Cytarabine 100 mg/m^2 was administered daily by continuous IV infusion for first 7 days of Cycle and Daunorubicin 60 mg/m^2 daily IV for first 3 days of Cycle. Participants with <= 5% bone marrow blasts had second cycle of induction. Participants achieving a complete response after the completion of induction therapy were eligible to begin consolidation cycles. During consolidation, participants received PF-04449913 100 mg tablets orally QD in 28 day cycle along with Cytarabine 1g/m^2 QD on Day 1, 3 and 5 of 28 day cycle. Consolidation was of 2 to 4 cycles. Post-consolidation participants received PF-04449913 100 mg tablets orally QD in 28 day cycle for maintenance up to maximum of 6 cycles.
10862229|NCT02038777|EG005|Reported Event|Combination Cohort 3: PF-04449913 100 mg + Azacitidine|Participants with untreated AML and eligible for non-intensive chemotherapy received PF-04449913 100 mg tablets orally, continuously QD from Cycle 1/Day 2 in 28 day cycles along with azacitidine 75 mg/m^2/day SC or IV daily on Days 1-7 of each 28-day cycle. Treatment continued for at least 6 cycles, or until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862230|NCT02038777|EG006|Reported Event|Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg|Participants with myelofibrosis treated with PF-04449913 in B1371013 received the same dose (100 mg) of PF-04449913 as at the time of discontinuation from study B1371013 from Cycle 1/Day 1 until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862231|NCT02038777|EG007|Reported Event|Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg|Participants with previously untreated AML or high-risk MDS and unfit for intensive chemotherapy received PF-04449913 100 mg tablets continuously QD from Cycle 1/Day 1 in 28 day cycles and LDAC 20 mg SC twice daily for first 10 days of the 28 day cycles, until disease progression or relapse, or participant withdrawal, or unacceptable toxicity, or death (whichever occurred first).
10862232|NCT01996449|BG000|Baseline|Amlodipine Then Eplerenone|The subject will be started on Amlodipine 2.5-10 mg daily, which he or she will continue for a period of 8 weeks. After completion of the study procedures, the medication will be discontinued. The subject will be started on Eplerenone 50 - 200 mg daily, which he or she will continue for a period of 8 weeks.
10862233|NCT01996449|BG001|Baseline|Eplerenone Then Amlodipine|The subject will be started on Eplerenone 50 - 200 mg daily, which he or she will continue for a period of 8 weeks. After completion of the study procedures, the medication will be discontinued. The subject will be started on Amlodipine 2.5-10 mg daily, which he or she will continue for a period of 8 weeks.
10862234|NCT01996449|BG002|Baseline|Total|Total of all reporting groups
10862235|NCT01996449|FG000|Participant Flow|Amlodipine Then Eplerenone|The subject will be started on Amlodipine 2.5-10 mg daily, which he or she will continue for a period of 8 weeks. After completion of the study procedures, the medication will be discontinued. The subject will be started on Eplerenone 50 - 200 mg daily, which he or she will continue for a period of 8 weeks.
10862236|NCT01996449|FG001|Participant Flow|Eplerenone Then Amlodipine|The subject will be started on Eplerenone 50 - 200 mg daily, which he or she will continue for a period of 8 weeks. After completion of the study procedures, the medication will be discontinued. The subject will be started on Amlodipine 2.5-10 mg daily, which he or she will continue for a period of 8 weeks.
10862237|NCT01996449|OG000|Outcome|Amlodipine|Analysis independent of sequence. Amlodipine dosage (2.5 -10mg once daily) was titrated every 2 weeks to target BP of < 140/90 mmHg
10862238|NCT01996449|OG001|Outcome|Eplerenone|Analysis independent of sequence. Eplerenone dosage (50-200 mg once daily) was titrated every 2 weeks to target BP of < 140/90 mmHg.
10862239|NCT01996449|OG000|Outcome|Amlodipine|analysis independent of sequence
10862240|NCT01996449|OG001|Outcome|Eplerenone|analysis independent of sequence
10862241|NCT01996449|EG000|Reported Event|Amlodipine|Analysis independent of sequence. Amlodipine dosage (2.5 -10mg once daily) was titrated every 2 weeks to target BP of < 140/90 mmHg
10862242|NCT01996449|EG001|Reported Event|Eplerenone|Analysis independent of sequence. Eplerenone dosage (50 -200mg once daily) was titrated every 2 weeks to target BP of < 140/90 mmHg
10862243|NCT01927419|BG000|Baseline|Nivolumab + Ipilimumab|Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
10862244|NCT01927419|BG001|Baseline|Ipilimumab|Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
10862245|NCT01927419|BG002|Baseline|Total|Total of all reporting groups
10862246|NCT01927419|FG000|Participant Flow|Nivolumab + Ipilimumab|Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
10862247|NCT01927419|FG001|Participant Flow|Ipilimumab|Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
10862248|NCT01927419|OG000|Outcome|Nivolumab + Ipilimumab|Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
10862249|NCT01927419|OG001|Outcome|Ipilimumab|Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
10862250|NCT01927419|EG000|Reported Event|Nivolumab + Ipilimumab|Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
11348151|NCT04207333|BG000|Baseline|All Participants|All participants who completed both conditions in either Period 1 or Period 2 or Period 3 as per randomization schedule.
10862251|NCT01927419|EG001|Reported Event|Ipilimumab|Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
10862252|NCT01924533|BG000|Baseline|Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2|Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
10862253|NCT01924533|BG001|Baseline|Placebo Tablets bd + Paclitaxel 80 mg/m^2|Placebo tablets bd + Paclitaxel 80 mg/m^2
10862254|NCT01924533|BG002|Baseline|Total|Total of all reporting groups
10862255|NCT01924533|FG000|Participant Flow|Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2|Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
10862256|NCT01924533|FG001|Participant Flow|Placebo Tablets bd + Paclitaxel 80 mg/m^2|Placebo tablets bd + Paclitaxel 80 mg/m^2
10862257|NCT01924533|OG000|Outcome|Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2|Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
10862258|NCT01924533|OG001|Outcome|Placebo Tablets bd + Paclitaxel 80 mg/m^2|Placebo tablets bd + Paclitaxel 80 mg/m^2
10862259|NCT01924533|EG000|Reported Event|Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2|Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
10862260|NCT01924533|EG001|Reported Event|Placebo Tablets bd + Paclitaxel 80 mg/m^2|Placebo tablets bd + Paclitaxel 80 mg/m^2
10862261|NCT01856140|BG000|Baseline|1 Million Cells/ml of ALLO-ASC|"1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.~ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection"
10862262|NCT01856140|BG001|Baseline|10 Million Cells/ml of ALLO-ASC|"10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.~ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection"
10862263|NCT01856140|BG002|Baseline|Total|Total of all reporting groups
10862264|NCT01856140|FG000|Participant Flow|1 Million Cells/ml of ALLO-ASC|"1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.~ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection"
10862265|NCT01856140|FG001|Participant Flow|10 Million Cells/ml of ALLO-ASC|"10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.~ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection"
10862266|NCT01856140|OG000|Outcome|1 Million Cells/ml of ALLO-ASC|"1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.~ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection"
10862267|NCT01856140|OG001|Outcome|10 Million Cells/ml of ALLO-ASC|"10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.~ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection"
10862268|NCT01856140|EG000|Reported Event|1 Million Cells/ml of ALLO-ASC|"1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.~ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection"
10862269|NCT01856140|EG001|Reported Event|10 Million Cells/ml of ALLO-ASC|"10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.~ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection"
10879042|NCT00455312|FG000|Participant Flow|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
10879043|NCT00455312|FG001|Participant Flow|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin (ATG), total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
10879561|NCT00458484|BG005|Baseline|Series 2/Dose Level 2: Stereotactic Radiosurgery|"Series II: Radiation will be delivered in 3 fractions: 18 Gy x 3 fractions total dose of 54 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10862270|NCT01773395|BG000|Baseline|GVAX|"GVAX vaccine~Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.~Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.~Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.~GVHD Prevention:~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.~GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria."
10862271|NCT01773395|BG001|Baseline|Placebo|"Placebo~Participants in the Placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.~Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.~Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.~GVHD Prevention:~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.~Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria."
10862272|NCT01773395|BG002|Baseline|Total|Total of all reporting groups
10862273|NCT01773395|FG000|Participant Flow|GVAX|"GVAX vaccine~Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.~Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.~Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.~GVHD Prevention:~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.~GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria."
10862274|NCT01773395|FG001|Participant Flow|Placebo|"Placebo vaccine~Participants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.~Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.~Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.~GVHD Prevention:~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.~Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria."
10862275|NCT01773395|OG000|Outcome|GVAX|"GVAX vaccine~Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.~Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.~Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.~GVHD Prevention:~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.~GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria."
10879044|NCT00455312|OG000|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
11348751|NCT04137783|EG001|Reported Event|Single ABCA3 Mutation|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which indicated single mutations.~no intervention: there is no intervention in this study, only observation."
10862276|NCT01773395|OG001|Outcome|Placebo|"Placebo vaccine~Participants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.~Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.~Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.~GVHD Prevention:~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.~Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria."
10862277|NCT01773395|EG000|Reported Event|GVAX|"GVAX vaccine~Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.~Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.~Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.~GVHD Prevention:~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.~GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria."
10862278|NCT01773395|EG001|Reported Event|Placebo|"Placebo vaccine~Participants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.~Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.~Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.~GVHD Prevention:~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.~Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria."
10862279|NCT01711879|BG000|Baseline|Aflibercept With Laser|"A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks~Aflibercept: Details covered in arm description"
10862280|NCT01711879|BG001|Baseline|Aflibercept|"2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.~Aflibercept: Details covered in arm description"
10862281|NCT01711879|BG002|Baseline|Total|Total of all reporting groups
10862282|NCT01711879|FG000|Participant Flow|Aflibercept With Laser|A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
10862283|NCT01711879|FG001|Participant Flow|Aflibercept|2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
10862284|NCT01711879|OG000|Outcome|Aflibercept With Laser|A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
10862285|NCT01711879|OG001|Outcome|Aflibercept|2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
10862286|NCT01711879|OG000|Outcome|Aflibercept With Laser|"A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks~Aflibercept: Details covered in arm description"
10862287|NCT01711879|OG001|Outcome|Aflibercept|"2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.~Aflibercept: Details covered in arm description"
10862288|NCT01711879|EG000|Reported Event|Aflibercept With Laser|A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
10862289|NCT01711879|EG001|Reported Event|Aflibercept|2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
10862290|NCT01697267|BG000|Baseline|Rituximab Maintenance|"Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper~Rituximab: Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20."
10862291|NCT01697267|BG001|Baseline|Azathioprine Maintenance|"Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation) (200 mg maximum daily dose). Azathioprine withdrawn at month 27.~Azathioprine: Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.~The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily.~If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%."
10862292|NCT01697267|BG002|Baseline|Total|Total of all reporting groups
10862293|NCT01697267|FG000|Participant Flow|Rituximab Maintenance|"Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper~Rituximab: Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20."
10862294|NCT01697267|FG001|Participant Flow|Azathioprine Maintenance|"Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation) (200 mg maximum daily dose). Azathioprine withdrawn at month 27.~Azathioprine: Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.~The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily.~If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%."
10862295|NCT01697267|OG000|Outcome|Rituximab Maintenance|"Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper~Rituximab: Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20."
10862296|NCT01697267|OG001|Outcome|Azathioprine Maintenance|"Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation) (200 mg maximum daily dose). Azathioprine withdrawn at month 27.~Azathioprine: Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.~The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily.~If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%."
10862297|NCT01697267|EG000|Reported Event|Rituximab Maintenance|"Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper~Rituximab: Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20."
10862298|NCT01697267|EG001|Reported Event|Azathioprine Maintenance|"Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation) (200 mg maximum daily dose). Azathioprine withdrawn at month 27.~Azathioprine: Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.~The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily.~If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%."
10862299|NCT01527149|BG000|Baseline|Treatment (Monoclonal Antibody and Combination Chemotherapy)|"COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.~COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.~All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Eligible patients then undergo standard HDC-ASCT.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Ofatumumab: Given IV~Vincristine Sulfate: Given IV"
10862300|NCT01527149|FG000|Participant Flow|Treatment (Monoclonal Antibody and Combination Chemotherapy)|"COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.~COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.~All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Eligible patients then undergo standard HDC-ASCT.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Ofatumumab: Given IV~Vincristine Sulfate: Given IV"
10862301|NCT01527149|OG000|Outcome|Treatment (Monoclonal Antibody and Combination Chemotherapy)|"COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.~COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.~All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Eligible patients then undergo standard HDC-ASCT.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Ofatumumab: Given IV~Vincristine Sulfate: Given IV"
10862302|NCT01527149|EG000|Reported Event|Treatment (Monoclonal Antibody and Combination Chemotherapy)|"COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16.~COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5.~All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Eligible patients then undergo standard HDC-ASCT.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous HDC-ASCT~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Ofatumumab: Given IV~Vincristine Sulfate: Given IV"
10862303|NCT01388920|BG000|Baseline|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
10862304|NCT01388920|BG001|Baseline|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
10862305|NCT01388920|BG002|Baseline|Placebo|Placebo for 6 months
10862306|NCT01388920|BG003|Baseline|Total|Total of all reporting groups
10862307|NCT01388920|FG000|Participant Flow|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
10862308|NCT01388920|FG001|Participant Flow|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
10862309|NCT01388920|FG002|Participant Flow|Placebo|Placebo for 6 monts
10862310|NCT01388920|OG000|Outcome|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
10862311|NCT01388920|OG001|Outcome|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
10862312|NCT01388920|OG002|Outcome|Placebo|Placebo for 6 months
10862313|NCT01388920|EG000|Reported Event|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
10862314|NCT01388920|EG001|Reported Event|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
10862315|NCT01388920|EG002|Reported Event|Placebo|Placebo for 6 months
10862316|NCT01164202|BG000|Baseline|Placebo|"placebo 3cps/days 4 weeks over 6 during 1 year~Placebo: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: Chemoembolisation"
10862317|NCT01164202|BG001|Baseline|Sunitinib|"sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year~sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: Chemoembolisation"
10862318|NCT01164202|BG002|Baseline|Total|Total of all reporting groups
10862319|NCT01164202|FG000|Participant Flow|Placebo|"placebo 3cps/days 4 weeks over 6 during 1 year~Placebo: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: Chemoembolisation"
10862320|NCT01164202|FG001|Participant Flow|Sunitinib|"sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year~sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: Chemoembolisation"
10862321|NCT01164202|OG000|Outcome|Placebo|"placebo 3cps/days 4 weeks over 6 during 1 year~Placebo: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: Chemoembolisation"
10862322|NCT01164202|OG001|Outcome|Sunitinib|"sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year~sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: Chemoembolisation"
10862323|NCT01164202|OG000|Outcome|Placebo|"placebo 3cps/days 4 weeks over 6 during 1 year~Placebo: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: chemoembolization"
10862324|NCT01164202|OG001|Outcome|Sunitinib|"sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year~sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: chemoembolization"
10862325|NCT01164202|EG000|Reported Event|Sunitinib|"sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year~sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: chemoembolization"
10862326|NCT01164202|EG001|Reported Event|Placebo|"placebo 3cps/days 4 weeks over 6 during 1 year~Placebo: placebo 3cps/days 4 weeks over 6 during 1 year~transarterial chemoembolization: chemoembolization"
10879045|NCT00455312|OG001|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
10879046|NCT00455312|EG000|Reported Event|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
10879047|NCT00455312|EG001|Reported Event|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
10879048|NCT00455429|BG000|Baseline|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
10879049|NCT00455429|BG001|Baseline|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
10879050|NCT00455429|BG002|Baseline|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
10879051|NCT00455429|BG003|Baseline|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
10879052|NCT00455429|BG004|Baseline|Total|Total of all reporting groups
10879053|NCT00455429|FG000|Participant Flow|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
10879054|NCT00455429|FG001|Participant Flow|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
10862327|NCT00554840|BG000|Baseline|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
10862328|NCT00554840|BG001|Baseline|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
10862329|NCT00554840|BG002|Baseline|Total|Total of all reporting groups
10862330|NCT00554840|FG000|Participant Flow|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
10862331|NCT00554840|FG001|Participant Flow|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
10862332|NCT00554840|OG000|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
10862333|NCT00554840|OG001|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
10862334|NCT00554840|OG000|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
10862335|NCT00554840|OG001|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
10862336|NCT00554840|EG000|Reported Event|Varenicline|Subjects randomized to receive active drug (varenicline) will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
10862337|NCT00554840|EG001|Reported Event|Placebo|Subjects randomized to matching placebo will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
10862338|NCT00003656|BG000|Baseline|Phase 1 Group|Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
10862339|NCT00003656|BG001|Baseline|Phase 2 Group|Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
10862340|NCT00003656|BG002|Baseline|Total|Total of all reporting groups
10862341|NCT00003656|FG000|Participant Flow|Phase 1 Group|Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
10862342|NCT00003656|FG001|Participant Flow|Phase 2 Group|Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
10862343|NCT00003656|OG000|Outcome|Phase 1 Group|Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
10862344|NCT00003656|OG001|Outcome|Phase 2 Group|Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
10862345|NCT00003656|OG000|Outcome|All Subjects|"Weekly ATRA-IV with recombinant interferon alfa~recombinant interferon alfa~tretinoin liposome"
10862346|NCT00003656|EG000|Reported Event|Phase 1 Group|Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
10862347|NCT00003656|EG001|Reported Event|Phase 2 Group|Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
10862348|NCT00370331|BG000|Baseline|Placebo|Matching placebo tablets taken once a day
10862349|NCT00370331|BG001|Baseline|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
10862350|NCT00370331|BG002|Baseline|Total|Total of all reporting groups
10862351|NCT00370331|FG000|Participant Flow|Placebo|Matching placebo tablets taken once a day
10862352|NCT00370331|FG001|Participant Flow|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
10862353|NCT00370331|OG000|Outcome|Placebo|Matching placebo tablets taken once a day
10862354|NCT00370331|OG001|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
10862355|NCT00370331|EG000|Reported Event|Placebo|Matching placebo tablets taken once a day
10862356|NCT00370331|EG001|Reported Event|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
10879055|NCT00455429|FG002|Participant Flow|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
10879056|NCT00455429|FG003|Participant Flow|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
10879057|NCT00455429|OG000|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
10862357|NCT00370396|BG000|Baseline|Synflorix-Synflorix Group|This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862358|NCT00370396|BG001|Baseline|Prevenar-Prevenar Group|This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862359|NCT00370396|BG002|Baseline|Prevenar-Synflorix Group|This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862360|NCT00370396|BG003|Baseline|Total|Total of all reporting groups
10862361|NCT00370396|FG000|Participant Flow|Synflorix-Synflorix Group|This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862362|NCT00370396|FG001|Participant Flow|Prevenar-Prevenar Group|This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862363|NCT00370396|FG002|Participant Flow|Prevenar-Synflorix Group|This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862364|NCT00370396|OG000|Outcome|Synflorix-Synflorix Group|This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862365|NCT00370396|OG001|Outcome|Prevenar-Prevenar Group|This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10879058|NCT00455429|OG001|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
10879059|NCT00455429|OG002|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
10879060|NCT00455429|OG003|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
10879061|NCT00455429|OG000|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
10879062|NCT00455429|OG001|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
10862366|NCT00370396|OG002|Outcome|Prevenar-Synflorix Group|This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862367|NCT00370396|EG000|Reported Event|Synflorix-Synflorix Group|This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862368|NCT00370396|EG001|Reported Event|Prevenar-Prevenar Group|This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862369|NCT00370396|EG002|Reported Event|Prevenar-Synflorix Group|This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.
10862370|NCT00370552|BG000|Baseline|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862371|NCT00370552|BG001|Baseline|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862372|NCT00370552|BG002|Baseline|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862373|NCT00370552|BG003|Baseline|Total|Total of all reporting groups
10862374|NCT00370552|FG000|Participant Flow|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862375|NCT00370552|FG001|Participant Flow|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862376|NCT00370552|FG002|Participant Flow|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10879063|NCT00455429|OG002|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
10879064|NCT00455429|EG000|Reported Event|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
10862377|NCT00370552|OG000|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862378|NCT00370552|OG001|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862379|NCT00370552|OG002|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862380|NCT00370552|EG000|Reported Event|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone, as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862381|NCT00370552|EG001|Reported Event|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity. After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone, as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862382|NCT00370552|EG002|Reported Event|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
10862383|NCT00370682|BG000|Baseline|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862384|NCT00370682|BG001|Baseline|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862385|NCT00370682|BG002|Baseline|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862386|NCT00370682|BG003|Baseline|Total|Total of all reporting groups
10862387|NCT00370682|FG000|Participant Flow|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862388|NCT00370682|FG001|Participant Flow|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862389|NCT00370682|FG002|Participant Flow|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862390|NCT00370682|OG000|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862391|NCT00370682|OG001|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862392|NCT00370682|OG002|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862393|NCT00370682|OG000|Outcome|PRE Dose|Pre-dose 1
10862394|NCT00370682|OG001|Outcome|PI (M1)|Post dose1 , Month 1
10862395|NCT00370682|OG002|Outcome|PII (M7)|Post dose 2, Month 7
10862396|NCT00370682|OG003|Outcome|PII (M9)|Post dose 2, Month 9
10862397|NCT00370682|EG000|Reported Event|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862398|NCT00370682|EG001|Reported Event|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10879065|NCT00455429|EG001|Reported Event|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
10862399|NCT00370682|EG002|Reported Event|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
10862400|NCT00370838|BG000|Baseline|Levetiracetam First, Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).~In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
10862401|NCT00370838|BG001|Baseline|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).~In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
10862402|NCT00370838|BG002|Baseline|Total|Total of all reporting groups
10862403|NCT00370838|FG000|Participant Flow|First Levetiracetam Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).~In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
10862404|NCT00370838|FG001|Participant Flow|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).~In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
10862405|NCT00370838|OG000|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
10862406|NCT00370838|OG001|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
10862407|NCT00370838|EG000|Reported Event|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
10862408|NCT00370838|EG001|Reported Event|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
10862409|NCT00370994|BG000|Baseline|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
10862410|NCT00370994|BG001|Baseline|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
10862411|NCT00370994|BG002|Baseline|Total|Total of all reporting groups
10862412|NCT00370994|FG000|Participant Flow|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution.
10879066|NCT00455429|EG002|Reported Event|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
10862413|NCT00370994|FG001|Participant Flow|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
10862414|NCT00370994|OG000|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
10862415|NCT00370994|OG001|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
10862416|NCT00370994|EG000|Reported Event|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
10862417|NCT00370994|EG001|Reported Event|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
10862418|NCT00371137|BG000|Baseline|Placebo|Placebo taken as two equally divided nightly doses
10862419|NCT00371137|BG001|Baseline|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
10862420|NCT00371137|BG002|Baseline|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
10862421|NCT00371137|BG003|Baseline|Total|Total of all reporting groups
10862422|NCT00371137|FG000|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
10862423|NCT00371137|FG001|Participant Flow|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
10862424|NCT00371137|FG002|Participant Flow|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
10862425|NCT00371137|OG000|Outcome|Placebo|Placebo taken as two equally divided nightly doses
10862426|NCT00371137|OG001|Outcome|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
10862427|NCT00371137|OG002|Outcome|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
10862428|NCT00371137|EG000|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
10862429|NCT00371137|EG001|Reported Event|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
10862430|NCT00371137|EG002|Reported Event|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
10862431|NCT00371150|BG000|Baseline|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862432|NCT00371150|BG001|Baseline|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862433|NCT00371150|BG002|Baseline|Total|Total of all reporting groups
10862434|NCT00371150|FG000|Participant Flow|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862435|NCT00371150|FG001|Participant Flow|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862436|NCT00371150|OG000|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862437|NCT00371150|OG001|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
10862438|NCT00371150|OG000|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862439|NCT00371150|OG001|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862440|NCT00371150|OG001|Outcome|Hispanic|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862441|NCT00371150|OG002|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
10862442|NCT00371150|OG001|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
10862443|NCT00371150|EG000|Reported Event|Entecavir (ETV)|Entecavir tablets, Oral, 0.5 mg, once daily, up to 48 weeks (Includes 6 participants of the Hispanic cohort)
10862444|NCT00371176|BG000|Baseline|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
10862445|NCT00371176|BG001|Baseline|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
10862446|NCT00371176|BG002|Baseline|Total|Total of all reporting groups
10862447|NCT00371176|FG000|Participant Flow|D-Cycloserine Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a 50 mg DCS pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
10862448|NCT00371176|FG001|Participant Flow|Placebo Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a placebo pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
10862449|NCT00371176|OG000|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
10862450|NCT00371176|OG001|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
10862451|NCT00371176|EG000|Reported Event|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
10862452|NCT00371176|EG001|Reported Event|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
10862453|NCT00371254|BG000|Baseline|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10862454|NCT00371254|BG001|Baseline|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10862455|NCT00371254|BG002|Baseline|Total|Total of all reporting groups
10879067|NCT00455429|EG003|Reported Event|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
10862456|NCT00371254|FG000|Participant Flow|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10862457|NCT00371254|FG001|Participant Flow|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10862458|NCT00371254|OG000|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10862459|NCT00371254|OG001|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10862460|NCT00371254|OG002|Outcome|Dasatinib 50 mg BID|Participants were administered an oral dose of 50 mg dasatinib tablet twice daily for a total daily dose (TDD) of 100 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10862461|NCT00371254|EG000|Reported Event|All Participants|All treated participants who were administered a twice-daily oral dose of either 100 mg (TDD 200 mg) or 70 mg (TDD 140 mg) dasatinib tablet. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10862462|NCT00371267|BG000|Baseline|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
10862463|NCT00371267|BG001|Baseline|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
10862464|NCT00371267|BG002|Baseline|Total|Total of all reporting groups
10862465|NCT00371267|FG000|Participant Flow|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
10862466|NCT00371267|FG001|Participant Flow|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
10862467|NCT00371267|OG000|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
10862468|NCT00371267|OG001|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
10862469|NCT00371267|EG000|Reported Event|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
10862470|NCT00371267|EG001|Reported Event|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
10862471|NCT00371293|BG000|Baseline|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
10862472|NCT00371293|BG001|Baseline|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
10862473|NCT00371293|BG002|Baseline|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
10862474|NCT00371293|BG003|Baseline|Total|Total of all reporting groups
10862475|NCT00371293|FG000|Participant Flow|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
10862476|NCT00371293|FG001|Participant Flow|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
10862477|NCT00371293|FG002|Participant Flow|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
10862478|NCT00371293|OG000|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
10862479|NCT00371293|OG001|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
10879068|NCT00455455|BG000|Baseline|Entire Study Group|includes groups randomized to use RepleniSH in the 1st period and ReNu in the 2nd period, and first use ReNu and use RepleniSH in the second period.
10862480|NCT00371293|OG002|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
10862481|NCT00371293|OG001|Outcome|Weight Loss - Adherent|"Participants will receive take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
10862482|NCT00371293|EG000|Reported Event|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
10862483|NCT00371293|EG001|Reported Event|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
10862484|NCT00371293|EG002|Reported Event|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
10862485|NCT00371345|BG000|Baseline|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
10862486|NCT00371345|BG001|Baseline|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
10862487|NCT00371345|BG002|Baseline|Total|Total of all reporting groups
10862488|NCT00371345|FG000|Participant Flow|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
10862489|NCT00371345|FG001|Participant Flow|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
10862490|NCT00371345|OG000|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
10862491|NCT00371345|OG001|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
10862492|NCT00371345|OG002|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
10862493|NCT00371345|OG003|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
10862494|NCT00371345|OG001|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
10862495|NCT00371345|OG004|Outcome|All Response-evaluable Participants|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).
10862496|NCT00371345|OG000|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)-amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
10862497|NCT00371345|OG001|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu-amplified]) received orally dasatinib twice daily (BID).
10862498|NCT00371345|OG002|Outcome|All Participants|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
10862499|NCT00371345|OG000|Outcome|Participant CA180088-18-88009, HER-2 Group|Participant with Human epidermal growth factor (Her2/neu)-amplified tumor type (also positive for ER and PgR) who received 100 mg dasatinib BID.
10862500|NCT00371345|OG001|Outcome|Participant CA180088-16-88002, ER and/or PgR Group|Participant with ER and PgR-amplified tumor type who received 100 mg dasatinib BID
10862501|NCT00371345|OG002|Outcome|Participant CA180088-29-88085, ER and/or PgR Group|Participant with ER and PgR-amplified tumor type who received 70 mg dasatinib BID
10862502|NCT00371345|OG000|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
10862503|NCT00371345|OG001|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
10862504|NCT00371345|OG000|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
10862505|NCT00371345|OG001|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
10862506|NCT00371345|OG002|Outcome|Dasatinib 50 mg|Dasatinib was administered orally at a starting dose of 70 mg BID. Dose adjustment was made according to tolerance, with reduction to 50 mg BID. Participants continued study treatment until PD or unacceptable toxicity. Dasatinib dose was adjusted so that drug-related toxicities were either Grade 0 - 1 or were Grade 2 toxicities that were adequately managed with outpatient therapy or deemed clinically acceptable.
10862507|NCT00371345|EG000|Reported Event|Dasatinib|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
10862508|NCT00371397|BG000|Baseline|Overall Study|Women were exposed to each of the conditions (yoga, movement control, and passive-video control) during three separate visits. The order of the visits was randomized per participant. 52 total participants enrolled.
10862509|NCT00371397|FG000|Participant Flow|Expert: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
10862510|NCT00371397|FG001|Participant Flow|Expert: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
10862511|NCT00371397|FG002|Participant Flow|Expert: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga Class in 1 day and a 30 minute follow-up session the next morning."
10862512|NCT00371397|FG003|Participant Flow|Expert: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
10862513|NCT00371397|FG004|Participant Flow|Expert: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
10862514|NCT00371397|FG005|Participant Flow|Expert: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
10862515|NCT00371397|FG006|Participant Flow|Novice: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
10862516|NCT00371397|FG007|Participant Flow|Novice: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
10879069|NCT00455455|FG000|Participant Flow|RepleniSH First, Then ReNu|Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period)
10879070|NCT00455455|FG001|Participant Flow|ReNu First, Then RepleniSH|Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period)
10879071|NCT00455455|OG000|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
10862517|NCT00371397|FG008|Participant Flow|Novice: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
10862518|NCT00371397|FG009|Participant Flow|Novice: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
10862519|NCT00371397|FG010|Participant Flow|Novice: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity."
10862520|NCT00371397|FG011|Participant Flow|Novice: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
10862521|NCT00371397|OG000|Outcome|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
10862522|NCT00371397|OG001|Outcome|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
10862523|NCT00371397|EG000|Reported Event|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
10862524|NCT00371397|EG001|Reported Event|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
10862525|NCT00371436|BG000|Baseline|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
10862526|NCT00371436|BG001|Baseline|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
10862527|NCT00371436|BG002|Baseline|Total|Total of all reporting groups
10862528|NCT00371436|FG000|Participant Flow|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
10862529|NCT00371436|FG001|Participant Flow|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
10862530|NCT00371436|OG000|Outcome|Arm 1|"Tinnitus Progressive Management~Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
10862531|NCT00371436|OG001|Outcome|Arm 2|"Usual Care~Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic."
10862532|NCT00371436|EG000|Reported Event|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
10862533|NCT00371436|EG001|Reported Event|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
10862534|NCT00371449|BG000|Baseline|Hearing Aid Users|Hearing aid users
10862535|NCT00371449|FG000|Participant Flow|Hearing-Aid Users|Individuals who wore hearing aids for > 3 months and at their current setting for at least 1 month
10862536|NCT00371449|OG000|Outcome|Group 1|hearing aid users
10862537|NCT00371449|OG000|Outcome|Hearing-aid Users|hearing aid users
10862538|NCT00371449|OG000|Outcome|Hearing Aid Users|hearing aid users
10862539|NCT00371449|EG000|Reported Event|Hearing-aid Users|
10862540|NCT00371540|BG000|Baseline|I Routine Care|Routine care in the clinic
10862541|NCT00371540|BG001|Baseline|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly~Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
10862542|NCT00371540|BG002|Baseline|Total|Total of all reporting groups
10862543|NCT00371540|FG000|Participant Flow|I Routine Care|Routine care in the clinic
10862544|NCT00371540|FG001|Participant Flow|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly~Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
10862545|NCT00371540|OG000|Outcome|I Rountine Care|
10862546|NCT00371540|OG001|Outcome|II Home Visits|
10862547|NCT00371540|EG000|Reported Event|I Rountine Care|
10862548|NCT00371540|EG001|Reported Event|II Home Visits|
10862549|NCT00371566|BG000|Baseline|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
10862550|NCT00371566|BG001|Baseline|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
10862551|NCT00371566|BG002|Baseline|Total|Total of all reporting groups
10862552|NCT00371566|FG000|Participant Flow|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the institutions standard of care)
10862553|NCT00371566|FG001|Participant Flow|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
10862554|NCT00371566|OG000|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
10862555|NCT00371566|OG001|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
10862556|NCT00371566|EG000|Reported Event|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
10862557|NCT00371566|EG001|Reported Event|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of mor than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
10862558|NCT00371631|BG000|Baseline|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
10862559|NCT00371631|FG000|Participant Flow|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
10862560|NCT00371631|OG000|Outcome|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
10862561|NCT00371631|EG000|Reported Event|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
10862562|NCT00371644|BG000|Baseline|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
10862563|NCT00371644|BG001|Baseline|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
10862564|NCT00371644|BG002|Baseline|Total|Total of all reporting groups
10862565|NCT00371644|FG000|Participant Flow|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
10862566|NCT00371644|FG001|Participant Flow|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
10879072|NCT00455455|OG001|Outcome|ReNu|Use ReNu for lens care in either first period or second period
10879073|NCT00455455|OG001|Outcome|ReNu|use ReNu for lens care in either first period or second period
10879074|NCT00455455|OG000|Outcome|RepleniSH|use RepleniSH for lens care in the first period and the second period
10862567|NCT00371644|OG000|Outcome|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
10862568|NCT00371644|OG001|Outcome|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
10862569|NCT00371644|EG000|Reported Event|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
10862570|NCT00371644|EG001|Reported Event|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
10862571|NCT00371683|BG000|Baseline|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
10862572|NCT00371683|BG001|Baseline|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
10862573|NCT00371683|BG002|Baseline|Total|Total of all reporting groups
10862574|NCT00371683|FG000|Participant Flow|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug (day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
10862575|NCT00371683|FG001|Participant Flow|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug(day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
10862576|NCT00371683|OG000|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, ± 2 days.
10862577|NCT00371683|OG001|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
10862578|NCT00371683|OG000|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
10862579|NCT00371683|OG001|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus placebo tablets BID for 12 days, ± 2 days.
10862580|NCT00371683|OG001|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
10862581|NCT00371683|OG001|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
10862582|NCT00371683|OG001|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days,± 2 days.
10862583|NCT00371683|OG000|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
10862584|NCT00371683|OG001|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
10862585|NCT00371683|OG000|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
10862586|NCT00371683|OG001|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
10862587|NCT00371683|OG000|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
10879075|NCT00455455|OG001|Outcome|ReNu|use ReNu for lens care in the first period or the second period
10879076|NCT00455455|EG000|Reported Event|RepleniSH|use RepleniSH for lens care in either first period or second period
10879077|NCT00455455|EG001|Reported Event|ReNu|use ReNu for lens care in either first period or second period
10862588|NCT00371683|EG000|Reported Event|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
10862589|NCT00371683|EG001|Reported Event|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
10862590|NCT00371761|BG000|Baseline|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
10862591|NCT00371761|BG001|Baseline|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
10862592|NCT00371761|BG002|Baseline|Total|Total of all reporting groups
10862593|NCT00371761|FG000|Participant Flow|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
10862594|NCT00371761|FG001|Participant Flow|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
10862595|NCT00371761|OG000|Outcome|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
10862596|NCT00371761|OG001|Outcome|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
10862597|NCT00371761|EG000|Reported Event|PegIntron|
10862598|NCT00371761|EG001|Reported Event|Adefovir|
10862599|NCT00371787|BG000|Baseline|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
10862600|NCT00371787|BG001|Baseline|Control Group|normal non-lens wearers
10862601|NCT00371787|BG002|Baseline|Total|Total of all reporting groups
10862602|NCT00371787|FG000|Participant Flow|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
10862603|NCT00371787|FG001|Participant Flow|Control Group|normal non-lens wearers
10862604|NCT00371787|OG000|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
10862605|NCT00371787|OG001|Outcome|Control Group|normal non-lens wearers
10862606|NCT00371787|EG000|Reported Event|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
10862607|NCT00371787|EG001|Reported Event|Control Group|normal non-lens wearers
10862608|NCT00371826|BG000|Baseline|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
10862609|NCT00371826|BG001|Baseline|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
10862610|NCT00371826|BG002|Baseline|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
10862611|NCT00371826|BG003|Baseline|Total|Total of all reporting groups
10862612|NCT00371826|FG000|Participant Flow|Calcineurin Inhibitor (CNI) Withdrawal|Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day
10862613|NCT00371826|FG001|Participant Flow|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
10879078|NCT00455520|BG000|Baseline|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
10862614|NCT00371826|FG002|Participant Flow|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
10862615|NCT00371826|OG000|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
10862616|NCT00371826|OG001|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
10862617|NCT00371826|OG002|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
10862618|NCT00371826|EG000|Reported Event|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
10862619|NCT00371826|EG001|Reported Event|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
10862620|NCT00371826|EG002|Reported Event|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
10862621|NCT00371839|BG000|Baseline|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862622|NCT00371839|BG001|Baseline|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862623|NCT00371839|BG002|Baseline|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862624|NCT00371839|BG003|Baseline|Total|Total of all reporting groups
10862625|NCT00371839|FG000|Participant Flow|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862626|NCT00371839|FG001|Participant Flow|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862627|NCT00371839|FG002|Participant Flow|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862628|NCT00371839|OG000|Outcome|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862629|NCT00371839|OG001|Outcome|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862630|NCT00371839|OG002|Outcome|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862631|NCT00371839|EG000|Reported Event|Arm 1|"Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
10862632|NCT00371865|BG000|Baseline|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
10862633|NCT00371865|BG001|Baseline|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
10862634|NCT00371865|BG002|Baseline|Total|Total of all reporting groups
10862635|NCT00371865|FG000|Participant Flow|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
10862636|NCT00371865|FG001|Participant Flow|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
10862637|NCT00371865|OG000|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
10862638|NCT00371865|OG001|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
10862639|NCT00371865|EG000|Reported Event|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
10862640|NCT00371865|EG001|Reported Event|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
10862641|NCT00372060|BG000|Baseline|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
10862642|NCT00372060|BG001|Baseline|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
10862643|NCT00372060|BG002|Baseline|Total|Total of all reporting groups
10862644|NCT00372060|FG000|Participant Flow|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
10862645|NCT00372060|FG001|Participant Flow|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
10862646|NCT00372060|OG000|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
10862647|NCT00372060|OG001|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
10862648|NCT00372060|OG000|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) orally once daily who were in the CP. This column of data reflects the change from Week 0 at Week 52.
10879079|NCT00455520|BG001|Baseline|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
10862649|NCT00372060|OG001|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily and who received at least one dose of sitagliptin and were in the CP. This column of data reflects the change from Week 12 at Week 52.
10862650|NCT00372060|EG000|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin orally once daily (Weeks 0-52). This column of data includes only Weeks 0-12.
10862651|NCT00372060|EG001|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily. This column of data includes only Weeks 0-12.
10862652|NCT00372060|EG002|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all patients who took sitagliptin in either treatment group. Includes data from Week 0 to Week 52 for patients in the Sitagliptin/Sitagliptin group and data from Week 12 to Week 52 for patients in the Placebo/Sitagliptin group. Includes patients (from either group) who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
10862653|NCT00372112|BG000|Baseline|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862654|NCT00372112|BG001|Baseline|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862655|NCT00372112|BG002|Baseline|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862656|NCT00372112|BG003|Baseline|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862657|NCT00372112|BG004|Baseline|Total|Total of all reporting groups
10862658|NCT00372112|FG000|Participant Flow|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862659|NCT00372112|FG001|Participant Flow|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862660|NCT00372112|FG002|Participant Flow|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862661|NCT00372112|FG003|Participant Flow|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862662|NCT00372112|OG000|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862663|NCT00372112|OG001|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10879080|NCT00455520|BG002|Baseline|Total|Total of all reporting groups
10862664|NCT00372112|OG002|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862665|NCT00372112|OG003|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862666|NCT00372112|OG000|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862667|NCT00372112|OG001|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862668|NCT00372112|OG000|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862669|NCT00372112|EG000|Reported Event|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862670|NCT00372112|EG001|Reported Event|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862671|NCT00372112|EG002|Reported Event|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862672|NCT00372112|EG003|Reported Event|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
10862673|NCT00372190|BG000|Baseline|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
10862674|NCT00372190|BG001|Baseline|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
10862675|NCT00372190|BG002|Baseline|Total|Total of all reporting groups
10862676|NCT00372190|FG000|Participant Flow|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit.~95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion"
10862677|NCT00372190|FG001|Participant Flow|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse~99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery"
10862678|NCT00372190|OG000|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit.~95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion"
10862679|NCT00372190|OG001|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse~99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery"
10862680|NCT00372190|OG000|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
10862681|NCT00372190|OG001|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
10862682|NCT00372190|EG000|Reported Event|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
10862683|NCT00372190|EG001|Reported Event|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
10862684|NCT00372255|BG000|Baseline|Influsplit SSW 2005/2006 6-9 Years Group|Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
10862685|NCT00372255|BG001|Baseline|Influsplit SSW 2005/2006 10-13 Years Group|Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
10862686|NCT00372255|BG002|Baseline|Total|Total of all reporting groups
10862687|NCT00372255|FG000|Participant Flow|Influsplit SSW 2005/2006 6-9 Years Group|Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
10862688|NCT00372255|FG001|Participant Flow|Influsplit SSW 2005/2006 10-13 Years Group|Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
10862689|NCT00372255|OG000|Outcome|Influsplit SSW 2005/2006 6-9 Years Group|Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
10862690|NCT00372255|OG000|Outcome|Influsplit SSW 2005/2006 10-13 Years Group|Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
10862691|NCT00372255|OG001|Outcome|Influsplit SSW 2005/2006 10-13 Years Group|Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
10862692|NCT00372255|EG000|Reported Event|Influsplit SSW 2005/2006 6-9 Years Group|Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
10862693|NCT00372255|EG001|Reported Event|Influsplit SSW 2005/2006 10-13 Years Group|Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
10862694|NCT00372385|BG000|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10862695|NCT00372385|BG001|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
10862696|NCT00372385|BG002|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
10862697|NCT00372385|BG003|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
10862698|NCT00372385|BG004|Baseline|Total|Total of all reporting groups
10862699|NCT00372385|FG000|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10862700|NCT00372385|FG001|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
10862701|NCT00372385|FG002|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
10862702|NCT00372385|FG003|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
10862703|NCT00372385|OG000|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10862704|NCT00372385|OG001|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
10879081|NCT00455520|FG000|Participant Flow|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
10879082|NCT00455520|FG001|Participant Flow|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
10879083|NCT00455520|OG000|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
10862705|NCT00372385|OG002|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
10862706|NCT00372385|OG003|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
10862707|NCT00372385|OG000|Outcome|Telaprevir|"All Subjects from Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week and Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks."
10862708|NCT00372385|EG000|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10862709|NCT00372385|EG001|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
10862710|NCT00372385|EG002|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
10862711|NCT00372385|EG003|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
10862712|NCT00372411|BG000|Baseline|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
10862713|NCT00372411|BG001|Baseline|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
10862714|NCT00372411|BG002|Baseline|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
10862715|NCT00372411|BG003|Baseline|Total|Total of all reporting groups
10862716|NCT00372411|FG000|Participant Flow|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
10862717|NCT00372411|FG001|Participant Flow|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
10862718|NCT00372411|FG002|Participant Flow|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
10862719|NCT00372411|OG000|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
10862720|NCT00372411|OG001|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
10862721|NCT00372411|OG002|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
10862722|NCT00372411|EG000|Reported Event|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
10862723|NCT00372411|EG001|Reported Event|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
10862724|NCT00372411|EG002|Reported Event|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
10879084|NCT00455520|OG001|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
10879085|NCT00455520|EG000|Reported Event|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
10862725|NCT00372424|BG000|Baseline|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
10862726|NCT00372424|FG000|Participant Flow|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
10862727|NCT00372424|OG000|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
10862728|NCT00372424|EG000|Reported Event|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
10862729|NCT00372489|BG000|Baseline|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
10862730|NCT00372489|FG000|Participant Flow|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
10862731|NCT00372489|OG000|Outcome|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
10862732|NCT00372489|EG000|Reported Event|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
10862733|NCT00372528|BG000|Baseline|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
10862734|NCT00372528|FG000|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
10862735|NCT00372528|OG000|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
10862736|NCT00372528|EG000|Reported Event|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
10862737|NCT00372567|BG000|Baseline|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
10862738|NCT00372567|BG001|Baseline|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
10862739|NCT00372567|BG002|Baseline|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
10862740|NCT00372567|BG003|Baseline|Total|Total of all reporting groups
10862741|NCT00372567|FG000|Participant Flow|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
10862742|NCT00372567|FG001|Participant Flow|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
10862743|NCT00372567|FG002|Participant Flow|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
10862744|NCT00372567|OG000|Outcome|Sunitinib|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
10862745|NCT00372567|OG001|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
10862746|NCT00372567|OG000|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
10862747|NCT00372567|OG000|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
10862748|NCT00372567|EG000|Reported Event|All Participants Who Received Sunitinib|Participants in Phase 1 sub- study and Phase 3 study
10862749|NCT00372567|EG001|Reported Event|Imatinib|All participants who received Imatinib
10862750|NCT00372593|BG000|Baseline|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862751|NCT00372593|BG001|Baseline|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862752|NCT00372593|BG002|Baseline|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862753|NCT00372593|BG003|Baseline|Total|Total of all reporting groups
10862754|NCT00372593|FG000|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862755|NCT00372593|FG001|Participant Flow|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862756|NCT00372593|FG002|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10879086|NCT00455520|EG001|Reported Event|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
10862757|NCT00372593|OG000|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862758|NCT00372593|OG001|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862759|NCT00372593|OG002|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862760|NCT00372593|OG001|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862761|NCT00372593|EG000|Reported Event|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862762|NCT00372593|EG001|Reported Event|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10862763|NCT00372593|EG002|Reported Event|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
10879087|NCT00455533|BG000|Baseline|Ixabepilone (Randomized Population)|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
10879088|NCT00455533|BG001|Baseline|Paclitaxel (Randomized Population)|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
10879089|NCT00455533|BG002|Baseline|Total|Total of all reporting groups
10879090|NCT00455533|FG000|Participant Flow|Doxorubicin / Cyclophosphamide (AC)|60 mg/m^2 doxorubicin and 600 mg/m^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks).
10879091|NCT00455533|FG001|Participant Flow|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
10879092|NCT00455533|FG002|Participant Flow|Paclitaxel|Paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
10879093|NCT00455533|OG000|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
10862764|NCT00372619|BG000|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862765|NCT00372619|BG001|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862766|NCT00372619|BG002|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862767|NCT00372619|BG003|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862768|NCT00372619|BG004|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862769|NCT00372619|BG005|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862770|NCT00372619|BG006|Baseline|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862771|NCT00372619|BG007|Baseline|Total|Total of all reporting groups
10879094|NCT00455533|OG001|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
10879095|NCT00455533|OG000|Outcome|Randomized Participants|
10879096|NCT00455533|OG000|Outcome|Randomized Participants|Randomized Participants with non-missing pCR and biomarker expression
10879097|NCT00455533|EG000|Reported Event|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
10879098|NCT00455533|EG001|Reported Event|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
10862772|NCT00372619|FG000|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862773|NCT00372619|FG001|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862774|NCT00372619|FG002|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862775|NCT00372619|FG003|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862776|NCT00372619|FG004|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862777|NCT00372619|FG005|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862778|NCT00372619|FG006|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10879099|NCT00455650|BG000|Baseline|Schizophrenia|Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
10879100|NCT00455650|BG001|Baseline|Control|Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
10879101|NCT00455650|BG002|Baseline|Total|Total of all reporting groups
10862779|NCT00372619|OG000|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862780|NCT00372619|OG001|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862781|NCT00372619|OG002|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862782|NCT00372619|OG003|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862783|NCT00372619|OG004|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862784|NCT00372619|OG005|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862785|NCT00372619|OG006|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862786|NCT00372619|EG000|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862787|NCT00372619|EG001|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862788|NCT00372619|EG002|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862789|NCT00372619|EG003|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862790|NCT00372619|EG004|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862791|NCT00372619|EG005|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862792|NCT00372619|EG006|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
10862793|NCT00372697|BG000|Baseline|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
10862794|NCT00372697|BG001|Baseline|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
10862795|NCT00372697|BG002|Baseline|Total|Total of all reporting groups
10879102|NCT00455650|FG000|Participant Flow|Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
10862796|NCT00372697|FG000|Participant Flow|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
10862797|NCT00372697|FG001|Participant Flow|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
10862798|NCT00372697|OG000|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
10862799|NCT00372697|OG001|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
10862800|NCT00372697|EG000|Reported Event|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
10862801|NCT00372697|EG001|Reported Event|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
10862802|NCT00372775|BG000|Baseline|Sunitinib|Sunitinib 37.5 mg oral capsule daily
10862803|NCT00372775|FG000|Participant Flow|Sunitinib|Sunitinib 37.5 mg oral capsule daily
10862804|NCT00372775|OG000|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
10862805|NCT00372775|EG000|Reported Event|Sunitinib|Sunitinib 37.5 mg oral capsule daily
10862806|NCT00372905|BG000|Baseline|Bortezomib, Ibritumomab Tiuxetan, Rituximab|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862807|NCT00372905|FG000|Participant Flow|Cohort 1: 1.0mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862808|NCT00372905|FG001|Participant Flow|Cohort 2: 1.3mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862809|NCT00372905|FG002|Participant Flow|Cohort 3: 1.6mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10879103|NCT00455650|FG001|Participant Flow|Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
10862810|NCT00372905|FG003|Participant Flow|Expansion Phase: 1.3mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose (MTD), or as the determined MTD in the expansion phase.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862811|NCT00372905|OG000|Outcome|Cohort 1: 1.0mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862812|NCT00372905|OG001|Outcome|Cohort 2: 1.3mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862813|NCT00372905|OG002|Outcome|Cohort 3: 1.6mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862814|NCT00372905|OG000|Outcome|Cohort 1+ Cohort 2+ Cohort 3|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862815|NCT00372905|EG000|Reported Event|Cohort 1: 1.0mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862816|NCT00372905|EG001|Reported Event|Cohort 2: 1.3mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862817|NCT00372905|EG002|Reported Event|Cohort 3: 1.6mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862818|NCT00372905|EG003|Reported Event|Expansion Phase: 1.3mg/m2 Bortezomib|"Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15.~During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose (MTD) or at the determined MTD in the expansion phase.~Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy."
10862819|NCT00372957|BG000|Baseline|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862820|NCT00372957|BG001|Baseline|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862821|NCT00372957|BG002|Baseline|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862822|NCT00372957|BG003|Baseline|Total|Total of all reporting groups
10862823|NCT00372957|FG000|Participant Flow|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days.
10862824|NCT00372957|FG001|Participant Flow|GW823093C 15 mg|Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862825|NCT00372957|FG002|Participant Flow|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862826|NCT00372957|OG000|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862827|NCT00372957|OG001|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862828|NCT00372957|OG000|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862829|NCT00372957|OG001|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862830|NCT00372957|OG002|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862831|NCT00372957|EG000|Reported Event|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862832|NCT00372957|EG001|Reported Event|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862833|NCT00372957|EG002|Reported Event|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
10862834|NCT00372970|BG000|Baseline|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
10862835|NCT00372970|BG001|Baseline|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
10862836|NCT00372970|BG002|Baseline|Total|Total of all reporting groups
10862837|NCT00372970|FG000|Participant Flow|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
10862838|NCT00372970|FG001|Participant Flow|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
10862839|NCT00372970|OG000|Outcome|Botox|Botox injection into pylorus
10862840|NCT00372970|OG001|Outcome|Placebo|saline Injection into pylorus
10862841|NCT00372970|EG000|Reported Event|Botox|Botox injection into pylorus
10862842|NCT00372970|EG001|Reported Event|Placebo|saline Injection into pylorus
10862843|NCT00372996|BG000|Baseline|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
10862844|NCT00372996|BG001|Baseline|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
10862845|NCT00372996|BG002|Baseline|Total|Total of all reporting groups
10862846|NCT00372996|FG000|Participant Flow|CP-751,871 Plus (+) Exemestane|Participants received CP-751,871 20 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle as an intravenous (IV) infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
10862847|NCT00372996|FG001|Participant Flow|CP-751,871 + Exemestane/CP-751,871 + Fulvestrant|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
10862848|NCT00372996|FG002|Participant Flow|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
10862849|NCT00372996|FG003|Participant Flow|Exemestane/CP-751,871 + Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
10862850|NCT00372996|OG000|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
10862851|NCT00372996|OG001|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
10862852|NCT00372996|OG000|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
10862853|NCT00372996|OG001|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
10862854|NCT00372996|EG000|Reported Event|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
10862855|NCT00372996|EG001|Reported Event|CP-751,871 + Fulvestrant (After CP-751,871+Exemestane)|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
10862856|NCT00372996|EG002|Reported Event|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
10862857|NCT00372996|EG003|Reported Event|CP-751,871 + Exemestane (After Exemestane)|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
10862858|NCT00373113|BG000|Baseline|Sunitinib|37.5 mg daily, continuous dosing
10862859|NCT00373113|BG001|Baseline|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
10862860|NCT00373113|BG002|Baseline|Total|Total of all reporting groups
10862861|NCT00373113|FG000|Participant Flow|Sunitinib|37.5 milligrams (mg) daily, continuous dosing
10862862|NCT00373113|FG001|Participant Flow|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
10862863|NCT00373113|OG000|Outcome|Sunitinib|37.5 mg daily, continuous dosing
10862864|NCT00373113|OG001|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
10862865|NCT00373113|EG000|Reported Event|Sunitinib|37.5 mg daily, continuous dosing
10862866|NCT00373113|EG001|Reported Event|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
10862867|NCT00373256|BG000|Baseline|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
10862868|NCT00373256|BG001|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
10862869|NCT00373256|BG002|Baseline|Total|Total of all reporting groups
10862870|NCT00373256|FG000|Participant Flow|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 milligrams (mg) daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 milligrams per square meter (mg/m^2), at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
10862871|NCT00373256|FG001|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 milligrams per kilogram (mg/kg); infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
10862872|NCT00373256|OG000|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
10862873|NCT00373256|OG001|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
10862874|NCT00373256|EG000|Reported Event|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
10862875|NCT00373256|EG001|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
10862876|NCT00373269|BG000|Baseline|Normoglycemic|Subjects with acute ischemic stroke and normal blood glucose.
10862877|NCT00373269|BG001|Baseline|Hyperglycemic|Subjects with acute ischemic stroke and hyperglycemia.
10862878|NCT00373269|BG002|Baseline|Total|Total of all reporting groups
10862879|NCT00373269|FG000|Participant Flow|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
10862880|NCT00373269|FG001|Participant Flow|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
10862881|NCT00373269|OG000|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
10862882|NCT00373269|OG001|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
10862883|NCT00373269|EG000|Reported Event|Diabetic Subject|Subjects with acute stroke, hyperglycemia and history of diabetes.
10862884|NCT00373269|EG001|Reported Event|Normoglycemic Control|Subjects with acute stroke and normal blood glucose.
10862885|NCT00373295|BG000|Baseline|All Study Participants|Participants received placebo, baclofen (60mg) and baclofen (90mg) and smoked Marijuana (5.3% THC).
10862886|NCT00373295|FG000|Participant Flow|Baclofen 60 mg, Placebo, Baclofen 90 mg|participants received baclofen (60 mg/day) for 8 days, followed by placebo for 8 days, then baclofen (90mg/day) for 8 days.
10862887|NCT00373295|FG001|Participant Flow|Baclofen 90 mg, Placebo, Baclofen 60 mg|participants received baclofen (90mg/day) for 8 days, followed by placebo for 8 days, then baclofen (60mg/day) for 8 days.
10862888|NCT00373295|FG002|Participant Flow|Baclofen 60 mg, Baclofen 90 mg, Placebo|participants received baclofen (60mg/day) for 8 days, followed by baclofen (90mg/day) for 8 days, then placebo for 8 days.
10862889|NCT00373295|FG003|Participant Flow|Baclofen 90 mg, Baclofen 60 mg, Placebo|participants received baclofen (90mg/day) for 8 days, followed by baclofen (60mg/day) for 8 days, and then placebo for 8 days.
10862890|NCT00373295|FG004|Participant Flow|Placebo, Baclofen 90 mg, Baclofen 60 mg|participants received placebo for 8 days, followed by baclofen (90mg/day) for 8 days, then baclofen (60mg/day) for 8 days.
10862891|NCT00373295|FG005|Participant Flow|Placebo, Baclofen 60 mg, Baclofen 90 mg|participants received placebo for 8 days, followed by baclofen (60mg/day) for 8 days, then baclofen (90mg/day) for 8 days.
10862892|NCT00373295|OG000|Outcome|Baclofen 60, Marijuana|"baclofen (60 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
10862893|NCT00373295|OG001|Outcome|Placebo, Marijuana|
10862894|NCT00373295|OG002|Outcome|Baclofen 90, Marijuana|"baclofen (90 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
10862895|NCT00373295|EG000|Reported Event|Baclofen 60, Marijuana|"baclofen (60 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
10862896|NCT00373295|EG001|Reported Event|Baclofen 90, Marijuana|"baclofen (90 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
10862897|NCT00373295|EG002|Reported Event|Placebo, Marijuana|Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
10862898|NCT00373334|BG000|Baseline|Nizatidine 2.5 mg/kg b.i.d.|
10862899|NCT00373334|BG001|Baseline|Nizatidine 5.0 mg/kg b.i.d.|
10862900|NCT00373334|BG002|Baseline|Conservative Measures Only|
10862901|NCT00373334|BG003|Baseline|Total|Total of all reporting groups
10862902|NCT00373334|FG000|Participant Flow|Nizatidine 2.5 mg/kg Twice Daily|low dose nizatidine plus Conservative Measures
10862903|NCT00373334|FG001|Participant Flow|Nizatidine 5.0 mg/kg Twice Daily|high dose nizatidine plus Conservative Measures
10862904|NCT00373334|FG002|Participant Flow|Placebo|"Placebo plus Conservative Measures~Conservative Measures included:~Hypoallergenic formula thickened with dry rice cereal Avoidance of seated and supine positioning Elimination of tobacco smoke exposure"
10862905|NCT00373334|OG000|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
10862906|NCT00373334|OG001|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
10862907|NCT00373334|OG002|Outcome|Conservative Measures Only|
10862908|NCT00373334|EG000|Reported Event|Nizatidine 2.5 mg/kg b.i.d.|
10862909|NCT00373334|EG001|Reported Event|Nizatidine 5.0 mg/kg b.i.d.|
10862910|NCT00373334|EG002|Reported Event|Conservative Measures Only|
10862911|NCT00373360|BG000|Baseline|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
10862912|NCT00373360|FG000|Participant Flow|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
10862913|NCT00373360|OG000|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
10862914|NCT00373360|EG000|Reported Event|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
10862915|NCT00373386|BG000|Baseline|Growth Hormone Treatment|
10862916|NCT00373386|FG000|Participant Flow|Growth Hormone Treatment|Growth hormone 0.3 mg/kg/week given 6 days per week
10862917|NCT00373386|OG000|Outcome|Growth Hormone Treatment|"9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests)~1 with panhypopitutarism on cortisol and thyroxine replacement"
10862918|NCT00373386|OG000|Outcome|Growth Hormone|"Growth hormone treatment 0.3 mg/kg/min~growth hormone: Growth Hormone treatment"
10862919|NCT00373386|OG000|Outcome|Growth Hormone Treatment|9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies.
10862920|NCT00373386|EG000|Reported Event|Growth Hormone Treatment|9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies.
10862921|NCT00373399|BG000|Baseline|Total Sample|A total of 36 participants completed the study
10862922|NCT00373399|FG000|Participant Flow|0%, Then 1.98%, Then 3.56% THC|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
10862923|NCT00373399|FG001|Participant Flow|0%, Then 3.56%, Then 1.98% THC|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
10862924|NCT00373399|FG002|Participant Flow|1.98%, Then 0%, Then 3.56% THC|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
10862925|NCT00373399|FG003|Participant Flow|1.98%, Then 3.56%, Then 0% THC|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
10862926|NCT00373399|FG004|Participant Flow|3.56%, Then 0%, Then 1.98% THC|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
10862927|NCT00373399|FG005|Participant Flow|3.56%, Then 1.98%, Then 0% THC|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
11126361|NCT01732874|FG001|Participant Flow|Expecta 1 Gram|"Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.~Expecta 1 gram: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU."
10862928|NCT00373399|OG000|Outcome|Inactive Marijuana (0%THC)|Task performance for all 36 participants under placebo conditions.
10862929|NCT00373399|OG001|Outcome|Low Dose Marijuana (1.8% THC)|Task performance for all 36 participants under low dose marijuana conditions.
10862930|NCT00373399|OG002|Outcome|High Dose Marijuana (3.9% THC)|Task performance for all 36 participants under high dose marijuana conditions.
10862931|NCT00373399|EG000|Reported Event|Inactive Marijuana (0%THC)|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition.
10862932|NCT00373399|EG001|Reported Event|Low Dose Marijuana (1.8% THC)|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition.
10862933|NCT00373399|EG002|Reported Event|High Dose Marijuana (3.9% THC)|A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition.
10862934|NCT00373425|BG000|Baseline|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
10862935|NCT00373425|BG001|Baseline|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
10862936|NCT00373425|BG002|Baseline|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
10862937|NCT00373425|BG003|Baseline|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
10862938|NCT00373425|BG004|Baseline|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
10862939|NCT00373425|BG005|Baseline|Total|Total of all reporting groups
10862940|NCT00373425|FG000|Participant Flow|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
10862941|NCT00373425|FG001|Participant Flow|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
10862942|NCT00373425|FG002|Participant Flow|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
11348752|NCT04137783|EG002|Reported Event|no ABCA3 Mutations|"patients meet the criteria for fatal respiratory distress sydrome and undergone exome sequencing, which exclude all gene mutations involving in the respiratory disease.~no intervention: there is no intervention in this study, only observation."
10862943|NCT00373425|FG003|Participant Flow|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
10862944|NCT00373425|FG004|Participant Flow|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
10862945|NCT00373425|OG000|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
10862946|NCT00373425|OG001|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
10862947|NCT00373425|EG000|Reported Event|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
10862948|NCT00373425|EG001|Reported Event|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
10977045|NCT00943319|OG000|Outcome|Busulfan and Fludarabine|"Intravenous busulfan (Busulfan®) in combination with fludarabine~Busulfan: Daily intravenous dosing to target AVC~Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.~Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).~Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated)."
10862949|NCT00373425|EG002|Reported Event|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
10862950|NCT00373425|EG003|Reported Event|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
10862951|NCT00373425|EG004|Reported Event|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
10862952|NCT00373490|BG000|Baseline|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
10862953|NCT00373490|BG001|Baseline|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
10862954|NCT00373490|BG002|Baseline|Total|Total of all reporting groups
10862955|NCT00373490|FG000|Participant Flow|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
10862956|NCT00373490|FG001|Participant Flow|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
10862957|NCT00373490|OG000|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
10862958|NCT00373490|OG001|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
10862959|NCT00373490|EG000|Reported Event|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
10862960|NCT00373490|EG001|Reported Event|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
10862961|NCT00373529|BG000|Baseline|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
10862962|NCT00373529|FG000|Participant Flow|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
10862963|NCT00373529|OG000|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
10862964|NCT00373529|EG000|Reported Event|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
10862965|NCT00373685|BG000|Baseline|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
10862966|NCT00373685|BG001|Baseline|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
10862967|NCT00373685|BG002|Baseline|Total|Total of all reporting groups
10862968|NCT00373685|FG000|Participant Flow|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
10862969|NCT00373685|FG001|Participant Flow|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
10862970|NCT00373685|OG000|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
10862971|NCT00373685|OG001|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
10862972|NCT00373685|EG000|Reported Event|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
10862973|NCT00373685|EG001|Reported Event|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
10862974|NCT00373698|BG000|Baseline|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
10862975|NCT00373698|BG001|Baseline|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
10862976|NCT00373698|BG002|Baseline|Total|Total of all reporting groups
10862977|NCT00373698|FG000|Participant Flow|Three Component Model of Collaborative Care and Usual Care|"Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's Usual Care is at the VA provider's discretion and could include referral to mental health specialty care.specialty care."
10862978|NCT00373698|FG001|Participant Flow|Usual Care|"Participants randomized to Usual Care received care at the VA provider's discretion and could include referral to mental health specialty care."
10862979|NCT00373698|OG000|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
10862980|NCT00373698|OG001|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
10862981|NCT00373698|OG000|Outcome|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
10862982|NCT00373698|OG001|Outcome|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
10862983|NCT00373698|EG000|Reported Event|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
10862984|NCT00373698|EG001|Reported Event|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
10862985|NCT00373880|BG000|Baseline|Aripiprazole vs. Placebo|Aripiprazole + Cocaine: Participants received aripiprazole (15mg/day) or placebo (o mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
10862986|NCT00373880|FG000|Participant Flow|Aripiprazole/Placebo, Cocaine|aripiprazole (15 mg/day) or placebo (0mg/day) + smoked cocaine dose-response curve (0, 12, 25, 50 mg)
10862987|NCT00373880|OG000|Outcome|Placebo + 0mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.
10862988|NCT00373880|OG001|Outcome|Placebo + 12mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.
10862989|NCT00373880|OG002|Outcome|Placebo + 25mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.
10862990|NCT00373880|OG003|Outcome|Placebo + 50mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.
10862991|NCT00373880|OG004|Outcome|Aripiprazole + 0 mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.
10862992|NCT00373880|OG005|Outcome|Aripiprazole + 12mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.
10862993|NCT00373880|OG006|Outcome|Aripiprazole + 25mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.
10862994|NCT00373880|OG007|Outcome|Aripiprazole + 50mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
10862995|NCT00373880|EG000|Reported Event|Aripiprazole vs. Placebo|Aripiprazole + Cocaine: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
10862996|NCT00373880|EG001|Reported Event|Placebo|Placebo + Cocaine: Participants received placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
10862997|NCT00373958|BG000|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10862998|NCT00373958|BG001|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10862999|NCT00373958|BG002|Baseline|Total|Total of all reporting groups
10863000|NCT00373958|FG000|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863001|NCT00373958|FG001|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863002|NCT00373958|OG000|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863003|NCT00373958|OG001|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863004|NCT00373958|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
10863005|NCT00373958|OG001|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
10863006|NCT00373958|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
10863007|NCT00373958|OG003|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
10863008|NCT00373958|OG004|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
10863009|NCT00373958|OG005|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
10863010|NCT00373958|OG006|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863011|NCT00373958|OG007|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863012|NCT00373958|OG007|Outcome|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863013|NCT00373958|OG000|Outcome|13vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863014|NCT00373958|OG001|Outcome|7vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863015|NCT00373958|OG002|Outcome|13vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863016|NCT00373958|OG003|Outcome|7vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863017|NCT00373958|OG000|Outcome|13vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863018|NCT00373958|OG001|Outcome|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863019|NCT00373958|OG002|Outcome|13vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863020|NCT00373958|OG003|Outcome|7vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863021|NCT00373958|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
10863022|NCT00373958|EG001|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
10863023|NCT00373958|EG002|Reported Event|13vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863024|NCT00373958|EG003|Reported Event|7vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863025|NCT00373958|EG004|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863026|NCT00373958|EG005|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
10863027|NCT00373958|EG006|Reported Event|13vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863028|NCT00373958|EG007|Reported Event|7vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
10863029|NCT00374088|BG000|Baseline|Placebo|Patients not treated with N-acetylcysteine
10863030|NCT00374088|BG001|Baseline|N-acetylcysteine|Patients treated with N-acetylcysteine
10863031|NCT00374088|BG002|Baseline|Total|Total of all reporting groups
10863032|NCT00374088|FG000|Participant Flow|Placebo|Patients not treated with N-acetylcysteine
10863033|NCT00374088|FG001|Participant Flow|N-acetylcysteine|Patients treated with N-acetylcysteine
10863034|NCT00374088|OG000|Outcome|Placebo|Patients not treated with N-acetylcysteine
10863035|NCT00374088|OG001|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
10863036|NCT00374088|EG000|Reported Event|Placebo|Patients not treated with N-acetylcysteine
10863037|NCT00374088|EG001|Reported Event|N-acetylcysteine|Patients treated with N-acetylcysteine
10863038|NCT00374127|BG000|Baseline|Marijuana|marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)
10863039|NCT00374127|FG000|Participant Flow|Marijuana|marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)
10863040|NCT00374127|OG000|Outcome|Marijuana Blunt 0% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
10863041|NCT00374127|OG001|Outcome|Marijuana Blunt 1.8% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
10863042|NCT00374127|OG002|Outcome|Marijuana Blunt 3.6% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
10863043|NCT00374127|OG003|Outcome|Marijuana Cigarette 0% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
10863044|NCT00374127|OG004|Outcome|Marijuana Cigarette 1.8% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
10863045|NCT00374127|OG005|Outcome|Marijuana Cigarette 3.6% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
10863046|NCT00374127|EG000|Reported Event|Marijuana Blunt|"marijuana blunt (0%, 1.8%, or 3.6% THC)~Marijuana blunt"
10863047|NCT00374127|EG001|Reported Event|Marijuana Cigarette|"marijuana cigarette (0%, 1.8%, or 3.6% THC)~marijuana cigarette"
10863048|NCT00374140|BG000|Baseline|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
10863049|NCT00374140|FG000|Participant Flow|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
10863050|NCT00374140|OG000|Outcome|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
10863051|NCT00374140|EG000|Reported Event|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
10863052|NCT00374231|BG000|Baseline|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
10863053|NCT00374231|FG000|Participant Flow|Corticosteroid Withdrawal|Discontinue prednisone at 90 days or longer post liver transplant if rejection free previous 30 days.
10863054|NCT00374231|OG000|Outcome|Corticosteroid Withdrawa.|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
10863055|NCT00374231|OG000|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
10863056|NCT00374231|EG000|Reported Event|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
10863057|NCT00374244|BG000|Baseline|Placebo Pimozide|Half of the subjects were randomized to placebo group.
10863058|NCT00374244|BG001|Baseline|Active Pimozide|Half of the subjects are randomized to the active drug.
10863059|NCT00374244|BG002|Baseline|Total|Total of all reporting groups
10863060|NCT00374244|FG000|Participant Flow|Placebo Pimozide|Half of the subjects were randomized to placebo group.
10863061|NCT00374244|FG001|Participant Flow|Active Pimozide|Half of the subjects are randomized to the active drug.
10863062|NCT00374244|OG000|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
10863063|NCT00374244|OG001|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
10863064|NCT00374244|EG000|Reported Event|Placebo Pimozide|Half of the subjects were randomized to placebo group.
10863065|NCT00374244|EG001|Reported Event|Active Pimozide|Half of the subjects are randomized to the active drug.
10863066|NCT00374322|BG000|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
10863067|NCT00374322|BG001|Baseline|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
10863068|NCT00374322|BG002|Baseline|Total|Total of all reporting groups
10863069|NCT00374322|FG000|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
10863070|NCT00374322|FG001|Participant Flow|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
10863071|NCT00374322|OG000|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
10863072|NCT00374322|OG001|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
10863073|NCT00374322|OG001|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal
10863074|NCT00374322|EG000|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
10863075|NCT00374322|EG001|Reported Event|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
10863076|NCT00374335|BG000|Baseline|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
10863077|NCT00374335|FG000|Participant Flow|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
10863078|NCT00374335|OG000|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
10863079|NCT00374335|EG000|Reported Event|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
10863080|NCT00374452|BG000|Baseline|Guideline Link Only|"Link to JNC7 and to VA-DoD hypertension guidelines~Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines."
10863081|NCT00374452|BG001|Baseline|ATHENA-CDS-HTN|"ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.~ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care."
10863082|NCT00374452|BG002|Baseline|Total|Total of all reporting groups
10863083|NCT00374452|FG000|Participant Flow|Guideline Link Only|"Link to The Seventh Report of the Joint National Committee on Prevention Detection Evaluation and Treatment of High Blood Pressure (JNC7) and to VA-Department of Defense (DoD) hypertension guidelines~Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA-DoD and JNC7 hypertension guidelines."
10863084|NCT00374452|FG001|Participant Flow|ATHENA-CDS-HTN|"ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.~ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care."
10863085|NCT00374452|OG000|Outcome|Guideline Link Only|"Link to JNC7 and to VA-DoD hypertension guidelines~Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC hypertension guidelines."
10863086|NCT00374452|OG001|Outcome|ATHENA-CDS-HTN|"ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.~ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care."
10863087|NCT00374452|EG000|Reported Event|Guideline Link Only|"Guideline Link Only. Link to JNC7 and to VA-DoD hypertension guidelines~Guideline Link Only: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC hypertension guidelines."
10863088|NCT00374452|EG001|Reported Event|ATHENA-CDS-HTN Plus Guideline Link|"ATHENA-Clinical Decision Support (CDS)-HTN plus Guideline Link. ATHENA-CDS-HTN display on the cover sheet of electronic health record, plus link to the guidelines~ATHENA-CDS-HTN plus Guideline Link: ATHENA-CDS-HTN display provides guideline-based recommendations to clinicians at the time of patient care."
10863089|NCT00374556|BG000|Baseline|Eszopiclone|"Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
10863090|NCT00374556|BG001|Baseline|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
10863091|NCT00374556|BG002|Baseline|Total|Total of all reporting groups
10863092|NCT00374556|FG000|Participant Flow|Eszopiclone|"Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
10863093|NCT00374556|FG001|Participant Flow|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
10863094|NCT00374556|OG000|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
10863095|NCT00374556|OG001|Outcome|Eszopiclone|"Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
10863096|NCT00374556|EG000|Reported Event|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
10863097|NCT00374556|EG001|Reported Event|Eszopiclone|"Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
10863098|NCT00374803|BG000|Baseline|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
10863099|NCT00374803|BG001|Baseline|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
11126362|NCT01732874|OG000|Outcome|Expecta 200 mg|"Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.~Expecta 200 mg: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU."
10863100|NCT00374803|BG002|Baseline|Total|Total of all reporting groups
10863101|NCT00374803|FG000|Participant Flow|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
10863102|NCT00374803|FG001|Participant Flow|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
10863103|NCT00374803|OG000|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
10863104|NCT00374803|OG001|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
10863105|NCT00374803|OG000|Outcome|Mycophenolic Acid (Myfortic) Preload|"Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
10863106|NCT00374803|OG001|Outcome|Mycophenolic Acid (Myfortic) Standard|"Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).~Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
10863107|NCT00374803|EG000|Reported Event|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
10863108|NCT00374803|EG001|Reported Event|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
10863109|NCT00374842|BG000|Baseline|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863110|NCT00374842|BG001|Baseline|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863111|NCT00374842|BG002|Baseline|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863112|NCT00374842|BG003|Baseline|Total|Total of all reporting groups
10863113|NCT00374842|FG000|Participant Flow|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863114|NCT00374842|FG001|Participant Flow|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863115|NCT00374842|FG002|Participant Flow|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863116|NCT00374842|OG000|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
10863117|NCT00374842|OG001|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863118|NCT00374842|OG002|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863119|NCT00374842|OG001|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
10863120|NCT00374842|OG000|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863121|NCT00374842|EG000|Reported Event|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863122|NCT00374842|EG001|Reported Event|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10863123|NCT00374842|EG002|Reported Event|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
10863124|NCT00374868|BG000|Baseline|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
10863125|NCT00374868|FG000|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
10863126|NCT00374868|OG000|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
10863127|NCT00374868|EG000|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
10863128|NCT00374907|BG000|Baseline|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
10863129|NCT00374907|BG001|Baseline|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
10863130|NCT00374907|BG002|Baseline|Total|Total of all reporting groups
10863131|NCT00374907|FG000|Participant Flow|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
10863132|NCT00374907|FG001|Participant Flow|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
10863133|NCT00374907|OG000|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
10863134|NCT00374907|OG001|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
10863135|NCT00374907|OG000|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
10863136|NCT00374907|OG001|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
10863137|NCT00374907|EG000|Reported Event|PLACEBO/METFORMIN|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks (short term); Metformin Tablet, Oral, 500 mg titrated to 1000 mg, once daily, up to 104 weeks (long term)
10863138|NCT00374907|EG001|Reported Event|SAXAGLIPTIN 5 MG|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short term); Tablet, Oral, 5 mg, once daily, up to 104 weeks (long term)
10863139|NCT00375167|BG000|Baseline|ACT With Recovery Workbook|"Recovery Workbook (Psychoeducation training) Clients of Assertive Community Treatment randomized to condition receiving the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals~Recovery Workbook Training (psychoeducational training): The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered."
10863140|NCT00375167|BG001|Baseline|ACT as Usual|"Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based.~ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards."
10863141|NCT00375167|BG002|Baseline|Total|Total of all reporting groups
10879104|NCT00455650|FG002|Participant Flow|Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
10863142|NCT00375167|FG000|Participant Flow|ACT With Recovery Workbook|"Recovery Workbook (Psychoeducation training) Clients of Assertive Community Treatment randomized to condition receiving the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals~Recovery Workbook Training (psychoeducational training): The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered."
10863143|NCT00375167|FG001|Participant Flow|ACT as Usual|"Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based.~ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards."
10863144|NCT00375167|OG000|Outcome|ACT With Recovery Workbook|"Recovery Workbook These participants were clients of Assertive Community Treatment who were randomized to condition where in addition to usual service they received the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals~Recovery Workbook Training:The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered."
10863145|NCT00375167|OG001|Outcome|ACT as Usual|"Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based.~ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards."
10863146|NCT00375167|OG000|Outcome|ACT With Recovery Workbook|"Recovery Workbook These participants were clients of Assertive Community Treatment who were randomized to condition where in addition to usual service they received the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals~Recovery Workbook Training: The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered."
10863147|NCT00375167|OG000|Outcome|ACT With Recovery Workbook|"Recovery Workbook : These participants were clients of Assertive Community Treatment who were randomized to condition where in addition to usual service they received the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals~Recovery Workbook Training: The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action.The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was xcluded, and all practice exercises were covered."
10863148|NCT00375167|EG000|Reported Event|ACT With Recovery Workbook|"Recovery Workbook These participants were clients of Assertive Community Treatment who were randomized to condition where in addition to usual service they received the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals~Recovery Workbook Training: The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered."
10863149|NCT00375167|EG001|Reported Event|ACT as Usual|"Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based.~ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards."
10863150|NCT00375219|BG000|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863151|NCT00375219|BG001|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863152|NCT00375219|BG002|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863153|NCT00375219|BG003|Baseline|Total|Total of all reporting groups
10863154|NCT00375219|FG000|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863155|NCT00375219|FG001|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863156|NCT00375219|FG002|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863157|NCT00375219|OG000|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863158|NCT00375219|OG001|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863159|NCT00375219|OG002|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863160|NCT00375219|OG003|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
10863161|NCT00375219|EG000|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10863162|NCT00375427|BG000|Baseline|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
10863163|NCT00375427|BG001|Baseline|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
10863164|NCT00375427|BG002|Baseline|Total|Total of all reporting groups
10863165|NCT00375427|FG000|Participant Flow|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
10863166|NCT00375427|FG001|Participant Flow|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
10863167|NCT00375427|OG000|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
10863168|NCT00375427|OG001|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
10863169|NCT00375427|EG000|Reported Event|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
10863170|NCT00375427|EG001|Reported Event|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions
10863171|NCT00375492|BG000|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
10863172|NCT00375492|BG001|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
10863173|NCT00375492|BG002|Baseline|Total|Total of all reporting groups
10863174|NCT00375492|FG000|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
10863175|NCT00375492|FG001|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
10863176|NCT00375492|OG000|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
10863177|NCT00375492|OG001|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
10863178|NCT00375492|EG000|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
10863179|NCT00375492|EG001|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
10863180|NCT00375505|BG000|Baseline|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
10863181|NCT00375505|BG001|Baseline|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
10863182|NCT00375505|BG002|Baseline|Total|Total of all reporting groups
10863183|NCT00375505|FG000|Participant Flow|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
10863184|NCT00375505|FG001|Participant Flow|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
10863185|NCT00375505|OG000|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
10863186|NCT00375505|OG001|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
10863187|NCT00375505|EG000|Reported Event|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
10863188|NCT00375505|EG001|Reported Event|Zometa|Zometa
10863189|NCT00375518|BG000|Baseline|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
10863190|NCT00375518|BG001|Baseline|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
10863191|NCT00375518|BG002|Baseline|Total|Total of all reporting groups
10863192|NCT00375518|FG000|Participant Flow|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
10863193|NCT00375518|FG001|Participant Flow|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
10863194|NCT00375518|OG000|Outcome|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
10863195|NCT00375518|OG001|Outcome|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
10863196|NCT00375518|EG000|Reported Event|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
10863197|NCT00375518|EG001|Reported Event|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
10863198|NCT00375609|BG000|Baseline|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
10863199|NCT00375609|BG001|Baseline|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
10863200|NCT00375609|BG002|Baseline|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
10863201|NCT00375609|BG003|Baseline|Total|Total of all reporting groups
10863202|NCT00375609|FG000|Participant Flow|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
10863203|NCT00375609|FG001|Participant Flow|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
10863204|NCT00375609|FG002|Participant Flow|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
10863205|NCT00375609|OG000|Outcome|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
10863206|NCT00375609|OG001|Outcome|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
10863207|NCT00375609|OG002|Outcome|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
10863208|NCT00375609|EG000|Reported Event|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
10863209|NCT00375609|EG001|Reported Event|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
10863210|NCT00375609|EG002|Reported Event|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
10863211|NCT00375674|BG000|Baseline|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
10863212|NCT00375674|BG001|Baseline|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
10863213|NCT00375674|BG002|Baseline|Total|Total of all reporting groups
10863214|NCT00375674|FG000|Participant Flow|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
10863215|NCT00375674|FG001|Participant Flow|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
10863216|NCT00375674|OG000|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
10863217|NCT00375674|OG001|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
10863218|NCT00375674|EG000|Reported Event|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
10863219|NCT00375674|EG001|Reported Event|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
10863220|NCT00375713|BG000|Baseline|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
10863221|NCT00375713|BG001|Baseline|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
10863222|NCT00375713|BG002|Baseline|Total|Total of all reporting groups
10863223|NCT00375713|FG000|Participant Flow|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
10863224|NCT00375713|FG001|Participant Flow|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
10863225|NCT00375713|OG000|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
10863226|NCT00375713|OG001|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
10863227|NCT00375713|EG000|Reported Event|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
10863228|NCT00375713|EG001|Reported Event|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
10863229|NCT00375752|BG000|Baseline|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
10863230|NCT00375752|BG001|Baseline|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
10863231|NCT00375752|BG002|Baseline|Total|Total of all reporting groups
10863232|NCT00375752|FG000|Participant Flow|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
10863233|NCT00375752|FG001|Participant Flow|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
10863234|NCT00375752|OG000|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
10863235|NCT00375752|OG001|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
10863236|NCT00375752|EG000|Reported Event|Letrozole|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
10863237|NCT00375752|EG001|Reported Event|Letrozole Plus Zoledronic Acid|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
10863238|NCT00375830|BG000|Baseline|Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans|"Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI"
10863239|NCT00375830|BG001|Baseline|Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans|"Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10879105|NCT00455650|FG003|Participant Flow|Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
10863240|NCT00375830|BG002|Baseline|Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan|"Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863241|NCT00375830|BG003|Baseline|Total|Total of all reporting groups
10863242|NCT00375830|FG000|Participant Flow|Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans|"Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI"
10863243|NCT00375830|FG001|Participant Flow|Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans|"Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863244|NCT00375830|FG002|Participant Flow|Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan|"Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863245|NCT00375830|OG000|Outcome|Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans|"Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI"
10863246|NCT00375830|OG000|Outcome|Cohort 1 Pilot - 18F-NaF-CT Scan|"Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the 18F-NaF CT & 18F-FDG PET scan procedures.~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans."
10863247|NCT00375830|OG001|Outcome|Cohort 1 Pilot - 18F-FDG-PET Scan|"Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the 18F-NaF CT & 18F-FDG PET scan procedures.~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~Computed Tomography (CT) scan: Scan to detect & analyze X-rays"
10863248|NCT00375830|OG000|Outcome|Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan|"Assessment to define the utility of the combined 18F-NaF & 18F-FDG PET/CT scan.~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans."
10863249|NCT00375830|OG001|Outcome|Cohort 2 - Whole Body-MRI Scan|"Assessment to define the accuracy of the whole body-MRI scan.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863250|NCT00375830|OG000|Outcome|Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan|"Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan.~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans."
10863251|NCT00375830|OG001|Outcome|Cohort 2 - WB-MRI Scan|"Assessment to define the accuracy of the whole body MRI scan.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863252|NCT00375830|OG000|Outcome|Cohort 2 Combined 18F-NaF-CT/18F-FDG-PET Scan|"Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures.~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans."
10863253|NCT00375830|OG001|Outcome|Cohort 2 - 99mTc-MDP Bone Scintigraphy Scan|"Assessment to define the utility of the 99mTc-methyl diphosphonate (MDP) bone scintigraphy scan procedure.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures"
10863254|NCT00375830|OG000|Outcome|Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan|"Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedure;~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans."
10863255|NCT00375830|OG001|Outcome|Cohort 2 - Whole Body Magnetic Resonance Imaging (WB-MRI) Scan|"Assessment to define the accuracy of the whole body magnetic resonance imaging (WB-MRI) scan procedure.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863256|NCT00375830|OG000|Outcome|Cohort 2 Combined 18F-NaF-CT/18F-FDG-PET Scan|"Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedure.~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans."
10863257|NCT00375830|OG001|Outcome|Cohort 2 WB-MRI & 99mTc-MDP Bone Scintigraphy|"Assessment to define the accuracy of the 99mTc-methyl diphosphonate (MDP) bone scan procedure.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures"
10863258|NCT00375830|OG000|Outcome|Cohort 3 - 99mTc-methyl Diphosphonate (MDP) Bone Scan|"Assessment to define the utility of 99mTc-methyl diphosphonate (MDP) whole-body bone scintigraphy (WBBS)~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures"
10863259|NCT00375830|OG001|Outcome|Cohort 3 - 18F-NaF / 18F-FDG PET/MRI|"Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863260|NCT00375830|EG000|Reported Event|Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans|"Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI"
10863261|NCT00375830|EG001|Reported Event|Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans|"Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~Computed Tomography (CT) scan: Scan to detect & analyze X-rays~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863262|NCT00375830|EG002|Reported Event|Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan|"Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.~Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis~99mTc-methyl diphosphonate: Radiolabel for bone scan procedures~Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F~18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures~18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.~Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.~Gadofosveset: A gadolinium-based contrast agent for MRI~Gadobutrol: A gadolinium-based contrast agent for MRI"
10863263|NCT00375934|BG000|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
10863264|NCT00375934|BG001|Baseline|Placebo|Oral placebo capsule, every 6 hours
10863265|NCT00375934|BG002|Baseline|Total|Total of all reporting groups
10863266|NCT00375934|FG000|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
10863267|NCT00375934|FG001|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
10863268|NCT00375934|OG000|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
10863269|NCT00375934|OG001|Outcome|Placebo|Oral placebo capsule, every 6 hours
10863270|NCT00375934|EG000|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
10863271|NCT00375934|EG001|Reported Event|Placebo|Oral placebo capsule, every 6 hours
10863272|NCT00375973|BG000|Baseline|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
10863273|NCT00375973|BG001|Baseline|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
10863274|NCT00375973|BG002|Baseline|Total|Total of all reporting groups
10863275|NCT00375973|FG000|Participant Flow|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
10863276|NCT00375973|FG001|Participant Flow|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
10863277|NCT00375973|OG000|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
10863278|NCT00375973|OG001|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
10863279|NCT00375973|EG000|Reported Event|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
10863280|NCT00375973|EG001|Reported Event|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
10863281|NCT00375999|BG000|Baseline|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
10863282|NCT00375999|FG000|Participant Flow|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
10863283|NCT00375999|OG000|Outcome|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
10863284|NCT00375999|EG000|Reported Event|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
10863285|NCT00376168|BG000|Baseline|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
10863286|NCT00376168|BG001|Baseline|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
10863287|NCT00376168|BG002|Baseline|Total|Total of all reporting groups
10863288|NCT00376168|FG000|Participant Flow|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
10863289|NCT00376168|FG001|Participant Flow|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
10863290|NCT00376168|OG000|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
10863291|NCT00376168|OG001|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
10863292|NCT00376168|EG000|Reported Event|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
10863293|NCT00376168|EG001|Reported Event|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
10879106|NCT00455650|FG004|Participant Flow|Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
10879107|NCT00455650|FG005|Participant Flow|Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
10879108|NCT00455650|OG000|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
10879109|NCT00455650|OG001|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
10879110|NCT00455650|OG002|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
10879111|NCT00455650|OG003|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
10879112|NCT00455650|OG004|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
10879113|NCT00455650|OG005|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
10863294|NCT00376220|BG000|Baseline|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
10863295|NCT00376220|BG001|Baseline|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
10863296|NCT00376220|BG002|Baseline|Total|Total of all reporting groups
10863297|NCT00376220|FG000|Participant Flow|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take twice daily (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID [two capsules in the morning (qAM), two capsules in the evening (qHS)]. If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
10863298|NCT00376220|FG001|Participant Flow|Inactive/ Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
10863299|NCT00376220|OG000|Outcome|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
10863300|NCT00376220|OG001|Outcome|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
10863301|NCT00376220|EG000|Reported Event|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
10863302|NCT00376220|EG001|Reported Event|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
10863303|NCT00376246|BG000|Baseline|All Participants|All subjects were randomized to ezetimibe or placebo, allowed a washout period, and then crossed over to the other arm. The demographic data is presented as all participants because the only data available at this time is the aggregated data and there is no access to the primary source data due to the age of this study.
10863304|NCT00376246|FG000|Participant Flow|Ezetimibe, Then Placebo|Participants first recieved ezetimibe, after a washout period of 2 weeks, they then received a placebo.
10863305|NCT00376246|FG001|Participant Flow|Placebo, Then Ezetimibe|Participants first recieved a placebo, after a washout period of 2 weeks, they then received ezetimibe.
10863306|NCT00376246|OG000|Outcome|Placebo|Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.
10863307|NCT00376246|OG001|Outcome|Ezetimibe|Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.
10863308|NCT00376246|OG000|Outcome|Ezetimibe|All Participants received both ezetimibe and placebo in cross over design.
10863309|NCT00376246|OG001|Outcome|Placebo|All Participants received both ezetimibe and placebo in cross over design.
10977046|NCT00943319|EG000|Reported Event|Busulfan and Fludarabine|"Intravenous busulfan (Busulfan®) in combination with fludarabine~Busulfan: Daily intravenous dosing to target AVC~Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.~Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).~Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated)."
10845674|NCT00268892|EG000|Reported Event|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10845675|NCT00268892|EG001|Reported Event|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10845676|NCT00268892|EG002|Reported Event|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
10845677|NCT00268905|BG000|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
10845678|NCT00268905|BG001|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
10845679|NCT00268905|BG002|Baseline|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
10845680|NCT00268905|BG003|Baseline|Total|Total of all reporting groups
10845681|NCT00268905|FG000|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
10845682|NCT00268905|FG001|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
10845683|NCT00268905|FG002|Participant Flow|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
10845684|NCT00268905|OG000|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
10845685|NCT00268905|OG001|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
10845686|NCT00268905|OG002|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
10845687|NCT00268905|EG000|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
10845688|NCT00268905|EG001|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
10845689|NCT00268905|EG002|Reported Event|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
10845690|NCT00268983|BG000|Baseline|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
10845691|NCT00268983|BG001|Baseline|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
10845692|NCT00268983|BG002|Baseline|Total|Total of all reporting groups
10845693|NCT00268983|FG000|Participant Flow|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
10845694|NCT00268983|FG001|Participant Flow|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
10845695|NCT00268983|OG000|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
10845696|NCT00268983|OG001|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
10845697|NCT00268983|EG000|Reported Event|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
10845698|NCT00268983|EG001|Reported Event|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
10845699|NCT00268996|BG000|Baseline|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845700|NCT00268996|BG001|Baseline|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845701|NCT00268996|BG002|Baseline|Total|Total of all reporting groups
10863310|NCT00376246|EG000|Reported Event|Ezetimibe|Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.
10863311|NCT00376246|EG001|Reported Event|Placebo|Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.
10863312|NCT00376259|BG000|Baseline|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
10863313|NCT00376259|BG001|Baseline|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
10863314|NCT00376259|BG002|Baseline|Total|Total of all reporting groups
10863315|NCT00376259|FG000|Participant Flow|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
10863316|NCT00376259|FG001|Participant Flow|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
10863317|NCT00376259|OG000|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
10863318|NCT00376259|OG001|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
10863319|NCT00376259|EG000|Reported Event|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
10863320|NCT00376259|EG001|Reported Event|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
10863321|NCT00376363|BG000|Baseline|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
10863322|NCT00376363|BG001|Baseline|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
10863323|NCT00376363|BG002|Baseline|Total|Total of all reporting groups
10863324|NCT00376363|FG000|Participant Flow|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
10863325|NCT00376363|FG001|Participant Flow|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
10863326|NCT00376363|OG000|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
10863327|NCT00376363|OG001|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
10863328|NCT00376363|EG000|Reported Event|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
10863329|NCT00376363|EG001|Reported Event|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
10863330|NCT00376506|BG000|Baseline|Vibrotactile|An external vibrotactile device used for swallowing retraining
10863331|NCT00376506|BG001|Baseline|Intramuscular|An implanted neurostimulator device used for swallowing retraining
10863332|NCT00376506|BG002|Baseline|Total|Total of all reporting groups
10863333|NCT00376506|FG000|Participant Flow|Vibrotactile|An external vibrotactile device used for swallowing retraining
10863334|NCT00376506|FG001|Participant Flow|Intramuscular|An implanted neurostimulator device used for swallowing retraining
10863335|NCT00376506|OG000|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
10863336|NCT00376506|OG001|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
10863337|NCT00376506|OG001|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.retraining
10863338|NCT00376506|OG001|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
10863339|NCT00376506|OG001|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
10863340|NCT00376506|EG000|Reported Event|Vibrotactile|An external vibrotactile device used for swallowing retraining
10863341|NCT00376506|EG001|Reported Event|Intramuscular|An implanted neurostimulator device used for swallowing retraining
10863342|NCT00376532|BG000|Baseline|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
10863343|NCT00376532|BG001|Baseline|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
10863344|NCT00376532|BG002|Baseline|Total|Total of all reporting groups
10863345|NCT00376532|FG000|Participant Flow|ICD Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
10863346|NCT00376532|FG001|Participant Flow|No ICD Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
10863347|NCT00376532|OG000|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
10863348|NCT00376532|OG001|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
10863349|NCT00376532|EG000|Reported Event|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
10863350|NCT00376532|EG001|Reported Event|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
10863351|NCT00376558|BG000|Baseline|Cocaine Users|Cocaine users receiving CRA
10863352|NCT00376558|BG001|Baseline|Control Subjects|Healthy controls who undergo scans
10863353|NCT00376558|BG002|Baseline|Total|Total of all reporting groups
10863354|NCT00376558|FG000|Participant Flow|Cocaine Users|Cocaine users receiving CRA
10863355|NCT00376558|FG001|Participant Flow|Control Subjects|Healthy controls who undergo scans
10863356|NCT00376558|OG000|Outcome|Cocaine Users|Cocaine users receiving CRA
10863357|NCT00376558|OG001|Outcome|Control Subjects|Healthy controls who undergo scans
10863358|NCT00376558|OG000|Outcome|Cocaine Abuser Undergoing CM With CRA Treatment|Participants receive voucher points for each urine sample that tested negative for benzoylecgonine. Failure to submit a scheduled sample was treated as cocaine +. Voucher points have a monetary value that can be redeemed for goods/services that are approved by the therapist. Points ($0.25) were acquired on an escalating schedule that started at 10 points for the 1st cocaine-free sample, and each subsequent cocaine-free sample increased the value by 5 points. A bonus of 40 points ($10.00) for every 3 consecutive negative sample. Abstinence was confirmed by onsite urine test (Abuscreen On-Trak system, Roche Diagnostics). Missed clinic visits and urine samples that are considered + reset the points to the initial $2.50 value and the escalation schedule resume. Submission of 5 consecutive - samples after a + urine returns the voucher points to the value prior to reset. Points earned are never lost. A maximum of $997.50 is earned for submitting negative samples at all treatment visits.
10863359|NCT00376558|EG000|Reported Event|Cocaine Users|Cocaine users receiving CRA
10863360|NCT00376558|EG001|Reported Event|Control Subjects|Healthy controls who undergo scans
10863361|NCT00376597|BG000|Baseline|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
10863362|NCT00376597|BG001|Baseline|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
10863363|NCT00376597|BG002|Baseline|Total|Total of all reporting groups
10863364|NCT00376597|FG000|Participant Flow|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
10863365|NCT00376597|FG001|Participant Flow|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
10863366|NCT00376597|OG000|Outcome|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
10863367|NCT00376597|OG001|Outcome|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
10863368|NCT00376597|OG000|Outcome|All Treated Patients|This Arm consists of both Arm I and Arm II.
10863369|NCT00376597|OG000|Outcome|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
10863370|NCT00376597|EG000|Reported Event|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
10863371|NCT00376597|EG001|Reported Event|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
10863372|NCT00376675|BG000|Baseline|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
10863373|NCT00376675|BG001|Baseline|Placebo|Patients receive oral placebo daily on days 1-28.
10863374|NCT00376675|BG002|Baseline|Total|Total of all reporting groups
10863375|NCT00376675|FG000|Participant Flow|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
10863376|NCT00376675|FG001|Participant Flow|Placebo|Patients receive oral placebo daily on days 1-28.
10863377|NCT00376675|OG000|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
10863378|NCT00376675|OG001|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
10863379|NCT00376675|EG000|Reported Event|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
10863380|NCT00376675|EG001|Reported Event|Placebo|Patients receive oral placebo daily on days 1-28.
10863381|NCT00376688|BG000|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
10863382|NCT00376688|FG000|Participant Flow|Temsirolimus|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
10863383|NCT00376688|OG000|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
10863384|NCT00376688|EG000|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
10863385|NCT00376805|BG000|Baseline|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
10863386|NCT00376805|FG000|Participant Flow|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
10863387|NCT00376805|OG000|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
10863388|NCT00376805|EG000|Reported Event|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
10863389|NCT00376935|BG000|Baseline|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863390|NCT00376935|BG001|Baseline|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863391|NCT00376935|BG002|Baseline|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863392|NCT00376935|BG003|Baseline|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863393|NCT00376935|BG004|Baseline|Total|Total of all reporting groups
10863394|NCT00376935|FG000|Participant Flow|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863395|NCT00376935|FG001|Participant Flow|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863396|NCT00376935|FG002|Participant Flow|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863397|NCT00376935|FG003|Participant Flow|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863398|NCT00376935|OG000|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863399|NCT00376935|OG001|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863400|NCT00376935|OG002|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863401|NCT00376935|OG003|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863402|NCT00376935|EG000|Reported Event|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863403|NCT00376935|EG001|Reported Event|Palifermin (20 Mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863404|NCT00376935|EG002|Reported Event|Palifermin (40 Mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863405|NCT00376935|EG003|Reported Event|Palifermin (60 Mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
10863406|NCT00376948|BG000|Baseline|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
10863407|NCT00376948|FG000|Participant Flow|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
10863408|NCT00376948|OG000|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
10863409|NCT00376948|EG000|Reported Event|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
10863410|NCT00376961|BG000|Baseline|Rituximab-CHOP-Bortezomib (R-CHOP-V)|R-CHOP-V will be administered for 6 cycles (one cycle is defined as a single 21-day course of treatment).
10863411|NCT00376961|FG000|Participant Flow|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
10863412|NCT00376961|FG001|Participant Flow|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
10863413|NCT00376961|OG000|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
10863414|NCT00376961|OG000|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 dyas). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
10863415|NCT00376961|OG000|Outcome|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
10863416|NCT00376961|OG001|Outcome|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
10863417|NCT00376961|EG000|Reported Event|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle= 21 days)
10863418|NCT00376961|EG001|Reported Event|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
10863419|NCT00377156|BG000|Baseline|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
10863420|NCT00377156|BG001|Baseline|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>~> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
10863421|NCT00377156|BG002|Baseline|Total|Total of all reporting groups
10863422|NCT00377156|FG000|Participant Flow|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
10863423|NCT00377156|FG001|Participant Flow|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>~> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
10863424|NCT00377156|OG000|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
10863425|NCT00377156|OG001|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>~> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
10863426|NCT00377156|OG001|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>~>>~>~>> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
11126363|NCT01732874|OG001|Outcome|Expecta 1 Gram|"Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.~Expecta 1 gram: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU."
10863427|NCT00377156|OG001|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>>~>> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
10863428|NCT00377156|EG000|Reported Event|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
10863429|NCT00377156|EG001|Reported Event|Arm II (SRS+WBRT)|Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.
10863430|NCT00377234|BG000|Baseline|Sequence A|Ibandronate followed by risedronate
10863431|NCT00377234|BG001|Baseline|Sequence B|Risedronate followed by ibandronate
10863432|NCT00377234|BG002|Baseline|Total|Total of all reporting groups
10863433|NCT00377234|FG000|Participant Flow|Sequence A|Ibandronate followed by risedronate
10863434|NCT00377234|FG001|Participant Flow|Sequence B|Risedronate followed by ibandronate
10863435|NCT00377234|OG000|Outcome|During Sequence A|Ibandronate followed by risedronate
10863436|NCT00377234|OG001|Outcome|During Sequence B|Risendronate followed by ibandronate
10863437|NCT00377234|OG002|Outcome|Total|During period 1 + during period 2
10863438|NCT00377234|OG001|Outcome|During Sequence B|Risedronate followed by ibandronate
10863439|NCT00377234|OG000|Outcome|Ibandronate|While being treated with ibandronate
10863440|NCT00377234|OG001|Outcome|Risedronate|While being treated with risendronate
10863441|NCT00377234|OG000|Outcome|Sequence A|ibandronate followed by risedronate
10863442|NCT00377234|OG001|Outcome|Sequence B|risedronate followed by ibandronate
10863443|NCT00377234|EG000|Reported Event|Ibandronate|Ibandronate adverse events
10863444|NCT00377234|EG001|Reported Event|Risedronate|Risendronate adverse events
10845702|NCT00268996|FG000|Participant Flow|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845703|NCT00268996|FG001|Participant Flow|Darapladib 160mg EC Tablet|Eligible participants received SB-480848 (darapladib) 160 milligram (mg) enteric coated (EC) tablets once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845704|NCT00268996|OG000|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845705|NCT00268996|OG001|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845706|NCT00268996|OG001|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet one daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845707|NCT00268996|OG001|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845708|NCT00268996|EG000|Reported Event|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845709|NCT00268996|EG001|Reported Event|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
10845710|NCT00269087|BG000|Baseline|GW815SF 50/500 µg|Participants received one inhalation of GW815SF 50/500 µg (50 µg salmeterol and 500 µg fluticasone propionate) twice daily for 52 weeks. Participants also received Salbutamol sulfate aerosol as a rescue medication on an as-needed basis.
10845711|NCT00269087|FG000|Participant Flow|GW815SF 50/500 µg|Participants received one inhalation of GW815SF 50/500 micrograms (µg) (50 µg salmeterol and 500 µg fluticasone propionate) twice daily for 52 weeks. Participants also received Salbutamol sulfate aerosol as a rescue medication on an as-needed basis.
10845712|NCT00269087|OG000|Outcome|GW815SF 50/500 µg|Participants received one inhalation of GW815SF 50/500 µg (50 µg salmeterol and 500 µg fluticasone propionate) twice daily for 52 weeks. Participants also received Salbutamol sulfate aerosol as a rescue medication on an as-needed basis.
10845713|NCT00269087|EG000|Reported Event|GW815SF 50/500 µg|Participants received one inhalation of GW815SF 50/500 µg (50 µg salmeterol and 500 µg fluticasone propionate) twice daily for 52 weeks. Participants also received Salbutamol sulfate aerosol as a rescue medication on an as-needed basis.
10845714|NCT00269113|BG000|Baseline|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
10845715|NCT00269113|BG001|Baseline|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
10845716|NCT00269113|BG002|Baseline|Total|Total of all reporting groups
10845717|NCT00269113|FG000|Participant Flow|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1 and 2, chlorambucil 3 times (x) 3 mg/m^2, by mouth (PO), every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a complete remission (CR) or partial remission (PR) following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with interferon (IFN) alpha 3 x 4.5 million international units (IU) per week, subcutaneously (SC), until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
10845718|NCT00269113|FG001|Participant Flow|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
10863445|NCT00377260|BG000|Baseline|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
10863446|NCT00377260|BG001|Baseline|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
10863447|NCT00377260|BG002|Baseline|Total|Total of all reporting groups
10863448|NCT00377260|FG000|Participant Flow|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
10863449|NCT00377260|FG001|Participant Flow|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
10863450|NCT00377260|OG000|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
10863451|NCT00377260|OG001|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
10863452|NCT00377260|EG000|Reported Event|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
10863453|NCT00377260|EG001|Reported Event|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
10863454|NCT00377299|BG000|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
10863455|NCT00377299|BG001|Baseline|Placebo|
10863456|NCT00377299|BG002|Baseline|Total|Total of all reporting groups
10863457|NCT00377299|FG000|Participant Flow|Citicoline|Citicoline add-on therapy was given beginning at one tablet(500mg/day) with an increase to two tablets(1000mg/day) at week 2, three tablets(1500mg/day)at week 4 and four tablets (2000mg/day) at week 6. Patients remained on 2000mg/day throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
10863458|NCT00377299|FG001|Participant Flow|Placebo|Placebo identical in appearance to the medication was given beginning at one tablet with an increase to two tablets at week 2, three tablets at week 4 and four tablets at week 6. Patients remained on four tables throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
10863459|NCT00377299|OG000|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
10863460|NCT00377299|OG001|Outcome|Placebo|Placebo.
10863461|NCT00377299|OG001|Outcome|Placebo|Placebo matching Citicoline.
10863462|NCT00377299|EG000|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
10863463|NCT00377299|EG001|Reported Event|Placebo|
10863464|NCT00377312|BG000|Baseline|Parathyroid Hormone - 2 Picomoles/kg/hr.|Subjects initially entering the study receive study drug Parathyroid Hormone (1-34) in intravenous doses beginning at 2 picomoles/kg/hr. Doses will be slowly and safely escalated in groups of 3 subjects.
10863465|NCT00377312|BG001|Baseline|Parathyroid Hormone(1-34) - 4 Picomoles/kg/hr|Subjects received Parathyroid Hormone (1-34)intravenously at 4 picomoles/kg/hr.
10863466|NCT00377312|BG002|Baseline|Total|Total of all reporting groups
10863467|NCT00377312|FG000|Participant Flow|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
10863468|NCT00377312|FG001|Participant Flow|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
10863469|NCT00377312|OG000|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
10863470|NCT00377312|OG001|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
10863471|NCT00377312|EG000|Reported Event|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
10863472|NCT00377312|EG001|Reported Event|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
10863473|NCT00377364|BG000|Baseline|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
10863474|NCT00377364|BG001|Baseline|Placebo|Matching Placebo.
10863475|NCT00377364|BG002|Baseline|Total|Total of all reporting groups
10863476|NCT00377364|FG000|Participant Flow|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
10863477|NCT00377364|FG001|Participant Flow|Placebo|Matching Placebo.
10863478|NCT00377364|OG000|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
10863479|NCT00377364|OG001|Outcome|Placebo|Matching Placebo.
10863480|NCT00377364|OG001|Outcome|Placebo|Matching placebo.
10863481|NCT00377364|OG000|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
10863482|NCT00377364|EG000|Reported Event|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
10863483|NCT00377364|EG001|Reported Event|Placebo|Matching Placebo.
10863484|NCT00377403|BG000|Baseline|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
10863485|NCT00377403|BG001|Baseline|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
10863486|NCT00377403|BG002|Baseline|Total|Total of all reporting groups
10863487|NCT00377403|FG000|Participant Flow|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
10863488|NCT00377403|FG001|Participant Flow|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
10863489|NCT00377403|OG000|Outcome|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
10863490|NCT00377403|OG001|Outcome|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
10863491|NCT00377403|EG000|Reported Event|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
10863492|NCT00377403|EG001|Reported Event|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
10863493|NCT00377429|BG000|Baseline|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
10863494|NCT00377429|FG000|Participant Flow|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
10863495|NCT00377429|OG000|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
10863496|NCT00377429|EG000|Reported Event|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
10863497|NCT00377520|BG000|Baseline|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
10863498|NCT00377520|FG000|Participant Flow|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
10863499|NCT00377520|OG000|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
10863500|NCT00377520|EG000|Reported Event|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
10863501|NCT00377572|BG000|Baseline|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
10863502|NCT00377572|BG001|Baseline|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
10863503|NCT00377572|BG002|Baseline|Total|Total of all reporting groups
10863504|NCT00377572|FG000|Participant Flow|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
10863505|NCT00377572|FG001|Participant Flow|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
10863506|NCT00377572|OG000|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
10863507|NCT00377572|OG001|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
10863508|NCT00377572|EG000|Reported Event|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
10863509|NCT00377572|EG001|Reported Event|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
10863510|NCT00377611|BG000|Baseline|Fluarix 50-64 Years Group|Adult subjects aged between and including 50-64 years who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863511|NCT00377611|BG001|Baseline|Fluarix 65+ Years Group|Elderly subjects aged 65 and over who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863512|NCT00377611|BG002|Baseline|Total|Total of all reporting groups
10863513|NCT00377611|FG000|Participant Flow|Fluarix 50-64 Years Group|Adult subjects aged between and including 50-64 years who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863514|NCT00377611|FG001|Participant Flow|Fluarix 65+ Years Group|Elderly subjects aged 65 and over who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863515|NCT00377611|OG000|Outcome|Fluarix 50-64 Years Group|Adult subjects aged between and including 50-64 years who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863516|NCT00377611|OG001|Outcome|Fluarix 65+ Years Group|Elderly subjects aged 65 and over who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863517|NCT00377611|OG002|Outcome|Fluarix 50+ Years Group|Adult subjects aged 50 and over who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863518|NCT00377611|EG000|Reported Event|Fluarix 50-64 Years Group|Adult subjects aged between and including 50-64 years who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863519|NCT00377611|EG001|Reported Event|Fluarix 65+ Years Group|Elderly subjects aged 65 and over who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.
10863520|NCT00377637|BG000|Baseline|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
10863521|NCT00377637|BG001|Baseline|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
10863522|NCT00377637|BG002|Baseline|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
10863523|NCT00377637|BG003|Baseline|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
10863524|NCT00377637|BG004|Baseline|Total|Total of all reporting groups
10863525|NCT00377637|FG000|Participant Flow|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
10863526|NCT00377637|FG001|Participant Flow|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
10863527|NCT00377637|FG002|Participant Flow|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
10863528|NCT00377637|FG003|Participant Flow|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
10863529|NCT00377637|OG000|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
10863530|NCT00377637|OG001|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
10863531|NCT00377637|OG000|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
11223099|NCT02351037|BG002|Baseline|Ibrutinib+Azacitidine Combination Cohort|"Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).~Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles)."
10863532|NCT00377637|OG001|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
10863533|NCT00377637|OG000|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g orally twice a day + Placebo to Azathioprine orally once a day + Corticosteroid for 36 months
10863534|NCT00377637|OG001|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2 mg/kg/day orally once a day + Placebo to MMF orally twice a day + Corticosteroid for 36 months.
10863535|NCT00377637|OG000|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g twice daily (BID) along with placebo matching AZA (2.0 mg/kg/day), plus corticosteroid, until 36 months of therapy.
10863536|NCT00377637|OG001|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2.0 mg/kg/day along with placebo matching MMF (1.0 g BID), plus corticosteroid for 36 months of therapy
10863537|NCT00377637|EG000|Reported Event|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
10863538|NCT00377637|EG001|Reported Event|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
10863539|NCT00377637|EG002|Reported Event|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
10863540|NCT00377637|EG003|Reported Event|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
10863541|NCT00377676|BG000|Baseline|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
10863542|NCT00377676|BG001|Baseline|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
10863543|NCT00377676|BG002|Baseline|Total|Total of all reporting groups
11223100|NCT02351037|BG003|Baseline|Total|Total of all reporting groups
10863544|NCT00377676|FG000|Participant Flow|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
10863545|NCT00377676|FG001|Participant Flow|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
10863546|NCT00377676|OG000|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
10863547|NCT00377676|OG001|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
10863548|NCT00377676|EG000|Reported Event|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
10863549|NCT00377676|EG001|Reported Event|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
10863550|NCT00377741|BG000|Baseline|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
10863551|NCT00377741|BG001|Baseline|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
10863552|NCT00377741|BG002|Baseline|Total|Total of all reporting groups
10863553|NCT00377741|FG000|Participant Flow|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
10863554|NCT00377741|FG001|Participant Flow|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
10863555|NCT00377741|OG000|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
10863556|NCT00377741|OG001|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
10863557|NCT00377741|EG000|Reported Event|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
10863558|NCT00377741|EG001|Reported Event|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
10863559|NCT00377819|BG000|Baseline|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
10863560|NCT00377819|BG001|Baseline|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
10863561|NCT00377819|BG002|Baseline|Total|Total of all reporting groups
10863562|NCT00377819|FG000|Participant Flow|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
10863563|NCT00377819|FG001|Participant Flow|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
10863564|NCT00377819|OG000|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
10863565|NCT00377819|OG001|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
10863566|NCT00377819|EG000|Reported Event|Alendronate 70 mg QW|
10863567|NCT00377819|EG001|Reported Event|Denosumab 60 mg Q6M|
10863568|NCT00377832|BG000|Baseline|No Medication|
10863569|NCT00377832|BG001|Baseline|Acetaminophen 975 mg Once|
10863570|NCT00377832|BG002|Baseline|Total|Total of all reporting groups
10863571|NCT00377832|FG000|Participant Flow|In Labor With a Fever Will Give no Medication|
10863572|NCT00377832|FG001|Participant Flow|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
10863573|NCT00377832|OG000|Outcome|In Labor With a Fever Will Give no Medication|
10863574|NCT00377832|OG001|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
10863575|NCT00377832|OG000|Outcome|No Medication|
10863576|NCT00377832|OG001|Outcome|Acetaminophen 975 mg Once|
10863577|NCT00377832|OG000|Outcome|In Labor With a Fever Will Get no Medication|
10863578|NCT00377832|EG000|Reported Event|No Medication|In labor, fever is identified, consent and randomization occurs, then no medication is given.
10863579|NCT00377832|EG001|Reported Event|Acetaminophen 975 mg Once|In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.
10863580|NCT00377858|BG000|Baseline|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
10863581|NCT00377858|BG001|Baseline|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
10863582|NCT00377858|BG002|Baseline|Total|Total of all reporting groups
10863583|NCT00377858|FG000|Participant Flow|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
10863584|NCT00377858|FG001|Participant Flow|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
10863585|NCT00377858|OG000|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
10863586|NCT00377858|OG001|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
10863587|NCT00377858|EG000|Reported Event|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
10863588|NCT00377858|EG001|Reported Event|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
10863589|NCT00377962|BG000|Baseline|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
10863590|NCT00377962|BG001|Baseline|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
10863591|NCT00377962|BG002|Baseline|Total|Total of all reporting groups
10863592|NCT00377962|FG000|Participant Flow|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
10863593|NCT00377962|FG001|Participant Flow|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
10863594|NCT00377962|OG000|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
10863595|NCT00377962|OG001|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
10863596|NCT00377962|EG000|Reported Event|Control: 12 Month Heart|"Subgroup of Control group with heart patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
10863597|NCT00377962|EG001|Reported Event|Everolimus + CNI Reduction: 12 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
10863598|NCT00377962|EG002|Reported Event|Control: 12 Month Lung|"Subgroup of control group with lung patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
10863599|NCT00377962|EG003|Reported Event|Everolimus+CNI Reduction: 12 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
10863600|NCT00377962|EG004|Reported Event|Control: 24 Month Heart|"Subgroup of Control group with heart patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
10863601|NCT00377962|EG005|Reported Event|Everolimus + CNI Reduction: 24 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
10863602|NCT00377962|EG006|Reported Event|Control: 24 Month Lung|"Subgroup of Control group with lung patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
10863603|NCT00377962|EG007|Reported Event|Everolimus + CNI Reduction: 24 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
10863604|NCT00378014|BG000|Baseline|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
10863605|NCT00378014|BG001|Baseline|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
10863606|NCT00378014|BG002|Baseline|Total|Total of all reporting groups
10863607|NCT00378014|FG000|Participant Flow|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
10863608|NCT00378014|FG001|Participant Flow|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
10863609|NCT00378014|OG000|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
10863610|NCT00378014|OG001|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
10863611|NCT00378014|EG000|Reported Event|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
10863612|NCT00378014|EG001|Reported Event|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
10863613|NCT00378014|EG002|Reported Event|Extension Period - Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
10863614|NCT00378014|EG003|Reported Event|Extension Period - CNI|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
10863615|NCT00378079|BG000|Baseline|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
10863616|NCT00378079|BG001|Baseline|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
10863617|NCT00378079|BG002|Baseline|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
10863618|NCT00378079|BG003|Baseline|Total|Total of all reporting groups
10863619|NCT00378079|FG000|Participant Flow|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
10863620|NCT00378079|FG001|Participant Flow|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
10863621|NCT00378079|FG002|Participant Flow|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
10863622|NCT00378079|OG000|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
10863623|NCT00378079|OG001|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
10863624|NCT00378079|OG002|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
10863625|NCT00378079|EG000|Reported Event|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
10863626|NCT00378079|EG001|Reported Event|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
10863627|NCT00378079|EG002|Reported Event|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
10863628|NCT00378105|BG000|Baseline|Phase 1 Population|
10863629|NCT00378105|BG001|Baseline|Phase 2 Population|
10863630|NCT00378105|BG002|Baseline|Total|Total of all reporting groups
10863631|NCT00378105|FG000|Participant Flow|Phase 1 Population|"Four levels of dose were evaluated and a standard 3+3 dose escalation schema was used to determine the MTD and additional patients were evaluated on the MTD level.~Level 1 1 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 2 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 3 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 20 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 4 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 25 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days"
10863632|NCT00378105|FG001|Participant Flow|Phase 2 Pupulation|Each subject received the maximum planned dose of 1.3 mg/m2/IV bortezomib daily Days 1, 4, 8 and 11 followed by a 10-day rest period, 20 mg PO dexamethasone single daily oral dose Days 1, 2, 4, 5, 8, 9, 11, 12 and25 mg/PO/QD (every day)lenalidomide daily Days 1-14 followed by 7-day rest every 21 days x 4 cycles and then at 10 mg/day on the same schedule for cycles 5 - 8. Each cycle of treatment consisted of 21 days.
10863633|NCT00378105|OG000|Outcome|Phase 1 Population|
10863634|NCT00378105|OG001|Outcome|Phase II Population|
10863635|NCT00378105|OG002|Outcome|Total|
10863636|NCT00378105|OG000|Outcome|All Patients|
10863637|NCT00378105|EG000|Reported Event|All Patients|
10863638|NCT00378209|BG000|Baseline|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
10863639|NCT00378209|FG000|Participant Flow|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
10863640|NCT00378209|OG000|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
10863641|NCT00378209|OG000|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|
10863642|NCT00378209|EG000|Reported Event|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
10863643|NCT00378326|BG000|Baseline|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
10863644|NCT00378326|FG000|Participant Flow|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
10863645|NCT00378326|OG000|Outcome|Pre-treatment|White blood cell (WBC) count in CSF pre-treatment
10863646|NCT00378326|OG001|Outcome|Post-treatment|White blood cell (WBC) count in CSF post-treatment
10863647|NCT00378326|OG000|Outcome|Tacrolimus|Tacrolimus at doses of 0.15-0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
10863648|NCT00378326|EG000|Reported Event|All Patients|All patients enrolled
10863649|NCT00378352|BG000|Baseline|Epoetin Alfa|Dose escalation and efficacy phases
10863650|NCT00378352|BG001|Baseline|Placebo|Dose escalation and efficacy phases
10863651|NCT00378352|BG002|Baseline|Total|Total of all reporting groups
10863652|NCT00378352|FG000|Participant Flow|Dose Escalation 15,000 Units Epoetin Alfa|
10863653|NCT00378352|FG001|Participant Flow|Dose Escalation 30,000 Units Epoetin Alfa|
10863654|NCT00378352|FG002|Participant Flow|Dose Escalation 60,000 Units Epoetin Alfa|
10863655|NCT00378352|FG003|Participant Flow|Dose Escalation Placebo|
10863656|NCT00378352|FG004|Participant Flow|Efficacy Phase 60,000 Units Epoetin Alfa|Prospective, randomized, double-blind, placebo-controlled trial Single dose 60000 U of epoetin alfa
10863657|NCT00378352|FG005|Participant Flow|Efficacy Phase Placebo|Single dose placebo
10863658|NCT00378352|OG000|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
10863659|NCT00378352|OG001|Outcome|Placebo|Placebo for the highest dose
10863660|NCT00378352|OG000|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
10863661|NCT00378352|OG001|Outcome|Placebo|Dose escalation and efficacy phases
10863662|NCT00378352|EG000|Reported Event|Epoetin Alfa|Patients who received active study medication
10863663|NCT00378352|EG001|Reported Event|Placebo|Patients who received placebo
10863664|NCT00378508|BG000|Baseline|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863665|NCT00378508|BG001|Baseline|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863666|NCT00378508|BG002|Baseline|Total|Total of all reporting groups
10863667|NCT00378508|FG000|Participant Flow|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863668|NCT00378508|FG001|Participant Flow|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863669|NCT00378508|OG000|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863670|NCT00378508|OG001|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863671|NCT00378508|OG001|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863672|NCT00378508|EG000|Reported Event|Saline Infusions (Placebo)|The course of a saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863673|NCT00378508|EG001|Reported Event|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
10863674|NCT00378534|BG000|Baseline|T Cell Depletion Transplant Participants|Participants with hematological malignancies received a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infusion at day 90
10863675|NCT00378534|BG001|Baseline|Stem Cell Donors|An HLA 6/6 identical family member will be co-enrolled into this study as a stem cell donor. The stem cell collection aspect of this protocol is not investigational.
10863676|NCT00378534|BG002|Baseline|Total|Total of all reporting groups
10863677|NCT00378534|FG000|Participant Flow|T Cell Depletion Transplant Participants|Participants with hematological malignancies received a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infusion at day 90.
10863678|NCT00378534|FG001|Participant Flow|Stem Cell Donors|An HLA 6/6 identical family member will be co-enrolled into this study as a stem cell donor. The stem cell collection aspect of this protocol is not investigational.
10863679|NCT00378534|OG000|Outcome|T Cell Depletion Transplant Participants|Participants with hematological malignancies received a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infusion at day 90.
10863680|NCT00378534|EG000|Reported Event|T Cell Depletion Transplant Participants|Participants with hematological malignancies received a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infusion at day 90.
10863681|NCT00378534|EG001|Reported Event|Stem Cell Donors|An HLA 6/6 identical family member will be co-enrolled into this study as a stem cell donor. The stem cell collection aspect of this protocol is not investigational.
10863682|NCT00378560|BG000|Baseline|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
10863683|NCT00378560|BG001|Baseline|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
10863684|NCT00378560|BG002|Baseline|Total|Total of all reporting groups
10863685|NCT00378560|FG000|Participant Flow|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
10863686|NCT00378560|FG001|Participant Flow|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
10863687|NCT00378560|OG000|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
10863688|NCT00378560|OG001|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
10863689|NCT00378560|EG000|Reported Event|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
10863690|NCT00378560|EG001|Reported Event|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
10863691|NCT00378573|BG000|Baseline|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
10863692|NCT00378573|FG000|Participant Flow|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
10863693|NCT00378573|OG000|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
10863694|NCT00378573|EG000|Reported Event|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
10863695|NCT00378599|BG000|Baseline|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
10863696|NCT00378599|FG000|Participant Flow|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
10863697|NCT00378599|OG000|Outcome|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
10863698|NCT00378599|EG000|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
10863699|NCT00378703|BG000|Baseline|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
10863700|NCT00378703|BG001|Baseline|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
10863701|NCT00378703|BG002|Baseline|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
10863702|NCT00378703|BG003|Baseline|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
10863703|NCT00378703|BG004|Baseline|Total|Total of all reporting groups
10863704|NCT00378703|FG000|Participant Flow|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
10863705|NCT00378703|FG001|Participant Flow|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
10863706|NCT00378703|FG002|Participant Flow|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
10863707|NCT00378703|FG003|Participant Flow|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
10863708|NCT00378703|OG000|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
10863709|NCT00378703|OG001|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
10863710|NCT00378703|OG002|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
10863711|NCT00378703|OG003|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
10863712|NCT00378703|EG000|Reported Event|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
10863713|NCT00378703|EG001|Reported Event|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
10863714|NCT00378703|EG002|Reported Event|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
10863715|NCT00378703|EG003|Reported Event|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
10863716|NCT00378898|BG000|Baseline|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
10863717|NCT00378898|BG001|Baseline|EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
10863718|NCT00378898|BG002|Baseline|Total|Total of all reporting groups
10863719|NCT00378898|FG000|Participant Flow|EGD With BRAVO Capsule|"Bravo PH capsule:egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
10863720|NCT00378898|FG001|Participant Flow|EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
10863721|NCT00378898|OG000|Outcome|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
10863722|NCT00378898|OG001|Outcome|Sham Comparator: EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
10863723|NCT00378898|OG000|Outcome|EGD With Proximal BRAVO Capsule|"Subjects have a second BRAVO capsule placed 10cm proximal to prior BRAVO capsule placement. Fluoroscopy is used to confirm detachment of the monitor 7 days after investigational deployment.~BRAVO capsule~Fluoroscopy: one time xray to determine evacuation of bravo"
10863724|NCT00378898|OG001|Outcome|EGD With Sham BRAVO Capsule Placement|"Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.~sham BRAVO capsule placement"
10863725|NCT00378898|EG000|Reported Event|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement. Analysis is for participants who completed the study.~Fluoroscopy: one time xray to determine evacuation of bravo"
10863726|NCT00378898|EG001|Reported Event|EGS With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. Analysis is for participants who completed the study.
10863727|NCT00379080|BG000|Baseline|Arm 1 - Phase 0|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples"
10863728|NCT00379080|BG001|Baseline|Arm 2 - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~pharmacological study: Correlative studies"
10863729|NCT00379080|BG002|Baseline|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863730|NCT00379080|BG003|Baseline|Total|Total of all reporting groups
10863731|NCT00379080|FG000|Participant Flow|Arm 1- Phase 0|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples"
10863732|NCT00379080|FG001|Participant Flow|Arm 2 - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~pharmacological study: Correlative studies"
10863733|NCT00379080|FG002|Participant Flow|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863734|NCT00379080|OG000|Outcome|Reporting Group - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. All dose Levels~tandutinib: Given orally~pharmacological study: Correlative studies"
10863735|NCT00379080|OG000|Outcome|Arm I - Feasibility|"Participants receive oral tandutinib 500 mg twice daily for 7 days prior to surgery. Patients then undergo biopsy or surgery to remove the tumor. Tissue collected for tumor/plasma ratio.~Post surgery, within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (not necessary for feasibility)~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples~conventional surgery: Undergo surgery~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863736|NCT00379080|OG000|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863737|NCT00379080|OG001|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863738|NCT00379080|OG002|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863739|NCT00379080|OG000|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863740|NCT00379080|OG001|Outcome|Level 2 - 600mg BID (Phase 1 & Phase 2)|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863741|NCT00379080|OG001|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863742|NCT00379080|OG000|Outcome|Baseline (BL) - Overall Survival (OS)|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863743|NCT00379080|OG001|Outcome|Baseline (BL) - Progression Free Survival (PFS)|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863744|NCT00379080|OG002|Outcome|Association Between OS and Biomarker Day 2 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863745|NCT00379080|OG003|Outcome|Association Between PFS Biomarker Day 2 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863746|NCT00379080|OG004|Outcome|Association Between OS and Biomarker Day 8 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863747|NCT00379080|OG005|Outcome|Association Between PFS Biomarker Day 8 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863748|NCT00379080|OG006|Outcome|Association Between OS and Biomarker Day 10 /BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863749|NCT00379080|OG007|Outcome|Association Between PFS Biomarker Day 10 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863750|NCT00379080|OG008|Outcome|Association Between OS and Biomarker Day 28 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863751|NCT00379080|OG009|Outcome|Association Between PFS Biomarker Day 28 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
10863752|NCT00379080|EG000|Reported Event|Arm I - Feasibility|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples~conventional surgery: Undergo surgery~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863753|NCT00379080|EG001|Reported Event|Arm 2 - Dose Escalation (Phase 1)|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~the starting dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863754|NCT00379080|EG002|Reported Event|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
10863755|NCT00379145|BG000|Baseline|Trabectidin|Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10863756|NCT00379145|FG000|Participant Flow|Trabectidin|Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10863757|NCT00379145|OG000|Outcome|Trabectidin|Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10863758|NCT00379145|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10863759|NCT00379145|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10863760|NCT00379145|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10863761|NCT00379145|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10863762|NCT00379145|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10863763|NCT00379145|EG000|Reported Event|Trabectidin|Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10863764|NCT00379197|BG000|Baseline|Naltrexone|"Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG).~naltrexone hydrochloride: Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.~Positron-emission tomography (PET) / computed tomography (CT): Given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up."
10863765|NCT00379197|FG000|Participant Flow|Naltrexone|Naltrexone 50 mg taken orally once daily for 2 28-day cycles with an option to continue on Naltrexone at the discretion of the treating physician.
10863766|NCT00379197|OG000|Outcome|Naltrexone Treatment|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed as baseline level at the beginning of study and after the completion of cycle 1 and cycle 2.
10863767|NCT00379197|OG000|Outcome|Naltrexone|"Naltrexone 50 mg will be taken orally once a day every day of a 28 day treatment course (cycle 1) and continue for another identical 28 day treatment (cycle 2) . PET scan will be performed after cycle 1 and cycle 2 complete.~naltrexone: Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.~PET scan: Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up."
10863768|NCT00379197|EG000|Reported Event|Naltrexone Treatment|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up compared to the baseline level of FDG uptake.
10863769|NCT00379210|BG000|Baseline|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
10863770|NCT00379210|BG001|Baseline|Nutrition Education Group|Nutrition education group - received information about nutrition
10863771|NCT00379210|BG002|Baseline|Total|Total of all reporting groups
10863772|NCT00379210|FG000|Participant Flow|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
10863773|NCT00379210|FG001|Participant Flow|Nutrition Education Group|Nutrition education group - received information about nutrition
10863774|NCT00379210|OG000|Outcome|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
10863775|NCT00379210|OG001|Outcome|Nutrition Education Group|Nutrition education group - received information about nutrition
10863776|NCT00379210|EG000|Reported Event|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
10863777|NCT00379210|EG001|Reported Event|Nutrition Education Group|Nutrition education group - received information about nutrition
10863778|NCT00379236|BG000|Baseline|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863779|NCT00379236|BG001|Baseline|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863780|NCT00379236|BG002|Baseline|Total|Total of all reporting groups
10863781|NCT00379236|FG000|Participant Flow|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863782|NCT00379236|FG001|Participant Flow|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863783|NCT00379236|FG002|Participant Flow|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
10863784|NCT00379236|OG000|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863785|NCT00379236|OG001|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863786|NCT00379236|OG000|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863787|NCT00379236|OG001|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863788|NCT00379236|OG001|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863789|NCT00379236|OG000|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
10863790|NCT00379236|OG000|Outcome|EUFLEXXA™ Double Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863791|NCT00379236|EG000|Reported Event|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863792|NCT00379236|EG001|Reported Event|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
10863793|NCT00379236|EG002|Reported Event|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
10863794|NCT00379353|BG000|Baseline|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
10863795|NCT00379353|BG001|Baseline|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
10863796|NCT00379353|BG002|Baseline|Total|Total of all reporting groups
10863797|NCT00379353|FG000|Participant Flow|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
10863798|NCT00379353|FG001|Participant Flow|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
10863799|NCT00379353|OG000|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
10863800|NCT00379353|OG001|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
10863801|NCT00379353|OG000|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
10863802|NCT00379353|OG001|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
10863803|NCT00379353|OG002|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
10863804|NCT00379353|OG003|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
10863805|NCT00379353|OG004|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
10863806|NCT00379353|OG005|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
10863807|NCT00379353|OG000|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days
10863808|NCT00379353|OG001|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days
10863809|NCT00379353|OG002|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
10863810|NCT00379353|OG003|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
10863811|NCT00379353|EG000|Reported Event|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
10863812|NCT00379353|EG001|Reported Event|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
10863813|NCT00379574|BG000|Baseline|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
10863814|NCT00379574|FG000|Participant Flow|Bortezomib + CHOP Every 2 Weeks|"Phase I Bortezomib 1.0, 1/3, and 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5~Phase II Bortezomib 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5"
10863815|NCT00379574|OG000|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
10863816|NCT00379574|EG000|Reported Event|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
10863817|NCT00379587|BG000|Baseline|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
10863818|NCT00379587|FG000|Participant Flow|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
10863819|NCT00379587|OG000|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
10863820|NCT00379587|EG000|Reported Event|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
10863821|NCT00379639|BG000|Baseline|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
10863822|NCT00379639|BG001|Baseline|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
10863823|NCT00379639|BG002|Baseline|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
10863824|NCT00379639|BG003|Baseline|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
10863825|NCT00379639|BG004|Baseline|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
10863826|NCT00379639|BG005|Baseline|Total|Total of all reporting groups
10863827|NCT00379639|FG000|Participant Flow|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
10863828|NCT00379639|FG001|Participant Flow|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
10863829|NCT00379639|FG002|Participant Flow|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
10863830|NCT00379639|FG003|Participant Flow|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
10863831|NCT00379639|FG004|Participant Flow|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
10863832|NCT00379639|OG000|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
10863833|NCT00379639|OG001|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
10863834|NCT00379639|OG002|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
10863835|NCT00379639|OG003|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
10863836|NCT00379639|OG004|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
10863837|NCT00379639|EG000|Reported Event|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
10863838|NCT00379639|EG001|Reported Event|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
10863839|NCT00379639|EG002|Reported Event|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
10863840|NCT00379639|EG003|Reported Event|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
10863841|NCT00379639|EG004|Reported Event|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
10863842|NCT00379769|BG000|Baseline|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863843|NCT00379769|BG001|Baseline|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863844|NCT00379769|BG002|Baseline|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863845|NCT00379769|BG003|Baseline|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863846|NCT00379769|BG004|Baseline|Total|Total of all reporting groups
10863847|NCT00379769|FG000|Participant Flow|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10879114|NCT00455650|EG000|Reported Event|Schizophrenia|Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
10863848|NCT00379769|FG001|Participant Flow|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863849|NCT00379769|FG002|Participant Flow|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863850|NCT00379769|FG003|Participant Flow|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863851|NCT00379769|FG004|Participant Flow|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
10863852|NCT00379769|FG005|Participant Flow|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
10863853|NCT00379769|OG000|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863854|NCT00379769|OG001|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863855|NCT00379769|OG000|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863856|NCT00379769|OG001|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863857|NCT00379769|OG002|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863858|NCT00379769|OG003|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863859|NCT00379769|OG000|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863860|NCT00379769|OG001|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863861|NCT00379769|OG002|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863862|NCT00379769|OG001|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863863|NCT00379769|OG000|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863864|NCT00379769|OG001|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863865|NCT00379769|OG002|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863866|NCT00379769|OG003|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863867|NCT00379769|OG000|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
10863868|NCT00379769|OG000|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
10863869|NCT00379769|OG001|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
10863870|NCT00379769|OG000|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
10863871|NCT00379769|OG001|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
10863872|NCT00379769|EG000|Reported Event|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863873|NCT00379769|EG001|Reported Event|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863874|NCT00379769|EG002|Reported Event|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863875|NCT00379769|EG003|Reported Event|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
10863876|NCT00379769|EG004|Reported Event|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
10863877|NCT00379769|EG005|Reported Event|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
10863878|NCT00379795|BG000|Baseline|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
10863879|NCT00379795|BG001|Baseline|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.
10863880|NCT00379795|BG002|Baseline|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.
10863881|NCT00379795|BG003|Baseline|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.
10863882|NCT00379795|BG004|Baseline|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).
10863883|NCT00379795|BG005|Baseline|Total|Total of all reporting groups
10863884|NCT00379795|FG000|Participant Flow|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
10863885|NCT00379795|FG001|Participant Flow|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g
10863886|NCT00379795|FG002|Participant Flow|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.
10863887|NCT00379795|FG003|Participant Flow|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.
10863888|NCT00379795|FG004|Participant Flow|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).
10863889|NCT00379795|OG000|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
10863890|NCT00379795|OG001|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
10863891|NCT00379795|OG002|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
10863892|NCT00379795|OG003|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
10863893|NCT00379795|OG000|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
10863894|NCT00379795|OG001|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in that initial study or this extension study.
10863895|NCT00379795|OG002|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
10863896|NCT00379795|OG003|Outcome|Total|All enrolled subjects
10863897|NCT00379795|OG001|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in the initial study or this extension study.
10863898|NCT00379795|EG000|Reported Event|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
10863899|NCT00379795|EG001|Reported Event|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
10863900|NCT00379795|EG002|Reported Event|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g or this extension study.
10863901|NCT00379795|EG003|Reported Event|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
10863902|NCT00379808|BG000|Baseline|All Participants|Patients were randomized in a crossover design, but baseline characteristics were presented for all participants. Likewise data are not separated by order of treatment because there were no order effects
10863903|NCT00379808|FG000|Participant Flow|Placebo Then Montelukast|Patients were randomized in a crossover design to placebo or montelukast. Patients int this randomization arm received 4 weeks of placebo then 4 weeks of montelukast. There was no washout between crossover
10863904|NCT00379808|FG001|Participant Flow|Montelukast Then Placebo|Patients were randomized in a crossover design to placebo or montelukast. Patients in this arm got montelukast for 4 weeks and then placebo for 4 weeks. There was no washout period
10863905|NCT00379808|OG000|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
10863906|NCT00379808|OG001|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
10863907|NCT00379808|EG000|Reported Event|Placebo|This is all participants who received placebo, whether in first or second intervention
10863908|NCT00379808|EG001|Reported Event|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
10863909|NCT00379821|BG000|Baseline|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
10863910|NCT00379821|BG001|Baseline|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
10863911|NCT00379821|BG002|Baseline|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
10863912|NCT00379821|BG003|Baseline|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
10863913|NCT00379821|BG004|Baseline|Total|Total of all reporting groups
10863914|NCT00379821|FG000|Participant Flow|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
10863915|NCT00379821|FG001|Participant Flow|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
10863916|NCT00379821|FG002|Participant Flow|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
10863917|NCT00379821|FG003|Participant Flow|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
10863918|NCT00379821|OG000|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
10863919|NCT00379821|OG001|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
10863920|NCT00379821|OG002|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
10863921|NCT00379821|OG003|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
10863922|NCT00379821|OG000|Outcome|Chloroquine Plus Atovaquone-Proguanil|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
10863923|NCT00379821|OG001|Outcome|CQ Plus Azithromycin|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
10863924|NCT00379821|OG000|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
10863925|NCT00379821|OG001|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
10863926|NCT00379821|OG000|Outcome|Participants Who Traveled and Slept Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated yes.
10863927|NCT00379821|OG001|Outcome|Participants Who Did Not Travel and Sleep Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated no.
10863928|NCT00379821|OG000|Outcome|All Groups|Participants Receiving Any Treatment in the Study
10863929|NCT00379821|EG000|Reported Event|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
10863930|NCT00379821|EG001|Reported Event|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
10863931|NCT00379821|EG002|Reported Event|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
10863932|NCT00379821|EG003|Reported Event|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
10863933|NCT00379834|BG000|Baseline|Cosopt|Cosopt BID OU
10863934|NCT00379834|FG000|Participant Flow|Cosopt|Cosopt BID OU
10863935|NCT00379834|OG000|Outcome|Cosopt|Cosopt twice daily in both eyes
10863936|NCT00379834|EG000|Reported Event|Cosopt|Cosopt twice daily in both eyes
10863937|NCT00379899|BG000|Baseline|Cinacalcet|Cinacalcet plus low dose vitamin D
10863938|NCT00379899|BG001|Baseline|Control|Flexible vitamin D dosing
10863939|NCT00379899|BG002|Baseline|Total|Total of all reporting groups
10863940|NCT00379899|FG000|Participant Flow|Cinacalcet|Cinacalcet plus low dose vitamin D
10863941|NCT00379899|FG001|Participant Flow|Control|Flexible vitamin D dosing
10863942|NCT00379899|OG000|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
10863943|NCT00379899|OG001|Outcome|Control|Flexible vitamin D dosing
10863944|NCT00379899|EG000|Reported Event|Cinacalcet|
10863945|NCT00379899|EG001|Reported Event|Control Group|
10863946|NCT00379912|BG000|Baseline|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
10863947|NCT00379912|BG001|Baseline|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
10863948|NCT00379912|BG002|Baseline|Total|Total of all reporting groups
10863949|NCT00379912|FG000|Participant Flow|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
10863950|NCT00379912|FG001|Participant Flow|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
10863951|NCT00379912|OG000|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
10863952|NCT00379912|OG001|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
10863953|NCT00379912|OG000|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
10863954|NCT00379912|OG001|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
10863955|NCT00379912|OG000|Outcome|Investigational Arm A|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
10863956|NCT00379912|OG001|Outcome|Investigational Arm B|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
10863957|NCT00379912|OG000|Outcome|Responders|Responders
10863958|NCT00379912|OG001|Outcome|Non-Responders|Non-Responders
10863959|NCT00379912|EG000|Reported Event|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
10863960|NCT00379912|EG001|Reported Event|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
10863961|NCT00380029|BG000|Baseline|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
10879115|NCT00455650|EG001|Reported Event|Control|Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
10863962|NCT00380029|FG000|Participant Flow|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
10863963|NCT00380029|OG000|Outcome|Downstaged Tumors|transurethral resection of a bladder tumor, (TURBT) tumors resected from participants treated with neo-adjuvant erlotinib which were considered to be downstaged ( pathologic tumor stage at cystectomy <pT2 and N0)
10863964|NCT00380029|OG001|Outcome|Not-downstaged|transurethral resection of a bladder tumor, (TURBT) tumors resected from participants treated with neo-adjuvant erlotinib which were considered to be not-downstaged ( pathologic stage at cystectomy >=pT2 or node positive (N1 or N2))
10863965|NCT00380029|OG000|Outcome|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
10863966|NCT00380029|OG000|Outcome|Neoadjuvant Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
10863967|NCT00380029|OG001|Outcome|Adjuvant Erlotinib|Patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression.
10863968|NCT00380029|EG000|Reported Event|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
10863969|NCT00380068|BG000|Baseline|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
10863970|NCT00380068|FG000|Participant Flow|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
10863971|NCT00380068|OG000|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
10863972|NCT00380068|EG000|Reported Event|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
10863973|NCT00380081|BG000|Baseline|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
10863974|NCT00380081|BG001|Baseline|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
10863975|NCT00380081|BG002|Baseline|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
10863976|NCT00380081|BG003|Baseline|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
10863977|NCT00380081|BG004|Baseline|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
10863978|NCT00380081|BG005|Baseline|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
10863979|NCT00380081|BG006|Baseline|Total|Total of all reporting groups
10863980|NCT00380081|FG000|Participant Flow|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
10863981|NCT00380081|FG001|Participant Flow|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
10863982|NCT00380081|FG002|Participant Flow|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
10863983|NCT00380081|FG003|Participant Flow|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
10863984|NCT00380081|FG004|Participant Flow|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
10863985|NCT00380081|FG005|Participant Flow|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
10863986|NCT00380081|OG000|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
10863987|NCT00380081|OG001|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
10863988|NCT00380081|OG002|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
10863989|NCT00380081|EG000|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
10863990|NCT00380081|EG001|Reported Event|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
10863991|NCT00380081|EG002|Reported Event|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
10863992|NCT00380250|BG000|Baseline|Lubiprostone Study Period I|Subjects who received active drug
10863993|NCT00380250|BG001|Baseline|Placebo Study Period I|Subjects who received placebo
10863994|NCT00380250|BG002|Baseline|Total|Total of all reporting groups
10863995|NCT00380250|FG000|Participant Flow|Lubiprostone Study Period I|Subjects who received active drug
10863996|NCT00380250|FG001|Participant Flow|Placebo Study Period I|Subjects who received placebo
10863997|NCT00380250|OG000|Outcome|Lubiprostone Study Period I|Subjects who received active drug
10863998|NCT00380250|OG001|Outcome|Placebo Study Period I|Subjects who received placebo
10863999|NCT00380250|EG000|Reported Event|Lubiprostone Study Period I|8 mcg capsules twice daily (BID)
10864000|NCT00380250|EG001|Reported Event|Placebo Study Period I|Matching placebo capsules twice daily (BID)
10864001|NCT00380367|BG000|Baseline|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
10864002|NCT00380367|FG000|Participant Flow|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
10864003|NCT00380367|OG000|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
10864004|NCT00380367|EG000|Reported Event|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
10864005|NCT00380393|BG000|Baseline|GSK257049 Group|Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
10864006|NCT00380393|BG001|Baseline|Rabipur Group|Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
10864007|NCT00380393|BG002|Baseline|Total|Total of all reporting groups
10864008|NCT00380393|FG000|Participant Flow|GSK257049 Group|Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
11126364|NCT01732874|EG000|Reported Event|Expecta 200 mg|"Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.~Expecta 200 mg: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU."
10864009|NCT00380393|FG001|Participant Flow|Rabipur Group|Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
10864010|NCT00380393|OG000|Outcome|GSK257049 Group|Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
10864011|NCT00380393|OG001|Outcome|Rabipur Group|Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
10864012|NCT00380393|EG000|Reported Event|GSK257049 Group|Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
10864013|NCT00380393|EG001|Reported Event|Rabipur Group|Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
10864014|NCT00380588|BG000|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
10864015|NCT00380588|BG001|Baseline|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
10864016|NCT00380588|BG002|Baseline|Total|Total of all reporting groups
10864017|NCT00380588|FG000|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
10864018|NCT00380588|FG001|Participant Flow|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
10864019|NCT00380588|OG000|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
10864020|NCT00380588|OG001|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
10864021|NCT00380588|EG000|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
10864022|NCT00380588|EG001|Reported Event|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
10864023|NCT00380692|BG000|Baseline|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
10864024|NCT00380692|BG001|Baseline|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
10864025|NCT00380692|BG002|Baseline|Total|Total of all reporting groups
10864026|NCT00380692|FG000|Participant Flow|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
10864027|NCT00380692|FG001|Participant Flow|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
10864028|NCT00380692|OG000|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
10864029|NCT00380692|OG001|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
10864030|NCT00380692|EG000|Reported Event|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
10864031|NCT00380692|EG001|Reported Event|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
10864032|NCT00380718|BG000|Baseline|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
10864033|NCT00380718|FG000|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
11126365|NCT01732874|EG001|Reported Event|Expecta 1 Gram|"Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.~Expecta 1 gram: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU."
11126366|NCT01733056|BG000|Baseline|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
10864034|NCT00380718|OG000|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
10864035|NCT00380718|EG000|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
10864036|NCT00380744|BG000|Baseline|Part B - 0.02 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
10864037|NCT00380744|BG001|Baseline|Part A - 0.1 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
10864038|NCT00380744|BG002|Baseline|Part B - 0.15 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
10864039|NCT00380744|BG003|Baseline|Part A - 0.3 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
10864040|NCT00380744|BG004|Baseline|All Parts - 1.0 mg/kg/wk LY2189102|Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
10864041|NCT00380744|BG005|Baseline|All Parts - 2.5 mg/kg/wk LY2189102|Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
10864042|NCT00380744|BG006|Baseline|All Parts - Placebo|Participants were administered matched placebo IV, once weekly for 4 wks.
10864043|NCT00380744|BG007|Baseline|Total|Total of all reporting groups
10864044|NCT00380744|FG000|Participant Flow|Part B - 0.02 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.04 milligrams/kilogram/week (mg/kg/wk) of LY2189102, followed by 0.02 mg/kg/wk for 4 weeks (wks), intravenously (IV).
10864045|NCT00380744|FG001|Participant Flow|Part A - 0.1 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
10864046|NCT00380744|FG002|Participant Flow|Part B - 0.15 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
10864047|NCT00380744|FG003|Participant Flow|Part A - 0.3 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
10864048|NCT00380744|FG004|Participant Flow|All Parts - 1.0 mg/kg/wk LY2189102|Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
10864049|NCT00380744|FG005|Participant Flow|All Parts - 2.5 mg/kg/wk LY2189102|Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
10864050|NCT00380744|FG006|Participant Flow|All Parts - Placebo|Participants were administered matched placebo IV, once weekly for 4 wks.
11126367|NCT01733056|BG001|Baseline|Azathioprine|Patients with skin diseases taking azathioprine
10864051|NCT00380744|OG000|Outcome|0.02 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
10864052|NCT00380744|OG001|Outcome|0.1 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
10864053|NCT00380744|OG002|Outcome|0.15 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
10864054|NCT00380744|OG003|Outcome|0.3 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
10864055|NCT00380744|OG004|Outcome|1.0 mg/kg/wk LY2189102|Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
10864056|NCT00380744|OG005|Outcome|2.5 mg/kg/wk LY2189102|Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
10864057|NCT00380744|OG006|Outcome|Placebo|Participants were administered matched placebo IV, once weekly for 4 wks.
10864058|NCT00380744|OG006|Outcome|Placebo|Participants were administered matched placebo IV, once weekly for 4 wks..
10864059|NCT00380744|EG000|Reported Event|0.02 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
10864060|NCT00380744|EG001|Reported Event|0.1 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
10864061|NCT00380744|EG002|Reported Event|0.15 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
11126368|NCT01733056|BG002|Baseline|TNF Alpha Blocker|Patients with skin diseases taking TNF alpha blockers
11126369|NCT01733056|BG003|Baseline|Total|Total of all reporting groups
10864062|NCT00380744|EG003|Reported Event|0.3 mg/kg/wk LY2189102|Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
10864063|NCT00380744|EG004|Reported Event|1.0 mg/kg/wk LY2189102|Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
10864064|NCT00380744|EG005|Reported Event|2.5 mg/kg/wk LY2189102|Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
10864065|NCT00380744|EG006|Reported Event|Placebo|Participants were administered matched placebo IV, once weekly for 4 wks.
10864066|NCT00380861|BG000|Baseline|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
10864067|NCT00380861|BG001|Baseline|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
10864068|NCT00380861|BG002|Baseline|Total|Total of all reporting groups
10864069|NCT00380861|FG000|Participant Flow|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
10864070|NCT00380861|FG001|Participant Flow|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
10864071|NCT00380861|OG000|Outcome|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
10864072|NCT00380861|OG001|Outcome|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
10864073|NCT00380861|EG000|Reported Event|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
10864074|NCT00380861|EG001|Reported Event|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
10864075|NCT00380874|BG000|Baseline|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
10864076|NCT00380874|BG001|Baseline|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
10864077|NCT00380874|BG002|Baseline|Total|Total of all reporting groups
10864078|NCT00380874|FG000|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
10864079|NCT00380874|FG001|Participant Flow|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
10864080|NCT00380874|OG000|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
10864081|NCT00380874|OG001|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
10864082|NCT00380874|EG000|Reported Event|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
10864083|NCT00380874|EG001|Reported Event|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
10864084|NCT00380978|BG000|Baseline|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
11126370|NCT01733056|FG000|Participant Flow|Healthy Volunteer|
11126371|NCT01733056|FG001|Participant Flow|Azathioprine|
11126372|NCT01733056|FG002|Participant Flow|TNF Alpha Blockers|
11126373|NCT01733056|OG000|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
11126374|NCT01733056|OG001|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
11126375|NCT01733056|OG002|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
11126376|NCT01733056|EG000|Reported Event|Healthy Volunteer Pre-vaccination|Healthy volunteers who had blood drawn prior to vaccination with influenza vaccine
11126377|NCT01733056|EG001|Reported Event|Healthy Volunteer Post-vaccination|Healthy volunteers who had blood drawn after vaccination with influenza vaccine
10864085|NCT00380978|BG001|Baseline|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
10864086|NCT00380978|BG002|Baseline|Total|Total of all reporting groups
11126378|NCT01733056|EG002|Reported Event|Azathioprine Pre-vaccination|Patients with skin disease treated with azathioprine who had blood drawn prior to vaccination with influenza vaccine
10864087|NCT00380978|FG000|Participant Flow|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
10864088|NCT00380978|FG001|Participant Flow|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
10864089|NCT00380978|OG000|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
10864090|NCT00380978|OG001|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
10864091|NCT00380978|EG000|Reported Event|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
10864092|NCT00380978|EG001|Reported Event|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
10864093|NCT00381004|BG000|Baseline|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
10864094|NCT00381004|FG000|Participant Flow|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
10864095|NCT00381004|OG000|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
10864096|NCT00381004|EG000|Reported Event|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
10864097|NCT00381043|BG000|Baseline|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
10864098|NCT00381043|BG001|Baseline|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
10864099|NCT00381043|BG002|Baseline|Total|Total of all reporting groups
10864100|NCT00381043|FG000|Participant Flow|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
10864101|NCT00381043|FG001|Participant Flow|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
10864102|NCT00381043|OG000|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
10864103|NCT00381043|OG001|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
10864104|NCT00381043|EG000|Reported Event|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
10864105|NCT00381043|EG001|Reported Event|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
10864106|NCT00381095|BG000|Baseline|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
10864107|NCT00381095|BG001|Baseline|Placebo|Matching placebo capsules orally twice per day
10864108|NCT00381095|BG002|Baseline|Total|Total of all reporting groups
10864109|NCT00381095|FG000|Participant Flow|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
10864110|NCT00381095|FG001|Participant Flow|Placebo|Matching placebo capsules orally twice per day
10864111|NCT00381095|OG000|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
10864112|NCT00381095|OG001|Outcome|Placebo|Matching placebo capsules orally twice per day
10864113|NCT00381095|EG000|Reported Event|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
10864114|NCT00381095|EG001|Reported Event|Placebo|Matching placebo capsules orally twice per day
10864115|NCT00381238|BG000|Baseline|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
10864116|NCT00381238|FG000|Participant Flow|RSG XR, 8 mg|The study duration was of 50-week (Wk), which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received Rosiglitazone (RSG) extended release (XR), 4 milligram (mg) tablets once daily (od), orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
10864117|NCT00381238|OG000|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
10864118|NCT00381238|EG000|Reported Event|RSG XR, 8 MG|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
10864119|NCT00381303|BG000|Baseline|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
10864120|NCT00381303|BG001|Baseline|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
10864121|NCT00381303|BG002|Baseline|Total|Total of all reporting groups
10864122|NCT00381303|FG000|Participant Flow|Female|darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
10864123|NCT00381303|FG001|Participant Flow|Male|darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
10864124|NCT00381303|OG000|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
10864125|NCT00381303|OG001|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
10864126|NCT00381303|OG000|Outcome|Black|
10864127|NCT00381303|OG001|Outcome|Caucasian|
10864128|NCT00381303|OG002|Outcome|Hispanic|
10864129|NCT00381303|OG003|Outcome|Asian|
10864130|NCT00381303|OG004|Outcome|Other|
10864131|NCT00381303|OG000|Outcome|Female|
10864132|NCT00381303|OG001|Outcome|Male|
10864133|NCT00381303|OG002|Outcome|Black|
10864134|NCT00381303|OG003|Outcome|Caucasian|
10864135|NCT00381303|OG004|Outcome|Hispanic|
10864136|NCT00381303|OG005|Outcome|Asian|
10864137|NCT00381303|OG006|Outcome|Other|
10864138|NCT00381303|EG000|Reported Event|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
10864139|NCT00381303|EG001|Reported Event|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
10864140|NCT00381550|BG000|Baseline|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10864141|NCT00381550|FG000|Participant Flow|Triapine and Fludarabine Phosphate|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10864142|NCT00381550|OG000|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10864143|NCT00381550|EG000|Reported Event|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10864144|NCT00381563|BG000|Baseline|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
10864145|NCT00381563|BG001|Baseline|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
10864146|NCT00381563|BG002|Baseline|Total|Total of all reporting groups
10864147|NCT00381563|FG000|Participant Flow|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
10864148|NCT00381563|FG001|Participant Flow|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
10864149|NCT00381563|OG000|Outcome|Intervention Brace|"All participants who completed the trial (n=67) are re-grouped into the intervention brace group."
10864150|NCT00381563|EG000|Reported Event|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
10864151|NCT00381563|EG001|Reported Event|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
10864152|NCT00381615|BG000|Baseline|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
10864153|NCT00381615|BG001|Baseline|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
10864154|NCT00381615|BG002|Baseline|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
10864155|NCT00381615|BG003|Baseline|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
10864156|NCT00381615|BG004|Baseline|Total|Total of all reporting groups
10864157|NCT00381615|FG000|Participant Flow|rMenB|"Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months)."
10864158|NCT00381615|FG001|Participant Flow|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
10864159|NCT00381615|FG002|Participant Flow|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
10864160|NCT00381615|FG003|Participant Flow|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
10864161|NCT00381615|OG000|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
10864162|NCT00381615|OG001|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
10864163|NCT00381615|OG000|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
10864164|NCT00381615|OG001|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
10864165|NCT00381615|OG002|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
10864166|NCT00381615|OG003|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
10864167|NCT00381615|EG000|Reported Event|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
10864168|NCT00381615|EG001|Reported Event|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
10864169|NCT00381615|EG002|Reported Event|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
10864170|NCT00381615|EG003|Reported Event|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
10864171|NCT00381628|BG000|Baseline|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
11126379|NCT01733056|EG003|Reported Event|Azathioprine Post-vaccination|Patients with skin disease treated with azathioprine who had blood drawn after vaccination with influenza vaccine
10977047|NCT00943384|BG000|Baseline|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
10977048|NCT00943384|FG000|Participant Flow|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
10864172|NCT00381628|BG001|Baseline|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864173|NCT00381628|BG002|Baseline|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864174|NCT00381628|BG003|Baseline|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864175|NCT00381628|BG004|Baseline|Total|Total of all reporting groups
10864176|NCT00381628|FG000|Participant Flow|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864177|NCT00381628|FG001|Participant Flow|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864178|NCT00381628|FG002|Participant Flow|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864179|NCT00381628|FG003|Participant Flow|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864180|NCT00381628|OG000|Outcome|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864181|NCT00381628|OG001|Outcome|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864182|NCT00381628|OG002|Outcome|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864183|NCT00381628|OG003|Outcome|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864184|NCT00381628|EG000|Reported Event|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864185|NCT00381628|EG001|Reported Event|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864186|NCT00381628|EG002|Reported Event|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864187|NCT00381628|EG003|Reported Event|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
10864188|NCT00381680|BG000|Baseline|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
10864189|NCT00381680|BG001|Baseline|Arm B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
10864190|NCT00381680|BG002|Baseline|Total|Total of all reporting groups
10864191|NCT00381680|FG000|Participant Flow|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
10864192|NCT00381680|FG001|Participant Flow|Regimen B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
10864193|NCT00381680|OG000|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
10864194|NCT00381680|OG000|Outcome|All Patients|This analysis looks at all eligible patients with CC or CT genotypes as well as all eligible patients with the high-risk CEP72 genotype (TT at rs924607).
10864195|NCT00381680|OG001|Outcome|Arm B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
10864196|NCT00381680|OG000|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
10864197|NCT00381680|OG001|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
10864198|NCT00381680|OG000|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2mg)
10864199|NCT00381680|EG000|Reported Event|Regimen A: Standard Vincristine Dosing|"See detailed description.~vincristine sulfate: Given IV~prednisone: Given PO~doxorubicin hydrochloride: Given IV~pegaspargase: Given IM~cytarabine: Given IT or IV~methotrexate: Given IT or IV~dexamethasone: Given PO~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV or PO~filgrastim: Given IV or SC~asparaginase: Given IM~mercaptopurine: Given PO"
10864200|NCT00381680|EG001|Reported Event|Arm B: Randomized High Dose Vincristine Regimen|"See detailed description. Closed to accrual as of 09/2010).~vincristine sulfate: Given IV~prednisone: Given PO~doxorubicin hydrochloride: Given IV~pegaspargase: Given IM~cytarabine: Given IT or IV~methotrexate: Given IT or IV~dexamethasone: Given PO~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV or PO~filgrastim: Given IV or SC~asparaginase: Given IM~mercaptopurine: Given PO"
10864201|NCT00381693|BG000|Baseline|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
10864202|NCT00381693|FG000|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
10864203|NCT00381693|OG000|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
10864204|NCT00381693|EG000|Reported Event|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
10864205|NCT00381706|BG000|Baseline|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864206|NCT00381706|BG001|Baseline|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864207|NCT00381706|BG002|Baseline|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
10879116|NCT00455663|BG000|Baseline|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
10864208|NCT00381706|BG003|Baseline|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864209|NCT00381706|BG004|Baseline|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864210|NCT00381706|BG005|Baseline|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
10864211|NCT00381706|BG006|Baseline|Total|Total of all reporting groups
10864212|NCT00381706|FG000|Participant Flow|Arm A (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864213|NCT00381706|FG001|Participant Flow|Arm B (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864214|NCT00381706|FG002|Participant Flow|ARM C (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
10864215|NCT00381706|OG000|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864216|NCT00381706|OG001|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864217|NCT00381706|OG002|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
10864218|NCT00381706|OG000|Outcome|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864219|NCT00381706|OG001|Outcome|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864220|NCT00381706|OG002|Outcome|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
10864221|NCT00381706|EG000|Reported Event|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864222|NCT00381706|EG001|Reported Event|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864223|NCT00381706|EG002|Reported Event|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
10864224|NCT00381706|EG003|Reported Event|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864225|NCT00381706|EG004|Reported Event|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
10864226|NCT00381706|EG005|Reported Event|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
10864227|NCT00381797|BG000|Baseline|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864228|NCT00381797|BG001|Baseline|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864229|NCT00381797|BG002|Baseline|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864230|NCT00381797|BG003|Baseline|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10879117|NCT00455663|BG001|Baseline|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
10977049|NCT00943384|OG000|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
10977050|NCT00943384|EG000|Reported Event|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
10977051|NCT00943436|BG000|Baseline|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
10977052|NCT00943436|BG001|Baseline|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
10977053|NCT00943436|BG002|Baseline|Total|Total of all reporting groups
10977054|NCT00943436|FG000|Participant Flow|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
10977055|NCT00943436|FG001|Participant Flow|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
10977056|NCT00943436|OG000|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
10977057|NCT00943436|OG001|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
11223101|NCT02351037|FG000|Participant Flow|Ibrutinib Monotherapy Cohort|"Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.~Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis."
10977058|NCT00943436|EG000|Reported Event|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
10977059|NCT00943436|EG001|Reported Event|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
10977060|NCT00943488|BG000|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977061|NCT00943488|BG001|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977062|NCT00943488|BG002|Baseline|Total|Total of all reporting groups
10977063|NCT00943488|FG000|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977064|NCT00943488|FG001|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977065|NCT00943488|OG000|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977066|NCT00943488|OG001|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977067|NCT00943488|EG000|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977068|NCT00943488|EG001|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977069|NCT00943579|BG000|Baseline|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
10977070|NCT00943579|BG001|Baseline|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
10977071|NCT00943579|BG002|Baseline|Total|Total of all reporting groups
10864231|NCT00381797|BG004|Baseline|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864232|NCT00381797|BG005|Baseline|Total|Total of all reporting groups
10864233|NCT00381797|FG000|Participant Flow|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864234|NCT00381797|FG001|Participant Flow|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864235|NCT00381797|FG002|Participant Flow|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864236|NCT00381797|FG003|Participant Flow|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864237|NCT00381797|FG004|Participant Flow|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864238|NCT00381797|OG000|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10879118|NCT00455663|BG002|Baseline|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
11126380|NCT01733056|EG004|Reported Event|TNF Alpha Blocker Pre-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn prior to vaccination with influenza vaccine
11126381|NCT01733056|EG005|Reported Event|TNF Alpha Blocker Post-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn after vaccination with influenza vaccine
11223102|NCT02351037|FG001|Participant Flow|Ibrutinib + LD-AraC Combination Cohort|"Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.~Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle."
10864239|NCT00381797|OG001|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864240|NCT00381797|OG002|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864241|NCT00381797|OG003|Outcome|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864242|NCT00381797|OG000|Outcome|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864243|NCT00381797|OG000|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864244|NCT00381797|OG001|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864245|NCT00381797|OG003|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864246|NCT00381797|OG004|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10879119|NCT00455663|BG003|Baseline|Total|Total of all reporting groups
10864247|NCT00381797|OG000|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864248|NCT00381797|OG001|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864249|NCT00381797|OG002|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with Recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864250|NCT00381797|OG003|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864251|NCT00381797|OG004|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E): The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864252|NCT00381797|OG002|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with Recurrent or progressive Medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864253|NCT00381797|OG003|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent, progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10879120|NCT00455663|FG000|Participant Flow|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
10879121|NCT00455663|FG001|Participant Flow|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
10879122|NCT00455663|FG002|Participant Flow|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
11348753|NCT04136444|BG000|Baseline|Cohort A|Healthy study participants in Cohort A received a single dose of padsevonil 100 milligrams (mg) on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg twice daily (bid) from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
10864254|NCT00381797|OG001|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory Brain Stem Tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864255|NCT00381797|OG002|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864256|NCT00381797|OG002|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864257|NCT00381797|OG003|Outcome|Low Grade Glioma|Recurrent low grade glioma(Stratum E):The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864258|NCT00381797|OG000|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864259|NCT00381797|OG001|Outcome|Brain Stem Tumors|Recurrent,progressive or refractory instrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864260|NCT00381797|OG000|Outcome|Combined All Strata|High-grade Gliomas(stratum A), Medulloblastoma (stratum B), Brain Stem Tumors (stratum C), Ependymoma (stratum D), and Low Grade Glioma (stratum E) were combined for this secondary objective.
10864261|NCT00381797|OG001|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864262|NCT00381797|OG002|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864263|NCT00381797|OG003|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864264|NCT00381797|OG004|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864265|NCT00381797|OG000|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864266|NCT00381797|OG001|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864267|NCT00381797|OG000|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
10864268|NCT00381797|EG000|Reported Event|PBTC-022|Children with recurrent,progressive,or refractory malignant gliomas, diffuse/intrinsic brain stem gliomas, medulloblastomas and low grade gliomas
10864269|NCT00381810|BG000|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
10864270|NCT00381810|FG000|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
10864271|NCT00381810|OG000|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
10864272|NCT00381810|EG000|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
10864273|NCT00381849|BG000|Baseline|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
10864274|NCT00381849|BG001|Baseline|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
10864275|NCT00381849|BG002|Baseline|Total|Total of all reporting groups
10864276|NCT00381849|FG000|Participant Flow|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
10864277|NCT00381849|FG001|Participant Flow|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
10864278|NCT00381849|OG000|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
10864279|NCT00381849|OG001|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
10864280|NCT00381849|EG000|Reported Event|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
10864281|NCT00381849|EG001|Reported Event|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
10864282|NCT00381862|BG000|Baseline|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
10864283|NCT00381862|FG000|Participant Flow|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
10864284|NCT00381862|OG000|Outcome|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
10864285|NCT00381862|EG000|Reported Event|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
10864286|NCT00381888|BG000|Baseline|Patients Enrolled and Consented|This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.
10864287|NCT00381888|FG000|Participant Flow|Patients Enrolled and Consented|This number includes all patients consented and enrolled in this study.
10864288|NCT00381888|OG000|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
10864289|NCT00381888|EG000|Reported Event|All Patients Who Received at Least One Dose of Fondaparinux|This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
10864290|NCT00381940|BG000|Baseline|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
10864291|NCT00381940|FG000|Participant Flow|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
10864292|NCT00381940|OG000|Outcome|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
10864293|NCT00381940|EG000|Reported Event|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
10864294|NCT00381966|BG000|Baseline|Robotic Placement Device|"The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy.~robotic placement device: this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate."
10864295|NCT00381966|FG000|Participant Flow|Robotic Placement Device|"The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy.~robotic placement device: this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate."
10864296|NCT00381966|OG000|Outcome|Robotic Placement Device|"The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy.~robotic placement device: this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate."
10864297|NCT00381966|EG000|Reported Event|Robotic Placement Device|"The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy.~robotic placement device: this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate."
10864298|NCT00382018|BG000|Baseline|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
10864299|NCT00382018|BG001|Baseline|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
10864300|NCT00382018|BG002|Baseline|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
10864301|NCT00382018|BG003|Baseline|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
10864302|NCT00382018|BG004|Baseline|Total|Total of all reporting groups
10864303|NCT00382018|FG000|Participant Flow|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
10864304|NCT00382018|FG001|Participant Flow|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
10864305|NCT00382018|FG002|Participant Flow|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
10864306|NCT00382018|FG003|Participant Flow|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
10864307|NCT00382018|OG000|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
10864308|NCT00382018|OG001|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
10864309|NCT00382018|OG000|Outcome|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
10864310|NCT00382018|OG001|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
10864311|NCT00382018|OG002|Outcome|Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
10864312|NCT00382018|OG000|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|
10864313|NCT00382018|OG001|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
10864314|NCT00382018|OG002|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
10864315|NCT00382018|EG000|Reported Event|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|
10864316|NCT00382018|EG001|Reported Event|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
10864317|NCT00382018|EG002|Reported Event|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
10864318|NCT00382031|BG000|Baseline|Zalutumumab|Zalutumumab in combination with Best Supportive Care
10864319|NCT00382031|BG001|Baseline|Control|Best Supportive Care
10864320|NCT00382031|BG002|Baseline|Total|Total of all reporting groups
10864321|NCT00382031|FG000|Participant Flow|Zalutumumab|Zalutumumab in combination with Best Supportive Care. Patients received weekly infusions of zalutumumab. After a loading dose of 8 mg/kg the dose was reduced to 4 mg/kg and individual dose titration based on skin rash evaluation was performed.
10864322|NCT00382031|FG001|Participant Flow|Control|Best Supportive Care
10864323|NCT00382031|OG000|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
10864324|NCT00382031|OG001|Outcome|Control|Best Supportive Care
10864325|NCT00382031|EG000|Reported Event|Zalutumumab|Zalutumumab in combination with Best Supportive Care
10864326|NCT00382031|EG001|Reported Event|Control|Best Supportive Care
10864327|NCT00382070|BG000|Baseline|Placebo|Placebo
10864328|NCT00382070|BG001|Baseline|Letrozole|Letrozole
10864329|NCT00382070|BG002|Baseline|Total|Total of all reporting groups
10864330|NCT00382070|FG000|Participant Flow|Group 2 Letrozole|"Patients receive oral letrozole once daily for up to 5 years.~Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years"
10864331|NCT00382070|FG001|Participant Flow|Group 1 Placebo|"Patients receive oral placebo once daily for up to 5 years.~Placebo: Placebo tablet taken orally once daily for 5 years"
10864332|NCT00382070|OG000|Outcome|Group 2 Letrozole|"Patients receive oral letrozole once daily for up to 5 years.~Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years"
10864333|NCT00382070|OG001|Outcome|Group 1 Placebo|"Patients receive oral placebo once daily for up to 5 years.~Placebo: Placebo tablet taken orally once daily for 5 years"
10864334|NCT00382070|EG000|Reported Event|Placebo|Placebo
10864335|NCT00382070|EG001|Reported Event|Letrozole|Letrozole
10864336|NCT00382109|BG000|Baseline|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
10879123|NCT00455663|OG000|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports to assist in medication and appointment adherence
10879124|NCT00455663|OG001|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
10879125|NCT00455663|OG002|Outcome|Treatment as Usual|medication management and case management in the community mental health center
10879126|NCT00455663|OG000|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
10864337|NCT00382109|BG001|Baseline|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
10864338|NCT00382109|BG002|Baseline|Total|Total of all reporting groups
10864339|NCT00382109|FG000|Participant Flow|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
10864340|NCT00382109|FG001|Participant Flow|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
10864341|NCT00382109|OG000|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
10864342|NCT00382109|OG001|Outcome|Control|Tacro-MTX GVHD Prophylaxis
10864343|NCT00382109|OG000|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
10864344|NCT00382109|OG000|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse post transplantation (correlating development of aGVHD with relapse).
10864345|NCT00382109|OG000|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse pre transplantation (MRD)
10864346|NCT00382109|EG000|Reported Event|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
10864347|NCT00382109|EG001|Reported Event|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
10864348|NCT00382148|BG000|Baseline|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
10864349|NCT00382148|BG001|Baseline|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
10864350|NCT00382148|BG002|Baseline|Total|Total of all reporting groups
10864351|NCT00382148|FG000|Participant Flow|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
10864352|NCT00382148|FG001|Participant Flow|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
10864353|NCT00382148|OG000|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
10864354|NCT00382148|OG001|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
10864355|NCT00382148|EG000|Reported Event|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
10864356|NCT00382148|EG001|Reported Event|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
10864357|NCT00382174|BG000|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
10864358|NCT00382174|BG001|Baseline|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
10864359|NCT00382174|BG002|Baseline|Total|Total of all reporting groups
10864360|NCT00382174|FG000|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
10864361|NCT00382174|FG001|Participant Flow|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
10864362|NCT00382174|FG002|Participant Flow|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
10864363|NCT00382174|OG000|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
10864364|NCT00382174|OG001|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
10864365|NCT00382174|OG002|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
10864366|NCT00382174|EG000|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
10864367|NCT00382174|EG001|Reported Event|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
10864368|NCT00382174|EG002|Reported Event|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
10864369|NCT00382265|BG000|Baseline|Tamsulosin Group|"Tamsulosin 0.4mg PO~tamsulosin: tamsulosin 0.4mg po qd for 28 days"
10864370|NCT00382265|BG001|Baseline|Placebo Group|Placebo for 28 days
10864371|NCT00382265|BG002|Baseline|Total|Total of all reporting groups
10864372|NCT00382265|FG000|Participant Flow|Active Comparator:1|"Tamsulosin 0.4mg PO~tamsulosin: tamsulosin 0.4mg po qd for 28 days"
10864373|NCT00382265|FG001|Participant Flow|Placebo Comparator:2|"Placebo~tamsulosin: tamsulosin 0.4mg po qd for 28 days"
10864374|NCT00382265|OG000|Outcome|Tamsulosin|"Tamsulosin 0.4mg PO~tamsulosin: tamsulosin 0.4mg po qd for 28 days"
10864375|NCT00382265|OG001|Outcome|Placebo|"Placebo~tamsulosin: tamsulosin 0.4mg po qd for 28 days"
10864376|NCT00382265|OG001|Outcome|Placebo|Placebo pill po qd for 28 days
10864377|NCT00382265|OG000|Outcome|Tamsulosin|Tamsulosin 0.4mg po qd for 28 days
10864378|NCT00382265|OG001|Outcome|Placebo|Placebo Pill qd for 28 days
10864379|NCT00382265|OG001|Outcome|Control Group|Placebo pill po qd for 28 days
10864380|NCT00382265|EG000|Reported Event|Tamsulosin|Tamsulosin 0.4mg po qd for 28 days
10864381|NCT00382265|EG001|Reported Event|Placebo|Placebo Pill po qd for 28 days
11223103|NCT02351037|FG002|Participant Flow|Ibrutinib+Azacitidine Combination Cohort|"Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).~Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles)."
10879127|NCT00455663|OG001|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
10879128|NCT00455663|OG002|Outcome|Treatment as Usual|medication management and case management at a community mental health center
10879129|NCT00455663|OG002|Outcome|Treatment as Usual|Medication management and case management at a community mental health center
10879130|NCT00455663|EG000|Reported Event|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
10879131|NCT00455663|EG001|Reported Event|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
10879132|NCT00455663|EG002|Reported Event|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
10879133|NCT00455689|BG000|Baseline|Developed Hot Flashes|"Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)~Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection~Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women."
10879134|NCT00455689|BG001|Baseline|Did Not Develop Hot Flashes|"Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)~Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection~Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women."
10879135|NCT00455689|BG002|Baseline|Total|Total of all reporting groups
10879136|NCT00455689|FG000|Participant Flow|Developed Hot Flashes|"Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)~Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection~Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women."
10879137|NCT00455689|FG001|Participant Flow|Did Not Develop Hot Flashes|"Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)~Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection~Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women."
10864382|NCT00382291|BG000|Baseline|Placebo|Placebo plus cognitive behavior therapy.
10864383|NCT00382291|BG001|Baseline|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
10864384|NCT00382291|BG002|Baseline|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
10864385|NCT00382291|BG003|Baseline|Total|Total of all reporting groups
10864386|NCT00382291|FG000|Participant Flow|Placebo Plus CBT|Placebo plus cognitive behavior therapy (CBT).
10864387|NCT00382291|FG001|Participant Flow|Regular Sertraline Titration Plus CBT|Regular titration of sertraline (RegSert) plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
10864388|NCT00382291|FG002|Participant Flow|Slow Sertraline Titration Plus CBT|Slow titration of sertraline (SloSert)plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
10864389|NCT00382291|OG000|Outcome|Placebo|Placebo plus cognitive behavior therapy.
10864390|NCT00382291|OG001|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
10864391|NCT00382291|OG002|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
10864392|NCT00382291|OG001|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
10864393|NCT00382291|OG002|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
10864394|NCT00382291|EG000|Reported Event|Placebo|Placebo plus cognitive behavior therapy.
10864395|NCT00382291|EG001|Reported Event|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
10864396|NCT00382291|EG002|Reported Event|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
10864397|NCT00382408|BG000|Baseline|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
10864398|NCT00382408|BG001|Baseline|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
10864399|NCT00382408|BG002|Baseline|Total|Total of all reporting groups
10864400|NCT00382408|FG000|Participant Flow|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
10864401|NCT00382408|FG001|Participant Flow|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
10864402|NCT00382408|OG000|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
10864403|NCT00382408|OG001|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
10864404|NCT00382408|EG000|Reported Event|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
10864405|NCT00382408|EG001|Reported Event|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
10864406|NCT00382590|BG000|Baseline|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
10864407|NCT00382590|BG001|Baseline|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
10864408|NCT00382590|BG002|Baseline|Total|Total of all reporting groups
10864409|NCT00382590|FG000|Participant Flow|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
10864410|NCT00382590|FG001|Participant Flow|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
10864411|NCT00382590|OG000|Outcome|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
10864412|NCT00382590|OG001|Outcome|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
10864413|NCT00382590|EG000|Reported Event|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
10864414|NCT00382590|EG001|Reported Event|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
10864415|NCT00382720|BG000|Baseline|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
10864416|NCT00382720|BG001|Baseline|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
10864417|NCT00382720|BG002|Baseline|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
10864418|NCT00382720|BG003|Baseline|Total|Total of all reporting groups
10864419|NCT00382720|FG000|Participant Flow|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
10864420|NCT00382720|FG001|Participant Flow|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
10864421|NCT00382720|FG002|Participant Flow|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
10864422|NCT00382720|OG000|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
10864423|NCT00382720|OG001|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
10864424|NCT00382720|OG002|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
10864425|NCT00382720|EG000|Reported Event|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
10864426|NCT00382720|EG001|Reported Event|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
10864427|NCT00382720|EG002|Reported Event|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
10864428|NCT00382733|BG000|Baseline|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
10864429|NCT00382733|FG000|Participant Flow|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
10864430|NCT00382733|FG001|Participant Flow|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
10864431|NCT00382733|FG002|Participant Flow|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
10864432|NCT00382733|FG003|Participant Flow|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
10864433|NCT00382733|FG004|Participant Flow|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
10864434|NCT00382733|OG000|Outcome|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
10864435|NCT00382733|OG000|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
10864436|NCT00382733|OG001|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
10864437|NCT00382733|OG002|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
10864438|NCT00382733|OG003|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
10864439|NCT00382733|OG004|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
10864440|NCT00382733|EG000|Reported Event|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
10864441|NCT00382733|EG001|Reported Event|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
10864442|NCT00382733|EG002|Reported Event|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
10864443|NCT00382733|EG003|Reported Event|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
10864444|NCT00382733|EG004|Reported Event|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
10864445|NCT00382785|BG000|Baseline|Moderated Group|one 12-week online support group led by a professional healthcare provider
10864446|NCT00382785|BG001|Baseline|Non-facilitated (Peer-led)|12-week online support in a peer-led format
10864447|NCT00382785|BG002|Baseline|Total|Total of all reporting groups
10864448|NCT00382785|FG000|Participant Flow|Moderated Group|one 12-week online support group led by a professional healthcare provider
10864449|NCT00382785|FG001|Participant Flow|Non-facilitated (Peer-led)|12-week online support in a peer-led format
10864450|NCT00382785|OG000|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
10864451|NCT00382785|OG001|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
10864452|NCT00382785|EG000|Reported Event|Moderated|
10864453|NCT00382785|EG001|Reported Event|Peer-led|peer-led group
10864454|NCT00382824|BG000|Baseline|Coenzyme Q10 (2400mg/Day)|Patients randomized into this arm received 2400mg of coenzyme Q10 per day (300mg wafers eight times per day). Each wafer also contained 300IU of vitamin E. Patients in this group were to take this dose for 12 months.
10864455|NCT00382824|BG001|Baseline|Placebo|Patients randomized into this arm received placebo wafers. These wafers looked identical to the Coenzyme Q10 wafers. Patients took 8 placebo wafers per day.
10864456|NCT00382824|BG002|Baseline|Total|Total of all reporting groups
10864457|NCT00382824|FG000|Participant Flow|Coenzyme Q10 (2400mg/Day)|Patients randomized into this arm received 2400mg of coenzyme Q10 per day (300mg wafers eight times per day). Each wafer also contained 200IU of vitamin E for a total of 1200IU of vitamin E/day. Patients in this group were to take this dose for 12 months.
10864458|NCT00382824|FG001|Participant Flow|Placebo|Patients randomized into this arm received placebo wafers. These wafers looked identical to the Coenzyme Q10 wafers. Patients took 8 placebo wafers per day. Each wafer also contained 200IU of vitamin E. Patients received 1200IU of viatmin E/day
10864459|NCT00382824|OG000|Outcome|Coenzyme Q10 (2400mg/Day)|Patients randomized into this arm received 2400mg of coenzyme Q10 per day (300mg wafers eight times per day). Each wafer also contained 200IU of vitamin E for a total of 1200IU of vitamin E/day. Patients in this group were to take this dose for 12 months.
10864460|NCT00382824|OG001|Outcome|Placebo|Patients randomized into this arm received placebo wafers. These wafers looked identical to the Coenzyme Q10 wafers. Patients took 8 placebo wafers per day. Each wafer also contained 200IU of vitamin E. Patients received 1200IU of viatmin E/day
10864461|NCT00382824|EG000|Reported Event|Coenzyme Q10 (2400mg/Day)|Patients randomized into this arm received 2400mg of coenzyme Q10 per day (300mg wafers eight times per day). Each wafer also contained 200IU of vitamin E for a total of 1200IU of vitamin E/day. Patients in this group were to take this dose for 12 months.
10864462|NCT00382824|EG001|Reported Event|Placebo|Patients randomized into this arm received placebo wafers. These wafers looked identical to the Coenzyme Q10 wafers. Patients took 8 placebo wafers per day. Each wafer also contained 200IU of vitamin E. Patients received 1200IU of viatmin E/day
10864463|NCT00382863|BG000|Baseline|Treatment|HeartNet and Optimal Medical/Device Therapy
10864464|NCT00382863|BG001|Baseline|Control|Optimal Medical/Device Therapy alone
10864465|NCT00382863|BG002|Baseline|Total|Total of all reporting groups
10864466|NCT00382863|FG000|Participant Flow|Treatment|HeartNet and Optimal Medical/Device Therapy
10864467|NCT00382863|FG001|Participant Flow|Control|Optimal Medical/Device Therapy alone
10864468|NCT00382863|OG000|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
10864469|NCT00382863|OG001|Outcome|Control|Optimal Medical/Device Therapy alone
10864470|NCT00382863|EG000|Reported Event|Treatment|HeartNet and Optimal Medical/Device Therapy
10864471|NCT00382863|EG001|Reported Event|Control|Optimal Medical/Device Therapy alone
10864472|NCT00382928|BG000|Baseline|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
10864473|NCT00382928|BG001|Baseline|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
10864474|NCT00382928|BG002|Baseline|Total|Total of all reporting groups
10864475|NCT00382928|FG000|Participant Flow|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention
10864476|NCT00382928|FG001|Participant Flow|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
10864477|NCT00382928|OG000|Outcome|Experimental: AECD Monitoring + Stand of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
10864478|NCT00382928|OG001|Outcome|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
10864479|NCT00382928|OG000|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
10864480|NCT00382928|OG001|Outcome|Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
10864481|NCT00382928|OG000|Outcome|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
10864482|NCT00382928|OG001|Outcome|No Intervention: Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
10864483|NCT00382928|OG001|Outcome|Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
10864484|NCT00382928|EG000|Reported Event|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
10864485|NCT00382928|EG001|Reported Event|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
10864486|NCT00382967|BG000|Baseline|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
10864487|NCT00382967|BG001|Baseline|Control Arm|No (Injection) Intervention
10864488|NCT00382967|BG002|Baseline|Total|Total of all reporting groups
10864489|NCT00382967|FG000|Participant Flow|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
10864490|NCT00382967|FG001|Participant Flow|Control Arm|No (Injection) Intervention
10864491|NCT00382967|OG000|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
10864492|NCT00382967|OG001|Outcome|Control Arm|No (Injection) Intervention
10864493|NCT00382967|EG000|Reported Event|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
10864494|NCT00382967|EG001|Reported Event|Control Arm|No (Injection) Intervention
10864495|NCT00382993|BG000|Baseline|Safety Population|Safety Population - Participants who were randomized and who treated at least 1 migraine attack with investigational product.
10864496|NCT00382993|FG000|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
10864497|NCT00382993|FG001|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
10864498|NCT00382993|OG000|Outcome|Placebo|
10864499|NCT00382993|OG001|Outcome|Sumatriptan/Naproxen Sodium|
10864500|NCT00382993|EG000|Reported Event|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
10864501|NCT00382993|EG001|Reported Event|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
10864502|NCT00383019|BG000|Baseline|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
10864503|NCT00383019|BG001|Baseline|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
10864504|NCT00383019|BG002|Baseline|Total|Total of all reporting groups
10864505|NCT00383019|FG000|Participant Flow|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
10864506|NCT00383019|FG001|Participant Flow|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
10864507|NCT00383019|OG000|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
10864508|NCT00383019|OG001|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
10864509|NCT00383019|EG000|Reported Event|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
10864510|NCT00383019|EG001|Reported Event|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
10864511|NCT00383071|BG000|Baseline|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
10864512|NCT00383071|BG001|Baseline|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
10864513|NCT00383071|BG002|Baseline|180 mcg Cohort 4|180 mcg IM every 4 weeks for 2 vaccinations
10864514|NCT00383071|BG003|Baseline|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
10864515|NCT00383071|BG004|Baseline|Total|Total of all reporting groups
10864516|NCT00383071|FG000|Participant Flow|Cohort 2: 120 mcg|120 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
10864517|NCT00383071|FG001|Participant Flow|Cohort 3: 180 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
10864518|NCT00383071|FG002|Participant Flow|Cohort 4: 180 mcg|120 mcg every 28 days x 2 doses. Subjects randomized to receive vaccination in arm or buttock.
10864519|NCT00383071|FG003|Participant Flow|Cohort 1: 90 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
10864520|NCT00383071|OG000|Outcome|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
10864521|NCT00383071|OG001|Outcome|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
10864522|NCT00383071|OG002|Outcome|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
10864523|NCT00383071|OG003|Outcome|180 mcg Cohort 4|120 mcg IM every 4 weeks for 2 vaccinations
10864524|NCT00383071|EG000|Reported Event|120 mcg|120 mcg every 28 days x 4 doses
10864525|NCT00383071|EG001|Reported Event|180 mcg|180 mcg every 28 days x 4 doses
10864526|NCT00383071|EG002|Reported Event|180 mcg Cohort 4|180 mcg every 28 days x 2 doses
10864527|NCT00383071|EG003|Reported Event|90 mcg|90 mcg every 28 days x 4 doses
10864528|NCT00383084|BG000|Baseline|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
10864529|NCT00383084|BG001|Baseline|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
10864530|NCT00383084|BG002|Baseline|Total|Total of all reporting groups
10864531|NCT00383084|FG000|Participant Flow|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
10864532|NCT00383084|FG001|Participant Flow|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
10864533|NCT00383084|OG000|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
10864534|NCT00383084|OG001|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
10864535|NCT00383084|EG000|Reported Event|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
10864536|NCT00383084|EG001|Reported Event|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
10864537|NCT00383110|BG000|Baseline|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
10864538|NCT00383110|BG001|Baseline|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
10864539|NCT00383110|BG002|Baseline|Total|Total of all reporting groups
10864540|NCT00383110|FG000|Participant Flow|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
10864541|NCT00383110|FG001|Participant Flow|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
10864542|NCT00383110|OG000|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
10864543|NCT00383110|OG001|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
10864544|NCT00383110|OG001|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
10864545|NCT00383110|EG000|Reported Event|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
10864546|NCT00383110|EG001|Reported Event|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
10864547|NCT00383123|BG000|Baseline|Fluarix Group|"Subjects in this group received Fluarix and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
10864548|NCT00383123|BG001|Baseline|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
10864549|NCT00383123|BG002|Baseline|Total|Total of all reporting groups
10864550|NCT00383123|FG000|Participant Flow|Fluarix Group|"Subjects in this group received Fluarix and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
10864551|NCT00383123|FG001|Participant Flow|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
10864552|NCT00383123|OG000|Outcome|Fluarix Group|"Subjects in this group received Fluarix and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
10864553|NCT00383123|OG001|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
10864554|NCT00383123|EG000|Reported Event|Fluarix Group|"Subjects in this group received Fluarix and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
10864555|NCT00383123|EG001|Reported Event|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
10864556|NCT00383149|BG000|Baseline|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
10864557|NCT00383149|FG000|Participant Flow|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
10864558|NCT00383149|OG000|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
10864559|NCT00383149|OG000|Outcome|Ixabepilone|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks.
10864560|NCT00383149|OG001|Outcome|Cetuximab|All participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
10864561|NCT00383149|EG000|Reported Event|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
10864562|NCT00383162|BG000|Baseline|Safety Population|Safety Population - Participants who were randomized and who treated at least 1 migraine attack with investigational product.
10864563|NCT00383162|FG000|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
10864564|NCT00383162|FG001|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
10864565|NCT00383162|OG000|Outcome|Placebo|
10864566|NCT00383162|OG001|Outcome|Sumatriptan-Naproxen Sodium|
10864567|NCT00383162|EG000|Reported Event|Placebo|Subjects who were randomized to take Placebo during Migraine period 1, then a one week wash-out period without any drugs, and then given Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 2.
10864568|NCT00383162|EG001|Reported Event|Sumatriptan-Naproxen Sodium|Subjects who were randomized to take Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 1, then a one week wash-out period without any drugs, and then given Placebo during Migraine period 2.
10864569|NCT00383188|BG000|Baseline|PH-797804, 0.5 mg|Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864570|NCT00383188|BG001|Baseline|PH79804, 3 mg|Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864571|NCT00383188|BG002|Baseline|PH-797804, 6 mg|Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864572|NCT00383188|BG003|Baseline|PH-797804, 10 mg|Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864573|NCT00383188|BG004|Baseline|Placebo|Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864574|NCT00383188|BG005|Baseline|Total|Total of all reporting groups
10864575|NCT00383188|FG000|Participant Flow|PH-797804, 0.5 mg|Participants received PH-797804, 0.5 milligram (mg) capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864576|NCT00383188|FG001|Participant Flow|PH79804, 3 mg|Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864577|NCT00383188|FG002|Participant Flow|PH-797804, 6 mg|Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864578|NCT00383188|FG003|Participant Flow|PH-797804, 10 mg|Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864579|NCT00383188|FG004|Participant Flow|Placebo|Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864580|NCT00383188|OG000|Outcome|PH-797804, 0.5 mg|Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864581|NCT00383188|OG001|Outcome|PH-797804, 3 mg|Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864582|NCT00383188|OG002|Outcome|PH-797804, 6 mg|Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864583|NCT00383188|OG003|Outcome|PH-797804, 10 mg|Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864584|NCT00383188|OG004|Outcome|Placebo|Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864585|NCT00383188|OG001|Outcome|PH-797804 ,3 mg|Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864586|NCT00383188|OG001|Outcome|PH-797804, 3 mg|Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug Individual participant participated in the study for a duration of up to 16 weeks.
10864587|NCT00383188|EG000|Reported Event|PH-797804, 0.5 mg|Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864588|NCT00383188|EG001|Reported Event|PH79804, 3 mg|Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864589|NCT00383188|EG002|Reported Event|PH-797804, 6 mg|Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864590|NCT00383188|EG003|Reported Event|PH-797804, 10 mg|Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864591|NCT00383188|EG004|Reported Event|Placebo|Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
10864592|NCT00383266|BG000|Baseline|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
10864593|NCT00383266|FG000|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
10864594|NCT00383266|OG000|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
10864595|NCT00383266|EG000|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
10864596|NCT00383292|BG000|Baseline|Tasisulam Dose Target 420 μg/mL Cmax|Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
10864597|NCT00383292|BG001|Baseline|Tasisulam Dose Target 360 μg/mL Cmax|Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
10864598|NCT00383292|BG002|Baseline|Tasisulam Albumin-Tailored Dose|Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
10864599|NCT00383292|BG003|Baseline|Total|Total of all reporting groups
10864600|NCT00383292|FG000|Participant Flow|Tasisulam Dose Target 420 μg/mL Cmax|Tasisulam loading dose targeting 420 micrograms/milliliter (μg/mL) maximum concentration (Cmax) at the end of infusion administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
10864601|NCT00383292|FG001|Participant Flow|Tasisulam Dose Target 360 μg/mL Cmax|Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
10864602|NCT00383292|FG002|Participant Flow|Tasisulam Albumin-Tailored Dose|Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
10864603|NCT00383292|OG000|Outcome|Tasisulam Dose Target 420 μg/mL Cmax|Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
10864604|NCT00383292|OG001|Outcome|Tasisulam Dose Target 360 μg/mL Cmax|Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
10864605|NCT00383292|OG002|Outcome|Tasisulam Albumin-Tailored Dose|Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
10864606|NCT00383292|OG000|Outcome|Tasisulam|Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Participants will receive a 2-hour intravenous infusion of study drug once every 28 days.
10864607|NCT00383292|EG000|Reported Event|Tasisulam Dose Target 420 μg/mL Cmax|Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
10864608|NCT00383292|EG001|Reported Event|Tasisulam Dose Target 360 μg/mL Cmax|Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
10864609|NCT00383292|EG002|Reported Event|Tasisulam Albumin-Tailored Dose|Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
10864610|NCT00383331|BG000|Baseline|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
10864611|NCT00383331|BG001|Baseline|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
10864612|NCT00383331|BG002|Baseline|Total|Total of all reporting groups
10864613|NCT00383331|FG000|Participant Flow|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
10864614|NCT00383331|FG001|Participant Flow|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
10864615|NCT00383331|OG000|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
10864616|NCT00383331|OG001|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
10864617|NCT00383331|EG000|Reported Event|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
10864618|NCT00383331|EG001|Reported Event|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
10864619|NCT00383448|BG000|Baseline|Treated Patients|"Patients receiving chemotherapy (Hydroxyurea, Alemtuzumab, Clofarabine, Melphalan), Hematopoietic Stem Cell Transplantation and radiation therapy (Total body Irradiation) mycophenylate mofetil and cyclosporine A.~Clofarabine: days -7 through -3: 40 mg/m^2 intravenously over 2 hours~Total body Irradiation: Administration of TBI: The dose of TBI will be 200 cGy given in a single fraction on day -1. The dose rate will be between 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.~Melphalan: day -2: 140 mg/m^2 intravenously over 30 minutes~Hematopoietic Stem Cell Transplantation: receives infusion of stem cells on day 0~Alemtuzumab: 0.3 mg/kg intravenously (IV) days -12 through -8~mycophenylate mofetil: Day -3 through Day 30: 1 gram three times daily (total daily dose 3 grams/day) if the recipient is >50 kg, or 15 mg/kg three times daily if the recipient is ≤50 kg. The same dosage is used orally or intravenously."
10864620|NCT00383448|FG000|Participant Flow|Treated Patients|"Patients receiving chemotherapy (Hydroxyurea, Alemtuzumab, Clofarabine, Melphalan), Hematopoietic Stem Cell Transplantation and radiation therapy (Total body Irradiation) mycophenylate mofetil and cyclosporine A.~Clofarabine: days -7 through -3: 40 mg/m^2 intravenously over 2 hours~Total body Irradiation: Administration of TBI: The dose of TBI will be 200 cGy given in a single fraction on day -1. The dose rate will be between 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.~Melphalan: day -2: 140 mg/m^2 intravenously over 30 minutes~Hematopoietic Stem Cell Transplantation: receives infusion of stem cells on day 0~Alemtuzumab: 0.3 mg/kg intravenously (IV) days -12 through -8~mycophenylate mofetil: Day -3 through Day 30: 1 gram three times daily (total daily dose 3 grams/day) if the recipient is >50 kg, or 15 mg/kg three times daily if the recipient is ≤50 kg. The same dosage is used orally or intravenously."
10864621|NCT00383448|OG000|Outcome|Treated Patients|"Patients receiving chemotherapy (Hydroxyurea, Alemtuzumab, Clofarabine, Melphalan), Hematopoietic Stem Cell Transplantation and radiation therapy (Total body Irradiation) mycophenylate mofetil and cyclosporine A.~Clofarabine: days -7 through -3: 40 mg/m^2 intravenously over 2 hours~Total body Irradiation: Administration of TBI: The dose of TBI will be 200 cGy given in a single fraction on day -1. The dose rate will be between 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.~Melphalan: day -2: 140 mg/m^2 intravenously over 30 minutes~Hematopoietic Stem Cell Transplantation: receives infusion of stem cells on day 0~Alemtuzumab: 0.3 mg/kg intravenously (IV) days -12 through -8~mycophenylate mofetil: Day -3 through Day 30: 1 gram three times daily (total daily dose 3 grams/day) if the recipient is >50 kg, or 15 mg/kg three times daily if the recipient is ≤50 kg. The same dosage is used orally or intravenously."
10864622|NCT00383448|OG000|Outcome|Treated Patients|Patients receiving chemotherapy (Hydroxyurea, Alemtuzumab, Clofarabine, Melphalan), Hematopoietic Stem Cell Transplantation and radiation therapy (Total body Irradiation) mycophenylate mofetil and cyclosporine A.
10864623|NCT00383448|EG000|Reported Event|Treated Patients|"Patients receiving chemotherapy (Hydroxyurea, Alemtuzumab, Clofarabine, Melphalan), Hematopoietic Stem Cell Transplantation and radiation therapy (Total body Irradiation) mycophenylate mofetil and cyclosporine A.~Clofarabine: days -7 through -3: 40 mg/m^2 intravenously over 2 hours~Total body Irradiation: Administration of TBI: The dose of TBI will be 200 cGy given in a single fraction on day -1. The dose rate will be between 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.~Melphalan: day -2: 140 mg/m^2 intravenously over 30 minutes~Hematopoietic Stem Cell Transplantation: receives infusion of stem cells on day 0~Alemtuzumab: 0.3 mg/kg intravenously (IV) days -12 through -8~mycophenylate mofetil: Day -3 through Day 30: 1 gram three times daily (total daily dose 3 grams/day) if the recipient is >50 kg, or 15 mg/kg three times daily if the recipient is ≤50 kg. The same dosage is used orally or intravenously."
10864624|NCT00383500|BG000|Baseline|Group I|This group of patients will receive the device.
10864625|NCT00383500|BG001|Baseline|Group II|This group of patients will receive prophylactic MLD
10864626|NCT00383500|BG002|Baseline|Group III|This is the control group; they will receive no treatment
10864627|NCT00383500|BG003|Baseline|Total|Total of all reporting groups
10864628|NCT00383500|FG000|Participant Flow|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
11223104|NCT02351037|OG000|Outcome|Ibrutinib Monotherapy Cohort|"Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.~Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis."
11223105|NCT02351037|OG001|Outcome|Ibrutinib + LD-AraC Combination Cohort|"Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.~Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle."
11223106|NCT02351037|OG002|Outcome|Ibrutinib+Azacitidine Combination Cohort|"Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).~Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles)."
10864629|NCT00383500|FG001|Participant Flow|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic massage therapy
10864630|NCT00383500|FG002|Participant Flow|No Intervention Control|No intervention observational control
10864631|NCT00383500|OG000|Outcome|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
10864632|NCT00383500|OG001|Outcome|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic drainage therapy
10864633|NCT00383500|OG002|Outcome|No Intervention Control|No intervention observational control
10864634|NCT00383500|OG001|Outcome|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic massage therapy
11223107|NCT02351037|EG000|Reported Event|Ibrutinib Monotherapy Cohort|"Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.~Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis."
11223108|NCT02351037|EG001|Reported Event|Ibrutinib + LD-AraC Combination Cohort|"Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.~Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle."
10864635|NCT00383500|EG000|Reported Event|Flexitouch Device|Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
10864636|NCT00383500|EG001|Reported Event|Manual Lymphatic Drainage (MLD)|Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment.
10864637|NCT00383500|EG002|Reported Event|Observational Control (no Intervention)|Control group, no intervention. No Flexitouch or manual massage therapy
10864638|NCT00383565|BG000|Baseline|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
10864639|NCT00383565|FG000|Participant Flow|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
10864640|NCT00383565|OG000|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
10864641|NCT00383565|EG000|Reported Event|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
10864642|NCT00383643|BG000|Baseline|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
10864643|NCT00383643|BG001|Baseline|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
10864644|NCT00383643|BG002|Baseline|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
10864645|NCT00383643|BG003|Baseline|Total|Total of all reporting groups
10864646|NCT00383643|FG000|Participant Flow|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
10864647|NCT00383643|FG001|Participant Flow|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
10864648|NCT00383643|FG002|Participant Flow|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
10864649|NCT00383643|OG000|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
10864650|NCT00383643|OG001|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
10864651|NCT00383643|OG002|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
10864652|NCT00383643|EG000|Reported Event|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
10864653|NCT00383643|EG001|Reported Event|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
10864654|NCT00383643|EG002|Reported Event|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
10864655|NCT00383747|BG000|Baseline|Non Smokers With Schizophrenia|
10864656|NCT00383747|BG001|Baseline|Controls|
10864657|NCT00383747|BG002|Baseline|Total|Total of all reporting groups
10864658|NCT00383747|FG000|Participant Flow|Non-smokers w/Schizophr: Nicotine Patch (V1) Then Placebo (V2)|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
10864659|NCT00383747|FG001|Participant Flow|Nonsmokers w/Schizophr: Placebo (V1) Then Nicotine Patch (V2)|Non smokers with schizophrenia received Placebo patch application then Nicotine patch: 14mg transdermal nicotine
10864660|NCT00383747|FG002|Participant Flow|Controls: Nicotine Patch (V1) Then Placebo (V2)|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
10864661|NCT00383747|FG003|Participant Flow|Controls: Placebo (V1) Then Nicotine Patch (V2)|Non-smoking adults without psychiatric illness received placebo patch then nicotine patch 14mg transdermal nicotine application
10864662|NCT00383747|OG000|Outcome|Non Smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
10864663|NCT00383747|OG001|Outcome|Non Smokers With Schizophrenia + Placebo Nicotine Patch|Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
10864664|NCT00383747|OG002|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
10864665|NCT00383747|OG003|Outcome|Controls + Placebo Nicotine Patch|Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
10864666|NCT00383747|OG000|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
10864667|NCT00383747|OG001|Outcome|Nonsmokers With Schizophrenia +, Placebo|Non smokers with schizophrenia received Placebo patch application
10864668|NCT00383747|OG002|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
10864669|NCT00383747|OG003|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
10864670|NCT00383747|OG001|Outcome|Nonsmokers With Schizophrenia + Placebo|Non smokers with schizophrenia received Placebo patch application
10864671|NCT00383747|EG000|Reported Event|Non Smokers With Schizophrenia|
10864672|NCT00383747|EG001|Reported Event|Controls|
10864673|NCT00383760|BG000|Baseline|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: 1.4mg/m2 given IV weekly day 1,8 every 21 days (1 cycle)."
10864674|NCT00383760|FG000|Participant Flow|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
10864675|NCT00383760|OG000|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
10864676|NCT00383760|OG000|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
10864677|NCT00383760|EG000|Reported Event|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
10864678|NCT00383786|BG000|Baseline|GR205171|selective neurokinin-1 receptor antagonist
10864679|NCT00383786|BG001|Baseline|Placebo|sugar pill
10864680|NCT00383786|BG002|Baseline|Total|Total of all reporting groups
10864681|NCT00383786|FG000|Participant Flow|GR205171|selective neurokinin-1 receptor antagonist, 5mg/day for a period of 8 weeks
10864682|NCT00383786|FG001|Participant Flow|Placebo|sugar pill administered daily for a period of 8 weeks
10864683|NCT00383786|OG000|Outcome|GR205171|
10864684|NCT00383786|OG001|Outcome|Placebo|
10864685|NCT00383786|EG000|Reported Event|GR205171|selective neurokinin-1 receptor antagonist
10864686|NCT00383786|EG001|Reported Event|Placebo|sugar pill
10864687|NCT00383942|BG000|Baseline|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
10864688|NCT00383942|BG001|Baseline|EASI|Patients randomized to this arm receive extra amniotic saline infusion via a catheter that is placed in the uterus
10864689|NCT00383942|BG002|Baseline|Total|Total of all reporting groups
10864690|NCT00383942|FG000|Participant Flow|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
10864691|NCT00383942|FG001|Participant Flow|EASI|Patients randomized to this arm receive an extra amniotic saline infusion via catheter that is placed in the uterus
10864692|NCT00383942|OG000|Outcome|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
10864693|NCT00383942|OG001|Outcome|EASI|Patients randomized to this arm recieve extra amniotic saline infusion (EASI) via a catheter that is placed in the uterus
10864694|NCT00383942|EG000|Reported Event|Misoprostol|Patients assigned to this arm received 25 micrograms of misoprostol every 4 hours
10864695|NCT00383942|EG001|Reported Event|EASI|Patients assigned to this arm received extra amniotic saline infusion via a catheter that is placed in the uterus
10864696|NCT00384033|BG000|Baseline|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864697|NCT00384033|BG001|Baseline|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864698|NCT00384033|BG002|Baseline|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864699|NCT00384033|BG003|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
10864700|NCT00384033|BG004|Baseline|Total|Total of all reporting groups
10864701|NCT00384033|FG000|Participant Flow|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864702|NCT00384033|FG001|Participant Flow|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864703|NCT00384033|FG002|Participant Flow|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864704|NCT00384033|FG003|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
10864705|NCT00384033|OG000|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864706|NCT00384033|OG001|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864707|NCT00384033|OG002|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864708|NCT00384033|OG003|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
10864709|NCT00384033|EG000|Reported Event|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864710|NCT00384033|EG001|Reported Event|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864711|NCT00384033|EG002|Reported Event|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
10864712|NCT00384033|EG003|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
10864713|NCT00384059|BG000|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
10864714|NCT00384059|BG001|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
10864715|NCT00384059|BG002|Baseline|Total|Total of all reporting groups
10864716|NCT00384059|FG000|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
10864717|NCT00384059|FG001|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
10864718|NCT00384059|OG000|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
10864719|NCT00384059|OG001|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
10864720|NCT00384059|OG000|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
10864721|NCT00384059|OG001|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
10864722|NCT00384059|OG002|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
10864723|NCT00384059|OG003|Outcome|7vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
10864724|NCT00384059|OG000|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
10864725|NCT00384059|OG001|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
10864726|NCT00384059|OG000|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
10864727|NCT00384059|OG001|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
10864728|NCT00384059|OG002|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
10864729|NCT00384059|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
10864730|NCT00384059|OG001|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
10864731|NCT00384059|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
10864732|NCT00384059|OG003|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
10864733|NCT00384059|OG004|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
10864734|NCT00384059|OG005|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
10864735|NCT00384059|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
10864736|NCT00384059|EG001|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
10864737|NCT00384059|EG002|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
10864738|NCT00384059|EG003|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
10864739|NCT00384059|EG004|Reported Event|13vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
10864740|NCT00384059|EG005|Reported Event|7vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
10864741|NCT00384059|EG006|Reported Event|13vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) & Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose).
10864742|NCT00384059|EG007|Reported Event|7vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose).
10864743|NCT00384085|BG000|Baseline|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
10864744|NCT00384085|BG001|Baseline|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
10864745|NCT00384085|BG002|Baseline|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
10864746|NCT00384085|BG003|Baseline|Total|Total of all reporting groups
10864747|NCT00384085|FG000|Participant Flow|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
10864748|NCT00384085|FG001|Participant Flow|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
10864749|NCT00384085|FG002|Participant Flow|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
10864750|NCT00384085|OG000|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
10864751|NCT00384085|OG001|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
10864752|NCT00384085|OG000|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
10864753|NCT00384085|OG001|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
10864754|NCT00384085|OG002|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
10864755|NCT00384085|EG000|Reported Event|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
10864756|NCT00384085|EG001|Reported Event|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
10864757|NCT00384085|EG002|Reported Event|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
10864758|NCT00384176|BG000|Baseline|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864759|NCT00384176|BG001|Baseline|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864760|NCT00384176|BG002|Baseline|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864761|NCT00384176|BG003|Baseline|Total|Total of all reporting groups
10864762|NCT00384176|FG000|Participant Flow|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864763|NCT00384176|FG001|Participant Flow|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864764|NCT00384176|FG002|Participant Flow|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864765|NCT00384176|OG000|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864766|NCT00384176|OG001|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864767|NCT00384176|OG002|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864768|NCT00384176|EG000|Reported Event|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864769|NCT00384176|EG001|Reported Event|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
10864770|NCT00384176|EG002|Reported Event|1Bevacizumab 5mg/kg|Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
10864771|NCT00384189|BG000|Baseline|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864772|NCT00384189|BG001|Baseline|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864773|NCT00384189|BG002|Baseline|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864774|NCT00384189|BG003|Baseline|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864775|NCT00384189|BG004|Baseline|Total|Total of all reporting groups
10864776|NCT00384189|FG000|Participant Flow|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864777|NCT00384189|FG001|Participant Flow|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864778|NCT00384189|FG002|Participant Flow|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10977072|NCT00943579|FG000|Participant Flow|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
10864779|NCT00384189|FG003|Participant Flow|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864780|NCT00384189|OG000|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864781|NCT00384189|OG001|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864782|NCT00384189|OG002|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864783|NCT00384189|OG003|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864784|NCT00384189|EG000|Reported Event|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864785|NCT00384189|EG001|Reported Event|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864786|NCT00384189|EG002|Reported Event|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864787|NCT00384189|EG003|Reported Event|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
10864788|NCT00384241|BG000|Baseline|Children|African American and Caucasian children age 15-19.
10864789|NCT00384241|BG001|Baseline|Parents|African American and Caucasian parents, age 18-65.
10864790|NCT00384241|BG002|Baseline|Total|Total of all reporting groups
10864791|NCT00384241|FG000|Participant Flow|Children|Genotyping and IL-6 levels of 500 children enrolled in two previous studies were collected in the current study. Other phenotype data: Baseline blood pressure, stress blood pressure, and recovery blood pressure; Baseline stress and recovery urinary sodium excretion that were collected in two previous studies were utilized in the current study.
10864792|NCT00384241|FG001|Participant Flow|Parents|Buccal swabs from the Parents of 500 subjects in the children arm were collected and analyzed for genetic variations. Some parents submitted duplicate swabs if more than 1 child was represented in the 500 subjects.
10864793|NCT00384241|OG000|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
10864794|NCT00384241|EG000|Reported Event|Children|African American and Caucasian children age 15 - 19.
10864795|NCT00384241|EG001|Reported Event|Parents|African American and Caucasian parents age 18 - 65
10864796|NCT00384332|BG000|Baseline|Arm 1|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
10864797|NCT00384332|BG001|Baseline|Arm 2|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
10864798|NCT00384332|BG002|Baseline|Total|Total of all reporting groups
10864799|NCT00384332|FG000|Participant Flow|Arm 1- ODT|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
10864800|NCT00384332|FG001|Participant Flow|Arm 2- SOT|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
10864801|NCT00384332|OG000|Outcome|Arm 1- ODT|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
10864802|NCT00384332|OG001|Outcome|Arm 2- SOT|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
10864803|NCT00384332|OG000|Outcome|Arm 1|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
10864804|NCT00384332|OG001|Outcome|Arm 2|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
10864805|NCT00384332|EG000|Reported Event|Arm 1- ODT|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
10864806|NCT00384332|EG001|Reported Event|Arm 2- SOT|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
10864807|NCT00384397|BG000|Baseline|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
10864808|NCT00384397|BG001|Baseline|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
10864809|NCT00384397|BG002|Baseline|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
10864810|NCT00384397|BG003|Baseline|Total|Total of all reporting groups
10864811|NCT00384397|FG000|Participant Flow|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
10864812|NCT00384397|FG001|Participant Flow|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
10864813|NCT00384397|FG002|Participant Flow|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
10864814|NCT00384397|OG000|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
10864815|NCT00384397|OG001|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
10864816|NCT00384397|OG002|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
10864817|NCT00384397|EG000|Reported Event|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
10864818|NCT00384397|EG001|Reported Event|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
10864819|NCT00384397|EG002|Reported Event|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
10864820|NCT00384449|BG000|Baseline|Lucentis (Ranibizumab)|Three monthly intravitreal injections of 0.5 mg ranibizumab
10864821|NCT00384449|FG000|Participant Flow|Lucentis (Ranibizumab)|Three monthly intravitreal injections of 0.5 mg ranibizumab
10864822|NCT00384449|OG000|Outcome|Lucentis (Ranibizumab)|"Lucentis (ranibizumab)~Ranibizumab: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months"
10864823|NCT00384449|EG000|Reported Event|Lucentis (Ranibizumab)|Three monthly intravitreal injections of 0.5 mg of ranibizumab
10864824|NCT00384670|BG000|Baseline|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
10864825|NCT00384670|FG000|Participant Flow|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
10864826|NCT00384670|OG000|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
10864827|NCT00384670|EG000|Reported Event|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
10864828|NCT00384748|BG000|Baseline|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
10864829|NCT00384748|BG001|Baseline|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
10864830|NCT00384748|BG002|Baseline|Total|Total of all reporting groups
10864831|NCT00384748|FG000|Participant Flow|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
10977073|NCT00943579|FG001|Participant Flow|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
10864832|NCT00384748|FG001|Participant Flow|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
10864833|NCT00384748|OG000|Outcome|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
10864834|NCT00384748|OG001|Outcome|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
10864835|NCT00384748|EG000|Reported Event|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
10864836|NCT00384748|EG001|Reported Event|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
10864837|NCT00384774|BG000|Baseline|Placebo|Participants received intravenous infusion of placebo solution.
10864838|NCT00384774|BG001|Baseline|Lasmiditan 2.5 mg|Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
10864839|NCT00384774|BG002|Baseline|Lasmiditan 5.0 mg|Participants received 5 mg of lasmiditan administered as intravenous infusion.
10864840|NCT00384774|BG003|Baseline|Lasmiditan 10 mg|Participants received 10 mg of lasmiditan administered as intravenous infusion.
10864841|NCT00384774|BG004|Baseline|Lasmiditan 20 mg|Participants received 20 mg of lasmiditan administered as intravenous infusion.
10864842|NCT00384774|BG005|Baseline|Lasmiditan 30 mg|Participants received 30 mg of lasmiditan administered as intravenous infusion.
10864843|NCT00384774|BG006|Baseline|Lasmiditan 45 mg|Participants received 45 mg of lasmiditan administered as intravenous infusion.
10864844|NCT00384774|BG007|Baseline|Total|Total of all reporting groups
10864845|NCT00384774|FG000|Participant Flow|Placebo|Participants received intravenous infusion of placebo solution.
10864846|NCT00384774|FG001|Participant Flow|Lasmiditan 2.5 mg|Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
10864847|NCT00384774|FG002|Participant Flow|Lasmiditan 5.0 mg|Participants received 5 mg of lasmiditan administered as intravenous infusion.
10864848|NCT00384774|FG003|Participant Flow|Lasmiditan 10 mg|Participants received 10 mg of lasmiditan administered as intravenous infusion.
10864849|NCT00384774|FG004|Participant Flow|Lasmiditan 20 mg|Participants received 20 mg of lasmiditan administered as intravenous infusion.
10864850|NCT00384774|FG005|Participant Flow|Lasmiditan 30 mg|Participants received 30 mg of lasmiditan administered as intravenous infusion.
10864851|NCT00384774|FG006|Participant Flow|Lasmiditan 45 mg|Participants received 45 mg of lasmiditan administered as intravenous infusion.
10864852|NCT00384774|OG000|Outcome|Placebo|Participants received intravenous infusion of placebo solution.
10864853|NCT00384774|OG001|Outcome|Lasmiditan 2.5 mg|Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
10864854|NCT00384774|OG002|Outcome|Lasmiditan 5.0 mg|Participants received 5 mg of lasmiditan administered as intravenous infusion.
10864855|NCT00384774|OG003|Outcome|Lasmiditan 10 mg|Participants received 10 mg of lasmiditan administered as intravenous infusion.
10864856|NCT00384774|OG004|Outcome|Lasmiditan 20 mg|Participants received 20 mg of lasmiditan administered as intravenous infusion.
10864857|NCT00384774|OG005|Outcome|Lasmiditan 30 mg|Participants received 30 mg of lasmiditan administered as intravenous infusion.
10864858|NCT00384774|OG006|Outcome|Lasmiditan 45 mg|Participants received 45 mg of lasmiditan administered as intravenous infusion.
10864859|NCT00384774|EG000|Reported Event|Placebo|Participants received intravenous injection of placebo solution.
10864860|NCT00384774|EG001|Reported Event|Lasmiditan 2.5 mg|Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
10864861|NCT00384774|EG002|Reported Event|Lasmiditan 5.0 mg|Participants received 5 mg of lasmiditan administered as intravenous infusion.
10864862|NCT00384774|EG003|Reported Event|Lasmiditan 10 mg|Participants received 10 mg of lasmiditan administered as intravenous infusion.
10864863|NCT00384774|EG004|Reported Event|Lasmiditan 20 mg|Participants received 20 mg of lasmiditan administered as intravenous infusion.
10864864|NCT00384774|EG005|Reported Event|Lasmiditan 30 mg|Participants received 30 mg of lasmiditan administered as intravenous infusion.
10864865|NCT00384774|EG006|Reported Event|Lasmiditan 45 mg|Participants received 45 mg of lasmiditan administered as intravenous infusion.
10864866|NCT00384813|BG000|Baseline|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
10864867|NCT00384813|BG001|Baseline|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
10864868|NCT00384813|BG002|Baseline|Total|Total of all reporting groups
10864869|NCT00384813|FG000|Participant Flow|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
10864870|NCT00384813|FG001|Participant Flow|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
10864871|NCT00384813|OG000|Outcome|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
10864872|NCT00384813|OG001|Outcome|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
10864873|NCT00384813|EG000|Reported Event|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
10864874|NCT00384813|EG001|Reported Event|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
10864875|NCT00384839|BG000|Baseline|Vidaza|azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
10864876|NCT00384839|FG000|Participant Flow|Vidaza|azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
10864877|NCT00384839|OG000|Outcome|Vidaza|azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
10864878|NCT00384839|EG000|Reported Event|Vidaza|azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
10864879|NCT00384865|BG000|Baseline|Aspirin 81 mg + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months~Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months"
10864880|NCT00384865|BG001|Baseline|Aspirin 81 mg + Placebo|"Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months~Placebo: Placebo, taken orally, once a day for 6 months"
10864881|NCT00384865|BG002|Baseline|Placebo + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months~Placebo: Placebo, taken orally, once a day for 6 months"
10864882|NCT00384865|BG003|Baseline|Placebo + Placebo|Placebo: Placebo, taken orally, once a day for 6 months
10864883|NCT00384865|BG004|Baseline|Total|Total of all reporting groups
10864884|NCT00384865|FG000|Participant Flow|Aspirin 81 mg + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months~Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months"
10864885|NCT00384865|FG001|Participant Flow|Aspirin 81 mg + Placebo|"Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months~Placebo: Placebo, taken orally, once a day for 6 months"
10864886|NCT00384865|FG002|Participant Flow|Placebo + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months~Placebo: Placebo, taken orally, once a day for 6 months"
10864887|NCT00384865|FG003|Participant Flow|Placebo + Placebo|Placebo: Placebo, taken orally, once a day for 6 months
10864888|NCT00384865|OG000|Outcome|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
10864889|NCT00384865|OG001|Outcome|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
10864890|NCT00384865|OG002|Outcome|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
10864891|NCT00384865|OG003|Outcome|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
10864892|NCT00384865|EG000|Reported Event|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
10864893|NCT00384865|EG001|Reported Event|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
10864894|NCT00384865|EG002|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
10864895|NCT00384865|EG003|Reported Event|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
10864896|NCT00384930|BG000|Baseline|Placebo|placebo tablet by mouth once a day for twelve weeks
10864897|NCT00384930|BG001|Baseline|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
10864898|NCT00384930|BG002|Baseline|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
10864899|NCT00384930|BG003|Baseline|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
10864900|NCT00384930|BG004|Baseline|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
10864901|NCT00384930|BG005|Baseline|Total|Total of all reporting groups
10864902|NCT00384930|FG000|Participant Flow|Placebo|placebo tablet by mouth once a day for twelve weeks
10864903|NCT00384930|FG001|Participant Flow|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
10864904|NCT00384930|FG002|Participant Flow|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
10864905|NCT00384930|FG003|Participant Flow|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
10864906|NCT00384930|FG004|Participant Flow|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
10864907|NCT00384930|OG000|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
10864908|NCT00384930|OG001|Outcome|5 mg Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
10864909|NCT00384930|OG000|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
10864910|NCT00384930|OG001|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
10864911|NCT00384930|OG002|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
10864912|NCT00384930|OG003|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
10864913|NCT00384930|OG004|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
10864914|NCT00384930|OG002|Outcome|5.0 mg Tadalafil|5.0 mg tadalafil tablet by mouth once a day for twelve weeks
10864915|NCT00384930|EG000|Reported Event|Placebo|placebo tablet by mouth once a day for twelve weeks
10864916|NCT00384930|EG001|Reported Event|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
10864917|NCT00384930|EG002|Reported Event|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
10864918|NCT00384930|EG003|Reported Event|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
10864919|NCT00384930|EG004|Reported Event|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
10864920|NCT00384956|BG000|Baseline|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
10864921|NCT00384956|FG000|Participant Flow|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
10864922|NCT00384956|OG000|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
10864923|NCT00384956|EG000|Reported Event|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
10864924|NCT00385008|BG000|Baseline|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
10864925|NCT00385008|BG001|Baseline|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
10864926|NCT00385008|BG002|Baseline|Total|Total of all reporting groups
10864927|NCT00385008|FG000|Participant Flow|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 milliliter (mL) of water.
10977074|NCT00943579|OG000|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
10864928|NCT00385008|FG001|Participant Flow|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
10864929|NCT00385008|OG000|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
10864930|NCT00385008|OG001|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
10864931|NCT00385008|OG000|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
10864932|NCT00385008|EG000|Reported Event|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
10864933|NCT00385008|EG001|Reported Event|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
10864934|NCT00385138|BG000|Baseline|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
10864935|NCT00385138|BG001|Baseline|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
10864936|NCT00385138|BG002|Baseline|Total|Total of all reporting groups
10864937|NCT00385138|FG000|Participant Flow|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
10864938|NCT00385138|FG001|Participant Flow|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
10864939|NCT00385138|OG000|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
10864940|NCT00385138|OG001|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
10864941|NCT00385138|EG000|Reported Event|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
10864942|NCT00385138|EG001|Reported Event|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
10864943|NCT00385203|BG000|Baseline|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day: 25 patients with Gastrointestinal Stromal Tumour (GIST) randomised
10864944|NCT00385203|BG001|Baseline|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day: 10 patients with Soft Tissue Sarcomas (STS) randomised
10864945|NCT00385203|BG002|Baseline|Total|Total of all reporting groups
10864946|NCT00385203|FG000|Participant Flow|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
10864947|NCT00385203|FG001|Participant Flow|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
10864948|NCT00385203|OG000|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
10864949|NCT00385203|OG001|Outcome|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment
10864950|NCT00385203|OG001|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
10864951|NCT00385203|EG000|Reported Event|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day patients with Gastrointestinal Stromal Tumour (GIST): 24 patients randomised and received at least one dose of treatment (1 patient was not randomised or dosed and a further 1 patient was randomised but not dosed due to Incorrect enrolmentCediranib)
10864952|NCT00385203|EG001|Reported Event|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment.
10864953|NCT00385216|BG000|Baseline|Entire Study Population|The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical.
10864954|NCT00385216|FG000|Participant Flow|Nicotine Nasal Spray First, Then Placebo|At the first intervention, the subject will receive a nicotine nasal spray, 3 mg, one application. At the second intervention, the subject will receive a placebo nasal spray, 0 mg, one application.
10864955|NCT00385216|FG001|Participant Flow|Placebo Spray First, Then Nicotine|At the first intervention, the subject will receive a placebo nasal spray, 0 mg, one application. At the second intervention, the subject will receive a nicotine nasal spray, 3 mg, one application.
10864956|NCT00385216|OG000|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
10864957|NCT00385216|OG001|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
10864958|NCT00385216|EG000|Reported Event|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
10864959|NCT00385216|EG001|Reported Event|Placebo|Sterile saline nasal spray was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
10864960|NCT00385255|BG000|Baseline|Boostrix+Fluarix Group|Healthy male or female adults, aged between 19 to 64 years inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
10864961|NCT00385255|BG001|Baseline|Fluarix Boostrix Group|Healthy male or female adults, aged between 19 to 64 years inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
10864962|NCT00385255|BG002|Baseline|Total|Total of all reporting groups
10864963|NCT00385255|FG000|Participant Flow|Boostrix+Fluarix Group|Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
10864964|NCT00385255|FG001|Participant Flow|Fluarix Boostrix Group|Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
10864965|NCT00385255|OG000|Outcome|Boostrix+Fluarix 19-64 YOA Group|Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
10864966|NCT00385255|OG001|Outcome|Fluarix Boostrix 19-64 YOA Group|Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
10864967|NCT00385255|OG002|Outcome|Boostrix+Fluarix ≥ 65 YOA Group|Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
10864968|NCT00385255|OG003|Outcome|Fluarix Boostrix ≥ 65 YOA Group|Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
11348754|NCT04136444|BG001|Baseline|Cohort B|Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
10864969|NCT00385255|OG000|Outcome|Boostrix+Fluarix 19-64 YOA Group|Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
10864970|NCT00385255|OG001|Outcome|Fluarix Boostrix 19-64 YOA Group|Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
10864971|NCT00385255|EG000|Reported Event|Boostrix+Fluarix Group|Healthy male or female adults, aged between 19 to 64 years inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
10864972|NCT00385255|EG001|Reported Event|Fluarix Boostrix Group|Healthy male or female adults, aged between 19 to 64 years inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
10864973|NCT00385268|BG000|Baseline|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
10864974|NCT00385268|BG001|Baseline|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
10864975|NCT00385268|BG002|Baseline|Total|Total of all reporting groups
10864976|NCT00385268|FG000|Participant Flow|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
10864977|NCT00385268|FG001|Participant Flow|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
10864978|NCT00385268|OG000|Outcome|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
10864979|NCT00385268|OG001|Outcome|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
10864980|NCT00385268|EG000|Reported Event|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
10864981|NCT00385268|EG001|Reported Event|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
10864982|NCT00385541|BG000|Baseline|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
10864983|NCT00385541|BG001|Baseline|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
10864984|NCT00385541|BG002|Baseline|Total|Total of all reporting groups
10864985|NCT00385541|FG000|Participant Flow|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
10864986|NCT00385541|FG001|Participant Flow|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
10977075|NCT00943579|OG001|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
11223109|NCT02351037|EG002|Reported Event|Ibrutinib+Azacitidine Combination Cohort|"Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).~Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles)."
11223110|NCT02351115|BG000|Baseline|BEADC BEADC|Patient receiving treatment sequence BEADC
11223111|NCT02351115|BG001|Baseline|CDAEB|Patient receiving treatment sequence CDAEB
11223112|NCT02351115|BG002|Baseline|DEBAC|Patient receiving treatment sequence DEBAC
11223113|NCT02351115|BG003|Baseline|EDBAC|Patient receiving treatment sequence EDBAC
11223114|NCT02351115|BG004|Baseline|CABED|Patient receiving treatment sequence CABED
11223115|NCT02351115|BG005|Baseline|Total|Total of all reporting groups
11223116|NCT02351115|FG000|Participant Flow|BEADC|Patient receiving treatment sequence BEADC
10864987|NCT00385541|OG000|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
10864988|NCT00385541|OG001|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
10864989|NCT00385541|EG000|Reported Event|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
10864990|NCT00385541|EG001|Reported Event|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
10864991|NCT00385580|BG000|Baseline|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10864992|NCT00385580|BG001|Baseline|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10864993|NCT00385580|BG002|Baseline|Total|Total of all reporting groups
10864994|NCT00385580|FG000|Participant Flow|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10864995|NCT00385580|FG001|Participant Flow|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10864996|NCT00385580|OG000|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10977076|NCT00943579|OG000|Outcome|Kuvan Following Placebo|
10977077|NCT00943579|OG001|Outcome|Kuvan Following Active Treatment|
11223117|NCT02351115|FG001|Participant Flow|CDAEB|Patient receiving treatment sequence CDAEB
11223118|NCT02351115|FG002|Participant Flow|DEBAC|Patient receiving treatment sequence DEBAC
11223119|NCT02351115|FG003|Participant Flow|EDBAC|Patient receiving treatment sequence EDBAC
11223120|NCT02351115|FG004|Participant Flow|CABED|Patient receiving treatment sequence CABED
11223121|NCT02351115|OG000|Outcome|Inhaled Placebo|All patients receiving inhaled placebo in this 4 treatment complete crossover study
11348755|NCT04136444|BG002|Baseline|Total Title|
10864997|NCT00385580|OG001|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10977078|NCT00943579|OG000|Outcome|Kuvan®|"Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks.~Kuvan®: Brand-name Kuvan® (sapropterin) will be administered to all subjects at a dose of 20 mg/kg/day for 16 weeks."
10864998|NCT00385580|OG000|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10864999|NCT00385580|OG001|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865000|NCT00385580|OG002|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865001|NCT00385580|OG000|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865002|NCT00385580|OG001|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865003|NCT00385580|OG002|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865004|NCT00385580|OG000|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865005|NCT00385580|OG001|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (50 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865006|NCT00385580|OG002|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (50 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10977079|NCT00943579|EG000|Reported Event|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
10977080|NCT00943579|EG001|Reported Event|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
10977081|NCT00943592|BG000|Baseline|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
11223122|NCT02351115|OG001|Outcome|Staccato Alprazolam, 0.5 mg|All patients receiving 0.5 mg inhaled alprazolam in this 4 treatment complete crossover study
10865007|NCT00385580|OG001|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (X dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865008|NCT00385580|OG002|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (X dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
10865009|NCT00385580|EG000|Reported Event|Dasatinib|All treated participants
10865010|NCT00385593|BG000|Baseline|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
10865011|NCT00385593|BG001|Baseline|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
10865012|NCT00385593|BG002|Baseline|Total|Total of all reporting groups
10865013|NCT00385593|FG000|Participant Flow|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
10865014|NCT00385593|FG001|Participant Flow|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
10865015|NCT00385593|OG000|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
10865016|NCT00385593|OG001|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
10865017|NCT00385593|EG000|Reported Event|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
10865018|NCT00385593|EG001|Reported Event|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
10865019|NCT00385671|BG000|Baseline|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
10865020|NCT00385671|BG001|Baseline|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
10865021|NCT00385671|BG002|Baseline|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
10865022|NCT00385671|BG003|Baseline|Total|Total of all reporting groups
10865023|NCT00385671|FG000|Participant Flow|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
10865024|NCT00385671|FG001|Participant Flow|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
10865025|NCT00385671|FG002|Participant Flow|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
10865026|NCT00385671|OG000|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
10865027|NCT00385671|OG001|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
11223123|NCT02351115|OG002|Outcome|Staccato Alprazolam, 1 mg|All patients receiving 1 mg inhaled alprazolam in this 4 treatment complete crossover study
10865028|NCT00385671|OG000|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
10865029|NCT00385671|OG002|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
10865030|NCT00385671|OG000|Outcome|Ordinary Coefficient|Beta-coefficient from regression analyses estimating direct and indirect treatment effects expressed in the observed scale of measurement of the dependent variable.
10865031|NCT00385671|EG000|Reported Event|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
10865032|NCT00385671|EG001|Reported Event|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
10865033|NCT00385671|EG002|Reported Event|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
10865034|NCT00385684|BG000|Baseline|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
10879138|NCT00455689|OG000|Outcome|Developed Hot Flashes|"Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)~Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection~Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women."
11223124|NCT02351115|OG003|Outcome|Staccato Alprazolam, 2 mg|All patients receiving 2 mg inhaled alprazolam in this 4 treatment complete crossover study
11223125|NCT02351115|OG000|Outcome|Staccato Alprazolam, 0.5 mg|All patients receiving 0.5 mg inhaled alprazolam in this 4 treatment complete crossover study
11223126|NCT02351115|OG001|Outcome|Staccato Alprazolam, 1 mg|All patients receiving 1 mg inhaled alprazolam in this 4 treatment complete crossover study
10865035|NCT00385684|FG000|Participant Flow|A1 and Then A2 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
10865036|NCT00385684|FG001|Participant Flow|A2 THEN A1 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
10865037|NCT00385684|OG000|Outcome|Experimental: A1|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
10865038|NCT00385684|OG001|Outcome|Placebo Comparator: A2|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
10865039|NCT00385684|OG000|Outcome|Phase B: Open Label|Those participants for whom the study medication was tolerated during Phase A (i.e., the closed label, double-blind phase of the trial) entered a six-week open-label phase.
10865040|NCT00385684|EG000|Reported Event|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
10865041|NCT00385723|BG000|Baseline|Placebo|Placebo : matching placebo capsule daily for 4 months
10865042|NCT00385723|BG001|Baseline|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
10865043|NCT00385723|BG002|Baseline|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
10865044|NCT00385723|BG003|Baseline|Total|Total of all reporting groups
10865045|NCT00385723|FG000|Participant Flow|Placebo|Placebo : matching placebo capsule daily for 4 months
10865046|NCT00385723|FG001|Participant Flow|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
10865047|NCT00385723|FG002|Participant Flow|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
10865048|NCT00385723|OG000|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
10865049|NCT00385723|OG001|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
10865050|NCT00385723|OG002|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
10865051|NCT00385723|EG000|Reported Event|Placebo|Placebo : matching placebo capsule daily for 4 months
10865052|NCT00385723|EG001|Reported Event|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
10865053|NCT00385723|EG002|Reported Event|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
10865054|NCT00385736|BG000|Baseline|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
10865055|NCT00385736|BG001|Baseline|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
10865056|NCT00385736|BG002|Baseline|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
10865057|NCT00385736|BG003|Baseline|Total|Total of all reporting groups
10865058|NCT00385736|FG000|Participant Flow|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
10865059|NCT00385736|FG001|Participant Flow|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
10865060|NCT00385736|FG002|Participant Flow|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
11223127|NCT02351115|OG002|Outcome|Staccato Alprazolam, 2 mg|All patients receiving 2 mg inhaled alprazolam in this 4 treatment complete crossover study
10865061|NCT00385736|OG000|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
10865062|NCT00385736|OG001|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
10865063|NCT00385736|OG002|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
10865064|NCT00385736|OG001|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
10865065|NCT00385736|OG000|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
10865066|NCT00385736|EG000|Reported Event|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6. Adverse events include those reported prior to dosing at Week 8.
10865067|NCT00385736|EG001|Reported Event|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
10865068|NCT00385736|EG002|Reported Event|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
10865069|NCT00385736|EG003|Reported Event|Any Adalimumab|Treatment group received at least 1 dose of adalimumab during the study. Adverse events include those reported from the first dose of adalimumab during the double-blind or open-label period.
10865070|NCT00385762|BG000|Baseline|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
10865071|NCT00385762|FG000|Participant Flow|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
10865072|NCT00385762|OG000|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
10865073|NCT00385762|EG000|Reported Event|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
10865074|NCT00385788|BG000|Baseline|Fludarabine + Melphalan|Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
10865075|NCT00385788|BG001|Baseline|Gemcitabine + Fludarabine + Melphalan|Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
10865076|NCT00385788|BG002|Baseline|Total|Total of all reporting groups
10865077|NCT00385788|FG000|Participant Flow|Fludarabine + Melphalan|Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
11223128|NCT02351115|EG000|Reported Event|Inhaled Placebo|All patients receiving inhaled placebo in this 4 treatment complete crossover study
10865078|NCT00385788|FG001|Participant Flow|Gemcitabine + Fludarabine + Melphalan|Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
10865079|NCT00385788|OG000|Outcome|Fludarabine + Melphalan|Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
10865080|NCT00385788|OG001|Outcome|Gemcitabine + Fludarabine + Melphalan|Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
10865081|NCT00385788|EG000|Reported Event|Fludarabine + Melphalan|Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
10865082|NCT00385788|EG001|Reported Event|Gemcitabine + Fludarabine + Melphalan|Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
10865083|NCT00385801|BG000|Baseline|Placebo|Identical placebo tablets and injections
11223129|NCT02351115|EG001|Reported Event|Staccato® Alprazolam, 0.5 mg|All patients receiving 0.5 mg inhaled alprazolam in this 4 treatment complete crossover study
11223130|NCT02351115|EG002|Reported Event|Staccato® Alprazolam, 1 mg|All patients receiving 1 mg inhaled alprazolam in this 4 treatment complete crossover study
10865084|NCT00385801|BG001|Baseline|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
10865085|NCT00385801|BG002|Baseline|Total|Total of all reporting groups
10865086|NCT00385801|FG000|Participant Flow|Placebo|Identical placebo tablets and injections
10865087|NCT00385801|FG001|Participant Flow|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
10865088|NCT00385801|OG000|Outcome|Placebo|Identical placebo tablets and injections
10865089|NCT00385801|OG001|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
10865090|NCT00385801|OG001|Outcome|Risperidone|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
10865091|NCT00385801|EG000|Reported Event|Placebo|Identical placebo tablets and injections
10865092|NCT00385801|EG001|Reported Event|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
10865093|NCT00385827|BG000|Baseline|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
10865094|NCT00385827|BG001|Baseline|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865095|NCT00385827|BG002|Baseline|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865096|NCT00385827|BG003|Baseline|Total|Total of all reporting groups
10865097|NCT00385827|FG000|Participant Flow|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
10865098|NCT00385827|FG001|Participant Flow|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865099|NCT00385827|FG002|Participant Flow|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865100|NCT00385827|OG000|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
11223131|NCT02351115|EG003|Reported Event|Staccato® Alprazolam, 2 mg|All patients receiving 2 mg inhaled alprazolam in this 4 treatment complete crossover study
10865101|NCT00385827|OG000|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865102|NCT00385827|OG001|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865103|NCT00385827|OG001|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865104|NCT00385827|OG002|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865105|NCT00385827|EG000|Reported Event|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
10865106|NCT00385827|EG001|Reported Event|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865107|NCT00385827|EG002|Reported Event|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
10865108|NCT00385840|BG000|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10865109|NCT00385840|BG001|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10865110|NCT00385840|BG002|Baseline|Total|Total of all reporting groups
10865111|NCT00385840|FG000|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10865112|NCT00385840|FG001|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10865113|NCT00385840|OG000|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10865114|NCT00385840|OG001|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10865115|NCT00385840|EG000|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10865116|NCT00385840|EG001|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10865117|NCT00385918|BG000|Baseline|Lokomat Exercise|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
10865118|NCT00385918|BG001|Baseline|Home Stretching Then Lokomat Exercise|"Patients will participate in a home stretching program for 3 months. They will then be crossed over to Lokomat treatment for an additional 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm."
10865119|NCT00385918|BG002|Baseline|Total|Total of all reporting groups
10865120|NCT00385918|FG000|Participant Flow|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
10865121|NCT00385918|FG001|Participant Flow|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~After 3 months the participants will be switched to a 3 month period of Lokomat training the same as that offered to the patients randomized to the Lokomat Training arm of the study."
10865122|NCT00385918|FG002|Participant Flow|Baseline and Feasibility Testing|All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.
10865123|NCT00385918|OG000|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
10865124|NCT00385918|OG001|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
10865125|NCT00385918|OG000|Outcome|Lokomat Treatment|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
10865126|NCT00385918|EG000|Reported Event|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
10865127|NCT00385918|EG001|Reported Event|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.This group will switch to the 3-month robotic intervention after completing the home-based training program."
10865128|NCT00385944|BG000|Baseline|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
10865129|NCT00385944|BG001|Baseline|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
10865130|NCT00385944|BG002|Baseline|Total|Total of all reporting groups
10865131|NCT00385944|FG000|Participant Flow|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
10865132|NCT00385944|FG001|Participant Flow|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
10865133|NCT00385944|FG002|Participant Flow|Loading Dose|Clopidogrel 900-mg Loading Dose (a single or cumulative dose)
10865134|NCT00385944|OG000|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
10865135|NCT00385944|OG001|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
10865136|NCT00385944|OG000|Outcome|Clopidogrel 900 mg|Clopidogrel 900 mg LD (a single or cumulative dose)
10865137|NCT00385944|OG000|Outcome|Prasugrel/Clopidgrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
11126382|NCT01733069|BG000|Baseline|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
10865138|NCT00385944|OG001|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD)or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
10865139|NCT00385944|OG000|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
10865140|NCT00385944|OG001|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
10865141|NCT00385944|OG000|Outcome|Intent-to-treat Population|Both clopidogrel and prasugrel combined population
10865142|NCT00385944|EG000|Reported Event|Clopidogrel 900 mg LD|One time oral loading dose (LD) of 900-mg clopidogrel
10865143|NCT00385944|EG001|Reported Event|Prasugrel 10 mg - 1st MD|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days.
10865144|NCT00385944|EG002|Reported Event|Clopidogrel 150 mg - 1st MD|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days.
10865145|NCT00385944|EG003|Reported Event|Clopidogrel 150 mg - Crossover From Prasugrel 10 mg|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of prasugrel 10 mg and 100 mg aspirin during the 1st MD period.
10865146|NCT00385944|EG004|Reported Event|Prasugrel 10 mg - Crossover From Clopidogrel 150 mg|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of clopidogrel 150 mg and 100 mg aspirin during the 1st MD period.
10865147|NCT00385996|BG000|Baseline|Erlotinib|Erlotinib 150 mg po daily
10865148|NCT00385996|FG000|Participant Flow|Erlotinib|Erlotinib 150 mg po daily.
10865149|NCT00385996|OG000|Outcome|Erlotinib|Erlotinib 150 mg po daily
10865150|NCT00385996|OG000|Outcome|Erlotinib|"Erlotinib 150mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.~Tarceva (Erlotinib): Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH."
10865151|NCT00385996|EG000|Reported Event|Erlotinib|Erlotinib 150 mg po daily.
10865152|NCT00386009|BG000|Baseline|Placebo|placebo tablet taken by mouth once a day for 12 weeks
10865153|NCT00386009|BG001|Baseline|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
10865154|NCT00386009|BG002|Baseline|Total|Total of all reporting groups
10865155|NCT00386009|FG000|Participant Flow|Placebo|placebo tablet taken by mouth once a day for 12 weeks
10865156|NCT00386009|FG001|Participant Flow|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
10865157|NCT00386009|OG000|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
10865158|NCT00386009|OG001|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
11126383|NCT01733069|BG001|Baseline|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
10865159|NCT00386009|EG000|Reported Event|Placebo|placebo tablet taken by mouth once a day for 12 weeks
10865160|NCT00386009|EG001|Reported Event|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
10865161|NCT00386022|BG000|Baseline|Younger PMW|"Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
10865162|NCT00386022|BG001|Baseline|Older PMW|"Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
10865163|NCT00386022|BG002|Baseline|Total|Total of all reporting groups
10865164|NCT00386022|FG000|Participant Flow|Younger PMW|"Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
10865165|NCT00386022|FG001|Participant Flow|Older PMW|"Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
10865166|NCT00386022|OG000|Outcome|Younger PMW|"Postmenopausal women aged 45-55 years studied at baseline using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
10865167|NCT00386022|OG001|Outcome|Older PMW|"Postmenopausal women aged 70-80 years studied at baseline using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
10865168|NCT00386022|OG000|Outcome|Young Postmenopausal Women|"Postmenopausal women aged 45-55 years studied after 1 month of transdermal estrogen 0.05 mg/day using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
10865169|NCT00386022|OG001|Outcome|Older Postmenopausal Women|"Postmenopausal women aged 70-80 years studied after 1 month of transdermal estrogen 0.05 mg/day using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
10865170|NCT00386022|EG000|Reported Event|Younger PMW|"Postmenopausal women aged 45-55 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
10865171|NCT00386022|EG001|Reported Event|Older PMW|"Postmenopausal women aged 70-80 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
10865172|NCT00386100|BG000|Baseline|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
10865173|NCT00386100|BG001|Baseline|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
10865174|NCT00386100|BG002|Baseline|Total|Total of all reporting groups
10865175|NCT00386100|FG000|Participant Flow|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
10865176|NCT00386100|FG001|Participant Flow|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
10865177|NCT00386100|OG000|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
10865178|NCT00386100|OG001|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
10865179|NCT00386100|EG000|Reported Event|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
10865180|NCT00386100|EG001|Reported Event|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
10865181|NCT00386152|BG000|Baseline|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
10865182|NCT00386152|BG001|Baseline|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
10865183|NCT00386152|BG002|Baseline|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
10865184|NCT00386152|BG003|Baseline|Total|Total of all reporting groups
10865185|NCT00386152|FG000|Participant Flow|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
10865186|NCT00386152|FG001|Participant Flow|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
10865187|NCT00386152|FG002|Participant Flow|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
10865188|NCT00386152|OG000|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
11126384|NCT01733069|BG002|Baseline|Total|Total of all reporting groups
10865189|NCT00386152|OG001|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
10865190|NCT00386152|OG002|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
10865191|NCT00386152|EG000|Reported Event|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
10865192|NCT00386152|EG001|Reported Event|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
10865193|NCT00386152|EG002|Reported Event|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
10865194|NCT00386243|BG000|Baseline|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
10865195|NCT00386243|BG001|Baseline|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
10865196|NCT00386243|BG002|Baseline|Total|Total of all reporting groups
10865197|NCT00386243|FG000|Participant Flow|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
10865198|NCT00386243|FG001|Participant Flow|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
10865199|NCT00386243|OG000|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
10865200|NCT00386243|OG001|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
10865201|NCT00386243|EG000|Reported Event|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
10865202|NCT00386243|EG001|Reported Event|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
10865203|NCT00386256|BG000|Baseline|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
10865204|NCT00386256|BG001|Baseline|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
10865205|NCT00386256|BG002|Baseline|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
10865206|NCT00386256|BG003|Baseline|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
10865207|NCT00386256|BG004|Baseline|Total|Total of all reporting groups
10865208|NCT00386256|FG000|Participant Flow|Health Buddy Outpatient|Health Buddy(R), Home telehealth technology : Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.
10865209|NCT00386256|FG001|Participant Flow|Telephone Outpatient|
10865210|NCT00386256|FG002|Participant Flow|Health Buddy Inpatient|
10865211|NCT00386256|FG003|Participant Flow|Telephone Inpatient|
10865212|NCT00386256|OG000|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
10865213|NCT00386256|OG001|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
10865214|NCT00386256|OG002|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
10865215|NCT00386256|OG003|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
10865216|NCT00386256|EG000|Reported Event|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
10865217|NCT00386256|EG001|Reported Event|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
10865218|NCT00386256|EG002|Reported Event|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
10865219|NCT00386256|EG003|Reported Event|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
10865220|NCT00386308|BG000|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10865221|NCT00386308|BG001|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10865222|NCT00386308|BG002|Baseline|Total|Total of all reporting groups
10865223|NCT00386308|FG000|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10865224|NCT00386308|FG001|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10865225|NCT00386308|OG000|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10865226|NCT00386308|OG001|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10865227|NCT00386308|EG000|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10865228|NCT00386308|EG001|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10865229|NCT00386334|BG000|Baseline|Placebo|Placebo tablets
10865230|NCT00386334|BG001|Baseline|Eszopiclone|Eszopiclone 2 mg tablets
10865231|NCT00386334|BG002|Baseline|Total|Total of all reporting groups
10865232|NCT00386334|FG000|Participant Flow|Placebo|Placebo tablets
10865233|NCT00386334|FG001|Participant Flow|Eszopiclone|Eszopiclone 2 mg tablets
10865234|NCT00386334|OG000|Outcome|Placebo|Placebo tablets
10865235|NCT00386334|OG001|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
10865236|NCT00386334|EG000|Reported Event|Placebo|Placebo tablets
10865237|NCT00386334|EG001|Reported Event|Eszopiclone|Eszopiclone 2 mg tablets
10865238|NCT00386360|BG000|Baseline|Placebo|Placebo, 1 tablet weekly on the same day
10865239|NCT00386360|BG001|Baseline|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
10865240|NCT00386360|BG002|Baseline|Total|Total of all reporting groups
10865241|NCT00386360|FG000|Participant Flow|Placebo|Placebo, 1 tablet weekly on the same day
10865242|NCT00386360|FG001|Participant Flow|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
10865243|NCT00386360|OG000|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
10865244|NCT00386360|OG001|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
10865245|NCT00386360|EG000|Reported Event|Placebo|Placebo, 1 tablet weekly on the same day
10865246|NCT00386360|EG001|Reported Event|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
10865247|NCT00386425|BG000|Baseline|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
10865248|NCT00386425|BG001|Baseline|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
10865249|NCT00386425|BG002|Baseline|Randomized Non-ITT Population|
10865250|NCT00386425|BG003|Baseline|Total|Total of all reporting groups
10865251|NCT00386425|FG000|Participant Flow|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
10865252|NCT00386425|FG001|Participant Flow|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
10865253|NCT00386425|FG002|Participant Flow|Randomized Non-ITT Population|Participants were randomized to either the Standard or Alternative Therapy and received 24 mcg/kg/hr during the first 24 hours (common therapy period); however, they did not continue on to receive the actual randomized therapy.
10865254|NCT00386425|OG000|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
10865255|NCT00386425|OG001|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
10865256|NCT00386425|OG000|Outcome|Standard Therapy - Severe Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
10865257|NCT00386425|OG001|Outcome|Standard Therapy - Moderate Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
10865258|NCT00386425|OG002|Outcome|Alternative Therapy - Severe Deficiency|Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
10865259|NCT00386425|OG003|Outcome|Alternative Therapy - Moderate Deficiency|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
10865260|NCT00386425|OG000|Outcome|Normalized Protein C|
10865261|NCT00386425|OG001|Outcome|Did Not Normalize Protein C|
10865262|NCT00386425|EG000|Reported Event|Standard Therapy|Participants assigned to standard therapy (24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours) who received any amount of study drug.
10865263|NCT00386425|EG001|Reported Event|Alternative Therapy|Participants assigned to alternative therapy (Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours) who received any amount of study drug.
10865264|NCT00386477|BG000|Baseline|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
10865265|NCT00386477|BG001|Baseline|Control|No vaginal cleansing or sham wash performed.
10865266|NCT00386477|BG002|Baseline|Total|Total of all reporting groups
10865267|NCT00386477|FG000|Participant Flow|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
10865268|NCT00386477|FG001|Participant Flow|Control|No vaginal cleansing or sham wash performed.
10865269|NCT00386477|OG000|Outcome|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
10865270|NCT00386477|OG001|Outcome|Control|No vaginal cleansing or sham wash performed.
10865271|NCT00386477|EG000|Reported Event|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
10865272|NCT00386477|EG001|Reported Event|Control|No vaginal cleansing or sham wash performed.
10865273|NCT00386607|BG000|Baseline|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
10865274|NCT00386607|FG000|Participant Flow|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
10865275|NCT00386607|FG001|Participant Flow|Extension Treatment|"For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.~Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.~The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits."
10865276|NCT00386607|OG000|Outcome|Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
10865277|NCT00386607|OG000|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
10865278|NCT00386607|OG000|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
10865279|NCT00386607|OG000|Outcome|Core and Extension Treatment - Aliskiren/Valsartan/HCTZ|All patients receiving aliskiren / valsartan / HCTZ during either core or extension study.
10865280|NCT00386607|EG000|Reported Event|Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone|Core Period: Aliskiren 150 mg /Valsartan 160 mg alone
10865281|NCT00386607|EG001|Reported Event|Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone|Core Period: Aliskiren 300 mg /Valsartan 320 mg alone
10865282|NCT00386607|EG002|Reported Event|Core Period: Aliskiren / Valsartan|Core Period: Aliskiren/Valsartan
10865283|NCT00386607|EG003|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
10865284|NCT00386607|EG004|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg|Core and Extension: Aliskiren/Valsartan/HCTZ 25 mg
10865285|NCT00386607|EG005|Reported Event|Core and Extension: Total|Core and Extension: Total includes all study patients, treated with Aliskiren/Valsartan or Aliskiren//valsartan/HCTZ during core or extension.
10865286|NCT00386776|BG000|Baseline|Experimental|The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
10865287|NCT00386776|FG000|Participant Flow|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules- family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
10865288|NCT00386776|OG000|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules- family history, social history, cardiac history, pulmonary history, and the like.
10865289|NCT00386776|OG000|Outcome|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules- family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
10865290|NCT00386776|OG000|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules- family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
10865291|NCT00386776|EG000|Reported Event|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules- family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
10865292|NCT00386880|BG000|Baseline|Subjects With Episodic Migraine|Subjects with less than 8 distict migraine episodes per month.
10865293|NCT00386880|FG000|Participant Flow|Subjects With Episodic Migraine With Allodynia|These are the subjects with episodic migraine with allodynia.
10865294|NCT00386880|FG001|Participant Flow|Subjects With Episodic Migraine Without Allodynia|These are the subjects with episodic migraine without allodynia.
10865295|NCT00386880|OG000|Outcome|Subjects With Episodic Migraine With Allodynia|These are subjects with episodic migraine with allodynia
10865296|NCT00386880|OG001|Outcome|Subjects With Episodic Migraine Without Allodynia|These are subjects with episodic migraine without allodynia
10865297|NCT00386880|EG000|Reported Event|Subjects With Episodic Migraine|
10865298|NCT00387010|BG000|Baseline|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
10865299|NCT00387010|FG000|Participant Flow|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
10865300|NCT00387010|OG000|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
10865301|NCT00387010|EG000|Reported Event|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
10865302|NCT00387023|BG000|Baseline|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
10865303|NCT00387023|FG000|Participant Flow|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
10865304|NCT00387023|OG000|Outcome|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
10865305|NCT00387023|EG000|Reported Event|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
10865306|NCT00387036|BG000|Baseline|Entire Study Population|
10865307|NCT00387036|FG000|Participant Flow|Fluticasone Propionate Then Placebo|Following 1 week Placebo run-in period (Period I), patients were randomized to receive fluticasone propionate 250 mcg Hydrofluoroalkane (HFA) 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week placebo 2 inhalations twice daily (Period IV).
10865308|NCT00387036|FG001|Participant Flow|Placebo Then Fluticasone Propionate|Following 1 week Placebo run-in period (Period I), patients were randomized to receive placebo 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week fluticasone propionate 250 mcg HFA 2 inhalations twice daily (Period IV).
10865309|NCT00387036|OG000|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
10865310|NCT00387036|OG001|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
10865311|NCT00387036|EG000|Reported Event|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
11223132|NCT02351167|BG000|Baseline|Combination NRT and Counseling|Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
10865312|NCT00387036|EG001|Reported Event|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
10865313|NCT00387088|BG000|Baseline|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
10865314|NCT00387088|BG001|Baseline|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
10865315|NCT00387088|BG002|Baseline|Total|Total of all reporting groups
10865316|NCT00387088|FG000|Participant Flow|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
10865317|NCT00387088|FG001|Participant Flow|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
10865318|NCT00387088|OG000|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
10865319|NCT00387088|OG001|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
10865320|NCT00387088|EG000|Reported Event|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
10865321|NCT00387088|EG001|Reported Event|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
10865322|NCT00387127|BG000|Baseline|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
10865323|NCT00387127|BG001|Baseline|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
10865324|NCT00387127|BG002|Baseline|Total|Total of all reporting groups
10865325|NCT00387127|FG000|Participant Flow|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
10865326|NCT00387127|FG001|Participant Flow|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
10977082|NCT00943592|FG000|Participant Flow|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
11223133|NCT02351167|BG001|Baseline|Varenicline (Chantix) and Counseling|Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
10865327|NCT00387127|OG000|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
10865328|NCT00387127|OG001|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction &lt;2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
10865329|NCT00387127|OG001|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
10865330|NCT00387127|OG001|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
10865331|NCT00387127|EG000|Reported Event|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
10865332|NCT00387127|EG001|Reported Event|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
10865333|NCT00387153|BG000|Baseline|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
10865334|NCT00387153|FG000|Participant Flow|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
10865335|NCT00387153|OG000|Outcome|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
10865336|NCT00387153|EG000|Reported Event|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
10865337|NCT00387335|BG000|Baseline|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
10865338|NCT00387335|BG001|Baseline|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
10865339|NCT00387335|BG002|Baseline|Total|Total of all reporting groups
10865340|NCT00387335|FG000|Participant Flow|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
10865341|NCT00387335|FG001|Participant Flow|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.ECOG Performance Status 2.
10865342|NCT00387335|OG000|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
10865343|NCT00387335|OG001|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
10865344|NCT00387335|EG000|Reported Event|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
10865345|NCT00387335|EG001|Reported Event|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
10865346|NCT00387348|BG000|Baseline|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
10865347|NCT00387348|BG001|Baseline|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
10865348|NCT00387348|BG002|Baseline|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
10865349|NCT00387348|BG003|Baseline|Total|Total of all reporting groups
10865350|NCT00387348|FG000|Participant Flow|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks.
10865351|NCT00387348|FG001|Participant Flow|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
10865352|NCT00387348|FG002|Participant Flow|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
10865353|NCT00387348|OG000|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks
10865354|NCT00387348|OG001|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
10865355|NCT00387348|OG002|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
10865356|NCT00387348|OG000|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
10865357|NCT00387348|OG001|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
10865358|NCT00387348|OG002|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
10865359|NCT00387348|OG000|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
10865360|NCT00387348|OG002|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
10865361|NCT00387348|EG000|Reported Event|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
10865362|NCT00387348|EG001|Reported Event|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
10865363|NCT00387348|EG002|Reported Event|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
10865364|NCT00387426|BG000|Baseline|Sunitinib|37.5 mg orally daily for 6-week cycle
10865365|NCT00387426|FG000|Participant Flow|Sunitinib|37.5 mg orally daily for 6-week cycle
10865366|NCT00387426|OG000|Outcome|Sunitinib|37.5 mg orally daily for 6-week cycle
11223134|NCT02351167|BG002|Baseline|Placebo Medicine and Counseling|Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
10865367|NCT00387426|EG000|Reported Event|Sunitinib|37.5 mg orally daily for 6-week cycle
10865368|NCT00387465|BG000|Baseline|Phase II Arm|Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10865369|NCT00387465|BG001|Baseline|Phase I - 30mg/m2 Azacitidine|Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
10865370|NCT00387465|BG002|Baseline|Phase I - 40mg/m2 Azacitidine|Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
10865371|NCT00387465|BG003|Baseline|Total|Total of all reporting groups
10865372|NCT00387465|FG000|Participant Flow|Phase I - 30mg/m2 Azacitidine|Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
10865373|NCT00387465|FG001|Participant Flow|Phase I - 40mg/m2 Azacitidine|Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
10865374|NCT00387465|FG002|Participant Flow|Phase II Arm|Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10865375|NCT00387465|OG000|Outcome|Phase II Arm|Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10865376|NCT00387465|OG001|Outcome|Phase I - 30mg/m2 Azacitidine|Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
10865377|NCT00387465|OG002|Outcome|Phase I - 40mg/m2 Azacitidine|Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
10865378|NCT00387465|OG000|Outcome|Azacitidine 40mg/m2 With Entinostat|Patients receive azacitidine 40mg/m2 SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10865379|NCT00387465|EG000|Reported Event|Azacitidine 40mg/m2 and Entinostat|Patients from both Phase I and II who received azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10865380|NCT00387465|EG001|Reported Event|Phase I - 30mg/m2 Azacitidine|Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
10865381|NCT00387621|BG000|Baseline|Control Group (Normals)|Healthy volunteers without heart disease
10865382|NCT00387621|BG001|Baseline|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
10865383|NCT00387621|BG002|Baseline|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
10865384|NCT00387621|BG003|Baseline|Total|Total of all reporting groups
10865385|NCT00387621|FG000|Participant Flow|Placebo First, Then Nesiritide (Arm A)|In the first intervention period the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
10865386|NCT00387621|FG001|Participant Flow|Nesiritide First, Then Placebo (Arm B)|In the first intervention period the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
10865387|NCT00387621|OG000|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
10865388|NCT00387621|OG000|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) and Nesiritide First, then Placebo (Arm B).
10865389|NCT00387621|OG000|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
10865390|NCT00387621|OG001|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
10865391|NCT00387621|OG002|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
10865392|NCT00387621|OG000|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
10865393|NCT00387621|OG001|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
10865394|NCT00387621|OG002|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
10865395|NCT00387621|EG000|Reported Event|Placebo|The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. As this was a cross over study, all participants received placebo and nesiritide.
10865396|NCT00387621|EG001|Reported Event|Nesiritide|The first 10 subjects in each group received a dose of 5 ug/kg and the next 10 subjects received a dose of 10 ug/kg. As this was a cross over study, all participants received placebo and nesiritide.
10865397|NCT00387647|BG000|Baseline|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
10865398|NCT00387647|FG000|Participant Flow|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
10865399|NCT00387647|OG000|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
10865400|NCT00387647|EG000|Reported Event|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
10865401|NCT00387660|BG000|Baseline|Arm A|Metastatic small cell lung cancer with no previous chemotherapy
10865402|NCT00387660|BG001|Baseline|Arm B|Relapsed small cell lung cancer with previous chemotherapy
10865403|NCT00387660|BG002|Baseline|Total|Total of all reporting groups
10865404|NCT00387660|FG000|Participant Flow|Arm A - Metastatic SCLC (no Previous Chemo)|Extensive small cell lung cancer with no previous chemotherapy
10865405|NCT00387660|FG001|Participant Flow|Arm B - Relapsed SCLC (Previous Chemo)|Relapsed small cell lung cancer with previous chemotherapy
10865406|NCT00387660|OG000|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
10865407|NCT00387660|OG001|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
10865408|NCT00387660|EG000|Reported Event|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
10865409|NCT00387660|EG001|Reported Event|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
10865410|NCT00387712|BG000|Baseline|Velocity Based Treadmill Training|6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
10865411|NCT00387712|BG001|Baseline|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
10865412|NCT00387712|BG002|Baseline|Total|Total of all reporting groups
10865413|NCT00387712|FG000|Participant Flow|Velocity Based Treadmill Training|6-month treadmill exercise progressed on speed based on individual participant's tolerance, abilities and safety.
11223135|NCT02351167|BG003|Baseline|Total|Total of all reporting groups
10865414|NCT00387712|FG001|Participant Flow|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
10865415|NCT00387712|OG000|Outcome|Velocity Based Treadmill Training|6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
10865416|NCT00387712|OG001|Outcome|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
10865417|NCT00387712|EG000|Reported Event|Velocity Based Treadmill Training|6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
10865418|NCT00387712|EG001|Reported Event|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
10865419|NCT00387725|BG000|Baseline|Twinrix|Given on a 0, 1-, 6- month schedule
10865420|NCT00387725|BG001|Baseline|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
10865421|NCT00387725|BG002|Baseline|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
10865422|NCT00387725|BG003|Baseline|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
10865423|NCT00387725|BG004|Baseline|Total|Total of all reporting groups
10865424|NCT00387725|FG000|Participant Flow|Twinrix|Given on a 0, 1-, 6- month schedule
10865425|NCT00387725|FG001|Participant Flow|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
10865426|NCT00387725|FG002|Participant Flow|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
10865427|NCT00387725|FG003|Participant Flow|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
10865428|NCT00387725|OG000|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
10865429|NCT00387725|OG001|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
10865430|NCT00387725|OG002|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
10865431|NCT00387725|OG003|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
10865432|NCT00387725|EG000|Reported Event|Twinrix|Given on a 0, 1-, 6- month schedule
10865433|NCT00387725|EG001|Reported Event|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
10865434|NCT00387725|EG002|Reported Event|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
10865435|NCT00387725|EG003|Reported Event|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
10865436|NCT00387751|BG000|Baseline|Bevacizumab and Sorafenib|
10865437|NCT00387751|FG000|Participant Flow|Bevacizumab and Sorafenib|
10865438|NCT00387751|OG000|Outcome|Bevacizumab and Sorafenib|"Bevacizumab was administered as a 5 mg/kg intravenous dose every 2 weeks. The dose was based on the patient's actual body weight; the dose recalculated if there was a weight change of >10% from baseline.~Sorafenib was administered as a 200 mg oral dose twice daily, for 5 days every 7 days. Courses will be defined as 28-day treatment periods and will be repeated without interruption until development of progressive disease or development of serious drug related toxicities."
10865439|NCT00387751|OG000|Outcome|Safety and Tolerability|No data collected
10865440|NCT00387751|OG000|Outcome|Survival|No data collected
10865441|NCT00387751|EG000|Reported Event|Bevacizumab and Sorafenib|
10865442|NCT00387764|BG000|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
10865443|NCT00387764|FG000|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
10865444|NCT00387764|OG000|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
10865445|NCT00387764|EG000|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
10865446|NCT00387790|BG000|Baseline|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
10865447|NCT00387790|FG000|Participant Flow|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
10865448|NCT00387790|OG000|Outcome|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
10865449|NCT00387790|EG000|Reported Event|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
10879139|NCT00455689|OG001|Outcome|Did Not Develop Hot Flashes|"Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)~Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection~Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women."
10879140|NCT00455689|EG000|Reported Event|All Subjects|20 subjects who all received one leuprolide injection
10879141|NCT00455702|BG000|Baseline|D-cycloserine|50 mg d-cycloserine
10865450|NCT00387829|BG000|Baseline|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
10865451|NCT00387829|BG001|Baseline|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
10865452|NCT00387829|BG002|Baseline|Total|Total of all reporting groups
10865453|NCT00387829|FG000|Participant Flow|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
10865454|NCT00387829|FG001|Participant Flow|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
10865455|NCT00387829|OG000|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
10865456|NCT00387829|OG001|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
10865457|NCT00387829|EG000|Reported Event|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
10865458|NCT00387829|EG001|Reported Event|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
10865459|NCT00387881|BG000|Baseline|Placebo|Baseline Characteristics used the Safety Population. Not the Randomised Population
10865460|NCT00387881|BG001|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population
10865461|NCT00387881|BG002|Baseline|Total|Total of all reporting groups
10865462|NCT00387881|FG000|Participant Flow|Placebo|
10865463|NCT00387881|FG001|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
10865464|NCT00387881|OG000|Outcome|Placebo|
10865465|NCT00387881|OG001|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
10865466|NCT00387881|EG000|Reported Event|Placebo|
10865467|NCT00387881|EG001|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
10865468|NCT00387894|BG000|Baseline|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
10865469|NCT00387894|FG000|Participant Flow|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|Tarceva self-administered in an open-label, unblinded manner to all patients enrolled. During the treatment period, patients who are not receiving enzyme-inducing antiepileptic drugs (EIAED) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days from 150 to 200 mg/day or from 600 to 650 mg/day assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
10865470|NCT00387894|OG000|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
10865471|NCT00387894|EG000|Reported Event|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
10865472|NCT00387959|BG000|Baseline|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
10865473|NCT00387959|FG000|Participant Flow|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
10865474|NCT00387959|OG000|Outcome|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
10865475|NCT00387959|EG000|Reported Event|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
10865476|NCT00388037|BG000|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
10865477|NCT00388037|FG000|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
10865478|NCT00388037|OG000|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
10865479|NCT00388037|EG000|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
10865480|NCT00388154|BG000|Baseline|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
10865481|NCT00388154|FG000|Participant Flow|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
10865482|NCT00388154|OG000|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
10865483|NCT00388154|EG000|Reported Event|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
10865484|NCT00388297|BG000|Baseline|Levothyroxine for Subclinical Hypothyroidism|"Levothyroxine~Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery."
10865485|NCT00388297|BG001|Baseline|Placebo for Levothyroxine - Subclinical Hypothyroidism|Placebo for Levothyroxine for the Subclinical Hypothyroidism
10865486|NCT00388297|BG002|Baseline|Levothyroxine for Hypothyroxinemia|"Levothyroxine~Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery."
10865487|NCT00388297|BG003|Baseline|Placebo for Levothyroxine - Hypothyroxinemia|Placebo for Levothyroxine for the Hypothyroxinemia
10865488|NCT00388297|BG004|Baseline|Total|Total of all reporting groups
10865489|NCT00388297|FG000|Participant Flow|Levothyroxine for Subclinical Hypothyroidism|"Levothyroxine~Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery."
10865490|NCT00388297|FG001|Participant Flow|Placebo for Levothyroxine - Subclinical Hypothyroidism|Placebo for Levothyroxine for the Subclinical Hypothyroidism group
10865491|NCT00388297|FG002|Participant Flow|Levothyroxine for Hypothyroxinemia|"Levothyroxine~Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery."
10865492|NCT00388297|FG003|Participant Flow|Placebo for Levothyroxine for Hypothyroxinemia|Placebo for Levothyroxine for the Hypothyroxinemia group
10865493|NCT00388297|OG000|Outcome|Levothyroxine for Subclinical Hypothyroidism|"Levothyroxine~Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery."
10865494|NCT00388297|OG001|Outcome|Placebo for Levothyroxine - Subclinical Hypothyroidism|Placebo for Levothyroxine for the Subclinical Hypothyroidism
10865495|NCT00388297|OG002|Outcome|Levothyroxine for Hypothyroxinemia|"Levothyroxine~Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery."
10865496|NCT00388297|OG003|Outcome|Placebo for Levothyroxine - Hypothyroxinemia|Placebo for Levothyroxine for the Hypothyroxinemia
10865497|NCT00388297|EG000|Reported Event|Levothyroxine for Subclinical Hypothyroidism|"100 µg of Levothryoxine for participants with subclinical hypothyroidism~Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery."
10865498|NCT00388297|EG001|Reported Event|Placebo for Levothyroxine - Subclinincal Hypothyroidism|"Placebo for Levothyroxine for participants with subclinical hypothyroidism~Placebo for Levothyroxine"
10865499|NCT00388297|EG002|Reported Event|Levothyroxine for Hypothyroxinemia - Hypothyroxinemia|"50 µg of Levothyroxine for participants with hypothyroxinemia~Levothyroxine: Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery."
10865500|NCT00388297|EG003|Reported Event|Placebo for Levothyroxine|"Placebo for Levothyroxine for participants with hypothyroxinemia~Placebo for Levothyroxine"
10865501|NCT00388349|BG000|Baseline|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10865502|NCT00388349|FG000|Participant Flow|1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10865503|NCT00388349|FG001|Participant Flow|1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10879142|NCT00455702|BG001|Baseline|Placebo|50 mg placebo
10879143|NCT00455702|BG002|Baseline|Total|Total of all reporting groups
10879144|NCT00455702|FG000|Participant Flow|D-cycloserine|50 mg d-cycloserine
10865504|NCT00388349|OG000|Outcome|1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10865505|NCT00388349|OG001|Outcome|1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10865506|NCT00388349|OG000|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10865507|NCT00388349|OG000|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10865508|NCT00388349|OG000|Outcome|1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine 1250 mg/m2 administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10865509|NCT00388349|EG000|Reported Event|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
10865510|NCT00388362|BG000|Baseline|Sirolimus|Administration of Sirolimus and Prednisone
10865511|NCT00388362|FG000|Participant Flow|Sirolimus Therapy|Administration of Sirolimus and Prednisone
10865512|NCT00388362|OG000|Outcome|Sirolimus Therapy|Administration of Sirolimus and Prednisone
10865513|NCT00388362|EG000|Reported Event|Sirolimus Therapy|Administration of Sirolimus and Prednisone
10865514|NCT00388414|BG000|Baseline|Placebo Then Duloxetine|In the first 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. Following a -week washout period, in the second 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week).
10865515|NCT00388414|BG001|Baseline|Duloxetine Then Placebo|In the first 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). Following a -week washout period, in the second 8-week treatment period, participants received placebo to match duloxetine for 8 weeks.
10865516|NCT00388414|BG002|Baseline|Total|Total of all reporting groups
10865517|NCT00388414|FG000|Participant Flow|Placebo Then Duloxetine|In the first 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. Following a -week washout period, in the second 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week).
10865518|NCT00388414|FG001|Participant Flow|Duloxetine Then Placebo|In the first 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). Following a -week washout period, in the second 8-week treatment period, participants received placebo to match duloxetine for 8 weeks.
10865519|NCT00388414|OG000|Outcome|Placebo - Sugar Pill|Placebo: Placebo pill once daily
10865520|NCT00388414|OG001|Outcome|Duloxetine|duloxetine: 30-60mg of duloxetine daily
10865521|NCT00388414|OG000|Outcome|Baseline|Pre-treatment
10865522|NCT00388414|OG001|Outcome|Placebo - Sugar Pill|Placebo: Placebo pill once daily
10865523|NCT00388414|OG002|Outcome|Duloxetine|duloxetine: 30-60mg of duloxetine daily
10865524|NCT00388414|EG000|Reported Event|All Participants|"Includes all participants.~Placebo: Placebo pill once daily Duloxetine: 30-60mg of duloxetine daily"
10865525|NCT00388453|BG000|Baseline|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
10865526|NCT00388453|BG001|Baseline|Volunteers With Gastroesophageal Reflux Disaese (GERD)|History of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy
10865527|NCT00388453|BG002|Baseline|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing,and hoarseness.
10865528|NCT00388453|BG003|Baseline|Total|Total of all reporting groups
10865529|NCT00388453|FG000|Participant Flow|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
10865530|NCT00388453|FG001|Participant Flow|Volunteers With History of Gastroesophageal Reflux Disease|Patients with a history of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of their symptoms with PPI use and if they had erosive esophagitis by Los Angeles classification at endoscopy.
10865531|NCT00388453|FG002|Participant Flow|Volunteers With Laryngopharangeal Reflux (LPR)|Patients suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing and hoarseness. This group included non-smokers with unremarkable chest radiographs who had undergone extensive testing and exclusion of other common causes for their laryngeal symptoms by the Vanderbilt Allergy, Sinus and Asthma Program (ASAP), and Vanderbilt Voice Center (spirometry, methacholine challenge, sputum eosinophil count, otolaryngology exam, high-resolution computerized tomography scan of the thorax and sinuses and sinus testing).
10865532|NCT00388453|OG000|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
10879145|NCT00455702|FG001|Participant Flow|Placebo|50 mg placebo
10865533|NCT00388453|OG001|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
10865534|NCT00388453|OG002|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
10865535|NCT00388453|EG000|Reported Event|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
10865536|NCT00388453|EG001|Reported Event|Volunteers With Gastroesphageal Reflux Disease (GERD)|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at time of endoscopy.
10865537|NCT00388453|EG002|Reported Event|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
10865538|NCT00388505|BG000|Baseline|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
10865539|NCT00388505|BG001|Baseline|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
10865540|NCT00388505|BG002|Baseline|Total|Total of all reporting groups
10865541|NCT00388505|FG000|Participant Flow|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
10865542|NCT00388505|FG001|Participant Flow|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
10865543|NCT00388505|OG000|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
10865544|NCT00388505|OG001|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
10865545|NCT00388505|EG000|Reported Event|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
10865546|NCT00388505|EG001|Reported Event|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
10865547|NCT00388583|BG000|Baseline|Fluzone ID Vaccine Group|Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0.
10865548|NCT00388583|BG001|Baseline|Fluzone IM Vaccine Group|Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0.
10865549|NCT00388583|BG002|Baseline|Total|Total of all reporting groups
10865550|NCT00388583|FG000|Participant Flow|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
10865551|NCT00388583|FG001|Participant Flow|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
10865552|NCT00388583|OG000|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
10865553|NCT00388583|OG001|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
10865554|NCT00388583|EG000|Reported Event|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
10865555|NCT00388583|EG001|Reported Event|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
10865556|NCT00388674|BG000|Baseline|Entecavir (ETV)|Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.
10865557|NCT00388674|BG001|Baseline|Other Anti-HBV Medication (Non-ETV)|Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
10865558|NCT00388674|BG002|Baseline|Total|Total of all reporting groups
10865559|NCT00388674|FG000|Participant Flow|Entecavir (ETV)|Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.
10865560|NCT00388674|FG001|Participant Flow|Other Anti-HBV Medication (Non-ETV)|Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
10865561|NCT00388674|OG000|Outcome|Entecavir (ETV)|Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.
10865562|NCT00388674|OG001|Outcome|Other Anti-HBV Medication (Non-ETV)|Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
10865563|NCT00388674|EG000|Reported Event|Entecavir (ETV)|Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily.
10865564|NCT00388674|EG001|Reported Event|Other Anti-HBV Medication (Non-ETV)|Standard of care HBV Nucleoside/Nucleotide Monotherapy, specific agent selected at the discretion of the investigator
10865565|NCT00388726|BG000|Baseline|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
10865566|NCT00388726|BG001|Baseline|Treatment of Physician's Choice|Treatment of Physician's Choice
10865567|NCT00388726|BG002|Baseline|Total|Total of all reporting groups
10865568|NCT00388726|FG000|Participant Flow|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
10865569|NCT00388726|FG001|Participant Flow|Treatment of Physician's Choice|Treatment of Physician's Choice
10865570|NCT00388726|OG000|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
10865571|NCT00388726|OG001|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
10865572|NCT00388726|EG000|Reported Event|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
10865573|NCT00388726|EG001|Reported Event|Treatment of Physician's Choice|Treatment of Physician's Choice
10865574|NCT00388804|BG000|Baseline|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
10865575|NCT00388804|BG001|Baseline|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
10865576|NCT00388804|BG002|Baseline|Total|Total of all reporting groups
10865577|NCT00388804|FG000|Participant Flow|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
10865578|NCT00388804|FG001|Participant Flow|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
10865579|NCT00388804|OG000|Outcome|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
10865580|NCT00388804|OG001|Outcome|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
10865581|NCT00388804|EG000|Reported Event|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
10865582|NCT00388804|EG001|Reported Event|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
10865583|NCT00388947|BG000|Baseline|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
10865584|NCT00388947|FG000|Participant Flow|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
10865585|NCT00388947|OG000|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
10865586|NCT00388947|EG000|Reported Event|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
10865587|NCT00388973|BG000|Baseline|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
10865588|NCT00388973|BG001|Baseline|Placebo|Placebo
10865589|NCT00388973|BG002|Baseline|Total|Total of all reporting groups
10865590|NCT00388973|FG000|Participant Flow|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
10865591|NCT00388973|FG001|Participant Flow|Placebo|Placebo
10865592|NCT00388973|OG000|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
10865593|NCT00388973|OG001|Outcome|Placebo|Placebo
10865594|NCT00388973|EG000|Reported Event|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
10865595|NCT00388973|EG001|Reported Event|Placebo|Placebo
10865596|NCT00389064|BG000|Baseline|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
10865597|NCT00389064|BG001|Baseline|Placebo|
10865598|NCT00389064|BG002|Baseline|Total|Total of all reporting groups
10865599|NCT00389064|FG000|Participant Flow|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
10865600|NCT00389064|FG001|Participant Flow|Placebo|
10865601|NCT00389064|OG000|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
10865602|NCT00389064|OG001|Outcome|Placebo|
10865603|NCT00389064|EG000|Reported Event|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
10865604|NCT00389064|EG001|Reported Event|Placebo|
10865605|NCT00389168|BG000|Baseline|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
10865606|NCT00389168|BG001|Baseline|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
10865607|NCT00389168|BG002|Baseline|Total|Total of all reporting groups
10865608|NCT00389168|FG000|Participant Flow|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
10865609|NCT00389168|FG001|Participant Flow|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
10865610|NCT00389168|OG000|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
10865611|NCT00389168|OG001|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
10865612|NCT00389168|EG000|Reported Event|Irbesratan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
10865613|NCT00389168|EG001|Reported Event|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
10865614|NCT00389207|BG000|Baseline|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
10865615|NCT00389207|BG001|Baseline|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
10865616|NCT00389207|BG002|Baseline|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
10865617|NCT00389207|BG003|Baseline|Total|Total of all reporting groups
10865618|NCT00389207|FG000|Participant Flow|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
10865619|NCT00389207|FG001|Participant Flow|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
10865620|NCT00389207|FG002|Participant Flow|Atazanvir/Ritonavir|Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®
10865621|NCT00389207|OG000|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
10865622|NCT00389207|OG001|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
10865623|NCT00389207|OG002|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
10865624|NCT00389207|OG003|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
10865625|NCT00389207|OG000|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
10865626|NCT00389207|OG001|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
10865627|NCT00389207|OG000|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
10865628|NCT00389207|OG002|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
10865629|NCT00389207|EG000|Reported Event|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
11223136|NCT02351167|FG000|Participant Flow|Combination NRT and Counseling|Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
10865630|NCT00389207|EG001|Reported Event|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
10865631|NCT00389207|EG002|Reported Event|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
10865632|NCT00389324|BG000|Baseline|Safety Population|The safety population included all subjects who received any amount of study medication (IGIV-C) via intravenous (IV) and/or subcutaneous (SC) routes of administration. As such, the safety population included all study participants combined (who received any dose), whether they entered the study in the Run-In or Intravenous Phase.
10865633|NCT00389324|FG000|Participant Flow|IGIV-C|"21 subjects were required to enter a Run-In Phase (3 to 4 months) and received IGIV-C between 200 and 600 mg/kg by intravenous infusion every 3 or 4 weeks. 18 subjects completed the Run-In Phase and entered the Intravenous Phase.~A total of 32 subjects entered the IV Phase: 14 subjects who had received IV IGIV-C prior to screening directly entered the IV Phase and 18 subjects who had completed the Run-in Phase continued in the study to enter the IV Phase. Subjects in the IV Phase received two IV infusions at the same dose (200-600 mg/kg) and frequency (every 3 or 4 weeks) as their regular dose at screening or during the Run-In Phase. All 32 subjects completed the IV Phase and entered the SC Phase.~A total of 32 subjects who completed the IV Phase entered the SC Phase. Subjects in the SC Phase received IGIV-C via weekly SC administration for 24 weeks total at a dose that was calculated using a conversion factor and their established IV dose. 25 subjects completed the SC Phase."
10865634|NCT00389324|OG000|Outcome|Gamunex Intravenous (IV) Administration|Subjects who received Gamunex via IV administration.
10865635|NCT00389324|OG001|Outcome|Gamunex Subcutaneous (SC) Administration|Subjects who received Gamunex via SC administration.
10865636|NCT00389324|EG000|Reported Event|Run-In Phase|All subjects who participated in the Run-In Phase.
10865637|NCT00389324|EG001|Reported Event|Intravenous Phase|All subjects who participated in the Intravenous Phase.
10865638|NCT00389324|EG002|Reported Event|Subcutaneous Phase|All subjects who participated in the Subcutaneous Phase.
10865639|NCT00389441|BG000|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
10865640|NCT00389441|FG000|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
10865641|NCT00389441|OG000|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
10865642|NCT00389441|EG000|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
10865643|NCT00389467|BG000|Baseline|Embolectomy, Penumbral|Treatment assignment = embolectomy, imaging pattern = penumbral
10865644|NCT00389467|BG001|Baseline|Standard Care, Penumbral|Treatment assignment = standard medical care, imaging pattern = penumbral
10865645|NCT00389467|BG002|Baseline|Embolectomy, Nonpenumbral|Treatment assignment = embolectomy, imaging pattern = nonpenumbral
10865646|NCT00389467|BG003|Baseline|Standard Care, Nonpenumbral|Treatment assignment = standard medical care, imaging pattern = nonpenumbral
10865647|NCT00389467|BG004|Baseline|Total|Total of all reporting groups
10865648|NCT00389467|FG000|Participant Flow|Embolectomy, Penumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
10879146|NCT00455702|OG000|Outcome|D-cycloserine|50 mg d-cycloserine
10879147|NCT00455702|OG001|Outcome|Placebo|50 mg placebo
10879148|NCT00455702|OG000|Outcome|D-cycloserine|"50 mg d-cycloserine~d-cycloserine: 50mg dose d-cycloserine v placebo"
10879149|NCT00455702|OG001|Outcome|Placebo|"50 mg placebo~d-cycloserine: 50mg dose d-cycloserine v placebo"
10865649|NCT00389467|FG001|Participant Flow|Standard Care, Penumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
10865650|NCT00389467|FG002|Participant Flow|Embolectomy, Nonpenumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
10865651|NCT00389467|FG003|Participant Flow|Standard Care, Nonpenumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
10865652|NCT00389467|OG000|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
10865653|NCT00389467|OG001|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
10865654|NCT00389467|OG002|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
10865655|NCT00389467|OG003|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
10865656|NCT00389467|EG000|Reported Event|Total Cohort|
10865657|NCT00389467|EG001|Reported Event|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
10865658|NCT00389467|EG002|Reported Event|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
10865659|NCT00389467|EG003|Reported Event|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
10865660|NCT00389467|EG004|Reported Event|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
10865661|NCT00389493|BG000|Baseline|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
10865662|NCT00389493|BG001|Baseline|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
10865663|NCT00389493|BG002|Baseline|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
10865664|NCT00389493|BG003|Baseline|Total|Total of all reporting groups
10865665|NCT00389493|FG000|Participant Flow|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
10865666|NCT00389493|FG001|Participant Flow|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
10865667|NCT00389493|FG002|Participant Flow|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
10865668|NCT00389493|OG000|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
10879150|NCT00455702|EG000|Reported Event|D-cycloserine|50 mg d-cycloserine
10879151|NCT00455702|EG001|Reported Event|Placebo|50 mg placebo
10865669|NCT00389493|OG001|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
10865670|NCT00389493|OG002|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
10865671|NCT00389493|OG000|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
10865672|NCT00389493|OG001|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
10865673|NCT00389493|OG002|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
10865674|NCT00389493|EG000|Reported Event|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
10865675|NCT00389493|EG001|Reported Event|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
10865676|NCT00389493|EG002|Reported Event|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
10865677|NCT00389519|BG000|Baseline|Placebo|
10865678|NCT00389519|BG001|Baseline|Ramipril Low Dose|
10865679|NCT00389519|BG002|Baseline|Ramipril Mid Dose|
10865680|NCT00389519|BG003|Baseline|Ramipril High Dose|
10865681|NCT00389519|BG004|Baseline|Total|Total of all reporting groups
10865682|NCT00389519|FG000|Participant Flow|Placebo|
10865683|NCT00389519|FG001|Participant Flow|Ramipril Low Dose|
10865684|NCT00389519|FG002|Participant Flow|Ramipril Mid Dose|
10865685|NCT00389519|FG003|Participant Flow|Ramipril High Dose|
10865686|NCT00389519|OG000|Outcome|Placebo|
10865687|NCT00389519|OG001|Outcome|Ramipril Low Dose|
10865688|NCT00389519|OG002|Outcome|Ramipril Mid Dose|
10865689|NCT00389519|OG003|Outcome|Ramipril High Dose|
10865690|NCT00389519|EG000|Reported Event|Placebo|
10865691|NCT00389519|EG001|Reported Event|Ramipril Low Dose|
10865692|NCT00389519|EG002|Reported Event|Ramipril Mid Dose|
10865693|NCT00389519|EG003|Reported Event|Ramipril High Dose|
10865694|NCT00389532|BG000|Baseline|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
10865695|NCT00389532|BG001|Baseline|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
10865696|NCT00389532|BG002|Baseline|Total|Total of all reporting groups
10865697|NCT00389532|FG000|Participant Flow|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
10865698|NCT00389532|FG001|Participant Flow|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
10865699|NCT00389532|OG000|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
10865700|NCT00389532|OG001|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
10865701|NCT00389532|EG000|Reported Event|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
10865702|NCT00389532|EG001|Reported Event|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
10865703|NCT00389597|BG000|Baseline|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
10865704|NCT00389597|BG001|Baseline|1 Level ACDF|1 level control procedure (ACDF)
10865705|NCT00389597|BG002|Baseline|2 Level TDR|Cervical artificial disc (investigational device) at 2 levels
10865706|NCT00389597|BG003|Baseline|2 Level ACDF|2 level control procedure (ACDF)
10865707|NCT00389597|BG004|Baseline|Total|Total of all reporting groups
10865708|NCT00389597|FG000|Participant Flow|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
10865709|NCT00389597|FG001|Participant Flow|1 Level ACDF|1 level control procedure (ACDF)
10865710|NCT00389597|FG002|Participant Flow|2 Level TDR|Cervical artificial disc (investigational device) at 2 levels
10865711|NCT00389597|FG003|Participant Flow|2 Level ACDF|2 level control procedure (ACDF)
10865712|NCT00389597|OG000|Outcome|1 Level ACDF|control procedure (ACDF) at one level
10865713|NCT00389597|OG001|Outcome|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
10865714|NCT00389597|OG002|Outcome|2 Level ACDF|Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
10865715|NCT00389597|OG003|Outcome|2 Level TDR|control procedure (ACDF) at two levels
10865716|NCT00389597|EG000|Reported Event|1 Level TDR Arm|Cervical artificial disc (investigational device) at 1 level
10865717|NCT00389597|EG001|Reported Event|1 Level ACDF Arm|
10865718|NCT00389597|EG002|Reported Event|2 Level TDR Arm|Cervical artificial disc (investigational device) at 2 levels
10865719|NCT00389597|EG003|Reported Event|2 Level ACDF Arm|
10865720|NCT00389805|BG000|Baseline|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
10865721|NCT00389805|BG001|Baseline|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
10865722|NCT00389805|BG002|Baseline|Total|Total of all reporting groups
10865723|NCT00389805|FG000|Participant Flow|Arm A|Pemetrexed on day 1 (500 -600 mg/m2 IV) and bortezomib twice weekly (0.7-1.3mg/m3) on days 1, 4, 8, and 11 every 21 days
10865724|NCT00389805|FG001|Participant Flow|Arm B|Pemetrexed on day 1 (500 -600 mg/m2 IV) and bortezomib twice weekly (0.7-1.3mg/m2) on days 1 and 8 every 21 days
10865725|NCT00389805|OG000|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
10865726|NCT00389805|OG001|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
10865727|NCT00389805|EG000|Reported Event|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
10865728|NCT00389805|EG001|Reported Event|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
10865729|NCT00389818|BG000|Baseline|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
10865730|NCT00389818|FG000|Participant Flow|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
10865731|NCT00389818|OG000|Outcome|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
10865732|NCT00389818|EG000|Reported Event|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
10865733|NCT00389831|BG000|Baseline|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
10865734|NCT00389831|BG001|Baseline|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
10865735|NCT00389831|BG002|Baseline|Total|Total of all reporting groups
10865736|NCT00389831|FG000|Participant Flow|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
10865737|NCT00389831|FG001|Participant Flow|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
10865738|NCT00389831|OG000|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
10865739|NCT00389831|OG001|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
10865740|NCT00389831|OG002|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
10865741|NCT00389831|OG003|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
10865742|NCT00389831|OG004|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
10865743|NCT00389831|OG005|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
10865744|NCT00389831|OG006|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
10865745|NCT00389831|OG007|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
10865746|NCT00389831|EG000|Reported Event|Placebo - Day 1|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 1.
10865747|NCT00389831|EG001|Reported Event|Placebo - Day 2|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 2.
10865748|NCT00389831|EG002|Reported Event|Placebo - Day 3|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 3.
10865749|NCT00389831|EG003|Reported Event|Placebo - Day 4|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 4.
10865750|NCT00389831|EG004|Reported Event|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
10865751|NCT00389831|EG005|Reported Event|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
10865752|NCT00389831|EG006|Reported Event|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
10865753|NCT00389831|EG007|Reported Event|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
10865754|NCT00389857|BG000|Baseline|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
10865755|NCT00389857|BG001|Baseline|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
10865756|NCT00389857|BG002|Baseline|Total|Total of all reporting groups
10865757|NCT00389857|FG000|Participant Flow|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
10865758|NCT00389857|FG001|Participant Flow|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
10865759|NCT00389857|OG000|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
10865760|NCT00389857|OG001|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
10865761|NCT00389857|EG000|Reported Event|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
10865762|NCT00389857|EG001|Reported Event|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
10865763|NCT00389974|BG000|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
10865764|NCT00389974|FG000|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
10865765|NCT00389974|OG000|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
10865766|NCT00389974|EG000|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
10865767|NCT00390013|BG000|Baseline|All Cross Over Participants|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)~Gabapentin: 300 mg. capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.~at completion of study treatment you will titrate off study drug over a weeks time.~Placebo:~Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (Gabapentin)."
10865768|NCT00390013|BG001|Baseline|Gabapentin (Phase 1)|
10865769|NCT00390013|BG002|Baseline|Placebo (Phase 1)|
10865770|NCT00390013|BG003|Baseline|Total|Total of all reporting groups
10865771|NCT00390013|FG000|Participant Flow|Gabapentin First Then Placebo Crossover|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)~Gabapentin: 300 mg. capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.~at completion of cross-over period 1 you will titrate off study drug over a weeks time.~Placebo:~Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (gabapentin)."
10865772|NCT00390013|FG001|Participant Flow|Placebo Oral Capsule First Then Gabapentin Crossover|"Placebo titration and dosing for total of 8 weeks (Cross over)~Placebo oral capsule: Placebo capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2.~at completion of study treatment (week 11) you will titrate off study drug over a weeks time.~Gabapentin: 300 mg. capsules Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (placebo)."
10865773|NCT00390013|FG002|Participant Flow|Treatment Only (Gabapentin)|1st phase (placebo controlled study) gabapentin 1800 mg max dose
11223137|NCT02351167|FG001|Participant Flow|Varenicline (Chantix) and Counseling|Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
10865774|NCT00390013|FG003|Participant Flow|Placebo Control Arm|1 phase Placebo
10865775|NCT00390013|OG000|Outcome|Gabapentin|
10865776|NCT00390013|OG001|Outcome|Placebo|
10865777|NCT00390013|EG000|Reported Event|Gabapentin|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)~Gabapentin: 300 mg. capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.~at completion of study treatment you will titrate off study drug over a weeks time."
10865778|NCT00390013|EG001|Reported Event|Placebo Oral Capsule|"Placebo titration and dosing for total of 8 weeks (Cross over)~Placebo oral capsule: Placebo capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.~at completion of study treatment you will titrate off study drug over a weeks time."
10865779|NCT00390182|BG000|Baseline|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
10865780|NCT00390182|FG000|Participant Flow|Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9)|4 cycles (1 cycle = 21 days): Gemcitabine 1250/m2 given IV Day 1 and Day 8; with concurrent Low Dose Fractionated Radiation Therapy (LDFRT). The total Radiation dose would be 19.2 Gy divided over 32 fractions. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. Radiotherapy given after the initiation of Gemcitabine Days 1,2,8, and 9.
10865781|NCT00390182|OG000|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
10865782|NCT00390182|EG000|Reported Event|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
10865783|NCT00390221|BG000|Baseline|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
10865784|NCT00390221|BG001|Baseline|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
10865785|NCT00390221|BG002|Baseline|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
10865786|NCT00390221|BG003|Baseline|Total|Total of all reporting groups
10865787|NCT00390221|FG000|Participant Flow|Placebo|Placebo administered as 3 subcutaneous (SC) injections every 4 weeks for up to 52 weeks
10865788|NCT00390221|FG001|Participant Flow|150 mg DAC HYP|150 mg Daclizumab High Yield Process (DAC HYP) administered as 3 SC injections every 4 weeks for up to 52 weeks
10865789|NCT00390221|FG002|Participant Flow|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
10865790|NCT00390221|OG000|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
11223138|NCT02351167|FG002|Participant Flow|Placebo Medicine and Counseling|Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
11223139|NCT02351167|OG000|Outcome|Combination NRT and Counseling|Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
10865791|NCT00390221|OG001|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
10865792|NCT00390221|OG002|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
10865793|NCT00390221|EG000|Reported Event|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
10865794|NCT00390221|EG001|Reported Event|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
10865795|NCT00390221|EG002|Reported Event|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
10865796|NCT00390221|EG003|Reported Event|Total Active|150 mg or 300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
10865797|NCT00390234|BG000|Baseline|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10865798|NCT00390234|FG000|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10865799|NCT00390234|OG000|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10865800|NCT00390234|OG000|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
10865801|NCT00390234|EG000|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10865802|NCT00390299|BG000|Baseline|Arm A (Resection Cavity) - Dose Level 1|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^5 TCID50 MV-CEA administered into the resection cavity on day 1.
10865803|NCT00390299|BG001|Baseline|Arm A (Resection Cavity) - Dose Level 2|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^6 TCID50 MV-CEA administered into the resection cavity on day 1.
10865804|NCT00390299|BG002|Baseline|Arm A (Resection Cavity) - Dose Level 3|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^7 TCID50 MV-CEA administered into the resection cavity on day 1.
10865805|NCT00390299|BG003|Baseline|Arm B (Intratumoral/Resection Cavity) - Dose Level 1|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10^6 TCID50 MV-CEA in resection cavity on day 5.
10865806|NCT00390299|BG004|Baseline|Arm B (Intratumoral/Resection Cavity) - Dose Level 2|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10^7 TCID50 MV-CEA in resection cavity on day 5.
10865807|NCT00390299|BG005|Baseline|Total|Total of all reporting groups
10865808|NCT00390299|FG000|Participant Flow|Arm A (Resection Cavity) - Dose Level 1|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^5 TCID50 MV-CEA administered into the resection cavity on day 1.
10865809|NCT00390299|FG001|Participant Flow|Arm A (Resection Cavity) - Dose Level 2|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^6 TCID50 MV-CEA administered into the resection cavity on day 1.
10865810|NCT00390299|FG002|Participant Flow|Arm A (Resection Cavity) - Dose Level 3|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^7 TCID50 MV-CEA administered into the resection cavity on day 1.
10865811|NCT00390299|FG003|Participant Flow|Arm B (Intratumoral/Resection Cavity) - Dose Level 1|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10^6 TCID50 MV-CEA in resection cavity on day 5.
10865812|NCT00390299|FG004|Participant Flow|Arm B (Intratumoral/Resection Cavity) - Dose Level 2|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10^7 TCID50 MV-CEA in resection cavity on day 5.
11223140|NCT02351167|OG001|Outcome|Varenicline (Chantix) and Counseling|Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
10865813|NCT00390299|OG000|Outcome|Arm A (Resection Cavity) - Dose Level 1|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^5 TCID50 MV-CEA administered into the resection cavity on day 1.
10865814|NCT00390299|OG001|Outcome|Arm A (Resection Cavity) - Dose Level 2|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^6 TCID50 MV-CEA administered into the resection cavity on day 1.
10865815|NCT00390299|OG002|Outcome|Arm A (Resection Cavity) - Dose Level 3|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^7 TCID50 MV-CEA administered into the resection cavity on day 1.
10865816|NCT00390299|OG003|Outcome|Arm B (Intratumoral/Resection Cavity) - Dose Level 1|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10^6 TCID50 MV-CEA in resection cavity on day 5.
10865817|NCT00390299|OG004|Outcome|Arm B (Intratumoral/Resection Cavity) - Dose Level 2|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10^7 TCID50 MV-CEA in resection cavity on day 5.
10865818|NCT00390299|OG000|Outcome|Arm A (Resection Cavity Administration)|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by MV-CEA administered into the resection cavity on day 1.
10865819|NCT00390299|OG001|Outcome|Arm B (Intratumoral and Resection Cavity Administration)|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of MV-CEA in resection cavity on day 5.
10865820|NCT00390299|EG000|Reported Event|Arm A (Resection Cavity) - Dose Level 1|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^5 TCID50 MV-CEA administered into the resection cavity on day 1.
11223141|NCT02351167|OG002|Outcome|Placebo Medicine and Counseling|Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
10865821|NCT00390299|EG001|Reported Event|Arm A (Resection Cavity) - Dose Level 2|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^6 TCID50 MV-CEA administered into the resection cavity on day 1.
10865822|NCT00390299|EG002|Reported Event|Arm A (Resection Cavity) - Dose Level 3|Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10^7 TCID50 MV-CEA administered into the resection cavity on day 1.
10865823|NCT00390299|EG003|Reported Event|Arm B (Intratumoral/Resection Cavity) - Dose Level 1|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10^6 TCID50 MV-CEA in resection cavity on day 5.
10865824|NCT00390299|EG004|Reported Event|Arm B (Intratumoral/Resection Cavity) - Dose Level 2|Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10^7 TCID50 MV-CEA in resection cavity on day 5.
10865825|NCT00390364|BG000|Baseline|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
10865826|NCT00390364|FG000|Participant Flow|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
10865827|NCT00390364|OG000|Outcome|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
10865828|NCT00390364|EG000|Reported Event|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
10865829|NCT00390416|BG000|Baseline|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
10865830|NCT00390416|FG000|Participant Flow|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|"Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin~Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes"
10865831|NCT00390416|OG000|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
10865832|NCT00390416|EG000|Reported Event|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
10865833|NCT00390429|BG000|Baseline|Phase I, Arm A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865834|NCT00390429|BG001|Baseline|Phase I, Arm B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865835|NCT00390429|BG002|Baseline|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865836|NCT00390429|BG003|Baseline|Total|Total of all reporting groups
10865837|NCT00390429|FG000|Participant Flow|Phase I, Group A (1200 mg Erlotinib + 70mg/m2 Docetaxel)|"Original Dose Level~Patients receive docetaxel IV over 1 hour on day 1 and oral Erlotinib hydrochloride once on days 2, 9, and 16 and Docetaxel on days 1 and 22. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~Docetaxel: Given IV Erlotinib hydrochloride: Given orally"
10865838|NCT00390429|FG001|Participant Flow|Phase I, Group A (600 mg Erlotinib + 70mg/m2 Docetaxel)|"Patients receive docetaxel IV over 1 hour on day 1 and oral Erlotinib hydrochloride once on days 2, 9, and 16 and Docetaxel on days 1 and 22. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~Docetaxel: Given IV Erlotinib hydrochloride: Given orally"
10865839|NCT00390429|FG002|Participant Flow|Phase I, Group B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
10865840|NCT00390429|FG003|Participant Flow|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
10865841|NCT00390429|OG000|Outcome|Phase I, Arm A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865842|NCT00390429|OG001|Outcome|Phase I, Arm B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865843|NCT00390429|OG002|Outcome|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865844|NCT00390429|OG000|Outcome|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865845|NCT00390429|OG000|Outcome|Phase I, Group A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
10865846|NCT00390429|OG001|Outcome|Phase I, Group B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
11223142|NCT02351167|OG003|Outcome|3 Arms Combined|This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
10865847|NCT00390429|EG000|Reported Event|Phase I, Arm A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865848|NCT00390429|EG001|Reported Event|Phase I, Arm B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865849|NCT00390429|EG002|Reported Event|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
10865850|NCT00390455|BG000|Baseline|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
10865851|NCT00390455|BG001|Baseline|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
10865852|NCT00390455|BG002|Baseline|Total|Total of all reporting groups
10865853|NCT00390455|FG000|Participant Flow|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
10865854|NCT00390455|FG001|Participant Flow|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
10865855|NCT00390455|OG000|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
10865856|NCT00390455|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
10865857|NCT00390455|EG000|Reported Event|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
10865858|NCT00390455|EG001|Reported Event|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
10865859|NCT00390468|BG000|Baseline|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
10865860|NCT00390468|FG000|Participant Flow|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
10865861|NCT00390468|OG000|Outcome|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
10865862|NCT00390468|EG000|Reported Event|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
10865863|NCT00390546|BG000|Baseline|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
10865864|NCT00390546|BG001|Baseline|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
10865865|NCT00390546|BG002|Baseline|Total|Total of all reporting groups
10865866|NCT00390546|FG000|Participant Flow|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
10865867|NCT00390546|FG001|Participant Flow|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
10865868|NCT00390546|OG000|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
10865869|NCT00390546|OG001|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
10865870|NCT00390546|OG001|Outcome|Propranolol|Single dose administered orally at 0.5/kg per dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
10865871|NCT00390546|EG000|Reported Event|Digoxin|
10865872|NCT00390546|EG001|Reported Event|Propranolol|
10865873|NCT00390559|BG000|Baseline|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
10865874|NCT00390559|FG000|Participant Flow|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
10865875|NCT00390559|OG000|Outcome|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
10865876|NCT00390559|OG001|Outcome|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
10865877|NCT00390559|OG002|Outcome|Active P/PlaceboC|21 mg patch/no nicotine cigarette
10865878|NCT00390559|OG003|Outcome|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
10865879|NCT00390559|EG000|Reported Event|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
10865880|NCT00390559|EG001|Reported Event|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
10865881|NCT00390559|EG002|Reported Event|Active P/PlaceboC|21 mg patch/no nicotine cigarette
10865882|NCT00390559|EG003|Reported Event|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
10865883|NCT00390572|BG000|Baseline|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
11223143|NCT02351167|EG000|Reported Event|Combination NRT and Counseling|Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
11223144|NCT02351167|EG001|Reported Event|Varenicline (Chantix) and Counseling|Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
11223145|NCT02351167|EG002|Reported Event|Placebo Medicine and Counseling|Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
11223146|NCT02351258|BG000|Baseline|All Clinics|All 16 clinics included in this cluster-randomized trial.
11223147|NCT02351258|FG000|Participant Flow|Usual Care Only, Then Usual Care + 70% Isopropyl Alcohol|Usual care for central line while patients are at home and then switch to usual care plus 70% isopropyl alcohol after washout.
11223148|NCT02351258|FG001|Participant Flow|Usual Care + 70% Isopropyl Alcohol, Then Usual Care Only|Use of 70% isopropyl alcohol embedded caps on central lines in addition to usual care of central line in the home setting and then switch to usual care only after washout.
11223149|NCT02351258|OG000|Outcome|Usual Care Only|Clinics using usual care only.
11223150|NCT02351258|OG001|Outcome|Usual Care + 70% Isopropyl Alcohol|Clinics using usual care + 70% isopropyl alcohol.
11223151|NCT02351258|EG000|Reported Event|All Clinics|All 16 clinics included in this cluster-randomized trial.
11223152|NCT02351271|BG000|Baseline|Femto LDV Z8|"Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification~Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification~33 males (48.5%) and 35 females (51.5%) in the FLACS group"
11223153|NCT02351271|BG001|Baseline|Manual Capsulorhexis&Lens Fragmentation|"The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification~Manual capsulorhexis&lens fragmentation: Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device~25 (40.3%) males and 37 females (59.7%) in the manual group"
11223154|NCT02351271|BG002|Baseline|Total|Total of all reporting groups
11223155|NCT02351271|FG000|Participant Flow|Femto LDV Z8|"Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification~Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification~33 males (48.5%) and 35 females (51.5%) in the FLACS group"
11223156|NCT02351271|FG001|Participant Flow|Manual Capsulorhexis&Lens Fragmentation|"The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification~Manual capsulorhexis&lens fragmentation: Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device~25 (40.3%) males and 37 females (59.7%) in the manual group"
11223157|NCT02351271|OG000|Outcome|Femto LDV Z8|"Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification~Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification~33 males (48.5%) and 35 females (51.5%) in the FLACS group"
11223158|NCT02351271|OG001|Outcome|Manual Capsulorhexis&Lens Fragmentation|"The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification~Manual capsulorhexis&lens fragmentation: Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device~25 (40.3%) males and 37 females (59.7%) in the manual group"
11223159|NCT02351271|OG000|Outcome|Femto LDV Z8|"Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification~Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification"
10865884|NCT00390572|BG001|Baseline|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
10865885|NCT00390572|BG002|Baseline|Total|Total of all reporting groups
10865886|NCT00390572|FG000|Participant Flow|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers."
10865887|NCT00390572|FG001|Participant Flow|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
11223160|NCT02351271|OG001|Outcome|Manual Capsulorhexis&Lens Fragmentation|"The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification~Manual capsulorhexis&lens fragmentation: Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device"
11223161|NCT02351271|EG000|Reported Event|Femto LDV Z8|"Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification~Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification"
10865888|NCT00390572|OG000|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
10865889|NCT00390572|OG001|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
10865890|NCT00390572|EG000|Reported Event|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
10865891|NCT00390572|EG001|Reported Event|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
10865892|NCT00390611|BG000|Baseline|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
10865893|NCT00390611|BG001|Baseline|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
10865894|NCT00390611|BG002|Baseline|Total|Total of all reporting groups
10865895|NCT00390611|FG000|Participant Flow|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
10865896|NCT00390611|FG001|Participant Flow|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
10865897|NCT00390611|OG000|Outcome|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
10865898|NCT00390611|OG001|Outcome|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
10865899|NCT00390611|OG000|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
10865900|NCT00390611|OG001|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
10865901|NCT00390611|EG000|Reported Event|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
10865902|NCT00390611|EG001|Reported Event|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
10865903|NCT00390689|BG000|Baseline|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865904|NCT00390689|BG001|Baseline|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865905|NCT00390689|BG002|Baseline|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865906|NCT00390689|BG003|Baseline|Total|Total of all reporting groups
10865907|NCT00390689|FG000|Participant Flow|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865908|NCT00390689|FG001|Participant Flow|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865909|NCT00390689|FG002|Participant Flow|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865910|NCT00390689|OG000|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865911|NCT00390689|OG001|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865912|NCT00390689|OG002|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
11223162|NCT02351271|EG001|Reported Event|Manual Capsulorhexis&Lens Fragmentation|"The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification~Manual capsulorhexis&lens fragmentation: Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device"
11223163|NCT02351349|BG000|Baseline|Multidisciplinary Intervention|"Due to the problem of randomization, the study became a before and after assessment in the one group that completed the 12 week exercise program and received nutritional support~multidisciplinary intervention: multidisciplinary intervention"
10865913|NCT00390689|OG000|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865914|NCT00390689|OG001|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865915|NCT00390689|OG002|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865916|NCT00390689|OG003|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865917|NCT00390689|OG002|Outcome|Pramipexole 0.50mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865918|NCT00390689|EG000|Reported Event|Pramipexole 0.25mg (Double-blind)|"Double-blind period: 0.25 mg randomised group.~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily"
10865919|NCT00390689|EG001|Reported Event|Pramipexole 0.50mg (Double-blind)|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily"
10865920|NCT00390689|EG002|Reported Event|Pramipexole 0.75mg (Double-blind)|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily"
10865921|NCT00390689|EG003|Reported Event|Pramipexole 0.125mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865922|NCT00390689|EG004|Reported Event|Pramipexole 0.25mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865923|NCT00390689|EG005|Reported Event|Pramipexole 0.50mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865924|NCT00390689|EG006|Reported Event|Pramipexole 0.75mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
10865925|NCT00390780|BG000|Baseline|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
10865926|NCT00390780|BG001|Baseline|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
10865927|NCT00390780|BG002|Baseline|Total|Total of all reporting groups
10865928|NCT00390780|FG000|Participant Flow|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
10865929|NCT00390780|FG001|Participant Flow|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day, for 14 days
10865930|NCT00390780|OG000|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
10865931|NCT00390780|OG001|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
10865932|NCT00390780|EG000|Reported Event|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
10865933|NCT00390780|EG001|Reported Event|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
10865934|NCT00390806|BG000|Baseline|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
10865935|NCT00390806|BG001|Baseline|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
10865936|NCT00390806|BG002|Baseline|Total|Total of all reporting groups
10865937|NCT00390806|FG000|Participant Flow|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
10865938|NCT00390806|FG001|Participant Flow|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
10865939|NCT00390806|OG000|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
10865940|NCT00390806|OG001|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
10865941|NCT00390806|EG000|Reported Event|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
10865942|NCT00390806|EG001|Reported Event|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
10865943|NCT00390858|BG000|Baseline|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
10865944|NCT00390858|BG001|Baseline|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
10865945|NCT00390858|BG002|Baseline|Total|Total of all reporting groups
10865946|NCT00390858|FG000|Participant Flow|Children ( < 12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
10865947|NCT00390858|FG001|Participant Flow|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
11223164|NCT02351349|BG001|Baseline|Control|Those who were offered the program but did not complete the prescription
10865948|NCT00390858|OG000|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
10865949|NCT00390858|OG001|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
10865950|NCT00390858|EG000|Reported Event|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
10865951|NCT00390858|EG001|Reported Event|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
10865952|NCT00390884|BG000|Baseline|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
10865953|NCT00390884|BG001|Baseline|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
10865954|NCT00390884|BG002|Baseline|Total|Total of all reporting groups
10865955|NCT00390884|FG000|Participant Flow|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
10865956|NCT00390884|FG001|Participant Flow|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
10865957|NCT00390884|OG000|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
10865958|NCT00390884|OG001|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
10865959|NCT00390884|EG000|Reported Event|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
10865960|NCT00390884|EG001|Reported Event|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
10865961|NCT00390910|BG000|Baseline|Synflorix™ + Infanrix™ Hexa Group I|Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
10865962|NCT00390910|BG001|Baseline|Synflorix™ + Infanrix™ Hexa Group II|Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
10865963|NCT00390910|BG002|Baseline|Synflorix™ + Infanrix™ Hexa Group III|Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
10865964|NCT00390910|BG003|Baseline|Total|Total of all reporting groups
10865965|NCT00390910|FG000|Participant Flow|Synflorix™ + Infanrix™ Hexa Group I|Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
10865966|NCT00390910|FG001|Participant Flow|Synflorix™ + Infanrix™ Hexa Group II|Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
10865967|NCT00390910|FG002|Participant Flow|Synflorix™ + Infanrix™ Hexa Group III|Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
10865968|NCT00390910|OG000|Outcome|Synflorix™ + Infanrix™ Hexa Group III|Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
10865969|NCT00390910|OG001|Outcome|Pooled Group I + II|Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
10865970|NCT00390910|OG000|Outcome|Synflorix™ + Infanrix™ Hexa Group I|Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
10865971|NCT00390910|OG001|Outcome|Synflorix™ + Infanrix™ Hexa Group II|Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
10865972|NCT00390910|OG002|Outcome|Synflorix™ + Infanrix™ Hexa Group III|Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
10865973|NCT00390910|EG000|Reported Event|Synflorix™ + Infanrix™ Hexa Group I|Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
10865974|NCT00390910|EG001|Reported Event|Synflorix™ + Infanrix™ Hexa Group II|Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
10865975|NCT00390910|EG002|Reported Event|Synflorix™ + Infanrix™ Hexa Group III|Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
10865976|NCT00390949|BG000|Baseline|Control Arm|Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
10879152|NCT00455741|BG000|Baseline|Younger PMW|"Postmenopausal women (PMW) ages 45-55 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10865977|NCT00390949|BG001|Baseline|Intervention Arm|In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
10865978|NCT00390949|BG002|Baseline|Total|Total of all reporting groups
10865979|NCT00390949|FG000|Participant Flow|Control Arm|Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
10865980|NCT00390949|FG001|Participant Flow|Intervention Arm|In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
10865981|NCT00390949|OG000|Outcome|Control Arm|Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
10865982|NCT00390949|OG001|Outcome|Intervention Arm|In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
10865983|NCT00390949|EG000|Reported Event|Control Arm|Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
10865984|NCT00390949|EG001|Reported Event|Intervention Arm|In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
10865985|NCT00391027|BG000|Baseline|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
10865986|NCT00391027|BG001|Baseline|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
10865987|NCT00391027|BG002|Baseline|Total|Total of all reporting groups
11223165|NCT02351349|BG002|Baseline|Total|Total of all reporting groups
11223166|NCT02351349|FG000|Participant Flow|Intervention: Multi Intervention|"Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support~multidisciplinary intervention: multidisciplinary intervention"
11223167|NCT02351349|FG001|Participant Flow|Control|These individuals did not receive exercise advice and did not see the dietician unless there was a clinical problem
10865988|NCT00391027|FG000|Participant Flow|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
11223168|NCT02351349|OG000|Outcome|Intervention: Multi Intervention|"Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support~multidisciplinary intervention: multidisciplinary intervention"
10865989|NCT00391027|FG001|Participant Flow|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
11223169|NCT02351349|OG001|Outcome|Control|those who were randomized to no exercise program
11223170|NCT02351349|OG001|Outcome|Control|those who were not randomized to the exercise group
11223171|NCT02351349|OG001|Outcome|Control|those who were not in the exercise group
11223172|NCT02351349|OG000|Outcome|Multidisciplinary Intervention|"Due to the problem of randomization, the study became a before and after assessment in the one group that completed the 12 week exercise program and received nutritional support~multidisciplinary intervention: multidisciplinary intervention"
11223173|NCT02351349|OG001|Outcome|Control|Those who were randomized not to the exercise program
11223174|NCT02351349|OG001|Outcome|Control|Those who were randomized not to the exercise group
11126385|NCT01733069|FG000|Participant Flow|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses.
10865990|NCT00391027|OG000|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
10865991|NCT00391027|OG001|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
10865992|NCT00391027|EG000|Reported Event|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
10865993|NCT00391027|EG001|Reported Event|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
10865994|NCT00391053|BG000|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
10865995|NCT00391053|BG001|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
10865996|NCT00391053|BG002|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
11223175|NCT02351349|EG000|Reported Event|Intervention: Multi Intervention|"Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support~multidisciplinary intervention: multidisciplinary intervention"
10865997|NCT00391053|BG003|Baseline|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
10865998|NCT00391053|BG004|Baseline|Total|Total of all reporting groups
10865999|NCT00391053|FG000|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
10866000|NCT00391053|FG001|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
10866001|NCT00391053|FG002|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
10866002|NCT00391053|FG003|Participant Flow|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
10866003|NCT00391053|OG000|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
10866004|NCT00391053|OG001|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
10866005|NCT00391053|OG002|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
10866006|NCT00391053|OG003|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
10866007|NCT00391053|EG000|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|
10866008|NCT00391053|EG001|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|
10866009|NCT00391053|EG002|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|
10866010|NCT00391053|EG003|Reported Event|Standad Dose Inactivated, Split-Virion Influenza Vaccine|
10866011|NCT00391079|BG000|Baseline|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
10866012|NCT00391079|BG001|Baseline|Placebo|Range of 8-12 sprays per day of placebo spray.
10866013|NCT00391079|BG002|Baseline|Total|Total of all reporting groups
10866014|NCT00391079|FG000|Participant Flow|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
10866015|NCT00391079|FG001|Participant Flow|Placebo|Range of 8-12 sprays per day of placebo spray.
10866016|NCT00391079|OG000|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
10866017|NCT00391079|OG001|Outcome|Placebo|Range of 8-12 sprays of placebo per day
10866018|NCT00391079|EG000|Reported Event|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
10866019|NCT00391079|EG001|Reported Event|Placebo|Range of 8-12 sprays of placebo per day
10866020|NCT00391092|BG000|Baseline|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
10866021|NCT00391092|BG001|Baseline|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
10866022|NCT00391092|BG002|Baseline|Total|Total of all reporting groups
10866023|NCT00391092|FG000|Participant Flow|Trastuzumab + Docetaxel|Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
10866024|NCT00391092|FG001|Participant Flow|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
10866025|NCT00391092|OG000|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
10866026|NCT00391092|OG001|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
10866027|NCT00391092|EG000|Reported Event|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
10866028|NCT00391092|EG001|Reported Event|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
11223176|NCT02351349|EG001|Reported Event|Control|those who were randomized to the no exercise group
10866029|NCT00391118|BG000|Baseline|Part 1 - Modified Regimen A|"Enzastaurin: 1125 mg loading dose on Cycle 1 Day 4 then 500 mg oral tablet, QD, for six 21-day cycles on subsequent days of chemotherapy~Carboplatin: AUC5, IV, q21 days, for six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for six 21-day cycles of chemotherapy"
10866030|NCT00391118|BG001|Baseline|Part 2 - Regimen A|"Enzastaurin: 1125 mg loading dose then 500 mg oral tablet, QD, for up to six 21-day cycles on subsequent days of chemotherapy and maintenance therapy up to 2 years~Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy"
10866031|NCT00391118|BG002|Baseline|Part 2 - Regimen B|"Carboplatin: AUC5 IV, q21 days, for up to six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy~Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years"
10866032|NCT00391118|BG003|Baseline|Total|Total of all reporting groups
10866033|NCT00391118|FG000|Participant Flow|Part 1 - Modified Regimen A|"Enzastaurin: 1125 milligrams (mg) loading dose on Cycle 1 Day 4 then 500 mg oral tablet, daily (QD), for six 21-day cycles on subsequent days of chemotherapy~Carboplatin: Area under the concentration time curve (AUC)5 intravenous (IV), every (q) 21 days, for six 21-day cycles of chemotherapy~Paclitaxel: 175 milligrams/square meter (mg/m²), IV, q21 days, for six 21-day cycles of chemotherapy"
10866034|NCT00391118|FG001|Participant Flow|Part 2 - Regimen A|"Enzastaurin: 1125 mg loading dose then 500 mg oral tablet on subsequent days, QD, for six 21-day cycles of chemotherapy and maintenance therapy up to 2 years~Carboplatin: AUC5, IV, q21 days, for six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for six 21-day cycles of chemotherapy"
10866035|NCT00391118|FG002|Participant Flow|Part 2 - Regimen B|"Carboplatin: AUC5, IV, q21 days for six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days for six 21-day cycles of chemotherapy~Placebo: oral tablet, QD of chemotherapy and maintenance therapy up to 2 years"
11223177|NCT02351505|BG000|Baseline|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10866036|NCT00391118|OG000|Outcome|Part 2 - Regimen A|"Enzastaurin: 1125 mg loading dose then 500 mg oral tablet, QD, for up to six 21-day cycles on subsequent days of chemotherapy and maintenance therapy up to 2 years~Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy"
10866037|NCT00391118|OG001|Outcome|Part 2 - Regimen B|"Carboplatin: AUC5 IV, q21 days, for up to six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy~Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years"
10866038|NCT00391118|OG001|Outcome|Part 2 - Regimen B|"Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy~Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years"
10866039|NCT00391118|OG000|Outcome|Part 1 - Modified Regimen A|"Enzastaurin: 1125 mg loading dose on Cycle 1 Day 4 then 500 mg oral tablet, QD, for six 21-day cycles on subsequent days of chemotherapy~Carboplatin: AUC5, IV, q 21 days, for six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for six 21-day cycles of chemotherapy"
10866040|NCT00391118|OG001|Outcome|Part 2 - Regimen A|"Enzastaurin: 1125 mg loading dose then 500 mg oral tablet, QD, for up to six 21-day cycles on subsequent days of chemotherapy and maintenance therapy up to 2 years~Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy"
10866041|NCT00391118|OG002|Outcome|Part 2 - Regimen B|"Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy~Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy~Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years"
10866042|NCT00391118|EG000|Reported Event|Part 1 - Modified Regimen A|"Enzastaurin: 1125 mg loading dose on Cycle 1 Day 4, then 500 mg oral tablet, QD, for six 21-day cycles on subsequent days of chemotherapy~Carboplatin: AUC5, IV, q21 days, for six 21-day cycles~Paclitaxel: 175 mg/m² IV, q21 days, for six 21-day cycles"
10866043|NCT00391118|EG001|Reported Event|Part 2 - Regimen A|"Enzastaurin: 1125 mg loading dose then 500 mg, oral tablets on subsequent days, QD, for six 21-day cycles or up to 2 years~Carboplatin: AUC5, IV, q 21 days, for six 21-day cycles~Paclitaxel: 175 mg/m², IV, q21 days, for six 21-day cycles"
10866044|NCT00391118|EG002|Reported Event|Part 2 - Regimen B|"Carboplatin: AUC5, IV, q21 days, for six 21-day cycles~Paclitaxel: 175 mg/m2² IV, q 21 days, six 21 day cycles~Placebo: oral tablet, QD"
10866045|NCT00391222|BG000|Baseline|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable intramuscular every 14 days and oral placebo daily
10866046|NCT00391222|BG001|Baseline|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
10866047|NCT00391222|BG002|Baseline|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine 10 mg/day
10866048|NCT00391222|BG003|Baseline|Total|Total of all reporting groups
10866049|NCT00391222|FG000|Participant Flow|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
10866050|NCT00391222|FG001|Participant Flow|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
10866051|NCT00391222|FG002|Participant Flow|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
10866052|NCT00391222|FG003|Participant Flow|Open-label Risperidone LAI|Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days
10866053|NCT00391222|OG000|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
10866054|NCT00391222|OG001|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
10866055|NCT00391222|OG002|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
10866056|NCT00391222|OG000|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
10866057|NCT00391222|EG000|Reported Event|Risperidone LAI|Double-blind Period III: risperidone LAI 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
10866058|NCT00391222|EG001|Reported Event|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
10866059|NCT00391222|EG002|Reported Event|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
10866060|NCT00391222|EG003|Reported Event|Open-label Risperidone LAI|risperidone 25, 37.5, or 50 mg intramuscular every 14 days
10866061|NCT00391274|BG000|Baseline|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
10866062|NCT00391274|BG001|Baseline|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
10866063|NCT00391274|BG002|Baseline|Total|Total of all reporting groups
10866064|NCT00391274|FG000|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
10866065|NCT00391274|FG001|Participant Flow|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
10866066|NCT00391274|OG000|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
10866067|NCT00391274|OG001|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
10866068|NCT00391274|EG000|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
10866069|NCT00391274|EG001|Reported Event|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
10866070|NCT00391391|BG000|Baseline|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
10866071|NCT00391391|BG001|Baseline|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
10866072|NCT00391391|BG002|Baseline|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
10866073|NCT00391391|BG003|Baseline|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
10866074|NCT00391391|BG004|Baseline|Total|Total of all reporting groups
10866075|NCT00391391|FG000|Participant Flow|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
10866076|NCT00391391|FG001|Participant Flow|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
10866077|NCT00391391|FG002|Participant Flow|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
10866078|NCT00391391|FG003|Participant Flow|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
10866079|NCT00391391|OG000|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
10866080|NCT00391391|OG001|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
10866081|NCT00391391|OG002|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
10866082|NCT00391391|OG003|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
10866083|NCT00391391|EG000|Reported Event|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
10866084|NCT00391391|EG001|Reported Event|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
10866085|NCT00391391|EG002|Reported Event|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
10866086|NCT00391391|EG003|Reported Event|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
10866087|NCT00391443|BG000|Baseline|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
10866088|NCT00391443|BG001|Baseline|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
10866089|NCT00391443|BG002|Baseline|Total|Total of all reporting groups
10866090|NCT00391443|FG000|Participant Flow|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
10866091|NCT00391443|FG001|Participant Flow|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
10866092|NCT00391443|OG000|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
10866093|NCT00391443|OG001|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
10866094|NCT00391443|EG000|Reported Event|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
10866095|NCT00391443|EG001|Reported Event|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
10866096|NCT00391469|BG000|Baseline|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
10866097|NCT00391469|BG001|Baseline|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
10866098|NCT00391469|BG002|Baseline|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
10866099|NCT00391469|BG003|Baseline|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
10866100|NCT00391469|BG004|Baseline|Total|Total of all reporting groups
10866101|NCT00391469|FG000|Participant Flow|Intervention|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
10866102|NCT00391469|FG001|Participant Flow|Control|standard of care
10866103|NCT00391469|OG000|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
10866104|NCT00391469|OG001|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
10866105|NCT00391469|OG002|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
10866106|NCT00391469|OG003|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
10866107|NCT00391469|EG000|Reported Event|Intervention-hypo|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
10866108|NCT00391469|EG001|Reported Event|Control-standard Care|standard care
10866109|NCT00391586|BG000|Baseline|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
10866110|NCT00391586|FG000|Participant Flow|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
10866111|NCT00391586|OG000|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
10866112|NCT00391586|EG000|Reported Event|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
10866113|NCT00391599|BG000|Baseline|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema"
10866114|NCT00391599|BG001|Baseline|Control Group|no preoperative intestinal preparation.
10866115|NCT00391599|BG002|Baseline|Total|Total of all reporting groups
10866116|NCT00391599|FG000|Participant Flow|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
10866117|NCT00391599|FG001|Participant Flow|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
10866118|NCT00391599|OG000|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
10866119|NCT00391599|OG001|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
10866120|NCT00391599|OG000|Outcome|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema"
10866121|NCT00391599|OG001|Outcome|Control Group|"no preoperative intestinal preparation.~enema"
10866122|NCT00391599|EG000|Reported Event|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema~the night before cesarean section"
10866123|NCT00391599|EG001|Reported Event|Control Group|"no preoperative intestinal preparation.~the night before cesarean section"
10866124|NCT00391625|BG000|Baseline|GA-GCB|15-60 U/kg every other week via intravenous infusion
10866125|NCT00391625|FG000|Participant Flow|GA-GCB|15-60 U/kg every other week via intravenous infusion
10866126|NCT00391625|OG000|Outcome|Number (#) Experienced no Adverse Event (AE)|15-60 U/kg every other week via intravenous infusion
10866127|NCT00391625|OG001|Outcome|# Experienced at Least 1 AE|15-60 U/kg, every other week Intravenously
10866128|NCT00391625|OG002|Outcome|# Experienced at Least 1 Drug-related AE|15-60 U/kg, every other week Intravenously
10866129|NCT00391625|OG003|Outcome|# Experienced at Least 1 Infusion-related AE|15-60 U/kg, every other week Intravenously
10866130|NCT00391625|OG004|Outcome|# Experienced at Least 1 Severe AE|15-60 U/kg, every other week Intravenously
10866131|NCT00391625|OG005|Outcome|# Experienced at Least 1 Drug-related Severe AE|15-60 U/kg, every other week Intravenously
10866132|NCT00391625|OG006|Outcome|# Experienced at Least 1 Life-threatening AE|15-60 U/kg, every other week Intravenously
10866133|NCT00391625|OG007|Outcome|# Experienced at Least 1 Serious AE|15-60 U/kg, every other week Intravenously
10866134|NCT00391625|OG008|Outcome|# Experienced at Least 1 Drug-related Serious AE|15-60 U/kg, every other week Intravenously
10866135|NCT00391625|OG009|Outcome|# Discontinued Due to an AE|15-60 U/kg, every other week Intravenously
10866136|NCT00391625|OG010|Outcome|# Deaths|
10866137|NCT00391625|OG000|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
10866138|NCT00391625|OG001|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
10866139|NCT00391625|OG002|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
10866140|NCT00391625|OG003|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
10866141|NCT00391625|OG004|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
10866142|NCT00391625|OG005|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
10866143|NCT00391625|OG006|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
10866144|NCT00391625|OG000|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
10866145|NCT00391625|OG001|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
10866146|NCT00391625|OG002|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
10866147|NCT00391625|OG003|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
10866148|NCT00391625|OG004|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
10866149|NCT00391625|OG005|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
10866150|NCT00391625|EG000|Reported Event|GA-GCB|
10866151|NCT00391716|BG000|Baseline|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
10866152|NCT00391716|BG001|Baseline|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
10866153|NCT00391716|BG002|Baseline|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
10866154|NCT00391716|BG003|Baseline|Total|Total of all reporting groups
10866155|NCT00391716|FG000|Participant Flow|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
10866156|NCT00391716|FG001|Participant Flow|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
10866157|NCT00391716|FG002|Participant Flow|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
10866158|NCT00391716|OG000|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
10866159|NCT00391716|OG001|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
10866160|NCT00391716|OG002|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
10866161|NCT00391716|EG000|Reported Event|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
10866162|NCT00391716|EG001|Reported Event|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
10866163|NCT00391716|EG002|Reported Event|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
10866164|NCT00391768|BG000|Baseline|Cohort IA|12 - 23 months of age, 30 mg
10866165|NCT00391768|BG001|Baseline|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
10866166|NCT00391768|BG002|Baseline|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
10866167|NCT00391768|BG003|Baseline|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
10866168|NCT00391768|BG004|Baseline|Cohort III|6 to 8 months of age, 3 mg/kg body weight
10866169|NCT00391768|BG005|Baseline|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
10866170|NCT00391768|BG006|Baseline|Cohort V|0 to 2 months of age, 3 mg/kg body weight
10866171|NCT00391768|BG007|Baseline|Total|Total of all reporting groups
10866172|NCT00391768|FG000|Participant Flow|Cohort IA|12 - 23 months of age, 30 mg
10866173|NCT00391768|FG001|Participant Flow|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
10866174|NCT00391768|FG002|Participant Flow|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
10866175|NCT00391768|FG003|Participant Flow|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
10866176|NCT00391768|FG004|Participant Flow|Cohort III|6 to 8 months of age, 3 mg/kg body weight
10866177|NCT00391768|FG005|Participant Flow|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
10866178|NCT00391768|FG006|Participant Flow|Cohort V|0 to 2 months of age, 3 mg/kg body weight
10866179|NCT00391768|OG000|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
10866180|NCT00391768|OG001|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
10866181|NCT00391768|OG002|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
10866182|NCT00391768|OG003|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
10866183|NCT00391768|OG004|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
10866184|NCT00391768|OG005|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
10866185|NCT00391768|OG006|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
10866186|NCT00391768|OG000|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days.
10866187|NCT00391768|OG001|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
10866188|NCT00391768|OG002|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
10866189|NCT00391768|OG003|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
10866190|NCT00391768|OG004|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
10866191|NCT00391768|OG005|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
10866192|NCT00391768|OG006|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
10866193|NCT00391768|OG000|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days
10866194|NCT00391768|OG001|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days
10866195|NCT00391768|OG002|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
10866196|NCT00391768|OG004|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
10866197|NCT00391768|OG000|Outcome|Cohort IA|12 - 23 months of age, 30 mg
11223178|NCT02351505|FG000|Participant Flow|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study: Correlative studies"
10866198|NCT00391768|OG001|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
10866199|NCT00391768|OG002|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
10866200|NCT00391768|OG003|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
10866201|NCT00391768|OG004|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
10866202|NCT00391768|OG005|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
10866203|NCT00391768|OG006|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
10866204|NCT00391768|EG000|Reported Event|Cohort IA|12 - 23 months of age, 30 mg
10866205|NCT00391768|EG001|Reported Event|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
10866206|NCT00391768|EG002|Reported Event|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
10866207|NCT00391768|EG003|Reported Event|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
10866208|NCT00391768|EG004|Reported Event|Cohort III|6 to 8 months of age, 3 mg/kg body weight
10866209|NCT00391768|EG005|Reported Event|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
10866210|NCT00391768|EG006|Reported Event|Cohort V|0 to 2 months of age, 3 mg/kg body weight
10866211|NCT00391807|BG000|Baseline|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
10866212|NCT00391807|FG000|Participant Flow|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
10866213|NCT00391807|OG000|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
10866214|NCT00391807|EG000|Reported Event|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
10866215|NCT00391846|BG000|Baseline|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
10866216|NCT00391846|BG001|Baseline|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
10866217|NCT00391846|BG002|Baseline|Total|Total of all reporting groups
10866218|NCT00391846|FG000|Participant Flow|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
10866219|NCT00391846|FG001|Participant Flow|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
10866220|NCT00391846|OG000|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
10866221|NCT00391846|OG001|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
10866222|NCT00391846|EG000|Reported Event|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
10866223|NCT00391846|EG001|Reported Event|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
10866224|NCT00391872|BG000|Baseline|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
10866225|NCT00391872|BG001|Baseline|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
10866226|NCT00391872|BG002|Baseline|Total|Total of all reporting groups
10866227|NCT00391872|FG000|Participant Flow|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
10866228|NCT00391872|FG001|Participant Flow|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
10866229|NCT00391872|OG000|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
10866230|NCT00391872|OG001|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
10866231|NCT00391872|EG000|Reported Event|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
10866232|NCT00391872|EG001|Reported Event|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
10866233|NCT00391898|BG000|Baseline|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
10866234|NCT00391898|BG001|Baseline|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
10866235|NCT00391898|BG002|Baseline|Total|Total of all reporting groups
10866236|NCT00391898|FG000|Participant Flow|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
10866237|NCT00391898|FG001|Participant Flow|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
10866238|NCT00391898|OG000|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
10866239|NCT00391898|OG001|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
10866240|NCT00391898|EG000|Reported Event|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
10866241|NCT00391898|EG001|Reported Event|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
10866242|NCT00391976|BG000|Baseline|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
10866243|NCT00391976|BG001|Baseline|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
10866244|NCT00391976|BG002|Baseline|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
10866245|NCT00391976|BG003|Baseline|Total|Total of all reporting groups
10866246|NCT00391976|FG000|Participant Flow|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
10866247|NCT00391976|FG001|Participant Flow|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
10866248|NCT00391976|FG002|Participant Flow|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
10866249|NCT00391976|OG000|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
10866250|NCT00391976|OG001|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
10866251|NCT00391976|OG002|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
10866252|NCT00391976|EG000|Reported Event|Tobramycin 28 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
10866253|NCT00391976|EG001|Reported Event|Tobramycin 56 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
10866254|NCT00391976|EG002|Reported Event|Non-randomized Patients up to Month 3|Patients who started the study and received tobramycin 300 mg twice a day for 28 days but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups.
10866255|NCT00391976|EG003|Reported Event|Tobramycin 28 Days After Month 3|Patients who received tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
10866256|NCT00391976|EG004|Reported Event|Tobramycin 56 Days After Month 3|Patients received tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
10866257|NCT00391989|BG000|Baseline|Dasatinib|All patients registered in the study.
10866258|NCT00391989|FG000|Participant Flow|Study Group|All patients registered in the study.
10866259|NCT00391989|OG000|Outcome|Study Group|All patients registered in the study.
10866260|NCT00391989|EG000|Reported Event|Dasatinib|All patients registered in the study.
10866261|NCT00392015|BG000|Baseline|Group 1: NMRC-M3V-Ad-PfCA, 2x10^10 pu|Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10^10 pu and Group 2 received a single high dose of 1x10^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.
10866262|NCT00392015|BG001|Baseline|Group 2: NMRC-M3V-Ad-PfCA,1x10^11 pu|Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10^10 pu and Group 2 received a single high dose of 1x10^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.
10866263|NCT00392015|BG002|Baseline|Group 3: NMRC-M3V-Ad-PfCA, 2x10^10 pu|Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.
10866264|NCT00392015|BG003|Baseline|Group 3: Infectivity Control|Infectivity control subjects were challenged with Group 3 and Group 4
10866265|NCT00392015|BG004|Baseline|Group 4: NMRC-MV-Ad-PfC, 1x10^10 pu|Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.
10866266|NCT00392015|BG005|Baseline|Group 4: Infectivity Control|Infectivity control subjects were challenged with Group 3 and Group 4
10866267|NCT00392015|BG006|Baseline|Total|Total of all reporting groups
10866268|NCT00392015|FG000|Participant Flow|Group 1: NMRC-M3V-Ad-PfCA, 2x10^10 pu|Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10^10 pu and Group 2 received a single high dose of 1x10^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.
10866269|NCT00392015|FG001|Participant Flow|Group 2: NMRC-M3V-Ad-PfCA, 1x10^11 pu|Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10^10 pu and Group 2 received a single high dose of 1x10^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.
10866270|NCT00392015|FG002|Participant Flow|Group 3: NMRC-M3V-Ad-PfCA, 2x10^10 pu|Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.
10866271|NCT00392015|FG003|Participant Flow|Group 3: Infectivity Control|Infectivity control subjects were challenged with Group 3
10866272|NCT00392015|FG004|Participant Flow|Group 4: NMRC-MV-Ad-PfC, 1x10^10 pu|Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.
10866273|NCT00392015|FG005|Participant Flow|Group 4: Infectivity Control|Infectivity control subjects were challenged with Group 4
10866274|NCT00392015|OG000|Outcome|Group 1|Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10^10 pu on Week 0
10866275|NCT00392015|OG001|Outcome|Group 2|Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10^11 pu on Week 4.
10866276|NCT00392015|OG000|Outcome|Group 3|2 doses of NMRC-M3V-Ad-PfCA (2x10^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32
10866277|NCT00392015|OG001|Outcome|Group 4|2 doses of NMRC-MV-Ad-PfC (1x10^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32
10866278|NCT00392015|OG000|Outcome|Group 3|2 doses of NMRC-M3V-Ad-PfCA (2x10^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.
10866279|NCT00392015|OG001|Outcome|Group 3 Infectivity Control|Infectivity control subjects (not vaccinated) were also challenged
10866280|NCT00392015|OG002|Outcome|Group 4|2 doses of NMRC-MV-Ad-PfC (1x10^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.
10866281|NCT00392015|OG003|Outcome|Group 4 Infectivity Control|Infectivity control subjects (not vaccinated) were also challenged
10866282|NCT00392015|OG000|Outcome|Circumsporozoite Protein (CSP)|The NMRC-M3V-Ad-PfCA vaccine combines two adenovectors encoding circumsporozoite protein (CSP) and apical membrane antigen-1 (AMA1)
10866283|NCT00392015|OG001|Outcome|Apical Membrane Antigen-1 (AMA1)|The NMRC-M3V-Ad-PfCA vaccine combines two adenovectors encoding circumsporozoite protein (CSP) and apical membrane antigen-1 (AMA1)
10866284|NCT00392015|OG000|Outcome|Circumsporozoite Protein (CSP)|Synthetic peptides derived from CSP
10866285|NCT00392015|EG000|Reported Event|Group 1|Single low dose (2x10^10 pu) of NMRC-M3V-Ad-PfCA administered intramuscular on Week 0
10866286|NCT00392015|EG001|Reported Event|Group 2|Single high dose (1x10^11 pu) of NMRC-M3V-Ad-PfCA administered intramuscular on Week 4
10866287|NCT00392015|EG002|Reported Event|Group 3|2 doses of NMRC-M3V-Ad-PfCA (2x10^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 2 to 4 weeks after the second immunization.
10866288|NCT00392015|EG003|Reported Event|Group 3 Infectivity Control|Infectivity Control (not vaccinated) were also challenged
10866289|NCT00392015|EG004|Reported Event|Group 4|2 doses of NMRC-MV-Ad-PfC (1x10^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 2 to 4 weeks after the second immunization.
10866290|NCT00392015|EG005|Reported Event|Group 4 Infectivity Control|Infectivity Control (not vaccinated) were also challenged
10866291|NCT00392041|BG000|Baseline|Eszopiclone|Eszopiclone: 3mg qpm for 12 weeks
10866292|NCT00392041|BG001|Baseline|Placebo|placebo: 1 pill qpm for 12 weeks
10866293|NCT00392041|BG002|Baseline|Total|Total of all reporting groups
10866294|NCT00392041|FG000|Participant Flow|Eszopiclone|Eszopiclone: 3mg qpm for 12 weeks
10866295|NCT00392041|FG001|Participant Flow|Placebo|placebo: 1 pill qpm for 12 weeks
10866296|NCT00392041|OG000|Outcome|Eszopiclone|Eszopiclone: 3mg qpm for 12 weeks
10866297|NCT00392041|OG001|Outcome|Placebo|placebo: 1 pill qpm for 12 weeks
10866298|NCT00392041|EG000|Reported Event|Eszopiclone|Eszopiclone: 3mg qpm for 12 weeks
10866299|NCT00392041|EG001|Reported Event|Placebo|placebo: 1 pill qpm for 12 weeks
10866300|NCT00392054|BG000|Baseline|Catheter Ablation|Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation
10866301|NCT00392054|BG001|Baseline|Antiarrhythmic Drug Therapy|Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation
10866302|NCT00392054|BG002|Baseline|Total|Total of all reporting groups
10866303|NCT00392054|FG000|Participant Flow|Catheter Ablation|Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation
10866304|NCT00392054|FG001|Participant Flow|Antiarrhythmic Drug Therapy|Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation
10866305|NCT00392054|OG000|Outcome|Catheter Ablation|First-line treatment with radiofrequency catheter ablation procedure
10866306|NCT00392054|OG001|Outcome|Antiarrhythmic Drug Therapy|Standard antiarrhythmic drug therapy
10866307|NCT00392054|OG000|Outcome|Catheter Ablation|"Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation~Pulmonary Vein Isolation performed by Catheter Ablation: Ablation will be done to achieve entrance block into all pulmonary veins."
10866308|NCT00392054|OG001|Outcome|Antiarrhythmic Drug Therapy|"Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation~Conventional Antiarrhythmic Drug Therapy: Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF"
10866309|NCT00392054|OG000|Outcome|Catheter Ablation|Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation
10866310|NCT00392054|OG001|Outcome|Antiarrhythmic Drug Therapy|Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation
10866311|NCT00392054|EG000|Reported Event|Catheter Ablation|First-line treatment with radiofrequency catheter ablation procedure
10866312|NCT00392054|EG001|Reported Event|Antiarrhythmic Drug Therapy|Standard antiarrhythmic drug therapy
10866313|NCT00392171|BG000|Baseline|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
10866314|NCT00392171|FG000|Participant Flow|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
10866315|NCT00392171|OG000|Outcome|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
10866316|NCT00392171|EG000|Reported Event|Temozolomide|
10866317|NCT00392197|BG000|Baseline|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
10866318|NCT00392197|BG001|Baseline|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
10866319|NCT00392197|BG002|Baseline|Total|Total of all reporting groups
10866320|NCT00392197|FG000|Participant Flow|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
10866321|NCT00392197|FG001|Participant Flow|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
10866322|NCT00392197|OG000|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
10866323|NCT00392197|OG001|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
10866324|NCT00392197|EG000|Reported Event|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
10866325|NCT00392197|EG001|Reported Event|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
10866326|NCT00392210|BG000|Baseline|Auto Fill Followed by Back Fill|The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
10866327|NCT00392210|BG001|Baseline|Back Fill Followed by Auto Fill|The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
10866328|NCT00392210|BG002|Baseline|Total|Total of all reporting groups
10866329|NCT00392210|FG000|Participant Flow|Auto-fill Followed by Back Fill|The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
10866330|NCT00392210|FG001|Participant Flow|Back Fill Followed by Autofill|The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
10866331|NCT00392210|OG000|Outcome|Auto Fill Intervention|Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
10866332|NCT00392210|OG001|Outcome|Back Fill Intervention|Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
10866333|NCT00392210|EG000|Reported Event|Auto Fill|Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
10866334|NCT00392210|EG001|Reported Event|Back Fill|Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
10866335|NCT00392223|BG000|Baseline|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
10866336|NCT00392223|BG001|Baseline|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
10866337|NCT00392223|BG002|Baseline|Total|Total of all reporting groups
10866338|NCT00392223|FG000|Participant Flow|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
10866339|NCT00392223|FG001|Participant Flow|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
10866340|NCT00392223|OG000|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
10866341|NCT00392223|OG001|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
10866342|NCT00392223|EG000|Reported Event|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
10866343|NCT00392223|EG001|Reported Event|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
10866344|NCT00392236|BG000|Baseline|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
10866345|NCT00392236|BG001|Baseline|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
10866346|NCT00392236|BG002|Baseline|Total|Total of all reporting groups
10866347|NCT00392236|FG000|Participant Flow|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
10866348|NCT00392236|FG001|Participant Flow|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual means that study participation does not affect the treatment participants receive in any way. Participants receive whatever treatment they and the clinical team decide upon."
10866349|NCT00392236|OG000|Outcome|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
10866350|NCT00392236|OG001|Outcome|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
10866351|NCT00392236|EG000|Reported Event|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
10866352|NCT00392236|EG001|Reported Event|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
10866353|NCT00392288|BG000|Baseline|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
10866354|NCT00392288|BG001|Baseline|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
10866355|NCT00392288|BG002|Baseline|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
10866356|NCT00392288|BG003|Baseline|Total|Total of all reporting groups
10866357|NCT00392288|FG000|Participant Flow|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
10866358|NCT00392288|FG001|Participant Flow|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
10866359|NCT00392288|FG002|Participant Flow|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
10866360|NCT00392288|OG000|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
10866361|NCT00392288|OG001|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
10866362|NCT00392288|OG002|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
10866363|NCT00392288|EG000|Reported Event|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
10866364|NCT00392288|EG001|Reported Event|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
10866365|NCT00392288|EG002|Reported Event|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
10866366|NCT00392379|BG000|Baseline|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
10866367|NCT00392379|BG001|Baseline|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
10866368|NCT00392379|BG002|Baseline|Total|Total of all reporting groups
10866369|NCT00392379|FG000|Participant Flow|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
10866370|NCT00392379|FG001|Participant Flow|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
10866371|NCT00392379|OG000|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
10866372|NCT00392379|OG001|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
10866373|NCT00392379|EG000|Reported Event|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
10866374|NCT00392379|EG001|Reported Event|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
10866375|NCT00392392|BG000|Baseline|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
10866376|NCT00392392|FG000|Participant Flow|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
10866377|NCT00392392|OG000|Outcome|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
10866378|NCT00392392|EG000|Reported Event|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
10866379|NCT00392444|BG000|Baseline|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
10866380|NCT00392444|FG000|Participant Flow|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
10866381|NCT00392444|OG000|Outcome|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
10866382|NCT00392444|EG000|Reported Event|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
10866383|NCT00392496|BG000|Baseline|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
10866384|NCT00392496|FG000|Participant Flow|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
10866385|NCT00392496|OG000|Outcome|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
10866386|NCT00392496|EG000|Reported Event|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
10866387|NCT00392665|BG000|Baseline|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
10866388|NCT00392665|BG001|Baseline|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
10866389|NCT00392665|BG002|Baseline|Total|Total of all reporting groups
10866390|NCT00392665|FG000|Participant Flow|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
10866391|NCT00392665|FG001|Participant Flow|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
10866392|NCT00392665|OG000|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
10866393|NCT00392665|OG001|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
10866394|NCT00392665|EG000|Reported Event|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
10866395|NCT00392665|EG001|Reported Event|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
10866396|NCT00392678|BG000|Baseline|3 Gram|Salsalate 3.0 g daily, divided
10866397|NCT00392678|BG001|Baseline|3.5 Gram|Salsalate 3.5 g daily, divided
10866398|NCT00392678|BG002|Baseline|4 Gram|Salsalate 4.0 g daily, divided
10866399|NCT00392678|BG003|Baseline|Placebo|matched to active drug
11223179|NCT02351505|OG000|Outcome|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study: Correlative studies"
10866400|NCT00392678|BG004|Baseline|Total|Total of all reporting groups
10866401|NCT00392678|FG000|Participant Flow|3 Gram|Salsalate 3.0 g daily, divided
10866402|NCT00392678|FG001|Participant Flow|3.5 Gram|Salsalate 3.5 g daily, divided
10866403|NCT00392678|FG002|Participant Flow|4 Gram|Salsalate 4.0 g daily, divided
10866404|NCT00392678|FG003|Participant Flow|Placebo|Matched by appearance to active drug
10866405|NCT00392678|OG000|Outcome|3.0 g/d|Salsalate 3.0 g/d, divided
10866406|NCT00392678|OG001|Outcome|3.5 g/d|Salsalate 3.5 g/d, divided
10866407|NCT00392678|OG002|Outcome|4.0 g/d|Salsalate 4.0 g/d, divided
10866408|NCT00392678|OG003|Outcome|Placebo|Placebo matched to active drug
10866409|NCT00392678|OG000|Outcome|Placebo|Placebo matched to active drug
10866410|NCT00392678|OG001|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
10866411|NCT00392678|OG002|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
10866412|NCT00392678|OG003|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
10866413|NCT00392678|OG000|Outcome|Placebo|Placebo matched to active
10866414|NCT00392678|OG000|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
10866415|NCT00392678|OG001|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
10866416|NCT00392678|OG002|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
10866417|NCT00392678|OG003|Outcome|Placebo|Placebo matched to active
10866418|NCT00392678|EG000|Reported Event|Salsalate 3.0 g/d|Active: Salsalate 3.0 g/d
10866419|NCT00392678|EG001|Reported Event|Salsalate 3.5 g/d|Active: Salsalate 3.5 g/d
10866420|NCT00392678|EG002|Reported Event|Salsalate 4.0 g/d|Active: Salsalate 4.0 g/d
10866421|NCT00392678|EG003|Reported Event|Placebo|Identical Placebo
11223180|NCT02351505|OG000|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11223181|NCT02351505|EG000|Reported Event|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10866422|NCT00392704|BG000|Baseline|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
10866423|NCT00392704|FG000|Participant Flow|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
10866424|NCT00392704|OG000|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
10866425|NCT00392704|EG000|Reported Event|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
10866426|NCT00392769|BG000|Baseline|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
10866427|NCT00392769|FG000|Participant Flow|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
10866428|NCT00392769|OG000|Outcome|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
10866429|NCT00392769|EG000|Reported Event|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
10866430|NCT00392782|BG000|Baseline|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
10866431|NCT00392782|FG000|Participant Flow|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
10866432|NCT00392782|OG000|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
10866433|NCT00392782|EG000|Reported Event|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
10866434|NCT00392808|BG000|Baseline|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
10866435|NCT00392808|BG001|Baseline|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
10866436|NCT00392808|BG002|Baseline|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
10866437|NCT00392808|BG003|Baseline|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
10866438|NCT00392808|BG004|Baseline|Total|Total of all reporting groups
10866439|NCT00392808|FG000|Participant Flow|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
10866440|NCT00392808|FG001|Participant Flow|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
10866441|NCT00392808|FG002|Participant Flow|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
10866442|NCT00392808|FG003|Participant Flow|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
10866443|NCT00392808|OG000|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
10866444|NCT00392808|OG001|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
10866445|NCT00392808|OG002|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
10866446|NCT00392808|OG003|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
10866447|NCT00392808|EG000|Reported Event|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
10866448|NCT00392808|EG001|Reported Event|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
10866449|NCT00392808|EG002|Reported Event|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
10866450|NCT00392808|EG003|Reported Event|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
10866451|NCT00392834|BG000|Baseline|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
10866452|NCT00392834|BG001|Baseline|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
10866453|NCT00392834|BG002|Baseline|Total|Total of all reporting groups
10866454|NCT00392834|FG000|Participant Flow|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
10866455|NCT00392834|FG001|Participant Flow|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
10866456|NCT00392834|OG000|Outcome|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
10866457|NCT00392834|OG001|Outcome|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
10866458|NCT00392834|EG000|Reported Event|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
10866459|NCT00392834|EG001|Reported Event|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
10866460|NCT00392925|BG000|Baseline|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866461|NCT00392925|BG001|Baseline|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866462|NCT00392925|BG002|Baseline|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866463|NCT00392925|BG003|Baseline|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
10866464|NCT00392925|BG004|Baseline|Total|Total of all reporting groups
10866465|NCT00392925|FG000|Participant Flow|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
10866466|NCT00392925|FG001|Participant Flow|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 milligram (mg) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
11336520|NCT03567382|OG000|Outcome|High-risk Mothers|"Mothers with high-risk HBV (defined as viral load >10^6 and/or HBeAg positivity) will be treated with tenofovir disoproxil fumarate (TDF) to further reduce the risk of vertical transmission of HBV. All HBV-exposed infants (regardless of mother's status of high- or low-risk HBV) will receive monovalent HBV vaccine within 24 hours of life.~Tenofovir Disoproxil Fumarate: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.~Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life."
11336521|NCT03567382|OG001|Outcome|Low-risk Mothers|"Mothers with low risk HBV (defined as a viral load <10^6 and negative HBeAg) will not receive tenofovir disoproxil fumarate therapy during or after pregnancy. Their infants will still receive monovalent HBV vaccine within 24 hours of life.~Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life."
11336522|NCT03567382|OG000|Outcome|Infants Born to High-risk Mothers|Infants born to mothers with high-risk HBV
11336523|NCT03567382|OG001|Outcome|Infants Born to Low-risk Mothers|Infants born to mothers with low-risk HBV
11336524|NCT03567382|OG000|Outcome|High-risk Mothers|Mothers with high-risk HBV who took tenofovir during pregnancy
11336525|NCT03567382|EG000|Reported Event|High-risk Mothers|"Mothers with high-risk HBV (defined as viral load >10^6 and/or HBeAg positivity) will be treated with tenofovir disoproxil fumarate (TDF) to further reduce the risk of vertical transmission of HBV. All HBV-exposed infants (regardless of mother's status of high- or low-risk HBV) will receive monovalent HBV vaccine within 24 hours of life.~Tenofovir Disoproxil Fumarate: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.~Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life."
10866467|NCT00392925|FG002|Participant Flow|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866468|NCT00392925|FG003|Participant Flow|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866469|NCT00392925|OG000|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866470|NCT00392925|OG001|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866471|NCT00392925|OG002|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866472|NCT00392925|OG001|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866473|NCT00392925|OG002|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866474|NCT00392925|OG002|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866475|NCT00392925|OG000|Outcome|Lead-In Participants Randomized to Treatment on Day 1|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to a treatment group.
10866476|NCT00392925|OG002|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
11336526|NCT03567382|EG001|Reported Event|Low-risk Mothers|"Mothers with low risk HBV (defined as a viral load <10^6 and negative HBeAg) will not receive tenofovir disoproxil fumarate therapy during or after pregnancy. Their infants will still receive monovalent HBV vaccine within 24 hours of life.~Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life."
11336527|NCT03567382|EG002|Reported Event|Infants Born to High-risk Mothers|Infants born to mothers with high-risk HBV
11336528|NCT03567382|EG003|Reported Event|Infants Born to Low-risk Mothers|Infants born to mothers with low-risk HBV
10866477|NCT00392925|OG003|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
10866478|NCT00392925|OG003|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
10866479|NCT00392925|EG000|Reported Event|Placebo + Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866480|NCT00392925|EG001|Reported Event|Pramlintide + Placebo|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
10866481|NCT00392925|EG002|Reported Event|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
11336529|NCT03567616|BG000|Baseline|Participants Positive for t(11;14) Translocation|Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
11336530|NCT03567616|BG001|Baseline|Participants Negative for t(11;14) Translocation|Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
11336531|NCT03567616|BG002|Baseline|Total|Total of all reporting groups
10866482|NCT00392925|EG003|Reported Event|Participants Not Randomized to Group After Lead-In Period|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
10866483|NCT00392951|BG000|Baseline|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
10866484|NCT00392951|FG000|Participant Flow|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
10866485|NCT00392951|OG000|Outcome|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
10866486|NCT00392951|EG000|Reported Event|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
10866487|NCT00392990|BG000|Baseline|High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles|"Patients are stratified between high risk and low risk disease status.~High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.~Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen"
10866488|NCT00392990|BG001|Baseline|Low Risk - Treatment With 3 Cycles of R-CODOX-M|"Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A).~Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen~Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses) 4 doses)"
10866489|NCT00392990|BG002|Baseline|Total|Total of all reporting groups
10866490|NCT00392990|FG000|Participant Flow|Low Risk - Treatment With 3 Cycles of R-CODOX-M|"Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A).~Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen~Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)"
10866491|NCT00392990|FG001|Participant Flow|High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles|"Patients are stratified between high risk and low risk disease status.~High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.~Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen~Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)"
10866492|NCT00392990|OG000|Outcome|High Risk - Treated With Alternating R-CODOX-M/R-IVAC|"Patients are stratified between high risk and low risk disease status.~High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.~Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen~Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)"
10866493|NCT00392990|OG001|Outcome|Low Risk - Treatment With 3 Cycles of R-CODOX-M|"Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A).~Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen~Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)"
10866494|NCT00392990|EG000|Reported Event|High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles|"Patients are stratified between high risk and low risk disease status.~High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.~Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen~Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)"
10879153|NCT00455741|BG001|Baseline|Older PMW|"Postmenopausal women (PMW) ages 70-80 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10879154|NCT00455741|BG002|Baseline|Total|Total of all reporting groups
10866495|NCT00392990|EG001|Reported Event|Low Risk - Treatment With 3 Cycles of R-CODOX-M|"Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A).~Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen~Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)"
10866496|NCT00393029|BG000|Baseline|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
10866497|NCT00393029|BG001|Baseline|Other Metastatic Cancers|
10866498|NCT00393029|BG002|Baseline|Total|Total of all reporting groups
10866499|NCT00393029|FG000|Participant Flow|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
10866500|NCT00393029|FG001|Participant Flow|Other Metastatic Cancers|
10866501|NCT00393029|OG000|Outcome|Metastatic Melanoma & Other Metastatic Cancers|"Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).~There are no statistical differences between the arms, therefore, they can be combined for this outcome measure."
10866502|NCT00393029|OG000|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
10866503|NCT00393029|OG001|Outcome|Other Metastatic Cancers|
10866504|NCT00393029|EG000|Reported Event|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
10866505|NCT00393029|EG001|Reported Event|Other Metastatic Cancers|
10866506|NCT00393042|BG000|Baseline|Overall Study|Participants either Adderall XR or Focalin XR for four weeks (3 dose levels and placebo) followed by four weeks (3 dose levels and placebo) of the opposite medication they received the first four weeks. Baseline Measures are based off all participants that were randomized regardless of the order they received the medication. Since we were interested in evaluating efficacy and adverse events at all dose conditions, participants were included in analysis if they received at least 2 weeks of study drug to insure that all participants had been exposed to at least one week of active drug
10866507|NCT00393042|FG000|Participant Flow|Focalin XR Then Adderall XR|Focalin XR first for 4 weeks (3 dose levels and placebo) then Adderall XR for 4 weeks (3 dose levels and placebo).
10866508|NCT00393042|FG001|Participant Flow|Adderall XR Then Focalin XR|Adderall XR first for 4 weeks (3 dose levels and placebo) then Focalin XR for 4 weeks (3 dose levels and placebo).
10866509|NCT00393042|OG000|Outcome|Placebo|Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
10866510|NCT00393042|OG001|Outcome|10mg of Either Focalin XR or Adderall XR|Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
10866511|NCT00393042|OG002|Outcome|20mg of Either Focalin XR or Adderall XR|Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
10866512|NCT00393042|OG003|Outcome|25/30mg of Either Focalin XR or Adderall XR|Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
10866513|NCT00393042|OG004|Outcome|Adderall XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
10866514|NCT00393042|OG005|Outcome|Focalin XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
10866515|NCT00393042|OG002|Outcome|20 mg of Either Focalin XR or Adderall XR|Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
10866516|NCT00393042|OG003|Outcome|25/30mg of Either Focalin XR or Adderall XR|Each participant received 25/30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
10866517|NCT00393042|OG000|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
10866518|NCT00393042|OG001|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
10866519|NCT00393042|OG002|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
10866520|NCT00393042|OG003|Outcome|Adderall XR - 25/30mg|This is the 25/30 mg dosage week for the Adderall XR medication.
10866521|NCT00393042|OG004|Outcome|Focalin XR - Placebo|This is the placebo dosage week for the Focalin XR medication.
10866522|NCT00393042|OG005|Outcome|Focalin XR - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
10866523|NCT00393042|OG006|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
10866524|NCT00393042|OG007|Outcome|Focalin XR - 25/30mg|This is the 25/30 mg dosage week for the Focalin XR medication.
10866525|NCT00393042|OG000|Outcome|9/9 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/9 allele
10866526|NCT00393042|OG001|Outcome|9/9 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
10866527|NCT00393042|OG002|Outcome|9/9 Allele: 20 mg Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
10866528|NCT00393042|OG003|Outcome|9/9 Allele: 25/30mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
10866529|NCT00393042|OG004|Outcome|9/9 Allele: Placebo of Focalin XR|This is the placebo dosage of Focalin XR medication phase for the participants with the 9/9 allele
10866530|NCT00393042|OG005|Outcome|9/9 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
10866531|NCT00393042|OG006|Outcome|9/9 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
10866532|NCT00393042|OG007|Outcome|9/9 Allele: 25/30 mg of Focalin XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
10866533|NCT00393042|OG008|Outcome|9/10 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele
10866534|NCT00393042|OG009|Outcome|9/10 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
10866535|NCT00393042|OG010|Outcome|9/10 Allele: 20 mg of Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
10866536|NCT00393042|OG011|Outcome|9/10 Allele: 25/30 mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
10866537|NCT00393042|OG012|Outcome|9/10 Allele: Placebo of Focalin XR|This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele
10866538|NCT00393042|OG013|Outcome|9/10 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
10866539|NCT00393042|OG014|Outcome|9/10 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
10866540|NCT00393042|OG015|Outcome|9/10 Allele: 25/30 mg of Focalin XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
10866541|NCT00393042|OG016|Outcome|10/10 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele
10866542|NCT00393042|OG017|Outcome|10/10 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
10866543|NCT00393042|OG018|Outcome|10/10 Allele: 20 mg of Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
10866544|NCT00393042|OG019|Outcome|10/10 Allele: 25/30 mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
10866545|NCT00393042|OG020|Outcome|10/10 Allele: Placebo of Focalin XR|This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele
11336532|NCT03567616|FG000|Participant Flow|All Participants|Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
10866546|NCT00393042|OG021|Outcome|10/10 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
10866547|NCT00393042|OG022|Outcome|10/10 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
10866548|NCT00393042|OG023|Outcome|10/10 Allele: 25/30mg of Focaling XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
10866549|NCT00393042|OG003|Outcome|Adderall XR - 25/30 mg|This is the 25/30 mg dosage week for the Adderall XR medication.
10866550|NCT00393042|OG005|Outcome|Focalin - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
10866551|NCT00393042|OG007|Outcome|Focalin XR - 25/30 mg|This is the 25/30 mg dosage week for the Focalin XR medication.
10866552|NCT00393042|OG004|Outcome|Focalin XR - Placebo|This is the Placebo dosage week for the Focalin XR medication.
10866553|NCT00393042|EG000|Reported Event|Placebo of Focalin XR|Each participant recieved placebo of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
10866554|NCT00393042|EG001|Reported Event|10mg of Focalin XR|Each participant recieved 10 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
10866555|NCT00393042|EG002|Reported Event|20 mg of Focalin XR|Each participant recieved 20 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
10866556|NCT00393042|EG003|Reported Event|25/30mg of Focalin XR|Each participant recieved 25/30 mg (depending on weight) of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
10866557|NCT00393042|EG004|Reported Event|Placebo of Adderall XR|Each participant recieved placebo of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
10866558|NCT00393042|EG005|Reported Event|10mg of Adderall XR|Each participant recieved 10 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
11336533|NCT03567616|OG000|Outcome|Participants Positive for t(11;14) Translocation|Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
10866559|NCT00393042|EG006|Reported Event|20 mg of Adderall XR|Each participant recieved 20 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
10866560|NCT00393042|EG007|Reported Event|25/30mg of Adderall XR|Each participant recieved 25/30 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
10879155|NCT00455741|FG000|Participant Flow|Younger PMW|"Postmenopausal women (PMW) ages 45-55 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10879156|NCT00455741|FG001|Participant Flow|Older PMW|"Postmenopausal women (PMW) ages 70-80 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10879157|NCT00455741|OG000|Outcome|Younger PMW|"Postmenopausal women (PMW) ages 45-55 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10866561|NCT00393094|BG000|Baseline|Enrollment Until Prior to Treatment|
10866562|NCT00393094|FG000|Participant Flow|Enrollment Until Prior to Treatment|
10866563|NCT00393094|OG000|Outcome|Enrollment Until Prior to Treatment|
10866564|NCT00393094|OG000|Outcome|Bevacizumab & Irinotecan Anaplastic Glioma Pts: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Anaplastic gliomas are classified by the World Health Organization (WHO) as grade 3 malignant tumors and include the anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma or mixed glioma.
10866565|NCT00393094|OG000|Outcome|Bevacizumab & Irinotecan Glioblastoma Multiforme: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Glioblastoma multiforme- is a fast growing type of central nervous system tumor that forms from glial (supportive) tissue of the brain and spinal cord and has cells that look very different from normal cells. Glioblastoma multiforme usually occurs in adults and affects the brain more often than the spinal cord. Also called GBM, glioblastoma, and grade IV astrocytoma.
10866566|NCT00393094|EG000|Reported Event|Enrollment Until Prior to Treatment|
10866567|NCT00393367|BG000|Baseline|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
11348152|NCT04207333|FG000|Participant Flow|Prolonged Sitting + Mental Stress, Then Brief Sitting + Mental Stress|"Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test. Following a 2-7 day wash-out period, participants will be exposed to the other condition (brief sitting, followed by mental stress). For this condition participants will rest in the supine position for 10 minutes, then will be switched to an upright seated position. Following the 10 minutes quiet rest in the seated position, participants will be subjected to a 5 minute mental arithmetic test.~Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes"
11348153|NCT04207333|FG001|Participant Flow|Brief Sitting + Mental Stress, Then Prolonged Sitting + Mental Stress|"Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test. Following a 2-7 day wash-out period, participants will be exposed to the other condition (prolonged sitting, followed by mental stress). For this condition participants will rest in the supine position for 10 minutes, then will be switched to an upright seated position. Participants will sit quietly for 120 min while watching a documentary, following which the participants will be subjected to a 5 minute mental arithmetic test.~Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes"
11348154|NCT04207333|OG000|Outcome|Prolonged Sitting With Mental Stress|"Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.~Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes"
11348155|NCT04207333|OG001|Outcome|Brief Sitting With Mental Stress|"Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.~Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes"
11348756|NCT04136444|FG000|Participant Flow|Cohort A|Healthy study participants in Cohort A received a single dose of padsevonil 100 milligrams (mg) on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg twice daily (bid) from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
10866568|NCT00393367|BG001|Baseline|Placebo (Saline)|standardized treatment with nebulized saline
10866569|NCT00393367|BG002|Baseline|Total|Total of all reporting groups
10866570|NCT00393367|FG000|Participant Flow|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
10866571|NCT00393367|FG001|Participant Flow|Placebo (Saline)|standardized treatment with nebulized saline
10866572|NCT00393367|OG000|Outcome|Budesonide Inhalation Suspension (BIS)|
10866573|NCT00393367|OG001|Outcome|Placebo (Normal Saline)|
10866574|NCT00393367|OG000|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
10866575|NCT00393367|OG001|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
10866576|NCT00393367|EG000|Reported Event|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
10866577|NCT00393367|EG001|Reported Event|Placebo (Saline)|standardized treatment with nebulized saline
10866578|NCT00393380|BG000|Baseline|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
10866579|NCT00393380|FG000|Participant Flow|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
10866580|NCT00393380|OG000|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
10866581|NCT00393380|EG000|Reported Event|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
10866582|NCT00393458|BG000|Baseline|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866583|NCT00393458|BG001|Baseline|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866584|NCT00393458|BG002|Baseline|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866585|NCT00393458|BG003|Baseline|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866586|NCT00393458|BG004|Baseline|Total|Total of all reporting groups
10866587|NCT00393458|FG000|Participant Flow|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11224525|NCT02360488|OG000|Outcome|Telerehabilitation Therapy|"The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.~Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions."
10866588|NCT00393458|FG001|Participant Flow|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866589|NCT00393458|FG002|Participant Flow|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866590|NCT00393458|FG003|Participant Flow|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10879158|NCT00455741|OG001|Outcome|Older PMW|"Postmenopausal women (PMW) ages 70-80 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10866591|NCT00393458|OG000|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866592|NCT00393458|OG001|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866593|NCT00393458|OG002|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866594|NCT00393458|OG003|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866595|NCT00393458|EG000|Reported Event|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866596|NCT00393458|EG001|Reported Event|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866597|NCT00393458|EG002|Reported Event|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866598|NCT00393458|EG003|Reported Event|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10866599|NCT00393484|BG000|Baseline|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
10866600|NCT00393484|BG001|Baseline|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
10866601|NCT00393484|BG002|Baseline|Total|Total of all reporting groups
10866602|NCT00393484|FG000|Participant Flow|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
10866603|NCT00393484|FG001|Participant Flow|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
10866604|NCT00393484|OG000|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
11336534|NCT03567616|OG001|Outcome|Participants Negative for t(11;14) Translocation|Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
10866605|NCT00393484|OG001|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
10866606|NCT00393484|OG001|Outcome|Lamivudine, 100 mg+ Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
10866607|NCT00393484|OG001|Outcome|Lamivudine, 100 mg|Participants received lamivudine, 100 mg, once daily for up to 240 weeks
10866608|NCT00393484|EG000|Reported Event|Entecavir , 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
10866609|NCT00393484|EG001|Reported Event|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
10866610|NCT00393510|BG000|Baseline|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
10866611|NCT00393510|BG001|Baseline|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
10866612|NCT00393510|BG002|Baseline|Total|Total of all reporting groups
10866613|NCT00393510|FG000|Participant Flow|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
10866614|NCT00393510|FG001|Participant Flow|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
10866615|NCT00393510|OG000|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
10866616|NCT00393510|OG001|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
10866617|NCT00393510|EG000|Reported Event|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
10866618|NCT00393510|EG001|Reported Event|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
10866619|NCT00393523|BG000|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
10866620|NCT00393523|BG001|Baseline|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
10866621|NCT00393523|BG002|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
10866622|NCT00393523|BG003|Baseline|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
10866623|NCT00393523|BG004|Baseline|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
10866624|NCT00393523|BG005|Baseline|Total|Total of all reporting groups
10866625|NCT00393523|FG000|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
10866626|NCT00393523|FG001|Participant Flow|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
10866627|NCT00393523|FG002|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
10866628|NCT00393523|FG003|Participant Flow|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
10866629|NCT00393523|FG004|Participant Flow|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
10866630|NCT00393523|OG000|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
10866631|NCT00393523|OG001|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
10866632|NCT00393523|OG000|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
10866633|NCT00393523|OG001|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
10866634|NCT00393523|EG000|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
10866635|NCT00393523|EG001|Reported Event|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
10866636|NCT00393523|EG002|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
10866637|NCT00393523|EG003|Reported Event|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
10866638|NCT00393523|EG004|Reported Event|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
10866639|NCT00393705|BG000|Baseline|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
10866640|NCT00393705|BG001|Baseline|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
10866641|NCT00393705|BG002|Baseline|Total|Total of all reporting groups
10866642|NCT00393705|FG000|Participant Flow|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
11336535|NCT03567616|OG002|Outcome|All Participants|Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
10866643|NCT00393705|FG001|Participant Flow|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
10866644|NCT00393705|OG000|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
10866645|NCT00393705|OG001|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
10866646|NCT00393705|EG000|Reported Event|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
10866647|NCT00393705|EG001|Reported Event|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
10866648|NCT00393718|BG000|Baseline|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
10866649|NCT00393718|BG001|Baseline|Glibenclamide|Glibenclamide 1.25-2.5 mg + liraglutide placebo
10866650|NCT00393718|BG002|Baseline|Total|Total of all reporting groups
10866651|NCT00393718|FG000|Participant Flow|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
10866652|NCT00393718|FG001|Participant Flow|Glibenclamide|Glibenclamide 1.25-2.5 mg + liraglutide placebo
10866653|NCT00393718|OG000|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
10866654|NCT00393718|OG001|Outcome|Glibenclamide|Glibenclamide 1.25-2.5 mg + liraglutide placebo
10866655|NCT00393718|EG000|Reported Event|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
10866656|NCT00393718|EG001|Reported Event|Glibenclamide|Glibenclamide 1.25-2.5 mg + liraglutide placebo
10866657|NCT00393796|BG000|Baseline|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
10866658|NCT00393796|BG001|Baseline|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
10866659|NCT00393796|BG002|Baseline|Total|Total of all reporting groups
10866660|NCT00393796|FG000|Participant Flow|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
10866661|NCT00393796|FG001|Participant Flow|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
10866662|NCT00393796|OG000|Outcome|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
10866663|NCT00393796|OG001|Outcome|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
10866664|NCT00393796|EG000|Reported Event|SUTENT|"Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.~26 participants were randomized to SUTENT and 16 participants randomized to Placebo crossed over to SUTENT during treatment so a total of 42 participants were treated with SUTENT."
10866665|NCT00393796|EG001|Reported Event|Placebo Only|"Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.~28 participants were randomized to Placebo. 16 of these 28 patients later received SUTENT."
10866666|NCT00393848|BG000|Baseline|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
10866667|NCT00393848|BG001|Baseline|Experiment 1 - Standard of Care|Usual clinical care - no dietary intervention.
10866668|NCT00393848|BG002|Baseline|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
10866669|NCT00393848|BG003|Baseline|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
10866670|NCT00393848|BG004|Baseline|Total|Total of all reporting groups
10866671|NCT00393848|FG000|Participant Flow|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
10866672|NCT00393848|FG001|Participant Flow|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
10866673|NCT00393848|FG002|Participant Flow|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
10866674|NCT00393848|FG003|Participant Flow|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
10866675|NCT00393848|OG000|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
10866676|NCT00393848|OG001|Outcome|Experiment 1 - Standard of Care|Usual clinical care without dietary intervention
10866677|NCT00393848|OG002|Outcome|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
10866678|NCT00393848|OG003|Outcome|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
10866679|NCT00393848|OG001|Outcome|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
10866680|NCT00393848|EG000|Reported Event|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement: 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
10866681|NCT00393848|EG001|Reported Event|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
10866682|NCT00393848|EG002|Reported Event|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
10866683|NCT00393848|EG003|Reported Event|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
10866684|NCT00393861|BG000|Baseline|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
10866685|NCT00393861|FG000|Participant Flow|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
11336365|NCT03565315|OG003|Outcome|Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg each) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
10866686|NCT00393861|OG000|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
10866687|NCT00393861|EG000|Reported Event|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
10866688|NCT00393874|BG000|Baseline|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
10866689|NCT00393874|BG001|Baseline|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
10866690|NCT00393874|BG002|Baseline|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
10866691|NCT00393874|BG003|Baseline|Total|Total of all reporting groups
10866692|NCT00393874|FG000|Participant Flow|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
10866693|NCT00393874|FG001|Participant Flow|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
10866694|NCT00393874|FG002|Participant Flow|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
10866695|NCT00393874|OG000|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
10866696|NCT00393874|OG001|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
10866697|NCT00393874|OG002|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
10866698|NCT00393874|OG000|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.~Prazosin: Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal"
10866699|NCT00393874|OG001|Outcome|Behavioral|"Participants randomized to BSI receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
11126386|NCT01733069|FG001|Participant Flow|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
11336366|NCT03565315|OG004|Outcome|Overall|Total number of participants who received 10E8VLS administered alone or concurrently with VRC07-523LS
10866700|NCT00393874|OG002|Outcome|Placebo|"Participants randomized to PLA take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.~Placebo: Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medicat"
10866701|NCT00393874|EG000|Reported Event|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.~Prazosin: Participants randomized to PRZ took 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin was 10 mg. Some individuals required doses up to 15 mg."
10866702|NCT00393874|EG001|Reported Event|Behavioral|"Participants randomized to BSI received the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment was administered over 8 weeks. The intervention sessions consisted of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session was conducted on Week 5. Thirty-minute face-to-face contacts were scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that had occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
10866703|NCT00393874|EG002|Reported Event|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.~Placebo: Participants randomized to PLA took 4 capsules each night for eight weeks, all capsules were identical to prazosin capsules. They received a one-week medication."
10866704|NCT00393887|BG000|Baseline|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
10866705|NCT00393887|BG001|Baseline|Polypropylene Mesh|Synthetic polypropylene mesh
10866706|NCT00393887|BG002|Baseline|Total|Total of all reporting groups
10866707|NCT00393887|FG000|Participant Flow|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
10866708|NCT00393887|FG001|Participant Flow|Polypropylene Mesh|Synthetic polypropylene mesh
10866709|NCT00393887|OG000|Outcome|Biodesign IHM Graft|Inguinal hernia repair with Biodesign Inguinal Hernia Matrix (IHM)
10866710|NCT00393887|OG001|Outcome|Polypropylene Mesh|Inguinal hernia repair with Polypropylene mesh
10866711|NCT00393887|EG000|Reported Event|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
10866712|NCT00393887|EG001|Reported Event|Polypropylene Mesh|Synthetic polypropylene mesh
10866713|NCT00393913|BG000|Baseline|Sleep Apnea Assessment|All participants were assigned to a single Arm (and received the intervention based on whether they had sleep apnea). Participants with sleep apnea used the CPAP machine for 4 to 6 weeks every night and then returned to the sleep laboratory for assessment of daytime function. Those without sleep apnea will have the initial assessment but then will not receive the intervention.
10866714|NCT00393913|FG000|Participant Flow|CPAP|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
10866715|NCT00393913|OG000|Outcome|Sleep Apnea|All participants with obstructive sleep apnea (and no other sleep disorder) and subjects without sleep apnea.
10866716|NCT00393913|OG000|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
10866717|NCT00393913|EG000|Reported Event|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
10866718|NCT00393939|BG000|Baseline|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
10866719|NCT00393939|BG001|Baseline|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
10866720|NCT00393939|BG002|Baseline|Total|Total of all reporting groups
10866721|NCT00393939|FG000|Participant Flow|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
10866722|NCT00393939|FG001|Participant Flow|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
10866723|NCT00393939|OG000|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
10866724|NCT00393939|OG001|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
10866725|NCT00393939|EG000|Reported Event|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
10866726|NCT00393939|EG001|Reported Event|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
10866727|NCT00393978|BG000|Baseline|Quitiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
10866728|NCT00393978|BG001|Baseline|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
10866729|NCT00393978|BG002|Baseline|Total|Total of all reporting groups
10866730|NCT00393978|FG000|Participant Flow|Quitiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
10866731|NCT00393978|FG001|Participant Flow|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
10866732|NCT00393978|OG000|Outcome|Quitiapine and Placebo|"Quetiapine and Placebo~Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
10866733|NCT00393978|OG001|Outcome|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
10866734|NCT00393978|EG000|Reported Event|Quitiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
10866735|NCT00393978|EG001|Reported Event|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
10866736|NCT00394082|BG000|Baseline|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
10866737|NCT00394082|FG000|Participant Flow|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
11336536|NCT03567616|EG000|Reported Event|Participants Positive for t(11;14) Translocation|Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
10866738|NCT00394082|OG000|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
10866739|NCT00394082|EG000|Reported Event|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
10866740|NCT00394095|BG000|Baseline|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
10866741|NCT00394095|BG001|Baseline|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
10866742|NCT00394095|BG002|Baseline|Total|Total of all reporting groups
10866743|NCT00394095|FG000|Participant Flow|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
10866744|NCT00394095|FG001|Participant Flow|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
10866745|NCT00394095|OG000|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
10866746|NCT00394095|OG001|Outcome|Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
10866747|NCT00394095|OG001|Outcome|Comparator Group: Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
10866748|NCT00394095|EG000|Reported Event|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
10866749|NCT00394095|EG001|Reported Event|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
10866750|NCT00394212|BG000|Baseline|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
10866751|NCT00394212|BG001|Baseline|Sham Endoscopy|Sham Endoscopy (suturing not performed)
10866752|NCT00394212|BG002|Baseline|Total|Total of all reporting groups
10866753|NCT00394212|FG000|Participant Flow|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
10866754|NCT00394212|FG001|Participant Flow|Sham Endoscopy|Sham Endoscopy (suturing not performed)
10866755|NCT00394212|OG000|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
10866756|NCT00394212|OG001|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
10866757|NCT00394212|EG000|Reported Event|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
10866758|NCT00394212|EG001|Reported Event|Sham Endoscopy|Sham Endoscopy (suturing not performed)
10866759|NCT00394251|BG000|Baseline|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866760|NCT00394251|BG001|Baseline|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866761|NCT00394251|BG002|Baseline|Total|Total of all reporting groups
10866762|NCT00394251|FG000|Participant Flow|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866763|NCT00394251|FG001|Participant Flow|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866764|NCT00394251|OG000|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866765|NCT00394251|OG001|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866766|NCT00394251|OG000|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
10866767|NCT00394251|OG001|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866768|NCT00394251|OG002|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
10866769|NCT00394251|OG003|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866770|NCT00394251|EG000|Reported Event|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866771|NCT00394251|EG001|Reported Event|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
10866772|NCT00394277|BG000|Baseline|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
10866773|NCT00394277|BG001|Baseline|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
10866774|NCT00394277|BG002|Baseline|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
10866775|NCT00394277|BG003|Baseline|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
10866776|NCT00394277|BG004|Baseline|Total|Total of all reporting groups
10866777|NCT00394277|FG000|Participant Flow|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
10866778|NCT00394277|FG001|Participant Flow|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
10866779|NCT00394277|FG002|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
10866780|NCT00394277|FG003|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
10866781|NCT00394277|OG000|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
10866782|NCT00394277|OG001|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
10866783|NCT00394277|OG002|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
10866784|NCT00394277|OG003|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
10866785|NCT00394277|EG000|Reported Event|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
10866786|NCT00394277|EG001|Reported Event|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
10866787|NCT00394277|EG002|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
10866788|NCT00394277|EG003|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
10866789|NCT00394329|BG000|Baseline|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866790|NCT00394329|BG001|Baseline|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866791|NCT00394329|BG002|Baseline|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866792|NCT00394329|BG003|Baseline|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866793|NCT00394329|BG004|Baseline|Total|Total of all reporting groups
10866794|NCT00394329|FG000|Participant Flow|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866795|NCT00394329|FG001|Participant Flow|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866796|NCT00394329|FG002|Participant Flow|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866797|NCT00394329|FG003|Participant Flow|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866798|NCT00394329|OG000|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866799|NCT00394329|OG001|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
11336537|NCT03567616|EG001|Reported Event|Participants Negative for t(11;14) Translocation|Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
10866800|NCT00394329|OG002|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866801|NCT00394329|OG003|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866802|NCT00394329|OG000|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866803|NCT00394329|OG001|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866804|NCT00394329|OG000|Outcome|Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866805|NCT00394329|OG001|Outcome|Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866806|NCT00394329|OG002|Outcome|Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866807|NCT00394329|OG003|Outcome|Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866808|NCT00394329|EG000|Reported Event|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866809|NCT00394329|EG001|Reported Event|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866810|NCT00394329|EG002|Reported Event|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
10866811|NCT00394329|EG003|Reported Event|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
10866812|NCT00394433|BG000|Baseline|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
10866813|NCT00394433|FG000|Participant Flow|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
11336538|NCT03567980|BG000|Baseline|Topical Crisaborole 2%|Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
10866814|NCT00394433|OG000|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
10866815|NCT00394433|EG000|Reported Event|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
10866816|NCT00394472|BG000|Baseline|AZD3355|AZD3355 capsules 65 mg bid
10866817|NCT00394472|BG001|Baseline|Placebo|Placebo capsules bid
10866818|NCT00394472|BG002|Baseline|Total|Total of all reporting groups
10866819|NCT00394472|FG000|Participant Flow|AZD3355|AZD3355 capsules 65 mg bid
10866820|NCT00394472|FG001|Participant Flow|Placebo|Placebo capsules bid
10866821|NCT00394472|OG000|Outcome|AZD3355|AZD3355 capsules 65 mg bid
10866822|NCT00394472|OG001|Outcome|Placebo|Placebo capsules bid
10866823|NCT00394472|EG000|Reported Event|AZD3355|AZD3355 capsules 65 mg bid
10866824|NCT00394472|EG001|Reported Event|Placebo|Placebo capsules bid
10866825|NCT00394524|BG000|Baseline|Glucommander|insulin infusion per Glucommander
10866826|NCT00394524|BG001|Baseline|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
10866827|NCT00394524|BG002|Baseline|Total|Total of all reporting groups
10866828|NCT00394524|FG000|Participant Flow|Glucommander|continuous insulin infusion per Glucommander, a computer-guided device; dosage or rate of insulin per algorithm
10866829|NCT00394524|FG001|Participant Flow|Standard Insulin Infusion|standard continuous insulin infusion with columnar algorithm; dosage or rate of insulin per algorithm
10866830|NCT00394524|OG000|Outcome|Glucommander|insulin infusion per Glucommander
10866831|NCT00394524|OG001|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
10866832|NCT00394524|OG000|Outcome|Computer Assisted IV Insulin Infusion|"Subjects in this group will receive continuous intravenous (IV) Insulin Infusion using glucommander computer guided system. All patients in the study will receive Glulisine(Apidra R ) a rapid acting insulin approved by Food and Drug Administration (FDA)~Glucommander: Glucommander is a Computer-guided Intravenous (IV) insulin infusion protocol used for glycemic control in inpatients. This algorithm directs the administration of IV insulin in response to Blood Glucose (BG) measurement at the patient's bedside. In this study, the Glucommander program was loaded into a PalmOne handheld personal digital assistant (PDA) device. During the infusion, the nurse entered BG levels into the system and the computer recommended the insulin infusion rate and a variable time to check the next glucose testing. An alarm prompted the scheduled glucose check. The insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG- 60)."
10866833|NCT00394524|OG001|Outcome|Standard Insulin Infusion Algorithm|"Subjects in this group will receive Insulin using Standard insulin infusion algorithm. All patients in the study will receive Glulisine(Apidra R ) a rapid acting insulin approved by Food and Drug Administration (FDA)~Standard insulin infusion Algorithm is a standard paper form insulin infusion algorithm. The algorithm is divided into four columns based on empirically determined insulin sensitivity. The first column was for the most insulin-sensitive patients, and the fourth column was for the most insulin resistant patients. The majority of patients are started in the algorithm 1 column. Insulin resistant patients, such as those receiving glucocorticoids or receiving >80 units of insulin per day as outpatients, started in the algorithm 2 column. The insulin infusion rate was determined by the patient's BG level and was measured hourly until the patient was stable and within the target range."
10866834|NCT00394524|EG000|Reported Event|Glucommander|insulin infusion per Glucommander
10866835|NCT00394524|EG001|Reported Event|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
10866836|NCT00394589|BG000|Baseline|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
10866837|NCT00394589|BG001|Baseline|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
10866838|NCT00394589|BG002|Baseline|Control|Continuation of infliximab 3 mg/kg every 8 weeks
10866839|NCT00394589|BG003|Baseline|Total|Total of all reporting groups
10866840|NCT00394589|FG000|Participant Flow|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
10866841|NCT00394589|FG001|Participant Flow|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
10866842|NCT00394589|FG002|Participant Flow|Control|Continuation of infliximab 3 mg/kg every 8 weeks
10866843|NCT00394589|OG000|Outcome|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
10866844|NCT00394589|OG001|Outcome|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
10866845|NCT00394589|OG002|Outcome|Control|Continuation of infliximab 3 mg/kg every 8 weeks
10866846|NCT00394589|EG000|Reported Event|Infliximab*3mg/kg+1*Vial Q8W|
10866847|NCT00394589|EG001|Reported Event|Infliximab*3mg/kg Q6W|
10866848|NCT00394589|EG002|Reported Event|Control*Infliximab*3mg/kg Q8W|
10866849|NCT00394654|BG000|Baseline|PLACEBO|
10866850|NCT00394654|BG001|Baseline|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
10866851|NCT00394654|BG002|Baseline|Total|Total of all reporting groups
10866852|NCT00394654|FG000|Participant Flow|PLACEBO|
10866853|NCT00394654|FG001|Participant Flow|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
10866854|NCT00394654|OG000|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
10866855|NCT00394654|OG001|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
10866856|NCT00394654|EG000|Reported Event|PLACEBO|
10866857|NCT00394654|EG001|Reported Event|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
10866858|NCT00394706|BG000|Baseline|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
10866859|NCT00394706|BG001|Baseline|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
10866860|NCT00394706|BG002|Baseline|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
10866861|NCT00394706|BG003|Baseline|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
10866862|NCT00394706|BG004|Baseline|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
10866863|NCT00394706|BG005|Baseline|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
10866864|NCT00394706|BG006|Baseline|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
10866865|NCT00394706|BG007|Baseline|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
10866866|NCT00394706|BG008|Baseline|Total|Total of all reporting groups
10866867|NCT00394706|FG000|Participant Flow|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
10866868|NCT00394706|FG001|Participant Flow|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
10866869|NCT00394706|FG002|Participant Flow|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
10866870|NCT00394706|FG003|Participant Flow|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
10866871|NCT00394706|FG004|Participant Flow|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
10866872|NCT00394706|FG005|Participant Flow|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
10866873|NCT00394706|FG006|Participant Flow|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
10866874|NCT00394706|FG007|Participant Flow|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
10866875|NCT00394706|OG000|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
10866876|NCT00394706|OG001|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
10866877|NCT00394706|OG002|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
10866878|NCT00394706|OG003|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
10866879|NCT00394706|EG000|Reported Event|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
10866880|NCT00394706|EG001|Reported Event|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
10866881|NCT00394706|EG002|Reported Event|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
10866882|NCT00394706|EG003|Reported Event|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
10866883|NCT00394706|EG004|Reported Event|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
10866884|NCT00394706|EG005|Reported Event|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
10866885|NCT00394706|EG006|Reported Event|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
10866886|NCT00394706|EG007|Reported Event|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
10866887|NCT00394771|BG000|Baseline|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866888|NCT00394771|BG001|Baseline|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866889|NCT00394771|BG002|Baseline|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866890|NCT00394771|BG003|Baseline|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
10866891|NCT00394771|BG004|Baseline|Total|Total of all reporting groups
10866892|NCT00394771|FG000|Participant Flow|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866893|NCT00394771|FG001|Participant Flow|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866894|NCT00394771|FG002|Participant Flow|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866895|NCT00394771|FG003|Participant Flow|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
10866896|NCT00394771|OG000|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866897|NCT00394771|OG001|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866898|NCT00394771|OG002|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866899|NCT00394771|OG003|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
10866900|NCT00394771|EG000|Reported Event|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866901|NCT00394771|EG001|Reported Event|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866902|NCT00394771|EG002|Reported Event|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
10866903|NCT00394771|EG003|Reported Event|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
10866904|NCT00394836|BG000|Baseline|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
10866905|NCT00394836|BG001|Baseline|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
10866906|NCT00394836|BG002|Baseline|Total|Total of all reporting groups
10866907|NCT00394836|FG000|Participant Flow|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
10866908|NCT00394836|FG001|Participant Flow|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
10866909|NCT00394836|OG000|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
10866910|NCT00394836|OG001|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
10866911|NCT00394836|EG000|Reported Event|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
10866912|NCT00394836|EG001|Reported Event|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
10866913|NCT00394836|EG002|Reported Event|Ofatumumab 500 mg: Extended Follow-up Phase|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
10866914|NCT00394836|EG003|Reported Event|Ofatumumab 1000 mg: Extended Follow-up Phase|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
10866915|NCT00394888|BG000|Baseline|Facial Hemangioma|Patients with large facial hemangioma.
10866916|NCT00394888|BG001|Baseline|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
10866917|NCT00394888|BG002|Baseline|Multiple Hemangiomas|Patients with multiple hemangiomas
10866918|NCT00394888|BG003|Baseline|Total|Total of all reporting groups
10866919|NCT00394888|FG000|Participant Flow|Facial Hemangioma|Patients with large facial hemangioma.
10866920|NCT00394888|FG001|Participant Flow|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
10866921|NCT00394888|FG002|Participant Flow|Multiple Hemangiomas|Patients with multiple hemangiomas
10866922|NCT00394888|OG000|Outcome|All Participants|entire population count for MRI/A
10866923|NCT00394888|EG000|Reported Event|Facial Hemangioma|Patients with large facial hemangioma.
10866924|NCT00394888|EG001|Reported Event|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
10866925|NCT00394888|EG002|Reported Event|Multiple Hemangiomas|Patients with multiple hemangiomas
10866926|NCT00394901|BG000|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
10866927|NCT00394901|BG001|Baseline|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
10866928|NCT00394901|BG002|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
10866929|NCT00394901|BG003|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
10866930|NCT00394901|BG004|Baseline|Total|Total of all reporting groups
10866931|NCT00394901|FG000|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
10866932|NCT00394901|FG001|Participant Flow|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
10866933|NCT00394901|FG002|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
10866934|NCT00394901|FG003|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
10866935|NCT00394901|OG000|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
10866936|NCT00394901|OG001|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
10866937|NCT00394901|OG002|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
10866938|NCT00394901|OG003|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
10866939|NCT00394901|OG000|Outcome|Placebo|Subjects who received matching placebo during a 13-week double-blind treatment phase.
10866940|NCT00394901|OG001|Outcome|Expected Pregabalin Exposure of 300 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 150 mg/day and subjects with normal CLcr (> 60 mL/min) who received pregabalin 300 mg/day.
10866941|NCT00394901|OG002|Outcome|Expected Pregabalin Exposure of 600 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 300 mg/day and subjects who received pregabalin 600 mg/day.
10866942|NCT00394901|EG000|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
10866943|NCT00394901|EG001|Reported Event|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
10866944|NCT00394901|EG002|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
10866945|NCT00394901|EG003|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
10866946|NCT00394914|BG000|Baseline|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
10866947|NCT00394914|BG001|Baseline|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
10866948|NCT00394914|BG002|Baseline|Total|Total of all reporting groups
10866949|NCT00394914|FG000|Participant Flow|All Participants (Pre-randomization)|All participants on study prior to randomization.
10866950|NCT00394914|FG001|Participant Flow|Pleconaril|Participants were randomized to receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
10866951|NCT00394914|FG002|Participant Flow|Placebo|Participants were randomized to receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
10866952|NCT00394914|OG000|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
10866953|NCT00394914|OG001|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
10866954|NCT00394914|EG000|Reported Event|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
10866955|NCT00394914|EG001|Reported Event|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
10866956|NCT00394953|BG000|Baseline|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
10866957|NCT00394953|BG001|Baseline|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
10866958|NCT00394953|BG002|Baseline|Total|Total of all reporting groups
10866959|NCT00394953|FG000|Participant Flow|MIRCERA|Participants with anemia in chronic kidney disease (CKD) who were on hemodialysis received methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) intravenously (IV) once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 microgram per month (mcg/month) for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
10866960|NCT00394953|FG001|Participant Flow|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 to Week 52.
10866961|NCT00394953|OG000|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
10866962|NCT00394953|OG001|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
10866963|NCT00394953|EG000|Reported Event|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
10866964|NCT00394953|EG001|Reported Event|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
10866965|NCT00395018|BG000|Baseline|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
10866966|NCT00395018|FG000|Participant Flow|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
10866967|NCT00395018|OG000|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
10866968|NCT00395018|EG000|Reported Event|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
10866969|NCT00395044|BG000|Baseline|Gabapentin|1200 mg/daily of Gabapentin
10866970|NCT00395044|BG001|Baseline|Placebo|1200mg/d of Placebo
10866971|NCT00395044|BG002|Baseline|Total|Total of all reporting groups
10866972|NCT00395044|FG000|Participant Flow|Gabapentin|1200 mg/daily of Gabapentin
10866973|NCT00395044|FG001|Participant Flow|Placebo|Matched Placebo
10866974|NCT00395044|OG000|Outcome|Gabapentin|1200 mg/daily of Gabapentin
10866975|NCT00395044|OG001|Outcome|Placebo|Matched Placebo
10866976|NCT00395044|EG000|Reported Event|Gabapentin|1200 mg/daily of Gabapentin
10866977|NCT00395044|EG001|Reported Event|Placebo|1200mg/d of Placebo
10866978|NCT00395057|BG000|Baseline|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
10866979|NCT00395057|BG001|Baseline|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
10866980|NCT00395057|BG002|Baseline|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
10866981|NCT00395057|BG003|Baseline|Ranibizumab 500 ug|Ranibizumab 500 ug
10866982|NCT00395057|BG004|Baseline|Total|Total of all reporting groups
10866983|NCT00395057|FG000|Participant Flow|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
10866984|NCT00395057|FG001|Participant Flow|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
10866985|NCT00395057|FG002|Participant Flow|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
10866986|NCT00395057|FG003|Participant Flow|Ranibizumab 500 ug|Ranibizumab 500 ug
10866987|NCT00395057|OG000|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
10866988|NCT00395057|OG001|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
10866989|NCT00395057|OG002|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
10866990|NCT00395057|OG003|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
10866991|NCT00395057|EG000|Reported Event|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
10866992|NCT00395057|EG001|Reported Event|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
10866993|NCT00395057|EG002|Reported Event|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
10866994|NCT00395057|EG003|Reported Event|Ranibizumab 500 ug|Ranibizumab 500 ug
10866995|NCT00395083|BG000|Baseline|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
10866996|NCT00395083|BG001|Baseline|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
10866997|NCT00395083|BG002|Baseline|Total|Total of all reporting groups
10866998|NCT00395083|FG000|Participant Flow|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
10866999|NCT00395083|FG001|Participant Flow|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
10867000|NCT00395083|OG000|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
10867001|NCT00395083|OG001|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
10867002|NCT00395083|EG000|Reported Event|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
10867003|NCT00395083|EG001|Reported Event|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
10867004|NCT00395135|BG000|Baseline|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10867005|NCT00395135|BG001|Baseline|Year 1 - Matching Placebo BID|matching placebo tablets
10867006|NCT00395135|BG002|Baseline|Total|Total of all reporting groups
10867007|NCT00395135|FG000|Participant Flow|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10867008|NCT00395135|FG001|Participant Flow|Year 1 - Matching Placebo BID|matching placebo tablets
10867009|NCT00395135|FG002|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
10867010|NCT00395135|FG003|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
10867011|NCT00395135|FG004|Participant Flow|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|Patients randomized to placebo in Year 1, completed year 1 and randomized to receive placebo in Year 2.
10867012|NCT00395135|OG000|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10867013|NCT00395135|OG001|Outcome|Matching Placebo BID|matching placebo tablets
10867014|NCT00395135|OG000|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 study with a Responder status and randomized to lorcaserin in Year 2."
10867015|NCT00395135|OG001|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 with a Responder status and randomized to placebo in Year 2."
10867016|NCT00395135|OG000|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
10867017|NCT00395135|OG001|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
10867018|NCT00395135|OG002|Outcome|Placebo (Yr 1) / Placebo (Yr 2)|Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
10867019|NCT00395135|EG000|Reported Event|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10867020|NCT00395135|EG001|Reported Event|Year 1 - Matching Placebo BID|matching placebo tablets
10867021|NCT00395135|EG002|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|lorcaserin 10 mg BID tablets
10867022|NCT00395135|EG003|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|lorcaserin 10 mg BID tablets, matching placebo tablets
10867023|NCT00395135|EG004|Reported Event|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|matching placebo tablets
10867024|NCT00395161|BG000|Baseline|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
10867025|NCT00395161|BG001|Baseline|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
10867026|NCT00395161|BG002|Baseline|Total|Total of all reporting groups
10867027|NCT00395161|FG000|Participant Flow|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
10867028|NCT00395161|FG001|Participant Flow|Enteral Whey Protein, IV Saline|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
10867029|NCT00395161|OG000|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
10977083|NCT00943592|OG000|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
10867030|NCT00395161|OG001|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
10867031|NCT00395161|OG000|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
10867032|NCT00395161|OG001|Outcome|Enteral Whey Protein, IV Saline|
10867033|NCT00395161|EG000|Reported Event|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
10867034|NCT00395161|EG001|Reported Event|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
10867035|NCT00395226|BG000|Baseline|Placebo (Lactose)|
10867036|NCT00395226|BG001|Baseline|Zinc Sulfate|
10867037|NCT00395226|BG002|Baseline|Total|Total of all reporting groups
10867038|NCT00395226|FG000|Participant Flow|Placebo (Lactose)|
10867039|NCT00395226|FG001|Participant Flow|Zinc Sulfate|
10867040|NCT00395226|OG000|Outcome|Placebo (Lactose)|
10867041|NCT00395226|OG001|Outcome|Zinc Sulfate|
10867042|NCT00395226|EG000|Reported Event|Placebo (Lactose)|
10867043|NCT00395226|EG001|Reported Event|Zinc Sulfate|
10867044|NCT00395291|BG000|Baseline|Entire Study Population|Includes groups randomized to placebo first and MK-0677 first.
10867045|NCT00395291|FG000|Participant Flow|MK-0677 First, Then Placebo|Subjects took 25mg of MK-0677 for at least 30 Days.
10867046|NCT00395291|FG001|Participant Flow|Placebo First, Then MK-0677|Subjects took Placebo for at least 30 days.
10867047|NCT00395291|OG000|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
10867048|NCT00395291|OG001|Outcome|Placebo|Subjects took Placebo for at least 30 days.
10867049|NCT00395291|EG000|Reported Event|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
10867050|NCT00395291|EG001|Reported Event|Placebo|Subjects took Placebo for at least 30 days.
10867051|NCT00395304|BG000|Baseline|All Participants|All participants randomized to the six crossover sequences
10867052|NCT00395304|FG000|Participant Flow|2xICS, 1xICS + LABA, 1xICS + LTRA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
10867053|NCT00395304|FG001|Participant Flow|2xICS, 1xICS + LTRA, 1xICS + LABA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
10867054|NCT00395304|FG002|Participant Flow|1xICS +LABA, 2xICS, 1xICS + LTRA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
10977084|NCT00943592|EG000|Reported Event|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
10867055|NCT00395304|FG003|Participant Flow|1xICS + LABA, 1xICS + LTRA, 2xICS|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
10867056|NCT00395304|FG004|Participant Flow|1xICS + LTRA, 2xICS, 1xICS + LABA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
10867057|NCT00395304|FG005|Participant Flow|1xICS + LTRA, 1xICS + LABA, 2xICS|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
10867058|NCT00395304|OG000|Outcome|All Participants|All participants randomized to the six crossover sequences
10867059|NCT00395304|OG000|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
10867060|NCT00395304|OG001|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
10867061|NCT00395304|OG002|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
10867062|NCT00395304|EG000|Reported Event|All Participants|All participants randomized to the six crossover sequences
10867063|NCT00395343|BG000|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
10867064|NCT00395343|BG001|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
10867065|NCT00395343|BG002|Baseline|Total|Total of all reporting groups
10867066|NCT00395343|FG000|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
10867067|NCT00395343|FG001|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
10867068|NCT00395343|OG000|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
10867069|NCT00395343|OG001|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
10867070|NCT00395343|EG000|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
10867071|NCT00395343|EG001|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
10867072|NCT00395447|BG000|Baseline|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
10867073|NCT00395447|BG001|Baseline|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
11336539|NCT03567980|FG000|Participant Flow|Topical Crisaborole 2%|Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
10867074|NCT00395447|BG002|Baseline|Total|Total of all reporting groups
10867075|NCT00395447|FG000|Participant Flow|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
10867076|NCT00395447|FG001|Participant Flow|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
10867077|NCT00395447|OG000|Outcome|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
10977085|NCT00943631|BG000|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
11336540|NCT03567980|OG000|Outcome|Topical Crisaborole 2%|Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
10867078|NCT00395447|OG001|Outcome|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
10867079|NCT00395447|EG000|Reported Event|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
10867080|NCT00395447|EG001|Reported Event|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
10867081|NCT00395460|BG000|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
10867082|NCT00395460|BG001|Baseline|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
10867083|NCT00395460|BG002|Baseline|Total|Total of all reporting groups
10867084|NCT00395460|FG000|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
10867085|NCT00395460|FG001|Participant Flow|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
10867086|NCT00395460|OG000|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
10867087|NCT00395460|OG001|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
10867088|NCT00395460|EG000|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
10867089|NCT00395460|EG001|Reported Event|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
10867090|NCT00395486|BG000|Baseline|Rosuvastatin|10mg
10867091|NCT00395486|BG001|Baseline|Atorvastatin|10mg
10867092|NCT00395486|BG002|Baseline|Total|Total of all reporting groups
10867093|NCT00395486|FG000|Participant Flow|Rosuvastatin|10mg
10867094|NCT00395486|FG001|Participant Flow|Atorvastatin|10mg
10867095|NCT00395486|OG000|Outcome|Rosuvastatin|10mg
10867096|NCT00395486|OG001|Outcome|Atorvastatin|10mg
10867097|NCT00395486|EG000|Reported Event|Rosuvastatin|10mg
10867098|NCT00395486|EG001|Reported Event|Atorvastatin|10mg
10867099|NCT00395512|BG000|Baseline|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10867100|NCT00395512|BG001|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
10867101|NCT00395512|BG002|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10867102|NCT00395512|BG003|Baseline|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10867103|NCT00395512|BG004|Baseline|Total|Total of all reporting groups
10867104|NCT00395512|FG000|Participant Flow|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10867105|NCT00395512|FG001|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
10867106|NCT00395512|FG002|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10867107|NCT00395512|FG003|Participant Flow|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10867108|NCT00395512|OG000|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10867109|NCT00395512|OG001|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
10867110|NCT00395512|OG002|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10867111|NCT00395512|OG003|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10867112|NCT00395512|EG000|Reported Event|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
10867113|NCT00395512|EG001|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
10867114|NCT00395512|EG002|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10867115|NCT00395512|EG003|Reported Event|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
10867116|NCT00395538|BG000|Baseline|Cohort 1 (HPTH on Old Study) and Received HPTH on New Study|Cohort 1 was treated with HPTH therapy on original protocol. Cohort 1 participants who consented to the new protocol and were treated with HPTH on the new protocol were followed for safety outcomes only. The Safety population of Cohort 1 consisted of 7 participants.
10867117|NCT00395538|BG001|Baseline|Cohort 2 (CC on Old Study) and Treated With HPTH on New Study|Cohort 2 consists of participants previously treated with conventional care (CC) throughout the original protocol. Cohort 2 participants who received at least one dose of HPTH on the new protocol were included in safety population. Cohort 2 safety population includes 5 participants.
10867118|NCT00395538|BG002|Baseline|Cohort 3 (Newly Enrolled) and Treated With HPTH on New Study|Cohort 3 consists of new participants (i.e. not previously enrolled) that consented to the revised protocol. The Cohort 3 safety population includes 19 subjects who received any HPTH on the new study.
10867119|NCT00395538|BG003|Baseline|Total|Total of all reporting groups
10867120|NCT00395538|FG000|Participant Flow|Cohort 1: Received HPTH on Original Protocol|Treated with HPTH therapy on original protocol
10867121|NCT00395538|FG001|Participant Flow|Cohort 2: Received Conventional Care on Original Protocol|Treated with conventional care (CC) throughout original protocol
10867122|NCT00395538|FG002|Participant Flow|Cohort 3: Newly Enrolled No Prior Participation|New participants in revised protocol
10867123|NCT00395538|OG000|Outcome|Cohorts 2 (CC on Old Study) and 3 (Newly Enrolled) Combined|Cohort 2 consists of participants previously treated with conventional care (CC) throughout the original protocol. Cohort 3 consisted of all new participants. Efficacy outcomes were only analyzed for Cohorts 2 and 3. (Cohort 1 consisted of previously enrolled participants who were on HPTH therapy on the original protocol and continued on HPTH on the new study as a separate group. These participants were not randomized to a bone biopsy year, nor did they have additional biopsies performed. Cohort 1 participants were followed for safety outcomes only. )
10867124|NCT00395538|OG000|Outcome|Cohorts 2 (CC on Old Study) and 3 (Newly Enrolled) Combined|Cohort 2 consists of participants previously treated with conventional care (CC) throughout the original protocol. Cohort 3 consisted of all new participants. Efficacy outcomes were only analyzed for Cohorts 2 and 3. (Cohort 1 consisted of previously enrolled participants who were on HPTH therapy on the original protocol and continued on HPTH on the new study as a separate group. These participants were not randomized to a bone biopsy year, nor did they have additional biopsies performed. Cohort 1 participants were followed for safety outcomes only.)
10867125|NCT00395538|OG000|Outcome|Cohorts 2 and 3 Combined|Cohort 1 consisted of previously enrolled participants who were on HPTH therapy, were re-consented, and allowed to continue on the current study as a separate group. These participants were not randomized to a bone biopsy year, nor did they have additional biopsies performed. Cohort 1 participants were followed for safety outcomes only. Cohort 2 were previously enrolled participants on conventional care, were re-consented, re-enrolled, and randomized to a biopsy year. Cohort 3 consisted of all new participants consent, enrolled and randomized to a biopsy year. Efficacy outcomes were only analyzed for Cohorts 2 and 3 combined.
10867126|NCT00395538|OG000|Outcome|Cohorts 2 (CC on Old Study) and 3 (Newly Enrolled) Combined|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. The randomization to a biopsy year provided the opportunity to compare the effects of PTH across-time, in a cross-sectional manner. However, because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group.
10867127|NCT00395538|OG000|Outcome|Cohorts 2 (CC on Old Study) and 3 (Newly Enrolled) Combined|Cohort 1 consisted of previously enrolled participants who were on HPTH therapy, were re-consented, and allowed to continue on the current study as a separate group. These participants were not randomized to a bone biopsy year, nor did they have additional biopsies performed. Cohort 1 participants were followed for safety outcomes only. Cohort 2 were previously enrolled participants on conventional care, were re-consented, re-enrolled, and randomized to a biopsy year. Cohort 3 consisted of all new participants consent, enrolled and randomized to a biopsy year. Efficacy outcomes were only analyzed for Cohorts 2 and 3 combined.
10867128|NCT00395538|EG000|Reported Event|All Cohorts, Treated With HPTH on the New Study|Participants from Cohorts 1, 2, and 3, who were treated with HPTH on the new study.
10867129|NCT00395629|BG000|Baseline|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867130|NCT00395629|BG001|Baseline|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867131|NCT00395629|BG002|Baseline|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867132|NCT00395629|BG003|Baseline|Total|Total of all reporting groups
10867133|NCT00395629|FG000|Participant Flow|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867134|NCT00395629|FG001|Participant Flow|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867135|NCT00395629|FG002|Participant Flow|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867136|NCT00395629|OG000|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867137|NCT00395629|OG001|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867138|NCT00395629|OG002|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867139|NCT00395629|EG000|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867140|NCT00395629|EG001|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867141|NCT00395629|EG002|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867142|NCT00395629|EG003|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867143|NCT00395629|EG004|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867144|NCT00395629|EG005|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
10867145|NCT00395642|BG000|Baseline|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
10867146|NCT00395642|FG000|Participant Flow|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
10867147|NCT00395642|OG000|Outcome|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
10867148|NCT00395642|EG000|Reported Event|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
10867149|NCT00395694|BG000|Baseline|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
10867150|NCT00395694|BG001|Baseline|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
10867151|NCT00395694|BG002|Baseline|Total|Total of all reporting groups
10867152|NCT00395694|FG000|Participant Flow|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
10867153|NCT00395694|FG001|Participant Flow|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
10867154|NCT00395694|OG000|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
10867155|NCT00395694|OG001|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
10879159|NCT00455741|OG000|Outcome|Young Postmenopausal Women|"Graded estradiol infusion to young postmenopausal women. Graded progesterone infusion to young postmenopausal women.~Estradiol infusion: Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10867156|NCT00395694|OG002|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
10867157|NCT00395694|OG000|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
10867158|NCT00395694|EG000|Reported Event|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
10867159|NCT00395694|EG001|Reported Event|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
10867160|NCT00395694|EG002|Reported Event|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
10867161|NCT00395733|BG000|Baseline|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
10867162|NCT00395733|BG001|Baseline|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
10867163|NCT00395733|BG002|Baseline|Total|Total of all reporting groups
10867164|NCT00395733|FG000|Participant Flow|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Gadobutrol 0.2 - 0.3 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
10977086|NCT00943631|BG001|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977087|NCT00943631|BG002|Baseline|Total|Total of all reporting groups
11336541|NCT03567980|EG000|Reported Event|Topical Crisaborole 2%|Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
10867165|NCT00395733|FG001|Participant Flow|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadobutrol 0.2 - 0.3 mmol/kg BW (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
10867166|NCT00395733|OG000|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
10867167|NCT00395733|OG001|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
10867168|NCT00395733|EG000|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
10867169|NCT00395733|EG001|Reported Event|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
10867170|NCT00395746|BG000|Baseline|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867171|NCT00395746|BG001|Baseline|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867172|NCT00395746|BG002|Baseline|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867173|NCT00395746|BG003|Baseline|Total|Total of all reporting groups
10867174|NCT00395746|FG000|Participant Flow|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867175|NCT00395746|FG001|Participant Flow|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867176|NCT00395746|FG002|Participant Flow|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867177|NCT00395746|OG000|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867178|NCT00395746|OG001|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867179|NCT00395746|OG002|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867180|NCT00395746|EG000|Reported Event|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
11336542|NCT03568500|BG000|Baseline|Aripiprazole|Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks.
10867181|NCT00395746|EG001|Reported Event|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867182|NCT00395746|EG002|Reported Event|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
10867183|NCT00395850|BG000|Baseline|Placebo|microcrystalline cellulose
10867184|NCT00395850|BG001|Baseline|Disulfiram 250|disulfiram at 250 mg/day
10867185|NCT00395850|BG002|Baseline|Disulfiram 375|Disulfiram at 375 mg/day
10867186|NCT00395850|BG003|Baseline|Disulfiram 500|Disulfiram at 500 mg/day
10867187|NCT00395850|BG004|Baseline|Total|Total of all reporting groups
10867188|NCT00395850|FG000|Participant Flow|Placebo|microcrystalline cellulose
10867189|NCT00395850|FG001|Participant Flow|Disulfiram 250|disulfiram at 250 mg/day
10867190|NCT00395850|FG002|Participant Flow|Disulfiram 375|Disulfiram at 375 mg/day
10867191|NCT00395850|FG003|Participant Flow|Disulfiram 500|Disulfiram at 500 mg/day
10867192|NCT00395850|OG000|Outcome|Placebo|microcrystalline cellulose
10867193|NCT00395850|OG001|Outcome|Disulfiram 250|disulfiram at 250 mg/day
10867194|NCT00395850|OG002|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
10867195|NCT00395850|OG003|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
10867196|NCT00395850|EG000|Reported Event|Placebo|microcrystalline cellulose
10867197|NCT00395850|EG001|Reported Event|Disulfiram 250|disulfiram at 250 mg/day
10867198|NCT00395850|EG002|Reported Event|Disulfiram 375|Disulfiram at 375 mg/day
10867199|NCT00395850|EG003|Reported Event|Disulfiram 500|Disulfiram at 500 mg/day
10867200|NCT00395863|BG000|Baseline|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
10867201|NCT00395863|BG001|Baseline|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
10867202|NCT00395863|BG002|Baseline|Total|Total of all reporting groups
10867203|NCT00395863|FG000|Participant Flow|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
10867204|NCT00395863|FG001|Participant Flow|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
10867205|NCT00395863|OG000|Outcome|Reader 1|Reader 1 Assessment
10867206|NCT00395863|OG001|Outcome|Reader 2|Reader 2 Assessment
10867207|NCT00395863|OG002|Outcome|Reader 3|Reader 3 Assessment
10867208|NCT00395863|OG000|Outcome|MultiHance|0.1 mmol/kg injection
10867209|NCT00395863|OG001|Outcome|Magnevist|0.1 mmol/kg injection
11336543|NCT03568500|BG001|Baseline|Olanzapine|Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
10867210|NCT00395863|EG000|Reported Event|MultiHance|Adverse events experienced by patients occurred relative to the administration of MultiHance.
10867211|NCT00395863|EG001|Reported Event|Magnevist|Adverse events experienced by patients occurred relative to the administration of Magnevist.
10867212|NCT00395876|BG000|Baseline|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
10867213|NCT00395876|BG001|Baseline|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
10867214|NCT00395876|BG002|Baseline|Total|Total of all reporting groups
10867215|NCT00395876|FG000|Participant Flow|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
10867216|NCT00395876|FG001|Participant Flow|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
10867217|NCT00395876|OG000|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
10867218|NCT00395876|OG001|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
10867219|NCT00395876|EG000|Reported Event|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
10867220|NCT00395876|EG001|Reported Event|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
10867221|NCT00395967|BG000|Baseline|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
10867222|NCT00395967|FG000|Participant Flow|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
10977088|NCT00943631|FG000|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10867223|NCT00395967|OG000|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
10867224|NCT00395967|EG000|Reported Event|All Patients|All patients (3 NHL, 1 MM, and 1 HD).
10867225|NCT00395993|BG000|Baseline|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
10867226|NCT00395993|BG001|Baseline|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
10867227|NCT00395993|BG002|Baseline|Total|Total of all reporting groups
10867228|NCT00395993|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
10867229|NCT00395993|FG001|Participant Flow|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
10867230|NCT00395993|OG000|Outcome|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
10867231|NCT00395993|OG001|Outcome|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
10867232|NCT00395993|EG000|Reported Event|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
10867233|NCT00395993|EG001|Reported Event|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
10867234|NCT00396006|BG000|Baseline|Participants Treated With ARALAST Fr. IV-1|
10867235|NCT00396006|FG000|Participant Flow|Participants Treated With ARALAST Fraction IV-1 (Fr. IV-1)|Weekly infusions of ARALAST Fr. IV-1 were administered to participants at a dosage of 60 mg/kg
10867236|NCT00396006|OG000|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
10867237|NCT00396006|OG000|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
10867238|NCT00396006|EG000|Reported Event|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
10867239|NCT00396019|BG000|Baseline|Stratum 1 No Symptom With or Withour Tumor Growth|Peg-intron given every week
10867240|NCT00396019|BG001|Baseline|Stratum 2 Symptoms no Tumor Growth|Peg-intron given every week
10867241|NCT00396019|BG002|Baseline|Stratum 3 Tumor Growth With or Without Symptoms|Peg-intron given every week
10867242|NCT00396019|BG003|Baseline|Total|Total of all reporting groups
10867243|NCT00396019|FG000|Participant Flow|Stratum 1 No Symptom With or Withour Tumor Growth|Peg-intron given every week
10867244|NCT00396019|FG001|Participant Flow|Stratum 2 Symptoms no Tumor Growth|Peg-intron given every week
10867245|NCT00396019|FG002|Participant Flow|Stratum 3 Tumor Growth With or Without Symptoms|Peg-intron given every week
10867246|NCT00396019|OG000|Outcome|Stratum 1 No Symptom With or Withour Tumor Growth|Peg-intron given every week
10867247|NCT00396019|OG001|Outcome|Stratum 2 Symptoms no Tumor Growth|Peg-intron given every week
10867248|NCT00396019|OG000|Outcome|Stratum 2 Symptoms on Tumor Growth|Peg-intron given every week
10867249|NCT00396019|OG000|Outcome|Stratum 3: Tumor Growth With or Without Symptoms|Peg-intron given every week
10867250|NCT00396019|EG000|Reported Event|Stratum 1 No Symptom With or Withour Tumor Growth|Peg-intron given every week
10867251|NCT00396019|EG001|Reported Event|Stratum 2 Symptoms no Tumor Growth|Peg-intron given every week
10867252|NCT00396019|EG002|Reported Event|Stratum 3 Tumor Growth With or Without Symptoms|Peg-intron given every week
10867253|NCT00396032|BG000|Baseline|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
10867254|NCT00396032|BG001|Baseline|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
10867255|NCT00396032|BG002|Baseline|Total|Total of all reporting groups
10867256|NCT00396032|FG000|Participant Flow|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
10867257|NCT00396032|FG001|Participant Flow|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
10867258|NCT00396032|OG000|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
10867259|NCT00396032|OG001|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
10867260|NCT00396032|EG000|Reported Event|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
10867261|NCT00396032|EG001|Reported Event|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
10867262|NCT00396084|BG000|Baseline|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
10867263|NCT00396084|BG001|Baseline|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
10867264|NCT00396084|BG002|Baseline|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
10867265|NCT00396084|BG003|Baseline|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
10867266|NCT00396084|BG004|Baseline|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
10867267|NCT00396084|BG005|Baseline|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
10867268|NCT00396084|BG006|Baseline|Total|Total of all reporting groups
10867269|NCT00396084|FG000|Participant Flow|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
10867270|NCT00396084|FG001|Participant Flow|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
10867271|NCT00396084|FG002|Participant Flow|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
10867272|NCT00396084|FG003|Participant Flow|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
10867273|NCT00396084|FG004|Participant Flow|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
10867274|NCT00396084|FG005|Participant Flow|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
10867275|NCT00396084|OG000|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
10867276|NCT00396084|OG001|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
10867277|NCT00396084|OG002|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
10867278|NCT00396084|OG003|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
10867279|NCT00396084|OG000|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
10867280|NCT00396084|OG001|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
10867281|NCT00396084|OG002|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
10867282|NCT00396084|OG001|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
10867283|NCT00396084|OG000|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
10867284|NCT00396084|OG001|Outcome|Linezolid 600 mg/Once Daily|Linezolid 600 mg/day x 7 days
10867285|NCT00396084|EG000|Reported Event|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
10867286|NCT00396084|EG001|Reported Event|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
10867287|NCT00396084|EG002|Reported Event|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
10867288|NCT00396084|EG003|Reported Event|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
10867289|NCT00396084|EG004|Reported Event|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
10867290|NCT00396084|EG005|Reported Event|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
10867291|NCT00396097|BG000|Baseline|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
10867292|NCT00396097|BG001|Baseline|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
10867293|NCT00396097|BG002|Baseline|Total|Total of all reporting groups
10867294|NCT00396097|FG000|Participant Flow|Standard Dose Arm|The participants received subcutaneous genotropin, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
10867295|NCT00396097|FG001|Participant Flow|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
10867296|NCT00396097|OG000|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
10867297|NCT00396097|OG001|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
10867298|NCT00396097|OG001|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
10867299|NCT00396097|OG002|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
10867300|NCT00396097|OG003|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
10867301|NCT00396097|OG003|Outcome|Individualized Dose Arm 0.24/mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
10867302|NCT00396097|EG000|Reported Event|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
10867303|NCT00396097|EG001|Reported Event|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
10867304|NCT00396136|BG000|Baseline|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
10867305|NCT00396136|FG000|Participant Flow|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
10867306|NCT00396136|OG000|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
10867307|NCT00396136|EG000|Reported Event|Group 1|
10867308|NCT00396162|BG000|Baseline|Probiotic|"drug~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
10867309|NCT00396162|BG001|Baseline|Placebo Pill|"Placebo pills on same schedule as active intervention.~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
10867310|NCT00396162|BG002|Baseline|Total|Total of all reporting groups
10867311|NCT00396162|FG000|Participant Flow|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
10867312|NCT00396162|FG001|Participant Flow|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
10867313|NCT00396162|OG000|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
10867314|NCT00396162|OG001|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
10867315|NCT00396162|OG000|Outcome|Placebo Pill|"Placebo pills on same schedule as active intervention.~Placebo: Placebo pill"
10867316|NCT00396162|OG001|Outcome|Probiotic|"L. rhamnosus R0011 strain~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
10867317|NCT00396162|OG000|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
10867318|NCT00396162|OG001|Outcome|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
10867319|NCT00396162|EG000|Reported Event|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
10867320|NCT00396162|EG001|Reported Event|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
10867321|NCT00396201|BG000|Baseline|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
10867322|NCT00396201|FG000|Participant Flow|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with granulocyte-colony stimulating factor (G-CSF) [10 µg/kg each day (QD)] and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
10867323|NCT00396201|OG000|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
10867324|NCT00396201|OG000|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
10867325|NCT00396201|EG000|Reported Event|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
10867326|NCT00396253|BG000|Baseline|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
10867327|NCT00396253|FG000|Participant Flow|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
10867328|NCT00396253|OG000|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
10867329|NCT00396253|EG000|Reported Event|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
10867330|NCT00396266|BG000|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867331|NCT00396266|BG001|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867332|NCT00396266|BG002|Baseline|Total|Total of all reporting groups
10977089|NCT00943631|FG001|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977090|NCT00943631|OG000|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10867333|NCT00396266|FG000|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867334|NCT00396266|FG001|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867335|NCT00396266|OG000|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867336|NCT00396266|OG001|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867337|NCT00396266|OG002|Outcome|Total|All patients.
10867338|NCT00396266|OG000|Outcome|Non-hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867339|NCT00396266|OG000|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
10867340|NCT00396266|OG000|Outcome|PD Subgroup|Subgroup of 4 patients (3 MM and 1 NHL) for which a pharmacodynamic (PD) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
10867341|NCT00396266|EG000|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867342|NCT00396266|EG001|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10867343|NCT00396279|BG000|Baseline|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
10867344|NCT00396279|FG000|Participant Flow|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
10867345|NCT00396279|OG000|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
10867346|NCT00396279|EG000|Reported Event|Denosumab 120 mg Q4W|Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.
10867347|NCT00396292|BG000|Baseline|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
10867348|NCT00396292|BG001|Baseline|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
10867349|NCT00396292|BG002|Baseline|Total|Total of all reporting groups
10867350|NCT00396292|FG000|Participant Flow|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
10867351|NCT00396292|FG001|Participant Flow|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
10867352|NCT00396292|OG000|Outcome|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
10867353|NCT00396292|OG001|Outcome|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
10867354|NCT00396292|EG000|Reported Event|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
10867355|NCT00396292|EG001|Reported Event|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
10867356|NCT00396318|BG000|Baseline|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
10867357|NCT00396318|FG000|Participant Flow|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
10867358|NCT00396318|OG000|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
10867359|NCT00396318|EG000|Reported Event|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
10867360|NCT00396331|BG000|Baseline|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867361|NCT00396331|BG001|Baseline|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867362|NCT00396331|BG002|Baseline|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867363|NCT00396331|BG003|Baseline|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867364|NCT00396331|BG004|Baseline|Total|Total of all reporting groups
10867365|NCT00396331|FG000|Participant Flow|G-CSF Plus Plerixafor|Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867366|NCT00396331|OG000|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10977091|NCT00943631|OG001|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10867367|NCT00396331|OG001|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867368|NCT00396331|OG002|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867369|NCT00396331|OG003|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867370|NCT00396331|OG004|Outcome|All Patients|
10867371|NCT00396331|OG000|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867372|NCT00396331|EG000|Reported Event|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867373|NCT00396331|EG001|Reported Event|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867374|NCT00396331|EG002|Reported Event|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867375|NCT00396331|EG003|Reported Event|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
10867376|NCT00396383|BG000|Baseline|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
10867377|NCT00396383|FG000|Participant Flow|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
10867378|NCT00396383|OG000|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
10867379|NCT00396383|EG000|Reported Event|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
10867380|NCT00396409|BG000|Baseline|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
10867381|NCT00396409|BG001|Baseline|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
10867382|NCT00396409|BG002|Baseline|Total|Total of all reporting groups
10867383|NCT00396409|FG000|Participant Flow|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
10867384|NCT00396409|FG001|Participant Flow|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
10867385|NCT00396409|OG000|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
10867386|NCT00396409|OG001|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
10867387|NCT00396409|EG000|Reported Event|Depigoid + Omalizumab 2007|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
10867388|NCT00396409|EG001|Reported Event|Depigoid + Omalizumab 2008|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
10867389|NCT00396409|EG002|Reported Event|Depigoid + Placebo 2007|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
10867390|NCT00396409|EG003|Reported Event|Depigoid + Placebo 2008|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
10867391|NCT00396565|BG000|Baseline|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
10867392|NCT00396565|BG001|Baseline|Placebo|Two placebo tablets once daily for 6 weeks
10867393|NCT00396565|BG002|Baseline|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
10867394|NCT00396565|BG003|Baseline|Total|Total of all reporting groups
10867395|NCT00396565|FG000|Participant Flow|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
10867396|NCT00396565|FG001|Participant Flow|Placebo|Two placebo tablets once daily for 6 weeks
10867397|NCT00396565|FG002|Participant Flow|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
10867398|NCT00396565|OG000|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
10867399|NCT00396565|OG001|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
10867400|NCT00396565|OG002|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
10867401|NCT00396565|EG000|Reported Event|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
10867402|NCT00396565|EG001|Reported Event|Placebo|Two placebo tablets once daily for 6 weeks
10867403|NCT00396565|EG002|Reported Event|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
10977092|NCT00943631|EG000|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10977093|NCT00943631|EG001|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
10867404|NCT00396591|BG000|Baseline|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
10867405|NCT00396591|FG000|Participant Flow|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
10867406|NCT00396591|OG000|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
10867407|NCT00396591|EG000|Reported Event|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
10867408|NCT00396630|BG000|Baseline|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867409|NCT00396630|BG001|Baseline|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867410|NCT00396630|BG002|Baseline|Total|Total of all reporting groups
10867411|NCT00396630|FG000|Participant Flow|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867412|NCT00396630|FG001|Participant Flow|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867413|NCT00396630|OG000|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867414|NCT00396630|OG000|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867415|NCT00396630|OG001|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867416|NCT00396630|EG000|Reported Event|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867417|NCT00396630|EG001|Reported Event|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
10867418|NCT00396656|BG000|Baseline|Entire Study Population|Includes patients that received valsartan followed by atenolol + hydrochlorothiazide and patients that received atenolol + hydrochlorothiazide followed by valsartan.
10867419|NCT00396656|FG000|Participant Flow|Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)|"After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.~After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning."
10867420|NCT00396656|FG001|Participant Flow|Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan|"After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.~After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning"
10867421|NCT00396656|OG000|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
10867422|NCT00396656|OG001|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
10867423|NCT00396656|EG000|Reported Event|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
10867424|NCT00396656|EG001|Reported Event|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
10867425|NCT00396812|BG000|Baseline|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
10867426|NCT00396812|FG000|Participant Flow|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
10867427|NCT00396812|OG000|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
10867428|NCT00396812|EG000|Reported Event|Rituximab|Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2. Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid.
11336544|NCT03568500|BG002|Baseline|Quetiapine|Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
11336545|NCT03568500|BG003|Baseline|Total|Total of all reporting groups
10867429|NCT00396877|BG000|Baseline|Placebo|
10867430|NCT00396877|BG001|Baseline|Clopidogrel 0.2 mg/kg/Day|
10867431|NCT00396877|BG002|Baseline|Total|Total of all reporting groups
10867432|NCT00396877|FG000|Participant Flow|Placebo|Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
10867433|NCT00396877|FG001|Participant Flow|Clopidogrel 0.2 mg/kg/Day|"Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.~Route: oral or enteric~Frequency: once daily~Dose: daily dose adjusted for weight"
10867434|NCT00396877|OG000|Outcome|Placebo|
10867435|NCT00396877|OG001|Outcome|Clopidogrel 0.2 mg/kg/Day|
10867436|NCT00396877|EG000|Reported Event|Placebo|
10867437|NCT00396877|EG001|Reported Event|Clopidogrel 0.2mg/kg/Day|
10867438|NCT00396981|BG000|Baseline|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion~Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
10867439|NCT00396981|BG001|Baseline|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion~GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
10867440|NCT00396981|BG002|Baseline|Total|Total of all reporting groups
10867441|NCT00396981|FG000|Participant Flow|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion~Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
10867442|NCT00396981|FG001|Participant Flow|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion~GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
10867443|NCT00396981|OG000|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
10867444|NCT00396981|OG001|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
10867445|NCT00396981|EG000|Reported Event|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
10867446|NCT00396981|EG001|Reported Event|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
10867447|NCT00397020|BG000|Baseline|1 Divalproex ER|Divalproex ER
10867448|NCT00397020|BG001|Baseline|2 Quetiapine Fumarate|quetiapine fumarate
10867449|NCT00397020|BG002|Baseline|Total|Total of all reporting groups
10867450|NCT00397020|FG000|Participant Flow|1 Divalproex ER|Divalproex ER
10867451|NCT00397020|FG001|Participant Flow|2 Quetiapine Fumarate|quetiapine fumarate
10867452|NCT00397020|OG000|Outcome|1 Divalproex ER|Divalproex ER
10867453|NCT00397020|OG001|Outcome|2 Quetiapine Fumarate|quetiapine fumarate
10867454|NCT00397020|EG000|Reported Event|1 Divalproex ER|Divalproex ER
10867455|NCT00397020|EG001|Reported Event|2 Quetiapine Fumarate|quetiapine fumarate
10867456|NCT00397033|BG000|Baseline|Placebo|
10867457|NCT00397033|BG001|Baseline|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
10867458|NCT00397033|BG002|Baseline|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
10867459|NCT00397033|BG003|Baseline|Total|Total of all reporting groups
10867460|NCT00397033|FG000|Participant Flow|Placebo|
10867461|NCT00397033|FG001|Participant Flow|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
10867462|NCT00397033|FG002|Participant Flow|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
10867463|NCT00397033|OG000|Outcome|Placebo|
10867464|NCT00397033|OG001|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
10867465|NCT00397033|OG002|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
10867466|NCT00397033|EG000|Reported Event|Placebo|
10867467|NCT00397033|EG001|Reported Event|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
10867468|NCT00397033|EG002|Reported Event|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
10867469|NCT00397046|BG000|Baseline|Neratinib 80 mg|Neratinib 80 mg qd
10867470|NCT00397046|BG001|Baseline|Neratinib 160 mg|Neratinib 160 mg qd
10867471|NCT00397046|BG002|Baseline|Neratinib 240 mg|Neratinib 240 mg qd
10867472|NCT00397046|BG003|Baseline|Neratinib 320 mg|Neratinib 320 mg qd
10867473|NCT00397046|BG004|Baseline|Total|Total of all reporting groups
10867474|NCT00397046|FG000|Participant Flow|Neratinib 80 mg|Neratinib 80 mg qd
10867475|NCT00397046|FG001|Participant Flow|Neratinib 160 mg|Neratinib 160 mg qd
10867476|NCT00397046|FG002|Participant Flow|Neratinib 240 mg|Neratinib 240 mg qd
10867477|NCT00397046|FG003|Participant Flow|Neratinib 320 mg|Neratinib 320 mg qd
10867478|NCT00397046|OG000|Outcome|Neratinib 80 mg|Neratinib 80 mg qd
10867479|NCT00397046|OG001|Outcome|Neratinib 160 mg|Neratinib 160 mg qd
10867480|NCT00397046|OG002|Outcome|Neratinib 240 mg|Neratinib 240 mg qd
10867481|NCT00397046|OG003|Outcome|Neratinib 320 mg|Neratinib 320 mg qd
10867482|NCT00397046|OG000|Outcome|Neratinib 240 mg|Neratinib 240 mg qd
10867483|NCT00397046|EG000|Reported Event|Neratinib 80 mg|Neratinib 80 mg qd
10867484|NCT00397046|EG001|Reported Event|Neratinib 160 mg|Neratinib 160 mg qd
10867485|NCT00397046|EG002|Reported Event|Neratinib 240 mg|Neratinib 240 mg qd
10867486|NCT00397046|EG003|Reported Event|Neratinib 320 mg|Neratinib 320 mg qd
10867487|NCT00397150|BG000|Baseline|Intervention|Peer-counselling for exclusive breastfeeding
10867488|NCT00397150|BG001|Baseline|No Intervention|Standard of care
10867489|NCT00397150|BG002|Baseline|Total|Total of all reporting groups
10867490|NCT00397150|FG000|Participant Flow|Intervention|Peer-counselling for exclusive breastfeeding
10867491|NCT00397150|FG001|Participant Flow|No Intervention|Standard of care
10867492|NCT00397150|OG000|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
10867493|NCT00397150|OG001|Outcome|No Intervention|Standard of care
10867494|NCT00397150|EG000|Reported Event|Peer Counselling for Exclusive Breastfeeding|
10867495|NCT00397150|EG001|Reported Event|Standard of Care|
10867496|NCT00397189|BG000|Baseline|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
10867497|NCT00397189|BG001|Baseline|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
10867498|NCT00397189|BG002|Baseline|Total|Total of all reporting groups
10867499|NCT00397189|FG000|Participant Flow|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
10867500|NCT00397189|FG001|Participant Flow|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
10867501|NCT00397189|OG000|Outcome|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
10867502|NCT00397189|OG001|Outcome|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
10867503|NCT00397189|OG000|Outcome|Circadin|Circadin: Prolonged release melatonin 2 mg
10867504|NCT00397189|OG001|Outcome|Placebo|placebo circadin: placebo circadin tablets
10867505|NCT00397189|EG000|Reported Event|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
10867506|NCT00397189|EG001|Reported Event|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
10867507|NCT00397215|BG000|Baseline|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
10867508|NCT00397215|BG001|Baseline|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
10867509|NCT00397215|BG002|Baseline|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867510|NCT00397215|BG003|Baseline|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867511|NCT00397215|BG004|Baseline|Total|Total of all reporting groups
10867512|NCT00397215|FG000|Participant Flow|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
10867513|NCT00397215|FG001|Participant Flow|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
10867514|NCT00397215|FG002|Participant Flow|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867515|NCT00397215|FG003|Participant Flow|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867516|NCT00397215|OG000|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
11336546|NCT03568500|FG000|Participant Flow|Aripiprazole|Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks.
10846094|NCT00272987|BG002|Baseline|Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
10846095|NCT00272987|BG003|Baseline|Total|Total of all reporting groups
10846096|NCT00272987|FG000|Participant Flow|Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
10846097|NCT00272987|FG001|Participant Flow|Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
10846098|NCT00272987|FG002|Participant Flow|Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
10846099|NCT00272987|OG000|Outcome|Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
10846100|NCT00272987|OG001|Outcome|Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
10846101|NCT00272987|OG002|Outcome|Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
10846102|NCT00272987|EG000|Reported Event|Cohort 1: Paclitaxel 80mg/Trastuzumab 4 mg/Lapatinib 1000mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
10846103|NCT00272987|EG001|Reported Event|Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
10846104|NCT00272987|EG002|Reported Event|Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
10846105|NCT00273052|BG000|Baseline|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
10846106|NCT00273052|BG001|Baseline|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
10846107|NCT00273052|BG002|Baseline|Total|Total of all reporting groups
10846108|NCT00273052|FG000|Participant Flow|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
10846109|NCT00273052|FG001|Participant Flow|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
10846110|NCT00273052|OG000|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
10846111|NCT00273052|OG001|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
10846112|NCT00273052|EG000|Reported Event|Coreg CR|Results include only treatment emergent events.
10846113|NCT00273052|EG001|Reported Event|Toprol XL|Results include only treatment emergent events.
10846114|NCT00273182|BG000|Baseline|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
10867517|NCT00397215|OG001|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
10867518|NCT00397215|OG002|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867519|NCT00397215|OG003|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867520|NCT00397215|OG001|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867521|NCT00397215|OG001|Outcome|GSK1562902A 2 Group|GSK1562902A 2 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
10867522|NCT00397215|OG002|Outcome|GSK1562902A 3 Group|GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867523|NCT00397215|EG000|Reported Event|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
10867524|NCT00397215|EG001|Reported Event|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
10867525|NCT00397215|EG002|Reported Event|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867526|NCT00397215|EG003|Reported Event|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
10867527|NCT00397462|BG000|Baseline|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
10867528|NCT00397462|BG001|Baseline|Group 2 High Use|requested that they use the intervention as much as possible during the work day
10867529|NCT00397462|BG002|Baseline|Control|No use of the intervention
10867530|NCT00397462|BG003|Baseline|Total|Total of all reporting groups
10867531|NCT00397462|FG000|Participant Flow|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
10867532|NCT00397462|FG001|Participant Flow|Group 2 High Use|requested that they use the intervention as much as possible during the work day
10867533|NCT00397462|FG002|Participant Flow|Control|No intervention
10867534|NCT00397462|OG000|Outcome|Control|No change to usual behavior
10867535|NCT00397462|OG001|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
10867536|NCT00397462|OG002|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
10867537|NCT00397462|EG000|Reported Event|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
10867538|NCT00397462|EG001|Reported Event|Group 2 High Use|requested that they use the intervention as much as possible during the work day
10867539|NCT00397462|EG002|Reported Event|Control|did not use the intervention
10867540|NCT00397488|BG000|Baseline|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
10867541|NCT00397488|FG000|Participant Flow|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
10867542|NCT00397488|OG000|Outcome|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
10867543|NCT00397488|EG000|Reported Event|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
10867544|NCT00397514|BG000|Baseline|Congenital Heart Disease Patients|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
10867545|NCT00397514|FG000|Participant Flow|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
10867546|NCT00397514|OG000|Outcome|Baseline|Cardiac Index at baseline.
10867547|NCT00397514|OG001|Outcome|BiV Pacing|Cardiac Index when patient's extubation with 20 min. of biventricular pacing
10867548|NCT00397514|OG002|Outcome|RV Pacing|Cardiac Index when patient's extubation with 20 min. of right ventricular pacing
10867549|NCT00397514|OG000|Outcome|Baseline|QRS duration at baseline
10867550|NCT00397514|OG001|Outcome|BiV Pacing|QRS duration when patient's extubation with 20 min. of biventricular pacing
10867551|NCT00397514|OG002|Outcome|RV Pacing|QRS duration when patient's extubation with 20 min. of right ventricular pacing
10867552|NCT00397514|OG000|Outcome|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
10867553|NCT00397514|EG000|Reported Event|Pacing Protocol and RV Pacing|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
10867554|NCT00397540|BG000|Baseline|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
10867555|NCT00397540|BG001|Baseline|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
10867556|NCT00397540|BG002|Baseline|Total|Total of all reporting groups
10867557|NCT00397540|FG000|Participant Flow|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
10867558|NCT00397540|FG001|Participant Flow|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
10867559|NCT00397540|OG000|Outcome|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
10867560|NCT00397540|OG001|Outcome|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
10867561|NCT00397540|OG000|Outcome|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
10867562|NCT00397540|EG000|Reported Event|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
10867563|NCT00397540|EG001|Reported Event|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
11336547|NCT03568500|FG001|Participant Flow|Olanzapine|Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
10867564|NCT00397579|BG000|Baseline|SL-401|"Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.~DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days."
10867565|NCT00397579|FG000|Participant Flow|SL-401|"Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.~DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days."
10867566|NCT00397579|OG000|Outcome|SL-401|"Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.~DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days."
10867567|NCT00397579|EG000|Reported Event|SL-401|"Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.~DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days."
10867568|NCT00397631|BG000|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
10867569|NCT00397631|BG001|Baseline|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
10867570|NCT00397631|BG002|Baseline|Total|Total of all reporting groups
10867571|NCT00397631|FG000|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
10867572|NCT00397631|FG001|Participant Flow|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
10867573|NCT00397631|OG000|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
10867574|NCT00397631|OG001|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
10867575|NCT00397631|EG000|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
10867576|NCT00397631|EG001|Reported Event|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
10867577|NCT00397813|BG000|Baseline|Arm A - Dose Level 1|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10879160|NCT00455741|OG001|Outcome|Older Postmenopausal Women|"Graded estradiol infusion to young postmenopausal women. Graded progesterone infusion to young postmenopausal women..~Estradiol infusion: Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10867578|NCT00397813|BG001|Baseline|Arm A - Dose Level 2|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867579|NCT00397813|BG002|Baseline|Arm A - Dose Level 3|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867580|NCT00397813|BG003|Baseline|Arm B - Dose Level 1|"Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867581|NCT00397813|BG004|Baseline|Arm B - Dose Level 2|"Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867582|NCT00397813|BG005|Baseline|Arm B - Dose Level 3|"Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867583|NCT00397813|BG006|Baseline|Total|Total of all reporting groups
10867584|NCT00397813|FG000|Participant Flow|Arm A - Dose Level 1|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867585|NCT00397813|FG001|Participant Flow|Arm A - Dose Level 2|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867586|NCT00397813|FG002|Participant Flow|Arm A - Dose Level 3|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10879161|NCT00455741|OG000|Outcome|Baseline Pituitary|18 FDG uptake at the pituitary at baseline
10879162|NCT00455741|OG001|Outcome|Negative Feedback Pituitary|18 FDG uptake at the pituitary at 24 hr associated with estrogen induced negative feedback on LH
10879163|NCT00455741|OG000|Outcome|Baseline Hypothalamus|18 FDG uptake at the hypothalamus at baseline
10879164|NCT00455741|OG001|Outcome|Negative Feedback Hypothalamus|18 FDG uptake at the at the hypothalamus at 24 hr associated with estrogen induced negative feedback on LH
10879165|NCT00455741|OG000|Outcome|Pituitary at 24 hr|18 FDG uptake at the pituitary at 24 hr
10867587|NCT00397813|FG003|Participant Flow|Arm B - Dose Level 1|"Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867588|NCT00397813|FG004|Participant Flow|Arm B - Dose Level 2|"Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867589|NCT00397813|FG005|Participant Flow|Arm B - Dose Level 3|"Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867590|NCT00397813|OG000|Outcome|Arm A - Dose Level 1|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867591|NCT00397813|OG001|Outcome|Arm A - Dose Level 2|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867592|NCT00397813|OG002|Outcome|Arm A - Dose Level 3|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867593|NCT00397813|OG003|Outcome|Arm B - Dose Level 1|"Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867594|NCT00397813|OG004|Outcome|Arm B - Dose Level 2|"Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867595|NCT00397813|OG005|Outcome|Arm B - Dose Level 3|"Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867596|NCT00397813|EG000|Reported Event|Arm A - Dose Level 1|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867597|NCT00397813|EG001|Reported Event|Arm A - Dose Level 2|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867598|NCT00397813|EG002|Reported Event|Arm A - Dose Level 3|"Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867599|NCT00397813|EG003|Reported Event|Arm B - Dose Level 1|"Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867600|NCT00397813|EG004|Reported Event|Arm B - Dose Level 2|"Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867601|NCT00397813|EG005|Reported Event|Arm B - Dose Level 3|"Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI~NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0.~IMMUNOSUPPRESSION:~Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27.~Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96."
10867602|NCT00397839|BG000|Baseline|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
10867603|NCT00397839|BG001|Baseline|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
10867604|NCT00397839|BG002|Baseline|Total|Total of all reporting groups
10867605|NCT00397839|FG000|Participant Flow|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
10867606|NCT00397839|FG001|Participant Flow|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
10867607|NCT00397839|OG000|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
10867608|NCT00397839|OG001|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
10867609|NCT00397839|EG000|Reported Event|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
10867610|NCT00397839|EG001|Reported Event|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
10867611|NCT00397878|BG000|Baseline|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10867612|NCT00397878|FG000|Participant Flow|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10867613|NCT00397878|OG000|Outcome|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10867614|NCT00397878|EG000|Reported Event|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10867615|NCT00397891|BG000|Baseline|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
10867616|NCT00397891|BG001|Baseline|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
10867617|NCT00397891|BG002|Baseline|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
10867618|NCT00397891|BG003|Baseline|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
10867619|NCT00397891|BG004|Baseline|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
10867620|NCT00397891|BG005|Baseline|Total|Total of all reporting groups
10867621|NCT00397891|FG000|Participant Flow|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
10867622|NCT00397891|FG001|Participant Flow|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
10867623|NCT00397891|FG002|Participant Flow|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
10867624|NCT00397891|FG003|Participant Flow|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
10867625|NCT00397891|FG004|Participant Flow|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
10867626|NCT00397891|OG000|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
10867627|NCT00397891|OG001|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
10867628|NCT00397891|OG002|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
10867629|NCT00397891|OG003|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
10867630|NCT00397891|OG004|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
10867631|NCT00397891|EG000|Reported Event|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
10867632|NCT00397891|EG001|Reported Event|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
10867633|NCT00397891|EG002|Reported Event|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
10867634|NCT00397891|EG003|Reported Event|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
10867635|NCT00397891|EG004|Reported Event|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
10867636|NCT00397904|BG000|Baseline|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
10867637|NCT00397904|FG000|Participant Flow|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
10867638|NCT00397904|OG000|Outcome|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
10867639|NCT00397904|EG000|Reported Event|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
10879166|NCT00455741|OG001|Outcome|Pituitary at 72 hr|18 FDG uptake at the pituitary at 72 hr associated with estrogen induced positive feedback on LH
10879167|NCT00455741|OG000|Outcome|Hypothalamus at 24 hr|18 FDG uptake at the hypothalamus at 24 hr
10879168|NCT00455741|OG001|Outcome|Hypothalamus 72 hr|18 FDG uptake at the pituitary at 72 hr associated with estrogen induced positive feedback on LH
10879169|NCT00455741|EG000|Reported Event|Younger PMW|"Postmenopausal women (PMW) ages 45-55 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10879170|NCT00455741|EG001|Reported Event|Older PMW|"Postmenopausal women (PMW) ages 70-80 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
10879171|NCT00455858|BG000|Baseline|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
10879172|NCT00455858|FG000|Participant Flow|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
11336548|NCT03568500|FG002|Participant Flow|Quetiapine|Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
10867640|NCT00397930|BG000|Baseline|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
10867641|NCT00397930|BG001|Baseline|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
10867642|NCT00397930|BG002|Baseline|Total|Total of all reporting groups
10867643|NCT00397930|FG000|Participant Flow|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
10867644|NCT00397930|FG001|Participant Flow|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
10867645|NCT00397930|OG000|Outcome|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
10867646|NCT00397930|OG001|Outcome|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
10867647|NCT00397930|EG000|Reported Event|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
10867648|NCT00397930|EG001|Reported Event|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
10867649|NCT00397943|BG000|Baseline|M72/AS01B Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867650|NCT00397943|BG001|Baseline|M72/AS02A Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867651|NCT00397943|BG002|Baseline|Mtb72F/AS02A Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867652|NCT00397943|BG003|Baseline|Non-adjuvanted Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867653|NCT00397943|BG004|Baseline|Control Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867654|NCT00397943|BG005|Baseline|Total|Total of all reporting groups
10867655|NCT00397943|FG000|Participant Flow|M72/AS01B Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867656|NCT00397943|FG001|Participant Flow|M72/AS02A Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867657|NCT00397943|FG002|Participant Flow|Mtb72F/AS02A Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867658|NCT00397943|FG003|Participant Flow|Non-adjuvanted Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867659|NCT00397943|FG004|Participant Flow|Control Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867660|NCT00397943|OG000|Outcome|M72/AS01B Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867661|NCT00397943|OG001|Outcome|M72/AS02A Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867662|NCT00397943|OG002|Outcome|Mtb72F/AS02A Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867663|NCT00397943|OG003|Outcome|Non-adjuvanted Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867664|NCT00397943|OG004|Outcome|Control Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867665|NCT00397943|EG000|Reported Event|M72/AS01B Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867666|NCT00397943|EG001|Reported Event|M72/AS02A Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867667|NCT00397943|EG002|Reported Event|Mtb72F/AS02A Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867668|NCT00397943|EG003|Reported Event|Non-adjuvanted Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867669|NCT00397943|EG004|Reported Event|Control Group|Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
10867670|NCT00397982|BG000|Baseline|Entire Study|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
10867671|NCT00397982|FG000|Participant Flow|Treatment (Enzyme Inhibitor, Monoclonal Antibody)|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
10867672|NCT00397982|OG000|Outcome|Entire Study|Treatment
10867673|NCT00397982|OG000|Outcome|Entire Study|17 participants
10867674|NCT00397982|EG000|Reported Event|Entire Study|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
10867675|NCT00398047|BG000|Baseline|Azacitidine and Darbopoietin and G-CSF|
10867676|NCT00398047|FG000|Participant Flow|Combination of Azacitadine and Hematopoietic Growth Factors|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
10867677|NCT00398047|OG000|Outcome|Azacitidine and Darbopoietin and G-CSF|
10867678|NCT00398047|OG000|Outcome|Azacitidine and Darbopoietin and G-CSF|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
10867679|NCT00398047|EG000|Reported Event|Azacitidine and Darbopoietin and G-CSF|
10867680|NCT00398073|BG000|Baseline|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
10867681|NCT00398073|BG001|Baseline|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
10867682|NCT00398073|BG002|Baseline|Total|Total of all reporting groups
10867683|NCT00398073|FG000|Participant Flow|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
10867684|NCT00398073|FG001|Participant Flow|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
10867685|NCT00398073|OG000|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
10867686|NCT00398073|OG001|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
10867687|NCT00398073|EG000|Reported Event|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
10867688|NCT00398073|EG001|Reported Event|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
10867689|NCT00398086|BG000|Baseline|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
10867690|NCT00398086|BG001|Baseline|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
10867691|NCT00398086|BG002|Baseline|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
10867692|NCT00398086|BG003|Baseline|Total|Total of all reporting groups
10867693|NCT00398086|FG000|Participant Flow|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
10867694|NCT00398086|FG001|Participant Flow|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
10867695|NCT00398086|FG002|Participant Flow|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
10867696|NCT00398086|OG000|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
10867697|NCT00398086|OG001|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
10867698|NCT00398086|OG002|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
10867699|NCT00398086|EG000|Reported Event|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
10867700|NCT00398086|EG001|Reported Event|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
10867701|NCT00398086|EG002|Reported Event|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
10867702|NCT00398112|BG000|Baseline|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10867703|NCT00398112|FG000|Participant Flow|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10846115|NCT00273182|FG000|Participant Flow|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
10846116|NCT00273182|OG000|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
10846117|NCT00273182|OG000|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
10846118|NCT00273182|EG000|Reported Event|All Patients|The analysis included data from all subjects enrolled in the InSync Registry study.
10846119|NCT00273364|BG000|Baseline|Hematopoietic Stem Cell Transplantation|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with Cyclophosphamide and rATG~Hematopoietic Stem Cell Therapy: After mobilization and harvest of stem cells, stem cells will be infused following conditioning regimen"
10846120|NCT00273364|BG001|Baseline|Standard Therapy for MS|"Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), Gilenya (fingolimod) or Dimethyl fumarate (Tecfidera or BG-12)~Standard treatment with a conventional drug: Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), or Gilenya (fingolimod)"
10846121|NCT00273364|BG002|Baseline|Total|Total of all reporting groups
10846122|NCT00273364|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with Cyclophosphamide and rATG~Hematopoietic Stem Cell Therapy: After mobilization and harvest of stem cells, stem cells will be infused following conditioning regimen"
10846123|NCT00273364|FG001|Participant Flow|Standard Therapy for MS|"Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), Gilenya (fingolimod) or Dimethyl fumarate (Tecfidera or BG-12)~Standard treatment with a conventional drug: Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), or Gilenya (fingolimod)"
10846124|NCT00273364|OG000|Outcome|Hematopoietic Stem Cell Transplantation|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with Cyclophosphamide and rATG~Hematopoietic Stem Cell Therapy: After mobilization and harvest of stem cells, stem cells will be infused following conditioning regimen"
10846125|NCT00273364|OG001|Outcome|Standard Therapy for MS|"Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), Gilenya (fingolimod) or Dimethyl fumarate (Tecfidera or BG-12)~Standard treatment with a conventional drug: Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), or Gilenya (fingolimod)"
10846126|NCT00273364|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with Cyclophosphamide and rATG~Hematopoietic Stem Cell Therapy: After mobilization and harvest of stem cells, stem cells will be infused following conditioning regimen"
10846127|NCT00273364|EG001|Reported Event|Standard Therapy for MS|"Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), Gilenya (fingolimod) or Dimethyl fumarate (Tecfidera or BG-12)~Standard treatment with a conventional drug: Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), or Gilenya (fingolimod)"
10846128|NCT00273754|BG000|Baseline|Placebo|Normal Saline
10846129|NCT00273754|BG001|Baseline|Caffeine|Caffeine benzoate
10846130|NCT00273754|BG002|Baseline|Total|Total of all reporting groups
10846131|NCT00273754|FG000|Participant Flow|Placebo|Normal Saline
10846132|NCT00273754|FG001|Participant Flow|Caffeine|Caffeine benzoate
10846133|NCT00273754|OG000|Outcome|Placebo|Normal Saline
10846134|NCT00273754|OG001|Outcome|Caffeine|Caffeine benzoate
10846135|NCT00273754|EG000|Reported Event|Placebo|Normal Saline
10846136|NCT00273754|EG001|Reported Event|Caffeine|Caffeine benzoate
10846137|NCT00273793|BG000|Baseline|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
10846138|NCT00273793|BG001|Baseline|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
10846139|NCT00273793|BG002|Baseline|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
10867704|NCT00398112|OG000|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10867705|NCT00398112|EG000|Reported Event|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10867706|NCT00398138|BG000|Baseline|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
10867707|NCT00398138|FG000|Participant Flow|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
10867708|NCT00398138|OG000|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
10867709|NCT00398138|EG000|Reported Event|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
10867710|NCT00398216|BG000|Baseline|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
10867711|NCT00398216|BG001|Baseline|Edoxaban 30mg QD|edoxaban 30mg QD PO
10867712|NCT00398216|BG002|Baseline|Edoxaban 60mg QD|edoxaban 60mg QD PO
10867713|NCT00398216|BG003|Baseline|Edoxaban 90mg QD|edoxaban 90mg QD PO
10867714|NCT00398216|BG004|Baseline|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
10867715|NCT00398216|BG005|Baseline|Total|Total of all reporting groups
10867716|NCT00398216|FG000|Participant Flow|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
10867717|NCT00398216|FG001|Participant Flow|Edoxaban 30mg QD|edoxaban 30mg QD PO
10867718|NCT00398216|FG002|Participant Flow|Edoxaban 60mg QD|edoxaban 60mg QD PO
10867719|NCT00398216|FG003|Participant Flow|Edoxaban 90mg QD|edoxaban 90mg QD PO
10867720|NCT00398216|FG004|Participant Flow|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
10867721|NCT00398216|OG000|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
10867722|NCT00398216|OG001|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
10867723|NCT00398216|OG002|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
10867724|NCT00398216|OG003|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
10867725|NCT00398216|OG004|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
10867726|NCT00398216|EG000|Reported Event|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
10867727|NCT00398216|EG001|Reported Event|Edoxaban 30mg QD|edoxaban 30mg QD PO
10867728|NCT00398216|EG002|Reported Event|Edoxaban 60mg QD|edoxaban 60mg QD PO
10867729|NCT00398216|EG003|Reported Event|Edoxaban 90mg QD|edoxaban 90mg QD PO
10867730|NCT00398216|EG004|Reported Event|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
10867731|NCT00398320|BG000|Baseline|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
10867732|NCT00398320|FG000|Participant Flow|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~Adverse events (AEs) reported are related and grade 3 or higher per CTCAE version 3."
10867733|NCT00398320|OG000|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
10867734|NCT00398320|EG000|Reported Event|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
10867735|NCT00398398|BG000|Baseline|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
10867736|NCT00398398|FG000|Participant Flow|Xelox Plus Cetuximab|"Capecitabine, oxaliplatin and cetuximab~cetuximab : initial loading dose of 400 mg/m2, maintenance dose of 250 mg/m2 (every week) Oxaliplatin : 130 mg/m2 (every 3 weeks) capecitabine :1,000 mg/m2 (days 1-14)"
10867737|NCT00398398|OG000|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
10867738|NCT00398398|EG000|Reported Event|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
10867739|NCT00398411|BG000|Baseline|Moxifloxacin|moxifloxacin 400 mg tablets once daily
10867740|NCT00398411|BG001|Baseline|Placebo|identical appearing placebo
10867741|NCT00398411|BG002|Baseline|Total|Total of all reporting groups
10867742|NCT00398411|FG000|Participant Flow|Moxifloxacin|moxifloxacin 400 mg tablets once daily
10867743|NCT00398411|FG001|Participant Flow|Placebo|identical appearing placebo
10867744|NCT00398411|OG000|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
10867745|NCT00398411|OG001|Outcome|Placebo|identical appearing placebo
10867746|NCT00398411|EG000|Reported Event|Moxifloxacin|moxifloxacin 400 mg tablets once daily
10867747|NCT00398411|EG001|Reported Event|Placebo|identical appearing placebo
10867748|NCT00398476|BG000|Baseline|Overall Study Arm|Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg/FF 110 µg or FF 110 µg/FP 200 µgin a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
10867749|NCT00398476|FG000|Participant Flow|FF 110 µg /FP 200 µg|In this sequence, participants received a single-dose treatment fluticasone furoate (FF) 110 micrograms (µg) in period 1 and fluticasone propionate (FP) 200 µg in period 2 (2 sprays per nostril - 4 sprays in total) for 30 minutes. Each spray of the suspension was containing approximately 27.5 µg of FF and each actuation delivered 50 µg of FP in 100 milligram (mg) of formulation through the nasal adapter. There was a washout period of 20 minutes in between the 2 periods.
10867750|NCT00398476|FG001|Participant Flow|FP 200 µg /FF 110 µg|In this sequence, participants received a single-dose treatment FP 200 µg in period 1 and FF 110 µg in period 2 (2 sprays per nostril - 4 sprays in total) for 30 minutes. Each spray of the suspension was containing approximately 27.5 µg of FF and Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter. There was a washout period of 20 minutes in between the 2 periods.
10867751|NCT00398476|OG000|Outcome|Overall Study Arm|Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
11348757|NCT04136444|FG001|Participant Flow|Cohort B|Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
10867752|NCT00398476|OG000|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
10867753|NCT00398476|OG001|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
10867754|NCT00398476|OG001|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study
10867755|NCT00398476|EG000|Reported Event|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
10846140|NCT00273793|BG003|Baseline|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
10846141|NCT00273793|BG004|Baseline|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
10846142|NCT00273793|BG005|Baseline|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
10846143|NCT00273793|BG006|Baseline|Total|Total of all reporting groups
10846144|NCT00273793|FG000|Participant Flow|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
10846145|NCT00273793|FG001|Participant Flow|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
10846146|NCT00273793|FG002|Participant Flow|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
10846147|NCT00273793|FG003|Participant Flow|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
10846148|NCT00273793|FG004|Participant Flow|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
10846149|NCT00273793|FG005|Participant Flow|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
10846150|NCT00273793|OG000|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
10846151|NCT00273793|OG001|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
10846152|NCT00273793|OG002|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
10846153|NCT00273793|OG003|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
10846154|NCT00273793|OG004|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
10846155|NCT00273793|OG005|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
10846156|NCT00273793|EG000|Reported Event|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
10846157|NCT00273793|EG001|Reported Event|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
10846158|NCT00273793|EG002|Reported Event|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
10846159|NCT00273793|EG003|Reported Event|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
10846160|NCT00273793|EG004|Reported Event|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
10846161|NCT00273793|EG005|Reported Event|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
10846162|NCT00273858|BG000|Baseline|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
10846163|NCT00273858|FG000|Participant Flow|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
10846164|NCT00273858|OG000|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
10846165|NCT00273858|EG000|Reported Event|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
10846166|NCT00273910|BG000|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846167|NCT00273910|BG001|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
10846168|NCT00273910|BG002|Baseline|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10867756|NCT00398476|EG001|Reported Event|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
10867757|NCT00398567|BG000|Baseline|Neratinib 160 mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 160 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867758|NCT00398567|BG001|Baseline|Neratinib 240 mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 160 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867759|NCT00398567|BG002|Baseline|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867760|NCT00398567|BG003|Baseline|Total|Total of all reporting groups
10867761|NCT00398567|FG000|Participant Flow|Neratinib 160mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 160 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867762|NCT00398567|FG001|Participant Flow|Neratinib 240mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867763|NCT00398567|FG002|Participant Flow|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867764|NCT00398567|OG000|Outcome|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867765|NCT00398567|EG000|Reported Event|Neratinib 160 mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 160 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867766|NCT00398567|EG001|Reported Event|Neratinib 240 mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867767|NCT00398567|EG002|Reported Event|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
10867768|NCT00398632|BG000|Baseline|Duloxetine|Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks
10867769|NCT00398632|FG000|Participant Flow|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
10867770|NCT00398632|OG000|Outcome|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
10867771|NCT00398632|OG000|Outcome|Duloxetine|Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks
10867772|NCT00398632|EG000|Reported Event|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
10867773|NCT00398866|BG000|Baseline|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
10867774|NCT00398866|BG001|Baseline|Triamcinolone|"Corticosteroid (trimcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
10867775|NCT00398866|BG002|Baseline|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
10867776|NCT00398866|BG003|Baseline|Total|Total of all reporting groups
10867777|NCT00398866|FG000|Participant Flow|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
10867778|NCT00398866|FG001|Participant Flow|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
10867779|NCT00398866|FG002|Participant Flow|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
10867780|NCT00398866|OG000|Outcome|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
10867781|NCT00398866|OG001|Outcome|Triamcinolone|"Corticosteroid (trimcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
10867782|NCT00398866|OG002|Outcome|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
10867783|NCT00398866|OG001|Outcome|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
10867784|NCT00398866|EG000|Reported Event|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
10867785|NCT00398866|EG001|Reported Event|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
10867786|NCT00398866|EG002|Reported Event|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
10867787|NCT00398918|BG000|Baseline|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
10867788|NCT00398918|FG000|Participant Flow|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
10867789|NCT00398918|OG000|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
10867790|NCT00398918|EG000|Reported Event|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
10867791|NCT00398983|BG000|Baseline|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
10867792|NCT00398983|BG001|Baseline|No Study Drug|Continue current therapy.
10867793|NCT00398983|BG002|Baseline|Total|Total of all reporting groups
10867794|NCT00398983|FG000|Participant Flow|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
10867795|NCT00398983|FG001|Participant Flow|No Study Drug|Continue current therapy.
10867796|NCT00398983|OG000|Outcome|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
10867797|NCT00398983|OG001|Outcome|No Study Drug|Continue current therapy.
10867798|NCT00398983|EG000|Reported Event|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
10867799|NCT00398983|EG001|Reported Event|No Study Drug|Continue current therapy.
10867800|NCT00399035|BG000|Baseline|Cediranib 20 mg|Cediranib 20 mg + FOLFOX/XELOX
10867801|NCT00399035|BG001|Baseline|Placebo|Placebo + FOLFOX/XELOX
10867802|NCT00399035|BG002|Baseline|Cediranib 30 mg|Cediranib 30 mg/day + FOLFOX/XELOX
10867803|NCT00399035|BG003|Baseline|Total|Total of all reporting groups
10867804|NCT00399035|FG000|Participant Flow|Cediranib 20 mg/Day|[Cediranib 20mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
10867805|NCT00399035|FG001|Participant Flow|Cediranib 30 mg/Day|[Cediranib 30mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
10867806|NCT00399035|FG002|Participant Flow|Placebo|[Placebo +FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
10867807|NCT00399035|OG000|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
10867808|NCT00399035|OG001|Outcome|Placebo|Placebo + FOLFOX/XELOX
10867809|NCT00399035|EG000|Reported Event|Cediranib 30mg|Cediranib 30mg/day + Folfox/Xelox
10867810|NCT00399035|EG001|Reported Event|Cediranib 20mg|Cediranib 20mg/day + Folfox/Xelox
10867811|NCT00399035|EG002|Reported Event|Placebo|Placebo + Folfox/Xelox
10867812|NCT00399308|BG000|Baseline|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
10867813|NCT00399308|BG001|Baseline|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
10867814|NCT00399308|BG002|Baseline|Group III - Control|Adaptic and Profore four-layer compression dressing
10867815|NCT00399308|BG003|Baseline|Total|Total of all reporting groups
10867816|NCT00399308|FG000|Participant Flow|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
10867817|NCT00399308|FG001|Participant Flow|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
10867818|NCT00399308|FG002|Participant Flow|Group III - Control|Adaptic and Profore four-layer compression dressing
10867819|NCT00399308|OG000|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
10867820|NCT00399308|OG001|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
10867821|NCT00399308|OG002|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
10867822|NCT00399308|EG000|Reported Event|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
10867823|NCT00399308|EG001|Reported Event|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
10867824|NCT00399308|EG002|Reported Event|Group III - Control|Adaptic and Profore four-layer compression dressing
10867825|NCT00399360|BG000|Baseline|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867826|NCT00399360|BG001|Baseline|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867827|NCT00399360|BG002|Baseline|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867828|NCT00399360|BG003|Baseline|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867829|NCT00399360|BG004|Baseline|Total|Total of all reporting groups
10867830|NCT00399360|FG000|Participant Flow|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867831|NCT00399360|FG001|Participant Flow|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867832|NCT00399360|FG002|Participant Flow|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867833|NCT00399360|FG003|Participant Flow|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867834|NCT00399360|OG000|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867835|NCT00399360|OG001|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867836|NCT00399360|OG002|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867837|NCT00399360|OG003|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867838|NCT00399360|OG000|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
10867839|NCT00399360|OG001|Outcome|Lifestyle Modification and Placebo|
10867840|NCT00399360|OG002|Outcome|No Lifestyle Modification and Metformin|
10867841|NCT00399360|OG003|Outcome|Lifestyle Modification and Metformin|
10867842|NCT00399360|OG000|Outcome|No Lifestyle Modification and Placebo|
10867843|NCT00399360|EG000|Reported Event|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867844|NCT00399360|EG001|Reported Event|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867845|NCT00399360|EG002|Reported Event|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867846|NCT00399360|EG003|Reported Event|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
10867847|NCT00399490|BG000|Baseline|Tanezumab 50 mcg/kg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
10867848|NCT00399490|FG000|Participant Flow|Tanezumab 50 mcg/kg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
10867849|NCT00399490|OG000|Outcome|Tanezumab 50 mcg/kg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
10867850|NCT00399490|OG000|Outcome|Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)|Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
10867851|NCT00399490|OG001|Outcome|Tanezumab 50 mcg/kg (Previous Placebo Treatment)|Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
10867852|NCT00399490|EG000|Reported Event|Tanezumab 50 mcg/kg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
10867853|NCT00399516|BG000|Baseline|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
10867854|NCT00399516|FG000|Participant Flow|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
10867855|NCT00399516|OG000|Outcome|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
10867856|NCT00399516|EG000|Reported Event|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
10867857|NCT00399529|BG000|Baseline|Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide|"Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.~Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study~Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously"
10867858|NCT00399529|FG000|Participant Flow|Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide|"Allogeneic granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting breast cancer vaccine: the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.~Cyclophosphamide (Cy): 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study~Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously"
10867859|NCT00399529|OG000|Outcome|Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide|"Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.~Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study~Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously"
10867860|NCT00399529|OG000|Outcome|Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide|"Allogeneic GM-CSF-secreting breast cancer vaccine :~5 X 10^8 cells given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.~Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study~Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously"
10879173|NCT00455858|OG000|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
10879174|NCT00455858|EG000|Reported Event|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
10867861|NCT00399529|EG000|Reported Event|Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide|"Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.~Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study~Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously"
10867862|NCT00399542|BG000|Baseline|Lubiprostone|Subjects who received active drug
10867863|NCT00399542|BG001|Baseline|Placebo|Subjects who received placebo
10867864|NCT00399542|BG002|Baseline|Total|Total of all reporting groups
10867865|NCT00399542|FG000|Participant Flow|Lubiprostone|Subjects who received active drug
10867866|NCT00399542|FG001|Participant Flow|Placebo|Subjects who received placebo
10867867|NCT00399542|OG000|Outcome|Lubiprostone|Subjects who received active drug
10867868|NCT00399542|OG001|Outcome|Placebo|Subjects who received placebo
10867869|NCT00399542|EG000|Reported Event|Lubiprostone|Subjects who received active drug
10867870|NCT00399542|EG001|Reported Event|Placebo|Subjects who received placebo
10867871|NCT00399568|BG000|Baseline|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
10867872|NCT00399568|BG001|Baseline|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
10867873|NCT00399568|BG002|Baseline|Total|Total of all reporting groups
10867874|NCT00399568|FG000|Participant Flow|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
10867875|NCT00399568|FG001|Participant Flow|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
10867876|NCT00399568|OG000|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
10867877|NCT00399568|OG001|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
10867878|NCT00399568|OG000|Outcome|IV Acetaminophen 1g/100 ml Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 ml solution)
10867879|NCT00399568|OG001|Outcome|IV Placebo 100 ml Solution|Safety Population(defined as those subjects who received any portion of a dose of IV Placebo 100 ml solution)
10867880|NCT00399568|EG000|Reported Event|IV Acetaminophen 1g/100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 mL solution)
10867881|NCT00399568|EG001|Reported Event|IV Placebo 100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV Placebo 100 mL solution)
10867882|NCT00399763|BG000|Baseline|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
10867883|NCT00399763|BG001|Baseline|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
10867884|NCT00399763|BG002|Baseline|Total|Total of all reporting groups
10867885|NCT00399763|FG000|Participant Flow|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
10867886|NCT00399763|FG001|Participant Flow|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
10867887|NCT00399763|OG000|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
10867888|NCT00399763|OG001|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
10867889|NCT00399763|EG000|Reported Event|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
10867890|NCT00399763|EG001|Reported Event|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
10867891|NCT00399802|BG000|Baseline|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
10867892|NCT00399802|BG001|Baseline|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
10867893|NCT00399802|BG002|Baseline|Total|Total of all reporting groups
10867894|NCT00399802|FG000|Participant Flow|Single Intravenous (IV) Infusion of Zoledronic Acid (ZA) 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
10867895|NCT00399802|FG001|Participant Flow|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
10867896|NCT00399802|OG000|Outcome|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
10867897|NCT00399802|OG001|Outcome|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
10867898|NCT00399802|EG000|Reported Event|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
10867899|NCT00399802|EG001|Reported Event|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
10867900|NCT00399880|BG000|Baseline|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
10867901|NCT00399880|BG001|Baseline|Usual Care|Usual care arm
10867902|NCT00399880|BG002|Baseline|Total|Total of all reporting groups
10867903|NCT00399880|FG000|Participant Flow|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
10867904|NCT00399880|FG001|Participant Flow|Usual Care|Usual care arm
10867905|NCT00399880|OG000|Outcome|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
10867906|NCT00399880|OG001|Outcome|Usual Care|Usual care arm
10867907|NCT00399880|EG000|Reported Event|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
10867908|NCT00399880|EG001|Reported Event|Usual Care|Usual care (Standard)
10867909|NCT00399893|BG000|Baseline|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
10867910|NCT00399893|BG001|Baseline|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
11348758|NCT04136444|OG000|Outcome|Cohort A (PKS)|Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
10867911|NCT00399893|BG002|Baseline|Total|Total of all reporting groups
10867912|NCT00399893|FG000|Participant Flow|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
10867913|NCT00399893|FG001|Participant Flow|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
10867914|NCT00399893|OG000|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
10867915|NCT00399893|OG001|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
10867916|NCT00399893|EG000|Reported Event|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
10867917|NCT00399893|EG001|Reported Event|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
10867918|NCT00400153|BG000|Baseline|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
10867919|NCT00400153|BG001|Baseline|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
10867920|NCT00400153|BG002|Baseline|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
10867921|NCT00400153|BG003|Baseline|Total|Total of all reporting groups
10867922|NCT00400153|FG000|Participant Flow|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
10867923|NCT00400153|FG001|Participant Flow|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
10867924|NCT00400153|FG002|Participant Flow|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
10867925|NCT00400153|OG000|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
10867926|NCT00400153|OG001|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
10867927|NCT00400153|OG002|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
10867928|NCT00400153|OG000|Outcome|MDI Device|MDI Inhalers
10867929|NCT00400153|OG001|Outcome|RESPIMAT Device|Respimat Inhalers
10867930|NCT00400153|OG000|Outcome|Number of Patients|Total number of patients due to device preference
10867931|NCT00400153|OG000|Outcome|Number of Patients|Total number of patients due to rating of turning
10867932|NCT00400153|OG002|Outcome|Ipratropium Respimat 20 Mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
10867933|NCT00400153|EG000|Reported Event|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
10867934|NCT00400153|EG001|Reported Event|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
10867935|NCT00400153|EG002|Reported Event|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
10867936|NCT00400179|BG000|Baseline|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
10867937|NCT00400179|BG001|Baseline|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
10867938|NCT00400179|BG002|Baseline|Total|Total of all reporting groups
10867939|NCT00400179|FG000|Participant Flow|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
10867940|NCT00400179|FG001|Participant Flow|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
10867941|NCT00400179|OG000|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
10867942|NCT00400179|OG001|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
10867943|NCT00400179|EG000|Reported Event|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
10867944|NCT00400179|EG001|Reported Event|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
10867945|NCT00400205|BG000|Baseline|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
10867946|NCT00400205|FG000|Participant Flow|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
10867947|NCT00400205|OG000|Outcome|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
10867948|NCT00400205|OG000|Outcome|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
10867949|NCT00400205|EG000|Reported Event|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
10867950|NCT00400400|BG000|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
10867951|NCT00400400|BG001|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
10867952|NCT00400400|BG002|Baseline|Total|Total of all reporting groups
10867953|NCT00400400|FG000|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
10867954|NCT00400400|FG001|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
10867955|NCT00400400|OG000|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
10867956|NCT00400400|OG001|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
10867957|NCT00400400|EG000|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
10867958|NCT00400400|EG001|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
10867959|NCT00400439|BG000|Baseline|Dalcetrapib (RO4607381)|dalcetrapib (RO4607381): 900mg po daily for 24 weeks
10867960|NCT00400439|BG001|Baseline|Placebo|placebo: po daily for 24 weeks
10867961|NCT00400439|BG002|Baseline|Total|Total of all reporting groups
10867962|NCT00400439|FG000|Participant Flow|Dalcetrapib (RO4607381)|dalcetrapib (RO4607381): 900mg po daily for 24 weeks
10867963|NCT00400439|FG001|Participant Flow|Placebo|placebo: po daily for 24 weeks
10867964|NCT00400439|OG000|Outcome|Dalcetrapib (RO4607381)|dalcetrapib (RO4607381): 900mg po daily for 24 weeks
10867965|NCT00400439|OG001|Outcome|Placebo|placebo: po daily for 24 weeks
10867966|NCT00400439|EG000|Reported Event|Dalcetrapib (RO4607381)|dalcetrapib (RO4607381): 900mg po daily for 24 weeks
10867967|NCT00400439|EG001|Reported Event|Placebo|placebo: po daily for 24 weeks
10867968|NCT00400517|BG000|Baseline|GM-CSF Injections and Oral Thalidomide|"taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.~sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day~thalidomide: doses up to 400 mg/day~conventional surgery: SOC care surgery~neoadjuvant therapy: post radical prostatectomy"
10867969|NCT00400517|FG000|Participant Flow|GM-CSF Injections and Oral Thalidomide|"taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.~sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day~thalidomide: doses up to 400 mg/day~conventional surgery: SOC care surgery~neoadjuvant therapy: post radical prostatectomy"
10867970|NCT00400517|OG000|Outcome|GM-CSF Injections and Oral Thalidomide|"taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.~sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day~thalidomide: doses up to 400 mg/day~conventional surgery: SOC care surgery~neoadjuvant therapy: post radical prostatectomy"
10867971|NCT00400517|EG000|Reported Event|GM-CSF Injections and Oral Thalidomide|"taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.~sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day~thalidomide: doses up to 400 mg/day~conventional surgery: SOC care surgery~neoadjuvant therapy: post radical prostatectomy"
10867972|NCT00400569|BG000|Baseline|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
10867973|NCT00400569|FG000|Participant Flow|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
10867974|NCT00400569|OG000|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
10867975|NCT00400569|OG000|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
10867976|NCT00400569|OG001|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
10867977|NCT00400569|OG002|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
10867978|NCT00400569|EG000|Reported Event|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
10867979|NCT00400634|BG000|Baseline|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
10867980|NCT00400634|BG001|Baseline|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
10867981|NCT00400634|BG002|Baseline|Total|Total of all reporting groups
10867982|NCT00400634|FG000|Participant Flow|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
10867983|NCT00400634|FG001|Participant Flow|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
10867984|NCT00400634|OG000|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
10867985|NCT00400634|OG001|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
10867986|NCT00400634|EG000|Reported Event|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
10867987|NCT00400634|EG001|Reported Event|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
10867988|NCT00400686|BG000|Baseline|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
10867989|NCT00400686|FG000|Participant Flow|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
10867990|NCT00400686|OG000|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
10867991|NCT00400686|EG000|Reported Event|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
10867992|NCT00400712|BG000|Baseline|Control|natural progression post-stroke
10867993|NCT00400712|BG001|Baseline|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
10867994|NCT00400712|BG002|Baseline|Total|Total of all reporting groups
10867995|NCT00400712|FG000|Participant Flow|Control|no intervention, natural history following stroke
10867996|NCT00400712|FG001|Participant Flow|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year)
10867997|NCT00400712|OG000|Outcome|Control|natural progression post-stroke
10867998|NCT00400712|OG001|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
10867999|NCT00400712|OG000|Outcome|Control|no intervention, natural progression post-stroke
10868000|NCT00400712|OG001|Outcome|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months .
10868001|NCT00400712|EG000|Reported Event|Control|natural progression post-stroke
10868002|NCT00400712|EG001|Reported Event|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
10868003|NCT00400764|BG000|Baseline|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868004|NCT00400764|BG001|Baseline|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868005|NCT00400764|BG002|Baseline|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
10868006|NCT00400764|BG003|Baseline|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868007|NCT00400764|BG004|Baseline|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
10868008|NCT00400764|BG005|Baseline|Total|Total of all reporting groups
10868009|NCT00400764|FG000|Participant Flow|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868010|NCT00400764|FG001|Participant Flow|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868011|NCT00400764|FG002|Participant Flow|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
10868012|NCT00400764|FG003|Participant Flow|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868013|NCT00400764|FG004|Participant Flow|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
10868014|NCT00400764|OG000|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868015|NCT00400764|OG001|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868016|NCT00400764|OG002|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
10868017|NCT00400764|OG003|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868018|NCT00400764|OG004|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
11223182|NCT02351700|BG000|Baseline|Opioid-sparing Group|"Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.~IV Caldolor (IV Ibuprofen): Compare addition of IV Caldolor (IV ibuprofen) intraoperatively and postoperatively against IV ibuprofen placebo added intraoperatively and postoperatively."
11223183|NCT02351700|BG001|Baseline|Standard Treatment Group|"IV Caldolor placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.~IV Ibuprofen placebo: Compare addition of IV ibuprofen placebo intraoperatively and postoperatively against IV Caldolor (IV ibuprofen) added intraoperatively and postoperatively."
10868019|NCT00400764|OG000|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
10868020|NCT00400764|OG001|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868021|NCT00400764|OG002|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
10868022|NCT00400764|OG000|Outcome|Phase Ib Dulanermin|Participants received 4.0 mg/kg/day or 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868023|NCT00400764|OG001|Outcome|Phase II Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants may also have received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868024|NCT00400764|EG000|Reported Event|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868025|NCT00400764|EG001|Reported Event|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868026|NCT00400764|EG002|Reported Event|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
10868027|NCT00400764|EG003|Reported Event|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
10868028|NCT00400764|EG004|Reported Event|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
10868029|NCT00400803|BG000|Baseline|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
10868030|NCT00400803|FG000|Participant Flow|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
10868031|NCT00400803|OG000|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
10868032|NCT00400803|OG000|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine, Carboplatin and Avastin IV every 14 days.
11223184|NCT02351700|BG002|Baseline|Total|Total of all reporting groups
11336549|NCT03568500|OG000|Outcome|Schizophrenia|Participants had a confirmed clinical diagnosis of schizophrenia (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.
10868033|NCT00400803|OG001|Outcome|Partial Response|At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.
10868034|NCT00400803|OG002|Outcome|Stable Disease|Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.
10868035|NCT00400803|OG003|Outcome|Progressive Disease|At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
10868036|NCT00400803|EG000|Reported Event|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
10868037|NCT00400829|BG000|Baseline|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
10868038|NCT00400829|FG000|Participant Flow|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
10868039|NCT00400829|OG000|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
10868040|NCT00400829|EG000|Reported Event|Arm I|"Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
10868041|NCT00400881|BG000|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
10868042|NCT00400881|BG001|Baseline|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
10868043|NCT00400881|BG002|Baseline|Total|Total of all reporting groups
10868044|NCT00400881|FG000|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
10868045|NCT00400881|FG001|Participant Flow|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
10868046|NCT00400881|OG000|Outcome|CPAP|Continuous Positive Airway Pressure
10868047|NCT00400881|OG001|Outcome|ATC (ATComp)|Automatic Tube Compensation
10868048|NCT00400881|OG001|Outcome|ATC (AT Comp)|Automatic Tube Compensation
10868049|NCT00400881|EG000|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
10868050|NCT00400881|EG001|Reported Event|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
10868051|NCT00400985|BG000|Baseline|Group 1|
10868052|NCT00400985|FG000|Participant Flow|All Patients|All study participants received the same treatment
10868053|NCT00400985|OG000|Outcome|All Patients|All patients received the same treatment
10868054|NCT00400985|EG000|Reported Event|Group 1|
10868055|NCT00401102|BG000|Baseline|Group 1|All participants recieved Interpersonal psychotherapy
10868056|NCT00401102|FG000|Participant Flow|Group 1|All participants recieved Interpersonal psychotherapy
10868057|NCT00401102|OG000|Outcome|Group 1|All participants recieved Interpersonal psychotherapy
10868058|NCT00401102|EG000|Reported Event|Group 1|All participants recieved Interpersonal psychotherapy
10868059|NCT00401193|BG000|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10868060|NCT00401193|BG001|Baseline|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
10868061|NCT00401193|BG002|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10868062|NCT00401193|BG003|Baseline|Total|Total of all reporting groups
10868063|NCT00401193|FG000|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10868064|NCT00401193|FG001|Participant Flow|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
10868065|NCT00401193|FG002|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10868066|NCT00401193|OG000|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10868067|NCT00401193|OG001|Outcome|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
10868068|NCT00401193|OG002|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10868069|NCT00401193|OG001|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10868070|NCT00401193|EG000|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10868071|NCT00401193|EG001|Reported Event|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
10868072|NCT00401193|EG002|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
10868073|NCT00401245|BG000|Baseline|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868074|NCT00401245|BG001|Baseline|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868075|NCT00401245|BG002|Baseline|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868076|NCT00401245|BG003|Baseline|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868077|NCT00401245|BG004|Baseline|Total|Total of all reporting groups
10868078|NCT00401245|FG000|Participant Flow|DVS 25 mg, Then 100 mg|Desvenlafaxine succinate (DVS) 25 milligram (mg) tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week open label (OL) phase.
10868079|NCT00401245|FG001|Participant Flow|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868080|NCT00401245|FG002|Participant Flow|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868081|NCT00401245|FG003|Participant Flow|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868082|NCT00401245|FG004|Participant Flow|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally every other day (QOD) alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
10868083|NCT00401245|FG005|Participant Flow|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
10868084|NCT00401245|FG006|Participant Flow|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
10868085|NCT00401245|FG007|Participant Flow|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
10868086|NCT00401245|OG000|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868087|NCT00401245|OG001|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868088|NCT00401245|OG002|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868089|NCT00401245|OG003|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
10868090|NCT00401245|OG000|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
10868091|NCT00401245|OG001|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
10868092|NCT00401245|OG002|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
10868093|NCT00401245|OG003|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
10868094|NCT00401245|OG000|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
10868095|NCT00401245|EG000|Reported Event|DVS 25 mg (Titration Phase)|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase).
10868096|NCT00401245|EG001|Reported Event|DVS 25/50 mg (Titration Phase)|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase).
10868097|NCT00401245|EG002|Reported Event|DVS 50 mg (Titration Phase)|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase).
10868098|NCT00401245|EG003|Reported Event|DVS 100 mg (Titration Phase)|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase).
10868099|NCT00401245|EG004|Reported Event|DVS 100 mg (OL Phase)|After 1 week of double blind titration phase, DVS 100 mg tablet taken orally daily for 15 weeks.
10868100|NCT00401245|EG005|Reported Event|DVS 50 mg QOD (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
10868101|NCT00401245|EG006|Reported Event|DVS 50/25 mg (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
10868102|NCT00401245|EG007|Reported Event|DVS 50 mg/Placebo (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
10868103|NCT00401245|EG008|Reported Event|Placebo (Tapering Phase)|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
10868104|NCT00401258|BG000|Baseline|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
10868105|NCT00401258|FG000|Participant Flow|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
10868106|NCT00401258|OG000|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
10868107|NCT00401258|EG000|Reported Event|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
10868108|NCT00401375|BG000|Baseline|MNTX 12 mg|Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868109|NCT00401375|BG001|Baseline|MNTX 24 mg|Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868110|NCT00401375|BG002|Baseline|Placebo|Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868111|NCT00401375|BG003|Baseline|Total|Total of all reporting groups
10868112|NCT00401375|FG000|Participant Flow|MNTX 12 mg|Participants received methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868113|NCT00401375|FG001|Participant Flow|MNTX 24 mg|Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868114|NCT00401375|FG002|Participant Flow|Placebo|Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868115|NCT00401375|OG000|Outcome|MNTX 12 mg|Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868116|NCT00401375|OG001|Outcome|MNTX 24 mg|Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868117|NCT00401375|OG002|Outcome|Placebo|Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868118|NCT00401375|EG000|Reported Event|MNTX 12 mg|Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868119|NCT00401375|EG001|Reported Event|MNTX 24 mg|Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10879175|NCT00455923|BG000|Baseline|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
10868120|NCT00401375|EG002|Reported Event|Placebo|Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
10868121|NCT00401401|BG000|Baseline|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
10868122|NCT00401401|BG001|Baseline|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
10868123|NCT00401401|BG002|Baseline|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
10868124|NCT00401401|BG003|Baseline|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
10868125|NCT00401401|BG004|Baseline|Total|Total of all reporting groups
10868126|NCT00401401|FG000|Participant Flow|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
10868127|NCT00401401|FG001|Participant Flow|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
10868128|NCT00401401|FG002|Participant Flow|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
10868129|NCT00401401|FG003|Participant Flow|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
10868130|NCT00401401|OG000|Outcome|Zalutumumab 4 mg/kg|
10868131|NCT00401401|OG001|Outcome|Zalutumumab 8 mg/kg|
10868132|NCT00401401|OG002|Outcome|Zalutumumab 12 mg/kg|
10868133|NCT00401401|OG003|Outcome|Zalutumumab 16 mg/kg|
10868134|NCT00401401|OG000|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
10868135|NCT00401401|OG001|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
10868136|NCT00401401|OG002|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
10868137|NCT00401401|OG003|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
10868138|NCT00401401|EG000|Reported Event|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
10868139|NCT00401401|EG001|Reported Event|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
10868140|NCT00401401|EG002|Reported Event|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
10868141|NCT00401401|EG003|Reported Event|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
10868142|NCT00401414|BG000|Baseline|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
10868143|NCT00401414|BG001|Baseline|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
10868144|NCT00401414|BG002|Baseline|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
10868145|NCT00401414|BG003|Baseline|Total|Total of all reporting groups
10868146|NCT00401414|FG000|Participant Flow|Dosing Algorithm A|"Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
10868147|NCT00401414|FG001|Participant Flow|Dosing Algorithm B|Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
10868148|NCT00401414|FG002|Participant Flow|Dosing Algorithm C|Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data. Simulations using Algorithm C were repeated using the clinical endpoints described above to derive the optimal starting warfarin doses and titration scheme that was tested prospectively in subsequent patients enrolled in the CROWN study.
10868149|NCT00401414|OG000|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
10868150|NCT00401414|OG001|Outcome|Dosing Algorithm B|
10868151|NCT00401414|OG002|Outcome|Dosing Algorithm C|
10868152|NCT00401414|OG001|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
10868153|NCT00401414|OG002|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
10868154|NCT00401414|EG000|Reported Event|Dosing Algorithm A|
10868155|NCT00401414|EG001|Reported Event|Dosing Algorithm B|
10868156|NCT00401414|EG002|Reported Event|Dosing Algorithm C|
10868157|NCT00401518|BG000|Baseline|Non-randomized ACADIA®|Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
10868158|NCT00401518|BG001|Baseline|Randomized ACADIA®|Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
10868159|NCT00401518|BG002|Baseline|Randomized Instrumented PLF|Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
10868160|NCT00401518|BG003|Baseline|Total|Total of all reporting groups
10868161|NCT00401518|FG000|Participant Flow|Non-randomized ACADIA®|Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
10868162|NCT00401518|FG001|Participant Flow|Randomized ACADIA®|Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
10868163|NCT00401518|FG002|Participant Flow|Randomized Instrumented PLF|Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
10868164|NCT00401518|OG000|Outcome|Non-randomized ACADIA®|Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
10868165|NCT00401518|OG001|Outcome|Randomized ACADIA®|Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
10868166|NCT00401518|OG002|Outcome|Randomized Instrumented PLF|Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
10868167|NCT00401518|EG000|Reported Event|Non-randomized ACADIA®|Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
10868168|NCT00401518|EG001|Reported Event|Randomized ACADIA®|Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis
10868169|NCT00401518|EG002|Reported Event|Randomized Instrumented PLF|Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
10868170|NCT00401531|BG000|Baseline|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
10868171|NCT00401531|BG001|Baseline|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
10868172|NCT00401531|BG002|Baseline|Total|Total of all reporting groups
10868173|NCT00401531|FG000|Participant Flow|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
10868174|NCT00401531|FG001|Participant Flow|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
10868175|NCT00401531|OG000|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
10868176|NCT00401531|OG001|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
10868177|NCT00401531|EG000|Reported Event|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
10868178|NCT00401531|EG001|Reported Event|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
10868179|NCT00401544|BG000|Baseline|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868180|NCT00401544|BG001|Baseline|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868181|NCT00401544|BG002|Baseline|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868182|NCT00401544|BG003|Baseline|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868183|NCT00401544|BG004|Baseline|Total|Total of all reporting groups
10868184|NCT00401544|FG000|Participant Flow|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868185|NCT00401544|FG001|Participant Flow|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868186|NCT00401544|FG002|Participant Flow|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868187|NCT00401544|FG003|Participant Flow|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868188|NCT00401544|OG000|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868189|NCT00401544|OG001|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868190|NCT00401544|OG000|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868191|NCT00401544|OG001|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868192|NCT00401544|OG000|Outcome|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868193|NCT00401544|OG001|Outcome|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868194|NCT00401544|OG002|Outcome|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868195|NCT00401544|OG003|Outcome|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868196|NCT00401544|OG000|Outcome|Combined Darbepoetin Alfa 300|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868197|NCT00401544|EG000|Reported Event|Darbepoetin Alfa 300 µg (Without IV Iron)|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868198|NCT00401544|EG001|Reported Event|Darbepoetin Alfa 300 µg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868199|NCT00401544|EG002|Reported Event|Darbepoetin Alfa 500 µg (Without Iron)|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868200|NCT00401544|EG003|Reported Event|Darbepoetin Alfa 500 µg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
10868201|NCT00401622|BG000|Baseline|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
10868202|NCT00401622|BG001|Baseline|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
10868203|NCT00401622|BG002|Baseline|Total|Total of all reporting groups
10868204|NCT00401622|FG000|Participant Flow|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
10868205|NCT00401622|FG001|Participant Flow|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
10868206|NCT00401622|OG000|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
10868207|NCT00401622|OG001|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
10868208|NCT00401622|EG000|Reported Event|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
10868209|NCT00401622|EG001|Reported Event|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
10868210|NCT00401726|BG000|Baseline|Venlafaxine Extended Release (ER)|75-225 mg per day
10868211|NCT00401726|BG001|Baseline|Venlafaxine Extended Release (ER) Plus Dialogues|"Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."
10868212|NCT00401726|BG002|Baseline|Total|Total of all reporting groups
10868213|NCT00401726|FG000|Participant Flow|Venlafaxine Extended Release (ER)|75-225 mg per day
10868214|NCT00401726|FG001|Participant Flow|Venlafaxine Extended Release (ER) Plus Dialogues|"Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."
10868215|NCT00401726|OG000|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
10868216|NCT00401726|OG001|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|"Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."
10868217|NCT00401726|EG000|Reported Event|Venlafaxine Extended Release (ER)|75-225 mg per day
10868218|NCT00401726|EG001|Reported Event|Venlafaxine Extended Release (ER) Plus Dialogues|"Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."
10868219|NCT00401752|BG000|Baseline|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
10868220|NCT00401752|BG001|Baseline|Ranitidine|ranitidine 150 mg capsule bid oral administration
10868221|NCT00401752|BG002|Baseline|Total|Total of all reporting groups
10868222|NCT00401752|FG000|Participant Flow|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
10868223|NCT00401752|FG001|Participant Flow|Ranitidine|ranitidine 150 mg capsule bid oral administration
10868224|NCT00401752|OG000|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
10868225|NCT00401752|OG001|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
10868226|NCT00401752|EG000|Reported Event|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
10868227|NCT00401752|EG001|Reported Event|Ranitidine|ranitidine 150 mg capsule bid oral administration
10868228|NCT00401778|BG000|Baseline|Control|No everolimus taken.
10868229|NCT00401778|BG001|Baseline|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
10868230|NCT00401778|BG002|Baseline|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
10868231|NCT00401778|BG003|Baseline|Total|Total of all reporting groups
10868232|NCT00401778|FG000|Participant Flow|Control|No everolimus taken.
10868233|NCT00401778|FG001|Participant Flow|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
10868234|NCT00401778|FG002|Participant Flow|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
10868235|NCT00401778|OG000|Outcome|Control|No everolimus taken.
10868236|NCT00401778|OG001|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
10868237|NCT00401778|OG002|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
10868238|NCT00401778|OG001|Outcome|Everolimus 5 or 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
10868239|NCT00401778|EG000|Reported Event|Control|No everolimus taken.
10868240|NCT00401778|EG001|Reported Event|Everolimus 5 & 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
10868241|NCT00401817|BG000|Baseline|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
10868242|NCT00401817|FG000|Participant Flow|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
10868243|NCT00401817|OG000|Outcome|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
10868244|NCT00401817|OG000|Outcome|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles~Rituximab: Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.~The dose to be administered is:~Rituximab: 375 mg/m2~CHOP: Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7"
10868245|NCT00401817|EG000|Reported Event|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
10868246|NCT00401830|BG000|Baseline|Placebo|Matching placebo tablet (administered twice daily)
10868247|NCT00401830|BG001|Baseline|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
10868248|NCT00401830|BG002|Baseline|Total|Total of all reporting groups
10868249|NCT00401830|FG000|Participant Flow|Placebo|Matching placebo tablet (administered twice daily)
10868250|NCT00401830|FG001|Participant Flow|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
10868251|NCT00401830|OG000|Outcome|Placebo|Matching placebo tablet (administered twice daily)
10868252|NCT00401830|OG001|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
10868253|NCT00401830|EG000|Reported Event|Placebo|Matching placebo tablet (administered twice daily)
10868254|NCT00401830|EG001|Reported Event|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
10868255|NCT00401843|BG000|Baseline|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
10868256|NCT00401843|BG001|Baseline|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
10868257|NCT00401843|BG002|Baseline|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
10868258|NCT00401843|BG003|Baseline|Total|Total of all reporting groups
10868259|NCT00401843|FG000|Participant Flow|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
10868260|NCT00401843|FG001|Participant Flow|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
10868261|NCT00401843|FG002|Participant Flow|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
10868262|NCT00401843|OG000|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
10868263|NCT00401843|OG001|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
10868264|NCT00401843|OG000|Outcome|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
10868265|NCT00401843|OG001|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
11336550|NCT03568500|OG001|Outcome|Schizoaffective Disorder|Participants had a confirmed clinical diagnosis of schizoaffective disorder (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.
10846169|NCT00273910|BG003|Baseline|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
10846170|NCT00273910|BG004|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846171|NCT00273910|BG005|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
10846172|NCT00273910|BG006|Baseline|Total|Total of all reporting groups
10846173|NCT00273910|FG000|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10868266|NCT00401843|OG002|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
10868267|NCT00401843|EG000|Reported Event|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
10868268|NCT00401843|EG001|Reported Event|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
10868269|NCT00401843|EG002|Reported Event|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
10868270|NCT00401882|BG000|Baseline|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
10868271|NCT00401882|BG001|Baseline|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
10868272|NCT00401882|BG002|Baseline|Total|Total of all reporting groups
10868273|NCT00401882|FG000|Participant Flow|Additional Doses of Epinephrine|Epinephrine: additional doses Epinephrine (1 mg) IV given as part of standard of care in cardiac arrest
10868274|NCT00401882|FG001|Participant Flow|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional doses of epinephrine
10868275|NCT00401882|OG000|Outcome|Additional Doses of Epinephrine|Epinephrine: Additional doses of epinephrine (1 mg IV) given as part of standard of care during cardiac arrest
11348759|NCT04136444|OG001|Outcome|Cohort B (PKS)|Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
10868276|NCT00401882|OG001|Outcome|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol 5 mg IV (up to 2 times) instead of additional epinephrine doses
10868277|NCT00401882|OG000|Outcome|Additional Epinephrine Doses|"Additional doses of Epinephrine (1 mg) given as part of standard of care during cardiac arrest~Epinephrine: Epinephrine (1 mg) IV additional doses"
10868278|NCT00401882|OG001|Outcome|Metoprolol Instead of Additional Epinephrine Doses|"IV metoprolol 5 mg. (up to 2 times only) during cardiac arrest will be given instead of additional Epinephrine doses~Metoprolol: Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses"
10868279|NCT00401882|OG000|Outcome|Additional Doses of Epinephrine|Epinephrine: Additional doses of epinephrine IV (1 mg) given as part of standard of care in cardiac arrest
10868280|NCT00401882|OG001|Outcome|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol: Metoprolol 5mg IV (up to two times only) instead of additional epinephrine doses
10868281|NCT00401882|OG000|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
10868282|NCT00401882|OG001|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
10868283|NCT00401882|EG000|Reported Event|Additional Doses of Epinephrine|Epinephrine: Additional doses epinephrine (1 mg IV) as part of standard of care during cardiac arrest
10868284|NCT00401882|EG001|Reported Event|Metoprolol Instead of Additional Doses of Epinephrine|Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional epinephrine doses
10868285|NCT00401960|BG000|Baseline|Adjunctive Daptomycin Group|please see study description for study enrollment
10868286|NCT00401960|BG001|Baseline|Standard of Care Group|as per study description
10868287|NCT00401960|BG002|Baseline|Total|Total of all reporting groups
10868288|NCT00401960|FG000|Participant Flow|Adjunctive Daptomycin Group|please see study description for study enrollment
10868289|NCT00401960|FG001|Participant Flow|Standard of Care Group|as per study description
10868290|NCT00401960|OG000|Outcome|Adjunctive Daptomycin Group|please see study description for study enrollment
10868291|NCT00401960|OG001|Outcome|Standard of Care Group|as per study description
10868292|NCT00401960|OG000|Outcome|Daptomycin Adjunctive Group|"Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving~Daptomycin: daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis"
10868293|NCT00401960|OG001|Outcome|Standard of Care|Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician
10868294|NCT00401960|EG000|Reported Event|Adjunctive Daptomycin Group|please see study description for study enrollment
10868295|NCT00401960|EG001|Reported Event|Standard of Care Group|as per study description
10868296|NCT00401973|BG000|Baseline|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
10868297|NCT00401973|BG001|Baseline|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
10868298|NCT00401973|BG002|Baseline|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
10868299|NCT00401973|BG003|Baseline|Total|Total of all reporting groups
10868300|NCT00401973|FG000|Participant Flow|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
10868301|NCT00401973|FG001|Participant Flow|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
10868302|NCT00401973|FG002|Participant Flow|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
10868303|NCT00401973|OG000|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
10868304|NCT00401973|OG001|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
10868305|NCT00401973|OG002|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
10868306|NCT00401973|OG000|Outcome|2 Weeks|"Combined treatment groups:~olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].~Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].~Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
10868307|NCT00401973|OG001|Outcome|22 Weeks|"Combined treatment groups:~olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].~Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].~Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
10868308|NCT00401973|EG000|Reported Event|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
10868309|NCT00401973|EG001|Reported Event|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
10868310|NCT00401973|EG002|Reported Event|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
10868311|NCT00401986|BG000|Baseline|Alair Group|Baseline Demographics are based on data collected at the time of entry into the PREDECESSOR STUDY (NCT00214539).
10868312|NCT00401986|FG000|Participant Flow|Alair Group|A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.
10868313|NCT00401986|OG000|Outcome|Alair Group|"A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.~A total of 145 adverse events have been reported by the 14 subjects enrolled in the present study over Year 2 through 5. One hundred and three adverse events (71%) were respiratory-related.~The number of subjects reporting respiratory-related adverse events each year was consistent. Reporting were 11/14 subjects (78.6%) in Year 2, 12/14 subjects (85.7%) in Year 3, 10/12 subjects (83.3%) in Year 4, and 12/12 subjects (100%) in Year 5 reported respiratory adverse events."
10868314|NCT00401986|OG000|Outcome|Alair Group|A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.
10868315|NCT00401986|OG000|Outcome|Alair Group|"A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.~."
10868316|NCT00401986|EG000|Reported Event|Year 2|Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
10846174|NCT00273910|FG001|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
10846175|NCT00273910|FG002|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846176|NCT00273910|FG003|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
10846177|NCT00273910|FG004|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846178|NCT00273910|FG005|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
10846179|NCT00273910|OG000|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846180|NCT00273910|OG001|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
10846181|NCT00273910|OG002|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846182|NCT00273910|OG003|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
10846183|NCT00273910|OG004|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846184|NCT00273910|OG005|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
10846185|NCT00273910|EG000|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846186|NCT00273910|EG001|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
10846187|NCT00273910|EG002|Reported Event|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846188|NCT00273910|EG003|Reported Event|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
10846189|NCT00273910|EG004|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
10846190|NCT00273910|EG005|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
10846191|NCT00274261|BG000|Baseline|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
10846192|NCT00274261|BG001|Baseline|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
10846193|NCT00274261|BG002|Baseline|Total|Total of all reporting groups
10846194|NCT00274261|FG000|Participant Flow|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
10846195|NCT00274261|FG001|Participant Flow|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
10846196|NCT00274261|OG000|Outcome|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
10846197|NCT00274261|OG001|Outcome|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
10846198|NCT00274261|OG000|Outcome|C31G Vaginal Gel|"C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel~C31G: The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study."
10846199|NCT00274261|OG001|Outcome|Conceptrol® Vaginal Gel|"Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.~nonoxynol-9 (N-9): The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study."
10846200|NCT00274261|EG000|Reported Event|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
10846201|NCT00274261|EG001|Reported Event|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
10868317|NCT00401986|EG001|Reported Event|Year 3|Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
10868318|NCT00401986|EG002|Reported Event|Year 4|Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
10868319|NCT00401986|EG003|Reported Event|Year 5|Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
10868320|NCT00402025|BG000|Baseline|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868321|NCT00402025|BG001|Baseline|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868322|NCT00402025|BG002|Baseline|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868323|NCT00402025|BG003|Baseline|Total|Total of all reporting groups
10868324|NCT00402025|FG000|Participant Flow|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴plaque-forming units (PFU)/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868325|NCT00402025|FG001|Participant Flow|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868326|NCT00402025|FG002|Participant Flow|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868327|NCT00402025|OG000|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868328|NCT00402025|OG001|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868329|NCT00402025|OG002|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868330|NCT00402025|EG000|Reported Event|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868331|NCT00402025|EG001|Reported Event|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868332|NCT00402025|EG002|Reported Event|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
10868333|NCT00402051|BG000|Baseline|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
10868334|NCT00402051|BG001|Baseline|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
10868335|NCT00402051|BG002|Baseline|Total|Total of all reporting groups
10868336|NCT00402051|FG000|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
10868337|NCT00402051|FG001|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
10868338|NCT00402051|OG000|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
10868339|NCT00402051|OG001|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
11348760|NCT04136444|OG000|Outcome|Cohort A Single Dose (SS)|Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 as oral tablets. Participants formed the Safety Set (SS).
10868340|NCT00402051|EG000|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
10868341|NCT00402051|EG001|Reported Event|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
10868342|NCT00402103|BG000|Baseline|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
10868343|NCT00402103|BG001|Baseline|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
10868344|NCT00402103|BG002|Baseline|Total|Total of all reporting groups
10868345|NCT00402103|FG000|Participant Flow|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
10868346|NCT00402103|FG001|Participant Flow|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
10868347|NCT00402103|OG000|Outcome|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
10868348|NCT00402103|OG001|Outcome|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
10868349|NCT00402103|OG002|Outcome|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
10868350|NCT00402103|OG000|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
10868351|NCT00402103|OG001|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
10868352|NCT00402103|EG000|Reported Event|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
10868353|NCT00402103|EG001|Reported Event|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
10868354|NCT00402103|EG002|Reported Event|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
10868355|NCT00402116|BG000|Baseline|Phase 1- Cohort 1 (250 mg Enzastaurin)|Participants who received 250 mg enzastaurin in Phase I with 75 mg/m^2 temozolomide and radiotherapy.
10868356|NCT00402116|BG001|Baseline|Phase 1 Cohort 2 (500 mg Enzastaurin )|Participants who received 500 mg enzastaurin in Phase I with 75 mg/m^2 temozolomide and radiotherapy.
10868357|NCT00402116|BG002|Baseline|Phase 2|Participants who received 250 mg enzastaurin in Phase II with 75 mg/m^2 temozolomide and radiotherapy.
10868358|NCT00402116|BG003|Baseline|Total|Total of all reporting groups
10868359|NCT00402116|FG000|Participant Flow|Phase 1- Cohort 1 (250 mg Enzastaurin)|Phase 1--Determination of the maximum tolerated dose (MTD) of enzastaurin in participants with newly diagnosed GBM or GS receiving a 250 mg dose - Cohort 1.
10868360|NCT00402116|FG001|Participant Flow|Phase 1 Cohort 2 (500 mg Enzastaurin)|Phase 1--Determination of the maximum tolerated dose (MTD) of enzastaurin in participants with newly diagnosed GBM or GS receiving a 500 mg dose - Cohort 2.
10868361|NCT00402116|FG002|Participant Flow|Phase 2|Phase 1 established dose (250 mg), daily for 6 weeks, then twelve 28-day cycles.
10868362|NCT00402116|OG000|Outcome|Phase 1 Participants|Participants who received escalating doses of 250 mg and 500 mg enzastaurin in Phase 1 with 75 mg/m^2 temozolomide and radiotherapy.
10868363|NCT00402116|OG000|Outcome|250 mg Enzastaurin Phases 1 and 2 Combined|Phase 2 participants combined with Phase 1 - Cohort 1 participants who also received 250 mg enzastaurin.
10868364|NCT00402116|OG000|Outcome|Phase 1- Cohort 1 (250 mg Enzastaurin)|Summaries of SAEs and all other non-serious AEs for Phase 1- Cohort 1 (250 mg Enzastaurin) participants
10868365|NCT00402116|OG001|Outcome|Phase 1 Cohort 2 (500 mg Enzastaurin )|Summaries of SAEs and all other non-serious AEs for Phase 1- Cohort 2 (500 mg Enzastaurin) participants
10868366|NCT00402116|OG000|Outcome|250 mg Enzastaurin Phases 1 and 2 Combined|Participants with valid IHC scores from combined Phase 1 and 2 populations 250 mg enzastaurin.
10868367|NCT00402116|OG000|Outcome|250 mg Enzastaurin Phases 1 and 2 Combined|Efficacy analysis in Phase 1 was not conducted. Instead, participants who took 250 mg enzastaurin in Phase 1 were pooled with Phase 2 participants. Overall survival (OS) and progression-free survival (PFS) for this combined group are presented in other outcome measures (2 and 8, respectively) in this result record.
10868368|NCT00402116|OG000|Outcome|Phase 2 - 250 mg Enzastaurin|Summaries of SAEs and all other non-serious AEs for Phase 2 - 250 mg Enzastaurin participants are located in the Reported Adverse Event Module.
10868369|NCT00402116|OG000|Outcome|Phase 2 - 250 mg|Participants who underwent magnetic resonance imaging (MRI) for clinical evaluation and had a baseline assessment.
10868370|NCT00402116|OG000|Outcome|250 mg Enzastaurin Phases 1 and 2 Combined|All treated participants in the 250 mg enzastaurin cohort from Phases 1 and 2 combined
10868371|NCT00402116|OG000|Outcome|250 mg Enzastaurin Phases 1 and 2 Combined|All treated participants in the 250 mg enzastaurin cohort from phases 1 and 2 combined.
10868372|NCT00402116|OG000|Outcome|Enzastaurin 250 mg Phases 1 and 2 Combined-Fatigue|All treated participants who received at least 1 dose of study drug in the 250 mg enzastaurin cohort from Phases 1 and 2 combined and provided MDASI-BT data from at least 1 visit. Question: Your fatigue (tiredness) at its WORST?
10868373|NCT00402116|OG001|Outcome|Enzastaurin 250 mg Phase 1 and 2 Combined-Memory|All treated participants who received at least 1 dose of study drug in the 250 mg enzastaurin cohort from Phases 1 and 2 combined and provided MDASI-BT data from at least 1 visit (N = 65). Question: Your problem with remembering things at its WORST?
10868374|NCT00402116|OG002|Outcome|Enzastaurin 250 mg Phase 1 and 2 Combined-Appetite|All treated participants who received at least 1 dose of study drug in the 250 mg enzastaurin cohort from Phases 1 and 2 combined and provided MDASI-BT data from at least 1 visit. Question: Your problem with lack of appetite at its WORST?
10868375|NCT00402116|OG003|Outcome|Enzastaurin 250 mg Phase 1 and 2 Combined-Concentration|All treated participants who received at least 1 dose of study drug in the 250 mg enzastaurin cohort from Phases 1 and 2 combined and provided MDASI-BT data from at least 1 visit. Question: Your difficulty concentrating at its WORST?
10868376|NCT00402116|OG000|Outcome|Enzastaurin 250 mg|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 1 Day 22 (enzastaurin alone) following enzastaurin 250 mg oral (po) daily QD) for Phase 1 Cohort 1.
10868377|NCT00402116|OG001|Outcome|Enzastaurin 250 mg + Temozolomide|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 2 Day 5 (enzastaurin with temozolomide) following enzastaurin 250 mg oral (po) daily QD) for Phase 1 Cohort 1.
10868378|NCT00402116|OG002|Outcome|Enzastaurin 500 mg|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 2 Day 5 (enzastaurin alone) following enzastaurin 500 mg oral (po) daily QD) for Phase 1 Cohort 2.
10868379|NCT00402116|OG003|Outcome|Enzastaurin 500 mg + Temozolomide|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 2 Day 5 (enzastaurin with temozolomide) following enzastaurin 500 mg oral (po) daily QD) for Phase 1 Cohort 2.
10868380|NCT00402116|OG000|Outcome|Enzastaurin 250 mg Phase 1|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 1 Day 22 (enzastaurin alone) following enzastaurin 250 mg orally (po) daily (QID) for Phase 1 Cohort 1.
10868381|NCT00402116|OG001|Outcome|Enzastaurin 250 mg + Temozolomide|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 2 Day 5 (enzastaurin with temozolomide) following enzastaurin 250 mg po QID for Phase 1 Cohort 1.
10868382|NCT00402116|OG002|Outcome|Enzastaurin 250 mg Phase 2|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 1 Day 22 (enzastaurin alone) following enzastaurin 500 mg oral po QID for Phase 1 Cohort 2
10868383|NCT00402116|OG003|Outcome|Enzastaurin 500 mg|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 2 Day 5 (enzastaurin with temozolomide) following enzastaurin 500 mg oral po QID for Phase 1 Cohort 2.
10868384|NCT00402116|OG004|Outcome|Enzastaurin 500 mg + Temozolomide|Enzastaurin, LY326020 and total analyte (enzastaurin + LY326020) on Cycle 1 Day 22 (enzastaurin alone) following enzastaurin 250 mg oral po QID for Phase 2.
10868385|NCT00402116|EG000|Reported Event|Phase 1- Cohort 1 (250 mg Enzastaurin)|Phase 1--Determination of the maximum tolerated dose (MTD) of enzastaurin in participants with newly diagnosed GBM or GS receiving a 250 mg dose.
10868386|NCT00402116|EG001|Reported Event|Phase 1 Cohort 2 (500 mg Enzastaurin)|Phase 1--Determination of the maximum tolerated dose (MTD) of enzastaurin in participants with newly diagnosed GBM or GS receiving a 500 mg dose.
10868387|NCT00402116|EG002|Reported Event|Phase 2 - 250 mg Enzastaurin|Participants received 250 mg enzastaurin daily for 6 weeks, then twelve 28-day cycles.
10868388|NCT00402168|BG000|Baseline|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
10868389|NCT00402168|BG001|Baseline|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
10868390|NCT00402168|BG002|Baseline|Total|Total of all reporting groups
10868391|NCT00402168|FG000|Participant Flow|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
10868392|NCT00402168|FG001|Participant Flow|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
10868393|NCT00402168|OG000|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg was given IV every 28 days.
10868394|NCT00402168|OG001|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
10868395|NCT00402168|OG000|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
10868396|NCT00402168|OG001|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
10868397|NCT00402168|OG000|Outcome|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
10868398|NCT00402168|OG001|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm by Year 3.
10868399|NCT00402168|OG000|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg given IV every 28 days.
10868400|NCT00402168|OG000|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants who had been randomized to CNI were allowed to switch to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
10868401|NCT00402168|OG000|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
10868402|NCT00402168|EG000|Reported Event|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days. Adverse events reported for participants who were treated with only Belatacept throughout the study.
11348761|NCT04136444|OG001|Outcome|Cohort B Single Dose (SS)|Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 as oral tablets. Participants formed the SS.
10868403|NCT00402168|EG001|Reported Event|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to Belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the Belatacept arm. Adverse events reported for participants who were treated with only CNI for the entire study and those who were later switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period prior to their first Belatacept dose.
10868404|NCT00402168|EG002|Reported Event|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to Belatacept. For those switching to Belatacept, the CNI dose was tapered and discontinued, after which they received Belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received Belatacept 5 mg/kg IV every 28 days. Adverse events reported for participants who were switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period on or after their first Belatacept dose.
10868405|NCT00402194|BG000|Baseline|Treatment|Treatment with 100mg of losartan daily or placebo. Outcomes measured before and after 3 months of treatment.
10868406|NCT00402194|BG001|Baseline|Placebo|Placebo
10868407|NCT00402194|BG002|Baseline|Total|Total of all reporting groups
10868408|NCT00402194|FG000|Participant Flow|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
10868409|NCT00402194|FG001|Participant Flow|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
10868410|NCT00402194|OG000|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
10868411|NCT00402194|OG001|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
10868412|NCT00402194|EG000|Reported Event|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
10868413|NCT00402194|EG001|Reported Event|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
10868414|NCT00402233|BG000|Baseline|Placebo|matching tablet
10868415|NCT00402233|BG001|Baseline|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868416|NCT00402233|BG002|Baseline|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868417|NCT00402233|BG003|Baseline|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868418|NCT00402233|BG004|Baseline|Total|Total of all reporting groups
10868419|NCT00402233|FG000|Participant Flow|Placebo|matching tablet
10868420|NCT00402233|FG001|Participant Flow|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868421|NCT00402233|FG002|Participant Flow|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868422|NCT00402233|FG003|Participant Flow|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868423|NCT00402233|OG000|Outcome|Placebo|matching tablet
10868424|NCT00402233|OG001|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868425|NCT00402233|OG002|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868426|NCT00402233|OG003|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868427|NCT00402233|EG000|Reported Event|Placebo|matching tablet
10868428|NCT00402233|EG001|Reported Event|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868429|NCT00402233|EG002|Reported Event|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868430|NCT00402233|EG003|Reported Event|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
10868431|NCT00402246|BG000|Baseline|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
10868432|NCT00402246|BG001|Baseline|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
10868433|NCT00402246|BG002|Baseline|Total|Total of all reporting groups
10868434|NCT00402246|FG000|Participant Flow|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
10868435|NCT00402246|FG001|Participant Flow|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
10868436|NCT00402246|OG000|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
11348762|NCT04136444|OG002|Outcome|Cohort A Multiple Dose (SS)|Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
10868437|NCT00402246|OG001|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
10868438|NCT00402246|OG000|Outcome|Patients With a Study CRT-D Device|Patients in either the Remote Arm or the In-office Arm who were implanted with a study CRT-D Device, as these are the only devices that have Left Ventricular leads
10868439|NCT00402246|OG000|Outcome|Clinicians|Clinicians who responded to the survey
10868440|NCT00402246|OG000|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
10868441|NCT00402246|EG000|Reported Event|Enrolled Subjects|All enrolled subjects in the study
10868442|NCT00402285|BG000|Baseline|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
10868443|NCT00402285|BG001|Baseline|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
10868444|NCT00402285|BG002|Baseline|Placebo|men took placebo for lycopene & placebo for fish oil.
10868445|NCT00402285|BG003|Baseline|Total|Total of all reporting groups
10868446|NCT00402285|FG000|Participant Flow|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
10868447|NCT00402285|FG001|Participant Flow|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
10868448|NCT00402285|FG002|Participant Flow|Placebo|men took placebo for lycopene & placebo for fish oil.
10868449|NCT00402285|OG000|Outcome|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
10868450|NCT00402285|OG001|Outcome|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
10868451|NCT00402285|OG002|Outcome|Placebo|men took placebo for lycopene & placebo for fish oil.
10868452|NCT00402285|EG000|Reported Event|All Participants|
10868453|NCT00402298|BG000|Baseline|Full Dose (125 mg)|"Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.~3,4-methylenedioxymethemphetmaine (MDMA_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session."
10868454|NCT00402298|BG001|Baseline|Active Comparator (25 mg)|"25 and 12.5 mg MDMA~3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions."
10868455|NCT00402298|BG002|Baseline|Total|Total of all reporting groups
10868456|NCT00402298|FG000|Participant Flow|Full Dose (125 mg)|"Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.~3,4-methylenedioxymethemphetmaine (MDMA_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session."
10868457|NCT00402298|FG001|Participant Flow|Low Dose (25 mg)|"25 and 12.5 mg MDMA~3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions."
10868458|NCT00402298|OG000|Outcome|Full Dose (125 mg)|"Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.~3,4-methylenedioxymethemphetmaine (MDMA_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session."
10868459|NCT00402298|OG001|Outcome|Low Dose (25 mg)|"25 and 12.5 mg MDMA~3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions."
10868460|NCT00402298|EG000|Reported Event|Full Dose (125 mg) MDMA-assisted Therapy|"Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.~3,4-methylenedioxymethemphetmaine (MDMA_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session."
10868461|NCT00402298|EG001|Reported Event|Low Dose (25 mg) MDMA-assisted Therapy|"25 and 12.5 mg MDMA~3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions."
10868462|NCT00402324|BG000|Baseline|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
10868463|NCT00402324|BG001|Baseline|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
10868464|NCT00402324|BG002|Baseline|Total|Total of all reporting groups
10868465|NCT00402324|FG000|Participant Flow|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
10868466|NCT00402324|FG001|Participant Flow|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
10868467|NCT00402324|OG000|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
10868468|NCT00402324|OG001|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
10868469|NCT00402324|EG000|Reported Event|Olanzapine|Olanzapine: 15mg, capsules, PO at Q HS, daily for 1 week followed by 5-20mg, capsules, PO at Q HS daily for 5 weeks (6 weeks total). Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following d ose achieved in Study Period I)
10868470|NCT00402324|EG001|Reported Event|Placebo|Placebo: placebo capsules, PO, at Q HS, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following dose achieved in Study Period I).
10868471|NCT00402337|BG000|Baseline|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
10868472|NCT00402337|BG001|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day. One patient was randomized into the study but did not receive ≥ 1 dose of study drug, thus was not included in the Safety Population.
10868473|NCT00402337|BG002|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
10868474|NCT00402337|BG003|Baseline|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
10868475|NCT00402337|BG004|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
10868476|NCT00402337|BG005|Baseline|Total|Total of all reporting groups
10868477|NCT00402337|FG000|Participant Flow|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
10868478|NCT00402337|FG001|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
10868479|NCT00402337|FG002|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
10868480|NCT00402337|FG003|Participant Flow|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
10868481|NCT00402337|FG004|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
10868482|NCT00402337|OG000|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
10868483|NCT00402337|OG001|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
10868484|NCT00402337|OG002|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
10868485|NCT00402337|OG003|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
10868486|NCT00402337|OG004|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
10868487|NCT00402337|EG000|Reported Event|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
10868488|NCT00402337|EG001|Reported Event|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
10868489|NCT00402337|EG002|Reported Event|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
10868490|NCT00402337|EG003|Reported Event|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
10868491|NCT00402337|EG004|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
10868492|NCT00402363|BG000|Baseline|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
10868493|NCT00402363|BG001|Baseline|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
10868494|NCT00402363|BG002|Baseline|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
10868495|NCT00402363|BG003|Baseline|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
10868496|NCT00402363|BG004|Baseline|Total|Total of all reporting groups
10868497|NCT00402363|FG000|Participant Flow|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
10868498|NCT00402363|FG001|Participant Flow|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
10868499|NCT00402363|FG002|Participant Flow|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
10868500|NCT00402363|FG003|Participant Flow|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
10868501|NCT00402363|OG000|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
10868502|NCT00402363|OG001|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
10868503|NCT00402363|OG000|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
10868504|NCT00402363|OG001|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
10868505|NCT00402363|OG002|Outcome|Combined, Placebo|Participants with both paroxysmal and persistent AF receiving matching placebo
10868506|NCT00402363|OG003|Outcome|Combined, P-OM3|Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
10868507|NCT00402363|OG002|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
10868508|NCT00402363|OG003|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
10868509|NCT00402363|OG000|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
10868510|NCT00402363|OG001|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
10868511|NCT00402363|OG004|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
10868512|NCT00402363|OG005|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
10868513|NCT00402363|EG000|Reported Event|Placebo|Participants receiving matching placebo
10868514|NCT00402363|EG001|Reported Event|Prescription Omega-3 Acid Ethyl Esters|Participants receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
10868515|NCT00402597|BG000|Baseline|Placebo|One placebo tablet twice daily for 6 months.
10868516|NCT00402597|BG001|Baseline|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
10868517|NCT00402597|BG002|Baseline|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
10868518|NCT00402597|BG003|Baseline|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
10868519|NCT00402597|BG004|Baseline|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
10868520|NCT00402597|BG005|Baseline|Total|Total of all reporting groups
10868521|NCT00402597|FG000|Participant Flow|Placebo|One placebo tablet twice daily for 6 months.
10868522|NCT00402597|FG001|Participant Flow|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
10868523|NCT00402597|FG002|Participant Flow|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
10868524|NCT00402597|FG003|Participant Flow|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
10868525|NCT00402597|FG004|Participant Flow|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
10868526|NCT00402597|OG000|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
10868527|NCT00402597|OG001|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
10868528|NCT00402597|OG002|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
10868529|NCT00402597|OG003|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
10868530|NCT00402597|OG004|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
10868531|NCT00402597|EG000|Reported Event|Placebo|One placebo tablet twice daily for 6 months.
10868532|NCT00402597|EG001|Reported Event|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
10868533|NCT00402597|EG002|Reported Event|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
10868534|NCT00402597|EG003|Reported Event|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
10868535|NCT00402597|EG004|Reported Event|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
10868536|NCT00402649|BG000|Baseline|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
10868537|NCT00402649|FG000|Participant Flow|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
10868538|NCT00402649|OG000|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
10868539|NCT00402649|EG000|Reported Event|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
10868540|NCT00402688|BG000|Baseline|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
10868541|NCT00402688|BG001|Baseline|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
10868542|NCT00402688|BG002|Baseline|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
10868543|NCT00402688|BG003|Baseline|Total|Total of all reporting groups
10868544|NCT00402688|FG000|Participant Flow|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
10868545|NCT00402688|FG001|Participant Flow|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
10868546|NCT00402688|FG002|Participant Flow|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
10868547|NCT00402688|OG000|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
10868548|NCT00402688|OG001|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
10868549|NCT00402688|OG002|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
10868550|NCT00402688|EG000|Reported Event|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
10868551|NCT00402688|EG001|Reported Event|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
10868552|NCT00402688|EG002|Reported Event|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
10868553|NCT00402714|BG000|Baseline|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868554|NCT00402714|BG001|Baseline|2 Pent/TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868555|NCT00402714|BG002|Baseline|Total|Total of all reporting groups
10868556|NCT00402714|FG000|Participant Flow|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868557|NCT00402714|FG001|Participant Flow|Pent|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868558|NCT00402714|OG000|Outcome|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868559|NCT00402714|OG001|Outcome|2 Pent/TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868560|NCT00402714|OG000|Outcome|ECP Pento TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868561|NCT00402714|OG001|Outcome|Pento TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868562|NCT00402714|EG000|Reported Event|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868563|NCT00402714|EG001|Reported Event|Pent|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
10868564|NCT00402727|BG000|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
10868565|NCT00402727|BG001|Baseline|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
10868566|NCT00402727|BG002|Baseline|Total|Total of all reporting groups
10868567|NCT00402727|FG000|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
11348763|NCT04136444|OG003|Outcome|Cohort B Multiple Dose (SS)|Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
10868568|NCT00402727|FG001|Participant Flow|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
10868569|NCT00402727|OG000|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
10868570|NCT00402727|OG001|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
10868571|NCT00402727|EG000|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
10868572|NCT00402727|EG001|Reported Event|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
10868573|NCT00402740|BG000|Baseline|Group 1|
10868574|NCT00402740|FG000|Participant Flow|Group 1|
10868575|NCT00402740|OG000|Outcome|Group 1|Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.
10868576|NCT00402740|OG000|Outcome|Xact Stent|The Xact stent success were counted per subject
10868577|NCT00402740|OG001|Outcome|Emboshield Pro Gen 5|Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.
10868578|NCT00402740|OG002|Outcome|Emboshield Gen 3|Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
10868579|NCT00402740|OG000|Outcome|Group 1|
10868580|NCT00402740|EG000|Reported Event|Group 1|
10868581|NCT00402779|BG000|Baseline|Erlotinib|Erlotinib 150 mg PO daily x 12 months
10868582|NCT00402779|BG001|Baseline|Placebo|Placebo PO daily x 12 months
10868583|NCT00402779|BG002|Baseline|Total|Total of all reporting groups
10868584|NCT00402779|FG000|Participant Flow|Erlotinib|Erlotinib 150 mg PO daily x 12 months
10868585|NCT00402779|FG001|Participant Flow|Placebo|Placebo PO daily x 12 months
10868586|NCT00402779|OG000|Outcome|Erlotinib|Erlotinib 150 mg PO daily x 12 months
10868587|NCT00402779|OG001|Outcome|Placebo|Placebo PO daily x 12 months
10868588|NCT00402779|EG000|Reported Event|Erlotinib|Erlotinib 150 mg PO daily x 12 months
10868589|NCT00402779|EG001|Reported Event|Placebo|Placebo PO daily x 12 months
10868590|NCT00402831|BG000|Baseline|Intramuscular ProQuad®|Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
10868591|NCT00402831|BG001|Baseline|Subcutaneous ProQuad®|Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
10868592|NCT00402831|BG002|Baseline|Total|Total of all reporting groups
10868593|NCT00402831|FG000|Participant Flow|Intramuscular ProQuad®|Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
10868594|NCT00402831|FG001|Participant Flow|Subcutaneous ProQuad®|Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
10868595|NCT00402831|OG000|Outcome|Intramuscular ProQuad®|Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
10868596|NCT00402831|OG001|Outcome|Subcutaneous ProQuad®|Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
10868597|NCT00402831|EG000|Reported Event|IM ProQuad® Arm: Dose 1|All participants who received the first dose of ProQuad® via IM injection are included.
10868598|NCT00402831|EG001|Reported Event|SC ProQuad® Arm: Dose 1|All participants who received the first dose of ProQuad® via SC injection are included.
10868599|NCT00402831|EG002|Reported Event|IM ProQuad® Arm: Dose 2|All participants who received the second dose of ProQuad® via IM injection are included.
10868600|NCT00402831|EG003|Reported Event|SC ProQuad® Arm: Dose 2|All participants who received the second dose of ProQuad® via SC injection are included.
10868601|NCT00402896|BG000|Baseline|ZD6474|300 mg/day orally for 10 weeks.
10868602|NCT00402896|FG000|Participant Flow|ZD6474|300 mg/day orally for 10 weeks.
10868603|NCT00402896|OG000|Outcome|ZD6474|300 mg/day orally for 10 weeks.
10868604|NCT00402896|EG000|Reported Event|ZD6474|300 mg/day orally for 10 weeks.
10868605|NCT00402987|BG000|Baseline|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
10868606|NCT00402987|BG001|Baseline|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
10868607|NCT00402987|BG002|Baseline|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
10868608|NCT00402987|BG003|Baseline|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
10868609|NCT00402987|BG004|Baseline|Total|Total of all reporting groups
10868610|NCT00402987|FG000|Participant Flow|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
10868611|NCT00402987|FG001|Participant Flow|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
10868612|NCT00402987|FG002|Participant Flow|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
11348764|NCT04136444|EG000|Reported Event|Cohort A Single Dose (SS)|Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 as oral tablets. Participants formed the Safety Set (SS).
10868613|NCT00402987|FG003|Participant Flow|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
10868614|NCT00402987|OG000|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
10868615|NCT00402987|OG001|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
10868616|NCT00402987|OG000|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
10868617|NCT00402987|OG001|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
10868618|NCT00402987|OG002|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
10868619|NCT00402987|OG001|Outcome|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
10868620|NCT00402987|OG002|Outcome|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
10868621|NCT00402987|OG003|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
10868622|NCT00402987|OG000|Outcome|Celecoxib 50mg/50mg|
10868623|NCT00402987|OG001|Outcome|Celecoxib 100mg (Pooled)|
10868624|NCT00402987|OG002|Outcome|Placebo|
10868625|NCT00402987|OG001|Outcome|Celecoxib 100 mg / Placebo|
10868626|NCT00402987|OG002|Outcome|Celecoxib 100mg / 50mg|
10868627|NCT00402987|OG003|Outcome|Placebo|
10868628|NCT00402987|OG001|Outcome|Celecoxib 100 mg (Pooled)|
10868629|NCT00402987|OG001|Outcome|Celecoxib 100mg/Placebo|
10868630|NCT00402987|OG002|Outcome|Celecoxib 100mg/50mg|
10868631|NCT00402987|OG001|Outcome|Celecoxib 100mg /Placebo|
10868632|NCT00402987|EG000|Reported Event|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
10868633|NCT00402987|EG001|Reported Event|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
10868634|NCT00402987|EG002|Reported Event|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
10868635|NCT00402987|EG003|Reported Event|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
10868636|NCT00403117|BG000|Baseline|Overall Number of Baseline Participants|Baseline measures are only reported for the 29 participants who completed the study.
10868637|NCT00403117|FG000|Participant Flow|Overall Study Participant Flow|Of the 49 participants enrolled, only 29 completed all 10 drug interventions.
10868638|NCT00403117|OG000|Outcome|Placebo + Marijuana (0.0%THC)|Placebo + Marijuana (0.0%THC)
10868639|NCT00403117|OG001|Outcome|Placebo + Marijuana (3.27% THC)|Placebo + Marijuana (3.27% THC)
10868640|NCT00403117|OG002|Outcome|Naltrexone (12mg) + Marijuana (0.0%THC)|Naltrexone (12mg) + marijuana (0.0%THC)
10868641|NCT00403117|OG003|Outcome|Naltrexone (12mg) + Marijuana (3.27%THC)|Naltrexone (12mg) + marijuana (3.27%THC)
10868642|NCT00403117|OG004|Outcome|Naltrexone (25mg) + Marijuana (0.0%THC)|Naltrexone (25mg) + marijuana (0.0%THC)
10868643|NCT00403117|OG005|Outcome|Naltrexone (25mg) + Marijuana (3.27%THC)|Naltrexone (25mg) + marijuana (3.27%THC)
10868644|NCT00403117|OG006|Outcome|Naltrexone (50mg) + Marijuana (0.0%THC)|Naltrexone (50mg) + marijuana (0.0%THC)
10868645|NCT00403117|OG007|Outcome|Naltrexone (50mg) + Marijuana (3.27%THC)|Naltrexone (50mg) + marijuana (3.27%THC)
10868646|NCT00403117|OG008|Outcome|Naltrexone (100mg) + Marijuana (0.0%THC)|Naltrexone (100mg) + marijuana (0.0%THC)
10868647|NCT00403117|OG009|Outcome|Naltrexone (100mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
11348765|NCT04136444|EG001|Reported Event|Cohort B Single Dose (SS)|Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 as oral tablets. Participants formed the SS.
10868648|NCT00403117|OG000|Outcome|Placebo + Marijuana (0.0%THC)|"Placebo Inactive marijuana (0.0% THC)~Naltrexone: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak.~Marijuana: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak."
10868649|NCT00403117|OG001|Outcome|Placebo + Marijuana (3.27% THC)|"Placebo marijuana (3.27% THC)~Naltrexone: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak.~Marijuana: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak."
10868650|NCT00403117|OG002|Outcome|Naltrexone (12mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
10868651|NCT00403117|OG003|Outcome|Naltrexone (12mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
10868652|NCT00403117|OG004|Outcome|Naltrexone (25mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
10868653|NCT00403117|OG005|Outcome|Naltrexone (25mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
10868654|NCT00403117|OG006|Outcome|Naltrexone (50mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
10868655|NCT00403117|OG007|Outcome|Naltrexone (50mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
10868656|NCT00403117|OG008|Outcome|Naltrexone (100mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
10868657|NCT00403117|EG000|Reported Event|Placebo + Inactive Marijuana (0.0%THC)|In this arm, participants received placebo + inactive marijuana (0.0%THC)
10868658|NCT00403117|EG001|Reported Event|Placebo + Marijuana (3.27% THC)|In this arm, participants received placebo + Marijuana (3.27% THC)
10868659|NCT00403117|EG002|Reported Event|Naltrexone (12mg) + Marijuana (0.0%THC)|In this arm, participants received naltrexone (12mg) + marijuana (0.0%THC)
10868660|NCT00403117|EG003|Reported Event|Naltrexone (12mg) + Marijuana (3.27%THC)|In this arm, participants received naltrexone (12mg) + marijuana (3.27%THC)
10868661|NCT00403117|EG004|Reported Event|Naltrexone (25mg) + Marijuana (0.0%THC)|In this arm, participants received naltrexone (25mg) + marijuana (0.0%THC)
10868662|NCT00403117|EG005|Reported Event|Naltrexone (25mg) + Marijuana (3.27%THC)|In this arm, participants received naltrexone (25mg) + marijuana (3.27%THC)
10868663|NCT00403117|EG006|Reported Event|Naltrexone (50mg) + Marijuana (0.0%THC)|In this arm, participants received naltrexone (50mg) + marijuana (0.0%THC)
10868664|NCT00403117|EG007|Reported Event|Naltrexone (50mg) + Marijuana (3.27%THC)|In this arm, participants received naltrexone (50mg) + marijuana (3.27%THC)
10868665|NCT00403117|EG008|Reported Event|Naltrexone (100mg) + Marijuana (0.0%THC)|In this arm, participants received naltrexone (100mg) + marijuana (0.0%THC)
10868666|NCT00403117|EG009|Reported Event|Naltrexone (100mg) + Marijuana (3.27%THC)|In this arm, participants received naltrexone (100mg) + marijuana (3.27%THC)
10868667|NCT00403130|BG000|Baseline|Gemcitabine + Paclitaxel + Bevacizumab|"Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles~Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles~Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles"
10868668|NCT00403130|FG000|Participant Flow|Gemcitabine + Paclitaxel + Bevacizumab|"Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles~Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles~Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles"
10868669|NCT00403130|OG000|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|"Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles~Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles~Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles"
10868670|NCT00403130|EG000|Reported Event|Gemcitabine + Paclitaxel + Bevacizumab|"Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles~Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles~Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles"
10868671|NCT00403234|BG000|Baseline|Placebo|Placebo transdermal patch applied for 7-day wear
10868672|NCT00403234|BG001|Baseline|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
10868673|NCT00403234|BG002|Baseline|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10868674|NCT00403234|BG003|Baseline|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
10868675|NCT00403234|BG004|Baseline|Total|Total of all reporting groups
10868676|NCT00403234|FG000|Participant Flow|Placebo|Placebo transdermal patch applied for 7-day wear.
10868677|NCT00403234|FG001|Participant Flow|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
10868678|NCT00403234|FG002|Participant Flow|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10868679|NCT00403234|FG003|Participant Flow|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
10868680|NCT00403234|OG000|Outcome|Placebo|Placebo transdermal patch applied for 7-day wear
10868681|NCT00403234|OG001|Outcome|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
10868682|NCT00403234|OG002|Outcome|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10868683|NCT00403234|OG003|Outcome|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
10868684|NCT00403234|EG000|Reported Event|Placebo|Placebo transdermal patch applied for 7-day wear.
10868685|NCT00403234|EG001|Reported Event|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
10868686|NCT00403234|EG002|Reported Event|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
10868687|NCT00403234|EG003|Reported Event|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
10868688|NCT00403260|BG000|Baseline|Pyronaridine - Artesunate|Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
10868689|NCT00403260|BG001|Baseline|Mefloquine Plus Artesunate|Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
10868690|NCT00403260|BG002|Baseline|Total|Total of all reporting groups
10868691|NCT00403260|FG000|Participant Flow|Pyronaridine - Artesunate|Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
10868692|NCT00403260|FG001|Participant Flow|Mefloquine Plus Artesunate|Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
10868693|NCT00403260|OG000|Outcome|Pyronaridine - Artesunate|Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
10868694|NCT00403260|OG001|Outcome|Mefloquine Plus Artesunate|Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
10868695|NCT00403260|EG000|Reported Event|Pyronaridine - Artesunate|"Pyronaridine artesunate (180:60mg)~Pyronaridine artesunate: once a day for 3 days"
10868696|NCT00403260|EG001|Reported Event|Mefloquine Plus Artesunate|"Mefloquine (250mg) plus artesunate (100mg)~Mefloquine plus artesunate: once a day for 3 days"
10868697|NCT00403273|BG000|Baseline|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
10868698|NCT00403273|BG001|Baseline|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
10868699|NCT00403273|BG002|Baseline|Total|Total of all reporting groups
11348766|NCT04136444|EG002|Reported Event|Cohort A Multiple Dose (SS)|Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
10868700|NCT00403273|FG000|Participant Flow|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
10868701|NCT00403273|FG001|Participant Flow|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
10868702|NCT00403273|OG000|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
10868703|NCT00403273|OG001|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
10868704|NCT00403273|OG000|Outcome|WOMAC Pain Responder|A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
10868705|NCT00403273|OG001|Outcome|WOMAC Pain Non-responder|A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
10868706|NCT00403273|EG000|Reported Event|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
10868707|NCT00403273|EG001|Reported Event|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
10868708|NCT00403390|BG000|Baseline|Group 1|Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
10868709|NCT00403390|BG001|Baseline|Group 2|Generic levothyroxine 8 weeks, then branded Synthroid 8 weeks
10868710|NCT00403390|BG002|Baseline|Total|Total of all reporting groups
10868711|NCT00403390|FG000|Participant Flow|Group 1|Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
10868712|NCT00403390|FG001|Participant Flow|Group 2|Generic levothyroxine for 8 weeks then branded Synthroid for 8 weeks
10868713|NCT00403390|OG000|Outcome|Group 1|Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
10868714|NCT00403390|OG001|Outcome|Group 2|Generic levothyroxine 8 weeks, then Branded Synthroid 8 weeks
10868715|NCT00403390|EG000|Reported Event|Group 1|Crossover; Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
10868716|NCT00403390|EG001|Reported Event|Group 2|Crossover; Generic levothyroxine 8 weeks, then Branded Synthroid 8 weeks, then generic
10868717|NCT00403403|BG000|Baseline|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
10868718|NCT00403403|BG001|Baseline|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
10868719|NCT00403403|BG002|Baseline|Total|Total of all reporting groups
10868720|NCT00403403|FG000|Participant Flow|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
10868721|NCT00403403|FG001|Participant Flow|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
10868722|NCT00403403|OG000|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
10868723|NCT00403403|OG001|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
10868724|NCT00403403|EG000|Reported Event|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
10868725|NCT00403403|EG001|Reported Event|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
10868726|NCT00403455|BG000|Baseline|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
10868727|NCT00403455|FG000|Participant Flow|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
10868728|NCT00403455|OG000|Outcome|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
10868729|NCT00403455|EG000|Reported Event|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
10868730|NCT00403481|BG000|Baseline|Active Treatmant Arm|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
10868731|NCT00403481|FG000|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
10868732|NCT00403481|OG000|Outcome|Overall Study Population|
10868733|NCT00403481|EG000|Reported Event|Olmesartan 20 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
10868734|NCT00403481|EG001|Reported Event|Olmesartan 40 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
11348767|NCT04136444|EG003|Reported Event|Cohort B Multiple Dose (SS)|Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
10868735|NCT00403481|EG002|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
10868736|NCT00403481|EG003|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 25 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
10868737|NCT00403494|BG000|Baseline|Sapropterin Dihydrochloride|Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.
10868738|NCT00403494|BG001|Baseline|Placebo|Subjects receive matching oral Placebo twice daily for 24 weeks.
10868739|NCT00403494|BG002|Baseline|Total|Total of all reporting groups
10868740|NCT00403494|FG000|Participant Flow|Sapropterin Dihydrochloride|Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.
10868741|NCT00403494|FG001|Participant Flow|Placebo|Subjects receive matching oral Placebo twice daily for 24 week.
10868742|NCT00403494|OG000|Outcome|Sapropterin Dihydrochloride|Intent to Treat Population. Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks
10868743|NCT00403494|OG001|Outcome|Placebo|Intent to Treat Population. Subjects receive matching oral Placebo twice daily for 24 weeks.
10868744|NCT00403494|OG000|Outcome|Sapropterin Dihydrochloride|Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.
10868745|NCT00403494|OG001|Outcome|Placebo|Subjects receive matching oral Placebo twice daily for 24 weeks.
10868746|NCT00403494|EG000|Reported Event|Sapropterin Dihydrochloride|Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.
10868747|NCT00403494|EG001|Reported Event|Placebo|Subjects receive matching oral Placebo twice daily for 24 weeks.
11223185|NCT02351700|FG000|Participant Flow|Opioid-sparing Group|"Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.~IV Caldolor (IV Ibuprofen): Compare addition of IV Caldolor (IV ibuprofen) intraoperatively and postoperatively against IV ibuprofen placebo added intraoperatively and postoperatively."
10868748|NCT00403546|BG000|Baseline|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
10868749|NCT00403546|BG001|Baseline|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
10868750|NCT00403546|BG002|Baseline|Total|Total of all reporting groups
10868751|NCT00403546|FG000|Participant Flow|Standard Treatment Ziprasidone|Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial. Participants who were already taking standard treatment ziprasidone for 3 weeks or longer at time of enrollment were eligible for screening, as well.
10868752|NCT00403546|FG001|Participant Flow|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
10868753|NCT00403546|FG002|Participant Flow|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
10868754|NCT00403546|OG000|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
10868755|NCT00403546|OG001|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
10868756|NCT00403546|OG000|Outcome|High Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
10868757|NCT00403546|EG000|Reported Event|Standard Treatment Ziprasidone Open-label Phase|Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial.
10868758|NCT00403546|EG001|Reported Event|Standard Treatment Ziprasidone Screening Phase|Participants who had taken standard treatment ziprasidone for 3 weeks or longer were eligible for screening to enter the randomized trial.
10868759|NCT00403546|EG002|Reported Event|High-Dose Ziprasidone Randomized Trial|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
10868760|NCT00403546|EG003|Reported Event|Placebo, Standard Treatment Ziprasidone Randomized Trial|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
10879176|NCT00455923|BG001|Baseline|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
10879177|NCT00455923|BG002|Baseline|Total|Total of all reporting groups
10879178|NCT00455923|FG000|Participant Flow|Seretide|Eligible participants received a starting dose of 50/100 micrograms (mcg) Seretide (combination of salmeterol/fluticasone propionate (Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
10879179|NCT00455923|FG001|Participant Flow|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
10879180|NCT00455923|OG000|Outcome|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
10879181|NCT00455923|OG001|Outcome|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
10879182|NCT00455923|EG000|Reported Event|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
10879183|NCT00455923|EG001|Reported Event|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
10879184|NCT00455962|BG000|Baseline|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
10879185|NCT00455962|BG001|Baseline|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
10879186|NCT00455962|BG002|Baseline|Total|Total of all reporting groups
11348768|NCT04124536|BG000|Baseline|HIV-Positive Intervention|"Combination strategy for partner HIV testing~HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm."
11348769|NCT04124536|BG001|Baseline|HIV-Positive Control|"Single strategy for partner HIV testing~Standard partner notification services."
10879187|NCT00455962|FG000|Participant Flow|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
10879188|NCT00455962|FG001|Participant Flow|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
10879189|NCT00455962|OG000|Outcome|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
10868761|NCT00403585|BG000|Baseline|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
10868762|NCT00403585|FG000|Participant Flow|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
10868763|NCT00403585|OG000|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
10868764|NCT00403585|EG000|Reported Event|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
10868765|NCT00403754|BG000|Baseline|Entire Study Population|"The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868766|NCT00403754|FG000|Participant Flow|Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol|"In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868767|NCT00403754|FG001|Participant Flow|Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868768|NCT00403754|FG002|Participant Flow|Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
10868769|NCT00403754|FG003|Participant Flow|Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol|"In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
10868770|NCT00403754|OG000|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868771|NCT00403754|OG001|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10879190|NCT00455962|OG001|Outcome|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
11336551|NCT03568500|OG002|Outcome|First Episode Psychosis|Participants had a confirmed clinical diagnosis of first episode psychosis using case note review. The duration of illness was defined as less than 3 years since presentation to the mental health team or first antipsychotic prescription. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.
11336552|NCT03568500|OG003|Outcome|Total|Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.
10846202|NCT00274287|BG000|Baseline|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
10846203|NCT00274287|FG000|Participant Flow|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
10846204|NCT00274287|OG000|Outcome|GM-CSF (Leukine)|Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
10846205|NCT00274287|OG000|Outcome|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
11348770|NCT04124536|BG002|Baseline|HIV-Negative Intervention|"Combination strategy for partner HIV testing~HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm."
10846206|NCT00274287|EG000|Reported Event|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
10846207|NCT00274456|BG000|Baseline|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
10846208|NCT00274456|BG001|Baseline|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
10846209|NCT00274456|BG002|Baseline|ABI-007 150 mg/m^2|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest.
10846210|NCT00274456|BG003|Baseline|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
10846211|NCT00274456|BG004|Baseline|Total|Total of all reporting groups
10846212|NCT00274456|FG000|Participant Flow|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
10846213|NCT00274456|FG001|Participant Flow|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
10846214|NCT00274456|FG002|Participant Flow|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
10846215|NCT00274456|FG003|Participant Flow|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
10846216|NCT00274456|OG000|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
10846217|NCT00274456|OG001|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
10846218|NCT00274456|OG002|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
10846219|NCT00274456|OG003|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
10846220|NCT00274456|EG000|Reported Event|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
10846221|NCT00274456|EG001|Reported Event|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
10846222|NCT00274456|EG002|Reported Event|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
10846223|NCT00274456|EG003|Reported Event|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
10846224|NCT00274469|BG000|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
10846225|NCT00274469|BG001|Baseline|Anastrozole 1 mg|Anastrozole 1 mg
10846226|NCT00274469|BG002|Baseline|Total|Total of all reporting groups
10846227|NCT00274469|FG000|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
10846228|NCT00274469|FG001|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg
10846229|NCT00274469|OG000|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
10846230|NCT00274469|OG001|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
10846231|NCT00274469|EG000|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
10846232|NCT00274469|EG001|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg
10846233|NCT00274625|BG000|Baseline|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
10846234|NCT00274625|BG001|Baseline|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
10846235|NCT00274625|BG002|Baseline|Total|Total of all reporting groups
10846236|NCT00274625|FG000|Participant Flow|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
10846237|NCT00274625|FG001|Participant Flow|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
10846238|NCT00274625|OG000|Outcome|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
10846239|NCT00274625|OG001|Outcome|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
10846240|NCT00274625|EG000|Reported Event|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
10846241|NCT00274625|EG001|Reported Event|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
10846242|NCT00274651|BG000|Baseline|CTCL (ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
10846243|NCT00274651|BG001|Baseline|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
10846244|NCT00274651|BG002|Baseline|Total|Total of all reporting groups
10846245|NCT00274651|FG000|Participant Flow|Arm A (CTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
10846246|NCT00274651|FG001|Participant Flow|Arm B (PTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
10846247|NCT00274651|OG000|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
10846248|NCT00274651|OG000|Outcome|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
10846249|NCT00274651|OG001|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
10846250|NCT00274651|EG000|Reported Event|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
10846251|NCT00274651|EG001|Reported Event|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
10846252|NCT00274716|BG000|Baseline|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
10846253|NCT00274716|BG001|Baseline|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
10846254|NCT00274716|BG002|Baseline|High BMI:MK-0916 6mg→MK-0916 6mg|Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B
10846255|NCT00274716|BG003|Baseline|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846256|NCT00274716|BG004|Baseline|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846257|NCT00274716|BG005|Baseline|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846258|NCT00274716|BG006|Baseline|Total|Total of all reporting groups
10846259|NCT00274716|FG000|Participant Flow|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
10846260|NCT00274716|FG001|Participant Flow|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
10846261|NCT00274716|FG002|Participant Flow|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846262|NCT00274716|FG003|Participant Flow|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846263|NCT00274716|FG004|Participant Flow|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846264|NCT00274716|FG005|Participant Flow|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846265|NCT00274716|OG000|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
10846266|NCT00274716|OG001|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
10846267|NCT00274716|OG002|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
10846268|NCT00274716|OG003|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
10846269|NCT00274716|OG000|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
10846270|NCT00274716|OG001|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
10846271|NCT00274716|OG002|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846272|NCT00274716|OG003|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846273|NCT00274716|OG004|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846274|NCT00274716|OG005|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846275|NCT00274716|EG000|Reported Event|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
10846276|NCT00274716|EG001|Reported Event|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
10846277|NCT00274716|EG002|Reported Event|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846278|NCT00274716|EG003|Reported Event|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846279|NCT00274716|EG004|Reported Event|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846280|NCT00274716|EG005|Reported Event|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
10846281|NCT00274742|BG000|Baseline|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846282|NCT00274742|BG001|Baseline|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846283|NCT00274742|BG002|Baseline|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846284|NCT00274742|BG003|Baseline|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846285|NCT00274742|BG004|Baseline|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
10846286|NCT00274742|BG005|Baseline|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846287|NCT00274742|BG006|Baseline|Total|Total of all reporting groups
10846288|NCT00274742|FG000|Participant Flow|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846289|NCT00274742|FG001|Participant Flow|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846290|NCT00274742|FG002|Participant Flow|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846291|NCT00274742|FG003|Participant Flow|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10868772|NCT00403754|OG002|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868773|NCT00403754|OG003|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868774|NCT00403754|OG004|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868775|NCT00403754|EG000|Reported Event|Indacaterol 150 μg|"1 Indacaterol 150 μg capsule + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 150 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868776|NCT00403754|EG001|Reported Event|Indacaterol 300 μg|"1 Indacaterol 300 μg capsules + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 300 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868777|NCT00403754|EG002|Reported Event|Indacaterol 600 μg|"2 Indacaterol 300 μg capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 600 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868778|NCT00403754|EG003|Reported Event|Placebo|"2 Placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Placebo treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
10868779|NCT00403754|EG004|Reported Event|Salmeterol 100 μg|Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
10868780|NCT00403767|BG000|Baseline|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
10868781|NCT00403767|BG001|Baseline|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
10868782|NCT00403767|BG002|Baseline|Total|Total of all reporting groups
10868783|NCT00403767|FG000|Participant Flow|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
10868784|NCT00403767|FG001|Participant Flow|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
10868785|NCT00403767|OG000|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
10868786|NCT00403767|OG001|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
10868787|NCT00403767|EG000|Reported Event|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
10868788|NCT00403767|EG001|Reported Event|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
10868789|NCT00403845|BG000|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868790|NCT00403845|FG000|Participant Flow|Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg|In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868791|NCT00403845|FG001|Participant Flow|Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg|In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868792|NCT00403845|FG002|Participant Flow|Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg|In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
11348771|NCT04124536|BG003|Baseline|HIV-Negative Control|"Single strategy for partner HIV testing~Partner notification services adapted for partners of HIV-negative women."
11348772|NCT04124536|BG004|Baseline|Healthcare Workers|Healthcare workers who were involved in different aspects of male partner HIV testing and included study staff members.
10868793|NCT00403845|FG003|Participant Flow|Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo|In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868794|NCT00403845|OG000|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868795|NCT00403845|OG001|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868796|NCT00403845|OG002|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868797|NCT00403845|OG003|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868798|NCT00403845|EG000|Reported Event|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868799|NCT00403845|EG001|Reported Event|Indacaterol 150 μg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868800|NCT00403845|EG002|Reported Event|Indacaterol 300 μg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868801|NCT00403845|EG003|Reported Event|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10868802|NCT00404066|BG000|Baseline|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
10868803|NCT00404066|FG000|Participant Flow|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
11348773|NCT04124536|BG005|Baseline|Total|Total of all reporting groups
10868804|NCT00404066|OG000|Outcome|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
10868805|NCT00404066|EG000|Reported Event|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
10868806|NCT00404079|BG000|Baseline|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
10868807|NCT00404079|BG001|Baseline|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
10868808|NCT00404079|BG002|Baseline|Total|Total of all reporting groups
10868809|NCT00404079|FG000|Participant Flow|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
10868810|NCT00404079|FG001|Participant Flow|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
10868811|NCT00404079|OG000|Outcome|Placebo|Oral intake of placebo capsules
10868812|NCT00404079|OG001|Outcome|Glucosamine Sulphate|Glucosamine sulphate was taken daily and orally in capsule forms for 6 months
10868813|NCT00404079|EG000|Reported Event|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
10868814|NCT00404079|EG001|Reported Event|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
10868815|NCT00404092|BG000|Baseline|1st Cohort|"70mg 1x/day~caspofungin : i.v."
10868816|NCT00404092|BG001|Baseline|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
10868817|NCT00404092|BG002|Baseline|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
10868818|NCT00404092|BG003|Baseline|4th Cohort|"200mg 1x/day~caspofungin : i.v."
10868819|NCT00404092|BG004|Baseline|Total|Total of all reporting groups
10868820|NCT00404092|FG000|Participant Flow|1st Cohort|"70mg 1x/day~caspofungin : i.v."
10868821|NCT00404092|FG001|Participant Flow|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
10868822|NCT00404092|FG002|Participant Flow|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
10868823|NCT00404092|FG003|Participant Flow|4th Cohort|"200mg 1x/day~caspofungin : i.v."
10868824|NCT00404092|OG000|Outcome|1st Cohort|"70mg 1x/day~caspofungin : i.v."
10868825|NCT00404092|OG001|Outcome|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
10868826|NCT00404092|OG002|Outcome|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
10868827|NCT00404092|OG003|Outcome|4th Cohort|"200mg 1x/day~caspofungin : i.v."
10868828|NCT00404092|EG000|Reported Event|1st Cohort|"70mg 1x/day~caspofungin : i.v."
10868829|NCT00404092|EG001|Reported Event|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
10868830|NCT00404092|EG002|Reported Event|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
10868831|NCT00404092|EG003|Reported Event|4th Cohort|"200mg 1x/day~caspofungin : i.v."
10868832|NCT00404235|BG000|Baseline|Cohort 1 (Prior Chemotherapy, PT)|Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
11348774|NCT04124536|FG000|Participant Flow|HIV-Positive Intervention|"Combination strategy for partner HIV testing~HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm."
10868833|NCT00404235|BG001|Baseline|Cohort 2 (Chemotherapy Naive, CN)|For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
10868834|NCT00404235|BG002|Baseline|Total|Total of all reporting groups
10868835|NCT00404235|FG000|Participant Flow|Cohort 1 (Prior Chemotherapy, PT)|Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
10868836|NCT00404235|FG001|Participant Flow|Cohort 2 (Chemotherapy Naive, CN)|For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
10868837|NCT00404235|OG000|Outcome|Cohort 1 (Prior Chemotherapy, PT)|Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
10868838|NCT00404235|OG001|Outcome|Cohort 2 (Chemotherapy Naive, CN)|For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
10868839|NCT00404235|EG000|Reported Event|Cohort 1 (Prior Chemotherapy, PT)|chemotherapy for their metastatic disease receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
10868840|NCT00404235|EG001|Reported Event|Cohort 2 (Chemotherapy Naive, CN)|prior chemotherapy for their metastatic disease, patients receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
10868841|NCT00404248|BG000|Baseline|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
10868842|NCT00404248|BG001|Baseline|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
10868843|NCT00404248|BG002|Baseline|Arm 3 no Stratification (+EIASD or -EIASD)|"Subjects were not stratified by antiseizure drugs~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Only dose tested: 2200.~NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
10868844|NCT00404248|BG003|Baseline|Total|Total of all reporting groups
10868845|NCT00404248|FG000|Participant Flow|Arm 1 Enzyme Inducing Antiseizure Drug (+ EIASD) Level 1|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~Pharmacokinetics (PK) data will be collected on day one of cycle one infusion"
11336553|NCT03568500|OG000|Outcome|Schizophrenia|Participants had a confirmed clinical diagnosis of schizophrenia (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the HCP.
10846292|NCT00274742|FG004|Participant Flow|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
10846293|NCT00274742|FG005|Participant Flow|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846294|NCT00274742|OG000|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846295|NCT00274742|OG001|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846296|NCT00274742|OG002|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846297|NCT00274742|OG003|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846298|NCT00274742|OG004|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
10846299|NCT00274742|OG005|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846300|NCT00274742|OG000|Outcome|Blinatumomab 5 µg/m²/d|Participants who received blinatumomab 5 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
10846301|NCT00274742|OG001|Outcome|Blinatumomab 15 µg/m²/d|Participants who received blinatumomab 15 µg/m²/day as continuous intravenous infusion in the first treatment cyle.
10846302|NCT00274742|OG002|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion in hte first treatment cycle.
10846303|NCT00274742|OG003|Outcome|Blinatumomab 60 µg/m²/d|Participants received blinatumomab 60 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
10846304|NCT00274742|OG004|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
10846305|NCT00274742|EG000|Reported Event|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846306|NCT00274742|EG001|Reported Event|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846307|NCT00274742|EG002|Reported Event|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846308|NCT00274742|EG003|Reported Event|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846309|NCT00274742|EG004|Reported Event|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
10846310|NCT00274742|EG005|Reported Event|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
10846311|NCT00274742|EG006|Reported Event|Blinatumomab Overall|All participants who received any dose of blinatumomab
10846312|NCT00274768|BG000|Baseline|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
10846313|NCT00274768|FG000|Participant Flow|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
10846314|NCT00274768|OG000|Outcome|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
10846315|NCT00274768|EG000|Reported Event|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
10846316|NCT00274781|BG000|Baseline|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
10846317|NCT00274781|FG000|Participant Flow|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
10846837|NCT00280241|OG000|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
10868846|NCT00404248|FG001|Participant Flow|Arm 2 +EIASD Level 2|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation."
10868847|NCT00404248|FG002|Participant Flow|Arm 3 +EIASD Level 3|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation. Includes pts at the new formulation TC6 at 1700mg"
10868848|NCT00404248|FG003|Participant Flow|Arm 4 +EIASD Level 4|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation."
10868849|NCT00404248|FG004|Participant Flow|Arm 5 Non-Enzyme Inducing Antiseizure Drug (-EIASD) Level 1|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
10868850|NCT00404248|FG005|Participant Flow|Arm 6 -EIASD Level 2|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
11348775|NCT04124536|FG001|Participant Flow|HIV-Positive Control|"Single strategy for partner HIV testing~Standard partner notification services."
10868851|NCT00404248|FG006|Participant Flow|Arm 7 -EIASD Level 3|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation. this Arm including pts treated at the new formulation TC6 at 1700mg~PK data will be collected on day one of cycle one infusion"
10868852|NCT00404248|FG007|Participant Flow|Arm 8 -EIASD Level 4|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
10868853|NCT00404248|FG008|Participant Flow|Arm 9 - Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day. New formulation TC6."
10868854|NCT00404248|OG000|Outcome|Arm 1 +EIASD (Enzyme-inducing Antizeizure Drug)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5~NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
10868855|NCT00404248|OG001|Outcome|ARM 2 -EIASD (Enzyme-inducing Antizeizure Drug)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5~NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
10868856|NCT00404248|OG002|Outcome|ARM 3 (No Stratification)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6."
10868857|NCT00404248|OG000|Outcome|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868858|NCT00404248|OG001|Outcome|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868859|NCT00404248|OG002|Outcome|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation; Includes patientss at the new formulation TC6 (-PEG)"
10868860|NCT00404248|OG003|Outcome|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868861|NCT00404248|OG004|Outcome|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868862|NCT00404248|OG005|Outcome|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868863|NCT00404248|OG006|Outcome|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation and new TC6 -PEG Formulation - Pts treated from both formulations"
10868864|NCT00404248|OG007|Outcome|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868865|NCT00404248|OG008|Outcome|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6 - NONPEG or -PEG. (polyethylene glycol )"
10868866|NCT00404248|OG000|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
10868867|NCT00404248|OG001|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
10868868|NCT00404248|OG000|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
10868869|NCT00404248|EG000|Reported Event|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868870|NCT00404248|EG001|Reported Event|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868871|NCT00404248|EG002|Reported Event|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation; Includes pts at the new formulation TC6 (-PEG)"
10868872|NCT00404248|EG003|Reported Event|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868873|NCT00404248|EG004|Reported Event|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868874|NCT00404248|EG005|Reported Event|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868875|NCT00404248|EG006|Reported Event|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
10868876|NCT00404248|EG007|Reported Event|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
10868877|NCT00404248|EG008|Reported Event|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-seizure medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6 - NONPEG or -PEG."
10868878|NCT00404352|BG000|Baseline|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10868879|NCT00404352|BG001|Baseline|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10868880|NCT00404352|BG002|Baseline|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10868881|NCT00404352|BG003|Baseline|Total|Total of all reporting groups
10868882|NCT00404352|FG000|Participant Flow|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10868883|NCT00404352|FG001|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10868884|NCT00404352|FG002|Participant Flow|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10868885|NCT00404352|FG003|Participant Flow|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
10868886|NCT00404352|FG004|Participant Flow|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
10868887|NCT00404352|FG005|Participant Flow|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
10868888|NCT00404352|FG006|Participant Flow|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868889|NCT00404352|FG007|Participant Flow|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868890|NCT00404352|FG008|Participant Flow|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868891|NCT00404352|OG000|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10868892|NCT00404352|OG001|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10868893|NCT00404352|OG002|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10879191|NCT00455962|EG000|Reported Event|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
10868894|NCT00404352|OG000|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868895|NCT00404352|OG001|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868896|NCT00404352|OG002|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868897|NCT00404352|EG000|Reported Event|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10868898|NCT00404352|EG001|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10868899|NCT00404352|EG002|Reported Event|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
10868900|NCT00404352|EG003|Reported Event|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
10868901|NCT00404352|EG004|Reported Event|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
10868902|NCT00404352|EG005|Reported Event|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
10868903|NCT00404352|EG006|Reported Event|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868904|NCT00404352|EG007|Reported Event|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868905|NCT00404352|EG008|Reported Event|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
10868906|NCT00404495|BG000|Baseline|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
10868907|NCT00404495|BG001|Baseline|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
10868908|NCT00404495|BG002|Baseline|Total|Total of all reporting groups
10868909|NCT00404495|FG000|Participant Flow|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
10868910|NCT00404495|FG001|Participant Flow|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
10868911|NCT00404495|OG000|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
10868912|NCT00404495|OG001|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
10868913|NCT00404495|EG000|Reported Event|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
10868914|NCT00404495|EG001|Reported Event|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
10868915|NCT00404547|BG000|Baseline|Alvesco|320 mcg/day or 640 mcg/day
10868916|NCT00404547|BG001|Baseline|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
10868917|NCT00404547|BG002|Baseline|Total|Total of all reporting groups
10868918|NCT00404547|FG000|Participant Flow|Alvesco|320 mcg/day or 640 mcg/day
10868919|NCT00404547|FG001|Participant Flow|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
10868920|NCT00404547|OG000|Outcome|Alvesco|320 mcg/day or 640 mcg/day
10868921|NCT00404547|OG001|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
10868922|NCT00404547|EG000|Reported Event|Alvesco|320 mcg/day or 640 mcg/day
10868923|NCT00404547|EG001|Reported Event|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
10868924|NCT00404651|BG000|Baseline|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868925|NCT00404651|BG001|Baseline|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868926|NCT00404651|BG002|Baseline|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868927|NCT00404651|BG003|Baseline|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
10868928|NCT00404651|BG004|Baseline|Total|Total of all reporting groups
10868929|NCT00404651|FG000|Participant Flow|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868930|NCT00404651|FG001|Participant Flow|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868931|NCT00404651|FG002|Participant Flow|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868932|NCT00404651|FG003|Participant Flow|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
10868933|NCT00404651|OG000|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868934|NCT00404651|OG001|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868935|NCT00404651|OG002|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868936|NCT00404651|OG003|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
10868937|NCT00404651|EG000|Reported Event|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868938|NCT00404651|EG001|Reported Event|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868939|NCT00404651|EG002|Reported Event|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
10868940|NCT00404651|EG003|Reported Event|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
10868941|NCT00404755|BG000|Baseline|Bupropion|"bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
10868942|NCT00404755|FG000|Participant Flow|Bupropion|"this was the initial treatment given to all patients except one who was ineligible for bupropion and received escitalopram~bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
10868943|NCT00404755|OG000|Outcome|Bupropion|"bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
10868944|NCT00404755|OG001|Outcome|Escitalopram|"escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d~escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d"
10868945|NCT00404755|OG002|Outcome|Imipramine|"imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted~imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted"
10868946|NCT00404755|EG000|Reported Event|Escitalopram|"escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d~escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d"
10868947|NCT00404755|EG001|Reported Event|Bupropion|"bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
10868948|NCT00404755|EG002|Reported Event|Imipramine|"imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted~imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted"
10868949|NCT00404768|BG000|Baseline|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
10868950|NCT00404768|BG001|Baseline|Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
10868951|NCT00404768|BG002|Baseline|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
10868952|NCT00404768|BG003|Baseline|Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
10868953|NCT00404768|BG004|Baseline|Total|Total of all reporting groups
10868954|NCT00404768|FG000|Participant Flow|Part A/B: IV GSK221149A|Eligible participants received a single intravenous (IV) infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 milligrams (mg) matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 nanogram/milliliter (ng/mL).
10868955|NCT00404768|FG001|Participant Flow|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
10868956|NCT00404768|FG002|Participant Flow|Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a mean steady-state concentration (Css,ave) of 75 ng/mL.
10868957|NCT00404768|FG003|Participant Flow|Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
10868958|NCT00404768|OG000|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
10868959|NCT00404768|OG001|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
10868960|NCT00404768|OG002|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
10868961|NCT00404768|OG003|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
10868962|NCT00404768|OG000|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL
10868963|NCT00404768|OG001|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
10868964|NCT00404768|OG000|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
10868965|NCT00404768|OG001|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
10868966|NCT00404768|OG000|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
10868967|NCT00404768|EG000|Reported Event|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
10868968|NCT00404768|EG001|Reported Event|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
11348776|NCT04124536|FG002|Participant Flow|HIV-Negative Intervention|"Combination strategy for partner HIV testing~HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm."
10868969|NCT00404768|EG002|Reported Event|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
10868970|NCT00404768|EG003|Reported Event|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
10868971|NCT00404820|BG000|Baseline|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
10868972|NCT00404820|BG001|Baseline|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
10868973|NCT00404820|BG002|Baseline|Total|Total of all reporting groups
10868974|NCT00404820|FG000|Participant Flow|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
10868975|NCT00404820|FG001|Participant Flow|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
10868976|NCT00404820|OG000|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
10868977|NCT00404820|OG001|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
10868978|NCT00404820|EG000|Reported Event|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
10879192|NCT00455962|EG001|Reported Event|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
10868979|NCT00404820|EG001|Reported Event|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
10868980|NCT00404924|BG000|Baseline|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
10868981|NCT00404924|BG001|Baseline|Placebo|Placebo plus best supportive care
10868982|NCT00404924|BG002|Baseline|Total|Total of all reporting groups
10868983|NCT00404924|FG000|Participant Flow|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
10868984|NCT00404924|FG001|Participant Flow|Placebo|Placebo plus best supportive care
10868985|NCT00404924|OG000|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
10868986|NCT00404924|OG001|Outcome|Placebo|Placebo plus best supportive care
10868987|NCT00404924|EG000|Reported Event|Vandetanib|Vandetanib 300 mg
10868988|NCT00404924|EG001|Reported Event|Placebo|Placebo
10868989|NCT00405067|BG000|Baseline|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
10868990|NCT00405067|BG001|Baseline|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
10868991|NCT00405067|BG002|Baseline|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
10868992|NCT00405067|BG003|Baseline|Total|Total of all reporting groups
10868993|NCT00405067|FG000|Participant Flow|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
10868994|NCT00405067|FG001|Participant Flow|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
10868995|NCT00405067|FG002|Participant Flow|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
10868996|NCT00405067|OG000|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
10868997|NCT00405067|OG001|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
10868998|NCT00405067|OG002|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
11348777|NCT04124536|FG003|Participant Flow|HIV-Negative Control|"Single strategy for partner HIV testing~Partner notification services adapted for partners of HIV-negative women."
11348778|NCT04124536|FG004|Participant Flow|Healthcare Workers|Healthcare workers were interviewed about the trial interventions, to gain insights into its feasibility.
10868999|NCT00405067|EG000|Reported Event|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
10869000|NCT00405067|EG001|Reported Event|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
10869001|NCT00405067|EG002|Reported Event|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
10869002|NCT00405275|BG000|Baseline|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
10869003|NCT00405275|BG001|Baseline|Etanercept|Etanercept and Methotrexate
10869004|NCT00405275|BG002|Baseline|Total|Total of all reporting groups
10869005|NCT00405275|FG000|Participant Flow|Triple|"Hydroxychloroquine (400mg daily); Sulfasalazine (1g daily for 6 weeks, then increased to 2g daily; Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, etanercept (subcutaneous injection).~Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Etanercept at 24 weeks. This is denoted in results table below as switch. No switch participants remained on Triple therapy throughout the trial."
10869006|NCT00405275|FG001|Participant Flow|Etanercept|"Etanercept (50mg subcutaneous injections weekly); Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, triple: placebo hydroxychloroquine (tablets daily) and placebo sulfasalazine (tablets daily).~Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Triple. This is denoted in results table below as switch. No switch participants remained on Etanercept therapy throughout the trial."
10869007|NCT00405275|OG000|Outcome|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
10869008|NCT00405275|OG001|Outcome|Etanercept|Etanercept and Methotrexate
10869009|NCT00405275|EG000|Reported Event|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
10869010|NCT00405275|EG001|Reported Event|Etanercept|Etanercept and Methotrexate
10869011|NCT00405288|BG000|Baseline|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
10869012|NCT00405288|BG001|Baseline|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
10869013|NCT00405288|BG002|Baseline|Total|Total of all reporting groups
10869014|NCT00405288|FG000|Participant Flow|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
10869015|NCT00405288|FG001|Participant Flow|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
10869016|NCT00405288|OG000|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
10869017|NCT00405288|OG001|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
10869018|NCT00405288|EG000|Reported Event|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
10869019|NCT00405288|EG001|Reported Event|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
10869020|NCT00405353|BG000|Baseline|Testosterone Arm/ Group|All subjects underwent a 6-month observation period, followed by 12 months of open label testosterone treatment, using 10g of gel containing 100mg of testosterone (Androgel) applied topically. Brain MRIs were obtained every month from baseline (month 0) until the end of the trial (month 18). All 10 subjects completed all nineteen monthly scans.
10869021|NCT00405353|FG000|Participant Flow|Testosterone Arm/ Group|All subjects underwent a 6-month observation period, followed by 12 months of open label testosterone treatment, using 10g of gel containing 100mg of testosterone (Androgel) applied topically.
10869022|NCT00405353|OG000|Outcome|Testosterone Arm/ Group|All subjects underwent a 6-month observation period, followed by 12 months of open label testosterone treatment, using 10g of gel containing 100mg of testosterone (Androgel) applied topically.
10869023|NCT00405353|EG000|Reported Event|Testosterone Arm/ Group|All subjects underwent a 6-month observation period, followed by 12 months of open label testosterone treatment, using 10g of gel containing 100mg of testosterone (Androgel) applied topically.
10869024|NCT00405392|BG000|Baseline|Sequence A: Ibandronate 150 mg Then Risedronate 35 mg|Participants received treatment of ibandronate 150 mg tablet orally once monthly for 3 months in period 1 and then administered risedronate 35 mg tablet orally once weekly for 12 weeks in period 2 in sequence A. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
10869025|NCT00405392|BG001|Baseline|Sequence B: Risedronate 35 mg Then Ibandronate 150 mg|Participants received treatments of risedronate 35 mg tablet orally once weekly for 12 weeks in period 1 and then administered ibandronate 150 mg tablet orally once monthly for 3 months in period 2 in sequence B. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
10869026|NCT00405392|BG002|Baseline|Total|Total of all reporting groups
10869027|NCT00405392|FG000|Participant Flow|Sequence A: Ibandronate 150 mg Then Risedronate 35 mg|Participants received treatment of ibandronate 150 milligram (mg) tablet orally once monthly for 3 months in period 1 and then administered risedronate 35 mg tablet orally once weekly for 12 weeks in period 2 in sequence A. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
10869028|NCT00405392|FG001|Participant Flow|Sequence B: Risedronate 35 mg Then Ibandronate 150 mg|Participants received treatments of risedronate 35 mg tablet orally once weekly for 12 weeks in period 1 and then administered ibandronate 150 mg tablet orally once monthly for 3 months in period 2 in sequence B. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
10869029|NCT00405392|OG000|Outcome|Ibandronate 150 mg Once Monthly|Participants received ibandronate 150 mg tablet orally once in a month for 3 months either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
10869030|NCT00405392|OG001|Outcome|Risedronate 35 mg Once Weekly|Participants received risedronate 35 mg tablet orally once weekly for 12 weeks either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
10869031|NCT00405392|EG000|Reported Event|Ibandronate 150 mg Once Monthly|Participants received ibandronate 150 mg tablet orally once in a month for 3 months either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
10869032|NCT00405392|EG001|Reported Event|Risedronate 35 mg Once Weekly|Participants received risedronate 35 mg tablet orally once weekly for 12 weeks either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
10869033|NCT00405509|BG000|Baseline|Confirmed Respiratory Infection|participants who had the type of viral infection confirmed by assay
10869034|NCT00405509|BG001|Baseline|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
10869035|NCT00405509|BG002|Baseline|Total|Total of all reporting groups
10869036|NCT00405509|FG000|Participant Flow|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
10869037|NCT00405509|FG001|Participant Flow|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
10869038|NCT00405509|OG000|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
10869039|NCT00405509|OG001|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
10869040|NCT00405509|EG000|Reported Event|Confirmed Respiratory Virus|
10869041|NCT00405509|EG001|Reported Event|Unconfirmed Respiratory Infection|
10869042|NCT00405522|BG000|Baseline|2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil|Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
10869043|NCT00405522|BG001|Baseline|4.0 mg/kg Propofol and 0.5 ug/kg Remifentanil|Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
10869044|NCT00405522|BG002|Baseline|Total|Total of all reporting groups
10869045|NCT00405522|FG000|Participant Flow|2.0 mg/kg Propofol|Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
10869046|NCT00405522|FG001|Participant Flow|4.0 mg/kg Propofol|Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
10869047|NCT00405522|OG000|Outcome|2.0 mg/kg Propofol|Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
10869048|NCT00405522|OG001|Outcome|4.0 mg/kg Propofol|Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
10869049|NCT00405522|EG000|Reported Event|2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil|Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
10869050|NCT00405522|EG001|Reported Event|4.0 mg/kg Propofol + 0.5 ug/kg Remifentanil|Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
10869051|NCT00405548|BG000|Baseline|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
10869052|NCT00405548|BG001|Baseline|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
10869053|NCT00405548|BG002|Baseline|Total|Total of all reporting groups
10869054|NCT00405548|FG000|Participant Flow|BNP (Nesiritide)|Brain Natriuretic Peptide (BNP) 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
10869055|NCT00405548|FG001|Participant Flow|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
10869056|NCT00405548|OG000|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
10869057|NCT00405548|OG001|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
10869058|NCT00405548|EG000|Reported Event|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
10869059|NCT00405548|EG001|Reported Event|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
10869060|NCT00405587|BG000|Baseline|Dose Escalation: Original Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules in original (crystalline) formulation at a starting dose of 200 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 original formulation for 4 weeks. Dose escalation was continued up to 1600 mg BID dose level.
10869061|NCT00405587|BG001|Baseline|Dose Escalation: MBP Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules/tablets in MBP formulation at a starting dose of 160 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 MBP formulation for 4 weeks. Dose escalation was continued up to unacceptable toxicity or disease progression occurred.
10869062|NCT00405587|BG002|Baseline|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
10869063|NCT00405587|BG003|Baseline|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
10869064|NCT00405587|BG004|Baseline|Total|Total of all reporting groups
10869065|NCT00405587|FG000|Participant Flow|Dose Escalation: Original Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules in original (crystalline) formulation at a starting dose of 200 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 original formulation for 4 weeks. Dose escalation was continued up to 1600 mg BID dose level.
10879193|NCT00455975|BG000|Baseline|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
10869066|NCT00405587|FG001|Participant Flow|Dose Escalation: MBP Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules/tablets in MBP formulation at a starting dose of 160 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 MBP formulation for 4 weeks. Dose escalation was continued up to unacceptable toxicity or disease progression occurred.
10869067|NCT00405587|FG002|Participant Flow|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
10869068|NCT00405587|FG003|Participant Flow|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
10869069|NCT00405587|OG000|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
10869070|NCT00405587|OG001|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
10869071|NCT00405587|OG002|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
10869072|NCT00405587|OG003|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
10869073|NCT00405587|OG000|Outcome|Dose Escalation Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
10869074|NCT00405587|OG000|Outcome|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
10869075|NCT00405587|OG001|Outcome|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
10869076|NCT00405587|OG002|Outcome|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
10869077|NCT00405587|OG003|Outcome|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
10869078|NCT00405587|OG004|Outcome|Dose Escalation: MBP Formulation - 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
10869079|NCT00405587|OG005|Outcome|Dose Escalation: MBP Formulation - 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
10869080|NCT00405587|OG000|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
10869081|NCT00405587|OG001|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
10869082|NCT00405587|OG000|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
10869083|NCT00405587|OG000|Outcome|Dose Escalation: MBP Formulation -160 mg|Participants received RO5185426 hard gelatin capsules at a dose of 160 mg BID for 4 weeks.
10869084|NCT00405587|OG001|Outcome|Dose Escalation: MBP Formulation -240 mg|Participants received RO5185426 hard gelatin capsules at a dose of 240 mg BID for 4 weeks.
10869085|NCT00405587|OG002|Outcome|Dose Escalation: MBP Formulation -320 mg|Participants received RO5185426 hard gelatin capsules at a dose of 320 mg BID for 4 weeks.
10869086|NCT00405587|OG003|Outcome|Dose Escalation: MBP Formulation -360 mg|Participants received RO5185426 hard gelatin capsules at a dose of 360 mg BID for 4 weeks.
10869087|NCT00405587|OG004|Outcome|Dose Escalation: MBP Formulation -720 mg|Participants received RO5185426 hard gelatin capsules at a dose of 720 mg BID for 4 weeks.
10869088|NCT00405587|OG005|Outcome|Dose Escalation: MBP Formulation -1120 mg|Participants received RO5185426 hard gelatin capsules at a dose of 1120 mg BID for 4 weeks.
10869089|NCT00405587|OG000|Outcome|Dose Escalation: MBP Formulation - 80 mg Capsule|Participants received RO5185426 capsules in MBP formulation at a dose of 320 mg BID dose escalation/paired biopsy cohort, or 720 mg BID dose escalation/paired biopsy cohort, or 1120 mg BID dose escalation for 4 weeks.
10869090|NCT00405587|OG001|Outcome|Dose Escalation: MBP Formulation and Extension: BRAFV600E- Pos|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules in MBP formulation at a dose of 960 mg BID , or 960 mg BID dose escalation
10869091|NCT00405587|EG000|Reported Event|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
10869092|NCT00405587|EG001|Reported Event|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
10869093|NCT00405587|EG002|Reported Event|Dose Escalation: MBP Formulation - 320 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 320 mg BID for 4 weeks.
10869094|NCT00405587|EG003|Reported Event|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
10869095|NCT00405587|EG004|Reported Event|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
10869096|NCT00405587|EG005|Reported Event|Dose Escalation: MBP Formulation - 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
10869097|NCT00405587|EG006|Reported Event|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
10869098|NCT00405587|EG007|Reported Event|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
10869099|NCT00405587|EG008|Reported Event|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
10869100|NCT00405587|EG009|Reported Event|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
10869101|NCT00405587|EG010|Reported Event|Extension: BRAFV600E-Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185246 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
10869102|NCT00405587|EG011|Reported Event|Extension: BRAFV600E-Positive CRC|Participants with CRC that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185246 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
10869103|NCT00405639|BG000|Baseline|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
10869104|NCT00405639|BG001|Baseline|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
10869105|NCT00405639|BG002|Baseline|Total|Total of all reporting groups
10869106|NCT00405639|FG000|Participant Flow|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
10869107|NCT00405639|FG001|Participant Flow|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
10869108|NCT00405639|OG000|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
10869109|NCT00405639|OG001|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
10869110|NCT00405639|EG000|Reported Event|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
10869111|NCT00405639|EG001|Reported Event|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
10869112|NCT00405652|BG000|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
10869113|NCT00405652|FG000|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
10869114|NCT00405652|OG000|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
10869115|NCT00405652|EG000|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
10869116|NCT00405704|BG000|Baseline|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
10869117|NCT00405704|BG001|Baseline|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
10869118|NCT00405704|BG002|Baseline|Total|Total of all reporting groups
10869119|NCT00405704|FG000|Participant Flow|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
10869120|NCT00405704|FG001|Participant Flow|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
10869121|NCT00405704|OG000|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
10869122|NCT00405704|OG001|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
10869123|NCT00405704|OG000|Outcome|Trimethoprim-Sulfamethoxazole|Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
10869124|NCT00405704|EG000|Reported Event|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
10869125|NCT00405704|EG001|Reported Event|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
10869126|NCT00405756|BG000|Baseline|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869127|NCT00405756|BG001|Baseline|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869128|NCT00405756|BG002|Baseline|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869129|NCT00405756|BG003|Baseline|Total|Total of all reporting groups
10869130|NCT00405756|FG000|Participant Flow|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869131|NCT00405756|FG001|Participant Flow|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869132|NCT00405756|FG002|Participant Flow|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869133|NCT00405756|OG000|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869134|NCT00405756|OG001|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869135|NCT00405756|OG002|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869136|NCT00405756|EG000|Reported Event|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869137|NCT00405756|EG001|Reported Event|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869138|NCT00405756|EG002|Reported Event|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
10869139|NCT00405821|BG000|Baseline|Acyclovir 400mg Tablet Twice Daily|
10869140|NCT00405821|BG001|Baseline|Placebo Tablet Twice Daily|
10869141|NCT00405821|BG002|Baseline|Total|Total of all reporting groups
10869142|NCT00405821|FG000|Participant Flow|Acyclovir 400mg Tablet Twice Daily|
10869143|NCT00405821|FG001|Participant Flow|Placebo Tablet Twice Daily|
10869144|NCT00405821|OG000|Outcome|Acyclovir 400mg Tablet Twice Daily|
10869145|NCT00405821|OG001|Outcome|Placebo Tablet Twice Daily|
10869146|NCT00405821|EG000|Reported Event|Acyclovir 400mg Tablet Twice Daily|
10869147|NCT00405821|EG001|Reported Event|Placebo Tablet Twice Daily|
10869148|NCT00405912|BG000|Baseline|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
10869149|NCT00405912|BG001|Baseline|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
10869150|NCT00405912|BG002|Baseline|St. John's Wort - 1800 mg /Day|St. John's Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
10869151|NCT00405912|BG003|Baseline|Total|Total of all reporting groups
10869152|NCT00405912|FG000|Participant Flow|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
10869153|NCT00405912|FG001|Participant Flow|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
10869154|NCT00405912|FG002|Participant Flow|St. John's Wort - 1800 mg /Day|St. John's Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
10869155|NCT00405912|OG000|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
10869156|NCT00405912|OG001|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
10869157|NCT00405912|OG002|Outcome|St. John's Wort - 1800 mg /Day|St. John's Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
10869158|NCT00405912|EG000|Reported Event|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
10869159|NCT00405912|EG001|Reported Event|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
10869160|NCT00405912|EG002|Reported Event|St. John's Wort - 1800 mg /Day|St. John's Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
10869161|NCT00405938|BG000|Baseline|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
10869162|NCT00405938|BG001|Baseline|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
10869163|NCT00405938|BG002|Baseline|Total|Total of all reporting groups
10869164|NCT00405938|FG000|Participant Flow|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
10869165|NCT00405938|FG001|Participant Flow|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
10869166|NCT00405938|OG000|Outcome|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
10869167|NCT00405938|OG001|Outcome|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
10869168|NCT00405938|EG000|Reported Event|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
10869169|NCT00405938|EG001|Reported Event|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
10869170|NCT00406029|BG000|Baseline|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
10869171|NCT00406029|BG001|Baseline|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
10869172|NCT00406029|BG002|Baseline|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
10869173|NCT00406029|BG003|Baseline|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
10869174|NCT00406029|BG004|Baseline|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
10869175|NCT00406029|BG005|Baseline|Total|Total of all reporting groups
10869176|NCT00406029|FG000|Participant Flow|Preladenant 1 mg BID|Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period.
10869177|NCT00406029|FG001|Participant Flow|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
10869178|NCT00406029|FG002|Participant Flow|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
10869179|NCT00406029|FG003|Participant Flow|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
10869180|NCT00406029|FG004|Participant Flow|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
10869181|NCT00406029|OG000|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
10869182|NCT00406029|OG001|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
10869183|NCT00406029|OG002|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
10869184|NCT00406029|OG003|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
10869185|NCT00406029|OG004|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
10869186|NCT00406029|EG000|Reported Event|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
10869187|NCT00406029|EG001|Reported Event|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
10869188|NCT00406029|EG002|Reported Event|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
10869189|NCT00406029|EG003|Reported Event|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
10869190|NCT00406029|EG004|Reported Event|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
10869191|NCT00406107|BG000|Baseline|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
10869192|NCT00406107|BG001|Baseline|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0 mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
10869193|NCT00406107|BG002|Baseline|Total|Total of all reporting groups
10869194|NCT00406107|FG000|Participant Flow|Pegaptanib Sodium 0.3mg (Macugen)|
10869195|NCT00406107|FG001|Participant Flow|Pegaptanib Sodium 1 mg (Macugen)|
10869196|NCT00406107|OG000|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
10869197|NCT00406107|OG000|Outcome|Pegaptanib Sodium 0.3mg (Macugen)|Patients experiencing an ocular adverse event, in this case a retinal detachment
10869198|NCT00406107|OG001|Outcome|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
10869199|NCT00406107|EG000|Reported Event|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
10869200|NCT00406107|EG001|Reported Event|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
10869201|NCT00406133|BG000|Baseline|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
10869202|NCT00406133|BG001|Baseline|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
10869203|NCT00406133|BG002|Baseline|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
10869204|NCT00406133|BG003|Baseline|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
10869205|NCT00406133|BG004|Baseline|Total|Total of all reporting groups
10869206|NCT00406133|FG000|Participant Flow|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
10869207|NCT00406133|FG001|Participant Flow|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
10869208|NCT00406133|FG002|Participant Flow|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
10869209|NCT00406133|FG003|Participant Flow|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
10869210|NCT00406133|OG000|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
10869211|NCT00406133|OG001|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
10869212|NCT00406133|OG000|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
10869213|NCT00406133|OG001|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
10869214|NCT00406133|OG000|Outcome|Primary Cohort RT-CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
10869215|NCT00406133|OG000|Outcome|CGM Group|Participants who were randomized to CGM use
10869216|NCT00406133|OG001|Outcome|Control Group|Participants randomized to SMBG
10869217|NCT00406133|OG000|Outcome|CGM Group|Participants randomized to CGM Use
10869218|NCT00406133|OG001|Outcome|Primary Cohort Control Group|Participants with baseline HBA1c >=7.0% who were randomized to standard care
10869219|NCT00406133|EG000|Reported Event|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
10869220|NCT00406133|EG001|Reported Event|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
10869221|NCT00406133|EG002|Reported Event|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
10869222|NCT00406133|EG003|Reported Event|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
10869223|NCT00406276|BG000|Baseline|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
10869224|NCT00406276|FG000|Participant Flow|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
10869225|NCT00406276|OG000|Outcome|Docetaxel/RAD001|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
10869226|NCT00406276|OG000|Outcome|Docetaxel/RAD001|
10869227|NCT00406276|EG000|Reported Event|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
10869228|NCT00406315|BG000|Baseline|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
10869229|NCT00406315|FG000|Participant Flow|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
10869230|NCT00406315|OG000|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
10869231|NCT00406315|EG000|Reported Event|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
10869232|NCT00406354|BG000|Baseline|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
10869233|NCT00406354|BG001|Baseline|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
10869234|NCT00406354|BG002|Baseline|Placebo|matching placebo daily dose taken orally
10869235|NCT00406354|BG003|Baseline|Total|Total of all reporting groups
10869236|NCT00406354|FG000|Participant Flow|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
10869237|NCT00406354|FG001|Participant Flow|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
10869238|NCT00406354|FG002|Participant Flow|Placebo|matching placebo daily dose taken orally
10869239|NCT00406354|OG000|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
10869240|NCT00406354|OG001|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
10869241|NCT00406354|OG002|Outcome|Placebo|matching placebo daily dose taken orally
10869242|NCT00406354|EG000|Reported Event|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
10869243|NCT00406354|EG001|Reported Event|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
10869244|NCT00406354|EG002|Reported Event|Placebo|matching placebo daily dose taken orally
10869245|NCT00406367|BG000|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
10869246|NCT00406367|BG001|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
10869247|NCT00406367|BG002|Baseline|Total|Total of all reporting groups
10869248|NCT00406367|FG000|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
10869249|NCT00406367|FG001|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
10869250|NCT00406367|OG000|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
10869251|NCT00406367|OG001|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
10869252|NCT00406367|EG000|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
10869253|NCT00406367|EG001|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
10869254|NCT00406393|BG000|Baseline|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
10869255|NCT00406393|BG001|Baseline|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
10869256|NCT00406393|BG002|Baseline|Total|Total of all reporting groups
10869257|NCT00406393|FG000|Participant Flow|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
10869258|NCT00406393|FG001|Participant Flow|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
10869259|NCT00406393|OG000|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
10869260|NCT00406393|OG001|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
10869261|NCT00406393|EG000|Reported Event|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
10869262|NCT00406393|EG001|Reported Event|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
10869263|NCT00406419|BG000|Baseline|Placebo × 2 IV + MTX|Participants received two intravenous (IV) infusion matching placebo to ocrelizumab on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 milligram (mg) was administered weekly.
10869264|NCT00406419|BG001|Baseline|Ocrelizumab 200 mg × 2 IV + MTX|Participants received two IV infusion of ocrelizumab 200 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
10869265|NCT00406419|BG002|Baseline|Ocrelizumab 500 mg × 2 IV + MTX|Participants received two IV infusion of ocrelizumab 500 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
10869266|NCT00406419|BG003|Baseline|Total|Total of all reporting groups
10869267|NCT00406419|FG000|Participant Flow|Placebo × 2 IV + MTX|Participants received two intravenous (IV) infusion matching placebo to ocrelizumab on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 milligram (mg) was administered weekly.
10869268|NCT00406419|FG001|Participant Flow|Ocrelizumab 200 mg × 2 IV + MTX|Participants received two IV infusion of ocrelizumab 200 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
10869269|NCT00406419|FG002|Participant Flow|Ocrelizumab 500 mg × 2 IV + MTX|Participants received two IV infusion of ocrelizumab 500 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
10869270|NCT00406419|OG000|Outcome|Placebo × 2 IV + MTX|Participants received two intravenous (IV) infusion matching placebo to ocrelizumab on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 milligram (mg) was administered weekly.
10869271|NCT00406419|OG001|Outcome|Ocrelizumab 200 mg × 2 IV + MTX|Participants received two IV infusion of ocrelizumab 200 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
10869272|NCT00406419|OG002|Outcome|Ocrelizumab 500 mg × 2 IV + MTX|Participants received two IV infusion of ocrelizumab 500 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
10869273|NCT00406419|EG000|Reported Event|Placebo × 2 IV + MTX|Participants received two intravenous (IV) infusion matching placebo to ocrelizumab on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 milligram (mg) was administered weekly.
10869274|NCT00406419|EG001|Reported Event|Ocrelizumab 200 mg × 2 IV + MTX|Participants received two IV infusion of ocrelizumab 200 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
10869275|NCT00406419|EG002|Reported Event|Ocrelizumab 500 mg × 2 IV + MTX|Participants received two IV infusion of ocrelizumab 500 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
10869276|NCT00406640|BG000|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
10869277|NCT00406640|BG001|Baseline|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
10869278|NCT00406640|BG002|Baseline|Total|Total of all reporting groups
10879194|NCT00455975|BG001|Baseline|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
10879195|NCT00455975|BG002|Baseline|Total|Total of all reporting groups
10869279|NCT00406640|FG000|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
10869280|NCT00406640|FG001|Participant Flow|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
10869281|NCT00406640|OG000|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
10869282|NCT00406640|OG001|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
10869283|NCT00406640|OG000|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
10869284|NCT00406640|OG001|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
10869285|NCT00406640|OG000|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
10869286|NCT00406640|OG001|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
10869287|NCT00406640|OG000|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
10869288|NCT00406640|OG001|Outcome|Escitalopram (ESC)|Taper Phase Day 239 or at discontinuation: If patients taking escitalopram 20 mg/day, then decrease to 10 mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10 mg/day decreased to matching escitalopram placebo/day for 7 days.
10869289|NCT00406640|EG000|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
10879196|NCT00455975|FG000|Participant Flow|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
10879197|NCT00455975|FG001|Participant Flow|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
10879198|NCT00455975|OG000|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
10879199|NCT00455975|OG001|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
10879200|NCT00455975|EG000|Reported Event|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
10869290|NCT00406640|EG001|Reported Event|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
10869291|NCT00406653|BG000|Baseline|ABA 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
10869292|NCT00406653|BG001|Baseline|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869293|NCT00406653|BG002|Baseline|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
10869294|NCT00406653|BG003|Baseline|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869295|NCT00406653|BG004|Baseline|Total|Total of all reporting groups
10869296|NCT00406653|FG000|Participant Flow|Abatacept (ABA) 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
10869297|NCT00406653|FG001|Participant Flow|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869298|NCT00406653|FG002|Participant Flow|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
10869299|NCT00406653|FG003|Participant Flow|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869300|NCT00406653|FG004|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
10869301|NCT00406653|FG005|Participant Flow|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
10869302|NCT00406653|FG006|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
10869303|NCT00406653|OG000|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
10869304|NCT00406653|OG001|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
10869305|NCT00406653|OG002|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
10869306|NCT00406653|OG003|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869307|NCT00406653|OG000|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
10869308|NCT00406653|OG001|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
10869309|NCT00406653|OG000|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
10869310|NCT00406653|OG000|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869311|NCT00406653|OG001|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
10869312|NCT00406653|OG002|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
10869313|NCT00406653|OG003|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
10869314|NCT00406653|EG000|Reported Event|ABA 30/~10mg/kg (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
10869315|NCT00406653|EG001|Reported Event|ABA 3mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
10869316|NCT00406653|EG002|Reported Event|ABA ~10mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869317|NCT00406653|EG003|Reported Event|ABA ~10mg/kg (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
10869318|NCT00406653|EG004|Reported Event|ABA ~10mg/kg (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
10869319|NCT00406653|EG005|Reported Event|Placebo (IP)|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869320|NCT00406653|EG006|Reported Event|Placebo (MP)|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
10869321|NCT00406692|BG000|Baseline|Zonisamide|400 mg daily
10869322|NCT00406692|FG000|Participant Flow|Zonisamide|400 mg daily
10869323|NCT00406692|OG000|Outcome|Zonisamide|400 mg daily
10869324|NCT00406692|EG000|Reported Event|Zonisamide|400 mg daily
10879201|NCT00455975|EG001|Reported Event|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
10869325|NCT00406718|BG000|Baseline|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
10869326|NCT00406718|BG001|Baseline|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
10869327|NCT00406718|BG002|Baseline|Standard Treatment|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
10869328|NCT00406718|BG003|Baseline|Total|Total of all reporting groups
10869329|NCT00406718|FG000|Participant Flow|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
10869330|NCT00406718|FG001|Participant Flow|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
10869331|NCT00406718|FG002|Participant Flow|Treatment as Usual|"standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
10869332|NCT00406718|OG000|Outcome|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
10869333|NCT00406718|OG001|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
10869334|NCT00406718|OG002|Outcome|Standard|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
10869335|NCT00406718|OG000|Outcome|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
10869336|NCT00406718|OG002|Outcome|Treatment as Usual|"standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
10869337|NCT00406718|EG000|Reported Event|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
10869338|NCT00406718|EG001|Reported Event|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
10869339|NCT00406718|EG002|Reported Event|Standard Treatment|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
10869340|NCT00406848|BG000|Baseline|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
10869341|NCT00406848|BG001|Baseline|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
10869342|NCT00406848|BG002|Baseline|Total|Total of all reporting groups
10879202|NCT00456014|BG000|Baseline|SSRI|The single arm of this study involves patients with current MDD who will all receive open standardized treatment with escitalopram. There are not multiple arms nor multiple patient groups.
10869343|NCT00406848|FG000|Participant Flow|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
10869344|NCT00406848|FG001|Participant Flow|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
10869345|NCT00406848|OG000|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
10869346|NCT00406848|OG001|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
10869347|NCT00406848|OG001|Outcome|Placebo Non-rescue|Participants who were randomized to placebo at baseline and for whom treatment rescue was not required during continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they continued to receive placebo until completing or discontinuing from the study.
10869348|NCT00406848|OG002|Outcome|Placebo Rescue|Participants who were randomized to placebo at baseline and for whom rescue treatment was required during the continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally until completing or discontinuing from the study.
10869349|NCT00406848|EG000|Reported Event|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
10869350|NCT00406848|EG001|Reported Event|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity. Results are for the randomized placebo patients who reported events while they were on placebo.
10869351|NCT00406848|EG002|Reported Event|Rescued Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally for the remainder of the study. Results are for the randomized placebo patients who were rescued to duloxetine and reported events while they were on duloxetine.
10869352|NCT00407030|BG000|Baseline|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
10869353|NCT00407030|BG001|Baseline|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
10869354|NCT00407030|BG002|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
10869355|NCT00407030|BG003|Baseline|Total|Total of all reporting groups
10869356|NCT00407030|FG000|Participant Flow|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
10869357|NCT00407030|FG001|Participant Flow|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
10869358|NCT00407030|FG002|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
11336554|NCT03568500|OG001|Outcome|Schizoaffective Disorder|Participants had a confirmed clinical diagnosis of schizoaffective disorder (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the HCP.
10869359|NCT00407030|OG000|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
10869360|NCT00407030|OG001|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
10869361|NCT00407030|OG001|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
10869362|NCT00407030|OG002|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
10869363|NCT00407030|OG000|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
10869364|NCT00407030|EG000|Reported Event|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
10869365|NCT00407030|EG001|Reported Event|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
10869366|NCT00407030|EG002|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
10869367|NCT00407355|BG000|Baseline|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
10869368|NCT00407355|BG001|Baseline|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
10869369|NCT00407355|BG002|Baseline|Total|Total of all reporting groups
10869370|NCT00407355|FG000|Participant Flow|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
10869371|NCT00407355|FG001|Participant Flow|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
10869372|NCT00407355|OG000|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
10869373|NCT00407355|OG001|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
10869374|NCT00407355|EG000|Reported Event|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
10869375|NCT00407355|EG001|Reported Event|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
10869376|NCT00407381|BG000|Baseline|Ranibizumab Only|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
10869377|NCT00407381|BG001|Baseline|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
10869378|NCT00407381|BG002|Baseline|Laser With RBZ|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
10869379|NCT00407381|BG003|Baseline|Total|Total of all reporting groups
10869380|NCT00407381|FG000|Participant Flow|Ranibizumab Only|"Ranibizumab (RBZ) intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria."
10869381|NCT00407381|FG001|Participant Flow|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
10869382|NCT00407381|FG002|Participant Flow|Laser With Ranibizumab (RBZ)|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
10869383|NCT00407381|OG000|Outcome|RBZ Alone|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
10869384|NCT00407381|OG001|Outcome|Laser Alone|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
10869385|NCT00407381|OG002|Outcome|Laser With RBZ|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
10869386|NCT00407381|EG000|Reported Event|Ranibizumab Only|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
10869387|NCT00407381|EG001|Reported Event|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
10869388|NCT00407381|EG002|Reported Event|Laser With Ranibizumab|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
10869389|NCT00407420|BG000|Baseline|Allocated to Mandometer Group (54)|Received Mandometer therapy and lifestyle advice.
10869390|NCT00407420|BG001|Baseline|Control Arm (52)|Received lifestyle advice alone
10869391|NCT00407420|BG002|Baseline|Total|Total of all reporting groups
10869392|NCT00407420|FG000|Participant Flow|Allocated to Mandometer Group|Received Mandometer therapy and lifestyle advice.
10869393|NCT00407420|FG001|Participant Flow|Control Arm|Received lifestyle advice alone
10869394|NCT00407420|OG000|Outcome|Mandometer|"Active intervention - one meal eaten per day off Mandometer~mandometer~Mandometer: A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy."
10869395|NCT00407420|OG001|Outcome|Control|Nutritional and activity advice alone
10869396|NCT00407420|OG000|Outcome|Allocated to Mandometer Group (54)|Received Mandometer therapy and lifestyle advice.
10869397|NCT00407420|OG001|Outcome|Control Arm (52)|Received lifestyle advice alone
10869398|NCT00407420|EG000|Reported Event|Mandometer|"Active intervention - one meal eaten per day off Mandometer~mandometer~Mandometer: A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy."
10869399|NCT00407420|EG001|Reported Event|Control|"Nutritional and activity advice alone~mandometer"
10869400|NCT00407485|BG000|Baseline|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10869401|NCT00407485|FG000|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10869402|NCT00407485|OG000|Outcome|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10869403|NCT00407485|OG000|Outcome|Treatment (Ziv-aflibercept)|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10869404|NCT00407485|EG000|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10869405|NCT00407511|BG000|Baseline|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
10869406|NCT00407511|FG000|Participant Flow|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
10869407|NCT00407511|OG000|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
10869408|NCT00407511|EG000|Reported Event|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
10869409|NCT00407537|BG000|Baseline|Caduet as Assigned|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
10869410|NCT00407537|BG001|Baseline|Usual Care as Assigned|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
10869411|NCT00407537|BG002|Baseline|Total|Total of all reporting groups
10869412|NCT00407537|FG000|Participant Flow|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
10869413|NCT00407537|FG001|Participant Flow|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
10869414|NCT00407537|OG000|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
10869415|NCT00407537|OG001|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
10869416|NCT00407537|EG000|Reported Event|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
10869417|NCT00407537|EG001|Reported Event|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
10869418|NCT00407550|BG000|Baseline|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
10869419|NCT00407550|BG001|Baseline|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
10869420|NCT00407550|BG002|Baseline|Total|Total of all reporting groups
10869421|NCT00407550|FG000|Participant Flow|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
10869422|NCT00407550|FG001|Participant Flow|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
10869423|NCT00407550|OG000|Outcome|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
10869424|NCT00407550|OG001|Outcome|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
10869425|NCT00407550|EG000|Reported Event|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
10869426|NCT00407550|EG001|Reported Event|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
10869427|NCT00407563|BG000|Baseline|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
10869428|NCT00407563|FG000|Participant Flow|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
10869429|NCT00407563|OG000|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
10869430|NCT00407563|EG000|Reported Event|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
10869431|NCT00407654|BG000|Baseline|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10869432|NCT00407654|FG000|Participant Flow|VEGF Trap IV Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10869433|NCT00407654|OG000|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10869434|NCT00407654|OG000|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
10869435|NCT00407654|EG000|Reported Event|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10869436|NCT00407745|BG000|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
10869437|NCT00407745|BG001|Baseline|Placebo|Placebo matching study treatment.
10869438|NCT00407745|BG002|Baseline|Total|Total of all reporting groups
10869439|NCT00407745|FG000|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
10869440|NCT00407745|FG001|Participant Flow|Placebo|Placebo matching study treatment.
10869441|NCT00407745|OG000|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
10869442|NCT00407745|OG001|Outcome|Placebo|Placebo matching study treatment.
11348779|NCT04124536|OG000|Outcome|HIV-Positive Intervention|"Combination strategy for partner HIV testing~HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm."
11348780|NCT04124536|OG001|Outcome|HIV-Positive Control|"Single strategy for partner HIV testing~Standard partner notification services."
10869443|NCT00407745|EG000|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
10869444|NCT00407745|EG001|Reported Event|Placebo|Placebo matching study treatment.
10869445|NCT00407758|BG000|Baseline|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
10869446|NCT00407758|FG000|Participant Flow|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
10869447|NCT00407758|OG000|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
10869448|NCT00407758|EG000|Reported Event|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
10869449|NCT00407797|BG000|Baseline|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
10869450|NCT00407797|FG000|Participant Flow|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
10869451|NCT00407797|OG000|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
10869452|NCT00407797|EG000|Reported Event|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
10869453|NCT00407888|BG000|Baseline|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
10869454|NCT00407888|FG000|Participant Flow|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
10869455|NCT00407888|OG000|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
10869456|NCT00407888|EG000|Reported Event|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
10869457|NCT00407966|BG000|Baseline|Arm A|Flavopiridol, ara-C, mitoxantrone
10869458|NCT00407966|FG000|Participant Flow|Arm A|Flavopiridol, ara-C, mitoxantrone
10869459|NCT00407966|OG000|Outcome|Arm A|Flavopiridol, ara-C, mitoxantrone
10869460|NCT00407966|EG000|Reported Event|Arm A|Flavopiridol, ara-C, mitoxantrone
11348781|NCT04124536|OG002|Outcome|HIV-Negative Intervention|"Combination strategy for partner HIV testing~HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm."
10869461|NCT00408070|BG000|Baseline|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
10869462|NCT00408070|FG000|Participant Flow|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
10869463|NCT00408070|OG000|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
10869464|NCT00408070|EG000|Reported Event|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
10869465|NCT00408200|BG000|Baseline|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
10869466|NCT00408200|BG001|Baseline|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
10869467|NCT00408200|BG002|Baseline|Total|Total of all reporting groups
10869468|NCT00408200|FG000|Participant Flow|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
10869469|NCT00408200|FG001|Participant Flow|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
10869470|NCT00408200|OG000|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
10869471|NCT00408200|OG001|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
10869472|NCT00408200|EG000|Reported Event|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
10869473|NCT00408200|EG001|Reported Event|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
10869474|NCT00408317|BG000|Baseline|Entire Study Population|Includes all participants who received Ultrase® MT20 first and placebo first.
10869475|NCT00408317|FG000|Participant Flow|Ultrase® MT20 First, Then Placebo|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the first intervention period followed by placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
10869476|NCT00408317|FG001|Participant Flow|Placebo First, Then Ultrase®MT20|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the first intervention period followed by Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
10869477|NCT00408317|OG000|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
10869478|NCT00408317|OG001|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
10869479|NCT00408317|EG000|Reported Event|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion,for 6 to 7 days in either first intervention period or second intervention period.
10869480|NCT00408317|EG001|Reported Event|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
10869481|NCT00408408|BG000|Baseline|Docetaxel Then AC|Docetaxel then AC
10869482|NCT00408408|BG001|Baseline|Docetaxel + Bev Then AC + Bev|Docetaxel + Bev then AC + Bev
10869483|NCT00408408|BG002|Baseline|Docetaxel + Capecitabine Then AC|Docetaxel + Capecitabine then AC
10869484|NCT00408408|BG003|Baseline|Docetaxel + Cape + Bev Then AC + Bev|Docetaxel + Cape + Bev then AC + Bev
10869485|NCT00408408|BG004|Baseline|Docetaxel + Gem Then AC|Docetaxel + Gem then AC
10869486|NCT00408408|BG005|Baseline|Docetaxel + Gem + Bev Then AC + Bev|Docetaxel + Gem + Bev then AC + Bev
10869487|NCT00408408|BG006|Baseline|Total|Total of all reporting groups
10869488|NCT00408408|FG000|Participant Flow|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
10869489|NCT00408408|FG001|Participant Flow|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
10869490|NCT00408408|FG002|Participant Flow|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
10869491|NCT00408408|FG003|Participant Flow|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
10869492|NCT00408408|FG004|Participant Flow|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
10869493|NCT00408408|FG005|Participant Flow|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
10869494|NCT00408408|OG000|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
10869495|NCT00408408|OG001|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
10869496|NCT00408408|OG002|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
10869497|NCT00408408|OG003|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
10869498|NCT00408408|OG004|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
10869499|NCT00408408|OG005|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
10869500|NCT00408408|EG000|Reported Event|Docetaxel Then AC|Docetaxel then AC
10869501|NCT00408408|EG001|Reported Event|Docetaxel + Bev Then AC + Bev|Docetaxel + Bev then AC + Bev
10869502|NCT00408408|EG002|Reported Event|Docetaxel + Capecitabine Then AC|Docetaxel + Capecitabine then AC
10869503|NCT00408408|EG003|Reported Event|Docetaxel + Cape + Bev Then AC + Bev|Docetaxel + Cape + Bev then AC + Bev
10869504|NCT00408408|EG004|Reported Event|Docetaxel + Gem Then AC|Docetaxel + Gem then AC
10869505|NCT00408408|EG005|Reported Event|Docetaxel + Gem + Bev Then AC + Bev|Docetaxel + Gem + Bev then AC + Bev
10869506|NCT00408421|BG000|Baseline|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
10869507|NCT00408421|BG001|Baseline|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
10869508|NCT00408421|BG002|Baseline|Total|Total of all reporting groups
10869509|NCT00408421|FG000|Participant Flow|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
10869510|NCT00408421|FG001|Participant Flow|Duloxetine 60 mg|Patients randomly assigned to duloxetine 60 mg daily (QD) started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning at Week 7, patients on duloxetine 60 mg QD were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD.
10869511|NCT00408421|FG002|Participant Flow|Duloxetine 120 mg|Beginning at Week 7, patients receiving duloxetine 60 mg daily (QD) were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD
10869512|NCT00408421|OG000|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
10869513|NCT00408421|OG001|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
10869514|NCT00408421|OG000|Outcome|Group 2 - Duloxetine 60mg|
10869515|NCT00408421|OG001|Outcome|Group 3 - Duloxetine 120mg|
10869516|NCT00408421|EG000|Reported Event|Placebo|Placebo
10869517|NCT00408421|EG001|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
10869518|NCT00408434|BG000|Baseline|CS-7017 0.10 mg|Participants who received oral CS-7017 0.10 mg every 12 hours.
10869519|NCT00408434|BG001|Baseline|CS-7017 0.15 mg|Participants who received oral CS-7017 0.15 mg every 12 hours.
10869520|NCT00408434|BG002|Baseline|CS-7017 0.25 mg|Participants who received oral CS-7017 0.25 mg every 12 hours.
10869521|NCT00408434|BG003|Baseline|CS-7017 0.35 mg|Participants who received oral CS-7017 0.35 mg every 12 hours.
10869522|NCT00408434|BG004|Baseline|CS-7017 0.50 mg|Participants who received oral CS-7017 0.50 mg every 12 hours.
10869523|NCT00408434|BG005|Baseline|CS-7017 0.75 mg|Participants who received oral CS-7017 0.75 mg every 12 hours.
10869524|NCT00408434|BG006|Baseline|CS-7017 1.15 mg|Participants who received oral CS-7017 1.15 mg every 12 hours.
10869525|NCT00408434|BG007|Baseline|Total|Total of all reporting groups
10869526|NCT00408434|FG000|Participant Flow|CS-7017 0.10 mg|Participants who received oral CS-7017 0.10 mg every 12 hours.
10869527|NCT00408434|FG001|Participant Flow|CS-7017 0.15 mg|Participants who received oral CS-7017 0.15 mg every 12 hours.
10869528|NCT00408434|FG002|Participant Flow|CS-7017 0.25 mg|Participants who received oral CS-7017 0.25 mg every 12 hours.
10869529|NCT00408434|FG003|Participant Flow|CS-7017 0.35 mg|Participants who received oral CS-7017 0.35 mg every 12 hours.
10869530|NCT00408434|FG004|Participant Flow|CS-7017 0.50 mg|Participants who received oral CS-7017 0.50 mg every 12 hours.
10869531|NCT00408434|FG005|Participant Flow|CS-7017 0.75 mg|Participants who received oral CS-7017 0.75 mg every 12 hours.
10869532|NCT00408434|FG006|Participant Flow|CS-7017 1.15 mg|Participants who received oral CS-7017 1.15 mg every 12 hours.
10869533|NCT00408434|OG000|Outcome|CS-7017 0.10 mg|Participants who received oral CS-7017 0.10 mg every 12 hours.
10869534|NCT00408434|OG001|Outcome|CS-7017 0.15 mg|Participants who received oral CS-7017 0.15 mg every 12 hours.
10869535|NCT00408434|OG002|Outcome|CS-7017 0.25 mg|Participants who received oral CS-7017 0.25 mg every 12 hours.
10869536|NCT00408434|OG003|Outcome|CS-7017 0.35 mg|Participants who received oral CS-7017 0.35 mg every 12 hours.
10869537|NCT00408434|OG004|Outcome|CS-7017 0.50 mg|Participants who received oral CS-7017 0.50 mg every 12 hours.
10869538|NCT00408434|OG005|Outcome|CS-7017 0.75 mg|Participants who received oral CS-7017 0.75 mg every 12 hours.
10869539|NCT00408434|OG006|Outcome|CS-7017 1.15 mg|Participants who received oral CS-7017 1.15 mg every 12 hours.
10869540|NCT00408434|OG007|Outcome|CS-7017 All Participants|All participants who received CS-7017 with doses ranging from 0.10 mg to 1.15 mg every 12 hours.
10869541|NCT00408434|EG000|Reported Event|CS-7017 0.10 mg|Participants who received oral CS-7017 0.10 mg every 12 hours.
10869542|NCT00408434|EG001|Reported Event|CS-7017 0.15 mg|Participants who received oral CS-7017 0.15 mg every 12 hours.
10869543|NCT00408434|EG002|Reported Event|CS-7017 0.25 mg|Participants who received oral CS-7017 0.25 mg every 12 hours.
10869544|NCT00408434|EG003|Reported Event|CS-7017 0.35 mg|Participants who received oral CS-7017 0.35 mg every 12 hours.
10869545|NCT00408434|EG004|Reported Event|CS-7017 0.50 mg|Participants who received oral CS-7017 0.50 mg every 12 hours.
10869546|NCT00408434|EG005|Reported Event|CS-7017 0.75 mg|Participants who received oral CS-7017 0.75 mg every 12 hours.
10869547|NCT00408434|EG006|Reported Event|CS-7017 1.15 mg|Participants who received oral CS-7017 1.15 mg every 12 hours.
10869548|NCT00408460|BG000|Baseline|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
10869549|NCT00408460|FG000|Participant Flow|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
10869550|NCT00408460|OG000|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
10869551|NCT00408460|EG000|Reported Event|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
10869552|NCT00408499|BG000|Baseline|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
10869553|NCT00408499|FG000|Participant Flow|Dose Level 1|100 mg Erlotinib, 150 mg/m2 Cetuximab
10869554|NCT00408499|FG001|Participant Flow|Dose Level 2|100 mg Erlotinib, 200 mg/m2 Cetuximab
10869555|NCT00408499|FG002|Participant Flow|Dose Level 3|100 mg Erlotinib, 250 mg/m2 Cetuximab
10869556|NCT00408499|FG003|Participant Flow|Dose Level 4|150 mg Erlotinib, 250 mg/m2 Cetuximab
10869557|NCT00408499|FG004|Participant Flow|Phase II- Dose Expansion|Phase II dose expansion at determined MTD
10869558|NCT00408499|OG000|Outcome|Dose Level 1|100 mg Erlotinib, 150 mg/m2 Cetuximab
10869559|NCT00408499|OG001|Outcome|Dose Level 2|100 mg Erlotinib, 200 mg/m2 Cetuximab
11348782|NCT04124536|OG003|Outcome|HIV-Negative Control|"Single strategy for partner HIV testing~Partner notification services adapted for partners of HIV-negative women."
10869560|NCT00408499|OG002|Outcome|Dose Level 3|100 mg Erlotinib, 250 mg/m2 Cetuximab
10869561|NCT00408499|OG003|Outcome|Dose Level 4|150 mg Erlotinib, 250 mg/m2 Cetuximab
10869562|NCT00408499|OG000|Outcome|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
10869563|NCT00408499|OG000|Outcome|Phase II Expansion|44 Patients at dose level 4 phase II expansion: 150 mg Erlotinib, 250 mg/m2 Cetuximab
10869564|NCT00408499|EG000|Reported Event|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
10869565|NCT00408564|BG000|Baseline|Gemcitabine,Oxaliplatin and Cetuximab|"Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.~After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks."
10869566|NCT00408564|FG000|Participant Flow|Gemcitabine,Oxaliplatin and Cetuximab|"Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.~After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.~cetuximab~capecitabine~oxaliplatin~conventional surgery~neoadjuvant therapy~radiation therapy~Gemcitabine"
10869567|NCT00408564|OG000|Outcome|Gemcitabine,Oxaliplatin and Cetuximab|"Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.~After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks."
10869568|NCT00408564|OG000|Outcome|Gemcitabine,Oxaliplatin and Cetuximab|"Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.~After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.~cetuximab~capecitabine~oxaliplatin~conventional surgery~neoadjuvant therapy~radiation therapy~Gemcitabine"
11348783|NCT04124536|OG000|Outcome|Healthcare Workers|Healthcare workers who participated in in-depth interviews were involved in different aspects of male partner HIV testing and included study staff members.
10869569|NCT00408564|EG000|Reported Event|Gemcitabine,Oxaliplatin and Cetuximab|"Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.~After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks."
10869570|NCT00408590|BG000|Baseline|Cohort 1|Includes all dose levels of Cohort 1
10869571|NCT00408590|BG001|Baseline|Cohort 2|Includes all dose levels of Cohort 2
10869572|NCT00408590|BG002|Baseline|Total|Total of all reporting groups
10869573|NCT00408590|FG000|Participant Flow|Cohort 1, Dose Level 1|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 1, these patients received a 10^3 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869574|NCT00408590|FG001|Participant Flow|Cohort 1, Dose Level 2|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 2, these patients received a 10^4 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869575|NCT00408590|FG002|Participant Flow|Cohort 1, Dose Level 3|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869576|NCT00408590|FG003|Participant Flow|Cohort 1, Dose Level 4|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869577|NCT00408590|FG004|Participant Flow|Cohort 1, Dose Level 5|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869578|NCT00408590|FG005|Participant Flow|Cohort 1, Dose Level 6|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869579|NCT00408590|FG006|Participant Flow|Cohort 1, Dose Level 7|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869580|NCT00408590|FG007|Participant Flow|Cohort 2, Dose Level 1|Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
10869581|NCT00408590|FG008|Participant Flow|Cohort 2, Dose Level 2|Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
10869582|NCT00408590|OG000|Outcome|Cohort 1|Includes all dose levels of Cohort 1
10869583|NCT00408590|OG001|Outcome|Cohort 2|Includes all dose levels of Cohort 2
10869584|NCT00408590|OG000|Outcome|Cohort 1, Dose Level 1|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 1, these patients received a 10^3 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869585|NCT00408590|OG001|Outcome|Cohort 1, Dose Level 2|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 2, these patients received a 10^4 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869586|NCT00408590|OG002|Outcome|Cohort 1, Dose Level 3|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869587|NCT00408590|OG003|Outcome|Cohort 1, Dose Level 4|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869588|NCT00408590|OG004|Outcome|Cohort 1, Dose Level 5|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869589|NCT00408590|OG005|Outcome|Cohort 1, Dose Level 6|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869590|NCT00408590|OG006|Outcome|Cohort 1, Dose Level 7|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
10869591|NCT00408590|OG007|Outcome|Cohort 2, Dose Level 1|Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
10869592|NCT00408590|OG008|Outcome|Cohort 2, Dose Level 2|Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
10869593|NCT00408590|EG000|Reported Event|Cohort 1|Includes all dose levels of Cohort 1
10869594|NCT00408590|EG001|Reported Event|Cohort 2|Includes all dose levels of Cohort 2
10869595|NCT00408603|BG000|Baseline|48 mg/m2|48 mg/m2 every 21 days
10869596|NCT00408603|BG001|Baseline|60 mg/m2|60 mg/m2 every 28 days
10869597|NCT00408603|BG002|Baseline|75 mg/m2|75 mg/m2 every 28 days
10869598|NCT00408603|BG003|Baseline|Total|Total of all reporting groups
10869599|NCT00408603|FG000|Participant Flow|Stage 48 mg/m2|"All Stage 1 patients will receive voreloxin injection~Voreloxin Injection: All Stage 1 patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles."
10869600|NCT00408603|FG001|Participant Flow|Stage 60 mg/m2|Following safety of 48 mg/m2 group, next Stagel is 60mg/m2 at 28 day periods up to 6 cycles.
10869601|NCT00408603|FG002|Participant Flow|Stage 75 mg/m2|Following safety of 60 mg/m2 group, next Stage is 75 mg/m2 at 28 day periods up to 6 cycles.
10869602|NCT00408603|OG000|Outcome|48 mg/m2|48 mg/m2 every 21 days
10869603|NCT00408603|OG001|Outcome|60 mg/m2|60 mg/m2 every 28 days
10869604|NCT00408603|OG002|Outcome|75 mg/m2|75 mg/m2 every 28 days
10869605|NCT00408603|OG003|Outcome|Total|Overall
10869606|NCT00408603|EG000|Reported Event|48 mg/m2|48 mg/m2 every 21 days
10869607|NCT00408603|EG001|Reported Event|60 mg/m2|60 mg/m2 every 28 days
10869608|NCT00408603|EG002|Reported Event|75 mg/m2|75 mg/m2 every 28 days
10869609|NCT00408603|EG003|Reported Event|Total|Overall
10869610|NCT00408629|BG000|Baseline|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
10869611|NCT00408629|BG001|Baseline|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
10869612|NCT00408629|BG002|Baseline|Total|Total of all reporting groups
10869613|NCT00408629|FG000|Participant Flow|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
10869614|NCT00408629|FG001|Participant Flow|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
10869615|NCT00408629|OG000|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
10869616|NCT00408629|OG001|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
10869617|NCT00408629|EG000|Reported Event|Adalimumab Group - Double-Blind Period|During the Double-Blind period, the Adalimumab treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
10869618|NCT00408629|EG001|Reported Event|Placebo Group - Double-Blind Period|The placebo treatment group received placebo throughout the Double-Blind period.
10869619|NCT00408629|EG002|Reported Event|Any Adalimumab|During the Double-Blind period, only the Adalimumab treatment group received active study drug (dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 [160/80/40 mg]). After the switch to open-label treatment, participants in both treatment groups received adalimumab 40 mg eow, unless they dose-escalated, in which case they received adalimumab 40 mg every week (ew). Consequently, this analysis set combined adalimumab exposure from both the Double-Blind and Open-Label periods.
10869620|NCT00408681|BG000|Baseline|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
10869621|NCT00408681|FG000|Participant Flow|Treated Patients|Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
10869622|NCT00408681|OG000|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
10869623|NCT00408681|OG000|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
10869624|NCT00408681|EG000|Reported Event|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
10869625|NCT00408694|BG000|Baseline|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
10869626|NCT00408694|FG000|Participant Flow|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
11007033|NCT01089127|BG004|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
10869627|NCT00408694|OG000|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
10869628|NCT00408694|EG000|Reported Event|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients."
10869629|NCT00408876|BG000|Baseline|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
10869630|NCT00408876|BG001|Baseline|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
10869631|NCT00408876|BG002|Baseline|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
10869632|NCT00408876|BG003|Baseline|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
10869633|NCT00408876|BG004|Baseline|Total|Total of all reporting groups
10869634|NCT00408876|FG000|Participant Flow|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
10869635|NCT00408876|FG001|Participant Flow|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
10869636|NCT00408876|FG002|Participant Flow|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
10869637|NCT00408876|FG003|Participant Flow|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
10869638|NCT00408876|OG000|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
10869639|NCT00408876|OG001|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
10869640|NCT00408876|OG002|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
11348784|NCT04124536|EG000|Reported Event|HIV-Positive Intervention|"Combination strategy for partner HIV testing~HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm."
10869641|NCT00408876|OG003|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
10869642|NCT00408876|EG000|Reported Event|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
10869643|NCT00408876|EG001|Reported Event|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
10869644|NCT00408876|EG002|Reported Event|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
10869645|NCT00408876|EG003|Reported Event|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
10869646|NCT00408902|BG000|Baseline|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10869647|NCT00408902|FG000|Participant Flow|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10869648|NCT00408902|OG000|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10869649|NCT00408902|OG000|Outcome|TandutinibTreatment|"Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally, 500 mg bid daily~laboratory biomarker analysis: Correlative studies"
10869650|NCT00408902|EG000|Reported Event|TandutinibTreatment|"Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~laboratory biomarker analysis: Correlative studies"
10869651|NCT00408928|BG000|Baseline|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
10869652|NCT00408928|FG000|Participant Flow|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
10869653|NCT00408928|OG000|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
10869654|NCT00408928|EG000|Reported Event|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
10869655|NCT00408993|BG000|Baseline|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
10869656|NCT00408993|BG001|Baseline|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
10869657|NCT00408993|BG002|Baseline|Total|Total of all reporting groups
10869658|NCT00408993|FG000|Participant Flow|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
10869659|NCT00408993|FG001|Participant Flow|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
10869660|NCT00408993|OG000|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
10869661|NCT00408993|OG001|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
10869662|NCT00408993|OG000|Outcome|Duloxetine - Morning Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
10869663|NCT00408993|OG001|Outcome|Duloxetine - Evening Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
10869664|NCT00408993|OG002|Outcome|Placebo - Morning Dosing|Placebo QD, PO for 12 weeks
10869665|NCT00408993|OG003|Outcome|Placebo - Evening Dosing|Placebo QD, PO for 12 weeks
10869666|NCT00408993|EG000|Reported Event|Placebo|Placebo
11098883|NCT01578577|FG001|Participant Flow|EHMI|"Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.~EHMI: The EHMI intervention consists of multiple components, all leveraged by the Epic EHR platform (Verona, WI). The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides"
10869667|NCT00408993|EG001|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
10869668|NCT00409006|BG000|Baseline|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
10869669|NCT00409006|BG001|Baseline|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
10869670|NCT00409006|BG002|Baseline|Total|Total of all reporting groups
10869671|NCT00409006|FG000|Participant Flow|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
10869672|NCT00409006|FG001|Participant Flow|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
10869673|NCT00409006|OG000|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
10869674|NCT00409006|OG001|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
10869675|NCT00409006|EG000|Reported Event|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
10869676|NCT00409006|EG001|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
10869677|NCT00409175|BG000|Baseline|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
10869678|NCT00409175|BG001|Baseline|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
10869679|NCT00409175|BG002|Baseline|Total|Total of all reporting groups
10869680|NCT00409175|FG000|Participant Flow|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
10869681|NCT00409175|FG001|Participant Flow|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
10869682|NCT00409175|OG000|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
10869683|NCT00409175|OG001|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
10869684|NCT00409175|EG000|Reported Event|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
10869685|NCT00409175|EG001|Reported Event|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
10869686|NCT00409188|BG000|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
10869687|NCT00409188|BG001|Baseline|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
10869688|NCT00409188|BG002|Baseline|Total|Total of all reporting groups
10869689|NCT00409188|FG000|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
10869690|NCT00409188|FG001|Participant Flow|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
10869691|NCT00409188|OG000|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
10869692|NCT00409188|OG001|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
10869693|NCT00409188|EG000|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
10869694|NCT00409188|EG001|Reported Event|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
10869695|NCT00409240|BG000|Baseline|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
10869696|NCT00409240|BG001|Baseline|Usual Care|Patient continued on usual care
10869697|NCT00409240|BG002|Baseline|Total|Total of all reporting groups
10869698|NCT00409240|FG000|Participant Flow|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
10869699|NCT00409240|FG001|Participant Flow|Usual Care|Patient continued on usual care
10869700|NCT00409240|OG000|Outcome|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
10869701|NCT00409240|OG001|Outcome|Usual Care|Patient continued on usual care
10869702|NCT00409240|EG000|Reported Event|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
10869703|NCT00409240|EG001|Reported Event|Usual Care|Patient continued on usual care
10869704|NCT00409292|BG000|Baseline|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
10869705|NCT00409292|FG000|Participant Flow|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.~Four weeks of study drug was considered to be one cycle of treatment."
10869706|NCT00409292|OG000|Outcome|RAD001|RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
10869707|NCT00409292|OG000|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
10869708|NCT00409292|OG000|Outcome|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.~Four weeks of study drug was considered to be one cycle of treatment.~RAD001: Taken orally daily for as long as the participant continues to receive a benefit."
10869709|NCT00409292|EG000|Reported Event|RAD001|
10869710|NCT00409409|BG000|Baseline|300 IR|300 IR grass pollen allergen extract tablet
10869711|NCT00409409|BG001|Baseline|Placebo|Placebo tablet
10869712|NCT00409409|BG002|Baseline|Total|Total of all reporting groups
10869713|NCT00409409|FG000|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
10869714|NCT00409409|FG001|Participant Flow|Placebo|Placebo tablet
10869715|NCT00409409|OG000|Outcome|300 IR|300 IR grass pollen allergen extract tablet
11348785|NCT04124536|EG001|Reported Event|HIV-Positive Control|"Single strategy for partner HIV testing~Standard partner notification services."
10869716|NCT00409409|OG001|Outcome|Placebo|Placebo tablet
10869717|NCT00409409|EG000|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
10869718|NCT00409409|EG001|Reported Event|Placebo|Placebo tablet
10869719|NCT00409539|BG000|Baseline|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
10869720|NCT00409539|BG001|Baseline|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869721|NCT00409539|BG002|Baseline|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869722|NCT00409539|BG003|Baseline|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869723|NCT00409539|BG004|Baseline|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869724|NCT00409539|BG005|Baseline|Total|Total of all reporting groups
10869725|NCT00409539|FG000|Participant Flow|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
10869726|NCT00409539|FG001|Participant Flow|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869727|NCT00409539|FG002|Participant Flow|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869728|NCT00409539|FG003|Participant Flow|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869729|NCT00409539|FG004|Participant Flow|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869730|NCT00409539|OG000|Outcome|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
10869731|NCT00409539|OG001|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869732|NCT00409539|OG002|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869733|NCT00409539|OG003|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869734|NCT00409539|OG004|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869735|NCT00409539|EG000|Reported Event|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
10869736|NCT00409539|EG001|Reported Event|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869737|NCT00409539|EG002|Reported Event|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869738|NCT00409539|EG003|Reported Event|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869739|NCT00409539|EG004|Reported Event|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
10869740|NCT00409565|BG000|Baseline|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
10869741|NCT00409565|FG000|Participant Flow|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
10869742|NCT00409565|OG000|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
10869743|NCT00409565|EG000|Reported Event|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
10869744|NCT00409578|BG000|Baseline|Placebo|Placebo tablets and capsules
10869745|NCT00409578|BG001|Baseline|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
10869746|NCT00409578|BG002|Baseline|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
10869747|NCT00409578|BG003|Baseline|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
10869748|NCT00409578|BG004|Baseline|Total|Total of all reporting groups
11098884|NCT01578577|FG002|Participant Flow|Nurse Educator + EHMI|Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.
11098885|NCT01578577|OG000|Outcome|Standard Care|This arm will serve as a control group and will not receive any intervention.
11098886|NCT01578577|OG001|Outcome|EHMI|Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.
11098887|NCT01578577|OG002|Outcome|Nurse Educator + EHMI|Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.
11098888|NCT01578577|OG001|Outcome|EHMI|EHMI: The EHMI intervention consists of multiple components. The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides
11098889|NCT01578577|OG000|Outcome|Standard Care Likely Limited Health Literacy|This arm will serve as a control group and will not receive any intervention.
10869749|NCT00409578|FG000|Participant Flow|Placebo|Placebo tablets and capsules
10869750|NCT00409578|FG001|Participant Flow|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
10869751|NCT00409578|FG002|Participant Flow|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
10869752|NCT00409578|FG003|Participant Flow|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
10869753|NCT00409578|OG000|Outcome|Placebo|Placebo tablets and capsules
10869754|NCT00409578|OG001|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
10869755|NCT00409578|OG002|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
11098890|NCT01578577|OG001|Outcome|EHMI Likely Limited Health Literacy|EHMI: The EHMI intervention consists of multiple components. The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides
11098891|NCT01578577|OG002|Outcome|Nurse Educator + EHMI Likely Limted Health Literacy|Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.
11098892|NCT01578577|OG003|Outcome|Standard Care Possibly Limited Health Literacy|Standard Care Possibly Limited Health Literacy
11098893|NCT01578577|OG004|Outcome|EHMI Possibly Limited Health Literacy|EHMI Possibly Limited Health Literacy
11098894|NCT01578577|OG005|Outcome|Nurse Educator + EHMI Possibly Limited Health Literacy|
11098895|NCT01578577|OG006|Outcome|Standard Care Likely Adequate Health Literacy|Standard Care Likely Adequate Health Literacy
11098896|NCT01578577|OG007|Outcome|EHMI Likely Adequate Health Literacy|EHMI Likely Adequate Health Literacy
11098897|NCT01578577|OG008|Outcome|Nurse Educator + EHMI Likely Adequate Health Literacy|Nurse Educator + EHMI Likely Adequate Health Literacy
10869756|NCT00409578|OG003|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
10869757|NCT00409578|EG000|Reported Event|Placebo|Placebo tablets and capsules
10869758|NCT00409578|EG001|Reported Event|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
10869759|NCT00409578|EG002|Reported Event|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
10869760|NCT00409578|EG003|Reported Event|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
10869761|NCT00409617|BG000|Baseline|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
10869762|NCT00409617|FG000|Participant Flow|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
10869763|NCT00409617|OG000|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
10869764|NCT00409617|EG000|Reported Event|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
10869765|NCT00409682|BG000|Baseline|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
10869766|NCT00409682|BG001|Baseline|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
10869767|NCT00409682|BG002|Baseline|Low-Dose Adalimumab: 20 mg or 10 mg (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
10869768|NCT00409682|BG003|Baseline|Total|Total of all reporting groups
10869769|NCT00409682|FG000|Participant Flow|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing ≥ 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing < 40 kg at Baseline received 80 mg at Week 0 and 40 mg at Week 2.
10869770|NCT00409682|FG001|Participant Flow|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 10 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
11098898|NCT01578577|EG000|Reported Event|Standard Care|This arm will serve as a control group and will not receive any intervention.
10869771|NCT00409682|FG002|Participant Flow|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 20 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
10869772|NCT00409682|OG000|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
10869773|NCT00409682|OG001|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
10869774|NCT00409682|EG000|Reported Event|Open-label Adalimumab (Week 0 to Week 4)|
10869775|NCT00409682|EG001|Reported Event|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|
10869776|NCT00409682|EG002|Reported Event|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|
10869777|NCT00409708|BG000|Baseline|Ritalin LA Plus Behavior Therapy|10-60 mg/day
10869778|NCT00409708|BG001|Baseline|Behavior Therapy|0 mg/day Ritalin LA
10869779|NCT00409708|BG002|Baseline|Total|Total of all reporting groups
10869780|NCT00409708|FG000|Participant Flow|Ritalin LA Plus Behavior Therapy|10-60 mg/day
10869781|NCT00409708|FG001|Participant Flow|Behavior Therapy|0 mg/day Ritalin LA
10869782|NCT00409708|OG000|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
10869783|NCT00409708|OG001|Outcome|Behavior Therapy|0 mg/day Ritalin LA
10869784|NCT00409708|EG000|Reported Event|Ritalin+Behavior|Ritalin+Behavior
10869785|NCT00409708|EG001|Reported Event|Behavior|Behavior
10869786|NCT00409747|BG000|Baseline|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
10869787|NCT00409747|FG000|Participant Flow|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
10869788|NCT00409747|OG000|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
10869789|NCT00409747|EG000|Reported Event|Overall Study/Minocycline|
10869790|NCT00409786|BG000|Baseline|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
10869791|NCT00409786|FG000|Participant Flow|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
10869792|NCT00409786|OG000|Outcome|Group 1|All participants
10869793|NCT00409786|EG000|Reported Event|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
10869794|NCT00409825|BG000|Baseline|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.~AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
10869795|NCT00409825|FG000|Participant Flow|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.~AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
10869796|NCT00409825|OG000|Outcome|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.
10869797|NCT00409825|EG000|Reported Event|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 4, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 3: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.
10869798|NCT00409838|BG000|Baseline|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
10869799|NCT00409838|BG001|Baseline|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
10869800|NCT00409838|BG002|Baseline|Total|Total of all reporting groups
10869801|NCT00409838|FG000|Participant Flow|Abatacept, 10 mg/kg|"Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).~Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg."
10869802|NCT00409838|FG001|Participant Flow|Placebo|Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).
10869803|NCT00409838|OG000|Outcome|Abatacept, 10 mg/kg|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
10869804|NCT00409838|OG001|Outcome|Placebo|Participants received placebo IV on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
10869805|NCT00409838|OG000|Outcome|Abatacept|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
10869806|NCT00409838|OG001|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
10869807|NCT00409838|OG000|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
10869808|NCT00409838|OG001|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
10869809|NCT00409838|OG000|Outcome|Abatacept 500 mg|
10869810|NCT00409838|OG001|Outcome|Abatacept 750 mg|
10869811|NCT00409838|OG002|Outcome|Abatacept 500 mg and 750 mg|
10869812|NCT00409838|OG000|Outcome|Abatacept + Background Methotrexate|Dosage: 500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
10869813|NCT00409838|OG000|Outcome|All Treated|Abatacept, administered intravenously IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months in the LTE period on a background of methotrexate
10869814|NCT00409838|OG000|Outcome|All Treated|Abatacept was administered intravenously monthly at a fixed dose of approximately 10 mg/kg in the LTE period on a background of methotrexate
10869815|NCT00409838|OG000|Outcome|Abatacept, 10 mg/kg|Short-term Period: Abatacept administered IV in a body-weight tiered dose approximating 10 mg/kg. Study medication was administered on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
10869816|NCT00409838|OG001|Outcome|Placebo|Short-term Period: Placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
10869817|NCT00409838|OG000|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
10869818|NCT00409838|OG001|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
10869819|NCT00409838|OG001|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
10869820|NCT00409838|OG001|Outcome|Placebo|Short-term Period: Participants received placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
10869821|NCT00409838|OG001|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
10869822|NCT00409838|EG000|Reported Event|Abatacept 10 mg/kg|500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
10869823|NCT00409838|EG001|Reported Event|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
10869824|NCT00410046|BG000|Baseline|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
11348786|NCT04124536|EG002|Reported Event|HIV-Negative Intervention|"Combination strategy for partner HIV testing~HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm."
10869825|NCT00410046|FG000|Participant Flow|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
10869826|NCT00410046|OG000|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
10869827|NCT00410046|OG001|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
10869828|NCT00410046|EG000|Reported Event|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
10869829|NCT00410059|BG000|Baseline|Erlotinib|150 mg orally day for 28 days.
10869830|NCT00410059|FG000|Participant Flow|Erlotinib|150 mg orally day for 28 days.
10869831|NCT00410059|OG000|Outcome|Erlotinib|150 mg orally day for 28 days.
10869832|NCT00410059|EG000|Reported Event|Erlotinib|150 mg orally day for 28 days.
10869833|NCT00410072|BG000|Baseline|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
10869834|NCT00410072|BG001|Baseline|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
10869835|NCT00410072|BG002|Baseline|Total|Total of all reporting groups
10869836|NCT00410072|FG000|Participant Flow|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
10869837|NCT00410072|FG001|Participant Flow|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
10869838|NCT00410072|OG000|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
10869839|NCT00410072|OG001|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
10869840|NCT00410072|EG000|Reported Event|ETV 0.5 mg|ETV 0.5 mg monotherapy given QD for 100 weeks
10869841|NCT00410072|EG001|Reported Event|ETV/TDF 0.5 mg +TDF 300 mg|ETV 0.5 mg plus TDF 300 mg combination therapy given once daily (QD) for 100 weeks
10869842|NCT00410124|BG000|Baseline|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
10869843|NCT00410124|BG001|Baseline|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
10869844|NCT00410124|BG002|Baseline|Total|Total of all reporting groups
10869845|NCT00410124|FG000|Participant Flow|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
10869846|NCT00410124|FG001|Participant Flow|Placebo + BSC / RAD001|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
10869847|NCT00410124|OG000|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
10869848|NCT00410124|OG001|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
10869849|NCT00410124|OG000|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
10869850|NCT00410124|OG001|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
10869851|NCT00410124|OG000|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
10869852|NCT00410124|EG000|Reported Event|Randomized to RAD001+ BSC ( Blinded + Open Label)|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
10869853|NCT00410124|EG001|Reported Event|Randomized to Placebo + BSC (Open Label)|With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
10869854|NCT00410124|EG002|Reported Event|Randomized to Placebo + BSC (Double Blind Only)|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care.
10879203|NCT00456014|FG000|Participant Flow|Open Standardized Treatment|"Participants will take escitalopram through standardized dosing over an 8 week trial. Non-remitters will be offered entry into a second open treatment phase with standardized treatment with desipramine.~In phase 1, participants will receive escitalopram beginning at 10mg daily for 4 weeks, increasing to 20mg if non-response at week 4 or 6. If participants experience intolerable side-effects, they will be switched to an alternative SSRI, sertraline. Non-remitters after 8 weeks may enter a second phase of standardized treatment, switching from escitalopram to desipramine, dosed by blood level according to a treatment protocol. Those with intolerable side-effects to desipramine will be switched to an alternative tricyclic antidepressant, nortriptyline."
10879204|NCT00456014|OG000|Outcome|1 - SSRI|Participants will take escitalopram.
10879205|NCT00456014|OG000|Outcome|Tricyclic Group|7 participants who did not remit during the SSRI phase advanced to the tricyclic phase. 4 participants completed this phase.
10879206|NCT00456014|OG000|Outcome|1 - SSRI|Participants will complete an 8-week trial of the SSRI escitalopram, or, if not tolerated, an 8-week trial of the SSRI sertraline.
10879207|NCT00456014|EG000|Reported Event|1 - SSRI|Participants will take escitalopram.
10879208|NCT00456092|BG000|Baseline|Apremilast 40 mg QD|Participants received 40 mg apremilast once daily (QD) for 12 weeks in the Treatment Phase.
10879209|NCT00456092|BG001|Baseline|Apremilast 20 mg BID|Participants received 20 mg apremilast twice a day (BID) for 12 weeks in the Treatment Phase.
10879210|NCT00456092|BG002|Baseline|Placebo|Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
10879211|NCT00456092|BG003|Baseline|Total|Total of all reporting groups
10879212|NCT00456092|FG000|Participant Flow|Apremilast 40 mg QD|Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.
11348787|NCT04124536|EG003|Reported Event|HIV-Negative Control|"Single strategy for partner HIV testing~Partner notification services adapted for partners of HIV-negative women."
10879213|NCT00456092|FG001|Participant Flow|Apremilast 20 mg BID|Participants received 20 mg apremilast orally twice a day (BID) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 20 mg apremilast BID for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.
10879214|NCT00456092|FG002|Participant Flow|Placebo|Participants received matching placebo to apremilast orally BID for 12 weeks during the Treatment Phase. Participants who entered the Extension Phase were re-randomized on Day 85 to receive either 40 mg apremilast QD or 20 mg apremilast BID for 12 weeks.
10879215|NCT00456092|FG003|Participant Flow|Placebo/Apremilast 40 mg QD|Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase. The dose of apremilast was titrated starting at 10 mg QD during Days 85 to 87 followed by 20 mg QD during Days 88 to 91 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.
10879216|NCT00456092|FG004|Participant Flow|Placebo/Apremilast 20 mg BID|Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase. The dose of apremilast was titrated starting at 10 mg QD during Days 85 to 87 followed by 20 mg QD during Days 88 to 91 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.
10879217|NCT00456092|OG000|Outcome|Apremilast 40 mg QD|Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
10879218|NCT00456092|OG001|Outcome|Apremilast 20 mg BID|Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
10879219|NCT00456092|OG002|Outcome|Placebo|Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
10879220|NCT00456092|OG000|Outcome|Apremilast 40 mg QD|Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
10879221|NCT00456092|OG001|Outcome|Apremilast 20 mg BID|Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
10879222|NCT00456092|OG002|Outcome|Placebo/Apremilast 40 mg QD|Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
10879223|NCT00456092|OG003|Outcome|Placebo/Apremilast 20 mg BID|Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
10879224|NCT00456092|EG000|Reported Event|Week 12: Apremilast 40 mg QD|Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
10879225|NCT00456092|EG001|Reported Event|Week 12: Apremilast 20 mg BID|Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
10879226|NCT00456092|EG002|Reported Event|Week 12: Placebo|Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
10879227|NCT00456092|EG003|Reported Event|Week 24: Apremilast 40 mg QD|Participants who received 40 mg QD apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24.
10879228|NCT00456092|EG004|Reported Event|Week 24: Apremilast 20 mg BID|Participants who received 20 mg apremilast BID, regardless of when the apremilast exposure started (at Week 0, 12), up until Week 24.
10869855|NCT00410150|BG000|Baseline|Heliox Group|Patients randomized to the Heliox arm of the study
10869856|NCT00410150|BG001|Baseline|Control Group|Subjects randomized to the control arm of the study
10869857|NCT00410150|BG002|Baseline|Total|Total of all reporting groups
10869858|NCT00410150|FG000|Participant Flow|Heliox Group|Patients randomized to the Heliox arm of the study
10869859|NCT00410150|FG001|Participant Flow|Control Group|Subjects randomized to the control arm of the study
10869860|NCT00410150|OG000|Outcome|Heliox Group|Patients randomized to the Heliox arm of the study
10869861|NCT00410150|OG001|Outcome|Control Group|Subjects randomized to the control arm of the study
10869862|NCT00410150|EG000|Reported Event|Heliox Group|Patients randomized to the Heliox arm of the study
10869863|NCT00410150|EG001|Reported Event|Control Group|Subjects randomized to the control arm of the study
10869864|NCT00410163|BG000|Baseline|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
10869865|NCT00410163|BG001|Baseline|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
10869866|NCT00410163|BG002|Baseline|Total|Total of all reporting groups
10869867|NCT00410163|FG000|Participant Flow|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
10869868|NCT00410163|FG001|Participant Flow|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
10869869|NCT00410163|OG000|Outcome|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
10869870|NCT00410163|OG001|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
10869871|NCT00410163|OG000|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
10869872|NCT00410163|OG001|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
10869873|NCT00410163|EG000|Reported Event|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
10869874|NCT00410163|EG001|Reported Event|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
10869875|NCT00410163|EG002|Reported Event|Ofatumumab 500 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
10869876|NCT00410163|EG003|Reported Event|Ofatumumab 1000 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
10869877|NCT00410189|BG000|Baseline|ZD6474|ZD6474 300 mg by mouth daily.
10869878|NCT00410189|FG000|Participant Flow|ZD6474|ZD6474 300 mg by mouth daily.
10869879|NCT00410189|OG000|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
10869880|NCT00410189|EG000|Reported Event|ZD6474|ZD6474 300 mg by mouth daily.
10869881|NCT00410202|BG000|Baseline|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
10869882|NCT00410202|BG001|Baseline|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
10869883|NCT00410202|BG002|Baseline|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
10869884|NCT00410202|BG003|Baseline|Total|Total of all reporting groups
10869885|NCT00410202|FG000|Participant Flow|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
10869886|NCT00410202|FG001|Participant Flow|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
10869887|NCT00410202|FG002|Participant Flow|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
10869888|NCT00410202|OG000|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
10869889|NCT00410202|OG001|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
10869890|NCT00410202|OG002|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
10869891|NCT00410202|OG000|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
10869892|NCT00410202|EG000|Reported Event|ADV + LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
10869893|NCT00410202|EG001|Reported Event|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
10869894|NCT00410202|EG002|Reported Event|ETV + ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
10869895|NCT00410280|BG000|Baseline|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
10869896|NCT00410280|BG001|Baseline|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
10869897|NCT00410280|BG002|Baseline|Total|Total of all reporting groups
10869898|NCT00410280|FG000|Participant Flow|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
10869899|NCT00410280|FG001|Participant Flow|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
10869900|NCT00410280|OG000|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
10869901|NCT00410280|OG001|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
10869902|NCT00410280|EG000|Reported Event|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
10869903|NCT00410280|EG001|Reported Event|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
10869904|NCT00410384|BG000|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869905|NCT00410384|BG001|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869906|NCT00410384|BG002|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869907|NCT00410384|BG003|Baseline|Total|Total of all reporting groups
11098899|NCT01578577|EG001|Reported Event|EHMI|EHMI: The EHMI intervention consists of multiple components, all leveraged by the Epic EHR platform (Verona, WI). The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides
10869908|NCT00410384|FG000|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869909|NCT00410384|FG001|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869910|NCT00410384|FG002|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869911|NCT00410384|OG000|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869912|NCT00410384|OG001|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869913|NCT00410384|OG002|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869914|NCT00410384|EG000|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869915|NCT00410384|EG001|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869916|NCT00410384|EG002|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
10869917|NCT00410410|BG000|Baseline|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
10869918|NCT00410410|BG001|Baseline|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869919|NCT00410410|BG002|Baseline|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
10869920|NCT00410410|BG003|Baseline|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869921|NCT00410410|BG004|Baseline|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
10869922|NCT00410410|BG005|Baseline|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869923|NCT00410410|BG006|Baseline|Total|Total of all reporting groups
10869924|NCT00410410|FG000|Participant Flow|Induction Period Cohort 1 (IP1C)-Abatacept (ABA) 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869925|NCT00410410|FG001|Participant Flow|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869926|NCT00410410|FG002|Participant Flow|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
10869927|NCT00410410|FG003|Participant Flow|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869928|NCT00410410|FG004|Participant Flow|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869929|NCT00410410|FG005|Participant Flow|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869930|NCT00410410|FG006|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
10869931|NCT00410410|FG007|Participant Flow|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
10869932|NCT00410410|FG008|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
10869933|NCT00410410|OG000|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869934|NCT00410410|OG001|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869935|NCT00410410|OG002|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
10869936|NCT00410410|OG003|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869937|NCT00410410|OG000|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
10869938|NCT00410410|OG001|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869939|NCT00410410|OG002|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
10869940|NCT00410410|OG000|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869941|NCT00410410|OG001|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
10869942|NCT00410410|OG002|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869943|NCT00410410|OG003|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
10869944|NCT00410410|OG000|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
10869945|NCT00410410|OG001|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
10869946|NCT00410410|OG000|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
10869947|NCT00410410|OG004|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869948|NCT00410410|OG005|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869949|NCT00410410|OG000|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
10869950|NCT00410410|OG001|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869951|NCT00410410|OG000|Outcome|IP1C+IP2C: ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
10869952|NCT00410410|OG001|Outcome|IP1C+IP2C: ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869953|NCT00410410|OG002|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
10869954|NCT00410410|OG000|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
10869955|NCT00410410|OG001|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869956|NCT00410410|OG000|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869957|NCT00410410|EG000|Reported Event|ABA 30/~10 mg/kg,IP1C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
10869958|NCT00410410|EG001|Reported Event|ABA 30/~10mg/kg,IP2C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg.
10869959|NCT00410410|EG002|Reported Event|ABA 3 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
10869960|NCT00410410|EG003|Reported Event|ABA ~10 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869961|NCT00410410|EG004|Reported Event|ABA ~10mg/kg,IP2C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
10869962|NCT00410410|EG005|Reported Event|ABA ~10mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
10869963|NCT00410410|EG006|Reported Event|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
10869964|NCT00410410|EG007|Reported Event|Placebo, IP1C|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
10869965|NCT00410410|EG008|Reported Event|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
10869966|NCT00410423|BG000|Baseline|Bortezomib|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869967|NCT00410423|FG000|Participant Flow|Phase 1 - Bortezomib 0.7mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869968|NCT00410423|FG001|Participant Flow|Phase 1 - Bortezomib 1.0 mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869969|NCT00410423|FG002|Participant Flow|Phase 1 - Bortezomib 1.3 mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869970|NCT00410423|FG003|Participant Flow|Phase 2 - Bortezomib 1.3mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869971|NCT00410423|OG000|Outcome|Phase 1 - Bortezomib 0.7mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869972|NCT00410423|OG001|Outcome|Phase 1 - Bortezomib 1.0 mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869973|NCT00410423|OG002|Outcome|Phase 1 - Bortezomib 1.3mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869974|NCT00410423|OG000|Outcome|Phase 2 - Bortezomib 1.3mg/m^2|Bortezomib 1.3mg/m2: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
10869975|NCT00410423|EG000|Reported Event|Bortezomib|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
10869976|NCT00410488|BG000|Baseline|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
10869977|NCT00410488|BG001|Baseline|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
10869978|NCT00410488|BG002|Baseline|Total|Total of all reporting groups
10879229|NCT00456300|BG000|Baseline|All Study Participants|Following the baseline study with insulin, Participants were randomized to receive either Exenatide 1.25 mcg or Exenatide 2.5 mcg
10869979|NCT00410488|FG000|Participant Flow|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
10869980|NCT00410488|FG001|Participant Flow|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
10869981|NCT00410488|OG000|Outcome|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
10869982|NCT00410488|OG001|Outcome|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
10869983|NCT00410488|EG000|Reported Event|Palonosetron|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0) and Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
10869984|NCT00410514|BG000|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
10869985|NCT00410514|BG001|Baseline|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
10869986|NCT00410514|BG002|Baseline|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
10869987|NCT00410514|BG003|Baseline|Total|Total of all reporting groups
10869988|NCT00410514|FG000|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
10869989|NCT00410514|FG001|Participant Flow|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
10869990|NCT00410514|FG002|Participant Flow|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
10869991|NCT00410514|OG000|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
10869992|NCT00410514|OG001|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
10869993|NCT00410514|OG002|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
10869994|NCT00410514|EG000|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
10869995|NCT00410514|EG001|Reported Event|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
10869996|NCT00410514|EG002|Reported Event|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
10869997|NCT00410605|BG000|Baseline|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
10869998|NCT00410605|FG000|Participant Flow|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
10869999|NCT00410605|OG000|Outcome|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
10870000|NCT00410605|EG000|Reported Event|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
10870001|NCT00410761|BG000|Baseline|Vandetanib 300 mg|Vandetanib (300 mg daily)
10870002|NCT00410761|BG001|Baseline|Placebo|Placebo daily
10870003|NCT00410761|BG002|Baseline|Total|Total of all reporting groups
10870004|NCT00410761|FG000|Participant Flow|Vandetanib 300 mg|Vandetanib (300 mg daily)
10870005|NCT00410761|FG001|Participant Flow|Placebo|Placebo daily
10870006|NCT00410761|OG000|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
10870007|NCT00410761|OG001|Outcome|Placebo|Placebo daily
10870008|NCT00410761|EG000|Reported Event|Vandetanib 300 mg|Vandetanib (300 mg daily)
10870009|NCT00410761|EG001|Reported Event|Placebo|Placebo daily
10870010|NCT00410813|BG000|Baseline|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
10870011|NCT00410813|BG001|Baseline|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
10870012|NCT00410813|BG002|Baseline|Total|Total of all reporting groups
10870013|NCT00410813|FG000|Participant Flow|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
11098900|NCT01578577|EG002|Reported Event|Nurse Educator + EHMI|Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.
10870014|NCT00410813|FG001|Participant Flow|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
10870015|NCT00410813|OG000|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
10870016|NCT00410813|OG001|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
10870017|NCT00410813|OG000|Outcome|Dasatinib|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
10870018|NCT00410813|OG000|Outcome|NTx at Baseline|
10870019|NCT00410813|OG001|Outcome|NTx at 4 Weeks|
10870020|NCT00410813|OG002|Outcome|NTx at 8 Weeks|
10870021|NCT00410813|OG000|Outcome|BAP at Baseline|
10870022|NCT00410813|OG001|Outcome|BAP at 4 Weeks|
10870023|NCT00410813|OG002|Outcome|BAP at 8 Weeks|
10870024|NCT00410813|OG000|Outcome|Serum Biomarker at Baseline|
10870025|NCT00410813|OG001|Outcome|Serum Biomarker at 4 Weeks|
10870026|NCT00410813|OG002|Outcome|Serum Biomarker at 8 Weeks|
11098901|NCT01578707|BG000|Baseline|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
10870027|NCT00410813|OG000|Outcome|OC at Baseline|
10870028|NCT00410813|OG001|Outcome|OC at 4 Weeks|
10870029|NCT00410813|OG002|Outcome|OC at 8 Weeks|
10870030|NCT00410813|OG000|Outcome|OPG at Baseline|
10870031|NCT00410813|OG001|Outcome|OPG at 4 Weeks|
10870032|NCT00410813|OG002|Outcome|OPG at 8 Weeks|
10870033|NCT00410813|OG000|Outcome|TRAP at Baseline|
10870034|NCT00410813|OG001|Outcome|TRAP at 4 Weeks|
10870035|NCT00410813|OG002|Outcome|TRAP at 8 Weeks|
10870036|NCT00410813|OG000|Outcome|Dasatinib - Baseline|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
10870037|NCT00410813|OG001|Outcome|Dasatinib - Week 8|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
10870038|NCT00410813|OG002|Outcome|Dasatinib - Week 16|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
10870039|NCT00410813|OG003|Outcome|Dasatinib - Week 24|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
10870040|NCT00410813|EG000|Reported Event|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
10870041|NCT00410813|EG001|Reported Event|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
10870042|NCT00410826|BG000|Baseline|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
10870043|NCT00410826|BG001|Baseline|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
10870044|NCT00410826|BG002|Baseline|Total|Total of all reporting groups
10870045|NCT00410826|FG000|Participant Flow|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
10870046|NCT00410826|FG001|Participant Flow|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
10870047|NCT00410826|OG000|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
10870048|NCT00410826|OG001|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
10870049|NCT00410826|EG000|Reported Event|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
10870050|NCT00410826|EG001|Reported Event|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
10870051|NCT00410891|BG000|Baseline|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
10870052|NCT00410891|FG000|Participant Flow|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
10870053|NCT00410891|OG000|Outcome|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
10870054|NCT00410891|EG000|Reported Event|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
10870055|NCT00410904|BG000|Baseline|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
10870056|NCT00410904|BG001|Baseline|Arm I Cohort B - Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
10870057|NCT00410904|BG002|Baseline|Total|Total of all reporting groups
10870058|NCT00410904|FG000|Participant Flow|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
10870059|NCT00410904|FG001|Participant Flow|Arm I Cohort B- Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
10870060|NCT00410904|OG000|Outcome|Arm I - Cohort A, no Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
10870061|NCT00410904|OG001|Outcome|Arm I - Cohort B, Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
10870062|NCT00410904|OG000|Outcome|Arm I|"Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate~pemetrexed disodium"
10870063|NCT00410904|EG000|Reported Event|Arm I - Cohort A|"This is a one arm study with two cohorts.~Cohort A: No prior bevacizumab before entering into this trial~Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
10870064|NCT00410904|EG001|Reported Event|Arm I - Cohort B|"This is a one arm study with two cohorts.~Cohort B: Prior bevacizumab before entering into this trial~Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
10870065|NCT00411086|BG000|Baseline|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
10870066|NCT00411086|FG000|Participant Flow|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
10870067|NCT00411086|OG000|Outcome|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
10870068|NCT00411086|EG000|Reported Event|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
10870069|NCT00411151|BG000|Baseline|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
10870070|NCT00411151|FG000|Participant Flow|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
11098902|NCT01578707|BG001|Baseline|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
10870071|NCT00411151|OG000|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
10870072|NCT00411151|EG000|Reported Event|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
10870073|NCT00411216|BG000|Baseline|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
10870074|NCT00411216|BG001|Baseline|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
10870075|NCT00411216|BG002|Baseline|Total|Total of all reporting groups
10870076|NCT00411216|FG000|Participant Flow|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises~gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
11098903|NCT01578707|BG002|Baseline|Total|Total of all reporting groups
10870077|NCT00411216|FG001|Participant Flow|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements~Control exercises: saccadic eye movements against a plain background; no head movements"
10870078|NCT00411216|OG000|Outcome|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises~gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
10870079|NCT00411216|OG001|Outcome|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements~Control exercises: saccadic eye movements against a plain background; no head movements"
10870080|NCT00411216|EG000|Reported Event|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
10870081|NCT00411216|EG001|Reported Event|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
10870082|NCT00411398|BG000|Baseline|Memantine|Memantine tablets
10870083|NCT00411398|FG000|Participant Flow|Memantine|Memantine tablets
10870084|NCT00411398|OG000|Outcome|Memantine|Memantine tablets
10870085|NCT00411398|EG000|Reported Event|Memantine|Memantine tablets
10870086|NCT00411411|BG000|Baseline|Placebo|Placebo treatment
10870087|NCT00411411|BG001|Baseline|Januvia|Active treatment
10870088|NCT00411411|BG002|Baseline|Total|Total of all reporting groups
10870089|NCT00411411|FG000|Participant Flow|Placebo|Placebo treatment
10870090|NCT00411411|FG001|Participant Flow|Januvia|Active treatment
10870091|NCT00411411|OG000|Outcome|Placebo|Placebo: Placebo
10870092|NCT00411411|OG001|Outcome|Januvia|"Active treatment~Januvia: 200 mg t.i.d"
10870093|NCT00411411|OG000|Outcome|Placebo|"Placebo treatment, administered as tablets.~Placebo: Placebo"
11098904|NCT01578707|FG000|Participant Flow|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
10870094|NCT00411411|EG000|Reported Event|Placebo|No adverse events recorded
10870095|NCT00411411|EG001|Reported Event|Januvia|Active treatment. No adverse events recorded
10870096|NCT00411450|BG000|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
10870097|NCT00411450|FG000|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
10870098|NCT00411450|OG000|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
10870099|NCT00411450|OG001|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
10870100|NCT00411450|OG000|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
10870101|NCT00411450|EG000|Reported Event|Panitumumab + FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
10870102|NCT00411463|BG000|Baseline|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
10870103|NCT00411463|BG001|Baseline|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
10870104|NCT00411463|BG002|Baseline|Total|Total of all reporting groups
10870105|NCT00411463|FG000|Participant Flow|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
10879230|NCT00456300|FG000|Participant Flow|Insulin First, Then Exenatide1.25 mcg, Then Exenatide 2.5 mcg|Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 1.25 mcg + Insulin or Exenatide 2.5 mcg + Insulin
11098905|NCT01578707|FG001|Participant Flow|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
10870106|NCT00411463|FG001|Participant Flow|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
10870107|NCT00411463|OG000|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
10870108|NCT00411463|OG001|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
10870109|NCT00411463|OG000|Outcome|Psychotherapy|Patients assigned to talk therapy (IPSRT) intervention during 12 weeks of active enrollment in study.
10870110|NCT00411463|OG001|Outcome|Medication|Patients taking Quetiapine (Seroquel) during 12 weeks of active treatment.
10870111|NCT00411463|OG002|Outcome|Total|Total number of participants
10870112|NCT00411463|EG000|Reported Event|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
10870113|NCT00411463|EG001|Reported Event|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
10870114|NCT00411554|BG000|Baseline|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
10870115|NCT00411554|BG001|Baseline|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
10870116|NCT00411554|BG002|Baseline|Total|Total of all reporting groups
10870117|NCT00411554|FG000|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
10870118|NCT00411554|FG001|Participant Flow|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
10870119|NCT00411554|OG000|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
10870120|NCT00411554|OG001|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
10870121|NCT00411554|EG000|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
10870122|NCT00411554|EG001|Reported Event|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
10870123|NCT00411619|BG000|Baseline|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
10870124|NCT00411619|FG000|Participant Flow|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
10870125|NCT00411619|OG000|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus. The initial starting dose was to be 3.0 mg/m2/day taken either daily or every other day with titration to achieve target trough concentrations of 5 to 15 ng/mL, subject to tolerability. Study drug was self-administered orally (or administered by a caregiver) at the same time each day.
10870126|NCT00411619|OG000|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
10870127|NCT00411619|EG000|Reported Event|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
10870128|NCT00411632|BG000|Baseline|Bexarotene + Erlotinib|"Bexarotene 400 mg/m^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.~Bexarotene: 400 mg/m^2 by mouth daily x 28 Days~Erlotinib: 150 mg by mouth daily x 28 Days"
10870129|NCT00411632|FG000|Participant Flow|Erlotinib + Bexatrtene|"Bexarotene 400 mg/m^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.~Bexarotene: 400 mg/m^2 by mouth daily x 28 Days~Erlotinib: 150 mg by mouth daily x 28 Days"
10870130|NCT00411632|OG000|Outcome|Erlotinib + Bexatrtene|Erlotinib 150 mg by mouth daily + bexarotene 400 mg/m2/day daily (1 cycle =4 weeks) for 2 cycles, tumor response will be evaluated at the end of the second cycle. Patients who have progressed stop treatment and can renter the main BATTLE protocol and be assigned to another Phase II trial.
10870131|NCT00411632|EG000|Reported Event|Erlotinib + Bexatrtene|"Bexarotene 400 mg/m^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.~Bexarotene: 400 mg/m^2 by mouth daily x 28 Days~Erlotinib: 150 mg by mouth daily x 28 Days"
10870132|NCT00411645|BG000|Baseline|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
10870133|NCT00411645|BG001|Baseline|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
10870134|NCT00411645|BG002|Baseline|Total|Total of all reporting groups
10870135|NCT00411645|FG000|Participant Flow|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
10870136|NCT00411645|FG001|Participant Flow|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
10870137|NCT00411645|OG000|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
10870138|NCT00411645|OG001|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
11098906|NCT01578707|OG000|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
10870139|NCT00411645|OG000|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
10870140|NCT00411645|EG000|Reported Event|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
10870141|NCT00411645|EG001|Reported Event|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
10870142|NCT00411671|BG000|Baseline|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
11098907|NCT01578707|OG001|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
10870143|NCT00411671|FG000|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
10870144|NCT00411671|OG000|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
10870145|NCT00411671|EG000|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
10870146|NCT00411684|BG000|Baseline|Exp Arm|"A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse~CDB-2914"
10870147|NCT00411684|FG000|Participant Flow|CDB-2914|"A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse~CDB-2914"
10870148|NCT00411684|OG000|Outcome|CDB-2914|"A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse~CDB-2914"
10870149|NCT00411684|EG000|Reported Event|CDB-2914|"A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse~CDB-2914"
10870150|NCT00411749|BG000|Baseline|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
10870151|NCT00411749|BG001|Baseline|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
10870152|NCT00411749|BG002|Baseline|Total|Total of all reporting groups
10870153|NCT00411749|FG000|Participant Flow|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
10870154|NCT00411749|FG001|Participant Flow|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
10870155|NCT00411749|OG000|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
10870156|NCT00411749|OG001|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
10870157|NCT00411749|OG000|Outcome|V501-HPV 6|HPV 6 serum antibody titer measured in V501 vaccination group
10870158|NCT00411749|OG001|Outcome|V501-HPV 11|HPV 11 serum antibody titer measured in V501 vaccination group
10870159|NCT00411749|OG002|Outcome|V501-HPV 16|HPV 16 serum antibody titer measured in V501 vaccination group
10870160|NCT00411749|OG003|Outcome|V501-HPV 18|HPV 18 serum antibody titer measured in V501 vaccination group
10870161|NCT00411749|EG000|Reported Event|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
10870162|NCT00411749|EG001|Reported Event|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
10870163|NCT00411762|BG000|Baseline|PHY906 Administration|PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
10870164|NCT00411762|FG000|Participant Flow|PHY906 Administration|"PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle~Capecitabine~PHY906"
10846838|NCT00280241|EG000|Reported Event|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
10846839|NCT00280293|BG000|Baseline|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
10846840|NCT00280293|BG001|Baseline|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
10846841|NCT00280293|BG002|Baseline|Total|Total of all reporting groups
10846842|NCT00280293|FG000|Participant Flow|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
10846843|NCT00280293|FG001|Participant Flow|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
10846844|NCT00280293|OG000|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
10846845|NCT00280293|OG001|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
10846846|NCT00280293|EG000|Reported Event|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
10846847|NCT00280293|EG001|Reported Event|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
10846848|NCT00280384|BG000|Baseline|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846849|NCT00280384|BG001|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846850|NCT00280384|BG002|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846851|NCT00280384|BG003|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846852|NCT00280384|BG004|Baseline|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846853|NCT00280384|BG005|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846854|NCT00280384|BG006|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846855|NCT00280384|BG007|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846856|NCT00280384|BG008|Baseline|Total|Total of all reporting groups
10846857|NCT00280384|FG000|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846858|NCT00280384|FG001|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846859|NCT00280384|FG002|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846860|NCT00280384|FG003|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10870165|NCT00411762|OG000|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
10870166|NCT00411762|EG000|Reported Event|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
10870167|NCT00411788|BG000|Baseline|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
10870168|NCT00411788|FG000|Participant Flow|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
10870169|NCT00411788|OG000|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
10870170|NCT00411788|EG000|Reported Event|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
10870171|NCT00412061|BG000|Baseline|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
10870172|NCT00412061|BG001|Baseline|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
10870173|NCT00412061|BG002|Baseline|Total|Total of all reporting groups
10870174|NCT00412061|FG000|Participant Flow|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
10870175|NCT00412061|FG001|Participant Flow|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
10870176|NCT00412061|OG000|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
10870177|NCT00412061|OG001|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
10870178|NCT00412061|OG001|Outcome|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
10870179|NCT00412061|OG000|Outcome|Everolimus Open Label Arm|Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
10879231|NCT00456300|FG001|Participant Flow|Insulin First, Then Exenatide 2.5 mcg, Then Exenatide 1.25 mcg|Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 2.5 mcg + Insulin or Exenatide 1.25 mcg + Insulin
10870180|NCT00412061|EG000|Reported Event|Everolimus + Octreotide|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
10870181|NCT00412061|EG001|Reported Event|Placebo + Octreotide|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
10870182|NCT00412061|EG002|Reported Event|Everolimus Open Label|Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
10870183|NCT00412074|BG000|Baseline|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
10870184|NCT00412074|BG001|Baseline|2400 Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
10870185|NCT00412074|BG002|Baseline|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
10870186|NCT00412074|BG003|Baseline|Total|Total of all reporting groups
10870187|NCT00412074|FG000|Participant Flow|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
10870188|NCT00412074|FG001|Participant Flow|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
10870189|NCT00412074|FG002|Participant Flow|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
10870190|NCT00412074|OG000|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
10870191|NCT00412074|OG001|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
10870192|NCT00412074|OG002|Outcome|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
10870193|NCT00412074|OG000|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
10870194|NCT00412074|OG001|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
10870195|NCT00412074|OG002|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
10870196|NCT00412074|EG000|Reported Event|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
10870197|NCT00412074|EG001|Reported Event|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
10870198|NCT00412074|EG002|Reported Event|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
10879232|NCT00456300|OG000|Outcome|Exenatide 1.25 mcg + Insulin|Participants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection
10879233|NCT00456300|OG001|Outcome|Exenatide 2.5 mcg + Insulin|Participants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection
10846861|NCT00280384|FG004|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846862|NCT00280384|FG005|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846863|NCT00280384|FG006|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846864|NCT00280384|FG007|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846865|NCT00280384|OG000|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846866|NCT00280384|OG001|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846867|NCT00280384|OG002|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846868|NCT00280384|OG003|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846869|NCT00280384|OG004|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846870|NCT00280384|OG005|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846871|NCT00280384|OG006|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846872|NCT00280384|OG007|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846873|NCT00280384|EG000|Reported Event|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846874|NCT00280384|EG001|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846875|NCT00280384|EG002|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846876|NCT00280384|EG003|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
10846877|NCT00280384|EG004|Reported Event|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846878|NCT00280384|EG005|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846879|NCT00280384|EG006|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846880|NCT00280384|EG007|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
10846881|NCT00280397|BG000|Baseline|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
10846882|NCT00280397|FG000|Participant Flow|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
10846883|NCT00280397|OG000|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
10846884|NCT00280397|OG000|Outcome|E7080 - 16 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
10846885|NCT00280397|OG001|Outcome|E7080 - 20 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
10846886|NCT00280397|EG000|Reported Event|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
10846887|NCT00280566|BG000|Baseline|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
10846888|NCT00280566|BG001|Baseline|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
10846889|NCT00280566|BG002|Baseline|Total|Total of all reporting groups
10870199|NCT00412087|BG000|Baseline|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
10870200|NCT00412087|BG001|Baseline|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
10870201|NCT00412087|BG002|Baseline|Total|Total of all reporting groups
10870202|NCT00412087|FG000|Participant Flow|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
10870203|NCT00412087|FG001|Participant Flow|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
10870204|NCT00412087|OG000|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
10870205|NCT00412087|OG001|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
10870206|NCT00412087|EG000|Reported Event|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
10870207|NCT00412087|EG001|Reported Event|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
10870208|NCT00412113|BG000|Baseline|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
10870209|NCT00412113|BG001|Baseline|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
10870210|NCT00412113|BG002|Baseline|Total|Total of all reporting groups
10870211|NCT00412113|FG000|Participant Flow|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
10870212|NCT00412113|FG001|Participant Flow|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
10870213|NCT00412113|OG000|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
10870214|NCT00412113|OG001|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
10870215|NCT00412113|EG000|Reported Event|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
10870216|NCT00412113|EG001|Reported Event|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
10870217|NCT00412217|BG000|Baseline|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
10870218|NCT00412217|BG001|Baseline|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
10870219|NCT00412217|BG002|Baseline|Total|Total of all reporting groups
10870220|NCT00412217|FG000|Participant Flow|Erlotinib|Participants with histologically confirmed advanced squamous cell carcinoma (SCC) of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 milligrams (mg) once daily for 1 year until disease progression or intolerable toxicity.
10870221|NCT00412217|FG001|Participant Flow|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
10870222|NCT00412217|OG000|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
10870223|NCT00412217|OG001|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
10870224|NCT00412217|EG000|Reported Event|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
10870225|NCT00412217|EG001|Reported Event|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
10870226|NCT00412243|BG000|Baseline|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
10870227|NCT00412243|FG000|Participant Flow|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
10870228|NCT00412243|OG000|Outcome|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
10870229|NCT00412243|EG000|Reported Event|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
10870230|NCT00412360|BG000|Baseline|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
10870231|NCT00412360|BG001|Baseline|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
10870232|NCT00412360|BG002|Baseline|Total|Total of all reporting groups
10870233|NCT00412360|FG000|Participant Flow|Single UCB Transplant|Single Cord Blood Unit Transplantation: Unrelated donor, single cord blood unit
10870234|NCT00412360|FG001|Participant Flow|Double UCB Transplant|Double Cord Blood Unit Transplantation: Unrelated donor, double cord blood unit
10870235|NCT00412360|OG000|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
10870236|NCT00412360|OG001|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
10870237|NCT00412360|EG000|Reported Event|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
10870238|NCT00412360|EG001|Reported Event|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
10870239|NCT00412373|BG000|Baseline|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
10870240|NCT00412373|BG001|Baseline|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
10870241|NCT00412373|BG002|Baseline|Total|Total of all reporting groups
10870242|NCT00412373|FG000|Participant Flow|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
10870243|NCT00412373|FG001|Participant Flow|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
10870244|NCT00412373|OG000|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
10870245|NCT00412373|OG001|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
10870246|NCT00412373|EG000|Reported Event|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
10879234|NCT00456300|OG002|Outcome|Insulin Monotherapy|Participants who received Insulin alone as a single subcutaneous injection, part of baseline study
10879235|NCT00456300|EG000|Reported Event|Exenatide 1.25 mcg + Insulin|Participants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection
10879236|NCT00456300|EG001|Reported Event|Exenatide 2.5 mcg + Insulin|Participants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection
10870247|NCT00412373|EG001|Reported Event|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
10870248|NCT00412425|BG000|Baseline|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
10870249|NCT00412425|BG001|Baseline|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
10870250|NCT00412425|BG002|Baseline|Total|Total of all reporting groups
10870251|NCT00412425|FG000|Participant Flow|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
10870252|NCT00412425|FG001|Participant Flow|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
10870253|NCT00412425|OG000|Outcome|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
10870254|NCT00412425|OG001|Outcome|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
10870255|NCT00412425|EG000|Reported Event|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
10870256|NCT00412425|EG001|Reported Event|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
10870257|NCT00412451|BG000|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
10870258|NCT00412451|BG001|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
10870259|NCT00412451|BG002|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
10870260|NCT00412451|BG003|Baseline|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
10870261|NCT00412451|BG004|Baseline|Total|Total of all reporting groups
10870262|NCT00412451|FG000|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injections versus sham injection
10870263|NCT00412451|FG001|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
10870264|NCT00412451|FG002|Participant Flow|0criplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
10870265|NCT00412451|FG003|Participant Flow|Sham Injection|Sham intravitreal injection
10870266|NCT00412451|OG000|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
10870267|NCT00412451|OG001|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
10870268|NCT00412451|OG002|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
10870269|NCT00412451|OG003|Outcome|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
10870270|NCT00412451|EG000|Reported Event|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
10870271|NCT00412451|EG001|Reported Event|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
10870272|NCT00412451|EG002|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
10870273|NCT00412451|EG003|Reported Event|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
10870274|NCT00412464|BG000|Baseline|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
10870275|NCT00412464|FG000|Participant Flow|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
10870276|NCT00412464|OG000|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
10870277|NCT00412464|EG000|Reported Event|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
10870278|NCT00412516|BG000|Baseline|Group 1|SA 14-14-2 followed by measles vaccine one month later
10870279|NCT00412516|BG001|Baseline|Group 2|Measles and SA 14-14-2 given concurrently
10870280|NCT00412516|BG002|Baseline|Group 3|Measles vaccine followed by SA 14-14-2 one month later
10870281|NCT00412516|BG003|Baseline|Total|Total of all reporting groups
10870282|NCT00412516|FG000|Participant Flow|Group 1|SA 14-14-2 followed by measles vaccine one month later
10870283|NCT00412516|FG001|Participant Flow|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
10870284|NCT00412516|FG002|Participant Flow|Group 3|Measles vaccine followed by SA 14-14-2 one month later
10870285|NCT00412516|OG000|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
10870286|NCT00412516|OG001|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
10870287|NCT00412516|OG002|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
10870288|NCT00412516|EG000|Reported Event|Group 1|SA 14-14-2 followed by measles vaccine one month later
10870289|NCT00412516|EG001|Reported Event|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
10870290|NCT00412516|EG002|Reported Event|Group 3|Measles vaccine followed by SA 14-14-2 one month later
10870291|NCT00412529|BG000|Baseline|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
10870292|NCT00412529|BG001|Baseline|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
10870293|NCT00412529|BG002|Baseline|Total|Total of all reporting groups
10870294|NCT00412529|FG000|Participant Flow|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
10870295|NCT00412529|FG001|Participant Flow|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
10870296|NCT00412529|OG000|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
10870297|NCT00412529|OG001|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
10870298|NCT00412529|EG000|Reported Event|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
10870299|NCT00412529|EG001|Reported Event|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
10870300|NCT00412542|BG000|Baseline|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
10846890|NCT00280566|FG000|Participant Flow|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
10846891|NCT00280566|FG001|Participant Flow|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
10846892|NCT00280566|FG002|Participant Flow|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
10846893|NCT00280566|OG000|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
10846894|NCT00280566|OG001|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
10846895|NCT00280566|EG000|Reported Event|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
10846896|NCT00280566|EG001|Reported Event|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
10846897|NCT00280566|EG002|Reported Event|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
10846898|NCT00280683|BG000|Baseline|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
10846899|NCT00280683|BG001|Baseline|Placebo|Placebo intervention
10846900|NCT00280683|BG002|Baseline|Total|Total of all reporting groups
10846901|NCT00280683|FG000|Participant Flow|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
10846902|NCT00280683|FG001|Participant Flow|Placebo|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
10846903|NCT00280683|OG000|Outcome|Arginine|The L-arginine 1g tablets were from Jarrow formulas (Los Angeles, CA). The name of these tablets is Arginine 1000.
10846904|NCT00280683|OG001|Outcome|Placebo|Matching placebo tablets were made by Jarrow Formulas.
10846905|NCT00280683|OG000|Outcome|Arginine|L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
10846906|NCT00280683|OG001|Outcome|Placebo|Matching placebo tablets were disbursed by the Investigational Drug Service.
10846907|NCT00280683|EG000|Reported Event|Arginine|L-arginine 1 g tablets were made by Jarrow Formulas.
10846908|NCT00280683|EG001|Reported Event|Placebo|Matching placebo tablets were purchased from Jarrow Formulas.
10846909|NCT00280735|BG000|Baseline|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
10846910|NCT00280735|FG000|Participant Flow|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
10846911|NCT00280735|OG000|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
10846912|NCT00280735|OG000|Outcome|Single Arm Trial|Patients who relapsed
10846913|NCT00280735|OG000|Outcome|Grade 3 %|Percentage of patients receiving treatment who developed this toxicity
10846914|NCT00280735|OG001|Outcome|Grade 4 %|Percentage of patients receiving treatment who developed this toxicity
10846915|NCT00280735|OG002|Outcome|Grade 3/4 %|Percentage of patients receiving treatment who developed this toxicity
10846916|NCT00280735|EG000|Reported Event|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
10846917|NCT00280748|BG000|Baseline|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
10846918|NCT00280748|FG000|Participant Flow|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
10846919|NCT00280748|OG000|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
10846920|NCT00280748|EG000|Reported Event|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
10846921|NCT00280826|BG000|Baseline|Efalizumab|Treatment of cystoid macular edema due to uveitis
10846922|NCT00280826|FG000|Participant Flow|Efalizumab|Treatment of cystoid macular edema due to uveitis
10846923|NCT00280826|OG000|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
10846924|NCT00280826|EG000|Reported Event|Efalizumab|Treatment of cystoid macular edema due to uveitis
10846925|NCT00280904|BG000|Baseline|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
10846926|NCT00280904|FG000|Participant Flow|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
10846927|NCT00280904|OG000|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated(AI)or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
10846928|NCT00280904|OG000|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated (AI) or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
10846929|NCT00280904|EG000|Reported Event|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
10846930|NCT00280917|BG000|Baseline|CF101 0.1mg|CF101 0.1 mg q12 hours for 12 weeks
10846931|NCT00280917|BG001|Baseline|CF101 1mg|CF101 1 mg q12 hours for 12 weeks
10846932|NCT00280917|BG002|Baseline|CF101 4mg|CF101 4 mg q12 hours for 12 weeks
10846933|NCT00280917|BG003|Baseline|Placebo|Matching Placebo q12 hours for 12 weeks
10846934|NCT00280917|BG004|Baseline|Total|Total of all reporting groups
10846935|NCT00280917|FG000|Participant Flow|CF101 0.1mg|CF101 0.1 mg q12 hours orally
10846936|NCT00280917|FG001|Participant Flow|CF101 1mg|CF101 1mg q12 hours orally
10846937|NCT00280917|FG002|Participant Flow|CF101 4mg|CF101 4mg q12 hours orally
10846938|NCT00280917|FG003|Participant Flow|Placebo|Matching placebo q12 hours orally
10846939|NCT00280917|OG000|Outcome|CF101 0.1 mg|CF101 0.1 mg q12 hours for 12 weeks
10846940|NCT00280917|OG001|Outcome|CF101 1 mg|CF101 1 mg q12 hours for 12 weeks
10846941|NCT00280917|OG002|Outcome|CF101 4 mg|CF101 4 mg q12 hours for 12 weeks
10846942|NCT00280917|OG003|Outcome|Placebo|Matching placebo q12 hours for 12 weeks
10846943|NCT00280917|EG000|Reported Event|CF101 0.1mg|CF101 0.1 mg given orally q12h for 12 weeks
10846944|NCT00280917|EG001|Reported Event|CF101 1mg|CF101 1 mg given orally q12h for 12 weeks
10846945|NCT00280917|EG002|Reported Event|CF101 4mg|CF101 4 mg given orally q12h for 12 weeks
10846946|NCT00280917|EG003|Reported Event|Placebo|Matching placebo
10846947|NCT00281021|BG000|Baseline|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
10846948|NCT00281021|FG000|Participant Flow|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
10846949|NCT00281021|OG000|Outcome|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
10846950|NCT00281021|EG000|Reported Event|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
10846951|NCT00281099|BG000|Baseline|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
10846952|NCT00281099|BG001|Baseline|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
10846953|NCT00281099|BG002|Baseline|Total|Total of all reporting groups
10846954|NCT00281099|FG000|Participant Flow|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
10846955|NCT00281099|FG001|Participant Flow|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
10846956|NCT00281099|OG000|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
10846957|NCT00281099|OG001|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
10846958|NCT00281099|OG000|Outcome|All Screened Patients|All Patients Screened for Possible Enrollment
10846959|NCT00281099|EG000|Reported Event|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
10846960|NCT00281099|EG001|Reported Event|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
10846961|NCT00281463|BG000|Baseline|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
10846962|NCT00281463|FG000|Participant Flow|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
10846963|NCT00281463|OG000|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
10870301|NCT00412542|BG001|Baseline|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
10870302|NCT00412542|BG002|Baseline|Total|Total of all reporting groups
10870303|NCT00412542|FG000|Participant Flow|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
10870304|NCT00412542|FG001|Participant Flow|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
10870305|NCT00412542|OG000|Outcome|Participants With Recurrent Malignant Gliomas|The endpoints combined results of all strata (Arm 1 of Glioblastoma Multiforme: Thalidomide + CPT-11 and Arm 2 of Anaplastic Gliomas: Thalidomide + CPT-11).
10870306|NCT00412542|EG000|Reported Event|Patients With Recurrent Malignant Gliomas|The endpoints combined results of all strata
10870307|NCT00412607|BG000|Baseline|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
10870308|NCT00412607|FG000|Participant Flow|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
10870309|NCT00412607|OG000|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
10870310|NCT00412607|OG000|Outcome|Total|Total number of subjects who completed 12-month, 2-year, and 3-year follow-up respectively.
10870311|NCT00412607|OG001|Outcome|Reported Recurrence|Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
10870312|NCT00412607|OG002|Outcome|Reported No Recurrence|Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
10870313|NCT00412607|EG000|Reported Event|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
10870314|NCT00412737|BG000|Baseline|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
10870315|NCT00412737|BG001|Baseline|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
10870316|NCT00412737|BG002|Baseline|Total|Total of all reporting groups
10870317|NCT00412737|FG000|Participant Flow|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
10870318|NCT00412737|FG001|Participant Flow|Oseltamivir|Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
10870319|NCT00412737|OG000|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
10870320|NCT00412737|OG001|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
10870321|NCT00412737|EG000|Reported Event|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
10870322|NCT00412737|EG001|Reported Event|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
10870323|NCT00412750|BG000|Baseline|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
10870324|NCT00412750|BG001|Baseline|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
10870325|NCT00412750|BG002|Baseline|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
10870326|NCT00412750|BG003|Baseline|Total|Total of all reporting groups
10870327|NCT00412750|FG000|Participant Flow|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
10870328|NCT00412750|FG001|Participant Flow|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
10870329|NCT00412750|FG002|Participant Flow|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
10870330|NCT00412750|OG000|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
10870331|NCT00412750|OG001|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
10870332|NCT00412750|OG001|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
10870333|NCT00412750|OG002|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
10870334|NCT00412750|OG000|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
10870335|NCT00412750|EG000|Reported Event|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
10870336|NCT00412750|EG001|Reported Event|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
10870337|NCT00412750|EG002|Reported Event|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
10870338|NCT00412841|BG000|Baseline|Atorvastatin|Atorvastatin 40mg
10870339|NCT00412841|BG001|Baseline|Placebo|
10870340|NCT00412841|BG002|Baseline|Total|Total of all reporting groups
10870341|NCT00412841|FG000|Participant Flow|Atorvastatin|40 mg
10870342|NCT00412841|FG001|Participant Flow|Placebo|
10870343|NCT00412841|OG000|Outcome|Atorvastatin|Atorvastatin 40mg
10870344|NCT00412841|OG001|Outcome|Placebo|
10870345|NCT00412841|OG000|Outcome|Atorvastatin|40 mg
10870346|NCT00412841|EG000|Reported Event|Atorvastatin|Atorvastatin 40mg
10870347|NCT00412841|EG001|Reported Event|Placebo|Placebo
10870348|NCT00412854|BG000|Baseline|Infanrix/Hib Group|Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
10870349|NCT00412854|BG001|Baseline|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
10870350|NCT00412854|BG002|Baseline|Total|Total of all reporting groups
10870351|NCT00412854|FG000|Participant Flow|Infanrix/Hib Group|Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
10870352|NCT00412854|FG001|Participant Flow|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
10870353|NCT00412854|OG000|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
10870354|NCT00412854|OG001|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
10870355|NCT00412854|EG000|Reported Event|Infanrix/Hib Group|Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
10870356|NCT00412854|EG001|Reported Event|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
11098908|NCT01578707|EG000|Reported Event|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
11098909|NCT01578707|EG001|Reported Event|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
11098910|NCT01578772|BG000|Baseline|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
11098911|NCT01578772|FG000|Participant Flow|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
11098912|NCT01578772|OG000|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
11098913|NCT01578772|OG001|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
10870357|NCT00412867|BG000|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10870358|NCT00412867|FG000|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10870359|NCT00412867|OG000|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10870360|NCT00412867|EG000|Reported Event|Alteplase (Non-Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10870361|NCT00412867|EG001|Reported Event|Alteplase (Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10870362|NCT00412893|BG000|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
10870363|NCT00412893|BG001|Baseline|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
10870364|NCT00412893|BG002|Baseline|Total|Total of all reporting groups
10870365|NCT00412893|FG000|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
10870366|NCT00412893|FG001|Participant Flow|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
10870367|NCT00412893|OG000|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
10870368|NCT00412893|OG001|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
10870369|NCT00412893|EG000|Reported Event|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
10879237|NCT00456300|EG002|Reported Event|Insulin Monotherapy|Participants who received Insulin alone as a single subcutaneous injection, as part of the baseline study visit
10870370|NCT00412893|EG001|Reported Event|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
10870371|NCT00412958|BG000|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection
10870372|NCT00412958|BG001|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
10870373|NCT00412958|BG002|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
10870374|NCT00412958|BG003|Baseline|Placebo|Intravitreal injection of placebo.
10870375|NCT00412958|BG004|Baseline|Total|Total of all reporting groups
10870376|NCT00412958|FG000|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
10870377|NCT00412958|FG001|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
10870378|NCT00412958|FG002|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
10870379|NCT00412958|FG003|Participant Flow|Placebo|Intravitreal injection of placebo.
10870380|NCT00412958|OG000|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
10870381|NCT00412958|OG001|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
10870382|NCT00412958|OG002|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
10870383|NCT00412958|OG003|Outcome|Placebo|Intravitreal injection of placebo.
10870384|NCT00412958|EG000|Reported Event|Ocriplasmin 25µg|25µg of ocriplasmin intravitreal injection.
10870385|NCT00412958|EG001|Reported Event|Ocriplasmin 75µg|75µg of ocriplasmin intravitreal injection.
10870386|NCT00412958|EG002|Reported Event|Ocriplasmin 125µg|125µg of ocriplasmin intravitreal injection.
10870387|NCT00412958|EG003|Reported Event|Placebo|Intravitreal injection of placebo.
10870388|NCT00412971|BG000|Baseline|Hexvix Cystoscopy Group|
10870389|NCT00412971|BG001|Baseline|White Light|Standard White light cystoscopy
10870390|NCT00412971|BG002|Baseline|Total|Total of all reporting groups
10870391|NCT00412971|FG000|Participant Flow|Hexvix Cystoscopy Group|
10870392|NCT00412971|FG001|Participant Flow|White Light|Standard White light cystoscopy
10870393|NCT00412971|OG000|Outcome|Hexvix Cystoscopy Group|
10870394|NCT00412971|OG001|Outcome|White Light|Standard White light cystoscopy
10870395|NCT00412971|EG000|Reported Event|Hexvix Cystoscopy Group|
10870396|NCT00412971|EG001|Reported Event|White Light|Standard White light cystoscopy
10870397|NCT00412984|BG000|Baseline|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
10870398|NCT00412984|BG001|Baseline|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
10870399|NCT00412984|BG002|Baseline|Total|Total of all reporting groups
10870400|NCT00412984|FG000|Participant Flow|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
10870401|NCT00412984|FG001|Participant Flow|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
10870402|NCT00412984|OG000|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
10870403|NCT00412984|OG001|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
10870404|NCT00412984|EG000|Reported Event|Warfarin|
10870405|NCT00412984|EG001|Reported Event|Apixaban|
10870406|NCT00413010|BG000|Baseline|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
10870407|NCT00413010|BG001|Baseline|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
10870408|NCT00413010|BG002|Baseline|Total|Total of all reporting groups
10879238|NCT00456365|BG000|Baseline|Pravastatin|"Pravastatin~pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)"
10870409|NCT00413010|FG000|Participant Flow|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
10870410|NCT00413010|FG001|Participant Flow|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
10870411|NCT00413010|OG000|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
10870412|NCT00413010|OG001|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
10870413|NCT00413010|EG000|Reported Event|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
10870414|NCT00413010|EG001|Reported Event|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
10870415|NCT00413036|BG000|Baseline|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
10870416|NCT00413036|FG000|Participant Flow|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
10870417|NCT00413036|OG000|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
10870418|NCT00413036|EG000|Reported Event|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
10870419|NCT00413049|BG000|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
10870420|NCT00413049|BG001|Baseline|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
11098914|NCT01578772|EG000|Reported Event|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
10870421|NCT00413049|BG002|Baseline|Total|Total of all reporting groups
10870422|NCT00413049|FG000|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
10870423|NCT00413049|FG001|Participant Flow|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
10870424|NCT00413049|OG000|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
10870425|NCT00413049|OG001|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
10870426|NCT00413049|EG000|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
10870427|NCT00413049|EG001|Reported Event|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
10870428|NCT00413153|BG000|Baseline|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
11098915|NCT01578850|BG000|Baseline|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
10870429|NCT00413153|BG001|Baseline|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
10870430|NCT00413153|BG002|Baseline|Total|Total of all reporting groups
10870431|NCT00413153|FG000|Participant Flow|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
10870432|NCT00413153|FG001|Participant Flow|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
10879239|NCT00456365|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo daily"
11098916|NCT01578850|BG001|Baseline|Placebo|Participants were randomized to receive PBO 50 mg QW with MTX (with or without other DMARDs).
11098917|NCT01578850|BG002|Baseline|Total|Total of all reporting groups
11098918|NCT01578850|FG000|Participant Flow|Open-Label Treatment|Participants in open-label treatment received Etanercept (ETN) 50 milligram (mg) once a week (QW) with MTX (with or without other DMARDs).
11098919|NCT01578850|FG001|Participant Flow|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
10870433|NCT00413153|OG000|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
10870434|NCT00413153|OG001|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
10870435|NCT00413153|EG000|Reported Event|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
10870436|NCT00413153|EG001|Reported Event|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
10870437|NCT00413166|BG000|Baseline|ATRA + ATO: Low Risk (WBC<10,000)|"All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1~Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.~Post CR~1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a 2-weeks on -2-weeks off basis until therapy with ATO completed."
10870438|NCT00413166|BG001|Baseline|ATRA+ATO+IDA: High Risk (WBC >10,000)|"Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.~ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.~Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date."
10870439|NCT00413166|BG002|Baseline|ATO+ATRA+GO|"Induction ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.~Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete."
10870440|NCT00413166|BG003|Baseline|Total|Total of all reporting groups
10870441|NCT00413166|FG000|Participant Flow|ATRA + ATO: Low Risk (WBC<10,000)|"All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1~Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.~Post CR~1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a 2-weeks on -2-weeks off basis until therapy with ATO completed."
10870442|NCT00413166|FG001|Participant Flow|ATRA+ATO+IDA: High Risk (WBC >10,000)|"Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.~ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.~Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date."
10870443|NCT00413166|FG002|Participant Flow|ATO+ATRA+GO|"ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.~Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete."
10870444|NCT00413166|OG000|Outcome|ATRA + ATO: Low Risk (WBC<10,000)|"All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1~Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.~Post CR~1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a 2-weeks on -2-weeks off basis until therapy with ATO completed."
10870445|NCT00413166|OG001|Outcome|ATRA+ATO+IDA: High Risk (WBC >10,000)|"Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.~ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.~Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date."
11098920|NCT01578850|FG002|Participant Flow|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
11098921|NCT01578850|OG000|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
10879240|NCT00456365|BG002|Baseline|Total|Total of all reporting groups
10879241|NCT00456365|FG000|Participant Flow|Pravastatin|"Pravastatin~pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)"
11098922|NCT01578850|OG001|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
11098923|NCT01578850|OG000|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
11098924|NCT01578850|EG000|Reported Event|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg with MTX (with or without other DMARDs).
10870446|NCT00413166|OG002|Outcome|ATO+ATRA+GO|"Induction ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.~Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete."
10870447|NCT00413166|EG000|Reported Event|ATRA + ATO: Low Risk (WBC<10,000)|"All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1~Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.~Post CR~1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a 2-weeks on -2-weeks off basis until therapy with ATO completed."
10870448|NCT00413166|EG001|Reported Event|ATRA+ATO+IDA: High Risk (WBC >10,000)|"Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.~ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.~Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date."
10870449|NCT00413166|EG002|Reported Event|ATO+ATRA+GO|"Induction ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.~Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete."
10870450|NCT00413192|BG000|Baseline|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870451|NCT00413192|BG001|Baseline|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870452|NCT00413192|BG002|Baseline|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870453|NCT00413192|BG003|Baseline|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870454|NCT00413192|BG004|Baseline|Total|Total of all reporting groups
10870455|NCT00413192|FG000|Participant Flow|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870456|NCT00413192|FG001|Participant Flow|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870457|NCT00413192|FG002|Participant Flow|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870458|NCT00413192|FG003|Participant Flow|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
11098925|NCT01578850|EG001|Reported Event|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
10879242|NCT00456365|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo daily"
11098926|NCT01578850|EG002|Reported Event|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
10870459|NCT00413192|OG000|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870460|NCT00413192|OG001|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870461|NCT00413192|OG002|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870462|NCT00413192|OG003|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870463|NCT00413192|EG000|Reported Event|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870464|NCT00413192|EG001|Reported Event|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870465|NCT00413192|EG002|Reported Event|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870466|NCT00413192|EG003|Reported Event|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
10870467|NCT00413218|BG000|Baseline|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
10870468|NCT00413218|BG001|Baseline|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
10870469|NCT00413218|BG002|Baseline|Total|Total of all reporting groups
10870470|NCT00413218|FG000|Participant Flow|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
10870471|NCT00413218|FG001|Participant Flow|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
10870472|NCT00413218|OG000|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
10870473|NCT00413218|OG001|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
10870474|NCT00413218|OG000|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic participants could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.
10879243|NCT00456365|OG000|Outcome|Pravastatin|"Pravastatin~pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)"
10879244|NCT00456365|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo daily"
10870475|NCT00413218|EG000|Reported Event|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.
10870476|NCT00413218|EG001|Reported Event|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
10870477|NCT00413231|BG000|Baseline|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
10870478|NCT00413231|FG000|Participant Flow|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
10870479|NCT00413231|OG000|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
10870480|NCT00413231|OG000|Outcome|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.~There were no other arms for this study.~Valiant Thoracic Stent Graft System: Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm)."
10870481|NCT00413231|EG000|Reported Event|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.~There were no other arms for this study."
10870482|NCT00413244|BG000|Baseline|Androgel|Androgel 5 grams
10870483|NCT00413244|BG001|Baseline|Placebo|Matching Placebo
10870484|NCT00413244|BG002|Baseline|Total|Total of all reporting groups
10870485|NCT00413244|FG000|Participant Flow|Androgel|Androgel 5 grams
10870486|NCT00413244|FG001|Participant Flow|Placebo|Matching Placebo
10870487|NCT00413244|OG000|Outcome|Androgel|Androgel 5 grams
10870488|NCT00413244|OG001|Outcome|Placebo|Matching Placebo
10870489|NCT00413244|EG000|Reported Event|Androgel|Androgel 5 grams
10870490|NCT00413244|EG001|Reported Event|Placebo|Matching Placebo
10870491|NCT00413283|BG000|Baseline|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870492|NCT00413283|BG001|Baseline|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870493|NCT00413283|BG002|Baseline|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870494|NCT00413283|BG003|Baseline|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870495|NCT00413283|BG004|Baseline|Total|Total of all reporting groups
10870496|NCT00413283|FG000|Participant Flow|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870497|NCT00413283|FG001|Participant Flow|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870498|NCT00413283|FG002|Participant Flow|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870499|NCT00413283|FG003|Participant Flow|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10879245|NCT00456365|OG000|Outcome|Pravastatin|Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
10879246|NCT00456365|OG001|Outcome|Placebo|Placebo daily
10879247|NCT00456365|EG000|Reported Event|Pravastatin|Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
10870500|NCT00413283|OG000|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870501|NCT00413283|OG001|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870502|NCT00413283|OG002|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870503|NCT00413283|OG003|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870504|NCT00413283|EG000|Reported Event|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870505|NCT00413283|EG001|Reported Event|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870506|NCT00413283|EG002|Reported Event|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870507|NCT00413283|EG003|Reported Event|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
10870508|NCT00413335|BG000|Baseline|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
10870509|NCT00413335|BG001|Baseline|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
10870510|NCT00413335|BG002|Baseline|Total|Total of all reporting groups
10870511|NCT00413335|FG000|Participant Flow|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
10870512|NCT00413335|FG001|Participant Flow|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
10870513|NCT00413335|OG000|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
10870514|NCT00413335|OG001|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
10870515|NCT00413335|EG000|Reported Event|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
10879248|NCT00456365|EG001|Reported Event|Placebo|Placebo daily
10879249|NCT00456495|BG000|Baseline|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
10879250|NCT00456495|FG000|Participant Flow|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
10870516|NCT00413335|EG001|Reported Event|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
10870517|NCT00413374|BG000|Baseline|Enoxaparin 1.5 mg/kg Daily|
10870518|NCT00413374|BG001|Baseline|Enoxaparin 1 mg/kg Twice Daily|
10870519|NCT00413374|BG002|Baseline|Total|Total of all reporting groups
10870520|NCT00413374|FG000|Participant Flow|Enoxaparin 1.5 mg/kg Daily|the cases were started on 1.5 mg/kg once daily enoxaparin as a bridge to warfarin.
10870521|NCT00413374|FG001|Participant Flow|Enoxaparin 1 mg/kg Twice Daily|"The controls had been treated with enoxaparin 1 mg/kg twice daily as a ''bridge'' to warfarin.~These are historical controls.~Two previously treated controls were matched for each case. Controls were matched by age (+10 years), gender, and location of VTE. The controls had been treated with enoxaparin 1 mg/kg twice daily as a ''bridge'' to warfarin."
10870522|NCT00413374|OG000|Outcome|Enoxaparin 1.5 mg/kg Daily|Study participants receiving Enoxaparin once daily who developed a major bleeding complication within 30 days.
10870523|NCT00413374|OG001|Outcome|Enoxaparin 1 mg/kg Twice Daily|
10870524|NCT00413374|OG000|Outcome|Enoxaparin 1.5 mg/kg Daily|Participants receiving Enoxaparin once daily who developed a VTE (either a DVT or PE) within 30 days.
10870525|NCT00413374|OG000|Outcome|Enoxaparin 1.5 mg/kg Once Daily|the cases were started on 1.5 mg/kg once daily enoxaparin as a bridge to warfarin
10870526|NCT00413374|OG001|Outcome|Enoxaparin 1 mg/kg Twice Daily|The controls had been treated with enoxaparin 1 mg/kg twice daily as a ''bridge'' to warfarin.
10870527|NCT00413374|EG000|Reported Event|Enoxaparin 1.5 mg/kg Daily|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
10870528|NCT00413374|EG001|Reported Event|Enoxaparin 1 mg/kg Twice Daily|
10870529|NCT00413400|BG000|Baseline|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
10870530|NCT00413400|BG001|Baseline|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
10870531|NCT00413400|BG002|Baseline|Total|Total of all reporting groups
10870532|NCT00413400|FG000|Participant Flow|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
10870533|NCT00413400|FG001|Participant Flow|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
10870534|NCT00413400|OG000|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
10870535|NCT00413400|OG001|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
10870536|NCT00413400|EG000|Reported Event|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
10870537|NCT00413400|EG001|Reported Event|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
10870538|NCT00413413|BG000|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
10870539|NCT00413413|BG001|Baseline|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
10870540|NCT00413413|BG002|Baseline|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
10870541|NCT00413413|BG003|Baseline|Total|Total of all reporting groups
10870542|NCT00413413|FG000|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
10870543|NCT00413413|FG001|Participant Flow|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
10870544|NCT00413413|FG002|Participant Flow|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
10870545|NCT00413413|OG000|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
10870546|NCT00413413|OG001|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
10870547|NCT00413413|OG002|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
10870548|NCT00413413|EG000|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
10870549|NCT00413413|EG001|Reported Event|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
10870550|NCT00413413|EG002|Reported Event|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
10870551|NCT00413478|BG000|Baseline|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
10870552|NCT00413478|FG000|Participant Flow|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
10870553|NCT00413478|OG000|Outcome|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
10870554|NCT00413478|EG000|Reported Event|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
10870555|NCT00413582|BG000|Baseline|Epidural Group|Epidural analgesia arm of study
10870556|NCT00413582|BG001|Baseline|PCA Group|IV narcotic analgesia arm of study
10870557|NCT00413582|BG002|Baseline|Total|Total of all reporting groups
10870558|NCT00413582|FG000|Participant Flow|Epidural Group|Epidural analgesia arm of study
10870559|NCT00413582|FG001|Participant Flow|PCA Group|IV narcotic analgesia arm of study
10870560|NCT00413582|OG000|Outcome|Epidural Group|Epidural analgesia arm of study
10870561|NCT00413582|OG001|Outcome|PCA Group|IV narcotic analgesia arm of study
10870562|NCT00413582|EG000|Reported Event|Epidural Group|Epidural analgesia arm of study
10870563|NCT00413582|EG001|Reported Event|PCA Group|IV narcotic analgesia arm of study
10870564|NCT00413634|BG000|Baseline|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
10870565|NCT00413634|BG001|Baseline|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
10870566|NCT00413634|BG002|Baseline|Total|Total of all reporting groups
10870567|NCT00413634|FG000|Participant Flow|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
10870568|NCT00413634|FG001|Participant Flow|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
10870569|NCT00413634|OG000|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
10870570|NCT00413634|OG001|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
10870571|NCT00413634|OG000|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
10870572|NCT00413634|OG001|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
10870573|NCT00413634|EG000|Reported Event|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
10870574|NCT00413634|EG001|Reported Event|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
10870575|NCT00413660|BG000|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
10870576|NCT00413660|BG001|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10870577|NCT00413660|BG002|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
10870578|NCT00413660|BG003|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
10870579|NCT00413660|BG004|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
10870580|NCT00413660|BG005|Baseline|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
10870581|NCT00413660|BG006|Baseline|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
10870582|NCT00413660|BG007|Baseline|Total|Total of all reporting groups
10870583|NCT00413660|FG000|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
10870584|NCT00413660|FG001|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10870585|NCT00413660|FG002|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
10870586|NCT00413660|FG003|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
10870587|NCT00413660|FG004|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
10870588|NCT00413660|FG005|Participant Flow|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
10870589|NCT00413660|FG006|Participant Flow|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
10870590|NCT00413660|FG007|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870591|NCT00413660|FG008|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870592|NCT00413660|FG009|Participant Flow|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870593|NCT00413660|FG010|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870594|NCT00413660|OG000|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
10870595|NCT00413660|OG001|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10870596|NCT00413660|OG002|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
10870597|NCT00413660|OG003|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
10870598|NCT00413660|OG004|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
10879251|NCT00456495|OG000|Outcome|Open Label Treatment|Patients will receive treatment every 2-4 weeks
10870599|NCT00413660|OG005|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
10870600|NCT00413660|OG006|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
10870601|NCT00413660|OG001|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870602|NCT00413660|OG002|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10870603|NCT00413660|OG003|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870604|NCT00413660|OG004|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
10870605|NCT00413660|OG005|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
10870606|NCT00413660|OG006|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
10870607|NCT00413660|OG007|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
10870608|NCT00413660|OG008|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870609|NCT00413660|OG009|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
10870610|NCT00413660|OG010|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870611|NCT00413660|EG000|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24.
10870612|NCT00413660|EG001|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|CP-690,550 1 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
10870613|NCT00413660|EG002|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24.
10870614|NCT00413660|EG003|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|CP-690,550 3 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
10870615|NCT00413660|EG004|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870616|NCT00413660|EG005|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24.
10870617|NCT00413660|EG006|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24.
10870618|NCT00413660|EG007|Reported Event|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 24.
10870619|NCT00413660|EG008|Reported Event|CP-690,550 20 mg to CP-690,550 5 mg (R)|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 12 followed by CP-690,550 5 mg tablet orally twice daily up to Week 24.
10870620|NCT00413660|EG009|Reported Event|Placebo|Matching placebo tablet orally twice daily up to Week 24.
10870621|NCT00413660|EG010|Reported Event|Placebo to CP-690,550 5 mg (R)|Matching placebo tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
10870622|NCT00413777|BG000|Baseline|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
10870623|NCT00413777|BG001|Baseline|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
10870624|NCT00413777|BG002|Baseline|Total|Total of all reporting groups
10870625|NCT00413777|FG000|Participant Flow|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
10870626|NCT00413777|FG001|Participant Flow|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
10870627|NCT00413777|OG000|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
10870628|NCT00413777|OG001|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
10870629|NCT00413777|EG000|Reported Event|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
10870630|NCT00413777|EG001|Reported Event|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
10870631|NCT00413894|BG000|Baseline|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
10870632|NCT00413894|FG000|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)|During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant's hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
10870633|NCT00413894|OG000|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
10870634|NCT00413894|OG000|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
10870635|NCT00413894|OG000|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A monthly administered IV at a dose decided by investigator according to participant's Hb values.
10870636|NCT00413894|OG000|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant's Hb values.
10870637|NCT00413894|EG000|Reported Event|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant's Hb values.
10870638|NCT00413920|BG000|Baseline|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
10870639|NCT00413920|BG001|Baseline|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
10870640|NCT00413920|BG002|Baseline|Total|Total of all reporting groups
10870641|NCT00413920|FG000|Participant Flow|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
11098927|NCT01578902|BG000|Baseline|All Patients|Inclusion criteria were men over 18 years of age with histologically confirmed diagnosis of adenocarcinoma of the prostate. Only patients with clinical stage T1-T2b (TNM 2002) [18] Gleason Sum 66 and PSA 610 ng/ml were eligible. Neoadjuvant androgen deprivation therapy (ADT) was allowed for cytoreduction. Patients were excluded if they had prior pelvic radiation therapy, a bleeding diathesis which precluded safe gold seed insertion, the presence of hip prosthesis or pelvic girth >40 cm. Lastly, prostate size >90cm3 on imaging or severe lower urinary tract symptoms (IPSS > 19)
10870642|NCT00413920|FG001|Participant Flow|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
10870643|NCT00413920|OG000|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
10870644|NCT00413920|OG001|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
10870645|NCT00413920|EG000|Reported Event|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
10870646|NCT00413920|EG001|Reported Event|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
10870647|NCT00413959|BG000|Baseline|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
10870648|NCT00413959|FG000|Participant Flow|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
10870649|NCT00413959|OG000|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
10870650|NCT00413959|EG000|Reported Event|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
10870651|NCT00414011|BG000|Baseline|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:~Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye~Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye~Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
10870652|NCT00414011|FG000|Participant Flow|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:~Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye~Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye~Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
10870653|NCT00414011|OG000|Outcome|Moxifloxacin|Moxifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
10870654|NCT00414011|OG001|Outcome|Gatifloxacin|Gatifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
11098928|NCT01578902|FG000|Participant Flow|Hypofractionated Radiation|"35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.~Hypofractionated radiotherapy: 35Gy/5 fractions/29 days"
11098929|NCT01578902|OG000|Outcome|Hypofractionated Radiation|"35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.~The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients."
10870655|NCT00414011|EG000|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
10870656|NCT00414050|BG000|Baseline|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
10870657|NCT00414050|BG001|Baseline|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
10870658|NCT00414050|BG002|Baseline|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
10870659|NCT00414050|BG003|Baseline|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
10870660|NCT00414050|BG004|Baseline|Total|Total of all reporting groups
10870661|NCT00414050|FG000|Participant Flow|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
10870662|NCT00414050|FG001|Participant Flow|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
10870663|NCT00414050|FG002|Participant Flow|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
10870664|NCT00414050|FG003|Participant Flow|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
10870665|NCT00414050|OG000|Outcome|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
10870666|NCT00414050|OG001|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
10870667|NCT00414050|OG002|Outcome|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
10870668|NCT00414050|OG003|Outcome|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
10870669|NCT00414050|EG000|Reported Event|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
10870670|NCT00414050|EG001|Reported Event|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
10870671|NCT00414050|EG002|Reported Event|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
10870672|NCT00414050|EG003|Reported Event|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
10870673|NCT00414076|BG000|Baseline|Letrozole|Letrozole only
10870674|NCT00414076|BG001|Baseline|Standard of Care|Standard of Care-Patients receive no treatment.
10870675|NCT00414076|BG002|Baseline|Total|Total of all reporting groups
10870676|NCT00414076|FG000|Participant Flow|Letrozole|Letrozole only
10870677|NCT00414076|FG001|Participant Flow|Standard of Care|Standard of Care-Patients receive no treatment.
10870678|NCT00414076|OG000|Outcome|Letrozole|"Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks.~Letrozole: 2.5 mg Tablet By Mouth Daily for 12 Weeks."
10870679|NCT00414076|OG001|Outcome|Standard of Care|Patients receive no treatment. Follow up every 3 months.
10870680|NCT00414076|EG000|Reported Event|Letrozole|"Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks.~Letrozole: 2.5 mg Tablet By Mouth Daily for 12 Weeks."
10870681|NCT00414076|EG001|Reported Event|Standard of Care|Patients receive no treatment. Follow up every 3 months.
10870682|NCT00414167|BG000|Baseline|Bupropion|"Bupropion~bupropion : 300 mg per day for 8 weeks"
10870683|NCT00414167|BG001|Baseline|Placebo|"Placebo~Placebo : Placebo"
10870684|NCT00414167|BG002|Baseline|Total|Total of all reporting groups
10870685|NCT00414167|FG000|Participant Flow|Bupropion (300 mg/d)|"Bupropion~bupropion : 300 mg per day for 8 weeks"
10870686|NCT00414167|FG001|Participant Flow|Placebo|"Placebo~Placebo : Placebo"
10870687|NCT00414167|OG000|Outcome|Bupropion|
10870688|NCT00414167|OG001|Outcome|Placebo|
11098930|NCT01578902|OG000|Outcome|Hypofractionated Radiation|"35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.~The co-primary endpoint (Grade 3+ acute genitourinary toxicity) was observed in 1% (1/84) patients."
10870689|NCT00414167|OG000|Outcome|Bupropion|"Bupropion~bupropion : 300 mg per day for 8 weeks"
10870690|NCT00414167|OG001|Outcome|Placebo|"Placebo~Placebo : Placebo"
10870691|NCT00414167|EG000|Reported Event|Bupropion|
10870692|NCT00414167|EG001|Reported Event|Placebo|
10870693|NCT00414206|BG000|Baseline|1% Mecamylamine|
10870694|NCT00414206|BG001|Baseline|0.3% Mecamylamine|
10870695|NCT00414206|BG002|Baseline|Placebo|
10870696|NCT00414206|BG003|Baseline|Total|Total of all reporting groups
10870697|NCT00414206|FG000|Participant Flow|1% Mecamylamine|
10870698|NCT00414206|FG001|Participant Flow|0.3% Mecamylamine|
10870699|NCT00414206|FG002|Participant Flow|Placebo|
10870700|NCT00414206|OG000|Outcome|1% Mecamylamine|
10870701|NCT00414206|OG001|Outcome|0.3% Mecamylamine|
10870702|NCT00414206|OG002|Outcome|Placebo|
10870703|NCT00414206|EG000|Reported Event|1% Mecamylamine|
10870704|NCT00414206|EG001|Reported Event|0.3% Mecamylamine|
10870705|NCT00414206|EG002|Reported Event|Placebo|
10870706|NCT00414271|BG000|Baseline|Docetaxel and Capecitabine in Gastric Cancer|Intravenous docetaxel 60 mg/m2 on day 1 and oral capecitabine 900 mg/m2 two times per day from day 1 to day 14 every 3 weeks for 2 cycles.
10870707|NCT00414271|FG000|Participant Flow|Docetaxel and Capecitabine in Gastric Cancer|Intravenous docetaxel 60 mg/m2 on day 1 and oral capecitabine 900 mg/m2 two times per day from day 1 to day 14 every 3 weeks for 2 cycles.
10870708|NCT00414271|OG000|Outcome|Open Label, Single Arm|Capecitabine, docetaxol
10870709|NCT00414271|EG000|Reported Event|Open Label, Single Arm|Capecitabine, docetaxol
10870710|NCT00414310|BG000|Baseline|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
10870711|NCT00414310|BG001|Baseline|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
10870712|NCT00414310|BG002|Baseline|Total|Total of all reporting groups
10870713|NCT00414310|FG000|Participant Flow|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
10870714|NCT00414310|FG001|Participant Flow|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
10870715|NCT00414310|OG000|Outcome|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
10870716|NCT00414310|OG001|Outcome|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
10870717|NCT00414310|OG000|Outcome|Decitabine|"Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.~Decitabine: 20 mg/m^2 IV over 1 hour daily for 5 days."
10870718|NCT00414310|OG001|Outcome|Decitabine + Valproic Acid|"Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.~Decitabine: 20 mg/m^2 IV over 1 hour daily for 5 days.~Valproic Acid: 50 mg/kg orally daily for 7 days"
10870719|NCT00414310|EG000|Reported Event|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
10870720|NCT00414310|EG001|Reported Event|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
10870721|NCT00414388|BG000|Baseline|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
10870722|NCT00414388|FG000|Participant Flow|Single Agent Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m^2 and mitoxantrone was given at 12 mg/m^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.
10870723|NCT00414388|OG000|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
10870724|NCT00414388|OG000|Outcome|Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (Docetaxel or Mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m2 and Mitoxantrone was given at 12 mg/m2, both once every 21 days and both combined with Prednisone at 5mg twice daily. A maximum of 6 cycles of Sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive Sorafenib monotherapy until disease progression.
10870725|NCT00414388|EG000|Reported Event|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
10870726|NCT00414440|BG000|Baseline|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
10870727|NCT00414440|BG001|Baseline|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
10870728|NCT00414440|BG002|Baseline|Total|Total of all reporting groups
11098931|NCT01578902|OG000|Outcome|Hypofractionated Radiation|"35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.~Hypofractionated radiotherapy: 35Gy/5 fractions/29 days"
10870729|NCT00414440|FG000|Participant Flow|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
10870730|NCT00414440|FG001|Participant Flow|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
10870731|NCT00414440|OG000|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
10870732|NCT00414440|OG001|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
10870733|NCT00414440|EG000|Reported Event|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
10870734|NCT00414440|EG001|Reported Event|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses
10870735|NCT00414466|BG000|Baseline|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
11098932|NCT01578902|OG000|Outcome|Hypofractionated Radiotherapy Using SABR|"Stereotactic radiation: 35Gy in 5 fractions over 29 days~Stereotactic ablative body radiotherapy: 35Gy/5 fractions/29 days"
10870736|NCT00414466|BG001|Baseline|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870737|NCT00414466|BG002|Baseline|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870738|NCT00414466|BG003|Baseline|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870739|NCT00414466|BG004|Baseline|Total|Total of all reporting groups
10870740|NCT00414466|FG000|Participant Flow|1 Placebo (0mg/Day)|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
11098933|NCT01578902|EG000|Reported Event|Hypofractionated Radiation|"35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.~The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients."
10870741|NCT00414466|FG001|Participant Flow|2 Gabapentin Low (1mg/Day)|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
11098934|NCT01578980|BG000|Baseline|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
10870742|NCT00414466|FG002|Participant Flow|3 Gabapentin Medium (6mg/Day)|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870743|NCT00414466|FG003|Participant Flow|4 Gabapentin High (30mg/Day)|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870744|NCT00414466|OG000|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
10870745|NCT00414466|OG001|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870746|NCT00414466|OG002|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870747|NCT00414466|OG003|Outcome|4 Gabapentin High|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870748|NCT00414466|OG001|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870749|NCT00414466|OG002|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870750|NCT00414466|OG003|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870751|NCT00414466|EG000|Reported Event|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
10870752|NCT00414466|EG001|Reported Event|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870753|NCT00414466|EG002|Reported Event|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870754|NCT00414466|EG003|Reported Event|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
10870755|NCT00414518|BG000|Baseline|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
10870756|NCT00414518|BG001|Baseline|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
10870757|NCT00414518|BG002|Baseline|Total|Total of all reporting groups
10870758|NCT00414518|FG000|Participant Flow|Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
10870759|NCT00414518|FG001|Participant Flow|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
10870760|NCT00414518|OG000|Outcome|12 Week Treatment Arm Followed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
10870761|NCT00414518|OG001|Outcome|CD4 T Cell Guided Therapyh|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
10870762|NCT00414518|OG000|Outcome|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
10870763|NCT00414518|OG001|Outcome|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
10870764|NCT00414518|OG000|Outcome|12 Week Treatment Folllowed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
10870765|NCT00414518|OG001|Outcome|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
10870766|NCT00414518|EG000|Reported Event|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
10870767|NCT00414518|EG001|Reported Event|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
10870768|NCT00414544|BG000|Baseline|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
10870769|NCT00414544|FG000|Participant Flow|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
10870770|NCT00414544|OG000|Outcome|CosmetaLife|CosmetaLife injected nasolabial fold side
10870771|NCT00414544|OG001|Outcome|Restylane (Control)|Restylane (Control) injected nasolabial fold contralateral side
10870772|NCT00414544|EG000|Reported Event|CosmetaLife|
10870773|NCT00414544|EG001|Reported Event|Restylane (Control)|
10870774|NCT00414596|BG000|Baseline|DRX Group|Patients using the device DRX9000™.
10870775|NCT00414596|FG000|Participant Flow|DRX Group|Patients using the device DRX9000™.
10870776|NCT00414596|OG000|Outcome|DRX Group|Patients using the device DRX9000™.
10870777|NCT00414596|EG000|Reported Event|DRX Group|Patients using the device DRX9000™.
10870778|NCT00414609|BG000|Baseline|Placebo|Placebo for 36 weeks once daily in the morning
10870779|NCT00414609|BG001|Baseline|Aliskiren|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
10870780|NCT00414609|BG002|Baseline|Total|Total of all reporting groups
10870781|NCT00414609|FG000|Participant Flow|Placebo_Core|Placebo for 36 weeks once daily in the morning
10870782|NCT00414609|FG001|Participant Flow|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
10870783|NCT00414609|FG002|Participant Flow|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
10870784|NCT00414609|OG000|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
10870785|NCT00414609|OG001|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
10870786|NCT00414609|OG000|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
10870787|NCT00414609|OG000|Outcome|Aliskiren_Extension|150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study.
10870788|NCT00414609|EG000|Reported Event|Placebo_core|Placebo for 36 weeks once daily in the morning
10870789|NCT00414609|EG001|Reported Event|Aliskiren_core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
10870790|NCT00414609|EG002|Reported Event|Aliskiren_extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
10870791|NCT00414635|BG000|Baseline|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
10870792|NCT00414635|BG001|Baseline|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
10870793|NCT00414635|BG002|Baseline|Total|Total of all reporting groups
11098935|NCT01578980|FG000|Participant Flow|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
10870794|NCT00414635|FG000|Participant Flow|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
10870795|NCT00414635|FG001|Participant Flow|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
10870796|NCT00414635|OG000|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
10870797|NCT00414635|OG001|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
10870798|NCT00414635|EG000|Reported Event|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
10870799|NCT00414635|EG001|Reported Event|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
10870800|NCT00414661|BG000|Baseline|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
11098936|NCT01578980|OG000|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.~42 hours total: 14 hours in open-loop 28 hours in closed-loop"
10870801|NCT00414661|BG001|Baseline|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
10870802|NCT00414661|BG002|Baseline|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
10870803|NCT00414661|BG003|Baseline|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
10870804|NCT00414661|BG004|Baseline|Total|Total of all reporting groups
10870805|NCT00414661|FG000|Participant Flow|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
10870806|NCT00414661|FG001|Participant Flow|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
10870807|NCT00414661|FG002|Participant Flow|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
10870808|NCT00414661|FG003|Participant Flow|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
10870809|NCT00414661|OG000|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
10870810|NCT00414661|OG001|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
10870811|NCT00414661|OG002|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
10870812|NCT00414661|OG003|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
10870813|NCT00414661|EG000|Reported Event|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
10870814|NCT00414661|EG001|Reported Event|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
10870815|NCT00414661|EG002|Reported Event|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
10870816|NCT00414661|EG003|Reported Event|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
10870817|NCT00414700|BG000|Baseline|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
10870818|NCT00414700|BG001|Baseline|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
10870819|NCT00414700|BG002|Baseline|Total|Total of all reporting groups
10870820|NCT00414700|FG000|Participant Flow|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
10870821|NCT00414700|FG001|Participant Flow|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
11098937|NCT01578980|EG000|Reported Event|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
10870822|NCT00414700|OG000|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
10870823|NCT00414700|OG001|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
10870824|NCT00414700|EG000|Reported Event|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
10870825|NCT00414700|EG001|Reported Event|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
10870826|NCT00414726|BG000|Baseline|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
10870827|NCT00414726|BG001|Baseline|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
10870828|NCT00414726|BG002|Baseline|Total|Total of all reporting groups
10870829|NCT00414726|FG000|Participant Flow|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
10870830|NCT00414726|FG001|Participant Flow|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
10870831|NCT00414726|OG000|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
10870832|NCT00414726|OG001|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
10870833|NCT00414726|EG000|Reported Event|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
10870834|NCT00414726|EG001|Reported Event|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
10870835|NCT00414765|BG000|Baseline|mRCC Group|Participants with mRCC were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
10870836|NCT00414765|BG001|Baseline|Metastatic Melanoma Group|Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
10870837|NCT00414765|BG002|Baseline|Total|Total of all reporting groups
10870838|NCT00414765|FG000|Participant Flow|mRCC Group|Participants with metastatic renal cell carcinoma (mRCC) were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
10870839|NCT00414765|FG001|Participant Flow|Metastatic Melanoma Group|Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
10870840|NCT00414765|OG000|Outcome|mRCC Group|Participants with mRCC were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
10870841|NCT00414765|OG001|Outcome|Metastatic Melanoma Group|Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
10870842|NCT00414765|EG000|Reported Event|mRCC|mRCC
10870843|NCT00414765|EG001|Reported Event|Metastatic Melanoma|Metastatic Melanoma
10870844|NCT00414817|BG000|Baseline|Automated Phone-Based Refill Reminders|Intervention arm participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
10870845|NCT00414817|BG001|Baseline|Usual Care|usual care participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
10870846|NCT00414817|BG002|Baseline|Total|Total of all reporting groups
10870847|NCT00414817|FG000|Participant Flow|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
10870848|NCT00414817|FG001|Participant Flow|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
10870849|NCT00414817|OG000|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
10870850|NCT00414817|OG001|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
10870851|NCT00414817|EG000|Reported Event|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
10870852|NCT00414817|EG001|Reported Event|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
10870853|NCT00414908|BG000|Baseline|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
10870854|NCT00414908|BG001|Baseline|Placebo (DB)|Placebo group given during the Double-Blind period
10870855|NCT00414908|BG002|Baseline|Total|Total of all reporting groups
10870856|NCT00414908|FG000|Participant Flow|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
10870857|NCT00414908|FG001|Participant Flow|Placebo (DB)|Placebo group given during the Double-Blind period
10870858|NCT00414908|OG000|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
10870859|NCT00414908|OG001|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
10870860|NCT00414908|OG000|Outcome|Pancrelipase (OL)|Pancrelipase delayed during Open-label. Dosing is directed by the investigator.
10870861|NCT00414908|EG000|Reported Event|Pancrelipase (DB)|Pancrelipase delayed release capsules meaning the treatment received during the 7-days double-blind period
10870862|NCT00414908|EG001|Reported Event|Placebo (DB)|Placebo group meaning the treatment received during the 7-days double-blind period
10870863|NCT00414908|EG002|Reported Event|Pancrelipase (OL)|Pancrelipase delayed capsules received by the patients during the 6-month Open Label. The dosing was directed by the investigator.
10870864|NCT00414960|BG000|Baseline|Enzastaurin|Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
10870865|NCT00414960|BG001|Baseline|Placebo|Treatment with placebo po QD appearing identical to enzastaurin.
10870866|NCT00414960|BG002|Baseline|Total|Total of all reporting groups
10870867|NCT00414960|FG000|Participant Flow|Enzastaurin|Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
10870868|NCT00414960|FG001|Participant Flow|Placebo|Treatment with placebo po QD appearing identical to enzastaurin.
10870869|NCT00414960|OG000|Outcome|Enzastaurin|Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
10870870|NCT00414960|OG001|Outcome|Placebo|Treatment with placebo po QD appearing identical to enzastaurin.
10870871|NCT00414960|EG000|Reported Event|Enzastaurin|Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
10870872|NCT00414960|EG001|Reported Event|Placebo|Treatment with placebo po QD appearing identical to enzastaurin.
10879252|NCT00456495|OG000|Outcome|Open Label Treatment|Patients will receive treatment every 2-4 weeks. To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate the number of clock hours of corneal neovascularization, from baseline to month 12, and 24. To report on the number of patients with a decrease in corneal neovascularization.
10879253|NCT00456495|EG000|Reported Event|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
10879254|NCT00456508|BG000|Baseline|Treatment|DX-88 (ecallantide)
10879255|NCT00456508|FG000|Participant Flow|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
10879256|NCT00456508|OG000|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
10879257|NCT00456508|EG000|Reported Event|Treatment|DX-88 (ecallantide)
10879258|NCT00456521|BG000|Baseline|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
10879259|NCT00456521|BG001|Baseline|Placebo|Placebo
10879260|NCT00456521|BG002|Baseline|Total|Total of all reporting groups
10879261|NCT00456521|FG000|Participant Flow|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
10879262|NCT00456521|FG001|Participant Flow|Placebo|Placebo
10879263|NCT00456521|OG000|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
10879264|NCT00456521|OG001|Outcome|Placebo|Placebo
10879265|NCT00456521|OG000|Outcome|NB32|"Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group behavioral lifestyle modification counseling~naltrexone SR/bupropion SR combination~Intensive group lifestyle modification counseling: Group lifestyle modification counseling"
10879266|NCT00456521|EG000|Reported Event|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
10879267|NCT00456521|EG001|Reported Event|Placebo|Placebo
10870873|NCT00414973|BG000|Baseline|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
10870874|NCT00414973|BG001|Baseline|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
10870875|NCT00414973|BG002|Baseline|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
10870876|NCT00414973|BG003|Baseline|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
10870877|NCT00414973|BG004|Baseline|Total|Total of all reporting groups
10870878|NCT00414973|FG000|Participant Flow|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
10870879|NCT00414973|FG001|Participant Flow|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
10870880|NCT00414973|FG002|Participant Flow|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
10870881|NCT00414973|FG003|Participant Flow|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
10870882|NCT00414973|OG000|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
10870883|NCT00414973|OG001|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
10870884|NCT00414973|OG000|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
10870885|NCT00414973|OG001|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
10870886|NCT00414973|EG000|Reported Event|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
10870887|NCT00414973|EG001|Reported Event|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
10870888|NCT00414973|EG002|Reported Event|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
10870889|NCT00414973|EG003|Reported Event|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
10870890|NCT00415051|BG000|Baseline|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
10870891|NCT00415051|FG000|Participant Flow|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
10870892|NCT00415051|OG000|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
10870893|NCT00415051|EG000|Reported Event|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
10870894|NCT00415168|BG000|Baseline|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
10870895|NCT00415168|FG000|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
10870896|NCT00415168|OG000|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
11098938|NCT01578993|BG000|Baseline|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
11098939|NCT01578993|FG000|Participant Flow|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
10870897|NCT00415168|EG000|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
10870898|NCT00415194|BG000|Baseline|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
10870899|NCT00415194|BG001|Baseline|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
10870900|NCT00415194|BG002|Baseline|Total|Total of all reporting groups
10870901|NCT00415194|FG000|Participant Flow|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
10870902|NCT00415194|FG001|Participant Flow|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
10870903|NCT00415194|OG000|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
10879268|NCT00456547|BG000|Baseline|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
11098940|NCT01578993|OG000|Outcome|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
10870904|NCT00415194|OG001|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
10870905|NCT00415194|EG000|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meter square (mg/m2) administered intravenously (IV) plus cisplatin 75 mg/m2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
10870906|NCT00415194|EG001|Reported Event|Placebo/Cisplatin|Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
10870907|NCT00415363|BG000|Baseline|Enzastaurin|Enzastaurin delivered as 1125 mg loading dose then 500 mg, oral, daily, until disease progression
10870908|NCT00415363|BG001|Baseline|Placebo|Placebo delivered as identical in appearance oral dose, daily.
10870909|NCT00415363|BG002|Baseline|Total|Total of all reporting groups
10870910|NCT00415363|FG000|Participant Flow|Enzastaurin|Enzastaurin delivered as 1125 mg loading dose then 500 mg, oral, daily, until disease progression
10870911|NCT00415363|FG001|Participant Flow|Placebo|Placebo delivered as identical in appearance oral dose, daily.
10870912|NCT00415363|OG000|Outcome|Enzastaurin|Enzastaurin delivered as 1125 mg loading dose then 500 mg, oral, daily, until disease progression
11098941|NCT01578993|EG000|Reported Event|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
10870913|NCT00415363|OG001|Outcome|Placebo|Placebo delivered as identical in appearance oral dose, daily.
10870914|NCT00415363|OG000|Outcome|Enzastaurin|Enzastaurin delivered as 1125 mg loading dose then 500 mg, oral, daily, until disease progression.
10870915|NCT00415363|EG000|Reported Event|Enzastaurin|Enzastaurin delivered as 1125 mg loading dose then 500 mg, oral, daily, until disease progression
10870916|NCT00415363|EG001|Reported Event|Placebo|Placebo delivered as identical in appearance oral dose, daily.
10870917|NCT00415493|BG000|Baseline|Cases|non-allergic rhinitis subjects
10870918|NCT00415493|BG001|Baseline|Controls|normal subjects
10870919|NCT00415493|BG002|Baseline|Total|Total of all reporting groups
10870920|NCT00415493|FG000|Participant Flow|Cold-dry Air Followed by Warm-moist Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Cold-dry air followed (on a separate day) by Warm-moist air. Exposures lasted 15 minutes, with a one-hour follow-up period.
10870921|NCT00415493|FG001|Participant Flow|Warm-moist Air Followed by Cold-dry Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Warm-moist air followed (on a separate day) by Cold-dry air. Exposures lasted 15 minutes, with a one-hour follow-up period.
10870922|NCT00415493|OG000|Outcome|Cases|non-allergic rhinitis subjects
10870923|NCT00415493|OG001|Outcome|Controls|normal subjects
10870924|NCT00415493|EG000|Reported Event|Cases|non-allergic rhinitis subjects
10870925|NCT00415493|EG001|Reported Event|Controls|normal subjects
10870926|NCT00415506|BG000|Baseline|Scleritis|Subjects with Scleritis
10870927|NCT00415506|BG001|Baseline|Orbital Inflammation|Subjects with Orbital Inflammation
10870928|NCT00415506|BG002|Baseline|Total|Total of all reporting groups
10870929|NCT00415506|FG000|Participant Flow|Scleritis|Patients with non-infectious scleritis and is a phase II, randomized, double-blinded, prospective clinical trial of two different doses of rituximab to compare the safety and efficacy of these 2 doses. Patients will be randomized to either 500 mg or 1000 mg of rituximab administered intravenously two weeks apart.
10870930|NCT00415506|FG001|Participant Flow|Orbital Inflammation|Patients with non-infectious orbital inflammatory disease, and is a phase I, prospective clinical trial to examine the safety of the 2 infusions of rituximab intravenously, 2 weeks apart, in the treatment of non-infectious orbital inflammation. The first 5 patients will receive 1000 mg of rituximab at each infusion, any additional patients will be randomized to receive either 500 mg or 1000 mg of rituximab.
10870931|NCT00415506|OG000|Outcome|Scleritis|Subjects with Scleritis
10870932|NCT00415506|OG001|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
10870933|NCT00415506|EG000|Reported Event|Orbital Inflammation|Subjects with Orbital Inflammation
10870934|NCT00415506|EG001|Reported Event|Scleritis|Subjects with Scleritis
10870935|NCT00415519|BG000|Baseline|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
10870936|NCT00415519|BG001|Baseline|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
10870937|NCT00415519|BG002|Baseline|Total|Total of all reporting groups
10870938|NCT00415519|FG000|Participant Flow|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
10870939|NCT00415519|FG001|Participant Flow|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
10870940|NCT00415519|OG000|Outcome|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
10870941|NCT00415519|OG001|Outcome|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
10870942|NCT00415519|EG000|Reported Event|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
10870943|NCT00415519|EG001|Reported Event|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
10870944|NCT00415532|BG000|Baseline|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
10870945|NCT00415532|BG001|Baseline|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
10870946|NCT00415532|BG002|Baseline|Total|Total of all reporting groups
11098942|NCT01579006|BG000|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
11098943|NCT01579006|FG000|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), who have had an inadequate response (or were intolerant) to treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
10870947|NCT00415532|FG000|Participant Flow|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
10870948|NCT00415532|FG001|Participant Flow|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
10870949|NCT00415532|OG000|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
10870950|NCT00415532|OG001|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
10870951|NCT00415532|EG000|Reported Event|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
10870952|NCT00415532|EG001|Reported Event|AMG 531|
10870953|NCT00415597|BG000|Baseline|ALO-01|
10870954|NCT00415597|FG000|Participant Flow|ALO-01|
10870955|NCT00415597|OG000|Outcome|ALO-01|
10870956|NCT00415597|EG000|Reported Event|ALO-01|
10870957|NCT00415610|BG000|Baseline|Tier 1|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
10870958|NCT00415610|BG001|Baseline|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 140 to 170 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
10870959|NCT00415610|BG002|Baseline|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 110 to 140 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
10870960|NCT00415610|BG003|Baseline|Total|Total of all reporting groups
10870961|NCT00415610|FG000|Participant Flow|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
10870962|NCT00415610|FG001|Participant Flow|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
10870963|NCT00415610|FG002|Participant Flow|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
10870964|NCT00415610|OG000|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
10870965|NCT00415610|OG001|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
10870966|NCT00415610|OG002|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
10870967|NCT00415610|EG000|Reported Event|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
10870968|NCT00415610|EG001|Reported Event|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
10870969|NCT00415610|EG002|Reported Event|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
10870970|NCT00415636|BG000|Baseline|LY2603618 40 mg/m^2 (4.5-hour Infusion)|LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
10870971|NCT00415636|BG001|Baseline|LY2603618 40 mg/m^2 (1-hour Infusion)|Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
10870972|NCT00415636|BG002|Baseline|LY2603618 70 mg/m^2|Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
11098944|NCT01579006|OG000|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
11098945|NCT01579006|EG000|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who had been receiving TCZ in the past and in whom the attending physician decided to start treatment with TCZ at the time of recruitment (according to the local label) were observed for 6 months.
11098946|NCT01579045|BG000|Baseline|Overall Subjects|All subjects who were enrolled, and completed the study.
11098947|NCT01579045|FG000|Participant Flow|All Subjects|All subjects who were enrolled.
11098948|NCT01579045|OG000|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
11098949|NCT01579045|OG001|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
10870973|NCT00415636|BG003|Baseline|LY2603618 105 mg/m^2|LY2603618 105 mg/m^2 administered over the duration of 1 hour.
10870974|NCT00415636|BG004|Baseline|LY2603618 150 mg/m^2|LY2603618 150 mg/m^2 administered over the duration of 1 hour.
10870975|NCT00415636|BG005|Baseline|LY2603618 195 mg/m^2|LY2603618 195 mg/m^2 administered over the duration of 1 hour.
10870976|NCT00415636|BG006|Baseline|Total|Total of all reporting groups
10870977|NCT00415636|FG000|Participant Flow|LY2603618 40 mg/m^2 (4.5-hour Infusion)|LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
10870978|NCT00415636|FG001|Participant Flow|LY2603618 40 mg/m^2 (1-hour Infusion)|Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
10870979|NCT00415636|FG002|Participant Flow|LY2603618 70 mg/m^2|Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
10870980|NCT00415636|FG003|Participant Flow|LY2603618 105 mg/m^2|LY2603618 105 mg/m^2 administered over the duration of 1 hour.
10870981|NCT00415636|FG004|Participant Flow|LY2603618 150 mg/m^2|LY2603618 150 mg/m^2 administered over the duration of 1 hour.
10870982|NCT00415636|FG005|Participant Flow|LY2603618 195 mg/m^2|LY2603618 195 mg/m^2 administered over the duration of 1 hour.
10870983|NCT00415636|OG000|Outcome|LY2603618 40 mg/m^2 (4.5-hour Infusion)|4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m^2
10870984|NCT00415636|OG001|Outcome|LY2603618 40 mg/m^2 (1-hour Infusion)|1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2
10870985|NCT00415636|OG002|Outcome|LY2603618 70 mg/m^2|1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2
10870986|NCT00415636|OG003|Outcome|LY2603618 105 mg/m^2|1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2
10870987|NCT00415636|OG004|Outcome|LY2603618 150 mg/m^2|1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2
10870988|NCT00415636|OG005|Outcome|LY2603618 195 mg/m^2|1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2
10870989|NCT00415636|OG000|Outcome|LY2603618 40 mg/m^2 (4.5-hour Infusion)|4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
10870990|NCT00415636|OG001|Outcome|LY2603618 40 mg/m^2 (1-hour Infusion)|1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
10870991|NCT00415636|OG002|Outcome|LY2603618 70 mg/m^2|1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
10870992|NCT00415636|OG003|Outcome|LY2603618 105 mg/m^2|1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
10870993|NCT00415636|OG004|Outcome|LY2603618 150 mg/m^2|1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
10870994|NCT00415636|OG005|Outcome|LY2603618 195 mg/m^2|1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
10870995|NCT00415636|OG000|Outcome|LY2603618 40 mg/m^2 (4.5 Hours)|4.5-hour IV infusion of IC83/LY2603618 40 mg/m^2
10870996|NCT00415636|OG001|Outcome|LY2603618 40 mg/m^2 (1 Hour)|1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2
10870997|NCT00415636|EG000|Reported Event|LY2603618 40 mg/m^2 (4.5-hour Infusion)|LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
10870998|NCT00415636|EG001|Reported Event|LY2603618 40 mg/m^2 (1-hour Infusion)|Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
10870999|NCT00415636|EG002|Reported Event|LY2603618 70 mg/m^2|Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
11098950|NCT01579045|OG002|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
11098951|NCT01579045|OG003|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
10871000|NCT00415636|EG003|Reported Event|LY2603618 105 mg/m^2|LY2603618 105 mg/m^2 administered over the duration of 1 hour.
10871001|NCT00415636|EG004|Reported Event|LY2603618 150 mg/m^2|LY2603618 150 mg/m^2 administered over the duration of 1 hour.
10871002|NCT00415636|EG005|Reported Event|LY2603618 195 mg/m^2|LY2603618 195 mg/m^2 administered over the duration of 1 hour.
10871003|NCT00415857|BG000|Baseline|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
10871004|NCT00415857|BG001|Baseline|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
10871005|NCT00415857|BG002|Baseline|Total|Total of all reporting groups
10871006|NCT00415857|FG000|Participant Flow|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
10871007|NCT00415857|FG001|Participant Flow|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
10871008|NCT00415857|OG000|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
10871009|NCT00415857|OG001|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
10871010|NCT00415857|EG000|Reported Event|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
10871011|NCT00415857|EG001|Reported Event|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
10871012|NCT00415870|BG000|Baseline|Control: Enhanced Usual Care|Enhanced usual care
10871013|NCT00415870|BG001|Baseline|PACE: Intervention - SMS Messages and Lifestyle Counseling|Received text messages and counseling calls
10871014|NCT00415870|BG002|Baseline|Total|Total of all reporting groups
10871015|NCT00415870|FG000|Participant Flow|Control|Enhanced Usual Care
10871016|NCT00415870|FG001|Participant Flow|PACE|"Received text messages and counseling calls~Food Monitoring : Food Monitoring~Text Message : Text Message~Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device~Diet Goals via Cell Phone : Diet Goals via Cell Phone~Weekly Weighing : Weekly Weighing~Printed Material : Printed Material"
10871017|NCT00415870|OG000|Outcome|Control:Enhanced Usual Care|Enhanced Usual Care
10871018|NCT00415870|OG001|Outcome|PACE: Intervention - SMS Messages|Received text messages and counseling calls
10871019|NCT00415870|EG000|Reported Event|Control|Enhanced Usual Care
10871020|NCT00415870|EG001|Reported Event|PACE|Received text messages and counseling calls
10871021|NCT00415909|BG000|Baseline|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
10871022|NCT00415909|FG000|Participant Flow|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy. Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~T Acute Lymphoblastic Leukemia/Lymphoma (TALL)-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
10871023|NCT00415909|OG000|Outcome|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
10871024|NCT00415909|EG000|Reported Event|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
10871025|NCT00416078|BG000|Baseline|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
10871026|NCT00416078|BG001|Baseline|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year customary care
10871027|NCT00416078|BG002|Baseline|Total|Total of all reporting groups
10871028|NCT00416078|FG000|Participant Flow|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
10871029|NCT00416078|FG001|Participant Flow|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
10871030|NCT00416078|OG000|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
10871031|NCT00416078|OG001|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
10871032|NCT00416078|EG000|Reported Event|Caregiver Website Support|caregiver access to website support for 6 months embedded in one year of customary care
10871033|NCT00416078|EG001|Reported Event|Caregiver Brief Supportive Phone Calls|caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
10871034|NCT00416182|BG000|Baseline|Pulmozyme (Dornase Alfa)|2.5 mg/2.5 mL of intranasal Pulmozyme
10871035|NCT00416182|BG001|Baseline|Placebo|2.5 mL of placebo comparator
10871036|NCT00416182|BG002|Baseline|Total|Total of all reporting groups
10871037|NCT00416182|FG000|Participant Flow|Pulmozyme (Dornase Alfa)|2.5 mg/2.5mL of Pulmozyme administered intranasally once daily
10871038|NCT00416182|FG001|Participant Flow|Placebo|2.5mg/2.5mL placebo administered intranasally once daily
10871039|NCT00416182|OG000|Outcome|Pulmozyme|Patients receiving 2.5 mg intranasal Pulmozyme once daily
10871040|NCT00416182|OG001|Outcome|Placebo|Patients receiving intranasal placebo once daily
10871041|NCT00416182|OG000|Outcome|Pulmozyme|endoscopic photos of sinuses by ENT surgeon independently and blindly scored by two surgeons with scale of 0,1,2 to indicate severity of disease
10871042|NCT00416182|OG001|Outcome|Placebo|endoscopic photos of sinuses by ENT surgeon, independently and blindly scored by two surgeons. Scores of 0,1,2 based on disease severity.
10871043|NCT00416182|OG000|Outcome|Pulmozyme|Scores from the Chronic Sinusitis Survey
10871044|NCT00416182|OG001|Outcome|Placebo|Scores from the Chronic Sinusitis Survey recorded
10871045|NCT00416182|OG000|Outcome|Pulmozyme|Percent predicted for forced expiratory volume in 1 second recorded
10871046|NCT00416182|OG001|Outcome|Placebo|Percent predicted forced expiratory volume in 1 second recorded
10871047|NCT00416182|EG000|Reported Event|Pulmozyme|patients receiving once daily intranasal Pulmozyme
10871048|NCT00416182|EG001|Reported Event|Placebo|patients receiving once daily intranasal placebo
10871049|NCT00416195|BG000|Baseline|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
10871050|NCT00416195|BG001|Baseline|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
10871051|NCT00416195|BG002|Baseline|Total|Total of all reporting groups
10871052|NCT00416195|FG000|Participant Flow|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
10871053|NCT00416195|FG001|Participant Flow|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
10871054|NCT00416195|OG000|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
10871055|NCT00416195|OG001|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
10871056|NCT00416195|EG000|Reported Event|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
10871057|NCT00416195|EG001|Reported Event|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
10871058|NCT00416312|BG000|Baseline|Conventional & Patient-specific Dosimetry|Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
10871059|NCT00416312|FG000|Participant Flow|Conventional & Patient-specific Dosimetry|Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
10871060|NCT00416312|OG000|Outcome|Conventional & Patient-specific Dosimetry|Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
10871061|NCT00416312|EG000|Reported Event|Conventional & Patient-specific Dosimetry|Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
10871062|NCT00416455|BG000|Baseline|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10871063|NCT00416455|BG001|Baseline|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10871064|NCT00416455|BG002|Baseline|Total|Total of all reporting groups
10871065|NCT00416455|FG000|Participant Flow|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10879269|NCT00456547|BG001|Baseline|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
10879270|NCT00456547|BG002|Baseline|Total|Total of all reporting groups
10871066|NCT00416455|FG001|Participant Flow|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10871067|NCT00416455|OG000|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10871068|NCT00416455|OG001|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10871069|NCT00416455|OG000|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients.
10871070|NCT00416455|OG001|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
10871071|NCT00416455|OG000|Outcome|Cervical Cancer Patients - Sensitivity of CT|CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients.
10871072|NCT00416455|OG001|Outcome|Endometrial Cancer Cohort - Sensitivity of CT|CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after CT scan. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
10871073|NCT00416455|OG000|Outcome|Cervical Cancer Patients - Sensitivity of CT|CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after CT scan
10871074|NCT00416455|OG001|Outcome|Endometrial Cancer Cohort - Sensitivity of CT|CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after CT scan
10871075|NCT00416455|OG000|Outcome|Cervical Cancer Patients-Sensitivity of CT|CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after CT scan
10871076|NCT00416455|OG001|Outcome|Endometrial Cancer Patients|CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10871077|NCT00416455|OG000|Outcome|Number of Participants With a Maximum Grade of 3 or Higher Dur|Number of participants with a maximum grade of 3 or higher during treatment period and up to 30 days after stopping study treatment.
10871078|NCT00416455|OG000|Outcome|Cause of Delay in the Initiation of Chemo-radiation Therapy mo|All Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy who experienced a delay in the initiation of chemo-radiation therapy
10871079|NCT00416455|OG000|Outcome|Causes of Interruption in Radiation Therapy|Number of participants with reasons of interruption in radiation therapy
10871080|NCT00416455|EG000|Reported Event|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10871081|NCT00416455|EG001|Reported Event|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
10871082|NCT00416494|BG000|Baseline|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
10871083|NCT00416494|BG001|Baseline|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
10871084|NCT00416494|BG002|Baseline|Total|Total of all reporting groups
10871085|NCT00416494|FG000|Participant Flow|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
10871086|NCT00416494|FG001|Participant Flow|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
10871087|NCT00416494|OG000|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
10871088|NCT00416494|OG001|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
10871089|NCT00416494|EG000|Reported Event|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
10879271|NCT00456547|FG000|Participant Flow|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
10871090|NCT00416494|EG001|Reported Event|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
10871091|NCT00416520|BG000|Baseline|MCI-196 (Open-label Period)|
10871092|NCT00416520|BG001|Baseline|Sevelamer (Open-label Period)|
10871093|NCT00416520|BG002|Baseline|Total|Total of all reporting groups
10871094|NCT00416520|FG000|Participant Flow|MCI-196 (Open-label Period)|"3, 6, 9, 12, or 15g/day as titrated~There was a gap of 3 subjects between STARTED and Overall Number of Baseline Participants.~Two subjects were randomised to receive MCI-196, but did not take study medication. These 2 subjects were excluded from Baseline Participants of MCI-196 group.~In addition, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
10871095|NCT00416520|FG001|Participant Flow|Sevelamer (Open-label Period)|"2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated~There was a gap of 2 subjects between STARTED and Overall Number of Baseline Participants.~Three subjects in Sevelamer group were randomised in error and did not take any study medication. These 3 subjects were excluded from Baseline Participants of Sevelamer group.~However, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
10871096|NCT00416520|FG002|Participant Flow|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
10871097|NCT00416520|FG003|Participant Flow|Placebo (Placebo-controlled Withdrawal Period)|"dose level at the end of dose titration in the flexible dose period~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants One subject did not take any study medication and excluded from Baseline Participants."
10871098|NCT00416520|OG000|Outcome|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
10871099|NCT00416520|OG001|Outcome|Placebo (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
10871100|NCT00416520|OG000|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
10871101|NCT00416520|OG001|Outcome|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
10871102|NCT00416520|EG000|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
10871103|NCT00416520|EG001|Reported Event|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
10871104|NCT00416520|EG002|Reported Event|MCI-196 (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
10871105|NCT00416520|EG003|Reported Event|Placebo (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
10871106|NCT00416572|BG000|Baseline|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.
10871107|NCT00416572|BG001|Baseline|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
10871108|NCT00416572|BG002|Baseline|Control Condition|Participants received care as usual.
10871109|NCT00416572|BG003|Baseline|Total|Total of all reporting groups
10871110|NCT00416572|FG000|Participant Flow|Education Intervention|"Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.~Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read."
10871111|NCT00416572|FG001|Participant Flow|Nutrition Education Intervention|"Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.~The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it."
10871112|NCT00416572|FG002|Participant Flow|Control Condition|Participants received care as usual.
10871113|NCT00416572|OG000|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.
10871114|NCT00416572|OG001|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
10871115|NCT00416572|OG002|Outcome|Control Condition|Participants received care as usual
10871116|NCT00416572|EG000|Reported Event|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.
10871117|NCT00416572|EG001|Reported Event|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
10871118|NCT00416572|EG002|Reported Event|Control Condition|Participants received care as usual.
10871119|NCT00416598|BG000|Baseline|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
10871120|NCT00416598|FG000|Participant Flow|Treatment (Chemotherapy, PBSC or Bone Marrow Transplantation)|"See Detailed Description:~Patients undergo induction therapy comprising cytarabine and daunorubicin hydrochloride. Patient with RD undergo second induction therapy comprising cytarabine, daunorubicin hydrochloride, and etoposide. Patients with CR and favorable cytogenetics who achieve CR receive intensification therapy comprising high-dose cytarabine. Patients with UC receive etoposide, high-dose cytarabine, G-CSF., and busulfan and proceed to PBSC or bone marrow transplantation. Patients with UC and unable to undergo transplantation receive etoposide, high-dose cytarabine, and G-CSF. Patients then receive decitabine as maintenance therapy."
10871121|NCT00416598|OG000|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
10871122|NCT00416598|EG000|Reported Event|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
10871123|NCT00416624|BG000|Baseline|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
10871124|NCT00416624|BG001|Baseline|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
10871125|NCT00416624|BG002|Baseline|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
10871126|NCT00416624|BG003|Baseline|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
10871127|NCT00416624|BG004|Baseline|Total|Total of all reporting groups
10871128|NCT00416624|FG000|Participant Flow|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
10871129|NCT00416624|FG001|Participant Flow|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
10871130|NCT00416624|FG002|Participant Flow|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
10871131|NCT00416624|FG003|Participant Flow|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
10871132|NCT00416624|OG000|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
10871133|NCT00416624|OG001|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
10871134|NCT00416624|OG002|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
10871135|NCT00416624|OG003|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
10871136|NCT00416624|EG000|Reported Event|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
10871137|NCT00416624|EG001|Reported Event|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
10871138|NCT00416624|EG002|Reported Event|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
10871139|NCT00416624|EG003|Reported Event|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
10871140|NCT00416715|BG000|Baseline|Treatment (Letrozole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.~letrozole: Given PO~calcium carbonate: Given PO~laboratory biomarker analysis: Optional correlative studies~calcium citrate: Given PO~calcium glucarate: Given PO~calcium gluconate: Given PO~cholecalciferol: Given PO~assessment of therapy complications: Ancillary studies~musculoskeletal complications management/prevention: Correlative studies"
10871141|NCT00416715|FG000|Participant Flow|Treatment (Letrozole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.~letrozole: Given PO~calcium carbonate: Given PO~laboratory biomarker analysis: Optional correlative studies~calcium citrate: Given PO~calcium glucarate: Given PO~calcium gluconate: Given PO~cholecalciferol: Given PO~assessment of therapy complications: Ancillary studies~musculoskeletal complications management/prevention: Correlative studies"
10871142|NCT00416715|OG000|Outcome|Baseline|All patients that are evaluable for joint aches and vitamin D levels.
10871143|NCT00416715|OG001|Outcome|Post Vitamin D Repletion (1 Month)|Patients with vitamin D deficiency who experience myalgias, arthralgias and/or joint stiffness.
10871144|NCT00416715|OG000|Outcome|Baseline|Those receiving Letrozole + vitamin D3
10871145|NCT00416715|OG001|Outcome|Post Vitamin D Repletion (1 Month)|Those receiving Letrezole + vitamin D3
10879272|NCT00456547|FG001|Participant Flow|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
10871146|NCT00416715|EG000|Reported Event|Treatment (Letrezole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.~letrozole: Given PO~calcium carbonate: Given PO~laboratory biomarker analysis: Optional correlative studies~calcium citrate: Given PO~calcium glucarate: Given PO~calcium gluconate: Given PO~cholecalciferol: Given PO~assessment of therapy complications: Ancillary studies~musculoskeletal complications management/prevention: Correlative studies"
10871147|NCT00416793|BG000|Baseline|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
10871148|NCT00416793|FG000|Participant Flow|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
10871149|NCT00416793|OG000|Outcome|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
10871150|NCT00416793|EG000|Reported Event|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
10871151|NCT00416884|BG000|Baseline|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
10871152|NCT00416884|FG000|Participant Flow|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
10871153|NCT00416884|OG000|Outcome|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
10871154|NCT00416884|EG000|Reported Event|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
10871155|NCT00416949|BG000|Baseline|Patient-specific 3D-RD Dosimetry|Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
10871156|NCT00416949|FG000|Participant Flow|Patient-specific 3D-RD Dosimetry|Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
10871157|NCT00416949|OG000|Outcome|Patient-specific 3D-RD Dosimetry|Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
10871158|NCT00416949|EG000|Reported Event|Patient-specific 3D-RD Dosimetry|Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
10871159|NCT00417027|BG000|Baseline|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
10871160|NCT00417027|BG001|Baseline|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10871161|NCT00417027|BG002|Baseline|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10871162|NCT00417027|BG003|Baseline|Total|Total of all reporting groups
10871163|NCT00417027|FG000|Participant Flow|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
10871164|NCT00417027|FG001|Participant Flow|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10871165|NCT00417027|FG002|Participant Flow|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10871166|NCT00417027|OG000|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
10871167|NCT00417027|OG001|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10871168|NCT00417027|OG002|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10871169|NCT00417027|EG000|Reported Event|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
10879273|NCT00456547|OG000|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
10871170|NCT00417027|EG001|Reported Event|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10871171|NCT00417027|EG002|Reported Event|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10871172|NCT00417079|BG000|Baseline|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
10871173|NCT00417079|BG001|Baseline|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
10871174|NCT00417079|BG002|Baseline|Total|Total of all reporting groups
10871175|NCT00417079|FG000|Participant Flow|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
10871176|NCT00417079|FG001|Participant Flow|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
10871177|NCT00417079|OG000|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
10871178|NCT00417079|OG001|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
10871179|NCT00417079|EG000|Reported Event|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
10871180|NCT00417079|EG001|Reported Event|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
10871181|NCT00417170|BG000|Baseline|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
10871182|NCT00417170|BG001|Baseline|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
10871183|NCT00417170|BG002|Baseline|Total|Total of all reporting groups
10871184|NCT00417170|FG000|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
10871185|NCT00417170|FG001|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
10871186|NCT00417170|OG000|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
10871187|NCT00417170|OG001|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
10871188|NCT00417170|EG000|Reported Event|Aliskiren 300mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
10871189|NCT00417170|EG001|Reported Event|Amlodipine 5mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
10871190|NCT00417274|BG000|Baseline|Quinacrine Treatment|Uncontrolled treatment arm
10871191|NCT00417274|FG000|Participant Flow|Quinacrine Treatment|100 mg once a day
10871192|NCT00417274|OG000|Outcome|Quinacrine Treatment|100 mg once a day
10871193|NCT00417274|EG000|Reported Event|Quinacrine Treatment|Uncontrolled treatment arm
10871194|NCT00417417|BG000|Baseline|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
10871195|NCT00417417|BG001|Baseline|Placebo|placebo injected every two weeks for two months
10871196|NCT00417417|BG002|Baseline|Total|Total of all reporting groups
10871197|NCT00417417|FG000|Participant Flow|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
10871198|NCT00417417|FG001|Participant Flow|Placebo|placebo injected every two weeks x 4 administrations
10871199|NCT00417417|OG000|Outcome|Rilonacept|rilonacept 320 mg x 4 administrations over 8 weeks.
10871200|NCT00417417|OG001|Outcome|Placebo|Placebo x 4 injections over 8 weeks
10871201|NCT00417417|OG000|Outcome|Rilonacept|Rilonacept 320 mg subcutaneously x4 over 8 weeks
10871202|NCT00417417|OG001|Outcome|Placebo|Placebo subcutaneous injection x 4 over 8 weeks
10871203|NCT00417417|EG000|Reported Event|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
10871204|NCT00417417|EG001|Reported Event|Placebo|placebo injected every two weeks for two months
10871205|NCT00417482|BG000|Baseline|Phase B Arm 1: Risperidone-Risperidone|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
10871206|NCT00417482|BG001|Baseline|Phase B Arm 2: Risperidone -Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
10871207|NCT00417482|BG002|Baseline|Phase B Arm 3: Placebo-Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
10871208|NCT00417482|BG003|Baseline|Total|Total of all reporting groups
10871209|NCT00417482|FG000|Participant Flow|Arm 1: Risperidone-Risperidone|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 1: Risperidone for 16 weeks followed by risperidone for 16 weeks; Risperidone open label flexible dose was administered at a dose of 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for the randomized trial"
10871210|NCT00417482|FG001|Participant Flow|Phase B Arm 2: Risperidone-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 2: Risperidone for 16 weeks followed by placebo for 16 weeks;"
10871211|NCT00417482|FG002|Participant Flow|Phase B Arm 3: Placebo-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 3: Patients were randomized to placebo for 32 weeks."
10871212|NCT00417482|OG000|Outcome|Phase B Arm 1: Risperidone-Risperidone|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks.
10871213|NCT00417482|OG001|Outcome|Phase B Arm 2: Risperidone -Placebo|"38 patients randomized to Phase B Arm 2 received risperidone therapy for 16 weeks followed by placebo for 16 weeks.~In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
10871214|NCT00417482|OG002|Outcome|Phase B Arm 3: Placebo-Placebo|"40 patients randomized to Phase B Arm 3 received placebo for 32 weeks. For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.~In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
10871215|NCT00417482|OG000|Outcome|Arm 1: Risperidone - Risperidone|Subjects in Arm 1 who did not relapse or terminate from the study in the first 16 weeks of Phase B continued to receive risperidone in the second 16 weeks of Phase B.
10871216|NCT00417482|OG001|Outcome|Arm 2: Risperidone - Placebo|Subjects in Arm 2 who did not relapse or terminate from the study in the first 16 weeks of Phase B received placebo in the second 16 weeks of Phase B.
10871217|NCT00417482|OG000|Outcome|Placebo|Subjects assigned to Arm 3, as described above
10871218|NCT00417482|OG001|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
10871219|NCT00417482|EG000|Reported Event|Wk0-16 Phase B Arm 1 (Risp-Risp) & Arm 2 (Risp-Pla)|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks; 38 patients randomized to Phase B Arm 2 received risperidone for 16 weeks followed by placebo for 16 weeks. Therefore there were a total of 70 patients in this group.
10871220|NCT00417482|EG001|Reported Event|Wk 0-16 Phase B Arm 3: Placebo -Placebo|40 patients randomized to Phase B Arm 3 received placebo for 32 weeks.
10871221|NCT00417482|EG002|Reported Event|Wk 17-32 Phase B Arm 1: Risperdone-Risperdone|13 patients completed Wk 0-16 of Phase 2 Arm 1 and entered Wk 17-32 where they received risperidone for another 16 weeks.
10871222|NCT00417482|EG003|Reported Event|Wk 17-32 Phase B Arm 2: Risperdone-Placebo|27 patients completed Wk 0-16 of Phase B Arm 2 and entered Week 17-32 of Phase B Arm 2 where they receive placebo for 16 weeks.
10871223|NCT00417482|EG004|Reported Event|Wek 17-32 Phase B Arm 3: Placebo -Placebo|13 patients completed Week 0-16 of Phase B Arm 3 and entered Week 17-32 were they were given placebo for another 16 weeks.
10871224|NCT00417612|BG000|Baseline|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
10871225|NCT00417612|BG001|Baseline|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
10871226|NCT00417612|BG002|Baseline|Total|Total of all reporting groups
10871227|NCT00417612|FG000|Participant Flow|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce Parathyroid Hormone (PTH) level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
10871228|NCT00417612|FG001|Participant Flow|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
10871229|NCT00417612|OG000|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
10871230|NCT00417612|OG001|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
10871231|NCT00417612|OG002|Outcome|Paricalcitol (Children Ages 9-17)|Pediatric patients ages 9-17 given paricalcitol
10871232|NCT00417612|OG000|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce parathyroid hormone (PTH) level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
10871233|NCT00417612|EG000|Reported Event|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
10871234|NCT00417612|EG001|Reported Event|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
10871235|NCT00417859|BG000|Baseline|TKA Mobile|"TKA mobile~Total knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing"
10871236|NCT00417859|BG001|Baseline|TKA Fix|TKA fix
10871237|NCT00417859|BG002|Baseline|Total|Total of all reporting groups
10871238|NCT00417859|FG000|Participant Flow|TKA Mobile|"TKA mobile~Total knee arthroplasty with mobile bearing implant."
10871239|NCT00417859|FG001|Participant Flow|TKA Fix|Total knee arthroplasty with fixed bearing implant.
10871240|NCT00417859|OG000|Outcome|Preoperative|preoperative stride lenght of all participants
10871241|NCT00417859|OG001|Outcome|5 Years|stride lenght at 1 year following TKA of all participants
10871242|NCT00417859|OG000|Outcome|TKA Mobile|"TKA mobile~Total knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing"
10871243|NCT00417859|OG001|Outcome|TKA Fix|TKA fix
10871244|NCT00417859|EG000|Reported Event|TKA Mobile|"TKA mobile~Total knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing"
10871245|NCT00417859|EG001|Reported Event|TKA Fix|TKA fix
10871246|NCT00417885|BG000|Baseline|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
10871247|NCT00417885|FG000|Participant Flow|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
10871248|NCT00417885|OG000|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
10871249|NCT00417885|EG000|Reported Event|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
10871250|NCT00417963|BG000|Baseline|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
10871251|NCT00417963|FG000|Participant Flow|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
10871252|NCT00417963|OG000|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
10871253|NCT00417963|OG000|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
10871254|NCT00417963|OG001|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
10871255|NCT00417963|OG002|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
10871256|NCT00417963|OG000|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
10871257|NCT00417963|OG001|Outcome|6 Month Restenosis|Number of participants with restenosis at 6 months from implantation.
10871258|NCT00417963|EG000|Reported Event|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
10871259|NCT00417976|BG000|Baseline|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
10871260|NCT00417976|FG000|Participant Flow|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
10871261|NCT00417976|OG000|Outcome|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
10871262|NCT00417976|OG000|Outcome|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab: 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
10871263|NCT00417976|EG000|Reported Event|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab: 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
10871264|NCT00417989|BG000|Baseline|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
10871265|NCT00417989|BG001|Baseline|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
10871266|NCT00417989|BG002|Baseline|Total|Total of all reporting groups
10871267|NCT00417989|FG000|Participant Flow|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
10871268|NCT00417989|FG001|Participant Flow|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
10871269|NCT00417989|OG000|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
10871270|NCT00417989|OG001|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
10871271|NCT00417989|OG000|Outcome|722 Sensor Augmented Pump|"722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year~MiniMed Paradigm REAL-Time System: Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter"
10871272|NCT00417989|OG001|Outcome|Multiple Daily Injections (MDI)|MDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year
10871273|NCT00417989|EG000|Reported Event|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
10871274|NCT00417989|EG001|Reported Event|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
10871275|NCT00418015|BG000|Baseline|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
10871276|NCT00418015|BG001|Baseline|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
10871277|NCT00418015|BG002|Baseline|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
10871278|NCT00418015|BG003|Baseline|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
10871279|NCT00418015|BG004|Baseline|Total|Total of all reporting groups
10871280|NCT00418015|FG000|Participant Flow|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
10871281|NCT00418015|FG001|Participant Flow|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
10871282|NCT00418015|FG002|Participant Flow|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
10871283|NCT00418015|FG003|Participant Flow|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
10871284|NCT00418015|OG000|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
10871285|NCT00418015|OG001|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
10871286|NCT00418015|OG002|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
10871287|NCT00418015|OG003|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
10871288|NCT00418015|EG000|Reported Event|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
10871289|NCT00418015|EG001|Reported Event|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
10871290|NCT00418015|EG002|Reported Event|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
10871291|NCT00418015|EG003|Reported Event|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
10871292|NCT00418028|BG000|Baseline|Arm A (Cint)|"Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
10871293|NCT00418028|BG001|Baseline|Arm B (Ccont)|"Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
10871294|NCT00418028|BG002|Baseline|Total|Total of all reporting groups
10871295|NCT00418028|FG000|Participant Flow|Arm A (Cint)|"Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
10871296|NCT00418028|FG001|Participant Flow|Arm B (Ccont)|"Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
10871297|NCT00418028|OG000|Outcome|Arm A (Cint)|Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
10871298|NCT00418028|OG001|Outcome|Arm B (Ccont)|Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
10871299|NCT00418028|EG000|Reported Event|A Cint|"Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
10871300|NCT00418028|EG001|Reported Event|B Ccont|"Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
10871301|NCT00418093|BG000|Baseline|Group 1|
10871302|NCT00418093|FG000|Participant Flow|Chemotherapy Group|Oxaliplatin plus Gemcitabine plus Bevacizumab
10871303|NCT00418093|OG000|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
10871304|NCT00418093|EG000|Reported Event|Group 1|
10871305|NCT00418184|BG000|Baseline|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
10871306|NCT00418184|BG001|Baseline|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
10871307|NCT00418184|BG002|Baseline|Total|Total of all reporting groups
10871308|NCT00418184|FG000|Participant Flow|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
10871309|NCT00418184|FG001|Participant Flow|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
10871310|NCT00418184|OG000|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
10871311|NCT00418184|OG001|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
10871312|NCT00418184|EG000|Reported Event|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
10871313|NCT00418184|EG001|Reported Event|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
10871314|NCT00418262|BG000|Baseline|Atomoxetine HCL (Strattera)|"The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This titration will occur at each visit."
10871315|NCT00418262|FG000|Participant Flow|Atomoxetine HCL (Strattera)|The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This titration will occur at each visit.
10871316|NCT00418262|OG000|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
11223186|NCT02351700|FG001|Participant Flow|Standard Treatment Group|"IV Caldolor placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.~IV Ibuprofen placebo: Compare addition of IV ibuprofen placebo intraoperatively and postoperatively against IV Caldolor (IV ibuprofen) added intraoperatively and postoperatively."
10871317|NCT00418262|OG000|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
10871318|NCT00418262|OG000|Outcome|Atomoxetine HCL (Strattera)|"Visit 1~One additional subject left the study"
10871319|NCT00418262|OG000|Outcome|Atomoxetine HCL (Strattera)|One additional subject left the study
10871320|NCT00418262|OG000|Outcome|Atomoxetine HCL (Strattera)|"Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)~atomoxetine hydrochloride: Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food."
10871321|NCT00418262|EG000|Reported Event|Atomoxetine HCL (Strattera)|The subjects received 7 days of atomoxetine at 0.5 mg/kg/day. The children were seen weekly for assessment for 4 weeks then every two weeks until the eight week double blind period was completed. After each week of treatment, response was reassessed and the dose was increased to 1.0 then 1.4 mg/kg/d unless there were excessive side effects. The subjects were then invited to continue for 1 year to assess safety and efficacy
10871322|NCT00418314|BG000|Baseline|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
10871323|NCT00418314|BG001|Baseline|Control|Empiric programming or one-time optimization using a non-IEGM method.
10871324|NCT00418314|BG002|Baseline|Total|Total of all reporting groups
10871325|NCT00418314|FG000|Participant Flow|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
10871326|NCT00418314|FG001|Participant Flow|Control|Empiric programming or one-time optimization using a non-IEGM method.
10871327|NCT00418314|OG000|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
10871328|NCT00418314|OG001|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
10871329|NCT00418314|EG000|Reported Event|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
10871330|NCT00418314|EG001|Reported Event|Control|Empiric programming or one-time optimization using a non-IEGM method.
10871331|NCT00418379|BG000|Baseline|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
10871332|NCT00418379|BG001|Baseline|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
10871333|NCT00418379|BG002|Baseline|Placebo|Placebo tablet
10871334|NCT00418379|BG003|Baseline|Total|Total of all reporting groups
10871335|NCT00418379|FG000|Participant Flow|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
10871336|NCT00418379|FG001|Participant Flow|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
10871337|NCT00418379|FG002|Participant Flow|Placebo|Placebo tablet
10871338|NCT00418379|OG000|Outcome|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
10871339|NCT00418379|OG001|Outcome|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
10871340|NCT00418379|OG002|Outcome|Placebo|Placebo tablet
10871341|NCT00418379|EG000|Reported Event|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
10871342|NCT00418379|EG001|Reported Event|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
10871343|NCT00418379|EG002|Reported Event|Placebo|Placebo tablet
10871344|NCT00418457|BG000|Baseline|General Anesthesia and Opioid|"General anesthesia followed by opioid administration~General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia"
10871345|NCT00418457|BG001|Baseline|Regional Analgesia and Propofol|"Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol~Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia"
10871346|NCT00418457|BG002|Baseline|Total|Total of all reporting groups
10871347|NCT00418457|FG000|Participant Flow|General Anesthesia and Opioid|"General anesthesia followed by opioid administration~General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia"
10871348|NCT00418457|FG001|Participant Flow|Regional Analgesia and Propofol|"Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol~Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia"
10871349|NCT00418457|OG000|Outcome|General Anesthesia and Opioid|"General anesthesia followed by opioid administration~General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia"
10871350|NCT00418457|OG001|Outcome|Regional Analgesia and Propofol|"Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol~Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia"
10871351|NCT00418457|EG000|Reported Event|General Anesthesia and Opioid|"General anesthesia followed by opioid administration~General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia"
10871352|NCT00418457|EG001|Reported Event|Regional Analgesia and Propofol|"Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol~Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia"
10871353|NCT00418522|BG000|Baseline|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
10871354|NCT00418522|BG001|Baseline|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
10871355|NCT00418522|BG002|Baseline|Total|Total of all reporting groups
10871356|NCT00418522|FG000|Participant Flow|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
10871357|NCT00418522|FG001|Participant Flow|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
10871358|NCT00418522|OG000|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
10871359|NCT00418522|OG001|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
10871360|NCT00418522|EG000|Reported Event|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
10871361|NCT00418522|EG001|Reported Event|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
10871362|NCT00418561|BG000|Baseline|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871363|NCT00418561|BG001|Baseline|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871364|NCT00418561|BG002|Baseline|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871365|NCT00418561|BG003|Baseline|Total|Total of all reporting groups
10871366|NCT00418561|FG000|Participant Flow|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871367|NCT00418561|FG001|Participant Flow|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871368|NCT00418561|FG002|Participant Flow|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871369|NCT00418561|OG000|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871370|NCT00418561|OG001|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871371|NCT00418561|OG002|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871372|NCT00418561|EG000|Reported Event|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871373|NCT00418561|EG001|Reported Event|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871374|NCT00418561|EG002|Reported Event|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
10871375|NCT00418574|BG000|Baseline|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
10871376|NCT00418574|BG001|Baseline|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
10871377|NCT00418574|BG002|Baseline|Total|Total of all reporting groups
10871378|NCT00418574|FG000|Participant Flow|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
10871379|NCT00418574|FG001|Participant Flow|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
10871380|NCT00418574|OG000|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
10871381|NCT00418574|OG001|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
10871382|NCT00418574|EG000|Reported Event|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
10871383|NCT00418574|EG001|Reported Event|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
10871384|NCT00418665|BG000|Baseline|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871385|NCT00418665|BG001|Baseline|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871386|NCT00418665|BG002|Baseline|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871387|NCT00418665|BG003|Baseline|Total|Total of all reporting groups
10871388|NCT00418665|FG000|Participant Flow|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871389|NCT00418665|FG001|Participant Flow|Romiplostim (AMG 531) 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871390|NCT00418665|FG002|Participant Flow|Romiplostim (AMG 531) 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871391|NCT00418665|OG000|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871392|NCT00418665|OG001|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871393|NCT00418665|OG002|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
10871394|NCT00418665|EG000|Reported Event|Placebo|
10871395|NCT00418665|EG001|Reported Event|Romiplostim 500 µg|
10871396|NCT00418665|EG002|Reported Event|Romiplostim 750 µg|
10871397|NCT00418691|BG000|Baseline|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
10871398|NCT00418691|BG001|Baseline|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
10871399|NCT00418691|BG002|Baseline|Modafinil|18 mg PO once daily for 4 weeks
10871400|NCT00418691|BG003|Baseline|Total|Total of all reporting groups
10871401|NCT00418691|FG000|Participant Flow|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
10871402|NCT00418691|FG001|Participant Flow|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
10871403|NCT00418691|FG002|Participant Flow|Modafinil|18 mg PO once daily for 4 weeks
10871404|NCT00418691|OG000|Outcome|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
10871405|NCT00418691|OG001|Outcome|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
10871406|NCT00418691|OG002|Outcome|Modafinil|18 mg PO once daily for 4 weeks
10871407|NCT00418691|EG000|Reported Event|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
10871408|NCT00418691|EG001|Reported Event|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
10871409|NCT00418691|EG002|Reported Event|Modafinil|18 mg PO once daily for 4 weeks
10871410|NCT00418717|BG000|Baseline|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
10871411|NCT00418717|FG000|Participant Flow|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
10871412|NCT00418717|OG000|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
10871413|NCT00418717|EG000|Reported Event|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
10871414|NCT00418886|BG000|Baseline|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
10871415|NCT00418886|BG001|Baseline|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
10871416|NCT00418886|BG002|Baseline|Total|Total of all reporting groups
10871417|NCT00418886|FG000|Participant Flow|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
10871418|NCT00418886|FG001|Participant Flow|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
10871419|NCT00418886|OG000|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
10871420|NCT00418886|OG001|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
10871421|NCT00418886|EG000|Reported Event|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
10871422|NCT00418886|EG001|Reported Event|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
10871423|NCT00418938|BG000|Baseline|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
10871424|NCT00418938|BG001|Baseline|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
10871425|NCT00418938|BG002|Baseline|Total|Total of all reporting groups
10871426|NCT00418938|FG000|Participant Flow|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
10871427|NCT00418938|FG001|Participant Flow|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
10871428|NCT00418938|OG000|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
10871429|NCT00418938|OG001|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
10871430|NCT00418938|EG000|Reported Event|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
10871431|NCT00418938|EG001|Reported Event|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
10871432|NCT00418951|BG000|Baseline|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
10871433|NCT00418951|BG001|Baseline|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
10871434|NCT00418951|BG002|Baseline|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
10871435|NCT00418951|BG003|Baseline|Total|Total of all reporting groups
10871436|NCT00418951|FG000|Participant Flow|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
10871437|NCT00418951|FG001|Participant Flow|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
10871438|NCT00418951|FG002|Participant Flow|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
10871439|NCT00418951|OG000|Outcome|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
10871440|NCT00418951|OG001|Outcome|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
10871441|NCT00418951|OG002|Outcome|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
10871442|NCT00418951|EG000|Reported Event|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
10871443|NCT00418951|EG001|Reported Event|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
10871444|NCT00418951|EG002|Reported Event|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
10871445|NCT00418964|BG000|Baseline|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
10871446|NCT00418964|BG001|Baseline|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
10871447|NCT00418964|BG002|Baseline|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
10871448|NCT00418964|BG003|Baseline|Total|Total of all reporting groups
10871449|NCT00418964|FG000|Participant Flow|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
10871450|NCT00418964|FG001|Participant Flow|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
10871451|NCT00418964|FG002|Participant Flow|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
10871452|NCT00418964|OG000|Outcome|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
10871453|NCT00418964|OG001|Outcome|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
10871454|NCT00418964|OG002|Outcome|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
10871455|NCT00418964|EG000|Reported Event|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
10871456|NCT00418964|EG001|Reported Event|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
10871457|NCT00418964|EG002|Reported Event|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
10871458|NCT00418977|BG000|Baseline|Family Based Therapy|Participants received family based therapy (FBT)
10871459|NCT00418977|BG001|Baseline|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
10871460|NCT00418977|BG002|Baseline|Total|Total of all reporting groups
10879274|NCT00456547|OG001|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
10871461|NCT00418977|FG000|Participant Flow|Family Based Therapy|"Participants received family based therapy (FBT)~Family-Based Therapy (Maudsley Method): The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction."
10871462|NCT00418977|FG001|Participant Flow|Individual Supportive Psychotherapy|"Participants received individual supportive psychotherapy (ISP)~Individual Supportive Psychotherapy: The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment."
10871463|NCT00418977|OG000|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
10871464|NCT00418977|OG001|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
10871465|NCT00418977|EG000|Reported Event|Family Based Therapy|Participants received family based therapy (FBT)
10871466|NCT00418977|EG001|Reported Event|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
10871467|NCT00419003|BG000|Baseline|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
10871468|NCT00419003|BG001|Baseline|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
10871469|NCT00419003|BG002|Baseline|Total|Total of all reporting groups
10871470|NCT00419003|FG000|Participant Flow|Lamotrigine Pre-Treatment (Phase I)/Riluzole (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
10871471|NCT00419003|FG001|Participant Flow|Placebo Pre-Treatment (Phase I)/Placebo (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
10871472|NCT00419003|OG000|Outcome|Riluzole Group|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo. One patient in the riluzole group was discontinued/withdrew consent before completing the study.
10871473|NCT00419003|OG001|Outcome|Placebo|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo.
10871474|NCT00419003|EG000|Reported Event|Riluzole Group|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
10871475|NCT00419003|EG001|Reported Event|Placebo|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
10871476|NCT00419003|EG002|Reported Event|Ketamine|IV infusion of 0.5 mg/kg of Ketamine Hydrochloride
10871477|NCT00419003|EG003|Reported Event|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
10871478|NCT00419003|EG004|Reported Event|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
10871479|NCT00419094|BG000|Baseline|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
10871480|NCT00419094|BG001|Baseline|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
10871481|NCT00419094|BG002|Baseline|Total|Total of all reporting groups
10871482|NCT00419094|FG000|Participant Flow|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
10871483|NCT00419094|FG001|Participant Flow|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
10871484|NCT00419094|OG000|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
10871485|NCT00419094|OG001|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
10871486|NCT00419094|EG000|Reported Event|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
10871487|NCT00419094|EG001|Reported Event|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
10871488|NCT00419120|BG000|Baseline|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
10871489|NCT00419120|FG000|Participant Flow|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
10871490|NCT00419120|OG000|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
10871491|NCT00419120|EG000|Reported Event|Safety Population|All patients undergoing screeing and meeting inclusion/exclusion criteria
10871492|NCT00419159|BG000|Baseline|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871493|NCT00419159|BG001|Baseline|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871494|NCT00419159|BG002|Baseline|Total|Total of all reporting groups
10871495|NCT00419159|FG000|Participant Flow|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871496|NCT00419159|FG001|Participant Flow|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871497|NCT00419159|OG000|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871498|NCT00419159|OG001|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871499|NCT00419159|OG000|Outcome|KRAS Mutation/Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871500|NCT00419159|OG001|Outcome|KRAS Wildtype/Everolimus (RAD001) 70 mg/Week|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs
10871501|NCT00419159|OG000|Outcome|KRAS Mutation/Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs
10871502|NCT00419159|OG001|Outcome|KRAS Wildtype/Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs
10871503|NCT00419159|OG000|Outcome|PTEN Expression Low/Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871504|NCT00419159|OG001|Outcome|PTEN Expression Normal/Everolimus (RAD001) 70 mg/Week|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs
10871505|NCT00419159|OG000|Outcome|PTEN Expression Low/Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs
10871506|NCT00419159|OG001|Outcome|PTEN Expression Normal/Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs
10871507|NCT00419159|EG000|Reported Event|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871508|NCT00419159|EG001|Reported Event|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
10871509|NCT00419263|BG000|Baseline|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
10871510|NCT00419263|BG001|Baseline|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
10871511|NCT00419263|BG002|Baseline|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
10871512|NCT00419263|BG003|Baseline|Total|Total of all reporting groups
10871513|NCT00419263|FG000|Participant Flow|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
10871514|NCT00419263|FG001|Participant Flow|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
10871515|NCT00419263|FG002|Participant Flow|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
10871516|NCT00419263|OG000|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
10871517|NCT00419263|OG001|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
10871518|NCT00419263|OG002|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
10871519|NCT00419263|EG000|Reported Event|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
10871520|NCT00419263|EG001|Reported Event|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
10871521|NCT00419263|EG002|Reported Event|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
10871522|NCT00419263|EG003|Reported Event|Total|Total number of subjects who received at least 1 dose of study drug
10871523|NCT00419315|BG000|Baseline|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
10871524|NCT00419315|BG001|Baseline|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
10871525|NCT00419315|BG002|Baseline|Total|Total of all reporting groups
10871526|NCT00419315|FG000|Participant Flow|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
10871527|NCT00419315|FG001|Participant Flow|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
10871528|NCT00419315|OG000|Outcome|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
11098952|NCT01579045|OG004|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
10871529|NCT00419315|OG001|Outcome|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
11098953|NCT01579045|EG000|Reported Event|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
10871530|NCT00419315|EG000|Reported Event|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
10871531|NCT00419315|EG001|Reported Event|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
10871532|NCT00419341|BG000|Baseline|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
10871533|NCT00419341|FG000|Participant Flow|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
10871534|NCT00419341|OG000|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
10871535|NCT00419341|OG000|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
10871536|NCT00419341|OG001|Outcome|IVIG (Privigen; Previous Study)|Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
10871537|NCT00419341|EG000|Reported Event|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
10871538|NCT00419380|BG000|Baseline|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
10871539|NCT00419380|BG001|Baseline|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
10871540|NCT00419380|BG002|Baseline|Total|Total of all reporting groups
10871541|NCT00419380|FG000|Participant Flow|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
10871542|NCT00419380|FG001|Participant Flow|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
10871543|NCT00419380|OG000|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
10871544|NCT00419380|OG001|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
10871545|NCT00419380|EG000|Reported Event|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
10871546|NCT00419380|EG001|Reported Event|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
10871547|NCT00419393|BG000|Baseline|Keppra XR (Levetiracetam XR)|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
10871548|NCT00419393|FG000|Participant Flow|Keppra XR (Levetiracetam XR)|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
10879275|NCT00456547|EG000|Reported Event|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
10871549|NCT00419393|OG000|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
10871550|NCT00419393|EG000|Reported Event|Keppra XR (Levetiracetam XR)|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
10871551|NCT00419445|BG000|Baseline|25 mg Tid|
10871552|NCT00419445|BG001|Baseline|75 mg Tid|
10871553|NCT00419445|BG002|Baseline|150 mg Tid|
10871554|NCT00419445|BG003|Baseline|Total|Total of all reporting groups
10871555|NCT00419445|FG000|Participant Flow|25 mg Tid|
10871556|NCT00419445|FG001|Participant Flow|75 mg Tid|
10871557|NCT00419445|FG002|Participant Flow|150 mg Tid|
10871558|NCT00419445|OG000|Outcome|25 mg Tid|
10871559|NCT00419445|OG001|Outcome|75 mg Tid|
10871560|NCT00419445|OG002|Outcome|150 mg Tid|
10871561|NCT00419445|EG000|Reported Event|25 mg Tid|
10871562|NCT00419445|EG001|Reported Event|75 mg Tid|
10871563|NCT00419445|EG002|Reported Event|150 mg Tid|
10871564|NCT00419562|BG000|Baseline|Oral Insulin|7.5 mg oral insulin capsules given before breakfast on a daily basis.
10871565|NCT00419562|BG001|Baseline|Placebo|Placebo capsule designed to mimic appearance of treatment capsule
10871566|NCT00419562|BG002|Baseline|Total|Total of all reporting groups
10871567|NCT00419562|FG000|Participant Flow|7.5 mg Oral Insulin Capsules|given before breakfast on a daily basis.
10871568|NCT00419562|FG001|Participant Flow|Placebo Capsule|designed to mimic appearance of treatment capsule
10871569|NCT00419562|OG000|Outcome|Oral Insulin|7.5 mg oral insulin capsules given before breakfast on a daily basis.
10871570|NCT00419562|OG001|Outcome|Placebo|Placebo capsule designed to mimic appearance of treatment capsule
10871571|NCT00419562|EG000|Reported Event|Oral Insulin|7.5 mg oral insulin capsules given before breakfast on a daily basis.
10871572|NCT00419562|EG001|Reported Event|Placebo|Placebo capsule designed to mimic appearance of treatment capsule
10871573|NCT00419666|BG000|Baseline|Calcitriol 3mcg/g|Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
10871574|NCT00419666|FG000|Participant Flow|Calcitriol 3mcg/g|Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
10871575|NCT00419666|OG000|Outcome|Calcitriol 3mcg/g|Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
10871576|NCT00419666|EG000|Reported Event|Calcitriol 3mcg/g|Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
10871577|NCT00419744|BG000|Baseline|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
10871578|NCT00419744|BG001|Baseline|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
10871579|NCT00419744|BG002|Baseline|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
10871580|NCT00419744|BG003|Baseline|Total|Total of all reporting groups
10871581|NCT00419744|FG000|Participant Flow|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
10871582|NCT00419744|FG001|Participant Flow|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
10871583|NCT00419744|FG002|Participant Flow|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
10871584|NCT00419744|OG000|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
10871585|NCT00419744|OG001|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
10871586|NCT00419744|OG002|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
10871587|NCT00419744|EG000|Reported Event|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
10871588|NCT00419744|EG001|Reported Event|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
10871589|NCT00419744|EG002|Reported Event|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
10871590|NCT00419757|BG000|Baseline|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
10871591|NCT00419757|BG001|Baseline|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
10871592|NCT00419757|BG002|Baseline|Total|Total of all reporting groups
10871593|NCT00419757|FG000|Participant Flow|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
10871594|NCT00419757|FG001|Participant Flow|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
10871595|NCT00419757|OG000|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
10871596|NCT00419757|OG001|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
10871597|NCT00419757|OG000|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
10871598|NCT00419757|OG001|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
10871599|NCT00419757|EG000|Reported Event|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
10871600|NCT00419757|EG001|Reported Event|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
10871601|NCT00419770|BG000|Baseline|Deferasirox|Deferasirox plus liposomal amphotericin
10871602|NCT00419770|BG001|Baseline|Placebo|Placebo control plus background liposomal amphotericin
10871603|NCT00419770|BG002|Baseline|Total|Total of all reporting groups
10871604|NCT00419770|FG000|Participant Flow|Deferasirox|Deferasirox plus liposomal amphotericin
10871605|NCT00419770|FG001|Participant Flow|Placebo|Placebo control plus background liposomal amphotericin
10871606|NCT00419770|OG000|Outcome|Deferasirox|Deferasirox plus liposomal amphotericin
10871607|NCT00419770|OG001|Outcome|Placebo|Placebo control plus background liposomal amphotericin
10871608|NCT00419770|EG000|Reported Event|Deferasirox|Deferasirox plus liposomal amphotericin
10871609|NCT00419770|EG001|Reported Event|Placebo|Placebo control plus background liposomal amphotericin
10871610|NCT00419926|BG000|Baseline|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
10871611|NCT00419926|BG001|Baseline|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
10871612|NCT00419926|BG002|Baseline|Total|Total of all reporting groups
10871613|NCT00419926|FG000|Participant Flow|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
10871614|NCT00419926|FG001|Participant Flow|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
10871615|NCT00419926|OG000|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
10871616|NCT00419926|OG001|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
10871617|NCT00419926|EG000|Reported Event|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
10871618|NCT00419926|EG001|Reported Event|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
10871619|NCT00419952|BG000|Baseline|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
10871620|NCT00419952|BG001|Baseline|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
10871621|NCT00419952|BG002|Baseline|Total|Total of all reporting groups
10871622|NCT00419952|FG000|Participant Flow|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
10871623|NCT00419952|FG001|Participant Flow|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
10871624|NCT00419952|OG000|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
10871625|NCT00419952|OG001|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
10871626|NCT00419952|EG000|Reported Event|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
10871627|NCT00419952|EG001|Reported Event|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
10871628|NCT00420004|BG000|Baseline|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
10871629|NCT00420004|BG001|Baseline|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
10871630|NCT00420004|BG002|Baseline|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
10871631|NCT00420004|BG003|Baseline|Total|Total of all reporting groups
10871632|NCT00420004|FG000|Participant Flow|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
10871633|NCT00420004|FG001|Participant Flow|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
10871634|NCT00420004|FG002|Participant Flow|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
10871635|NCT00420004|OG000|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
10871636|NCT00420004|OG001|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
10871637|NCT00420004|OG002|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
10871638|NCT00420004|OG000|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks.
10871639|NCT00420004|EG000|Reported Event|LY2216684 Double Blind Phase|LY2216684: 3, 6, 9, or 12 milligrams (mg) tablets, administered orally with flexible dosing, once daily for 8 weeks
10871640|NCT00420004|EG001|Reported Event|Placebo Double Blind Phase|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally once daily for 8 weeks
10871641|NCT00420004|EG002|Reported Event|Escitalopram Double Blind Phase|Escitalopram: 10 or 20 mg capsules, administered orally with flexible dosing, once daily for 8 weeks
10871642|NCT00420004|EG003|Reported Event|LY2216684 Discontinuation Phase|Included all randomized participants who discontinued LY2216684 treatment
10871643|NCT00420004|EG004|Reported Event|Placebo Discontinuation Phase|Included all randomized participants who discontinued placebo
10871644|NCT00420004|EG005|Reported Event|Escitalopram Discontinuation Phase|Included all randomized participants who discontinued escitalopram treatment
10871645|NCT00420017|BG000|Baseline|Amiodarone|Intravenous amiodarone
10871646|NCT00420017|BG001|Baseline|Control|Control usual care
10871647|NCT00420017|BG002|Baseline|Total|Total of all reporting groups
10871648|NCT00420017|FG000|Participant Flow|Amiodarone|Intravenous amiodarone
10871649|NCT00420017|FG001|Participant Flow|Control|Control usual care
10871650|NCT00420017|OG000|Outcome|Amiodarone|Intravenous amiodarone
10871651|NCT00420017|OG001|Outcome|Control|Control usual care
10871652|NCT00420017|EG000|Reported Event|Amiodarone|Intravenous amiodarone
10871653|NCT00420017|EG001|Reported Event|Control|Control usual care
10871654|NCT00420056|BG000|Baseline|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
10871655|NCT00420056|FG000|Participant Flow|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
10871656|NCT00420056|OG000|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
10871657|NCT00420056|EG000|Reported Event|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
10871658|NCT00420095|BG000|Baseline|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
10871659|NCT00420095|BG001|Baseline|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
10871660|NCT00420095|BG002|Baseline|Total|Total of all reporting groups
11336367|NCT03565315|OG003|Outcome|Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
10871661|NCT00420095|FG000|Participant Flow|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
10871662|NCT00420095|FG001|Participant Flow|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
10871663|NCT00420095|OG000|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
10871664|NCT00420095|OG001|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
10871665|NCT00420095|EG000|Reported Event|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
10871666|NCT00420095|EG001|Reported Event|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
10871667|NCT00420147|BG000|Baseline|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a neutral (non-wedged) in-shoe orthosis as their treatment.
10871668|NCT00420147|BG001|Baseline|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a wedged in-shoe orthosis as their treatment.
10871669|NCT00420147|BG002|Baseline|Total|Total of all reporting groups
10871670|NCT00420147|FG000|Participant Flow|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a neutral in shoe orthosis
10871671|NCT00420147|FG001|Participant Flow|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a laterally wedged in shoe orthosis
10871672|NCT00420147|OG000|Outcome|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis
10871673|NCT00420147|OG001|Outcome|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis
10871674|NCT00420147|EG000|Reported Event|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis. They were prescribed and wore a neutral in-shoe orthosis.
10871675|NCT00420147|EG001|Reported Event|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis. They were prescribed and wore a laterally wedged in-shoe orthosis.
10871676|NCT00420199|BG000|Baseline|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
10871677|NCT00420199|BG001|Baseline|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
10871678|NCT00420199|BG002|Baseline|Total|Total of all reporting groups
10871679|NCT00420199|FG000|Participant Flow|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered intravenously (IV) on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
11336368|NCT03565315|OG000|Outcome|All 10E8VLS 5 mg/kg SC Groups (With or Without VRC07-523LS)|Total number of participants who received 10E8VLS administered alone or concurrently with VRC07-523LS
10871680|NCT00420199|FG001|Participant Flow|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
10871681|NCT00420199|OG000|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
10871682|NCT00420199|OG001|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
10871683|NCT00420199|OG001|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
10871684|NCT00420199|OG000|Outcome|Abatacept + Methotrexate|Abatacept was administered IV and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
10871685|NCT00420199|OG000|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
10871686|NCT00420199|OG001|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
10871687|NCT00420199|OG001|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
10871688|NCT00420199|EG000|Reported Event|ABA + MTX|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
10871689|NCT00420199|EG001|Reported Event|PLA + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
10871690|NCT00420212|BG000|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
10871691|NCT00420212|BG001|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10871692|NCT00420212|BG002|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10871693|NCT00420212|BG003|Baseline|Total|Total of all reporting groups
10871694|NCT00420212|FG000|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
10871695|NCT00420212|FG001|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10871696|NCT00420212|FG002|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10871697|NCT00420212|OG000|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
10871698|NCT00420212|OG001|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10871699|NCT00420212|OG002|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10871700|NCT00420212|OG001|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10871701|NCT00420212|OG002|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10871702|NCT00420212|EG000|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
10871703|NCT00420212|EG001|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10871704|NCT00420212|EG002|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10871705|NCT00420212|EG003|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
10871706|NCT00420238|BG000|Baseline|Etanercept|50 mg subcutaneously (SC), once weekly
10871707|NCT00420238|BG001|Baseline|Placebo|Subcutaneously (SC), once weekly
10871708|NCT00420238|BG002|Baseline|Total|Total of all reporting groups
10871709|NCT00420238|FG000|Participant Flow|Etanercept/Etanercept|Etanercept 50 mg subcutaneously (SC) once weekly
10871710|NCT00420238|FG001|Participant Flow|Placebo/Etanercept|Placebo subcutaneously (SC), once weekly; Etanercept 50 mg SC, once weekly
10871711|NCT00420238|OG000|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
10871712|NCT00420238|OG001|Outcome|Placebo|Subcutaneously (SC), once weekly
10871713|NCT00420238|OG000|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: etanercept 50 mg subcutaneously (SC), once weekly
10871714|NCT00420238|OG001|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
10871715|NCT00420238|OG000|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
10871716|NCT00420238|OG001|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
10871717|NCT00420238|EG000|Reported Event|Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly
10871718|NCT00420238|EG001|Reported Event|Placebo|Double-blind Period 1: placebo subcutaneously (SC), once weekly
10871719|NCT00420238|EG002|Reported Event|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
10871720|NCT00420238|EG003|Reported Event|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
10871721|NCT00420290|BG000|Baseline|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
10871722|NCT00420290|BG001|Baseline|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
10871723|NCT00420290|BG002|Baseline|Total|Total of all reporting groups
10871724|NCT00420290|FG000|Participant Flow|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
10871725|NCT00420290|FG001|Participant Flow|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
10871726|NCT00420290|OG000|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
10871727|NCT00420290|OG001|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
10871728|NCT00420290|EG000|Reported Event|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
10871729|NCT00420290|EG001|Reported Event|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
10871730|NCT00420303|BG000|Baseline|Etanercept|50mg subcutaneously once weekly
10871731|NCT00420303|BG001|Baseline|Placebo|Subcutaneously once weekly
10871732|NCT00420303|BG002|Baseline|Total|Total of all reporting groups
10871733|NCT00420303|FG000|Participant Flow|Etanercept|50mg subcutaneously once weekly
10871734|NCT00420303|FG001|Participant Flow|Placebo|Subcutaneously once weekly
10871735|NCT00420303|OG000|Outcome|Etanercept|50mg subcutaneously once weekly
10871736|NCT00420303|OG001|Outcome|Placebo|Subcutaneously once weekly
10871737|NCT00420303|EG000|Reported Event|Etanercept|50mg subcutaneously once weekly
10871738|NCT00420303|EG001|Reported Event|Placebo|Subcutaneously once weekly
10871739|NCT00420316|BG000|Baseline|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
10871740|NCT00420316|BG001|Baseline|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
10871741|NCT00420316|BG002|Baseline|Total|Total of all reporting groups
10871742|NCT00420316|FG000|Participant Flow|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
10871743|NCT00420316|FG001|Participant Flow|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
10871744|NCT00420316|OG000|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
10871745|NCT00420316|OG001|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
10871746|NCT00420316|EG000|Reported Event|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
10871747|NCT00420316|EG001|Reported Event|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
10871748|NCT00420342|BG000|Baseline|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871749|NCT00420342|BG001|Baseline|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871750|NCT00420342|BG002|Baseline|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871751|NCT00420342|BG003|Baseline|Total|Total of all reporting groups
10871752|NCT00420342|FG000|Participant Flow|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871753|NCT00420342|FG001|Participant Flow|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871754|NCT00420342|FG002|Participant Flow|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871755|NCT00420342|OG000|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871756|NCT00420342|OG001|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871757|NCT00420342|OG002|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871758|NCT00420342|EG000|Reported Event|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871759|NCT00420342|EG001|Reported Event|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871760|NCT00420342|EG002|Reported Event|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
10871761|NCT00420381|BG000|Baseline|Enzastaurin|1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
10871762|NCT00420381|FG000|Participant Flow|Enzastaurin|1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
10871763|NCT00420381|OG000|Outcome|Enzastaurin|1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
10871764|NCT00420381|EG000|Reported Event|Enzastaurin|1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
10871765|NCT00420407|BG000|Baseline|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
10871766|NCT00420407|BG001|Baseline|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
10871767|NCT00420407|BG002|Baseline|Total|Total of all reporting groups
10871768|NCT00420407|FG000|Participant Flow|Normal Saline|"bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
10871769|NCT00420407|FG001|Participant Flow|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
10871770|NCT00420407|OG000|Outcome|Normal Saline|bolus of NS followed by continuous infusion of NS, no vasopressin added normal saline control : no vasopressin added to bolus or 5 hour continuous infusion
10871771|NCT00420407|OG001|Outcome|Vasopressin|vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
10871772|NCT00420407|OG000|Outcome|Evaluation of Vasopressin Level Following Trauma|All traumatic subjects that had a blood sample assessed for vasopressin.
10871773|NCT00420407|EG000|Reported Event|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
10871774|NCT00420407|EG001|Reported Event|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
10871775|NCT00420420|BG000|Baseline|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
10871776|NCT00420420|BG001|Baseline|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
10871777|NCT00420420|BG002|Baseline|Total|Total of all reporting groups
10871778|NCT00420420|FG000|Participant Flow|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
10871779|NCT00420420|FG001|Participant Flow|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
10871780|NCT00420420|OG000|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
10871781|NCT00420420|OG001|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
10871782|NCT00420420|EG000|Reported Event|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
10871783|NCT00420420|EG001|Reported Event|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
10871784|NCT00420459|BG000|Baseline|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
10871785|NCT00420459|FG000|Participant Flow|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.
10871786|NCT00420459|OG000|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole. Mean final dose was 9.8 mg/day
10871787|NCT00420459|OG000|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.
10871788|NCT00420459|OG000|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
10871789|NCT00420459|EG000|Reported Event|Aripiprazole|
10871790|NCT00420511|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
10871791|NCT00420511|BG001|Baseline|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
10871792|NCT00420511|BG002|Baseline|Total|Total of all reporting groups
10871793|NCT00420511|FG000|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
10871794|NCT00420511|FG001|Participant Flow|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
10871795|NCT00420511|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (orally administered)
10871796|NCT00420511|OG001|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (orally administered)
10871797|NCT00420511|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
10871798|NCT00420511|OG001|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
10871799|NCT00420511|EG000|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
10871800|NCT00420511|EG001|Reported Event|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
10871801|NCT00420628|BG000|Baseline|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
10871802|NCT00420628|BG001|Baseline|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
10871803|NCT00420628|BG002|Baseline|Total|Total of all reporting groups
10871804|NCT00420628|FG000|Participant Flow|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
10871805|NCT00420628|FG001|Participant Flow|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
10871806|NCT00420628|OG000|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
10871807|NCT00420628|OG001|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
10871808|NCT00420628|EG000|Reported Event|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
10871809|NCT00420628|EG001|Reported Event|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
10871810|NCT00420641|BG000|Baseline|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871811|NCT00420641|BG001|Baseline|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871812|NCT00420641|BG002|Baseline|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871813|NCT00420641|BG003|Baseline|Total|Total of all reporting groups
10871814|NCT00420641|FG000|Participant Flow|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in Montgomery-Asberg Depression Rating Scale [MADRS] total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871815|NCT00420641|FG001|Participant Flow|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10879276|NCT00456547|EG001|Reported Event|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
10879277|NCT00456599|BG000|Baseline|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
10977094|NCT00943670|BG000|Baseline|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
10977095|NCT00943670|FG000|Participant Flow|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
10977096|NCT00943670|OG000|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977097|NCT00943670|OG000|Outcome|Average QTc Interval ≤ 450 ms|Participants with an average QTc interval less than or equal to 450 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977098|NCT00943670|OG001|Outcome|Average QTc Interval > 450 to ≤ 480 ms|Participants with an average QTc interval greater than 450 and less than or equal to 480 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977099|NCT00943670|OG002|Outcome|Average QTc Interval > 480 to ≤ 500 ms|Participants with an average QTc interval greater than 480 and less than or equal to 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977100|NCT00943670|OG003|Outcome|Average QTc Interval > 500 ms|Participants with an average QTc interval greater than 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977101|NCT00943670|OG000|Outcome|Baseline-adjusted QTc Interval ≤ 30 ms|Participants with an average Baseline-adjusted QTc interval less than or equal to 30 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977102|NCT00943670|OG001|Outcome|Baseline-adjusted QTc Interval > 30 to ≤ 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 30 and less than or equal to 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977103|NCT00943670|OG002|Outcome|Baseline-adjusted QTc Interval > 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977104|NCT00943670|OG000|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
10977105|NCT00943670|OG001|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
10977106|NCT00943670|OG000|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977107|NCT00943670|EG000|Reported Event|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
10977108|NCT00943670|EG001|Reported Event|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
10977109|NCT00943735|BG000|Baseline|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
10977110|NCT00943735|FG000|Participant Flow|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
10977111|NCT00943735|OG000|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
10977112|NCT00943735|EG000|Reported Event|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
10977113|NCT00943761|BG000|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
10977114|NCT00943761|BG001|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
10977115|NCT00943761|BG002|Baseline|Total|Total of all reporting groups
10977116|NCT00943761|FG000|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination pegylated interferon (peg-IFN) 180 mcg weekly and ribavirin (RBV) 1000 or 1200 mg administered as a divided dose twice daily.
10977117|NCT00943761|FG001|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
10977118|NCT00943761|OG000|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
10977119|NCT00943761|OG001|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
10977120|NCT00943761|EG000|Reported Event|Vaniprevir 300 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
10977121|NCT00943761|EG001|Reported Event|Vaniprevir 600 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
10977122|NCT00943787|BG000|Baseline|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
10977123|NCT00943787|FG000|Participant Flow|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
10977124|NCT00943787|OG000|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
10977125|NCT00943787|EG000|Reported Event|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
10977126|NCT00943800|BG000|Baseline|Treatment Group|"Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m^2 of Fludarabine from Day-7 until Day-3, 140mg/m^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
10977127|NCT00943800|FG000|Participant Flow|Treatment Group|"Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients.~Subjects received 30mg/m^2 of Fludarabine from Day-7 until Day-3, 140mg/m^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
10977128|NCT00943800|OG000|Outcome|Treatment Group|"Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m^2 of Fludarabine from Day-7 until Day-3, 140mg/m^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
10977129|NCT00943800|EG000|Reported Event|Treatment Group|"Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m^2 of Fludarabine from Day-7 until Day-3, 140mg/m^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
10977130|NCT00943826|BG000|Baseline|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
10977131|NCT00943826|BG001|Baseline|Placebo + RT +Temozolomide|In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
10977132|NCT00943826|BG002|Baseline|Total|Total of all reporting groups
10977133|NCT00943826|FG000|Participant Flow|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
11007034|NCT01089127|BG005|Baseline|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007035|NCT01089127|BG006|Baseline|Total|Total of all reporting groups
10871816|NCT00420641|FG002|Participant Flow|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871817|NCT00420641|OG000|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871818|NCT00420641|OG001|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871819|NCT00420641|OG002|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871820|NCT00420641|EG000|Reported Event|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871821|NCT00420641|EG001|Reported Event|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871822|NCT00420641|EG002|Reported Event|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
10871823|NCT00420745|BG000|Baseline|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
10871824|NCT00420745|BG001|Baseline|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
10871825|NCT00420745|BG002|Baseline|Total|Total of all reporting groups
10871826|NCT00420745|FG000|Participant Flow|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
10871827|NCT00420745|FG001|Participant Flow|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
10871828|NCT00420745|OG000|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
10871829|NCT00420745|OG001|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
10871830|NCT00420745|EG000|Reported Event|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
10871831|NCT00420745|EG001|Reported Event|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
10871832|NCT00420771|BG000|Baseline|Gabapentin|gabapentin treatment 1200 mg three times daily
10871833|NCT00420771|BG001|Baseline|Placebo|Placebo condition received pills identical in appearance to experimental arm.
10871834|NCT00420771|BG002|Baseline|Total|Total of all reporting groups
10871835|NCT00420771|FG000|Participant Flow|Gabapentin|gabapentin treatment 1200 mg three times daily
10871836|NCT00420771|FG001|Participant Flow|Placebo|Placebo condition received pills identical in appearance to experimental arm.
10871837|NCT00420771|OG000|Outcome|Active Medication|"gabapentin treatment 1200 mg three times daily~Gabapentin: For the first week, one 400 mg Gabapentin capsule taken 3 times per day. For the second week, two 400 mg Gabapentin capsules taken 3 times per day. For the third week through the eighth week, three 400 mg Gabapentin capsules taken 3 times per day. For the ninth and last week, two 400 mg Gabapentin capsules taken 3 times per day for 3 days, then one 400 mg Gabapentin capsule taken 3 times per day for 4 days. Placebo study medication appears identical to active medication and is prescribed with an identical dosing schedule."
10871838|NCT00420771|OG001|Outcome|Placebo|"Placebo condition received pills identical in appearance to experimental arm.~Gabapentin: For the first week, one 400 mg Gabapentin capsule taken 3 times per day. For the second week, two 400 mg Gabapentin capsules taken 3 times per day. For the third week through the eighth week, three 400 mg Gabapentin capsules taken 3 times per day. For the ninth and last week, two 400 mg Gabapentin capsules taken 3 times per day for 3 days, then one 400 mg Gabapentin capsule taken 3 times per day for 4 days. Placebo study medication appears identical to active medication and is prescribed with an identical dosing schedule."
10871839|NCT00420771|EG000|Reported Event|Gabapentin|gabapentin treatment 1200 mg three times daily
10871840|NCT00420771|EG001|Reported Event|Placebo|Placebo condition received pills identical in appearance to experimental arm.
10871841|NCT00420784|BG000|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
10871842|NCT00420784|BG001|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10871843|NCT00420784|BG002|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
10871844|NCT00420784|BG003|Baseline|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10871845|NCT00420784|BG004|Baseline|Total|Total of all reporting groups
10871846|NCT00420784|FG000|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
10871847|NCT00420784|FG001|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10871848|NCT00420784|FG002|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
10871849|NCT00420784|FG003|Participant Flow|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10871850|NCT00420784|OG000|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
10871851|NCT00420784|OG001|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10871852|NCT00420784|OG002|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
10871853|NCT00420784|OG003|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10871854|NCT00420784|OG000|Outcome|Telaprevir|"All subjects who received single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week reporting group and for 24 weeks in Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week reporting groups."
10871855|NCT00420784|EG000|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
10871856|NCT00420784|EG001|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10871857|NCT00420784|EG002|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
10871858|NCT00420784|EG003|Reported Event|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10871859|NCT00420849|BG000|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
10871860|NCT00420849|FG000|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
10871861|NCT00420849|OG000|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
10871862|NCT00420849|OG000|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
10871863|NCT00420849|OG001|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
10871864|NCT00420849|OG002|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
10871865|NCT00420849|EG000|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
10879278|NCT00456599|FG000|Participant Flow|Gemcitabine and Oxaliplatin With Radiation Therapy|Gemcitabine and Oxaliplatin with radiation therapy in localized pancreatic cancer.
10871866|NCT00420927|BG000|Baseline|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
10871867|NCT00420927|BG001|Baseline|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo(PBO) during Period 1
10871868|NCT00420927|BG002|Baseline|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
10871869|NCT00420927|BG003|Baseline|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
10871870|NCT00420927|BG004|Baseline|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
10871871|NCT00420927|BG005|Baseline|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
10871872|NCT00420927|BG006|Baseline|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
10871873|NCT00420927|BG007|Baseline|Total|Total of all reporting groups
10871874|NCT00420927|FG000|Participant Flow|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
10871875|NCT00420927|FG001|Participant Flow|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo during Period 1
10871876|NCT00420927|FG002|Participant Flow|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
10871877|NCT00420927|FG003|Participant Flow|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
10871878|NCT00420927|FG004|Participant Flow|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
10871879|NCT00420927|FG005|Participant Flow|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
10871880|NCT00420927|FG006|Participant Flow|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
10871881|NCT00420927|OG000|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
10871882|NCT00420927|OG001|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
10871883|NCT00420927|OG002|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
10871884|NCT00420927|OG003|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
10871885|NCT00420927|OG004|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
10871886|NCT00420927|EG000|Reported Event|ADA+MTX/PBO+MTX (Arm 1)|Blinded combination ADA+MTX therapy during Period 1 and blinded MTX monotherapy during Period 2
10871887|NCT00420927|EG001|Reported Event|ADA+MTX/ADA+MTX (Arm 2)|Blinded combination ADA+MTX therapy during Period 1 and Period 2
10871888|NCT00420927|EG002|Reported Event|ADA+MTX/OL ADA+MTX (Arm 3)|Blinded combination therapy during Period 1, open-label combination therapy during Period 2
10871889|NCT00420927|EG003|Reported Event|PBO+MTX/PBO+MTX (Arm 4)|Blinded MTX monotherapy during Period 1 and Period 2
10871890|NCT00420927|EG004|Reported Event|PBO+MTX/OL ADA+MTX (Arm 5)|Blinded MTX monotherapy during Period 1, open-label combination therapy during Period 2
10871891|NCT00420927|EG005|Reported Event|Period 1 ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
10871892|NCT00420927|EG006|Reported Event|Period 1 PBO+MTX|Combination therapy with methotrexate (MTX) and blinded placebo (PBO) during Period 1
10871893|NCT00420992|BG000|Baseline|ALO-01|
10871894|NCT00420992|BG001|Baseline|Placebo|
10871895|NCT00420992|BG002|Baseline|Total|Total of all reporting groups
10871896|NCT00420992|FG000|Participant Flow|ALO-01|
10871897|NCT00420992|FG001|Participant Flow|Placebo|
10871898|NCT00420992|OG000|Outcome|ALO-01|
10871899|NCT00420992|OG001|Outcome|Placebo|
10871900|NCT00420992|EG000|Reported Event|ALO-01|
10871901|NCT00420992|EG001|Reported Event|Placebo|
10871902|NCT00420992|EG002|Reported Event|Titration ALO-01|Open-label ALO-01
10871903|NCT00421148|BG000|Baseline|Infants: Placebo|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871904|NCT00421148|BG001|Baseline|Infants: Sugammadex 0.5 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871905|NCT00421148|BG002|Baseline|Infants: Sugammadex 1 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871906|NCT00421148|BG003|Baseline|Infants: Sugammadex 2 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871907|NCT00421148|BG004|Baseline|Children: Placebo|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871908|NCT00421148|BG005|Baseline|Children: Sugammadex 0.5 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871909|NCT00421148|BG006|Baseline|Children: Sugammadex 1 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered
10977134|NCT00943826|FG001|Participant Flow|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
10977135|NCT00943826|OG000|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
10977136|NCT00943826|OG001|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
10977137|NCT00943826|OG000|Outcome|Bevacizumab + RT +Temozolomide|In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
10977138|NCT00943826|EG000|Reported Event|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
10977139|NCT00943826|EG001|Reported Event|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
10977140|NCT00943878|BG000|Baseline|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977141|NCT00943878|BG001|Baseline|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
10977142|NCT00943878|BG002|Baseline|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
10977143|NCT00943878|BG003|Baseline|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977144|NCT00943878|BG004|Baseline|Total|Total of all reporting groups
10977145|NCT00943878|FG000|Participant Flow|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977146|NCT00943878|FG001|Participant Flow|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
10977147|NCT00943878|FG002|Participant Flow|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
10977148|NCT00943878|FG003|Participant Flow|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977149|NCT00943878|OG000|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977150|NCT00943878|OG001|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
10977151|NCT00943878|OG002|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
10977152|NCT00943878|OG003|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977153|NCT00943878|EG000|Reported Event|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977154|NCT00943878|EG001|Reported Event|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
10977155|NCT00943878|EG002|Reported Event|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
10977156|NCT00943878|EG003|Reported Event|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
10977157|NCT00943904|BG000|Baseline|Interstim Stimulation|"Patients who receive the interstim implant in order to evaluate effectiveness of treatment~Interstim implant for SNS: stimulates third sacral nerve root"
10977158|NCT00943904|FG000|Participant Flow|Interstim Stimulation|"Patients who receive the interstim implant in order to evaluate effectiveness of treatment~Interstim implant for SNS: stimulates third sacral nerve root"
10977159|NCT00943904|OG000|Outcome|Interstim Stimulation|"Patients who receive the interstim implant in order to evaluate effectiveness of treatment~Interstim implant for SNS: stimulates third sacral nerve root"
10977160|NCT00943904|EG000|Reported Event|Interstim Stimulation|"Patients who receive the interstim implant in order to evaluate effectiveness of treatment~Interstim implant for SNS: stimulates third sacral nerve root"
10977161|NCT00943917|BG000|Baseline|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
10977162|NCT00943917|BG001|Baseline|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
10977163|NCT00943917|BG002|Baseline|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
10977164|NCT00943917|BG003|Baseline|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
10977165|NCT00943917|BG004|Baseline|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
10977166|NCT00943917|BG005|Baseline|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
10977167|NCT00943917|BG006|Baseline|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
10977168|NCT00943917|BG007|Baseline|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
10977169|NCT00943917|BG008|Baseline|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
10977170|NCT00943917|BG009|Baseline|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
10977171|NCT00943917|BG010|Baseline|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
10977172|NCT00943917|BG011|Baseline|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
10977173|NCT00943917|BG012|Baseline|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
10977174|NCT00943917|BG013|Baseline|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
10977175|NCT00943917|BG014|Baseline|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
10977176|NCT00943917|BG015|Baseline|Total|Total of all reporting groups
10977177|NCT00943917|FG000|Participant Flow|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
10977178|NCT00943917|FG001|Participant Flow|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
10977179|NCT00943917|FG002|Participant Flow|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
10977180|NCT00943917|FG003|Participant Flow|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
10977181|NCT00943917|FG004|Participant Flow|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
10977182|NCT00943917|FG005|Participant Flow|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
10977183|NCT00943917|FG006|Participant Flow|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
10977184|NCT00943917|FG007|Participant Flow|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
10977185|NCT00943917|FG008|Participant Flow|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
10977186|NCT00943917|FG009|Participant Flow|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
10977187|NCT00943917|FG010|Participant Flow|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
10871910|NCT00421148|BG007|Baseline|Children: Sugammadex 2 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871911|NCT00421148|BG008|Baseline|Children: Sugammadex 4 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871912|NCT00421148|BG009|Baseline|Adolescents: Placebo|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871913|NCT00421148|BG010|Baseline|Adolescents: Sugammadex 0.5 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871914|NCT00421148|BG011|Baseline|Adolescents: Sugammadex 1 mg/kg|Adolescents participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871915|NCT00421148|BG012|Baseline|Adolescents: Sugammadex 2 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871916|NCT00421148|BG013|Baseline|Adolescents: Sugammadex 4 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871917|NCT00421148|BG014|Baseline|Adults: Placebo|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871918|NCT00421148|BG015|Baseline|Adults: Sugammadex 0.5 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871919|NCT00421148|BG016|Baseline|Adults: Sugammadex 1 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871920|NCT00421148|BG017|Baseline|Adults: Sugammadex 2 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871921|NCT00421148|BG018|Baseline|Adults: Sugammadex 4 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871922|NCT00421148|BG019|Baseline|Infants: Sugammadex 4 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871923|NCT00421148|BG020|Baseline|Total|Total of all reporting groups
10871924|NCT00421148|FG000|Participant Flow|Infants: Placebo|Infant participants received an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871925|NCT00421148|FG001|Participant Flow|Infants: Sugammadex 0.5 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871926|NCT00421148|FG002|Participant Flow|Infants: Sugammadex 1 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871927|NCT00421148|FG003|Participant Flow|Infants: Sugammadex 2 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871928|NCT00421148|FG004|Participant Flow|Infants: Sugammadex 4 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871929|NCT00421148|FG005|Participant Flow|Children: Placebo|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871930|NCT00421148|FG006|Participant Flow|Children: Sugammadex 0.5 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871931|NCT00421148|FG007|Participant Flow|Children: Sugammadex 1 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered
10871932|NCT00421148|FG008|Participant Flow|Children: Sugammadex 2 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871933|NCT00421148|FG009|Participant Flow|Children: Sugammadex 4 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871934|NCT00421148|FG010|Participant Flow|Adolescents: Placebo|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871935|NCT00421148|FG011|Participant Flow|Adolescents: Sugammadex 0.5 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871936|NCT00421148|FG012|Participant Flow|Adolescents: Sugammadex 1 mg/kg|Adolescents participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871937|NCT00421148|FG013|Participant Flow|Adolescents: Sugammadex 2 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871938|NCT00421148|FG014|Participant Flow|Adolescents: Sugammadex 4 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871939|NCT00421148|FG015|Participant Flow|Adults: Placebo|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871940|NCT00421148|FG016|Participant Flow|Adults: Sugammadex 0.5 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871941|NCT00421148|FG017|Participant Flow|Adults: Sugammadex 1 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871942|NCT00421148|FG018|Participant Flow|Adults: Sugammadex 2 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871943|NCT00421148|FG019|Participant Flow|Adults: Sugammadex 4 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871944|NCT00421148|OG000|Outcome|Infants: Placebo|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871945|NCT00421148|OG001|Outcome|Infants: Sugammadex 0.5 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871946|NCT00421148|OG002|Outcome|Infants: Sugammadex 1 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871947|NCT00421148|OG003|Outcome|Infants: Sugammadex 2 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871948|NCT00421148|OG004|Outcome|Children: Placebo|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871949|NCT00421148|OG005|Outcome|Children: Sugammadex 0.5 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871950|NCT00421148|OG006|Outcome|Children: Sugammadex 1 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered
10871951|NCT00421148|OG007|Outcome|Children: Sugammadex 2 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871952|NCT00421148|OG008|Outcome|Children: Sugammadex 4 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871953|NCT00421148|OG009|Outcome|Adolescents: Placebo|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871954|NCT00421148|OG010|Outcome|Adolescents: Sugammadex 0.5 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871955|NCT00421148|OG011|Outcome|Adolescents: Sugammadex 1 mg/kg|Adolescents participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871956|NCT00421148|OG012|Outcome|Adolescents: Sugammadex 2 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871957|NCT00421148|OG013|Outcome|Adolescents: Sugammadex 4 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871958|NCT00421148|OG014|Outcome|Adults: Placebo|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871959|NCT00421148|OG015|Outcome|Adults: Sugammadex 0.5 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871960|NCT00421148|OG016|Outcome|Adults: Sugammadex 1 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871961|NCT00421148|OG017|Outcome|Adults: Sugammadex 2 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871962|NCT00421148|OG018|Outcome|Adults: Sugammadex 4 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871963|NCT00421148|OG019|Outcome|Infants: Sugammadex 4 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871964|NCT00421148|EG000|Reported Event|Infants: Placebo|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered.
10871965|NCT00421148|EG001|Reported Event|Infants: Sugammadex .0.5 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871966|NCT00421148|EG002|Reported Event|Infants: Sugammadex 1 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10977188|NCT00943917|FG011|Participant Flow|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
10977189|NCT00943917|FG012|Participant Flow|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
10977190|NCT00943917|FG013|Participant Flow|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
10977191|NCT00943917|FG014|Participant Flow|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
10977192|NCT00943917|OG000|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
10977193|NCT00943917|OG001|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
10977194|NCT00943917|OG002|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
10977195|NCT00943917|OG000|Outcome|ITCA 650 20/20|Stage II & Stage II Continuation
10977196|NCT00943917|OG001|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
10977197|NCT00943917|OG002|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
10977198|NCT00943917|OG003|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
10977199|NCT00943917|OG004|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
10977200|NCT00943917|OG005|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
10977201|NCT00943917|OG000|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
10977202|NCT00943917|OG001|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
10977203|NCT00943917|OG002|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
10977204|NCT00943917|OG003|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
10977205|NCT00943917|OG004|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
10977206|NCT00943917|OG005|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
10977207|NCT00943917|OG000|Outcome|ITCA 650 20/20|Stage II Continuation
10977208|NCT00943917|EG000|Reported Event|ITCA 650 20 mcg/Day|ITCA 650 20 mcg/day continuous exenatide
10977209|NCT00943917|EG001|Reported Event|ITCA 650 40 mcg/Day|ITCA 650 40 mcg/day continuous exenatide
10977210|NCT00943917|EG002|Reported Event|Exenatide Injection|exenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks
10977211|NCT00943917|EG003|Reported Event|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
10977212|NCT00943917|EG004|Reported Event|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
10977213|NCT00943917|EG005|Reported Event|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
10977214|NCT00943917|EG006|Reported Event|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
10977215|NCT00943917|EG007|Reported Event|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
10977216|NCT00943917|EG008|Reported Event|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
10977217|NCT00943917|EG009|Reported Event|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48
10977218|NCT00943917|EG010|Reported Event|ITCA 650 20/60 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48
10977219|NCT00943917|EG011|Reported Event|ITCA 650 40/40 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
10977220|NCT00943917|EG012|Reported Event|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48
10977221|NCT00943917|EG013|Reported Event|Ex Inj/ITCA 40 Continuation|Exenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
10977222|NCT00943917|EG014|Reported Event|Ex Inj/ITCA 650 60 Continutation|Exenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48
10977223|NCT00944021|BG000|Baseline|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
10977224|NCT00944021|BG001|Baseline|PA-824 100mg/qd|PA-824 : 100mg oral tablet
10977225|NCT00944021|BG002|Baseline|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
10977226|NCT00944021|BG003|Baseline|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
10977227|NCT00944021|BG004|Baseline|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
10977228|NCT00944021|BG005|Baseline|Total|Total of all reporting groups
10977229|NCT00944021|FG000|Participant Flow|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
10977230|NCT00944021|FG001|Participant Flow|PA-824 100mg/qd|PA-824 : 100mg oral tablet
10977231|NCT00944021|FG002|Participant Flow|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
10977232|NCT00944021|FG003|Participant Flow|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
10977233|NCT00944021|FG004|Participant Flow|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
10977234|NCT00944021|OG000|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
10977235|NCT00944021|OG001|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
10977236|NCT00944021|OG002|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
10977237|NCT00944021|OG003|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
10977238|NCT00944021|OG004|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
10977239|NCT00944021|EG000|Reported Event|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
10977240|NCT00944021|EG001|Reported Event|PA-824 100mg/qd|PA-824 : 100mg oral tablet
10977241|NCT00944021|EG002|Reported Event|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
10977242|NCT00944021|EG003|Reported Event|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
10977243|NCT00944021|EG004|Reported Event|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
10871967|NCT00421148|EG003|Reported Event|Infants: Sugammadex 2 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871968|NCT00421148|EG004|Reported Event|Infants: Sugammadex 4 mg/kg|Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871969|NCT00421148|EG005|Reported Event|Children: Placebo|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered
10871970|NCT00421148|EG006|Reported Event|Children: Sugammadex 0.5 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871971|NCT00421148|EG007|Reported Event|Children: Sugammadex 1 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871972|NCT00421148|EG008|Reported Event|Children: Sugammadex 2 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871973|NCT00421148|EG009|Reported Event|Children: Sugammadex 4 mg/kg|Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871974|NCT00421148|EG010|Reported Event|Adolescents: Placebo|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered
10871975|NCT00421148|EG011|Reported Event|Adolescents: Sugammadex 0.5 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871976|NCT00421148|EG012|Reported Event|Adolescents: Sugammadex 1 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871977|NCT00421148|EG013|Reported Event|Adolescents: Sugammadex 2 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871978|NCT00421148|EG014|Reported Event|Adolescents: Sugammadex 4 mg/kg|Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871979|NCT00421148|EG015|Reported Event|Adults: Placebo|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered
10871980|NCT00421148|EG016|Reported Event|Adults: Sugammadex 0.5 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered.
10871981|NCT00421148|EG017|Reported Event|Adults: Sugammadex 1 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered.
10871982|NCT00421148|EG018|Reported Event|Adults: Sugammadex 2 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered.
10871983|NCT00421148|EG019|Reported Event|Adults: Sugammadex 4 mg/kg|Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered.
10871984|NCT00421174|BG000|Baseline|Etanercept|Etanercept plus corticosteroids
10871985|NCT00421174|BG001|Baseline|Placebo|Placebo plus Corticosteroids
10871986|NCT00421174|BG002|Baseline|Total|Total of all reporting groups
10871987|NCT00421174|FG000|Participant Flow|Etanercept|Etanercept plus corticosteroids
10871988|NCT00421174|FG001|Participant Flow|Placebo|Placebo plus Corticosteroids
10871989|NCT00421174|OG000|Outcome|Etanercept|Etanercept plus corticosteroids
10871990|NCT00421174|OG001|Outcome|Placebo|Placebo plus Corticosteroids
10871991|NCT00421174|EG000|Reported Event|Etanercept|Etanercept plus corticosteroids
10871992|NCT00421174|EG001|Reported Event|Placebo|Placebo plus Corticosteroids
10871993|NCT00421304|BG000|Baseline|Placebo|Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
10871994|NCT00421304|BG001|Baseline|Motavizumab 30 mg/kg|Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
10871995|NCT00421304|BG002|Baseline|Motavizumab 100 mg/kg|Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
10871996|NCT00421304|BG003|Baseline|Total|Total of all reporting groups
10871997|NCT00421304|FG000|Participant Flow|Placebo|Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
10871998|NCT00421304|FG001|Participant Flow|Motavizumab 30 mg/kg|Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
10871999|NCT00421304|FG002|Participant Flow|Motavizumab 100 mg/kg|Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
10872000|NCT00421304|OG000|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
10872001|NCT00421304|OG001|Outcome|Motavizumab 30 mg/kg|Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
10872002|NCT00421304|OG002|Outcome|Motavizumab 100 mg/kg|Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
10872003|NCT00421304|OG000|Outcome|Motavizumab 30 mg/kg|Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
10872004|NCT00421304|OG001|Outcome|Motavizumab 100 mg/kg|Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
10872005|NCT00421304|EG000|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
10872006|NCT00421304|EG001|Reported Event|Motavizumab 30 mg/kg|Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
10872007|NCT00421304|EG002|Reported Event|Motavizumab 100 mg/kg|Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.
10977244|NCT00944034|BG000|Baseline|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977245|NCT00944034|BG001|Baseline|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977246|NCT00944034|BG002|Baseline|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977247|NCT00944034|BG003|Baseline|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977248|NCT00944034|BG004|Baseline|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
10977249|NCT00944034|BG005|Baseline|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
10977250|NCT00944034|BG006|Baseline|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
10977251|NCT00944034|BG007|Baseline|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977252|NCT00944034|BG008|Baseline|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977253|NCT00944034|BG009|Baseline|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
10977254|NCT00944034|BG010|Baseline|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
10977255|NCT00944034|BG011|Baseline|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
10977256|NCT00944034|BG012|Baseline|Total|Total of all reporting groups
10977257|NCT00944034|FG000|Participant Flow|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age
10977258|NCT00944034|FG001|Participant Flow|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977259|NCT00944034|FG002|Participant Flow|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977260|NCT00944034|FG003|Participant Flow|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977261|NCT00944034|FG004|Participant Flow|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
10977262|NCT00944034|FG005|Participant Flow|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
10977263|NCT00944034|FG006|Participant Flow|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
10977264|NCT00944034|FG007|Participant Flow|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
11348156|NCT04207333|EG000|Reported Event|Prolonged Sitting With Mental Stress|"Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.~Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes"
10977265|NCT00944034|FG008|Participant Flow|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977266|NCT00944034|FG009|Participant Flow|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
10977267|NCT00944034|FG010|Participant Flow|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
10977268|NCT00944034|FG011|Participant Flow|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
10977269|NCT00944034|OG000|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977270|NCT00944034|OG001|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977271|NCT00944034|OG002|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977272|NCT00944034|OG000|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977273|NCT00944034|OG001|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
10977274|NCT00944034|OG002|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
10977275|NCT00944034|OG000|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
10977276|NCT00944034|OG001|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977277|NCT00944034|OG002|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977278|NCT00944034|OG003|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977279|NCT00944034|OG004|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
10977280|NCT00944034|OG005|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
10977281|NCT00944034|OG006|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
10977282|NCT00944034|OG007|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977283|NCT00944034|OG008|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977284|NCT00944034|OG001|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977285|NCT00944034|OG002|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
10977286|NCT00944034|OG003|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
10977287|NCT00944034|OG000|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977288|NCT00944034|OG001|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977289|NCT00944034|OG002|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
10977290|NCT00944034|OG003|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
10977291|NCT00944034|OG004|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977292|NCT00944034|OG005|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977293|NCT00944034|OG006|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
10977294|NCT00944034|OG007|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
10977295|NCT00944034|OG000|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
10977296|NCT00944034|OG001|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
10977297|NCT00944034|OG002|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
10977298|NCT00944034|EG000|Reported Event|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977299|NCT00944034|EG001|Reported Event|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977300|NCT00944034|EG002|Reported Event|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977301|NCT00944034|EG003|Reported Event|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
10977302|NCT00944034|EG004|Reported Event|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
10977303|NCT00944034|EG005|Reported Event|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
10977304|NCT00944034|EG006|Reported Event|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
10977305|NCT00944034|EG007|Reported Event|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
10977306|NCT00944034|EG008|Reported Event|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
10977307|NCT00944034|EG009|Reported Event|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
10977308|NCT00944034|EG010|Reported Event|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
10977309|NCT00944034|EG011|Reported Event|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
10872008|NCT00421343|BG000|Baseline|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
10872009|NCT00421343|FG000|Participant Flow|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
10872010|NCT00421343|OG000|Outcome|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
10872011|NCT00421343|EG000|Reported Event|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
10872012|NCT00421408|BG000|Baseline|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
10872013|NCT00421408|BG001|Baseline|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
10872014|NCT00421408|BG002|Baseline|Total|Total of all reporting groups
10872015|NCT00421408|FG000|Participant Flow|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
10872016|NCT00421408|FG001|Participant Flow|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
10872017|NCT00421408|OG000|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
10872018|NCT00421408|OG001|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
10872019|NCT00421408|EG000|Reported Event|Placebo Carbohydrate Powder 40 g Daily|
10872020|NCT00421408|EG001|Reported Event|Protein Powder 40 g Daily|
10872021|NCT00421603|BG000|Baseline|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
10872022|NCT00421603|BG001|Baseline|Placebo|Placebo daily dose
10872023|NCT00421603|BG002|Baseline|Total|Total of all reporting groups
10872024|NCT00421603|FG000|Participant Flow|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
10872025|NCT00421603|FG001|Participant Flow|Placebo|Placebo daily dose
10872026|NCT00421603|OG000|Outcome|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
10872027|NCT00421603|OG001|Outcome|Placebo|Placebo daily dose
10872028|NCT00421603|EG000|Reported Event|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
10872029|NCT00421603|EG001|Reported Event|Placebo|Placebo daily dose
10872030|NCT00421707|BG000|Baseline|Sequence A/X/B|As per the treatment sequence A/X/B, during period 1, eligible participants received GW876008 125 mg (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks, followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received matching placebo (B) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose pharmacokinetic (PK) blood sample.
10872031|NCT00421707|BG001|Baseline|Sequence B/X/A|As per the treatment sequence B/X/A, during period 1, eligible participants received matching placebo (B) once daily for 6 weeks followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received GW876008 125 mg (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872032|NCT00421707|BG002|Baseline|Total|Total of all reporting groups
10872033|NCT00421707|FG000|Participant Flow|Sequence A/X/B|As per the treatment sequence A/X/B, during period 1, eligible participants received GW876008 125 milligram (mg) (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks, followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received matching placebo (B) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose pharmacokinetic (PK) blood sample.
10872034|NCT00421707|FG001|Participant Flow|Sequence B/X/A|As per the treatment sequence B/X/A, during period 1, eligible participants received matching placebo (B) once daily for 6 weeks followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received GW876008 125 mg (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872035|NCT00421707|OG000|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872036|NCT00421707|OG001|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872037|NCT00421707|OG002|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872038|NCT00421707|OG000|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872039|NCT00421707|EG000|Reported Event|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872040|NCT00421707|EG001|Reported Event|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872041|NCT00421707|EG002|Reported Event|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
10872042|NCT00421733|BG000|Baseline|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
10872043|NCT00421733|BG001|Baseline|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
10872044|NCT00421733|BG002|Baseline|Placebo|Two placebo capsules per dose
10872045|NCT00421733|BG003|Baseline|Total|Total of all reporting groups
10872046|NCT00421733|FG000|Participant Flow|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
10872047|NCT00421733|FG001|Participant Flow|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
10872048|NCT00421733|FG002|Participant Flow|Placebo|Two placebo capsules per dose
10872049|NCT00421733|OG000|Outcome|Placebo|Two placebo capsules per dose (N=88)
10872050|NCT00421733|OG001|Outcome|Combined Paricalcitol 1 Mcg and 2 Mcg|Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).
10872051|NCT00421733|OG002|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
10872052|NCT00421733|OG003|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
10872053|NCT00421733|OG000|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
10872054|NCT00421733|OG001|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
10872055|NCT00421733|OG002|Outcome|Placebo|Two placebo capsules per dose
10872056|NCT00421733|EG000|Reported Event|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
10872057|NCT00421733|EG001|Reported Event|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
10872058|NCT00421733|EG002|Reported Event|Placebo|Two placebo capsules per dose
10872059|NCT00421889|BG000|Baseline|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872060|NCT00421889|BG001|Baseline|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872061|NCT00421889|BG002|Baseline|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872062|NCT00421889|BG003|Baseline|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872063|NCT00421889|BG004|Baseline|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872064|NCT00421889|BG005|Baseline|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872065|NCT00421889|BG006|Baseline|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
10872066|NCT00421889|BG007|Baseline|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
10872067|NCT00421889|BG008|Baseline|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
10872068|NCT00421889|BG009|Baseline|Total|Total of all reporting groups
10872069|NCT00421889|FG000|Participant Flow|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 (area under the curve) administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872070|NCT00421889|FG001|Participant Flow|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872071|NCT00421889|FG002|Participant Flow|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872072|NCT00421889|FG003|Participant Flow|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872073|NCT00421889|FG004|Participant Flow|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872074|NCT00421889|FG005|Participant Flow|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872075|NCT00421889|FG006|Participant Flow|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
10872076|NCT00421889|FG007|Participant Flow|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
10872077|NCT00421889|FG008|Participant Flow|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
10872078|NCT00421889|OG000|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
10872079|NCT00421889|OG000|Outcome|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872080|NCT00421889|OG001|Outcome|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872081|NCT00421889|OG002|Outcome|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872082|NCT00421889|OG003|Outcome|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872083|NCT00421889|OG004|Outcome|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872084|NCT00421889|OG005|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10977310|NCT00944047|BG000|Baseline|Intervention Arm|"Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery~nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks~trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks~Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles~cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)~Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.~Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
10977311|NCT00944047|FG000|Participant Flow|Intervention Arm|"Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery~nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks~trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks~Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles~cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)~Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.~Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
10977312|NCT00944047|OG000|Outcome|Intervention Arm|"Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery~nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks~trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks~Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles~cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)~Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.~Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
10977313|NCT00944047|EG000|Reported Event|Intervention Arm|"Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery~nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks~trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks~Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles~cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)~Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.~Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
10977314|NCT00944073|BG000|Baseline|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10977315|NCT00944073|BG001|Baseline|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10977316|NCT00944073|BG002|Baseline|Total|Total of all reporting groups
10977317|NCT00944073|FG000|Participant Flow|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10977318|NCT00944073|FG001|Participant Flow|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10977319|NCT00944073|OG000|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10977320|NCT00944073|OG001|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10977321|NCT00944073|EG000|Reported Event|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10977322|NCT00944073|EG001|Reported Event|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10977323|NCT00944125|BG000|Baseline|All Study Participants|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Arm A: Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. Randomized to Arm B: Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
10977324|NCT00944125|FG000|Participant Flow|Dual Site LV Pacing First, Then BiV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
10977325|NCT00944125|FG001|Participant Flow|BiV Pacing First, Then Dual Site LV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
10977326|NCT00944125|OG000|Outcome|Dual Site LV Pacing|
10977327|NCT00944125|OG001|Outcome|BiV Pacing|
10872085|NCT00421889|OG006|Outcome|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
10872086|NCT00421889|OG007|Outcome|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
10872087|NCT00421889|OG008|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
10872088|NCT00421889|OG000|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872089|NCT00421889|OG001|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
10872090|NCT00421889|OG002|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
10872091|NCT00421889|OG000|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
10872092|NCT00421889|OG001|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
10872093|NCT00421889|OG002|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
10872094|NCT00421889|OG003|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
10872095|NCT00421889|OG004|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
10872096|NCT00421889|EG000|Reported Event|Part A: Dose Escalation (N=23)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872097|NCT00421889|EG001|Reported Event|Part B: Ovarian Cancer MTD (N=35)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
10872098|NCT00421889|EG002|Reported Event|Part C: 3-6 Hours Infusion (N=7)|PXD: 1000 mg/m² was administered as a 3 or 6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
10872099|NCT00421889|EG003|Reported Event|Part D: Bladder Cancer MTD (N=15)|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
10872100|NCT00421928|BG000|Baseline|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
10872101|NCT00421928|BG001|Baseline|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
10872102|NCT00421928|BG002|Baseline|Placebo|Matching Placebo twice daily (BID)
10872103|NCT00421928|BG003|Baseline|Total|Total of all reporting groups
10872104|NCT00421928|FG000|Participant Flow|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
10872105|NCT00421928|FG001|Participant Flow|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
10872106|NCT00421928|FG002|Participant Flow|Placebo|Matching Placebo twice daily (BID)
10872107|NCT00421928|OG000|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
10872108|NCT00421928|OG001|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
10872109|NCT00421928|OG002|Outcome|Placebo|Matching Placebo twice daily (BID)
10872110|NCT00421928|EG000|Reported Event|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
10872111|NCT00421928|EG001|Reported Event|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
10872112|NCT00421928|EG002|Reported Event|Placebo|Matching Placebo twice daily (BID)
10872113|NCT00421993|BG000|Baseline|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
10872114|NCT00421993|BG001|Baseline|Adapalene Gel|Adapalene Topical Gel
10872115|NCT00421993|BG002|Baseline|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
10872116|NCT00421993|BG003|Baseline|Gel Vehicle|Topical Gel Vehicle
10872117|NCT00421993|BG004|Baseline|Total|Total of all reporting groups
10872118|NCT00421993|FG000|Participant Flow|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
10872119|NCT00421993|FG001|Participant Flow|Adapalene Gel|Adapalene Topical Gel
10872120|NCT00421993|FG002|Participant Flow|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
10872121|NCT00421993|FG003|Participant Flow|Gel Vehicle|Topical Gel Vehicle
10872122|NCT00421993|OG000|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
10872123|NCT00421993|OG001|Outcome|Adapalene Gel|Adapalene Topical Gel
10872124|NCT00421993|OG002|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
10872125|NCT00421993|OG003|Outcome|Gel Vehicle|Topical Gel Vehicle
10872126|NCT00421993|EG000|Reported Event|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
10872127|NCT00421993|EG001|Reported Event|Adapalene Gel|Adapalene Topical Gel
10977328|NCT00944125|EG000|Reported Event|Dual Site LV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
10977329|NCT00944125|EG001|Reported Event|BiV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
10977330|NCT00944450|BG000|Baseline|All Participants|
10977331|NCT00944450|FG000|Participant Flow|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
10977332|NCT00944450|FG001|Participant Flow|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
10977333|NCT00944450|OG000|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
10977334|NCT00944450|OG001|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
10977335|NCT00944450|EG000|Reported Event|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
10977336|NCT00944450|EG001|Reported Event|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
10977337|NCT00944554|BG000|Baseline|Placebo|"Group given placebo.~Placebo: Varenicline and placebo given twice a day or five weeks."
10977338|NCT00944554|BG001|Baseline|Varenicline|"Experimental group given varenicline dosing.~Varenicline: Varenicline and placebo given twice a day or five weeks."
10977339|NCT00944554|BG002|Baseline|Total|Total of all reporting groups
10977340|NCT00944554|FG000|Participant Flow|Placebo|Group given placebo twice a day for 5 weeks.
10977341|NCT00944554|FG001|Participant Flow|Varenicline|Experimental group given varenicline twice a day or five weeks.
10977342|NCT00944554|OG000|Outcome|Placebo|Group given placebo twice a day or five weeks.
10977343|NCT00944554|OG001|Outcome|Varenicline|Experimental group given varenicline twice a day or five weeks.
10977344|NCT00944554|EG000|Reported Event|Placebo|"Group given placebo.~Placebo: Varenicline and placebo given twice a day or five weeks."
10977345|NCT00944554|EG001|Reported Event|Varenicline|"Experimental group given varenicline dosing.~Varenicline: Varenicline and placebo given twice a day or five weeks."
10977346|NCT00944645|BG000|Baseline|All Participants|Includes all participants from Both treatment groups; MK0524A Phase III tablet and MK0524A New Site tablet
10977347|NCT00944645|FG000|Participant Flow|MK0524A Phase III Tablet Then MK0524A New Site Tablet|MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)/MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)
10977348|NCT00944645|FG001|Participant Flow|MK0524A New Site Tablet Then MK0524A Phase III Tablet|MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)/ MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)
10977349|NCT00944645|OG000|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
10977350|NCT00944645|OG001|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
10977351|NCT00944645|EG000|Reported Event|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
10977352|NCT00944645|EG001|Reported Event|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
10977353|NCT00944658|BG000|Baseline|Placebo|"placebo twice a day for 12 weeks, 4 weeks follow up~Placebo (sugar pill): twice a day"
10977354|NCT00944658|BG001|Baseline|Apremilast|"30 mg twice a day for 12 weeks, 4 weeks follow up~Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks"
10977355|NCT00944658|BG002|Baseline|Total|Total of all reporting groups
10977356|NCT00944658|FG000|Participant Flow|Placebo|"placebo twice a day for 12 weeks, 4 weeks follow up~Placebo (sugar pill): twice a day"
10977357|NCT00944658|FG001|Participant Flow|Apremilast|"30 mg twice a day for 12 weeks, 4 weeks follow up~Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks"
10977358|NCT00944658|OG000|Outcome|Placebo|"placebo twice a day for 12 weeks, 4 weeks follow up~Placebo (sugar pill): twice a day"
10977359|NCT00944658|OG001|Outcome|Apremilast|"30 mg twice a day for 12 weeks, 4 weeks follow up~Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks"
10977360|NCT00944658|EG000|Reported Event|Placebo|"placebo twice a day for 12 weeks, 4 weeks follow up~Placebo (sugar pill): twice a day"
10977361|NCT00944658|EG001|Reported Event|Apremilast|"30 mg twice a day for 12 weeks, 4 weeks follow up~Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks"
10977362|NCT00944671|BG000|Baseline|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
10977363|NCT00944671|BG001|Baseline|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
10977364|NCT00944671|BG002|Baseline|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
10977365|NCT00944671|BG003|Baseline|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
10977366|NCT00944671|BG004|Baseline|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
10977367|NCT00944671|BG005|Baseline|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
10977368|NCT00944671|BG006|Baseline|Total|Total of all reporting groups
10977369|NCT00944671|FG000|Participant Flow|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
10977370|NCT00944671|FG001|Participant Flow|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
10977371|NCT00944671|FG002|Participant Flow|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
10977372|NCT00944671|FG003|Participant Flow|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
10977373|NCT00944671|FG004|Participant Flow|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
10977374|NCT00944671|FG005|Participant Flow|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
10977375|NCT00944671|OG000|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
10977376|NCT00944671|OG001|Outcome|Famotidine/Antacid Combination Tablet With Water|
10977377|NCT00944671|OG000|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
10977378|NCT00944671|EG000|Reported Event|Famotidine/Antacid Combination Tablet With Water|Famotidine/antacid combination tablet with 120 mL of water
10977379|NCT00944671|EG001|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet Without Water|Famotidine/antacid combination EZ Chew tablet without water
10977380|NCT00944671|EG002|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water
10977381|NCT00944697|BG000|Baseline|Placebo Tablets|A placebo tablet to match the active reference treatment
10977382|NCT00944697|BG001|Baseline|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
10977383|NCT00944697|BG002|Baseline|Total|Total of all reporting groups
10977384|NCT00944697|FG000|Participant Flow|Placebo Tablets|A placebo tablet to match the active reference treatment
10977385|NCT00944697|FG001|Participant Flow|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
10977386|NCT00944697|OG000|Outcome|Placebo Tablets|A placebo tablet to match the active reference treatment
10977387|NCT00944697|OG001|Outcome|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
10977388|NCT00944697|EG000|Reported Event|Placebo Tablets|A placebo tablet to match the active reference treatment
10977389|NCT00944697|EG001|Reported Event|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
10977390|NCT00944710|BG000|Baseline|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
10977391|NCT00944710|BG001|Baseline|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
10977392|NCT00944710|BG002|Baseline|Total|Total of all reporting groups
10977393|NCT00944710|FG000|Participant Flow|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
10977394|NCT00944710|FG001|Participant Flow|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
10977395|NCT00944710|OG000|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
10977396|NCT00944710|OG001|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
10977397|NCT00944710|EG000|Reported Event|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
10977398|NCT00944710|EG001|Reported Event|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
10977399|NCT00944749|BG000|Baseline|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects' refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
10977400|NCT00944749|FG000|Participant Flow|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects' refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
10977401|NCT00944749|OG000|Outcome|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects' refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
10872128|NCT00421993|EG002|Reported Event|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
10872129|NCT00421993|EG003|Reported Event|Gel Vehicle|Topical Gel Vehicle
10872130|NCT00422032|BG000|Baseline|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
10872131|NCT00422032|BG001|Baseline|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
10872132|NCT00422032|BG002|Baseline|Total|Total of all reporting groups
10872133|NCT00422032|FG000|Participant Flow|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
10872134|NCT00422032|FG001|Participant Flow|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
10872135|NCT00422032|OG000|Outcome|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
10872136|NCT00422032|OG001|Outcome|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
10872137|NCT00422032|EG000|Reported Event|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
10872138|NCT00422032|EG001|Reported Event|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
10872139|NCT00422058|BG000|Baseline|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872140|NCT00422058|BG001|Baseline|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872141|NCT00422058|BG002|Baseline|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872142|NCT00422058|BG003|Baseline|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872143|NCT00422058|BG004|Baseline|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872144|NCT00422058|BG005|Baseline|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
10872145|NCT00422058|BG006|Baseline|Total|Total of all reporting groups
10872146|NCT00422058|FG000|Participant Flow|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872147|NCT00422058|FG001|Participant Flow|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872148|NCT00422058|FG002|Participant Flow|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872149|NCT00422058|FG003|Participant Flow|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872150|NCT00422058|FG004|Participant Flow|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872151|NCT00422058|FG005|Participant Flow|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
10872152|NCT00422058|OG000|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872153|NCT00422058|OG001|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872154|NCT00422058|OG002|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872155|NCT00422058|OG003|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872156|NCT00422058|OG004|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10977402|NCT00944749|EG000|Reported Event|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects' refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
10977403|NCT00945061|BG000|Baseline|Intraoperative Radiation Therapy|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977404|NCT00945061|BG001|Baseline|Intracavitary Balloon Brachytherapy|Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
10977405|NCT00945061|BG002|Baseline|Total|Total of all reporting groups
10977406|NCT00945061|FG000|Participant Flow|Intraoperative Radiation Therapy|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977407|NCT00945061|FG001|Participant Flow|Intracavitary Balloon Brachytherapy|Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
10977408|NCT00945061|OG000|Outcome|Intraoperative Radiation Therapy|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977409|NCT00945061|OG001|Outcome|Intracavitary Balloon Brachytherapy|Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
10977410|NCT00945061|OG000|Outcome|Intraoperative Radiation Therapy|"Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.~Intraoperative radiation therapy: Patients undergo radiotherapy"
10977411|NCT00945061|OG001|Outcome|Intracavitary Balloon Brachytherapy|"Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.~intracavitary balloon brachytherapy: Patients undergo brachytherapy"
10977412|NCT00945061|OG000|Outcome|Baseline|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977413|NCT00945061|OG001|Outcome|1 Month|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977414|NCT00945061|OG002|Outcome|3 Months|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977415|NCT00945061|OG003|Outcome|6 Month|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977416|NCT00945061|OG004|Outcome|9 Months|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977417|NCT00945061|OG005|Outcome|12 Months|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977418|NCT00945061|OG006|Outcome|5 Years|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977419|NCT00945061|EG000|Reported Event|Intraoperative Radiation Therapy|Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
10977420|NCT00945061|EG001|Reported Event|Intracavitary Balloon Brachytherapy|Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
10977421|NCT00945100|BG000|Baseline|Control|2 hours daily patching
10977422|NCT00945100|BG001|Baseline|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
10977423|NCT00945100|BG002|Baseline|Total|Total of all reporting groups
10977424|NCT00945100|FG000|Participant Flow|Control|2 hours daily patching
10977425|NCT00945100|FG001|Participant Flow|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
10977426|NCT00945100|OG000|Outcome|Control|2 hours daily patching
10977427|NCT00945100|OG001|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
10977428|NCT00945100|EG000|Reported Event|Control|2 hours daily patching
10977429|NCT00945100|EG001|Reported Event|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
10977430|NCT00945139|BG000|Baseline|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
10977431|NCT00945139|FG000|Participant Flow|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
10977432|NCT00945139|OG000|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
10977433|NCT00945139|OG000|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
10977434|NCT00945139|EG000|Reported Event|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
10977435|NCT00945191|BG000|Baseline|CS-1008 in Combination With Paclitaxel/Carboplatin|Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
11336369|NCT03565315|EG000|Reported Event|Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group|"10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1."
10872157|NCT00422058|OG005|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
10872158|NCT00422058|EG000|Reported Event|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872159|NCT00422058|EG001|Reported Event|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872160|NCT00422058|EG002|Reported Event|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872161|NCT00422058|EG003|Reported Event|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872162|NCT00422058|EG004|Reported Event|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
10872163|NCT00422058|EG005|Reported Event|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
10872164|NCT00422084|BG000|Baseline|PA Group|"Pyronaridine artesunate (PA)~Pyronaridine artesunate: Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2)"
10872165|NCT00422084|BG001|Baseline|AL Group|"Arthemether lumefantrine (AL)~Coartem® (artemether lumefantrine): AL twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)"
10872166|NCT00422084|BG002|Baseline|Total|Total of all reporting groups
10872167|NCT00422084|FG000|Participant Flow|PA Group|"Pyronaridine artesunate (PA)~Pyronaridine artesunate: Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2)"
10872168|NCT00422084|FG001|Participant Flow|AL Group|"Arthemether lumefantrine (AL)~Coartem® (artemether lumefantrine): AL twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)"
10872169|NCT00422084|OG000|Outcome|PA Group|"Pyronaridine artesunate (PA)~Pyronaridine artesunate: Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2)"
10872170|NCT00422084|OG001|Outcome|AL Group|"Arthemether lumefantrine (AL)~Coartem® (artemether lumefantrine): AL twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)"
10872171|NCT00422084|EG000|Reported Event|PA Group|"Pyronaridine artesunate (PA)~Pyronaridine artesunate: Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2)"
10872172|NCT00422084|EG001|Reported Event|AL Group|"Arthemether lumefantrine (AL)~Coartem® (artemether lumefantrine): AL twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)"
10872173|NCT00422097|BG000|Baseline|Ixabepilone, 5 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 5 mg, on Days 1 through 5 every 21 days.
10872174|NCT00422097|BG001|Baseline|Ixabepilone, 10 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 10 mg, on Days 1 through 5 every 21 days.
10872175|NCT00422097|BG002|Baseline|Ixabepilone, 15 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 15 mg, on Days 1 through 5 every 21 days.
10872176|NCT00422097|BG003|Baseline|Ixabepilone, 20 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 20 mg, on Days 1 through 5 every 21 days.
10872177|NCT00422097|BG004|Baseline|Ixabepilone, 25 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 25 mg, on Days 1 through 5 every 21 days.
10872178|NCT00422097|BG005|Baseline|Ixabepilone, 30 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 30 mg, on Days 1 through 5 every 21 days.
10872179|NCT00422097|BG006|Baseline|Total|Total of all reporting groups
10872180|NCT00422097|FG000|Participant Flow|Ixabepilone, 5 mg/d|Ixabepilone, 5 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a dose-limiting toxicity (DLT) in the first 21-day course, a new cohort is opened at the next dose level (10 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
10872181|NCT00422097|FG001|Participant Flow|Ixabepilone, 10 mg/d|Ixabepilone, 10 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (15 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
10872182|NCT00422097|FG002|Participant Flow|Ixabepilone, 15 mg/d|Ixabepilone, 15 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (20 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
10872183|NCT00422097|FG003|Participant Flow|Ixabepilone, 20 mg/d|Ixabepilone, 20 mg, given daily in oral doses on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (25 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
10872184|NCT00422097|FG004|Participant Flow|Ixabepilone, 25 mg/d|Ixabepilone, 25 mg/d, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT in the first 21-day course, a new cohort is opened at the next dose level (30 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD. The MTD is the maximum dose that can be given to 6 participants without producing a DLT in more than 1 participant (or fewer than 1/3 if the cohort has more than 6 participants). More participants may be enrolled at any level to provide additional safety data. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
10872185|NCT00422097|FG005|Participant Flow|Ixabepilone, 30 mg/d|Ixabepilone, 30 mg, given daily orally on Days 1 through 5 every 21 days. If 2 or more of the first 3 participants experience a DLT within the first 21-day course, this dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD (the maximum dose that can be given to 6 participants without producing a DLT in more than 1 [or fewer than 1/3 if more than 6 participants in cohort)]. On all dosing days in Cycle 1, participants to fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
10872186|NCT00422097|FG006|Participant Flow|Ixabepilone, MTD (25 mg), With Famotidine|Cohort opened for Cycle 2, once ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, alone, orally once per day on Days 1 through 21. Then participants crossed over to receive famotidine wirh ixabepilone in Cycle 2. Prior to dosing on Day 1 of Cycle 2, famotidine, 40 mg, administered in an oral dose 2 hours before ixabepilone 25-mg dose.
10872187|NCT00422097|FG007|Participant Flow|Ixabepilone, MTD (25 mg), With Food|Cohort opened for Cycle 2, after ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, once daily in an oral dose on Days 1 through 5. On all dosing days in Cycle 1, participants fasted at least 4 hours before and 4 hours after dosing. Then participants crossed over to Cycle 2. On Day 1 of Cycle 2, participants allowed a low-fat meal. Participants ingest the specified meal within a 30-minute period and receive ixabepilone, 25 mg, 30 minutes after start of the meal. For the duration of Cycle 2, participants fast 1 hour before and 2 hours after ixabepilone dose.
10872188|NCT00422097|OG000|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
10872189|NCT00422097|OG001|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
10872190|NCT00422097|OG002|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
10872191|NCT00422097|OG003|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
10872192|NCT00422097|OG004|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
10872193|NCT00422097|OG005|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
10872194|NCT00422097|OG000|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
10872195|NCT00422097|OG000|Outcome|Ixabepilone, 5 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
10872196|NCT00422097|OG001|Outcome|Ixabepilone, 10 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
10872197|NCT00422097|OG002|Outcome|Ixabepilone, 15 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
10872198|NCT00422097|OG003|Outcome|Ixabepilone, 20 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
10872199|NCT00422097|OG004|Outcome|Ixabepilone, 25 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
10872200|NCT00422097|OG005|Outcome|Ixabepilone, 30 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
10872201|NCT00422097|OG000|Outcome|Ixabepilone, 25 mg/d|
10872202|NCT00422097|OG000|Outcome|Ixabepilone, 25 mg/d|Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone (with famotidine (Cycle 2). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after ixabepilone treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
10872203|NCT00422097|OG000|Outcome|Ixabepilone, 25 mg/d|Participants who received MTD (25 mg) ixabepilone without famotidine and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine. Fasted/Fed criteria: Cycle 1: Dose 1 administered after a minimum of a 4-hour fast. Cycle 2: Dose 1 administered with a low-fat meal to crossover cohort.
10872204|NCT00422097|EG000|Reported Event|Ixabepilone, 5 mg|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days
10872205|NCT00422097|EG001|Reported Event|Ixabepilone, 10 mg|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days
10872206|NCT00422097|EG002|Reported Event|Ixabepilone, 15 mg|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days
10872207|NCT00422097|EG003|Reported Event|Ixabepilone, 20 mg|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days
10872208|NCT00422097|EG004|Reported Event|Ixabepilone, 25 mg|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days
10872209|NCT00422097|EG005|Reported Event|Ixabepilone, 30 mg|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days
10872210|NCT00422162|BG000|Baseline|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
10872211|NCT00422162|BG001|Baseline|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
10872212|NCT00422162|BG002|Baseline|Total|Total of all reporting groups
10872213|NCT00422162|FG000|Participant Flow|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
10872214|NCT00422162|FG001|Participant Flow|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
10872215|NCT00422162|OG000|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
10872216|NCT00422162|OG001|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
10872217|NCT00422162|OG000|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
10872218|NCT00422162|OG001|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
10872219|NCT00422162|OG002|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
10872220|NCT00422162|OG003|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
10872221|NCT00422162|OG004|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
10872222|NCT00422162|OG005|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
10872223|NCT00422162|OG000|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
10872224|NCT00422162|OG001|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
10872225|NCT00422162|OG002|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
10872226|NCT00422162|OG003|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
10872227|NCT00422162|EG000|Reported Event|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
10872228|NCT00422162|EG001|Reported Event|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
10872229|NCT00422201|BG000|Baseline|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
10872230|NCT00422201|FG000|Participant Flow|Single Arm Mifepristone|"Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
10872231|NCT00422201|OG000|Outcome|Mifepristone|"Single arm. Study medication was administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
10872232|NCT00422201|OG000|Outcome|Prospective, Open-label, Study of Mifepristone|"Eligible subjects will start study treatment at the dose of 600 mg/day (given as one 200 mg tablet tid, per os). Total duration of treatment will not exceed 12 months. At the end of 12-month treatment, investigators may petition to extend treatment on a case-by-case basis.~Mifepristone: Singe dose"
10872233|NCT00422201|EG000|Reported Event|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
10872234|NCT00422227|BG000|Baseline|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
10872235|NCT00422227|BG001|Baseline|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
10872236|NCT00422227|BG002|Baseline|Total|Total of all reporting groups
10872237|NCT00422227|FG000|Participant Flow|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
10872238|NCT00422227|FG001|Participant Flow|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
10872239|NCT00422227|OG000|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
10872240|NCT00422227|OG001|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
10872241|NCT00422227|EG000|Reported Event|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
10872242|NCT00422227|EG001|Reported Event|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
10872243|NCT00422279|BG000|Baseline|Supralveolar Position|bone inductive implants placed in supraalveolar position
10872244|NCT00422279|BG001|Baseline|Extraction Sites|bone inductive implants placed in tooth extraction sites
10872245|NCT00422279|BG002|Baseline|Total|Total of all reporting groups
10872246|NCT00422279|FG000|Participant Flow|Supraalveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
10872247|NCT00422279|FG001|Participant Flow|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
10872248|NCT00422279|OG000|Outcome|Supra Aleveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
10872249|NCT00422279|OG001|Outcome|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
10872250|NCT00422279|OG000|Outcome|Supraalveloar Postion|bone inductive implants placed in supraalveolar position a total of 2 patients with 4 implants ( two implants in each patient)
10872251|NCT00422279|OG001|Outcome|Extraction Sites|bone inductive implants placed in tooth extraction sockets with a total of 2 patients with 4 implants ( two implants in each patient)
10872252|NCT00422279|EG000|Reported Event|Supralveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
10872253|NCT00422279|EG001|Reported Event|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sites
10872254|NCT00422292|BG000|Baseline|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
10872255|NCT00422292|BG001|Baseline|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
10872256|NCT00422292|BG002|Baseline|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
10872257|NCT00422292|BG003|Baseline|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
10872258|NCT00422292|BG004|Baseline|Total|Total of all reporting groups
10872259|NCT00422292|FG000|Participant Flow|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
10872260|NCT00422292|FG001|Participant Flow|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
10872261|NCT00422292|FG002|Participant Flow|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
10872262|NCT00422292|FG003|Participant Flow|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
10872263|NCT00422292|OG000|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
10872264|NCT00422292|OG001|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
10872265|NCT00422292|OG002|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
10872266|NCT00422292|OG003|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
10872267|NCT00422292|EG000|Reported Event|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
10872268|NCT00422292|EG001|Reported Event|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
10977436|NCT00945191|FG000|Participant Flow|CS-1008 in Combination With Paclitaxel/Carboplatin|Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
10977437|NCT00945191|OG000|Outcome|CS-1008 in Combination With Paclitaxel/Carboplatin|Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
10977438|NCT00945191|EG000|Reported Event|CS-1008 in Combination With Paclitaxel/Carboplatin|Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
10977439|NCT00945243|BG000|Baseline|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
10977440|NCT00945243|FG000|Participant Flow|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
10977441|NCT00945243|OG000|Outcome|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
10977442|NCT00945243|EG000|Reported Event|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
10977443|NCT00945256|BG000|Baseline|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
10977444|NCT00945256|BG001|Baseline|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
10977445|NCT00945256|BG002|Baseline|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
10977446|NCT00945256|BG003|Baseline|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
10977447|NCT00945256|BG004|Baseline|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
10977448|NCT00945256|BG005|Baseline|Total|Total of all reporting groups
10977449|NCT00945256|FG000|Participant Flow|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak
10977450|NCT00945256|FG001|Participant Flow|Elderly Aerobic Exercise|45 minutes of treadmill walking at 40% VO2 peak.
10977451|NCT00945256|FG002|Participant Flow|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
10977452|NCT00945256|FG003|Participant Flow|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
10977453|NCT00945256|FG004|Participant Flow|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
10977454|NCT00945256|OG000|Outcome|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
10977455|NCT00945256|OG001|Outcome|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
10977456|NCT00945256|OG002|Outcome|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
10977457|NCT00945256|OG003|Outcome|Elderly Sodium Nitroprusside (SNP)|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
10977458|NCT00945256|OG004|Outcome|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and a 7.5g amino acid drink taken orally.
10977459|NCT00945256|EG000|Reported Event|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
10977460|NCT00945256|EG001|Reported Event|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
10977461|NCT00945256|EG002|Reported Event|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
10977462|NCT00945256|EG003|Reported Event|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
10977463|NCT00945256|EG004|Reported Event|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 grams of amino acids taken orally.
10977464|NCT00945282|BG000|Baseline|GSK2248761 30 mg|Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days
10977465|NCT00945282|BG001|Baseline|Placebo|Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days
10977466|NCT00945282|BG002|Baseline|Total|Total of all reporting groups
10977467|NCT00945282|FG000|Participant Flow|GSK2248761 30 mg|Eligible participants received 3 capsules of GSK2248761 10 milligrams (mg) orally once daily dosed with 360 milliliter (mL) water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or Highly active antiretroviral therapy (HAART) for 28 days.
10977468|NCT00945282|FG001|Participant Flow|Placebo|Eligible participants received matching placebo capsules to GSK2248761 10 mg capsules, orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days.
10977469|NCT00945282|OG000|Outcome|GSK2248761 30 mg|Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days.
10977470|NCT00945282|OG001|Outcome|Placebo|Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days.
10977471|NCT00945282|OG000|Outcome|GSK2248761 30 mg|Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days.
10977472|NCT00945282|OG000|Outcome|GSK2248761 30 mg|Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days
10977473|NCT00945282|OG001|Outcome|Placebo|Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days
10977474|NCT00945282|OG000|Outcome|GSK2248761 30 mg|The eligible participants in this arm received GSK2248761 as 30 mg once daily for up to 7-days daily. On Day 8 participants received either Kaletra or HAART for 28 days.
10977475|NCT00945282|OG001|Outcome|IDX899 100 mg|The eligible participants in this arm received IDX899 100 mg, once daily orally for upto 7-days daily. The dose was accompanied with 360 mL of water. On Day 8 participants received either Kaletra or HAART for 28 days. Data was taken from the Idenix NV-05A-002 study.
10977476|NCT00945282|OG002|Outcome|IDX899 200 mg|The eligible participants in this arm received IDX899 200 mg, once daily orally for upto 7-days daily. The dose was accompanied with 360 mL of water . On Day 8 participants received either Kaletra or HAART for 28 days. Data was taken from the Idenix NV-05A-002 study.
10977477|NCT00945282|OG003|Outcome|IDX899 400 mg|The eligible participants in this arm received IDX899 400 mg, once daily orally for upto 7-days daily. The dose was accompanied with 360 mL of water. On Day 8 participants received either Kaletra or HAART for 28 days. Data was taken from the Idenix NV-05A-002 study.
10977478|NCT00945282|OG004|Outcome|IDX899 800 mg|The eligible participants in this arm received IDX899 800 mg, once daily orally for upto 7-days daily. The dose was accompanied with 360 mL of water. On Day 8 participants received either Kaletra or HAART for 28 days. Data was taken from the Idenix NV-05A-002 study.
10977479|NCT00945282|EG000|Reported Event|GSK2248761 30 mg|The eligible participants in this arm received GSK2248761 as 30 mg once daily for up to 7-days daily . On Day 8 participants received either Kaletra or HAART for 28 days.
10977480|NCT00945282|EG001|Reported Event|Placebo|The eligible participants in this arm received matching placebo once daily for 7-days. On Day 8 participants received either Kaletra or HAART for 28 days
10977481|NCT00945295|BG000|Baseline|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
10872269|NCT00422292|EG002|Reported Event|Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
10872270|NCT00422292|EG003|Reported Event|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
10872271|NCT00422383|BG000|Baseline|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872272|NCT00422383|BG001|Baseline|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872273|NCT00422383|BG002|Baseline|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872274|NCT00422383|BG003|Baseline|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872275|NCT00422383|BG004|Baseline|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872276|NCT00422383|BG005|Baseline|Total|Total of all reporting groups
10872277|NCT00422383|FG000|Participant Flow|Rituximab Low Dose Plus (+) Methotrexate|Participants received rituximab, 0.5 grams (g), intravenously (IV), on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 milligrams (mg), IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 milligrams per milliliter (mg/mL), orally (PO) or parenterally, as prescribed. Participants also received a stable dose of folate greater than or equal to (≥) 5 milligrams per week (mg/week) given either as a single dose or as a divided weekly dose.
10872278|NCT00422383|FG001|Participant Flow|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872279|NCT00422383|FG002|Participant Flow|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872280|NCT00422383|FG003|Participant Flow|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10977482|NCT00945295|BG001|Baseline|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
10977483|NCT00945295|BG002|Baseline|Total|Total of all reporting groups
10977484|NCT00945295|FG000|Participant Flow|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
10977485|NCT00945295|FG001|Participant Flow|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
10977486|NCT00945295|OG000|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
10977487|NCT00945295|OG001|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
10977488|NCT00945295|EG000|Reported Event|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
10977489|NCT00945295|EG001|Reported Event|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
10977490|NCT00945321|BG000|Baseline|All Participants|All randomized patients.
10977491|NCT00945321|FG000|Participant Flow|A/B/C/D|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
10977492|NCT00945321|FG001|Participant Flow|B/C/A/D|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
10977493|NCT00945321|FG002|Participant Flow|C/A/B/D|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
10977494|NCT00945321|FG003|Participant Flow|A/C/B/E|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
10977495|NCT00945321|FG004|Participant Flow|B/A/C/E|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
10977496|NCT00945321|FG005|Participant Flow|C/B/A/E|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
10977497|NCT00945321|OG000|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
10977498|NCT00945321|OG001|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
10977499|NCT00945321|OG002|Outcome|150 mg Fosaprepitant Dimeglumine (Fasted State)|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
10977500|NCT00945321|OG003|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
10977501|NCT00945321|OG004|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
10977502|NCT00945321|OG005|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
10977503|NCT00945321|OG006|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
10977504|NCT00945321|OG002|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
10977505|NCT00945321|OG003|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
10977506|NCT00945321|OG004|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
10977507|NCT00945321|OG005|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
10977508|NCT00945321|EG000|Reported Event|165 mg Aprepitant|165 mg aprepitant Final Market Composition capsule in the fasted state
10977509|NCT00945321|EG001|Reported Event|185 mg Aprepitant|185 mg aprepitant Final Market Composition capsule in the fasted state
10977510|NCT00945321|EG002|Reported Event|150 mg Fosaprepitant Dimeglumine|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
10977511|NCT00945321|EG003|Reported Event|165 mg Aprepitant (Fed State)|"165 mg aprepitant Final Market Composition capsule in the fed~state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the~subjects (9) in this treatment group received a standard light breakfast)"
10977512|NCT00945321|EG004|Reported Event|185 mg Aprepitant (Fed State)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
10977513|NCT00945334|BG000|Baseline|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
10977514|NCT00945334|BG001|Baseline|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
10977515|NCT00945334|BG002|Baseline|Total|Total of all reporting groups
10977516|NCT00945334|FG000|Participant Flow|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
10977517|NCT00945334|FG001|Participant Flow|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
10977518|NCT00945334|OG000|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
10977519|NCT00945334|OG001|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
10977520|NCT00945334|EG000|Reported Event|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
10977521|NCT00945334|EG001|Reported Event|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
10977522|NCT00945477|BG000|Baseline|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib~Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
10977523|NCT00945477|FG000|Participant Flow|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib~Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
10977524|NCT00945477|OG000|Outcome|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
10977525|NCT00945477|OG000|Outcome|Participants With Adverse Events 800mg Pazopanib|Adverse events for all participants, all grades
10977526|NCT00945477|EG000|Reported Event|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
10977527|NCT00945555|BG000|Baseline|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
10977528|NCT00945555|FG000|Participant Flow|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
10977529|NCT00945555|OG000|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
10977530|NCT00945555|EG000|Reported Event|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
10977531|NCT00945594|BG000|Baseline|Flexible Cystoscopy|"16F flexible cysto urethroscope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977532|NCT00945594|BG001|Baseline|Rigid Cystoscopy|"17F, 70° scope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977533|NCT00945594|BG002|Baseline|Total|Total of all reporting groups
10977534|NCT00945594|FG000|Participant Flow|Flexible Cystoscopy|"16F flexible cysto urethroscope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977535|NCT00945594|FG001|Participant Flow|Rigid Cystoscopy|"17F, 70° scope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977536|NCT00945594|OG000|Outcome|Rigid Cystoscopy|"17F, 70° scope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977537|NCT00945594|OG001|Outcome|Flexible Cystoscopy|"16F flexible cysto urethroscope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977538|NCT00945594|OG000|Outcome|Flexible Cystoscopy|"16F flexible cysto urethroscope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977539|NCT00945594|OG001|Outcome|Rigid Cystoscopy|"17F, 70° scope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977540|NCT00945594|EG000|Reported Event|Flexible Cystoscopy|"16F flexible cysto urethroscope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977541|NCT00945594|EG001|Reported Event|Rigid Cystoscopy|"17F, 70° scope (Storz, Culver city, CA)~Cystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)"
10977542|NCT00945659|BG000|Baseline|Standard Care|"Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a basal-bolus approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.~Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses."
10977543|NCT00945659|BG001|Baseline|Continuous Glucose Sensor|"Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.~Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management."
10977544|NCT00945659|BG002|Baseline|CGS + Behavior Therapy|"Patients in this group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.~CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care."
10977545|NCT00945659|BG003|Baseline|Total|Total of all reporting groups
10977546|NCT00945659|FG000|Participant Flow|Standard Care|"Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a basal-bolus approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.~Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses."
10977547|NCT00945659|FG001|Participant Flow|Continuous Glucose Sensor|"Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.~Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management."
10977548|NCT00945659|FG002|Participant Flow|CGS + Behavior Therapy|"Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.~CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care."
10977549|NCT00945659|OG000|Outcome|Standard Care|"Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a basal-bolus approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.~Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses."
10977550|NCT00945659|OG001|Outcome|Continuous Glucose Sensor|"Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.~Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management."
10977551|NCT00945659|OG002|Outcome|CGS + Behavior Therapy|"Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.~CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care."
10977552|NCT00945659|EG000|Reported Event|Standard Care|"Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a basal-bolus approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.~Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses."
10977553|NCT00945659|EG001|Reported Event|Continuous Glucose Sensor|"Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.~Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management."
10977554|NCT00945659|EG002|Reported Event|CGS + Behavior Therapy|"Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.~CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care."
10977555|NCT00945750|BG000|Baseline|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
10977556|NCT00945750|BG001|Baseline|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
10977557|NCT00945750|BG002|Baseline|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
10977558|NCT00945750|BG003|Baseline|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
10977559|NCT00945750|BG004|Baseline|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
10977560|NCT00945750|BG005|Baseline|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
10977561|NCT00945750|BG006|Baseline|Total|Total of all reporting groups
10977562|NCT00945750|FG000|Participant Flow|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
10977563|NCT00945750|FG001|Participant Flow|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
10977564|NCT00945750|FG002|Participant Flow|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
10977565|NCT00945750|FG003|Participant Flow|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
10977566|NCT00945750|FG004|Participant Flow|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
10977567|NCT00945750|FG005|Participant Flow|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
10977568|NCT00945750|OG000|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
10977569|NCT00945750|OG001|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
10977570|NCT00945750|OG000|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
10977571|NCT00945750|EG000|Reported Event|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT (film-coated tablet) with 120 mL of water
10977572|NCT00945750|EG001|Reported Event|Famotidine 20 mg CT Without Water|Famotidine 20 mg Chewable Tablet without water
10977573|NCT00945750|EG002|Reported Event|Famotidine 20 mg CT With Water|Famotidine 20 mg chewable tablet with 120 mL of water
10977574|NCT00945815|BG000|Baseline|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
10977575|NCT00945815|FG000|Participant Flow|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
10977576|NCT00945815|OG000|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
10977577|NCT00945815|EG000|Reported Event|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
10977578|NCT00945854|BG000|Baseline|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
10977579|NCT00945854|BG001|Baseline|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
10977580|NCT00945854|BG002|Baseline|Total|Total of all reporting groups
10977581|NCT00945854|FG000|Participant Flow|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
10977582|NCT00945854|FG001|Participant Flow|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
10977583|NCT00945854|OG000|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
10977584|NCT00945854|OG001|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
10977585|NCT00945854|EG000|Reported Event|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
10977586|NCT00945854|EG001|Reported Event|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
10977587|NCT00945893|BG000|Baseline|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977588|NCT00945893|BG001|Baseline|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
10977589|NCT00945893|BG002|Baseline|Total|Total of all reporting groups
10977590|NCT00945893|FG000|Participant Flow|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.
10977591|NCT00945893|FG001|Participant Flow|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
10977592|NCT00945893|OG000|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977593|NCT00945893|OG001|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
10977594|NCT00945893|EG000|Reported Event|H1N1 Monovalent Vaccine Days 1-15|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977595|NCT00945893|EG001|Reported Event|Placebo Days 1-15|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977596|NCT00945893|EG002|Reported Event|H1N1 Monovalent Vaccine Days 29-57|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977597|NCT00945893|EG003|Reported Event|Placebo Days 29-57|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977598|NCT00945893|EG004|Reported Event|H1N1 Monovalent Days 58-209|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977599|NCT00945893|EG005|Reported Event|Placebo Days 58-209|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977600|NCT00945906|BG000|Baseline|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
10977601|NCT00945906|FG000|Participant Flow|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
10977602|NCT00945906|OG000|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
10977603|NCT00945906|EG000|Reported Event|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
10977604|NCT00945945|BG000|Baseline|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
11007036|NCT01089127|FG000|Participant Flow|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
10872281|NCT00422383|FG004|Participant Flow|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872282|NCT00422383|OG000|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872283|NCT00422383|OG001|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872284|NCT00422383|OG002|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872285|NCT00422383|OG003|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872286|NCT00422383|OG004|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872287|NCT00422383|OG001|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872288|NCT00422383|OG000|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872289|NCT00422383|OG001|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872290|NCT00422383|OG002|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872291|NCT00422383|OG003|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872292|NCT00422383|OG004|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872293|NCT00422383|EG000|Reported Event|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872294|NCT00422383|EG001|Reported Event|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872295|NCT00422383|EG002|Reported Event|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
10872296|NCT00422383|EG003|Reported Event|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872297|NCT00422383|EG004|Reported Event|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
10872298|NCT00422422|BG000|Baseline|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
10872299|NCT00422422|FG000|Participant Flow|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
10872300|NCT00422422|OG000|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
10872301|NCT00422422|OG000|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
10872302|NCT00422422|OG000|Outcome|Brivaracetam (FAS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
10879279|NCT00456599|OG000|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
10977605|NCT00945945|BG001|Baseline|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
10977606|NCT00945945|BG002|Baseline|Total|Total of all reporting groups
10977607|NCT00945945|FG000|Participant Flow|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
10977608|NCT00945945|FG001|Participant Flow|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
10977609|NCT00945945|OG000|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
10977610|NCT00945945|OG001|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
10977611|NCT00945945|EG000|Reported Event|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
10977612|NCT00945945|EG001|Reported Event|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
10977613|NCT00945958|BG000|Baseline|SPARC0913|Inhaled dose of SPARC0913. Each single dose was administered as 1, 2, 4 and 8 puffs from the inhaler.
10977614|NCT00945958|FG000|Participant Flow|SPARC0913|
10977615|NCT00945958|OG000|Outcome|SPARC|The number and percentage of subjects reporting a TEAE were tabulated by system organ classification and preferred terms.
10977616|NCT00945958|OG000|Outcome|SPARC0913|SPARC0913: One drop of SPARC0913 in affected eye once daily for 24 weeks
10977617|NCT00945958|EG000|Reported Event|SPARC0913|From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated
10977618|NCT00946023|BG000|Baseline|Transplant|"Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.~Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily~Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily~Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction~Tacrolimus: Start on Day 5 through Day 180~Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)~Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m^2 IV"
11098954|NCT01579045|EG001|Reported Event|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
10977619|NCT00946023|FG000|Participant Flow|Transplant|"Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.~Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily~Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily~Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction~Tacrolimus: Start on Day 5 through Day 180~Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)~Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m^2 IV"
10977620|NCT00946023|OG000|Outcome|Transplant|"Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.~Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily~Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily~Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction~Tacrolimus: Start on Day 5 through Day 180~Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)~Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m^2 IV"
10977621|NCT00946023|EG000|Reported Event|Transplant|"Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.~Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily~Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily~Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction~Tacrolimus: Start on Day 5 through Day 180~Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)~Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m^2 IV"
11007037|NCT01089127|FG001|Participant Flow|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007038|NCT01089127|FG002|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007039|NCT01089127|FG003|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007040|NCT01089127|FG004|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007041|NCT01089127|FG005|Participant Flow|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007042|NCT01089127|OG000|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007043|NCT01089127|OG001|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007044|NCT01089127|OG002|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007045|NCT01089127|OG003|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
10977622|NCT00946088|BG000|Baseline|Progesterone|Progesterone 400 mg per vagina qhs.
10977623|NCT00946088|BG001|Baseline|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
10977624|NCT00946088|BG002|Baseline|Total|Total of all reporting groups
10977625|NCT00946088|FG000|Participant Flow|Progesterone|Progesterone 400 mg per vagina qhs.
10977626|NCT00946088|FG001|Participant Flow|Polyethylene Glycol 400 Distearate & Hydrogenated Vegetable oi|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
10977627|NCT00946088|OG000|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
10977628|NCT00946088|OG001|Outcome|Polyethylene Glycol&Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
10977629|NCT00946088|OG001|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
10977630|NCT00946088|OG001|Outcome|Polyethylene & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
10977631|NCT00946088|EG000|Reported Event|Active Comparator: Progesterone|Progesterone 400mg per vagina qhs.
10977632|NCT00946088|EG001|Reported Event|Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab|Placebo Comparator:Polyethylene glycol&hydrogenated vegetable oil per vagina.
10977633|NCT00946101|BG000|Baseline|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977634|NCT00946101|BG001|Baseline|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977635|NCT00946101|BG002|Baseline|Total|Total of all reporting groups
10977636|NCT00946101|FG000|Participant Flow|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977637|NCT00946101|FG001|Participant Flow|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977638|NCT00946101|OG000|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977639|NCT00946101|OG001|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
10977640|NCT00946101|EG000|Reported Event|H1N1 Monovalent Vaccine Days 1-28|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
10977641|NCT00946101|EG001|Reported Event|Placebo Days 1-28|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
10977642|NCT00946101|EG002|Reported Event|H1N1 Monvalent Vaccine Days 29-57|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
10977643|NCT00946101|EG003|Reported Event|Placebo Days 29-57|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
10977644|NCT00946101|EG004|Reported Event|H1N1 Monovalent Vaccine Days 58-209|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
10977645|NCT00946101|EG005|Reported Event|Placebo Days 58-209|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
10977646|NCT00946114|BG000|Baseline|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
10977647|NCT00946114|BG001|Baseline|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
10977648|NCT00946114|BG002|Baseline|Total|Total of all reporting groups
10977649|NCT00946114|FG000|Participant Flow|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
10977650|NCT00946114|FG001|Participant Flow|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
10977651|NCT00946114|OG000|Outcome|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
10977652|NCT00946114|OG001|Outcome|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
10977653|NCT00946114|EG000|Reported Event|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
10977654|NCT00946114|EG001|Reported Event|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
10977655|NCT00946153|BG000|Baseline|Phase 1: Group 1: Lenvatinib: 12 mg|Participants with CP scores of 5 or 6 received a starting dose of 12 mg (three 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating until the tolerated dose was achieved.
10977656|NCT00946153|BG001|Baseline|Phase 1: Group 1: Lenvatinib: 16 mg|Participants with CP scores of 5 or 6 received 16 mg (four 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating.
10977657|NCT00946153|BG002|Baseline|Phase 1: Group 2: Lenvatinib: 8 mg|Participants with CP scores of 7 or 8 received 8 mg (two 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle which was the lowest dose at which tolerability was confirmed in group 1, was used as the starting dose in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977658|NCT00946153|BG003|Baseline|Phase 1: Group 2: Lenvatinib: 12 mg|Participants with CP scores of 7 or 8 received 12 mg (three 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977659|NCT00946153|BG004|Baseline|Phase 2: Lenvatinib: 12 mg|Participants with CP scores of 5 or 6 received RD of 12 mg (three 4 mg tablets) lenvatinib established from group 1, in the dose escalation component (phase 1) study, orally QD in a 28-day treatment cycle in dose expansion component on an empty stomach or at least 1 hour after eating.
10977660|NCT00946153|BG005|Baseline|Total|Total of all reporting groups
10977661|NCT00946153|FG000|Participant Flow|Phase 1: Group 1: Lenvatinib: 12 mg|Participants with child-pugh (CP) scores of 5 or 6 received a starting dose of 12 milligram (mg) (three 4 mg tablets) lenvatinib orally once daily (QD) in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating until the tolerated dose was achieved.
10977662|NCT00946153|FG001|Participant Flow|Phase 1: Group 1: Lenvatinib: 16 mg|Participants with CP scores of 5 or 6 received 16 mg (four 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating.
10977663|NCT00946153|FG002|Participant Flow|Phase 1: Group 2: Lenvatinib: 8 mg|Participants with CP scores of 7 or 8 received 8 mg (two 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle which was the lowest dose at which tolerability was confirmed in group 1, was used as the starting dose in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977664|NCT00946153|FG003|Participant Flow|Phase 1: Group 2: Lenvatinib: 12 mg|Participants with CP scores of 7 or 8 received 12 mg (three 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977665|NCT00946153|FG004|Participant Flow|Phase 2: Lenvatinib: 12 mg|Participants with CP scores of 5 or 6 received recommended dose (RD) of 12 mg (three 4 mg tablets) lenvatinib established from group 1, in the dose escalation component (phase 1) study, orally QD in a 28-day treatment cycle in dose expansion component on an empty stomach or at least 1 hour after eating.
10977666|NCT00946153|OG000|Outcome|Phase 1: Group 1: Levatinib 12 or 16 mg (CP Score 5 or 6)|Participants with CP scores of 5 or 6 received 12 mg (three 4 mg tablets) or 16 mg (four 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating.
10977667|NCT00946153|OG001|Outcome|Phase 1: Group 2: Lenvatinib 8 or 12 mg (CP Score 7 or 8)|Participants with CP scores of 7 or 8 received 8 mg (two 4 mg tablets) or 12 mg (three 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977668|NCT00946153|OG000|Outcome|Phase 2 : Lenvatinib :12 mg|Participants with CP scores of 5 or 6 received lenvatinib RD of 12 mg (three 4 mg tablets) established from group 1 in the dose escalation component (Phase 1) study, orally QD in a 28-day treatment cycle in dose expansion component on an empty stomach or at least 1 hour after eating.
10977669|NCT00946153|OG000|Outcome|Phase 1: Group 1: Lenvatinib: 12 mg|Participants with CP scores of 5 or 6 received a starting dose of 12 mg (three 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating until the tolerated dose was achieved.
10977670|NCT00946153|OG001|Outcome|Phase 1: Group1: Lenvatinib: 16 mg|Participants with CP scores of 5 or 6 received 16 mg (four 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating.
10977671|NCT00946153|OG002|Outcome|Phase 1: Group 2: Lenvatinib: 8 mg|Participants with CP scores of 7 or 8 received 8 mg (two 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle which was the lowest dose at which tolerability was confirmed in group1, was used as the starting dose in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977672|NCT00946153|OG003|Outcome|Phase 1: Group 2: Lenvatinib: 12 mg|Participants with CP scores of 7 or 8 received 12 mg (three 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977673|NCT00946153|OG002|Outcome|Phase 1: Group 2: Lenvatinib: 8 mg|Participants with CP scores of 7 or 8 received 8 mg (two 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle which was the lowest dose at which tolerability was confirmed in group 1, was used as the starting dose in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977674|NCT00946153|OG000|Outcome|Phase 2 : Lenvatinib :12 mg|Participants with CP scores of 5 or 6 received RD of 12 mg (three 4 mg tablets) lenvatinib established from group 1 in the dose escalation component (phase 1) study, orally QD in a 28-day treatment cycle in dose expansion component on an empty stomach or at least 1 hour after eating.
10977675|NCT00946153|OG000|Outcome|Phase 2 : Lenvatinib :12 mg|Participants with CP scores of 5 or 6 received RD of 12 mg (three 4 mg tablets) lenvatinib established from group 1 in the dose escalation component (Phase 1) study, orally QD in a 28-day treatment cycle in dose expansion component on an empty stomach or at least 1 hour after eating.
10977676|NCT00946153|EG000|Reported Event|Phase 1: Group 1: Lenvatinib: 12 mg|Participants with child CP scores of 5 or 6 received a starting dose of 12 mg (three 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating until the tolerated dose was achieved.
10977677|NCT00946153|EG001|Reported Event|Phase 1: Group 1: Lenvatinib: 16 mg|Participants with CP scores of 5 or 6 received 16 mg (four 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-escalation scheme (group 1) on an empty stomach or at least 1 hour after eating.
10977678|NCT00946153|EG002|Reported Event|Phase 1: Group 2: Lenvatinib: 8 mg|Participants with CP scores of 7 or 8 received 8 mg (two 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle which was the lowest dose at which tolerability was confirmed in group 1, was used as the starting dose in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10872303|NCT00422422|EG000|Reported Event|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
10872304|NCT00422448|BG000|Baseline|Nevi|with or without BRAF and NRAS
10872305|NCT00422448|FG000|Participant Flow|Nevi|with or without BRAF and NRAS
10872306|NCT00422448|OG000|Outcome|Nevi|with or without BRAF and NRAS
10872307|NCT00422448|EG000|Reported Event|Nevi|with or without BRAF and NRAS
10872308|NCT00422461|BG000|Baseline|Placebo|Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872309|NCT00422461|BG001|Baseline|PF-00489791 4 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872310|NCT00422461|BG002|Baseline|PF-00489791 10 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872311|NCT00422461|BG003|Baseline|PF-00489791 20/40 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.
10872312|NCT00422461|BG004|Baseline|Total|Total of all reporting groups
10872313|NCT00422461|FG000|Participant Flow|Placebo|Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872314|NCT00422461|FG001|Participant Flow|PF-00489791 4 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 milligram (mg) (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872315|NCT00422461|FG002|Participant Flow|PF-00489791 10 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872316|NCT00422461|FG003|Participant Flow|PF-00489791 20/40 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.
10872317|NCT00422461|OG000|Outcome|Placebo|Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872318|NCT00422461|OG001|Outcome|PF-00489791 4 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872319|NCT00422461|OG002|Outcome|PF-00489791 10 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872320|NCT00422461|OG003|Outcome|PF-00489791 20/40 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.
10872321|NCT00422461|EG000|Reported Event|Placebo|Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872322|NCT00422461|EG001|Reported Event|PF-00489791 4 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872323|NCT00422461|EG002|Reported Event|PF-00489791 10 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
10872324|NCT00422461|EG003|Reported Event|PF-00489791 20/40 mg|Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.
10872325|NCT00422513|BG000|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
10872326|NCT00422513|BG001|Baseline|Epoetin Alfa|As prescribed, (iv), 3 times weekly
10872327|NCT00422513|BG002|Baseline|Total|Total of all reporting groups
10872328|NCT00422513|FG000|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms intravenous (iv) monthly, starting dose
10872329|NCT00422513|FG001|Participant Flow|Epoetin Alfa|As prescribed, (iv), 3 times weekly
10872330|NCT00422513|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
10872331|NCT00422513|OG001|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
10872332|NCT00422513|EG000|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
10872333|NCT00422513|EG001|Reported Event|Epoetin Alfa|As prescribed, (iv), 3 times weekly
10872334|NCT00422591|BG000|Baseline|Idarubicin + Cytarabine|Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
10872335|NCT00422591|FG000|Participant Flow|Idarubicin + Cytarabine|Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
10872336|NCT00422591|OG000|Outcome|Idarubicin + Cytarabine|Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
10872337|NCT00422591|EG000|Reported Event|Idarubicin + Cytarabine|Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
10872338|NCT00422656|BG000|Baseline|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
10872339|NCT00422656|FG000|Participant Flow|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
10872340|NCT00422656|OG000|Outcome|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
10872341|NCT00422656|EG000|Reported Event|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
10872342|NCT00422695|BG000|Baseline|HIV +|Groups divided according to CD4 counts
10872343|NCT00422695|BG001|Baseline|Healthy Controls|HIV -ve subjects
10872344|NCT00422695|BG002|Baseline|Total|Total of all reporting groups
10872345|NCT00422695|FG000|Participant Flow|HIV +|Groups divided according to CD4 counts 105 HIV subjects
10872346|NCT00422695|FG001|Participant Flow|Healthy Controls|HIV -free subjects 38 Healthy Controls
10872347|NCT00422695|OG000|Outcome|HIV +|Groups divided according to CD4 counts 105 HIV subjects
10872348|NCT00422695|OG001|Outcome|Healthy Controls|HIV -free subjects 38 Healthy Controls
10872349|NCT00422695|EG000|Reported Event|HIV +|Groups divided according to CD4 counts 105 HIV subjects
10872350|NCT00422695|EG001|Reported Event|Healthy Controls|HIV -free subjects 38 Healthy Controls
10872351|NCT00422734|BG000|Baseline|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
10872352|NCT00422734|BG001|Baseline|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
10872353|NCT00422734|BG002|Baseline|Total|Total of all reporting groups
10872354|NCT00422734|FG000|Participant Flow|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
10872355|NCT00422734|FG001|Participant Flow|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
10872356|NCT00422734|OG000|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
10872357|NCT00422734|OG001|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
10872358|NCT00422734|EG000|Reported Event|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
10872359|NCT00422734|EG001|Reported Event|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
10872360|NCT00422799|BG000|Baseline|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
10872361|NCT00422799|FG000|Participant Flow|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
10872362|NCT00422799|OG000|Outcome|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
10872363|NCT00422799|EG000|Reported Event|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
10872364|NCT00422812|BG000|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
10872365|NCT00422812|BG001|Baseline|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
10872366|NCT00422812|BG002|Baseline|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
10872367|NCT00422812|BG003|Baseline|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
10872368|NCT00422812|BG004|Baseline|Total|Total of all reporting groups
10872369|NCT00422812|FG000|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
10872370|NCT00422812|FG001|Participant Flow|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
10872371|NCT00422812|FG002|Participant Flow|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
10872372|NCT00422812|FG003|Participant Flow|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
10872373|NCT00422812|OG000|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
10872374|NCT00422812|OG001|Outcome|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
10872375|NCT00422812|OG002|Outcome|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
10872376|NCT00422812|OG003|Outcome|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
10872377|NCT00422812|EG000|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
10872378|NCT00422812|EG001|Reported Event|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
10872379|NCT00422812|EG002|Reported Event|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
11348157|NCT04207333|EG001|Reported Event|Brief Sitting With Mental Stress|"Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.~Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes"
10872380|NCT00422812|EG003|Reported Event|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
10872381|NCT00422903|BG000|Baseline|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
10872382|NCT00422903|BG001|Baseline|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery
10872383|NCT00422903|BG002|Baseline|Total|Total of all reporting groups
10872384|NCT00422903|FG000|Participant Flow|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
10872385|NCT00422903|FG001|Participant Flow|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
10872386|NCT00422903|OG000|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
10872387|NCT00422903|OG001|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
10872388|NCT00422903|EG000|Reported Event|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
10872389|NCT00422903|EG001|Reported Event|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
10872390|NCT00423046|BG000|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872391|NCT00423046|BG001|Baseline|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872392|NCT00423046|BG002|Baseline|Total|Total of all reporting groups
10872393|NCT00423046|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872394|NCT00423046|FG001|Participant Flow|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872395|NCT00423046|OG000|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872396|NCT00423046|OG001|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872397|NCT00423046|OG000|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872398|NCT00423046|OG001|Outcome|Gardasil Group|Gardasil Group Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872399|NCT00423046|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872400|NCT00423046|EG001|Reported Event|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
10872401|NCT00423085|BG000|Baseline|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
10872402|NCT00423085|BG001|Baseline|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
10872403|NCT00423085|BG002|Baseline|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
10872404|NCT00423085|BG003|Baseline|Total|Total of all reporting groups
10872405|NCT00423085|FG000|Participant Flow|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
11348158|NCT04207840|BG000|Baseline|All Study Participants|All participants who have been randomized.
10977679|NCT00946153|EG003|Reported Event|Phase 1: Group 2: Lenvatinib: 12 mg|Participants with CP scores of 7 or 8 received 12 mg (three 4 mg tablets) lenvatinib orally QD in a 28-day treatment cycle in the dose-determination scheme (group 2) on an empty stomach or at least 1 hour after eating.
10977680|NCT00946153|EG004|Reported Event|Phase 2: Lenvatinib: 12 mg|Participants with CP scores of 5 or 6 received lenvatinib RD of 12 mg (three 4 mg tablets) established from group 1 in the dose escalation component (Phase1) study, orally QD in a 28-day treatment cycle in dose expansion component on an empty stomach or at least 1 hour after eating.
10977681|NCT00946192|BG000|Baseline|Estrogen Patch|"17Beta-estradiol transdermal patch twice weekly application for 12 months~Transdermal 17Beta-estradiol, progesterone: 100 mcg/day 17Beta-estradiol; transdermal twice weekly application for 12 months (with cyclic micronized progesterone pills (Prometrium): 200 mg taken orally daily Day 1 to Day 12 each month) + Elemental calcium 1200 mg and Vit D 400 IU taken orally daily"
10977682|NCT00946192|BG001|Baseline|Estrogen Pill|"One pill containing estrogen and progesterone taken daily for 21 days followed by placebo pills only for 7 days; regimen repeated for 12 months.~Ethinyl Estradiol + Desogestrel: Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily"
10977683|NCT00946192|BG002|Baseline|Control|"Elemental calcium 1200 mg and Vit D 400 IU taken orally daily~Sham Comparator: Elemental calcium 1200 mg and Vit D 400 IU taken orally daily"
10977684|NCT00946192|BG003|Baseline|Total|Total of all reporting groups
10977685|NCT00946192|FG000|Participant Flow|Estrogen Patch|"17Beta-estradiol transdermal patch twice weekly application for 12 months~Transdermal 17Beta-estradiol, progesterone: 100 mcg/day 17Beta-estradiol; transdermal twice weekly application for 12 months (with cyclic micronized progesterone pills (Prometrium): 200 mg taken orally daily Day 1 to Day 12 each month) + Elemental calcium 1200 mg and Vit D 400 IU taken orally daily"
10977686|NCT00946192|FG001|Participant Flow|Estrogen Pill|"One pill containing estrogen and progesterone taken daily for 21 days followed by placebo pills only for 7 days; regimen repeated for 12 months.~Ethinyl Estradiol + Desogestrel: Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily"
10977687|NCT00946192|FG002|Participant Flow|Control|"Elemental calcium 1200 mg and Vit D 400 IU taken orally daily~Sham Comparator: Elemental calcium 1200 mg and Vit D 400 IU taken orally daily"
10977688|NCT00946192|OG000|Outcome|Estrogen Patch|"17Beta-estradiol transdermal patch twice weekly application for 12 months~Transdermal 17Beta-estradiol, progesterone: 100 mcg/day 17Beta-estradiol; transdermal twice weekly application for 12 months (with cyclic micronized progesterone pills (Prometrium): 200 mg taken orally daily Day 1 to Day 12 each month) + Elemental calcium 1200 mg and Vit D 400 IU taken orally daily"
10977689|NCT00946192|OG001|Outcome|Estrogen Pill|"One pill containing estrogen and progesterone taken daily for 21 days followed by placebo pills only for 7 days; regimen repeated for 12 months.~Ethinyl Estradiol + Desogestrel: Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily"
10977690|NCT00946192|OG002|Outcome|Control|"Elemental calcium 1200 mg and Vit D 400 IU taken orally daily~Sham Comparator: Elemental calcium 1200 mg and Vit D 400 IU taken orally daily"
10977691|NCT00946192|EG000|Reported Event|Estrogen Patch|"17Beta-estradiol transdermal patch twice weekly application for 12 months~Transdermal 17Beta-estradiol, progesterone: 100 mcg/day 17Beta-estradiol; transdermal twice weekly application for 12 months (with cyclic micronized progesterone pills (Prometrium): 200 mg taken orally daily Day 1 to Day 12 each month) + Elemental calcium 1200 mg and Vit D 400 IU taken orally daily"
10977692|NCT00946192|EG001|Reported Event|Estrogen Pill|"One pill containing estrogen and progesterone taken daily for 21 days followed by placebo pills only for 7 days; regimen repeated for 12 months.~Ethinyl Estradiol + Desogestrel: Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily"
10977693|NCT00946192|EG002|Reported Event|Control|"Elemental calcium 1200 mg and Vit D 400 IU taken orally daily~Sham Comparator: Elemental calcium 1200 mg and Vit D 400 IU taken orally daily"
10977694|NCT00946270|BG000|Baseline|Group 1 CC-4047|CC-4047 3.0 mg orally daily starting on day 1 through 21.
10977695|NCT00946270|BG001|Baseline|Group 2 CC-4047|CC-4047 0.5 mg orally daily starting on day 1 through 28.
10977696|NCT00946270|BG002|Baseline|Group 3 CC-4047 + Predniaone|"CC-4047 0.5 mg orally daily. Prednisone given during first 3 cycles of therapy. It will be dosed orally at the dose of 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.~CC-4047: 0.5 mg capsules daily by mouth day 1 through day 28.~Prednisone: 30 mg by mouth daily during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."
10977697|NCT00946270|BG003|Baseline|Total|Total of all reporting groups
10977698|NCT00946270|FG000|Participant Flow|Group 1: Oral CC-4047 3.0 mg|"CC-4047 3.0 mg orally daily.~CC-4047: 3.0 mg orally daily starting on day 1 through 21."
10977699|NCT00946270|FG001|Participant Flow|Group 2: Oral CC-4047 0.5 mg|"CC-4047 0.5 mg orally daily .~CC-4047: 0.5 mg orally daily starting on day 1 through 28."
10977700|NCT00946270|FG002|Participant Flow|Group 3: Oral CC-4047 0.5 mg + Prednisone|"CC-4047 0.5 mg orally daily. Prednisone given during first 3 cycles of therapy. It will be dosed orally at the dose of 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.~CC-4047: 0.5 mg capsules daily by mouth day 1 through day 28.~Prednisone: 30 mg by mouth daily during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."
10977701|NCT00946270|OG000|Outcome|Group 1 CC-4047|CC-4047 3.0 mg orally daily starting on day 1 through 21
10977702|NCT00946270|OG001|Outcome|Group 2|CC-4047 0.5 mg orally daily starting on day 1 through 28.
10977703|NCT00946270|OG002|Outcome|Group 3 CC-4047 + Prednisone|"CC-4047 0.5 mg orally daily. Prednisone given during first 3 cycles of therapy. It will be dosed orally at the dose of 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.~CC-4047: 0.5 mg capsules daily by mouth day 1 through day 28.~Prednisone: 30 mg by mouth daily during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."
10977704|NCT00946270|EG000|Reported Event|Group 1 CC-4047|CC-4047 3.0 mg orally daily starting on day 1 through 21.
10977705|NCT00946270|EG001|Reported Event|Group 2 CC-4047|CC-4047 0.5 mg orally daily starting on day 1 through 28.
10977706|NCT00946270|EG002|Reported Event|Group 3 CC-4047 + Prednisone|"CC-4047 0.5 mg orally daily. Prednisone given during first 3 cycles of therapy. It will be dosed orally at the dose of 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.~CC-4047: 0.5 mg capsules daily by mouth day 1 through day 28.~Prednisone: 30 mg by mouth daily during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."
10977707|NCT00946296|BG000|Baseline|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
10977708|NCT00946296|BG001|Baseline|No Treatment|The experimental group receives no treatment.
10977709|NCT00946296|BG002|Baseline|Total|Total of all reporting groups
10977710|NCT00946296|FG000|Participant Flow|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
10977711|NCT00946296|FG001|Participant Flow|No Treatment|The experimental group receives no treatment.
10977712|NCT00946296|OG000|Outcome|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
10977713|NCT00946296|OG001|Outcome|No Treatment|The experimental group receives no treatment.
10977714|NCT00946296|EG000|Reported Event|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
10977715|NCT00946296|EG001|Reported Event|No Treatment|The experimental group receives no treatment.
10977716|NCT00946309|BG000|Baseline|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
10977717|NCT00946309|BG001|Baseline|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
10977718|NCT00946309|BG002|Baseline|Total|Total of all reporting groups
10977719|NCT00946309|FG000|Participant Flow|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
10977720|NCT00946309|FG001|Participant Flow|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
10977721|NCT00946309|OG000|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
10977722|NCT00946309|OG001|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
10977723|NCT00946309|OG001|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
10977724|NCT00946309|EG000|Reported Event|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
10977725|NCT00946309|EG001|Reported Event|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
10977726|NCT00946322|BG000|Baseline|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
10977727|NCT00946322|FG000|Participant Flow|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
10977728|NCT00946322|OG000|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
10977729|NCT00946322|EG000|Reported Event|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
10977730|NCT00946348|BG000|Baseline|Dronabinol|Dronabinol 15 mg
10977731|NCT00946348|BG001|Baseline|Cannabis|Cannabis cigarette (3.6% THC)
10977732|NCT00946348|BG002|Baseline|Total|Total of all reporting groups
10977733|NCT00946348|FG000|Participant Flow|Dronabinol|Dronabinol 15 mg
10977734|NCT00946348|FG001|Participant Flow|Cannabis|Cannabis cigarette (3.6% THC)
10977735|NCT00946348|OG000|Outcome|Dronabinol|Dronabinol 15 mg
10977736|NCT00946348|OG001|Outcome|Cannabis|Cannabis cigarette (3.6% THC)
10977737|NCT00946348|EG000|Reported Event|Dronabinol|Dronabinol 15 mg
10977738|NCT00946348|EG001|Reported Event|Cannabis|Cannabis cigarette (3.6% THC)
10977739|NCT00946478|BG000|Baseline|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
10977740|NCT00946478|BG001|Baseline|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
10977741|NCT00946478|BG002|Baseline|Total|Total of all reporting groups
10977742|NCT00946478|FG000|Participant Flow|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
10977743|NCT00946478|FG001|Participant Flow|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
10977744|NCT00946478|OG000|Outcome|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
10977745|NCT00946478|OG001|Outcome|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
10977746|NCT00946478|EG000|Reported Event|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
10977747|NCT00946478|EG001|Reported Event|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
10977748|NCT00946530|BG000|Baseline|Bright Light-AD Patients|AD patients received bright light
10977749|NCT00946530|BG001|Baseline|Dim Light (Control) - AD Patients|AD patients received dim light in the Control condition
10977750|NCT00946530|BG002|Baseline|Bright Light - Caregivers|Caregivers received bright light
10977751|NCT00946530|BG003|Baseline|Dim Light (Control) - Caregivers|Caregivers received dim light in the Control condition
10977752|NCT00946530|BG004|Baseline|Total|Total of all reporting groups
10977753|NCT00946530|FG000|Participant Flow|Bright Light - AD Patient|AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
10977754|NCT00946530|FG001|Participant Flow|Dim Light (Control) - AD Patients|AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
10977755|NCT00946530|FG002|Participant Flow|Bright Light - Caregiver|Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
10977756|NCT00946530|FG003|Participant Flow|Dim Light (Control) - Caregiver|Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
10977757|NCT00946530|OG000|Outcome|Bright Light - AD Patient|AD patient received bright light
10977758|NCT00946530|OG001|Outcome|Dim Light (Control) - AD Patients|AD patient received regular (dim) light
10977759|NCT00946530|OG002|Outcome|Bright Light - Caregiver|Caregiver received Bright Light
10977760|NCT00946530|OG003|Outcome|Dim Light (Control) - Caregiver|Caregiver received regular (dim) Light
10977761|NCT00946530|OG000|Outcome|Bright Light - AD Patient|AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
10977762|NCT00946530|OG001|Outcome|Dim Light (Control) - AD Patients|AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
10977763|NCT00946530|OG002|Outcome|Bright Light - Caregiver|Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
10977764|NCT00946530|OG003|Outcome|Dim Light (Control) - Caregiver|Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
10977765|NCT00946530|EG000|Reported Event|Bright Light-AD Patients|AD patients received bright light
10977766|NCT00946530|EG001|Reported Event|Dim Light (Control) - AD Patients|AD patients received dim light in the Control condition
10977767|NCT00946530|EG002|Reported Event|Bright Light - Caregivers|Caregivers received bright light
10977768|NCT00946530|EG003|Reported Event|Dim Light (Control) - Caregivers|Caregivers received dim light in the Control condition
10977769|NCT00946647|BG000|Baseline|PAN + 5-Aza 20 mg|In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
10977770|NCT00946647|BG001|Baseline|PAN + 5-Aza 30 mg|In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
10977771|NCT00946647|BG002|Baseline|PAN + 5-Aza 40 mg|In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
10977772|NCT00946647|BG003|Baseline|Panobinostat + 5-Azacytidine|"In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.~In both phases, dose of 5-Azacytidine was 75 mg/m^2, subcutaneously Daily for Day 1 to Day 7."
10977773|NCT00946647|BG004|Baseline|5-Azacytidine|"The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.~Dose of 5-Azacytidine : 75 mg/m^2 subcutaneously daily from Day 1 to Day 7."
10977774|NCT00946647|BG005|Baseline|Total|Total of all reporting groups
10977775|NCT00946647|FG000|Participant Flow|PAN + 5-Aza 20 mg|In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
10977776|NCT00946647|FG001|Participant Flow|PAN + 5-Aza 30 mg|In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
10977777|NCT00946647|FG002|Participant Flow|PAN + 5-Aza 40 mg|In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
10977778|NCT00946647|FG003|Participant Flow|Panobinostat + 5-Azacytidine|"In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.~In both phases, dose of 5-Azacytidine was 75 mg/m^2, subcutaneously Daily for Day 1 to Day 7."
10977779|NCT00946647|FG004|Participant Flow|5-Azacytidine|"The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.~Dose of 5-Azacytidine : 75 mg/m^2 subcutaneously daily from Day 1 to Day 7."
10977780|NCT00946647|OG000|Outcome|PAN + 5-Aza 20 mg|In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
10977781|NCT00946647|OG001|Outcome|PAN + 5-Aza 30 mg|In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
10977782|NCT00946647|OG002|Outcome|PAN + 5-Aza 40 mg|In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
10977783|NCT00946647|OG000|Outcome|Panobinostat + 5-Azacytidine|"In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.~In both phases, dose of 5-Azacytidine was 75 mg/m^2, subcutaneously Daily for Day 1 to Day 7."
10977784|NCT00946647|OG001|Outcome|5-Azacytidine|"The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.~Dose of 5-Azacytidine : 75 mg/m^2 subcutaneously daily from Day 1 to Day 7."
10977785|NCT00946647|EG000|Reported Event|Phase Ib PAN + 5-Aza 20mg|In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 g/m2/day for 7 days in Week 1 of each cycle
10977786|NCT00946647|EG001|Reported Event|Phase Ib PAN + 5-Aza 30mg|In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
10977787|NCT00946647|EG002|Reported Event|Phase Ib PAN + 5-Aza 40mg|In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
10977788|NCT00946647|EG003|Reported Event|Phase IIb PAN + 5-Aza|"In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.~In both phases, dose of 5-Azacytidine was 75 mg/m^2, subcutaneously Daily for Day 1 to Day 7."
10977789|NCT00946647|EG004|Reported Event|Phase IIb 5-Aza|"The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.~Dose of 5-Azacytidine: 75 mg/m^2 subcutaneously daily from Day 1 to Day"
10977790|NCT00946647|EG005|Reported Event|Phase Ib and IIb|Patients in the Panobinostat + 5-Azacytidine arm and in the 5-Azacytidine arm
10977791|NCT00946712|BG000|Baseline|Arm I (Chemo +/- Bevacizumab)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977792|NCT00946712|BG001|Baseline|Arm II (Chemo, Cetuximab, +/- Bevacizumab)|"Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977793|NCT00946712|BG002|Baseline|Total|Total of all reporting groups
10977794|NCT00946712|FG000|Participant Flow|Arm I (Chemo +/- Bevacizumab)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977795|NCT00946712|FG001|Participant Flow|Arm II (Chemo, Cetuximab, +/- Bevacizumab)|"Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977796|NCT00946712|OG000|Outcome|Arm I (Chemo +/- Bevacizumab)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977797|NCT00946712|OG001|Outcome|Arm II (Chemo, Cetuximab, +/- Bevacizumab)|"Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977798|NCT00946712|OG000|Outcome|Arm I (Chemo +/- Bevacizumab)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977799|NCT00946712|EG000|Reported Event|Arm I (Chemo +/- Bevacizumab)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977800|NCT00946712|EG001|Reported Event|Arm II (Chemo, Cetuximab, +/- Bevacizumab)|"Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10977801|NCT00946881|BG000|Baseline|WST 11(TOOKAD® Soluble)|"WST 11-mediated-VTP~WST 11 -mediated -VTP: The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance."
10977802|NCT00946881|FG000|Participant Flow|WST 11(TOOKAD® Soluble)|"WST 11-mediated-VTP~WST 11 -mediated -VTP: The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance."
10977803|NCT00946881|OG000|Outcome|2 mg/Kg-200 J/cm|Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
10977804|NCT00946881|OG001|Outcome|2 mg/Kg-300 J/cm|Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
10977805|NCT00946881|OG002|Outcome|4 mg/Kg-200 J/cm|Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
10977806|NCT00946881|OG003|Outcome|All Doses/Energies|Number of patients with positives or négatives biopsies at all doses/energies
10977807|NCT00946881|OG000|Outcome|2 mg/Kg-200 J/cm|Number of patients with negative biopsies at the dose 2mg/Kg-200J/cm
10977808|NCT00946881|OG001|Outcome|2 mg/Kg-300 J/cm|Number of patients with negative biopsies at the dose 2mg/Kg-300J/cm
10977809|NCT00946881|OG002|Outcome|4 mg/Kg-200 J/cm|Number of patients with negative biopsies at the dose 4mg/Kg-200J/cm
10977810|NCT00946881|OG003|Outcome|All Doses/Energies|Number of patients with negative biopsies at all doses/energies
10977811|NCT00946881|OG000|Outcome|2 mg/kg|Patients treated at the dose of 2 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
10977812|NCT00946881|OG001|Outcome|4 mg/kg|Patients treated at the dose of 4 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
10977813|NCT00946881|OG000|Outcome|2 mg/Kg-200 J/cm|To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 2 mg/kg-200J/cm
10977814|NCT00946881|OG001|Outcome|2 mg/Kg-300 J/cm|To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 2 mg/kg-300J/cm
10977815|NCT00946881|OG002|Outcome|4 mg/Kg-200 J/cm|To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 4 mg/kg-200J/cm
10977816|NCT00946881|OG003|Outcome|All Doses/Energies|To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with all doses/energies
10977817|NCT00946881|OG000|Outcome|2 mg/Kg-200 J/cm|To assess the QoL-IIEF in patients treated with the dose 2mg/Kg-200J/cm
10977818|NCT00946881|OG001|Outcome|2 mg/Kg-300 J/cm|To assess the QoL-IIEF in patients treated with the dose 2mg/Kg-300J/cm
10977819|NCT00946881|OG002|Outcome|4 mg/Kg-200 J/cm|To assess the QoL-IIEF in patients treated with the dose 4mg/Kg-200J/cm
10977820|NCT00946881|OG003|Outcome|All Doses/Energies|To assess the QoL-IIEF in patients treated with all doses/energies
10977821|NCT00946881|OG000|Outcome|2 mg/Kg-200 J/cm|To assess the QoL-IPSS in patients treated with the dose 2mg/Kg-200J/cm
10977822|NCT00946881|OG001|Outcome|2 mg/Kg-300 J/cm|To assess the QoL-IPSS in patients treated with the dose 2mg/Kg-300J/cm
10977823|NCT00946881|OG002|Outcome|4 mg/Kg-200 J/cm|To assess the QoL-IPSS in patients treated with the dose 4mg/Kg-200J/cm
10977824|NCT00946881|OG003|Outcome|All Doses/Energies|To assess the QoL-IPSS in patients treated with all doses/energies
10977825|NCT00946881|EG000|Reported Event|WST 11(TOOKAD® Soluble)|"WST 11-mediated-VTP The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers using 753 nm laser light at escalating fixed energy doses~WST 11 -mediated -VTP: The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance."
10977826|NCT00946920|BG000|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
10977827|NCT00946920|BG001|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
10977828|NCT00946920|BG002|Baseline|Total|Total of all reporting groups
10977829|NCT00946920|FG000|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
10977830|NCT00946920|FG001|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
10977831|NCT00946920|OG000|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
10977832|NCT00946920|OG001|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
10977833|NCT00946920|EG000|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
10977834|NCT00946920|EG001|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
10977835|NCT00946998|BG000|Baseline|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
10977836|NCT00946998|BG001|Baseline|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
10977837|NCT00946998|BG002|Baseline|Total|Total of all reporting groups
10977838|NCT00946998|FG000|Participant Flow|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
10848579|NCT00290498|EG000|Reported Event|RHCVAD|Rituximab 375mg/m2 intravenously on day 1,cyclophosphamide 300mg/m2 intravenously every 12 h for six doses on days 13,doxorubicin 50mg/m2 intravenously on day 5,vincristine 1.4mg/m2 or maximum 2mg intravenously on days 5 and 12,and dexamethasone 40mg intravenously or orally on days 25,alternating with RMA(cycles 2,4,6,)rituximab 375mg/2 intravenously on day 1,methotrexate 200mg/m2 over 2 h followed by 800mg/m2 over 22 h on day 1, and cytarabine 3g/m2 every 12 h for four doses on days 3 and 4, with a 21 day cycle.
10848580|NCT00290498|EG001|Reported Event|RCHOP|RCHOP consisted of rituximab 375mg/m2 intravenously on day 1,cyclophosphamide 750mg/m2 intravenously on day 1,doxorubicin 50mg/m2 intravenously on day 1 either over 15min or 48 h , vincristine 1.4mg/m2 or maximum 2mg intravenously,and prednisone 100mg orally on days 15,with a 21d cycle.
10977839|NCT00946998|FG001|Participant Flow|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
10848581|NCT00290537|BG000|Baseline|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
10848582|NCT00290537|FG000|Participant Flow|Part One: ZD6474|First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks
10848583|NCT00290537|FG001|Participant Flow|Part Two: ZD6474 + Carboplatin + Paclitaxel|Second part of two part treatment, Part One /Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks.
10848584|NCT00290537|OG000|Outcome|ZD6474|First part of treatment: three 3-week cycles 300 mg of ZD6474 daily. Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
10848585|NCT00290537|OG001|Outcome|ZD6474 + Carboplatin + Paclitaxel|Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
10848586|NCT00290537|EG000|Reported Event|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
10848587|NCT00290589|BG000|Baseline|Intramuscular Methylprednisolone Acetate|"Methylprednisolone acetate 160mg intramuscular injection~intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg"
10848588|NCT00290589|BG001|Baseline|Placebo|"Placebo intramuscular injection~Placebo: Normal saline intramuscular injection"
10848589|NCT00290589|BG002|Baseline|Total|Total of all reporting groups
10848590|NCT00290589|FG000|Participant Flow|Intramuscular Methylprednisolone Acetate|"Methylprednisolone acetate 160mg intramuscular injection~intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg"
10848591|NCT00290589|FG001|Participant Flow|Placebo|"Placebo intramuscular injection~Placebo: Normal saline intramuscular injection"
10848592|NCT00290589|OG000|Outcome|Intramuscular Methylprednisolone Acetate|"Methylprednisolone acetate 160mg intramuscular injection~intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg"
10848593|NCT00290589|OG001|Outcome|Placebo|"Placebo intramuscular injection~Placebo: Normal saline intramuscular injection"
10848594|NCT00290589|EG000|Reported Event|Intramuscular Methylprednisolone Acetate|"Methylprednisolone acetate 160mg intramuscular injection~intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg"
10848595|NCT00290589|EG001|Reported Event|Placebo|"Placebo intramuscular injection~Placebo: Normal saline intramuscular injection"
10848596|NCT00290615|BG000|Baseline|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
10848597|NCT00290615|FG000|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
10848598|NCT00290615|OG000|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
10848599|NCT00290615|EG000|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
10848600|NCT00290654|BG000|Baseline|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
10977840|NCT00946998|OG000|Outcome|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
10977841|NCT00946998|OG001|Outcome|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
10977842|NCT00946998|EG000|Reported Event|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
10977843|NCT00946998|EG001|Reported Event|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
10977844|NCT00947115|BG000|Baseline|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977845|NCT00947115|BG001|Baseline|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977846|NCT00947115|BG002|Baseline|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977847|NCT00947115|BG003|Baseline|Total|Total of all reporting groups
10977848|NCT00947115|FG000|Participant Flow|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977849|NCT00947115|FG001|Participant Flow|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977850|NCT00947115|FG002|Participant Flow|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977851|NCT00947115|OG000|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977852|NCT00947115|OG001|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977853|NCT00947115|OG002|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977854|NCT00947115|EG000|Reported Event|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977855|NCT00947115|EG001|Reported Event|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977856|NCT00947115|EG002|Reported Event|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
10977857|NCT00947154|BG000|Baseline|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
10977858|NCT00947154|FG000|Participant Flow|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
10977859|NCT00947154|OG000|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
10872406|NCT00423085|FG001|Participant Flow|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
10872407|NCT00423085|FG002|Participant Flow|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
10872408|NCT00423085|FG003|Participant Flow|Open-label Extension|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
10872409|NCT00423085|OG000|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
10872410|NCT00423085|OG001|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
10872411|NCT00423085|OG002|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
10872412|NCT00423085|OG000|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
10872413|NCT00423085|EG000|Reported Event|Placebo (24 Weeks)|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
10872414|NCT00423085|EG001|Reported Event|Rivastigmine 5 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
10872415|NCT00423085|EG002|Reported Event|Rivastigmine 10 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 patch for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
10872416|NCT00423085|EG003|Reported Event|Open-Label Extension (52 Weeks)|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
10872417|NCT00423098|BG000|Baseline|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
10872418|NCT00423098|BG001|Baseline|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
10872419|NCT00423098|BG002|Baseline|Total|Total of all reporting groups
10872420|NCT00423098|FG000|Participant Flow|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
10872421|NCT00423098|FG001|Participant Flow|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
10977860|NCT00947154|OG000|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
10977861|NCT00947154|EG000|Reported Event|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
10977862|NCT00947167|BG000|Baseline|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
10977863|NCT00947167|FG000|Participant Flow|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
10977864|NCT00947167|OG000|Outcome|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
10977865|NCT00947167|EG000|Reported Event|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
10977866|NCT00947193|BG000|Baseline|Ataluren Overall Study|Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 5 mg/kg in the morning, 5 mg/kg at midday, and 10 mg/kg in the evening or 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by an interval of 14 days without treatment.
10977867|NCT00947193|FG000|Participant Flow|5 mg/kg, 5 mg/kg, and 10 mg/kg Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 5 milligrams/kilograms (mg/kg) in the morning, 5 mg/kg at midday, and 10 mg/kg in the evening for 14 days, followed by an interval of 14 days without treatment.
10977868|NCT00947193|FG001|Participant Flow|10 mg/kg, 10 mg/kg, and 20 mg/kg Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by an interval of 14 days without treatment.
10977869|NCT00947193|OG000|Outcome|10 mg/kg, 10 mg/kg, and 20 mg/kg Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by an interval of 14 days without treatment.
10977870|NCT00947193|OG000|Outcome|Ataluren Overall Study|Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 5 mg/kg in the morning, 5 mg/kg at midday, and 10 mg/kg in the evening or 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by an interval of 14 days without treatment.
10977871|NCT00947193|EG000|Reported Event|Ataluren Overall Study|Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 5 mg/kg in the morning, 5 mg/kg at midday, and 10 mg/kg in the evening or 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by an interval of 14 days without treatment.
10977872|NCT00947219|BG000|Baseline|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
10977873|NCT00947219|BG001|Baseline|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
10977874|NCT00947219|BG002|Baseline|Control Device|Control device emitting LED light
10977875|NCT00947219|BG003|Baseline|Total|Total of all reporting groups
10977876|NCT00947219|FG000|Participant Flow|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
10977877|NCT00947219|FG001|Participant Flow|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
10977878|NCT00947219|FG002|Participant Flow|Control Device|Control device emitting LED light
10977879|NCT00947219|OG000|Outcome|HairMax LaserComb 2009, 12 Beam|The active LLLT Device 2009 with 12 laser modules
10977880|NCT00947219|OG001|Outcome|HairMax LaserComb 2009 9 Beam|the active LLLT Device 2009 9 laser modules
10977881|NCT00947219|OG002|Outcome|Control Device|Control device emitting white light
10977882|NCT00947219|EG000|Reported Event|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
10977883|NCT00947219|EG001|Reported Event|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
10977884|NCT00947219|EG002|Reported Event|Control Device|Control device emitting LED light
10977885|NCT00947271|BG000|Baseline|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
10977886|NCT00947271|BG001|Baseline|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
10977887|NCT00947271|BG002|Baseline|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
10977888|NCT00947271|BG003|Baseline|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
10977889|NCT00947271|BG004|Baseline|Total|Total of all reporting groups
10872422|NCT00423098|OG000|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
10872423|NCT00423098|OG001|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
10872424|NCT00423098|EG000|Reported Event|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
10872425|NCT00423098|EG001|Reported Event|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
10872426|NCT00423137|BG000|Baseline|Placebo 15 Milligram b.i.d|Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872427|NCT00423137|BG001|Baseline|Placebo 30 Milligram b.i.d|Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872428|NCT00423137|BG002|Baseline|BIBW2948 15 Milligram b.i.d|Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872429|NCT00423137|BG003|Baseline|BIBW2948 30 Milligram b.i.d|Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872430|NCT00423137|BG004|Baseline|Total|Total of all reporting groups
10872431|NCT00423137|FG000|Participant Flow|Placebo 15 Milligram b.i.d|Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872432|NCT00423137|FG001|Participant Flow|Placebo 30 Milligram b.i.d|Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872433|NCT00423137|FG002|Participant Flow|BIBW2948 15 Milligram b.i.d|Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872434|NCT00423137|FG003|Participant Flow|BIBW2948 30 Milligram b.i.d|Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872435|NCT00423137|OG000|Outcome|Placebo Total|All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872436|NCT00423137|OG001|Outcome|BIBW2948 Total|All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872437|NCT00423137|OG000|Outcome|Placebo Total|All patients on Placebo Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d).
10872438|NCT00423137|OG001|Outcome|BIBW2948 Total|All patients on BIBW2948 Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d).
10872439|NCT00423137|EG000|Reported Event|Placebo 15 Milligram b.i.d|Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872440|NCT00423137|EG001|Reported Event|Placebo 30 Milligram b.i.d|Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872441|NCT00423137|EG002|Reported Event|Placebo Total|All patients on Placebo Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d).
10872442|NCT00423137|EG003|Reported Event|BIBW2948 15 Milligram b.i.d|Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872443|NCT00423137|EG004|Reported Event|BIBW2948 30 Milligram b.i.d|Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
10872444|NCT00423137|EG005|Reported Event|BIBW2948 Total|All patients on BIBW2948 Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d).
10872445|NCT00423137|EG006|Reported Event|Total|All patients in the study combined. (Placebo + BIBW2948)
10872446|NCT00423150|BG000|Baseline|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
10872447|NCT00423150|FG000|Participant Flow|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
10872448|NCT00423150|OG000|Outcome|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
10872449|NCT00423150|EG000|Reported Event|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
10872450|NCT00423189|BG000|Baseline|Arm 1|drug - intravitreal ranibizumab
10872451|NCT00423189|BG001|Baseline|Arm 2|40% fluence photodynamic therapy - procedure
10872452|NCT00423189|BG002|Baseline|Arm 3|20% fluence photodynamic therapy - procedure
10872453|NCT00423189|BG003|Baseline|Total|Total of all reporting groups
10872454|NCT00423189|FG000|Participant Flow|Ranibizumab Only|drug - intravitreal ranibizumab
10872455|NCT00423189|FG001|Participant Flow|Ranibizumab and 40% Fluence PDT(Procedure)|40% fluence photodynamic therapy - procedure
10872456|NCT00423189|FG002|Participant Flow|Ranibizumab and 20% Fluence PDT(Procedure)|20% fluence photodynamic therapy - procedure
10872457|NCT00423189|OG000|Outcome|Ranibizumab Only|IVT Ranibizumab only
10872458|NCT00423189|OG001|Outcome|40% Fluence PDT/Ranibizumab|40% Fluence PDT WITH ivt Ranibizumab
10872459|NCT00423189|OG002|Outcome|20% Fluence PDT/Ranibizumab|20% Fluence PDT with IVT Ranibizumab
10872460|NCT00423189|OG000|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
10872461|NCT00423189|OG001|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
10872462|NCT00423189|OG002|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
10872463|NCT00423189|OG001|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy/combined with ranibizumab - procedure
10872464|NCT00423189|OG002|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab - procedure
10872465|NCT00423189|EG000|Reported Event|Ranibizumab Only|subject only received ranibizumab
10872466|NCT00423189|EG001|Reported Event|40% Fluence PDT Combined With Ranibizumab|Subjects who have received 40% fluence PDT combined with as needed dosing with ranibizumab
10872467|NCT00423189|EG002|Reported Event|20% PDT Fluence Combined With Ranibizumab|Subjects who received 20% with as needed ranibizumab
10872468|NCT00423267|BG000|Baseline|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
10872469|NCT00423267|BG001|Baseline|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
10872470|NCT00423267|BG002|Baseline|Total|Total of all reporting groups
10872471|NCT00423267|FG000|Participant Flow|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. One subject from period A declined to participate in the amended protocol and discontinued study treatment after 12 months of study drug administration.
10872472|NCT00423267|FG001|Participant Flow|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
10872473|NCT00423267|OG000|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
10872474|NCT00423267|OG001|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
10872475|NCT00423267|OG000|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
10872476|NCT00423267|EG000|Reported Event|Posaconazole Period A|
10872477|NCT00423267|EG001|Reported Event|Fluconazole Period A|
10872478|NCT00423267|EG002|Reported Event|Posaconazole Period B|
10872479|NCT00423293|BG000|Baseline|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
10872480|NCT00423293|FG000|Participant Flow|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
10872481|NCT00423293|OG000|Outcome|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
10872482|NCT00423293|EG000|Reported Event|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
10977890|NCT00947271|FG000|Participant Flow|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
10977891|NCT00947271|FG001|Participant Flow|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
10977892|NCT00947271|FG002|Participant Flow|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
10977893|NCT00947271|FG003|Participant Flow|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
10977894|NCT00947271|OG000|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
10977895|NCT00947271|OG001|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
10977896|NCT00947271|OG002|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
10977897|NCT00947271|OG003|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
10977898|NCT00947271|EG000|Reported Event|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
10977899|NCT00947271|EG001|Reported Event|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
10977900|NCT00947271|EG002|Reported Event|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
10977901|NCT00947271|EG003|Reported Event|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
10977902|NCT00947297|BG000|Baseline|HPN-100|Patients who were treated with HPN-100
10977903|NCT00947297|FG000|Participant Flow|HPN-100|Patients who were treated with HPN-100
10977904|NCT00947297|OG000|Outcome|HPN-100|Patients who were treated with HPN-100
10977905|NCT00947297|OG000|Outcome|HPN-100|"Patients who were treated with HPN-100~HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
10977906|NCT00947297|EG000|Reported Event|HPN-100|Patients who were treated with HPN-100
10977907|NCT00947310|BG000|Baseline|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
10977908|NCT00947310|BG001|Baseline|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
10977909|NCT00947310|BG002|Baseline|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
10977910|NCT00947310|BG003|Baseline|Total|Total of all reporting groups
10977911|NCT00947310|FG000|Participant Flow|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
10977912|NCT00947310|FG001|Participant Flow|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
10977913|NCT00947310|FG002|Participant Flow|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
10977914|NCT00947310|OG000|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
10977915|NCT00947310|OG001|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
10977916|NCT00947310|OG002|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
10977917|NCT00947310|EG000|Reported Event|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
10977918|NCT00947310|EG001|Reported Event|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
10977919|NCT00947310|EG002|Reported Event|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
10977920|NCT00947349|BG000|Baseline|Placebo in TN Patients|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
10977921|NCT00947349|BG001|Baseline|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
10977922|NCT00947349|BG002|Baseline|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.). with PegIFN/RBV in TN patients
10977923|NCT00947349|BG003|Baseline|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
10977924|NCT00947349|BG004|Baseline|Total|Total of all reporting groups
10977925|NCT00947349|FG000|Participant Flow|Placebo in Treatment Naive (TN) Patients|Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients
10977926|NCT00947349|FG001|Participant Flow|BI 201335 NA Low for Treatment Naive (TN)|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients
10977927|NCT00947349|FG002|Participant Flow|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
10977928|NCT00947349|FG003|Participant Flow|BI 201335 NA High for Treatment Experienced (TE)|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.
10977929|NCT00947349|OG000|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
10977930|NCT00947349|OG001|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
10977931|NCT00947349|OG002|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
10977932|NCT00947349|OG003|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
10977933|NCT00947349|OG000|Outcome|Placebo in TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
10977934|NCT00947349|OG001|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
10977935|NCT00947349|OG002|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
10977936|NCT00947349|OG003|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
10977937|NCT00947349|OG000|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
10977938|NCT00947349|OG000|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
10977939|NCT00947349|OG001|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
10977940|NCT00947349|OG002|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
10977941|NCT00947349|OG003|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
10977942|NCT00947349|OG000|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
10977943|NCT00947349|OG001|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
10977944|NCT00947349|OG002|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
10977945|NCT00947349|OG000|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa-2a in TN patients
10977946|NCT00947349|OG000|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
10977947|NCT00947349|EG000|Reported Event|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
10977948|NCT00947349|EG001|Reported Event|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
10977949|NCT00947349|EG002|Reported Event|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
10977950|NCT00947349|EG003|Reported Event|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
10977951|NCT00947349|EG004|Reported Event|SOC TN Placebo|Standard of care for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
10977952|NCT00947349|EG005|Reported Event|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
10977953|NCT00947349|EG006|Reported Event|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
10977954|NCT00947349|EG007|Reported Event|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
10977955|NCT00947427|BG000|Baseline|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
10977956|NCT00947427|BG001|Baseline|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
10977957|NCT00947427|BG002|Baseline|Total|Total of all reporting groups
10977958|NCT00947427|FG000|Participant Flow|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
10977959|NCT00947427|FG001|Participant Flow|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
10977960|NCT00947427|OG000|Outcome|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
10977961|NCT00947427|OG001|Outcome|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
10977962|NCT00947427|EG000|Reported Event|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
10977963|NCT00947427|EG001|Reported Event|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
10977964|NCT00947505|BG000|Baseline|LLT Device 2009 7 Beam|
10977965|NCT00947505|BG001|Baseline|Control Device|
10977966|NCT00947505|BG002|Baseline|Total|Total of all reporting groups
10977967|NCT00947505|FG000|Participant Flow|LLT Device 2009 7 Beam|
10977968|NCT00947505|FG001|Participant Flow|Control Device|
10977969|NCT00947505|OG000|Outcome|LLT Device 2009 7 Beam|This is the active LLLT device
10977970|NCT00947505|OG001|Outcome|Control Device|This is the control device emitting white light
10977971|NCT00947505|EG000|Reported Event|LLT Device 2009 7 Beam|
10977972|NCT00947505|EG001|Reported Event|Control Device|
10977973|NCT00947531|BG000|Baseline|Cerebrolysin|
10977974|NCT00947531|BG001|Baseline|0.9% Saline Solution|
10977975|NCT00947531|BG002|Baseline|Total|Total of all reporting groups
10977976|NCT00947531|FG000|Participant Flow|Cerebrolysin|
10977977|NCT00947531|FG001|Participant Flow|0.9% Saline Solution|
10977978|NCT00947531|OG000|Outcome|Cerebrolysin|
10977979|NCT00947531|OG001|Outcome|0.9% Saline Solution|
10977980|NCT00947531|EG000|Reported Event|Cerebrolysin|
10977981|NCT00947531|EG001|Reported Event|0.9% Saline Solution|
10977982|NCT00947544|BG000|Baseline|Participants in SO and SE|Patients who completed switch over study and enrolled safety extension study
10977983|NCT00947544|FG000|Participant Flow|Swich Over and Safety Extension|NaPBA was dosed three times daily (TID) with during the first week and the same PBA mole-equivalent dose of HPN-100 during the second week. If there were safety concerns regarding a single-step transition from NaPBA to HPN-100, at the investigator's discretion, the transition could occur in 2 steps such that in the second week, subjects might receive 50% of the PBA equivalent dose as NaPBA and 50% as HPN-100 before receiving 100% of Serial blood samples were collected for PK and blood ammonia assessments after each drug reached steady state, which was achieved approximately 4 days after initiation of 100% NaPBA or HPN100 treatment. After the switch over, participants entered the safety extension part of the study and continued receiving open-label HPN-100 for up to 12 months.
10977984|NCT00947544|FG001|Participant Flow|Safety Extension Only|Participants entered the safety extension part of the study only, and received open-label HPN-100 for up to 12 months.
10977985|NCT00947544|OG000|Outcome|HPN-100|HPN-100: Patients treated with HPN-100
10977986|NCT00947544|OG001|Outcome|NaPBA|NaPBA: Patients treated with NaPBA
10977987|NCT00947544|OG000|Outcome|Pre-Enrollment (NaPBA)|
10977988|NCT00947544|OG001|Outcome|Safety Extension (HPN-100)|
10977989|NCT00947544|OG000|Outcome|HPN-100|Patients treated with HPN-100
10977990|NCT00947544|OG001|Outcome|NaPBA|Patients treated with NaPBA
10977991|NCT00947544|OG000|Outcome|HPN-100|Patients treated with HPN-100 who completed SF-15 at baseline and Month 12
10977992|NCT00947544|EG000|Reported Event|HPN-100|HPN-100: Patient treated with HPN-100
10977993|NCT00947661|BG000|Baseline|SPARC0912|SPARC0912 administered once daily for 12 weeks
10977994|NCT00947661|BG001|Baseline|Reference0912|Reference0912 administered once daily for 12 weeks
10977995|NCT00947661|BG002|Baseline|Total|Total of all reporting groups
10977996|NCT00947661|FG000|Participant Flow|SPARC0912|SPARC0912 administered once daily for 12 weeks
10977997|NCT00947661|FG001|Participant Flow|Reference0912|Reference0912 administered once daily for 12 weeks
10977998|NCT00947661|OG000|Outcome|SPARC0912|The change from baseline in intraocular pressure was calculated. A positive change from baseline suggested a reduction from baseline in intraocular pressure. Change from baseline was analyzed using an analysis of covariance methodology, a two-sided 95% CI for the difference between treatment groups in estimated mean change from baseline (i.e., LS means derived from the ANCOVA model) was computed for each time point at each visit (a total of 12 time points at 4 visits i.e. 3 time points at each visit).
10977999|NCT00947661|OG001|Outcome|Reference0912|
10978000|NCT00947661|EG000|Reported Event|SPARC0912|SPARC's formulation administered once daily for 12 weeks
10978001|NCT00947661|EG001|Reported Event|Reference0912|Reference formulation administered once daily for 12 weeks
10978002|NCT00947752|BG000|Baseline|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
10978003|NCT00947752|BG001|Baseline|F2 Glatiramer Acetate 20mg/0.5ml|
10978004|NCT00947752|BG002|Baseline|Total|Total of all reporting groups
10978005|NCT00947752|FG000|Participant Flow|F1 Glatiramer Acetate 20mg/1.0ml|
10978006|NCT00947752|FG001|Participant Flow|F2 Glatiramer Acetate 20mg/0.5ml|
10978007|NCT00947752|OG000|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
10978008|NCT00947752|OG001|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
10978009|NCT00947752|EG000|Reported Event|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
10978010|NCT00947752|EG001|Reported Event|F2 Glatiramer Acetate 20mg/0.5ml|
10978011|NCT00947765|BG000|Baseline|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
10978012|NCT00947765|BG001|Baseline|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
10978013|NCT00947765|BG002|Baseline|Total|Total of all reporting groups
10978014|NCT00947765|FG000|Participant Flow|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
10978015|NCT00947765|FG001|Participant Flow|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
10978016|NCT00947765|OG000|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
10978017|NCT00947765|OG001|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
10872483|NCT00423319|BG000|Baseline|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10872484|NCT00423319|BG001|Baseline|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
10872485|NCT00423319|BG002|Baseline|Total|Total of all reporting groups
10872486|NCT00423319|FG000|Participant Flow|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10872487|NCT00423319|FG001|Participant Flow|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
10872488|NCT00423319|OG000|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10872489|NCT00423319|OG001|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
10872490|NCT00423319|OG000|Outcome|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10872491|NCT00423319|EG000|Reported Event|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10872492|NCT00423319|EG001|Reported Event|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
10872493|NCT00423332|BG000|Baseline|AZD2171 45 mg|AZD2171 45mg/Day
10872494|NCT00423332|BG001|Baseline|Placebo|Placebo/Day
10872495|NCT00423332|BG002|Baseline|Total|Total of all reporting groups
10872496|NCT00423332|FG000|Participant Flow|AZD2171 45 mg|AZD2171 45mg/Day: 53 patients randomised
10872497|NCT00423332|FG001|Participant Flow|Placebo|Placebo / Day: 18 patients randomised
10872498|NCT00423332|OG000|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
10872499|NCT00423332|OG001|Outcome|Placebo|Placebo/Day
10872500|NCT00423332|EG000|Reported Event|Cediranib DB|Double Blind part
10872501|NCT00423332|EG001|Reported Event|Placebo DB|Double Blind part
10872502|NCT00423332|EG002|Reported Event|Cediranib OL|Open Label part
10872503|NCT00423358|BG000|Baseline|Vitamin D|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
10872504|NCT00423358|BG001|Baseline|Placebo|"matching placebo tablet~placebo: matching placebo"
10872505|NCT00423358|BG002|Baseline|Total|Total of all reporting groups
10872506|NCT00423358|FG000|Participant Flow|Vitamin D|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
10872507|NCT00423358|FG001|Participant Flow|Placebo|"matching placebo tablet~placebo: matching placebo"
10872508|NCT00423358|OG000|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
10872509|NCT00423358|OG001|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
10872510|NCT00423358|EG000|Reported Event|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
10872511|NCT00423358|EG001|Reported Event|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
10872512|NCT00423436|BG000|Baseline|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
10872513|NCT00423436|BG001|Baseline|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
10872514|NCT00423436|BG002|Baseline|Total|Total of all reporting groups
10872515|NCT00423436|FG000|Participant Flow|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
10872516|NCT00423436|FG001|Participant Flow|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
10872517|NCT00423436|OG000|Outcome|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
10872518|NCT00423436|OG001|Outcome|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
10872519|NCT00423436|EG000|Reported Event|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
10872520|NCT00423436|EG001|Reported Event|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
10872521|NCT00423449|BG000|Baseline|All Participants|Vorinostat + Gemcitabine + Cisplatin
10872522|NCT00423449|FG000|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872523|NCT00423449|FG001|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872524|NCT00423449|FG002|Participant Flow|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872525|NCT00423449|FG003|Participant Flow|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872526|NCT00423449|FG004|Participant Flow|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10978018|NCT00947765|EG000|Reported Event|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
10978019|NCT00947765|EG001|Reported Event|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
10978020|NCT00947856|BG000|Baseline|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
10978021|NCT00947856|BG001|Baseline|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
10978022|NCT00947856|BG002|Baseline|Total|Total of all reporting groups
10978023|NCT00947856|FG000|Participant Flow|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
10978024|NCT00947856|FG001|Participant Flow|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
10978025|NCT00947856|OG000|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
10978026|NCT00947856|OG001|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
10978027|NCT00947856|OG002|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
10978028|NCT00947856|OG003|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
10978029|NCT00947856|OG000|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
10978030|NCT00947856|OG001|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
10978031|NCT00947856|OG000|Outcome|BV Extension Total|All patients enrolled and treated on the extension arm
10978032|NCT00947856|OG001|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
10978033|NCT00947856|OG002|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
10978034|NCT00947856|OG003|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
10978035|NCT00947856|OG004|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
10978036|NCT00947856|EG000|Reported Event|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
10978037|NCT00947856|EG001|Reported Event|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
10978038|NCT00947882|BG000|Baseline|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10848601|NCT00290654|FG000|Participant Flow|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
10978039|NCT00947882|BG001|Baseline|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10848602|NCT00290654|OG000|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
10978040|NCT00947882|BG002|Baseline|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978041|NCT00947882|BG003|Baseline|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978042|NCT00947882|BG004|Baseline|Total|Total of all reporting groups
10978043|NCT00947882|FG000|Participant Flow|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
10978044|NCT00947882|FG001|Participant Flow|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978045|NCT00947882|FG002|Participant Flow|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978046|NCT00947882|FG003|Participant Flow|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978047|NCT00947882|OG000|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
10978048|NCT00947882|OG001|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
10978049|NCT00947882|OG002|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978050|NCT00947882|OG003|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978051|NCT00947882|OG001|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978052|NCT00947882|EG000|Reported Event|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978053|NCT00947882|EG001|Reported Event|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978054|NCT00947882|EG002|Reported Event|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978055|NCT00947882|EG003|Reported Event|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
10978056|NCT00948025|BG000|Baseline|Avance Nerve Graft|"Commercially available Avance Nerve Graft for repair of nerve gap~Processed Human Nerve Tissue: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery."
10978057|NCT00948025|BG001|Baseline|Hollow Tube Conduit|"Commercially available hollow tube conduit for repair of nerve gap.~Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)"
10978058|NCT00948025|BG002|Baseline|Total|Total of all reporting groups
10872527|NCT00423449|OG000|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872528|NCT00423449|OG001|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872529|NCT00423449|OG002|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872530|NCT00423449|OG003|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872531|NCT00423449|OG004|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
10872532|NCT00423449|OG000|Outcome|All Participants|Vorinostat + Gemcitabine + Cisplatin
10872533|NCT00423449|EG000|Reported Event|MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin|
10872534|NCT00423449|EG001|Reported Event|MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
10872535|NCT00423449|EG002|Reported Event|MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
10872536|NCT00423449|EG003|Reported Event|MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
10872537|NCT00423449|EG004|Reported Event|MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
10872538|NCT00423592|BG000|Baseline|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
10872539|NCT00423592|FG000|Participant Flow|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
10872540|NCT00423592|OG000|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
10872541|NCT00423592|EG000|Reported Event|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
10872542|NCT00423605|BG000|Baseline|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
10872543|NCT00423605|FG000|Participant Flow|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
10872544|NCT00423605|OG000|Outcome|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
10872545|NCT00423605|EG000|Reported Event|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
10872546|NCT00423657|BG000|Baseline|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
10872547|NCT00423657|BG001|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
10872548|NCT00423657|BG002|Baseline|Total|Total of all reporting groups
10872549|NCT00423657|FG000|Participant Flow|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
10872550|NCT00423657|FG001|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
10872551|NCT00423657|OG000|Outcome|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
10872552|NCT00423657|OG001|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
10872553|NCT00423657|EG000|Reported Event|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
10872554|NCT00423657|EG001|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
10872555|NCT00423670|BG000|Baseline|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
10872556|NCT00423670|BG001|Baseline|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
10872557|NCT00423670|BG002|Baseline|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
10872558|NCT00423670|BG003|Baseline|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
10872559|NCT00423670|BG004|Baseline|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
10978059|NCT00948025|FG000|Participant Flow|Avance Nerve Graft|"Commercially available Avance Nerve Graft for repair of nerve gap~Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery."
10978060|NCT00948025|FG001|Participant Flow|Hollow Tube Conduit|"Commercially available hollow tube conduit for repair of nerve gap.~Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)"
10978061|NCT00948025|OG000|Outcome|Avance Nerve Graft|"Commercially available Avance Nerve Graft for repair of nerve gap~Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery."
10978062|NCT00948025|OG001|Outcome|Hollow Tube Conduit|"Commercially available hollow tube conduit for repair of nerve gap.~Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)"
10978063|NCT00948025|OG000|Outcome|Avance Nerve Graft|"Commercially available Avance Nerve Graft for repair of nerve gap~Processed Human Nerve Tissue: Implantation of appropriate length of processed human nerve tissue at time of surgery."
10978064|NCT00948025|EG000|Reported Event|Avance Nerve Graft|"Commercially available Avance Nerve Graft for repair of nerve gap~Processed Human Nerve Tissue: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery."
10978065|NCT00948025|EG001|Reported Event|Hollow Tube Conduit|"Commercially available hollow tube conduit for repair of nerve gap.~Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)"
10978066|NCT00948064|BG000|Baseline|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
10978067|NCT00948064|BG001|Baseline|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978068|NCT00948064|BG002|Baseline|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978069|NCT00948064|BG003|Baseline|Total|Total of all reporting groups
10978070|NCT00948064|FG000|Participant Flow|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
10978071|NCT00948064|FG001|Participant Flow|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978072|NCT00948064|FG002|Participant Flow|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978073|NCT00948064|OG000|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
10978074|NCT00948064|OG001|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978075|NCT00948064|OG002|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978076|NCT00948064|OG000|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978077|NCT00948064|OG001|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978078|NCT00948064|EG000|Reported Event|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
10978079|NCT00948064|EG001|Reported Event|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978080|NCT00948064|EG002|Reported Event|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
10978081|NCT00948090|BG000|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978082|NCT00948090|BG001|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978083|NCT00948090|BG002|Baseline|Total|Total of all reporting groups
10978084|NCT00948090|FG000|Participant Flow|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978085|NCT00948090|FG001|Participant Flow|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978086|NCT00948090|FG002|Participant Flow|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978087|NCT00948090|FG003|Participant Flow|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978088|NCT00948090|OG000|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978089|NCT00948090|OG001|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978090|NCT00948090|OG002|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978091|NCT00948090|OG003|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
10978092|NCT00948090|EG000|Reported Event|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years)|The safety data set consisted of all screened participants who had received at least 1 dose of IV busulfan (including PK test dose).
10978093|NCT00948155|BG000|Baseline|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
10978094|NCT00948155|BG001|Baseline|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
10978095|NCT00948155|BG002|Baseline|Total|Total of all reporting groups
10978096|NCT00948155|FG000|Participant Flow|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
10978097|NCT00948155|FG001|Participant Flow|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
10978098|NCT00948155|OG000|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
10978099|NCT00948155|OG001|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
10978100|NCT00948155|OG000|Outcome|Placebo|21 days using placebo
10978101|NCT00948155|OG001|Outcome|Varenicline|21 days using Varenicline
10978102|NCT00948155|EG000|Reported Event|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
10978103|NCT00948155|EG001|Reported Event|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
10978104|NCT00948246|BG000|Baseline|Easyband|
10978105|NCT00948246|FG000|Participant Flow|Easyband|
10978106|NCT00948246|OG000|Outcome|Easyband|
10978107|NCT00948246|EG000|Reported Event|Easyband|
10978108|NCT00948298|BG000|Baseline|Placebo|Placebo: Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.
10978109|NCT00948298|BG001|Baseline|Vitamin D|Vitamin D: Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
10978110|NCT00948298|BG002|Baseline|Total|Total of all reporting groups
10978111|NCT00948298|FG000|Participant Flow|Placebo|Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3 will be given every 4 weeks.
10872560|NCT00423670|BG005|Baseline|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
10872561|NCT00423670|BG006|Baseline|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
10872562|NCT00423670|BG007|Baseline|Total|Total of all reporting groups
10872563|NCT00423670|FG000|Participant Flow|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks."
10872564|NCT00423670|FG001|Participant Flow|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
10872565|NCT00423670|FG002|Participant Flow|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
10872566|NCT00423670|FG003|Participant Flow|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
10872567|NCT00423670|FG004|Participant Flow|Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
10872568|NCT00423670|FG005|Participant Flow|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
10872569|NCT00423670|FG006|Participant Flow|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
10872570|NCT00423670|FG007|Participant Flow|Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
10872571|NCT00423670|OG000|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
10872572|NCT00423670|OG001|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
10872573|NCT00423670|OG002|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
10872574|NCT00423670|OG003|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
10872575|NCT00423670|OG004|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
10872576|NCT00423670|OG005|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
10978112|NCT00948298|FG001|Participant Flow|Vitamin D|Two 50,000 IU tablets of oral Vitamin D3 given every 4 weeks.
10978113|NCT00948298|OG000|Outcome|Placebo|Placebo: Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.
10978114|NCT00948298|OG001|Outcome|Vitamin D|Vitamin D: Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
10872577|NCT00423670|OG006|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
10872578|NCT00423670|OG000|Outcome|Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
10872579|NCT00423670|OG001|Outcome|Arm 2 and Arm 4. PEG + RBV + BOC|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
10872580|NCT00423670|OG000|Outcome|Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 48 weeks.
10872581|NCT00423670|OG001|Outcome|Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 28 weeks.
10872582|NCT00423670|EG000|Reported Event|PEG +RBV for 48 Wks (Part I)|"Arm 1. PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks.~Adverse events for 36 participants after they crossed over to Arm 8 are not included."
10872583|NCT00423670|EG001|Reported Event|PEG + RBV + BOC for 28 Wks (Part I)|Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
10872584|NCT00423670|EG002|Reported Event|PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
10872585|NCT00423670|EG003|Reported Event|PEG +RBV + BOC for 48 Wks (Part I)|Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
10872586|NCT00423670|EG004|Reported Event|PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
10872587|NCT00423670|EG005|Reported Event|PEG + RBV + BOC for 48 Wks (Part II)|Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
10872588|NCT00423670|EG006|Reported Event|PEG +Low-dose RBV + BOC for 48 Wks (Part II)|Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
10872589|NCT00423670|EG007|Reported Event|PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
10872590|NCT00423683|BG000|Baseline|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
10872591|NCT00423683|BG001|Baseline|1- Arixtra Alone|Arixtra treatment without inferior vena cava filter
10872592|NCT00423683|BG002|Baseline|Total|Total of all reporting groups
10872593|NCT00423683|FG000|Participant Flow|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
10872594|NCT00423683|FG001|Participant Flow|1-Arixtra Alone|Arixtra treatment without inferior vena cava filter
10872595|NCT00423683|OG000|Outcome|Arixtra|
10872596|NCT00423683|OG001|Outcome|Arixtra and Filter|
10872597|NCT00423683|OG000|Outcome|Arm 1 Arixtra|
10872598|NCT00423683|OG001|Outcome|Arm 2 Arixtra + IVC Filter|
10872599|NCT00423683|EG000|Reported Event|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
10872600|NCT00423683|EG001|Reported Event|Arixtra Alone|Arixtra anti coagulation alone
10872601|NCT00423722|BG000|Baseline|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872602|NCT00423722|BG001|Baseline|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872603|NCT00423722|BG002|Baseline|Total|Total of all reporting groups
10872604|NCT00423722|FG000|Participant Flow|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872605|NCT00423722|FG001|Participant Flow|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872606|NCT00423722|OG000|Outcome|Hydration|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872607|NCT00423722|OG001|Outcome|Placebo|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872608|NCT00423722|OG000|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872609|NCT00423722|OG001|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872610|NCT00423722|OG002|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872611|NCT00423722|OG003|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872612|NCT00423722|OG000|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872613|NCT00423722|OG001|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
10872614|NCT00423722|EG000|Reported Event|Hydration|Change Between Day 4 and Baseline
10872615|NCT00423722|EG001|Reported Event|Placebo|Change Between Day 4 and Baseline
10872616|NCT00423735|BG000|Baseline|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
10872617|NCT00423735|BG001|Baseline|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
10872618|NCT00423735|BG002|Baseline|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
10872619|NCT00423735|BG003|Baseline|Total|Total of all reporting groups
10872620|NCT00423735|FG000|Participant Flow|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
10872621|NCT00423735|FG001|Participant Flow|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
10872622|NCT00423735|FG002|Participant Flow|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
10872623|NCT00423735|OG000|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
10978115|NCT00948298|EG000|Reported Event|Placebo|Two tablets of oral placebo (microcrystalline cellulose), matching in appearance to the Vitamin D3, will be given every 4 weeks.
10872624|NCT00423735|OG001|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
10872625|NCT00423735|OG002|Outcome|Stage 2:|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity
10872626|NCT00423735|OG000|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
10872627|NCT00423735|OG000|Outcome|Stable Disease|"Patients with best response of stable disease by six months. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased."
10872628|NCT00423735|OG001|Outcome|Progressive Disease|"Patients with best tumor response of progressive disease by six months. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased."
10872629|NCT00423735|EG000|Reported Event|Stage 1: Dasatinib 200mg/Day|"Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity~dasatinib: Given orally"
10872630|NCT00423735|EG001|Reported Event|Stage 1B: Dasatinib up to 400mg/Day|"Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.~dasatinib: Given orally"
10872631|NCT00423800|BG000|Baseline|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
10872632|NCT00423800|BG001|Baseline|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
10872633|NCT00423800|BG002|Baseline|Total|Total of all reporting groups
10872634|NCT00423800|FG000|Participant Flow|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
10872635|NCT00423800|FG001|Participant Flow|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
10872636|NCT00423800|OG000|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
10872637|NCT00423800|OG001|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
10872638|NCT00423800|EG000|Reported Event|Screen Failures|Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here.
10872639|NCT00423800|EG001|Reported Event|Pegetron® - 24 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment.
10872640|NCT00423800|EG002|Reported Event|Pegetron® - 48 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment.
10872641|NCT00423813|BG000|Baseline|Placebo|Placebo taken as two equally divided nightly doses
10872642|NCT00423813|BG001|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
10872643|NCT00423813|BG002|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
10872644|NCT00423813|BG003|Baseline|Total|Total of all reporting groups
10872645|NCT00423813|FG000|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
10872646|NCT00423813|FG001|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
10872647|NCT00423813|FG002|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
10872648|NCT00423813|OG000|Outcome|Placebo|Placebo taken as two equally divided nightly doses
10872649|NCT00423813|OG001|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
10872650|NCT00423813|OG002|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
10872651|NCT00423813|EG000|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
10872652|NCT00423813|EG001|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
10872653|NCT00423813|EG002|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
10872654|NCT00423852|BG000|Baseline|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10872655|NCT00423852|FG000|Participant Flow|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10978116|NCT00948298|EG001|Reported Event|Vitamin D|Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
10978117|NCT00948389|BG000|Baseline|Dose Level 1A|Dasatinib: 100 mg once daily (QD) cycle 1 / 100 mg twice daily (BID) cycle 2 + lomustine (CCNU): 110 mg/m²
10978118|NCT00948389|BG001|Baseline|Dose Level 1B|Dasatinib: 100 mg QD / 100mg BID + CCNU: 90 mg/m²
10872656|NCT00423852|OG000|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10872657|NCT00423852|EG000|Reported Event|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10872658|NCT00423878|BG000|Baseline|Switch Group|Participants will switch to aripiprazole.
10872659|NCT00423878|BG001|Baseline|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
10872660|NCT00423878|BG002|Baseline|Total|Total of all reporting groups
10872661|NCT00423878|FG000|Participant Flow|Switch Group|Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day.
10872662|NCT00423878|FG001|Participant Flow|Stay Group|Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.
10872663|NCT00423878|OG000|Outcome|Switch Group|Participants will switch to aripiprazole.
10872664|NCT00423878|OG001|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
10872665|NCT00423878|EG000|Reported Event|Switch Group|Participants will switch to aripiprazole.
10872666|NCT00423878|EG001|Reported Event|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
10872667|NCT00423891|BG000|Baseline|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10978119|NCT00948389|BG002|Baseline|Dose Level 2|Dasatinib: 100 mg BID + CCNU: 90 mg/m²
10978120|NCT00948389|BG003|Baseline|Dose Level 3A|Dasatinib: 150 mg/day (100 mg AM and 50 mg PM) + CCNU: 90 mg/m²
10872668|NCT00423891|BG001|Baseline|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872669|NCT00423891|BG002|Baseline|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
10872670|NCT00423891|BG003|Baseline|Total|Total of all reporting groups
10872671|NCT00423891|FG000|Participant Flow|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872672|NCT00423891|FG001|Participant Flow|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872673|NCT00423891|FG002|Participant Flow|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
10978121|NCT00948389|BG004|Baseline|Dose Level 3B|Dasatinib: 100 mg/day (QD) + CCNU: 90 mg/m²
10978122|NCT00948389|BG005|Baseline|Total|Total of all reporting groups
10872674|NCT00423891|OG000|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872675|NCT00423891|OG001|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872676|NCT00423891|OG000|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872677|NCT00423891|OG001|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872678|NCT00423891|OG002|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
10872679|NCT00423891|EG000|Reported Event|Group A LVD-naive|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872680|NCT00423891|EG001|Reported Event|Group B LVD-exp|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
10872681|NCT00423891|EG002|Reported Event|Group C NA-exp|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
10872682|NCT00423917|BG000|Baseline|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10872683|NCT00423917|FG000|Participant Flow|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10978123|NCT00948389|FG000|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
10978124|NCT00948389|FG001|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2.
10978125|NCT00948389|FG002|Participant Flow|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
10978126|NCT00948389|FG003|Participant Flow|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
10978127|NCT00948389|FG004|Participant Flow|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
10978128|NCT00948389|OG000|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
10978129|NCT00948389|OG001|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
10978130|NCT00948389|OG002|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
10978131|NCT00948389|OG003|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
10978132|NCT00948389|OG004|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
10978133|NCT00948389|OG004|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
10978134|NCT00948389|OG000|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2
10978135|NCT00948389|EG000|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
10978136|NCT00948389|EG001|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
10978137|NCT00948389|EG002|Reported Event|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
10978138|NCT00948389|EG003|Reported Event|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
10978139|NCT00948389|EG004|Reported Event|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
10978140|NCT00948428|BG000|Baseline|Generic Imiquimod|"Imiquimod cream, 5%~Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978141|NCT00948428|BG001|Baseline|Aldara™|"Aldara™ (imiquimod) cream, 5%~Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978142|NCT00948428|BG002|Baseline|Vehicle Cream|"Vehicle cream (Actavis)~Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978143|NCT00948428|BG003|Baseline|Total|Total of all reporting groups
10978144|NCT00948428|FG000|Participant Flow|Generic Imiquimod|"Imiquimod cream, 5%~Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978145|NCT00948428|FG001|Participant Flow|Aldara™|"Aldara™ (imiquimod) cream, 5%~Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978146|NCT00948428|FG002|Participant Flow|Vehicle Cream|"Vehicle cream (Actavis)~Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978147|NCT00948428|OG000|Outcome|Generic Imiquimod|"Imiquimod cream, 5%~Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978148|NCT00948428|OG001|Outcome|Aldara™|"Aldara™ (imiquimod) cream, 5%~Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978149|NCT00948428|OG002|Outcome|Vehicle Cream|"Vehicle cream (Actavis)~Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978150|NCT00948428|EG000|Reported Event|Generic Imiquimod|"Imiquimod cream, 5%~Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978151|NCT00948428|EG001|Reported Event|Aldara™|"Aldara™ (imiquimod) cream, 5%~Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978152|NCT00948428|EG002|Reported Event|Vehicle Cream|"Vehicle cream (Actavis)~Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks"
10978153|NCT00948441|BG000|Baseline|Group 1|25% ethanol x12 weeks; washout x4 weeks; heparin x12 weeks
10978154|NCT00948441|BG001|Baseline|Group 2|Heparin x12 weeks; washout x4 weeks; 25% ethanol x 12 weeks
10978155|NCT00948441|BG002|Baseline|Total|Total of all reporting groups
10978156|NCT00948441|FG000|Participant Flow|25% Ethanol/Washout/Heparin|First 25% ethanol, then Washout, then heparin
10978157|NCT00948441|FG001|Participant Flow|Heparin Lock/Washout/25% Ethanol|First Heparin lock, then washout period, then 25% ethanol lock
10978158|NCT00948441|OG000|Outcome|Infections While Using Ethanol Lock|"25% ethanol x 12 weeks~25% ethanol: Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
10978159|NCT00948441|OG001|Outcome|Infections While Using Heparin Lock|"Heparin lock x 12 weeks~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution was instilled and allowed to dwell for 4 to 12 hours."
10978160|NCT00948441|OG000|Outcome|Ethanol Lock|"25% ethanol~25% ethanol: Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
10978161|NCT00948441|OG001|Outcome|Heparin Lock|"Heparin~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
10872684|NCT00423917|OG000|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10872685|NCT00423917|EG000|Reported Event|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10872686|NCT00423930|BG000|Baseline|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
10872687|NCT00423930|FG000|Participant Flow|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
10872688|NCT00423930|OG000|Outcome|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
10872689|NCT00423930|EG000|Reported Event|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
10872690|NCT00423943|BG000|Baseline|Drug|"modafinil~modafinil: 200 milligrams daily dose"
10872691|NCT00423943|BG001|Baseline|Placebo|"placebo~modafinil: 200 milligrams daily dose"
10872692|NCT00423943|BG002|Baseline|Total|Total of all reporting groups
10872693|NCT00423943|FG000|Participant Flow|Drug|"modafinil~modafinil: 200 milligrams daily dose"
10872694|NCT00423943|FG001|Participant Flow|Placebo|"placebo~modafinil: 200 milligrams daily dose"
10872695|NCT00423943|OG000|Outcome|Drug|"modafinil~modafinil: 200 milligrams daily dose"
10872696|NCT00423943|OG001|Outcome|Placebo|"placebo~modafinil: 200 milligrams daily dose"
10978162|NCT00948441|EG000|Reported Event|Ethanol Lock|"25% ethanol~25% ethanol: Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
10872697|NCT00423943|EG000|Reported Event|Drug|"modafinil~modafinil: 200 milligrams daily dose"
10872698|NCT00423943|EG001|Reported Event|Placebo|"placebo~modafinil: 200 milligrams daily dose"
10872699|NCT00424021|BG000|Baseline|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872700|NCT00424021|BG001|Baseline|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872701|NCT00424021|BG002|Baseline|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872702|NCT00424021|BG003|Baseline|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872703|NCT00424021|BG004|Baseline|Total|Total of all reporting groups
10872704|NCT00424021|FG000|Participant Flow|1 mg|The optimized final dose from the open-label period of AMB 220 (given once daily [QD] by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872705|NCT00424021|FG001|Participant Flow|2.5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872706|NCT00424021|FG002|Participant Flow|5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872707|NCT00424021|FG003|Participant Flow|10 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872708|NCT00424021|OG000|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10978163|NCT00948441|EG001|Reported Event|Heparin Lock|"Heparin~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
10978164|NCT00948506|BG000|Baseline|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
10978165|NCT00948506|BG001|Baseline|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
10978166|NCT00948506|BG002|Baseline|Total|Total of all reporting groups
10978167|NCT00948506|FG000|Participant Flow|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
10978168|NCT00948506|FG001|Participant Flow|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
10978169|NCT00948506|OG000|Outcome|1% Cidofovir|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
10978170|NCT00948506|OG001|Outcome|3% Cidofovir|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
10978171|NCT00948506|OG002|Outcome|Placebo|Subjects received placebo to one side of the face in a split-face design (1% or 3% cidofovir was applied to the other side of the face).
10978172|NCT00948506|OG000|Outcome|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
10978173|NCT00948506|OG001|Outcome|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
10978174|NCT00948506|EG000|Reported Event|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
10978175|NCT00948506|EG001|Reported Event|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
10978176|NCT00948610|BG000|Baseline|Placebo|"Placebo-participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
10978177|NCT00948610|BG001|Baseline|Remicade|"Remicade-Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
10978178|NCT00948610|BG002|Baseline|Total|Total of all reporting groups
10978179|NCT00948610|FG000|Participant Flow|Placebo|"Placebo-participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
10978180|NCT00948610|FG001|Participant Flow|Remicade|"Remicade-Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
10978181|NCT00948610|OG000|Outcome|Placebo|"Placebo-participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
10978182|NCT00948610|OG001|Outcome|Remicade|"Remicade-Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
10978183|NCT00948610|EG000|Reported Event|Placebo|"Placebo-participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
10978184|NCT00948610|EG001|Reported Event|Remicade|"Remicade-Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
10978185|NCT00948675|BG000|Baseline|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
10978186|NCT00948675|BG001|Baseline|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
10978187|NCT00948675|BG002|Baseline|Total|Total of all reporting groups
10978188|NCT00948675|FG000|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
10978189|NCT00948675|FG001|Participant Flow|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
10978190|NCT00948675|OG000|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
10978191|NCT00948675|OG001|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
10978192|NCT00948675|EG000|Reported Event|Pemetrexed + Carboplatin|Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles. Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
10978193|NCT00948675|EG001|Reported Event|Paclitaxel + Carboplatin + Bevacizumab|Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/ kg) given intravenously for four 21-day cycles. Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
10978194|NCT00948688|BG000|Baseline|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
10978195|NCT00948688|FG000|Participant Flow|Vorinostat 200 mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
10978196|NCT00948688|FG001|Participant Flow|Vorinostat 100 mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
10978197|NCT00948688|OG000|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
10978198|NCT00948688|OG000|Outcome|Vorinostat 200 mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
10978199|NCT00948688|OG001|Outcome|Vorinostat 100 mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
10978200|NCT00948688|EG000|Reported Event|Vorinostat 200mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)during each week of radiation therapy
10978201|NCT00948688|EG001|Reported Event|Vorinostat 100mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
10978202|NCT00948766|BG000|Baseline|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
10978203|NCT00948766|BG001|Baseline|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
10978204|NCT00948766|BG002|Baseline|Total|Total of all reporting groups
10978205|NCT00948766|FG000|Participant Flow|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
10978206|NCT00948766|FG001|Participant Flow|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
10978207|NCT00948766|OG000|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
10978208|NCT00948766|OG001|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
10978209|NCT00948766|EG000|Reported Event|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
10978210|NCT00948766|EG001|Reported Event|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
10978211|NCT00948766|EG002|Reported Event|Extension Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
10978212|NCT00948792|BG000|Baseline|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or two hours (long).
10978213|NCT00948792|FG000|Participant Flow|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or 2 hours (long).
10978214|NCT00948792|OG000|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
10978215|NCT00948792|OG001|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
10978216|NCT00948792|EG000|Reported Event|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
10978217|NCT00948792|EG001|Reported Event|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
10978218|NCT00948818|BG000|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
10978219|NCT00948818|BG001|Baseline|Linaclotide|Linaclotide 290µg, oral administration, once per day.
10978220|NCT00948818|BG002|Baseline|Total|Total of all reporting groups
10978221|NCT00948818|FG000|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
10978222|NCT00948818|FG001|Participant Flow|Linaclotide|Linaclotide 290µg, oral administration, once per day.
10978223|NCT00948818|OG000|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
10978224|NCT00948818|OG001|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
10978225|NCT00948818|EG000|Reported Event|Placebo - Treatment Period|Dose-matched placebo, oral administration, once per day.
10978226|NCT00948818|EG001|Reported Event|Linaclotide - Treatment Period|Linaclotide 290µg, oral administration, once per day.
10978227|NCT00948818|EG002|Reported Event|Placebo to Linaclotide - Randomized Withdrawal Period|"Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period.~This group had previously received dose-matched placebo during the 12-week randomized treatment period."
10978228|NCT00948818|EG003|Reported Event|Linaclotide to Placebo - Randomized Withdrawal Period|"Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period.~This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period."
10978229|NCT00948818|EG004|Reported Event|Linaclotide to Linaclotide - Randomized Withdrawal Period|Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period
10978230|NCT00948857|BG000|Baseline|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
10978231|NCT00948857|BG001|Baseline|Blinded Placebo|Blinded placebo
10978232|NCT00948857|BG002|Baseline|Total|Total of all reporting groups
10978233|NCT00948857|FG000|Participant Flow|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
10978234|NCT00948857|FG001|Participant Flow|Blinded Placebo|Blinded placebo
10978235|NCT00948857|OG000|Outcome|DHEA|Dehydroepiandrosterone 25 mg tid po
10978236|NCT00948857|OG001|Outcome|Placebo|Blinded placebo
10978237|NCT00948857|EG000|Reported Event|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
10978238|NCT00948857|EG001|Reported Event|Blinded Placebo|Blinded placebo
10978239|NCT00948896|BG000|Baseline|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
10978240|NCT00948896|BG001|Baseline|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10978241|NCT00948896|BG002|Baseline|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978242|NCT00948896|BG003|Baseline|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10978243|NCT00948896|BG004|Baseline|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
10978244|NCT00948896|BG005|Baseline|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10978245|NCT00948896|BG006|Baseline|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978246|NCT00948896|BG007|Baseline|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10978247|NCT00948896|BG008|Baseline|Total|Total of all reporting groups
10978248|NCT00948896|FG000|Participant Flow|HIV-unexposed & No Chemoprevention|HIV-unexposed No chemoprevention was given
10978249|NCT00948896|FG001|Participant Flow|HIV-unexposed & SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10978250|NCT00948896|FG002|Participant Flow|HIV-unexposed & TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978251|NCT00948896|FG003|Participant Flow|HIV-unexposed & DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10978252|NCT00948896|FG004|Participant Flow|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
10978253|NCT00948896|FG005|Participant Flow|HIV-exposed & SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10978254|NCT00948896|FG006|Participant Flow|HIV-exposed & TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978255|NCT00948896|FG007|Participant Flow|HIV-exposed & DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10978256|NCT00948896|OG000|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
10978257|NCT00948896|OG001|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10978258|NCT00948896|OG002|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978259|NCT00948896|OG003|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10978260|NCT00948896|OG004|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
10978261|NCT00948896|OG005|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10978262|NCT00948896|OG006|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978263|NCT00948896|OG007|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10978264|NCT00948896|OG000|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
10978265|NCT00948896|OG001|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10872709|NCT00424021|OG001|Outcome|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872710|NCT00424021|OG002|Outcome|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872711|NCT00424021|OG003|Outcome|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872712|NCT00424021|OG000|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
10872713|NCT00424021|OG000|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
10872714|NCT00424021|OG000|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
10872715|NCT00424021|OG000|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872716|NCT00424021|OG001|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872717|NCT00424021|OG002|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872718|NCT00424021|OG003|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872719|NCT00424021|EG000|Reported Event|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872720|NCT00424021|EG001|Reported Event|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
10872721|NCT00424021|EG002|Reported Event|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872722|NCT00424021|EG003|Reported Event|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
10872723|NCT00424047|BG000|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
10872724|NCT00424047|BG001|Baseline|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
10872725|NCT00424047|BG002|Baseline|Total|Total of all reporting groups
10872726|NCT00424047|FG000|Participant Flow|Lenalidomide Plus Dexamethasone (Len/Dex)|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
10872727|NCT00424047|FG001|Participant Flow|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
10978266|NCT00948896|OG002|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978267|NCT00948896|OG003|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10872728|NCT00424047|OG000|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
10872729|NCT00424047|OG001|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
10872730|NCT00424047|OG001|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
10872731|NCT00424047|OG000|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
10872732|NCT00424047|OG001|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
10872733|NCT00424047|OG001|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
10872734|NCT00424047|OG001|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
10872735|NCT00424047|EG000|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
10872736|NCT00424047|EG001|Reported Event|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
10872737|NCT00424177|BG000|Baseline|Overall Study Population|Male and female participants greater than or equal to 18 years of age with previously treated chronic ITP, as defined according to the American Society of Hematology/British Committee for Standards in Hematology guidelines, who had platelet counts between greater than or equal to 20 gi/L and less than or equal to 50 Gi/L, on the Day 1 visit (or within 24 hours prior to dosing on Day 1).
10872738|NCT00424177|FG000|Participant Flow|Treatment Period|Three cycles of treatment. A cycle is defined as an on-therapy period of up to 6 weeks and an off-therapy period of up to 4 weeks.
10872739|NCT00424177|OG000|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
10872740|NCT00424177|OG001|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
10872741|NCT00424177|OG002|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
10872742|NCT00424177|OG000|Outcome|Overall Study|
10872743|NCT00424177|EG000|Reported Event|Cycle 1|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
10872744|NCT00424177|EG001|Reported Event|Cycle 2|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
10872745|NCT00424177|EG002|Reported Event|Cycle 3|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
10872746|NCT00424177|EG003|Reported Event|More Than 1 to 30 Days After Last Dose|Adverse events >1 to 30 days after last dose (Post-therapy)
10872747|NCT00424177|EG004|Reported Event|More Than 30 Days After Last Dose|Adverse events >30 days after last dose (Post-therapy)
10872748|NCT00424177|EG005|Reported Event|All Cycles|Participants who reported an AE anytime during 3 cycles of treatment. A cycle consisted of once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy.
10872749|NCT00424190|BG000|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
10872750|NCT00424190|BG001|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
10872751|NCT00424190|BG002|Baseline|Total|Total of all reporting groups
10872752|NCT00424190|FG000|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
10872753|NCT00424190|FG001|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
10872754|NCT00424190|OG000|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
10872755|NCT00424190|OG001|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
10872756|NCT00424190|EG000|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
10872757|NCT00424190|EG001|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
10872758|NCT00424255|BG000|Baseline|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
10872759|NCT00424255|BG001|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
10872760|NCT00424255|BG002|Baseline|Total|Total of all reporting groups
10872761|NCT00424255|FG000|Participant Flow|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
10872762|NCT00424255|FG001|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
10872763|NCT00424255|OG000|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
10872764|NCT00424255|OG001|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
10872765|NCT00424255|EG000|Reported Event|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
10872766|NCT00424255|EG001|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
10872767|NCT00424268|BG000|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
10872768|NCT00424268|BG001|Baseline|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
10872769|NCT00424268|BG002|Baseline|Total|Total of all reporting groups
10872770|NCT00424268|FG000|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
10872771|NCT00424268|FG001|Participant Flow|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
10872772|NCT00424268|OG000|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
10872773|NCT00424268|OG001|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
10978268|NCT00948896|EG000|Reported Event|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
10978269|NCT00948896|EG001|Reported Event|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10978270|NCT00948896|EG002|Reported Event|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978271|NCT00948896|EG003|Reported Event|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10978272|NCT00948896|EG004|Reported Event|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
10978273|NCT00948896|EG005|Reported Event|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
10978274|NCT00948896|EG006|Reported Event|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
10978275|NCT00948896|EG007|Reported Event|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
10978276|NCT00948922|BG000|Baseline|A: Allogeneic Stem Cell Transplant|Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
10978277|NCT00948922|BG001|Baseline|B: Autologous Stem Cell Transplant|Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
10978278|NCT00948922|BG002|Baseline|BE: Group B Expansion|Group B Expansion on Bortezomib Maintenance: Autologous Only.
10978279|NCT00948922|BG003|Baseline|Total|Total of all reporting groups
10978280|NCT00948922|FG000|Participant Flow|A: Allogeneic Stem Cell Transplant|"Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.~Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).~Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes.~Fludarabine: Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV~Allogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with granulocyte colony-stimulating factor (GCSF) mobilization and infused fresh to recipients. Allogeneic donor stem cells may be cryopreserved if they cannot be infused"
10978281|NCT00948922|FG001|Participant Flow|B: Autologous Stem Cell Transplant|"Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.~Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).~Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes.~Autologous Stem Cell Transplant: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (G-CSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells."
10978282|NCT00948922|FG002|Participant Flow|BE: Group B Expansion|"Group B Expansion on Bortezomib Maintenance: Autologous Only.~Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).~Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes.~Autologous Stem Cell Transplant: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (G-CSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells."
10978283|NCT00948922|OG000|Outcome|A: Allogeneic Stem Cell Transplant|Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
10978284|NCT00948922|OG001|Outcome|B: Autologous Stem Cell Transplant|Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
10978285|NCT00948922|OG002|Outcome|BE: Group B Expansion|Group B Expansion on Bortezomib Maintenance: Autologous Only.
10978286|NCT00948922|OG000|Outcome|A: Allogeneic Stem Cell Transplant|"Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.~Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).~Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes.~Fludarabine: Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV~Allogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with granulocyte colony-stimulating factor (GCSF) mobilization and infused fresh to recipients. Allogeneic donor stem cells may be cryopreserved if they cannot be infused"
10978287|NCT00948922|OG001|Outcome|B: Autologous Stem Cell Transplant|"Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.~Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).~Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes.~Autologous Stem Cell Transplant: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (G-CSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells."
10872774|NCT00424268|EG000|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
10872775|NCT00424268|EG001|Reported Event|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
10872776|NCT00424294|BG000|Baseline|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
10872777|NCT00424294|BG001|Baseline|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
10872778|NCT00424294|BG002|Baseline|Total|Total of all reporting groups
10872779|NCT00424294|FG000|Participant Flow|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
10872780|NCT00424294|FG001|Participant Flow|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
10872781|NCT00424294|OG000|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
10872782|NCT00424294|OG001|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
10872783|NCT00424294|EG000|Reported Event|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
10872784|NCT00424294|EG001|Reported Event|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
10978288|NCT00948922|OG002|Outcome|BE: Group B Expansion|"Group B Expansion on Bortezomib Maintenance: Autologous Only.~Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).~Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes.~Autologous Stem Cell Transplant: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (G-CSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells."
10978289|NCT00948922|OG000|Outcome|A: Allogenic Stem Cell Transplant|Allogenic Stem Cell Transplant: Fludarabine + Melphalan + Bortezomib followed by Allogenic Rescue
10978290|NCT00948922|EG000|Reported Event|A: Allogeneic Stem Cell Transplant|Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
10978291|NCT00948922|EG001|Reported Event|B: Autologous Stem Cell Transplant|Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
10978292|NCT00948922|EG002|Reported Event|BE: Group B Expansion|Group B Expansion on Bortezomib Maintenance: Autologous Only.
10978293|NCT00948935|BG000|Baseline|Chemotherapy|"Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.~Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities."
10872785|NCT00424346|BG000|Baseline|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
10872786|NCT00424346|BG001|Baseline|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872787|NCT00424346|BG002|Baseline|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872788|NCT00424346|BG003|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872789|NCT00424346|BG004|Baseline|Total|Total of all reporting groups
10879280|NCT00456599|EG000|Reported Event|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
10872790|NCT00424346|FG000|Participant Flow|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks. Participants in this treatment group who participated in the Extension Phase are represented in the 'Canakinumab 300 mg q2wk' treatment group in the Extension Phase table below.
10872791|NCT00424346|FG001|Participant Flow|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872792|NCT00424346|FG002|Participant Flow|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872793|NCT00424346|FG003|Participant Flow|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872794|NCT00424346|OG000|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
10872795|NCT00424346|OG001|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872796|NCT00424346|OG002|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872797|NCT00424346|OG003|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872798|NCT00424346|OG000|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
10872799|NCT00424346|OG001|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872800|NCT00424346|OG002|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
10872801|NCT00424346|EG000|Reported Event|ACZ885 600mg iv + 300mg sc q2wk|ACZ885 600mg iv + 300mg sc q2wk
10872802|NCT00424346|EG001|Reported Event|ACZ885 300mg sc q2wk|ACZ885 300mg sc q2wk
10872803|NCT00424346|EG002|Reported Event|ACZ885 150mg sc q4wk|ACZ885 150mg sc q4wk
10872804|NCT00424346|EG003|Reported Event|Placebo|Placebo
10872805|NCT00424372|BG000|Baseline|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
10872806|NCT00424372|FG000|Participant Flow|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
10872807|NCT00424372|OG000|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
10872808|NCT00424372|EG000|Reported Event|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
10872809|NCT00424385|BG000|Baseline|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
10872810|NCT00424385|FG000|Participant Flow|Imatinib + Sorafenib|"Both drugs, Gleevec + Sorafenib are given to all patients on study. There are 4 potential cohorts. Each will enroll 3 evaluable (patients that complete 2 cycles of treatment) patients. If a Dose Limiting Toxicity is demonstrated in a cohort, an additional 3 evaluable patients can be enrolled in that cohort.~Cohort 0 was 400mg Sorafenib every day (QD)and 300mg of Imatinib QD. Cohort 1 was 400mg Sorafenib two times a day and 300mg QD Imatinib."
10872811|NCT00424385|OG000|Outcome|Imatinib + Sorafenib Cohort 0|300mg every day (QD)Imatinib + 400mg every day (QD) Sorafenib, by mouth
10872812|NCT00424385|OG001|Outcome|Imatinib + Sorafenib Cohort 1|300mg every day (QD) Imatinib + 400mg twice daily (BID)Sorafenib, by mouth
10872813|NCT00424385|OG000|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
10872814|NCT00424385|EG000|Reported Event|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
10872815|NCT00424398|BG000|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872816|NCT00424398|BG001|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872817|NCT00424398|BG002|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872818|NCT00424398|BG003|Baseline|Total|Total of all reporting groups
10872819|NCT00424398|FG000|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872820|NCT00424398|FG001|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872821|NCT00424398|FG002|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872822|NCT00424398|OG000|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872823|NCT00424398|OG001|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872824|NCT00424398|OG002|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872825|NCT00424398|EG000|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872826|NCT00424398|EG001|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872827|NCT00424398|EG002|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10872828|NCT00424463|BG000|Baseline|MCI-186 - Placebo of MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872829|NCT00424463|BG001|Baseline|MCI-186 - MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872830|NCT00424463|BG002|Baseline|Placebo of MCI-186 - MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872831|NCT00424463|BG003|Baseline|Total|Total of all reporting groups
10872832|NCT00424463|FG000|Participant Flow|MCI-186 - Placebo of MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872833|NCT00424463|FG001|Participant Flow|MCI-186 - MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872834|NCT00424463|FG002|Participant Flow|Placebo of MCI-186 - MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872835|NCT00424463|OG000|Outcome|MCI-186 - Placebo of MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872836|NCT00424463|OG001|Outcome|MCI-186 - MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872837|NCT00424463|OG002|Outcome|Placebo of MCI-186 - MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872838|NCT00424463|EG000|Reported Event|MCI-186 - Placebo of MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872839|NCT00424463|EG001|Reported Event|MCI-186 - MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10872840|NCT00424463|EG002|Reported Event|Placebo of MCI-186 - MCI-186|Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion
10978294|NCT00948935|FG000|Participant Flow|Chemotherapy|"Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.~Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities."
10978295|NCT00948935|OG000|Outcome|Chemotherapy|"Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.~Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities."
10978296|NCT00948935|EG000|Reported Event|Chemotherapy|"Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.~Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities."
10978297|NCT00948974|BG000|Baseline|Cognitive Therapy|"cognitive therapy and exposure~Cognitive Therapy: Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., if I attempt to initiate a conversation I'll humiliate myself), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005)."
10978298|NCT00948974|BG001|Baseline|Acceptance and Committment Therapy|"acceptance and commitment therapy and exposure~Acceptance and Commitment Therapy: ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009)."
10978299|NCT00948974|BG002|Baseline|Total|Total of all reporting groups
10978300|NCT00948974|FG000|Participant Flow|Cognitive Therapy|"cognitive therapy and exposure~Cognitive Therapy: Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., if I attempt to initiate a conversation I'll humiliate myself), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005)."
10978301|NCT00948974|FG001|Participant Flow|Acceptance and Committment Therapy|"acceptance and commitment therapy and exposure~Acceptance and Commitment Therapy: ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009)."
10978302|NCT00948974|OG000|Outcome|Cognitive Therapy|"cognitive therapy and exposure~Cognitive Therapy: Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., if I attempt to initiate a conversation I'll humiliate myself), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005)."
10978303|NCT00948974|OG001|Outcome|Acceptance and Committment Therapy|"acceptance and commitment therapy and exposure~Acceptance and Commitment Therapy: ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009)."
10978304|NCT00948974|EG000|Reported Event|Cognitive Therapy|"cognitive therapy and exposure~Cognitive Therapy: Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., if I attempt to initiate a conversation I'll humiliate myself), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005)."
11007046|NCT01089127|OG004|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
10872841|NCT00424476|BG000|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872842|NCT00424476|BG001|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872843|NCT00424476|BG002|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872844|NCT00424476|BG003|Baseline|Total|Total of all reporting groups
10872845|NCT00424476|FG000|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872846|NCT00424476|FG001|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872847|NCT00424476|FG002|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872848|NCT00424476|OG000|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872849|NCT00424476|OG001|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872850|NCT00424476|OG002|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872851|NCT00424476|EG000|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872852|NCT00424476|EG001|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872853|NCT00424476|EG002|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
10872854|NCT00424489|BG000|Baseline|Hematopoietic Stem Cell Transplantation|"Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning~Hematopoietic Stem Cell Transplantation: Autologous Hematopoietic Stem Cell Transplantation"
10872855|NCT00424489|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|"Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning~Hematopoietic Stem Cell Transplantation: Autologous Hematopoietic Stem Cell Transplantation"
10872856|NCT00424489|OG000|Outcome|Hematopoietic Stem Cell Transplantation|"Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning~Hematopoietic Stem Cell Transplantation: Autologous Hematopoietic Stem Cell Transplantation"
10872857|NCT00424489|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|"Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning~Hematopoietic Stem Cell Transplantation: Autologous Hematopoietic Stem Cell Transplantation"
10872858|NCT00424502|BG000|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
10872859|NCT00424502|FG000|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) and methylprednisolone 100 mg IV on Days 0 and 14.
10872860|NCT00424502|OG000|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
10872861|NCT00424502|EG000|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
10872862|NCT00424515|BG000|Baseline|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
10872863|NCT00424515|BG001|Baseline|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
10872864|NCT00424515|BG002|Baseline|Total|Total of all reporting groups
10872865|NCT00424515|FG000|Participant Flow|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
10872866|NCT00424515|FG001|Participant Flow|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
10872867|NCT00424515|OG000|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
10872868|NCT00424515|OG001|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
10872869|NCT00424515|EG000|Reported Event|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
10879281|NCT00456625|BG000|Baseline|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
10872870|NCT00424515|EG001|Reported Event|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
10872871|NCT00424528|BG000|Baseline|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
10872872|NCT00424528|BG001|Baseline|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
10872873|NCT00424528|BG002|Baseline|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
10872874|NCT00424528|BG003|Baseline|Total|Total of all reporting groups
10872875|NCT00424528|FG000|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
10872876|NCT00424528|FG001|Participant Flow|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
10872877|NCT00424528|FG002|Participant Flow|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
10872878|NCT00424528|OG000|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
10872879|NCT00424528|OG001|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
10872880|NCT00424528|OG002|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
10872881|NCT00424528|EG000|Reported Event|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
10872882|NCT00424528|EG001|Reported Event|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
10872883|NCT00424528|EG002|Reported Event|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
10872884|NCT00424554|BG000|Baseline|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
10872885|NCT00424554|BG001|Baseline|No Intervention|No pre-surgery treatment with temozolomide
10872886|NCT00424554|BG002|Baseline|Total|Total of all reporting groups
10872887|NCT00424554|FG000|Participant Flow|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
10872888|NCT00424554|FG001|Participant Flow|No Intervention|No pre-surgery treatment with temozolomide
10872889|NCT00424554|OG000|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
10872890|NCT00424554|OG001|Outcome|No Intervention|No pre-surgery treatment with temozolomide
10872891|NCT00424554|EG000|Reported Event|Temozolomide|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
10872892|NCT00424554|EG001|Reported Event|No Intervention|No pre-surgery treatment with temozolomide
10872893|NCT00424593|BG000|Baseline|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
10872894|NCT00424593|BG001|Baseline|Placebo|every day (QD), by mouth (PO), 13 weeks
10872895|NCT00424593|BG002|Baseline|Total|Total of all reporting groups
10872896|NCT00424593|FG000|Participant Flow|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
10872897|NCT00424593|FG001|Participant Flow|Placebo|every day (QD), by mouth (PO), 13 weeks
10872898|NCT00424593|OG000|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
10872899|NCT00424593|OG001|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
10872900|NCT00424593|EG000|Reported Event|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
10872901|NCT00424593|EG001|Reported Event|Placebo|every day (QD), by mouth (PO), 13 weeks
10872902|NCT00424619|BG000|Baseline|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
10872903|NCT00424619|BG001|Baseline|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
10872904|NCT00424619|BG002|Baseline|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
10872905|NCT00424619|BG003|Baseline|Total|Total of all reporting groups
10872906|NCT00424619|FG000|Participant Flow|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
10872907|NCT00424619|FG001|Participant Flow|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
10872908|NCT00424619|FG002|Participant Flow|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
10872909|NCT00424619|OG000|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
10872910|NCT00424619|OG001|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
10872911|NCT00424619|OG002|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
10872912|NCT00424619|EG000|Reported Event|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
10872913|NCT00424619|EG001|Reported Event|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
10872914|NCT00424619|EG002|Reported Event|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
10872915|NCT00424632|BG000|Baseline|PF-03814735 (Schedule A)|Participants received daily dosing of PF-03814735 of 5, 10, 20, 40, 60, 80, or 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872916|NCT00424632|BG001|Baseline|PF-03814735 (Schedule B)|Participants received daily dosing of PF-03814735 of 40, 50, or 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872917|NCT00424632|BG002|Baseline|Total|Total of all reporting groups
10872918|NCT00424632|FG000|Participant Flow|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872919|NCT00424632|FG001|Participant Flow|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872920|NCT00424632|FG002|Participant Flow|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872921|NCT00424632|FG003|Participant Flow|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872922|NCT00424632|FG004|Participant Flow|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872923|NCT00424632|FG005|Participant Flow|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872924|NCT00424632|FG006|Participant Flow|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872925|NCT00424632|FG007|Participant Flow|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872926|NCT00424632|FG008|Participant Flow|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872927|NCT00424632|FG009|Participant Flow|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872928|NCT00424632|OG000|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872929|NCT00424632|OG001|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872930|NCT00424632|OG002|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872931|NCT00424632|OG003|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872932|NCT00424632|OG004|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872933|NCT00424632|OG005|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872934|NCT00424632|OG006|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872935|NCT00424632|OG007|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872936|NCT00424632|OG008|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872937|NCT00424632|OG009|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872938|NCT00424632|OG007|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
10872939|NCT00424632|OG008|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872940|NCT00424632|OG009|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872941|NCT00424632|OG010|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10978305|NCT00948974|EG001|Reported Event|Acceptance and Committment Therapy|"acceptance and commitment therapy and exposure~Acceptance and Commitment Therapy: ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009)."
10978306|NCT00949078|BG000|Baseline|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
10978307|NCT00949078|BG001|Baseline|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
10978308|NCT00949078|BG002|Baseline|Total|Total of all reporting groups
10978309|NCT00949078|FG000|Participant Flow|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
10978310|NCT00949078|FG001|Participant Flow|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
10978311|NCT00949078|OG000|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
10978312|NCT00949078|OG001|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
10978313|NCT00949078|EG000|Reported Event|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
10978314|NCT00949078|EG001|Reported Event|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
10978315|NCT00949117|BG000|Baseline|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
10978316|NCT00949117|BG001|Baseline|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
10978317|NCT00949117|BG002|Baseline|Total|Total of all reporting groups
10978318|NCT00949117|FG000|Participant Flow|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
10978319|NCT00949117|FG001|Participant Flow|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
10978320|NCT00949117|OG000|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
10978321|NCT00949117|OG001|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
10978322|NCT00949117|OG000|Outcome|Arm I- Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.~cyproheptadine hydrochloride: Given orally"
10978323|NCT00949117|OG001|Outcome|Cyproheptadine HCl & PediaSure or Ensure|"Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.~Ensure: Given orally~PediaSure: Given orally~cyproheptadine hydrochloride: Given orally"
10872942|NCT00424632|OG007|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
10872943|NCT00424632|OG000|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872944|NCT00424632|OG001|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872945|NCT00424632|OG002|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872946|NCT00424632|OG000|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872947|NCT00424632|EG000|Reported Event|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872948|NCT00424632|EG001|Reported Event|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872949|NCT00424632|EG002|Reported Event|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872950|NCT00424632|EG003|Reported Event|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872951|NCT00424632|EG004|Reported Event|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872952|NCT00424632|EG005|Reported Event|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872953|NCT00424632|EG006|Reported Event|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
10872954|NCT00424632|EG007|Reported Event|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872955|NCT00424632|EG008|Reported Event|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872956|NCT00424632|EG009|Reported Event|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
10872957|NCT00424749|BG000|Baseline|Rituximab|375 mg/m^2/week for 4 weeks
10872958|NCT00424749|FG000|Participant Flow|Rituximab|375 mg/m^2/week for 4 weeks
10872959|NCT00424749|OG000|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
10872960|NCT00424749|EG000|Reported Event|Rituximab|375 mg/m^2/week for 4 weeks
10872961|NCT00424762|BG000|Baseline|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
10872962|NCT00424762|BG001|Baseline|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
10872963|NCT00424762|BG002|Baseline|Total|Total of all reporting groups
10872964|NCT00424762|FG000|Participant Flow|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
10872965|NCT00424762|FG001|Participant Flow|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
10872966|NCT00424762|OG000|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
10872967|NCT00424762|OG001|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
10872968|NCT00424762|EG000|Reported Event|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
10872969|NCT00424762|EG001|Reported Event|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
10872970|NCT00424775|BG000|Baseline|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
10879282|NCT00456625|FG000|Participant Flow|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
10872971|NCT00424775|FG000|Participant Flow|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
10872972|NCT00424775|FG001|Participant Flow|Vorinostat (400 mg)|This group includes data from all participants who are treated with vorinostat 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. However, no participants received vorinostat 400 mg once daily due to early discontinuation of the study based on the dose limited toxicity on vorinostat 300 mg once daily.
10872973|NCT00424775|OG000|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
10872974|NCT00424775|EG000|Reported Event|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
10872975|NCT00424827|BG000|Baseline|This Was a Prospective, Single Arm, Open Label Pilot Phase II|"A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil, and Radiation Therapy in Locally Advanced Nonmetastatic Pancreatic Adenocarcinoma~This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.~Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases. The purpose of this study is to evaluate the efficacy and safety of cetuximab in combination with gemcitabine and 5-FU along with radiation therapy in locally advanced non-resectable, pancreatic adenocarcinoma, using progression free survival as the primary end point."
10872976|NCT00424827|FG000|Participant Flow|Single Arm|"This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.~Gemcitabine/Fluorouracil with External Beam Radiation: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma."
10872977|NCT00424827|OG000|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|Progression-free survival
10872978|NCT00424827|OG000|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
10872979|NCT00424827|EG000|Reported Event|Gemcitabine/Fluorouracil With External Beam Radiation|antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
10872980|NCT00424840|BG000|Baseline|Phase I: Dose Level 1, 2 and 3|"1.3 mg/m^2 Bortezomib, 1.6 mg/m^2 Bortezomib, and 1.8 mg/m^2 Bortezomib~In phase I, three dose levels of weekly bortezomib will be studied in conjunction with fixed dose carboplatin and bevacizumab on a 21 day cycle to define the maximum tolerated dose (MTD)."
10872981|NCT00424840|FG000|Participant Flow|Dose Level 1: 1.3 mg/m^2 Bortezomib|Level 1 participants were given 1.3 mg/m^2 Bortezomib with Carboplatin AUC6, bevacizumab 15 mg/kg
10872982|NCT00424840|FG001|Participant Flow|Dose Level II: 1.6 mg/m^2|Participants were given1.6 mg/m^2 Bortezomib with Carboplatin AUC6, bevacizumab 15 mg/kg
10872983|NCT00424840|FG002|Participant Flow|Dose Level III: 1.8 mg/m^2|1.8 mg/m^2 Bortezomib with Carboplatin AUC6, bevacizumab 15 mg/kg
10872984|NCT00424840|OG000|Outcome|Phase I: Dose Level 1|1.3 mg/m^2 Bortezomib
10872985|NCT00424840|OG001|Outcome|Phase 1 Dose Level II:|1.6 mg/m^2 Bortezomib
10872986|NCT00424840|OG002|Outcome|Phase I Dose Level III|1.8 mg/m^2 Bortezomib
10872987|NCT00424840|EG000|Reported Event|Phase I: Bevacizumab, Carboplatin, Bortezomib|"In phase I, three dose levels of weekly bortezomib will be studied in conjunction with fixed dose carboplatin and bevacizumab on a 21 day cycle to define the maximum tolerated dose (MTD).~Bevacizumab will be administered first followed by carboplatin followed by bortezomib"
10872988|NCT00425061|BG000|Baseline|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10872989|NCT00425061|BG001|Baseline|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10872990|NCT00425061|BG002|Baseline|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10872991|NCT00425061|BG003|Baseline|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10872992|NCT00425061|BG004|Baseline|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
10872993|NCT00425061|BG005|Baseline|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
10872994|NCT00425061|BG006|Baseline|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
10872995|NCT00425061|BG007|Baseline|Total|Total of all reporting groups
10872996|NCT00425061|FG000|Participant Flow|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10872997|NCT00425061|FG001|Participant Flow|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10872998|NCT00425061|FG002|Participant Flow|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10872999|NCT00425061|FG003|Participant Flow|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873000|NCT00425061|FG004|Participant Flow|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
10873001|NCT00425061|FG005|Participant Flow|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
10873002|NCT00425061|FG006|Participant Flow|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
10873003|NCT00425061|OG000|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873004|NCT00425061|OG001|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873005|NCT00425061|OG002|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873006|NCT00425061|OG003|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873007|NCT00425061|OG000|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
10873008|NCT00425061|OG001|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
10873009|NCT00425061|OG002|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
10873010|NCT00425061|OG000|Outcome|IMA-638|Included participants who received any dose of IMA-638 subcutaneous injection during Stage 1, 2 or 3.
10873011|NCT00425061|OG001|Outcome|Placebo|Included all participants who received placebo matched to IMA-638 subcutaneous injection during Stage 1, 2 or 3.
10873012|NCT00425061|EG000|Reported Event|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873013|NCT00425061|EG001|Reported Event|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873014|NCT00425061|EG002|Reported Event|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873015|NCT00425061|EG003|Reported Event|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
10873016|NCT00425061|EG004|Reported Event|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
10873017|NCT00425061|EG005|Reported Event|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
10873018|NCT00425061|EG006|Reported Event|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
10873019|NCT00425113|BG000|Baseline|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
10873020|NCT00425113|BG001|Baseline|Placebo|
10873021|NCT00425113|BG002|Baseline|Total|Total of all reporting groups
10873022|NCT00425113|FG000|Participant Flow|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
10873023|NCT00425113|FG001|Participant Flow|Placebo|
10873024|NCT00425113|OG000|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg three times daily or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
10873025|NCT00425113|OG001|Outcome|Placebo|
10873026|NCT00425113|OG000|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
10873027|NCT00425113|EG000|Reported Event|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
10873028|NCT00425113|EG001|Reported Event|Placebo|
10873029|NCT00425269|BG000|Baseline|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
10873030|NCT00425269|BG001|Baseline|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
10873031|NCT00425269|BG002|Baseline|Total|Total of all reporting groups
10873032|NCT00425269|FG000|Participant Flow|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
10873033|NCT00425269|FG001|Participant Flow|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
10873034|NCT00425269|OG000|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
10873035|NCT00425269|OG001|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
10873036|NCT00425269|EG000|Reported Event|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
10873037|NCT00425269|EG001|Reported Event|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
10873038|NCT00425308|BG000|Baseline|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
10873039|NCT00425308|BG001|Baseline|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
10873040|NCT00425308|BG002|Baseline|Total|Total of all reporting groups
10873041|NCT00425308|FG000|Participant Flow|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
10873042|NCT00425308|FG001|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
10873043|NCT00425308|OG000|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
10873044|NCT00425308|OG001|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
10873045|NCT00425308|EG000|Reported Event|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
10873046|NCT00425308|EG001|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
10873047|NCT00425373|BG000|Baseline|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873048|NCT00425373|BG001|Baseline|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873049|NCT00425373|BG002|Baseline|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873050|NCT00425373|BG003|Baseline|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873051|NCT00425373|BG004|Baseline|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873052|NCT00425373|BG005|Baseline|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873053|NCT00425373|BG006|Baseline|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
10873054|NCT00425373|BG007|Baseline|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
10873055|NCT00425373|BG008|Baseline|Placebo|4 tablet and 2 capsule placebos taken once daily
10873056|NCT00425373|BG009|Baseline|Total|Total of all reporting groups
10873057|NCT00425373|FG000|Participant Flow|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873058|NCT00425373|FG001|Participant Flow|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873059|NCT00425373|FG002|Participant Flow|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873060|NCT00425373|FG003|Participant Flow|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873061|NCT00425373|FG004|Participant Flow|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873062|NCT00425373|FG005|Participant Flow|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873063|NCT00425373|FG006|Participant Flow|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
10873064|NCT00425373|FG007|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
10873065|NCT00425373|FG008|Participant Flow|Placebo|4 tablet and 2 capsule placebos taken once daily
10873066|NCT00425373|OG000|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873067|NCT00425373|OG001|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873068|NCT00425373|OG002|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873069|NCT00425373|OG003|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873070|NCT00425373|OG004|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873071|NCT00425373|OG005|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873072|NCT00425373|OG006|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
10873073|NCT00425373|OG007|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
10873074|NCT00425373|OG008|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
10873075|NCT00425373|EG000|Reported Event|Placebo|4 tablet and 2 capsule placebos taken once daily
10873076|NCT00425373|EG001|Reported Event|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873077|NCT00425373|EG002|Reported Event|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873078|NCT00425373|EG003|Reported Event|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
10873079|NCT00425373|EG004|Reported Event|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873080|NCT00425373|EG005|Reported Event|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873081|NCT00425373|EG006|Reported Event|Amlodipine 5 mg|Amlodipine 2.5 mg 2 capsules plus 4 tablet placebos taken once daily
10873082|NCT00425373|EG007|Reported Event|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873083|NCT00425373|EG008|Reported Event|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
10873084|NCT00425386|BG000|Baseline|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
10873085|NCT00425386|FG000|Participant Flow|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
10873086|NCT00425386|OG000|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
10873087|NCT00425386|EG000|Reported Event|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
10873088|NCT00425477|BG000|Baseline|Bexarotene + GM-CSF|BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
10873089|NCT00425477|FG000|Participant Flow|Bexarotene + GM-CSF|BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
10873090|NCT00425477|OG000|Outcome|Bexarotene + GM-CSF|BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
10873091|NCT00425477|EG000|Reported Event|Bexarotene + GM-CSF|BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
10873092|NCT00425503|BG000|Baseline|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
10873093|NCT00425503|FG000|Participant Flow|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
10873094|NCT00425503|OG000|Outcome|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
10873095|NCT00425503|EG000|Reported Event|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
10879283|NCT00456625|OG000|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
10978324|NCT00949117|EG000|Reported Event|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
10978325|NCT00949117|EG001|Reported Event|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
10978326|NCT00949234|BG000|Baseline|PEP Group|"An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into moderate behavioral risk, or high behavioral risk. Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming."
10873096|NCT00425555|BG000|Baseline|Bexarotene Exposed|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873097|NCT00425555|BG001|Baseline|Bexarotene Naive|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873098|NCT00425555|BG002|Baseline|Total|Total of all reporting groups
10873099|NCT00425555|FG000|Participant Flow|Bexarotene Exposed|Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873100|NCT00425555|FG001|Participant Flow|Bexarotene Naive|Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873101|NCT00425555|OG000|Outcome|Bexarotene Exposed|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873102|NCT00425555|OG001|Outcome|Bexarotene Naive|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873103|NCT00425555|OG002|Outcome|All Participants|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873104|NCT00425555|OG000|Outcome|Bexarotene Exposed|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed.Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873105|NCT00425555|OG000|Outcome|All Participants|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873106|NCT00425555|EG000|Reported Event|Bexarotene Exposed|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873107|NCT00425555|EG001|Reported Event|Bexarotene Naive|Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Participants continued treatment until disease progression or unacceptable toxicity occurred.
10873108|NCT00425607|BG000|Baseline|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24-29 mo.
10873109|NCT00425607|FG000|Participant Flow|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 for patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24-29 mo.
10879284|NCT00456625|EG000|Reported Event|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
10978327|NCT00949234|FG000|Participant Flow|PEP Group|"An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into moderate behavioral risk, or high behavioral risk. Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming."
10978328|NCT00949234|OG000|Outcome|PEP Group|"An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into moderate behavioral risk, or high behavioral risk. Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming."
11098955|NCT01579045|EG002|Reported Event|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
10873110|NCT00425607|OG000|Outcome|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 for patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24-29 mo.
10873111|NCT00425607|EG000|Reported Event|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24-29 mo. Patients were monitored for liver, kidney, and hematological toxicity each month for the first 3 mo by their local physicians and every 4 mo in Boston for the duration of the study. Adverse events were monitored and recorded throughout the study.
10873112|NCT00425672|BG000|Baseline|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
10873113|NCT00425672|FG000|Participant Flow|ONTAK|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
10873114|NCT00425672|OG000|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
10873115|NCT00425672|EG000|Reported Event|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
10873116|NCT00425698|BG000|Baseline|Erythropoietin|
10873117|NCT00425698|BG001|Baseline|Placebo|
10873118|NCT00425698|BG002|Baseline|Total|Total of all reporting groups
10873119|NCT00425698|FG000|Participant Flow|Erythropoietin|
10873120|NCT00425698|FG001|Participant Flow|Placebo|
10873121|NCT00425698|OG000|Outcome|Erythropoietin|
10873122|NCT00425698|OG001|Outcome|Placebo|
10873123|NCT00425698|EG000|Reported Event|Erythropoietin|
10873124|NCT00425698|EG001|Reported Event|Placebo|
10879285|NCT00456755|BG000|Baseline|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
10879286|NCT00456755|BG001|Baseline|Placebo|The placebo contained brown colored starch resembling the SBL powder
10879287|NCT00456755|BG002|Baseline|Total|Total of all reporting groups
10879288|NCT00456755|FG000|Participant Flow|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
10879289|NCT00456755|FG001|Participant Flow|Placebo|The placebo contained brown colored starch resembling the SBL powder
10879290|NCT00456755|OG000|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
10879291|NCT00456755|OG001|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
10879292|NCT00456755|EG000|Reported Event|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
10879293|NCT00456755|EG001|Reported Event|Placebo|The placebo contained brown colored starch resembling the SBL powder
10879294|NCT00456807|BG000|Baseline|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
10879295|NCT00456807|BG001|Baseline|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
10879296|NCT00456807|BG002|Baseline|Total|Total of all reporting groups
10879297|NCT00456807|FG000|Participant Flow|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
10879298|NCT00456807|FG001|Participant Flow|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
10879299|NCT00456807|OG000|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
11007047|NCT01089127|OG005|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
10879300|NCT00456807|OG001|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
10879301|NCT00456807|EG000|Reported Event|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
10879302|NCT00456807|EG001|Reported Event|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
10879303|NCT00456846|BG000|Baseline|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
10879304|NCT00456846|BG001|Baseline|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
10879305|NCT00456846|BG002|Baseline|Total|Total of all reporting groups
10879306|NCT00456846|FG000|Participant Flow|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
10879307|NCT00456846|FG001|Participant Flow|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
10879308|NCT00456846|OG000|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
10879309|NCT00456846|OG001|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
10879310|NCT00456846|EG000|Reported Event|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
10879311|NCT00456846|EG001|Reported Event|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
10879312|NCT00456885|BG000|Baseline|All Study Participants|All participants in the study.
10879313|NCT00456885|FG000|Participant Flow|Exenatide First, Then Placebo|Started on exenatide, 3 week washout, started on placebo.
10879314|NCT00456885|FG001|Participant Flow|Placebo First, Then Exenatide|Started on placebo, three week washout, started on exenatide.
10879315|NCT00456885|OG000|Outcome|Exenatide|All participants that received exenatide.
10879316|NCT00456885|OG001|Outcome|Placebo|All participants that received placebo.
10879317|NCT00456885|EG000|Reported Event|All Study Participants|
10879318|NCT00457002|BG000|Baseline|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
10879319|NCT00457002|BG001|Baseline|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
10879320|NCT00457002|BG002|Baseline|Total|Total of all reporting groups
10879321|NCT00457002|FG000|Participant Flow|Apixaban 2.5 mg Oral|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
10879322|NCT00457002|FG001|Participant Flow|Enoxaparin 40 mg Subcutaneous|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
10879323|NCT00457002|OG000|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
10879324|NCT00457002|OG001|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
10879325|NCT00457002|EG000|Reported Event|Apix 2.5mg BID|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
10879326|NCT00457002|EG001|Reported Event|Enox 40mg QD|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
10879327|NCT00457015|BG000|Baseline|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
10879328|NCT00457015|BG001|Baseline|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
10879329|NCT00457015|BG002|Baseline|Total|Total of all reporting groups
10879330|NCT00457015|FG000|Participant Flow|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
10879331|NCT00457015|FG001|Participant Flow|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
10879332|NCT00457015|OG000|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
10879333|NCT00457015|OG001|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
10879334|NCT00457015|EG000|Reported Event|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
10879335|NCT00457015|EG001|Reported Event|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
10978329|NCT00949234|EG000|Reported Event|PEP Group|"An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into moderate behavioral risk, or high behavioral risk. Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming."
10978330|NCT00949325|BG000|Baseline|Temsirolimus Plus Liposomal Doxorubicin|"Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years.~temsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity."
10978331|NCT00949325|FG000|Participant Flow|Cohort 1, Dose Level 3|Temsirolimus 15 mg/m^2
10978332|NCT00949325|FG001|Participant Flow|Cohort 2, Dose Level 4|Temsirolimus 20 mg/m^2;
10978333|NCT00949325|FG002|Participant Flow|Cohort 3, Dose Level 5|Temsirolimus 27mg/m^2
10978334|NCT00949325|OG000|Outcome|Number of Subjects Who Experienced Dose-Limiting Toxicities|"Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years.~temsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity."
10978335|NCT00949325|OG000|Outcome|Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2|Subjects who received Temsirolimus MTD, 20 mg/m^2 in Phase I of the study and all subjects in the Phase II study were included. from both Phase I and Phase II of the study are included.
10978336|NCT00949325|OG000|Outcome|Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2|Subjects who received Temsirolimus MTD, 20 mg/m^2 in Phase I of the study and all subjects in the Phase II study were included from both Phase I and Phase II of the study who were not taken off study for early toxicity were included. Two of the eighteen subjects who were treated at the MTD were excluded.
10978337|NCT00949325|OG000|Outcome|Temsirolimus 20 mg/m^2 and 27 mg/m^2|Subjects who completed at least 2 cycles of treatment with temsirolimus dose of 20 mg/m^2 or 27 mg/m^2 were assessed for radiologic response.
10978338|NCT00949325|OG000|Outcome|Temsirolimus- Parent Drug|Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS
10978339|NCT00949325|OG001|Outcome|Sirolimus- Active Metabolite|Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. Cmax of Sirolimus was calculated using a non-compartmental model.
10978340|NCT00949325|OG000|Outcome|Temsirolimus- Parent Drug|Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. AUC was calculated using a single compartment model.
10978341|NCT00949325|OG001|Outcome|Sirolimus- Active Metabolite|Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. AUC was calculated using a single non- compartment model.
10978342|NCT00949325|OG000|Outcome|Temsirolimus- Parent Drug|Clearance was calculated using a single compartment model.
10978343|NCT00949325|OG001|Outcome|Sirolimus- Active Metabolite|
10978344|NCT00949325|OG000|Outcome|Subjects Who Received Temsirolimus MTD, 20 mg/m^2|All subjects who received at least one dose of temsirolimus at the MTD, 20 mg/M^2 plus liposomal doxorubicin were included.
10978345|NCT00949325|OG000|Outcome|Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2|All subjects who received at least one dose of temsirolimus at the MTD, 20 mg/M^2 plus liposomal doxorubicin were included.
10978346|NCT00949325|OG000|Outcome|Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2|
10978347|NCT00949325|EG000|Reported Event|Temsirolimus Plus Liposomal Doxorubicin|"Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years.~temsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity."
10978348|NCT00949533|BG000|Baseline|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
10978349|NCT00949533|BG001|Baseline|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
10978350|NCT00949533|BG002|Baseline|Total|Total of all reporting groups
10978351|NCT00949533|FG000|Participant Flow|Standard Dose|Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
10978352|NCT00949533|FG001|Participant Flow|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
10978353|NCT00949533|OG000|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
10978354|NCT00949533|OG001|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
10978355|NCT00949533|EG000|Reported Event|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
10978356|NCT00949533|EG001|Reported Event|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
10978357|NCT00949650|BG000|Baseline|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
10978358|NCT00949650|BG001|Baseline|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
10978359|NCT00949650|BG002|Baseline|Total|Total of all reporting groups
10978360|NCT00949650|FG000|Participant Flow|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
10978361|NCT00949650|FG001|Participant Flow|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
10978362|NCT00949650|OG000|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
10978363|NCT00949650|OG001|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
10978364|NCT00949650|OG000|Outcome|Afatinib 20 mg|Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.
10978365|NCT00949650|OG001|Outcome|Afatinib 30 mg|Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.
10978366|NCT00949650|OG002|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
10978367|NCT00949650|OG003|Outcome|Afatinib 50 mg|Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.
10978368|NCT00949650|EG000|Reported Event|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
10978369|NCT00949650|EG001|Reported Event|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
10978370|NCT00949702|BG000|Baseline|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
10978371|NCT00949702|FG000|Participant Flow|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
10978372|NCT00949702|OG000|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
10978373|NCT00949702|EG000|Reported Event|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
10978374|NCT00949715|BG000|Baseline|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
10978375|NCT00949715|BG001|Baseline|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
10978376|NCT00949715|BG002|Baseline|Total|Total of all reporting groups
10978377|NCT00949715|FG000|Participant Flow|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
10873125|NCT00425750|BG000|Baseline|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
10873126|NCT00425750|FG000|Participant Flow|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
10873127|NCT00425750|OG000|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
10873128|NCT00425750|EG000|Reported Event|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
10873129|NCT00425802|BG000|Baseline|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
10873130|NCT00425802|FG000|Participant Flow|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
10873131|NCT00425802|OG000|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
10873132|NCT00425802|EG000|Reported Event|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
10873133|NCT00425854|BG000|Baseline|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
10873134|NCT00425854|BG001|Baseline|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
10873135|NCT00425854|BG002|Baseline|Total|Total of all reporting groups
10873136|NCT00425854|FG000|Participant Flow|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
10873137|NCT00425854|FG001|Participant Flow|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
10873138|NCT00425854|OG000|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
10873139|NCT00425854|OG000|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
10873140|NCT00425854|OG001|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
10873141|NCT00425854|EG000|Reported Event|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
10873142|NCT00425854|EG001|Reported Event|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
10873143|NCT00425945|BG000|Baseline|Pine Bark Extract|200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily. Pine Bark Extract (Flavangenol�) : Flavangenol 200 mg per day. Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks.
10873144|NCT00425945|BG001|Baseline|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
10873145|NCT00425945|BG002|Baseline|Total|Total of all reporting groups
10873146|NCT00425945|FG000|Participant Flow|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
10873147|NCT00425945|FG001|Participant Flow|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
10879336|NCT00457197|BG000|Baseline|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
10873148|NCT00425945|OG000|Outcome|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
10873149|NCT00425945|OG001|Outcome|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
10873150|NCT00425945|OG000|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
10873151|NCT00425945|OG001|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
10873152|NCT00425945|EG000|Reported Event|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
10873153|NCT00425945|EG001|Reported Event|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
10873154|NCT00426127|BG000|Baseline|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
10873155|NCT00426127|FG000|Participant Flow|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
10873156|NCT00426127|OG000|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
10873157|NCT00426127|EG000|Reported Event|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
10873158|NCT00426153|BG000|Baseline|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
10873159|NCT00426153|BG001|Baseline|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
10873160|NCT00426153|BG002|Baseline|Total|Total of all reporting groups
10873161|NCT00426153|FG000|Participant Flow|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
10873162|NCT00426153|FG001|Participant Flow|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
10873163|NCT00426153|OG000|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
10873164|NCT00426153|OG001|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
10873165|NCT00426153|EG000|Reported Event|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
10873166|NCT00426153|EG001|Reported Event|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
10873167|NCT00426231|BG000|Baseline|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
10873168|NCT00426231|BG001|Baseline|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
10873169|NCT00426231|BG002|Baseline|Total|Total of all reporting groups
10873170|NCT00426231|FG000|Participant Flow|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
10873171|NCT00426231|FG001|Participant Flow|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
10873172|NCT00426231|OG000|Outcome|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
10873173|NCT00426231|OG001|Outcome|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
10873174|NCT00426231|EG000|Reported Event|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
10873175|NCT00426231|EG001|Reported Event|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
10873176|NCT00426270|BG000|Baseline|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
10873177|NCT00426270|FG000|Participant Flow|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
10873178|NCT00426270|OG000|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
10873179|NCT00426270|EG000|Reported Event|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
10873180|NCT00426283|BG000|Baseline|Flovent 1760 mcg|"Drug~Flovent : 880 mcg twice daily"
10873181|NCT00426283|BG001|Baseline|Placebo|Placebo twice daily
10873182|NCT00426283|BG002|Baseline|Total|Total of all reporting groups
10873183|NCT00426283|FG000|Participant Flow|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
10873184|NCT00426283|FG001|Participant Flow|Placebo|Placebo twice daily
10873185|NCT00426283|OG000|Outcome|Flovent 1760 mcg|"Drug~Flovent : 880 mcg twice daily"
10873186|NCT00426283|OG001|Outcome|Placebo|Placebo twice daily
10873187|NCT00426283|OG000|Outcome|Flovent 1760 mcg|"Fluticasone propionate 880 mcg twice daily for 3 months~Flovent: 1760 mcg daily"
10873188|NCT00426283|OG000|Outcome|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
10873189|NCT00426283|OG000|Outcome|Flovent 1760 mcg Responders|"Drug~Flovent : 1760 mcg daily"
10873190|NCT00426283|OG001|Outcome|Placebo|Placebo
10873191|NCT00426283|EG000|Reported Event|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
10873192|NCT00426283|EG001|Reported Event|Placebo|Placebo : daily
10873193|NCT00426361|BG000|Baseline|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
10873194|NCT00426361|BG001|Baseline|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
10873195|NCT00426361|BG002|Baseline|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
10873196|NCT00426361|BG003|Baseline|Total|Total of all reporting groups
10873197|NCT00426361|FG000|Participant Flow|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
10873198|NCT00426361|FG001|Participant Flow|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
10873199|NCT00426361|FG002|Participant Flow|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
10873200|NCT00426361|OG000|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
10873201|NCT00426361|OG001|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
10873202|NCT00426361|OG002|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
10873203|NCT00426361|EG000|Reported Event|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
10873204|NCT00426361|EG001|Reported Event|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
10873205|NCT00426361|EG002|Reported Event|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
10873206|NCT00426517|BG000|Baseline|Matched Related Donor Stem Cell Transplant|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
10873207|NCT00426517|BG001|Baseline|Matched Unrelated Donor Stem Cell Transplant|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
10873208|NCT00426517|BG002|Baseline|Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)|Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
10873209|NCT00426517|BG003|Baseline|Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
10873210|NCT00426517|BG004|Baseline|Total|Total of all reporting groups
10873211|NCT00426517|FG000|Participant Flow|Matched Related Donor Stem Cell Transplant|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
10873212|NCT00426517|FG001|Participant Flow|Matched Unrelated Donor Stem Cell Transplant|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
10873213|NCT00426517|FG002|Participant Flow|Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)|Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
10873214|NCT00426517|FG003|Participant Flow|Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
10873215|NCT00426517|OG000|Outcome|Matched Related Donor Stem Cell Transplant|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
10873216|NCT00426517|OG001|Outcome|Matched Unrelated Donor Stem Cell Transplant|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
10873217|NCT00426517|OG002|Outcome|Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)|Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
10873218|NCT00426517|OG003|Outcome|Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
10873219|NCT00426517|EG000|Reported Event|Matched Related Donor Stem Cell Transplant|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
10873220|NCT00426517|EG001|Reported Event|Matched Unrelated Donor Stem Cell Transplant|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
10873221|NCT00426517|EG002|Reported Event|Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)|Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
10873222|NCT00426517|EG003|Reported Event|Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
10873223|NCT00426556|BG000|Baseline|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873224|NCT00426556|BG001|Baseline|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873225|NCT00426556|BG002|Baseline|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
10873226|NCT00426556|BG003|Baseline|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873227|NCT00426556|BG004|Baseline|Total|Total of all reporting groups
10873228|NCT00426556|FG000|Participant Flow|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873229|NCT00426556|FG001|Participant Flow|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873230|NCT00426556|FG002|Participant Flow|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
10873231|NCT00426556|FG003|Participant Flow|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873232|NCT00426556|OG000|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873233|NCT00426556|OG001|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873234|NCT00426556|OG002|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
10873235|NCT00426556|OG003|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873236|NCT00426556|EG000|Reported Event|Phase I - Everolimus 5mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873237|NCT00426556|EG001|Reported Event|Phase I - Everolimus 10mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873238|NCT00426556|EG002|Reported Event|Phase I - Everolimus 30mg Weekly + PT|Phase I - Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873239|NCT00426556|EG003|Reported Event|Phase II - Everolimus 10mg Daily + PT|Phase II - Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
10873240|NCT00426660|BG000|Baseline|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
10873241|NCT00426660|FG000|Participant Flow|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
10873242|NCT00426660|OG000|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
10873243|NCT00426660|EG000|Reported Event|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
10873244|NCT00426751|BG000|Baseline|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
10873245|NCT00426751|BG001|Baseline|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
10873246|NCT00426751|BG002|Baseline|Total|Total of all reporting groups
10873247|NCT00426751|FG000|Participant Flow|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
10873248|NCT00426751|FG001|Participant Flow|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
10873249|NCT00426751|OG000|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
10873250|NCT00426751|OG001|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
10873251|NCT00426751|EG000|Reported Event|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
10873252|NCT00426751|EG001|Reported Event|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
10978378|NCT00949715|FG001|Participant Flow|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
10978379|NCT00949715|OG000|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
10978380|NCT00949715|OG001|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
10978381|NCT00949715|EG000|Reported Event|No Subjects|No subjects had adverse events or death collected as part of this study.
10978382|NCT00949884|BG000|Baseline|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
10978383|NCT00949884|BG001|Baseline|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
10978384|NCT00949884|BG002|Baseline|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
10978385|NCT00949884|BG003|Baseline|Total|Total of all reporting groups
10978386|NCT00949884|FG000|Participant Flow|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
10978387|NCT00949884|FG001|Participant Flow|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
10978388|NCT00949884|FG002|Participant Flow|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
10978389|NCT00949884|OG000|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
10978390|NCT00949884|OG001|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
10978391|NCT00949884|OG002|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
10978392|NCT00949884|OG001|Outcome|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
10978393|NCT00949884|EG000|Reported Event|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
10978394|NCT00949884|EG001|Reported Event|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
10978395|NCT00949884|EG002|Reported Event|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
10978396|NCT00949910|BG000|Baseline|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
10978397|NCT00949910|FG000|Participant Flow|Erlotinib|Erlotinib was given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). Participants were treated with 150 milligrams (mg) oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
10978398|NCT00949910|OG000|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
10978399|NCT00949910|EG000|Reported Event|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
10978400|NCT00949975|BG000|Baseline|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
10978401|NCT00949975|BG001|Baseline|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
10978402|NCT00949975|BG002|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
10978403|NCT00949975|BG003|Baseline|Placebo|Matched Placebo Tablets
10978404|NCT00949975|BG004|Baseline|Total|Total of all reporting groups
10978405|NCT00949975|FG000|Participant Flow|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
10978406|NCT00949975|FG001|Participant Flow|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
10978407|NCT00949975|FG002|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
10978408|NCT00949975|FG003|Participant Flow|Placebo|Matched Placebo Tablets
10873253|NCT00426764|BG000|Baseline|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Participants who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873254|NCT00426764|FG000|Participant Flow|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873255|NCT00426764|OG000|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873256|NCT00426764|OG000|Outcome|Missing|Participants with a missing best on study ECOG performance score, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873257|NCT00426764|OG001|Outcome|Best ECOG = 0|Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873258|NCT00426764|OG002|Outcome|Best ECOG = 1|Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873259|NCT00426764|OG003|Outcome|Best ECOG = 2|Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873260|NCT00426764|OG004|Outcome|Best ECOG = 3|Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873261|NCT00426764|OG005|Outcome|Best ECOG = 4|Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873262|NCT00426764|EG000|Reported Event|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
10873263|NCT00426842|BG000|Baseline|Arm 1|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
10873264|NCT00426842|FG000|Participant Flow|All Participants|All participants underwent a head-up tilt maneuver following no-drug, midodrine 5 mg and midodrine 10 mg, in that order, on seperate study visits. Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
10873265|NCT00426842|OG000|Outcome|No-drug|
10978409|NCT00949975|OG000|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
10873266|NCT00426842|OG001|Outcome|Midodrine 5 mg|
10873267|NCT00426842|OG002|Outcome|Midodrine 10 mg|
10873268|NCT00426842|EG000|Reported Event|All Participants|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
10873269|NCT00426855|BG000|Baseline|Group 1|Bortezomib, Bendamustin, combination chemotherapy in nhl
10873270|NCT00426855|FG000|Participant Flow|Group 1|Bortezomib, Bendamustine, NHL, combination chemotherapy
10873271|NCT00426855|OG000|Outcome|Group 1|NHL treated with combination chemotherapy of bendamustin and bortezomib
10873272|NCT00426855|EG000|Reported Event|Group 1|NHL Patients treated with combination of bendamustine and bortezomib
10873273|NCT00427011|BG000|Baseline|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
10873274|NCT00427011|FG000|Participant Flow|Perampanel|Subjects entered this open-label extension study from the double-blind core study E2007-A001-214 (NCT00165789), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
10873275|NCT00427011|OG000|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
10873276|NCT00427011|OG001|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
10873277|NCT00427011|EG000|Reported Event|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
10873278|NCT00427037|BG000|Baseline|Placebo|This is a matching placebo
10873279|NCT00427037|BG001|Baseline|Cholecalciferol|This is vitamin D3 or Cholecalciferol
10873280|NCT00427037|BG002|Baseline|Total|Total of all reporting groups
10873281|NCT00427037|FG000|Participant Flow|Placebo|This is a matching placebo
10873282|NCT00427037|FG001|Participant Flow|Cholecalciferol|This is vitamin D3 or Cholecalciferol
10873283|NCT00427037|OG000|Outcome|Placebo|"Placebo~Placebo: identical placebo pill orally by mouth"
10873284|NCT00427037|OG001|Outcome|Cholecalciferol|"D3~Cholecalciferol: 50,000 IU weekly by mouth"
10873285|NCT00427037|OG000|Outcome|Placebo|This is a matching placebo
10873286|NCT00427037|OG001|Outcome|Cholecalciferol|This is vitamin D3 or Cholecalciferol
10873287|NCT00427037|EG000|Reported Event|Placebo|This is a matching placebo
10873288|NCT00427037|EG001|Reported Event|Cholecalciferol|This is vitamin D3 or Cholecalciferol
10873289|NCT00427297|BG000|Baseline|NVP-containing|"Infants randomized to this arm will receive nevirapine-containing HAART regimen~AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen~d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen~ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen"
10873290|NCT00427297|BG001|Baseline|NVP-sparing|"Infants randomized to this arm will receive nevirapine-sparing HAART~AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen~d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of<8g/dl), AZT will be substituted for d4T.~ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen~ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen."
10873291|NCT00427297|BG002|Baseline|Total|Total of all reporting groups
10873292|NCT00427297|FG000|Participant Flow|NVP-containing|"Infants randomized to this arm will receive nevirapine-containing HAART regimen~AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen~d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen~ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen"
10873293|NCT00427297|FG001|Participant Flow|NVP-sparing|"Infants randomized to this arm will receive nevirapine-sparing HAART~AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen~d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of<8g/dl), AZT will be substituted for d4T.~ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen~ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen."
10873294|NCT00427297|OG000|Outcome|NVP-containing|"Infants randomized to this arm will receive nevirapine-containing HAART regimen~AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen~d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen~ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen"
10879337|NCT00457197|BG001|Baseline|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
10879338|NCT00457197|BG002|Baseline|Total|Total of all reporting groups
10978410|NCT00949975|OG001|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
10978411|NCT00949975|OG002|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
10978412|NCT00949975|OG003|Outcome|Placebo|Matched Placebo Tablets
10978413|NCT00949975|EG000|Reported Event|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
10978414|NCT00949975|EG001|Reported Event|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
10978415|NCT00949975|EG002|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
10978416|NCT00949975|EG003|Reported Event|Placebo|Matched Placebo Tablets
10978417|NCT00950170|BG000|Baseline|Overall Participants|All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
10978418|NCT00950170|FG000|Participant Flow|Overall Participants|All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
10978419|NCT00950170|OG000|Outcome|Overall Participants|All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
10978420|NCT00950170|OG000|Outcome|Overall Participants: First IV Infusion Per Bleed|First IV infusions of ReFacto AF received by the participants for on-demand treatment of new bleed.
10978421|NCT00950170|OG001|Outcome|Overall Participants: Follow-up IV Infusions|Follow-up IV infusions of ReFacto AF received by the participants for on-demand treatment of new bleed.
10978422|NCT00950170|OG002|Outcome|Overall Participants: All IV Infusions|A sum of all IV infusions of ReFacto AF received by the participants for on-demand treatment of new bleed.
10978423|NCT00950170|OG000|Outcome|One IV Infusion|One IV infusion of ReFacto AF received by the participants.
10978424|NCT00950170|OG001|Outcome|Two IV Infusions|Two IV infusions of ReFacto AF received by the participants.
10978425|NCT00950170|OG002|Outcome|Three IV Infusions|Three IV infusions of ReFacto AF received by the participants.
10978426|NCT00950170|OG003|Outcome|Four IV Infusions|Four IV infusions of ReFacto AF received by the participants.
10978427|NCT00950170|OG004|Outcome|Greater Than 4 IV Infusions|> 4 IV infusions of ReFacto AF received by the participants.
10978428|NCT00950170|OG005|Outcome|Total Number of Bleeds|Total number of bleeds reported in the study.
10978429|NCT00950170|OG000|Outcome|Overall Participants: Breakthrough Bleeds|All participants enrolled in the study who received at least 1 dose of ReFacto AF and had a bleeding episode within 48 hours after a prophylaxis infusion of ReFacto AF.
10978430|NCT00950170|OG000|Outcome|Overall Participants: On Demand|All participants enrolled in the study who received at least 1 dose of ReFacto AF in on demand setting.
10978431|NCT00950170|OG001|Outcome|Overall Participants: Preventive|All participants enrolled in the study who received at least 1 dose of ReFacto AF in preventive setting.
10978432|NCT00950170|OG002|Outcome|Overall Participants: Prophylaxis|All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
10978433|NCT00950170|OG003|Outcome|Overall Participants: Setting Not Specified|All participants enrolled in the study who received at least 1 dose of ReFacto AF in unspecified setting.
10978434|NCT00950170|OG004|Outcome|Overall Participants|All participants enrolled in the study who received at least 1 dose of ReFacto AF.
10978435|NCT00950170|OG000|Outcome|Overall Participants|All participants enrolled in the study who received at least 1 dose of ReFacto AF.
10978436|NCT00950170|OG000|Outcome|Overall Participants: Prophylaxis|All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
10978437|NCT00950170|OG000|Outcome|Overall Participants|All participants who received at least 1 dose of ReFacto AF.
10978438|NCT00950170|EG000|Reported Event|Overall Participants|All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
10978439|NCT00950235|BG000|Baseline|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
10978440|NCT00950235|BG001|Baseline|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
10978441|NCT00950235|BG002|Baseline|Total|Total of all reporting groups
10978442|NCT00950235|FG000|Participant Flow|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
10978443|NCT00950235|FG001|Participant Flow|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
10978444|NCT00950235|OG000|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
10978445|NCT00950235|OG001|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
10978446|NCT00950235|EG000|Reported Event|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
10978447|NCT00950235|EG001|Reported Event|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
10978448|NCT00950248|BG000|Baseline|Idebenone|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)"
10873295|NCT00427297|OG001|Outcome|NVP-sparing|"Infants randomized to this arm will receive nevirapine-sparing HAART~AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen~d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of<8g/dl), AZT will be substituted for d4T.~ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen~ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen."
10873296|NCT00427297|EG000|Reported Event|NVP-containing|"NVP-containing (AZT/3TC/NVP; d4T/3TC/NVP; or ABC/3TC/NVP) antiretroviral triple combination therapy.~Second-line regimens based on the WHO pediatric treatment guidelines, 2006."
10873297|NCT00427297|EG001|Reported Event|NVP-sparing|"NVP-sparing (AZT/3TC/LPV/r; or d4T/3TC/LPV/r1) antiretroviral triple combination therapy.~Second-line regimens based on the WHO pediatric treatment guidelines, 2006."
10873298|NCT00427336|BG000|Baseline|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
10873299|NCT00427336|FG000|Participant Flow|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
10873300|NCT00427336|OG000|Outcome|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
10873301|NCT00427336|EG000|Reported Event|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
10873302|NCT00427349|BG000|Baseline|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
10873303|NCT00427349|FG000|Participant Flow|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
10873304|NCT00427349|OG000|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
10873305|NCT00427349|EG000|Reported Event|MG 706+Octreotide|AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment. Each cycle was defined as 28 days. AMG 706 was started within 7 working days of registration, given on the same day as the octreotide-LAR.
10873306|NCT00427557|BG000|Baseline|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
10873307|NCT00427557|FG000|Participant Flow|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
10873308|NCT00427557|OG000|Outcome|Fludarabine + Melphalan + Umbilical Cord Blood Unit|Fludarabine 30 mg/m^2 given daily for four days. Melphalan 140 mg/m^2 given for one day. Umbilical Cord Blood Unit given on one day.
10873309|NCT00427557|EG000|Reported Event|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
10873310|NCT00427635|BG000|Baseline|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
10873311|NCT00427635|BG001|Baseline|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
10873312|NCT00427635|BG002|Baseline|Total|Total of all reporting groups
10873313|NCT00427635|FG000|Participant Flow|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
10873314|NCT00427635|FG001|Participant Flow|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
10873315|NCT00427635|OG000|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
10873316|NCT00427635|OG001|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
10873317|NCT00427635|EG000|Reported Event|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
10873318|NCT00427635|EG001|Reported Event|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
10873319|NCT00427648|BG000|Baseline|1/Active|alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
10873320|NCT00427648|BG001|Baseline|2/Placebo|normal saline
10873321|NCT00427648|BG002|Baseline|Total|Total of all reporting groups
10873322|NCT00427648|FG000|Participant Flow|1/Active|alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
10873323|NCT00427648|FG001|Participant Flow|2/Placebo|normal saline
10873324|NCT00427648|OG000|Outcome|1/Active|alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
10873325|NCT00427648|OG001|Outcome|2/Placebo|normal saline
10873326|NCT00427648|OG000|Outcome|1/Xylocaine|alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks
10873327|NCT00427648|OG001|Outcome|2/Normal Saline|placebo: normal saline
10873328|NCT00427648|EG000|Reported Event|1/Active|alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
10873329|NCT00427648|EG001|Reported Event|2/Placebo|normal saline
10873330|NCT00427661|BG000|Baseline|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
10873331|NCT00427661|FG000|Participant Flow|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
10873332|NCT00427661|OG000|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
10873333|NCT00427661|OG000|Outcome|Experimental|Busulfan, Fludarabine, Cyclosporine, MMF
10873334|NCT00427661|EG000|Reported Event|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
10873335|NCT00427700|BG000|Baseline|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle~raloxifene: 100mg PO on days 5-9 of the menstrual cycle"
10873336|NCT00427700|BG001|Baseline|Clomiphene|"Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle~clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle"
10873337|NCT00427700|BG002|Baseline|Total|Total of all reporting groups
10873338|NCT00427700|FG000|Participant Flow|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
10873339|NCT00427700|FG001|Participant Flow|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
10873340|NCT00427700|OG000|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
10873341|NCT00427700|OG001|Outcome|Raloxifene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
10873342|NCT00427700|OG001|Outcome|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
10873343|NCT00427700|EG000|Reported Event|Clomiphene Citrate|"Use of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle~clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle~One woman in the CC group had nausea, headache, and abdominal bloating."
10873344|NCT00427700|EG001|Reported Event|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle~raloxifene: 100mg PO on days 5-9 of the menstrual cycle~Two cases: one woman had nausea, and the other woman had nausea, headache, and pelvic pain. All mild"
10873345|NCT00427765|BG000|Baseline|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
10873346|NCT00427765|FG000|Participant Flow|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
10873347|NCT00427765|OG000|Outcome|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
10873348|NCT00427765|EG000|Reported Event|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
10873349|NCT00427778|BG000|Baseline|All Study Participants|All participants who were randomised to a treatment sequence group
10873350|NCT00427778|FG000|Participant Flow|Incontinence Ring, Then no Treatment|participants first were fitted to an incontinence ring, which they wore for a period of 4 weeks, then it was removed. After a washout period of 2 weeks, they continued evaluation but with no active treatment
10873351|NCT00427778|FG001|Participant Flow|No Treatment, Then Incontinence Ring|Participants first were assessment while no active treatment was received, for a period of 4 weeks. After a washout period of 2 weeks, they continued evaluation after an incontinence ring was fitted.
10873352|NCT00427778|OG000|Outcome|Incontinence Ring|participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (<50% improvement from baseline)
10873353|NCT00427778|OG001|Outcome|Controls|participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as <50% improvement from baseline.
10873354|NCT00427778|OG000|Outcome|Incontinence Ring|Use of incontinence ring
10873355|NCT00427778|OG001|Outcome|Controls|no treatment
10873356|NCT00427778|OG000|Outcome|Incontinence Ring|participants completed the UDI questionnaire at the end of 4 weeks of ring use.
10873357|NCT00427778|OG001|Outcome|Controls|participants completed the UDI questionnaire at the end of 4 weeks of the 'no treatment' week.
10873358|NCT00427778|OG000|Outcome|Incontinence Ring|UDS done with ring in situ. UDS was performed while using the ring, towards the end of the 4-week ring use period.
10879339|NCT00457197|FG000|Participant Flow|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
10978449|NCT00950248|BG001|Baseline|Placebo|"Placebo tablets administered orally as five tablets, three times per day with food.~placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)"
10978450|NCT00950248|BG002|Baseline|Total|Total of all reporting groups
10978451|NCT00950248|FG000|Participant Flow|Untreated|Patients in their first year baseline prior to study drug phase
10978452|NCT00950248|FG001|Participant Flow|Idebenone|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)"
10978453|NCT00950248|FG002|Participant Flow|Placebo|"Placebo tablets administered orally as five tablets, three times per day with food.~placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)"
10978454|NCT00950248|OG000|Outcome|Idebenone|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)"
10978455|NCT00950248|OG001|Outcome|Placebo|"Placebo tablets administered orally as five tablets, three times per day with food.~placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)"
10978456|NCT00950248|EG000|Reported Event|Untreated|Patients in their first year baseline prior to study drug phase
10978457|NCT00950248|EG001|Reported Event|Idebenone|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)"
10978458|NCT00950248|EG002|Reported Event|Placebo|"Placebo tablets administered orally as five tablets, three times per day with food.~placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)"
10978459|NCT00950300|BG000|Baseline|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
10978460|NCT00950300|BG001|Baseline|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
10978461|NCT00950300|BG002|Baseline|Total|Total of all reporting groups
10978462|NCT00950300|FG000|Participant Flow|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 milligrams per meter-squared (mg/m^2) every 21 days for four cycles followed by 5-fluorouracil 500 mg/m^2, epirubicin 75 mg/m^2, and cyclophosphamide 500 mg/m^2 (FEC) every 21 days for four cycles. Herceptin was administered as 8 milligrams per kilogram (mg/kg) on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the Treatment-Free Follow-Up (TFFU) Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the Survival Follow-Up (SFU) Period.
10978463|NCT00950300|FG001|Participant Flow|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-milligram (mg) fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
10978464|NCT00950300|OG000|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
10978465|NCT00950300|OG001|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
10978466|NCT00950300|OG000|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
10978467|NCT00950300|EG000|Reported Event|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
10978468|NCT00950300|EG001|Reported Event|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
10978469|NCT00950352|BG000|Baseline|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
10978470|NCT00950352|BG001|Baseline|Placebo|"32 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Placebo: Subjects were given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
10978471|NCT00950352|BG002|Baseline|Total|Total of all reporting groups
10978472|NCT00950352|FG000|Participant Flow|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
10978473|NCT00950352|FG001|Participant Flow|Placebo|"32 subjects with methamphetamine dependence were treated with placebo for 8-9 weeks.~Placebo: Subjects were given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
10978474|NCT00950352|OG000|Outcome|Citicoline|Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
10978475|NCT00950352|OG001|Outcome|Placebo|Subjects will be given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
10978476|NCT00950352|EG000|Reported Event|Citicoline|
10978477|NCT00950352|EG001|Reported Event|Placebo|
10978478|NCT00950365|BG000|Baseline|Arm A (Pemetrexed)|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10978479|NCT00950365|BG001|Baseline|Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)|"Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10978480|NCT00950365|BG002|Baseline|Total|Total of all reporting groups
10978481|NCT00950365|FG000|Participant Flow|Arm A (Pemetrexed)|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10978482|NCT00950365|FG001|Participant Flow|Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)|"Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10978483|NCT00950365|OG000|Outcome|Arm A (Pemetrexed)|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10978484|NCT00950365|OG001|Outcome|Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)|"Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10978485|NCT00950365|EG000|Reported Event|Arm A (Pemetrexed)|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10978486|NCT00950365|EG001|Reported Event|Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)|"Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10978487|NCT00950599|BG000|Baseline|Saxagliptin 2.5 mg (0-40 mg Cohort)|
10978488|NCT00950599|BG001|Baseline|Saxagliptin 5 mg (0-40 mg Cohort)|
10978489|NCT00950599|BG002|Baseline|Saxagliptin 10 mg (0-40 mg Cohort)|
10978490|NCT00950599|BG003|Baseline|Saxagliptin 20 mg (0-40 mg Cohort)|
10978491|NCT00950599|BG004|Baseline|Saxagliptin 40 mg (0-40 mg Cohort)|
10978492|NCT00950599|BG005|Baseline|Placebo (0-40 mg Cohort)|
10978493|NCT00950599|BG006|Baseline|Saxagliptin 100 mg (0 & 100 mg Cohort)|
10978494|NCT00950599|BG007|Baseline|Placebo (0 & 100 mg Cohort)|
10978495|NCT00950599|BG008|Baseline|Total|Total of all reporting groups
10978496|NCT00950599|FG000|Participant Flow|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
10978497|NCT00950599|FG001|Participant Flow|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
10978498|NCT00950599|FG002|Participant Flow|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
10978499|NCT00950599|FG003|Participant Flow|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
10978500|NCT00950599|FG004|Participant Flow|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
10978501|NCT00950599|FG005|Participant Flow|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
10978502|NCT00950599|FG006|Participant Flow|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
10978503|NCT00950599|FG007|Participant Flow|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
10978504|NCT00950599|FG008|Participant Flow|Saxa 0-40 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
10978505|NCT00950599|FG009|Participant Flow|Saxa 0 & 100 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
10978506|NCT00950599|OG000|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
10978507|NCT00950599|OG001|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
10978508|NCT00950599|OG002|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
10978509|NCT00950599|OG003|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
10978510|NCT00950599|OG004|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
10978511|NCT00950599|OG005|Outcome|Placebo (0-40 mg Cohort)|
10978512|NCT00950599|OG006|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
10978513|NCT00950599|OG007|Outcome|Placebo (0 & 100 mg Cohort)|
10978514|NCT00950599|OG006|Outcome|Saxagliptin 100 mg (0, 100 mg Cohort)|
10978515|NCT00950599|OG007|Outcome|Placebo (0, 100 mg Cohort)|
10978516|NCT00950599|OG000|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
10978517|NCT00950599|OG001|Outcome|Placebo (0 & 100 mg Cohort)|
10978518|NCT00950599|OG001|Outcome|Placebo (0 & 100 Cohort)|
10978519|NCT00950599|EG000|Reported Event|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
10978520|NCT00950599|EG001|Reported Event|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
10978521|NCT00950599|EG002|Reported Event|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
10978522|NCT00950599|EG003|Reported Event|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
10978523|NCT00950599|EG004|Reported Event|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
10978524|NCT00950599|EG005|Reported Event|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
10978525|NCT00950599|EG006|Reported Event|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
10978526|NCT00950599|EG007|Reported Event|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
10978527|NCT00950612|BG000|Baseline|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.
10978528|NCT00950612|BG001|Baseline|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
10978529|NCT00950612|BG002|Baseline|Total|Total of all reporting groups
10978530|NCT00950612|FG000|Participant Flow|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.
10978531|NCT00950612|FG001|Participant Flow|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
10978532|NCT00950612|OG000|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.
10978533|NCT00950612|OG001|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
10978534|NCT00950612|EG000|Reported Event|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.
10978535|NCT00950612|EG001|Reported Event|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
10978536|NCT00950651|BG000|Baseline|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
10978537|NCT00950651|BG001|Baseline|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
10978538|NCT00950651|BG002|Baseline|Total|Total of all reporting groups
10978539|NCT00950651|FG000|Participant Flow|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
10978540|NCT00950651|FG001|Participant Flow|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
10848603|NCT00290654|EG000|Reported Event|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
10978541|NCT00950651|OG000|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
10978542|NCT00950651|OG001|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
10978543|NCT00950651|EG000|Reported Event|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
10978544|NCT00950651|EG001|Reported Event|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
10978545|NCT00950664|BG000|Baseline|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
10978546|NCT00950664|BG001|Baseline|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
10978547|NCT00950664|BG002|Baseline|Total|Total of all reporting groups
10978548|NCT00950664|FG000|Participant Flow|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
10978549|NCT00950664|FG001|Participant Flow|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
10978550|NCT00950664|OG000|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
10978551|NCT00950664|OG001|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
10978552|NCT00950664|EG000|Reported Event|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
10978553|NCT00950664|EG001|Reported Event|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
10978554|NCT00950729|BG000|Baseline|Healthy Subjects|
10978555|NCT00950729|FG000|Participant Flow|Healthy Subjects|
10978556|NCT00950729|OG000|Outcome|Healthy Subjects|
10978557|NCT00950729|EG000|Reported Event|Healthy Subjects|
10978558|NCT00950742|BG000|Baseline|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
10978559|NCT00950742|BG001|Baseline|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
10978560|NCT00950742|BG002|Baseline|Total|Total of all reporting groups
10978561|NCT00950742|FG000|Participant Flow|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
10978562|NCT00950742|FG001|Participant Flow|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
10978563|NCT00950742|OG000|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.
10978564|NCT00950742|OG001|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
10978565|NCT00950742|OG000|Outcome|Afatinib|All patients received both Afatinib and Herceptin. Dose level 1 was continuous daily dosing with Afatinib 20mg tablets and once weekly an intravenous infusion of Herceptin. Dose level 2 was continuous daily dosing with Afatinib 30mg tablets and once weekly an intravenous infusion of Herceptin. Cycle length was 28 days.
10978566|NCT00950742|OG000|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
10978567|NCT00950742|OG001|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
10978568|NCT00950742|OG000|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
10978569|NCT00950742|EG000|Reported Event|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
10978570|NCT00950742|EG001|Reported Event|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
10978571|NCT00950755|BG000|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10978572|NCT00950755|FG000|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10978573|NCT00950755|OG000|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10978574|NCT00950755|EG000|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10978575|NCT00950807|BG000|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods, each separated by a 10-14 day washout period. Participants were randomly assigned to receive a sequence of placebo and 2 of the 9 active treatments :~UMEC 62.5, 125, 250, 500, and 1000 µg QD, UMEC 62.5, 125, and 250 µg BID, tiotropium 18 µg QD."
10978576|NCT00950807|FG000|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
10978577|NCT00950807|FG001|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10848604|NCT00290693|BG000|Baseline|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
10978578|NCT00950807|FG002|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978579|NCT00950807|FG003|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978580|NCT00950807|FG004|Participant Flow|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978581|NCT00950807|FG005|Participant Flow|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978582|NCT00950807|FG006|Participant Flow|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978583|NCT00950807|FG007|Participant Flow|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978584|NCT00950807|FG008|Participant Flow|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978585|NCT00950807|FG009|Participant Flow|Tiotropium 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
10978586|NCT00950807|OG000|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
10978587|NCT00950807|OG001|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978588|NCT00950807|OG002|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978589|NCT00950807|OG003|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978590|NCT00950807|OG004|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978591|NCT00950807|OG005|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978592|NCT00950807|OG006|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978593|NCT00950807|OG007|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978594|NCT00950807|OG008|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978595|NCT00950807|OG009|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
10978596|NCT00950807|EG000|Reported Event|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
10978597|NCT00950807|EG001|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978598|NCT00950807|EG002|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978599|NCT00950807|EG003|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978600|NCT00950807|EG004|Reported Event|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978601|NCT00950807|EG005|Reported Event|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
10978602|NCT00950807|EG006|Reported Event|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978603|NCT00950807|EG007|Reported Event|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978604|NCT00950807|EG008|Reported Event|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
10978605|NCT00950807|EG009|Reported Event|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
10978606|NCT00950833|BG000|Baseline|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
10978607|NCT00950833|BG001|Baseline|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
10978608|NCT00950833|BG002|Baseline|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
10978609|NCT00950833|BG003|Baseline|Total|Total of all reporting groups
10978610|NCT00950833|FG000|Participant Flow|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
10978611|NCT00950833|FG001|Participant Flow|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
10978612|NCT00950833|FG002|Participant Flow|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
10978613|NCT00950833|OG000|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
10978614|NCT00950833|OG001|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
10978615|NCT00950833|OG000|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
10978616|NCT00950833|OG001|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
10978617|NCT00950833|OG002|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
10978618|NCT00950833|EG000|Reported Event|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
10848605|NCT00290693|FG000|Participant Flow|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
10978619|NCT00950833|EG001|Reported Event|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
10978620|NCT00950833|EG002|Reported Event|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
10848606|NCT00290693|OG000|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
10978621|NCT00950859|BG000|Baseline|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
10978622|NCT00950859|BG001|Baseline|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
10978623|NCT00950859|BG002|Baseline|Total|Total of all reporting groups
10978624|NCT00950859|FG000|Participant Flow|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
10978625|NCT00950859|FG001|Participant Flow|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
10978626|NCT00950859|OG000|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
10978627|NCT00950859|OG001|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
10978628|NCT00950859|EG000|Reported Event|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
10978629|NCT00950859|EG001|Reported Event|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
10978630|NCT00950872|BG000|Baseline|Duet TRS|"Subjects receive Duet TRS~Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS."
10978631|NCT00950872|FG000|Participant Flow|Duet TRS|Duet TRS is a staple line buttress
10978632|NCT00950872|OG000|Outcome|Duet TRS|Duet TRS is a staple line buttress
10978633|NCT00950872|EG000|Reported Event|Duet TRS|Duet TRS is a staple line buttress
10978634|NCT00950911|BG000|Baseline|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
10978635|NCT00950911|BG001|Baseline|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
10978636|NCT00950911|BG002|Baseline|Total|Total of all reporting groups
10978637|NCT00950911|FG000|Participant Flow|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
10978638|NCT00950911|FG001|Participant Flow|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
10978639|NCT00950911|OG000|Outcome|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
10978640|NCT00950911|OG001|Outcome|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
10978641|NCT00950911|EG000|Reported Event|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
10978642|NCT00950911|EG001|Reported Event|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
10978643|NCT00950950|BG000|Baseline|Placebo|Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978644|NCT00950950|BG001|Baseline|Romosozumab|Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978645|NCT00950950|BG002|Baseline|Total|Total of all reporting groups
10978646|NCT00950950|FG000|Participant Flow|Placebo|Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978647|NCT00950950|FG001|Participant Flow|Romosozumab|Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978648|NCT00950950|OG000|Outcome|Placebo|Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978649|NCT00950950|OG001|Outcome|Romosozumab|Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978650|NCT00950950|OG000|Outcome|Romosozumab|Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978651|NCT00950950|EG000|Reported Event|Placebo|Participants received matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978652|NCT00950950|EG001|Reported Event|Romosozumab|Participants received 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
10978653|NCT00950963|BG000|Baseline|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
10978654|NCT00950963|BG001|Baseline|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
10978655|NCT00950963|BG002|Baseline|Total|Total of all reporting groups
10978656|NCT00950963|FG000|Participant Flow|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
10848607|NCT00290693|OG000|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
10978657|NCT00950963|FG001|Participant Flow|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
10978658|NCT00950963|OG000|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
10978659|NCT00950963|OG001|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
10978660|NCT00950963|EG000|Reported Event|Phone Counseling|"The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.~Phone Counseling: Patient were contacted on a periodic basis via telephone to address there diabetes care."
10978661|NCT00950963|EG001|Reported Event|Standard Care|"Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.~Standard Clinical Care: Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses."
10978662|NCT00951015|BG000|Baseline|DTG 10 mg QD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
10978663|NCT00951015|BG001|Baseline|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978664|NCT00951015|BG002|Baseline|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978665|NCT00951015|BG003|Baseline|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978666|NCT00951015|BG004|Baseline|Total|Total of all reporting groups
10978667|NCT00951015|FG000|Participant Flow|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
10978668|NCT00951015|FG001|Participant Flow|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978669|NCT00951015|FG002|Participant Flow|DTG 50 mg QD|Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978670|NCT00951015|FG003|Participant Flow|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978671|NCT00951015|FG004|Participant Flow|Open-label DTG 50 mg QD|All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
10978672|NCT00951015|OG000|Outcome|DTG 10 mg QD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
10978673|NCT00951015|OG001|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978674|NCT00951015|OG002|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978675|NCT00951015|OG003|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978676|NCT00951015|OG000|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978677|NCT00951015|OG000|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
10978678|NCT00951015|OG001|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
10978679|NCT00951015|OG002|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
10978680|NCT00951015|OG000|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
10978681|NCT00951015|OG000|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
10978682|NCT00951015|OG001|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
10978683|NCT00951015|OG002|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
10978684|NCT00951015|OG003|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
10978685|NCT00951015|OG004|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
10978686|NCT00951015|OG000|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
10978687|NCT00951015|OG000|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD).
10978688|NCT00951015|EG000|Reported Event|DTG 10mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978689|NCT00951015|EG001|Reported Event|DTG 25mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978690|NCT00951015|EG002|Reported Event|DTG 50mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978691|NCT00951015|EG003|Reported Event|EFV 600mg|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
10978692|NCT00951015|EG004|Reported Event|Open-label DTG 50 mg QD|All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
10978693|NCT00951041|BG000|Baseline|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978694|NCT00951041|BG001|Baseline|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978695|NCT00951041|BG002|Baseline|Total|Total of all reporting groups
10978696|NCT00951041|FG000|Participant Flow|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978697|NCT00951041|FG001|Participant Flow|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978698|NCT00951041|OG000|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978699|NCT00951041|OG001|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978700|NCT00951041|OG000|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978701|NCT00951041|EG000|Reported Event|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978702|NCT00951041|EG001|Reported Event|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10978703|NCT00951080|BG000|Baseline|SNaP Wound Care System|SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
10978704|NCT00951080|BG001|Baseline|Traditional NPWT System|Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
10978705|NCT00951080|BG002|Baseline|Total|Total of all reporting groups
10978706|NCT00951080|FG000|Participant Flow|SNaP Wound Care System|SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
10978707|NCT00951080|FG001|Participant Flow|Traditional NPWT System|Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
10978708|NCT00951080|OG000|Outcome|SNaP Wound Care System|SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
10978709|NCT00951080|OG001|Outcome|Traditional NPWT System|Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
10978710|NCT00951080|EG000|Reported Event|SNaP Wound Care System|SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
10978711|NCT00951080|EG001|Reported Event|Traditional NPWT System|Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
10848608|NCT00290693|EG000|Reported Event|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
10848609|NCT00290706|BG000|Baseline|Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.3 mg/m2|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.3 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10978712|NCT00951093|BG000|Baseline|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery.
10978713|NCT00951093|FG000|Participant Flow|Patients Assessed for GERD|Patients assessed for GERD before and after Gastric Bypass Surgery
10978714|NCT00951093|OG000|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
10978715|NCT00951093|OG001|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
10978716|NCT00951093|OG002|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
10978717|NCT00951093|EG000|Reported Event|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery
10978718|NCT00951171|BG000|Baseline|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
10978719|NCT00951171|BG001|Baseline|Standard IUI|Insemination with TOmcat catheter
10978720|NCT00951171|BG002|Baseline|Total|Total of all reporting groups
10978721|NCT00951171|FG000|Participant Flow|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
10978722|NCT00951171|FG001|Participant Flow|Standard IUI|Insemination with TOmcat catheter
10978723|NCT00951171|OG000|Outcome|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
10978724|NCT00951171|OG001|Outcome|Standard IUI|Insemination with TOmcat catheter
10978725|NCT00951171|EG000|Reported Event|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
10978726|NCT00951171|EG001|Reported Event|Standard IUI|Insemination with TOmcat catheter
10978727|NCT00951275|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
10978728|NCT00951275|FG000|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum dose 800 mg) intravenously (IV) once every 4 weeks for a total of 6 infusions.
10978729|NCT00951275|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
10978730|NCT00951275|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
10978731|NCT00951379|BG000|Baseline|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
10978732|NCT00951379|BG001|Baseline|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
10978733|NCT00951379|BG002|Baseline|Total|Total of all reporting groups
10978734|NCT00951379|FG000|Participant Flow|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
10978735|NCT00951379|FG001|Participant Flow|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
10978736|NCT00951379|OG000|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
10978737|NCT00951379|OG001|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
10978738|NCT00951379|OG000|Outcome|Pioglitazone: CRP>5 at Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
10978739|NCT00951379|OG001|Outcome|Pioglitazone: CRP>5 End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
10978740|NCT00951379|OG002|Outcome|Placebo: CRP> 5 Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
10978741|NCT00951379|OG003|Outcome|Placebo: CRP>5 End of Study|Measure at end of Placebo treatment, approximately 24 weeks
10978742|NCT00951379|OG000|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
10978743|NCT00951379|OG001|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
10978744|NCT00951379|OG002|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
10978745|NCT00951379|OG003|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
10978746|NCT00951379|EG000|Reported Event|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
10978747|NCT00951379|EG001|Reported Event|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
10978748|NCT00951483|BG000|Baseline|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
10978749|NCT00951483|BG001|Baseline|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
10978750|NCT00951483|BG002|Baseline|Total|Total of all reporting groups
10978751|NCT00951483|FG000|Participant Flow|Intervention Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
10978752|NCT00951483|FG001|Participant Flow|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
10978753|NCT00951483|OG000|Outcome|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
10978754|NCT00951483|OG001|Outcome|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
10978755|NCT00951483|OG000|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
10978756|NCT00951483|OG001|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
10978757|NCT00951483|EG000|Reported Event|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
10978758|NCT00951483|EG001|Reported Event|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
10978759|NCT00951496|BG000|Baseline|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
10978760|NCT00951496|BG001|Baseline|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
10978761|NCT00951496|BG002|Baseline|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
10978762|NCT00951496|BG003|Baseline|Total|Total of all reporting groups
10978763|NCT00951496|FG000|Participant Flow|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
10978764|NCT00951496|FG001|Participant Flow|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
10978765|NCT00951496|FG002|Participant Flow|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
10978766|NCT00951496|OG000|Outcome|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
10978767|NCT00951496|OG001|Outcome|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
10978768|NCT00951496|OG002|Outcome|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
10978769|NCT00951496|OG000|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10978770|NCT00951496|OG001|Outcome|Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)|"Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Carboplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10978771|NCT00951496|OG002|Outcome|Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)|"Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Cisplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Paclitaxel: Given IP~Quality-of-Life Assessment: Ancillary studies"
10978772|NCT00951496|EG000|Reported Event|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
10978773|NCT00951496|EG001|Reported Event|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
10978774|NCT00951496|EG002|Reported Event|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
10978775|NCT00951509|BG000|Baseline|All Subjects|"Power Mobility Road Test (PMRT): All subjects were asked to complete the real world power mobility evaluation via the PMRT.~Computer-Based Test: All subjects were asked to complete the computer-based evaluation designed to simulate real world driving in a 2D environment.~Virtual Reality Test: All subjects were asked to complete the virtual-based evaluation designed to simulate real world driving in a 3D environment."
10978776|NCT00951509|FG000|Participant Flow|Participants Who Qualified for the Study|All participants who qualified for the study, performed electric power wheelchair (EPW) driving under five driving conditions, while clinicians observed and assessed the EPW users' driving performance. The first four conditions were conducted in virtual environments (with different interfaces in each condition, as listed below) and condition 5 was conducted in the real world - Condition 1 - Desktop screens with no roller systems Condition 2- Desktop screens with roller systems Condition 3 - Immersive virtual reality screens with no roller systems Condition 4 - Immersive virtual reality screens with roller systems Condition 5 - Real world EPW driving
10978777|NCT00951509|OG000|Outcome|Condition 1|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
10978778|NCT00951509|OG001|Outcome|Condition 2|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
10978779|NCT00951509|OG002|Outcome|Condition 3|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
10978780|NCT00951509|OG003|Outcome|Condition 4|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
10978781|NCT00951509|OG004|Outcome|Condition 5|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
10978782|NCT00951509|EG000|Reported Event|Power Mobility Road Test|"With 12 structured tasks and 4 dynamic tasks, adding to a total of 16 tasks with a minimum score of 1 and maximum of 4 in each task, it is possible to score in the range of 16 - 64 during a driving trial. To assess the driving performance, the total score for each trial was calculated and expressed as a percentage, termed Composite score. A Composite score of 95 % or greater would suggest that the user is a safe driver."
10978783|NCT00951561|BG000|Baseline|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
10978784|NCT00951561|FG000|Participant Flow|Vipon/Ibuprofen/Vipon/Ibuprofen|Subjects participated for a total of 4 menstrual cycles. Subjects used either VIPON as a medical device or up to 2 ibuprofen tablets (each tablet containing 200 mg ibuprofen) during the first menstrual cycle. Subjects used crossover treatment during second menstrual cycle, randomized for cycle 3, and crossed over for cycle 4. All subjects used tampons for absorption of menstrual fluid during treatment and at least 2 hours post treatment. Subjects taking ibuprofen also used a tampon during treatment.
10978785|NCT00951561|FG001|Participant Flow|Ibuprofen/Vipon/Ibuprofen/Vipon|
10978786|NCT00951561|FG002|Participant Flow|Vipon/Ibuprofen/Ibuprofen/Vipon|
10978787|NCT00951561|FG003|Participant Flow|Ibuprofen/Vipon/Vipon/Ibuprofen|
10978788|NCT00951561|OG000|Outcome|VIPON|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
10978789|NCT00951561|OG001|Outcome|Ibuprofen|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
10978790|NCT00951561|EG000|Reported Event|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
10978791|NCT00951665|BG000|Baseline|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
10978792|NCT00951665|BG001|Baseline|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
10978793|NCT00951665|BG002|Baseline|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
10978794|NCT00951665|BG003|Baseline|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
10978795|NCT00951665|BG004|Baseline|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
10978796|NCT00951665|BG005|Baseline|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
10978797|NCT00951665|BG006|Baseline|Total|Total of all reporting groups
10978798|NCT00951665|FG000|Participant Flow|Phase Ib Regimen 1|Participants received trastuzumab emtansine (T-DM1) every three weeks (Q3W) + paclitaxel weekly (QW) intravenously.
10978799|NCT00951665|FG001|Participant Flow|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
10978800|NCT00951665|FG002|Participant Flow|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
10978801|NCT00951665|FG003|Participant Flow|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
10978802|NCT00951665|FG004|Participant Flow|Phase IIa Group A|Participants received maximum tolerated dose (MTD) from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
10978803|NCT00951665|FG005|Participant Flow|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
10978804|NCT00951665|OG000|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
10978805|NCT00951665|OG001|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
10978806|NCT00951665|OG002|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
10978807|NCT00951665|OG003|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
10978808|NCT00951665|OG004|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
10978809|NCT00951665|OG005|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
10978810|NCT00951665|OG000|Outcome|Phase IIa Group A|Participants received MTD from Phase Ib i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
10978811|NCT00951665|OG001|Outcome|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab 420 mg Q3W intravenously.
10978812|NCT00951665|OG005|Outcome|Phase IIa Group B|Participants received of T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab Q3W intravenously.
10978813|NCT00951665|OG000|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
10978814|NCT00951665|OG001|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
10978815|NCT00951665|OG002|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
10978816|NCT00951665|OG003|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
10978817|NCT00951665|OG004|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
10978818|NCT00951665|OG005|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
10978819|NCT00951665|OG000|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
10978820|NCT00951665|OG001|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
10978821|NCT00951665|OG002|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
10978822|NCT00951665|OG003|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
10978823|NCT00951665|OG004|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
10978824|NCT00951665|OG000|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
10978825|NCT00951665|OG001|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
10978826|NCT00951665|OG002|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
10978827|NCT00951665|OG003|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
10978828|NCT00951665|OG004|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
10978829|NCT00951665|OG000|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
10978830|NCT00951665|EG000|Reported Event|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
10978831|NCT00951665|EG001|Reported Event|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
10978832|NCT00951665|EG002|Reported Event|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
10978833|NCT00951665|EG003|Reported Event|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
10978834|NCT00951665|EG004|Reported Event|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
10978835|NCT00951665|EG005|Reported Event|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
10978836|NCT00951808|BG000|Baseline|All Participants|237 subjects enrolled in the feasibility study.
10978837|NCT00951808|FG000|Participant Flow|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
10978838|NCT00951808|FG001|Participant Flow|Standard Care Trial Cohort|Subjects received standard care (regular care for acute chest syndrome (ACS)) without a clinically indicated transfusion.
10978839|NCT00951808|FG002|Participant Flow|Standard Care Observational Cohort|Subjects who are ineligible for or who decline the blood transfusion part of the study participated in the observational portion of the study and received standard care (regular care for acute chest syndrome (ACS)).
10978840|NCT00951808|OG000|Outcome|Adults|Age >= 18
10978841|NCT00951808|OG001|Outcome|Children|Age < 18
10978842|NCT00951808|OG002|Outcome|Overall|Both adults and children
10978843|NCT00951808|EG000|Reported Event|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
11007048|NCT01089127|EG000|Reported Event|Indacaterol 18.75 ug|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007049|NCT01089127|EG001|Reported Event|Indacaterol 37.5 ug|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11098956|NCT01579045|EG003|Reported Event|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
10978844|NCT00951821|BG000|Baseline|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
10978845|NCT00951821|BG001|Baseline|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
10978846|NCT00951821|BG002|Baseline|Total|Total of all reporting groups
10978847|NCT00951821|FG000|Participant Flow|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
10978848|NCT00951821|FG001|Participant Flow|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
10978849|NCT00951821|OG000|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
10978850|NCT00951821|OG001|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
10978851|NCT00951821|EG000|Reported Event|Concurrent Treatment|"Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent treatment: Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
10978852|NCT00951821|EG001|Reported Event|Adolescent Treatment Only|"Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.~Adolescent treatment only: Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
10978853|NCT00951899|BG000|Baseline|Colesevelam|Treatment with colesevelam in addition to metformin and diet
10978854|NCT00951899|BG001|Baseline|Placebo|Placebo plus diet and metformin
10978855|NCT00951899|BG002|Baseline|Total|Total of all reporting groups
10978856|NCT00951899|FG000|Participant Flow|Colesevelam|Treatment with colesevelam in addition to metformin and diet
10978857|NCT00951899|FG001|Participant Flow|Placebo|Placebo plus diet and metformin
10978858|NCT00951899|OG000|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
10978859|NCT00951899|OG001|Outcome|Placebo|Placebo plus diet and metformin
10978860|NCT00951899|EG000|Reported Event|Colesevelam|Treatment with colesevelam in addition to metformin and diet
10978861|NCT00951899|EG001|Reported Event|Placebo|Placebo plus diet and metformin
10978862|NCT00951912|BG000|Baseline|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
10978863|NCT00951912|BG001|Baseline|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
10978864|NCT00951912|BG002|Baseline|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
10978865|NCT00951912|BG003|Baseline|Total|Total of all reporting groups
10978866|NCT00951912|FG000|Participant Flow|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
10978867|NCT00951912|FG001|Participant Flow|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
10978868|NCT00951912|FG002|Participant Flow|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
10978869|NCT00951912|OG000|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
10978870|NCT00951912|OG001|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
10978871|NCT00951912|OG002|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
10978872|NCT00951912|EG000|Reported Event|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
10978873|NCT00951912|EG001|Reported Event|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
10978874|NCT00951912|EG002|Reported Event|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
10978875|NCT00952068|BG000|Baseline|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
10978876|NCT00952068|FG000|Participant Flow|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
10978877|NCT00952068|OG000|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
10978878|NCT00952068|EG000|Reported Event|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
10978879|NCT00952081|BG000|Baseline|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
10978880|NCT00952081|FG000|Participant Flow|Clevidipine,Brain Tumor,Hypertension|Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.
10978881|NCT00952081|OG000|Outcome|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
10978882|NCT00952081|EG000|Reported Event|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
10978883|NCT00952120|BG000|Baseline|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
10978884|NCT00952120|BG001|Baseline|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
10978885|NCT00952120|BG002|Baseline|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
10978886|NCT00952120|BG003|Baseline|Total|Total of all reporting groups
10978887|NCT00952120|FG000|Participant Flow|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
10978888|NCT00952120|FG001|Participant Flow|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
10978889|NCT00952120|FG002|Participant Flow|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
10978890|NCT00952120|OG000|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
10978891|NCT00952120|OG001|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
10978892|NCT00952120|EG000|Reported Event|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
10978893|NCT00952120|EG001|Reported Event|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
10978894|NCT00952133|BG000|Baseline|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
10978895|NCT00952133|BG001|Baseline|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
10978896|NCT00952133|BG002|Baseline|Total|Total of all reporting groups
10978897|NCT00952133|FG000|Participant Flow|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
10978898|NCT00952133|FG001|Participant Flow|Palonosetron With Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
10978899|NCT00952133|OG000|Outcome|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
10978900|NCT00952133|OG001|Outcome|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
10848610|NCT00290706|BG001|Baseline|Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10978901|NCT00952133|OG000|Outcome|Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
10978902|NCT00952133|OG001|Outcome|Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
10978903|NCT00952133|EG000|Reported Event|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
10978904|NCT00952133|EG001|Reported Event|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
10978905|NCT00952211|BG000|Baseline|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
10978906|NCT00952211|BG001|Baseline|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
10978907|NCT00952211|BG002|Baseline|Total|Total of all reporting groups
10978908|NCT00952211|FG000|Participant Flow|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
10978909|NCT00952211|FG001|Participant Flow|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
10978910|NCT00952211|OG000|Outcome|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
10978911|NCT00952211|OG001|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
10978912|NCT00952211|EG000|Reported Event|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
10978913|NCT00952211|EG001|Reported Event|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
10978914|NCT00952276|BG000|Baseline|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
10978915|NCT00952276|BG001|Baseline|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
10978916|NCT00952276|BG002|Baseline|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
10978917|NCT00952276|BG003|Baseline|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
10978918|NCT00952276|BG004|Baseline|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
10978919|NCT00952276|BG005|Baseline|Total|Total of all reporting groups
10978920|NCT00952276|FG000|Participant Flow|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
10978921|NCT00952276|FG001|Participant Flow|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
10978922|NCT00952276|FG002|Participant Flow|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
10978923|NCT00952276|FG003|Participant Flow|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
10978924|NCT00952276|FG004|Participant Flow|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
10978925|NCT00952276|OG000|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
10848611|NCT00290706|BG002|Baseline|Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D8|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10978926|NCT00952276|OG001|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
10978927|NCT00952276|OG002|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
10978928|NCT00952276|OG003|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
10978929|NCT00952276|OG004|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
10978930|NCT00952276|EG000|Reported Event|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
10978931|NCT00952276|EG001|Reported Event|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
10978932|NCT00952276|EG002|Reported Event|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
10978933|NCT00952276|EG003|Reported Event|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
10978934|NCT00952276|EG004|Reported Event|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
10978935|NCT00952289|BG000|Baseline|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
10978936|NCT00952289|BG001|Baseline|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
10978937|NCT00952289|BG002|Baseline|Total|Total of all reporting groups
10978938|NCT00952289|FG000|Participant Flow|Ruxolitinib|Participants received ruxolitinib orally twice a day. The starting dose was based on Baseline platelet count. Patients with Baseline platelet count > 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
10978939|NCT00952289|FG001|Participant Flow|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
10978940|NCT00952289|OG000|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
10978941|NCT00952289|OG001|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
10978942|NCT00952289|EG000|Reported Event|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
10978943|NCT00952289|EG001|Reported Event|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
10978944|NCT00952315|BG000|Baseline|Stonebreaker|"Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.~Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented."
10978945|NCT00952315|BG001|Baseline|Lithoclast Select|"Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.~Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented"
10978946|NCT00952315|BG002|Baseline|Cyberwand|"The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.~Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented."
10978947|NCT00952315|BG003|Baseline|Total|Total of all reporting groups
10978948|NCT00952315|FG000|Participant Flow|Stonebreaker|"Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.~Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented."
10978949|NCT00952315|FG001|Participant Flow|Lithoclast Select|"Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.~Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented"
10978950|NCT00952315|FG002|Participant Flow|Cyberwand|"The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.~Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented."
10978951|NCT00952315|OG000|Outcome|Stonebreaker|"Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.~Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented."
10978952|NCT00952315|OG001|Outcome|Lithoclast Select|"Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.~Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented"
10978953|NCT00952315|OG002|Outcome|Cyberwand|"The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.~Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented."
10978954|NCT00952315|OG000|Outcome|Stonebreaker|Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
10848612|NCT00290706|BG003|Baseline|Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D15|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 15 of a 28 day Cycle for up to 8 cycles of treatment.
10978955|NCT00952315|OG001|Outcome|Lithoclast Select|Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.
10848613|NCT00290706|BG004|Baseline|Total|Total of all reporting groups
10978956|NCT00952315|OG002|Outcome|Cyberwand|Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
10978957|NCT00952315|EG000|Reported Event|Stonebreaker|"Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.~Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented."
10978958|NCT00952315|EG001|Reported Event|Lithoclast Select|"Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.~Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented"
10978959|NCT00952315|EG002|Reported Event|Cyberwand|"The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.~Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented."
10978960|NCT00952341|BG000|Baseline|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
10978961|NCT00952341|BG001|Baseline|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
10978962|NCT00952341|BG002|Baseline|Total|Total of all reporting groups
10978963|NCT00952341|FG000|Participant Flow|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
10978964|NCT00952341|FG001|Participant Flow|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
10978965|NCT00952341|OG000|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
10978966|NCT00952341|OG001|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
10978967|NCT00952341|EG000|Reported Event|Aprepitant (MK-0869), Cycle 1 & Cycle 2|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
10978968|NCT00952341|EG001|Reported Event|Placebo, Cycle 1 & Cycle 2|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
10978969|NCT00952367|BG000|Baseline|Per-protocol Population|In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
10978970|NCT00952367|FG000|Participant Flow|All Enrolled Participants|Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.
10978971|NCT00952367|OG000|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
10978972|NCT00952367|EG000|Reported Event|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
10978973|NCT00952380|BG000|Baseline|Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)|Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978974|NCT00952380|BG001|Baseline|Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)|Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978975|NCT00952380|BG002|Baseline|Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)|Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978976|NCT00952380|BG003|Baseline|Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)|Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978977|NCT00952380|BG004|Baseline|Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)|Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978978|NCT00952380|BG005|Baseline|Total|Total of all reporting groups
10978979|NCT00952380|FG000|Participant Flow|Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)|Participants aged greater than or equal to (>=) 0 to less than (<) 8 weeks were administered 125 international unit per kilogram (IU/kg) of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying venous thromboembolism (VTE). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978980|NCT00952380|FG001|Participant Flow|Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)|Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978981|NCT00952380|FG002|Participant Flow|Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)|Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978982|NCT00952380|FG003|Participant Flow|Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)|Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978983|NCT00952380|FG004|Participant Flow|Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)|Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10848614|NCT00290706|FG000|Participant Flow|Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.3 mg/m2|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.3 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848615|NCT00290706|FG001|Participant Flow|Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848616|NCT00290706|FG002|Participant Flow|Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D8|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848617|NCT00290706|FG003|Participant Flow|Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D15|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 15 of a 28 day Cycle for up to 8 cycles of treatment.
10848618|NCT00290706|OG000|Outcome|Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.3 mg/m2|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.3 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848619|NCT00290706|OG001|Outcome|Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848620|NCT00290706|OG002|Outcome|Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D8|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848621|NCT00290706|OG003|Outcome|Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D15|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 15 of a 28 day Cycle for up to 8 cycles of treatment.
10848622|NCT00290706|OG000|Outcome|Gemcitabine 800 mg/m2 + Bortezomib IVP Over 3-5 Seconds|"Gemcitabine dose of 800 mg/m2 over 30 minutes followed by Bortezomib IVP given over 3-5 seconds on either Day 1/Day 8 or Day 1/Day 15 of each cycle every 28 days for up to 8 cycles.~Bortezomib: Bortezomib either 1.3 mg/m2 or 1.6mg/m2 on either Day 1/Day 8 or Day 1/Day 15 of each cycle, given over 3-5 seconds every 28 days for up to 8 cycles.~Gemcitabine hydrochloride: Gemcitabine dose of 800 mg/m2 over 30 minutes on either Day 1/Day 8 or Day 1/Day 15 of each cycle every 28 days for up to 8 cycles."
10848623|NCT00290706|EG000|Reported Event|Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.3 mg/m2|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.3 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848624|NCT00290706|EG001|Reported Event|Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848625|NCT00290706|EG002|Reported Event|Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D8|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 8 of a 28 day Cycle for up to 8 cycles of treatment.
10848626|NCT00290706|EG003|Reported Event|Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D15|Patients are treated with Gemcitabine 800mg/m2 IV over 30 minutes and Bortezomib 1.6 mg/m2 IVP over 3-5 seconds on Day 1 and Day 15 of a 28 day Cycle for up to 8 cycles of treatment.
10848627|NCT00290732|BG000|Baseline|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
10848628|NCT00290732|BG001|Baseline|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
10848629|NCT00290732|BG002|Baseline|Total|Total of all reporting groups
10848630|NCT00290732|FG000|Participant Flow|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
10848631|NCT00290732|FG001|Participant Flow|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
10848632|NCT00290732|FG002|Participant Flow|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
10848633|NCT00290732|FG003|Participant Flow|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
10848634|NCT00290732|FG004|Participant Flow|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
10848635|NCT00290732|OG000|Outcome|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
10848636|NCT00290732|OG000|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
10848637|NCT00290732|OG001|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
10978984|NCT00952380|OG000|Outcome|Dalteparin Sodium: All Participants (>= 0 to < 19 Years)|All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978985|NCT00952380|OG000|Outcome|Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)|Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978986|NCT00952380|OG001|Outcome|Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)|Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978987|NCT00952380|OG002|Outcome|Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)|Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978988|NCT00952380|OG003|Outcome|Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)|Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978989|NCT00952380|OG004|Outcome|Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)|Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978990|NCT00952380|OG000|Outcome|Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)|Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978991|NCT00952380|OG001|Outcome|Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)|Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978992|NCT00952380|OG002|Outcome|Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)|Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978993|NCT00952380|OG003|Outcome|Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)|Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978994|NCT00952380|EG000|Reported Event|Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)|Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978995|NCT00952380|EG001|Reported Event|Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)|Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978996|NCT00952380|EG002|Reported Event|Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)|Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978997|NCT00952380|EG003|Reported Event|Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)|Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978998|NCT00952380|EG004|Reported Event|Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)|Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
10978999|NCT00952393|BG000|Baseline|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
10979000|NCT00952393|FG000|Participant Flow|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
10979001|NCT00952393|OG000|Outcome|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
10979002|NCT00952393|EG000|Reported Event|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
10979003|NCT00952419|BG000|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
10979004|NCT00952419|BG001|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
10979005|NCT00952419|BG002|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
10979006|NCT00952419|BG003|Baseline|Total|Total of all reporting groups
10979007|NCT00952419|FG000|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
10979008|NCT00952419|FG001|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
10979009|NCT00952419|FG002|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
10979010|NCT00952419|OG000|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
10979011|NCT00952419|OG001|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
10979012|NCT00952419|OG002|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
10979013|NCT00952419|EG000|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
10979014|NCT00952419|EG001|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
10979015|NCT00952419|EG002|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
10979016|NCT00952484|BG000|Baseline|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
10979017|NCT00952484|BG001|Baseline|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
10979018|NCT00952484|BG002|Baseline|Historical Control|De-identified historical controls selected from a natural history database of patients with HPP.
10979019|NCT00952484|BG003|Baseline|Total|Total of all reporting groups
10979020|NCT00952484|FG000|Participant Flow|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
10979021|NCT00952484|FG001|Participant Flow|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
10979022|NCT00952484|FG002|Participant Flow|Historical Control|"De-identified historical control patients (i.e., untreated with asfotase alfa) were selected from a longitudinal natural history database of patients with HPP maintained at Shriner's Hospitals for Children, St. Louis, Missouri.~Historical controls must have had at least two sets of wrist and knee radiographs taken between the ages of 5 years, 0 months and 12 years, 0 months with evidence of open growth plates."
10979023|NCT00952484|OG000|Outcome|Historical Controls|De-identified historical controls selected from a natural history database of patients with HPP.
10979024|NCT00952484|OG001|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
10979025|NCT00952484|OG000|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
10979026|NCT00952484|OG000|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
10979027|NCT00952484|OG001|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
10979028|NCT00952484|EG000|Reported Event|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
10979029|NCT00952484|EG001|Reported Event|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
10979030|NCT00952523|BG000|Baseline|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
10979031|NCT00952523|FG000|Participant Flow|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
10979032|NCT00952523|OG000|Outcome|Tretinoin Facial Gel|Tretinoin facial gel in a 0.04% Pump
10979033|NCT00952523|OG001|Outcome|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene 0.1% and Benzoyl peroxide 2.5%
10979034|NCT00952523|EG000|Reported Event|Tretinoin Facial Gel|Tretinoin facial gel applied once daily in a split face model
10979035|NCT00952523|EG001|Reported Event|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene-Benzoyl Peroxide facial gel applied once daily in a split face model
10979036|NCT00952588|BG000|Baseline|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
10979037|NCT00952588|BG001|Baseline|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
10979038|NCT00952588|BG002|Baseline|Total|Total of all reporting groups
10979039|NCT00952588|FG000|Participant Flow|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
10979040|NCT00952588|FG001|Participant Flow|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
10979041|NCT00952588|OG000|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
10979042|NCT00952588|OG001|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
10979043|NCT00952588|EG000|Reported Event|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
10979044|NCT00952588|EG001|Reported Event|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
10979045|NCT00952614|BG000|Baseline|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
10979046|NCT00952614|FG000|Participant Flow|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
10979047|NCT00952614|OG000|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide~Measure visual acuity improvement from baseline to time periods of 1,2, and 3 years."
10979048|NCT00952614|OG000|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
10979049|NCT00952614|EG000|Reported Event|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
10979050|NCT00952653|BG000|Baseline|DVS SR 50 mg, Midazolam 4 mg|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
10979051|NCT00952653|FG000|Participant Flow|DVS SR 50 mg, Midazolam 4 mg|Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter [mg/mL]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
10979052|NCT00952653|OG000|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
10979053|NCT00952653|OG001|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
10979054|NCT00952653|EG000|Reported Event|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
10979055|NCT00952653|EG001|Reported Event|DVS SR 50 mg (Period 2 / Day 1 to Day 5)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state).
10979056|NCT00952653|EG002|Reported Event|DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)|DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
10979057|NCT00952705|BG000|Baseline|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
10979058|NCT00952705|BG001|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
10979059|NCT00952705|BG002|Baseline|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
10979060|NCT00952705|BG003|Baseline|Total|Total of all reporting groups
10979061|NCT00952705|FG000|Participant Flow|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
10979062|NCT00952705|FG001|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
10873359|NCT00427778|OG001|Outcome|No Treatment|UDS done without ring. All patients had UDS done without the ring prior to entry into the study. This UDS was considered to reflect the 'no treatment' period, although technically it was done at baseline. A UDS during the 'no treatment' period would have been ideal, but this would have represented an additional UDS testing that likely would not have differed from the baseline testing. All patients needed to have UDS-proven urodynamic stress incontinence as inclusion criteria.
10873360|NCT00427778|OG000|Outcome|Incontinence Ring|UDS done with ring in place
10873361|NCT00427778|OG001|Outcome|no Treatment|All participants underwent UDS at baseline , when not wearing a ring. The flow rate obtained during this part of hte study is considered the 'no treatment' flow rate, irrespective of study arm.
10873362|NCT00427778|OG000|Outcome|Incontinence Ring Users|"Use of incontinence ring~incontinence ring (Milex): Incontinence ring fitted to patient's anatomy (by choosing appropriate size). It is worn continually for the duration of the treatment period.~Intravaginal incontinence ring placed proximally in the posterior vaginal fornix. Knob located at mid-urethra."
10873363|NCT00427778|OG001|Outcome|Controls|no intervention
10873364|NCT00427778|OG000|Outcome|Incontinence Ring|While wearing the incontinence ring,w omen were asked to fill out the VAS
10873365|NCT00427778|OG000|Outcome|Incontinence Ring Users|PVR done at UDS during uroflow while using ring
10873366|NCT00427778|OG001|Outcome|no Treatment|"PVR done at baseline UDS after uroflow. UDS was needed to determine baseline eligibility. We felt that this baseline UDS was representative of the no treatment' UDS and therefore considered as such. Doing a third UDs during the no treatment period per se was deemed unnecessary and subjected patient to redundant testing."
10873367|NCT00427778|EG000|Reported Event|Incontinence Ring|"Use of incontinence ring~incontinence ring (Milex): Incontinence ring fitted to patient's anatomy (by choosing appropriate size). It is worn continually for the duration of the treatment period.~Intravaginal incontinence ring placed proximally in the posterior vaginal fornix. Knob located at mid-urethra."
10873368|NCT00427778|EG001|Reported Event|No Treatment|no intervention
10873369|NCT00427791|BG000|Baseline|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
10873370|NCT00427791|BG001|Baseline|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
10873371|NCT00427791|BG002|Baseline|Total|Total of all reporting groups
10873372|NCT00427791|FG000|Participant Flow|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
10873373|NCT00427791|FG001|Participant Flow|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
10873374|NCT00427791|OG000|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
10873375|NCT00427791|OG001|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
10873376|NCT00427791|EG000|Reported Event|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
10873377|NCT00427791|EG001|Reported Event|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
10873378|NCT00427804|BG000|Baseline|Healthy Control|
10873379|NCT00427804|BG001|Baseline|Crohn's Disease|Subjects with stable Crohn's disease
10873380|NCT00427804|BG002|Baseline|Total|Total of all reporting groups
10873381|NCT00427804|FG000|Participant Flow|Healthy Control|
10873382|NCT00427804|FG001|Participant Flow|Crohn's Disease|Subjects with stable Crohn's disease
10873383|NCT00427804|OG000|Outcome|Healthy Control|
10873384|NCT00427804|OG001|Outcome|Crohn's Disease|Subjects with stable Crohn's disease
10873385|NCT00427804|EG000|Reported Event|Healthy Control|
10873386|NCT00427804|EG001|Reported Event|Crohn's Disease|Subjects with stable Crohn's disease
10873387|NCT00427895|BG000|Baseline|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
10873388|NCT00427895|BG001|Baseline|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
10873389|NCT00427895|BG002|Baseline|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
10873390|NCT00427895|BG003|Baseline|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
10873391|NCT00427895|BG004|Baseline|Total|Total of all reporting groups
10873392|NCT00427895|FG000|Participant Flow|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at baseline.
10873393|NCT00427895|FG001|Participant Flow|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
10873394|NCT00427895|FG002|Participant Flow|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.
10873395|NCT00427895|FG003|Participant Flow|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
10873396|NCT00427895|FG004|Participant Flow|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
10873397|NCT00427895|FG005|Participant Flow|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
10979063|NCT00952705|FG002|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
10979064|NCT00952705|OG000|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
10979065|NCT00952705|OG001|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
10979066|NCT00952705|OG002|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
10979067|NCT00952705|OG003|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
10979068|NCT00952705|OG001|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
10979069|NCT00952705|OG001|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
10979070|NCT00952705|OG001|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
10979071|NCT00952705|OG001|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
10979072|NCT00952705|EG000|Reported Event|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
10979073|NCT00952705|EG001|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
10979074|NCT00952718|BG000|Baseline|Inspiratory Muscle Training|"With intervention.~Inspiratory muscle training: A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks."
10848638|NCT00290732|OG002|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
10979075|NCT00952718|BG001|Baseline|Control|No intervention.
10979076|NCT00952718|BG002|Baseline|Total|Total of all reporting groups
10979077|NCT00952718|FG000|Participant Flow|Control|No intervention.
10979078|NCT00952718|FG001|Participant Flow|Inspiratory Muscle Training|"With intervention.~Inspiratory muscle training: A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks."
10979079|NCT00952718|OG000|Outcome|Inspiratory Muscle Training|"With intervention.~Inspiratory muscle training: A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks."
10979080|NCT00952718|OG001|Outcome|Control|No intervention.
10979081|NCT00952718|OG000|Outcome|Control|No intervention.
10979082|NCT00952718|OG001|Outcome|Inspiratory Muscle Training|"With intervention.~Inspiratory muscle training: A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks."
10979083|NCT00952718|EG000|Reported Event|Control|No intervention.
11098957|NCT01579045|EG004|Reported Event|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
10979084|NCT00952718|EG001|Reported Event|Inspiratory Muscle Training|"With intervention.~Inspiratory muscle training: A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks."
10979085|NCT00952731|BG000|Baseline|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
10979086|NCT00952731|BG001|Baseline|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
10979087|NCT00952731|BG002|Baseline|Total|Total of all reporting groups
10979088|NCT00952731|FG000|Participant Flow|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
10979089|NCT00952731|FG001|Participant Flow|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
10979090|NCT00952731|OG000|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
10979091|NCT00952731|OG001|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
10979092|NCT00952731|EG000|Reported Event|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
10979093|NCT00952731|EG001|Reported Event|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
10979094|NCT00952822|BG000|Baseline|Treated Participants|Participants who received at least 1 infusion
10979095|NCT00952822|FG000|Participant Flow|Adolescents/Adults - 2 mL Then 5 mL|Adolescents/Adults - 2 mL then 5 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
10979096|NCT00952822|FG001|Participant Flow|Adolescents/Adults - 5 mL Then 2 mL|Adolescents/Adults - 5 mL then 2 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
10979097|NCT00952822|FG002|Participant Flow|Pediatrics - 2 mL Then 5 mL|Pediatrics - 2 mL then 5 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
10848639|NCT00290732|OG003|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
10979098|NCT00952822|FG003|Participant Flow|Pediatrics - 5 mL Then 2 mL|Pediatrics - 5 mL then 2 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
10979099|NCT00952822|OG000|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
10979100|NCT00952822|OG001|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
10979101|NCT00952822|OG002|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
10979102|NCT00952822|OG003|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
10979103|NCT00952822|OG001|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=26)
10979104|NCT00952822|OG002|Outcome|Pediatrics at Least 5 Years of Age - 2 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI (note: 6 hours after infusion n=7)
10979105|NCT00952822|OG003|Outcome|Pediatrics at Least 5 Years of Age - 5 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=7)
10979106|NCT00952822|EG000|Reported Event|Adolescents/Adults|Participants aged ≥12 to ≤65 years who received at least one infusion
10979107|NCT00952822|EG001|Reported Event|Pediatrics|Participants aged ≥12 to ≤65 years who received at least one infusion
10979108|NCT00952848|BG000|Baseline|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
10979109|NCT00952848|FG000|Participant Flow|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
10979110|NCT00952848|OG000|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
10979111|NCT00952848|EG000|Reported Event|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
10979112|NCT00953017|BG000|Baseline|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979113|NCT00953017|BG001|Baseline|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979114|NCT00953017|BG002|Baseline|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979115|NCT00953017|BG003|Baseline|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
10979116|NCT00953017|BG004|Baseline|Total|Total of all reporting groups
10979117|NCT00953017|FG000|Participant Flow|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979118|NCT00953017|FG001|Participant Flow|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979119|NCT00953017|FG002|Participant Flow|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979120|NCT00953017|FG003|Participant Flow|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
10979121|NCT00953017|OG000|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979122|NCT00953017|OG001|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979123|NCT00953017|OG002|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979124|NCT00953017|OG003|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
10979125|NCT00953017|EG000|Reported Event|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979126|NCT00953017|EG001|Reported Event|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979127|NCT00953017|EG002|Reported Event|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
10979128|NCT00953017|EG003|Reported Event|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
10979129|NCT00953043|BG000|Baseline|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
10979130|NCT00953043|BG001|Baseline|Placebo|Subjects randomized to this arm received placebo medication for three days.
10979131|NCT00953043|BG002|Baseline|Total|Total of all reporting groups
10979132|NCT00953043|FG000|Participant Flow|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
10979133|NCT00953043|FG001|Participant Flow|Placebo|Subjects randomized to this arm received placebo medication for three days.
10979134|NCT00953043|OG000|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
10979135|NCT00953043|OG001|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
10979136|NCT00953043|EG000|Reported Event|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
10979137|NCT00953043|EG001|Reported Event|Placebo|Subjects randomized to this arm received placebo medication for three days.
10979138|NCT00953056|BG000|Baseline|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
10979139|NCT00953056|BG001|Baseline|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
10979140|NCT00953056|BG002|Baseline|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
10979141|NCT00953056|BG003|Baseline|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
10979142|NCT00953056|BG004|Baseline|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
10979143|NCT00953056|BG005|Baseline|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
10979144|NCT00953056|BG006|Baseline|Total|Total of all reporting groups
10979145|NCT00953056|FG000|Participant Flow|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
10979146|NCT00953056|FG001|Participant Flow|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
10979147|NCT00953056|FG002|Participant Flow|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
10979148|NCT00953056|FG003|Participant Flow|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
10979149|NCT00953056|FG004|Participant Flow|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
10979150|NCT00953056|FG005|Participant Flow|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
10979151|NCT00953056|OG000|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
10979152|NCT00953056|OG001|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
10979153|NCT00953056|OG002|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
10979154|NCT00953056|OG003|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
10979155|NCT00953056|OG004|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
10979156|NCT00953056|OG005|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
10979157|NCT00953056|OG000|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
10979158|NCT00953056|OG001|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
10979159|NCT00953056|EG000|Reported Event|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
10979160|NCT00953056|EG001|Reported Event|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
10979161|NCT00953056|EG002|Reported Event|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
10979162|NCT00953056|EG003|Reported Event|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
10979163|NCT00953056|EG004|Reported Event|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
10979164|NCT00953056|EG005|Reported Event|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
10979165|NCT00953121|BG000|Baseline|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979166|NCT00953121|BG001|Baseline|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979167|NCT00953121|BG002|Baseline|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979168|NCT00953121|BG003|Baseline|Total|Total of all reporting groups
10979169|NCT00953121|FG000|Participant Flow|Grade IV, No Bevacizumab Failure|"Recurrent Glioblastoma Multiforme (GBM) patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an area under the curve (AUC) of 4."
10979170|NCT00953121|FG001|Participant Flow|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979171|NCT00953121|FG002|Participant Flow|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979172|NCT00953121|OG000|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979173|NCT00953121|OG001|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979174|NCT00953121|OG002|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979175|NCT00953121|EG000|Reported Event|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979176|NCT00953121|EG001|Reported Event|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979177|NCT00953121|EG002|Reported Event|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
10979178|NCT00953147|BG000|Baseline|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
10979179|NCT00953147|BG001|Baseline|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
10979180|NCT00953147|BG002|Baseline|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
10979181|NCT00953147|BG003|Baseline|Total|Total of all reporting groups
10979182|NCT00953147|FG000|Participant Flow|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
10979183|NCT00953147|FG001|Participant Flow|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
10979184|NCT00953147|FG002|Participant Flow|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
10979185|NCT00953147|OG000|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
10979186|NCT00953147|OG001|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
10979187|NCT00953147|OG002|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
10979188|NCT00953147|EG000|Reported Event|Ciclesonide HFA 80 Mcg Once Daily|
10979189|NCT00953147|EG001|Reported Event|Ciclesonide HFA 160 Mcg Once Daily|
10979190|NCT00953147|EG002|Reported Event|Placebo Once Daily|
10979191|NCT00953160|BG000|Baseline|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
10979192|NCT00953160|FG000|Participant Flow|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
10979193|NCT00953160|OG000|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
10979194|NCT00953160|EG000|Reported Event|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
10979195|NCT00953173|BG000|Baseline|LapBand|"Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System~LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption."
10979196|NCT00953173|FG000|Participant Flow|LapBand|"Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System~LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption."
10979197|NCT00953173|OG000|Outcome|LapBand|"Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System~LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption."
10979198|NCT00953173|EG000|Reported Event|LapBand|"Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System~LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption."
10979199|NCT00953199|BG000|Baseline|Lidocaine|Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
10979200|NCT00953199|BG001|Baseline|Normal Saline|Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
10979201|NCT00953199|BG002|Baseline|Total|Total of all reporting groups
10979202|NCT00953199|FG000|Participant Flow|Lidocaine|Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
10979203|NCT00953199|FG001|Participant Flow|Normal Saline|Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
10979204|NCT00953199|OG000|Outcome|Lidocaine|Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
10979205|NCT00953199|OG001|Outcome|Normal Saline|Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
10979206|NCT00953199|OG000|Outcome|Lidocaine|"Study subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2%~Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine."
10979207|NCT00953199|OG001|Outcome|Normal Saline|"The control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.~Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care)."
10979208|NCT00953199|EG000|Reported Event|Lidocaine|Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
10979209|NCT00953199|EG001|Reported Event|Normal Saline|Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
10979210|NCT00953212|BG000|Baseline|Group A|"Beta Blockers, Ascorbic Acid and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
10979211|NCT00953212|BG001|Baseline|Group B|"Beta Blockers and Ascorbic Acid~beta blockers: metoprolol 25mg by mouth every 6 hours~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
10979212|NCT00953212|BG002|Baseline|Group C|"Beta Blockers and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively"
10979213|NCT00953212|BG003|Baseline|Group D|"Beta Blockers alone~beta blockers: metoprolol 25mg by mouth every 6 hours"
10979214|NCT00953212|BG004|Baseline|Total|Total of all reporting groups
10979215|NCT00953212|FG000|Participant Flow|Beta Blockers, Ascorbic Acid and Amiodarone|"beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
10979216|NCT00953212|FG001|Participant Flow|Beta Blockers and Ascorbic Acid|"Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
10979217|NCT00953212|FG002|Participant Flow|Beta Blockers and Amiodarone|"Beta Blockers and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively"
10979218|NCT00953212|FG003|Participant Flow|Beta Blockers Alone|"Beta Blockers alone~beta blockers: metoprolol 25mg by mouth every 6 hours"
10979219|NCT00953212|OG000|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
10979220|NCT00953212|OG001|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
10979221|NCT00953212|OG002|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
10979222|NCT00953212|OG003|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
10979223|NCT00953212|OG000|Outcome|Beta Blockers, Ascorbic Acid and Amiodarone|"beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
10979224|NCT00953212|OG001|Outcome|Beta Blockers and Ascorbic Acid|"Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
10979225|NCT00953212|OG002|Outcome|Beta Blockers and Amiodarone|"Beta Blockers and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively"
10979226|NCT00953212|OG003|Outcome|Beta Blockers Alone|"Beta Blockers alone~beta blockers: metoprolol 25mg by mouth every 6 hours"
10979227|NCT00953212|EG000|Reported Event|Group A|"Beta Blockers, Ascorbic Acid and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
10979228|NCT00953212|EG001|Reported Event|Group B|"Beta Blockers and Ascorbic Acid~beta blockers: metoprolol 25mg by mouth every 6 hours~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
10979229|NCT00953212|EG002|Reported Event|Group C|"Beta Blockers and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively"
10979230|NCT00953212|EG003|Reported Event|Group D|"Beta Blockers alone~beta blockers: metoprolol 25mg by mouth every 6 hours"
10979231|NCT00953225|BG000|Baseline|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
10979232|NCT00953225|BG001|Baseline|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
10979233|NCT00953225|BG002|Baseline|Total|Total of all reporting groups
10979234|NCT00953225|FG000|Participant Flow|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
10979235|NCT00953225|FG001|Participant Flow|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
10979236|NCT00953225|OG000|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
10979237|NCT00953225|OG001|Outcome|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
10979238|NCT00953225|EG000|Reported Event|Arm 1|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
10979239|NCT00953225|EG001|Reported Event|Arm 2|"Placebo daily for one year~Placebo daily for one year: Placebo"
10979240|NCT00953290|BG000|Baseline|Treated And Untreated Thigh|Treated and untreated arms (left and right thighs) on the same subject.
10979241|NCT00953290|FG000|Participant Flow|Treated and Untreated Thigh|Circumference measurement of RF treated thigh compared to untreated thigh (average of 2.8 treatments and average dosage of 27 kJ) on the same subject
10979242|NCT00953290|OG000|Outcome|Treated and Untreated Upper Thigh|Treated and untreated arms (left and right thigh) on the same participant
10979243|NCT00953290|OG000|Outcome|Treated and Untreated Thigh|
10979244|NCT00953290|OG000|Outcome|Treated Thigh|
10979245|NCT00953290|OG000|Outcome|Treated and Untreated Mid Thigh|Treated and untreated arms (left and right thigh) on the same subject
10979246|NCT00953290|EG000|Reported Event|Treated Thigh|
10979247|NCT00953407|BG000|Baseline|Nelfilcon A|Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis
10979248|NCT00953407|BG001|Baseline|Narafilcon A|Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis
10979249|NCT00953407|BG002|Baseline|Etafilcon A|Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis
10979250|NCT00953407|BG003|Baseline|Omafilcon A|Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis
10979251|NCT00953407|BG004|Baseline|Hilafilcon B|Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis
10979252|NCT00953407|BG005|Baseline|Total|Total of all reporting groups
10979253|NCT00953407|FG000|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
10979254|NCT00953407|FG001|Participant Flow|Narafilcon A|Narafilcon A contact lens
10979255|NCT00953407|FG002|Participant Flow|Etafilcon A|Etafilcon A contact lens
10979256|NCT00953407|FG003|Participant Flow|Omafilcon A|Omafilcon A contact lens
10979257|NCT00953407|FG004|Participant Flow|Hilafilcon B|Hilafilcon B contact lens
10979258|NCT00953407|OG000|Outcome|Nelfilcon A|Nelfilcon A contact lens
10979259|NCT00953407|OG001|Outcome|Narafilcon A|Narafilcon A contact lens
10979260|NCT00953407|OG002|Outcome|Etafilcon A|Etafilcon A contact lens
10979261|NCT00953407|OG003|Outcome|Omafilcon A|Omafilcon A contact lens
10979262|NCT00953407|OG004|Outcome|Hilafilcon B|Hilafilcon B contact lens
10979263|NCT00953407|EG000|Reported Event|Nelfilcon A|Nelfilcon A contact lens
10979264|NCT00953407|EG001|Reported Event|Narafilcon A|Narafilcon A contact lens
10979265|NCT00953407|EG002|Reported Event|Etafilcon A|Etafilcon A contact lens
10979266|NCT00953407|EG003|Reported Event|Omafilcon A|Omafilcon A contact lens
10979267|NCT00953407|EG004|Reported Event|Hilafilcon B|Hilafilcon B contact lens
10979268|NCT00953524|BG000|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
10979269|NCT00953524|BG001|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
10979270|NCT00953524|BG002|Baseline|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
10979271|NCT00953524|BG003|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
10979272|NCT00953524|BG004|Baseline|Total|Total of all reporting groups
10979273|NCT00953524|FG000|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
10979274|NCT00953524|FG001|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
10979275|NCT00953524|FG002|Participant Flow|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
10979276|NCT00953524|FG003|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
10979277|NCT00953524|OG000|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
10979278|NCT00953524|OG001|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
10979279|NCT00953524|OG002|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
10979280|NCT00953524|OG003|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
10979281|NCT00953524|EG000|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
10979282|NCT00953524|EG001|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
10979283|NCT00953524|EG002|Reported Event|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
10979284|NCT00953524|EG003|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
10979285|NCT00953576|BG000|Baseline|Phase I Dose Level 1: KHAD+L (250 mg)|"For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979286|NCT00953576|BG001|Baseline|Phase I Dose Level 2: KHAD+L (500 mg)|"For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979287|NCT00953576|BG002|Baseline|Total|Total of all reporting groups
10979288|NCT00953576|FG000|Participant Flow|Phase I Dose Level 1: KHAD+L (250 mg)|"For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979289|NCT00953576|FG001|Participant Flow|Phase I Dose Level 2: KHAD+L (500 mg)|"For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979290|NCT00953576|OG000|Outcome|All Phase I Participants KHAD+L|"For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: orally 1x day according to the established dose escalation schedule~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979291|NCT00953576|OG000|Outcome|Phase I Dose Level 1: KHAD+L (250 mg)|"For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979292|NCT00953576|OG001|Outcome|Phase I Dose Level 2: KHAD+L (500 mg)|"For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979293|NCT00953576|OG000|Outcome|Phase I Dose Level 1: KHAD+L (250 mg)|"For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.~For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979294|NCT00953576|OG001|Outcome|Phase I Dose Level 2: KHAD+L (500 mg)|"For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day"
10979295|NCT00953576|EG000|Reported Event|Phase I Dose Level 1: KHAD+L (250 mg)|"For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10848640|NCT00290732|OG004|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
10848641|NCT00290732|EG000|Reported Event|Intraductal Arm- 0 mg PLD|
10979296|NCT00953576|EG001|Reported Event|Phase I Dose Level 2: KHAD+L (500 mg)|"For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal."
10979297|NCT00953654|BG000|Baseline|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
10979298|NCT00953654|BG001|Baseline|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
10979299|NCT00953654|BG002|Baseline|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
10979300|NCT00953654|BG003|Baseline|Total|Total of all reporting groups
10979301|NCT00953654|FG000|Participant Flow|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
10979302|NCT00953654|FG001|Participant Flow|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
10979303|NCT00953654|FG002|Participant Flow|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
10979304|NCT00953654|OG000|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
10979305|NCT00953654|OG001|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
10979306|NCT00953654|OG002|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
10979307|NCT00953654|EG000|Reported Event|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
10979308|NCT00953654|EG001|Reported Event|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
10979309|NCT00953654|EG002|Reported Event|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
10848642|NCT00290732|EG001|Reported Event|Intraductal Arm- 2 mg PLD|
10979310|NCT00953667|BG000|Baseline|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
10979311|NCT00953667|FG000|Participant Flow|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
10979312|NCT00953667|OG000|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
10979313|NCT00953667|EG000|Reported Event|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
10979314|NCT00953706|BG000|Baseline|Placebo - Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
10979315|NCT00953706|BG001|Baseline|Ivacaftor - Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
10979316|NCT00953706|BG002|Baseline|Total|Total of all reporting groups
10979317|NCT00953706|FG000|Participant Flow|Placebo - Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
10979318|NCT00953706|FG001|Participant Flow|Ivacaftor - Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
10979319|NCT00953706|FG002|Participant Flow|Placebo/Ivacaftor - Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
10979320|NCT00953706|FG003|Participant Flow|Ivacaftor/Ivacaftor - Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
10979321|NCT00953706|OG000|Outcome|Placebo - Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
10979322|NCT00953706|OG001|Outcome|Ivacaftor - Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
10979323|NCT00953706|OG000|Outcome|Placebo/Ivacaftor - Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
10848643|NCT00290732|EG002|Reported Event|Intraductal Arm- 5 mg PLD|
10848644|NCT00290732|EG003|Reported Event|Intraductal Arm- 10 mg PLD|
10848645|NCT00290732|EG004|Reported Event|Intravenous Arm|Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.
10979324|NCT00953706|OG001|Outcome|Ivacaftor/Ivacaftor - Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
10979325|NCT00953706|EG000|Reported Event|Placebo - Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
10979326|NCT00953706|EG001|Reported Event|Ivacaftor - Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
10979327|NCT00953706|EG002|Reported Event|Placebo/Ivacaftor - Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
10979328|NCT00953706|EG003|Reported Event|Ivacaftor/Ivacaftor - Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
10979329|NCT00953719|BG000|Baseline|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
10979330|NCT00953719|BG001|Baseline|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
10979331|NCT00953719|BG002|Baseline|Total|Total of all reporting groups
10979332|NCT00953719|FG000|Participant Flow|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
10979333|NCT00953719|FG001|Participant Flow|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
10979334|NCT00953719|OG000|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
10979335|NCT00953719|OG001|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
10979336|NCT00953719|EG000|Reported Event|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
10848646|NCT00290745|BG000|Baseline|Tamoxifen or Letrozole|"tamoxifen or letrozole work in treating women with ductal carcinoma in situ~letrozole~tamoxifen citrate~conventional surgery~neoadjuvant therapy"
10979337|NCT00953719|EG001|Reported Event|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
10979338|NCT00953745|BG000|Baseline|Depressed Participants|"Subjects with treatment-resistant depression (TRD) will receive escitalopram combined with an adjunctive placebo capsule for 8 weeks.~Subjects who fail to respond will continue to receive escitalopram and additionally change to receive a placebo tablet resembling the active augmentation agent Aripiprazole (ARP) for 2 weeks.~Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP.~Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment."
10979339|NCT00953745|BG001|Baseline|Control Participants|Non-depressed, age- and sex-matched subjects without a DSM-IV Axis I diagnosis will serve as controls. They will not receive antidepressant, ARP, or any drug augmentation and will be used to compare the pre-ARP and post-ARP treatment brain images to draw conclusions about the pre-treatment state (depression) and post-treatment state (depression responders).
10979340|NCT00953745|BG002|Baseline|Total|Total of all reporting groups
10979341|NCT00953745|FG000|Participant Flow|Depressed Participants|"Subjects with treatment-resistant depression (TRD) will receive escitalopram combined with an adjunctive placebo capsule for 8 weeks.~Subjects who fail to respond will continue to receive escitalopram and additionally change to receive a placebo tablet resembling the active augmentation agent Aripiprazole (ARP) for 2 weeks."
10979342|NCT00953745|FG001|Participant Flow|Control Participants|Non-depressed, age- and sex-matched subjects without a DSM-IV Axis I diagnosis will serve as controls. They will not receive antidepressant, ARP, or any drug augmentation and will be used to compare the pre-ARP and post-ARP treatment brain images to draw conclusions about the pre-treatment state (depression) and post-treatment state (depression responders).
10979343|NCT00953745|OG000|Outcome|ARP Responders|"Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP. ARP Responders will have had a 50% or greater drop in their MADRS scores from baseline.~Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment."
10979344|NCT00953745|OG001|Outcome|ARP Non-Responders|"Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP. ARP Responders will have had a 50% or greater drop in their MADRS scores from baseline.~Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment."
10979345|NCT00953745|OG000|Outcome|ARP Responders|Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP. ARP Responders will have had a 50% or greater drop in their MADRS scores from baseline.
10979346|NCT00953745|OG001|Outcome|ARP Non-Responders|Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP. ARP non-responders will not have had a 50% or greater drop in their MADRS scores from baseline.
11098958|NCT01579084|BG000|Baseline|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
10873398|NCT00427895|FG006|Participant Flow|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
10873399|NCT00427895|FG007|Participant Flow|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
10873400|NCT00427895|OG000|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
10873401|NCT00427895|OG001|Outcome|23vPS/23vPS, Cohort 1|Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
10873402|NCT00427895|OG002|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
10873403|NCT00427895|OG003|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
10873404|NCT00427895|OG001|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
10873405|NCT00427895|OG002|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose of open-label 23vPS (Vaccination 2) at Year 3 to 4.
10873406|NCT00427895|OG000|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
10873407|NCT00427895|OG001|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
10873408|NCT00427895|OG002|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1).
10873409|NCT00427895|OG003|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
10873410|NCT00427895|OG000|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
10873411|NCT00427895|OG002|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
10873412|NCT00427895|OG002|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
10873413|NCT00427895|OG001|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
10873414|NCT00427895|OG002|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
10873415|NCT00427895|OG003|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
10873416|NCT00427895|OG001|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1).
10873417|NCT00427895|OG002|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1).
10873418|NCT00427895|OG000|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at Year 0.
10873419|NCT00427895|OG001|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1) at Year 0.
10873420|NCT00427895|OG002|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1) Year 0.
10873421|NCT00427895|EG000|Reported Event|13vPnC, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 [Vax1]), reported after vaccination.
10873422|NCT00427895|EG001|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
10873423|NCT00427895|EG002|Reported Event|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
10873424|NCT00427895|EG003|Reported Event|23vPS: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
10873425|NCT00427895|EG004|Reported Event|13vPnC, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
10873426|NCT00427895|EG005|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
10873427|NCT00427895|EG006|Reported Event|13vPnC/13vPnC, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
11098959|NCT01579084|BG001|Baseline|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
10979347|NCT00953745|EG000|Reported Event|Depressed Participants|"Subjects with treatment-resistant depression (TRD) will receive escitalopram combined with an adjunctive placebo capsule for 8 weeks.~Subjects who fail to respond will continue to receive escitalopram and additionally change to receive a placebo tablet resembling the active augmentation agent Aripiprazole (ARP) for 2 weeks.~Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP.~Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment."
10979348|NCT00953745|EG001|Reported Event|Control Participants|Non-depressed, age- and sex-matched subjects without a DSM-IV Axis I diagnosis will serve as controls. They will not receive antidepressant, ARP, or any drug augmentation and will be used to compare the pre-ARP and post-ARP treatment brain images to draw conclusions about the pre-treatment state (depression) and post-treatment state (depression responders).
10979349|NCT00953849|BG000|Baseline|Arm 1: Celecoxib|"Celecoxib:~Celecoxib (400 mg twice daily) oral cancer patients receiving new immunotherapy prior to surgery"
10979350|NCT00953849|BG001|Baseline|Arm 2: Calcitriol|Calcitriol Calcitriol (1,25-dihydroxyvitamin D3): 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment)
10979351|NCT00953849|BG002|Baseline|Arm 3: Celecoxib Plus Calcitriol|Celecoxib + Calcitriol 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg 1,25-dihydroxyvitamin D3) for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
10979352|NCT00953849|BG003|Baseline|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
10979353|NCT00953849|BG004|Baseline|Total|Total of all reporting groups
10979354|NCT00953849|FG000|Participant Flow|Arm 1: Celecoxib|Treatment with Celecoxib
10979355|NCT00953849|FG001|Participant Flow|Arm 2: Calcitriol|Treatment with Calcitriol
10979356|NCT00953849|FG002|Participant Flow|Arm 3: Celecoxib Plus Calcitriol|Treatment with Celecoxib + Calcitriol
10979357|NCT00953849|FG003|Participant Flow|Arm 4: No Treatment|no treatment prior to surgery
10979358|NCT00953849|OG000|Outcome|Arm 1: Celecoxib|"Celecoxib treatment prior to surgery~Celecoxib: Celecoxib (400 mg twice daily)"
10979359|NCT00953849|OG001|Outcome|Arm 2: Calcitriol|"Treatment with Calcitriol prior to surgery~Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment)"
10848647|NCT00290745|FG000|Participant Flow|Tamoxifen or Letrozole|"tamoxifen or letrozole work in treating women with ductal carcinoma in situ~letrozole~tamoxifen citrate~conventional surgery~neoadjuvant therapy"
10979360|NCT00953849|OG002|Outcome|Arm 3: Celecoxib Plus Calcitriol|"Treatment with Celecoxib plus Calcitriol prior to surgery.~Celecoxib plus Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)"
10979361|NCT00953849|OG003|Outcome|Arm 4: No Treatment|no treatment prior to surgery
10979362|NCT00953849|OG000|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
10979363|NCT00953849|OG001|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
10979364|NCT00953849|OG002|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
10979365|NCT00953849|OG003|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
10979366|NCT00953849|EG000|Reported Event|Arm 1: Celecoxib|oral cancer patients receiving Celecoxib prior to surgery
10979367|NCT00953849|EG001|Reported Event|Arm 2: Calcitriol|oral cancer patients receiving Calcitriol prior to surgery
10979368|NCT00953849|EG002|Reported Event|Arm 3: Celecoxib Plus Calcitriol|oral cancer patients receiving Celecoxib + Calcitriol prior to surgery
10979369|NCT00953849|EG003|Reported Event|Arm 4: No Treatment|oral cancer patients receiving no treatment prior to surgery
10979370|NCT00953862|BG000|Baseline|Treatment|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
10979371|NCT00953862|FG000|Participant Flow|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
11098960|NCT01579084|BG002|Baseline|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
10979372|NCT00953862|OG000|Outcome|Atomoxetine Arm|Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline. Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.
10979373|NCT00953862|OG000|Outcome|Atomoxetine Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
10979374|NCT00953862|OG000|Outcome|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
10979375|NCT00953862|EG000|Reported Event|Treatment Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
10979376|NCT00953927|BG000|Baseline|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
10979377|NCT00953927|BG001|Baseline|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
10979378|NCT00953927|BG002|Baseline|Total|Total of all reporting groups
10979379|NCT00953927|FG000|Participant Flow|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
10979380|NCT00953927|FG001|Participant Flow|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
10979381|NCT00953927|OG000|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
10979382|NCT00953927|OG001|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
10979383|NCT00953927|EG000|Reported Event|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
10979384|NCT00953927|EG001|Reported Event|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
10979385|NCT00954109|BG000|Baseline|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
10979386|NCT00954109|FG000|Participant Flow|Exercise|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
10979387|NCT00954109|OG000|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
10979388|NCT00954109|EG000|Reported Event|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
10979389|NCT00954122|BG000|Baseline|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
10979390|NCT00954122|FG000|Participant Flow|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
10979391|NCT00954122|OG000|Outcome|Quetiapine Fumarate XR|Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
10979392|NCT00954122|OG000|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
10979393|NCT00954122|EG000|Reported Event|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
10979394|NCT00954174|BG000|Baseline|Regimen I - Uterine Carcinsarcoma Subjects|Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979395|NCT00954174|BG001|Baseline|Regimen II - Uterine Carcinsarcoma Subjects|Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
10979396|NCT00954174|BG002|Baseline|Regimen III - Non-uterine Carcinsarcoma Subjects|Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979397|NCT00954174|BG003|Baseline|Regimen IV - Non-uterine Carcinsarcoma Subjects|Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
10979398|NCT00954174|BG004|Baseline|Total|Total of all reporting groups
10979399|NCT00954174|FG000|Participant Flow|Regimen I - Uterine Carcinsarcoma Subjects|Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979400|NCT00954174|FG001|Participant Flow|Regimen II - Uterine Carcinsarcoma Subjects|Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
10979401|NCT00954174|FG002|Participant Flow|Regimen III - Non-uterine Carcinsarcoma Subjects|Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979402|NCT00954174|FG003|Participant Flow|Regimen IV - Non-uterine Carcinsarcoma Subjects|Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
10979403|NCT00954174|OG000|Outcome|Regimen I- Uterine Carcinsarcoma Subjects|Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979404|NCT00954174|OG001|Outcome|Regimen II - Uterine Carcinsarcoma Subjects|Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
10979405|NCT00954174|OG000|Outcome|Regimen I - Uterine Carcinsarcoma Subjects|Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979406|NCT00954174|OG002|Outcome|Regimen III - Non-uterine Carcinsarcoma Subjects|Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979407|NCT00954174|OG003|Outcome|Regimen IV - Non-uterine Carcinsarcoma Subjects|Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
10979408|NCT00954174|OG000|Outcome|Regimen I - Uterine and Non-Uterine Subjects|Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979409|NCT00954174|OG001|Outcome|Regimen II - All Uterine and Non-Uterine Subjects|Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
10979410|NCT00954174|OG000|Outcome|Regimen I - Uterine and Non-Uterine Subjects|"Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.~Carboplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10979411|NCT00954174|OG001|Outcome|Regimen II - Uterine and Non-Uterine Subjects|"Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.~Ifosfamide: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10979412|NCT00954174|EG000|Reported Event|Regimen I - Uterine and Non-uterine Carcinosarcoma|Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
10979413|NCT00954174|EG001|Reported Event|Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects|Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
10979414|NCT00954356|BG000|Baseline|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
10979415|NCT00954356|BG001|Baseline|Placebo|5 x matching placebo capsules (administered as a single dose)
10979416|NCT00954356|BG002|Baseline|Total|Total of all reporting groups
10979417|NCT00954356|FG000|Participant Flow|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
10979418|NCT00954356|FG001|Participant Flow|Placebo|5 x matching placebo capsules (administered as a single dose)
10979419|NCT00954356|OG000|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
10979420|NCT00954356|OG001|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
10979421|NCT00954356|EG000|Reported Event|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
10979422|NCT00954356|EG001|Reported Event|Placebo|5 x matching placebo capsules (administered as a single dose)
10979423|NCT00954421|BG000|Baseline|All Subjects|All eligible subjects were enrolled and the intent was to treat for six months on dual lead deep brain stimulation in the VIM and VO regions.
10979424|NCT00954421|FG000|Participant Flow|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
10979425|NCT00954421|OG000|Outcome|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
10979426|NCT00954421|OG000|Outcome|TRS Scale Both Off vs Both on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Both OFF- Both On) at 6 months.~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
10979427|NCT00954421|OG001|Outcome|TRS Scale Vo Only on vs. Vim Only on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Vo only on -VM only on at 6 months.~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
10979428|NCT00954421|EG000|Reported Event|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
10979429|NCT00954447|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
10979430|NCT00954447|BG001|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
10979431|NCT00954447|BG002|Baseline|Total|Total of all reporting groups
10979432|NCT00954447|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
10979433|NCT00954447|FG001|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
10979434|NCT00954447|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
10979435|NCT00954447|OG001|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
10979436|NCT00954447|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
11098961|NCT01579084|BG003|Baseline|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10979437|NCT00954447|EG001|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
10979438|NCT00954512|BG000|Baseline|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
10979439|NCT00954512|BG001|Baseline|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
10979440|NCT00954512|BG002|Baseline|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
10979441|NCT00954512|BG003|Baseline|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
10979442|NCT00954512|BG004|Baseline|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
10979443|NCT00954512|BG005|Baseline|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
10979444|NCT00954512|BG006|Baseline|Total|Total of all reporting groups
10979445|NCT00954512|FG000|Participant Flow|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
10979446|NCT00954512|FG001|Participant Flow|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
10979447|NCT00954512|FG002|Participant Flow|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
10979448|NCT00954512|FG003|Participant Flow|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
10979449|NCT00954512|FG004|Participant Flow|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
10979450|NCT00954512|FG005|Participant Flow|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
10979451|NCT00954512|OG000|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
10979452|NCT00954512|OG001|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
10979453|NCT00954512|OG002|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
10979454|NCT00954512|OG003|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
10979455|NCT00954512|OG004|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
10979456|NCT00954512|OG005|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
10979457|NCT00954512|EG000|Reported Event|Regimen A: FOLFIRI (+/- Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 followed by once-weekly doses of 250 mg/m^2) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 2 weeks.
10979458|NCT00954512|EG001|Reported Event|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
10979459|NCT00954512|EG002|Reported Event|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
10979460|NCT00954512|EG003|Reported Event|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
10979461|NCT00954512|EG004|Reported Event|Regimen F: Gemcitabine (+/- Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 on Days 1, 8, 15, 22, 29, 36, and 43 (± erlotinib 100 mg per day) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 8 weeks.
10979462|NCT00954538|BG000|Baseline|Healthy Participants (Part I) + HE Participants (Part II/III)|This group includes Healthy participants (Part I) and HE participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
10979463|NCT00954538|BG001|Baseline|AD Participants (Part II/III)|This group includes AD participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of brain
10979464|NCT00954538|BG002|Baseline|Total|Total of all reporting groups
10979465|NCT00954538|FG000|Participant Flow|Healthy Participants (Part I Only)|Healthy participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by Positron Emission Tomography (PET) imaging of the whole body (Part I)
10979466|NCT00954538|FG001|Participant Flow|Healthy Elderly (HE) Participants (Part II Only)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
10979467|NCT00954538|FG002|Participant Flow|Alzheimer's Disease (AD) Participants (Part II Only)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
10979468|NCT00954538|FG003|Participant Flow|HE Participants (Part III Only)|HE participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
10979469|NCT00954538|FG004|Participant Flow|AD Participants (Part III Only)|AD participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
10979470|NCT00954538|FG005|Participant Flow|HE Participants (Part II + III)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II) / HE Participants who completed Part II could receive a second IV dose of ~150 MBq [18F]MK-3328 in Part III; this dose was followed by PET imaging of the brain
10979471|NCT00954538|OG000|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
10979472|NCT00954538|OG000|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
10979473|NCT00954538|OG000|Outcome|AD Participants (Part II)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
10979474|NCT00954538|OG001|Outcome|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
10979475|NCT00954538|OG000|Outcome|AD Participants (Part III)|AD participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
10979476|NCT00954538|OG001|Outcome|HE Participants (Part III)|HE participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
10979477|NCT00954538|EG000|Reported Event|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
10979478|NCT00954681|BG000|Baseline|Quetiapine Treatment|"Open label treatment with quetiapine~quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily"
10979479|NCT00954681|FG000|Participant Flow|Quetiapine Treatment|"Open label treatment with quetiapine~quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily"
10979480|NCT00954681|OG000|Outcome|Open-Label Quetiapine Treatment|Participants receiving quetiapine under open-label conditions.
10979481|NCT00954681|EG000|Reported Event|Quetiapine Treatment|"Open label treatment with quetiapine~quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily"
10979482|NCT00954707|BG000|Baseline|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
10979483|NCT00954707|FG000|Participant Flow|All Enrolled Subjects|Subjects signed the consent forms and met all protocol defined inclusion criteria and none of the exclusion criteria.
10979484|NCT00954707|OG000|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
10979485|NCT00954707|EG000|Reported Event|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
10979486|NCT00954733|BG000|Baseline|All Participants|All participants in the study
10979487|NCT00954733|FG000|Participant Flow|All Participants|All participants undergoing surgery
10979488|NCT00954733|OG000|Outcome|All Participants|All participants undergoing surgery
10979489|NCT00954733|EG000|Reported Event|All Participants|All participants undergoing surgery
10979490|NCT00954824|BG000|Baseline|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
10979491|NCT00954824|FG000|Participant Flow|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
10979492|NCT00954824|OG000|Outcome|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
10979493|NCT00954824|EG000|Reported Event|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
10979494|NCT00954941|BG000|Baseline|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
10979495|NCT00954941|BG001|Baseline|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
10979496|NCT00954941|BG002|Baseline|Total|Total of all reporting groups
10979497|NCT00954941|FG000|Participant Flow|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
10979498|NCT00954941|FG001|Participant Flow|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
10979499|NCT00954941|OG000|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
10979500|NCT00954941|OG001|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
10979501|NCT00954941|EG000|Reported Event|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
10979502|NCT00954941|EG001|Reported Event|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
10979503|NCT00954993|BG000|Baseline|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
10979504|NCT00954993|FG000|Participant Flow|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
10979505|NCT00954993|OG000|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
10979506|NCT00954993|OG001|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
10979507|NCT00954993|EG000|Reported Event|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
10979508|NCT00954993|EG001|Reported Event|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
10979509|NCT00955032|BG000|Baseline|rTMS Treatment|Participants in this group received rTMS treatment.
10979510|NCT00955032|BG001|Baseline|Sham Treatment|Participants in this group did not receive rTMS treatment.
10979511|NCT00955032|BG002|Baseline|Total|Total of all reporting groups
10979512|NCT00955032|FG000|Participant Flow|rTMS Treatment|Participants in this group received rTMS treatment.
10979513|NCT00955032|FG001|Participant Flow|Sham Treatment|Participants in this group did not receive rTMS treatment.
10979514|NCT00955032|OG000|Outcome|rTMS Pre TX|Participants in this group were assessed prior to rTMS treatment.
10979515|NCT00955032|OG001|Outcome|Sham Pre TX|Participants in this group were assessed before sham treatment.
10979516|NCT00955032|OG002|Outcome|rTMS Post TX (Immediate)|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
10979517|NCT00955032|OG003|Outcome|Sham Post Tx (Immediate)|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
10979518|NCT00955032|OG000|Outcome|rTMS Pre tx|Participants in this group received were assessed prior to receiving rTMS treatment.
10979519|NCT00955032|OG001|Outcome|Sham Pre tx|Participants in this group were assessed prior to receiving Sham treatment.
10979520|NCT00955032|OG002|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
10979521|NCT00955032|OG003|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
10979522|NCT00955032|OG000|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
10979523|NCT00955032|OG001|Outcome|Sham Pre tx|Participants in this group were assessed before they received Sham tx.
10979524|NCT00955032|OG001|Outcome|Sham Pre tx|Participants in this group were assessed before they received sham treatment.
10979525|NCT00955032|EG000|Reported Event|rTMS Treatment|Participants in this group received rTMS treatment.
10979526|NCT00955032|EG001|Reported Event|Sham Treatment|Participants in this group did not receive rTMS treatment.
10979527|NCT00955110|BG000|Baseline|All Subjects Randomized to Treatment Phase|Forty one (41) qualified subjects were randomized into the treatment phase (Randomized population). Subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.
10979528|NCT00955110|FG000|Participant Flow|All Subjects|"Subjects enrolled were healthy non-dependent recreational opioid users. During the Treatment Phase, subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.~All participants did not necessarily receive the 5 drug interventions in the order reported as Milestones."
10979529|NCT00955110|OG000|Outcome|Placebo|Subjects received a single oral dose (1 capsule) of placebo.
10979530|NCT00955110|OG001|Outcome|Oxymorphone ER 15 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 15 mg.
10979531|NCT00955110|OG002|Outcome|Oxymorphone ER 30 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 30 mg.
10979532|NCT00955110|OG003|Outcome|Oxycodone CR 30 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 30 mg.
10979533|NCT00955110|OG004|Outcome|Oxycodone CR 60 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 60 mg.
10979534|NCT00955110|EG000|Reported Event|Treatment Phase Placebo|Identical placebo capsules using size AA Swedish orange capsules and microcrystalline cellulose.
10979535|NCT00955110|EG001|Reported Event|Treatment Phase Oxymorphone ER 15 mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 15 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
10979536|NCT00955110|EG002|Reported Event|Treatment Phase Oxymorphone ER 30mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 30 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
10979537|NCT00955110|EG003|Reported Event|Treatment Phase Oxycodone CR 30mg|Single oral dose (1 capsule) of Oxycodone HCl CR 30 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
10979538|NCT00955110|EG004|Reported Event|Treatment Phase Oxycodone CR 60 mg|Single oral dose (1 capsule) of Oxycodone HCl CR 60 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
10979539|NCT00955201|BG000|Baseline|Sedentary|Sedentary Control Group
10979540|NCT00955201|BG001|Baseline|Aerobic Exercise|Structured aerobic exercise (treadmill).
10979541|NCT00955201|BG002|Baseline|Strength Exercise|Structured isokinetic strength exercise (dynameter).
10979542|NCT00955201|BG003|Baseline|Combined Aerobic and Strength|Structured aerobic exercise (treadmill).plus structured isokinetic strength exercise (dynameter).
10979543|NCT00955201|BG004|Baseline|Total|Total of all reporting groups
10979544|NCT00955201|FG000|Participant Flow|Sedentary|Sedentary Control Group
10979545|NCT00955201|FG001|Participant Flow|Aerobic Exercise|Structured aerobic exercise (treadmill).
10979546|NCT00955201|FG002|Participant Flow|Strength Exercise|Structured isokinetic strength exercise (dynameter).
10979547|NCT00955201|FG003|Participant Flow|Combined Aerobic and Strength|Structured aerobic exercise (treadmill) plus structured isokinetic strength exercise (dynameter).
10979548|NCT00955201|OG000|Outcome|Sedentary Control Group|Sedentary Control Group
10979549|NCT00955201|OG001|Outcome|Aerobic Exercise Group|"Aerobic Exercise Group~Exercise: Structured aerobic exercise (treadmill)."
10979550|NCT00955201|OG002|Outcome|Strength Exercise Group|"Strength Exercise Group~Exercise: Structured isokinetic strength exercise (dynameter)."
10979551|NCT00955201|OG003|Outcome|Combined Aerobic and Strength Exercise Group|"Combined Aerobic and Isokinetic Strength Exercise Group~Exercise: Structured aerobic exercise (treadmill).~Exercise: Structured isokinetic strength exercise (dynameter)."
10979552|NCT00955201|OG002|Outcome|Strength Exercise Group|"Isokinetic Strength Exercise Group~Exercise: Structured isokinetic strength exercise (dynameter)."
10979553|NCT00955201|OG001|Outcome|Aerobic Exercise Group|Structured aerobic exercise (treadmill).
10979554|NCT00955201|OG002|Outcome|Strength Exercise Group|Structured isokinetic strength exercise (dynameter).
10979555|NCT00955201|OG003|Outcome|Combined Aerobic and Strength Exercise Group|Structured aerobic exercise (treadmill) plus structured isokinetic strength exercise (dynameter).
10979556|NCT00955201|OG000|Outcome|Sedentary|Sedentary Control Group
10979557|NCT00955201|OG001|Outcome|Aerobic Exercise|Structured aerobic exercise (treadmill).
10979558|NCT00955201|OG002|Outcome|Strength Exercise|Structured isokinetic strength exercise (dynameter).
10979559|NCT00955201|OG003|Outcome|Combined Aerobic and Strength|Structured aerobic exercise (treadmill) plus structured isokinetic strength exercise (dynameter).
10979560|NCT00955201|OG003|Outcome|Combined Aerobic and Strength Exercise Group|Structured aerobic exercise (treadmill).plus structured isokinetic strength exercise (dynameter).
10979561|NCT00955201|EG000|Reported Event|Sedentary|Sedentary Control Group
10979562|NCT00955201|EG001|Reported Event|Aerobic Exercise|Structured aerobic exercise (treadmill)
10979563|NCT00955201|EG002|Reported Event|Strength Exercise|Structured isokinetic strength exercise (dynameter).
10979564|NCT00955201|EG003|Reported Event|Combined Aerobic and Strength|Structured aerobic exercise (treadmill) and structured isokinetic strength exercise (dynameter).
10979565|NCT00955253|BG000|Baseline|Drug and Placebo|"All patients will receive a single dose of drug and a single dose of placebo on separate days of the trial period. The order in which they receive these will be randomized.~Guanfacine: 2mg oral guanfacine (encapsulated)~Placebo: placebo"
10979566|NCT00955253|FG000|Participant Flow|Guanfacine Then Placebo|This group individuals are randomised to receive Guanfacine at the first treatment session and Placebo at the second treatment session.
10979567|NCT00955253|FG001|Participant Flow|Placebo Then Guanfacine|This group individuals are randomised to receive Placebo at the first treatment session and Guanfacine at the second treatment session.
10979568|NCT00955253|OG000|Outcome|All Patients|All individuals received guanfacine and placebo in a crossover design.
10979569|NCT00955253|OG000|Outcome|All Patients|All patients received guanfacine then placebo or vice versa.
10979570|NCT00955253|EG000|Reported Event|All Patients|All individuals received guanfacine and placebo in a crossover design.
10979571|NCT00955266|BG000|Baseline|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
10979572|NCT00955266|BG001|Baseline|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
10979573|NCT00955266|BG002|Baseline|Total|Total of all reporting groups
10979574|NCT00955266|FG000|Participant Flow|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
10979575|NCT00955266|FG001|Participant Flow|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
10979576|NCT00955266|OG000|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
10979577|NCT00955266|OG001|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
10979578|NCT00955266|EG000|Reported Event|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
10979579|NCT00955266|EG001|Reported Event|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
10979580|NCT00955279|BG000|Baseline|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
10979581|NCT00955279|BG001|Baseline|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
10979582|NCT00955279|BG002|Baseline|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
10979583|NCT00955279|BG003|Baseline|Total|Total of all reporting groups
10979584|NCT00955279|FG000|Participant Flow|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
10979585|NCT00955279|FG001|Participant Flow|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
10979586|NCT00955279|FG002|Participant Flow|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
10979587|NCT00955279|OG000|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
10979588|NCT00955279|OG001|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
10979589|NCT00955279|OG002|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
10979590|NCT00955279|EG000|Reported Event|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
10979591|NCT00955279|EG001|Reported Event|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
10979592|NCT00955279|EG002|Reported Event|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
10979593|NCT00955305|BG000|Baseline|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
10979594|NCT00955305|BG001|Baseline|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
10979595|NCT00955305|BG002|Baseline|Total|Total of all reporting groups
10979596|NCT00955305|FG000|Participant Flow|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
10979597|NCT00955305|FG001|Participant Flow|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
10979598|NCT00955305|OG000|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
10979599|NCT00955305|OG001|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
10979600|NCT00955305|EG000|Reported Event|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
10979601|NCT00955305|EG001|Reported Event|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
10979602|NCT00955357|BG000|Baseline|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
10979603|NCT00955357|BG001|Baseline|Later-Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
10979604|NCT00955357|BG002|Baseline|Total|Total of all reporting groups
10979605|NCT00955357|FG000|Participant Flow|First Add-on|"Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
10979606|NCT00955357|FG001|Participant Flow|Later Add-on|"Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
10979607|NCT00955357|OG000|Outcome|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
10979608|NCT00955357|OG001|Outcome|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
10979609|NCT00955357|EG000|Reported Event|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks):~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks):~200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks):~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
10979610|NCT00955357|EG001|Reported Event|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks):~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks):~200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks):~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
10979611|NCT00955409|BG000|Baseline|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979612|NCT00955409|BG001|Baseline|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10873428|NCT00427895|EG007|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
10873429|NCT00427895|EG008|Reported Event|13vPnC/23vPS, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
10873430|NCT00427895|EG009|Reported Event|13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
10873431|NCT00427895|EG010|Reported Event|23vPS/23vPS, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
10873432|NCT00427895|EG011|Reported Event|23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
10873433|NCT00427895|EG012|Reported Event|13vPnC/13vPnC, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
10873434|NCT00427895|EG013|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
10873435|NCT00427895|EG014|Reported Event|13vPnC, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
10873436|NCT00427895|EG015|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
10873437|NCT00427908|BG000|Baseline|Nimenrix 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.
10873438|NCT00427908|BG001|Baseline|Nimenrix 2-11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873439|NCT00427908|BG002|Baseline|Meningitec 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873440|NCT00427908|BG003|Baseline|Mencevax 2-11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
10873441|NCT00427908|BG004|Baseline|Total|Total of all reporting groups
10873442|NCT00427908|FG000|Participant Flow|Nimenrix 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.
10873443|NCT00427908|FG001|Participant Flow|Nimenrix 2-11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873444|NCT00427908|FG002|Participant Flow|Meningitec 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873445|NCT00427908|FG003|Participant Flow|Mencevax 2-11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
10873446|NCT00427908|OG000|Outcome|Nimenrix 2-11 Years of Age Primary Phase Group|Pooled group of subjects above 2 years of age, participating in the Primary Phase.
10873447|NCT00427908|OG001|Outcome|Mencevax 2-11 Years of Age Primary Phase Group|Pooled group of subjects above 2 years of age, participating in the Primary phase.
10873448|NCT00427908|OG000|Outcome|Nimenrix 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.
10873449|NCT00427908|OG001|Outcome|Meningitec 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873450|NCT00427908|OG001|Outcome|Meningitec 1- 2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873451|NCT00427908|OG000|Outcome|Nimenrix 2- 11 Years of Age Primary Phase Group|Pooled group of subjects above 2 years of age, participating in the Primary Phase.
10873452|NCT00427908|OG001|Outcome|Mencevax 2- 11 Years of Age Primary Phase Group|Pooled group of subjects above 2 years of age, participating in the Primary phase.
10873453|NCT00427908|OG001|Outcome|Mencevax 2- 11 Years of Age Primary Phase Group|Pooled group of subjects above 2 years of age, participating in the Primary Phase.
10873454|NCT00427908|OG000|Outcome|Nimenrix 6-11 Years of Age Group|Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873455|NCT00427908|OG001|Outcome|Mencevax 6-11 Years of Age Group|Subjects from 6 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
10873456|NCT00427908|OG001|Outcome|Meningitec 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region
10873457|NCT00427908|OG000|Outcome|Nimenrix 2- 11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873458|NCT00427908|OG001|Outcome|Mencevax 2- 11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
10873459|NCT00427908|OG001|Outcome|Mencevax 2- 11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose of Mencevax™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873460|NCT00427908|OG000|Outcome|Nimenrix 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region
10873461|NCT00427908|OG000|Outcome|Nimenrix 2- 11 Years of Age Group|Pooled group of subjects above 2 years of age.
10873462|NCT00427908|OG001|Outcome|Mencevax 2- 11 Years of Age Group|Pooled group of subjects above 2 years of age.
10873463|NCT00427908|OG001|Outcome|Meningitec 1- 2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region
10873464|NCT00427908|OG001|Outcome|Nimenrix 2-6 Years of Age Group|Subjects from 2 to 6 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873465|NCT00427908|OG002|Outcome|Nimenrix 6- 11 Years of Age Group|Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873466|NCT00427908|OG003|Outcome|Meningitec 1- 2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873467|NCT00427908|OG004|Outcome|Mencevax 2- 6 Years of Age Group|Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
10873468|NCT00427908|OG005|Outcome|Mencevax 6- 11 Years of Age Group|Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
10873469|NCT00427908|OG002|Outcome|Nimenrix 2- 11 Years of Age Primary Phase Group|Pooled group of subjects above 2 years of age, participating in the Primary Phase.
10873470|NCT00427908|OG003|Outcome|Mencevax 2- 11 Years of Age Primary Phase Group|Pooled group of subjects above 2 years of age, participating in the Primary Phase.
10873471|NCT00427908|OG003|Outcome|Mencevax 2- 11 Years of Age Primary Phase Group|Pooled group of subjects above 2 years of age, participating in the Primary phase.
10873472|NCT00427908|OG001|Outcome|Nimenrix 2- 11 Years of Age Group|Pooled group of subjects above 2 years of age.
10873473|NCT00427908|OG002|Outcome|Meningitec 1- 2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873474|NCT00427908|OG003|Outcome|Mencevax 2- 11 Years of Age Group|Pooled group of subjects above 2 years of age.
10873475|NCT00427908|EG000|Reported Event|Nimenrix 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.
10979613|NCT00955409|BG002|Baseline|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10873476|NCT00427908|EG001|Reported Event|Nimenrix 2-11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873477|NCT00427908|EG002|Reported Event|Meningitec 1-2 Years of Age Group|Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
10873478|NCT00427908|EG003|Reported Event|Mencevax 2-11 Years of Age Group|Subjects from 2 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
10873479|NCT00427921|BG000|Baseline|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
10873480|NCT00427921|FG000|Participant Flow|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
10873481|NCT00427921|OG000|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
10873482|NCT00427921|EG000|Reported Event|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
10873483|NCT00427934|BG000|Baseline|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
10873484|NCT00427934|BG001|Baseline|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
10873485|NCT00427934|BG002|Baseline|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873486|NCT00427934|BG003|Baseline|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873487|NCT00427934|BG004|Baseline|Total|Total of all reporting groups
10873488|NCT00427934|FG000|Participant Flow|Maraviroc 150 mg BID (Pharmacokinetic [PK])|150 mg tablet was administered by mouth twice a day (BID) for 4 weeks with stable weekly doses of methotrexate (MTX).
10873489|NCT00427934|FG001|Participant Flow|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
10873490|NCT00427934|FG002|Participant Flow|Maraviroc 300 mg BID (Proof-of-Concept [POC])|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873491|NCT00427934|FG003|Participant Flow|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873492|NCT00427934|OG000|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10979614|NCT00955409|BG003|Baseline|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979615|NCT00955409|BG004|Baseline|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979616|NCT00955409|BG005|Baseline|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979617|NCT00955409|BG006|Baseline|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979618|NCT00955409|BG007|Baseline|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979619|NCT00955409|BG008|Baseline|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979620|NCT00955409|BG009|Baseline|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979621|NCT00955409|BG010|Baseline|Total|Total of all reporting groups
10979622|NCT00955409|FG000|Participant Flow|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979623|NCT00955409|FG001|Participant Flow|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979624|NCT00955409|FG002|Participant Flow|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979625|NCT00955409|FG003|Participant Flow|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979626|NCT00955409|FG004|Participant Flow|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979627|NCT00955409|FG005|Participant Flow|PBS / ACC 10 µg+QS-21|Participants received Phosphate buffered Saline (PBS) in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979628|NCT00955409|FG006|Participant Flow|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979629|NCT00955409|FG007|Participant Flow|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979630|NCT00955409|FG008|Participant Flow|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979631|NCT00955409|FG009|Participant Flow|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979632|NCT00955409|OG000|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979633|NCT00955409|OG001|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979634|NCT00955409|OG002|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979635|NCT00955409|OG003|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979636|NCT00955409|OG004|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979637|NCT00955409|OG005|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979638|NCT00955409|OG006|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
11098962|NCT01579084|BG004|Baseline|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10979639|NCT00955409|OG007|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979640|NCT00955409|OG008|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979641|NCT00955409|OG009|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979642|NCT00955409|OG002|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979643|NCT00955409|OG002|Outcome|Active / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979644|NCT00955409|OG003|Outcome|Control / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979645|NCT00955409|OG004|Outcome|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979646|NCT00955409|OG005|Outcome|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979647|NCT00955409|OG006|Outcome|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979648|NCT00955409|OG007|Outcome|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979649|NCT00955409|OG008|Outcome|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979650|NCT00955409|EG000|Reported Event|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979651|NCT00955409|EG001|Reported Event|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979652|NCT00955409|EG002|Reported Event|Active / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979653|NCT00955409|EG003|Reported Event|Control / ACC 10µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979654|NCT00955409|EG004|Reported Event|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979655|NCT00955409|EG005|Reported Event|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10979656|NCT00955474|BG000|Baseline|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
10979657|NCT00955474|BG001|Baseline|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
10979658|NCT00955474|BG002|Baseline|Total|Total of all reporting groups
11007050|NCT01089127|EG002|Reported Event|Indacaterol 75 ug|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
10979659|NCT00955474|FG000|Participant Flow|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
10979660|NCT00955474|FG001|Participant Flow|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
10979661|NCT00955474|OG000|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
10979662|NCT00955474|OG001|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
10979663|NCT00955474|OG000|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
10979664|NCT00955474|OG001|Outcome|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
10979665|NCT00955474|EG000|Reported Event|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
10979666|NCT00955474|EG001|Reported Event|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
10979667|NCT00955487|BG000|Baseline|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
10979668|NCT00955487|BG001|Baseline|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
10979669|NCT00955487|BG002|Baseline|Total|Total of all reporting groups
10979670|NCT00955487|FG000|Participant Flow|500-749g Inhaled Nitric Oxide (iNO)|"Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10873493|NCT00427934|OG001|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873494|NCT00427934|OG000|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
10873495|NCT00427934|OG001|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
10873496|NCT00427934|OG002|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873497|NCT00427934|OG003|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873498|NCT00427934|EG000|Reported Event|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
10873499|NCT00427934|EG001|Reported Event|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
10873500|NCT00427934|EG002|Reported Event|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873501|NCT00427934|EG003|Reported Event|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
10873502|NCT00427960|BG000|Baseline|Rosuvastatin|rosuvastatin 5 mg
10873503|NCT00427960|BG001|Baseline|Atorvastatin|atorvastatin 10 mg
10873504|NCT00427960|BG002|Baseline|Total|Total of all reporting groups
10873505|NCT00427960|FG000|Participant Flow|Rosuvastatin|rosuvastatin 5 mg
10873506|NCT00427960|FG001|Participant Flow|Atorvastatin|atorvastatin 10 mg
10873507|NCT00427960|OG000|Outcome|Rosuvastatin|rosuvastatin 5 mg
10873508|NCT00427960|OG001|Outcome|Atorvastatin|atorvastatin 10 mg
10873509|NCT00427960|EG000|Reported Event|Rosuvastatin|rosuvastatin 5 mg
10873510|NCT00427960|EG001|Reported Event|Atorvastatin|atorvastatin 10 mg
10873511|NCT00427973|BG000|Baseline|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
10873512|NCT00427973|FG000|Participant Flow|Singe Arm Open Label Study With AZD2171 at 30 mg Daily.|Patients will receive AZD2171 by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies.
10873513|NCT00427973|OG000|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
10873514|NCT00427973|EG000|Reported Event|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) at 30 mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
10873515|NCT00427999|BG000|Baseline|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
10873516|NCT00427999|FG000|Participant Flow|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
10873517|NCT00427999|OG000|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
10873518|NCT00427999|EG000|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Core)|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks (Core)
10873519|NCT00427999|EG001|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Ext)|Extension follow-up
10873520|NCT00428077|BG000|Baseline|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
10873521|NCT00428077|FG000|Participant Flow|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
10873522|NCT00428077|OG000|Outcome|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients with Philadelphia Chromosome (Ph+) or Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL),positive Chronic Myeloid Leukemia(CML), in cytogenetic remission, with minimal residual disease.
10979671|NCT00955487|FG001|Participant Flow|500-749g Placebo (Nitrogen)|"Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979672|NCT00955487|FG002|Participant Flow|750-999g Inhaled Nitric Oxide (iNO)|"Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979673|NCT00955487|FG003|Participant Flow|750-999g Placebo (Nitrogen)|"Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979674|NCT00955487|FG004|Participant Flow|1000-1250g Inhaled Nitric Oxide (iNO)|"Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979675|NCT00955487|FG005|Participant Flow|1000-1250g Placebo (Nitrogen)|"Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979676|NCT00955487|OG000|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
10979677|NCT00955487|OG001|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
10979678|NCT00955487|OG000|Outcome|500-749g Inhaled Nitric Oxide (iNO)|"Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979679|NCT00955487|OG001|Outcome|500-749g Placebo (Nitrogen)|"Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979680|NCT00955487|OG002|Outcome|750-999g Inhaled Nitric Oxide (iNO)|"Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979681|NCT00955487|OG003|Outcome|750-999g Placebo (Nitrogen)|"Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979682|NCT00955487|OG004|Outcome|1000-1250g Inhaled Nitric Oxide (iNO)|"Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979683|NCT00955487|OG005|Outcome|1000-1250g Placebo (Nitrogen)|"Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
10979684|NCT00955487|EG000|Reported Event|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
10979685|NCT00955487|EG001|Reported Event|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
10979686|NCT00955513|BG000|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
10979687|NCT00955513|BG001|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
10979688|NCT00955513|BG002|Baseline|Placebo. Applied 3 Times a Day.|placebo
10979689|NCT00955513|BG003|Baseline|Total|Total of all reporting groups
10979690|NCT00955513|FG000|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
10979691|NCT00955513|FG001|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
10979692|NCT00955513|FG002|Participant Flow|Placebo. Applied 3 Times a Day.|placebo
10979693|NCT00955513|OG000|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
10979694|NCT00955513|OG001|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
10979695|NCT00955513|OG002|Outcome|Placebo. Applied 3 Times a Day.|placebo
10979696|NCT00955513|EG000|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
10979697|NCT00955513|EG001|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
10979698|NCT00955513|EG002|Reported Event|Placebo. Applied 3 Times a Day.|placebo
10979699|NCT00955617|BG000|Baseline|All Patients|All Patients received both product Dotarem and Gadovist during 2 enhanced-MRA. Demographic analysis was performed on the global population.
10979700|NCT00955617|FG000|Participant Flow|Dotarem Then Gadovist|Cross over administration, patient received first Dotarem enhanced-MRA (MRA1) and then Gadovist enhanced-MRA (MRA2)
10979701|NCT00955617|FG001|Participant Flow|Gadovist Then Dotarem|Cross over administration: patient received first Gadovist enhanced-MRA (MRA1) and then Dotarem enhanced-MRA (MRA2)
10979702|NCT00955617|OG000|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
10979703|NCT00955617|OG001|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
10979704|NCT00955617|EG000|Reported Event|Dotarem MRA|Patients who received a Dotarem enhanced-MRA
10979705|NCT00955617|EG001|Reported Event|Gadovist MRA|Patients who received a Gadovist enhanced-MRA
10979706|NCT00955682|BG000|Baseline|Nimenrix Group (Y2 - Y 5)|Subjects from Year 2, 3, 4, Month 49 and Year 5 period, vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
10979707|NCT00955682|BG001|Baseline|Meningitec Group (Y 2- Y 5)|Subjects from Year 2, 3, 4, Month 49 and Year 5 period, who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
10979708|NCT00955682|BG002|Baseline|Total|Total of all reporting groups
10979709|NCT00955682|FG000|Participant Flow|Nimenrix Group|Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
10979710|NCT00955682|FG001|Participant Flow|Meningitec Group|Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
10979711|NCT00955682|OG000|Outcome|Nimenrix Group Y2|Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
10979712|NCT00955682|OG001|Outcome|Meningitec Group Y2|Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
10979713|NCT00955682|OG000|Outcome|Nimenrix Group Y3|Subjects from Year 3 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
10979714|NCT00955682|OG001|Outcome|Meningitec Group Y3|Subjects from Year 3 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
10979715|NCT00955682|OG000|Outcome|Nimenrix Group Y4|Subjects from Year 4 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
10979716|NCT00955682|OG001|Outcome|Meningitec Group Y4|Subjects from Year 4 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
10979717|NCT00955682|OG000|Outcome|Nimenrix Group Month 49|Subjects from Booster Group vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group).
10979718|NCT00955682|OG001|Outcome|Meningitec Booster Group (Month 49)|Subjects from Booster Group who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
10979719|NCT00955682|OG000|Outcome|Nimenrix Group Y5|Subjects from Year 5 Period vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study
10979720|NCT00955682|OG001|Outcome|Meningitec Group Y5|Subjects from Year 5 Period who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
10979721|NCT00955682|EG000|Reported Event|Nimenrix Group|Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
10979722|NCT00955682|EG001|Reported Event|Meningitec Group|Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
10979723|NCT00955708|BG000|Baseline|Implants|"Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead~ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead"
10979724|NCT00955708|FG000|Participant Flow|Implants|"Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead~ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead"
10979725|NCT00955708|OG000|Outcome|Implants|"Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead~ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead"
10979726|NCT00955708|EG000|Reported Event|Implants|"Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead~ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead"
10979727|NCT00955721|BG000|Baseline|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979728|NCT00955721|BG001|Baseline|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979729|NCT00955721|BG002|Baseline|Total|Total of all reporting groups
10979730|NCT00955721|FG000|Participant Flow|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979731|NCT00955721|FG001|Participant Flow|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979732|NCT00955721|OG000|Outcome|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib.~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.~Gemcitabine: Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979733|NCT00955721|OG000|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979734|NCT00955721|OG000|Outcome|Phase 2 - RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.~Gemcitabine: Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979735|NCT00955721|EG000|Reported Event|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979736|NCT00955721|EG001|Reported Event|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
10979737|NCT00955747|BG000|Baseline|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
10979738|NCT00955747|BG001|Baseline|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
10979739|NCT00955747|BG002|Baseline|Total|Total of all reporting groups
10979740|NCT00955747|FG000|Participant Flow|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
10979741|NCT00955747|FG001|Participant Flow|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
10979742|NCT00955747|OG000|Outcome|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
10979743|NCT00955747|OG001|Outcome|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
10979744|NCT00955747|EG000|Reported Event|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
10979745|NCT00955747|EG001|Reported Event|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
10979746|NCT00955825|BG000|Baseline|300 IR|300 IR grass pollen allergen extract tablet
10979747|NCT00955825|BG001|Baseline|Placebo|Placebo tablet
10979748|NCT00955825|BG002|Baseline|Total|Total of all reporting groups
10979749|NCT00955825|FG000|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
10979750|NCT00955825|FG001|Participant Flow|Placebo|Placebo tablet
10979751|NCT00955825|OG000|Outcome|300 IR|300 IR grass pollen allergen extract tablet
10979752|NCT00955825|OG001|Outcome|Placebo|Placebo tablet
10979753|NCT00955825|EG000|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
10979754|NCT00955825|EG001|Reported Event|Placebo|Placebo tablet
10979755|NCT00955877|BG000|Baseline|DepoDur80|"DepoDur will be administered at 80μg/kg (not to exceed 5 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.~Extended-release Epidural morphine (EREM) 80: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (80μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979756|NCT00955877|BG001|Baseline|DepoDur120|"DepoDur will be administered at 120μg/kg (not to exceed 10 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.~Extended-release Epidural Morphine (EREM) 120: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (120μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979757|NCT00955877|BG002|Baseline|Control|"Preservative-free normal saline (2.5ml) will be placed in the L1 laminectomy defect and also dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter prior to wound closure.~Control: Saline: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Preservative-free normal saline (2.5 ml) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979758|NCT00955877|BG003|Baseline|Total|Total of all reporting groups
10979759|NCT00955877|FG000|Participant Flow|DepoDur80|"DepoDur will be administered at 80μg/kg (not to exceed 5 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.~Extended-release Epidural morphine (EREM) 80: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (80μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979760|NCT00955877|FG001|Participant Flow|DepoDur120|"DepoDur will be administered at 120μg/kg (not to exceed 10 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.~Extended-release Epidural Morphine (EREM) 120: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (120μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979761|NCT00955877|FG002|Participant Flow|Control|"Preservative-free normal saline (2.5ml) will be placed in the L1 laminectomy defect and also dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter prior to wound closure.~Control: Saline: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Preservative-free normal saline (2.5 ml) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979762|NCT00955877|OG000|Outcome|DepoDur80|"DepoDur will be administered at 80μg/kg (not to exceed 5 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.~Extended-release Epidural morphine (EREM) 80: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (80μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979763|NCT00955877|OG001|Outcome|DepoDur120|"DepoDur will be administered at 120μg/kg (not to exceed 10 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.~Extended-release Epidural Morphine (EREM) 120: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (120μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979764|NCT00955877|OG002|Outcome|Control|"Preservative-free normal saline (2.5ml) will be placed in the L1 laminectomy defect and also dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter prior to wound closure.~Control: Saline: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Preservative-free normal saline (2.5 ml) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979765|NCT00955877|EG000|Reported Event|DepoDur80|"DepoDur will be administered at 80μg/kg (not to exceed 5 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.~Extended-release Epidural morphine (EREM) 80: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (80μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
11098963|NCT01579084|BG005|Baseline|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10873523|NCT00428077|EG000|Reported Event|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
10873524|NCT00428090|BG000|Baseline|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873525|NCT00428090|BG001|Baseline|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873526|NCT00428090|BG002|Baseline|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873527|NCT00428090|BG003|Baseline|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873528|NCT00428090|BG004|Baseline|Total|Total of all reporting groups
10873529|NCT00428090|FG000|Participant Flow|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873530|NCT00428090|FG001|Participant Flow|RSG XR 2 mg|Par. in this arm received rosiglitazone extended release (RSGXR) 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873531|NCT00428090|FG002|Participant Flow|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873532|NCT00428090|FG003|Participant Flow|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873533|NCT00428090|OG000|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873534|NCT00428090|OG001|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873535|NCT00428090|OG002|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873536|NCT00428090|OG003|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873537|NCT00428090|OG000|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873538|NCT00428090|OG001|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873539|NCT00428090|OG002|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873540|NCT00428090|OG003|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873541|NCT00428090|OG002|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873542|NCT00428090|OG003|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
11098964|NCT01579084|BG006|Baseline|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
11098965|NCT01579084|BG007|Baseline|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
10873543|NCT00428090|OG003|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4Wof treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873544|NCT00428090|OG003|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873545|NCT00428090|EG000|Reported Event|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873546|NCT00428090|EG001|Reported Event|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
10873547|NCT00428090|EG002|Reported Event|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873548|NCT00428090|EG003|Reported Event|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
10873549|NCT00428116|BG000|Baseline|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
10873550|NCT00428116|BG001|Baseline|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
10873551|NCT00428116|BG002|Baseline|Total|Total of all reporting groups
10873552|NCT00428116|FG000|Participant Flow|Continued HAART|After 24 months of HAART, infants were continued on HAART.
10873553|NCT00428116|FG001|Participant Flow|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
10873554|NCT00428116|OG000|Outcome|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
10873555|NCT00428116|OG001|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
10873556|NCT00428116|OG000|Outcome|Continue HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
10873557|NCT00428116|EG000|Reported Event|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
10873558|NCT00428116|EG001|Reported Event|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
10873559|NCT00428220|BG000|Baseline|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
10873560|NCT00428220|FG000|Participant Flow|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
10873561|NCT00428220|OG000|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
10873562|NCT00428220|OG000|Outcome|Sunitinib 1|Parent Study: A6181078
10873563|NCT00428220|OG001|Outcome|Sunitinib 2|Parent Study: A6181087
10873564|NCT00428220|OG002|Outcome|Sunitinib 3|Parent Study: A6181094
10873565|NCT00428220|OG003|Outcome|Sunitinib 4|Parent Study: A6181107
10873566|NCT00428220|OG004|Outcome|Sunitinib 5|Parent Study: A6181110
10873567|NCT00428220|OG005|Outcome|Sunitinib 6|Parent Study: A6181111
10873568|NCT00428220|OG006|Outcome|Sunitinib 7|Parent Study: A6181112
10873569|NCT00428220|OG007|Outcome|Sunitinib 8|Parent Study: A6181113
10873570|NCT00428220|OG008|Outcome|Sunitinib 9|Parent Study: A6181120
10873571|NCT00428220|OG009|Outcome|Sunitinib 10|Parent Study: A6181126
10873572|NCT00428220|OG010|Outcome|Sunitinib 11|Parent Study: A6181170
10873573|NCT00428220|EG000|Reported Event|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
10873574|NCT00428246|BG000|Baseline|1|1 mcg paricalcitol
10873575|NCT00428246|BG001|Baseline|2|2 mcg paricalcitol
10873576|NCT00428246|BG002|Baseline|3|Placebo
10873577|NCT00428246|BG003|Baseline|Total|Total of all reporting groups
10873578|NCT00428246|FG000|Participant Flow|1|1 mcg paricalcitol
10873579|NCT00428246|FG001|Participant Flow|2|2 mcg paricalcitol
10873580|NCT00428246|FG002|Participant Flow|3|Placebo
10873581|NCT00428246|OG000|Outcome|1|1 mcg paricalcitol
10873582|NCT00428246|OG001|Outcome|2|2 mcg paricalcitol
10873583|NCT00428246|OG002|Outcome|3|Placebo
10873584|NCT00428246|EG000|Reported Event|1|1 mcg paricalcitol
10873585|NCT00428246|EG001|Reported Event|2|2 mcg paricalcitol
10873586|NCT00428246|EG002|Reported Event|3|Placebo
10873587|NCT00428298|BG000|Baseline|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
10873588|NCT00428298|BG001|Baseline|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
10873589|NCT00428298|BG002|Baseline|Total|Total of all reporting groups
10873590|NCT00428298|FG000|Participant Flow|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
10873591|NCT00428298|FG001|Participant Flow|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
10873592|NCT00428298|OG000|Outcome|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
10873593|NCT00428298|OG001|Outcome|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
10873594|NCT00428298|OG000|Outcome|Active Treatment Group - Valcyclovir|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
10873595|NCT00428298|OG001|Outcome|Inactive Treatment Group - Placebo|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
10873596|NCT00428298|EG000|Reported Event|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
10873597|NCT00428298|EG001|Reported Event|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
10873598|NCT00428389|BG000|Baseline|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
10873599|NCT00428389|BG001|Baseline|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
10873600|NCT00428389|BG002|Baseline|Total|Total of all reporting groups
10873601|NCT00428389|FG000|Participant Flow|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
10873602|NCT00428389|FG001|Participant Flow|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
10873603|NCT00428389|OG000|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
10873604|NCT00428389|OG001|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
10979766|NCT00955877|EG001|Reported Event|DepoDur120|"DepoDur will be administered at 120μg/kg (not to exceed 10 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.~Extended-release Epidural Morphine (EREM) 120: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (120μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979767|NCT00955877|EG002|Reported Event|Control|"Preservative-free normal saline (2.5ml) will be placed in the L1 laminectomy defect and also dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter prior to wound closure.~Control: Saline: After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Preservative-free normal saline (2.5 ml) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter."
10979768|NCT00955903|BG000|Baseline|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
10979769|NCT00955903|BG001|Baseline|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
10979770|NCT00955903|BG002|Baseline|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
10979771|NCT00955903|BG003|Baseline|Total|Total of all reporting groups
10979772|NCT00955903|FG000|Participant Flow|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
10979773|NCT00955903|FG001|Participant Flow|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
10979774|NCT00955903|FG002|Participant Flow|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
10979775|NCT00955903|OG000|Outcome|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
10979776|NCT00955903|OG001|Outcome|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
10979777|NCT00955903|OG002|Outcome|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
10979778|NCT00955903|EG000|Reported Event|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
10979779|NCT00955903|EG001|Reported Event|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
10979780|NCT00955903|EG002|Reported Event|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
10979781|NCT00955916|BG000|Baseline|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
10979782|NCT00955916|FG000|Participant Flow|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
10979783|NCT00955916|OG000|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
11098966|NCT01579084|BG008|Baseline|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
10979784|NCT00955916|EG000|Reported Event|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
10979785|NCT00955955|BG000|Baseline|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
10979786|NCT00955955|BG001|Baseline|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
10979787|NCT00955955|BG002|Baseline|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
10979788|NCT00955955|BG003|Baseline|Total|Total of all reporting groups
10979789|NCT00955955|FG000|Participant Flow|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
10979790|NCT00955955|FG001|Participant Flow|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
10979791|NCT00955955|FG002|Participant Flow|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
10979792|NCT00955955|OG000|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 1|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 4 weeks.
10979793|NCT00955955|OG001|Outcome|Adjunct Placebo Phase 1|Participants will receive placebo for the first 4 weeks
10979794|NCT00955955|OG002|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 2|Participants will receive 15 mg of Deplin (6(S)-5-MTHF) for 4 weeks.
10979795|NCT00955955|OG003|Outcome|Adjunct Placebo Phase 2|Patients in this group received placebo in both phases of the study for a total of 8 weeks,
10979796|NCT00955955|OG004|Outcome|Pooled Deplin|Patients in this group received Deplin at some point during the study. Results are pooled from phase I and II.
10979797|NCT00955955|OG005|Outcome|Pooled Placebo|Patients in this group received placebo at some point during the study. Results are pooled from phase I and II.
10979798|NCT00955955|OG000|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase I|Patients who received Deplin (L-methylfolate) for 4 weeks
10979799|NCT00955955|OG001|Outcome|Adjunct Placebo Phase I|Patients who received placebo for 4 weeks.
10979800|NCT00955955|OG002|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase II|Patients received Deplin for 4 weeks.
10979801|NCT00955955|OG003|Outcome|Adjunct Placebo Phase II|Patients received placebo for the second 4 weeks of the study. Patients who received placebo in phase 2 also received it in phase 1.
10979802|NCT00955955|EG000|Reported Event|Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF).
10979803|NCT00955955|EG001|Reported Event|Placebo|Adverse events for participants who received placebo during the study.
10979804|NCT00955968|BG000|Baseline|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
10979805|NCT00955968|BG001|Baseline|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
10979806|NCT00955968|BG002|Baseline|Total|Total of all reporting groups
10979807|NCT00955968|FG000|Participant Flow|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
10979808|NCT00955968|FG001|Participant Flow|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
10979809|NCT00955968|OG000|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
10979810|NCT00955968|OG001|Outcome|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
10979811|NCT00955968|OG000|Outcome|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
10979812|NCT00955968|OG001|Outcome|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
10979813|NCT00955968|OG000|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome
10979814|NCT00955968|EG000|Reported Event|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
10979815|NCT00955968|EG001|Reported Event|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
10979816|NCT00956020|BG000|Baseline|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979817|NCT00956020|FG000|Participant Flow|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979818|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979819|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.~Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
10979820|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979821|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.~Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
10979822|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979823|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979824|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 30 minutes after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979825|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979826|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 week after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979827|NCT00956020|OG000|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979828|NCT00956020|EG000|Reported Event|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
10979829|NCT00956085|BG000|Baseline|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).
10979830|NCT00956085|FG000|Participant Flow|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).
10979831|NCT00956085|OG000|Outcome|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response, either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).
10979832|NCT00956085|EG000|Reported Event|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).
10979833|NCT00956254|BG000|Baseline|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
10979834|NCT00956254|FG000|Participant Flow|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
10979835|NCT00956254|OG000|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
10979836|NCT00956254|OG001|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
10979837|NCT00956254|EG000|Reported Event|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
10979838|NCT00956254|EG001|Reported Event|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
10979839|NCT00956293|BG000|Baseline|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
10979840|NCT00956293|BG001|Baseline|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
10979841|NCT00956293|BG002|Baseline|Total|Total of all reporting groups
10979842|NCT00956293|FG000|Participant Flow|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
10979843|NCT00956293|FG001|Participant Flow|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
10979844|NCT00956293|FG002|Participant Flow|Pre-randomized Group|Participants, who met BL1 eligibility, were enrolled into the study.
10979845|NCT00956293|OG000|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
10979846|NCT00956293|OG001|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
11098967|NCT01579084|BG009|Baseline|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
11098968|NCT01579084|BG010|Baseline|Total|Total of all reporting groups
10979847|NCT00956293|EG000|Reported Event|Control Goup|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
10979848|NCT00956293|EG001|Reported Event|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
10979849|NCT00956540|BG000|Baseline|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
10979850|NCT00956540|BG001|Baseline|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
10979851|NCT00956540|BG002|Baseline|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
10979852|NCT00956540|BG003|Baseline|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
10979853|NCT00956540|BG004|Baseline|Total|Total of all reporting groups
10979854|NCT00956540|FG000|Participant Flow|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
10979855|NCT00956540|FG001|Participant Flow|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
10979856|NCT00956540|FG002|Participant Flow|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
10979857|NCT00956540|FG003|Participant Flow|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
10979858|NCT00956540|OG000|Outcome|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
10979859|NCT00956540|OG001|Outcome|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
10979860|NCT00956540|OG002|Outcome|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
10979861|NCT00956540|OG003|Outcome|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
10979862|NCT00956540|EG000|Reported Event|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
10979863|NCT00956540|EG001|Reported Event|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
10979864|NCT00956540|EG002|Reported Event|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
10979865|NCT00956540|EG003|Reported Event|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
10979866|NCT00956592|BG000|Baseline|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
10979867|NCT00956592|BG001|Baseline|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
10979868|NCT00956592|BG002|Baseline|Total|Total of all reporting groups
10979869|NCT00956592|FG000|Participant Flow|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
10979870|NCT00956592|FG001|Participant Flow|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
10979871|NCT00956592|OG000|Outcome|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
10979872|NCT00956592|OG001|Outcome|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
10979873|NCT00956592|OG000|Outcome|CMAC Video Laryngoscope|"Subjects will have their intubation attempted first with the CMAC video laryngoscope~CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement"
10979874|NCT00956592|OG001|Outcome|Macintosh Blade|"Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade~Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade"
10979875|NCT00956592|EG000|Reported Event|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
10979876|NCT00956592|EG001|Reported Event|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
10979877|NCT00956631|BG000|Baseline|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
10979878|NCT00956631|FG000|Participant Flow|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
10979879|NCT00956631|OG000|Outcome|Mild Procedure|Percutaneous decompression with the mild device kit.
10979880|NCT00956631|OG000|Outcome|Mild Procedure|Percutaneous lumbar decompression with the mild device kit.
10979881|NCT00956631|OG000|Outcome|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated using the mild® device kit in a percutaneous lumbar decompression procedure.
10979882|NCT00956631|EG000|Reported Event|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
10979883|NCT00956657|BG000|Baseline|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
10979884|NCT00956657|BG001|Baseline|Treatment As Usual|Control group. Treatment received as usual.
10979885|NCT00956657|BG002|Baseline|Total|Total of all reporting groups
10979886|NCT00956657|FG000|Participant Flow|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
10979887|NCT00956657|FG001|Participant Flow|Treatment As Usual|Control group. Treatment received as usual.
10979888|NCT00956657|OG000|Outcome|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
10979889|NCT00956657|OG001|Outcome|Treatment As Usual|Control group. Treatment received as usual.
10979890|NCT00956657|EG000|Reported Event|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
10979891|NCT00956657|EG001|Reported Event|Treatment As Usual|Control group. Treatment received as usual.
10979892|NCT00956709|BG000|Baseline|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
10979893|NCT00956709|BG001|Baseline|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
10979894|NCT00956709|BG002|Baseline|Total|Total of all reporting groups
10979895|NCT00956709|FG000|Participant Flow|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
10979896|NCT00956709|FG001|Participant Flow|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
10979897|NCT00956709|OG000|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
10979898|NCT00956709|OG001|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
10979899|NCT00956709|EG000|Reported Event|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
10979900|NCT00956709|EG001|Reported Event|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
10979901|NCT00956761|BG000|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
10979902|NCT00956761|FG000|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
10979903|NCT00956761|OG000|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
10979904|NCT00956761|OG000|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
10979905|NCT00956761|EG000|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
10979906|NCT00956813|BG000|Baseline|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
10979907|NCT00956813|BG001|Baseline|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
10979908|NCT00956813|BG002|Baseline|Total|Total of all reporting groups
10979909|NCT00956813|FG000|Participant Flow|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
10979910|NCT00956813|FG001|Participant Flow|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
10979911|NCT00956813|OG000|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
10979912|NCT00956813|OG001|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
10979913|NCT00956813|EG000|Reported Event|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
10979914|NCT00956813|EG001|Reported Event|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
10979915|NCT00956813|EG002|Reported Event|Optional Continuation Period|After completing the Placebo/Flaxseed double-blind period, patients were allowed to continue with 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
10979916|NCT00956839|BG000|Baseline|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
10979917|NCT00956839|BG001|Baseline|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
10979918|NCT00956839|BG002|Baseline|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
10979919|NCT00956839|BG003|Baseline|Total|Total of all reporting groups
10979920|NCT00956839|FG000|Participant Flow|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
10979921|NCT00956839|FG001|Participant Flow|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
10979922|NCT00956839|FG002|Participant Flow|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
10979923|NCT00956839|OG000|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
10979924|NCT00956839|OG001|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
10979925|NCT00956839|OG002|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
10979926|NCT00956839|EG000|Reported Event|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
10979927|NCT00956839|EG001|Reported Event|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
10979928|NCT00956839|EG002|Reported Event|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
10979929|NCT00956930|BG000|Baseline|Arm I (Radioembolization)|"Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.~yttrium Y 90 glass microspheres: Patients undergo radioembolization."
10979930|NCT00956930|BG001|Baseline|Arm II (Transarterial Chemoembolization [TACE])|"Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.~Doxorubicin: 75mg fixed dose"
10979931|NCT00956930|BG002|Baseline|Total|Total of all reporting groups
10979932|NCT00956930|FG000|Participant Flow|Arm I (Radioembolization)|"Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.~yttrium Y 90 glass microspheres: Patients undergo radioembolization."
10979933|NCT00956930|FG001|Participant Flow|Arm II (Transarterial Chemoembolization [TACE])|"Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.~Doxorubicin: 75mg fixed dose"
10979934|NCT00956930|OG000|Outcome|Arm I (Radioembolization)|"Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.~yttrium Y 90 glass microspheres: Patients undergo radioembolization."
10979935|NCT00956930|OG001|Outcome|Arm II (Transarterial Chemoembolization [TACE])|"Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.~Doxorubicin: 75mg fixed dose"
10979936|NCT00956930|OG000|Outcome|Arm I (Radioembolization)|Patients undergo radioembolization with yttrium-90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
10979937|NCT00956930|OG001|Outcome|Arm II (Transarterial Chemoembolization [TACE])|"Patients undergo chemoembolization (TACE) with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.~Doxorubicin: 75mg fixed dose"
10979938|NCT00956930|EG000|Reported Event|Arm I (Radioembolization)|Patients undergo radioembolization with yttrium-90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
10979939|NCT00956930|EG001|Reported Event|Arm II (Transarterial Chemoembolization [TACE])|"Patients undergo chemoembolization (TACE) with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.~Doxorubicin: 75mg fixed dose"
10979940|NCT00956943|BG000|Baseline|21mg Transdermal Nicotine + Placebo Patch|
10979941|NCT00956943|BG001|Baseline|42mg Transdermal Nicotine|
10979942|NCT00956943|BG002|Baseline|Total|Total of all reporting groups
10979943|NCT00956943|FG000|Participant Flow|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
10979944|NCT00956943|FG001|Participant Flow|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
10979945|NCT00956943|OG000|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
10979946|NCT00956943|OG001|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
10979947|NCT00956943|EG000|Reported Event|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
10979948|NCT00956943|EG001|Reported Event|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
10979949|NCT00957008|BG000|Baseline|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
10979950|NCT00957008|BG001|Baseline|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
10979951|NCT00957008|BG002|Baseline|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
10979952|NCT00957008|BG003|Baseline|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual's focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
10979953|NCT00957008|BG004|Baseline|Total|Total of all reporting groups
10979954|NCT00957008|FG000|Participant Flow|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
10979955|NCT00957008|FG001|Participant Flow|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
10979956|NCT00957008|FG002|Participant Flow|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
10979957|NCT00957008|FG003|Participant Flow|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual's focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
10979958|NCT00957008|OG000|Outcome|A - GWL|"Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.~Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual."
10979959|NCT00957008|OG001|Outcome|B - GWL+SWA|"Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.~Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning"
10979960|NCT00957008|OG002|Outcome|C - SWA Alone|"Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.~Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband."
10979961|NCT00957008|OG003|Outcome|D - Standard Care|Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
10979962|NCT00957008|OG000|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
10979963|NCT00957008|OG001|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
10979964|NCT00957008|OG002|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
10979965|NCT00957008|OG003|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual's focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
10979966|NCT00957008|EG000|Reported Event|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
10979967|NCT00957008|EG001|Reported Event|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
10979968|NCT00957008|EG002|Reported Event|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
10979969|NCT00957008|EG003|Reported Event|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual's focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
11007051|NCT01089127|EG003|Reported Event|Indacaterol 150 ug|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007052|NCT01089127|EG004|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007053|NCT01089127|EG005|Reported Event|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
11007054|NCT01089231|BG000|Baseline|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
11007055|NCT01089231|BG001|Baseline|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
11007056|NCT01089231|BG002|Baseline|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
11007057|NCT01089231|BG003|Baseline|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
11007058|NCT01089231|BG004|Baseline|Total|Total of all reporting groups
11007059|NCT01089231|FG000|Participant Flow|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
11007060|NCT01089231|FG001|Participant Flow|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
11007061|NCT01089231|FG002|Participant Flow|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
11007062|NCT01089231|FG003|Participant Flow|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
11007063|NCT01089231|OG000|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
11007064|NCT01089231|OG001|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
11007065|NCT01089231|OG002|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
11007066|NCT01089231|OG003|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
10979970|NCT00957021|BG000|Baseline|Triathlon® PS Total Knee System|Participants who were not censored from analysis.
10979971|NCT00957021|FG000|Participant Flow|Triathlon® PS Total Knee System|If both knees were replaced, but only one knee completed the study, the participant is counted as completed.
10979972|NCT00957021|OG000|Outcome|Triathlon® PS Total Knee System|Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
10979973|NCT00957021|OG000|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
10979974|NCT00957021|EG000|Reported Event|Triathlon® PS Total Knee System|All non-censored participants who received the Triathlon® PS Total Knee System.
10979975|NCT00957047|BG000|Baseline|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
10979976|NCT00957047|BG001|Baseline|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
10979977|NCT00957047|BG002|Baseline|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
10979978|NCT00957047|BG003|Baseline|Placebo|placebo : once daily placebo comparator
10979979|NCT00957047|BG004|Baseline|Total|Total of all reporting groups
10979980|NCT00957047|FG000|Participant Flow|Placebo|placebo : once daily placebo comparator
10979981|NCT00957047|FG001|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
10979982|NCT00957047|FG002|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
10979983|NCT00957047|FG003|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
10979984|NCT00957047|FG004|Participant Flow|ESL - Part II|All patients in Part II received ESL on an open-label basis, starting at 800 mg once daily.
10979985|NCT00957047|OG000|Outcome|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
10979986|NCT00957047|OG001|Outcome|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
10979987|NCT00957047|OG002|Outcome|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
10979988|NCT00957047|OG003|Outcome|Placebo|placebo : once daily placebo comparator
10979989|NCT00957047|OG000|Outcome|TEAE|
10979990|NCT00957047|OG001|Outcome|TEAE With Onset Within the 1st 4 Weeks|
10979991|NCT00957047|OG002|Outcome|TEAE With Onset After 1st 4 Weeks|
10979992|NCT00957047|OG003|Outcome|Treatment-related TEAE|
10979993|NCT00957047|OG004|Outcome|TEAE Leading to Discontinuation|
10979994|NCT00957047|OG005|Outcome|Serious TEAE|
10979995|NCT00957047|OG006|Outcome|TEAE Leading to Death|
10979996|NCT00957047|EG000|Reported Event|Placebo|Tablets; oral route
10979997|NCT00957047|EG001|Reported Event|ESL 400 mg|Tablets; oral route
10979998|NCT00957047|EG002|Reported Event|ESL 800 mg|Tablets; oral route
10979999|NCT00957047|EG003|Reported Event|ESL 1200 mg|Tablets; oral route
10980000|NCT00957047|EG004|Reported Event|ESL PART II|All patients in Part II received ESL
10980001|NCT00957229|BG000|Baseline|Sugar Pill|"placebo pill by mouth once daily~GDC-0449: capsule, 150 mg, one pill daily, 18 months"
10980002|NCT00957229|BG001|Baseline|GDC-0449|"vismodegib 150MG by mouth once daily~GDC-0449: capsule, 150 mg, one pill daily, 18 months"
10980003|NCT00957229|BG002|Baseline|Total|Total of all reporting groups
10980004|NCT00957229|FG000|Participant Flow|Sugar Pill|"placebo pill by mouth once daily~GDC-0449: capsule, 150 mg, one pill daily, 18 months"
10980005|NCT00957229|FG001|Participant Flow|GDC-0449|"vismodegib 150MG by mouth once daily~GDC-0449: capsule, 150 mg, one pill daily, 18 months"
10980006|NCT00957229|OG000|Outcome|Sugar Pill|"placebo pill by mouth once daily~GDC-0449: capsule, 150 mg, one pill daily, 18 months"
10980007|NCT00957229|OG001|Outcome|GDC-0449|"vismodegib 150MG by mouth once daily~GDC-0449: capsule, 150 mg, one pill daily, 18 months"
10980008|NCT00957229|EG000|Reported Event|Sugar Pill|"placebo pill by mouth once daily~GDC-0449: capsule, 150 mg, one pill daily, 18 months"
10980009|NCT00957229|EG001|Reported Event|GDC-0449|"vismodegib 150MG by mouth once daily~GDC-0449: capsule, 150 mg, one pill daily, 18 months"
10980010|NCT00957242|BG000|Baseline|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
10980011|NCT00957242|BG001|Baseline|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
10980012|NCT00957242|BG002|Baseline|Total|Total of all reporting groups
10980013|NCT00957242|FG000|Participant Flow|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
10980014|NCT00957242|FG001|Participant Flow|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
10980015|NCT00957242|OG000|Outcome|Placebo|matched placebo
10980016|NCT00957242|OG001|Outcome|Warfarin|warfarin sodium titrated to an INR of 2.0-3.0
10980017|NCT00957242|OG000|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
10980018|NCT00957242|OG001|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
10980019|NCT00957242|EG000|Reported Event|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
10980020|NCT00957242|EG001|Reported Event|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
10980021|NCT00957268|BG000|Baseline|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
10980022|NCT00957268|BG001|Baseline|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980023|NCT00957268|BG002|Baseline|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
10980024|NCT00957268|BG003|Baseline|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980025|NCT00957268|BG004|Baseline|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980026|NCT00957268|BG005|Baseline|Total|Total of all reporting groups
10980027|NCT00957268|FG000|Participant Flow|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
10980028|NCT00957268|FG001|Participant Flow|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980029|NCT00957268|FG002|Participant Flow|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
10980030|NCT00957268|FG003|Participant Flow|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980031|NCT00957268|FG004|Participant Flow|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980032|NCT00957268|OG000|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
10980033|NCT00957268|OG001|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980034|NCT00957268|OG002|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
10980035|NCT00957268|OG003|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980036|NCT00957268|OG004|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980037|NCT00957268|EG000|Reported Event|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
10980038|NCT00957268|EG001|Reported Event|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980039|NCT00957268|EG002|Reported Event|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
10980040|NCT00957268|EG003|Reported Event|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980041|NCT00957268|EG004|Reported Event|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
10980042|NCT00957333|BG000|Baseline|Case|"ketamine + Cystitis~ketamine"
10980043|NCT00957333|FG000|Participant Flow|Case|"ketamine + Cystitis~ketamine"
10980044|NCT00957333|OG000|Outcome|Case|"ketamine + Cystitis~ketamine"
10980045|NCT00957333|EG000|Reported Event|Case|"ketamine + Cystitis~ketamine"
10980046|NCT00957359|BG000|Baseline|Psilocybin First, Then Niacin|Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg
10980047|NCT00957359|BG001|Baseline|Niacin First, Then Psilocybin|Niacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
10980048|NCT00957359|BG002|Baseline|Total|Total of all reporting groups
10980049|NCT00957359|FG000|Participant Flow|Psilocybin First, Then Niacin|Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg.
10980050|NCT00957359|FG001|Participant Flow|Niacin First, Then Psilocybin|Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
10980051|NCT00957359|OG000|Outcome|Psilocybin First, Then Niacin|"Drug intervention~Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg~Niacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg"
10980052|NCT00957359|OG001|Outcome|Niacin First, Then Psilocybin|"Active control~Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg~Niacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg"
10980053|NCT00957359|EG000|Reported Event|Psilocybin|Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
10980054|NCT00957359|EG001|Reported Event|Niacin|Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
10980055|NCT00957372|BG000|Baseline|ESL 1200mg Daily|"ESL 1200mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
10980056|NCT00957372|BG001|Baseline|ESL 800mg Daily|"ESL 800mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
10980057|NCT00957372|BG002|Baseline|Placebo|"placebo~placebo : once daily placebo comparator"
10980058|NCT00957372|BG003|Baseline|Total|Total of all reporting groups
10980059|NCT00957372|FG000|Participant Flow|ESL 1200mg Daily|"ESL 1200mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
10980060|NCT00957372|FG001|Participant Flow|ESL 800mg Daily|"ESL 800mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
10980061|NCT00957372|FG002|Participant Flow|Placebo|"placebo~placebo : once daily placebo comparator"
10980062|NCT00957372|FG003|Participant Flow|Open-label Extension (Part II)|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
10980063|NCT00957372|OG000|Outcome|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied.
10980064|NCT00957372|OG001|Outcome|ESL 800 mg|400 mg active substance tablets were supplied
10980065|NCT00957372|OG002|Outcome|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
10980066|NCT00957372|OG000|Outcome|TEAE|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
10980067|NCT00957372|OG001|Outcome|TEAE With Onset Within the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
10980068|NCT00957372|OG002|Outcome|TEAE With Onset After the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
10980069|NCT00957372|OG003|Outcome|Treatment-related Treatment-emergent Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
10980070|NCT00957372|OG004|Outcome|TEAE Leading to Discontinuation From the Study|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
10980071|NCT00957372|OG005|Outcome|Treatment Emergent Serious Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
10980072|NCT00957372|OG006|Outcome|TEAE Leading to Death|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
10980073|NCT00957372|EG000|Reported Event|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied
10980074|NCT00957372|EG001|Reported Event|ESL 800 mg|400 mg active substance tablets were supplied
10980075|NCT00957372|EG002|Reported Event|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
10980076|NCT00957372|EG003|Reported Event|Open-label Extension (Part II)|ESL dose taken; Starting at 800 mg once daily, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg once daily or up to a maximum of 1200 mg once daily.
10980077|NCT00957424|BG000|Baseline|Overall|Single-armed study
10980078|NCT00957424|FG000|Participant Flow|Noncombusted Nicotine Product With Informational Intervention|Single-armed study
10980079|NCT00957424|OG000|Outcome|Overall|Single-armed study
10980080|NCT00957424|EG000|Reported Event|Overall|Single-armed study
10980081|NCT00957528|BG000|Baseline|Placebo|Weekly placebo treatment for a duration of 5 months.
10980082|NCT00957528|BG001|Baseline|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
10980083|NCT00957528|BG002|Baseline|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
10980084|NCT00957528|BG003|Baseline|Total|Total of all reporting groups
10980085|NCT00957528|FG000|Participant Flow|Placebo|Weekly placebo treatment for a duration of 5 months.
10980086|NCT00957528|FG001|Participant Flow|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
10980087|NCT00957528|FG002|Participant Flow|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
10980088|NCT00957528|OG000|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
10980089|NCT00957528|OG001|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
10980090|NCT00957528|OG002|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
10980091|NCT00957528|EG000|Reported Event|Placebo|Weekly placebo treatment for a duration of 5 months.
10980092|NCT00957528|EG001|Reported Event|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
10980093|NCT00957528|EG002|Reported Event|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
11007067|NCT01089231|EG000|Reported Event|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
11007068|NCT01089231|EG001|Reported Event|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
11007069|NCT01089231|EG002|Reported Event|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
11007070|NCT01089231|EG003|Reported Event|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
11007071|NCT01089361|BG000|Baseline|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
11007072|NCT01089361|BG001|Baseline|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
11007073|NCT01089361|BG002|Baseline|Total|Total of all reporting groups
11007074|NCT01089361|FG000|Participant Flow|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
11007075|NCT01089361|FG001|Participant Flow|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
11007076|NCT01089361|OG000|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
11007077|NCT01089361|OG001|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
11007078|NCT01089361|OG000|Outcome|Normal Saline Placebo|"The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.~Normal Saline placebo: The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours."
11007079|NCT01089361|OG001|Outcome|Ketamine|"The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.~Ketamine: The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours."
11007080|NCT01089361|EG000|Reported Event|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
11007081|NCT01089361|EG001|Reported Event|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
10980094|NCT00957580|BG000|Baseline|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980095|NCT00957580|BG001|Baseline|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980096|NCT00957580|BG002|Baseline|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980097|NCT00957580|BG003|Baseline|Total|Total of all reporting groups
10980098|NCT00957580|FG000|Participant Flow|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980099|NCT00957580|FG001|Participant Flow|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980100|NCT00957580|FG002|Participant Flow|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980101|NCT00957580|OG000|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980102|NCT00957580|OG001|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980103|NCT00957580|OG002|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980104|NCT00957580|OG000|Outcome|Regimen 1 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980105|NCT00957580|OG001|Outcome|Regimen 2 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980106|NCT00957580|OG000|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980107|NCT00957580|OG001|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980108|NCT00957580|OG002|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980109|NCT00957580|OG003|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980110|NCT00957580|OG004|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980111|NCT00957580|OG005|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980112|NCT00957580|OG006|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980113|NCT00957580|OG007|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980114|NCT00957580|OG008|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980115|NCT00957580|OG007|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980116|NCT00957580|OG000|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980117|NCT00957580|EG000|Reported Event|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980118|NCT00957580|EG001|Reported Event|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980119|NCT00957580|EG002|Reported Event|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
10980120|NCT00957593|BG000|Baseline|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
10980121|NCT00957593|BG001|Baseline|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
10980122|NCT00957593|BG002|Baseline|Total|Total of all reporting groups
10980123|NCT00957593|FG000|Participant Flow|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
10980124|NCT00957593|FG001|Participant Flow|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
10980125|NCT00957593|OG000|Outcome|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
10980126|NCT00957593|OG001|Outcome|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
10980127|NCT00957593|OG000|Outcome|Routine|Routine use of oxytocin vs discontinuation of oxytocin once in active labor
10980128|NCT00957593|OG001|Outcome|Discontinuation|Oxytocin discontinued in the active phase of labor
10980129|NCT00957593|EG000|Reported Event|Oxytocin Arm|no adverse effects noted amongst the 252 patients enrolled in the study 127 in ROUTINE 125 in DISCONTINUATION ARM
10980130|NCT00957593|EG001|Reported Event|Oxytocin Discontinuation|Oxytocin discontinuation in the active phase of labor
10980131|NCT00957658|BG000|Baseline|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
10980132|NCT00957658|FG000|Participant Flow|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.
10980133|NCT00957658|OG000|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
10980134|NCT00957658|OG000|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
10980135|NCT00957658|OG000|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem.
10980136|NCT00957658|EG000|Reported Event|Accolade TMZF Hip Stem|Participants who received the Accolade TMZF Hip Stem
10980137|NCT00957671|BG000|Baseline|Human Growth Hormone|"Recombinant human growth hormone (rhGH) self administered daily for one year~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)"
10980138|NCT00957671|FG000|Participant Flow|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
10980139|NCT00957671|OG000|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
10980140|NCT00957671|OG000|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year~Recombinant human growth hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)"
10980141|NCT00957671|EG000|Reported Event|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
10980142|NCT00957684|BG000|Baseline|ESL 1200 mg|400-mg + 800-mg; once daily administration by oral route
10980143|NCT00957684|BG001|Baseline|ESL 800 mg|800-mg; once daily administration by oral route
10980144|NCT00957684|BG002|Baseline|ESL 400 mg|400-mg; once daily administration by oral route
10980145|NCT00957684|BG003|Baseline|Placebo|Placebo tablets; once daily administration by oral route
10980146|NCT00957684|BG004|Baseline|Total|Total of all reporting groups
10980147|NCT00957684|FG000|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
10980148|NCT00957684|FG001|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
10980149|NCT00957684|FG002|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
10980150|NCT00957684|FG003|Participant Flow|Placebo|placebo : once daily placebo comparator
10980151|NCT00957684|FG004|Participant Flow|ESL - Part II|During Part II of the study all patients received ESL, including those who had been treated with placebo during Part I. The duration of treatment during Part II was one year for all patients completing the study.
10980152|NCT00957684|OG000|Outcome|Placebo|Placebo tablets matching the 400-mg and 800-mg active substance tablets were supplied; once daily administration by oral route.
10980153|NCT00957684|OG001|Outcome|ESL 400 mg|ESL was supplied in 400-mg tablets; once daily administration by oral route.
10980154|NCT00957684|OG002|Outcome|ESL 800 mg|ESL was supplied in 800-mg tablets; once daily administration by oral route.
10980155|NCT00957684|OG003|Outcome|ESL 1200 mg|ESL was supplied in 400-mg and 800-mg tablets; once daily administration by oral route.
10980156|NCT00957684|EG000|Reported Event|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
10980157|NCT00957684|EG001|Reported Event|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
10980158|NCT00957684|EG002|Reported Event|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
10980159|NCT00957684|EG003|Reported Event|Placebo|placebo : once daily placebo comparator
10980160|NCT00957723|BG000|Baseline|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
10980161|NCT00957723|FG000|Participant Flow|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System can have one or both knees replaced. If both knees were replaced, but only one knee completed the study, the participant is counted as having completed.
10980162|NCT00957723|OG000|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
10980163|NCT00957723|OG000|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System, and consented to the long-term follow-up study.
10980164|NCT00957723|EG000|Reported Event|Operative-Site Adverse Events|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. Operative-site events are reported by knee.
10980165|NCT00957723|EG001|Reported Event|Systemic Adverse Events|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. Systemic events are reported by participant.
10980166|NCT00957801|BG000|Baseline|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
10980167|NCT00957801|BG001|Baseline|Testosterone Gel|"Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
10980168|NCT00957801|BG002|Baseline|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
10980169|NCT00957801|BG003|Baseline|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
10980170|NCT00957801|BG004|Baseline|Total|Total of all reporting groups
10980171|NCT00957801|FG000|Participant Flow|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
10980172|NCT00957801|FG001|Participant Flow|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
10980173|NCT00957801|FG002|Participant Flow|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
10980174|NCT00957801|FG003|Participant Flow|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
10980175|NCT00957801|OG000|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
10980176|NCT00957801|OG001|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
10980177|NCT00957801|OG002|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
10980178|NCT00957801|OG003|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
10980179|NCT00957801|EG000|Reported Event|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
10980180|NCT00957801|EG001|Reported Event|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
10980181|NCT00957801|EG002|Reported Event|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
10980182|NCT00957801|EG003|Reported Event|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
10980183|NCT00957853|BG000|Baseline|Cetuximab|Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses.
10980184|NCT00957853|BG001|Baseline|IMC-A12|Subjects received IMC-A12 at 6 mg/kg
10980185|NCT00957853|BG002|Baseline|Cetuximab + IMC-A12|Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg
10980186|NCT00957853|BG003|Baseline|Total|Total of all reporting groups
10980187|NCT00957853|FG000|Participant Flow|Cetuximab|Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses
10980188|NCT00957853|FG001|Participant Flow|IMC-A12|Subjects received IMC-A12 at 6 mg/kg
10980189|NCT00957853|FG002|Participant Flow|Cetuximab + IMC-A12|Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg
10980190|NCT00957853|OG000|Outcome|Cetuximab|Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses
10980191|NCT00957853|OG001|Outcome|IMC-A12|Subjects received IMC-A12 at 6 mg/kg
10980192|NCT00957853|OG002|Outcome|Cetuximab + IMC-A12|Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg
10980193|NCT00957853|EG000|Reported Event|Cetuximab|Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses
10980194|NCT00957853|EG001|Reported Event|IMC-A12|Subjects received IMC-A12 at 6 mg/kg
10980195|NCT00957853|EG002|Reported Event|Cetuximab + IMC-A12|Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg
10980196|NCT00957905|BG000|Baseline|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10980197|NCT00957905|BG001|Baseline|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10980198|NCT00957905|BG002|Baseline|Total|Total of all reporting groups
10980199|NCT00957905|FG000|Participant Flow|Part A|6 weeks: Flavopiridol: 70 mg/m2/day IV over 1 hr on days 1, 15 and 29. Oxaliplatin: 85 mg/m2/day IV over 2 hrs on days 1, 15 and 29.
10980200|NCT00957905|FG001|Participant Flow|Part B|"6 wks: Flavopiridol:70 mg/m2/day IV 1 hr Days 1, 15 & 29. Oxaliplatin:85 mg/m2/day IV 2 hrs Days 1, 15 & 29. Leucovorin:400 mg/m2/day IV 2 hrs Days 1, 15 & 29.~5-FU: 400 mg/m2 IV 15 min, and 1800 mg/m2 IV 48 hrs Days 1-2, 15-16 & 29-30."
10980201|NCT00957905|OG000|Outcome|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10980202|NCT00957905|OG001|Outcome|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10980203|NCT00957905|EG000|Reported Event|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10980204|NCT00957905|EG001|Reported Event|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10980205|NCT00957931|BG000|Baseline|Mesenchymal Stromal Cells|Patients received bone marrow transplantation using matched unrelated donors, reduced intensity conditioning regimen, and co-transplanting mesenchymal stromal cells derived from parental bone marrow.
10980206|NCT00957931|FG000|Participant Flow|Mesenchymal Stromal Cells|Patients received bone marrow transplantation using matched unrelated donors, reduced intensity conditioning regimen, and co-transplanting mesenchymal stromal cells derived from parental bone marrow.
10980207|NCT00957931|OG000|Outcome|Mesenchymal Stromal Cells|Patients received bone marrow transplantation using matched unrelated donors, reduced intensity conditioning regimen, and co-transplanting mesenchymal stromal cells derived from parental bone marrow.
10980208|NCT00957931|EG000|Reported Event|Mesenchymal Stromal Cells|Patients received bone marrow transplantation using matched unrelated donors, reduced intensity conditioning regimen, and co-transplanting mesenchymal stromal cells derived from parental bone marrow.
10980209|NCT00957944|BG000|Baseline|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
10980210|NCT00957944|BG001|Baseline|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
10980211|NCT00957944|BG002|Baseline|Total|Total of all reporting groups
10980212|NCT00957944|FG000|Participant Flow|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
10980213|NCT00957944|FG001|Participant Flow|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
10980214|NCT00957944|OG000|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
10980215|NCT00957944|OG001|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
10980216|NCT00957944|EG000|Reported Event|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
10980217|NCT00957944|EG001|Reported Event|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
10980218|NCT00957996|BG000|Baseline|Peramivir 300mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
10980219|NCT00957996|BG001|Baseline|Peramivir 600mg|"600 mg once daily~Peramivir: 600 mg once daily"
10980220|NCT00957996|BG002|Baseline|Total|Total of all reporting groups
10980221|NCT00957996|FG000|Participant Flow|Peramivir 300 mg|Peramivir 300 mg twice daily
10980222|NCT00957996|FG001|Participant Flow|Peramivir 600 mg|Peramivir 600 mg once daily
10980223|NCT00957996|OG000|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
10980224|NCT00957996|OG001|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
10980225|NCT00957996|OG000|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
10980226|NCT00957996|OG001|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
10980227|NCT00957996|EG000|Reported Event|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
10980228|NCT00957996|EG001|Reported Event|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
10980229|NCT00958009|BG000|Baseline|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
10980230|NCT00958009|FG000|Participant Flow|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
10980231|NCT00958009|OG000|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
10980232|NCT00958009|EG000|Reported Event|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
10980233|NCT00958035|BG000|Baseline|LATISSE®|bimatoprost ophthalmic 0.03% solution
10980234|NCT00958035|BG001|Baseline|Placebo|vehicle sterile solution
10980235|NCT00958035|BG002|Baseline|Total|Total of all reporting groups
10980236|NCT00958035|FG000|Participant Flow|LATISSE®|bimatoprost ophthalmic 0.03% solution
10980237|NCT00958035|FG001|Participant Flow|Placebo|vehicle sterile solution
10980238|NCT00958035|OG000|Outcome|LATISSE®|bimatoprost ophthalmic 0.03% solution
10980239|NCT00958035|OG001|Outcome|Placebo|vehicle sterile solution
10980240|NCT00958035|EG000|Reported Event|LATISSE®|bimatoprost ophthalmic 0.03% solution
10980241|NCT00958035|EG001|Reported Event|Placebo|vehicle sterile solution
10980242|NCT00958074|BG000|Baseline|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
10980243|NCT00958074|BG001|Baseline|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
10980244|NCT00958074|BG002|Baseline|Total|Total of all reporting groups
10980245|NCT00958074|FG000|Participant Flow|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
10980246|NCT00958074|FG001|Participant Flow|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
10980247|NCT00958074|OG000|Outcome|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
10980248|NCT00958074|OG001|Outcome|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
10980249|NCT00958074|EG000|Reported Event|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
10980250|NCT00958074|EG001|Reported Event|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
10980251|NCT00958126|BG000|Baseline|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
10980252|NCT00958126|BG001|Baseline|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980253|NCT00958126|BG002|Baseline|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980254|NCT00958126|BG003|Baseline|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980255|NCT00958126|BG004|Baseline|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
10980256|NCT00958126|BG005|Baseline|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980257|NCT00958126|BG006|Baseline|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980258|NCT00958126|BG007|Baseline|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980259|NCT00958126|BG008|Baseline|Total|Total of all reporting groups
10980260|NCT00958126|FG000|Participant Flow|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
10980261|NCT00958126|FG001|Participant Flow|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980262|NCT00958126|FG002|Participant Flow|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980263|NCT00958126|FG003|Participant Flow|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980264|NCT00958126|FG004|Participant Flow|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
10980265|NCT00958126|FG005|Participant Flow|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980266|NCT00958126|FG006|Participant Flow|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980267|NCT00958126|FG007|Participant Flow|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980268|NCT00958126|OG000|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
10980269|NCT00958126|OG001|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980270|NCT00958126|OG002|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980271|NCT00958126|OG003|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980272|NCT00958126|OG004|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
10980273|NCT00958126|OG005|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980274|NCT00958126|OG006|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980275|NCT00958126|OG007|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980276|NCT00958126|OG000|Outcome|Placebo, Age Cohorts Combined|Vaccine diluent
10980277|NCT00958126|OG001|Outcome|CSL425 (7.5 mcg), Age Cohorts Combined|7.5 mcg of hemagglutinin antigen per dose
10980278|NCT00958126|OG002|Outcome|CSL425 (15 Mcg), Age Cohorts Combined|15 mcg of hemagglutinin antigen per dose
10980279|NCT00958126|OG003|Outcome|CSL425 (30 Mcg), Age Cohorts Combined|30 mcg of hemagglutinin antigen per dose
10980280|NCT00958126|EG000|Reported Event|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
10980281|NCT00958126|EG001|Reported Event|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980282|NCT00958126|EG002|Reported Event|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980283|NCT00958126|EG003|Reported Event|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
10980284|NCT00958126|EG004|Reported Event|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
10980285|NCT00958126|EG005|Reported Event|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980286|NCT00958126|EG006|Reported Event|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980287|NCT00958126|EG007|Reported Event|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
10980288|NCT00958165|BG000|Baseline|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
10980289|NCT00958165|FG000|Participant Flow|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
10980290|NCT00958165|OG000|Outcome|EAS-AC|Pulmonary vein isolation treatment with EAS-AC for PAF
10980291|NCT00958165|EG000|Reported Event|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
10980292|NCT00958191|BG000|Baseline|Trident® X3 Polyethylene Insert|All subjects who recieved the Trident X3 insert.
10980293|NCT00958191|FG000|Participant Flow|Trident® X3 Polyethylene Insert|Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
10980294|NCT00958191|OG000|Outcome|Trident® X3 Polyethylene Insert|Participants who received theTrident® X3 Polyethylene Insert
10980295|NCT00958191|OG000|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
10980296|NCT00958191|EG000|Reported Event|Operative Adverse Events|Trident X3 Polyethylene Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.
10980297|NCT00958191|EG001|Reported Event|Non-operative Adverse Events|Trident X3 Polyethylene Insert. Non-operative site events are reported by participant.
10980298|NCT00958217|BG000|Baseline|Arm 1: CPT-M|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) were recruited.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
10980299|NCT00958217|BG001|Baseline|Arm 2: ICBT|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) were recruited.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
10980300|NCT00958217|BG002|Baseline|Total|Total of all reporting groups
10980301|NCT00958217|FG000|Participant Flow|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
10980302|NCT00958217|FG001|Participant Flow|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
10980303|NCT00958217|OG000|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
10980304|NCT00958217|OG001|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
10980305|NCT00958217|EG000|Reported Event|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
10980306|NCT00958217|EG001|Reported Event|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
10980307|NCT00958217|EG002|Reported Event|ICBT Prior to Randomization|"All participants attended 12 weeks of group Integrated Cognitive Behavioral Therapy prior to randomization to provide for a period of stabilization and to develop relapse prevention and mood management skills.~This portion will report on only those participants who were not randomized to individual CPT-M or ICBT."
10980308|NCT00958243|BG000|Baseline|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
10980309|NCT00958243|BG001|Baseline|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
10980310|NCT00958243|BG002|Baseline|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
10980311|NCT00958243|BG003|Baseline|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
10980312|NCT00958243|BG004|Baseline|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
10980313|NCT00958243|BG005|Baseline|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
10980314|NCT00958243|BG006|Baseline|Total|Total of all reporting groups
10980315|NCT00958243|FG000|Participant Flow|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
10980316|NCT00958243|FG001|Participant Flow|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
10980317|NCT00958243|FG002|Participant Flow|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
10980318|NCT00958243|FG003|Participant Flow|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
10980319|NCT00958243|FG004|Participant Flow|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
10980320|NCT00958243|FG005|Participant Flow|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
10980321|NCT00958243|OG000|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
10980322|NCT00958243|OG001|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
10980323|NCT00958243|OG002|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
10980324|NCT00958243|OG003|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
10980325|NCT00958243|OG004|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
10980326|NCT00958243|OG005|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
10980327|NCT00958243|OG000|Outcome|Placebo Cohort A|Placebo
10980328|NCT00958243|OG001|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
10980329|NCT00958243|OG002|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
10980330|NCT00958243|OG000|Outcome|Placebo Cohort B|Placebo
10980331|NCT00958243|OG001|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
10873605|NCT00428389|EG000|Reported Event|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
10873606|NCT00428389|EG001|Reported Event|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
10873607|NCT00428441|BG000|Baseline|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
10873608|NCT00428441|FG000|Participant Flow|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
10873609|NCT00428441|OG000|Outcome|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
10873610|NCT00428441|EG000|Reported Event|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
10873611|NCT00428584|BG000|Baseline|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
10873612|NCT00428584|BG001|Baseline|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
10873613|NCT00428584|BG002|Baseline|Total|Total of all reporting groups
10873614|NCT00428584|FG000|Participant Flow|New Formulation of Rebif|The new formulation of rebif is not approved and under investigation in the US
10873615|NCT00428584|FG001|Participant Flow|Betaseron|
10873616|NCT00428584|OG000|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
10873617|NCT00428584|OG001|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
10873618|NCT00428584|OG000|Outcome|New Formulation of Rebif|Human interferon beta 1a, new formualation of rebif- 44 mcg, subcutaneous injection, three times a week
10873619|NCT00428584|OG001|Outcome|Betaseron to New Formulation of Rebif|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
10873620|NCT00428584|OG000|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
10873621|NCT00428584|OG001|Outcome|Betaseron to the New Formulation of Rebif|
10873622|NCT00428584|EG000|Reported Event|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
10873623|NCT00428584|EG001|Reported Event|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
10873624|NCT00428597|BG000|Baseline|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
10873625|NCT00428597|BG001|Baseline|Placebo|Matching placebo.
10873626|NCT00428597|BG002|Baseline|Total|Total of all reporting groups
10873627|NCT00428597|FG000|Participant Flow|Sunitinib|Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule.
10873628|NCT00428597|FG001|Participant Flow|Placebo|Matching placebo.
10873629|NCT00428597|OG000|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
10873630|NCT00428597|OG001|Outcome|Placebo|Matching placebo.
10873631|NCT00428597|EG000|Reported Event|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
10873632|NCT00428597|EG001|Reported Event|Placebo|Matching placebo.
10873633|NCT00428610|BG000|Baseline|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
10873634|NCT00428610|BG001|Baseline|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
10873635|NCT00428610|BG002|Baseline|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
10873636|NCT00428610|BG003|Baseline|Total|Total of all reporting groups
10873637|NCT00428610|FG000|Participant Flow|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
10873638|NCT00428610|FG001|Participant Flow|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
10873639|NCT00428610|FG002|Participant Flow|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
10980332|NCT00958243|OG002|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
10980333|NCT00958243|EG000|Reported Event|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
10980334|NCT00958243|EG001|Reported Event|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
10980335|NCT00958243|EG002|Reported Event|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
10980336|NCT00958243|EG003|Reported Event|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
10980337|NCT00958243|EG004|Reported Event|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
10980338|NCT00958243|EG005|Reported Event|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
10980339|NCT00958256|BG000|Baseline|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
10980340|NCT00958256|FG000|Participant Flow|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, Granulocyte-colony stimulating factor (G-CSF) 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
10980341|NCT00958256|OG000|Outcome|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
10980342|NCT00958256|EG000|Reported Event|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
10980343|NCT00958282|BG000|Baseline|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
10980344|NCT00958282|BG001|Baseline|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
10980345|NCT00958282|BG002|Baseline|Total|Total of all reporting groups
10980346|NCT00958282|FG000|Participant Flow|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
10980347|NCT00958282|FG001|Participant Flow|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
10980348|NCT00958282|OG000|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
10980349|NCT00958282|OG001|Outcome|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
10980350|NCT00958282|EG000|Reported Event|Lisdexamfetamine/Behavior Therapy|"lisdexamfetamine 70mg/day plus Behavior Therapy~lisdexamfetamine/Behavior Therapy"
10980351|NCT00958282|EG001|Reported Event|Placebo|"Placebo Comparator once per day~placebo"
10980352|NCT00958308|BG000|Baseline|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980353|NCT00958308|BG001|Baseline|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980354|NCT00958308|BG002|Baseline|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
11335400|NCT03549598|BG000|Baseline|68Ga-DOTATATE PET/CT|"68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject~68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.~18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.~13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol."
10980355|NCT00958308|BG003|Baseline|Total|Total of all reporting groups
10980356|NCT00958308|FG000|Participant Flow|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980357|NCT00958308|FG001|Participant Flow|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980358|NCT00958308|FG002|Participant Flow|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980359|NCT00958308|OG000|Outcome|Placebo|Two capsules of placebo (devoid of microorganisms)per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980360|NCT00958308|OG001|Outcome|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980361|NCT00958308|OG002|Outcome|BIO-K+ CL-1285|Two capsules of probiotic (each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980362|NCT00958308|EG000|Reported Event|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980363|NCT00958308|EG001|Reported Event|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980364|NCT00958308|EG002|Reported Event|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
10980365|NCT00958334|BG000|Baseline|Proellex 25 mg|Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted.
10980366|NCT00958334|BG001|Baseline|Proellex 12.5 mg Then 25 mg|Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules.
10980367|NCT00958334|BG002|Baseline|Placebo, Then 25 mg Proellex|Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules.
10980368|NCT00958334|BG003|Baseline|Total|Total of all reporting groups
10980369|NCT00958334|FG000|Participant Flow|Proellex 25 mg|Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted.
10980370|NCT00958334|FG001|Participant Flow|Proellex 12.5 mg Then 25 mg|Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules.
10980371|NCT00958334|FG002|Participant Flow|Placebo, Then 25 mg Proellex|Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules.
10980372|NCT00958334|OG000|Outcome|Proellex 25 mg|Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted.
10980373|NCT00958334|OG001|Outcome|Proellex 12.5 mg Then 25 mg|Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules.
10980374|NCT00958334|OG002|Outcome|Placebo, Then 25 mg Proellex|Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules.
10980375|NCT00958334|EG000|Reported Event|Proellex 25 mg|Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted.
10980376|NCT00958334|EG001|Reported Event|Proellex 12.5 mg Then 25 mg|Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules.
10980377|NCT00958334|EG002|Reported Event|Placebo, Then 25 mg Proellex|Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules.
10980378|NCT00958360|BG000|Baseline|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
10980379|NCT00958360|BG001|Baseline|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
10980380|NCT00958360|BG002|Baseline|Total|Total of all reporting groups
10980381|NCT00958360|FG000|Participant Flow|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
10980382|NCT00958360|FG001|Participant Flow|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
10873640|NCT00428610|OG000|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
10873641|NCT00428610|OG001|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
10873642|NCT00428610|OG002|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
10873643|NCT00428610|EG000|Reported Event|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
10873644|NCT00428610|EG001|Reported Event|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
10873645|NCT00428610|EG002|Reported Event|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
10873646|NCT00428714|BG000|Baseline|Enzastaurin-Cohort 1|Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873647|NCT00428714|BG001|Baseline|Enzastaurin-Cohort 2|Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873648|NCT00428714|BG002|Baseline|Total|Total of all reporting groups
10873649|NCT00428714|FG000|Participant Flow|Enzastaurin-Cohort 1|Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873650|NCT00428714|FG001|Participant Flow|Enzastaurin-Cohort 2|Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873651|NCT00428714|OG000|Outcome|Enzastaurin-Cohort 1|Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873652|NCT00428714|OG000|Outcome|Enzastaurin-Cohort 2|Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873653|NCT00428714|OG000|Outcome|LY317615- Cohort 1|Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873654|NCT00428714|EG000|Reported Event|Enzastaurin-Cohort 1|Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873655|NCT00428714|EG001|Reported Event|Enzastaurin-Cohort 2|Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
10873656|NCT00428792|BG000|Baseline|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
10873657|NCT00428792|BG001|Baseline|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
10873658|NCT00428792|BG002|Baseline|Total|Total of all reporting groups
10873659|NCT00428792|FG000|Participant Flow|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
10980383|NCT00958360|OG000|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
10980384|NCT00958360|OG001|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
10980385|NCT00958360|EG000|Reported Event|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
10980386|NCT00958360|EG001|Reported Event|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
10980387|NCT00958412|BG000|Baseline|Proellex®|Proellex®: one (1) 25 mg capsule daily
10980388|NCT00958412|FG000|Participant Flow|Proellex|Proellex: one (1) 25 mg capsule daily Study was terminated prematurely and no data is available
10980389|NCT00958412|OG000|Outcome|Proellex®|Proellex®: one (1) 25 mg capsule daily
10980390|NCT00958412|EG000|Reported Event|Proellex®|Proellex®: one (1) 25 mg capsule daily No data available
10980391|NCT00958438|BG000|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
10980392|NCT00958438|BG001|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
10980393|NCT00958438|BG002|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10980394|NCT00958438|BG003|Baseline|Total|Total of all reporting groups
10980395|NCT00958438|FG000|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
10980396|NCT00958438|FG001|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
10980397|NCT00958438|FG002|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10980398|NCT00958438|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
10980399|NCT00958438|OG001|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
10980400|NCT00958438|OG002|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10980401|NCT00958438|EG000|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
10980402|NCT00958438|EG001|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
10980403|NCT00958438|EG002|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10980404|NCT00958477|BG000|Baseline|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980405|NCT00958477|BG001|Baseline|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980406|NCT00958477|BG002|Baseline|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
11336370|NCT03565315|EG001|Reported Event|Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1."
10980407|NCT00958477|BG003|Baseline|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980408|NCT00958477|BG004|Baseline|Total|Total of all reporting groups
10980409|NCT00958477|FG000|Participant Flow|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980410|NCT00958477|FG001|Participant Flow|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980411|NCT00958477|FG002|Participant Flow|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980412|NCT00958477|FG003|Participant Flow|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980413|NCT00958477|OG000|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980414|NCT00958477|OG001|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980415|NCT00958477|OG002|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980416|NCT00958477|OG003|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980417|NCT00958477|OG003|Outcome|EMD 525797 1500 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
11223187|NCT02351700|OG000|Outcome|Opioid-sparing Group|"Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.~IV Caldolor (IV Ibuprofen): Compare addition of IV Caldolor (IV ibuprofen) intraoperatively and postoperatively against IV ibuprofen placebo added intraoperatively and postoperatively."
10980418|NCT00958477|OG000|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980419|NCT00958477|OG001|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980420|NCT00958477|OG002|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980421|NCT00958477|OG003|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980422|NCT00958477|OG003|Outcome|EMD 525797 1500 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980423|NCT00958477|EG000|Reported Event|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980424|NCT00958477|EG001|Reported Event|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980425|NCT00958477|EG002|Reported Event|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980426|NCT00958477|EG003|Reported Event|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
10980427|NCT00958568|BG000|Baseline|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
10980428|NCT00958568|FG000|Participant Flow|OFC (SPII )|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
10980429|NCT00958568|FG001|Participant Flow|OFC (SPIII)|6 mg Olanzapine and 25 mg Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
10980430|NCT00958568|FG002|Participant Flow|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
10980431|NCT00958568|FG003|Participant Flow|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
10980432|NCT00958568|OG000|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
10980433|NCT00958568|OG001|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
10980434|NCT00958568|OG000|Outcome|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
10980435|NCT00958568|OG000|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
10980436|NCT00958568|OG000|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
10980437|NCT00958568|EG000|Reported Event|OFC (SPII)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
10980438|NCT00958568|EG001|Reported Event|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
10980439|NCT00958568|EG002|Reported Event|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
10980440|NCT00958568|EG003|Reported Event|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
10980441|NCT00958581|BG000|Baseline|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
10980442|NCT00958581|BG001|Baseline|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline :"
10980443|NCT00958581|BG002|Baseline|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
10980444|NCT00958581|BG003|Baseline|Total|Total of all reporting groups
10980445|NCT00958581|FG000|Participant Flow|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
10980446|NCT00958581|FG001|Participant Flow|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline :"
10980447|NCT00958581|FG002|Participant Flow|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
11098969|NCT01579084|FG000|Participant Flow|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
10980448|NCT00958581|OG000|Outcome|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
10980449|NCT00958581|OG001|Outcome|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline :"
10980450|NCT00958581|OG002|Outcome|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
10980451|NCT00958581|OG000|Outcome|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline: Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose."
10980452|NCT00958581|OG001|Outcome|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid: For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
10980453|NCT00958581|OG002|Outcome|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid: For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
10980454|NCT00958581|EG000|Reported Event|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
10980455|NCT00958581|EG001|Reported Event|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline :"
10980456|NCT00958581|EG002|Reported Event|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
10980457|NCT00958711|BG000|Baseline|Biologic - Unite Biomatrix|Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
10980458|NCT00958711|BG001|Baseline|Saline and Gauze|Saline and Gauze: gauze moistened with sterile saline
10980459|NCT00958711|BG002|Baseline|Total|Total of all reporting groups
10980460|NCT00958711|FG000|Participant Flow|Biologic - Unite Biomatrix|Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
10980461|NCT00958711|FG001|Participant Flow|Saline and Gauze|Saline and Gauze: gauze moistened with sterile saline
10980462|NCT00958711|OG000|Outcome|Biologic - Unite Biomatrix|Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
10980463|NCT00958711|OG001|Outcome|Saline and Gauze|Saline and Gauze: gauze moistened with sterile saline
10980464|NCT00958711|EG000|Reported Event|Biologic - Unite Biomatrix|Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
10980465|NCT00958711|EG001|Reported Event|Saline and Gauze|Saline and Gauze: gauze moistened with sterile saline
10980466|NCT00958724|BG000|Baseline|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m^2
10980467|NCT00958724|FG000|Participant Flow|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m^2
10980468|NCT00958724|OG000|Outcome|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m^2
10980469|NCT00958724|EG000|Reported Event|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m^2
10980470|NCT00958776|BG000|Baseline|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
10980471|NCT00958776|BG001|Baseline|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
10980472|NCT00958776|BG002|Baseline|Total|Total of all reporting groups
10980473|NCT00958776|FG000|Participant Flow|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
10980474|NCT00958776|FG001|Participant Flow|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
10980475|NCT00958776|OG000|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
10980476|NCT00958776|OG001|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
10980477|NCT00958776|OG001|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
10980478|NCT00958776|EG000|Reported Event|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
10980479|NCT00958776|EG001|Reported Event|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
10980480|NCT00958789|BG000|Baseline|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
10980481|NCT00958789|FG000|Participant Flow|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
10980482|NCT00958789|OG000|Outcome|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
10980483|NCT00958789|OG000|Outcome|Joint Line Restoration (JLR) ≤ 5 mm|The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
10980484|NCT00958789|OG001|Outcome|Joint Line Restoration (JLR) > 5 mm|The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
10980485|NCT00958789|OG001|Outcome|Joint Line Restoration (JLR) > 5mm|The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
10980486|NCT00958789|OG000|Outcome|Triathlon TS Knee|"Triathlon TS Knee System~Triathlon TS Knee System: Total knee replacement for revision cases"
10980487|NCT00958789|EG000|Reported Event|Operative Adverse Events|"Triathlon TS Knee System: Total knee replacement for revision cases~Operative site events are reported by knee because in the case of bilateral participants (this is when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately for this reason."
10980488|NCT00958789|EG001|Reported Event|Non-Operative Adverse Events|"Triathlon TS Knee System: Total knee replacement for revision cases~Non-Operative Site Events are reported by participant."
10980489|NCT00958828|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
10980490|NCT00958828|FG000|Participant Flow|Nelfilcon A / Narafilcon A|Nelfilcon A contact lenses, then Narafilcon A contact lenses
10980491|NCT00958828|FG001|Participant Flow|Narafilcon A / Nelfilcon A|Narafilcon A contact lenses, then Nelfilcon A contact lenses
10980492|NCT00958828|OG000|Outcome|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
10980493|NCT00958828|OG001|Outcome|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
10980494|NCT00958828|EG000|Reported Event|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
10980495|NCT00958828|EG001|Reported Event|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
10980496|NCT00958841|BG000|Baseline|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
10980497|NCT00958841|FG000|Participant Flow|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
10980498|NCT00958841|OG000|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
10980499|NCT00958841|OG001|Outcome|VIpoma|One of the 10 types of PNETs analyzed.
10980500|NCT00958841|OG002|Outcome|Glucagonoma|One of the 10 types of PNETs analyzed.
10980501|NCT00958841|OG001|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
10980502|NCT00958841|OG002|Outcome|Nelson's Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
10980503|NCT00958841|OG000|Outcome|All PNETS (Gastrinoma)|One of the 10 types of PNETs analyzed
10980504|NCT00958841|OG000|Outcome|All PiNETS (Prolactinoma)|One of the 10 types of PiNETs analyzed
10980505|NCT00958841|OG000|Outcome|Nelson's Syndrome|Nelson's syndrome is associated with local tumor extension or invasion following a therapeutic bilateral adrenalectomy
10980506|NCT00958841|EG000|Reported Event|Pancreatic NETs (PNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
10980507|NCT00958841|EG001|Reported Event|Pituitary NETs (PiNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
10980508|NCT00958841|EG002|Reported Event|Ectopic ACTH-secrting Tumors (EAS)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
10980509|NCT00958841|EG003|Reported Event|Nelsons Syndrome|Nelson's syndrome is based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48.
10980510|NCT00958880|BG000|Baseline|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
10980511|NCT00958880|BG001|Baseline|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
10980512|NCT00958880|BG002|Baseline|Total|Total of all reporting groups
10980513|NCT00958880|FG000|Participant Flow|Sugar Pill|Participants received placebo (sugar pill) augmented Group Cognitive Behavioral Therapy. The pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
10980514|NCT00958880|FG001|Participant Flow|Yohimbine Hydrochloride|Participants received Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy. Participants received Yohimbine HCL augmented Group Cognitive Behavioral Therapy. The 10.8 mg pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
10980515|NCT00958880|OG000|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
10980516|NCT00958880|OG001|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
10980517|NCT00958880|EG000|Reported Event|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
11348159|NCT04207840|FG000|Participant Flow|A-B-C|Subjects received one of the three treatments during each study visit. Visit 1: Treatment A: Two (2) inhalations of Primatene Mist (0.125 mg of epinephrine per inhalation), for a total dosage of 0.25 mg; Visit 2: Treatment B: Intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL), for a total dosage of 0.30 mg; Visit 3: Treatment C: Two (2) inhalations of Albuterol HFA (0.09 mg of albuterol sulfate per inhalation), for a total dosage of 0.18 mg.
10848648|NCT00290745|OG000|Outcome|Tamoxifen or Letrozole|"tamoxifen or letrozole work in treating women with ductal carcinoma in situ~letrozole~tamoxifen citrate~conventional surgery~neoadjuvant therapy"
10980518|NCT00958880|EG001|Reported Event|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
10980519|NCT00958919|BG000|Baseline|Entire Study Population|Includes groups randomized to receive saline first and Naxolone first.
10980520|NCT00958919|FG000|Participant Flow|Normal Saline First, Then Naloxone|Intravenous saline (25 ml) in first intervention period and intravenous Naloxone (10mg/25 ml) in second intervention period.
10980521|NCT00958919|FG001|Participant Flow|Naloxone First, Then Normal Saline|Intravenous Naloxone (10mg/25 ml)in first intervention period and intravenous saline (25 ml) in second intervention period.
10980522|NCT00958919|OG000|Outcome|Normal Saline|Intravenous saline (25 ml)
10980523|NCT00958919|OG001|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)
10980524|NCT00958919|OG001|Outcome|Naloxone|Intravension Naloxone (10mg/25ml)
10980525|NCT00958919|OG000|Outcome|Normal Saline|Intravenous saline (25 ml) given prior to start of Resistive Load Breathing
10980526|NCT00958919|OG001|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)given prior to start of Resistive Load Breathing
10980527|NCT00958919|OG000|Outcome|Baseline|Pre-infusion of Naloxone (10 mg/25 ml)
10980528|NCT00958919|OG001|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Naloxone (10 mg/25 ml)
10980529|NCT00958919|OG000|Outcome|Baseline|Pre-infusion of Normal Saline (25 ml)
10980530|NCT00958919|OG001|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Normal Saline (25 ml)
10980531|NCT00958919|EG000|Reported Event|Normal Saline|25 ml Intravenous
10980532|NCT00958919|EG001|Reported Event|Naloxone|10mg/25ml Intravenous
10980533|NCT00959049|BG000|Baseline|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
10980534|NCT00959049|BG001|Baseline|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
10980535|NCT00959049|BG002|Baseline|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
10980536|NCT00959049|BG003|Baseline|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980537|NCT00959049|BG004|Baseline|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980538|NCT00959049|BG005|Baseline|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980539|NCT00959049|BG006|Baseline|Total|Total of all reporting groups
10980540|NCT00959049|FG000|Participant Flow|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
10980541|NCT00959049|FG001|Participant Flow|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
10980542|NCT00959049|FG002|Participant Flow|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
10980543|NCT00959049|FG003|Participant Flow|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980544|NCT00959049|FG004|Participant Flow|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980545|NCT00959049|FG005|Participant Flow|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980546|NCT00959049|OG000|Outcome|Afluria Cohort A|Age 6 months to < 3 years
10980547|NCT00959049|OG001|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
10980548|NCT00959049|OG000|Outcome|Afluria Cohort B|Age 3 to < 9 years
10980549|NCT00959049|OG001|Outcome|Fluzone Cohort B|Age 3 to < 9 years
10980550|NCT00959049|OG000|Outcome|Afluria Cohort C|Age 9 to < 18 years
10980551|NCT00959049|OG001|Outcome|Fluzone Cohort C|Age 9 to < 18 years
10980552|NCT00959049|OG000|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
10980553|NCT00959049|OG001|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
10980554|NCT00959049|OG002|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
10980555|NCT00959049|OG003|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980556|NCT00959049|OG004|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980557|NCT00959049|OG005|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980558|NCT00959049|OG001|Outcome|Afluria Cohort B|Age 3 to < 9 years
10980559|NCT00959049|OG002|Outcome|Afluria Cohort C|Age 9 to < 18 years
10980560|NCT00959049|OG003|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
10980561|NCT00959049|OG004|Outcome|Fluzone Cohort B|Age 3 to < 9 years
10980562|NCT00959049|OG005|Outcome|Fluzone Cohort C|Age 3 to < 9 years
10980563|NCT00959049|EG000|Reported Event|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
10980564|NCT00959049|EG001|Reported Event|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
10980565|NCT00959049|EG002|Reported Event|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
10980566|NCT00959049|EG003|Reported Event|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980567|NCT00959049|EG004|Reported Event|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980568|NCT00959049|EG005|Reported Event|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
10980569|NCT00959166|BG000|Baseline|HIV/Acute HCV Coinfection|Subjects with HIV/acute HCV coinfection
10980570|NCT00959166|BG001|Baseline|HIV Mono|HIV-infected individuals without hepatitis C co-infection
10980571|NCT00959166|BG002|Baseline|Total|Total of all reporting groups
10980572|NCT00959166|FG000|Participant Flow|HIV/Acute HCV Coinfection|Subjects with HIV/acute HCV coinfection
10980573|NCT00959166|FG001|Participant Flow|HIV Mono|HIV-infected individuals without hepatitis C co-infection
10980574|NCT00959166|OG000|Outcome|HIV/Acute HCV Coinfection|Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.
10980575|NCT00959166|OG001|Outcome|HIV Mono|HIV-infected individuals without hepatitis C co-infection
10980576|NCT00959166|EG000|Reported Event|HIV/Acute HCV Coinfection|Subjects with HIV/acute HCV coinfection
10980577|NCT00959166|EG001|Reported Event|HIV Mono|HIV-infected individuals without hepatitis C co-infection
10980578|NCT00959192|BG000|Baseline|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980579|NCT00959192|BG001|Baseline|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980580|NCT00959192|BG002|Baseline|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980581|NCT00959192|BG003|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980582|NCT00959192|BG004|Baseline|Total|Total of all reporting groups
11336371|NCT03565315|EG002|Reported Event|Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
10980583|NCT00959192|FG000|Participant Flow|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980584|NCT00959192|FG001|Participant Flow|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980585|NCT00959192|FG002|Participant Flow|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980586|NCT00959192|FG003|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980587|NCT00959192|OG000|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980588|NCT00959192|OG001|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980589|NCT00959192|OG002|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980590|NCT00959192|OG003|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980591|NCT00959192|OG000|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10980592|NCT00959192|EG000|Reported Event|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980593|NCT00959192|EG001|Reported Event|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980594|NCT00959192|EG002|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980595|NCT00959192|EG003|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10980596|NCT00959374|BG000|Baseline|V-loc and Monocryl|All randomized subjects
10980597|NCT00959374|FG000|Participant Flow|V-loc and Monocryl|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
10980598|NCT00959374|OG000|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
10980599|NCT00959374|OG001|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
10980600|NCT00959374|EG000|Reported Event|V-Loc 180 / 90|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
10980601|NCT00959374|EG001|Reported Event|Control - Monocryl 3-0|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
10980602|NCT00959374|EG002|Reported Event|Midline|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at midline incision and therefore not assigned to a treatment arm.
10980603|NCT00959374|EG003|Reported Event|Non-protocol Incision or Systemic Events|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at either a non-protocol incision or were systemic in nature.
10980604|NCT00959647|BG000|Baseline|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
10980605|NCT00959647|FG000|Participant Flow|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
10980606|NCT00959647|OG000|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
10980607|NCT00959647|EG000|Reported Event|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
10980608|NCT00959660|BG000|Baseline|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
10980609|NCT00959660|BG001|Baseline|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
10980610|NCT00959660|BG002|Baseline|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
10980611|NCT00959660|BG003|Baseline|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
10980612|NCT00959660|BG004|Baseline|Total|Total of all reporting groups
10980613|NCT00959660|FG000|Participant Flow|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
10980614|NCT00959660|FG001|Participant Flow|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
10980615|NCT00959660|FG002|Participant Flow|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
10980616|NCT00959660|FG003|Participant Flow|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
10980617|NCT00959660|OG000|Outcome|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
10980618|NCT00959660|OG001|Outcome|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
10980619|NCT00959660|OG002|Outcome|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
10980620|NCT00959660|OG003|Outcome|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
10980621|NCT00959660|EG000|Reported Event|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
10980622|NCT00959660|EG001|Reported Event|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
10980623|NCT00959660|EG002|Reported Event|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
10980624|NCT00959660|EG003|Reported Event|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
10980625|NCT00959699|BG000|Baseline|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
10980626|NCT00959699|BG001|Baseline|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
10980627|NCT00959699|BG002|Baseline|Total|Total of all reporting groups
10980628|NCT00959699|FG000|Participant Flow|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
10980629|NCT00959699|FG001|Participant Flow|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
10980630|NCT00959699|OG000|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
10980631|NCT00959699|OG001|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
10980632|NCT00959699|EG000|Reported Event|PegIFN-2b+RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
10980633|NCT00959699|EG001|Reported Event|PegIFN-2b+RBV+Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
10980634|NCT00959699|EG002|Reported Event|Boceprevir Crossover|(After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up.
10980635|NCT00959751|BG000|Baseline|NXN-188|3 x 200 mg capsules
10980636|NCT00959751|BG001|Baseline|Placebo|3 x 0 mg capsules
10980637|NCT00959751|BG002|Baseline|Total|Total of all reporting groups
10980638|NCT00959751|FG000|Participant Flow|Placebo|3 x capsules, PRN
10848649|NCT00290745|EG000|Reported Event|Tamoxifen or Letrozole|"tamoxifen or letrozole work in treating women with ductal carcinoma in situ~letrozole~tamoxifen citrate~conventional surgery~neoadjuvant therapy"
10980639|NCT00959751|FG001|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules, PRN
10980640|NCT00959751|OG000|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
10980641|NCT00959751|OG001|Outcome|Placebo|3 x 0 mg capsules, PRN
10980642|NCT00959751|EG000|Reported Event|NXN-188 600 mg|3 x 200 mg capsules, PRN
10980643|NCT00959751|EG001|Reported Event|Placebo|3 x 0 mg capsules, PRN
10980644|NCT00959764|BG000|Baseline|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
10980645|NCT00959764|BG001|Baseline|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
10980646|NCT00959764|BG002|Baseline|Placebo|Patients who did not receive any active treatment
10980647|NCT00959764|BG003|Baseline|Total|Total of all reporting groups
10980648|NCT00959764|FG000|Participant Flow|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
10980649|NCT00959764|FG001|Participant Flow|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
10980650|NCT00959764|FG002|Participant Flow|Placebo|Patients who did not receive any active treatment
10980651|NCT00959764|OG000|Outcome|Oral Calcitonin|Patients who were provided active oral calcitonin and placebo nasal medication in a blinded fashion.
10980652|NCT00959764|OG001|Outcome|Nasal Calcitonin|Patients who were provided active nasal calcitonin and placebo oral medication in a blinded fashion.
10980653|NCT00959764|OG002|Outcome|Placebo|Patients who were provided nasal and oral placebo medication in a blinded fashion
10980654|NCT00959764|OG000|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
10980655|NCT00959764|OG001|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
10980656|NCT00959764|OG002|Outcome|Placebo|Patients who did not receive any active treatment
10980657|NCT00959764|EG000|Reported Event|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
10980658|NCT00959764|EG001|Reported Event|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
10980659|NCT00959764|EG002|Reported Event|Placebo|Patients who did not receive any active treatment
10980660|NCT00959842|BG000|Baseline|Lovaza|Lovaza was given as the only agent; there was no comparator agent or arm Lovaza: 1 gram gel capsule 4 capsules per day for 8 weeks
10980661|NCT00959842|FG000|Participant Flow|Lovaza|"Lovaza was given as the only agent; there was no comparator agent or arm~Lovaza: 1 gram gel capsule 4 capsules per day for 8 weeks"
10980662|NCT00959842|OG000|Outcome|Lovaza|Lovaza was given as the only agent; there was no comparator agent or arm Lovaza: 1 gram gel capsule 4 capsules per day for 8 weeks
10980663|NCT00959842|EG000|Reported Event|Treatment Group|all patients were treated with n3
10980664|NCT00959894|BG000|Baseline|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
10980665|NCT00959894|FG000|Participant Flow|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
10980666|NCT00959894|OG000|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
10980667|NCT00959894|OG000|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day~Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
10980668|NCT00959894|EG000|Reported Event|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
10980669|NCT00959907|BG000|Baseline|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
10980670|NCT00959907|BG001|Baseline|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
10980671|NCT00959907|BG002|Baseline|Total|Total of all reporting groups
10980672|NCT00959907|FG000|Participant Flow|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
10980673|NCT00959907|FG001|Participant Flow|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
10980674|NCT00959907|OG000|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
10980675|NCT00959907|OG001|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
10980676|NCT00959907|EG000|Reported Event|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
10980677|NCT00959907|EG001|Reported Event|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
10980678|NCT00959920|BG000|Baseline|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
10980679|NCT00959920|BG001|Baseline|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
10980680|NCT00959920|BG002|Baseline|Total|Total of all reporting groups
10980681|NCT00959920|FG000|Participant Flow|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
10980682|NCT00959920|FG001|Participant Flow|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
10980683|NCT00959920|OG000|Outcome|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
10980684|NCT00959920|OG001|Outcome|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
10980685|NCT00959920|OG000|Outcome|Indwelling Foley Catheter|"Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.~Indwelling catheter: Indwelling bladder catheter will remain in place until time of delivery."
10980686|NCT00959920|OG001|Outcome|Intermittent Straight Catheterization|"Intermittent straight catheterization will be performed as needed during labor.~Intermittent straight catheterization: intermittent straight catheterization will be performed on an as needed basis until time of delivery."
10980687|NCT00959920|EG000|Reported Event|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
10980688|NCT00959920|EG001|Reported Event|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
10980689|NCT00959946|BG000|Baseline|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10980690|NCT00959946|BG001|Baseline|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980691|NCT00959946|BG002|Baseline|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980692|NCT00959946|BG003|Baseline|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980693|NCT00959946|BG004|Baseline|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980694|NCT00959946|BG005|Baseline|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980695|NCT00959946|BG006|Baseline|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980696|NCT00959946|BG007|Baseline|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980697|NCT00959946|BG008|Baseline|Total|Total of all reporting groups
10980698|NCT00959946|FG000|Participant Flow|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10980699|NCT00959946|FG001|Participant Flow|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980700|NCT00959946|FG002|Participant Flow|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980701|NCT00959946|FG003|Participant Flow|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980702|NCT00959946|FG004|Participant Flow|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980703|NCT00959946|FG005|Participant Flow|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980704|NCT00959946|FG006|Participant Flow|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980705|NCT00959946|FG007|Participant Flow|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980706|NCT00959946|OG000|Outcome|Bosutinib + Capecitabine 625 mg/m^2|Bosutinib 200 mg, or 300 mg, tablet administered orally once daily in a 21-day cycle. Capecitabine 625 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980707|NCT00959946|OG001|Outcome|Bosutinib + Capecitabine 750 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 750 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10873660|NCT00428792|FG001|Participant Flow|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
10873661|NCT00428792|OG000|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
10873662|NCT00428792|OG001|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
10873663|NCT00428792|EG000|Reported Event|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
10873664|NCT00428792|EG001|Reported Event|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
10873665|NCT00428844|BG000|Baseline|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
10873666|NCT00428844|BG001|Baseline|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
10873667|NCT00428844|BG002|Baseline|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
10873668|NCT00428844|BG003|Baseline|Total|Total of all reporting groups
10873669|NCT00428844|FG000|Participant Flow|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
10873670|NCT00428844|FG001|Participant Flow|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
10873671|NCT00428844|FG002|Participant Flow|Comparator|Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
10873672|NCT00428844|OG000|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
10873673|NCT00428844|OG001|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
10873674|NCT00428844|OG002|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
10873675|NCT00428844|EG000|Reported Event|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
10873676|NCT00428844|EG001|Reported Event|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
10873677|NCT00428844|EG002|Reported Event|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
10873678|NCT00428922|BG000|Baseline|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
10873679|NCT00428922|FG000|Participant Flow|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
10873680|NCT00428922|OG000|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
10873681|NCT00428922|EG000|Reported Event|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
10873682|NCT00428948|BG000|Baseline|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
10873683|NCT00428948|BG001|Baseline|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
10873684|NCT00428948|BG002|Baseline|Total|Total of all reporting groups
10873685|NCT00428948|FG000|Participant Flow|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
10873686|NCT00428948|FG001|Participant Flow|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
10873687|NCT00428948|OG000|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
10873688|NCT00428948|OG001|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
10873689|NCT00428948|EG000|Reported Event|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
10873690|NCT00428948|EG001|Reported Event|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
10873691|NCT00428974|BG000|Baseline|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
10873692|NCT00428974|BG001|Baseline|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
10873693|NCT00428974|BG002|Baseline|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
10873694|NCT00428974|BG003|Baseline|Placebo|Oral tablets given every 12 hours for 12 weeks
10873695|NCT00428974|BG004|Baseline|Total|Total of all reporting groups
10873696|NCT00428974|FG000|Participant Flow|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
10873697|NCT00428974|FG001|Participant Flow|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
10873698|NCT00428974|FG002|Participant Flow|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
10873699|NCT00428974|FG003|Participant Flow|Placebo|Oral tablets given every 12 hours for 12 weeks
10873700|NCT00428974|OG000|Outcome|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
10873701|NCT00428974|OG001|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
10873702|NCT00428974|OG002|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
10873703|NCT00428974|OG003|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
10873704|NCT00428974|OG000|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
10873705|NCT00428974|EG000|Reported Event|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
10873706|NCT00428974|EG001|Reported Event|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
10873707|NCT00428974|EG002|Reported Event|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
10873708|NCT00428974|EG003|Reported Event|Placebo|Oral tablets given every 12 hours for 12 weeks
10873709|NCT00429104|BG000|Baseline|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
10873710|NCT00429104|FG000|Participant Flow|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
10873711|NCT00429104|OG000|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
10873712|NCT00429104|EG000|Reported Event|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
10873713|NCT00429143|BG000|Baseline|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
10873714|NCT00429143|FG000|Participant Flow|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
10873715|NCT00429143|OG000|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
10873716|NCT00429143|EG000|Reported Event|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
10873717|NCT00429169|BG000|Baseline|Paroxetine|Participants will receive paroxetine for 8 weeks
10873718|NCT00429169|BG001|Baseline|Bupropion|Participants will receive bupropion for 8 weeks
10873719|NCT00429169|BG002|Baseline|Total|Total of all reporting groups
10873720|NCT00429169|FG000|Participant Flow|Paroxetine|Participants will receive paroxetine for 8 weeks
10873721|NCT00429169|FG001|Participant Flow|Bupropion|Participants will receive bupropion for 8 weeks
10873722|NCT00429169|OG000|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
10873723|NCT00429169|OG001|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
10873724|NCT00429169|OG000|Outcome|Paroxetine|Paroxetine acute treatment for 8 weeks.
10873725|NCT00429169|OG001|Outcome|Bupropion|Bupropion acute treatment for 8 weeks.
10873726|NCT00429169|EG000|Reported Event|Paroxetine|Participants will receive paroxetine for 8 weeks
10873727|NCT00429169|EG001|Reported Event|Bupropion|Participants will receive bupropion for 8 weeks
10873728|NCT00429182|BG000|Baseline|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
10873729|NCT00429182|FG000|Participant Flow|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target area under the curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
10873730|NCT00429182|OG000|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
10873731|NCT00429182|EG000|Reported Event|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
10873732|NCT00429273|BG000|Baseline|Group 1: Guan-Guan+Placebo|weeks 1-4: Guanfacine weeks 5-8: Guanfacine +Placebo
10873733|NCT00429273|BG001|Baseline|Group 2: Placebo-Placebo+DMPH|weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
10873734|NCT00429273|BG002|Baseline|Group 3: Guan-Guan+DMPH (Comb)|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
10873735|NCT00429273|BG003|Baseline|Total|Total of all reporting groups
11098970|NCT01579084|FG001|Participant Flow|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
10873736|NCT00429273|FG000|Participant Flow|Group 1: Guan-Guan+Placebo|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
10873737|NCT00429273|FG001|Participant Flow|Group 2: Placebo-Placebo+DMPH|weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
10873738|NCT00429273|FG002|Participant Flow|Group 3: Guan-Guan+DMPH|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
10873739|NCT00429273|OG000|Outcome|Estimated Difference Between Guan and Placebo|Contrasts based on all observations of patients treated with guam and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for guan are based on the guan-guan arm both at 4 weeks and 8 weeks, and the guan-combo arm at 4 weeks only. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
10873740|NCT00429273|OG001|Outcome|Estimated Difference Between DMPH and Placebo|Contrasts based on all observations of patients treated with dmph and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for DMPH are based on the placebo-guan arm at 8 weeks. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
10873741|NCT00429273|OG002|Outcome|Estimated Difference Between Placebo and Combo|Contrasts based on all observations of patients treated with combo and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for DMPH are based on the guan-combo arm at 8 weeks. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
10873742|NCT00429273|EG000|Reported Event|Group 1: Guan-Guan+Placebo|week 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
10873743|NCT00429273|EG001|Reported Event|Group 2: Placebo-Placebo+DMPH|week 1-4: Placebo week 5-8: Placebo+DMPH
10873744|NCT00429273|EG002|Reported Event|Group 3: Guan-Guan+DMPH|week 1-4: Guanfacine week 5-8: Guanfacine+DMPH (comb)
10873745|NCT00429299|BG000|Baseline|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
10873746|NCT00429299|BG001|Baseline|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
10873747|NCT00429299|BG002|Baseline|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
10873748|NCT00429299|BG003|Baseline|Total|Total of all reporting groups
10873749|NCT00429299|FG000|Participant Flow|Chemotherapy (CT) Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
10873750|NCT00429299|FG001|Participant Flow|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
10873751|NCT00429299|FG002|Participant Flow|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
10980708|NCT00959946|OG002|Outcome|Bosutinib + Capecitabine 1000 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 1000 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980709|NCT00959946|OG000|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10980710|NCT00959946|OG001|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980711|NCT00959946|OG002|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980712|NCT00959946|OG003|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980713|NCT00959946|OG004|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980714|NCT00959946|OG005|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980715|NCT00959946|OG006|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980716|NCT00959946|OG007|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980717|NCT00959946|OG000|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
10980718|NCT00959946|OG001|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
10980719|NCT00959946|EG000|Reported Event|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10980720|NCT00959946|EG001|Reported Event|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980721|NCT00959946|EG002|Reported Event|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980722|NCT00959946|EG003|Reported Event|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980723|NCT00959946|EG004|Reported Event|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980724|NCT00959946|EG005|Reported Event|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980725|NCT00959946|EG006|Reported Event|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980726|NCT00959946|EG007|Reported Event|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
10980727|NCT00959985|BG000|Baseline|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
10980728|NCT00959985|BG001|Baseline|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
10980729|NCT00959985|BG002|Baseline|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
10980730|NCT00959985|BG003|Baseline|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
10980731|NCT00959985|BG004|Baseline|Total|Total of all reporting groups
10980732|NCT00959985|FG000|Participant Flow|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
10980733|NCT00959985|FG001|Participant Flow|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
10980734|NCT00959985|FG002|Participant Flow|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
10980735|NCT00959985|FG003|Participant Flow|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
10980736|NCT00959985|OG000|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
10980737|NCT00959985|OG001|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
10980738|NCT00959985|OG002|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
10980739|NCT00959985|OG003|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
10980740|NCT00959985|EG000|Reported Event|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
10980741|NCT00959985|EG001|Reported Event|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
10980742|NCT00959985|EG002|Reported Event|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
10980743|NCT00959985|EG003|Reported Event|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
10980744|NCT00960011|BG000|Baseline|PROGRIP|"Use of PROGRIP mesh for open inguinal hernia repair~PROGRIP: Use of PROGRIP mesh for open inguinal hernia repair"
10980745|NCT00960011|BG001|Baseline|POLYPROPYLENE|"Use of Polypropylene mesh for open inguinal hernia repair~POLYPROPYLENE: Use of Polypropylene mesh in open inguinal hernia repair"
10980746|NCT00960011|BG002|Baseline|Total|Total of all reporting groups
10980747|NCT00960011|FG000|Participant Flow|PROGRIP|"Use of PROGRIP mesh for open inguinal hernia repair~PROGRIP: Use of PROGRIP mesh for open inguinal hernia repair"
10980748|NCT00960011|FG001|Participant Flow|POLYPROPYLENE|"Use of Polypropylene mesh for open inguinal hernia repair~POLYPROPYLENE: Use of Polypropylene mesh in open inguinal hernia repair"
10980749|NCT00960011|OG000|Outcome|PROGRIP(PG)|It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
10980750|NCT00960011|OG001|Outcome|POLYPROPYLENE(PL)|It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
10980751|NCT00960011|OG000|Outcome|POLYPROPYLENE (PL)|It measured from the time that the POLYPROPYLENE mesh is placed over inguinal canal for fixation to the time when operation finished in terms of minutes.
10980752|NCT00960011|OG001|Outcome|PROGRIP (PG)|It measured from the time that the PROGRIP mesh is placed over inguinal canal for fixation to the time when operation finished in terms of minutes.
10980753|NCT00960011|OG000|Outcome|PROGRIP|Patient developed seroma clinically at 1 week after operation
10980754|NCT00960011|OG001|Outcome|POLYPROPYLENE|Patient developed seroma clinically at 1 week after operation
10980755|NCT00960011|OG000|Outcome|PROGRIP|Patient developed recurrence anytime from immediate post-op to 6 years after operation
10980756|NCT00960011|OG001|Outcome|POLYPROPYLENE|Patient developed recurrence anytime from immediate post-op to 6 years after operation
10980757|NCT00960011|OG000|Outcome|PROGRIP|Patient with persistent chronic pain 6 years after operation
10980758|NCT00960011|OG001|Outcome|POLYPROPYLENE|Patient with persistent chronic pain 6 years after operation
10980759|NCT00960011|OG000|Outcome|PROGRIP|Patient with testicular atrophy from post-op to 6 years after operations
10980760|NCT00960011|OG001|Outcome|POLYPROPYLENE|Patient with testicular atrophy from post-op to 6 years after operations
10980761|NCT00960011|OG000|Outcome|PROGRIP|Patient with palpable mesh at 6 years after operation
10980762|NCT00960011|OG001|Outcome|POLYPROPYLENE|Patient with palpable mesh at 6 years after operation
10980763|NCT00960011|OG000|Outcome|PROGRIP|Patient with chronic discomfort at 6 years after operation
10980764|NCT00960011|OG001|Outcome|POLYPROPYLENE|Patient with chronic discomfort at 6 years after operation
10980765|NCT00960011|OG000|Outcome|PROGRIP|pain or discomfort affecting daily activities at 6 years after operation
10980766|NCT00960011|OG001|Outcome|POLYPROPYLENE|pain or discomfort affecting daily activities at 6 years after operation
10980767|NCT00960011|OG000|Outcome|PROGRIP|Total number of analgesic used at 1 week after operation
10980768|NCT00960011|OG001|Outcome|POLYPROPYLENE|Total number of analgesic used at 1 week after operation
10980769|NCT00960011|OG000|Outcome|PROGRIP|wound pain at rest at 1 week after operation
10980770|NCT00960011|OG001|Outcome|POLYPROPYLENE|wound pain at rest at 1 week after operation
10980771|NCT00960011|OG000|Outcome|PROGRIP|wound pain on coughing at 1 week after operation
10980772|NCT00960011|OG001|Outcome|POLYPROPYLENE|wound pain on coughing at 1 week after operation
10980773|NCT00960011|OG000|Outcome|PROGRIP|Post-operative stay (number of hours)
10980774|NCT00960011|OG001|Outcome|POLYPROPYLENE|Post-operative stay (number of hours)
10980775|NCT00960011|OG000|Outcome|PROGRIP|Days go outdoor
10980776|NCT00960011|OG001|Outcome|POLYPROPYLENE|Days go outdoor
10980777|NCT00960011|OG000|Outcome|PROGRIP|satisfy with operation
10980778|NCT00960011|OG001|Outcome|POLYPROPYLENE|satisfy with operation
10980779|NCT00960011|OG000|Outcome|PROGRIP|size of mesh (longitudinal)
10980780|NCT00960011|OG001|Outcome|POLYPROPYLENE|size of mesh (longitudinal)
10980781|NCT00960011|OG000|Outcome|PROGRIP|size of mesh (vertical)
10980782|NCT00960011|OG001|Outcome|POLYPROPYLENE|size of mesh (vertical)
10980783|NCT00960011|OG000|Outcome|PROGRIP|Size of skin wound using PROGRIP mesh for repair (in cm)
10980784|NCT00960011|OG001|Outcome|POLYPROPYLENE|Size of skin wound using polypropylene mesh for repair (in cm)
10980785|NCT00960011|EG000|Reported Event|PROGRIP|"Use of PROGRIP mesh for open inguinal hernia repair~PROGRIP: Use of PROGRIP mesh for open inguinal hernia repair"
10980786|NCT00960011|EG001|Reported Event|POLYPROPYLENE|"Use of Polypropylene mesh for open inguinal hernia repair~POLYPROPYLENE: Use of Polypropylene mesh in open inguinal hernia repair"
10980787|NCT00960063|BG000|Baseline|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980788|NCT00960063|BG001|Baseline|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980789|NCT00960063|BG002|Baseline|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980790|NCT00960063|BG003|Baseline|Total|Total of all reporting groups
10980791|NCT00960063|FG000|Participant Flow|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980792|NCT00960063|FG001|Participant Flow|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980793|NCT00960063|FG002|Participant Flow|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980794|NCT00960063|OG000|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980795|NCT00960063|OG001|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980796|NCT00960063|OG002|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980797|NCT00960063|EG000|Reported Event|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980798|NCT00960063|EG001|Reported Event|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980799|NCT00960063|EG002|Reported Event|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
10980800|NCT00960076|BG000|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
10980801|NCT00960076|BG001|Baseline|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
10980802|NCT00960076|BG002|Baseline|Total|Total of all reporting groups
10980803|NCT00960076|FG000|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
10980804|NCT00960076|FG001|Participant Flow|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
10980805|NCT00960076|OG000|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
10980806|NCT00960076|OG001|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
10980807|NCT00960076|EG000|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
10980808|NCT00960076|EG001|Reported Event|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
10980809|NCT00960115|BG000|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
10980810|NCT00960115|BG001|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
10980811|NCT00960115|BG002|Baseline|Total|Total of all reporting groups
10980812|NCT00960115|FG000|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented.
10980813|NCT00960115|FG001|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
10980814|NCT00960115|OG000|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
10980815|NCT00960115|OG001|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
10980816|NCT00960115|EG000|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
10980817|NCT00960115|EG001|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
10980818|NCT00960193|BG000|Baseline|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
10980819|NCT00960193|FG000|Participant Flow|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
10980820|NCT00960193|OG000|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
10980821|NCT00960193|OG001|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
10980822|NCT00960193|EG000|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at after an overnight fast, followed by a washout period of 14 days.
10980823|NCT00960193|EG001|Reported Event|Seville Orange Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening.
10980824|NCT00960193|EG002|Reported Event|Colchicine With Seville Orange Juice|On Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
10980825|NCT00960206|BG000|Baseline|Trident System|Trident Ceramic Insert/Trident AD with PureFix HA Shell
10980826|NCT00960206|BG001|Baseline|ABC System|Howmedica Osteonics Alumina Insert/either PSL Microstructured or Secur Fit HA PSL Shell
10980827|NCT00960206|BG002|Baseline|Control|Howmedica Osteonics Omnifit Series II Cup Inserts/Omnifit PSL Microstructured Shell
10980828|NCT00960206|BG003|Baseline|Total|Total of all reporting groups
10873752|NCT00429299|OG000|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
10873753|NCT00429299|OG001|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
10873754|NCT00429299|OG002|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
10873755|NCT00429299|EG000|Reported Event|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
10873756|NCT00429299|EG001|Reported Event|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
10873757|NCT00429299|EG002|Reported Event|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
10873758|NCT00429364|BG000|Baseline|Atenolol|Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
10873759|NCT00429364|BG001|Baseline|Losartan|Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
10873760|NCT00429364|BG002|Baseline|Total|Total of all reporting groups
10873761|NCT00429364|FG000|Participant Flow|Atenolol|Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
10873762|NCT00429364|FG001|Participant Flow|Losartan|Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
10873763|NCT00429364|OG000|Outcome|Atenolol|Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
10873764|NCT00429364|OG001|Outcome|Losartan|Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
10873765|NCT00429364|EG000|Reported Event|Atenolol|Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
10873766|NCT00429364|EG001|Reported Event|Losartan|Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
10873767|NCT00429403|BG000|Baseline|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
10873768|NCT00429403|BG001|Baseline|No Goserelin|
10873769|NCT00429403|BG002|Baseline|Total|Total of all reporting groups
10873770|NCT00429403|FG000|Participant Flow|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
10873771|NCT00429403|FG001|Participant Flow|No Goserelin|
10873772|NCT00429403|OG000|Outcome|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
10873773|NCT00429403|OG001|Outcome|No Goserelin|
10980829|NCT00960206|FG000|Participant Flow|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
10980830|NCT00960206|FG001|Participant Flow|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
10980831|NCT00960206|FG002|Participant Flow|Control|Hip received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
10980832|NCT00960206|OG000|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
10980833|NCT00960206|OG001|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
10980834|NCT00960206|OG002|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
10980835|NCT00960206|EG000|Reported Event|Trident® System|Hips that received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
10980836|NCT00960206|EG001|Reported Event|ABC System|Hips that received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
10980837|NCT00960206|EG002|Reported Event|Control|Hips that received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
10980838|NCT00960206|EG003|Reported Event|All Participants|All participants combined.
10980839|NCT00960323|BG000|Baseline|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
10980840|NCT00960323|FG000|Participant Flow|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
10980841|NCT00960323|OG000|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast followed by a 14 day washout period.
10980842|NCT00960323|OG001|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
10980843|NCT00960323|OG000|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
10980844|NCT00960323|EG000|Reported Event|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
10980845|NCT00960323|EG001|Reported Event|Atorvastatin Alone|On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast.
10980846|NCT00960323|EG002|Reported Event|Colchicine and Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
10980847|NCT00960375|BG000|Baseline|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
10980848|NCT00960375|BG001|Baseline|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
10980849|NCT00960375|BG002|Baseline|Total|Total of all reporting groups
10980850|NCT00960375|FG000|Participant Flow|BTSCS|BTSCS includes two 60-minute groups/week (24 total). It is delivered in groups of 4-8 participants run by a trained interventionist. It includes: (1) individual motivational enhancement session to help participants think about personal reasons for change; (2) Breath CO monitoring and goal-setting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about negative health effects of smoking; (5) Relapse prevention; (6) Education about and assistance with nicotine replacement therapy.
10980851|NCT00960375|FG001|Participant Flow|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
11098971|NCT01579084|FG002|Participant Flow|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
10980852|NCT00960375|OG000|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
10980853|NCT00960375|OG001|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
10980854|NCT00960375|EG000|Reported Event|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
10980855|NCT00960375|EG001|Reported Event|StSST|The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups provide education about smoking and support for quitting. Smoking education groups involve weekly (24 groups total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
10980856|NCT00960440|BG000|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
10980857|NCT00960440|BG001|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
10980858|NCT00960440|BG002|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
10980859|NCT00960440|BG003|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
10980860|NCT00960440|BG004|Baseline|Total|Total of all reporting groups
10980861|NCT00960440|FG000|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
10980862|NCT00960440|FG001|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
10980863|NCT00960440|FG002|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
10980864|NCT00960440|FG003|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
10980865|NCT00960440|OG000|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
10980866|NCT00960440|OG001|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
10980867|NCT00960440|OG002|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
10980868|NCT00960440|OG002|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
10980869|NCT00960440|OG003|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
10980870|NCT00960440|EG000|Reported Event|CP-690,550 5 mg Up to Month 3|CP-690,550 5 mg tablet orally twice daily up to Month 3.
10980871|NCT00960440|EG001|Reported Event|CP-690,550 10 mg Up to Month 3|CP-690,550 10 mg tablets orally twice daily up to Month 3.
10980872|NCT00960440|EG002|Reported Event|Placebo Up to Month 3|Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
10980873|NCT00960440|EG003|Reported Event|CP-690,550 5 mg From Month 3 to 6|CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
10980874|NCT00960440|EG004|Reported Event|CP-690,550 10 mg From Month 3 to 6|CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.
10980875|NCT00960505|BG000|Baseline|Alternate Day Fasting (ADF)|"Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)~Alternate day fasting"
10980876|NCT00960505|BG001|Baseline|Calorie Restriction (CR)|"75% energy intake every day~Calorie restriction"
10980877|NCT00960505|BG002|Baseline|Control|"Usual diet~Control diet"
10980878|NCT00960505|BG003|Baseline|Total|Total of all reporting groups
10980879|NCT00960505|FG000|Participant Flow|Alternate Day Fasting (ADF)|"Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)~Alternate day fasting"
10980880|NCT00960505|FG001|Participant Flow|Calorie Restriction (CR)|"75% energy intake every day~Calorie restriction"
10980881|NCT00960505|FG002|Participant Flow|Control|"Usual diet~Control diet"
10980882|NCT00960505|OG000|Outcome|Alternate Day Fasting (ADF)|"Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)~Alternate day fasting"
10980883|NCT00960505|OG001|Outcome|Calorie Restriction (CR)|"75% energy intake every day~Calorie restriction"
10980884|NCT00960505|OG002|Outcome|Control|Usual diet
10980885|NCT00960505|EG000|Reported Event|Alternate Day Fasting (ADF)|"Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)~Alternate day fasting"
10980886|NCT00960505|EG001|Reported Event|Calorie Restriction (CR)|"75% energy intake every day~Calorie restriction"
10980887|NCT00960505|EG002|Reported Event|Control|"Usual diet~Control diet"
10980888|NCT00960531|BG000|Baseline|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980889|NCT00960531|BG001|Baseline|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980890|NCT00960531|BG002|Baseline|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980891|NCT00960531|BG003|Baseline|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980892|NCT00960531|BG004|Baseline|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980893|NCT00960531|BG005|Baseline|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980894|NCT00960531|BG006|Baseline|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980895|NCT00960531|BG007|Baseline|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980896|NCT00960531|BG008|Baseline|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980897|NCT00960531|BG009|Baseline|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980898|NCT00960531|BG010|Baseline|Total|Total of all reporting groups
10980899|NCT00960531|FG000|Participant Flow|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980900|NCT00960531|FG001|Participant Flow|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980901|NCT00960531|FG002|Participant Flow|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980902|NCT00960531|FG003|Participant Flow|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980903|NCT00960531|FG004|Participant Flow|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980904|NCT00960531|FG005|Participant Flow|PBS / ACC 10 µg+QS-21|Participants received Phosphate buffered Saline (PBS) in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980905|NCT00960531|FG006|Participant Flow|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980906|NCT00960531|FG007|Participant Flow|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980907|NCT00960531|FG008|Participant Flow|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10873774|NCT00429403|EG000|Reported Event|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
10873775|NCT00429403|EG001|Reported Event|No Goserelin|
10873776|NCT00429416|BG000|Baseline|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
10873777|NCT00429416|FG000|Participant Flow|LLME to Decrease GVHD Following HSC T|"To determine if an experimental agent, L-leucyl-L-leucine Methyl Ester (LLME), can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).~Treatment Outline:~Day -6: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV Day -5: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -4: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -3: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -2: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -1: Rest day Day 0: CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells Day 1: Infusion of LLME treated donor CD34 - cells"
10873778|NCT00429416|OG000|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
10873779|NCT00429416|EG000|Reported Event|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
10873780|NCT00429494|BG000|Baseline|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
10873781|NCT00429494|FG000|Participant Flow|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
10873782|NCT00429494|OG000|Outcome|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
10873783|NCT00429494|EG000|Reported Event|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
10873784|NCT00429507|BG000|Baseline|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
10873785|NCT00429507|FG000|Participant Flow|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
10873786|NCT00429507|OG000|Outcome|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
10873787|NCT00429507|EG000|Reported Event|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
10873788|NCT00429572|BG000|Baseline|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
10873789|NCT00429572|FG000|Participant Flow|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
10873790|NCT00429572|OG000|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
10873791|NCT00429572|EG000|Reported Event|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
10873792|NCT00429585|BG000|Baseline|Randomized Treatment - Nail|"Randomized Treatment - Nail~reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail"
10873793|NCT00429585|BG001|Baseline|Randomized Treatment - Plate|"Randomized Treatment - Plate~locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate"
10873794|NCT00429585|BG002|Baseline|Total|Total of all reporting groups
10873795|NCT00429585|FG000|Participant Flow|Randomized Treatment - Nail|"Randomized Treatment - Nail~reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail"
10873796|NCT00429585|FG001|Participant Flow|Randomized Treatment - Plate|"Randomized Treatment - Plate~locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate"
10873797|NCT00429585|OG000|Outcome|Randomized Treatment - Nail|"Randomized Treatment - Nail~reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail"
10873798|NCT00429585|OG001|Outcome|Randomized Treatment - Plate|"Randomized Treatment - Plate~locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate"
10873799|NCT00429585|EG000|Reported Event|Randomized Treatment - Nail|"Randomized Treatment - Nail~reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail"
10873800|NCT00429585|EG001|Reported Event|Randomized Treatment - Plate|"Randomized Treatment - Plate~locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate"
10873801|NCT00429663|BG000|Baseline|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
10873802|NCT00429663|BG001|Baseline|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
10873803|NCT00429663|BG002|Baseline|Total|Total of all reporting groups
10873804|NCT00429663|FG000|Participant Flow|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
10873805|NCT00429663|FG001|Participant Flow|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
10873806|NCT00429663|OG000|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
10873807|NCT00429663|OG001|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
10873808|NCT00429663|EG000|Reported Event|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
10873809|NCT00429663|EG001|Reported Event|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
10873810|NCT00429702|BG000|Baseline|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
10873811|NCT00429702|BG001|Baseline|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
10873812|NCT00429702|BG002|Baseline|Total|Total of all reporting groups
10873813|NCT00429702|FG000|Participant Flow|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
10873814|NCT00429702|FG001|Participant Flow|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
10873815|NCT00429702|OG000|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
10873816|NCT00429702|OG001|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
10873817|NCT00429702|EG000|Reported Event|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
10873818|NCT00429702|EG001|Reported Event|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
10873819|NCT00429793|BG000|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10873820|NCT00429793|FG000|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10873821|NCT00429793|OG000|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10873822|NCT00429793|OG000|Outcome|Grade 1 (CTCAE v3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10873823|NCT00429793|OG001|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10873824|NCT00429793|OG002|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10873825|NCT00429793|OG003|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10873826|NCT00429793|OG004|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10873827|NCT00429793|EG000|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10873828|NCT00429949|BG000|Baseline|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
10873829|NCT00429949|FG000|Participant Flow|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
10873830|NCT00429949|OG000|Outcome|Dasatinib 70 mg BID|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
10873831|NCT00429949|OG001|Outcome|Dasatinib 100 mg BID|In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
10873832|NCT00429949|OG000|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
10873833|NCT00429949|EG000|Reported Event|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
10980908|NCT00960531|FG009|Participant Flow|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980909|NCT00960531|OG000|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980910|NCT00960531|OG001|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980911|NCT00960531|OG002|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980912|NCT00960531|OG003|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980913|NCT00960531|OG004|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980914|NCT00960531|OG005|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980915|NCT00960531|OG006|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980916|NCT00960531|OG007|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980917|NCT00960531|OG008|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980918|NCT00960531|OG009|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980919|NCT00960531|OG002|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980920|NCT00960531|OG002|Outcome|Active / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980921|NCT00960531|OG003|Outcome|Control / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980922|NCT00960531|OG004|Outcome|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980923|NCT00960531|OG005|Outcome|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980924|NCT00960531|OG006|Outcome|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980925|NCT00960531|OG007|Outcome|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980926|NCT00960531|OG008|Outcome|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980927|NCT00960531|EG000|Reported Event|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980928|NCT00960531|EG001|Reported Event|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980929|NCT00960531|EG002|Reported Event|Active / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980930|NCT00960531|EG003|Reported Event|Control / ACC 10µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980931|NCT00960531|EG004|Reported Event|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980932|NCT00960531|EG005|Reported Event|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
10980933|NCT00960570|BG000|Baseline|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
10980934|NCT00960570|FG000|Participant Flow|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
10980935|NCT00960570|OG000|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
10980936|NCT00960570|OG001|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
10980937|NCT00960570|EG000|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
10980938|NCT00960570|EG001|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
10980939|NCT00960570|EG002|Reported Event|Efavirenz and Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
10980940|NCT00960622|BG000|Baseline|Truvada|switch from Combivir to Truvada
10980941|NCT00960622|BG001|Baseline|Combivir, Trizivir.|continue on Combivir, trizivir.
10980942|NCT00960622|BG002|Baseline|Total|Total of all reporting groups
10980943|NCT00960622|FG000|Participant Flow|Truvada 200/300 mg, Daily, by Mouth.|The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada.
10980944|NCT00960622|FG001|Participant Flow|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.
10980945|NCT00960622|OG000|Outcome|Truvada 200/300 mg, Daily, by Mouth.|switch from Combivir or trizivir to Truvada 200/300 mg, daily, by mouth.
10980946|NCT00960622|OG001|Outcome|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|continue on Combivir 150/300 mg, or trizivir 300/150/300 mg daily.
10980947|NCT00960622|EG000|Reported Event|Truvada|switch from Combivir to Truvada
10980948|NCT00960622|EG001|Reported Event|Combivir, Trizivir.|continue on Combivir, trizivir.
10980949|NCT00960661|BG000|Baseline|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
10980950|NCT00960661|BG001|Baseline|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
10980951|NCT00960661|BG002|Baseline|Total|Total of all reporting groups
10980952|NCT00960661|FG000|Participant Flow|Enrolled|Patients who enrolled in the basal insulin optimization (BIO) phase
10980953|NCT00960661|FG001|Participant Flow|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
10980954|NCT00960661|FG002|Participant Flow|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
10980955|NCT00960661|OG000|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
10980956|NCT00960661|OG001|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
10980957|NCT00960661|EG000|Reported Event|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
10980958|NCT00960661|EG001|Reported Event|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
10980959|NCT00960687|BG000|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg, 30 minutes after the initiation of a standard meal.
10980960|NCT00960687|FG000|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast.
10980961|NCT00960687|FG001|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast.
10980962|NCT00960687|OG000|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
10980963|NCT00960687|OG001|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
10980964|NCT00960687|EG000|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg 30 minutes after the initiation of a standard breakfast.
10980965|NCT00960687|EG001|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg 30 minutes after the initiation of a standard breakfast.
10980966|NCT00960778|BG000|Baseline|Nicotine- Dependent Women|Over a period of one week, nicotine-dependent women completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
10873834|NCT00430183|BG000|Baseline|Arm A: Docetaxel + LHRH Agonist + Surgical Intervention|"Patients receive six cycles of 75 mg/m^2 docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines.> > Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. >~> Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery."
10873835|NCT00430183|BG001|Baseline|Arm B: Surgical Intervention|All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
10873836|NCT00430183|BG002|Baseline|Total|Total of all reporting groups
10873837|NCT00430183|FG000|Participant Flow|Arm A: Docetaxel + LHRH Agonist + Surgical Intervention|Patients receive six cycles of 75 mg/m^2 docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines.Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
10873838|NCT00430183|FG001|Participant Flow|Arm B: Surgical Intervention|All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery(surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
10873839|NCT00430183|OG000|Outcome|Arm A: Docetaxel + LHRH Agonist + Surgical Intervention|"Patients receive six cycles of 75 mg/m^2 docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines.> > Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. >~> Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery."
10873840|NCT00430183|OG001|Outcome|Arm B: Surgical Intervention|All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
10873841|NCT00430183|EG000|Reported Event|Arm A: Docetaxel + LHRH Agonist + Surgical Intervention|Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
10873842|NCT00430183|EG001|Reported Event|Arm B: Surgical Intervention|All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
10873843|NCT00430248|BG000|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
10873844|NCT00430248|BG001|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
10873845|NCT00430248|BG002|Baseline|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
10873846|NCT00430248|BG003|Baseline|Total|Total of all reporting groups
10873847|NCT00430248|FG000|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
10873848|NCT00430248|FG001|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
10873849|NCT00430248|FG002|Participant Flow|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
10873850|NCT00430248|OG000|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
10873851|NCT00430248|OG001|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
10873852|NCT00430248|OG002|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
10873853|NCT00430248|EG000|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
10873854|NCT00430248|EG001|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
10873855|NCT00430248|EG002|Reported Event|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
10873856|NCT00430300|BG000|Baseline|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873857|NCT00430300|BG001|Baseline|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873858|NCT00430300|BG002|Baseline|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873859|NCT00430300|BG003|Baseline|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873860|NCT00430300|BG004|Baseline|Total|Total of all reporting groups
10873861|NCT00430300|FG000|Participant Flow|UK-432,097 150 Mcg|UK-432,097 150 microgram (mcg) capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide metered dose inhaler (MDI) 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873862|NCT00430300|FG001|Participant Flow|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873863|NCT00430300|FG002|Participant Flow|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873864|NCT00430300|FG003|Participant Flow|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873865|NCT00430300|OG000|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873866|NCT00430300|OG001|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873867|NCT00430300|OG002|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873868|NCT00430300|OG003|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873869|NCT00430300|EG000|Reported Event|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873870|NCT00430300|EG001|Reported Event|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873871|NCT00430300|EG002|Reported Event|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10980967|NCT00960778|BG001|Baseline|Nicotine- Dependent Men|Over a period of one week, nicotine-dependent men completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
10980968|NCT00960778|BG002|Baseline|Total|Total of all reporting groups
10980969|NCT00960778|FG000|Participant Flow|Nicotine- Dependent Women|Over a period of one week, nicotine-dependent women completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
10980970|NCT00960778|FG001|Participant Flow|Nicotine- Dependent Men|Over a period of one week, nicotine-dependent men completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
10980971|NCT00960778|OG000|Outcome|Nicotine- Dependent Women|Over a period of one week, nicotine-dependent women completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
10980972|NCT00960778|OG001|Outcome|Nicotine- Dependent Men|Over a period of one week, nicotine-dependent men completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
10980973|NCT00960778|EG000|Reported Event|Nicotine- Dependent Women|Over a period of one week, nicotine-dependent women completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
10980974|NCT00960778|EG001|Reported Event|Nicotine- Dependent Men|Over a period of one week, nicotine-dependent men completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
10980975|NCT00960804|BG000|Baseline|Tanezumab 5 mg + Standard of Care|Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.
10980976|NCT00960804|BG001|Baseline|Tanezumab 10 mg + Standard of Care|Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
10980977|NCT00960804|BG002|Baseline|Placebo + Standard of Care|Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
10980978|NCT00960804|BG003|Baseline|Total|Total of all reporting groups
10980979|NCT00960804|FG000|Participant Flow|Tanezumab 5 mg + Standard of Care|Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.
10980980|NCT00960804|FG001|Participant Flow|Tanezumab 10 mg + Standard of Care|Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
10980981|NCT00960804|FG002|Participant Flow|Placebo + Standard of Care|Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
10980982|NCT00960804|OG000|Outcome|Tanezumab 5 mg + Standard of Care|Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.
10980983|NCT00960804|OG001|Outcome|Tanezumab 10 mg + Standard of Care|Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
10873872|NCT00430300|EG003|Reported Event|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
10873873|NCT00430352|BG000|Baseline|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
10873874|NCT00430352|FG000|Participant Flow|Rituximab 375 Milligrams Per Square Meter (mg/m^2)|Participants received rituximab 375 mg/m^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.
10873875|NCT00430352|OG000|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
10873876|NCT00430352|EG000|Reported Event|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
10873877|NCT00430482|BG000|Baseline|Cognitive Behavior Therapy|Psychosocial treatment with an individualized therapy emphasizing interoceptive exposure and training alternative responses to cues for drug use
10873878|NCT00430482|BG001|Baseline|Individual Drug Counseling|Psychosocial treatment with individual drug counseling
10873879|NCT00430482|BG002|Baseline|Total|Total of all reporting groups
10873880|NCT00430482|FG000|Participant Flow|Cognitive Behavioral Therapy|"Cognitive Behavioral Therapy~Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy"
10873881|NCT00430482|FG001|Participant Flow|Individual Drug Counseling|"Individual Drug Counseling~Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling"
10873882|NCT00430482|OG000|Outcome|Cognitive Behavioral Therapy|"Cognitive Behavioral Therapy~Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy"
10873883|NCT00430482|OG001|Outcome|Individual Drug Counseling|"Individual Drug Counseling~Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling"
10873884|NCT00430482|EG000|Reported Event|Cognitive Behavioral Therapy|"Cognitive Behavioral Therapy~Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy"
10873885|NCT00430482|EG001|Reported Event|Individual Drug Counseling|"Individual Drug Counseling~Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling"
10873886|NCT00430495|BG000|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
10873887|NCT00430495|BG001|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
10873888|NCT00430495|BG002|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
10873889|NCT00430495|BG003|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
10873890|NCT00430495|BG004|Baseline|Total|Total of all reporting groups
10873891|NCT00430495|FG000|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
10873892|NCT00430495|FG001|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
10873893|NCT00430495|FG002|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
10873894|NCT00430495|FG003|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
10873895|NCT00430495|OG000|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
10873896|NCT00430495|OG001|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
10873897|NCT00430495|OG002|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
10873898|NCT00430495|OG003|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
10873899|NCT00430495|EG000|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
10873900|NCT00430495|EG001|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
10873901|NCT00430495|EG002|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
10873902|NCT00430495|EG003|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
10873903|NCT00430521|BG000|Baseline|GSK1562902A V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
11098972|NCT01579084|FG003|Participant Flow|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10873904|NCT00430521|BG001|Baseline|GSK1562902A V/V/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873905|NCT00430521|BG002|Baseline|GSK1562902A 2V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.
10873906|NCT00430521|BG003|Baseline|GSK1562902A 2V/V/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873907|NCT00430521|BG004|Baseline|GSK1562902A V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873908|NCT00430521|BG005|Baseline|GSK1562902A V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873909|NCT00430521|BG006|Baseline|GSK1562902A 2V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
10873910|NCT00430521|BG007|Baseline|GSK1562902A 2V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873911|NCT00430521|BG008|Baseline|Total|Total of all reporting groups
10873912|NCT00430521|FG000|Participant Flow|GSK1562902A V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873913|NCT00430521|FG001|Participant Flow|GSK1562902A V/V/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873914|NCT00430521|FG002|Participant Flow|GSK1562902A 2V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.
10873915|NCT00430521|FG003|Participant Flow|GSK1562902A 2V/V/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873916|NCT00430521|FG004|Participant Flow|GSK1562902A V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873917|NCT00430521|FG005|Participant Flow|GSK1562902A V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873918|NCT00430521|FG006|Participant Flow|GSK1562902A 2V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
10873919|NCT00430521|FG007|Participant Flow|GSK1562902A 2V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
10873920|NCT00430521|OG000|Outcome|GSK1562902A V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873921|NCT00430521|OG001|Outcome|GSK1562902A V/V/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873922|NCT00430521|OG002|Outcome|GSK1562902A 2V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873923|NCT00430521|OG003|Outcome|GSK1562902A 2V/V/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10980984|NCT00960804|OG002|Outcome|Placebo + Standard of Care|Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
10980985|NCT00960804|EG000|Reported Event|Tanezumab 5 mg + Standard of Care|Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.
10980986|NCT00960804|EG001|Reported Event|Tanezumab 10 mg + Standard of Care|Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
10980987|NCT00960804|EG002|Reported Event|Placebo + Standard of Care|Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
10980988|NCT00960843|BG000|Baseline|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
10980989|NCT00960843|BG001|Baseline|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
10980990|NCT00960843|BG002|Baseline|Total|Total of all reporting groups
10980991|NCT00960843|FG000|Participant Flow|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
10980992|NCT00960843|FG001|Participant Flow|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
10980993|NCT00960843|OG000|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
10980994|NCT00960843|OG001|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
10980995|NCT00960843|EG000|Reported Event|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
10980996|NCT00960843|EG001|Reported Event|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
10980997|NCT00960856|BG000|Baseline|Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted|All subjects received each of the four study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8, 15 and 22 each subject received one tablet of fenofibric acid 105 mg administered after one of the following meal conditions: 1) low-fat meal, 2) standard meal, 3) high-fat/high-calorie meal 4) overnight fast of at least 10 hours.
10980998|NCT00960856|FG000|Participant Flow|Sequence ABCD|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
10980999|NCT00960856|FG001|Participant Flow|Sequence BCDA|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
10981000|NCT00960856|FG002|Participant Flow|Sequence CDAB|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
10981001|NCT00960856|FG003|Participant Flow|Sequence DABC|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
10981002|NCT00960856|OG000|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
10981003|NCT00960856|OG001|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
10981004|NCT00960856|OG002|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
10981005|NCT00960856|OG003|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
10981006|NCT00960856|EG000|Reported Event|Low-Fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
10981007|NCT00960856|EG001|Reported Event|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
10981008|NCT00960856|EG002|Reported Event|High-fat, High-calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
10981009|NCT00960856|EG003|Reported Event|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid following an overnight fast of at least 10 hours.
10981010|NCT00960869|BG000|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
10981011|NCT00960869|BG001|Baseline|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
10981012|NCT00960869|BG002|Baseline|Total|Total of all reporting groups
10981013|NCT00960869|FG000|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
10981014|NCT00960869|FG001|Participant Flow|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
10981015|NCT00960869|OG000|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
10981016|NCT00960869|OG001|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
10981017|NCT00960869|EG000|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
10981018|NCT00960869|EG001|Reported Event|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
10981019|NCT00960934|BG000|Baseline|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
10981020|NCT00960934|BG001|Baseline|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
10981021|NCT00960934|BG002|Baseline|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
10981022|NCT00960934|BG003|Baseline|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
10981023|NCT00960934|BG004|Baseline|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
10981024|NCT00960934|BG005|Baseline|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
10981025|NCT00960934|BG006|Baseline|Total|Total of all reporting groups
10981026|NCT00960934|FG000|Participant Flow|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
10981027|NCT00960934|FG001|Participant Flow|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
10981028|NCT00960934|FG002|Participant Flow|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
10981029|NCT00960934|FG003|Participant Flow|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
10981030|NCT00960934|FG004|Participant Flow|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
10981031|NCT00960934|FG005|Participant Flow|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
10981032|NCT00960934|OG000|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
10981033|NCT00960934|OG001|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
10981034|NCT00960934|OG002|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
10981035|NCT00960934|OG003|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
10981036|NCT00960934|OG004|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
10981037|NCT00960934|OG005|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
10981038|NCT00960934|EG000|Reported Event|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
10981039|NCT00960934|EG001|Reported Event|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
10981040|NCT00960934|EG002|Reported Event|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
10981041|NCT00960934|EG003|Reported Event|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
10981042|NCT00960934|EG004|Reported Event|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
10981043|NCT00960934|EG005|Reported Event|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
10981044|NCT00960986|BG000|Baseline|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
10981045|NCT00960986|BG001|Baseline|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
10981046|NCT00960986|BG002|Baseline|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
10981047|NCT00960986|BG003|Baseline|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
10981048|NCT00960986|BG004|Baseline|Total|Total of all reporting groups
10981049|NCT00960986|FG000|Participant Flow|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
10981050|NCT00960986|FG001|Participant Flow|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
10981051|NCT00960986|FG002|Participant Flow|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
10981052|NCT00960986|FG003|Participant Flow|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
10981053|NCT00960986|OG000|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
10981054|NCT00960986|OG001|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
10981055|NCT00960986|OG002|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
10981056|NCT00960986|OG003|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
10981057|NCT00960986|EG000|Reported Event|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
10981058|NCT00960986|EG001|Reported Event|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
10981059|NCT00960986|EG002|Reported Event|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
10981060|NCT00960986|EG003|Reported Event|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
10981061|NCT00960999|BG000|Baseline|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
10981062|NCT00960999|BG001|Baseline|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
10981063|NCT00960999|BG002|Baseline|Total|Total of all reporting groups
10981064|NCT00960999|FG000|Participant Flow|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
10981065|NCT00960999|FG001|Participant Flow|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
10981066|NCT00960999|OG000|Outcome|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
10981067|NCT00960999|OG001|Outcome|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
10981068|NCT00960999|EG000|Reported Event|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
10981069|NCT00960999|EG001|Reported Event|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
10981070|NCT00961051|BG000|Baseline|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
10981071|NCT00961051|BG001|Baseline|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
10981072|NCT00961051|BG002|Baseline|Total|Total of all reporting groups
10981073|NCT00961051|FG000|Participant Flow|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
10981074|NCT00961051|FG001|Participant Flow|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
10981075|NCT00961051|OG000|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
10981076|NCT00961051|OG001|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
10981077|NCT00961051|EG000|Reported Event|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
10981078|NCT00961051|EG001|Reported Event|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
10981079|NCT00961116|BG000|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg following an overnight fast.
10981080|NCT00961116|FG000|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, after an overnight fast.
10981081|NCT00961116|FG001|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference, fenofibrate 145 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, after an overnight fast.
10981082|NCT00961116|OG000|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
10981083|NCT00961116|OG001|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
10981084|NCT00961116|OG001|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
10981085|NCT00961116|EG000|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg after an overnight fast of at least 10 hours.
10981086|NCT00961116|EG001|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
10981087|NCT00961181|BG000|Baseline|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
10981088|NCT00961181|FG000|Participant Flow|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
10981089|NCT00961181|OG000|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
10981090|NCT00961181|EG000|Reported Event|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
11098973|NCT01579084|FG004|Participant Flow|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10981091|NCT00961220|BG000|Baseline|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
10981092|NCT00961220|FG000|Participant Flow|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
10981093|NCT00961220|OG000|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV~carmustine: Applied topically~laboratory biomarker analysis: Correlative studies"
10981094|NCT00961220|OG000|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
10981095|NCT00961220|OG000|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
10981096|NCT00961220|EG000|Reported Event|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
10981097|NCT00961233|BG000|Baseline|Inhaled/Swallowed Budesonide|
10981098|NCT00961233|BG001|Baseline|Viscous/Swallowed Budesonide|
10981099|NCT00961233|BG002|Baseline|Total|Total of all reporting groups
10981100|NCT00961233|FG000|Participant Flow|Inhaled/Swallowed Budesonide|inhaled/swallowed budesonide - nebulized budesonide 1mg twice daily that is swallowed.
10981101|NCT00961233|FG001|Participant Flow|Viscous/Swallowed Budesonide|viscous/swallowed budesonide - budesonide slurry (created with 5g sucralose) 1 mg twice daily that is swallowed
10981102|NCT00961233|OG000|Outcome|Inhaled/Swallowed Budesonide|
10981103|NCT00961233|OG001|Outcome|Viscous/Swallowed Budesonide|
10981104|NCT00961233|OG000|Outcome|Inhaled/Swallowed Budesonide|nebulized then swallowed budesonide 1mg twice daily
10981105|NCT00961233|OG001|Outcome|Viscous/Swallowed Budesonide|viscous slurry of budesonide and sucralose 1 mg twice daily
10981106|NCT00961233|EG000|Reported Event|Inhaled/Swallowed Budesonide|
10981107|NCT00961233|EG001|Reported Event|Viscous/Swallowed Budesonide|
10981108|NCT00961259|BG000|Baseline|Fenofibric Acid - Treatments A, B and C|All subjects received each of the three study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8 and 15 each subject received either one 35 mg fenofibric acid tablet (treatment A), three 35 mg fenofibric acid tablets (105 mg total dose, treatment B) or one 105 mg fenofibric acid tablet (treatment C).
10981109|NCT00961259|FG000|Participant Flow|Treatment Sequence ABC|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).
10981110|NCT00961259|FG001|Participant Flow|Treatment Sequence BCA|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).
10981111|NCT00961259|FG002|Participant Flow|Treatment Sequence CAB|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).
10981112|NCT00961259|OG000|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
10981113|NCT00961259|OG001|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
10981114|NCT00961259|OG002|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
10981115|NCT00961259|OG003|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
10981116|NCT00961259|EG000|Reported Event|Fenofibric Acid 35 mg (1 x 35 mg Tablet), Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
10981117|NCT00961259|EG001|Reported Event|Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B|Each subject received three (3) tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
10981118|NCT00961259|EG002|Reported Event|Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
10981119|NCT00961298|BG000|Baseline|Treatment Arm|every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
10981120|NCT00961298|FG000|Participant Flow|Treatment Arm|Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
10981121|NCT00961298|OG000|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
10981122|NCT00961298|EG000|Reported Event|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
10981123|NCT00961311|BG000|Baseline|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
10981124|NCT00961311|FG000|Participant Flow|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
10981125|NCT00961311|OG000|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
10981126|NCT00961311|EG000|Reported Event|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
10981127|NCT00961350|BG000|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
10981128|NCT00961350|BG001|Baseline|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
10981129|NCT00961350|BG002|Baseline|Total|Total of all reporting groups
10981130|NCT00961350|FG000|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
10981131|NCT00961350|FG001|Participant Flow|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
10981132|NCT00961350|OG000|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
10981133|NCT00961350|OG001|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
10981134|NCT00961350|EG000|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
10981135|NCT00961350|EG001|Reported Event|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
10981136|NCT00961402|BG000|Baseline|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
10981137|NCT00961402|BG001|Baseline|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
10981138|NCT00961402|BG002|Baseline|Total|Total of all reporting groups
10981139|NCT00961402|FG000|Participant Flow|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
10981140|NCT00961402|FG001|Participant Flow|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
10981141|NCT00961402|OG000|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
10981142|NCT00961402|OG001|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
10981143|NCT00961402|EG000|Reported Event|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
10981144|NCT00961402|EG001|Reported Event|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
10981145|NCT00961415|BG000|Baseline|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
11098974|NCT01579084|FG005|Participant Flow|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10873924|NCT00430521|OG000|Outcome|GSK1562902A V/I/6 Group|Subjects received 1 dose of vaccine formulated from VT strain at Day 0 and 1 dose of the vaccine including IN at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873925|NCT00430521|OG001|Outcome|GSK1562902A V/V/6 Group|Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873926|NCT00430521|OG002|Outcome|GSK1562902A 2V/I/6 Group|Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.
10873927|NCT00430521|OG003|Outcome|GSK1562902A 2V/V/6 Group|Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873928|NCT00430521|OG004|Outcome|GSK1562902A V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873929|NCT00430521|OG005|Outcome|GSK1562902A V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873930|NCT00430521|OG006|Outcome|GSK1562902A 2V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873931|NCT00430521|OG007|Outcome|GSK1562902A 2V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873932|NCT00430521|OG002|Outcome|GSK1562902A 2V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.
10873933|NCT00430521|OG006|Outcome|GSK1562902A 2V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
10873934|NCT00430521|OG007|Outcome|GSK1562902A 2V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
10873935|NCT00430521|OG000|Outcome|GSK1562902A V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873936|NCT00430521|OG001|Outcome|GSK1562902A V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873937|NCT00430521|OG002|Outcome|GSK1562902A 2V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873938|NCT00430521|OG003|Outcome|GSK1562902A 2V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873939|NCT00430521|OG002|Outcome|GSK1562902A 2V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
10873940|NCT00430521|OG003|Outcome|GSK1562902A 2V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
10873941|NCT00430521|EG000|Reported Event|GSK1562902A V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873942|NCT00430521|EG001|Reported Event|GSK1562902A V/V/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
11098975|NCT01579084|FG006|Participant Flow|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
11098976|NCT01579084|FG007|Participant Flow|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
10873943|NCT00430521|EG002|Reported Event|GSK1562902A 2V/I/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873944|NCT00430521|EG003|Reported Event|GSK1562902A 2V/V/6 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
10873945|NCT00430521|EG004|Reported Event|GSK1562902A V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873946|NCT00430521|EG005|Reported Event|GSK1562902A V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873947|NCT00430521|EG006|Reported Event|GSK1562902A 2V/I/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873948|NCT00430521|EG007|Reported Event|GSK1562902A 2V/V/12 Group|Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
10873949|NCT00430573|BG000|Baseline|Overall Study Characteristics|All participants who consented to be in the study
10873950|NCT00430573|FG000|Participant Flow|All Randomized Participants|The blind was never broken for the study drug, therefore, results can only be presented aggregated for all randomized participants.
10873951|NCT00430573|OG000|Outcome|All Randomized Participants|10 participants were randomized and 5 dropped out before taking study drug. The blind was never broken for the study drug, Therefore, results can only be presented aggregated for all randomized participants.
10873952|NCT00430573|OG000|Outcome|Randomized Participants That Completed Baseline ASI|8 of the 10 randomized participants completed the baseline ASI evaluation.
10873953|NCT00430573|EG000|Reported Event|All Randomized Participants|10 participants were randomized and 5 dropped out before taking study drug. The blind was never broken for the study drug, Therefore, results can only be presented aggregated for all randomized participants.
11098977|NCT01579084|FG008|Participant Flow|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
10873954|NCT00430625|BG000|Baseline|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873955|NCT00430625|BG001|Baseline|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873956|NCT00430625|BG002|Baseline|Total|Total of all reporting groups
10873957|NCT00430625|FG000|Participant Flow|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873958|NCT00430625|FG001|Participant Flow|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873959|NCT00430625|OG000|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873960|NCT00430625|OG000|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873961|NCT00430625|OG001|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873962|NCT00430625|EG000|Reported Event|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873963|NCT00430625|EG001|Reported Event|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
10873964|NCT00430638|BG000|Baseline|Olmesartan Group|Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12).
10873965|NCT00430638|BG001|Baseline|Placebo Group|Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment.
10873966|NCT00430638|BG002|Baseline|Total|Total of all reporting groups
10873967|NCT00430638|FG000|Participant Flow|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
11098978|NCT01579084|FG009|Participant Flow|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
11098979|NCT01579084|OG000|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
11098980|NCT01579084|OG001|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
10873968|NCT00430638|FG001|Participant Flow|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
10873969|NCT00430638|OG000|Outcome|Placebo|Patient received placebo tablets.
10873970|NCT00430638|OG001|Outcome|Olmesartan Group|Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
10873971|NCT00430638|OG000|Outcome|Placebo Group|Patient received placebo tablets throughout the 12-week active treatment period.
10873972|NCT00430638|OG001|Outcome|Olmesartan Group|Participants received olmesartan medoxomil tablets + hydrochlorothiazide tablets, if necessary, once daily for the duration of the 12-week active treatment period.
10873973|NCT00430638|OG000|Outcome|Olmesartan vs. Placebo|
10873974|NCT00430638|OG000|Outcome|Olmesartan vs. Placebo|145 females participants were analyzed.
10873975|NCT00430638|EG000|Reported Event|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
10873976|NCT00430638|EG001|Reported Event|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
10873977|NCT00430677|BG000|Baseline|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873978|NCT00430677|BG001|Baseline|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873979|NCT00430677|BG002|Baseline|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873980|NCT00430677|BG003|Baseline|Total|Total of all reporting groups
10873981|NCT00430677|FG000|Participant Flow|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10873982|NCT00430677|FG001|Participant Flow|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10873983|NCT00430677|FG002|Participant Flow|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10873984|NCT00430677|OG000|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
10873985|NCT00430677|OG001|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873986|NCT00430677|OG002|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873987|NCT00430677|OG000|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873988|NCT00430677|OG001|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycofenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
10873989|NCT00430677|OG002|Outcome|Placebo|Placebo (dextrose 5% in water) or normal saline by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873990|NCT00430677|OG000|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10981146|NCT00961415|BG001|Baseline|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
10981147|NCT00961415|BG002|Baseline|Total|Total of all reporting groups
10981148|NCT00961415|FG000|Participant Flow|Induction Treatment Phase|Bevacizumab 7.5 milligram (mg)/ kilogram (kg) + cisplatin 75 mg/m^2 + pemetrexed 500 mg/m^2 was administered intravenously (IV) every 3 weeks. Participants received 4 cycles of induction therapy.
10981149|NCT00961415|FG001|Participant Flow|Bevacizumab Maintenance Treatment (Trt) Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
10981150|NCT00961415|FG002|Participant Flow|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
10981151|NCT00961415|OG000|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
10981152|NCT00961415|OG001|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
10981153|NCT00961415|OG000|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
10981154|NCT00961415|OG001|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis.
10981155|NCT00961415|OG002|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
10981156|NCT00961415|OG001|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
10981157|NCT00961415|OG002|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm...
10981158|NCT00961415|OG000|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy
10981159|NCT00961415|OG001|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 mcg daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
10981160|NCT00961415|EG000|Reported Event|No Maintenance Treatment|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm..
10981161|NCT00961415|EG001|Reported Event|Maintenance Treatment Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis
10981162|NCT00961415|EG002|Reported Event|Maintenance Treatment Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
10981163|NCT00961441|BG000|Baseline|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
10873991|NCT00430677|OG001|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873992|NCT00430677|OG000|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10873993|NCT00430677|OG000|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
10873994|NCT00430677|OG001|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
10873995|NCT00430677|OG002|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
10873996|NCT00430677|OG000|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
10873997|NCT00430677|OG001|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
10873998|NCT00430677|OG002|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) Short-term period: by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
10873999|NCT00430677|OG000|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10874000|NCT00430677|OG001|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10874001|NCT00430677|OG002|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10874002|NCT00430677|OG000|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10874003|NCT00430677|OG000|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10874004|NCT00430677|OG001|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
10981164|NCT00961441|BG001|Baseline|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
10981165|NCT00961441|BG002|Baseline|Total|Total of all reporting groups
10981166|NCT00961441|FG000|Participant Flow|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
10981167|NCT00961441|FG001|Participant Flow|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
10981168|NCT00961441|OG000|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
10981169|NCT00961441|OG001|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
10981170|NCT00961441|EG000|Reported Event|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
10981171|NCT00961441|EG001|Reported Event|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
10981172|NCT00961532|BG000|Baseline|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
10981173|NCT00961532|FG000|Participant Flow|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
10981174|NCT00961532|OG000|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
10981175|NCT00961532|EG000|Reported Event|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
10981176|NCT00961571|BG000|Baseline|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
10981177|NCT00961571|FG000|Participant Flow|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
10981178|NCT00961571|OG000|Outcome|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
10981179|NCT00961571|EG000|Reported Event|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
11007082|NCT01089413|BG000|Baseline|Bevacizumab: Age <70 Years|Participants aged less than (<) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
11007083|NCT01089413|BG001|Baseline|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
11007084|NCT01089413|BG002|Baseline|Bevacizumab: Age >80 Years|Participants aged greater than (>) 80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
11007085|NCT01089413|BG003|Baseline|Total|Total of all reporting groups
11007086|NCT01089413|FG000|Participant Flow|Bevacizumab: Overall|All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
11007087|NCT01089413|OG000|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
11007088|NCT01089413|OG001|Outcome|Bevacizumab: Age ≥70 Years|"Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups 70-80 Years and >80 Years have been pooled in this group."
11007089|NCT01089413|OG002|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
11007090|NCT01089413|OG000|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
11098981|NCT01579084|OG002|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
10981180|NCT00961636|BG000|Baseline|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
10981181|NCT00961636|BG001|Baseline|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
10981182|NCT00961636|BG002|Baseline|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
10981183|NCT00961636|BG003|Baseline|Total|Total of all reporting groups
10981184|NCT00961636|FG000|Participant Flow|ERN/LRPT|One 1g/20 mg tablet Extended -release niacin (+) laropiprant (ERN/LRPT) once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
10981185|NCT00961636|FG001|Participant Flow|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
10981186|NCT00961636|FG002|Participant Flow|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
10981187|NCT00961636|OG000|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
10981188|NCT00961636|OG001|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
10981189|NCT00961636|OG002|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
10981190|NCT00961636|EG000|Reported Event|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
10981191|NCT00961636|EG001|Reported Event|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
10981192|NCT00961636|EG002|Reported Event|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
10981193|NCT00961649|BG000|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981194|NCT00961649|BG001|Baseline|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981195|NCT00961649|BG002|Baseline|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981196|NCT00961649|BG003|Baseline|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981197|NCT00961649|BG004|Baseline|Total|Total of all reporting groups
10981198|NCT00961649|FG000|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981199|NCT00961649|FG001|Participant Flow|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981200|NCT00961649|FG002|Participant Flow|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981201|NCT00961649|FG003|Participant Flow|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981202|NCT00961649|OG000|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981203|NCT00961649|OG001|Outcome|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981204|NCT00961649|OG002|Outcome|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981205|NCT00961649|OG001|Outcome|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981206|NCT00961649|EG000|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981207|NCT00961649|EG001|Reported Event|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981208|NCT00961649|EG002|Reported Event|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981209|NCT00961649|EG003|Reported Event|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
10981210|NCT00961662|BG000|Baseline|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
10981211|NCT00961662|BG001|Baseline|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
10981212|NCT00961662|BG002|Baseline|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
10981213|NCT00961662|BG003|Baseline|Total|Total of all reporting groups
10981214|NCT00961662|FG000|Participant Flow|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
10981215|NCT00961662|FG001|Participant Flow|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
10981216|NCT00961662|FG002|Participant Flow|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
10981217|NCT00961662|OG000|Outcome|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
10981218|NCT00961662|OG001|Outcome|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
10981219|NCT00961662|OG002|Outcome|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
10981220|NCT00961662|EG000|Reported Event|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
10981221|NCT00961662|EG001|Reported Event|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
10981222|NCT00961662|EG002|Reported Event|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
10981223|NCT00961896|BG000|Baseline|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
10981224|NCT00961896|BG001|Baseline|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
10981225|NCT00961896|BG002|Baseline|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
10981226|NCT00961896|BG003|Baseline|Total|Total of all reporting groups
10981227|NCT00961896|FG000|Participant Flow|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
10981228|NCT00961896|FG001|Participant Flow|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
10981229|NCT00961896|FG002|Participant Flow|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
10981230|NCT00961896|OG000|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
10981231|NCT00961896|OG001|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
10981232|NCT00961896|OG002|Outcome|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
10981233|NCT00961896|OG003|Outcome|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
10981234|NCT00961896|OG000|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
10981235|NCT00961896|OG001|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
10981236|NCT00961896|EG000|Reported Event|All Part I Participants|Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
10981237|NCT00961896|EG001|Reported Event|0.25% LDE225 [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
10981238|NCT00961896|EG002|Reported Event|0.75% LDE225 [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
10981239|NCT00961961|BG000|Baseline|Lithium Plus Fluoxetine Phase I|All eligible and consenting participants began in this open phase. Therefore baseline characteristics are only relevant for this category.
10981240|NCT00961961|BG001|Baseline|Lithium Plus Placebo Phase I|No participant was begun on Placebo. Lithium Plus Placebo was a real condition only after randomization, in Phase II. Baseline characteristics for all participants are listed under Lithium plus Fluoxetine Phase I.
10981241|NCT00961961|BG002|Baseline|Lithium Plus Fluoxetine Phase II|This is a subset of patients whose baseline characteristics are listed under Lithium plus Fluoxetine Phase I.
10981242|NCT00961961|BG003|Baseline|Lithium Plus Placebo Phase II|This is a subset of patients whose baseline characteristics are listed under Lithium plus Fluoxetine Phase I.
10981243|NCT00961961|BG004|Baseline|Total|Total of all reporting groups
10981244|NCT00961961|FG000|Participant Flow|Lithium Plus Fluoxetine Phase I|Lithium / Fluoxetine: Individualized Daily Dosage
10981245|NCT00961961|FG001|Participant Flow|Lithium Plus Placebo Phase I|This is a placeholder arm. No participants were given Placebo in Phase I.
10981246|NCT00961961|FG002|Participant Flow|Lithium Plus Fluoxetine Phase II|One of the two randomly assigned groups, each of which continued on Lithium Double-blind assignment to continue on Fluoxetine (this group)
10981247|NCT00961961|FG003|Participant Flow|Lithium Plus Placebo Phase II|One of the two randomly assigned groups, each of which continued on Lithium Double-blind assignment to switch from Fluoxetine to Placebo (this group)
10981248|NCT00961961|OG000|Outcome|Lithium Plus Fluoxetine Phase I|The outcome measures, including this one, are only relevant in Phase II. Thus there will be zeroes in this category.
10981249|NCT00961961|OG001|Outcome|Lithium Plus Placebo Phase I|The outcome measures, including this one, are only relevant in Phase II. Thus there will be zeroes in this category.
10981250|NCT00961961|OG002|Outcome|Lithium Plus Fluoxetine Phase II|Participants randomized to this condition remained on active medications. However, the fluoxetine pills were made to look like the placebo pills, to maintain the double-blind.
10981251|NCT00961961|OG003|Outcome|Lithium Plus Placebo Phase II|Participants randomized to this condition were switched from fluoxetine to placebo. However, the placebo pills were made to look like the fluoxetine pills, to maintain the double-blind.
10981252|NCT00961961|OG000|Outcome|Lithium Plus Fluoxetine Phase I|This is not a relevant category for this outcome. This outcome is only assessed in Phase II.
10981253|NCT00961961|OG001|Outcome|Lithium Plus Placebo Phase I|This is not a relevant category for this outcome. This outcome is only assessed in Phase II.
10981254|NCT00961961|OG002|Outcome|Lithium Plus Fluoxetine Phase II|Includes participants who completed Phase I and were assigned randomly to continue on their medications in Phase II (double-blind, as the fluoxetine and placebo were identical in appearance.
10981255|NCT00961961|OG003|Outcome|Lithium Plus Placebo Phase II|Includes participants who completed Phase I and were assigned randomly to switch from fluoxetine to placebo in Phase II (double-blind, as the fluoxetine and placebo were identical in appearance).
10981256|NCT00961961|OG000|Outcome|Lithium Plus Fluoxetine Phase I|All participants began with both medications in Phase I, which led into Phase II.
10981257|NCT00961961|OG001|Outcome|Lithium Plus Placebo Phase I|No participant was on placebo in Phase I. Only during Phase II.
10981258|NCT00961961|OG003|Outcome|Lithium Plus Placebo Phase II|Participants randomized to this condition were switched from fluoxetine to placebo. However, the fluoxetine pills were made to look like the placebo pills, to maintain the double-blind.
10981259|NCT00961961|OG000|Outcome|Lithium Plus Fluoxetine|Lithium / Fluoxetine: Individualized Daily Dosage
10981260|NCT00961961|OG001|Outcome|Lithium Plus Placebo|Lithium / Placebo: Individualized Daily Dosage
10981261|NCT00961961|OG003|Outcome|Lithium Plus Placebo Phase II|Participants randomized to this condition remained on active medications. However, the fluoxetine pills were made to look like the placebo pills, to maintain the double-blind.
10981262|NCT00961961|EG000|Reported Event|Lithium Plus Fluoxetine Phase I|This is the condition that all participants started in. They were given Lithium plus Fluoxetine and, if they responded, they were asked to accept random assignment to Phase II.
10981263|NCT00961961|EG001|Reported Event|Lithium Plus Placebo Phase I|No one was on placebo in Phase I.
10981264|NCT00961961|EG002|Reported Event|Lithium Plus Fluoxetine Phase II|These are the patients randomly assigned to stay on the fluoxetine in Phase II.
10981265|NCT00961961|EG003|Reported Event|Lithium Plus Placebo Phase II|These are the patients randomly assigned to switch to placebo from fluoxetine in Phase II.
10981266|NCT00962000|BG000|Baseline|All Study Participants|All subjects who participated in the study.
10981267|NCT00962000|FG000|Participant Flow|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
10981268|NCT00962000|FG001|Participant Flow|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
10981269|NCT00962000|OG000|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
10981270|NCT00962000|OG001|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
10981271|NCT00962000|EG000|Reported Event|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
10981272|NCT00962000|EG001|Reported Event|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
10981273|NCT00962013|BG000|Baseline|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
10981274|NCT00962013|FG000|Participant Flow|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
10981275|NCT00962013|OG000|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
10981276|NCT00962013|EG000|Reported Event|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
10981277|NCT00962039|BG000|Baseline|Citalopram|This double blind, placebo-controlled trial randomized 81 subjects ages 7 to 18 years in parallel groups to citalopram (n=40) or placebo (n=41) for 8 weeks. Citalopram was initiated at 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects. Subjects were recruited by clinical referral from both the primary care and specialty pediatric gastroenterology clinical settings. In addition to meeting criteria for FAP, subjects were required to be significantly impaired as reflected by a score of less than 70 on the Children's Global Assessment Scale (CGAS). Potential subjects with physical disease responsible for the observed abdominal pain, eating disorder, bipolar disorder, psychosis, alcohol/drug abuse, intellectual disability (IQ < 70), pregnancy, or prior trial of SSRI antidepressant or venlafaxine were excluded.
10981278|NCT00962039|BG001|Baseline|Placebo|This double blind, placebo-controlled trial randomized 81 subjects ages 7 to 18 years in parallel groups to citalopram (n=40) or placebo (n=41) for 8 weeks. Citalopram was initiated at 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects. Subjects were recruited by clinical referral from both the primary care and specialty pediatric gastroenterology clinical settings. In addition to meeting criteria for FAP, subjects were required to be significantly impaired as reflected by a score of less than 70 on the Children's Global Assessment Scale (CGAS). Potential subjects with physical disease responsible for the observed abdominal pain, eating disorder, bipolar disorder, psychosis, alcohol/drug abuse, intellectual disability (IQ < 70), pregnancy, or prior trial of SSRI antidepressant or venlafaxine were excluded.
10981279|NCT00962039|BG002|Baseline|Total|Total of all reporting groups
10981280|NCT00962039|FG000|Participant Flow|Citalopram|Citlaopram: Participants were randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects.
10981281|NCT00962039|FG001|Participant Flow|Placebo|Placebo: Participants were randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects.
10981282|NCT00962039|OG000|Outcome|Citalopram|"Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S > 2).~Citalopram: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects."
10981283|NCT00962039|OG001|Outcome|Placebo|"Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.~Placebo: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects."
10981284|NCT00962039|EG000|Reported Event|Citalopram|Citlaopram: Participants were randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects.
10981285|NCT00962039|EG001|Reported Event|Placebo|Placebo: Participants were randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects.
10981286|NCT00962065|BG000|Baseline|Low Dose|A low dose of LX4211; daily oral intake for 28 days
10981287|NCT00962065|BG001|Baseline|High Dose|A high dose of LX4211; daily oral intake for 28 days
10981288|NCT00962065|BG002|Baseline|Placebo|Matching placebo dosing with daily oral intake for 28 days
10981289|NCT00962065|BG003|Baseline|Total|Total of all reporting groups
10981290|NCT00962065|FG000|Participant Flow|Low Dose|A low dose of LX4211; daily oral intake for 28 days
10981291|NCT00962065|FG001|Participant Flow|High Dose|A high dose of LX4211; daily oral intake for 28 days
10981292|NCT00962065|FG002|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 28 days
10981293|NCT00962065|OG000|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
10981294|NCT00962065|OG001|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
10981295|NCT00962065|OG002|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
10981296|NCT00962065|EG000|Reported Event|Low Dose|A low dose of LX4211; daily oral intake for 28 days
10981297|NCT00962065|EG001|Reported Event|High Dose|A high dose of LX4211; daily oral intake for 28 days
10981298|NCT00962065|EG002|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 28 days
10981299|NCT00962078|BG000|Baseline|Interval Training|"interval training in lung transplant candidates~interval training: at 100 percent of peak Watt"
10981300|NCT00962078|BG001|Baseline|Continuous Training|"continuous training in lung transplant candidates~continuous endurance training: at 60 percent of peak Watt"
10981301|NCT00962078|BG002|Baseline|Total|Total of all reporting groups
10981302|NCT00962078|FG000|Participant Flow|Interval Training|"interval training in lung transplant candidates~interval training: at 100 percent of peak Watt"
10981303|NCT00962078|FG001|Participant Flow|Continuous Training|"continuous training in lung transplant candidates~continuous endurance training: at 60 percent of peak Watt"
10981304|NCT00962078|OG000|Outcome|Interval Training|"interval training in lung transplant candidates~interval training: at 100 percent of peak Watt"
10981305|NCT00962078|OG001|Outcome|Continuous Training|"continuous training in lung transplant candidates~continuous endurance training: at 60 percent of peak Watt"
10981306|NCT00962078|EG000|Reported Event|Interval Training|"interval training in lung transplant candidates~interval training: at 100 percent of peak Watt"
10981307|NCT00962078|EG001|Reported Event|Continuous Training|"continuous training in lung transplant candidates~continuous endurance training: at 60 percent of peak Watt"
10981308|NCT00962091|BG000|Baseline|Dose Escalation Cohort|A single dose of alisertib 15 mg, oral solution (OS) was administered on Day 1, followed by alisertib 40 mg, powder-in-capsule (PIC), orally, twice a day (BID) on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle. A single dose of alisertib 50 mg PIC, orally, was administered on Cycle 2 Day 1 followed by alisertib 40 mg on Days 3 through 9, followed by a 14-day rest period in Cycle 2 in a 23-day cycle. Subsequent cycles, alisertib 40 or 50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981309|NCT00962091|BG001|Baseline|Part A: Relative Bioavailability OS/PIC (Sequence A)|A single dose of alisertib 25 mg, OS, administered on Day 1, followed by alisertib 40 mg PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. A single dose of alisertib 50 mg PIC, orally, administered on Cycle 2 Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in a 23-day cycle. Subsequent cycles, alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981310|NCT00962091|BG002|Baseline|Part A: Relative Bioavailability PIC/OS (Sequence B)|A single dose of alisertib 50 mg, PIC, orally administered on Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. Cycle 2 Day 1 alisertib 25 mg, OS, once on Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in a 23-day cycle. Subsequent cycles followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981311|NCT00962091|BG003|Baseline|Part B: OS Food Effect Fed/Fasted (Sequence A)|Alisertib 35 mg (35 mg = relative bioavailability estimate in Part A as dose of OS that was calculated to yield the area under the concentration time curve of a 50-mg PIC dose): A single dose of alisertib 35 mg oral solution (OS), in fed state, administered on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. Cycle 2 Day 1 alisertib 35 mg administered, OS, in fasted state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 3 onwards, participants received alisertib 40 mg, PIC, orally, BID on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted, based on individual tolerance, followed by a 14-day rest period, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981312|NCT00962091|BG004|Baseline|Part B: OS Food Effect Fasted/Fed (Sequence B)|A single dose of alisertib 35 mg, OS, in fasted state, administered on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 2 Day 1 alisertib 30 mg, OS administered in fed state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 3 onwards, participants received alisertib 40 mg PIC, orally, BID on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981313|NCT00962091|BG005|Baseline|Part C: ECT Food Effect Fed/Fasted (Sequence A)|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 40 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle, followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 40 or 50 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 2 in a 23-day cycle. Cycle 3 onwards, participants were administered alisertib 40 mg BID ECT on Days 1-7 with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981314|NCT00962091|BG006|Baseline|Part C: ECT Food Effect Fasted/Fed (Sequence B)|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 40 mg, ECT, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle, followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 40 or 50 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 2, a 23-day cycle. Cycle 3 onwards participants were administered alisertib 40 mg BID ECT on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981315|NCT00962091|BG007|Baseline|Total|Total of all reporting groups
10981316|NCT00962091|FG000|Participant Flow|Dose Escalation Cohort|A single dose of alisertib 15 mg, oral solution (OS) was administered on Day 1, followed by alisertib 40 mg, powder-in-capsule (PIC), orally, twice a day (BID) on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle. A single dose of alisertib 50 mg PIC, orally, was administered on Cycle 2 Day 1 followed by alisertib 40 mg on Days 3 through 9, followed by a 14-day rest period in Cycle 2 in a 23-day cycle. Subsequent cycles, alisertib 40 or 50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981317|NCT00962091|FG001|Participant Flow|Part A: Relative Bioavailability OS/PIC (Sequence A)|A single dose of alisertib 25 mg, OS, administered on Day 1, followed by alisertib 40 mg PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. A single dose of alisertib 50 mg PIC, orally, administered on Cycle 2 Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in a 23-day cycle. Subsequent cycles, alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981318|NCT00962091|FG002|Participant Flow|Part A: Relative Bioavailability PIC/OS (Sequence B)|A single dose of alisertib 50 mg, PIC, orally administered on Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. Cycle 2 Day 1 alisertib 25 mg, OS, once on Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in a 23-day cycle. Subsequent cycles followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981319|NCT00962091|FG003|Participant Flow|Part B: OS Food Effect Fed/Fasted (Sequence A)|Alisertib 35 mg (35 mg = relative bioavailability estimate in Part A as dose of OS that was calculated to yield the area under the concentration time curve of a 50-mg PIC dose): A single dose of alisertib 35 mg oral solution (OS), in fed state, administered on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. Cycle 2 Day 1 alisertib 35 mg administered, OS, in fasted state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 3 onwards, participants received alisertib 40 mg, PIC, orally, BID on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted, based on individual tolerance, followed by a 14-day rest period, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
11007091|NCT01089413|OG001|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
10981320|NCT00962091|FG004|Participant Flow|Part B: OS Food Effect Fasted/Fed (Sequence B)|A single dose of alisertib 35 mg, OS, in fasted state, administered on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 2 Day 1 alisertib 30 mg, OS administered in fed state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 3 onwards, participants received alisertib 40 mg PIC, orally, BID on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981321|NCT00962091|FG005|Participant Flow|Part C: ECT Food Effect Fed/Fasted (Sequence A)|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 40 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle, followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 40 or 50 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 2 in a 23-day cycle. Cycle 3 onwards, participants were administered alisertib 40 mg BID ECT on Days 1-7 with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981322|NCT00962091|FG006|Participant Flow|Part C: ECT Food Effect Fasted/Fed (Sequence B)|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 40 mg, ECT, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle, followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 40 or 50 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 2, a 23-day cycle. Cycle 3 onwards participants were administered alisertib 40 mg BID ECT on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981323|NCT00962091|OG000|Outcome|Part A: Alisertib OS|Alisertib 25 mg, OS, once on Day 1 in Cycle 1 or Cycle 2.
10981324|NCT00962091|OG001|Outcome|Part A: Alisertib PIC|Alisertib 50 mg, PIC, orally once on Day 1 in Cycle 1 or Cycle 2.
10981325|NCT00962091|OG000|Outcome|Part B: Alisertib OS (Fed State)|Alisertib 35 mg (35 mg = relative bioavailability estimate in Part A as dose of OS that was calculated to yield the area under the concentration time curve of a 50-mg PIC dose): Alisertib 35 mg oral solution (OS), in fed state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle.
10981326|NCT00962091|OG001|Outcome|Part B: Alisertib OS (Fasted State)|Alisertib 35 mg, OS, in fasted state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle.
10981327|NCT00962091|OG000|Outcome|Part B: OS Food Effect Fed/Fasted (Sequence A)|Alisertib 35 mg (35 mg = relative bioavailability estimate in Part A as dose of OS that was calculated to yield the area under the concentration time curve of a 50-mg PIC dose): A single dose of alisertib 35 mg oral solution (OS), in fed state, administered on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. Cycle 2 Day 1 alisertib 35 mg administered, OS, in fasted state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 3 onwards, participants received alisertib 40 mg, PIC, orally, BID on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted, based on individual tolerance, followed by a 14-day rest period, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981328|NCT00962091|OG001|Outcome|Part B: OS Food Effect Fasted/Fed (Sequence B)|A single dose of alisertib 35 mg, OS, in fasted state, administered on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 2 Day 1 alisertib 30 mg, OS administered in fed state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 3 onwards, participants received alisertib 40 mg PIC, orally, BID on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981329|NCT00962091|OG000|Outcome|Part C: Alisertib ECT (Fasted State)|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 40 mg, ECT, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle.
10981330|NCT00962091|OG001|Outcome|Part C: Alisertib ECT (Fed State)|Alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 40 mg, ECT, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 or Cycle 2.
10981331|NCT00962091|OG000|Outcome|Dose Escalation Cohort|A single dose of alisertib 15 mg, oral solution (OS) was administered on Day 1, followed by alisertib 40 mg, powder-in-capsule (PIC), orally, twice a day (BID) on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle. A single dose of alisertib 50 mg PIC, orally, was administered on Cycle 2 Day 1 followed by alisertib 40 mg on Days 3 through 9, followed by a 14-day rest period in Cycle 2 in a 23-day cycle. Subsequent cycles, alisertib 40 or 50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981332|NCT00962091|OG001|Outcome|Part A: Relative Bioavailability|Alisertib 25 or 50 mg, OS, once on Day 1, in alternating dosage in Cycles 1 and 2, followed by alisertib 40 mg PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycles 1 and 2, in 23-day cycles, followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
11007092|NCT01089413|OG002|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
10981333|NCT00962091|OG002|Outcome|Part B: OS Food Effect|Alisertib 35 mg (35 mg = relative bioavailability estimate in Part A as dose of OS that was calculated to yield the area under the concentration time curve of a 50-mg PIC dose), OS, once on Day 1, in alternating fed/fasted states in Cycles 1 and 2, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in Cycle 1 and 2, in 23-day cycles, followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981334|NCT00962091|OG003|Outcome|Part C: ECT Food Effect|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, in alternating fed/fasted states in Cycles 1 and 2, followed by alisertib 40 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 and Cycle 2 in 23-day cycles, followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981335|NCT00962091|OG001|Outcome|Part A: Relative Bioavailability OS/PIC (Sequence A)|A single dose of alisertib 25 mg, OS, administered on Day 1, followed by alisertib 40 mg PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. A single dose of alisertib 50 mg PIC, orally, administered on Cycle 2 Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in a 23-day cycle. Subsequent cycles, alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981336|NCT00962091|OG002|Outcome|Part A: Relative Bioavailability PIC/OS (Sequence B)|A single dose of alisertib 50 mg, PIC, orally administered on Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. Cycle 2 Day 1 alisertib 25 mg, OS, once on Day 1, followed by alisertib 40 mg, PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in a 23-day cycle. Subsequent cycles followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981337|NCT00962091|OG003|Outcome|Part B: OS Food Effect Fed/Fasted (Sequence A)|Alisertib 35 mg (35 mg = relative bioavailability estimate in Part A as dose of OS that was calculated to yield the area under the concentration time curve of a 50-mg PIC dose): A single dose of alisertib 35 mg oral solution (OS), in fed state, administered on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in Cycle 1, in a 23-day cycle. Cycle 2 Day 1 alisertib 35 mg administered, OS, in fasted state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 3 onwards, participants received alisertib 40 mg, PIC, orally, BID on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted, based on individual tolerance, followed by a 14-day rest period, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981338|NCT00962091|OG004|Outcome|Part B: OS Food Effect Fasted/Fed (Sequence B)|A single dose of alisertib 35 mg, OS, in fasted state, administered on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 2 Day 1 alisertib 30 mg, OS administered in fed state, once on Day 1, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in a 23-day cycle. Cycle 3 onwards, participants received alisertib 40 mg PIC, orally, BID on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981339|NCT00962091|OG005|Outcome|Part C: ECT Food Effect Fed/Fasted (Sequence A)|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 40 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle, followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 40 or 50 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 2 in a 23-day cycle. Cycle 3 onwards, participants were administered alisertib 40 mg BID ECT on Days 1-7 with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981340|NCT00962091|OG006|Outcome|Part C: ECT Food Effect Fasted/Fed (Sequence B)|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 40 mg, ECT, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle, followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 40 or 50 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 2, a 23-day cycle. Cycle 3 onwards participants were administered alisertib 40 mg BID ECT on Days 1-7, with dose reduction to 30 mg BID or escalation to 50 mg BID permitted based on individual tolerance, followed by a 14-day rest period, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981341|NCT00962091|EG000|Reported Event|Dose Escalation Cohort|A single dose of alisertib 15 mg, oral solution (OS) was administered on Day 1, followed by alisertib 40 mg, powder-in-capsule (PIC), orally, twice a day (BID) on Days 3 through 9, followed by a 14-day rest period in Cycle 1 in a 23-day cycle. A single dose of alisertib 50 mg PIC, orally, was administered on Cycle 2 Day 1 followed by alisertib 40 mg on Days 3 through 9, followed by a 14-day rest period in Cycle 2 in a 23-day cycle. Subsequent cycles, alisertib 40 or 50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
11098982|NCT01579084|OG003|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
10981342|NCT00962091|EG001|Reported Event|Part A: Relative Bioavailability|Alisertib 25 or 50 mg, OS, once on Day 1, in alternating dosage in Cycles 1 and 2, followed by alisertib 40 mg PIC, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycles 1 and 2, in 23-day cycles, followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1 through 7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981343|NCT00962091|EG002|Reported Event|Part B: OS Food Effect|Alisertib 35 mg (35 mg = relative bioavailability estimate in Part A as dose of OS that was calculated to yield the area under the concentration time curve of a 50-mg PIC dose), OS, once on Day 1, in alternating fed/fasted states in Cycles 1 and 2, followed by alisertib 30 mg, OS, BID on Days 3-9, followed by a 14-day rest period in Cycle 1 and 2, in 23-day cycles, followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981344|NCT00962091|EG003|Reported Event|Part C: ECT Food Effect|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, in alternating fed/fasted states in Cycles 1 and 2, followed by alisertib 40 mg, ECT, orally, BID on Days 3 through 9, followed by a 14-day rest period in Cycle 1 and Cycle 2 in 23-day cycles, followed by alisertib 40-50 mg (individual dosage based on tolerability in Cycles 1 and 2), PIC, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3, in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity, or the start of another anticancer therapy.
10981345|NCT00962104|BG000|Baseline|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
10981346|NCT00962104|BG001|Baseline|Placebo|Taken by mouth, once daily for 10 weeks.
10981347|NCT00962104|BG002|Baseline|Total|Total of all reporting groups
10981348|NCT00962104|FG000|Participant Flow|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
10981349|NCT00962104|FG001|Participant Flow|Placebo|Taken by mouth, once daily for 10 weeks.
10981350|NCT00962104|OG000|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
10981351|NCT00962104|OG001|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
10981352|NCT00962104|EG000|Reported Event|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
10981353|NCT00962104|EG001|Reported Event|Placebo|Taken by mouth, once daily for 10 weeks.
10981354|NCT00962208|BG000|Baseline|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
10981355|NCT00962208|BG001|Baseline|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
10981356|NCT00962208|BG002|Baseline|Total|Total of all reporting groups
10981357|NCT00962208|FG000|Participant Flow|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
10981358|NCT00962208|FG001|Participant Flow|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
10981359|NCT00962208|OG000|Outcome|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
10981360|NCT00962208|OG001|Outcome|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
10981361|NCT00962208|EG000|Reported Event|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
10981362|NCT00962208|EG001|Reported Event|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
10981363|NCT00962247|BG000|Baseline|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
10981364|NCT00962247|FG000|Participant Flow|Sedentary; Usual, 25% Reduced, 50% Reduced|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
10981365|NCT00962247|OG000|Outcome|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
10981366|NCT00962247|OG001|Outcome|25% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 25% from the usual sedentary condition using a television reduction device (TV Allowance)~Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
10981367|NCT00962247|OG002|Outcome|50% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 50% from the usual sedentary condition using a television reduction device (TV Allowance)~Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
10981368|NCT00962247|EG000|Reported Event|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
10981369|NCT00962390|BG000|Baseline|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
10981370|NCT00962390|BG001|Baseline|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
10981371|NCT00962390|BG002|Baseline|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
10981372|NCT00962390|BG003|Baseline|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
10981373|NCT00962390|BG004|Baseline|Total|Total of all reporting groups
10981374|NCT00962390|FG000|Participant Flow|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
10981375|NCT00962390|FG001|Participant Flow|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
10981376|NCT00962390|FG002|Participant Flow|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
10981377|NCT00962390|FG003|Participant Flow|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
10981378|NCT00962390|OG000|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
10981379|NCT00962390|OG001|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
10981380|NCT00962390|OG002|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
10981381|NCT00962390|OG003|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
10981382|NCT00962390|EG000|Reported Event|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
10981383|NCT00962390|EG001|Reported Event|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
10981384|NCT00962390|EG002|Reported Event|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
10981385|NCT00962390|EG003|Reported Event|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
10981386|NCT00962585|BG000|Baseline|S-equol 10 mg BID|20 mg total daily dose of S-equol
10981387|NCT00962585|BG001|Baseline|S-equol 50 mg BID|100 mg total daily dose of S-equol
10981388|NCT00962585|BG002|Baseline|S-equol 150 mg BID|300 mg total daily dose of S-equol
10981389|NCT00962585|BG003|Baseline|Placebo|Placebo treatment arm
10981390|NCT00962585|BG004|Baseline|Total|Total of all reporting groups
10981391|NCT00962585|FG000|Participant Flow|S-equol 10 mg BID|20 mg total daily dose of S-equol
10981392|NCT00962585|FG001|Participant Flow|S-equol 50 mg BID|100 mg total daily dose of S-equol
10981393|NCT00962585|FG002|Participant Flow|S-equol 150 mg BID|300 mg total daily dose of S-equol
10981394|NCT00962585|FG003|Participant Flow|Placebo|Placebo treatment arm
10981395|NCT00962585|OG000|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
10981396|NCT00962585|OG001|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
10981397|NCT00962585|OG002|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
10981398|NCT00962585|OG003|Outcome|Placebo|Placebo treatment arm
10981399|NCT00962585|OG000|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
10981400|NCT00962585|OG001|Outcome|Placebo|Placebo treatment arm
10981401|NCT00962585|EG000|Reported Event|S-equol 10 mg BID|20 mg total daily dose of S-equol
10981402|NCT00962585|EG001|Reported Event|S-equol 50 mg BID|100 mg total daily dose of S-equol
10981403|NCT00962585|EG002|Reported Event|S-equol 150 mg BID|300 mg total daily dose of S-equol
10981404|NCT00962585|EG003|Reported Event|Placebo|Placebo treatment arm
10981405|NCT00962598|BG000|Baseline|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
10981406|NCT00962598|BG001|Baseline|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
10981407|NCT00962598|BG002|Baseline|Total|Total of all reporting groups
10981408|NCT00962598|FG000|Participant Flow|Corn Oil|Corn oil: The dosage correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
11007093|NCT01089413|OG003|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
10874005|NCT00430677|EG000|Reported Event|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: In the double-blind period, participants received abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57. In the open-label period, participants received abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
10874006|NCT00430677|EG001|Reported Event|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: Participants received abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent.
10874007|NCT00430677|EG002|Reported Event|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
10874008|NCT00430716|BG000|Baseline|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
10874009|NCT00430716|BG001|Baseline|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
10874010|NCT00430716|BG002|Baseline|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
10874011|NCT00430716|BG003|Baseline|Total|Total of all reporting groups
10874012|NCT00430716|FG000|Participant Flow|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
10874013|NCT00430716|FG001|Participant Flow|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
10874014|NCT00430716|FG002|Participant Flow|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
10874015|NCT00430716|OG000|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
10874016|NCT00430716|OG001|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
10874017|NCT00430716|OG002|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
10874018|NCT00430716|EG000|Reported Event|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
10874019|NCT00430716|EG001|Reported Event|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
10874020|NCT00430716|EG002|Reported Event|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
10874021|NCT00430755|BG000|Baseline|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
10874022|NCT00430755|FG000|Participant Flow|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
10874023|NCT00430755|OG000|Outcome|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
10874024|NCT00430755|EG000|Reported Event|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
10874025|NCT00430768|BG000|Baseline|Group 1 Low Dose|"6.9 x10e12 vector genomes~Group 1 receives rAAV1-CB-hAAT 6.9 x1012 vg (vector genomes), e"
10874026|NCT00430768|BG001|Baseline|Group 2 Middle Dose|"2.1 x 10e13 vector genomes~Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
10874027|NCT00430768|BG002|Baseline|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
10874028|NCT00430768|BG003|Baseline|Total|Total of all reporting groups
10874029|NCT00430768|FG000|Participant Flow|Group 1 Low Dose|"6.9 x10e12 vector genomes (vg)~Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg."
10874030|NCT00430768|FG001|Participant Flow|Group 2 Middle Dose|"2.1 x 10e13 vector genomes; 2.2 x 10e13 vector genomes~Group 2, 1 subject received rAAV1-CB-hAAT 2.1 x10e13 vg; 202 and 203 received rAAV1-CB-hAAT 2.2 x10e13 vg"
10874031|NCT00430768|FG002|Participant Flow|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
10874032|NCT00430768|OG000|Outcome|Group 1 Low Dose|
10874033|NCT00430768|OG001|Outcome|Group 2 Middle Dose|
10874034|NCT00430768|OG002|Outcome|Group 3 High Dose|
10874035|NCT00430768|OG000|Outcome|201 (Medium Dose)|Subject 201 M-specific AAT Level
10874036|NCT00430768|OG001|Outcome|202 (Medium Dose)|Subject 202 M-specific AAT Level
10874037|NCT00430768|OG002|Outcome|203 (Medium Dose)|Subject 203 M-specific AAT Level
10874038|NCT00430768|OG003|Outcome|301 (High Dose)|Subject 301M-specific AAT Level
10874039|NCT00430768|OG004|Outcome|302 (High Dose)|Subject 302 M-specific AAT Level
10874040|NCT00430768|OG005|Outcome|303 (High Dose)|Subject 303 M-specific AAT Level
10874041|NCT00430768|EG000|Reported Event|Group 1 Low Dose|"6.9 x10e12 vector genomes~e. Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg (vector genomes)"
10874042|NCT00430768|EG001|Reported Event|Group 2 Middle Dose|"2.2 x 10e13 vector genomes~Group 2 receives rAAV1-CB-hAAT 2.1 x10e13 vg"
10981409|NCT00962598|FG001|Participant Flow|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
10981410|NCT00962598|OG000|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
10981411|NCT00962598|OG001|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
10981412|NCT00962598|EG000|Reported Event|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
10981413|NCT00962598|EG001|Reported Event|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
10981414|NCT00962650|BG000|Baseline|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
10981415|NCT00962650|FG000|Participant Flow|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
10981416|NCT00962650|OG000|Outcome|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
10981417|NCT00962650|EG000|Reported Event|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
10981418|NCT00962741|BG000|Baseline|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
10981419|NCT00962741|FG000|Participant Flow|Etanercept|Etanercept was administered 0.8 milligram/kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
10981420|NCT00962741|OG000|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
10981421|NCT00962741|EG000|Reported Event|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
10981422|NCT00962754|BG000|Baseline|Physician Insight Fluid Balance|physician has insight in the fluid balance data
10981423|NCT00962754|BG001|Baseline|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance data (fluid balance chart is blinded)
10981424|NCT00962754|BG002|Baseline|Total|Total of all reporting groups
10981425|NCT00962754|FG000|Participant Flow|Physician Insight Fluid Balance|Physician has insight in the fluid balance chart
10981426|NCT00962754|FG001|Participant Flow|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance chart
10981427|NCT00962754|OG000|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in fluid balance chart, ie the fluid balance chart is masked
10981428|NCT00962754|OG001|Outcome|Control Group (Insight in Fluid Balance)|physician has insight in (full access to) the fluid balance chart data
10981429|NCT00962754|OG000|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in the fluid balance chart data (masked)
10981430|NCT00962754|OG001|Outcome|Control Group (Insight in Fluid Balance)|Physician has insight in (full access to) the fluid balance chart data
10981431|NCT00962754|OG000|Outcome|Physician Insight Fluid Balance|Physician has insight (full access to) in the fluid balance chart data
10981432|NCT00962754|OG001|Outcome|Physician no Insight Fluid Balance Chart|physician has no insight in the fluid balance data (masked)
10981433|NCT00962754|EG000|Reported Event|Physician Insight Fluid Balance|physician has insight in (full access to) the fluid balance chart data
10981434|NCT00962754|EG001|Reported Event|Physician no Insight Fluid Balance Chart|Physician has no insight in the fluid balance chart data (masked)
10981435|NCT00962780|BG000|Baseline|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
10981436|NCT00962780|BG001|Baseline|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
10981437|NCT00962780|BG002|Baseline|Total|Total of all reporting groups
10874043|NCT00430768|EG002|Reported Event|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
10874044|NCT00430781|BG000|Baseline|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
10874045|NCT00430781|BG001|Baseline|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
10874046|NCT00430781|BG002|Baseline|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
10874047|NCT00430781|BG003|Baseline|Total|Total of all reporting groups
10874048|NCT00430781|FG000|Participant Flow|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
10874049|NCT00430781|FG001|Participant Flow|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
10874050|NCT00430781|FG002|Participant Flow|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
10874051|NCT00430781|OG000|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
10874052|NCT00430781|OG001|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
10874053|NCT00430781|OG002|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
10874054|NCT00430781|OG000|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
10874055|NCT00430781|OG001|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
10874056|NCT00430781|OG002|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
10874057|NCT00430781|EG000|Reported Event|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
10874058|NCT00430781|EG001|Reported Event|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
10874059|NCT00430781|EG002|Reported Event|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
10874060|NCT00430937|BG000|Baseline|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
10874061|NCT00430937|BG001|Baseline|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
10874062|NCT00430937|BG002|Baseline|Total|Total of all reporting groups
10874063|NCT00430937|FG000|Participant Flow|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
10874064|NCT00430937|FG001|Participant Flow|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
10874065|NCT00430937|OG000|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
10874066|NCT00430937|OG001|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
10874067|NCT00430937|EG000|Reported Event|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
10874068|NCT00430937|EG001|Reported Event|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
10874069|NCT00430989|BG000|Baseline|N2O Group (FiO2 0.3)|Nitrous Oxide as an inspired concentration of 70% in 30% Oxygen
10874070|NCT00430989|BG001|Baseline|N2O Free Group (FiO2 0.3)|Nitrous Oxide free air and inspired Oxygen concentration of 30%
10874071|NCT00430989|BG002|Baseline|Total|Total of all reporting groups
10874072|NCT00430989|FG000|Participant Flow|Nitrous Oxide Group|General anaesthesia containing Nitrous oxide and fraction of inspired oxygen of 30%
10874073|NCT00430989|FG001|Participant Flow|No Nitrous Oxide|General anaesthesia not containing Nitrous oxide with fraction of inspired oxygen of 30%
10874074|NCT00430989|OG000|Outcome|Nitrous Oxide: 70% N2O (FiO2 0.3)|"N2O Group (FiO2 0.3)~Nitrous Oxide: 70% N2O V's No N2O~Nitrous Oxide: N2O 70% v's No N2O"
10874075|NCT00430989|OG001|Outcome|N2O Free Group (FiO2 0.3)|"N2O free group (FiO2 0.3)~Nitrous Oxide: 70% N2O V's No N2O~Nitrous Oxide: N2O 70% v's No N2O"
10874076|NCT00430989|OG000|Outcome|N2O Group (FiO2 0.3)|N2O Group (FiO2 0.3)
10874077|NCT00430989|OG001|Outcome|N2O Free Group (FiO2 0.3)|N2O free group (FiO2 0.3)
10874078|NCT00430989|EG000|Reported Event|Nitrous Oxide: 70% N2O|"N2O Group (FiO2 0.3)~Nitrous Oxide: 70% N2O V's No N2O~General anaesthesia containing Nitrous oxide and fraction of inspired oxygen of 30%"
10874079|NCT00430989|EG001|Reported Event|Nitrous Oxide Free|"Nitrous Oxide free group (FiO2 0.3)~Nitrous Oxide: N2O 70% v's No N2O~General anaesthesia not containing Nitrous oxide and fraction of inspired oxygen of 30%"
10874080|NCT00431041|BG000|Baseline|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
10874081|NCT00431041|BG001|Baseline|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
10874082|NCT00431041|BG002|Baseline|Total|Total of all reporting groups
10874083|NCT00431041|FG000|Participant Flow|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
10874084|NCT00431041|FG001|Participant Flow|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
10874085|NCT00431041|OG000|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
10874086|NCT00431041|OG001|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
10874087|NCT00431041|EG000|Reported Event|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
10874088|NCT00431041|EG001|Reported Event|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
10874089|NCT00431067|BG000|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
10874090|NCT00431067|FG000|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
10981438|NCT00962780|FG000|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
10981439|NCT00962780|FG001|Participant Flow|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
10981440|NCT00962780|OG000|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
10981441|NCT00962780|OG000|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
10981442|NCT00962780|OG001|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
10981443|NCT00962780|OG002|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
10981444|NCT00962780|EG000|Reported Event|Prior 13vPnC Dose 1|Participants >=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.
10981445|NCT00962780|EG001|Reported Event|13vPnC Dose 1|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.
10981446|NCT00962780|EG002|Reported Event|13vPnC Dose 2|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.
10981447|NCT00962780|EG003|Reported Event|13vPnC Dose 3|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.
10981448|NCT00962780|EG004|Reported Event|23vPS Dose|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.
10981449|NCT00962780|EG005|Reported Event|Follow-up|Participants >=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
10981450|NCT00962871|BG000|Baseline|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981451|NCT00962871|BG001|Baseline|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981452|NCT00962871|BG002|Baseline|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981453|NCT00962871|BG003|Baseline|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
10981454|NCT00962871|BG004|Baseline|Total|Total of all reporting groups
10981455|NCT00962871|FG000|Participant Flow|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981456|NCT00962871|FG001|Participant Flow|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981457|NCT00962871|FG002|Participant Flow|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981458|NCT00962871|FG003|Participant Flow|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
10981459|NCT00962871|OG000|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981460|NCT00962871|OG001|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981461|NCT00962871|OG002|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981462|NCT00962871|OG003|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
10981463|NCT00962871|EG000|Reported Event|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981464|NCT00962871|EG001|Reported Event|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981465|NCT00962871|EG002|Reported Event|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
10981466|NCT00962871|EG003|Reported Event|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
10981467|NCT00962949|BG000|Baseline|Control|"Healthy controls~Angiotensin II: Angiotensin II infusion for 1 hour"
10981468|NCT00962949|BG001|Baseline|Postural Tachycardia Syndrome|"Patients with Postural Tachycardia Syndrome~Angiotensin II: Angiotensin II infusion for 1 hour"
10981469|NCT00962949|BG002|Baseline|Total|Total of all reporting groups
10981470|NCT00962949|FG000|Participant Flow|Control|"Healthy controls~Angiotensin II: Angiotensin II infusion for 1 hour"
10981471|NCT00962949|FG001|Participant Flow|Postural Tachycardia Syndrome|"Patients with Postural Tachycardia Syndrome~Angiotensin II: Angiotensin II infusion for 1 hour"
10981472|NCT00962949|OG000|Outcome|Control|"Healthy controls~Angiotensin II: Angiotensin II infusion for 1 hour"
10981473|NCT00962949|OG001|Outcome|Postural Tachycardia Syndrome|"Patients with Postural Tachycardia Syndrome~Angiotensin II: Angiotensin II infusion for 1 hour"
10981474|NCT00962949|EG000|Reported Event|Control|"Healthy controls~Angiotensin II: Angiotensin II infusion for 1 hour"
10981475|NCT00962949|EG001|Reported Event|Postural Tachycardia Syndrome|"Patients with Postural Tachycardia Syndrome~Angiotensin II: Angiotensin II infusion for 1 hour"
10981476|NCT00963105|BG000|Baseline|Lenalidomide 5 mg|Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
10981477|NCT00963105|BG001|Baseline|Lenalidomide 10 mg|Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
10981478|NCT00963105|BG002|Baseline|Lenalidomide 15 mg|Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
10981479|NCT00963105|BG003|Baseline|Total|Total of all reporting groups
10981480|NCT00963105|FG000|Participant Flow|Lenalidomide 5 mg|Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug.
10981481|NCT00963105|FG001|Participant Flow|Lenalidomide 10 mg|Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug.
10981482|NCT00963105|FG002|Participant Flow|Lenalidomide 15 mg|Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug.
10981483|NCT00963105|OG000|Outcome|Lenalidomide 5 mg|Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
10981484|NCT00963105|OG001|Outcome|Lenalidomide 10 mg|Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
10981485|NCT00963105|OG002|Outcome|Lenalidomide 15 mg|Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
10981486|NCT00963105|EG000|Reported Event|Lenalidomide 5 mg|Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug.
10981487|NCT00963105|EG001|Reported Event|Lenalidomide 10 mg|Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug.
10981488|NCT00963105|EG002|Reported Event|Lenalidomide 15 mg|Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug.
10981489|NCT00963157|BG000|Baseline|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981490|NCT00963157|BG001|Baseline|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981491|NCT00963157|BG002|Baseline|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
10981492|NCT00963157|BG003|Baseline|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981493|NCT00963157|BG004|Baseline|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
10981494|NCT00963157|BG005|Baseline|Total|Total of all reporting groups
10981495|NCT00963157|FG000|Participant Flow|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981496|NCT00963157|FG001|Participant Flow|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981497|NCT00963157|FG002|Participant Flow|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
10981498|NCT00963157|FG003|Participant Flow|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981499|NCT00963157|FG004|Participant Flow|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
10981500|NCT00963157|OG000|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981501|NCT00963157|OG001|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981502|NCT00963157|OG002|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
10981503|NCT00963157|OG003|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981504|NCT00963157|OG004|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
10981505|NCT00963157|EG000|Reported Event|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981506|NCT00963157|EG001|Reported Event|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981507|NCT00963157|EG002|Reported Event|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
10981508|NCT00963157|EG003|Reported Event|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
10981509|NCT00963157|EG004|Reported Event|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
10981510|NCT00963235|BG000|Baseline|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
10981511|NCT00963235|FG000|Participant Flow|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
10981512|NCT00963235|OG000|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
10981513|NCT00963235|EG000|Reported Event|13vPnC (After Dose 1 and Before Dose 2)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2.
10981514|NCT00963235|EG001|Reported Event|13vPnC (After Dose 2 and Before Dose 3)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3.
10981515|NCT00963235|EG002|Reported Event|13vPnC (After Dose 3 and Before Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3.
10981516|NCT00963235|EG003|Reported Event|13vPnC (After Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.
10981517|NCT00963430|BG000|Baseline|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10981518|NCT00963430|BG001|Baseline|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10981519|NCT00963430|BG002|Baseline|Total|Total of all reporting groups
10981520|NCT00963430|FG000|Participant Flow|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10981521|NCT00963430|FG001|Participant Flow|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10981522|NCT00963430|OG000|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10981523|NCT00963430|OG001|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10981524|NCT00963430|EG000|Reported Event|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10981525|NCT00963430|EG001|Reported Event|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
10981526|NCT00963482|BG000|Baseline|Intervention Group|Cognitive-behavioural smoking cessation program
10981527|NCT00963482|BG001|Baseline|Control Group|Autogenic training
10981528|NCT00963482|BG002|Baseline|Total|Total of all reporting groups
10981529|NCT00963482|FG000|Participant Flow|Intervention Group|Cognitive-behavioural smoking cessation program
10981530|NCT00963482|FG001|Participant Flow|Control Group|Autogenic training
10981531|NCT00963482|OG000|Outcome|Intervention Group|Cognitive-behavioural smoking cessation program
10981532|NCT00963482|OG001|Outcome|Control Group|Autogenic training
10981533|NCT00963482|EG000|Reported Event|Intervention Group|Cognitive-behavioural smoking cessation program
10981534|NCT00963482|EG001|Reported Event|Control Group|Autogenic training
10981535|NCT00963508|BG000|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
10981536|NCT00963508|BG001|Baseline|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
10981537|NCT00963508|BG002|Baseline|Total|Total of all reporting groups
10981538|NCT00963508|FG000|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
10981539|NCT00963508|FG001|Participant Flow|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
10981540|NCT00963508|OG000|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
10981541|NCT00963508|OG001|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
10981542|NCT00963508|EG000|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
10981543|NCT00963508|EG001|Reported Event|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
10981544|NCT00963547|BG000|Baseline|Pt. 1: MK-2206 45mg, QOD + Trastuzumab|Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981545|NCT00963547|BG001|Baseline|Pt. 1: MK-2206 60mg, QOD + Trastuzumab|Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981546|NCT00963547|BG002|Baseline|Pt. 1: MK-2206 135mg, QW + Trastuzumab|Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981547|NCT00963547|BG003|Baseline|Pt. 1: MK-2206 200mg, QW + Trastuzumab|Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981548|NCT00963547|BG004|Baseline|Total|Total of all reporting groups
10981549|NCT00963547|FG000|Participant Flow|Pt. 1: MK-2206 45mg, QOD + Trastuzumab|Participants in Part 1 (Pt. 1) receive MK-2206 45 mg every other day (QOD), taken orally. In combination with MK-2206, trastuzumab is administered by intravenous (IV) infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg every 3 weeks (q3wk).
10981550|NCT00963547|FG001|Participant Flow|Pt. 1: MK-2206 60mg, QOD + Trastuzumab|Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981551|NCT00963547|FG002|Participant Flow|Pt. 1: MK-2206 135mg, QW + Trastuzumab|Participants in Pt. 1 receive MK-2206 135 mg once weekly (QW), taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981552|NCT00963547|FG003|Participant Flow|Pt. 1: MK-2206 200mg, QW + Trastuzumab|Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981553|NCT00963547|FG004|Participant Flow|Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 500mg, QD|Participants in Part 2 (Pt. 2) receive MK-2206 (dosed either QOD or QW) taken orally at the maximum tolerated dose defined in Part 1 (Pt. 1 MTD). MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 500 mg taken orally once daily (QD).
10981554|NCT00963547|FG005|Participant Flow|Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 750mg, QD|Participants in Pt. 2 receive MK-2206 (dosed either QOD or QW) taken orally at the Pt. 1 MTD. MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 750 mg taken orally QD.
10981555|NCT00963547|FG006|Participant Flow|Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 1000mg, QD|Participants in Pt. 2 receive MK-2206 (dosed either QOD or QW) taken orally at the Pt. 1 MTD. MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 1000 mg taken orally QD.
10981556|NCT00963547|OG000|Outcome|Pt. 1: MK-2206 45mg, QOD + Trastuzumab|Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981557|NCT00963547|OG001|Outcome|Pt. 1: MK-2206 60mg, QOD + Trastuzumab|Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981558|NCT00963547|OG002|Outcome|Pt. 1: MK-2206 135mg, QW + Trastuzumab|Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
11098983|NCT01579084|EG000|Reported Event|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
10981559|NCT00963547|OG003|Outcome|Pt. 1: MK-2206 200mg, QW + Trastuzumab|Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981560|NCT00963547|OG000|Outcome|Pt. 1: MK-2206 (QOD Dosing) + Trastuzumab|Participants in Pt. 1 receive MK-2206 (at 45 or 60 mg) QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981561|NCT00963547|OG001|Outcome|Pt. 1: MK-2206 (QW Dosing) + Trastuzumab|Participants in Pt. 1 receive MK-2206 (135 or 200 mg) QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981562|NCT00963547|OG002|Outcome|Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib|Participants in Pt. 2 receive MK-2206 (dosed either QOD or QW) taken orally at the Pt. 1 MTD. MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib at 500, 750, or 1000 mg taken orally QD.
10981563|NCT00963547|EG000|Reported Event|Pt. 1: MK-2206 45mg, QOD + Trastuzumab|Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981564|NCT00963547|EG001|Reported Event|Pt. 1: MK-2206 60mg, QOD + Trastuzumab|Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981565|NCT00963547|EG002|Reported Event|Pt. 1: MK-2206 135mg, QW + Trastuzumab|Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981566|NCT00963547|EG003|Reported Event|Pt. 1: MK-2206 200mg, QW + Trastuzumab|Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
10981567|NCT00963560|BG000|Baseline|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
10981568|NCT00963560|BG001|Baseline|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
10981569|NCT00963560|BG002|Baseline|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
10981570|NCT00963560|BG003|Baseline|Total|Total of all reporting groups
10981571|NCT00963560|FG000|Participant Flow|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
10981572|NCT00963560|FG001|Participant Flow|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
10981573|NCT00963560|FG002|Participant Flow|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
10981574|NCT00963560|OG000|Outcome|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
10981575|NCT00963560|OG001|Outcome|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
10981576|NCT00963560|OG002|Outcome|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
10981577|NCT00963560|EG000|Reported Event|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
10981578|NCT00963560|EG001|Reported Event|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
10981579|NCT00963560|EG002|Reported Event|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
10981580|NCT00963638|BG000|Baseline|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
10981581|NCT00963638|BG001|Baseline|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
10981582|NCT00963638|BG002|Baseline|Total|Total of all reporting groups
10981583|NCT00963638|FG000|Participant Flow|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
10981584|NCT00963638|FG001|Participant Flow|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
10981585|NCT00963638|OG000|Outcome|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
10981586|NCT00963638|OG001|Outcome|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
10981587|NCT00963638|EG000|Reported Event|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
10981588|NCT00963638|EG001|Reported Event|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
10981589|NCT00963677|BG000|Baseline|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
10981590|NCT00963677|BG001|Baseline|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
10981591|NCT00963677|BG002|Baseline|Total|Total of all reporting groups
10981592|NCT00963677|FG000|Participant Flow|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
10981593|NCT00963677|FG001|Participant Flow|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
10981594|NCT00963677|OG000|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
10981595|NCT00963677|OG001|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
10981596|NCT00963677|EG000|Reported Event|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
10981597|NCT00963677|EG001|Reported Event|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
10981598|NCT00963807|BG000|Baseline|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
10981599|NCT00963807|FG000|Participant Flow|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
10981600|NCT00963807|OG000|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
10981601|NCT00963807|OG000|Outcome|Responders|RECIST responders based on CT measurements performed after 2 cycles of neoadjuvant therapy.
10981602|NCT00963807|OG001|Outcome|Non-Responders|RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
10981603|NCT00963807|EG000|Reported Event|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
10981604|NCT00963820|BG000|Baseline|Overall Study|Safety Population
10981605|NCT00963820|FG000|Participant Flow|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981606|NCT00963820|FG001|Participant Flow|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981607|NCT00963820|FG002|Participant Flow|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981608|NCT00963820|FG003|Participant Flow|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981609|NCT00963820|FG004|Participant Flow|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981610|NCT00963820|FG005|Participant Flow|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981611|NCT00963820|FG006|Participant Flow|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981612|NCT00963820|FG007|Participant Flow|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981613|NCT00963820|FG008|Participant Flow|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established Maximum Tolerated Dose (MTD), capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981614|NCT00963820|FG009|Participant Flow|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
11098984|NCT01579084|EG001|Reported Event|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
10981615|NCT00963820|FG010|Participant Flow|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981616|NCT00963820|FG011|Participant Flow|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981617|NCT00963820|OG000|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981618|NCT00963820|OG001|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981619|NCT00963820|OG002|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981620|NCT00963820|OG003|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981621|NCT00963820|OG004|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981622|NCT00963820|OG005|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981623|NCT00963820|OG006|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981624|NCT00963820|OG007|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981625|NCT00963820|OG008|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981626|NCT00963820|OG009|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981627|NCT00963820|OG010|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981628|NCT00963820|OG011|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981629|NCT00963820|OG005|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981630|NCT00963820|EG000|Reported Event|Dose Escalation Cohorts|Ixazomib citrate, 0.24 to 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Dose Escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981631|NCT00963820|EG001|Reported Event|Expansion Cohorts|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Expansion Period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
10981632|NCT00963859|BG000|Baseline|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
10981633|NCT00963859|FG000|Participant Flow|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
10981634|NCT00963859|OG000|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
10981635|NCT00963859|EG000|Reported Event|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
10981636|NCT00963872|BG000|Baseline|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
10981637|NCT00963872|BG001|Baseline|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
10981638|NCT00963872|BG002|Baseline|Total|Total of all reporting groups
10981639|NCT00963872|FG000|Participant Flow|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
10981640|NCT00963872|FG001|Participant Flow|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
10981641|NCT00963872|OG000|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
10981642|NCT00963872|OG001|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
10981643|NCT00963872|EG000|Reported Event|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
10981644|NCT00963872|EG001|Reported Event|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
10981645|NCT00963911|BG000|Baseline|Eligible Patients|Patients older than 70 years and were included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)).
10981646|NCT00963911|FG000|Participant Flow|Included Patients|Patients older than 70 years
10981647|NCT00963911|OG000|Outcome|Eligible Patients Assessable for the Primary Outcome Measure|Patients older than 70 years and included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)), and for whom G8 as well as at least one instrument of the multidimensional assessment were available.
10981648|NCT00963911|EG000|Reported Event|Included Patients|"Screening tests (G8 and VES-13)~The G-8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and selfrated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14.~VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment.~Multidimensional geriatric assessment: Patients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G)."
10981649|NCT00963924|BG000|Baseline|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
10981650|NCT00963924|BG001|Baseline|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
10981651|NCT00963924|BG002|Baseline|Total|Total of all reporting groups
10981652|NCT00963924|FG000|Participant Flow|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
10981653|NCT00963924|FG001|Participant Flow|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
10981654|NCT00963924|OG000|Outcome|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
10981655|NCT00963924|OG001|Outcome|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
10981656|NCT00963924|OG000|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
10981657|NCT00963924|OG001|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
10981658|NCT00963924|EG000|Reported Event|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
10981659|NCT00963924|EG001|Reported Event|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
10981660|NCT00963937|BG000|Baseline|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
10981661|NCT00963937|BG001|Baseline|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
10981662|NCT00963937|BG002|Baseline|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
10981663|NCT00963937|BG003|Baseline|Total|Total of all reporting groups
10981664|NCT00963937|FG000|Participant Flow|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
10981665|NCT00963937|FG001|Participant Flow|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
10981666|NCT00963937|FG002|Participant Flow|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
10981667|NCT00963937|OG000|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
10981668|NCT00963937|OG001|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
10981669|NCT00963937|OG001|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
10981670|NCT00963937|OG002|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
10981671|NCT00963937|OG003|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
10981672|NCT00963937|EG000|Reported Event|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
10981673|NCT00963937|EG001|Reported Event|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
10981674|NCT00963937|EG002|Reported Event|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
10981675|NCT00963937|EG003|Reported Event|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
10981676|NCT00963989|BG000|Baseline|Penumbra Device Arm|Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
10981677|NCT00963989|FG000|Participant Flow|Penumbra Device Arm|Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
10981678|NCT00963989|OG000|Outcome|Penumbra Device Arm|Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
10981679|NCT00963989|EG000|Reported Event|Penumbra Device Arm|Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
10981680|NCT00964028|BG000|Baseline|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
10981681|NCT00964028|BG001|Baseline|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
10981682|NCT00964028|BG002|Baseline|Total|Total of all reporting groups
10981683|NCT00964028|FG000|Participant Flow|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
10981684|NCT00964028|FG001|Participant Flow|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
10981685|NCT00964028|OG000|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
10981686|NCT00964028|OG001|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
10981687|NCT00964028|EG000|Reported Event|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
10981688|NCT00964028|EG001|Reported Event|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
10981689|NCT00964119|BG000|Baseline|Single Cohort Observational|
10981690|NCT00964119|FG000|Participant Flow|Single Cohort Obervational|
10981691|NCT00964119|OG000|Outcome|Single Cohort Observational|
10981692|NCT00964119|EG000|Reported Event|Single Cohort Observational|
10981693|NCT00964158|BG000|Baseline|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981694|NCT00964158|BG001|Baseline|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981695|NCT00964158|BG002|Baseline|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981696|NCT00964158|BG003|Baseline|Total|Total of all reporting groups
10981697|NCT00964158|FG000|Participant Flow|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981698|NCT00964158|FG001|Participant Flow|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981699|NCT00964158|FG002|Participant Flow|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981700|NCT00964158|OG000|Outcome|GSK2340272A Group|Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981701|NCT00964158|OG000|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981702|NCT00964158|OG001|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981703|NCT00964158|OG002|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981704|NCT00964158|OG000|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981705|NCT00964158|OG001|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981706|NCT00964158|EG000|Reported Event|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981707|NCT00964158|EG001|Reported Event|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981708|NCT00964158|EG002|Reported Event|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
10981709|NCT00964223|BG000|Baseline|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
10981710|NCT00964223|FG000|Participant Flow|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
10981711|NCT00964223|OG000|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
10981712|NCT00964223|OG001|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
10981713|NCT00964223|EG000|Reported Event|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
10981714|NCT00964353|BG000|Baseline|Control|"Estimated Effective Warfarin dosing calculations are based on clinical data algorithms~Warfarin: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose."
10981715|NCT00964353|BG001|Baseline|Experimental|"Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.~Warfarin: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose."
10981716|NCT00964353|BG002|Baseline|Total|Total of all reporting groups
10981717|NCT00964353|FG000|Participant Flow|Control|Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
10981718|NCT00964353|FG001|Participant Flow|Experimental|Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
10981719|NCT00964353|OG000|Outcome|Control|Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
10981720|NCT00964353|OG001|Outcome|Experimental|Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
10981721|NCT00964353|EG000|Reported Event|Control|Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
10981722|NCT00964353|EG001|Reported Event|Experimental|Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
10981723|NCT00964366|BG000|Baseline|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
10981724|NCT00964366|BG001|Baseline|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
10981725|NCT00964366|BG002|Baseline|Total|Total of all reporting groups
10981726|NCT00964366|FG000|Participant Flow|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
10981727|NCT00964366|FG001|Participant Flow|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
10981728|NCT00964366|OG000|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
10981729|NCT00964366|OG001|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
10981730|NCT00964366|EG000|Reported Event|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
10981731|NCT00964366|EG001|Reported Event|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
10981732|NCT00964392|BG000|Baseline|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
10981733|NCT00964392|BG001|Baseline|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
10981734|NCT00964392|BG002|Baseline|Total|Total of all reporting groups
10981735|NCT00964392|FG000|Participant Flow|More-Experienced Physicians (MEP)|MEP are defined as those who have performed greater than 50 AF ablation cases per year.
10981736|NCT00964392|FG001|Participant Flow|Less-Experienced Physicians (LEP)|LEP are defined as those who have performed less than or equal to 50 AF ablations per year.
10981737|NCT00964392|OG000|Outcome|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
10981738|NCT00964392|OG001|Outcome|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
10981739|NCT00964392|EG000|Reported Event|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
10981740|NCT00964392|EG001|Reported Event|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
10981741|NCT00964431|BG000|Baseline|Indomethacin Test (Lower Dose)|
10981742|NCT00964431|BG001|Baseline|Indomethacin Test (Upper Dose)|Single dose
10981743|NCT00964431|BG002|Baseline|Celecoxib 400 mg|
10981744|NCT00964431|BG003|Baseline|Placebo|
10981745|NCT00964431|BG004|Baseline|Total|Total of all reporting groups
10981746|NCT00964431|FG000|Participant Flow|Indomethacin Test (Lower Dose)|
10981747|NCT00964431|FG001|Participant Flow|Indomethacin Test (Upper Dose)|Single dose
10981748|NCT00964431|FG002|Participant Flow|Celecoxib 400 mg|
10981749|NCT00964431|FG003|Participant Flow|Placebo|
10981750|NCT00964431|OG000|Outcome|Indomethacin Test (Lower Dose)|20-mg
10981751|NCT00964431|OG001|Outcome|Indomethacin Test (Upper Dose)|40-mg
10981752|NCT00964431|OG002|Outcome|Celecoxib 400 mg|
10981753|NCT00964431|OG003|Outcome|Placebo|
10981754|NCT00964431|EG000|Reported Event|Indomethacin Test (Lower Dose)|
10981755|NCT00964431|EG001|Reported Event|Indomethacin Test (Upper Dose)|Single dose
10981756|NCT00964431|EG002|Reported Event|Celecoxib 400 mg|
10981757|NCT00964431|EG003|Reported Event|Placebo|
10981758|NCT00964444|BG000|Baseline|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
10981759|NCT00964444|FG000|Participant Flow|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
10981760|NCT00964444|OG000|Outcome|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
10981761|NCT00964444|EG000|Reported Event|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
10981762|NCT00964496|BG000|Baseline|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
10981763|NCT00964496|BG001|Baseline|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
10981764|NCT00964496|BG002|Baseline|Total|Total of all reporting groups
10981765|NCT00964496|FG000|Participant Flow|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
10981766|NCT00964496|FG001|Participant Flow|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
10981767|NCT00964496|OG000|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
10981768|NCT00964496|OG001|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
10981769|NCT00964496|EG000|Reported Event|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
10981770|NCT00964496|EG001|Reported Event|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
10981771|NCT00964548|BG000|Baseline|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
10981772|NCT00964548|BG001|Baseline|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
10981773|NCT00964548|BG002|Baseline|Total|Total of all reporting groups
10981774|NCT00964548|FG000|Participant Flow|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
10981775|NCT00964548|FG001|Participant Flow|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
10981776|NCT00964548|OG000|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
10981777|NCT00964548|OG001|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
10981778|NCT00964548|EG000|Reported Event|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
10981779|NCT00964548|EG001|Reported Event|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
10981780|NCT00964678|BG000|Baseline|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
10981781|NCT00964678|FG000|Participant Flow|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
10981782|NCT00964678|OG000|Outcome|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
10981783|NCT00964678|OG000|Outcome|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
10981784|NCT00964678|EG000|Reported Event|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
10981785|NCT00964743|BG000|Baseline|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
10981786|NCT00964743|FG000|Participant Flow|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
11098985|NCT01579084|EG002|Reported Event|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
10981787|NCT00964743|OG000|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
10981788|NCT00964743|EG000|Reported Event|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
10981789|NCT00964782|BG000|Baseline|Sildenafil Crossover to Placebo|Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.
10981790|NCT00964782|BG001|Baseline|Placebo Crossover to Sidenafil|Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
10981791|NCT00964782|BG002|Baseline|Total|Total of all reporting groups
10981792|NCT00964782|FG000|Participant Flow|Sildenafil Crossover to Placebo|Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.
10981793|NCT00964782|FG001|Participant Flow|Placebo Crossover to Sidenafil|Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
10981794|NCT00964782|OG000|Outcome|Sildenafil Crossover to Placebo|Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.
10981795|NCT00964782|OG001|Outcome|Placebo Crossover to Sidenafil|Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
10981796|NCT00964782|OG000|Outcome|Sildenafil|Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises. This repeated test will occur on a separate date, not to exceed 3 months from baseline.
10981797|NCT00964782|OG001|Outcome|Placebo|Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises. This repeated test will occur on a separate date, not to exceed 3 months from baseline.
10981798|NCT00964782|EG000|Reported Event|Sildenafil Crossed Over to Placebo|Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.
10981799|NCT00964782|EG001|Reported Event|Placebo Crossed Over to Sildenafil|Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
10981800|NCT00964795|BG000|Baseline|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
10981801|NCT00964795|FG000|Participant Flow|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
10981802|NCT00964795|OG000|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
10981803|NCT00964795|OG000|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
10981804|NCT00964795|EG000|Reported Event|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
10981805|NCT00964860|BG000|Baseline|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
10981806|NCT00964860|BG001|Baseline|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
10981807|NCT00964860|BG002|Baseline|Total|Total of all reporting groups
10981808|NCT00964860|FG000|Participant Flow|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
10981809|NCT00964860|FG001|Participant Flow|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
10981810|NCT00964860|OG000|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
10981811|NCT00964860|OG001|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
10981812|NCT00964860|EG000|Reported Event|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
10981813|NCT00964860|EG001|Reported Event|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
10981814|NCT00964886|BG000|Baseline|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
10981815|NCT00964886|BG001|Baseline|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
10981816|NCT00964886|BG002|Baseline|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
10981817|NCT00964886|BG003|Baseline|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
10981818|NCT00964886|BG004|Baseline|Total|Total of all reporting groups
10981819|NCT00964886|FG000|Participant Flow|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
10981820|NCT00964886|FG001|Participant Flow|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
10981821|NCT00964886|FG002|Participant Flow|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
10981822|NCT00964886|FG003|Participant Flow|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
10981823|NCT00964886|OG000|Outcome|Arm 1 + Arm 3|"Factor desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
10981824|NCT00964886|OG001|Outcome|Arm 2 + Arm 4|"Factor anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
10981825|NCT00964886|OG000|Outcome|Arm 1 + Arm 3|Factor all participants assigned at baseline to receive desipramine hydrochloride
10981826|NCT00964886|OG001|Outcome|Arm 2 + Arm 4|Factor all participants assigned at baseline to receive benztropine mesylate (active placebo)
10981827|NCT00964886|OG000|Outcome|Arm 2 + Arm 3|"Factor cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
10981828|NCT00964886|OG001|Outcome|Arm 1 + Arm 4|Factor no cognitive behavioral therapy
10981829|NCT00964886|OG000|Outcome|Arm 2 + Arm 3|Factor all participants assigned at baseline to receive cognitive behavioral therapy
10981830|NCT00964886|OG001|Outcome|Arm 1 + Arm 4|Factor all participants assigned at baseline not to receive cognitive behavioral therapy
10981831|NCT00964886|EG000|Reported Event|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
10981832|NCT00964886|EG001|Reported Event|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
10981833|NCT00964886|EG002|Reported Event|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
10981834|NCT00964886|EG003|Reported Event|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
11098986|NCT01579084|EG003|Reported Event|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10981835|NCT00965081|BG000|Baseline|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
10981836|NCT00965081|BG001|Baseline|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
10981837|NCT00965081|BG002|Baseline|Total|Total of all reporting groups
10981838|NCT00965081|FG000|Participant Flow|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
10981839|NCT00965081|FG001|Participant Flow|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
10981840|NCT00965081|OG000|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
10981841|NCT00965081|OG001|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
10981842|NCT00965081|EG000|Reported Event|Placebo|Placebo (inactive capsules identical in appearance to duloxetine capsules) daily by mouth at the same time each day for 12 weeks.
10981843|NCT00965081|EG001|Reported Event|Duloxetine 30 mg|Duloxetine 30 mg dose daily by mouth at the same time each day for 12 weeks
10981844|NCT00965081|EG002|Reported Event|Duloxetine 60 mg|Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
10981845|NCT00965094|BG000|Baseline|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
10981846|NCT00965094|BG001|Baseline|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
10981847|NCT00965094|BG002|Baseline|Total|Total of all reporting groups
10981848|NCT00965094|FG000|Participant Flow|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
10981849|NCT00965094|FG001|Participant Flow|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
10981850|NCT00965094|OG000|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
10981851|NCT00965094|OG001|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
11098987|NCT01579084|EG004|Reported Event|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10981852|NCT00965094|OG001|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
10981853|NCT00965094|EG000|Reported Event|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
10981854|NCT00965094|EG001|Reported Event|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
10981855|NCT00965185|BG000|Baseline|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
10981856|NCT00965185|BG001|Baseline|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
10981857|NCT00965185|BG002|Baseline|Total|Total of all reporting groups
10981858|NCT00965185|FG000|Participant Flow|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
10981859|NCT00965185|FG001|Participant Flow|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
10981860|NCT00965185|OG000|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
10981861|NCT00965185|OG001|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
10981862|NCT00965185|OG000|Outcome|Atorvastatin|"20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.~atorvastatin: 20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months."
10981863|NCT00965185|OG001|Outcome|Placebo|Placebo: Placebo
10981864|NCT00965185|EG000|Reported Event|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
10981865|NCT00965185|EG001|Reported Event|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
10981866|NCT00965237|BG000|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
10981867|NCT00965237|FG000|Participant Flow|Multifocal CL / Single Vision CL+ Reading Glasses|Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
10981868|NCT00965237|FG001|Participant Flow|Single Vision CL + Reading Glasses / Multifocal CL|Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
10981869|NCT00965237|OG000|Outcome|Lotrafilcon B Multifocal Contact Lens|Commercially marketed, lotrafilcon B, silicone hydrogel, multifocal contact lens for daily wear use
10981870|NCT00965237|OG001|Outcome|Lotrafilcon B Single Vision Contact Lens + Reading Glasses|Commercially marketed, lotrafilcon B, silicone hydrogel, single vision contact lenses for daily wear use, with over-reader spectacles worn as needed
10981871|NCT00965237|EG000|Reported Event|Multifocal Contact Lens|Commercially marketed lotrafilcon B multifocal contact lenses
10981872|NCT00965237|EG001|Reported Event|Single Vision Contact Lens|Commercially marketed lotrafilcon B single vision contact lenses
10981873|NCT00965250|BG000|Baseline|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
10981874|NCT00965250|BG001|Baseline|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
10981875|NCT00965250|BG002|Baseline|Total|Total of all reporting groups
10981876|NCT00965250|FG000|Participant Flow|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
10981877|NCT00965250|FG001|Participant Flow|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
10981878|NCT00965250|OG000|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
10981879|NCT00965250|OG001|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
10981880|NCT00965250|OG000|Outcome|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
10981881|NCT00965250|EG000|Reported Event|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
10981882|NCT00965263|BG000|Baseline|Low Dose Vaccine (82μg)|"All participants were vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9."
10981883|NCT00965263|BG001|Baseline|High Dose Vaccine (360μg)|"All participants were vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9."
10981884|NCT00965263|BG002|Baseline|Total|Total of all reporting groups
10981885|NCT00965263|FG000|Participant Flow|Low Dose Vaccine|"All participants were vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9."
10981886|NCT00965263|FG001|Participant Flow|High Dose Vaccine|"All participants were vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9."
10981887|NCT00965263|OG000|Outcome|Week 1 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981888|NCT00965263|OG001|Outcome|Week 3 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981889|NCT00965263|OG002|Outcome|Week 5 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981890|NCT00965263|OG003|Outcome|Week 7 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981891|NCT00965263|OG004|Outcome|Week 9 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981892|NCT00965263|OG005|Outcome|Week 11 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981893|NCT00965263|OG006|Outcome|Week 13 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981894|NCT00965263|OG007|Outcome|Week 1 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981895|NCT00965263|OG008|Outcome|Week 3 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981896|NCT00965263|OG009|Outcome|Week 5 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981897|NCT00965263|OG010|Outcome|Week 7 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981898|NCT00965263|OG011|Outcome|Week 9 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981899|NCT00965263|OG012|Outcome|Week 11 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981900|NCT00965263|OG013|Outcome|Week 13 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
10981901|NCT00965263|OG000|Outcome|Low Antibody/0mg Cocaine|Low Antibody/0mg Cocaine.
10981902|NCT00965263|OG001|Outcome|Low Antibody/25mg Cocaine|Low Antibody/25mg Cocaine.
10981903|NCT00965263|OG002|Outcome|Low Antibody/50mg Cocaine|Low Antibody/50mg Cocaine.
10981904|NCT00965263|OG003|Outcome|High Antibody/0mg Cocaine|High Antibody/0mg Cocaine.
10981905|NCT00965263|OG004|Outcome|High Antibody/25mg Cocaine|High Antibody/25mg Cocaine.
10981906|NCT00965263|OG005|Outcome|High Antibody/50mg Cocaine|High Antibody/50mg Cocaine.
10981907|NCT00965263|EG000|Reported Event|Low Dose Vaccine|"Each of four participants was vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9."
10981908|NCT00965263|EG001|Reported Event|High Dose Vaccine|"Each of six participants was vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9."
10981909|NCT00965341|BG000|Baseline|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
10981910|NCT00965341|BG001|Baseline|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
10981911|NCT00965341|BG002|Baseline|Total|Total of all reporting groups
10981912|NCT00965341|FG000|Participant Flow|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
10981913|NCT00965341|FG001|Participant Flow|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
10981914|NCT00965341|OG000|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
10981915|NCT00965341|OG001|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
10981916|NCT00965341|EG000|Reported Event|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
10981917|NCT00965341|EG001|Reported Event|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
10981918|NCT00965419|BG000|Baseline|All Participants|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
10981919|NCT00965419|FG000|Participant Flow|Edivoxetine|Edivoxetine: 0.1 milligram (mg)/kilogram (kg)/day or participant specific known stable dose, rollover participants (LNBJ [No NCT number]) and (LNBF [NCT00922636]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.
10981920|NCT00965419|OG000|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
10981921|NCT00965419|EG000|Reported Event|Edivoxetine (Open-Label)|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
10981922|NCT00965419|EG001|Reported Event|Edivoxetine (Follow Up)|The follow up period is an optional taper of Edivoxetine. Treatment may be tapered or discontinued, over a period of 10 to 18 days.
10981923|NCT00965458|BG000|Baseline|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
10981924|NCT00965458|BG001|Baseline|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
10981925|NCT00965458|BG002|Baseline|Total|Total of all reporting groups
10981926|NCT00965458|FG000|Participant Flow|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
10981927|NCT00965458|FG001|Participant Flow|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
10981928|NCT00965458|OG000|Outcome|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
10981929|NCT00965458|OG001|Outcome|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
10981930|NCT00965458|OG000|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
10981931|NCT00965458|OG001|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
10981932|NCT00965458|EG000|Reported Event|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
10981933|NCT00965458|EG001|Reported Event|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
10981934|NCT00965484|BG000|Baseline|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
10981935|NCT00965484|FG000|Participant Flow|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
10981936|NCT00965484|OG000|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
10981937|NCT00965484|EG000|Reported Event|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
10981938|NCT00965497|BG000|Baseline|Open-label, Single Arm|All patients will receive the intervention
10981939|NCT00965497|FG000|Participant Flow|Open-label, Single Arm|All patients will receive the intervention
10981940|NCT00965497|OG000|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
10981941|NCT00965497|EG000|Reported Event|Open-label, Single Arm|All patients will receive the intervention
10981942|NCT00965523|BG000|Baseline|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
10981943|NCT00965523|FG000|Participant Flow|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
10981944|NCT00965523|OG000|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
10981945|NCT00965523|EG000|Reported Event|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
10981946|NCT00965562|BG000|Baseline|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
10981947|NCT00965562|BG001|Baseline|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
10981948|NCT00965562|BG002|Baseline|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
10981949|NCT00965562|BG003|Baseline|Total|Total of all reporting groups
10981950|NCT00965562|FG000|Participant Flow|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
10981951|NCT00965562|FG001|Participant Flow|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
10981952|NCT00965562|FG002|Participant Flow|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
10981953|NCT00965562|OG000|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
10981954|NCT00965562|OG001|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
10981955|NCT00965562|OG002|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
10981956|NCT00965562|OG002|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
10981957|NCT00965562|EG000|Reported Event|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
10981958|NCT00965562|EG001|Reported Event|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
10981959|NCT00965562|EG002|Reported Event|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
10981960|NCT00965575|BG000|Baseline|Melatonin First Then Placebo|"Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks~Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects."
10981961|NCT00965575|BG001|Baseline|Placebo First Then Melatonin|"Subjects will take a placebo 30 minutes before bedtime for four weeks~Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects."
10981962|NCT00965575|BG002|Baseline|Total|Total of all reporting groups
10981963|NCT00965575|FG000|Participant Flow|Melatonin First Then Placebo|"Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks~Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects.~Cross over, so subjects who received melatonin in the first phase will receive placebo during the second phase and vice versa."
10981964|NCT00965575|FG001|Participant Flow|Placebo First Then Melatonin|"Subjects will take a placebo 30 minutes before bedtime for four weeks~Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects.~Cross over, so subjects who received melatonin in the first phase will receive placebo during the second phase and vice versa."
10981965|NCT00965575|OG000|Outcome|Melatonin|Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Taken 30 minutes prior to bedtime.
10981966|NCT00965575|OG001|Outcome|Placebo|Placebo: taken 30 minutes prior to bedtime
10981967|NCT00965575|OG000|Outcome|Melatonin|"Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks~Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects."
10981968|NCT00965575|OG001|Outcome|Placebo|"Subjects will take a placebo 30 minutes before bedtime for four weeks~Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects."
10981969|NCT00965575|EG000|Reported Event|Melatonin|"Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks~Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects."
10981970|NCT00965575|EG001|Reported Event|Placebo|"Subjects will take a placebo 30 minutes before bedtime for four weeks~Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects."
10981971|NCT00965718|BG000|Baseline|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
10981972|NCT00965718|FG000|Participant Flow|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
10981973|NCT00965718|OG000|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
10981974|NCT00965718|EG000|Reported Event|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
10981975|NCT00965731|BG000|Baseline|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
10981976|NCT00965731|BG001|Baseline|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
10981977|NCT00965731|BG002|Baseline|Total|Total of all reporting groups
10981978|NCT00965731|FG000|Participant Flow|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
10981979|NCT00965731|FG001|Participant Flow|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
10981980|NCT00965731|OG000|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
10981981|NCT00965731|OG001|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
10981982|NCT00965731|OG000|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
10981983|NCT00965731|OG001|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles
10981984|NCT00965731|OG001|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
10981985|NCT00965731|OG000|Outcome|PF-02341066 and Erlotinib|PF-02341033 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles
10981986|NCT00965731|OG000|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
11098988|NCT01579084|EG005|Reported Event|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
10981987|NCT00965731|EG000|Reported Event|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
10981988|NCT00965731|EG001|Reported Event|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
10981989|NCT00965848|BG000|Baseline|Entire Study Population|
10981990|NCT00965848|FG000|Participant Flow|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
10981991|NCT00965848|FG001|Participant Flow|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
10981992|NCT00965848|FG002|Participant Flow|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
10981993|NCT00965848|OG000|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
10981994|NCT00965848|OG001|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
10981995|NCT00965848|OG002|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
10981996|NCT00965848|EG000|Reported Event|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
10981997|NCT00965848|EG001|Reported Event|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
10981998|NCT00965848|EG002|Reported Event|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
10981999|NCT00966186|BG000|Baseline|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
10982000|NCT00966186|BG001|Baseline|Rotational Technique|
10982001|NCT00966186|BG002|Baseline|Total|Total of all reporting groups
10982002|NCT00966186|FG000|Participant Flow|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
10982003|NCT00966186|FG001|Participant Flow|Rotational Technique|
10982004|NCT00966186|OG000|Outcome|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
10982005|NCT00966186|OG001|Outcome|Rotational Technique|
10982006|NCT00966186|EG000|Reported Event|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
10982007|NCT00966186|EG001|Reported Event|Rotational Technique|
10982008|NCT00966238|BG000|Baseline|0.5 µg i.m.|
10982009|NCT00966238|BG001|Baseline|1.0 µg i.m.|
10982010|NCT00966238|BG002|Baseline|2.0 µg i.m.|
10982011|NCT00966238|BG003|Baseline|3.0 µg i.m.|
10982012|NCT00966238|BG004|Baseline|5.0 µg i.m.|
10982013|NCT00966238|BG005|Baseline|8.0 µg i.m.|
10982014|NCT00966238|BG006|Baseline|Total|Total of all reporting groups
10982015|NCT00966238|FG000|Participant Flow|0.5 µg i.m.|
10982016|NCT00966238|FG001|Participant Flow|1.0 µg i.m.|
10982017|NCT00966238|FG002|Participant Flow|2.0 µg i.m.|
10982018|NCT00966238|FG003|Participant Flow|3.0 µg i.m.|
10982019|NCT00966238|FG004|Participant Flow|5.0 µg i.m.|
10982020|NCT00966238|FG005|Participant Flow|8.0 µg i.m.|
10982021|NCT00966238|OG000|Outcome|0.5 µg i.m.|
10982022|NCT00966238|OG001|Outcome|1.0 µg i.m.|
10982023|NCT00966238|OG002|Outcome|2.0 µg i.m.|
10982024|NCT00966238|OG003|Outcome|3.0 µg i.m.|
10982025|NCT00966238|OG004|Outcome|5.0 µg i.m.|
10982026|NCT00966238|OG005|Outcome|8.0 µg i.m.|
10982027|NCT00966238|EG000|Reported Event|0.5 µg i.m.|
10982028|NCT00966238|EG001|Reported Event|1.0 µg i.m.|
10982029|NCT00966238|EG002|Reported Event|2.0 µg i.m.|
10982030|NCT00966238|EG003|Reported Event|3.0 µg i.m.|
10982031|NCT00966238|EG004|Reported Event|5.0 µg i.m.|
10982032|NCT00966238|EG005|Reported Event|8.0 µg i.m.|
10982033|NCT00966264|BG000|Baseline|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
10982034|NCT00966264|BG001|Baseline|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
10982035|NCT00966264|BG002|Baseline|Total|Total of all reporting groups
10982036|NCT00966264|FG000|Participant Flow|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
10982037|NCT00966264|FG001|Participant Flow|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
10982038|NCT00966264|OG000|Outcome|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
10982039|NCT00966264|OG001|Outcome|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
10982040|NCT00966264|EG000|Reported Event|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
10982041|NCT00966264|EG001|Reported Event|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
10982042|NCT00966277|BG000|Baseline|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
10982043|NCT00966277|BG001|Baseline|Group 2: Control|No Dalteparin study drug.
10982044|NCT00966277|BG002|Baseline|Total|Total of all reporting groups
10982045|NCT00966277|FG000|Participant Flow|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
10982046|NCT00966277|FG001|Participant Flow|Group 2: Control|No Dalteparin study drug (primary prophylaxis).
10982047|NCT00966277|OG000|Outcome|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
10982048|NCT00966277|OG001|Outcome|Group 2: Control|No Dalteparin study drug.
10982049|NCT00966277|EG000|Reported Event|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
10982050|NCT00966277|EG001|Reported Event|Group 2: Control|No Dalteparin study drug.
10982051|NCT00966355|BG000|Baseline|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
10982052|NCT00966355|BG001|Baseline|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
10982053|NCT00966355|BG002|Baseline|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
10982054|NCT00966355|BG003|Baseline|Total|Total of all reporting groups
10982055|NCT00966355|FG000|Participant Flow|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
10982056|NCT00966355|FG001|Participant Flow|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
10982057|NCT00966355|FG002|Participant Flow|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
10982058|NCT00966355|OG000|Outcome|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
10982059|NCT00966355|OG001|Outcome|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
10982060|NCT00966355|OG002|Outcome|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
10982061|NCT00966355|EG000|Reported Event|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
10982062|NCT00966355|EG001|Reported Event|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
10982063|NCT00966355|EG002|Reported Event|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
10982064|NCT00966433|BG000|Baseline|Spontaneous Ventilation|"Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.~Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery."
10982065|NCT00966433|BG001|Baseline|Pressure Support Ventilation|"Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.~Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery."
10982066|NCT00966433|BG002|Baseline|Pressure Control Ventilation|"Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.~Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery."
10982067|NCT00966433|BG003|Baseline|Total|Total of all reporting groups
10982068|NCT00966433|FG000|Participant Flow|Spontaneous Ventilation|"Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.~Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery."
10982069|NCT00966433|FG001|Participant Flow|Pressure Support Ventilation|"Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.~Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery."
10982070|NCT00966433|FG002|Participant Flow|Pressure Control Ventilation|"Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.~Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery."
10982071|NCT00966433|OG000|Outcome|Spontaneous Ventilation|"Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.~Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery"
10982072|NCT00966433|OG001|Outcome|Pressure Support Ventilation|"Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.~Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery."
10982073|NCT00966433|OG000|Outcome|Spontaneous Ventilation|"Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.~Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery."
10982074|NCT00966433|OG001|Outcome|Pressure Control Ventilation|"Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.~Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery."
11098989|NCT01579084|EG006|Reported Event|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
10982075|NCT00966433|OG000|Outcome|Pressure Support Ventilation|"Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.~Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery."
10982076|NCT00966433|EG000|Reported Event|Spontaneous Ventilation|"Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.~Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery."
10982077|NCT00966433|EG001|Reported Event|Pressure Support Ventilation|"Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.~Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery."
10982078|NCT00966433|EG002|Reported Event|Pressure Control Ventilation|"Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.~Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery."
10982079|NCT00966446|BG000|Baseline|Unsupervised Decolonization|"This group was randomized to the following decolonization protocol: 1) 2% mupirocin ointment applied inside both nares twice daily for seven days 2) a 4% chlorhexidine gluconate (Hibiclens, Mo¨lnlycke Health Care, Norcross, Georgia) body wash, including entire skin surface, excluding face and hair, with particular attention to axillae, inguinal region, and perirectal areas, performed on both the first and the last day of mupirocin use. Subjects were asked to record performance of each step of the decolonization protocol in a journal, which was returned at the end of the period of medication use, along with any unused portion of the mupirocin and chlorhexidine gluconate body wash containers. The subjects randomized to unsupervised decolonization were instructed on the decolonization protocol during the initial interview, along with the educational instruction as described in the no intervention group."
10982080|NCT00966446|BG001|Baseline|Supervised Decolonization|This group was also randomized to the decolonization protocol. In addition those randomized to supervised decolonization received daily phone calls or text messages during the decolonization protocol period in order to remind enrolled subjects to perform the indicated procedure in addition to the instruction and education received during the initial interview.
10982081|NCT00966446|BG002|Baseline|No Intervention|Households do not undergo active MRSA decolonization protocol. The received education only. The content of the education focused on personal hygiene (hand hygiene and bathing), interrupting transmission (avoidance of shared towels, razors, etc.), and household hygiene (regular washing of linens and towels, disposal of potentially infective materials such as bandages).
10982082|NCT00966446|BG003|Baseline|Total|Total of all reporting groups
10982083|NCT00966446|FG000|Participant Flow|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.~Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
10982084|NCT00966446|FG001|Participant Flow|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.~Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
10982085|NCT00966446|FG002|Participant Flow|No Intervention|Households do not undergo active MRSA decolonization protocol
10982086|NCT00966446|OG000|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
10982087|NCT00966446|OG001|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
10982088|NCT00966446|OG002|Outcome|No Intervention|No decolonization agents
10982089|NCT00966446|EG000|Reported Event|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.~Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
11007094|NCT01089413|EG000|Reported Event|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
11007095|NCT01089504|BG000|Baseline|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
11007096|NCT01089504|BG001|Baseline|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
10982090|NCT00966446|EG001|Reported Event|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.~Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
10982091|NCT00966446|EG002|Reported Event|No Intervention|Households do not undergo active MRSA decolonization protocol
10982092|NCT00966550|BG000|Baseline|Tomato First Then Non-tomato|"tomato High fat test meal~Tomato products: tomato with High fat test meal"
10982093|NCT00966550|BG001|Baseline|Non-tomato First Then Tomato|"Non-tomato high fat test meal~Non-tomato test meal: non-tomato with High fat test meal"
10982094|NCT00966550|BG002|Baseline|Total|Total of all reporting groups
10982095|NCT00966550|FG000|Participant Flow|Tomato First Then Non-tomato|Tomato :High fat meal with tomato
10982096|NCT00966550|FG001|Participant Flow|Non-tomato First Then Tomato|Non-tomato :High fat meal with non-tomato
10982097|NCT00966550|OG000|Outcome|Tomato|"High fat tomato test meal~Tomato products: High fat tomato test meal"
10982098|NCT00966550|OG001|Outcome|Non-tomato|"Non-tomato high fat test meal~Non-tomato test meal: High fat non-tomato test meal"
10982099|NCT00966550|EG000|Reported Event|Tomato|"High fat tomato test meal~Tomato products: High fat tomato test meal"
10982100|NCT00966550|EG001|Reported Event|Non-tomato|"Non-tomato high fat test meal~Non-tomato test meal: High fat non-tomato test meal"
10982101|NCT00966641|BG000|Baseline|All Study Participants|All study participants who were enrolled in the study.
10982102|NCT00966641|FG000|Participant Flow|PL3100 First, Then Naproxen|"First Intervention Period:~PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)~(after 7-14 day washout period)~Second Intervention Period:~Naproxen: Single orally administered dose of 500 mg naproxen"
10982103|NCT00966641|FG001|Participant Flow|Naproxen First, Then PL3100|"First Intervention Period:~Naproxen: Single orally administered dose of 500 mg naproxen~(after 7-14 day washout period)~Second Intervention Period:~PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)"
10982104|NCT00966641|OG000|Outcome|PL 3100|"Active experimental drug~PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
10982105|NCT00966641|OG001|Outcome|Naproxen|"Active comparator~Naproxen: Single orally administered dose of 500 mg naproxen"
10982106|NCT00966641|EG000|Reported Event|PL 3100|"Active experimental drug~PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
10982107|NCT00966641|EG001|Reported Event|Naproxen|"Active comparator~Naproxen: Single orally administered dose of 500 mg naproxen"
10982108|NCT00966693|BG000|Baseline|RTD (Cohort 1, Phase 1)|Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle
10982109|NCT00966693|BG001|Baseline|RTD (Cohort 2, Phase 1)|Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
10982110|NCT00966693|BG002|Baseline|RTD (Cohort 3, Phase 1)|Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle
10982111|NCT00966693|BG003|Baseline|RTD (Cohort 2, Phase 2)|Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
10982112|NCT00966693|BG004|Baseline|Total|Total of all reporting groups
10982113|NCT00966693|FG000|Participant Flow|RTD (Cohort 1, Phase 1)|Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle
10982114|NCT00966693|FG001|Participant Flow|RTD (Cohort 2, Phase 1)|Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone 40mg *21 days+ 7 days rest and reevaluation=28 day cycle
10982115|NCT00966693|FG002|Participant Flow|RTD (Cohort 3, Phase 1)|Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle
10982116|NCT00966693|FG003|Participant Flow|RTD (Cohort 2, Phase 2)|Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone 40mg *21 days+ 7 days rest and reevaluation=28 day cycle
10982117|NCT00966693|OG000|Outcome|RTD (Cohort 1, Phase 1)|Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle
10982118|NCT00966693|OG001|Outcome|RTD (Cohort 2, Phase 1)|Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
10982119|NCT00966693|OG002|Outcome|RTD (Cohort 3, Phase 1)|Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle
10982120|NCT00966693|OG003|Outcome|RTD (Cohort 2, Phase 2)|Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
10982121|NCT00966693|EG000|Reported Event|RTD (Cohort 1, Phase 1)|Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle
10982122|NCT00966693|EG001|Reported Event|RTD (Cohort 2, Phase 1)|Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
10982123|NCT00966693|EG002|Reported Event|RTD (Cohort 3, Phase 1)|Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle
10982124|NCT00966693|EG003|Reported Event|RTD (Cohort 2, Phase 2)|Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
10982125|NCT00966719|BG000|Baseline|Lactation Consultant|"In hospital meeting with lactation consultant~1 to 3 follow up visits at weekly intervals with lactation consultant~Lactation Consultant support: Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice."
10982126|NCT00966719|BG001|Baseline|Current Treatment for Jaundice|Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
10982127|NCT00966719|BG002|Baseline|Total|Total of all reporting groups
11007097|NCT01089504|BG002|Baseline|Total|Total of all reporting groups
10982128|NCT00966719|FG000|Participant Flow|Lactation Consultant|"In hospital meeting with lactation consultant~1 to 3 follow up visits at weekly intervals with lactation consultant~Lactation Consultant support: Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice."
10982129|NCT00966719|FG001|Participant Flow|Current Treatment for Jaundice|Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
10982130|NCT00966719|OG000|Outcome|Lactation Consultant|"In hospital meeting with lactation consultant~1 to 3 follow up visits at weekly intervals with lactation consultant~Lactation Consultant support: Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice."
10982131|NCT00966719|OG001|Outcome|Current Treatment for Jaundice|Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
10982132|NCT00966719|EG000|Reported Event|Lactation Consultant|"In hospital meeting with lactation consultant~1 to 3 follow up visits at weekly intervals with lactation consultant~Lactation Consultant support: Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice."
10982133|NCT00966719|EG001|Reported Event|Current Treatment for Jaundice|Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
10982134|NCT00966823|BG000|Baseline|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
10982135|NCT00966823|FG000|Participant Flow|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
10982136|NCT00966823|OG000|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
10982137|NCT00966823|EG000|Reported Event|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
10982138|NCT00966849|BG000|Baseline|Conditional Cash Transfer|"Conditional Cash Transfer: Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will only be given the cash if they comply with the following conditions:~An application for a birth certificate must be made for all children <18 years in the household who do not already have a birth certificate, including all newborn children within 3 months of birth.~All children <5 yrs in the household must be up-to-date with vaccinations~All children <5 yrs must attend a growth monitoring clinic twice per yr~All children 6-17 yrs in the household attended school at least 90% of days in the last month~At least one adult from each household attended at least 2/3 most recent parenting skills classes~Other procedures will be the same as in the unconditional cash transfer arm."
10982139|NCT00966849|BG001|Baseline|Unconditional Cash Transfer|"Vulnerable households in this arm will receive unconditional cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Unconditional Cash Transfers: Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will not be required to comply with conditions in order to receive the cash.~Standard Agricultural Package: A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.~Parenting Skills Classes: 2-3 parenting skills classes will be held annually in each study cluster."
10982140|NCT00966849|BG002|Baseline|Control|"Vulnerable households in this arm will not receive cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Standard Agricultural Package: A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.~Parenting Skills Classes: 2-3 parenting skills classes will be held annually in each study cluster."
10982141|NCT00966849|BG003|Baseline|Total|Total of all reporting groups
10982142|NCT00966849|FG000|Participant Flow|Conditional Cash Transfer|"Vulnerable households in this arm will receive conditional cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Conditional Cash Transfer: Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will only be given the cash if they comply with the following conditions:~An application for a birth certificate must be made for all children under 18 years in the household who do not already have a birth certificate, including all newborn children within 3 months of birth.~All children under 5 years in the household must be up-to-date with vaccinations.~All children under 5 years must attend a growth monitoring clinic twice per year.~All children 6-17 years in the household attended school"
11007098|NCT01089504|FG000|Participant Flow|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
11007099|NCT01089504|FG001|Participant Flow|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
11007100|NCT01089504|OG000|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
10982143|NCT00966849|FG001|Participant Flow|Unconditional Cash Transfer|"Vulnerable households in this arm will receive unconditional cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Unconditional Cash Transfers: Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will not be required to comply with conditions in order to receive the cash.~Standard Agricultural Package: A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.~Parenting Skills Classes: 2-3 parenting skills classes will be held annually in each study cluster."
10982144|NCT00966849|FG002|Participant Flow|Control|"Vulnerable households in this arm will not receive cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Standard Agricultural Package: A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.~Parenting Skills Classes: 2-3 parenting skills classes will be held annually in each study cluster."
10982145|NCT00966849|OG000|Outcome|Conditional Cash Transfer|"Conditional Cash Transfer: Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will only be given the cash if they comply with the following conditions:~An application for a birth certificate must be made for all children <18 years in the household who do not already have a birth certificate, including all newborn children within 3 months of birth.~All children <5 yrs in the household must be up-to-date with vaccinations~All children <5 yrs must attend a growth monitoring clinic twice per yr~All children 6-17 yrs in the household attended school at least 90% of days in the last month~At least one adult from each household attended at least 2/3 most recent parenting skills classes~Other procedures will be the same as in the unconditional cash transfer arm."
10982146|NCT00966849|OG001|Outcome|Unconditional Cash Transfer|"Vulnerable households in this arm will receive unconditional cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Unconditional Cash Transfers: Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will not be required to comply with conditions in order to receive the cash.~Standard Agricultural Package: A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.~Parenting Skills Classes: 2-3 parenting skills classes will be held annually in each study cluster."
10982147|NCT00966849|OG002|Outcome|Control|"Vulnerable households in this arm will not receive cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Standard Agricultural Package: A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.~Parenting Skills Classes: 2-3 parenting skills classes will be held annually in each study cluster."
10982148|NCT00966849|EG000|Reported Event|Conditional Cash Transfer|"Conditional Cash Transfer: Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will only be given the cash if they comply with the following conditions:~An application for a birth certificate must be made for all children under 18 years in the household who do not already have a birth certificate, including all newborn children within 3 months of birth.~All children under 5 years in the household must be up-to-date with vaccinations.~All children under 5 years must attend a growth monitoring clinic twice per year.~All children 6-17 years in the household attended school at least 90% of days in the last month.~At least one adult from each household attended at least 2 of the 3 most recent parenting skills classes.~Other procedures will be as described for the unconditional cash transfer arm."
10982149|NCT00966849|EG001|Reported Event|Unconditional Cash Transfer|"Vulnerable households in this arm will receive unconditional cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Unconditional Cash Transfers: Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will not be required to comply with conditions in order to receive the cash.~Standard Agricultural Package: A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.~Parenting Skills Classes: 2-3 parenting skills classes will be held annually in each study cluster."
10982150|NCT00966849|EG002|Reported Event|Control|"Vulnerable households in this arm will not receive cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.~Standard Agricultural Package: A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.~Parenting Skills Classes: 2-3 parenting skills classes will be held annually in each study cluster."
10982151|NCT00966875|BG000|Baseline|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982152|NCT00966875|BG001|Baseline|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982153|NCT00966875|BG002|Baseline|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982154|NCT00966875|BG003|Baseline|30 mg LY2439821 [bDMARD-naive Population|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982155|NCT00966875|BG004|Baseline|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982156|NCT00966875|BG005|Baseline|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982157|NCT00966875|BG006|Baseline|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982158|NCT00966875|BG007|Baseline|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982159|NCT00966875|BG008|Baseline|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982160|NCT00966875|BG009|Baseline|Total|Total of all reporting groups
10982161|NCT00966875|FG000|Participant Flow|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)]
10982162|NCT00966875|FG001|Participant Flow|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982163|NCT00966875|FG002|Participant Flow|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982164|NCT00966875|FG003|Participant Flow|30 mg LY2439821 [bDMARD-naive Population]|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982165|NCT00966875|FG004|Participant Flow|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982166|NCT00966875|FG005|Participant Flow|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982167|NCT00966875|FG006|Participant Flow|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)]
10982168|NCT00966875|FG007|Participant Flow|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982169|NCT00966875|FG008|Participant Flow|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982170|NCT00966875|OG000|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982171|NCT00966875|OG001|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982172|NCT00966875|OG002|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982173|NCT00966875|OG003|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982174|NCT00966875|OG004|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982175|NCT00966875|OG005|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982176|NCT00966875|OG000|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982177|NCT00966875|OG001|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982178|NCT00966875|OG002|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982179|NCT00966875|OG000|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982180|NCT00966875|OG000|Outcome|3 mg to 180 mg (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982181|NCT00966875|OG000|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982182|NCT00966875|OG006|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982183|NCT00966875|OG007|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982184|NCT00966875|OG008|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982185|NCT00966875|OG000|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982186|NCT00966875|OG001|Outcome|3 mg/160 mg LY2439821(bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982187|NCT00966875|OG002|Outcome|10 mg/160 mg LY2439821(bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982188|NCT00966875|OG003|Outcome|30 mg/160 mg LY2439821(bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982189|NCT00966875|OG004|Outcome|80 mg/160 mg LY2439821(bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982190|NCT00966875|OG005|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982191|NCT00966875|OG006|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982192|NCT00966875|OG007|Outcome|80 mg/160 mg LY2439821(TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982193|NCT00966875|OG008|Outcome|180 mg/160 mg LY2439821(TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982194|NCT00966875|OG000|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982195|NCT00966875|OG001|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982196|NCT00966875|OG002|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982197|NCT00966875|OG003|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982198|NCT00966875|OG004|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982199|NCT00966875|OG007|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982200|NCT00966875|OG008|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982201|NCT00966875|OG001|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 milligram (mg) LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982202|NCT00966875|OG006|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982203|NCT00966875|OG005|Outcome|180 mg LY2439821 (bDMARD-naive Population])|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982204|NCT00966875|OG002|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982205|NCT00966875|OG005|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982206|NCT00966875|OG004|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982207|NCT00966875|OG005|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982208|NCT00966875|OG006|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982209|NCT00966875|OG007|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982210|NCT00966875|OG008|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982211|NCT00966875|OG000|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982212|NCT00966875|OG001|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982213|NCT00966875|OG003|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982214|NCT00966875|OG005|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982215|NCT00966875|OG000|Outcome|Part A: 3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982216|NCT00966875|OG001|Outcome|Part A: 10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982217|NCT00966875|OG002|Outcome|Part A: 30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982218|NCT00966875|OG003|Outcome|Part A: 80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982219|NCT00966875|OG004|Outcome|Part A: 180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982220|NCT00966875|OG005|Outcome|Part A: 80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982221|NCT00966875|OG006|Outcome|Part A: 180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10982222|NCT00966875|OG007|Outcome|Part B: 160 mg LY2439821 (bDMARD-naive and TNFα-IR Population)|160 mg LY2439821 administered subcutaneously at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60, in Part B.
10982223|NCT00966875|EG000|Reported Event|3 mg LY2439821 (bDMARD-naive Population) Part A|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982224|NCT00966875|EG001|Reported Event|10 mg LY2439821 (bDMARD-naive Population) Part A|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982225|NCT00966875|EG002|Reported Event|30 mg LY2439821 (bDMARD-naive Population) Part A|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982226|NCT00966875|EG003|Reported Event|80 mg LY2439821 (bDMARD-naive Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982227|NCT00966875|EG004|Reported Event|180 mg LY2439821(bDMARD-naive Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982228|NCT00966875|EG005|Reported Event|Placebo (bDMARD-naive Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982229|NCT00966875|EG006|Reported Event|80 mg LY2439821 (TNFa-IR Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982230|NCT00966875|EG007|Reported Event|180 mg LY2439821 (TNFa-IR Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982231|NCT00966875|EG008|Reported Event|Placebo (TNFa-IR Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982232|NCT00966875|EG009|Reported Event|3 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982233|NCT00966875|EG010|Reported Event|10 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982234|NCT00966875|EG011|Reported Event|30 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982235|NCT00966875|EG012|Reported Event|80 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982236|NCT00966875|EG013|Reported Event|180 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982237|NCT00966875|EG014|Reported Event|Placebo/160 mg LY2439821 (bDMARD-naive Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982238|NCT00966875|EG015|Reported Event|80 mg/160 mg LY2439821 (TNFa-IR Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982239|NCT00966875|EG016|Reported Event|180 mg/160 mg LY2439821 (TNFa-IR Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
11007101|NCT01089504|OG001|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
10982240|NCT00966875|EG017|Reported Event|Placebo/160 mg LY2439821 (TNFa-IR Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10982241|NCT00966940|BG000|Baseline|Travoprost-to-tafluprost|Travoprost, then tafluprost
10982242|NCT00966940|BG001|Baseline|Tafluprost-to-travoprost|Tafluprost, then travoprost
10982243|NCT00966940|BG002|Baseline|Total|Total of all reporting groups
10982244|NCT00966940|FG000|Participant Flow|Travoprost-to-tafluprost|Travoprost, then tafluprost
10982245|NCT00966940|FG001|Participant Flow|Tafluprost-to-travoprost|Tafluprost, then travoprost
10982246|NCT00966940|OG000|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
10982247|NCT00966940|OG001|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
10982248|NCT00966940|EG000|Reported Event|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
10982249|NCT00966940|EG001|Reported Event|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
10982250|NCT00967005|BG000|Baseline|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
10982251|NCT00967005|BG001|Baseline|Sugar Pill|Sugar Pill: placebo control
10982252|NCT00967005|BG002|Baseline|Total|Total of all reporting groups
10982253|NCT00967005|FG000|Participant Flow|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
10982254|NCT00967005|FG001|Participant Flow|Sugar Pill|Sugar Pill: placebo control
10982255|NCT00967005|OG000|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
10982256|NCT00967005|OG001|Outcome|Sugar Pill|Sugar Pill: placebo control
10982257|NCT00967005|EG000|Reported Event|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
10982258|NCT00967005|EG001|Reported Event|Sugar Pill|Sugar Pill: placebo control
10982259|NCT00967018|BG000|Baseline|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
10982260|NCT00967018|FG000|Participant Flow|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
10982261|NCT00967018|OG000|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
10982262|NCT00967018|EG000|Reported Event|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
10982263|NCT00967044|BG000|Baseline|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by participants), three times per week.~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
10982264|NCT00967044|FG000|Participant Flow|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
10982265|NCT00967044|OG000|Outcome|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
11007102|NCT01089504|EG000|Reported Event|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
10982266|NCT00967044|EG000|Reported Event|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
10982267|NCT00967226|BG000|Baseline|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)"
10982268|NCT00967226|BG001|Baseline|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
10982269|NCT00967226|BG002|Baseline|Total|Total of all reporting groups
10982270|NCT00967226|FG000|Participant Flow|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~propranolol: propranolol 0.67 mg/kg p.o. TID 4-6 months"
10982271|NCT00967226|FG001|Participant Flow|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID 4-6 months"
10982272|NCT00967226|OG000|Outcome|Propranolol|A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)
10982273|NCT00967226|OG001|Outcome|Prednisolone|"A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months~Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
10982274|NCT00967226|OG000|Outcome|Overall Number of Adverse Events in Propranolol|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
10982275|NCT00967226|OG001|Outcome|Overall Number of Adverse Events in Prednisolone|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
10982276|NCT00967226|OG000|Outcome|Number of Serious Adverse Events in Propranolol|Serious adverse events in propranolol treated participants.
10982277|NCT00967226|OG001|Outcome|Number of Serious Adverse Events in Prednisolone|Serious adverse events in prednisolone treated participants
10982278|NCT00967226|OG000|Outcome|Growth/Developoment AEs Propranolol|Number of participants experiencing Growth/Development AEs
10982279|NCT00967226|OG001|Outcome|Growth/Development AEs Prednisolone|Number of participants experiencing Growth/Development AEs
10982280|NCT00967226|OG000|Outcome|Pulmonary/Respiratory AEs Propranolol|Number of participants experiencing pulmonary/respiratory AEs
10982281|NCT00967226|OG001|Outcome|Pulmonary/Respiratory AEs Prednisolone|Number of participants experiencing pulmonary/respiratory AEs
10982282|NCT00967226|OG000|Outcome|Allergy/Immunology Events Propranolol|Adverse events in allergy/immunology in propranolol treated participants
10982283|NCT00967226|OG001|Outcome|Allergy/Immunology Events Prednisolone|Adverse events in allergy/immunology in prednisolone treated participants
10982284|NCT00967226|OG000|Outcome|Dermatologic AEs Propranolol|Number of participants experiencing Dermatologic AEs
10982285|NCT00967226|OG001|Outcome|Dermatologic AEs Prednisolone|Number of participants experiencing Dermatologic AEs
10982286|NCT00967226|OG000|Outcome|Endocrine AEs Propranolol|Number of participants experiencing Endocrinologic AEs.
10982287|NCT00967226|OG001|Outcome|Endocrinologic AEs Prednisolone|Number of participants experiencing Endocrinologic AEs.
10982288|NCT00967226|OG000|Outcome|Gastrointestinal AEs Propranolol|Number of Participants experiencing Gastrointestinal AEs
10982289|NCT00967226|OG001|Outcome|Gastrointestinal AEs Prednisolone|Number of Participants experiencing Gastrointestinal AEs
10982290|NCT00967226|OG000|Outcome|Infectious AEs Propranolol|Number of participants experiencing Infectious AEs
10982291|NCT00967226|OG001|Outcome|Infectious AEs Prednisolone|Number of participants experiencing Infectious AEs
10982292|NCT00967226|OG000|Outcome|Metabolic/Laboratory AEs Propranolol|Number of participants experiencing Metabolic or Laboratory AEs.
10982293|NCT00967226|OG001|Outcome|Metabolic/Laboratory AEs Prednisolone|Number of participants experiencing Metabolic or Laboratory AEs in each study arm.
10982294|NCT00967226|OG000|Outcome|Vascular AEs Propranolol|Number of participants experiencing Vascular AEs
10982295|NCT00967226|OG001|Outcome|Vascular AEs Prednisolone|Number of participants experiencing Vascular AEs
10982296|NCT00967226|OG000|Outcome|Constitutional AEs Propranolol|Number of Participants experiencing Constitutional AEs
10982297|NCT00967226|OG001|Outcome|Constitutional AEs Prednisolone|Number of Participants experiencing Constitutional AEs
10982298|NCT00967226|EG000|Reported Event|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~propranolol: propranolol 0.5 mg/kg p.o. QID 6 months or less"
10982299|NCT00967226|EG001|Reported Event|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID x 6 months or less"
10982300|NCT00967330|BG000|Baseline|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
10982301|NCT00967330|BG001|Baseline|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
10982302|NCT00967330|BG002|Baseline|Total|Total of all reporting groups
10982303|NCT00967330|FG000|Participant Flow|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
10982304|NCT00967330|FG001|Participant Flow|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
10982305|NCT00967330|OG000|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
10982306|NCT00967330|OG001|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
10982307|NCT00967330|EG000|Reported Event|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
10982308|NCT00967330|EG001|Reported Event|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator or and, if eligible.
10982309|NCT00967343|BG000|Baseline|ATIR|Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
10982310|NCT00967343|FG000|Participant Flow|ATIR|Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
10982311|NCT00967343|OG000|Outcome|ATIR|Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
10982312|NCT00967343|EG000|Reported Event|ATIR|Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
10982313|NCT00967369|BG000|Baseline|BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)|Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
10982314|NCT00967369|BG001|Baseline|ICE (Ifosfamide, Carboplatin, Etoposide)|Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
10982315|NCT00967369|BG002|Baseline|Total|Total of all reporting groups
10982316|NCT00967369|FG000|Participant Flow|BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)|Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
10982317|NCT00967369|FG001|Participant Flow|ICE (Ifosfamide, Carboplatin, Etoposide)|Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
10982318|NCT00967369|OG000|Outcome|BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)|Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
10982319|NCT00967369|OG001|Outcome|ICE (Ifosfamide, Carboplatin, Etoposide)|Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
11098990|NCT01579084|EG007|Reported Event|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
10982320|NCT00967369|EG000|Reported Event|BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)|Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
10982321|NCT00967369|EG001|Reported Event|ICE (Ifosfamide, Carboplatin, Etoposide)|Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
10982322|NCT00967473|BG000|Baseline|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
10982323|NCT00967473|FG000|Participant Flow|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
10982324|NCT00967473|OG000|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
10982325|NCT00967473|EG000|Reported Event|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
10982326|NCT00967486|BG000|Baseline|Routine Shunt|routine methods of CEA
10982327|NCT00967486|BG001|Baseline|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
10982328|NCT00967486|BG002|Baseline|Total|Total of all reporting groups
10982329|NCT00967486|FG000|Participant Flow|Routine Shunt|Routine method of CEA
10982330|NCT00967486|FG001|Participant Flow|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
10982331|NCT00967486|OG000|Outcome|Routine Shunt|routine methods of CEA
10982332|NCT00967486|OG001|Outcome|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
10982333|NCT00967486|EG000|Reported Event|Routine Shunt|routine methods of CEA
10982334|NCT00967486|EG001|Reported Event|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
10982335|NCT00967499|BG000|Baseline|Palonosetron|Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
10982336|NCT00967499|BG001|Baseline|Ondansetron|Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
10982337|NCT00967499|BG002|Baseline|Total|Total of all reporting groups
10982338|NCT00967499|FG000|Participant Flow|Palonosetron|Participants received a single dose of palonosetron 0.075 milligram (mg), intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
10982339|NCT00967499|FG001|Participant Flow|Ondansetron|Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
10982340|NCT00967499|OG000|Outcome|Palonosetron|Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
10982341|NCT00967499|OG001|Outcome|Ondansetron|Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
10982342|NCT00967499|EG000|Reported Event|Palonosetron|Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
10982343|NCT00967499|EG001|Reported Event|Ondansetron|Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
11007103|NCT01089504|EG001|Reported Event|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
11007104|NCT01089517|BG000|Baseline|Lucentis|Sham/Lucentis 0.5 mg
11007105|NCT01089517|BG001|Baseline|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
11007106|NCT01089517|BG002|Baseline|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
11007107|NCT01089517|BG003|Baseline|Total|Total of all reporting groups
11007108|NCT01089517|FG000|Participant Flow|Lucentis|Sham/Lucentis 0.5 mg
11007109|NCT01089517|FG001|Participant Flow|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
11007110|NCT01089517|FG002|Participant Flow|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
11007111|NCT01089517|OG000|Outcome|Lucentis|Sham/Lucentis 0.5 mg
11007112|NCT01089517|OG001|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
11007113|NCT01089517|OG002|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
11007114|NCT01089517|EG000|Reported Event|Lucentis|Sham/Lucentis 0.5 mg
11007115|NCT01089517|EG001|Reported Event|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
11007116|NCT01089517|EG002|Reported Event|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
11007117|NCT01089543|BG000|Baseline|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
11007118|NCT01089543|BG001|Baseline|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
11007119|NCT01089543|BG002|Baseline|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
11007120|NCT01089543|BG003|Baseline|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
10982344|NCT00967551|BG000|Baseline|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
10982345|NCT00967551|BG001|Baseline|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
10982346|NCT00967551|BG002|Baseline|Total|Total of all reporting groups
10982347|NCT00967551|FG000|Participant Flow|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
10982348|NCT00967551|FG001|Participant Flow|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
10982349|NCT00967551|OG000|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
10982350|NCT00967551|OG001|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
10982351|NCT00967551|EG000|Reported Event|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
10982352|NCT00967551|EG001|Reported Event|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
10982353|NCT00967616|BG000|Baseline|FOLFIRI|"Participants who received irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). FOLFIRI was administered by intravenous (IV) injection once every 2 weeks. The FOLFIRI regimen consisted of:~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
10982354|NCT00967616|BG001|Baseline|CS7017 + FOLFIRI|"Participants who received CS7017 plus irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). Two CS-7017 tablets were administered PO BID every 12 hours. FOLFIRI was administered IV once every 2 weeks. The FOLFIRI regimen consisted of:~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
10982355|NCT00967616|BG002|Baseline|Total|Total of all reporting groups
10982356|NCT00967616|FG000|Participant Flow|FOLFIRI|"Participants who received irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). FOLFIRI was administered by intravenous (IV) injection once every 2 weeks. The FOLFIRI regimen consisted of:~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
10982357|NCT00967616|FG001|Participant Flow|CS7017 + FOLFIRI|"Participants who received CS7017 plus irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). Two CS-7017 tablets were administered PO BID every 12 hours. FOLFIRI was administered IV once every 2 weeks. The FOLFIRI regimen consisted of:~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
10982358|NCT00967616|OG000|Outcome|FOLFIRI|"Participants who received irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). FOLFIRI was administered by intravenous (IV) injection once every 2 weeks. The FOLFIRI regimen consisted of:~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
10982359|NCT00967616|OG001|Outcome|CS7017 + FOLFIRI|"Participants who received CS7017 plus irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). Two CS-7017 tablets were administered PO BID every 12 hours. FOLFIRI was administered IV once every 2 weeks. The FOLFIRI regimen consisted of:~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
10982360|NCT00967616|EG000|Reported Event|FOLFIRI|"Participants who received irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). FOLFIRI was administered by intravenous (IV) injection once every 2 weeks. The FOLFIRI regimen consisted of:~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
10982361|NCT00967616|EG001|Reported Event|CS7017 + FOLFIRI|"Participants who received CS7017 plus irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). Two CS-7017 tablets were administered PO BID every 12 hours. FOLFIRI was administered IV once every 2 weeks. The FOLFIRI regimen consisted of:~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
10982362|NCT00967668|BG000|Baseline|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
11007121|NCT01089543|BG004|Baseline|Total|Total of all reporting groups
11007122|NCT01089543|FG000|Participant Flow|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
11007123|NCT01089543|FG001|Participant Flow|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
11007124|NCT01089543|FG002|Participant Flow|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
10982363|NCT00967668|BG001|Baseline|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982364|NCT00967668|BG002|Baseline|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
10982365|NCT00967668|BG003|Baseline|Total|Total of all reporting groups
10982366|NCT00967668|FG000|Participant Flow|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982367|NCT00967668|FG001|Participant Flow|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982368|NCT00967668|FG002|Participant Flow|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
10982369|NCT00967668|OG000|Outcome|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982370|NCT00967668|OG001|Outcome|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982371|NCT00967668|OG002|Outcome|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
11007125|NCT01089543|FG003|Participant Flow|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
11007126|NCT01089543|OG000|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
11007127|NCT01089543|OG001|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
11007128|NCT01089543|OG002|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
11007129|NCT01089543|OG003|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
11007130|NCT01089543|EG000|Reported Event|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
10982372|NCT00967668|OG000|Outcome|Arm 1|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982373|NCT00967668|OG001|Outcome|Arm 2|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982374|NCT00967668|OG002|Outcome|Arm 3|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
10982375|NCT00967668|EG000|Reported Event|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982376|NCT00967668|EG001|Reported Event|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
10982377|NCT00967668|EG002|Reported Event|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
10982378|NCT00967694|BG000|Baseline|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
10982379|NCT00967694|FG000|Participant Flow|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
10982380|NCT00967694|OG000|Outcome|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline (prior to nitrous oxide administration) and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore one study arm, with each individual serving as their control for baseline (before nitrous oxide administration) and then intervention values of IOP measurement (during nitrous oxide administration), and then washout values of IOP (after breathing room air).
10982381|NCT00967694|EG000|Reported Event|Nitrous Oxide Administration|20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
10982382|NCT00967798|BG000|Baseline|Sitagliptin|Participants randomized to receive Sitagliptin
10982383|NCT00967798|BG001|Baseline|Placebo|Participants randomized to receive a placebo
10982384|NCT00967798|BG002|Baseline|Total|Total of all reporting groups
10982385|NCT00967798|FG000|Participant Flow|Sitagliptin|Participants randomized to receive Sitagliptin
10982386|NCT00967798|FG001|Participant Flow|Placebo|Participants randomized to receive a placebo
10982387|NCT00967798|OG000|Outcome|Sitagliptin|Participants randomized to receive Sitagliptin
10982388|NCT00967798|OG001|Outcome|Placebo|Participants randomized to receive a placebo
10982389|NCT00967798|EG000|Reported Event|Sitagliptin|Participants randomized to receive Sitagliptin
10982390|NCT00967798|EG001|Reported Event|Placebo|Participants randomized to receive a placebo
10982391|NCT00967941|BG000|Baseline|Ancef|Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982392|NCT00967941|BG001|Baseline|Daptomycin and Cefazolin|Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982393|NCT00967941|BG002|Baseline|Vancomycin and Cefazolin|Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982394|NCT00967941|BG003|Baseline|Total|Total of all reporting groups
10982395|NCT00967941|FG000|Participant Flow|Ancef|Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982396|NCT00967941|FG001|Participant Flow|Daptomycin and Cefazolin|Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982397|NCT00967941|FG002|Participant Flow|Vancomycin and Cefazolin|Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982398|NCT00967941|OG000|Outcome|Ancef|Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982399|NCT00967941|OG001|Outcome|Daptomycin and Cefazolin|Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982400|NCT00967941|OG002|Outcome|Vancomycin and Cefazolin|Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
10982401|NCT00967941|OG000|Outcome|Total Patients With Infection|Total number of patients who have infections in the study.
10982402|NCT00967941|OG001|Outcome|Patients Without Infection|Total number of patients who do not have any infections.
10982403|NCT00967941|EG000|Reported Event|All Patients|The adverse event was counted for all patients instead of groups. Ideally no unexpected adverse events. All were known risks in vascular procedures.
10982404|NCT00967993|BG000|Baseline|KRX-0502|All subjects in this group will receive treatment with KRX-0502, 1g ferric citrate containing approximately 210 mg of ferric iron
10982405|NCT00967993|FG000|Participant Flow|KRX-0502|"All patients initiated on study drug were started on a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients were titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels went below normal, there was a decrease in pills; if serum phosphorus levels went above normal, there was an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day was 12, or 12 g/day of ferric citrate."
10982406|NCT00967993|OG000|Outcome|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
10982407|NCT00967993|EG000|Reported Event|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
10982408|NCT00968019|BG000|Baseline|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
10982409|NCT00968019|FG000|Participant Flow|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
10982410|NCT00968019|OG000|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
10982411|NCT00968019|EG000|Reported Event|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
10982412|NCT00968032|BG000|Baseline|Nit-Occlud® PFO|
10982413|NCT00968032|FG000|Participant Flow|Nit-Occlud® PFO Implantation Group|Patients suffering from PFO and suitable for closure of the defect with the Nit-Occlud® PFO Closure Device
10982414|NCT00968032|OG000|Outcome|Nit-Occlud® PFO|
10982415|NCT00968032|EG000|Reported Event|Nit-Occlud® PFO|
10982416|NCT00968071|BG000|Baseline|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
10982417|NCT00968071|FG000|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
10982418|NCT00968071|OG000|Outcome|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
10982419|NCT00968071|EG000|Reported Event|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
10982420|NCT00968227|BG000|Baseline|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
10982421|NCT00968227|FG000|Participant Flow|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
10982422|NCT00968227|OG000|Outcome|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
10982423|NCT00968227|EG000|Reported Event|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
10982424|NCT00968253|BG000|Baseline|Phase I: RAD001 5 mg + Combination Chemo|RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982425|NCT00968253|BG001|Baseline|Phase I: RAD001 10 mg + Combination Chemo|RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982426|NCT00968253|BG002|Baseline|Phase II: MTD RAD001 + Combination Chemo|RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982427|NCT00968253|BG003|Baseline|Total|Total of all reporting groups
11007131|NCT01089543|EG001|Reported Event|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
11007132|NCT01089543|EG002|Reported Event|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
11007133|NCT01089543|EG003|Reported Event|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
11007134|NCT01089556|BG000|Baseline|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
10982428|NCT00968253|FG000|Participant Flow|Phase I: RAD001 5 mg + Combination Chemo|"Everolimus (RAD001) beginning oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.~Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher."
10982429|NCT00968253|FG001|Participant Flow|Phase I: RAD001 10 mg + Combination Chemo|"RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.~Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher."
10982430|NCT00968253|FG002|Participant Flow|Phase II: MTD RAD001 + Combination Chemo|"RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.~Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher."
10982431|NCT00968253|OG000|Outcome|Phase I: RAD001 5 mg + Combination Chemo|RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982432|NCT00968253|OG001|Outcome|Phase I: RAD001 10 mg + Combination Chemo|RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982433|NCT00968253|OG002|Outcome|Phase II: MTD RAD001 + Combination Chemo|"RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.~Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher."
10982434|NCT00968253|OG002|Outcome|Phase II: MTD RAD001 + Combination Chemo|RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982435|NCT00968253|EG000|Reported Event|Phase I: RAD001 5 mg + Combination Chemo|RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982436|NCT00968253|EG001|Reported Event|Phase I: RAD001 10 mg + Combination Chemo|RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982437|NCT00968253|EG002|Reported Event|Phase II: MTD RAD001 + Combination Chemo|RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
10982438|NCT00968344|BG000|Baseline|Leucine|"3-4 g Leucine added to daily meals during bed rest~Leucine: 3-4g Leucine added to daily meals"
10982439|NCT00968344|BG001|Baseline|Placebo|"3-4 g Alanine added to daily meals during bed rest~Alanine: Powered amino acid"
10982440|NCT00968344|BG002|Baseline|Total|Total of all reporting groups
10982441|NCT00968344|FG000|Participant Flow|Leucine|"3-4 g Leucine added to daily meals during bed rest~Leucine: crystalline amino acid"
10982442|NCT00968344|FG001|Participant Flow|Placebo|"3-4 g Alanine added to daily meals during bed rest~Alanine: crystalline amino acid"
10982443|NCT00968344|OG000|Outcome|Control Group|Subjects in the control group consumed a 3-4 g of alanine at each meal (an isonitrogenous control)
10982444|NCT00968344|OG001|Outcome|Leucine (Intervention) Group|Subjects in the leucine group consumed 3-4 g of leucine at each meal during bed rest.
10982445|NCT00968344|EG000|Reported Event|Leucine|Leucine: 3-4g Leucine added to daily meals
10982446|NCT00968344|EG001|Reported Event|Placebo|Alanine: Powered amino acid
10982447|NCT00968526|BG000|Baseline|GSK2340272A 2D Group|Healthy male or female adults, aged 18 to 60 years (18-60y) and above (>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10982448|NCT00968526|BG001|Baseline|GSK2340272A 1D Group|Healthy male or female adults, aged 18 to 60 years (18-60y) and above (>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10982449|NCT00968526|BG002|Baseline|Total|Total of all reporting groups
10982450|NCT00968526|FG000|Participant Flow|GSK2340272A 2D Group|Healthy male or female adults, aged 18 to 60 years (18-60y) and above (>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10982451|NCT00968526|FG001|Participant Flow|GSK2340272A 1D Group|Healthy male or female adults, aged 18 to 60 years (18-60y) and above (>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10982452|NCT00968526|OG000|Outcome|GSK2340272A 2D (18-60y) Sub-Group|Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10982453|NCT00968526|OG001|Outcome|GSK2340272A 2D (>60y) Sub-Group|Sub-Group of healthy male or female adults, above 60 years (>60y), who received two doses 2D of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10982454|NCT00968526|OG001|Outcome|GSK2340272A 2D (>60y) Sub-Group|Sub-Group of healthy male or female adults, above 60 years (>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Dat 21.
10982455|NCT00968526|OG001|Outcome|GSK2340272A 2D (>60y) Sub-Group|Sub-Group of healthy male or female adults, above 60 years (>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10982456|NCT00968526|OG002|Outcome|GSK2340272A 1D (18-60y) Sub-Group|Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10982457|NCT00968526|OG003|Outcome|GSK2340272A 1D (>60y) Sub-Group|Sub-Group of healthy male or female adults, aged above 60 years (>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10982458|NCT00968526|OG003|Outcome|GSK2340272A 1D (>60y) Sub-Group|Sub-Group of healthy male or female adults, above 60 years (>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10982459|NCT00968526|OG000|Outcome|GSK2340272A 1D (18-60y) Sub-Group|Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10982460|NCT00968526|OG001|Outcome|GSK2340272A 1D (>60y) Sub-Group|Sub-Group of healthy male or female adults, above 60 years (>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10982461|NCT00968526|OG000|Outcome|GSK2340272A 1D & 2D (18-60y) Sub-Group|Pooled group for healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) or two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10982462|NCT00968526|OG001|Outcome|GSK2340272A 1D & 2D (>60y) Sub-Group|Pooled group for healthy male or female adults, above 60 years (>60y), who received a single dose 1D or two doses 2D of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10982463|NCT00968526|EG000|Reported Event|GSK2340272A 1D Group|Healthy male or female adults, aged 18 to 60 years (18-60y) and above (>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10982464|NCT00968526|EG001|Reported Event|GSK2340272A 2D Group|Healthy male or female adults, aged 18 to 60 years (18-60y) and above (>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
10982465|NCT00968539|BG000|Baseline|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982466|NCT00968539|BG001|Baseline|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982467|NCT00968539|BG002|Baseline|Total|Total of all reporting groups
10982468|NCT00968539|FG000|Participant Flow|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982469|NCT00968539|FG001|Participant Flow|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982470|NCT00968539|OG000|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982471|NCT00968539|OG001|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982472|NCT00968539|OG000|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982473|NCT00968539|EG000|Reported Event|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982474|NCT00968539|EG001|Reported Event|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10982475|NCT00968617|BG000|Baseline|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
10982476|NCT00968617|FG000|Participant Flow|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
10982477|NCT00968617|OG000|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
10982478|NCT00968617|EG000|Reported Event|MK-2578|
10982479|NCT00968669|BG000|Baseline|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
10982480|NCT00968669|BG001|Baseline|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982481|NCT00968669|BG002|Baseline|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982482|NCT00968669|BG003|Baseline|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982483|NCT00968669|BG004|Baseline|Total|Total of all reporting groups
10982484|NCT00968669|FG000|Participant Flow|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
10982485|NCT00968669|FG001|Participant Flow|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982486|NCT00968669|FG002|Participant Flow|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982487|NCT00968669|FG003|Participant Flow|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982488|NCT00968669|OG000|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
10982489|NCT00968669|OG001|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982490|NCT00968669|OG002|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982491|NCT00968669|OG003|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982492|NCT00968669|EG000|Reported Event|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
10982493|NCT00968669|EG001|Reported Event|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982494|NCT00968669|EG002|Reported Event|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982495|NCT00968669|EG003|Reported Event|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
10982496|NCT00968708|BG000|Baseline|Placebo|Alogliptin placebo matching tablets, orally, once daily.
10982497|NCT00968708|BG001|Baseline|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
10982498|NCT00968708|BG002|Baseline|Total|Total of all reporting groups
10982499|NCT00968708|FG000|Participant Flow|Placebo|Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
10982500|NCT00968708|FG001|Participant Flow|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
10982501|NCT00968708|OG000|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
10982502|NCT00968708|OG001|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
10982503|NCT00968708|EG000|Reported Event|Placebo|Alogliptin placebo matching tablets, orally, once daily.
10982504|NCT00968708|EG001|Reported Event|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
10982505|NCT00968799|BG000|Baseline|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
10982506|NCT00968799|FG000|Participant Flow|HIPEC|"Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)~Tumor nodules are removed surgically. If necessary infested organs like colon are resected (=cytoreduction).~To destroy remaining tumor cells or invisible nodules the peritoneum is prefused with 42°C warm 25 mg/l cisplatin solution. Perfusion volume depends on body size (3 - 6 l).~If cisplatin amount exceeds the equivalent of 62.5 mg/m² body surface, cisplatin is dosed by body surface (62.5 mg/m²)(safety margin).~Perfusion is performed with the open or Coliseum technique for 90 min."
10982507|NCT00968799|OG000|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
10982508|NCT00968799|EG000|Reported Event|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
10982509|NCT00968812|BG000|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
10982510|NCT00968812|BG001|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
10982511|NCT00968812|BG002|Baseline|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
10982512|NCT00968812|BG003|Baseline|Total|Total of all reporting groups
10982513|NCT00968812|FG000|Participant Flow|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
10982514|NCT00968812|FG001|Participant Flow|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
10982515|NCT00968812|FG002|Participant Flow|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
10982516|NCT00968812|OG000|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
10982517|NCT00968812|OG001|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
10982518|NCT00968812|OG002|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
10982519|NCT00968812|EG000|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
10982520|NCT00968812|EG001|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
10982521|NCT00968812|EG002|Reported Event|Glimepiride: Baseline to Week 52|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
10982522|NCT00968812|EG003|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
10982523|NCT00968812|EG004|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
10982524|NCT00968812|EG005|Reported Event|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
10982525|NCT00968838|BG000|Baseline|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
10982526|NCT00968838|BG001|Baseline|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
10982527|NCT00968838|BG002|Baseline|Total|Total of all reporting groups
10982528|NCT00968838|FG000|Participant Flow|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
10982529|NCT00968838|FG001|Participant Flow|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
10982530|NCT00968838|OG000|Outcome|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
10982531|NCT00968838|OG001|Outcome|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
10982532|NCT00968838|EG000|Reported Event|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
10982533|NCT00968838|EG001|Reported Event|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
10982534|NCT00968890|BG000|Baseline|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
10982535|NCT00968890|BG001|Baseline|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
10982536|NCT00968890|BG002|Baseline|Total|Total of all reporting groups
10982537|NCT00968890|FG000|Participant Flow|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
10982538|NCT00968890|FG001|Participant Flow|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
11007135|NCT01089556|BG001|Baseline|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
11007136|NCT01089556|BG002|Baseline|Total|Total of all reporting groups
10982539|NCT00968890|OG000|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
10982540|NCT00968890|OG001|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
10982541|NCT00968890|EG000|Reported Event|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
10982542|NCT00968890|EG001|Reported Event|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
10982543|NCT00968968|BG000|Baseline|Lapatinib + Trastuzumab|Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
10982544|NCT00968968|BG001|Baseline|Trastuzumab|Trastuzumab iv 6 mg/kg once every 3 weeks
10982545|NCT00968968|BG002|Baseline|Total|Total of all reporting groups
10982546|NCT00968968|FG000|Participant Flow|Lapatinib + Trastuzumab|Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
10982547|NCT00968968|FG001|Participant Flow|Trastuzumab|Trastuzumab iv 6 mg/kg once every 3 weeks
10982548|NCT00968968|OG000|Outcome|Lapatinib + Trastuzumab|Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
10982549|NCT00968968|OG001|Outcome|Trastuzumab|Trastuzumab iv 6 mg/kg once every 3 weeks
10982550|NCT00968968|EG000|Reported Event|Lapatinib + Trastuzumab|Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
10982551|NCT00968968|EG001|Reported Event|Trastuzumab|Trastuzumab iv 6 mg/kg once every 3 weeks
10982552|NCT00968968|EG002|Reported Event|All Subjects|All Subjects
10982553|NCT00968981|BG000|Baseline|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
10982554|NCT00968981|BG001|Baseline|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
10982555|NCT00968981|BG002|Baseline|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
10982556|NCT00968981|BG003|Baseline|Total|Total of all reporting groups
10982557|NCT00968981|FG000|Participant Flow|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once daily (QD) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
10982558|NCT00968981|FG001|Participant Flow|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule three times weekly (TIW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
10982559|NCT00968981|FG002|Participant Flow|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once weekly (QW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
10982560|NCT00968981|OG000|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
10982561|NCT00968981|OG001|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
10982562|NCT00968981|OG002|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
10982563|NCT00968981|OG000|Outcome|GDC-0449 150 mg: All Participants|All participants received single dose of GDC-0449 150 mg capsule orally on Day 1.
10982564|NCT00968981|EG000|Reported Event|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
10982565|NCT00968981|EG001|Reported Event|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
10982566|NCT00968981|EG002|Reported Event|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
10982567|NCT00969124|BG000|Baseline|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
10982568|NCT00969124|FG000|Participant Flow|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
10982569|NCT00969124|OG000|Outcome|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
10982570|NCT00969124|OG000|Outcome|Third Eye Retroscope|"All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.~Third Eye Retroscope: Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy"
10982571|NCT00969124|EG000|Reported Event|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
10982572|NCT00969150|BG000|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
10982573|NCT00969150|BG001|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
10982574|NCT00969150|BG002|Baseline|Total|Total of all reporting groups
10982575|NCT00969150|FG000|Participant Flow|Placebo|Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks.
10982576|NCT00969150|FG001|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
10982577|NCT00969150|OG000|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
10982578|NCT00969150|OG001|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
10982579|NCT00969150|EG000|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
10982580|NCT00969150|EG001|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
10982581|NCT00969228|BG000|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
10982582|NCT00969228|BG001|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
10982583|NCT00969228|BG002|Baseline|Total|Total of all reporting groups
10982584|NCT00969228|FG000|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
10982585|NCT00969228|FG001|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
10982586|NCT00969228|OG000|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
10982587|NCT00969228|OG001|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
10982588|NCT00969228|EG000|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
10982589|NCT00969228|EG001|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
10982590|NCT00969280|BG000|Baseline|Standardized Acupuncture Group|"Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after de qi manipulation for the verum acupuncture group."
10982591|NCT00969280|BG001|Baseline|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
10982592|NCT00969280|BG002|Baseline|Total|Total of all reporting groups
10982593|NCT00969280|FG000|Participant Flow|Standardized Acupuncture Group|"Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after de qi manipulation for the verum acupuncture group."
10982594|NCT00969280|FG001|Participant Flow|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
10982595|NCT00969280|OG000|Outcome|Standardized Acupuncture Group|"Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after de qi manipulation for the verum acupuncture group."
10982596|NCT00969280|OG001|Outcome|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
10982597|NCT00969280|EG000|Reported Event|Standardized Acupuncture Group|"Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after de qi manipulation for the verum acupuncture group."
11007137|NCT01089556|FG000|Participant Flow|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
11007138|NCT01089556|FG001|Participant Flow|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
10874091|NCT00431067|OG000|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
10874092|NCT00431067|EG000|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
10874093|NCT00431132|BG000|Baseline|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
10874094|NCT00431132|FG000|Participant Flow|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
10874095|NCT00431132|OG000|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
10874096|NCT00431132|EG000|Reported Event|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
10874097|NCT00431184|BG000|Baseline|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
10874098|NCT00431184|BG001|Baseline|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
10874099|NCT00431184|BG002|Baseline|Total|Total of all reporting groups
10874100|NCT00431184|FG000|Participant Flow|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
10874101|NCT00431184|FG001|Participant Flow|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
10874102|NCT00431184|OG000|Outcome|Pentazocine|Subjects received 50mg of pentazocine
10874103|NCT00431184|OG001|Outcome|Lorazepam|Subjects received 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later
10874104|NCT00431184|OG000|Outcome|Pentazocine|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Pentazocine.
10874105|NCT00431184|OG001|Outcome|Lorazepam|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Lorazepam.
10874106|NCT00431184|EG000|Reported Event|Pentazocine|All subjects receive 50mg of pentazocine followed by a second dose of 50mg two hours later on either Day 1 or Day 2.
10874107|NCT00431184|EG001|Reported Event|Lorazepam|All subjects receive 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later on either Day 1 or Day 2.
10874108|NCT00431444|BG000|Baseline|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
10874109|NCT00431444|BG001|Baseline|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
10874110|NCT00431444|BG002|Baseline|Total|Total of all reporting groups
10874111|NCT00431444|FG000|Participant Flow|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
10874112|NCT00431444|FG001|Participant Flow|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
10874113|NCT00431444|OG000|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
10874114|NCT00431444|OG001|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
10874115|NCT00431444|EG000|Reported Event|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
10874116|NCT00431444|EG001|Reported Event|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
10874117|NCT00431496|BG000|Baseline|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
10874118|NCT00431496|FG000|Participant Flow|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL), unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase.
10874119|NCT00431496|OG000|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
10874120|NCT00431496|EG000|Reported Event|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
10874121|NCT00431626|BG000|Baseline|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
10874122|NCT00431626|BG001|Baseline|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
10874123|NCT00431626|BG002|Baseline|Total|Total of all reporting groups
10874124|NCT00431626|FG000|Participant Flow|Treatment|
10874125|NCT00431626|FG001|Participant Flow|Placebo|
10874126|NCT00431626|OG000|Outcome|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
10874127|NCT00431626|OG001|Outcome|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
10982598|NCT00969280|EG001|Reported Event|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
10982599|NCT00969332|BG000|Baseline|Omegaven|"0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.~Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday"
10982600|NCT00969332|FG000|Participant Flow|Omegaven|Omegaven, 0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
10982601|NCT00969332|OG000|Outcome|Omegaven|"0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.~Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday"
10982602|NCT00969332|OG000|Outcome|Omegaven|"0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.~Omegaven: 0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday"
10982603|NCT00969332|EG000|Reported Event|Omegaven|"0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.~Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday"
10982604|NCT00969436|BG000|Baseline|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
10982605|NCT00969436|BG001|Baseline|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
10982606|NCT00969436|BG002|Baseline|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
10982607|NCT00969436|BG003|Baseline|Total|Total of all reporting groups
10982608|NCT00969436|FG000|Participant Flow|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
10982609|NCT00969436|FG001|Participant Flow|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
10982610|NCT00969436|FG002|Participant Flow|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
10982611|NCT00969436|OG000|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
10982612|NCT00969436|OG001|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
10982613|NCT00969436|OG002|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
10982614|NCT00969436|EG000|Reported Event|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
10982615|NCT00969436|EG001|Reported Event|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
10982616|NCT00969436|EG002|Reported Event|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
10982617|NCT00969501|BG000|Baseline|EUFLEXXA|ACTIVE CONTROL
10982618|NCT00969501|FG000|Participant Flow|EUFLEXXA|All subjects received three injections (one each, in weeks 0 [baseline], 1, and 2 of high molecular weight hyaluronate (2.5 mL each) using standard injection techniques in the anterior or posterior approach. Sub- jects were evaluated at screening and baseline, and at weeks 1, 2, 6, 14, 26, and 27 (last evaluation by telephone).
10982619|NCT00969501|OG000|Outcome|EUFLEXXA|ACTIVE CONTROL
10982620|NCT00969501|EG000|Reported Event|EUFLEXXA|ACTIVE CONTROL
10982621|NCT00969540|BG000|Baseline|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the placebo mattress cover group for 14 days. After a 7 day washout, they will be entered into the active mattress cover group for 14 days.
10982622|NCT00969540|BG001|Baseline|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the active mattress cover group for 14 days. After a 7 day washout, they will be entered into the placebo mattress cover group for 14 days.
10982623|NCT00969540|BG002|Baseline|Total|Total of all reporting groups
10982624|NCT00969540|FG000|Participant Flow|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days.
10982625|NCT00969540|FG001|Participant Flow|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days.
10874128|NCT00431626|EG000|Reported Event|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
10874129|NCT00431626|EG001|Reported Event|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
10874130|NCT00431834|BG000|Baseline|Entire Cohort|All subjects enrolled and treated with the Cardioblate Surgical Ablation System
10874131|NCT00431834|FG000|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 3 subjects died, 7 subjects withdrew from the study, 2 subjects missed the endpoint visit, and 1 subject was lost to follow-up.
10874132|NCT00431834|OG000|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed a Holter assessment at 6 month follow-up.
10874133|NCT00431834|OG000|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed 6 month follow-up and had a 24-hour Holter assessment.
10874134|NCT00431834|OG000|Outcome|Cardioblate Surgical Ablation System|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.
10874135|NCT00431834|OG000|Outcome|Cardioblate Surgical Ablation System|
10874136|NCT00431834|EG000|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 4 subjects died, 8 subjects withdrew from the study, and 1 subject was lost to follow-up.
10874137|NCT00431847|BG000|Baseline|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
10874138|NCT00431847|BG001|Baseline|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
10874139|NCT00431847|BG002|Baseline|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
10874140|NCT00431847|BG003|Baseline|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
10874141|NCT00431847|BG004|Baseline|Total|Total of all reporting groups
10874142|NCT00431847|FG000|Participant Flow|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
10874143|NCT00431847|FG001|Participant Flow|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
10874144|NCT00431847|FG002|Participant Flow|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
10874145|NCT00431847|FG003|Participant Flow|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
10874146|NCT00431847|FG004|Participant Flow|Unknown Treatment Status|No patient data on exposure to Regional Anesthesia
10874147|NCT00431847|OG000|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
10874148|NCT00431847|OG001|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
10874149|NCT00431847|OG002|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
10874150|NCT00431847|OG003|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
10874151|NCT00431847|EG000|Reported Event|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
10874152|NCT00431847|EG001|Reported Event|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
10874153|NCT00431847|EG002|Reported Event|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
10874154|NCT00431847|EG003|Reported Event|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
10874155|NCT00431951|BG000|Baseline|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
10874156|NCT00431951|BG001|Baseline|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874157|NCT00431951|BG002|Baseline|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874158|NCT00431951|BG003|Baseline|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
10874159|NCT00431951|BG004|Baseline|Total|Total of all reporting groups
10874160|NCT00431951|FG000|Participant Flow|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
10982626|NCT00969540|OG000|Outcome|Mean CGI Pain Scores With Placebo Mattress Cover.|Mean Clinical Global Impression pain scores with placebo mattress cover.
10982627|NCT00969540|OG001|Outcome|Mean CGI Pain Scores With Active Mattress Cover.|Mean Clinical Global Impression pain scores with active mattress cover.
10982628|NCT00969540|OG002|Outcome|Mean CGI Sleep Scores With Placebo Mattress Cover.|Mean Clinical Global Impression sleep scores with placebo mattress cover.
10982629|NCT00969540|OG003|Outcome|Mean CGI Sleep Scores With Active Mattress Cover.|Mean Clinical Global Impression sleep scores with active mattress cover.
10982630|NCT00969540|OG000|Outcome|Nighttime Wake Time With Placebo Mattress Cover|Nighttime wake time after sleep onset with placebo mattress cover.
10982631|NCT00969540|OG001|Outcome|Nighttime Wake Time With Active Mattress Cover|Nighttime wake time after sleep onset with active mattress cover.
10982632|NCT00969540|OG000|Outcome|Total Sleep With Placebo Mattress Cover|Total sleep with placebo mattress cover (minutes).
10982633|NCT00969540|OG001|Outcome|Total Sleep With Active Mattress Cover|Total sleep with active mattress cover (minutes).
10982634|NCT00969540|OG000|Outcome|Nocturnal Awakenings With Placebo Mattress Cover|Number of nocturnal awakenings with placebo mattress cover.
10982635|NCT00969540|OG001|Outcome|Nocturnal Awakenings With Active Mattress Cover|Number of nocturnal awakenings with active mattress cover.
10982636|NCT00969540|OG000|Outcome|Sleep Efficiency With Placebo Mattress Cover|Sleep efficiency with placebo mattress cover.
10982637|NCT00969540|OG001|Outcome|Sleep Efficiency With Active Mattress Cover|Sleep efficiency with active mattress cover.
10982638|NCT00969540|OG000|Outcome|Sleep Latency With Placebo Mattress Cover|Sleep latency with placebo mattress cover (minutes).
10982639|NCT00969540|OG001|Outcome|Sleep Latency With Active Mattress Cover|Sleep latency with active mattress cover (minutes).
10982640|NCT00969540|EG000|Reported Event|Placebo Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the placebo mattress cover for 14 days, followed by the active mattress cover for 14 days after a 7 day wash out period.
10982641|NCT00969540|EG001|Reported Event|Active Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the active mattress cover for 14 days, followed by the placebo mattress cover for 14 days after a 7 day wash out period.
10982642|NCT00969553|BG000|Baseline|V100 D1|A single dose of 100 mg volasertib on Day 1 every 3-week course.
10982643|NCT00969553|BG001|Baseline|V200 D1|A single dose of 200 mg volasertib on Day 1 every 3-week course.
10982644|NCT00969553|BG002|Baseline|V250 D1|A single dose of 250 mg volasertib on Day 1 every 3-week course.
10982645|NCT00969553|BG003|Baseline|V300 D1|A single dose of 300 mg volasertib on Day 1 every 3-week course.
10982646|NCT00969553|BG004|Baseline|V350 D1|A single dose of 350 mg volasertib on Day 1 every 3-week course.
10982647|NCT00969553|BG005|Baseline|V50 D1, D8|A single dose of 50 mg volasertib on Day 1 and Day 8 every 3-week course.
10982648|NCT00969553|BG006|Baseline|V100 D1, D8|A single dose of 100 mg volasertib on Day 1 and Day 8 every 3-week course.
10982649|NCT00969553|BG007|Baseline|V150 D1, D8|A single dose of 150 mg volasertib on Day 1 and Day 8 every 3-week course.
10982650|NCT00969553|BG008|Baseline|V200 D1, D8|A single dose of 200 mg volasertib on Day 1 and Day 8 every 3-week course.
10982651|NCT00969553|BG009|Baseline|Total|Total of all reporting groups
10982652|NCT00969553|FG000|Participant Flow|V 100 mg D1|"A single dose of 100 milligram (mg) volasertib (V) on Day 1 every 3-week course. Volasertib was administered as a short infusion over 120 minutes (min) using an infusion pump.~Immediately following the infusion of volasertib, the infusion tubing was washed with 100 millilitre (mL) physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly intravenous (i.v.)."
10982653|NCT00969553|FG001|Participant Flow|V 200 mg D1|"A single dose of 200 mg volasertib on Day 1 every 3-week course. Volasertib was administered as a short infusion over 120 min using an infusion pump.~Immediately following the infusion of volasertib, the infusion tubing was washed with 100 mL physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly i.v."
10982654|NCT00969553|FG002|Participant Flow|V 250 mg D1|"A single dose of 250 mg volasertib on Day 1 every 3-week course. Volasertib was administered as a short infusion over 120 min using an infusion pump.~Immediately following the infusion of volasertib, the infusion tubing was washed with 100 mL physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly i.v."
10982655|NCT00969553|FG003|Participant Flow|V 300 mg D1|"A single dose of 300 mg volasertib on Day 1 every 3-week course. Volasertib was administered as a short infusion over 120 min using an infusion pump.~Immediately following the infusion of volasertib, the infusion tubing was washed with 100 mL physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly i.v."
10982656|NCT00969553|FG004|Participant Flow|V 350 mg D1|"A single dose of 350 mg volasertib on Day 1 every 3-week course. Volasertib was administered as a short infusion over 120 min using an infusion pump.~Immediately following the infusion of volasertib, the infusion tubing was washed with 100 mL physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly i.v."
10982657|NCT00969553|FG005|Participant Flow|V 50 mg D1, D8|A single dose of 50 mg volasertib on Day 1 and Day 8 every 3-week course. Volasertib was administered as a short infusion over 120 min using an infusion pump. Immediately following the infusion of volasertib, the infusion tubing was washed with 100 mL physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly i.v.
11007139|NCT01089556|FG002|Participant Flow|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
11098991|NCT01579084|EG008|Reported Event|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
10982658|NCT00969553|FG006|Participant Flow|V 100 mg D1, D8|A single dose of 100 mg volasertib on Day 1 and Day 8 every 3-week course. Volasertib was administered as a short infusion over 120 min using an infusion pump. Immediately following the infusion of volasertib, the infusion tubing was washed with 100 mL physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly i.v.
10982659|NCT00969553|FG007|Participant Flow|V 150 mg D1, D8|A single dose of 150 mg volasertib on Day 1 and Day 8 every 3-week course. Volasertib was administered as a short infusion over 120 min using an infusion pump. Immediately following the infusion of volasertib, the infusion tubing was washed with 100 mL physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly i.v.
10982660|NCT00969553|FG008|Participant Flow|V 200 mg D1, D8|A single dose of 200 mg volasertib on Day 1 and Day 8 every 3-week course. Volasertib was administered as a short infusion over 120 min using an infusion pump. Immediately following the infusion of volasertib, the infusion tubing was washed with 100 mL physiological sodium chloride (0.9% NaCl) solution for a maximum duration of 10 min volasertib was administered strictly i.v.
10982661|NCT00969553|OG000|Outcome|V100 D1|A single dose of 100 mg volasertib on Day 1 every 3-week course.
10982662|NCT00969553|OG001|Outcome|V200 D1|A single dose of 200 mg volasertib on Day 1 every 3-week course.
10982663|NCT00969553|OG002|Outcome|V250 D1|A single dose of 250 mg volasertib on Day 1 every 3-week course.
10982664|NCT00969553|OG003|Outcome|V300 D1|A single dose of 300 mg volasertib on Day 1 every 3-week course.
10982665|NCT00969553|OG004|Outcome|V350 D1|A single dose of 350 mg volasertib on Day 1 every 3-week course.
10982666|NCT00969553|OG005|Outcome|V50 D1, D8|A single dose of 50 mg volasertib on Day 1 and Day 8 every 3-week course.
10982667|NCT00969553|OG006|Outcome|V100 D1, D8|A single dose of 100 mg volasertib on Day 1 and Day 8 every 3-week course.
10982668|NCT00969553|OG007|Outcome|V150 D1, D8|A single dose of 150 mg volasertib on Day 1 and Day 8 every 3-week course.
10982669|NCT00969553|OG008|Outcome|V200 D1, D8|A single dose of 200 mg volasertib on Day 1 and Day 8 every 3-week course.
10982670|NCT00969553|OG000|Outcome|Volasertib D1 Schedule|A single dose of volasertib on Day 1 every 3-week course.
10982671|NCT00969553|OG001|Outcome|Volasertib D1 and D 8 Schedule|A single dose of volasertib on Day 1 and Day 8 every 3-week course.
10982672|NCT00969553|OG000|Outcome|V300 D1|A single dose of 300 mg volasertib on Day 1 every 3-week course.
10982673|NCT00969553|OG001|Outcome|V150 D1, D8|A single dose of 150 mg volasertib on Day 1 and Day 8 every 3-week course.
10982674|NCT00969553|OG000|Outcome|V50 D1, D8|A single dose of 50 mg volasertib on Day 1 and Day 8 every 3-week course.
10982675|NCT00969553|OG001|Outcome|V100 D1, D8|A single dose of 100 mg volasertib on Day 1 and Day 8 every 3-week course.
10982676|NCT00969553|OG002|Outcome|V150 D1, D8|A single dose of 150 mg volasertib on Day 1 and Day 8 every 3-week course.
10982677|NCT00969553|OG003|Outcome|V200 D1, D8|A single dose of 200 mg volasertib on Day 1 and Day 8 every 3-week course.
10982678|NCT00969553|EG000|Reported Event|V100 D1|A single dose of 100 mg volasertib on Day 1 every 3-week course.
10982679|NCT00969553|EG001|Reported Event|V200 D1|A single dose of 200 mg volasertib on Day 1 every 3-week course.
10982680|NCT00969553|EG002|Reported Event|V250 D1|A single dose of 250 mg volasertib on Day 1 every 3-week course.
10982681|NCT00969553|EG003|Reported Event|V300 D1|A single dose of 300 mg volasertib on Day 1 every 3-week course.
10982682|NCT00969553|EG004|Reported Event|V350 D1|A single dose of 350 mg volasertib on Day 1 every 3-week course.
10982683|NCT00969553|EG005|Reported Event|V50 D1, D8|A single dose of 50 mg volasertib on Day 1 and Day 8 every 3-week course.
10982684|NCT00969553|EG006|Reported Event|V100 D1, D8|A single dose of 100 mg volasertib on Day 1 and Day 8 every 3-week course.
10982685|NCT00969553|EG007|Reported Event|V150 D1, D8|A single dose of 150 mg volasertib on Day 1 and Day 8 every 3-week course.
10982686|NCT00969553|EG008|Reported Event|V200 D1, D8|A single dose of 200 mg volasertib on Day 1 and Day 8 every 3-week course.
10982687|NCT00969618|BG000|Baseline|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
10982688|NCT00969618|FG000|Participant Flow|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
10982689|NCT00969618|OG000|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
10982690|NCT00969618|EG000|Reported Event|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
10982691|NCT00969709|BG000|Baseline|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
10982692|NCT00969709|BG001|Baseline|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
10982693|NCT00969709|BG002|Baseline|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
10982694|NCT00969709|BG003|Baseline|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
10982695|NCT00969709|BG004|Baseline|Total|Total of all reporting groups
10982696|NCT00969709|FG000|Participant Flow|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
10982697|NCT00969709|FG001|Participant Flow|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.~Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
10982698|NCT00969709|FG002|Participant Flow|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing~Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
10982699|NCT00969709|FG003|Participant Flow|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing~Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
10982700|NCT00969709|OG000|Outcome|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
10982701|NCT00969709|OG001|Outcome|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.~Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
10874161|NCT00431951|FG001|Participant Flow|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874162|NCT00431951|FG002|Participant Flow|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874163|NCT00431951|FG003|Participant Flow|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
10874164|NCT00431951|OG000|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
10874165|NCT00431951|OG001|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
10874166|NCT00431951|OG002|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
10874167|NCT00431951|OG003|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
10874168|NCT00431951|OG000|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874169|NCT00431951|OG001|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874170|NCT00431951|OG002|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874171|NCT00431951|OG003|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
10874172|NCT00431951|EG000|Reported Event|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
10874173|NCT00431951|EG001|Reported Event|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874174|NCT00431951|EG002|Reported Event|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
10874175|NCT00431951|EG003|Reported Event|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
10874176|NCT00431964|BG000|Baseline|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
10874177|NCT00431964|BG001|Baseline|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
10874178|NCT00431964|BG002|Baseline|Total|Total of all reporting groups
10874179|NCT00431964|FG000|Participant Flow|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
10874180|NCT00431964|FG001|Participant Flow|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
10874181|NCT00431964|OG000|Outcome|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
10874182|NCT00431964|OG001|Outcome|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
10874183|NCT00431964|EG000|Reported Event|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
10874184|NCT00431964|EG001|Reported Event|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
10879340|NCT00457197|FG001|Participant Flow|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
10879341|NCT00457197|OG000|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
10879342|NCT00457197|OG001|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
10879343|NCT00457197|EG000|Reported Event|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
10982702|NCT00969709|OG002|Outcome|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing~Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
10874185|NCT00432042|BG000|Baseline|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874186|NCT00432042|BG001|Baseline|Arm 2: ProQuad®|Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874187|NCT00432042|BG002|Baseline|Arm 3: Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874188|NCT00432042|BG003|Baseline|Total|Total of all reporting groups
10874189|NCT00432042|FG000|Participant Flow|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874190|NCT00432042|FG001|Participant Flow|Arm 2: ProQuad®|Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874191|NCT00432042|FG002|Participant Flow|Arm 3: Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874192|NCT00432042|OG000|Outcome|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874193|NCT00432042|OG001|Outcome|Arm 2: ProQuad®|Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874194|NCT00432042|OG001|Outcome|Arm 3: Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874195|NCT00432042|EG000|Reported Event|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874196|NCT00432042|EG001|Reported Event|Arm 2: ProQuad®|Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874197|NCT00432042|EG002|Reported Event|Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
10874198|NCT00432159|BG000|Baseline|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874199|NCT00432159|BG001|Baseline|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
10874200|NCT00432159|BG002|Baseline|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874201|NCT00432159|BG003|Baseline|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
10874202|NCT00432159|BG004|Baseline|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874203|NCT00432159|BG005|Baseline|Total|Total of all reporting groups
10874204|NCT00432159|FG000|Participant Flow|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874205|NCT00432159|FG001|Participant Flow|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
10874206|NCT00432159|FG002|Participant Flow|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874207|NCT00432159|FG003|Participant Flow|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
10874208|NCT00432159|FG004|Participant Flow|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874209|NCT00432159|OG000|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874210|NCT00432159|OG001|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
10874211|NCT00432159|OG002|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874212|NCT00432159|OG003|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
10874213|NCT00432159|OG004|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874214|NCT00432159|EG000|Reported Event|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874215|NCT00432159|EG001|Reported Event|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
10874216|NCT00432159|EG002|Reported Event|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874217|NCT00432159|EG003|Reported Event|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
10874218|NCT00432159|EG004|Reported Event|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
10874219|NCT00432172|BG000|Baseline|Group 1 (Luminal A) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874220|NCT00432172|BG001|Baseline|Group 1 (Luminal A) Selective Treatment|Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months
10874221|NCT00432172|BG002|Baseline|Group 2 (Basal) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874222|NCT00432172|BG003|Baseline|Group 2 (Basal) Selective Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
10874223|NCT00432172|BG004|Baseline|Total|Total of all reporting groups
10874224|NCT00432172|FG000|Participant Flow|Group 1 (Luminal A) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874225|NCT00432172|FG001|Participant Flow|Group 1 (Luminal A) Selective Treatment|Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months
10874226|NCT00432172|FG002|Participant Flow|Group 2 (Basal) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874227|NCT00432172|FG003|Participant Flow|Group 2 (Basal) Selective Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
10874228|NCT00432172|OG000|Outcome|Group 2 (Basal) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874229|NCT00432172|OG001|Outcome|Group 2 (Basal) Selective Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
10874230|NCT00432172|OG000|Outcome|Group 1 (Luminal A) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874231|NCT00432172|OG001|Outcome|Group 1 (Luminal A) Selective Treatment|Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months
10874232|NCT00432172|OG002|Outcome|Group 2 (Basal) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874233|NCT00432172|OG003|Outcome|Group 2 (Basal) Selective Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
10874234|NCT00432172|EG000|Reported Event|Group 1 (Luminal A) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874235|NCT00432172|EG001|Reported Event|Group 1 (Luminal A) Selective Treatment|Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months
11098992|NCT01579084|EG009|Reported Event|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
10874236|NCT00432172|EG002|Reported Event|Group 2 (Basal) Standard Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
10874237|NCT00432172|EG003|Reported Event|Group 2 (Basal) Selective Treatment|Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
10874238|NCT00432237|BG000|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
10874239|NCT00432237|BG001|Baseline|MK0974 150 mg|"MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
10874240|NCT00432237|BG002|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
10874241|NCT00432237|BG003|Baseline|Placebo|"Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
10874242|NCT00432237|BG004|Baseline|Total|Total of all reporting groups
10874243|NCT00432237|FG000|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
10874244|NCT00432237|FG001|Participant Flow|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
10874245|NCT00432237|FG002|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
10874246|NCT00432237|FG003|Participant Flow|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
10874247|NCT00432237|OG000|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
10874248|NCT00432237|OG001|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
10874249|NCT00432237|OG002|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
10874250|NCT00432237|OG003|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
10874251|NCT00432237|EG000|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
10874252|NCT00432237|EG001|Reported Event|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
10874253|NCT00432237|EG002|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
10874254|NCT00432237|EG003|Reported Event|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
10874255|NCT00432276|BG000|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
10874256|NCT00432276|BG001|Baseline|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
10874257|NCT00432276|BG002|Baseline|Total|Total of all reporting groups
10874258|NCT00432276|FG000|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
10874259|NCT00432276|FG001|Participant Flow|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
10874260|NCT00432276|OG000|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
10874261|NCT00432276|OG001|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
10874262|NCT00432276|EG000|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
10874263|NCT00432276|EG001|Reported Event|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
10874264|NCT00432341|BG000|Baseline|BOTOX®|Botulinum toxin type A (BOTOX®)
10874265|NCT00432341|BG001|Baseline|Dysport®|Botulinum toxin type A (Dysport®)
10874266|NCT00432341|BG002|Baseline|Total|Total of all reporting groups
10874267|NCT00432341|FG000|Participant Flow|BOTOX®|Botulinum toxin type A (BOTOX®)
10874268|NCT00432341|FG001|Participant Flow|Dysport®|Botulinum toxin type A (Dysport®)
10874269|NCT00432341|OG000|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
10874270|NCT00432341|OG001|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
10874271|NCT00432341|EG000|Reported Event|BOTOX®|Botulinum toxin type A (BOTOX®)
10874272|NCT00432341|EG001|Reported Event|Dysport®|Botulinum toxin type A (Dysport®)
10874273|NCT00432380|BG000|Baseline|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874274|NCT00432380|BG001|Baseline|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874275|NCT00432380|BG002|Baseline|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874276|NCT00432380|BG003|Baseline|Total|Total of all reporting groups
10874277|NCT00432380|FG000|Participant Flow|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874278|NCT00432380|FG001|Participant Flow|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874279|NCT00432380|FG002|Participant Flow|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874280|NCT00432380|OG000|Outcome|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874281|NCT00432380|OG000|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874282|NCT00432380|OG001|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874283|NCT00432380|OG002|Outcome|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874284|NCT00432380|EG000|Reported Event|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874285|NCT00432380|EG001|Reported Event|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874286|NCT00432380|EG002|Reported Event|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
10874287|NCT00432458|BG000|Baseline|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
10874288|NCT00432458|BG001|Baseline|Arm II: ZLD|Zoledronic acid (ZLD)
10874289|NCT00432458|BG002|Baseline|Total|Total of all reporting groups
10874290|NCT00432458|FG000|Participant Flow|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
10874291|NCT00432458|FG001|Participant Flow|Arm II: ZLD|Zoledronic acid (ZLD)
10874292|NCT00432458|OG000|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
10874293|NCT00432458|OG001|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
10874294|NCT00432458|EG000|Reported Event|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
10874295|NCT00432458|EG001|Reported Event|Arm II: ZLD|Zoledronic acid (ZLD)
10874296|NCT00432562|BG000|Baseline|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
10874297|NCT00432562|BG001|Baseline|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
10874298|NCT00432562|BG002|Baseline|Total|Total of all reporting groups
10874299|NCT00432562|FG000|Participant Flow|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
10982703|NCT00969709|OG003|Outcome|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing~Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
10874300|NCT00432562|FG001|Participant Flow|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
10874301|NCT00432562|OG000|Outcome|ANX-530|
10874302|NCT00432562|OG001|Outcome|Navelbine|
10874303|NCT00432562|EG000|Reported Event|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
10874304|NCT00432562|EG001|Reported Event|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
10874305|NCT00432601|BG000|Baseline|Arm 1|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
10874306|NCT00432601|BG001|Baseline|Arm 2|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
10874307|NCT00432601|BG002|Baseline|Total|Total of all reporting groups
10874308|NCT00432601|FG000|Participant Flow|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
10874309|NCT00432601|FG001|Participant Flow|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
10874310|NCT00432601|OG000|Outcome|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
10874311|NCT00432601|OG001|Outcome|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
10874312|NCT00432601|EG000|Reported Event|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
10874313|NCT00432601|EG001|Reported Event|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
10874314|NCT00432666|BG000|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
10874315|NCT00432666|BG001|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
10874316|NCT00432666|BG002|Baseline|Total|Total of all reporting groups
10874317|NCT00432666|FG000|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
10874318|NCT00432666|FG001|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
10874319|NCT00432666|OG000|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
10874320|NCT00432666|OG001|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
10874321|NCT00432666|EG000|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
10874322|NCT00432666|EG001|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
10874323|NCT00432679|BG000|Baseline|Rosiglitazone 4 mg Orally Once Daily|Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
10874324|NCT00432679|BG001|Baseline|Placebo|Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
10874325|NCT00432679|BG002|Baseline|Total|Total of all reporting groups
10874326|NCT00432679|FG000|Participant Flow|Rosiglitazone 4 mg Orally Once Daily|Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 milligrams (mg) tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
10874327|NCT00432679|FG001|Participant Flow|Placebo|Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
10874328|NCT00432679|OG000|Outcome|Rosiglitazone 4 mg Orally Once Daily|Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
10874329|NCT00432679|OG001|Outcome|Placebo|Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
10874330|NCT00432679|EG000|Reported Event|Rosiglitazone 4 mg Orally Once Daily|Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
10874331|NCT00432679|EG001|Reported Event|Placebo|Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
10874332|NCT00432744|BG000|Baseline|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
10874333|NCT00432744|BG001|Baseline|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
10874334|NCT00432744|BG002|Baseline|Total|Total of all reporting groups
10874335|NCT00432744|FG000|Participant Flow|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
10874336|NCT00432744|FG001|Participant Flow|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
10874337|NCT00432744|OG000|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
10874338|NCT00432744|OG001|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
10874339|NCT00432744|EG000|Reported Event|CoenzymeQ10|CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed. (Either in Period 1 or Period 2)
10874340|NCT00432744|EG001|Reported Event|Placebo|Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group. (Either in Period 1 or Period 2)
10874341|NCT00432809|BG000|Baseline|Medical Therapy|Intensive medical therapy for diabetes
10874342|NCT00432809|BG001|Baseline|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
10874343|NCT00432809|BG002|Baseline|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
10874344|NCT00432809|BG003|Baseline|Total|Total of all reporting groups
10874345|NCT00432809|FG000|Participant Flow|Medical Therapy|Intensive medical therapy for diabetes
10874346|NCT00432809|FG001|Participant Flow|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
10874347|NCT00432809|FG002|Participant Flow|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
10874348|NCT00432809|OG000|Outcome|Medical Therapy|Intensive medical therapy for diabetes
10874349|NCT00432809|OG001|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
10874350|NCT00432809|OG002|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
10874351|NCT00432809|EG000|Reported Event|Medical Therapy|Intensive medical therapy for diabetes
10874352|NCT00432809|EG001|Reported Event|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
10874353|NCT00432809|EG002|Reported Event|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
10874354|NCT00432835|BG000|Baseline|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
10874355|NCT00432835|BG001|Baseline|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
10874356|NCT00432835|BG002|Baseline|Total|Total of all reporting groups
10874357|NCT00432835|FG000|Participant Flow|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
10874358|NCT00432835|FG001|Participant Flow|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
10874359|NCT00432835|OG000|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
10874360|NCT00432835|OG001|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
10874361|NCT00432835|EG000|Reported Event|Gastric Stimactivated|Gastric Electrical Stimulation
10874362|NCT00432835|EG001|Reported Event|Gastric StimulationNotActivated|Sham stimulation
10874363|NCT00432965|BG000|Baseline|VAC Therapy|"Treatment of Diabetic Foot Ulcers with VAC Therapy~VAC Therapy: VAC Therapy"
10874364|NCT00432965|BG001|Baseline|Moist Wound Therapy|"Moist Wound Therapy (standard of care)~Moist Wound Therapy: Moist Wound Therapy (Standard of Care)"
10874365|NCT00432965|BG002|Baseline|Total|Total of all reporting groups
10874366|NCT00432965|FG000|Participant Flow|VAC Therapy|"Treatment of Diabetic Foot Ulcers with VAC Therapy~VAC Therapy: VAC Therapy"
10874367|NCT00432965|FG001|Participant Flow|Moist Wound Therapy|"Moist Wound Therapy (standard of care)~Moist Wound Therapy: Moist Wound Therapy (Standard of Care)"
10874368|NCT00432965|OG000|Outcome|VAC Therapy|"Treatment of Diabetic Foot Ulcers with VAC Therapy~VAC Therapy: VAC Therapy"
10874369|NCT00432965|OG001|Outcome|Moist Wound Therapy|"Moist Wound Therapy (standard of care)~Moist Wound Therapy: Moist Wound Therapy (Standard of Care)"
10874370|NCT00432965|EG000|Reported Event|VAC Therapy|"Treatment of Diabetic Foot Ulcers with VAC Therapy~VAC Therapy: VAC Therapy"
10874371|NCT00432965|EG001|Reported Event|Moist Wound Therapy|"Moist Wound Therapy (standard of care)~Moist Wound Therapy: Moist Wound Therapy (Standard of Care)"
10874372|NCT00432991|BG000|Baseline|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
10874373|NCT00432991|BG001|Baseline|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
10874374|NCT00432991|BG002|Baseline|Total|Total of all reporting groups
10874375|NCT00432991|FG000|Participant Flow|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
10874376|NCT00432991|FG001|Participant Flow|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
10874377|NCT00432991|OG000|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
10874378|NCT00432991|OG001|Outcome|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
10874379|NCT00432991|EG000|Reported Event|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
10874380|NCT00432991|EG001|Reported Event|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
10874381|NCT00433004|BG000|Baseline|No Advance EC|No advance supply of emergency contraception
10874382|NCT00433004|BG001|Baseline|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): Postpartum TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRAPCETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
10874383|NCT00433004|BG002|Baseline|Total|Total of all reporting groups
10874384|NCT00433004|FG000|Participant Flow|No Advance EC|No advance supply of emergency contraception
10874385|NCT00433004|FG001|Participant Flow|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
10874386|NCT00433004|OG000|Outcome|No Advance EC|No advance supply of emergency contraception
10874387|NCT00433004|OG001|Outcome|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
10874388|NCT00433004|EG000|Reported Event|No Advance EC|No advance supply of emergency contraception
10874389|NCT00433004|EG001|Reported Event|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
10879344|NCT00457197|EG001|Reported Event|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
10874390|NCT00433017|BG000|Baseline|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
10874391|NCT00433017|BG001|Baseline|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
10874392|NCT00433017|BG002|Baseline|Total|Total of all reporting groups
10874393|NCT00433017|FG000|Participant Flow|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
10874394|NCT00433017|FG001|Participant Flow|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
10874395|NCT00433017|OG000|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
10874396|NCT00433017|OG001|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
10874397|NCT00433017|EG000|Reported Event|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
10874398|NCT00433017|EG001|Reported Event|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
10874399|NCT00433147|BG000|Baseline|Afegostat Tartrate 25 mg Once Per Day|Afegostat tartrate was administered orally during the 4-week treatment period.
10874400|NCT00433147|BG001|Baseline|Afegostat Tartrate 150 mg Once Per Day|Afegostat tartrate was administered orally once per day during the 4-week treatment period.
10874401|NCT00433147|BG002|Baseline|Afegostat Tartrate 150 mg Once Every Four Days|Afegostat tartrate was administered orally once every 4 days during the 4-week treatment period.
10874402|NCT00433147|BG003|Baseline|Afegostat Tartrate 150 mg Once Every Seven Days|Afegostat tartrate was administered orally once every 7 days during the 4-week treatment period.
10874403|NCT00433147|BG004|Baseline|Total|Total of all reporting groups
10874404|NCT00433147|FG000|Participant Flow|Afegostat Tartrate 25 Milligrams (mg) Once Per Day|Afegostat tartrate was administered orally during the 4-week treatment period.
10874405|NCT00433147|FG001|Participant Flow|Afegostat Tartrate 150 mg Once Per Day|Afegostat tartrate was administered orally once per day during the 4-week treatment period.
10879345|NCT00457249|BG000|Baseline|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
10874406|NCT00433147|FG002|Participant Flow|Afegostat Tartrate 150 mg Once Every Four Days|Afegostat tartrate was administered orally once every 4 days during the 4-week treatment period.
10874407|NCT00433147|FG003|Participant Flow|Afegostat Tartrate 150 mg Once Every Seven Days|Afegostat tartrate was administered orally once every 7 days during the 4-week treatment period.
10874408|NCT00433147|OG000|Outcome|Afegostat Tartrate 25 mg Once Per Day|Afegostat tartrate was administered orally during the 4-week treatment period.
10874409|NCT00433147|OG001|Outcome|Afegostat Tartrate 150 mg Once Per Day|Afegostat tartrate was administered orally once per day during the 4-week treatment period.
10874410|NCT00433147|OG002|Outcome|Afegostat Tartrate 150 mg Once Every Four Days|Afegostat tartrate was administered orally once every 4 days during the 4-week treatment period.
10874411|NCT00433147|OG003|Outcome|Afegostat Tartrate 150 mg Once Every Seven Days|Afegostat tartrate was administered orally once every 7 days during the 4-week treatment period.
10874412|NCT00433147|EG000|Reported Event|Afegostat Tartrate 25 mg Once Per Day|Afegostat tartrate was administered orally during the 4-week treatment period.
10874413|NCT00433147|EG001|Reported Event|Afegostat Tartrate 150 mg Once Per Day|Afegostat tartrate was administered orally once per day during the 4-week treatment period.
10874414|NCT00433147|EG002|Reported Event|Afegostat Tartrate 150 mg Once Every Four Days|Afegostat tartrate was administered orally once every 4 days during the 4-week treatment period.
10874415|NCT00433147|EG003|Reported Event|Afegostat Tartrate 150 mg Once Every Seven Days|Afegostat tartrate was administered orally once every 7 days during the 4-week treatment period.
10874416|NCT00433160|BG000|Baseline|Teriparatide|20 micrograms for 104 weeks
10874417|NCT00433160|BG001|Baseline|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
10874418|NCT00433160|BG002|Baseline|Total|Total of all reporting groups
10874419|NCT00433160|FG000|Participant Flow|Teriparatide|20 micrograms for 104 weeks
10874420|NCT00433160|FG001|Participant Flow|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
10874421|NCT00433160|OG000|Outcome|Teriparatide|20 micrograms for 104 weeks
10874422|NCT00433160|OG001|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
10874423|NCT00433160|EG000|Reported Event|Teriparatide (During 52 Weeks)|20 micrograms for 104 weeks
10874424|NCT00433160|EG001|Reported Event|Placebo (During 52 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
10874425|NCT00433160|EG002|Reported Event|Teriparatide (During 76 Weeks)|20 micrograms for 104 weeks
10874426|NCT00433160|EG003|Reported Event|Placebo (During 76 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
10874427|NCT00433160|EG004|Reported Event|Teriparatide (During 104 Weeks)|20 micrograms for 104 weeks
10874428|NCT00433160|EG005|Reported Event|Placebo (During 104 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
10874429|NCT00433199|BG000|Baseline|Placebo|Placebo comparator administered during the Double-Blind period only
10874430|NCT00433199|BG001|Baseline|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
10874431|NCT00433199|BG002|Baseline|Total|Total of all reporting groups
10874432|NCT00433199|FG000|Participant Flow|Placebo|Placebo comparator administered during the Double-Blind period only
10874433|NCT00433199|FG001|Participant Flow|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
10874434|NCT00433199|OG000|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
10874435|NCT00433199|OG001|Outcome|Placebo|Placebo Comparator given during the double-blind period.
10874436|NCT00433199|OG000|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
10874437|NCT00433199|OG001|Outcome|Formerly Placebo (FP)|Placebo group given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
10874438|NCT00433199|OG002|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
10874439|NCT00433199|OG000|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
10874440|NCT00433199|OG001|Outcome|Formerly Placebo (FP)|Placebo given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
10874441|NCT00433199|EG000|Reported Event|Placebo|Placebo comparator administered during the Double-Blind period only
10874442|NCT00433199|EG001|Reported Event|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
10874443|NCT00433290|BG000|Baseline|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
10874444|NCT00433290|BG001|Baseline|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
10874445|NCT00433290|BG002|Baseline|Total|Total of all reporting groups
10874446|NCT00433290|FG000|Participant Flow|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
10874447|NCT00433290|FG001|Participant Flow|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
10874448|NCT00433290|OG000|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
10874449|NCT00433290|OG001|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
10874450|NCT00433290|EG000|Reported Event|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
10874451|NCT00433290|EG001|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
10874452|NCT00433329|BG000|Baseline|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
10874453|NCT00433329|FG000|Participant Flow|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
10874454|NCT00433329|OG000|Outcome|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
10874455|NCT00433329|EG000|Reported Event|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
10874456|NCT00433381|BG000|Baseline|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
10874457|NCT00433381|BG001|Baseline|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
10874458|NCT00433381|BG002|Baseline|Total|Total of all reporting groups
10874459|NCT00433381|FG000|Participant Flow|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
10874460|NCT00433381|FG001|Participant Flow|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
10874461|NCT00433381|OG000|Outcome|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
10874462|NCT00433381|OG000|Outcome|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
10874463|NCT00433381|OG000|Outcome|Analyzable MRS Participants|The subset of 13 participants from any arm with analyzable MRS datasets from the group of 20 who consented to the MRS substudy.
10874464|NCT00433381|OG000|Outcome|Analyzable MRS Participants|The subset of 13 participants with analyzable MRS datasets from the 20 who consented to the MRS substudy
10874465|NCT00433381|OG001|Outcome|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
10874466|NCT00433381|OG000|Outcome|Standard MRI Local and Central Evaluation|103 cases with both a central and local interpretation of the standard MRI
10874467|NCT00433381|OG000|Outcome|No Particpants|This is a NULL group set to represent a population of 0 participants.
10874468|NCT00433381|OG000|Outcome|DSC 2-week Participants|The subset of 13 participants with a baseline and 2-week DSC MRI, from the group of 21 participants with analyzable DSC scans, defined as having both the baseline scan and at least one post-baseline scan that produced usable DSC data
10874469|NCT00433381|OG000|Outcome|DSC 8-week Participants|The subset of 17 participants with a baseline and 8-week DSC MRI, from the group of 21 participants with analyzable DSC scans, defined as having both the baseline scan and at least one post-baseline scan that produced usable DSC data
10874470|NCT00433381|OG000|Outcome|DSC 16-week Participants|The subset of 13 participants with a baseline and 16-week DSC MRI, from the group of 21 participants with analyzable DSC scans, defined as having both the baseline scan and at least one post-baseline scan that produced usable DSC data
10874471|NCT00433381|EG000|Reported Event|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 60.
10874472|NCT00433381|EG001|Reported Event|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 57 patients.
10874473|NCT00433446|BG000|Baseline|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
10874474|NCT00433446|FG000|Participant Flow|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
10874475|NCT00433446|OG000|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
10874476|NCT00433446|EG000|Reported Event|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
10874477|NCT00433537|BG000|Baseline|Step 1 - VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
10879346|NCT00457249|BG001|Baseline|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
10879347|NCT00457249|BG002|Baseline|Total|Total of all reporting groups
10879348|NCT00457249|FG000|Participant Flow|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
10879349|NCT00457249|FG001|Participant Flow|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
10879350|NCT00457249|OG000|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
10874478|NCT00433537|FG000|Participant Flow|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneous (SC) or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
10874479|NCT00433537|FG001|Participant Flow|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
10874480|NCT00433537|FG002|Participant Flow|VcR-CVAD Induction Then Off Study|Patients received VcR-CVAD induction but did not proceed to step 2 treatment for various reasons.
10874481|NCT00433537|OG000|Outcome|VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
10874482|NCT00433537|OG000|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
10874483|NCT00433537|OG001|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
10874484|NCT00433537|EG000|Reported Event|Step 1 - VcR-CVAD Induction|All patients who received VcR-CVAD induction.
10874485|NCT00433537|EG001|Reported Event|Step 2 - Maintenance Rituximab|All patients who received maintenance rituximab.
10874486|NCT00433550|BG000|Baseline|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
10874487|NCT00433550|BG001|Baseline|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
10874488|NCT00433550|BG002|Baseline|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
10874489|NCT00433550|BG003|Baseline|Total|Total of all reporting groups
10874490|NCT00433550|FG000|Participant Flow|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
10874491|NCT00433550|FG001|Participant Flow|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
10874492|NCT00433550|FG002|Participant Flow|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
10874493|NCT00433550|OG000|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype):~Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15~Group 2 (6/7 UGT1A1 genotype):~Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15.~Group 3 (7/7 UGT1A1 genotype):~Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
10879351|NCT00457249|OG001|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
10879352|NCT00457249|OG000|Outcome|Adacel® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
10879353|NCT00457249|OG001|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
10879354|NCT00457249|EG000|Reported Event|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
10874494|NCT00433550|OG000|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype):> Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15> > Group 2 (6/7 UGT1A1 genotype):> Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15.>~> Group 3 (7/7 UGT1A1 genotype):> Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
10874495|NCT00433550|OG000|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype):~> Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15~>~>~Group 2 (6/7 UGT1A1 genotype):~> Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15.~>~>~Group 3 (7/7 UGT1A1 genotype):~> Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
10874496|NCT00433550|EG000|Reported Event|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
10874497|NCT00433550|EG001|Reported Event|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
10874498|NCT00433550|EG002|Reported Event|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
10874499|NCT00433654|BG000|Baseline|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
10874500|NCT00433654|BG001|Baseline|Control Group|The control group waited for one hour (did not have an MRI scan) at 9-12 weeks post-implant.
10874501|NCT00433654|BG002|Baseline|Total|Total of all reporting groups
10874502|NCT00433654|FG000|Participant Flow|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
10874503|NCT00433654|FG001|Participant Flow|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
10874504|NCT00433654|OG000|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
10874505|NCT00433654|OG001|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
10874506|NCT00433654|OG001|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
10874507|NCT00433654|OG001|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
10874508|NCT00433654|OG000|Outcome|Implanted Subjects|All subjects undergoing an implant attempt
10874509|NCT00433654|OG000|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
10874510|NCT00433654|OG000|Outcome|5086 MRI Lead|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
10874511|NCT00433654|EG000|Reported Event|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
10874512|NCT00433654|EG001|Reported Event|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
10874513|NCT00433654|EG002|Reported Event|Non-randomized|Some subjects were enrolled, but either did not receive a system, or received only a partial system, and were not randomized. Their adverse events were collected until they exited the study.
10874514|NCT00433745|BG000|Baseline|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
10874515|NCT00433745|FG000|Participant Flow|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
10874516|NCT00433745|OG000|Outcome|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
10874517|NCT00433745|OG000|Outcome|WT1 Peptide Vaccine|"All 4 patients who were accrued went on to receive the vaccine.~Complete Response (CR): defined as an absolute neutrophil count of ≥500/µL, platelet count of ≥75,000/µL, no leukemic blasts in the blood nor evidence of extramedullary leukemia, bone marrow (BM) with a cellularity of more than 20%, maturation of all three cell lineages, no Auer rods, and less than 5% bone marrow blast cells.~Partial response (PR): 50% reduction in marrow blasts, with an absolute neutrophil count (ANC) greater than 500/µL, and platelet count greater than 75000/µL.~No response: subjects who did not meet the above response criteria were defined as non-responders."
10874518|NCT00433745|EG000|Reported Event|WT1 Peptide Vaccine|All 4 patients who were accrued went on to receive the vaccine
10874519|NCT00433771|BG000|Baseline|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
10874520|NCT00433771|FG000|Participant Flow|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
10874521|NCT00433771|OG000|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
10874522|NCT00433771|EG000|Reported Event|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
10874523|NCT00433836|BG000|Baseline|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
10874524|NCT00433836|BG001|Baseline|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
10874525|NCT00433836|BG002|Baseline|Total|Total of all reporting groups
10874526|NCT00433836|FG000|Participant Flow|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
10874527|NCT00433836|FG001|Participant Flow|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
10874528|NCT00433836|OG000|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
10874529|NCT00433836|OG001|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
10848650|NCT00290771|BG000|Baseline|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
10848651|NCT00290771|BG001|Baseline|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
10848652|NCT00290771|BG002|Baseline|Total|Total of all reporting groups
10848653|NCT00290771|FG000|Participant Flow|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
10848654|NCT00290771|FG001|Participant Flow|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
10848655|NCT00290771|OG000|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
10848656|NCT00290771|OG001|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
10848657|NCT00290771|OG002|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
10848658|NCT00290771|EG000|Reported Event|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
10848659|NCT00290771|EG001|Reported Event|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
10848660|NCT00290810|BG000|Baseline|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10848661|NCT00290810|FG000|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10848662|NCT00290810|OG000|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10848663|NCT00290810|EG000|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10848888|NCT00292318|BG001|Baseline|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
10848889|NCT00292318|BG002|Baseline|Total|Total of all reporting groups
10848890|NCT00292318|FG000|Participant Flow|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
10848891|NCT00292318|FG001|Participant Flow|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
10848892|NCT00292318|OG000|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
10982704|NCT00969709|OG000|Outcome|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
10982705|NCT00969709|OG001|Outcome|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
10982706|NCT00969709|OG002|Outcome|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
10982707|NCT00969709|OG003|Outcome|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
10982708|NCT00969709|EG000|Reported Event|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks.
10982709|NCT00969709|EG001|Reported Event|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER, low dose, oral administration, once daily for 8 weeks.
10982710|NCT00969709|EG002|Reported Event|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
10982711|NCT00969709|EG003|Reported Event|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
10982712|NCT00969761|BG000|Baseline|V200+Cis75|Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982713|NCT00969761|BG001|Baseline|V300+Cis75|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982714|NCT00969761|BG002|Baseline|V300+Cis100|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982715|NCT00969761|BG003|Baseline|V350+Cis75|Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982716|NCT00969761|BG004|Baseline|V100+Car4|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982717|NCT00969761|BG005|Baseline|V100+Car5|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982718|NCT00969761|BG006|Baseline|V200+Car5|Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982719|NCT00969761|BG007|Baseline|V300+Car5|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982720|NCT00969761|BG008|Baseline|V300+Car6|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982721|NCT00969761|BG009|Baseline|V350+Car5|Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982722|NCT00969761|BG010|Baseline|V100+Cis60|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982723|NCT00969761|BG011|Baseline|V100+Cis75|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982724|NCT00969761|BG012|Baseline|Total|Total of all reporting groups
10982725|NCT00969761|FG000|Participant Flow|V200+Cis75|Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982726|NCT00969761|FG001|Participant Flow|V300+Cis75|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982727|NCT00969761|FG002|Participant Flow|V300+Cis100|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982728|NCT00969761|FG003|Participant Flow|V350+Cis75|Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982729|NCT00969761|FG004|Participant Flow|V100+Car4|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982730|NCT00969761|FG005|Participant Flow|V100+Car5|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982731|NCT00969761|FG006|Participant Flow|V200+Car5|Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982732|NCT00969761|FG007|Participant Flow|V300+Car5|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10874530|NCT00433836|EG000|Reported Event|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
10874531|NCT00433836|EG001|Reported Event|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
10874532|NCT00433914|BG000|Baseline|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
10874533|NCT00433914|BG001|Baseline|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
10874534|NCT00433914|BG002|Baseline|Total|Total of all reporting groups
10874535|NCT00433914|FG000|Participant Flow|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
10874536|NCT00433914|FG001|Participant Flow|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
10874537|NCT00433914|OG000|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
10874538|NCT00433914|OG001|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
10874539|NCT00433914|EG000|Reported Event|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
10874540|NCT00433914|EG001|Reported Event|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
10874541|NCT00433966|BG000|Baseline|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
10874542|NCT00433966|BG001|Baseline|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
10874543|NCT00433966|BG002|Baseline|Total|Total of all reporting groups
10874544|NCT00433966|FG000|Participant Flow|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
10874545|NCT00433966|FG001|Participant Flow|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
10874546|NCT00433966|FG002|Participant Flow|Stent Arm - Paclitaxel-Eluting Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
10874547|NCT00433966|FG003|Participant Flow|Stent Arm - Bare Metal Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
10879355|NCT00457249|EG001|Reported Event|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
10879356|NCT00457301|BG000|Baseline|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
10879357|NCT00457301|BG001|Baseline|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
10879358|NCT00457301|BG002|Baseline|Total|Total of all reporting groups
10982733|NCT00969761|FG008|Participant Flow|V300+Car6|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982734|NCT00969761|FG009|Participant Flow|V350+Car5|Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982735|NCT00969761|FG010|Participant Flow|V100+Cis60|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982736|NCT00969761|FG011|Participant Flow|V100+Cis75|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982737|NCT00969761|OG000|Outcome|V100+Cis60|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982738|NCT00969761|OG001|Outcome|V100+Cis75|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982739|NCT00969761|OG002|Outcome|V200+Cis75|Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982740|NCT00969761|OG003|Outcome|V300+Cis75|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982741|NCT00969761|OG004|Outcome|V300+Cis100|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982742|NCT00969761|OG005|Outcome|V350+Cis75|Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982743|NCT00969761|OG006|Outcome|V100+Car4|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982744|NCT00969761|OG007|Outcome|V100+Car5|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982745|NCT00969761|OG008|Outcome|V200+Car5|Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982746|NCT00969761|OG009|Outcome|V300+Car5|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982747|NCT00969761|OG010|Outcome|V300+Car6|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10848664|NCT00290888|BG000|Baseline|Arthroscopic Rotator Cuff Repair Without Acromioplasty|Arthroscopic rotator cuff repair without acromioplasty (ACR)
10982748|NCT00969761|OG011|Outcome|V350+Car5|Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982749|NCT00969761|EG000|Reported Event|V200+Cis75|Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982750|NCT00969761|EG001|Reported Event|V300+Cis75|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982751|NCT00969761|EG002|Reported Event|V300+Cis100|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982752|NCT00969761|EG003|Reported Event|V350+Cis75|Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982753|NCT00969761|EG004|Reported Event|V100+Car4|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982754|NCT00969761|EG005|Reported Event|V100+Car5|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982755|NCT00969761|EG006|Reported Event|V200+Car5|Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
11007140|NCT01089556|FG003|Participant Flow|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
10982756|NCT00969761|EG007|Reported Event|V300+Car5|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982757|NCT00969761|EG008|Reported Event|V300+Car6|Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982758|NCT00969761|EG009|Reported Event|V350+Car5|Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982759|NCT00969761|EG010|Reported Event|V100+Cis60|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982760|NCT00969761|EG011|Reported Event|V100+Cis75|Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
10982761|NCT00969878|BG000|Baseline|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
10982762|NCT00969878|BG001|Baseline|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
10982763|NCT00969878|BG002|Baseline|Total|Total of all reporting groups
10982764|NCT00969878|FG000|Participant Flow|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
10982765|NCT00969878|FG001|Participant Flow|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
10982766|NCT00969878|OG000|Outcome|Placebo Injection|A saline injection to mimic the active medication is administered to the Placebo group.
10982767|NCT00969878|OG001|Outcome|TA-CD Vaccination|The group randomized to receive the active medication, received the actual TA-CD vaccination at preset intervals as specified in the approved protocol.
10982768|NCT00969878|OG000|Outcome|Placebo Injection|Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
10982769|NCT00969878|OG001|Outcome|TA-CD Vaccination|Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
10982770|NCT00969878|EG000|Reported Event|Placebo Injection|Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
10982771|NCT00969878|EG001|Reported Event|TA-CD Vaccination|Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
10982772|NCT00970073|BG000|Baseline|Delayed CNI Group 1|"Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)~Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180"
10848665|NCT00290888|BG001|Baseline|Arthroscopic Rotator Cuff Repair With Acromioplasty|Arthroscopic rotator cuff repair with acromioplasty (ACR-A)
10848666|NCT00290888|BG002|Baseline|Total|Total of all reporting groups
10982773|NCT00970073|BG001|Baseline|Delayed CNI Group 2|"Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)~Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180"
11007141|NCT01089556|FG004|Participant Flow|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
11007142|NCT01089556|FG005|Participant Flow|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
10982774|NCT00970073|BG002|Baseline|Early CNI / Control Arm|"Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180."
10982775|NCT00970073|BG003|Baseline|Total|Total of all reporting groups
10982776|NCT00970073|FG000|Participant Flow|Delayed CNI Group 1|"Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)~Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180"
10982777|NCT00970073|FG001|Participant Flow|Delayed CNI Group 2|"Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)~Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180"
10982778|NCT00970073|FG002|Participant Flow|Early CNI / Control Arm|"Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180."
10982779|NCT00970073|OG000|Outcome|Delayed CNI Group 1|"Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)~Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180"
10982780|NCT00970073|OG001|Outcome|Delayed CNI Group 2|"Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)~Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180"
10982781|NCT00970073|OG002|Outcome|Early CNI / Control Arm|"Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180."
10982782|NCT00970073|EG000|Reported Event|Delayed CNI Group 1|"Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)~Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180"
10982783|NCT00970073|EG001|Reported Event|Delayed CNI Group 2|"Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)~Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180"
10982784|NCT00970073|EG002|Reported Event|Early CNI / Control Arm|"Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).~Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months~tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180."
10982785|NCT00970203|BG000|Baseline|Cohort A|"3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine~AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells~androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg~DC1 vaccine: 3-5 x 10e6 cells total"
10982786|NCT00970203|BG001|Baseline|Cohort B|"3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation~AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells~androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg~DC1 vaccine: 3-5 x 10e6 cells total"
10982787|NCT00970203|BG002|Baseline|Total|Total of all reporting groups
10982788|NCT00970203|FG000|Participant Flow|Cohort A|"3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine~AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells~androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg~DC1 vaccine: 3-5 x 10e6 cells total"
10848667|NCT00290888|FG000|Participant Flow|Arthroscopic Rotator Cuff Repair Without Acromioplasty|"ACR~Acromioplasty"
10982789|NCT00970203|FG001|Participant Flow|Cohort B|"3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation~AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells~androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg~DC1 vaccine: 3-5 x 10e6 cells total"
10874548|NCT00433966|OG000|Outcome|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
10874549|NCT00433966|OG001|Outcome|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
10874550|NCT00433966|OG000|Outcome|Stent Arm - Paclitaxel-Eluting Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
10874551|NCT00433966|OG001|Outcome|Stent Arm - Bare Metal Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
10874552|NCT00433966|EG000|Reported Event|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
10874553|NCT00433966|EG001|Reported Event|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
10874554|NCT00433966|EG002|Reported Event|Stent Arm - Paclitaxel-Eluting Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
10874555|NCT00433966|EG003|Reported Event|Stent Arm - Bare Metal Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
10874556|NCT00433992|BG000|Baseline|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
10874557|NCT00433992|BG001|Baseline|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
10874558|NCT00433992|BG002|Baseline|Total|Total of all reporting groups
10874559|NCT00433992|FG000|Participant Flow|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
10874560|NCT00433992|FG001|Participant Flow|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
10874561|NCT00433992|OG000|Outcome|ABC/3TC+EFV|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) with Efavirenz at baseline
10874562|NCT00433992|OG001|Outcome|TDF/FTC+EFV|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with Efavirenz at baseline
10874563|NCT00433992|OG002|Outcome|ATV/r +TDF/FTC|HIV infected subjects taking atazanavir-ritonavir with tenofovir DF-emtricitabine at baseline
10874564|NCT00433992|OG003|Outcome|ATV/r +ABC/3TC|HIV-infected subjects taking atazanavir-ritonavir with abacavir-lamivudine at baseline
10874565|NCT00433992|OG000|Outcome|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
10874566|NCT00433992|OG001|Outcome|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
10982790|NCT00970203|OG000|Outcome|Cohort A|"3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine~AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells~androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg~DC1 vaccine: 3-5 x 10e6 cells total"
10982791|NCT00970203|OG001|Outcome|Cohort B|"3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation~AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells~androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg~DC1 vaccine: 3-5 x 10e6 cells total"
10982792|NCT00970203|EG000|Reported Event|Cohort A|"3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine~AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells~androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg~DC1 vaccine: 3-5 x 10e6 cells total"
10982793|NCT00970203|EG001|Reported Event|Cohort B|"3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation~AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells~androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg~DC1 vaccine: 3-5 x 10e6 cells total"
10982794|NCT00970216|BG000|Baseline|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
10982795|NCT00970216|FG000|Participant Flow|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
10982796|NCT00970216|OG000|Outcome|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
10982797|NCT00970216|EG000|Reported Event|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
10982798|NCT00970268|BG000|Baseline|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10982799|NCT00970268|BG001|Baseline|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10982800|NCT00970268|BG002|Baseline|Total|Total of all reporting groups
10982801|NCT00970268|FG000|Participant Flow|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10982802|NCT00970268|FG001|Participant Flow|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10982803|NCT00970268|OG000|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
10982804|NCT00970268|OG001|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
10982805|NCT00970268|OG002|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation, twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
10982806|NCT00970268|OG003|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 microgram of Aclidinium bromide for 12 weeks in the lead-in study.
10982807|NCT00970268|OG002|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
10982808|NCT00970268|OG003|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
10982809|NCT00970268|EG000|Reported Event|Placebo to Aclidinium Bromide 200 μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment
10982810|NCT00970268|EG001|Reported Event|Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg|Patients were given 12 weeks of Aclidinium bromide, 200 microgram dose, then continued with the 200 microgram dose, oral inhalation twice per day for an additional 52 weeks of treatment.
10982811|NCT00970268|EG002|Reported Event|Placebo to Aclidinium Bromide 400μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment
10982812|NCT00970268|EG003|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Patients were given 12 weeks of Aclidinium bromide, 400 microgram dose, then continued with the 400 microgram dose twice per day, oral inhalation, for an additional 52 weeks of treatment.
10982813|NCT00970281|BG000|Baseline|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
10982814|NCT00970281|BG001|Baseline|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
10982815|NCT00970281|BG002|Baseline|Total|Total of all reporting groups
10982816|NCT00970281|FG000|Participant Flow|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
10982817|NCT00970281|FG001|Participant Flow|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
10982818|NCT00970281|OG000|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
10982819|NCT00970281|OG001|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
10982820|NCT00970281|EG000|Reported Event|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
10848668|NCT00290888|FG001|Participant Flow|Arthorscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
10848669|NCT00290888|OG000|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
10874567|NCT00433992|EG000|Reported Event|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
10874568|NCT00433992|EG001|Reported Event|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
10874569|NCT00434018|BG000|Baseline|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
10874570|NCT00434018|BG001|Baseline|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
10874571|NCT00434018|BG002|Baseline|Total|Total of all reporting groups
10874572|NCT00434018|FG000|Participant Flow|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
10874573|NCT00434018|FG001|Participant Flow|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
10874574|NCT00434018|OG000|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
10874575|NCT00434018|OG001|Outcome|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
10874576|NCT00434018|OG001|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
10874577|NCT00434018|EG000|Reported Event|Wheelchair Skills Training|Wheelchair Skills Training: Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
10874578|NCT00434018|EG001|Reported Event|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
10874579|NCT00434057|BG000|Baseline|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
10874580|NCT00434057|FG000|Participant Flow|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
10874581|NCT00434057|OG000|Outcome|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
10874582|NCT00434057|EG000|Reported Event|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
10874583|NCT00434109|BG000|Baseline|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
10874584|NCT00434109|FG000|Participant Flow|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
10874585|NCT00434109|OG000|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
10874586|NCT00434109|EG000|Reported Event|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
10874587|NCT00434122|BG000|Baseline|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
10874588|NCT00434122|BG001|Baseline|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
10874589|NCT00434122|BG002|Baseline|Total|Total of all reporting groups
10874590|NCT00434122|FG000|Participant Flow|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
10874591|NCT00434122|FG001|Participant Flow|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
10874592|NCT00434122|OG000|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
10874593|NCT00434122|OG001|Outcome|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
10874594|NCT00434122|OG001|Outcome|Degarelix Follicular, 2.5 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6
10874595|NCT00434122|OG002|Outcome|Ganirelix, 0.25 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
10982821|NCT00970281|EG001|Reported Event|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
10982822|NCT00970294|BG000|Baseline|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
10982823|NCT00970294|FG000|Participant Flow|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
10982824|NCT00970294|OG000|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
10982825|NCT00970294|EG000|Reported Event|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
10982826|NCT00970307|BG000|Baseline|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982827|NCT00970307|BG001|Baseline|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982828|NCT00970307|BG002|Baseline|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982829|NCT00970307|BG003|Baseline|Total|Total of all reporting groups
10982830|NCT00970307|FG000|Participant Flow|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982831|NCT00970307|FG001|Participant Flow|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982832|NCT00970307|FG002|Participant Flow|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982833|NCT00970307|OG000|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982834|NCT00970307|OG001|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982835|NCT00970307|OG002|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982836|NCT00970307|EG000|Reported Event|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982837|NCT00970307|EG001|Reported Event|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982838|NCT00970307|EG002|Reported Event|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
10982839|NCT00970320|BG000|Baseline|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
10982840|NCT00970320|BG001|Baseline|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
10982841|NCT00970320|BG002|Baseline|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
10982842|NCT00970320|BG003|Baseline|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
10982843|NCT00970320|BG004|Baseline|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
10982844|NCT00970320|BG005|Baseline|Total|Total of all reporting groups
10982845|NCT00970320|FG000|Participant Flow|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
10982846|NCT00970320|FG001|Participant Flow|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
10982847|NCT00970320|FG002|Participant Flow|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
10982848|NCT00970320|FG003|Participant Flow|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
10982849|NCT00970320|FG004|Participant Flow|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.
10982850|NCT00970320|OG000|Outcome|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
10982851|NCT00970320|OG001|Outcome|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
10982852|NCT00970320|OG002|Outcome|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
10982853|NCT00970320|OG003|Outcome|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
10982854|NCT00970320|OG004|Outcome|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
10982855|NCT00970320|EG000|Reported Event|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
10982856|NCT00970320|EG001|Reported Event|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
10982857|NCT00970320|EG002|Reported Event|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
10982858|NCT00970320|EG003|Reported Event|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
10982859|NCT00970320|EG004|Reported Event|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
10982860|NCT00970359|BG000|Baseline|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
10982861|NCT00970359|FG000|Participant Flow|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
10848670|NCT00290888|OG001|Outcome|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
10848671|NCT00290888|OG001|Outcome|Arthorscopic Rotator Cuff Repair With Acromioplasty|ACR-A Acromioplasty
10848672|NCT00290888|EG000|Reported Event|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
10982862|NCT00970359|OG000|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
10982863|NCT00970359|EG000|Reported Event|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
10982864|NCT00970489|BG000|Baseline|Olive Oil Capsule|Placebo : Olive Oil capsules
10982865|NCT00970489|BG001|Baseline|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
10982866|NCT00970489|BG002|Baseline|Total|Total of all reporting groups
10982867|NCT00970489|FG000|Participant Flow|Olive Oil Capsule|"Placebo : Olive Oil capsules All patients were randomized to receive n-3 Polyunsaturated fatty acids (PUFA) or matched placebo in equal numbers using computer-generated numbers, stratified by medical center.~Treatment: Either oral n-3 PUFA (1 g capsules, each containing ~850 mg of EPA+DHA) or matching placebo (olive oil, 1 g capsules).~Total loading dose = 8 g over 2 to 4 days pre-op, followed by 2 g/d post-op until hospital discharge or until post-op day 10, whichever sooner."
10982868|NCT00970489|FG001|Participant Flow|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
10982869|NCT00970489|OG000|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
10982870|NCT00970489|OG001|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
10982871|NCT00970489|EG000|Reported Event|Olive Oil Capsule|Placebo : Olive Oil capsules
10982872|NCT00970489|EG001|Reported Event|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
10982873|NCT00970502|BG000|Baseline|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
10982874|NCT00970502|FG000|Participant Flow|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
10982875|NCT00970502|OG000|Outcome|Celecoxib 200mg|Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
10982876|NCT00970502|OG001|Outcome|Celecoxib 400mg|Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
10982877|NCT00970502|OG002|Outcome|Celecoxib 600mg|Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
10982878|NCT00970502|OG000|Outcome|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
10982879|NCT00970502|OG000|Outcome|Erlotinib + Celecoxib|Recommended dose of celecoxib was 400mg
10982880|NCT00970502|EG000|Reported Event|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
10982881|NCT00970593|BG000|Baseline|OAP-189 0.2 mg IR|Participants received OAP-189 0.2 milligram (mg), immediate release (IR) infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982882|NCT00970593|BG001|Baseline|OAP-189 0.4 mg IR|Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982883|NCT00970593|BG002|Baseline|OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg|Participants received OAP-189 0.9 mg, modified release (MR) infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982884|NCT00970593|BG003|Baseline|OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982885|NCT00970593|BG004|Baseline|OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982886|NCT00970593|BG005|Baseline|Placebo IR|Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982887|NCT00970593|BG006|Baseline|Placebo MR|Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982888|NCT00970593|BG007|Baseline|Total|Total of all reporting groups
10982889|NCT00970593|FG000|Participant Flow|OAP-189 0.2 mg IR|Participants received OAP-189 0.2 milligram (mg), immediate release (IR) infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982890|NCT00970593|FG001|Participant Flow|OAP-189 0.4 mg IR|Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982891|NCT00970593|FG002|Participant Flow|OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg|Participants received OAP-189 0.9 mg, modified release (MR) infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982892|NCT00970593|FG003|Participant Flow|OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982893|NCT00970593|FG004|Participant Flow|OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982894|NCT00970593|FG005|Participant Flow|Placebo IR|Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982895|NCT00970593|FG006|Participant Flow|Placebo MR|Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982896|NCT00970593|OG000|Outcome|OAP-189 0.2 mg IR|Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982897|NCT00970593|OG001|Outcome|OAP-189 0.4 mg IR|Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982898|NCT00970593|OG002|Outcome|OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg|Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982899|NCT00970593|OG003|Outcome|OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982900|NCT00970593|OG004|Outcome|OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982901|NCT00970593|OG005|Outcome|Placebo IR|Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982902|NCT00970593|OG006|Outcome|Placebo MR|Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982903|NCT00970593|OG000|Outcome|OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg|Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982904|NCT00970593|OG001|Outcome|OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982905|NCT00970593|OG002|Outcome|OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982906|NCT00970593|OG003|Outcome|Placebo MR|Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982907|NCT00970593|EG000|Reported Event|OAP-189 0.2 mg IR|Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982908|NCT00970593|EG001|Reported Event|OAP-189 0.4 mg IR|Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982909|NCT00970593|EG002|Reported Event|OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg|Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982910|NCT00970593|EG003|Reported Event|OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982911|NCT00970593|EG004|Reported Event|OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg|Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982912|NCT00970593|EG005|Reported Event|Placebo IR|Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982913|NCT00970593|EG006|Reported Event|Placebo MR|Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).
10982914|NCT00970632|BG000|Baseline|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
10982915|NCT00970632|BG001|Baseline|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
10982916|NCT00970632|BG002|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
10982917|NCT00970632|BG003|Baseline|Total|Total of all reporting groups
10982918|NCT00970632|FG000|Participant Flow|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
10982919|NCT00970632|FG001|Participant Flow|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
10982920|NCT00970632|FG002|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
10982921|NCT00970632|OG000|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
10982922|NCT00970632|OG001|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
10982923|NCT00970632|OG002|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
10982924|NCT00970632|EG000|Reported Event|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
10982925|NCT00970632|EG001|Reported Event|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
10982926|NCT00970632|EG002|Reported Event|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
10982927|NCT00970684|BG000|Baseline|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
10982928|NCT00970684|FG000|Participant Flow|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
10982929|NCT00970684|OG000|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
10982930|NCT00970684|EG000|Reported Event|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
10982931|NCT00970814|BG000|Baseline|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
10982932|NCT00970814|BG001|Baseline|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
10982933|NCT00970814|BG002|Baseline|Total|Total of all reporting groups
10982934|NCT00970814|FG000|Participant Flow|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
10982935|NCT00970814|FG001|Participant Flow|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
10982936|NCT00970814|OG000|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
10982937|NCT00970814|OG001|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
10982938|NCT00970814|EG000|Reported Event|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
10982939|NCT00970814|EG001|Reported Event|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
10982940|NCT00970853|BG000|Baseline|Control|Control group
10982941|NCT00970853|BG001|Baseline|MOM Program Home Visiting|Mixed professional support home visiting program.
10848673|NCT00290888|EG001|Reported Event|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
10982942|NCT00970853|BG002|Baseline|Total|Total of all reporting groups
10982943|NCT00970853|FG000|Participant Flow|Control|Control group
10982944|NCT00970853|FG001|Participant Flow|MOM Program Home Visiting|Mixed professional support home visiting program.
10982945|NCT00970853|OG000|Outcome|Control|Control group
10982946|NCT00970853|OG001|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
10982947|NCT00970853|EG000|Reported Event|Control|Control group
10982948|NCT00970853|EG001|Reported Event|MOM Program Home Visiting|Mixed professional support home visiting program.
10982949|NCT00970944|BG000|Baseline|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
10982950|NCT00970944|BG001|Baseline|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
10982951|NCT00970944|BG002|Baseline|Total|Total of all reporting groups
10982952|NCT00970944|FG000|Participant Flow|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
10982953|NCT00970944|FG001|Participant Flow|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
10982954|NCT00970944|OG000|Outcome|Amantadine|Amantadine (200-400 mg/day)
10982955|NCT00970944|OG001|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the study drug.
10982956|NCT00970944|OG001|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
10982957|NCT00970944|EG000|Reported Event|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
10982958|NCT00970944|EG001|Reported Event|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
10982959|NCT00971048|BG000|Baseline|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
10982960|NCT00971048|BG001|Baseline|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
10982961|NCT00971048|BG002|Baseline|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
10982962|NCT00971048|BG003|Baseline|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
10982963|NCT00971048|BG004|Baseline|Total|Total of all reporting groups
10982964|NCT00971048|FG000|Participant Flow|HP828-101 Treating DFU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had diabetic foot ulcers (DFU)
10982965|NCT00971048|FG001|Participant Flow|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU (3M Tegaderm Hydrogel)"
10982966|NCT00971048|FG002|Participant Flow|HP828-101 Treating PU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had pressure ulcers (PU)
10982967|NCT00971048|FG003|Participant Flow|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
10982968|NCT00971048|OG000|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
10982969|NCT00971048|OG001|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
10982970|NCT00971048|OG002|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
10982971|NCT00971048|OG003|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
10982972|NCT00971048|OG000|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
10982973|NCT00971048|OG002|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
10874596|NCT00434122|EG000|Reported Event|Degarelix, 2.5 mg|"Combination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg.~Degarelix Mid-luteal, 2.5 mg: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.~Degarelix Follicular, 2.5 mg: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6."
10874597|NCT00434122|EG001|Reported Event|Ganirelix, 0.25 mg|Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
10874598|NCT00434148|BG000|Baseline|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
10874599|NCT00434148|BG001|Baseline|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
10874600|NCT00434148|BG002|Baseline|Total|Total of all reporting groups
10874601|NCT00434148|FG000|Participant Flow|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
10874602|NCT00434148|FG001|Participant Flow|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
10874603|NCT00434148|OG000|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
10874604|NCT00434148|OG001|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
10874605|NCT00434148|EG000|Reported Event|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
10874606|NCT00434148|EG001|Reported Event|Pasireotide 900 ug|At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
10874607|NCT00434161|BG000|Baseline|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
10874608|NCT00434161|BG001|Baseline|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
10874609|NCT00434161|BG002|Baseline|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
10874610|NCT00434161|BG003|Baseline|Total|Total of all reporting groups
10874611|NCT00434161|FG000|Participant Flow|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and placebo on Days 0, 1 and 2 after high dose chemotherapy.
10879359|NCT00457301|FG000|Participant Flow|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
10848674|NCT00291018|BG000|Baseline|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized
10848675|NCT00291018|BG001|Baseline|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized
10848676|NCT00291018|BG002|Baseline|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
10848677|NCT00291018|BG003|Baseline|Total|Total of all reporting groups
10848678|NCT00291018|FG000|Participant Flow|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
10848679|NCT00291018|FG001|Participant Flow|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
10848680|NCT00291018|FG002|Participant Flow|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
10848681|NCT00291018|OG000|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized
10848682|NCT00291018|OG001|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized
10848683|NCT00291018|OG002|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
10848684|NCT00291018|OG000|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
10848685|NCT00291018|OG001|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
10848686|NCT00291018|OG002|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
10848687|NCT00291018|EG000|Reported Event|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
10848688|NCT00291018|EG001|Reported Event|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
10848689|NCT00291018|EG002|Reported Event|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
10848690|NCT00291135|BG000|Baseline|Letrozole|Letrozole, 2.5 mg daily for six months
10848691|NCT00291135|FG000|Participant Flow|Letrozole|Letrozole, 2.5 mg daily for six months
10848692|NCT00291135|OG000|Outcome|Letrozole|Letrozole, 2.5 mg daily for six months
10848693|NCT00291135|EG000|Reported Event|Letrozole|Letrozole, 2.5 mg daily for six months
10848694|NCT00291161|BG000|Baseline|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
10848695|NCT00291161|BG001|Baseline|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
10848696|NCT00291161|BG002|Baseline|Caregivers-PDC Group|Caregivers to veterans with diagnosed dementia receiving the PDC Intervention
10848697|NCT00291161|BG003|Baseline|Caregivers-Usual Care Comparison Group|Caregivers to veterans with diagnosed dementia receiving educational materials and usual care
10848698|NCT00291161|BG004|Baseline|Total|Total of all reporting groups
10848699|NCT00291161|FG000|Participant Flow|Veterans: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
10848700|NCT00291161|FG001|Participant Flow|Veterans: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
10848701|NCT00291161|FG002|Participant Flow|Caregivers: Partners in Dementia Care Intervention|Caregivers for Veterans assigned to the Partners in Dementia Care Intervention
10848702|NCT00291161|FG003|Participant Flow|Caregivers: Usual Care Comparison|Caregivers of the Veterans assigned to the Usual Care Comparison
10848703|NCT00291161|OG000|Outcome|Caregivers: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
10848704|NCT00291161|OG001|Outcome|Caregivers: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
10848705|NCT00291161|OG000|Outcome|Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
10848706|NCT00291161|OG001|Outcome|Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
10848707|NCT00291161|EG000|Reported Event|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
10848708|NCT00291161|EG001|Reported Event|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
10848709|NCT00291187|BG000|Baseline|Placebo|Taken orally 30 minutes prior to bedtime.
10848710|NCT00291187|BG001|Baseline|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
10848711|NCT00291187|BG002|Baseline|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
10982974|NCT00971048|EG000|Reported Event|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
10982975|NCT00971048|EG001|Reported Event|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
10982976|NCT00971048|EG002|Reported Event|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
10982977|NCT00971048|EG003|Reported Event|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
10982978|NCT00971178|BG000|Baseline|Local Dexmedetomidine|local dexmedetomidine: Preoperative normal saline infusion and 1mcg/kg dexmedetomidine infiltrated locally to wound at the end of operation.
10982979|NCT00971178|BG001|Baseline|Normal Saline|Peripheral normal saline: Same volume of normal saline as dexmedetomidine is infiltrated and IV infusion.
10982980|NCT00971178|BG002|Baseline|IV Dexmedetomidine|IV dexmedetomidine: IV dexmedetomidine 1mcg/kg peroperative and normal saline infiltrated to wound at the end of operation
10982981|NCT00971178|BG003|Baseline|Total|Total of all reporting groups
10982982|NCT00971178|FG000|Participant Flow|Local Dexmedetomidine|Given intravenous 0.9% saline before incision and dexmedetomidine (1 mg/mL) infiltrated to the 4 surgical wound sites at the end of surgery.
10982983|NCT00971178|FG001|Participant Flow|Normal Saline|0.9% saline given intravenously before incision and infiltrated at the end of surgery to the 4 wound sites.
10982984|NCT00971178|FG002|Participant Flow|IV Dexmedetomidine|Given intravenous dexmedetomidine (1 mg/kg), infused over 10 minutes before incision and 0.9% saline infiltrated to 4 surgical wound sites at the end of the surgery.
10982985|NCT00971178|OG000|Outcome|Local Dexmedetomidine|Given intravenous 0.9% saline before incision and dexmedetomidine (1 mg/mL) infiltrated to the 4 surgical wound sites at the end of surgery.
10982986|NCT00971178|OG001|Outcome|Normal Saline|0.9% saline given intravenously before incision and infiltrated at the end of surgery to the 4 wound sites.
10982987|NCT00971178|OG002|Outcome|IV Dexmedetomidine|Given intravenous dexmedetomidine (1 mg/kg), infused over 10 minutes before incision and 0.9% saline infiltrated to 4 surgical wound sites at the end of the surgery.
10982988|NCT00971178|EG000|Reported Event|Local Dexmedetomidine|Intravenous 0.9% saline before incision and dexmedetomidine (1 mg/mL) infiltrated to the 4 surgical wound sites at the end of surgery.
10982989|NCT00971178|EG001|Reported Event|Normal Saline|Intravenous 0.9% saline before incision and 0.9% saline infiltrated at the end of surgery to the 4 wound sites.
10982990|NCT00971178|EG002|Reported Event|IV Dexmedetomidine|Intravenous dexmedetomidine (1 mg/kg), infused over 10 minutes before incision and 0.9% saline infiltrated to 4 surgical wound sites at the end of the surgery.
10982991|NCT00971204|BG000|Baseline|Treatment With HeartLight|Treatment of PAF with HeartLight System PVI ablation
10982992|NCT00971204|FG000|Participant Flow|Treatment With EAS-AC|"Treatment of PAF with EAS-AC~CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation"
10982993|NCT00971204|OG000|Outcome|Treatment With HeartLight|"Treatment of PAF with HeartLight System~CardioFocus HeartLight Endoscopic Ablation System: PVI ablation"
10982994|NCT00971204|EG000|Reported Event|Treatment With HeartLight|Treatment of PAF with HeartLight
10982995|NCT00971243|BG000|Baseline|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10982996|NCT00971243|BG001|Baseline|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10982997|NCT00971243|BG002|Baseline|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10982998|NCT00971243|BG003|Baseline|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10982999|NCT00971243|BG004|Baseline|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983000|NCT00971243|BG005|Baseline|Total|Total of all reporting groups
10983001|NCT00971243|FG000|Participant Flow|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983002|NCT00971243|FG001|Participant Flow|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983003|NCT00971243|FG002|Participant Flow|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983004|NCT00971243|FG003|Participant Flow|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983005|NCT00971243|FG004|Participant Flow|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983006|NCT00971243|OG000|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983007|NCT00971243|OG001|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983008|NCT00971243|OG002|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983009|NCT00971243|OG003|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983010|NCT00971243|OG004|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
10983011|NCT00971243|EG000|Reported Event|Teneli 5mg+Met|Teneligliptin 5mg plus Metformin
10983012|NCT00971243|EG001|Reported Event|Teneli 10 mg+Met|Teneligliptin 10mg plus Metformin
10848712|NCT00291187|BG003|Baseline|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
10848713|NCT00291187|BG004|Baseline|Total|Total of all reporting groups
10848714|NCT00291187|FG000|Participant Flow|Placebo|taken orally 30 minutes prior to bedtime
10848715|NCT00291187|FG001|Participant Flow|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
10848716|NCT00291187|FG002|Participant Flow|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
10848717|NCT00291187|FG003|Participant Flow|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
10848718|NCT00291187|OG000|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
10848719|NCT00291187|OG001|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
10848720|NCT00291187|OG002|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
10848721|NCT00291187|OG003|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
10848722|NCT00291187|OG001|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
10848723|NCT00291187|OG002|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
10848724|NCT00291187|OG003|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
10848725|NCT00291187|OG000|Outcome|Placebo|Taken orally 30 minutes prior to bedtime
10848726|NCT00291187|EG000|Reported Event|Placebo|Taken orally 30 minutes prior to bedtime.
10848727|NCT00291187|EG001|Reported Event|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
10848728|NCT00291187|EG002|Reported Event|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
10848729|NCT00291187|EG003|Reported Event|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
10848730|NCT00291226|BG000|Baseline|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or sprinkles (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
10848731|NCT00291226|BG001|Baseline|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or sprinkles (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
10848732|NCT00291226|BG002|Baseline|Total|Total of all reporting groups
10848733|NCT00291226|FG000|Participant Flow|Glycine|Glycine dosing group.
10848734|NCT00291226|FG001|Participant Flow|Placebo Group|Glycine and placebo dosing group.
10848735|NCT00291226|OG000|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or sprinkles (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
10848736|NCT00291226|OG001|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or sprinkles (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
10848737|NCT00291226|EG000|Reported Event|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or sprinkles (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
10848738|NCT00291226|EG001|Reported Event|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or sprinkles (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
10848893|NCT00292318|OG001|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
10874612|NCT00434161|FG001|Participant Flow|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of placebo as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy.
10874613|NCT00434161|FG002|Participant Flow|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy
10874614|NCT00434161|OG000|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
10874615|NCT00434161|OG001|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
10874616|NCT00434161|OG002|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
10874617|NCT00434161|OG000|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
10874618|NCT00434161|OG002|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
10874619|NCT00434161|OG000|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
10874620|NCT00434161|OG001|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
10874621|NCT00434161|OG000|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
10874622|NCT00434161|OG001|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
10874623|NCT00434161|OG000|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
10874624|NCT00434161|EG000|Reported Event|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set.
10874625|NCT00434161|EG001|Reported Event|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
10874626|NCT00434161|EG002|Reported Event|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set.
10874627|NCT00434213|BG000|Baseline|Daytrana|Methylphenidate Transdermal System (MTS)
10874628|NCT00434213|FG000|Participant Flow|Daytrana|Methylphenidate Transdermal System (MTS)
10874629|NCT00434213|OG000|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
10874630|NCT00434213|EG000|Reported Event|Daytrana|Methylphenidate Transdermal System (MTS)
10874631|NCT00434252|BG000|Baseline|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
10874632|NCT00434252|BG001|Baseline|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
10874633|NCT00434252|BG002|Baseline|Total|Total of all reporting groups
10874634|NCT00434252|FG000|Participant Flow|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
10874635|NCT00434252|FG001|Participant Flow|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
10874636|NCT00434252|OG000|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
10874637|NCT00434252|OG001|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
10874638|NCT00434252|EG000|Reported Event|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
10874639|NCT00434252|EG001|Reported Event|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
10874640|NCT00434278|BG000|Baseline|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
10874641|NCT00434278|BG001|Baseline|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
10874642|NCT00434278|BG002|Baseline|Total|Total of all reporting groups
10874643|NCT00434278|FG000|Participant Flow|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
10874644|NCT00434278|FG001|Participant Flow|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
10874645|NCT00434278|OG000|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
10874646|NCT00434278|OG001|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
10874647|NCT00434278|EG000|Reported Event|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
10874648|NCT00434278|EG001|Reported Event|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
10874649|NCT00434304|BG000|Baseline|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
10874650|NCT00434304|FG000|Participant Flow|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
10874651|NCT00434304|OG000|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
10874652|NCT00434304|EG000|Reported Event|Ropinirole PR/XR (Treatment Phase)|Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 mg as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52.
10874653|NCT00434304|EG001|Reported Event|Ropinirole PR/XR (Taper Phase)|The dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
10874654|NCT00434330|BG000|Baseline|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
10874655|NCT00434330|BG001|Baseline|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
10874656|NCT00434330|BG002|Baseline|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874657|NCT00434330|BG003|Baseline|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874658|NCT00434330|BG004|Baseline|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874659|NCT00434330|BG005|Baseline|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874660|NCT00434330|BG006|Baseline|Total|Total of all reporting groups
10874661|NCT00434330|FG000|Participant Flow|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
10874662|NCT00434330|FG001|Participant Flow|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
10874663|NCT00434330|FG002|Participant Flow|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874664|NCT00434330|FG003|Participant Flow|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874665|NCT00434330|FG004|Participant Flow|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874666|NCT00434330|FG005|Participant Flow|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874667|NCT00434330|OG000|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
10874668|NCT00434330|OG001|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
10874669|NCT00434330|OG002|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874670|NCT00434330|OG003|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874671|NCT00434330|OG004|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874672|NCT00434330|OG005|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874673|NCT00434330|EG000|Reported Event|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
10874674|NCT00434330|EG001|Reported Event|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
10874675|NCT00434330|EG002|Reported Event|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874676|NCT00434330|EG003|Reported Event|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874677|NCT00434330|EG004|Reported Event|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874678|NCT00434330|EG005|Reported Event|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
10874679|NCT00434356|BG000|Baseline|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
10983013|NCT00971243|EG002|Reported Event|Teneli 20 mg+Met|Teneligliptin 20mg plus Metformin
10983014|NCT00971243|EG003|Reported Event|Teneli 40 mg+Met|Teneligliptin 40mg plus Metformin
10983015|NCT00971243|EG004|Reported Event|Placebo+Met|Placebo plus Metformin
10983016|NCT00971282|BG000|Baseline|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
10983017|NCT00971282|FG000|Participant Flow|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
10983018|NCT00971282|OG000|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
10983019|NCT00971282|OG001|Outcome|Differin Alone|Differin applied once daily (evening)
10983020|NCT00971282|EG000|Reported Event|Cetaphil + Differin|intra-individual comparison
10983021|NCT00971282|EG001|Reported Event|Differin Alone|intra-individual comparison
10983022|NCT00971295|BG000|Baseline|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
10983023|NCT00971295|FG000|Participant Flow|Treatment Sequence A|"Treatment Sequence A:~Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period~850 mg metformin hydrochloride, 1200 mg ESL"
10983024|NCT00971295|FG001|Participant Flow|Treatment Sequence B|"Treatment Sequence B:~Metformin period followed by washout period followed by Metformin + Eslicarbazepine acetate~850 mg metformin hydrochloride, 1200 mg ESL"
10983025|NCT00971295|OG000|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
10983026|NCT00971295|OG001|Outcome|Metformin|Metformin HCl 850 mg
10983027|NCT00971295|EG000|Reported Event|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
10983028|NCT00971295|EG001|Reported Event|Metformin|Metformin HCl 850 mg
10983029|NCT00971321|BG000|Baseline|GSK2340272A F1 Group|Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
10983030|NCT00971321|BG001|Baseline|GSK2340272A F2 Group|Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
10983031|NCT00971321|BG002|Baseline|Total|Total of all reporting groups
10983032|NCT00971321|FG000|Participant Flow|GSK2340272A F1 Group|Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
10983033|NCT00971321|FG001|Participant Flow|GSK2340272A F2 Group|Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
10983034|NCT00971321|OG000|Outcome|GSK2340272A F1 Group|Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
10983035|NCT00971321|OG001|Outcome|GSK2340272A F2 Group|Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
10983036|NCT00971321|EG000|Reported Event|GSK 2340272A F1 Group|Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
10983037|NCT00971321|EG001|Reported Event|GSK 2340272A F2 Group|Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
10983038|NCT00971425|BG000|Baseline|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
10983039|NCT00971425|BG001|Baseline|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
10983040|NCT00971425|BG002|Baseline|Total|Total of all reporting groups
10983041|NCT00971425|FG000|Participant Flow|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
10983042|NCT00971425|FG001|Participant Flow|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
10983043|NCT00971425|OG000|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
10983044|NCT00971425|OG001|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
10983045|NCT00971425|EG000|Reported Event|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
10983046|NCT00971425|EG001|Reported Event|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
10983047|NCT00971620|BG000|Baseline|BTX-A|BTX-A intralesional injection
10983048|NCT00971620|BG001|Baseline|Placebo/Saline|Saline intralesional injection
10983049|NCT00971620|BG002|Baseline|Total|Total of all reporting groups
10983050|NCT00971620|FG000|Participant Flow|BTX-A|BTX-A intralesional injection
10983051|NCT00971620|FG001|Participant Flow|Placebo/Saline|Saline intralesional injection
10983052|NCT00971620|OG000|Outcome|BTX-A|BTX-A intralesional injection
10983053|NCT00971620|OG001|Outcome|Placebo/Saline|Saline intralesional injection
10983054|NCT00971620|EG000|Reported Event|BTX-A|BTX-A intralesional injection
10983055|NCT00971620|EG001|Reported Event|Placebo/Saline|Saline intralesional injection
10983056|NCT00971633|BG000|Baseline|All Participants|All randomized participants
10983057|NCT00971633|FG000|Participant Flow|OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet then United States (U.S.) tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally./Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally./Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
10983058|NCT00971633|FG001|Participant Flow|U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet|U.K. tablet then U.S. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally /Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally.
10983059|NCT00971633|FG002|Participant Flow|U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet|U.S. tablet then OE U.K. tablet then U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K ZOFRAN (ondansetron) taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
10983060|NCT00971633|FG003|Participant Flow|OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet|OE U.K. tablet then U.S. tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
10983061|NCT00971633|FG004|Participant Flow|U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet|U.K. tablet then OE U.K. tablet then U.S. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
10983062|NCT00971633|FG005|Participant Flow|U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet|U.S. tablet then U.K. tablet then OE U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally
10983063|NCT00971633|OG000|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
10983064|NCT00971633|OG001|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
10983065|NCT00971633|OG002|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
10983066|NCT00971633|EG000|Reported Event|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
10983067|NCT00971633|EG001|Reported Event|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
10983068|NCT00971633|EG002|Reported Event|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
10983069|NCT00971737|BG000|Baseline|Cyclophosphamide and Vaccine Only|"Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.~allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally~cyclophosphamide: Given IV"
10983070|NCT00971737|BG001|Baseline|Cyclophosphamide, Vaccine and Trastuzumab|"Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.~allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally~trastuzumab: Given IV~cyclophosphamide: Given IV"
10874680|NCT00434356|BG001|Baseline|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
10874681|NCT00434356|BG002|Baseline|Total|Total of all reporting groups
10874682|NCT00434356|FG000|Participant Flow|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
10874683|NCT00434356|FG001|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
10874684|NCT00434356|OG000|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
10874685|NCT00434356|OG001|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
10874686|NCT00434356|EG000|Reported Event|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
10874687|NCT00434356|EG001|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
10874688|NCT00434421|BG000|Baseline|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
10874689|NCT00434421|FG000|Participant Flow|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
10874690|NCT00434421|OG000|Outcome|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
10874691|NCT00434421|EG000|Reported Event|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
10874692|NCT00434434|BG000|Baseline|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874693|NCT00434434|BG001|Baseline|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874694|NCT00434434|BG002|Baseline|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874695|NCT00434434|BG003|Baseline|Total|Total of all reporting groups
10874696|NCT00434434|FG000|Participant Flow|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874697|NCT00434434|FG001|Participant Flow|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874698|NCT00434434|FG002|Participant Flow|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874699|NCT00434434|OG000|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874700|NCT00434434|OG001|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874701|NCT00434434|OG002|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10983071|NCT00971737|BG002|Baseline|Total|Total of all reporting groups
10983072|NCT00971737|FG000|Participant Flow|Cyclophosphamide and Vaccine Only|"Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.~allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally~cyclophosphamide: Given IV"
10983073|NCT00971737|FG001|Participant Flow|Cyclophosphamide, Vaccine and Trastuzumab|"Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.~allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally~trastuzumab: Given IV~cyclophosphamide: Given IV"
10983074|NCT00971737|OG000|Outcome|Cyclophosphamide and Vaccine Only|"Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.~allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally~cyclophosphamide: Given IV"
10983075|NCT00971737|OG001|Outcome|Cyclophosphamide, Vaccine and Trastuzumab|"Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.~allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally~trastuzumab: Given IV~cyclophosphamide: Given IV"
10983076|NCT00971737|EG000|Reported Event|Cyclophosphamide and Vaccine Only|"Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.~allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally~cyclophosphamide: Given IV"
10983077|NCT00971737|EG001|Reported Event|Cyclophosphamide, Vaccine and Trastuzumab|"Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.~allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally~trastuzumab: Given IV~cyclophosphamide: Given IV"
10983078|NCT00971750|BG000|Baseline|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
10983079|NCT00971750|FG000|Participant Flow|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
10983080|NCT00971750|OG000|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
10983081|NCT00971750|OG001|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
10983082|NCT00971750|OG001|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively during gastric bypass
10983083|NCT00971750|EG000|Reported Event|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
10983084|NCT00971789|BG000|Baseline|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
10983085|NCT00971789|FG000|Participant Flow|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
10983086|NCT00971789|OG000|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
10983087|NCT00971789|EG000|Reported Event|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
10983088|NCT00971841|BG000|Baseline|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original Study CA139-540 (NCT 00344552)and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest. One treatment course consisted of 49 days total.
10983089|NCT00971841|FG000|Participant Flow|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original study (100 mg/m^2, 80 mg/m^2, or 60 mg/m^2) and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consisted of 49 days total.
10983090|NCT00971841|OG000|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
10983091|NCT00971841|EG000|Reported Event|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
11007143|NCT01089556|OG000|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
10983092|NCT00971932|BG000|Baseline|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
10983093|NCT00971932|FG000|Participant Flow|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
10983094|NCT00971932|OG000|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
10983095|NCT00971932|EG000|Reported Event|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
10983096|NCT00971945|BG000|Baseline|Treatment Arm|Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days).
10983097|NCT00971945|FG000|Participant Flow|Treatment Arm|Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days).
10983098|NCT00971945|OG000|Outcome|Treatment Arm|Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days).
10983099|NCT00971945|EG000|Reported Event|Treatment Arm|Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days).
10983100|NCT00971997|BG000|Baseline|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
10983101|NCT00971997|FG000|Participant Flow|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
10983102|NCT00971997|OG000|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
10983103|NCT00971997|OG000|Outcome|Lispro 50/50 Once Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
10983104|NCT00971997|OG001|Outcome|Lispro 50/50 Twice Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
10983105|NCT00971997|OG002|Outcome|Lispro 50/50 Three Times Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
10983106|NCT00971997|EG000|Reported Event|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
10983107|NCT00972088|BG000|Baseline|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
10983108|NCT00972088|FG000|Participant Flow|a Single Arm Group, Patients With Ano Rectal Disease|patients suffering from anorectal disease with a negative standard work up to rule out crohn's disease
10983109|NCT00972088|OG000|Outcome|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
10983110|NCT00972088|EG000|Reported Event|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
10983111|NCT00972153|BG000|Baseline|No Device Used|
10983112|NCT00972153|BG001|Baseline|Device Attached, Not Activated|
10983113|NCT00972153|BG002|Baseline|Device Deployed and Activated|
10983114|NCT00972153|BG003|Baseline|Total|Total of all reporting groups
10983115|NCT00972153|FG000|Participant Flow|No Device Used|
10983116|NCT00972153|FG001|Participant Flow|Device Attached, Not Activated|
10983117|NCT00972153|FG002|Participant Flow|Device Deployed and Activated|
10983118|NCT00972153|OG000|Outcome|No Device Used|
10983119|NCT00972153|OG001|Outcome|Device Attached, Not Activated|
10983120|NCT00972153|OG002|Outcome|Device Deployed and Activated|
10983121|NCT00972153|EG000|Reported Event|No Device Used|
10983122|NCT00972153|EG001|Reported Event|Device Attached, Not Activated|
10983123|NCT00972153|EG002|Reported Event|Device Deployed and Activated|
10983124|NCT00972205|BG000|Baseline|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
10983125|NCT00972205|FG000|Participant Flow|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
10983126|NCT00972205|OG000|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
10983127|NCT00972205|EG000|Reported Event|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
10983128|NCT00972244|BG000|Baseline|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
10983129|NCT00972244|BG001|Baseline|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
10983130|NCT00972244|BG002|Baseline|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
10983131|NCT00972244|BG003|Baseline|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
10983132|NCT00972244|BG004|Baseline|Placebo|Placebo Comparator
10983133|NCT00972244|BG005|Baseline|Total|Total of all reporting groups
10983134|NCT00972244|FG000|Participant Flow|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
10983135|NCT00972244|FG001|Participant Flow|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
10983136|NCT00972244|FG002|Participant Flow|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
10983137|NCT00972244|FG003|Participant Flow|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
10983138|NCT00972244|FG004|Participant Flow|Placebo|Placebo Comparator
10983139|NCT00972244|OG000|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
10983140|NCT00972244|OG001|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
10983141|NCT00972244|OG002|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
10983142|NCT00972244|OG003|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
10983143|NCT00972244|OG004|Outcome|Placebo|Placebo Comparator
10983144|NCT00972244|EG000|Reported Event|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
10983145|NCT00972244|EG001|Reported Event|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
10983146|NCT00972244|EG002|Reported Event|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
10983147|NCT00972244|EG003|Reported Event|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
10983148|NCT00972244|EG004|Reported Event|Placebo|Placebo Comparator
10983149|NCT00972283|BG000|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
10983150|NCT00972283|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
10983151|NCT00972283|BG002|Baseline|Total|Total of all reporting groups
10983152|NCT00972283|FG000|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
10983153|NCT00972283|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
10983154|NCT00972283|OG000|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
10983155|NCT00972283|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
10983156|NCT00972283|EG000|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
10983157|NCT00972283|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
10983158|NCT00972322|BG000|Baseline|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
10983159|NCT00972322|BG001|Baseline|Placebo|Placebo to MK-8245, twice daily for 28 days
10983160|NCT00972322|BG002|Baseline|Total|Total of all reporting groups
10983161|NCT00972322|FG000|Participant Flow|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
10983162|NCT00972322|FG001|Participant Flow|Placebo|Placebo to MK-8245, twice daily for 28 days
10983163|NCT00972322|OG000|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
10983164|NCT00972322|OG001|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
10983165|NCT00972322|EG000|Reported Event|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
10983166|NCT00972322|EG001|Reported Event|Placebo|Placebo to MK-8245, twice daily for 28 days
10983167|NCT00972335|BG000|Baseline|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
10983168|NCT00972335|FG000|Participant Flow|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
10983169|NCT00972335|OG000|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
10983170|NCT00972335|EG000|Reported Event|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
10983171|NCT00972374|BG000|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983172|NCT00972374|BG001|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983173|NCT00972374|BG002|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983174|NCT00972374|BG003|Baseline|Total|Total of all reporting groups
10983175|NCT00972374|FG000|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983176|NCT00972374|FG001|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983177|NCT00972374|FG002|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983178|NCT00972374|OG000|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983179|NCT00972374|OG001|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983180|NCT00972374|OG002|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983181|NCT00972374|EG000|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983182|NCT00972374|EG001|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983183|NCT00972374|EG002|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
10983184|NCT00972439|BG000|Baseline|Ortho-Novum® 1/35|Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
10983185|NCT00972439|BG001|Baseline|Ovcon Fe®|Ovcon Fe® is an oral contraceptive that contains less progestin.
10983186|NCT00972439|BG002|Baseline|Total|Total of all reporting groups
10983187|NCT00972439|FG000|Participant Flow|Ortho-Novum® 1/35|Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
10983188|NCT00972439|FG001|Participant Flow|Ovcon Fe®|Ovcon Fe® is an oral contraceptive that contains less progestin.
10983189|NCT00972439|OG000|Outcome|Ortho-Novum® 1/35|Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
10983190|NCT00972439|OG001|Outcome|Ovcon Fe®|Ovcon Fe® is an oral contraceptive that contains less progestin.
10983191|NCT00972439|EG000|Reported Event|Ortho-Novum® 1/35|Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
10983192|NCT00972439|EG001|Reported Event|Ovcon Fe®|Ovcon Fe® is an oral contraceptive that contains less progestin.
10983193|NCT00972504|BG000|Baseline|Overall Study|Participants randomized to receive once daily GSK1004723 1000 µg nasal spray solution for 3 days or oral tablet of GSK835726 10 mg or oral capsule of cetirizine 10 mg or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983194|NCT00972504|FG000|Participant Flow|Overall Study|Participants randomized to receive once daily GSK1004723 (1000 micrograms [µg]) nasal spray solution for 3 days or oral tablet of GSK835726 (10 milligram [mg]) or oral capsule of cetirizine (10 mg) or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983195|NCT00972504|OG000|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983196|NCT00972504|OG001|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983197|NCT00972504|OG002|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983198|NCT00972504|OG003|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983199|NCT00972504|EG000|Reported Event|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983200|NCT00972504|EG001|Reported Event|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983201|NCT00972504|EG002|Reported Event|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983202|NCT00972504|EG003|Reported Event|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
10983203|NCT00972517|BG000|Baseline|Group A|Subjects receiving alternative dose of GSK23440272A vaccine
10983204|NCT00972517|FG000|Participant Flow|Flu BS1_3-5 Years Group|Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983205|NCT00972517|FG001|Participant Flow|Flu BS1_6-9 Years Group|Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983206|NCT00972517|FG002|Participant Flow|Flu BS1_10-17 Years Group|Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983207|NCT00972517|FG003|Participant Flow|Flu BS2_3-5 Years Group|Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983208|NCT00972517|FG004|Participant Flow|Flu BS2_6-9 Years Group|Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983209|NCT00972517|FG005|Participant Flow|Flu BS2_10-17 Years Group|Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983210|NCT00972517|OG000|Outcome|Flu BS1_3-5 Years Group|Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983211|NCT00972517|OG001|Outcome|Flu BS1_6-9 Years Group|Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983212|NCT00972517|OG002|Outcome|Flu BS1_10-17 Years Group|Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983213|NCT00972517|OG003|Outcome|Flu BS2_3-5 Years Group|Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983214|NCT00972517|OG004|Outcome|Flu BS2_6-9 Years Group|Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983215|NCT00972517|OG005|Outcome|Flu BS2_10-17 Years Group|Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983216|NCT00972517|OG000|Outcome|Flu BS2_3-5 Years Group|Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983217|NCT00972517|OG001|Outcome|Flu BS2_6-9 Years Group|Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983218|NCT00972517|OG002|Outcome|Flu BS2_10-17 Years Group|Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983219|NCT00972517|OG000|Outcome|Flu pooled_3-5 Years Group|Pooled data of subjects aged 3 to 5 years from the Flu BS1 and Flu BS2 Groups
10983220|NCT00972517|OG001|Outcome|Flu pooled_6-9 Years Group|Pooled data of subjects aged 6 to 9 years from the Flu BS1 and Flu BS2 Groups
10983221|NCT00972517|OG002|Outcome|Flu pooled_10-17 Years Group|Pooled data of subjects aged 10 to 17 years from the Flu BS1 and Flu BS2 Groups
10983222|NCT00972517|EG000|Reported Event|Flu BS1_3-5 Years Group|Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983223|NCT00972517|EG001|Reported Event|Flu BS1_6-9 Years Group|Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983224|NCT00972517|EG002|Reported Event|Flu BS1_10-17 Years Group|Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
10983225|NCT00972517|EG003|Reported Event|Flu BS2_3-5 Years Group|Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983226|NCT00972517|EG004|Reported Event|Flu BS2_6-9 Years Group|Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983227|NCT00972517|EG005|Reported Event|Flu BS2_10-17 Years Group|Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
10983228|NCT00972530|BG000|Baseline|Activity|Normal activity without restrictions
10983229|NCT00972530|BG001|Baseline|Immobilisation|48 hours postinjection rest
10983230|NCT00972530|BG002|Baseline|Total|Total of all reporting groups
10983231|NCT00972530|FG000|Participant Flow|Activity|Normal activity without restrictions
10983232|NCT00972530|FG001|Participant Flow|Immobilisation|48 hours postinjection rest
10983233|NCT00972530|OG000|Outcome|Activity|Normal activity without restrictions
10983234|NCT00972530|OG001|Outcome|Immobilisation|48 hours postinjection rest
10983235|NCT00972530|EG000|Reported Event|Activity|Normal activity without restrictions
10983236|NCT00972530|EG001|Reported Event|Immobilisation|48 hours postinjection rest
10983237|NCT00972543|BG000|Baseline|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
10983238|NCT00972543|BG001|Baseline|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
10983239|NCT00972543|BG002|Baseline|Total|Total of all reporting groups
10983240|NCT00972543|FG000|Participant Flow|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
10983241|NCT00972543|FG001|Participant Flow|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
10983242|NCT00972543|OG000|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
10983243|NCT00972543|OG001|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
10983244|NCT00972543|EG000|Reported Event|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
10983245|NCT00972543|EG001|Reported Event|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
10983246|NCT00972595|BG000|Baseline|All Participants|All Randomized Participants
10983247|NCT00972595|FG000|Participant Flow|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
10983248|NCT00972595|FG001|Participant Flow|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
10983249|NCT00972595|OG000|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
10983250|NCT00972595|OG001|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
10983251|NCT00972595|EG000|Reported Event|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
10983252|NCT00972595|EG001|Reported Event|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
10983253|NCT00972621|BG000|Baseline|Vitrax II|Investigational dispersive viscoelastic
10983254|NCT00972621|BG001|Baseline|Viscoat|Currently marketed viscoelastic
10983255|NCT00972621|BG002|Baseline|Total|Total of all reporting groups
10983256|NCT00972621|FG000|Participant Flow|Vitrax II|Investigational dispersive viscoelastic
10983257|NCT00972621|FG001|Participant Flow|Viscoat|Currently marketed viscoelastic
10983258|NCT00972621|OG000|Outcome|Vitrax II|Vitrax II: Investigational Treatment
10983259|NCT00972621|OG001|Outcome|Viscoat|Viscoat: Control Treatment
10983260|NCT00972621|EG000|Reported Event|Vitrax II|Investigational dispersive viscoelastic
10983261|NCT00972621|EG001|Reported Event|Viscoat|Currently marketed viscoelastic
10983262|NCT00972725|BG000|Baseline|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
10983263|NCT00972725|BG001|Baseline|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
10983264|NCT00972725|BG002|Baseline|Total|Total of all reporting groups
10983265|NCT00972725|FG000|Participant Flow|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
10983266|NCT00972725|FG001|Participant Flow|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
10983267|NCT00972725|OG000|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
10983268|NCT00972725|OG001|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
10983269|NCT00972725|EG000|Reported Event|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
10983270|NCT00972725|EG001|Reported Event|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
10983271|NCT00972777|BG000|Baseline|Besifloxacin|0.6% ophthalmic suspension
10983272|NCT00972777|BG001|Baseline|Vehicle|Vehicle of besifloxacin ophthalmic suspension
10983273|NCT00972777|BG002|Baseline|Total|Total of all reporting groups
10983274|NCT00972777|FG000|Participant Flow|Besifloxacin|0.6% ophthalmic suspension
10983275|NCT00972777|FG001|Participant Flow|Vehicle|Vehicle of besifloxacin ophthalmic suspension
10983276|NCT00972777|OG000|Outcome|Besifloxacin|0.6% ophthalmic suspension
10983277|NCT00972777|OG001|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
10983278|NCT00972777|EG000|Reported Event|Besifloxacin|0.6% ophthalmic suspension
10983279|NCT00972777|EG001|Reported Event|Vehicle|Vehicle of besifloxacin ophthalmic suspension
10983280|NCT00972816|BG000|Baseline|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
10983281|NCT00972816|BG001|Baseline|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
10983282|NCT00972816|BG002|Baseline|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
10983283|NCT00972816|BG003|Baseline|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
10983284|NCT00972816|BG004|Baseline|15 Without MF59|1 dose of 15 µg A/H1N1
10983285|NCT00972816|BG005|Baseline|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
10983286|NCT00972816|BG006|Baseline|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
10983287|NCT00972816|BG007|Baseline|30 Without MF59|1 dose of 30 µg A/H1N1
10983288|NCT00972816|BG008|Baseline|Total|Total of all reporting groups
10983289|NCT00972816|FG000|Participant Flow|3.75_(50) MF59|3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
10983290|NCT00972816|FG001|Participant Flow|7.5_(0) MF59|7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
10983291|NCT00972816|FG002|Participant Flow|7.5_(50)MF59|7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
10983292|NCT00972816|FG003|Participant Flow|7.5_(100)MF59|7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
10983293|NCT00972816|FG004|Participant Flow|15_(0) MF59|15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
10983294|NCT00972816|FG005|Participant Flow|15_(50) MF59|15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
10983295|NCT00972816|FG006|Participant Flow|15_(100) MF59|15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
10983296|NCT00972816|FG007|Participant Flow|30_(0) MF59|30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
10983297|NCT00972816|OG000|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
10983298|NCT00972816|OG001|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
10983299|NCT00972816|OG002|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
10983300|NCT00972816|OG003|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
10983301|NCT00972816|OG004|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
10983302|NCT00972816|OG005|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
10983303|NCT00972816|OG006|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
10983304|NCT00972816|OG007|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
10983305|NCT00972816|EG000|Reported Event|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
10983306|NCT00972816|EG001|Reported Event|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
10983307|NCT00972816|EG002|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
10983308|NCT00972816|EG003|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
10983309|NCT00972816|EG004|Reported Event|15 Without MF59|1 dose of 15 µg A/H1N1
10983310|NCT00972816|EG005|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
10983311|NCT00972816|EG006|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
10983312|NCT00972816|EG007|Reported Event|30 Without MF59|1 dose of 30 µg A/H1N1
10983313|NCT00972959|BG000|Baseline|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
10983314|NCT00972959|FG000|Participant Flow|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
10983315|NCT00972959|OG000|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
10983316|NCT00972959|EG000|Reported Event|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
10983317|NCT00973102|BG000|Baseline|Premarin IV|"Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.~Premarin IV: One time dose of Premarin IV"
10983318|NCT00973102|BG001|Baseline|Placebo|"Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.~Placebo: One time dose of placebo."
10983319|NCT00973102|BG002|Baseline|Total|Total of all reporting groups
10983320|NCT00973102|FG000|Participant Flow|Premarin IV|"Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.~Premarin IV: One time dose of Premarin IV"
10983321|NCT00973102|FG001|Participant Flow|Placebo|"Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.~Placebo: One time dose of placebo."
10983322|NCT00973102|OG000|Outcome|Premarin IV|"Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.~Premarin IV: One time dose of Premarin IV"
11007144|NCT01089556|OG001|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
11007145|NCT01089556|OG000|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
11007146|NCT01089556|OG001|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
10983323|NCT00973102|OG001|Outcome|Placebo|"Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.~Placebo: One time dose of placebo."
10983324|NCT00973102|EG000|Reported Event|Premarin IV|"Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.~Premarin IV: One time dose of Premarin IV"
10983325|NCT00973102|EG001|Reported Event|Placebo|"Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.~Placebo: One time dose of placebo."
10983326|NCT00973349|BG000|Baseline|3.75_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age
10983327|NCT00973349|BG001|Baseline|7.5 w/o MF59 (18 to 64)|1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age
10983328|NCT00973349|BG002|Baseline|7.5_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
10983329|NCT00973349|BG003|Baseline|7.5_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
10983330|NCT00973349|BG004|Baseline|15 w/o MF59 (18 to 64)|1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age
10983331|NCT00973349|BG005|Baseline|15_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age
10983332|NCT00973349|BG006|Baseline|15_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen
10983333|NCT00973349|BG007|Baseline|30 w/o MF59 (18 to 64)|1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age
10983334|NCT00973349|BG008|Baseline|3.75_(50)MF59 (≥ 65 )|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age
10983335|NCT00973349|BG009|Baseline|7.5 w/o MF59 (≥ 65)|1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age
10983336|NCT00973349|BG010|Baseline|7.5_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
10983337|NCT00973349|BG011|Baseline|7.5_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
10983338|NCT00973349|BG012|Baseline|15 w/o MF59 (≥ 65)|1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age
10983339|NCT00973349|BG013|Baseline|15_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
10983340|NCT00973349|BG014|Baseline|15_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
10983341|NCT00973349|BG015|Baseline|30 w/o MF59 (≥ 65)|1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age
10983342|NCT00973349|BG016|Baseline|Total|Total of all reporting groups
10983343|NCT00973349|FG000|Participant Flow|3.75_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
10983344|NCT00973349|FG001|Participant Flow|7.5 w/o MF59 (18-64 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
10983345|NCT00973349|FG002|Participant Flow|7.5_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
10983346|NCT00973349|FG003|Participant Flow|7.5_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
10983347|NCT00973349|FG004|Participant Flow|15 w/o MF59 (18-64 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
10983348|NCT00973349|FG005|Participant Flow|15_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
10983349|NCT00973349|FG006|Participant Flow|15_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
10983350|NCT00973349|FG007|Participant Flow|30 w/o MF59(18-64 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
10983351|NCT00973349|FG008|Participant Flow|3.75_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
10983352|NCT00973349|FG009|Participant Flow|7.5 w/o MF59 (≥ 65 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
10983353|NCT00973349|FG010|Participant Flow|7.5_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
10983354|NCT00973349|FG011|Participant Flow|7.5_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
10983355|NCT00973349|FG012|Participant Flow|15 w/o MF59 (≥ 65 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
10983356|NCT00973349|FG013|Participant Flow|15_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
10983357|NCT00973349|FG014|Participant Flow|15_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
10983358|NCT00973349|FG015|Participant Flow|30 w/o MF59(≥ 65 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
10983359|NCT00973349|OG000|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
10983360|NCT00973349|OG001|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
10983361|NCT00973349|OG002|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
10983362|NCT00973349|OG003|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
10983363|NCT00973349|OG004|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
10983364|NCT00973349|OG005|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
10983365|NCT00973349|OG006|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
10983366|NCT00973349|OG007|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
10983367|NCT00973349|EG000|Reported Event|3.75_(50)MF59|50% of MF59 with the lowest amount of A/H1N1 antigen
10983368|NCT00973349|EG001|Reported Event|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1
10983369|NCT00973349|EG002|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
10983370|NCT00973349|EG003|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
10983371|NCT00973349|EG004|Reported Event|15 w/o MF59|1 dose of 15 µg A/H1N1
10983372|NCT00973349|EG005|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
10983373|NCT00973349|EG006|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
10983374|NCT00973349|EG007|Reported Event|30 w/o MF59|1 dose of 30 µg A/H1N1
10983375|NCT00973349|EG008|Reported Event|3.75_(50)MF59 (Above 65 Yrs)|50% of MF59 with the lowest amount of A/H1N1 antigen
10983376|NCT00973349|EG009|Reported Event|7.5 w/o MF59 (≥65 Yrs)|1 dose of 7.5 µg A/H1N1
10983377|NCT00973349|EG010|Reported Event|7.5_(50)MF59 (≥65 Yrs)|50% of MF59 with 7.5 µg A/H1N1 antigen
10983378|NCT00973349|EG011|Reported Event|7.5_(100)MF59 (≥65 Yrs)|100% of MF59 with 7.5 µg A/H1N1 antigen
10983379|NCT00973349|EG012|Reported Event|15 w/o MF59 (≥ 65 Yrs)|1 dose of 15 µg A/H1N1
10848894|NCT00292318|EG000|Reported Event|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
10983380|NCT00973349|EG013|Reported Event|15_(50)MF59 (≥65 Yrs)|50% of MF59 with 15 µg A/H1N1 antigen
10983381|NCT00973349|EG014|Reported Event|15_(100)MF59 (≥65 Yrs)|100% of MF59 with 15 µg A/H1N1 antigen
10983382|NCT00973349|EG015|Reported Event|30 w/o MF59 (≥65 Yrs)|1 dose of 30 µg A/H1N1
10983383|NCT00973362|BG000|Baseline|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
10983384|NCT00973362|BG001|Baseline|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
10983385|NCT00973362|BG002|Baseline|Total|Total of all reporting groups
10983386|NCT00973362|FG000|Participant Flow|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
10983387|NCT00973362|FG001|Participant Flow|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).~There is no follow-up period for the ASC-US Arm of the study, only for the Adjunct ARM has a three (3) year follow-up period."
10983388|NCT00973362|OG000|Outcome|APTIMA HPV Assay|"The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
10983389|NCT00973362|OG000|Outcome|FDA-Approved DNA Test|A FDA-Approved HPV DNA Test is the comparator assay,
10983390|NCT00973362|OG000|Outcome|APTIMA HPV Assay|APTIMA HPV Assay Performed on the Tigris System
10983391|NCT00973362|OG001|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
10983392|NCT00973362|OG000|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
10983393|NCT00973362|EG000|Reported Event|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
10983394|NCT00973362|EG001|Reported Event|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
10983395|NCT00973479|BG000|Baseline|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
10983396|NCT00973479|BG001|Baseline|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
10983397|NCT00973479|BG002|Baseline|Total|Total of all reporting groups
10983398|NCT00973479|FG000|Participant Flow|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
10983399|NCT00973479|FG001|Participant Flow|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
10983400|NCT00973479|OG000|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
10983401|NCT00973479|OG001|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
10983402|NCT00973479|EG000|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16|Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
10983403|NCT00973479|EG001|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24|Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
10983404|NCT00973479|EG002|Reported Event|Golimumab 2 mg/kg + MTX|Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.
10983405|NCT00973479|EG003|Reported Event|Combined Golimumab|Participants in the reporting groups: Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
10983406|NCT00973622|BG000|Baseline|Smokers|
10983407|NCT00973622|BG001|Baseline|Nonsmokers|
10983408|NCT00973622|BG002|Baseline|Total|Total of all reporting groups
10983409|NCT00973622|FG000|Participant Flow|Smokers|Smokers were healthy adults between the ages of 19 and 55 years who had no intention of quitting smoking before the end of the study.
10983410|NCT00973622|FG001|Participant Flow|Non-smokers|Healthy adult non-smokers who were between the ages of aged 19-55 years.
10983411|NCT00973622|OG000|Outcome|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
10983412|NCT00973622|OG001|Outcome|Non-smokers|Healthy adult non-smokers aged 19-55
10983413|NCT00973622|EG000|Reported Event|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
10874702|NCT00434434|EG000|Reported Event|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874703|NCT00434434|EG001|Reported Event|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874704|NCT00434434|EG002|Reported Event|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
10874705|NCT00434512|BG000|Baseline|SB732461 Non-adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874706|NCT00434512|BG001|Baseline|SB732461 Non-adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874707|NCT00434512|BG002|Baseline|SB732461 Non-adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874708|NCT00434512|BG003|Baseline|SB732461 adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874709|NCT00434512|BG004|Baseline|SB732461 adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874710|NCT00434512|BG005|Baseline|SB732461 adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874711|NCT00434512|BG006|Baseline|Total|Total of all reporting groups
10874712|NCT00434512|FG000|Participant Flow|SB732461 Non-adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874713|NCT00434512|FG001|Participant Flow|SB732461 Non-adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874714|NCT00434512|FG002|Participant Flow|SB732461 Non-adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874715|NCT00434512|FG003|Participant Flow|SB732461 adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874716|NCT00434512|FG004|Participant Flow|SB732461 adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874717|NCT00434512|FG005|Participant Flow|SB732461 adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874718|NCT00434512|OG000|Outcome|SB732461 Non-adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874719|NCT00434512|OG001|Outcome|SB732461 Non-adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874720|NCT00434512|OG002|Outcome|SB732461 Non-adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874721|NCT00434512|OG003|Outcome|SB732461 adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874722|NCT00434512|OG004|Outcome|SB732461 adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874723|NCT00434512|OG005|Outcome|SB732461 adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874724|NCT00434512|OG001|Outcome|SB732461 adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874725|NCT00434512|OG002|Outcome|SB732461 Non-adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874726|NCT00434512|OG003|Outcome|SB732461 adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874727|NCT00434512|OG004|Outcome|SB732461 Non-adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874728|NCT00434512|EG000|Reported Event|SB732461 Non-adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874729|NCT00434512|EG001|Reported Event|SB732461 Non-adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874730|NCT00434512|EG002|Reported Event|SB732461 Non-adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10983414|NCT00973622|EG001|Reported Event|Non-smokers|Healthy adult non-smokers aged 19-55
10983415|NCT00973674|BG000|Baseline|Premarin IV|"Patients randomized to receive a single dose of 0.5 mg/kg Premarin® IV~Premarin IV: One time dose of Premarin IV"
10983416|NCT00973674|BG001|Baseline|Placebo|"Patients randomized to receive a single dose of placebo IV. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with traumatic brain injury.~Placebo: One time dose of Placebo"
10983417|NCT00973674|BG002|Baseline|Total|Total of all reporting groups
10983418|NCT00973674|FG000|Participant Flow|Premarin IV|"Patients randomized to receive a single dose of 0.5 mg/kg Premarin® IV~Premarin IV: One time dose of Premarin IV"
10983419|NCT00973674|FG001|Participant Flow|Placebo|"Patients randomized to receive a single dose of placebo IV. Due to the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with traumatic brain injury.~Placebo: One time dose of Placebo"
10983420|NCT00973674|OG000|Outcome|Premarin IV|"Patients randomized to receive a single dose of 0.5 mg/kg Premarin® IV~Premarin IV: One time dose of Premarin IV"
10983421|NCT00973674|OG001|Outcome|Placebo|"Patients randomized to receive a single dose of placebo IV. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with traumatic brain injury.~Placebo: One time dose of Placebo"
10983422|NCT00973674|OG001|Outcome|Placebo|"Patients randomized to receive a single dose of placebo IV. Due to the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with traumatic brain injury.~Placebo: One time dose of Placebo"
10983423|NCT00973674|EG000|Reported Event|Premarin IV|"Patients randomized to receive a single dose of 0.5 mg/kg Premarin® IV~Premarin IV: One time dose of Premarin IV"
10983424|NCT00973674|EG001|Reported Event|Placebo|"Patients randomized to receive a single dose of placebo IV. Due to the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with traumatic brain injury.~Placebo: One time dose of Placebo"
10983425|NCT00973700|BG000|Baseline|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
10983426|NCT00973700|BG001|Baseline|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
10983427|NCT00973700|BG002|Baseline|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
10983428|NCT00973700|BG003|Baseline|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
10983429|NCT00973700|BG004|Baseline|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
10983430|NCT00973700|BG005|Baseline|Total|Total of all reporting groups
10983431|NCT00973700|FG000|Participant Flow|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
10983432|NCT00973700|FG001|Participant Flow|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
10983433|NCT00973700|FG002|Participant Flow|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
10983434|NCT00973700|FG003|Participant Flow|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
10983435|NCT00973700|FG004|Participant Flow|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
10983436|NCT00973700|OG000|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
10983437|NCT00973700|OG000|Outcome|15_1_22|A/H1N1 on study days 1 and 22
10983438|NCT00973700|OG000|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
10983439|NCT00973700|OG001|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; two doses on day 1
10983440|NCT00973700|OG002|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
10983441|NCT00973700|OG003|Outcome|15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
10983442|NCT00973700|OG004|Outcome|2x15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
10983443|NCT00973700|OG000|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
10983444|NCT00973700|OG001|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
10983445|NCT00973700|OG002|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
10983446|NCT00973700|OG001|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
10983447|NCT00973700|OG002|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
10983448|NCT00973700|OG003|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
10983449|NCT00973700|OG004|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
10983450|NCT00973700|EG000|Reported Event|2x7.5adj (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; two doses on day 1
10983451|NCT00973700|EG001|Reported Event|7.5adj_1_8 (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
10983452|NCT00973700|EG002|Reported Event|7.5adj_1_22 (18-64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
10983453|NCT00973700|EG003|Reported Event|15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
10983454|NCT00973700|EG004|Reported Event|2x15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
10983455|NCT00973700|EG005|Reported Event|7.5adj_1_22 (9 to 17 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
10983456|NCT00973700|EG006|Reported Event|15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
10983457|NCT00973700|EG007|Reported Event|2x15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
10983458|NCT00973700|EG008|Reported Event|7.5adj_1_22 (3 to <9 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
10983459|NCT00973700|EG009|Reported Event|15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
10983460|NCT00973700|EG010|Reported Event|2x15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
10983461|NCT00973739|BG000|Baseline|Lapatinib|Lapatinib will be administered
10983462|NCT00973739|FG000|Participant Flow|Lapatinib|Lapatinib will be administered
10983463|NCT00973739|OG000|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
10983464|NCT00973739|EG000|Reported Event|Lapatinib|Lapatinib will be administered
10983465|NCT00973752|BG000|Baseline|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
10983466|NCT00973752|FG000|Participant Flow|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS (central nervous system), Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
10983467|NCT00973752|OG000|Outcome|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
10983468|NCT00973752|EG000|Reported Event|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
10983469|NCT00973765|BG000|Baseline|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
10983470|NCT00973765|BG001|Baseline|Placebo|Matched placebo 2 pills po BID x 7 days
10983471|NCT00973765|BG002|Baseline|Total|Total of all reporting groups
10983472|NCT00973765|FG000|Participant Flow|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
10983473|NCT00973765|FG001|Participant Flow|Placebo|Matched placebo 2 pills po BID x 7 days
10983474|NCT00973765|OG000|Outcome|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
10983475|NCT00973765|OG001|Outcome|Placebo|Matched placebo 2 pills po BID x 7 days
10983476|NCT00973765|EG000|Reported Event|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
10983477|NCT00973765|EG001|Reported Event|Placebo|Matched placebo 2 pills po BID x 7 days
11007147|NCT01089556|EG000|Reported Event|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
11007148|NCT01089556|EG001|Reported Event|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
11007149|NCT01089556|EG002|Reported Event|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
11007150|NCT01089556|EG003|Reported Event|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
11007151|NCT01089556|EG004|Reported Event|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
10983478|NCT00973921|BG000|Baseline|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
10983479|NCT00973921|FG000|Participant Flow|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
10983480|NCT00973921|OG000|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
10983481|NCT00973921|EG000|Reported Event|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
10983482|NCT00973973|BG000|Baseline|Placebo|Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.
10983483|NCT00973973|BG001|Baseline|Elagolix 150 mg|Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
10983484|NCT00973973|BG002|Baseline|Total|Total of all reporting groups
10983485|NCT00973973|FG000|Participant Flow|Placebo|Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.
10983486|NCT00973973|FG001|Participant Flow|Elagolix 150 mg|Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
10983487|NCT00973973|OG000|Outcome|Placebo|Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.
10983488|NCT00973973|OG001|Outcome|Elagolix 150 mg|Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
10983489|NCT00973973|EG000|Reported Event|Placebo|Participants received placebo orally once a day for 8 weeks during the double-blind treatment period.
10983490|NCT00973973|EG001|Reported Event|Elagolix|"Participants initially randomized to elagolix received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.~Participants originally randomized to placebo were switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period."
10983491|NCT00974051|BG000|Baseline|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
10983492|NCT00974051|FG000|Participant Flow|Control First, Then Terbutaline, Then 20% Basal Reduction|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
10983493|NCT00974051|FG001|Participant Flow|Terbutaline First, Then 20% Basal Reduction, Then Control|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
10983494|NCT00974051|FG002|Participant Flow|20% Basal Reduction First, Then Control, Then Terbutaline|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
10983495|NCT00974051|OG000|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
10983496|NCT00974051|OG001|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
10983497|NCT00974051|OG002|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
10983498|NCT00974051|EG000|Reported Event|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
10983499|NCT00974051|EG001|Reported Event|Control Arm|during control intervention night
10983500|NCT00974051|EG002|Reported Event|Terbutaline Arm|During turbutaline intervention night
10983501|NCT00974051|EG003|Reported Event|20% Basal Reduction Arm|During 20% basal reduction night
10983502|NCT00974090|BG000|Baseline|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
10983503|NCT00974090|BG001|Baseline|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
10983504|NCT00974090|BG002|Baseline|Total|Total of all reporting groups
10983505|NCT00974090|FG000|Participant Flow|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
10983506|NCT00974090|FG001|Participant Flow|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
10983507|NCT00974090|OG000|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
10983508|NCT00974090|OG001|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
10983509|NCT00974090|EG000|Reported Event|Placebo/Teneli + SU (Data Through Week 12)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.~MedDRA 13.0"
10983510|NCT00974090|EG001|Reported Event|Teneli/Teneli + SU (Data Through Week 12)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.~MedDRA 13.0"
10983511|NCT00974090|EG002|Reported Event|Placebo/Teneli + SU (Data From Week 12 to Week 52)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.~MedDRA 13.1"
10983512|NCT00974090|EG003|Reported Event|Teneli/Teneli + SU (Data Through Week 52)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.~MedDRA 13.1"
10983513|NCT00974142|BG000|Baseline|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
10983514|NCT00974142|BG001|Baseline|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
10983515|NCT00974142|BG002|Baseline|Total|Total of all reporting groups
10983516|NCT00974142|FG000|Participant Flow|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
10983517|NCT00974142|FG001|Participant Flow|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
10983518|NCT00974142|OG000|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
10983519|NCT00974142|OG001|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
10983520|NCT00974142|EG000|Reported Event|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
10983521|NCT00974142|EG001|Reported Event|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
10983522|NCT00974220|BG000|Baseline|Placebo - Fentanyl (Order)|nebulized saline placebo in period 1, nebulized fentanyl citrate in period 2.
10983523|NCT00974220|BG001|Baseline|Fentanyl - Placebo (Order)|nebulized fentanyl citrate in period 1, nebulized saline placebo in period 2.
10983524|NCT00974220|BG002|Baseline|Total|Total of all reporting groups
10983525|NCT00974220|FG000|Participant Flow|Placebo - Fentanyl (Order)|nebulized 0.9% saline placebo in period 1, nebulized fentanyl citrate 50mcg in period 2
10983526|NCT00974220|FG001|Participant Flow|Fentanyl - Placebo (Order)|nebulized fentanyl citrate (50 mcg) in period 1, nebulized 0.9% saline placebo in period 2
10983527|NCT00974220|OG000|Outcome|Placebo|nebulized 0.9% saline placebo
10983528|NCT00974220|OG001|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
10983529|NCT00974220|EG000|Reported Event|Placebo|nebulized 0.9% saline placebo
10983530|NCT00974220|EG001|Reported Event|Fentanyl|nebulized fentanyl citrate (50 mcg)
10983531|NCT00974233|BG000|Baseline|Overall Study Population|Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen).
10983532|NCT00974233|FG000|Participant Flow|Induction Chemoimmunotherapy + Maintenance Lenalidomide|Induction therapy: Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles. Maintenance therapy: Lenalidomide 5-10 mg orally continuously of each 28-day cycles for total of 12 treatment cycles.
10983533|NCT00974233|OG000|Outcome|Induction/Maintenance Chemotherapy|"Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy~Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles~Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles~Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol."
10983534|NCT00974233|OG000|Outcome|Complete Response (CR)|Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow.
10983535|NCT00974233|OG001|Outcome|Partial Response (PR)|Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count.
10983536|NCT00974233|OG002|Outcome|Stable Disease|Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response.
10983537|NCT00974233|OG003|Outcome|Overall Response Rate|Includes complete and partial responses.
10983538|NCT00974233|OG000|Outcome|Induction Chemoimmunotherapy|Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles.
10983539|NCT00974233|OG001|Outcome|Maintenance|Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment.
10983540|NCT00974233|OG000|Outcome|Overall Study Population|Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen).
10983541|NCT00974233|EG000|Reported Event|Induction Chemoimmunotherapy|Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles.
11007152|NCT01089556|EG005|Reported Event|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
10983542|NCT00974233|EG001|Reported Event|Maintenance|Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment.
10983543|NCT00974246|BG000|Baseline|Baseline Characteristics|Nursing Home residents with either a confirmed diagnosis of COPD or an FEV1/FVC ratio <0.7 or in treatment with anticholinergic drugs.
10983544|NCT00974246|FG000|Participant Flow|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
10983545|NCT00974246|OG000|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
10983546|NCT00974246|OG000|Outcome|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
10983547|NCT00974246|EG000|Reported Event|Adverse Events|All enrolled subjects.
10983548|NCT00974259|BG000|Baseline|pBrO2 and ICP Management|"Treatment protocol based on pBrO2 and ICP values.~Management protocol based on pBrO2 and ICP values.: For patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (> 20 mm Hg) or pBrO2 (< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time."
10983549|NCT00974259|BG001|Baseline|ICP Management|"Treatment protocol based on ICP values only.~Management protocol based on ICP values only.: For the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant."
10983550|NCT00974259|BG002|Baseline|Total|Total of all reporting groups
10983551|NCT00974259|FG000|Participant Flow|pBrO2 and ICP Management|"Treatment protocol based on pBrO2 and ICP values.~Management protocol based on pBrO2 and ICP values.: For patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (> 20 mm Hg) or pBrO2 (< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time."
10983552|NCT00974259|FG001|Participant Flow|ICP Management|"Treatment protocol based on ICP values only.~Management protocol based on ICP values only.: For the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant."
10983553|NCT00974259|OG000|Outcome|pBrO2 and ICP Management|"Treatment protocol based on pBrO2 and ICP values.~Management protocol based on pBrO2 and ICP values.: For patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (> 20 mm Hg) or pBrO2 (< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time."
10983554|NCT00974259|OG001|Outcome|ICP Management|"Treatment protocol based on ICP values only.~Management protocol based on ICP values only.: For the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant."
10983555|NCT00974259|EG000|Reported Event|pBrO2 and ICP Management|"Treatment protocol based on pBrO2 and ICP values.~Management protocol based on pBrO2 and ICP values.: For patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (> 20 mm Hg) or pBrO2 (< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time."
10983556|NCT00974259|EG001|Reported Event|ICP Management|"Treatment protocol based on ICP values only.~Management protocol based on ICP values only.: For the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant."
10983557|NCT00974311|BG000|Baseline|Enzalutamide|In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
10983558|NCT00974311|BG001|Baseline|Placebo|In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
10983559|NCT00974311|BG002|Baseline|Total|Total of all reporting groups
11007153|NCT01089569|BG000|Baseline|Exenatide|"5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study~Exenatide: refer to Arm detail"
10983560|NCT00974311|FG000|Participant Flow|Enzalutamide|In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
10983561|NCT00974311|FG001|Participant Flow|Placebo|In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
10983562|NCT00974311|OG000|Outcome|Enzalutamide|In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
10983563|NCT00974311|OG001|Outcome|Placebo|In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
10983564|NCT00974311|OG001|Outcome|Placebo: DB Phase|In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).
10983565|NCT00974311|OG002|Outcome|Placebo (DB) /Enzalutamide 160 mg (OLE) Phase|Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).
10983566|NCT00974311|EG000|Reported Event|Enzalutamide: DB + OLE Phase|In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal.
10983567|NCT00974311|EG001|Reported Event|Placebo: DB Phase|In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).
10983568|NCT00974311|EG002|Reported Event|Placebo (DB) /Enzalutamide 160 mg (OLE) Phase|Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).
10983569|NCT00974350|BG000|Baseline|Group 1: SABER-Bupivacaine|"2.5 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once"
10983570|NCT00974350|BG001|Baseline|Group 2: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once"
10983571|NCT00974350|BG002|Baseline|Group 3: SABER-Placebo|"2.5 mL or 5.0 mL SABER-Placebo/Once~SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once"
10983572|NCT00974350|BG003|Baseline|Total|Total of all reporting groups
10983573|NCT00974350|FG000|Participant Flow|Group 1: SABER-Bupivacaine|"2.5 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once"
10983574|NCT00974350|FG001|Participant Flow|Group 2: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once"
10983575|NCT00974350|FG002|Participant Flow|Group 3: SABER-Placebo|"2.5 mL or 5.0 mL SABER-Placebo/Once~SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once (SABER-Placebo 2.5 mL or 5.0 mL, as randomly assigned)"
10983576|NCT00974350|OG000|Outcome|Group 1: SABER-Bupivacaine|"2.5 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once"
10983577|NCT00974350|OG001|Outcome|Group 2: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine /Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once"
10983578|NCT00974350|OG002|Outcome|Group 3: SABER-Placebo|"2.5 mL or 5.0 mL SABER-Placebo/Once~SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once"
10983579|NCT00974350|OG001|Outcome|Group 2: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once"
10983580|NCT00974350|EG000|Reported Event|Group 1: SABER-Bupivacaine|"2.5 mL SABER-Bupivacaine /Once~SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once"
10983581|NCT00974350|EG001|Reported Event|Group 2: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine /Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine (660 mg) /Once"
10983582|NCT00974350|EG002|Reported Event|Group 3: SABER-Placebo|"2.5 mL or 5.0 mL SABER-Placebo/Once~SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once"
10983583|NCT00974363|BG000|Baseline|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
10983584|NCT00974363|BG001|Baseline|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
10983585|NCT00974363|BG002|Baseline|Total|Total of all reporting groups
11007154|NCT01089569|BG001|Baseline|Insulin Glargine|".1 unit per kg to start, titrated based on Continuous Glucose Monitoring results~Insulin Glargine: refer to Arm detail"
10983586|NCT00974363|FG000|Participant Flow|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
10983587|NCT00974363|FG001|Participant Flow|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
10983588|NCT00974363|OG000|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
10983589|NCT00974363|OG001|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
10983590|NCT00974363|EG000|Reported Event|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
10983591|NCT00974363|EG001|Reported Event|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
10983592|NCT00974376|BG000|Baseline|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
10983593|NCT00974376|BG001|Baseline|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
10983594|NCT00974376|BG002|Baseline|Total|Total of all reporting groups
10983595|NCT00974376|FG000|Participant Flow|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
10983596|NCT00974376|FG001|Participant Flow|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
10983597|NCT00974376|OG000|Outcome|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
10983598|NCT00974376|OG001|Outcome|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
10983599|NCT00974376|EG000|Reported Event|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
10983600|NCT00974376|EG001|Reported Event|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
10983601|NCT00974480|BG000|Baseline|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
10983602|NCT00974480|BG001|Baseline|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
10983603|NCT00974480|BG002|Baseline|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
10983604|NCT00974480|BG003|Baseline|Total|Total of all reporting groups
10983605|NCT00974480|FG000|Participant Flow|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
10983606|NCT00974480|FG001|Participant Flow|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
10983607|NCT00974480|FG002|Participant Flow|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
10983608|NCT00974480|OG000|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
10983609|NCT00974480|OG001|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
10983610|NCT00974480|OG002|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
10983611|NCT00974480|OG000|Outcome|Redermic - Assessor 1|Cream applied twice a day every day, morning and evening for 24 weeks.
11007155|NCT01089569|BG002|Baseline|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
11007156|NCT01089569|BG003|Baseline|Total|Total of all reporting groups
10983612|NCT00974480|OG001|Outcome|Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
10983613|NCT00974480|OG002|Outcome|Combination of Redermic and Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
10983614|NCT00974480|OG003|Outcome|Redermic - Assessor 2|Cream applied twice a day every day, morning and evening for 24 weeks.
10983615|NCT00974480|OG004|Outcome|Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
10983616|NCT00974480|OG005|Outcome|Combination of Redermic and Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
10983617|NCT00974480|EG000|Reported Event|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
10983618|NCT00974480|EG001|Reported Event|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
10983619|NCT00974480|EG002|Reported Event|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
10983620|NCT00974493|BG000|Baseline|Oral Antibiotics|"Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
10983621|NCT00974493|BG001|Baseline|Intravenous Antibiotics|"Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
10983622|NCT00974493|BG002|Baseline|Total|Total of all reporting groups
10983623|NCT00974493|FG000|Participant Flow|Oral Antibiotics|"Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
10983624|NCT00974493|FG001|Participant Flow|Intravenous Antibiotics|"Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
10983625|NCT00974493|OG000|Outcome|Oral Antibiotics|"Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
10983626|NCT00974493|OG001|Outcome|Intravenous Antibiotics|"Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
10983627|NCT00974493|EG000|Reported Event|Oral Antibiotics|"Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
10983628|NCT00974493|EG001|Reported Event|Intravenous Antibiotics|"Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
10983629|NCT00974675|BG000|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983630|NCT00974675|BG001|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983631|NCT00974675|BG002|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983632|NCT00974675|BG003|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983633|NCT00974675|BG004|Baseline|Total|Total of all reporting groups
10983634|NCT00974675|FG000|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983635|NCT00974675|FG001|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983636|NCT00974675|FG002|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983637|NCT00974675|FG003|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983638|NCT00974675|OG000|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983639|NCT00974675|OG001|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983640|NCT00974675|OG002|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983641|NCT00974675|OG003|Outcome|Placebp|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983642|NCT00974675|EG000|Reported Event|1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983643|NCT00974675|EG001|Reported Event|5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983644|NCT00974675|EG002|Reported Event|10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983645|NCT00974675|EG003|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
10983646|NCT00974818|BG000|Baseline|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
10983647|NCT00974818|BG001|Baseline|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
10983648|NCT00974818|BG002|Baseline|Total|Total of all reporting groups
10983649|NCT00974818|FG000|Participant Flow|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
10983650|NCT00974818|FG001|Participant Flow|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
10983651|NCT00974818|OG000|Outcome|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
10983652|NCT00974818|OG001|Outcome|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
10983653|NCT00974818|EG000|Reported Event|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
10983654|NCT00974818|EG001|Reported Event|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
10983655|NCT00974974|BG000|Baseline|IPX066|Investigational product IPX066
10983656|NCT00974974|BG001|Baseline|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
10983657|NCT00974974|BG002|Baseline|Total|Total of all reporting groups
10983658|NCT00974974|FG000|Participant Flow|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
10983659|NCT00974974|FG001|Participant Flow|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
10983660|NCT00974974|OG000|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
10846318|NCT00274781|OG000|Outcome|ATO + GO|"Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m^2 D8 for 1 or 2 Cycles of 12 Weeks each~arsenic trioxide: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).~gemtuzumab ozogamicin: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion"
10983661|NCT00974974|OG001|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
10983662|NCT00974974|EG000|Reported Event|IPX066|Investigational product IPX066
10983663|NCT00974974|EG001|Reported Event|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
10983664|NCT00975000|BG000|Baseline|Placebo|Participants received placebo orally once daily for 52 weeks.
10983665|NCT00975000|BG001|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
10983666|NCT00975000|BG002|Baseline|Total|Total of all reporting groups
10983667|NCT00975000|FG000|Participant Flow|Placebo|Participants received placebo orally once daily for 52 weeks.
10983668|NCT00975000|FG001|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parathyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
10983669|NCT00975000|OG000|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
10983670|NCT00975000|OG001|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
10983671|NCT00975000|EG000|Reported Event|Placebo|Participants received placebo orally once daily for 52 weeks.
10983672|NCT00975000|EG001|Reported Event|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
10983673|NCT00975130|BG000|Baseline|GLM50-SC|Participants received 50 mg of golimumab subcutaneously once monthly for a period of 6 months. 3280 enrolled participants were included in the Efficacy-Evaluable population; baseline characteristics are presented for this population.
10983674|NCT00975130|FG000|Participant Flow|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months in Study Part 1.
10983675|NCT00975130|FG001|Participant Flow|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|Participants achieving good or moderate response but not in remission at the conclusion of Study Part 1 received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly.
10983676|NCT00975130|FG002|Participant Flow|SC-GLM50|Participants achieving good or moderate response but not in remission at the end of Study Part 1, received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
10983677|NCT00975130|OG000|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
10983678|NCT00975130|OG000|Outcome|IV-GLM2/SC-GLM50|Intravenous golimumab 2 mg/kg followed by subcutaneous golimumab 50 mg once monthly.
10983679|NCT00975130|OG001|Outcome|SC-GLM50|Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
10983680|NCT00975130|OG000|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
10846319|NCT00274781|OG000|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
10846320|NCT00274781|EG000|Reported Event|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
10983681|NCT00975130|OG000|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
10983682|NCT00975130|OG000|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched to subcutaneous golimumab~at a dose of 50 mg once monthly."
10983683|NCT00975130|OG001|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
10983684|NCT00975130|OG000|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|Participants received IV GLM at a dose of 2 mg/kg until remission is achieved at which time they were switched to SC GLM at a dose of 50 mg once monthly.
10983685|NCT00975130|EG000|Reported Event|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months.
10983686|NCT00975130|EG001|Reported Event|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab~at a dose of 50 mg once monthly."
10983687|NCT00975130|EG002|Reported Event|SC-GLM50|Participants received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
10983688|NCT00975143|BG000|Baseline|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
10983689|NCT00975143|BG001|Baseline|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
10983690|NCT00975143|BG002|Baseline|Total|Total of all reporting groups
10983691|NCT00975143|FG000|Participant Flow|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
10983692|NCT00975143|FG001|Participant Flow|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
10983693|NCT00975143|OG000|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
10983694|NCT00975143|OG001|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
10983695|NCT00975143|EG000|Reported Event|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
10983696|NCT00975143|EG001|Reported Event|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
10983697|NCT00975156|BG000|Baseline|Lokomat Intervention|
10983698|NCT00975156|BG001|Baseline|Standard of Care|Conventional physical therapy
10983699|NCT00975156|BG002|Baseline|Total|Total of all reporting groups
10983700|NCT00975156|FG000|Participant Flow|Lokomat Intervention|
10983701|NCT00975156|FG001|Participant Flow|Standard of Care|Conventional physical therapy
10983702|NCT00975156|OG000|Outcome|Lokomat Intervention 10-meter Walking Test (10mWT) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
10983703|NCT00975156|OG001|Outcome|Standard of Care 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
10983704|NCT00975156|OG002|Outcome|All Participants 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
11007157|NCT01089569|FG000|Participant Flow|Exenatide|5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
10983705|NCT00975156|OG000|Outcome|Lokomat Intervention 6 Minute Walking Distance (6MWD) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
10983706|NCT00975156|OG001|Outcome|Standard of Care 6MWD Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
10983707|NCT00975156|OG002|Outcome|All Participants 6MWD Outcome|Baseline, Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
10983708|NCT00975156|EG000|Reported Event|Lokomat Intervention|Robotic-assisted gait therapy
10983709|NCT00975156|EG001|Reported Event|Standard of Care|Conventional physical therapy
10983710|NCT00975195|BG000|Baseline|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
10983711|NCT00975195|BG001|Baseline|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
10983712|NCT00975195|BG002|Baseline|Total|Total of all reporting groups
10983713|NCT00975195|FG000|Participant Flow|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
10983714|NCT00975195|FG001|Participant Flow|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
10983715|NCT00975195|OG000|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
10983716|NCT00975195|OG001|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
10983717|NCT00975195|EG000|Reported Event|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
10983718|NCT00975195|EG001|Reported Event|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
10983719|NCT00975221|BG000|Baseline|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
10983720|NCT00975221|BG001|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
10983721|NCT00975221|BG002|Baseline|Total|Total of all reporting groups
10983722|NCT00975221|FG000|Participant Flow|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
10983723|NCT00975221|FG001|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
10874731|NCT00434512|EG003|Reported Event|SB732461 adjuvanted_LD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874732|NCT00434512|EG004|Reported Event|SB732461 adjuvanted_MD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874733|NCT00434512|EG005|Reported Event|SB732461 adjuvanted_HD Group|Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
10874734|NCT00434577|BG000|Baseline|GSK1437173A _LD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.
10874735|NCT00434577|BG001|Baseline|GSK1437173A _MD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874736|NCT00434577|BG002|Baseline|GSK1437173A _HD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874737|NCT00434577|BG003|Baseline|Placebo + GSK1437173A _HD Group|Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874738|NCT00434577|BG004|Baseline|GSK1437173A_MODIFIED GROUP|Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874739|NCT00434577|BG005|Baseline|Total|Total of all reporting groups
10874740|NCT00434577|FG000|Participant Flow|GSK1437173A _LD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.
10874741|NCT00434577|FG001|Participant Flow|GSK1437173A _MD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874742|NCT00434577|FG002|Participant Flow|GSK1437173A _HD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874743|NCT00434577|FG003|Participant Flow|Placebo + GSK1437173A _HD Group|Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874744|NCT00434577|FG004|Participant Flow|GSK1437173A_MODIFIED Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874745|NCT00434577|OG000|Outcome|GSK1437173A _LD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.
10874746|NCT00434577|OG001|Outcome|GSK1437173A _MD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874747|NCT00434577|OG002|Outcome|GSK1437173A _HD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874748|NCT00434577|OG003|Outcome|Placebo + GSK1437173A _HD Group|Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874749|NCT00434577|OG004|Outcome|GSK1437173A_MODIFIED Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874750|NCT00434577|EG000|Reported Event|GSK1437173A _LD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.
10874751|NCT00434577|EG001|Reported Event|GSK1437173A _MD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874752|NCT00434577|EG002|Reported Event|GSK1437173A _HD Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10983724|NCT00975221|OG000|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
10983725|NCT00975221|OG001|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
10983726|NCT00975221|EG000|Reported Event|Double-blind Phase: Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase.
10983727|NCT00975221|EG001|Reported Event|Double-blind Phase: Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week double-blind dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the double-blind efficacy assessment phase.
10983728|NCT00975221|EG002|Reported Event|Open-label Phase: Previous Placebo|Participants who received placebo during the double-blind phase (Weeks 1-28) then received cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
10983729|NCT00975221|EG003|Reported Event|Open-label Phase: Previous Cinacalcet|Participants who received cinacalcet during the double-blind phase continued to receive cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
10983730|NCT00975286|BG000|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10983731|NCT00975286|BG001|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10983732|NCT00975286|BG002|Baseline|Total|Total of all reporting groups
10983733|NCT00975286|FG000|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10983734|NCT00975286|FG001|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10983735|NCT00975286|OG000|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
10983736|NCT00975286|OG001|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
10983737|NCT00975286|EG000|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
10983738|NCT00975286|EG001|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
10983739|NCT00975416|BG000|Baseline|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
10983740|NCT00975416|BG001|Baseline|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Intranasal Placebo given in the context of cognitive behavioral therapy"
10983741|NCT00975416|BG002|Baseline|Total|Total of all reporting groups
10983742|NCT00975416|FG000|Participant Flow|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
10983743|NCT00975416|FG001|Participant Flow|Inpatient Cocaine Placebo|Placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Placebo given in the context of cognitive behavioral therapy
10983744|NCT00975416|OG000|Outcome|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
10983745|NCT00975416|OG001|Outcome|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Intranasal placebo given in the context of cognitive behavioral therapy"
10983746|NCT00975416|EG000|Reported Event|Methadone|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
10983747|NCT00975416|EG001|Reported Event|Outpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
10983748|NCT00975416|EG002|Reported Event|Inpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
10983749|NCT00975481|BG000|Baseline|Entire Study Population|Includes participants randomized to receive placebo first, alprazolam 1 mg first, alprazolam 3 mg first, dimebon 20 mg first, dimebon 40 mg first and dimebon 60 mg first.
11007158|NCT01089569|FG001|Participant Flow|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
11007159|NCT01089569|FG002|Participant Flow|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
11007160|NCT01089569|OG000|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
10874753|NCT00434577|EG003|Reported Event|Placebo + GSK1437173A _HD Group|Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874754|NCT00434577|EG004|Reported Event|Placebo Group|Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
10874755|NCT00434642|BG000|Baseline|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
10874756|NCT00434642|BG001|Baseline|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
10874757|NCT00434642|BG002|Baseline|Total|Total of all reporting groups
10874758|NCT00434642|FG000|Participant Flow|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
10874759|NCT00434642|FG001|Participant Flow|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
10874760|NCT00434642|OG000|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
10874761|NCT00434642|OG001|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
10874762|NCT00434642|EG000|Reported Event|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
10874763|NCT00434642|EG001|Reported Event|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
10874764|NCT00434759|BG000|Baseline|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
10874765|NCT00434759|BG001|Baseline|Standardtherapy|standard therapy (therapist-guided intervention only)
10874766|NCT00434759|BG002|Baseline|Total|Total of all reporting groups
10874767|NCT00434759|FG000|Participant Flow|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
10874768|NCT00434759|FG001|Participant Flow|Standardtherapy|standard therapy (therapist-guided intervention only)
10874769|NCT00434759|OG000|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
10874770|NCT00434759|OG001|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only; 16 sessions)
10874771|NCT00434759|OG000|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
10874772|NCT00434759|OG001|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
10874773|NCT00434759|EG000|Reported Event|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
10874774|NCT00434759|EG001|Reported Event|Standardtherapy|standard therapy (therapist-guided intervention only)
10874775|NCT00434876|BG000|Baseline|Quetiapine|Quetiapine XR
10874776|NCT00434876|BG001|Baseline|Placebo|Placebo
11007161|NCT01089569|OG001|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
10874777|NCT00434876|BG002|Baseline|Total|Total of all reporting groups
10874778|NCT00434876|FG000|Participant Flow|Quetiapine XR|The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
10874779|NCT00434876|FG001|Participant Flow|Placebo|The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
10874780|NCT00434876|OG000|Outcome|Quetiapine XR|Quetiapine XR
10874781|NCT00434876|OG001|Outcome|Placebo|Placebo
10874782|NCT00434876|EG000|Reported Event|Quetiapine|Quetiapine XR
10874783|NCT00434876|EG001|Reported Event|Placebo|Placebo
10874784|NCT00434954|BG000|Baseline|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
10874785|NCT00434954|BG001|Baseline|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
10874786|NCT00434954|BG002|Baseline|Total|Total of all reporting groups
10874787|NCT00434954|FG000|Participant Flow|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
10874788|NCT00434954|FG001|Participant Flow|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
10874789|NCT00434954|OG000|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
10874790|NCT00434954|OG001|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
10874791|NCT00434954|EG000|Reported Event|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
10874792|NCT00434954|EG001|Reported Event|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
10874793|NCT00434967|BG000|Baseline|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
10874794|NCT00434967|BG001|Baseline|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
10874795|NCT00434967|BG002|Baseline|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
10874796|NCT00434967|BG003|Baseline|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
10874797|NCT00434967|BG004|Baseline|Total|Total of all reporting groups
10874798|NCT00434967|FG000|Participant Flow|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
10874799|NCT00434967|FG001|Participant Flow|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
10874800|NCT00434967|FG002|Participant Flow|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
10874801|NCT00434967|FG003|Participant Flow|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
10874802|NCT00434967|OG000|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
10874803|NCT00434967|OG001|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
10874804|NCT00434967|OG002|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
10874805|NCT00434967|OG003|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
10874806|NCT00434967|EG000|Reported Event|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
10874807|NCT00434967|EG001|Reported Event|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
10983750|NCT00975481|FG000|Participant Flow|PBO, ALP 1mg, DIM 60 mg, ALP 3 mg, DIM 40 mg, DIM 20 mg|Placebo (PBO) matched to 3 alprazolam (ALP) capsules and placebo matched to 3 dimebon (DIM) tablets on Day 1 in the first intervention period; followed by alprazolam 1 milligram (mg) capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in fourth intervention period; then dimebon 40 mg tablets and placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
10983751|NCT00975481|FG001|Participant Flow|ALP 1 mg, ALP 3 mg, PBO, DIM 20 mg, DIM 60 mg, DIM 40 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
10983752|NCT00975481|FG002|Participant Flow|ALP 3 mg, DIM 20 mg, ALP 1 mg, DIM 40 mg, PBO, DIM 60 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fourth interventional period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of 7 days was maintained between each dose.
10983753|NCT00975481|FG003|Participant Flow|DIM 20 mg, DIM 40 mg, ALP 3 mg, DIM 60 mg, ALP 1 mg, PBO|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then alprazolam 1mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
10983754|NCT00975481|FG004|Participant Flow|DIM 40 mg, DIM 60 mg, DIM 20 mg, PBO, ALP 3 mg, ALP 1 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
10983755|NCT00975481|FG005|Participant Flow|DIM 60 mg, PBO, DIM 40 mg, ALP 1mg, DIM 20 mg, ALP 3 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention group; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
10983756|NCT00975481|OG000|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
10983757|NCT00975481|OG001|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
10983758|NCT00975481|OG002|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
10983759|NCT00975481|OG003|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
10983760|NCT00975481|OG004|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
10983761|NCT00975481|OG005|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
10983762|NCT00975481|OG004|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to 1 dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
10983763|NCT00975481|OG005|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
10874808|NCT00434967|EG002|Reported Event|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
10874809|NCT00434967|EG003|Reported Event|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
10874810|NCT00434993|BG000|Baseline|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
10874811|NCT00434993|BG001|Baseline|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
10874812|NCT00434993|BG002|Baseline|Total|Total of all reporting groups
10874813|NCT00434993|FG000|Participant Flow|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
10874814|NCT00434993|FG001|Participant Flow|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
10874815|NCT00434993|OG000|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
10874816|NCT00434993|OG001|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
10874817|NCT00434993|EG000|Reported Event|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
10874818|NCT00434993|EG001|Reported Event|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
10874819|NCT00435019|BG000|Baseline|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
10874820|NCT00435019|BG001|Baseline|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
10874821|NCT00435019|BG002|Baseline|Total|Total of all reporting groups
10874822|NCT00435019|FG000|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
10874823|NCT00435019|FG001|Participant Flow|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
10874824|NCT00435019|OG000|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
10874825|NCT00435019|OG001|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
10874826|NCT00435019|EG000|Reported Event|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
10874827|NCT00435019|EG001|Reported Event|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
10874828|NCT00435045|BG000|Baseline|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
10874829|NCT00435045|BG001|Baseline|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
10874830|NCT00435045|BG002|Baseline|Total|Total of all reporting groups
10874831|NCT00435045|FG000|Participant Flow|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
10874832|NCT00435045|FG001|Participant Flow|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
10874833|NCT00435045|OG000|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
10874834|NCT00435045|OG001|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
10874835|NCT00435045|EG000|Reported Event|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
10874836|NCT00435045|EG001|Reported Event|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
10874837|NCT00435162|BG000|Baseline|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
10874838|NCT00435162|BG001|Baseline|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
10874839|NCT00435162|BG002|Baseline|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
10874840|NCT00435162|BG003|Baseline|Total|Total of all reporting groups
10874841|NCT00435162|FG000|Participant Flow|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
10874842|NCT00435162|FG001|Participant Flow|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then placebo
10874843|NCT00435162|FG002|Participant Flow|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
10874844|NCT00435162|FG003|Participant Flow|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then placebo
10874845|NCT00435162|FG004|Participant Flow|High Dose in Both Periods|Valsartan 1.0 mg/kg, then placebo
10874846|NCT00435162|FG005|Participant Flow|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then placebo
10874847|NCT00435162|OG000|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
10874848|NCT00435162|OG001|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
10874849|NCT00435162|OG002|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
10874850|NCT00435162|OG000|Outcome|Valsartan|pooled across all dosage levels
10874851|NCT00435162|OG001|Outcome|Placebo|
10874852|NCT00435162|EG000|Reported Event|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
10874853|NCT00435162|EG001|Reported Event|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then Placebo
10874854|NCT00435162|EG002|Reported Event|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
10874855|NCT00435162|EG003|Reported Event|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then Placebo
10874856|NCT00435162|EG004|Reported Event|High Dose in Both Periods|Valsartan 4.0 mg/kg in both periods
10874857|NCT00435162|EG005|Reported Event|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then Placebo
10874858|NCT00435188|BG000|Baseline|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic vis
10874859|NCT00435188|BG001|Baseline|Arm 2|Usual care
10874860|NCT00435188|BG002|Baseline|Total|Total of all reporting groups
10874861|NCT00435188|FG000|Participant Flow|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
10874862|NCT00435188|FG001|Participant Flow|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
10874863|NCT00435188|OG000|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
10874864|NCT00435188|OG001|Outcome|Arm 2|Usual care
10874865|NCT00435188|OG000|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
10874866|NCT00435188|OG001|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
10874867|NCT00435188|EG000|Reported Event|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
10874868|NCT00435188|EG001|Reported Event|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
10874869|NCT00435370|BG000|Baseline|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
10874870|NCT00435370|BG001|Baseline|Placebo|Placebo + risperidone (6mg/day)
10874871|NCT00435370|BG002|Baseline|Total|Total of all reporting groups
10874872|NCT00435370|FG000|Participant Flow|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
10874873|NCT00435370|FG001|Participant Flow|Placebo|Placebo + risperidone (6mg/day)
10874874|NCT00435370|OG000|Outcome|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
10874875|NCT00435370|OG001|Outcome|Placebo|Placebo + risperidone (6mg/day)
10874876|NCT00435370|EG000|Reported Event|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
10874877|NCT00435370|EG001|Reported Event|Placebo|Placebo + risperidone (6mg/day)
10874878|NCT00435409|BG000|Baseline|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
10874879|NCT00435409|BG001|Baseline|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
10874880|NCT00435409|BG002|Baseline|Total|Total of all reporting groups
10879360|NCT00457301|FG001|Participant Flow|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
10846321|NCT00274846|BG000|Baseline|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
10846322|NCT00274846|FG000|Participant Flow|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
10846323|NCT00274846|OG000|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
10846324|NCT00274846|OG000|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
10846325|NCT00274846|EG000|Reported Event|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
10846326|NCT00274924|BG000|Baseline|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
10846327|NCT00274924|BG001|Baseline|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
10846328|NCT00274924|BG002|Baseline|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
10846329|NCT00274924|BG003|Baseline|Total|Total of all reporting groups
10846330|NCT00274924|FG000|Participant Flow|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
10846331|NCT00274924|FG001|Participant Flow|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
10846332|NCT00274924|FG002|Participant Flow|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
10846333|NCT00274924|OG000|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
10846334|NCT00274924|OG001|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
10846335|NCT00274924|EG000|Reported Event|Step 1 - All Treated Patients|All treated patients regardless of eligibility.
10846336|NCT00274924|EG001|Reported Event|Step 2 - Mid-treatment PET Positive|Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.
10846337|NCT00274924|EG002|Reported Event|Step 2 - Mid-treatment PET Negative|Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
10846338|NCT00274937|BG000|Baseline|Stratum II|AJCC Stage IIb - IV
10846339|NCT00274937|FG000|Participant Flow|Stratum II|AJCC Stage IIb - IV
10846340|NCT00274937|OG000|Outcome|Stratum II|AJCC Stage IIb - IV
10846341|NCT00274937|EG000|Reported Event|Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)|"Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.~amifostine trihydrate: Given subcutaneously~fluorouracil: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies~radiation therapy: Undergo radiotherapy"
10846342|NCT00275002|BG000|Baseline|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
10846343|NCT00275002|BG001|Baseline|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
10983764|NCT00975481|OG001|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam tablets, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
10983765|NCT00975481|OG001|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
10983766|NCT00975481|EG000|Reported Event|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
10983767|NCT00975481|EG001|Reported Event|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
10983768|NCT00975481|EG002|Reported Event|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
10983769|NCT00975481|EG003|Reported Event|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
10983770|NCT00975481|EG004|Reported Event|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
10983771|NCT00975481|EG005|Reported Event|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
10983772|NCT00975507|BG000|Baseline|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
10983773|NCT00975507|BG001|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
10983774|NCT00975507|BG002|Baseline|Total|Total of all reporting groups
10983775|NCT00975507|FG000|Participant Flow|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
10983776|NCT00975507|FG001|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
11348160|NCT04207840|FG001|Participant Flow|B-C-A|Subjects received one of the three treatments during each study visit. Visit 1: Treatment B: Intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL), for a total dosage of 0.30 mg; Visit 2: Treatment C: Two (2) inhalations of Albuterol HFA (0.09 mg of albuterol sulfate per inhalation), for a total dosage of 0.18 mg; Visit 3: Treatment A: Two (2) inhalations of Primatene Mist (0.125 mg of epinephrine per inhalation), for a total dosage of 0.25 mg.
10983777|NCT00975507|OG000|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
10983778|NCT00975507|OG001|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
10983779|NCT00975507|OG002|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
10983780|NCT00975507|EG000|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0.
10983781|NCT00975507|EG001|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
10983782|NCT00975507|EG002|Reported Event|M-M-R™ II + VARIVAX™ (1 Injection)|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
10983783|NCT00975585|BG000|Baseline|Senofilcon A|contact lens
10983784|NCT00975585|BG001|Baseline|Lotrafilcon B|contact lens
10983785|NCT00975585|BG002|Baseline|Total|Total of all reporting groups
10983786|NCT00975585|FG000|Participant Flow|Senofilcon A|contact lens
10983787|NCT00975585|FG001|Participant Flow|Lotrafilcon B|contact lens
10983788|NCT00975585|OG000|Outcome|Senofilcon A|contact lens
10983789|NCT00975585|OG001|Outcome|Lotrafilcon B|contact lens
10983790|NCT00975585|OG000|Outcome|Lotrafilcon B at 2 Weeks|lotrafilcon B contact lens after two weeks of wear
10983791|NCT00975585|OG001|Outcome|Lotrafilcon B at 4 Weeks|lotrafilcon B contact lens after four weeks of wear
10846344|NCT00275002|BG002|Baseline|Total|Total of all reporting groups
10983792|NCT00975585|EG000|Reported Event|Senofilcon A|contact lens
10983793|NCT00975585|EG001|Reported Event|Lotrafilcon B|contact lens
10983794|NCT00975637|BG000|Baseline|Broda 210 mg|AMG 827: 210 mg SC
10983795|NCT00975637|BG001|Baseline|Broda 140 mg|AMG 827: 140 mg SC
10983796|NCT00975637|BG002|Baseline|Broda 280 mg|AMG 827: 280 mg SC
10983797|NCT00975637|BG003|Baseline|Placebo|Placebo: Placebo SC
10983798|NCT00975637|BG004|Baseline|Broda 70 mg|AMG 827: 70 mg SC
10983799|NCT00975637|BG005|Baseline|Total|Total of all reporting groups
10983800|NCT00975637|FG000|Participant Flow|210 mg|AMG 827: 210 mg SC
10983801|NCT00975637|FG001|Participant Flow|140 mg|AMG 827: 140 mg SC
10983802|NCT00975637|FG002|Participant Flow|280 mg|AMG 827: 280 mg SC
10983803|NCT00975637|FG003|Participant Flow|Placebo|Placebo: Placebo SC
10983804|NCT00975637|FG004|Participant Flow|70 mg|AMG 827: 70 mg SC
10983805|NCT00975637|OG000|Outcome|Broda 210 mg|AMG 827: 210 mg SC
10983806|NCT00975637|OG001|Outcome|Broda 140 mg|AMG 827: 140 mg SC
10983807|NCT00975637|OG002|Outcome|Broda 280 mg|AMG 827: 280 mg SC
10983808|NCT00975637|OG003|Outcome|Placebo|Placebo: Placebo SC
10983809|NCT00975637|OG004|Outcome|Broda 70 mg|AMG 827: 70 mg SC
10983810|NCT00975637|EG000|Reported Event|Broda 210 mg|AMG 827: 210 mg SC
10983811|NCT00975637|EG001|Reported Event|Broda 140 mg|AMG 827: 140 mg SC
10983812|NCT00975637|EG002|Reported Event|Broda 280 mg|AMG 827: 280 mg SC
10983813|NCT00975637|EG003|Reported Event|Placebo|Placebo: Placebo SC
10983814|NCT00975637|EG004|Reported Event|Broda 70 mg|AMG 827: 70 mg SC
10983815|NCT00975650|BG000|Baseline|All Subjects|All Subjects who were dosed.
10983816|NCT00975650|FG000|Participant Flow|Sequence 1|Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days;
10983817|NCT00975650|FG001|Participant Flow|Sequence 2|Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
10983818|NCT00975650|FG002|Participant Flow|Sequence 3|Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
10983819|NCT00975650|FG003|Participant Flow|Sequence 4|Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
10983820|NCT00975650|OG000|Outcome|Treatment A|Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
10983821|NCT00975650|OG001|Outcome|Treatment B|Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
10983822|NCT00975650|OG002|Outcome|Treatment C|Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
10983823|NCT00975650|OG003|Outcome|Treatment D|Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
10983824|NCT00975650|EG000|Reported Event|Treatment A|Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
10983825|NCT00975650|EG001|Reported Event|Treatment B|Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
10983826|NCT00975650|EG002|Reported Event|Treatment C|Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
10983827|NCT00975650|EG003|Reported Event|Treatment D|Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
10983828|NCT00975676|BG000|Baseline|Triptorelin Plus Tamoxifen|"Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.~gas chromatography / tandem mass spectometry: Determination of estrogen levels through gas chromatography."
10983829|NCT00975676|BG001|Baseline|Triptorelin Plus Exemestane|"Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.~gas chromatography / tandem mass spectometry: Determination of estrogen levels through gas chromatography."
10983830|NCT00975676|BG002|Baseline|Total|Total of all reporting groups
10983831|NCT00975676|FG000|Participant Flow|Triptorelin Plus Tamoxifen|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years. The final analytic cohort included 109 patients from the intent to treat (ITT) population, who had ≥2 samples assayed or E+Trip=83, T+Trip=26 respectively, patients with only baseline data were excluded.
10983832|NCT00975676|FG001|Participant Flow|Triptorelin Plus Exemestane|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years. The final analytic cohort included 109 patients from the intent to treat (ITT) population, who had ≥2 samples assayed or E+Trip=83, T+Trip=26 respectively, patients with only baseline data were excluded.
10983833|NCT00975676|OG000|Outcome|Triptorelin Plus Tamoxifen|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.
10983834|NCT00975676|OG001|Outcome|Triptorelin Plus Exemestane|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
10983835|NCT00975676|OG000|Outcome|Triptorelin Plus Exemestane|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
10983836|NCT00975676|OG000|Outcome|Triptorelin Plus Exemestane With Suboptimal Estrogen Suppression (E2>2.72 pg/mL)|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
10983837|NCT00975676|OG001|Outcome|Triptorelin Plus Exemestane Without Suboptimal Estrogen Suppression (E2>2.72 pg/mL)|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
10983838|NCT00975676|OG000|Outcome|Triptorelin Plus Exemestane With Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
10983839|NCT00975676|OG001|Outcome|Triptorelin Plus Exemestane Without Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
10983840|NCT00975676|EG000|Reported Event|Triptorelin Plus Tamoxifen|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.
10983841|NCT00975676|EG001|Reported Event|Triptorelin Plus Exemestane|Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
10983842|NCT00975689|BG000|Baseline|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
10983843|NCT00975689|BG001|Baseline|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
10983844|NCT00975689|BG002|Baseline|Total|Total of all reporting groups
10983845|NCT00975689|FG000|Participant Flow|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
11348161|NCT04207840|FG002|Participant Flow|C-A-B|Subjects received one of the three treatments during each study visit. Visit 1: Treatment C: Two (2) inhalations of Albuterol HFA (0.09 mg of albuterol sulfate per inhalation), for a total dosage of 0.18 mg; Visit 2: Treatment A: Two (2) inhalations of Primatene Mist (0.125 mg of epinephrine per inhalation), for a total dosage of 0.25 mg; Visit 3: Treatment B: Intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL), for a total dosage of 0.30 mg.
10879361|NCT00457301|OG000|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
10879362|NCT00457301|OG001|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
10879363|NCT00457301|EG000|Reported Event|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
10879364|NCT00457301|EG001|Reported Event|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
10879365|NCT00457366|BG000|Baseline|Quetiapine|"Quetiapine~Quetiapine: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QD"
10879366|NCT00457366|BG001|Baseline|Cocktail|"Cocktail (Haloperidol, Lorazepam, Cogentin)~Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary"
10879367|NCT00457366|BG002|Baseline|Total|Total of all reporting groups
10879368|NCT00457366|FG000|Participant Flow|Quetiapine|"Quetiapine is being compared to a cocktail consisting of haloperidol, lorazepam, and cogentin to see which works best in agitated patients that are being brought into the ER."
10879369|NCT00457366|FG001|Participant Flow|"Cocktail Consisting of Haloperidol, Lorazepam, Cogentin"|"This cocktail consisting of haloperidol, lorazepam, and cogentin is being compared to quetiapiene to see which works best in agitated patients that are being brought into the ER."
10879370|NCT00457366|OG000|Outcome|Cocktail|Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary.
10879371|NCT00457366|OG001|Outcome|Quetiapine|Quetiapine 300 mg PO
10879372|NCT00457366|EG000|Reported Event|Quetiapine|"Quetiapine~Quetiapine: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QD"
10879373|NCT00457366|EG001|Reported Event|Cocktail|"Cocktail (Haloperidol, Lorazepam, Cogentin)~Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary"
10879374|NCT00457392|BG000|Baseline|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
10879375|NCT00457392|BG001|Baseline|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
10879376|NCT00457392|BG002|Baseline|Total|Total of all reporting groups
10879377|NCT00457392|FG000|Participant Flow|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
10879378|NCT00457392|FG001|Participant Flow|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
10879379|NCT00457392|OG000|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
10879380|NCT00457392|OG001|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
10879381|NCT00457392|EG000|Reported Event|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
10879382|NCT00457392|EG001|Reported Event|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
10879383|NCT00457418|BG000|Baseline|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
10879384|NCT00457418|FG000|Participant Flow|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
10879385|NCT00457418|OG000|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
10879386|NCT00457418|EG000|Reported Event|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
10879387|NCT00457626|BG000|Baseline|Valsartan Open Label|Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
10879388|NCT00457626|FG000|Participant Flow|Valsartan Open Label|Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
10879389|NCT00457626|OG000|Outcome|Valsartan Open Label|Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
10879390|NCT00457626|EG000|Reported Event|Valsartan Open Label|Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
10879391|NCT00457639|BG000|Baseline|Characteristics of All Patients Enrolled|Participants who were randomized to receive either Cholic acid or Placebo
10983846|NCT00975689|FG001|Participant Flow|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
10983847|NCT00975689|OG000|Outcome|NAC Phase|
10983848|NCT00975689|OG001|Outcome|Placebo Phase|
10983849|NCT00975689|EG000|Reported Event|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
10983850|NCT00975689|EG001|Reported Event|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
10983851|NCT00975715|BG000|Baseline|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
10983852|NCT00975715|BG001|Baseline|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
10983853|NCT00975715|BG002|Baseline|Total|Total of all reporting groups
10983854|NCT00975715|FG000|Participant Flow|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
10983855|NCT00975715|FG001|Participant Flow|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
10983856|NCT00975715|OG000|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
10983857|NCT00975715|OG001|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
10983858|NCT00975715|EG000|Reported Event|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
10983859|NCT00975715|EG001|Reported Event|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
10983860|NCT00975780|BG000|Baseline|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
10983861|NCT00975780|BG001|Baseline|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
10846345|NCT00275002|FG000|Participant Flow|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
10983862|NCT00975780|BG002|Baseline|Total|Total of all reporting groups
10983863|NCT00975780|FG000|Participant Flow|Usual Care|"The usual oral care provided at the nursing home~Usual oral care : Usual oral care and feeding positioning"
10983864|NCT00975780|FG001|Participant Flow|Enhanced Oral Care|Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning
10983865|NCT00975780|OG000|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
10983866|NCT00975780|OG001|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
10983867|NCT00975780|EG000|Reported Event|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
10983868|NCT00975780|EG001|Reported Event|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
10983869|NCT00975806|BG000|Baseline|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg PO QD on Days 1 to 21 of each 21-day cycle
10983870|NCT00975806|BG001|Baseline|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
10983871|NCT00975806|BG002|Baseline|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
10983872|NCT00975806|BG003|Baseline|Total|Total of all reporting groups
10983873|NCT00975806|FG000|Participant Flow|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
10983874|NCT00975806|FG001|Participant Flow|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
10983875|NCT00975806|FG002|Participant Flow|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
10983876|NCT00975806|OG000|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
10983877|NCT00975806|OG000|Outcome|Phase 2: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
10983878|NCT00975806|OG000|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
10983879|NCT00975806|OG001|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
10983880|NCT00975806|OG002|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
10983881|NCT00975806|EG000|Reported Event|Cohort A|Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle
10983882|NCT00975806|EG001|Reported Event|Cohort F|Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
10983883|NCT00975806|EG002|Reported Event|Cohort G|Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
10983884|NCT00975884|BG000|Baseline|GSK2340272A (D21) GROUP|Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 (D21).
10874881|NCT00435409|FG000|Participant Flow|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 milligrams (mg) once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 milligrams per square meter (mg/m^2) per day (1000 mg/m^2 twice daily [BID]) from Days 1-14 every 3 weeks.
10874882|NCT00435409|FG001|Participant Flow|Capecitabine, no Crossover|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks.
10874883|NCT00435409|FG002|Participant Flow|Capecitabine, Crossover to Sunitinib|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
10874884|NCT00435409|OG000|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
10874885|NCT00435409|OG001|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
10874886|NCT00435409|EG000|Reported Event|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
10874887|NCT00435409|EG001|Reported Event|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
10874888|NCT00435461|BG000|Baseline|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
10874889|NCT00435461|BG001|Baseline|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
10874890|NCT00435461|BG002|Baseline|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
10874891|NCT00435461|BG003|Baseline|Total|Total of all reporting groups
10874892|NCT00435461|FG000|Participant Flow|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
10874893|NCT00435461|FG001|Participant Flow|FFNS 110 Microgram (mcg)|Participants received fluticasone furoate nasal spray (FFNS) 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
10874894|NCT00435461|FG002|Participant Flow|Fex 180 Milligram (mg)|Participants received oral capsule (overencapsulated fexofenadine [Fex] 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
10874895|NCT00435461|OG000|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
10874896|NCT00435461|OG001|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
10874897|NCT00435461|OG002|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
10874898|NCT00435461|EG000|Reported Event|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
10874899|NCT00435461|EG001|Reported Event|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
10874900|NCT00435461|EG002|Reported Event|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
10874901|NCT00435487|BG000|Baseline|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
10874902|NCT00435487|BG001|Baseline|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
10874903|NCT00435487|BG002|Baseline|Total|Total of all reporting groups
10874904|NCT00435487|FG000|Participant Flow|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
10874905|NCT00435487|FG001|Participant Flow|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
10874906|NCT00435487|OG000|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
10874907|NCT00435487|OG001|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
10983885|NCT00975884|BG001|Baseline|GSK2340272A (M6) GROUP|Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983886|NCT00975884|BG002|Baseline|Total|Total of all reporting groups
10983887|NCT00975884|FG000|Participant Flow|GSK2340272A (D21) GROUP|Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 (D21).
10983888|NCT00975884|FG001|Participant Flow|GSK2340272A (M6) GROUP|Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983889|NCT00975884|OG000|Outcome|GSK2340272A 18-60 YEARS SUB-GROUP|Pooled group for healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 and at Month 6.
10983890|NCT00975884|OG001|Outcome|GSK2340272A > 60 YEARS SUB-GROUP|Pooled group for healthy male or female adults, older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 and at Month 6.
10983891|NCT00975884|OG000|Outcome|GSK2340272A 18-60 Years (D21) GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 (D21).
10983892|NCT00975884|OG001|Outcome|GSK2340272A > 60 Years (D21) GROUP|Healthy male or female adults, older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10983893|NCT00975884|OG002|Outcome|GSK2340272A 18-60 Years (M6) GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983894|NCT00975884|OG003|Outcome|GSK2340272A > 60 Years (M6) GROUP|Healthy male or female adults, > 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983895|NCT00975884|OG000|Outcome|GSK2340272A 18-60 Years (M6) GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983896|NCT00975884|OG001|Outcome|GSK2340272A > 60 Years (M6) GROUP|GROUP Healthy male or female adults, > 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983897|NCT00975884|OG001|Outcome|GSK2340272A > 60 Years (M6) GROUP|Healthy male or female adults, > 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983898|NCT00975884|OG003|Outcome|GSK2340272A > 60 Years (M6) GROUP|GROUP Healthy male or female adults, > 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983899|NCT00975884|OG000|Outcome|GSK2340272A 18-60 YEARS (D21) GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 (D21).
10983900|NCT00975884|OG001|Outcome|GSK2340272A > 60 YEARS (D21) GROUP|Healthy male or female adults, older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10983901|NCT00975884|EG000|Reported Event|GSK2340272A (D21) GROUP|Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 (D21).
10983902|NCT00975884|EG001|Reported Event|GSK2340272A (M6) GROUP|Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6).
10983903|NCT00975923|BG000|Baseline|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
10983904|NCT00975923|BG001|Baseline|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
10983905|NCT00975923|BG002|Baseline|Total|Total of all reporting groups
10983906|NCT00975923|FG000|Participant Flow|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
10983907|NCT00975923|FG001|Participant Flow|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
10983908|NCT00975923|OG000|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
10983909|NCT00975923|OG001|Outcome|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for conducting quality improvement
10983910|NCT00975923|OG001|Outcome|Tool Kit Group|Hospitals allocated randomly to only a Tool Kit of clinical guidelines and aides for quality improvement
10983911|NCT00975923|EG000|Reported Event|Collaborative Group|Hospitals allocated randomly to the Collaborative Quality Improvement intervention with teleconferences and Tool Kit
10983912|NCT00975923|EG001|Reported Event|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for quality improvement
10983913|NCT00975975|BG000|Baseline|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
10983914|NCT00975975|FG000|Participant Flow|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
10983915|NCT00975975|OG000|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
10983916|NCT00975975|EG000|Reported Event|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
10983917|NCT00976027|BG000|Baseline|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
10983918|NCT00976027|BG001|Baseline|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
10983919|NCT00976027|BG002|Baseline|Total|Total of all reporting groups
10983920|NCT00976027|FG000|Participant Flow|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
10983921|NCT00976027|FG001|Participant Flow|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
10983922|NCT00976027|OG000|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
10983923|NCT00976027|OG001|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
10983924|NCT00976027|EG000|Reported Event|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
10983925|NCT00976027|EG001|Reported Event|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
10983926|NCT00976183|BG000|Baseline|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
11007162|NCT01089569|OG002|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
10879392|NCT00457639|FG000|Participant Flow|Cholic Acid Then Placebo|Cholic Acid for 6 months and then Placebo for six months in a double-blind, randomized fashion
10879393|NCT00457639|FG001|Participant Flow|Placebo Then Cholic Acid|Placebo for 6 months and then Cholic Acid for 6 months in a double-blind, randomized fashion
10879394|NCT00457639|OG000|Outcome|Cholic Acid|Cholic Acid 6 months .
10879395|NCT00457639|OG001|Outcome|Placebo|Placebo for 6 months.
10879396|NCT00457639|EG000|Reported Event|Cholic Acid|Cholic Acid for 6 months
10879397|NCT00457639|EG001|Reported Event|Placebo|Placebo for 6 months
10879398|NCT00457665|BG000|Baseline|Nelfinavir|Randomized to receive Nelfinavir inclusive HAART
10879399|NCT00457665|BG001|Baseline|Efavirenz|Randomized to receive Efavirenz inclusive HAART
10879400|NCT00457665|BG002|Baseline|Total|Total of all reporting groups
10879401|NCT00457665|FG000|Participant Flow|Nelfinavir|Randomized to receive Nelfinavir inclusive HAART
10879402|NCT00457665|FG001|Participant Flow|Efavirenz|Randomized to receive Efavirenz inclusive HAART
10879403|NCT00457665|OG000|Outcome|Nelfinavir (Viracept)|Assigned to Nelfinavir
10879404|NCT00457665|OG001|Outcome|Efavirenz (Sustiva)|Assigned to Efavirenz
10879405|NCT00457665|EG000|Reported Event|Nelfinavir|These participants were randomized to receive Nelfinavir
10879406|NCT00457665|EG001|Reported Event|Efavirenz|These participants were randomized to receive Efavirenz
10879407|NCT00457691|BG000|Baseline|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
10879408|NCT00457691|BG001|Baseline|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
10879409|NCT00457691|BG002|Baseline|Total|Total of all reporting groups
10879410|NCT00457691|FG000|Participant Flow|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
10879411|NCT00457691|FG001|Participant Flow|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
10879412|NCT00457691|OG000|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
10879413|NCT00457691|OG001|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
10983927|NCT00976183|FG000|Participant Flow|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
10983928|NCT00976183|OG000|Outcome|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
10983929|NCT00976183|EG000|Reported Event|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
10983930|NCT00976209|BG000|Baseline|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
10983931|NCT00976209|BG001|Baseline|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
10983932|NCT00976209|BG002|Baseline|Total|Total of all reporting groups
10983933|NCT00976209|FG000|Participant Flow|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
10983934|NCT00976209|FG001|Participant Flow|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
10983935|NCT00976209|OG000|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
10983936|NCT00976209|EG000|Reported Event|Phenylephrine HCl ER, 30 mg|Phenylephrine Hydrochloride (HCl) Extended Release (ER) tablets 30 mg taken every 12 hours, twice daily, for 3 days.
10983937|NCT00976209|EG001|Reported Event|Phenylephrine HCl IR, 10 mg|Phenylephrine Hydrochloride (HCl) Immediate Release tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
10983938|NCT00976248|BG000|Baseline|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
10983939|NCT00976248|FG000|Participant Flow|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
10983940|NCT00976248|OG000|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
10983941|NCT00976248|OG000|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001: Taken orally once a day"
10983942|NCT00976248|EG000|Reported Event|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
10983943|NCT00976274|BG000|Baseline|Starch Capsule|5 capsules three times everyday for 12 weeks
10983944|NCT00976274|BG001|Baseline|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
10983945|NCT00976274|BG002|Baseline|Total|Total of all reporting groups
10983946|NCT00976274|FG000|Participant Flow|Starch Capsule|5 capsules three times everyday for 12 weeks
10983947|NCT00976274|FG001|Participant Flow|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
10983948|NCT00976274|OG000|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
10983949|NCT00976274|OG001|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
10983950|NCT00976274|EG000|Reported Event|Starch Capsule|5 capsules three times everyday for 12 weeks
10983951|NCT00976274|EG001|Reported Event|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
10983952|NCT00976352|BG000|Baseline|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
11007163|NCT01089569|EG000|Reported Event|Exenatide|"5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study~Exenatide: refer to Arm detail"
11007164|NCT01089569|EG001|Reported Event|Insulin Glargine|".1 unit per kg to start, titrated based on Continuous Glucose Monitoring results~Insulin Glargine: refer to Arm detail"
10874908|NCT00435487|EG000|Reported Event|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
10874909|NCT00435487|EG001|Reported Event|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
10874910|NCT00435539|BG000|Baseline|Ocriplasmin 75µg Single Injection|ocriplasmin 75µg single injection versus sham injection
10874911|NCT00435539|BG001|Baseline|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
10874912|NCT00435539|BG002|Baseline|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
10874913|NCT00435539|BG003|Baseline|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
10874914|NCT00435539|BG004|Baseline|Sham Injection|sham injection
10874915|NCT00435539|BG005|Baseline|Total|Total of all reporting groups
10874916|NCT00435539|FG000|Participant Flow|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
10874917|NCT00435539|FG001|Participant Flow|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
10874918|NCT00435539|FG002|Participant Flow|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
10874919|NCT00435539|FG003|Participant Flow|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
10874920|NCT00435539|FG004|Participant Flow|Sham Injection|sham injection
10874921|NCT00435539|OG000|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
10874922|NCT00435539|OG001|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
10874923|NCT00435539|OG002|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
10874924|NCT00435539|OG003|Outcome|Sham Injection|sham injection
10874925|NCT00435539|EG000|Reported Event|Ocriplasmin 75µg|Ocriplasmin 75µg single injection versus sham injection
10874926|NCT00435539|EG001|Reported Event|Ocriplasmin 125µg Single Injection|Ocriplasmin 125µg single injection versus sham injection
10874927|NCT00435539|EG002|Reported Event|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
10874928|NCT00435539|EG003|Reported Event|Ocriplasmin 125µg Multiple Injection|Ocriplasmin 125µg multiple injection versus sham injection
10874929|NCT00435539|EG004|Reported Event|Sham Injection|Sham injection
10874930|NCT00435591|BG000|Baseline|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
10874931|NCT00435591|BG001|Baseline|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
10874932|NCT00435591|BG002|Baseline|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
10874933|NCT00435591|BG003|Baseline|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
10874934|NCT00435591|BG004|Baseline|Total|Total of all reporting groups
10874935|NCT00435591|FG000|Participant Flow|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
10874936|NCT00435591|FG001|Participant Flow|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
10874937|NCT00435591|FG002|Participant Flow|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
10874938|NCT00435591|FG003|Participant Flow|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
10874939|NCT00435591|OG000|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
10874940|NCT00435591|OG001|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
10874941|NCT00435591|OG002|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
10874942|NCT00435591|OG003|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
10874943|NCT00435591|OG000|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
10874944|NCT00435591|OG002|Outcome|Dose Regimen 3|Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
10874945|NCT00435591|OG003|Outcome|Dose Regimen 4|Conivaptan loading dose (20mg)+20mg/day continuous infusion conivaptan per premix bag
10874946|NCT00435591|EG000|Reported Event|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
10874947|NCT00435591|EG001|Reported Event|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
10874948|NCT00435591|EG002|Reported Event|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
10874949|NCT00435591|EG003|Reported Event|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
10874950|NCT00435812|BG000|Baseline|HEPLISAV and/or Placebo|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24
10874951|NCT00435812|BG001|Baseline|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
10874952|NCT00435812|BG002|Baseline|Total|Total of all reporting groups
10874953|NCT00435812|FG000|Participant Flow|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0 and Week 4, plus a placebo (saline) injection at Week 24"
10874954|NCT00435812|FG001|Participant Flow|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
10874955|NCT00435812|OG000|Outcome|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
10874956|NCT00435812|OG001|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
10874957|NCT00435812|EG000|Reported Event|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
10874958|NCT00435812|EG001|Reported Event|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
10874959|NCT00435825|BG000|Baseline|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
10874960|NCT00435825|BG001|Baseline|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
10874961|NCT00435825|BG002|Baseline|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
10874962|NCT00435825|BG003|Baseline|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
10874963|NCT00435825|BG004|Baseline|Total|Total of all reporting groups
10874964|NCT00435825|FG000|Participant Flow|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
10874965|NCT00435825|FG001|Participant Flow|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
10874966|NCT00435825|FG002|Participant Flow|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
10874967|NCT00435825|FG003|Participant Flow|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
10874968|NCT00435825|OG000|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
10874969|NCT00435825|OG001|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
10874970|NCT00435825|OG002|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
10874971|NCT00435825|OG003|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
10874972|NCT00435825|EG000|Reported Event|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
10874973|NCT00435825|EG001|Reported Event|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
10874974|NCT00435825|EG002|Reported Event|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
10874975|NCT00435825|EG003|Reported Event|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
10874976|NCT00435929|BG000|Baseline|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
10874977|NCT00435929|BG001|Baseline|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
10874978|NCT00435929|BG002|Baseline|Total|Total of all reporting groups
10874979|NCT00435929|FG000|Participant Flow|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
10874980|NCT00435929|FG001|Participant Flow|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
10874981|NCT00435929|OG000|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
10874982|NCT00435929|OG001|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
10874983|NCT00435929|EG000|Reported Event|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
10874984|NCT00435929|EG001|Reported Event|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
10874985|NCT00435942|BG000|Baseline|Relay Device Group|Endovascular Treatment arm
10874986|NCT00435942|BG001|Baseline|Surgical Control Group|Open Surgical Repair arm
10874987|NCT00435942|BG002|Baseline|Total|Total of all reporting groups
10874988|NCT00435942|FG000|Participant Flow|Relay Device Group|Endovascular Treatment arm
10874989|NCT00435942|FG001|Participant Flow|Surgical Control Group|Open Surgical Repair arm
10874990|NCT00435942|OG000|Outcome|Relay Device Group|Endovascular Treatment arm
10874991|NCT00435942|OG001|Outcome|Surgical Control Group|Open Surgical Repair arm
10874992|NCT00435942|EG000|Reported Event|Relay Device Group|Endovascular Treatment arm
10874993|NCT00435942|EG001|Reported Event|Surgical Control Group|Open Surgical Repair arm
10874994|NCT00435994|BG000|Baseline|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
10874995|NCT00435994|BG001|Baseline|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
10983953|NCT00976352|BG001|Baseline|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
10983954|NCT00976352|BG002|Baseline|Total|Total of all reporting groups
10983955|NCT00976352|FG000|Participant Flow|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
10983956|NCT00976352|FG001|Participant Flow|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
10983957|NCT00976352|OG000|Outcome|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
10983958|NCT00976352|OG001|Outcome|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
10983959|NCT00976352|OG000|Outcome|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270 after dosing."
10983960|NCT00976352|OG001|Outcome|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270 after dosing."
10983961|NCT00976352|OG000|Outcome|rAAV1-CMV-GAA Administration-cohort 1|RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270 after dosing.
10983962|NCT00976352|OG001|Outcome|rAAV1-CMV-GAA Administration-cohort 2|RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270 after dosing.
11007165|NCT01089569|EG002|Reported Event|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
11007166|NCT01089582|BG000|Baseline|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
11007167|NCT01089582|FG000|Participant Flow|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
10983963|NCT00976352|EG000|Reported Event|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
10983964|NCT00976352|EG001|Reported Event|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
10983965|NCT00976391|BG000|Baseline|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
10983966|NCT00976391|BG001|Baseline|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
10983967|NCT00976391|BG002|Baseline|Total|Total of all reporting groups
10983968|NCT00976391|FG000|Participant Flow|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
10983969|NCT00976391|FG001|Participant Flow|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
10983970|NCT00976391|OG000|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
10983971|NCT00976391|OG001|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
10983972|NCT00976391|EG000|Reported Event|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
10983973|NCT00976391|EG001|Reported Event|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
10983974|NCT00976404|BG000|Baseline|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
10983975|NCT00976404|BG001|Baseline|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
10983976|NCT00976404|BG002|Baseline|Total|Total of all reporting groups
10983977|NCT00976404|FG000|Participant Flow|ART Intensification: Maraviroc + Raltegravir|ART Intensification (addition of raltegravir and maraviroc) to suppressive ART for 56 weeks
10983978|NCT00976404|FG001|Participant Flow|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
10983979|NCT00976404|OG000|Outcome|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
10983980|NCT00976404|OG001|Outcome|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
10983981|NCT00976404|OG000|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
11007168|NCT01089582|OG000|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
11348162|NCT04207840|OG000|Outcome|Primatene Mist, E004|"Participants who dosed with Primatene Mist.~Epinephrine (0.125 mg/inhalation): Participants will self-administer 2 inhalations of Epinephrine (0.125 mg/inhalation) for a total dosage of 0.25 mg."
10983982|NCT00976404|OG001|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
10983983|NCT00976404|EG000|Reported Event|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
10983984|NCT00976404|EG001|Reported Event|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
10983985|NCT00976456|BG000|Baseline|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
10983986|NCT00976456|BG001|Baseline|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
10983987|NCT00976456|BG002|Baseline|Total|Total of all reporting groups
10983988|NCT00976456|FG000|Participant Flow|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
10983989|NCT00976456|FG001|Participant Flow|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
10983990|NCT00976456|OG000|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
10846346|NCT00275002|FG001|Participant Flow|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
10983991|NCT00976456|OG001|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
10983992|NCT00976456|EG000|Reported Event|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
10983993|NCT00976456|EG001|Reported Event|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
10983994|NCT00976482|BG000|Baseline|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
10983995|NCT00976482|FG000|Participant Flow|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
10983996|NCT00976482|OG000|Outcome|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
10983997|NCT00976482|EG000|Reported Event|Pacemaker|implanted Patients
10983998|NCT00976495|BG000|Baseline|Placebo|Tablet, oral, once daily for 12 weeks
10983999|NCT00976495|BG001|Baseline|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
10984000|NCT00976495|BG002|Baseline|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
10984001|NCT00976495|BG003|Baseline|Total|Total of all reporting groups
10984002|NCT00976495|FG000|Participant Flow|Placebo|Tablet, oral, once daily for 12 weeks
10984003|NCT00976495|FG001|Participant Flow|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
10984004|NCT00976495|FG002|Participant Flow|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
10984005|NCT00976495|OG000|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
10984006|NCT00976495|OG001|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
10984007|NCT00976495|OG002|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
10984008|NCT00976495|EG000|Reported Event|Placebo|Tablet, oral, once daily for 12 weeks
10984009|NCT00976495|EG001|Reported Event|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
10984010|NCT00976495|EG002|Reported Event|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
10984011|NCT00976508|BG000|Baseline|Figitumumab 20 mg/kg +Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
10984012|NCT00976508|BG001|Baseline|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
10984013|NCT00976508|BG002|Baseline|Total|Total of all reporting groups
10984014|NCT00976508|FG000|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
11007169|NCT01089582|EG000|Reported Event|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
11007170|NCT01089595|BG000|Baseline|Nilotinib|Nilotinib 400 mg po bid
11007171|NCT01089595|BG001|Baseline|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
10874996|NCT00435994|BG002|Baseline|Bronchiolitis|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
10874997|NCT00435994|BG003|Baseline|Total|Total of all reporting groups
10874998|NCT00435994|FG000|Participant Flow|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
10874999|NCT00435994|FG001|Participant Flow|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
10875000|NCT00435994|FG002|Participant Flow|Bronchiolitis-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
10875001|NCT00435994|OG000|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.
10875002|NCT00435994|OG001|Outcome|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
10875003|NCT00435994|OG000|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
10875004|NCT00435994|OG001|Outcome|Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis and respiratory syncytial virus received nasal wash only.
10875005|NCT00435994|EG000|Reported Event|Healthy Control|
10875006|NCT00435994|EG001|Reported Event|Respiratory Syncytial Virus|
10875007|NCT00435994|EG002|Reported Event|Bronchiolitis|
10875008|NCT00436007|BG000|Baseline|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
10875009|NCT00436007|BG001|Baseline|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875010|NCT00436007|BG002|Baseline|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875011|NCT00436007|BG003|Baseline|Total|Total of all reporting groups
10875012|NCT00436007|FG000|Participant Flow|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
10875013|NCT00436007|FG001|Participant Flow|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875014|NCT00436007|FG002|Participant Flow|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875015|NCT00436007|OG000|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
11007172|NCT01089595|BG002|Baseline|Total|Total of all reporting groups
11007173|NCT01089595|FG000|Participant Flow|Nilotinib|Nilotinib 400 mg po bid
11007174|NCT01089595|FG001|Participant Flow|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
10984015|NCT00976508|FG001|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
10984016|NCT00976508|OG000|Outcome|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
10984017|NCT00976508|OG001|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
10984018|NCT00976508|OG000|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
10984019|NCT00976508|OG001|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
10984020|NCT00976508|OG001|Outcome|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
10984021|NCT00976508|EG000|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
10984022|NCT00976508|EG001|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
10984023|NCT00976521|BG000|Baseline|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
10984024|NCT00976521|BG001|Baseline|Local Infusion, no Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration
10984025|NCT00976521|BG002|Baseline|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
10984026|NCT00976521|BG003|Baseline|No Local Infusion, no Aspiration|No local infusion of abciximab and no thrombus aspiration
10984027|NCT00976521|BG004|Baseline|Total|Total of all reporting groups
10984028|NCT00976521|FG000|Participant Flow|Local Infusion, Thrombus Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.~A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.~After withdrawing the aspiration catheter, the lesion is crossed with a 1.0 mm, 1.5 mm, or 2.0 mm diameter ClearWay™ RX Infusion Catheter (depending on the lumen diameter created by thrombus aspiration and the reference vessel diameter). If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
10984029|NCT00976521|FG001|Participant Flow|Local Infusion, no Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.~The initial device used to cross the lesion is a 1.0 mm or 1.5 mm diameter ClearWay™ RX Infusion Catheter (1.0 mm for complete occlusion).~If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
10984030|NCT00976521|FG002|Participant Flow|No Local Infusion, Thrombus Aspiration|"No local infusion of abciximab, thrombus aspiration.~A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed."
10984031|NCT00976521|FG003|Participant Flow|No Local Infusion, no Aspiration|"No local infusion of abciximab and no thrombus aspiration.~The lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care."
10984032|NCT00976521|OG000|Outcome|Abciximab Infusion|Abciximab Infusion includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or abciximab infusion arm without aspiration. If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
11007175|NCT01089595|OG000|Outcome|Nilotinib|Nilotinib 400 mg by mouth (PO), twice daily (BID)
11007176|NCT01089595|OG001|Outcome|Nilotinib + Imatinib|Nilotinib 400 mg twice daily (BID) with Imatinib 400 mg daily
10984033|NCT00976521|OG001|Outcome|No Infusion|No Infusion includes subjects randomized to either the following two arms: no abciximab infusion with aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion with aspiration, a 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until no further thrombus is being removed. If randomized to no abciximab infusion without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
10984034|NCT00976521|OG002|Outcome|Combined|Combined includes subjects randomized to all four arms.
10984035|NCT00976521|OG000|Outcome|Thrombus Aspiration|Thrombus aspiration includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or no abciximab infusion with aspiration. A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter. Multiple passes should be made with contrast injection after each pass until the operator appreciates that no further thrombus is being removed.
10984036|NCT00976521|OG001|Outcome|No Aspiration|No aspiration includes subjects randomized to either the following two arms: abciximab infusion arm without aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion without aspiration, the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter. If randomized to no abciximab without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
10984037|NCT00976521|EG000|Reported Event|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration
10984038|NCT00976521|EG001|Reported Event|Local Infusion, No Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.
10984039|NCT00976521|EG002|Reported Event|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
10984040|NCT00976521|EG003|Reported Event|No Local Infusion, No Aspiration|No local infusion of abciximab and no thrombus aspiration.
10984041|NCT00976560|BG000|Baseline|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
10984042|NCT00976560|BG001|Baseline|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
10984043|NCT00976560|BG002|Baseline|Total|Total of all reporting groups
10984044|NCT00976560|FG000|Participant Flow|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
10984045|NCT00976560|FG001|Participant Flow|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
10984046|NCT00976560|OG000|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
10984047|NCT00976560|OG001|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
10984048|NCT00976560|EG000|Reported Event|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
10984049|NCT00976560|EG001|Reported Event|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
10984050|NCT00976573|BG000|Baseline|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10984051|NCT00976573|BG001|Baseline|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10846347|NCT00275002|OG000|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
10984052|NCT00976573|BG002|Baseline|Total|Total of all reporting groups
10984053|NCT00976573|FG000|Participant Flow|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10984054|NCT00976573|FG001|Participant Flow|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10984055|NCT00976573|OG000|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10984056|NCT00976573|OG001|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11007177|NCT01089595|OG000|Outcome|Nilotinib|Nilotinib 400 mg po bid
10984057|NCT00976573|EG000|Reported Event|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10984058|NCT00976573|EG001|Reported Event|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10984059|NCT00976599|BG000|Baseline|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
10984060|NCT00976599|BG001|Baseline|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
10984061|NCT00976599|BG002|Baseline|Total|Total of all reporting groups
10984062|NCT00976599|FG000|Participant Flow|CP-690,550|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
10984063|NCT00976599|FG001|Participant Flow|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
10984064|NCT00976599|OG000|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
10984065|NCT00976599|OG001|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
10984066|NCT00976599|EG000|Reported Event|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
10984067|NCT00976599|EG001|Reported Event|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
10984068|NCT00976664|BG000|Baseline|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
10984069|NCT00976664|BG001|Baseline|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
10984070|NCT00976664|BG002|Baseline|Total|Total of all reporting groups
10984071|NCT00976664|FG000|Participant Flow|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
10984072|NCT00976664|FG001|Participant Flow|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
10984073|NCT00976664|OG000|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
10984074|NCT00976664|OG001|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
10984075|NCT00976664|EG000|Reported Event|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
10984076|NCT00976664|EG001|Reported Event|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
10984077|NCT00976677|BG000|Baseline|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
10984078|NCT00976677|BG001|Baseline|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
10984079|NCT00976677|BG002|Baseline|Total|Total of all reporting groups
10984080|NCT00976677|FG000|Participant Flow|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
10984081|NCT00976677|FG001|Participant Flow|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
10984082|NCT00976677|OG000|Outcome|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
10984083|NCT00976677|OG001|Outcome|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
10984084|NCT00976677|EG000|Reported Event|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
10984085|NCT00976677|EG001|Reported Event|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
10984086|NCT00976703|BG000|Baseline|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
10984087|NCT00976703|BG001|Baseline|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
10984088|NCT00976703|BG002|Baseline|Total|Total of all reporting groups
10984089|NCT00976703|FG000|Participant Flow|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
10984090|NCT00976703|FG001|Participant Flow|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
10984091|NCT00976703|OG000|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
10984092|NCT00976703|OG001|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
10984093|NCT00976703|EG000|Reported Event|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
10984094|NCT00976703|EG001|Reported Event|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
10984095|NCT00976716|BG000|Baseline|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
10984096|NCT00976716|FG000|Participant Flow|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.
10984097|NCT00976716|OG000|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
10984098|NCT00976716|OG000|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
10984099|NCT00976716|EG000|Reported Event|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
10984100|NCT00976820|BG000|Baseline|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984101|NCT00976820|BG001|Baseline|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984102|NCT00976820|BG002|Baseline|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
11007178|NCT01089595|OG001|Outcome|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
11007179|NCT01089595|EG000|Reported Event|Nilotinib|Nilotinib 400 mg po bid
10984103|NCT00976820|BG003|Baseline|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984104|NCT00976820|BG004|Baseline|Total|Total of all reporting groups
10984105|NCT00976820|FG000|Participant Flow|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984106|NCT00976820|FG001|Participant Flow|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984107|NCT00976820|FG002|Participant Flow|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984108|NCT00976820|FG003|Participant Flow|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984109|NCT00976820|OG000|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984110|NCT00976820|OG001|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984111|NCT00976820|OG002|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984112|NCT00976820|OG003|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984113|NCT00976820|OG000|Outcome|Arepanrix/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984114|NCT00976820|OG001|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984115|NCT00976820|OG002|Outcome|Arepanrix/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10846348|NCT00275002|OG001|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
11007180|NCT01089595|EG001|Reported Event|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
11007181|NCT01089608|BG000|Baseline|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
10875016|NCT00436007|OG001|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875017|NCT00436007|OG002|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875018|NCT00436007|OG000|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875019|NCT00436007|OG000|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875020|NCT00436007|OG000|Outcome|GSK 257049 1 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875021|NCT00436007|OG002|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania
10875022|NCT00436007|OG001|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875023|NCT00436007|EG000|Reported Event|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
10875024|NCT00436007|EG001|Reported Event|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10879414|NCT00457691|EG000|Reported Event|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
10875025|NCT00436007|EG002|Reported Event|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
10875026|NCT00436046|BG000|Baseline|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
10875027|NCT00436046|BG001|Baseline|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
10875028|NCT00436046|BG002|Baseline|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
10875029|NCT00436046|BG003|Baseline|Total|Total of all reporting groups
10875030|NCT00436046|FG000|Participant Flow|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
10875031|NCT00436046|FG001|Participant Flow|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
10875032|NCT00436046|FG002|Participant Flow|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
10875033|NCT00436046|OG000|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
10875034|NCT00436046|OG001|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
10875035|NCT00436046|OG002|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
10875036|NCT00436046|EG000|Reported Event|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
10875037|NCT00436046|EG001|Reported Event|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
10875038|NCT00436046|EG002|Reported Event|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
10875039|NCT00436163|BG000|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
10875040|NCT00436163|FG000|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks.
10875041|NCT00436163|OG000|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
10875042|NCT00436163|OG000|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
10875043|NCT00436163|EG000|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
10875044|NCT00436215|BG000|Baseline|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
10875045|NCT00436215|FG000|Participant Flow|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
10875046|NCT00436215|OG000|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
10875047|NCT00436215|EG000|Reported Event|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
10875048|NCT00436280|BG000|Baseline|Enzastaurin + R-GEMOX|Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
10875049|NCT00436280|FG000|Participant Flow|Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)|Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease (PD)/Toxicity or up to 3 years.
10875050|NCT00436280|OG000|Outcome|Enzastaurin + R-GEMOX|Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, orally, daily with Gemcitabine: 1000 milligram per square meter (mg/m²) administered intravenously (IV); Rituximab: 375 mg/m² IV; Oxaliplatin: 100 mg/m² IV all given once every 2 weeks (1 Cycle) for 4 Cycles for Induction. If responding participants receive 4 additional Cycles for consolidation, Enzastaurin will be given as maintenance until Progressive Disease/Toxicity or up to 3 years.
10875051|NCT00436280|EG000|Reported Event|Enzastaurin + R-GEMOX|"enzastaurin: 1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years~gemcitabine: 1000 mg/m2, IV, once, every two weeks, four to eight 2 week cycles~rituximab: 375 mg/m2, IV, once every 2 weeks, four to eight 2 week cycles~oxaliplatin: 100 mg/m2, IV, once every two weeks, four to eight 2 week cycles"
10875052|NCT00436332|BG000|Baseline|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
10875053|NCT00436332|FG000|Participant Flow|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
10984116|NCT00976820|OG003|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984117|NCT00976820|OG004|Outcome|GSK2340273A/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984118|NCT00976820|OG005|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984119|NCT00976820|OG006|Outcome|GSK2340273A/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984120|NCT00976820|OG007|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984121|NCT00976820|OG002|Outcome|Arepanrix/F1 Out Group|Subjects, out of age interval, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984122|NCT00976820|OG003|Outcome|Arepanrix/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984123|NCT00976820|OG004|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984124|NCT00976820|OG005|Outcome|GSK2340273A/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984125|NCT00976820|OG006|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984126|NCT00976820|OG007|Outcome|GSK2340273A/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984127|NCT00976820|OG008|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10846349|NCT00275002|EG000|Reported Event|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
10875054|NCT00436332|OG000|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
10875055|NCT00436332|EG000|Reported Event|Erlotinib and Bevacizumab|Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
10875056|NCT00436345|BG000|Baseline|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
10875057|NCT00436345|BG001|Baseline|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
10875058|NCT00436345|BG002|Baseline|Total|Total of all reporting groups
10875059|NCT00436345|FG000|Participant Flow|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
10875060|NCT00436345|FG001|Participant Flow|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
10875061|NCT00436345|OG000|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
10875062|NCT00436345|OG001|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
10875063|NCT00436345|OG000|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per killograms per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
10875064|NCT00436345|EG000|Reported Event|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
10875065|NCT00436345|EG001|Reported Event|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
10875066|NCT00436436|BG000|Baseline|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
10875067|NCT00436436|FG000|Participant Flow|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
10875068|NCT00436436|OG000|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
10875069|NCT00436436|EG000|Reported Event|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
10875070|NCT00436475|BG000|Baseline|Vitamin D-Calcium|Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
10875071|NCT00436475|BG001|Baseline|Vitamin D Only|Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
10875072|NCT00436475|BG002|Baseline|Calcium Only|Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
10875073|NCT00436475|BG003|Baseline|Placebo-Placebo|Vitamin D3-Placebo plus Calcium-Placebo
10875074|NCT00436475|BG004|Baseline|Total|Total of all reporting groups
10875075|NCT00436475|FG000|Participant Flow|Vitamin D-Calcium|Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
10875076|NCT00436475|FG001|Participant Flow|Vitamin D Only|Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
10875077|NCT00436475|FG002|Participant Flow|Calcium Only|Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
10875078|NCT00436475|FG003|Participant Flow|Placebo-Placebo|Vitamin D3-Placebo plus Calcium-Placebo
10875079|NCT00436475|OG000|Outcome|Vitamin D-Calcium|Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
10875080|NCT00436475|OG001|Outcome|Vitamin D Only|Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
10875081|NCT00436475|OG002|Outcome|Calcium Only|Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
10875082|NCT00436475|OG003|Outcome|Placebo-Placebo|Vitamin D3-Placebo plus Calcium-Placebo
10875083|NCT00436475|EG000|Reported Event|Vitamin D-Calcium|Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
10875084|NCT00436475|EG001|Reported Event|Vitamin D Only|Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
11007182|NCT01089608|BG001|Baseline|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
10875085|NCT00436475|EG002|Reported Event|Calcium Only|Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
10875086|NCT00436475|EG003|Reported Event|Placebo-Placebo|Vitamin D3-Placebo plus Calcium-Placebo
10875087|NCT00436501|BG000|Baseline|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
10875088|NCT00436501|BG001|Baseline|Phase II VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
10875089|NCT00436501|BG002|Baseline|Total|Total of all reporting groups
10875090|NCT00436501|FG000|Participant Flow|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
10875091|NCT00436501|FG001|Participant Flow|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
10875092|NCT00436501|OG000|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
10875093|NCT00436501|OG001|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
10875094|NCT00436501|OG000|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
10875095|NCT00436501|EG000|Reported Event|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
10875096|NCT00436501|EG001|Reported Event|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
10875097|NCT00436553|BG000|Baseline|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
10875098|NCT00436553|BG001|Baseline|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
10875099|NCT00436553|BG002|Baseline|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
10875100|NCT00436553|BG003|Baseline|Total|Total of all reporting groups
10875101|NCT00436553|FG000|Participant Flow|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
10879415|NCT00457691|EG001|Reported Event|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
10984128|NCT00976820|OG000|Outcome|Arepanrix/F1 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984129|NCT00976820|OG001|Outcome|Arepanrix/F1 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984130|NCT00976820|OG002|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984131|NCT00976820|OG003|Outcome|Arepanrix/F1 Out Group|Subjects, out of age interval, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984132|NCT00976820|OG004|Outcome|Arepanrix/F2 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984133|NCT00976820|OG005|Outcome|Arepanrix/F2 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984134|NCT00976820|OG006|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984135|NCT00976820|OG007|Outcome|GSK2340273A/F1 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984136|NCT00976820|OG008|Outcome|GSK2340273A/F1 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984137|NCT00976820|OG009|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984138|NCT00976820|OG010|Outcome|GSK2340273A/F2 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984139|NCT00976820|OG011|Outcome|GSK2340273A/F2 3Y-6Y Group|Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984140|NCT00976820|OG012|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
11007183|NCT01089608|BG002|Baseline|Total|Total of all reporting groups
10984141|NCT00976820|OG001|Outcome|Arepanrix/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984142|NCT00976820|OG002|Outcome|GSK2340273A/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984143|NCT00976820|OG003|Outcome|GSK2340273A/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984144|NCT00976820|OG000|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984145|NCT00976820|OG001|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984146|NCT00976820|OG002|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984147|NCT00976820|OG003|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984148|NCT00976820|OG002|Outcome|Arepanrix/F2 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984149|NCT00976820|OG003|Outcome|Arepanrix/F2 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984150|NCT00976820|OG004|Outcome|GSK2340273A/F1 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984151|NCT00976820|OG005|Outcome|GSK2340273A/F1 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984152|NCT00976820|OG006|Outcome|GSK2340273A/F2 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984153|NCT00976820|OG007|Outcome|GSK2340273A/F2 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984154|NCT00976820|EG000|Reported Event|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984155|NCT00976820|EG001|Reported Event|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984156|NCT00976820|EG002|Reported Event|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984157|NCT00976820|EG003|Reported Event|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
10984158|NCT00976898|BG000|Baseline|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
10984159|NCT00976898|FG000|Participant Flow|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
10984160|NCT00976898|OG000|Outcome|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
10984161|NCT00976898|EG000|Reported Event|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
10984162|NCT00976937|BG000|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 mg capsule orally QD up to Week 24.
10984163|NCT00976937|BG001|Baseline|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10984164|NCT00976937|BG002|Baseline|Total|Total of all reporting groups
10984165|NCT00976937|FG000|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
10984166|NCT00976937|FG001|Participant Flow|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10984167|NCT00976937|OG000|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
10984168|NCT00976937|OG001|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
10984169|NCT00976937|EG000|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
10984170|NCT00976937|EG001|Reported Event|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
10984171|NCT00976950|BG000|Baseline|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
10984172|NCT00976950|FG000|Participant Flow|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
10984173|NCT00976950|OG000|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
10984174|NCT00976950|EG000|Reported Event|Aptivus and Ritonavir|ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
10984175|NCT00976989|BG000|Baseline|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
10984176|NCT00976989|BG001|Baseline|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
10984177|NCT00976989|BG002|Baseline|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
10984178|NCT00976989|BG003|Baseline|Total|Total of all reporting groups
10984179|NCT00976989|FG000|Participant Flow|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
10984180|NCT00976989|FG001|Participant Flow|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
10984181|NCT00976989|FG002|Participant Flow|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
10984182|NCT00976989|OG000|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
10984183|NCT00976989|OG001|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
10984184|NCT00976989|OG002|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
10984185|NCT00976989|EG000|Reported Event|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
10984186|NCT00976989|EG001|Reported Event|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
10984187|NCT00976989|EG002|Reported Event|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
10984188|NCT00977080|BG000|Baseline|IV Paricalcitol in the IV Stratum|IV stratum
10984189|NCT00977080|BG001|Baseline|Cinacalcet in the IV Stratum|IV stratum
10984190|NCT00977080|BG002|Baseline|Oral Paricalcitol in the Oral Stratum|Oral stratum
10984191|NCT00977080|BG003|Baseline|Cinacalcet in the Oral Stratum|Oral stratum
10984192|NCT00977080|BG004|Baseline|Total|Total of all reporting groups
10984193|NCT00977080|FG000|Participant Flow|IV Paricalcitol in the IV Stratum|IV stratum
10984194|NCT00977080|FG001|Participant Flow|Cinacalcet in the IV Stratum|IV stratum
10984195|NCT00977080|FG002|Participant Flow|Oral Paricalcitol in the Oral Stratum|Oral stratum
10984196|NCT00977080|FG003|Participant Flow|Cinacalcet in the Oral Stratum|Oral stratum
10984197|NCT00977080|OG000|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
10984198|NCT00977080|OG001|Outcome|Cinacalcet in the IV Stratum|IV stratum
10984199|NCT00977080|OG002|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
10984200|NCT00977080|OG003|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
10984201|NCT00977080|EG000|Reported Event|IV Paricalcitol in the IV Stratum|IV stratum
10984202|NCT00977080|EG001|Reported Event|Cinacalcet in the IV Stratum|IV stratum
10984203|NCT00977080|EG002|Reported Event|Oral Paricalcitol in the Oral Stratum|Oral stratum
10984204|NCT00977080|EG003|Reported Event|Cinacalcet in the Oral Stratum|Oral stratum
10984205|NCT00977106|BG000|Baseline|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
10984206|NCT00977106|BG001|Baseline|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
10984207|NCT00977106|BG002|Baseline|Total|Total of all reporting groups
10984208|NCT00977106|FG000|Participant Flow|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) intravenously (IV) during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 milligrams per kilogram (mg/kg; 800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
10984209|NCT00977106|FG001|Participant Flow|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
10984210|NCT00977106|OG000|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
10984211|NCT00977106|OG001|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
10984212|NCT00977106|OG000|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
10984213|NCT00977106|OG000|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
10984214|NCT00977106|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
10984215|NCT00977106|EG001|Reported Event|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
10984216|NCT00977171|BG000|Baseline|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
10984217|NCT00977171|FG000|Participant Flow|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
10984218|NCT00977171|OG000|Outcome|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
10984219|NCT00977171|EG000|Reported Event|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
10984220|NCT00977184|BG000|Baseline|Real rTMS|Subjects receiving real rTMS
10984221|NCT00977184|BG001|Baseline|Sham rTMS|Subjects receiving sham rTMS.
10984222|NCT00977184|BG002|Baseline|Total|Total of all reporting groups
10984223|NCT00977184|FG000|Participant Flow|Real rTMS|Subjects receiving real rTMS
10984224|NCT00977184|FG001|Participant Flow|Sham rTMS|Subjects receiving sham rTMS.
10984225|NCT00977184|OG000|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
10984226|NCT00977184|OG001|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
10984227|NCT00977184|OG002|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
10984228|NCT00977184|OG003|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
10984229|NCT00977184|OG001|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
10984230|NCT00977184|OG001|Outcome|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
10984231|NCT00977184|OG002|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
10984232|NCT00977184|EG000|Reported Event|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
10984233|NCT00977184|EG001|Reported Event|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
10984234|NCT00977184|EG002|Reported Event|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
10984235|NCT00977184|EG003|Reported Event|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
10984236|NCT00977197|BG000|Baseline|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
10984237|NCT00977197|BG001|Baseline|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
10984238|NCT00977197|BG002|Baseline|Total|Total of all reporting groups
10984239|NCT00977197|FG000|Participant Flow|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.~Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
10984240|NCT00977197|FG001|Participant Flow|Placebo|"Subjects randomized to this arm will receive placebo matching the study drug.~Placebo: A matching placebo will be administered twice a day"
10984241|NCT00977197|OG000|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
10984242|NCT00977197|OG001|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
10984243|NCT00977197|EG000|Reported Event|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
10984244|NCT00977197|EG001|Reported Event|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
10984245|NCT00977314|BG000|Baseline|Analyzed Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
10984246|NCT00977314|BG001|Baseline|Pilot Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
10984247|NCT00977314|BG002|Baseline|Total|Total of all reporting groups
10984248|NCT00977314|FG000|Participant Flow|Analyzed Group|30 subjects were enrolled in the analyzed group with only 24 subjects expected to complete it. With an approximated 20% subject dropout rate anticipated. The total number of subjects that completed the study was 28 of 30 enrolled in the analyzed group.
10984249|NCT00977314|FG001|Participant Flow|Pilot Group|"Per the protocol, the first five (5) subjects were enrolled in the pilot group of the study to work out the process flow and training of the centers and participants."
10984250|NCT00977314|OG000|Outcome|Medical, Dental, Audiological Safety 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:~Comprehensive Medical evaluation at Enrollment and at Termination~Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed~Comprehensive Audiological evaluation at Enrollment and Termination.~No Medical, Dental or Audiological adverse events."
10984251|NCT00977314|OG000|Outcome|HINT (dB) Advantage|"Effectiveness was defined as Change from Baseline analysis of the Hearing in Noise Test (HINT), Noise on Better Side Scores between without the BCD at day one and with the BCD at day thirty.Effectiveness was determined as an improvement in the HINT score for which the device was designed, that is, the condition where noise originates on the normal hearing side and speech is presented from the front. .~An improvement in HINT score is indicated as a negative (-) dB value change. A change in the HINT score of -1 dB represents an improvement of 10% in speech intelligibility in that particular test condition. A 10% improvement in speech intelligibility in this very adverse listening condition is a noticeable benefit to the SSD subject. This amount of improvement is even more of a benefit in more realistic, less adverse listening conditions."
10984252|NCT00977314|OG000|Outcome|Global Benefit|The Global Benefit APHAB at 30 days is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 30 days of therapy. The APHAB questionnaire produces an overall Global score (GBL). The benefit provided by the SoundBite System can be determined by comparing changes in the mean APHAB score. The larger the APHAB benefit score the great the benefit. A negative APHAB score represents therapy resulting in a worse outcome than no therapy.
10984253|NCT00977314|EG000|Reported Event|Incidence of Device- and Procedure-related Adverse Events|Incidence of device- and procedure-related adverse events at 30 days
10984254|NCT00977379|BG000|Baseline|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
10984255|NCT00977379|BG001|Baseline|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
10984256|NCT00977379|BG002|Baseline|Total|Total of all reporting groups
10984257|NCT00977379|FG000|Participant Flow|WBRT Followed by Standard of Care|Participants received 3000 centi-Gray (cGy) whole brain radiation therapy (WBRT) in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (central nervous system [CNS] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
10984258|NCT00977379|FG001|Participant Flow|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
10984259|NCT00977379|OG000|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
10984260|NCT00977379|OG001|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
10984261|NCT00977379|EG000|Reported Event|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
10984262|NCT00977379|EG001|Reported Event|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
10875102|NCT00436553|FG001|Participant Flow|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
10875103|NCT00436553|FG002|Participant Flow|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
10875104|NCT00436553|OG000|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
10875105|NCT00436553|OG001|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
10875106|NCT00436553|OG002|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
10875107|NCT00436553|EG000|Reported Event|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
10875108|NCT00436553|EG001|Reported Event|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
10875109|NCT00436553|EG002|Reported Event|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
10984263|NCT00977431|BG000|Baseline|Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984264|NCT00977431|BG001|Baseline|Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984265|NCT00977431|BG002|Baseline|Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984266|NCT00977431|BG003|Baseline|Afatinib 20 mg, Radiotherapy - Regimen U|Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984267|NCT00977431|BG004|Baseline|Afatinib 40 mg, Radiotherapy - Regimen U|Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984268|NCT00977431|BG005|Baseline|Total|Total of all reporting groups
10984269|NCT00977431|FG000|Participant Flow|Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984270|NCT00977431|FG001|Participant Flow|Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984271|NCT00977431|FG002|Participant Flow|Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984272|NCT00977431|FG003|Participant Flow|Afatinib 20 mg, Radiotherapy - Regimen U|Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
11007184|NCT01089608|FG000|Participant Flow|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
10875110|NCT00436566|BG000|Baseline|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
10875111|NCT00436566|FG000|Participant Flow|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
10875112|NCT00436566|OG000|Outcome|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
10875113|NCT00436566|EG000|Reported Event|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
10875114|NCT00436605|BG000|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
10875115|NCT00436605|FG000|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10875116|NCT00436605|OG000|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10875117|NCT00436605|EG000|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10875118|NCT00436618|BG000|Baseline|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875119|NCT00436618|BG001|Baseline|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875120|NCT00436618|BG002|Baseline|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875121|NCT00436618|BG003|Baseline|Total|Total of all reporting groups
10875122|NCT00436618|FG000|Participant Flow|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875123|NCT00436618|FG001|Participant Flow|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875124|NCT00436618|FG002|Participant Flow|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875125|NCT00436618|OG000|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875126|NCT00436618|OG001|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875127|NCT00436618|OG002|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875128|NCT00436618|EG000|Reported Event|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875129|NCT00436618|EG001|Reported Event|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10875130|NCT00436618|EG002|Reported Event|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
10984273|NCT00977431|FG004|Participant Flow|Afatinib 40 mg, Radiotherapy - Regimen U|Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984274|NCT00977431|OG000|Outcome|Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984275|NCT00977431|OG001|Outcome|Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984276|NCT00977431|OG002|Outcome|Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984277|NCT00977431|OG003|Outcome|Afatinib 20 mg, Radiotherapy - Regimen U|Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984278|NCT00977431|OG004|Outcome|Afatinib 40 mg, Radiotherapy - Regimen U|Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984279|NCT00977431|OG000|Outcome|Total - Regimen M|Patients were administered Afatinib 20/30/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984280|NCT00977431|OG001|Outcome|Total - Regimen U|Patients were administered Afatinib 20/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984281|NCT00977431|EG000|Reported Event|Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
11007185|NCT01089608|FG001|Participant Flow|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
11007186|NCT01089608|OG000|Outcome|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
10984282|NCT00977431|EG001|Reported Event|Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984283|NCT00977431|EG002|Reported Event|Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M|Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984284|NCT00977431|EG003|Reported Event|Total - Regimen M|Patients were administered Afatinib 20/30/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
10984285|NCT00977431|EG004|Reported Event|Afatinib 20 mg, Radiotherapy - Regimen U|Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984286|NCT00977431|EG005|Reported Event|Afatinib 40 mg, Radiotherapy - Regimen U|Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984287|NCT00977431|EG006|Reported Event|Total - Regimen U|Patients were administered Afatinib 20/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
10984288|NCT00977470|BG000|Baseline|Erlotinib|Erlotinib: 150 mg taken orally once daily
10984289|NCT00977470|BG001|Baseline|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
10984290|NCT00977470|BG002|Baseline|Total|Total of all reporting groups
10984291|NCT00977470|FG000|Participant Flow|Erlotinib|Erlotinib: 150 mg taken orally once daily
10984292|NCT00977470|FG001|Participant Flow|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
10984293|NCT00977470|OG000|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
10984294|NCT00977470|OG001|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
10984295|NCT00977470|EG000|Reported Event|Erlotinib|Erlotinib: 150 mg taken orally once daily
10984296|NCT00977470|EG001|Reported Event|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
10984297|NCT00977548|BG000|Baseline|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
10984298|NCT00977548|FG000|Participant Flow|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
10984299|NCT00977548|OG000|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
10984300|NCT00977548|EG000|Reported Event|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
10984301|NCT00977561|BG000|Baseline|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Day 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984302|NCT00977561|BG001|Baseline|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984303|NCT00977561|BG002|Baseline|Total|Total of all reporting groups
10984304|NCT00977561|FG000|Participant Flow|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 milligram/kilogram (mg/kg) administered intravenously (IV) over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 milligram/square meter (mg/m^2) IV over 1 hour or carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 5 milligram/milliliter*minute (mg/mL*min) IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984305|NCT00977561|FG001|Participant Flow|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984306|NCT00977561|OG000|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984307|NCT00977561|OG001|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984308|NCT00977561|OG000|Outcome|Figitumumab+ Cisplatin (or Carboplatin) + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984309|NCT00977561|OG000|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Participants who received figitumumab, whether figitumumab (20 mg/kg, IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles) was given in combination with cisplatin (75 mg/m^2 IV over 1 hour on Day 1 of each cycle) or carboplatin (AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 of each cycle) followed by etoposide (100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle) from the beginning or figitumumab was given as a single agent after documented disease progression with cisplatin (or carboplatin) and etoposide. When given as a single agent, figitumumab was administered as IV infusion on Days 1 and 2 of the initial cycle and on Day 1 of subsequent cycles, up to 17 cycles in the absence of further disease progression or intolerable toxicity. Each cycle was 21 days cycle.
10984310|NCT00977561|EG000|Reported Event|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984311|NCT00977561|EG001|Reported Event|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
10984312|NCT00977613|BG000|Baseline|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
10984313|NCT00977613|FG000|Participant Flow|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
10984314|NCT00977613|OG000|Outcome|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
10984315|NCT00977613|EG000|Reported Event|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
10984316|NCT00977665|BG000|Baseline|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
10984317|NCT00977665|BG001|Baseline|Placebo|placebo tablet for up to 48 weeks.
10984318|NCT00977665|BG002|Baseline|Total|Total of all reporting groups
10984319|NCT00977665|FG000|Participant Flow|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
10984320|NCT00977665|FG001|Participant Flow|Placebo|placebo tablet for up to 48 weeks.
10984321|NCT00977665|OG000|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
10984322|NCT00977665|OG001|Outcome|Placebo|placebo tablet for up to 48 weeks.
10984323|NCT00977665|EG000|Reported Event|Placebo|Placebo tablet for up to 48 weeks.
10984324|NCT00977665|EG001|Reported Event|Rasagiline Mesylate|Rasagiline tablet, 1 mg/day for up to 48 weeks.
10984325|NCT00977704|BG000|Baseline|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
10984326|NCT00977704|FG000|Participant Flow|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
10984327|NCT00977704|OG000|Outcome|Restylane and Perlane|Single arm safety study of subjects receiving Restylane and Perlane.
10984328|NCT00977704|EG000|Reported Event|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
10984329|NCT00977769|BG000|Baseline|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
10984330|NCT00977769|BG001|Baseline|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
10984331|NCT00977769|BG002|Baseline|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
10984332|NCT00977769|BG003|Baseline|Total|Total of all reporting groups
10984333|NCT00977769|FG000|Participant Flow|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
10984334|NCT00977769|FG001|Participant Flow|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
10984335|NCT00977769|FG002|Participant Flow|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
10984336|NCT00977769|OG000|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
10984337|NCT00977769|OG001|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
10984338|NCT00977769|OG002|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
10984339|NCT00977769|EG000|Reported Event|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
10984340|NCT00977769|EG001|Reported Event|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
10984341|NCT00977769|EG002|Reported Event|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
10984342|NCT00977808|BG000|Baseline|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
10984343|NCT00977808|FG000|Participant Flow|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
10984344|NCT00977808|OG000|Outcome|Experimental: Closed-Loop Model Predictive Control (MPC)|Insulin dosing was performed by a model-predictive control (MPC) algorithm.
10984345|NCT00977808|OG001|Outcome|Control: Open-Loop|Insulin dosing was performed by the patient (using their normal routine and personal insulin pump) under a physician's supervision.
10984346|NCT00977808|EG000|Reported Event|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
10984347|NCT00977938|BG000|Baseline|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
10984348|NCT00977938|BG001|Baseline|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
10984349|NCT00977938|BG002|Baseline|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
10984350|NCT00977938|BG003|Baseline|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
10984351|NCT00977938|BG004|Baseline|Total|Total of all reporting groups
10984352|NCT00977938|FG000|Participant Flow|DES 30-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
10984353|NCT00977938|FG001|Participant Flow|DES 12-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
10984354|NCT00977938|FG002|Participant Flow|BMS 30-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
10984355|NCT00977938|FG003|Participant Flow|BMS 12-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
10984356|NCT00977938|OG000|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
10875131|NCT00436644|BG000|Baseline|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
10875132|NCT00436644|FG000|Participant Flow|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
10875133|NCT00436644|OG000|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
10875134|NCT00436644|EG000|Reported Event|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
10875135|NCT00436748|BG000|Baseline|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
10875136|NCT00436748|BG001|Baseline|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
10875137|NCT00436748|BG002|Baseline|Total|Total of all reporting groups
10875138|NCT00436748|FG000|Participant Flow|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
10875139|NCT00436748|FG001|Participant Flow|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
10875140|NCT00436748|OG000|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
10875141|NCT00436748|OG001|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
10875142|NCT00436748|EG000|Reported Event|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
10875143|NCT00436748|EG001|Reported Event|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
10875144|NCT00436852|BG000|Baseline|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
10875145|NCT00436852|BG001|Baseline|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
10875146|NCT00436852|BG002|Baseline|Total|Total of all reporting groups
10875147|NCT00436852|FG000|Participant Flow|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
10875148|NCT00436852|FG001|Participant Flow|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
10875149|NCT00436852|OG000|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
10875150|NCT00436852|OG001|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
10984357|NCT00977938|OG001|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
10984358|NCT00977938|OG000|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
10984359|NCT00977938|OG001|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
10984360|NCT00977938|OG000|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
10984361|NCT00977938|OG001|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
10984362|NCT00977938|EG000|Reported Event|HCRI DAPT - DES 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
10984363|NCT00977938|EG001|Reported Event|HCRI DAPT - DES 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
10984364|NCT00977938|EG002|Reported Event|HCRI DAPT - BMS 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
10984365|NCT00977938|EG003|Reported Event|HCRI DAPT - BMS 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
10984366|NCT00978029|BG000|Baseline|Placebo|Matching placebo tablet sublingual, once daily
10984367|NCT00978029|BG001|Baseline|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
10984368|NCT00978029|BG002|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
10984369|NCT00978029|BG003|Baseline|Total|Total of all reporting groups
10984370|NCT00978029|FG000|Participant Flow|Placebo|Matching placebo tablet sublingual, once daily
10984371|NCT00978029|FG001|Participant Flow|SCH 39641 6 Amb a 1-U|6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily
10984372|NCT00978029|FG002|Participant Flow|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
10984373|NCT00978029|OG000|Outcome|Placebo|Matching placebo tablet sublingual, once daily
10984374|NCT00978029|OG001|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
10984375|NCT00978029|OG002|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
10984376|NCT00978029|EG000|Reported Event|Placebo|Matching placebo tablet sublingual, once daily
10984377|NCT00978029|EG001|Reported Event|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
10984378|NCT00978029|EG002|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
10984379|NCT00978042|BG000|Baseline|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
10984380|NCT00978042|BG001|Baseline|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
10984381|NCT00978042|BG002|Baseline|Total|Total of all reporting groups
10984382|NCT00978042|FG000|Participant Flow|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
10984383|NCT00978042|FG001|Participant Flow|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
10984384|NCT00978042|OG000|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
10984385|NCT00978042|OG001|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
10984386|NCT00978042|EG000|Reported Event|All Treated Participants_ AEs Initial Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment.
11007187|NCT01089608|OG001|Outcome|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
10984387|NCT00978042|EG001|Reported Event|All Treated Participants_ AEs After Repeat Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment.
10984388|NCT00978068|BG000|Baseline|LPV/r + 2 NRTIs|"LPV/r + 2 NRTIs: Group 1~Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)~The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons."
10984389|NCT00978068|BG001|Baseline|NVP or EFV + 2 NRTIs|"NVP or EFV + 2 NRTIs: Group 2~Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI~NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine."
10984390|NCT00978068|BG002|Baseline|Total|Total of all reporting groups
10984391|NCT00978068|FG000|Participant Flow|LPV/r + 2 NRTIs|"LPV/r + 2 NRTIs: Group 1~Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)~The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons."
10984392|NCT00978068|FG001|Participant Flow|NVP or EFV + 2 NRTIs|"NVP or EFV + 2 NRTIs: Group 2~Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI~NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine."
10984393|NCT00978068|OG000|Outcome|Group 1: LPV/r + 2 NRTIs|"Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)~The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons."
10984394|NCT00978068|OG001|Outcome|Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs|NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.
10984395|NCT00978068|OG000|Outcome|LPV/r + 2 NRTIs|"LPV/r + 2 NRTIs: Group 1~Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)~The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons."
10984396|NCT00978068|OG001|Outcome|NVP or EFV + 2 NRTIs|"NVP or EFV + 2 NRTIs: Group 2~Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI~NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine."
10984397|NCT00978068|OG000|Outcome|Group 1|"LPV/r + 2 NRTIs~LPV/r + 2 NRTIs: Group 1~Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)~The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons."
10984398|NCT00978068|OG001|Outcome|Group 2|"NVP or EFV + 2 NRTIs~NVP or EFV + 2 NRTIs: Group 2~Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI~NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine."
10984399|NCT00978068|EG000|Reported Event|Group 1|"LPV/r + 2 NRTIs~LPV/r + 2 NRTIs: Group 1~Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)~The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons."
10984400|NCT00978068|EG001|Reported Event|Group 2|"NVP or EFV + 2 NRTIs~NVP or EFV + 2 NRTIs: Group 2~Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI~NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine."
10984401|NCT00978120|BG000|Baseline|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984402|NCT00978120|BG001|Baseline|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
10984403|NCT00978120|BG002|Baseline|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984404|NCT00978120|BG003|Baseline|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
10984405|NCT00978120|BG004|Baseline|Total|Total of all reporting groups
10984406|NCT00978120|FG000|Participant Flow|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984407|NCT00978120|FG001|Participant Flow|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
10984408|NCT00978120|FG002|Participant Flow|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984409|NCT00978120|FG003|Participant Flow|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
10984410|NCT00978120|OG000|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984411|NCT00978120|OG001|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
10984412|NCT00978120|OG002|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984413|NCT00978120|OG003|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
10984414|NCT00978120|OG000|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984415|NCT00978120|OG001|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
10984416|NCT00978120|OG000|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984417|NCT00978120|OG001|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
10984418|NCT00978120|EG000|Reported Event|Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)|Participants with mild/moderate asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984419|NCT00978120|EG001|Reported Event|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild/moderate asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984420|NCT00978120|EG002|Reported Event|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984421|NCT00978120|EG003|Reported Event|Severe Asthma, High Dose Vaccine (30mcg)|Participants with severe asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
10984422|NCT00978250|BG000|Baseline|Non-Small Cell Lung Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes."
10984423|NCT00978250|BG001|Baseline|Breast Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes."
11007188|NCT01089608|EG000|Reported Event|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
10875151|NCT00436852|OG000|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients with evaluable disease by (123)I-MIBG scintigraphy (positive at a minimum of one site) with or without bone marrow metastases but without RECIST (Response Evaluation in Solid Tumors) measureable disease.
10875152|NCT00436852|OG001|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients with RECIST measurable disease on CT or MRI scan, with or without (123)I-MIBG positive disease, with or without bone marrow metastases.
10875153|NCT00436852|OG000|Outcome|All Eligible Patients|All eligible patients who received the first dose of ABT-751 and participated in the pharmacokinetic studies
10875154|NCT00436852|EG000|Reported Event|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
10875155|NCT00436852|EG001|Reported Event|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
10875156|NCT00436904|BG000|Baseline|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
10875157|NCT00436904|FG000|Participant Flow|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
10875158|NCT00436904|OG000|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
10875159|NCT00436904|EG000|Reported Event|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
10875160|NCT00436917|BG000|Baseline|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
10875161|NCT00436917|FG000|Participant Flow|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
10875162|NCT00436917|OG000|Outcome|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
10875163|NCT00436917|EG000|Reported Event|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
10875164|NCT00436956|BG000|Baseline|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
10875165|NCT00436956|FG000|Participant Flow|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
10875166|NCT00436956|FG001|Participant Flow|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
10875167|NCT00436956|OG000|Outcome|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
10875168|NCT00436956|OG000|Outcome|All Participants- AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
10875169|NCT00436956|OG000|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
10875170|NCT00436956|OG001|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
10875171|NCT00436956|EG000|Reported Event|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
10875172|NCT00436969|BG000|Baseline|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
10875173|NCT00436969|BG001|Baseline|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
10875174|NCT00436969|BG002|Baseline|Total|Total of all reporting groups
10875175|NCT00436969|FG000|Participant Flow|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
10875176|NCT00436969|FG001|Participant Flow|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
10875177|NCT00436969|OG000|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
10875178|NCT00436969|OG001|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
10875179|NCT00436969|EG000|Reported Event|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).
10875180|NCT00436969|EG001|Reported Event|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
10875181|NCT00436982|BG000|Baseline|Triathlon|30 patients randomized into the Triathlon arm
10875182|NCT00436982|BG001|Baseline|Duracon|30 patients randomized into the Duracon arm
10875183|NCT00436982|BG002|Baseline|Total|Total of all reporting groups
10875184|NCT00436982|FG000|Participant Flow|Cemented Triathlon Total Knee System|"30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Cemented Triathlon total knee system: Orthopaedic implant"
10875185|NCT00436982|FG001|Participant Flow|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
10875186|NCT00436982|OG000|Outcome|Triathlon|30 patients randomized into the Triathlon arm
10875187|NCT00436982|OG001|Outcome|Duracon|30 patients randomized into the Duracon arm
10984424|NCT00978250|BG002|Baseline|Bladder Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes."
10984425|NCT00978250|BG003|Baseline|Head and Neck Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes."
10984426|NCT00978250|BG004|Baseline|Total|Total of all reporting groups
10984427|NCT00978250|FG000|Participant Flow|Non-Small Cell Lung Cancer Stratum|FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.
10984428|NCT00978250|FG001|Participant Flow|Breast Cancer Stratum|FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.
10984429|NCT00978250|FG002|Participant Flow|Bladder Cancer Stratum|FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.
10984430|NCT00978250|FG003|Participant Flow|Head and Neck Cancer Stratum|FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.
10984431|NCT00978250|OG000|Outcome|Non-Small Cell Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984432|NCT00978250|OG001|Outcome|Breast Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984433|NCT00978250|OG002|Outcome|Bladder Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984434|NCT00978250|OG003|Outcome|Heand and Neck Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984435|NCT00978250|OG000|Outcome|Non-Small Cell Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
11007189|NCT01089608|EG001|Reported Event|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
11007190|NCT01089647|BG000|Baseline|Placebo|"sugar pill, salt water nasal spray~Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks"
11007191|NCT01089647|BG001|Baseline|Budesonide and Montelukast|"treatment arm~budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks"
10984436|NCT00978250|OG001|Outcome|Breast Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984437|NCT00978250|OG002|Outcome|Bladder Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984438|NCT00978250|OG003|Outcome|Head and Neck Cancer Stratum|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984439|NCT00978250|OG000|Outcome|5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984440|NCT00978250|EG000|Reported Event|5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)|"FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles~5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes."
10984441|NCT00978341|BG000|Baseline|All Subjects|Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning; and Placebo: Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
10984442|NCT00978341|FG000|Participant Flow|Pregabalin First Then Placebo|First Intervention Pregabalin Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. Second Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
10984443|NCT00978341|FG001|Participant Flow|Placebo First Then Pregabalin|First Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. Second Intervention Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
10984444|NCT00978341|OG000|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
10984445|NCT00978341|OG001|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning
10984446|NCT00978341|OG001|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
10984447|NCT00978341|EG000|Reported Event|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
10984448|NCT00978341|EG001|Reported Event|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
10984449|NCT00978380|BG000|Baseline|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
10984450|NCT00978380|FG000|Participant Flow|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
11007192|NCT01089647|BG002|Baseline|Total|Total of all reporting groups
11007193|NCT01089647|FG000|Participant Flow|Budesonide and Montelukast|"treatment arm~budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks"
11007194|NCT01089647|FG001|Participant Flow|Placebo|"sugar pill, salt water nasal spray~Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks"
10984451|NCT00978380|OG000|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
10984452|NCT00978380|EG000|Reported Event|rFXIII Novo Nordisk|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Novo Nordisk drug.
10984453|NCT00978380|EG001|Reported Event|rFXIII Avecia|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Avecia drug.
10984454|NCT00978432|BG000|Baseline|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
10984455|NCT00978432|BG001|Baseline|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
10984456|NCT00978432|BG002|Baseline|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
10984457|NCT00978432|BG003|Baseline|Total|Total of all reporting groups
10984458|NCT00978432|FG000|Participant Flow|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
10984459|NCT00978432|FG001|Participant Flow|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
10984460|NCT00978432|FG002|Participant Flow|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
10984461|NCT00978432|OG000|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
10984462|NCT00978432|OG001|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
10984463|NCT00978432|OG002|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
10984464|NCT00978432|EG000|Reported Event|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
10984465|NCT00978432|EG001|Reported Event|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
10984466|NCT00978432|EG002|Reported Event|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
10984467|NCT00978445|BG000|Baseline|All Participants|all participants recieved all interventions during study
10984468|NCT00978445|FG000|Participant Flow|Home/Standard|all participants recieved home and standard protocol, in this ARM the home protocol was a virtual INR and communication using a remote communication device called vMetrics.
10984469|NCT00978445|FG001|Participant Flow|Standard/Home|all participants recieved home and standard protocol, in this ARM the standard protocol was a in clinic INR and interaction with a care giver, then the Home protocol was as described.
10984470|NCT00978445|OG000|Outcome|All Participants-Home Protocol|all participants recieved all interventions during study
10984471|NCT00978445|OG001|Outcome|All Particpants - Standard Protocol|First and second group with vMetrics
10984472|NCT00978445|OG000|Outcome|All Participants-home Protocol|all participants recieved all interventions during study
10984473|NCT00978445|OG001|Outcome|All Participants - Standard Protocol|all participants recieved all interventions during study
10984474|NCT00978445|EG000|Reported Event|All Participants|all participants recieved all interventions during study
10984475|NCT00978562|BG000|Baseline|Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium)|"Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI~Ferumoxytol Non-Stoichiometric Magnetite: Given IV~Gadolinium: Given IV"
10984476|NCT00978562|FG000|Participant Flow|Ferumoxytol Dynamic Susceptibility (DSC) Weighted MRI and Gado|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
10984477|NCT00978562|OG000|Outcome|Ferumoxytol DSC MRI|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
10984478|NCT00978562|OG000|Outcome|Gadolinium DCE|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
10984479|NCT00978562|EG000|Reported Event|Ferumoxytol DSC and Gad DCE MRI|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
10984480|NCT00978627|BG000|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
10984481|NCT00978627|BG001|Baseline|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
10984482|NCT00978627|BG002|Baseline|Total|Total of all reporting groups
10984483|NCT00978627|FG000|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
10984484|NCT00978627|FG001|Participant Flow|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
10984485|NCT00978627|OG000|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
10984486|NCT00978627|OG001|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
10984487|NCT00978627|EG000|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
10984488|NCT00978627|EG001|Reported Event|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
10984489|NCT00978731|BG000|Baseline|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984490|NCT00978731|BG001|Baseline|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984491|NCT00978731|BG002|Baseline|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984492|NCT00978731|BG003|Baseline|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984493|NCT00978731|BG004|Baseline|Total|Total of all reporting groups
10984494|NCT00978731|FG000|Participant Flow|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984495|NCT00978731|FG001|Participant Flow|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984496|NCT00978731|FG002|Participant Flow|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984497|NCT00978731|FG003|Participant Flow|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984498|NCT00978731|OG000|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984499|NCT00978731|OG001|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984500|NCT00978731|OG002|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984501|NCT00978731|OG003|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984502|NCT00978731|OG000|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984503|NCT00978731|OG000|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984504|NCT00978731|OG001|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984505|NCT00978731|OG000|Outcome|All Participants|All participants treated in each arm of the study were included.
10984506|NCT00978731|EG000|Reported Event|Participants With Accelerated Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
11007195|NCT01089647|OG000|Outcome|Budesonide and Montelukast|"treatment arm~budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks"
11007196|NCT01089647|OG001|Outcome|Placebo|"sugar pill, salt water nasal spray~Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks"
10846350|NCT00275002|EG001|Reported Event|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
11007197|NCT01089647|EG000|Reported Event|Budesonide and Montelukast|"treatment arm~budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks"
11007198|NCT01089647|EG001|Reported Event|Placebo|"sugar pill, salt water nasal spray~Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks"
10846351|NCT00275028|BG000|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10846352|NCT00275028|FG000|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10846353|NCT00275028|OG000|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10846354|NCT00275028|EG000|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10846355|NCT00275262|BG000|Baseline|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
10846356|NCT00275262|BG001|Baseline|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
10846357|NCT00275262|BG002|Baseline|Total|Total of all reporting groups
10846358|NCT00275262|FG000|Participant Flow|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
10846359|NCT00275262|FG001|Participant Flow|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
10846360|NCT00275262|OG000|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
10846361|NCT00275262|OG001|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
10846362|NCT00275262|EG000|Reported Event|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
10846363|NCT00275262|EG001|Reported Event|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
10846364|NCT00275275|BG000|Baseline|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
10846365|NCT00275275|BG001|Baseline|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
10846366|NCT00275275|BG002|Baseline|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
10846367|NCT00275275|BG003|Baseline|Total|Total of all reporting groups
10846368|NCT00275275|FG000|Participant Flow|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
10846369|NCT00275275|FG001|Participant Flow|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
10846370|NCT00275275|FG002|Participant Flow|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
10846371|NCT00275275|OG000|Outcome|Preferred Requip PR|This group refers to the subjects that preferred Requip PR to Mirapex
10846372|NCT00275275|OG001|Outcome|Preferred Mirapex|This group refers to the subjects that preferred Mirapex
10846373|NCT00275275|OG000|Outcome|Preferred Requip PR|This is the group of subjects that preferred Requip PR to Mirapex
10846374|NCT00275275|OG001|Outcome|Preferred Mirapex|This is the group that preferred Mirapex to Requip PR
10846375|NCT00275275|EG000|Reported Event|Preferred Requip PR|These are the subjects that preferred Requip PR to Mirapex at the end of the study
10846376|NCT00275275|EG001|Reported Event|Preferred Mirapex|These are the subjects that preferred Mirapex to Requip PR at the end of the study
10846377|NCT00275301|BG000|Baseline|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
10846378|NCT00275301|FG000|Participant Flow|All Subjects Took Open-label Olanzapine.|All subjects took open-label olanzapine. Subjects tritrated to up to 10mg
10846379|NCT00275301|OG000|Outcome|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
10846380|NCT00275301|EG000|Reported Event|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
10846381|NCT00275392|BG000|Baseline|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
10846382|NCT00275392|BG001|Baseline|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
10846383|NCT00275392|BG002|Baseline|Total|Total of all reporting groups
10846384|NCT00275392|FG000|Participant Flow|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
10846385|NCT00275392|FG001|Participant Flow|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
10846386|NCT00275392|OG000|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
10984507|NCT00978731|EG001|Reported Event|Participants With Chronic Myelogenous Leukemia(CML);QD Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules: 5 days, on 2 days off; 6 days on, 1 day off; or continuous daily dosing. Participants were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to twice daily (BID) dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984508|NCT00978731|EG002|Reported Event|Participants With CML; BID Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984509|NCT00978731|EG003|Reported Event|Participants With Myeloid Blast Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
10984510|NCT00978757|BG000|Baseline|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
10984511|NCT00978757|BG001|Baseline|Placebo|Placebo: saline solution
10984512|NCT00978757|BG002|Baseline|Total|Total of all reporting groups
10984513|NCT00978757|FG000|Participant Flow|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
10984514|NCT00978757|FG001|Participant Flow|Placebo|Placebo: saline solution
10984515|NCT00978757|OG000|Outcome|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
10984516|NCT00978757|OG001|Outcome|Placebo|Placebo: saline solution
10984517|NCT00978757|EG000|Reported Event|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
10984518|NCT00978757|EG001|Reported Event|Placebo|Placebo: saline solution
10984519|NCT00979017|BG000|Baseline|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
10984520|NCT00979017|FG000|Participant Flow|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
10984521|NCT00979017|OG000|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
10984522|NCT00979017|EG000|Reported Event|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
10984523|NCT00979069|BG000|Baseline|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
10984524|NCT00979069|BG001|Baseline|Control Group|No contact control
10984525|NCT00979069|BG002|Baseline|Total|Total of all reporting groups
10984526|NCT00979069|FG000|Participant Flow|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
10984527|NCT00979069|FG001|Participant Flow|Control Group|No contact control
10984528|NCT00979069|OG000|Outcome|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
10984529|NCT00979069|OG001|Outcome|Control Group|No contact control
10984530|NCT00979069|EG000|Reported Event|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
10984531|NCT00979069|EG001|Reported Event|Control Group|No contact control
10984532|NCT00979121|BG000|Baseline|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
10984533|NCT00979121|BG001|Baseline|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
10984534|NCT00979121|BG002|Baseline|Total|Total of all reporting groups
10846387|NCT00275392|OG001|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
10984535|NCT00979121|FG000|Participant Flow|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
10984536|NCT00979121|FG001|Participant Flow|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
10984537|NCT00979121|OG000|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
10984538|NCT00979121|OG001|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
10984539|NCT00979121|OG001|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital."
10984540|NCT00979121|OG000|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Patients received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
10984541|NCT00979121|OG000|Outcome|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
10984542|NCT00979121|OG001|Outcome|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
10984543|NCT00979121|OG000|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin:Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
10984544|NCT00979121|EG000|Reported Event|Rosuvastatin|"Half of the subjects were randomized to the active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
10984545|NCT00979121|EG001|Reported Event|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
10984546|NCT00979134|BG000|Baseline|Part B|Dose expansion phase (80mg bd tablet)
10984547|NCT00979134|BG001|Baseline|Part C (FISH Ratio >= 2)|Dose expansion in patients with FGFR gene-amplified tumours
10984548|NCT00979134|BG002|Baseline|Part C (FISH Ratio < 2 )|Dose expansion in patients with FGFR gene-amplified tumours
10984549|NCT00979134|BG003|Baseline|Part A|Dose escalation
10984550|NCT00979134|BG004|Baseline|Total|Total of all reporting groups
10984551|NCT00979134|FG000|Participant Flow|Part A|Dose escalation
10984552|NCT00979134|FG001|Participant Flow|Part B|Dose expansion phase (80mg bd tablet)
10984553|NCT00979134|FG002|Participant Flow|Part C|Dose expansion in patients with FGFR gene-amplified tumours
10984554|NCT00979134|OG000|Outcome|Part B|Dose expansion phase (80mg bd tablet)
10984555|NCT00979134|OG001|Outcome|Part C (FISH Ratio >= 2)|Dose expansion in patients with FGFR gene-amplified tumours
10984556|NCT00979134|OG002|Outcome|Part C (FISH Ratio < 2)|Dose expansion in patients with FGFR gene-amplified tumours
10984557|NCT00979134|OG003|Outcome|Part A|Dose escalation
10984558|NCT00979134|OG002|Outcome|Part A|Dose escalation
10984559|NCT00979134|OG003|Outcome|Part C (FISH Ratio < 2)|Dose expansion in patients with FGFR gene-amplified tumours
10984560|NCT00979134|OG002|Outcome|Part C (FISH Ratio <2)|Dose expansion in patients with FGFR gene-amplified tumours
10984561|NCT00979134|EG000|Reported Event|Part B|Dose expansion phase (80mg bd tablet)
10984562|NCT00979134|EG001|Reported Event|Part C (FISH Ratio >= 2)|Dose expansion in patients with FGFR gene-amplified tumours
10984563|NCT00979134|EG002|Reported Event|Part C (FISH Ratio < 2)|Dose expansionj in patients with FGFR gene-amplified tumours
10984564|NCT00979134|EG003|Reported Event|Part A|Dose escalation
10984565|NCT00979199|BG000|Baseline|CTCA and PET or SPECT and ECHO or MRI|
10984566|NCT00979199|FG000|Participant Flow|CTCA and PET or SPECT and ECHO or MRI|
10984567|NCT00979199|OG000|Outcome|Non Invasive Cardiac Imaging|All patients are submitted to non invasive cardiac imaging. 'Anatomical' information provided by CTA is obtained in every patient together with the 'functional' information provided by stress radionuclide cardiac imaging (SPECT or PET), to assess myocardial perfusion, and/or by stress MRI or ECHO imaging to assess myocardial contraction. All patients with at least one positive functional test undergo invasive coronary angiography to obtain the final diagnosis of IHD (Outcome measurement).
10984568|NCT00979199|EG000|Reported Event|Non Invasive Cardiac Imaging|
10984569|NCT00979303|BG000|Baseline|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
10984570|NCT00979303|BG001|Baseline|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
10984571|NCT00979303|BG002|Baseline|Total|Total of all reporting groups
10984572|NCT00979303|FG000|Participant Flow|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
10984573|NCT00979303|FG001|Participant Flow|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
10984574|NCT00979303|OG000|Outcome|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
10984575|NCT00979303|OG001|Outcome|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
10984576|NCT00979303|EG000|Reported Event|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
10984577|NCT00979303|EG001|Reported Event|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
11007199|NCT01089725|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007200|NCT01089725|BG001|Baseline|Tanezumab 2.5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007201|NCT01089725|BG002|Baseline|Tanezumab 5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007202|NCT01089725|BG003|Baseline|Tanezumab 10 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007203|NCT01089725|BG004|Baseline|Tanezumab 10 mg Intravenous Infusion|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
11007204|NCT01089725|BG005|Baseline|Total|Total of all reporting groups
11007205|NCT01089725|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007206|NCT01089725|FG001|Participant Flow|Tanezumab 2.5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007207|NCT01089725|FG002|Participant Flow|Tanezumab 5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007208|NCT01089725|FG003|Participant Flow|Tanezumab 10 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007209|NCT01089725|FG004|Participant Flow|Tanezumab 10 mg Intravenous Infusion|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
11007210|NCT01089725|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007211|NCT01089725|OG001|Outcome|Tanezumab 2.5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007212|NCT01089725|OG002|Outcome|Tanezumab 5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007213|NCT01089725|OG003|Outcome|Tanezumab 10 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007214|NCT01089725|OG004|Outcome|Tanezumab 10 mg Intravenous Infusion|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
11007215|NCT01089725|OG000|Outcome|Tanezumab 2.5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007216|NCT01089725|OG001|Outcome|Tanezumab 5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007217|NCT01089725|OG002|Outcome|Tanezumab 10 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007218|NCT01089725|OG003|Outcome|Tanezumab 10 mg Intravenous Infusion|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
11007219|NCT01089725|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007220|NCT01089725|EG001|Reported Event|Tanezumab 2.5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
10984578|NCT00979407|BG000|Baseline|GSK2340272A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984579|NCT00979407|BG001|Baseline|GSK2340274A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984580|NCT00979407|BG002|Baseline|Total|Total of all reporting groups
10984581|NCT00979407|FG000|Participant Flow|GSK2340272A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984582|NCT00979407|FG001|Participant Flow|GSK2340274A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984583|NCT00979407|OG000|Outcome|GSK2340272A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984584|NCT00979407|OG001|Outcome|GSK2340274A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984585|NCT00979407|OG000|Outcome|GSK2340274A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984586|NCT00979407|OG001|Outcome|GSK2340272A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984587|NCT00979407|EG000|Reported Event|GSK2340272A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984588|NCT00979407|EG001|Reported Event|GSK2340274A GROUP|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10984589|NCT00979420|BG000|Baseline|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
10984590|NCT00979420|BG001|Baseline|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
10984591|NCT00979420|BG002|Baseline|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
10984592|NCT00979420|BG003|Baseline|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
10846388|NCT00275392|EG000|Reported Event|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
10984593|NCT00979420|BG004|Baseline|Total|Total of all reporting groups
10984594|NCT00979420|FG000|Participant Flow|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
10984595|NCT00979420|FG001|Participant Flow|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
10984596|NCT00979420|FG002|Participant Flow|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
10984597|NCT00979420|FG003|Participant Flow|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
10984598|NCT00979420|OG000|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
10984599|NCT00979420|OG001|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
10984600|NCT00979420|OG002|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
10984601|NCT00979420|OG003|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
10984602|NCT00979420|OG001|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
10984603|NCT00979420|EG000|Reported Event|Viramune|
10984604|NCT00979459|BG000|Baseline|All Participants|Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC
10984605|NCT00979459|FG000|Participant Flow|MK-1006 DFC, Then MK-1006 FCT|Participants received a single dose of four 20 mg MK-1006 dry filled capsules (DFC) followed by a single dose of two 40 mg MK-1006 film coated tablets (FCT) after a 7 day washout period.
10984606|NCT00979459|FG001|Participant Flow|MK-1006 FCT, Then MK-1006 DFC|Participants received a single dose of two 40 mg film coated tablets (FCT) of MK-1006 followed by a single dose of four 20 mg MK-1006 dry filled capsules (DFC) after a 7 day washout period.
10984607|NCT00979459|OG000|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
10984608|NCT00979459|OG001|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
10984609|NCT00979459|OG000|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
10984610|NCT00979459|OG001|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
10984611|NCT00979459|EG000|Reported Event|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
10984612|NCT00979459|EG001|Reported Event|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
10984613|NCT00979576|BG000|Baseline|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
10984614|NCT00979576|BG001|Baseline|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
10984615|NCT00979576|BG002|Baseline|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
10984616|NCT00979576|BG003|Baseline|Total|Total of all reporting groups
10984617|NCT00979576|FG000|Participant Flow|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
10984618|NCT00979576|FG001|Participant Flow|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
10984619|NCT00979576|FG002|Participant Flow|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
10984620|NCT00979576|OG000|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
10984621|NCT00979576|OG001|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
10984622|NCT00979576|OG002|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
10984623|NCT00979576|OG000|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
10846389|NCT00275392|EG001|Reported Event|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
10846390|NCT00275509|BG000|Baseline|Tymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
10984624|NCT00979576|EG000|Reported Event|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
11007221|NCT01089725|EG002|Reported Event|Tanezumab 5 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
11007222|NCT01089725|EG003|Reported Event|Tanezumab 10 mg Subcutaneous Injection|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.
10984625|NCT00979576|EG001|Reported Event|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
10984626|NCT00979576|EG002|Reported Event|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
10984627|NCT00979602|BG000|Baseline|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984628|NCT00979602|BG001|Baseline|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984629|NCT00979602|BG002|Baseline|Total|Total of all reporting groups
10984630|NCT00979602|FG000|Participant Flow|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984631|NCT00979602|FG001|Participant Flow|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984632|NCT00979602|OG000|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984633|NCT00979602|OG001|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984634|NCT00979602|OG002|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984635|NCT00979602|OG003|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984636|NCT00979602|OG004|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984637|NCT00979602|OG005|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984638|NCT00979602|OG006|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984639|NCT00979602|OG007|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984640|NCT00979602|OG000|Outcome|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984641|NCT00979602|OG001|Outcome|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984642|NCT00979602|OG000|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984643|NCT00979602|OG001|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984644|NCT00979602|OG002|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984645|NCT00979602|OG003|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
11007223|NCT01089725|EG004|Reported Event|Tanezumab 10 mg Intravenous Infusion|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
10846391|NCT00275509|BG001|Baseline|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
10984646|NCT00979602|EG000|Reported Event|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984647|NCT00979602|EG001|Reported Event|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
10984648|NCT00979615|BG000|Baseline|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
10984649|NCT00979615|BG001|Baseline|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
10984650|NCT00979615|BG002|Baseline|Total|Total of all reporting groups
10984651|NCT00979615|FG000|Participant Flow|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
10984652|NCT00979615|FG001|Participant Flow|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
10984653|NCT00979615|OG000|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
10984654|NCT00979615|OG001|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
10984655|NCT00979615|EG000|Reported Event|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
10984656|NCT00979615|EG001|Reported Event|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
10984657|NCT00979628|BG000|Baseline|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals subcut at an initial dose of 0.3-0.5 units/kg/day (plus corrective doses of glulisine as needed)"
10984658|NCT00979628|BG001|Baseline|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily subcut at an initial dose of 0.15-0.25 units/kg/day plus corrective doses of glulisine subcut before meals and bedtime as needed"
10984659|NCT00979628|BG002|Baseline|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) given subcut four-times daily before meals and at bedtime"
10984660|NCT00979628|BG003|Baseline|Total|Total of all reporting groups
10984661|NCT00979628|FG000|Participant Flow|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
10984662|NCT00979628|FG001|Participant Flow|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
10984663|NCT00979628|FG002|Participant Flow|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) : four-time daily in patients with T2DM admitted to general medicine and surgery wards."
10984664|NCT00979628|OG000|Outcome|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
10984665|NCT00979628|OG001|Outcome|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
10984666|NCT00979628|OG002|Outcome|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with type 2 diabetes mellitus (T2DM) admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
10846392|NCT00275509|BG002|Baseline|Total|Total of all reporting groups
10984667|NCT00979628|OG000|Outcome|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals subcut at an initial dose of 0.3-0.5 units/kg/day (plus corrective doses of glulisine as needed)"
10984668|NCT00979628|OG001|Outcome|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily subcut at an initial dose of 0.15-0.25 units/kg/day plus corrective doses of glulisine subcut before meals and bedtime as needed"
10984669|NCT00979628|OG002|Outcome|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) given subcut four-times daily before meals and at bedtime"
10984670|NCT00979628|EG000|Reported Event|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
10984671|NCT00979628|EG001|Reported Event|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
10984672|NCT00979628|EG002|Reported Event|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
10984673|NCT00979654|BG000|Baseline|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
10984674|NCT00979654|FG000|Participant Flow|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
10984675|NCT00979654|OG000|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
11007224|NCT01089751|BG000|Baseline|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
11007225|NCT01089751|BG001|Baseline|Placebo|Placebo once daily on an empty stomach for 14 weeks.
10984676|NCT00979654|EG000|Reported Event|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
10984677|NCT00979732|BG000|Baseline|GSE Beverage Active|"grape seed extract beverage 150 mg/BID~grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form"
10984678|NCT00979732|BG001|Baseline|GSE Beverage Placebo|"grape seed extract placebo beverage 150 mg/BID~grape seed extract placebo: grape seed extract 150 mg twice a day (BID) in beverage or capsule form"
10984679|NCT00979732|BG002|Baseline|Total|Total of all reporting groups
10984680|NCT00979732|FG000|Participant Flow|GSE Beverage Active|"grape seed extract beverage 150 mg/BID~grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form"
10984681|NCT00979732|FG001|Participant Flow|GSE Beverage Placebo|"grape seed extract placebo beverage 150 mg/BID~grape seed extract placebo: grape seed extract 150 mg twice a day (BID) in beverage or capsule form"
10984682|NCT00979732|OG000|Outcome|GSE Beverage Active|"grape seed extract beverage 150 mg/BID~grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form"
10984683|NCT00979732|OG001|Outcome|GSE Beverage Placebo|"grape seed extract placebo beverage 150 mg/BID~grape seed extract placebo: grape seed extract 150 mg twice a day (BID) in beverage or capsule form"
10984684|NCT00979732|EG000|Reported Event|GSE Beverage Active|"grape seed extract beverage 150 mg/BID~grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form"
10984685|NCT00979732|EG001|Reported Event|GSE Beverage Placebo|"grape seed extract placebo beverage 150 mg/BID~grape seed extract placebo: grape seed extract 150 mg twice a day (BID) in beverage or capsule form"
10984686|NCT00979745|BG000|Baseline|Experimental: Afamelanotide|administered afamelanotide implants on Days 0, 60, 120, 180 and 240.
10984687|NCT00979745|BG001|Baseline|Placebo|administered placebo implants on Days 0, 60, 120, 180 and 240.
10984688|NCT00979745|BG002|Baseline|Total|Total of all reporting groups
10984689|NCT00979745|FG000|Participant Flow|Experimental: Afamelanotide|administered afamelanotide implants on Days 0, 60, 120, 180 and 240.
10984690|NCT00979745|FG001|Participant Flow|Placebo|administered placebo implants on Days 0, 60, 120, 180 and 240.
10984691|NCT00979745|OG000|Outcome|Experimental: Afamelanotide|administered afamelanotide implants on Days 0, 60, 120, 180 and 240.
10984692|NCT00979745|OG001|Outcome|Placebo|administered placebo implants on Days 0, 60, 120, 180 and 240.
10984693|NCT00979745|EG000|Reported Event|Experimental: Afamelanotide|Afamelanotide implants administered on Days 0, 60, 120, 180 and 240.
10984694|NCT00979745|EG001|Reported Event|Placebo|Placebo implants administered on Days 0, 60, 120, 180 and 240.
10984695|NCT00979875|BG000|Baseline|Overall Study|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout.~Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart.~Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart.~Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart."
10984696|NCT00979875|FG000|Participant Flow|Lispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20."
10984697|NCT00979875|FG001|Participant Flow|Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, Aspart|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone."
10984698|NCT00979875|FG002|Participant Flow|Lispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20."
10984699|NCT00979875|FG003|Participant Flow|Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, Lispro|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.~After a 3- to 14-day washout, participants received a single, subcutaneous (SC) injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone."
11007226|NCT01089751|BG002|Baseline|Total|Total of all reporting groups
10984700|NCT00979875|FG004|Participant Flow|Aspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received and a single, SC injection of 95 U/mL Glulisine alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20."
10984701|NCT00979875|FG005|Participant Flow|Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone."
10984702|NCT00979875|OG000|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
10984703|NCT00979875|OG001|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
10984704|NCT00979875|OG002|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
10984705|NCT00979875|OG003|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
10984706|NCT00979875|OG004|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
10984707|NCT00979875|OG005|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
10984708|NCT00979875|EG000|Reported Event|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
10984709|NCT00979875|EG001|Reported Event|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
10984710|NCT00979875|EG002|Reported Event|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
10984711|NCT00979875|EG003|Reported Event|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
10984712|NCT00979875|EG004|Reported Event|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
10984713|NCT00979875|EG005|Reported Event|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
10984714|NCT00979940|BG000|Baseline|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
10984715|NCT00979940|BG001|Baseline|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
10984716|NCT00979940|BG002|Baseline|Total|Total of all reporting groups
10984717|NCT00979940|FG000|Participant Flow|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
10846393|NCT00275509|FG000|Participant Flow|Thymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6.
10984718|NCT00979940|FG001|Participant Flow|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
10984719|NCT00979940|OG000|Outcome|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
10984720|NCT00979940|OG001|Outcome|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
10984721|NCT00979940|EG000|Reported Event|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
10984722|NCT00979940|EG001|Reported Event|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
10984723|NCT00979953|BG000|Baseline|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
10984724|NCT00979953|BG001|Baseline|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
10984725|NCT00979953|BG002|Baseline|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
10984726|NCT00979953|BG003|Baseline|Placebo|Four placebo capsules administered orally BID for 14 days
10984727|NCT00979953|BG004|Baseline|Total|Total of all reporting groups
10984728|NCT00979953|FG000|Participant Flow|ADL5859|One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days
10984729|NCT00979953|FG001|Participant Flow|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
10984730|NCT00979953|FG002|Participant Flow|Oxycodone CR|One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
10984731|NCT00979953|FG003|Participant Flow|Placebo|Four placebo capsules administered orally BID for 14 days
10984732|NCT00979953|OG000|Outcome|Placebo|Four placebo capsules administered orally BID for 14 days
11007227|NCT01089751|FG000|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
10984733|NCT00979953|OG001|Outcome|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID for Days 5 through 14"
10984734|NCT00979953|OG002|Outcome|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
10984735|NCT00979953|OG003|Outcome|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
10984736|NCT00979953|EG000|Reported Event|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
10984737|NCT00979953|EG001|Reported Event|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
10984738|NCT00979953|EG002|Reported Event|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
10984739|NCT00979953|EG003|Reported Event|Placebo|Four placebo capsules administered orally BID for 14 days
10984740|NCT00979992|BG000|Baseline|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
10984741|NCT00979992|FG000|Participant Flow|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
10984742|NCT00979992|OG000|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
10984743|NCT00979992|EG000|Reported Event|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
10984744|NCT00980005|BG000|Baseline|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
10984745|NCT00980005|BG001|Baseline|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
10984746|NCT00980005|BG002|Baseline|Total|Total of all reporting groups
10984747|NCT00980005|FG000|Participant Flow|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
10984748|NCT00980005|FG001|Participant Flow|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
10984749|NCT00980005|OG000|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
10984750|NCT00980005|OG001|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
10984751|NCT00980005|OG002|Outcome|Flulaval Less Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
10984752|NCT00980005|OG003|Outcome|Fluzone Les Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
10984753|NCT00980005|OG002|Outcome|Flulaval 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
10984754|NCT00980005|OG003|Outcome|Fluzone 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
10984755|NCT00980005|EG000|Reported Event|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
10984756|NCT00980005|EG001|Reported Event|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
10984757|NCT00980018|BG000|Baseline|Nilotinib|Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
10984758|NCT00980018|FG000|Participant Flow|Nilotinib|Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
10984759|NCT00980018|OG000|Outcome|Nilotinib|Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
10984760|NCT00980018|EG000|Reported Event|Nilotinib|Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
10984761|NCT00980044|BG000|Baseline|Tramadol 200 mg|Medication: Extended release tramadol for 1 week and then placebo given for 1 week
10984762|NCT00980044|BG001|Baseline|Placebo|Medication: Placebo given for two weeks
10984763|NCT00980044|BG002|Baseline|Tramadol 600 mg|Medication: Extended release tramadol 600 mg given for 1 week and then placebo given for 1 week
10984764|NCT00980044|BG003|Baseline|Total|Total of all reporting groups
10984765|NCT00980044|FG000|Participant Flow|Tramadol 200 mg Daily|Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week
10984766|NCT00980044|FG001|Participant Flow|Placebo|Placebo given for two weeks
10984767|NCT00980044|FG002|Participant Flow|Tramadol 600 mg Daily|Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing.
10984768|NCT00980044|OG000|Outcome|Tramadol 200 mg Daily|Medication: Extended release tramadol
10984769|NCT00980044|OG001|Outcome|Placebo|Medication
10984770|NCT00980044|OG002|Outcome|Tramadol 600 mg Daily|Medication: Extended release tramadol
10984771|NCT00980044|OG000|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
10984772|NCT00980044|OG001|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
10984773|NCT00980044|OG002|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
10984774|NCT00980044|EG000|Reported Event|Tramadol 200 mg|Medication: Extended release tramadol 200 mg daily for one week followed by placebo for one week
10984775|NCT00980044|EG001|Reported Event|Placebo|Medication: Placebo for 2 weeks
10984776|NCT00980044|EG002|Reported Event|Tramadol 600 mg|Medication: Extended release tramadol 600 mg daily for one week followed by placebo for one week
10984777|NCT00980057|BG000|Baseline|Adaptive CRT (aCRT) Pacing|"Cardiac resynchronization therapy (CRT) with adaptive pacing~Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)~Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status"
10984778|NCT00980057|BG001|Baseline|Standard Biventricular Pacing|"Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing)~Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)"
10984779|NCT00980057|BG002|Baseline|Total|Total of all reporting groups
10984780|NCT00980057|FG000|Participant Flow|Adaptive CRT (aCRT) Pacing|"Cardiac resynchronization therapy (CRT) with adaptive pacing~Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)~Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status"
10984781|NCT00980057|FG001|Participant Flow|Standard Biventricular Pacing|"Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing)~Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)"
10984782|NCT00980057|OG000|Outcome|Adaptive CRT (aCRT) Pacing|"Cardiac resynchronization therapy (CRT) with adaptive pacing~Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)~Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status"
10984783|NCT00980057|OG001|Outcome|Standard Biventricular Pacing|"Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing)~Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)"
10984784|NCT00980057|OG000|Outcome|All Randomized Patients|"The AoVTI was calculated for each Adaptive CRT subject under two different parameter settings: AV and VV settings determined by Adaptive CRT, and AV and VV settings determined by echo-optimization.~Subsequently a concordance correlation was calculated and reported, thus this measure cannot be reported per treatment arm."
10984785|NCT00980057|EG000|Reported Event|Adaptive CRT (aCRT) Pacing|"Cardiac resynchronization therapy (CRT) with adaptive pacing~Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)~Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status"
10984786|NCT00980057|EG001|Reported Event|Standard Biventricular Pacing|"Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing)~Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)"
10984787|NCT00980148|BG000|Baseline|Azithromycin Arm|Azithromycin 1 gm oral single dose
10984788|NCT00980148|BG001|Baseline|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
10984789|NCT00980148|BG002|Baseline|Total|Total of all reporting groups
10984790|NCT00980148|FG000|Participant Flow|Azithromycin Arm|Azithromycin 1 gm oral single dose
10984791|NCT00980148|FG001|Participant Flow|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
10984792|NCT00980148|OG000|Outcome|Azithromycin Arm|Azithromycin 1 gm oral single dose
10984793|NCT00980148|OG001|Outcome|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
10984794|NCT00980148|EG000|Reported Event|Azithromycin Arm|Azithromycin 1 gm oral single dose
10984795|NCT00980148|EG001|Reported Event|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
10984796|NCT00980174|BG000|Baseline|Placebo|
10984797|NCT00980174|BG001|Baseline|Denosumab 60 mg Q6M|
10984798|NCT00980174|BG002|Baseline|Total|Total of all reporting groups
10984799|NCT00980174|FG000|Participant Flow|Placebo|
10984800|NCT00980174|FG001|Participant Flow|Denosumab 60 mg Q6M|
10984801|NCT00980174|OG000|Outcome|Placebo|
10984802|NCT00980174|OG001|Outcome|Denosumab 60 mg Q6M|
10984803|NCT00980174|EG000|Reported Event|Placebo|
10984804|NCT00980174|EG001|Reported Event|Denosumab 60 mg Q6M|
10984805|NCT00980200|BG000|Baseline|PB, GW642444 6.25 µg QD, 6.25 µg BID, 12.5 µg QD, and 25 µg QD|All participants received one of the following five treatments in one of the five Treatment Periods from two DPI dispensed on Day 1of each of the five 7-day treatment periods: Placebo (PB), GW642444 6.25 µg once daily (QD) in the evening, GW642444 6.25 µg twice daily (BID), GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening. Participants received their first evening medication dose in the clinic on Day 1 of each of the five treatment periods. The treatments were administered in the morning (AM) and in the evening (PM), approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a 7-day washout period.
10984806|NCT00980200|FG000|Participant Flow|Sequence 1: 6.25 µg BID, Pbo, 12.5 µg QD, 25 µg QD, 6.25 µg QD|Participants received GW642444 6.25 micrograms (µg) twice a day (BID), placebo (pbo), GW642444 12.5 µg once a day (QD) in the evening, GW642444 25 µg QD in the evening, and GW642444 6.25 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a Dry Powder Inhaler (DPI) for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
10984807|NCT00980200|FG001|Participant Flow|Sequence 2: Pbo, 6.25 µg BID, 6.25 µg QD, 12.5 µg QD, 25 µg QD|Participants received placebo, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
10984808|NCT00980200|FG002|Participant Flow|Sequence 3: 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID, 12.5 µg QD|Participants received GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, GW642444 6.25 µg BID, and GW642444 12.5 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
10984809|NCT00980200|FG003|Participant Flow|Sequence 4: 12.5 µg QD, 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID|Participants received GW642444 12.5 µg QD in the evening, GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, and GW642444 6.25 µg BID and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
10984810|NCT00980200|FG004|Participant Flow|Sequence 5: 25 µg QD, 12.5 µg QD, 6.25 µg BID, 6.25 µg QD, Pbo|Participants received GW642444 25 µg QD in the evening, GW642444 12.5 µg QD in the evening, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, and placebo in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
10984811|NCT00980200|OG000|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
10984812|NCT00980200|OG001|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
10984813|NCT00980200|OG002|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
10984814|NCT00980200|OG003|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
10984815|NCT00980200|OG004|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
10984816|NCT00980200|EG000|Reported Event|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
11007228|NCT01089751|FG001|Participant Flow|Placebo|Placebo once daily on an empty stomach for 14 weeks.
11007229|NCT01089751|OG000|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
10984817|NCT00980200|EG001|Reported Event|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
10984818|NCT00980200|EG002|Reported Event|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
10984819|NCT00980200|EG003|Reported Event|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
10984820|NCT00980200|EG004|Reported Event|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
10984821|NCT00980278|BG000|Baseline|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
10984822|NCT00980278|BG001|Baseline|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
10984823|NCT00980278|BG002|Baseline|Total|Total of all reporting groups
10984824|NCT00980278|FG000|Participant Flow|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
10984825|NCT00980278|FG001|Participant Flow|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
10846394|NCT00275509|FG001|Participant Flow|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
10984826|NCT00980278|OG000|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
10984827|NCT00980278|OG001|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
10984828|NCT00980278|EG000|Reported Event|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
11007230|NCT01089751|OG001|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
10846395|NCT00275509|OG000|Outcome|Tymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
10984829|NCT00980278|EG001|Reported Event|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
10984830|NCT00980330|BG000|Baseline|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
10984831|NCT00980330|BG001|Baseline|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
10984832|NCT00980330|BG002|Baseline|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984833|NCT00980330|BG003|Baseline|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
10984834|NCT00980330|BG004|Baseline|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
10984835|NCT00980330|BG005|Baseline|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984836|NCT00980330|BG006|Baseline|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984837|NCT00980330|BG007|Baseline|Total|Total of all reporting groups
10984838|NCT00980330|FG000|Participant Flow|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
10984839|NCT00980330|FG001|Participant Flow|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
10984840|NCT00980330|FG002|Participant Flow|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984841|NCT00980330|FG003|Participant Flow|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
10984842|NCT00980330|FG004|Participant Flow|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
10984843|NCT00980330|FG005|Participant Flow|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984844|NCT00980330|FG006|Participant Flow|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984845|NCT00980330|OG000|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
10984846|NCT00980330|OG001|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
10984847|NCT00980330|OG002|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984848|NCT00980330|OG003|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
10984849|NCT00980330|OG004|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
10984850|NCT00980330|OG005|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984851|NCT00980330|OG006|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984852|NCT00980330|OG006|Outcome|All TMC435|Participants in all 6 TMC435 treatment groups combined.
10984853|NCT00980330|EG000|Reported Event|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
10984854|NCT00980330|EG001|Reported Event|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
10984855|NCT00980330|EG002|Reported Event|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984856|NCT00980330|EG003|Reported Event|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
10984857|NCT00980330|EG004|Reported Event|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
10984858|NCT00980330|EG005|Reported Event|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984859|NCT00980330|EG006|Reported Event|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
10984860|NCT00980343|BG000|Baseline|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
10984861|NCT00980343|BG001|Baseline|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
10984862|NCT00980343|BG002|Baseline|Total|Total of all reporting groups
10984863|NCT00980343|FG000|Participant Flow|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
10984864|NCT00980343|FG001|Participant Flow|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
10984865|NCT00980343|OG000|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
10984866|NCT00980343|OG001|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
10984867|NCT00980343|OG000|Outcome|Arm 1(Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.~Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
10984868|NCT00980343|EG000|Reported Event|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
10984869|NCT00980343|EG001|Reported Event|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
10984870|NCT00980395|BG000|Baseline|VCR (Velcade, Cladribine and Rituximab)|"Rituximab 375 mg/m2 IV day1~Cladribine 4 mg/m2 IV over 2 hours days 1-5~Bortezomib 1.3 mg/m2 IV days 1 and 4~Repeat every 28 days for a maximum of 6 cycles~rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.~bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.~cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles."
10984871|NCT00980395|FG000|Participant Flow|VCR (Velcade, Cladribine and Rituximab)|"Rituximab 375 mg/m2 IV day1~Cladribine 4 mg/m2 IV over 2 hours days 1-5~Bortezomib 1.3 mg/m2 IV days 1 and 4~Repeat every 28 days for a maximum of 6 cycles~rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.~bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.~cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles."
10984872|NCT00980395|OG000|Outcome|VCR (Velcade, Cladribine and Rituximab)|"Rituximab 375 mg/m2 IV day1~Cladribine 4 mg/m2 IV over 2 hours days 1-5~Bortezomib 1.3 mg/m2 IV days 1 and 4~Repeat every 28 days for a maximum of 6 cycles~rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.~bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.~cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles."
10984873|NCT00980395|EG000|Reported Event|VCR (Velcade, Cladribine and Rituximab)|"Rituximab 375 mg/m2 IV day1~Cladribine 4 mg/m2 IV over 2 hours days 1-5~Bortezomib 1.3 mg/m2 IV days 1 and 4~Repeat every 28 days for a maximum of 6 cycles~rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.~bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.~cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles."
10984874|NCT00980590|BG000|Baseline|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
10984875|NCT00980590|BG001|Baseline|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
10984876|NCT00980590|BG002|Baseline|Total|Total of all reporting groups
10984877|NCT00980590|FG000|Participant Flow|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
10984878|NCT00980590|FG001|Participant Flow|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
10984879|NCT00980590|OG000|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
10984880|NCT00980590|OG001|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
10984881|NCT00980590|EG000|Reported Event|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
10984882|NCT00980590|EG001|Reported Event|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
10846396|NCT00275509|OG001|Outcome|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
10846397|NCT00275509|EG000|Reported Event|Tymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
10984883|NCT00980642|BG000|Baseline|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
10984884|NCT00980642|BG001|Baseline|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
10984885|NCT00980642|BG002|Baseline|Total|Total of all reporting groups
10984886|NCT00980642|FG000|Participant Flow|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
10984887|NCT00980642|FG001|Participant Flow|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
10984888|NCT00980642|OG000|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery
10984889|NCT00980642|OG001|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
10984890|NCT00980642|OG000|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
10984891|NCT00980642|EG000|Reported Event|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
10984892|NCT00980642|EG001|Reported Event|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
10984893|NCT00980655|BG000|Baseline|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
10984894|NCT00980655|BG001|Baseline|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
10984895|NCT00980655|BG002|Baseline|Total|Total of all reporting groups
10984896|NCT00980655|FG000|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
10984897|NCT00980655|FG001|Participant Flow|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
10984898|NCT00980655|OG000|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
10984899|NCT00980655|OG000|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
10984900|NCT00980655|OG001|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
10984901|NCT00980655|OG002|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
10984902|NCT00980655|EG000|Reported Event|13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw|All participants aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.
10984903|NCT00980655|EG001|Reported Event|13vPnC Dose 3 Blood Draw to 13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.
10984904|NCT00980655|EG002|Reported Event|13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.
10984905|NCT00980655|EG003|Reported Event|23vPS Dose|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.
10984906|NCT00980655|EG004|Reported Event|Follow-up|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.
10984907|NCT00980681|BG000|Baseline|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
10984908|NCT00980681|FG000|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
10984909|NCT00980681|OG000|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after administration with Dotarem
10984910|NCT00980681|OG001|Outcome|Time-Of-Flight MRA|Patients benefiting from an MRA with no injection of contrast medium
10984911|NCT00980681|EG000|Reported Event|Dotarem|"Each subject will receive one injection of Dotarem 0.2ml/kg.~Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg"
10984912|NCT00980681|EG001|Reported Event|Time Of Flight|"Each subject will undergo a TOF Magnetic Resonance Angiography~Time of Flight: Each subject will undergo a TOF MRA"
10984913|NCT00980746|BG000|Baseline|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984914|NCT00980746|BG001|Baseline|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984915|NCT00980746|BG002|Baseline|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984916|NCT00980746|BG003|Baseline|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984917|NCT00980746|BG004|Baseline|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984918|NCT00980746|BG005|Baseline|Placebo|"Placebo~Placebo : oral route"
10984919|NCT00980746|BG006|Baseline|Total|Total of all reporting groups
10984920|NCT00980746|FG000|Participant Flow|ESL 1200 mg QD|Eslicarbazepine acetate (ESL) 1200 mg once daily. ESL tablets, scored to allow dose titration during the titration period.
10984921|NCT00980746|FG001|Participant Flow|ESL 400 mg BD|"ESL 400 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
10984922|NCT00980746|FG002|Participant Flow|ESL 600 mg BID|"ESL 600 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
10984923|NCT00980746|FG003|Participant Flow|ESL 800 mg BID|"ESL 800 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
10984924|NCT00980746|FG004|Participant Flow|ESL 800 mg QD|"ESL 800 mg once-daily~ESL tablets, scored to allow dose titration during the titration period."
10984925|NCT00980746|FG005|Participant Flow|Placebo|"Placebo~Placebo : oral route"
10984926|NCT00980746|OG000|Outcome|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984927|NCT00980746|OG001|Outcome|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984928|NCT00980746|OG002|Outcome|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984929|NCT00980746|OG003|Outcome|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984930|NCT00980746|OG004|Outcome|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984931|NCT00980746|OG005|Outcome|Placebo|"Placebo~Placebo : oral route"
10984932|NCT00980746|EG000|Reported Event|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984933|NCT00980746|EG001|Reported Event|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984934|NCT00980746|EG002|Reported Event|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984935|NCT00980746|EG003|Reported Event|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984936|NCT00980746|EG004|Reported Event|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
10984937|NCT00980746|EG005|Reported Event|Placebo|"Placebo~Placebo : oral route"
10984938|NCT00980785|BG000|Baseline|Placebo|"Matching Placebo~Placebo: Matching Placebo"
10984939|NCT00980785|BG001|Baseline|Active|"Ramipril 5mg/day~Ramipril: Ramipril 5 mg/day"
10984940|NCT00980785|BG002|Baseline|Total|Total of all reporting groups
10984941|NCT00980785|FG000|Participant Flow|Placebo|"Matching Placebo~Placebo: Matching Placebo"
10984942|NCT00980785|FG001|Participant Flow|Active|"Ramipril 5mg/day~Ramipril: Ramipril 5 mg/day"
10984943|NCT00980785|OG000|Outcome|Placebo|"Matching Placebo~Placebo: Matching Placebo"
10984944|NCT00980785|OG001|Outcome|Active|"Ramipril 5mg/day~Ramipril: Ramipril 5 mg/day"
10984945|NCT00980785|EG000|Reported Event|Placebo|"Matching Placebo~Placebo: Matching Placebo"
10984946|NCT00980785|EG001|Reported Event|Active|"Ramipril 5mg/day~Ramipril: Ramipril 5 mg/day"
10984947|NCT00980798|BG000|Baseline|Placebo|Placebo daily for 16 weeks
10984948|NCT00980798|BG001|Baseline|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
10984949|NCT00980798|BG002|Baseline|Total|Total of all reporting groups
10984950|NCT00980798|FG000|Participant Flow|Placebo|Placebo daily for 16 weeks
10984951|NCT00980798|FG001|Participant Flow|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
10984952|NCT00980798|OG000|Outcome|Placebo|Placebo daily for 16 weeks
10984953|NCT00980798|OG001|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
10984954|NCT00980798|EG000|Reported Event|Placebo|Placebo daily for 16 weeks
10984955|NCT00980798|EG001|Reported Event|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
10984956|NCT00980980|BG000|Baseline|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
10984957|NCT00980980|BG001|Baseline|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984958|NCT00980980|BG002|Baseline|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984959|NCT00980980|BG003|Baseline|Total|Total of all reporting groups
10984960|NCT00980980|FG000|Participant Flow|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
10984961|NCT00980980|FG001|Participant Flow|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984962|NCT00980980|FG002|Participant Flow|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984963|NCT00980980|OG000|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
10984964|NCT00980980|OG001|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984965|NCT00980980|OG002|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984966|NCT00980980|OG002|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984967|NCT00980980|OG001|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984968|NCT00980980|OG002|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984969|NCT00980980|EG000|Reported Event|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs Contact Precautions for MRSA+
10984970|NCT00980980|EG001|Reported Event|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984971|NCT00980980|EG002|Reported Event|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
10984972|NCT00981019|BG000|Baseline|Mortality*Incidence*5-year Survival*Early Detection Rate|The study-conducted as an online survey study-investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
10984973|NCT00981019|FG000|Participant Flow|Mortality*Incidence*5-year Survival*Early Detection Rate|The study-conducted as an online survey study-investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
10984974|NCT00981019|OG000|Outcome|Mortality*Incidence*5-year Survival*Early Detection Rate|"The survey introduced four different cancer statistics in scenarios about 2 different screening tests. To mask the fact that all statistics stemmed from prostate cancer screening, screening in the scenarios were labeled X and Z. The survey then introduced test Z, whose effectiveness was described in terms of a reduction of cancer mortality. After responding to the series of outcome questions about test Z, physicians received additional information on the cancer incidence, again followed by the outcome questions. In the next scenario, the survey introduced test X, whose effectiveness was described in terms of an increase in 5-year survival and, in the next step, with additional information on early detection rates. After each step, doctors had to respond to the same outcome questions as they had for test Z. Please not, information on test X and test Z were randomly presented to control for order effects."
10984975|NCT00981019|EG000|Reported Event|Mortality*Incidence*5-year Survival*Early Detection Rate|The study-conducted as an online survey study-investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
10984976|NCT00981045|BG000|Baseline|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
10984977|NCT00981045|BG001|Baseline|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
10984978|NCT00981045|BG002|Baseline|Total|Total of all reporting groups
10984979|NCT00981045|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
10984980|NCT00981045|FG001|Participant Flow|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
10984981|NCT00981045|OG000|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
10984982|NCT00981045|OG001|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
10984983|NCT00981045|EG000|Reported Event|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
10984984|NCT00981045|EG001|Reported Event|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
10984985|NCT00981084|BG000|Baseline|Armodafinil Then Placebo|"All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design~armodafinil : Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions."
10984986|NCT00981084|BG001|Baseline|Placebo Then Armodafinil|
10984987|NCT00981084|BG002|Baseline|Total|Total of all reporting groups
10984988|NCT00981084|FG000|Participant Flow|Armodafinil First and Placebo Second|Patients randomly assigned to this condition received a 250 mg dose of armodafinil in the first treatment period. There was then a one week washout period. They received a placebo in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
10984989|NCT00981084|FG001|Participant Flow|Placebo First and Armodafinil Second|Patients randomly assigned to this condition received a placebo in the first treatment period. There was then a one week washout period. They then received 250 mg armodafinil in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
10984990|NCT00981084|OG000|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
11007231|NCT01089751|EG000|Reported Event|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
10984991|NCT00981084|OG001|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
10984992|NCT00981084|EG000|Reported Event|Placebo Then Armodafinil (Placebo)|Adverse events reported after taking placebo in the Placebo then Armodafinil Group
10984993|NCT00981084|EG001|Reported Event|Armodafinil Then Placebo (Armodafinil)|Adverse events reported after taking armodafinil in the Armodafinil then placebo group
10984994|NCT00981084|EG002|Reported Event|Placebo Then Armodafinil (Armodafinil)|Adverse events following armodafinil in the placebo/armodafinil group
10984995|NCT00981084|EG003|Reported Event|Armodafinil Then Placebo (Placebo)|number of adverse events following placebo in the armodafniil then placebo condition.
10984996|NCT00981149|BG000|Baseline|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
10984997|NCT00981149|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
10984998|NCT00981149|BG002|Baseline|Total|Total of all reporting groups
10984999|NCT00981149|FG000|Participant Flow|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
10985000|NCT00981149|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
10985001|NCT00981149|OG000|Outcome|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
10985002|NCT00981149|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
10985003|NCT00981149|EG000|Reported Event|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
10985004|NCT00981149|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
10985005|NCT00981175|BG000|Baseline|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
10985006|NCT00981175|BG001|Baseline|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
10985007|NCT00981175|BG002|Baseline|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
10985008|NCT00981175|BG003|Baseline|Total|Total of all reporting groups
10985009|NCT00981175|FG000|Participant Flow|ChimeriVax™-JE Vaccine First, Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28.
10985010|NCT00981175|FG001|Participant Flow|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28.
10985011|NCT00981175|OG000|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
10985012|NCT00981175|OG001|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
10985013|NCT00981175|OG002|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
10985014|NCT00981175|OG000|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
10985015|NCT00981175|OG001|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent)at either Day 0 or Day 28
10985016|NCT00981175|OG002|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
10985017|NCT00981175|OG001|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent) at either Day 0 or Day 28
10985018|NCT00981175|OG002|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at month 6 following primary ChimeriVax™-JE and Diluent vaccination at Day 0 and Day 28
10985019|NCT00981175|EG000|Reported Event|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
10985020|NCT00981175|EG001|Reported Event|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
10985021|NCT00981175|EG002|Reported Event|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
10985022|NCT00981214|BG000|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
10985023|NCT00981214|FG000|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
10985024|NCT00981214|OG000|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
11007232|NCT01089751|EG001|Reported Event|Placebo|Placebo once daily on an empty stomach for 14 weeks.
10985025|NCT00981214|EG000|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in capsule was administered orally or sprinkled on food. When required, from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
10985026|NCT00981227|BG000|Baseline|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
10985027|NCT00981227|BG001|Baseline|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
10985028|NCT00981227|BG002|Baseline|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
10985029|NCT00981227|BG003|Baseline|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
10985030|NCT00981227|BG004|Baseline|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
10985031|NCT00981227|BG005|Baseline|Placebo|"placebo~Placebo : oral route"
10985032|NCT00981227|BG006|Baseline|Total|Total of all reporting groups
10985033|NCT00981227|FG000|Participant Flow|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
10985034|NCT00981227|FG001|Participant Flow|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
10985035|NCT00981227|FG002|Participant Flow|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
10985036|NCT00981227|FG003|Participant Flow|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
10985037|NCT00981227|FG004|Participant Flow|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
10985038|NCT00981227|FG005|Participant Flow|Placebo|"placebo~Placebo : oral route"
10985039|NCT00981227|OG000|Outcome|ESL 1200 mg Once Daily|total daily dose;oral route
10985040|NCT00981227|OG001|Outcome|ESL 400 mg Twice-daily|total daily dose;oral route
10985041|NCT00981227|OG002|Outcome|ESL 600 mg Twice Daily|total daily dose;oral route
10985042|NCT00981227|OG003|Outcome|ESL 800 mg Once-daily|total daily dose;oral route
10985043|NCT00981227|OG004|Outcome|ESL 800 mg Twice Daily|total daily dose;oral route
10985044|NCT00981227|OG005|Outcome|Placebo|total daily dose;oral route
10985045|NCT00981227|OG000|Outcome|Placebo|"placebo~Placebo : oral route"
10985046|NCT00981227|OG001|Outcome|ESL 1200 mg/Day|total daily dose;oral route
10985047|NCT00981227|OG002|Outcome|ESL 1600 mg/Day|total daily dose;oral route
10985048|NCT00981227|OG003|Outcome|ESL 800 mg/Day|total daily dose;oral route
10985049|NCT00981227|EG000|Reported Event|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
10985050|NCT00981227|EG001|Reported Event|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
10985051|NCT00981227|EG002|Reported Event|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
10985052|NCT00981227|EG003|Reported Event|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
10985053|NCT00981227|EG004|Reported Event|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
10985054|NCT00981227|EG005|Reported Event|Placebo|"placebo~Placebo : oral route"
10985055|NCT00981253|BG000|Baseline|SMT-enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
10985056|NCT00981253|BG001|Baseline|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
10985057|NCT00981253|BG002|Baseline|Total|Total of all reporting groups
10985058|NCT00981253|FG000|Participant Flow|SMT-Enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
10985059|NCT00981253|FG001|Participant Flow|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
10985060|NCT00981253|OG000|Outcome|SMT-enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
10985061|NCT00981253|OG001|Outcome|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
10985062|NCT00981253|OG000|Outcome|SMT-Enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
10985063|NCT00981253|EG000|Reported Event|SMT-enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
10985064|NCT00981253|EG001|Reported Event|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
10985065|NCT00981292|BG000|Baseline|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
10985066|NCT00981292|BG001|Baseline|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
10985067|NCT00981292|BG002|Baseline|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
10985068|NCT00981292|BG003|Baseline|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
10985069|NCT00981292|BG004|Baseline|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
10985070|NCT00981292|BG005|Baseline|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
10985071|NCT00981292|BG006|Baseline|Total|Total of all reporting groups
10985072|NCT00981292|FG000|Participant Flow|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
10985073|NCT00981292|FG001|Participant Flow|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
10985074|NCT00981292|FG002|Participant Flow|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
10985075|NCT00981292|FG003|Participant Flow|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
10985076|NCT00981292|FG004|Participant Flow|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
10985077|NCT00981292|FG005|Participant Flow|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
10985078|NCT00981292|OG000|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
10985079|NCT00981292|OG001|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
10985080|NCT00981292|OG002|Outcome|Placebo|All participants when consumed Placebo.
10985081|NCT00981292|OG000|Outcome|135mg|All participants when consumed 135mg EGCG.
10985082|NCT00981292|EG000|Reported Event|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
10985083|NCT00981292|EG001|Reported Event|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
10985084|NCT00981292|EG002|Reported Event|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
10985085|NCT00981292|EG003|Reported Event|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
10985086|NCT00981292|EG004|Reported Event|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
10985087|NCT00981292|EG005|Reported Event|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
10985088|NCT00981305|BG000|Baseline|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
10985089|NCT00981305|BG001|Baseline|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
10985090|NCT00981305|BG002|Baseline|Total|Total of all reporting groups
10985091|NCT00981305|FG000|Participant Flow|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
10985092|NCT00981305|FG001|Participant Flow|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
10985093|NCT00981305|OG000|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
10985094|NCT00981305|OG001|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
10985095|NCT00981305|EG000|Reported Event|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
10985096|NCT00981305|EG001|Reported Event|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
10985097|NCT00981409|BG000|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
10985098|NCT00981409|BG001|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
10985099|NCT00981409|BG002|Baseline|Total|Total of all reporting groups
10985100|NCT00981409|FG000|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
10985101|NCT00981409|FG001|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
10985102|NCT00981409|OG000|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
10985103|NCT00981409|OG001|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
10985104|NCT00981409|EG000|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
10985105|NCT00981409|EG001|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
10985106|NCT00981435|BG000|Baseline|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
10985107|NCT00981435|BG001|Baseline|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
10985108|NCT00981435|BG002|Baseline|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
10985109|NCT00981435|BG003|Baseline|Total|Total of all reporting groups
10985110|NCT00981435|FG000|Participant Flow|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
10985111|NCT00981435|FG001|Participant Flow|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
10985112|NCT00981435|FG002|Participant Flow|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
10985113|NCT00981435|OG000|Outcome|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
10985114|NCT00981435|OG001|Outcome|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
10985115|NCT00981435|OG002|Outcome|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
11336555|NCT03568500|OG002|Outcome|First Episode Psychosis|Participants had a confirmed clinical diagnosis of first episode psychosis using case note review. The duration of illness was defined as less than 3 years since presentation to the mental health team or first antipsychotic prescription. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the HCP.
10985116|NCT00981435|EG000|Reported Event|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
10985117|NCT00981435|EG001|Reported Event|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
10985118|NCT00981435|EG002|Reported Event|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
10985119|NCT00981461|BG000|Baseline|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner
10985120|NCT00981461|BG001|Baseline|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis.
10985121|NCT00981461|BG002|Baseline|Total|Total of all reporting groups
10985122|NCT00981461|FG000|Participant Flow|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
10985123|NCT00981461|FG001|Participant Flow|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
10985124|NCT00981461|OG000|Outcome|Control Device|This control device is inactive emitting white light
10985125|NCT00981461|OG001|Outcome|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
10985126|NCT00981461|EG000|Reported Event|Control Device|This control device is inactive emitting white light
10985127|NCT00981461|EG001|Reported Event|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
10985128|NCT00981474|BG000|Baseline|Usual Care Group|"Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.~Control group: Institutional standard of care."
10985129|NCT00981474|BG001|Baseline|Autoregulation Group|"Blood pressure management based on cerebral autoregulation data.~blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised"
10985130|NCT00981474|BG002|Baseline|Total|Total of all reporting groups
10985131|NCT00981474|FG000|Participant Flow|Usual Care Group (Control)|"Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.~Control group: Institutional standard of care."
10985132|NCT00981474|FG001|Participant Flow|Autoregulation Group|"Blood pressure management based on cerebral autoregulation data.~blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised"
10985133|NCT00981474|OG000|Outcome|Usual Care Group (Control)|"Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.~Control group: Institutional standard of care."
10985134|NCT00981474|OG001|Outcome|Autoregulation Group|"Blood pressure management based on cerebral autoregulation data.~blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised"
10985135|NCT00981474|OG000|Outcome|Control|"Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.~Control group: Institutional standard of care."
10985136|NCT00981474|OG001|Outcome|Intervention|"Blood pressure management based on cerebral autoregulation data.~blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised"
10985137|NCT00981474|EG000|Reported Event|Usual Care Group (Control)|"Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.~Control group: Institutional standard of care."
10985138|NCT00981474|EG001|Reported Event|Autoregulation Group|"Blood pressure management based on cerebral autoregulation data.~Blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised"
10985139|NCT00981526|BG000|Baseline|A: Telmisartan|Telmisartan 80mg/day
10985140|NCT00981526|BG001|Baseline|B: Placebo|Placebo Group
10985141|NCT00981526|BG002|Baseline|Total|Total of all reporting groups
10985142|NCT00981526|FG000|Participant Flow|A: Telmisartan|Telmisartan 80mg/day
10985143|NCT00981526|FG001|Participant Flow|B: Placebo|Placebo
10985144|NCT00981526|OG000|Outcome|A: Telmisartan|Telmisartan 80mg/day
10985145|NCT00981526|OG001|Outcome|B: Placebo|Placebo Group
10985146|NCT00981526|OG001|Outcome|B: Placebo|Placebo
10985147|NCT00981526|OG000|Outcome|A: Experimental|Telmisartan 80mg/day
10985148|NCT00981526|EG000|Reported Event|A: Experimental|Telmisartan 80mg/day
10985149|NCT00981526|EG001|Reported Event|B: Placebo|Placebo Group
10985150|NCT00981578|BG000|Baseline|ExAblate 2100 Treatment|"ExAblate 2100 ablation for the treatment of painful bone metastases.~ExAblate 2100: Conformal Bone System"
10985151|NCT00981578|FG000|Participant Flow|ExAblate 2100 Treatment|"ExAblate 2100 ablation for the treatment of painful bone metastases.~ExAblate 2100: Conformal Bone System"
10985152|NCT00981578|OG000|Outcome|ExAblate 2100 Treatment|"ExAblate 2100 ablation for the treatment of painful bone metastases.~ExAblate 2100: Conformal Bone System"
10985153|NCT00981578|EG000|Reported Event|ExAblate 2100 Treatment|"ExAblate 2100 ablation for the treatment of painful bone metastases.~ExAblate 2100: Conformal Bone System"
10985154|NCT00981630|BG000|Baseline|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
10985155|NCT00981630|BG001|Baseline|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
10985156|NCT00981630|BG002|Baseline|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
10985157|NCT00981630|BG003|Baseline|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
10985158|NCT00981630|BG004|Baseline|Total|Total of all reporting groups
10985159|NCT00981630|FG000|Participant Flow|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
10985160|NCT00981630|FG001|Participant Flow|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
10985161|NCT00981630|FG002|Participant Flow|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
10985162|NCT00981630|FG003|Participant Flow|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
10985163|NCT00981630|OG000|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
10985164|NCT00981630|OG001|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
10985165|NCT00981630|OG002|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
10985166|NCT00981630|OG003|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
10985167|NCT00981630|EG000|Reported Event|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
10985168|NCT00981630|EG001|Reported Event|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
10985169|NCT00981630|EG002|Reported Event|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
10985170|NCT00981630|EG003|Reported Event|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
10985171|NCT00981669|BG000|Baseline|Rotavirus Vaccine|3 doses with 6 weeks interval
10985172|NCT00981669|BG001|Baseline|Placebo|3 doses with 6 weeks interval
10985173|NCT00981669|BG002|Baseline|Total|Total of all reporting groups
10985174|NCT00981669|FG000|Participant Flow|Rotavirus Vaccine|3 doses with 6 weeks interval
10985175|NCT00981669|FG001|Participant Flow|Placebo|3 doses with 6 weeks interval
10985176|NCT00981669|OG000|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
10985177|NCT00981669|OG001|Outcome|Placebo|3 doses with 6 weeks interval
10985178|NCT00981669|EG000|Reported Event|Rotavirus Vaccine|3 doses with 6 weeks interval
10985179|NCT00981669|EG001|Reported Event|Placebo|3 doses with 6 weeks interval
10985180|NCT00981682|BG000|Baseline|SER120 750 mcg|All participants received up to 750 mcg SER120 once daily
10985181|NCT00981682|FG000|Participant Flow|SER120 750 mcg|All participants received up to 750 mcg SER120 once daily
10985182|NCT00981682|OG000|Outcome|SER120 750 mcg|All participants received up to 750 mcg SER120 once daily
10985183|NCT00981682|EG000|Reported Event|SER120 750 mcg|All participants received up to 750 mcg SER120 once daily
10985184|NCT00981747|BG000|Baseline|All Study Participants|Study participants are patients that have been diagnosed with idiopathic pulmonary fibrosis (IPF).
10985185|NCT00981747|FG000|Participant Flow|All Study Participants|Participants will be randomized to take one of the study medications (Sildenafil, Losartan, placebo oral tablet, and Sildenafil and Losartan) at a time. Participants will be randomized to take these medications for 3 months with a washout period of one month before starting the next medication. The order or medications taken is random in order to blind the investigator and participant
10985186|NCT00981747|OG000|Outcome|Sildenafil|Sildenafil: Sildenafil 20mg three times per day for 3 months
10985187|NCT00981747|OG001|Outcome|Losartan|Losartan: Losartan 25mg two times a day for 3 months
10985188|NCT00981747|OG002|Outcome|Sildenafil and Losartan|Sildenafil and Losartan: Sildenafil 20mg three times per day and Losartan 25mg two times per day.
10985189|NCT00981747|OG003|Outcome|Placebo|Placebo pill: Placebo pill three times per day for 3 months
10985190|NCT00981747|EG000|Reported Event|Sildenafil|Sildenafil: Sildenafil 20mg three times per day for 3 months
10985191|NCT00981747|EG001|Reported Event|Losartan|Losartan: Losartan 25mg two times a day for 3 months
10985192|NCT00981747|EG002|Reported Event|Sildenafil and Losartan|Sildenafil and Losartan: Sildenafil 20mg three times per day and Losartan 25mg two times per day.
10985193|NCT00981747|EG003|Reported Event|Placebo|Placebo pill: Placebo pill three times per day for 3 months
10985194|NCT00981799|BG000|Baseline|Nelarabine Dose Level 1|"The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent MTD) and 330 mg/m2 Cyclophosphamide. The first 3 patients will be enrolled into Dose Level 1.~If 0/3 experiences dose limiting toxicity (DLT) at a given dose level, then the dose is escalated to the next higher level and 3 more patients are enrolled. If 1/3 experiences DLT at current dose, the up to 3 more patients are accrued at the same dose level. If 2 or more DLTs are observed in a 3-patient or 6-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to 3 additional patients will be enrolled at the next lower dose level (unless 6 patients have already been treated at that prior dose). If the MTD is exceeded at Dose Level 0, the study will be closed."
10985195|NCT00981799|BG001|Baseline|Nelarabine Dose Level 2|"Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.~This is the second dose level of this dose escalation study. If 1 or fewer patients at Dose Level 1 experiences a DLT, patients will be accrued at Dose Level 2.~If 0/3 experiences dose limiting toxicity (DLT) at a given dose level, then the dose is escalated to the next higher level and 3 more patients are enrolled. If 1/3 experiences DLT at current dose, the up to 3 more patients are accrued at the same dose level. If 2 or more DLTs are observed in a 3-patient or 6-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to 3 additional patients will be enrolled at the next lower dose level (unless 6 patients have already been treated at that prior dose). If the MTD is exceeded at Dose Level 0, the study will be closed."
10985196|NCT00981799|BG002|Baseline|Nelarabine Dose Level 3|"Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide This is the third and final dose level of this dose escalation study. If 1 or fewer patients at Dose Level 2 experiences a DLT, patients will be accrued at Dose Level 3.~If 0/3 experiences dose limiting toxicity (DLT) at a given dose level, then the dose is escalated to the next higher level and 3 more patients are enrolled. If 1/3 experiences DLT at current dose, the up to 3 more patients are accrued at the same dose level. If 2 or more DLTs are observed in a 3-patient or 6-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to 3 additional patients will be enrolled at the next lower dose level (unless 6 patients have already been treated at that prior dose). If the MTD is exceeded at Dose Level 0, the study will be closed."
10985197|NCT00981799|BG003|Baseline|Nelarabine Dose Level 0|Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
10985198|NCT00981799|BG004|Baseline|Total|Total of all reporting groups
10985199|NCT00981799|FG000|Participant Flow|Nelarabine Dose Level 1|"The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded.~Nelarabine: Dose will be assigned at study entry. Nelarabine will be given IV over"
10985200|NCT00981799|FG001|Participant Flow|Nelarabine Dose Level 2|Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
10985201|NCT00981799|FG002|Participant Flow|Nelarabine Dose Level 3|Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
10985202|NCT00981799|FG003|Participant Flow|Nelarabine Dose Level 0|"Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.~Nelarabine: Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.~Etoposide: 100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5~Cyclophosphamide: Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.~Methotrexate: Give between day 29 and 36 or when ANC>750 and PLTS>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation.~Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but <2 years of age 10 mg for patients age greater than"
10985203|NCT00981799|OG000|Outcome|Nelarabine Dose Level 1|The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded.
10985204|NCT00981799|OG001|Outcome|Nelarabine Dose Level 2|Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
10985205|NCT00981799|OG002|Outcome|Nelarabine Dose Level 3|Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
10985206|NCT00981799|OG003|Outcome|Nelarabine Dose Level 0|Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
10985207|NCT00981799|OG003|Outcome|Nelarabine Dose Level 0|"Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.~Nelarabine: Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.~Etoposide: 100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5~Cyclophosphamide: Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.~Methotrexate: Give between day 29 and 36 or when ANC>750 and PLTS>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation.~Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but <2 years of age 10 mg for patients age greater than"
10985208|NCT00981799|EG000|Reported Event|Nelarabine Dose Level 1|The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded. The first 3 patients will be enrolled into Dose Level 1.
10985209|NCT00981799|EG001|Reported Event|Nelarabine Dose Level 2|Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
10985210|NCT00981799|EG002|Reported Event|Nelarabine Dose Level 3|Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
10985211|NCT00981799|EG003|Reported Event|Nelarabine Dose Level 0|Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
10985212|NCT00981812|BG000|Baseline|Primary|Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy.
10985213|NCT00981812|FG000|Participant Flow|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
10985214|NCT00981812|OG000|Outcome|Lesions Visualized Using Positron Emission Mammography (PEM)|Total lesions visualized using positron emission mammography.
10985215|NCT00981812|EG000|Reported Event|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
10985216|NCT00981825|BG000|Baseline|Fluoride 1st, Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)
10985217|NCT00981825|BG001|Baseline|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)
10985218|NCT00981825|BG002|Baseline|Total|Total of all reporting groups
10985219|NCT00981825|FG000|Participant Flow|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
10985220|NCT00981825|FG001|Participant Flow|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
10985221|NCT00981825|OG000|Outcome|Fluoride Toothpaste (Control)|Fluoride toothpaste (control)
10985222|NCT00981825|OG001|Outcome|Triclosan/Fluoride Toothpaste|Triclosan/Fluoride toothpaste (experimental)
10985223|NCT00981825|EG000|Reported Event|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
10985224|NCT00981825|EG001|Reported Event|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
10985225|NCT00982007|BG000|Baseline|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
10985226|NCT00982007|BG001|Baseline|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
10985227|NCT00982007|BG002|Baseline|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
10985228|NCT00982007|BG003|Baseline|Cohort 2 (Group D) - IV Iron (Standard of Care)|Other IV iron IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
10985229|NCT00982007|BG004|Baseline|Total|Total of all reporting groups
10985230|NCT00982007|FG000|Participant Flow|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
10985231|NCT00982007|FG001|Participant Flow|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
10985232|NCT00982007|FG002|Participant Flow|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
10985233|NCT00982007|FG003|Participant Flow|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
10985234|NCT00982007|OG000|Outcome|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
10985235|NCT00982007|OG001|Outcome|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
10985236|NCT00982007|OG002|Outcome|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
10985237|NCT00982007|OG003|Outcome|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
10985238|NCT00982007|EG000|Reported Event|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
10985239|NCT00982007|EG001|Reported Event|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
10985240|NCT00982007|EG002|Reported Event|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
10985241|NCT00982007|EG003|Reported Event|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
10985242|NCT00982020|BG000|Baseline|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
10985243|NCT00982020|BG001|Baseline|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
10985244|NCT00982020|BG002|Baseline|Total|Total of all reporting groups
10985245|NCT00982020|FG000|Participant Flow|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
10985246|NCT00982020|FG001|Participant Flow|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
10985247|NCT00982020|OG000|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
10985248|NCT00982020|OG001|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
10985249|NCT00982020|OG000|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
10985250|NCT00982020|OG001|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
10985251|NCT00982020|OG001|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
10985252|NCT00982020|OG000|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
10985253|NCT00982020|OG001|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
10985254|NCT00982020|EG000|Reported Event|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
10985255|NCT00982020|EG001|Reported Event|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
10985256|NCT00982033|BG000|Baseline|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
10985257|NCT00982033|BG001|Baseline|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
10985258|NCT00982033|BG002|Baseline|Total|Total of all reporting groups
10985259|NCT00982033|FG000|Participant Flow|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.~aliskiren: aliskiren 300mg qd versus placebo for 24 weeks."
10985260|NCT00982033|FG001|Participant Flow|Placebo|"50% of subjects will be randomized to placebo.~placebo: placebo qd for 24 weeks"
10985261|NCT00982033|OG000|Outcome|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
10985262|NCT00982033|OG001|Outcome|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
10985263|NCT00982033|EG000|Reported Event|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
10985264|NCT00982033|EG001|Reported Event|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
10985265|NCT00982072|BG000|Baseline|Prednisolone|"prednisolone tablets~prednisolone: Prednisolone 1mg/kg maximum 60mg od"
10985266|NCT00982072|BG001|Baseline|Tacrolimus|"tacrolimus tablets~tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)"
10985267|NCT00982072|BG002|Baseline|Total|Total of all reporting groups
10985268|NCT00982072|FG000|Participant Flow|Prednisolone|"prednisolone tablets~prednisolone: Prednisolone 1mg/kg maximum 60mg od"
10985269|NCT00982072|FG001|Participant Flow|Tacrolimus|"tacrolimus tablets~tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)"
10985270|NCT00982072|OG000|Outcome|Prednisolone|"prednisolone tablets~prednisolone: Prednisolone 1mg/kg maximum 60mg od"
10985271|NCT00982072|OG001|Outcome|Tacrolimus|"tacrolimus tablets~tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)"
10985272|NCT00982072|EG000|Reported Event|Prednisolone|"prednisolone tablets~prednisolone: Prednisolone 1mg/kg maximum 60mg od"
10985273|NCT00982072|EG001|Reported Event|Tacrolimus|"tacrolimus tablets~tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)"
10985274|NCT00982137|BG000|Baseline|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
10985275|NCT00982137|BG001|Baseline|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
10985276|NCT00982137|BG002|Baseline|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
10985277|NCT00982137|BG003|Baseline|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
10985278|NCT00982137|BG004|Baseline|Total|Total of all reporting groups
10985279|NCT00982137|FG000|Participant Flow|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
10985280|NCT00982137|FG001|Participant Flow|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
10985281|NCT00982137|FG002|Participant Flow|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
10985282|NCT00982137|FG003|Participant Flow|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
10985283|NCT00982137|OG000|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
10985284|NCT00982137|OG001|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
10985285|NCT00982137|OG002|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
10985286|NCT00982137|OG003|Outcome|Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL|Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
10985287|NCT00982137|OG002|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
10985288|NCT00982137|OG003|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
10985289|NCT00982137|OG000|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
10985290|NCT00982137|OG001|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
10985291|NCT00982137|OG002|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
10985292|NCT00982137|OG003|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
10985293|NCT00982137|OG001|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-JE on Day 30.
10985294|NCT00982137|EG000|Reported Event|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
10985295|NCT00982137|EG001|Reported Event|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
10985296|NCT00982137|EG002|Reported Event|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
10985297|NCT00982137|EG003|Reported Event|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
10985298|NCT00982189|BG000|Baseline|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
10985299|NCT00982189|BG001|Baseline|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
10985300|NCT00982189|BG002|Baseline|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
10985301|NCT00982189|BG003|Baseline|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
10985302|NCT00982189|BG004|Baseline|Total|Total of all reporting groups
10985303|NCT00982189|FG000|Participant Flow|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
10985304|NCT00982189|FG001|Participant Flow|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
10985305|NCT00982189|FG002|Participant Flow|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
10985306|NCT00982189|FG003|Participant Flow|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
10985307|NCT00982189|OG000|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
10985308|NCT00982189|OG001|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
11223188|NCT02351700|OG001|Outcome|Standard Treatment Group|"IV Caldolor placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.~IV Ibuprofen placebo: Compare addition of IV ibuprofen placebo intraoperatively and postoperatively against IV Caldolor (IV ibuprofen) added intraoperatively and postoperatively."
11223189|NCT02351700|OG000|Outcome|Opioid Sparing Group|IV Caldolor (ibuprofen) 800 mg every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed
11223190|NCT02351700|OG001|Outcome|Standard Treatment Group|IV placebo every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed
11336556|NCT03568500|EG000|Reported Event|Aripiprazole|Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks.
11336557|NCT03568500|EG001|Reported Event|Olanzapine|Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
10985309|NCT00982189|OG002|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
10985310|NCT00982189|OG003|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
10985311|NCT00982189|OG000|Outcome|Lisinopril/L-placebo Treatment Effect|Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
10985312|NCT00982189|OG000|Outcome|Pravastatin/P-placebo Treatment Effect|Pravastatin vs. Pravastatin-placebo (regardless of Lisinopril status)
10985313|NCT00982189|EG000|Reported Event|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
10985314|NCT00982189|EG001|Reported Event|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
10985315|NCT00982189|EG002|Reported Event|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
10985316|NCT00982189|EG003|Reported Event|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
10985317|NCT00982228|BG000|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
10985318|NCT00982228|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
10985319|NCT00982228|BG002|Baseline|Total|Total of all reporting groups
10985320|NCT00982228|FG000|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
10985321|NCT00982228|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
10985322|NCT00982228|OG000|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
10985323|NCT00982228|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
10985324|NCT00982228|EG000|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
10985325|NCT00982228|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
10985326|NCT00982280|BG000|Baseline|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985327|NCT00982280|FG000|Participant Flow|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985328|NCT00982280|OG000|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985329|NCT00982280|OG000|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985330|NCT00982280|EG000|Reported Event|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985331|NCT00982319|BG000|Baseline|Broccoli Sprout Extract and Mango Juice|"Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice compared to a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).~Broccoli sprout extract (sulforaphane): Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to either a prepartion of broccoli sprout extract and mango juice or a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study."
10985332|NCT00982319|BG001|Baseline|Mango Juice|"Patients will be randomized to 14 day intervention of Mango juice without broccoli extract. All women will be on a cruciferous free diet for the duration of the study (14 days).~Mango juice: Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to either a prepartion of broccoli sprout extract and mango juice or a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study."
10985333|NCT00982319|BG002|Baseline|Total|Total of all reporting groups
10985334|NCT00982319|FG000|Participant Flow|Broccoli Sprout Extract and Mango Juice|"Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice compared to a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).~Broccoli sprout extract (sulforaphane): Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to receive a prepartion of broccoli sprout extract and mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study."
10985335|NCT00982319|FG001|Participant Flow|Mango Juice|"Patients will be randomized to 14 day intervention of mango juice without broccoli sprout extract. All women will be on a cruciferous free diet for the duration of the study (14 days).Mango juice without extract: Mango juice without broccoli sprout extract.~B Mango juice: Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to receive a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study."
10985336|NCT00982319|OG000|Outcome|Broccoli Sprout Extract and Mango Juice|Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days).
10846398|NCT00275509|EG001|Reported Event|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
10846399|NCT00275561|BG000|Baseline|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
10985337|NCT00982319|OG001|Outcome|Mango Juice Without Extract|Patients will be randomized to 14 day intervention of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).
10985338|NCT00982319|EG000|Reported Event|Broccoli Sprout Extract and Mango Juice|"Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice compared to a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).~Broccoli sprout extract (sulforaphane): Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to either a prepartion of broccoli sprout extract and mango juice or a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study."
10985339|NCT00982319|EG001|Reported Event|Mango Juice|"Patients will be randomized to 14 day intervention of Mango juice without broccoli extract. All women will be on a cruciferous free diet for the duration of the study (14 days).~Mango juice: Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to either a prepartion of broccoli sprout extract and mango juice or a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study."
10985340|NCT00982345|BG000|Baseline|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
10985341|NCT00982345|FG000|Participant Flow|Seroquel XR|Seroquel XR (quetiapine) starting dose 50 mg and increased up to 400 mg as tolerated) treatment.
10985342|NCT00982345|OG000|Outcome|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
10985343|NCT00982345|EG000|Reported Event|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
10985344|NCT00982397|BG000|Baseline|DR-ICD/CRT-D|Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
10985345|NCT00982397|BG001|Baseline|VR-ICD|Patients implanted with a single-chamber ICD (VR-ICD).
10985346|NCT00982397|BG002|Baseline|Total|Total of all reporting groups
10985347|NCT00982397|FG000|Participant Flow|DR-ICD/CRT-D|Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
10985348|NCT00982397|FG001|Participant Flow|VR-ICD|Patients implanted with a single-chamber ICD (VR-ICD).
10985349|NCT00982397|OG000|Outcome|DR-ICD/CRT-D|Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
10985350|NCT00982397|OG001|Outcome|VR-ICD|Patients implanted with a single-chamber ICD (VR-ICD).
10985351|NCT00982397|OG000|Outcome|Phase I|Subjects enrolled in Phase I of the study (Protecta).
10985352|NCT00982397|OG000|Outcome|18/24 NID|Secondary prevention subjects in Phase II randomized to 18/24 NID. (18/24 NID indicates the number of intervals used to detect VF was programmed to 18 of 24 intervals).
10985353|NCT00982397|OG001|Outcome|30/40 NID|Secondary prevention subjects in Phase II randomized to 30/40 NID. (30/40 NID indicates the number of intervals used to detect VF was programmed to 30 of 40 intervals).
10985354|NCT00982397|EG000|Reported Event|DR-ICD/CRT-D|Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
10985355|NCT00982397|EG001|Reported Event|VR-ICD|Patients implanted with a single-chamber ICD (VR-ICD).
10985356|NCT00982410|BG000|Baseline|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
11336558|NCT03568500|EG002|Reported Event|Quetiapine|Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
10985357|NCT00982410|BG001|Baseline|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
10985358|NCT00982410|BG002|Baseline|Total|Total of all reporting groups
10985359|NCT00982410|FG000|Participant Flow|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor Veterans Affairs Medical Center (VAMC). Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
10985360|NCT00982410|FG001|Participant Flow|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
10985361|NCT00982410|OG000|Outcome|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
10985362|NCT00982410|OG001|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
10985363|NCT00982410|OG000|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
10985364|NCT00982410|EG000|Reported Event|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition's main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
10985365|NCT00982410|EG001|Reported Event|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition's provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
10985366|NCT00982423|BG000|Baseline|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
10985367|NCT00982423|BG001|Baseline|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
10985368|NCT00982423|BG002|Baseline|Total|Total of all reporting groups
10985369|NCT00982423|FG000|Participant Flow|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
10985370|NCT00982423|FG001|Participant Flow|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
10985371|NCT00982423|OG000|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
10985372|NCT00982423|OG001|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
10846400|NCT00275561|BG001|Baseline|Placebo|Placebo inhaler swallowed bid for 6 weeks
10985373|NCT00982423|OG000|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
10985374|NCT00982423|EG000|Reported Event|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
10985375|NCT00982423|EG001|Reported Event|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
10985376|NCT00982488|BG000|Baseline|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985377|NCT00982488|BG001|Baseline|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985378|NCT00982488|BG002|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985379|NCT00982488|BG003|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10846401|NCT00275561|BG002|Baseline|Total|Total of all reporting groups
10985380|NCT00982488|BG004|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985381|NCT00982488|BG005|Baseline|Total|Total of all reporting groups
10985382|NCT00982488|FG000|Participant Flow|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985383|NCT00982488|FG001|Participant Flow|Imatinib, 400 mg BID, Chronic Phase|Participants chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985384|NCT00982488|FG002|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985385|NCT00982488|FG003|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985386|NCT00982488|FG004|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985387|NCT00982488|OG000|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985388|NCT00982488|OG001|Outcome|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib twice daily (BID). Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985389|NCT00982488|OG002|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985390|NCT00982488|OG003|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985391|NCT00982488|OG004|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
11007233|NCT01090011|BG000|Baseline|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
10985392|NCT00982488|EG000|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985393|NCT00982488|EG001|Reported Event|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985394|NCT00982488|EG002|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985395|NCT00982488|EG003|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985396|NCT00982488|EG004|Reported Event|Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
10985397|NCT00982553|BG000|Baseline|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
10985398|NCT00982553|FG000|Participant Flow|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
10985399|NCT00982553|OG000|Outcome|Phase1_ribavirin|Single dose ribavirin 800mg administered on day 1
10985400|NCT00982553|OG001|Outcome|Phase3_ribovarin and Raltegravir|Single dose ribavirin 800mg and raltegravir 400mg at day 20
10985401|NCT00982553|OG000|Outcome|Phase2_Raltegravir|Raltegravir 400 mg twice daily on day 15-19
10985402|NCT00982553|OG001|Outcome|Phase3_ribovarin and Raltegravir|On day 20 single dose of both ribavirin and raltegravir administered together
10985403|NCT00982553|OG000|Outcome|Phase1_Ribavirin|Single dose ribavirin 800mg administered on day 1
10985404|NCT00982553|OG001|Outcome|Phase3_ribovarin and Raltegravir|Onn day 20 single dose of both ribavirin and raltegravir administered together
10985405|NCT00982553|EG000|Reported Event|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
10985406|NCT00982592|BG000|Baseline|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10985407|NCT00982592|BG001|Baseline|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10985408|NCT00982592|BG002|Baseline|Total|Total of all reporting groups
10985409|NCT00982592|FG000|Participant Flow|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10985410|NCT00982592|FG001|Participant Flow|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10985411|NCT00982592|OG000|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10985412|NCT00982592|OG001|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10985413|NCT00982592|EG000|Reported Event|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10985414|NCT00982592|EG001|Reported Event|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10985415|NCT00982644|BG000|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
10985416|NCT00982644|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
10985417|NCT00982644|BG002|Baseline|Total|Total of all reporting groups
10985418|NCT00982644|FG000|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
10985419|NCT00982644|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
10985420|NCT00982644|OG000|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
10985421|NCT00982644|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
10985422|NCT00982644|EG000|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
10985423|NCT00982644|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
10985424|NCT00982657|BG000|Baseline|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985425|NCT00982657|BG001|Baseline|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985426|NCT00982657|BG002|Baseline|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985427|NCT00982657|BG003|Baseline|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985428|NCT00982657|BG004|Baseline|Total|Total of all reporting groups
10985429|NCT00982657|FG000|Participant Flow|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985430|NCT00982657|FG001|Participant Flow|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985431|NCT00982657|FG002|Participant Flow|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985432|NCT00982657|FG003|Participant Flow|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985433|NCT00982657|OG000|Outcome|All Participants|All participants who received 6 mg/kg, 12mg/kg or 15 mg/kg of CVX-060 intravenous infusion along with oral 50 mg or 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985434|NCT00982657|OG000|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10846402|NCT00275561|FG000|Participant Flow|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
10985435|NCT00982657|OG001|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985436|NCT00982657|OG002|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985437|NCT00982657|OG003|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985438|NCT00982657|OG000|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985439|NCT00982657|OG001|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
10985440|NCT00982657|OG002|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
10985441|NCT00982657|OG003|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
10985442|NCT00982657|OG001|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent occurred or investigator's discretion.
10985443|NCT00982657|OG000|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985444|NCT00982657|OG001|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985445|NCT00982657|OG002|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985446|NCT00982657|OG003|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985447|NCT00982657|EG000|Reported Event|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985448|NCT00982657|EG001|Reported Event|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985449|NCT00982657|EG002|Reported Event|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985450|NCT00982657|EG003|Reported Event|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
10985451|NCT00982735|BG000|Baseline|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
10985452|NCT00982735|FG000|Participant Flow|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
10985453|NCT00982735|OG000|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
10985454|NCT00982735|EG000|Reported Event|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
10985455|NCT00982865|BG000|Baseline|MSC1936369B Regimen 1|Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
11336559|NCT03568500|EG003|Reported Event|Total|Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.
10846403|NCT00275561|FG001|Participant Flow|Placebo|Placebo inhaler swallowed bid for 6 weeks
10846404|NCT00275561|OG000|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
10985456|NCT00982865|BG001|Baseline|MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)|MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
10985457|NCT00982865|BG002|Baseline|MSC1936369B Regimen 3 Once Daily (QD)|Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985458|NCT00982865|BG003|Baseline|MSC1936369B Regimen 3 Twice Daily|Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985459|NCT00982865|BG004|Baseline|Total|Total of all reporting groups
10985460|NCT00982865|FG000|Participant Flow|MSC1936369B Regimen 1|Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985461|NCT00982865|FG001|Participant Flow|MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)|MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
10985462|NCT00982865|FG002|Participant Flow|MSC1936369B Regimen 3 Once Daily (QD)|Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985463|NCT00982865|FG003|Participant Flow|MSC1936369B Regimen 3 Twice Daily (BID)|Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985464|NCT00982865|OG000|Outcome|MSC1936369B Regimen 1|Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985465|NCT00982865|OG001|Outcome|MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)|MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
10985466|NCT00982865|OG002|Outcome|MSC1936369B Regimen 3 Once Daily (QD)|Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985467|NCT00982865|OG003|Outcome|MSC1936369B Regimen 3 Twice Daily|Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985468|NCT00982865|OG000|Outcome|MSC1936369B 1 mg|Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985469|NCT00982865|OG001|Outcome|MSC1936369B 1.5 mg|Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985470|NCT00982865|OG002|Outcome|MSC1936369B 2.5 mg|Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985471|NCT00982865|OG003|Outcome|MSC1936369B 3.5 mg|Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985472|NCT00982865|OG004|Outcome|MSC1936369B 7 mg|Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985473|NCT00982865|OG005|Outcome|MSC1936369B 14 mg|Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985474|NCT00982865|OG006|Outcome|MSC1936369B 28 mg|Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985475|NCT00982865|OG007|Outcome|MSC1936369B 45 mg|Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985476|NCT00982865|OG008|Outcome|MSC1936369B 68 mg|Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985477|NCT00982865|OG009|Outcome|MSC1936369B 94 mg|Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985478|NCT00982865|OG010|Outcome|MSC1936369B 120 mg|Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985479|NCT00982865|OG001|Outcome|MSC1936369B 2 mg|Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10846405|NCT00275561|OG001|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
10846406|NCT00275561|EG000|Reported Event|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
10985480|NCT00982865|OG002|Outcome|MSC1936369B 3.5 mg|Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision until PD or intolerable toxicity or investigator/subject decision.
10985481|NCT00982865|OG003|Outcome|MSC1936369B 5 mg|Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985482|NCT00982865|OG004|Outcome|MSC1936369B 7 mg|Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985483|NCT00982865|OG006|Outcome|MSC1936369B 28 mg|Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985484|NCT00982865|OG007|Outcome|MSC1936369B 45 mg|Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985485|NCT00982865|OG008|Outcome|MSC1936369B 68 mg|Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision until PD or intolerable toxicity or investigator/subject decision.
10985486|NCT00982865|OG009|Outcome|MSC1936369B 94 mg|Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985487|NCT00982865|OG010|Outcome|MSC1936369B 120 mg|Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985488|NCT00982865|OG011|Outcome|MSC1936369B 150 mg|Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
10985489|NCT00982865|OG012|Outcome|MSC1936369B 195 mg|Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985490|NCT00982865|OG013|Outcome|MSC1936369B 255 mg|Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985491|NCT00982865|OG000|Outcome|MSC1936369B 90 mg|Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
10985492|NCT00982865|OG001|Outcome|MSC1936369B 150 mg|Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
10985493|NCT00982865|OG000|Outcome|MSC1936369B 60 mg|Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985494|NCT00982865|OG001|Outcome|MSC1936369B 90 mg|Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
10985495|NCT00982865|OG000|Outcome|MSC1936369B 45 mg|Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985496|NCT00982865|OG001|Outcome|MSC1936369B 60 mg|Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985497|NCT00982865|OG002|Outcome|MSC1936369B 75 mg|Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985498|NCT00982865|OG002|Outcome|MSC1936369B 3.5 mg|Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985499|NCT00982865|OG008|Outcome|MSC1936369B 68 mg|Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10846407|NCT00275561|EG001|Reported Event|Placebo|Placebo inhaler swallowed bid for 6 weeks
10985500|NCT00982865|OG008|Outcome|MSC1936369B 68 mg|Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision until PD or intolerable toxicity or investigator/subject decision.
10985501|NCT00982865|OG009|Outcome|MSC1936369B 94 mg|Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision until PD or intolerable toxicity or investigator/subject decision.
10985502|NCT00982865|OG003|Outcome|MSC1936369B 3.5 mg|Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle.
10985503|NCT00982865|OG002|Outcome|MSC1936369B Regimen 3 Once Daily|Subjects received MSC1936369B capsules 60 or 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
11007234|NCT01090011|FG000|Participant Flow|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
10846408|NCT00275821|BG000|Baseline|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10985504|NCT00982865|OG001|Outcome|MSC1936369B Regimen 2 and Regimen 2 Food Effect|Combined data for both Regimen 2 with and without food effect was reported in this arm. MSC1936369B Regimen 2: Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (FE): Subjects received MSC1936369B capsules 90-150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Cycle 2 dosing.
10985505|NCT00982865|EG000|Reported Event|MSC1936369B Regimen 1|Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985506|NCT00982865|EG001|Reported Event|MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)|MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
10985507|NCT00982865|EG002|Reported Event|MSC1936369B Regimen 3 Once Daily (QD)|Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985508|NCT00982865|EG003|Reported Event|MSC1936369B Regimen 3 Twice Daily|Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
10985509|NCT00982878|BG000|Baseline|Maraviroc|Maraviroc: 150mg twice daily
10985510|NCT00982878|FG000|Participant Flow|Maraviroc|Maraviroc: 150mg twice daily
10985511|NCT00982878|OG000|Outcome|Maraviroc|Maraviroc: 150mg twice daily
10985512|NCT00982878|EG000|Reported Event|Maraviroc|Maraviroc: 150mg twice daily
10985513|NCT00982930|BG000|Baseline|Tobramycin Inhalation Powder|Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, b.i.d., given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.
10985514|NCT00982930|FG000|Participant Flow|Tobramycin Inhalation Powder (TIP)|Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, twice a day (b.i.d), given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.
10985515|NCT00982930|OG000|Outcome|Tobramycin Inhalation Powder|Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, b.i.d., given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.
10985516|NCT00982930|EG000|Reported Event|Tobramycin Inhalation Powder|Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, b.i.d., given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.
10985517|NCT00983073|BG000|Baseline|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985518|NCT00983073|FG000|Participant Flow|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985519|NCT00983073|OG000|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985520|NCT00983073|OG000|Outcome|Tapentadol PR|All participants started with either 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
11007235|NCT01090011|OG000|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
11336560|NCT03568539|BG000|Baseline|Cohort 1|Advanced/metastatic cancers with TMB>10 mutations per megabase (mut/Mb). 200mg IV Q3W.
10846409|NCT00275821|BG001|Baseline|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10985521|NCT00983073|EG000|Reported Event|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985522|NCT00983216|BG000|Baseline|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
10985523|NCT00983216|FG000|Participant Flow|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
10985524|NCT00983216|OG000|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
10985525|NCT00983216|OG001|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
10985526|NCT00983216|EG000|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
10985527|NCT00983216|EG001|Reported Event|Ketoconazole Alone|On Day 15 to 18, subjects took ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals.
11336561|NCT03568539|BG001|Baseline|Cohort 2|Advanced/metastatic endometrial cancer. 200mg IV Q3W.
10985528|NCT00983216|EG002|Reported Event|Colchicine With Ketoconazole (at Steady-state)|On the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
10985529|NCT00983242|BG000|Baseline|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
10985530|NCT00983242|FG000|Participant Flow|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
10985531|NCT00983242|OG000|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
10985532|NCT00983242|OG001|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
10985533|NCT00983242|EG000|Reported Event|Colchicine Alone|At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
10985534|NCT00983242|EG001|Reported Event|Verapamil HCl ER|At 8am on Days 15-18 all subjects received a dose of verapamil HCl ER 240 mg without regard to meals.
10985535|NCT00983242|EG002|Reported Event|Colchicine With Verapamil HCl ER|At 8am on Day 19 following a 10 hour fast all subjects received one dose of verapamil HCl ER 240 mg along with one dose of colchicine 0.6 mg.
10985536|NCT00983281|BG000|Baseline|Hextend|Patients that received Hextend as part of their resuscitation fluid.
10985537|NCT00983281|BG001|Baseline|Standard of Care|Patients that received standard of care but no Hextend as part of their resuscitation.
10985538|NCT00983281|BG002|Baseline|Total|Total of all reporting groups
10985539|NCT00983281|FG000|Participant Flow|Hextend|Patients that received Hextend as part of their resuscitation fluid.
10985540|NCT00983281|FG001|Participant Flow|Standard of Care|Patients that received standard of care but no Hextend as part of their resuscitation.
10985541|NCT00983281|OG000|Outcome|Hextend|Patients that received Hextend as part of their resuscitation fluid.
10985542|NCT00983281|OG001|Outcome|Standard of Care|PAtients that did not receive Hextend as part of their resuscitation fluid.
10985543|NCT00983281|EG000|Reported Event|Hextend|Patients that received Hextend as part of their resuscitation fluid.
10985544|NCT00983281|EG001|Reported Event|Standard of Care|Patients that received standard resuscitation but no Hextend as part of their resuscitation.
11336562|NCT03568539|BG002|Baseline|Total|Total of all reporting groups
11336563|NCT03568539|FG000|Participant Flow|Cohort 1|Advanced/metastatic cancers with TMB>10 mutations per megabase (mut/Mb). 200mg IV Q3W.
11336564|NCT03568539|FG001|Participant Flow|Cohort 2|Advanced/metastatic endometrial cancer. 200mg IV Q3W.
11336565|NCT03568539|OG000|Outcome|Cohort 1|Advanced/metastatic cancers with TMB>10 mutations per megabase (mut/Mb). 200mg IV Q3W.
10985545|NCT00983294|BG000|Baseline|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
10985546|NCT00983294|FG000|Participant Flow|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30 am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250mg azithromycin tablet at 7:30 am after an overnight fast.
10985547|NCT00983294|OG000|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
10985548|NCT00983294|OG001|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
10985549|NCT00983294|EG000|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days.
10985550|NCT00983294|EG001|Reported Event|Azithromycin Alone|On Day 15, each subject received two 250mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250mg azithromycin tablet daily at 07:30 without regard to meals on Days 16 to 18.
10985551|NCT00983294|EG002|Reported Event|Colchicine With Steady-state Azithromycin|On Day 19, each subject received both one 0.6mg colchicine tablet and one 250mg azithromycin tablet at 07:30 after an overnight fast.
10985552|NCT00983307|BG000|Baseline|Erlotinib and Radiotherapy|"Patients will be treated with Erlotinib and hypofractionated radiotherapy.~Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.~Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity."
10985553|NCT00983307|FG000|Participant Flow|Erlotinib and Radiotherapy|"Patients will be treated with Erlotinib and hypofractionated radiotherapy.~Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.~Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity."
10985554|NCT00983307|OG000|Outcome|Erlotinib and Radiotherapy|"Patients will be treated with Erlotinib and hypofractionated radiotherapy.~Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.~Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity."
10985555|NCT00983307|EG000|Reported Event|Erlotinib and Radiotherapy|"Patients will be treated with Erlotinib and hypofractionated radiotherapy.~Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.~Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity."
10985556|NCT00983346|BG000|Baseline|Arm -1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
10985557|NCT00983346|FG000|Participant Flow|Arm -1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
10985558|NCT00983346|OG000|Outcome|Arm 1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
11336566|NCT03568539|OG001|Outcome|Cohort 2|Advanced/metastatic endometrial cancer. 200mg IV Q3W.
10985559|NCT00983346|EG000|Reported Event|Arm 1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
10985560|NCT00983359|BG000|Baseline|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
10985561|NCT00983359|FG000|Participant Flow|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
10985562|NCT00983359|OG000|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
10985563|NCT00983359|EG000|Reported Event|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
10985564|NCT00983372|BG000|Baseline|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
10985565|NCT00983372|FG000|Participant Flow|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
10985566|NCT00983372|OG000|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
10985567|NCT00983372|OG001|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
10985568|NCT00983372|EG000|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
10985569|NCT00983372|EG001|Reported Event|Diltiazem Alone|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m.
10985570|NCT00983372|EG002|Reported Event|Colchicine With Steady-state Diltiazem|On Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
10985571|NCT00983385|BG000|Baseline|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
10985572|NCT00983385|FG000|Participant Flow|Tapentadol|All participants started with 50 mg tapentadol hydrochloride prolonged release (PR) (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride immediate release (IR) 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
10985573|NCT00983385|OG000|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
10985574|NCT00983385|OG000|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
10985575|NCT00983385|OG001|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
10985576|NCT00983385|OG002|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
10985577|NCT00983385|OG000|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
10985578|NCT00983385|OG001|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
10985579|NCT00983385|OG002|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
10985580|NCT00983385|OG000|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
10985581|NCT00983385|OG001|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
10985582|NCT00983385|OG002|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
10985583|NCT00983385|OG000|Outcome|Tapentadol|"Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total."
10985584|NCT00983385|OG000|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 6 in PainDetect specific subgroup of participants that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total."
10985585|NCT00983385|OG000|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in PainDetect specific subgroup of participants that entered the maintenance period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total."
10985586|NCT00983385|OG000|Outcome|Tapentadol|Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.
10985587|NCT00983385|OG000|Outcome|Tapentadol|"NRS-3 pain intensity values at end of Week 6 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total."
10985588|NCT00983385|OG000|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the maintenance period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total."
10985589|NCT00983385|EG000|Reported Event|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
10985590|NCT00983476|BG000|Baseline|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
10985591|NCT00983476|BG001|Baseline|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
10985592|NCT00983476|BG002|Baseline|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
10985593|NCT00983476|BG003|Baseline|Total|Total of all reporting groups
10985594|NCT00983476|FG000|Participant Flow|Arm 1: In-person MOVE! SMI|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
10985595|NCT00983476|FG001|Participant Flow|Arm 2: Web-based MOVE! SMI|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
10985596|NCT00983476|FG002|Participant Flow|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
10985597|NCT00983476|OG000|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
10985598|NCT00983476|OG001|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
10985599|NCT00983476|OG002|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
10985600|NCT00983476|OG000|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
10985601|NCT00983476|OG001|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
10985602|NCT00983476|OG000|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
10985603|NCT00983476|OG001|Outcome|Arm 2: Web-based MOVE! SMI|online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
10985604|NCT00983476|OG000|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
10985605|NCT00983476|OG001|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
10985606|NCT00983476|EG000|Reported Event|Arm 1: In-person MOVE! SMI|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
10985607|NCT00983476|EG001|Reported Event|Arm 2: Web-based MOVE! SMI|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
10985608|NCT00983476|EG002|Reported Event|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
10985609|NCT00983489|BG000|Baseline|Counselling|counselling: Breast feeding counselling will be done to mothers
10985610|NCT00983489|BG001|Baseline|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
10985611|NCT00983489|BG002|Baseline|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
10985612|NCT00983489|BG003|Baseline|Total|Total of all reporting groups
10985613|NCT00983489|FG000|Participant Flow|Counselling|counselling: Breast feeding counselling will be done to mothers
10985614|NCT00983489|FG001|Participant Flow|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
10985615|NCT00983489|FG002|Participant Flow|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
10985616|NCT00983489|OG000|Outcome|Counselling|counselling: Breast feeding counselling will be done to mothers
10985617|NCT00983489|OG001|Outcome|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
10985618|NCT00983489|OG002|Outcome|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
10985619|NCT00983489|EG000|Reported Event|Counselling|counselling: Breast feeding counselling will be done to mothers
10985620|NCT00983489|EG001|Reported Event|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
10985621|NCT00983489|EG002|Reported Event|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
10985622|NCT00983515|BG000|Baseline|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
10985623|NCT00983515|FG000|Participant Flow|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
10985624|NCT00983515|OG000|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
10985625|NCT00983515|OG001|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
10985626|NCT00983515|EG000|Reported Event|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
10985627|NCT00983515|EG001|Reported Event|Ritonavir Alone|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals.
10985628|NCT00983515|EG002|Reported Event|Colchicine With Steady-state Ritonavir|On Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
10985629|NCT00983528|BG000|Baseline|Alemtuzumab and Clofarabine|Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
10985630|NCT00983528|FG000|Participant Flow|Alemtuzumab and Clofarabine|Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
10985631|NCT00983528|OG000|Outcome|Alemtuzumab and Clofarabine|Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
10985632|NCT00983528|EG000|Reported Event|Alemtuzumab and Clofarabine|Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
10985633|NCT00983541|BG000|Baseline|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).~Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy~Gemcitabine"
10985634|NCT00983541|FG000|Participant Flow|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).~Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy~Gemcitabine"
10985635|NCT00983541|OG000|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
10985636|NCT00983541|EG000|Reported Event|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
10985637|NCT00983580|BG000|Baseline|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
10985638|NCT00983580|BG001|Baseline|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
10985639|NCT00983580|BG002|Baseline|Total|Total of all reporting groups
10985640|NCT00983580|FG000|Participant Flow|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO once daily on days 1-28.
10985641|NCT00983580|FG001|Participant Flow|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
10985642|NCT00983580|OG000|Outcome|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
10985643|NCT00983580|OG001|Outcome|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
10985644|NCT00983580|OG000|Outcome|All Patients|Patients from Arm I and Arm II were combined in this analysis
10985645|NCT00983580|EG000|Reported Event|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
10985646|NCT00983580|EG001|Reported Event|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
10985647|NCT00983619|BG000|Baseline|Part A-MEDI-551 0.5 mg/kg|Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985648|NCT00983619|BG001|Baseline|Part A-MEDI-551 1 mg/kg|Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985649|NCT00983619|BG002|Baseline|Part A-MEDI-551 2 mg/kg|Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985650|NCT00983619|BG003|Baseline|Part A-MEDI-551 4 mg/kg|Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985651|NCT00983619|BG004|Baseline|Part A-MEDI-551 8 mg/kg|Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985652|NCT00983619|BG005|Baseline|Part A-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985653|NCT00983619|BG006|Baseline|Part B-MEDI-551 6 mg/kg|Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985654|NCT00983619|BG007|Baseline|Part B-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985655|NCT00983619|BG008|Baseline|Part B-MEDI-551 24 mg/kg|Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985656|NCT00983619|BG009|Baseline|Part C-MEDI-551 8 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
11336567|NCT03568539|OG000|Outcome|Cohort 1 & 2|intensive PK sampling set. 200mg IV Q3W.
10985657|NCT00983619|BG010|Baseline|Part C-MEDI-551 12 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985658|NCT00983619|BG011|Baseline|Part D-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
10985659|NCT00983619|BG012|Baseline|TOTAL|Total of all reporting groups
10985660|NCT00983619|FG000|Participant Flow|Part A-MEDI-551 0.5 mg/kg|Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985661|NCT00983619|FG001|Participant Flow|Part A-MEDI-551 1 mg/kg|Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985662|NCT00983619|FG002|Participant Flow|Part A-MEDI-551 2 mg/kg|Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985663|NCT00983619|FG003|Participant Flow|Part A-MEDI-551 4 mg/kg|Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985664|NCT00983619|FG004|Participant Flow|Part A-MEDI-551 8 mg/kg|Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985665|NCT00983619|FG005|Participant Flow|Part A-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985666|NCT00983619|FG006|Participant Flow|Part B-MEDI-551 6 mg/kg|Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985667|NCT00983619|FG007|Participant Flow|Part B-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985668|NCT00983619|FG008|Participant Flow|Part B-MEDI-551 24 mg/kg|Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985669|NCT00983619|FG009|Participant Flow|Part C-MEDI-551 8 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985670|NCT00983619|FG010|Participant Flow|Part C-MEDI-551 12 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985671|NCT00983619|FG011|Participant Flow|Part D-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
10985672|NCT00983619|OG000|Outcome|Part A-MEDI-551 Part A|Participants received IV infusion of MEDI 551 0.5 or 1 mg/kg (both, once every week in 4-week cycles), or 2, or 4, or 8, or 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985673|NCT00983619|OG000|Outcome|Part B-MEDI-551|Participants received IV infusion of MEDI- 551 6 or 12 mg/kg weekly for 4 weeks during Cycle 1 (both from Days 1, 8, 15, and 22) or 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985674|NCT00983619|OG000|Outcome|Part C-MEDI-551 + Rituximab|Participants received IV infusion of MEDI- 551 8 or 12 mg/kg on days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 or 12 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdraws consent.
10985675|NCT00983619|OG000|Outcome|Part A-MEDI-551 0.5 mg/kg|Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985676|NCT00983619|OG001|Outcome|Part A-MEDI-551 1 mg/kg|Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985677|NCT00983619|OG002|Outcome|Part A-MEDI-551 2 mg/kg|Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985678|NCT00983619|OG003|Outcome|Part A-MEDI-551 4 mg/kg|Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985679|NCT00983619|OG004|Outcome|Part A-MEDI-551 8 mg/kg|Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985680|NCT00983619|OG005|Outcome|Part A-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985681|NCT00983619|OG006|Outcome|Part B-MEDI-551 6 mg/kg|Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985682|NCT00983619|OG007|Outcome|Part B-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985683|NCT00983619|OG008|Outcome|Part B-MEDI-551 24 mg/kg|Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985684|NCT00983619|OG009|Outcome|Part C-MEDI-551 8 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985685|NCT00983619|OG010|Outcome|Part C-MEDI-551 12 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985686|NCT00983619|OG000|Outcome|Part B-MEDI-551 6 mg/kg|Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985687|NCT00983619|OG001|Outcome|Part B-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985688|NCT00983619|OG002|Outcome|Part B-MEDI-551 24 mg/kg|Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985689|NCT00983619|OG003|Outcome|Part C-MEDI-551 8 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985690|NCT00983619|OG004|Outcome|Part C-MEDI-551 12 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985691|NCT00983619|OG005|Outcome|Part D-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
10985692|NCT00983619|OG000|Outcome|Part D-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
10985693|NCT00983619|OG006|Outcome|Part A-MEDI-551 12 mg/kg (Expansion)|Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985694|NCT00983619|OG007|Outcome|Part B-MEDI-551 6 mg/kg|Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985695|NCT00983619|OG008|Outcome|Part B-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985696|NCT00983619|OG009|Outcome|Part B-MEDI-551 24 mg/kg|Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985697|NCT00983619|OG010|Outcome|Part C-MEDI-551 8 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985698|NCT00983619|OG011|Outcome|Part C-MEDI-551 12 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985699|NCT00983619|OG012|Outcome|Part D-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
10985700|NCT00983619|OG008|Outcome|Part C-MEDI-551 8 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985701|NCT00983619|OG009|Outcome|Part C-MEDI-551 12 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985702|NCT00983619|OG010|Outcome|Part D-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
10985703|NCT00983619|OG011|Outcome|Part D-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
10985704|NCT00983619|EG000|Reported Event|Part A-MEDI-551 0.5 mg/kg|Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985705|NCT00983619|EG001|Reported Event|Part A-MEDI-551 1 mg/kg|Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985706|NCT00983619|EG002|Reported Event|Part A-MEDI-551 2 mg/kg|Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985707|NCT00983619|EG003|Reported Event|Part A-MEDI-551 4 mg/kg|Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985708|NCT00983619|EG004|Reported Event|Part A-MEDI-551 8 mg/kg|Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985709|NCT00983619|EG005|Reported Event|Part A-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985710|NCT00983619|EG006|Reported Event|Part B-MEDI-551 6 mg/kg|Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985711|NCT00983619|EG007|Reported Event|Part B-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985712|NCT00983619|EG008|Reported Event|Part B-MEDI-551 24 mg/kg|Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
10985713|NCT00983619|EG009|Reported Event|Part C-MEDI-551 8 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
11007236|NCT01090011|OG001|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
10875188|NCT00436982|OG000|Outcome|Cemented Triathlon Total Knee System|"30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Cemented Triathlon total knee system: Orthopaedic implant"
10875189|NCT00436982|OG001|Outcome|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
10875190|NCT00436982|OG000|Outcome|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
10875191|NCT00436982|OG001|Outcome|Triathlon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Triathlon total knee system: Orthopaedic implant"
10875192|NCT00436982|EG000|Reported Event|Triathlon|30 patients randomized into the Triathlon arm
10875193|NCT00436982|EG001|Reported Event|Duracon|30 patients randomized into the Duracon arm
10875194|NCT00437034|BG000|Baseline|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
10875195|NCT00437034|FG000|Participant Flow|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
10875196|NCT00437034|OG000|Outcome|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
10875197|NCT00437034|EG000|Reported Event|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
10875198|NCT00437073|BG000|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
10875199|NCT00437073|BG001|Baseline|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
10875200|NCT00437073|BG002|Baseline|Total|Total of all reporting groups
10875201|NCT00437073|FG000|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
10875202|NCT00437073|FG001|Participant Flow|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
10875203|NCT00437073|OG000|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
10875204|NCT00437073|OG001|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
10875205|NCT00437073|EG000|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
10875206|NCT00437073|EG001|Reported Event|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
10875207|NCT00437125|BG000|Baseline|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
10875208|NCT00437125|FG000|Participant Flow|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
10875209|NCT00437125|OG000|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
10985714|NCT00983619|EG010|Reported Event|Part C-MEDI-551 12 mg/kg + Rituximab|Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
10985715|NCT00983619|EG011|Reported Event|Part D-MEDI-551 12 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
10985716|NCT00983749|BG000|Baseline|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
10985717|NCT00983749|BG001|Baseline|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
10985718|NCT00983749|BG002|Baseline|Total|Total of all reporting groups
10985719|NCT00983749|FG000|Participant Flow|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
10985720|NCT00983749|FG001|Participant Flow|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
10985721|NCT00983749|OG000|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
10985722|NCT00983749|OG001|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
10985723|NCT00983749|EG000|Reported Event|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
10985724|NCT00983749|EG001|Reported Event|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
10985725|NCT00983801|BG000|Baseline|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
10985726|NCT00983801|FG000|Participant Flow|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
10985727|NCT00983801|OG000|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
10985728|NCT00983801|EG000|Reported Event|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
10985729|NCT00983827|BG000|Baseline|Aquatic Treadmill Training|
10985730|NCT00983827|FG000|Participant Flow|Aquatic Treadmill Training|Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality.
10985731|NCT00983827|OG000|Outcome|Aquatic Treadmill Training|
10985732|NCT00983827|EG000|Reported Event|Aquatic Treadmill Training|
10985733|NCT00983853|BG000|Baseline|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
10985734|NCT00983853|BG001|Baseline|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
10985735|NCT00983853|BG002|Baseline|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
10985736|NCT00983853|BG003|Baseline|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
10985737|NCT00983853|BG004|Baseline|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
10985738|NCT00983853|BG005|Baseline|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
10985739|NCT00983853|BG006|Baseline|Total|Total of all reporting groups
10985740|NCT00983853|FG000|Participant Flow|Part A: T/PR|"Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
10985741|NCT00983853|FG001|Participant Flow|Part A: Pbo/PR|"Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
11007237|NCT01090011|OG000|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
10985742|NCT00983853|FG002|Participant Flow|Part B: EFV-based HAART + T/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine~Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
10985743|NCT00983853|FG003|Participant Flow|Part B: EFV-based HAART + Pbo/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine~Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
10985744|NCT00983853|FG004|Participant Flow|Part B: ATV/R-based HAART + T/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine~Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
10985745|NCT00983853|FG005|Participant Flow|Part B: ATV/R-based HAART + Pbo/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine~Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
10985746|NCT00983853|OG000|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
10985747|NCT00983853|OG001|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
10985748|NCT00983853|OG002|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
10985749|NCT00983853|OG003|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
10985750|NCT00983853|OG004|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
10985751|NCT00983853|OG005|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
10985752|NCT00983853|OG000|Outcome|EFV-based (Test, N=15) vs No HAART (Reference, N=7)|
10985753|NCT00983853|OG001|Outcome|ATV/R-based (Test, N=13) vs No HAART (Reference, N=7)|
10985754|NCT00983853|OG000|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
10985755|NCT00983853|OG001|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
10985756|NCT00983853|OG000|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
10985757|NCT00983853|OG001|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
10985758|NCT00983853|EG000|Reported Event|T/PR|Pooled T/PR from Part A and Part B
10985759|NCT00983853|EG001|Reported Event|Total PR|Pooled PR from Part A and Part B
10985760|NCT00983892|BG000|Baseline|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
10985761|NCT00983892|BG001|Baseline|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
10985762|NCT00983892|BG002|Baseline|Total|Total of all reporting groups
10985763|NCT00983892|FG000|Participant Flow|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
10985764|NCT00983892|FG001|Participant Flow|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
11336568|NCT03568539|EG000|Reported Event|Cohort 1|Advanced/metastatic cancers with TMB>10 mutations per megabase (mut/Mb). 200mg IV Q3W.
11336569|NCT03568539|EG001|Reported Event|Cohort 2|Advanced/metastatic endometrial cancer 200mg IV Q3W.
10875210|NCT00437125|EG000|Reported Event|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
10875211|NCT00437203|BG000|Baseline|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875212|NCT00437203|BG001|Baseline|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875213|NCT00437203|BG002|Baseline|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875214|NCT00437203|BG003|Baseline|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875215|NCT00437203|BG004|Baseline|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875216|NCT00437203|BG005|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875217|NCT00437203|BG006|Baseline|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875218|NCT00437203|BG007|Baseline|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875219|NCT00437203|BG008|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875220|NCT00437203|BG009|Baseline|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875221|NCT00437203|BG010|Baseline|Total|Total of all reporting groups
10875222|NCT00437203|FG000|Participant Flow|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 milligram (mg) 3 hours (hrs) infusion intravenously (IV) on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg per square meter (mg/m^2) 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875223|NCT00437203|FG001|Participant Flow|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875224|NCT00437203|FG002|Participant Flow|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875225|NCT00437203|FG003|Participant Flow|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875226|NCT00437203|FG004|Participant Flow|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875227|NCT00437203|FG005|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
11336570|NCT03568942|BG000|Baseline|Gepotidacin 1500 mg|All participants received gepotidacin 1500 mg (2*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
10875228|NCT00437203|FG006|Participant Flow|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10985765|NCT00983892|OG000|Outcome|CarePartners Intervention +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
10985766|NCT00983892|OG001|Outcome|Control|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
10985767|NCT00983892|EG000|Reported Event|CarePartners+|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
10985768|NCT00983892|EG001|Reported Event|CarePartners-|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
11007238|NCT01090011|OG002|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
11007239|NCT01090011|OG003|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
11007240|NCT01090011|OG002|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
11007241|NCT01090011|EG000|Reported Event|Combination Arm - Afa40+Ctx250|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
11007242|NCT01090011|EG001|Reported Event|Combination Arm - Afa40+Ctx500|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
11007243|NCT01090011|EG002|Reported Event|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
11007244|NCT01090011|EG003|Reported Event|Sequential Arm - Combination Therapy (Afa40+Ctx500)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
11007245|NCT01090050|BG000|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Treximet will treat daily with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Treximet for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Treximet will be provided with 14 tablets of Treximet to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Treximet per month for rescue.
11007246|NCT01090050|BG001|Baseline|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to naproxen will treat daily with 1 tablet naproxen 500mg per day x 30 days. Subjects will be provided with 30 tablets of naproxen 500mg for rescue. In Treatment Period Months 2 and 3: Subjects randomized to naproxen will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of naproxen 500mg per month for rescue.
10846410|NCT00275821|BG002|Baseline|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
11007247|NCT01090050|BG002|Baseline|Total|Total of all reporting groups
11007248|NCT01090050|FG000|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
11007249|NCT01090050|FG001|Participant Flow|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
11007250|NCT01090050|OG000|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen will treat daily with 1 tablet Sumatriptan/Naproxen per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen will be provided with 14 tablets of Sumatriptan/Naproxen to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen per month for rescue.
11007251|NCT01090050|OG001|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
10985769|NCT00983905|BG000|Baseline|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
10985770|NCT00983905|FG000|Participant Flow|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
10985771|NCT00983905|OG000|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
10985772|NCT00983905|OG001|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
10985773|NCT00983905|EG000|Reported Event|Theophylline Alone|Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
10985774|NCT00983905|EG001|Reported Event|Colchicine Alone|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals.
10985775|NCT00983905|EG002|Reported Event|Theophylline With Steady-state Colchicine|On Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45 am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
10985776|NCT00983918|BG000|Baseline|Desflurane|General Anesthesia with Desflurane
10985777|NCT00983918|BG001|Baseline|Sevoflurane|General Anesthesia with Sevoflurane
10985778|NCT00983918|BG002|Baseline|Isoflurane|General Anesthesia with Isoflurane
10985779|NCT00983918|BG003|Baseline|Propofol|General Anesthesia with Propofol
10985780|NCT00983918|BG004|Baseline|Total|Total of all reporting groups
10985781|NCT00983918|FG000|Participant Flow|Desflurane|General Anesthesia with Desflurane
10985782|NCT00983918|FG001|Participant Flow|Sevoflurane|General Anesthesia with Sevoflurane
10985783|NCT00983918|FG002|Participant Flow|Isoflurane|General Anesthesia with Isoflurane
10985784|NCT00983918|FG003|Participant Flow|Propofol|General Anesthesia with Propofol
10985785|NCT00983918|OG000|Outcome|Desflurane|General Anesthesia with Desflurane
10985786|NCT00983918|OG001|Outcome|Sevoflurane|General Anesthesia with Sevoflurane
10985787|NCT00983918|OG002|Outcome|Isoflurane|General Anesthesia with Isoflurane
10985788|NCT00983918|OG003|Outcome|Propofol|General Anesthesia with Propofol
10985789|NCT00983918|EG000|Reported Event|Desflurane|General Anesthesia with Desflurane
10985790|NCT00983918|EG001|Reported Event|Sevoflurane|General Anesthesia with Sevoflurane
10985791|NCT00983918|EG002|Reported Event|Isoflurane|General Anesthesia with Isoflurane
10985792|NCT00983918|EG003|Reported Event|Propofol|General Anesthesia with Propofol
10985793|NCT00983931|BG000|Baseline|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
10985794|NCT00983931|FG000|Participant Flow|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
10985795|NCT00983931|OG000|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
10985796|NCT00983931|OG001|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
10985797|NCT00983931|EG000|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
10985798|NCT00983931|EG001|Reported Event|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
10985799|NCT00983957|BG000|Baseline|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
11336571|NCT03568942|FG000|Participant Flow|Gepotidacin 1500 mg|All participants received gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
10846411|NCT00275821|BG003|Baseline|Total|Total of all reporting groups
10985800|NCT00983957|FG000|Participant Flow|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
10985801|NCT00983957|OG000|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
10985802|NCT00983957|OG001|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
10985803|NCT00983957|EG000|Reported Event|All Treated Participants|Participants received sequentially Treatment A: Ortho Tri-Cyclen (OTC) fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 along with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
10985804|NCT00983957|EG001|Reported Event|Ortho Tri-Cyclen Days 1-28|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28.
10985805|NCT00983957|EG002|Reported Event|Ortho Tri-Cyclen Days 29-46|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 46.
10985806|NCT00983957|EG003|Reported Event|Ortho Tri-Cyclen Days 47-56|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 47 to 56.
10985807|NCT00983957|EG004|Reported Event|Ortho Tri-Cyclen Days 57-67|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67.
10985808|NCT00983957|EG005|Reported Event|Ortho Tri-Cyclen + Daclatasvir Days 68-77|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67 along with daclatasvir two tablets of 30-mg, orally, once daily from Day 68 to 77.
10985809|NCT00983983|BG000|Baseline|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985810|NCT00983983|BG001|Baseline|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985811|NCT00983983|BG002|Baseline|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985812|NCT00983983|BG003|Baseline|Total|Total of all reporting groups
10985813|NCT00983983|FG000|Participant Flow|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985814|NCT00983983|FG001|Participant Flow|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985815|NCT00983983|FG002|Participant Flow|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985816|NCT00983983|OG000|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985817|NCT00983983|OG001|Outcome|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985818|NCT00983983|OG002|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985819|NCT00983983|OG001|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985820|NCT00983983|EG000|Reported Event|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985821|NCT00983983|EG001|Reported Event|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985822|NCT00983983|EG002|Reported Event|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
10985823|NCT00984009|BG000|Baseline|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
10985824|NCT00984009|FG000|Participant Flow|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
10985825|NCT00984009|OG000|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
10985826|NCT00984009|OG001|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
10985827|NCT00984009|EG000|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
10985828|NCT00984009|EG001|Reported Event|Grapefruit Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals.
10985829|NCT00984009|EG002|Reported Event|Colchicine With Grapefruit Juice|On Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
10985830|NCT00984022|BG000|Baseline|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
10985831|NCT00984022|BG001|Baseline|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
10985832|NCT00984022|BG002|Baseline|Total|Total of all reporting groups
10985833|NCT00984022|FG000|Participant Flow|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
10985834|NCT00984022|FG001|Participant Flow|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
10985835|NCT00984022|OG000|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
10985836|NCT00984022|OG001|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
10985837|NCT00984022|EG000|Reported Event|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
10985838|NCT00984022|EG001|Reported Event|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
10985839|NCT00984061|BG000|Baseline|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
10985840|NCT00984061|FG000|Participant Flow|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
10985841|NCT00984061|OG000|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
10985842|NCT00984061|OG001|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
10985843|NCT00984061|EG000|Reported Event|Colchicine Alone|On the morning of Day 1 after a fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg.
10875229|NCT00437203|FG007|Participant Flow|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875230|NCT00437203|FG008|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875231|NCT00437203|FG009|Participant Flow|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875232|NCT00437203|OG000|Outcome|PF-00477736 + Gemcitabine 750 mg/m^2|PF-00477736 infusion 50 mg, 65 mg or 80 mg IV administered over 3 hrs on Days 1 and 8 of Cycle 0 (21 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle), or PF-00477736 infusion 80 mg, 120 mg, 180 mg, 270 mg or 340 mg IV administered over 24 hrs on Days 1 and 8 of Cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 750 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875233|NCT00437203|OG001|Outcome|PF-00477736 + Gemcitabine 1000 mg/m^2|PF-00477736 infusion 180 mg or 225 mg IV administered over 24 hrs on Days 2 and 9 of each cycle (21 days cycle) along with gemcitabine infusion 1000 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875234|NCT00437203|OG000|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875235|NCT00437203|OG001|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875236|NCT00437203|OG002|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875237|NCT00437203|OG003|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875238|NCT00437203|OG004|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875239|NCT00437203|OG005|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875240|NCT00437203|OG006|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875241|NCT00437203|OG007|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875242|NCT00437203|OG008|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875243|NCT00437203|OG009|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875244|NCT00437203|OG000|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875245|NCT00437203|OG001|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875246|NCT00437203|OG002|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875247|NCT00437203|OG003|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10985844|NCT00984061|EG001|Reported Event|Clarithromycin Alone|On the evening of Day 22, subjects began taking (on an outpatient basis) one tablet of clarithromycin 250 mg every 12 hours for 7 days without regard to meals.
10985845|NCT00984061|EG002|Reported Event|Colchicine With Clarithromycin|On the morning of Day 29 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with the last dose of clarithromycin.
10985846|NCT00984126|BG000|Baseline|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
10985847|NCT00984126|BG001|Baseline|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985848|NCT00984126|BG002|Baseline|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985849|NCT00984126|BG003|Baseline|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985850|NCT00984126|BG004|Baseline|Total|Total of all reporting groups
10985851|NCT00984126|FG000|Participant Flow|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
10985852|NCT00984126|FG001|Participant Flow|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
11007252|NCT01090050|OG000|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
11336572|NCT03568942|OG000|Outcome|Gepotidacin 1500 mg|All participants received gepotidacin 1500 mg (2*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
10985853|NCT00984126|FG002|Participant Flow|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly.On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985854|NCT00984126|FG003|Participant Flow|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985855|NCT00984126|OG000|Outcome|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
10985856|NCT00984126|OG001|Outcome|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985857|NCT00984126|OG002|Outcome|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985858|NCT00984126|OG003|Outcome|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985859|NCT00984126|OG000|Outcome|Small Children (0 - <6 Years)-Preventive Regimen [Main Trial]|Subjects (0-<6 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or trial site was terminated by Novo Nordisk or relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009-30 Jun 2016). Preventive regimen: turoctocog alfa as slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly.
11336573|NCT03568942|EG000|Reported Event|Gepotidacin 1500 mg|All participants received gepotidacin 1500 mg (2*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
10985860|NCT00984126|OG001|Outcome|Older Children (6 - <12 Years)-Preventive Regimen [Main Trial]|Subjects (6-<12 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 - 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg three times weekly or 40-60 IU/kg once every third day or twice weekly.
10985861|NCT00984126|OG002|Outcome|Adolescents (12 - <18 Years)-Preventive Regimen [Main Trial]|Subjects (12-<18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 - 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg three times weekly or 40-60 IU/kg once every third day or twice weekly.
10985862|NCT00984126|OG003|Outcome|Adults (≥18 Years)-Preventive Regimen [Main Trial]|Subjects (>=18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 - 30 Jun 2016). Preventive regimen: Turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg three times weekly or 40-60 IU/kg once every third day or twice weekly.
10985863|NCT00984126|OG002|Outcome|Adolescents (12 - <18 Years) - Preventive Regimen [Main Trial]|Subjects (12-<18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 - 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg three times weekly or 40-60 IU/kg once every third day or twice weekly.
10985864|NCT00984126|OG003|Outcome|Adults (>= 18 Years) - Preventive Regimen [Main Trial]|Subjects (>=18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 - 30 Jun 2016). Preventive regimen: Turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg three times weekly or 40-60 IU/kg once every third day or twice weekly.
10985865|NCT00984126|OG004|Outcome|Adolescents (12-<18 Years)-(On-Demand Regimen [Main Trial])|Subjects (12-<18 Years) in main trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009-30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
11007253|NCT01090050|OG000|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
11348163|NCT04207840|OG001|Outcome|Epinephrine Injection Auto-Injector (Generic of EpiPen)|"Participants who were dosed with an Epinephrine Injection Auto-Injector.~Epinephrine Injection Auto-Injector (0.3mg/0.3mL): Participants will receive an intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL). The 0.30 mL dose will be given perpendicularly as a single deep intramuscular injection into the anterolateral aspect of the thigh."
10985866|NCT00984126|OG005|Outcome|Adults (>=18 Years)-(On-Demand Regimen [Main Trial])|Subjects (≥18 Years) in main trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 - 30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
10985867|NCT00984126|OG006|Outcome|Adults (>=18 Years)-(On-Demand Regimen [Sub-trial])|Subjects (≥18 Years) in sub-trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 - 30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
10985868|NCT00984126|EG000|Reported Event|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985869|NCT00984126|EG001|Reported Event|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day, 20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985870|NCT00984126|EG002|Reported Event|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985871|NCT00984126|EG003|Reported Event|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators' discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20-50 IU/kg once every second day,20-60 IU/kg 3 times weekly or 40-60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until the trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
10985872|NCT00984139|BG000|Baseline|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
10985873|NCT00984139|FG000|Participant Flow|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
10985874|NCT00984139|OG000|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
10985875|NCT00984139|EG000|Reported Event|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
10985876|NCT00984165|BG000|Baseline|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
10985877|NCT00984165|BG001|Baseline|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
10875248|NCT00437203|OG004|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875249|NCT00437203|OG005|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875250|NCT00437203|OG006|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875251|NCT00437203|EG000|Reported Event|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875252|NCT00437203|EG001|Reported Event|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875253|NCT00437203|EG002|Reported Event|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875254|NCT00437203|EG003|Reported Event|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875255|NCT00437203|EG004|Reported Event|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875256|NCT00437203|EG005|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875257|NCT00437203|EG006|Reported Event|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875258|NCT00437203|EG007|Reported Event|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
10875259|NCT00437203|EG008|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875260|NCT00437203|EG009|Reported Event|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
10875261|NCT00437268|BG000|Baseline|Enzastaurin+Irinotecan+Cetuximab|"Enzastaurin: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1, then 500 mg orally, daily, of each 21-day cycle until progressive disease~Irinotecan: 300 mg/m^2 intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 in Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875262|NCT00437268|BG001|Baseline|Irinotecan+Cetuximab|"Irinotecan: 300 mg/m^2 intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 in Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875263|NCT00437268|BG002|Baseline|Total|Total of all reporting groups
10875264|NCT00437268|FG000|Participant Flow|Enzastaurin+Irinotecan+Cetuximab|"Enzastaurin: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1, then 500 mg orally, daily, of each 21-day cycle until progressive disease~Irinotecan: 300 milligrams per square meter (mg/m^2), intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 of Cycle 1, then 250 mg/m^2 on Days 8 and 15 in Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875265|NCT00437268|FG001|Participant Flow|Irinotecan+Cetuximab|"Irinotecan: 300 mg/m^2 intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 in Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875266|NCT00437268|OG000|Outcome|Enzastaurin+Irinotecan+Cetuximab|"Enzastaurin: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1, then 500 mg orally, daily, of each 21-day cycle until progressive disease~Irinotecan: 300 mg/m^2 intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 in Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10985878|NCT00984165|BG002|Baseline|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
10985879|NCT00984165|BG003|Baseline|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
10985880|NCT00984165|BG004|Baseline|Total|Total of all reporting groups
10985881|NCT00984165|FG000|Participant Flow|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
10985882|NCT00984165|FG001|Participant Flow|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
10985883|NCT00984165|FG002|Participant Flow|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
10985884|NCT00984165|FG003|Participant Flow|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
10985885|NCT00984165|OG000|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
10985886|NCT00984165|OG001|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
10985887|NCT00984165|OG002|Outcome|Donor Lymphocyte Infusion-Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
10985888|NCT00984165|OG002|Outcome|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
10985889|NCT00984165|OG003|Outcome|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
10985890|NCT00984165|EG000|Reported Event|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
10985891|NCT00984165|EG001|Reported Event|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
10985892|NCT00984165|EG002|Reported Event|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
10985893|NCT00984165|EG003|Reported Event|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
10985894|NCT00984204|BG000|Baseline|Treatment Arm|
10985895|NCT00984204|FG000|Participant Flow|Treatment Arm|
10985896|NCT00984204|OG000|Outcome|Treatment Arm|
10985897|NCT00984204|EG000|Reported Event|Treatment Arm|
10985898|NCT00984256|BG000|Baseline|Malarone|"Thirty (30) subjects were placed in the Malarone (treatment) Arm. The thirty subjects were then randomized into 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge. The groups received treatment as follows:~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
10985899|NCT00984256|BG001|Baseline|Control|The six (6) Control volunteers were enrolled in a open label arm and received no treatment prior to malaria challenge.
10985900|NCT00984256|BG002|Baseline|Total|Total of all reporting groups
10985901|NCT00984256|FG000|Participant Flow|Control|The six volunteers in control cohort were enrolled as infectivity controls and did not undergo randomization or receive any study drug.
10985902|NCT00984256|FG001|Participant Flow|Malarone Treatment|"Within the Malarone Arm, thirty volunteers were randomized into the below 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
10985903|NCT00984256|OG000|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
10985904|NCT00984256|OG001|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
10985905|NCT00984256|OG002|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
10985906|NCT00984256|OG003|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
10985907|NCT00984256|OG004|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
10985908|NCT00984256|OG005|Outcome|Control|Six volunteers for the control cohort were enrolled as an infectivity control and did not undergo drug dosing.
10985909|NCT00984256|OG000|Outcome|Prophylaxis Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
10985910|NCT00984256|OG001|Outcome|Prophylaxis Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
10985911|NCT00984256|OG002|Outcome|Prophylaxis Group 3|(Group 3)Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
10985912|NCT00984256|OG003|Outcome|Prophylaxis Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
10985913|NCT00984256|OG004|Outcome|Prophylaxis Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
10985914|NCT00984256|EG000|Reported Event|Drug|"Partially randomized, double-blind, placebo-controlled trial using a human Plasmodium falciparum challenge to evaluate malaria chemoprophylaxis of Malarone in 36 healthy adults. Subjects were enrolled in 1 of 2 cohorts based on subject preference. Thirty subjects were placed in the prophylaxis cohort (Cohort 1) and 6 subjects were placed in the control cohort (Cohort 2)~5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
10985915|NCT00984256|EG001|Reported Event|Control|no malarone prophylaxis received
10985916|NCT00984282|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
10985917|NCT00984282|BG001|Baseline|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle.
10985918|NCT00984282|BG002|Baseline|Total|Total of all reporting groups
10985919|NCT00984282|FG000|Participant Flow|DB Sorafenib First, Then Option of OL Sorafenib Treatment|Double-blind period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Open-label (OL) period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
10985920|NCT00984282|FG001|Participant Flow|DB Placebo First, Then Option of OL Sorafenib Treatment|Double-blind period: participants received matching placebo tablets orally twice daily, 28 days comprised a cycle. Open-label (OL) period: participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle.
10985921|NCT00984282|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
10985922|NCT00984282|OG001|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
10985923|NCT00984282|EG000|Reported Event|Sorafenib (Double Blind Only)|Reporting Group 1: Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double blind period
10985924|NCT00984282|EG001|Reported Event|Placebo (Double Blind Only)|Reporting Group 2: Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double-blind period.
10985925|NCT00984282|EG002|Reported Event|Sorafenib, Open Label Only (Sorafenib Continued)|Reporting Group 3: Participants on sorafenib who continued OL sorafenib treat., received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of OL period to the data cutoff on 31 Aug
10985926|NCT00984282|EG003|Reported Event|Placebo, Open Label Only (Switch to Sorafenib)|Reporting Group 3: Participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of open label period to the data cutoff on 31 Aug 20
10985927|NCT00984295|BG000|Baseline|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
10985928|NCT00984295|BG001|Baseline|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
10985929|NCT00984295|BG002|Baseline|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
10985930|NCT00984295|BG003|Baseline|Total|Total of all reporting groups
10985931|NCT00984295|FG000|Participant Flow|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
10985932|NCT00984295|FG001|Participant Flow|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
10985933|NCT00984295|FG002|Participant Flow|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
10985934|NCT00984295|OG000|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
10985935|NCT00984295|OG001|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
10985936|NCT00984295|OG002|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
10985937|NCT00984295|EG000|Reported Event|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
10985938|NCT00984295|EG001|Reported Event|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
10985939|NCT00984295|EG002|Reported Event|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
10985940|NCT00984308|BG000|Baseline|Intervention|
10985941|NCT00984308|BG001|Baseline|Control|
10875267|NCT00437268|OG001|Outcome|Irinotecan+Cetuximab|"Irinotecan: 300 mg/m^2 intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 in Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875268|NCT00437268|OG001|Outcome|Irinotecan+Cetuximab|"Irinotecan: 300 milligrams per square meter (mg/m^2), intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 of Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875269|NCT00437268|OG000|Outcome|Enzastaurin+Irinotecan+Cetuximab|"Enzastaurin: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1, then 500 mg orally, daily, of each 21-day cycle until progressive disease~Irinotecan: 300 milligrams per square meter (mg/m^2), intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 of Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875270|NCT00437268|EG000|Reported Event|Enzastaurin+Irinotecan+Cetuximab|"Enzastaurin: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1, then 500 mg orally, daily, of each 21-day cycle until progressive disease~Irinotecan: 300 milligrams per square meter (mg/m^2), intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 of Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875271|NCT00437268|EG001|Reported Event|Irinotecan+Cetuximab|"Irinotecan: 300 mg/m^2 intravenously on Day 1 of each 21-day cycle until progressive disease~Cetuximab: 400 mg/m^2 intravenously on Day 1, then 250 mg/m^2 on Days 8 and 15 in Cycle 1, then 250 mg/m^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease"
10875272|NCT00437281|BG000|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875273|NCT00437281|BG001|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875274|NCT00437281|BG002|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875275|NCT00437281|BG003|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875276|NCT00437281|BG004|Baseline|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875277|NCT00437281|BG005|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875278|NCT00437281|BG006|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875279|NCT00437281|BG007|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875280|NCT00437281|BG008|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875281|NCT00437281|BG009|Baseline|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875282|NCT00437281|BG010|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10985942|NCT00984308|BG002|Baseline|Total|Total of all reporting groups
10875283|NCT00437281|BG011|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875284|NCT00437281|BG012|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875285|NCT00437281|BG013|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875286|NCT00437281|BG014|Baseline|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875287|NCT00437281|BG015|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875288|NCT00437281|BG016|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875289|NCT00437281|BG017|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875290|NCT00437281|BG018|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875291|NCT00437281|BG019|Baseline|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10985943|NCT00984308|FG000|Participant Flow|Intervention|The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
10875292|NCT00437281|BG020|Baseline|Total|Total of all reporting groups
10875293|NCT00437281|FG000|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875294|NCT00437281|FG001|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875295|NCT00437281|FG002|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875296|NCT00437281|FG003|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875297|NCT00437281|FG004|Participant Flow|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875298|NCT00437281|FG005|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10985944|NCT00984308|FG001|Participant Flow|Control|The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
10985945|NCT00984308|OG000|Outcome|Intervention|
10985946|NCT00984308|OG001|Outcome|Control|
10985947|NCT00984308|EG000|Reported Event|Intervention|
10985948|NCT00984308|EG001|Reported Event|Control|
10985949|NCT00984334|BG000|Baseline|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
10985950|NCT00984334|BG001|Baseline|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
10985951|NCT00984334|BG002|Baseline|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
10985952|NCT00984334|BG003|Baseline|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
10985953|NCT00984334|BG004|Baseline|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
10985954|NCT00984334|BG005|Baseline|Total|Total of all reporting groups
10985955|NCT00984334|FG000|Participant Flow|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
10985956|NCT00984334|FG001|Participant Flow|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
10985957|NCT00984334|FG002|Participant Flow|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
10985958|NCT00984334|FG003|Participant Flow|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
10985959|NCT00984334|FG004|Participant Flow|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
10985960|NCT00984334|OG000|Outcome|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
10985961|NCT00984334|OG001|Outcome|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
10985962|NCT00984334|OG002|Outcome|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
10985963|NCT00984334|OG003|Outcome|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
10985964|NCT00984334|OG004|Outcome|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
10985965|NCT00984334|EG000|Reported Event|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
10985966|NCT00984334|EG001|Reported Event|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
10985967|NCT00984334|EG002|Reported Event|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
10985968|NCT00984334|EG003|Reported Event|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
10985969|NCT00984334|EG004|Reported Event|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
10985970|NCT00984542|BG000|Baseline|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
10985971|NCT00984542|FG000|Participant Flow|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
10985972|NCT00984542|OG000|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
10985973|NCT00984542|OG000|Outcome|Bendatmustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
10985974|NCT00984542|EG000|Reported Event|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
10985975|NCT00984568|BG000|Baseline|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
10985976|NCT00984568|BG001|Baseline|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
10985977|NCT00984568|BG002|Baseline|Total|Total of all reporting groups
10985978|NCT00984568|FG000|Participant Flow|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
10985979|NCT00984568|FG001|Participant Flow|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
10985980|NCT00984568|OG000|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
10985981|NCT00984568|OG001|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
10875299|NCT00437281|FG006|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875300|NCT00437281|FG007|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875301|NCT00437281|FG008|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875302|NCT00437281|FG009|Participant Flow|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875303|NCT00437281|FG010|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875304|NCT00437281|FG011|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875305|NCT00437281|FG012|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875306|NCT00437281|FG013|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875307|NCT00437281|FG014|Participant Flow|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875308|NCT00437281|FG015|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875309|NCT00437281|FG016|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875310|NCT00437281|FG017|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875311|NCT00437281|FG018|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875312|NCT00437281|FG019|Participant Flow|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10985982|NCT00984568|EG000|Reported Event|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
10875313|NCT00437281|OG000|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
11098993|NCT01579162|BG000|Baseline|Healthy Controls|"Healthy controls will be recruited to have approximately equal numbers of men and women. Controls will be of healthy weight as defined by a BMI 18-25 and without liver disease or risk factors for liver disease.~Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
10875314|NCT00437281|OG001|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875315|NCT00437281|OG002|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875316|NCT00437281|OG003|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875317|NCT00437281|OG004|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875318|NCT00437281|OG005|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875319|NCT00437281|OG006|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875320|NCT00437281|OG007|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875321|NCT00437281|OG008|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875322|NCT00437281|OG009|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875323|NCT00437281|OG010|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875324|NCT00437281|OG011|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
11348164|NCT04207840|OG002|Outcome|Albuterol HFA|"Participants who dosed with Albuterol HFA.~Albuterol Sulfate (0.09 mg/inhalation): Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg."
10875325|NCT00437281|OG012|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875326|NCT00437281|OG013|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875327|NCT00437281|OG014|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10985983|NCT00984568|EG001|Reported Event|Step-Up|"Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2~g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter."
10985984|NCT00984594|BG000|Baseline|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
10985985|NCT00984594|BG001|Baseline|Primary|CR Plug will be placed in the site of the primary injury
10985986|NCT00984594|BG002|Baseline|Total|Total of all reporting groups
10985987|NCT00984594|FG000|Participant Flow|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
10985988|NCT00984594|FG001|Participant Flow|Primary|CR Plug will be placed in the site of the primary injury.
10985989|NCT00984594|OG000|Outcome|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
10985990|NCT00984594|OG001|Outcome|Primary|CR Plug will be placed in the site of the primary injury
10985991|NCT00984594|OG000|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
10985992|NCT00984594|OG001|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
10985993|NCT00984594|EG000|Reported Event|Backfill|CR-Plug will be placed in harvest site.
10985994|NCT00984594|EG001|Reported Event|Primary|Autograft will be placed in primary defect site.
10985995|NCT00984620|BG000|Baseline|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
10985996|NCT00984620|BG001|Baseline|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
10985997|NCT00984620|BG002|Baseline|Total|Total of all reporting groups
10985998|NCT00984620|FG000|Participant Flow|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
10985999|NCT00984620|FG001|Participant Flow|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
10986000|NCT00984620|OG000|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
10986001|NCT00984620|OG001|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
10986002|NCT00984620|OG000|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
10986003|NCT00984620|OG001|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
10986004|NCT00984620|EG000|Reported Event|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks.
10986005|NCT00984620|EG001|Reported Event|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).
10986006|NCT00984659|BG000|Baseline|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
10986007|NCT00984659|BG001|Baseline|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
10986008|NCT00984659|BG002|Baseline|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID
10986009|NCT00984659|BG003|Baseline|Albuterol and/or Ipratropium: Run-in Failure|Participants who entered the 2-week Run-in Period, during which they were permitted to use albuterol and/or ipratropium as rescue medication, but then failed to be randomized, or were randomized but did not receive a dose of study medication
10986010|NCT00984659|BG004|Baseline|Total|Total of all reporting groups
10986011|NCT00984659|FG000|Participant Flow|Albuterol and/or Ipratropium: Run-in Period|Participants were permitted to use albuterol and/or ipratropium as rescue medication during the 2-week Run-in Period
10986012|NCT00984659|FG001|Participant Flow|Placebo: Double-blind Treatment Period|Matching placebo via DISKUS, administered as one inhalation twice daily (BID) during the 6-week Double-blind Treatment Period
10986013|NCT00984659|FG002|Participant Flow|SAL 50 mcg: Double-blind Treatment Period|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
10986014|NCT00984659|FG003|Participant Flow|FSC 250/50 mcg: Double-blind Treatment Period|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
10986015|NCT00984659|OG000|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
10986016|NCT00984659|OG000|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
10986017|NCT00984659|EG000|Reported Event|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
10986018|NCT00984659|EG001|Reported Event|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
10986019|NCT00984659|EG002|Reported Event|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
10986020|NCT00984698|BG000|Baseline|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
10986021|NCT00984698|BG001|Baseline|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
10986022|NCT00984698|BG002|Baseline|Total|Total of all reporting groups
10986023|NCT00984698|FG000|Participant Flow|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
10846412|NCT00275821|FG000|Participant Flow|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10986024|NCT00984698|FG001|Participant Flow|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
10986025|NCT00984698|OG000|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
10986026|NCT00984698|OG001|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
10986027|NCT00984698|EG000|Reported Event|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
10986028|NCT00984698|EG001|Reported Event|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
10986029|NCT00984815|BG000|Baseline|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
10986030|NCT00984815|FG000|Participant Flow|HZT-501|Open-label treatment with HZT-501(ibuprofen 800 mg/famotidine 26.6 mg) tablets. All doses of study drug will be self-administered orally 3 times daily (TID), for up to 54 weeks.
10986031|NCT00984815|OG000|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
10986032|NCT00984815|EG000|Reported Event|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
10986033|NCT00984867|BG000|Baseline|Placebo|Placebo plus sitagliptin alone or in combination with metformin
10986034|NCT00984867|BG001|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
10986035|NCT00984867|BG002|Baseline|Total|Total of all reporting groups
10986036|NCT00984867|FG000|Participant Flow|Placebo|Placebo plus sitagliptin alone or in combination with metformin
10986037|NCT00984867|FG001|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
10986038|NCT00984867|OG000|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin
10986039|NCT00984867|OG001|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
10986040|NCT00984867|OG000|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
10986041|NCT00984867|OG001|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
10986042|NCT00984867|EG000|Reported Event|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.
10986043|NCT00984867|EG001|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.
10986044|NCT00985010|BG000|Baseline|Females|Brain death
10986045|NCT00985010|BG001|Baseline|Males|Brain death
10986046|NCT00985010|BG002|Baseline|Total|Total of all reporting groups
10986047|NCT00985010|FG000|Participant Flow|Females|Brain death
10986048|NCT00985010|FG001|Participant Flow|Males|Brain death
10986049|NCT00985010|OG000|Outcome|Females|Brain death
10986050|NCT00985010|OG001|Outcome|Males|Brain death
10986051|NCT00985010|EG000|Reported Event|Females|Brain death
10986052|NCT00985010|EG001|Reported Event|Males|Brain death
10986053|NCT00985088|BG000|Baseline|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986054|NCT00985088|BG001|Baseline|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986055|NCT00985088|BG002|Baseline|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986056|NCT00985088|BG003|Baseline|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986057|NCT00985088|BG004|Baseline|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986058|NCT00985088|BG005|Baseline|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986059|NCT00985088|BG006|Baseline|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
10986060|NCT00985088|BG007|Baseline|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986061|NCT00985088|BG008|Baseline|Total|Total of all reporting groups
10986062|NCT00985088|FG000|Participant Flow|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986063|NCT00985088|FG001|Participant Flow|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986064|NCT00985088|FG002|Participant Flow|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
11348165|NCT04207840|EG000|Reported Event|Primatene Mist, E004|"Participants who dosed with Primatene Mist.~Epinephrine (0.125 mg/inhalation): Participants will self-administer 2 inhalations of Epinephrine (0.125 mg/inhalation) for a total dosage of 0.25 mg."
10986065|NCT00985088|FG003|Participant Flow|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986066|NCT00985088|FG004|Participant Flow|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986067|NCT00985088|FG005|Participant Flow|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986068|NCT00985088|FG006|Participant Flow|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
10986069|NCT00985088|FG007|Participant Flow|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986070|NCT00985088|OG000|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
10986071|NCT00985088|OG001|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
10986072|NCT00985088|OG000|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986073|NCT00985088|OG001|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986074|NCT00985088|OG002|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986075|NCT00985088|OG003|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986076|NCT00985088|OG004|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986077|NCT00985088|OG005|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986078|NCT00985088|OG006|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
10986079|NCT00985088|OG007|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986080|NCT00985088|OG001|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986081|NCT00985088|OG001|Outcome|GSK2340273A F2 Group|Pooled group comprising the subjects from GSK2340273A F2_1D Group and GSK2340273A F2_2D Group.
10986082|NCT00985088|OG001|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986083|NCT00985088|OG000|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_2D Group and GSK2340274A F2_1D Group.
10986084|NCT00985088|OG000|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
10986085|NCT00985088|OG001|Outcome|GSK2340273A F2 Group|Pooled group comprising the subjects from GSK2340273A F2_2D Group and GSK2340273A F2_1D Group.
10986086|NCT00985088|OG001|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986087|NCT00985088|OG000|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
10986088|NCT00985088|EG000|Reported Event|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986089|NCT00985088|EG001|Reported Event|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986090|NCT00985088|EG002|Reported Event|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986091|NCT00985088|EG003|Reported Event|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986092|NCT00985088|EG004|Reported Event|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986093|NCT00985088|EG005|Reported Event|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986094|NCT00985088|EG006|Reported Event|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
10986095|NCT00985088|EG007|Reported Event|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
10986096|NCT00985114|BG000|Baseline|Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
10986097|NCT00985114|BG001|Baseline|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
10986098|NCT00985114|BG002|Baseline|Total|Total of all reporting groups
10986099|NCT00985114|FG000|Participant Flow|EndoBarrier Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
10986100|NCT00985114|FG001|Participant Flow|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
10986101|NCT00985114|OG000|Outcome|Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
10986102|NCT00985114|OG001|Outcome|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
10986103|NCT00985114|EG000|Reported Event|Device and Cross Over|"EndoBarrier~EndoBarrier: EndoBarrier implant"
10986104|NCT00985114|EG001|Reported Event|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
10986105|NCT00985140|BG000|Baseline|12 Gy TSEBT|"Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional boost treatment not to exceed 12 Gy."
10986106|NCT00985140|FG000|Participant Flow|12 Gy TSEBT|"Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional boost treatment not to exceed 12 Gy. ."
10986107|NCT00985140|OG000|Outcome|12 Gy TSEBT|"Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional boost treatment not to exceed 12 Gy. ."
10986108|NCT00985140|EG000|Reported Event|12 Gy TSEBT|"Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional boost treatment not to exceed 12 Gy. ."
10986109|NCT00985153|BG000|Baseline|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
10986110|NCT00985153|BG001|Baseline|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
10986111|NCT00985153|BG002|Baseline|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
10986112|NCT00985153|BG003|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
10986113|NCT00985153|BG004|Baseline|Total|Total of all reporting groups
10986114|NCT00985153|FG000|Participant Flow|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
10986115|NCT00985153|FG001|Participant Flow|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
10986116|NCT00985153|FG002|Participant Flow|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
10986117|NCT00985153|FG003|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
10986118|NCT00985153|OG000|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
10986119|NCT00985153|OG001|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
10986120|NCT00985153|OG002|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
10986121|NCT00985153|OG003|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
10986122|NCT00985153|EG000|Reported Event|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
10986123|NCT00985153|EG001|Reported Event|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
10986124|NCT00985153|EG002|Reported Event|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
10986125|NCT00985153|EG003|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
10986126|NCT00985166|BG000|Baseline|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
10986127|NCT00985166|BG001|Baseline|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
10986128|NCT00985166|BG002|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
10986129|NCT00985166|BG003|Baseline|Total|Total of all reporting groups
10986130|NCT00985166|FG000|Participant Flow|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
10986131|NCT00985166|FG001|Participant Flow|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
10986132|NCT00985166|FG002|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
10986133|NCT00985166|OG000|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
10986134|NCT00985166|OG001|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
10986135|NCT00985166|OG001|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
10986136|NCT00985166|OG002|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
10986137|NCT00985166|OG002|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1
10986138|NCT00985166|EG000|Reported Event|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
10986139|NCT00985166|EG001|Reported Event|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
10986140|NCT00985166|EG002|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
10986141|NCT00985192|BG000|Baseline|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
10986142|NCT00985192|FG000|Participant Flow|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
10986143|NCT00985192|OG000|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
10986144|NCT00985192|EG000|Reported Event|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
10986145|NCT00985231|BG000|Baseline|PureVision Multi-Focal Contact Lenses|
10986146|NCT00985231|BG001|Baseline|SofLens59 Contact Lens|
10986147|NCT00985231|BG002|Baseline|Total|Total of all reporting groups
10986148|NCT00985231|FG000|Participant Flow|PureVision Multi-Focal Contact Lenses|
10986149|NCT00985231|FG001|Participant Flow|SofLens59 Contact Lens|
10986150|NCT00985231|OG000|Outcome|PureVision Multi-Focal Contact Lenses|
10986151|NCT00985231|OG001|Outcome|SofLens59 Contact Lens|
10986152|NCT00985231|EG000|Reported Event|PureVision Multi-Focal Contact Lenses|
10986153|NCT00985231|EG001|Reported Event|SofLens59 Contact Lens|
10986154|NCT00985257|BG000|Baseline|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
10986155|NCT00985257|FG000|Participant Flow|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
10986156|NCT00985257|OG000|Outcome|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
10986157|NCT00985257|EG000|Reported Event|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
10986158|NCT00985426|BG000|Baseline|HEPLISAV-B|"Participants randomized to the HEPLISAV-B group received 0.5 mL HEPLISAV-B and 0.5 mL Placebo (saline) via intramuscular (IM) injections at Weeks 0, 4, and 24.~Participants also received two 0.5-mL IM injections of Placebo (saline) at Week 8."
10846413|NCT00275821|FG001|Participant Flow|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10986159|NCT00985426|BG001|Baseline|Engerix-B|Participants randomized to the Engerix-B group received two 1.0-mL IM injections of Engerix-B at Weeks 0, 4, 8, and 24.
10986160|NCT00985426|BG002|Baseline|Total|Total of all reporting groups
10986161|NCT00985426|FG000|Participant Flow|HEPLISAV-B|"To mimic the Engerix dosing regimen and to maintain the blind, subjects randomized to the HEPLISAV group received 0.5 mL HEPLISAV and 0.5 mL Placebo (saline) via intramuscular (IM) injections at Weeks 0, 4, and 24.~To mimic the Engerix dosing regimen and to maintain the blind, subjects also received two 0.5-mL IM injections of Placebo (saline) at Week 8."
10986162|NCT00985426|FG001|Participant Flow|Engerix-B|Subjects randomized to the Engerix-B group received two 1.0-mL IM injections of Engerix-B at Weeks 0, 4, 8, and 24.
10986163|NCT00985426|OG000|Outcome|HEPLISAV-B|"Participants randomized to the HEPLISAV-B group received 0.5 mL HEPLISAV-B and 0.5 mL Placebo (saline) via intramuscular (IM) injections at Weeks 0, 4, and 24.~Participants also received two 0.5-mL IM injections of Placebo (saline) at Week 8."
10986164|NCT00985426|OG001|Outcome|Engerix-B|Participants randomized to the Engerix-B group received two 1.0-mL IM injections of Engerix-B at Weeks 0, 4, 8, and 24.
10986165|NCT00985426|EG000|Reported Event|HEPLISAV-B|"Participants randomized to the HEPLISAV-B group received 0.5 mL HEPLISAV-B and 0.5 mL Placebo (saline) via intramuscular (IM) injections at Weeks 0, 4, and 24.~Participants also received two 0.5-mL IM injections of Placebo (saline) at Week 8."
10986166|NCT00985426|EG001|Reported Event|Engerix-B|Participants randomized to the Engerix-B group received two 1.0-mL IM injections of Engerix-B at Weeks 0, 4, 8, and 24.
10986167|NCT00985439|BG000|Baseline|Diclofenac Test (Lower Dose)|
10986168|NCT00985439|BG001|Baseline|Diclofenac Test (Upper Dose)|
10986169|NCT00985439|BG002|Baseline|Celecoxib 400 mg|
10986170|NCT00985439|BG003|Baseline|Placebo|
10986171|NCT00985439|BG004|Baseline|Total|Total of all reporting groups
10986172|NCT00985439|FG000|Participant Flow|Diclofenac Test (Lower Dose)|
10986173|NCT00985439|FG001|Participant Flow|Diclofenac Test (Upper Dose)|
10986174|NCT00985439|FG002|Participant Flow|Celecoxib 400 mg|
10986175|NCT00985439|FG003|Participant Flow|Placebo|
10986176|NCT00985439|OG000|Outcome|Diclofenac Test (Lower Dose)|18-mg
10986177|NCT00985439|OG001|Outcome|Diclofenac Test (Upper Dose)|35-mg
10986178|NCT00985439|OG002|Outcome|Celecoxib 400 mg|
10986179|NCT00985439|OG003|Outcome|Placebo|
10986180|NCT00985439|EG000|Reported Event|Diclofenac Test (Lower Dose)|
10986181|NCT00985439|EG001|Reported Event|Diclofenac Test (Upper Dose)|
10986182|NCT00985439|EG002|Reported Event|Celecoxib 400 mg|
10986183|NCT00985439|EG003|Reported Event|Placebo|
10986184|NCT00985465|BG000|Baseline|Synflorix Primed Group|Subjects who were previously primed with the Synflorix™ vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0).
10986185|NCT00985465|BG001|Baseline|Synflorix Unprimed Group|Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).
10986186|NCT00985465|BG002|Baseline|Total|Total of all reporting groups
10986187|NCT00985465|FG000|Participant Flow|Synflorix Primed Group|Subjects who were previously primed with the Synflorix™ vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0).
10986188|NCT00985465|FG001|Participant Flow|Synflorix Unprimed Group|Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).
10986189|NCT00985465|OG000|Outcome|Synflorix Primed Group|Subjects who were previously primed with the Synflorix™ vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0).
10986190|NCT00985465|OG000|Outcome|Synflorix Unprimed Group|Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).
10986191|NCT00985465|OG001|Outcome|Synflorix Unprimed Group|Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).
10986192|NCT00985465|EG000|Reported Event|Synflorix Primed Group|Subjects who were previously primed with the Synflorix™ vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0).
10986193|NCT00985465|EG001|Reported Event|Synflorix Unprimed Group|Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).
10986194|NCT00985491|BG000|Baseline|EndoBarrier Liner Device|"46 subjects were enrolled. 3 subjects were implant failures. 43 Subjects received the device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
10986195|NCT00985491|FG000|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
10986196|NCT00985491|OG000|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
10986197|NCT00985491|OG000|Outcome|Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
10986198|NCT00985491|EG000|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
11336372|NCT03565315|EG003|Reported Event|Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
10986199|NCT00985504|BG000|Baseline|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
10986200|NCT00985504|BG001|Baseline|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
10986201|NCT00985504|BG002|Baseline|Total|Total of all reporting groups
10986202|NCT00985504|FG000|Participant Flow|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
10986203|NCT00985504|FG001|Participant Flow|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
10986204|NCT00985504|OG000|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
10986205|NCT00985504|OG001|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
10986206|NCT00985504|EG000|Reported Event|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
10986207|NCT00985504|EG001|Reported Event|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
10986208|NCT00985517|BG000|Baseline|Phase 1: Cohort 1|CERE-120 at 9.4 x 10^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986209|NCT00985517|BG001|Baseline|Phase 1: Cohort 2|CERE-120 at 2.4 x 10^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986210|NCT00985517|BG002|Baseline|Phase 2: CERE-120|CERE-120 at 2.4 x 10^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986211|NCT00985517|BG003|Baseline|Phase 2: Sham Surgery|Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injections are performed during sham surgery.
10986212|NCT00985517|BG004|Baseline|Total|Total of all reporting groups
10986213|NCT00985517|FG000|Participant Flow|Phase 1: Cohort 1|CERE-120 at 9.4 x 10^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986214|NCT00985517|FG001|Participant Flow|Phase 1: Cohort 2|CERE-120 at 2.4 x 10^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986215|NCT00985517|FG002|Participant Flow|Phase 2: CERE-120 Treatment Group|CERE-120 at 2.4 x 10^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986216|NCT00985517|FG003|Participant Flow|Phase 2: Sham Surgery|Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injections are performed during sham surgery.
10986217|NCT00985517|OG000|Outcome|Phase 1: Cohort 1|CERE-120 at 9.4 x 10^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986218|NCT00985517|OG001|Outcome|Phase 1: Cohort 2|CERE-120 at 2.4 x 10^12, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986219|NCT00985517|OG002|Outcome|Phase 2: CERE-120|CERE-120 at 2.4 x 10^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986220|NCT00985517|OG003|Outcome|Phase 2: Sham Surgery|Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injections are performed during sham surgery.
10986221|NCT00985517|OG001|Outcome|Phase 1: Cohort 2|CERE-120 at 2.4 x 10^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986222|NCT00985517|EG000|Reported Event|Phase 1: Cohort 1|CERE-120 at 9.4 x 10^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986223|NCT00985517|EG001|Reported Event|Phase 1: Cohort 2|CERE-120 at 2.4 x 10^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986224|NCT00985517|EG002|Reported Event|Phase 2: CERE-120 Treatment Group|CERE-120 at 2.4 x 10^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
10986225|NCT00985517|EG003|Reported Event|Phase 2: Sham Surgery Control Group|Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injuections are performed during sham surgery.
10986226|NCT00985543|BG000|Baseline|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
10986227|NCT00985543|FG000|Participant Flow|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
10986228|NCT00985543|OG000|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
10986229|NCT00985543|OG001|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
10986230|NCT00985543|OG002|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
10986231|NCT00985543|EG000|Reported Event|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
10986232|NCT00985621|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.
10986233|NCT00985621|BG001|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986234|NCT00985621|BG002|Baseline|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986235|NCT00985621|BG003|Baseline|Oxycodone CR|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
10986236|NCT00985621|BG004|Baseline|Total|Total of all reporting groups
10986237|NCT00985621|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.
10986238|NCT00985621|FG001|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986239|NCT00985621|FG002|Participant Flow|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986240|NCT00985621|FG003|Participant Flow|Oxycodone CR|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
10986241|NCT00985621|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.
10986242|NCT00985621|OG001|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986243|NCT00985621|OG002|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986244|NCT00985621|OG003|Outcome|Oxycodone CR|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
10986245|NCT00985621|OG000|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986246|NCT00985621|OG001|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986247|NCT00985621|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.
10986248|NCT00985621|EG001|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986249|NCT00985621|EG002|Reported Event|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
10986250|NCT00985621|EG003|Reported Event|Oxycodone CR|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
10986251|NCT00985673|BG000|Baseline|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986252|NCT00985673|BG001|Baseline|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986253|NCT00985673|BG002|Baseline|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986254|NCT00985673|BG003|Baseline|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986255|NCT00985673|BG004|Baseline|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986256|NCT00985673|BG005|Baseline|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986257|NCT00985673|BG006|Baseline|Total|Total of all reporting groups
10986258|NCT00985673|FG000|Participant Flow|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986259|NCT00985673|FG001|Participant Flow|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986260|NCT00985673|FG002|Participant Flow|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986261|NCT00985673|FG003|Participant Flow|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986262|NCT00985673|FG004|Participant Flow|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986263|NCT00985673|FG005|Participant Flow|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986264|NCT00985673|OG000|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986265|NCT00985673|OG001|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986266|NCT00985673|OG002|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986267|NCT00985673|OG003|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986268|NCT00985673|OG004|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986269|NCT00985673|OG005|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986270|NCT00985673|OG006|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986271|NCT00985673|EG000|Reported Event|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986272|NCT00985673|EG001|Reported Event|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986273|NCT00985673|EG002|Reported Event|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986274|NCT00985673|EG003|Reported Event|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10846414|NCT00275821|FG002|Participant Flow|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10986275|NCT00985673|EG004|Reported Event|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986276|NCT00985673|EG005|Reported Event|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
10986277|NCT00985686|BG000|Baseline|Study Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the study arm.
10986278|NCT00985686|BG001|Baseline|Study Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the study arm.
10986279|NCT00985686|BG002|Baseline|Waitlist Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the waitlist arm.
10986280|NCT00985686|BG003|Baseline|Waitlist Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the waitlist arm.
10986281|NCT00985686|BG004|Baseline|Total|Total of all reporting groups
10986282|NCT00985686|FG000|Participant Flow|Study Arm, Younger Subgroup|"Arm where younger participants (13 to 18 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
10986283|NCT00985686|FG001|Participant Flow|Study Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
10986284|NCT00985686|FG002|Participant Flow|Waitlist Arm, Younger Subgroup|"Arm where younger participants (13-18 years of age) received the LEAP Project intervention after an 8 week wait period.~At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
10986285|NCT00985686|FG003|Participant Flow|Waitlist Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) received the LEAP Project intervention after an 8 week wait period.~At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
10986286|NCT00985686|OG000|Outcome|Younger Subgroup (13-18 Years of Age)|Subgroup of participants 13-18 years of age. Participants were randomized into the Study and Waitlist Arms.
10986287|NCT00985686|OG000|Outcome|Older Subgroup (19-24 Years of Age)|Subgroup of participants 19-24 years of age. Participants were randomized into the Study and Waitlist Arms.
10986288|NCT00985686|EG000|Reported Event|Study Arm, Younger Subgroup|Participants 13-18 years of age randomized into the study group
10986289|NCT00985686|EG001|Reported Event|Study Arm, Older Subgroup|Participants 19-24 years of age randomized into the study group
10986290|NCT00985686|EG002|Reported Event|Waitlist Arm, Younger Subgroup|Participants 13-18 years of age randomized into the waitlist group
10986291|NCT00985686|EG003|Reported Event|Waitlist Arm, Older Subgroup|Participants 19-24 years of age randomized into the wait list group
10846415|NCT00275821|OG000|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10986292|NCT00985712|BG000|Baseline|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
10986293|NCT00985712|BG001|Baseline|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
10986294|NCT00985712|BG002|Baseline|Total|Total of all reporting groups
10986295|NCT00985712|FG000|Participant Flow|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
10986296|NCT00985712|FG001|Participant Flow|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
10986297|NCT00985712|OG000|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
10986298|NCT00985712|OG001|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
10986299|NCT00985712|EG000|Reported Event|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
10986300|NCT00985712|EG001|Reported Event|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
10986301|NCT00985725|BG000|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
10986302|NCT00985725|BG001|Baseline|Placebo|Administered orally once-daily for 9 weeks.
10986303|NCT00985725|BG002|Baseline|Total|Total of all reporting groups
10986304|NCT00985725|FG000|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
10986305|NCT00985725|FG001|Participant Flow|Placebo|Administered orally once-daily for 9 weeks.
10986306|NCT00985725|OG000|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
10986307|NCT00985725|OG001|Outcome|Placebo|Administered orally once-daily for 9 weeks.
10986308|NCT00985725|EG000|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
10986309|NCT00985725|EG001|Reported Event|Placebo|Administered orally once-daily for 9 weeks.
10986310|NCT00985751|BG000|Baseline|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986311|NCT00985751|BG001|Baseline|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986312|NCT00985751|BG002|Baseline|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986313|NCT00985751|BG003|Baseline|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986314|NCT00985751|BG004|Baseline|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986315|NCT00985751|BG005|Baseline|Total|Total of all reporting groups
10986316|NCT00985751|FG000|Participant Flow|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986317|NCT00985751|FG001|Participant Flow|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986318|NCT00985751|FG002|Participant Flow|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986319|NCT00985751|FG003|Participant Flow|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986320|NCT00985751|FG004|Participant Flow|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986321|NCT00985751|OG000|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986322|NCT00985751|OG001|Outcome|Synflorix/GSK 2189242A Group|This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
10986323|NCT00985751|OG001|Outcome|GSK 2189242A Group|This group included subjects from GSK 2189242A-LD and GSK 2189242A-HD groups for whom pooled analysis was conducted.
10986324|NCT00985751|OG000|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986325|NCT00985751|OG001|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986326|NCT00985751|OG002|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986327|NCT00985751|OG003|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986328|NCT00985751|OG004|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986329|NCT00985751|EG000|Reported Event|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986330|NCT00985751|EG001|Reported Event|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986331|NCT00985751|EG002|Reported Event|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986332|NCT00985751|EG003|Reported Event|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986333|NCT00985751|EG004|Reported Event|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
10986334|NCT00985790|BG000|Baseline|GSK2321138A Group|"Subjects aged between 18 and 47 months received the GSK2321138A. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm."
10986335|NCT00985790|BG001|Baseline|Fluarix Group|"Subjects aged between 18 and 47 months received the Fluarix™ vaccine. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm."
10986336|NCT00985790|BG002|Baseline|Total|Total of all reporting groups
10986337|NCT00985790|FG000|Participant Flow|GSK2321138A Group|"Subjects aged between 18 and 47 months received the GSK2321138A. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm."
10986338|NCT00985790|FG001|Participant Flow|Fluarix Group|"Subjects aged between 18 and 47 months received the Fluarix™ vaccine. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm."
10986339|NCT00985790|OG000|Outcome|GSK2321138A Group|"Subjects aged between 18 and 47 months received the GSK2321138A. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm."
10986340|NCT00985790|OG001|Outcome|Fluarix Group|"Subjects aged between 18 and 47 months received the Fluarix™ vaccine. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm."
10986341|NCT00985790|OG000|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
10986342|NCT00985790|OG001|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
10986343|NCT00985790|OG000|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
10986344|NCT00985790|OG001|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
10986345|NCT00985790|OG000|Outcome|GSK2321138A Group|"Subjects aged between 18 and 47 months received the GSK2321138A. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm."
10986346|NCT00985790|EG000|Reported Event|GSK2321138A Group|"Subjects aged between 18 and 47 months received the GSK2321138A. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm."
10986347|NCT00985790|EG001|Reported Event|Fluarix Group|"Subjects aged between 18 and 47 months received the Fluarix™ vaccine. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm."
10986348|NCT00985829|BG000|Baseline|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
10986349|NCT00985829|FG000|Participant Flow|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
10986350|NCT00985829|OG000|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
10986351|NCT00985829|OG000|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
10986352|NCT00985829|EG000|Reported Event|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
10986353|NCT00985907|BG000|Baseline|Doxil® + Melphalan + Velcade (DMV)|"Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d~Melphalan: IV over 30 min, Day 1 q28d~Velcade®: IV bolus, Day 1, 4, 8, 11 q28d~Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2~Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2~Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2~Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2"
10986354|NCT00985907|FG000|Participant Flow|Phase 1|"Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d~Melphalan: IV over 30 min, Day 1 q28d~Velcade®: IV bolus, Day 1, 4, 8, 11 q28d~Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2~Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2~Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2~Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2"
10986355|NCT00985907|OG000|Outcome|Doxil® + Melphalan + Velcade (DMV)|"Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d~Melphalan: IV over 30 min, Day 1 q28d~Velcade®: IV bolus, Day 1, 4, 8, 11 q28d~Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2~Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2~Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2~Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2"
10986356|NCT00985907|EG000|Reported Event|Phase 1 Doxil® + Melphalan + Velcade (DMV)|"Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d~Melphalan: IV over 30 min, Day 1 q28d~Velcade®: IV bolus, Day 1, 4, 8, 11 q28d~Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2~Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2~Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2~Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2"
10986357|NCT00985946|BG000|Baseline|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
10986358|NCT00985946|FG000|Participant Flow|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
10986359|NCT00985946|OG000|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
10986360|NCT00985946|EG000|Reported Event|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design. Fifteen patients were accrued, and 13 were evaluable for response. No responses were seen, but the stable disease rate was 100%. The median progression-free survival (PFS) was 9.9 months, and the median overall survival was 47.3 months. Fatigue (27%), thrombocytopenia (20%), diarrhea (13%), and nausea (13%) were the most common related grade 3 toxicities. There was one grade 4 thrombocytopenia (7%). These results did not meet the prespecified criteria to open the study to full accrual.
10986361|NCT00985959|BG000|Baseline|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986362|NCT00985959|BG001|Baseline|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986363|NCT00985959|BG002|Baseline|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
10986364|NCT00985959|BG003|Baseline|Total|Total of all reporting groups
10986365|NCT00985959|FG000|Participant Flow|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986366|NCT00985959|FG001|Participant Flow|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986367|NCT00985959|FG002|Participant Flow|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
10986368|NCT00985959|OG000|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986369|NCT00985959|OG001|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986370|NCT00985959|OG002|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986371|NCT00985959|OG003|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
10986372|NCT00985959|OG004|Outcome|Total|Participants from both Phase I and Phase II
10986373|NCT00985959|OG000|Outcome|Melphalan|Melphalan 9 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
10986374|NCT00985959|OG000|Outcome|Prednisolone|Prednisolone 60 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
10986375|NCT00985959|OG000|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
10846416|NCT00275821|OG001|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10986376|NCT00985959|EG000|Reported Event|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986377|NCT00985959|EG001|Reported Event|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986378|NCT00985959|EG002|Reported Event|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
10986379|NCT00985959|EG003|Reported Event|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
10986380|NCT00985985|BG000|Baseline|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally.
10986381|NCT00985985|BG001|Baseline|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally.
10986382|NCT00985985|BG002|Baseline|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
10986383|NCT00985985|BG003|Baseline|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
10986384|NCT00985985|BG004|Baseline|Total|Total of all reporting groups
10986385|NCT00985985|FG000|Participant Flow|Nicotine Lozenge 2 Milligram (mg) (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally. During week 1 to week 6,participants were recommended to take at least 9 lozenges per day, but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
10986386|NCT00985985|FG001|Participant Flow|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take atleast 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse
10986387|NCT00985985|FG002|Participant Flow|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
10986388|NCT00985985|FG003|Participant Flow|Placebo Lozenge (High Dependence Smoke|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
10986389|NCT00985985|OG000|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
10986390|NCT00985985|OG001|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
10986391|NCT00985985|OG002|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
10986392|NCT00985985|OG003|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
10986393|NCT00985985|OG003|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine, orally.
10986394|NCT00985985|OG000|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
10986395|NCT00985985|OG001|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine, orally.
10986396|NCT00985985|OG002|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
10986397|NCT00985985|OG003|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
10986398|NCT00985985|EG000|Reported Event|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received 2 mg of nicotine lozenge, orally.
10986399|NCT00985985|EG001|Reported Event|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
10986400|NCT00985985|EG002|Reported Event|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg of nicotine lozenge, orally.
10986401|NCT00985985|EG003|Reported Event|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
10986402|NCT00986102|BG000|Baseline|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
10986403|NCT00986102|BG001|Baseline|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
10986404|NCT00986102|BG002|Baseline|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
10986405|NCT00986102|BG003|Baseline|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
10986406|NCT00986102|BG004|Baseline|Total|Total of all reporting groups
10986407|NCT00986102|FG000|Participant Flow|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
10986408|NCT00986102|FG001|Participant Flow|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
10986409|NCT00986102|FG002|Participant Flow|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
10986410|NCT00986102|FG003|Participant Flow|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
10986411|NCT00986102|OG000|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
10986412|NCT00986102|OG001|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
10986413|NCT00986102|OG002|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
10986414|NCT00986102|OG003|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
10986415|NCT00986102|EG000|Reported Event|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
10986416|NCT00986102|EG001|Reported Event|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
10986417|NCT00986102|EG002|Reported Event|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
10986418|NCT00986102|EG003|Reported Event|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
10986419|NCT00986154|BG000|Baseline|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
10986420|NCT00986154|BG001|Baseline|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
10986421|NCT00986154|BG002|Baseline|Total|Total of all reporting groups
10986422|NCT00986154|FG000|Participant Flow|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
10986423|NCT00986154|FG001|Participant Flow|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
10986424|NCT00986154|OG000|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
10986425|NCT00986154|OG001|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
10986426|NCT00986154|EG000|Reported Event|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
10986427|NCT00986154|EG001|Reported Event|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
10986428|NCT00986180|BG000|Baseline|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
10986429|NCT00986180|BG001|Baseline|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
10986430|NCT00986180|BG002|Baseline|Total|Total of all reporting groups
10986431|NCT00986180|FG000|Participant Flow|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
10986432|NCT00986180|FG001|Participant Flow|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
10986433|NCT00986180|OG000|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
10986434|NCT00986180|OG001|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
10986435|NCT00986180|EG000|Reported Event|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
10986436|NCT00986180|EG001|Reported Event|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
10986437|NCT00986232|BG000|Baseline|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986438|NCT00986232|BG001|Baseline|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986439|NCT00986232|BG002|Baseline|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986440|NCT00986232|BG003|Baseline|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
10986441|NCT00986232|BG004|Baseline|Total|Total of all reporting groups
10986442|NCT00986232|FG000|Participant Flow|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986443|NCT00986232|FG001|Participant Flow|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986444|NCT00986232|FG002|Participant Flow|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986445|NCT00986232|FG003|Participant Flow|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
10986446|NCT00986232|OG000|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986447|NCT00986232|OG001|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986448|NCT00986232|OG002|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986449|NCT00986232|OG003|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986450|NCT00986232|OG004|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986451|NCT00986232|OG005|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986452|NCT00986232|OG006|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
10986453|NCT00986232|EG000|Reported Event|ProQuad (Low Dose) After Injection 1|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986454|NCT00986232|EG001|Reported Event|ProQuad (Middle Dose) After Injection 1|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986455|NCT00986232|EG002|Reported Event|ProQuad (High Dose) After Injection 1|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986456|NCT00986232|EG003|Reported Event|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
10986457|NCT00986232|EG004|Reported Event|ProQuad (Low Dose) After Injection 2|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986458|NCT00986232|EG005|Reported Event|ProQuad (Middle Dose) After Injection 2|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986459|NCT00986232|EG006|Reported Event|ProQuad (High Dose) After Injection 2|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
10986460|NCT00986245|BG000|Baseline|Entire Study Population|Includes groups randomized to receive once daily first and twice daily first.
10986461|NCT00986245|FG000|Participant Flow|Ropinirole PR-Once Daily First, Then Twice Daily|Ropinirole prolonged release(PR) once daily in first intervention period and twice daily in second intervention period (without washout period)
10986462|NCT00986245|FG001|Participant Flow|Ropinirole PR-Twice Daily First, Then Once Daily|Ropinirole prolonged release(PR) twice daily in first intervention period and once daily in second intervention period (without washout period)
10986463|NCT00986245|OG000|Outcome|Once-daily|Once-daily preferred group
10986464|NCT00986245|OG001|Outcome|Twice-daily|Twice-daily preferred group
10986465|NCT00986245|OG002|Outcome|No Preference|No preference group
10986466|NCT00986245|OG000|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
10986467|NCT00986245|OG001|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
10986468|NCT00986245|OG000|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
10986469|NCT00986245|OG001|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
10986470|NCT00986245|EG000|Reported Event|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
10986471|NCT00986245|EG001|Reported Event|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
11007254|NCT01090050|OG000|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
10986472|NCT00986258|BG000|Baseline|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.
10986473|NCT00986258|FG000|Participant Flow|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks.Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.
10986474|NCT00986258|OG000|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.
10986475|NCT00986258|OG000|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.
10986476|NCT00986258|OG000|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
10986477|NCT00986258|OG001|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
10986478|NCT00986258|OG002|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
10986479|NCT00986258|OG000|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
10986480|NCT00986258|OG001|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
10986481|NCT00986258|OG002|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
10986482|NCT00986258|OG000|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
10986483|NCT00986258|OG001|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
10986484|NCT00986258|OG002|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
10986485|NCT00986258|EG000|Reported Event|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
10986486|NCT00986349|BG000|Baseline|EndoBarrier Liner Device|EndoBarrier Liner: 52 week treatment of EndoBarrier Liner
11336373|NCT03565666|BG000|Baseline|All Study Participants|"36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Participants in the usual care arm (UC) will manage their diabetes with either multiple daily injections or continuous subcutaneous insulin infusion (pump therapy). All subjects will wear Dexcom G5 continuous glucose monitor (CGM) and half of all subjects will also wear a senseonics CGM.~Each arm is 7 days, no washout between arms"
10986487|NCT00986349|FG000|Participant Flow|EndoBarrier Liner Device|Enrolled Subjects
10986488|NCT00986349|OG000|Outcome|EndoBarrier Liner Device at Baseline|HbA1c %
10986489|NCT00986349|OG001|Outcome|EndoBarrier Liner Device at 3 Months|HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
10986490|NCT00986349|OG002|Outcome|EndoBarrier Liner Device % at 6 Months|HbA1c
10986491|NCT00986349|OG003|Outcome|EndoBarrier Liner Device % at 9 Months|HbA1c
10986492|NCT00986349|OG004|Outcome|EndoBarrier Liner Device % at 52 Weeks|HbA1c
10986493|NCT00986349|OG000|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjecst who completed 12 month implant duration
10986494|NCT00986349|OG001|Outcome|Decrease in Glucose-Lowering Meds|Subjects who completed 12-month implant duration
10986495|NCT00986349|OG002|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects who completed 12-month implant duration
10986496|NCT00986349|OG000|Outcome|EndoBarrier Liner Device|52 week treatment of EndoBarrier Liner
10986497|NCT00986349|OG000|Outcome|Diabetes|"Single Arm~EndoBarrier Liner: 52 week treatment of EnoBarrier Liner"
10986498|NCT00986349|EG000|Reported Event|EndoBarrier Liner Device|All subjects who had a device attempted to be implanted. N = 23
10986499|NCT00986362|BG000|Baseline|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
10986500|NCT00986362|BG001|Baseline|Placebo|Placebo : Placebo intravitreal injection
10986501|NCT00986362|BG002|Baseline|Total|Total of all reporting groups
10986502|NCT00986362|FG000|Participant Flow|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
10986503|NCT00986362|FG001|Participant Flow|Placebo|Placebo : Placebo intravitreal injection
10986504|NCT00986362|OG000|Outcome|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
10986505|NCT00986362|OG001|Outcome|Placebo|Placebo : Placebo intravitreal injection
10986506|NCT00986362|EG000|Reported Event|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
10986507|NCT00986362|EG001|Reported Event|Placebo|Placebo : Placebo intravitreal injection
10986508|NCT00986401|BG000|Baseline|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
10986509|NCT00986401|BG001|Baseline|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
10986510|NCT00986401|BG002|Baseline|Total|Total of all reporting groups
11348166|NCT04207840|EG001|Reported Event|Epinephrine Injection Auto-Injector (Generic of EpiPen)|"Participants who were dosed with an Epinephrine Injection Auto-Injector.~Epinephrine Injection Auto-Injector (0.3mg/0.3mL): Participants will receive an intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL). The 0.30 mL dose will be given perpendicularly as a single deep intramuscular injection into the anterolateral aspect of the thigh."
10986511|NCT00986401|FG000|Participant Flow|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
10986512|NCT00986401|FG001|Participant Flow|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
10986513|NCT00986401|OG000|Outcome|Glucophage®|Glucophage®
10986514|NCT00986401|OG001|Outcome|Glucophage® + Sanctura XR®|Glucophage® + Sanctura XR®
10986515|NCT00986401|OG000|Outcome|Sanctura XR®|Sanctura XR®
10986516|NCT00986401|OG001|Outcome|Sanctura XR® + Glucophage®|Sanctura XR® + Glucophage®
10986517|NCT00986401|EG000|Reported Event|Glucophage®|Glucophage®
10986518|NCT00986401|EG001|Reported Event|Sanctura XR®|Sanctura XR®
10986519|NCT00986401|EG002|Reported Event|Sanctura XR® in Combination With Glucophage®|Sanctura XR® in combination with Glucophage®
10986520|NCT00986427|BG000|Baseline|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
10986521|NCT00986427|BG001|Baseline|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
10986522|NCT00986427|BG002|Baseline|Total|Total of all reporting groups
10986523|NCT00986427|FG000|Participant Flow|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
10986524|NCT00986427|FG001|Participant Flow|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
10986525|NCT00986427|OG000|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
10986526|NCT00986427|OG001|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
10986527|NCT00986427|OG000|Outcome|Restasis® Arm Treated Nail|Restasis® Treated Nail
10986528|NCT00986427|OG001|Outcome|Restasis® Arm Untreated Nail|Restasis® Untreated Nail
10986529|NCT00986427|OG002|Outcome|Refresh® Dry Eye Treated Nail|Refresh® Dry Eye Therapy Treated Nail
10986530|NCT00986427|OG003|Outcome|Refresh® Dry Eye Untreated Nail|Refresh® Dry Eye Therapy Untreated Nail
10986531|NCT00986427|EG000|Reported Event|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
10986532|NCT00986427|EG001|Reported Event|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
10986533|NCT00986440|BG000|Baseline|CS-7017 0.5 mg|Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.
10986534|NCT00986440|BG001|Baseline|Placebo|Participants who were randomized to receive matching placebo.
10986535|NCT00986440|BG002|Baseline|Total|Total of all reporting groups
10846417|NCT00275821|OG002|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10846418|NCT00275821|EG000|Reported Event|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10846419|NCT00275821|EG001|Reported Event|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10846420|NCT00275821|EG002|Reported Event|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
10846421|NCT00275834|BG000|Baseline|Placebo|
10846422|NCT00275834|BG001|Baseline|Zonisamide 200 mg|
10846423|NCT00275834|BG002|Baseline|Zonisamide 400 mg|
10846424|NCT00275834|BG003|Baseline|Total|Total of all reporting groups
10846425|NCT00275834|FG000|Participant Flow|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
10846426|NCT00275834|FG001|Participant Flow|Zonisamide 200 mg|Dosing of matching placebo was identical.
10846427|NCT00275834|FG002|Participant Flow|Zonisamide 400 mg|
10846428|NCT00275834|OG000|Outcome|Placebo|
10846429|NCT00275834|OG001|Outcome|Zonisamide 200 mg|
10846430|NCT00275834|OG002|Outcome|Zonisamide 400 mg|
10846431|NCT00275834|OG000|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
10846432|NCT00275834|OG001|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
10846433|NCT00275834|EG000|Reported Event|Placebo|
10846434|NCT00275834|EG001|Reported Event|Zonisamide 200 mg|
10846435|NCT00275834|EG002|Reported Event|Zonisamide 400 mg|
10846436|NCT00276094|BG000|Baseline|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846437|NCT00276094|BG001|Baseline|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846438|NCT00276094|BG002|Baseline|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846439|NCT00276094|BG003|Baseline|Total|Total of all reporting groups
10846440|NCT00276094|FG000|Participant Flow|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846441|NCT00276094|FG001|Participant Flow|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846442|NCT00276094|FG002|Participant Flow|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846443|NCT00276094|OG000|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846444|NCT00276094|OG001|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10986536|NCT00986440|FG000|Participant Flow|CS-7017 0.5 mg|Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.
10986537|NCT00986440|FG001|Participant Flow|Placebo|Participants who were randomized to receive matching placebo.
10986538|NCT00986440|OG000|Outcome|CS-7017 0.5 mg|Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.
10986539|NCT00986440|OG001|Outcome|Placebo|Participants who were randomized to receive matching placebo.
10986540|NCT00986440|EG000|Reported Event|CS-7017 0.5 mg|Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.
10986541|NCT00986440|EG001|Reported Event|Placebo|Participants who were randomized to receive matching placebo.
10986542|NCT00986453|BG000|Baseline|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
10986543|NCT00986453|FG000|Participant Flow|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
10986544|NCT00986453|OG000|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
10986545|NCT00986453|OG001|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
10986546|NCT00986453|EG000|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
10986547|NCT00986453|EG001|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
10986548|NCT00986479|BG000|Baseline|AZD6765 (150 mg)/ Placebo|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
10986549|NCT00986479|BG001|Baseline|Placebo/AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
10986550|NCT00986479|BG002|Baseline|Total|Total of all reporting groups
10986551|NCT00986479|FG000|Participant Flow|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
10986552|NCT00986479|FG001|Participant Flow|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
10986553|NCT00986479|OG000|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
10986554|NCT00986479|OG001|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
10986555|NCT00986479|EG000|Reported Event|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
10986556|NCT00986479|EG001|Reported Event|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
10986557|NCT00986544|BG000|Baseline|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
10986558|NCT00986544|BG001|Baseline|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
10986559|NCT00986544|BG002|Baseline|Total|Total of all reporting groups
10986560|NCT00986544|FG000|Participant Flow|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
10986561|NCT00986544|FG001|Participant Flow|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
10986562|NCT00986544|OG000|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
10986563|NCT00986544|OG001|Outcome|Drain|Drain positioned in the subhepatic space after laparoscopic cholecystectomy
10986564|NCT00986544|OG001|Outcome|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
10986565|NCT00986544|EG000|Reported Event|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
10986566|NCT00986544|EG001|Reported Event|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
10986567|NCT00986570|BG000|Baseline|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
10986568|NCT00986570|FG000|Participant Flow|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
10986569|NCT00986570|OG000|Outcome|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
10986570|NCT00986570|EG000|Reported Event|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
10986571|NCT00986583|BG000|Baseline|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
10986572|NCT00986583|BG001|Baseline|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
10986573|NCT00986583|BG002|Baseline|Total|Total of all reporting groups
10986574|NCT00986583|FG000|Participant Flow|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
10986575|NCT00986583|FG001|Participant Flow|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
10986576|NCT00986583|OG000|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
10986577|NCT00986583|OG001|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
10986578|NCT00986583|OG000|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
10986579|NCT00986583|EG000|Reported Event|Statin Users|
10986580|NCT00986583|EG001|Reported Event|Nonstatin Users|
10986581|NCT00986674|BG000|Baseline|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
10986582|NCT00986674|BG001|Baseline|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
10986583|NCT00986674|BG002|Baseline|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
10986584|NCT00986674|BG003|Baseline|Total|Total of all reporting groups
10986585|NCT00986674|FG000|Participant Flow|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
10986586|NCT00986674|FG001|Participant Flow|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
10986587|NCT00986674|FG002|Participant Flow|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
10986588|NCT00986674|OG000|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
10986589|NCT00986674|OG001|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
10986590|NCT00986674|OG002|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
11348167|NCT04207840|EG002|Reported Event|Albuterol HFA|"Participants who dosed with Albuterol HFA.~Albuterol Sulfate (0.09 mg/inhalation): Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg."
10986591|NCT00986674|EG000|Reported Event|Arm I (Carboplatin, Paclitaxel, Cetuximab)|Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
10986592|NCT00986674|EG001|Reported Event|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
10986593|NCT00986674|EG002|Reported Event|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
10986594|NCT00986830|BG000|Baseline|Balloon Dilation|Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
10986595|NCT00986830|FG000|Participant Flow|Balloon Dilation|Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
10986596|NCT00986830|OG000|Outcome|Balloon Dilation|Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
10986597|NCT00986830|EG000|Reported Event|Balloon Dilation|Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
10986598|NCT00986856|BG000|Baseline|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
10986599|NCT00986856|BG001|Baseline|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
10986600|NCT00986856|BG002|Baseline|Total|Total of all reporting groups
10986601|NCT00986856|FG000|Participant Flow|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
10986602|NCT00986856|FG001|Participant Flow|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
10986603|NCT00986856|OG000|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
10986604|NCT00986856|OG001|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
10986605|NCT00986856|EG000|Reported Event|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
10986606|NCT00986856|EG001|Reported Event|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
10986607|NCT00986921|BG000|Baseline|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
10986608|NCT00986921|BG001|Baseline|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
10986609|NCT00986921|BG002|Baseline|Total|Total of all reporting groups
10986610|NCT00986921|FG000|Participant Flow|Standard Osmotic Dilator Insertion|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard surgical technique."
10986611|NCT00986921|FG001|Participant Flow|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following mifepristone, by standard surgical technique."
10986612|NCT00986921|OG000|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
10986613|NCT00986921|OG001|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used.~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
10986614|NCT00986921|OG000|Outcome|Standard Osmotic Dilators|Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
10986615|NCT00986921|OG001|Outcome|Mifepristone|Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
10986616|NCT00986921|OG001|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
10986617|NCT00986921|EG000|Reported Event|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
10986618|NCT00986921|EG001|Reported Event|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
10986619|NCT00986973|BG000|Baseline|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day KUVAN for four months.
10986620|NCT00986973|FG000|Participant Flow|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
10986621|NCT00986973|OG000|Outcome|Sapropterin (KUVAN) Therapy|All subjects received KUVAN at a dose of 20/mg/kg/day for four months. Blood Phe levels were measured drawn before therapy and 4 months after starting therapy.
10986622|NCT00986973|OG000|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
10986623|NCT00986973|EG000|Reported Event|Sapropterin (KUVAN) Therapy|All subjects will received KUVAN therapy 20 mg/kg/day for four months.
10986624|NCT00986986|BG000|Baseline|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
10986625|NCT00986986|BG001|Baseline|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
10986626|NCT00986986|BG002|Baseline|Total|Total of all reporting groups
10986627|NCT00986986|FG000|Participant Flow|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
10986628|NCT00986986|FG001|Participant Flow|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
10986629|NCT00986986|OG000|Outcome|Extended Release Niacin|HIV infected individuals receiving extended release niacin
10986630|NCT00986986|OG001|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
10986631|NCT00986986|OG000|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
10986632|NCT00986986|EG000|Reported Event|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
10986633|NCT00986986|EG001|Reported Event|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
10986634|NCT00987337|BG000|Baseline|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
10986635|NCT00987337|BG001|Baseline|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
10986636|NCT00987337|BG002|Baseline|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
10986637|NCT00987337|BG003|Baseline|Total|Total of all reporting groups
10986638|NCT00987337|FG000|Participant Flow|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 milligram (mg) tablet orally twice daily as blinded therapy along with pegylated interferon alpha-2a (pegIFN alpha-2a) 180 microgram (mcg) subcutaneously once weekly and ribavirin (RBV) 1000 milligram per day (mg/day) to participants weighing less than or equal to(<=) 75 kilogram (kg) or RBV 1200 mg/day to participants weighing greater than (>) 75 kg, orally in 2 divided doses up to Week 24. Participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) (HCV RNA <15 international units/milliliter [IU/mL]) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (greater than or equal to [>=] 15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75kg or RBV 1200 mg/day if participant weighed >75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
10986639|NCT00987337|FG001|Participant Flow|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
10875328|NCT00437281|OG015|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875329|NCT00437281|OG016|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875330|NCT00437281|OG017|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875331|NCT00437281|OG018|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875332|NCT00437281|OG019|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875333|NCT00437281|OG000|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875334|NCT00437281|OG004|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875335|NCT00437281|OG005|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875336|NCT00437281|OG006|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875337|NCT00437281|OG007|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875338|NCT00437281|OG008|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875339|NCT00437281|OG009|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875340|NCT00437281|OG010|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875341|NCT00437281|OG011|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875342|NCT00437281|OG012|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875343|NCT00437281|OG013|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875344|NCT00437281|OG014|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875345|NCT00437281|OG015|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875346|NCT00437281|OG000|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875347|NCT00437281|OG001|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875348|NCT00437281|OG002|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875349|NCT00437281|OG003|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875350|NCT00437281|OG004|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875351|NCT00437281|OG005|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875352|NCT00437281|OG006|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875353|NCT00437281|OG007|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875354|NCT00437281|OG008|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875355|NCT00437281|OG009|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875356|NCT00437281|OG010|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875357|NCT00437281|OG011|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875358|NCT00437281|OG012|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875359|NCT00437281|OG013|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
11348168|NCT04206800|BG000|Baseline|Routine Care|Routine care is normally having men abstain from ejaculation from 2 to 5 days prior to the scheduled oocyte retrieval date. Men in the routine care arm will abstain from ejaculation greater than 48 hours before providing a semen sample the day of the scheduled oocyte retrieval.
10986640|NCT00987337|FG002|Participant Flow|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
10986641|NCT00987337|OG000|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
10986642|NCT00987337|OG001|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
10986643|NCT00987337|OG002|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
10986644|NCT00987337|OG000|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
10986645|NCT00987337|OG001|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
10986646|NCT00987337|EG000|Reported Event|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
10986647|NCT00987337|EG001|Reported Event|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
10986648|NCT00987337|EG002|Reported Event|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
10986649|NCT00987389|BG000|Baseline|Plasma Exchange|Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute.
10986650|NCT00987389|BG001|Baseline|No Plasma Exchange|Participants in this arm do not undergo plasma exchange.
10986651|NCT00987389|BG002|Baseline|Total|Total of all reporting groups
11348169|NCT04206800|BG001|Baseline|Ejaculatory Abstinence Less Than 24 Hours|"Males will ejaculate within 24 hours of the scheduled oocyte retrieval date.~Ejaculatory abstinence less than 24 hours: Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval"
11348170|NCT04206800|BG002|Baseline|Total|Total of all reporting groups
11348171|NCT04206800|FG000|Participant Flow|Routine Care|Routine care is normally having men abstain from ejaculation from 2 to 5 days prior to the scheduled oocyte retrieval date. Men in the routine care arm will abstain from ejaculation greater than 48 hours before providing a semen sample the day of the scheduled oocyte retrieval.
11348172|NCT04206800|FG001|Participant Flow|Ejaculatory Abstinence Less Than 24 Hours|"Males will ejaculate within 24 hours of the scheduled oocyte retrieval date.~Ejaculatory abstinence less than 24 hours: Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval"
10875360|NCT00437281|OG014|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875361|NCT00437281|OG015|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875362|NCT00437281|OG000|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875363|NCT00437281|EG000|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875364|NCT00437281|EG001|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875365|NCT00437281|EG002|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875366|NCT00437281|EG003|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875367|NCT00437281|EG004|Reported Event|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875368|NCT00437281|EG005|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875369|NCT00437281|EG006|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875370|NCT00437281|EG007|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875371|NCT00437281|EG008|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875372|NCT00437281|EG009|Reported Event|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875373|NCT00437281|EG010|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875374|NCT00437281|EG011|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10986652|NCT00987389|FG000|Participant Flow|Plasma Exchange With Standard Glucocorticoids|"Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute.~Glucocorticoids: During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then will follow a standard regimen."
10986653|NCT00987389|FG001|Participant Flow|Plasma Exchange With Reduced Glucocorticoids|"Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute.~Glucocorticoids: During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease to a reduced regimen."
10986654|NCT00987389|FG002|Participant Flow|No Plasma Exchange With Standard Glucocorticoids|"Participants in this arm do not undergo plasma exchange.~Glucocorticoids: During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then follow a standard regimen."
10986655|NCT00987389|FG003|Participant Flow|No Plasma Exchange With Reduced Glucocorticoid|"Participants in this arm do not undergo plasma exchange.~All subjects' received the same glucocorticoids dose for the first two weeks, then the dose was decreased following a reduced glucocorticoid dose regimen."
10986656|NCT00987389|OG000|Outcome|Plasma Exchange|"Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute.~Glucocorticoids: During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following either a standard regimen or a reduced regimen."
10986657|NCT00987389|OG001|Outcome|No Plasma Exchange|"Participants in this arm do not undergo plasma exchange~Glucocorticoids: During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following either a standard regimen or a reduced regimen."
10986658|NCT00987389|OG000|Outcome|Plasma Exchange|"Participants in this arm undergo plasma exchange and take take either a standard glucocorticoid dose or a reduced glucocorticoid dose.~Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute."
10986659|NCT00987389|OG001|Outcome|No Plasma Exchange|"Participants in this arm do not undergo plasma exchange and take either a standard glucocorticoid dose or a reduced glucocorticoid dose.~No Plasma Exchange: No plasma exchange."
10986660|NCT00987389|EG000|Reported Event|Plasma Exchange|Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute.
10986661|NCT00987389|EG001|Reported Event|No Plasma Exchange|Participants in this arm do not undergo plasma exchange
10986662|NCT00987402|BG000|Baseline|Plain Soap and Water|Surgical hand preparation with plain soap and water
10986663|NCT00987402|BG001|Baseline|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
10986664|NCT00987402|BG002|Baseline|Total|Total of all reporting groups
10986665|NCT00987402|FG000|Participant Flow|Plain Soap and Water|Surgical hand preparation with plain soap and water
10986666|NCT00987402|FG001|Participant Flow|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
10986667|NCT00987402|OG000|Outcome|Plain Soap and Water|Surgical hand preparation with plain soap and water
10986668|NCT00987402|OG001|Outcome|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
10986669|NCT00987402|EG000|Reported Event|Plain Soap and Water|Surgical hand preparation with plain soap and water
10986670|NCT00987402|EG001|Reported Event|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
10986671|NCT00987415|BG000|Baseline|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
10986672|NCT00987415|BG001|Baseline|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
10986673|NCT00987415|BG002|Baseline|Total|Total of all reporting groups
10986674|NCT00987415|FG000|Participant Flow|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
10986675|NCT00987415|FG001|Participant Flow|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
10986676|NCT00987415|OG000|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
10986677|NCT00987415|OG001|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
10986678|NCT00987415|EG000|Reported Event|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
10986679|NCT00987415|EG001|Reported Event|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
10846445|NCT00276094|OG002|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10986680|NCT00987467|BG000|Baseline|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
11336374|NCT03565666|FG000|Participant Flow|Usual Care Then Either iLet/Novolog/Humalog or iLet/Fiasp|Participants first started the usual care arm (managing their diabetes with either multiple daily injections or insulin pump) for 7 days, then switched to either the insulin-only iLet using Novolog or Humalog for 7 days, or the insulin-only iLet using Fiasp for 7 days. No washout period was required between arms
10846446|NCT00276094|EG000|Reported Event|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846447|NCT00276094|EG001|Reported Event|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846448|NCT00276094|EG002|Reported Event|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
10846449|NCT00276159|BG000|Baseline|852A Treatment|Patients receiving at least 12 doses of 852A.
10846450|NCT00276159|FG000|Participant Flow|852A Treatment|Patients receiving at least 12 doses of 852A.
10846451|NCT00276159|OG000|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
10846452|NCT00276159|EG000|Reported Event|852A Treatment|Patients receiving at least 12 doses of 852A.
10846453|NCT00276250|BG000|Baseline|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
10846454|NCT00276250|BG001|Baseline|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
10846455|NCT00276250|BG002|Baseline|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
10846456|NCT00276250|BG003|Baseline|Total|Total of all reporting groups
10846457|NCT00276250|FG000|Participant Flow|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
10846458|NCT00276250|FG001|Participant Flow|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
10846459|NCT00276250|FG002|Participant Flow|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
10846460|NCT00276250|OG000|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
10846461|NCT00276250|OG001|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
10846462|NCT00276250|OG002|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
10846463|NCT00276250|EG000|Reported Event|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
10846464|NCT00276250|EG001|Reported Event|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
10846465|NCT00276250|EG002|Reported Event|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
10846466|NCT00276380|BG000|Baseline|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
10986681|NCT00987467|FG000|Participant Flow|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
10986682|NCT00987467|OG000|Outcome|Patients With Steroid Resistant/ Dependant AKC.|Ten patients with significant AKC either steroid dependent or resistant who were having active inflammation were enrolled in this study.
10986683|NCT00987467|OG000|Outcome|Topical Steroid Resistant/Dependant AKC|Patients with topical steroid resistant or dependant AKC were used for this study.
10986684|NCT00987467|EG000|Reported Event|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
10986685|NCT00987480|BG000|Baseline|Chemotherapy-based Cytoreductive Regimen Plus a CD34+ Selected|"This phase II trial is designed to investigate the safety and efficacy of a chemotherapy-based cytoreductive regimen plus a CD34+ selected T-cell depleted peripheral blood stem cell (PBSC) stem cell transplant for the treatment of patients with Fanconi anemia and severe hematologic disease.~Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.: There are three parts in this transplant study. 1) There will be a pre-transplant - preparation - period to see if patient qualifies for the transplant study. This will be done as an outpatient and lasts 2-4 weeks. Once this is completed, there will be 2) the transplant period itself, during which the patient will be admitted and will be an inpatient. This period usually last for 4-6 weeks. Following that, there will be a 3) post transplant period, during which the patient will be watched carefully and monitored in clinic as an out patient. The post transplant period lasts from three months to one year."
10986686|NCT00987480|FG000|Participant Flow|Chemotherapy-based Cytoreductive Regimen Plus a CD34+ Selected|"This phase II trial is designed to investigate the safety and efficacy of a chemotherapy-based cytoreductive regimen plus a CD34+ selected T-cell depleted peripheral blood stem cell (PBSC) stem cell transplant for the treatment of patients with Fanconi anemia and severe hematologic disease.~Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.: There are three parts in this transplant study. 1) There will be a pre-transplant - preparation - period to see if patient qualifies for the transplant study. This will be done as an outpatient and lasts 2-4 weeks. Once this is completed, there will be 2) the transplant period itself, during which the patient will be admitted and will be an inpatient. This period usually last for 4-6 weeks. Following that, there will be a 3) post transplant period, during which the patient will be watched carefully and monitored in clinic as an out patient. The post transplant period lasts from three months to one year."
10986687|NCT00987480|OG000|Outcome|Chemotherapy-based Cytoreductive Regimen Plus a CD34+ Selected|"This phase II trial is designed to investigate the safety and efficacy of a chemotherapy-based cytoreductive regimen plus a CD34+ selected T-cell depleted peripheral blood stem cell (PBSC) stem cell transplant for the treatment of patients with Fanconi anemia and severe hematologic disease.~Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.: There are three parts in this transplant study. 1) There will be a pre-transplant - preparation - period to see if patient qualifies for the transplant study. This will be done as an outpatient and lasts 2-4 weeks. Once this is completed, there will be 2) the transplant period itself, during which the patient will be admitted and will be an inpatient. This period usually last for 4-6 weeks. Following that, there will be a 3) post transplant period, during which the patient will be watched carefully and monitored in clinic as an out patient. The post transplant period lasts from three months to one year."
10986688|NCT00987480|EG000|Reported Event|Chemotherapy-based Cytoreductive Regimen Plus a CD34+ Selected|This phase II trial is designed to investigate the safety and efficacy of a chemotherapy-based cytoreductive regimen plus a CD34+ selected T-cell depleted peripheral blood stem cell (PBSC) stem cell transplant for the treatment of patients with Fanconi anemia and severe hematologic disease
10986689|NCT00987558|BG000|Baseline|Eslicarbazepine Acetate + Simvastatin|"Simvastatin 80 mg + eslicarbazepine acetate 800 mg~Simvastatin + ESL: Oral single-dose of simvastatin 80 mg on two occasions - once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days - separated by a washout period of 3 weeks or more."
10986690|NCT00987558|FG000|Participant Flow|Simvastatin, Then ESL + Simvastatin|Simvastatin 80 mg - Oral single-dose administered alone Washout period - 3 weeks Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day
10986691|NCT00987558|FG001|Participant Flow|ESL, Then Simvastatin|Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day Washout period - 3 weeks Simvastatin 80 mg - Oral single-dose administered alone
10986692|NCT00987558|OG000|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
10986693|NCT00987558|OG001|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
10986694|NCT00987558|EG000|Reported Event|Simvastatin|Simvastatin 80 mg
10986695|NCT00987558|EG001|Reported Event|Eslicarbazepine Acetate|eslicarbazepine acetate 800 mg
10986696|NCT00987558|EG002|Reported Event|Eslicarbazepine Acetate + Simvastatin|Simvastatin 80 mg + eslicarbazepine acetate 800 mg
10986697|NCT00987623|BG000|Baseline|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
10986698|NCT00987623|BG001|Baseline|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
10986699|NCT00987623|BG002|Baseline|Total|Total of all reporting groups
10986700|NCT00987623|FG000|Participant Flow|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
10986701|NCT00987623|FG001|Participant Flow|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
10986702|NCT00987623|OG000|Outcome|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
10986703|NCT00987623|OG001|Outcome|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
10986704|NCT00987623|EG000|Reported Event|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
10986705|NCT00987623|EG001|Reported Event|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
10986706|NCT00987727|BG000|Baseline|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
10986707|NCT00987727|BG001|Baseline|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
10986708|NCT00987727|BG002|Baseline|Total|Total of all reporting groups
10986709|NCT00987727|FG000|Participant Flow|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
10986710|NCT00987727|FG001|Participant Flow|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
10986711|NCT00987727|OG000|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
10986712|NCT00987727|OG001|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
10986713|NCT00987727|EG000|Reported Event|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
10986714|NCT00987727|EG001|Reported Event|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
10986715|NCT00987831|BG000|Baseline|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppresion vs themselves serving as their own control flaring later....not on immune suppression.
10986716|NCT00987831|BG001|Baseline|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
10986717|NCT00987831|BG002|Baseline|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
10986718|NCT00987831|BG003|Baseline|Total|Total of all reporting groups
10986719|NCT00987831|FG000|Participant Flow|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
10986720|NCT00987831|FG001|Participant Flow|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
10986721|NCT00987831|FG002|Participant Flow|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
10986722|NCT00987831|OG000|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease activity is defined as > 3 BILAG B, OR at least one BILAG A or SLEDAI > 10 OR Meets Definition for severe Flare on SELENA SLEDAI
10986723|NCT00987831|OG001|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease activity is defined as up to 3 BILAG B, no A, and SLEDAI </= 10.
10875375|NCT00437281|EG012|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875376|NCT00437281|EG013|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875377|NCT00437281|EG014|Reported Event|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875378|NCT00437281|EG015|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875379|NCT00437281|EG016|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875380|NCT00437281|EG017|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875381|NCT00437281|EG018|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10875382|NCT00437281|EG019|Reported Event|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
10879416|NCT00457730|BG000|Baseline|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
10879417|NCT00457730|BG001|Baseline|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
10879418|NCT00457730|BG002|Baseline|Total|Total of all reporting groups
10879419|NCT00457730|FG000|Participant Flow|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
10879420|NCT00457730|FG001|Participant Flow|Placebo|subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
10986724|NCT00987831|OG000|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease is now defined as total cumulative BILAG score >/= 17
10879421|NCT00457730|OG000|Outcome|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
10879422|NCT00457730|OG001|Outcome|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
10879423|NCT00457730|OG000|Outcome|Duloxetine|ubjects will take 30 mg daily for 1 week, then 60 mg daily for 5 weeks, then titrate back down to 30 mg daily for 1 week.
10879424|NCT00457730|OG001|Outcome|Placebo|matched placebo medication throughout 6 week observation period
10879425|NCT00457730|OG000|Outcome|Duloxetine|Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week
10879426|NCT00457730|OG001|Outcome|Placebo|matched placebo medication with same periods
10879427|NCT00457730|EG000|Reported Event|Duloxetine|Study drug, Duloxetine, 30 mg for 1 week, titrate up to 60 mg for 5 weeks and titrate back down to 30 mg for 1 week.
10879428|NCT00457730|EG001|Reported Event|Placebo|Placebo: Matching placebo drug for 7 weeks total
10875383|NCT00437294|BG000|Baseline|Capecitabine + Enzastaurin|"Capecitabine: 1250 milligrams per square meter (mg/m^2), twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Enzastaurin: 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease."
10875384|NCT00437294|BG001|Baseline|Capecitabine + Placebo|"Capecitabine: 1250 mg/m^2, BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycles until progressive disease.~Placebo: taken as 4 tablets orally, tablets daily, to complete 21-day cycles until progressive disease."
10875385|NCT00437294|BG002|Baseline|Total|Total of all reporting groups
10875386|NCT00437294|FG000|Participant Flow|Capecitabine + Enzastaurin|"Capecitabine: 1250 milligrams per square meter (mg/m^2), twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Enzastaurin: 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease."
10875387|NCT00437294|FG001|Participant Flow|Capecitabine + Placebo|"Capecitabine: 1250 mg/m^2, BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Placebo: taken as 4 tablets orally, daily, to complete 21-day cycles until progressive disease."
10875388|NCT00437294|OG000|Outcome|Capecitabine + Enzastaurin|"Capecitabine: 1250 milligrams per square meter (mg/m^2), twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Enzastaurin: 1125 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease."
10875389|NCT00437294|OG001|Outcome|Capecitabine + Placebo|"Capecitabine: 1250 mg/m^2, BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Placebo: taken as 4 tablets orally, daily, to complete 21-day cycles until progressive disease."
10875390|NCT00437294|OG000|Outcome|Capecitabine + Enzastaurin|"Capecitabine: 1250 milligrams per square meter (mg/m^2) twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Enzastaurin: 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease."
10875391|NCT00437294|OG001|Outcome|Capecitabine + Placebo|"Capecitabine: 1250 mg/m^2 BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Placebo: 4 tablets orally, daily, to complete 21-day cycles until progressive disease."
10875392|NCT00437294|OG000|Outcome|Capecitabine + Enzastaurin|"Capecitabine: 1250 milligrams per square meter (mg/m^2), twice daily on Days 1-14 with a1 week rest period for 21-day cycles until progressive disease~Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 and 500 mg daily on following days to complete 21-day cycles until progressive disease"
10875393|NCT00437294|OG001|Outcome|Capecitabine + Placebo|"Capecitabine: 1250 mg/m^2, twice daily on Days 1-14 with a1 week rest period for 21-day cycles until progressive disease~Placebo: taken as 4 oral tablets daily to complete 21-day cycles until progressive disease"
10875394|NCT00437294|OG000|Outcome|Capecitabine + Enzastaurin|"Capecitabine: 1250 milligrams per square meter (mg/m^2), twice daily on Days 1-14 with a1-week rest period for 21-day cycles until progressive disease~Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 and 500 mg daily on following days to complete 21-day cycles until progressive disease"
10875395|NCT00437294|OG001|Outcome|Capecitabine + Placebo|"Capecitabine: 1250 mg/m^2 twice daily on Days 1-14 with a1-week rest period for 21-day cycles until progressive disease~Placebo: taken as 4 oral tablets daily to complete 21-day cycles until progressive disease"
10875396|NCT00437294|EG000|Reported Event|A - Capecitabine + Enzastaurin|"Capecitabine: 1250 milligrams per square meter (mg/m^2) twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Enzastaurin: 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease."
10875397|NCT00437294|EG001|Reported Event|B - Capecitabine + Placebo|"Capecitabine: 1250 mg/m^2 BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease.~Placebo: 4 tablets orally, daily, to complete 21-day cycles until progressive disease."
10875398|NCT00437489|BG000|Baseline|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
10875399|NCT00437489|BG001|Baseline|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
10875400|NCT00437489|BG002|Baseline|Total|Total of all reporting groups
10875401|NCT00437489|FG000|Participant Flow|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
10875402|NCT00437489|FG001|Participant Flow|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
10875403|NCT00437489|OG000|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
10875404|NCT00437489|OG001|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
10875405|NCT00437489|EG000|Reported Event|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
10875406|NCT00437489|EG001|Reported Event|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
10875407|NCT00437645|BG000|Baseline|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
10986725|NCT00987831|OG001|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease is now defined as BILAG < 17 in cumulative score
10875408|NCT00437645|BG001|Baseline|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
10875409|NCT00437645|BG002|Baseline|Total|Total of all reporting groups
10875410|NCT00437645|FG000|Participant Flow|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
10875411|NCT00437645|FG001|Participant Flow|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
10875412|NCT00437645|OG000|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
10875413|NCT00437645|OG001|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
10875414|NCT00437645|EG000|Reported Event|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
10875415|NCT00437645|EG001|Reported Event|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
10875416|NCT00437658|BG000|Baseline|Elagolix 150 mg QD|Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
10875417|NCT00437658|BG001|Baseline|Elagolix 75 mg BID|Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
10875418|NCT00437658|BG002|Baseline|DMPA-SC|Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.
10875419|NCT00437658|BG003|Baseline|Total|Total of all reporting groups
11336375|NCT03565666|FG001|Participant Flow|iLet/Novolog/Humalog Then Either iLet/Fiasp or Usual Care|Participants first started using the insulin-only iLet with either Novolog or Humalog for 7 days then switched to either the usual care arm (managing their diabetes with multiple daily injections or insulin pump) for 7 days, or the insulin-only iLet arm using Fiasp for 7 days. No washout period was required between arms.
10875420|NCT00437658|FG000|Participant Flow|Elagolix 150 mg QD|Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
10875421|NCT00437658|FG001|Participant Flow|Elagolix 75 mg BID|Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
10875422|NCT00437658|FG002|Participant Flow|DMPA-SC|Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.
10875423|NCT00437658|OG000|Outcome|Elagolix 150 mg QD|Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
10875424|NCT00437658|OG001|Outcome|Elagolix 75 mg BID|Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
10875425|NCT00437658|OG002|Outcome|DMPA-SC|Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.
10875426|NCT00437658|EG000|Reported Event|Elagolix 150 mg QD|Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
10875427|NCT00437658|EG001|Reported Event|Elagolix 75 mg BID|Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
11098994|NCT01579162|BG001|Baseline|Chronic HCV Patients With F0-F2 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
10875428|NCT00437658|EG002|Reported Event|DMPA-SC|Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.
10875429|NCT00437983|BG000|Baseline|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
10875430|NCT00437983|BG001|Baseline|Placebo|Cellulose tainted with fishy odor
10875431|NCT00437983|BG002|Baseline|Total|Total of all reporting groups
10875432|NCT00437983|FG000|Participant Flow|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
10875433|NCT00437983|FG001|Participant Flow|Placebo|Cellulose tainted with fishy odor
10875434|NCT00437983|OG000|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
10875435|NCT00437983|OG001|Outcome|Placebo|Cellulose tainted with fishy odor
10875436|NCT00437983|EG000|Reported Event|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
10875437|NCT00437983|EG001|Reported Event|Placebo|Cellulose tainted with fishy odor
10875438|NCT00438100|BG000|Baseline|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
10875439|NCT00438100|BG001|Baseline|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
10875440|NCT00438100|BG002|Baseline|Total|Total of all reporting groups
10875441|NCT00438100|FG000|Participant Flow|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
10875442|NCT00438100|FG001|Participant Flow|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
10875443|NCT00438100|OG000|Outcome|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
11098995|NCT01579162|BG002|Baseline|Chronic HCV Patients With F3-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
10875444|NCT00438100|OG001|Outcome|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
10875445|NCT00438100|EG000|Reported Event|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
10875446|NCT00438100|EG001|Reported Event|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
10875447|NCT00438191|BG000|Baseline|As-Desired Splinting|Subjects who wear the splint as desired
10875448|NCT00438191|BG001|Baseline|Full Time Splinting|Subjects who wear the splint as much as possible
10875449|NCT00438191|BG002|Baseline|Total|Total of all reporting groups
10875450|NCT00438191|FG000|Participant Flow|As-Desired Splinting|Subjects who wear the splint as desired
10875451|NCT00438191|FG001|Participant Flow|Full Time Splinting|Subjects who wear the splint as much as possible
10875452|NCT00438191|OG000|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
10875453|NCT00438191|OG001|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
10875454|NCT00438191|EG000|Reported Event|As-Desired Splinting|Subjects who wear the splint as desired
10875455|NCT00438191|EG001|Reported Event|Full Time Splinting|Subjects who wear the splint as much as possible
10875456|NCT00438204|BG000|Baseline|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
10875457|NCT00438204|FG000|Participant Flow|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
10875458|NCT00438204|OG000|Outcome|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
10986726|NCT00987831|EG000|Reported Event|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
10846467|NCT00276380|BG001|Baseline|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch"
10986727|NCT00987831|EG001|Reported Event|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
10986728|NCT00987831|EG002|Reported Event|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
10986729|NCT00987935|BG000|Baseline|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
10986730|NCT00987935|BG001|Baseline|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986731|NCT00987935|BG002|Baseline|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986732|NCT00987935|BG003|Baseline|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986733|NCT00987935|BG004|Baseline|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986734|NCT00987935|BG005|Baseline|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986735|NCT00987935|BG006|Baseline|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986736|NCT00987935|BG007|Baseline|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
10986737|NCT00987935|BG008|Baseline|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
10986738|NCT00987935|BG009|Baseline|Total|Total of all reporting groups
10986739|NCT00987935|FG000|Participant Flow|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
10986740|NCT00987935|FG001|Participant Flow|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986741|NCT00987935|FG002|Participant Flow|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986742|NCT00987935|FG003|Participant Flow|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986743|NCT00987935|FG004|Participant Flow|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986744|NCT00987935|FG005|Participant Flow|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986745|NCT00987935|FG006|Participant Flow|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986746|NCT00987935|FG007|Participant Flow|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
10875459|NCT00438204|OG000|Outcome|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed disodium every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed disodium 400 mg/m2 intravenously over 10 minutes every 14 days."
10875460|NCT00438204|EG000|Reported Event|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
10875461|NCT00438256|BG000|Baseline|Proton Beam Radiation/ Capecitabine|"Procedure/Surgery:~Proton Beam Radiation: Given over different schedules and duration~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875462|NCT00438256|FG000|Participant Flow|Proton Beam Radiation/ Capecitabine Dose Level 1|"Procedure/Surgery:~Proton Beam Radiation: Given over 10 Radiation Sessions over 2 weeks~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875463|NCT00438256|FG001|Participant Flow|Proton Beam Radiation/ Capecitabine Dose Level 2|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation sessions: 3 in week 1 and 2 in week 2~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875464|NCT00438256|FG002|Participant Flow|Proton Beam Radiation/ Capecitabine Dose Level 3|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation sessions: 4 in week 1 and 1 in week 2~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875465|NCT00438256|FG003|Participant Flow|Proton Beam Radiation/ Capecitabine Dose Level 4|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation Sessions in one week~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875466|NCT00438256|OG000|Outcome|Proton Beam Radiation/ Capecitabine|"Procedure/Surgery:~Proton Beam Radiation: 5 fractions over 5 consecutive days for a total of 25 Gray Equivalents (GyE)~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875467|NCT00438256|OG000|Outcome|Phase II: Proton Beam Radiation/ Capecitabine|"Procedure/Surgery:~Proton Beam Radiation: 5 fractions over 5 consecutive days for a total of 25 Gray Equivalents (GyE)~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875468|NCT00438256|OG000|Outcome|Proton Beam Radiation/ Capecitabine|"Procedure/Surgery:~Proton Beam Radiation: Given over different schedules and duration~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875469|NCT00438256|OG000|Outcome|Proton Beam Radiation/ Capecitabine Dose Level 1|"Procedure/Surgery:~Proton Beam Radiation: Given over 10 Radiation Sessions over 2 weeks~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875470|NCT00438256|OG001|Outcome|Proton Beam Radiation/ Capecitabine Dose Level 2|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation sessions: 3 in week 1 and 2 in week 2~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875471|NCT00438256|OG002|Outcome|Proton Beam Radiation/ Capecitabine Dose Level 3|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation sessions: 4 in week 1 and 1 in week 2~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875472|NCT00438256|OG003|Outcome|Proton Beam Radiation/ Capecitabine Dose Level 4|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation Sessions in one week~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875473|NCT00438256|EG000|Reported Event|Proton Beam Radiation/ Capecitabine Dose Level 1|"Procedure/Surgery:~Proton Beam Radiation: Given over 10 Radiation Sessions over 2 weeks~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875474|NCT00438256|EG001|Reported Event|Proton Beam Radiation/ Capecitabine Dose Level 2|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation sessions: 3 in week 1 and 2 in week 2~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875475|NCT00438256|EG002|Reported Event|Proton Beam Radiation/ Capecitabine Dose Level 3|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation sessions: 4 in week 1 and 1 in week 2~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875476|NCT00438256|EG003|Reported Event|Proton Beam Radiation/ Capecitabine Dose Level 4|"Procedure/Surgery:~Proton Beam Radiation: Given over 5 Radiation Sessions in one week~Drug:~Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks"
10875477|NCT00438360|BG000|Baseline|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
10875478|NCT00438360|BG001|Baseline|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
10875479|NCT00438360|BG002|Baseline|Total|Total of all reporting groups
10875480|NCT00438360|FG000|Participant Flow|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
10875481|NCT00438360|FG001|Participant Flow|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
10875482|NCT00438360|OG000|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
10875483|NCT00438360|OG001|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
10986747|NCT00987935|FG008|Participant Flow|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
10986748|NCT00987935|OG000|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
10986749|NCT00987935|OG001|Outcome|Group 2|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
10986750|NCT00987935|OG000|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
10986751|NCT00987935|OG001|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
10986752|NCT00987935|OG000|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
10986753|NCT00987935|OG001|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986754|NCT00987935|OG002|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986755|NCT00987935|OG003|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986756|NCT00987935|OG004|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986757|NCT00987935|OG005|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986758|NCT00987935|OG006|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
10986759|NCT00987935|OG007|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
10986760|NCT00987935|OG008|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
10986761|NCT00987935|OG000|Outcome|Phase I Group 1, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
10986762|NCT00987935|OG001|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
10986763|NCT00987935|EG000|Reported Event|Phase I Group I Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
10986764|NCT00987935|EG001|Reported Event|Phase I Group I Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
10986765|NCT00987935|EG002|Reported Event|Phase I Group I Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
10986766|NCT00987935|EG003|Reported Event|Phase I Group II Nintedanib, 50 mg Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
10986767|NCT00987935|EG004|Reported Event|Phase I Group II Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
10986768|NCT00987935|EG005|Reported Event|Phase I Group II Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
10986769|NCT00987935|EG006|Reported Event|Phase I Group II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
10986770|NCT00987935|EG007|Reported Event|Phase II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) during Phase II
10986771|NCT00987935|EG008|Reported Event|Phase II Sorafenib, 400 mg Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid) during Phase II
10986772|NCT00987948|BG000|Baseline|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
10986773|NCT00987948|FG000|Participant Flow|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
10986774|NCT00987948|OG000|Outcome|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
10986775|NCT00987948|EG000|Reported Event|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
10986776|NCT00988000|BG000|Baseline|Respond to Study Invitation - Agree to Alternative Consultatio|participants agreed to have an alternative consultation i.e. telephone consultation for their first hospital appointment
10846468|NCT00276380|BG002|Baseline|Total|Total of all reporting groups
10986777|NCT00988000|BG001|Baseline|Respond to Study Invitation - Declined/ Non-responders|Participants declined or did not respond to the invitation to participate in the study
10986778|NCT00988000|BG002|Baseline|Comparator - Choose and Book|participants in this group booked their appointment through the choose and book system
10986779|NCT00988000|BG003|Baseline|Total|Total of all reporting groups
10875484|NCT00438360|EG000|Reported Event|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
10875485|NCT00438360|EG001|Reported Event|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
10875486|NCT00438399|BG000|Baseline|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
10875487|NCT00438399|BG001|Baseline|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
10875488|NCT00438399|BG002|Baseline|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
10875489|NCT00438399|BG003|Baseline|Total|Total of all reporting groups
10875490|NCT00438399|FG000|Participant Flow|C. Propionate-Wash Out-Corticosteroid 1|Clobetasol propionate Shampoo first, then Corticosteroid 1
10875491|NCT00438399|FG001|Participant Flow|Corticosteroid 1-Wash Out-C. Propionate|Corticosteroid 1 first then Clobetasol propionate Shampoo
10875492|NCT00438399|FG002|Participant Flow|C. Propionate-Wash Out-Corticosteroid 2|Clobetasol propionate Shampoo first, then Corticosteroid 2
10875493|NCT00438399|FG003|Participant Flow|Corticosteroid 2-Wash Out-C. Propionate|Corticosteroid 2 first, then Clobetasol propionate shampoo
10875494|NCT00438399|FG004|Participant Flow|C. Propionate -Wash Out-Corticosteroid 3|Clobetasol propionate shampoo first then Corticosteroid 3
10875495|NCT00438399|FG005|Participant Flow|Corticosteroid 3-Wash Out-C. Propionate|Corticosteroid 3 first, then Clobetasol propionate
10875496|NCT00438399|OG000|Outcome|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
10875497|NCT00438399|OG001|Outcome|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
10875498|NCT00438399|OG002|Outcome|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
10875499|NCT00438399|EG000|Reported Event|Corticosteroid 1|All subjects having used Corticosteroid 1
10875500|NCT00438399|EG001|Reported Event|Corticosteroid 2|All subjects having used Corticosteroid 2
10875501|NCT00438399|EG002|Reported Event|Corticosteroid 3|All subjects having used Corticosteroid 3
10875502|NCT00438399|EG003|Reported Event|Clobetasol Propionate Shampoo|All subjects having used Clobetasol propionate shampoo
10875503|NCT00438451|BG000|Baseline|Levetiracetam|Levetiracetam 250mg
10875504|NCT00438451|BG001|Baseline|Carbamazepine|Carbamazepine 100mg
10875505|NCT00438451|BG002|Baseline|Lamotrigine|Lamotrigine 25mg
10875506|NCT00438451|BG003|Baseline|Total|Total of all reporting groups
10875507|NCT00438451|FG000|Participant Flow|Levetiracetam|"Levetiracetam 250mg: capsules, each containing one Levetiracetam 250mg film-coated tablet.~During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
10875508|NCT00438451|FG001|Participant Flow|Carbamazepine|"Carbamazepine 100mg: capsules, each containing half of one Carbamazepine 200mg slow release tablet.~During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
10875509|NCT00438451|FG002|Participant Flow|Lamotrigine|Lamotrigine 25mg: capsules, each containing one Lamotrigine 25mg tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.
10875510|NCT00438451|OG000|Outcome|Levetiracetam|Levetiracetam 250mg
10875511|NCT00438451|OG001|Outcome|Carbamazepine|Carbamazepine 100mg
10875512|NCT00438451|OG002|Outcome|Lamotrigine|Lamotrigine 25mg
10875513|NCT00438451|EG000|Reported Event|Levetiracetam|Levetiracetam 250mg
10875514|NCT00438451|EG001|Reported Event|Carbamazepine|Carbamazepine 100mg
10875515|NCT00438451|EG002|Reported Event|Lamotrigine|Lamotrigine 25mg
10875516|NCT00438464|BG000|Baseline|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
10875517|NCT00438464|BG001|Baseline|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
10875518|NCT00438464|BG002|Baseline|Total|Total of all reporting groups
10875519|NCT00438464|FG000|Participant Flow|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
10875520|NCT00438464|FG001|Participant Flow|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
10875521|NCT00438464|OG000|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
10875522|NCT00438464|OG001|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
10875523|NCT00438464|OG000|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
10875524|NCT00438464|OG001|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
10875525|NCT00438464|OG000|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
10986780|NCT00988000|FG000|Participant Flow|Agree to Alternative Study Invitation|Patients Respond to study invitation - agree to alternative consultation
10986781|NCT00988000|FG001|Participant Flow|Declined the Alternative Study Invitation|Patients respond to study invitation - declined/ non-responders for the invitation
10986782|NCT00988000|FG002|Participant Flow|Comparator|Patients - choose and book
10986783|NCT00988000|OG000|Outcome|Agree to the Alternative Consultation|Patients respond to study invitation and agree
10986784|NCT00988000|OG001|Outcome|Declined the Alternative Study Invitation|Declined/non-responders for the invitation
10986785|NCT00988000|OG002|Outcome|Comparator|Patients choose and book
10986786|NCT00988000|OG000|Outcome|Agree to the Alternative Study Invitation|Patients respond to study invitation and agree
10986787|NCT00988000|OG001|Outcome|Declined the Alternative Study Invitation|Declined/ non-responders to the alternative study invitation
10986788|NCT00988000|EG000|Reported Event|Agree to Alternative Study Invitation|Patients agree to alternative study invitation
10986789|NCT00988000|EG001|Reported Event|Declined the Alternative Study Invitation|Patients who declined/ non-responders to alternative study invitation
10986790|NCT00988000|EG002|Reported Event|Comparator|Patients - choose and book
10986791|NCT00988013|BG000|Baseline|IM-TMI (3Gy)|"Patients will receive 3Gy per day for 1 day (total of 3Gy).~IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day."
10986792|NCT00988013|BG001|Baseline|IM-TMI (6Gy)|"Patients will receive 3Gy per day for 2 days (for a total of 6Gy).~IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days."
10986793|NCT00988013|BG002|Baseline|IM-TMI (9Gy)|"Patients will receive 3Gy per day for 3 days (for a total of 9Gy).~IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days."
10986794|NCT00988013|BG003|Baseline|IM-TMI (12Gy)|"Patients will receive 3Gy per day for 4 days (for a total of 12Gy).~IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days."
10986795|NCT00988013|BG004|Baseline|Total|Total of all reporting groups
10986796|NCT00988013|FG000|Participant Flow|IM-TMI (3Gy)|"Patients will receive 3Gy per day for 1 day (total of 3Gy).~IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day."
10986797|NCT00988013|FG001|Participant Flow|IM-TMI (6Gy)|"Patients will receive 3Gy per day for 2 days (for a total of 6Gy).~IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days."
10986798|NCT00988013|FG002|Participant Flow|IM-TMI (9Gy)|"Patients will receive 3Gy per day for 3 days (for a total of 9Gy).~IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days."
10986799|NCT00988013|FG003|Participant Flow|IM-TMI (12Gy)|"Patients will receive 3Gy per day for 4 days (for a total of 12Gy).~IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days."
10986800|NCT00988013|OG000|Outcome|IM-TMI (3Gy)|"Patients will receive 3Gy per day for 1 day (total of 3Gy).~IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day."
10986801|NCT00988013|OG001|Outcome|IM-TMI (6Gy)|"Patients will receive 3Gy per day for 2 days (for a total of 6Gy).~IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days."
10986802|NCT00988013|OG002|Outcome|IM-TMI (12Gy)|"Patients will receive 3Gy per day for 3 days (for a total of 12Gy).~IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days."
10986803|NCT00988013|OG003|Outcome|IM-TMI (9Gy)|"Patients will receive 3Gy per day for 4 days (for a total of 9Gy).~IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days."
10986804|NCT00988013|OG002|Outcome|IM-TMI (9Gy)|"Patients will receive 3Gy per day for 3 days (for a total of 9Gy).~IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days."
10986805|NCT00988013|OG003|Outcome|IM-TMI (12Gy)|"Patients will receive 3Gy per day for 4 days (for a total of 12Gy).~IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days."
10986806|NCT00988013|EG000|Reported Event|IM-TMI (3Gy)|"Patients will receive 3Gy per day for 1 day (total of 3Gy).~IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day."
10986807|NCT00988013|EG001|Reported Event|IM-TMI (6Gy)|"Patients will receive 3Gy per day for 2 days (for a total of 6Gy).~IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days."
10986808|NCT00988013|EG002|Reported Event|IM-TMI (9Gy)|"Patients will receive 3Gy per day for 3 days (for a total of 9Gy).~IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days."
10986809|NCT00988013|EG003|Reported Event|IM-TMI (12Gy)|"Patients will receive 3Gy per day for 4 days (for a total of 12Gy).~IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days."
10986810|NCT00988065|BG000|Baseline|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986811|NCT00988065|BG001|Baseline|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986812|NCT00988065|BG002|Baseline|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986813|NCT00988065|BG003|Baseline|Total|Total of all reporting groups
10986814|NCT00988065|FG000|Participant Flow|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986815|NCT00988065|FG001|Participant Flow|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986816|NCT00988065|FG002|Participant Flow|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986817|NCT00988065|OG000|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986818|NCT00988065|OG001|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986819|NCT00988065|OG002|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986820|NCT00988065|EG000|Reported Event|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986821|NCT00988065|EG001|Reported Event|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10846469|NCT00276380|FG000|Participant Flow|EGb761®|"Subjects received EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
10875526|NCT00438464|OG001|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
10875527|NCT00438464|OG000|Outcome|GG3, Within Finasteride Arm|Participants with GG3 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
10875528|NCT00438464|OG001|Outcome|GG4, Within Finasteride Arm|Participants with GG4 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
10875529|NCT00438464|OG000|Outcome|GG3, Within Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
10875530|NCT00438464|OG001|Outcome|GG4, Within Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
10875531|NCT00438464|OG000|Outcome|Within GG3, Finasteride Arm|Participants with GG3 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
10875532|NCT00438464|OG001|Outcome|Within GG4, Finasteride Arm|Participants with GG4 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
10875533|NCT00438464|OG000|Outcome|Within GG3, Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
10875534|NCT00438464|OG001|Outcome|Within GG4, Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
10875535|NCT00438464|EG000|Reported Event|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
10875536|NCT00438464|EG001|Reported Event|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
10875537|NCT00438490|BG000|Baseline|Placebo|
10875538|NCT00438490|BG001|Baseline|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
10875539|NCT00438490|BG002|Baseline|Total|Total of all reporting groups
10875540|NCT00438490|FG000|Participant Flow|Placebo|Normal Saline Placebo once daily
10875541|NCT00438490|FG001|Participant Flow|Recombinant Human Prolactin|Recombinant Human Prolactin 60 mcg/kg once daily
10875542|NCT00438490|OG000|Outcome|Placebo|
10875543|NCT00438490|OG001|Outcome|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
10875544|NCT00438490|OG000|Outcome|Recombinant Human Prolactin|"Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection~Recombinant Human Prolactin"
10875545|NCT00438490|OG001|Outcome|Placebo|"Normal saline placebo subcutaneous injection~Recombinant Human Prolactin"
10875546|NCT00438490|OG000|Outcome|Placebo|Normal Saline Placebo once daily
10875547|NCT00438490|OG001|Outcome|Recombinant Human Prolactin|Recombinant Human Prolactin 60 mcg/kg once daily
10875548|NCT00438490|EG000|Reported Event|Placebo|Placebo
10875549|NCT00438490|EG001|Reported Event|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
10875550|NCT00438633|BG000|Baseline|Early Therapy|Subjects who begin therapy immediately after diagnosis of injury.
10875551|NCT00438633|BG001|Baseline|Late Therapy|Subjects who delay therapy for 3 weeks after diagnosis of injury.
10875552|NCT00438633|BG002|Baseline|Total|Total of all reporting groups
10875553|NCT00438633|FG000|Participant Flow|Early Therapy|Subjects who begin therapy immediately after diagnosis of injury.
10875554|NCT00438633|FG001|Participant Flow|Late Therapy|Subjects who delay therapy for 3 weeks after diagnosis of injury.
10875555|NCT00438633|OG000|Outcome|Early Therapy|Subjects who begin therapy immediately after diagnosis of injury.
10875556|NCT00438633|OG001|Outcome|Late Therapy|Subjects who delay therapy for 3 weeks after diagnosis of injury.
10875557|NCT00438633|EG000|Reported Event|Early Therapy|Subjects who begin therapy immediately after diagnosis of injury.
10875558|NCT00438633|EG001|Reported Event|Late Therapy|Subjects who delay therapy for 3 weeks after diagnosis of injury.
10875559|NCT00438659|BG000|Baseline|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
10875560|NCT00438659|BG001|Baseline|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
10875561|NCT00438659|BG002|Baseline|Total|Total of all reporting groups
10875562|NCT00438659|FG000|Participant Flow|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
10875563|NCT00438659|FG001|Participant Flow|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
10875564|NCT00438659|OG000|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
10875565|NCT00438659|OG001|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
10875566|NCT00438659|OG001|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
10875567|NCT00438659|EG000|Reported Event|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
10875568|NCT00438659|EG001|Reported Event|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
10875569|NCT00438672|BG000|Baseline|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
10875570|NCT00438672|BG001|Baseline|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
10875571|NCT00438672|BG002|Baseline|Total|Total of all reporting groups
10875572|NCT00438672|FG000|Participant Flow|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
10875573|NCT00438672|FG001|Participant Flow|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
10986822|NCT00988065|EG002|Reported Event|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
10986823|NCT00988091|BG000|Baseline|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
10986824|NCT00988091|BG001|Baseline|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
10986825|NCT00988091|BG002|Baseline|Total|Total of all reporting groups
10986826|NCT00988091|FG000|Participant Flow|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
10986827|NCT00988091|FG001|Participant Flow|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
10986828|NCT00988091|OG000|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
10986829|NCT00988091|OG001|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
10986830|NCT00988091|EG000|Reported Event|IA-SA: Double-blind Period|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
10986831|NCT00988091|EG001|Reported Event|IA-BioHA: Double-blind Period|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
10986832|NCT00988091|EG002|Reported Event|IA-BioHA: Open-label Period|Participants had the option of continuing into the open-label period in which their target knee received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) and they were followed for an additional 26 weeks.
10986833|NCT00988117|BG000|Baseline|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
10986834|NCT00988117|FG000|Participant Flow|Rivastigmine|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
10986835|NCT00988117|OG000|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
10986836|NCT00988117|EG000|Reported Event|Rivastigmine 4.6mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4.
10986837|NCT00988117|EG001|Reported Event|Rivastigmine 9.5 mg/24 Hours|The Exelon patch was administered at a dosage of 9.5 mg/24 hours from week 4 to 12.
10986838|NCT00988143|BG000|Baseline|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
10986839|NCT00988143|BG001|Baseline|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
10986840|NCT00988143|BG002|Baseline|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
10986841|NCT00988143|BG003|Baseline|Total|Total of all reporting groups
10986842|NCT00988143|FG000|Participant Flow|Study Group 1 (2009-2010 TIV)|Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives)
10986843|NCT00988143|FG001|Participant Flow|Study Group 2 (2008-2009 TIV)|Participants received the 2008-2009 Trivalent Influenza Vaccine
10986844|NCT00988143|FG002|Participant Flow|Study Group 3 (QIV)|Participants received the Quadrivalent Influenza Vaccine
10986845|NCT00988143|OG000|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
10986846|NCT00988143|OG001|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
10986847|NCT00988143|OG002|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
10986848|NCT00988143|EG000|Reported Event|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
10986849|NCT00988143|EG001|Reported Event|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
10986850|NCT00988143|EG002|Reported Event|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
10986851|NCT00988156|BG000|Baseline|Placebo|Placebo matching placebo
10986852|NCT00988156|BG001|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL or matching placebo. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
10875574|NCT00438672|OG000|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
10875575|NCT00438672|OG001|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
10875576|NCT00438672|EG000|Reported Event|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
10875577|NCT00438672|EG001|Reported Event|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
10875578|NCT00438750|BG000|Baseline|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
10875579|NCT00438750|BG001|Baseline|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
10875580|NCT00438750|BG002|Baseline|Total|Total of all reporting groups
10875581|NCT00438750|FG000|Participant Flow|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
10875582|NCT00438750|FG001|Participant Flow|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
10875583|NCT00438750|OG000|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
10875584|NCT00438750|OG001|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
10875585|NCT00438750|EG000|Reported Event|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
10875586|NCT00438750|EG001|Reported Event|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
10875587|NCT00438802|BG000|Baseline|Dose Level 1|"Starting Dose Level 1= 0.15 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875588|NCT00438802|BG001|Baseline|Dose Level 2|"Dose Level 2= 0.20 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875589|NCT00438802|BG002|Baseline|Dose Level 3|"Dose Level 3= 0.30 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875590|NCT00438802|BG003|Baseline|Total|Total of all reporting groups
10875591|NCT00438802|FG000|Participant Flow|Dose Level 1|"Starting Dose Level 1= 0.15 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875592|NCT00438802|FG001|Participant Flow|Dose Level 2|"Starting Dose Level 1= 0.20 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875593|NCT00438802|FG002|Participant Flow|Dose Level 3|"Starting Dose Level 1= 0.30 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875594|NCT00438802|OG000|Outcome|Dose Level 1|"Dose Level 1= 0.15 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875595|NCT00438802|OG001|Outcome|Dose Level 2|"Dose Level 2= 0.20 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875596|NCT00438802|OG002|Outcome|Dose Level 3|"Dose Level 3= 0.30 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875597|NCT00438802|OG000|Outcome|Dose Level 1|"Starting Dose Level 1= 0.15 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875598|NCT00438802|OG000|Outcome|All Patients|"Dose Level 1= 0.15 mg/kg> Dose Level 2= 0.20 mg/kg> Dose Level 3= 0.30 mg/kg> Each cycle is 4 weeks.> > Cycle 1 and 2:> Alefacept by IV Weekly>~> Cycles 3-12:> Alefacept by IV 1 x every 4 weeks"
10875599|NCT00438802|EG000|Reported Event|Dose Level 1|Alefacept by IV 1 x every 4 weeks
10875600|NCT00438802|EG001|Reported Event|Dose Level 2|Alefacept by IV 1 x every 4 weeks
10875601|NCT00438802|EG002|Reported Event|Dose Level 3|Alefacept by IV 1 x every 4 weeks
10875602|NCT00438815|BG000|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
10875603|NCT00438815|FG000|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
10875604|NCT00438815|OG000|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
10875605|NCT00438815|EG000|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
10875606|NCT00438854|BG000|Baseline|Dasatinib Treatment|"All patients were treated with Dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
10875607|NCT00438854|FG000|Participant Flow|Dasatinib Treatment|"All patients were treated with Dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
10875608|NCT00438854|OG000|Outcome|Dasatinib Treatment|"All patients were treated with dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
10986853|NCT00988156|BG002|Baseline|Total|Total of all reporting groups
10986854|NCT00988156|FG000|Participant Flow|Placebo|Placebo matching placebo
10986855|NCT00988156|FG001|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
10986856|NCT00988156|OG000|Outcome|Placebo|Placebo matching placebo
10986857|NCT00988156|OG001|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
10986858|NCT00988156|EG000|Reported Event|Placebo (Safety Set Part I)|
10986859|NCT00988156|EG001|Reported Event|Esl (Safety Set Part I)|
10986860|NCT00988169|BG000|Baseline|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
10875609|NCT00438854|EG000|Reported Event|Dasatinib Treatment|"All patients were treated with dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
10875610|NCT00438880|BG000|Baseline|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
10875611|NCT00438880|BG001|Baseline|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
10875612|NCT00438880|BG002|Baseline|Total|Total of all reporting groups
10875613|NCT00438880|FG000|Participant Flow|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
10875614|NCT00438880|FG001|Participant Flow|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
10875615|NCT00438880|OG000|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
10875616|NCT00438880|OG001|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
10875617|NCT00438880|EG000|Reported Event|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
10875618|NCT00438880|EG001|Reported Event|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
10875619|NCT00438932|BG000|Baseline|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
10875620|NCT00438932|BG001|Baseline|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
10875621|NCT00438932|BG002|Baseline|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
10875622|NCT00438932|BG003|Baseline|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
10875623|NCT00438932|BG004|Baseline|Total|Total of all reporting groups
10875624|NCT00438932|FG000|Participant Flow|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
10875625|NCT00438932|FG001|Participant Flow|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
10875626|NCT00438932|FG002|Participant Flow|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
10875627|NCT00438932|FG003|Participant Flow|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
10875628|NCT00438932|OG000|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
10875629|NCT00438932|OG001|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
10875630|NCT00438932|OG002|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
10875631|NCT00438932|OG003|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
10875632|NCT00438932|EG000|Reported Event|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
10875633|NCT00438932|EG001|Reported Event|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
10875634|NCT00438932|EG002|Reported Event|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
10875635|NCT00438932|EG003|Reported Event|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
10875636|NCT00438971|BG000|Baseline|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
10875637|NCT00438971|FG000|Participant Flow|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
10875638|NCT00438971|OG000|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
10875639|NCT00438971|OG000|Outcome|Duloxetine|
10875640|NCT00438971|EG000|Reported Event|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
10875641|NCT00439140|BG000|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
10875642|NCT00439140|BG001|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
10875643|NCT00439140|BG002|Baseline|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
10875644|NCT00439140|BG003|Baseline|Total|Total of all reporting groups
10875645|NCT00439140|FG000|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
10875646|NCT00439140|FG001|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
10875647|NCT00439140|FG002|Participant Flow|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1. (If applicable after 12 weeks, participants received either botulinum toxin Type A 200U or 300U in Treatment Cycle 2.)
10875648|NCT00439140|OG000|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
10875649|NCT00439140|OG001|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
10875650|NCT00439140|OG002|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
10875651|NCT00439140|EG000|Reported Event|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
10875652|NCT00439140|EG001|Reported Event|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
10875653|NCT00439140|EG002|Reported Event|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
10875654|NCT00439179|BG000|Baseline|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
10875655|NCT00439179|BG001|Baseline|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
10875656|NCT00439179|BG002|Baseline|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
10875657|NCT00439179|BG003|Baseline|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
10875658|NCT00439179|BG004|Baseline|Total|Total of all reporting groups
10875659|NCT00439179|FG000|Participant Flow|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)
10875660|NCT00439179|FG001|Participant Flow|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)
10875661|NCT00439179|FG002|Participant Flow|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)
10875662|NCT00439179|FG003|Participant Flow|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)
10875663|NCT00439179|OG000|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
10875664|NCT00439179|OG001|Outcome|Cohort 2|weekly gem+ GW572016, 1500mg/day
10875665|NCT00439179|OG002|Outcome|Cohort 3|GEMOX+ GW572016 1000mg day
10875666|NCT00439179|OG003|Outcome|Cohort 4|GEMOX+ GW572016 1500mg/day
10875667|NCT00439179|OG001|Outcome|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
10875668|NCT00439179|OG002|Outcome|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
10875669|NCT00439179|OG003|Outcome|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
10875670|NCT00439179|EG000|Reported Event|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
10875671|NCT00439179|EG001|Reported Event|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
10875672|NCT00439179|EG002|Reported Event|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
10875673|NCT00439179|EG003|Reported Event|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
10986861|NCT00988169|FG000|Participant Flow|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
10986862|NCT00988169|OG000|Outcome|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
10986863|NCT00988169|EG000|Reported Event|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
10986864|NCT00988208|BG000|Baseline|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
10986865|NCT00988208|BG001|Baseline|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
10986866|NCT00988208|BG002|Baseline|Total|Total of all reporting groups
10986867|NCT00988208|FG000|Participant Flow|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
10986868|NCT00988208|FG001|Participant Flow|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
10986869|NCT00988208|OG000|Outcome|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
10986870|NCT00988208|OG001|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
10986871|NCT00988208|EG000|Reported Event|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
10986872|NCT00988208|EG001|Reported Event|Docetaxel/ Prednisone/and Placebo (DP)|Participants received Docetaxel 75 mg/m^2 by intravenous (IV) administration over 30-60 minutes on Day 1, Prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
10986873|NCT00988221|BG000|Baseline|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
10986874|NCT00988221|BG001|Baseline|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986875|NCT00988221|BG002|Baseline|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986876|NCT00988221|BG003|Baseline|Total|Total of all reporting groups
10986877|NCT00988221|FG000|Participant Flow|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
10986878|NCT00988221|FG001|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986879|NCT00988221|FG002|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986880|NCT00988221|FG003|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
10986881|NCT00988221|OG000|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
10986882|NCT00988221|OG001|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
10986883|NCT00988221|OG000|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
10986884|NCT00988221|OG001|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986885|NCT00988221|OG002|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986886|NCT00988221|OG003|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
10986887|NCT00988221|OG001|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
10986888|NCT00988221|OG002|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986889|NCT00988221|OG003|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986890|NCT00988221|OG004|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
10986891|NCT00988221|OG000|Outcome|Placebo to Tocilizumab|Patients received placebo to tocilizumab intravenously every 4 weeks.
10986892|NCT00988221|OG002|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
10986893|NCT00988221|EG000|Reported Event|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
10986894|NCT00988221|EG001|Reported Event|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
10986895|NCT00988221|EG002|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986896|NCT00988221|EG003|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10986897|NCT00988221|EG004|Reported Event|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
10986898|NCT00988325|BG000|Baseline|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
10986899|NCT00988325|BG001|Baseline|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
10986900|NCT00988325|BG002|Baseline|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
10986901|NCT00988325|BG003|Baseline|Total|Total of all reporting groups
10986902|NCT00988325|FG000|Participant Flow|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
10986903|NCT00988325|FG001|Participant Flow|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
10986904|NCT00988325|FG002|Participant Flow|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days.
10986905|NCT00988325|OG000|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
10986906|NCT00988325|OG001|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
10986907|NCT00988325|OG002|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
10986908|NCT00988325|OG000|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
10986909|NCT00988325|OG000|Outcome|Type A (H1N1)pdm09|Genotype A (H1N1)pdm09 was present in 21 participants of age group 91 to <365 days, 9 participants of age group 31 to 90 days, and 2 participants of age group <=30 days
10986910|NCT00988325|OG001|Outcome|Type A H3|Genotype Type A H3 was present in 4 participants and 6 participants of age groups 91 to <365 days and 31 to 90 days, respectively
10986911|NCT00988325|OG002|Outcome|Type B|Genotype B was present in 12, 2, and 2 participants of age groups <365 days, 31 to 90 days, and <=30 days, respectively.
10986912|NCT00988325|EG000|Reported Event|Oseltamivir 3 mg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
10986913|NCT00988325|EG001|Reported Event|Oseltamivir 2.5 mg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/ twice a day for 5 days
10986914|NCT00988325|EG002|Reported Event|Oseltamivir 2 mg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
10986915|NCT00988351|BG000|Baseline|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
10846470|NCT00276380|FG001|Participant Flow|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
10986916|NCT00988351|BG001|Baseline|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
10986917|NCT00988351|BG002|Baseline|Total|Total of all reporting groups
10986918|NCT00988351|FG000|Participant Flow|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
10986919|NCT00988351|FG001|Participant Flow|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
10986920|NCT00988351|OG000|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
10986921|NCT00988351|OG001|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
10986922|NCT00988351|EG000|Reported Event|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
10986923|NCT00988351|EG001|Reported Event|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
10986924|NCT00988429|BG000|Baseline|Placebo|Matching placebo tablets QD orally
10986925|NCT00988429|BG001|Baseline|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
10986926|NCT00988429|BG002|Baseline|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
10986927|NCT00988429|BG003|Baseline|Total|Total of all reporting groups
10986928|NCT00988429|FG000|Participant Flow|Placebo|Matching placebo tablets QD orally
10986929|NCT00988429|FG001|Participant Flow|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
10986930|NCT00988429|FG002|Participant Flow|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
10986931|NCT00988429|OG000|Outcome|Placebo (ITT Population)|Matching placebo tablets QD orally
10986932|NCT00988429|OG001|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
10986933|NCT00988429|OG002|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
10986934|NCT00988429|OG000|Outcome|Placebo|Matching placebo tablets QD orally
10986935|NCT00988429|EG000|Reported Event|Placebo (Safety Population)|Matching placebo tablets QD orally
10986936|NCT00988429|EG001|Reported Event|ESL 800 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
10986937|NCT00988429|EG002|Reported Event|ESL 1200 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
11007255|NCT01090050|OG001|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
11007256|NCT01090050|EG000|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
11007257|NCT01090050|EG001|Reported Event|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
11007258|NCT01090063|BG000|Baseline|Main|
11007259|NCT01090063|FG000|Participant Flow|Main|All participants were treated the same
11007260|NCT01090063|OG000|Outcome|Main|Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.
11007261|NCT01090063|OG000|Outcome|Median PGA|Median PGA at Week 24
11007262|NCT01090063|OG000|Outcome|Mean Pustule Count at Baseline|Average number of pustules present in all subjects at baseline
11007263|NCT01090063|OG001|Outcome|Mean Pustule Count at Week 24|Average number of pustules present in all subjects at week 24
11007264|NCT01090063|OG000|Outcome|Mean Baseline Fissure Count|Average number of fissures found on hands and feet at baseline
11007265|NCT01090063|OG001|Outcome|Mean Week 24 Fissure Count|Average number of fissures found on hands and feet at Week 24
11007266|NCT01090063|OG000|Outcome|Mean Baseline Pruritus VAS Score|Average pruritus VAS score as measured at baseline. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
11007267|NCT01090063|OG001|Outcome|Mean Week 24 Pruritus VAS Score|Average pruritus VAS score as measured at week 24. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
11007268|NCT01090063|OG000|Outcome|Mean Baseline Pain VAS Score|Average score of the pain VAS at baseline. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
11007269|NCT01090063|OG001|Outcome|Mean Week 24 Pain VAS Score|Average score of the pain VAS at Week 24. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
11007270|NCT01090063|OG000|Outcome|Number of Participants With AEs|
11007271|NCT01090063|EG000|Reported Event|Main|
11007272|NCT01090076|BG000|Baseline|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
11007273|NCT01090076|BG001|Baseline|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
11007274|NCT01090076|BG002|Baseline|Total|Total of all reporting groups
11007275|NCT01090076|FG000|Participant Flow|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
11007276|NCT01090076|FG001|Participant Flow|Placebo|Placebo x 2 sachets/d
11007277|NCT01090076|OG000|Outcome|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
11007278|NCT01090076|OG001|Outcome|Placebo|Placebo x 2 sachets/d
11007279|NCT01090076|OG000|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
11007280|NCT01090076|OG001|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
11007281|NCT01090076|EG000|Reported Event|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
10986938|NCT00988442|BG000|Baseline|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
10986939|NCT00988442|BG001|Baseline|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
10986940|NCT00988442|BG002|Baseline|Total|Total of all reporting groups
10986941|NCT00988442|FG000|Participant Flow|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
10986942|NCT00988442|FG001|Participant Flow|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
10986943|NCT00988442|OG000|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
10986944|NCT00988442|OG001|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
10986945|NCT00988442|OG001|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this may vary by study site."
10986946|NCT00988442|OG000|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Usual ACTG site care."
10986947|NCT00988442|OG001|Outcome|Standard Care|"Participants received care as usual.~Standard care: Usual ACTG site care."
10986948|NCT00988442|EG000|Reported Event|Enhanced Nursing Telephone Support With Standard Care|"Participants will receive enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses may schedule more frequent calls at their discretion. Calls will provide information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants starting a new ART regimen; this may vary by study site."
10986949|NCT00988442|EG001|Reported Event|Standard Care|"Participants will receive care as usual.~Standard care: Care as usual for participants starting a new ART regimen; this may vary by study site."
10986950|NCT00988533|BG000|Baseline|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
10986951|NCT00988533|FG000|Participant Flow|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
10986952|NCT00988533|OG000|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
10986953|NCT00988533|EG000|Reported Event|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
10986954|NCT00988559|BG000|Baseline|PMED Delivery - Groups 1 and 2|"Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986955|NCT00988559|BG001|Baseline|IM Injections - Groups 5 and 6|"Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10846471|NCT00276380|OG000|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch"
10986956|NCT00988559|BG002|Baseline|Intralesional Delivery - Group 3 and 4|"Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986957|NCT00988559|BG003|Baseline|Intralesional Delivery + Imiquimod - Group 7|"Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally~therapeutic resection of the lesion: at week 15, all residual lesions will be resected~imiquimod: imiquimod applied to the cervix by the physician"
10986958|NCT00988559|BG004|Baseline|Total|Total of all reporting groups
10986959|NCT00988559|FG000|Participant Flow|PMED Delivery - Groups 1 and 2|"Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986960|NCT00988559|FG001|Participant Flow|IM Injections - Groups 5 and 6|"Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986961|NCT00988559|FG002|Participant Flow|Intralesional Delivery - Group 3 and 4|"Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986962|NCT00988559|FG003|Participant Flow|Intralesional Delivery + Imiquimod - Group 7|"Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally~therapeutic resection of the lesion: at week 15, all residual lesions will be resected~imiquimod: imiquimod applied to the cervix by the physician"
10986963|NCT00988559|OG000|Outcome|PMED Delivery - Groups 1 and 2|"Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986964|NCT00988559|OG001|Outcome|IM Injections - Groups 5 and 6|"Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986965|NCT00988559|OG002|Outcome|Intralesional Delivery - Group 3 and 4|"Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986966|NCT00988559|OG003|Outcome|Intralesional Delivery + Imiquimod - Group 7|"Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally~therapeutic resection of the lesion: at week 15, all residual lesions will be resected~imiquimod: imiquimod applied to the cervix by the physician"
10986967|NCT00988559|EG000|Reported Event|PMED Delivery - Groups 1 and 2|"Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986968|NCT00988559|EG001|Reported Event|IM Injections - Groups 5 and 6|"Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986969|NCT00988559|EG002|Reported Event|Intralesional Delivery - Group 3 and 4|"Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally~therapeutic resection of the lesion: at week 15, all residual lesions will be resected"
10986970|NCT00988559|EG003|Reported Event|Intralesional Delivery + Imiquimod - Group 7|"Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.~DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)~intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally~therapeutic resection of the lesion: at week 15, all residual lesions will be resected~imiquimod: imiquimod applied to the cervix by the physician"
10986971|NCT00988598|BG000|Baseline|PF-04447943 25 mg + Donepezil|PF-04447943 25 mg tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
10986972|NCT00988598|BG001|Baseline|Placebo + Donepezil|Placebo matched to PF-04447943 tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
10986973|NCT00988598|BG002|Baseline|Total|Total of all reporting groups
10986974|NCT00988598|FG000|Participant Flow|PF-04447943 25 mg + Donepezil|PF-04447943 25 milligram (mg) tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
10986975|NCT00988598|FG001|Participant Flow|Placebo + Donepezil|Placebo matched to PF-04447943 tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
10986976|NCT00988598|OG000|Outcome|PF-04447943 25 mg + Donepezil|PF-04447943 25 mg tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
10986977|NCT00988598|OG001|Outcome|Placebo + Donepezil|Placebo matched to PF-04447943 tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
10986978|NCT00988598|EG000|Reported Event|PF-04447943 25 mg + Donepezil|PF-04447943 25 mg tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
10986979|NCT00988598|EG001|Reported Event|Placebo + Donepezil|Placebo matched to PF-04447943 tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
10986980|NCT00988637|BG000|Baseline|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
10986981|NCT00988637|BG001|Baseline|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
10986982|NCT00988637|BG002|Baseline|Total|Total of all reporting groups
10986983|NCT00988637|FG000|Participant Flow|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
10986984|NCT00988637|FG001|Participant Flow|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
10986985|NCT00988637|OG000|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
10986986|NCT00988637|OG001|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
10986987|NCT00988637|EG000|Reported Event|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
10986988|NCT00988637|EG001|Reported Event|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
10986989|NCT00988832|BG000|Baseline|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn's disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
10986990|NCT00988832|FG000|Participant Flow|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn's disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
10986991|NCT00988832|OG000|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
10986992|NCT00988832|OG001|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
10986993|NCT00988832|OG002|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
10986994|NCT00988832|OG003|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
10986995|NCT00988832|EG000|Reported Event|INFLIXIMAB, RECOMBINANT|Infliximab as prescribed by a physician in normal practice for Crohn's disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
10986996|NCT00988858|BG000|Baseline|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
10986997|NCT00988858|FG000|Participant Flow|LY2603618 and Pemetrexed|"LY2603618: 150 milligram per square meter mg/m^2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression~Pemetrexed: 500mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
10986998|NCT00988858|OG000|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
10986999|NCT00988858|EG000|Reported Event|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
10987000|NCT00988884|BG000|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
10987001|NCT00988884|BG001|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
10987002|NCT00988884|BG002|Baseline|Total|Total of all reporting groups
10987003|NCT00988884|FG000|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
10987004|NCT00988884|FG001|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
10987005|NCT00988884|OG000|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
10987006|NCT00988884|OG001|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
10987007|NCT00988884|EG000|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
10987008|NCT00988884|EG001|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
10987009|NCT00989014|BG000|Baseline|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
10987010|NCT00989014|BG001|Baseline|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
10987011|NCT00989014|BG002|Baseline|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
10987012|NCT00989014|BG003|Baseline|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
10987013|NCT00989014|BG004|Baseline|Total|Total of all reporting groups
10987014|NCT00989014|FG000|Participant Flow|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
10987015|NCT00989014|FG001|Participant Flow|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
10987016|NCT00989014|FG002|Participant Flow|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
10987017|NCT00989014|FG003|Participant Flow|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
10987018|NCT00989014|OG000|Outcome|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
10987019|NCT00989014|OG001|Outcome|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
10987020|NCT00989014|OG002|Outcome|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
10987021|NCT00989014|OG003|Outcome|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
10987022|NCT00989014|EG000|Reported Event|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
10987023|NCT00989014|EG001|Reported Event|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
10846472|NCT00276380|OG001|Outcome|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
10987024|NCT00989014|EG002|Reported Event|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
10987025|NCT00989014|EG003|Reported Event|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
10987026|NCT00989092|BG000|Baseline|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
10987027|NCT00989092|BG001|Baseline|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
10987028|NCT00989092|BG002|Baseline|Total|Total of all reporting groups
10987029|NCT00989092|FG000|Participant Flow|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
10987030|NCT00989092|FG001|Participant Flow|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
10987031|NCT00989092|OG000|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
10987032|NCT00989092|OG001|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
10987033|NCT00989092|EG000|Reported Event|Treatment Arm|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
11007282|NCT01090076|EG001|Reported Event|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
10987034|NCT00989092|EG001|Reported Event|Observation Arm Treated|Participants in the observation group who received darbepoetin alfa, initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL. Adverse events for participants in this group could have been reported at any time during the study; and therefore, may have occurred before darbepoetin alfa administration.
10987035|NCT00989092|EG002|Reported Event|Observation Arm Not Treated|Participants in the observation group who did not receive any darbepoetin alfa treatment.
10987036|NCT00989157|BG000|Baseline|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
10987037|NCT00989157|BG001|Baseline|Control|Subjects matched to the bariatric subjects via BMI, age and gender
10987038|NCT00989157|BG002|Baseline|Total|Total of all reporting groups
10987039|NCT00989157|FG000|Participant Flow|Control|Matched to bariatric subject via BMI, age and gender
10987040|NCT00989157|FG001|Participant Flow|Bariatric|One year post surgery
10987041|NCT00989157|OG000|Outcome|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
10987042|NCT00989157|OG001|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender
10987043|NCT00989157|OG000|Outcome|Bariatric|Subjects one year post surgery
10987044|NCT00989157|OG001|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
10987045|NCT00989157|EG000|Reported Event|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
10987046|NCT00989157|EG001|Reported Event|Control|Subjects matched to the bariatric subjects via BMI, age and gender
10987047|NCT00989196|BG000|Baseline|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
10987048|NCT00989196|FG000|Participant Flow|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Kogenate (50 IU/kg bodyweight)
10987049|NCT00989196|FG001|Participant Flow|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
10987050|NCT00989196|OG000|Outcome|Human cl rhFVIII|Human-cl rhFVIII 50 IU/kg for PK dose
10987051|NCT00989196|OG001|Outcome|Kogenate FS|Kogenate FS 50 IU/kg for PK dose
10987052|NCT00989196|OG000|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
10987053|NCT00989196|EG000|Reported Event|Human cl rhFVIII and Kogenate FS|All participants. Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK period. After the PK period all participants received Human-cl rhFVIII in the treatment period.
10987054|NCT00989235|BG000|Baseline|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
10987055|NCT00989235|BG001|Baseline|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
10987056|NCT00989235|BG002|Baseline|Total|Total of all reporting groups
10987057|NCT00989235|FG000|Participant Flow|Abatacept (10 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
10987058|NCT00989235|FG001|Participant Flow|Abatacept (5 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
10987059|NCT00989235|OG000|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
10987060|NCT00989235|OG001|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
10987061|NCT00989235|OG000|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
10987062|NCT00989235|OG001|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
10987063|NCT00989235|EG000|Reported Event|Abatacept 5mg/kg (ST)|
10987064|NCT00989235|EG001|Reported Event|Abatacept 10mg/kg (ST)|
10987065|NCT00989235|EG002|Reported Event|Abatacept 10mg/kg (Open-Label)|
10987066|NCT00989261|BG000|Baseline|Cohort 1; ≥60 Years of Age|"Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.~Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)~After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day."
10987067|NCT00989261|BG001|Baseline|Cohort 2; ≥18 Years of Age|"Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.~Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)~After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day."
10987068|NCT00989261|BG002|Baseline|Total|Total of all reporting groups
11007283|NCT01090102|BG000|Baseline|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
10987069|NCT00989261|FG000|Participant Flow|Cohort 1; ≥60 Years of Age|"Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.~Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)~After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day."
10987070|NCT00989261|FG001|Participant Flow|Cohort 2; ≥18 Years of Age|"Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.~Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)~After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day."
10987071|NCT00989261|OG000|Outcome|Cohort 1; ≥60 Years of Age|"Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.~Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0~Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1~Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1~After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day."
10987072|NCT00989261|OG001|Outcome|Cohort 2; ≥18 Years of Age|"Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.~Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0~Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0~Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0~After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day."
10987073|NCT00989261|EG000|Reported Event|Cohort 1; ≥60 Years of Age|"FLT3-ITD positive and negative populations will be divided into 2 cohorts as follows:~Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.~Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)~After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day."
10987074|NCT00989261|EG001|Reported Event|Cohort 2; ≥18 Years of Age|"Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.~Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)~After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day."
10987075|NCT00989287|BG000|Baseline|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987076|NCT00989287|BG001|Baseline|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987077|NCT00989287|BG002|Baseline|Total|Total of all reporting groups
10987078|NCT00989287|FG000|Participant Flow|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987079|NCT00989287|FG001|Participant Flow|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987080|NCT00989287|OG000|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987081|NCT00989287|OG001|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987082|NCT00989287|OG000|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987083|NCT00989287|OG001|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987084|NCT00989287|OG002|Outcome|GSK2340272A (41-60y)|Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987085|NCT00989287|OG003|Outcome|GSK2340269A (41-60y)|Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987086|NCT00989287|OG004|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987087|NCT00989287|OG005|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987088|NCT00989287|OG006|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987089|NCT00989287|OG007|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987090|NCT00989287|OG002|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987091|NCT00989287|OG003|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987092|NCT00989287|OG004|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987093|NCT00989287|OG005|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987094|NCT00989287|OG001|Outcome|GSK2340269A Group|New Group 2 Description
10987095|NCT00989287|EG000|Reported Event|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987096|NCT00989287|EG001|Reported Event|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11348173|NCT04206800|OG000|Outcome|Routine Care|Routine care is normally having men abstain from ejaculation from 2 to 5 days prior to the scheduled oocyte retrieval date. Men in the routine care arm will abstain from ejaculation greater than 48 hours before providing a semen sample the day of the scheduled oocyte retrieval.
10987097|NCT00989573|BG000|Baseline|OPC-6535 25 mg|Oral administration of OPC-6535 25 mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week)
10987098|NCT00989573|BG001|Baseline|OPC-6535 50 mg|Oral administration of OPC-6535 50mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week, with further titration to 50 mg from the third week)
10987099|NCT00989573|BG002|Baseline|Placebo|Oral administration of placebo once daily for 8 weeks
10987100|NCT00989573|BG003|Baseline|Total|Total of all reporting groups
10987101|NCT00989573|FG000|Participant Flow|OPC-6535 25 mg|Oral administration of OPC-6535 25 mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week)
10987102|NCT00989573|FG001|Participant Flow|OPC-6535 50 mg|Oral administration of OPC-6535 50mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week, with further titration to 50 mg from the third week)
10987103|NCT00989573|FG002|Participant Flow|Placebo|Oral administration of placebo once daily for 8 weeks
10987104|NCT00989573|OG000|Outcome|OPC-6535 25 mg|Oral administration of OPC-6535 25 mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week)
10987105|NCT00989573|OG001|Outcome|OPC-6535 50 mg|Oral administration of OPC-6535 50mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week, with further titration to 50 mg from the third week)
10987106|NCT00989573|OG002|Outcome|Placebo|Oral administration of placebo once daily for 8 weeks
10987107|NCT00989573|EG000|Reported Event|OPC-6535 25 mg|Oral administration of OPC-6535 25 mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week)
10987108|NCT00989573|EG001|Reported Event|OPC-6535 50 mg|Oral administration of OPC-6535 50mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week, with further titration to 50 mg from the third week)
10987109|NCT00989573|EG002|Reported Event|Placebo|Oral administration of placebo once daily for 8 weeks
10987110|NCT00989586|BG000|Baseline|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
11007284|NCT01090102|BG001|Baseline|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
11007285|NCT01090102|BG002|Baseline|Total|Total of all reporting groups
11007286|NCT01090102|FG000|Participant Flow|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
11348174|NCT04206800|OG001|Outcome|Ejaculatory Abstinence Less Than 24 Hours|"Males will ejaculate within 24 hours of the scheduled oocyte retrieval date.~Ejaculatory abstinence less than 24 hours: Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval"
10987111|NCT00989586|BG001|Baseline|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
10987112|NCT00989586|BG002|Baseline|Total|Total of all reporting groups
10987113|NCT00989586|FG000|Participant Flow|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
10987114|NCT00989586|FG001|Participant Flow|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
10987115|NCT00989586|OG000|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
10987116|NCT00989586|OG000|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
10987117|NCT00989586|OG001|Outcome|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
10987118|NCT00989586|OG000|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
10987119|NCT00989586|EG000|Reported Event|All Patients From Phase I and Phase II|Toxicities were graded according to NCI Common Toxicity Criteria for Adverse Events version 3.0 and classified as either unrelated, unlikely, possibly, probably or definitely related to study treatment.
10987120|NCT00989612|BG000|Baseline|GSK2340274A Group|Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987121|NCT00989612|FG000|Participant Flow|GSK2340274A Group|Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987122|NCT00989612|OG000|Outcome|GSK2340274A Group|Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987123|NCT00989612|OG000|Outcome|GSK2340274A 20-40Y Group|Healthy subjects, aged 20 to 40 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987124|NCT00989612|OG001|Outcome|GSK2340274A 41-64Y Group|Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987125|NCT00989612|EG000|Reported Event|GSK2340274A Group|Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987126|NCT00989664|BG000|Baseline|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10987127|NCT00989664|FG000|Participant Flow|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10987128|NCT00989664|OG000|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10987129|NCT00989664|OG001|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
10987130|NCT00989664|OG001|Outcome|LQCR|Participants treated with at least two chemotherapy regimens before enrolling in study BEX104504
10987131|NCT00989664|EG000|Reported Event|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10987132|NCT00989768|BG000|Baseline|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
10987133|NCT00989768|FG000|Participant Flow|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
10987134|NCT00989768|OG000|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
10987135|NCT00989768|OG001|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
10987136|NCT00989768|OG000|Outcome|Dysport® 5U|Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
10987137|NCT00989768|OG001|Outcome|Botox ® 2U|Two units of Botox® was administered to the other side of the frontal region.
10987138|NCT00989768|OG001|Outcome|Botox® 2U|Two units of Botox® was administered two units to the other side of frontal region
10987139|NCT00989768|EG000|Reported Event|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
10987140|NCT00989781|BG000|Baseline|PCOS Women|"Each subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above."
11007287|NCT01090102|FG001|Participant Flow|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
10987141|NCT00989781|BG001|Baseline|Normal Women|"Each subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above."
10987142|NCT00989781|BG002|Baseline|Total|Total of all reporting groups
10987143|NCT00989781|FG000|Participant Flow|PCOS Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
10987144|NCT00989781|FG001|Participant Flow|Normal Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
10987145|NCT00989781|OG000|Outcome|NR-PCOS Women|"PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
10987146|NCT00989781|OG001|Outcome|HR-PCOS Women|"PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
10987147|NCT00989781|OG002|Outcome|Normal Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
10987148|NCT00989781|EG000|Reported Event|PCOS Women|"Each subject will undergo pelvic 3D ultrasound and an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given before ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals, the r-hCG stimulation test and OGTT will be repeated as described above.~3-D Ultrasound: One time pelvic ultrasound~recombinant human chorionic gonadotropin: Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards~Recombinant human follicle stimulating"
10987149|NCT00989781|EG001|Reported Event|Normal Women|"Each subject will undergo pelvic 3D ultrasound and an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals, the r-hCG stimulation test and OGTT will be repeated as described above.~3-D Ultrasound: One time pelvic ultrasound~recombinant human chorionic gonadotropin: Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards~Recombinant human follicle stimulati"
10987150|NCT00989833|BG000|Baseline|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
10987151|NCT00989833|BG001|Baseline|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
10987152|NCT00989833|BG002|Baseline|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
10987153|NCT00989833|BG003|Baseline|Total|Total of all reporting groups
10987154|NCT00989833|FG000|Participant Flow|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
10987155|NCT00989833|FG001|Participant Flow|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
10987156|NCT00989833|FG002|Participant Flow|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
10987157|NCT00989833|OG000|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
10987158|NCT00989833|OG001|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
10987159|NCT00989833|OG002|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
10987160|NCT00989833|EG000|Reported Event|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
10987161|NCT00989833|EG001|Reported Event|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
10987162|NCT00989833|EG002|Reported Event|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
10987163|NCT00989911|BG000|Baseline|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
10987164|NCT00989911|FG000|Participant Flow|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
10987165|NCT00989911|OG000|Outcome|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
10987166|NCT00989911|EG000|Reported Event|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
11348175|NCT04206800|EG000|Reported Event|Routine Care|Routine care is normally having men abstain from ejaculation from 2 to 5 days prior to the scheduled oocyte retrieval date. Men in the routine care arm will abstain from ejaculation greater than 48 hours before providing a semen sample the day of the scheduled oocyte retrieval.
11348176|NCT04206800|EG001|Reported Event|Ejaculatory Abstinence Less Than 24 Hours|"Males will ejaculate within 24 hours of the scheduled oocyte retrieval date.~Ejaculatory abstinence less than 24 hours: Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval"
11348177|NCT04205669|BG000|Baseline|Individual Treatment|Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
10987167|NCT00989950|BG000|Baseline|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987168|NCT00989950|BG001|Baseline|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987169|NCT00989950|BG002|Baseline|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987170|NCT00989950|BG003|Baseline|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987171|NCT00989950|BG004|Baseline|Total|Total of all reporting groups
10987172|NCT00989950|FG000|Participant Flow|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987173|NCT00989950|FG001|Participant Flow|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987174|NCT00989950|FG002|Participant Flow|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987175|NCT00989950|FG003|Participant Flow|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987176|NCT00989950|OG000|Outcome|9 hr Wear|Result for all patients when patch worn for 9 hrs/day
10987177|NCT00989950|OG001|Outcome|10 hr Wear|Result for all patients when patch worn for 10 hrs/day
10987178|NCT00989950|OG002|Outcome|11 hr Wear|Result for all patients when patch worn for 11 hrs/day
10987179|NCT00989950|OG003|Outcome|12 hr Wear|Result for all patients when patch worn for 12 hrs/day
10987180|NCT00989950|EG000|Reported Event|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987181|NCT00989950|EG001|Reported Event|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987182|NCT00989950|EG002|Reported Event|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987183|NCT00989950|EG003|Reported Event|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
10987184|NCT00989963|BG000|Baseline|Low Fixed Dose Group (60 ug)|Participants in the low dose group received 60 microgram of Beraprost sodium modified release tablets, orally twice daily up to maximum duration of Week 12.
10987185|NCT00989963|BG001|Baseline|High Fixed Dose Group (240 ug)|Participants in the high dose group received starting dose of 60 microgram of Beraprost sodium modified release tablets twice daily which was escalated until they reached the fixed maximum dose of 240 microgram twice daily up to a maximum duration of Week 12
10987186|NCT00989963|BG002|Baseline|Maximum Tolerated Dose (MTD)|Participants in this group received starting dose of 60 microgram of Beraprost sodium modified release tablets twice daily which was escalated until they reached the fixed maximum dose of 600 microgram twice daily up to a maximum duration of Week 12 or they reached an intolerable dose which required them to down-titrate by 60 microgram twice daily in these instances and at the Investigator's discretion, further attempts at dose escalation may have been made.
10987187|NCT00989963|BG003|Baseline|Total|Total of all reporting groups
10987188|NCT00989963|FG000|Participant Flow|Low Fixed Dose Group (60 ug)|Participants in the low dose group received 60 microgram of Beraprost sodium modified release tablets, orally twice daily up to maximum duration of Week 12.
10987189|NCT00989963|FG001|Participant Flow|High Fixed Dose (FD) Group (240 ug)|Participants in the high dose group received starting dose of 60 microgram of Beraprost sodium modified release tablets twice daily which was escalated until they reached the fixed maximum dose of 240 microgram twice daily up to a maximum duration of Week 12
10987190|NCT00989963|FG002|Participant Flow|Maximum Tolerated Dose (MTD)|Participants in this group received starting dose of 60 microgram of Beraprost sodium modified release tablets twice daily which was escalated until they reached the fixed maximum dose of 600 microgram twice daily up to a maximum duration of Week 12 or they reached an intolerable dose which required them to down-titrate by 60 microgram twice daily in these instances and at the Investigator's discretion, further attempts at dose escalation may have been made.
10987191|NCT00989963|OG000|Outcome|Low Fixed Dose Group (60 ug)|Participants in the low dose group received 60 microgram of Beraprost sodium modified release tablets, orally twice daily up to maximum duration of Week 12.
10987192|NCT00989963|OG001|Outcome|High Fixed Dose Group (240 ug)|Participants in the high dose group received starting dose of 60 microgram of Beraprost sodium modified release tablets twice daily which was escalated until they reached the fixed maximum dose of 240 microgram twice daily up to a maximum duration of Week 12
10987193|NCT00989963|OG002|Outcome|Maximum Tolerated Dose (MTD)|Participants in this group received starting dose of 60 microgram of Beraprost sodium modified release tablets twice daily which was escalated until they reached the fixed maximum dose of 600 microgram twice daily up to a maximum duration of Week 12 or they reached an intolerable dose which required them to down-titrate by 60 microgram twice daily in these instances and at the Investigator's discretion, further attempts at dose escalation may have been made.
10987194|NCT00989963|EG000|Reported Event|Low Fixed Dose Group (60 ug)|Participants in the low dose group received 60 microgram of Beraprost sodium modified release tablets, orally twice daily up to maximum duration of Week 12.
10987195|NCT00989963|EG001|Reported Event|High Fixed Dose Group (240 ug)|Participants in the high dose group received starting dose of 60 microgram of Beraprost sodium modified release tablets twice daily which was escalated until they reached the fixed maximum dose of 240 microgram twice daily up to a maximum duration of Week 12
10987196|NCT00989963|EG002|Reported Event|Maximum Tolerated Dose (MTD)|Participants in this group received starting dose of 60 microgram of Beraprost sodium modified release tablets twice daily which was escalated until they reached the fixed maximum dose of 600 microgram twice daily up to a maximum duration of Week 12 or they reached an intolerable dose which required them to down-titrate by 60 microgram twice daily in these instances and at the Investigator's discretion, further attempts at dose escalation may have been made.
10987197|NCT00989989|BG000|Baseline|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
10987198|NCT00989989|BG001|Baseline|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
10987199|NCT00989989|BG002|Baseline|Laser Control|Active laser treatment plus sham intravitreal injections.
10987200|NCT00989989|BG003|Baseline|Total|Total of all reporting groups
10987201|NCT00989989|FG000|Participant Flow|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
10987202|NCT00989989|FG001|Participant Flow|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
10987203|NCT00989989|FG002|Participant Flow|Laser Control|Active laser treatment plus sham intravitreal injections.
10987204|NCT00989989|OG000|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
10987205|NCT00989989|OG001|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
10987206|NCT00989989|OG002|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
10987207|NCT00989989|EG000|Reported Event|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
10987208|NCT00989989|EG001|Reported Event|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
10987209|NCT00989989|EG002|Reported Event|Laser Control|Active laser treatment plus sham intravitreal injections.
10987210|NCT00990093|BG000|Baseline|Entire Study Population|
10987211|NCT00990093|FG000|Participant Flow|A: First Test Catheter Then Standard Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
10987212|NCT00990093|FG001|Participant Flow|B: First Standard Catheter Then Test Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
10987213|NCT00990093|OG000|Outcome|Test Catheter|SpeediCath Compact Male Catheter
10987214|NCT00990093|OG001|Outcome|Standard Catheter|SpeediCath Catheter
10987215|NCT00990093|EG000|Reported Event|Test Catheter|SpeediCath Compact Male
10987216|NCT00990093|EG001|Reported Event|Standard Catheter|SpeediCath, CH 12 hydrophilic coated intermittent catheter
10987217|NCT00990106|BG000|Baseline|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
10987218|NCT00990106|BG001|Baseline|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
10987219|NCT00990106|BG002|Baseline|Total|Total of all reporting groups
10987220|NCT00990106|FG000|Participant Flow|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
10987221|NCT00990106|FG001|Participant Flow|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
10987222|NCT00990106|OG000|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
10987223|NCT00990106|OG001|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
10987224|NCT00990106|EG000|Reported Event|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
10987225|NCT00990106|EG001|Reported Event|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
10987226|NCT00990184|BG000|Baseline|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
10987227|NCT00990184|FG000|Participant Flow|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
10987228|NCT00990184|OG000|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline
10987229|NCT00990184|OG000|Outcome|Colesevelam 3.75 g Daily|Medication used to treat people with increased cholesterol levels
10987230|NCT00990184|OG000|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline (end of two week placebo run in period)
10987231|NCT00990184|EG000|Reported Event|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
10987232|NCT00990236|BG000|Baseline|Exoxaparin 30 mg BID|"standard dose enoxaparin thromboprophylaxis (30 mg twice daily)~Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID."
10987233|NCT00990236|BG001|Baseline|Enoxaparin Dose Adjusted Based on TEG|"enoxaparin dose modified based on TEG results~Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID."
10987234|NCT00990236|BG002|Baseline|Total|Total of all reporting groups
10987235|NCT00990236|FG000|Participant Flow|Exoxaparin 30 mg BID|"standard dose enoxaparin thromboprophylaxis (30 mg twice daily)~Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID."
10987236|NCT00990236|FG001|Participant Flow|Enoxaparin Dose Adjusted Based on TEG|"enoxaparin dose modified based on TEG results~Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID."
10987237|NCT00990236|OG000|Outcome|Exoxaparin 30 mg BID|"standard dose enoxaparin thromboprophylaxis (30 mg twice daily)~Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID."
10987238|NCT00990236|OG001|Outcome|Enoxaparin Dose Adjusted Based on TEG|"enoxaparin dose modified based on TEG results~Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID."
10987239|NCT00990236|EG000|Reported Event|Exoxaparin 30 mg BID|"standard dose enoxaparin thromboprophylaxis (30 mg twice daily)~Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID."
10987240|NCT00990236|EG001|Reported Event|Enoxaparin Dose Adjusted Based on TEG|"enoxaparin dose modified based on TEG results~Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID."
10987241|NCT00990249|BG000|Baseline|Busulfan + Clofarabine + Stem Cell Transplant|Busulfan test dose 32 mg/m^2 IV Day -8; following doses Days -6 to -3 derived from PK testing. Clofarabine 40 mg/m^2 IV daily Day -6 through Day -3. Thymoglobulin 0.5 mg/kg Day -3, 1.5 mg/kg Day -2 & 2.0 mg/kg Day -1 for HLA nonidentical or unrelated donors. Stem cell infusion on Day 0.
10987242|NCT00990249|FG000|Participant Flow|Busulfan + Clofarabine + Stem Cell Transplant|Busulfan test dose 32 mg/m^2 intravenous (IV) Day -8; following doses Days -6 to -3 derived from pharmacokinetic (PK) testing done up to 11 times over 11 hours after test dose. Clofarabine 40 mg/m^2 IV daily Day -6 through Day -3. Thymoglobulin 0.5 mg/kg Day -3, 1.5 mg/kg Day -2 & 2.0 mg/kg Day -1 for HLA nonidentical or unrelated donors. Stem cell infusion on Day 0.
10987243|NCT00990249|OG000|Outcome|Busulfan + Clofarabine + Stem Cell Transplant|Busulfan test dose 32 mg/m^2 IV Day -8; following doses Days -6 to -3 derived from PK testing. Clofarabine 40 mg/m^2 IV daily Day -6 through Day -3. Thymoglobulin 0.5 mg/kg Day -3, 1.5 mg/kg Day -2 & 2.0 mg/kg Day -1 for HLA nonidentical or unrelated donors. Stem cell infusion on Day 0.
11348178|NCT04205669|BG001|Baseline|Household Treatment|Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
10987244|NCT00990249|EG000|Reported Event|Busulfan + Clofarabine + Stem Cell Transplant|Busulfan test dose 32 mg/m^2 IV Day -8; following doses Days -6 to -3 derived from PK testing. Clofarabine 40 mg/m^2 IV daily Day -6 through Day -3. Thymoglobulin 0.5 mg/kg Day -3, 1.5 mg/kg Day -2 & 2.0 mg/kg Day -1 for HLA nonidentical or unrelated donors. Stem cell infusion on Day 0.
10987245|NCT00990288|BG000|Baseline|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
10987246|NCT00990288|BG001|Baseline|Control|No intervention.
10987247|NCT00990288|BG002|Baseline|Total|Total of all reporting groups
10987248|NCT00990288|FG000|Participant Flow|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
10987249|NCT00990288|FG001|Participant Flow|Control|No intervention.
10987250|NCT00990288|OG000|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
10987251|NCT00990288|OG001|Outcome|Control|No intervention.
10987252|NCT00990288|EG000|Reported Event|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
10987253|NCT00990288|EG001|Reported Event|Control|No intervention.
10987254|NCT00990314|BG000|Baseline|Beraprost Sodium|Beraprost Sodium Modified Release Tablet, 60 micrograms(mcg), twice a day dosing
10987255|NCT00990314|FG000|Participant Flow|Beraprost Sodium|Beraprost Sodium Modified Release Tablet, 60 micrograms(mcg), twice a day dosing
10987256|NCT00990314|OG000|Outcome|Beraprost Sodium|Beraprost Sodium Modified Release Tablet, 60 micrograms(mcg), twice a day dosing
10987257|NCT00990314|EG000|Reported Event|Beraprost Sodium|Beraprost Sodium Modified Release Tablet, 60 micrograms(mcg), twice a day dosing
10987258|NCT00990340|BG000|Baseline|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
10987259|NCT00990340|BG001|Baseline|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
10987260|NCT00990340|BG002|Baseline|Total|Total of all reporting groups
10987261|NCT00990340|FG000|Participant Flow|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
10987262|NCT00990340|FG001|Participant Flow|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
10987263|NCT00990340|OG000|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
10987264|NCT00990340|OG001|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
10987265|NCT00990340|OG000|Outcome|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
10987266|NCT00990340|OG001|Outcome|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
10987267|NCT00990340|EG000|Reported Event|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
10987268|NCT00990340|EG001|Reported Event|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
10987269|NCT00990509|BG000|Baseline|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
10987270|NCT00990509|BG001|Baseline|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
10987271|NCT00990509|BG002|Baseline|Total|Total of all reporting groups
10987272|NCT00990509|FG000|Participant Flow|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
10987273|NCT00990509|FG001|Participant Flow|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
10987274|NCT00990509|OG000|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
10987275|NCT00990509|OG001|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
10987276|NCT00990509|EG000|Reported Event|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
11348179|NCT04205669|BG002|Baseline|Total|Total of all reporting groups
11348180|NCT04205669|FG000|Participant Flow|Individual Treatment|Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
10987277|NCT00990509|EG001|Reported Event|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
10987278|NCT00990561|BG000|Baseline|Ultravate Twice a Day|
10987279|NCT00990561|BG001|Baseline|Ultravate Once a Day|Ultravate ointment applied once daily
10987280|NCT00990561|BG002|Baseline|Total|Total of all reporting groups
10987281|NCT00990561|FG000|Participant Flow|Twice Daily Topical Ultravate Ointment + LacHyrin Twice Daily|
10987282|NCT00990561|FG001|Participant Flow|Once Daily Topical Ultravate Ointment + LacHydrin Lotion|
10987283|NCT00990561|FG002|Participant Flow|Lac-Hydrin Topically Twice a Day|
10987284|NCT00990561|FG003|Participant Flow|No Treatment|
10987285|NCT00990561|OG000|Outcome|Ultravate 0.05% Ointment Twice Daily|Ultravate twice daily to affected area.
10987286|NCT00990561|OG001|Outcome|Ultravate 0.05% Ointment Once Daily|Ultravate one daily to affected area.
10987287|NCT00990561|EG000|Reported Event|Ultravate Twice a Day|
10987288|NCT00990561|EG001|Reported Event|Ultravate Once a Day|Ultravate ointment applied once daily
10987289|NCT00990652|BG000|Baseline|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
10987290|NCT00990652|FG000|Participant Flow|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
10987291|NCT00990652|OG000|Outcome|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
10987292|NCT00990652|OG000|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
10987293|NCT00990652|EG000|Reported Event|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
10987294|NCT00990665|BG000|Baseline|CRT-D and LV Lead|CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
10987295|NCT00990665|FG000|Participant Flow|CRT-D and LV Lead|CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
10987296|NCT00990665|OG000|Outcome|CRT-D and LV Lead|CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
10987297|NCT00990665|OG000|Outcome|Patients Per Statistical Analysis Plan|Total number of participants enrolled in the study (with an attempted implant of a Promote Q CRT-D and Quartet LV lead including unsuccessful implants).
10987298|NCT00990665|OG001|Outcome|Patients Per Complete Case Analysis|Complete case analysis includes only the number of patients that were successfully implanted with the Promote Q CRT-D and Quartet LV lead.
10987299|NCT00990665|EG000|Reported Event|CRT-D and LV Lead|CRT-D and LV Lead
10987300|NCT00990704|BG000|Baseline|Paricalcitol|2 mcg with incremental of 1 mcg
10987301|NCT00990704|BG001|Baseline|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
10987302|NCT00990704|BG002|Baseline|Total|Total of all reporting groups
10987303|NCT00990704|FG000|Participant Flow|Paricalcitol|2 mcg with incremental of 1 mcg
10987304|NCT00990704|FG001|Participant Flow|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
10987305|NCT00990704|OG000|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
10987306|NCT00990704|OG001|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
10987307|NCT00990704|EG000|Reported Event|Paricalcitol|2 mcg with incremental of 1 mcg
10987308|NCT00990704|EG001|Reported Event|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
10987309|NCT00990769|BG000|Baseline|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
10987310|NCT00990769|BG001|Baseline|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
10987311|NCT00990769|BG002|Baseline|Total|Total of all reporting groups
10987312|NCT00990769|FG000|Participant Flow|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
10987313|NCT00990769|FG001|Participant Flow|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
10987314|NCT00990769|OG000|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
10987315|NCT00990769|OG001|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
10987316|NCT00990769|EG000|Reported Event|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
10987317|NCT00990769|EG001|Reported Event|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
10987318|NCT00990782|BG000|Baseline|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
10987319|NCT00990782|FG000|Participant Flow|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
10987320|NCT00990782|OG000|Outcome|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
10987321|NCT00990782|EG000|Reported Event|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
10987322|NCT00990821|BG000|Baseline|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
10987323|NCT00990821|BG001|Baseline|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
10987324|NCT00990821|BG002|Baseline|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
10987325|NCT00990821|BG003|Baseline|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
10987326|NCT00990821|BG004|Baseline|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
10987327|NCT00990821|BG005|Baseline|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
10987328|NCT00990821|BG006|Baseline|Part III, Panel 2|40 mg MK-0517 (non-PS80)
10987329|NCT00990821|BG007|Baseline|Part IV|40 mg MK-0517 (non-PS80 formulation)
10987330|NCT00990821|BG008|Baseline|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
10987331|NCT00990821|BG009|Baseline|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
10987332|NCT00990821|BG010|Baseline|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
10987333|NCT00990821|BG011|Baseline|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
10987334|NCT00990821|BG012|Baseline|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
10987335|NCT00990821|BG013|Baseline|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
10987336|NCT00990821|BG014|Baseline|Total|Total of all reporting groups
10987337|NCT00990821|FG000|Participant Flow|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
10987338|NCT00990821|FG001|Participant Flow|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
10987339|NCT00990821|FG002|Participant Flow|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
10987340|NCT00990821|FG003|Participant Flow|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
10987341|NCT00990821|FG004|Participant Flow|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
10987342|NCT00990821|FG005|Participant Flow|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
10987343|NCT00990821|FG006|Participant Flow|Part III, Panel 2|40 mg MK-0517 (non-PS80)
10987344|NCT00990821|FG007|Participant Flow|Part IV|40 mg MK-0517 (non-PS80 formulation)
10987345|NCT00990821|FG008|Participant Flow|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
10987346|NCT00990821|FG009|Participant Flow|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
10987347|NCT00990821|FG010|Participant Flow|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
10987348|NCT00990821|FG011|Participant Flow|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
10987349|NCT00990821|FG012|Participant Flow|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
10987350|NCT00990821|FG013|Participant Flow|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
10987351|NCT00990821|OG000|Outcome|Aprepitant (125 mg)|A single oral dose with an Aprepitant capsule
10987352|NCT00990821|OG001|Outcome|MK-0517 (100 mg)|100 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
10987353|NCT00990821|OG002|Outcome|MK-0517 (115 mg)|115 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
10987354|NCT00990821|EG000|Reported Event|90 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
10987355|NCT00990821|EG001|Reported Event|100 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
10987356|NCT00990821|EG002|Reported Event|100 mg MK-0517 (PS80) + 2 mg Midazolam|PS80 formulation, administered with a single IV administration and a single oral administration of midazolam
10987357|NCT00990821|EG003|Reported Event|115 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
10987358|NCT00990821|EG004|Reported Event|150 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
10987359|NCT00990821|EG005|Reported Event|40 mg MK-0517 (Non-PS80)|MK-0517, non-PS80 formulation, administered with a single IV administration
10987360|NCT00990821|EG006|Reported Event|100 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
10987361|NCT00990821|EG007|Reported Event|150 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
10987362|NCT00990821|EG008|Reported Event|Placebo|Placebo matching MK-0517 (PS80 or non-PS80)
10987363|NCT00990821|EG009|Reported Event|40 mg Aprepitant|Aprepitant administered by a single oral capsule
10987364|NCT00990821|EG010|Reported Event|125 mg Aprepitant|Aprepitant administered as a single oral capsule
10987365|NCT00990821|EG011|Reported Event|2 mg Midazolam|Midazolam administered as a single oral solution
10987366|NCT00990938|BG000|Baseline|Placebo + Ribavirin|Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
10987367|NCT00990938|BG001|Baseline|IMO-2125 0.08 mg/kg Weekly + Ribavirin|First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987368|NCT00990938|BG002|Baseline|IMO-2125 0.16 mg/kg Weekly + Ribavirin|Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987369|NCT00990938|BG003|Baseline|IMO-2125 0.32 mg/kg Weekly + Ribavirin|Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987370|NCT00990938|BG004|Baseline|IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin|Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987371|NCT00990938|BG005|Baseline|Peg-rIFN + Ribavirin|Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
10987372|NCT00990938|BG006|Baseline|Total|Total of all reporting groups
10987373|NCT00990938|FG000|Participant Flow|Placebo + Ribavirin|Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
10987374|NCT00990938|FG001|Participant Flow|IMO-2125 0.08 mg/kg Weekly + Ribavirin|First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987375|NCT00990938|FG002|Participant Flow|IMO-2125 0.16 mg/kg Weekly + Ribavirin|Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987376|NCT00990938|FG003|Participant Flow|IMO-2125 0.32 mg/kg Weekly + Ribavirin|Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987377|NCT00990938|FG004|Participant Flow|IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin|Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987378|NCT00990938|FG005|Participant Flow|Peg-rIFN + Ribavirin|Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
10987379|NCT00990938|OG000|Outcome|Placebo + Ribavirin|Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
10987380|NCT00990938|OG001|Outcome|IMO-2125 0.08 mg/kg Weekly + Ribavirin|First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987381|NCT00990938|OG002|Outcome|IMO-2125 0.16 mg/kg Weekly + Ribavirin|Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987382|NCT00990938|OG003|Outcome|IMO-2125 0.32 mg/kg Weekly + Ribavirin|Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987383|NCT00990938|OG004|Outcome|IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin|Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987384|NCT00990938|OG005|Outcome|Peg-rIFN + Ribavirin|Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
10987385|NCT00990938|EG000|Reported Event|Placebo + Ribavirin|Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
10987386|NCT00990938|EG001|Reported Event|IMO-2125 0.08 mg/kg Weekly + Ribavirin|First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987387|NCT00990938|EG002|Reported Event|IMO-2125 0.16 mg/kg Weekly + Ribavirin|Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
11348181|NCT04205669|FG001|Participant Flow|Household Treatment|Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
10987388|NCT00990938|EG003|Reported Event|IMO-2125 0.32 mg/kg Weekly + Ribavirin|Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987389|NCT00990938|EG004|Reported Event|IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin|Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
10987390|NCT00990938|EG005|Reported Event|Peg-rIFN + Ribavirin|Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
10987391|NCT00990964|BG000|Baseline|Attain Family Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
10987392|NCT00990964|FG000|Participant Flow|Attain Family Left Heart Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
10987393|NCT00990964|OG000|Outcome|Attain Family Lead and Catheter Attempt|Subjects who were attempted with an Attain Family left-heart lead after successful coronary sinus (CS) cannulation with an Attain Family catheter were included in this analysis as well as subjects who had unsuccessful CS cannulation with an Attain Family delivery catheter.
10987394|NCT00990964|OG000|Outcome|Attain Family Lead Attempt, Any Catheter|Subjects who were attempted with Attain Family delivery catheters or Attain Family left-heart leads were included in this analysis.
10987395|NCT00990964|EG000|Reported Event|Attain Family Lead|All new and/or worsening adverse events related to the left-heart leads and left-heart lead delivery catheters were collected through the 3 month visit. Event collection started once the subject enrolled in the study and underwent a left-heart lead implant attempt.
10987396|NCT00991029|BG000|Baseline|Clopidogrel|"Patients assigned to clopidogrel in addition to aspirin~Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days"
10987397|NCT00991029|BG001|Baseline|Placebo|"Patients assigned to placebo in addition to aspirin~placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days"
10987398|NCT00991029|BG002|Baseline|Total|Total of all reporting groups
10987399|NCT00991029|FG000|Participant Flow|Clopidogrel|"Patients assigned to clopidogrel in addition to aspirin~Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days"
10987400|NCT00991029|FG001|Participant Flow|Placebo|"Patients assigned to placebo in addition to aspirin~placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days"
10987401|NCT00991029|OG000|Outcome|Clopidogrel|"Patients assigned to clopidogrel in addition to aspirin~Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days"
10987402|NCT00991029|OG001|Outcome|Placebo|"Patients assigned to placebo in addition to aspirin~placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days"
10987403|NCT00991029|EG000|Reported Event|Clopidogrel|"Patients assigned to clopidogrel in addition to aspirin~Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days"
10987404|NCT00991029|EG001|Reported Event|Placebo|"Patients assigned to placebo in addition to aspirin~placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days"
10987405|NCT00991081|BG000|Baseline|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
10987406|NCT00991081|BG001|Baseline|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
10987407|NCT00991081|BG002|Baseline|Total|Total of all reporting groups
10987408|NCT00991081|FG000|Participant Flow|Formative Interviews|"Phase 1 involved formative research to develop and refine a patient-centered, theoretically grounded behavioral intervention for delivering genetically-tailored smoking cessation treatment. We convened a panel of doctorate level experts (n = 10) in pharmacogenetics; smoking cessation treatment; ethical, legal and social implications of genetics research; genetic literacy; patient-clinician communications; and mixed-methods research to guide development of the pharmacogenetic treatment, GF and evaluation.~Next, smokers were asked about their familiarity with genetic concepts (e.g., DNA, genes), understanding of the roles genes play in smoking behavior and treatment response, reaction to the concept of genetically-tailoring pharmacotherapy, familiarity with the Genetic Information Nondiscrimination Act, concerns about privacy of genetic information, and interest in genetically-tailored treatment. Interviews were continued until response saturation was achieved (n = 10)."
10987409|NCT00991081|FG001|Participant Flow|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
10987410|NCT00991081|FG002|Participant Flow|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
10987411|NCT00991081|OG000|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
10987412|NCT00991081|OG001|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
10987413|NCT00991081|EG000|Reported Event|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
10987414|NCT00991081|EG001|Reported Event|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
10987415|NCT00991185|BG000|Baseline|Vancomycin|children that received vancomycin per standard of care
10987416|NCT00991185|FG000|Participant Flow|Vancomycin|children that received vancomycin per standard of care
10987417|NCT00991185|OG000|Outcome|Vancomycin|children that received vancomycin per standard of care
10987418|NCT00991185|EG000|Reported Event|Vancomycin|children that received vancomycin per standard of care
11007288|NCT01090102|OG000|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
10987419|NCT00991276|BG000|Baseline|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987420|NCT00991276|BG001|Baseline|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987421|NCT00991276|BG002|Baseline|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987422|NCT00991276|BG003|Baseline|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987423|NCT00991276|BG004|Baseline|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987424|NCT00991276|BG005|Baseline|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987425|NCT00991276|BG006|Baseline|Total|Total of all reporting groups
10987426|NCT00991276|FG000|Participant Flow|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987427|NCT00991276|FG001|Participant Flow|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987428|NCT00991276|FG002|Participant Flow|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987429|NCT00991276|FG003|Participant Flow|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987430|NCT00991276|FG004|Participant Flow|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987431|NCT00991276|FG005|Participant Flow|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
10987432|NCT00991276|OG000|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
10987433|NCT00991276|OG001|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
10987434|NCT00991276|OG002|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
10987435|NCT00991276|OG002|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily in any intervention period.
10987436|NCT00991276|EG000|Reported Event|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
10987437|NCT00991276|EG001|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
10987438|NCT00991276|EG002|Reported Event|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in any of the intervention period.
10987439|NCT00991289|BG000|Baseline|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
10987440|NCT00991289|FG000|Participant Flow|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
10987441|NCT00991289|OG000|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
10987442|NCT00991289|EG000|Reported Event|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
10987443|NCT00991302|BG000|Baseline|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
10987444|NCT00991302|BG001|Baseline|Standard Care|Participants received standard care.
10987445|NCT00991302|BG002|Baseline|Total|Total of all reporting groups
10987446|NCT00991302|FG000|Participant Flow|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
10987447|NCT00991302|FG001|Participant Flow|Standard Care|Participants received standard care.
10987448|NCT00991302|OG000|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
10987449|NCT00991302|OG001|Outcome|Standard Care|Participants received standard care.
10987450|NCT00991302|EG000|Reported Event|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
10987451|NCT00991302|EG001|Reported Event|Standard Care|Participants received standard care.
10987452|NCT00991341|BG000|Baseline|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
10987453|NCT00991341|BG001|Baseline|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
10987454|NCT00991341|BG002|Baseline|Total|Total of all reporting groups
10987455|NCT00991341|FG000|Participant Flow|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
10987456|NCT00991341|FG001|Participant Flow|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
10987457|NCT00991341|OG000|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
10987458|NCT00991341|OG001|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
10987459|NCT00991341|EG000|Reported Event|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
10987460|NCT00991341|EG001|Reported Event|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
10987461|NCT00991406|BG000|Baseline|Arm 1: FES|"Case-control study: pre- and post-stimulation (FES).~FES: Surface stimulation to contract the muscles in the lower extremity where subjects serve as their own control."
10846473|NCT00276380|OG000|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
10987462|NCT00991406|FG000|Participant Flow|Arm 1: FES|"Case-control study: pre- and post-stimulation (FES).~FES: Surface stimulation to contract the muscles in the lower extremity"
10987463|NCT00991406|OG000|Outcome|Arm 1: FES|"Case-control study: pre- and post-stimulation (FES).~FES: Surface stimulation to contract the muscles in the lower extremity"
10987464|NCT00991406|EG000|Reported Event|Arm 1: FES|"Case-control study: pre- and post-stimulation (FES).~FES: Surface stimulation to contract the muscles in the lower extremity where subjects serve as their own control."
10987465|NCT00991458|BG000|Baseline|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987466|NCT00991458|BG001|Baseline|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987467|NCT00991458|BG002|Baseline|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987468|NCT00991458|BG003|Baseline|Total|Total of all reporting groups
10987469|NCT00991458|FG000|Participant Flow|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987470|NCT00991458|FG001|Participant Flow|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987471|NCT00991458|FG002|Participant Flow|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987472|NCT00991458|OG000|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987473|NCT00991458|OG001|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987474|NCT00991458|OG002|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987475|NCT00991458|EG000|Reported Event|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987476|NCT00991458|EG001|Reported Event|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987477|NCT00991458|EG002|Reported Event|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
10987478|NCT00991510|BG000|Baseline|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
10987479|NCT00991510|BG001|Baseline|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
10987480|NCT00991510|BG002|Baseline|Total|Total of all reporting groups
10987481|NCT00991510|FG000|Participant Flow|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
10987482|NCT00991510|FG001|Participant Flow|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
10987483|NCT00991510|OG000|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
10987484|NCT00991510|OG001|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
10987485|NCT00991510|OG000|Outcome|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
10987486|NCT00991510|OG001|Outcome|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
10987487|NCT00991510|OG002|Outcome|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
10987488|NCT00991510|EG000|Reported Event|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
10987489|NCT00991510|EG001|Reported Event|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
10987490|NCT00991510|EG002|Reported Event|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
10987491|NCT00991809|BG000|Baseline|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
10987492|NCT00991809|BG001|Baseline|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
10987493|NCT00991809|BG002|Baseline|Total|Total of all reporting groups
10987494|NCT00991809|FG000|Participant Flow|Alfentanil|"Subjects received a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg intramuscular(IM)"
10987495|NCT00991809|FG001|Participant Flow|Diphenhydramine|"Subjects received a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
10987496|NCT00991809|OG000|Outcome|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
10987497|NCT00991809|OG001|Outcome|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
10987498|NCT00991809|OG000|Outcome|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil: 15 mcg/kg IM"
10987499|NCT00991809|OG001|Outcome|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine: 25 mg IM"
10987500|NCT00991809|EG000|Reported Event|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
10987501|NCT00991809|EG001|Reported Event|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
10987502|NCT00991939|BG000|Baseline|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
10987503|NCT00991939|BG001|Baseline|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
10987504|NCT00991939|BG002|Baseline|Total|Total of all reporting groups
10987505|NCT00991939|FG000|Participant Flow|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
11007289|NCT01090102|OG001|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
10987506|NCT00991939|FG001|Participant Flow|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
10987507|NCT00991939|OG000|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
10987508|NCT00991939|OG001|Outcome|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
10987509|NCT00991939|OG000|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
10987510|NCT00991939|OG001|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
10987511|NCT00991939|EG000|Reported Event|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
10987512|NCT00991939|EG001|Reported Event|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
10987513|NCT00991952|BG000|Baseline|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
10987514|NCT00991952|BG001|Baseline|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
10987515|NCT00991952|BG002|Baseline|Total|Total of all reporting groups
10987516|NCT00991952|FG000|Participant Flow|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
10987517|NCT00991952|FG001|Participant Flow|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
10987518|NCT00991952|OG000|Outcome|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
10987519|NCT00991952|OG001|Outcome|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
10987520|NCT00991952|EG000|Reported Event|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
10987521|NCT00991952|EG001|Reported Event|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
10987522|NCT00992017|BG000|Baseline|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
10987523|NCT00992017|FG000|Participant Flow|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
10987524|NCT00992017|OG000|Outcome|H1N1 Vaccine|Pregnant women enrolled in the study.
10987525|NCT00992017|OG000|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
10987526|NCT00992017|OG000|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
10987527|NCT00992017|OG000|Outcome|H1N1 Vaccine|Pregnant women who received H1N1 vaccinations.
10987528|NCT00992017|OG000|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
10987529|NCT00992017|OG000|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
10987530|NCT00992017|EG000|Reported Event|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
10987531|NCT00992056|BG000|Baseline|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then Nebivolol 5 mg titrated to 10 mg
10987532|NCT00992056|BG001|Baseline|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50 mg titrated to 100 mg
10987533|NCT00992056|BG002|Baseline|Total|Total of all reporting groups
10987534|NCT00992056|FG000|Participant Flow|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50mg titrated to 100 mg.
10987535|NCT00992056|FG001|Participant Flow|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then nebivolol 5 mg titrated to 10 mg
10987536|NCT00992056|OG000|Outcome|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
10987537|NCT00992056|OG001|Outcome|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
10987538|NCT00992056|EG000|Reported Event|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
10987539|NCT00992056|EG001|Reported Event|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
10987540|NCT00992108|BG000|Baseline|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
10987541|NCT00992108|BG001|Baseline|Botulinum|chemodenervation: botulinum toxin
10987542|NCT00992108|BG002|Baseline|Total|Total of all reporting groups
10987543|NCT00992108|FG000|Participant Flow|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
10987544|NCT00992108|FG001|Participant Flow|Botulinum|chemodenervation: botulinum toxin
10987545|NCT00992108|OG000|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
10987546|NCT00992108|OG001|Outcome|Botulinum|chemodenervation: botulinum toxin
10987547|NCT00992108|EG000|Reported Event|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
10987548|NCT00992108|EG001|Reported Event|Botulinum|chemodenervation: botulinum toxin
10987549|NCT00992186|BG000|Baseline|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
10987550|NCT00992186|FG000|Participant Flow|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
10987551|NCT00992186|OG000|Outcome|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
10987552|NCT00992186|OG000|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
10987553|NCT00992186|EG000|Reported Event|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
10987554|NCT00992225|BG000|Baseline|LY573636-sodium|Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
10987555|NCT00992225|FG000|Participant Flow|LY573636-sodium|Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
10987556|NCT00992225|OG000|Outcome|LY573636-sodium|Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
10987557|NCT00992225|EG000|Reported Event|LY573636-sodium|Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
10987558|NCT00992264|BG000|Baseline|Randomization Arm: 1|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [yes].
10987559|NCT00992264|BG001|Baseline|Radndomization Arm: 2|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
10987560|NCT00992264|BG002|Baseline|Randomization Arm: 3|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [yes].
10987561|NCT00992264|BG003|Baseline|Randomization Arm: 4|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [yes].
10987562|NCT00992264|BG004|Baseline|Randomization Arm: 5|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [no].
10987563|NCT00992264|BG005|Baseline|Randomization Arm: 6|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [no].
10987564|NCT00992264|BG006|Baseline|Randomization Arm: 7|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [no].
10987565|NCT00992264|BG007|Baseline|Randomization Arm: 8|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [no].
10987566|NCT00992264|BG008|Baseline|Randomization Arm: 9|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [yes].
10987567|NCT00992264|BG009|Baseline|Randomization Arm: 10|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
10987568|NCT00992264|BG010|Baseline|Randomization Arm: 11|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [yes].
10987569|NCT00992264|BG011|Baseline|Randomization Arm: 12|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [yes].
10987570|NCT00992264|BG012|Baseline|Randomization Arm: 13|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [no].
10987571|NCT00992264|BG013|Baseline|Randomization Arm: 14|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [no].
10987572|NCT00992264|BG014|Baseline|Randomization Arm: 15|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [no].
10987573|NCT00992264|BG015|Baseline|Randomization Arm: 16|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [no].
10987574|NCT00992264|BG016|Baseline|Total|Total of all reporting groups
10987575|NCT00992264|FG000|Participant Flow|Randomization Arm 1|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [yes]
10987576|NCT00992264|FG001|Participant Flow|Randomization Arm 2|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [yes]
10987577|NCT00992264|FG002|Participant Flow|Randomization Arm 3|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [yes]
10987578|NCT00992264|FG003|Participant Flow|Randomization Arm 4|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [yes]
10987579|NCT00992264|FG004|Participant Flow|Randomization Arm 5|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [no]
10987580|NCT00992264|FG005|Participant Flow|Randomization Arm 6|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [no]
10987581|NCT00992264|FG006|Participant Flow|Randomization Arm 7|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [no]
10987582|NCT00992264|FG007|Participant Flow|Randomization Arm 8|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [no]
10987583|NCT00992264|FG008|Participant Flow|Randomization Arm 9|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [yes]
10987584|NCT00992264|FG009|Participant Flow|Randomization Arm 10|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [yes]
10987585|NCT00992264|FG010|Participant Flow|Randomization Arm 11|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [yes]
10987586|NCT00992264|FG011|Participant Flow|Randomization Arm 12|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [yes]
10987587|NCT00992264|FG012|Participant Flow|Randomization Arm 13|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [no]
10987588|NCT00992264|FG013|Participant Flow|Randomization Arm 14|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [no]
10987589|NCT00992264|FG014|Participant Flow|Randomization Arm 15|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [no]
11007290|NCT01090102|EG000|Reported Event|Mesalamine|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth).
10987590|NCT00992264|FG015|Participant Flow|Randomization Arm 16|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [no]
10987591|NCT00992264|OG000|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.~Persons in the comparison group received content written in a motivational message tone."
10987592|NCT00992264|OG001|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.~Persons in the comparison group did not receive the testimonial content."
10987593|NCT00992264|OG002|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.~Persons in the comparison group could freely navigate the website."
10987594|NCT00992264|OG003|Outcome|Proactive Outreach|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.~Persons in the comparison group did not receive proactive email reminders."
10987595|NCT00992264|OG003|Outcome|Proactive Emails|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.~Persons in the comparison group did not receive proactive email reminders."
10987596|NCT00992264|EG000|Reported Event|Message Tone|"Prescriptive or Motivational~Persons are randomized to receive intervention content written in either a prescriptive or motivational tone."
10987597|NCT00992264|EG001|Reported Event|Testimonials|"Testimonial or No Testimonial~Persons are randomized to receive a personally tailored testimonial or not."
10987598|NCT00992264|EG002|Reported Event|Navigation|"Dictated or Non-Dictated~Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking."
10987599|NCT00992264|EG003|Reported Event|Proactive Outreach|"Email or No-Email communication~Persons are randomized to receive periodic email reminders to return to the intervention website or not."
10987600|NCT00992394|BG000|Baseline|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
10987601|NCT00992394|BG001|Baseline|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
10987602|NCT00992394|BG002|Baseline|Total|Total of all reporting groups
10987603|NCT00992394|FG000|Participant Flow|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
10987604|NCT00992394|FG001|Participant Flow|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
10987605|NCT00992394|OG000|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
10987606|NCT00992394|OG001|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
10987607|NCT00992394|EG000|Reported Event|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
10987608|NCT00992394|EG001|Reported Event|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
10987609|NCT00992407|BG000|Baseline|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
10987610|NCT00992407|BG001|Baseline|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
10987611|NCT00992407|BG002|Baseline|Total|Total of all reporting groups
10987612|NCT00992407|FG000|Participant Flow|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
10987613|NCT00992407|FG001|Participant Flow|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
10987614|NCT00992407|OG000|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
10987615|NCT00992407|OG001|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
10987616|NCT00992407|OG001|Outcome|Risperidone Tablet|Risperidone tablet were administered orally as 0.5-10 mg daily up to Week 52.
10987617|NCT00992407|OG000|Outcome|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
10987618|NCT00992407|OG001|Outcome|Risperidone Tablet|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
10987619|NCT00992407|EG000|Reported Event|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
10987620|NCT00992407|EG001|Reported Event|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
10987621|NCT00992433|BG000|Baseline|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
10987622|NCT00992433|BG001|Baseline|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
10987623|NCT00992433|BG002|Baseline|Total|Total of all reporting groups
10987624|NCT00992433|FG000|Participant Flow|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
10987625|NCT00992433|FG001|Participant Flow|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
10987626|NCT00992433|OG000|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
10987627|NCT00992433|OG001|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
10987628|NCT00992433|EG000|Reported Event|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
10987629|NCT00992433|EG001|Reported Event|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
10987630|NCT00992446|BG000|Baseline|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
10987631|NCT00992446|FG000|Participant Flow|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
10987632|NCT00992446|OG000|Outcome|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
10987633|NCT00992446|EG000|Reported Event|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
10987634|NCT00992459|BG000|Baseline|Treatment Arm A|Patients randomized to receive NaPBA + HPN 100 placebo for 2 weeks (Treatment Period 1) followed by HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 2)
10987635|NCT00992459|BG001|Baseline|Treatment Arm B|Patients randomized to receive HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 1) followed by NaPBA + HPN-100 placebo for 2 weeks (Treatment Period 2)
10987636|NCT00992459|BG002|Baseline|Total|Total of all reporting groups
10987637|NCT00992459|FG000|Participant Flow|Arm A|Subjects in Arm A were assigned to receive NaPBA + HPN 100 placebo for 2 weeks All patients in Arm A received HPN100 placebo (+ concomitant active NaPBA)
10987638|NCT00992459|FG001|Participant Flow|Arm B|Subjects in Arm B were assigned to receive HPN-100 + NaPBA placebo for 2 weeks All patients in Arm B received NaPBA placebo (+ concomitant active HPN 100)
10987639|NCT00992459|OG000|Outcome|NaPBA|Patients treated with NaPBA
10987640|NCT00992459|OG001|Outcome|HPN-100|Patients treated with HPN-100
10987641|NCT00992459|EG000|Reported Event|NaPBA|Patients received NaPBA
10987642|NCT00992459|EG001|Reported Event|HPN-100|Patients received HPN-100
10987643|NCT00992511|BG000|Baseline|GSK2340272A New 1D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
11007291|NCT01090102|EG001|Reported Event|Placebo|Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth).
10987644|NCT00992511|BG001|Baseline|GSK2340272A New 2D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987645|NCT00992511|BG002|Baseline|GSK2340272A INI 1D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10987646|NCT00992511|BG003|Baseline|GSK2340272A INI 2D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987647|NCT00992511|BG004|Baseline|Total|Total of all reporting groups
10987648|NCT00992511|FG000|Participant Flow|GSK2340272A New 1D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10987649|NCT00992511|FG001|Participant Flow|GSK2340272A New 2D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987650|NCT00992511|FG002|Participant Flow|GSK2340272A INI 1D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10987651|NCT00992511|FG003|Participant Flow|GSK2340272A INI 2D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987652|NCT00992511|OG000|Outcome|GSK2340272A New 1D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10987653|NCT00992511|OG001|Outcome|GSK2340272A New 2D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987654|NCT00992511|OG002|Outcome|GSK2340272A INI 1D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10987655|NCT00992511|OG003|Outcome|GSK2340272A INI 2D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987656|NCT00992511|EG000|Reported Event|GSK2340272A New 1D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10987657|NCT00992511|EG001|Reported Event|GSK2340272A New 2D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987658|NCT00992511|EG002|Reported Event|GSK2340272A INI 1D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
10987659|NCT00992511|EG003|Reported Event|GSK2340272A INI 2D Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
10987660|NCT00992589|BG000|Baseline|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
10987661|NCT00992589|FG000|Participant Flow|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
10987662|NCT00992589|FG001|Participant Flow|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
10987663|NCT00992589|FG002|Participant Flow|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
10987664|NCT00992589|FG003|Participant Flow|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
10987665|NCT00992589|OG000|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
10987666|NCT00992589|OG001|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
10987667|NCT00992589|OG002|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
10987668|NCT00992589|OG003|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
10987669|NCT00992589|OG000|Outcome|Double-Blind Placebo - Baseline|Matching placebo capsules once daily in the morning.
10987670|NCT00992589|OG001|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
10987671|NCT00992589|OG002|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
10987672|NCT00992589|OG003|Outcome|Double-Blind Placebo - Week 8|Matching placebo capsules once daily in the morning.
10987673|NCT00992589|OG004|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
10987674|NCT00992589|OG005|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
10987675|NCT00992589|OG006|Outcome|Double-Blind Rabeprazole Sodium Total - Baseline|Rabeprazole Sodium capsules once daily in the morning.
10987676|NCT00992589|OG007|Outcome|Double-Blind Rabeprazole Sodium Total - Week 8|Rabeprazole Sodium capsules once daily in the morning.
10987677|NCT00992589|EG000|Reported Event|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
10987678|NCT00992589|EG001|Reported Event|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
10987679|NCT00992589|EG002|Reported Event|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
10987680|NCT00992589|EG003|Reported Event|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
10987681|NCT00992602|BG000|Baseline|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
10987682|NCT00992602|FG000|Participant Flow|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
10987683|NCT00992602|OG000|Outcome|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
10987684|NCT00992602|EG000|Reported Event|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
10987685|NCT00992719|BG000|Baseline|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987686|NCT00992719|BG001|Baseline|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987687|NCT00992719|BG002|Baseline|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987688|NCT00992719|BG003|Baseline|Total|Total of all reporting groups
10987689|NCT00992719|FG000|Participant Flow|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987690|NCT00992719|FG001|Participant Flow|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987691|NCT00992719|FG002|Participant Flow|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987692|NCT00992719|OG000|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987693|NCT00992719|OG001|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987694|NCT00992719|OG002|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987695|NCT00992719|EG000|Reported Event|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987696|NCT00992719|EG001|Reported Event|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987697|NCT00992719|EG002|Reported Event|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
10987698|NCT00992784|BG000|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
10987699|NCT00992784|BG001|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
10987700|NCT00992784|BG002|Baseline|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
10987701|NCT00992784|BG003|Baseline|Total|Total of all reporting groups
10987702|NCT00992784|FG000|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
10987703|NCT00992784|FG001|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
10987704|NCT00992784|FG002|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
10987705|NCT00992784|OG000|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
10987706|NCT00992784|OG001|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
10987707|NCT00992784|OG002|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
10987708|NCT00992784|EG000|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
10987709|NCT00992784|EG001|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
10987710|NCT00992784|EG002|Reported Event|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
10987711|NCT00992836|BG000|Baseline|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
10987712|NCT00992836|FG000|Participant Flow|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
10987713|NCT00992836|OG000|Outcome|All Study Participants|All 155 study participants are included in this analysis.
10987714|NCT00992836|OG000|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
10987715|NCT00992836|OG000|Outcome|Overall|The total N for these analyses were 140 and 142, for the analysis of antibody titers after the first and second vaccinations, respectively.
10987716|NCT00992836|OG000|Outcome|Overall|The total N for this analysis was 138, those who received both vaccinations and had nonmissing data.
10987717|NCT00992836|OG000|Outcome|Overall|The total N for these analyses were 140, 142 and 138, for the analysis of antibody titers after the first and second vaccinations and after 6 months after the second vaccination, respectively.
10987718|NCT00992836|OG000|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
10987719|NCT00992836|OG000|Outcome|Influenza A (H1N1) 2009 Monovalent Vaccine|"All participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart.~Influenza A (H1N1) 2009 monovalent vaccine: Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections"
10987720|NCT00992836|EG000|Reported Event|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
10987721|NCT00992927|BG000|Baseline|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
10987722|NCT00992927|BG001|Baseline|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
10987723|NCT00992927|BG002|Baseline|Total|Total of all reporting groups
10987724|NCT00992927|FG000|Participant Flow|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
10987725|NCT00992927|FG001|Participant Flow|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
10987726|NCT00992927|OG000|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
10987727|NCT00992927|OG001|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
10987728|NCT00992927|EG000|Reported Event|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
10987729|NCT00992927|EG001|Reported Event|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
10987730|NCT00992992|BG000|Baseline|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10987731|NCT00992992|FG000|Participant Flow|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10987732|NCT00992992|OG000|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
11007292|NCT01090180|BG000|Baseline|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
11007293|NCT01090180|BG001|Baseline|Arm 2: Placebo|Placebo (sugar pill): inactive
11007294|NCT01090180|BG002|Baseline|Total|Total of all reporting groups
11348182|NCT04205669|OG000|Outcome|Individual Treatment|Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
10987733|NCT00992992|EG000|Reported Event|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10987734|NCT00993031|BG000|Baseline|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987735|NCT00993031|BG001|Baseline|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987736|NCT00993031|BG002|Baseline|Total|Total of all reporting groups
10987737|NCT00993031|FG000|Participant Flow|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987738|NCT00993031|FG001|Participant Flow|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987739|NCT00993031|OG000|Outcome|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987740|NCT00993031|OG001|Outcome|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987741|NCT00993031|OG000|Outcome|Group A|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987742|NCT00993031|OG001|Outcome|Group B|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987743|NCT00993031|OG000|Outcome|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987744|NCT00993031|OG001|Outcome|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987745|NCT00993031|EG000|Reported Event|Group A|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987746|NCT00993031|EG001|Reported Event|Group B|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
10987747|NCT00993044|BG000|Baseline|Dose Level 1, 2|
10987748|NCT00993044|FG000|Participant Flow|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
10987749|NCT00993044|OG000|Outcome|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
10987750|NCT00993044|EG000|Reported Event|Dose Level 1|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5"
10987751|NCT00993044|EG001|Reported Event|Dose Level 2|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5"
10987752|NCT00993148|BG000|Baseline|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
10987753|NCT00993148|FG000|Participant Flow|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
10987754|NCT00993148|OG000|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
10987755|NCT00993148|EG000|Reported Event|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
10987756|NCT00993187|BG000|Baseline|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
10987757|NCT00993187|BG001|Baseline|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
10987758|NCT00993187|BG002|Baseline|Total|Total of all reporting groups
10987759|NCT00993187|FG000|Participant Flow|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
11007295|NCT01090180|FG000|Participant Flow|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
11007296|NCT01090180|FG001|Participant Flow|Arm 2: Placebo|Placebo (sugar pill): inactive
11348183|NCT04205669|OG001|Outcome|Household Treatment|Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
10875674|NCT00439218|BG000|Baseline|Subject Enrollments (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
10875675|NCT00439218|FG000|Participant Flow|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
10875676|NCT00439218|OG000|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
10875677|NCT00439218|EG000|Reported Event|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
10875678|NCT00439231|BG000|Baseline|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
10875679|NCT00439231|FG000|Participant Flow|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with CLL/SLL using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
10875680|NCT00439231|OG000|Outcome|CLL Subject Response Rate After Lenalidomide Therapy|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) using a 3 week on, 3 week off dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
10875681|NCT00439231|EG000|Reported Event|CLL Subjects Treated With Lenalidomide (Revlimid)|
10875682|NCT00439244|BG000|Baseline|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
10875683|NCT00439244|BG001|Baseline|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
10875684|NCT00439244|BG002|Baseline|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
10875685|NCT00439244|BG003|Baseline|Total|Total of all reporting groups
10875686|NCT00439244|FG000|Participant Flow|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
10875687|NCT00439244|FG001|Participant Flow|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
10875688|NCT00439244|FG002|Participant Flow|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
10987760|NCT00993187|FG001|Participant Flow|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
10875689|NCT00439244|OG000|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
10875690|NCT00439244|OG001|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
10875691|NCT00439244|OG002|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
10875692|NCT00439244|EG000|Reported Event|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
10875693|NCT00439244|EG001|Reported Event|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
10875694|NCT00439244|EG002|Reported Event|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
10875695|NCT00439270|BG000|Baseline|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875696|NCT00439270|BG001|Baseline|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875697|NCT00439270|BG002|Baseline|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875698|NCT00439270|BG003|Baseline|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875699|NCT00439270|BG004|Baseline|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875700|NCT00439270|BG005|Baseline|Total|Total of all reporting groups
10875701|NCT00439270|FG000|Participant Flow|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
10875702|NCT00439270|FG001|Participant Flow|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875703|NCT00439270|FG002|Participant Flow|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875704|NCT00439270|FG003|Participant Flow|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875705|NCT00439270|FG004|Participant Flow|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875706|NCT00439270|OG000|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875707|NCT00439270|OG000|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If 2 or more DLTs were observed for a dose level combination, the MTD was defined as the previous dose level combination.
10875708|NCT00439270|OG000|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If, for a dose level combination, 2 or more DLTs were observed, the maximum tolerated dose was defined as the previous dose level combination.
11348184|NCT04205669|EG000|Reported Event|Individual Treatment|Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
11348185|NCT04205669|EG001|Reported Event|Household Treatment|Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
11348186|NCT04198948|BG000|Baseline|Omeprazole, Then Placebo|"Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive placebo under same conditions in a cross-over manner.~Omeprazole: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.~Placebo oral tablet: Placebo will be administered orally once daily for 5 days in one of the two treatment periods.~Gliclazide: Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5."
10875709|NCT00439270|OG000|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 (Phase 2 )|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875710|NCT00439270|OG000|Outcome|All Treated|Participants received dasatinib, 50, 70, 100, or 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 or 75 mg/m^2.
10875711|NCT00439270|OG000|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875712|NCT00439270|OG001|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875713|NCT00439270|OG002|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875714|NCT00439270|OG003|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875715|NCT00439270|OG004|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875716|NCT00439270|OG002|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875717|NCT00439270|OG003|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
10875718|NCT00439270|EG000|Reported Event|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875719|NCT00439270|EG001|Reported Event|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875720|NCT00439270|EG002|Reported Event|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
10875721|NCT00439270|EG003|Reported Event|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875722|NCT00439270|EG004|Reported Event|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
10875723|NCT00439296|BG000|Baseline|Dose Level 1|Starting dose for study is 80 mg/m2/day of ABT-751
10875724|NCT00439296|BG001|Baseline|Dose Level 0|De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
10875725|NCT00439296|BG002|Baseline|Total|Total of all reporting groups
10875726|NCT00439296|FG000|Participant Flow|Dose Level 1|Starting dose for study is 80 mg/m2/day of ABT-751
10875727|NCT00439296|FG001|Participant Flow|Dose Level 0|De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
10875728|NCT00439296|OG000|Outcome|Dose Level 1|Starting dose for study is 80 mg/m2/day of ABT-751
10875729|NCT00439296|OG001|Outcome|Dose Level 0|De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
10875730|NCT00439296|EG000|Reported Event|Dose Level 1|Starting dose for study is 80 mg/m2/day of ABT-751
10875731|NCT00439296|EG001|Reported Event|Dose Level 0|De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
10875732|NCT00439309|BG000|Baseline|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
10875733|NCT00439309|BG001|Baseline|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
10875734|NCT00439309|BG002|Baseline|Total|Total of all reporting groups
10875735|NCT00439309|FG000|Participant Flow|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
11348187|NCT04198948|BG001|Baseline|Placebo, Then Omeprazole|"Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive omeprazole under same conditions in a cross-over manner.~Omeprazole: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.~Placebo oral tablet: Placebo will be administered orally once daily for 5 days in one of the two treatment periods.~Gliclazide: Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5."
11348188|NCT04198948|BG002|Baseline|Total|Total of all reporting groups
11348189|NCT04198948|FG000|Participant Flow|Omeprazole, Then Placebo|"Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive placebo under same conditions in a cross-over manner.~Omeprazole: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.~Placebo oral tablet: Placebo will be administered orally once daily for 5 days in one of the two treatment periods.~Gliclazide: Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5."
10987761|NCT00993187|OG000|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
10987762|NCT00993187|OG001|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
10987763|NCT00993187|EG000|Reported Event|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
10987764|NCT00993187|EG001|Reported Event|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
10987765|NCT00993200|BG000|Baseline|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
10987766|NCT00993200|BG001|Baseline|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
10987767|NCT00993200|BG002|Baseline|Total|Total of all reporting groups
10987768|NCT00993200|FG000|Participant Flow|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
10987769|NCT00993200|FG001|Participant Flow|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
10987770|NCT00993200|OG000|Outcome|Standard|Standard of care warfarin management
10987771|NCT00993200|OG001|Outcome|PERMIT|Warfarin management with use of gene-based warfarin dosing algorithm
10987772|NCT00993200|OG000|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
10987773|NCT00993200|OG001|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
11348190|NCT04198948|FG001|Participant Flow|Placebo, Then Omeprazole|"Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive omeprazole under same conditions in a cross-over manner.~Omeprazole: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.~Placebo oral tablet: Placebo will be administered orally once daily for 5 days in one of the two treatment periods.~Gliclazide: Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5."
10987774|NCT00993200|EG000|Reported Event|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
10987775|NCT00993200|EG001|Reported Event|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
10987776|NCT00993226|BG000|Baseline|SABER-Bupivacaine|5 mL, single dose instilled into surgical incision
10987777|NCT00993226|BG001|Baseline|SABER-placebo|5 mL, single dose instilled into surgical incision
10987778|NCT00993226|BG002|Baseline|Bupivacaine HCl|0.25% 40 mL, single dose infiltrated peri-incisionally
10987779|NCT00993226|BG003|Baseline|Total|Total of all reporting groups
10987780|NCT00993226|FG000|Participant Flow|SABER-Bupivacaine|5 mL, single dose instilled into surgical incision
10987781|NCT00993226|FG001|Participant Flow|SABER-placebo|5 mL, single dose instilled into surgical incision
10987782|NCT00993226|FG002|Participant Flow|Bupivacaine HCl|0.25% 40 mL, single dose infiltrated peri-incisionally
10987783|NCT00993226|OG000|Outcome|SABER-Bupivacaine|5 mL, single dose instilled into surgical incision
10987784|NCT00993226|OG001|Outcome|SABER-placebo|5 mL, single dose instilled into surgical incision
10987785|NCT00993226|OG002|Outcome|Bupivacaine HCl|0.25% 40 mL, single dose infiltrated peri-incisionally
10987786|NCT00993226|EG000|Reported Event|SABER-Bupivacaine|5 mL, single dose instilled into surgical incision
10987787|NCT00993226|EG001|Reported Event|SABER-placebo|5 mL, single dose instilled into surgical incision
10987788|NCT00993226|EG002|Reported Event|Bupivacaine HCl|0.25% 40 mL, single dose infiltrated peri-incisionally
11007297|NCT01090180|OG000|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
10987789|NCT00993265|BG000|Baseline|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
10987790|NCT00993265|BG001|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
10987791|NCT00993265|BG002|Baseline|Total|Total of all reporting groups
10987792|NCT00993265|FG000|Participant Flow|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
10987793|NCT00993265|FG001|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
10987794|NCT00993265|OG000|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
10987795|NCT00993265|OG001|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
10987796|NCT00993265|EG000|Reported Event|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
10987797|NCT00993265|EG001|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
10987798|NCT00993291|BG000|Baseline|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
10987799|NCT00993291|FG000|Participant Flow|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
10987800|NCT00993291|OG000|Outcome|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
10987801|NCT00993291|EG000|Reported Event|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
10987802|NCT00993317|BG000|Baseline|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
10987803|NCT00993317|BG001|Baseline|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
10987804|NCT00993317|BG002|Baseline|Total|Total of all reporting groups
10987805|NCT00993317|FG000|Participant Flow|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
10987806|NCT00993317|FG001|Participant Flow|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
10987807|NCT00993317|OG000|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
11348191|NCT04198948|OG000|Outcome|Gliclazide + Omeprazole|Participants received 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
11348192|NCT04198948|OG001|Outcome|Gliclazide + Placebo|Participants received placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
10987808|NCT00993317|OG001|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
10987809|NCT00993317|EG000|Reported Event|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
10987810|NCT00993317|EG001|Reported Event|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
10987811|NCT00993421|BG000|Baseline|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
10987812|NCT00993421|BG001|Baseline|LY377604 (75 mg)|Given orally, daily for 24 weeks.
10987813|NCT00993421|BG002|Baseline|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
10987814|NCT00993421|BG003|Baseline|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
10987815|NCT00993421|BG004|Baseline|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987816|NCT00993421|BG005|Baseline|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987817|NCT00993421|BG006|Baseline|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987818|NCT00993421|BG007|Baseline|Total|Total of all reporting groups
10987819|NCT00993421|FG000|Participant Flow|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
10987820|NCT00993421|FG001|Participant Flow|LY377604 (75 mg)|Given orally, daily for 24 weeks.
10987821|NCT00993421|FG002|Participant Flow|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
10987822|NCT00993421|FG003|Participant Flow|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
10987823|NCT00993421|FG004|Participant Flow|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987824|NCT00993421|FG005|Participant Flow|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987825|NCT00993421|FG006|Participant Flow|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987826|NCT00993421|OG000|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
10987827|NCT00993421|OG001|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
10987828|NCT00993421|OG002|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
10987829|NCT00993421|OG003|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
10987830|NCT00993421|OG004|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987831|NCT00993421|OG005|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987832|NCT00993421|OG006|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987833|NCT00993421|EG000|Reported Event|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
10987834|NCT00993421|EG001|Reported Event|LY377604 (75 mg)|Given orally, daily for 24 weeks.
10987835|NCT00993421|EG002|Reported Event|Sibutramine (30mg)/Metoprolol (200mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).~Placebo LY377604: given orally, daily for 24 weeks."
10987836|NCT00993421|EG003|Reported Event|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987837|NCT00993421|EG004|Reported Event|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987838|NCT00993421|EG005|Reported Event|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987839|NCT00993421|EG006|Reported Event|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
10987840|NCT00993473|BG000|Baseline|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
10987841|NCT00993473|BG001|Baseline|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
10987842|NCT00993473|BG002|Baseline|Total|Total of all reporting groups
10987843|NCT00993473|FG000|Participant Flow|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
10987844|NCT00993473|FG001|Participant Flow|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
10987845|NCT00993473|OG000|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
10987846|NCT00993473|OG001|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
10987847|NCT00993473|EG000|Reported Event|Lantus|
10987848|NCT00993473|EG001|Reported Event|NPH Insulin|
10987849|NCT00993499|BG000|Baseline|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
10987850|NCT00993499|BG001|Baseline|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
10987851|NCT00993499|BG002|Baseline|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
10987852|NCT00993499|BG003|Baseline|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
10987853|NCT00993499|BG004|Baseline|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
10987854|NCT00993499|BG005|Baseline|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
10987855|NCT00993499|BG006|Baseline|Total|Total of all reporting groups
10987856|NCT00993499|FG000|Participant Flow|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
10987857|NCT00993499|FG001|Participant Flow|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
10987858|NCT00993499|FG002|Participant Flow|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
10987859|NCT00993499|FG003|Participant Flow|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
10987860|NCT00993499|FG004|Participant Flow|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
10987861|NCT00993499|FG005|Participant Flow|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
10987862|NCT00993499|OG000|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
10987863|NCT00993499|OG001|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
10987864|NCT00993499|OG002|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
10987865|NCT00993499|OG003|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
10987866|NCT00993499|OG004|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
10987867|NCT00993499|OG005|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
10987868|NCT00993499|EG000|Reported Event|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
10987869|NCT00993499|EG001|Reported Event|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
10987870|NCT00993499|EG002|Reported Event|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
10987871|NCT00993499|EG003|Reported Event|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
10987872|NCT00993499|EG004|Reported Event|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
10987873|NCT00993499|EG005|Reported Event|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
10987874|NCT00993616|BG000|Baseline|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
10987875|NCT00993616|FG000|Participant Flow|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
10987876|NCT00993616|OG000|Outcome|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
10987877|NCT00993616|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10987878|NCT00993616|OG001|Outcome|Grade 1|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10987879|NCT00993616|OG002|Outcome|Grade 2|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10987880|NCT00993616|OG003|Outcome|Grade 3|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10987881|NCT00993616|OG004|Outcome|Grade 4|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10987882|NCT00993616|OG005|Outcome|Grade 5|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10987883|NCT00993616|EG000|Reported Event|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
10987884|NCT00993655|BG000|Baseline|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
10987885|NCT00993655|BG001|Baseline|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
10987886|NCT00993655|BG002|Baseline|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
10987887|NCT00993655|BG003|Baseline|Total|Total of all reporting groups
10987888|NCT00993655|FG000|Participant Flow|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
10987889|NCT00993655|FG001|Participant Flow|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
10987890|NCT00993655|FG002|Participant Flow|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
10987891|NCT00993655|OG000|Outcome|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
10987892|NCT00993655|OG001|Outcome|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
10987893|NCT00993655|OG002|Outcome|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
10987894|NCT00993655|OG000|Outcome|IV Carboplatin + IV Paclitaxel|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
10987895|NCT00993655|OG001|Outcome|IP Cisplatin + IV/IP Paclitaxel|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
11007298|NCT01090180|OG001|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
11007299|NCT01090180|EG000|Reported Event|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
10987896|NCT00993655|OG002|Outcome|IP Carboplatin + IV/IP Paclitaxel|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
10987897|NCT00993655|EG000|Reported Event|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
10987898|NCT00993655|EG001|Reported Event|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
10987899|NCT00993655|EG002|Reported Event|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
10987900|NCT00993668|BG000|Baseline|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
10987901|NCT00993668|BG001|Baseline|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
10987902|NCT00993668|BG002|Baseline|Total|Total of all reporting groups
10987903|NCT00993668|FG000|Participant Flow|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
10987904|NCT00993668|FG001|Participant Flow|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
10987905|NCT00993668|OG000|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
10987906|NCT00993668|OG001|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
10987907|NCT00993668|EG000|Reported Event|Placebo (Single Blind)|Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4
10987908|NCT00993668|EG001|Reported Event|Cimzia (Single Blind)|Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4
10987909|NCT00993668|EG002|Reported Event|Cimzia at Any Time|Certolizumab pegol (at any time) - Subjects randomized to receive Certolizumab pegol (CZP) during the single blind (SB) period will receive two subcutaneous (sc) injections of SB CZP 200 mg at Weeks 0, 2, and 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Subjects randomized to placebo during the SB period will receive two 0.9% saline sc injections at Week 0, Week 2, and Week 4, followed by two sc injections of OL CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
10987910|NCT00993798|BG000|Baseline|SABER-Bupivacaine|5 mL, single dose instilled subacromially
10987911|NCT00993798|BG001|Baseline|SABER-placebo|5 mL, single dose instilled subacromially
10987912|NCT00993798|BG002|Baseline|Bupivacaine HCl|0.25% 20 mL, single dose instilled subacromially
10987913|NCT00993798|BG003|Baseline|Total|Total of all reporting groups
10987914|NCT00993798|FG000|Participant Flow|SABER-Bupivacaine 5 mL|5 mL, single dose instilled subacromially
10987915|NCT00993798|FG001|Participant Flow|SABER-placebo 5 mL|5 mL, single dose instilled subacromially
10987916|NCT00993798|FG002|Participant Flow|Bupivacaine HCl 0.25% 20 mL|0.25% 20 mL, single dose instilled subacromially
10987917|NCT00993798|FG003|Participant Flow|SABER- Placebo 7.5 mL|7.5 mL, single dose instilled subacromially. This arm was never pursued.
10987918|NCT00993798|FG004|Participant Flow|SABER-Bupivacaine 7.5 mL|7.5 mL, single dose instilled subacromially. This arm was never pursued.
10987919|NCT00993798|OG000|Outcome|SABER-Bupivacaine|5 mL, single dose instilled subacromially
10987920|NCT00993798|OG001|Outcome|SABER-placebo|5 mL, single dose instilled subacromially
10987921|NCT00993798|OG002|Outcome|Bupivacaine HCl|0.25% 20 mL, single dose instilled subacromially
10987922|NCT00993798|EG000|Reported Event|SABER-Bupivacaine|5 mL, single dose instilled subacromially
10987923|NCT00993798|EG001|Reported Event|SABER-placebo|5 mL, single dose instilled subacromially
10987924|NCT00993798|EG002|Reported Event|Bupivacaine HCl|0.25% 20 mL, single dose instilled subacromially
11007300|NCT01090180|EG001|Reported Event|Arm 2: Placebo|Placebo (sugar pill): inactive
10987925|NCT00993824|BG000|Baseline|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
10987926|NCT00993824|BG001|Baseline|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
10987927|NCT00993824|BG002|Baseline|Total|Total of all reporting groups
10987928|NCT00993824|FG000|Participant Flow|Welchol Then Placebo|3.75 grams of colesevelam HCl (Welchol) taken for 12 weeks at evening meal, and then crossover to placebo taken at evening meal fro 12 weeks.
10987929|NCT00993824|FG001|Participant Flow|Placebo Then Welchol|Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
10987930|NCT00993824|OG000|Outcome|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
10987931|NCT00993824|OG001|Outcome|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
10987932|NCT00993824|OG000|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
10987933|NCT00993824|OG001|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
10987934|NCT00993824|EG000|Reported Event|Welchol|3.75 grams of colesevelam HCl taken at evening meal
10987935|NCT00993824|EG001|Reported Event|Placebo|Placebo taken at evening meal
10987936|NCT00993915|BG000|Baseline|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
10987937|NCT00993915|FG000|Participant Flow|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
10987938|NCT00993915|OG000|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
10987939|NCT00993915|EG000|Reported Event|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
10987940|NCT00993928|BG000|Baseline|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
10987941|NCT00993928|BG001|Baseline|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
10987942|NCT00993928|BG002|Baseline|Total|Total of all reporting groups
10987943|NCT00993928|FG000|Participant Flow|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
10987944|NCT00993928|FG001|Participant Flow|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
10987945|NCT00993928|OG000|Outcome|Arm A: Home-based Sleep Intervention With Device #1|"Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.>~> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet."
10987946|NCT00993928|OG001|Outcome|Arm B: Home-based Sleep Intervention With Device #2|"Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.>~> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet."
10987947|NCT00993928|OG000|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
10987948|NCT00993928|OG001|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
10987949|NCT00993928|OG000|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
10987950|NCT00993928|OG001|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
10987951|NCT00993928|EG000|Reported Event|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
10987952|NCT00993928|EG001|Reported Event|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
11007301|NCT01090310|BG000|Baseline|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
10987953|NCT00993954|BG000|Baseline|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
10987954|NCT00993954|BG001|Baseline|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
10987955|NCT00993954|BG002|Baseline|Total|Total of all reporting groups
10987956|NCT00993954|FG000|Participant Flow|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
10987957|NCT00993954|FG001|Participant Flow|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
10987958|NCT00993954|OG000|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
10987959|NCT00993954|OG001|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
10987960|NCT00993954|EG000|Reported Event|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
10987961|NCT00993954|EG001|Reported Event|Physician Reduction|"Patients randomized to reduction by physician~Physicians were free to use the reduction method of their choice"
10987962|NCT00993967|BG000|Baseline|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
10987963|NCT00993967|FG000|Participant Flow|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
10987964|NCT00993967|OG000|Outcome|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
10987965|NCT00993967|EG000|Reported Event|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
10987966|NCT00994110|BG000|Baseline|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
10987967|NCT00994110|BG001|Baseline|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
10987968|NCT00994110|BG002|Baseline|Total|Total of all reporting groups
10987969|NCT00994110|FG000|Participant Flow|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
11007302|NCT01090310|BG001|Baseline|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
11007303|NCT01090310|BG002|Baseline|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
11007304|NCT01090310|BG003|Baseline|Placebo|Placebo s.c. every 2 weeks
11007305|NCT01090310|BG004|Baseline|Total|Total of all reporting groups
10987970|NCT00994110|FG001|Participant Flow|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
10987971|NCT00994110|OG000|Outcome|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
10987972|NCT00994110|OG001|Outcome|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
10987973|NCT00994110|EG000|Reported Event|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
10987974|NCT00994110|EG001|Reported Event|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
10987975|NCT00994123|BG000|Baseline|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 + Erlotinib in patients with NSCLC
10987976|NCT00994123|BG001|Baseline|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
11223191|NCT02351700|EG000|Reported Event|Opioid-sparing Group|"Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4 mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2 mg every 2 hours and oral 2-4 mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.~IV Caldolor (Ibuprofen): Compare addition of IV Caldolor (ibuprofen) intraoperatively and postoperatively against IV placebo added intraoperatively and postoperatively."
11348193|NCT04198948|EG000|Reported Event|Gliclazide + Omeprazole|Participants received 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
10987977|NCT00994123|BG002|Baseline|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
10987978|NCT00994123|BG003|Baseline|Total|Total of all reporting groups
10987979|NCT00994123|FG000|Participant Flow|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 and erlotinib
10987980|NCT00994123|FG001|Participant Flow|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
10987981|NCT00994123|FG002|Participant Flow|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
10987982|NCT00994123|OG000|Outcome|Cohort 1|MM-121 6 mk/kg (Q2W IV) and 100 mg erlotinib (daily PO)
10987983|NCT00994123|OG001|Outcome|Cohort 2|6 mg/kg MM-121 Q2W + 150 mg erlotinib (daily PO)
10987984|NCT00994123|OG002|Outcome|Cohort 3|MM-121 12 mg/kg (Q2W IV) + 100 mg erlotinib (daily PO)
10987985|NCT00994123|OG003|Outcome|Cohort 4|MM-121 12 mg/kg (Q2W IV) + 150 mg erlotinib (PO daily)
10987986|NCT00994123|OG004|Outcome|Cohort 5|MM-121 20 mg/kg (weekly IV) + erlotinib 100 mg (PO daily)
10987987|NCT00994123|OG005|Outcome|Cohort 6|MM-121 20 mg/kg (Q2W IV) + erlotinib 100 mg (PO daily)
10987988|NCT00994123|OG006|Outcome|Cohort 7|MM-121 20 mg/kg (Q3W IV) + erlotinib 100 mg (PO daily)
10987989|NCT00994123|OG000|Outcome|Phase 1: All Participants|All participants in the dose escalation portion of the Phase 1
10987990|NCT00994123|OG000|Outcome|MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
10987991|NCT00994123|OG001|Outcome|Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
10987992|NCT00994123|OG000|Outcome|HRG High: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
10987993|NCT00994123|OG001|Outcome|HRG High: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
10987994|NCT00994123|OG002|Outcome|HRG Low: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
10987995|NCT00994123|OG003|Outcome|HRG Low: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
10987996|NCT00994123|EG000|Reported Event|Ph 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
10987997|NCT00994123|EG001|Reported Event|Ph 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
10987998|NCT00994123|EG002|Reported Event|Ph 1: MM-121 + Erlotinib|Escalating Doses of MM-121 + erlotinib
10987999|NCT00994175|BG000|Baseline|All Participants|All subjects who started the study.
10988000|NCT00994175|FG000|Participant Flow|Pioglitazone, Then Placebo|Pioglitazone, 30 mg daily, was administered for the initial 2 weeks of the first treatment phase, followed by 45 mg daily for an additional 14 weeks. This was followed by a 4-week washout period. Subjects were assessed for clinical stability during a second 4-week run-in period prior to crossing over to the placebo phase for 16 weeks in the second treatment phase to receive the placebo.
10988001|NCT00994175|FG001|Participant Flow|Placebo, Then Pioglitazone|Placebo was administered for 16 weeks. This was followed by a 4-week washout period. Subjects were assessed for clinical stability during a second 4-week run-in period prior to crossing over to the Pioglitazone treatment group. Pioglitazone, 30 mg daily, was administered for the initial 2 weeks of the treatment phase, followed by 45 mg daily for an additional 14 weeks.
10988002|NCT00994175|OG000|Outcome|Pioglitazone|Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
10988003|NCT00994175|OG001|Outcome|Placebo|Subjects received a matched placebo.
10988004|NCT00994175|EG000|Reported Event|Pioglitazone|Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
10988005|NCT00994175|EG001|Reported Event|Placebo|Subjects received a matched placebo.
11007306|NCT01090310|FG000|Participant Flow|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
11007307|NCT01090310|FG001|Participant Flow|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
11007308|NCT01090310|FG002|Participant Flow|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
11007309|NCT01090310|FG003|Participant Flow|Placebo|Placebo s.c. every 2 weeks
11007310|NCT01090310|OG000|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
11007311|NCT01090310|OG001|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
11007312|NCT01090310|OG002|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
11007313|NCT01090310|OG003|Outcome|Placebo|Placebo s.c. every 2 weeks
11007314|NCT01090310|EG000|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks
11007315|NCT01090310|EG001|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300mg every 4 weeks
11007316|NCT01090310|EG002|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150mg every 4 weeks
11007317|NCT01090310|EG003|Reported Event|Placebo Every 2 Weeks|Placebo every 2 weeks
11007318|NCT01090323|BG000|Baseline|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
11007319|NCT01090323|BG001|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
11007320|NCT01090323|BG002|Baseline|Total|Total of all reporting groups
11007321|NCT01090323|FG000|Participant Flow|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
11007322|NCT01090323|FG001|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
11007323|NCT01090323|OG000|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
11007324|NCT01090323|OG001|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
11348194|NCT04198948|EG001|Reported Event|Gliclazide + Placebo|Participants received placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
10988006|NCT00994214|BG000|Baseline|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
10988007|NCT00994214|BG001|Baseline|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
10988008|NCT00994214|BG002|Baseline|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
10988009|NCT00994214|BG003|Baseline|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections..
10988010|NCT00994214|BG004|Baseline|Total|Total of all reporting groups
10988011|NCT00994214|FG000|Participant Flow|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
10988012|NCT00994214|FG001|Participant Flow|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
10988013|NCT00994214|FG002|Participant Flow|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
10988014|NCT00994214|FG003|Participant Flow|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
10988015|NCT00994214|OG000|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
10988016|NCT00994214|OG001|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
10988017|NCT00994214|OG002|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
10988018|NCT00994214|OG003|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
10988019|NCT00994214|OG002|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
10988020|NCT00994214|OG003|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections
10988021|NCT00994214|OG000|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections
10988022|NCT00994214|OG001|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections
10988023|NCT00994214|OG000|Outcome|Part A: Arm A: BIM 23A760 1 mg|
10988024|NCT00994214|OG001|Outcome|Part A: Arm B: BIM 23A760 2 mg|
10988025|NCT00994214|OG002|Outcome|Part A: Arm C: BIM 23A760 4 mg|
10988026|NCT00994214|OG003|Outcome|Part A: Arm D: BIM 23A760 6 mg|
10988027|NCT00994214|OG004|Outcome|Overall - Part A|
10988028|NCT00994214|OG005|Outcome|Part B: Arm B: BIM 23A760 2 mg|
10988029|NCT00994214|OG006|Outcome|Part B: Arm C: BIM 23A760 4 mg|
10988030|NCT00994214|OG007|Outcome|Part B: Arm D: BIM 23A760 6 mg|
10988031|NCT00994214|OG008|Outcome|Overall - Part B|
10988032|NCT00994214|EG000|Reported Event|Part A: Arm A: BIM 23A760 1 mg|
10988033|NCT00994214|EG001|Reported Event|Part A: Arm B: BIM 23A760 2 mg|
10988034|NCT00994214|EG002|Reported Event|Part A: Arm C: BIM 23A760 4 mg|
10988035|NCT00994214|EG003|Reported Event|Part A: Arm D: BIM 23A760 6 mg|
10988036|NCT00994214|EG004|Reported Event|Overall - Part A|
10988037|NCT00994214|EG005|Reported Event|Part B: Arm B: BIM 23A760 2 mg|
10988038|NCT00994214|EG006|Reported Event|Part B: Arm C: BIM 23A760 4 mg|
10988039|NCT00994214|EG007|Reported Event|Part B: Arm D: BIM 23A760 6 mg|
10988040|NCT00994214|EG008|Reported Event|Overall - Part B|
10988041|NCT00994240|BG000|Baseline|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
10988042|NCT00994240|BG001|Baseline|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
10988043|NCT00994240|BG002|Baseline|Total|Total of all reporting groups
10988044|NCT00994240|FG000|Participant Flow|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
10988045|NCT00994240|FG001|Participant Flow|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
10988046|NCT00994240|OG000|Outcome|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
10988047|NCT00994240|OG001|Outcome|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
10988048|NCT00994240|EG000|Reported Event|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
10988049|NCT00994240|EG001|Reported Event|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
10988050|NCT00994279|BG000|Baseline|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
10988051|NCT00994279|BG001|Baseline|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
10988052|NCT00994279|BG002|Baseline|Total|Total of all reporting groups
10988053|NCT00994279|FG000|Participant Flow|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
10988054|NCT00994279|FG001|Participant Flow|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
10988055|NCT00994279|OG000|Outcome|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
10988056|NCT00994279|OG001|Outcome|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
10988057|NCT00994279|EG000|Reported Event|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
10988058|NCT00994279|EG001|Reported Event|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
10988059|NCT00994318|BG000|Baseline|FCM (High Ferritin Target|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
10988060|NCT00994318|BG001|Baseline|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
10988061|NCT00994318|BG002|Baseline|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
10988062|NCT00994318|BG003|Baseline|Total|Total of all reporting groups
10988063|NCT00994318|FG000|Participant Flow|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
10988064|NCT00994318|FG001|Participant Flow|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
10988065|NCT00994318|FG002|Participant Flow|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
10988066|NCT00994318|OG000|Outcome|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 400-600 mcg/L
10988067|NCT00994318|OG001|Outcome|FCM (Low Ferritin Level)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 100-200 mcg/L
10988068|NCT00994318|OG002|Outcome|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
10988069|NCT00994318|EG000|Reported Event|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
10988070|NCT00994318|EG001|Reported Event|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
10988071|NCT00994318|EG002|Reported Event|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
10988072|NCT00994422|BG000|Baseline|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
10988073|NCT00994422|BG001|Baseline|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
10988074|NCT00994422|BG002|Baseline|Total|Total of all reporting groups
10988075|NCT00994422|FG000|Participant Flow|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
10988076|NCT00994422|FG001|Participant Flow|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
10988077|NCT00994422|OG000|Outcome|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
10988078|NCT00994422|OG001|Outcome|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
10988079|NCT00994422|OG000|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
10988080|NCT00994422|OG001|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
10988081|NCT00994422|EG000|Reported Event|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
10988082|NCT00994422|EG001|Reported Event|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
10988083|NCT00994448|BG000|Baseline|Bupropion|Bupropion SR 150 mg twice a day
10988084|NCT00994448|BG001|Baseline|Placebo (Sugar Pill)|Matching placebo tablets twice a day
10988085|NCT00994448|BG002|Baseline|Total|Total of all reporting groups
10988086|NCT00994448|FG000|Participant Flow|Bupropion|Bupropion SR 150 mg twice a day
10988087|NCT00994448|FG001|Participant Flow|Placebo (Sugar Pill)|Matching placebo tablets twice a day
10988088|NCT00994448|OG000|Outcome|Bupropion|Bupropion SR 150 mg twice a day
10988089|NCT00994448|OG001|Outcome|Placebo (Sugar Pill)|Matching placebo tablets twice a day
10988090|NCT00994448|EG000|Reported Event|Bupropion|Bupropion SR 150 mg twice a day
10988091|NCT00994448|EG001|Reported Event|Placebo (Sugar Pill)|Matching placebo tablets twice a day
10988092|NCT00994461|BG000|Baseline|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
10988093|NCT00994461|BG001|Baseline|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
10988094|NCT00994461|BG002|Baseline|Placebo|Placebo tablet three times a day with meal for 2 weeks
10988095|NCT00994461|BG003|Baseline|Total|Total of all reporting groups
10988096|NCT00994461|FG000|Participant Flow|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
10988097|NCT00994461|FG001|Participant Flow|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
10988098|NCT00994461|FG002|Participant Flow|Placebo|Placebo tablet three times a day with meal for 2 weeks
10988099|NCT00994461|OG000|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
10988100|NCT00994461|OG001|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
10988101|NCT00994461|OG002|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
10988102|NCT00994461|EG000|Reported Event|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
10988103|NCT00994461|EG001|Reported Event|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
10988104|NCT00994461|EG002|Reported Event|Placebo|Placebo tablet three times a day with meal for 2 weeks
10988105|NCT00994604|BG000|Baseline|Broccoli Sprout Extract|broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks
10988106|NCT00994604|FG000|Participant Flow|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
10988107|NCT00994604|OG000|Outcome|Broccoli Sprout Extract - BP|pre- and post-consumption of broccoli sprout extract for 2 weeks
10988108|NCT00994604|OG001|Outcome|Broccoli Sprout Extract - BD|pre- and post-consumption of broccoli sprout extract for 2 weeks
10988109|NCT00994604|OG000|Outcome|Airway Size Pre BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
10988110|NCT00994604|OG001|Outcome|Airway Size Post BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
10988111|NCT00994604|EG000|Reported Event|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
10988112|NCT00994643|BG000|Baseline|Treatment (Interleukin Therapy, Monoclonal Antibody)|"Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.~Rituximab: Given IV~Interleukin-2: Given SC"
10988113|NCT00994643|FG000|Participant Flow|Treatment (Interleukin Therapy, Monoclonal Antibody)|"Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.~Rituximab: Given IV~Interleukin-2: Given SC"
10988114|NCT00994643|OG000|Outcome|Treatment (Interleukin Therapy, Monoclonal Antibody)|"Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.~Rituximab: Given IV~Interleukin-2: Given SC"
10988115|NCT00994643|EG000|Reported Event|Treatment (Interleukin Therapy, Monoclonal Antibody)|"Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.~Rituximab: Given IV~Interleukin-2: Given SC"
10988116|NCT00994682|BG000|Baseline|Placebo|Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
10988117|NCT00994682|BG001|Baseline|Pioglitazone|Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
10988118|NCT00994682|BG002|Baseline|Total|Total of all reporting groups
10988119|NCT00994682|FG000|Participant Flow|Placebo|After all participants receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on placebo (or pioglitazone) in a randomized, double-blind,placebo-controlled study design by the research pharmacy. Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills.
10988120|NCT00994682|FG001|Participant Flow|Pioglitazone|After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or T2DM and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d).
10988121|NCT00994682|OG000|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
10988122|NCT00994682|OG001|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
10988123|NCT00994682|OG000|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
10988124|NCT00994682|OG001|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
10988125|NCT00994682|EG000|Reported Event|Placebo (First 18 Months)|Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills.
10988126|NCT00994682|EG001|Reported Event|Pioglitazone (First 18 Months)|Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d).
10988127|NCT00994682|EG002|Reported Event|Placebo (PIO Open-label)|After being randomized to placebo for the first 18 months, patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
10988128|NCT00994682|EG003|Reported Event|Pioglitazone (Months 18-36)|After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
10988129|NCT00994760|BG000|Baseline|GENISIS|Intranasal Fentanyl Spray
10988130|NCT00994760|FG000|Participant Flow|GENISIS|Intranasal Fentanyl Spray
10988131|NCT00994760|OG000|Outcome|Study Start|
10988132|NCT00994760|OG001|Outcome|Study End|
10988133|NCT00994760|OG000|Outcome|Initial Visit|
10988134|NCT00994760|OG001|Outcome|Last Visit|
10988135|NCT00994760|OG000|Outcome|Last Visit|
10988136|NCT00994760|OG000|Outcome|First Visit (FV): Patients With Previous BTP- Medication Only|
10988137|NCT00994760|OG001|Outcome|Last Visit (LV)|
10988138|NCT00994760|OG000|Outcome|Physician Last Visit (LV)|
10988139|NCT00994760|OG000|Outcome|GENISIS|Intranasal Fentanyl Spray
10988140|NCT00994760|OG000|Outcome|Initial Visit (IV)|
10988141|NCT00994760|OG000|Outcome|First Visit|
10988142|NCT00994760|OG000|Outcome|Patients at First Visit|
10988143|NCT00994760|OG000|Outcome|Patients at Final Visit|
10988144|NCT00994760|OG000|Outcome|First Visit (FV)(Patients With Previous BTP-medication Only)|
10988145|NCT00994760|OG000|Outcome|Caregiver at Final Visit|
10988146|NCT00994760|EG000|Reported Event|All Patients Treated|
10988147|NCT00994890|BG000|Baseline|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection subcutaneously every 8 weeks up to 24 weeks.
10988148|NCT00994890|BG001|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection subcutaneously every 8 weeks up to 24 weeks.
10988149|NCT00994890|BG002|Baseline|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection subcutaneously every 8 weeks up to 24 weeks.
10988150|NCT00994890|BG003|Baseline|Total|Total of all reporting groups
10988151|NCT00994890|FG000|Participant Flow|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection subcutaneously every 8 weeks up to 24 weeks.
10988152|NCT00994890|FG001|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection subcutaneously every 8 weeks up to 24 weeks.
10988153|NCT00994890|FG002|Participant Flow|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection subcutaneously every 8 weeks up to 24 weeks.
10988154|NCT00994890|OG000|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection subcutaneously every 8 weeks up to 24 weeks.
10988155|NCT00994890|OG001|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection subcutaneously every 8 weeks up to 24 weeks.
10988156|NCT00994890|OG002|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection subcutaneously every 8 weeks up to 24 weeks.
10988157|NCT00994890|EG000|Reported Event|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection subcutaneously every 8 weeks up to 24 weeks.
10988158|NCT00994890|EG001|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection subcutaneously every 8 weeks up to 24 weeks.
10988159|NCT00994890|EG002|Reported Event|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection subcutaneously every 8 weeks up to 24 weeks.
10988160|NCT00994929|BG000|Baseline|Neumega (Oprelveken, Interleukin 11)|The VWD subjects included two with type 1 VWD and two with type 2 VWD, including one with type 2B, with increased platelet aggregation at low strength ristocetin and absent high molecular weight multimers, and one with type 2M disease, with reduced VWF:RCoF/ VWF:Ag ratio <0.50, per NHLBI criteria (Table 2).5 All subjects had positive past bleeding histories. Pregnancy, lactation, heart disease, uncontrolled hypertension, arrhythmia, thrombosis, recent surgery or receipt of blood products were exclusions. A total of nine subjects were enrolled and completed study, including five with hemophilia A and four with VWD. The median age was 26 years, range 22-51 years
10988161|NCT00994929|FG000|Participant Flow|Neumega (Oprelveken, Interleukin 11)|25 µg/kilogram of body weight of rhIL-11 subcutaneously administered on days 1 to 4. On day 4 following rhIL-11 injection DDAVP was subsequently given at 0.3 mcg/kg intravenously over 30 minutes. For any subject with past allergic reactions, hypersensitivity, or seizures with DDAVP, or in whom DDAVP is contraindicated, DDAVP was not given: only rhIL-11 was given on Day 4.
10988162|NCT00994929|OG000|Outcome|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11.
10988163|NCT00994929|OG000|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
10988164|NCT00994929|EG000|Reported Event|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed on day 4 by DDAVP 0.3 microgram/kg by intravenous infusion.
10988165|NCT00995007|BG000|Baseline|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
10988166|NCT00995007|BG001|Baseline|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
10988167|NCT00995007|BG002|Baseline|Total|Total of all reporting groups
10988168|NCT00995007|FG000|Participant Flow|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
10988169|NCT00995007|FG001|Participant Flow|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
10988170|NCT00995007|OG000|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
10988171|NCT00995007|OG001|Outcome|Glioblastoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
10988172|NCT00995007|OG002|Outcome|Anaplastic Astrocytomas (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
10988173|NCT00995007|OG003|Outcome|Anaplastic Astrocytomas (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
10988174|NCT00995007|OG001|Outcome|Glioblastoma (Carboplation Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
10988175|NCT00995007|OG002|Outcome|Anaplastic Astrocytoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
10988176|NCT00995007|OG003|Outcome|Anaplastic Astrocytoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
10988177|NCT00995007|OG000|Outcome|Carboplatin|"Combo Group (both drugs together)~ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
10988178|NCT00995007|OG001|Outcome|Vandetanib With Carboplatin|"Sequential Group (carboplatin followed by vandetanib)~ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
10988179|NCT00995007|OG002|Outcome|Cross Over to Vandetanib|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
11336376|NCT03565666|FG002|Participant Flow|iLet/Fiasp Then Either iLet With Novolog/Humalog or Usual Care|Participants first started the insulin-only iLet using Fiasp for 7 days, then switched to either the insulin-only iLet arm using Novolog or Humalog for 7 days or the usual care arm, (managing their diabetes with either multiple daily injections or insulin pump) for 7 days. No washout period was required between arms
10988180|NCT00995007|EG000|Reported Event|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
10988181|NCT00995007|EG001|Reported Event|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
10988182|NCT00995007|EG002|Reported Event|Crossover to Vandetanib|ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
10988183|NCT00995020|BG000|Baseline|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
10988184|NCT00995020|BG001|Baseline|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
10988185|NCT00995020|BG002|Baseline|Total|Total of all reporting groups
10988186|NCT00995020|FG000|Participant Flow|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ (straight wire excision of the transformation zone), which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
10988187|NCT00995020|FG001|Participant Flow|LLETZ Cone: Large Loop Excision of Transformation Zone - Cone|The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium.
10988188|NCT00995020|OG000|Outcome|SWETZ|SWETZ (Straight wire excision of the transformation zone), the experimental intervention, is a cone biopsy procedure that uses a 1cm X 0.20mm straight wire to fashion a cone excision,with the ambition of removing 20-25 mm length of endocervical epithelium. Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
10988189|NCT00995020|OG001|Outcome|LLETZ Cone|LLETZ cone,the standard procedure is performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
10988190|NCT00995020|OG000|Outcome|LLETZ - Cone|LLETZ - cone was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
10988191|NCT00995020|OG001|Outcome|SWETZ|SWETZ uses a 1cm straight 0.20mm wire to fashion a similar excision.
10988192|NCT00995020|EG000|Reported Event|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
10988193|NCT00995020|EG001|Reported Event|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
10988194|NCT00995072|BG000|Baseline|Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg|"Nebivolol 5 mg daily for 12 weeks followed by Metoprolol succinate 100 mg daily for 12 weeks. A two week washout (no medication) is completed prior to switching to metoprolol.~nebivolol and metoprolol succinate: Subjects randomized to treatment Arm A will receive nebivolol 5 mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm A will then receive metoprolol succinate 100 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks."
10988195|NCT00995072|BG001|Baseline|Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily|"Metoprolol succinate 100 mg daily for 12 weeks followed by nebivolol 5 mg daily for 12 weeks. A two week washout (no medication) is completed prior to switching to nebivolol.~metoprolol succinate and nebivolol: Subjects randomized to treatment Arm B will receive metoprolol succinate 100mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm B will then receive nebivolol 5 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks."
10988196|NCT00995072|BG002|Baseline|Total|Total of all reporting groups
11007325|NCT01090323|EG000|Reported Event|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
10988197|NCT00995072|FG000|Participant Flow|Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg|"Nebivolol 5 mg daily for 12 weeks followed by Metoprolol succinate 100 mg daily for 12 weeks. A two week washout (no medication) is completed prior to switching to metoprolol.~nebivolol and metoprolol succinate: Subjects randomized to treatment Arm A will receive nebivolol 5 mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm A will then receive metoprolol succinate 100 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks."
10988198|NCT00995072|FG001|Participant Flow|Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily|"Metoprolol succinate 100 mg daily for 12 weeks followed by nebivolol 5 mg daily for 12 weeks. A two week washout (no medication) is completed prior to switching to nebivolol.~metoprolol succinate and nebivolol: Subjects randomized to treatment Arm B will receive metoprolol succinate 100mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm B will then receive nebivolol 5 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks."
10988199|NCT00995072|OG000|Outcome|Nebivolol 5 mg Daily|Nebivolol 5 mg daily for 12 weeks
10988200|NCT00995072|OG001|Outcome|Metoprolol Succinate 100 mg Daily|Metoprolol succinate 100 mg daily for 12 weeks
10988201|NCT00995072|EG000|Reported Event|Nebivolol 5 mg|Nebivolol 5 mg daily
10988202|NCT00995072|EG001|Reported Event|Metoprolol Succinate 100 mg|Metoprolol succinate 100 mg daily
10988203|NCT00995085|BG000|Baseline|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
10988204|NCT00995085|FG000|Participant Flow|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
10988205|NCT00995085|OG000|Outcome|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
10988206|NCT00995085|EG000|Reported Event|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
10988207|NCT00995215|BG000|Baseline|Evaluation of Temporary, Intra-operative Wire Lead Placement i|These studies were performed in subjects (n=6) undergoing surgery for permanent placement of disc electrodes to restore cough in our previous clinical trial
10988208|NCT00995215|FG000|Participant Flow|Spinal Cord Stimulation|"The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit~Spinal Cord Stimulation: The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit.~Expiratory Muscle Stimulator: T"
10988209|NCT00995215|OG000|Outcome|Spinal Cord Stimulation (SCS) With Disc Electrodes|Effects of electrical spinal cord stimulation with disc on airway pressure generation was evaluated.
10988210|NCT00995215|OG001|Outcome|Spinal Cord Stimulation (SCS) With Parallel Wire Leads|Effects of electrical spinal cord stimulation (SCS) with parallel wire leads on airway pressure generation was evaluated.
10988211|NCT00995215|EG000|Reported Event|Spinal Cord Stimulation|"Experimental: Spinal Cord Stimulation~The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit."
10988212|NCT00995345|BG000|Baseline|Placebo|Tablet
10988213|NCT00995345|BG001|Baseline|Dose 1: KRP-104|40 mg QD
10988214|NCT00995345|BG002|Baseline|Dose 2: KRP-104|80 mg QD
10988215|NCT00995345|BG003|Baseline|Dose 3: KRP-104|100 mg QD
10988216|NCT00995345|BG004|Baseline|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
10988217|NCT00995345|BG005|Baseline|Total|Total of all reporting groups
10988218|NCT00995345|FG000|Participant Flow|Placebo|Tablet
10988219|NCT00995345|FG001|Participant Flow|Dose 1: KRP-104|40 mg QD
10988220|NCT00995345|FG002|Participant Flow|Dose 2: KRP-104|80 mg QD
10988221|NCT00995345|FG003|Participant Flow|Dose 3: KRP-104|100 mg QD
10988222|NCT00995345|FG004|Participant Flow|Dose 4: KRP-104|20 mg /120 mg QD (dose switch at week12)
10988223|NCT00995345|OG000|Outcome|Placebo|Tablet
10988224|NCT00995345|OG001|Outcome|Dose 1: KRP-104|40 mg QD
10988225|NCT00995345|OG002|Outcome|Dose 2: KRP-104|80 mg QD
10988226|NCT00995345|OG003|Outcome|Dose 3: KRP-104|100 mg QD
10988227|NCT00995345|OG004|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
10988228|NCT00995345|EG000|Reported Event|Placebo|Tablet
10988229|NCT00995345|EG001|Reported Event|Dose 1: KRP-104|40 mg QD
10988230|NCT00995345|EG002|Reported Event|Dose 2: KRP-104|80 mg QD
10988231|NCT00995345|EG003|Reported Event|Dose 3: KRP-104|100 mg QD
10988232|NCT00995345|EG004|Reported Event|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
10988233|NCT00995371|BG000|Baseline|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
10988234|NCT00995371|BG001|Baseline|Epidural Steroid Injection|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
10988235|NCT00995371|BG002|Baseline|Total|Total of all reporting groups
10988236|NCT00995371|FG000|Participant Flow|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
11336377|NCT03565666|OG000|Outcome|Usual Care Arm|Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
10988237|NCT00995371|FG001|Participant Flow|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit
10988238|NCT00995371|OG000|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
10988239|NCT00995371|OG001|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
10988240|NCT00995371|OG001|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
10988241|NCT00995371|EG000|Reported Event|Vertos Mild® Minimally-Invasive Lumbar Decompression|Group 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
10988242|NCT00995371|EG001|Reported Event|Epidural Steroid Injection|"Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.~The ESI group analyzed crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure"
10988243|NCT00995371|EG002|Reported Event|ESI Cross-over to Lumbar Decompression With Mild|Group 3: Patients in the Epidural Steroid Injection (ESI) group treated by the physicians in accordance with product labeling and indications for use, crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure
10988244|NCT00995410|BG000|Baseline|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
10988245|NCT00995410|FG000|Participant Flow|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
10988246|NCT00995410|OG000|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
10988247|NCT00995410|EG000|Reported Event|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
10988248|NCT00995436|BG000|Baseline|Headgear|"Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage : Extra oral anchorage using headgear"
10988249|NCT00995436|BG001|Baseline|Miniscrews|"Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
10988250|NCT00995436|BG002|Baseline|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
10988251|NCT00995436|BG003|Baseline|Total|Total of all reporting groups
10988252|NCT00995436|FG000|Participant Flow|Headgear|"Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage : Extra oral anchorage using headgear"
10988253|NCT00995436|FG001|Participant Flow|Miniscrews|"Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
10988254|NCT00995436|FG002|Participant Flow|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
10988255|NCT00995436|OG000|Outcome|Miniscrews|"Device Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
10988256|NCT00995436|OG001|Outcome|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
10988257|NCT00995436|OG002|Outcome|Headgear|
10988258|NCT00995436|EG000|Reported Event|Headgear|"Device Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage: Extra oral anchorage"
10988259|NCT00995436|EG001|Reported Event|Miniscrews|"Device Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
10988260|NCT00995436|EG002|Reported Event|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
10988261|NCT00995449|BG000|Baseline|KB003 70mg|Dose group not evaluated in this portion of study
10988262|NCT00995449|BG001|Baseline|KB003 200 mg|Dose group not evaluated in this portion of study
10988263|NCT00995449|BG002|Baseline|KB003 600 mg|600 mg, KB003 a monoclonal antibody
10988264|NCT00995449|BG003|Baseline|Placebo|Placebo comparator
10988265|NCT00995449|BG004|Baseline|Total|Total of all reporting groups
10988266|NCT00995449|FG000|Participant Flow|KB003 70mg|Dose group not evaluated in this portion of study
10988267|NCT00995449|FG001|Participant Flow|KB003 200 mg|Dose group not evaluated in this portion of study
10988268|NCT00995449|FG002|Participant Flow|KB003 600 mg|600 mg, KB003 a monoclonal antibody
10988269|NCT00995449|FG003|Participant Flow|Placebo|Placebo comparator
10988270|NCT00995449|OG000|Outcome|KB003 600 mg|600 mg, KB003 a monoclonal antibody
10988271|NCT00995449|OG001|Outcome|Placebo|Placebo comparator
10988272|NCT00995449|EG000|Reported Event|KB003 70mg|Dose group not evaluated in this portion of study
10988273|NCT00995449|EG001|Reported Event|KB003 200 mg|Dose group not evaluated in this portion of study
10988274|NCT00995449|EG002|Reported Event|KB003 600 mg|600 mg, KB003 a monoclonal antibody
10988275|NCT00995449|EG003|Reported Event|Placebo|Placebo comparator
10988276|NCT00995475|BG000|Baseline|Inhaled Corticosteroid, Then Placebo or Vice Versa|"FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks.~Then 2 weeks of wash-out.~Then followed by FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks."
10988277|NCT00995475|FG000|Participant Flow|Inhaled Corticosteroid One Month|"FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Then two-week washout before placebo.~Fluticasone propionate"
10988278|NCT00995475|FG001|Participant Flow|Placebo Control One Month|"FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. Then two-week washout before FP.~Placebo"
10988279|NCT00995475|OG000|Outcome|Inhaled Corticosteroid|"FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks.~Fluticasone propionate"
10988280|NCT00995475|OG001|Outcome|Placebo Control|"FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks.~Placebo"
10988281|NCT00995475|EG000|Reported Event|Inhaled Corticosteroid|"FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks.~Fluticasone propionate"
10988282|NCT00995475|EG001|Reported Event|Placebo Control|"FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks.~Placebo"
10988283|NCT00995488|BG000|Baseline|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
10988284|NCT00995488|FG000|Participant Flow|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
10988285|NCT00995488|OG000|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
10988286|NCT00995488|EG000|Reported Event|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
10988287|NCT00995501|BG000|Baseline|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
10988288|NCT00995501|BG001|Baseline|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988289|NCT00995501|BG002|Baseline|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
10988290|NCT00995501|BG003|Baseline|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
10988291|NCT00995501|BG004|Baseline|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988292|NCT00995501|BG005|Baseline|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
11007326|NCT01090323|EG001|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
11336378|NCT03565666|OG001|Outcome|iLet With Insulin Analogue (Novolog/Humalog) Arm|Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
11336379|NCT03565666|OG002|Outcome|iLet Using Fiasp Arm|Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
10988293|NCT00995501|BG006|Baseline|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
10988294|NCT00995501|BG007|Baseline|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988295|NCT00995501|BG008|Baseline|Total|Total of all reporting groups
10988296|NCT00995501|FG000|Participant Flow|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
10988297|NCT00995501|FG001|Participant Flow|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988298|NCT00995501|FG002|Participant Flow|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
10988299|NCT00995501|FG003|Participant Flow|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
10988300|NCT00995501|FG004|Participant Flow|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988301|NCT00995501|FG005|Participant Flow|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988302|NCT00995501|FG006|Participant Flow|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
10988303|NCT00995501|FG007|Participant Flow|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
11336380|NCT03565666|OG001|Outcome|iLet Using Humalog/Novolog Arm|Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
11336381|NCT03565666|OG000|Outcome|RCT Period Days 1-7|36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Half of the subjects (n=18) will wear the Dexcom G5 continuous glucose monitor (CGM) and the other half will wear a Senseonics Eversense CGM.
10988304|NCT00995501|OG000|Outcome|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
10988305|NCT00995501|OG001|Outcome|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988306|NCT00995501|OG002|Outcome|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
10988307|NCT00995501|OG003|Outcome|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
10988308|NCT00995501|OG004|Outcome|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988309|NCT00995501|OG005|Outcome|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988310|NCT00995501|OG006|Outcome|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
10988311|NCT00995501|OG007|Outcome|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988312|NCT00995501|EG000|Reported Event|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
10988313|NCT00995501|EG001|Reported Event|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
11007327|NCT01090414|BG000|Baseline|101-02|Participants with CLL, iNHL, MCL, DLBCL, AML, or MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
10988314|NCT00995501|EG002|Reported Event|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
10988315|NCT00995501|EG003|Reported Event|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
10988316|NCT00995501|EG004|Reported Event|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988317|NCT00995501|EG005|Reported Event|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988318|NCT00995501|EG006|Reported Event|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
10988319|NCT00995501|EG007|Reported Event|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
10988320|NCT00995553|BG000|Baseline|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
10988321|NCT00995553|BG001|Baseline|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
10988322|NCT00995553|BG002|Baseline|Total|Total of all reporting groups
10988323|NCT00995553|FG000|Participant Flow|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
10988324|NCT00995553|FG001|Participant Flow|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
10988325|NCT00995553|OG000|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
10988326|NCT00995553|OG001|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
10988327|NCT00995553|EG000|Reported Event|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
10988328|NCT00995553|EG001|Reported Event|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
10988329|NCT00995566|BG000|Baseline|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
10988330|NCT00995566|FG000|Participant Flow|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
10988331|NCT00995566|OG000|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
10988332|NCT00995566|EG000|Reported Event|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
10988333|NCT00995670|BG000|Baseline|Sevoflurane and Glucose|"Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min to prevent the anesthetic preconditioning (sevoflurane) protection against subsequent I/R injury.~Sevoflurane: 1 minimum alveolar concentration (MAC) for 20 min (after hour of glucose and before I/R) 26 volunteers were studied 67 times in this arm."
10988334|NCT00995670|BG001|Baseline|Vitamin C and Glucose|"To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.~Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.~Vitamin C: 1 gm iv bolus injection 5 min before I/R injury 16 volunteers were studied 25 times in this arm."
10988335|NCT00995670|BG002|Baseline|Statin and Glucose|"Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.~Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.~Statin: 40 mg of simvastatin 17 volunteers were studied 31 times in this arm."
10988336|NCT00995670|BG003|Baseline|Total|Total of all reporting groups
10988337|NCT00995670|FG000|Participant Flow|Sevoflurane and Glucose|Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
10988338|NCT00995670|FG001|Participant Flow|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
10988339|NCT00995670|FG002|Participant Flow|Statin and Glucose|Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.
10988340|NCT00995670|OG000|Outcome|Sevoflurane and Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
10988341|NCT00995670|OG001|Outcome|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
10988342|NCT00995670|OG002|Outcome|Statin and Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
10988343|NCT00995670|EG000|Reported Event|Sevoflurane & Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
10988344|NCT00995670|EG001|Reported Event|Vitamin C & Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
10988345|NCT00995670|EG002|Reported Event|Statins & Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
10988346|NCT00995709|BG000|Baseline|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
10988347|NCT00995709|BG001|Baseline|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
10988348|NCT00995709|BG002|Baseline|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
10988349|NCT00995709|BG003|Baseline|Total|Total of all reporting groups
10988350|NCT00995709|FG000|Participant Flow|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
10988351|NCT00995709|FG001|Participant Flow|AIN457C 300 mg Monthly Dosage Regimen|"AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.~One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication"
10988352|NCT00995709|FG002|Participant Flow|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
10988353|NCT00995709|OG000|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
10988354|NCT00995709|OG001|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
10988355|NCT00995709|OG002|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
10988356|NCT00995709|EG000|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
10988357|NCT00995709|EG001|Reported Event|AIN457 300mg Monthly|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
10988358|NCT00995709|EG002|Reported Event|Placebo|Placebo was administered in 2 s.c. injections
10988359|NCT00995722|BG000|Baseline|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
10988360|NCT00995722|BG001|Baseline|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
10988361|NCT00995722|BG002|Baseline|Total|Total of all reporting groups
10988362|NCT00995722|FG000|Participant Flow|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
10988363|NCT00995722|FG001|Participant Flow|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
10988364|NCT00995722|OG000|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
10988365|NCT00995722|OG001|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
10988366|NCT00995722|EG000|Reported Event|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
10988367|NCT00995722|EG001|Reported Event|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
10988368|NCT00995761|BG000|Baseline|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
10988369|NCT00995761|FG000|Participant Flow|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
11348195|NCT04206384|BG000|Baseline|Treatment Group|"Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2.~Ultrasound: Ultimate Contour Body Sculpting Device"
11348196|NCT04206384|FG000|Participant Flow|Treatment Group|"Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2.~Ultrasound: Ultimate Contour Body Sculpting Device"
10988370|NCT00995761|OG000|Outcome|Biweekly Schedule of Docetaxel and Cisplatin|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC.
10988371|NCT00995761|EG000|Reported Event|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
10988372|NCT00995774|BG000|Baseline|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
10988373|NCT00995774|BG001|Baseline|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
10988374|NCT00995774|BG002|Baseline|Total|Total of all reporting groups
10988375|NCT00995774|FG000|Participant Flow|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
10988376|NCT00995774|FG001|Participant Flow|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
10988377|NCT00995774|OG000|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
10988378|NCT00995774|OG001|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
10988379|NCT00995774|EG000|Reported Event|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
10988380|NCT00995774|EG001|Reported Event|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
10988381|NCT00995865|BG000|Baseline|High Dose Group|Two groups of 24 subjects each, (one arm called a high dose group, the other a Mid-Dose group) were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for the (mid dose).
10988382|NCT00995865|BG001|Baseline|Mid-Dose Group|Two groups of 24 subjects each were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for this (mid dose) group.
10988383|NCT00995865|BG002|Baseline|Placebo Group|This third group of 12 subjects were to receive a placebo (0.9% normal saline for injection).
10988384|NCT00995865|BG003|Baseline|Total|Total of all reporting groups
10988385|NCT00995865|FG000|Participant Flow|High Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
10988386|NCT00995865|FG001|Participant Flow|Mid Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
10988387|NCT00995865|FG002|Participant Flow|Placebo|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
10988388|NCT00995865|OG000|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~24 Subjects were examined in this group."
10988389|NCT00995865|OG001|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
10988390|NCT00995865|OG002|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.~12 Subjects were examined in this group."
10988391|NCT00995865|OG000|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
10988392|NCT00995865|OG002|Outcome|Placebo Group|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
10988393|NCT00995865|EG000|Reported Event|High Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~First injection."
10988394|NCT00995865|EG001|Reported Event|Mid Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~First injection."
10988395|NCT00995865|EG002|Reported Event|Placebo First Injection|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9% First injection."
10988396|NCT00995865|EG003|Reported Event|High Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~Second injection at an interval of 21 days"
10988397|NCT00995865|EG004|Reported Event|Mid Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~Second injection."
10988398|NCT00995865|EG005|Reported Event|Placebo Second Injection|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9% Second injection."
10988399|NCT00995904|BG000|Baseline|All Patients|All patients that were enrolled in the study.
10988400|NCT00995904|FG000|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
10988401|NCT00995904|FG001|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
10988402|NCT00995904|FG002|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
10988403|NCT00995904|FG003|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
10988404|NCT00995904|FG004|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
11336382|NCT03565666|OG000|Outcome|Days 1-7 of RCT|36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Half of the subjects (n=18) will wear the Dexcom G5 continuous glucose monitor (CGM) and the other half will wear a Senseonics Eversense CGM.
10988405|NCT00995904|FG005|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
10988406|NCT00995904|OG000|Outcome|21ug MAP0020|21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
10988407|NCT00995904|OG001|Outcome|42ug MAP0020|42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
10988408|NCT00995904|OG002|Outcome|84ug MAP0020|84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
10988409|NCT00995904|OG000|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
10988410|NCT00995904|OG001|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
10988411|NCT00995904|OG002|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
10988412|NCT00995904|EG000|Reported Event|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
10988413|NCT00995904|EG001|Reported Event|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
11348197|NCT04206384|OG000|Outcome|Treatment Group|"Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2.~Ultrasound: Ultimate Contour Body Sculpting Device"
10988414|NCT00995904|EG002|Reported Event|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
10988415|NCT00995930|BG000|Baseline|Placebo|SQ monthly
10988416|NCT00995930|BG001|Baseline|ACZ885|150 mg SQ monthly
10988417|NCT00995930|BG002|Baseline|Total|Total of all reporting groups
10988418|NCT00995930|FG000|Participant Flow|Placebo|SQ monthly
10988419|NCT00995930|FG001|Participant Flow|ACZ885|150 mg SQ monthly
10988420|NCT00995930|OG000|Outcome|Placebo|SQ monthly
10988421|NCT00995930|OG001|Outcome|ACZ885|150 mg SQ monthly
10988422|NCT00995930|OG000|Outcome|ACZ885|150 mg SQ monthly
10988423|NCT00995930|EG000|Reported Event|ACZ885 150mg|ACZ885 150mg
10988424|NCT00995930|EG001|Reported Event|Placebo|SQ monthly
10988425|NCT00996034|BG000|Baseline|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
10988426|NCT00996034|FG000|Participant Flow|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
10988427|NCT00996034|OG000|Outcome|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
10988428|NCT00996034|EG000|Reported Event|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
10988429|NCT00996125|BG000|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10988430|NCT00996125|BG001|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10988431|NCT00996125|BG002|Baseline|Total|Total of all reporting groups
10988432|NCT00996125|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10988433|NCT00996125|FG001|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10988434|NCT00996125|OG000|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10988435|NCT00996125|OG001|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10988436|NCT00996125|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10988437|NCT00996125|EG001|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10988438|NCT00996164|BG000|Baseline|Flibanserin 100 mg|flibanserin 100mg po qd
10988439|NCT00996164|BG001|Baseline|Placebo|placebo 1 tab po qd
10988440|NCT00996164|BG002|Baseline|Total|Total of all reporting groups
10988441|NCT00996164|FG000|Participant Flow|Flibanserin 100 mg|flibanserin 100mg po qd
10988442|NCT00996164|FG001|Participant Flow|Placebo|placebo 1 tab po qd
10988443|NCT00996164|OG000|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd~Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
10988444|NCT00996164|OG001|Outcome|Placebo|"placebo 1 tab po qd~Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
10988445|NCT00996164|EG000|Reported Event|Flibanserin 100 mg|flibanserin 100mg po qd
10988446|NCT00996164|EG001|Reported Event|Placebo|placebo 1 tab po qd
10988447|NCT00996203|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
10988448|NCT00996203|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (but not more than 800 mg), intravenously (IV), every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
10988449|NCT00996203|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
10988450|NCT00996203|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
10988451|NCT00996203|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
10988452|NCT00996216|BG000|Baseline|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
10988453|NCT00996216|FG000|Participant Flow|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
10988454|NCT00996216|OG000|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
10988455|NCT00996216|EG000|Reported Event|Eltrombopag (Part 1)|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study.
10988456|NCT00996216|EG001|Reported Event|Eltrombopag (Part 2)|Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
10988457|NCT00996281|BG000|Baseline|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
10988458|NCT00996281|BG001|Baseline|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
10988459|NCT00996281|BG002|Baseline|Total|Total of all reporting groups
10988460|NCT00996281|FG000|Participant Flow|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
11336383|NCT03565666|EG000|Reported Event|Usual Care Arm|"Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm~Usual care: Usual care"
10988461|NCT00996281|FG001|Participant Flow|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
10988462|NCT00996281|OG000|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
10988463|NCT00996281|OG001|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
10988464|NCT00996281|EG000|Reported Event|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
10988465|NCT00996281|EG001|Reported Event|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
10988466|NCT00996307|BG000|Baseline|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988467|NCT00996307|BG001|Baseline|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988468|NCT00996307|BG002|Baseline|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988469|NCT00996307|BG003|Baseline|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988470|NCT00996307|BG004|Baseline|Total|Total of all reporting groups
10988471|NCT00996307|FG000|Participant Flow|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988472|NCT00996307|FG001|Participant Flow|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988473|NCT00996307|FG002|Participant Flow|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988474|NCT00996307|FG003|Participant Flow|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988475|NCT00996307|OG000|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988476|NCT00996307|OG001|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988477|NCT00996307|OG002|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988478|NCT00996307|OG003|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988479|NCT00996307|OG000|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988480|NCT00996307|OG001|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988481|NCT00996307|OG002|Outcome|7.5_(50)MF59-No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988482|NCT00996307|OG003|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988483|NCT00996307|OG004|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988484|NCT00996307|OG005|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988485|NCT00996307|OG006|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988486|NCT00996307|OG007|Outcome|15_(0)MF59-Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988487|NCT00996307|OG002|Outcome|7.5_(50)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988488|NCT00996307|OG007|Outcome|15_(0)MF59-with Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988489|NCT00996307|OG000|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988490|NCT00996307|OG001|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988491|NCT00996307|OG002|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988492|NCT00996307|OG003|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988493|NCT00996307|OG004|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988494|NCT00996307|OG005|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988495|NCT00996307|OG006|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988496|NCT00996307|OG007|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988497|NCT00996307|EG000|Reported Event|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988498|NCT00996307|EG001|Reported Event|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988499|NCT00996307|EG002|Reported Event|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
10988500|NCT00996307|EG003|Reported Event|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
10988501|NCT00996346|BG000|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
10988502|NCT00996346|BG001|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
10988503|NCT00996346|BG002|Baseline|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
10988504|NCT00996346|BG003|Baseline|Total|Total of all reporting groups
10988505|NCT00996346|FG000|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
10988506|NCT00996346|FG001|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
10988507|NCT00996346|FG002|Participant Flow|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
10988508|NCT00996346|OG000|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).~In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.~The treatment consists of:~Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.~The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
10988509|NCT00996346|EG000|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
11348198|NCT04206384|EG000|Reported Event|Treatment Group|"Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2.~Ultrasound: Ultimate Contour Body Sculpting Device"
10988510|NCT00996346|EG001|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
10988511|NCT00996346|EG002|Reported Event|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
10988512|NCT00996372|BG000|Baseline|Flibanserin|
10988513|NCT00996372|BG001|Baseline|Placebo|
10988514|NCT00996372|BG002|Baseline|Total|Total of all reporting groups
10988515|NCT00996372|FG000|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
10988516|NCT00996372|FG001|Participant Flow|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
10988517|NCT00996372|OG000|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
10988518|NCT00996372|OG001|Outcome|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
10988519|NCT00996372|OG000|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
10988520|NCT00996372|OG001|Outcome|Placebo|"placebo one tablet po qd~placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
10988521|NCT00996372|EG000|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
10988522|NCT00996372|EG001|Reported Event|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
10988523|NCT00996437|BG000|Baseline|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
10988524|NCT00996437|BG001|Baseline|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
10988525|NCT00996437|BG002|Baseline|Total|Total of all reporting groups
10988526|NCT00996437|FG000|Participant Flow|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
10988527|NCT00996437|FG001|Participant Flow|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
10988528|NCT00996437|OG000|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
10988529|NCT00996437|OG001|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
10988530|NCT00996437|EG000|Reported Event|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
10988531|NCT00996437|EG001|Reported Event|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
10988532|NCT00996476|BG000|Baseline|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988533|NCT00996476|BG001|Baseline|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988534|NCT00996476|BG002|Baseline|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
10988535|NCT00996476|BG003|Baseline|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988536|NCT00996476|BG004|Baseline|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
10988537|NCT00996476|BG005|Baseline|Total|Total of all reporting groups
10988538|NCT00996476|FG000|Participant Flow|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988539|NCT00996476|FG001|Participant Flow|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988540|NCT00996476|FG002|Participant Flow|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
10988541|NCT00996476|FG003|Participant Flow|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988542|NCT00996476|FG004|Participant Flow|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
10988543|NCT00996476|OG000|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
10988544|NCT00996476|OG001|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
10988545|NCT00996476|OG002|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
10988546|NCT00996476|OG000|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988547|NCT00996476|OG001|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988548|NCT00996476|OG002|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
10988549|NCT00996476|OG003|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988550|NCT00996476|OG004|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
10988551|NCT00996476|OG004|Outcome|All TMC435|TMC435 50 mg or 100 mg capsule orally once daily for 12 or 24 weeks
10988552|NCT00996476|OG005|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
10988553|NCT00996476|EG000|Reported Event|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988554|NCT00996476|EG001|Reported Event|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988555|NCT00996476|EG002|Reported Event|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
10988556|NCT00996476|EG003|Reported Event|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
10988557|NCT00996476|EG004|Reported Event|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
10988558|NCT00996489|BG000|Baseline|Coaptite|Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
10988559|NCT00996489|FG000|Participant Flow|Coaptite|Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
10988560|NCT00996489|OG000|Outcome|Coaptite|Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
10988561|NCT00996489|EG000|Reported Event|Coaptite|Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
10988562|NCT00996580|BG000|Baseline|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
10988563|NCT00996580|FG000|Participant Flow|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
10988564|NCT00996580|OG000|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
10988565|NCT00996580|OG001|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
10988566|NCT00996580|OG002|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
10988567|NCT00996580|OG000|Outcome|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
10988568|NCT00996580|EG000|Reported Event|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
10988569|NCT00996593|BG000|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10988570|NCT00996593|FG000|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10988571|NCT00996593|OG000|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10988572|NCT00996593|EG000|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
10988573|NCT00996606|BG000|Baseline|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
10988574|NCT00996606|FG000|Participant Flow|Tocilizumab in Active Rheumatoid Arthritis (RA)|Participants with active RA received tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
10988575|NCT00996606|OG000|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
10988576|NCT00996606|EG000|Reported Event|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
10988577|NCT00996632|BG000|Baseline|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
10988578|NCT00996632|BG001|Baseline|Conventional|Patients were operated by a conventional diatherm knife
10988579|NCT00996632|BG002|Baseline|Total|Total of all reporting groups
10988580|NCT00996632|FG000|Participant Flow|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
10988581|NCT00996632|FG001|Participant Flow|Conventional|Patients were operated by a conventional diatherm knife
10988582|NCT00996632|OG000|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
10988583|NCT00996632|OG001|Outcome|Conventional|Patients were operated by a conventional diatherm knife
10988584|NCT00996632|EG000|Reported Event|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
10988585|NCT00996632|EG001|Reported Event|Conventional|Patients were operated by a conventional diatherm knife
10988586|NCT00996658|BG000|Baseline|Placebo Tablet|
10988587|NCT00996658|BG001|Baseline|Linagliptin 5 mg Tablet|
10988588|NCT00996658|BG002|Baseline|Total|Total of all reporting groups
10988589|NCT00996658|FG000|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
10988590|NCT00996658|FG001|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
10988591|NCT00996658|OG000|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
10988592|NCT00996658|OG001|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
10988593|NCT00996658|EG000|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
10988594|NCT00996658|EG001|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
10988595|NCT00996736|BG000|Baseline|Topical Natamycin|
10988596|NCT00996736|BG001|Baseline|Topical Voriconazole|
10988597|NCT00996736|BG002|Baseline|Total|Total of all reporting groups
10988598|NCT00996736|FG000|Participant Flow|Topical Natamycin|
10988599|NCT00996736|FG001|Participant Flow|Topical Voriconazole|
10988600|NCT00996736|OG000|Outcome|Topical Natamycin|
10988601|NCT00996736|OG001|Outcome|Topical Voriconazole|
10988602|NCT00996736|EG000|Reported Event|Topical Natamycin|
10988603|NCT00996736|EG001|Reported Event|Topical Voriconazole|
10988604|NCT00996775|BG000|Baseline|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
10988605|NCT00996775|BG001|Baseline|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
10988606|NCT00996775|BG002|Baseline|Total|Total of all reporting groups
10988607|NCT00996775|FG000|Participant Flow|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
10988608|NCT00996775|FG001|Participant Flow|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
10988609|NCT00996775|OG000|Outcome|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
10988610|NCT00996775|OG001|Outcome|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
10988611|NCT00996775|EG000|Reported Event|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
10988612|NCT00996775|EG001|Reported Event|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
10988613|NCT00996801|BG000|Baseline|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988614|NCT00996801|BG001|Baseline|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988615|NCT00996801|BG002|Baseline|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988616|NCT00996801|BG003|Baseline|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988617|NCT00996801|BG004|Baseline|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988618|NCT00996801|BG005|Baseline|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988619|NCT00996801|BG006|Baseline|Total|Total of all reporting groups
10988620|NCT00996801|FG000|Participant Flow|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988621|NCT00996801|FG001|Participant Flow|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988622|NCT00996801|FG002|Participant Flow|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988623|NCT00996801|FG003|Participant Flow|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988624|NCT00996801|FG004|Participant Flow|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988625|NCT00996801|FG005|Participant Flow|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988626|NCT00996801|OG000|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
10988627|NCT00996801|OG001|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
10988628|NCT00996801|OG002|Outcome|MK-5442 7.5mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
10988629|NCT00996801|OG003|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
10988630|NCT00996801|OG004|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
10988631|NCT00996801|OG002|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
10988632|NCT00996801|OG004|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
10988633|NCT00996801|OG005|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
10988634|NCT00996801|EG000|Reported Event|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988635|NCT00996801|EG001|Reported Event|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988636|NCT00996801|EG002|Reported Event|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988637|NCT00996801|EG003|Reported Event|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988638|NCT00996801|EG004|Reported Event|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988639|NCT00996801|EG005|Reported Event|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
10988640|NCT00996840|BG000|Baseline|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
10988641|NCT00996840|BG001|Baseline|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
10988642|NCT00996840|BG002|Baseline|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
10988643|NCT00996840|BG003|Baseline|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
10988644|NCT00996840|BG004|Baseline|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
10988645|NCT00996840|BG005|Baseline|Total|Total of all reporting groups
10988646|NCT00996840|FG000|Participant Flow|Combined Placebo|Eligible participants received matching placebo intravenous (IV) infusion over 4 hours (h) or 24 h for 3 days
10988647|NCT00996840|FG001|Participant Flow|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 milligrams (mg), IV infusion over 4h for 3 days
10988648|NCT00996840|FG002|Participant Flow|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
10988649|NCT00996840|FG003|Participant Flow|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
10988650|NCT00996840|FG004|Participant Flow|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
10988651|NCT00996840|OG000|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
10988652|NCT00996840|OG001|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
10988653|NCT00996840|OG002|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
10988654|NCT00996840|OG003|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
10988655|NCT00996840|OG004|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
10988656|NCT00996840|OG000|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
10988657|NCT00996840|OG001|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
10988658|NCT00996840|OG002|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
10988659|NCT00996840|OG003|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
10988660|NCT00996840|EG000|Reported Event|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
10988661|NCT00996840|EG001|Reported Event|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
10988662|NCT00996840|EG002|Reported Event|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
10988663|NCT00996840|EG003|Reported Event|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
10988664|NCT00996840|EG004|Reported Event|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
10988665|NCT00996892|BG000|Baseline|All Participants|All participants who received cobimetinib and pictilisib in any dose combination until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988666|NCT00996892|FG000|Participant Flow|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 1 (S1 C1): Participants received a single oral dose of pictilisib 80 milligrams (mg) capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988667|NCT00996892|FG001|Participant Flow|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 2 (S1 C2): Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988668|NCT00996892|FG002|Participant Flow|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 3 (S1 C3): Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11336384|NCT03565666|EG001|Reported Event|iLet With Humalog/Novolog Arm|Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
10988669|NCT00996892|FG003|Participant Flow|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 4 (S1 C4): Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988670|NCT00996892|FG004|Participant Flow|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1 Cohort 5 (S1 C5): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988671|NCT00996892|FG005|Participant Flow|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6 (S1 C6): Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988672|NCT00996892|FG006|Participant Flow|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6A (S1 C6A): Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988673|NCT00996892|FG007|Participant Flow|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort A (S1A CA): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988674|NCT00996892|FG008|Participant Flow|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort B (S1A CB): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988675|NCT00996892|FG009|Participant Flow|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort C (S1A CC): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988676|NCT00996892|FG010|Participant Flow|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort D (S1A CD): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988677|NCT00996892|FG011|Participant Flow|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort E (S1A CE): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988678|NCT00996892|FG012|Participant Flow|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort F (S1A CF): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988679|NCT00996892|FG013|Participant Flow|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort G (S1A CG): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988680|NCT00996892|FG014|Participant Flow|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort AX (S1B CAX): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988681|NCT00996892|FG015|Participant Flow|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort BX (S1B CBX): Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988682|NCT00996892|FG016|Participant Flow|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort CX (S1B CCX): Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988683|NCT00996892|FG017|Participant Flow|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort DX (S1B CDX): Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988684|NCT00996892|FG018|Participant Flow|S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 2 (S2) expansion cohort: Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non-small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).
10988685|NCT00996892|FG019|Participant Flow|S2A Expansion: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 2A (S2A) expansion cohort: Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.
10988686|NCT00996892|OG000|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988687|NCT00996892|OG001|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988688|NCT00996892|OG002|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988689|NCT00996892|OG003|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988690|NCT00996892|OG004|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988691|NCT00996892|OG005|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988692|NCT00996892|OG006|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988693|NCT00996892|OG007|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988694|NCT00996892|OG008|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988695|NCT00996892|OG009|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988696|NCT00996892|OG010|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988697|NCT00996892|OG011|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988698|NCT00996892|OG012|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988699|NCT00996892|OG013|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11336385|NCT03565666|EG002|Reported Event|iLet Using Fiasp Arm|Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
10988700|NCT00996892|OG014|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988701|NCT00996892|OG015|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988702|NCT00996892|OG016|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988703|NCT00996892|OG017|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988704|NCT00996892|OG000|Outcome|All Participants - Stages 1, 1A, 1B|All participants who received cobimetinib and pictilisib in any dose combination during Stages 1, 1A, and 1B, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988705|NCT00996892|OG000|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988706|NCT00996892|OG001|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988707|NCT00996892|OG002|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988708|NCT00996892|OG003|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988709|NCT00996892|OG004|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988710|NCT00996892|OG005|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988711|NCT00996892|OG006|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988712|NCT00996892|OG000|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988713|NCT00996892|OG001|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988714|NCT00996892|OG002|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988715|NCT00996892|OG003|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988716|NCT00996892|OG000|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988717|NCT00996892|OG001|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988718|NCT00996892|OG002|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988719|NCT00996892|OG003|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988720|NCT00996892|OG000|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988721|NCT00996892|OG001|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988722|NCT00996892|OG002|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988723|NCT00996892|OG003|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988724|NCT00996892|OG004|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988725|NCT00996892|OG003|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
10988726|NCT00996892|OG010|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
10988727|NCT00996892|EG000|Reported Event|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988728|NCT00996892|EG001|Reported Event|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988729|NCT00996892|EG002|Reported Event|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988730|NCT00996892|EG003|Reported Event|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
10988731|NCT00996892|EG004|Reported Event|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988732|NCT00996892|EG005|Reported Event|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988733|NCT00996892|EG006|Reported Event|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988734|NCT00996892|EG007|Reported Event|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988735|NCT00996892|EG008|Reported Event|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988736|NCT00996892|EG009|Reported Event|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988737|NCT00996892|EG010|Reported Event|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
10988738|NCT00996892|EG011|Reported Event|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988739|NCT00996892|EG012|Reported Event|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988740|NCT00996892|EG013|Reported Event|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988741|NCT00996892|EG014|Reported Event|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988742|NCT00996892|EG015|Reported Event|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988743|NCT00996892|EG016|Reported Event|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988744|NCT00996892|EG017|Reported Event|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
10988745|NCT00996918|BG000|Baseline|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988746|NCT00996918|BG001|Baseline|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988747|NCT00996918|BG002|Baseline|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988748|NCT00996918|BG003|Baseline|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988749|NCT00996918|BG004|Baseline|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988750|NCT00996918|BG005|Baseline|Total|Total of all reporting groups
10988751|NCT00996918|FG000|Participant Flow|Placebo/Bapineuzumab 0.5 Milligram/Kilogram(mg/kg)|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988752|NCT00996918|FG001|Participant Flow|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988753|NCT00996918|FG002|Participant Flow|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988754|NCT00996918|FG003|Participant Flow|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988755|NCT00996918|FG004|Participant Flow|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988756|NCT00996918|OG000|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988757|NCT00996918|OG001|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988758|NCT00996918|OG002|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988759|NCT00996918|OG003|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988760|NCT00996918|OG004|Outcome|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988761|NCT00996918|EG000|Reported Event|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988762|NCT00996918|EG001|Reported Event|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988763|NCT00996918|EG002|Reported Event|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988764|NCT00996918|EG003|Reported Event|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988765|NCT00996918|EG004|Reported Event|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
10988766|NCT00996931|BG000|Baseline|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
10988767|NCT00996931|FG000|Participant Flow|Lenalidomide|Six patients will receive oral 2.5 mg daily for 12 weeks
10988768|NCT00996931|OG000|Outcome|Lenalidomide|Six subjects received oral 2.5 mg daily for 12 weeks
10988769|NCT00996931|OG000|Outcome|Lenalidomide|oral 25 mg daily for 12 weeks
10988770|NCT00996931|EG000|Reported Event|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
10988771|NCT00996944|BG000|Baseline|Ropinirole IR-Ropinirole IR|"Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting much improved or very much improved in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period."
10988772|NCT00996944|BG001|Baseline|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
10988773|NCT00996944|BG002|Baseline|Total|Total of all reporting groups
11007328|NCT01090414|BG001|Baseline|101-07|Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007329|NCT01090414|BG002|Baseline|101-08|Participants with CLL or iNHL (specifically, small lymphocytic lymphoma (SLL)) received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.
10988774|NCT00996944|FG000|Participant Flow|Ropinirole IR-Ropinirole IR|"Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting much improved or very much improved in the investigator/subinvestigator-assessed Clinical Global Impression-Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period."
10988775|NCT00996944|FG001|Participant Flow|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
10988776|NCT00996944|OG000|Outcome|Ropinirole IR-Ropinirole IR|"Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting much improved or very much improved in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period."
10988777|NCT00996944|OG001|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
10988778|NCT00996944|OG000|Outcome|Ropinirole IR-Ropinirole IR|"Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting much improved or very much improved in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period."
10988779|NCT00996944|OG000|Outcome|Ropinirole IR-Ropinirole IR|"Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting much improved or very much improved in the investigator/subinvestigator-assessed Clinical Global Impression-Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period."
10988780|NCT00996944|EG000|Reported Event|Ropinirole IR-Ropinirole IR|"Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting much improved or very much improved in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period."
10988781|NCT00996944|EG001|Reported Event|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
10988782|NCT00996996|BG000|Baseline|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
11348199|NCT04204200|BG000|Baseline|Allocated to Conventional Vitamin C (n= 22)|Participant intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery).
11348200|NCT04204200|BG001|Baseline|Allocated to Liposomal Vitamin C (n= 22)|Participant intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days.
11348201|NCT04204200|BG002|Baseline|Allocated to Placebo (n= 22)|Participant intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure).
11348202|NCT04204200|BG003|Baseline|Total|Total of all reporting groups
11007330|NCT01090414|BG003|Baseline|101-10|Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007331|NCT01090414|BG004|Baseline|Total|Total of all reporting groups
11336410|NCT03566238|FG000|Participant Flow|A4250 Low Dose|"Capsules for oral administration (40 ug/kg) once daily for 24 weeks~A4250 (odevixibat): A4250 is a small molecule and selective inhibitor of IBAT."
11336411|NCT03566238|FG001|Participant Flow|A4250 High Dose|"Capsules for oral administration (120 ug/kg) once daily for 24 weeks~A4250 (odevixibat): A4250 is a small molecule and selective inhibitor of IBAT."
11336412|NCT03566238|FG002|Participant Flow|Placebo|"Capsules for oral administration (to match active) once daily for 24 weeks~Placebo: Placebo identical in appearance to active drug (A4250)."
11336413|NCT03566238|OG000|Outcome|A4250 Low Dose|"Capsules for oral administration (40 ug/kg) once daily for 24 weeks~A4250 (odevixibat): A4250 is a small molecule and selective inhibitor of IBAT."
11336414|NCT03566238|OG001|Outcome|A4250 High Dose|"Capsules for oral administration (120 ug/kg) once daily for 24 weeks~A4250 (odevixibat): A4250 is a small molecule and selective inhibitor of IBAT."
11336415|NCT03566238|OG002|Outcome|Placebo|"Capsules for oral administration (to match active) once daily for 24 weeks~Placebo: Placebo identical in appearance to active drug (A4250)."
11336416|NCT03566238|EG000|Reported Event|A4250 Low Dose|"Capsules for oral administration (40 ug/kg) once daily for 24 weeks~A4250 (odevixibat): A4250 is a small molecule and selective inhibitor of IBAT."
11336417|NCT03566238|EG001|Reported Event|A4250 High Dose|"Capsules for oral administration (120 ug/kg) once daily for 24 weeks~A4250 (odevixibat): A4250 is a small molecule and selective inhibitor of IBAT."
11336418|NCT03566238|EG002|Reported Event|Placebo|"Capsules for oral administration (to match active) once daily for 24 weeks~Placebo: Placebo identical in appearance to active drug (A4250)."
11336419|NCT03566485|BG000|Baseline|Phase 2 (Atezolizumab, Cobimetinib)|"Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Atezolizumab: Given by IV~Cobimetinib: Given by mouth"
11336420|NCT03566485|BG001|Baseline|Phase 1b - (Atezolizumab, Idasanutlin)|"Atezolizumab: Given by IV~Idasanutlin: Given by mouth"
11336421|NCT03566485|BG002|Baseline|Total|Total of all reporting groups
11336422|NCT03566485|FG000|Participant Flow|Phase 2 (Atezolizumab, Cobimetinib)|"Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Atezolizumab: Given by IV~Cobimetinib: Given by mouth"
11336423|NCT03566485|FG001|Participant Flow|Phase 1b - (Atezolizumab, Idasanutlin)|"Atezolizumab: Given by IV~Idasanutlin: Given by mouth"
11336424|NCT03566485|OG000|Outcome|Phase 1b - (Atezolizumab, Idasanutlin)|"Atezolizumab: Given by IV~Idasanutlin: Given by mouth"
11336425|NCT03566485|OG000|Outcome|Phase 2 (Atezolizumab, Cobimetinib)|"Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Atezolizumab: Given by IV~Cobimetinib: Given by mouth"
11336426|NCT03566485|EG000|Reported Event|Phase 2 (Atezolizumab, Cobimetinib)|"Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Atezolizumab: Given by IV~Cobimetinib: Given by mouth"
11336427|NCT03566485|EG001|Reported Event|Phase 1b - (Atezolizumab, Idasanutlin)|"Atezolizumab: Given by IV~Idasanutlin: Given by mouth"
11336428|NCT03566550|BG000|Baseline|Cystic Fibrosis|"people with cystic fibrosis~MRI scans: Repeated MRI scans imaging digestion of standard meals"
11336429|NCT03566550|BG001|Baseline|Control|"people without cystic fibrosis~MRI scans: Repeated MRI scans imaging digestion of standard meals"
11336430|NCT03566550|BG002|Baseline|Total|Total of all reporting groups
11336431|NCT03566550|FG000|Participant Flow|Cystic Fibrosis|"people with cystic fibrosis~MRI scans: Repeated MRI scans imaging digestion of standard meals"
11336432|NCT03566550|FG001|Participant Flow|Control|"people without cystic fibrosis~MRI scans: Repeated MRI scans imaging digestion of standard meals"
11336433|NCT03566550|OG000|Outcome|Cystic Fibrosis|"people with cystic fibrosis~MRI scans: Repeated MRI scans imaging digestion of standard meals"
11336434|NCT03566550|OG001|Outcome|Control|"people without cystic fibrosis~MRI scans: Repeated MRI scans imaging digestion of standard meals"
11336435|NCT03566550|EG000|Reported Event|Cystic Fibrosis|"people with cystic fibrosis~MRI scans: Repeated MRI scans imaging digestion of standard meals"
11336436|NCT03566550|EG001|Reported Event|Control|"people without cystic fibrosis~MRI scans: Repeated MRI scans imaging digestion of standard meals"
11336437|NCT03566680|BG000|Baseline|Orthokeratology Group|"All subjects will be fit in orthokeratology contact lenses.~Orthokeratology: Orthokeratology is a type of contact lens that is worn over night to reduce refractive error, so patients do not need to wear vision correction during the day."
11336438|NCT03566680|FG000|Participant Flow|Orthokeratology Group|"All subjects will be fit in orthokeratology contact lenses.~Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day."
11336439|NCT03566680|OG000|Outcome|Orthokeratology Group|"All subjects will be fit in orthokeratology contact lenses.~Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day."
10988783|NCT00996996|FG000|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10988784|NCT00996996|OG000|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10988785|NCT00996996|EG000|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
10988786|NCT00997035|BG000|Baseline|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
10988787|NCT00997035|BG001|Baseline|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
10988788|NCT00997035|BG002|Baseline|Total|Total of all reporting groups
10988789|NCT00997035|FG000|Participant Flow|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
10988790|NCT00997035|FG001|Participant Flow|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
10988791|NCT00997035|OG000|Outcome|Oral Voriconazole|oral voriconazole plus topical antifungal agents
10988792|NCT00997035|OG001|Outcome|Oral Placebo|oral placebo plus topical antifungal agents
10988793|NCT00997035|OG000|Outcome|Oral Voriconazole|Oral Voriconazole plus topical antifungal agents
10988794|NCT00997035|OG001|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
10988795|NCT00997035|OG000|Outcome|Oral Voriconazole|Oral voriconazole treated participants
10988796|NCT00997035|OG001|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agent
10988797|NCT00997035|OG000|Outcome|Oral Voriconazole|oral voriconazole plus topical antifungal
10988798|NCT00997035|OG001|Outcome|Oral Placebo|oral placebo plus topical antifungal
10988799|NCT00997035|OG000|Outcome|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
10988800|NCT00997035|OG001|Outcome|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
11007332|NCT01090414|FG000|Participant Flow|101-02|Participants with chronic lymphocytic leukemia (CLL), indolent non-Hodgkin lymphoma (iNHL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), or multiple myeloma (MM) received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
10988801|NCT00997035|OG000|Outcome|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
10988802|NCT00997035|OG001|Outcome|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
10988803|NCT00997035|EG000|Reported Event|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
10988804|NCT00997035|EG001|Reported Event|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
10988805|NCT00997113|BG000|Baseline|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
10988806|NCT00997113|BG001|Baseline|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
10988807|NCT00997113|BG002|Baseline|Total|Total of all reporting groups
10988808|NCT00997113|FG000|Participant Flow|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
10988809|NCT00997113|FG001|Participant Flow|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
10988810|NCT00997113|OG000|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
10988811|NCT00997113|OG001|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
10988812|NCT00997113|EG000|Reported Event|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
10988813|NCT00997113|EG001|Reported Event|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
10988814|NCT00997126|BG000|Baseline|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
10988815|NCT00997126|BG001|Baseline|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
10988816|NCT00997126|BG002|Baseline|Total|Total of all reporting groups
10988817|NCT00997126|FG000|Participant Flow|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
10988818|NCT00997126|FG001|Participant Flow|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
10988819|NCT00997126|OG000|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
10988820|NCT00997126|OG001|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
10988821|NCT00997126|EG000|Reported Event|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
10988822|NCT00997126|EG001|Reported Event|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
10988823|NCT00997139|BG000|Baseline|Treatment Group|Baseline culture positive for Staphylococcus aureus
10988824|NCT00997139|FG000|Participant Flow|All Subjects|
10988825|NCT00997139|OG000|Outcome|All Subjects|All subjects enrolled
10988826|NCT00997139|OG000|Outcome|MSSA|Baseline culture positive for methicillin-susceptible staphylococcus aureus
10988827|NCT00997139|OG000|Outcome|MRSA|Subjects with Baseline culture positive for methicillin-resistant Staphylococcus aureus
10988828|NCT00997139|EG000|Reported Event|All Subjects|
10988829|NCT00997204|BG000|Baseline|Non-Naive Patients|Patients who previously treated with icatibant in clinical studies or with commercial Firazyr® and got the treatment during the self-administered phase
10988830|NCT00997204|BG001|Baseline|Naive Patients|Patients who had never received icatibant and treated in both the Naive treatment phase and the Self-administered phase
10988831|NCT00997204|BG002|Baseline|Total|Total of all reporting groups
10988832|NCT00997204|FG000|Participant Flow|Naive Subjects/ Naive Treatment Phase|Patients who had never received icatibant before this phase, got treatment of Acute HAE Attack with SC icatibant (30 mg)Administered at Site by Health Care Provider.
10988833|NCT00997204|FG001|Participant Flow|Non-Naive Subjects/ Self-administration Phase|Subjects who had received treatment for HAE with icatibant in previous clinical trials or had been previously treated with the marketed product Firazyr®, got Treatment of Acute HAE Attack with SC icatibant (30 mg)Self-Administered.
10988834|NCT00997204|OG000|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject. 3 subjects (of the original 25 enrolled in the naive treatment phase)self-administered icatibant while observed bu HCP, as opposed to having the HCP perform the injection. these data were not included in the naive treatment safety analyses.
10988835|NCT00997204|OG001|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
10988836|NCT00997204|OG002|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
10988837|NCT00997204|OG000|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
10988838|NCT00997204|OG002|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
10988839|NCT00997204|EG000|Reported Event|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
10988840|NCT00997204|EG001|Reported Event|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
10988841|NCT00997204|EG002|Reported Event|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
10988842|NCT00997243|BG000|Baseline|75 mg/m2 5-azacytidine (Vidaza, AZA) and 600 mg Lintuzumab|5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7 cycle 1 and all subsequent cycles. Lintuzumab 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22 for cycle 1 and 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy for all other subsequent cycles.
10988843|NCT00997243|FG000|Participant Flow|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
10988844|NCT00997243|OG000|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
10988845|NCT00997243|EG000|Reported Event|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
10988846|NCT00997321|BG000|Baseline|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
10988847|NCT00997321|BG001|Baseline|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
10988848|NCT00997321|BG002|Baseline|Total|Total of all reporting groups
10988849|NCT00997321|FG000|Participant Flow|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
10988850|NCT00997321|FG001|Participant Flow|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
10988851|NCT00997321|OG000|Outcome|Propofol|percentage of participants with respiratory depression
10988852|NCT00997321|OG001|Outcome|Ketamine|percentage of participants with respiratory depression
10988853|NCT00997321|OG000|Outcome|Propofol|time in minutes from the start of the procedure until the return of baseline mental status
10988854|NCT00997321|OG001|Outcome|Ketamine|time in minutes from the start of the procedure until the return of baseline mental status
10988855|NCT00997321|OG000|Outcome|Propofol|percentage of subjects reporting pain after the procedure who received propofol
10988856|NCT00997321|OG001|Outcome|Ketamine|percentage of subjects reporting pain after the procedure who received ketamine
10988857|NCT00997321|OG000|Outcome|Propofol|median depth of sedation by the observers assesment of alertness scale in the propofol group
10988858|NCT00997321|OG001|Outcome|Ketamine|median depth of sedation by the observers assesment of alertness scale in the ketamine group
10988859|NCT00997321|EG000|Reported Event|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
10988860|NCT00997321|EG001|Reported Event|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
10988861|NCT00997334|BG000|Baseline|Erlotinib|Patients receive standard dose of erlotinib 150mg daily with cycle length of 28 days; Patients are treated until disease progression or until unaccepted drug toxicity.
10988862|NCT00997334|FG000|Participant Flow|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
10988863|NCT00997334|OG000|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
10988864|NCT00997334|EG000|Reported Event|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
10988865|NCT00997373|BG000|Baseline|Letrozole Arm|Grade 1 or 2 endometrial cancer treated 3 weeks before hysterectomy of repeat biopsy. Letrozole 2.5 mg PO daily.
10988866|NCT00997373|BG001|Baseline|Control|No letrozole before hysterectomy
10988867|NCT00997373|BG002|Baseline|Total|Total of all reporting groups
10988868|NCT00997373|FG000|Participant Flow|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
10988869|NCT00997373|FG001|Participant Flow|Control|No treatment prior to hysterectomy
10988870|NCT00997373|OG000|Outcome|Letrozole|"letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks"
10988871|NCT00997373|OG001|Outcome|Control|no treatemtn prior to hysterectomy
10988872|NCT00997373|EG000|Reported Event|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
10988873|NCT00997373|EG001|Reported Event|Control|No treatment prior to hysterectomy
10988874|NCT00997425|BG000|Baseline|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
10988875|NCT00997425|FG000|Participant Flow|Arm 1 Door Cover; Floor Cover|The interventions were provided in the order door cover, then floor cover and then floor cover followed by door cover. After a baseline of 14 days the first Intervention (14 days) was provided, followed by baseline two for another 14 days followed by a second Intervention (14 days).
10988876|NCT00997425|OG000|Outcome|Door Cover|- a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape
10988877|NCT00997425|OG001|Outcome|Floor Cover|"a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door.-"
10988878|NCT00997425|EG000|Reported Event|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
10988879|NCT00997438|BG000|Baseline|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988880|NCT00997438|BG001|Baseline|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988881|NCT00997438|BG002|Baseline|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988882|NCT00997438|BG003|Baseline|Total|Total of all reporting groups
10988883|NCT00997438|FG000|Participant Flow|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988884|NCT00997438|FG001|Participant Flow|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
11348203|NCT04204200|FG000|Participant Flow|Allocated to Conventional Vitamin C (n= 22)|Participant intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery).
10988885|NCT00997438|FG002|Participant Flow|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988886|NCT00997438|OG000|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988887|NCT00997438|OG001|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988888|NCT00997438|OG002|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988889|NCT00997438|OG001|Outcome|MS - Relapsing Remitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988890|NCT00997438|EG000|Reported Event|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988891|NCT00997438|EG001|Reported Event|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988892|NCT00997438|EG002|Reported Event|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
10988893|NCT00997503|BG000|Baseline|TAXUS Liberté Post-Approval Study Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
10988894|NCT00997503|FG000|Participant Flow|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
10988895|NCT00997503|OG000|Outcome|TAXUS Libertē Post-Approval Study Enrolled Population|There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
10988896|NCT00997503|OG000|Outcome|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
10988897|NCT00997503|OG000|Outcome|Medically Treated Diabetic Population|Patients enrolled in the TAXUS Libertē Post-Approval Study with medically treated diabetes.
10988898|NCT00997503|OG000|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
10988899|NCT00997503|EG000|Reported Event|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
10988900|NCT00997516|BG000|Baseline|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
10988901|NCT00997516|BG001|Baseline|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
10988902|NCT00997516|BG002|Baseline|Total|Total of all reporting groups
10988903|NCT00997516|FG000|Participant Flow|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
10988904|NCT00997516|FG001|Participant Flow|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
10988905|NCT00997516|OG000|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
10988906|NCT00997516|OG001|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
10988907|NCT00997516|EG000|Reported Event|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
10988908|NCT00997516|EG001|Reported Event|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
10988909|NCT00997555|BG000|Baseline|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
10988910|NCT00997555|BG001|Baseline|Control Group|Standard treatment without scheduled bronchoscopy.
10988911|NCT00997555|BG002|Baseline|Total|Total of all reporting groups
10988912|NCT00997555|FG000|Participant Flow|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
10988913|NCT00997555|FG001|Participant Flow|Control Group|Standard treatment without scheduled bronchoscopy.
10988914|NCT00997555|OG000|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
10988915|NCT00997555|OG001|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
10988916|NCT00997555|EG000|Reported Event|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
10988917|NCT00997555|EG001|Reported Event|Control Group|Standard treatment without scheduled bronchoscopy.
10988918|NCT00997594|BG000|Baseline|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
10988919|NCT00997594|BG001|Baseline|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
10988920|NCT00997594|BG002|Baseline|Total|Total of all reporting groups
10988921|NCT00997594|FG000|Participant Flow|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
10988922|NCT00997594|FG001|Participant Flow|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
10988923|NCT00997594|OG000|Outcome|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
10988924|NCT00997594|OG001|Outcome|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
10988925|NCT00997594|EG000|Reported Event|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
10988926|NCT00997594|EG001|Reported Event|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
10988927|NCT00997620|BG000|Baseline|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
10988928|NCT00997620|BG001|Baseline|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
10988929|NCT00997620|BG002|Baseline|Total|Total of all reporting groups
10988930|NCT00997620|FG000|Participant Flow|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
10988931|NCT00997620|FG001|Participant Flow|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
10988932|NCT00997620|OG000|Outcome|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
10988933|NCT00997620|OG001|Outcome|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
10988934|NCT00997620|OG000|Outcome|Placebo Nasal Spray|One week placebo nasal spray followed by two weeks placebo nasal spray.
10988935|NCT00997620|OG001|Outcome|Fluticasone Furoate Nasal Spray|One week placebo nasal spray followed by two weeks fluticasone furoate nasal spray.
10988936|NCT00997620|OG000|Outcome|Placebo Nasal Spray|One week placebo nasal spray followed by two weeks placebo nasal spray
10988937|NCT00997620|EG000|Reported Event|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
10988938|NCT00997620|EG001|Reported Event|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
10988939|NCT00997672|BG000|Baseline|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
10988940|NCT00997672|BG001|Baseline|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
10988941|NCT00997672|BG002|Baseline|Total|Total of all reporting groups
10988942|NCT00997672|FG000|Participant Flow|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
10988943|NCT00997672|FG001|Participant Flow|Placebo|Placebo
10988944|NCT00997672|OG000|Outcome|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
10988945|NCT00997672|OG001|Outcome|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
10988946|NCT00997672|EG000|Reported Event|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
10988947|NCT00997672|EG001|Reported Event|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
10988948|NCT00997893|BG000|Baseline|Estradiol/Medroxyprogesterone Acetate|1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
10988949|NCT00997893|BG001|Baseline|Phytoestrogen|55 mg Novasoy pill b.i.d. (Total daily dose 110 mg)
10988950|NCT00997893|BG002|Baseline|Placebo|Placebo pill b.i.d. (0 mg Novasoy® and 0 mg estradiol)
10988951|NCT00997893|BG003|Baseline|Total|Total of all reporting groups
10988952|NCT00997893|FG000|Participant Flow|Estradiol/Medroxyprogesterone Acetate|1 mg/d oral Estradiol pill and 0 mg/d oral placebo pill for 12 weeks, followed by 10 mg/d oral medroxyprogesterone acetate (MPA) pill, for 10 days.
10988953|NCT00997893|FG001|Participant Flow|Soy Phytoestrogen|55 mg/twice daily oral Novasoy®/Soy Phytoestrogen pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.
10988954|NCT00997893|FG002|Participant Flow|Placebo|0 mg tablet/twice daily oral placebo pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.
10988955|NCT00997893|OG000|Outcome|Estradiol/Medroxyprogesterone Acetate|1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
10988956|NCT00997893|OG001|Outcome|Phytoestrogen|55 mg Novasoy pill b.i.d.
10988957|NCT00997893|OG002|Outcome|Placebo|Placebo pill b.i.d
10988958|NCT00997893|EG000|Reported Event|Estradiol/Medroxyprogesterone Acetate|1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
10988959|NCT00997893|EG001|Reported Event|Phytoestrogen|55 mg Novasoy pill b.i.d.
10988960|NCT00997893|EG002|Reported Event|Placebo|Placebo pill b.i.d
10988961|NCT00997932|BG000|Baseline|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
10988962|NCT00997932|FG000|Participant Flow|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
10988963|NCT00997932|OG000|Outcome|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
10988964|NCT00997932|EG000|Reported Event|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
10988965|NCT00997932|EG001|Reported Event|No IUD Insertion|Women in this group underwent baseline data collection, stated they would like to enroll and receive an IUD between 10 minutes and 48 hours postpartum. These women were not eligible to receive the IUD due to delivery elsewhere, medical complications in peri-partum period.
10988966|NCT00997984|BG000|Baseline|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
10988967|NCT00997984|BG001|Baseline|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
10988968|NCT00997984|BG002|Baseline|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
10988969|NCT00997984|BG003|Baseline|Total|Total of all reporting groups
10988970|NCT00997984|FG000|Participant Flow|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
10988971|NCT00997984|FG001|Participant Flow|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
10988972|NCT00997984|FG002|Participant Flow|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
10988973|NCT00997984|OG000|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
10988974|NCT00997984|OG001|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
10988975|NCT00997984|OG002|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
10988976|NCT00997984|OG003|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
10988977|NCT00997984|EG000|Reported Event|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
10988978|NCT00997984|EG001|Reported Event|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
10988979|NCT00997984|EG002|Reported Event|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
10988980|NCT00997984|EG003|Reported Event|All Active|The combined results of the SPD503 AM and PM groups
10988981|NCT00998010|BG000|Baseline|Experimental|"Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200 centigrays (cGy) daily doses to a total dose of 6000 cGy."
10988982|NCT00998010|FG000|Participant Flow|Experimental|"Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200 centigray (cGy) daily doses to a total dose of 6000 cGy."
10988983|NCT00998010|OG000|Outcome|Experimental|"Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy."
10988984|NCT00998010|EG000|Reported Event|Experimental|"Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy."
10988985|NCT00998023|BG000|Baseline|Mynx VCD|Mynx Vascular Closure Device
10988986|NCT00998023|BG001|Baseline|AngioSeal VCD|AngioSeal Vascular Closure Device
10988987|NCT00998023|BG002|Baseline|Total|Total of all reporting groups
10988988|NCT00998023|FG000|Participant Flow|Mynx VCD|Mynx Vascular Closure Device
10988989|NCT00998023|FG001|Participant Flow|AngioSeal VCD|AngioSeal Vascular Closure Device
10988990|NCT00998023|OG000|Outcome|Mynx VCD|Mynx Vascular Closure Device
10988991|NCT00998023|OG001|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
10988992|NCT00998023|EG000|Reported Event|Mynx VCD|Mynx Vascular Closure Device
10988993|NCT00998023|EG001|Reported Event|AngioSeal VCD|AngioSeal Vascular Closure Device
10988994|NCT00998049|BG000|Baseline|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
10988995|NCT00998049|FG000|Participant Flow|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
10988996|NCT00998049|OG000|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
10988997|NCT00998049|EG000|Reported Event|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
10988998|NCT00998205|BG000|Baseline|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
10988999|NCT00998205|FG000|Participant Flow|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
10989000|NCT00998205|OG000|Outcome|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
10989001|NCT00998205|OG000|Outcome|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
10989002|NCT00998205|EG000|Reported Event|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
10989003|NCT00998296|BG000|Baseline|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989004|NCT00998296|BG001|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989005|NCT00998296|BG002|Baseline|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
11348204|NCT04204200|FG001|Participant Flow|Allocated to Liposomal Vitamin C (n= 22)|Participant intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days.
10989006|NCT00998296|BG003|Baseline|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989007|NCT00998296|BG004|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989008|NCT00998296|BG005|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989009|NCT00998296|BG006|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
11348205|NCT04204200|FG002|Participant Flow|Allocated to Placebo (n= 22)|Participant intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure).
10989010|NCT00998296|BG007|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989011|NCT00998296|BG008|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989012|NCT00998296|BG009|Baseline|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989013|NCT00998296|BG010|Baseline|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989014|NCT00998296|BG011|Baseline|Total|Total of all reporting groups
10989015|NCT00998296|FG000|Participant Flow|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989016|NCT00998296|FG001|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989017|NCT00998296|FG002|Participant Flow|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989018|NCT00998296|FG003|Participant Flow|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989019|NCT00998296|FG004|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989020|NCT00998296|FG005|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989021|NCT00998296|FG006|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989022|NCT00998296|FG007|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989023|NCT00998296|FG008|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989024|NCT00998296|FG009|Participant Flow|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989025|NCT00998296|FG010|Participant Flow|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989026|NCT00998296|OG000|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989027|NCT00998296|OG001|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989028|NCT00998296|OG002|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989029|NCT00998296|OG003|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989030|NCT00998296|OG004|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989031|NCT00998296|OG005|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989032|NCT00998296|OG006|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989033|NCT00998296|OG007|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989034|NCT00998296|OG008|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
11348206|NCT04204200|OG000|Outcome|Allocated to Conventional Vitamin C (n= 22)|Participant intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery).
10989035|NCT00998296|OG009|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989036|NCT00998296|OG010|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989037|NCT00998296|OG000|Outcome|Nintedanib 150 mg +Afatinib 30 mg- Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
10989038|NCT00998296|OG001|Outcome|Nintedanib 150 mg +Afatinib 40 mg- Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989039|NCT00998296|OG001|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
10989040|NCT00998296|OG000|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989041|NCT00998296|OG001|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989042|NCT00998296|EG000|Reported Event|Nintedanib 150 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
10989043|NCT00998296|EG001|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
10989044|NCT00998296|EG002|Reported Event|Nintedanib 200 mg +Afatinib 10 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 10 mg was given continuously once daily (q.d.)
10989045|NCT00998296|EG003|Reported Event|Nintedanib 200 mg +Afatinib 20 mg - Continuosly|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 20 mg was given continuously once daily (q.d.)
10989046|NCT00998296|EG004|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
10989047|NCT00998296|EG005|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
10989048|NCT00998296|EG006|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
10989049|NCT00998296|EG007|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week
10989050|NCT00998296|EG008|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
10989051|NCT00998296|EG009|Reported Event|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
10989052|NCT00998296|EG010|Reported Event|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d) plus film-coated tablet of Afatinib 30 mg (q.d)). This is a part of the expansion phase which follows on the dose-escalation phase."
10989053|NCT00998309|BG000|Baseline|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989054|NCT00998309|FG000|Participant Flow|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989055|NCT00998309|OG000|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989056|NCT00998309|OG000|Outcome|Azithromycin -Male|Male participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989057|NCT00998309|OG001|Outcome|Azithromycin-Female|Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989058|NCT00998309|OG000|Outcome|Azithromycin <65 Years|Participants with <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989059|NCT00998309|OG001|Outcome|Azithromycin->=65 Years|Participants>=65 years who took Azithromycin SR as a single dose of 2 g (potency, as azithromycin) with an empty stomach according to Japanese Package Insert.
10989060|NCT00998309|OG000|Outcome|Azithromycin -Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection (SSTI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989061|NCT00998309|OG001|Outcome|Azithromycin-Sexual Transmitted Infection|Participants with Sexual Transmitted Infection (STI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989062|NCT00998309|OG002|Outcome|Aazithromycin-Dental and Oral Surgery Infection|Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989063|NCT00998309|OG000|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989064|NCT00998309|OG001|Outcome|Azithromycin-moderate Infection|"Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.~, moderate infection, or severe in"
10989065|NCT00998309|OG002|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989066|NCT00998309|OG000|Outcome|Azithromycin -Without Hepatic Dysfunction|Participants without Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989067|NCT00998309|OG001|Outcome|Azithromycin-with Hepatic Dysfunction|Participants with Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989068|NCT00998309|OG000|Outcome|Azithromycin-without Renal Dysfunction|Participants without Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989069|NCT00998309|OG001|Outcome|Azithromycin-with Renal Dysfunction|Participants with Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989070|NCT00998309|OG000|Outcome|Azithromycin-without Past Medical History|Participants without Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989071|NCT00998309|OG001|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989072|NCT00998309|OG000|Outcome|Azithromycin Without Complications|Participants without Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989073|NCT00998309|OG001|Outcome|Azithromycin With Complications|Participants with Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989074|NCT00998309|OG000|Outcome|Azithromycin Without PATH|Participants without Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989075|NCT00998309|OG001|Outcome|Azithromycin With PATH|Participants with Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989076|NCT00998309|OG000|Outcome|Azithromycin Without Comcomittant Drugs|Participants without Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989077|NCT00998309|OG001|Outcome|Azithromycin With Comcomittant Drugs|Participants with Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989078|NCT00998309|OG000|Outcome|Azithromycin -With Non-Drug Therapy|Participants without Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989079|NCT00998309|OG001|Outcome|Azithromycin-with Non-Drug Therapy|Participants with Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989080|NCT00998309|OG000|Outcome|Azithromycin Male|Male participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989081|NCT00998309|OG001|Outcome|Azithromycin Female|Female participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989082|NCT00998309|OG000|Outcome|Azithromycin <65 Years|Participants <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989083|NCT00998309|OG001|Outcome|Azithromycin >=65 Years|Participants >=65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989084|NCT00998309|OG000|Outcome|Azithromycin - Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989085|NCT00998309|OG001|Outcome|Azithromycin - Sexual Transmitted Infection|"Participants with Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infectionwho took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert."
10989086|NCT00998309|OG002|Outcome|Azithromycin-Dental, or Oral Surgery Infection|Participants with Dental, or Oral Surgery Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989087|NCT00998309|OG001|Outcome|Azithromycin-moderate Infection|Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989088|NCT00998309|OG000|Outcome|Azithromycin Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989089|NCT00998309|OG001|Outcome|Azithromycin With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989090|NCT00998309|OG000|Outcome|Azithromycin Without Renal Dysfunction|Participants without Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989091|NCT00998309|OG001|Outcome|Azithromycin- With Renal Dysfunction|Participants with Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989092|NCT00998309|OG000|Outcome|Azithromycin -Without Past Medical History|Participants without Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989093|NCT00998309|OG001|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989094|NCT00998309|OG000|Outcome|Azithromycin -Without Complications|Participants without complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
11223192|NCT02351700|EG001|Reported Event|Standard Treatment Group|"IV placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2 mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.~IV placebo: Compare addition of IV placebo intraoperatively and postoperatively against IV Caldolor (ibuprofen) added intraoperatively and postoperatively."
11223193|NCT02351739|BG000|Baseline|Pembrolizumab|"Arm 1: pembrolizumab monotherapy~pembrolizumab"
11223194|NCT02351739|BG001|Baseline|ACP-196 in Combination With Pembrolizumab|"Arm 2: ACP-196 in combination with pembrolizumab~ACP-196 in combination with pembrolizumab"
11223195|NCT02351739|BG002|Baseline|Total|Total of all reporting groups
11223196|NCT02351739|FG000|Participant Flow|Arm 1: Pembrolizumab Monotherapy|Arm 1: Pembrolizumab 200mg Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
11223197|NCT02351739|FG001|Participant Flow|Arm 2- Acalabrutinib+Pembrolizumab|Arm 2: Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)
11223198|NCT02351739|OG000|Outcome|Pembrolizumab|"Arm 1: pembrolizumab monotherapy~pembrolizumab"
11223199|NCT02351739|OG001|Outcome|ACP-196 in Combination With Pembrolizumab|"Arm 2: ACP-196 in combination with pembrolizumab~ACP-196 in combination with pembrolizumab"
10989095|NCT00998309|OG001|Outcome|Azithromycin-with Complications|Participants with complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989096|NCT00998309|OG000|Outcome|Azithromycin Without PATH|Participants without previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989097|NCT00998309|OG001|Outcome|Azithromycin-with PATH|Participants with previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989098|NCT00998309|OG000|Outcome|Azithromycin Without Comcomittant Drugs|Participants without comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989099|NCT00998309|OG001|Outcome|Azithromycin- With Comcomittant Drugs|Participants with comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989100|NCT00998309|OG000|Outcome|Azithromycin Without Non-drug Therapy|Participants without non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989101|NCT00998309|OG001|Outcome|Azithromycin With Non-drug Therapy|Participants with non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989102|NCT00998309|OG000|Outcome|Azithromycin Without Pregnancy in Female|Female participants without Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989103|NCT00998309|OG001|Outcome|Azithromycin With Pregnancy in Female|Female participants with Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989104|NCT00998309|EG000|Reported Event|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
10989105|NCT00998335|BG000|Baseline|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
11223200|NCT02351739|EG000|Reported Event|Arm 1 - Pembrolizumab Monotherapy|Arm 1: Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)
11223201|NCT02351739|EG001|Reported Event|Arm 2 - Acalabrutinib+Pembrolizumab|Arm 2: Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)
11223202|NCT02351817|BG000|Baseline|Overall Study Population|The investigation is a cross-over investigation therefore baseline data is presented for the overall population
11223203|NCT02351817|FG000|Participant Flow|Baseline - Test A - Test B|"First each subject tests baseline product, then Test A and finally Test B.~Baseline product: the subject's usual product~Test A: A newly developed 1-piece, open ostomy appliance for collecting feces~Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
11223204|NCT02351817|FG001|Participant Flow|Baseline - Test B - Test A|"First each subject tests baseline product, then Test B and finally Test A.~Baseline product: the subject's usual product~Test A: A newly developed 1-piece, open ostomy appliance for collecting feces~Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
11223205|NCT02351817|OG000|Outcome|Test A|How many subjects preferred Test A over own product
11223206|NCT02351817|OG001|Outcome|Test B|How many subjects preferred Test B over own product
11223207|NCT02351817|EG000|Reported Event|Baseline|Adverse events reported by subjects testing Own product
11223208|NCT02351817|EG001|Reported Event|Test A|Adverse events reported by subjects testing Test A
11223209|NCT02351817|EG002|Reported Event|Test B|Adverse events reported by subjects testing Test B
10989106|NCT00998335|BG001|Baseline|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
10989107|NCT00998335|BG002|Baseline|Total|Total of all reporting groups
10989108|NCT00998335|FG000|Participant Flow|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
10989109|NCT00998335|FG001|Participant Flow|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
10989110|NCT00998335|OG000|Outcome|Insulin Detemir x 3 Months (All Pts Had Liver MRS)|Liver fat by MRS measured after 3 months of insulin.
10989111|NCT00998335|OG001|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
10989112|NCT00998335|OG000|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
10989113|NCT00998335|OG000|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
11223210|NCT02351934|BG000|Baseline|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
11223211|NCT02351934|BG001|Baseline|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
11223212|NCT02351934|BG002|Baseline|Total|Total of all reporting groups
10989114|NCT00998335|OG000|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
10989115|NCT00998335|OG001|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
11223213|NCT02351934|FG000|Participant Flow|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
11223214|NCT02351934|FG001|Participant Flow|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
11223215|NCT02351934|OG000|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
11336440|NCT03566680|EG000|Reported Event|Orthokeratology Group|"All subjects will be fit in orthokeratology contact lenses.~Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day."
10989116|NCT00998335|OG000|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir).~Long-acting bedtime insulin detemir (Levemir): This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
10989117|NCT00998335|OG001|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations, insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart (insulin detemir plus aspart) will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated. This group will receive Insulin detemir and pre-meal insulin aspart.~Insulin detemir and pre-meal insulin aspart.: This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner."
10989118|NCT00998335|EG000|Reported Event|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
10989119|NCT00998335|EG001|Reported Event|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
10989120|NCT00998374|BG000|Baseline|Pyloric-sparing|Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch
10989121|NCT00998374|BG001|Baseline|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass
10989122|NCT00998374|BG002|Baseline|Total|Total of all reporting groups
10989123|NCT00998374|FG000|Participant Flow|Pyloric-sparing|Pyloric: Sleeve Gastrectomy (SG) & Duodenal Switch (DS)
10989124|NCT00998374|FG001|Participant Flow|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB)
10989125|NCT00998374|OG000|Outcome|Pyloric-sparing|Pyloric: SG & DS
10989126|NCT00998374|OG001|Outcome|Non-pyloric Sparing|Non-pyloric sparing: RYGB
11336441|NCT03566810|BG000|Baseline|First Test GXR (Fasting), Then Reference GXR (Fasting)|Participants received a single oral dose of 500 milligrams (mg) of test GXR tablet (Merck Nantong, China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GXR (Merck Darmstadt, Germany) on Day 8 in treatment period 2 under fasting conditions. There was a wash-out period of 7 days between each treatment period.
10989127|NCT00998374|OG001|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
10989128|NCT00998374|OG001|Outcome|Non-pyloric|Non-pyloric: RYGB
10989129|NCT00998374|EG000|Reported Event|Pyloric-sparing|Pyloric: SG & DS
10989130|NCT00998374|EG001|Reported Event|Non-pyloric Sparing|Non-pyloric: RYGB
10989131|NCT00998400|BG000|Baseline|CBT/WBT|"Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification (expertimental group)~CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others."
10989132|NCT00998400|BG001|Baseline|Clinical Management|"Clinical management - CM (control group)~Clinical management entails the same amount of time and attention from a professional figure than the experimental group, but specific interventions were proscribed. Such form of active control consisted of empathic listening, reviewing patients' clinical status, distress and worries, and encouragement of treatment adherence."
10989133|NCT00998400|BG002|Baseline|Total|Total of all reporting groups
10989134|NCT00998400|FG000|Participant Flow|CBT/WBT|"Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification~CBT in combination with WBT and life style modification: CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others."
10989135|NCT00998400|FG001|Participant Flow|Clinical Management|"Clinical management - CM (control group)~Clinical management entails the same amount of time and attention from a professional figure than the experimental group, but specific interventions were proscribed. Such form of active control consisted of empathic listening, reviewing patients' clinical status, distress and worries, and encouragement of treatment adherence."
10989136|NCT00998400|OG000|Outcome|CBT/WBT|"Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification (experimental group)~CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others."
10989137|NCT00998400|OG001|Outcome|Clinical Management|"Clinical management - CM (control group)~Clinical management entails the same amount of time and attention from a professional figure than the experimental group, but specific interventions were proscribed. Such form of active control consisted of empathic listening, reviewing patients' clinical status, distress and worries, and encouragement of treatment adherence."
10989138|NCT00998400|OG000|Outcome|CBT/WBT|"Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification~CBT in combination with WBT and life style modification: CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others."
10989139|NCT00998400|EG000|Reported Event|CBT/WBT|"Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification (experimental group)~CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others."
10989140|NCT00998400|EG001|Reported Event|Clinical Management|"Clinical management - CM (control group)~Clinical management entails the same amount of time and attention from a professional figure than the experimental group, but specific interventions were proscribed. Such form of active control consisted of empathic listening, reviewing patients' clinical status, distress and worries, and encouragement of treatment adherence."
10989141|NCT00998426|BG000|Baseline|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. All participants will undergo two finger stick tests, one with a glucose-specific monitoring device(GS-POC) and one with a glucose non-specific monitoring device(GNS-POC) and a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose ). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
10989142|NCT00998426|FG000|Participant Flow|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
10989143|NCT00998426|OG000|Outcome|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device (GS-POC)and one with a glucose non-specific (GNS-POC) monitoring device; a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
10989144|NCT00998426|EG000|Reported Event|Acute Phase|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
10989145|NCT00998426|EG001|Reported Event|Chronic Phase|"Study procedures will occur one time at least three (3) months post liver transplant. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~glucose monitoring before and after HepaGam B administration: Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.~HepaGam B (Hepatitis B Immune Globulin (HBIG)): Subjects will be gi"
10989146|NCT00998517|BG000|Baseline|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
10989147|NCT00998517|BG001|Baseline|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
10989148|NCT00998517|BG002|Baseline|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
10989149|NCT00998517|BG003|Baseline|Total|Total of all reporting groups
10989150|NCT00998517|FG000|Participant Flow|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
11098996|NCT01579162|BG003|Baseline|NASH Patients With F0-F2 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11098997|NCT01579162|BG004|Baseline|NASH Patients With F3-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11098998|NCT01579162|BG005|Baseline|Total|Total of all reporting groups
11098999|NCT01579162|FG000|Participant Flow|Healthy Controls|"Healthy controls will be recruited to have approximately equal numbers of men and women. Controls will be of healthy weight as defined by a BMI 18-25 and without liver disease or risk factors for liver disease.~Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099000|NCT01579162|FG001|Participant Flow|Chronic HCV Patients With F0-F2 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099001|NCT01579162|FG002|Participant Flow|Chronic HCV Patients With F3-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099002|NCT01579162|FG003|Participant Flow|NASH Patients With F0-F2 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099003|NCT01579162|FG004|Participant Flow|NASH Patients With F3-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099004|NCT01579162|OG000|Outcome|Healthy Controls|"Healthy controls will be recruited to have approximately equal numbers of men and women. Controls will be of healthy weight as defined by a BMI 18-25 and without liver disease or risk factors for liver disease.~Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099005|NCT01579162|OG001|Outcome|Chronic HCV Patients With F0-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099006|NCT01579162|OG002|Outcome|NASH Patients With F0-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099007|NCT01579162|OG000|Outcome|All Subjects (Healthy, NASH, and Chronic HCV)|"All subjects recruited for this study - both Healthy and with HCV or NASH~Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
10989151|NCT00998517|FG001|Participant Flow|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
10989152|NCT00998517|FG002|Participant Flow|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
10989153|NCT00998517|OG000|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
10989154|NCT00998517|OG001|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
10989155|NCT00998517|OG002|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
10989156|NCT00998517|EG000|Reported Event|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
10989157|NCT00998517|EG001|Reported Event|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
10989158|NCT00998517|EG002|Reported Event|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
10989159|NCT00998582|BG000|Baseline|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
10989160|NCT00998582|BG001|Baseline|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
10989161|NCT00998582|BG002|Baseline|Total|Total of all reporting groups
10989162|NCT00998582|FG000|Participant Flow|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
10989163|NCT00998582|FG001|Participant Flow|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
10989164|NCT00998582|OG000|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
10989165|NCT00998582|OG001|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
10989166|NCT00998582|EG000|Reported Event|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
10989167|NCT00998582|EG001|Reported Event|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
10989168|NCT00998660|BG000|Baseline|Dystonia Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat dystonia.
10989169|NCT00998660|BG001|Baseline|Essential Tremor Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor.
10989170|NCT00998660|BG002|Baseline|Parkinsons Disease Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease.
10989171|NCT00998660|BG003|Baseline|Total|Total of all reporting groups
10989172|NCT00998660|FG000|Participant Flow|Patients Receiving an Activa RC Implant|Activa RC: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
10989173|NCT00998660|OG000|Outcome|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
10989174|NCT00998660|EG000|Reported Event|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
10989175|NCT00998764|BG000|Baseline|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study Bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
10989176|NCT00998764|BG001|Baseline|Bapineuzumab/Bapineuzumab|Participants received Bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
10989177|NCT00998764|BG002|Baseline|Total|Total of all reporting groups
10989178|NCT00998764|FG000|Participant Flow|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by intravenous (IV) infusion approximately every 13 weeks up to week 195.
10989179|NCT00998764|FG001|Participant Flow|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
10989180|NCT00998764|OG000|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
10989181|NCT00998764|OG001|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapineuzumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
10989182|NCT00998764|OG001|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
10989183|NCT00998764|OG001|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
10989184|NCT00998764|EG000|Reported Event|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
10989185|NCT00998764|EG001|Reported Event|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
11007333|NCT01090414|FG001|Participant Flow|101-07|Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
10989186|NCT00998790|BG000|Baseline|AMS AdVance Sling Group|"European Male subjects >40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.~American Medical Systems (AMS) AdVance™ Male Sling System: The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed."
10989187|NCT00998790|FG000|Participant Flow|AMS AdVance Sling Group|"European Male subjects >40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.~American Medical Systems (AMS) AdVance™ Male Sling System: The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed."
10989188|NCT00998790|OG000|Outcome|AMS AdVance Sling Group|Male subjects >40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
10989189|NCT00998790|EG000|Reported Event|AMS AdVance Sling Group|Male subjects >40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
10989190|NCT00998868|BG000|Baseline|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
10989191|NCT00998868|FG000|Participant Flow|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
10989192|NCT00998868|OG000|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
10989193|NCT00998868|EG000|Reported Event|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
10989194|NCT00998881|BG000|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
10989195|NCT00998881|BG001|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
10989196|NCT00998881|BG002|Baseline|Total|Total of all reporting groups
10989197|NCT00998881|FG000|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
10989198|NCT00998881|FG001|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
10989199|NCT00998881|OG000|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
10989200|NCT00998881|OG001|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
10989201|NCT00998881|EG000|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
10989202|NCT00998881|EG001|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
10989203|NCT00998946|BG000|Baseline|Pralatrexate|"Participants received pralatrexate at an initial dose of 30 mg/m^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m^2 may be reduced to 20 mg/m^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.~Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate."
10989204|NCT00998946|FG000|Participant Flow|Pralatrexate|"Participants received pralatrexate at an initial dose of 30 mg/m^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m^2 may be reduced to 20 mg/m^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.~Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate."
10989205|NCT00998946|OG000|Outcome|Pralatrexate|"Participants received pralatrexate at an initial dose of 30 mg/m^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m^2 may be reduced to 20 mg/m^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.~Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate."
11007334|NCT01090414|FG002|Participant Flow|101-08|Participants with CLL or iNHL (specifically, small lymphocytic lymphoma (SLL)) received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. Note: Only participants from Cohort 1 were eligible to enter this Study 101-99, so Cohort 2 participants are not presented at all in this record.
10989206|NCT00998946|EG000|Reported Event|Pralatrexate|"Participants received pralatrexate at an initial dose of 30 mg/m^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m^2 may be reduced to 20 mg/m^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.~Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate."
11007335|NCT01090414|FG003|Participant Flow|101-10|Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007336|NCT01090414|OG000|Outcome|101-02 (AML)|Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007337|NCT01090414|OG001|Outcome|101-02 (CLL)|Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007338|NCT01090414|OG002|Outcome|101-02 (DLBCL)|Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007339|NCT01090414|OG003|Outcome|101-02 (iNHL)|Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007340|NCT01090414|OG004|Outcome|101-02 (MCL)|Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007341|NCT01090414|OG005|Outcome|101-02 (MM)|Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007342|NCT01090414|OG006|Outcome|101-07 (CLL)|Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007343|NCT01090414|OG007|Outcome|101-07 (iNHL)|Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007344|NCT01090414|OG008|Outcome|101-07 (MCL)|Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007345|NCT01090414|OG009|Outcome|101-08 (CLL or SLL)|Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007346|NCT01090414|OG010|Outcome|101-10 (iNHL)|Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007347|NCT01090414|OG000|Outcome|101-02|Participants with CLL or iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and entered long-term safety extension study 101-99 to receive the same treatment.
11007348|NCT01090414|OG001|Outcome|101-07|Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and entered long-term safety extension study 101-99 to receive the same treatment.
11007349|NCT01090414|OG002|Outcome|101-08|Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and entered long-term safety extension study 101-99 to receive the same treatment.
11007350|NCT01090414|OG003|Outcome|101-10|Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and entered long-term safety extension study 101-99 to receive the same treatment.
11007351|NCT01090414|OG010|Outcome|101-10 (iNHL)|Participants iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11007352|NCT01090414|EG000|Reported Event|101-02|Participants with CLL, iNHL, MCL, DLBCL, AML, or MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered the long-term safety extension study 101-99 to receive the same treatment.
11007353|NCT01090414|EG001|Reported Event|101-07|Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
10989207|NCT00998985|BG000|Baseline|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989208|NCT00998985|BG001|Baseline|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989209|NCT00998985|BG002|Baseline|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989210|NCT00998985|BG003|Baseline|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989211|NCT00998985|BG004|Baseline|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989212|NCT00998985|BG005|Baseline|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989213|NCT00998985|BG006|Baseline|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989214|NCT00998985|BG007|Baseline|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989215|NCT00998985|BG008|Baseline|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
10989216|NCT00998985|BG009|Baseline|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989217|NCT00998985|BG010|Baseline|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989218|NCT00998985|BG011|Baseline|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
10989219|NCT00998985|BG012|Baseline|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
10989220|NCT00998985|BG013|Baseline|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
10989221|NCT00998985|BG014|Baseline|Total|Total of all reporting groups
10989222|NCT00998985|FG000|Participant Flow|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989223|NCT00998985|FG001|Participant Flow|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989224|NCT00998985|FG002|Participant Flow|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989225|NCT00998985|FG003|Participant Flow|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989226|NCT00998985|FG004|Participant Flow|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989227|NCT00998985|FG005|Participant Flow|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989228|NCT00998985|FG006|Participant Flow|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989229|NCT00998985|FG007|Participant Flow|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989230|NCT00998985|FG008|Participant Flow|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
10989231|NCT00998985|FG009|Participant Flow|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989232|NCT00998985|FG010|Participant Flow|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989233|NCT00998985|FG011|Participant Flow|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
10989234|NCT00998985|FG012|Participant Flow|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
10989235|NCT00998985|FG013|Participant Flow|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
10989236|NCT00998985|OG000|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989237|NCT00998985|OG001|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989238|NCT00998985|OG002|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989239|NCT00998985|OG003|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989240|NCT00998985|OG004|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989241|NCT00998985|OG005|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
10989242|NCT00998985|OG006|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
10989243|NCT00998985|OG007|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
10989244|NCT00998985|OG008|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
10989245|NCT00998985|OG000|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989246|NCT00998985|OG001|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989247|NCT00998985|OG002|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989248|NCT00998985|OG003|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989249|NCT00998985|OG004|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989250|NCT00998985|OG008|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
10989251|NCT00998985|OG009|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989252|NCT00998985|OG010|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989253|NCT00998985|OG011|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989254|NCT00998985|OG012|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989255|NCT00998985|OG013|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989256|NCT00998985|OG000|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989257|NCT00998985|OG001|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989258|NCT00998985|OG002|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989259|NCT00998985|OG003|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989260|NCT00998985|OG004|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
11348207|NCT04204200|OG001|Outcome|Allocated to Liposomal Vitamin C (n= 22)|Participant intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days.
10989261|NCT00998985|OG005|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
10989262|NCT00998985|OG006|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989263|NCT00998985|OG007|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989264|NCT00998985|OG008|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989265|NCT00998985|OG009|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989266|NCT00998985|OG010|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989267|NCT00998985|OG011|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
10989268|NCT00998985|OG012|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
10989269|NCT00998985|OG013|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
10989270|NCT00998985|EG000|Reported Event|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
10989271|NCT00998985|EG001|Reported Event|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
10989272|NCT00998985|EG002|Reported Event|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
10989273|NCT00998985|EG003|Reported Event|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
10989274|NCT00998985|EG004|Reported Event|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
10989275|NCT00998985|EG005|Reported Event|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
10989276|NCT00998985|EG006|Reported Event|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
10989277|NCT00998985|EG007|Reported Event|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
10989278|NCT00998985|EG008|Reported Event|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
10989279|NCT00999037|BG000|Baseline|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
10989280|NCT00999037|BG001|Baseline|Placebo|Placebo: 1 inert tablet tid x 12 weeks
10989281|NCT00999037|BG002|Baseline|Total|Total of all reporting groups
10989282|NCT00999037|FG000|Participant Flow|Renvela|Sevelamer Carbonate (Renvela) 800 mg tablets: 1 tablet TID with meals for 12 weeks
10989283|NCT00999037|FG001|Participant Flow|Placebo|Placebo (inert tablets): 1 tablet TID with meals for 12 weeks
10989284|NCT00999037|OG000|Outcome|Renvela|Sevelamer Carbonate (800 mg tablet) PO TID with meals x 12 weeks
10989285|NCT00999037|OG001|Outcome|Placebo|Placebo (1 inert tablet) PO TID with meals x 12 weeks
10989286|NCT00999037|OG000|Outcome|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
10989287|NCT00999037|OG001|Outcome|Placebo|Placebo: 1 inert tablet tid x 12 weeks
10989288|NCT00999037|EG000|Reported Event|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
10989289|NCT00999037|EG001|Reported Event|Placebo|Placebo: 1 inert tablet tid x 12 weeks
10989290|NCT00999102|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Nebivolol followed by Metoprolol or Metoprolol followed by Nebivolol.
10989291|NCT00999102|FG000|Participant Flow|Nebivolol, Followed by Metoprolol|Participants first received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 9-16 in total).
10989292|NCT00999102|FG001|Participant Flow|Metoprolol, Followed by Nebivolol|Participants first received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 9-16 in total)
10989293|NCT00999102|OG000|Outcome|Nebivolol 5 mg for 4 Weeks|31 subjects received Nebivolol 5 mg daily for 4 weeks.
10989294|NCT00999102|OG001|Outcome|Metoprolol 50 mg for 4 Weeks|31 subjects received Metoprolol 50 mg daily for 4 weeks
10989295|NCT00999102|OG002|Outcome|Nebivolol 10 mg for 4 Weeks|31 subjects received Nebivolol 10 mg daily for 4 weeks.
10989296|NCT00999102|OG003|Outcome|Metoprolol 100 mg for 4 Weeks|31 subjects received Metoprolol 100 mg daily for 4 weeks
10989297|NCT00999102|EG000|Reported Event|Nebivolol 5 mg for 4 Weeks|31 subjects received Nebivolol 5 mg daily for 4 weeks.
10989298|NCT00999102|EG001|Reported Event|Metoprolol 50 mg for 4 Weeks|31 subjects received Metoprolol 50 mg daily for 4 weeks
10989299|NCT00999102|EG002|Reported Event|Nebivolol 10 mg for 4 Weeks|31 subjects received Nebivolol 10 mg daily for 4 weeks.
10989300|NCT00999102|EG003|Reported Event|Metoprolol 100 mg for 4 Weeks|31 subjects received Metoprolol 100 mg daily for 4 weeks
10989301|NCT00999141|BG000|Baseline|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
10989302|NCT00999141|FG000|Participant Flow|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
10989303|NCT00999141|OG000|Outcome|Standard of Care (SoC)|
10989304|NCT00999141|OG001|Outcome|FS VH S/D 4 S-apr|
10989305|NCT00999141|OG000|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
10989306|NCT00999141|OG001|Outcome|FS VH S/D 4 S-apr Side - Seroma|
10989307|NCT00999141|OG002|Outcome|Standard of Care (SoC) Side - Hematoma|
10989308|NCT00999141|OG003|Outcome|Standard of Care (SoC) Side - Seroma|
10989309|NCT00999141|OG000|Outcome|FS VH S/D 4 S-apr|Participants With Hematoma/Seroma on FS VH S/D 4 s-apr Side
10989310|NCT00999141|OG001|Outcome|Standard of Care (SoC)|Participants With Hematoma/Seroma on SoC Side
10989311|NCT00999141|OG000|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 S-apr Side|
10989312|NCT00999141|OG001|Outcome|Participants With Hematoma/Seroma on SoC Side|
10989313|NCT00999141|OG002|Outcome|Participants With Hematoma/Seroma on Both Sides|
10989314|NCT00999141|OG003|Outcome|Participants With No Hematoma/Seroma on Either Side|
10989315|NCT00999141|OG000|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
10989316|NCT00999141|OG001|Outcome|Participants With Less Edema on SoC Side|
10989317|NCT00999141|OG002|Outcome|Participants With No Difference in Edema|
10989318|NCT00999141|OG000|Outcome|FS VH S/D 4 S-apr|
10989319|NCT00999141|OG001|Outcome|Standard of Care (SoC)|
10989320|NCT00999141|OG000|Outcome|Participants Preferring FS VH S/D 4 S-apr|
10989321|NCT00999141|OG001|Outcome|Participants Preferring SoC|
10989322|NCT00999141|OG002|Outcome|Participants With No Preference|
10989323|NCT00999141|OG000|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
10989324|NCT00999141|OG001|Outcome|Proportion of Participants Preferring SoC Side|
10989325|NCT00999141|OG000|Outcome|FS VH S/D 4 S-apr Side - Day 1|
10989326|NCT00999141|OG001|Outcome|SoC Side - Day 1|
10989327|NCT00999141|OG002|Outcome|FS VH S/D 4 S-apr Side - Day 3|
10989328|NCT00999141|OG003|Outcome|SoC Side - Day 3|
10989329|NCT00999141|OG004|Outcome|FS VH S/D 4 S-apr Side - Day 7|
10989330|NCT00999141|OG005|Outcome|SoC Side - Day 7|
10989331|NCT00999141|OG006|Outcome|FS VH S/D 4 S-apr Side - Day 14|
10989332|NCT00999141|OG007|Outcome|SoC Side - Day 14|
10989333|NCT00999141|OG000|Outcome|Facelift Participants|
10989334|NCT00999141|OG000|Outcome|Strongly Prefer FS VH S/D 4 S-apr Side|
10989335|NCT00999141|OG001|Outcome|Somewhat Prefer FS VH S/D 4 S-apr Side|
10989336|NCT00999141|OG002|Outcome|No Preference|
10989337|NCT00999141|OG003|Outcome|Somewhat Prefer SoC Side|
10989338|NCT00999141|OG004|Outcome|Strongly Prefer SoC Side|
10989339|NCT00999141|OG000|Outcome|Not at All Satisfied|
10989340|NCT00999141|OG001|Outcome|A Little Satisfied|
10989341|NCT00999141|OG002|Outcome|Somewhat Satisfied|
10989342|NCT00999141|OG003|Outcome|Moderately Satisfied|
10989343|NCT00999141|OG004|Outcome|Very Satisfied|
10989344|NCT00999141|OG000|Outcome|Not Confident|
10989345|NCT00999141|OG001|Outcome|Not Very Confident|
10989346|NCT00999141|OG002|Outcome|Neutral|
10989347|NCT00999141|OG003|Outcome|Somewhat Confident|
10989348|NCT00999141|OG004|Outcome|Confident|
10989349|NCT00999141|OG001|Outcome|SoC Side - Hematoma|
10989350|NCT00999141|OG002|Outcome|FS VH S/D 4 S-apr Side - Seroma|
10989351|NCT00999141|OG003|Outcome|SoC Side - Seroma|
10989352|NCT00999141|OG000|Outcome|Related Non-Facial Adverse Events|
10989353|NCT00999141|OG001|Outcome|Related Facial Adverse Events|
10989354|NCT00999141|EG000|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care (SoC).
10989355|NCT00999141|EG001|Reported Event|Localized to FS VH S/D 4 S-apr Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4 s-apr
10989356|NCT00999141|EG002|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
10989357|NCT00999167|BG000|Baseline|HPN-100|6 mL BID
10989358|NCT00999167|BG001|Baseline|Placebo|6 mL BID
10989359|NCT00999167|BG002|Baseline|Total|Total of all reporting groups
10989360|NCT00999167|FG000|Participant Flow|HPN-100 6 mL and 9 mL|Subjects will undergo a one step dose escalation over 4 weeks. Subjects will initially receive 6 mL HPN-100 BID for 1 week. On Day 7 and following a satisfactory safety assessment of the subject, the dose will be escalated to 9 mL BID for an additional 3 weeks.
10989361|NCT00999167|FG001|Participant Flow|HPN-100 6 mL|Subjects will receive 6 mL BID HPN-100 for 16 weeks (Part B)
10989362|NCT00999167|FG002|Participant Flow|Placebo|Subjects will receive 6 mL BID placebo for 16 weeks (Part B)
10989363|NCT00999167|OG000|Outcome|HPN-100 BID|6 mL or 9 mL BID HPN-100 (Part A)
10989364|NCT00999167|OG000|Outcome|HPN-100|6 mL BID
10989365|NCT00999167|OG001|Outcome|Placebo|6 mL BID
10989366|NCT00999167|OG000|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
10989367|NCT00999167|OG001|Outcome|Placebo|Placebo 6 mL BID (Part B)
10989368|NCT00999167|EG000|Reported Event|Part A: HPN-100|6 mL BID for 7 days followed by 9 mL BID for 21 days, equivalent to approximately 13.2 and 19.8 grams of HPN-100/day, respectively
10989369|NCT00999167|EG001|Reported Event|Part B: HPN-100|6 mL BID, equivalent to approximately 13.2 grams of HPN-100/day
10989370|NCT00999167|EG002|Reported Event|Part B: Placebo|Matching HPN-100 placebo, 6 mL BID
10989371|NCT00999466|BG000|Baseline|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
10989372|NCT00999466|BG001|Baseline|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
10989373|NCT00999466|BG002|Baseline|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
10989374|NCT00999466|BG003|Baseline|Total|Total of all reporting groups
10989375|NCT00999466|FG000|Participant Flow|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
10989376|NCT00999466|FG001|Participant Flow|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
10989377|NCT00999466|FG002|Participant Flow|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
10989378|NCT00999466|OG000|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
10989379|NCT00999466|OG001|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
10989380|NCT00999466|OG002|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
10989381|NCT00999466|EG000|Reported Event|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
10989382|NCT00999466|EG001|Reported Event|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
10989383|NCT00999466|EG002|Reported Event|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
10989384|NCT00999518|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989385|NCT00999518|BG001|Baseline|Tanezumab 1 mg|Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989386|NCT00999518|BG002|Baseline|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989387|NCT00999518|BG003|Baseline|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989388|NCT00999518|BG004|Baseline|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989389|NCT00999518|BG005|Baseline|Total|Total of all reporting groups
10989390|NCT00999518|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989391|NCT00999518|FG001|Participant Flow|Tanezumab 1 mg|Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989392|NCT00999518|FG002|Participant Flow|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989393|NCT00999518|FG003|Participant Flow|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989394|NCT00999518|FG004|Participant Flow|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989395|NCT00999518|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989396|NCT00999518|OG001|Outcome|Tanezumab 1 mg|Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989397|NCT00999518|OG002|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989398|NCT00999518|OG003|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989399|NCT00999518|OG004|Outcome|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989400|NCT00999518|OG000|Outcome|Tanezumab 1 mg|Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989401|NCT00999518|OG001|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989402|NCT00999518|OG002|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989403|NCT00999518|OG003|Outcome|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989404|NCT00999518|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989405|NCT00999518|EG001|Reported Event|Tanezumab 1 mg|Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989406|NCT00999518|EG002|Reported Event|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989407|NCT00999518|EG003|Reported Event|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989408|NCT00999518|EG004|Reported Event|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.
10989409|NCT00999544|BG000|Baseline|Crossover Within Subject|All subjects were exposed to every condition.
10989410|NCT00999544|FG000|Participant Flow|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. During each of 15 separate test sessions, subjects received pretreatment with aprepitant (0, 40 or 200 mg) followed by a single challenge with a oxycodone (15 or 30, intranasal; 20 or 40 mg) or placebo. The fifteen dose conditions were administered in random order and each subject was exposed to each dose combination once.
10989411|NCT00999544|OG000|Outcome|Placebo-Placebo (in and po)|All subjects received exposure to this study condition once.
10989412|NCT00999544|OG001|Outcome|Aprepitant 40 mg - Placebo|All subjects received exposure to this study condition once.
10989413|NCT00999544|OG002|Outcome|Aprepitant 200 mg- Placebo|All subjects received exposure to this study condition once.
10989414|NCT00999544|OG003|Outcome|Placebo- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
10989415|NCT00999544|OG004|Outcome|Placebo- 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
10989416|NCT00999544|OG005|Outcome|Placebo- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
10989417|NCT00999544|OG006|Outcome|Placebo - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
10989418|NCT00999544|OG007|Outcome|Aprepitant 40 mg- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
10989419|NCT00999544|OG008|Outcome|Aprepitant 40 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
10989420|NCT00999544|OG009|Outcome|Aprepitant 40 mg- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
10989421|NCT00999544|OG010|Outcome|Aprepitant 40 mg - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
10989422|NCT00999544|OG011|Outcome|Aprepitant 200 mg - 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
10989423|NCT00999544|OG012|Outcome|Aprepitant 200 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
10989424|NCT00999544|OG013|Outcome|Aprepitant 200 mg- 20 Oxycodone Oral|All subjects received exposure to this study condition once.
10989425|NCT00999544|OG014|Outcome|Aprepitant 200 mg- 40 Oxycodone Oral|All subjects received exposure to this study condition once.
10989426|NCT00999544|OG000|Outcome|Placebo Aprepitant/0 mg Oxycodone IN PO|"Placebo aprepitant/Placebo oxycodone IN/PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989427|NCT00999544|OG001|Outcome|Placebo Aprepitant/ Oxycodone 15 IN 0 PO|"Placebo aprepitant/ oxycodone 15 IN 0 PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 15mg, IN: Oxycodone 15mg, IN"
10989428|NCT00999544|OG002|Outcome|Placebo Aprepitant/ Oxycodone 30 IN 0 PO|"Placebo aprepitant/ oxycodone 30 IN 0 PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 30mg, IN: Oxycodone 30mg, IN"
10989429|NCT00999544|OG003|Outcome|Placebo Aprepitant/ Oxycodone 0 IN 20 PO|"Placebo aprepitant/ oxycodone 0 IN 20 PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 20mg, p.o.: Oxycodone 20mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989430|NCT00999544|OG004|Outcome|Placebo Aprepitant/ Oxycodone 0 IN 40 PO|"Placebo aprepitant/ oxycodone 0 IN 40 PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 40mg, p.o.: Oxycodone 40mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989431|NCT00999544|OG005|Outcome|Aprepitant 40 mg/ Oxycodone 0 IN 0 PO|"Aprepitant 40 mg/ oxycodone 0 IN 0 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989432|NCT00999544|OG006|Outcome|Aprepitant 40 mg/ Oxycodone 0 IN 20 PO|"Aprepitant 40 mg/ oxycodone 0 IN 20 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 20mg, p.o.: Oxycodone 20mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989433|NCT00999544|OG007|Outcome|Aprepitant 40 mg/ Oxycodone 0 IN 40 PO|"Aprepitant 40 mg/ oxycodone 0 IN 40 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 40mg, p.o.: Oxycodone 40mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989434|NCT00999544|OG008|Outcome|Aprepitant 40 mg/ Oxycodone 15 IN 0 PO|"Aprepitant 40 mg/ oxycodone 15 IN 0 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 15mg, IN: Oxycodone 15mg, IN"
10989435|NCT00999544|OG009|Outcome|Aprepitant 40 mg/ Oxycodone 30 IN 0 PO|"Aprepitant 40 mg/ oxycodone 30 IN 0 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 30mg, IN: Oxycodone 30mg, IN"
10989436|NCT00999544|OG010|Outcome|Aprepitant 200 mg/ Oxycodone 0 IN 0 PO|"Aprepitant 200 mg/ oxycodone 0 IN 0 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989437|NCT00999544|OG011|Outcome|Aprepitant 200 mg/ Oxycodone 0 IN 20 PO|"Aprepitant 200 mg/ oxycodone 0 IN 20 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 20mg, p.o.: Oxycodone 20mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989438|NCT00999544|OG012|Outcome|Aprepitant 200 mg/ Oxycodone 0 IN 40 PO|"Aprepitant 200 mg/ oxycodone 0 IN 40 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 40mg, p.o.: Oxycodone 40mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
10989439|NCT00999544|OG013|Outcome|Aprepitant 200 mg/ Oxycodone 15 IN 0 PO|"Aprepitant 200 mg/ oxycodone 15 IN 0 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 15mg, IN: Oxycodone 15mg, IN"
10989440|NCT00999544|OG014|Outcome|Aprepitant 200 mg/ Oxycodone 30 IN 0 PO|"Aprepitant 200 mg/ oxycodone 30 IN 0 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 30mg, IN: Oxycodone 30mg, IN"
10989441|NCT00999544|EG000|Reported Event|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. This was not a parallel group design.
10989442|NCT00999596|BG000|Baseline|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
10989443|NCT00999596|FG000|Participant Flow|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
10989444|NCT00999596|OG000|Outcome|FFDM Mammograms Score = Pass|Mammogram sets from the Philips Digital System with Pass score for Image Quality
10989445|NCT00999596|OG001|Outcome|FFDM Mammograms Score = Fail|Mammogram sets from the Philips Digital System with Fail score for Image Quality
10989446|NCT00999596|EG000|Reported Event|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
10989447|NCT00999661|BG000|Baseline|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
10989448|NCT00999661|FG000|Participant Flow|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
10989449|NCT00999661|OG000|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
10989450|NCT00999661|EG000|Reported Event|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
10989451|NCT00999687|BG000|Baseline|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks.
10989452|NCT00999687|FG000|Participant Flow|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract (INOE) was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and INOE was applied to both hands twice daily for another 12 weeks.
10989453|NCT00999687|OG000|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
10989454|NCT00999687|OG001|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then change to Indigo Naturalis Oil Extract (INOE) from week 13 to week 24.
10989455|NCT00999687|OG001|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then transfer to Indigo Naturalis Oil Extract from week 13 to week 24
10989456|NCT00999687|EG000|Reported Event|All Participants (Indigo Naturalis Oil Extreact/Olive Oil)|"Experimental group: randomized to receive Indigo Naturalis Oil Extract first; Control group: randomized to receive Olive Oil first.~In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks."
10989457|NCT00999713|BG000|Baseline|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
10989458|NCT00999713|BG001|Baseline|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
10989459|NCT00999713|BG002|Baseline|Total|Total of all reporting groups
10989460|NCT00999713|FG000|Participant Flow|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
10989461|NCT00999713|FG001|Participant Flow|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
10989462|NCT00999713|OG000|Outcome|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
10989463|NCT00999713|OG001|Outcome|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
10989464|NCT00999713|EG000|Reported Event|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
10989465|NCT00999713|EG001|Reported Event|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
10989466|NCT00999830|BG000|Baseline|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
10989467|NCT00999830|BG001|Baseline|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
10989468|NCT00999830|BG002|Baseline|Total|Total of all reporting groups
10989469|NCT00999830|FG000|Participant Flow|Arm A: IPH2101 0.2mg/Kg|IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
10989470|NCT00999830|FG001|Participant Flow|Arm B: IPH2101 2mg/kg|IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
10989471|NCT00999830|OG000|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
10989472|NCT00999830|OG001|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
10989473|NCT00999830|EG000|Reported Event|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
10989474|NCT00999830|EG001|Reported Event|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
10989475|NCT00999908|BG000|Baseline|Entire Study Population|The entire study population includes the 3 groups of patients who received indacaterol 150 μg, tiotropium 18 μg, and placebo (matching indacaterol) once each in 1 of 3 different orders in this crossover study. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10989476|NCT00999908|FG000|Participant Flow|Indacaterol 150 μg-tiotropium 18 μg-placebo|Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10989477|NCT00999908|FG001|Participant Flow|Tiotropium 18 μg-placebo-indacaterol 150 μg|Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10875736|NCT00439309|FG001|Participant Flow|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
10875737|NCT00439309|OG000|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
10875738|NCT00439309|OG001|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
10875739|NCT00439309|EG000|Reported Event|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
10875740|NCT00439309|EG001|Reported Event|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
10875741|NCT00439335|BG000|Baseline|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
10875742|NCT00439335|BG001|Baseline|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
10875743|NCT00439335|BG002|Baseline|Total|Total of all reporting groups
10875744|NCT00439335|FG000|Participant Flow|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
10875745|NCT00439335|FG001|Participant Flow|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
10875746|NCT00439335|OG000|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
10875747|NCT00439335|OG001|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
10875748|NCT00439335|EG000|Reported Event|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
10875749|NCT00439335|EG001|Reported Event|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
10875750|NCT00439374|BG000|Baseline|17 Alpha-hydroxyprogesterone Caproate|"17 alpha-hydroxyprogesterone caproate~17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first."
10875751|NCT00439374|BG001|Baseline|Placebo|castor oil
10875752|NCT00439374|BG002|Baseline|Total|Total of all reporting groups
10875753|NCT00439374|FG000|Participant Flow|17 Alpha-hydroxyprogesterone Caproate|"17 alpha-hydroxyprogesterone caproate~17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first."
10875754|NCT00439374|FG001|Participant Flow|Placebo|castor oil
10875755|NCT00439374|OG000|Outcome|17 Alpha-hydroxyprogesterone Caproate|"17 alpha-hydroxyprogesterone caproate~17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first."
10875756|NCT00439374|OG001|Outcome|Placebo|castor oil
10875757|NCT00439374|EG000|Reported Event|17 Alpha-hydroxyprogesterone Caproate|"250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery~17 alpha-hydroxyprogesterone caproate: Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first."
10875758|NCT00439374|EG001|Reported Event|Placebo|"Placebo oil given by weekly injection until 37 weeks gestation or delivery.~Placebo Oil: Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative"
10875759|NCT00439413|BG000|Baseline|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
10875760|NCT00439413|BG001|Baseline|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
10875761|NCT00439413|BG002|Baseline|Total|Total of all reporting groups
10875762|NCT00439413|FG000|Participant Flow|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
10875763|NCT00439413|FG001|Participant Flow|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
10875764|NCT00439413|OG000|Outcome|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
10875765|NCT00439413|OG001|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
10875766|NCT00439413|OG000|Outcome|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
10875767|NCT00439413|OG001|Outcome|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
10875768|NCT00439413|EG000|Reported Event|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
10875769|NCT00439413|EG001|Reported Event|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
10875770|NCT00439465|BG000|Baseline|Ex-vivo Expanded Effector Cells|"Infusing IL-2 and GM-CSF post-HCST~Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes."
10875771|NCT00439465|FG000|Participant Flow|Ex-vivo Expanded Effector Cells|"Infusing Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (GM-CSF)post-Hematopoietic stem cell transplant (HSCT)~Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes."
10875772|NCT00439465|OG000|Outcome|Ex-vivo Expanded Effector Cells|Infusing IL-2 and GM-CSF post-Hematopoietic Stem-Cell Transplant (HSCT) Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
11348208|NCT04204200|OG002|Outcome|Allocated to Placebo (n= 22)|Participant intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure).
10875773|NCT00439465|OG000|Outcome|Ex-vivo Expanded Effector Cells|"Infusing IL-2 and GM-CSF post-HCST~Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes."
10875774|NCT00439465|OG000|Outcome|Ex-vivo Expanded Effector Cells|"Infusing IL-2 and GM-CSF post-Hematopoietic Stem Cell Transplant (HSCT)~Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes."
10875775|NCT00439465|OG000|Outcome|Ex-vivo Expanded Effector Cells|"Infusing Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (GM-CSF)post-Hematopoietic stem cell transplant (HSCT)~Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes."
10875776|NCT00439465|EG000|Reported Event|Ex-vivo Expanded Effector Cells|"Infusing IL-2 and GM-CSF post-HCST~Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes."
10875777|NCT00439517|BG000|Baseline|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
10875778|NCT00439517|BG001|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
10875779|NCT00439517|BG002|Baseline|Total|Total of all reporting groups
11099008|NCT01579162|OG000|Outcome|Nash + Chronic HCV Patients With F0-F2 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099009|NCT01579162|OG001|Outcome|NASH + Chronic HCV Patients With F3-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099010|NCT01579162|EG000|Reported Event|Healthy Controls|"Healthy controls will be recruited to have approximately equal numbers of men and women. Controls will be of healthy weight as defined by a BMI 18-25 and without liver disease or risk factors for liver disease.~Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099011|NCT01579162|EG001|Reported Event|Chronic HCV Patients With F0-F2 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099012|NCT01579162|EG002|Reported Event|Chronic HCV Patients With F3-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
10875780|NCT00439517|FG000|Participant Flow|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
10875781|NCT00439517|FG001|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
10875782|NCT00439517|OG000|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
10875783|NCT00439517|OG001|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
10875784|NCT00439517|EG000|Reported Event|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
10875785|NCT00439517|EG001|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
10875786|NCT00439556|BG000|Baseline|Velcade Dose Level 1|BEAM + Rituxan + ATG(MUD pts only) + Velcade (1-1.3mg/m2) + ALLO SCT
10875787|NCT00439556|BG001|Baseline|Velcade Dose Level 2|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT
10875788|NCT00439556|BG002|Baseline|Velcade Dose Level 3|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT
10875789|NCT00439556|BG003|Baseline|Total|Total of all reporting groups
10875790|NCT00439556|FG000|Participant Flow|Velcade Dose Level 1|BEAM (Carmustine/Etoposide/Cytarabine/Melphalan) + Rituxan + ATG (Thymoglobulin) (MUD pts only) + Velcade 1.0mg/m2 + ALLO SCT
10875791|NCT00439556|FG001|Participant Flow|Velcade Dose Level 2|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT
10875792|NCT00439556|FG002|Participant Flow|Velcade Dose Level 3|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT
10875793|NCT00439556|OG000|Outcome|Treatment (Chemotherapy, Transplant, Filgrastim, Tacrolimus)|BEAM + Rituxan + ATG(MUD pts only) + Velcade (1-1.3mg/m2) + ALLO SCT
10875794|NCT00439556|OG001|Outcome|Velcade Dose Level 2|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT
10989478|NCT00999908|FG002|Participant Flow|Placebo-indacaterol 150 μg-tiotropium 18 μg|Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10875795|NCT00439556|OG002|Outcome|Velcade Dose Level 3|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT
10875796|NCT00439556|OG000|Outcome|Velcade Dose Level 1|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.0mg/m2 + ALLO SCT
10875797|NCT00439556|EG000|Reported Event|Velcade Dose Level 1|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.0mg/m2 + ALLO SCT
10875798|NCT00439556|EG001|Reported Event|Velcade Dose Level 2|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT
10875799|NCT00439556|EG002|Reported Event|Gemcitabine Dose Level 3|BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT
10875800|NCT00439608|BG000|Baseline|Treatment|Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
10875801|NCT00439608|FG000|Participant Flow|Treatment|"Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer~Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first. Patients were then monitored for 1 h. Paclitaxel was then administered followed by carboplatin. Radiation was generally administered after chemotherapy. Dexamethasone 20 mg intravenously (IV), diphenhydramine 50 mg IV, and ranitidine 50 mg IV were given 30 min before treatment. Dosages of dexamethasone and diphenhydramine could be reduced in subsequent weeks if no hypersensitivity reactions were observed."
10875802|NCT00439608|OG000|Outcome|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
10875803|NCT00439608|EG000|Reported Event|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
10875804|NCT00439647|BG000|Baseline|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
10875805|NCT00439647|BG001|Baseline|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
10875806|NCT00439647|BG002|Baseline|Total|Total of all reporting groups
10875807|NCT00439647|FG000|Participant Flow|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
10875808|NCT00439647|FG001|Participant Flow|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
10875809|NCT00439647|OG000|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
10875810|NCT00439647|OG001|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
10875811|NCT00439647|EG000|Reported Event|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
10875812|NCT00439647|EG001|Reported Event|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
10875813|NCT00439673|BG000|Baseline|Study Group|
10875814|NCT00439673|FG000|Participant Flow|Study Group|
10875815|NCT00439673|OG000|Outcome|Study Group|
10875816|NCT00439673|EG000|Reported Event|Study Group|Other adverse events were not included in the final study report, thus, we have included in the present form, all serious adverse events and mortality.
10875817|NCT00439725|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
10875818|NCT00439725|BG001|Baseline|Placebo|Participants were to receive matching placebo oral tablet once daily
10875819|NCT00439725|BG002|Baseline|Total|Total of all reporting groups
10875820|NCT00439725|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
10875821|NCT00439725|FG001|Participant Flow|Placebo|Participants were to receive matching placebo oral tablet once daily
10875822|NCT00439725|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
10875823|NCT00439725|OG001|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
10875824|NCT00439725|EG000|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
10875825|NCT00439725|EG001|Reported Event|Placebo|Participants were to receive matching placebo oral tablet once daily
10989479|NCT00999908|OG000|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10989480|NCT00999908|OG001|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10989481|NCT00999908|OG002|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10989482|NCT00999908|EG000|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10989483|NCT00999908|EG001|Reported Event|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10989484|NCT00999908|EG002|Reported Event|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10989485|NCT00999921|BG000|Baseline|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily ffrom 5th day to 25 th day of menstrual cycle for 3 months
10989486|NCT00999921|BG001|Baseline|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months
10989487|NCT00999921|BG002|Baseline|Total|Total of all reporting groups
10989488|NCT00999921|FG000|Participant Flow|Tamoxifen|Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months
10989489|NCT00999921|FG001|Participant Flow|Evening Primrose Oil|Evening Primrose Oil 1000 mg daily for 3 months
10989490|NCT00999921|OG000|Outcome|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
10989491|NCT00999921|OG001|Outcome|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
10989492|NCT00999921|OG000|Outcome|Tamoxifen|Tamoxifen administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
10989493|NCT00999921|OG001|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
10989494|NCT00999921|OG000|Outcome|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
10989495|NCT00999921|EG000|Reported Event|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
10989496|NCT00999921|EG001|Reported Event|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
10989497|NCT01000025|BG000|Baseline|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
10989498|NCT01000025|BG001|Baseline|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
10989499|NCT01000025|BG002|Baseline|Total|Total of all reporting groups
10989500|NCT01000025|FG000|Participant Flow|PF-804|Study treatment arm
10989501|NCT01000025|FG001|Participant Flow|Placebo|Control arm
10989502|NCT01000025|OG000|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
10989503|NCT01000025|OG001|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
10989504|NCT01000025|EG000|Reported Event|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
10989505|NCT01000025|EG001|Reported Event|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
10989506|NCT01000051|BG000|Baseline|Eltrombopag|"Starting dose 50 mg/day orally for 8 weeks~Eltrombopag: Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily."
10989507|NCT01000051|BG001|Baseline|Placebo|"Once a day orally for 8 weeks~Placebo: Once a day, orally for 8 weeks."
10989508|NCT01000051|BG002|Baseline|Total|Total of all reporting groups
10989509|NCT01000051|FG000|Participant Flow|Eltrombopag|"Starting dose 50 mg/day orally for 8 weeks~Eltrombopag: Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily."
10989510|NCT01000051|FG001|Participant Flow|Placebo|"Once a day orally for 8 weeks~Placebo: Once a day, orally for 8 weeks."
10989511|NCT01000051|OG000|Outcome|Eltrombopag|"Starting dose 50 mg/day orally for 8 weeks~Eltrombopag: Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily."
10989512|NCT01000051|OG001|Outcome|Placebo|"Once a day orally for 8 weeks~Placebo: Once a day, orally for 8 weeks."
10989513|NCT01000051|EG000|Reported Event|Eltrombopag|"Starting dose 50 mg/day orally for 8 weeks~Eltrombopag: Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily."
10989514|NCT01000051|EG001|Reported Event|Placebo|"Once a day orally for 8 weeks~Placebo: Once a day, orally for 8 weeks."
10989515|NCT01000064|BG000|Baseline|All Participants|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
10989516|NCT01000064|FG000|Participant Flow|Vyvanse First, Then Placebo|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
10989517|NCT01000064|FG001|Participant Flow|Placebo First, Then Vyvanse|"Drug: Placebo Capsules taken for 42 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days."
10989518|NCT01000064|OG000|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
10989519|NCT01000064|OG001|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
10989520|NCT01000064|OG000|Outcome|All Participants|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
10989521|NCT01000064|OG000|Outcome|Vyvanse First, Then Placebo|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
10989522|NCT01000064|OG001|Outcome|Placebo First, Then Vyvanse|"Drug: Placebo Capsules taken for 42 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days."
10989523|NCT01000064|EG000|Reported Event|Vyvanse|Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
10989524|NCT01000064|EG001|Reported Event|Placebo|Placebo capsule Taken for 42 days.
10989525|NCT01000155|BG000|Baseline|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
10989526|NCT01000155|FG000|Participant Flow|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
10989527|NCT01000155|OG000|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
10989528|NCT01000155|EG000|Reported Event|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
10989529|NCT01000285|BG000|Baseline|Acute ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
10989530|NCT01000285|BG001|Baseline|Lymphoma ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
10989531|NCT01000285|BG002|Baseline|Total|Total of all reporting groups
10989532|NCT01000285|FG000|Participant Flow|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
10989533|NCT01000285|OG000|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
10989534|NCT01000285|OG000|Outcome|Responders|Patients who had a complete or partial response to treatment
10989535|NCT01000285|OG001|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
10989536|NCT01000285|OG000|Outcome|Patient A (Responder) Pre-Therapy|
10989537|NCT01000285|OG001|Outcome|Patient A (Responder) Post-Therapy|
10989538|NCT01000285|OG002|Outcome|Patient B (Responder) Pre-Therapy|
10989539|NCT01000285|OG003|Outcome|Patient B (Responder) Post-Therapy|
10989540|NCT01000285|OG004|Outcome|Patient C (Non-responder) Pre-Therapy|
10989541|NCT01000285|OG005|Outcome|Patient C (Non-responder) Post-Therapy|
10989542|NCT01000285|OG006|Outcome|Patient D (Non-responder) Pre-Therapy|
10989543|NCT01000285|OG007|Outcome|Patient D (Non-responder) Post-Therapy|
10989544|NCT01000285|EG000|Reported Event|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
10989545|NCT01000311|BG000|Baseline|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
10989546|NCT01000311|BG001|Baseline|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
10989547|NCT01000311|BG002|Baseline|Total|Total of all reporting groups
10989548|NCT01000311|FG000|Participant Flow|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
10989549|NCT01000311|FG001|Participant Flow|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
10989550|NCT01000311|OG000|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
10989551|NCT01000311|OG001|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
10989552|NCT01000311|EG000|Reported Event|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
10989553|NCT01000311|EG001|Reported Event|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
10989554|NCT01000324|BG000|Baseline|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
10989555|NCT01000324|FG000|Participant Flow|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
10989556|NCT01000324|OG000|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
10989557|NCT01000324|OG000|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
10989558|NCT01000324|EG000|Reported Event|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
10875826|NCT00439777|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
10875827|NCT00439777|BG001|Baseline|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
10875828|NCT00439777|BG002|Baseline|Total|Total of all reporting groups
10875829|NCT00439777|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
10875830|NCT00439777|FG001|Participant Flow|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
10875831|NCT00439777|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
10875832|NCT00439777|OG001|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
10875833|NCT00439777|EG000|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
10875834|NCT00439777|EG001|Reported Event|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
10875835|NCT00439946|BG000|Baseline|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
10875836|NCT00439946|FG000|Participant Flow|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil initiated to deliver a dose 20% higher than the epoprostenol dose on a ng/kg/min basis. IV treprostinil dosing was titrated without restriction during the eight week follow-up period per the investigator's judgment to optimize the dose for symptomatic benefit based on clinical signs / symptoms, exercise capacity and tolerability.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
10875837|NCT00439946|OG000|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
10875838|NCT00439946|EG000|Reported Event|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
10875839|NCT00440011|BG000|Baseline|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
10875840|NCT00440011|BG001|Baseline|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
10875841|NCT00440011|BG002|Baseline|Total|Total of all reporting groups
10875842|NCT00440011|FG000|Participant Flow|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
10875843|NCT00440011|FG001|Participant Flow|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
10875844|NCT00440011|OG000|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
10875845|NCT00440011|OG001|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
10875846|NCT00440011|EG000|Reported Event|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
10875847|NCT00440011|EG001|Reported Event|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
10875848|NCT00440037|BG000|Baseline|AMG 531|AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
10875849|NCT00440037|FG000|Participant Flow|AMG 531|AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
10875850|NCT00440037|OG000|Outcome|AMG 531|AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
10875851|NCT00440037|EG000|Reported Event|AMG 531|AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
10875852|NCT00440050|BG000|Baseline|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
10875853|NCT00440050|BG001|Baseline|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
10875854|NCT00440050|BG002|Baseline|Total|Total of all reporting groups
10875855|NCT00440050|FG000|Participant Flow|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
10875856|NCT00440050|FG001|Participant Flow|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
10875857|NCT00440050|OG000|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
10875858|NCT00440050|OG001|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
10875859|NCT00440050|EG000|Reported Event|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
10875860|NCT00440050|EG001|Reported Event|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
10875861|NCT00440115|BG000|Baseline|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
10875862|NCT00440115|BG001|Baseline|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
10875863|NCT00440115|BG002|Baseline|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
10875864|NCT00440115|BG003|Baseline|Total|Total of all reporting groups
10875865|NCT00440115|FG000|Participant Flow|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
10875866|NCT00440115|FG001|Participant Flow|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
10875867|NCT00440115|FG002|Participant Flow|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
11336442|NCT03566810|BG001|Baseline|First Reference GXR (Fasting), Then Test GXR (Fasting)|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt, Germany) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GXR (Merck Nantong, China) on Day 8 in treatment period 2 under fasting conditions. There was a wash-out period of 7 days between each treatment period.
10875868|NCT00440115|OG000|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
10875869|NCT00440115|OG001|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
10875870|NCT00440115|OG002|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
10875871|NCT00440115|EG000|Reported Event|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
10875872|NCT00440115|EG001|Reported Event|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
10875873|NCT00440115|EG002|Reported Event|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
10875874|NCT00440180|BG000|Baseline|Placebo|Placebo once daily
10875875|NCT00440180|BG001|Baseline|Anastrozole|1 milligram daily
10875876|NCT00440180|BG002|Baseline|Total|Total of all reporting groups
10875877|NCT00440180|FG000|Participant Flow|Placebo|Placebo once daily
10875878|NCT00440180|FG001|Participant Flow|Anastrozole|1 milligram daily
10875879|NCT00440180|OG000|Outcome|Placebo|Placebo once daily
10875880|NCT00440180|OG001|Outcome|Anastrozole|1 milligram daily
10875881|NCT00440180|EG000|Reported Event|Placebo|Placebo once daily
10875882|NCT00440180|EG001|Reported Event|Anastrozole|1 milligram daily
10875883|NCT00440193|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
10875884|NCT00440193|BG001|Baseline|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
10875885|NCT00440193|BG002|Baseline|Total|Total of all reporting groups
10875886|NCT00440193|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
10875887|NCT00440193|FG001|Participant Flow|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
10875888|NCT00440193|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
10875889|NCT00440193|OG001|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
10875890|NCT00440193|EG000|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
10875891|NCT00440193|EG001|Reported Event|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
10875892|NCT00440232|BG000|Baseline|Frovatriptan|5.0 mg of Frovatriptan given as single dose
10875893|NCT00440232|BG001|Baseline|Placebo|
10875894|NCT00440232|BG002|Baseline|Total|Total of all reporting groups
10875895|NCT00440232|FG000|Participant Flow|Frovatriptan|5.0 mg of Frovatriptan given as single dose
10875896|NCT00440232|FG001|Participant Flow|Placebo|
10875897|NCT00440232|OG000|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
10875898|NCT00440232|OG001|Outcome|Placebo|
10875899|NCT00440232|EG000|Reported Event|Frovatriptan|5.0 mg of Frovatriptan given as single dose
10875900|NCT00440232|EG001|Reported Event|Placebo|
10875901|NCT00440297|BG000|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
10875902|NCT00440297|BG001|Baseline|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
10875903|NCT00440297|BG002|Baseline|Total|Total of all reporting groups
10875904|NCT00440297|FG000|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
10875905|NCT00440297|FG001|Participant Flow|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
10875906|NCT00440297|OG000|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
10875907|NCT00440297|OG001|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
10875908|NCT00440297|EG000|Reported Event|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
10875909|NCT00440297|EG001|Reported Event|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
10875910|NCT00440310|BG000|Baseline|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
10875911|NCT00440310|BG001|Baseline|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
10875912|NCT00440310|BG002|Baseline|Total|Total of all reporting groups
10875913|NCT00440310|FG000|Participant Flow|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
10875914|NCT00440310|FG001|Participant Flow|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
10875915|NCT00440310|OG000|Outcome|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
10875916|NCT00440310|OG001|Outcome|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
10875917|NCT00440310|EG000|Reported Event|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
10875918|NCT00440310|EG001|Reported Event|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
10875919|NCT00440401|BG000|Baseline|TachoSil®|
10875920|NCT00440401|BG001|Baseline|Standard Treatment|
10875921|NCT00440401|BG002|Baseline|Total|Total of all reporting groups
10875922|NCT00440401|FG000|Participant Flow|TachoSil®|Absorbable sponge for intra-operative topical application
10875923|NCT00440401|FG001|Participant Flow|Comparator|Standard haemostatic treatment in cardiovascular surgery
10875924|NCT00440401|OG000|Outcome|TachoSil®|
10875925|NCT00440401|OG001|Outcome|Standard Treatment|
10875926|NCT00440401|EG000|Reported Event|TachoSil®|
10875927|NCT00440401|EG001|Reported Event|Standard Treatment|
10875928|NCT00440466|BG000|Baseline|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
10875929|NCT00440466|BG001|Baseline|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
10875930|NCT00440466|BG002|Baseline|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
10875931|NCT00440466|BG003|Baseline|Total|Total of all reporting groups
10875932|NCT00440466|FG000|Participant Flow|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
10875933|NCT00440466|FG001|Participant Flow|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
10875934|NCT00440466|FG002|Participant Flow|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
10875935|NCT00440466|OG000|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
10875936|NCT00440466|OG001|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
10875937|NCT00440466|OG002|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
10875938|NCT00440466|EG000|Reported Event|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
10875939|NCT00440466|EG001|Reported Event|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
10875940|NCT00440466|EG002|Reported Event|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
10875941|NCT00440505|BG000|Baseline|Entire Study Population|
10875942|NCT00440505|FG000|Participant Flow|Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg|Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
10875943|NCT00440505|FG001|Participant Flow|Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg|Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
10875944|NCT00440505|FG002|Participant Flow|Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo|Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
10875945|NCT00440505|FG003|Participant Flow|Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg|Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
10875946|NCT00440505|FG004|Participant Flow|Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo|Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
10875947|NCT00440505|FG005|Participant Flow|Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg|Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
10875948|NCT00440505|OG000|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
10875949|NCT00440505|OG001|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
10875950|NCT00440505|OG002|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
10875951|NCT00440505|EG000|Reported Event|Placebo|Non-smokers with the placebo patch
10875952|NCT00440505|EG001|Reported Event|Nicotine 5mg|Non-smokers with the Nicotine 5mg patch
10875953|NCT00440505|EG002|Reported Event|Nicotine 10mg|Non-smokers with the Nicotine 10mg patch
10875954|NCT00440518|BG000|Baseline|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875955|NCT00440518|BG001|Baseline|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875956|NCT00440518|BG002|Baseline|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875957|NCT00440518|BG003|Baseline|Total|Total of all reporting groups
10875958|NCT00440518|FG000|Participant Flow|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875959|NCT00440518|FG001|Participant Flow|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875960|NCT00440518|FG002|Participant Flow|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875961|NCT00440518|OG000|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875962|NCT00440518|OG001|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875963|NCT00440518|OG002|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875964|NCT00440518|EG000|Reported Event|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875965|NCT00440518|EG001|Reported Event|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875966|NCT00440518|EG002|Reported Event|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
10875967|NCT00440557|BG000|Baseline|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
10875968|NCT00440557|BG001|Baseline|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
10875969|NCT00440557|BG002|Baseline|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
10875970|NCT00440557|BG003|Baseline|Total|Total of all reporting groups
10875971|NCT00440557|FG000|Participant Flow|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
10875972|NCT00440557|FG001|Participant Flow|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
10875973|NCT00440557|FG002|Participant Flow|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
10875974|NCT00440557|OG000|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
10875975|NCT00440557|OG001|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
10875976|NCT00440557|OG002|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
10875977|NCT00440557|EG000|Reported Event|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
10875978|NCT00440557|EG001|Reported Event|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
10875979|NCT00440557|EG002|Reported Event|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
10875980|NCT00440596|BG000|Baseline|MBSR|Mindfulness based stress reduction
10875981|NCT00440596|BG001|Baseline|Progressive Muscle Relaxation|Progressive Muscle Relaxation 8 weeks group treatment
10875982|NCT00440596|BG002|Baseline|Total|Total of all reporting groups
10875983|NCT00440596|FG000|Participant Flow|MBSR|Mindfulness based stress reduction
10875984|NCT00440596|FG001|Participant Flow|Progressive Muscle Relaxation|Progressive Muscle Relaxation 8 weeks group treatment
10875985|NCT00440596|OG000|Outcome|MBSR|
10875986|NCT00440596|OG001|Outcome|Progressive Muscle Relaxation|
10875987|NCT00440596|OG000|Outcome|MBSR|Mindfulness based stress reduction
10875988|NCT00440596|OG001|Outcome|Progressive Muscle Relaxation|Progressive Muscle Relaxation 8 weeks group treatment
10875989|NCT00440596|EG000|Reported Event|MBSR|Mindfulness based stress reduction
10875990|NCT00440596|EG001|Reported Event|Progressive Muscle Relaxation|Progressive Muscle Relaxation 8 weeks group treatment
10875991|NCT00440700|BG000|Baseline|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
10875992|NCT00440700|BG001|Baseline|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
10989559|NCT01000337|BG000|Baseline|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
10989560|NCT01000337|BG001|Baseline|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
10989561|NCT01000337|BG002|Baseline|Total|Total of all reporting groups
10989562|NCT01000337|FG000|Participant Flow|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
10989563|NCT01000337|FG001|Participant Flow|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
10989564|NCT01000337|OG000|Outcome|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
10989565|NCT01000337|OG001|Outcome|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
10989566|NCT01000337|EG000|Reported Event|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
10989567|NCT01000337|EG001|Reported Event|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
10989568|NCT01000376|BG000|Baseline|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
10989569|NCT01000376|BG001|Baseline|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
10989570|NCT01000376|BG002|Baseline|Total|Total of all reporting groups
10989571|NCT01000376|FG000|Participant Flow|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
10989572|NCT01000376|FG001|Participant Flow|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
10989573|NCT01000376|OG000|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
10989574|NCT01000376|OG001|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
10989575|NCT01000376|EG000|Reported Event|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
10989576|NCT01000376|EG001|Reported Event|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
10989577|NCT01000480|BG000|Baseline|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
10989578|NCT01000480|FG000|Participant Flow|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
10989579|NCT01000480|OG000|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
10989580|NCT01000480|EG000|Reported Event|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
10989581|NCT01000493|BG000|Baseline|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
10989582|NCT01000493|BG001|Baseline|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
10989583|NCT01000493|BG002|Baseline|Total|Total of all reporting groups
10989584|NCT01000493|FG000|Participant Flow|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
10989585|NCT01000493|FG001|Participant Flow|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
10989586|NCT01000493|OG000|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
10989587|NCT01000493|OG001|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
10989588|NCT01000493|EG000|Reported Event|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
10989589|NCT01000493|EG001|Reported Event|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
10989590|NCT01000506|BG000|Baseline|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989591|NCT01000506|BG001|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989592|NCT01000506|BG002|Baseline|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10875993|NCT00440700|BG002|Baseline|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
10875994|NCT00440700|BG003|Baseline|Total|Total of all reporting groups
10875995|NCT00440700|FG000|Participant Flow|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
10875996|NCT00440700|FG001|Participant Flow|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
10875997|NCT00440700|FG002|Participant Flow|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
10875998|NCT00440700|OG000|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
10875999|NCT00440700|OG001|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
10876000|NCT00440700|OG002|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
10876001|NCT00440700|EG000|Reported Event|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
10876002|NCT00440700|EG001|Reported Event|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
10876003|NCT00440700|EG002|Reported Event|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
10876004|NCT00440726|BG000|Baseline|Phase 1 Dose Level 1|"Bortezomib (Velcade): Intravenous on days 1, 4, 8 and 11, dose-escalation~Dexamethasone: Intravenous or oral administration for 14 days.~PEG-asparaginase: Intramuscular injection~Doxorubicin: Intravenous infusion~Cytarabine: Intrathecal administration on day 1~Methotrexate: Intrathecal administration~Vincristine: Intravenous push on days 1, 8, 15, 22~The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level."
10876005|NCT00440726|BG001|Baseline|Phase 1 Dose Level 2|If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level
10876006|NCT00440726|BG002|Baseline|Phase 2 Efficacy|"After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen.~Bortezomib (Velcade): Intravenous on days 1, 4, 8 and 11 at 1.3 mg/m2/day~Dexamethasone: Intravenous or oral administration for 14 days.~PEG-asparaginase: Intramuscular injection~Doxorubicin: Intravenous infusion~Cytarabine: Intrathecal administration on day 1~Methotrexate: Intrathecal administration~Vincristine: Intravenous push on days 1, 8, 15, 22"
10876007|NCT00440726|BG003|Baseline|Total|Total of all reporting groups
10876008|NCT00440726|FG000|Participant Flow|Phase 1: Cohort 1 Bortezomib 1mg/m2/Day (Dose Level 1)|The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level.
10876009|NCT00440726|FG001|Participant Flow|Phase 1: Cohort 2 Bortezomib 1.3 mg/m2/Day (Dose Level 2)|If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level.
10876010|NCT00440726|FG002|Participant Flow|Phase 2: Bortezomib 1.3 mg/m2/Day (Efficacy)|After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen.
10876011|NCT00440726|OG000|Outcome|Ph 1, Dose Level 1 (1 mg/m2)|Phase 1 patients receiving 1 mg/m2 dose of bortezomib
10876012|NCT00440726|OG001|Outcome|Ph 1, Dose Level 2 (1.3 mg/m2)|Phase 1 patients receiving 1.3 mg/m2 dose of bortezomib
10876013|NCT00440726|OG000|Outcome|Ph 1 Dose Escalation|Patients enrolled into the Phase 1 portion of the study
10876014|NCT00440726|OG001|Outcome|Ph 2 B-Precursor ALL Patients|Patients enrolled into the Phase 2 portion of the study having B-Precursor ALL
10876015|NCT00440726|OG002|Outcome|Ph 2 T-Cell ALL Patients|Patients enrolled into the Phase 2 portion of the study having T-Cell ALL
10876016|NCT00440726|OG000|Outcome|Phase 2 B-Precursor ALL Patients|Patients enrolled into the Phase 2 portion of the study having B-Precursor ALL
10876017|NCT00440726|OG001|Outcome|Phase 2 T-cell ALL Patients|Patients enrolled into the Phase 2 portion of the study having T-Cell ALL
10876018|NCT00440726|EG000|Reported Event|1 mg/m2 Dose Group|Patients receiving a 1 mg/m2 dose of bortezomib (known as Dose Level 1 in the Phase 1 portion). All patients in this group were from the Phase 1 portion of the study.
10876019|NCT00440726|EG001|Reported Event|1.3 mg/m2 Dose Group|Patients receiving a 1.3 mg/m2 dose of bortezomib (known as Dose Level 2 in the Phase 1 portion). This group includes patients from both the Phase 1 and Phase 2 portions of the study.
10876020|NCT00440830|BG000|Baseline|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
10876021|NCT00440830|BG001|Baseline|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
10876022|NCT00440830|BG002|Baseline|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10876023|NCT00440830|BG003|Baseline|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10876024|NCT00440830|BG004|Baseline|Total|Total of all reporting groups
10876025|NCT00440830|FG000|Participant Flow|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
10876026|NCT00440830|FG001|Participant Flow|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
10876027|NCT00440830|FG002|Participant Flow|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10876028|NCT00440830|FG003|Participant Flow|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10876029|NCT00440830|OG000|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
10876030|NCT00440830|OG001|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
10876031|NCT00440830|OG002|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10876032|NCT00440830|OG003|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10876033|NCT00440830|OG000|Outcome|Smokers-nicotine|"Smokers who were treated with nicotine~nicotine patch: nicotine patch (0,5,10 or 15mg/day) applied to smokers"
10876034|NCT00440830|OG001|Outcome|Nonsmokers-nicotine|"Nonsmokers who were treated with nicotine~nicotine patch: nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers"
10876035|NCT00440830|OG002|Outcome|Smokers-placebo|"Smokers who were treated with placebo~placebo: placebo patch applied to smokers"
10876036|NCT00440830|OG003|Outcome|Nonsmokers-placebo|"Nonsmokers who were treated with placebo~placebo: placebo patch applied to nonsmokers"
10876037|NCT00440830|EG000|Reported Event|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
10876038|NCT00440830|EG001|Reported Event|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
10876039|NCT00440830|EG002|Reported Event|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10876040|NCT00440830|EG003|Reported Event|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10876041|NCT00440947|BG000|Baseline|ABC/3TC + ATV/r|All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
10876042|NCT00440947|FG000|Participant Flow|ABC/3TC + ATV/r: Induction Phase|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
10876043|NCT00440947|FG001|Participant Flow|ABC/3TC + ATV: Randomization Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
10876044|NCT00440947|FG002|Participant Flow|ABC/3TC + ATV/r: Randomization Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
10876045|NCT00440947|FG003|Participant Flow|ABC/3TC + ATV: Extension Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
10876046|NCT00440947|FG004|Participant Flow|ABC/3TC + ATV/r: Extension Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
10876047|NCT00440947|OG000|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
10876048|NCT00440947|OG001|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
10876049|NCT00440947|OG000|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
10876050|NCT00440947|OG000|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
10876051|NCT00440947|OG001|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
10876052|NCT00440947|EG000|Reported Event|ABC/3TC + ATV/r: Induction Phase|Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
10876053|NCT00440947|EG001|Reported Event|ABC/3TC + ATV: Randomization Phase|Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase
10876054|NCT00440947|EG002|Reported Event|ABC/3TC + ATV/r: Randomization Phase|Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase
10876055|NCT00440947|EG003|Reported Event|ABC/3TC + ATV: Extension Phase|Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
10876056|NCT00440947|EG004|Reported Event|ABC/3TC + ATV/r: Extension Phase|participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
10876057|NCT00440999|BG000|Baseline|Pyronaridine - Artesunate|"Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2).~Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg."
10989593|NCT01000506|BG003|Baseline|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989594|NCT01000506|BG004|Baseline|Total|Total of all reporting groups
10989595|NCT01000506|FG000|Participant Flow|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989596|NCT01000506|FG001|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989597|NCT01000506|FG002|Participant Flow|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989598|NCT01000506|FG003|Participant Flow|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989599|NCT01000506|OG000|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989600|NCT01000506|OG001|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989601|NCT01000506|OG002|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989602|NCT01000506|OG003|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989603|NCT01000506|EG000|Reported Event|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989604|NCT01000506|EG001|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989605|NCT01000506|EG002|Reported Event|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989606|NCT01000506|EG003|Reported Event|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
10989607|NCT01000610|BG000|Baseline|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
10989608|NCT01000610|FG000|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenous (iv) infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (less than or equal to [≤] 10 milligrams per day (mg/day) prednisone or equivalent) or intra-articular corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs) and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone100 mg iv prior to each rituximab infusion.
10989609|NCT01000610|OG000|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
10989610|NCT01000610|EG000|Reported Event|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
10989611|NCT01000636|BG000|Baseline|Metvix PDT|
10989612|NCT01000636|FG000|Participant Flow|Metvix® Photodynamic Therapy (PDT)|
10989613|NCT01000636|OG000|Outcome|Metvix® Photodynamic Therapy (PDT)|
10989614|NCT01000636|EG000|Reported Event|Metvix® Photodynamic Therapy (PDT)|
10989615|NCT01000649|BG000|Baseline|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989616|NCT01000649|BG001|Baseline|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989617|NCT01000649|BG002|Baseline|FE 202158 3.75|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989618|NCT01000649|BG003|Baseline|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
10989619|NCT01000649|BG004|Baseline|Total|Total of all reporting groups
10989620|NCT01000649|FG000|Participant Flow|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989621|NCT01000649|FG001|Participant Flow|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
11007354|NCT01090414|EG002|Reported Event|101-08|Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.
10989622|NCT01000649|FG002|Participant Flow|FE 202158 3.75|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.The two patients randomized to FE 202158 3.75 ng group were excluded from the efficacy evaluation since meaningful analyses were not possible.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989623|NCT01000649|FG003|Participant Flow|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
10989624|NCT01000649|OG000|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989625|NCT01000649|OG001|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989626|NCT01000649|OG002|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
10989627|NCT01000649|EG000|Reported Event|FE 202158 1.25|"Patients in the arm received a continuous intravenous infusion of FE 202158 1.25 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989628|NCT01000649|EG001|Reported Event|FE 202158 2.5|"Patients in the arm received a continuous intravenous infusion of FE 202158 2.5 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989629|NCT01000649|EG002|Reported Event|FE 202158 3.75|"Patients in the arm received a continuous intravenous infusion of FE 202158 3.75 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
10989630|NCT01000649|EG003|Reported Event|PLCBO|Patients in the arm received a continuous intravenous infusion of isotonic saline up to seven consecutive days.
10989631|NCT01000662|BG000|Baseline|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
10989632|NCT01000662|BG001|Baseline|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
10989633|NCT01000662|BG002|Baseline|Total|Total of all reporting groups
10989634|NCT01000662|FG000|Participant Flow|ARM 1 Daily Boost|"Radiation Therapy~15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed."
10989635|NCT01000662|FG001|Participant Flow|ARM 2 Weekly Boost|"Radiation Therapy~15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
10989636|NCT01000662|OG000|Outcome|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
10989637|NCT01000662|OG001|Outcome|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
10989638|NCT01000662|OG000|Outcome|ARM 1 Daily Boost|"Radiation Therapy~15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed."
10989639|NCT01000662|OG001|Outcome|ARM 2 Weekly Boost|"Radiation Therapy~15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
10989640|NCT01000662|EG000|Reported Event|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
10989641|NCT01000662|EG001|Reported Event|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
10989642|NCT01000727|BG000|Baseline|Placebo|Participants were randomized to receive matching placebo once daily.
10989643|NCT01000727|BG001|Baseline|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
10989644|NCT01000727|BG002|Baseline|Total|Total of all reporting groups
10989645|NCT01000727|FG000|Participant Flow|Placebo|Participants were randomized to receive matching placebo once daily.
10989646|NCT01000727|FG001|Participant Flow|Darapladib 160 mg|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
10989647|NCT01000727|OG000|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
10989648|NCT01000727|OG001|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
10989649|NCT01000727|OG000|Outcome|Darapladib 160 mg|Participants were randomized to receive matching placebo once daily.
10989650|NCT01000727|OG001|Outcome|Placebo|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
10989651|NCT01000727|EG000|Reported Event|Placebo|Participants were randomized to receive matching placebo once daily.
10989652|NCT01000727|EG001|Reported Event|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
10989653|NCT01000805|BG000|Baseline|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
10989654|NCT01000805|BG001|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
10989655|NCT01000805|BG002|Baseline|Total|Total of all reporting groups
10989656|NCT01000805|FG000|Participant Flow|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
10989657|NCT01000805|FG001|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
10989658|NCT01000805|OG000|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
10989659|NCT01000805|OG001|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
10989660|NCT01000805|OG000|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
10989661|NCT01000805|EG000|Reported Event|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
10989662|NCT01000805|EG001|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
10989663|NCT01000818|BG000|Baseline|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day~Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day~Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
11336443|NCT03566810|BG002|Baseline|First Test GXR (Fed), Then Reference GXR (Fed)|Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong, China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GXR (Merck Darmstadt, Germany) on Day 8 in treatment period 2 under fed conditions. There was a wash-out period of 7 days between each treatment period.
10989664|NCT01000818|FG000|Participant Flow|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day~Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day~Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
10989665|NCT01000818|OG000|Outcome|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
10989666|NCT01000818|OG001|Outcome|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
10989667|NCT01000818|OG002|Outcome|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
10989668|NCT01000818|EG000|Reported Event|Prestudy|
10989669|NCT01000818|EG001|Reported Event|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
10989670|NCT01000818|EG002|Reported Event|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
10989671|NCT01000818|EG003|Reported Event|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
10989672|NCT01000961|BG000|Baseline|RP103 and Cystagon® Crossover|Per Protocol Population
10989673|NCT01000961|FG000|Participant Flow|Cystagon First, Then Cystagon, Then RP103|Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.
10989674|NCT01000961|FG001|Participant Flow|Cystagon First, Then RP103, Then Cystagon|RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
10989675|NCT01000961|OG000|Outcome|RP103|Per Protocol Population
10989676|NCT01000961|OG001|Outcome|Cystagon®|Per Protocol Population
10989677|NCT01000961|OG000|Outcome|Cystagon®|Per Protocol Population
10989678|NCT01000961|OG001|Outcome|RP103|Per Protocol Population
10989679|NCT01000961|EG000|Reported Event|RP103|Safety Population during treatment periods
10989680|NCT01000961|EG001|Reported Event|Cystagon®|Safety population during treatment periods
11336444|NCT03566810|BG003|Baseline|First Reference GXR (Fed), Then Test GXR (Fed)|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt, Germany) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GXR (Merck Nantong, China) on Day 8 in treatment period 2 under fed conditions. There was a wash-out period of 7 days between each treatment period.
10876058|NCT00440999|BG001|Baseline|Chloroquine|"Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2).~The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults."
10876059|NCT00440999|BG002|Baseline|Total|Total of all reporting groups
10876060|NCT00440999|FG000|Participant Flow|Pyronaridine - Artesunate|"Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2).~Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg."
10876061|NCT00440999|FG001|Participant Flow|Chloroquine|"Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2).~The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults."
10876062|NCT00440999|OG000|Outcome|Pyronaridine Artesunate|"Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2).~Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg."
10876063|NCT00440999|OG001|Outcome|Chloroquine|"Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2).~The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults."
10876064|NCT00440999|OG000|Outcome|Pyronaridine Artesunate|"Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2).~Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg."
10876065|NCT00440999|OG001|Outcome|Chloroquine|"Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2).~The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults."
10876066|NCT00440999|EG000|Reported Event|Pyronaridine Artesunate|"Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2).~Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg."
10876067|NCT00440999|EG001|Reported Event|Chloroquine|"Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2).~The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults."
10876068|NCT00441012|BG000|Baseline|Modified Process Vaccine|"Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)~1 participant randomized but not vaccinated in the Modified Process Vaccine group; overall N is 269, not 270."
10876069|NCT00441012|BG001|Baseline|COMVAX™|"COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)~3 participants in the COMVAX™ group vaccinated but not randomized; overall N is 276, not 273 - due to issues randomizing via IVRS, in violation, all 3 participants were vaccinated as randomly assigned by the Investigator."
10876070|NCT00441012|BG002|Baseline|Total|Total of all reporting groups
10876071|NCT00441012|FG000|Participant Flow|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
10876072|NCT00441012|FG001|Participant Flow|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
10876073|NCT00441012|OG000|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
10876074|NCT00441012|OG001|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
10876075|NCT00441012|EG000|Reported Event|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
10876076|NCT00441012|EG001|Reported Event|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
10876077|NCT00441064|BG000|Baseline|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks and high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
10876078|NCT00441064|BG001|Baseline|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
10876079|NCT00441064|BG002|Baseline|Total|Total of all reporting groups
10876080|NCT00441064|FG000|Participant Flow|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks who crossed over to the high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
10876081|NCT00441064|FG001|Participant Flow|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and crossed over to the low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
10876082|NCT00441064|OG000|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
10876083|NCT00441064|OG001|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
10876084|NCT00441064|EG000|Reported Event|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet.
10876085|NCT00441064|EG001|Reported Event|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet.
10876086|NCT00441090|BG000|Baseline|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
10876087|NCT00441090|BG001|Baseline|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
10876088|NCT00441090|BG002|Baseline|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
10876089|NCT00441090|BG003|Baseline|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
10989681|NCT01000974|BG000|Baseline|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
10989682|NCT01000974|BG001|Baseline|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
10989683|NCT01000974|BG002|Baseline|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
10989684|NCT01000974|BG003|Baseline|Total|Total of all reporting groups
10989685|NCT01000974|FG000|Participant Flow|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
10989686|NCT01000974|FG001|Participant Flow|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
10989687|NCT01000974|FG002|Participant Flow|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
10989688|NCT01000974|OG000|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
10989689|NCT01000974|OG001|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
10989690|NCT01000974|OG002|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
10989691|NCT01000974|OG000|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally
10989692|NCT01000974|OG001|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally
10989693|NCT01000974|OG001|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
10989694|NCT01000974|EG000|Reported Event|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
10989695|NCT01000974|EG001|Reported Event|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
10989696|NCT01000974|EG002|Reported Event|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
10989697|NCT01000987|BG000|Baseline|1 mg/Day Varenicline|"varenicline 1mg/day~varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
10989698|NCT01000987|BG001|Baseline|2 mg/Day Varenicline|"varenicline 2mg/day~varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
10989699|NCT01000987|BG002|Baseline|Placebo|"placebo~placebo: placebo"
10989700|NCT01000987|BG003|Baseline|Total|Total of all reporting groups
10989701|NCT01000987|FG000|Participant Flow|1 mg/Day Varenicline|"varenicline 1mg/day~varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
10989702|NCT01000987|FG001|Participant Flow|2 mg/Day Varenicline|"varenicline 2mg/day~varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
10989703|NCT01000987|FG002|Participant Flow|Placebo|"placebo~placebo: placebo"
10989704|NCT01000987|OG000|Outcome|1 mg/Day Varenicline|"varenicline 1mg/day~varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
10989705|NCT01000987|OG001|Outcome|2 mg/Day Varenicline|"varenicline 2mg/day~varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
10989706|NCT01000987|OG002|Outcome|Placebo|"placebo~placebo: placebo"
10989707|NCT01000987|EG000|Reported Event|1 mg/Day Varenicline|"varenicline 1mg/day~varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
10989708|NCT01000987|EG001|Reported Event|2 mg/Day Varenicline|"varenicline 2mg/day~varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
10989709|NCT01000987|EG002|Reported Event|Placebo|"placebo~placebo: placebo"
10989710|NCT01001052|BG000|Baseline|Colcrys™ - Young Subjects and Colcrys™ - Elderly Subjects|"Colcrys™ (colchicine) - young subjects (18-30 years): All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.~Colcrys™ (colchicine) - Elderly subjects (≥60 years): All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours."
10989711|NCT01001052|FG000|Participant Flow|Colcrys™ (Colchicine) - Young Subjects (18-30 Years)|All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
10989712|NCT01001052|FG001|Participant Flow|Colcrys™ (Colchicine) - Elderly Subjects (>60 Years)|All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
10989713|NCT01001052|OG000|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
10989714|NCT01001052|OG001|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
10989715|NCT01001052|EG000|Reported Event|Colcrys™ - Young Subjects (18-30 Years)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
10989716|NCT01001052|EG001|Reported Event|Colcrys™ - Elderly Subjects (>60 Years Old)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
11007355|NCT01090414|EG003|Reported Event|101-10|Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
11336445|NCT03566810|BG004|Baseline|Total|Total of all reporting groups
10876090|NCT00441090|BG004|Baseline|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
10876091|NCT00441090|BG005|Baseline|Total|Total of all reporting groups
10876092|NCT00441090|FG000|Participant Flow|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
10876093|NCT00441090|FG001|Participant Flow|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
10876094|NCT00441090|FG002|Participant Flow|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
10876095|NCT00441090|FG003|Participant Flow|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
10876096|NCT00441090|FG004|Participant Flow|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
10876097|NCT00441090|OG000|Outcome|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
10876098|NCT00441090|OG001|Outcome|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
10876099|NCT00441090|OG002|Outcome|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
10876100|NCT00441090|OG003|Outcome|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
10876101|NCT00441090|OG004|Outcome|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
10876102|NCT00441090|EG000|Reported Event|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
10876103|NCT00441090|EG001|Reported Event|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
10876104|NCT00441090|EG002|Reported Event|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
10876105|NCT00441090|EG003|Reported Event|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
10876106|NCT00441090|EG004|Reported Event|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
10876107|NCT00441103|BG000|Baseline|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
10876108|NCT00441103|BG001|Baseline|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
10876109|NCT00441103|BG002|Baseline|Total|Total of all reporting groups
10876110|NCT00441103|FG000|Participant Flow|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 microgram (mcg) administered subcutaneously three times a week for 40 weeks.
10876111|NCT00441103|FG001|Participant Flow|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
10876112|NCT00441103|OG000|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
10876113|NCT00441103|OG001|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
10876114|NCT00441103|OG000|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
10876115|NCT00441103|EG000|Reported Event|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
10876116|NCT00441103|EG001|Reported Event|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
10876117|NCT00441116|BG000|Baseline|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
10876118|NCT00441116|BG001|Baseline|Placebo|Subjects who were given no Investigational product.
10876119|NCT00441116|BG002|Baseline|Total|Total of all reporting groups
10876120|NCT00441116|FG000|Participant Flow|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
10876121|NCT00441116|FG001|Participant Flow|Placebo|Subjects who were given no Investigational product.
10876122|NCT00441116|OG000|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
10876123|NCT00441116|OG001|Outcome|Placebo|Subjects who were given no Investigational product.
10876124|NCT00441116|EG000|Reported Event|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
10876125|NCT00441116|EG001|Reported Event|Placebo|Subjects who were given no Investigational product.
10876126|NCT00441129|BG000|Baseline|Conventional Insulin Pump Therapy|"Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)~Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump"
10876127|NCT00441129|BG001|Baseline|Minimed Paradigm Real Time Sytem|"Minimed paradigm Real Time Sytem~Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem"
10876128|NCT00441129|BG002|Baseline|Total|Total of all reporting groups
10876129|NCT00441129|FG000|Participant Flow|Conventional Insulin Pump Therapy|"Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)~Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump"
10876130|NCT00441129|FG001|Participant Flow|Minimed Paradigm Real Time Sytem|"Minimed paradigm Real Time Sytem~Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem"
10876131|NCT00441129|OG000|Outcome|Conventional Insulin Pump Therapy|"Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)~Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump"
10876132|NCT00441129|OG001|Outcome|Minimed Paradigm Real Time Sytem|"Minimed paradigm Real Time Sytem~Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem"
10989717|NCT01001078|BG000|Baseline|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
10989718|NCT01001078|BG001|Baseline|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
10989719|NCT01001078|BG002|Baseline|Total|Total of all reporting groups
10989720|NCT01001078|FG000|Participant Flow|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
10989721|NCT01001078|FG001|Participant Flow|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
10989722|NCT01001078|OG000|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
10989723|NCT01001078|OG001|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
10989724|NCT01001078|OG000|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
10989725|NCT01001078|OG001|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
10989726|NCT01001078|EG000|Reported Event|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
10989727|NCT01001078|EG001|Reported Event|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
10989728|NCT01001104|BG000|Baseline|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
10989729|NCT01001104|BG001|Baseline|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989730|NCT01001104|BG002|Baseline|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989731|NCT01001104|BG003|Baseline|Placebo|Administered by SC injection, QW for 12 weeks.
10989732|NCT01001104|BG004|Baseline|Total|Total of all reporting groups
10989733|NCT01001104|FG000|Participant Flow|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
10989734|NCT01001104|FG001|Participant Flow|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989735|NCT01001104|FG002|Participant Flow|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989736|NCT01001104|FG003|Participant Flow|Placebo|Administered by SC injection, QW for 12 weeks.
10989737|NCT01001104|OG000|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
10989738|NCT01001104|OG001|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989739|NCT01001104|OG002|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989740|NCT01001104|OG003|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
10989741|NCT01001104|OG000|Outcome|LY 0.25 mg|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
10989742|NCT01001104|OG001|Outcome|LY 0.50 mg|Administered by SC injection, QW for 12 weeks.
10989743|NCT01001104|OG002|Outcome|LY 0.75 mg|Administered by SC injection, QW for 12 weeks.
10989744|NCT01001104|EG000|Reported Event|Placebo|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
10989745|NCT01001104|EG001|Reported Event|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989746|NCT01001104|EG002|Reported Event|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989747|NCT01001104|EG003|Reported Event|0.75 mg LY2189265|Administered by SC injection, QW for 12 weeks.
10989748|NCT01001169|BG000|Baseline|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
10989749|NCT01001169|BG001|Baseline|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989750|NCT01001169|BG002|Baseline|Total|Total of all reporting groups
10989751|NCT01001169|FG000|Participant Flow|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
10989752|NCT01001169|FG001|Participant Flow|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989753|NCT01001169|OG000|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
10989754|NCT01001169|OG001|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989755|NCT01001169|OG002|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
10989756|NCT01001169|OG003|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989757|NCT01001169|OG000|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
10989758|NCT01001169|OG001|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989759|NCT01001169|OG000|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
10989760|NCT01001169|OG001|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989761|NCT01001169|OG002|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989762|NCT01001169|OG000|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989763|NCT01001169|EG000|Reported Event|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
10989764|NCT01001169|EG001|Reported Event|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
10989765|NCT01001195|BG000|Baseline|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989766|NCT01001195|BG001|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989767|NCT01001195|BG002|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989768|NCT01001195|BG003|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989769|NCT01001195|BG004|Baseline|Total|Total of all reporting groups
10989770|NCT01001195|FG000|Participant Flow|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989771|NCT01001195|FG001|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989772|NCT01001195|FG002|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989773|NCT01001195|FG003|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989774|NCT01001195|OG000|Outcome|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989775|NCT01001195|OG001|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989776|NCT01001195|OG002|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989777|NCT01001195|OG003|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989778|NCT01001195|EG000|Reported Event|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989779|NCT01001195|EG001|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989780|NCT01001195|EG002|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989781|NCT01001195|EG003|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
10989782|NCT01001208|BG000|Baseline|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
10989783|NCT01001208|BG001|Baseline|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
10989784|NCT01001208|BG002|Baseline|Total|Total of all reporting groups
10989785|NCT01001208|FG000|Participant Flow|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
10989786|NCT01001208|FG001|Participant Flow|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
11007356|NCT01090427|BG000|Baseline|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
10989787|NCT01001208|OG000|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
10989788|NCT01001208|OG001|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
10989789|NCT01001208|EG000|Reported Event|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
10989790|NCT01001208|EG001|Reported Event|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
10989791|NCT01001221|BG000|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989792|NCT01001221|BG001|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989793|NCT01001221|BG002|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989794|NCT01001221|BG003|Baseline|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989795|NCT01001221|BG004|Baseline|Total|Total of all reporting groups
10989796|NCT01001221|FG000|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989797|NCT01001221|FG001|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989798|NCT01001221|FG002|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989799|NCT01001221|FG003|Participant Flow|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989800|NCT01001221|FG004|Participant Flow|Part 2: Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the Maximum Tolerated Dose (MTD) as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989801|NCT01001221|OG000|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989802|NCT01001221|OG001|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989803|NCT01001221|OG002|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989804|NCT01001221|OG003|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989805|NCT01001221|OG000|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989806|NCT01001221|EG000|Reported Event|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989807|NCT01001221|EG001|Reported Event|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989808|NCT01001221|EG002|Reported Event|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989809|NCT01001221|EG003|Reported Event|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
10989810|NCT01001299|BG000|Baseline|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
10989811|NCT01001299|FG000|Participant Flow|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 milligrams [mg] tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 milligrams per kilogram [mg/kg] syrup) on Day 1, followed by 5-day washout. Vemurafenib (RO5185426) 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
10989812|NCT01001299|OG000|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
10989813|NCT01001299|EG000|Reported Event|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
10989814|NCT01001325|BG000|Baseline|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
10989815|NCT01001325|BG001|Baseline|Placebo|0.5 mL normal saline
11223216|NCT02351934|OG001|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
11223217|NCT02351934|EG000|Reported Event|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
11223218|NCT02351934|EG001|Reported Event|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
11223219|NCT02351960|BG000|Baseline|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
11223220|NCT02351960|BG001|Baseline|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
11223221|NCT02351960|BG002|Baseline|Total|Total of all reporting groups
11223222|NCT02351960|FG000|Participant Flow|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
11223223|NCT02351960|FG001|Participant Flow|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
11223224|NCT02351960|OG000|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
11223225|NCT02351960|OG000|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
11223226|NCT02351960|OG001|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
10989816|NCT01001325|BG002|Baseline|Total|Total of all reporting groups
10989817|NCT01001325|FG000|Participant Flow|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
10989818|NCT01001325|FG001|Participant Flow|Placebo|0.5 mL normal saline
10989819|NCT01001325|OG000|Outcome|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
10989820|NCT01001325|OG001|Outcome|Placebo|0.5 mL normal saline
11223227|NCT02351960|EG000|Reported Event|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
10989821|NCT01001325|EG000|Reported Event|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
10989822|NCT01001325|EG001|Reported Event|Placebo|0.5 mL normal saline
10989823|NCT01001377|BG000|Baseline|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
10989824|NCT01001377|BG001|Baseline|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
10989825|NCT01001377|BG002|Baseline|Total|Total of all reporting groups
10989826|NCT01001377|FG000|Participant Flow|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
10876133|NCT00441129|EG000|Reported Event|Conventional Insulin Pump Therapy|"Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)~Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump"
10876134|NCT00441129|EG001|Reported Event|Minimed Paradigm Real Time Sytem|"Minimed paradigm Real Time Sytem~Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem"
10876135|NCT00441142|BG000|Baseline|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876136|NCT00441142|BG001|Baseline|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876137|NCT00441142|BG002|Baseline|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
10876138|NCT00441142|BG003|Baseline|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876139|NCT00441142|BG004|Baseline|Total|Total of all reporting groups
10876140|NCT00441142|FG000|Participant Flow|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10879429|NCT00457743|BG000|Baseline|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
10879430|NCT00457743|BG001|Baseline|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
10876141|NCT00441142|FG001|Participant Flow|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876142|NCT00441142|FG002|Participant Flow|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
10876143|NCT00441142|FG003|Participant Flow|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876144|NCT00441142|OG000|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876145|NCT00441142|OG001|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876146|NCT00441142|OG002|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
10876147|NCT00441142|OG003|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876148|NCT00441142|OG000|Outcome|Phase II - Arm A - Participants|Phase II Control Arm: Arm A (RT + TMZ)
10876149|NCT00441142|OG001|Outcome|Phase II - Arm B - Participants|Phase II Treatment Arm: Arm B (RT + TMZ + Vandetanib)
10876150|NCT00441142|OG000|Outcome|Phase I Participants - Vandetanib @ 200 mg/Day|Phase I Participants (RT + TMZ + Vandetanib): Cohorts 1 & 2 (Vandetanib @ 200 mg/day)
10876151|NCT00441142|OG001|Outcome|Phase I Participants - Vandetanib @ 100 mg/Day|Phase I Participants (RT + TMZ + Vandetanib): Cohorts 3 & 4 (Vandetanib @ 100 mg/day)
10989827|NCT01001377|FG001|Participant Flow|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
10989828|NCT01001377|OG000|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
10989829|NCT01001377|OG001|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
10989830|NCT01001377|EG000|Reported Event|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
10989831|NCT01001377|EG001|Reported Event|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
10989832|NCT01001403|BG000|Baseline|Nafamostat|
10989833|NCT01001403|BG001|Baseline|Control|
10989834|NCT01001403|BG002|Baseline|Total|Total of all reporting groups
10989835|NCT01001403|FG000|Participant Flow|Nafamostat|
10989836|NCT01001403|FG001|Participant Flow|Control|
10989837|NCT01001403|OG000|Outcome|Nafamostat|
10989838|NCT01001403|OG001|Outcome|Control|
10989839|NCT01001403|EG000|Reported Event|Nafamostat|
10989840|NCT01001403|EG001|Reported Event|Control|
10989841|NCT01001429|BG000|Baseline|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
10989842|NCT01001429|BG001|Baseline|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
10989843|NCT01001429|BG002|Baseline|Total|Total of all reporting groups
10989844|NCT01001429|FG000|Participant Flow|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
10989845|NCT01001429|FG001|Participant Flow|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
10989846|NCT01001429|OG000|Outcome|BIS Scores in Propofol Infusion Group|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
10989847|NCT01001429|OG001|Outcome|BIS Scores in Dexmedetomidine Infusion Group|"Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
10989848|NCT01001429|OG002|Outcome|UMSS Scores in Propofol Infusion Group|Propofol medication administered as described in BIS group/Propofol group
10989849|NCT01001429|OG003|Outcome|UMSS in Dexmedetomidine Infusion Group|subject received medication as described in BIS/dexmedetomidine
10989850|NCT01001429|OG000|Outcome|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
10989851|NCT01001429|OG001|Outcome|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
10989852|NCT01001429|OG000|Outcome|Propofol Group -Mean Systolic Blood Pressure|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
10989853|NCT01001429|OG001|Outcome|Dexmedetomidine Group-mean Systolic Blood Pressure|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
10989854|NCT01001429|OG002|Outcome|Propofol Group- Mean Diastolic Blood Pressure|propofol administered as described- blood pressure recorded at 5 min intervals during surgery
10989855|NCT01001429|OG003|Outcome|Dexmedetomidine Group- Mean Diastolic Blood Pressure|dexmedetomidine as already described and blood pressure monitored 5 min intervals,
10989856|NCT01001429|OG000|Outcome|Propofol Group|subjects randomized to propofol group had their respiratory rate recorded at 5 minute intervals during the operative procedure.
10989857|NCT01001429|OG001|Outcome|Dexmedetomidine Group|subjects randomized to dexmedetomidine group had their respiratory rate recorded at 5 minute intervals during the operative procedure
10989858|NCT01001429|OG000|Outcome|Propofol Group|Heart rate recorded at 5 minute intervals during procedure for subjects randomized to propofol
10989859|NCT01001429|OG001|Outcome|Dexmedetomidine|Heart rate recorded at 5 minute interval for subjects randomized to dexmedetomidine
10989860|NCT01001429|OG000|Outcome|Propofol Group|surgeon satisfaction at 10 minutes in to the procedure for subjects randomized to propofol
10989861|NCT01001429|OG001|Outcome|Dexmedetomidine Group|surgeon satisfaction at 10 minutes into the procedure
10989862|NCT01001429|OG000|Outcome|Propofol Group|patients receiving comparison drug propofol
10989863|NCT01001429|OG001|Outcome|Dexmedetomidine Group|patients receiving study drug dexmedetomidine
10989864|NCT01001429|OG000|Outcome|Propofol|patient satisfaction prior to discharge on a 5 point scale1=very poor, 2=poor, 3=fair, 4= good , 5=excellent
10989865|NCT01001429|OG001|Outcome|Dexmedetomidine Group|"patient satisfaction~1=very poor, 2=poor, 3=fair, 4= good, 5=excellent"
10989866|NCT01001429|OG000|Outcome|Propofol Group|systolic blood pressure at 30 min intervals in PACU
10989867|NCT01001429|OG001|Outcome|Dexmedetomidine Group|systolic blood pressure measured at 3 0 min. intervals in PACU
10989868|NCT01001429|OG002|Outcome|Propofol|diastolic blood pressure recorded every 30 min in PACU
10989869|NCT01001429|OG003|Outcome|Dexmedetomidine|diastolic pressure measured every 30 min in PACU
10989870|NCT01001429|OG000|Outcome|Propofol Group|heart rate recorded in 30 min intervals in PACU ( 2 hours)
10989871|NCT01001429|OG001|Outcome|Dexmedetomidine|heart rate recorded at at 30 min intervals while in PACU (2 hours)
10989872|NCT01001429|EG000|Reported Event|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
10989873|NCT01001429|EG001|Reported Event|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
11223228|NCT02351960|EG001|Reported Event|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
10876152|NCT00441142|EG000|Reported Event|Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
10876153|NCT00441142|EG001|Reported Event|Phase II-Arm A Pts (Control Group): RT + TMZ|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
10876154|NCT00441168|BG000|Baseline|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
10876155|NCT00441168|BG001|Baseline|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
10876156|NCT00441168|BG002|Baseline|Total|Total of all reporting groups
10876157|NCT00441168|FG000|Participant Flow|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
10876158|NCT00441168|FG001|Participant Flow|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
10876159|NCT00441168|OG000|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
10876160|NCT00441168|OG001|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
10876161|NCT00441168|EG000|Reported Event|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
10876162|NCT00441168|EG001|Reported Event|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
10876163|NCT00441259|BG000|Baseline|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
10876164|NCT00441259|BG001|Baseline|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
10876165|NCT00441259|BG002|Baseline|Total|Total of all reporting groups
10876166|NCT00441259|FG000|Participant Flow|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
10876167|NCT00441259|FG001|Participant Flow|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
10876168|NCT00441259|OG000|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
10876169|NCT00441259|OG001|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
10876170|NCT00441259|EG000|Reported Event|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
10876171|NCT00441259|EG001|Reported Event|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
10876172|NCT00441285|BG000|Baseline|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
10876173|NCT00441285|BG001|Baseline|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
10876174|NCT00441285|BG002|Baseline|Phase III Trial ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~A placebo of ABZ was added to complete to the doses in the Increased ABZ arm~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 10 days."
10989874|NCT01001442|BG000|Baseline|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989875|NCT01001442|BG001|Baseline|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989876|NCT01001442|BG002|Baseline|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989877|NCT01001442|BG003|Baseline|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989878|NCT01001442|BG004|Baseline|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989879|NCT01001442|BG005|Baseline|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989880|NCT01001442|BG006|Baseline|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989881|NCT01001442|BG007|Baseline|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989882|NCT01001442|BG008|Baseline|Total|Total of all reporting groups
10989883|NCT01001442|FG000|Participant Flow|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989884|NCT01001442|FG001|Participant Flow|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989885|NCT01001442|FG002|Participant Flow|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989886|NCT01001442|FG003|Participant Flow|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989887|NCT01001442|FG004|Participant Flow|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989888|NCT01001442|FG005|Participant Flow|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989889|NCT01001442|FG006|Participant Flow|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989890|NCT01001442|FG007|Participant Flow|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989891|NCT01001442|OG000|Outcome|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989892|NCT01001442|OG001|Outcome|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989893|NCT01001442|OG002|Outcome|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989894|NCT01001442|OG003|Outcome|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989895|NCT01001442|OG004|Outcome|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989896|NCT01001442|OG005|Outcome|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989897|NCT01001442|OG006|Outcome|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989898|NCT01001442|OG007|Outcome|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989899|NCT01001442|OG008|Outcome|Total|BT062 administration (all dose levels)
10989900|NCT01001442|OG000|Outcome|BT062|BT062: intravenous administration
10989901|NCT01001442|OG008|Outcome|Total|BT062 Administration (all dose levels)
10989902|NCT01001442|EG000|Reported Event|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989903|NCT01001442|EG001|Reported Event|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989904|NCT01001442|EG002|Reported Event|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989905|NCT01001442|EG003|Reported Event|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989906|NCT01001442|EG004|Reported Event|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989907|NCT01001442|EG005|Reported Event|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989908|NCT01001442|EG006|Reported Event|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989909|NCT01001442|EG007|Reported Event|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
10989910|NCT01001442|EG008|Reported Event|Total|BT062 administration (all dose levels)
10989911|NCT01001494|BG000|Baseline|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
10989912|NCT01001494|BG001|Baseline|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
10989913|NCT01001494|BG002|Baseline|Placebo|Placebo via inhalation
10989914|NCT01001494|BG003|Baseline|Total|Total of all reporting groups
10989915|NCT01001494|FG000|Participant Flow|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
10989916|NCT01001494|FG001|Participant Flow|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
10989917|NCT01001494|FG002|Participant Flow|Placebo|Placebo via inhalation
10989918|NCT01001494|OG000|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
10989919|NCT01001494|OG001|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
10989920|NCT01001494|OG002|Outcome|Placebo|Placebo via inhalation
10989921|NCT01001494|EG000|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
10989922|NCT01001494|EG001|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
10989923|NCT01001494|EG002|Reported Event|Placebo|Placebo via inhalation
10989924|NCT01001520|BG000|Baseline|Entire Study Population|Includes all subjects who were randomized to both study treatment groups (i.e., receive both placebo first and tolcapone first) and initiated study medication.
10989925|NCT01001520|FG000|Participant Flow|Placebo First, Then Tolcapone|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.~Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took placebo during the first medication period, followed by tolcapone during the second medication period.~During the placebo medication period, subjects followed a medication regimen and took capsules that were identical to those in the active tolcapone medication period (see protocol section for complete description)."
10989926|NCT01001520|FG001|Participant Flow|Tolcapone First, Then Placebo|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.~Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took tolcapone during the first medication period, followed by a placebo during the second medication period.~During the active tolcapone medication period, subjects followed a tapered dosing schedule (see protocol section for complete description)."
10989927|NCT01001520|OG000|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
10989928|NCT01001520|OG001|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)"
10989929|NCT01001520|OG001|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
10989930|NCT01001520|OG000|Outcome|Placebo|"See Protocol or Participant Flow sections for full description of this study arm."
10989931|NCT01001520|OG001|Outcome|Tolcapone|"See Protocol or Participant Flow sections for full description of this study arm."
10989932|NCT01001520|EG000|Reported Event|Placebo|"11-day placebo-controlled medication period. Placebo capsules are identical to those in the active tolcapone treatment. When taking placebo, subjects follow an identical dosing schedule as the active treatment period.~Placebo: Participants will be asked to take study medication each day for both 11-day study medication periods.~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
10989933|NCT01001520|EG001|Reported Event|Tolcapone|"11-day phase, tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily); oral dosing; medication is encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)~Tolcapone: Participants will be asked to take study medication each day for both 11-day study medication periods.~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
10989934|NCT01001546|BG000|Baseline|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
10989935|NCT01001546|BG001|Baseline|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
10989936|NCT01001546|BG002|Baseline|Total|Total of all reporting groups
10989937|NCT01001546|FG000|Participant Flow|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
10989938|NCT01001546|FG001|Participant Flow|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
10989939|NCT01001546|OG000|Outcome|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
10989940|NCT01001546|OG001|Outcome|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
10989941|NCT01001546|EG000|Reported Event|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
10989942|NCT01001546|EG001|Reported Event|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
10989943|NCT01001559|BG000|Baseline|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
10989944|NCT01001559|BG001|Baseline|Antidepressant Alone|SSRI or SNRI alone
10989945|NCT01001559|BG002|Baseline|Total|Total of all reporting groups
10989946|NCT01001559|FG000|Participant Flow|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
10989947|NCT01001559|FG001|Participant Flow|Antidepressant Alone|SSRI or SNRI alone
10989948|NCT01001559|OG000|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
10989949|NCT01001559|OG001|Outcome|Antidepressant Alone|SSRI or SNRI alone
10989950|NCT01001559|EG000|Reported Event|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
10989951|NCT01001559|EG001|Reported Event|Antidepressant Alone|SSRI or SNRI alone
10989952|NCT01001572|BG000|Baseline|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
10989953|NCT01001572|BG001|Baseline|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
10989954|NCT01001572|BG002|Baseline|Total|Total of all reporting groups
10989955|NCT01001572|FG000|Participant Flow|Single-Blind Run -In Valsartan 160 mg|Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
10989956|NCT01001572|FG001|Participant Flow|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
10989957|NCT01001572|FG002|Participant Flow|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
10989958|NCT01001572|OG000|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
10989959|NCT01001572|OG001|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
10989960|NCT01001572|EG000|Reported Event|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
10989961|NCT01001572|EG001|Reported Event|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
10989962|NCT01001598|BG000|Baseline|Danazol|"Subjects with either Fanconi anemia or Dyskeratosis congenita~danazol: Dosage is done according to weight; capsules are 50, 100, 200 mg"
10989963|NCT01001598|FG000|Participant Flow|Danazol|Subjects with either Fanconi anemia or Dyskeratosis congenita enter a single arm 24 week danazol dose escalation study: Dosage 5mg/kg/d; if no response at 12 weeks increase to 10 mg/kg/d; if no response at 18 weeks increase to 15 mg/kg/d. If no response stop at 24 weeks. Responders continue danazol at discretion of PCP.
10989964|NCT01001598|OG000|Outcome|Danazol|Subjects with either Fanconi anemia or Dyskeratosis congenita enter a single arm 24 week danazol dose escalation study: Dosage 5mg/kg/d; if no response at 12 weeks increase to 10 mg/kg/d; if no response at 18 weeks increase to 15 mg/kg/d. If no response stop at 24 weeks. Responders continue danazol at discretion of PCP.
10989965|NCT01001598|EG000|Reported Event|Single Arm Phase I/II Study|
10989966|NCT01001702|BG000|Baseline|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
10989967|NCT01001702|FG000|Participant Flow|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
10989968|NCT01001702|OG000|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
10989969|NCT01001702|EG000|Reported Event|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
10989970|NCT01001767|BG000|Baseline|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
10989971|NCT01001767|BG001|Baseline|Placebo|Placebo capsule by mouth twice a day x 24 weeks
10989972|NCT01001767|BG002|Baseline|Total|Total of all reporting groups
10989973|NCT01001767|FG000|Participant Flow|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
10989974|NCT01001767|FG001|Participant Flow|Placebo|Placebo capsule by mouth twice a day x 24 weeks
10989975|NCT01001767|OG000|Outcome|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
10989976|NCT01001767|OG001|Outcome|Placebo|Placebo capsule by mouth twice a day x 24 weeks
10989977|NCT01001767|EG000|Reported Event|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
10989978|NCT01001767|EG001|Reported Event|Placebo|Placebo capsule by mouth twice a day x 24 weeks
10989979|NCT01001806|BG000|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
10989980|NCT01001806|BG001|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
10989981|NCT01001806|BG002|Baseline|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
10989982|NCT01001806|BG003|Baseline|Total|Total of all reporting groups
10989983|NCT01001806|FG000|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
10989984|NCT01001806|FG001|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
10989985|NCT01001806|FG002|Participant Flow|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
10989986|NCT01001806|OG000|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
10989987|NCT01001806|OG001|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
10989988|NCT01001806|OG002|Outcome|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
10989989|NCT01001806|EG000|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
10989990|NCT01001806|EG001|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
10876175|NCT00441285|BG003|Baseline|Phase III Trial Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
10876176|NCT00441285|BG004|Baseline|Phase III Trial Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~A placebo of ABZ was added to complete the doses to the dosage in the Increased ABZ arm~Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
10876177|NCT00441285|BG005|Baseline|Total|Total of all reporting groups
10876178|NCT00441285|FG000|Participant Flow|PK Substudy ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
10876179|NCT00441285|FG001|Participant Flow|PK Substudy ABZ+Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
10876180|NCT00441285|FG002|Participant Flow|Phase III Trial - ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
10876181|NCT00441285|FG003|Participant Flow|Phase III Trial - Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d, for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
10876182|NCT00441285|FG004|Participant Flow|Phase III Trial - Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)~Placebo of Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
10876183|NCT00441285|OG000|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
10876184|NCT00441285|OG001|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
10876185|NCT00441285|OG000|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg/kg/day, divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg/day, for 10 days.~Praziquantel was given at 50 mg/kg/day, divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g/day,for 9 1/2 days."
10876186|NCT00441285|OG000|Outcome|Carbamazepine|Area Under the Curve of Praziquantel in Patients Receiving Carbamazepine
10876187|NCT00441285|OG001|Outcome|Phenytoin|Area Under the Curve of Praziquantel in Patients Receiving Phenytoin
10876188|NCT00441285|OG000|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
10876189|NCT00441285|OG001|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
10876190|NCT00441285|OG002|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
10876191|NCT00441285|EG000|Reported Event|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
10876192|NCT00441285|EG001|Reported Event|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
10876193|NCT00441337|BG000|Baseline|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10989991|NCT01001806|EG002|Reported Event|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
10989992|NCT01001832|BG000|Baseline|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
10989993|NCT01001832|BG001|Baseline|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
10989994|NCT01001832|BG002|Baseline|Total|Total of all reporting groups
10989995|NCT01001832|FG000|Participant Flow|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
10989996|NCT01001832|FG001|Participant Flow|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
10989997|NCT01001832|OG000|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
10989998|NCT01001832|OG001|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
10989999|NCT01001832|OG000|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
10990000|NCT01001832|OG001|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
10990001|NCT01001832|EG000|Reported Event|Abatacept Long-term (LT) SC 125 mg|Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo). Follow-up was up to 168 days after the last dose of drug.
10990002|NCT01001832|EG001|Reported Event|Short Term Intravenous (IV) Abatacept, 125 mg|Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
10990003|NCT01001832|EG002|Reported Event|Short Term Subcutaneous (SC) Abatacept, 125 mg|Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
10990004|NCT01001910|BG000|Baseline|Treatment (Pemetrexed Disodium, Carboplatin)|"Patients receive pemetrexed disodium IV over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10990005|NCT01001910|FG000|Participant Flow|Treatment (Pemetrexed Disodium, Carboplatin)|"Patients receive pemetrexed disodium IV over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10990006|NCT01001910|OG000|Outcome|Treatment (Pemetrexed Disodium, Carboplatin)|"Patients receive pemetrexed disodium IV over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10990007|NCT01001910|EG000|Reported Event|Treatment (Pemetrexed Disodium, Carboplatin)|"Patients receive pemetrexed disodium IV over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
10990008|NCT01001975|BG000|Baseline|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
10990009|NCT01001975|BG001|Baseline|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
10990010|NCT01001975|BG002|Baseline|Total|Total of all reporting groups
10990011|NCT01001975|FG000|Participant Flow|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
10990012|NCT01001975|FG001|Participant Flow|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
10990013|NCT01001975|OG000|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
10990014|NCT01001975|OG001|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
10990015|NCT01001975|EG000|Reported Event|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
10990016|NCT01001975|EG001|Reported Event|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
10990017|NCT01001988|BG000|Baseline|Study Group|Participants received a single dose of JE-CV in Study JEC02
10990018|NCT01001988|FG000|Participant Flow|Study Group|Participants received a single dose of JE-CV in Study JEC02 (NCT00735644)
10990019|NCT01001988|OG000|Outcome|Study Group|Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
10990020|NCT01001988|EG000|Reported Event|Study Group|Participants received a single dose of JE-CV in Study JEC02 (NCT00735644)
10990021|NCT01002105|BG000|Baseline|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
10990022|NCT01002105|BG001|Baseline|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
10990023|NCT01002105|BG002|Baseline|Total|Total of all reporting groups
10990024|NCT01002105|FG000|Participant Flow|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
10990025|NCT01002105|FG001|Participant Flow|Placebo|Placebo, identical to baclofen was administered to the placebo group for 12 weeks
10990026|NCT01002105|OG000|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
10990027|NCT01002105|OG001|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
10990028|NCT01002105|OG000|Outcome|Baclofen|The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. Baclofen: Baclofen 50mg per day for 12 weeks
10990029|NCT01002105|OG000|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
10990030|NCT01002105|OG001|Outcome|Placebo|IThe placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations
10990031|NCT01002105|EG000|Reported Event|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
10990032|NCT01002105|EG001|Reported Event|Placebo|The placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
10990033|NCT01002118|BG000|Baseline|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
10990034|NCT01002118|FG000|Participant Flow|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
10990035|NCT01002118|OG000|Outcome|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
10990036|NCT01002118|EG000|Reported Event|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
10990037|NCT01002287|BG000|Baseline|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
10990038|NCT01002287|BG001|Baseline|Control|Good Surgical Technique Alone
10990039|NCT01002287|BG002|Baseline|Total|Total of all reporting groups
10990040|NCT01002287|FG000|Participant Flow|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
10990041|NCT01002287|FG001|Participant Flow|Control|Good Surgical Technique Alone
10990042|NCT01002287|OG000|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
10990043|NCT01002287|OG001|Outcome|Control|Good Surgical Technique Alone
10990044|NCT01002287|EG000|Reported Event|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
10990045|NCT01002287|EG001|Reported Event|Control|Good Surgical Technique Alone
10990046|NCT01002339|BG000|Baseline|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
10990047|NCT01002339|BG001|Baseline|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
10990048|NCT01002339|BG002|Baseline|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
10990049|NCT01002339|BG003|Baseline|Total|Total of all reporting groups
10990050|NCT01002339|FG000|Participant Flow|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
10990051|NCT01002339|FG001|Participant Flow|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
10990052|NCT01002339|FG002|Participant Flow|Cyclosporin A (CsA) With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
10990053|NCT01002339|OG000|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
10990054|NCT01002339|OG001|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
10990055|NCT01002339|OG002|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
10990056|NCT01002339|EG000|Reported Event|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
10990057|NCT01002339|EG001|Reported Event|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
10990058|NCT01002339|EG002|Reported Event|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
10990059|NCT01002456|BG000|Baseline|Level 1|site-specific information provided
10990060|NCT01002456|BG001|Baseline|Level 2|site- and patient-specific information provided
10990061|NCT01002456|BG002|Baseline|Total|Total of all reporting groups
10990062|NCT01002456|FG000|Participant Flow|Arm 1|"provide site-specific information~Level 1 (Provide site-specific information): provide site-specific information on non-adherence to guideline"
10990063|NCT01002456|FG001|Participant Flow|Arm 2|"provide site- and patient-specific information~Level 2 (Provide site- and patient-specific information): provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions"
10990064|NCT01002456|OG000|Outcome|Level 1|provide site-specific information
10990065|NCT01002456|OG001|Outcome|Level 2|provide site- and patient-specific information
10990066|NCT01002456|OG000|Outcome|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on nonadherence
10990067|NCT01002456|OG001|Outcome|Level 2:Provide Site- and Patient-specific Information|Level 2:provide site- and patient-specific information on nonadherence
10876194|NCT00441337|BG001|Baseline|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876195|NCT00441337|BG002|Baseline|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876196|NCT00441337|BG003|Baseline|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876197|NCT00441337|BG004|Baseline|Total|Total of all reporting groups
10876198|NCT00441337|FG000|Participant Flow|0.3 mg/kg Nivolumab|0.3 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876199|NCT00441337|FG001|Participant Flow|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876200|NCT00441337|FG002|Participant Flow|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876201|NCT00441337|FG003|Participant Flow|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876202|NCT00441337|OG000|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876203|NCT00441337|OG001|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876204|NCT00441337|OG002|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876205|NCT00441337|OG003|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10990068|NCT01002456|EG000|Reported Event|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on non-adherence
10990069|NCT01002456|EG001|Reported Event|Level 2: Provide Site- and Patient-specific Information|Level 2: provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
10990070|NCT01002482|BG000|Baseline|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
10990071|NCT01002482|BG001|Baseline|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
10990072|NCT01002482|BG002|Baseline|Total|Total of all reporting groups
10990073|NCT01002482|FG000|Participant Flow|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
10990074|NCT01002482|FG001|Participant Flow|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
10990075|NCT01002482|OG000|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
10990076|NCT01002482|OG001|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
10990077|NCT01002482|EG000|Reported Event|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
10990078|NCT01002482|EG001|Reported Event|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
10990079|NCT01002547|BG000|Baseline|Placebo|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone-placebo: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm and following the same up-titration. Placebo pills have the same characteristics as pills with active medication.~Vitamin E-placebo: Placebo of vitamin E will be given to arm 1."
10990080|NCT01002547|BG001|Baseline|Vitamin E|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone-placebo: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm and following the same up-titration. Placebo pills have the same characteristics as pills with active medication.~Vitamin E: All participants will receive vitamin E 400 IU orally twice daily."
10990081|NCT01002547|BG002|Baseline|Pioglitazone + Vitamin E|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Pioglitazone will be started on 30 mg/day, titrated to the maximal dose (45 mg/day) at two months and continued at this dose for the rest of the clinical trial.~Vitamin E: All participants will receive vitamin E 400 IU orally twice daily."
10990082|NCT01002547|BG003|Baseline|Total|Total of all reporting groups
10990083|NCT01002547|FG000|Participant Flow|Placebo|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone-placebo: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm and following the same up-titration. Placebo pills have the same characteristics as pills with active medication.~Vitamin E-placebo: Placebo of vitamin E will be given to arm 1."
10990084|NCT01002547|FG001|Participant Flow|Vitamin E|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone-placebo: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm and following the same up-titration. Placebo pills have the same characteristics as pills with active medication.~Vitamin E: All participants will receive vitamin E 400 IU orally twice daily."
10990085|NCT01002547|FG002|Participant Flow|Pioglitazone + Vitamin E|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Pioglitazone will be started on 30 mg/day, titrated to the maximal dose (45 mg/day) at two months and continued at this dose for the rest of the clinical trial.~Vitamin E: All participants will receive vitamin E 400 IU orally twice daily."
10990086|NCT01002547|OG000|Outcome|Placebo|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone-placebo: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm and following the same up-titration. Placebo pills have the same characteristics as pills with active medication.~Vitamin E-placebo: Placebo of vitamin E will be given to arm 1."
10990087|NCT01002547|OG001|Outcome|Vitamin E|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone-placebo: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm and following the same up-titration. Placebo pills have the same characteristics as pills with active medication.~Vitamin E: All participants will receive vitamin E 400 IU orally twice daily."
10990088|NCT01002547|OG002|Outcome|Pioglitazone + Vitamin E|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Pioglitazone will be started on 30 mg/day, titrated to the maximal dose (45 mg/day) at two months and continued at this dose for the rest of the clinical trial.~Vitamin E: All participants will receive vitamin E 400 IU orally twice daily."
10990089|NCT01002547|EG000|Reported Event|Placebo|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone-placebo: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm and following the same up-titration. Placebo pills have the same characteristics as pills with active medication.~Vitamin E-placebo: Placebo of vitamin E will be given to arm 1."
11007357|NCT01090427|BG001|Baseline|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
10876206|NCT00441337|OG000|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10876207|NCT00441337|OG001|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10876208|NCT00441337|OG002|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10876209|NCT00441337|OG003|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10876210|NCT00441337|OG000|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10876211|NCT00441337|OG000|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10876212|NCT00441337|OG001|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10876213|NCT00441337|OG002|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10876214|NCT00441337|EG000|Reported Event|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876215|NCT00441337|EG001|Reported Event|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876216|NCT00441337|EG002|Reported Event|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
11007358|NCT01090427|BG002|Baseline|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
11007359|NCT01090427|BG003|Baseline|Total|Total of all reporting groups
11007360|NCT01090427|FG000|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
10876217|NCT00441337|EG003|Reported Event|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10876218|NCT00441350|BG000|Baseline|OM 40|"Olmesartanmedoxomil (OM)40 mg tablets.~OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks."
10876219|NCT00441350|BG001|Baseline|OM/HCTZ 40/12.5|"Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.~OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks."
10876220|NCT00441350|BG002|Baseline|Total|Total of all reporting groups
10876221|NCT00441350|FG000|Participant Flow|Phase A/OM 40|Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.
10876222|NCT00441350|FG001|Participant Flow|Phase A/OM/HCTZ 40/12.5|Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.
10876223|NCT00441350|FG002|Participant Flow|Phase B/ OM 40 mg Responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Responders to OM 40 mg treatment were to continue treatment with OM 40 mg."
10876224|NCT00441350|FG003|Participant Flow|Phase B/ OM 40 mg Non-responder|"Phase B (second double-blind treatment phase, 8 weeks duration):~Non-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg."
10876225|NCT00441350|FG004|Participant Flow|Phase B OM/HCTZ 40/12.5 mg Responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg."
10876226|NCT00441350|FG005|Participant Flow|Phase B/ OM/HCTZ 40/12.5 mg Non-responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg."
10876227|NCT00441350|OG000|Outcome|OM 40|Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks.
10876228|NCT00441350|OG001|Outcome|OM/HCTZ 40/12.5|Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks.
10876229|NCT00441350|OG000|Outcome|OM 40 mg Responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Responders to OM 40 mg treatment were to continue treatment with OM 40 mg."
10876230|NCT00441350|OG001|Outcome|OM 40 mg Non-responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Non-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg."
10876231|NCT00441350|OG002|Outcome|OM/HCTZ 40/12.5 mg Responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg."
10876232|NCT00441350|OG003|Outcome|OM/HCTZ 40/12.5 mg Non-responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg."
10876233|NCT00441350|EG000|Reported Event|Phase B OM/HCTZ 40/12.5 mg Non-responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg."
10876234|NCT00441350|EG001|Reported Event|Phase B OM/HCTZ 40/12.5 mg Responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg."
10876235|NCT00441350|EG002|Reported Event|Phase B OM 40 mg Non-responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Non-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg."
10876236|NCT00441350|EG003|Reported Event|Phase B OM 40 mg Responders|"Phase B (second double-blind treatment phase, 8 weeks duration):~Responders to OM 40 mg treatment were to continue treatment with OM 40 mg."
10876237|NCT00441350|EG004|Reported Event|Phase A OM/HCTZ 40/12.5 mg|"Phase A (first double-blind treatment phase, 8 weeks duration):~Arm 2: OM/HCTZ 40/12.5 mg tablet o.d."
10876238|NCT00441350|EG005|Reported Event|Phase A OM 40 mg|"Phase A (first double-blind treatment phase, 8 weeks duration):~Arm 1: OM 40 mg tablet o.d."
10876239|NCT00441363|BG000|Baseline|Cycloset|0.8 mg tablet
10876240|NCT00441363|BG001|Baseline|Placebo|matching placebo
10876241|NCT00441363|BG002|Baseline|Total|Total of all reporting groups
10876242|NCT00441363|FG000|Participant Flow|Cycloset|0.8 mg tablet
10876243|NCT00441363|FG001|Participant Flow|Placebo|matching placebo
10876244|NCT00441363|OG000|Outcome|Cycloset|0.8 mg tablet
10876245|NCT00441363|OG001|Outcome|Placebo|matching placebo
10876246|NCT00441363|EG000|Reported Event|Cycloset|0.8 mg tablet
10876247|NCT00441363|EG001|Reported Event|Placebo|matching placebo
10876248|NCT00441441|BG000|Baseline|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
10876249|NCT00441441|BG001|Baseline|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
10876250|NCT00441441|BG002|Baseline|Total|Total of all reporting groups
10876251|NCT00441441|FG000|Participant Flow|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
10876252|NCT00441441|FG001|Participant Flow|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
10876253|NCT00441441|OG000|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
10876254|NCT00441441|OG001|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
10876255|NCT00441441|OG000|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
10876256|NCT00441441|OG001|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone propionate 100 µg HFA (2inhalations of 50 µg), twice daily for 12 weeks.
10876257|NCT00441441|OG000|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
10876258|NCT00441441|OG000|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
10876259|NCT00441441|OG001|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
10876260|NCT00441441|OG002|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
10876261|NCT00441441|OG003|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
10876262|NCT00441441|OG000|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
10876263|NCT00441441|OG000|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
10876264|NCT00441441|OG001|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
10876265|NCT00441441|OG000|Outcome|No Spacer|Participants who did not use spacer and were in either treatment group
10876266|NCT00441441|OG001|Outcome|Spacer|Participants who required a spacer and were in either treatment group
10876267|NCT00441441|OG000|Outcome|Spacer|Participants who did not use spacer and were in either treatment group
10876268|NCT00441441|OG001|Outcome|No Spacer|Participants who required a spacer and were in either treatment group
10876269|NCT00441441|EG000|Reported Event|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
10876270|NCT00441441|EG001|Reported Event|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
10876271|NCT00441467|BG000|Baseline|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
10876272|NCT00441467|FG000|Participant Flow|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
10876273|NCT00441467|OG000|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
10876274|NCT00441467|EG000|Reported Event|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
10876275|NCT00441480|BG000|Baseline|PS-FO|plant sterols esterified to fish oil fatty acids
10876276|NCT00441480|BG001|Baseline|Control|Corn oil
10876277|NCT00441480|BG002|Baseline|Total|Total of all reporting groups
10876278|NCT00441480|FG000|Participant Flow|PS-FO|plant sterols esterified to fish oil fatty acids
10876279|NCT00441480|FG001|Participant Flow|Control|Corn oil
10876280|NCT00441480|OG000|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
10876281|NCT00441480|OG001|Outcome|Control|Corn oil
10876282|NCT00441480|EG000|Reported Event|PS-FO|plant sterols esterified to fish oil fatty acids
10876283|NCT00441480|EG001|Reported Event|Control|Corn oil
10876284|NCT00441545|BG000|Baseline|Entire Study Population|
10876285|NCT00441545|FG000|Participant Flow|Fosrenol First|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
10876286|NCT00441545|FG001|Participant Flow|Sevelamer HCl First|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
10876287|NCT00441545|OG000|Outcome|Fosrenol|Lanthanum carbonate
10876288|NCT00441545|OG001|Outcome|Sevelamer HCl|
10990090|NCT01002547|EG001|Reported Event|Vitamin E|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone-placebo: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm and following the same up-titration. Placebo pills have the same characteristics as pills with active medication.~Vitamin E: All participants will receive vitamin E 400 IU orally twice daily."
10990091|NCT01002547|EG002|Reported Event|Pioglitazone + Vitamin E|"Patients with T2DM and biopsy-proven NASH.~Pioglitazone: This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Pioglitazone will be started on 30 mg/day, titrated to the maximal dose (45 mg/day) at two months and continued at this dose for the rest of the clinical trial.~Vitamin E: All participants will receive vitamin E 400 IU orally twice daily."
10990092|NCT01002573|BG000|Baseline|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
10990093|NCT01002573|BG001|Baseline|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
10990094|NCT01002573|BG002|Baseline|Total|Total of all reporting groups
10990095|NCT01002573|FG000|Participant Flow|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
10990096|NCT01002573|FG001|Participant Flow|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
10990097|NCT01002573|OG000|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
10990098|NCT01002573|OG001|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
10990099|NCT01002573|EG000|Reported Event|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
10990100|NCT01002573|EG001|Reported Event|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
10990101|NCT01002742|BG000|Baseline|Placebo|Corticosteroids with placebo
10990102|NCT01002742|BG001|Baseline|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
10990103|NCT01002742|BG002|Baseline|Total|Total of all reporting groups
10990104|NCT01002742|FG000|Participant Flow|Placebo|Corticosteroids with placebo
10990105|NCT01002742|FG001|Participant Flow|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
10990106|NCT01002742|OG000|Outcome|Placebo|Corticosteroids with placebo
10990107|NCT01002742|OG001|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
10990108|NCT01002742|EG000|Reported Event|Placebo|Corticosteroids with placebo
10990109|NCT01002742|EG001|Reported Event|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
10990110|NCT01002755|BG000|Baseline|Treatment (Lenalidomide, Ofatumumab)|"Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Ofatumumab: Given IV"
10990111|NCT01002755|FG000|Participant Flow|Treatment (Lenalidomide, Ofatumumab)|"Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Ofatumumab: Given IV"
10990112|NCT01002755|OG000|Outcome|Treatment (Lenalidomide, Ofatumumab)|"Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Ofatumumab: Given IV"
10990113|NCT01002755|EG000|Reported Event|Treatment (Lenalidomide, Ofatumumab)|"Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Ofatumumab: Given IV"
10990114|NCT01002989|BG000|Baseline|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
10990115|NCT01002989|FG000|Participant Flow|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
10990116|NCT01002989|OG000|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
10990117|NCT01002989|EG000|Reported Event|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
10990118|NCT01003067|BG000|Baseline|No Mesh|The closure technique consisted of a single-layer continuous suture technique with picking up all layers of the abdominal wall apart from subcutaneous fat and skin (peritoneum, posterior rectus sheath, rectus muscle and anterior rectus sheath).
10990119|NCT01003067|BG001|Baseline|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
10990120|NCT01003067|BG002|Baseline|Total|Total of all reporting groups
10990121|NCT01003067|FG000|Participant Flow|No Mesh|conventional abdominal closure with a suture
10990122|NCT01003067|FG001|Participant Flow|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
10990123|NCT01003067|OG000|Outcome|No Mesh|conventional abdominal closure with a suture
10990124|NCT01003067|OG001|Outcome|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
10990125|NCT01003067|EG000|Reported Event|No Mesh|conventional abdominal closure with a suture
10990126|NCT01003067|EG001|Reported Event|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
10990127|NCT01003080|BG000|Baseline|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
10990128|NCT01003080|BG001|Baseline|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
10990129|NCT01003080|BG002|Baseline|Total|Total of all reporting groups
10990130|NCT01003080|FG000|Participant Flow|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
10990131|NCT01003080|FG001|Participant Flow|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
10990132|NCT01003080|OG000|Outcome|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
10990133|NCT01003080|OG001|Outcome|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
10990134|NCT01003080|EG000|Reported Event|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
10990135|NCT01003080|EG001|Reported Event|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
10990136|NCT01003106|BG000|Baseline|BRVO- Ranibizumab 0.5mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.~BRVO -Ranibizumab 0.5mg alone: Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
10990137|NCT01003106|BG001|Baseline|BRVO- Ranibizumab 2.0mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.~BRVO- Ranibizumab 2.0 mg alone: Branch retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
10990138|NCT01003106|BG002|Baseline|CRVO- Ranibizumab 0.5mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation~CRVO -Ranibizumab 0.5mg alone: Central retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
10990139|NCT01003106|BG003|Baseline|CRVO- Ranibizumab 2.0mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.~CRVO- Ranibizumab 2.0 mg alone: Central retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
10990140|NCT01003106|BG004|Baseline|Total|Total of all reporting groups
10990141|NCT01003106|FG000|Participant Flow|BRVO- Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg of ranibizumab alone for 6 months.
10990142|NCT01003106|FG001|Participant Flow|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 2.0mg of Ranibizumab alone for 6 months.
10990143|NCT01003106|FG002|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata 0.5mg/2.0mg of ranibizumab without laser photocoagulation.
10990144|NCT01003106|FG003|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) ranibizumab along with laser photocoagulation.
10990145|NCT01003106|FG004|Participant Flow|CRVO- Ranibizumab 0.5mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg at of ranibizumab alone for 6 months.
10990146|NCT01003106|FG005|Participant Flow|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive ranibizumab 2.0mg alone for 6 months .
10990147|NCT01003106|FG006|Participant Flow|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
10990148|NCT01003106|FG007|Participant Flow|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients randomized to this group at month 6 will receive 0.5mg/2.0mg prn ranibizumab along with laser photocoagulation.
10990149|NCT01003106|OG000|Outcome|BRVO|Patients with Branch Retinal Vein Occlusion
10990150|NCT01003106|OG001|Outcome|CRVO|Patients with Central Retinal Vein Occlusion
10990151|NCT01003106|OG000|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
10990152|NCT01003106|OG001|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
10990153|NCT01003106|OG002|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
10990154|NCT01003106|OG003|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
10990155|NCT01003106|OG000|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
10990156|NCT01003106|OG001|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
10990157|NCT01003106|OG002|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
10990158|NCT01003106|OG003|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
10990159|NCT01003106|EG000|Reported Event|BRVO|Patients with Branch Retinal Vein Occlusion
10990160|NCT01003106|EG001|Reported Event|CRVO|Patients with Central Retinal Vein Occlusion
10990161|NCT01003184|BG000|Baseline|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
10990162|NCT01003184|BG001|Baseline|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
10990163|NCT01003184|BG002|Baseline|Total|Total of all reporting groups
10990164|NCT01003184|FG000|Participant Flow|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
10990165|NCT01003184|FG001|Participant Flow|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
10990166|NCT01003184|OG000|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
10990167|NCT01003184|OG001|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
10990168|NCT01003184|EG000|Reported Event|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
10990169|NCT01003184|EG001|Reported Event|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
10990170|NCT01003210|BG000|Baseline|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
10990171|NCT01003210|BG001|Baseline|Standard Therapy|standard therapy for otitis media, no ear drops
10990172|NCT01003210|BG002|Baseline|Total|Total of all reporting groups
10990173|NCT01003210|FG000|Participant Flow|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
10990174|NCT01003210|FG001|Participant Flow|Standard Therapy|standard therapy for otitis media, no ear drops
10990175|NCT01003210|OG000|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
10990176|NCT01003210|OG001|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
10990177|NCT01003210|EG000|Reported Event|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
10990178|NCT01003210|EG001|Reported Event|Standard Therapy|standard therapy for otitis media, no ear drops
10990179|NCT01003249|BG000|Baseline|All Participants|Includes all participants in the study. Participants were randomized to either study drug or placebo
10990180|NCT01003249|FG000|Participant Flow|Baclofen, Then Placebo|Participants first received Baclofen for a total of 2 weeks (beginning dose=10mg and dose escalated up to 80 mg as symptoms appear), and were then tapered off of Baclofen for 2 weeks (total time= 4 weeks). This was followed by a 3 week washout period and then 4 weeks of Placebo.
10990181|NCT01003249|FG001|Participant Flow|Placebo, Then Baclofen|Participants received Placebo for 4 weeks, followed by a 3 week washout period. Participants then received Baclofen for a total of 2 weeks (beginning dose=10mg and dose escalated up to 80 mg as symptoms appear), and were then tapered off of Baclofen for 2 weeks (total time= 4 weeks).
10990182|NCT01003249|OG000|Outcome|Baclofen|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).~Baclofen: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)."
10990183|NCT01003249|OG001|Outcome|Placebo|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).~Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)."
10990184|NCT01003249|OG000|Outcome|Baclofen|Baclofen: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
10990185|NCT01003249|OG001|Outcome|Placebo|Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
10990186|NCT01003249|OG000|Outcome|Baclofen|Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
10990187|NCT01003249|OG001|Outcome|Placebo|Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)
10990188|NCT01003249|EG000|Reported Event|Baclofen|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).~Baclofen: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)."
10990189|NCT01003249|EG001|Reported Event|Placebo|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).~Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)."
10990190|NCT01003275|BG000|Baseline|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
10990191|NCT01003275|BG001|Baseline|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
10990192|NCT01003275|BG002|Baseline|Total|Total of all reporting groups
10990193|NCT01003275|FG000|Participant Flow|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
10990194|NCT01003275|FG001|Participant Flow|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
10990195|NCT01003275|OG000|Outcome|During Paricalcitol Treatment|
10990196|NCT01003275|OG001|Outcome|During Placebo Treatment|
10990197|NCT01003275|EG000|Reported Event|During/After Paricalcitol|
10990198|NCT01003275|EG001|Reported Event|During/After Placebo|
10990199|NCT01003288|BG000|Baseline|Health Care Workers|Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional
10990200|NCT01003288|BG001|Baseline|Hypogammaglobulinaemic Patients|Received two doses of pandemic vaccine
10990201|NCT01003288|BG002|Baseline|Total|Total of all reporting groups
10990202|NCT01003288|FG000|Participant Flow|Pandemic Influenza Vaccine (H1N1)v|"Pandemrix: Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A)~* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)"
10990203|NCT01003288|OG000|Outcome|Pandemic Vaccine|Pandemic Vaccine in HCW
10990204|NCT01003288|OG000|Outcome|HCW Pandemic Vaccine|
10990205|NCT01003288|EG000|Reported Event|Pandemic Vaccine|HCW vaccinated with pandemic vaccine
10990206|NCT01003301|BG000|Baseline|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
10990207|NCT01003301|BG001|Baseline|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
10990208|NCT01003301|BG002|Baseline|Total|Total of all reporting groups
10990209|NCT01003301|FG000|Participant Flow|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
10990210|NCT01003301|FG001|Participant Flow|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
10990211|NCT01003301|OG000|Outcome|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
10990212|NCT01003301|OG001|Outcome|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
10990213|NCT01003301|EG000|Reported Event|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
10990214|NCT01003301|EG001|Reported Event|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
10990215|NCT01003418|BG000|Baseline|GSK2340272A Group 1|Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.
10990216|NCT01003418|BG001|Baseline|GSK2340272A Group 2|Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.
10990217|NCT01003418|BG002|Baseline|Total|Total of all reporting groups
10990218|NCT01003418|FG000|Participant Flow|GSK2340272A Group 1|Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.
10990219|NCT01003418|FG001|Participant Flow|GSK2340272A Group 2|Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.
10990220|NCT01003418|OG000|Outcome|GSK2340272A Group 1|Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.
10990221|NCT01003418|OG001|Outcome|GSK2340272A Group 2|Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.
10990222|NCT01003418|EG000|Reported Event|GSK2340272A Group 1|Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.
10990223|NCT01003418|EG001|Reported Event|GSK2340272A Group 2|Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.
10990224|NCT01003639|BG000|Baseline|Acetazolamide|"Acetazolamide given in escalating doses~Acetazolamide: Subjects will begin with four 250 mg tablets daily."
10990225|NCT01003639|BG001|Baseline|Sugar Pill|"Given in escalating dose (number of pill)~Placebo: Subjects will begin with four tablets daily."
10990226|NCT01003639|BG002|Baseline|Total|Total of all reporting groups
10990227|NCT01003639|FG000|Participant Flow|Acetazolamide|"Acetazolamide given in escalating doses~Acetazolamide: Subjects will begin with four 250 mg tablets daily."
10990228|NCT01003639|FG001|Participant Flow|Sugar Pill|"Given in escalating dose (number of pill)~Placebo: Subjects will begin with four tablets daily."
10990229|NCT01003639|OG000|Outcome|Acetazolamide|"Acetazolamide given in escalating doses~Acetazolamide: Subjects will begin with four 250 mg tablets daily."
10990230|NCT01003639|OG001|Outcome|Sugar Pill|"Given in escalating dose (number of pill)~Placebo: Subjects will begin with four tablets daily."
10990231|NCT01003639|EG000|Reported Event|Acetazolamide|"Acetazolamide given in escalating doses~Acetazolamide: Subjects will begin with four 250 mg tablets daily."
10990232|NCT01003639|EG001|Reported Event|Sugar Pill|"Given in escalating dose (number of pill)~Placebo: Subjects will begin with four tablets daily."
10990233|NCT01003769|BG000|Baseline|Dose Level 1 (Lenalidomide in Combination With AT-101)|Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
10990234|NCT01003769|FG000|Participant Flow|Dose Level 1 (Lenalidomide in Combination With AT-101)|Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
10990235|NCT01003769|OG000|Outcome|Dose Level 1 (Lenalidomide in Combination With AT-101)|Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
10990236|NCT01003769|EG000|Reported Event|Dose Level 1 (Lenalidomide in Combination With AT-101)|Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
10990237|NCT01003886|BG000|Baseline|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
10990238|NCT01003886|FG000|Participant Flow|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
10990239|NCT01003886|OG000|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
10990240|NCT01003886|EG000|Reported Event|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
10990241|NCT01003899|BG000|Baseline|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
10990242|NCT01003899|FG000|Participant Flow|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
10990243|NCT01003899|OG000|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
10990244|NCT01003899|EG000|Reported Event|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
10990245|NCT01003938|BG000|Baseline|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
10990246|NCT01003938|FG000|Participant Flow|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
10990247|NCT01003938|OG000|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
10990248|NCT01003938|EG000|Reported Event|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
10990249|NCT01003990|BG000|Baseline|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
10990250|NCT01003990|BG001|Baseline|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
10990251|NCT01003990|BG002|Baseline|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
10990252|NCT01003990|BG003|Baseline|Total|Total of all reporting groups
10990253|NCT01003990|FG000|Participant Flow|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
10990254|NCT01003990|FG001|Participant Flow|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
10990255|NCT01003990|FG002|Participant Flow|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
10990256|NCT01003990|OG000|Outcome|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
10990257|NCT01003990|OG001|Outcome|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
10990258|NCT01003990|OG002|Outcome|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
10990259|NCT01003990|EG000|Reported Event|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
10990260|NCT01003990|EG001|Reported Event|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD; Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
10990261|NCT01003990|EG002|Reported Event|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID; Ritonavir: 100 mg BID; Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
10990262|NCT01004003|BG000|Baseline|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
10990263|NCT01004003|BG001|Baseline|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990264|NCT01004003|BG002|Baseline|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990265|NCT01004003|BG003|Baseline|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990266|NCT01004003|BG004|Baseline|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990267|NCT01004003|BG005|Baseline|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990268|NCT01004003|BG006|Baseline|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990269|NCT01004003|BG007|Baseline|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990270|NCT01004003|BG008|Baseline|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990271|NCT01004003|BG009|Baseline|Total|Total of all reporting groups
10990272|NCT01004003|FG000|Participant Flow|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
10990273|NCT01004003|FG001|Participant Flow|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990274|NCT01004003|FG002|Participant Flow|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990275|NCT01004003|FG003|Participant Flow|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990276|NCT01004003|FG004|Participant Flow|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990277|NCT01004003|FG005|Participant Flow|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990278|NCT01004003|FG006|Participant Flow|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990279|NCT01004003|FG007|Participant Flow|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990280|NCT01004003|FG008|Participant Flow|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990281|NCT01004003|OG000|Outcome|Group 1|Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
10990282|NCT01004003|OG001|Outcome|Group 2|Patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990283|NCT01004003|OG000|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990284|NCT01004003|OG001|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990285|NCT01004003|OG000|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD).~Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN)."
10990286|NCT01004003|OG001|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
10990287|NCT01004003|OG002|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
10990288|NCT01004003|OG003|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
10990289|NCT01004003|OG004|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
10990290|NCT01004003|OG005|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
10990291|NCT01004003|OG006|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
10990292|NCT01004003|EG000|Reported Event|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
10990293|NCT01004003|EG001|Reported Event|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990294|NCT01004003|EG002|Reported Event|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990295|NCT01004003|EG003|Reported Event|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990296|NCT01004003|EG004|Reported Event|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990297|NCT01004003|EG005|Reported Event|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990298|NCT01004003|EG006|Reported Event|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
10990299|NCT01004003|EG007|Reported Event|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990300|NCT01004003|EG008|Reported Event|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
10990301|NCT01004042|BG000|Baseline|Depressed Subjects|"Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.~Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment."
10990302|NCT01004042|BG001|Baseline|Non Depressed Subjects|"Subjects with no diagnosis of depression~Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment."
10990303|NCT01004042|BG002|Baseline|Total|Total of all reporting groups
10990304|NCT01004042|FG000|Participant Flow|Depressed Subjects|"Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.~Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment."
10990305|NCT01004042|FG001|Participant Flow|Non Depressed Subjects|"Subjects with no diagnosis of depression~Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment."
10990306|NCT01004042|OG000|Outcome|Depressed Subjects|"Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.~Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment."
10990307|NCT01004042|OG001|Outcome|Non Depressed Subjects|"Subjects with no diagnosis of depression~Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment."
10990308|NCT01004042|EG000|Reported Event|Depressed Subjects|"Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.~Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment."
10990309|NCT01004042|EG001|Reported Event|Non Depressed Subjects|"Subjects with no diagnosis of depression~Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment."
10990310|NCT01004107|BG000|Baseline|Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990311|NCT01004107|BG001|Baseline|Delayed Treatment|Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months
10990312|NCT01004107|BG002|Baseline|Total|Total of all reporting groups
10990313|NCT01004107|FG000|Participant Flow|Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990314|NCT01004107|FG001|Participant Flow|Delayed Treatment|Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months
10990315|NCT01004107|OG000|Outcome|Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990316|NCT01004107|OG001|Outcome|Delayed Treatment|Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
10990317|NCT01004107|OG001|Outcome|Delayed Treatment|"Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990318|NCT01004107|OG000|Outcome|Baseline: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990319|NCT01004107|OG001|Outcome|3 Months Post-treatment: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990320|NCT01004107|OG002|Outcome|6 Months Post-treatment: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990321|NCT01004107|OG003|Outcome|9 Months Post-treatment: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990322|NCT01004107|OG004|Outcome|12 Months Post-treatment: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990323|NCT01004107|OG000|Outcome|3 Months Post-treatment: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990324|NCT01004107|OG001|Outcome|6 Months Post-treatment: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990325|NCT01004107|OG002|Outcome|9 Months Post-treatment: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990326|NCT01004107|OG003|Outcome|12 Months Post-treatment: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990327|NCT01004107|OG000|Outcome|Baseline, Right Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990328|NCT01004107|OG001|Outcome|3 Months, Right Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990329|NCT01004107|OG002|Outcome|6 Months, Right Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990330|NCT01004107|OG003|Outcome|9 Months, Right Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990331|NCT01004107|OG004|Outcome|12 Months, Right Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990332|NCT01004107|OG005|Outcome|Baseline, Left Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990333|NCT01004107|OG006|Outcome|3 Months, Left Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990334|NCT01004107|OG007|Outcome|6 Months, Left Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990335|NCT01004107|OG008|Outcome|9 Months, Left Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990336|NCT01004107|OG009|Outcome|12 Months, Left Hand: Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990337|NCT01004107|EG000|Reported Event|Radiesse Injectable Dermal Filler|"Device: Radiesse Injectable Dermal Filler~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
10990338|NCT01004146|BG000|Baseline|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
10990339|NCT01004146|BG001|Baseline|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
10990340|NCT01004146|BG002|Baseline|Total|Total of all reporting groups
10990341|NCT01004146|FG000|Participant Flow|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
10990342|NCT01004146|FG001|Participant Flow|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
10990343|NCT01004146|OG000|Outcome|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
10990344|NCT01004146|OG001|Outcome|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
10990345|NCT01004146|EG000|Reported Event|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
10990346|NCT01004146|EG001|Reported Event|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
10990347|NCT01004159|BG000|Baseline|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
10990348|NCT01004159|FG000|Participant Flow|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
10990349|NCT01004159|OG000|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
10990350|NCT01004159|EG000|Reported Event|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
10990351|NCT01004172|BG000|Baseline|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle~bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle~trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants~HER-2: human epidermal growth factor receptor 2"
10990352|NCT01004172|FG000|Participant Flow|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle~bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle~trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants~HER-2: human epidermal growth factor receptor 2"
10990353|NCT01004172|OG000|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle~bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle~trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants~HER-2: human epidermal growth factor receptor 2"
10990354|NCT01004172|OG000|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle~bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle~trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1~HER-2: human epidermal growth factor receptor 2"
10990355|NCT01004172|EG000|Reported Event|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle~bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle~trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants~HER-2: human epidermal growth factor receptor 2"
10990356|NCT01004185|BG000|Baseline|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
10990357|NCT01004185|BG001|Baseline|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
10990358|NCT01004185|BG002|Baseline|Total|Total of all reporting groups
10990359|NCT01004185|FG000|Participant Flow|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
10990360|NCT01004185|FG001|Participant Flow|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
10990361|NCT01004185|OG000|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
10990362|NCT01004185|OG001|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
10990363|NCT01004185|EG000|Reported Event|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
10990364|NCT01004185|EG001|Reported Event|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
10990365|NCT01004250|BG000|Baseline|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
10990366|NCT01004250|FG000|Participant Flow|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
10990367|NCT01004250|OG000|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
10990368|NCT01004250|OG000|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
10990369|NCT01004250|OG000|Outcome|Study Treament|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
10990370|NCT01004250|EG000|Reported Event|Induction Therapy|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
10990371|NCT01004250|EG001|Reported Event|Maintenance Therapy|"Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
10990372|NCT01004250|EG002|Reported Event|Overall Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
10990373|NCT01004354|BG000|Baseline|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
10990374|NCT01004354|FG000|Participant Flow|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
10990375|NCT01004354|OG000|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
10990376|NCT01004354|EG000|Reported Event|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
10990377|NCT01004393|BG000|Baseline|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
10990378|NCT01004393|FG000|Participant Flow|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
10990379|NCT01004393|OG000|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
10990380|NCT01004393|EG000|Reported Event|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
11007361|NCT01090427|FG001|Participant Flow|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
11007362|NCT01090427|FG002|Participant Flow|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
11007363|NCT01090427|FG003|Participant Flow|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
11007364|NCT01090427|FG004|Participant Flow|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
11007365|NCT01090427|FG005|Participant Flow|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
11007366|NCT01090427|FG006|Participant Flow|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
11007367|NCT01090427|OG000|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
11007368|NCT01090427|OG001|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
11007369|NCT01090427|OG002|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
11007370|NCT01090427|EG000|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
11007371|NCT01090427|EG001|Reported Event|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
11007372|NCT01090427|EG002|Reported Event|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
11007373|NCT01090427|EG003|Reported Event|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
11007374|NCT01090427|EG004|Reported Event|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
11007375|NCT01090427|EG005|Reported Event|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
11007376|NCT01090427|EG006|Reported Event|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
11007377|NCT01090453|BG000|Baseline|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
11007378|NCT01090453|BG001|Baseline|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
11007379|NCT01090453|BG002|Baseline|Total|Total of all reporting groups
11007380|NCT01090453|FG000|Participant Flow|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
11007381|NCT01090453|FG001|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
10990381|NCT01004406|BG000|Baseline|Intensive LDL-lowering Therapy (ILLT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
10990382|NCT01004406|BG001|Baseline|Standard Statin Monotherapy (SMT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
10990383|NCT01004406|BG002|Baseline|Total|Total of all reporting groups
10990384|NCT01004406|FG000|Participant Flow|Intensive LDL-lowering Therapy (ILLT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
10990385|NCT01004406|FG001|Participant Flow|Standard Statin Monotherapy (SMT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
10990386|NCT01004406|OG000|Outcome|Intensive LDL-lowering Therapy (ILLT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
10990387|NCT01004406|OG001|Outcome|Standard Statin Monotherapy (SMT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
10990388|NCT01004406|EG000|Reported Event|Intensive LDL-lowering Therapy (ILLT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
10990389|NCT01004406|EG001|Reported Event|Standard Statin Monotherapy (SMT)|Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
10990390|NCT01004432|BG000|Baseline|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
10990391|NCT01004432|FG000|Participant Flow|Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
10990392|NCT01004432|FG001|Participant Flow|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
10990393|NCT01004432|FG002|Participant Flow|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
10990394|NCT01004432|FG003|Participant Flow|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
10990395|NCT01004432|FG004|Participant Flow|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
10990396|NCT01004432|OG000|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
10990397|NCT01004432|OG000|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
10990398|NCT01004432|OG000|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
10990399|NCT01004432|OG001|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
10990400|NCT01004432|OG001|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
10990401|NCT01004432|OG002|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
10990402|NCT01004432|OG003|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
10990403|NCT01004432|EG000|Reported Event|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
10990404|NCT01004432|EG001|Reported Event|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
10990405|NCT01004432|EG002|Reported Event|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
10990406|NCT01004432|EG003|Reported Event|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
10990407|NCT01004432|EG004|Reported Event|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
10990408|NCT01004614|BG000|Baseline|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during the second intervention period. A washout of 14 days was retained between periods.
10990409|NCT01004614|BG001|Baseline|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
10990410|NCT01004614|BG002|Baseline|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
10990411|NCT01004614|BG003|Baseline|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
10990412|NCT01004614|BG004|Baseline|Total|Total of all reporting groups
10990413|NCT01004614|FG000|Participant Flow|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods.
10990414|NCT01004614|FG001|Participant Flow|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
10990415|NCT01004614|FG002|Participant Flow|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
10990416|NCT01004614|FG003|Participant Flow|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
10990417|NCT01004614|OG000|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
10990418|NCT01004614|OG001|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
10990419|NCT01004614|OG002|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
10990420|NCT01004614|OG003|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
10990421|NCT01004614|EG000|Reported Event|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
10990422|NCT01004614|EG001|Reported Event|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
10990423|NCT01004614|EG002|Reported Event|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
10990424|NCT01004614|EG003|Reported Event|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
10990425|NCT01004705|BG000|Baseline|Randomized Patients|All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill)
10990426|NCT01004705|FG000|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
10990427|NCT01004705|FG001|Participant Flow|Combination Pill Then Simvastatin|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks
10990428|NCT01004705|FG002|Participant Flow|Simvastatin Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks.
10990429|NCT01004705|OG000|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
10990430|NCT01004705|OG001|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
10990431|NCT01004705|EG000|Reported Event|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
10990432|NCT01004705|EG001|Reported Event|Combination Pill|Combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks
10990433|NCT01004705|EG002|Reported Event|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
10990434|NCT01004718|BG000|Baseline|Fludeoxyglucose F18 (FDG) PET/CT Scans|"Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.~Fludeoxyglucose F18: Undergo FDG PET/CT scans~Computed Tomography: Undergo FDG PET/CT scans~Positron emission tomography: Undergo FDG PET/CT scans"
10990435|NCT01004718|FG000|Participant Flow|Fludeoxyglucose F18 (FDG) PET/CT Scans|"Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.~Fludeoxyglucose F18: Undergo FDG PET/CT scans~Computed Tomography: Undergo FDG PET/CT scans~Positron emission tomography: Undergo FDG PET/CT scans"
10990436|NCT01004718|OG000|Outcome|Diffuse Large B-cell Lymphoma|Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.
10990437|NCT01004718|OG001|Outcome|Hodgkin's Lymphoma|Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.
10990438|NCT01004718|EG000|Reported Event|Fludeoxyglucose F18 (FDG) PET/CT Scans|Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.
10990439|NCT01004744|BG000|Baseline|Presurgical Oral Anastrozole|"1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.~Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery"
10990440|NCT01004744|FG000|Participant Flow|Presurgical Oral Anastrozole|"1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.~Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery"
10990441|NCT01004744|OG000|Outcome|Presurgical Oral Anastrozole|"1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.~Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery"
10990442|NCT01004744|EG000|Reported Event|Presurgical Oral Anastrozole|"1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.~Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery"
10990443|NCT01004770|BG000|Baseline|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
10990444|NCT01004770|BG001|Baseline|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
10990445|NCT01004770|BG002|Baseline|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
10990446|NCT01004770|BG003|Baseline|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
10990447|NCT01004770|BG004|Baseline|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
10990448|NCT01004770|BG005|Baseline|Total|Total of all reporting groups
10990449|NCT01004770|FG000|Participant Flow|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
10990450|NCT01004770|FG001|Participant Flow|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
10990451|NCT01004770|FG002|Participant Flow|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
10990452|NCT01004770|FG003|Participant Flow|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
10990453|NCT01004770|FG004|Participant Flow|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
10990454|NCT01004770|OG000|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
10990455|NCT01004770|OG001|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
10990456|NCT01004770|OG002|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
10990457|NCT01004770|OG003|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
10990458|NCT01004770|OG004|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
10990459|NCT01004770|EG000|Reported Event|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
10990460|NCT01004770|EG001|Reported Event|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
10990461|NCT01004770|EG002|Reported Event|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
10990462|NCT01004770|EG003|Reported Event|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
10990463|NCT01004770|EG004|Reported Event|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
10990464|NCT01004822|BG000|Baseline|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990465|NCT01004822|BG001|Baseline|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990466|NCT01004822|BG002|Baseline|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990467|NCT01004822|BG003|Baseline|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990468|NCT01004822|BG004|Baseline|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990469|NCT01004822|BG005|Baseline|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990470|NCT01004822|BG006|Baseline|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990471|NCT01004822|BG007|Baseline|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990472|NCT01004822|BG008|Baseline|Total|Total of all reporting groups
10990473|NCT01004822|FG000|Participant Flow|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990474|NCT01004822|FG001|Participant Flow|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990475|NCT01004822|FG002|Participant Flow|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990476|NCT01004822|FG003|Participant Flow|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990477|NCT01004822|FG004|Participant Flow|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990478|NCT01004822|FG005|Participant Flow|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990479|NCT01004822|FG006|Participant Flow|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990480|NCT01004822|FG007|Participant Flow|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990481|NCT01004822|OG000|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990482|NCT01004822|OG000|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990483|NCT01004822|OG000|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990484|NCT01004822|OG001|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990485|NCT01004822|OG002|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990486|NCT01004822|OG003|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990487|NCT01004822|OG004|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990488|NCT01004822|OG005|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990489|NCT01004822|OG006|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990490|NCT01004822|OG007|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990491|NCT01004822|EG000|Reported Event|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990492|NCT01004822|EG001|Reported Event|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990493|NCT01004822|EG002|Reported Event|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990494|NCT01004822|EG003|Reported Event|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990495|NCT01004822|EG004|Reported Event|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990496|NCT01004822|EG005|Reported Event|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990497|NCT01004822|EG006|Reported Event|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990498|NCT01004822|EG007|Reported Event|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
10990499|NCT01004848|BG000|Baseline|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aimed to help participants lose weight, thereby preventing their progression to diabetes."
10990500|NCT01004848|BG001|Baseline|Delayed Intervention|The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
10990501|NCT01004848|BG002|Baseline|Total|Total of all reporting groups
10990502|NCT01004848|FG000|Participant Flow|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
10990503|NCT01004848|FG001|Participant Flow|Delayed Intervention|The control group was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
10990504|NCT01004848|OG000|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
10990505|NCT01004848|OG001|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
10990506|NCT01004848|OG000|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
10990507|NCT01004848|OG001|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
10990508|NCT01004848|EG000|Reported Event|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
10990509|NCT01004848|EG001|Reported Event|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
10990510|NCT01004939|BG000|Baseline|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
10990511|NCT01004939|FG000|Participant Flow|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
10990512|NCT01004939|OG000|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
10990513|NCT01004939|OG000|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
10990514|NCT01004939|EG000|Reported Event|Fondaparinux - Mother|Events reported for mothers receiving Fondaparinux
10990515|NCT01004939|EG001|Reported Event|Fondaparinux - Child|Events reported for children (including 4 twins) born to mothers receiving Fondaparinux
10990516|NCT01004991|BG000|Baseline|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
10990517|NCT01004991|FG000|Participant Flow|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
10990518|NCT01004991|OG000|Outcome|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
10990519|NCT01004991|EG000|Reported Event|All Patients|all study patients
10990520|NCT01005251|BG000|Baseline|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
10990521|NCT01005251|BG001|Baseline|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
10990522|NCT01005251|BG002|Baseline|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
10990523|NCT01005251|BG003|Baseline|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
10990524|NCT01005251|BG004|Baseline|Placebo|PPI+Placebo
10990525|NCT01005251|BG005|Baseline|Total|Total of all reporting groups
10990526|NCT01005251|FG000|Participant Flow|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
10990527|NCT01005251|FG001|Participant Flow|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
10990528|NCT01005251|FG002|Participant Flow|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
10990529|NCT01005251|FG003|Participant Flow|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
10990530|NCT01005251|FG004|Participant Flow|Placebo|PPI+Placebo
10990531|NCT01005251|OG000|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
10990532|NCT01005251|OG001|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
10990533|NCT01005251|OG002|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
10990534|NCT01005251|OG003|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
10990535|NCT01005251|OG004|Outcome|Placebo|PPI+Placebo
10990536|NCT01005251|EG000|Reported Event|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
10990537|NCT01005251|EG001|Reported Event|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
10990538|NCT01005251|EG002|Reported Event|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
10990539|NCT01005251|EG003|Reported Event|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
10990540|NCT01005251|EG004|Reported Event|Placebo|PPI+Placebo
10990541|NCT01005290|BG000|Baseline|Randomized Patiens|All patients who were randomized to both treatment sequences
10990542|NCT01005290|FG000|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg once daily
10990543|NCT01005290|FG001|Participant Flow|Combination Pill Then Ramipril|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks
10990544|NCT01005290|FG002|Participant Flow|Ramipril Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
10990545|NCT01005290|OG000|Outcome|Combination Pill|Difference in the adjusted mean 24-h systolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
10990546|NCT01005290|OG001|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
10990547|NCT01005290|OG000|Outcome|Combination Pill|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
10990548|NCT01005290|EG000|Reported Event|Combination Pill|
10990549|NCT01005290|EG001|Reported Event|Ramipril|
10990550|NCT01005316|BG000|Baseline|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990551|NCT01005316|BG001|Baseline|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990552|NCT01005316|BG002|Baseline|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990553|NCT01005316|BG003|Baseline|Total|Total of all reporting groups
10990554|NCT01005316|FG000|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did not receive a heart transplant as specified by the protocol.
10990555|NCT01005316|FG001|Participant Flow|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
11007382|NCT01090453|OG000|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
10990556|NCT01005316|FG002|Participant Flow|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990557|NCT01005316|FG003|Participant Flow|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990558|NCT01005316|OG000|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990559|NCT01005316|OG001|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990560|NCT01005316|OG002|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990561|NCT01005316|OG000|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction),
10990562|NCT01005316|OG000|Outcome|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did not receive a heart transplant as specified by the protocol.
10990563|NCT01005316|OG000|Outcome|Enrolled|Enrolled participants who died, were transplanted or de-listed.
10990564|NCT01005316|EG000|Reported Event|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990565|NCT01005316|EG001|Reported Event|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R))
11348209|NCT04204200|EG000|Reported Event|Allocated to Conventional Vitamin C (n= 22)|Participant intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery).
10990566|NCT01005316|EG002|Reported Event|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
10990567|NCT01005329|BG000|Baseline|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10990568|NCT01005329|FG000|Participant Flow|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10990569|NCT01005329|OG000|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10990570|NCT01005329|OG000|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10990571|NCT01005329|EG000|Reported Event|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10990572|NCT01005355|BG000|Baseline|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990573|NCT01005355|BG001|Baseline|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990574|NCT01005355|BG002|Baseline|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990575|NCT01005355|BG003|Baseline|Total|Total of all reporting groups
10990576|NCT01005355|FG000|Participant Flow|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990577|NCT01005355|FG001|Participant Flow|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990578|NCT01005355|FG002|Participant Flow|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990579|NCT01005355|OG000|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990580|NCT01005355|OG001|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990581|NCT01005355|OG002|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990582|NCT01005355|OG000|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990583|NCT01005355|OG000|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990584|NCT01005355|OG000|Outcome|IMC-1121B 10 mg/kg|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990585|NCT01005355|EG000|Reported Event|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990586|NCT01005355|EG001|Reported Event|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990587|NCT01005355|EG002|Reported Event|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
10990588|NCT01005407|BG000|Baseline|HEPLISAV and Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
10990589|NCT01005407|BG001|Baseline|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24"
10990590|NCT01005407|BG002|Baseline|Total|Total of all reporting groups
10990591|NCT01005407|FG000|Participant Flow|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
10990592|NCT01005407|FG001|Participant Flow|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
10990593|NCT01005407|OG000|Outcome|HEPLISAV and Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
10990594|NCT01005407|OG001|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24"
10990595|NCT01005407|EG000|Reported Event|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
10990596|NCT01005407|EG001|Reported Event|Engerix-B(1)|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24"
10990597|NCT01005459|BG000|Baseline|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
10990598|NCT01005459|BG001|Baseline|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
10990599|NCT01005459|BG002|Baseline|Total|Total of all reporting groups
10990600|NCT01005459|FG000|Participant Flow|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
10990601|NCT01005459|FG001|Participant Flow|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
10990602|NCT01005459|OG000|Outcome|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
10990603|NCT01005459|OG001|Outcome|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
10990604|NCT01005459|EG000|Reported Event|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
10990605|NCT01005459|EG001|Reported Event|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
10990606|NCT01005576|BG000|Baseline|Conditioning Regimen|"Hydroxyurea days -50 to -21 Alemtuzumab days -21 to -19 Fludarabine days -8 to -4 Thiotepa day -4 Melphalan day -3 Stem cell infusion day 0~Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan: Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
10990607|NCT01005576|FG000|Participant Flow|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
10990608|NCT01005576|OG000|Outcome|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
10990609|NCT01005576|EG000|Reported Event|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
10990610|NCT01005602|BG000|Baseline|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
10990611|NCT01005602|BG001|Baseline|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
10990612|NCT01005602|BG002|Baseline|Total|Total of all reporting groups
10990613|NCT01005602|FG000|Participant Flow|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
10990614|NCT01005602|FG001|Participant Flow|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
10990615|NCT01005602|OG000|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
10990616|NCT01005602|OG001|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
10990617|NCT01005602|OG000|Outcome|Wild Type|Genotypes for the ABCB1 single nucleotide polymorphism C1236T
10990618|NCT01005602|OG001|Outcome|CT Genotype|
10990619|NCT01005602|OG002|Outcome|TT Genotype|
10990620|NCT01005602|OG000|Outcome|Wild Type (CC)|
10990621|NCT01005602|OG000|Outcome|Wild Type (GG)|
10990622|NCT01005602|OG001|Outcome|GT Genotype|
10990623|NCT01005602|OG003|Outcome|GA Genotype|
10990624|NCT01005602|EG000|Reported Event|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
10990625|NCT01005602|EG001|Reported Event|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
10990626|NCT01005680|BG000|Baseline|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
10990627|NCT01005680|BG001|Baseline|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
10990628|NCT01005680|BG002|Baseline|Total|Total of all reporting groups
10990629|NCT01005680|FG000|Participant Flow|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
10990630|NCT01005680|FG001|Participant Flow|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
10990631|NCT01005680|OG000|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
10990632|NCT01005680|OG001|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
10990633|NCT01005680|OG001|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
10990634|NCT01005680|EG000|Reported Event|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
10990635|NCT01005680|EG001|Reported Event|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
10990636|NCT01005706|BG000|Baseline|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
10990637|NCT01005706|BG001|Baseline|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
10990638|NCT01005706|BG002|Baseline|Total|Total of all reporting groups
10990639|NCT01005706|FG000|Participant Flow|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
10990640|NCT01005706|FG001|Participant Flow|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
10990641|NCT01005706|OG000|Outcome|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
10990642|NCT01005706|OG001|Outcome|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
10990643|NCT01005706|EG000|Reported Event|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
10990644|NCT01005706|EG001|Reported Event|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
10990645|NCT01005719|BG000|Baseline|Overall Study|
10990646|NCT01005719|FG000|Participant Flow|Zegerid-Prevacid®-No Treatment|Participants received Zegerid in Period 1, Prevacid® in Period 2 and No treatment in Period 3.
10990647|NCT01005719|FG001|Participant Flow|Zegerid-No Treatment-Prevacid®|Participants received Zegerid in Period 1, No treatment in Period 2 and Prevacid® in Period 3
10990648|NCT01005719|FG002|Participant Flow|Prevacid®-Zegerid-No Treatment|Participants received Prevacid® in Period 1, Zegerid in Period 2 and No treatment in Period 3
10990649|NCT01005719|FG003|Participant Flow|Prevacid®-No Treatment-Zegerid|Participants received Prevacid® in Period 1, No treatment in Period 2 and Zegerid in Period 3
10990650|NCT01005719|FG004|Participant Flow|No Treatment-Zegerid-Prevacid®|Participants received No treatment in Period 1, Zegerid in Period 2 and Prevacid® in Period 3
10990651|NCT01005719|FG005|Participant Flow|No Treatment-Prevacid®-Zegerid|Participants received No treatment in Period 1, Prevacid® in Period 2 and Zegerid in Period 3
10990652|NCT01005719|OG000|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
10990653|NCT01005719|OG001|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
10990654|NCT01005719|OG002|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
10990655|NCT01005719|OG001|Outcome|Prevacid®|"Participants receiving in Prevacid® Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
10990656|NCT01005719|EG000|Reported Event|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
10990657|NCT01005719|EG001|Reported Event|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
10990658|NCT01005719|EG002|Reported Event|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
10990659|NCT01005732|BG000|Baseline|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17-24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
10990660|NCT01005732|FG000|Participant Flow|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17-24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
10990661|NCT01005732|OG000|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
10990662|NCT01005732|OG001|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
10990663|NCT01005732|OG002|Outcome|Kneecap|Hardness of uninjured skin over a bony prominence is provided for comparison.
10990664|NCT01005732|OG003|Outcome|Uninjured Forearm Skin|Hardness of uninjured forearm skin is provided for comparison.
11348210|NCT04204200|EG001|Reported Event|Allocated to Liposomal Vitamin C (n= 22)|Participant intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days.
10990665|NCT01005732|OG000|Outcome|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17-24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
10990666|NCT01005732|EG000|Reported Event|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17-24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
10990667|NCT01005810|BG000|Baseline|N-Acetylcysteine|"N-Acetylcysteine : 1200 mg twice daily for 8 weeks~Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule"
10990668|NCT01005810|BG001|Baseline|Placebo|"placebo : 2 capsules twice daily for 8 weeks~Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule"
10990669|NCT01005810|BG002|Baseline|Total|Total of all reporting groups
10990670|NCT01005810|FG000|Participant Flow|N-Acetylcysteine|"N-Acetylcysteine : 1200 mg twice daily for 8 weeks~Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule"
10990671|NCT01005810|FG001|Participant Flow|Placebo|"placebo : 2 capsules twice daily for 8 weeks~Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule"
10990672|NCT01005810|OG000|Outcome|N-Acetylcysteine|"N-Acetylcysteine : 1200 mg twice daily for 8 weeks~Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule"
10990673|NCT01005810|OG001|Outcome|Placebo|"placebo : 2 capsules twice daily for 8 weeks~Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule"
10990674|NCT01005810|EG000|Reported Event|N-Acetylcysteine|"N-Acetylcysteine: 1200 mg twice daily for 8 weeks~Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule"
10990675|NCT01005810|EG001|Reported Event|Placebo|"placebo: 2 capsules twice daily for 8 weeks~Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule"
10990676|NCT01005875|BG000|Baseline|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
10990677|NCT01005875|FG000|Participant Flow|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
10990678|NCT01005875|OG000|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
10990679|NCT01005875|EG000|Reported Event|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
10990680|NCT01005888|BG000|Baseline|C1INH-nf First, Then Placebo|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
10990681|NCT01005888|BG001|Baseline|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
10990682|NCT01005888|BG002|Baseline|Open-label C1INH-nf Only|One subject received open-label C1INH-nf but withdrew prior to randomization.
10990683|NCT01005888|BG003|Baseline|Randomized, Not Treated|One subject was randomized but withdrew prior to receiving study drug.
10990684|NCT01005888|BG004|Baseline|Total|Total of all reporting groups
10990685|NCT01005888|FG000|Participant Flow|C1INH-nf First, Then Placebo|1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
10990686|NCT01005888|FG001|Participant Flow|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
10990687|NCT01005888|OG000|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
10990688|NCT01005888|OG001|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
10990689|NCT01005888|EG000|Reported Event|C1INH-nf|
10990690|NCT01005888|EG001|Reported Event|Placebo|
10990691|NCT01005901|BG000|Baseline|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
10990692|NCT01005901|BG001|Baseline|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
10990693|NCT01005901|BG002|Baseline|Total|Total of all reporting groups
10990694|NCT01005901|FG000|Participant Flow|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
10990695|NCT01005901|FG001|Participant Flow|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
10990696|NCT01005901|OG000|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
10990697|NCT01005901|OG001|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
10990698|NCT01005901|EG000|Reported Event|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
10990699|NCT01005901|EG001|Reported Event|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
10990700|NCT01005966|BG000|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments or who have been evaluated for AEs were included.
10990701|NCT01005966|FG000|Participant Flow|Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F]|Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF)
10990702|NCT01005966|FG001|Participant Flow|Amine Fluoride(AmF) Toothpaste (1400ppmF)|Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF)
10990703|NCT01005966|FG002|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF)
10990704|NCT01005966|FG003|Participant Flow|NaF Toothpaste (675ppmF)|Study toothpaste containing sodium fluoride and silica (675ppmF as NaF)
10990705|NCT01005966|FG004|Participant Flow|Placebo Toothpaste (0ppmF)|Placebo fluoride free toothpaste
10990706|NCT01005966|OG000|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
10990707|NCT01005966|OG001|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
10990708|NCT01005966|OG001|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF(1400ppmF)
10990709|NCT01005966|OG002|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF- 1000ppmF as NaMFP and 450ppmF as NaF)
10990710|NCT01005966|OG003|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/silica (675ppmF)
10990711|NCT01005966|OG004|Outcome|Placebo Toothpaste (0ppmF)|Placebo - fluoride free toothpaste
10990712|NCT01005966|OG002|Outcome|Na MFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF)
10990713|NCT01005966|OG003|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
10990714|NCT01005966|OG004|Outcome|Placebo Toothpaste (0ppmF)|Placebo: Fluoride free toothpaste
10990715|NCT01005966|EG000|Reported Event|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
10990716|NCT01005966|EG001|Reported Event|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
10990717|NCT01005966|EG002|Reported Event|NaMFP/ NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/ NaF (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF)
10990718|NCT01005966|EG003|Reported Event|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
10990719|NCT01005966|EG004|Reported Event|Placebo Toothpaste (0ppmF)|Placebo: fluoride free toothpaste
10990720|NCT01005966|EG005|Reported Event|Overall|
10990721|NCT01006122|BG000|Baseline|Entire Study|Included all participants randomized to receive PF-03654746 first and placebo first.
10990722|NCT01006122|FG000|Participant Flow|PF-03654746 First, Then Placebo|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
10990723|NCT01006122|FG001|Participant Flow|Placebo First Then, PF-03654746|Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.
10990724|NCT01006122|OG000|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
10990725|NCT01006122|OG001|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
10990726|NCT01006122|EG000|Reported Event|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
10990727|NCT01006122|EG001|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
10990728|NCT01006135|BG000|Baseline|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
10990729|NCT01006135|FG000|Participant Flow|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
10990730|NCT01006135|OG000|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
10990731|NCT01006135|EG000|Reported Event|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
10990732|NCT01006252|BG000|Baseline|Tasisulam-sodium|Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
10990733|NCT01006252|BG001|Baseline|Paclitaxel|Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
10990734|NCT01006252|BG002|Baseline|Total|Total of all reporting groups
10990735|NCT01006252|FG000|Participant Flow|Tasisulam-sodium|Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
10990736|NCT01006252|FG001|Participant Flow|Paclitaxel|Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
10990737|NCT01006252|OG000|Outcome|Tasisulam-sodium|Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
10990738|NCT01006252|OG001|Outcome|Paclitaxel|Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
10990739|NCT01006252|OG001|Outcome|Paclitaxel|Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
10990740|NCT01006252|OG000|Outcome|Tasisulam-sodium|Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle until disease progression.
10990741|NCT01006252|OG001|Outcome|Paclitaxel|Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle until disease progression.
10990742|NCT01006252|OG000|Outcome|Tasisulam|Dose was adjusted based on participant laboratory parameters and lean body weight; administered intravenously every 28 days until disease progression, or other criteria for participant discontinuation were met.
10990743|NCT01006252|EG000|Reported Event|Tasisulam-sodium|Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
10990744|NCT01006252|EG001|Reported Event|Paclitaxel|Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
10990745|NCT01006291|BG000|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
10990746|NCT01006291|BG001|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
10990747|NCT01006291|BG002|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
10990748|NCT01006291|BG003|Baseline|Total|Total of all reporting groups
10990749|NCT01006291|FG000|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
10990750|NCT01006291|FG001|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
10990751|NCT01006291|FG002|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
10990752|NCT01006291|OG000|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
10990753|NCT01006291|OG001|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
10990754|NCT01006291|OG002|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
10990755|NCT01006291|EG000|Reported Event|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
10990756|NCT01006291|EG001|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
10990757|NCT01006291|EG002|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
10990758|NCT01006356|BG000|Baseline|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
10990759|NCT01006356|FG000|Participant Flow|Hydromorphone Hydrochloride Oral Osmotic System|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
10990760|NCT01006356|OG000|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
10990761|NCT01006356|EG000|Reported Event|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
10990762|NCT01006369|BG000|Baseline|FOLFOX6 + Bevacizumab + Hydroxychloroquine|"bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one~Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days~hydroxychloroquine: hydroxychloroquine 200 mg po BID daily"
10990763|NCT01006369|BG001|Baseline|XELOX + Bevacizumab + Hydroxychloroquine|"bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one~Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days~XELOX regimen: Capecitabine will be started at a dose of 1,000 mg/m2/day bid po (total daily dose = 2,000 mg/m2) for 14 days (28 doses) of the 21 day cycle. This cycle will be repeated every 21 days. Oxaliplatin will be started at a dose of 130 mg/m2, in 250 ml of D5W over 2 hours given day 1 of each cycle. This cycle will be repeated every 21 days.~hydroxychloroquine: hydroxychloroquine 200 mg po BID daily"
10990764|NCT01006369|BG002|Baseline|Total|Total of all reporting groups
10990765|NCT01006369|FG000|Participant Flow|FOLFOX6 + Bevacizumab + Hydroxychloroquine|"bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one~Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days~hydroxychloroquine: hydroxychloroquine 200 mg po BID daily"
10990766|NCT01006369|FG001|Participant Flow|XELOX + Bevacizumab + Hydroxychloroquine|"bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one~Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days~XELOX regimen: Capecitabine will be started at a dose of 1,000 mg/m2/day bid po (total daily dose = 2,000 mg/m2) for 14 days (28 doses) of the 21 day cycle. This cycle will be repeated every 21 days. Oxaliplatin will be started at a dose of 130 mg/m2, in 250 ml of D5W over 2 hours given day 1 of each cycle. This cycle will be repeated every 21 days.~hydroxychloroquine: hydroxychloroquine 200 mg po BID daily"
10990767|NCT01006369|OG000|Outcome|FOLFOX6 + Bevacizumab + Hydroxychloroquine|"bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one~Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days~hydroxychloroquine: hydroxychloroquine 200 mg po BID daily"
10990768|NCT01006369|EG000|Reported Event|FOLFOX6 + Bevacizumab + Hydroxychloroquine|"bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one~Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days~hydroxychloroquine: hydroxychloroquine 200 mg po BID daily"
10990769|NCT01006369|EG001|Reported Event|XELOX + Bevacizumab + Hydroxychloroquine|"bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one~Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days~XELOX regimen: Capecitabine will be started at a dose of 1,000 mg/m2/day bid po (total daily dose = 2,000 mg/m2) for 14 days (28 doses) of the 21 day cycle. This cycle will be repeated every 21 days. Oxaliplatin will be started at a dose of 130 mg/m2, in 250 ml of D5W over 2 hours given day 1 of each cycle. This cycle will be repeated every 21 days.~hydroxychloroquine: hydroxychloroquine 200 mg po BID daily"
10990770|NCT01006538|BG000|Baseline|Arm A (Treatment)|"Arm A: A single surgical procedure with epimacular brachytherapy using the VIDION® System, with Lucentis® (0.5 mg) administered on a monthly basis as required.~Epimacular Brachytherapy: Strontium-90. The device delivers 24 Gray of beta radiation to the CNV lesion. Each device is calibrated for a set duration."
10990771|NCT01006538|BG001|Baseline|Arm B (Control):|"Arm B: Lucentis® (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria below.~Ranibizumab: intravitreal injection (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria"
10990772|NCT01006538|BG002|Baseline|Total|Total of all reporting groups
10990773|NCT01006538|FG000|Participant Flow|Arm A: Epimacular Bracytherapy + Lucentis®|"Arm A: A single surgical procedure with epimacular brachytherapy using the VIDION® System, with Lucentis® (0.5 mg) administered on a monthly basis as required.~Epimacular Brachytherapy: Strontium-90. The device delivers 24 Gray of beta radiation to the CNV lesion. Each device is calibrated for a set duration."
10990774|NCT01006538|FG001|Participant Flow|Arm B: Lucentis® Only|"Arm B: Lucentis® (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria below.~Ranibizumab: intravitreal injection (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria"
10990775|NCT01006538|OG000|Outcome|Arm A: Epimacular Bracytherapy + Lucentis®|"Arm A: A single surgical procedure with epimacular brachytherapy using the VIDION® System, with Lucentis® (0.5 mg) administered on a monthly basis as required.~Epimacular Brachytherapy: Strontium-90. The device delivers 24 Gray of beta radiation to the CNV lesion. Each device is calibrated for a set duration."
10990776|NCT01006538|OG001|Outcome|Arm B: Lucentis® Only|"Arm B: Lucentis® (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria below.~Ranibizumab: intravitreal injection (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria"
10990777|NCT01006538|EG000|Reported Event|Arm A: Epimacular Brachytherapy + Lucentis®|"Arm A: A single surgical procedure with epimacular brachytherapy using the VIDION® System, with Lucentis® (0.5 mg) administered on a monthly basis as required.~Epimacular Brachytherapy: Strontium-90. The device delivers 24 Gray of beta radiation to the CNV lesion. Each device is calibrated for a set duration.~Ranibizumab: intravitreal injection of Ranibizumab (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria"
10990778|NCT01006538|EG001|Reported Event|Arm B (Control): Lucentis ® Only|"Arm B: Lucentis® (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria below.~Ranibizumab: intravitreal injection of Ranibizumab (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria"
10990779|NCT01006590|BG000|Baseline|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
10990780|NCT01006590|BG001|Baseline|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
10990781|NCT01006590|BG002|Baseline|Total|Total of all reporting groups
10990782|NCT01006590|FG000|Participant Flow|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
10990783|NCT01006590|FG001|Participant Flow|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
10990784|NCT01006590|OG000|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
10990785|NCT01006590|OG001|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
10990786|NCT01006590|EG000|Reported Event|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
10990787|NCT01006590|EG001|Reported Event|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
10990788|NCT01006603|BG000|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
10990789|NCT01006603|BG001|Baseline|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
10990790|NCT01006603|BG002|Baseline|Total|Total of all reporting groups
10990791|NCT01006603|FG000|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
10990792|NCT01006603|FG001|Participant Flow|Glimepiride 1 - 6 mg|Glimepiride : 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
10990793|NCT01006603|OG000|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
10990794|NCT01006603|OG001|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
10990795|NCT01006603|EG000|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
10990796|NCT01006603|EG001|Reported Event|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
10990797|NCT01006616|BG000|Baseline|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
10990798|NCT01006616|BG001|Baseline|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
10990799|NCT01006616|BG002|Baseline|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
10990800|NCT01006616|BG003|Baseline|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
10990801|NCT01006616|BG004|Baseline|Total|Total of all reporting groups
10990802|NCT01006616|FG000|Participant Flow|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally once daily (QD) for up to 2 years
10990803|NCT01006616|FG001|Participant Flow|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
10990804|NCT01006616|FG002|Participant Flow|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
10990805|NCT01006616|FG003|Participant Flow|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
10990806|NCT01006616|OG000|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
10990807|NCT01006616|OG001|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
10990808|NCT01006616|OG002|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
10990809|NCT01006616|OG003|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
10990810|NCT01006616|EG000|Reported Event|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
10990811|NCT01006616|EG001|Reported Event|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
10990812|NCT01006616|EG002|Reported Event|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
10990813|NCT01006616|EG003|Reported Event|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
10990814|NCT01006629|BG000|Baseline|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
10990815|NCT01006629|FG000|Participant Flow|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
10990816|NCT01006629|OG000|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
10990817|NCT01006629|EG000|Reported Event|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
10990818|NCT01006655|BG000|Baseline|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
10990819|NCT01006655|BG001|Baseline|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
10990820|NCT01006655|BG002|Baseline|Total|Total of all reporting groups
10990821|NCT01006655|FG000|Participant Flow|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
11223229|NCT02352259|BG000|Baseline|Electrochemotherapy|All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
10990822|NCT01006655|FG001|Participant Flow|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
10990823|NCT01006655|OG000|Outcome|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
10990824|NCT01006655|OG001|Outcome|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
10990825|NCT01006655|EG000|Reported Event|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
10990826|NCT01006655|EG001|Reported Event|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
10990827|NCT01006707|BG000|Baseline|All Study Participants|All participants received placebo during Study Session 1 (placebo run-in), then were randomized to receive pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3, or pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
10990828|NCT01006707|FG000|Participant Flow|Placebo Run-in|Participants received pretreatment with placebo to match ondansetron in Study Session 1 prior to randomization to cross-over treatment arms in Study Sessions 2 and 3.
10990829|NCT01006707|FG001|Participant Flow|Ondansetron, Then Placebo|Participants received pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
10990830|NCT01006707|FG002|Participant Flow|Placebo, Then Ondansetron|Participants received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
10990831|NCT01006707|OG000|Outcome|All Ondansetron|All participants received pretreatment with ondansetron (8mg IV Bolus) and with placebo to match ondansetron. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
10990832|NCT01006707|OG000|Outcome|Ondansetron|Participants received pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
10990833|NCT01006707|OG001|Outcome|Placebo|Participants received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
10990834|NCT01006707|OG001|Outcome|Placebo|Participants received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded
10990835|NCT01006707|EG000|Reported Event|Ondansetron|Participants received placebo during Study Session 1 (placebo run-in), then received pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
10990836|NCT01006707|EG001|Reported Event|Placebo|Participants received placebo during Study Session 1 (placebo run-in), then received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
10990837|NCT01006889|BG000|Baseline|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
10990838|NCT01006889|FG000|Participant Flow|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
10990839|NCT01006889|OG000|Outcome|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
10990840|NCT01006889|OG000|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
10990841|NCT01006889|EG000|Reported Event|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
10990842|NCT01006967|BG000|Baseline|ActiveStep|"Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance~ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness."
10990843|NCT01006967|BG001|Baseline|Standard Physical Therapy|"Subjects will receive a standard physical therapy program for gait and balance.~Physical Therapy: Standard program of physical therapy for gait and balance"
10990844|NCT01006967|BG002|Baseline|Total|Total of all reporting groups
10990845|NCT01006967|FG000|Participant Flow|ActiveStep|"Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance~ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness."
10990846|NCT01006967|FG001|Participant Flow|Standard Physical Therapy|"Subjects will receive a standard physical therapy program for gait and balance.~Physical Therapy: Standard program of physical therapy for gait and balance"
10990847|NCT01006967|OG000|Outcome|ActiveStep|"Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance~ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness."
10990848|NCT01006967|OG001|Outcome|Standard Physical Therapy|"Subjects will receive a standard physical therapy program for gait and balance.~Physical Therapy: Standard program of physical therapy for gait and balance"
10990849|NCT01006967|OG000|Outcome|ActiveStep|
10990850|NCT01006967|OG001|Outcome|Standard Treatment|
10990851|NCT01006967|EG000|Reported Event|ActiveStep|Activestep Group
10990852|NCT01006967|EG001|Reported Event|Standard Treatment|Standard Treatment Group
10990853|NCT01006980|BG000|Baseline|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
10990854|NCT01006980|BG001|Baseline|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
10990855|NCT01006980|BG002|Baseline|Total|Total of all reporting groups
10990856|NCT01006980|FG000|Participant Flow|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
10990857|NCT01006980|FG001|Participant Flow|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
10990858|NCT01006980|OG000|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
10990859|NCT01006980|OG001|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
10990860|NCT01006980|EG000|Reported Event|Vemurafenib|"Adverse events reported for this group include those occurring in participants receiving vemurafenib starting at their baseline visit.~Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg)."
10990861|NCT01006980|EG001|Reported Event|Dacarbazine|"Adverse events reported for this group include those occurring in participants receiving dacarbazine starting at their baseline visit until study discontinuation or treatment switch.~Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length)."
10990862|NCT01006980|EG002|Reported Event|Vemurafenib After Crossover|Adverse events reported for this group include those occurring following switch to vemurafenib in those participants who switched from dacarbazine to vemurafenib during the study.
10990863|NCT01007032|BG000|Baseline|Cixutumumab Cohort 1|6 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
10990864|NCT01007032|BG001|Baseline|Cixutumumab Cohort 2|10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
10990865|NCT01007032|BG002|Baseline|Cixutumumab Cohort 3|15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990866|NCT01007032|BG003|Baseline|Cixutumumab Cohort 4|20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990867|NCT01007032|BG004|Baseline|Total|Total of all reporting groups
10990868|NCT01007032|FG000|Participant Flow|Cixutumumab Cohort 1|6 milligrams/kilograms (mg/kg) of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
10990869|NCT01007032|FG001|Participant Flow|Cixutumumab Cohort 2|10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
10990870|NCT01007032|FG002|Participant Flow|Cixutumumab Cohort 3|15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990871|NCT01007032|FG003|Participant Flow|Cixutumumab Cohort 4|20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990872|NCT01007032|OG000|Outcome|Cixutumumab Cohort 1|6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
10990873|NCT01007032|OG001|Outcome|Cixutumumab Cohort 2|10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
10990874|NCT01007032|OG002|Outcome|Cixutumumab Cohort 3|15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990875|NCT01007032|OG003|Outcome|Cixutumumab Cohort 4|20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990876|NCT01007032|OG000|Outcome|Cixutumumab 6 mg/kg|6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
10990877|NCT01007032|OG001|Outcome|Cixutumumab 10 mg/kg|10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
10990878|NCT01007032|OG002|Outcome|Cixutumumab 15 mg/kg|15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990879|NCT01007032|OG003|Outcome|Cixutumumab 20 mg/kg|20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990880|NCT01007032|OG000|Outcome|Cixutumumab Cohort 1|6 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
10990881|NCT01007032|EG000|Reported Event|Cixutumumab Cohort 1|6 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
10990882|NCT01007032|EG001|Reported Event|Cixutumumab Cohort 2|10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
10990883|NCT01007032|EG002|Reported Event|Cixutumumab Cohort 3|15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990884|NCT01007032|EG003|Reported Event|Cixutumumab Cohort 4|20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
10990885|NCT01007071|BG000|Baseline|Growth Hormone|"Subjects were randomized to receive growth Human Growth Hormone (1-134) (Nutropin) for 16 weeks~All subjects were diagnosed with growth hormone deficiency using standard testing."
10990886|NCT01007071|BG001|Baseline|Placebo|"Subjects were randomized to receive placebo for 16 weeks, and then were immediately crossed over to receive active study drug for 16 weeks~All subjects were diagnosed with growth hormone deficiency using standard testing."
10990887|NCT01007071|BG002|Baseline|Total|Total of all reporting groups
10990888|NCT01007071|FG000|Participant Flow|Growth Hormone|Subjects were randomized to receive growth Human Growth Hormone (1-134) (Nutropin) for 16 weeks
10990889|NCT01007071|FG001|Participant Flow|Placebo|Subjects were randomized to receive placebo for 16 weeks, and then were immediately crossed over to receive active study drug for 16 weeks
10990890|NCT01007071|OG000|Outcome|Growth Hormone|"Subjects randomized to growth hormone for 16 weeks~Human Growth Hormone (1-134): Subjects to receive growth hormone"
10990891|NCT01007071|OG001|Outcome|Placebo|Subjects randomized to placebo for 16 weeks Placebo: Subjects randomized to placebo
10990892|NCT01007071|OG001|Outcome|Placebo|"Subjects randomized to placebo for 16 weeks~Placebo: Subjects randomized to placebo"
10990893|NCT01007071|EG000|Reported Event|Human Growth Hormone (1-134)|This arm received study drug for 16 weeks. There were no serious adverse events.
10990894|NCT01007071|EG001|Reported Event|Placebo|This arm received placebo for 16 weeks. There were no serious adverse evens in this group.
10990895|NCT01007110|BG000|Baseline|Placebo|soy/corn oil placebo
10990896|NCT01007110|BG001|Baseline|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
10990897|NCT01007110|BG002|Baseline|Total|Total of all reporting groups
10990898|NCT01007110|FG000|Participant Flow|Placebo|soy/corn oil placebo
10990899|NCT01007110|FG001|Participant Flow|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
10990900|NCT01007110|OG000|Outcome|Placebo|soy/corn oil placebo
10990901|NCT01007110|OG001|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid (DHA)
10990902|NCT01007110|OG001|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
10990903|NCT01007110|EG000|Reported Event|Placebo|soy/corn oil placebo
10990904|NCT01007110|EG001|Reported Event|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
10990905|NCT01007123|BG000|Baseline|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
10990906|NCT01007123|BG001|Baseline|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
10990907|NCT01007123|BG002|Baseline|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
10990908|NCT01007123|BG003|Baseline|Placebo|Administered once daily for the duration of the study
10990909|NCT01007123|BG004|Baseline|Total|Total of all reporting groups
10990910|NCT01007123|FG000|Participant Flow|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
10990911|NCT01007123|FG001|Participant Flow|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
10990912|NCT01007123|FG002|Participant Flow|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
10990913|NCT01007123|FG003|Participant Flow|Placebo|Administered once daily for the duration of the study
10990914|NCT01007123|OG000|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
10990915|NCT01007123|OG001|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
10990916|NCT01007123|OG002|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
10990917|NCT01007123|OG003|Outcome|Placebo|Administered once daily for the duration of the study
10990918|NCT01007123|OG001|Outcome|Eobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
10990919|NCT01007123|EG000|Reported Event|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
10990920|NCT01007123|EG001|Reported Event|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
10990921|NCT01007123|EG002|Reported Event|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
10990922|NCT01007123|EG003|Reported Event|Placebo|Administered once daily for the duration of the study
10990923|NCT01007136|BG000|Baseline|tDCS and Occupational Therapy|"1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.~tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy."
10990924|NCT01007136|BG001|Baseline|Sham and Occupational Therapy|"Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.~Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy."
10990925|NCT01007136|BG002|Baseline|fMRI Control Group no Intervention|Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed.
10990926|NCT01007136|BG003|Baseline|tDCS and no Arm Movement|"1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment.~tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy."
10990927|NCT01007136|BG004|Baseline|Sham and no Arm Movement|"Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.~Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy."
10990928|NCT01007136|BG005|Baseline|Total|Total of all reporting groups
10990929|NCT01007136|FG000|Participant Flow|tDCS and Occupational Therapy|"1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.~tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy."
10990930|NCT01007136|FG001|Participant Flow|Sham and Occupational Therapy|"Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.~Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy."
10990931|NCT01007136|FG002|Participant Flow|fMRI Control Group no Intervention|Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed.The purpose of this study subgroup was to set up and test the complex MRI and TMS protocol developed for this project.
10990932|NCT01007136|FG003|Participant Flow|tDCS and no Arm Movement|"1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment.~tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy."
10990933|NCT01007136|FG004|Participant Flow|Sham and no Arm Movement|Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
10990934|NCT01007136|OG000|Outcome|tDCS and Occupational Therapy|"1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.~tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy."
10990935|NCT01007136|OG001|Outcome|Sham and Occupational Therapy|"Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.~Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy."
11348211|NCT04204200|EG002|Reported Event|Allocated to Placebo (n= 22)|Participant intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure).
10990936|NCT01007136|OG002|Outcome|tDCS and no Arm Movement|"1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment.~tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy."
10990937|NCT01007136|OG003|Outcome|Sham and no Arm Movement|"Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.~Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy."
10990938|NCT01007136|EG000|Reported Event|tDCS and Occupational Therapy|"1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.~tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy."
10990939|NCT01007136|EG001|Reported Event|Sham and Occupational Therapy|"Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.~Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy."
10990940|NCT01007136|EG002|Reported Event|fMRI Control Group no Intervention|Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed.
10990941|NCT01007136|EG003|Reported Event|tDCS and no Arm Movement|"1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment.~tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy."
10990942|NCT01007136|EG004|Reported Event|Sham and no Arm Movement|"Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.~Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy."
10990943|NCT01007149|BG000|Baseline|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
10990944|NCT01007149|BG001|Baseline|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
10990945|NCT01007149|BG002|Baseline|Total|Total of all reporting groups
10990946|NCT01007149|FG000|Participant Flow|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
10990947|NCT01007149|FG001|Participant Flow|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
10990948|NCT01007149|OG000|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
10990949|NCT01007149|OG001|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
10990950|NCT01007149|EG000|Reported Event|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
10990951|NCT01007149|EG001|Reported Event|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
11223230|NCT02352259|FG000|Participant Flow|Electrochemotherapy|All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
10990952|NCT01007253|BG000|Baseline|Entire Study Population|Includes groups randomized to receive PL/PL first, FF/PL first, PL/OLO first, and FF/OLO first.
10990953|NCT01007253|FG000|Participant Flow|FF/PL, PL/OLO, FF/OLO, PL/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and~placebo (PL) nasal spray and PL eye drops (PL/PL)."
10990954|NCT01007253|FG001|Participant Flow|PL/OLO, FF/OLO, PL/PL, FF/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),~placebo (PL) nasal spray and PL eye drops (PL/PL), and~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)."
10990955|NCT01007253|FG002|Participant Flow|FF/OLO, PL/PL, FF/PL, PL/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),~placebo (PL) nasal spray and PL eye drops (PL/PL),~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO)."
10990956|NCT01007253|FG003|Participant Flow|PL/PL, FF/PL, PL/OLO, FF/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~placebo (PL) nasal spray and PL eye drops (PL/PL),~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL),~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO)."
10990957|NCT01007253|OG000|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
10990958|NCT01007253|OG001|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
10990959|NCT01007253|OG002|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
10990960|NCT01007253|OG003|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
10990961|NCT01007253|EG000|Reported Event|PL/PL|placebo (PL) nasal spray and PL eye drops
10990962|NCT01007253|EG001|Reported Event|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
10990963|NCT01007253|EG002|Reported Event|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
10990964|NCT01007253|EG003|Reported Event|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
10990965|NCT01007396|BG000|Baseline|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
10990966|NCT01007396|FG000|Participant Flow|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
10990967|NCT01007396|OG000|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
10990968|NCT01007396|EG000|Reported Event|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
10990969|NCT01007435|BG000|Baseline|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
10990970|NCT01007435|BG001|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
10990971|NCT01007435|BG002|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
10990972|NCT01007435|BG003|Baseline|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
10990973|NCT01007435|BG004|Baseline|Total|Total of all reporting groups
10990974|NCT01007435|FG000|Participant Flow|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
10990975|NCT01007435|FG001|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
10990976|NCT01007435|FG002|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
10990977|NCT01007435|FG003|Participant Flow|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
10990978|NCT01007435|OG000|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
10990979|NCT01007435|OG001|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
10990980|NCT01007435|OG002|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
10990981|NCT01007435|OG003|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
10990982|NCT01007435|EG000|Reported Event|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
10990983|NCT01007435|EG001|Reported Event|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
10990984|NCT01007435|EG002|Reported Event|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
10990985|NCT01007435|EG003|Reported Event|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
10990986|NCT01007448|BG000|Baseline|Bexarotene 150 mg/m^2/Day|Participants received bexarotene 150 mg/m^2/day once daily for 24 weeks.
10990987|NCT01007448|BG001|Baseline|Bexarotene 300 mg/m^2/Day|Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks.
10990988|NCT01007448|BG002|Baseline|Total|Total of all reporting groups
10990989|NCT01007448|FG000|Participant Flow|Bexarotene 150 mg/m^2/Day|Participants received bexarotene 150 mg/m^2/day once daily for 24 weeks.
10990990|NCT01007448|FG001|Participant Flow|Bexarotene 300 mg/m^2/Day|Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks.
10990991|NCT01007448|OG000|Outcome|Bexarotene 150 mg/m^2/Day|Participants received bexarotene 150 mg/m^2/day once daily for 24 weeks.
10990992|NCT01007448|OG001|Outcome|Bexarotene 300 mg/m^2/Day|Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks.
10990993|NCT01007448|EG000|Reported Event|Bexarotene 150 mg/m^2/Day|Participants received bexarotene 150 mg/m^2/day once daily for 24 weeks.
10990994|NCT01007448|EG001|Reported Event|Bexarotene 300 mg/m^2/Day|Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks.
10990995|NCT01007526|BG000|Baseline|CCRT Plus VIDL|CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
10990996|NCT01007526|FG000|Participant Flow|CCRT Plus VIDL|CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
10990997|NCT01007526|OG000|Outcome|CCRT Plus VIDL|CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
10990998|NCT01007526|EG000|Reported Event|CCRT Plus VIDL|CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
10990999|NCT01007552|BG000|Baseline|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
10991000|NCT01007552|FG000|Participant Flow|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
10991001|NCT01007552|OG000|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
10991002|NCT01007552|EG000|Reported Event|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
10991003|NCT01007591|BG000|Baseline|LEO 80190 Ointment|LEO 80190: Applied once daily
10991004|NCT01007591|BG001|Baseline|Hydrocortisone 10 mg/g Ointment|Hydrocortisone: Applied once daily
10991005|NCT01007591|BG002|Baseline|Total|Total of all reporting groups
10991006|NCT01007591|FG000|Participant Flow|LEO 80190 Ointment|LEO 80190: Applied once daily
10991007|NCT01007591|FG001|Participant Flow|Hydrocortisone 10 mg/g Ointment|Hydrocortisone: Applied once daily
10991008|NCT01007591|OG000|Outcome|LEO 80190 Ointment|LEO 80190: Applied once daily
10991009|NCT01007591|OG001|Outcome|Hydrocortisone 10 mg/g Ointment|Hydrocortisone: Applied once daily
10991010|NCT01007591|EG000|Reported Event|LEO 80190 Ointment|LEO 80190: Applied once daily
10991011|NCT01007591|EG001|Reported Event|Hydrocortisone 10 mg/g Ointment|Hydrocortisone: Applied once daily
10991012|NCT01007643|BG000|Baseline|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
10991013|NCT01007643|BG001|Baseline|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
10991014|NCT01007643|BG002|Baseline|Total|Total of all reporting groups
10991015|NCT01007643|FG000|Participant Flow|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
10991016|NCT01007643|FG001|Participant Flow|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
10991017|NCT01007643|OG000|Outcome|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
10991018|NCT01007643|OG001|Outcome|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
10991019|NCT01007643|EG000|Reported Event|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
10991020|NCT01007643|EG001|Reported Event|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
10991021|NCT01007656|BG000|Baseline|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
10991022|NCT01007656|FG000|Participant Flow|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
10991023|NCT01007656|OG000|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
10991024|NCT01007656|EG000|Reported Event|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
10991025|NCT01007812|BG000|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
10991026|NCT01007812|FG000|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
10991027|NCT01007812|FG001|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
10991028|NCT01007812|OG000|Outcome|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
10991029|NCT01007812|OG001|Outcome|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
10991030|NCT01007812|EG000|Reported Event|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
10991031|NCT01007812|EG001|Reported Event|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
10991032|NCT01007838|BG000|Baseline|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
10991033|NCT01007838|BG001|Baseline|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
10991034|NCT01007838|BG002|Baseline|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
10991035|NCT01007838|BG003|Baseline|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
10991036|NCT01007838|BG004|Baseline|Total|Total of all reporting groups
10991037|NCT01007838|FG000|Participant Flow|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
10991038|NCT01007838|FG001|Participant Flow|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
10991039|NCT01007838|FG002|Participant Flow|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
10991040|NCT01007838|FG003|Participant Flow|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
10991041|NCT01007838|OG000|Outcome|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
10846474|NCT00276380|EG000|Reported Event|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch"
10991042|NCT01007838|OG001|Outcome|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
10991043|NCT01007838|OG002|Outcome|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
10991044|NCT01007838|OG003|Outcome|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
10991045|NCT01007838|EG000|Reported Event|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
10991046|NCT01007838|EG001|Reported Event|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
10991047|NCT01007838|EG002|Reported Event|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
10991048|NCT01007838|EG003|Reported Event|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
10991049|NCT01007916|BG000|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
10991050|NCT01007916|FG000|Participant Flow|Lotrafilcon B / Habitual|Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
10991051|NCT01007916|FG001|Participant Flow|Habitual / Lotrafilcon B|Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
10991052|NCT01007916|OG000|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
10991053|NCT01007916|OG001|Outcome|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
10991054|NCT01007916|EG000|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
10991055|NCT01007916|EG001|Reported Event|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
10991056|NCT01007942|BG000|Baseline|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
10991057|NCT01007942|BG001|Baseline|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
10991058|NCT01007942|BG002|Baseline|Total|Total of all reporting groups
10991059|NCT01007942|FG000|Participant Flow|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
10991060|NCT01007942|FG001|Participant Flow|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
10991061|NCT01007942|OG000|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
10991062|NCT01007942|OG001|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
10991063|NCT01007942|OG000|Outcome|Everolimus 2.5 mg|Oral everolimus of 2.5 mg/day
10991064|NCT01007942|OG001|Outcome|Everolimus|Oral everolimus of 5 mg/day
10991065|NCT01007942|OG000|Outcome|Everolimus|Oral everolimus of 5 mg/day
10991066|NCT01007942|OG001|Outcome|Everolimus Placebo|Oral placebo everolimus of 5 mg/day
10991067|NCT01007942|EG000|Reported Event|Everolimus + Trastuzumab + Vinorelbine|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
10991068|NCT01007942|EG001|Reported Event|Placebo + Trastuzumab + Vinorelbine|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
10991069|NCT01007994|BG000|Baseline|New Medication|"A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm.~New Medication: Enalapril, Isradipine, Propranolol: Enalapril will be added in the evening at 8 pm. If the subject is already on an ACEI or there is a contraindication to starting an ACEI the subject will be started on isradipine instead. If the subject is already on an ACEI and calcium channel blocker at baseline, propranolol will then be the new medication added.~Dosing will be as follows:~ACEI: Enalapril < 40 kg starting dose 2.5 mg titrate to 5 mg > 40 kg starting dose 5 mg titrate to 10mg Calcium Channel Blocker: Isradipine < 40 kg 2.5 mg > 40 kg starting dose 2.5 mg titrate to 5 mg Beta Blocker: Propranolol <40 kg starting dose 10 mg titrate to 20 mg >40 kg starting dose 20 mg titrate to 40 mg"
10991070|NCT01007994|BG001|Baseline|Control|Subjects in the control group will continue to take their medications as usual.
10991071|NCT01007994|BG002|Baseline|Total|Total of all reporting groups
10991072|NCT01007994|FG000|Participant Flow|New Medication|"A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm.~New Medication: Enalapril, Isradipine, Propranolol: Enalapril will be added in the evening at 8 pm. If the subject is already on an ACEI or there is a contraindication to starting an ACEI the subject will be started on isradipine instead. If the subject is already on an ACEI and calcium channel blocker at baseline, propranolol will then be the new medication added.~Dosing will be as follows:~ACEI: Enalapril < 40 kg starting dose 2.5 mg titrate to 5 mg > 40 kg starting dose 5 mg titrate to 10mg Calcium Channel Blocker: Isradipine < 40 kg 2.5 mg > 40 kg starting dose 2.5 mg titrate to 5 mg Beta Blocker: Propranolol <40 kg starting dose 10 mg titrate to 20 mg >40 kg starting dose 20 mg titrate to 40 mg"
10991073|NCT01007994|FG001|Participant Flow|Control|Subjects in the control group will continue to take their medications as usual.
10991074|NCT01007994|OG000|Outcome|New Medication|"A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm.~New Medication: Enalapril, Isradipine, Propranolol: Enalapril will be added in the evening at 8 pm. If the subject is already on an ACEI or there is a contraindication to starting an ACEI the subject will be started on isradipine instead. If the subject is already on an ACEI and calcium channel blocker at baseline, propranolol will then be the new medication added.~Dosing will be as follows:~ACEI: Enalapril < 40 kg starting dose 2.5 mg titrate to 5 mg > 40 kg starting dose 5 mg titrate to 10mg Calcium Channel Blocker: Isradipine < 40 kg 2.5 mg > 40 kg starting dose 2.5 mg titrate to 5 mg Beta Blocker: Propranolol <40 kg starting dose 10 mg titrate to 20 mg >40 kg starting dose 20 mg titrate to 40 mg"
10991075|NCT01007994|OG001|Outcome|Control|Subjects in the control group will continue to take their medications as usual.
10991076|NCT01007994|EG000|Reported Event|New Medication|"A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm.~New Medication: Enalapril, Isradipine, Propranolol: Enalapril will be added in the evening at 8 pm. If the subject is already on an ACEI or there is a contraindication to starting an ACEI the subject will be started on isradipine instead. If the subject is already on an ACEI and calcium channel blocker at baseline, propranolol will then be the new medication added.~Dosing will be as follows:~ACEI: Enalapril < 40 kg starting dose 2.5 mg titrate to 5 mg > 40 kg starting dose 5 mg titrate to 10mg Calcium Channel Blocker: Isradipine < 40 kg 2.5 mg > 40 kg starting dose 2.5 mg titrate to 5 mg Beta Blocker: Propranolol <40 kg starting dose 10 mg titrate to 20 mg >40 kg starting dose 20 mg titrate to 40 mg"
10991077|NCT01007994|EG001|Reported Event|Control|Subjects in the control group will continue to take their medications as usual.
10991078|NCT01008059|BG000|Baseline|Alfentanil|
10991079|NCT01008059|FG000|Participant Flow|Control Sequential Alfentanil|Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil. Control.
10991080|NCT01008059|FG001|Participant Flow|Rifampin Sequential Alfentanil|Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment
10991081|NCT01008059|FG002|Participant Flow|Grapefruit Juice Sequential Alfentanil|Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice
10991082|NCT01008059|FG003|Participant Flow|Ketoconazole Sequential Alfentanil|Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3d ketoconazole
10991083|NCT01008059|FG004|Participant Flow|Control Simultaneous Alfentanil|Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil.Control.
10991084|NCT01008059|FG005|Participant Flow|Rifampin Simultaneous Alfentanil|Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment
10991085|NCT01008059|FG006|Participant Flow|Grapefruit Juice Simultaneous Alfentanil|Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice
10991086|NCT01008059|FG007|Participant Flow|Ketoconazole Simultaneous Alfentanil|Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3d ketoconazole
10991087|NCT01008059|OG000|Outcome|Alfentanil|
10991088|NCT01008059|EG000|Reported Event|Control Sequential Alfentanil|Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil. Control.
10991089|NCT01008059|EG001|Reported Event|Refampin Sequential Alfentanil|Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment
10991090|NCT01008059|EG002|Reported Event|Grapefruit Juice Sequential Alfentanil|Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice
10991091|NCT01008059|EG003|Reported Event|Ketoconazole Sequential Alfentanil|Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3d ketoconazole
10991092|NCT01008059|EG004|Reported Event|Control Simultaneous Alfentanil|Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil.Control
10991093|NCT01008059|EG005|Reported Event|Rifampin Simultaneous Alfentanil|Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment
10991094|NCT01008059|EG006|Reported Event|Grapefruit Juice Simultaneous Alfentanil|Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice
10991095|NCT01008059|EG007|Reported Event|Ketoconazole Simultaneous Alfentanil|Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3d ketoconazole
10991096|NCT01008150|BG000|Baseline|Arm 1: Paclitaxel + Trastuzumab Then A C|"4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Doxorubicin~Cyclophosphamide"
10991097|NCT01008150|BG001|Baseline|Arm 2: Paclitaxel + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Neratinib~Doxorubicin~Cyclophosphamide"
10991098|NCT01008150|BG002|Baseline|Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
10991099|NCT01008150|BG003|Baseline|Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
10991100|NCT01008150|BG004|Baseline|Total|Total of all reporting groups
10991101|NCT01008150|FG000|Participant Flow|Arm 1: Paclitaxel + Trastuzumab Then A C|"4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Doxorubicin~Cyclophosphamide"
10991102|NCT01008150|FG001|Participant Flow|Arm 2: Paclitaxel + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Neratinib~Doxorubicin~Cyclophosphamide"
10991103|NCT01008150|FG002|Participant Flow|Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
11007383|NCT01090453|OG001|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
10991104|NCT01008150|FG003|Participant Flow|Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
10991105|NCT01008150|OG000|Outcome|Arm 1: Paclitaxel + Trastuzumab Then A C|"4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Doxorubicin~Cyclophosphamide"
10991106|NCT01008150|OG001|Outcome|Arm 2: Paclitaxel + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Neratinib~Doxorubicin~Cyclophosphamide"
10991107|NCT01008150|OG002|Outcome|Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
10991108|NCT01008150|OG003|Outcome|Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
10991109|NCT01008150|OG003|Outcome|Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
10991110|NCT01008150|EG000|Reported Event|Arm 1: Paclitaxel + Trastuzumab Then A C|"4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Doxorubicin~Cyclophosphamide"
10991111|NCT01008150|EG001|Reported Event|Arm 2: Paclitaxel + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Neratinib~Doxorubicin~Cyclophosphamide"
10991112|NCT01008150|EG002|Reported Event|Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
10991113|NCT01008150|EG003|Reported Event|Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC|"4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)~Paclitaxel~Trastuzumab~Neratinib~Doxorubicin~Cyclophosphamide"
10991114|NCT01008280|BG000|Baseline|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
10991115|NCT01008280|BG001|Baseline|Placebo|"placebo given tid~placebo: placebo pill tid"
10991116|NCT01008280|BG002|Baseline|Total|Total of all reporting groups
10991117|NCT01008280|FG000|Participant Flow|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
10991118|NCT01008280|FG001|Participant Flow|Placebo|"placebo given tid~placebo: placebo pill tid"
10991119|NCT01008280|OG000|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
10991120|NCT01008280|OG001|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
10991121|NCT01008280|EG000|Reported Event|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
10991122|NCT01008280|EG001|Reported Event|Placebo|"placebo given tid~placebo: placebo pill tid"
10991123|NCT01008319|BG000|Baseline|Traditional Administration|
10991124|NCT01008319|BG001|Baseline|Stair-Step Administration|
10991125|NCT01008319|BG002|Baseline|Total|Total of all reporting groups
10991126|NCT01008319|FG000|Participant Flow|Traditional Administration|"The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 5). If ovulation does not occur by day 21 then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.~This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg)."
10991127|NCT01008319|FG001|Participant Flow|Stair-Step Administration|The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
10991128|NCT01008319|OG000|Outcome|Traditional Administration|"The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.~clomiphene citrate: Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present."
10991129|NCT01008319|OG001|Outcome|Stair-Step Administration|The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
10991130|NCT01008319|OG000|Outcome|Traditional Protocol|The proportion that ovulated at the dose of Clomid of 60 patients in the traditional protocol.
10991131|NCT01008319|OG001|Outcome|Stair-Step Protocol|The proportion that ovulated at the dose of Clomid of 60 patients in the stair-step protocol.
10991132|NCT01008319|OG000|Outcome|Traditional Protocol|Proportion of subjects that delivered in the traditional protocol.
10991133|NCT01008319|OG001|Outcome|Stair-Step Protocol|Proportion of subjects that delivered in the stair-step protocol.
10991134|NCT01008319|EG000|Reported Event|Traditional Administration|"The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.~clomiphene citrate: Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present."
10991135|NCT01008319|EG001|Reported Event|Stair-Step Administration|The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
10991136|NCT01008410|BG000|Baseline|Budesonide|Participants who were diagnosed with active mild to moderate (UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
10991137|NCT01008410|BG001|Baseline|Placebo|Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
10991138|NCT01008410|BG002|Baseline|Total|Total of all reporting groups
10991139|NCT01008410|FG000|Participant Flow|Budesonide|Participants who were diagnosed with active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS), received 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
10991140|NCT01008410|FG001|Participant Flow|Placebo|Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
10991141|NCT01008410|OG000|Outcome|Budesonide|Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
10991142|NCT01008410|OG001|Outcome|Placebo|Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
10991143|NCT01008410|EG000|Reported Event|Budesonide|Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
10991144|NCT01008410|EG001|Reported Event|Placebo|Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
10991145|NCT01008423|BG000|Baseline|Budesonide|Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
10991146|NCT01008423|BG001|Baseline|Placebo|Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
10991147|NCT01008423|BG002|Baseline|Total|Total of all reporting groups
10991148|NCT01008423|FG000|Participant Flow|Budesonide|Participants who were diagnosed with active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS), received 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
10991149|NCT01008423|FG001|Participant Flow|Placebo|Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
10991150|NCT01008423|OG000|Outcome|Budesonide|Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
10991151|NCT01008423|OG001|Outcome|Placebo|Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
10991152|NCT01008423|EG000|Reported Event|Budesonide|Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
10991153|NCT01008423|EG001|Reported Event|Placebo|Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
10991154|NCT01008449|BG000|Baseline|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
10991155|NCT01008449|BG001|Baseline|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
10991156|NCT01008449|BG002|Baseline|Total|Total of all reporting groups
10991157|NCT01008449|FG000|Participant Flow|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
10991158|NCT01008449|FG001|Participant Flow|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
10991159|NCT01008449|OG000|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
10991160|NCT01008449|OG001|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
10991161|NCT01008449|EG000|Reported Event|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
10991162|NCT01008449|EG001|Reported Event|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
10991163|NCT01008462|BG000|Baseline|Treatment (Autologous HCT, Donor HCT)|"Allogeneic Bone Marrow Transplantation: Undergo donor HCT~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT~Carmustine: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative study~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo donor HCT~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo TBI"
10991164|NCT01008462|FG000|Participant Flow|Treatment (Autologous HCT, Donor HCT)|"Allogeneic Bone Marrow Transplantation: Undergo donor HCT~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT~Carmustine: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative study~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo donor HCT~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo TBI"
11007384|NCT01090453|EG000|Reported Event|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
10991165|NCT01008462|OG000|Outcome|Treatment (Autologous HCT, Donor HCT)|"Allogeneic Bone Marrow Transplantation: Undergo donor HCT~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT~Carmustine: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative study~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo donor HCT~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo TBI"
10991166|NCT01008462|EG000|Reported Event|Treatment (Autologous HCT, Donor HCT)|"Allogeneic Bone Marrow Transplantation: Undergo donor HCT~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT~Carmustine: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative study~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo donor HCT~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo TBI"
10991167|NCT01008475|BG000|Baseline|Safety Part: EMD 525797 250 mg + Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991168|NCT01008475|BG001|Baseline|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991169|NCT01008475|BG002|Baseline|Safety Part: EMD 525797 750 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991170|NCT01008475|BG003|Baseline|Safety Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991171|NCT01008475|BG004|Baseline|Randomized Part: SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991172|NCT01008475|BG005|Baseline|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991173|NCT01008475|BG006|Baseline|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991174|NCT01008475|BG007|Baseline|Total|Total of all reporting groups
10991175|NCT01008475|FG000|Participant Flow|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991176|NCT01008475|FG001|Participant Flow|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991177|NCT01008475|FG002|Participant Flow|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991178|NCT01008475|FG003|Participant Flow|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991179|NCT01008475|FG004|Participant Flow|Randomized Part: Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991180|NCT01008475|FG005|Participant Flow|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991181|NCT01008475|FG006|Participant Flow|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991182|NCT01008475|OG000|Outcome|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991183|NCT01008475|OG001|Outcome|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991184|NCT01008475|OG002|Outcome|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991185|NCT01008475|OG003|Outcome|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991186|NCT01008475|OG000|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991187|NCT01008475|OG001|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991188|NCT01008475|OG002|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991189|NCT01008475|EG000|Reported Event|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991190|NCT01008475|EG001|Reported Event|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991191|NCT01008475|EG002|Reported Event|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991192|NCT01008475|EG003|Reported Event|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991193|NCT01008475|EG004|Reported Event|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991194|NCT01008475|EG005|Reported Event|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991195|NCT01008475|EG006|Reported Event|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
10991196|NCT01008553|BG000|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
11223231|NCT02352259|OG000|Outcome|Electrochemotherapy|All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
10991197|NCT01008553|FG000|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
10991198|NCT01008553|FG001|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991199|NCT01008553|FG002|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991200|NCT01008553|OG000|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991201|NCT01008553|OG001|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991202|NCT01008553|OG000|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
10991203|NCT01008553|OG000|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
10991204|NCT01008553|EG000|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
10991205|NCT01008553|EG001|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991206|NCT01008553|EG002|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991207|NCT01008605|BG000|Baseline|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
10991208|NCT01008605|FG000|Participant Flow|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
10991209|NCT01008605|OG000|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
10991210|NCT01008605|OG000|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
10991211|NCT01008605|OG001|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
10991212|NCT01008605|OG002|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
10991213|NCT01008605|OG003|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
10991214|NCT01008605|OG004|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
10991215|NCT01008605|OG005|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
10991216|NCT01008605|OG006|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
10991217|NCT01008605|OG007|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
10991218|NCT01008605|EG000|Reported Event|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
10991219|NCT01008618|BG000|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
10991220|NCT01008618|FG000|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
10991221|NCT01008618|FG001|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991222|NCT01008618|FG002|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991223|NCT01008618|OG000|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991224|NCT01008618|OG001|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991225|NCT01008618|OG000|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
10991226|NCT01008618|OG000|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
10991227|NCT01008618|EG000|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
11348212|NCT04196907|BG000|Baseline|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin."
10991228|NCT01008618|EG001|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991229|NCT01008618|EG002|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
10991230|NCT01008696|BG000|Baseline|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
10991231|NCT01008696|BG001|Baseline|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
10991232|NCT01008696|BG002|Baseline|Total|Total of all reporting groups
10991233|NCT01008696|FG000|Participant Flow|Rabeprazole|Rabeprazole 20 milligram (mg) tablet orally once daily before breakfast for 28 to 56 days
10991234|NCT01008696|FG001|Participant Flow|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
10991235|NCT01008696|OG000|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
10991236|NCT01008696|OG001|Outcome|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
10991237|NCT01008696|OG001|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
10991238|NCT01008696|EG000|Reported Event|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
10991239|NCT01008696|EG001|Reported Event|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
10991240|NCT01008722|BG000|Baseline|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
11348213|NCT04196907|FG000|Participant Flow|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin."
10991241|NCT01008722|BG001|Baseline|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
10991242|NCT01008722|BG002|Baseline|Total|Total of all reporting groups
10991243|NCT01008722|FG000|Participant Flow|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
10991244|NCT01008722|FG001|Participant Flow|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
10991245|NCT01008722|OG000|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
10991246|NCT01008722|OG001|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
10991247|NCT01008722|EG000|Reported Event|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
10991248|NCT01008722|EG001|Reported Event|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
10991249|NCT01008748|BG000|Baseline|Smoking Cessation Treatment|NRT, self-help materials + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits.
10991250|NCT01008748|FG000|Participant Flow|Smoking Cessation Treatment|6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions in 26 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
10991251|NCT01008748|OG000|Outcome|Smoking Cessation Treatment|6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
10991252|NCT01008748|EG000|Reported Event|Smoking Cessation Treatment|6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
10991253|NCT01008904|BG000|Baseline|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
10991254|NCT01008904|FG000|Participant Flow|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
10991255|NCT01008904|OG000|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
10991256|NCT01008904|EG000|Reported Event|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
10991257|NCT01008943|BG000|Baseline|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
10991258|NCT01008943|FG000|Participant Flow|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
10991259|NCT01008943|OG000|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
10991260|NCT01008943|EG000|Reported Event|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
10991261|NCT01008969|BG000|Baseline|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
10991262|NCT01008969|FG000|Participant Flow|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
10991263|NCT01008969|OG000|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
10991264|NCT01008969|EG000|Reported Event|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
10991265|NCT01008995|BG000|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10991266|NCT01008995|BG001|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
10991267|NCT01008995|BG002|Baseline|Total|Total of all reporting groups
10991268|NCT01008995|FG000|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10991269|NCT01008995|FG001|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
10991270|NCT01008995|FG002|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
10991271|NCT01008995|FG003|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
10991272|NCT01008995|OG000|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10991273|NCT01008995|OG001|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
10991274|NCT01008995|EG000|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10991275|NCT01008995|EG001|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
10991276|NCT01008995|EG002|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
10991277|NCT01008995|EG003|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
10991278|NCT01009034|BG000|Baseline|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
10991279|NCT01009034|FG000|Participant Flow|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
10991280|NCT01009034|OG000|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
10991281|NCT01009034|EG000|Reported Event|12 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
10991282|NCT01009047|BG000|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
10991283|NCT01009047|BG001|Baseline|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
10991284|NCT01009047|BG002|Baseline|Total|Total of all reporting groups
10991285|NCT01009047|FG000|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
10991286|NCT01009047|FG001|Participant Flow|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
10991287|NCT01009047|OG000|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
10991288|NCT01009047|OG001|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
10991289|NCT01009047|EG000|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
10991290|NCT01009047|EG001|Reported Event|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
10991291|NCT01009060|BG000|Baseline|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
10991292|NCT01009060|BG001|Baseline|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
10991293|NCT01009060|BG002|Baseline|Total|Total of all reporting groups
10991294|NCT01009060|FG000|Participant Flow|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
10991295|NCT01009060|FG001|Participant Flow|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
10991296|NCT01009060|OG000|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
10991297|NCT01009060|OG001|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
10991298|NCT01009060|OG000|Outcome|GSK239512 10 mcg|Par. received GSK239512 10 mcg daily as dose level 1 in the first week of study.
10991299|NCT01009060|OG001|Outcome|GSK239512 20 mcg|Par. received GSK239512 20 mcg daily as dose level 2 in the second week of study.
10991300|NCT01009060|OG002|Outcome|GSK239512 40 mcg|Par. received GSK239512 40 mcg daily as dose level 3 in the third week of study.
10991301|NCT01009060|OG003|Outcome|GSK239512 80 mcg|Par. received GSK239512 80 mcg daily as dose level 4 in the fourth week of study and continued to receive from fifth to seventh week as maintenance phase.
10991302|NCT01009060|EG000|Reported Event|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
10991303|NCT01009060|EG001|Reported Event|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 μg GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
10991304|NCT01009086|BG000|Baseline|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
10991305|NCT01009086|BG001|Baseline|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
10991306|NCT01009086|BG002|Baseline|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
10991307|NCT01009086|BG003|Baseline|Total|Total of all reporting groups
10991308|NCT01009086|FG000|Participant Flow|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
10991309|NCT01009086|FG001|Participant Flow|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
10991310|NCT01009086|FG002|Participant Flow|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
10991311|NCT01009086|OG000|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
10991312|NCT01009086|OG001|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
10991313|NCT01009086|OG002|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
10991314|NCT01009086|OG003|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
10991315|NCT01009086|EG000|Reported Event|Placebo (CP)|Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
10991316|NCT01009086|EG001|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
10991317|NCT01009086|EG002|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
10991318|NCT01009086|EG003|Reported Event|Placebo (After CP)|After Controlled period (Week 16-24) - participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
10991319|NCT01009086|EG004|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) - participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
10991320|NCT01009086|EG005|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) - participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
10991321|NCT01009086|EG006|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 16-108) - participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
10991322|NCT01009099|BG000|Baseline|Arm 1|"exercise training with breathing retraining~breathing retraining: breathing retraining using a metronome~exercise training: treadmill exercise training"
10991323|NCT01009099|BG001|Baseline|Arm 2|"exercise training~exercise training: treadmill exercise training"
10991324|NCT01009099|BG002|Baseline|Total|Total of all reporting groups
10991325|NCT01009099|FG000|Participant Flow|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
10991326|NCT01009099|FG001|Participant Flow|Exercise Training|treadmill exercise training
10991327|NCT01009099|OG000|Outcome|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
10991328|NCT01009099|OG001|Outcome|Exercise Training|treadmill exercise training
10991329|NCT01009099|EG000|Reported Event|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
10991330|NCT01009099|EG001|Reported Event|Exercise Training|treadmill exercise training
10991331|NCT01009138|BG000|Baseline|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
10991332|NCT01009138|BG001|Baseline|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
10991333|NCT01009138|BG002|Baseline|Total|Total of all reporting groups
10991334|NCT01009138|FG000|Participant Flow|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
10991335|NCT01009138|FG001|Participant Flow|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
10991336|NCT01009138|OG000|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
10991337|NCT01009138|OG001|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
10991338|NCT01009138|EG000|Reported Event|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
10991339|NCT01009138|EG001|Reported Event|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
10991340|NCT01009203|BG000|Baseline|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
10991341|NCT01009203|FG000|Participant Flow|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
10991342|NCT01009203|OG000|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
10991343|NCT01009203|EG000|Reported Event|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
10991344|NCT01009281|BG000|Baseline|Secukinumab|Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
10991345|NCT01009281|FG000|Participant Flow|Secukinumab|Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
10991346|NCT01009281|OG000|Outcome|Secukinumab|Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
10991347|NCT01009281|EG000|Reported Event|Secukinumab|Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
10991348|NCT01009333|BG000|Baseline|All Study Participants|
10991349|NCT01009333|FG000|Participant Flow|Start at 5.2 Hz, Then 14 Hz, Then 25 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to Medium InterStim Rate Setting at 14 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
10991350|NCT01009333|FG001|Participant Flow|Start at 5.2 Hz, Then 25 Hz, Then 14 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to High InterStim Rate Setting at 25 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
10991351|NCT01009333|FG002|Participant Flow|Start at 14 Hz, Then 5.2 Hz, Then 25 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
10991352|NCT01009333|FG003|Participant Flow|Start at 14 Hz, Then 25 Hz, Then 5.2 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to High InterStim Rate setting at 25 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
10991353|NCT01009333|FG004|Participant Flow|Start at 25 Hz, Then 5.2 Hz, Then 14 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
10991354|NCT01009333|FG005|Participant Flow|Start at 25 Hz, Then 14 Hz, Then 5.2 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Medium InterStim Rate setting at 14 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
10991355|NCT01009333|OG000|Outcome|Low InterStim Rate Setting at 5.2 Hz|
10991356|NCT01009333|OG001|Outcome|Medium InterStim Rate Setting at 14 Hz|
10991357|NCT01009333|OG002|Outcome|High InterStim Rate Setting at 25 Hz|
10991358|NCT01009333|EG000|Reported Event|Low InterStim Rate Setting at 5.2 Hz|
10991359|NCT01009333|EG001|Reported Event|Medium InterStim Rate Setting at 14 Hz|
10991360|NCT01009333|EG002|Reported Event|High InterStim Rate Setting at 25 Hz|
10991361|NCT01009346|BG000|Baseline|Study Arm|"Drug: RAD001~Other Names:~Everolimus~Dose Level -1 2.5mg/day~Dose Level 1 5mg/day*~Dose Level 2 10mg/day~MTD RAD001 Drug: Cetuximab~Other Names:~Erbitux~250mg/m2/week Drug: Cisplatin~Other Names:~cisplatinum CDDP cis-diamminedichloroplatinum(II)~40mg/m2 Day 1, 8 every 28 days Drug: Carboplatin~Other Names:~cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)~Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:~Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance."
10991362|NCT01009346|FG000|Participant Flow|RAD001|Daily RAD001 in combination with weekly cetuximab and cisplatin/ carboplatin on Day 1, 8 of each 28 day cycle.
11348214|NCT04196907|OG000|Outcome|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin."
10991363|NCT01009346|OG000|Outcome|Study Arm (RAD001, Cetuximab, Cisplatin or Carboplatin)|Phase I will be a single arm , dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
10991364|NCT01009346|OG000|Outcome|Study Arm (RAD001)|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
10991365|NCT01009346|EG000|Reported Event|RAD001/Cetuximab/Cisplatin or Carboplatin|This was a dose escalation study with RAD001 in combination with cetuximab and cisplatin in recurrent/metastatic SCCHN. Patients with ECOG performance status 0-2, with no prior systemic therapy for recurrent/metastatic SCCHN were enrolled. The dose levels for RAD001 were 2.5mg, 5mg or 10 mg administered oral daily, cetuximab 250mg/m2 weekly infusion, and cisplatin 40mg/m2 days 1 and 8. Each cycle was 28 days. Safety monitoring plan was outlined in the protocol and study calendar at specific time points. Response was evaluated with CT/MRI and PET scans every 2 cycles. DLT criteria and MTD was defined.
10991366|NCT01009463|BG000|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991367|NCT01009463|BG001|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
11348215|NCT04196907|EG000|Reported Event|Test Subjects|"All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin.~Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin."
11348216|NCT04195893|BG000|Baseline|Overall Study|Total Participants
10991368|NCT01009463|BG002|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991369|NCT01009463|BG003|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991370|NCT01009463|BG004|Baseline|Total|Total of all reporting groups
10991371|NCT01009463|FG000|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
10991372|NCT01009463|FG001|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991373|NCT01009463|FG002|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991374|NCT01009463|FG003|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991375|NCT01009463|FG004|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10846475|NCT00276380|EG001|Reported Event|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
10991376|NCT01009463|OG000|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991377|NCT01009463|OG001|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991378|NCT01009463|OG002|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991379|NCT01009463|OG003|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991380|NCT01009463|OG000|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. )
10991381|NCT01009463|EG000|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991382|NCT01009463|EG001|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991383|NCT01009463|EG002|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991384|NCT01009463|EG003|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10991385|NCT01009515|BG000|Baseline|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
10991386|NCT01009515|FG000|Participant Flow|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
10991387|NCT01009515|OG000|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
10991388|NCT01009515|EG000|Reported Event|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
10991389|NCT01009554|BG000|Baseline|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
10991390|NCT01009554|BG001|Baseline|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
10991391|NCT01009554|BG002|Baseline|Total|Total of all reporting groups
10991392|NCT01009554|FG000|Participant Flow|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
10991393|NCT01009554|FG001|Participant Flow|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
10991394|NCT01009554|OG000|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
10991395|NCT01009554|OG001|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
10991396|NCT01009554|EG000|Reported Event|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
10991397|NCT01009554|EG001|Reported Event|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
10991398|NCT01009580|BG000|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
10991399|NCT01009580|BG001|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
10991400|NCT01009580|BG002|Baseline|Total|Total of all reporting groups
10991401|NCT01009580|FG000|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
10991402|NCT01009580|FG001|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
10991403|NCT01009580|OG000|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
10991404|NCT01009580|OG001|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
10991405|NCT01009580|EG000|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
10991406|NCT01009580|EG001|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
10991407|NCT01009619|BG000|Baseline|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
10991408|NCT01009619|BG001|Baseline|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
10991409|NCT01009619|BG002|Baseline|Total|Total of all reporting groups
10991410|NCT01009619|FG000|Participant Flow|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
10991411|NCT01009619|FG001|Participant Flow|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
10991412|NCT01009619|OG000|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
10991413|NCT01009619|OG001|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
10991414|NCT01009619|EG000|Reported Event|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
10991415|NCT01009619|EG001|Reported Event|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
10991416|NCT01009645|BG000|Baseline|Fact Only|The educational message used will contain facts only.
10991417|NCT01009645|BG001|Baseline|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
10991418|NCT01009645|BG002|Baseline|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
10991419|NCT01009645|BG003|Baseline|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
10991420|NCT01009645|BG004|Baseline|Total|Total of all reporting groups
10991421|NCT01009645|FG000|Participant Flow|Fact Only|The educational message used will contain facts only.
10991422|NCT01009645|FG001|Participant Flow|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
10991423|NCT01009645|FG002|Participant Flow|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
10991424|NCT01009645|FG003|Participant Flow|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
10991425|NCT01009645|OG000|Outcome|Fact Only|The educational message used will contain facts only.
10991426|NCT01009645|OG001|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
10991427|NCT01009645|OG002|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
10991428|NCT01009645|OG003|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
10991429|NCT01009645|EG000|Reported Event|Fact Only|The educational message used will contain facts only.
10991430|NCT01009645|EG001|Reported Event|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
10991431|NCT01009645|EG002|Reported Event|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
10991432|NCT01009645|EG003|Reported Event|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
11007385|NCT01090453|EG001|Reported Event|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
11007386|NCT01090479|BG000|Baseline|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
11007387|NCT01090479|BG001|Baseline|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
11007388|NCT01090479|BG002|Baseline|Total|Total of all reporting groups
11007389|NCT01090479|FG000|Participant Flow|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
11007390|NCT01090479|FG001|Participant Flow|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
11007391|NCT01090479|OG000|Outcome|Control|
11007392|NCT01090479|OG001|Outcome|Chlorhexidine|
11007393|NCT01090479|EG000|Reported Event|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
11007394|NCT01090479|EG001|Reported Event|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
11007395|NCT01090492|BG000|Baseline|PRP Cohort: Placebo First, Then PF-00489791 4 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007396|NCT01090492|BG001|Baseline|PRP Cohort: PF-00489791 4mg First, Then Placebo|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention DB period and 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007397|NCT01090492|BG002|Baseline|PRP Cohort: Placebo First, Then PF-00489791 20 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007398|NCT01090492|BG003|Baseline|PRP Cohort: PF-00489791 20 mg First, Then Placebo|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007399|NCT01090492|BG004|Baseline|SRP Cohort: Placebo First, Then PF-00489791 4 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007400|NCT01090492|BG005|Baseline|SRP Cohort: PF-00489791 4 mg First, Then Placebo|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007401|NCT01090492|BG006|Baseline|SRP Cohort: Placebo First, Then PF-00489791 20 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007402|NCT01090492|BG007|Baseline|SRP Cohort: PF-00489791 20 mg First, Then Placebo|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007403|NCT01090492|BG008|Baseline|Total|Total of all reporting groups
11007404|NCT01090492|FG000|Participant Flow|PRP Cohort: Placebo First, Then PF-00489791 4 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11223232|NCT02352259|EG000|Reported Event|Electrochemotherapy|All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
10991433|NCT01009762|BG000|Baseline|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
10991434|NCT01009762|BG001|Baseline|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
10991435|NCT01009762|BG002|Baseline|Total|Total of all reporting groups
10991436|NCT01009762|FG000|Participant Flow|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
10991437|NCT01009762|FG001|Participant Flow|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
10991438|NCT01009762|OG000|Outcome|Vaccinee|participants receiving the vaccine
10991439|NCT01009762|OG001|Outcome|Placebo|participants receiving placebo (=saline)
10991440|NCT01009762|OG000|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
10991441|NCT01009762|OG001|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
10991442|NCT01009762|EG000|Reported Event|Vaccinee|"participants receiving the vaccine called AFO-18"
10991443|NCT01009762|EG001|Reported Event|Placebo|Participants receiving placebo (saline)
10991444|NCT01009814|BG000|Baseline|BMS-663068 600 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
10991445|NCT01009814|BG001|Baseline|BMS-663068 1200 mg QHS + RTV 100 mg QHS|All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
10991446|NCT01009814|BG002|Baseline|BMS-663068 1200 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
10991447|NCT01009814|BG003|Baseline|BMS-663068 1200 mg Q12H + RTV 100 mg QAM|All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
10991448|NCT01009814|BG004|Baseline|BMS-663068 1200 mg Q12H|All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
10991449|NCT01009814|BG005|Baseline|Total|Total of all reporting groups
10991450|NCT01009814|FG000|Participant Flow|BMS-663068 600 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
10991451|NCT01009814|FG001|Participant Flow|BMS-663068 1200 mg QHS + RTV 100 mg QHS|All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
10991452|NCT01009814|FG002|Participant Flow|BMS-663068 1200 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
10991453|NCT01009814|FG003|Participant Flow|BMS-663068 1200 mg Q12H + RTV 100 mg QAM|All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
10991454|NCT01009814|FG004|Participant Flow|BMS-663068 1200 mg Q12H|All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
10991455|NCT01009814|OG000|Outcome|BMS-663068 600 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
10991456|NCT01009814|OG001|Outcome|BMS-663068 1200 mg QHS + RTV 100 mg QHS|All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
10991457|NCT01009814|OG002|Outcome|BMS-663068 1200 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
10991458|NCT01009814|OG003|Outcome|BMS-663068 1200 mg Q12H + RTV 100 mg QAM|All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
10991459|NCT01009814|OG004|Outcome|BMS-663068 1200 mg Q12H|All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
10991460|NCT01009814|OG001|Outcome|BMS-663068 1200 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
10991461|NCT01009814|OG002|Outcome|BMS-663068 1200 mg Q12H + RTV 100 mg QAM|All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
10991462|NCT01009814|OG003|Outcome|BMS-663068 1200 mg Q12H|All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
10991463|NCT01009814|OG000|Outcome|BMS-663068 1200 mg QHS + RTV 100 mg QHS|All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
10991464|NCT01009814|EG000|Reported Event|BMS-663068 600 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.
10991465|NCT01009814|EG001|Reported Event|BMS-663068 1200 mg QHS + RTV 100 mg QHS|All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni [QHS]) from Day 1 to Day 8.
10991466|NCT01009814|EG002|Reported Event|BMS-663068 1200 mg Q12H + RTV 100 mg Q12H|All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.
10991467|NCT01009814|EG003|Reported Event|BMS-663068 1200 mg Q12H + RTV 100 mg QAM|All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem [QAM]) from Day 1 to Day 8.
10991468|NCT01009814|EG004|Reported Event|BMS-663068 1200 mg Q12H|All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
10991469|NCT01009840|BG000|Baseline|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
10991470|NCT01009840|FG000|Participant Flow|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the pharmacokinetic (PK)-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to hematopoietic stem cell transplant (HSCT).
10991471|NCT01009840|OG000|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
10991472|NCT01009840|EG000|Reported Event|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
10991473|NCT01009918|BG000|Baseline|Arm I Lisinopril|"Patients receive oral lisinopril once daily.~lisinopril: Given orally"
10991474|NCT01009918|BG001|Baseline|Arm II Coreg CR®|"Patients receive oral Coreg CR® once daily.~Coreg CR®: Given orally"
10991475|NCT01009918|BG002|Baseline|Arm III Placebo|"Patients receive oral placebo once daily.~placebo: Given orally"
10991476|NCT01009918|BG003|Baseline|Total|Total of all reporting groups
10991477|NCT01009918|FG000|Participant Flow|Arm I Lisinopril|"Patients receive oral lisinopril once daily.~lisinopril: Given orally"
10991478|NCT01009918|FG001|Participant Flow|Arm II Coreg CR®|"Patients receive oral Coreg CR® once daily.~Coreg CR®: Given orally"
10991479|NCT01009918|FG002|Participant Flow|Arm III Placebo|"Patients receive oral placebo once daily.~placebo: Given orally"
10991480|NCT01009918|OG000|Outcome|Arm I Lisinopril|"Patients receive oral lisinopril once daily.~lisinopril: Given orally"
10991481|NCT01009918|OG001|Outcome|Arm II Coreg CR®|"Patients receive oral Coreg CR® once daily.~Coreg CR®: Given orally"
10991482|NCT01009918|OG002|Outcome|Arm III Placebo|"Patients receive oral placebo once daily.~placebo: Given orally"
10991483|NCT01009918|EG000|Reported Event|Arm I Lisinopril|"Patients receive oral lisinopril once daily.~lisinopril: Given orally"
10991484|NCT01009918|EG001|Reported Event|Arm II Coreg CR®|"Patients receive oral Coreg CR® once daily.~Coreg CR®: Given orally"
10991485|NCT01009918|EG002|Reported Event|Arm III Placebo|"Patients receive oral placebo once daily.~placebo: Given orally"
10991486|NCT01009983|BG000|Baseline|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
10991487|NCT01009983|FG000|Participant Flow|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
10991488|NCT01009983|OG000|Outcome|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
10991489|NCT01009983|EG000|Reported Event|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
10991490|NCT01010009|BG000|Baseline|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
10991491|NCT01010009|BG001|Baseline|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
10991492|NCT01010009|BG002|Baseline|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
10991493|NCT01010009|BG003|Baseline|Total|Total of all reporting groups
10991494|NCT01010009|FG000|Participant Flow|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
10991495|NCT01010009|FG001|Participant Flow|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
10991496|NCT01010009|FG002|Participant Flow|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
10991497|NCT01010009|OG000|Outcome|Resveratrol 250mg|
10991498|NCT01010009|OG001|Outcome|Resveratrol 500mg|
10991499|NCT01010009|OG002|Outcome|Placebo|
10991500|NCT01010009|EG000|Reported Event|Resveratrol 250mg|
10991501|NCT01010009|EG001|Reported Event|Resveratrol 500mg|
10991502|NCT01010009|EG002|Reported Event|Placebo|
10991503|NCT01010061|BG000|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
10991504|NCT01010061|BG001|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
10991505|NCT01010061|BG002|Baseline|Total|Total of all reporting groups
10991506|NCT01010061|FG000|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
10991507|NCT01010061|FG001|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
10991508|NCT01010061|OG000|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
10991509|NCT01010061|OG001|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
10991510|NCT01010061|OG000|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
11223233|NCT02352298|BG000|Baseline|Dario and Yellow Springs Instrument|Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System and the Yellow Springs Instrument for comparison.
10991511|NCT01010061|EG000|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
10991512|NCT01010061|EG001|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
10991513|NCT01010061|EG002|Reported Event|Crossover Subjects: Obinutuzumab + Chlorambucil (GClb)|Subjects in Clb arm who progressed during/within 6 months after end of Clb treatment had opportunity to cross over to GClb arm at discretion of investigator. Subjects received 1000 mg obinutuzumab IV infusion, on Day 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 milligram per kilogram of body weight (mg/kg) orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
10991514|NCT01010126|BG000|Baseline|Endometrial Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991515|NCT01010126|BG001|Baseline|Ovarian Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991516|NCT01010126|BG002|Baseline|Hepatocellular Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991517|NCT01010126|BG003|Baseline|Carcinoid Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991518|NCT01010126|BG004|Baseline|Islet Cell (Double Agent) Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991519|NCT01010126|BG005|Baseline|Islet Cell (Bevacizumab-only) Cohort|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991520|NCT01010126|BG006|Baseline|Total|Total of all reporting groups
10991521|NCT01010126|FG000|Participant Flow|Endometrial Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991522|NCT01010126|FG001|Participant Flow|Ovarian Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991523|NCT01010126|FG002|Participant Flow|Hepatocellular Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991524|NCT01010126|FG003|Participant Flow|Carcinoid Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991525|NCT01010126|FG004|Participant Flow|Islet Cell (Double Agent) Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991526|NCT01010126|FG005|Participant Flow|Islet Cell (Bevacizumab-only) Cohort|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991527|NCT01010126|OG000|Outcome|Endometrial Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991528|NCT01010126|OG001|Outcome|Ovarian Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991529|NCT01010126|OG002|Outcome|Hepatocellular Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991530|NCT01010126|OG003|Outcome|Carcinoid Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991531|NCT01010126|OG004|Outcome|Islet Cell (Double Agent) Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991532|NCT01010126|OG005|Outcome|Islet Cell (Bevacizumab-only) Cohort|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991533|NCT01010126|EG000|Reported Event|Endometrial Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991534|NCT01010126|EG001|Reported Event|Ovarian Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991535|NCT01010126|EG002|Reported Event|Hepatocellular Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991536|NCT01010126|EG003|Reported Event|Carcinoid Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991537|NCT01010126|EG004|Reported Event|Islet Cell (Double Agent) Cohort|Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991538|NCT01010126|EG005|Reported Event|Islet Cell (Bevacizumab-only) Cohort|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10991539|NCT01010204|BG000|Baseline|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
10991540|NCT01010204|BG001|Baseline|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
10991541|NCT01010204|BG002|Baseline|Total|Total of all reporting groups
10991542|NCT01010204|FG000|Participant Flow|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
10991543|NCT01010204|FG001|Participant Flow|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
10991544|NCT01010204|OG000|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
10991545|NCT01010204|OG001|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
10991546|NCT01010204|EG000|Reported Event|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
10991547|NCT01010204|EG001|Reported Event|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
10991548|NCT01010217|BG000|Baseline|Haplo Arm|Patients that received a transplant from a haploindentical donor
10991549|NCT01010217|BG001|Baseline|1AgMM Related/Unrelated Donors|Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
10991550|NCT01010217|BG002|Baseline|MUD Donor|Patients that received a transplant from a matched unrelated donor
10991551|NCT01010217|BG003|Baseline|Second Transplant|Patients receiving a second transplant
10991552|NCT01010217|BG004|Baseline|Myelofibrosis|Patients with the diagnosis of Myelofibrosis
10991553|NCT01010217|BG005|Baseline|Total|Total of all reporting groups
10991554|NCT01010217|FG000|Participant Flow|Haplo Arm|Patients that received a stem cell transplant from a haploidentical donor.
10991555|NCT01010217|FG001|Participant Flow|1AgMM Related/Unrelated Donors|Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
10991556|NCT01010217|FG002|Participant Flow|MUD Donor|Patients that received a transplant from a matched unrelated donor
10991557|NCT01010217|FG003|Participant Flow|Second Transplant|Patients receiving a second transplant
10991558|NCT01010217|FG004|Participant Flow|Myelofibrosis|Patients with the diagnosis of Myelofibrosis
10991559|NCT01010217|OG000|Outcome|Haplo Arm|Patients that received a transplant from a haploidentical donor
10991560|NCT01010217|OG001|Outcome|1AgMM Related/Unrelated Donors|Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
10991561|NCT01010217|OG002|Outcome|MUD Donor|Patients that received a transplant from a matched unrelated donor
10991562|NCT01010217|OG003|Outcome|Second Transplant|Patients receiving a second transplant
10991563|NCT01010217|OG004|Outcome|Myelofibrosis|Patients with the diagnosis of Myelofibrosis
10991564|NCT01010217|EG000|Reported Event|Haplo Arm|Patients that received a transplant from a haploindentical donor
10991565|NCT01010217|EG001|Reported Event|1AgMM Related/Unrelated Donors|Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
10991566|NCT01010217|EG002|Reported Event|MUD Donor|Patients that received a transplant from a matched unrelated donor
10991567|NCT01010217|EG003|Reported Event|Second Transplant|Patients receiving a second transplant
10991568|NCT01010217|EG004|Reported Event|Myelofibrosis|Patients with the diagnosis of Myelofibrosis
10991569|NCT01010230|BG000|Baseline|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
10991570|NCT01010230|BG001|Baseline|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
10991571|NCT01010230|BG002|Baseline|Total|Total of all reporting groups
10991572|NCT01010230|FG000|Participant Flow|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
10991573|NCT01010230|FG001|Participant Flow|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
10991574|NCT01010230|OG000|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
10991575|NCT01010230|OG001|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
10991576|NCT01010230|EG000|Reported Event|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
10991577|NCT01010230|EG001|Reported Event|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
10991578|NCT01010282|BG000|Baseline|Artificial Tears Formulation 1|Artificial Tears Formulation 1
10991579|NCT01010282|BG001|Baseline|Artificial Tears Formulation 2|Artificial Tears Formulation 2
10991580|NCT01010282|BG002|Baseline|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
10991581|NCT01010282|BG003|Baseline|Total|Total of all reporting groups
10991582|NCT01010282|FG000|Participant Flow|Artificial Tears Formulation 1|Artificial Tears Formulation 1
10991583|NCT01010282|FG001|Participant Flow|Artificial Tears Formulation 2|Artificial Tears Formulation 2
10991584|NCT01010282|FG002|Participant Flow|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
10991585|NCT01010282|OG000|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
10991586|NCT01010282|OG001|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
10991587|NCT01010282|OG002|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
10991588|NCT01010282|EG000|Reported Event|Artificial Tears Formulation 1|Artificial Tears Formulation 1
10991589|NCT01010282|EG001|Reported Event|Artificial Tears Formulation 2|Artificial Tears Formulation 2
10991590|NCT01010282|EG002|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
10991591|NCT01010399|BG000|Baseline|Boosted Lexiva With Lovaza|
10991592|NCT01010399|FG000|Participant Flow|Boosted Lexiva With Lovaza|
10991593|NCT01010399|OG000|Outcome|Boosted Lexiva With Lovaza|
10991594|NCT01010399|EG000|Reported Event|Boosted Lexiva With Lovaza|
10991595|NCT01010477|BG000|Baseline|NNS Active|Receives nicotine (active) nasal spray
10991596|NCT01010477|BG001|Baseline|Placebo NS|Receives placebo (piperine containing) nasal spray
10991597|NCT01010477|BG002|Baseline|Total|Total of all reporting groups
10991598|NCT01010477|FG000|Participant Flow|NNS Active|Receives active nicotine containing Nasal spray
10991599|NCT01010477|FG001|Participant Flow|Placebo|Receives placebo (piperine)nasal spray
10991600|NCT01010477|OG000|Outcome|NNS Active|Receives nicotine (active ) nasal spray
10991601|NCT01010477|OG001|Outcome|Placebo|Receives placebo (piperine)nasal spray
10991602|NCT01010477|EG000|Reported Event|NNS Active|Receives nicotine (active) nasal spray
10991603|NCT01010477|EG001|Reported Event|Placebo|Receives placebo (piperine)nasal spray
10991604|NCT01010503|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
10991605|NCT01010503|FG000|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
10991606|NCT01010503|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
10991607|NCT01010503|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
10991608|NCT01010555|BG000|Baseline|Overall|This reporting group includes all enrolled subjects.
10991609|NCT01010555|FG000|Participant Flow|Lotrafilcon B/Balafilcon A, Then Senofilcon A/Enfilcon A|Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
10991610|NCT01010555|FG001|Participant Flow|Senofilcon A/Enfilcon A, Then Lotrafilcon b/Balafilcon A|Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
10991611|NCT01010555|OG000|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
10991612|NCT01010555|OG001|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
10991613|NCT01010555|OG002|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
10991614|NCT01010555|OG003|Outcome|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
10991615|NCT01010555|EG000|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
10991616|NCT01010555|EG001|Reported Event|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
10991617|NCT01010555|EG002|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
10991618|NCT01010555|EG003|Reported Event|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
10991619|NCT01010568|BG000|Baseline|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
10991620|NCT01010568|FG000|Participant Flow|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
10991621|NCT01010568|OG000|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
10991622|NCT01010568|OG000|Outcome|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
10991623|NCT01010568|EG000|Reported Event|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
10991624|NCT01010633|BG000|Baseline|Loteprednol|Loteprednol etabonate 0.5%
10991625|NCT01010633|BG001|Baseline|Vehicle|Vehicle of loteprednol etabonate
10991626|NCT01010633|BG002|Baseline|Total|Total of all reporting groups
10991627|NCT01010633|FG000|Participant Flow|Loteprednol|Loteprednol etabonate 0.5%
10991628|NCT01010633|FG001|Participant Flow|Vehicle|Vehicle of loteprednol etabonate
10991629|NCT01010633|OG000|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
10991630|NCT01010633|OG001|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
10991631|NCT01010633|EG000|Reported Event|Loteprednol|Loteprednol etabonate 0.5%
10991632|NCT01010633|EG001|Reported Event|Vehicle|Vehicle of loteprednol etabonate
10991633|NCT01010750|BG000|Baseline|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|
10991634|NCT01010750|BG001|Baseline|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|
10991635|NCT01010750|BG002|Baseline|Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg|
10991636|NCT01010750|BG003|Baseline|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|
10991637|NCT01010750|BG004|Baseline|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|
10991638|NCT01010750|BG005|Baseline|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|
10991639|NCT01010750|BG006|Baseline|Total|Total of all reporting groups
10991640|NCT01010750|FG000|Participant Flow|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo
10991641|NCT01010750|FG001|Participant Flow|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
10991642|NCT01010750|FG002|Participant Flow|Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg|LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
10991643|NCT01010750|FG003|Participant Flow|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo
10991644|NCT01010750|FG004|Participant Flow|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo
10991645|NCT01010750|FG005|Participant Flow|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo
10991646|NCT01010750|OG000|Outcome|LDX 50 mg|
10991647|NCT01010750|OG001|Outcome|MAS-IR 20 mg|
10991648|NCT01010750|OG002|Outcome|Placebo|
10991649|NCT01010750|EG000|Reported Event|LDX 50 mg|
10991650|NCT01010750|EG001|Reported Event|MAS-IR 20 mg|
10991651|NCT01010750|EG002|Reported Event|Placebo|
10991652|NCT01010763|BG000|Baseline|M2a Magnum|"Total HIp Arthroplasty using with the M2a Magnum Large Metal Articulation is an ultra-high performance metal-on-metal articulation with a big ball (greater than or equal to 38mm) in acetabulums as small as 44mm.~Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only)."
10991653|NCT01010763|BG001|Baseline|M2a Taper|"Total Hip Arthroplasty using with the M2a Taper Acetabular System consists of a titanium outer shell with cobalt chromium (Co-Cr-Mo) metallic liner, which articulates with with a cobalt chromium (Co-Cr-Mo) modular femoral head.~Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only)."
10991654|NCT01010763|BG002|Baseline|Total|Total of all reporting groups
10991655|NCT01010763|FG000|Participant Flow|M2a Magnum|"Total HIp Arthroplasty using with the M2a Magnum Large Metal Articulation is an ultra-high performance metal-on-metal articulation with a big ball (greater than or equal to 38mm) in acetabulums as small as 44mm.~Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only)."
10991656|NCT01010763|FG001|Participant Flow|M2a Taper|"Total Hip Arthroplasty using with the M2a Taper Acetabular System consists of a titanium outer shell with cobalt chromium (Co-Cr-Mo) metallic liner, which articulates with with a cobalt chromium (Co-Cr-Mo) modular femoral head.~Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only)."
10991657|NCT01010763|OG000|Outcome|M2a Magnum|"Total HIp Arthroplasty using with the M2a Magnum Large Metal Articulation is an ultra-high performance metal-on-metal articulation with a big ball (greater than or equal to 38mm) in acetabulums as small as 44mm.~Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only)."
10991658|NCT01010763|OG001|Outcome|M2a Taper|"Total Hip Arthroplasty using with the M2a Taper Acetabular System consists of a titanium outer shell with cobalt chromium (Co-Cr-Mo) metallic liner, which articulates with with a cobalt chromium (Co-Cr-Mo) modular femoral head.~Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only)."
10991659|NCT01010763|EG000|Reported Event|M2a Magnum|"Total HIp Arthroplasty using with the M2a Magnum Large Metal Articulation is an ultra-high performance metal-on-metal articulation with a big ball (greater than or equal to 38mm) in acetabulums as small as 44mm.~Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only)."
10991660|NCT01010763|EG001|Reported Event|M2a Taper|"Total Hip Arthroplasty using with the M2a Taper Acetabular System consists of a titanium outer shell with cobalt chromium (Co-Cr-Mo) metallic liner, which articulates with with a cobalt chromium (Co-Cr-Mo) modular femoral head.~Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only)."
10991661|NCT01010776|BG000|Baseline|Paliperidone ER - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991662|NCT01010776|FG000|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991663|NCT01010776|OG000|Outcome|Paliperidone Extended Release (ER) - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
10991664|NCT01010776|OG000|Outcome|Paliperidone (ER) - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991665|NCT01010776|OG000|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
10991666|NCT01010776|OG000|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991667|NCT01010776|OG000|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991668|NCT01010776|OG000|Outcome|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally, once daily for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991669|NCT01010776|OG000|Outcome|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
10991670|NCT01010776|OG000|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991671|NCT01010776|OG000|Outcome|Paliperidone ER- Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
10991672|NCT01010776|OG000|Outcome|Paliperidone ER - Main Phase|Single oral dose of paliperidone ER tablet within the range of 3 to 12 mg once a day was administered for 26 weeks. Dosage was adjusted as per the investigator's discretion.
10991673|NCT01010776|OG000|Outcome|Paliperidone ER-Main Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991674|NCT01010776|EG000|Reported Event|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
10991675|NCT01010776|EG001|Reported Event|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
10991676|NCT01010854|BG000|Baseline|VPA FEC100|"Valproic Acid with FEC100~VPA FEC100: oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
10991677|NCT01010854|FG000|Participant Flow|VPA FEC100|"Valproic Acid with FEC100~oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
10991678|NCT01010854|OG000|Outcome|VPA FEC100|"Valproic Acid with FEC100~oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
10991679|NCT01010854|EG000|Reported Event|VPA FEC100|"Valproic Acid with FEC100~oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
10991680|NCT01010867|BG000|Baseline|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
10991681|NCT01010867|FG000|Participant Flow|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C.~Colony forming units (CFU)"
10991682|NCT01010867|OG000|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
10991683|NCT01010867|EG000|Reported Event|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
10991684|NCT01010906|BG000|Baseline|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
10991685|NCT01010906|BG001|Baseline|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
10991686|NCT01010906|BG002|Baseline|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
10991687|NCT01010906|BG003|Baseline|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
10991688|NCT01010906|BG004|Baseline|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
10991689|NCT01010906|BG005|Baseline|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
10991690|NCT01010906|BG006|Baseline|Total|Total of all reporting groups
10991691|NCT01010906|FG000|Participant Flow|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
10991692|NCT01010906|FG001|Participant Flow|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
10991693|NCT01010906|FG002|Participant Flow|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
10991694|NCT01010906|FG003|Participant Flow|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
10991695|NCT01010906|FG004|Participant Flow|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
10991696|NCT01010906|FG005|Participant Flow|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
10991697|NCT01010906|OG000|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
10991698|NCT01010906|OG001|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
10991699|NCT01010906|OG002|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
10991700|NCT01010906|OG003|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
10991701|NCT01010906|OG004|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
10991702|NCT01010906|OG005|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
10991703|NCT01010906|EG000|Reported Event|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
10991704|NCT01010906|EG001|Reported Event|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
10991705|NCT01010906|EG002|Reported Event|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
10991706|NCT01010906|EG003|Reported Event|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
10991707|NCT01010906|EG004|Reported Event|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
10991708|NCT01010906|EG005|Reported Event|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
10991709|NCT01010932|BG000|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
10991710|NCT01010932|FG000|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
10991711|NCT01010932|OG000|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
10991712|NCT01010932|OG001|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
10991713|NCT01010932|EG000|Reported Event|Dotarem MRA|Patients benefiting from a MR angiography after an IV administration of Dotarem
10991714|NCT01010932|EG001|Reported Event|TOF MRA|Patients benefiting from a MR angiography with no contrast medium administration
10991715|NCT01010932|EG002|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium
10991716|NCT01010932|EG003|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn before administration of Dotarem whatever the reason
10991717|NCT01010971|BG000|Baseline|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
10991718|NCT01010971|BG001|Baseline|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
10991719|NCT01010971|BG002|Baseline|Placebo|Placebo once daily
10991720|NCT01010971|BG003|Baseline|Total|Total of all reporting groups
10991721|NCT01010971|FG000|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
10991722|NCT01010971|FG001|Participant Flow|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
10991723|NCT01010971|FG002|Participant Flow|Placebo|Placebo once daily
10991724|NCT01010971|OG000|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
10991725|NCT01010971|OG001|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
10991726|NCT01010971|OG002|Outcome|Placebo|Placebo once daily
10991727|NCT01010971|EG000|Reported Event|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
10991728|NCT01010971|EG001|Reported Event|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
10991729|NCT01010971|EG002|Reported Event|Placebo|Placebo once daily
10991730|NCT01010984|BG000|Baseline|Transcatheter Arterial Chemoembolization|"TACE using LC beads loaded with Doxorubicin~LC beads loaded with Doxorubicin: During each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads loaded with doxorubicin will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg"
10991731|NCT01010984|FG000|Participant Flow|Tace Using LC Beads Loaded With 150mg of Doxorubicin|Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.
10991732|NCT01010984|OG000|Outcome|Single Arm|Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.
10991733|NCT01010984|OG000|Outcome|Tace Using LC Beads Loaded With Doxorubicin|Tace using LC beads loaded with 150mg doxorubicin. Treatment repeats every 3-4 weeks. Two to three treatments may be had in each lobe of the liver.
10991734|NCT01010984|EG000|Reported Event|Single Arm|Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.
10991735|NCT01011049|BG000|Baseline|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
10991736|NCT01011049|BG001|Baseline|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
10991737|NCT01011049|BG002|Baseline|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
10991738|NCT01011049|BG003|Baseline|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
10991739|NCT01011049|BG004|Baseline|Total|Total of all reporting groups
10991740|NCT01011049|FG000|Participant Flow|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
10991741|NCT01011049|FG001|Participant Flow|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
10991742|NCT01011049|FG002|Participant Flow|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
10991743|NCT01011049|FG003|Participant Flow|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
10991744|NCT01011049|OG000|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
10991745|NCT01011049|OG001|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
10991746|NCT01011049|OG002|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
10991747|NCT01011049|OG003|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
10991748|NCT01011049|EG000|Reported Event|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
10991749|NCT01011049|EG001|Reported Event|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
10991750|NCT01011049|EG002|Reported Event|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
10991751|NCT01011049|EG003|Reported Event|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
10991752|NCT01011075|BG000|Baseline|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
10991753|NCT01011075|FG000|Participant Flow|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
10991754|NCT01011075|OG000|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
10991755|NCT01011075|EG000|Reported Event|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
10991756|NCT01011153|BG000|Baseline|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
10991757|NCT01011153|BG001|Baseline|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
10991758|NCT01011153|BG002|Baseline|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
10846476|NCT00276406|BG000|Baseline|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
10991759|NCT01011153|BG003|Baseline|Total|Total of all reporting groups
10991760|NCT01011153|FG000|Participant Flow|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
10991761|NCT01011153|FG001|Participant Flow|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
10991762|NCT01011153|FG002|Participant Flow|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
10991763|NCT01011153|OG000|Outcome|Dermatologists|Dermatologists were defined as board-certified dermatologists who were General Dermatologists and Pigmented Skin Lesion Experts, according to the Intake Survey. Dermatologists in this group did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consistinf of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
10991764|NCT01011153|OG001|Outcome|MelaFind|MelaFind imaged 130 cases which consisted of 65 positive cases (i.e., histolgoically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
10991765|NCT01011153|OG000|Outcome|General Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
10991766|NCT01011153|OG001|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
10991767|NCT01011153|OG002|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
10991768|NCT01011153|OG003|Outcome|MelaFind|MelaFind imaged the 130 cases, the 65 positive cases (i.e., histologically confirmed melanoma) and the 65 negative cases (i.e., histologically confirmed non-melanoma). Sensitivity was calculated based on the correct identification of the 65 positive cases and specificity was calculated based on the correct identification of the 65 negative cases.
10991769|NCT01011153|OG000|Outcome|Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
10991770|NCT01011153|OG003|Outcome|All Partipants|All Participants are the General Dermatologists, Pigmented Skin Lesion Experts and Primary Care Physicians combined.
10991771|NCT01011153|OG000|Outcome|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
10991772|NCT01011153|OG001|Outcome|Pigmented Skin Lesion Experts|
10991773|NCT01011153|OG002|Outcome|Primary Care Physicians|
10991774|NCT01011153|EG000|Reported Event|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
10991775|NCT01011153|EG001|Reported Event|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
10991776|NCT01011153|EG002|Reported Event|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
10991777|NCT01011179|BG000|Baseline|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
10991778|NCT01011179|BG001|Baseline|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
10991779|NCT01011179|BG002|Baseline|Total|Total of all reporting groups
10991780|NCT01011179|FG000|Participant Flow|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
10991781|NCT01011179|FG001|Participant Flow|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
10991782|NCT01011179|OG000|Outcome|Internet-based JIA Self-Management Program|Teens Taking Charge: The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
10991783|NCT01011179|OG001|Outcome|Attention Control Group|"Self-Management: Adolescents' own best efforts at managing their JIA"
10991784|NCT01011179|OG000|Outcome|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
11223234|NCT02352298|FG000|Participant Flow|Dario and Yellow Springs Instrument|Blood is obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System, blood glucose level is then also analyzed on the Yellow Springs Instrument for comparison.
10991785|NCT01011179|OG001|Outcome|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
10991786|NCT01011179|EG000|Reported Event|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
10991787|NCT01011179|EG001|Reported Event|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
10991788|NCT01011218|BG000|Baseline|BBT-I + Armodafinil|"Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.~Armodafinil 150 mg/day by mouth.~BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone~Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil."
10991789|NCT01011218|BG001|Baseline|Behavioral Placebo + Armodafinil|"Control behavioral intervention is a sleep hygiene handout completed by participant.~Armodafinil 150 mg/day by mouth.~Control: Control behavioral intervention is a sleep hygiene handout completed by participant.~Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil."
10991790|NCT01011218|BG002|Baseline|BBT-I Without Armodafinil|"Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.~No pharmaceutical intervention.~BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone"
10991791|NCT01011218|BG003|Baseline|Behavioral Placebo Without Armodafinil|"Control behavioral intervention is a sleep hygiene handout completed by participant.~No pharmaceutical intervention.~Control: Control behavioral intervention is a sleep hygiene handout completed by participant."
10991792|NCT01011218|BG004|Baseline|Total|Total of all reporting groups
10991793|NCT01011218|FG000|Participant Flow|BBT-I + Armodafinil|"Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.~Armodafinil 150 mg/day by mouth.~BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone~Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil."
10991794|NCT01011218|FG001|Participant Flow|Behavioral Placebo + Armodafinil|"Control behavioral intervention is a sleep hygiene handout completed by participant.~Armodafinil 150 mg/day by mouth.~Control: Control behavioral intervention is a sleep hygiene handout completed by participant.~Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil."
10991795|NCT01011218|FG002|Participant Flow|BBT-I Without Armodafinil|"Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.~No pharmaceutical intervention.~BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone"
10991796|NCT01011218|FG003|Participant Flow|Behavioral Placebo Without Armodafinil|"Control behavioral intervention is a sleep hygiene handout completed by participant.~No pharmaceutical intervention.~Control: Control behavioral intervention is a sleep hygiene handout completed by participant."
10991797|NCT01011218|OG000|Outcome|BBT-I + Armodafinil|"Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.~Armodafinil 150 mg/day by mouth.~BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone~Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil."
10991798|NCT01011218|OG001|Outcome|Behavioral Placebo + Armodafinil|"Control behavioral intervention is a sleep hygiene handout completed by participant.~Armodafinil 150 mg/day by mouth.~Control: Control behavioral intervention is a sleep hygiene handout completed by participant.~Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil."
10991799|NCT01011218|OG002|Outcome|BBT-I Without Armodafinil|"Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.~No pharmaceutical intervention.~BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone"
10991800|NCT01011218|OG003|Outcome|Behavioral Placebo Without Armodafinil|"Control behavioral intervention is a sleep hygiene handout completed by participant.~No pharmaceutical intervention.~Control: Control behavioral intervention is a sleep hygiene handout completed by participant."
10846477|NCT00276406|BG001|Baseline|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
10991801|NCT01011218|EG000|Reported Event|BBT-I + Armodafinil|"Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.~Armodafinil 150 mg/day by mouth.~BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone~Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil."
11223235|NCT02352298|OG000|Outcome|Dario Blood Glucose Monitoring System|"Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System~Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS"
10846478|NCT00276406|BG002|Baseline|Total|Total of all reporting groups
10991802|NCT01011218|EG001|Reported Event|Behavioral Placebo + Armodafinil|"Control behavioral intervention is a sleep hygiene handout completed by participant.~Armodafinil 150 mg/day by mouth.~Control: Control behavioral intervention is a sleep hygiene handout completed by participant.~Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil."
10991803|NCT01011218|EG002|Reported Event|BBT-I Without Armodafinil|"Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.~No pharmaceutical intervention.~BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone"
10991804|NCT01011218|EG003|Reported Event|Behavioral Placebo Without Armodafinil|"Control behavioral intervention is a sleep hygiene handout completed by participant.~No pharmaceutical intervention.~Control: Control behavioral intervention is a sleep hygiene handout completed by participant."
10991805|NCT01011283|BG000|Baseline|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
10991806|NCT01011283|BG001|Baseline|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
10991807|NCT01011283|BG002|Baseline|Total|Total of all reporting groups
10991808|NCT01011283|FG000|Participant Flow|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
10991809|NCT01011283|FG001|Participant Flow|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
10991810|NCT01011283|OG000|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
10991811|NCT01011283|OG001|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
10991812|NCT01011283|EG000|Reported Event|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
10991813|NCT01011283|EG001|Reported Event|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
10991814|NCT01011309|BG000|Baseline|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
10991815|NCT01011309|BG001|Baseline|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
10991816|NCT01011309|BG002|Baseline|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
10991817|NCT01011309|BG003|Baseline|Total|Total of all reporting groups
10991818|NCT01011309|FG000|Participant Flow|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
10991819|NCT01011309|FG001|Participant Flow|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
10991820|NCT01011309|FG002|Participant Flow|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
10991821|NCT01011309|OG000|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
10991822|NCT01011309|OG001|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
10991823|NCT01011309|OG002|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
10991824|NCT01011309|EG000|Reported Event|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
10991825|NCT01011309|EG001|Reported Event|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
10991826|NCT01011309|EG002|Reported Event|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
10991827|NCT01011335|BG000|Baseline|Monovalent rAT Doses|Monovalent rAT : 10, 25, 50 or 100 μg
10991828|NCT01011335|BG001|Baseline|Monovalent rLukS-PV Doses|Monovalent rLukS-PV : 10, 25, 50 or 100 μg
10991829|NCT01011335|BG002|Baseline|Bivalent rAT/rLukS-PV Doses|Bivalent rLukS-PV / rAT : 10, 25 or 50 μg
10991830|NCT01011335|BG003|Baseline|Placebo Doses|Saline placebo or alum placebo
10991831|NCT01011335|BG004|Baseline|Total|Total of all reporting groups
10991832|NCT01011335|FG000|Participant Flow|Monovalent rAT 10 ug Dose|Intramuscular; Monovalent rAT : 10 μg; single timepoint
10991833|NCT01011335|FG001|Participant Flow|Monovalent rAT 25 ug Dose|Intramuscular; Monovalent rAT : 25 μg; single timepoint
10991834|NCT01011335|FG002|Participant Flow|Monovalent rAT 50 ug Dose|Intramuscular; Monovalent rAT : 50 μg; single timepoint
10991835|NCT01011335|FG003|Participant Flow|Monovalent rAT 100 ug Dose|Intramuscular; Monovalent rAT : 100 μg; single timepoint
10991836|NCT01011335|FG004|Participant Flow|Monovalent rLukS 10 ug Dose|Intramuscular; Monovalent rLukS-PV : 10 μg; single timepoint
10991837|NCT01011335|FG005|Participant Flow|Monovalent rLukS 25 ug Dose|Intramuscular; Monovalent rLukS-PV : 25 μg; single timepoint
10991838|NCT01011335|FG006|Participant Flow|Monovalent rLukS 50 ug Dose|Intramuscular; Monovalent rLukS-PV : 50 μg; single timepoint
10991839|NCT01011335|FG007|Participant Flow|Monovalent rLukS 100 ug Dose|Intramuscular; Monovalent rLukS-PV : 100 μg; single timepoint
10991840|NCT01011335|FG008|Participant Flow|Bivalent rAT/rLukS 10 ug Dose|Intramuscular; Bivalent rAT/rLukS : 10 μg; single timepoint
10991841|NCT01011335|FG009|Participant Flow|Bivalent rAT/rLukS 25 ug Dose|Intramuscular; Bivalent rAT/rLukS : 25 μg; single timepoint
10991842|NCT01011335|FG010|Participant Flow|Bivalent rAT/rLukS 50 ug Dose|Intramuscular; Bivalent rAT/rLukS : 50 μg; single timepoint
10991843|NCT01011335|FG011|Participant Flow|Alum Placebo|Intramuscular; Alum placebo : 10, 25, 50, 100 μg; single timepoint
10991844|NCT01011335|FG012|Participant Flow|Normal Saline Placebo|Intramuscular; Saline Placebo : 10, 25, 50, 100 μg; single timepoint
10991845|NCT01011335|OG000|Outcome|Monovalent rAT Doses|Monovalent rAT 10µg, 25µg, 50µg, 100µg
10991846|NCT01011335|OG001|Outcome|Monovalent rLukS Doses|Monovalent rLukS 10µg, 25µg, 50µg, 100µg
10991847|NCT01011335|OG002|Outcome|Bivalent rAT/rLukS Doses|rAT/rLukS 10µg, 25µg, 50µg
10991848|NCT01011335|OG003|Outcome|Placebo Doses|Alum placebo and Saline placebo
10991849|NCT01011335|OG000|Outcome|rAT 10 µg|
10991850|NCT01011335|OG001|Outcome|rAT 25 µg|
10991851|NCT01011335|OG002|Outcome|rAT 50 µg|
10991852|NCT01011335|OG003|Outcome|rAT 100 µg|
10991853|NCT01011335|OG004|Outcome|rAT/rLukS 10 µg (for rAT)|
10991854|NCT01011335|OG005|Outcome|rAT/rLukS 25 µg (for rAT)|
10991855|NCT01011335|OG006|Outcome|rAT/rLukS 50 µg (for rAT)|
10991856|NCT01011335|OG007|Outcome|Alum Placebo (for rAT)|
10991857|NCT01011335|OG008|Outcome|Saline Placebo (for rAT)|
10991858|NCT01011335|OG009|Outcome|rLukS 10 µg|
10991859|NCT01011335|OG010|Outcome|rLukS 25 µg|
10991860|NCT01011335|OG011|Outcome|rLukS 50 µg|
10991861|NCT01011335|OG012|Outcome|rLukS 100 µg|
10991862|NCT01011335|OG013|Outcome|rAT/rLukS 10 µg (for rLukS)|
10991863|NCT01011335|OG014|Outcome|rAT/rLukS 25 µg (for rLukS)|
10991864|NCT01011335|OG015|Outcome|rAT/rLukS 50 µg (for rLukS)|
10991865|NCT01011335|OG016|Outcome|Alum Placebo (for rLukS)|
10991866|NCT01011335|OG017|Outcome|Normal Saline Placebo (for rLukS)|
10991867|NCT01011335|EG000|Reported Event|Monovalent rAT 10µg Dose|
10991868|NCT01011335|EG001|Reported Event|Monovalent rAT 25µg Dose|
10991869|NCT01011335|EG002|Reported Event|Monovalent rAT 50µg Dose|
10991870|NCT01011335|EG003|Reported Event|Monovalent rAT 100µg Dose|
10991871|NCT01011335|EG004|Reported Event|Monovalent rLukS 10µg Dose|
10991872|NCT01011335|EG005|Reported Event|Monovalent rLukS 25µg Dose|
10991873|NCT01011335|EG006|Reported Event|Monovalent rLukS 50µg Dose|
10991874|NCT01011335|EG007|Reported Event|Monovalent rLukS 100µg Dose|
10991875|NCT01011335|EG008|Reported Event|Bivalent rAT/rLukS 10µg Dose|
10991876|NCT01011335|EG009|Reported Event|Bivalent rAT/rLukS 25µg Dose|
10991877|NCT01011335|EG010|Reported Event|Bivalent rAT/rLukS 50µg Dose|
10991878|NCT01011335|EG011|Reported Event|Alum Placebo|
10991879|NCT01011335|EG012|Reported Event|Normal Saline Placebo|
10991880|NCT01011387|BG000|Baseline|NPWT System|Negative Pressure Wound Therapy
10991881|NCT01011387|FG000|Participant Flow|Negative Pressure Wound Therapy System|The Avance NPWT system is intended to help promote wound healing, including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressure. Avance NPWT system is designed to be used for a wide range of wounds which are suitable for NPWT.
10991882|NCT01011387|OG000|Outcome|NPWT System|Negative Pressure Wound Therapy
10991883|NCT01011387|EG000|Reported Event|NPWT System|Negative Pressure Wound Therapy
10991884|NCT01011413|BG000|Baseline|600mg Efavirenz|"Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)~Efavirenz: 3 x EFV 200mg tablets once daily"
10991885|NCT01011413|BG001|Baseline|400mg Efavirenz|"Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).~Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily"
10991886|NCT01011413|BG002|Baseline|Total|Total of all reporting groups
10991887|NCT01011413|FG000|Participant Flow|600mg Efavirenz|"Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)~Efavirenz: 3 x EFV 200mg tablets once daily"
10991888|NCT01011413|FG001|Participant Flow|400mg Efavirenz|"Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).~Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily"
10991889|NCT01011413|OG000|Outcome|600mg Efavirenz|Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg
10991890|NCT01011413|OG001|Outcome|400mg Efavirenz|Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
10991891|NCT01011413|OG000|Outcome|600 mg Efavirenz|EFV 600 mg plus tenofovir 300 mg and emtricitabine 200 mg daily
10991892|NCT01011413|OG001|Outcome|Efavirenz 400 mg|EFV 400 mg plus tenofovir 300 mg and emtricitabine 200 mg daily
10991893|NCT01011413|OG000|Outcome|600mg Efavirenz|Efavirenz 600mg: 3 x EFV 200 mg tablets once daily plus tenofovir/emtricitabine 300 mg /200 mg
10991894|NCT01011413|OG001|Outcome|400mg Efavirenz|Efavirenz 400 MG: 2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
10991895|NCT01011413|OG000|Outcome|600mg Efavirenz|Efavirenz 600mg: 3 x EFV 200 mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg
10991896|NCT01011413|OG001|Outcome|400mg Efavirenz|Efavirenz 400 MG: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
10991897|NCT01011413|OG000|Outcome|600mg Efavirenz|Efavirenz 600mg: 3 x EFV 200mg once daily plus tenofovir/emtricitabine 300 mg/200 mg tablets once daily
10991898|NCT01011413|EG000|Reported Event|600mg Efavirenz|"Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)~Efavirenz: 3 x EFV 200mg tablets once daily"
10991899|NCT01011413|EG001|Reported Event|400mg Efavirenz|"Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).~Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily"
10991900|NCT01011439|BG000|Baseline|Milciclib Maleate (PHA-848125AC)|"100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
10991901|NCT01011439|FG000|Participant Flow|Milciclib Maleate (PHA-848125AC)|"100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
10991902|NCT01011439|OG000|Outcome|Milciclib Maleate (PHA-848125AC)|"100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
10991903|NCT01011439|OG000|Outcome|Milciclib Maleate (PHA-848125AC)|"100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
10991904|NCT01011439|EG000|Reported Event|Milciclib Maleate (PHA-848125AC)|"100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
10991905|NCT01011465|BG000|Baseline|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991906|NCT01011465|BG001|Baseline|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991907|NCT01011465|BG002|Baseline|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991908|NCT01011465|BG003|Baseline|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991909|NCT01011465|BG004|Baseline|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991910|NCT01011465|BG005|Baseline|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991911|NCT01011465|BG006|Baseline|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
11007405|NCT01090492|FG001|Participant Flow|PRP Cohort: PF-00489791 4mg First, Then Placebo|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
10991912|NCT01011465|BG007|Baseline|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991913|NCT01011465|BG008|Baseline|Total|Total of all reporting groups
10991914|NCT01011465|FG000|Participant Flow|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991915|NCT01011465|FG001|Participant Flow|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991916|NCT01011465|FG002|Participant Flow|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991917|NCT01011465|FG003|Participant Flow|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991918|NCT01011465|FG004|Participant Flow|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991919|NCT01011465|FG005|Participant Flow|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991920|NCT01011465|FG006|Participant Flow|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991921|NCT01011465|FG007|Participant Flow|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991922|NCT01011465|OG000|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
10991923|NCT01011465|OG001|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
10991924|NCT01011465|OG002|Outcome|Female|Effects of stress exposure examined among women versus men
10991925|NCT01011465|OG003|Outcome|Male|Effects of stress exposure examined among men versus women
10991926|NCT01011465|OG004|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
10991927|NCT01011465|OG005|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
10991928|NCT01011465|EG000|Reported Event|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991929|NCT01011465|EG001|Reported Event|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991930|NCT01011465|EG002|Reported Event|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991931|NCT01011465|EG003|Reported Event|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991932|NCT01011465|EG004|Reported Event|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991933|NCT01011465|EG005|Reported Event|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
11223236|NCT02352298|EG000|Reported Event|Dario Blood Glucose Monitoring System|"Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System~Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS"
11223237|NCT02352298|EG001|Reported Event|YSI STAT|"Blood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System~YSI Analyzer: Fingerstick to obtain blood sample for analysis with YSI"
11223238|NCT02352363|BG000|Baseline|CVT-301|"Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.~CVT-301"
10991934|NCT01011465|EG006|Reported Event|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
10991935|NCT01011465|EG007|Reported Event|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
10991936|NCT01011556|BG000|Baseline|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
10991937|NCT01011556|BG001|Baseline|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991938|NCT01011556|BG002|Baseline|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991939|NCT01011556|BG003|Baseline|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991940|NCT01011556|BG004|Baseline|Total|Total of all reporting groups
10991941|NCT01011556|FG000|Participant Flow|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
10991942|NCT01011556|FG001|Participant Flow|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991943|NCT01011556|FG002|Participant Flow|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991944|NCT01011556|FG003|Participant Flow|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991945|NCT01011556|OG000|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
10991946|NCT01011556|OG001|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991947|NCT01011556|OG002|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991948|NCT01011556|OG003|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991949|NCT01011556|OG000|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
10991950|NCT01011556|OG001|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level
10991951|NCT01011556|OG000|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 mcg teriparatide subcutaneously once daily in an unblinded manner.
10991952|NCT01011556|EG000|Reported Event|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
10991953|NCT01011556|EG001|Reported Event|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991954|NCT01011556|EG002|Reported Event|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991955|NCT01011556|EG003|Reported Event|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
10991956|NCT01011673|BG000|Baseline|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
10991957|NCT01011673|BG001|Baseline|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
10991958|NCT01011673|BG002|Baseline|Total|Total of all reporting groups
10991959|NCT01011673|FG000|Participant Flow|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
10991960|NCT01011673|FG001|Participant Flow|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
10991961|NCT01011673|OG000|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
10991962|NCT01011673|OG001|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
10991963|NCT01011673|EG000|Reported Event|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
10991964|NCT01011673|EG001|Reported Event|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
10991965|NCT01011738|BG000|Baseline|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
11007406|NCT01090492|FG002|Participant Flow|PRP Cohort: Placebo First, Then PF-00489791 20 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
10991966|NCT01011738|BG001|Baseline|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
10991967|NCT01011738|BG002|Baseline|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
10991968|NCT01011738|BG003|Baseline|Total|Total of all reporting groups
10991969|NCT01011738|FG000|Participant Flow|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
10991970|NCT01011738|FG001|Participant Flow|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
10991971|NCT01011738|FG002|Participant Flow|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
10991972|NCT01011738|OG000|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
10991973|NCT01011738|OG001|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
10991974|NCT01011738|OG000|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
10991975|NCT01011738|OG002|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
10991976|NCT01011738|EG000|Reported Event|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
10991977|NCT01011738|EG001|Reported Event|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
10991978|NCT01011738|EG002|Reported Event|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
10991979|NCT01011816|BG000|Baseline|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
10991980|NCT01011816|BG001|Baseline|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
10991981|NCT01011816|BG002|Baseline|Total|Total of all reporting groups
10991982|NCT01011816|FG000|Participant Flow|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
10991983|NCT01011816|FG001|Participant Flow|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
10991984|NCT01011816|OG000|Outcome|BIOSTAT BIOLOGX|"One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc~BIOSTAT BIOLOGX: One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device"
10991985|NCT01011816|OG001|Outcome|Saline|"One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc~Saline: One injection of up to 4 mL of saline using the Biostat Delivery Device"
10991986|NCT01011816|OG000|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
10991987|NCT01011816|OG001|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
10991988|NCT01011816|EG000|Reported Event|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
10991989|NCT01011816|EG001|Reported Event|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
10991990|NCT01011829|BG000|Baseline|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
10991991|NCT01011829|BG001|Baseline|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
10991992|NCT01011829|BG002|Baseline|Total|Total of all reporting groups
10991993|NCT01011829|FG000|Participant Flow|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
10991994|NCT01011829|FG001|Participant Flow|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
10991995|NCT01011829|OG000|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
10991996|NCT01011829|OG001|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
10991997|NCT01011829|EG000|Reported Event|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
10991998|NCT01011829|EG001|Reported Event|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
10991999|NCT01011868|BG000|Baseline|Placebo|Oral Placebo
10992000|NCT01011868|BG001|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
10992001|NCT01011868|BG002|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
10992002|NCT01011868|BG003|Baseline|Total|Total of all reporting groups
10992003|NCT01011868|FG000|Participant Flow|Placebo|Oral Placebo
10992004|NCT01011868|FG001|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
10992005|NCT01011868|FG002|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
10992006|NCT01011868|OG000|Outcome|Placebo|Oral Placebo
10992007|NCT01011868|OG001|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
10992008|NCT01011868|OG002|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
10992009|NCT01011868|EG000|Reported Event|Placebo|Oral Placebo
10992010|NCT01011868|EG001|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
10992011|NCT01011868|EG002|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
10992012|NCT01011894|BG000|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
10992013|NCT01011894|FG000|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
10992014|NCT01011894|OG000|Outcome|Participants Receiving Lenalidomide|Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.
10992015|NCT01011894|EG000|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
10992016|NCT01011907|BG000|Baseline|Placebo|
10992017|NCT01011907|BG001|Baseline|Varenicline|
10992018|NCT01011907|BG002|Baseline|Total|Total of all reporting groups
10992019|NCT01011907|FG000|Participant Flow|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
10992020|NCT01011907|FG001|Participant Flow|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
10992021|NCT01011907|OG000|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
10992022|NCT01011907|OG001|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
10992023|NCT01011907|EG000|Reported Event|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
10992024|NCT01011907|EG001|Reported Event|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
10992025|NCT01011933|BG000|Baseline|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
10992026|NCT01011933|FG000|Participant Flow|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
10992027|NCT01011933|OG000|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
10992028|NCT01011933|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10992029|NCT01011933|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10992030|NCT01011933|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10992031|NCT01011933|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10992032|NCT01011933|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10992033|NCT01011933|OG005|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10992034|NCT01011933|EG000|Reported Event|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
10992035|NCT01011946|BG000|Baseline|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
10992036|NCT01011946|FG000|Participant Flow|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
10992037|NCT01011946|OG000|Outcome|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
10992038|NCT01011946|EG000|Reported Event|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
10992039|NCT01012037|BG000|Baseline|Placebo|Patients treated with matching placebo
10992040|NCT01012037|BG001|Baseline|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
10992041|NCT01012037|BG002|Baseline|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
10992042|NCT01012037|BG003|Baseline|Total|Total of all reporting groups
10992043|NCT01012037|FG000|Participant Flow|Placebo|Patients treated with matching placebo
10992044|NCT01012037|FG001|Participant Flow|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
10992045|NCT01012037|FG002|Participant Flow|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
10992046|NCT01012037|OG000|Outcome|Placebo|Patients treated with matching placebo
10992047|NCT01012037|OG001|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
10992048|NCT01012037|OG002|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
10992049|NCT01012037|EG000|Reported Event|Placebo|Patients treated with matching placebo
10992050|NCT01012037|EG001|Reported Event|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
10992051|NCT01012037|EG002|Reported Event|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
10992052|NCT01012089|BG000|Baseline|Daptomycin Hemodialysis|Daptomycin: Daptomycin IV 5 mg/kg one time dose to patient receiving intermittent hemodialysis on MWF
10992053|NCT01012089|BG001|Baseline|Daptomycin Peritoneal Dialysis|Daptomycin: Daptomycin IV 5 mg/kg one time dose to patient receiving continuous cycling peritoneal dialysis
10992054|NCT01012089|BG002|Baseline|Total|Total of all reporting groups
10992055|NCT01012089|FG000|Participant Flow|Daptomycin|Daptomycin: Daptomycin IV 5 mg/kg one time dose
10992056|NCT01012089|OG000|Outcome|Daptomycin Hemodialysis|Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
10992057|NCT01012089|OG001|Outcome|Daptomycin Peritoneal Dialysis|Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
10992058|NCT01012089|EG000|Reported Event|Daptomycin Peritoneal Dialysis|Pediatric dialysis patients who received a one time dose of Daptomycin: Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
10992059|NCT01012089|EG001|Reported Event|Daptomycin Hemodialysis|Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
10992060|NCT01012219|BG000|Baseline|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
10992061|NCT01012219|FG000|Participant Flow|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
10992062|NCT01012219|OG000|Outcome|Clopidogrel + Aspirin +Laropiprant|Participants from Periods 1 and 2
10992063|NCT01012219|OG001|Outcome|Clopidogrel + Aspirin|Participants from Periods 1 and 2
10992064|NCT01012219|EG000|Reported Event|Laropiprant + Clopidrogel + Aspirin|Participants from Periods 1 and 2
10992065|NCT01012219|EG001|Reported Event|Clopidogrel + Aspirin|Participants from Periods 1 and 2
10992066|NCT01012219|EG002|Reported Event|Laropiprant + Niacin|Participants from Period 3
10992067|NCT01012245|BG000|Baseline|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
10992068|NCT01012245|BG001|Baseline|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit
10992069|NCT01012245|BG002|Baseline|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
10992070|NCT01012245|BG003|Baseline|Other Medication|Subjects with other or no hypotensive therapy at baseline visit
10992071|NCT01012245|BG004|Baseline|Total|Total of all reporting groups
10992072|NCT01012245|FG000|Participant Flow|Subjects With Glaucoma and Ocular Hypertension|All subjects group: documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups: Xalatan®: subjects with Xalatan® (latanoprost) monotherapy at baseline visit; Betablockers: subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit; Xalacom®: subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit; other medications: subjects with other or no hypotensive therapy at baseline visit.
10992073|NCT01012245|OG000|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
10992074|NCT01012245|OG001|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
10992075|NCT01012245|OG002|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
10992076|NCT01012245|OG003|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
10992077|NCT01012245|OG004|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
10992078|NCT01012245|OG000|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
10992079|NCT01012245|OG000|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
10992080|NCT01012245|OG001|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
10992081|NCT01012245|EG000|Reported Event|All Subjects|Subjects with documented diagnosis of glaucoma or ocular hypertension at baseline visit.
10992082|NCT01012258|BG000|Baseline|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
10992083|NCT01012258|FG000|Participant Flow|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
11348217|NCT04195893|FG000|Participant Flow|Somofilcon A Then Etafilcon A|"Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.~somofilcon A: Contact Lens etafilcon A: Contact Lens"
10992084|NCT01012258|OG000|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
10992085|NCT01012258|EG000|Reported Event|Cetuximab: Treatment Emergent Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Treatment emergent phase, i.e. treatment-emergent adverse events (TEAEs, adverse events which occur or worsen on the first dosing day of trial treatment and until 60 days after the last trial treatment administration (cetuximab or radiotherapy).
10992086|NCT01012258|EG001|Reported Event|Cetuximab: Late Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Late phase, i.e. adverse events which occur or worsen more than 60 days after the last trial treatment administration (cetuximab or radiotherapy), and before end of trial.
10992087|NCT01012297|BG000|Baseline|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
10992088|NCT01012297|BG001|Baseline|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
10992089|NCT01012297|BG002|Baseline|Total|Total of all reporting groups
10992090|NCT01012297|FG000|Participant Flow|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
10992091|NCT01012297|FG001|Participant Flow|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
10992092|NCT01012297|OG000|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
10992093|NCT01012297|OG001|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
10992094|NCT01012297|EG000|Reported Event|Arm I|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
10992095|NCT01012297|EG001|Reported Event|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
10992096|NCT01012323|BG000|Baseline|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
10992097|NCT01012323|FG000|Participant Flow|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
10992098|NCT01012323|OG000|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
10992099|NCT01012323|EG000|Reported Event|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
10992100|NCT01012336|BG000|Baseline|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
10992101|NCT01012336|FG000|Participant Flow|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
10992102|NCT01012336|OG000|Outcome|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
10992103|NCT01012336|EG000|Reported Event|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
10992104|NCT01012362|BG000|Baseline|Arm 1: Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
10992105|NCT01012362|BG001|Baseline|Arm 1: Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
10992106|NCT01012362|BG002|Baseline|Arm 1: Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
10992107|NCT01012362|BG003|Baseline|Arm 1: Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
10992108|NCT01012362|BG004|Baseline|Arm 2|Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
10992109|NCT01012362|BG005|Baseline|Total|Total of all reporting groups
10992110|NCT01012362|FG000|Participant Flow|Arm 1: Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
10992111|NCT01012362|FG001|Participant Flow|Arm 1: Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
10992112|NCT01012362|FG002|Participant Flow|Arm 1: Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
10992113|NCT01012362|FG003|Participant Flow|Arm 1: Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
10992114|NCT01012362|FG004|Participant Flow|Arm 2|Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
10992115|NCT01012362|OG000|Outcome|All Arm 1 Participants|All participants who received at least one cycle of one of the following 4 dose levels: Dose Level 1: Pazopanib 400mg - Ixabepilone 32mg/m2; Dose Level 2: Pazopanib 400mg - Ixabepilone 40mg/m2; Dose Level 3: Pazopanib 600mg - Ixabepilone 32 mg/m2; or Dose Level 4: Pazopanib 800mg - Ixabepilone 32 mg//m2.
10992116|NCT01012362|OG000|Outcome|Arm 1: Dose Level 1|400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.
10992117|NCT01012362|OG001|Outcome|Arm 1: Dose Level 2|400 milligrams (mg) of Pazopanib and Ixabepilone 40 mg/m2
10992118|NCT01012362|OG002|Outcome|Arm 1: Dose Level 3|600 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
10992119|NCT01012362|OG003|Outcome|Arm 1: Dose Level 4|800 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
10992120|NCT01012362|OG004|Outcome|Arm 2: Dose Level 3|6400 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
10992121|NCT01012362|OG000|Outcome|Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
10992122|NCT01012362|OG001|Outcome|Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
10992123|NCT01012362|OG002|Outcome|Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
10992124|NCT01012362|OG003|Outcome|Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
10992125|NCT01012362|EG000|Reported Event|Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
10992126|NCT01012362|EG001|Reported Event|Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
10992127|NCT01012362|EG002|Reported Event|Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2 Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.
10992128|NCT01012362|EG003|Reported Event|Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
10992129|NCT01012388|BG000|Baseline|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
10992130|NCT01012388|FG000|Participant Flow|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
10992131|NCT01012388|OG000|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
10992132|NCT01012388|EG000|Reported Event|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
10992133|NCT01012440|BG000|Baseline|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
10992134|NCT01012440|FG000|Participant Flow|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
10992135|NCT01012440|OG000|Outcome|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
10992136|NCT01012440|EG000|Reported Event|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
10992137|NCT01012492|BG000|Baseline|Abatacept|"Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.~Abatacept: Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept."
10992138|NCT01012492|FG000|Participant Flow|Abatacept|"Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.~Abatacept: Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept."
10992139|NCT01012492|OG000|Outcome|Abatacept|"Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.~Abatacept: Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept."
10992140|NCT01012492|EG000|Reported Event|Abatacept|"In this trial, we will test the safety and tolerability of the addition of the CD28-B7 blockade agent, abatacept, as an adjunctive therapy for the prevention of GvHD in a high-risk BMT cohort. Four doses of abatacept will be given according to a dosing schedule based on previous trials using CD28-B7 blockade with belatacept in kidney transplantation. Pharmacokinetic and pharmakodynamic analysis of abatacept will be undertaken, as well as an evaluation of the incidence and severity of acute GvHD in this patient cohort.~Dosage: Abatacept is administered as an intravenous infusion under medically controlled conditions. Dose is 10mg/kg with a maximum dose of 1 gram. Abatacept should be administered as a 30-minute intravenous infusion. In this study, abatacept will be dosed on days -1, +5, +14, +28 post-transplant. Small adjustments in dose to accommodate abatacept vial size may be acceptable. These dose adjustments must be approved by the study PI."
10992141|NCT01012622|BG000|Baseline|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
10992142|NCT01012622|FG000|Participant Flow|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
10992143|NCT01012622|OG000|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
10992144|NCT01012622|EG000|Reported Event|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
10992145|NCT01012661|BG000|Baseline|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
10992146|NCT01012661|FG000|Participant Flow|Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl). The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).
10992147|NCT01012661|OG000|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
10992148|NCT01012661|OG001|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
10992149|NCT01012661|EG000|Reported Event|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
10992150|NCT01012661|EG001|Reported Event|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
10992151|NCT01012674|BG000|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
10992152|NCT01012674|FG000|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
10992153|NCT01012674|OG000|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
10992154|NCT01012674|OG001|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
10992155|NCT01012674|EG000|Reported Event|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
10992156|NCT01012674|EG001|Reported Event|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
10992157|NCT01012674|EG002|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from CT angiography after the IV administration of an iodinated contrast medium
10992158|NCT01012674|EG003|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn from the study before Dotarem IV administration whatever the reason
10992159|NCT01012713|BG000|Baseline|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
10992160|NCT01012713|FG000|Participant Flow|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in the Psoriasis Area and Severity Index thereafter."
10992161|NCT01012713|OG000|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
10992162|NCT01012713|OG000|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than a 75% reduction in Psoriasis Area and Severity Index."
10992163|NCT01012713|EG000|Reported Event|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
10992164|NCT01012739|BG000|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg via the Concept1 dry-powder inhaler (DPI), indacaterol 60 µg via the Simoon DPI, indacaterol 120 µg via the Simoon DPI, and placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992165|NCT01012739|FG000|Participant Flow|Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg|In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
11223239|NCT02352363|BG001|Baseline|Observational Cohort|"Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.~Observational cohort"
11223240|NCT02352363|BG002|Baseline|Total|Total of all reporting groups
10992166|NCT01012739|FG001|Participant Flow|Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo|In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992167|NCT01012739|FG002|Participant Flow|Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg|In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992168|NCT01012739|FG003|Participant Flow|Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg|In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992169|NCT01012739|OG000|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992170|NCT01012739|OG001|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992171|NCT01012739|OG002|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992172|NCT01012739|OG003|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992173|NCT01012739|OG000|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992174|NCT01012739|EG000|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI)only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992175|NCT01012739|EG001|Reported Event|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992176|NCT01012739|EG002|Reported Event|Indacaterol 120 μg|Patients received indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
11223241|NCT02352363|FG000|Participant Flow|CVT-301|"Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.~CVT-301"
10846479|NCT00276406|FG000|Participant Flow|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
11348218|NCT04195893|FG001|Participant Flow|Etafilcon A Then Somofilcon A|"Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.~etafilcon A: Contact Lens somofilcon A: Contact Lens"
10992177|NCT01012739|EG003|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
10992178|NCT01012765|BG000|Baseline|Safety Set|The safety set included all participants who received at least one dose of study medication during at least one study period.
10992179|NCT01012765|FG000|Participant Flow|Tiotropium - Placebo - Indacaterol|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992180|NCT01012765|FG001|Participant Flow|Indacaterol - Placebo - Tiotropium|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992181|NCT01012765|FG002|Participant Flow|Indacaterol - Tiotropium - Placebo|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992182|NCT01012765|FG003|Participant Flow|Placebo - Indacaterol - Tiotropium|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992183|NCT01012765|FG004|Participant Flow|Placebo - Tiotropium - Indacaterol|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992184|NCT01012765|FG005|Participant Flow|Tiotropium - Indacaterol - Placebo|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992185|NCT01012765|OG000|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992186|NCT01012765|OG001|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992187|NCT01012765|OG002|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992188|NCT01012765|EG000|Reported Event|Indacaterol 150ug|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992189|NCT01012765|EG001|Reported Event|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
10992190|NCT01012765|EG002|Reported Event|Tiotropium 18ug|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
11348219|NCT04195893|OG000|Outcome|Somofilcon A|"Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.~somofilcon A: Contact Lens"
10876289|NCT00441545|EG000|Reported Event|Fosrenol|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
10876290|NCT00441545|EG001|Reported Event|Sevelamer HCl|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
10876291|NCT00441558|BG000|Baseline|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
10876292|NCT00441558|FG000|Participant Flow|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
10876293|NCT00441558|OG000|Outcome|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
10876294|NCT00441558|EG000|Reported Event|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
10876295|NCT00441584|BG000|Baseline|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
10876296|NCT00441584|FG000|Participant Flow|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
10876297|NCT00441584|OG000|Outcome|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
10876298|NCT00441584|EG000|Reported Event|PegIntron Plus REBETOL|
10876299|NCT00441701|BG000|Baseline|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
10876300|NCT00441701|BG001|Baseline|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876301|NCT00441701|BG002|Baseline|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
10876302|NCT00441701|BG003|Baseline|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876303|NCT00441701|BG004|Baseline|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
10876304|NCT00441701|BG005|Baseline|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876305|NCT00441701|BG006|Baseline|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
10876306|NCT00441701|BG007|Baseline|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
10876307|NCT00441701|BG008|Baseline|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
10876308|NCT00441701|BG009|Baseline|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876309|NCT00441701|BG010|Baseline|Total|Total of all reporting groups
10876310|NCT00441701|FG000|Participant Flow|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks
10876311|NCT00441701|FG001|Participant Flow|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876312|NCT00441701|FG002|Participant Flow|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
10876313|NCT00441701|FG003|Participant Flow|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876314|NCT00441701|FG004|Participant Flow|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
10876315|NCT00441701|FG005|Participant Flow|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876316|NCT00441701|FG006|Participant Flow|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
10876317|NCT00441701|FG007|Participant Flow|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
10876318|NCT00441701|FG008|Participant Flow|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
10876319|NCT00441701|FG009|Participant Flow|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876320|NCT00441701|OG000|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
10876321|NCT00441701|OG001|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
10876322|NCT00441701|OG002|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
10876323|NCT00441701|OG003|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876324|NCT00441701|OG000|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
10876325|NCT00441701|OG001|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
10876326|NCT00441701|OG002|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
10876327|NCT00441701|OG003|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876328|NCT00441701|EG000|Reported Event|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
10992191|NCT01012921|BG000|Baseline|Bio-Gide® Membrane|"Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~Bio-Gide® membrane: Device application at surgery"
10992192|NCT01012921|BG001|Baseline|MembraGel|"MembraGel The Straumann membrane is a synthetic degradable barrier membrane~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~MembraGel: Device application at surgery"
10992193|NCT01012921|BG002|Baseline|Total|Total of all reporting groups
10992194|NCT01012921|FG000|Participant Flow|Bio-Gide® Membrane|"Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~Bio-Gide® membrane: Device application at surgery"
10992195|NCT01012921|FG001|Participant Flow|MembraGel|"MembraGel The Straumann membrane is a synthetic degradable barrier membrane~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~MembraGel: Device application at surgery"
10992196|NCT01012921|OG000|Outcome|Bio-Gide® Membrane|"Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~Bio-Gide® membrane: Device application at surgery"
10992197|NCT01012921|OG001|Outcome|MembraGel|"MembraGel The Straumann membrane is a synthetic degradable barrier membrane~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~MembraGel: Device application at surgery"
10992198|NCT01012921|EG000|Reported Event|Bio-Gide® Membrane|"Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~Bio-Gide® membrane: Device application at surgery"
10992199|NCT01012921|EG001|Reported Event|MembraGel|"MembraGel The Straumann membrane is a synthetic degradable barrier membrane~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~MembraGel: Device application at surgery"
10992200|NCT01012947|BG000|Baseline|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
10992201|NCT01012947|BG001|Baseline|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
10992202|NCT01012947|BG002|Baseline|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
10992203|NCT01012947|BG003|Baseline|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator-initiated visit counseling bimonthly.
10992204|NCT01012947|BG004|Baseline|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
10992205|NCT01012947|BG005|Baseline|Total|Total of all reporting groups
10992206|NCT01012947|FG000|Participant Flow|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
10992207|NCT01012947|FG001|Participant Flow|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
10992208|NCT01012947|FG002|Participant Flow|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
10992209|NCT01012947|FG003|Participant Flow|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator-initiated visit counseling bimonthly.
10992210|NCT01012947|FG004|Participant Flow|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
10992211|NCT01012947|OG000|Outcome|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
10846480|NCT00276406|FG001|Participant Flow|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
10992212|NCT01012947|OG001|Outcome|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
10992213|NCT01012947|OG002|Outcome|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
10992214|NCT01012947|OG003|Outcome|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator-initiated visit counseling bimonthly.
10992215|NCT01012947|OG004|Outcome|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
10992216|NCT01012947|EG000|Reported Event|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
10992217|NCT01012947|EG001|Reported Event|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
10992218|NCT01012947|EG002|Reported Event|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
10992219|NCT01012947|EG003|Reported Event|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator-initiated visit counseling bimonthly.
10992220|NCT01012947|EG004|Reported Event|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
10992221|NCT01012973|BG000|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
10992222|NCT01012973|BG001|Baseline|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
10992223|NCT01012973|BG002|Baseline|Total|Total of all reporting groups
10992224|NCT01012973|FG000|Participant Flow|Aflibercept Injection First, Then Aflibercept Injection|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
10992225|NCT01012973|FG001|Participant Flow|Sham Treatment First, Then Aflibercept Injection|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
10992226|NCT01012973|OG000|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
10992227|NCT01012973|OG001|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
10992228|NCT01012973|EG000|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
10992229|NCT01012973|EG001|Reported Event|Sham Treatment (Until Week 20)|Participants received sham treatment administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
10992230|NCT01012973|EG002|Reported Event|Aflibercept Injection (Until Week 48)|Participants who continued the study drug until Week 24 received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
10992231|NCT01012973|EG003|Reported Event|Sham Treatment (Until Week 48)|Participants who continued the study drug until Week 24 received sham treatment administered every 4 weeks from Week 24 to Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
10992232|NCT01012973|EG004|Reported Event|Aflibercept Injection Continued (Until Week 68)|Participants on IAI who continued the study drug until Week 52, received 2 mg dose of IAI depending on the study retreatment criteria at Week 52, 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
10992233|NCT01012973|EG005|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 68)|Participants on sham treatment switched to IAI, received a 2 mg dose of IAI at Week 52 and depending on the study retreatment criteria at Week 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
10992234|NCT01012999|BG000|Baseline|Intranasal Sufentanil, Pain Relief|"Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.~Intranasal administration, 0.5 mcg/kg to an extremity and in moderate to severe pain, one time dose."
10992235|NCT01012999|FG000|Participant Flow|Intranasal Sufentanil, Pain Relief|"Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.~Intranasal administration, 0.5 mcg/kg, one time dose."
10992236|NCT01012999|OG000|Outcome|Intranasal Sufentanil, Pain Relief|Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
10992237|NCT01012999|EG000|Reported Event|Intranasal Sufentanil, Pain Relief|Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
10992238|NCT01013194|BG000|Baseline|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells.
10992239|NCT01013194|BG001|Baseline|Control Patients|Patients with end-stage chronic liver disease on standard therapy in waiting list for liver transplantation.
10992240|NCT01013194|BG002|Baseline|Total|Total of all reporting groups
10992241|NCT01013194|FG000|Participant Flow|Treated Patients|"Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.~Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance.~Cell infusion: between 5x10^8 and 10x10^8 cells. Number of sessions: up to 2."
10992242|NCT01013194|FG001|Participant Flow|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
10992243|NCT01013194|OG000|Outcome|Treated Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
10992244|NCT01013194|OG001|Outcome|Control Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
10992245|NCT01013194|OG000|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells
10992246|NCT01013194|OG001|Outcome|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
10992247|NCT01013194|OG000|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells.
10992248|NCT01013194|OG001|Outcome|Control Patients|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
10992249|NCT01013194|EG000|Reported Event|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
10992250|NCT01013194|EG001|Reported Event|Control Group|Patients with end-stage chronic liver disease in waiting list for liver transplantation.
10992251|NCT01013207|BG000|Baseline|All Participants|
10992252|NCT01013207|FG000|Participant Flow|All Participants|
10992253|NCT01013207|OG000|Outcome|All Participants|
10992254|NCT01013207|EG000|Reported Event|All Participants|
10992255|NCT01013285|BG000|Baseline|Treatment Arm|"bevacizumab~temozolomide~external beam radiation therapy"
10992256|NCT01013285|BG001|Baseline|Historical Control UCLA/Kaiser|A University of California, Los Angeles/Kaiser Permanente Los Angeles(KPLA) control cohort of newly diagnosed patients treated with first-line radiation therapy and temozolomide who had mostly received bevacizumab at recurrence was derived for comparison. Data excluded where records not complete
10992257|NCT01013285|BG002|Baseline|Total|Total of all reporting groups
10992258|NCT01013285|FG000|Participant Flow|Treatment Arm|"bevacizumab~temozolomide~external beam radiation therapy"
10992259|NCT01013285|FG001|Participant Flow|Historical Control UCLA/KPLA|A University of California, Los Angeles/Kaiser Permanente Los Angeles(KPLA) control cohort of newly diagnosed patients treated with first-line radiation therapy and temozolomide who had mostly received bevacizumab at recurrence was derived for comparison.
10992260|NCT01013285|OG000|Outcome|Treatment Arm|"bevacizumab~temozolomide~external beam radiation therapy"
10992261|NCT01013285|OG001|Outcome|Historical Control UCLA/KPLA|A University of California, Los Angeles/Kaiser Permanente Los Angeles(KPLA) control cohort of newly diagnosed patients treated with first-line radiation therapy and temozolomide who had mostly received bevacizumab at recurrence was derived for comparison.
10992262|NCT01013285|EG000|Reported Event|Bevacizumab, Temozolomide, External Beam Radiation|"bevacizumab~temozolomide~external beam radiation therapy"
10992263|NCT01013350|BG000|Baseline|Never Exposed to Cladribine|All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).
10992264|NCT01013350|BG001|Baseline|Exposed to Cladribine|All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).
10992265|NCT01013350|BG002|Baseline|Total|Total of all reporting groups
10992266|NCT01013350|FG000|Participant Flow|Never Exposed to Cladribine|All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826 , NCT00641537, NCT00938366 and NCT00725985).
10992267|NCT01013350|FG001|Participant Flow|Exposed to Cladribine|All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537, NCT00938366 and NCT00725985).
10992268|NCT01013350|OG000|Outcome|Never Exposed to Cladribine|All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).
10992269|NCT01013350|OG001|Outcome|Exposed to Cladribine|All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).
10992270|NCT01013350|OG000|Outcome|Exposed to Cladribine|All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).
10992271|NCT01013350|EG000|Reported Event|Never Exposed to Cladribine|All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).
10992272|NCT01013350|EG001|Reported Event|Exposed to Cladribine|All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).
10992273|NCT01013597|BG000|Baseline|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
10992274|NCT01013597|FG000|Participant Flow|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
10992275|NCT01013597|OG000|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
10992276|NCT01013597|EG000|Reported Event|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
10992277|NCT01013740|BG000|Baseline|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
10992278|NCT01013740|BG001|Baseline|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
10992279|NCT01013740|BG002|Baseline|Total|Total of all reporting groups
11348220|NCT04195893|OG001|Outcome|Etafilcon A|"Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.~etafilcon A: Contact Lens"
10876329|NCT00441701|EG001|Reported Event|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
10876330|NCT00441701|EG002|Reported Event|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
10876331|NCT00441701|EG003|Reported Event|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876332|NCT00441701|EG004|Reported Event|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
10876333|NCT00441701|EG005|Reported Event|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
10876334|NCT00441701|EG006|Reported Event|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
10876335|NCT00441701|EG007|Reported Event|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
10876336|NCT00441727|BG000|Baseline|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
10876337|NCT00441727|BG001|Baseline|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
10876338|NCT00441727|BG002|Baseline|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
10876339|NCT00441727|BG003|Baseline|Total|Total of all reporting groups
10876340|NCT00441727|FG000|Participant Flow|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
10876341|NCT00441727|FG001|Participant Flow|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
10876342|NCT00441727|FG002|Participant Flow|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
10876343|NCT00441727|OG000|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
10876344|NCT00441727|OG001|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
10876345|NCT00441727|OG002|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
10876346|NCT00441727|OG000|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
10876347|NCT00441727|OG001|Outcome|Esomeprazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
10876348|NCT00441727|OG002|Outcome|Placbo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
10876349|NCT00441727|OG001|Outcome|Esomeproazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (acetylsalicyclic acid) (75-325 mg)
10876350|NCT00441727|OG002|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
10876351|NCT00441727|EG000|Reported Event|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
10876352|NCT00441727|EG001|Reported Event|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
10876353|NCT00441727|EG002|Reported Event|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
10876354|NCT00441766|BG000|Baseline|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
10876355|NCT00441766|BG001|Baseline|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
10876356|NCT00441766|BG002|Baseline|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
10876357|NCT00441766|BG003|Baseline|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
10876358|NCT00441766|BG004|Baseline|Total|Total of all reporting groups
10876359|NCT00441766|FG000|Participant Flow|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
10876360|NCT00441766|FG001|Participant Flow|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
10876361|NCT00441766|FG002|Participant Flow|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
10876362|NCT00441766|FG003|Participant Flow|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
10876363|NCT00441766|OG000|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
10876364|NCT00441766|OG001|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
10876365|NCT00441766|OG002|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
10876366|NCT00441766|OG003|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
10876367|NCT00441766|EG000|Reported Event|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
10876368|NCT00441766|EG001|Reported Event|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
10876369|NCT00441766|EG002|Reported Event|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
10876370|NCT00441766|EG003|Reported Event|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
10876371|NCT00441792|BG000|Baseline|Midazolam|Patients received either etomidate or midazolam.
10879562|NCT00458484|BG006|Baseline|Series 2/Dose Level 3: Stereotactic Radiosurgery|"Series II: Radiation will be delivered in 3 fractions: 20 Gy x 3 fractions total dose of 60 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879563|NCT00458484|BG007|Baseline|Total|Total of all reporting groups
10992280|NCT01013740|FG000|Participant Flow|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
10992281|NCT01013740|FG001|Participant Flow|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
10992282|NCT01013740|OG000|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
10992283|NCT01013740|OG001|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
10992284|NCT01013740|EG000|Reported Event|Randomized Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2|Randomized phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
10992285|NCT01013740|EG001|Reported Event|Randomized Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2|Randomized phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
10992286|NCT01013740|EG002|Reported Event|Crossover Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2|Crossover phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
10992287|NCT01013740|EG003|Reported Event|Crossover Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2|Crossover phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
10992288|NCT01013753|BG000|Baseline|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
10992289|NCT01013753|FG000|Participant Flow|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
10992290|NCT01013753|OG000|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
10992291|NCT01013753|OG001|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
10992292|NCT01013753|OG002|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
10992293|NCT01013753|OG003|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
10992294|NCT01013753|OG004|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
10992295|NCT01013753|OG005|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10992296|NCT01013753|EG000|Reported Event|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
10992297|NCT01013753|EG001|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
10992298|NCT01013753|EG002|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
10992299|NCT01013753|EG003|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
10992300|NCT01013753|EG004|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
10992301|NCT01013753|EG005|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10992302|NCT01013792|BG000|Baseline|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
11348221|NCT04195893|EG000|Reported Event|Somofilcon A|"Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.~somofilcon A: Contact Lens"
11348222|NCT04195893|EG001|Reported Event|Etafilcon A|"Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.~etafilcon A: Contact Lens"
10992303|NCT01013792|BG001|Baseline|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
10992304|NCT01013792|BG002|Baseline|Total|Total of all reporting groups
10992305|NCT01013792|FG000|Participant Flow|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
10992306|NCT01013792|FG001|Participant Flow|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
10992307|NCT01013792|OG000|Outcome|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
10992308|NCT01013792|OG001|Outcome|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
10992309|NCT01013792|EG000|Reported Event|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
10992310|NCT01013792|EG001|Reported Event|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
10992311|NCT01013844|BG000|Baseline|Solo Learning|Participant learning alone (without partner).
10992312|NCT01013844|BG001|Baseline|Dyadic Learning|Participant and partner learning together.
10992313|NCT01013844|BG002|Baseline|Total|Total of all reporting groups
10992314|NCT01013844|FG000|Participant Flow|Solo Learning|Participant learning alone (without partner).
10992315|NCT01013844|FG001|Participant Flow|Dyadic Learning|Participant and partner learning together.
10992316|NCT01013844|OG000|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
10992317|NCT01013844|OG001|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
10992318|NCT01013844|OG002|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
11348223|NCT04195880|BG000|Baseline|Experimental VA Community Living Centers|"Eight VA CLCs selected to receive the INTERACT intervention~Interventions to Reduce Acute Care Transfers: Experimental CLCs were trained in INTERACT QI Intervention, containing tools, strategies and educational resources designed to catch and manage acute changes in conditions early that a Veteran may be experiencing, leading to a potential reduction in preventable hospital transfers from CLCs."
10992319|NCT01013844|OG003|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
10992320|NCT01013844|OG004|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
10992321|NCT01013844|OG005|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
10992322|NCT01013844|EG000|Reported Event|Solo Learning|Participant learning alone (without partner).
10992323|NCT01013844|EG001|Reported Event|Dyadic Learning|Participant and partner learning together.
10992324|NCT01013870|BG000|Baseline|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
10992325|NCT01013870|BG001|Baseline|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
10992326|NCT01013870|BG002|Baseline|Total|Total of all reporting groups
10992327|NCT01013870|FG000|Participant Flow|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
10992328|NCT01013870|FG001|Participant Flow|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
10992329|NCT01013870|OG000|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
10992330|NCT01013870|OG001|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
10992331|NCT01013870|EG000|Reported Event|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
10992332|NCT01013870|EG001|Reported Event|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
10992333|NCT01013883|BG000|Baseline|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
10992334|NCT01013883|BG001|Baseline|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
10992335|NCT01013883|BG002|Baseline|Total|Total of all reporting groups
10992336|NCT01013883|FG000|Participant Flow|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
10992337|NCT01013883|FG001|Participant Flow|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
10992338|NCT01013883|OG000|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
10992339|NCT01013883|OG001|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
10992340|NCT01013883|EG000|Reported Event|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
11348224|NCT04195880|BG001|Baseline|Control VA Community Living Centers|Eight CLCs, matched to experiment CLCs, based on size, location to VAMC, and hospitalization rates, did not receive the intervention and continued care as usual
10876372|NCT00441792|BG001|Baseline|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the ED and in the ICU, was directed according to the treating physician.
10876373|NCT00441792|BG002|Baseline|Total|Total of all reporting groups
10876374|NCT00441792|FG000|Participant Flow|Midazolam|Patients received either etomidate or midazolam.
10876375|NCT00441792|FG001|Participant Flow|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the ED and in the ICU, was directed according to the treating physician.
10876376|NCT00441792|OG000|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
10876377|NCT00441792|OG001|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
10876378|NCT00441792|EG000|Reported Event|Midazolam|Patients received either etomidate or midazolam.
10876379|NCT00441792|EG001|Reported Event|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the ED and in the ICU, was directed according to the treating physician.
10876380|NCT00441883|BG000|Baseline|PF-03187207 0.024% AM|PF-03187207 0.024% dosed in the morning
10876381|NCT00441883|BG001|Baseline|PF-03187207 0.040% AM|PF-03187207 0.040% dosed in the morning
10876382|NCT00441883|BG002|Baseline|PF-03187207 0.040% PM|PF-03187207 0.040% dosed in the evening
10876383|NCT00441883|BG003|Baseline|Latanoprost 0.005% AM|Latanoprost 0.005% dosed in the morning
10876384|NCT00441883|BG004|Baseline|Latanoprost 0.005% PM|Latanoprost 0.005% dosed in the evening
10876385|NCT00441883|BG005|Baseline|Total|Total of all reporting groups
10876386|NCT00441883|FG000|Participant Flow|PF-03187207 0.024% AM|PF-03187207 0.024% dosed in the morning
10876387|NCT00441883|FG001|Participant Flow|PF-03187207 0.040% AM|PF-03187207 0.040% dosed in the morning
10876388|NCT00441883|FG002|Participant Flow|PF-03187207 0.040% PM|PF-03187207 0.040% dosed in the evening
10876389|NCT00441883|FG003|Participant Flow|Latanoprost 0.005% AM|Latanoprost 0.005% dosed in the morning
10876390|NCT00441883|FG004|Participant Flow|Latanoprost 0.005% PM|Latanoprost 0.005% dosed in the evening
11348225|NCT04195880|BG002|Baseline|Total|Total of all reporting groups
10876391|NCT00441883|OG000|Outcome|PF-03187207 0.024% AM|PF-03187207 0.024% dosed in the morning
10876392|NCT00441883|OG001|Outcome|PF-03187207 0.040% AM|PF-03187207 0.040% dosed in the morning
10876393|NCT00441883|OG002|Outcome|PF-03187207 0.040% PM|PF-03187207 0.040% dosed in the evening
10876394|NCT00441883|OG003|Outcome|Latanoprost 0.005% AM|Latanoprost 0.005% dosed in the morning
10876395|NCT00441883|OG004|Outcome|Latanoprost 0.005% PM|Latanoprost 0.005% dosed in the evening
10876396|NCT00441883|EG000|Reported Event|PF-03187207 0.024% AM|PF-03187207 0.024% dosed in the morning
10876397|NCT00441883|EG001|Reported Event|PF-03187207 0.040% AM|PF-03187207 0.040% dosed in the morning
10876398|NCT00441883|EG002|Reported Event|PF-03187207 0.040% PM|PF-03187207 0.040% dosed in the evening
10876399|NCT00441883|EG003|Reported Event|Latanoprost 0.005% AM|Latanoprost 0.005% dosed in the morning
10876400|NCT00441883|EG004|Reported Event|Latanoprost 0.005% PM|Latanoprost 0.005% dosed in the evening
10876401|NCT00441974|BG000|Baseline|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
10992341|NCT01013883|EG001|Reported Event|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
10992342|NCT01013961|BG000|Baseline|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
10992343|NCT01013961|BG001|Baseline|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
10992344|NCT01013961|BG002|Baseline|Total|Total of all reporting groups
10992345|NCT01013961|FG000|Participant Flow|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
10992346|NCT01013961|FG001|Participant Flow|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
10992347|NCT01013961|OG000|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
10992348|NCT01013961|OG001|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
10992349|NCT01013961|EG000|Reported Event|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
10992350|NCT01013961|EG001|Reported Event|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
10992351|NCT01014013|BG000|Baseline|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
10992352|NCT01014013|BG001|Baseline|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
10992353|NCT01014013|BG002|Baseline|Total|Total of all reporting groups
10992354|NCT01014013|FG000|Participant Flow|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
10992355|NCT01014013|FG001|Participant Flow|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
10992356|NCT01014013|OG000|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
11223242|NCT02352363|FG001|Participant Flow|Observational Cohort|"Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.~Observational cohort"
11223243|NCT02352363|OG000|Outcome|CVT-301|"Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.~CVT-301"
10992357|NCT01014013|OG001|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
10992358|NCT01014013|OG000|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
10992359|NCT01014013|OG001|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
10992360|NCT01014013|EG000|Reported Event|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
10992361|NCT01014013|EG001|Reported Event|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
10992362|NCT01014091|BG000|Baseline|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992363|NCT01014091|BG001|Baseline|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992364|NCT01014091|BG002|Baseline|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992365|NCT01014091|BG003|Baseline|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992366|NCT01014091|BG004|Baseline|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992367|NCT01014091|BG005|Baseline|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992368|NCT01014091|BG006|Baseline|Total|Total of all reporting groups
10992369|NCT01014091|FG000|Participant Flow|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992370|NCT01014091|FG001|Participant Flow|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992371|NCT01014091|FG002|Participant Flow|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992372|NCT01014091|FG003|Participant Flow|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992373|NCT01014091|FG004|Participant Flow|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992374|NCT01014091|FG005|Participant Flow|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992375|NCT01014091|OG000|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992376|NCT01014091|OG001|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992377|NCT01014091|OG002|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992378|NCT01014091|OG000|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992379|NCT01014091|OG001|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10876402|NCT00441974|FG000|Participant Flow|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
10876403|NCT00441974|OG000|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
10876404|NCT00441974|OG001|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
10876405|NCT00441974|OG002|Outcome|Total|Total of HBeAg+ and HBeAg- participants
10876406|NCT00441974|OG000|Outcome|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
10876407|NCT00441974|EG000|Reported Event|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
10876408|NCT00442013|BG000|Baseline|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
10876409|NCT00442013|BG001|Baseline|Placebo Group|Matching placebo
10876410|NCT00442013|BG002|Baseline|Total|Total of all reporting groups
10876411|NCT00442013|FG000|Participant Flow|Lansoprazole Group|15 mg/day by mouth for children weighing less than 30kg, one tablet per day in the evening before a meal 30 mg/day by mouth for children weighing 30 kg or more, two tablets per day in the evening before a meal
10876412|NCT00442013|FG001|Participant Flow|Placebo Group|Matching placebo with no active ingredients. Either 1 or 2 tablets per day, depending on weight, in the evening before a meal
10876413|NCT00442013|OG000|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
10876414|NCT00442013|OG001|Outcome|Placebo Group|matching placebo
10876415|NCT00442013|OG001|Outcome|Placebo Group|Matching placebo
10876416|NCT00442013|EG000|Reported Event|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
10876417|NCT00442013|EG001|Reported Event|Placebo Group|Matching placebo
10876418|NCT00442169|BG000|Baseline|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
10876419|NCT00442169|BG001|Baseline|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
10876420|NCT00442169|BG002|Baseline|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876421|NCT00442169|BG003|Baseline|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876422|NCT00442169|BG004|Baseline|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
10876423|NCT00442169|BG005|Baseline|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876424|NCT00442169|BG006|Baseline|Total|Total of all reporting groups
10876425|NCT00442169|FG000|Participant Flow|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
10876426|NCT00442169|FG001|Participant Flow|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
10876427|NCT00442169|FG002|Participant Flow|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876428|NCT00442169|FG003|Participant Flow|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876429|NCT00442169|FG004|Participant Flow|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
10876430|NCT00442169|FG005|Participant Flow|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876431|NCT00442169|OG000|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
10876432|NCT00442169|OG001|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
10876433|NCT00442169|OG002|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876434|NCT00442169|OG003|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876435|NCT00442169|OG004|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
10876436|NCT00442169|OG005|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876437|NCT00442169|EG000|Reported Event|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
10876438|NCT00442169|EG001|Reported Event|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
10876439|NCT00442169|EG002|Reported Event|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876440|NCT00442169|EG003|Reported Event|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876441|NCT00442169|EG004|Reported Event|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
10876442|NCT00442169|EG005|Reported Event|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
10876443|NCT00442286|BG000|Baseline|Roll-In|Subjects that were not included in endpoint analyses
10992380|NCT01014091|OG002|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992381|NCT01014091|OG003|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992382|NCT01014091|OG004|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992383|NCT01014091|OG005|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992384|NCT01014091|OG000|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992385|NCT01014091|OG001|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992386|NCT01014091|OG002|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992387|NCT01014091|OG000|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992388|NCT01014091|OG001|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992389|NCT01014091|OG002|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992390|NCT01014091|EG000|Reported Event|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992391|NCT01014091|EG001|Reported Event|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
10992392|NCT01014091|EG002|Reported Event|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992393|NCT01014091|EG003|Reported Event|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
10992394|NCT01014091|EG004|Reported Event|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992395|NCT01014091|EG005|Reported Event|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
10992396|NCT01014143|BG000|Baseline|Fluoride Toothpaste|negative control
10992397|NCT01014143|BG001|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
10992398|NCT01014143|BG002|Baseline|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
10992399|NCT01014143|BG003|Baseline|Total|Total of all reporting groups
10992400|NCT01014143|FG000|Participant Flow|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
10992401|NCT01014143|FG001|Participant Flow|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
10992402|NCT01014143|FG002|Participant Flow|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
10992403|NCT01014143|OG000|Outcome|Fluoride Toothpaste|negative control
10992404|NCT01014143|OG001|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
10992405|NCT01014143|OG002|Outcome|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
10992406|NCT01014143|EG000|Reported Event|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
10992407|NCT01014143|EG001|Reported Event|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
10992408|NCT01014143|EG002|Reported Event|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
10992409|NCT01014169|BG000|Baseline|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
10992410|NCT01014169|BG001|Baseline|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
10992411|NCT01014169|BG002|Baseline|Total|Total of all reporting groups
10992412|NCT01014169|FG000|Participant Flow|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
10992413|NCT01014169|FG001|Participant Flow|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
10992414|NCT01014169|OG000|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
10992415|NCT01014169|OG001|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
10992416|NCT01014169|EG000|Reported Event|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
10992417|NCT01014169|EG001|Reported Event|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
10992418|NCT01014208|BG000|Baseline|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
10992419|NCT01014208|BG001|Baseline|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
10992420|NCT01014208|BG002|Baseline|Total|Total of all reporting groups
10992421|NCT01014208|FG000|Participant Flow|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
10992422|NCT01014208|FG001|Participant Flow|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
10992423|NCT01014208|OG000|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
11007407|NCT01090492|FG003|Participant Flow|PRP Cohort: PF-00489791 20 mg First, Then Placebo|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
10992424|NCT01014208|OG001|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
10992425|NCT01014208|EG000|Reported Event|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
10992426|NCT01014208|EG001|Reported Event|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
10992427|NCT01014351|BG000|Baseline|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
10992428|NCT01014351|FG000|Participant Flow|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
10992429|NCT01014351|OG000|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
10992430|NCT01014351|EG000|Reported Event|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
10992431|NCT01014390|BG000|Baseline|WallFlex Biliary RX FC Stent System|"The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.~WallFlex Biliary RX Fully Covered Stent System: Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients."
10992432|NCT01014390|FG000|Participant Flow|WallFlex Biliary RX FC Stent System|"The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.~WallFlex Biliary RX Fully Covered Stent System: Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients."
10992433|NCT01014390|OG000|Outcome|WallFlex Biliary RX FC Stent System|The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
10992434|NCT01014390|EG000|Reported Event|WallFlex Biliary RX FC Stent System|evaluated for treatment of benign biliary strictures.
10992435|NCT01014403|BG000|Baseline|Enoxaparin 30 mg SQ q12 Hours|"Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury.~enoxaparin: Enoxaparin 30 mg sq q 12 hours"
10992436|NCT01014403|BG001|Baseline|Placebo|"vehicle administered sq q 12 hours~placebo: vehicle"
10992437|NCT01014403|BG002|Baseline|Total|Total of all reporting groups
10992438|NCT01014403|FG000|Participant Flow|Enoxaparin 30 mg SQ q12 Hours|"Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury.~enoxaparin: Enoxaparin 30 mg sq q 12 hours"
10992439|NCT01014403|FG001|Participant Flow|Placebo|"vehicle administered sq q 12 hours~placebo: vehicle"
10992440|NCT01014403|OG000|Outcome|Enoxaparin 30 mg SQ q12 Hours|"Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury.~enoxaparin: Enoxaparin 30 mg sq q 12 hours"
10992441|NCT01014403|OG001|Outcome|Placebo|"vehicle administered sq q 12 hours~placebo: vehicle"
10876444|NCT00442286|BG001|Baseline|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
10876445|NCT00442286|BG002|Baseline|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
10876446|NCT00442286|BG003|Baseline|Total|Total of all reporting groups
10876447|NCT00442286|FG000|Participant Flow|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
10876448|NCT00442286|FG001|Participant Flow|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
10876449|NCT00442286|OG000|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
10876450|NCT00442286|OG001|Outcome|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
10876451|NCT00442286|OG000|Outcome|All Implanted or Attempted Patients|All Implanted or Attempted patients enrolled in the study. Roll-ins were excluded.
10876452|NCT00442286|OG000|Outcome|All Implanted or Attempted Patients|All Implanted or Attempted patients active at 30 days post-implant. Excludes roll-in patients.
10876453|NCT00442286|EG000|Reported Event|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
10876454|NCT00442286|EG001|Reported Event|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
10876455|NCT00442364|BG000|Baseline|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
10876456|NCT00442364|FG000|Participant Flow|Polidocanol 1% Injectable Microfoam|polidocanol injectable microfoam 1%
10876457|NCT00442364|OG000|Outcome|Safety Evaluable Population|polidocanol injectable foam 1% with circulating MCA bubbles present at MRI
10876458|NCT00442364|EG000|Reported Event|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
10876459|NCT00442416|BG000|Baseline|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
10876460|NCT00442416|BG001|Baseline|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
10876461|NCT00442416|BG002|Baseline|Total|Total of all reporting groups
10876462|NCT00442416|FG000|Participant Flow|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
10876463|NCT00442416|FG001|Participant Flow|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
10992442|NCT01014403|EG000|Reported Event|Enoxaparin 30 mg SQ q12 Hours|"Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury.~enoxaparin: Enoxaparin 30 mg sq q 12 hours"
10992443|NCT01014403|EG001|Reported Event|Placebo|"vehicle administered sq q 12 hours~placebo: vehicle"
10992444|NCT01014442|BG000|Baseline|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992445|NCT01014442|BG001|Baseline|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992446|NCT01014442|BG002|Baseline|Total|Total of all reporting groups
10992447|NCT01014442|FG000|Participant Flow|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received mycophenolate mofetil (MMF) capsules at dose of 1.5 grams (g) twice daily (BID) from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992448|NCT01014442|FG001|Participant Flow|MMF - COPD, Emphysema, IPF, or A1AD|Participants with chronic obstructive pulmonary disorder (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992449|NCT01014442|OG000|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992450|NCT01014442|OG001|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992451|NCT01014442|OG001|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992452|NCT01014442|OG001|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992453|NCT01014442|OG001|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992454|NCT01014442|OG001|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
10992455|NCT01014442|EG000|Reported Event|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
10992456|NCT01014442|EG001|Reported Event|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
10992457|NCT01014455|BG000|Baseline|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
10992458|NCT01014455|BG001|Baseline|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
10992459|NCT01014455|BG002|Baseline|Total|Total of all reporting groups
10992460|NCT01014455|FG000|Participant Flow|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
10992461|NCT01014455|FG001|Participant Flow|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
10992462|NCT01014455|OG000|Outcome|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
10992463|NCT01014455|OG001|Outcome|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
10992464|NCT01014455|EG000|Reported Event|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
10992465|NCT01014455|EG001|Reported Event|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
10992466|NCT01014533|BG000|Baseline|Placebo|"Alcohol-dependent subjects spend 3 nights in the University of Michigan (UM) sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the University of Michigan (UM) Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
10992467|NCT01014533|BG001|Baseline|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
10992468|NCT01014533|BG002|Baseline|Total|Total of all reporting groups
11223244|NCT02352363|OG001|Outcome|Observational Cohort|"Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.~Observational cohort"
11223245|NCT02352363|EG000|Reported Event|CVT-301|"Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.~CVT-301"
10876464|NCT00442416|OG000|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
10876465|NCT00442416|OG001|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
10876466|NCT00442416|EG000|Reported Event|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
10876467|NCT00442416|EG001|Reported Event|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
10876468|NCT00442468|BG000|Baseline|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
10876469|NCT00442468|FG000|Participant Flow|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
10876470|NCT00442468|OG000|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
10876471|NCT00442468|EG000|Reported Event|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
10876472|NCT00442507|BG000|Baseline|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
10876473|NCT00442507|FG000|Participant Flow|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
10876474|NCT00442507|OG000|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
10876475|NCT00442507|EG000|Reported Event|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
10876476|NCT00442572|BG000|Baseline|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
10876477|NCT00442572|BG001|Baseline|No Intervention|Participants were on non- specific anti-viral treatment.
10876478|NCT00442572|BG002|Baseline|Total|Total of all reporting groups
10876479|NCT00442572|FG000|Participant Flow|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a (PEGASYS®). Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms (µg) in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously (SC) and followed by 12 weeks period without treatment.
10876480|NCT00442572|FG001|Participant Flow|No Intervention|Participants were on non- specific anti-viral treatment.
10876481|NCT00442572|OG000|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment..
10876482|NCT00442572|OG001|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
10876483|NCT00442572|OG000|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
10992469|NCT01014533|FG000|Participant Flow|Placebo|"Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
10992470|NCT01014533|FG001|Participant Flow|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 -2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
10992471|NCT01014533|OG000|Outcome|Placebo|"Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
10992472|NCT01014533|OG001|Outcome|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
10992473|NCT01014533|OG001|Outcome|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
10992474|NCT01014533|EG000|Reported Event|Placebo|"Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
10992475|NCT01014533|EG001|Reported Event|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
10992476|NCT01014585|BG000|Baseline|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment~One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
10992477|NCT01014585|BG001|Baseline|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
10992478|NCT01014585|BG002|Baseline|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
10992479|NCT01014585|BG003|Baseline|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment~One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population."
10992480|NCT01014585|BG004|Baseline|Total|Total of all reporting groups
10992481|NCT01014585|FG000|Participant Flow|Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Responders
10992482|NCT01014585|FG001|Participant Flow|Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Responders
10992483|NCT01014585|FG002|Participant Flow|Non-Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Non-Responders
10992484|NCT01014585|FG003|Participant Flow|Non-Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Non-Responders
10992485|NCT01014585|OG000|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
10992486|NCT01014585|OG001|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
10992487|NCT01014585|OG002|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
10992488|NCT01014585|OG003|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
10992489|NCT01014585|EG000|Reported Event|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment~One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
10992490|NCT01014585|EG001|Reported Event|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
10992491|NCT01014585|EG002|Reported Event|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
10992492|NCT01014585|EG003|Reported Event|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment~One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double blind investigational product and therefore was not included in the Safety population."
10992493|NCT01014624|BG000|Baseline|Prasugrel|Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days.
10992494|NCT01014624|BG001|Baseline|Clopidogrel|Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days.
10992495|NCT01014624|BG002|Baseline|Total|Total of all reporting groups
10992496|NCT01014624|FG000|Participant Flow|Prasugrel|Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days.
10992497|NCT01014624|FG001|Participant Flow|Clopidogrel|Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days.
10992498|NCT01014624|OG000|Outcome|Prasugrel|Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
10992499|NCT01014624|OG001|Outcome|Clopidogrel|Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
10992500|NCT01014624|OG000|Outcome|Prasugrel|Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days.
10992501|NCT01014624|OG001|Outcome|Clopidogrel|Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days.
10992502|NCT01014624|EG000|Reported Event|Prasugrel|Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days.
10992503|NCT01014624|EG001|Reported Event|Clopidogrel|Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days.
10992504|NCT01014689|BG000|Baseline|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
10992505|NCT01014689|BG001|Baseline|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
10992506|NCT01014689|BG002|Baseline|Total|Total of all reporting groups
10992507|NCT01014689|FG000|Participant Flow|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
10992508|NCT01014689|FG001|Participant Flow|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
10992509|NCT01014689|OG000|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
10992510|NCT01014689|OG001|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
10992511|NCT01014689|EG000|Reported Event|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
10992512|NCT01014689|EG001|Reported Event|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
10992513|NCT01014728|BG000|Baseline|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
10992514|NCT01014728|BG001|Baseline|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
10992515|NCT01014728|BG002|Baseline|Total|Total of all reporting groups
10992516|NCT01014728|FG000|Participant Flow|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
10992517|NCT01014728|FG001|Participant Flow|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
10992518|NCT01014728|OG000|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
10992519|NCT01014728|OG001|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
10992520|NCT01014728|EG000|Reported Event|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
10992521|NCT01014728|EG001|Reported Event|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
10992522|NCT01014741|BG000|Baseline|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
10992523|NCT01014741|BG001|Baseline|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
10992524|NCT01014741|BG002|Baseline|Total|Total of all reporting groups
10992525|NCT01014741|FG000|Participant Flow|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after pulmonary vein isolation (PVI) isolation prior to complex fractionated atrial electrograms (CFAE) ablation
10992526|NCT01014741|FG001|Participant Flow|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
10992527|NCT01014741|OG000|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
10992528|NCT01014741|OG001|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
10992529|NCT01014741|EG000|Reported Event|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
10992530|NCT01014741|EG001|Reported Event|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
10992531|NCT01014871|BG000|Baseline|Vistabel/Azzalure|"at Baseline:~1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead~1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
10992532|NCT01014871|FG000|Participant Flow|Vistabel/Azzalure|"at Baseline:~1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead~1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
10992533|NCT01014871|OG000|Outcome|Azzalure|"at Baseline:~- 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead"
10992534|NCT01014871|OG001|Outcome|Vistabel|"at Baseline:~- 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
10992535|NCT01014871|EG000|Reported Event|Azzalure|intra-individual comparison
10992536|NCT01014871|EG001|Reported Event|Vistabel|intra-individual comparison
11007408|NCT01090492|FG004|Participant Flow|SRP Cohort: Placebo First, Then PF-00489791 4 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007409|NCT01090492|FG005|Participant Flow|SRP Cohort: PF-00489791 4 mg First, Then Placebo|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007410|NCT01090492|FG006|Participant Flow|SRP Cohort: Placebo First, Then PF-00489791 20 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007411|NCT01090492|FG007|Participant Flow|SRP Cohort: PF-00489791 20 mg First, Then Placebo|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
11007412|NCT01090492|OG000|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
11007413|NCT01090492|OG001|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
11007414|NCT01090492|OG002|Outcome|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
11007415|NCT01090492|OG003|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007416|NCT01090492|OG004|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007417|NCT01090492|OG005|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007418|NCT01090492|OG000|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007419|NCT01090492|OG001|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007420|NCT01090492|OG002|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007421|NCT01090492|OG002|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007422|NCT01090492|OG003|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007423|NCT01090492|EG000|Reported Event|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
11007424|NCT01090492|EG001|Reported Event|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
11007425|NCT01090492|EG002|Reported Event|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
11007426|NCT01090492|EG003|Reported Event|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007427|NCT01090492|EG004|Reported Event|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007428|NCT01090492|EG005|Reported Event|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
11007429|NCT01090739|BG000|Baseline|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
11007430|NCT01090739|FG000|Participant Flow|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
11007431|NCT01090739|OG000|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
10992537|NCT01014910|BG000|Baseline|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
10992538|NCT01014910|BG001|Baseline|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
10992539|NCT01014910|BG002|Baseline|Total|Total of all reporting groups
10992540|NCT01014910|FG000|Participant Flow|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
10992541|NCT01014910|FG001|Participant Flow|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
10992542|NCT01014910|OG000|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
10992543|NCT01014910|OG001|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
10992544|NCT01014910|EG000|Reported Event|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
10992545|NCT01014910|EG001|Reported Event|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
10992546|NCT01014936|BG000|Baseline|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
10992547|NCT01014936|BG001|Baseline|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
10992548|NCT01014936|BG002|Baseline|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
10992549|NCT01014936|BG003|Baseline|Total|Total of all reporting groups
10992550|NCT01014936|FG000|Participant Flow|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
10992551|NCT01014936|FG001|Participant Flow|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
10992552|NCT01014936|FG002|Participant Flow|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
11099013|NCT01579162|EG003|Reported Event|NASH Patients With F0-F2 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11099014|NCT01579162|EG004|Reported Event|NASH Patients With F3-F4 Fibrosis|"Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123): The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"
11223246|NCT02352363|EG001|Reported Event|Observational Cohort|"Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.~Observational cohort"
11223247|NCT02352493|BG000|Baseline|Placebo - Single Ascending Dose|Healthy volunteers received a single dose of placebo (normal saline)
11223248|NCT02352493|BG001|Baseline|ALN-CC5 50mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 50mg
10876484|NCT00442572|EG000|Reported Event|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
10876485|NCT00442572|EG001|Reported Event|No Intervention|Participants were on non- specific anti-viral treatment.
10876486|NCT00442598|BG000|Baseline|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
10876487|NCT00442598|BG001|Baseline|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
10876488|NCT00442598|BG002|Baseline|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
10876489|NCT00442598|BG003|Baseline|Total|Total of all reporting groups
10876490|NCT00442598|FG000|Participant Flow|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
10876491|NCT00442598|FG001|Participant Flow|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
10876492|NCT00442598|FG002|Participant Flow|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
10876493|NCT00442598|OG000|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
10876494|NCT00442598|OG001|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
10876495|NCT00442598|OG002|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
10876496|NCT00442598|EG000|Reported Event|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
10876497|NCT00442598|EG001|Reported Event|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
10876498|NCT00442611|BG000|Baseline|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
10876499|NCT00442611|BG001|Baseline|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
10876500|NCT00442611|BG002|Baseline|Total|Total of all reporting groups
10876501|NCT00442611|FG000|Participant Flow|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
10876502|NCT00442611|FG001|Participant Flow|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
10876503|NCT00442611|OG000|Outcome|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
10876504|NCT00442611|OG001|Outcome|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
10876505|NCT00442611|EG000|Reported Event|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
10876506|NCT00442611|EG001|Reported Event|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
10876507|NCT00442689|BG000|Baseline|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
10876508|NCT00442689|BG001|Baseline|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
10876509|NCT00442689|BG002|Baseline|Placebo - 3|Placebo
10876510|NCT00442689|BG003|Baseline|Total|Total of all reporting groups
10876511|NCT00442689|FG000|Participant Flow|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)~Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
10876512|NCT00442689|FG001|Participant Flow|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
10876513|NCT00442689|FG002|Participant Flow|Placebo - 3|Placebo only
10876514|NCT00442689|OG000|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
10876515|NCT00442689|OG001|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
10876516|NCT00442689|OG002|Outcome|Placebo - 3|Placebo
10876517|NCT00442689|EG000|Reported Event|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)~Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
10876518|NCT00442689|EG001|Reported Event|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
10876519|NCT00442689|EG002|Reported Event|Placebo - 3|Placebo only
10879431|NCT00457743|BG002|Baseline|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
10879432|NCT00457743|BG003|Baseline|Total|Total of all reporting groups
10879433|NCT00457743|FG000|Participant Flow|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
10879434|NCT00457743|FG001|Participant Flow|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
10879435|NCT00457743|FG002|Participant Flow|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
10879436|NCT00457743|OG000|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
10879437|NCT00457743|OG001|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
10879438|NCT00457743|OG002|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
10879439|NCT00457743|OG000|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
10879440|NCT00457743|EG000|Reported Event|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
10992553|NCT01014936|OG000|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
10992554|NCT01014936|OG001|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
10992555|NCT01014936|OG002|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
10992556|NCT01014936|OG000|Outcome|MSC2156119J Combined|All subjects who were administered with micronized or non-micronized MSC2156119J (capsule or tablet formulation) in any of the three regimens.
10992557|NCT01014936|OG000|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
10992558|NCT01014936|OG001|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
10992559|NCT01014936|OG002|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
10992560|NCT01014936|OG003|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
10992561|NCT01014936|OG004|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
10992562|NCT01014936|OG005|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
10992563|NCT01014936|OG006|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
10992564|NCT01014936|OG007|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
10992565|NCT01014936|OG008|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
10992566|NCT01014936|OG009|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
10992567|NCT01014936|OG010|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
10992568|NCT01014936|OG011|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
10992569|NCT01014936|OG000|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
10992570|NCT01014936|OG001|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
10992571|NCT01014936|OG002|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
10992572|NCT01014936|OG003|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
10992573|NCT01014936|OG004|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
10992574|NCT01014936|OG005|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
10992575|NCT01014936|OG006|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
10992576|NCT01014936|OG007|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
10992577|NCT01014936|OG008|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
10992578|NCT01014936|OG000|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
10992579|NCT01014936|OG001|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
10992580|NCT01014936|OG002|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
10992581|NCT01014936|OG003|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
10992582|NCT01014936|OG004|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
10992583|NCT01014936|OG005|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
10992584|NCT01014936|OG006|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
10992585|NCT01014936|OG007|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
10992586|NCT01014936|OG005|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
10992587|NCT01014936|OG006|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
10992588|NCT01014936|OG007|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
10992589|NCT01014936|OG002|Outcome|MSC2156119J 130 mg Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
10992590|NCT01014936|OG007|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state
10992591|NCT01014936|OG000|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg with food.
10992592|NCT01014936|OG001|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg in the fasted state.
10992593|NCT01014936|OG002|Outcome|MSC2156119J 500 mg Fed|Subjects were administered with micronized MSC2156119J 500 mg with food.
10992594|NCT01014936|OG003|Outcome|MSC2156119J 700 mg Fed|Subjects were administered with micronized MSC2156119J 700 mg with food.
10992595|NCT01014936|OG004|Outcome|MSC2156119J 1000 mg Fed|Subjects were administered with micronized MSC2156119J 1000 mg with food.
10992596|NCT01014936|OG005|Outcome|MSC2156119J 1200 mg Fasted|Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state.
10992597|NCT01014936|OG006|Outcome|MSC2156119J 1400 mg Fed|Subjects were administered with micronized MSC2156119J 1400 mg with food.
10992598|NCT01014936|OG007|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet) with food.
10992599|NCT01014936|OG000|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food
10992600|NCT01014936|OG008|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg in the fasted state.
10992601|NCT01014936|OG001|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
10992602|NCT01014936|OG000|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
10992603|NCT01014936|OG003|Outcome|MSC2156119J 145 mg Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
10992604|NCT01014936|OG004|Outcome|MSC2156119J 215 mg Fed|Subjects were administered with micronized MSC2156119J 215 mg with food.
10992605|NCT01014936|OG005|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
10992606|NCT01014936|OG006|Outcome|MSC2156119J 400 mg Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
10992607|NCT01014936|OG009|Outcome|MSC2156119J 115 mg Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
10992608|NCT01014936|OG007|Outcome|MSC2156119J 115 mg Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
10992609|NCT01014936|OG000|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg with food
10992610|NCT01014936|OG002|Outcome|MSC2156119J 500 mg Fed|Subjects were administered with micronized MSC2156119J 500 mg with food
10992611|NCT01014936|OG007|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (Tablet) with food.
10992612|NCT01014936|OG008|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
10992613|NCT01014936|OG008|Outcome|MSC2156119J 115 mg Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
10992614|NCT01014936|EG000|Reported Event|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
10992615|NCT01014936|EG001|Reported Event|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
10992616|NCT01014936|EG002|Reported Event|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
10992617|NCT01014975|BG000|Baseline|Safety Population|Plasmin (Human): Plasmin (Human), 20 mg, 40 mg, or 80 mg, delivered through a catheter into a thrombus
10992618|NCT01014975|FG000|Participant Flow|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
10992619|NCT01014975|FG001|Participant Flow|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
10992620|NCT01014975|FG002|Participant Flow|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
10992621|NCT01014975|OG000|Outcome|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
10992622|NCT01014975|OG001|Outcome|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
10992623|NCT01014975|OG002|Outcome|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
10992624|NCT01014975|EG000|Reported Event|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
10992625|NCT01014975|EG001|Reported Event|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
10992626|NCT01014975|EG002|Reported Event|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
10992627|NCT01014988|BG000|Baseline|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992628|NCT01014988|BG001|Baseline|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992629|NCT01014988|BG002|Baseline|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992630|NCT01014988|BG003|Baseline|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992631|NCT01014988|BG004|Baseline|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992632|NCT01014988|BG005|Baseline|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10846481|NCT00276406|OG000|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
10992633|NCT01014988|BG006|Baseline|Total|Total of all reporting groups
10992634|NCT01014988|FG000|Participant Flow|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 milligrams (mg) zanamivir by intravenous (IV) infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992635|NCT01014988|FG001|Participant Flow|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992636|NCT01014988|FG002|Participant Flow|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992637|NCT01014988|FG003|Participant Flow|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992638|NCT01014988|FG004|Participant Flow|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992639|NCT01014988|FG005|Participant Flow|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992640|NCT01014988|OG000|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992641|NCT01014988|OG001|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992642|NCT01014988|OG000|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
10992643|NCT01014988|OG001|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
10992644|NCT01014988|OG002|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992645|NCT01014988|OG003|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992646|NCT01014988|OG004|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992647|NCT01014988|OG005|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992648|NCT01014988|OG006|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992649|NCT01014988|OG001|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992650|NCT01014988|OG002|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992651|NCT01014988|OG003|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992652|NCT01014988|OG004|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992653|NCT01014988|OG005|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992654|NCT01014988|EG000|Reported Event|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992655|NCT01014988|EG001|Reported Event|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992656|NCT01014988|EG002|Reported Event|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992657|NCT01014988|EG003|Reported Event|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992658|NCT01014988|EG004|Reported Event|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992659|NCT01014988|EG005|Reported Event|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
10992660|NCT01015118|BG000|Baseline|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
10992661|NCT01015118|BG001|Baseline|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
10992662|NCT01015118|BG002|Baseline|Total|Total of all reporting groups
10992663|NCT01015118|FG000|Participant Flow|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
10992664|NCT01015118|FG001|Participant Flow|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
10992665|NCT01015118|OG000|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
10992666|NCT01015118|OG001|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
10992667|NCT01015118|EG000|Reported Event|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
10992668|NCT01015118|EG001|Reported Event|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
10992669|NCT01015131|BG000|Baseline|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
10992670|NCT01015131|FG000|Participant Flow|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
10992671|NCT01015131|OG000|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
10992672|NCT01015131|EG000|Reported Event|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
10992673|NCT01015170|BG000|Baseline|Buproprion & Behavioural Support|8 weeks of buproprion-SR + brief counselling for smoking cessation
10992674|NCT01015170|FG000|Participant Flow|Bupropion HCl|"Up to 8 week of bupropion SR (150mg BID) + counseling.~bupropion HCl: 150mg BID for up to 8 weeks + counseling"
10992675|NCT01015170|OG000|Outcome|Nicotine Replacement & Behavioural Support|"Nicotine Replacement Therapy: Transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge~& Smoking cessation counselling-relapse prevention strategies."
10992676|NCT01015170|OG000|Outcome|Bupropion HCl and Counselling|Bupropion HCl Up to 8 week of bupropion SR (150mg BID) + counseling.
10992677|NCT01015170|OG000|Outcome|Buproprion & Behavioural Support|8 weeks of buproprion-SR + brief counselling for smoking cessation
10992678|NCT01015170|EG000|Reported Event|Bupropion HCl|"Up to 8 week of bupropion SR (150mg BID) + counseling.~bupropion HCl: 150mg BID for up to 8 weeks + counseling"
10992679|NCT01015287|BG000|Baseline|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992680|NCT01015287|BG001|Baseline|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992681|NCT01015287|BG002|Baseline|Total|Total of all reporting groups
10992682|NCT01015287|FG000|Participant Flow|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992683|NCT01015287|FG001|Participant Flow|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992684|NCT01015287|OG000|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992685|NCT01015287|OG001|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992686|NCT01015287|OG000|Outcome|Non Pre-treatment|A placebo LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992687|NCT01015287|OG000|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992688|NCT01015287|EG000|Reported Event|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992689|NCT01015287|EG001|Reported Event|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
10992690|NCT01015326|BG000|Baseline|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
10992691|NCT01015326|BG001|Baseline|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
10992692|NCT01015326|BG002|Baseline|Total|Total of all reporting groups
10992693|NCT01015326|FG000|Participant Flow|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
10992694|NCT01015326|FG001|Participant Flow|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked through interview and questionnaire to rate items according to how important they are to the patient's health-related quality of life (HRQL).~Questionnaire : Administered questionnaire"
10992695|NCT01015326|OG000|Outcome|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
11007432|NCT01090739|OG000|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
10992696|NCT01015326|OG001|Outcome|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
10992697|NCT01015326|EG000|Reported Event|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
10992698|NCT01015326|EG001|Reported Event|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
10992699|NCT01015443|BG000|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
10992700|NCT01015443|BG001|Baseline|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
10992701|NCT01015443|BG002|Baseline|Total|Total of all reporting groups
10992702|NCT01015443|FG000|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Supportive Care|A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 microgram (mcg) and then at 6-Week interval, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinued for any other reason. The best supportive care (BSC) was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
10992703|NCT01015443|FG001|Participant Flow|Saline + Placebo + BSC|A single IV infusion of 0.9 percent (%) sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
10992704|NCT01015443|OG000|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
10992705|NCT01015443|OG001|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
10992706|NCT01015443|EG000|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
10846482|NCT00276406|OG001|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
10992707|NCT01015443|EG001|Reported Event|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
10992708|NCT01015534|BG000|Baseline|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
10992709|NCT01015534|BG001|Baseline|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
10992710|NCT01015534|BG002|Baseline|Total|Total of all reporting groups
10992711|NCT01015534|FG000|Participant Flow|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
10992712|NCT01015534|FG001|Participant Flow|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
10992713|NCT01015534|OG000|Outcome|Whole Brain Irradiation and Temozolomide|Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
10992714|NCT01015534|OG001|Outcome|Whole Brain Irradiation|Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
10992715|NCT01015534|OG000|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
10992716|NCT01015534|OG001|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
10992717|NCT01015534|OG000|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks,and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
10992718|NCT01015534|EG000|Reported Event|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
10992719|NCT01015534|EG001|Reported Event|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
10992720|NCT01015560|BG000|Baseline|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
10992721|NCT01015560|FG000|Participant Flow|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
10992722|NCT01015560|OG000|Outcome|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
10992723|NCT01015560|EG000|Reported Event|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
10992724|NCT01015586|BG000|Baseline|Lamotrigine|"Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks~Lamotrigine: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks"
10992725|NCT01015586|BG001|Baseline|Placebo|"Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks~Placebo: Placebo once daily for 12 weeks"
10992726|NCT01015586|BG002|Baseline|Total|Total of all reporting groups
10992727|NCT01015586|FG000|Participant Flow|Lamotrigine|"Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks~Lamotrigine: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks"
10992728|NCT01015586|FG001|Participant Flow|Placebo|"Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks~Placebo: Placebo once daily for 12 weeks"
10992729|NCT01015586|OG000|Outcome|Lamotrigine|"Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks~Lamotrigine: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks"
10992730|NCT01015586|OG001|Outcome|Placebo|"Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks~Placebo: Placebo once daily for 12 weeks"
10992731|NCT01015586|EG000|Reported Event|Lamotrigine|"Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks~Lamotrigine: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks"
10992732|NCT01015586|EG001|Reported Event|Placebo|"Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks~Placebo: Placebo once daily for 12 weeks"
10992733|NCT01015612|BG000|Baseline|Medtronic CoreValve® System Implantation|"Patients with symptomatic severe aortic stenosis who have an elevated surgical risk~Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk"
11007433|NCT01090739|EG000|Reported Event|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
10992734|NCT01015612|FG000|Participant Flow|Medtronic CoreValve® System Implantation|"Patients with symptomatic severe aortic stenosis who have an elevated surgical risk~Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk"
10992735|NCT01015612|OG000|Outcome|Medtronic CoreValve® System Implantation|"Patients with symptomatic severe aortic stenosis who have an elevated surgical risk~Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk"
10992736|NCT01015612|EG000|Reported Event|Medtronic CoreValve® System Implantation|"Patients with symptomatic severe aortic stenosis who have an elevated surgical risk~Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk"
10992737|NCT01015638|BG000|Baseline|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
10992738|NCT01015638|BG001|Baseline|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
10992739|NCT01015638|BG002|Baseline|Total|Total of all reporting groups
10992740|NCT01015638|FG000|Participant Flow|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
10992741|NCT01015638|FG001|Participant Flow|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
10992742|NCT01015638|OG000|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
10992743|NCT01015638|OG001|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
10992744|NCT01015638|EG000|Reported Event|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
10992745|NCT01015638|EG001|Reported Event|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
10992746|NCT01015677|BG000|Baseline|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
10992747|NCT01015677|BG001|Baseline|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
10992748|NCT01015677|BG002|Baseline|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
10992749|NCT01015677|BG003|Baseline|Total|Total of all reporting groups
10992750|NCT01015677|FG000|Participant Flow|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
10992751|NCT01015677|FG001|Participant Flow|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
10992752|NCT01015677|FG002|Participant Flow|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
10992753|NCT01015677|OG000|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
10992754|NCT01015677|OG001|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
10992755|NCT01015677|OG002|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
10992756|NCT01015677|EG000|Reported Event|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
10992757|NCT01015677|EG001|Reported Event|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
10992758|NCT01015677|EG002|Reported Event|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
10992759|NCT01015703|BG000|Baseline|1 mg Dose|1 mg CoVaccine HT
10992760|NCT01015703|BG001|Baseline|2 mg Dose|2 mg CoVaccine HT
10992761|NCT01015703|BG002|Baseline|5 mg Dose|5 mg CoVaccine HT
10992762|NCT01015703|BG003|Baseline|7 mg Dose|7 mg CoVaccine HT
10992763|NCT01015703|BG004|Baseline|10 mg Dose|10 mg CoVaccine HT
10992764|NCT01015703|BG005|Baseline|Total|Total of all reporting groups
10992765|NCT01015703|FG000|Participant Flow|1 mg Dose|1 mg CoVaccine HT
10992766|NCT01015703|FG001|Participant Flow|2 mg Dose|2 mg CoVaccine HT
10992767|NCT01015703|FG002|Participant Flow|5 mg Dose|5 mg CoVaccine HT
10992768|NCT01015703|FG003|Participant Flow|7 mg Dose|7 mg CoVaccine HT
10992769|NCT01015703|FG004|Participant Flow|10 mg Dose|10 mg CoVaccine HT
10992770|NCT01015703|OG000|Outcome|1 mg Dose|1 mg CoVaccine HT
10992771|NCT01015703|OG001|Outcome|2 mg Dose|2 mg CoVaccine HT
10992772|NCT01015703|OG002|Outcome|5 mg Dose|5 mg CoVaccine HT
10992773|NCT01015703|OG003|Outcome|7 mg Dose|7 mg CoVaccine HT
10992774|NCT01015703|OG004|Outcome|10 mg Dose|10 mg CoVaccine HT
10992775|NCT01015703|EG000|Reported Event|1 mg Dose|1 mg CoVaccine HT
10992776|NCT01015703|EG001|Reported Event|2 mg Dose|2 mg CoVaccine HT
10992777|NCT01015703|EG002|Reported Event|5 mg Dose|5 mg CoVaccine HT
10992778|NCT01015703|EG003|Reported Event|7 mg Dose|7 mg CoVaccine HT
10992779|NCT01015703|EG004|Reported Event|10 mg Dose|10 mg CoVaccine HT
10992780|NCT01015768|BG000|Baseline|All Participants|"A new lens (PureVision) is soaked in ReNu Multiplus multipurpose soaking solution~A new lens (PureVision) is soaked for 2 hours in non-preserved saline"
10992781|NCT01015768|FG000|Participant Flow|Test Eye|A new PureVision contact lens is soaked in ReNu Multiplus disinfecting solution and worn for 8 hours
10992782|NCT01015768|FG001|Participant Flow|Control|A new PureVision contact lens is soaked in non-preserved saline and worn for 8 hours
10992783|NCT01015768|OG000|Outcome|PHMB-containing Disinfectant|New lens soaked in B&L ReNu Multiplus disinfecting solution.
10992784|NCT01015768|OG001|Outcome|Non-preserved Saline|New lens soaked for two hours in non-preserved saline
10992785|NCT01015768|OG000|Outcome|Test Eye|Uses ReNu Multiplus as multipurpose soaking solution
10992786|NCT01015768|OG001|Outcome|Control|A new lens (PureVision) is soaked for 2 hours in non-preserved saline
10992787|NCT01015768|EG000|Reported Event|Test Eye|Uses ReNu Multiplus as multipurpose soaking solution
10992788|NCT01015768|EG001|Reported Event|Control|A new lens (PureVision) is soaked for 2 hours in non-preserved saline
10992789|NCT01015781|BG000|Baseline|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
10992790|NCT01015781|BG001|Baseline|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
10992791|NCT01015781|BG002|Baseline|Total|Total of all reporting groups
10992792|NCT01015781|FG000|Participant Flow|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
10992793|NCT01015781|FG001|Participant Flow|Wait List Control|Wait List Control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
10992794|NCT01015781|OG000|Outcome|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
10992795|NCT01015781|OG001|Outcome|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
10992796|NCT01015781|EG000|Reported Event|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
10992797|NCT01015781|EG001|Reported Event|Wait List Control|Wait List control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.
10992798|NCT01015807|BG000|Baseline|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
10992799|NCT01015807|BG001|Baseline|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
10992800|NCT01015807|BG002|Baseline|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
10992801|NCT01015807|BG003|Baseline|Total|Total of all reporting groups
10992802|NCT01015807|FG000|Participant Flow|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
10992803|NCT01015807|FG001|Participant Flow|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
10992804|NCT01015807|FG002|Participant Flow|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
10992805|NCT01015807|OG000|Outcome|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
10992806|NCT01015807|OG001|Outcome|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
10992807|NCT01015807|OG002|Outcome|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
10992808|NCT01015807|EG000|Reported Event|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
10992809|NCT01015807|EG001|Reported Event|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
11007434|NCT01090752|BG000|Baseline|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
10992810|NCT01015807|EG002|Reported Event|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
10992811|NCT01015820|BG000|Baseline|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
10992812|NCT01015820|BG001|Baseline|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
10992813|NCT01015820|BG002|Baseline|Total|Total of all reporting groups
10992814|NCT01015820|FG000|Participant Flow|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.
10992815|NCT01015820|FG001|Participant Flow|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
10992816|NCT01015820|OG000|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
10992817|NCT01015820|OG001|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
10992818|NCT01015820|EG000|Reported Event|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
10992819|NCT01015820|EG001|Reported Event|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
10992820|NCT01015976|BG000|Baseline|Active Drug|"Single arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
10992821|NCT01015976|FG000|Participant Flow|Experimental|Post surgery group Sertraline : Single dose of 100mg sertraline
10992822|NCT01015976|FG001|Participant Flow|Control Group|"active drug~No surgery matched subjects"
10992823|NCT01015976|OG000|Outcome|Control|"Single arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
10992824|NCT01015976|EG000|Reported Event|Active Drug|"Two arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
10992825|NCT01016015|BG000|Baseline|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10992826|NCT01016015|FG000|Participant Flow|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10992827|NCT01016015|OG000|Outcome|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10992828|NCT01016015|EG000|Reported Event|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10992829|NCT01016067|BG000|Baseline|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
10992830|NCT01016067|BG001|Baseline|Autograft Bone|Patients received autograft bone with rigid internal fixation.
10992831|NCT01016067|BG002|Baseline|Total|Total of all reporting groups
10992832|NCT01016067|FG000|Participant Flow|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
10992833|NCT01016067|FG001|Participant Flow|Autograft Bone|Patients received autograft bone with rigid internal fixation.
10992834|NCT01016067|OG000|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
10992835|NCT01016067|OG001|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
10992836|NCT01016067|EG000|Reported Event|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
10992837|NCT01016067|EG001|Reported Event|Autograft Bone|Patients received autograft bone with rigid internal fixation.
10992838|NCT01016106|BG000|Baseline|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
10992839|NCT01016106|BG001|Baseline|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
10992840|NCT01016106|BG002|Baseline|Total|Total of all reporting groups
10992841|NCT01016106|FG000|Participant Flow|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
10992842|NCT01016106|FG001|Participant Flow|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
10992843|NCT01016106|OG000|Outcome|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
10992844|NCT01016106|OG001|Outcome|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
10876520|NCT00442702|BG000|Baseline|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
10876521|NCT00442702|BG001|Baseline|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
10876522|NCT00442702|BG002|Baseline|Total|Total of all reporting groups
10876523|NCT00442702|FG000|Participant Flow|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
10876524|NCT00442702|FG001|Participant Flow|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
10876525|NCT00442702|OG000|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
10876526|NCT00442702|OG001|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
10876527|NCT00442702|EG000|Reported Event|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
10876528|NCT00442702|EG001|Reported Event|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
10876529|NCT00442767|BG000|Baseline|Insulin Therpy / Pramlintide + Insulin Therapy|"Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.~Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%."
10876530|NCT00442767|FG000|Participant Flow|Insulin Therapy / Pramlintide + Insulin Therapy|"Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.~Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%."
10876531|NCT00442767|OG000|Outcome|Rapid Acting Insulin Therapy - Before Meal|Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.
10876532|NCT00442767|OG001|Outcome|Pre-meal Pramlintide and Post-meal Insulin Therapy|Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
10876533|NCT00442767|EG000|Reported Event|Insulin Therapy|Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.
10876534|NCT00442767|EG001|Reported Event|Pramlintide + Insulin Therapy|Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
10876535|NCT00442936|BG000|Baseline|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
10876536|NCT00442936|BG001|Baseline|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
10876537|NCT00442936|BG002|Baseline|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
10992845|NCT01016106|EG000|Reported Event|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
10992846|NCT01016106|EG001|Reported Event|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
10992847|NCT01016132|BG000|Baseline|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
10992848|NCT01016132|FG000|Participant Flow|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
10992849|NCT01016132|OG000|Outcome|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
10992850|NCT01016132|EG000|Reported Event|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
10992851|NCT01016262|BG000|Baseline|MAX-002 (Double-blind Phase)|MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992852|NCT01016262|BG001|Baseline|Canasa® (Double-blind Phase)|Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992853|NCT01016262|BG002|Baseline|Placebo (Double-blind Phase)|Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase
10992854|NCT01016262|BG003|Baseline|Total|Total of all reporting groups
10992855|NCT01016262|FG000|Participant Flow|MAX-002 (Double-blind Phase)|MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992856|NCT01016262|FG001|Participant Flow|Canasa® (Double-blind Phase)|Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992857|NCT01016262|FG002|Participant Flow|Placebo (Double-blind Phase)|Matching placebo suppository rectally once daily at bedtime, for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992858|NCT01016262|FG003|Participant Flow|MAX-002 (Open-label Phase)|Participants who completed or discontinued DB phase and provided consent, received MAX-002 suppository 1 g once daily at bedtime for 8 weeks during the OL phase.
10992859|NCT01016262|FG004|Participant Flow|Standard Care Treatment (Open-label Phase)|Participants who completed or discontinued the DB phase and provided consent, received standard care treatment once daily for 8 weeks as per investigator's judgment during the OL phase.
10992860|NCT01016262|FG005|Participant Flow|No Treatment (Open-label Phase)|Participants who completed or discontinued the DB phase and provided consent, received no treatment for 8 weeks as per investigator's judgment during OL phase.
10992861|NCT01016262|OG000|Outcome|MAX-002 (Double-blind Phase)|MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992862|NCT01016262|OG001|Outcome|Canasa® (Double-blind Phase)|Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992863|NCT01016262|OG002|Outcome|Placebo (Double-blind Phase)|Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase
10992864|NCT01016262|EG000|Reported Event|MAX-002 (Double-blind Phase)|MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992865|NCT01016262|EG001|Reported Event|Canasa® (Double-blind Phase)|Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992866|NCT01016262|EG002|Reported Event|Placebo (Double-blind Phase)|Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DL phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
10992867|NCT01016262|EG003|Reported Event|MAX-002 (Open-label Phase)|Participants who completed or discontinued the DB phase and provided consent, received MAX-002 suppository 1 g once daily at bedtime for 8 weeks during the OL phase.
10992868|NCT01016262|EG004|Reported Event|Standard Care Treatment (Open-label Phase)|Participants who completed or discontinued the DB phase and provided consent, received standard care treatment once daily for 8 weeks as per investigator's judgment during the OL phase.
10992869|NCT01016262|EG005|Reported Event|No Treatment (Open-label Phase)|Participants who completed or discontinued the DB phase and provided consent, received no treatment for 8 weeks as per investigator's judgment during OL phase.
10992870|NCT01016353|BG000|Baseline|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
10992871|NCT01016353|BG001|Baseline|BVPT|Barker's vacuum-packing technique (BVPT)
10992872|NCT01016353|BG002|Baseline|Total|Total of all reporting groups
10992873|NCT01016353|FG000|Participant Flow|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
10992874|NCT01016353|FG001|Participant Flow|BVPT|Barker's vacuum-packing technique (BVPT)
10992875|NCT01016353|OG000|Outcome|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
10992876|NCT01016353|OG001|Outcome|BVPT|Barker's vacuum-packing technique (BVPT)
10992877|NCT01016353|EG000|Reported Event|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
10992878|NCT01016353|EG001|Reported Event|BVPT|Barker's vacuum-packing technique (BVPT)
10992879|NCT01016483|BG000|Baseline|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992880|NCT01016483|BG001|Baseline|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992881|NCT01016483|BG002|Baseline|Phase II: Arm 1 (Gemcitabine + Placebo)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
10992882|NCT01016483|BG003|Baseline|Phase II: Arm 2 (Gemcitabine + Pimasertib)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
10992883|NCT01016483|BG004|Baseline|Total|Total of all reporting groups
10992884|NCT01016483|FG000|Participant Flow|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992885|NCT01016483|FG001|Participant Flow|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks) (bid continuous regimen).
10992886|NCT01016483|FG002|Participant Flow|Phase II: Arm 1 (Gemcitabine + Placebo)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
10992887|NCT01016483|FG003|Participant Flow|Phase II: Arm 2 (Gemcitabine + Pimasertib)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
10992888|NCT01016483|OG000|Outcome|Safety Run-in Part Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992889|NCT01016483|OG001|Outcome|Safety Run-in Part Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992890|NCT01016483|OG002|Outcome|Safety Run-in Part Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992891|NCT01016483|OG003|Outcome|Safety Run-in Part Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992892|NCT01016483|OG004|Outcome|Safety Run-in Part Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992893|NCT01016483|OG005|Outcome|Safety Run-in Part Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992894|NCT01016483|OG006|Outcome|Safety Run-in Part Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
10992895|NCT01016483|OG007|Outcome|Safety Run-in Part Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
10992896|NCT01016483|OG000|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
10992897|NCT01016483|OG001|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
10992898|NCT01016483|OG000|Outcome|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992899|NCT01016483|OG001|Outcome|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992900|NCT01016483|OG000|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992901|NCT01016483|OG001|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992902|NCT01016483|OG002|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992903|NCT01016483|OG003|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992904|NCT01016483|OG004|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992905|NCT01016483|OG005|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992906|NCT01016483|OG000|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992907|NCT01016483|OG003|Outcome|Regimen 1: 68 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 68 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
10992908|NCT01016483|OG004|Outcome|Regimen 1: 90 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 90 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
10992909|NCT01016483|OG005|Outcome|Regimen 1: 120 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 120 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
10992910|NCT01016483|OG001|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992911|NCT01016483|OG002|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992912|NCT01016483|OG003|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992913|NCT01016483|OG000|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992914|NCT01016483|OG005|Outcome|Regimen1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992915|NCT01016483|OG000|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
10992916|NCT01016483|OG001|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
10992917|NCT01016483|OG001|Outcome|Regimen 1: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
10992918|NCT01016483|OG000|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
10992919|NCT01016483|OG001|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
10992920|NCT01016483|EG000|Reported Event|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992921|NCT01016483|EG001|Reported Event|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
10992922|NCT01016483|EG002|Reported Event|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib orally 60 mg bid - continuous regimen.
10992923|NCT01016483|EG003|Reported Event|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib orally 60 mg bid - continuous regimen.
10992924|NCT01016600|BG000|Baseline|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992925|NCT01016600|BG001|Baseline|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992926|NCT01016600|BG002|Baseline|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992927|NCT01016600|BG003|Baseline|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992928|NCT01016600|BG004|Baseline|Total|Total of all reporting groups
10992929|NCT01016600|FG000|Participant Flow|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992930|NCT01016600|FG001|Participant Flow|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992931|NCT01016600|FG002|Participant Flow|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992932|NCT01016600|FG003|Participant Flow|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992933|NCT01016600|OG000|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992934|NCT01016600|OG001|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992935|NCT01016600|OG002|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992936|NCT01016600|OG003|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992937|NCT01016600|OG000|Outcome|Phase I Cohort|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992938|NCT01016600|EG000|Reported Event|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992939|NCT01016600|EG001|Reported Event|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992940|NCT01016600|EG002|Reported Event|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992941|NCT01016600|EG003|Reported Event|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
10992942|NCT01016652|BG000|Baseline|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
10992943|NCT01016652|BG001|Baseline|Etafilcon A Sphere\ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.~Repeat for the second lens (multifocal)."
10992944|NCT01016652|BG002|Baseline|Total|Total of all reporting groups
10992945|NCT01016652|FG000|Participant Flow|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
10992946|NCT01016652|FG001|Participant Flow|Etafilcon A Sphere/ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.~Repeat for the second lens (multifocal)."
10992947|NCT01016652|OG000|Outcome|Etafilcon A Multifocal|etafilcon A multifocal worn.
10992948|NCT01016652|OG001|Outcome|Etafilcon A Sphere|etafilcon A sphere worn
10992949|NCT01016652|OG000|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
10992950|NCT01016652|OG001|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
10992951|NCT01016652|EG000|Reported Event|Etafilcon A Multifocal|etafilcon A multifocal worn
10992952|NCT01016652|EG001|Reported Event|Etafilcon A Sphere|etafilcon A sphere worn
10992953|NCT01016678|BG000|Baseline|Adolescents Age 12-17|All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average
10992954|NCT01016678|FG000|Participant Flow|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
10992955|NCT01016678|FG001|Participant Flow|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
10992956|NCT01016678|FG002|Participant Flow|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
10992957|NCT01016678|FG003|Participant Flow|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
10992958|NCT01016678|FG004|Participant Flow|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~All migraines (up to four) will be treated with active treximet"
10992959|NCT01016678|OG000|Outcome|Migraine Attack 1|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
10992960|NCT01016678|OG001|Outcome|Migraine Attack 2|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
11007435|NCT01090752|BG001|Baseline|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
11007436|NCT01090752|BG002|Baseline|Total|Total of all reporting groups
11007437|NCT01090752|FG000|Participant Flow|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
10992961|NCT01016678|OG002|Outcome|Migraine Attack 3|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
10992962|NCT01016678|OG003|Outcome|Migraine Attack 4|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
10992963|NCT01016678|OG000|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
10992964|NCT01016678|OG001|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
10992965|NCT01016678|OG000|Outcome|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
10992966|NCT01016678|OG001|Outcome|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
10992967|NCT01016678|OG002|Outcome|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
10992968|NCT01016678|OG003|Outcome|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
10992969|NCT01016678|OG004|Outcome|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~All migraines (up to four) will be treated with active treximet"
10992970|NCT01016678|EG000|Reported Event|Active, Active, Active, Placebo|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
10992971|NCT01016678|EG001|Reported Event|Active, Active, Placebo, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
10992972|NCT01016678|EG002|Reported Event|Active, Placebo, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
10992973|NCT01016678|EG003|Reported Event|Placebo, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
10992974|NCT01016678|EG004|Reported Event|Active, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
10992975|NCT01016691|BG000|Baseline|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
10992976|NCT01016691|BG001|Baseline|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
10992977|NCT01016691|BG002|Baseline|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
10992978|NCT01016691|BG003|Baseline|Total|Total of all reporting groups
10992979|NCT01016691|FG000|Participant Flow|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
10992980|NCT01016691|FG001|Participant Flow|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
10992981|NCT01016691|FG002|Participant Flow|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
10992982|NCT01016691|OG000|Outcome|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
10992983|NCT01016691|OG001|Outcome|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
10992984|NCT01016691|OG002|Outcome|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
10992985|NCT01016691|EG000|Reported Event|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
10992986|NCT01016691|EG001|Reported Event|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
10992987|NCT01016691|EG002|Reported Event|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
10992988|NCT01016769|BG000|Baseline|Phase 1, Dose Level 1|Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5
10992989|NCT01016769|BG001|Baseline|Phase 1, Dose Level 2|Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC
10992990|NCT01016769|BG002|Baseline|Phase 1, Dose Level 3|Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
10992991|NCT01016769|BG003|Baseline|Phase 2, Dose Level 3|Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
10992992|NCT01016769|BG004|Baseline|Total|Total of all reporting groups
10992993|NCT01016769|FG000|Participant Flow|Phase 1, Dose Level 1|Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5
10992994|NCT01016769|FG001|Participant Flow|Phase 1, Dose Level 2|Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC
10992995|NCT01016769|FG002|Participant Flow|Phase 1, Dose Level 3|Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
10992996|NCT01016769|FG003|Participant Flow|Phase 2, Dose Level 3|Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
10992997|NCT01016769|OG000|Outcome|Temsirolimus + Weekly Paclitaxel + Carboplatin|In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed.
10992998|NCT01016769|OG000|Outcome|Temsirolimus + Weekly Paclitaxel + Carboplatin|"In Part 1 (Phase I) of the study, the primary endpoint is to establish the phase II recommended dose for the combination of temsirolimus + weekly paclitaxel + carboplatinPart 1 (Phase I) features a standard 3 + 3 phase I dose escalation design. Up to 3 dose levels are planned in the Phase I portion of the study.~In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed."
10992999|NCT01016769|OG000|Outcome|Temsirolimus + Weekly Paclitaxel + Carboplatin|Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed.
10993000|NCT01016769|EG000|Reported Event|Phase 1, Dose Level 1|Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5
10993001|NCT01016769|EG001|Reported Event|Phase 1, Dose Level 2|Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC
10993002|NCT01016769|EG002|Reported Event|Phase 1, Dose Level 3|Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
10993003|NCT01016769|EG003|Reported Event|Phase 2, Dose Level 3|Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
10993004|NCT01016834|BG000|Baseline|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
10993005|NCT01016834|FG000|Participant Flow|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
10993006|NCT01016834|OG000|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
10993007|NCT01016834|EG000|Reported Event|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
10993008|NCT01016873|BG000|Baseline|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993009|NCT01016873|BG001|Baseline|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993010|NCT01016873|BG002|Baseline|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993011|NCT01016873|BG003|Baseline|Total|Total of all reporting groups
10993012|NCT01016873|FG000|Participant Flow|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993013|NCT01016873|FG001|Participant Flow|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993014|NCT01016873|FG002|Participant Flow|Sham IRay|"Sham 24 or 16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993015|NCT01016873|OG000|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993016|NCT01016873|OG001|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993017|NCT01016873|OG002|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993018|NCT01016873|EG000|Reported Event|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993019|NCT01016873|EG001|Reported Event|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993020|NCT01016873|EG002|Reported Event|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
10993021|NCT01016912|BG000|Baseline|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993022|NCT01016912|BG001|Baseline|Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
11007438|NCT01090752|FG001|Participant Flow|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
10993023|NCT01016912|BG002|Baseline|Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993024|NCT01016912|BG003|Baseline|Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
10993025|NCT01016912|BG004|Baseline|Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
10993026|NCT01016912|BG005|Baseline|Total|Total of all reporting groups
10993027|NCT01016912|FG000|Participant Flow|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993028|NCT01016912|FG001|Participant Flow|Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993029|NCT01016912|FG002|Participant Flow|Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993030|NCT01016912|FG003|Participant Flow|Daclatasvir 10- mg + pegIFNα+ Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
10993031|NCT01016912|FG004|Participant Flow|Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
10993032|NCT01016912|OG000|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993033|NCT01016912|OG001|Outcome|Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993034|NCT01016912|OG002|Outcome|Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
10993035|NCT01016912|OG003|Outcome|Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
10993036|NCT01016912|OG004|Outcome|Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
10993037|NCT01016912|OG000|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
10993038|NCT01016912|OG001|Outcome|Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
10993039|NCT01016912|OG002|Outcome|Daclatasvir 60- mg + pegIFNα- + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993040|NCT01016912|OG003|Outcome|Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
10993041|NCT01016912|OG004|Outcome|Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
10993042|NCT01016912|OG000|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993043|NCT01016912|OG001|Outcome|Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
10993044|NCT01016912|OG002|Outcome|Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993045|NCT01016912|OG003|Outcome|Daclatasvir 10- mg + pegINFα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
10993046|NCT01016912|OG004|Outcome|Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
10993047|NCT01016912|OG000|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
10993048|NCT01016912|OG001|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993049|NCT01016912|OG002|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993050|NCT01016912|OG003|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin..
10993051|NCT01016912|OG004|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
10993052|NCT01016912|OG003|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
10993053|NCT01016912|OG003|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
10993054|NCT01016912|OG004|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin
10993055|NCT01016912|OG001|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
10993056|NCT01016912|OG002|Outcome|Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive)|received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
10993057|NCT01016912|EG000|Reported Event|Placebo+pegIFNα +Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin.
10993058|NCT01016912|EG001|Reported Event|Daclatasvir 10- mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
10993059|NCT01016912|EG002|Reported Event|Daclatasvir 60- mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
11007439|NCT01090752|OG000|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
10993060|NCT01016912|EG003|Reported Event|Daclatasvir 10- mg+pegIFNα+Ribavirin (Non--Responders)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
10993061|NCT01016912|EG004|Reported Event|Daclatasvir 60- mg+pegIFNα+Ribavirin (Non--Responders)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
10993062|NCT01016938|BG000|Baseline|Dynmaic Lung MRI|Lung Tumor Motion and Function
10993063|NCT01016938|FG000|Participant Flow|Dynamic Lung MRI|Lung Tumor Motion and Function
10993064|NCT01016938|OG000|Outcome|Lung Tumor Motion and Lung Function|This is a pilot study and there is only one group.
10993065|NCT01016938|OG000|Outcome|Dynamic Lung MRI|Lung Tumor Motion and Function
10993066|NCT01016938|EG000|Reported Event|Dynamic Lung MRI|Lung Tumor Motion and Function
10993067|NCT01016964|BG000|Baseline|Sham Device|Sham device
10993068|NCT01016964|BG001|Baseline|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
10993069|NCT01016964|BG002|Baseline|Total|Total of all reporting groups
10993070|NCT01016964|FG000|Participant Flow|Sham Device|Sham device
10993071|NCT01016964|FG001|Participant Flow|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
10993072|NCT01016964|OG000|Outcome|Sham Device|This control device emits white light
10993073|NCT01016964|OG001|Outcome|LLT Device 2009 12 Beams|This is the active LLLT device
10993074|NCT01016964|EG000|Reported Event|Sham Device|Sham device
10993075|NCT01016964|EG001|Reported Event|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
10993076|NCT01016977|BG000|Baseline|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
10993077|NCT01016977|BG001|Baseline|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
10993078|NCT01016977|BG002|Baseline|Total|Total of all reporting groups
10993079|NCT01016977|FG000|Participant Flow|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
10993080|NCT01016977|FG001|Participant Flow|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
10993081|NCT01016977|OG000|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
10993082|NCT01016977|OG001|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
10993083|NCT01016977|OG000|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
10993084|NCT01016977|OG001|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
10993085|NCT01016977|OG001|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
10993086|NCT01016977|EG000|Reported Event|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
10993087|NCT01016977|EG001|Reported Event|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
10993088|NCT01017003|BG000|Baseline|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
10993089|NCT01017003|FG000|Participant Flow|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
10993090|NCT01017003|OG000|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
10993091|NCT01017003|OG001|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
10993092|NCT01017003|EG000|Reported Event|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
10993093|NCT01017003|EG001|Reported Event|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
10993094|NCT01017029|BG000|Baseline|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
10993095|NCT01017029|BG001|Baseline|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
10993096|NCT01017029|BG002|Baseline|Total|Total of all reporting groups
10993097|NCT01017029|FG000|Participant Flow|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
11007440|NCT01090752|OG001|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
10993098|NCT01017029|FG001|Participant Flow|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
10993099|NCT01017029|OG000|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
10993100|NCT01017029|OG001|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
10993101|NCT01017029|EG000|Reported Event|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
10993102|NCT01017029|EG001|Reported Event|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
10993103|NCT01017042|BG000|Baseline|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
10993104|NCT01017042|FG000|Participant Flow|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
10993105|NCT01017042|OG000|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
10993106|NCT01017042|OG000|Outcome|Corrected QTc Interval (Baseline)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (Baseline)
10993107|NCT01017042|OG001|Outcome|Corrected QTc Interval (0.5 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (0.5hour)
10993108|NCT01017042|OG002|Outcome|Corrected QTc Interval (1 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (1 hour)
10993109|NCT01017042|OG003|Outcome|Corrected QTc Interval (2 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (2 hour)
10993110|NCT01017042|OG004|Outcome|Corrected QTc Interval (4 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (4 hour)
10993111|NCT01017042|EG000|Reported Event|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
10993112|NCT01017120|BG000|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993113|NCT01017120|BG001|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993114|NCT01017120|BG002|Baseline|Total|Total of all reporting groups
10993115|NCT01017120|FG000|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993116|NCT01017120|FG001|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993117|NCT01017120|OG000|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993118|NCT01017120|OG001|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993119|NCT01017120|EG000|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
11007441|NCT01090752|EG000|Reported Event|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
11099015|NCT01579214|BG000|Baseline|Pre-Intervention Control Group|Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation.
11223249|NCT02352493|BG002|Baseline|ALN-CC5 50mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 50mg
11223250|NCT02352493|BG003|Baseline|ALN-CC5 200mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 200mg
10876538|NCT00442936|BG003|Baseline|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
10876539|NCT00442936|BG004|Baseline|Total|Total of all reporting groups
10876540|NCT00442936|FG000|Participant Flow|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
10876541|NCT00442936|FG001|Participant Flow|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
10876542|NCT00442936|FG002|Participant Flow|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
10876543|NCT00442936|FG003|Participant Flow|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
10876544|NCT00442936|OG000|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
10876545|NCT00442936|OG001|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
10876546|NCT00442936|OG002|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
10876547|NCT00442936|OG003|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
10876548|NCT00442936|EG000|Reported Event|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
10876549|NCT00442936|EG001|Reported Event|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
10876550|NCT00442936|EG002|Reported Event|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
10876551|NCT00442936|EG003|Reported Event|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
10876552|NCT00442962|BG000|Baseline|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
10876553|NCT00442962|FG000|Participant Flow|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
10876554|NCT00442962|OG000|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
10876555|NCT00442962|EG000|Reported Event|EFV+FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
11223251|NCT02352493|BG004|Baseline|ALN-CC5 200mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 200mg
10876556|NCT00443053|BG000|Baseline|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
10876557|NCT00443053|BG001|Baseline|Placebo|Matching placebo
10876558|NCT00443053|BG002|Baseline|Total|Total of all reporting groups
10876559|NCT00443053|FG000|Participant Flow|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
10876560|NCT00443053|FG001|Participant Flow|Placebo|Matching placebo
10876561|NCT00443053|OG000|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
10876562|NCT00443053|OG001|Outcome|Placebo|Matching placebo
10876563|NCT00443053|EG000|Reported Event|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
10876564|NCT00443053|EG001|Reported Event|Placebo|Matching placebo
10876565|NCT00443079|BG000|Baseline|Siliphos/Placebo|Subjects treated with Siliphos (1 pill by mouth three times daily) for 6 weeks with 2 weeks of washout followed by placebo (1 pill by mouth three times daily) for 6 weeks
10876566|NCT00443079|BG001|Baseline|Placebo/Siliphos|Subjects treated with Placebo (1 pill by mouth three times daily) for 6 weeks with 2 weeks of washout followed by Siliphos (1 pill by mouth three times daily) for 6 weeks
10876567|NCT00443079|BG002|Baseline|Total|Total of all reporting groups
10876568|NCT00443079|FG000|Participant Flow|Siliphos/Placebo|Subjects treated with study drug (IdB 1016 1 pill by mouth 3 times daily) for 6 weeks with 2 weeks of washout followed by placebo 1 pill by mouth three times daily for 6 weeks
10876569|NCT00443079|FG001|Participant Flow|Placebo/Siliphos|Subjects treated with placebo 1 pill by mouth three times daily for 6 weeks with 2 weeks of washout followed by study drug (IdB 1016 1 pill by mouth 3 times daily) for 6 weeks
10876570|NCT00443079|OG000|Outcome|Siliphos|"All participants received both study drug and placebo. Adverse events were evaluated for all participants during the time period that they were receiving Siliphos.~IdB 1016 (Siliphos): 1 pill 3 times daily x 6 weeks"
10876571|NCT00443079|OG001|Outcome|Placebo|"Adverse events were evaluated for all participants during the time period that they received placebo.~Placebo: 1 pill 3 times daily x 6 weeks"
10876572|NCT00443079|OG000|Outcome|Siliphos|"Entire study population receiving 1 or more doses of study drug. Comparison of ALT measured at the beginning and end of treatment period during the time that Siliphos was administered.~Siliphos 1 pill by mouth three times daily x 6 weeks"
10876573|NCT00443079|OG001|Outcome|Placebo|"Entire study population receiving 1 or more doses of study drug. Comparison of ALT measured at the beginning and end of treatment period during the time that placebo was administered.~Placebo 1 pill by mouth three times daily x 6 weeks"
10876574|NCT00443079|EG000|Reported Event|Siliphos|Siliphos 1 pill by mouth three times daily for 6 weeks (combined for all participants)
10876575|NCT00443079|EG001|Reported Event|Placebo|Placebo 1 pill by mouth three times daily for 6 weeks (combined for all participants)
10876576|NCT00443118|BG000|Baseline|T-Piece|Subjects assigned to be resuscitated with T-Piece
10876577|NCT00443118|BG001|Baseline|Self Inflating Bag With PEEP|Subjects allocated to Self Inflating Bag with PEEP
10876578|NCT00443118|BG002|Baseline|Self Inflating Bag Without PEEP|Subjects allocated to Self Inflating Bag without PEEP
10876579|NCT00443118|BG003|Baseline|Total|Total of all reporting groups
10876580|NCT00443118|FG000|Participant Flow|T-Piece|Subjects assigned to be resuscitated with T-Piece
10876581|NCT00443118|FG001|Participant Flow|SIB - With PEEP Valve|Subjects allocated to SIB with a PEEP valve attached
10876582|NCT00443118|FG002|Participant Flow|SIB-Without PEEP Valve|Self inflating bag without PEEP valve
10876583|NCT00443118|OG000|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
10876584|NCT00443118|OG001|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve attached
10876585|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve attached
10876586|NCT00443118|OG001|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
10876587|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag withouth a PEEP valve
10876588|NCT00443118|OG001|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to be ventilated using a Self Inlfating Bag with PEEP valve
10876589|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Sujects allocated to be ventilated with Self Inflating Bag Without PEEP valve
10876590|NCT00443118|OG001|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with a PEEP valve attached
10876591|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag without PEEP valve
10876592|NCT00443118|OG001|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
10876593|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Subjects Allocated to SIB without PEEP valve
10876594|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag Without PEEP valve
10876595|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Self Inflating Bag without PEEP valve
10876596|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
10876597|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
10876598|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|subjects allocate to SIB Without PEEP valve
10876599|NCT00443118|OG001|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Without PEEP valve
10876600|NCT00443118|OG002|Outcome|SIB-Without PEEP Valve|Subjects allocated to be resuscitated with Self Inflating Bag Without PEEP valve
10876601|NCT00443118|OG000|Outcome|Neopuff TM With PEEP|"Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP~T-piece resuscitator Neopuff TM: Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol."
11223252|NCT02352493|BG005|Baseline|ALN-CC5 400mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 400mg
11099016|NCT01579214|BG001|Baseline|Intervention Period|"Participants in the intervention period (September 2012 - November 2013) were receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading ABCDEFG to confidentially convey an abnormal result.~For our a priori hypothesis, we aimed to test whether clinical outcomes, i.e. time to clinic return and time to ART initiation, were different in the pre-intervention and intervention period. This was a non-randomized allocation.~During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention."
11099017|NCT01579214|BG002|Baseline|Total|Total of all reporting groups
11099018|NCT01579214|FG000|Participant Flow|Pre-Intervention Control Group|Participants followed prior to SMS intervention as a negative control group.
11099019|NCT01579214|FG001|Participant Flow|Intervention Group|Received a text message stating laboratory results were abnormal and requesting return to clinic.
11099020|NCT01579214|OG000|Outcome|Pre-Intervention Control Group|Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation.
11099021|NCT01579214|OG001|Outcome|Intervention Period|"Participants in the intervention period (September 2012 - November 2013) were receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading ABCDEFG to confidentially convey an abnormal result.~For our a priori hypothesis, we aimed to test whether clinical outcomes, i.e. time to clinic return and time to ART initiation, were different in the pre-intervention and intervention period. This was a non-randomized allocation.~During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention."
11099022|NCT01579214|EG000|Reported Event|Pre-Intervention Control Group|Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation.
11099023|NCT01579214|EG001|Reported Event|Intervention Period|"Participants in the intervention period (September 2012 - November 2013) were randomized to receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading ABCDEFG to confidentially convey an abnormal result.~During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention."
11099024|NCT01579305|BG000|Baseline|Subjects Randomized to Receive VOLBELLA®|
11348226|NCT04195880|FG000|Participant Flow|Experimental VA Community Living Centers|"Eight VA CLCs selected to receive the INTERACT intervention~Interventions to Reduce Acute Care Transfers: Experimental CLCs were trained in INTERACT QI Intervention, containing tools, strategies and educational resources designed to catch and manage acute changes in conditions early that a Veteran may be experiencing, leading to a potential reduction in preventable hospital transfers from CLCs."
10876602|NCT00443118|OG001|Outcome|Self Inflating Bag With PEEP|"Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached~Self Inflating Bag with PEEP: Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol."
10876603|NCT00443118|OG002|Outcome|Self Inflating Bag Without PEEP|"Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached~Self Inflating Bag without PEEP: Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol."
10876604|NCT00443118|EG000|Reported Event|T-Piece|Subjects assigned to be resuscitated with T-Piece
10876605|NCT00443118|EG001|Reported Event|SIB - Self Inflating Bag With PEEP|Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve
10876606|NCT00443118|EG002|Reported Event|SIB Without PEEP|Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve
10876607|NCT00443209|BG000|Baseline|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
10876608|NCT00443209|BG001|Baseline|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
10876609|NCT00443209|BG002|Baseline|Total|Total of all reporting groups
11099025|NCT01579305|BG001|Baseline|Subjects Randomized to Receive Restylane-L®|
10876610|NCT00443209|FG000|Participant Flow|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
10876611|NCT00443209|FG001|Participant Flow|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
10876612|NCT00443209|OG000|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
10876613|NCT00443209|OG001|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
10876614|NCT00443209|EG000|Reported Event|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
11007442|NCT01090752|EG001|Reported Event|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
11007443|NCT01090765|BG000|Baseline|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
11007444|NCT01090765|BG001|Baseline|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
11007445|NCT01090765|BG002|Baseline|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
11007446|NCT01090765|BG003|Baseline|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
11007447|NCT01090765|BG004|Baseline|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
11007448|NCT01090765|BG005|Baseline|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
11007449|NCT01090765|BG006|Baseline|Total|Total of all reporting groups
11007450|NCT01090765|FG000|Participant Flow|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
11007451|NCT01090765|FG001|Participant Flow|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
11007452|NCT01090765|FG002|Participant Flow|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
11007453|NCT01090765|FG003|Participant Flow|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
11007454|NCT01090765|FG004|Participant Flow|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
11007455|NCT01090765|FG005|Participant Flow|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
11007456|NCT01090765|OG000|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
11007457|NCT01090765|OG000|Outcome|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
11007458|NCT01090765|OG001|Outcome|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
11007459|NCT01090765|OG002|Outcome|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
11007460|NCT01090765|OG003|Outcome|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
11007461|NCT01090765|OG004|Outcome|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
11007462|NCT01090765|OG005|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
11007463|NCT01090765|EG000|Reported Event|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
11007464|NCT01090765|EG001|Reported Event|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
11007465|NCT01090765|EG002|Reported Event|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
11007466|NCT01090765|EG003|Reported Event|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
11007467|NCT01090765|EG004|Reported Event|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
11007468|NCT01090765|EG005|Reported Event|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
11007469|NCT01090921|BG000|Baseline|Bortezomib and Dexamethasone|"Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.~Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.~Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone."
10993120|NCT01017120|EG001|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993121|NCT01017146|BG000|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993122|NCT01017146|BG001|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993123|NCT01017146|BG002|Baseline|Total|Total of all reporting groups
10993124|NCT01017146|FG000|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993125|NCT01017146|FG001|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993126|NCT01017146|OG000|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993127|NCT01017146|OG001|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993128|NCT01017146|EG000|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993129|NCT01017146|EG001|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
10993130|NCT01017237|BG000|Baseline|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
10993131|NCT01017237|BG001|Baseline|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
10993132|NCT01017237|BG002|Baseline|Total|Total of all reporting groups
10993133|NCT01017237|FG000|Participant Flow|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
10993134|NCT01017237|FG001|Participant Flow|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
10993135|NCT01017237|OG000|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
11099026|NCT01579305|BG002|Baseline|Total|Total of all reporting groups
11099027|NCT01579305|FG000|Participant Flow|Subject Randomized to Receive VOLBELLA®|
11099028|NCT01579305|FG001|Participant Flow|Subjects Randomized to Receive Restylane-L®|
11099029|NCT01579305|OG000|Outcome|Subjects Randomized to Receive VOLBELLA® and Treated|
11099030|NCT01579305|OG001|Outcome|Subjects Randomized to Receive Restylane-L® and Treated|
10876615|NCT00443209|EG001|Reported Event|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
10876616|NCT00443261|BG000|Baseline|1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days"
10876617|NCT00443261|FG000|Participant Flow|Arm 1: SCCHN|"Intervention:~Azacitidine: SC daily X 5 every 28 days azacitidine at assigned dose ranging from 37 to 110 mg/M^2/day.~Cisplatin: cisplatin 75 mg/m^2 day 8 every 28 days"
10876618|NCT00443261|OG000|Outcome|Arm 1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m^2 day 8 every 28 days"
10876619|NCT00443261|EG000|Reported Event|1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days"
10876620|NCT00443352|BG000|Baseline|Duloxetine Completers|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
10876621|NCT00443352|FG000|Participant Flow|Duloxetine|Duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
10876622|NCT00443352|OG000|Outcome|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
10876623|NCT00443352|EG000|Reported Event|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
10876624|NCT00443430|BG000|Baseline|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
10876625|NCT00443430|BG001|Baseline|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
10876626|NCT00443430|BG002|Baseline|Total|Total of all reporting groups
10876627|NCT00443430|FG000|Participant Flow|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
10876628|NCT00443430|FG001|Participant Flow|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
10876629|NCT00443430|OG000|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
10876630|NCT00443430|OG001|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
10876631|NCT00443430|EG000|Reported Event|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
10876632|NCT00443430|EG001|Reported Event|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
10876633|NCT00443456|BG000|Baseline|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
10876634|NCT00443456|FG000|Participant Flow|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
10876635|NCT00443456|OG000|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
10876636|NCT00443456|OG001|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
10876637|NCT00443456|OG002|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
10876638|NCT00443456|OG000|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
10876639|NCT00443456|OG001|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
10876640|NCT00443456|EG000|Reported Event|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study
10876641|NCT00443534|BG000|Baseline|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
10876642|NCT00443534|FG000|Participant Flow|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
10876643|NCT00443534|OG000|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
11099031|NCT01579305|EG000|Reported Event|Subjects Treated With VOLBELLA®|
11099032|NCT01579305|EG001|Reported Event|Subjects Treated With Restylane-L®|
11223253|NCT02352493|BG006|Baseline|ALN-CC5 600mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 600mg
10993136|NCT01017237|OG001|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
10993137|NCT01017237|OG000|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
10993138|NCT01017237|OG001|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
10993139|NCT01017237|OG000|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
10993140|NCT01017237|EG000|Reported Event|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
10993141|NCT01017237|EG001|Reported Event|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
10993142|NCT01017250|BG000|Baseline|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
10993143|NCT01017250|FG000|Participant Flow|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
10993144|NCT01017250|OG000|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
10993145|NCT01017250|OG000|Outcome|Stereotactic Radiosurgery|Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
10993146|NCT01017250|EG000|Reported Event|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
10993147|NCT01017497|BG000|Baseline|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
10993148|NCT01017497|FG000|Participant Flow|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
10993149|NCT01017497|OG000|Outcome|1mm Margin|"GTV expanded by 1 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
10993150|NCT01017497|OG001|Outcome|3mm Margin|"GTV expanded by 3 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
10993151|NCT01017497|OG000|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
10993152|NCT01017497|EG000|Reported Event|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
10993153|NCT01017536|BG000|Baseline|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
10993154|NCT01017536|BG001|Baseline|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
10993155|NCT01017536|BG002|Baseline|Total|Total of all reporting groups
10993156|NCT01017536|FG000|Participant Flow|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
10993157|NCT01017536|FG001|Participant Flow|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
10993158|NCT01017536|OG000|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
10993159|NCT01017536|OG001|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
10993160|NCT01017536|EG000|Reported Event|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
10993161|NCT01017536|EG001|Reported Event|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
10993162|NCT01017549|BG000|Baseline|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
10993163|NCT01017549|FG000|Participant Flow|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
10993164|NCT01017549|OG000|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
10993165|NCT01017549|EG000|Reported Event|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
10993166|NCT01017575|BG000|Baseline|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
10993167|NCT01017575|BG001|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
10993168|NCT01017575|BG002|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
10993169|NCT01017575|BG003|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
10993170|NCT01017575|BG004|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
10993171|NCT01017575|BG005|Baseline|Total|Total of all reporting groups
10993172|NCT01017575|FG000|Participant Flow|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
10993173|NCT01017575|FG001|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
10993174|NCT01017575|FG002|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
10993175|NCT01017575|FG003|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
10993176|NCT01017575|FG004|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
10993177|NCT01017575|OG000|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
10993178|NCT01017575|OG001|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
10993179|NCT01017575|OG002|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
10993180|NCT01017575|OG003|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
10993181|NCT01017575|OG004|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
10876644|NCT00443534|EG000|Reported Event|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
10876645|NCT00443547|BG000|Baseline|1-level|Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876646|NCT00443547|BG001|Baseline|2-level|Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876647|NCT00443547|BG002|Baseline|3-level|Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876648|NCT00443547|BG003|Baseline|4-level|Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876649|NCT00443547|BG004|Baseline|Total|Total of all reporting groups
10876650|NCT00443547|FG000|Participant Flow|1-level|Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876651|NCT00443547|FG001|Participant Flow|2-level|Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876652|NCT00443547|FG002|Participant Flow|3-level|Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876653|NCT00443547|FG003|Participant Flow|4-level|Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876654|NCT00443547|OG000|Outcome|1-level|Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876655|NCT00443547|OG001|Outcome|2-level|Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876656|NCT00443547|OG002|Outcome|3-level|Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876657|NCT00443547|OG003|Outcome|4-level|Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876658|NCT00443547|EG000|Reported Event|1-level|Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876659|NCT00443547|EG001|Reported Event|2-level|Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876660|NCT00443547|EG002|Reported Event|3-level|Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876661|NCT00443547|EG003|Reported Event|4-level|Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
10876662|NCT00443560|BG000|Baseline|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
10876663|NCT00443560|BG001|Baseline|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
10876664|NCT00443560|BG002|Baseline|Total|Total of all reporting groups
10876665|NCT00443560|FG000|Participant Flow|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
10876666|NCT00443560|FG001|Participant Flow|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
10876667|NCT00443560|OG000|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
10876668|NCT00443560|OG001|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
10876669|NCT00443560|EG000|Reported Event|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
10876670|NCT00443560|EG001|Reported Event|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
10876671|NCT00443599|BG000|Baseline|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
10876672|NCT00443599|BG001|Baseline|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
10876673|NCT00443599|BG002|Baseline|Total|Total of all reporting groups
10876674|NCT00443599|FG000|Participant Flow|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
10876675|NCT00443599|FG001|Participant Flow|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
11223254|NCT02352493|BG007|Baseline|ALN-CC5 600mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 600mg
10993182|NCT01017575|EG000|Reported Event|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
10993183|NCT01017575|EG001|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
10993184|NCT01017575|EG002|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
10993185|NCT01017575|EG003|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
10993186|NCT01017575|EG004|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
10993187|NCT01017601|BG000|Baseline|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
10993188|NCT01017601|BG001|Baseline|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
10993189|NCT01017601|BG002|Baseline|Total|Total of all reporting groups
10993190|NCT01017601|FG000|Participant Flow|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
10993191|NCT01017601|FG001|Participant Flow|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
10993192|NCT01017601|OG000|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
10993193|NCT01017601|OG001|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
10993194|NCT01017601|EG000|Reported Event|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
10993195|NCT01017601|EG001|Reported Event|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
10993196|NCT01017653|BG000|Baseline|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
10993197|NCT01017653|FG000|Participant Flow|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
10993198|NCT01017653|OG000|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
10993199|NCT01017653|EG000|Reported Event|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
10993200|NCT01017731|BG000|Baseline|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
10993201|NCT01017731|FG000|Participant Flow|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
11223255|NCT02352493|BG008|Baseline|ALN-CC5 900mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 900mg
10993202|NCT01017731|OG000|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
10993203|NCT01017731|OG000|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously over 1 hour, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: 25 to 50 milligrams (mg) administered intravenously 1 day before each administration of ramucirumab for Cycles 1 to 4. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
10993204|NCT01017731|EG000|Reported Event|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
10993205|NCT01017874|BG000|Baseline|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
10993206|NCT01017874|BG001|Baseline|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
10993207|NCT01017874|BG002|Baseline|Total|Total of all reporting groups
10993208|NCT01017874|FG000|Participant Flow|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
10993209|NCT01017874|FG001|Participant Flow|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
10993210|NCT01017874|OG000|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
10993211|NCT01017874|OG001|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
10993212|NCT01017874|EG000|Reported Event|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
10993213|NCT01017874|EG001|Reported Event|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
10993214|NCT01017952|BG000|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993215|NCT01017952|BG001|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993216|NCT01017952|BG002|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993217|NCT01017952|BG003|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993218|NCT01017952|BG004|Baseline|Total|Total of all reporting groups
10993219|NCT01017952|FG000|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
11223256|NCT02352493|BG009|Baseline|Placebo - Multiple Ascending Dose|Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
10876676|NCT00443599|OG000|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
10876677|NCT00443599|OG001|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
10876678|NCT00443599|EG000|Reported Event|Insulin|Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
10876679|NCT00443599|EG001|Reported Event|Usual Care|Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control.
10876680|NCT00443651|BG000|Baseline|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
10876681|NCT00443651|BG001|Baseline|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
10876682|NCT00443651|BG002|Baseline|Total|Total of all reporting groups
10876683|NCT00443651|FG000|Participant Flow|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
10876684|NCT00443651|FG001|Participant Flow|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
10876685|NCT00443651|OG000|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
10876686|NCT00443651|OG001|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
10876687|NCT00443651|EG000|Reported Event|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
10876688|NCT00443651|EG001|Reported Event|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
10876689|NCT00443703|BG000|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876690|NCT00443703|BG001|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876691|NCT00443703|BG002|Baseline|Total|Total of all reporting groups
10876692|NCT00443703|FG000|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
11223257|NCT02352493|BG010|Baseline|ALN-CC5 100mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
10993220|NCT01017952|FG001|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993221|NCT01017952|FG002|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993222|NCT01017952|FG003|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993223|NCT01017952|FG004|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993224|NCT01017952|OG000|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993225|NCT01017952|OG001|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993226|NCT01017952|OG002|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993227|NCT01017952|OG003|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993228|NCT01017952|EG000|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993229|NCT01017952|EG001|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993230|NCT01017952|EG002|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993231|NCT01017952|EG003|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
10993232|NCT01018030|BG000|Baseline|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
10993233|NCT01018030|BG001|Baseline|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
10993234|NCT01018030|BG002|Baseline|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
10993235|NCT01018030|BG003|Baseline|Total|Total of all reporting groups
10993236|NCT01018030|FG000|Participant Flow|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
10993237|NCT01018030|FG001|Participant Flow|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
10993238|NCT01018030|FG002|Participant Flow|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
10993239|NCT01018030|OG000|Outcome|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
10993240|NCT01018030|OG001|Outcome|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
10993241|NCT01018030|OG002|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
10993242|NCT01018030|OG000|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
10993243|NCT01018030|OG001|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
10993244|NCT01018030|EG000|Reported Event|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
10993245|NCT01018030|EG001|Reported Event|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
10993246|NCT01018030|EG002|Reported Event|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
11223258|NCT02352493|BG011|Baseline|ALN-CC5 200mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
11223259|NCT02352493|BG012|Baseline|ALN-CC5 400mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
11223260|NCT02352493|BG013|Baseline|ALN-CC5 600mg Biweekly - Multiple Ascending Dose|Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
11223261|NCT02352493|BG014|Baseline|ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
11223262|NCT02352493|BG015|Baseline|ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
10993247|NCT01018056|BG000|Baseline|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment."
10993248|NCT01018056|BG001|Baseline|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
10993249|NCT01018056|BG002|Baseline|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
10993250|NCT01018056|BG003|Baseline|Total|Total of all reporting groups
10993251|NCT01018056|FG000|Participant Flow|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment."
10993252|NCT01018056|FG001|Participant Flow|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
10993253|NCT01018056|FG002|Participant Flow|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
10993254|NCT01018056|OG000|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment."
10993255|NCT01018056|OG001|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
11099033|NCT01579318|BG000|Baseline|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
10993256|NCT01018056|OG002|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
10993257|NCT01018056|OG002|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4."
10993258|NCT01018056|OG002|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3."
10993259|NCT01018056|OG002|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4."
10993260|NCT01018056|EG000|Reported Event|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment."
10993261|NCT01018056|EG001|Reported Event|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
10993262|NCT01018056|EG002|Reported Event|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
10993263|NCT01018095|BG000|Baseline|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
10993264|NCT01018095|BG001|Baseline|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
10993265|NCT01018095|BG002|Baseline|Total|Total of all reporting groups
10993266|NCT01018095|FG000|Participant Flow|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
10993267|NCT01018095|FG001|Participant Flow|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
10993268|NCT01018095|OG000|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
10993269|NCT01018095|OG001|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
10993270|NCT01018095|EG000|Reported Event|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
10993271|NCT01018095|EG001|Reported Event|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
10993272|NCT01018134|BG000|Baseline|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
10993273|NCT01018134|BG001|Baseline|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
10993274|NCT01018134|BG002|Baseline|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
10993275|NCT01018134|BG003|Baseline|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
10993276|NCT01018134|BG004|Baseline|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
10993277|NCT01018134|BG005|Baseline|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
10993278|NCT01018134|BG006|Baseline|Total|Total of all reporting groups
10993279|NCT01018134|FG000|Participant Flow|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
10993280|NCT01018134|FG001|Participant Flow|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
10993281|NCT01018134|FG002|Participant Flow|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
10993282|NCT01018134|FG003|Participant Flow|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
10993283|NCT01018134|FG004|Participant Flow|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
10993284|NCT01018134|FG005|Participant Flow|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
10993285|NCT01018134|OG000|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
10993286|NCT01018134|OG001|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
10993287|NCT01018134|OG002|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
10993288|NCT01018134|OG003|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
10993289|NCT01018134|OG004|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
10993290|NCT01018134|OG005|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
10993291|NCT01018134|EG000|Reported Event|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
10993292|NCT01018134|EG001|Reported Event|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
10993293|NCT01018134|EG002|Reported Event|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
10993294|NCT01018134|EG003|Reported Event|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
10993295|NCT01018134|EG004|Reported Event|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
10993296|NCT01018134|EG005|Reported Event|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
10993297|NCT01018186|BG000|Baseline|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993298|NCT01018186|BG001|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993299|NCT01018186|BG002|Baseline|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993300|NCT01018186|BG003|Baseline|Total|Total of all reporting groups
10993301|NCT01018186|FG000|Participant Flow|Current Asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) with or without an additional controller medication (i.e., long-acting beta-agonist, leukotriene modifier, etc.) for 2 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
10993302|NCT01018186|FG001|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11223263|NCT02352493|BG016|Baseline|ALN-CC5 Multiple Dose - Eculizumab Treated|Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
10993303|NCT01018186|FG002|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993304|NCT01018186|FG003|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993305|NCT01018186|OG000|Outcome|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993306|NCT01018186|OG001|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993307|NCT01018186|OG002|Outcome|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993308|NCT01018186|OG000|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993309|NCT01018186|OG002|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993310|NCT01018186|OG001|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participnts were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993311|NCT01018186|OG002|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albutero/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993312|NCT01018186|EG000|Reported Event|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993313|NCT01018186|EG001|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993314|NCT01018186|EG002|Reported Event|FP 500 µg BD|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10993315|NCT01018264|BG000|Baseline|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
10993316|NCT01018264|BG001|Baseline|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
10993317|NCT01018264|BG002|Baseline|Total|Total of all reporting groups
10993318|NCT01018264|FG000|Participant Flow|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
10993319|NCT01018264|FG001|Participant Flow|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
10993320|NCT01018264|OG000|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
10993321|NCT01018264|OG001|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
10993322|NCT01018264|EG000|Reported Event|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
10993323|NCT01018264|EG001|Reported Event|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
10993324|NCT01018394|BG000|Baseline|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
10993325|NCT01018394|BG001|Baseline|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
10993326|NCT01018394|BG002|Baseline|Total|Total of all reporting groups
10993327|NCT01018394|FG000|Participant Flow|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
10993328|NCT01018394|FG001|Participant Flow|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
10993329|NCT01018394|OG000|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
10993330|NCT01018394|OG001|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
10876693|NCT00443703|FG001|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876694|NCT00443703|OG000|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876695|NCT00443703|OG001|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876696|NCT00443703|EG000|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876697|NCT00443703|EG001|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876698|NCT00443729|BG000|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876699|NCT00443729|BG001|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876700|NCT00443729|BG002|Baseline|Total|Total of all reporting groups
10876701|NCT00443729|FG000|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876702|NCT00443729|FG001|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876703|NCT00443729|OG000|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876704|NCT00443729|OG001|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876705|NCT00443729|EG000|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876706|NCT00443729|EG001|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
10876707|NCT00443755|BG000|Baseline|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
10876708|NCT00443755|BG001|Baseline|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
10876709|NCT00443755|BG002|Baseline|Total|Total of all reporting groups
10876710|NCT00443755|FG000|Participant Flow|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
10876711|NCT00443755|FG001|Participant Flow|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
10876712|NCT00443755|OG000|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
10876713|NCT00443755|OG001|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
10876714|NCT00443755|EG000|Reported Event|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
10876715|NCT00443755|EG001|Reported Event|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
10876716|NCT00443781|BG000|Baseline|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
10876717|NCT00443781|FG000|Participant Flow|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
10876718|NCT00443781|OG000|Outcome|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
10876719|NCT00443781|EG000|Reported Event|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
10876720|NCT00443820|BG000|Baseline|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
10876721|NCT00443820|BG001|Baseline|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
10876722|NCT00443820|BG002|Baseline|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
10876723|NCT00443820|BG003|Baseline|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
10876724|NCT00443820|BG004|Baseline|Total|Total of all reporting groups
10876725|NCT00443820|FG000|Participant Flow|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
10876726|NCT00443820|FG001|Participant Flow|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
10876727|NCT00443820|FG002|Participant Flow|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
10876728|NCT00443820|FG003|Participant Flow|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
10876729|NCT00443820|OG000|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
10876730|NCT00443820|OG001|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
10876731|NCT00443820|OG002|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
10876732|NCT00443820|OG003|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
10876733|NCT00443820|EG000|Reported Event|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
10876734|NCT00443820|EG001|Reported Event|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
10876735|NCT00443820|EG002|Reported Event|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
10876736|NCT00443820|EG003|Reported Event|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
10876737|NCT00443846|BG000|Baseline|Group 1: Concomitant Administration|Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
10876738|NCT00443846|BG001|Baseline|Group 2: Sequential Administration|Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
10876739|NCT00443846|BG002|Baseline|Total|Total of all reporting groups
10876740|NCT00443846|FG000|Participant Flow|Group 1: Concomitant Administration|Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
10876741|NCT00443846|FG001|Participant Flow|Group 2: Sequential Administration|Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
10876742|NCT00443846|OG000|Outcome|Group 1: Concomitant Administration|Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
10876743|NCT00443846|OG001|Outcome|Group 2: Sequential Administration|Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
10876744|NCT00443846|EG000|Reported Event|Group 1: Concomitant Administration|Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
10876745|NCT00443846|EG001|Reported Event|Group 2: Sequential Administration|Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
10876746|NCT00443872|BG000|Baseline|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
10876747|NCT00443872|FG000|Participant Flow|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
10876748|NCT00443872|OG000|Outcome|PD Patients With DA Related AE|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of either one or more of the following: excessive daytime sleepiness, hallucinations, pedal edema, impulse control disorder, received 1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated.
10876749|NCT00443872|OG000|Outcome|PD Patients With DA Related AE (Daytime Sleepiness)|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of daytime sleepiness received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for the remaining 6 weeks if tolerated.
10876750|NCT00443872|OG000|Outcome|PD Patients With DA Related AE (Hallucinations)|Patients who are experiencing the dopamine agonist (DA) related adverse effect of hallucinations. The participants received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5 mg once daily if tolerated.
10876751|NCT00443872|OG000|Outcome|PD Patiens With DA Related AE (Pedal Edema)|Patients who are experiencing a dopamine agonist (DA) related AE of pedal edema received 1.25mg once daily of orally disintegrating selegiline for 6 weeks after which there was an increase to 2.5 mg once daily if tolerated.
10876752|NCT00443872|OG000|Outcome|PD Patients With DA Related AE (Impulse Control Disorder)|Patients who are experiencing dopamine agonist (DA) related adverse effect (AE) of impulse control disorder (ICD) received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5mg once daily if tolerated.
10876753|NCT00443872|OG000|Outcome|All Subjects With DA Related AEs (UPDRS Data)|For all completed subjects (60) UPDRS activities of daily living scores and motor scores were collected. All patients received 1.25 mg once daily orally disintegrating selegiline for 6 weeks which was increased to 2.5mg once daily at 12 weeks if tolerated.
10876754|NCT00443872|OG000|Outcome|All Subjects PDQ-39|This includes all patients in the study. They all received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks which was increased to 2.5 mg once daily if tolerated.
10876755|NCT00443872|OG000|Outcome|All PD Patients With DA Related AEs (BDI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
10876756|NCT00443872|OG000|Outcome|All PD Patients With DA Related AEs (BAI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
10876757|NCT00443872|OG000|Outcome|All PD Patients With DA Related AEs (MMSE)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
10876758|NCT00443872|EG000|Reported Event|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
10876759|NCT00443898|BG000|Baseline|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
10876760|NCT00443898|BG001|Baseline|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
10876761|NCT00443898|BG002|Baseline|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
10876762|NCT00443898|BG003|Baseline|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
10876763|NCT00443898|BG004|Baseline|Total|Total of all reporting groups
10876764|NCT00443898|FG000|Participant Flow|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
10876765|NCT00443898|FG001|Participant Flow|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
10876766|NCT00443898|FG002|Participant Flow|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
10876767|NCT00443898|FG003|Participant Flow|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
10876768|NCT00443898|OG000|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
10876769|NCT00443898|OG001|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
10876770|NCT00443898|OG002|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
10876771|NCT00443898|OG003|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
10876772|NCT00443898|EG000|Reported Event|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
10876773|NCT00443898|EG001|Reported Event|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
10876774|NCT00443898|EG002|Reported Event|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
10876775|NCT00443898|EG003|Reported Event|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
10876776|NCT00444028|BG000|Baseline|Placebo|Staccato placebo inhalation device(s)
10876777|NCT00444028|BG001|Baseline|Staccato Loxapine 0.625 mg|inhalation of loxapine from a single 0.625 mg device
10876778|NCT00444028|BG002|Baseline|Staccato Loxapine 1.25 mg|inhalation of loxapine from a two 0.625 mg devices
10876779|NCT00444028|BG003|Baseline|Staccato Loxapine 2.5 mg|inhalation of loxapine from a single 2.5 mg device
10876780|NCT00444028|BG004|Baseline|Staccato Loxapine 5 mg|inhalation of loxapine from a single 5 mg device
10876781|NCT00444028|BG005|Baseline|Staccato Loxapine 10 mg|inhalation of loxapine from a two 5 mg devices
10876782|NCT00444028|BG006|Baseline|Total|Total of all reporting groups
10876783|NCT00444028|FG000|Participant Flow|Placebo|Staccato placebo inhalation device(s)
10876784|NCT00444028|FG001|Participant Flow|Staccato Loxapine 0.625 mg|inhalation of loxapine from a single 0.625 mg device
10876785|NCT00444028|FG002|Participant Flow|Staccato Loxapine 1.25 mg|inhalation of loxapine from a two 0.625 mg devices
10876786|NCT00444028|FG003|Participant Flow|Staccato Loxapine 2.5 mg|inhalation of loxapine from a single 2.5 mg device
10876787|NCT00444028|FG004|Participant Flow|Staccato Loxapine 5 mg|inhalation of loxapine from a single 5 mg device
10876788|NCT00444028|FG005|Participant Flow|Staccato Loxapine 10 mg|inhalation of loxapine from a two 5 mg devices
10876789|NCT00444028|OG000|Outcome|Staccato Loxapine 0.625 mg|inhalation of loxapine from a single 0.625 mg device
10876790|NCT00444028|OG001|Outcome|Staccato Loxapine 1.25 mg|inhalation of loxapine from a two 0.625 mg devices
10876791|NCT00444028|OG002|Outcome|Staccato Loxapine 2.5 mg|inhalation of loxapine from a single 2.5 mg device
10876792|NCT00444028|OG003|Outcome|Staccato Loxapine 5 mg|inhalation of loxapine from a single 5 mg device
10876793|NCT00444028|OG004|Outcome|Staccato Loxapine 10 mg|inhalation of loxapine from a two 5 mg devices
10876794|NCT00444028|EG000|Reported Event|Placebo|Staccato placebo inhalation device(s)
10993331|NCT01018394|EG000|Reported Event|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
11348227|NCT04195880|FG001|Participant Flow|Control VA Community Living Centers|Eight CLCs, matched to experiment CLCs, based on size, location to VAMC, and hospitalization rates, did not receive the intervention and continued care as usual
11348228|NCT04195880|OG000|Outcome|Experimental VA Community Living Centers|"Eight VA CLCs selected to receive the INTERACT intervention~Interventions to Reduce Acute Care Transfers: Experimental CLCs were trained in INTERACT QI Intervention, containing tools, strategies and educational resources designed to catch and manage acute changes in conditions early that a Veteran may be experiencing, leading to a potential reduction in preventable hospital transfers from CLCs."
11348229|NCT04195880|OG001|Outcome|Control VA Community Living Centers|Eight CLCs, matched to experiment CLCs, based on size, location to VAMC, and hospitalization rates, did not receive the intervention and continued care as usual
11348230|NCT04195880|EG000|Reported Event|Experimental VA Community Living Centers|"Eight VA CLCs selected to receive the INTERACT intervention~Interventions to Reduce Acute Care Transfers: Experimental CLCs were trained in INTERACT QI Intervention, containing tools, strategies and educational resources designed to catch and manage acute changes in conditions early that a Veteran may be experiencing, leading to a potential reduction in preventable hospital transfers from CLCs."
11348231|NCT04195880|EG001|Reported Event|Control VA Community Living Centers|Eight CLCs, matched to experiment CLCs, based on size, location to VAMC, and hospitalization rates, did not receive the intervention and continued care as usual
10876795|NCT00444028|EG001|Reported Event|Staccato Loxapine 0.625 mg|inhalation of loxapine from a single 0.625 mg device
10876796|NCT00444028|EG002|Reported Event|Staccato Loxapine 1.25 mg|inhalation of loxapine from a two 0.625 mg devices
10876797|NCT00444028|EG003|Reported Event|Staccato Loxapine 2.5 mg|inhalation of loxapine from a single 2.5 mg device
10876798|NCT00444028|EG004|Reported Event|Staccato Loxapine 5 mg|inhalation of loxapine from a single 5 mg device
10876799|NCT00444028|EG005|Reported Event|Staccato Loxapine 10 mg|inhalation of loxapine from a two 5 mg devices
10876800|NCT00444067|BG000|Baseline|Spinal Sealant|DuraSeal Spinal Sealant System
10876801|NCT00444067|BG001|Baseline|Control|Standard of care methods used as an adjunct to sutured dural repair.
10876802|NCT00444067|BG002|Baseline|Total|Total of all reporting groups
10876803|NCT00444067|FG000|Participant Flow|Spinal Sealant|DuraSeal Spinal Sealant System
10876804|NCT00444067|FG001|Participant Flow|Control|Standard of care methods used as an adjunct to sutured dural repair.
10876805|NCT00444067|OG000|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
10876806|NCT00444067|OG001|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
10876807|NCT00444067|EG000|Reported Event|Spinal Sealant|DuraSeal Spinal Sealant System
10876808|NCT00444067|EG001|Reported Event|Control|Standard of care methods used as an adjunct to sutured dural repair.
10876809|NCT00444080|BG000|Baseline|Control Arm|"Subjects undergoing trabeculectomy with the use of Mitomycin C~Trabeculectomy: Standard trabeculectomy procedure~Creation of a fornix or limbal based conjunctival flap in upper quadrants~Creation of a limbal-based scleral flap extending into clear cornea~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~Creation of fistula 1mm x 2mm in size~Iridectomy~Suturing the scleral flap~Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged."
10993332|NCT01018394|EG001|Reported Event|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
10993333|NCT01018420|BG000|Baseline|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
10993334|NCT01018420|BG001|Baseline|Moxifloxacin|400 mg capsule at the 6 hour point
10993335|NCT01018420|BG002|Baseline|Total|Total of all reporting groups
10993336|NCT01018420|FG000|Participant Flow|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
10993337|NCT01018420|FG001|Participant Flow|Moxifloxacin|400 mg capsule at the 6 hour point
10993338|NCT01018420|OG000|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
10993339|NCT01018420|OG000|Outcome|Baseline|measured 0.5 hr prior to initial colchicine dose
10993340|NCT01018420|OG001|Outcome|Hour 1|measured 1 hour after initial colchicine dose
10993341|NCT01018420|OG002|Outcome|Hour 3|measured 3 hours after initial colchicine dose
10993342|NCT01018420|OG003|Outcome|Hour 6|measured 6 hours after initial colchicine dose
10993343|NCT01018420|OG004|Outcome|Hour 7|measured 7 hours after initial colchicine dose
10993344|NCT01018420|OG005|Outcome|Hour 8|measured 8 hours after initial colchicine dose
10993345|NCT01018420|OG006|Outcome|Hour 10|measured 10 hours after initial colchicine dose
10993346|NCT01018420|OG007|Outcome|Hour 12|measured 12 hours after initial colchicine dose
10993347|NCT01018420|OG008|Outcome|Hour 23|measured 23 hours after initial colchicine dose
10993348|NCT01018420|OG000|Outcome|Baseline|measured 0.5 hour prior to moxifloxacin dose
10993349|NCT01018420|OG001|Outcome|Hour 1|measured 1 hour after moxifloxacin dose
10993350|NCT01018420|OG002|Outcome|Hour 3|measured 3 hours after moxifloxacin dose
10993351|NCT01018420|OG003|Outcome|Hour 6|measured 6 hours after moxifloxacin dose
10993352|NCT01018420|OG004|Outcome|Hour 7|measured 7 hours after moxifloxacin dose
10993353|NCT01018420|OG005|Outcome|Hour 8|measured 8 hours after moxifloxacin dose
10993354|NCT01018420|OG006|Outcome|Hour 10|measured 10 hours after moxifloxacin dose
10993355|NCT01018420|OG007|Outcome|Hour 12|measured 12 hours after moxifloxacin dose
10993356|NCT01018420|OG008|Outcome|Hour 23|measured 23 hours after moxifloxacin dose
10993357|NCT01018420|EG000|Reported Event|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
10993358|NCT01018420|EG001|Reported Event|Moxifloxacin|400 mg capsule at the 6 hour point
10993359|NCT01018511|BG000|Baseline|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993360|NCT01018511|BG001|Baseline|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993361|NCT01018511|BG002|Baseline|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993362|NCT01018511|BG003|Baseline|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993363|NCT01018511|BG004|Baseline|Total|Total of all reporting groups
10993364|NCT01018511|FG000|Participant Flow|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993365|NCT01018511|FG001|Participant Flow|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993366|NCT01018511|FG002|Participant Flow|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993367|NCT01018511|FG003|Participant Flow|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993368|NCT01018511|OG000|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993369|NCT01018511|OG001|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993370|NCT01018511|OG002|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993371|NCT01018511|OG003|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993372|NCT01018511|OG003|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993373|NCT01018511|OG000|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993374|NCT01018511|OG001|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993375|NCT01018511|OG002|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993376|NCT01018511|OG000|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993377|NCT01018511|OG001|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993378|NCT01018511|EG000|Reported Event|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993379|NCT01018511|EG001|Reported Event|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993380|NCT01018511|EG002|Reported Event|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993381|NCT01018511|EG003|Reported Event|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
10993382|NCT01018680|BG000|Baseline|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
10993383|NCT01018680|BG001|Baseline|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
10993384|NCT01018680|BG002|Baseline|Total|Total of all reporting groups
10993385|NCT01018680|FG000|Participant Flow|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
10993386|NCT01018680|FG001|Participant Flow|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
10993387|NCT01018680|OG000|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
10993388|NCT01018680|OG001|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
10993389|NCT01018680|EG000|Reported Event|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
10993390|NCT01018680|EG001|Reported Event|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
10993391|NCT01018732|BG000|Baseline|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
10993392|NCT01018732|BG001|Baseline|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
10993393|NCT01018732|BG002|Baseline|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
10993394|NCT01018732|BG003|Baseline|Total|Total of all reporting groups
10993395|NCT01018732|FG000|Participant Flow|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
10993396|NCT01018732|FG001|Participant Flow|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
10993397|NCT01018732|FG002|Participant Flow|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
10993398|NCT01018732|OG000|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
10993399|NCT01018732|OG001|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
10993400|NCT01018732|OG002|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
10993401|NCT01018732|EG000|Reported Event|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
10993402|NCT01018732|EG001|Reported Event|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
10993403|NCT01018732|EG002|Reported Event|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
10993404|NCT01018862|BG000|Baseline|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993405|NCT01018862|BG001|Baseline|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993406|NCT01018862|BG002|Baseline|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993407|NCT01018862|BG003|Baseline|Total|Total of all reporting groups
10993408|NCT01018862|FG000|Participant Flow|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993409|NCT01018862|FG001|Participant Flow|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993410|NCT01018862|FG002|Participant Flow|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993411|NCT01018862|OG000|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993412|NCT01018862|OG001|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993413|NCT01018862|OG002|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993414|NCT01018862|EG000|Reported Event|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993415|NCT01018862|EG001|Reported Event|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993416|NCT01018862|EG002|Reported Event|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
10993417|NCT01018953|BG000|Baseline|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
10993418|NCT01018953|FG000|Participant Flow|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
10993419|NCT01018953|OG000|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
10993420|NCT01018953|OG000|Outcome|BIM 23A760|
10993421|NCT01018953|EG000|Reported Event|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
10993422|NCT01018979|BG000|Baseline|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
10993423|NCT01018979|BG001|Baseline|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
10993424|NCT01018979|BG002|Baseline|Total|Total of all reporting groups
10993425|NCT01018979|FG000|Participant Flow|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
10993426|NCT01018979|FG001|Participant Flow|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
10993427|NCT01018979|OG000|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
10993428|NCT01018979|OG001|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
10993429|NCT01018979|OG000|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
10993430|NCT01018979|OG001|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
10993431|NCT01018979|OG002|Outcome|All Patients|All patents = MM + NHL + HD
10993432|NCT01018979|EG000|Reported Event|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
10993433|NCT01018979|EG001|Reported Event|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
10993434|NCT01018992|BG000|Baseline|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
10993435|NCT01018992|BG001|Baseline|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
10993436|NCT01018992|BG002|Baseline|Total|Total of all reporting groups
10993437|NCT01018992|FG000|Participant Flow|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
10993438|NCT01018992|FG001|Participant Flow|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
10993439|NCT01018992|OG000|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
10993440|NCT01018992|OG001|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
10993441|NCT01018992|EG000|Reported Event|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
10993442|NCT01018992|EG001|Reported Event|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
10993443|NCT01019135|BG000|Baseline|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993444|NCT01019135|BG001|Baseline|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993445|NCT01019135|BG002|Baseline|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993446|NCT01019135|BG003|Baseline|Total|Total of all reporting groups
10993447|NCT01019135|FG000|Participant Flow|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993448|NCT01019135|FG001|Participant Flow|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993449|NCT01019135|FG002|Participant Flow|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993450|NCT01019135|OG000|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993451|NCT01019135|OG001|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993452|NCT01019135|OG002|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993453|NCT01019135|EG000|Reported Event|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993454|NCT01019135|EG001|Reported Event|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993455|NCT01019135|EG002|Reported Event|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
10993456|NCT01019252|BG000|Baseline|CBT First, Then Follow-up|"All participants completed seven modules of treatment over twelve sessions, ten of which were 1:1 with the therapist and adolescent, and two of which also included the parent. Two additional optional parent-only sessions were offered as well. For each 1:1 session the parent was included for approximately ten minutes, generally at the end of the session, to discuss progress, the course of intervention content, and how the parent could assist with any take-home practice.~Modules were adapted from the PI's intervention designed for ADHD in adults. Modules included: psychoeducation and organization/planning (4 session); distractibility (2 sessions); adaptive thinking/cognitive restructuring (2 sessions); procrastination (1 session); parent-adolescent sessions (2 sessions); parent-only sessions (1 session); relapse prevention (1 session)."
10993457|NCT01019252|BG001|Baseline|Wait List First, Then CBT|Participants initially assigned to the wait list were informed by the research assistant that they had been randomized to the wait list condition. For those who were still willing to cross-over to receive CBT, the research assistant contacted parents to schedule the 4-month assessment visit with the independent evaluator and the first CBT session after the evaluation for participants.
10993458|NCT01019252|BG002|Baseline|Total|Total of all reporting groups
10993459|NCT01019252|FG000|Participant Flow|CBT for ADHD First, Then Follow-up|"All participants completed seven modules of treatment over twelve sessions, ten of which were 1:1 with the therapist and adolescent, and two of which also included the parent. Two additional optional parent-only sessions were offered as well. For each 1:1 session the parent was included for approximately ten minutes, generally at the end of the session, to discuss progress, the course of intervention content, and how the parent could assist with any take-home practice. 21 of the participants crossed-over to the wait list condition (received no further treatment) between the 4-month and 8-month assessments.~Modules were adapted from the PI's intervention designed for ADHD in adults. Modules included: psychoeducation and organization/planning (4 session); distractibility (2 sessions); adaptive thinking/cognitive restructuring (2 sessions); procrastination (1 session); parent-adolescent sessions (2 sessions); parent-only sessions (1 session); relapse prevention (1 session)."
10993460|NCT01019252|FG001|Participant Flow|Wait List First, Then CBT for ADHD|Participants initially assigned to the wait list were informed by the research assistant that they had been randomized to the wait list condition. For those who were still willing to cross-over to receive CBT, the research assistant contacted parents to schedule the 4-month assessment visit with the independent evaluator and the first CBT session after the evaluation for participants. 19 participants crossed-over to receive CBT between the 4-month and 8-month assessments. Of the 19 who crossed-over, 15 completed the CBT treatment.
10993461|NCT01019252|OG000|Outcome|Cognitive Behavioral Therapy (CBT) for ADHD|"All participants completed seven modules of treatment over twelve sessions, ten of which were 1:1 with the therapist and adolescent, and two of which also included the parent. Two additional optional parent-only sessions were offered as well. For each 1:1 session the parent was included for approximately ten minutes, generally at the end of the session, to discuss progress, the course of intervention content, and how the parent could assist with any take-home practice.~Modules were adapted from the PI's intervention designed for ADHD in adults. Modules included: psychoeducation and organization/planning (4 session); distractibility (2 sessions); adaptive thinking/cognitive restructuring (2 sessions); procrastination (1 session); parent-adolescent sessions (2 sessions); parent-only sessions (1 session); relapse prevention (1 session)."
10993462|NCT01019252|OG001|Outcome|Wait List Control|Participants initially assigned to the wait list were informed by the research assistant that they had been randomized to the wait list condition. For those who were still willing to cross-over to receive CBT, the research assistant contacted parents to schedule the 4-month assessment visit with the independent evaluator and the first CBT session after the evaluation for participants.
10993463|NCT01019252|EG000|Reported Event|CBT for ADHD First, Then Follow-up|"All participants completed seven modules of treatment over twelve sessions, ten of which were 1:1 with the therapist and adolescent, and two of which also included the parent. Two additional optional parent-only sessions were offered as well. For each 1:1 session the parent was included for approximately ten minutes, generally at the end of the session, to discuss progress, the course of intervention content, and how the parent could assist with any take-home practice.~Modules were adapted from the PI's intervention designed for ADHD in adults. Modules included: psychoeducation and organization/planning (4 session); distractibility (2 sessions); adaptive thinking/cognitive restructuring (2 sessions); procrastination (1 session); parent-adolescent sessions (2 sessions); parent-only sessions (1 session); relapse prevention (1 session)."
10993464|NCT01019252|EG001|Reported Event|Wait List First, Then CBT for ADHD|Participants initially assigned to the wait list were informed by the research assistant that they had been randomized to the wait list condition. For those who were still willing to cross-over to receive CBT, the research assistant contacted parents to schedule the 4-month assessment visit with the independent evaluator and the first CBT session after the evaluation for participants.
10993465|NCT01019317|BG000|Baseline|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
10993466|NCT01019317|FG000|Participant Flow|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
10993467|NCT01019317|OG000|Outcome|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
10993468|NCT01019317|EG000|Reported Event|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
10993469|NCT01019369|BG000|Baseline|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993470|NCT01019369|BG001|Baseline|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993471|NCT01019369|BG002|Baseline|Total|Total of all reporting groups
10993472|NCT01019369|FG000|Participant Flow|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993473|NCT01019369|FG001|Participant Flow|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993474|NCT01019369|OG000|Outcome|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993475|NCT01019369|OG001|Outcome|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993476|NCT01019369|OG000|Outcome|Self Administration of DMPA|"Self administration of subcutaneous depot medroxyprogesterone acetate~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993477|NCT01019369|EG000|Reported Event|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993478|NCT01019369|EG001|Reported Event|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
10993479|NCT01019486|BG000|Baseline|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
10993480|NCT01019486|BG001|Baseline|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
10993481|NCT01019486|BG002|Baseline|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
10993482|NCT01019486|BG003|Baseline|Total|Total of all reporting groups
10993483|NCT01019486|FG000|Participant Flow|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
10876810|NCT00444080|BG001|Baseline|Treatment Arm|"Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C~Ex-PRESS mini shunt: Ex-PRESS implantation procedure:~Creation of a fornix or limbal based conjunctival flap in upper quadrants~Creation of limbal-based scleral flap extending into clear cornea~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus~Prior to implantation, a thorough mobility check should be performed~Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision~Withdrawal of introducer~Tucking plate under the scleral flap, and verification of its position~Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad."
10876811|NCT00444080|BG002|Baseline|Total|Total of all reporting groups
10876812|NCT00444080|FG000|Participant Flow|Control Arm|"Subjects undergoing trabeculectomy with the use of Mitomycin C~Trabeculectomy: Standard trabeculectomy procedure~Creation of a fornix or limbal based conjunctival flap in upper quadrants~Creation of a limbal-based scleral flap extending into clear cornea~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~Creation of fistula 1mm x 2mm in size~Iridectomy~Suturing the scleral flap~Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged."
10876813|NCT00444080|FG001|Participant Flow|Treatment Arm|"Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C~Ex-PRESS mini shunt: Ex-PRESS implantation procedure:~Creation of a fornix or limbal based conjunctival flap in upper quadrants~Creation of limbal-based scleral flap extending into clear cornea~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus~Prior to implantation, a thorough mobility check should be performed~Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision~Withdrawal of introducer~Tucking plate under the scleral flap, and verification of its position~Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad."
10876814|NCT00444080|OG000|Outcome|Control Arm|"Subjects undergoing trabeculectomy with the use of Mitomycin C~Trabeculectomy: Standard trabeculectomy procedure~Creation of a fornix or limbal based conjunctival flap in upper quadrants~Creation of a limbal-based scleral flap extending into clear cornea~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~Creation of fistula 1mm x 2mm in size~Iridectomy~Suturing the scleral flap~Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged."
10876815|NCT00444080|OG001|Outcome|Treatment Arm|"Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C~Ex-PRESS mini shunt procedure:~Creation of a fornix or limbal based conjunctival flap in upper quadrants~Creation of limbal-based scleral flap extending into clear cornea~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus~Prior to implantation, a thorough mobility check should be performed~Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision~Withdrawal of introducer~Tucking plate under the scleral flap, and verification of its position~Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged."
10876816|NCT00444080|OG000|Outcome|Control Arm|Subjects undergoing trabeculectomy with the use of Mitomycin C
10876817|NCT00444080|OG001|Outcome|Treatment Arm|Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
10876818|NCT00444080|OG001|Outcome|Treatment Arm|"Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C~Ex-PRESS mini shunt implantation procedure:~Creation of a fornix or limbal based conjunctival flap in upper quadrants~Creation of limbal-based scleral flap extending into clear cornea~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus~Prior to implantation, a thorough mobility check should be performed~Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision~Withdrawal of introducer~Tucking plate under the scleral flap, and verification of its position~Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged."
10876819|NCT00444080|EG000|Reported Event|Control Arm|Subjects undergoing trabeculectomy with the use of Mitomycin C
10876820|NCT00444080|EG001|Reported Event|Treatment Arm|Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
10876821|NCT00444106|BG000|Baseline|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
10876822|NCT00444106|BG001|Baseline|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
10876823|NCT00444106|BG002|Baseline|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
10876824|NCT00444106|BG003|Baseline|Total|Total of all reporting groups
10876825|NCT00444106|FG000|Participant Flow|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
10876826|NCT00444106|FG001|Participant Flow|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
10876827|NCT00444106|FG002|Participant Flow|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
10993484|NCT01019486|FG001|Participant Flow|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
10993485|NCT01019486|FG002|Participant Flow|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
10993486|NCT01019486|OG000|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
10993487|NCT01019486|OG001|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
10993488|NCT01019486|OG002|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
10993489|NCT01019486|OG000|Outcome|Abnormal MPI Study|These subjects demonstrated abnormal radionuclide myocardial perfusion imaging studies with perfusion defects in response to regadenoson stress. The perfusion defect qualified the subject to participated in invasive CFR measurements. Coronary arteries within the region of the perfusion defect were cannulated for CFR measurements. Flow measurements were performed in the 2 normal vessels and the abnormal vessel both at rest and following regadenoson administration to calculated CFR values..
10993490|NCT01019486|EG000|Reported Event|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
10993491|NCT01019486|EG001|Reported Event|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
10993492|NCT01019486|EG002|Reported Event|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
10993493|NCT01019694|BG000|Baseline|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
10993494|NCT01019694|BG001|Baseline|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
10993495|NCT01019694|BG002|Baseline|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
10993496|NCT01019694|BG003|Baseline|Total|Total of all reporting groups
10993497|NCT01019694|FG000|Participant Flow|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
10993498|NCT01019694|FG001|Participant Flow|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
10993499|NCT01019694|FG002|Participant Flow|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
10993500|NCT01019694|OG000|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
10993501|NCT01019694|OG001|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
10993502|NCT01019694|OG002|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
10993503|NCT01019694|EG000|Reported Event|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
10993504|NCT01019694|EG001|Reported Event|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
10993505|NCT01019694|EG002|Reported Event|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
10993506|NCT01019707|BG000|Baseline|Total Sample|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine and placebo. The order of study drug was determined randomly.
10993507|NCT01019707|FG000|Participant Flow|Atomoxetine, Then Placebo|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine for 15 days and then placebo for 9 days after a 14 day wash out. The order of study drug was determined randomly.
10993508|NCT01019707|FG001|Participant Flow|Placebo, Then Atomoxetine|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under placebo for 15 days and then atomoxetine for 9 days after a 14 day wash out. The order of study drug was determined randomly.
10993509|NCT01019707|OG000|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
10993510|NCT01019707|OG001|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
10993511|NCT01019707|EG000|Reported Event|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
10993512|NCT01019707|EG001|Reported Event|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
10993513|NCT01019928|BG000|Baseline|AZD1386 95 mg|
10993514|NCT01019928|BG001|Baseline|Placebo|
10993515|NCT01019928|BG002|Baseline|Total|Total of all reporting groups
10993516|NCT01019928|FG000|Participant Flow|First AZD1386, Then Washout, Then Placebo|
10993517|NCT01019928|FG001|Participant Flow|First Placebo, Then Washout, Then AZD1386|
10993518|NCT01019928|OG000|Outcome|AZD1386 95 mg|
10993519|NCT01019928|OG001|Outcome|Placebo|
10993520|NCT01019928|EG000|Reported Event|AZD1386 95 mg|
10993521|NCT01019928|EG001|Reported Event|Placebo|
10993522|NCT01020006|BG000|Baseline|(PCI-27483 + Gemcitabine)/Part A|
10993523|NCT01020006|BG001|Baseline|(PCI-27483 + Gemcitabine)/Part B|
10993524|NCT01020006|BG002|Baseline|Gemcitabine/Part B|
10993525|NCT01020006|BG003|Baseline|Total|Total of all reporting groups
10993526|NCT01020006|FG000|Participant Flow|PCI-27483 + Gemcitabine/Part A|Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
10993527|NCT01020006|FG001|Participant Flow|PCI-27483 + Gemcitabine/Part B|Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
10876828|NCT00444106|OG000|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
10876829|NCT00444106|OG000|Outcome|Artemether-lumefantrine|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
10876830|NCT00444106|OG001|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
10876831|NCT00444106|OG002|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
10876832|NCT00444106|OG001|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
10876833|NCT00444106|OG002|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
10876834|NCT00444106|EG000|Reported Event|Artemether-lumefantrine|Artemether-lumefantrine
10876835|NCT00444106|EG001|Reported Event|Atovaquone-proguanil|Atovaquone-proguanil
10876836|NCT00444106|EG002|Reported Event|Artesunate-Mefloquine|Artesunate-Mefloquine
10876837|NCT00444145|BG000|Baseline|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
10876838|NCT00444145|FG000|Participant Flow|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
10876839|NCT00444145|OG000|Outcome|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
10876840|NCT00444145|EG000|Reported Event|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
10876841|NCT00444275|BG000|Baseline|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
10876842|NCT00444275|BG001|Baseline|Esomeprazole 20 mg on Demand (Maintenance Phase)|
10876843|NCT00444275|BG002|Baseline|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
10876844|NCT00444275|BG003|Baseline|Total|Total of all reporting groups
10876845|NCT00444275|FG000|Participant Flow|Esomeprazole 20 mg Once Daily (Initial Phase)|
10876846|NCT00444275|FG001|Participant Flow|Esomeprazole 40 mg Once Daily (Initial Phase)|
10876847|NCT00444275|FG002|Participant Flow|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
10876848|NCT00444275|FG003|Participant Flow|Esomeprazole 20 mg on Demand (Maintenance Phase)|
10876849|NCT00444275|FG004|Participant Flow|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
10876850|NCT00444275|OG000|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
10876851|NCT00444275|OG001|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
10876852|NCT00444275|OG002|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
10876853|NCT00444275|OG000|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
10876854|NCT00444275|OG001|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
10876855|NCT00444275|OG002|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
10876856|NCT00444275|OG003|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
10876857|NCT00444275|OG004|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
10876858|NCT00444275|EG000|Reported Event|Esomeprazole 20 mg Once Daily (Initial Phase)|
10876859|NCT00444275|EG001|Reported Event|Esomeprazole 40 mg Once Daily (Initial Phase)|
10876860|NCT00444275|EG002|Reported Event|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
10876861|NCT00444275|EG003|Reported Event|Esomeprazole 20 mg on Demand (Maintenance Phase)|
10876862|NCT00444275|EG004|Reported Event|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
10876863|NCT00444457|BG000|Baseline|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876864|NCT00444457|BG001|Baseline|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10993528|NCT01020006|FG002|Participant Flow|Gemcitabine/Part B|Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
10993529|NCT01020006|OG000|Outcome|(PCI-27483 + Gemcitabine)/Part A|
10993530|NCT01020006|OG001|Outcome|(PCI-27483 + Gemcitabine)/Part B|
10993531|NCT01020006|OG002|Outcome|Gemcitabine/Part B|
10993532|NCT01020006|EG000|Reported Event|(PCI-27483 + Gemcitabine)/Part A|"Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
10993533|NCT01020006|EG001|Reported Event|(PCI-27483 + Gemcitabine)/Part B|"Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
10993534|NCT01020006|EG002|Reported Event|Gemcitabine/Part B|"Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
10993535|NCT01020019|BG000|Baseline|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
10993536|NCT01020019|BG001|Baseline|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
10993537|NCT01020019|BG002|Baseline|Total|Total of all reporting groups
10993538|NCT01020019|FG000|Participant Flow|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
10993539|NCT01020019|FG001|Participant Flow|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
10993540|NCT01020019|OG000|Outcome|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
10993541|NCT01020019|OG001|Outcome|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
10993542|NCT01020019|EG000|Reported Event|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
10993543|NCT01020019|EG001|Reported Event|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
10993544|NCT01020123|BG000|Baseline|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
10993545|NCT01020123|BG001|Baseline|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
10993546|NCT01020123|BG002|Baseline|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
10993547|NCT01020123|BG003|Baseline|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
10993548|NCT01020123|BG004|Baseline|Placebo|Placebo add on to metformin
10993549|NCT01020123|BG005|Baseline|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
10993550|NCT01020123|BG006|Baseline|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
10993551|NCT01020123|BG007|Baseline|Total|Total of all reporting groups
10993552|NCT01020123|FG000|Participant Flow|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
10993553|NCT01020123|FG001|Participant Flow|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
10993554|NCT01020123|FG002|Participant Flow|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
10993555|NCT01020123|FG003|Participant Flow|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
10993556|NCT01020123|FG004|Participant Flow|Placebo|Placebo add on to metformin
10993557|NCT01020123|FG005|Participant Flow|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
10993558|NCT01020123|FG006|Participant Flow|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
10993559|NCT01020123|OG000|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
10993560|NCT01020123|OG001|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
10993561|NCT01020123|OG002|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
10993562|NCT01020123|OG003|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
10993563|NCT01020123|OG004|Outcome|Placebo|Placebo add on to metformin
10993564|NCT01020123|OG005|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
10993565|NCT01020123|OG006|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
10993566|NCT01020123|OG004|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
10993567|NCT01020123|EG000|Reported Event|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
10993568|NCT01020123|EG001|Reported Event|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
10993569|NCT01020123|EG002|Reported Event|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
10993570|NCT01020123|EG003|Reported Event|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
10993571|NCT01020123|EG004|Reported Event|Placebo|Placebo add on to metformin
10993572|NCT01020123|EG005|Reported Event|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
10993573|NCT01020123|EG006|Reported Event|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
10993574|NCT01020305|BG000|Baseline|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
10993575|NCT01020305|FG000|Participant Flow|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
10993576|NCT01020305|OG000|Outcome|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
10993577|NCT01020305|EG000|Reported Event|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
10993578|NCT01020435|BG000|Baseline|Spinal Manipulation High Velocity|"This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant's head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of the head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.~Spinal Manipulation is the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted)."
10993579|NCT01020435|BG001|Baseline|Sham Spinal Manipulation|"The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.~Sham Spinal Manipulation: The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same."
10993580|NCT01020435|BG002|Baseline|Total|Total of all reporting groups
10993581|NCT01020435|FG000|Participant Flow|Spinal Manipulation High Velocity|"This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant's head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of the head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.~Spinal Manipulation is the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted)."
10993582|NCT01020435|FG001|Participant Flow|Sham Spinal Manipulation|"The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.~Sham Spinal Manipulation: The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same."
10993583|NCT01020435|OG000|Outcome|Spinal Manipulation High Velocity|"This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant's head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of the head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.~Spinal Manipulation is the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted)."
10993584|NCT01020435|OG001|Outcome|Sham Spinal Manipulation|"The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.~Sham Spinal Manipulation: The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same."
10993585|NCT01020435|OG000|Outcome|Feasibility Outcomes|Participants recruited, consented, enrolled, and retained, & duration of study from launch date to final outcomes.
11099034|NCT01579318|FG000|Participant Flow|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
10993586|NCT01020435|EG000|Reported Event|Spinal Manipulation High Velocity*|"This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant's head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of the head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.~Spinal Manipulation is the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted)."
10993587|NCT01020435|EG001|Reported Event|Sham Spinal Manipulation*|"The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.~Sham Spinal Manipulation: The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same."
10993588|NCT01020448|BG000|Baseline|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
10993589|NCT01020448|FG000|Participant Flow|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
10993590|NCT01020448|OG000|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
10993591|NCT01020448|OG000|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
10993592|NCT01020448|EG000|Reported Event|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
10993593|NCT01020474|BG000|Baseline|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
10993594|NCT01020474|BG001|Baseline|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
10993595|NCT01020474|BG002|Baseline|Total|Total of all reporting groups
10993596|NCT01020474|FG000|Participant Flow|Pregabalin|Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
10993597|NCT01020474|FG001|Participant Flow|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
10993598|NCT01020474|OG000|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
10993599|NCT01020474|OG001|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
10993600|NCT01020474|EG000|Reported Event|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
10993601|NCT01020474|EG001|Reported Event|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
10993602|NCT01020487|BG000|Baseline|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
10993603|NCT01020487|BG001|Baseline|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
10993604|NCT01020487|BG002|Baseline|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
10993605|NCT01020487|BG003|Baseline|Total|Total of all reporting groups
10993606|NCT01020487|FG000|Participant Flow|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
10993607|NCT01020487|FG001|Participant Flow|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
10993608|NCT01020487|FG002|Participant Flow|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
10993609|NCT01020487|OG000|Outcome|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
11099035|NCT01579318|OG000|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
11099036|NCT01579318|EG000|Reported Event|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
11099037|NCT01579474|BG000|Baseline|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
10876865|NCT00444457|BG002|Baseline|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876866|NCT00444457|BG003|Baseline|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876867|NCT00444457|BG004|Baseline|Total|Total of all reporting groups
10876868|NCT00444457|FG000|Participant Flow|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876869|NCT00444457|FG001|Participant Flow|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876870|NCT00444457|FG002|Participant Flow|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876871|NCT00444457|FG003|Participant Flow|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10879564|NCT00458484|FG000|Participant Flow|Series 1/Dose Level 1: Stereotactic Radiosurgery|"Dose Level I: Radiation will be delivered in 4 fractions:~6 Gy x 4 fractions: Total of 24 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
11099038|NCT01579474|BG001|Baseline|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
11099039|NCT01579474|BG002|Baseline|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
11099040|NCT01579474|BG003|Baseline|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
10993610|NCT01020487|OG000|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
10993611|NCT01020487|OG001|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
10993612|NCT01020487|EG000|Reported Event|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
10993613|NCT01020487|EG001|Reported Event|Part 2: Placebo|Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase.
11348232|NCT04195581|BG000|Baseline|Overall Study|Subjects were randomized to use each lens and solution combination for a month in random sequence; that is for a total of six months. Lenses (comfilcon A and fanfilcon A), Lens care solutions(Hy-Care, All in One Light and Refine One Step).
10993614|NCT01020487|EG002|Reported Event|Part 2: Paricalcitol|Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels.
10993615|NCT01020487|EG003|Reported Event|Part 2: Placebo/Paricalcitol|Participants who received placebo in the double-blind treatment phase received open-label paricalcitol at an initial dose of 1 µg three times a week in the open- label treatment phase (Weeks 12-24). Doses could be adjusted based on chemistry evaluations to target KDOQI levels.
10993616|NCT01020487|EG004|Reported Event|Part 2: Paricalcitol/Paricalcitol|Participants who received paricalcitol during the double-blind treatment period continued to receive paricalcitol three times a week during the open-label period (Weeks 12-24).
10993617|NCT01020526|BG000|Baseline|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
10993618|NCT01020526|FG000|Participant Flow|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
10993619|NCT01020526|OG000|Outcome|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
10993620|NCT01020526|EG000|Reported Event|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
10993621|NCT01020591|BG000|Baseline|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
10993622|NCT01020591|BG001|Baseline|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
10993623|NCT01020591|BG002|Baseline|Total|Total of all reporting groups
10993624|NCT01020591|FG000|Participant Flow|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
10993625|NCT01020591|FG001|Participant Flow|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
10993626|NCT01020591|OG000|Outcome|Pre Test to the Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
10993627|NCT01020591|OG001|Outcome|Pre Test to the Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
10993628|NCT01020591|OG002|Outcome|Same Day Post Test to Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
10993629|NCT01020591|OG003|Outcome|Post Test to Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
10993630|NCT01020591|EG000|Reported Event|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
10993631|NCT01020591|EG001|Reported Event|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
10993632|NCT01020747|BG000|Baseline|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
10993633|NCT01020747|FG000|Participant Flow|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
10846483|NCT00276406|EG000|Reported Event|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
10846484|NCT00276406|EG001|Reported Event|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
10846485|NCT00276549|BG000|Baseline|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
10846486|NCT00276549|FG000|Participant Flow|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
10846487|NCT00276549|OG000|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
10846488|NCT00276549|EG000|Reported Event|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
10846489|NCT00276614|BG000|Baseline|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
10846490|NCT00276614|FG000|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
10846491|NCT00276614|OG000|Outcome|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
10993634|NCT01020747|OG000|Outcome|Bevacizumab Treated Vocal Fold|Subjects received injections of bevacizumab in conjunction with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the more diseased vocal fold.
10993635|NCT01020747|OG001|Outcome|Untreated Vocal Fold|Subjects received saline injections in combination with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the less diseased vocal fold.
10993636|NCT01020747|EG000|Reported Event|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
10993637|NCT01020773|BG000|Baseline|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
10993638|NCT01020773|BG001|Baseline|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
10993639|NCT01020773|BG002|Baseline|Total|Total of all reporting groups
10993640|NCT01020773|FG000|Participant Flow|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
10993641|NCT01020773|FG001|Participant Flow|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
10993642|NCT01020773|OG000|Outcome|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
10993643|NCT01020773|OG001|Outcome|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
10993644|NCT01020773|EG000|Reported Event|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
10993645|NCT01020773|EG001|Reported Event|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
10993646|NCT01020786|BG000|Baseline|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
10993647|NCT01020786|FG000|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
10993648|NCT01020786|OG000|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m2) of pemetrexed given intravenously (IV) on Day 1 of every 21 day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 for participant, given IV on Day 1 of every 21 day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m2 of pemetrexed given IV on Day 1 of every 21 day cycle until disease progression or unacceptable toxicity."
10993649|NCT01020786|OG000|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
11099041|NCT01579474|BG004|Baseline|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
11099042|NCT01579474|BG005|Baseline|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
11099043|NCT01579474|BG006|Baseline|Total|Total of all reporting groups
11099044|NCT01579474|FG000|Participant Flow|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients.
11099045|NCT01579474|FG001|Participant Flow|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
11099046|NCT01579474|FG002|Participant Flow|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
11099047|NCT01579474|FG003|Participant Flow|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
11099048|NCT01579474|FG004|Participant Flow|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
11099049|NCT01579474|FG005|Participant Flow|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
11099050|NCT01579474|OG000|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
11099051|NCT01579474|OG001|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
11099052|NCT01579474|OG002|Outcome|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
11099053|NCT01579474|OG002|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined withPegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
11099054|NCT01579474|OG003|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
11099055|NCT01579474|OG004|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
11099056|NCT01579474|OG005|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
11099057|NCT01579474|OG002|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
11099058|NCT01579474|EG000|Reported Event|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
11099059|NCT01579474|EG001|Reported Event|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
11099060|NCT01579474|EG002|Reported Event|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
11099061|NCT01579513|BG000|Baseline|Intraoperative Methylprednisone|"Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.~Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia."
11099062|NCT01579513|BG001|Baseline|Placebo|"Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.~Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia."
11099063|NCT01579513|BG002|Baseline|Total|Total of all reporting groups
11099064|NCT01579513|FG000|Participant Flow|Intraoperative Methylprednisone|"Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.~Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia."
11099065|NCT01579513|FG001|Participant Flow|Placebo|"Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.~Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia."
10846492|NCT00276614|EG000|Reported Event|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
10846535|NCT00277446|BG000|Baseline|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
10879565|NCT00458484|FG001|Participant Flow|Series 1/Dose Level 2: Stereotactic Radiosurgery|"Dose Level 2: Radiation will be delivered in 4 fractions:~8 Gy x 4 fractions: Total of 32 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
11099066|NCT01579513|OG000|Outcome|Intraoperative Methylprednisone|"Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.~Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia."
11099067|NCT01579513|OG001|Outcome|Placebo|"Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.~Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia."
11099068|NCT01579513|EG000|Reported Event|Intraoperative Methylprednisone|"Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.~Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia."
11223264|NCT02352493|BG017|Baseline|ALN-CC5 Multiple Dose - Eculizumab Naive|Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
10846536|NCT00277446|FG000|Participant Flow|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
10846537|NCT00277446|OG000|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
10846538|NCT00277446|EG000|Reported Event|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
10846539|NCT00277524|BG000|Baseline|Overall|All patients enrolled in OMNI.
10846540|NCT00277524|FG000|Participant Flow|Subjects With IPG|Subjects implanted with an implantable pulse generator (IPG).
11223265|NCT02352493|BG018|Baseline|Total|Total of all reporting groups
10846541|NCT00277524|FG001|Participant Flow|Subjects With Single Chamber ICD|Subjects implanted with a single chamber implantable cardioverter defibrillator (ICD).
10846542|NCT00277524|FG002|Participant Flow|Subjects With Dual Chamber ICD|Subjects implanted with a dual chamber implantable cardioverter defibrillator (ICD).
10846543|NCT00277524|FG003|Participant Flow|Subjects With CRT-D|Subjects implanted with a cardiac resynchronization therapy defibrillator (CRT-D).
10846544|NCT00277524|OG000|Outcome|Implanted Subjects|All patients enrolled in OMNI.
10846545|NCT00277524|OG000|Outcome|IPG Group|Subjects implanted with IPG
10846546|NCT00277524|OG000|Outcome|ICD/CRT-D Group|Subjects implanted with ICD/CRT-D
10846547|NCT00277524|OG000|Outcome|IPG (N=610)|IPG Patients with MVP enabled and follow up data available
10846548|NCT00277524|OG001|Outcome|ICD (N=1029)|ICD Patients with MVP enabled and follow up data available
10846549|NCT00277524|OG000|Outcome|Patients Without History of AV Block|Patients with MVP enabled and follow up data available
10846550|NCT00277524|OG001|Outcome|Patients With History of AV Block|Patients with MVP enabled and follow up data available
10846551|NCT00277524|OG000|Outcome|ATP During Charging|Patients who had an episode and were programmed with the ATP during charging feature.
10846552|NCT00277524|OG000|Outcome|"PainFREE Programming"|"OMNI PainFREE definition: programming combinations that result in ATP therapy for VT at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated."
10846553|NCT00277524|OG001|Outcome|"SCD-HeFT Programming"|"OMNI SCD-HeFT definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms."
10846554|NCT00277524|OG000|Outcome|12-month Follow-up|Total subjects with disease progressed at 12 months
10846555|NCT00277524|OG001|Outcome|24-month Follow-up|Total subjects with disease progressed at 24 months
10846556|NCT00277524|OG002|Outcome|36-month Follow-up|Total subjects with disease progressed at 36 months
10846557|NCT00277524|OG003|Outcome|48-month Follow-up|Total subjects with disease progressed at 48 months
10846558|NCT00277524|OG000|Outcome|ICD/CRT-D Group|Subjects implanted with Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy-Defibrillator (ICD/CRT-D).
10846559|NCT00277524|EG000|Reported Event||The Medtronic OMNI Study is a post-market observational study conducted in the United States (US). Adverse events were not collected as a part of the OMNI study. Sites were instructed to report applicable events in the same manner as required for any commercially available device, through the Medical Device Reporting (MDR) process.
10846560|NCT00278109|BG000|Baseline|Experimental|"cyclophosphamide: chemotherapy~doxorubicin hydrochloride: chemotherapy~adjuvant therapy: chemotherapy~radiation therapy: chemotherapy"
10846561|NCT00278109|FG000|Participant Flow|Experimental|"cyclophosphamide: chemotherapy~doxorubicin hydrochloride: chemotherapy~adjuvant therapy: chemotherapy~radiation therapy: chemotherapy"
10846562|NCT00278109|OG000|Outcome|Experimental|"cyclophosphamide: chemotherapy~doxorubicin hydrochloride: chemotherapy~adjuvant therapy: chemotherapy~radiation therapy: chemotherapy"
10846563|NCT00278109|EG000|Reported Event|Experimental|"cyclophosphamide: chemotherapy~doxorubicin hydrochloride: chemotherapy~adjuvant therapy: chemotherapy~radiation therapy: chemotherapy"
10876872|NCT00444457|OG000|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876873|NCT00444457|OG001|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876874|NCT00444457|OG002|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876875|NCT00444457|OG000|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876876|NCT00444457|OG001|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
10876877|NCT00444457|OG000|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
10876878|NCT00444457|OG001|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
10876879|NCT00444457|OG002|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
10876880|NCT00444457|OG003|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
10876881|NCT00444457|EG000|Reported Event|Infant Series 13vPnC (Pilot Lot 1)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373."
11223266|NCT02352493|FG000|Participant Flow|Placebo - Single Ascending Dose|Healthy volunteers received a single dose of placebo (normal saline)
11223267|NCT02352493|FG001|Participant Flow|ALN-CC5 50mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 50mg
11223268|NCT02352493|FG002|Participant Flow|ALN-CC5 50mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 50mg
11223269|NCT02352493|FG003|Participant Flow|ALN-CC5 200mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 200mg
11223270|NCT02352493|FG004|Participant Flow|ALN-CC5 200mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 200mg
11223271|NCT02352493|FG005|Participant Flow|ALN-CC5 400mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 400mg
11223272|NCT02352493|FG006|Participant Flow|ALN-CC5 600mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 600mg
10876882|NCT00444457|EG001|Reported Event|Infant Series 13vPnC (Pilot Lot 2)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364."
11223273|NCT02352493|FG007|Participant Flow|ALN-CC5 600mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 600mg
11223274|NCT02352493|FG008|Participant Flow|ALN-CC5 900mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 900mg
11223275|NCT02352493|FG009|Participant Flow|Placebo - Multiple Ascending Dose|Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
11223276|NCT02352493|FG010|Participant Flow|ALN-CC5 100mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
11223277|NCT02352493|FG011|Participant Flow|ALN-CC5 200mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
11223278|NCT02352493|FG012|Participant Flow|ALN-CC5 400mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
11223279|NCT02352493|FG013|Participant Flow|ALN-CC5 600mg Biweekly - Multiple Ascending Dose|Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
11223280|NCT02352493|FG014|Participant Flow|ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
11223281|NCT02352493|FG015|Participant Flow|ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
11223282|NCT02352493|FG016|Participant Flow|ALN-CC5 Multiple Dose - Eculizumab Treated|Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
11223283|NCT02352493|FG017|Participant Flow|ALN-CC5 Multiple Dose - Eculizumab Naive|Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
11223284|NCT02352493|OG000|Outcome|Placebo - Single Ascending Dose|Healthy volunteers received a single dose of placebo (normal saline)
11223285|NCT02352493|OG001|Outcome|ALN-CC5 50mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 50mg
11223286|NCT02352493|OG002|Outcome|ALN-CC5 50mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 50mg
11223287|NCT02352493|OG003|Outcome|ALN-CC5 200mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 200mg
11223288|NCT02352493|OG004|Outcome|ALN-CC5 200mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 200mg
11223289|NCT02352493|OG005|Outcome|ALN-CC5 400mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 400mg
11223290|NCT02352493|OG006|Outcome|ALN-CC5 600mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 600mg
11223291|NCT02352493|OG007|Outcome|ALN-CC5 600mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 600mg
11223292|NCT02352493|OG008|Outcome|ALN-CC5 900mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 900mg
11223293|NCT02352493|OG009|Outcome|Placebo - Multiple Ascending Dose|Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
11223294|NCT02352493|OG010|Outcome|ALN-CC5 100mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
11223295|NCT02352493|OG011|Outcome|ALN-CC5 200mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
11223296|NCT02352493|OG012|Outcome|ALN-CC5 400mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
11223297|NCT02352493|OG013|Outcome|ALN-CC5 600mg Biweekly - Multiple Ascending Dose|Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
11223298|NCT02352493|OG014|Outcome|ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
11223299|NCT02352493|OG015|Outcome|ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
10993650|NCT01020786|EG000|Reported Event|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
10993651|NCT01020799|BG000|Baseline|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
10993652|NCT01020799|BG001|Baseline|Placebo|Placebo matching both AZD7268 and escitalopram
10993653|NCT01020799|BG002|Baseline|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
10993654|NCT01020799|BG003|Baseline|Total|Total of all reporting groups
10993655|NCT01020799|FG000|Participant Flow|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
10993656|NCT01020799|FG001|Participant Flow|Placebo|Placebo matching both AZD7268 and escitalopram
10993657|NCT01020799|FG002|Participant Flow|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
11223300|NCT02352493|OG016|Outcome|ALN-CC5 Multiple Dose - Eculizumab Treated|Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
10993658|NCT01020799|OG000|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
10993659|NCT01020799|OG001|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
10993660|NCT01020799|OG002|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
10993661|NCT01020799|EG000|Reported Event|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
10993662|NCT01020799|EG001|Reported Event|Placebo|Placebo matching both AZD7268 and escitalopram
10993663|NCT01020799|EG002|Reported Event|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
10993664|NCT01020812|BG000|Baseline|Stereotactic Body Radiotherapy (SBRT)|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
10993665|NCT01020812|FG000|Participant Flow|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
10993666|NCT01020812|OG000|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
10993667|NCT01020812|EG000|Reported Event|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
10993668|NCT01020838|BG000|Baseline|Safety Analysis Set|All study participants who received any amount of florbetaben were included in the safety analysis set.
10993669|NCT01020838|FG000|Participant Flow|All Study Participants|All patients enrolling into the study
10993670|NCT01020838|OG000|Outcome|Sensitivity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
10993671|NCT01020838|OG001|Outcome|Specificity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
11223301|NCT02352493|OG017|Outcome|ALN-CC5 Multiple Dose - Eculizumab Naive|Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
11223302|NCT02352493|OG000|Outcome|ALN-CC5 50mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 50mg
11223303|NCT02352493|OG001|Outcome|ALN-CC5 50mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 50mg
10993672|NCT01020838|OG000|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
10993673|NCT01020838|OG000|Outcome|Sensitivity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Sensitivity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
10993674|NCT01020838|OG001|Outcome|Specificity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Specificity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
10993675|NCT01020838|OG000|Outcome|Initial Drug Administration|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Descriptive statistics of subject level Composite SUVR by SOT for baseline scans and last available scans are reported.
10993676|NCT01020838|OG001|Outcome|1st Repeat Drug Administration|The analysis set consisted of data from 20 subjects with brain specimens available.
10993677|NCT01020838|OG002|Outcome|2nd Repeat Drug Administration|The analysis set consisted of data from 3 subjects with brain specimens available.
10993678|NCT01020838|EG000|Reported Event|Initial Drug Administration|Subjects with TEAEs within 7 days of the initial administration of florbetaben.
10993679|NCT01020838|EG001|Reported Event|1st Repeat Drug Administration|Subjects with TEAEs within 7 days of the 1st repeat drug administration.
10993680|NCT01020838|EG002|Reported Event|2nd Repeat Drug Administration|Subjects with TEAEs within 7 days of the 2nd repeat drug administration.
10993681|NCT01020877|BG000|Baseline|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
10993682|NCT01020877|BG001|Baseline|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
10993683|NCT01020877|BG002|Baseline|Total|Total of all reporting groups
10993684|NCT01020877|FG000|Participant Flow|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
10993685|NCT01020877|FG001|Participant Flow|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
10993686|NCT01020877|OG000|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
10993687|NCT01020877|OG001|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
10993688|NCT01020877|EG000|Reported Event|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
10993689|NCT01020877|EG001|Reported Event|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
10993690|NCT01020981|BG000|Baseline|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
10993691|NCT01020981|BG001|Baseline|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
10993692|NCT01020981|BG002|Baseline|Total|Total of all reporting groups
10993693|NCT01020981|FG000|Participant Flow|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
10993694|NCT01020981|FG001|Participant Flow|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
10993695|NCT01020981|OG000|Outcome|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
10993696|NCT01020981|OG001|Outcome|Indiana Army National Guard|Indiana Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
10993697|NCT01020981|OG000|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
10993698|NCT01020981|OG001|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
10993699|NCT01020981|EG000|Reported Event|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
10993700|NCT01020981|EG001|Reported Event|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
10993701|NCT01021007|BG000|Baseline|Negative Control Rinse|Placebo mouthrinse
10993702|NCT01021007|BG001|Baseline|Iocide Mouthrinse|Experimental mouthrinse
10993703|NCT01021007|BG002|Baseline|Total|Total of all reporting groups
10993704|NCT01021007|FG000|Participant Flow|Negative Control Rinse|Placebo mouthrinse
10993705|NCT01021007|FG001|Participant Flow|Iocide Mouthrinse|Experimental mouthrinse
10993706|NCT01021007|OG000|Outcome|Negative Control Rinse|Placebo mouthrinse
10993707|NCT01021007|OG001|Outcome|Iocide Mouthrinse|Experimental mouthrinse
10993708|NCT01021007|EG000|Reported Event|Negative Control Rinse|Placebo mouthrinse
10993709|NCT01021007|EG001|Reported Event|Iocide Mouthrinse|Experimental mouthrinse
10993710|NCT01021020|BG000|Baseline|Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid|All subjects received all study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
11223304|NCT02352493|OG002|Outcome|ALN-CC5 200mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 200mg
10993711|NCT01021020|FG000|Participant Flow|Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid|All subjects received each of the three study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
10993712|NCT01021020|OG000|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
10993713|NCT01021020|OG001|Outcome|Colchicine (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
10993714|NCT01021020|OG002|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
10993715|NCT01021020|OG000|Outcome|Colchicine 0.6 mg (Fasting)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
10993716|NCT01021020|OG001|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
10993717|NCT01021020|OG002|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasting)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast
10993718|NCT01021020|OG001|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
10993719|NCT01021020|EG000|Reported Event|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6mg after an overnight fast of at least 13.5 hours.
10993720|NCT01021020|EG001|Reported Event|Colchicine 0.6 mg (Fed)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
10993721|NCT01021020|EG002|Reported Event|Colchicine 0.5 mg/Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg after an overnight fast of at least 13.5 hours.
10993722|NCT01021111|BG000|Baseline|Activity Training With Feedback|Subjects who underwent activity training with feedback
10993723|NCT01021111|FG000|Participant Flow|Activity Training With Feedback|"Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities~Anterior Cruciate Ligament Measurement and Feedback System"
10993724|NCT01021111|OG000|Outcome|Activity Training With Feedback|Subjects who underwent activity training with feedback
10993725|NCT01021111|EG000|Reported Event|Activity Training With Feedback|"Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities~Anterior Cruciate Ligament Measurement and Feedback System"
11007470|NCT01090921|FG000|Participant Flow|Bortezomib and Dexamethasone|"Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.~Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.~Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone."
11007471|NCT01090921|OG000|Outcome|Bortezomib and Dexamethasone|"Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.~Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.~Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone."
11007472|NCT01090921|EG000|Reported Event|Bortezomib and Dexamethasone|"Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.~Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.~Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone."
11007473|NCT01090973|BG000|Baseline|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
11007474|NCT01090973|FG000|Participant Flow|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
11007475|NCT01090973|OG000|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
11007476|NCT01090973|EG000|Reported Event|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
10993726|NCT01021137|BG000|Baseline|TBI & Blast|OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure and a diagnosis of mild TBI
10993727|NCT01021137|BG001|Baseline|Blast Only|OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure without TBI
10993728|NCT01021137|BG002|Baseline|TBI Only|OEF/OIF Veterans complaining of dizziness and/or imbalance with a history of mild TBI and no blast exposure
10993729|NCT01021137|BG003|Baseline|Healthy Controls|Age and gender matched control subjects with no complaints of dizziness and/or imbalance or history of TBI or blast exposure
10993730|NCT01021137|BG004|Baseline|Total|Total of all reporting groups
10993731|NCT01021137|FG000|Participant Flow|TBI & Blast|OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure and a diagnosis of mild TBI
10993732|NCT01021137|FG001|Participant Flow|Blast Only|OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure without TBI
10993733|NCT01021137|FG002|Participant Flow|TBI Only|OEF/OIF Veterans complaining of dizziness and/or imbalance with a history of mild TBI and no blast exposure
10993734|NCT01021137|FG003|Participant Flow|Healthy Controls|Age and gender matched control subjects with no complaints of dizziness and/or imbalance or history of TBI or blast exposure
10993735|NCT01021137|OG000|Outcome|TBI & Blast|OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure and a diagnosis of mild TBI
10993736|NCT01021137|OG001|Outcome|Blast Only|OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure without TBI
10993737|NCT01021137|OG002|Outcome|TBI Only|OEF/OIF Veterans complaining of dizziness and/or imbalance with a history of mild TBI and no blast exposure
10993738|NCT01021137|OG003|Outcome|Healthy Controls|Age and gender matched control subjects with no complaints of dizziness and/or imbalance or history of TBI or blast exposure
10993739|NCT01021137|OG003|Outcome|Healthy Controls|Age and gender matched control participants with no complaints of dizziness and/or imbalance or history of TBI or blast exposure
10993740|NCT01021137|EG000|Reported Event|TBI & Blast|OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure and a diagnosis of mild TBI
10993741|NCT01021137|EG001|Reported Event|Blast Only|OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure without TBI
10993742|NCT01021137|EG002|Reported Event|TBI Only|OEF/OIF Veterans complaining of dizziness and/or imbalance with a history of mild TBI and no blast exposure
10993743|NCT01021137|EG003|Reported Event|Healthy Controls|Age and gender matched control subjects with no complaints of dizziness and/or imbalance or history of TBI or blast exposure
10993744|NCT01021215|BG000|Baseline|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
10993745|NCT01021215|BG001|Baseline|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
10993746|NCT01021215|BG002|Baseline|Total|Total of all reporting groups
10993747|NCT01021215|FG000|Participant Flow|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
10993748|NCT01021215|FG001|Participant Flow|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
10993749|NCT01021215|OG000|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
10993750|NCT01021215|OG001|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
10993751|NCT01021215|EG000|Reported Event|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
10993752|NCT01021215|EG001|Reported Event|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
11007477|NCT01091103|BG000|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11007478|NCT01091103|FG000|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11007479|NCT01091103|OG000|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11007480|NCT01091103|OG000|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
11007481|NCT01091103|OG001|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
11007482|NCT01091103|EG000|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11007483|NCT01091116|BG000|Baseline|Low Dose|two doses
11007484|NCT01091116|BG001|Baseline|Mid Dose|two doses
11007485|NCT01091116|BG002|Baseline|High Dose|two doses
11007486|NCT01091116|BG003|Baseline|Single High Dose|one dose+placebo
11007487|NCT01091116|BG004|Baseline|Placebo|two doses
11007488|NCT01091116|BG005|Baseline|Total|Total of all reporting groups
11007489|NCT01091116|FG000|Participant Flow|Low Dose|two intra-articular fasitibant doses; 0.125 mg each
11007490|NCT01091116|FG001|Participant Flow|Mid Dose|two intra-articular fasitibant doses; 0.25 mg each
11007491|NCT01091116|FG002|Participant Flow|High Dose|two intra-articular fasitibant doses; 0.5 mg each
11007492|NCT01091116|FG003|Participant Flow|Single High Dose|one intra-articular fasitibant dose 0.5 mg +placebo
11007493|NCT01091116|FG004|Participant Flow|Placebo|two intra-articular placebo doses
11007494|NCT01091116|OG000|Outcome|Low Dose|two doses
11007495|NCT01091116|OG001|Outcome|Mid Dose|two doses
11007496|NCT01091116|OG002|Outcome|High Dose|two doses
11007497|NCT01091116|OG003|Outcome|Single High Dose|one dose+placebo
11007498|NCT01091116|OG004|Outcome|Placebo|two doses
11007499|NCT01091116|EG000|Reported Event|Low Dose|two doses
11007500|NCT01091116|EG001|Reported Event|Mid Dose|two doses
10993753|NCT04525456|BG000|Baseline|Reduxium|The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
10993754|NCT04525456|FG000|Participant Flow|Reduxium|"1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days~Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days."
10993755|NCT04525456|OG000|Outcome|Reduxium|The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
10993756|NCT04525456|OG000|Outcome|Reduxium|"1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days~Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days."
10993757|NCT04525456|EG000|Reported Event|Reduxium|"1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days~Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days."
11007501|NCT01091116|EG002|Reported Event|High Dose|two doses
11007502|NCT01091116|EG003|Reported Event|Single High Dose|one dose+placebo
11007503|NCT01091116|EG004|Reported Event|Placebo|two doses
11007504|NCT01091155|BG000|Baseline|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
11007505|NCT01091155|FG000|Participant Flow|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
11007506|NCT01091155|OG000|Outcome|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
11007507|NCT01091155|EG000|Reported Event|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
11007508|NCT01091168|BG000|Baseline|Arm A: Vinflunine|"Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.~vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks"
11007509|NCT01091168|BG001|Baseline|Arm B: Alkylating Agent of Physician Choice|"Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.~Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin"
11007510|NCT01091168|BG002|Baseline|Total|Total of all reporting groups
11007511|NCT01091168|FG000|Participant Flow|Vinflunine (VFL)|"Patients randomised in the test arm (arm A) received Vinflunine at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.~vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks"
11007512|NCT01091168|FG001|Participant Flow|Alkylating Agent|"Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.~Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin"
11007513|NCT01091168|OG000|Outcome|Vinflunine|"Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.~vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks"
11007514|NCT01091168|OG001|Outcome|Alkylating Agent|"Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.~Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin"
11007515|NCT01091168|EG000|Reported Event|Vinflunine|"Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.~vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks"
11007516|NCT01091168|EG001|Reported Event|Alkylating Agent|"Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.~Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin"
11007517|NCT01091246|BG000|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
11007518|NCT01091246|BG001|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
11007519|NCT01091246|BG002|Baseline|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
11007520|NCT01091246|BG003|Baseline|Total|Total of all reporting groups
11099069|NCT01579513|EG001|Reported Event|Placebo|"Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.~Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia."
10993758|NCT04161131|BG000|Baseline|ONBOARD Intervention|"ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.~ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)"
10993759|NCT04161131|FG000|Participant Flow|ONBOARD Intervention|"ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to Continuous Glucose Monitor (CGM) use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.~ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)"
10993760|NCT04161131|OG000|Outcome|ONBOARD Intervention|"ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.~ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)"
10993761|NCT04161131|EG000|Reported Event|ONBOARD Intervention|"ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.~ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)"
10993762|NCT04102501|BG000|Baseline|RT001|"9 capsules daily (8.64 g total dose) given as 3 capsules three times a day (TID) with meals for the first month of treatment.~Six capsules daily (5.76 g total dose) given as 3 capsules (BID) with breakfast, and 3 capsules with dinner after the first month of treatment~RT001: RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001."
10993763|NCT04102501|BG001|Baseline|Placebo|"9 capsules daily (8.64 g total dose) given as 3 capsules three times a day (TID) with meals for the first month of treatment.~Six capsules daily (5.76 g total dose) given as 3 capsules (BID) with breakfast, and 3 capsules with dinner after the first month of treatment~Placebo: The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001."
10993764|NCT04102501|BG002|Baseline|Total|Total of all reporting groups
10993765|NCT04102501|FG000|Participant Flow|RT001|"9 capsules daily (8.64 g total dose) given as 3 capsules three times a day (TID) with meals for the first month of treatment.~Six capsules daily (5.76 g total dose) given as 3 capsules (BID) with breakfast, and 3 capsules with dinner after the first month of treatment~RT001: RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001."
10993766|NCT04102501|FG001|Participant Flow|Placebo|"9 capsules daily (8.64 g total dose) given as 3 capsules three times a day (TID) with meals for the first month of treatment.~Six capsules daily (5.76 g total dose) given as 3 capsules (BID) with breakfast, and 3 capsules with dinner after the first month of treatment~Placebo: The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001."
10993767|NCT04102501|OG000|Outcome|RT001|Change from Baseline in MVO2 at 11 months
10993768|NCT04102501|OG001|Outcome|Placebo|Change from Baseline in MVO2 at 11 months
10993769|NCT04102501|OG000|Outcome|RT001|Change from baseline in Timed 1 minute Walk distance
10993770|NCT04102501|OG001|Outcome|Placebo|Change from baseline in the timed 1 minute walk distance
10993771|NCT04102501|EG000|Reported Event|RT001|"9 capsules daily (8.64 g total dose) given as 3 capsules three times a day (TID) with meals for the first month of treatment.~Six capsules daily (5.76 g total dose) given as 3 capsules (BID) with breakfast, and 3 capsules with dinner after the first month of treatment~RT001: RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001."
10993772|NCT04102501|EG001|Reported Event|Placebo|"9 capsules daily (8.64 g total dose) given as 3 capsules three times a day (TID) with meals for the first month of treatment.~Six capsules daily (5.76 g total dose) given as 3 capsules (BID) with breakfast, and 3 capsules with dinner after the first month of treatment~Placebo: The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001."
10993773|NCT04087343|BG000|Baseline|Meals Only|Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
11223305|NCT02352493|OG003|Outcome|ALN-CC5 200mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 200mg
11223306|NCT02352493|OG004|Outcome|ALN-CC5 400mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 400mg
11223307|NCT02352493|OG005|Outcome|ALN-CC5 600mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 600mg
10993774|NCT04087343|BG001|Baseline|Meals Plus Exercise|Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
10993775|NCT04087343|BG002|Baseline|Total|Total of all reporting groups
10993776|NCT04087343|FG000|Participant Flow|Meals Only|Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
10993777|NCT04087343|FG001|Participant Flow|Meals Plus Exercise|Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
10993778|NCT04087343|OG000|Outcome|Meals Only|Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
10993779|NCT04087343|OG001|Outcome|Meals Plus Exercise|Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
10993780|NCT04087343|EG000|Reported Event|Meals Only|Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
10993781|NCT04087343|EG001|Reported Event|Meals Plus Exercise|Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
10993782|NCT03656107|BG000|Baseline|Cognitive Training|"Participants selected to brain training will be given instructions on how to access and use the program at home for 15-30minutes, 3-5 times per week for 8-12 weeks.~Cognitive Training: Lumosity© is a commercially available software, developed by a group of neuropsychologists, which has been used across several studies of brain training and disciplines. The brain training software targets multiple brain areas, is based online, and is relatively easy to use and administer. It has been designed to adapt to the individual's memory performance to personalise the training program to their needs. Brain exercises will be selected with the support of Lumosity© to target the following brain areas; attention, memory, visuospatial, verbal fluency, and language."
10993783|NCT03656107|BG001|Baseline|Waiting-list Control|Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
10993784|NCT03656107|BG002|Baseline|Total|Total of all reporting groups
11099070|NCT01579565|BG000|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
10876883|NCT00444457|EG002|Reported Event|Infant Series 13vPnC (Manufacturing Lot)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386."
10876884|NCT00444457|EG003|Reported Event|Infant Series 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198."
10876885|NCT00444457|EG004|Reported Event|After the Infant Series Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
10876886|NCT00444457|EG005|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
10876887|NCT00444457|EG006|Reported Event|Toddler Dose Combined 13vPnC|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771."
10876888|NCT00444457|EG007|Reported Event|Toddler Dose 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128."
10876889|NCT00444457|EG008|Reported Event|Post Toddler Dose 6-Month Follow-up Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
10876890|NCT00444457|EG009|Reported Event|Post Toddler Dose 6-Month Follow-up 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
10876891|NCT00444535|BG000|Baseline|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
10876892|NCT00444535|FG000|Participant Flow|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
10876893|NCT00444535|OG000|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
10876894|NCT00444535|EG000|Reported Event|Lapatinib + Bevacizumab|Lapatinib + Bevacizumab
10876895|NCT00444587|BG000|Baseline|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
10993785|NCT03656107|FG000|Participant Flow|Cognitive Training|"Participants selected to brain training will be given instructions on how to access and use the program at home for 15-30minutes, 3-5 times per week for 8-12 weeks.~Cognitive Training: Lumosity© is a commercially available software, developed by a group of neuropsychologists, which has been used across several studies of brain training and disciplines. The brain training software targets multiple brain areas, is based online, and is relatively easy to use and administer. It has been designed to adapt to the individual's memory performance to personalise the training program to their needs. Brain exercises will be selected with the support of Lumosity© to target the following brain areas; attention, memory, visuospatial, verbal fluency, and language."
10993786|NCT03656107|FG001|Participant Flow|Waiting-list Control|Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
11348233|NCT04195581|FG000|Participant Flow|All Participants|"Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months.~Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step)."
10993787|NCT03656107|OG000|Outcome|Cognitive Training|"Participants selected to brain training will be given instructions on how to access and use the program at home for 15-30minutes, 3-5 times per week for 8-12 weeks.~Cognitive Training: Lumosity© is a commercially available software, developed by a group of neuropsychologists, which has been used across several studies of brain training and disciplines. The brain training software targets multiple brain areas, is based online, and is relatively easy to use and administer. It has been designed to adapt to the individual's memory performance to personalise the training program to their needs. Brain exercises will be selected with the support of Lumosity© to target the following brain areas; attention, memory, visuospatial, verbal fluency, and language."
10993788|NCT03656107|OG001|Outcome|Waiting-list Control|Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
10993789|NCT03656107|EG000|Reported Event|Cognitive Training|"Participants selected to brain training will be given instructions on how to access and use the program at home for 15-30minutes, 3-5 times per week for 8-12 weeks.~Cognitive Training: Lumosity© is a commercially available software, developed by a group of neuropsychologists, which has been used across several studies of brain training and disciplines. The brain training software targets multiple brain areas, is based online, and is relatively easy to use and administer. It has been designed to adapt to the individual's memory performance to personalise the training program to their needs. Brain exercises will be selected with the support of Lumosity© to target the following brain areas; attention, memory, visuospatial, verbal fluency, and language."
10993790|NCT03656107|EG001|Reported Event|Waiting-list Control|Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
11007521|NCT01091246|FG000|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
11007522|NCT01091246|FG001|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
11007523|NCT01091246|FG002|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
11007524|NCT01091246|OG000|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
11007525|NCT01091246|OG001|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
11007526|NCT01091246|OG002|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
11007527|NCT01091246|OG003|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
11007528|NCT01091246|OG001|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
11348234|NCT04195581|OG000|Outcome|Comfilcon A With All in One Light Multi-purpose Solution|Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.
11348235|NCT04195581|OG001|Outcome|Comfilcon A With Hy-Care Multi-purpose Solution|Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.
10993791|NCT03554850|BG000|Baseline|Subject Demographics and Baseline Characteristics|Subjects' demographic characteristics will be summarized using descriptive statistic methods.- Continuous variables will be summarized by mean±SD, median, minimum and maximum. Categorical variables will be summarized by percentages and frequencies.
10993792|NCT03554850|FG000|Participant Flow|Single Arm-Trevo® Retriever|All subjects who meet the inclusion/exclusion criteria and where Trevo Retriever is used as the initial mechanical thrombectomy device to remove thrombus from the neurovasculature in the setting of acute ischemic stroke.
10993793|NCT03554850|OG000|Outcome|Primary Effectiveness Outcome|post-procedural eTICI score (≥2b)
10993794|NCT03554850|OG000|Outcome|Day 90 mRS Data|good clinical outcomes defined as mRS of 0-2.
10993795|NCT03554850|OG000|Outcome|Day 90 Mortality|If the subjects had completed their 90-day visit, the subjects will be considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death will be used to compare with the upper window of their Day 90 (90 + 14 days post procedure). If the subjects died after the upper window of their Day 90, the subjects will be considered as alive at their Day 90. Otherwise, the subjects will be counted as death before Day 90.
10993796|NCT03554850|OG000|Outcome|Neurological Deterioration|Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.
10993797|NCT03554850|OG000|Outcome|Rate of Study Device and Procedure Related SAE Through Day 90.|Rate of study device and procedure related serious adverse events (SAE) through Day 90.
10993798|NCT03554850|EG000|Reported Event|Overall Summary of All AEs and SAEs|"All SAEs through Day 90 will be summarized by number of events, number of subjects with events and the percentages of subjects with events by the type of SAEs and by their relatedness.~All AEs during procedure will be summarized by number of events, number of subjects with events and the percentages of the subjects with events by the type of AEs and by their relatedness."
10993799|NCT03426566|BG000|Baseline|Patients With Diabetes|"Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned.~retrospective observational study with no intervention: no intervention"
10993800|NCT03426566|FG000|Participant Flow|Patients With Diabetes|"Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned.~retrospective observational study with no intervention: no intervention"
10993801|NCT03426566|OG000|Outcome|Patients With Diabetes|Patients with diabetes from Diabetic Foot Centre
10993802|NCT03426566|OG000|Outcome|Patients With Diabetes|Patients with diabetes from Diabetes Foot Center (DFC)
10993803|NCT03426566|OG000|Outcome|Patients With Diabetes|Patients with diabetes from DFC
10993804|NCT03426566|EG000|Reported Event|Patients With Diabetes|"Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned.~retrospective observational study with no intervention: no intervention"
10993805|NCT03398356|BG000|Baseline|Group A|"Patients with pre-diabetes; metformin dose 3 x 500 mg~Metformin: for group A: 12 weeks metformin treatment with a final dose 3 x 500 mg, after 3 weeks of the titration Total treatment time: 15 weeks"
10993806|NCT03398356|BG001|Baseline|Group B|"Patients with pre-diabetes, max metformin dose 3 x 1000 mg~Metformin: for group B: 3 weeks metformin treatment with a dose 3 x 500 mg, after 3 weeks of the titration next: 3 weeks metformin treatment with a final dose 3 x 1000mg, after 3 weeks of the titration next: 3 weeks metformin treatment with a dose 3 x 500 mg. Total treatment time: 15 weeks"
10993807|NCT03398356|BG002|Baseline|Group C|healthy volunteers
10993808|NCT03398356|BG003|Baseline|Total|Total of all reporting groups
10993809|NCT03398356|FG000|Participant Flow|Group A|"metformin dose 3 x 500 mg~Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg~for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg."
10993810|NCT03398356|FG001|Participant Flow|Group B|"metformin dose 3 x 1000 mg~Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg~for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg."
10993811|NCT03398356|FG002|Participant Flow|Group C|control healthy volunteers, no intervention
10993812|NCT03398356|OG000|Outcome|Group A|"metformin dose 3 x 500 mg~Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg~for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg."
10993813|NCT03398356|OG001|Outcome|Group B|"metformin dose 3 x 1000 mg~Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg~for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg."
10993814|NCT03398356|OG002|Outcome|Group C|control healthy volunteers, no intervention
10993815|NCT03398356|EG000|Reported Event|Group A|"metformin dose 3 x 500 mg~Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg~for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg."
10993816|NCT03398356|EG001|Reported Event|Group B|"metformin dose 3 x 1000 mg~Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg~for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg."
10993817|NCT03398356|EG002|Reported Event|Group C|healthy volunteers, no intervention
11223308|NCT02352493|OG006|Outcome|ALN-CC5 600mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 600mg
11223309|NCT02352493|OG007|Outcome|ALN-CC5 900mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 900mg
11223310|NCT02352493|OG008|Outcome|ALN-CC5 100mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
11348236|NCT04195581|OG002|Outcome|Comfilcon A With Refine One Step Hydrogen Peroxide Solution|Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
10993818|NCT03365791|BG000|Baseline|PDR001+LAG525|PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001.
10993819|NCT03365791|FG000|Participant Flow|PDR001+LAG525|PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001.
10993820|NCT03365791|OG000|Outcome|PDR001+LAG525|PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001.
10993821|NCT03365791|EG000|Reported Event|PDR001+LAG525 On-treatment Period|PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001
10993822|NCT03365791|EG001|Reported Event|PDR001+LAG525 Extended Safety Follow-up Period|PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001
10993823|NCT03350750|BG000|Baseline|Open Shunt Group|"FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation~programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve"
10993824|NCT03350750|BG001|Baseline|Closed Shunt Group|"FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.~programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve"
10993825|NCT03350750|BG002|Baseline|Total|Total of all reporting groups
10993826|NCT03350750|FG000|Participant Flow|Open Shunt Group|"FDA-approved Certas Plus with Siphonguard, programmable cerebrospinal fluid (CSF) shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation~programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve"
10993827|NCT03350750|FG001|Participant Flow|Closed Shunt Group|"FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.~programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve"
10993828|NCT03350750|OG000|Outcome|Open Shunt Group|"FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation~programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve"
10993829|NCT03350750|OG001|Outcome|Closed Shunt Group|"FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.~programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve"
10993830|NCT03350750|OG000|Outcome|All Randomized Patients|All patients in the trial (arms combined for this evaluation). All randomized patients evaluated after 8 months of active shunting
10993831|NCT03350750|OG000|Outcome|All Randomized Patients|All patients in the trial (arms combined for this evaluation). All randomized patients evaluated after 8 months of active shunting.
10993832|NCT03350750|EG000|Reported Event|Open Shunt Group|"FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation~programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve"
10993833|NCT03350750|EG001|Reported Event|Closed Shunt Group|"FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.~programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve"
10993834|NCT03125148|BG000|Baseline|Enteral Stenting Intraduodenal|"Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction.~Enteral stenting: Enteral stent for malignant duodenal obstruction"
10993835|NCT03125148|BG001|Baseline|Enteral Stenting Transpyloric|"Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the stent bridging the obstruction and the pyloric opening with proximal end of the stent lying within the stomach~Enteral stenting: Enteral stent for malignant duodenal obstruction"
10993836|NCT03125148|BG002|Baseline|Total|Total of all reporting groups
10993837|NCT03125148|FG000|Participant Flow|Enteral Stenting Intraduodenal|"GROUP A: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction.~Enteral stenting: Enteral stent for malignant duodenal obstruction"
10993838|NCT03125148|FG001|Participant Flow|Enteral Stenting Transpyloric|"GROUP B: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the stent bridging the obstruction and the pyloric opening with proximal end of the stent lying within the stomach~Enteral stenting: Enteral stent for malignant duodenal obstruction"
10993839|NCT03125148|OG000|Outcome|Enteral Stenting Intraduodenal|"GROUP A: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction.~Enteral stenting: Enteral stent for malignant duodenal obstruction"
10993840|NCT03125148|OG001|Outcome|Enteral Stenting Transpyloric|"GROUP B: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the stent bridging the obstruction and the pyloric opening with proximal end of the stent lying within the stomach~Enteral stenting: Enteral stent for malignant duodenal obstruction"
10993841|NCT03125148|EG000|Reported Event|Enteral Stenting Intraduodenal|"GROUP A: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the entire stent lying within the duodenum bridging the obstruction.~Enteral stenting: Enteral stent for malignant duodenal obstruction"
11348237|NCT04195581|OG003|Outcome|Fanfilcon A With All in One Light Multi-purpose Solution|Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.
11348238|NCT04195581|OG004|Outcome|Fanfilcon A With Hy-Care Multi-purpose Solution|Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.
11223311|NCT02352493|OG009|Outcome|ALN-CC5 200mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
11223312|NCT02352493|OG010|Outcome|ALN-CC5 400mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
11223313|NCT02352493|OG011|Outcome|ALN-CC5 600mg Biweekly - Multiple Ascending Dose|Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
11223314|NCT02352493|OG012|Outcome|ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
11223315|NCT02352493|OG013|Outcome|ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
11223316|NCT02352493|OG014|Outcome|ALN-CC5 Multiple Dose - Eculizumab Treated|Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
11223317|NCT02352493|OG015|Outcome|ALN-CC5 Multiple Dose - Eculizumab Naive|Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
11223318|NCT02352493|OG015|Outcome|ALN-CC5 Multiple Dose - Eculizumab Naive|Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses.
11223319|NCT02352493|EG000|Reported Event|Placebo - Single Ascending Dose|Healthy volunteers received a single dose of placebo (normal saline)
11223320|NCT02352493|EG001|Reported Event|ALN-CC5 50mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 50mg
11223321|NCT02352493|EG002|Reported Event|ALN-CC5 50mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 50mg
11223322|NCT02352493|EG003|Reported Event|ALN-CC5 200mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 200mg
11223323|NCT02352493|EG004|Reported Event|ALN-CC5 200mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 200mg
11223324|NCT02352493|EG005|Reported Event|ALN-CC5 400mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 400mg
11223325|NCT02352493|EG006|Reported Event|ALN-CC5 600mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 600mg
11223326|NCT02352493|EG007|Reported Event|ALN-CC5 600mg (Japanese) - Single Ascending Dose|Japanese healthy volunteers received a single dose of ALN-CC5 600mg
11223327|NCT02352493|EG008|Reported Event|ALN-CC5 900mg - Single Ascending Dose|Healthy volunteers received a single dose of ALN-CC5 900mg
11223328|NCT02352493|EG009|Reported Event|Placebo - Multiple Ascending Dose|Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
11223329|NCT02352493|EG010|Reported Event|ALN-CC5 100mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
11223330|NCT02352493|EG011|Reported Event|ALN-CC5 200mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
11223331|NCT02352493|EG012|Reported Event|ALN-CC5 400mg Weekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
11223332|NCT02352493|EG013|Reported Event|ALN-CC5 600mg Biweekly - Multiple Ascending Dose|Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
11223333|NCT02352493|EG014|Reported Event|ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
11223334|NCT02352493|EG015|Reported Event|ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose|Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
11223335|NCT02352493|EG016|Reported Event|ALN-CC5 Multiple Dose - Eculizumab Treated|Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
11223336|NCT02352493|EG017|Reported Event|ALN-CC5 Multiple Dose - Eculizumab Naive|Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
11223337|NCT02352779|BG000|Baseline|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223338|NCT02352779|BG001|Baseline|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223339|NCT02352779|BG002|Baseline|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223340|NCT02352779|BG003|Baseline|Total|Total of all reporting groups
11223341|NCT02352779|FG000|Participant Flow|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223342|NCT02352779|FG001|Participant Flow|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223343|NCT02352779|FG002|Participant Flow|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223344|NCT02352779|OG000|Outcome|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223345|NCT02352779|OG001|Outcome|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223346|NCT02352779|OG002|Outcome|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223347|NCT02352779|EG000|Reported Event|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223348|NCT02352779|EG001|Reported Event|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223349|NCT02352779|EG002|Reported Event|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11223350|NCT02352831|BG000|Baseline|Phase I (Tosedostat + Capecitabine)|"The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.~Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.~Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
11223351|NCT02352831|BG001|Baseline|Phase II (Tosedostat + Capecitabine)|"Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle~Capecitabine by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
10993842|NCT03125148|EG001|Reported Event|Enteral Stenting Transpyloric|"GROUP B: Enteral stent (Wallflex enteral stent) will be placed in the duodenum with the stent bridging the obstruction and the pyloric opening with proximal end of the stent lying within the stomach~Enteral stenting: Enteral stent for malignant duodenal obstruction"
11007529|NCT01091246|OG001|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
11223352|NCT02352831|BG002|Baseline|Total|Total of all reporting groups
11223353|NCT02352831|FG000|Participant Flow|Phase I (Tosedostat + Capecitabine)|"The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.~Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.~Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
11223354|NCT02352831|FG001|Participant Flow|Phase II (Tosedostat + Capecitabine)|"Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle~Capecitabine by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
11223355|NCT02352831|OG000|Outcome|Phase I (Tosedostat + Capecitabine)|"The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.~Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.~Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
11223356|NCT02352831|OG001|Outcome|Phase II (Tosedostat + Capecitabine)|"Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle~Capecitabine by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
11223357|NCT02352831|OG002|Outcome|Phase I and Phase II Combined|"Tosedostat by mouth daily Days 1-21 of each 21-day cycle~Capecitabine by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
11223358|NCT02352831|OG002|Outcome|Phase I and Phase II (Tosedostat + Capecitabine)|"Tosedostat by mouth daily Days 1-21 of each 21-day cycle~Capecitabine by mouth BID Days 1-14 of each 21-day cycle"
11223359|NCT02352831|EG000|Reported Event|Phase I (Tosedostat + Capecitabine)|"The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.~Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.~Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
11223360|NCT02352831|EG001|Reported Event|Phase II (Tosedostat + Capecitabine)|"Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle~Capecitabine by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain."
10993843|NCT02819440|BG000|Baseline|Tadalafil|"Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the Tadalafil arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of Tadalafil (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the active comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).~Tadalafil: Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit."
10993844|NCT02819440|BG001|Baseline|Placebo|"Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the placebo arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of a placebo pill (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the placebo comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).~Placebo: 100 patients will be randomized to receive a placebo pill. Subjects in this arm will be provided with 20mg Placebo to take every day for 12 weeks, beginning at their baseline visit."
10993845|NCT02819440|BG002|Baseline|Total|Total of all reporting groups
10993846|NCT02819440|FG000|Participant Flow|Tadalafil|"Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the Tadalafil arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of Tadalafil (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the active comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).~Tadalafil: Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit."
10993847|NCT02819440|FG001|Participant Flow|Placebo|"Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the placebo arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of a placebo pill (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the placebo comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).~Placebo: 100 patients will be randomized to receive a placebo pill. Subjects in this arm will be provided with 20mg Placebo to take every day for 12 weeks, beginning at their baseline visit."
10993848|NCT02819440|OG000|Outcome|Tadalafil|"Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the Tadalafil arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of Tadalafil (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the active comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).~Tadalafil: Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit."
10993849|NCT02819440|OG001|Outcome|Placebo|"Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the placebo arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of a placebo pill (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the placebo comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).~Placebo: 100 patients will be randomized to receive a placebo pill. Subjects in this arm will be provided with 20mg Placebo to take every day for 12 weeks, beginning at their baseline visit."
10993850|NCT02819440|EG000|Reported Event|Tadalafil|"Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the Tadalafil arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of Tadalafil (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the active comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).~Tadalafil: Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit."
10993851|NCT02819440|EG001|Reported Event|Placebo|"Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the placebo arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of a placebo pill (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the placebo comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).~Placebo: 100 patients will be randomized to receive a placebo pill. Subjects in this arm will be provided with 20mg Placebo to take every day for 12 weeks, beginning at their baseline visit."
10993852|NCT02782741|BG000|Baseline|Avalglucosidase Alfa|Avalglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in blinded treatment period (also known as PAP); followed by same treatment from Week 50 to 145 in an open-label avalglucosidase alfa long-term follow-up phase.
10993853|NCT02782741|BG001|Baseline|Alglucosidase Alfa in PAP Then Avalglucosidase Alfa in Open-label|Alglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in blinded treatment period (also known as PAP); followed by avalglucosidase alfa 20 mg/kg IV infusion q2w treatment from Week 50 to 145 in an open-label avalglucosidase alfa long-term follow-up phase.
10993854|NCT02782741|BG002|Baseline|Total|Total of all reporting groups
11223361|NCT02352844|BG000|Baseline|Arm 1 (Everolimus)|Everolimus is an oral drug which will be administered on an outpatient basis at a dose of 10 mg daily on a 28-day cycle.
10993855|NCT02782741|FG000|Participant Flow|Avalglucosidase Alfa|Avalglucosidase alfa, 20 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (q2w) up to Week 49 in blinded treatment period (also known as primary analysis period [PAP]); followed by same treatment from Week 50 to 145 in an open-label avalglucosidase alfa long-term follow-up phase.
10993856|NCT02782741|FG001|Participant Flow|Alglucosidase Alfa in PAP Then Avalglucosidase Alfa in Open-label|Alglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in blinded treatment period (also known as PAP); followed by avalglucosidase alfa 20 mg/kg IV infusion q2w treatment from Week 50 to 145 in an open-label avalglucosidase alfa long-term follow-up phase.
10993857|NCT02782741|OG000|Outcome|PAP: Avalglucosidase Alfa|Avalglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in blinded treatment period (also known as PAP).
10993858|NCT02782741|OG001|Outcome|PAP: Alglucosidase Alfa|Alglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in blinded treatment period (also known as PAP).
10993859|NCT02782741|OG000|Outcome|Avalglucosidase Alfa|Included all participants who received avalglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in PAP; followed the same treatment from Week 50 to 145 in an open-label avalglucosidase alfa long-term follow-up phase.
10993860|NCT02782741|OG001|Outcome|Alglucosidase Alfa in PAP Then Avalglucosidase Alfa in Open-label|Included all participants who received alglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in PAP; followed by avalglucosidase alfa 20 mg/kg IV infusion q2w treatment from Week 50 to 145 in an open-label avalglucosidase alfa long-term follow-up phase.
10993861|NCT02782741|EG000|Reported Event|PAP: Avalglucosidase Alfa|Avalglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in blinded treatment period (also known as PAP).
10993862|NCT02782741|EG001|Reported Event|PAP: Alglucosidase Alfa|Alglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in blinded treatment period (also known as PAP).
10993863|NCT02782741|EG002|Reported Event|Open-label Period: Avalglucosidase Alfa|Included all participants who received avalglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in PAP followed by same treatment from Week 50 to 145 in an open-label avalglucosidase alfa long-term follow-up phase.
10993864|NCT02782741|EG003|Reported Event|Open-label Period: Alglucosidase Alfa in PAP Then Avalglucosidase Alfa in Open-label|Included all participants who received alglucosidase alfa, 20 mg/kg IV infusion q2w up to Week 49 in PAP; followed by avalglucosidase alfa 20 mg/kg IV infusion q2w treatment from Week 50 to 145 in an open-label avalglucosidase alfa long-term follow-up phase.
10993874|NCT02647359|BG000|Baseline|Ataluren|Participants received ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period) and for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks.
10993875|NCT02647359|BG001|Baseline|Placebo|Participants received placebo matched to ataluren TID orally in the morning, at midday, and in the evening for 48 weeks in Stage 1 (double-masked period) and ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks.
10993876|NCT02647359|BG002|Baseline|Total|Total of all reporting groups
10993877|NCT02647359|FG000|Participant Flow|Ataluren|Participants received ataluren orally 3 times a day (TID) at a dose of 10 milligrams (mg)/kilogram (kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period) and for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks.
11223362|NCT02352844|FG000|Participant Flow|Arm 1 (Everolimus)|Everolimus is an oral drug which will be administered on an outpatient basis at a dose of 10 mg daily on a 28-day cycle.
10876896|NCT00444587|BG001|Baseline|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator's decision.
10876897|NCT00444587|BG002|Baseline|Total|Total of all reporting groups
10876898|NCT00444587|FG000|Participant Flow|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab (Herceptin) 6 milligrams per kilograms (mg/kg) of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous (IV) infusion every three weeks until disease progression, unacceptable toxicities, or withdrawal from study, in combination with second line chemotherapy.
10876899|NCT00444587|FG001|Participant Flow|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator's decision.
10876900|NCT00444587|OG000|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
10876901|NCT00444587|OG000|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
10876902|NCT00444587|OG001|Outcome|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator's decision.
10876903|NCT00444587|OG001|Outcome|Only Chemotherapy|Eligible participants received second line chemotherapy according to the investigator's decision.
10876904|NCT00444587|EG000|Reported Event|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
10876905|NCT00444587|EG001|Reported Event|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator's decision.
10876906|NCT00444600|BG000|Baseline|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876907|NCT00444600|BG001|Baseline|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876908|NCT00444600|BG002|Baseline|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
10876909|NCT00444600|BG003|Baseline|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876910|NCT00444600|BG004|Baseline|Total|Total of all reporting groups
10876911|NCT00444600|FG000|Participant Flow|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876912|NCT00444600|FG001|Participant Flow|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876913|NCT00444600|FG002|Participant Flow|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
10876914|NCT00444600|FG003|Participant Flow|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876915|NCT00444600|OG000|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876916|NCT00444600|OG001|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876917|NCT00444600|OG002|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
10876918|NCT00444600|OG003|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
10876919|NCT00444600|OG000|Outcome|Sham|
10876920|NCT00444600|OG001|Outcome|Ranibizumab|
10876921|NCT00444600|OG002|Outcome|Triamcinolone|
10876922|NCT00444600|EG000|Reported Event|Sham + Prompt Laser|Laser was given within 3 to 10 days after sham injections, Laser = Focal/grid photocoagulation
10876923|NCT00444600|EG001|Reported Event|Ranibizumab + Prompt Laser|0.5 mg intravitreal ranibizumab plus prompt (within 3-10 days after injection) focal/grid photocoagulation
10876924|NCT00444600|EG002|Reported Event|Ranibizumab + Deferred Laser|0.5 mg intravitreal ranibizumab with deferred (24 weeks) focal/grid photocoagulation
10876925|NCT00444600|EG003|Reported Event|Triamcinolone + Prompt Laser|4 mg intravitreal triamcinolone plus prompt (within 3-10 days after injection) focal/grid photocoagulation
10993878|NCT02647359|FG001|Participant Flow|Placebo|Participants received placebo matched to ataluren TID orally in the morning, at midday, and in the evening for 48 weeks in Stage 1 (double-masked period) and ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks.
10993879|NCT02647359|OG000|Outcome|Ataluren|Participants received ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period) and for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks.
10993880|NCT02647359|OG001|Outcome|Placebo|Participants received placebo matched to ataluren TID orally in the morning, at midday, and in the evening for 48 weeks in Stage 1 (double-masked period) and ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks.
10993881|NCT02647359|OG000|Outcome|Stage 1: Ataluren|Participants received ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period).
10993882|NCT02647359|OG001|Outcome|Stage 1: Placebo|Participants received placebo matched to ataluren TID orally in the morning, at midday, and in the evening for 48 weeks in Stage 1 (double-masked period).
10993883|NCT02647359|OG002|Outcome|Overall Ataluren Exposure|Participants received ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period) and for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks.
10993884|NCT02647359|EG000|Reported Event|Stage 1: Ataluren|Participants received ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period).
10993885|NCT02647359|EG001|Reported Event|Stage 1: Placebo|Participants received placebo matched to ataluren TID orally in the morning, at midday, and in the evening for 48 weeks in Stage 1 (double-masked period).
10993886|NCT02647359|EG002|Reported Event|Overall Ataluren Exposure|Participants received ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period) and for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks.
10993887|NCT02485691|BG000|Baseline|Cabazitaxel|Participants received Cabazitaxel 25 mg/m^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
10993888|NCT02485691|BG001|Baseline|Abiraterone Acetate or Enzalutamide|Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
10993889|NCT02485691|BG002|Baseline|Total|Total of all reporting groups
10993890|NCT02485691|FG000|Participant Flow|Cabazitaxel|Participants received Cabazitaxel 25 mg/m^2 intravenous (IV) infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic granulocyte-colony stimulating factor (G-CSF) as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
10993891|NCT02485691|FG001|Participant Flow|Abiraterone Acetate or Enzalutamide|Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration =12.5 weeks)
10993892|NCT02485691|OG000|Outcome|Cabazitaxel|Participants received Cabazitaxel 25 mg/m^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
10993893|NCT02485691|OG001|Outcome|Abiraterone Acetate or Enzalutamide|Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
10993894|NCT02485691|OG001|Outcome|Abiraterone Acetate or Enzalutamide|Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks)
10993895|NCT02485691|EG000|Reported Event|Cabazitaxel|Participants received Cabazitaxel 25 mg/m^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
11223363|NCT02352844|OG000|Outcome|Arm 1 (Everolimus)|Everolimus is an oral drug which will be administered on an outpatient basis at a dose of 10 mg daily on a 28-day cycle.
11223364|NCT02352844|EG000|Reported Event|Arm 1 (Everolimus)|Everolimus is an oral drug which will be administered on an outpatient basis at a dose of 10 mg daily on a 28-day cycle.
11223365|NCT02352922|BG000|Baseline|Liposomal Bupivacaine|"extended-release bupivacaine (EXPAREL)~Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine"
11223366|NCT02352922|BG001|Baseline|Bupivacaine HCl|"short-acting bupivacaine~Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl"
10876926|NCT00444600|EG004|Reported Event|Sham + Ranibizumab + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
10876927|NCT00444600|EG005|Reported Event|Sham + Ranibizumab + Deferred Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
10876928|NCT00444600|EG006|Reported Event|Sham + Triamcinolone + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
10876929|NCT00444626|BG000|Baseline|Combined Arms|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
10876930|NCT00444626|FG000|Participant Flow|Combined Arm|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
10876931|NCT00444626|OG000|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
10876932|NCT00444626|OG001|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
10876933|NCT00444626|OG000|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
10876934|NCT00444626|OG002|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
10876935|NCT00444626|OG001|Outcome|Restylane - Dermal Gel Extra (DGE)|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. In the Repeat Treatment Period, participants received DGE on both sides of their face. This represents the experience with DGE for the side of the face that was originally treated with Restylane.
10876936|NCT00444626|EG000|Reported Event|Dermal Gel Extra (DGE): Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment.
11223367|NCT02352922|BG002|Baseline|Total|Total of all reporting groups
11223368|NCT02352922|FG000|Participant Flow|Liposomal Bupivacaine|"extended-release bupivacaine (EXPAREL)~Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine"
11223369|NCT02352922|FG001|Participant Flow|Bupivacaine HCl|"short-acting bupivacaine~Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl"
11223370|NCT02352922|OG000|Outcome|Liposomal Bupivacaine|"extended-release bupivacaine (EXPAREL)~Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine"
11223371|NCT02352922|OG001|Outcome|Bupivacaine HCl|"short-acting bupivacaine~Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl"
11223372|NCT02352922|EG000|Reported Event|Liposomal Bupivacaine|"extended-release bupivacaine (EXPAREL)~Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine"
11223373|NCT02352922|EG001|Reported Event|Bupivacaine HCl|"short-acting bupivacaine~Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl"
11223374|NCT02352974|BG000|Baseline|GAD-Alum+Vitamin D|"GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals~Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days~GAD-Alum~Vitamin D"
11223375|NCT02352974|FG000|Participant Flow|GAD-Alum+Vitamin D|"GAD(Glutamic acid decarboxylase)-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals~Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days~GAD-Alum~Vitamin D"
11223376|NCT02352974|OG000|Outcome|GAD-Alum+Vitamin D|"GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals~Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days~GAD-Alum~Vitamin D"
10993896|NCT02485691|EG001|Reported Event|Enzalutamide or Abiraterone|Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
10993897|NCT02201251|BG000|Baseline|Topiramate|Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
10993898|NCT02201251|BG001|Baseline|Levetiracetam|Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
10993899|NCT02201251|BG002|Baseline|Total|Total of all reporting groups
10993900|NCT02201251|FG000|Participant Flow|Topiramate|Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
10993901|NCT02201251|FG001|Participant Flow|Levetiracetam|Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
10993902|NCT02201251|OG000|Outcome|Topiramate|Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
10993903|NCT02201251|OG001|Outcome|Levetiracetam|Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
10993904|NCT02201251|EG000|Reported Event|Topiramate|Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
10993905|NCT02201251|EG001|Reported Event|Levetiracetam|Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
11007530|NCT01091246|EG000|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
11007531|NCT01091246|EG001|Reported Event|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
11007532|NCT01091259|BG000|Baseline|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.~Irinotecan~Bevacizumab"
11007533|NCT01091259|FG000|Participant Flow|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.~Irinotecan~Bevacizumab"
11223377|NCT02352974|EG000|Reported Event|GAD-Alum+Vitamin D|"GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals~Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days~GAD-Alum~Vitamin D"
10993906|NCT02000596|BG000|Baseline|Cohort 1: T+P|"Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)~Trastuzumab plus Pertuzumab"
10993907|NCT02000596|BG001|Baseline|Cohort 2 - Arm A|"Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +~Trastuzumab plus Pertuzumab~Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days"
10993908|NCT02000596|BG002|Baseline|Cohort 2 - Arm B|"Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -~Trastuzumab plus Pertuzumab~Chemotherapy with Eribulin"
10993909|NCT02000596|BG003|Baseline|Total|Total of all reporting groups
10993910|NCT02000596|FG000|Participant Flow|Cohort 1: T+P|"Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)~Trastuzumab plus Pertuzumab"
10993911|NCT02000596|FG001|Participant Flow|Cohort 2 - Arm A|"Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +~Trastuzumab plus Pertuzumab~Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days"
10993912|NCT02000596|FG002|Participant Flow|Cohort 2 - Arm B|"Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -~Trastuzumab plus Pertuzumab~Chemotherapy with Eribulin"
10993913|NCT02000596|OG000|Outcome|Cohort 1: T+P|"Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)~Trastuzumab plus Pertuzumab"
10993914|NCT02000596|OG001|Outcome|Cohort 2 - Arm A|"Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +~Trastuzumab plus Pertuzumab~Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days"
10993915|NCT02000596|OG002|Outcome|Cohort 2 - Arm B|"Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -~Trastuzumab plus Pertuzumab~Chemotherapy with Eribulin"
10993916|NCT02000596|EG000|Reported Event|Cohort 1: T+P|"Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)~Trastuzumab plus Pertuzumab"
10993917|NCT02000596|EG001|Reported Event|Cohort 2 - Arm A|"Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +~Trastuzumab plus Pertuzumab~Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days"
10993918|NCT02000596|EG002|Reported Event|Cohort 2 - Arm B|"Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -~Trastuzumab plus Pertuzumab~Chemotherapy with Eribulin"
10993919|NCT00929253|BG000|Baseline|Computer Delivered CRA + CM + Suboxone|"In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for homework worksheets are provided. These participants receive vouchers for providing drug negative urine samples.~Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks~CRA: Computer-delivered Community Reinforcement Approach"
10993920|NCT00929253|BG001|Baseline|CM + Suboxone|"In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer deliver therapy, only treatment as usual consisting of biweekly 30-minute counseling sessions.~Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks~Therapy: treatment as usual~CM: Contingency management (vouchers) for providing a drug negative urine sample."
10993921|NCT00929253|BG002|Baseline|Total|Total of all reporting groups
10993922|NCT00929253|FG000|Participant Flow|Computer Delivered CRA + CM + Suboxone|"In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for homework worksheets are provided. These participants receive vouchers for providing drug negative urine samples.~Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks~CRA: Computer-delivered Community Reinforcement Approach"
10993923|NCT00929253|FG001|Participant Flow|CM + Suboxone|"In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer delivered CRA, only treatment as usual with a biweekly 30-minute meeting with a clinician.~Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks~Therapy: treatment as usual~CM: Contingency management (vouchers) for providing drug negative urine samples."
11007534|NCT01091259|OG000|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
11007535|NCT01091259|EG000|Reported Event|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
11223378|NCT02353091|BG000|Baseline|APD Control Group|Comprised 13 children diagnosed with APD and rdid not receive an intervention.
10993924|NCT00929253|OG000|Outcome|Computer Delivered CRA + CM + Suboxone|"In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for homework worksheets are provided. These participants receive vouchers for providing drug negative urine samples.~Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks~CRA: Computer-delivered Community Reinforcement Approach"
10993925|NCT00929253|OG001|Outcome|CM + Suboxone|"In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer deliver therapy.~Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks~Therapy: Therapist-delivered therapy~CM: Contingency management (vouchers) for providing a drug negative urine sample."
10993926|NCT00929253|EG000|Reported Event|Computer Delivered CRA + CM + Suboxone|"In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for homework worksheets are provided. These participants receive vouchers for providing drug negative urine samples.~Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks~CRA: Computer-delivered Community Reinforcement Approach"
10993927|NCT00929253|EG001|Reported Event|CM + Suboxone|"In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer delivered CRA, only treatment as usual with a biweekly 30-minute meeting with a clinician.~Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks~Therapy: treatment as usual~CM: Contingency management (vouchers) for providing drug negative urine samples."
10993928|NCT00657241|BG000|Baseline|ARB First|Lisinopril 40 mg daily plus valsartan 160 mg daily (one week) then valsartan 320 mg daily (3 weeks) followed by lisinopril 40 mg daily plus carvedilol CR 20 mg daily (1 week) then carvedilol CR 40 mg daily (3 weeks)
10993929|NCT00657241|BG001|Baseline|Beta-blocker First|Lisinopril 40 mg daily plus carvedilol CR 20 mg daily (1 week) then carvedilol CR 40 mg daily (3 weeks) followed by lisinopril 40 mg daily plus valsartan 160 mg daily (one week) then valsartan 320 mg daily (3 weeks)
10993930|NCT00657241|BG002|Baseline|Total|Total of all reporting groups
10993931|NCT00657241|FG000|Participant Flow|ARB First|Lisinopril 40 mg daily plus valsartan 160 mg daily (one week) then valsartan 320 mg daily (3 weeks) followed by lisinopril 40 mg daily plus carvedilol CR 20 mg daily (one week) then carvedilol CR 40 mg daily (3 weeks)
10993932|NCT00657241|FG001|Participant Flow|Beta-blocker First|Lisinopril 40 mg daily plus carvedilol CR 20 mg (one week) and carvedilol CR 40 mg (3 weeks) followed by lisinopril 40 mg daily plus valsartan 160 mg daily (one week) and valsartan 320 mg daily (3 weeks).
11223379|NCT02353091|BG001|Baseline|APD Intervention Group|Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
11223380|NCT02353091|BG002|Baseline|Total|Total of all reporting groups
11223381|NCT02353091|FG000|Participant Flow|APD Control Group|Comprised 13 children diagnosed with APD and did not receive an intervention.
10993933|NCT00657241|OG000|Outcome|Carvedilol CR|Lisinopril 40 mg daily plus carvedilol CR 20 mg (one week) then carvedilol CR 40 mg (3 weeks) administered first or second
10993934|NCT00657241|OG001|Outcome|Valsartan|lisinopril 40 mg daily plus valsartan 160 mg daily (1 week) then valsartan 320 mg daily (3 weeks) administered first or second
10993935|NCT00657241|OG000|Outcome|Lisinopril Plus Valsartan|Lisinopril 40 mg daily plus valsartan 160 mg daily (one week) followed by lisinopril 40 mg daily plus valsartan 320 mg (3 weeks)
10993936|NCT00657241|OG001|Outcome|Lisinopril Plus Carvedilol|Lisinopril 40 mg daily plus carvedilol CR 20 mg (one week) followed by lisinopril 40 mg daily plus carvedilol CR 40 mg (3 weeks).
10993937|NCT00657241|OG000|Outcome|Lisinopril Plus Valsartan|Lisinopril 40 mg daily plus valsartan 160 mg daily (one week)followed by lisinopril 40 mg daily plus valsartan 320 mg (3 weeks)
10993938|NCT00657241|OG001|Outcome|Lisinopril Plus Carvedilol|Lisinopril 40 mg daily plus Coreg CR 20 mg (one week) followed by lisinopril 40 mg daily plus Coreg CR 40 mg (3 weeks).
10993939|NCT00657241|EG000|Reported Event|Valsartan|Lisinopril 40 mg daily plus valsartan 160 mg daily (one week) then valsartan 320 mg daily (3 weeks)
10993940|NCT00657241|EG001|Reported Event|Carvedilol CR|Lisinopril 40 mg daily plus carvedilol CR 20 mg daily (one week) then carvedilol CR 40 mg daily (3 weeks).
11223382|NCT02353091|FG001|Participant Flow|APD Intervention Group|Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
11223383|NCT02353091|OG000|Outcome|APD Control Group|Comprised of 13 children diagnosed with APD and does not receive any intervention.
11223384|NCT02353091|OG001|Outcome|APD Intervention Group|Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
11223385|NCT02353091|OG000|Outcome|APD Control Group|Comprised of 13 children diagnosed with APD and did not receive any intervention.
11223386|NCT02353091|OG000|Outcome|APD Control Group|Comprised 13 children diagnosed with APD and did not receive any intervention.
11223387|NCT02353091|OG001|Outcome|APD Intervention Group|Comprised 13 children diagnosed with APD and received a Remotre Microphone Hearing Aid intervention after baseline testing and for 6 months.
10993941|NCT01021293|BG000|Baseline|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
10993942|NCT01021293|BG001|Baseline|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
11223388|NCT02353091|OG000|Outcome|APD Control Group|Comprised 13 children diagnosed with APD that did not receive any intervention.
11223389|NCT02353091|OG001|Outcome|APD Intervention Group|Comprised 13 children diagnosed with APD that received the Remote Microphone Hearing Aid intervention after baseline testing and used for 6 months.
10993943|NCT01021293|BG002|Baseline|Total|Total of all reporting groups
10993944|NCT01021293|FG000|Participant Flow|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
10993945|NCT01021293|FG001|Participant Flow|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
10993946|NCT01021293|OG000|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
10993947|NCT01021293|OG001|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
10993948|NCT01021293|OG001|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) vaccine at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
10993949|NCT01021293|EG000|Reported Event|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
10993950|NCT01021293|EG001|Reported Event|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
11223390|NCT02353091|OG000|Outcome|APD Group 1|"APD Group 1 is comprised of 13 children diagnosed with APD and receives the device from the beginning of the study.~Personal FM system"
11223391|NCT02353091|OG001|Outcome|APD Group 2|"APD Group 2 is comprised of 13 children diagnosed with APD and receives the device 6 months later than APD Group 1.~Personal FM system"
11223392|NCT02353091|OG000|Outcome|APD Group 1|"APD Group 1 is comprised 13 children diagnosed with APD and acts as a control without using any form of intervention.~No intervention: No intervention is assigned"
10993951|NCT01021306|BG000|Baseline|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
10993952|NCT01021306|BG001|Baseline|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
10993953|NCT01021306|BG002|Baseline|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
11223393|NCT02353091|OG001|Outcome|APD Group 2|"APD Group 2 is comprised 13 children diagnosed with APD and receives the intervention at the start of the study.~Remote Microphone Hearing Aids: The ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m."
11223394|NCT02353091|EG000|Reported Event|APD Control Group|Comprised 13 children diagnosed with APD and did not receive any intervention.
11223395|NCT02353091|EG001|Reported Event|APD Intervention Group|Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
10993954|NCT01021306|BG003|Baseline|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
10993955|NCT01021306|BG004|Baseline|Total|Total of all reporting groups
10993956|NCT01021306|FG000|Participant Flow|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
10993957|NCT01021306|FG001|Participant Flow|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
10993958|NCT01021306|FG002|Participant Flow|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
10993959|NCT01021306|FG003|Participant Flow|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
10993960|NCT01021306|OG000|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
10993961|NCT01021306|OG001|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
10993962|NCT01021306|OG002|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
11007536|NCT01091363|BG000|Baseline|Deep Cultural|"eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT~nicotine patch: 8-week nicotine patch therapy"
11348239|NCT04195581|OG005|Outcome|Fanfilcon A With Refine One Step Hydrogen Peroxide Solution|Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
11348240|NCT04195581|OG003|Outcome|Fanfilcon A With All in One Light Multi-purpose Solution|Subject were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.
11348241|NCT04195581|OG004|Outcome|Fanfilcon A With Hy-Care Multi-purpose Solution|Subject were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.
11223396|NCT02353169|BG000|Baseline|Dexmedetomidine 0.25mcg/kg|"0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11223397|NCT02353169|BG001|Baseline|Dexmedetomidine 0.5mcg/kg|"0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11223398|NCT02353169|BG002|Baseline|Dexmedetomidine 0.75mcg/kg|"0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11223399|NCT02353169|BG003|Baseline|Saline Bolus|"10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~normal saline solution"
11223400|NCT02353169|BG004|Baseline|Total|Total of all reporting groups
10876937|NCT00444626|EG001|Reported Event|Restylane: Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment.
10876938|NCT00444626|EG002|Reported Event|Non-NLF: Initial Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment.
10876939|NCT00444626|EG003|Reported Event|Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
10876940|NCT00444626|EG004|Reported Event|Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
10876941|NCT00444626|EG005|Reported Event|Non-NLF: Repeat Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment.
10876942|NCT00444678|BG000|Baseline|Cetuximab, Capecitabine and Oxaliplatin|"Cetuximab: 500 mg/m2, IV every two weeks~Oxaliplatin: 85 mg/m2, IV, q 2 weeks~Capecitabine: 2500 mg, po bid x 7 days every two weeks"
10876943|NCT00444678|FG000|Participant Flow|Cetuximab, Capecitabine and Oxaliplatin|"Cetuximab: 500 mg/m2, IV every two weeks~Oxaliplatin: 85 mg/m2, IV, q 2 weeks~Capecitabine: 2500 mg, po bid x 7 days every two weeks"
10876944|NCT00444678|OG000|Outcome|Cetuximab, Capecitabine and Oxaliplatin|"Cetuximab: 500 mg/m2, IV every two weeks~Oxaliplatin: 85 mg/m2, IV, q 2 weeks~Capecitabine: 2500 mg, po bid x 7 days every two weeks"
10876945|NCT00444678|EG000|Reported Event|Cetuximab, Capecitabine and Oxaliplatin|"Cetuximab: 500 mg/m2, IV every two weeks~Oxaliplatin: 85 mg/m2, IV, q 2 weeks~Capecitabine: 2500 mg, po bid x 7 days every two weeks"
10876946|NCT00444795|BG000|Baseline|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10876947|NCT00444795|FG000|Participant Flow|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10876948|NCT00444795|OG000|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10876949|NCT00444795|EG000|Reported Event|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10876950|NCT00444821|BG000|Baseline|Surveillance|Subjects were assigned to serial ultrasound surveillance
10876951|NCT00444821|BG001|Baseline|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
10876952|NCT00444821|BG002|Baseline|Total|Total of all reporting groups
10876953|NCT00444821|FG000|Participant Flow|Surveillance|Subjects were assigned to serial ultrasound surveillance
10876954|NCT00444821|FG001|Participant Flow|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
10876955|NCT00444821|OG000|Outcome|Surveillance|Subjects were assigned to serial ultrasound surveillance
10876956|NCT00444821|OG001|Outcome|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
10876957|NCT00444821|EG000|Reported Event|Surveillance|Subjects were assigned to serial ultrasound surveillance
10876958|NCT00444821|EG001|Reported Event|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
10876959|NCT00444912|BG000|Baseline|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
10876960|NCT00444912|BG001|Baseline|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
10876961|NCT00444912|BG002|Baseline|Total|Total of all reporting groups
10876962|NCT00444912|FG000|Participant Flow|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
10876963|NCT00444912|FG001|Participant Flow|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
11223401|NCT02353169|FG000|Participant Flow|Dexmedetomidine 0.25mcg/kg|"0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11223402|NCT02353169|FG001|Participant Flow|Dexmedetomidine 0.5mcg/kg|"0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11348242|NCT04195581|OG001|Outcome|Comfilcon A With Hy-Care Multi-purpose Solution|Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month..
10876964|NCT00444912|OG000|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
10876965|NCT00444912|OG001|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
10876966|NCT00444912|EG000|Reported Event|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
10876967|NCT00444912|EG001|Reported Event|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
10876968|NCT00444925|BG000|Baseline|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
10876969|NCT00444925|BG001|Baseline|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
10876970|NCT00444925|BG002|Baseline|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
10876971|NCT00444925|BG003|Baseline|Total|Total of all reporting groups
10876972|NCT00444925|FG000|Participant Flow|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
10876973|NCT00444925|FG001|Participant Flow|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
10876974|NCT00444925|FG002|Participant Flow|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
10876975|NCT00444925|OG000|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
10876976|NCT00444925|OG001|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
10876977|NCT00444925|OG002|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
10876978|NCT00444925|EG000|Reported Event|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
10876979|NCT00444925|EG001|Reported Event|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
10876980|NCT00444925|EG002|Reported Event|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
10876981|NCT00444951|BG000|Baseline|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
11348243|NCT04195581|OG000|Outcome|Comfilcon A With All in One Light Multi-purpose Solution|Subjects were randomized to wear comfilcon A with All in One Light Multipurpose solution for a month.
10876982|NCT00444951|BG001|Baseline|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
10876983|NCT00444951|BG002|Baseline|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
10876984|NCT00444951|BG003|Baseline|Total|Total of all reporting groups
10876985|NCT00444951|FG000|Participant Flow|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
10876986|NCT00444951|FG001|Participant Flow|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
10876987|NCT00444951|FG002|Participant Flow|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
10876988|NCT00444951|OG000|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
10876989|NCT00444951|OG001|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
10876990|NCT00444951|OG002|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
10876991|NCT00444951|EG000|Reported Event|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
10876992|NCT00444951|EG001|Reported Event|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
10876993|NCT00444951|EG002|Reported Event|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
10876994|NCT00444964|BG000|Baseline|Primary Cohort|Nutropin AQ: 0.0125 mg/kg/day
10876995|NCT00444964|FG000|Participant Flow|Primary Cohort|Nutropin AQ: 0.0125 mg/kg/day
10876996|NCT00444964|OG000|Outcome|Primary Cohort|Nutropin AQ: 0.0125 mg/kg/day
10876997|NCT00444964|EG000|Reported Event|Primary Cohort|Nutropin AQ: 0.0125 mg/kg/day
10876998|NCT00445003|BG000|Baseline|Sham Injection|Sham injection at baseline and 4 weeks
10993963|NCT01021306|OG003|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
10993964|NCT01021306|EG000|Reported Event|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
10993965|NCT01021306|EG001|Reported Event|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
10993966|NCT01021306|EG002|Reported Event|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
10993967|NCT01021306|EG003|Reported Event|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
10993968|NCT01021332|BG000|Baseline|Total Group|Participants who received at least one dose of open-label FDC treatment
10993969|NCT01021332|FG000|Participant Flow|Total Group|Participants who received at least one dose of open-label FDC treatment
10993970|NCT01021332|OG000|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
10993971|NCT01021332|OG000|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
10993972|NCT01021332|OG000|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
10993973|NCT01021332|EG000|Reported Event|Total Group|Participants who received at least one dose of open-label FDC treatment
10993974|NCT01021423|BG000|Baseline|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
10993975|NCT01021423|BG001|Baseline|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
10993976|NCT01021423|BG002|Baseline|Total|Total of all reporting groups
10993977|NCT01021423|FG000|Participant Flow|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
10993978|NCT01021423|FG001|Participant Flow|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
11348244|NCT04195581|EG000|Reported Event|Comfilcon A With Hy-Care Multi-purpose Solution|Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solutionfor a month.
11348245|NCT04195581|EG001|Reported Event|Comfilcon A With All in One Light Multi-purpose Solution|Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.
10993979|NCT01021423|OG000|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
10993980|NCT01021423|OG001|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
10993981|NCT01021423|EG000|Reported Event|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
10993982|NCT01021423|EG001|Reported Event|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
10993983|NCT01021553|BG000|Baseline|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993984|NCT01021553|BG001|Baseline|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993985|NCT01021553|BG002|Baseline|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993986|NCT01021553|BG003|Baseline|Total|Total of all reporting groups
10993987|NCT01021553|FG000|Participant Flow|Placebo|Participants received 3 placebo tablets matching study drug approximately one hour prior to planned sexual intercourse (SI), once in a 24-hour time period, on-demand for 8 weeks.
10993988|NCT01021553|FG001|Participant Flow|GSK557296 50 mg|Participants received one 50 milligrams (mg) tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993989|NCT01021553|FG002|Participant Flow|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993990|NCT01021553|OG000|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
11223403|NCT02353169|FG002|Participant Flow|Dexmedetomidine 0.75mcg/kg|"0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11223404|NCT02353169|FG003|Participant Flow|Saline Bolus|"10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~normal saline solution"
10993991|NCT01021553|OG001|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993992|NCT01021553|OG002|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993993|NCT01021553|OG003|Outcome|Pooled GSK557296|These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
10993994|NCT01021553|OG000|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993995|NCT01021553|OG001|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993996|NCT01021553|OG001|Outcome|GSK557296 50mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks
10993997|NCT01021553|OG002|Outcome|GSK557296 150mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993998|NCT01021553|EG000|Reported Event|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10993999|NCT01021553|EG001|Reported Event|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10994000|NCT01021553|EG002|Reported Event|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
10994001|NCT01021618|BG000|Baseline|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
10994002|NCT01021618|BG001|Baseline|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
10994003|NCT01021618|BG002|Baseline|Total|Total of all reporting groups
10994004|NCT01021618|FG000|Participant Flow|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
10994005|NCT01021618|FG001|Participant Flow|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
10994006|NCT01021618|OG000|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
10994007|NCT01021618|OG001|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
10994008|NCT01021618|EG000|Reported Event|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
10994009|NCT01021618|EG001|Reported Event|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
10994010|NCT01021683|BG000|Baseline|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
10994011|NCT01021683|FG000|Participant Flow|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
11223405|NCT02353169|OG000|Outcome|Dexmedetomidine 0.25mcg/kg|"0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11223406|NCT02353169|OG001|Outcome|Dexmedetomidine 0.5mcg/kg|"0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
10994012|NCT01021683|OG000|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
10994013|NCT01021683|EG000|Reported Event|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
10994014|NCT01021748|BG000|Baseline|MK-2206 45 mg QOD + AZD6244 75 mg QD|Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994015|NCT01021748|BG001|Baseline|MK-2206 45 mg QOD + AZD6244 75 mg BID|Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994016|NCT01021748|BG002|Baseline|MK-2206 90 mg QW + AZD6244 50 mg BID|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994017|NCT01021748|BG003|Baseline|MK-2206 90 mg QW + AZD6244 75 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994018|NCT01021748|BG004|Baseline|MK-2206 90 mg QW + AZD6244 75 mg BID|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994019|NCT01021748|BG005|Baseline|MK-2206 90 mg QW + AZD6244 100 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994020|NCT01021748|BG006|Baseline|MK-2206 90 mg QW + AZD6244 150 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994021|NCT01021748|BG007|Baseline|MK-2206 100 mg QW + AZD6244 100 mg QD|Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994022|NCT01021748|BG008|Baseline|MK-2206 135 mg QW + AZD6244 100 mg QD|Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994023|NCT01021748|BG009|Baseline|Total|Total of all reporting groups
10994024|NCT01021748|FG000|Participant Flow|MK-2206 45 mg QOD + AZD6244 75 mg QD|Participants received MK-2206 45 mg oral tablets once every other day (QOD) PLUS AZD6244 75 mg oral capsules once daily (QD) starting on Day 1 of each 28-day cycle.
10994025|NCT01021748|FG001|Participant Flow|MK-2206 45 mg QOD + AZD6244 75 mg BID|Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules twice daily (BID) starting on Day 1 of each 28-day cycle.
10994026|NCT01021748|FG002|Participant Flow|MK-2206 90 mg QW + AZD6244 50 mg BID|Participants received MK-2206 90 mg oral tablets once weekly (QW) PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994027|NCT01021748|FG003|Participant Flow|MK-2206 90 mg QW + AZD6244 75 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994028|NCT01021748|FG004|Participant Flow|MK-2206 90 mg QW + AZD6244 75 mg BID|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994029|NCT01021748|FG005|Participant Flow|MK-2206 90 mg QW + AZD6244 100 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994030|NCT01021748|FG006|Participant Flow|MK-2206 90 mg QW + AZD6244 150 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994031|NCT01021748|FG007|Participant Flow|MK-2206 100 mg QW + AZD6244 100 mg QD|Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994032|NCT01021748|FG008|Participant Flow|MK-2206 135 mg QW + AZD6244 100 mg QD|Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994033|NCT01021748|OG000|Outcome|MK-2206 45 mg QOD + AZD6244 75 mg QD|Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994034|NCT01021748|OG001|Outcome|MK-2206 45 mg QOD + AZD6244 75 mg BID|Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994035|NCT01021748|OG002|Outcome|MK-2206 90 mg QW + AZD6244 50 mg BID|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994036|NCT01021748|OG003|Outcome|MK-2206 90 mg QW + AZD6244 75 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
11348246|NCT04195581|EG002|Reported Event|Comfilcon A With Refine One Step Hydrogen Peroxide Solution|Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
10994037|NCT01021748|OG004|Outcome|MK-2206 90 mg QW + AZD6244 75 mg BID|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994038|NCT01021748|OG005|Outcome|MK-2206 90 mg QW + AZD6244 100 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994039|NCT01021748|OG006|Outcome|MK-2206 90 mg QW + AZD6244 150 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994040|NCT01021748|OG007|Outcome|MK-2206 100 mg QW + AZD6244 100 mg QD|Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994041|NCT01021748|OG008|Outcome|MK-2206 135 mg QW + AZD6244 100 mg QD|Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994042|NCT01021748|EG000|Reported Event|MK-2206 45 mg QOD + AZD6244 75 mg QD|Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994043|NCT01021748|EG001|Reported Event|MK-2206 45 mg QOD + AZD6244 75 mg BID|Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994044|NCT01021748|EG002|Reported Event|MK-2206 90 mg QW + AZD6244 50 mg BID|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994045|NCT01021748|EG003|Reported Event|MK-2206 90 mg QW + AZD6244 75 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994046|NCT01021748|EG004|Reported Event|MK-2206 90 mg QW + AZD6244 75 mg BID|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
10994047|NCT01021748|EG005|Reported Event|MK-2206 90 mg QW + AZD6244 100 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994048|NCT01021748|EG006|Reported Event|MK-2206 90 mg QW + AZD6244 150 mg QD|Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994049|NCT01021748|EG007|Reported Event|MK-2206 100 mg QW + AZD6244 100 mg QD|Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994050|NCT01021748|EG008|Reported Event|MK-2206 135 mg QW + AZD6244 100 mg QD|Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
10994051|NCT01021761|BG000|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
11223407|NCT02353169|OG002|Outcome|Dexmedetomidine 0.75mcg/kg|"0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11348247|NCT04195581|EG003|Reported Event|Fanfilcon A With Hy-Care Multi-purpose Solution|Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.
10994052|NCT01021761|BG001|Baseline|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
10994053|NCT01021761|BG002|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
10994054|NCT01021761|BG003|Baseline|Total|Total of all reporting groups
10994055|NCT01021761|FG000|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
10994056|NCT01021761|FG001|Participant Flow|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
10994057|NCT01021761|FG002|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
10994058|NCT01021761|OG000|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
10994059|NCT01021761|OG001|Outcome|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
10994060|NCT01021761|OG002|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
10994061|NCT01021761|EG000|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
10994062|NCT01021761|EG001|Reported Event|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
10994063|NCT01021761|EG002|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
10994064|NCT01021813|BG000|Baseline|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
10994065|NCT01021813|BG001|Baseline|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
10994066|NCT01021813|BG002|Baseline|Total|Total of all reporting groups
10994067|NCT01021813|FG000|Participant Flow|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
10994068|NCT01021813|FG001|Participant Flow|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
10994069|NCT01021813|FG002|Participant Flow|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
10994070|NCT01021813|FG003|Participant Flow|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
10994071|NCT01021813|FG004|Participant Flow|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
10994072|NCT01021813|OG000|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
10994073|NCT01021813|OG001|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
10994074|NCT01021813|OG000|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
11223408|NCT02353169|OG003|Outcome|Saline Bolus|"10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~normal saline solution"
10994075|NCT01021813|OG001|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
10994076|NCT01021813|OG002|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
10994077|NCT01021813|OG000|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase. Following the Treatment Phase, these participants were randomized (at baseline) to suvorexant or placebo during the 2-month Randomized Discontinuation Phase.
10994078|NCT01021813|OG001|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase. Following the Treatment Phase, these participants continued on placebo during the 2-month Randomized Discontinuation Phase.
10994079|NCT01021813|EG000|Reported Event|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
10994080|NCT01021813|EG001|Reported Event|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
10994081|NCT01021813|EG002|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
10994082|NCT01021813|EG003|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
10994083|NCT01021813|EG004|Reported Event|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
10994084|NCT01021813|EG005|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Run-out)/Follow-up|Following treatment with suvorexant during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
10994085|NCT01021813|EG006|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with suvorexant during the 12-Month DB Treatment Period and treatment with dose-matched placebo during the DB the Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
10994086|NCT01021813|EG007|Reported Event|Placebo (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with dose-matched placebo during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
10994087|NCT01021852|BG000|Baseline|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
10994088|NCT01021852|BG001|Baseline|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
10994089|NCT01021852|BG002|Baseline|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
11007537|NCT01091363|BG001|Baseline|Standard|"This arm receives eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture.~nicotine patch: 8-week nicotine patch therapy"
11007538|NCT01091363|BG002|Baseline|Total|Total of all reporting groups
10994090|NCT01021852|BG003|Baseline|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
10994091|NCT01021852|BG004|Baseline|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
10994092|NCT01021852|BG005|Baseline|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
10994093|NCT01021852|BG006|Baseline|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
10994094|NCT01021852|BG007|Baseline|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
10994095|NCT01021852|BG008|Baseline|Total|Total of all reporting groups
10994096|NCT01021852|FG000|Participant Flow|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
10994097|NCT01021852|FG001|Participant Flow|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
11007539|NCT01091363|FG000|Participant Flow|Deep Cultural|"This arm received eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT~nicotine patch: 8-week nicotine patch therapy"
11007540|NCT01091363|FG001|Participant Flow|Standard|"This arm received eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture.~nicotine patch: 8-week nicotine patch therapy"
11348248|NCT04195581|EG004|Reported Event|Fanfilcon A With All in One Light Multi-purpose Solution|Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solutionfor a month.
11348249|NCT04195581|EG005|Reported Event|Fanfilcon A With Refine One Step Hydrogen Peroxide Solution|Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solutionfor a month.
10994098|NCT01021852|FG002|Participant Flow|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
10994099|NCT01021852|FG003|Participant Flow|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
10994100|NCT01021852|FG004|Participant Flow|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
10994101|NCT01021852|FG005|Participant Flow|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
10994102|NCT01021852|FG006|Participant Flow|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
10994103|NCT01021852|FG007|Participant Flow|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
10994104|NCT01021852|OG000|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
10994105|NCT01021852|OG001|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
10994106|NCT01021852|OG002|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
10994107|NCT01021852|OG003|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
10994108|NCT01021852|OG004|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
10994109|NCT01021852|EG000|Reported Event|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
10994110|NCT01021852|EG001|Reported Event|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
10994111|NCT01021852|EG002|Reported Event|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
11348250|NCT04194151|BG000|Baseline|2 Minute - 2 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol
10994112|NCT01021852|EG003|Reported Event|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
10994113|NCT01021852|EG004|Reported Event|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
10994114|NCT01021852|EG005|Reported Event|Washout|Participants administered single-blind placebo study medication for the first 3 nights of the washout period that occurred between Treatment Period 1 and Treatment Period 2, immediately prior to bedtime. The remaining 11 days of the washout period constituted a drug holiday during which time no study medication was administered.
10994115|NCT01021852|EG006|Reported Event|Post-Study/Follow-up|Participants that completed the study or prematurely discontinued during either treatment period received a 14-day (from last dose) follow-up phone call to assess for AEs. The Post-Study/Follow-up period was the period that occurred between study completion/ treatment discontinuation and the 14-day follow-up phone call (14 days after the last dose of double-blind study medication).
10994116|NCT01021878|BG000|Baseline|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
10994117|NCT01021878|BG001|Baseline|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
10994118|NCT01021878|BG002|Baseline|Total|Total of all reporting groups
10994119|NCT01021878|FG000|Participant Flow|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~N=33"
10994120|NCT01021878|FG001|Participant Flow|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~N=27"
10994121|NCT01021878|OG000|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
10994122|NCT01021878|OG001|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
10994123|NCT01021878|OG000|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
10994124|NCT01021878|OG001|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
10994125|NCT01021878|OG001|Outcome|Dextrose|"dianeal, Control group, standard treatment~Dianeal: glucose based dialysis solution"
10994126|NCT01021878|EG000|Reported Event|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
10994127|NCT01021878|EG001|Reported Event|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
10994128|NCT01021956|BG000|Baseline|Group 1a|2.5 mg/kg - 25 Joules/cm²
10994129|NCT01021956|BG001|Baseline|Group 1b|2.5 mg/kg - 12.6 Joules/cm²
10994130|NCT01021956|BG002|Baseline|Group 1c|2.5 mg/kg - 18.9 Joules/cm²
10994131|NCT01021956|BG003|Baseline|Group 2|2.5 mg/kg - 50 Joules/cm²
10994132|NCT01021956|BG004|Baseline|Total|Total of all reporting groups
10994133|NCT01021956|FG000|Participant Flow|Group 1a -2.5 mg/kg STAKEL - 25 J/cm²|2.5 mg/kg dose of STAKEL - 25 Joules/cm² of laser light at 753 nm
10994134|NCT01021956|FG001|Participant Flow|Group 1b-2.5 mg/kg STAKEL - 12.6 J/cm²|2.5 mg/kg dose of STAKEL -12.6 Joules/cm² of laser light at 753 nm
10994135|NCT01021956|FG002|Participant Flow|Group 1c-2.5 mg/kg STAKEL - 18.9 J/cm²|2.5 mg/kg dose of STAKEL -18.9 Joules/cm² of laser light at 753 nm
10994136|NCT01021956|FG003|Participant Flow|Group 2-2.5 mg/kg STAKEL - 50 J/cm²|2.5 mg/kg dose of STAKEL - 50 Joules/cm² of laser light at 753 nm
10994137|NCT01021956|OG000|Outcome|Group 1a|2.5 mg/kg - 25 Joules/cm²
10994138|NCT01021956|OG001|Outcome|Group 1b|2.5 mg/kg - 12.6 Joules/cm²
10994139|NCT01021956|OG002|Outcome|Group 1c|2.5 mg/kg - 18.9 Joules/cm²
10994140|NCT01021956|OG003|Outcome|Group 2|2.5 mg/kg - 50 Joules/cm²
10994141|NCT01021956|OG004|Outcome|Overall|All doses of TOOKAD Soluble and Laser Light
10994142|NCT01021956|EG000|Reported Event|Group 1A|2.5 mg/kg - 25 Joules/cm²
10994143|NCT01021956|EG001|Reported Event|Group 1B|2.5 mg/kg - 12.6 Joules/cm²
10994144|NCT01021956|EG002|Reported Event|Group 1C|2.5 mg/kg - 18.9 Joules/cm²
10994145|NCT01021956|EG003|Reported Event|Group 2|2.5 mg/kg - 50 Joules/cm²
10994146|NCT01022073|BG000|Baseline|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
10994147|NCT01022073|BG001|Baseline|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
10994148|NCT01022073|BG002|Baseline|Total|Total of all reporting groups
10994149|NCT01022073|FG000|Participant Flow|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
10994150|NCT01022073|FG001|Participant Flow|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
10994151|NCT01022073|OG000|Outcome|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
10994152|NCT01022073|OG001|Outcome|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
10994153|NCT01022073|EG000|Reported Event|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
10994154|NCT01022073|EG001|Reported Event|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
10994155|NCT01022112|BG000|Baseline|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
10994156|NCT01022112|BG001|Baseline|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
10994157|NCT01022112|BG002|Baseline|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
10994158|NCT01022112|BG003|Baseline|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
10994159|NCT01022112|BG004|Baseline|Placebo|TA-7284 Placebo, once daily for 12 weeks
10994160|NCT01022112|BG005|Baseline|Total|Total of all reporting groups
10994161|NCT01022112|FG000|Participant Flow|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
10994162|NCT01022112|FG001|Participant Flow|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
10994163|NCT01022112|FG002|Participant Flow|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
10994164|NCT01022112|FG003|Participant Flow|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
10994165|NCT01022112|FG004|Participant Flow|Placebo|TA-7284 Placebo, once daily for 12 weeks
10994166|NCT01022112|OG000|Outcome|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
10994167|NCT01022112|OG001|Outcome|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
10994168|NCT01022112|OG002|Outcome|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
10994169|NCT01022112|OG003|Outcome|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
10994170|NCT01022112|OG004|Outcome|Placebo|TA-7284 Placebo, once daily for 12 weeks
10994171|NCT01022112|EG000|Reported Event|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
10994172|NCT01022112|EG001|Reported Event|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
10994173|NCT01022112|EG002|Reported Event|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
10994174|NCT01022112|EG003|Reported Event|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
10994175|NCT01022112|EG004|Reported Event|Placebo|TA-7284 Placebo, once daily for 12 weeks
10994176|NCT01022190|BG000|Baseline|Etoricoxib|
10994177|NCT01022190|FG000|Participant Flow|Etoricoxib, 90 mg, Orally, Ones a Day|Patients who underwent total hip arthroplasty were administered Etoricoxib, 90 mg, orally, one a day for a 7 day period to prevent heterotopic ossification of the hip joint after the operation.
10994178|NCT01022190|OG000|Outcome|Etoricoxib, 90 mg, Orally, One a Day for 7 Days Period|Etoricoxib, 90 mg, which was administered orally, for a 7-day period to all participants.
10994179|NCT01022190|EG000|Reported Event|Etoricoxib|
10994180|NCT01022203|BG000|Baseline|Arm 1|"Couple's Therapy Intervention~Structured Approach Therapy: Couple's Therapy for PTSD"
10994181|NCT01022203|BG001|Baseline|Arm 2|"Educational Intervention.~PTSD Family Education: Education about PTSD for couples."
10994182|NCT01022203|BG002|Baseline|Total|Total of all reporting groups
10994183|NCT01022203|FG000|Participant Flow|Structured Approach Therapy|"Couple's Therapy Intervention~Structured Approach Therapy: Couple's Therapy for PTSD"
10994184|NCT01022203|FG001|Participant Flow|PTSD Family Education|"Educational Intervention.~PTSD Family Education: Education about PTSD for couples."
10994185|NCT01022203|OG000|Outcome|Structured Approach Therapy|Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
10994186|NCT01022203|OG001|Outcome|PTSD Family Education|Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
10994187|NCT01022203|OG000|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
10994188|NCT01022203|OG001|Outcome|PTSD Family Education|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
10994189|NCT01022203|OG001|Outcome|PTSD Family Education|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
10994190|NCT01022203|EG000|Reported Event|Structured Approach Therapy (SAT)|"Couple-Based Intervention called Structured Approach Therapy (SAT) provides skills training to couple so they can reduce PTSD.~Structured Approach Therapy (SAT): Structured Approach Therapy (SAT) intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication."
10994191|NCT01022203|EG001|Reported Event|PTSD Family Education (PFE)|"Couple-Based Education called PTSD Family Education (PFE) teaches couple about PTSD symptoms, related problems, and treatment.~PTSD Family Education (PFE): PTSD Family Education (PFE) provides education for veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included."
10994192|NCT01022242|BG000|Baseline|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
10994193|NCT01022242|BG001|Baseline|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
10994194|NCT01022242|BG002|Baseline|Total|Total of all reporting groups
10994195|NCT01022242|FG000|Participant Flow|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo: Placebo is a physiological sodium chloride solution, which is clear and colourless."
11348251|NCT04194151|BG001|Baseline|2 Minute - 1,5 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol
10876999|NCT00445003|BG001|Baseline|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
10877000|NCT00445003|BG002|Baseline|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
10877001|NCT00445003|BG003|Baseline|Total|Total of all reporting groups
10877002|NCT00445003|FG000|Participant Flow|Sham Injection|Sham injection at baseline and 4 weeks
10877003|NCT00445003|FG001|Participant Flow|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
10877004|NCT00445003|FG002|Participant Flow|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
10877005|NCT00445003|OG000|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
10877006|NCT00445003|OG001|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
10877007|NCT00445003|OG002|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
10877008|NCT00445003|EG000|Reported Event|Sham Injection|Sham injection at baseline and 4 weeks
10877009|NCT00445003|EG001|Reported Event|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
10877010|NCT00445003|EG002|Reported Event|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
10877011|NCT00445068|BG000|Baseline|Panobinostat|Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle.
10877012|NCT00445068|FG000|Participant Flow|Panobinostat|Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
10877013|NCT00445068|OG000|Outcome|Panobinostat|Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
10877014|NCT00445068|EG000|Reported Event|Panobinostat|Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle.
10877015|NCT00445146|BG000|Baseline|EVG+RTV|EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2.
10877016|NCT00445146|FG000|Participant Flow|EVG+RTV|"Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
10877017|NCT00445146|OG000|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
10877018|NCT00445146|EG000|Reported Event|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
10877019|NCT00445211|BG000|Baseline|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
10877020|NCT00445211|BG001|Baseline|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
10877021|NCT00445211|BG002|Baseline|Total|Total of all reporting groups
10877022|NCT00445211|FG000|Participant Flow|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
10877023|NCT00445211|FG001|Participant Flow|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
10877024|NCT00445211|OG000|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
10877025|NCT00445211|OG001|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
10877026|NCT00445211|EG000|Reported Event|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
10877027|NCT00445211|EG001|Reported Event|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
10877028|NCT00445224|BG000|Baseline|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
10877029|NCT00445224|BG001|Baseline|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
10877030|NCT00445224|BG002|Baseline|Total|Total of all reporting groups
10877031|NCT00445224|FG000|Participant Flow|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
10877032|NCT00445224|FG001|Participant Flow|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
10877033|NCT00445224|OG000|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
10877034|NCT00445224|OG001|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
10994196|NCT01022242|FG001|Participant Flow|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01: PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
10994197|NCT01022242|OG000|Outcome|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
10994198|NCT01022242|OG001|Outcome|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
10994199|NCT01022242|EG000|Reported Event|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
10994200|NCT01022242|EG001|Reported Event|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
10994201|NCT01022307|BG000|Baseline|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
10994202|NCT01022307|BG001|Baseline|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
10994203|NCT01022307|BG002|Baseline|Total|Total of all reporting groups
10994204|NCT01022307|FG000|Participant Flow|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
10994205|NCT01022307|FG001|Participant Flow|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI.
10994206|NCT01022307|OG000|Outcome|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
10994207|NCT01022307|OG001|Outcome|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. Two were excluded because of evidence of malingering.
10994208|NCT01022307|EG000|Reported Event|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
10994209|NCT01022307|EG001|Reported Event|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
10994210|NCT01022359|BG000|Baseline|Tesio Catheter|"Patients randomised to receive the established catheter type in use at our centre [control]~TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access"
10994211|NCT01022359|BG001|Baseline|LifeCath|"Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)~LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access"
10994212|NCT01022359|BG002|Baseline|Total|Total of all reporting groups
10994213|NCT01022359|FG000|Participant Flow|Tesio Catheter|"Patients randomised to receive the established catheter type in use at our centre [control]~TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access"
10994214|NCT01022359|FG001|Participant Flow|LifeCath|"Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)~LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access"
10994215|NCT01022359|OG000|Outcome|Tesio Catheter|"Patients randomised to receive the established catheter type in use at our centre [control]~TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access"
11348252|NCT04194151|BG002|Baseline|2 Minute - 1 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol
10994216|NCT01022359|OG001|Outcome|LifeCath|"Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)~LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access"
10994217|NCT01022359|EG000|Reported Event|Tesio Catheter|"Patients randomised to receive the established catheter type in use at our centre [control]~TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access"
10994218|NCT01022359|EG001|Reported Event|LifeCath|"Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)~LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access"
10994219|NCT01022424|BG000|Baseline|OPC-41061|"Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol."
11223409|NCT02353169|EG000|Reported Event|Dexmedetomidine 0.25mcg/kg|"0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
10994220|NCT01022424|FG000|Participant Flow|OPC-41061|"Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol."
10994221|NCT01022424|OG000|Outcome|Baseline|"Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol."
10994222|NCT01022424|OG001|Outcome|Week 48|"Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol."
10994223|NCT01022424|OG002|Outcome|Week 96|"Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol."
10994224|NCT01022424|OG003|Outcome|Week 144|"Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol."
10994225|NCT01022424|OG004|Outcome|Week 192|"Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol."
11223410|NCT02353169|EG001|Reported Event|Dexmedetomidine 0.5mcg/kg|"0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
11223411|NCT02353169|EG002|Reported Event|Dexmedetomidine 0.75mcg/kg|"0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~Dexmedetomidine"
10994226|NCT01022424|EG000|Reported Event|OPC-41061|"Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol."
10994227|NCT01022502|BG000|Baseline|All Participants (Refined/Crude Ointment)|Two symmetrically comparable plaques on each participant were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Photographs of the lesions were taken and lesion severity was evaluated at baseline and at week 2, 4, 6, and 8.
10994228|NCT01022502|FG000|Participant Flow|All Participants|In all participants, two bilateral symmetric plaques were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Participants were instructed to avoid cross-contamination between the two treatment sites by washing hands throughly between applications. Treatment was performed until complete clearing, up to a maxmum period of 8 weeks.
10994229|NCT01022502|OG000|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
10994230|NCT01022502|OG001|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
10994231|NCT01022502|EG000|Reported Event|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax.
10994232|NCT01022502|EG001|Reported Event|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax.
10994233|NCT01022567|BG000|Baseline|Operative Treatment|"Regular open appendicectomy~Appendicectomy: Standard appendicectomy"
10994234|NCT01022567|BG001|Baseline|Antibiotic Treatment|"Ertapenem 1 g i.v. x 1 three days~Ertapenem: ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o."
10994235|NCT01022567|BG002|Baseline|Total|Total of all reporting groups
10994236|NCT01022567|FG000|Participant Flow|Appendectomy|Open appendectomy
10994237|NCT01022567|FG001|Participant Flow|Antibiotic Therapy|Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days.
10994238|NCT01022567|OG000|Outcome|Appendectomy|
10994239|NCT01022567|OG001|Outcome|Antibiotic Therapy|
10994240|NCT01022567|EG000|Reported Event|Appendectomy|Open appendectomy
10994241|NCT01022567|EG001|Reported Event|Antibiotic Therapy|Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days
10994242|NCT01022580|BG000|Baseline|Infasurf Surfactant (ONY, Inc.)|"Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.~Infasurf surfactant (ONY, Inc.): Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8."
10994243|NCT01022580|BG001|Baseline|Sham|Infants already receiving inhaled nitric oxide will not receive additional doses of late surfactant (Infasurf).
10994244|NCT01022580|BG002|Baseline|Total|Total of all reporting groups
11223412|NCT02353169|EG003|Reported Event|Saline Bolus|"10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.~normal saline solution"
11223413|NCT02353299|BG000|Baseline|All Study Participants|A single group of subjects were recruited and assigned all study treatments in random order
11223414|NCT02353299|FG000|Participant Flow|PBO-4H Then PBO-1.5H Then DXP-4H Then ZOL-1.5H|Period 1: Doxepin-matching placebo-single nighttime dose Period 2: Zolpidem-matching placebo-single nighttime dose Period 3: Doxepin 6mg-single nighttime dose Period 4: Zolpidem 10 mg-single nighttime dose
10994245|NCT01022580|FG000|Participant Flow|Infasurf Surfactant (ONY, Inc.)|"Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.~Infasurf surfactant (ONY, Inc.): Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8."
10994246|NCT01022580|FG001|Participant Flow|Sham|Infants already receiving inhaled nitric oxide will not receive additional doses of late surfactant (Infasurf).
10994247|NCT01022580|OG000|Outcome|Infasurf Surfactant (ONY, Inc.)|"Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, and repeated Q24-72 hours as long as infant remains ventilated.~Infasurf surfactant (ONY, Inc.): Late doses of Infasurf 3ml/kg will be given to infants on study days 0, and repeated Q24-72 hours as long as infant remains ventilated."
10994248|NCT01022580|OG001|Outcome|Sham|"Infants already receiving inhaled nitric oxide will receive scheduled sham (nothing done) doses of late surfactant (nothing done).~Sham (nothing done) doses will be given to infants on study days 0,and repeated Q24-72 hours as long as infant remains ventilated."
10994249|NCT01022580|OG000|Outcome|Infasurf Surfactant (ONY, Inc.)|"Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) upon entry into study.~Repeat Infasurf surfactant (ONY, Inc.) doses will be given to infants still ventilated on study days (+/- 24 hours): 2, 4, 6 and 8."
10994250|NCT01022580|OG001|Outcome|Sham|"Infants already receiving inhaled nitric oxide will receive Sham (no treatment) upon entry into study.~Repeat Sham doses will be given to infants still ventilated on study days (+/- 24 hours): 2, 4, 6 and 8."
10994251|NCT01022580|OG000|Outcome|Infasurf Surfactant (ONY, Inc.)|Infants who received inhaled nitric oxide and late doses of surfactant will have respiratory questionaires administered by phone at 3,6,9 and 12 months.
10994252|NCT01022580|OG001|Outcome|Sham|Infants who received only inhaled nitric oxide will have respiratory questionaires administered by phone at 3,6,9 and 12 months
10994253|NCT01022580|OG000|Outcome|Infasurf Surfactant (ONY, Inc.)|"Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.~Infasurf surfactant (ONY, Inc.): Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8."
10994254|NCT01022580|OG001|Outcome|Sham|Infants already receiving inhaled nitric oxide will not receive additional doses of late surfactant (Infasurf).
10994255|NCT01022580|EG000|Reported Event|Infasurf Surfactant (ONY, Inc.)|"Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.~Infasurf surfactant (ONY, Inc.): Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated."
10994256|NCT01022580|EG001|Reported Event|Sham (No Treatment)|"Infants already receiving inhaled nitric oxide will receive Sham (no treatment) doses on study days 0,2,4,6, and 8.~Sham (No Treatment): Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated."
10994257|NCT01022762|BG000|Baseline|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
10994258|NCT01022762|BG001|Baseline|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
10994259|NCT01022762|BG002|Baseline|Total|Total of all reporting groups
10994260|NCT01022762|FG000|Participant Flow|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
10994261|NCT01022762|FG001|Participant Flow|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
10994262|NCT01022762|OG000|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
10994263|NCT01022762|OG001|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
10994264|NCT01022762|EG000|Reported Event|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
10994265|NCT01022762|EG001|Reported Event|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
10994266|NCT01022853|BG000|Baseline|100 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994267|NCT01022853|BG001|Baseline|200 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994268|NCT01022853|BG002|Baseline|300 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994269|NCT01022853|BG003|Baseline|350 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
11348253|NCT04194151|BG003|Baseline|1 Minute - 2 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol
10994270|NCT01022853|BG004|Baseline|400 mg Volasertib + 200 mg Nintedanib|Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
10994271|NCT01022853|BG005|Baseline|Total|Total of all reporting groups
10994272|NCT01022853|FG000|Participant Flow|100 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994273|NCT01022853|FG001|Participant Flow|200 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994274|NCT01022853|FG002|Participant Flow|300 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994275|NCT01022853|FG003|Participant Flow|350 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994276|NCT01022853|FG004|Participant Flow|400 mg Volasertib + 200 mg Nintedanib|Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
10994277|NCT01022853|OG000|Outcome|100 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994278|NCT01022853|OG001|Outcome|200 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994279|NCT01022853|OG002|Outcome|300 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994280|NCT01022853|OG003|Outcome|350 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994281|NCT01022853|OG004|Outcome|400 mg Volasertib + 200 mg Nintedanib|Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
10994282|NCT01022853|OG000|Outcome|100 mg Volasertib + 200 mg Nintedanib|Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
10994283|NCT01022853|OG000|Outcome|Volasertib in Combination With Nintedanib|All patients received both Volasertib and Nintedanib. Starting dose of Volasertib was 100 mg, the next dose levels were 200 mg, 300 mg, 350 mg and 400 mg, which was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
10994284|NCT01022853|OG005|Outcome|Total Patients|All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
10994285|NCT01022853|EG000|Reported Event|100 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
11348254|NCT04194151|BG004|Baseline|1 Minute - 1,5 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol
11348255|NCT04194151|BG005|Baseline|1 Minute - 1 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
10994286|NCT01022853|EG001|Reported Event|200 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994287|NCT01022853|EG002|Reported Event|300 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994288|NCT01022853|EG003|Reported Event|350 mg Volasertib + 200 mg Nintedanib|"Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.~Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2."
10994289|NCT01022853|EG004|Reported Event|400 mg Volasertib + 200 mg Nintedanib|Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
10994290|NCT01022996|BG000|Baseline|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
10994291|NCT01022996|FG000|Participant Flow|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
10994292|NCT01022996|OG000|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
10994293|NCT01022996|EG000|Reported Event|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
10994294|NCT01023022|BG000|Baseline|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
10994295|NCT01023022|FG000|Participant Flow|Medtronic CareLink® Network|"Patients with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
10994296|NCT01023022|OG000|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
10994297|NCT01023022|EG000|Reported Event|Patients With Implanted ICD or CRT-D Devices|Patients with implanted ICD or CRT-D devices, who will be monitored via CareLink Network System
10994298|NCT01023035|BG000|Baseline|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
11348256|NCT04194151|BG006|Baseline|Total|Total of all reporting groups
10994299|NCT01023035|BG001|Baseline|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
10994300|NCT01023035|BG002|Baseline|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
10994301|NCT01023035|BG003|Baseline|Total|Total of all reporting groups
10994302|NCT01023035|FG000|Participant Flow|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
10994303|NCT01023035|FG001|Participant Flow|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
10994304|NCT01023035|FG002|Participant Flow|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
10994305|NCT01023035|OG000|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
10994306|NCT01023035|OG001|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
10994307|NCT01023035|OG000|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
10994308|NCT01023035|OG001|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
10994309|NCT01023035|OG002|Outcome|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
10994310|NCT01023035|EG000|Reported Event|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
10994311|NCT01023035|EG001|Reported Event|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
10994312|NCT01023035|EG002|Reported Event|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
10994313|NCT01023061|BG000|Baseline|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
10994314|NCT01023061|FG000|Participant Flow|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
10994315|NCT01023061|OG000|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given PO~prednisone: Given PO~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
11348257|NCT04194151|FG000|Participant Flow|2 Minute - 2 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol
10994316|NCT01023061|EG000|Reported Event|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
10994317|NCT01023074|BG000|Baseline|Non-MS Control|Non-MS control group
10994318|NCT01023074|BG001|Baseline|MS:Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
11223415|NCT02353299|FG001|Participant Flow|PBO-1.5H Then ZOL-1.5H Then PBO-4H Then DXP-4H|Period 1: Zolpidem-matching placebo-single nighttime dose Period 2: Zolpidem 10 mg-single nighttime dose Period 3: Doxepin-matching placebo-single nighttime dose Period 4: Doxepin 6mg-single nighttime dose
11223416|NCT02353299|FG002|Participant Flow|ZOL-1.5H Then DXP-4H Then PBO-1.5H Then PBO-4H|Period 1: Zolpidem 10mg-single nighttime dose Period 2: Doxepin 6mg-single nighttime dose Period 3: Zolpidem-matching placebo-single nighttime dose Period 4: Doxepin-matching placebo-single nighttime dose
11223417|NCT02353299|FG003|Participant Flow|DXP-4H Then PBO-4H Then ZOL-1.5H Then PBO-1.5H|Period 1: Doxepin 6mg-single nighttime dose Period 2: Doxepin-matching placebo-single nighttime dose Period 3: Zolpidem 10mg-single nighttime dose Period 4: Zolpidem-matching placebo-single nighttime dose
11223418|NCT02353299|OG000|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
11223419|NCT02353299|OG001|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
11223420|NCT02353299|OG002|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
11223421|NCT02353299|OG003|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
11223422|NCT02353299|OG000|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
11348258|NCT04194151|FG001|Participant Flow|2 Minute - 1,5 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol
10994319|NCT01023074|BG002|Baseline|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
10994320|NCT01023074|BG003|Baseline|Total|Total of all reporting groups
10994321|NCT01023074|FG000|Participant Flow|Non-MS Control|Non-MS control group
10994322|NCT01023074|FG001|Participant Flow|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
10994323|NCT01023074|FG002|Participant Flow|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
10994324|NCT01023074|OG000|Outcome|Arm 1|Non-MS control group
10994325|NCT01023074|OG001|Outcome|Arm 2|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
10994326|NCT01023074|OG002|Outcome|Arm 3|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
11223423|NCT02353299|OG001|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
11223424|NCT02353299|OG000|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
11223425|NCT02353299|OG001|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
11223426|NCT02353299|OG002|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
11223427|NCT02353299|OG003|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
11223428|NCT02353299|OG000|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
11223429|NCT02353299|OG001|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
11223430|NCT02353299|EG000|Reported Event|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
10994327|NCT01023074|OG000|Outcome|Non-MS Control|Non-MS control group
10994328|NCT01023074|OG001|Outcome|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
10994329|NCT01023074|OG002|Outcome|MS: Control Activity|MS group not receiving auditory training, doing control activity
10994330|NCT01023074|OG002|Outcome|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
10994331|NCT01023074|EG000|Reported Event|Non-MS Control|Non-MS control group
10994332|NCT01023074|EG001|Reported Event|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
10994333|NCT01023074|EG002|Reported Event|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
10994334|NCT01023178|BG000|Baseline|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
10994335|NCT01023178|BG001|Baseline|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
11348259|NCT04194151|FG002|Participant Flow|2 Minutes - 1 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol
11223431|NCT02353299|EG001|Reported Event|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
10994336|NCT01023178|BG002|Baseline|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
10994337|NCT01023178|BG003|Baseline|Total|Total of all reporting groups
10994338|NCT01023178|FG000|Participant Flow|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
10994339|NCT01023178|FG001|Participant Flow|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
10994340|NCT01023178|FG002|Participant Flow|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
10994341|NCT01023178|OG000|Outcome|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
10994342|NCT01023178|OG001|Outcome|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
10994343|NCT01023178|OG002|Outcome|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
10994344|NCT01023178|EG000|Reported Event|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
10994345|NCT01023178|EG001|Reported Event|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
10994346|NCT01023178|EG002|Reported Event|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
10994347|NCT01023217|BG000|Baseline|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
10994348|NCT01023217|BG001|Baseline|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
10994349|NCT01023217|BG002|Baseline|Total|Total of all reporting groups
10994350|NCT01023217|FG000|Participant Flow|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
10994351|NCT01023217|FG001|Participant Flow|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
10994352|NCT01023217|OG000|Outcome|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
10994353|NCT01023217|OG001|Outcome|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
10994354|NCT01023217|EG000|Reported Event|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
10994355|NCT01023217|EG001|Reported Event|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
11223432|NCT02353299|EG002|Reported Event|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
10994356|NCT01023256|BG000|Baseline|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994357|NCT01023256|BG001|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994358|NCT01023256|BG002|Baseline|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994359|NCT01023256|BG003|Baseline|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
10994360|NCT01023256|BG004|Baseline|Total|Total of all reporting groups
10994361|NCT01023256|FG000|Participant Flow|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994362|NCT01023256|FG001|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994363|NCT01023256|FG002|Participant Flow|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994364|NCT01023256|FG003|Participant Flow|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
10994365|NCT01023256|OG000|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994366|NCT01023256|OG001|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994367|NCT01023256|OG002|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994368|NCT01023256|OG003|Outcome|Pooled Active|All patients receiving MOR103 at any dose
10994369|NCT01023256|OG004|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
10994370|NCT01023256|OG003|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
10994371|NCT01023256|EG000|Reported Event|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994372|NCT01023256|EG001|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994373|NCT01023256|EG002|Reported Event|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
10994374|NCT01023256|EG003|Reported Event|Pooled Active|All patients receiving MOR103 at any dose
10994375|NCT01023256|EG004|Reported Event|Pooled Placebo|Pooled placebo group included all patients who were randomized to placebo in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
10994376|NCT01023269|BG000|Baseline|Total Patient|"The patient demographic were analysed without splitting by study intervention since all randomized subjects were to receive both stimulation options (ie, ON and OFF)."
10994377|NCT01023269|FG000|Participant Flow|ON / OFF|"Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.~InterStim Therapy: Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence."
10994378|NCT01023269|FG001|Participant Flow|OFF / ON|"Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.~InterStim Therapy: Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence."
10994379|NCT01023269|OG000|Outcome|All Randomized Patients|"All randomized patients have been used for the primary objective. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.~Combined groups:~group ON/OFF :Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks~group OFF/ON: Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks."
10994380|NCT01023269|EG000|Reported Event|All Enrolled Patients|Adverse events in this study were reported on the 17 enrolled patients. Due to the small number of patients in each group, the summary on adverse events was provided for the combined groups.
11348260|NCT04194151|FG003|Participant Flow|1 Minute - 2 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol
10994381|NCT01023308|BG000|Baseline|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
10994382|NCT01023308|BG001|Baseline|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
10994383|NCT01023308|BG002|Baseline|Total|Total of all reporting groups
10994384|NCT01023308|FG000|Participant Flow|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
10994385|NCT01023308|FG001|Participant Flow|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
10994386|NCT01023308|OG000|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
10994387|NCT01023308|OG001|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
10994388|NCT01023308|EG000|Reported Event|PAN+BTZ|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
10994389|NCT01023308|EG001|Reported Event|PBO+BTZ|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..
11007541|NCT01091363|OG000|Outcome|Cultural Tailoring|The 12-month prolonged abstinence was defined as being continuously abstinent from the quit day except for the first 2-week grace period. Self-reported abstinence was biochemically verified with expired-air CO (< 6 parts ppm) and saliva cotinine (≤ 30ng/ml) tests. We used a Micro+ Smokerlyzer CO Monitor (Bedfont Scientific, NJ) and NicAlert® test strips.
10994390|NCT01023477|BG000|Baseline|Chloroquine Standard Dose (500mg/Week)|"Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month standard dose chloroquine (500 mg/week).~Chloroquine Standard Dose (500mg/week): Patients will receive chloroquine (500 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.~Breast Biopsy: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery."
10994391|NCT01023477|BG001|Baseline|Chloroquine Low Dose (250mg/Week)|"Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month low dose chloroquine (250mg/week).~Chloroquine Low Dose (250mg/week): Patients will receive chloroquine (250 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.~Breast Biopsy: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery."
10994392|NCT01023477|BG002|Baseline|Total|Total of all reporting groups
10994393|NCT01023477|FG000|Participant Flow|Chloroquine Standard Dose (500mg/Week)|"Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month standard dose chloroquine (500 mg/week).~Chloroquine Standard Dose (500mg/week): Patients will receive chloroquine (500 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.~Breast Biopsy: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery."
10994394|NCT01023477|FG001|Participant Flow|Chloroquine Low Dose (250mg/Week)|"Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month low dose chloroquine (250mg/week).~Chloroquine Low Dose (250mg/week): Patients will receive chloroquine (250 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.~Breast Biopsy: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery."
10994395|NCT01023477|OG000|Outcome|Chloroquine Standard Dose (500mg/Week)|"Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month standard dose chloroquine (500 mg/week).~Chloroquine Standard Dose (500mg/week): Patients will receive chloroquine (500 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.~Breast Biopsy: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery."
10994396|NCT01023477|OG001|Outcome|Chloroquine Low Dose (250mg/Week)|"Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month low dose chloroquine (250mg/week).~Chloroquine Low Dose (250mg/week): Patients will receive chloroquine (250 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.~Breast Biopsy: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery."
10994397|NCT01023477|EG000|Reported Event|Chloroquine Standard Dose (500mg/Week)|"Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month standard dose chloroquine (500 mg/week).~Chloroquine Standard Dose (500mg/week): Patients will receive chloroquine (500 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.~Breast Biopsy: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery."
10994398|NCT01023477|EG001|Reported Event|Chloroquine Low Dose (250mg/Week)|"Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month low dose chloroquine (250mg/week).~Chloroquine Low Dose (250mg/week): Patients will receive chloroquine (250 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.~Breast Biopsy: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery."
10994399|NCT01023516|BG000|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
10994400|NCT01023516|BG001|Baseline|Placebo|Matched Placebo Tablets
10994401|NCT01023516|BG002|Baseline|Total|Total of all reporting groups
10994402|NCT01023516|FG000|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
10994403|NCT01023516|FG001|Participant Flow|Placebo|Matched Placebo Tablets
10994404|NCT01023516|OG000|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
11348261|NCT04194151|FG004|Participant Flow|1 Minute - 1,5 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol
11348262|NCT04194151|FG005|Participant Flow|1 Minute - 1 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
10994405|NCT01023516|OG001|Outcome|Placebo|Matched Placebo Tablets
10994406|NCT01023516|EG000|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
10994407|NCT01023516|EG001|Reported Event|Placebo|Matched Placebo Tablets
10994408|NCT01023568|BG000|Baseline|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
10994409|NCT01023568|BG001|Baseline|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
10994410|NCT01023568|BG002|Baseline|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
10994411|NCT01023568|BG003|Baseline|Total|Total of all reporting groups
10994412|NCT01023568|FG000|Participant Flow|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
10994413|NCT01023568|FG001|Participant Flow|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
10994414|NCT01023568|FG002|Participant Flow|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
10994415|NCT01023568|OG000|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
10994416|NCT01023568|OG001|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
10994417|NCT01023568|OG002|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
10994418|NCT01023568|EG000|Reported Event|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
10994419|NCT01023568|EG001|Reported Event|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
10994420|NCT01023568|EG002|Reported Event|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
10994421|NCT01023581|BG000|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994422|NCT01023581|BG001|Baseline|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994423|NCT01023581|BG002|Baseline|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994424|NCT01023581|BG003|Baseline|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
11223433|NCT02353299|EG003|Reported Event|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
10994425|NCT01023581|BG004|Baseline|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
10994426|NCT01023581|BG005|Baseline|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
10994427|NCT01023581|BG006|Baseline|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
10994428|NCT01023581|BG007|Baseline|Total|Total of all reporting groups
10994429|NCT01023581|FG000|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994430|NCT01023581|FG001|Participant Flow|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994431|NCT01023581|FG002|Participant Flow|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994432|NCT01023581|FG003|Participant Flow|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
10994433|NCT01023581|FG004|Participant Flow|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
10994434|NCT01023581|FG005|Participant Flow|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
10994435|NCT01023581|FG006|Participant Flow|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
10994436|NCT01023581|OG000|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994437|NCT01023581|OG001|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994438|NCT01023581|OG002|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994439|NCT01023581|OG003|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
10994440|NCT01023581|OG004|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
10994441|NCT01023581|OG005|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
10994442|NCT01023581|OG006|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
10994443|NCT01023581|EG000|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
11223434|NCT02353442|BG000|Baseline|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
10994444|NCT01023581|EG001|Reported Event|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994445|NCT01023581|EG002|Reported Event|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
10994446|NCT01023581|EG003|Reported Event|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
10994447|NCT01023581|EG004|Reported Event|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
10994448|NCT01023581|EG005|Reported Event|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
10994449|NCT01023581|EG006|Reported Event|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
10994450|NCT01023659|BG000|Baseline|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
10994451|NCT01023659|BG001|Baseline|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
10994452|NCT01023659|BG002|Baseline|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
10994453|NCT01023659|BG003|Baseline|Total|Total of all reporting groups
10994454|NCT01023659|FG000|Participant Flow|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
10994455|NCT01023659|FG001|Participant Flow|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
10994456|NCT01023659|FG002|Participant Flow|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
10994457|NCT01023659|OG000|Outcome|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
10994458|NCT01023659|OG001|Outcome|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
10994459|NCT01023659|OG002|Outcome|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
10994460|NCT01023659|OG000|Outcome|All Eligible Participants|All participants who were eligible to receive medication
10994461|NCT01023659|EG000|Reported Event|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
10994462|NCT01023659|EG001|Reported Event|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
10994463|NCT01023659|EG002|Reported Event|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
10994464|NCT01023672|BG000|Baseline|Armodifinil|150-250 mg armodafinil by mouth daily
10994465|NCT01023672|FG000|Participant Flow|Armodifinil|150-250 mg armodafinil by mouth daily
10994466|NCT01023672|OG000|Outcome|Armodifinil|150-250 mg armodafinil by mouth daily
10994467|NCT01023672|EG000|Reported Event|Armodifinil|150-250 mg armodafinil by mouth daily
10994468|NCT01023711|BG000|Baseline|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
10994469|NCT01023711|FG000|Participant Flow|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
10994470|NCT01023711|OG000|Outcome|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
10994471|NCT01023711|OG000|Outcome|Inactivated H1N1 Vaccine|Inactivated H1N1 vaccine: 0.5 ml IM into Deltoid region of arm
10994472|NCT01023711|EG000|Reported Event|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
10994473|NCT01023724|BG000|Baseline|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
10994474|NCT01023724|BG001|Baseline|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
10994475|NCT01023724|BG002|Baseline|Total|Total of all reporting groups
10994476|NCT01023724|FG000|Participant Flow|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
10994477|NCT01023724|FG001|Participant Flow|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
10994478|NCT01023724|OG000|Outcome|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
10994479|NCT01023724|OG001|Outcome|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
10994480|NCT01023724|EG000|Reported Event|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
10994481|NCT01023724|EG001|Reported Event|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
10994482|NCT01023776|BG000|Baseline|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
10994483|NCT01023776|FG000|Participant Flow|Live Monovalent H1N1 Vaccine|Subjects received 2 doses of vaccine 0.1 ml in each nostril intranasally 28 days apart
10994484|NCT01023776|OG000|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
10994485|NCT01023776|EG000|Reported Event|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
10994486|NCT01023789|BG000|Baseline|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
10994487|NCT01023789|FG000|Participant Flow|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
10994488|NCT01023789|OG000|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
10994489|NCT01023789|EG000|Reported Event|ABSORB BVS|ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
10994490|NCT01023815|BG000|Baseline|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
10994491|NCT01023815|BG001|Baseline|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
10994492|NCT01023815|BG002|Baseline|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
10994493|NCT01023815|BG003|Baseline|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
10994494|NCT01023815|BG004|Baseline|Total|Total of all reporting groups
10994495|NCT01023815|FG000|Participant Flow|Pre-randomized: Not-randomization Patients (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
10994496|NCT01023815|FG001|Participant Flow|Randomized: Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
10994497|NCT01023815|FG002|Participant Flow|Randomized: Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
10994498|NCT01023815|FG003|Participant Flow|Randomized: Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
11007542|NCT01091363|OG001|Outcome|Brief Cessation Counseling|The 12-month prolonged abstinence was defined as being continuously abstinent from the quit day except for the first 2-week grace period. Self-reported abstinence was biochemically verified with expired-air CO (< 6 parts ppm) and saliva cotinine (≤ 30ng/ml) tests. We used a Micro+ Smokerlyzer CO Monitor (Bedfont Scientific, NJ) and NicAlert® test strips.
11007543|NCT01091363|EG000|Reported Event|Cultural Tailoring|The group who received a deep Korean-culture tailored smoking cessation intervention.
11007544|NCT01091363|EG001|Reported Event|Brief Cessation Counseling|The group who received a standard non-culture tailored smoking cessation intervention.
11348263|NCT04194151|OG000|Outcome|2 Minute - 2 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol
10994499|NCT01023815|OG000|Outcome|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
10994500|NCT01023815|OG001|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
10994501|NCT01023815|OG002|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
10994502|NCT01023815|OG000|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
10994503|NCT01023815|OG001|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
10994504|NCT01023815|EG000|Reported Event|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~This population defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP) and described with respect to baseline characteristics, treatment and outcome variables."
10994505|NCT01023815|EG001|Reported Event|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
10994506|NCT01023815|EG002|Reported Event|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
10994507|NCT01023815|EG003|Reported Event|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
10994508|NCT01023841|BG000|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
10994509|NCT01023841|BG001|Baseline|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
10994510|NCT01023841|BG002|Baseline|Total|Total of all reporting groups
10994511|NCT01023841|FG000|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
10994512|NCT01023841|FG001|Participant Flow|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
10994513|NCT01023841|OG000|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
10994514|NCT01023841|OG001|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
10994515|NCT01023841|EG000|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
10994516|NCT01023841|EG001|Reported Event|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
10994517|NCT01023958|BG000|Baseline|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
10994518|NCT01023958|FG000|Participant Flow|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
10994519|NCT01023958|OG000|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
10994520|NCT01023958|EG000|Reported Event|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
10994521|NCT01024010|BG000|Baseline|Arm A: PCO|"Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.~During cycles 1-6, patients also receive 2 mg/m^2 pentostatin IV over 30 minutes on day 1, 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2."
10994522|NCT01024010|BG001|Baseline|Arm B: PCO +O|"Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.~During cycles1-6, patients also receive 2 mg/m^2 pentostatin IV over 30 minutes on day 1, 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.~For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1."
10994523|NCT01024010|BG002|Baseline|Total|Total of all reporting groups
10994524|NCT01024010|FG000|Participant Flow|Arm A: PCO|"Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.~During cycles 1-6, patients also receive 2 mg/m^2 pentostatin IV over 30 minutes on day 1, 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2."
10994525|NCT01024010|FG001|Participant Flow|Arm B: PCO +O|"Patients receive 300 mg ofatumumab IV on day 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.~During cycles1-6, patients also receive 2 mg/m^2 pentostatin IV over 30 minutes on day 1, 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.~For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1."
10994526|NCT01024010|OG000|Outcome|Arm A: PCO|"Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.~During cycles 1-6, patients also receive 2 mg/m^2 pentostatin IV over 30 minutes on day 1, 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2."
10994527|NCT01024010|OG001|Outcome|Arm B: PCO +O|"Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.~During cycles1-6, patients also receive 2 mg/m^2 pentostatin IV over 30 minutes on day 1, 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.~For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1."
10994528|NCT01024010|EG000|Reported Event|Arm A: PCO|"Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.~During cycles 1-6, patients also receive 2 mg/m^2 pentostatin IV over 30 minutes on day 1, 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2."
10994529|NCT01024010|EG001|Reported Event|Arm B: PCO +O|"Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.~During cycles1-6, patients also receive 2 mg/m^2 pentostatin IV over 30 minutes on day 1, 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.~For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1."
10994530|NCT01024036|BG000|Baseline|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant's treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
10994531|NCT01024036|BG001|Baseline|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
10994532|NCT01024036|BG002|Baseline|Total|Total of all reporting groups
10994533|NCT01024036|FG000|Participant Flow|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
10994534|NCT01024036|FG001|Participant Flow|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant's treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
10994535|NCT01024036|OG000|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant's treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
10994536|NCT01024036|OG001|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
10994537|NCT01024036|EG000|Reported Event|Placebo + Best Supportive Care (BSC) (Blinded)|Participants received placebo as a 1-hour intravenous infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last participant started study treatment, whichever occurred earlier. Participants who discontinued or completed treatment period up to Week 48, and who consented to enter the follow-up period were continued to be followed up during the course of follow-up period.
10994538|NCT01024036|EG001|Reported Event|Siltuximab + Best Supportive Care (BSC) (Blinded)|Participants received siltuximab 11mg/kg as a 1-hour intravenous infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason completed the end-of-treatment visit and entered the follow-up period.
10994539|NCT01024036|EG002|Reported Event|Siltuximab + Best Supportive Care (BSC) (Unblinded)|Participants who had documented treatment failure and wished to continue treatment, their treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab during the unblinded treatment period.
10994540|NCT01024036|EG003|Reported Event|Placebo + BSC (Follow-up Period)|No study treatment was administered during the follow-up period (up to 3 months after last study agent administration [placebo as a 1 hour IV infusion every 3 weeks along with BSC]) and participants were followed until death, lost to follow up, withdrawal of consent, death of 50 % of participants, or the end of the study, whichever occurred earlier.
11223435|NCT02353442|BG001|Baseline|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
11223436|NCT02353442|BG002|Baseline|Total|Total of all reporting groups
11348264|NCT04194151|OG001|Outcome|2 Minute - 1,5 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol
11223437|NCT02353442|FG000|Participant Flow|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
11348265|NCT04194151|OG002|Outcome|2 Minute - 1 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol
10994541|NCT01024036|EG004|Reported Event|Siltuximab + BSC (Follow-up Period)|No study treatment was administered during the follow-up period (up to 3 months after last study agent administration [siltuximab 11mg/kg as a 1 hour IV infusion every 3 weeks along with ]) and participants were followed until death, lost to follow up, withdrawal of consent, death of 50 % of participants, or the end of the study, whichever occurred earlier.
10994542|NCT01024231|BG000|Baseline|Cohort 1|0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994543|NCT01024231|BG001|Baseline|Cohort 2|1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994544|NCT01024231|BG002|Baseline|Cohort 2a|3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
10994545|NCT01024231|BG003|Baseline|Cohort 3|3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994546|NCT01024231|BG004|Baseline|Cohort 6|1mg/kg of BMS-936558 (MDX-1106)
10994547|NCT01024231|BG005|Baseline|Cohorot 7|3 mg/kg of BMS-936558 (MDX-1106)
10994548|NCT01024231|BG006|Baseline|Cohort 8|1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses
10994549|NCT01024231|BG007|Baseline|Total|Total of all reporting groups
10994550|NCT01024231|FG000|Participant Flow|Cohort 1|0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994551|NCT01024231|FG001|Participant Flow|Cohort 2|1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994552|NCT01024231|FG002|Participant Flow|Cohort 2a|3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
10994553|NCT01024231|FG003|Participant Flow|Cohort 3|3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994554|NCT01024231|FG004|Participant Flow|Cohort 6|1mg/kg of BMS-936558 (MDX-1106)
10994555|NCT01024231|FG005|Participant Flow|Cohorot 7|3 mg/kg of BMS-936558 (MDX-1106)
10994556|NCT01024231|FG006|Participant Flow|Cohort 8|1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses
10994557|NCT01024231|OG000|Outcome|Cohort 1|0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994558|NCT01024231|OG001|Outcome|Cohort 2|1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994559|NCT01024231|OG002|Outcome|Cohort 2a|3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
10994560|NCT01024231|OG003|Outcome|Cohort 3|3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994561|NCT01024231|OG004|Outcome|Any BMS and Ipi Combo|All participants who received treatment in Cohorts 1 through 3
10994562|NCT01024231|OG005|Outcome|Cohort 6|1mg/kg of BMS-936558 (MDX-1106)
10994563|NCT01024231|OG006|Outcome|Cohorot 7|3 mg/kg of BMS-936558 (MDX-1106)
10994564|NCT01024231|OG007|Outcome|Only BMS|combined total of participants who receive BMS only
10994565|NCT01024231|OG008|Outcome|Cohort 8|1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses
10994566|NCT01024231|OG009|Outcome|Any BMS/Ipi|All participants who received both BMS and Ipi
10994567|NCT01024231|OG010|Outcome|Total|All Participants who received treatment in any cohort combined
10994568|NCT01024231|OG007|Outcome|Only BMS|Combined total of participants who receive BMS only
10994569|NCT01024231|EG000|Reported Event|Cohort 1|0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994570|NCT01024231|EG001|Reported Event|Cohort 2|1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994571|NCT01024231|EG002|Reported Event|Cohort 2a|3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
10994572|NCT01024231|EG003|Reported Event|Cohort 3|3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
10994573|NCT01024231|EG004|Reported Event|Cohort 6|1mg/kg of BMS-936558 (MDX-1106)
10994574|NCT01024231|EG005|Reported Event|Cohorot 7|3 mg/kg of BMS-936558 (MDX-1106)
10994575|NCT01024231|EG006|Reported Event|Cohort 8|1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses
10994576|NCT01024244|BG000|Baseline|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
10994577|NCT01024244|BG001|Baseline|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
10994578|NCT01024244|BG002|Baseline|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
10994579|NCT01024244|BG003|Baseline|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
10994580|NCT01024244|BG004|Baseline|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
10994581|NCT01024244|BG005|Baseline|Total|Total of all reporting groups
10994582|NCT01024244|FG000|Participant Flow|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
10994583|NCT01024244|FG001|Participant Flow|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
10994584|NCT01024244|FG002|Participant Flow|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
10994585|NCT01024244|FG003|Participant Flow|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
10994586|NCT01024244|FG004|Participant Flow|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
10994587|NCT01024244|OG000|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
10994588|NCT01024244|OG001|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
10994589|NCT01024244|OG002|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
11223438|NCT02353442|FG001|Participant Flow|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
11223439|NCT02353442|OG000|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
11223440|NCT02353442|OG001|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
11348266|NCT04194151|OG003|Outcome|1 Minute - 2 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol
10877035|NCT00445224|EG000|Reported Event|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
10877036|NCT00445224|EG001|Reported Event|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
10877037|NCT00445263|BG000|Baseline|Early Invasive Strategy|Tirofiban and coronarography within six hours
10877038|NCT00445263|BG001|Baseline|Delayed Invasive Strategy|Coronarography after six hours
10877039|NCT00445263|BG002|Baseline|Total|Total of all reporting groups
10877040|NCT00445263|FG000|Participant Flow|Early Invasive Strategy|Tirofiban and coronarography within six hours
10877041|NCT00445263|FG001|Participant Flow|Delayed Invasive Strategy|Coronarography after six hours
10877042|NCT00445263|OG000|Outcome|Early Invasive Strategy|Tirofiban and coronarography within six hours
10877043|NCT00445263|OG001|Outcome|Delayed Invasive Strategy|Coronarography after six hours
10877044|NCT00445263|EG000|Reported Event|Early Invasive Strategy|Tirofiban and coronarography within six hours
10877045|NCT00445263|EG001|Reported Event|Delayed Invasive Strategy|Coronarography after six hours
10877046|NCT00445302|BG000|Baseline|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877047|NCT00445302|BG001|Baseline|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877048|NCT00445302|BG002|Baseline|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877049|NCT00445302|BG003|Baseline|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877050|NCT00445302|BG004|Baseline|Total|Total of all reporting groups
10877051|NCT00445302|FG000|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877052|NCT00445302|FG001|Participant Flow|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877053|NCT00445302|FG002|Participant Flow|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877054|NCT00445302|FG003|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877055|NCT00445302|OG000|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877056|NCT00445302|OG001|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877057|NCT00445302|OG002|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877058|NCT00445302|OG003|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877059|NCT00445302|EG000|Reported Event|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877060|NCT00445302|EG001|Reported Event|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877061|NCT00445302|EG002|Reported Event|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877062|NCT00445302|EG003|Reported Event|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
10877063|NCT00445315|BG000|Baseline|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
11223441|NCT02353442|EG000|Reported Event|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
11223442|NCT02353442|EG001|Reported Event|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
11223443|NCT02353754|BG000|Baseline|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
11223444|NCT02353754|BG001|Baseline|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
11223445|NCT02353754|BG002|Baseline|Total|Total of all reporting groups
11223446|NCT02353754|FG000|Participant Flow|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
11223447|NCT02353754|FG001|Participant Flow|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
10994590|NCT01024244|OG003|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
10994591|NCT01024244|OG004|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
11223448|NCT02353754|OG000|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
11223449|NCT02353754|OG001|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
11223450|NCT02353754|EG000|Reported Event|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
11223451|NCT02353754|EG001|Reported Event|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
11223452|NCT02353780|BG000|Baseline|Different TNF Inhibitor|"The participant will be prescribed any TNF antagonist in this arm. The treating rheumatologist selects the TNF antagonist and the appropriate options for that therapy.~TNF Antagonist (enbrel, humire, remicade, cimzia, symponi): TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen."
11223453|NCT02353780|BG001|Baseline|Abatacept|"The participant will be prescribed abatacept in this arm. The treating rheumatologist selects the appropriate options for that therapy.~Abatacept: Abatacept; SQ; specifics to be determined by the treating rheumatologist."
11223454|NCT02353780|BG002|Baseline|Tocilizumab|"The participant will be prescribed tocilizumab. The treating rheumatologist selects the appropriate options for that therapy.~Tocilizumab: Tocilizumab; SQ; specifics determined by the treating rheumatologist."
11223455|NCT02353780|BG003|Baseline|Total|Total of all reporting groups
10994592|NCT01024244|EG000|Reported Event|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
10994593|NCT01024244|EG001|Reported Event|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
10994594|NCT01024244|EG002|Reported Event|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
10994595|NCT01024244|EG003|Reported Event|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
11223456|NCT02353780|FG000|Participant Flow|Different TNF Inhibitor|"The participant will be prescribed any TNF antagonist in this arm. The treating rheumatologist selects the TNF antagonist and the appropriate options for that therapy.~TNF Antagonist (enbrel, humire, remicade, cimzia, symponi): TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen."
11223457|NCT02353780|FG001|Participant Flow|Abatacept|"The participant will be prescribed abatacept in this arm. The treating rheumatologist selects the appropriate options for that therapy.~Abatacept: Abatacept; SQ; specifics to be determined by the treating rheumatologist."
11223458|NCT02353780|FG002|Participant Flow|Tocilizumab|"The participant will be prescribed tocilizumab. The treating rheumatologist selects the appropriate options for that therapy.~Tocilizumab: Tocilizumab; SQ; specifics determined by the treating rheumatologist."
11223459|NCT02353780|OG000|Outcome|Different TNF Inhibitor|"The participant will be prescribed any TNF antagonist in this arm. The treating rheumatologist selects the TNF antagonist and the appropriate options for that therapy.~TNF Antagonist (enbrel, humire, remicade, cimzia, symponi): TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen."
11223460|NCT02353780|OG001|Outcome|Abatacept|"The participant will be prescribed abatacept in this arm. The treating rheumatologist selects the appropriate options for that therapy.~Abatacept: Abatacept; SQ; specifics to be determined by the treating rheumatologist."
11223461|NCT02353780|OG002|Outcome|Tocilizumab|"The participant will be prescribed tocilizumab. The treating rheumatologist selects the appropriate options for that therapy.~Tocilizumab: Tocilizumab; SQ; specifics determined by the treating rheumatologist."
11223462|NCT02353780|EG000|Reported Event|Different TNF Inhibitor|"The participant will be prescribed any TNF antagonist in this arm. The treating rheumatologist selects the TNF antagonist and the appropriate options for that therapy.~TNF Antagonist (enbrel, humire, remicade, cimzia, symponi): TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen."
11223463|NCT02353780|EG001|Reported Event|Abatacept|"The participant will be prescribed abatacept in this arm. The treating rheumatologist selects the appropriate options for that therapy.~Abatacept: Abatacept; SQ; specifics to be determined by the treating rheumatologist."
11223464|NCT02353780|EG002|Reported Event|Tocilizumab|"The participant will be prescribed tocilizumab. The treating rheumatologist selects the appropriate options for that therapy.~Tocilizumab: Tocilizumab; SQ; specifics determined by the treating rheumatologist."
11223465|NCT02353806|BG000|Baseline|Pregnant Women Taking Amlodipine|"Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm.~Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician."
11223466|NCT02353806|FG000|Participant Flow|Pregnant Women Taking Amlodipine|"Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm.~Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician."
11223467|NCT02353806|OG000|Outcome|Pregnant Women Taking Amlodipine|"Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm.~Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician."
11223468|NCT02353806|OG000|Outcome|Infant's Born to Women Taking Amlodipine Besylate|"Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.~Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician."
10877064|NCT00445315|BG001|Baseline|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877065|NCT00445315|BG002|Baseline|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
10877066|NCT00445315|BG003|Baseline|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877067|NCT00445315|BG004|Baseline|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
10877068|NCT00445315|BG005|Baseline|Total|Total of all reporting groups
10877069|NCT00445315|FG000|Participant Flow|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877070|NCT00445315|FG001|Participant Flow|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877071|NCT00445315|FG002|Participant Flow|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
10877072|NCT00445315|FG003|Participant Flow|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877073|NCT00445315|FG004|Participant Flow|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
10877074|NCT00445315|OG000|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
11223469|NCT02353806|OG000|Outcome|Infant's Born to Women Taking Amlodipine Besylate|Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.
10877075|NCT00445315|OG001|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877076|NCT00445315|OG002|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
10877077|NCT00445315|OG003|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
11223470|NCT02353806|EG000|Reported Event|Pregnant Women Taking Amlodipine|"Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm.~Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician."
11223471|NCT02353871|BG000|Baseline|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
11223472|NCT02353871|BG001|Baseline|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
11223473|NCT02353871|BG002|Baseline|Total|Total of all reporting groups
11223474|NCT02353871|FG000|Participant Flow|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
10994596|NCT01024244|EG004|Reported Event|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
10994597|NCT01024296|BG000|Baseline|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
10994598|NCT01024296|FG000|Participant Flow|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
10994599|NCT01024296|OG000|Outcome|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
10994600|NCT01024296|EG000|Reported Event|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
10994601|NCT01024309|BG000|Baseline|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
10994602|NCT01024309|BG001|Baseline|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
10994603|NCT01024309|BG002|Baseline|Total|Total of all reporting groups
10994604|NCT01024309|FG000|Participant Flow|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
10994605|NCT01024309|FG001|Participant Flow|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
10994606|NCT01024309|OG000|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
10994607|NCT01024309|OG001|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
10994608|NCT01024309|EG000|Reported Event|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty: Mini-Posterior surgical approach for total hip arthroplasty
10994609|NCT01024309|EG001|Reported Event|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty: Direct Anterior surgical approach for total hip arthroplasty
10994610|NCT01024335|BG000|Baseline|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
10994611|NCT01024335|BG001|Baseline|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
10994612|NCT01024335|BG002|Baseline|Total|Total of all reporting groups
10994613|NCT01024335|FG000|Participant Flow|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
10994614|NCT01024335|FG001|Participant Flow|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
10994615|NCT01024335|OG000|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
10994616|NCT01024335|OG001|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
10994617|NCT01024335|EG000|Reported Event|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
10994618|NCT01024335|EG001|Reported Event|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
10994619|NCT01024387|BG000|Baseline|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
10994620|NCT01024387|FG000|Participant Flow|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
10994621|NCT01024387|OG000|Outcome|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
10994622|NCT01024387|EG000|Reported Event|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
10994623|NCT01024465|BG000|Baseline|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
10994624|NCT01024465|FG000|Participant Flow|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
10994625|NCT01024465|OG000|Outcome|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
10994626|NCT01024465|EG000|Reported Event|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
10994627|NCT01024569|BG000|Baseline|Wellness Recovery Action Planning (WRAP)|"WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks. Topics include: Introduction to WRAP, Developing a Wellness Toolbox, Creating a Daily Maintenance Plan, Identifying Triggers, Identifying Early Warning Signs, Managing When Things Break Down, and Crisis Planning. Coursework is interactive, using lecture, question and answer, group discussion, and individual or group exercises. Each session includes a lecture on recovery topics such as self-esteem, changing negative thoughts to positive ones, peer support, and lifestyle issues.~Wellness Recovery Action Planning (WRAP): WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks."
10994628|NCT01024569|BG001|Baseline|Comparison Wait-List Group|Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend WRAP groups after their final research interview.
10994629|NCT01024569|BG002|Baseline|Total|Total of all reporting groups
10994630|NCT01024569|FG000|Participant Flow|Wellness Recovery Action Planning (WRAP)|"WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks. Topics include: Introduction to WRAP, Developing a Wellness Toolbox, Creating a Daily Maintenance Plan, Identifying Triggers, Identifying Early Warning Signs, Managing When Things Break Down, and Crisis Planning. Coursework is interactive, using lecture, question and answer, group discussion, and individual or group exercises. Each session includes a lecture on recovery topics such as self-esteem, changing negative thoughts to positive ones, peer support, and lifestyle issues.~Wellness Recovery Action Planning (WRAP): WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks."
10994631|NCT01024569|FG001|Participant Flow|Comparison Wait-List Group|Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend WRAP groups after their final research interview.
10994632|NCT01024569|OG000|Outcome|Experimental|Received intervention
10994633|NCT01024569|OG001|Outcome|Control|Did not receive intervention
10994634|NCT01024569|OG000|Outcome|Wellness Recovery Action Planning (WRAP)|"WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks. Topics include: Introduction to WRAP, Developing a Wellness Toolbox, Creating a Daily Maintenance Plan, Identifying Triggers, Identifying Early Warning Signs, Managing When Things Break Down, and Crisis Planning. Coursework is interactive, using lecture, question and answer, group discussion, and individual or group exercises. Each session includes a lecture on recovery topics such as self-esteem, changing negative thoughts to positive ones, peer support, and lifestyle issues.~Wellness Recovery Action Planning (WRAP): WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks."
10994635|NCT01024569|OG001|Outcome|Comparison Wait-List Group|Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend WRAP groups after their final research interview.
10994636|NCT01024569|EG000|Reported Event|Wellness Recovery Action Planning (WRAP)|"WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks. Topics include: Introduction to WRAP, Developing a Wellness Toolbox, Creating a Daily Maintenance Plan, Identifying Triggers, Identifying Early Warning Signs, Managing When Things Break Down, and Crisis Planning. Coursework is interactive, using lecture, question and answer, group discussion, and individual or group exercises. Each session includes a lecture on recovery topics such as self-esteem, changing negative thoughts to positive ones, peer support, and lifestyle issues.~Wellness Recovery Action Planning (WRAP): WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks."
10994637|NCT01024569|EG001|Reported Event|Comparison Wait-List Group|Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend WRAP groups after their final research interview.
10994638|NCT01024686|BG000|Baseline|p52-p36- GAP Vaccine|"p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito.~p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito.~Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum."
10994639|NCT01024686|BG001|Baseline|Infectivity Control|Active Control: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
10994640|NCT01024686|BG002|Baseline|p52-p36- GAP Vaccine + Infectivity Challenge|"p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito.~Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum."
10994641|NCT01024686|BG003|Baseline|Total|Total of all reporting groups
10994642|NCT01024686|FG000|Participant Flow|p52-p36- GAP Vaccine|"p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito.~p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito.~Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum."
10994643|NCT01024686|FG001|Participant Flow|Infectivity Control|Active Control: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum
11223475|NCT02353871|FG001|Participant Flow|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
11223476|NCT02353871|OG000|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
10994644|NCT01024686|FG002|Participant Flow|p52-p36- GAP Vaccine + Infectivity Challenge|"p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito~Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum."
10994645|NCT01024686|OG000|Outcome|p52-p36- GAP Vaccine|"p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito~p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito"
10994646|NCT01024686|OG001|Outcome|Infectivity Control|
10994647|NCT01024686|OG002|Outcome|p52-p36- GAP Vaccine + Infectivity Challenge|p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
10994648|NCT01024686|EG000|Reported Event|p52-p36- GAP Vaccine|"p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito.~p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito.~Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum."
10994649|NCT01024686|EG001|Reported Event|Infectivity Control|Active Control: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
11223477|NCT02353871|OG001|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
11223478|NCT02353871|EG000|Reported Event|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
11223479|NCT02353871|EG001|Reported Event|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
11223480|NCT02354092|BG000|Baseline|Sham Group|"This non-intervention group will receive the sham paracervical block. This intervention will include~Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement~Local anesthetic for tenaculum placement~Sham Paracervical Block done with capped spinal needle~osmotic dilators placed in the usual fashion~postprocedural assessment"
11223481|NCT02354092|BG001|Baseline|Paracervical Block Group|"This intervention group will receive the paracervical block. This intervention will include~Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement~Local anesthetic for tenaculum placement~18 ml 1% buffered lidocaine Paracervical Block~osmotic dilators placed in the usual fashion~postprocedural assessment"
11223482|NCT02354092|BG002|Baseline|Total|Total of all reporting groups
11348267|NCT04194151|OG004|Outcome|1 Minute - 1,5 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol
10994650|NCT01024686|EG002|Reported Event|p52-p36- GAP Vaccine + Infectivity Challenge|"p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito~Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum."
10994651|NCT01024738|BG000|Baseline|Fluoride Toothpaste|negative control toothpaste
10994652|NCT01024738|BG001|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
10994653|NCT01024738|BG002|Baseline|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
10994654|NCT01024738|BG003|Baseline|Total|Total of all reporting groups
10994655|NCT01024738|FG000|Participant Flow|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
10994656|NCT01024738|FG001|Participant Flow|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
10994657|NCT01024738|FG002|Participant Flow|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
10994658|NCT01024738|OG000|Outcome|Fluoride Toothpaste|negative control toothpaste
10994659|NCT01024738|OG001|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
10994660|NCT01024738|OG002|Outcome|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
10994661|NCT01024738|EG000|Reported Event|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
10994662|NCT01024738|EG001|Reported Event|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
10994663|NCT01024738|EG002|Reported Event|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
11223483|NCT02354092|FG000|Participant Flow|Sham Group|"This non-intervention group will receive the sham paracervical block. This intervention will include~Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement~Local anesthetic for tenaculum placement~Sham Paracervical Block done with capped spinal needle~osmotic dilators placed in the usual fashion~postprocedural assessment"
11223484|NCT02354092|FG001|Participant Flow|Paracervical Block Group|"This intervention group will receive the paracervical block. This intervention will include~Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement~Local anesthetic for tenaculum placement~18 ml 1% buffered lidocaine Paracervical Block~osmotic dilators placed in the usual fashion~postprocedural assessment"
11223485|NCT02354092|OG000|Outcome|Sham Group|"This non-intervention group will receive the sham paracervical block. This intervention will include~Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement~Local anesthetic for tenaculum placement~Sham Paracervical Block done with capped spinal needle~osmotic dilators placed in the usual fashion~postprocedural assessment"
11223486|NCT02354092|OG001|Outcome|Paracervical Block Group|"This intervention group will receive the paracervical block. This intervention will include~Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement~Local anesthetic for tenaculum placement~18 ml 1% buffered lidocaine Paracervical Block~osmotic dilators placed in the usual fashion~postprocedural assessment"
11223487|NCT02354092|EG000|Reported Event|Sham Group|"This non-intervention group will receive the sham paracervical block. This intervention will include~Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement~Local anesthetic for tenaculum placement~Sham Paracervical Block done with capped spinal needle~osmotic dilators placed in the usual fashion~postprocedural assessment"
10994664|NCT01024751|BG000|Baseline|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
10994665|NCT01024751|BG001|Baseline|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
10994666|NCT01024751|BG002|Baseline|Total|Total of all reporting groups
10994667|NCT01024751|FG000|Participant Flow|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
10994668|NCT01024751|FG001|Participant Flow|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
10994669|NCT01024751|OG000|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
10994670|NCT01024751|OG001|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
10994671|NCT01024751|EG000|Reported Event|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
10994672|NCT01024751|EG001|Reported Event|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
10994673|NCT01024855|BG000|Baseline|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
10994674|NCT01024855|FG000|Participant Flow|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
10994675|NCT01024855|OG000|Outcome|RevitaLens|30 subjects, one eye received RevitaLens MPS (investigational).
10994676|NCT01024855|OG001|Outcome|OptiFree|30 subjects, one eye received Opti-Free RepleniSH MPS(control).
10994677|NCT01024855|EG000|Reported Event|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
10994678|NCT01024920|BG000|Baseline|Nintedanib (BIBF 1120)|Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.
10994679|NCT01024920|BG001|Baseline|Sunitinib|Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.
10994680|NCT01024920|BG002|Baseline|Total|Total of all reporting groups
10994681|NCT01024920|FG000|Participant Flow|Nintedanib (BIBF 1120)|Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.
10994682|NCT01024920|FG001|Participant Flow|Sunitinib|Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.
10994683|NCT01024920|OG000|Outcome|Nintedanib (BIBF 1120)|Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.
10994684|NCT01024920|OG001|Outcome|Sunitinib|Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.
10994685|NCT01024920|EG000|Reported Event|Nintedanib (BIBF 1120)|Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.
10994686|NCT01024920|EG001|Reported Event|Sunitinib|Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.
10994687|NCT01024946|BG000|Baseline|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
11007545|NCT01091428|BG000|Baseline|Alisertib (Phase 1 - Ovarian Cancer)|Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).
10994688|NCT01024946|FG000|Participant Flow|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
10994689|NCT01024946|OG000|Outcome|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
10994690|NCT01024946|EG000|Reported Event|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
10994691|NCT01024959|BG000|Baseline|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
10994692|NCT01024959|FG000|Participant Flow|Prostate Cancer Gene 3 (PCA3) Assay|PCA3 Assay : Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
10994693|NCT01024959|OG000|Outcome|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
10994694|NCT01024959|OG001|Outcome|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
10994695|NCT01024959|OG002|Outcome|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
10994696|NCT01024959|EG000|Reported Event|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
10994697|NCT01024959|EG001|Reported Event|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
10994698|NCT01024959|EG002|Reported Event|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
10994699|NCT01024959|EG003|Reported Event|Subjects With no Biopsy Performed|
10994700|NCT01024972|BG000|Baseline|Dantrolene|Intravenous Datrolene 1.25 mg/kg (includes 5% mannitol) every 6 hours for seven days.
10994701|NCT01024972|BG001|Baseline|Placebo|Equiosmolar volume (5% mannitol) every 6 hours for seven days.
10994702|NCT01024972|BG002|Baseline|Total|Total of all reporting groups
10994703|NCT01024972|FG000|Participant Flow|Dantrolene|"Dantrolene 1.25mg/kg IV every 6 hours x 7 days~Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
10994704|NCT01024972|FG001|Participant Flow|Placebo|"Equiosmolar volume (5% Mannitol)~Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
10994705|NCT01024972|OG000|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
10994706|NCT01024972|OG001|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days.
10994707|NCT01024972|OG001|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
10994708|NCT01024972|EG000|Reported Event|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
10994709|NCT01024972|EG001|Reported Event|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
10994710|NCT01025037|BG000|Baseline|Conexa|Rotator cuff repair using Conexa
10994711|NCT01025037|FG000|Participant Flow|Conexa|Rotator cuff repair using Conexa
10994712|NCT01025037|OG000|Outcome|Conexa|Rotator cuff repair using Conexa
10994713|NCT01025037|EG000|Reported Event|Conexa|Rotator cuff repair using Conexa
11007546|NCT01091428|BG001|Baseline|Alisertib (Phase 1 - Breast Cancer)|Participants with breast cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).
11007547|NCT01091428|BG002|Baseline|Alisertib 40 mg BID+ Paclitaxel 60 mg/m^2 (Phase 2)|Alisertib 40 mg, orally, BID on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2 (Up to 28 cycles).
10994714|NCT01025076|BG000|Baseline|StomaphX|Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic
10994715|NCT01025076|FG000|Participant Flow|StomaphX|
10994716|NCT01025076|OG000|Outcome|StomaphX|
10994717|NCT01025076|EG000|Reported Event|StomaphX|
10994718|NCT01025154|BG000|Baseline|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
10994719|NCT01025154|FG000|Participant Flow|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
10994720|NCT01025154|OG000|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
10994721|NCT01025154|EG000|Reported Event|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
10994722|NCT01025193|BG000|Baseline|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used in to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
10994723|NCT01025193|FG000|Participant Flow|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was being used to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
10994724|NCT01025193|OG000|Outcome|Belimumab|"Belimumab will be administered intravenously at a dose of 10mg/kg on days 0, 14, 28 and every 28 days for up to 52 weeks to normalize alloantibody levels in sensitized patients awaiting kidney transplantation. Subjects who are not able to undergo transplantation before the end of the treatment period will have final follow-up evaluation 8 weeks after the last dose of belimumab is administered.~Belimumab: Belimumab is a fully human monoclonal antibody that recognizes and inhibits BLyS ®. BLyS ® is a B-lymphocyte stimulator protein which plays a role in the development of B lymphocyte cells into plasma B cells, which then produce antibodies that can sensitize a potential transplant recipient. At the time of this trial, belimumab was not yet FDA approved and was being studied in clinical trials for the treatment of systemic lupus erythematosus. Until this trial, it had not yet been used in the transplant setting."
10994725|NCT01025193|OG000|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
10994726|NCT01025193|OG000|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
10994727|NCT01025193|OG000|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).~Belimumab: The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
10994728|NCT01025193|OG000|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used in to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
10994729|NCT01025193|EG000|Reported Event|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the patient waiting for kidney transplant's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
10994730|NCT01025232|BG000|Baseline|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
10994731|NCT01025232|BG001|Baseline|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
10994732|NCT01025232|BG002|Baseline|Total|Total of all reporting groups
10994733|NCT01025232|FG000|Participant Flow|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
10994734|NCT01025232|FG001|Participant Flow|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
10994735|NCT01025232|OG000|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
10994736|NCT01025232|OG001|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
10994737|NCT01025232|EG000|Reported Event|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
10994738|NCT01025232|EG001|Reported Event|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
10994739|NCT01025284|BG000|Baseline|Part A - 8 mg/m²/Day|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
10994740|NCT01025284|BG001|Baseline|Part B - 5 mg/m²/Day|5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
10994741|NCT01025284|BG002|Baseline|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
11223488|NCT02354092|EG001|Reported Event|Paracervical Block Group|"This intervention group will receive the paracervical block. This intervention will include~Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement~Local anesthetic for tenaculum placement~18 ml 1% buffered lidocaine Paracervical Block~osmotic dilators placed in the usual fashion~postprocedural assessment"
10994742|NCT01025284|BG003|Baseline|Total|Total of all reporting groups
10994743|NCT01025284|FG000|Participant Flow|Part A - 8 mg/m²/Day|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
10994744|NCT01025284|FG001|Participant Flow|Part B - 5 mg/m²/Day|5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
10994745|NCT01025284|FG002|Participant Flow|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
11348268|NCT04194151|OG005|Outcome|1 Minute - 1 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
11336446|NCT03566810|FG000|Participant Flow|First Test GXR (Fasting), Then Reference GXR (Fasting)|Participants received a single oral dose of 500 milligrams (mg) of test GXR tablet (Merck Nantong, China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GXR (Merck Darmstadt, Germany) on Day 8 in treatment period 2 under fasting conditions. There was a wash-out period of 7 days between each treatment period.
10994746|NCT01025284|OG000|Outcome|Part A|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
10994747|NCT01025284|OG000|Outcome|Part B|5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
10994748|NCT01025284|OG000|Outcome|Part B - 5 mg/m²/Day|5 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
10994749|NCT01025284|OG001|Outcome|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
10994750|NCT01025284|OG001|Outcome|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
10994751|NCT01025284|EG000|Reported Event|Part A - 8 mg/m²/Day|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
10994752|NCT01025284|EG001|Reported Event|Part B - 5 mg/m²/Day|5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
10994753|NCT01025284|EG002|Reported Event|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
10994754|NCT01025336|BG000|Baseline|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994755|NCT01025336|BG001|Baseline|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994756|NCT01025336|BG002|Baseline|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994757|NCT01025336|BG003|Baseline|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994758|NCT01025336|BG004|Baseline|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994759|NCT01025336|BG005|Baseline|Total|Total of all reporting groups
10994760|NCT01025336|FG000|Participant Flow|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994761|NCT01025336|FG001|Participant Flow|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994762|NCT01025336|FG002|Participant Flow|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994763|NCT01025336|FG003|Participant Flow|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994764|NCT01025336|FG004|Participant Flow|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994765|NCT01025336|OG000|Outcome|13vPnC/13vPnC Group (23vPs Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994766|NCT01025336|OG001|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994767|NCT01025336|OG002|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994768|NCT01025336|OG000|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994769|NCT01025336|OG001|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994770|NCT01025336|OG000|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)and at Year 1 (Vaccination 2)
10994771|NCT01025336|OG001|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994772|NCT01025336|OG000|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994773|NCT01025336|OG000|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994774|NCT01025336|OG001|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994775|NCT01025336|OG001|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2).
10994776|NCT01025336|OG000|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994777|NCT01025336|OG001|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and either 13vPnC or 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) (both 13vPnC/13vPnC and 13vPnC/23vPS dose groups)
10994778|NCT01025336|OG000|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994779|NCT01025336|OG001|Outcome|13vPnC (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
10994780|NCT01025336|OG000|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
10994781|NCT01025336|OG001|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (6115A1-3010 NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
10994782|NCT01025336|EG000|Reported Event|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994783|NCT01025336|EG001|Reported Event|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
11007548|NCT01091428|BG003|Baseline|Paclitaxel 80 mg/m^2 (Phase 2)|Paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2 (Up to 28 cycles).
10994784|NCT01025336|EG002|Reported Event|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994785|NCT01025336|EG003|Reported Event|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
10994786|NCT01025336|EG004|Reported Event|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
10994787|NCT01025427|BG000|Baseline|Controller|
10994788|NCT01025427|FG000|Participant Flow|Controller|
10994789|NCT01025427|OG000|Outcome|HIV Controller|Sixteen asymptomatic controllers were prospectively treated with open-label raltegravir and tenofovir/emtricitabine for 24 weeks. Controllers were defined by the following inclusion criteria: (1) HIV-seropositive; (2) ART untreated; and (3) plasma HIV RNA <1,000 copies/mL for ≥12 months.
10994790|NCT01025427|EG000|Reported Event|Controller|
10994791|NCT01025453|BG000|Baseline|Pts Getting Temsirolimus and Sorafenib|We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 4 weeks, or at the discretion of the treating physician or patient.
10994792|NCT01025453|FG000|Participant Flow|Pts Getting Temsirolimus and Sorafenib|We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 4 weeks, or at the discretion of the treating physician or patient.
10994793|NCT01025453|OG000|Outcome|Pts Getting Temsirolimus and Sorafenib|We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 4 weeks, or at the discretion of the treating physician or patient.
10994794|NCT01025453|EG000|Reported Event|Pts Getting Temsirolimus and Sorafenib|We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 4 weeks, or at the discretion of the treating physician or patient.
10994795|NCT01025635|BG000|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
10994796|NCT01025635|BG001|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
10994797|NCT01025635|BG002|Baseline|Total|Total of all reporting groups
11348269|NCT04194151|EG000|Reported Event|2 Minute - 2 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol
11348270|NCT04194151|EG001|Reported Event|2 Minute - 1,5 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol
11348271|NCT04194151|EG002|Reported Event|2 Minute - 1 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol
10994798|NCT01025635|FG000|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
10994799|NCT01025635|FG001|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
10994800|NCT01025635|OG000|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
10994801|NCT01025635|OG001|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
10994802|NCT01025635|EG000|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
10994803|NCT01025635|EG001|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
10994804|NCT01025752|BG000|Baseline|Arm 1: IVR CBT|"Ten session IVR-based cognitive behavior therapy for chronic low back pain~IVR based cognitive behavioral therapy: Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy"
10994805|NCT01025752|BG001|Baseline|Arm 2: F2F CBT|"Ten session face to face cognitive behavior therapy for chronic low back pain~Face to face cognitive behavior therapy: Ten session face to face cognitive behavior therapy for chronic low back pain"
10994806|NCT01025752|BG002|Baseline|Total|Total of all reporting groups
10994807|NCT01025752|FG000|Participant Flow|Arm 1: IVR CBT|"Ten session IVR-based cognitive behavior therapy for chronic low back pain~IVR based cognitive behavioral therapy: Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy"
11348272|NCT04194151|EG003|Reported Event|1 Minute - 2 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol
11348273|NCT04194151|EG004|Reported Event|1 Minute - 1,5 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol
11348274|NCT04194151|EG005|Reported Event|1 Minute - 1 mg/kg Group|2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
10994808|NCT01025752|FG001|Participant Flow|Arm 2: F2F CBT|"Ten session face to face cognitive behavior therapy for chronic low back pain~Face to face cognitive behavior therapy: Ten session face to face cognitive behavior therapy for chronic low back pain"
10994809|NCT01025752|OG000|Outcome|Arm 1: IVR CBT|"Ten session IVR-based cognitive behavior therapy for chronic low back pain~IVR based cognitive behavioral therapy: Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy"
10994810|NCT01025752|OG001|Outcome|Arm 2: F2F CBT|"Ten session face to face cognitive behavior therapy for chronic low back pain~Face to face cognitive behavior therapy: Ten session face to face cognitive behavior therapy for chronic low back pain"
10994811|NCT01025752|EG000|Reported Event|Arm 1: IVR CBT|"Ten session IVR-based cognitive behavior therapy for chronic low back pain~IVR based cognitive behavioral therapy: Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy"
10994812|NCT01025752|EG001|Reported Event|Arm 2: F2F CBT|"Ten session face to face cognitive behavior therapy for chronic low back pain~Face to face cognitive behavior therapy: Ten session face to face cognitive behavior therapy for chronic low back pain"
10994813|NCT01025791|BG000|Baseline|Panel A MK-8266 (Healthy Males)|MK-8266 single dose or placebo matching MK-8266 in healthy male participants in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: 0.5 mg/ Period 4: 1.0 mg/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
10994814|NCT01025791|BG001|Baseline|Panel B MK-8266 (Healthy Males)|MK-8266 single dose or placebo matching MK-8266 in healthy male participants in Periods 1: 0.4 mg/ Period 2: 1.2 mg/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 0.4 mg fed/ Period 5: na.
11223489|NCT02354144|BG000|Baseline|Carrageenan-based Gel|"The intervention to be administered is:~a commercially available gel that contains carrageenan.~water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the placebo gel.~also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.~Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors."
11223490|NCT02354144|BG001|Baseline|Control Gel|"The intervention to be administered is:~a commercially available gel that does not contain carrageenan.~water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the carrageenan-containing gel.~also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.~Control gel: A gel not containing carrageenan"
11223491|NCT02354144|BG002|Baseline|Total|Total of all reporting groups
11223492|NCT02354144|FG000|Participant Flow|Carrageenan-based Gel|"The intervention to be administered is:~a commercially available gel that contains carrageenan.~water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the placebo gel.~also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.~Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors."
11223493|NCT02354144|FG001|Participant Flow|Control Gel|"The intervention to be administered is:~a commercially available gel that does not contain carrageenan.~water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the carrageenan-containing gel.~also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.~Control gel: A gel not containing carrageenan"
11336447|NCT03566810|FG001|Participant Flow|First Reference GXR (Fasting), Then Test GXR (Fasting)|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt, Germany) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GXR (Merck Nantong, China) on Day 8 in treatment period 2 under fasting conditions. There was a wash-out period of 7 days between each treatment period.
10994815|NCT01025791|BG002|Baseline|Panel C MK-8266 (Mild/Mod. Hypertension)|MK-8266 single dose or placebo matching MK-8266 (Mild/Mod. Hypertension) in Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: 1.2 mg dose followed in 8 hours by a 1.0 mg dose/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
10994816|NCT01025791|BG003|Baseline|Total|Total of all reporting groups
10994817|NCT01025791|FG000|Participant Flow|Panel A, Healthy Male Participants, Sequence 1|MK-8266 in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: placebo/ Period 4: 1.0 mg/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
10994818|NCT01025791|FG001|Participant Flow|Panel A, Healthy Male Participants, Sequence 2|MK-8266 in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: 0.5 mg/ Period 4: placebo/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
10994819|NCT01025791|FG002|Participant Flow|Panel A, Healthy Male Participants, Sequence 3|MK-8266 in Period 1: 0.1 mg/ Period 2: placebo/ Period 3: 0.5/ Period 4: 1.0 mg/ Period 5: placebo.
10994820|NCT01025791|FG003|Participant Flow|Panel A, Healthy Male Participants, Sequence 4|MK-8266 in Period 1: placebo/ Period 2: 0.2 mg/ Period 3: 0.5 mg/ Period 4: 1.0 mg/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
10994821|NCT01025791|FG004|Participant Flow|Panel B, Healthy Male Participants, Sequence 1|MK-8266 in Period 1: 0.4 mg/ Period 2: 1.2 mg/ Period 3: placebo/ Period 4: 0.4 mg fed/ Period 5: na.
10994822|NCT01025791|FG005|Participant Flow|Panel B, Healthy Male Participants, Sequence 2|MK-8266 in Period 1: 0.4 mg/ Period 2: placebo/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 0.4 mg fed/ Period 5: na.
10994823|NCT01025791|FG006|Participant Flow|Panel B, Healthy Male Participants, Sequence 3|MK-8266 in Period 1: 0.4 mg/ Period 2: 1.2 mg/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 0.4 mg fed/ Period 5: na.
10994824|NCT01025791|FG007|Participant Flow|Panel B, Healthy Male Participants, Sequence 4|MK-8266 in Period 1: placebo/ Period 2: 1.2 mg/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na.
10994825|NCT01025791|FG008|Participant Flow|Panel C, Mild/Moderate Hypertension, Sequence 1|Period 1: placebo/ Period 2 1.2 mg dose followed in 8 hours by a 1.0 mg dose/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
10994826|NCT01025791|FG009|Participant Flow|Panel C, Mild/Moderate Hypertension, Sequence 2|Period 1: placebo/ Period 2 1.2 mg dose followed in 8 hours by a 1.0 mg dose/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na
11224472|NCT02360293|OG000|Outcome|Stay Strong w/Coaching|"Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.~Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program."
10994827|NCT01025791|FG010|Participant Flow|Panel C, Mild/Moderate Hypertension, Sequence 3|Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2 placebo/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
10994828|NCT01025791|FG011|Participant Flow|Panel C, Mild/Moderate Hypertension, Sequence 4|Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: placebo/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na
10994829|NCT01025791|FG012|Participant Flow|Panel C, Mild/Moderate Hypertension, Sequence 5|Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: 1.2 mg dose followed in 8 hours by a 1.0 mg dose// Period 3: placebo/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
10994830|NCT01025791|FG013|Participant Flow|Panel C, Mild/Moderate Hypertension, Sequence 6|Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: 1.2 mg dose followed in 8 hours by a 1.0 mg dose// Period 3: placebo/ Period 4: placebo/ Period 5: na
10994831|NCT01025791|OG000|Outcome|Panel A MK-8266 0.1 mg (Healthy Males)|MK-8266 single 0.1 mg dose in healthy male participants
10994832|NCT01025791|OG001|Outcome|Panel A MK-8266 0.2 mg (Healthy Males)|MK-8266 single 0.2 mg dose in healthy male participants
10994833|NCT01025791|OG002|Outcome|Panel A MK-8266 0.5 mg (Healthy Males)|MK-8266 single 0.5 mg dose in healthy male participants
10994834|NCT01025791|OG003|Outcome|Panel A MK-8266 1.0 mg (Healthy Males)|MK-8266 single 1.0 mg dose in healthy male participants
10994835|NCT01025791|OG004|Outcome|Panel A MK-8266 1.0/0.8 mg (Healthy Males)|MK-8266 single 1.0 mg dose followed in 6 hours by a 0.8 mg dose in healthy male participants
10994836|NCT01025791|OG005|Outcome|Panel B MK-8266 0.4 mg (Healthy Males)|MK-8266 single dose 0.4 mg in healthy male participants
10994837|NCT01025791|OG006|Outcome|Panel B MK-8266 1.2 mg (Healthy Males)|MK- 8266 single dose 1.2 mg in healthy male participants
10994838|NCT01025791|OG007|Outcome|Panel B MK-8266 1.2/0.6 mg (Healthy Males)|MK-8266 single 1.2 mg followed in 6 hours by a 0.6 mg dose in healthy male
10994839|NCT01025791|OG008|Outcome|Panel B MK-8266 0.4 mg Fed (Healthy Males)|MK-8266 single 0.4 mg dose in healthy male participants, fed.
10994840|NCT01025791|OG009|Outcome|Panel C MK-8266 1.0/0.8 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 8 hours by a 0.8 mg dose in participants with mild/mod. hypertension
10994841|NCT01025791|OG010|Outcome|Panel C MK-8266 1.2/1.0 mg (Mild/Mod. Hypertension)|MK-8266 single 1.2 mg dose followed in 8 hours by a 1.0 mg dose in participants with mild/mod. hypertension
10994842|NCT01025791|OG011|Outcome|Panel C MK-8266 1.0/0.6/0.6 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose in participants with mild/mod. hypertension
10994843|NCT01025791|OG012|Outcome|Panel C MK-8266 1.0/1.0/0.6 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose in participants with mild/mod. hypertension
10994844|NCT01025791|OG013|Outcome|Pooled Placebo (Panels A, B, C)|Placebo matching MK-8266.
10994845|NCT01025791|OG005|Outcome|Panel A Placebo|Placebo to MK-8266
10994846|NCT01025791|OG006|Outcome|Pooled Panel B MK-8266 0.4 mg (Healthy Males)|MK- 8266 single dose 0.4 mg in healthy male participants, fasted and fed
10994847|NCT01025791|OG007|Outcome|Panel B MK-8266 1.2 mg (Healthy Males)|MK-8266 single dose 1.2 mg in healthy male participants
10994848|NCT01025791|OG008|Outcome|Panel B MK-8266 1.2/0.6 mg (Healthy Males)|MK-826 6 single 1.2 mg followed in 6 hours by a 0.6 mg dose in healthy male participants
10994849|NCT01025791|OG009|Outcome|Panel B Placebo|Placebo to MK-8266
10994850|NCT01025791|OG010|Outcome|Panel C MK-8266 1.0/0.8 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 8 hours by a 0.8 mg dose in participants with mild/mod. hypertension
10994851|NCT01025791|OG011|Outcome|Panel C MK-8266 1.2/1.0 mg (Mild/Mod. Hypertension)|MK-8266 single 1.2 mg dose followed in 8 hours by a 1.0 mg dose in participants with mild/mod. hypertension
10994852|NCT01025791|OG012|Outcome|Panel C MK-8266 1.0/0.6/0.6 mg (Mild/Mod.|MK-8266 single 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose in participants with mild/mod. hypertension
10994853|NCT01025791|OG013|Outcome|Panel C MK-8266 1.0/1.0/0.6 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose in participants with mild/mod. hypertension
10994854|NCT01025791|OG014|Outcome|Panel C Placebo|Placebo to MK-8266
10994855|NCT01025791|OG000|Outcome|Panel A MK-8266 0.1 mg (Healthy Males)|MK-826 6 single 0.1 mg dose in healthy male participants
10994856|NCT01025791|OG001|Outcome|Panel A MK-8266 0.2 mg (Healthy Males)|MK-826 6 single 0.2 mg dose in healthy male participants
10994857|NCT01025791|OG002|Outcome|Panel A MK-8266 0.5 mg (Healthy Males)|MK-826 6 single 0.5 mg dose in healthy male participants
10994858|NCT01025791|OG003|Outcome|Panel A MK-8266 1.0 mg (Healthy Males)|MK-826 6 single 1.0 mg dose in healthy male participants
10994859|NCT01025791|OG004|Outcome|Panel A MK-8266 1.0/0.8 mg (Healthy Males)|MK-826 6 single 1.0 mg dose followed in 6 hours by a 0.8 mg dose in healthy male participants
10994860|NCT01025791|OG007|Outcome|Panel B MK-8266 1.2/0.6 mg (Healthy Males)|MK-826 6 single 1.2 mg followed in 6 hours by a 0.6 mg dose in healthy male participants
10994861|NCT01025791|OG009|Outcome|Panel C MK- 8266 1.0/0.8 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 8 hours by a 0.8 mg dose in participants with mild/mod. hypertension
10994862|NCT01025791|OG010|Outcome|Panel C MK- 8266 1.2/1.0 mg (Mild/Mod. Hypertension)|MK-8266 single 1.2 mg dose followed in 8 hours by a 1.0 mg dose in participants with mild/mod. hypertension
10994863|NCT01025791|OG012|Outcome|Panel C MK- 8266 1.0/1.0/0.6 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose in participants with mild/mod. hypertension
10994864|NCT01025791|OG000|Outcome|Panel B MK-8266 0.4 mg (Healthy Males)|MK-8266 single dose 0.4 mg in healthy male participants
10994865|NCT01025791|OG001|Outcome|Panel B MK-8266 0.4 mg Fed (Healthy Males)|MK-8266 single 0.4 mg dose in healthy male participants, fed.
10994866|NCT01025791|EG000|Reported Event|Panel A MK-8266 0.1 mg (Healthy Males)|MK-8266 single 0.1 mg dose in healthy male participants
10994867|NCT01025791|EG001|Reported Event|Panel A MK-8266 0.2 mg (Healthy Males)|MK-8266 single 0.2 mg dose in healthy male participants
10994868|NCT01025791|EG002|Reported Event|Panel A MK-8266 0.5 mg (Healthy Males)|MK-8266 single 0.5 mg dose in healthy male participants
10994869|NCT01025791|EG003|Reported Event|Panel A MK-8266 1.0 mg (Healthy Males)|MK-8266 single 1.0 mg dose in healthy male participants
10994870|NCT01025791|EG004|Reported Event|Panel A MK-8266 1.0/0.8 mg (Healthy Males)|MK-8266 single 1.0 mg dose followed in 6 hours by a 0.8 mg dose in healthy male participants
10994871|NCT01025791|EG005|Reported Event|Panel B MK-8266 0.4 mg (Healthy Males)|MK-8266 single dose 0.4 mg in healthy male participants
10994872|NCT01025791|EG006|Reported Event|Panel B MK-8266 1.2 mg (Healthy Males)|MK- 8266 single dose 1.2 mg in healthy male participants
10994873|NCT01025791|EG007|Reported Event|Panel B MK-8266 1.2/0.6 mg (Healthy Males)|MK-8266 single 1.2 mg followed in 6 hours by a 0.6 mg dose in healthy male participants
10994874|NCT01025791|EG008|Reported Event|Panel B MK-8266 0.4 mg Fed (Healthy Males)|MK-8266 single 0.4 mg dose in healthy male participants, fed.
10994875|NCT01025791|EG009|Reported Event|Panel C MK-8266 1.0/0.8 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 8 hours by a 0.8 mg dose in participants with mild/mod. hypertension
10994876|NCT01025791|EG010|Reported Event|Panel C MK-8266 1.2/1.0 mg (Mild/Mod. Hypertension)|MK-8266 single 1.2 mg dose followed in 8 hours by a 1.0 mg dose in participants with mild/mod. hypertension
10994877|NCT01025791|EG011|Reported Event|Panel C MK-8266 1.0/0.6/0.6 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose in participants with mild/mod. hypertension
10994878|NCT01025791|EG012|Reported Event|Panel C MK-8266 1.0/1.0/0.6 mg (Mild/Mod. Hypertension)|MK-8266 single 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose in participants with mild/mod. hypertension
10994879|NCT01025791|EG013|Reported Event|Pooled Placebo (Panels A, B, C)|Placebo matching MK-8266.
10994880|NCT01025817|BG000|Baseline|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
10994881|NCT01025817|BG001|Baseline|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
10994882|NCT01025817|BG002|Baseline|Total|Total of all reporting groups
11007549|NCT01091428|BG004|Baseline|Total|Total of all reporting groups
10994883|NCT01025817|FG000|Participant Flow|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
10994884|NCT01025817|FG001|Participant Flow|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
10994885|NCT01025817|OG000|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
10994886|NCT01025817|OG001|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
10994887|NCT01025817|EG000|Reported Event|Everolimus and Low Dose Tacrolimus|Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
10994888|NCT01025817|EG001|Reported Event|Mycophenolate Mofetil and Standard Dose Tacrolimus|The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
10994889|NCT01025830|BG000|Baseline|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
10994890|NCT01025830|FG000|Participant Flow|Generic (Triomune) to Brand (Zerit/Epivir/Viramune)|Started with generic formulation (Triomune) then switched to brand formulation (Zerit/Epivir/Viramune).
10994891|NCT01025830|FG001|Participant Flow|Brand (Zerit/Epivir/Viramune) to Generic (Triomune)|started with brand formulation(Zerit/Epivir/Viramune) then switched to generic formulation (Triomune)
10994892|NCT01025830|OG000|Outcome|Generic Stavudine|period when subjects were on generic stavudine
10994893|NCT01025830|OG001|Outcome|Brand Stavudine|period when subjects were on brand stavudine
10994894|NCT01025830|OG002|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
10994895|NCT01025830|OG003|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
10994896|NCT01025830|OG004|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
10994897|NCT01025830|OG005|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
10994898|NCT01025830|EG000|Reported Event|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
10994899|NCT01025830|EG001|Reported Event|Generic to Brand|Started with generic formulation then switched to brand formulation
10994900|NCT01025830|EG002|Reported Event|Brand to Generic|started with brand formulation then switched to generic formulation
10994901|NCT01025843|BG000|Baseline|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
10994902|NCT01025843|BG001|Baseline|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
10994903|NCT01025843|BG002|Baseline|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994904|NCT01025843|BG003|Baseline|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
10994905|NCT01025843|BG004|Baseline|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
10994906|NCT01025843|BG005|Baseline|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994907|NCT01025843|BG006|Baseline|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994908|NCT01025843|BG007|Baseline|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
10994909|NCT01025843|BG008|Baseline|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994910|NCT01025843|BG009|Baseline|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
10994911|NCT01025843|BG010|Baseline|Total|Total of all reporting groups
10994912|NCT01025843|FG000|Participant Flow|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994913|NCT01025843|FG001|Participant Flow|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
10994914|NCT01025843|FG002|Participant Flow|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994915|NCT01025843|FG003|Participant Flow|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
10994916|NCT01025843|FG004|Participant Flow|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
10994917|NCT01025843|FG005|Participant Flow|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994918|NCT01025843|FG006|Participant Flow|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994919|NCT01025843|FG007|Participant Flow|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
10994920|NCT01025843|FG008|Participant Flow|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
10994921|NCT01025843|FG009|Participant Flow|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
10994922|NCT01025843|OG000|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
10994923|NCT01025843|OG001|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
10994924|NCT01025843|OG002|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
10994925|NCT01025843|OG003|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
10994926|NCT01025843|OG004|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
10994927|NCT01025843|OG005|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
10994928|NCT01025843|OG006|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
10994929|NCT01025843|OG007|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
10994930|NCT01025843|OG008|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
10994931|NCT01025843|OG009|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
10994932|NCT01025843|OG010|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
10994933|NCT01025843|OG011|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
10994934|NCT01025843|OG012|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
10994935|NCT01025843|EG000|Reported Event|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
10994936|NCT01025843|EG001|Reported Event|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
10994937|NCT01025843|EG002|Reported Event|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
10994938|NCT01025843|EG003|Reported Event|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
11223494|NCT02354144|OG000|Outcome|Carrageenan-based Gel|"The intervention to be administered is:~a commercially available gel that contains carrageenan.~water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the placebo gel.~also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.~Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors."
11223495|NCT02354144|OG001|Outcome|Control Gel|"The intervention to be administered is:~a commercially available gel that does not contain carrageenan.~water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the carrageenan-containing gel.~also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.~Control gel: A gel not containing carrageenan"
11223496|NCT02354144|EG000|Reported Event|Carrageenan-based Gel|"The intervention to be administered is:~a commercially available gel that contains carrageenan.~water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the placebo gel.~also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.~Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors."
11223497|NCT02354144|EG001|Reported Event|Control Gel|"The intervention to be administered is:~a commercially available gel that does not contain carrageenan.~water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the carrageenan-containing gel.~also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.~Control gel: A gel not containing carrageenan"
11223498|NCT02354222|BG000|Baseline|Teneligliptin+Canagliflozin|Teneligliptin for 24 weeks in combination with Canagliflozin
11223499|NCT02354222|BG001|Baseline|Placebo+Canagliflozin|Placebo for 24 weeks in combination with Canagliflozin
11223500|NCT02354222|BG002|Baseline|Total|Total of all reporting groups
11223501|NCT02354222|FG000|Participant Flow|Teneligliptin+Canagliflozin|Teneligliptin for 24 weeks in combination with Canagliflozin
11223502|NCT02354222|FG001|Participant Flow|Placebo+Canagliflozin|Placebo for 24 weeks in combination with Canagliflozin
11223503|NCT02354222|OG000|Outcome|Teneligliptin+Canagliflozin|Teneligliptin for 24 weeks in combination with Canagliflozin
11223504|NCT02354222|OG001|Outcome|Placebo+Canagliflozin|Placebo for 24 weeks in combination with Canagliflozin
10994939|NCT01025843|EG004|Reported Event|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
10994940|NCT01025843|EG005|Reported Event|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
10994941|NCT01025843|EG006|Reported Event|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
10994942|NCT01025843|EG007|Reported Event|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
10994943|NCT01025843|EG008|Reported Event|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
10994944|NCT01025843|EG009|Reported Event|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
10994945|NCT01025843|EG010|Reported Event|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
10994946|NCT01025843|EG011|Reported Event|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
10994947|NCT01025843|EG012|Reported Event|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
10994948|NCT01026012|BG000|Baseline|Combined Stress Group|patient's were monitor for approximately 30 minutes following regadenoson infusion
10994949|NCT01026012|FG000|Participant Flow|Combined Stress Group|Subjects had a sub-maximal symptom limited stress test (<85% MPHR)then immediately followed by pharmological stress test with the infusion of regadenoson 400mcg infused over 10-20 seconds.
10994950|NCT01026012|OG000|Outcome|Combined Stress Group|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.
10994951|NCT01026012|EG000|Reported Event|Safety|patient's were monitor for approximately 30 minutes following regadenoson infusion
10994952|NCT01026038|BG000|Baseline|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
10994953|NCT01026038|BG001|Baseline|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
10994954|NCT01026038|BG002|Baseline|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
10994955|NCT01026038|BG003|Baseline|Total|Total of all reporting groups
10994956|NCT01026038|FG000|Participant Flow|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
10994957|NCT01026038|FG001|Participant Flow|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
10994958|NCT01026038|FG002|Participant Flow|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
10994959|NCT01026038|OG000|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
10994960|NCT01026038|OG001|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
10994961|NCT01026038|OG002|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
10994962|NCT01026038|EG000|Reported Event|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
10994963|NCT01026038|EG001|Reported Event|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
10994964|NCT01026038|EG002|Reported Event|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
10994965|NCT01026103|BG000|Baseline|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
10994966|NCT01026103|FG000|Participant Flow|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
10994967|NCT01026103|OG000|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
10994968|NCT01026103|EG000|Reported Event|Tri Staple|This is a single arm study.
10994969|NCT01026142|BG000|Baseline|A: Capecitabine + Trastuzumab|Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
10994970|NCT01026142|BG001|Baseline|B: Capecitabine + Trastuzumab + Pertuzumab|Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
10994971|NCT01026142|BG002|Baseline|Total|Total of all reporting groups
10994972|NCT01026142|FG000|Participant Flow|A: Capecitabine + Trastuzumab|Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
10994973|NCT01026142|FG001|Participant Flow|B: Capecitabine + Trastuzumab + Pertuzumab|Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
10994974|NCT01026142|OG000|Outcome|A: Capecitabine + Trastuzumab|Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
10994975|NCT01026142|OG001|Outcome|B: Capecitabine + Trastuzumab + Pertuzumab|Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
10994976|NCT01026142|EG000|Reported Event|A: Capecitabine + Trastuzumab|Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
10994977|NCT01026142|EG001|Reported Event|B: Capecitabine + Trastuzumab + Pertuzumab|Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
10994978|NCT01026181|BG000|Baseline|LSG (Lap SG)|Laparoscopic Sleeve Gastrectomy
10994979|NCT01026181|BG001|Baseline|LRYGB|Laparoscopic Roux-en-Y Gastric Bypass
10994980|NCT01026181|BG002|Baseline|LAGB|Laparoscopic Adjustable Gastric Banding
10994981|NCT01026181|BG003|Baseline|Total|Total of all reporting groups
10994982|NCT01026181|FG000|Participant Flow|Laparoscopic Sleeve Gastrectomy|Patient who had Laparoscopic Sleeve Gastrectomy for their morbid obesity
10994983|NCT01026181|FG001|Participant Flow|Laparoscopic Roux-en-Y Gastric Bypass|Patients who had Laparoscopic Roux-en-Y Gastric Bypass for their morbid obesity
11223505|NCT02354222|EG000|Reported Event|Teneligliptin+Canagliflozin|Teneligliptin for 24 weeks in combination with Canagliflozin
11223506|NCT02354222|EG001|Reported Event|Placebo+Canagliflozin|Placebo for 24 weeks in combination with Canagliflozin
11223507|NCT02354235|BG000|Baseline|Canagliflozin+Teneligliptin|Canagliflozin for 24 weeks in combination with Teneligliptin
10877078|NCT00445315|OG002|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877079|NCT00445315|OG004|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
10877080|NCT00445315|EG000|Reported Event|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877081|NCT00445315|EG001|Reported Event|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877082|NCT00445315|EG002|Reported Event|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
10877083|NCT00445315|EG003|Reported Event|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
10877084|NCT00445315|EG004|Reported Event|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
10877085|NCT00445328|BG000|Baseline|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
10877086|NCT00445328|BG001|Baseline|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
10877087|NCT00445328|BG002|Baseline|Total|Total of all reporting groups
10877088|NCT00445328|FG000|Participant Flow|Dalteparin|5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
11223508|NCT02354235|BG001|Baseline|Placebo+Teneligliptin|Placebo for 24 weeks in combination with Teneligliptin
10877089|NCT00445328|FG001|Participant Flow|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
10877090|NCT00445328|OG000|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
10877091|NCT00445328|OG001|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
10877092|NCT00445328|EG000|Reported Event|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
10877093|NCT00445328|EG001|Reported Event|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
10877094|NCT00445341|BG000|Baseline|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
10877095|NCT00445341|FG000|Participant Flow|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
10877096|NCT00445341|OG000|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
10877097|NCT00445341|EG000|Reported Event|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
10877098|NCT00445432|BG000|Baseline|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
10877099|NCT00445432|BG001|Baseline|Placebo Eow|Double-blind adalimumab placebo every other week
10877100|NCT00445432|BG002|Baseline|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
10877101|NCT00445432|BG003|Baseline|Total|Total of all reporting groups
10877102|NCT00445432|FG000|Participant Flow|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
10877103|NCT00445432|FG001|Participant Flow|Placebo Eow|Double-blind adalimumab placebo every other week
10877104|NCT00445432|FG002|Participant Flow|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
10877105|NCT00445432|FG003|Participant Flow|Any Adalimumab|All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
10877106|NCT00445432|OG000|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
10877107|NCT00445432|OG001|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
10877108|NCT00445432|OG002|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
10877109|NCT00445432|OG000|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
10877110|NCT00445432|OG000|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
10877111|NCT00445432|EG000|Reported Event|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
10877112|NCT00445432|EG001|Reported Event|Placebo Eow|Double-blind adalimumab placebo every other week
10877113|NCT00445432|EG002|Reported Event|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
11223509|NCT02354235|BG002|Baseline|Total|Total of all reporting groups
11223510|NCT02354235|FG000|Participant Flow|Canagliflozin+Teneligliptin|Canagliflozin for 24 weeks in combination with Teneligliptin
11223511|NCT02354235|FG001|Participant Flow|Placebo+Teneligliptin|Placebo for 24 weeks in combination with Teneligliptin
11223512|NCT02354235|OG000|Outcome|Canagliflozin+Teneligliptin|Canagliflozin for 24 weeks in combination with Teneligliptin
11223513|NCT02354235|OG001|Outcome|Placebo+Teneligliptin|Placebo for 24 weeks in combination with Teneligliptin
11223514|NCT02354235|EG000|Reported Event|Canagliflozin+Teneligliptin|Canagliflozin for 24 weeks in combination with Teneligliptin
10994984|NCT01026181|FG002|Participant Flow|Laparoscopic Adjustable Gastric Banding|Patients who had Laparoscopic Adjustable Gastric Banding for their morbid obesity
10994985|NCT01026181|OG000|Outcome|Laparoscopic Sleeve Gastrectomy|
10994986|NCT01026181|OG001|Outcome|Laparoscopic Roux-en-Y Gastric Bypass|
10994987|NCT01026181|OG002|Outcome|Laparoscopic Adjustable Gastric Banding|
10994988|NCT01026181|EG000|Reported Event|Laparoscopic Sleeve Gastrectomy|
10994989|NCT01026181|EG001|Reported Event|Laparoscopic Roux-en-Y Gastric Bypass|
10994990|NCT01026181|EG002|Reported Event|Laparoscopic Adjustable Gastric Banding|
10994991|NCT01026194|BG000|Baseline|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
10994992|NCT01026194|BG001|Baseline|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
10994993|NCT01026194|BG002|Baseline|Total|Total of all reporting groups
10994994|NCT01026194|FG000|Participant Flow|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
10994995|NCT01026194|FG001|Participant Flow|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
10994996|NCT01026194|OG000|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
10994997|NCT01026194|OG001|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
10994998|NCT01026194|EG000|Reported Event|Placebo/Teneli + Pio (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
10994999|NCT01026194|EG001|Reported Event|Teneli/Teneli + Pio (Data Through Week 12)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
10995000|NCT01026194|EG002|Reported Event|Placebo/Teneli + Pio (Data From Week 12 to Week 52)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
10995001|NCT01026194|EG003|Reported Event|Teneli/Teneli + Pio (Data Through Week 52)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
10995002|NCT01026324|BG000|Baseline|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
10995003|NCT01026324|BG001|Baseline|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
10995004|NCT01026324|BG002|Baseline|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
10995005|NCT01026324|BG003|Baseline|Total|Total of all reporting groups
10995006|NCT01026324|FG000|Participant Flow|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10995007|NCT01026324|FG001|Participant Flow|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10995008|NCT01026324|FG002|Participant Flow|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3(30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10995009|NCT01026324|OG000|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
10995010|NCT01026324|OG000|Outcome|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
10995011|NCT01026324|OG001|Outcome|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
10995012|NCT01026324|OG002|Outcome|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
10995013|NCT01026324|EG000|Reported Event|Dose Level 1 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 10 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
11223515|NCT02354235|EG001|Reported Event|Placebo+Teneligliptin|Placebo for 24 weeks in combination with Teneligliptin
10995014|NCT01026324|EG001|Reported Event|Dose Level 2 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 20 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
10995015|NCT01026324|EG002|Reported Event|Dose Level 3 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 30 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
10995016|NCT01026389|BG000|Baseline|Gadovist|Patient received contrast-enhanced MRA with Gadovist
10995017|NCT01026389|BG001|Baseline|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
10995018|NCT01026389|BG002|Baseline|Total|Total of all reporting groups
10995019|NCT01026389|FG000|Participant Flow|Gadovist|Patient received contrast-enhanced MRA with Gadovist
10995020|NCT01026389|FG001|Participant Flow|Dotarem|Patients received contrast-enhanced MRA with Dotarem
10995021|NCT01026389|OG000|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
10995022|NCT01026389|OG001|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
10995023|NCT01026389|EG000|Reported Event|Gadovist|Patient received contrast-enhanced MRA with Gadovist
11223516|NCT02354339|BG000|Baseline|Irvingia Gabonensis|"Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks~Irvingia gabonensis: Intervention will be administered 30 minutes before meals"
11223517|NCT02354339|BG001|Baseline|Placebo|"Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks~Placebo: Intervention will be administered 30 minutes before meals"
11223518|NCT02354339|BG002|Baseline|Total|Total of all reporting groups
10995024|NCT01026389|EG001|Reported Event|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
10995025|NCT01026402|BG000|Baseline|Part A 25mg BD Soln Cont|Continuous BD dosing
10995026|NCT01026402|BG001|Baseline|Part A 50mg BD Soln Cont|Continuous BD dosing
10995027|NCT01026402|BG002|Baseline|Part B 50mg BD Soln Cont|Continuous BD dosing
10995028|NCT01026402|BG003|Baseline|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
10995029|NCT01026402|BG004|Baseline|Part A 75mg QD Soln Cont|Continuous QD dosing
10995030|NCT01026402|BG005|Baseline|Part A 125mg QD Soln Cont|Continuous QD dosing
10995031|NCT01026402|BG006|Baseline|Part A 100mg QD Tab Cont|Continuous QD dosing
10995032|NCT01026402|BG007|Baseline|Part A 125mg QD Tab Cont|Continuous QD dosing
10995033|NCT01026402|BG008|Baseline|Part A 175mg QD Tab Cont|Continuous QD dosing
10995034|NCT01026402|BG009|Baseline|Part A 100mg BD Tab Int|Intermittent BD dosing
10995035|NCT01026402|BG010|Baseline|Part A 125mg BD Tab Int|Intermittent BD dosing
10995036|NCT01026402|BG011|Baseline|Part A 170mg BD Tab Int|Intermittent BD dosing
11223519|NCT02354339|FG000|Participant Flow|Irvingia Gabonensis|"Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks~Irvingia gabonensis: Intervention will be administered 30 minutes before meals"
11223520|NCT02354339|FG001|Participant Flow|Placebo|"Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks~Placebo: Intervention will be administered 30 minutes before meals"
11223521|NCT02354339|OG000|Outcome|Irvingia Gabonensis|"Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks~Irvingia gabonensis: Intervention will be administered 30 minutes before meals"
10995037|NCT01026402|BG012|Baseline|Part A 225mg BD Tab Int|Intermittent BD dosing
10995038|NCT01026402|BG013|Baseline|Part B 125mg BD Tab Int|Intermittent BD dosing
10995039|NCT01026402|BG014|Baseline|Part B 170mg BD Tab Int|Intermittent BD dosing
10995040|NCT01026402|BG015|Baseline|Part A 70mg BD Soln Cont|Continuous BD dosing
10995041|NCT01026402|BG016|Baseline|Part A 100mg BD Soln Cont|Continuous BD dosing
10995042|NCT01026402|BG017|Baseline|Total|Total of all reporting groups
10995043|NCT01026402|FG000|Participant Flow|Part A 25mg BD Soln Cont|Continuous BD dosing
10995044|NCT01026402|FG001|Participant Flow|Part A 50mg BD Soln Cont|Continuous BD dosing
10995045|NCT01026402|FG002|Participant Flow|Part B 50mg BD Soln Cont|Continuous BD dosing
10995046|NCT01026402|FG003|Participant Flow|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
10995047|NCT01026402|FG004|Participant Flow|Part A 75mg QD Soln Cont|Continuous QD dosing
10995048|NCT01026402|FG005|Participant Flow|Part A 125mg QD Soln Cont|Continuous QD dosing
10995049|NCT01026402|FG006|Participant Flow|Part A 100mg QD Tab Cont|Continuous QD dosing
10995050|NCT01026402|FG007|Participant Flow|Part A 125mg QD Tab Cont|Continuous QD dosing
10995051|NCT01026402|FG008|Participant Flow|Part A 175mg QD Tab Cont|Continuous QD dosing
10995052|NCT01026402|FG009|Participant Flow|Part A 100mg BD Tab Int|Intermittent BD dosing
10995053|NCT01026402|FG010|Participant Flow|Part A 125mg BD Tab Int|Intermittent BD dosing
10995054|NCT01026402|FG011|Participant Flow|Part A 170mg BD Tab Int|Intermittent BD dosing
10995055|NCT01026402|FG012|Participant Flow|Part A 225mg BD Tab Int|Intermittent BD dosing
10995056|NCT01026402|FG013|Participant Flow|Part B 125mg BD Tab Int|Intermittent BD dosing
10995057|NCT01026402|FG014|Participant Flow|Part B 170mg BD Tab Int|Intermittent BD dosing
10995058|NCT01026402|FG015|Participant Flow|Part A 70mg BD Soln Cont|Continuous BD dosing
10995059|NCT01026402|FG016|Participant Flow|Part A 100mg BD Soln Cont|Continuous BD dosing
10995060|NCT01026402|OG000|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
10995061|NCT01026402|OG001|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
10995062|NCT01026402|OG002|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
10995063|NCT01026402|OG003|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
10995064|NCT01026402|OG004|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
11223522|NCT02354339|OG001|Outcome|Placebo|"Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks~Placebo: Intervention will be administered 30 minutes before meals"
10995065|NCT01026402|OG005|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
10995066|NCT01026402|OG006|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
10995067|NCT01026402|OG007|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
10995068|NCT01026402|OG008|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
10995069|NCT01026402|OG009|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
10995070|NCT01026402|OG010|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
10995071|NCT01026402|OG011|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
10995072|NCT01026402|OG012|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
10995073|NCT01026402|OG013|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
10995074|NCT01026402|OG014|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
10995075|NCT01026402|OG015|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
10995076|NCT01026402|OG016|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
10995077|NCT01026402|OG017|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
10995078|NCT01026402|OG018|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
10995079|NCT01026402|EG000|Reported Event|Part A - AZD2014 100 mg BD Solution|Continuous BD dosing
10995080|NCT01026402|EG001|Reported Event|Part A - AZD2014 100 mg QD Tablet|Continuous QD dosing
10995081|NCT01026402|EG002|Reported Event|Part A - AZD2014 125 mg QD Solution|Continous QD dosing
10995082|NCT01026402|EG003|Reported Event|Part A - AZD2014 125 mg QD Tablet|Continuous QD dosing
10995083|NCT01026402|EG004|Reported Event|Part A - AZD2014 175 mg QD Tablet|Continuous QD dosing
10995084|NCT01026402|EG005|Reported Event|Part A - AZD2014 25 mg BD Solution|Continuous BD dosing
10995085|NCT01026402|EG006|Reported Event|Part A - AZD2014 50 mg BD Solution|Continuous BD dosing
10995086|NCT01026402|EG007|Reported Event|Part A - AZD2014 70 mg BD Solution|Continuous BD dosing
10995087|NCT01026402|EG008|Reported Event|Part A - AZD2014 75 mg QD Solution|Continuous QD dosing
10995088|NCT01026402|EG009|Reported Event|Part A - Intermittent AZD2014 100 mg BD Tablet|Intermittent BD dosing
10995089|NCT01026402|EG010|Reported Event|Part A - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
10995090|NCT01026402|EG011|Reported Event|Part A - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
10995091|NCT01026402|EG012|Reported Event|Part A - Intermittent AZD2014 225 mg BD Tablet|Intermittent BD dosing
10995092|NCT01026402|EG013|Reported Event|Part B - AZD2014 50 mg BD Solution|Continuous BD dosing
10995093|NCT01026402|EG014|Reported Event|Part B - AZD2014 50 mg BD Tablet Fasted/Fed|Continuous BD dosing
10995094|NCT01026402|EG015|Reported Event|Part B - AZD2014 BD 50 mg Tablet Fed/Fasted|Continuous BD dosing
10995095|NCT01026402|EG016|Reported Event|Part B - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
10995096|NCT01026402|EG017|Reported Event|Part B - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
10995097|NCT01026454|BG000|Baseline|Acyclovir Then Valacyclovir|acyclovir 400 mg orally twice daily for 12 weeks, 2 week washout, then valacyclovir 1.5 g orally twice daily for 12 weeks
10995098|NCT01026454|BG001|Baseline|Valacyclovir Then Acyclovir|valacyclovir 1.5 g orally twice daily for 12 weeks, 2 week washout, then acyclovir 400 mg orally twice daily for 12 weeks
10995099|NCT01026454|BG002|Baseline|Total|Total of all reporting groups
10995100|NCT01026454|FG000|Participant Flow|Acyclovir Then Valacyclovir|Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks)
10995101|NCT01026454|FG001|Participant Flow|Valacyclovir Then Acyclovir|Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)
10995102|NCT01026454|OG000|Outcome|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
10995103|NCT01026454|OG001|Outcome|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
10995104|NCT01026454|EG000|Reported Event|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
10995105|NCT01026454|EG001|Reported Event|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
10995106|NCT01026493|BG000|Baseline|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
10995107|NCT01026493|BG001|Baseline|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
10995108|NCT01026493|BG002|Baseline|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
10995109|NCT01026493|BG003|Baseline|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
10995110|NCT01026493|BG004|Baseline|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
10995111|NCT01026493|BG005|Baseline|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
10995112|NCT01026493|BG006|Baseline|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
10995113|NCT01026493|BG007|Baseline|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
10995114|NCT01026493|BG008|Baseline|Total|Total of all reporting groups
10995115|NCT01026493|FG000|Participant Flow|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
10995116|NCT01026493|FG001|Participant Flow|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
10995117|NCT01026493|FG002|Participant Flow|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
10995118|NCT01026493|FG003|Participant Flow|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
10995119|NCT01026493|FG004|Participant Flow|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
10995120|NCT01026493|FG005|Participant Flow|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
10995121|NCT01026493|FG006|Participant Flow|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
10995122|NCT01026493|FG007|Participant Flow|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
10995123|NCT01026493|OG000|Outcome|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
10995124|NCT01026493|OG001|Outcome|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
10995125|NCT01026493|OG002|Outcome|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
10995126|NCT01026493|OG003|Outcome|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
10995127|NCT01026493|OG000|Outcome|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
10995128|NCT01026493|OG001|Outcome|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
10995129|NCT01026493|OG002|Outcome|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
10995130|NCT01026493|OG003|Outcome|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
10995131|NCT01026493|EG000|Reported Event|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
10995132|NCT01026493|EG001|Reported Event|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
10995133|NCT01026493|EG002|Reported Event|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
10995134|NCT01026493|EG003|Reported Event|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
10995135|NCT01026493|EG004|Reported Event|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
11223523|NCT02354339|EG000|Reported Event|Irvingia Gabonensis|"Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks~Irvingia gabonensis: Intervention will be administered 30 minutes before meals"
11223524|NCT02354339|EG001|Reported Event|Placebo|"Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks~Placebo: Intervention will be administered 30 minutes before meals"
10995136|NCT01026493|EG005|Reported Event|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
10995137|NCT01026493|EG006|Reported Event|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
10995138|NCT01026493|EG007|Reported Event|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
10995139|NCT01026623|BG000|Baseline|IMC-A12: 6mg/kg Temsirolimus 20 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)"
10995140|NCT01026623|BG001|Baseline|IMC-A12: 6 mg/kg Temsirolimus 25 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly"
10995141|NCT01026623|BG002|Baseline|IMC-A12: 20 mg/kg Temsirolimus 20 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study"
10995142|NCT01026623|BG003|Baseline|Total|Total of all reporting groups
10995143|NCT01026623|FG000|Participant Flow|IMC-A12: 6 mg/kg & Temsirolimus (CCI-779): 20 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)"
10995144|NCT01026623|FG001|Participant Flow|IMC-A12: 6 mg/kg & Temsirolimus (CCI-779): 25 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly"
10995145|NCT01026623|FG002|Participant Flow|IMC-A12: 20 mg/kg & Temsirolimus (CCI-779): 20 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study"
10995146|NCT01026623|OG000|Outcome|IMC-A12: 6 mg/kg Temsirolimus 20 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)"
10995147|NCT01026623|OG001|Outcome|IMC-A12: 6 mg/kg Temsirolimus 25 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly"
11007550|NCT01091428|FG000|Participant Flow|Alisertib (Phase 1 - Ovarian Cancer)|Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).
10877114|NCT00445432|EG003|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
10877115|NCT00445458|BG000|Baseline|Neratinib 160 mg + Paclitaxel 80 mg/m2|Neratinib 160 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle.
10877116|NCT00445458|BG001|Baseline|Neratinib 240 mg + Paclitaxel 80 mg/m2|Neratinib 240 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle.
10877117|NCT00445458|BG002|Baseline|Arm A Neratinib (MTD) + Paclitaxel|Neratinib (MTD) + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease
10877118|NCT00445458|BG003|Baseline|Arm B Neratinib (MTD) + Paclitaxel|Neratinib (MTD) + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease
10877119|NCT00445458|BG004|Baseline|Total|Total of all reporting groups
10877120|NCT00445458|FG000|Participant Flow|Neratinib 160 mg + Paclitaxel 80 mg/m2|Neratinib 160 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle.
10877121|NCT00445458|FG001|Participant Flow|Neratinib 240 mg + Paclitaxel 80 mg/m2|Neratinib 240 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle.
10877122|NCT00445458|FG002|Participant Flow|Arm A Neratinib (MTD) + Paclitaxel 80 mg/m2|Neratinib (MTD) qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
10877123|NCT00445458|FG003|Participant Flow|Arm B Neratinib (MTD) + Paclitaxel 80 mg/m2|Neratinib (MTD) + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
10877124|NCT00445458|OG000|Outcome|Neratinib 160 mg + Paclitaxel 80 mg/m²|Neratinib 160 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
10877125|NCT00445458|OG001|Outcome|Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
10877126|NCT00445458|OG000|Outcome|Part 1. Neratinib + Paclitaxel 80 mg/m²|Daily Administration of Neratinib in combination with Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle.
10877127|NCT00445458|OG000|Outcome|Arm A Neratinib (MTD) + Paclitaxel|Neratinib (MTD) + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
10877128|NCT00445458|OG001|Outcome|Arm B Neratinib (MTD) + Paclitaxel|Neratinib (MTD) + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimens for metastatic disease.
10877129|NCT00445458|OG000|Outcome|Neratinib 160 mg + Paclitaxel 80 mg/m²|Neratinib 160 mg, once a day, orally, in combination with paclitaxel 80 mg/m², IV, given on days 1, 8, and 15 of a 28 day cycle.
10877130|NCT00445458|OG001|Outcome|Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg, once a day, orally, in combination with paclitaxel 80 mg/m², IV, given on days 1, 8, and 15 of a 28 day cycle.
10877131|NCT00445458|EG000|Reported Event|Neratinib 160 mg + Paclitaxel 80 mg/m2|Neratinib 160 mg qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle.
10877132|NCT00445458|EG001|Reported Event|Neratinib 240 mg+ Paclitaxel 80 mg/m2|Neratinib 240 mg qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle.
10877133|NCT00445458|EG002|Reported Event|Arm A Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2|Neratinib (MTD) qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease
10877134|NCT00445458|EG003|Reported Event|Arm B Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2|Neratinib (MTD) qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease
10877135|NCT00445484|BG000|Baseline|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
10877136|NCT00445484|BG001|Baseline|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
10877137|NCT00445484|BG002|Baseline|Total|Total of all reporting groups
10877138|NCT00445484|FG000|Participant Flow|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
10877139|NCT00445484|FG001|Participant Flow|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
10877140|NCT00445484|OG000|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
10877141|NCT00445484|OG001|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
10995148|NCT01026623|OG002|Outcome|IMC-A12: 20 mg/kg Temsirolimus 20 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study"
10995149|NCT01026623|OG002|Outcome|Arm 1A|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study"
10995150|NCT01026623|EG000|Reported Event|IMC-A12: 6mg/kg Temsirolimus 20 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)"
10995151|NCT01026623|EG001|Reported Event|IMC-A12: 6 mg/kg Temsirolimus 25 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly"
10995152|NCT01026623|EG002|Reported Event|IMC-A12: 20 mg/kg Temsirolimus 20 mg|"Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study"
10995153|NCT01026792|BG000|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10995154|NCT01026792|FG000|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10995155|NCT01026792|OG000|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10995156|NCT01026792|EG000|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10995157|NCT01026805|BG000|Baseline|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
10995158|NCT01026805|FG000|Participant Flow|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
10995159|NCT01026805|OG000|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
10995160|NCT01026805|EG000|Reported Event|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
10995161|NCT01026818|BG000|Baseline|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995162|NCT01026818|BG001|Baseline|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995163|NCT01026818|BG002|Baseline|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995164|NCT01026818|BG003|Baseline|Total|Total of all reporting groups
11223525|NCT02354352|BG000|Baseline|Eplerenone|"Eplerenone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Inspra. Eplerenone is a potassium-sparing diuretic.~Eplerenone: 26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months."
10995165|NCT01026818|FG000|Participant Flow|Screen - BNSRP|BNSRP surgery during Screening Period.
10995166|NCT01026818|FG001|Participant Flow|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995167|NCT01026818|FG002|Participant Flow|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995168|NCT01026818|FG003|Participant Flow|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995169|NCT01026818|OG000|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995170|NCT01026818|OG001|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995171|NCT01026818|OG002|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995172|NCT01026818|EG000|Reported Event|Screen - BNSRP|Had bilateral nerve-sparing radical prostatectomy (BNSRP) surgery during Screening Period.
10995173|NCT01026818|EG001|Reported Event|Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
10995174|NCT01026818|EG002|Reported Event|Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
10995175|NCT01026818|EG003|Reported Event|Placebo (Double-Blind Period/Washout Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
10995176|NCT01026818|EG004|Reported Event|Tadalafil 5 mg OaD (Open-Label Period)|Tadalafil 5 mg OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995177|NCT01026818|EG005|Reported Event|Tadalfil 20 mg PRN (Open-Label Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995178|NCT01026818|EG006|Reported Event|Placebo (Open-Label Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
10995179|NCT01026831|BG000|Baseline|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
10995180|NCT01026831|BG001|Baseline|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
10995181|NCT01026831|BG002|Baseline|Total|Total of all reporting groups
10995182|NCT01026831|FG000|Participant Flow|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
10995183|NCT01026831|FG001|Participant Flow|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
10995184|NCT01026831|OG000|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
10995185|NCT01026831|OG001|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
10995186|NCT01026831|EG000|Reported Event|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
10995187|NCT01026831|EG001|Reported Event|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
10995188|NCT01026844|BG000|Baseline|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
10995189|NCT01026844|BG001|Baseline|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
11223526|NCT02354352|BG001|Baseline|Spironolactone|"Spironolactone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Aldactone. Spironolactone is a potassium-sparing diuretic.~Spironolactone: 26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months."
10995190|NCT01026844|BG002|Baseline|Total|Total of all reporting groups
11223527|NCT02354352|BG002|Baseline|Total|Total of all reporting groups
10995191|NCT01026844|FG000|Participant Flow|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
10995192|NCT01026844|FG001|Participant Flow|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
10995193|NCT01026844|OG000|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
10995194|NCT01026844|OG001|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
10995195|NCT01026844|EG000|Reported Event|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
10995196|NCT01026844|EG001|Reported Event|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
10995197|NCT01026909|BG000|Baseline|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
10995198|NCT01026909|BG001|Baseline|Control|observation
10995199|NCT01026909|BG002|Baseline|Total|Total of all reporting groups
10995200|NCT01026909|FG000|Participant Flow|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
10995201|NCT01026909|FG001|Participant Flow|Control|Observation
10995202|NCT01026909|OG000|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
10995203|NCT01026909|OG001|Outcome|Control|Observation
10995204|NCT01026909|EG000|Reported Event|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
10995205|NCT01026909|EG001|Reported Event|Control|Observation
10995206|NCT01026948|BG000|Baseline|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
10995207|NCT01026948|FG000|Participant Flow|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
10995208|NCT01026948|OG000|Outcome|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
10995209|NCT01026948|OG000|Outcome|Acceptability|Maternal views were assessed using semi-structured diaries
10995210|NCT01026948|EG000|Reported Event|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
10995211|NCT01026974|BG000|Baseline|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
10995212|NCT01026974|BG001|Baseline|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
10995213|NCT01026974|BG002|Baseline|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995214|NCT01026974|BG003|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
10995215|NCT01026974|BG004|Baseline|Total|Total of all reporting groups
10995216|NCT01026974|FG000|Participant Flow|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
10995217|NCT01026974|FG001|Participant Flow|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
10995218|NCT01026974|FG002|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995219|NCT01026974|FG003|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
10995220|NCT01026974|OG000|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
10995221|NCT01026974|OG001|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
10995222|NCT01026974|OG002|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995223|NCT01026974|OG000|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
10995224|NCT01026974|OG001|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
10995225|NCT01026974|OG002|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
11223528|NCT02354352|FG000|Participant Flow|Eplerenone|"Eplerenone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Inspra. Eplerenone is a potassium-sparing diuretic.~Eplerenone: 26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months."
10877142|NCT00445484|EG000|Reported Event|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
10877143|NCT00445484|EG001|Reported Event|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
10877144|NCT00445549|BG000|Baseline|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
10877145|NCT00445549|FG000|Participant Flow|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
10877146|NCT00445549|OG000|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
10877147|NCT00445549|EG000|Reported Event|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
10877148|NCT00445588|BG000|Baseline|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
10877149|NCT00445588|FG000|Participant Flow|Treatment|"Patients receive oral erlotinib hydrochloride 150 mg once daily and oral sorafenib tosylate 400 mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride 150mg: Given orally once daily~sorafenib tosylate 400mg: Given orally twice daily~pharmacological study: Correlative studies"
10877150|NCT00445588|OG000|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride 150mg: Given orally once daily~sorafenib tosylate 400mg: Given orally twice daily~pharmacological study: Correlative studies"
10877151|NCT00445588|OG000|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
10877152|NCT00445588|EG000|Reported Event|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
10877153|NCT00445601|BG000|Baseline|Arm I|"Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.~gemcitabine hydrochloride: Given intravesically"
10877154|NCT00445601|BG001|Baseline|Arm II|"Patients receive intravesical placebo over 1 hour post-TURBT.~placebo: Given intravesically"
10877155|NCT00445601|BG002|Baseline|Total|Total of all reporting groups
10877156|NCT00445601|FG000|Participant Flow|Arm I|"Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.~gemcitabine hydrochloride: Given intravesically"
10877157|NCT00445601|FG001|Participant Flow|Arm II|"Patients receive intravesical placebo over 1 hour post-TURBT.~placebo: Given intravesically"
10877158|NCT00445601|OG000|Outcome|Arm I|"Patients receive intravesical gemcitabine hydrochloride over 1 hour.~gemcitabine hydrochloride: Given intravesically"
10877159|NCT00445601|OG001|Outcome|Arm II|"Patients receive intravesical placebo over 1 hour.~placebo: Given intravesically"
10877160|NCT00445601|OG000|Outcome|Arm I|"Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.~gemcitabine hydrochloride: Given intravesically"
10877161|NCT00445601|OG001|Outcome|Arm II|"Patients receive intravesical placebo over 1 hour post-TURBT.~placebo: Given intravesically"
10877162|NCT00445601|OG000|Outcome|Arm I: Gemcitabine|Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.
10877163|NCT00445601|OG001|Outcome|Arm II: Placebo|Patients receive intravesical placebo over 1 hour post -TURBT.
10877164|NCT00445601|EG000|Reported Event|Arm I: Gemcitabine|Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.
10877165|NCT00445601|EG001|Reported Event|Arm II: Placebo|Patients receive intravesical placebo over 1 hour post-TURBT.
10877166|NCT00445679|BG000|Baseline|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
10877167|NCT00445679|BG001|Baseline|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
10877168|NCT00445679|BG002|Baseline|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
10877169|NCT00445679|BG003|Baseline|Paroxetine 20|Paroxetine 20 mg/day
10877170|NCT00445679|BG004|Baseline|Total|Total of all reporting groups
10877171|NCT00445679|FG000|Participant Flow|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
10877172|NCT00445679|FG001|Participant Flow|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
10877173|NCT00445679|FG002|Participant Flow|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
10877174|NCT00445679|FG003|Participant Flow|Paroxetine 20|Paroxetine 20 mg/day
10877175|NCT00445679|OG000|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
10877176|NCT00445679|OG001|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
10877177|NCT00445679|OG002|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
10995226|NCT01026974|OG002|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
11223529|NCT02354352|FG001|Participant Flow|Spironolactone|"Spironolactone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Aldactone. Spironolactone is a potassium-sparing diuretic.~Spironolactone: 26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months."
10877178|NCT00445679|OG003|Outcome|Paroxetine 20|Paroxetine 20 mg/day
10877179|NCT00445679|EG000|Reported Event|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
10877180|NCT00445679|EG001|Reported Event|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
10877181|NCT00445679|EG002|Reported Event|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
10877182|NCT00445679|EG003|Reported Event|Paroxetine 20|Paroxetine 20 mg/day
10877183|NCT00445692|BG000|Baseline|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given Orally (PO)~Dexamethasone: Given PO~Lenalidomide: Given PO"
10877184|NCT00445692|FG000|Participant Flow|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin orally twice daily and dexamethasone orally once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide orally once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given Orally (PO)~Dexamethasone: Given PO~Lenalidomide: Given PO"
10877185|NCT00445692|OG000|Outcome|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin orally (PO) twice a day and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given PO~Dexamethasone: Given PO~Lenalidomide: Given PO"
10877186|NCT00445692|OG000|Outcome|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given PO~Dexamethasone: Given PO~Lenalidomide: Given PO"
10877187|NCT00445692|OG000|Outcome|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given Orally (PO)~Dexamethasone: Given PO~Lenalidomide: Given PO"
10877188|NCT00445692|EG000|Reported Event|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given Orally (PO)~Dexamethasone: Given PO~Lenalidomide: Given PO"
10877189|NCT00445705|BG000|Baseline|Placebo|Part A: Placebo every 12 hours for 4 weeks
10877190|NCT00445705|BG001|Baseline|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
10877191|NCT00445705|BG002|Baseline|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
10877192|NCT00445705|BG003|Baseline|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
10877193|NCT00445705|BG004|Baseline|Total|Total of all reporting groups
10877194|NCT00445705|FG000|Participant Flow|Placebo|Part A: Placebo every 12 hours for 4 weeks
10877195|NCT00445705|FG001|Participant Flow|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
10877196|NCT00445705|FG002|Participant Flow|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
10877197|NCT00445705|FG003|Participant Flow|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
10877198|NCT00445705|OG000|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
10877199|NCT00445705|OG001|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
10877200|NCT00445705|OG002|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
10877201|NCT00445705|OG003|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
10877202|NCT00445705|EG000|Reported Event|Placebo|Part A: Placebo every 12 hours for 4 weeks
10877203|NCT00445705|EG001|Reported Event|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
10877204|NCT00445705|EG002|Reported Event|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
10877205|NCT00445705|EG003|Reported Event|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
10995227|NCT01026974|OG000|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995228|NCT01026974|OG001|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
10995229|NCT01026974|EG000|Reported Event|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
10995230|NCT01026974|EG001|Reported Event|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
10995231|NCT01026974|EG002|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995232|NCT01026974|EG003|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
10995233|NCT01027000|BG000|Baseline|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
10995234|NCT01027000|FG000|Participant Flow|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
10995235|NCT01027000|OG000|Outcome|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
10995236|NCT01027000|EG000|Reported Event|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
10995237|NCT01027195|BG000|Baseline|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
10995238|NCT01027195|BG001|Baseline|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
10995239|NCT01027195|BG002|Baseline|Total|Total of all reporting groups
10995240|NCT01027195|FG000|Participant Flow|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
10995241|NCT01027195|FG001|Participant Flow|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
11007551|NCT01091428|FG001|Participant Flow|Alisertib (Phase 1 - Breast Cancer)|Participants with breast cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).
11223530|NCT02354352|OG000|Outcome|Eplerenone|"Eplerenone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Inspra. Eplerenone is a potassium-sparing diuretic.~Eplerenone: 26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months."
11223531|NCT02354352|OG001|Outcome|Spironolactone|"Spironolactone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Aldactone. Spironolactone is a potassium-sparing diuretic.~Spironolactone: 26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months."
11223532|NCT02354352|EG000|Reported Event|Eplerenone|"Eplerenone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Inspra. Eplerenone is a potassium-sparing diuretic.~Eplerenone: 26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months."
11223533|NCT02354352|EG001|Reported Event|Spironolactone|"Spironolactone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Aldactone. Spironolactone is a potassium-sparing diuretic.~Spironolactone: 26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months."
10995242|NCT01027195|OG000|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
10995243|NCT01027195|OG001|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
10995244|NCT01027195|EG000|Reported Event|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
10995245|NCT01027195|EG001|Reported Event|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
10995246|NCT01027273|BG000|Baseline|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
10995247|NCT01027273|BG001|Baseline|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
11223534|NCT02354378|BG000|Baseline|Children Undergoing Sedation With Dexmedetomidine|"Children who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of dexmedetomidine.~Dexmedetomidine~Memory Test"
11223535|NCT02354378|BG001|Baseline|Children Not Undergoing Sedation|"A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing.~Memory Test"
11223536|NCT02354378|BG002|Baseline|Total|Total of all reporting groups
11223537|NCT02354378|FG000|Participant Flow|Children Undergoing Sedation With Dexmedetomidine|"Children who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of dexmedetomidine.~Dexmedetomidine~Memory Test"
11223538|NCT02354378|FG001|Participant Flow|Children Not Undergoing Sedation|"A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing.~Memory Test"
11223539|NCT02354378|OG000|Outcome|Children Undergoing Sedation With Dexmedetomidine|"Children who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of dexmedetomidine.~Dexmedetomidine~Memory Test"
11223540|NCT02354378|OG001|Outcome|Children Not Undergoing Sedation|"A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing.~Memory Test"
10995248|NCT01027273|BG002|Baseline|Total|Total of all reporting groups
11007552|NCT01091428|FG002|Participant Flow|Alisertib 40 mg BID+ Paclitaxel 60 mg/m^2 (Phase 2)|Alisertib 40 mg, orally, BID on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2 (Up to 28 cycles).
11223541|NCT02354378|EG000|Reported Event|Children Undergoing Sedation With Dexmedetomidine|"Children who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of dexmedetomidine.~Dexmedetomidine~Memory Test"
10995249|NCT01027273|FG000|Participant Flow|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
10995250|NCT01027273|FG001|Participant Flow|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
10995251|NCT01027273|OG000|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
10995252|NCT01027273|OG001|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
10995253|NCT01027273|EG000|Reported Event|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
10995254|NCT01027273|EG001|Reported Event|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
10995255|NCT01027286|BG000|Baseline|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
10995256|NCT01027286|BG001|Baseline|Control|No Vitagel used during primary total knee arthroplasty
10995257|NCT01027286|BG002|Baseline|Total|Total of all reporting groups
10995258|NCT01027286|FG000|Participant Flow|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
10995259|NCT01027286|FG001|Participant Flow|Control|No Vitagel used during primary total knee arthroplasty
10995260|NCT01027286|OG000|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
10995261|NCT01027286|OG001|Outcome|Control|No Vitagel used during primary total knee arthroplasty
10995262|NCT01027286|EG000|Reported Event|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
10995263|NCT01027286|EG001|Reported Event|Control|No Vitagel used during primary total knee arthroplasty
10995264|NCT01027351|BG000|Baseline|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
10995265|NCT01027351|BG001|Baseline|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
10995266|NCT01027351|BG002|Baseline|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
10995267|NCT01027351|BG003|Baseline|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
10995268|NCT01027351|BG004|Baseline|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995269|NCT01027351|BG005|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
10995270|NCT01027351|BG006|Baseline|Total|Total of all reporting groups
10995271|NCT01027351|FG000|Participant Flow|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
10995272|NCT01027351|FG001|Participant Flow|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
10995273|NCT01027351|FG002|Participant Flow|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
10995274|NCT01027351|FG003|Participant Flow|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
10995275|NCT01027351|FG004|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995276|NCT01027351|FG005|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
10995277|NCT01027351|OG000|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
10995278|NCT01027351|OG001|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
10995279|NCT01027351|OG002|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995280|NCT01027351|OG002|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
10995281|NCT01027351|OG003|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
10995282|NCT01027351|OG000|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
10995283|NCT01027351|OG001|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
10995284|NCT01027351|OG000|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
10995285|NCT01027351|OG001|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
10995286|NCT01027351|OG000|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995287|NCT01027351|OG001|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
10995288|NCT01027351|OG004|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995289|NCT01027351|OG005|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
10995290|NCT01027351|EG000|Reported Event|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
10995291|NCT01027351|EG001|Reported Event|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
10995292|NCT01027351|EG002|Reported Event|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
10995293|NCT01027351|EG003|Reported Event|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
10995294|NCT01027351|EG004|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
10995295|NCT01027351|EG005|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
10995296|NCT01027364|BG000|Baseline|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
10995297|NCT01027364|BG001|Baseline|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
10995298|NCT01027364|BG002|Baseline|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
10995299|NCT01027364|BG003|Baseline|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
10995300|NCT01027364|BG004|Baseline|Total|Total of all reporting groups
10995301|NCT01027364|FG000|Participant Flow|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
10995302|NCT01027364|FG001|Participant Flow|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
10995303|NCT01027364|FG002|Participant Flow|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
10995304|NCT01027364|FG003|Participant Flow|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
10995305|NCT01027364|OG000|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
10995306|NCT01027364|OG001|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
10995307|NCT01027364|OG002|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
10995308|NCT01027364|OG000|Outcome|Arm 1: Weekly Prophylaxis-BeneFIX|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
10995309|NCT01027364|OG001|Outcome|Arm 1: Weekly Prophylaxis-rFIXFc|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
10995310|NCT01027364|OG002|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
10995311|NCT01027364|OG003|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
10995312|NCT01027364|OG004|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
10995313|NCT01027364|OG000|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
10995314|NCT01027364|OG000|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
10995315|NCT01027364|OG000|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
10995316|NCT01027364|OG001|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
10995317|NCT01027364|OG000|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
10995318|NCT01027364|OG001|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
10995319|NCT01027364|OG003|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
10995320|NCT01027364|OG004|Outcome|Total|All participants from Arms 1-4
10995321|NCT01027364|OG000|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
10995322|NCT01027364|OG000|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
10995323|NCT01027364|OG001|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
10995324|NCT01027364|OG002|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
10995325|NCT01027364|OG003|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
10995326|NCT01027364|EG000|Reported Event|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
10995327|NCT01027364|EG001|Reported Event|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
10995328|NCT01027364|EG002|Reported Event|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
10995329|NCT01027416|BG000|Baseline|No Intervention|No Intervention: Standard of care
10995330|NCT01027416|BG001|Baseline|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
10995331|NCT01027416|BG002|Baseline|Total|Total of all reporting groups
10995332|NCT01027416|FG000|Participant Flow|No Intervention|No Intervention: Standard of care
10995333|NCT01027416|FG001|Participant Flow|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
10995334|NCT01027416|OG000|Outcome|No Intervention|No Intervention: Standard of care
10995335|NCT01027416|OG001|Outcome|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
10995336|NCT01027416|EG000|Reported Event|No Intervention|No Intervention: Standard of care
10995337|NCT01027416|EG001|Reported Event|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
10995338|NCT01027468|BG000|Baseline|Group 1|3 year follow-up of intravitreal application of bevacizumab
10995339|NCT01027468|FG000|Participant Flow|Group 1|3 year follow-up of patients with intravitreal application of bevacizumab: From August 2005 to July 2006: 1 mg (0.04 mL) of bevacizumab After July 2006: 2.5 mg (0.1 mL) of Bevacizumab Follow-up intervals: 6-8 weeks
10995340|NCT01027468|OG000|Outcome|Group 1|3 year follow-up of intravitreal application of bevacizumab
10995341|NCT01027468|EG000|Reported Event|Group 1|3 year follow-up of intravitreal application of bevacizumab
10995342|NCT01027559|BG000|Baseline|Depressed Group: CBT|"Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.~Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84."
10995343|NCT01027559|BG001|Baseline|Depressed Group: SRT|"Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.~Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response."
10995344|NCT01027559|BG002|Baseline|Healthy Control Group|Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
10995345|NCT01027559|BG003|Baseline|Total|Total of all reporting groups
10995346|NCT01027559|FG000|Participant Flow|Depressed Group: CBT|"Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.~Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84."
10995347|NCT01027559|FG001|Participant Flow|Healthy Control Group|Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
10995348|NCT01027559|FG002|Participant Flow|Depressed Group: Sertraline|"Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.~Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response."
11007553|NCT01091428|FG003|Participant Flow|Paclitaxel 80 mg/m^2 (Phase 2)|Paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2 (Up to 28 cycles).
11007554|NCT01091428|OG000|Outcome|Alisertib + Paclitaxel (Phase 1)|Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).
11007555|NCT01091428|OG000|Outcome|Alisertib + Paclitaxel|Paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1.
10995349|NCT01027559|OG000|Outcome|Depressed Group|"Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.~Cognitive Behavioral Therapy: Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed."
10995350|NCT01027559|OG001|Outcome|Healthy Control Group|Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
10995351|NCT01027559|OG000|Outcome|Depressed Group: CBT|"Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.~Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84."
10995352|NCT01027559|OG002|Outcome|Depressed Group: Sertraline|"Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.~Sertraline: Visits will involve dispensing medication, side effects assessment and Hamilton Depression Rating Scale (HAMD) administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response."
10995353|NCT01027559|EG000|Reported Event|Depressed Group: CBT|"Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.~Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84."
10995354|NCT01027559|EG001|Reported Event|Healthy Control Group|Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
10995355|NCT01027559|EG002|Reported Event|Depressed Group: SSRI (Selective Serotonin Re-Uptake Inhibitor|"Depressed participants randomized to receive setraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.~Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response."
10995356|NCT01027598|BG000|Baseline|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
10995357|NCT01027598|BG001|Baseline|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
10995358|NCT01027598|BG002|Baseline|Total|Total of all reporting groups
10995359|NCT01027598|FG000|Participant Flow|Erlotinib + Pazopanib|"Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
10995360|NCT01027598|FG001|Participant Flow|Erlotinib + Placebo|"Erlotinib: 150 mg orally daily~Placebo: orally daily"
10995361|NCT01027598|OG000|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
10995362|NCT01027598|OG001|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
10995363|NCT01027598|EG000|Reported Event|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
10995364|NCT01027598|EG001|Reported Event|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
10995365|NCT01027650|BG000|Baseline|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
10995366|NCT01027650|BG001|Baseline|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
10995367|NCT01027650|BG002|Baseline|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
10995368|NCT01027650|BG003|Baseline|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
10995369|NCT01027650|BG004|Baseline|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
10995370|NCT01027650|BG005|Baseline|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
10995371|NCT01027650|BG006|Baseline|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
10995372|NCT01027650|BG007|Baseline|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
10995373|NCT01027650|BG008|Baseline|Total|Total of all reporting groups
10995374|NCT01027650|FG000|Participant Flow|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
10995375|NCT01027650|FG001|Participant Flow|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
10995376|NCT01027650|FG002|Participant Flow|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
10995377|NCT01027650|FG003|Participant Flow|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
10995378|NCT01027650|FG004|Participant Flow|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
10995379|NCT01027650|FG005|Participant Flow|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
10995380|NCT01027650|FG006|Participant Flow|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
10995381|NCT01027650|FG007|Participant Flow|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
10995382|NCT01027650|OG000|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
10995383|NCT01027650|OG001|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
10995384|NCT01027650|OG002|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
10995385|NCT01027650|OG003|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
10995386|NCT01027650|OG000|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
10995387|NCT01027650|OG001|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
10995388|NCT01027650|OG002|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
10995389|NCT01027650|OG003|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
10995390|NCT01027650|EG000|Reported Event|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
10995391|NCT01027650|EG001|Reported Event|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
10995392|NCT01027650|EG002|Reported Event|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
10995393|NCT01027650|EG003|Reported Event|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
10995394|NCT01027650|EG004|Reported Event|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
10995395|NCT01027650|EG005|Reported Event|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
10995396|NCT01027650|EG006|Reported Event|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
10995397|NCT01027650|EG007|Reported Event|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
10995398|NCT01027754|BG000|Baseline|Varenicline|"Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12~Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day"
10995399|NCT01027754|BG001|Baseline|Placebo|"Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12~Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily"
10995400|NCT01027754|BG002|Baseline|Total|Total of all reporting groups
10995401|NCT01027754|FG000|Participant Flow|Varenicline|"Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12~Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day"
10995402|NCT01027754|FG001|Participant Flow|Placebo|"Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12~Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily"
10995403|NCT01027754|OG000|Outcome|Varenicline|"Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12~Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day"
10995404|NCT01027754|OG001|Outcome|Placebo|"Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12~Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily"
10995405|NCT01027754|EG000|Reported Event|Varenicline|"Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12~Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day"
10995406|NCT01027754|EG001|Reported Event|Placebo|"Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12~Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily"
10995407|NCT01027780|BG000|Baseline|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
10995408|NCT01027780|BG001|Baseline|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
10995409|NCT01027780|BG002|Baseline|Total|Total of all reporting groups
10995410|NCT01027780|FG000|Participant Flow|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
10995411|NCT01027780|FG001|Participant Flow|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
10995412|NCT01027780|OG000|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
10995413|NCT01027780|OG001|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
10995414|NCT01027780|OG000|Outcome|Mindfulness Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
10995415|NCT01027780|EG000|Reported Event|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
10995416|NCT01027780|EG001|Reported Event|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
10995417|NCT01027793|BG000|Baseline|Tretinoin|"Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.~Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks."
10995418|NCT01027793|BG001|Baseline|Superficial Dermabrasion|"Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.~Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center"
10995419|NCT01027793|BG002|Baseline|Total|Total of all reporting groups
11007556|NCT01091428|OG000|Outcome|Alisertib (Phase 1 - Ovarian Cancer)|Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).
10995420|NCT01027793|FG000|Participant Flow|Tretinoin|"Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.~Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks."
10995421|NCT01027793|FG001|Participant Flow|Superficial Dermabrasion|"Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.~Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center"
10995422|NCT01027793|OG000|Outcome|Tretinoin|"Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.~Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks."
10995423|NCT01027793|OG001|Outcome|Superficial Dermabrasion|"Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.~Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center"
10995424|NCT01027793|EG000|Reported Event|Tretinoin|"Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.~Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks."
10995425|NCT01027793|EG001|Reported Event|Superficial Dermabrasion|"Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.~Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center"
10995426|NCT01027806|BG000|Baseline|Montelukast|Montelukast: 1 pill per day for 16 weeks
10995427|NCT01027806|BG001|Baseline|Placebo|Placebo: 1 pill per day for 16 weeks
10995428|NCT01027806|BG002|Baseline|Total|Total of all reporting groups
10995429|NCT01027806|FG000|Participant Flow|Montelukast|Montelukast: 1 pill per day for 16 weeks
10995430|NCT01027806|FG001|Participant Flow|Placebo|Placebo: 1 pill per day for 16 weeks
10995431|NCT01027806|OG000|Outcome|Montelukast|Montelukast: 1 pill per day for 16 weeks
10995432|NCT01027806|OG001|Outcome|Placebo|Placebo: 1 pill per day for 16 weeks
10995433|NCT01027806|EG000|Reported Event|Montelukast|Montelukast: 1 pill per day for 16 weeks
10995434|NCT01027806|EG001|Reported Event|Placebo|Placebo: 1 pill per day for 16 weeks
10995435|NCT01027819|BG000|Baseline|Mobile Bearing|Mobile bearing vs Fixed bearing
10995436|NCT01027819|BG001|Baseline|Fixed Bearing|Mobile bearing vs Fixed bearing
10995437|NCT01027819|BG002|Baseline|Total|Total of all reporting groups
10995438|NCT01027819|FG000|Participant Flow|Mobile Bearing|Mobile bearing vs Fixed bearing
10995439|NCT01027819|FG001|Participant Flow|Fixed Bearing|Mobile bearing vs Fixed bearing
10995440|NCT01027819|OG000|Outcome|Mobile Bearing|Mobile bearing vs Fixed bearing
10995441|NCT01027819|OG001|Outcome|Fixed Bearing|Mobile bearing vs Fixed bearing
10995442|NCT01027819|EG000|Reported Event|Mobile Bearing|Mobile bearing vs Fixed bearing
10995443|NCT01027819|EG001|Reported Event|Fixed Bearing|Mobile bearing vs Fixed bearing
10995444|NCT01027845|BG000|Baseline|10Pn Group|"Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT KAKETSUKEN Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase)."
10995445|NCT01027845|BG001|Baseline|DTPa Group|"Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis.."
10995446|NCT01027845|BG002|Baseline|Total|Total of all reporting groups
10995447|NCT01027845|FG000|Participant Flow|10Pn Group|"Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT KAKETSUKEN Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase)."
11007557|NCT01091428|OG001|Outcome|Alisertib (Phase 1 - Breast Cancer)|Participants with breast cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).
11007558|NCT01091428|OG000|Outcome|Alisertib 40 mg BID+ Paclitaxel 60 mg/m^2 (Phase 2)|Alisertib 40 mg, orally, BID on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2 (Up to 28 cycles).
11007559|NCT01091428|OG001|Outcome|Paclitaxel 80 mg/m^2 (Phase 2)|Paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2.
10995448|NCT01027845|FG001|Participant Flow|DTPa Group|"Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis.."
10995449|NCT01027845|FG002|Participant Flow|DTPa + Prevenar Group|"Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample and considered optional treatment as standard of care."
10995450|NCT01027845|FG003|Participant Flow|DTPa - no Prevenar Group|"Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample."
10995451|NCT01027845|OG000|Outcome|10Pn Group|"Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT KAKETSUKEN Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase)."
10995452|NCT01027845|OG001|Outcome|DTPa Group|"Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis.."
10995453|NCT01027845|OG001|Outcome|DTPa + Prevenar Group|"Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample and considered optional treatment as standard of care."
10995454|NCT01027845|OG002|Outcome|DTPa - no Prevenar Group|"Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample."
10995455|NCT01027845|OG001|Outcome|DTPa Booster Group|Subjects from DTPa + Prevenar Group and DTPa - no Prevenar Group.
10995456|NCT01027845|EG000|Reported Event|10Pn Group|"Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT KAKETSUKEN Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase)."
10995457|NCT01027845|EG001|Reported Event|DTPa Group|"Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT KAKETSUKEN Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis.."
10995458|NCT01027871|BG000|Baseline|Insulin Glargine|Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
10995459|NCT01027871|BG001|Baseline|LY2605541 Algorithm 1|Participants took both LY2605541 and their pre-study insulin for first several days
10995460|NCT01027871|BG002|Baseline|LY2605541 Algrithm 2|Participants took only LY2605541 with first dose doubled
10995461|NCT01027871|BG003|Baseline|Total|Total of all reporting groups
10995462|NCT01027871|FG000|Participant Flow|Insulin Glargine|Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
10995463|NCT01027871|FG001|Participant Flow|LY2605541 Algorithm 1|Participants took both LY2605541 and their pre-study insulin for first several days
10995464|NCT01027871|FG002|Participant Flow|LY2605541 Algorithm 2|Participants took only LY2605541 with first dose doubled
10995465|NCT01027871|OG000|Outcome|Insulin Glargine|Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
10995466|NCT01027871|OG001|Outcome|LY2605541 Algorithm 1|"Participants took both LY2605541 and their pre-study insulin for first several days~Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks"
10995467|NCT01027871|OG002|Outcome|LY2605541 Algorithm 2|"Participants took only LY2605541 with first dose doubled~Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks"
10995468|NCT01027871|OG001|Outcome|LY2605541 Combined|"LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2~Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days~Algorithm 2: Participants took only LY2605541 with first dose doubled~Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks"
10995469|NCT01027871|OG001|Outcome|LY2605541 Combined|Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
10995470|NCT01027871|OG001|Outcome|LY2605541 Combined|"Participants took both LY2605541 and their pre-study insulin for first several days~Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks"
10995471|NCT01027871|OG002|Outcome|LY2605541 Algorithm 2|Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
10995472|NCT01027871|OG000|Outcome|LY2605541 Combined|"LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2~Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days~Algorithm 2: Participants took only LY2605541 with first dose doubled~Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks"
10995473|NCT01027871|EG000|Reported Event|LY2605541 Dosing Algorithm 1|subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
10995474|NCT01027871|EG001|Reported Event|LY2605541 Dosing Algorithm 2|subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
10995475|NCT01027871|EG002|Reported Event|Insulin Glargine|Subcutaneous injection of insulin Glargine every morning with dose titration based on blood glucose measures for 12 weeks
10995476|NCT01027884|BG000|Baseline|Placebo|Two matching placebo tablets were taken three times a day with meals
10995477|NCT01027884|BG001|Baseline|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
10995478|NCT01027884|BG002|Baseline|Total|Total of all reporting groups
10995479|NCT01027884|FG000|Participant Flow|Placebo|Two matching placebo tablets were taken three times a day with meals
10995480|NCT01027884|FG001|Participant Flow|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
11348275|NCT04194008|BG000|Baseline|Nerivio Device Treatment|"Treatment with active Nerivio device~Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
10995481|NCT01027884|OG000|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
10995482|NCT01027884|OG001|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
10995483|NCT01027884|OG000|Outcome|Placebo|"Placebo 900 mg/day~Placebo: Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
10995484|NCT01027884|OG001|Outcome|Idebenone|"Idebenone 900 mg/day~Idebenone: Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
10995485|NCT01027884|EG000|Reported Event|Placebo|Two matching placebo tablets were taken three times a day with meals
10995486|NCT01027884|EG001|Reported Event|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
10995487|NCT01027897|BG000|Baseline|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
10995488|NCT01027897|FG000|Participant Flow|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
10995489|NCT01027897|OG000|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
10995490|NCT01027897|EG000|Reported Event|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
10995491|NCT01027910|BG000|Baseline|PCI-24781 + Doxorubicin Without Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, without (Arm A) mandatory G-CSF support was established.
10995492|NCT01027910|BG001|Baseline|PCI-24781 + Doxorubicin With Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, with (Arm B) mandatory G-CSF support was established.
10995493|NCT01027910|BG002|Baseline|Total|Total of all reporting groups
10995494|NCT01027910|FG000|Participant Flow|PCI-24781 + Doxorubicin Without Mandatory GCSF|"PCI-24781 + Doxorubicin without mandatory GCSF~PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle~Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
10995495|NCT01027910|FG001|Participant Flow|PCI-24781 + Doxorubicin With Mandatory GCSF|"PCI-24781 + Doxorubicin with mandatory GCSF~PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle~Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
10995496|NCT01027910|OG000|Outcome|PCI-24781 + Doxorubicin Without Mandatory GCSF|
10995497|NCT01027910|OG001|Outcome|PCI-24781 With Mandatory GCSF|
10995498|NCT01027910|OG000|Outcome|Optional GCSF|
10995499|NCT01027910|OG001|Outcome|Mandatory GCSF|
10995500|NCT01027910|EG000|Reported Event|PCI-24781+Dox Without Mandated GCSF|Patients in this arm were not mandated treatment with GCSF
10995501|NCT01027910|EG001|Reported Event|PCI-24781+Dox With Mandated GCSF|Patients in this are were mandated treatment with GCSF
10995502|NCT01027949|BG000|Baseline|Oral Treprostinil|Subjects eligible for TDE-PH-304 previously participated in Studies TDE PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, or TDE PH-308.
10995503|NCT01027949|FG000|Participant Flow|Oral Treprostinil|Subjects eligible for TDE-PH-304 previously participated in Studies TDE-PH-202 (NCT01104870), TDE-PH-203 (NCT01477333), and TDE-PH-205 (NCT01588405), TDE-PH-301 (NCT00325442), TDE-PH-302 (NCT00325403), or TDE PH-308 (NCT00887978)
10995504|NCT01027949|OG000|Outcome|Oral Treprostinil|Subjects eligible for TDE-PH-304 previously participated in Studies TDE PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, or TDE PH-308.
10995505|NCT01027949|EG000|Reported Event|Oral Treprostinil|Subjects eligible for TDE-PH-304 previously participated in Studies TDE PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, or TDE PH-308.
10995506|NCT01028014|BG000|Baseline|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 daily for 14 days
10995507|NCT01028014|BG001|Baseline|Solifenacin 5mg Daily|5 mg capsule, 1 daily for 14 days
10995508|NCT01028014|BG002|Baseline|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
10995509|NCT01028014|BG003|Baseline|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
10995510|NCT01028014|BG004|Baseline|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
10995511|NCT01028014|BG005|Baseline|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
10995512|NCT01028014|BG006|Baseline|Total|Total of all reporting groups
10995513|NCT01028014|FG000|Participant Flow|Pseudoephedrine 120mg ER Daily|120 mg extended release tablet one daily for 14 days
10995514|NCT01028014|FG001|Participant Flow|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
10995515|NCT01028014|FG002|Participant Flow|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
10995516|NCT01028014|FG003|Participant Flow|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
10995517|NCT01028014|FG004|Participant Flow|Cyclobenzaprine 10mg Daily|10 mg tablet, one daily for 14 days
10995518|NCT01028014|FG005|Participant Flow|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
10995519|NCT01028014|OG000|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
10995520|NCT01028014|OG001|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
10995521|NCT01028014|OG002|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
10995522|NCT01028014|OG003|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
10995523|NCT01028014|OG004|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
10995524|NCT01028014|OG005|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
10995525|NCT01028014|EG000|Reported Event|Pseudoephedrine 120mg ER Daily|120mg extended release, one daily for 14 days
10995526|NCT01028014|EG001|Reported Event|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
10995527|NCT01028014|EG002|Reported Event|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
10995528|NCT01028014|EG003|Reported Event|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
10995529|NCT01028014|EG004|Reported Event|Cyclobenzaprine 10mg Daily|10mg tablet, one daily for 14 days
10995530|NCT01028014|EG005|Reported Event|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
10995531|NCT01028027|BG000|Baseline|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
10995532|NCT01028027|BG001|Baseline|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
10995533|NCT01028027|BG002|Baseline|Total|Total of all reporting groups
10995534|NCT01028027|FG000|Participant Flow|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
10995535|NCT01028027|FG001|Participant Flow|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
10995536|NCT01028027|OG000|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
10995537|NCT01028027|OG001|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
10995538|NCT01028027|EG000|Reported Event|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
10995539|NCT01028027|EG001|Reported Event|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
10995540|NCT01028053|BG000|Baseline|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
10995541|NCT01028053|FG000|Participant Flow|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
10995542|NCT01028053|OG000|Outcome|Hazard Ratio|"The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.~As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases."
10995543|NCT01028053|OG000|Outcome|Not Clinically Probable Alzheimer's Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to not clinically probable Alzheimer's Disease (pAD).
10995544|NCT01028053|OG001|Outcome|Clinically Probable Alzheimer's Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to clinically probable Alzheimer's Disease (pAD).
10995545|NCT01028053|EG000|Reported Event|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an intravenous dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
10995546|NCT01028131|BG000|Baseline|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
10995547|NCT01028131|BG001|Baseline|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
10995548|NCT01028131|BG002|Baseline|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples - cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
10995549|NCT01028131|BG003|Baseline|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
10995550|NCT01028131|BG004|Baseline|Total|Total of all reporting groups
10995551|NCT01028131|FG000|Participant Flow|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
10995552|NCT01028131|FG001|Participant Flow|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
10995553|NCT01028131|FG002|Participant Flow|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples(looking for clean samples with cotinine less than 100 ng/ml) at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
10995554|NCT01028131|FG003|Participant Flow|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
10995555|NCT01028131|OG000|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
10995556|NCT01028131|OG001|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
10995557|NCT01028131|OG002|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
10995558|NCT01028131|OG003|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
10995559|NCT01028131|EG000|Reported Event|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
10995560|NCT01028131|EG001|Reported Event|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
11007560|NCT01091428|OG000|Outcome|Alisertib 10 mg BID + Paclitaxel 80 mg/m^2|Alisertib (MLN8237) 10 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1.
11007561|NCT01091428|OG001|Outcome|Alisertib 20 mg BID + Paclitaxel 80 mg/m^2|Alisertib 20 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1.
10995561|NCT01028131|EG002|Reported Event|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits. Clean samples (cotinine less than 100 ng/ml) will result in the immediate provision of a $50 Target gift card. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
10995562|NCT01028131|EG003|Reported Event|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
10995563|NCT01028222|BG000|Baseline|Nilotinib|400 mg twice daily
10995564|NCT01028222|BG001|Baseline|DTIC|850 mg/m2 IV every 3 weeks
10995565|NCT01028222|BG002|Baseline|Total|Total of all reporting groups
10995566|NCT01028222|FG000|Participant Flow|Nilotinib|400 mg twice daily
10995567|NCT01028222|FG001|Participant Flow|DTIC|850 mg/m2 IV every 3 weeks
10995568|NCT01028222|OG000|Outcome|Nilotinib|400 mg twice daily
10995569|NCT01028222|OG001|Outcome|DTIC|850 mg/m2 IV every 3 weeks
10995570|NCT01028222|EG000|Reported Event|Nilotinib|400 mg twice daily
10995571|NCT01028222|EG001|Reported Event|DTIC|850 mg/m2 IV every 3 weeks
10995572|NCT01028222|EG002|Reported Event|Crossover Nilotinib Treatment|Crossover nilotinib treatment
10995573|NCT01028352|BG000|Baseline|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
10995574|NCT01028352|FG000|Participant Flow|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
10995575|NCT01028352|OG000|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
10995576|NCT01028352|EG000|Reported Event|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
10995577|NCT01028378|BG000|Baseline|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
10995578|NCT01028378|FG000|Participant Flow|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
10995579|NCT01028378|OG000|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
10995580|NCT01028378|EG000|Reported Event|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
10995581|NCT01028391|BG000|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
10995582|NCT01028391|BG001|Baseline|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
10995583|NCT01028391|BG002|Baseline|Total|Total of all reporting groups
10995584|NCT01028391|FG000|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
10995585|NCT01028391|FG001|Participant Flow|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
10995586|NCT01028391|OG000|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
11223542|NCT02354378|EG001|Reported Event|Children Not Undergoing Sedation|"A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing.~Memory Test"
10995587|NCT01028391|OG001|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
10995588|NCT01028391|EG000|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
10995589|NCT01028391|EG001|Reported Event|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
10995590|NCT01028560|BG000|Baseline|No Immunotherapy, Receive Standard of Care Asthma Treatment|"This group only receives standard of care asthma and allergy treatment. This does not receive allergy immunotherapy.~Both the experimental group and the control group receive otherwise standard of care asthma and allergy treatment."
10995591|NCT01028560|BG001|Baseline|Allergen Immunotherapy|"This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment~Allergen extracts (subcutaneous injections): Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-3 injections until a predetermined maintenance dose is reached. For safety, the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase.~Both the experimental group and the control group receive otherwise standard of care asthma and allergy treatment."
10995592|NCT01028560|BG002|Baseline|Total|Total of all reporting groups
10995593|NCT01028560|FG000|Participant Flow|No Immunotherapy, Receive Standard of Care Asthma Treatment|"This group consists of children who do not receive allergy immunotherapy. No placebo injections were used. The control group received standard of care asthma and allergy treatment, excluding allergy immunotherapy (subcutaneous or other routes).~Standard of care: standard of care asthma and allergy treatment (medications, advice to environmental remediation)"
10995594|NCT01028560|FG001|Participant Flow|Allergen Immunotherapy|"This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy, this group receives standard of care asthma and allergy treatment (medications, advice to environmental remediation)~Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-3 injections until a predetermined maintenance dose is reached. This maintenance dose varies by extract and accords to the general practice guidelines of immunotherapy. To increase safety, the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase.~Standard of care: standard of care asthma and allergy treat"
10995595|NCT01028560|OG000|Outcome|No Immunotherapy, Receive Standard of Care Asthma Treatment|"This group only receives standard of care asthma and allergy treatment. This does not receive allergy immunotherapy.~Both the experimental group and the control group receive otherwise standard of care asthma and allergy treatment."
10995596|NCT01028560|OG001|Outcome|Allergen Immunotherapy|"This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment~Allergen extracts (subcutaneous injections): Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-3 injections until a predetermined maintenance dose is reached. For safety, the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase.~Both the experimental group and the control group receive otherwise standard of care asthma and allergy treatment."
10995597|NCT01028560|OG001|Outcome|Allergen Immunotherapy|"This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment.~Allergen extracts (subcutaneous injections): Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-3 injections until a predetermined maintenance dose is reached. For safety, the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase.~Both the experimental group and the control group receive otherwise standard of care asthma and allergy treatment."
10995598|NCT01028560|EG000|Reported Event|No Immunotherapy, Receive Standard of Care Asthma Treatment|"This group consists of children who do not receive allergy immunotherapy. Both groups - the experimental as well as the control group receive otherwise standard of care asthma and allergy treatment~Standard of care: standard of care asthma and allergy treatment"
11007562|NCT01091428|OG002|Outcome|Alisertib 20 mg BID + Paclitaxel 60 mg/m^2|Alisertib 20 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1.
11007563|NCT01091428|OG003|Outcome|Alisertib 30 mg BID + Paclitaxel 60 mg/m^2|Alisertib 30 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase
10995599|NCT01028560|EG001|Reported Event|Allergen Immunotherapy|"This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment~Allergen extracts (subcutaneous injections): Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-3 injections until a predetermined maintenance dose is reached. This maintenance dose varies by extract and accords to the general practice guidelines of immunotherapy. To increase safety the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase.~Standard of care: standard of care asthma and allergy treat"
10995600|NCT01028651|BG000|Baseline|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
10995601|NCT01028651|FG000|Participant Flow|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
10995602|NCT01028651|OG000|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
10995603|NCT01028651|OG000|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
10995604|NCT01028651|OG001|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
10995605|NCT01028651|EG000|Reported Event|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
10995606|NCT01028677|BG000|Baseline|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
10995607|NCT01028677|BG001|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
10995608|NCT01028677|BG002|Baseline|Total|Total of all reporting groups
10995609|NCT01028677|FG000|Participant Flow|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
10995610|NCT01028677|FG001|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 6 weeks"
10995611|NCT01028677|OG000|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
10995612|NCT01028677|OG001|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
10995613|NCT01028677|EG000|Reported Event|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
10995614|NCT01028677|EG001|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
10995615|NCT01028820|BG000|Baseline|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
10995616|NCT01028820|FG000|Participant Flow|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
10995617|NCT01028820|OG000|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
10995618|NCT01028820|OG001|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
10995619|NCT01028820|EG000|Reported Event|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
10995620|NCT01028911|BG000|Baseline|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator's discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
11223543|NCT02354417|BG000|Baseline|ProHema-CB|"All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.~ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:~For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.~For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.~Biological: ProHema-CB: Each subject will receive one administration of ProHema-CB unit transplant."
11223544|NCT02354417|FG000|Participant Flow|ProHema-CB|"All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.~ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:~For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.~For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.~Biological: ProHema-CB: Each subject will receive o"
11223545|NCT02354417|OG000|Outcome|ProHema-CB|"All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.~ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:~For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.~For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.~Biological: ProHema-CB: Each subject will receive one administration of ProHema-CB unit transplant."
11223546|NCT02354417|EG000|Reported Event|ProHema-CB|"All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.~ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:~For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.~For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.~Biological: ProHema-CB: Each subject will receive o"
11223547|NCT02354443|BG000|Baseline|ProHema-CB|"ProHema-CB represents Ex Vivo Modulated Human Cord Blood Cells. Each subject will receive one administration of ProHema-CB unit transplant.~ProHema-CB Transplant: ProHema-CB, the cellular product, represents the cell populations contained within a human UCB unit after modulation on the day of transplantation by an ex vivo incubation process with the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 (also referred to as FT1050). The cell populations include hematopoietic stem and progenitor cells."
11223548|NCT02354443|FG000|Participant Flow|ProHema-CB|"ProHema-CB represents Ex Vivo Modulated Human Cord Blood Cells. Each subject will receive one administration of ProHema-CB unit transplant.~ProHema-CB Transplant: ProHema-CB, the cellular product, represents the cell populations contained within a human UCB unit after modulation on the day of transplantation by an ex vivo incubation process with the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 (also referred to as FT1050). The cell populations include hematopoietic stem and progenitor cells."
11223549|NCT02354443|OG000|Outcome|ProHema-CB|"ProHema-CB represents Ex Vivo Modulated Human Cord Blood Cells. Each subject will receive one administration of ProHema-CB unit transplant.~ProHema-CB Transplant: ProHema-CB, the cellular product, represents the cell populations contained within a human UCB unit after modulation on the day of transplantation by an ex vivo incubation process with the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 (also referred to as FT1050). The cell populations include hematopoietic stem and progenitor cells."
11223550|NCT02354443|EG000|Reported Event|ProHema-CB|"ProHema-CB represents Ex Vivo Modulated Human Cord Blood Cells. Each subject will receive one administration of ProHema-CB unit transplant.~ProHema-CB Transplant: ProHema-CB, the cellular product, represents the cell populations contained within a human UCB unit after modulation on the day of transplantation by an ex vivo incubation process with the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 (also referred to as FT1050). The cell populations include hematopoietic stem and progenitor cells."
11223551|NCT02354482|BG000|Baseline|Participants Recieving Transitional Care Strategies|Participants received one or more of 5 transitional care strategies, or were part of a reference group that received no specific transitional care strategy.
11223552|NCT02354482|FG000|Participant Flow|Participants Receiving Transitional Care Strategies|Participants were exposed to one or more of five different transitional care strategies, or were part of a reference group that did not receive a specific transitional care strategy.
11223553|NCT02354482|OG000|Outcome|Patient Communication and Care Management|"Participants received one more transitional care strategies.~Patient Communication and Care Management: Received the following Transitional Care strategies:~Helpful Health Care Contact OR Symptom Management~Post-discharge Care Consultation~Patient Goal/Preference Assessment~Plain Language Communication in Hospital~Plain Language Communication at Home~Transition Summary for Patients and Family Caregivers"
11223554|NCT02354482|OG001|Outcome|Home-Based Trust, Plain Language, and Coordination|"Participants received one more transitional care strategies.~Home-Based Trust, Plain Language, and Coordination: Received the following Transitional Care Strategies:~Transition Team~Home visits~Plain Language Communication at Home~Promote Trust at Home~Referral to Community Services~Follow-up Appointment"
11336448|NCT03566810|FG002|Participant Flow|First Test GXR (Fed), Then Reference GXR (Fed)|Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong, China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GXR (Merck Darmstadt, Germany) on Day 8 in treatment period 2 under fed conditions. There was a wash-out period of 7 days between each treatment period.
10995621|NCT01028911|BG001|Baseline|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
11223555|NCT02354482|OG002|Outcome|Hospital-Based Trust, Plain Language, and Coordination|"Participants received one more transitional care strategies.~Hospital-Based Trust, Plain Language, and Coordination: Received the following Transitional Care Strategies:~Post-discharge care consultation~Identify High-Risk Patients and Intervene~Medication Reconciliation~Plain Language Communication in Hospital~Promote Trust in the Hospital~Transition Summary for Patients and Family Caregivers"
11223556|NCT02354482|OG003|Outcome|Patient/Family Caregiver Assessment and Information Exchange a|"Participants received one more transitional care strategies.~Patient/Family Caregiver Assessment and Information Exchange among Providers: Received the following Transitional Care Strategies:~Patient Goal/Preference Assessment~Identify High-Risk Patients and Intervene~Timely Exchange of Critical Patient Information among Providers~Patient/Family Caregiver Transitional Care Needs Assessment"
11223557|NCT02354482|OG004|Outcome|Assessment and Teach Back|"Participants received one more transitional care strategies.~Assessment and Teach Back: Received the following Transitional Care Strategies:~Post-discharge care consultation~Language Assessment~Teach Back for Information and Skills"
11223558|NCT02354482|OG005|Outcome|Reference|"Participants were not involved in a specific transitional care strategy.~Standard of Care: No specific Transitional Care Strategy"
11223559|NCT02354482|EG000|Reported Event|Patient Communication and Care Management|"Participants received one more transitional care strategies.~Patient Communication and Care Management: Received the following Transitional Care strategies:~Helpful Health Care Contact OR Symptom Management~Post-discharge Care Consultation~Patient Goal/Preference Assessment~Plain Language Communication in Hospital~Plain Language Communication at Home~Transition Summary for Patients and Family Caregivers"
11223560|NCT02354482|EG001|Reported Event|Home-Based Trust, Plain Language, and Coordination|"Participants received one more transitional care strategies.~Home-Based Trust, Plain Language, and Coordination: Received the following Transitional Care Strategies:~Transition Team~Home visits~Plain Language Communication at Home~Promote Trust at Home~Referral to Community Services~Follow-up Appointment"
11223561|NCT02354482|EG002|Reported Event|Hospital-Based Trust, Plain Language, and Coordination|"Participants received one more transitional care strategies.~Hospital-Based Trust, Plain Language, and Coordination: Received the following Transitional Care Strategies:~Post-discharge care consultation~Identify High-Risk Patients and Intervene~Medication Reconciliation~Plain Language Communication in Hospital~Promote Trust in the Hospital~Transition Summary for Patients and Family Caregivers"
11223562|NCT02354482|EG003|Reported Event|Patient/Family Caregiver Assessment and Information Exchange a|"Participants received one more transitional care strategies.~Patient/Family Caregiver Assessment and Information Exchange among Providers: Received the following Transitional Care Strategies:~Patient Goal/Preference Assessment~Identify High-Risk Patients and Intervene~Timely Exchange of Critical Patient Information among Providers~Patient/Family Caregiver Transitional Care Needs Assessment"
11223563|NCT02354482|EG004|Reported Event|Assessment and Teach Back|"Participants received one more transitional care strategies.~Assessment and Teach Back: Received the following Transitional Care Strategies:~Post-discharge care consultation~Language Assessment~Teach Back for Information and Skills"
11223564|NCT02354482|EG005|Reported Event|Reference|"Participants were not involved in a specific transitional care strategy.~Standard of Care: No specific Transitional Care Strategy"
11223565|NCT02354508|BG000|Baseline|Lanreotide 120 mg|Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
11223566|NCT02354508|BG001|Baseline|Octreotide 30 mg|Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
10995622|NCT01028911|BG002|Baseline|Total|Total of all reporting groups
11223567|NCT02354508|BG002|Baseline|Octreotide 40 mg|Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
11223568|NCT02354508|BG003|Baseline|Total|Total of all reporting groups
11223569|NCT02354508|FG000|Participant Flow|Lanreotide 120 mg|Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
11223570|NCT02354508|FG001|Participant Flow|Octreotide 30 mg|Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
11223571|NCT02354508|FG002|Participant Flow|Octreotide 40 mg|Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
11223572|NCT02354508|OG000|Outcome|Lanreotide 120 mg|Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
11223573|NCT02354508|OG001|Outcome|Octreotide 30 mg|Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
11223574|NCT02354508|OG002|Outcome|Octreotide 40 mg|Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
11223575|NCT02354508|OG003|Outcome|Pasireotide LAR Overall|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
11007564|NCT01091428|OG004|Outcome|Alisertib 40 mg BID + Paclitaxel 60 mg/m^2|Alisertib 10 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1.
11223576|NCT02354508|OG000|Outcome|Up-titrated to Pasireotide LAR 60 mg|This is the subset of participants in the FAS who started treatment with 40 mg pasireotide LAR in the core phase and were up-titrated to pasireotide LAR 60 mg.
11223577|NCT02354508|OG000|Outcome|Pasireotide LAR Overall|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
11223578|NCT02354508|OG003|Outcome|Pasireotide LAR Monotherapy|Participants received pasireotide LAR only
11223579|NCT02354508|OG004|Outcome|Pasireotide With Concomitant Medication|Participants received pasireotide along with other concomitant medications.or octreotide 40 mg.
11223580|NCT02354508|OG005|Outcome|Pasireotide LAR Overall|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
11223581|NCT02354508|OG000|Outcome|Up-titrated to Pasireotide LAR 60 mg|This is the subset of participants in the Extension FAS who started treatment with 40 mg pasireotide LAR in the extension phase and were up-titrated to pasireotide LAR 60 mg.
11223582|NCT02354508|OG000|Outcome|Pasireotide LAR (run-in Phase)|Participants who were part of the run-in phase, i.e. group 1)
10995623|NCT01028911|FG000|Participant Flow|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator's discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
10995624|NCT01028911|FG001|Participant Flow|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
10995625|NCT01028911|OG000|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator's discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
10995626|NCT01028911|OG001|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
10995627|NCT01028911|EG000|Reported Event|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator's discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
10995628|NCT01028911|EG001|Reported Event|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
10995629|NCT01028937|BG000|Baseline|Hyperopia|Hyperopia treatment
10995630|NCT01028937|FG000|Participant Flow|Hyperopia|"The NTK Optimal Keratoplasty System/Procedure is indicated for the temporary improvement of distance uncorrected visual acuity (in patient eyes that have manifest refraction, spherical equivalent equal to +1.0 to +2.5 Diopters, with less than or equal to 0.75 Diopters of refractive astigmatism (minus cylinder format) and with uncorrected distance visual acuity less than 20/40 but greater than or equal to 20/80. Patients must be at least 40 years of age with a documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.5 Diopters in MRSE. The magnitude of D-UCVA improvement by Opti-K treatment may diminish over time, caused by some regression of effect in addition to natural progressive loss of accommodation and, for most patients, progressive hyperopic shift with increasing age.~Optimal Keratoplasty: Laser treatment in 16 spots at treatment energy densities up to 48 mJ per spot"
10995631|NCT01028937|OG000|Outcome|Treatment Group|Eyes that underwent Opti-K treatment
10995632|NCT01028937|EG000|Reported Event|Hyperopia|"The NTK Optimal Keratoplasty System/Procedure is indicated for the temporary improvement of distance uncorrected visual acuity (in patient eyes that have manifest refraction, spherical equivalent equal to +1.0 to +2.5 Diopters, with less than or equal to 0.75 Diopters of refractive astigmatism (minus cylinder format) and with uncorrected distance visual acuity less than 20/40 but greater than or equal to 20/80. Patients must be at least 40 years of age with a documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.5 Diopters in MRSE. The magnitude of D-UCVA improvement by Opti-K treatment may diminish over time, caused by some regression of effect in addition to natural progressive loss of accommodation and, for most patients, progressive hyperopic shift with increasing age.~Optimal Keratoplasty: Laser treatment in 16 spots at treatment energy densities up to 48 mJ per spot"
10995633|NCT01029054|BG000|Baseline|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
10995634|NCT01029054|FG000|Participant Flow|Dose Escalation Cohort 1|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 20 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
11223583|NCT02354508|OG001|Outcome|Pasireotide LAR Overall|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
11223584|NCT02354508|OG000|Outcome|GH: ≥1 - ≤ 2.5 μg/L|These Participants had this GH level at screening
11223585|NCT02354508|OG001|Outcome|GH: > 2.5 μg/L|These Participants had this GH level at screening
11223586|NCT02354508|OG002|Outcome|GH: Missing|These Participants were missing GH levels at screening
11223587|NCT02354508|OG003|Outcome|Pasireotide LAR Overall|This is the total sum of participants with at screening with various or missing GH levels
11223588|NCT02354508|OG000|Outcome|Diabetic|Participants who were diabetic in the Pasireotide LAR overall group
11223589|NCT02354508|OG001|Outcome|Pre-diabetic|Participants who were pre-diabetic in the Pasireotide LAR overall group
11223590|NCT02354508|OG002|Outcome|Non-diabetic|Participants who were non-diabetic in the Pasireotide LAR overall group
11223591|NCT02354508|OG000|Outcome|Pasireotide LAR Overall - AcroQOL Total Scores|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
10995635|NCT01029054|FG001|Participant Flow|Dose Escalation Cohort 2|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 27 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
10995636|NCT01029054|FG002|Participant Flow|Dose Escalation Cohort 3|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 36 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
10995637|NCT01029054|OG000|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
10995638|NCT01029054|EG000|Reported Event|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
10995639|NCT01029262|BG000|Baseline|Placebo|Participants received 3 placebo capsules by mouth daily for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
10995640|NCT01029262|BG001|Baseline|Lenalidomide|"Participants receieved lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
10995641|NCT01029262|BG002|Baseline|Total|Total of all reporting groups
10995642|NCT01029262|FG000|Participant Flow|Placebo|Participants received 3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
10995643|NCT01029262|FG001|Participant Flow|Lenalidomide|"Participants received lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Participants received lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
10995644|NCT01029262|OG000|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
10995645|NCT01029262|OG001|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
10995646|NCT01029262|OG000|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects.
10995647|NCT01029262|OG001|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min.~."
10995648|NCT01029262|OG001|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
10995649|NCT01029262|OG000|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects or withdrawal of consent.
10995650|NCT01029262|OG001|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.~."
10995651|NCT01029262|EG000|Reported Event|Placebo|Participants received 3 placebo capsules by mouth QD for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent
10995652|NCT01029262|EG001|Reported Event|Lenalidomide|Participants received lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min.
10995653|NCT01029340|BG000|Baseline|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
10995654|NCT01029340|BG001|Baseline|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
10995655|NCT01029340|BG002|Baseline|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months
11007565|NCT01091428|OG005|Outcome|Alisertib 50 mg BID + Paclitaxel 60 mg/m^2|Alisertib 10 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1
10995656|NCT01029340|BG003|Baseline|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia for 6 months
10995657|NCT01029340|BG004|Baseline|Arm 5: Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
10995658|NCT01029340|BG005|Baseline|Total|Total of all reporting groups
10995659|NCT01029340|FG000|Participant Flow|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
10995660|NCT01029340|FG001|Participant Flow|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
11223592|NCT02354508|OG001|Outcome|Pasireotide LAR Overall - AcroQOL Physical Sub-scores|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
11223593|NCT02354508|OG002|Outcome|Pasireotide LAR Overall - AcroQOL Psychological Sub-scores|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
10995661|NCT01029340|FG002|Participant Flow|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
10995662|NCT01029340|FG003|Participant Flow|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia (CS/EP) for 6 months
10995663|NCT01029340|FG004|Participant Flow|Arm 5: Recombinant Factor VIII by CS/EP|Part C - Arm 5: Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
10995664|NCT01029340|FG005|Participant Flow|Arm 6: Recombinant Factor VIII (BAY81-8973) Part B + Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
10995665|NCT01029340|OG000|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
10995666|NCT01029340|OG001|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
10995667|NCT01029340|OG000|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
10995668|NCT01029340|OG000|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
10995669|NCT01029340|OG001|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
10995670|NCT01029340|OG000|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
10995671|NCT01029340|OG000|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
10995672|NCT01029340|EG000|Reported Event|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
10995673|NCT01029340|EG001|Reported Event|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
10995674|NCT01029340|EG002|Reported Event|Recombinant Factor VIII (BAY81-8973) Part B and Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
10995675|NCT01029340|EG003|Reported Event|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants in Part C received a loading dose of approximately 50 IU/kg of BAY81-8973 (nearest whole vial amount) for less than 15 minutes before the first surgical incision. Then they received further treatment with BAY81-8973 according to surgical requirements up to 3 weeks.
10995676|NCT01029353|BG000|Baseline|Randomized Trial: Initial Laparotomy|Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
10995677|NCT01029353|BG001|Baseline|Randomized Trial: Initial Peritoneal Drain|Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
11223594|NCT02354508|OG003|Outcome|Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
11223595|NCT02354508|OG004|Outcome|Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
10995678|NCT01029353|BG002|Baseline|Preference Cohort: Initial Laparotomy|Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
10995679|NCT01029353|BG003|Baseline|Preference Cohort: Initial Peritoneal Drain|Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
10995680|NCT01029353|BG004|Baseline|Total|Total of all reporting groups
10995681|NCT01029353|FG000|Participant Flow|Randomized Trial: Initial Laparotomy|Under general anesthesia in the neonatal intensive care unit (NICU) or operating room, a laparotomy will be performed following standard procedures.
10995682|NCT01029353|FG001|Participant Flow|Randomized Trial: Initial Peritoneal Drain|Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
10995683|NCT01029353|FG002|Participant Flow|Preference Cohort: Initial Laparotomy|Under general anesthesia in the neonatal intensive care unit (NICU) or operating room, a laparotomy will be performed following standard procedures.
10995684|NCT01029353|FG003|Participant Flow|Preference Cohort: Initial Peritoneal Drain|Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
10995685|NCT01029353|OG000|Outcome|Randomized Trial: Initial Laparotomy|Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
10995686|NCT01029353|OG001|Outcome|Randomized Trial: Initial Peritoneal Drain|Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
10995687|NCT01029353|OG002|Outcome|Preference Cohort: Laparotomy|Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
10995688|NCT01029353|OG003|Outcome|Preference Cohort: Initial Peritoneal Drain|Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
10995689|NCT01029353|EG000|Reported Event|Randomized Trial: Initial Laparotomy|Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
10995690|NCT01029353|EG001|Reported Event|Randomized Trial: Initial Peritoneal Drain|Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
10995691|NCT01029353|EG002|Reported Event|Preference Cohort: Initial Laparotomy|Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
10995692|NCT01029353|EG003|Reported Event|Preference Cohort: Initial Peritoneal Drain|Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
10995693|NCT01029366|BG000|Baseline|CLL Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy
10995694|NCT01029366|BG001|Baseline|ALL Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy
11223596|NCT02354508|OG000|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Headache|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
10995695|NCT01029366|BG002|Baseline|Total|Total of all reporting groups
10995696|NCT01029366|FG000|Participant Flow|Chronic Lymphocytic Leukemia (CLL) Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy. Subjects were given minimum/maximum total dose: 1.5x10⁷/ 5x10⁹.
10995697|NCT01029366|FG001|Participant Flow|Acute Lymphocytic Leukemia (ALL) Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy. Subjects were given minimum/maximum total dose: 1.5x10⁷/ 5x10⁹
10995698|NCT01029366|OG000|Outcome|All Participants|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
10995699|NCT01029366|OG000|Outcome|CLL Subjects|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity~laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
10995700|NCT01029366|OG001|Outcome|ALL Subjects|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity~laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
10995701|NCT01029366|EG000|Reported Event|Chronic Lymphocytic Leukemia|CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10^7 / 5x10^9.
11223597|NCT02354508|OG001|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Fatigue|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
11223598|NCT02354508|OG002|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Perspiration|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
10995702|NCT01029366|EG001|Reported Event|Acute Lymphocytic Leukemia|CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10^7 / 5x10^9.
10995703|NCT01029392|BG000|Baseline|Those Requiring Vit D Supplement|"Those who had a Vit D level of < 30~Vitamin D: 2000iu once a day"
10995704|NCT01029392|BG001|Baseline|No Vit D Supplementation|Normal vitamin D levels No Vitamin D supplement
10995705|NCT01029392|BG002|Baseline|Total|Total of all reporting groups
10995706|NCT01029392|FG000|Participant Flow|Vitamin D Supplement|"Those who had a Vit D level of < 30 ng/mKL~Vitamin D: 2000 IU once a day"
10995707|NCT01029392|FG001|Participant Flow|No Vitamin D Supplementation|Screening vitamin D level in normal range for children (50-80 ng.mL)
10995708|NCT01029392|OG000|Outcome|Those Requiring Vit D Supplement|Those who had a Vit D level of < 30 Vitamin D: 2000iu once a day
11223599|NCT02354508|OG003|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
10995709|NCT01029392|OG001|Outcome|No Vitamin D Supplementation|Those with normal vitamin D levels (50-80 ng/mL) No vitamin D supplemenation
10995710|NCT01029392|OG000|Outcome|Vitamin D Supplement|"Those who had a Vit D level of < 30 ng/mKL~Vitamin D: 2000 IU once a day"
10995711|NCT01029392|OG001|Outcome|No Vitamin D Supplementation|Screening vitamin D level in normal range for children (50-80 ng.mL)
10995712|NCT01029392|EG000|Reported Event|Those Requiring Vit D Supplement|Those who had a Vit D level of < 30 ng/mL Vitamin D: 2000iu once a day
10995713|NCT01029392|EG001|Reported Event|No Vit D Supplementation|Normal vitamin D levels (50-80 ng/mL) No vitamin D supplementation
10995714|NCT01029405|BG000|Baseline|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995715|NCT01029405|BG001|Baseline|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995716|NCT01029405|BG002|Baseline|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995717|NCT01029405|BG003|Baseline|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995718|NCT01029405|BG004|Baseline|Total|Total of all reporting groups
10995719|NCT01029405|FG000|Participant Flow|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent (%) and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995720|NCT01029405|FG001|Participant Flow|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995721|NCT01029405|FG002|Participant Flow|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995722|NCT01029405|FG003|Participant Flow|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995723|NCT01029405|OG000|Outcome|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995724|NCT01029405|OG000|Outcome|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995725|NCT01029405|OG001|Outcome|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995726|NCT01029405|OG002|Outcome|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995727|NCT01029405|EG000|Reported Event|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995728|NCT01029405|EG001|Reported Event|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
11223600|NCT02354508|OG004|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Paresthesiae|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
10995729|NCT01029405|EG002|Reported Event|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995730|NCT01029405|EG003|Reported Event|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10995731|NCT01029535|BG000|Baseline|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
10995732|NCT01029535|FG000|Participant Flow|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
10995733|NCT01029535|OG000|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
10995734|NCT01029535|EG000|Reported Event|Juvederm® VOLUMA™_Phase 1|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
11223601|NCT02354508|OG004|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae|This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
11223602|NCT02354508|OG000|Outcome|Pasireotide LAR Overall|These are the participants in the extension phase who received Pasireotide LAR
11223603|NCT02354508|OG000|Outcome|Pasireotide LAR Monotherapy|These Participants were treated with pasireotide LAR only in the extension phase
11223604|NCT02354508|OG001|Outcome|Pasireotide With Concomitant Mediaction|These Participants were treated with pasireotide LAR as well as other concomitant medications in the extension phase
10995735|NCT01029535|EG001|Reported Event|Juvederm® VOLUMA™_Phase 2|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
10995736|NCT01029587|BG000|Baseline|Eculizumab|Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
10995737|NCT01029587|FG000|Participant Flow|Eculizumab|Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
10995738|NCT01029587|OG000|Outcome|Eculizumab|Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
10995739|NCT01029587|EG000|Reported Event|Eculizumab|Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
10995740|NCT01029652|BG000|Baseline|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
11007566|NCT01091428|OG000|Outcome|Alisertib 40 mg BID + Paclitaxel 60 mg/m^2 (Phase 2)|Alisertib 40 mg, orally, BID on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2 (Up to 28 cycles).
11007567|NCT01091428|EG000|Reported Event|Alisertib (Phase 1 - Ovarian Cancer)|Alisertib (MLN8237) 10 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1.
11223605|NCT02354508|OG002|Outcome|Pasireotide LAR Overall|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223606|NCT02354508|OG000|Outcome|Pasireotide LAR Overall - AcroQOL Total Scores|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223607|NCT02354508|OG001|Outcome|Pasireotide LAR Overall - AcroQOL Physical Sub-scores|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223608|NCT02354508|OG002|Outcome|Pasireotide LAR Overall - AcroQOL Psychological Sub-scores|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223609|NCT02354508|OG003|Outcome|Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223610|NCT02354508|OG004|Outcome|Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223611|NCT02354508|OG000|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Headache|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223612|NCT02354508|OG001|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Fatigue|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223613|NCT02354508|OG002|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Perspiration|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223614|NCT02354508|OG003|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
10995741|NCT01029652|BG001|Baseline|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
10995742|NCT01029652|BG002|Baseline|Total|Total of all reporting groups
10995743|NCT01029652|FG000|Participant Flow|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study"
10995744|NCT01029652|FG001|Participant Flow|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. No patient received triamcinolone acetonide in second extension Study ."
10995745|NCT01029652|OG000|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
10995746|NCT01029652|OG001|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
10995747|NCT01029652|OG000|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
10995748|NCT01029652|OG001|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
10995749|NCT01029652|OG001|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
10995750|NCT01029652|OG001|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
11007568|NCT01091428|EG001|Reported Event|Alisertib (Phase 1 - Breast Cancer)|Alisertib 20 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1.
11223615|NCT02354508|OG004|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Paresthesiae|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223616|NCT02354508|OG004|Outcome|Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae|This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
11223617|NCT02354508|EG000|Reported Event|Up-titrated to Pasireotide LAR 60 mg|Patients not achieving biochemical control and were up-titrated to pasireotide LAR 60 mg.
11223618|NCT02354508|EG001|Reported Event|Pasireotide LAR Overall|This is the sum total of participants in under the previous treatments in the Core phase: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg or who were treated with at least one dose of pasireotide LAR in the extension phase
11223619|NCT02354534|BG000|Baseline|50 mg Artesunate Suppositories, 1 Cycle|"Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223620|NCT02354534|BG001|Baseline|200 mg Artesunate Suppositories, 1 Cycle|"Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223621|NCT02354534|BG002|Baseline|200 mg Artesunate Suppositories,2 Cycles|"Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223622|NCT02354534|BG003|Baseline|200 mg Artesunate Suppositories,3 Cycles|"Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223623|NCT02354534|BG004|Baseline|Total|Total of all reporting groups
11223624|NCT02354534|FG000|Participant Flow|50 mg Artesunate Suppositories, 1 Cycle|"Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223625|NCT02354534|FG001|Participant Flow|200 mg Artesunate Suppositories, 1 Cycle|"Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223626|NCT02354534|FG002|Participant Flow|200 mg Artesunate Suppositories,2 Cycles|"Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223627|NCT02354534|FG003|Participant Flow|200 mg Artesunate Suppositories,3 Cycles|"Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
10877206|NCT00445744|BG000|Baseline|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
10877207|NCT00445744|FG000|Participant Flow|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
11223628|NCT02354534|OG000|Outcome|50 mg Artesunate Suppositories, 1 Cycle|"Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223629|NCT02354534|OG001|Outcome|200 mg Artesunate Suppositories, 1 Cycle|"Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223630|NCT02354534|OG002|Outcome|200 mg Artesunate Suppositories,2 Cycles|"Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223631|NCT02354534|OG003|Outcome|200 mg Artesunate Suppositories,3 Cycles|"Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223632|NCT02354534|EG000|Reported Event|50 mg Artesunate Suppositories, 1 Cycle|"Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223633|NCT02354534|EG001|Reported Event|200 mg Artesunate Suppositories, 1 Cycle|"Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223634|NCT02354534|EG002|Reported Event|200 mg Artesunate Suppositories,2 Cycles|"Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223635|NCT02354534|EG003|Reported Event|200 mg Artesunate Suppositories,3 Cycles|"Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).~Artesunate Suppositories"
11223636|NCT02354586|BG000|Baseline|Niraparib 300 mg|Participants received Niraparib (300 milligram [mg], taken as 3 capsules of 100 mg once daily [QD]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
11223637|NCT02354586|FG000|Participant Flow|Niraparib 300 mg|Participants received Niraparib (300 milligram [mg], taken as 3 capsules of 100 mg once daily [QD]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
11223638|NCT02354586|OG000|Outcome|Niraparib 300 mg|Participants received Niraparib (300 milligram [mg], taken as 3 capsules of 100 mg once daily [QD]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
10877208|NCT00445744|OG000|Outcome|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
10877209|NCT00445744|EG000|Reported Event|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
10877210|NCT00445770|BG000|Baseline|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
10877211|NCT00445770|BG001|Baseline|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
10877212|NCT00445770|BG002|Baseline|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
10877213|NCT00445770|BG003|Baseline|Total|Total of all reporting groups
10877214|NCT00445770|FG000|Participant Flow|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
10877215|NCT00445770|FG001|Participant Flow|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
10877216|NCT00445770|FG002|Participant Flow|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
10877217|NCT00445770|OG000|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
10877218|NCT00445770|OG001|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
10877219|NCT00445770|OG002|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
10877220|NCT00445770|OG000|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
10877221|NCT00445770|OG001|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
10877222|NCT00445770|EG000|Reported Event|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
10877223|NCT00445770|EG001|Reported Event|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
10877224|NCT00445770|EG002|Reported Event|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
10877225|NCT00445848|BG000|Baseline|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
10877226|NCT00445848|FG000|Participant Flow|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
10877227|NCT00445848|OG000|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
10877228|NCT00445848|EG000|Reported Event|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
10877229|NCT00445887|BG000|Baseline|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
10877230|NCT00445887|BG001|Baseline|Arm II (Placebo)|Placebo for 4 to 6 weeks
10877231|NCT00445887|BG002|Baseline|Total|Total of all reporting groups
10877232|NCT00445887|FG000|Participant Flow|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
10877233|NCT00445887|FG001|Participant Flow|Arm II (Placebo)|Placebo for 4 to 6 weeks
10877234|NCT00445887|OG000|Outcome|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
10877235|NCT00445887|OG001|Outcome|Arm II (Placebo)|Placebo for 4 to 6 weeks
10877236|NCT00445887|OG000|Outcome|Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)|Number of patients on arm 1 who experienced a grade 1 event using CTCAE v 3.0
10877237|NCT00445887|OG001|Outcome|Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)|Number of patients on arm 1 who experienced a grade 2 event using CTCAE v 3.0
10877238|NCT00445887|OG002|Outcome|Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)|Number of patients on arm 1 who experienced a grade 3 event using CTCAE v 3.0
10877239|NCT00445887|OG003|Outcome|Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)|Number of patients on arm ! who experienced a grade 4 event using CTCAE v. 3.0
10877240|NCT00445887|OG004|Outcome|Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)|Number of patients on arm I who experienced a grade 5 event using CTCAE v. 3.0
10877241|NCT00445887|OG005|Outcome|Grade 1 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 1 event using CTCAE v.30
10877242|NCT00445887|OG006|Outcome|Grade 2 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 2 event using CTCAE 3.0
10877243|NCT00445887|OG007|Outcome|Grade 3 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 3 event using CTCAE 3.0
10877244|NCT00445887|OG008|Outcome|Grade 4 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 4 event using CTCAE 3.0
10877245|NCT00445887|OG009|Outcome|Grade 5 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 5 event using CTCAE 3.0
10877246|NCT00445887|EG000|Reported Event|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
10877247|NCT00445887|EG001|Reported Event|Arm II (Placebo)|Placebo for 4 to 6 weeks
10877248|NCT00445939|BG000|Baseline|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
10877249|NCT00445939|BG001|Baseline|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
10877250|NCT00445939|BG002|Baseline|Placebo|Placebo at Week 0, placebo Week 2
10877251|NCT00445939|BG003|Baseline|Total|Total of all reporting groups
10877252|NCT00445939|FG000|Participant Flow|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
10877253|NCT00445939|FG001|Participant Flow|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
10877254|NCT00445939|FG002|Participant Flow|Placebo|Placebo at Week 0, placebo at Week 2
10877255|NCT00445939|FG003|Participant Flow|Adalimumab 40mg /40 mg|Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6.
10877256|NCT00445939|OG000|Outcome|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
10877257|NCT00445939|OG001|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
10877258|NCT00445939|OG002|Outcome|Placebo|Placebo at Week 0, placebo at Week 2
10877259|NCT00445939|OG000|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
10877260|NCT00445939|OG002|Outcome|Placebo + 160/80 mg|Placebo at Week 0, placebo at Week 2
10877261|NCT00445939|OG002|Outcome|Placebo|Placebo at Week 0, placebo at Week 2,
10877262|NCT00445939|OG000|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
10877263|NCT00445939|OG001|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
10877264|NCT00445939|OG002|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, adalimumab 160 mg at Week 4, and adalimumab 80 mg at Week 6
10877265|NCT00445939|OG000|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
10877266|NCT00445939|OG001|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
10877267|NCT00445939|OG002|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
10877268|NCT00445939|EG000|Reported Event|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
10877269|NCT00445939|EG001|Reported Event|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
10877270|NCT00445939|EG002|Reported Event|Placebo|Placebo at Week 0, placebo at Week 2
10877271|NCT00445939|EG003|Reported Event|Adalimumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
10877272|NCT00445939|EG004|Reported Event|80/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
10877273|NCT00445939|EG005|Reported Event|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
10877274|NCT00445978|BG000|Baseline|Sapropterin Dihydrochloride|Sapropterin dihydrochloride: Subjects will receive oral tablets, once-daily (for 2.5, 5, 10mg/kg/day doses) or twice-daily (for the 20 mg/kg/day dose) of sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks as follows: 2.5, 5, 10, and 20 mg/kg/day.
10877275|NCT00445978|FG000|Participant Flow|Sapropterin Dihydrochloride|Sapropterin dihydrochloride: Subjects will receive oral tablets, once-daily (for 2.5, 5, 10mg/kg/day doses) or twice-daily (for the 20 mg/kg/day dose) of sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks as follows: 2.5, 5, 10, and 20 mg/kg/day. Prior to dose escalation, the investigator evaluated each subject's safety profile at the previous dose level to determine if the subject would escalate to the next dose level; maintain the same dose; or de-escalate to the previous dose.
10877276|NCT00445978|OG000|Outcome|Sapropterin Dihydrochloride 2.5 mg/kg/Day|Sapropterin dihydrochloride 2.5 mg/kg/day at Incidence
10877277|NCT00445978|OG001|Outcome|Sapropterin Dihydrochloride 5.0 mg/kg/Day|Sapropterin dihydrochloride 5.0 mg/kg/day at Incidence
10877278|NCT00445978|OG002|Outcome|Sapropterin Dihydrochloride 10.0 mg/kg/Day|Sapropterin dihydrochloride 10.0 mg/kg/day at Incidence
10877279|NCT00445978|OG003|Outcome|Sapropterin Dihydrochloride 20.0 mg/kg/Day|Sapropterin dihydrochloride 20.0 mg/kg/day at Incidence
10877280|NCT00445978|OG000|Outcome|Sapropterin Dihydrochloride|Sapropterin dihydrochloride: Subjects will receive oral tablets, once-daily (for 2.5, 5, 10mg/kg/day doses) or twice-daily (for the 20 mg/kg/day dose) of sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks as follows: 2.5, 5, 10, and 20 mg/kg/day.
10877281|NCT00445978|EG000|Reported Event|Sapropterin Dihydrochloride 2.5 mg/kg/Day|Sapropterin dihydrochloride 2.5 mg/kg/day at Incidence
10877282|NCT00445978|EG001|Reported Event|Sapropterin Dihydrochloride 5.0 mg/kg/Day|Sapropterin dihydrochloride 5.0 mg/kg/day at Incidence
10877283|NCT00445978|EG002|Reported Event|Sapropterin Dihydrochloride 10.0 mg/kg/Day|Sapropterin dihydrochloride 10.0 mg/kg/day at Incidence
10877284|NCT00445978|EG003|Reported Event|Sapropterin Dihydrochloride 20.0 mg/kg/Day|Sapropterin dihydrochloride 20.0 mg/kg/day at Incidence
10877285|NCT00446030|BG000|Baseline|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
10877286|NCT00446030|BG001|Baseline|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
10877287|NCT00446030|BG002|Baseline|Total|Total of all reporting groups
10877288|NCT00446030|FG000|Participant Flow|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
10877289|NCT00446030|FG001|Participant Flow|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
10877290|NCT00446030|OG000|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
10877291|NCT00446030|OG001|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
10877292|NCT00446030|EG000|Reported Event|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
10877293|NCT00446030|EG001|Reported Event|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
10877294|NCT00446095|BG000|Baseline|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
10877295|NCT00446095|BG001|Baseline|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
10877296|NCT00446095|BG002|Baseline|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
10877297|NCT00446095|BG003|Baseline|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
10877298|NCT00446095|BG004|Baseline|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
10877299|NCT00446095|BG005|Baseline|Total|Total of all reporting groups
10877300|NCT00446095|FG000|Participant Flow|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
10877301|NCT00446095|FG001|Participant Flow|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
10877302|NCT00446095|FG002|Participant Flow|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
10877303|NCT00446095|FG003|Participant Flow|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
10877304|NCT00446095|FG004|Participant Flow|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
10877305|NCT00446095|OG000|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
10877306|NCT00446095|OG001|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
10877307|NCT00446095|OG002|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
10877308|NCT00446095|OG003|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
10877309|NCT00446095|EG000|Reported Event|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
10877310|NCT00446095|EG001|Reported Event|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
10877311|NCT00446095|EG002|Reported Event|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
10877312|NCT00446095|EG003|Reported Event|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
10877313|NCT00446095|EG004|Reported Event|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
10877314|NCT00446134|BG000|Baseline|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877315|NCT00446134|BG001|Baseline|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877316|NCT00446134|BG002|Baseline|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877317|NCT00446134|BG003|Baseline|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877318|NCT00446134|BG004|Baseline|Total|Total of all reporting groups
10877319|NCT00446134|FG000|Participant Flow|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877320|NCT00446134|FG001|Participant Flow|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877321|NCT00446134|FG002|Participant Flow|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877322|NCT00446134|FG003|Participant Flow|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10995751|NCT01029652|OG001|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. Note that flare rate was calculated using only those new flares before switching."
10995752|NCT01029652|OG000|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
10995753|NCT01029652|OG001|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
10995754|NCT01029652|OG000|Outcome|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
10995755|NCT01029652|OG001|Outcome|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
10995756|NCT01029652|OG002|Outcome|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
11223639|NCT02354586|EG000|Reported Event|Niraparib 300 mg|Participants received Niraparib (300 milligram [mg], taken as 3 capsules of 100 mg once daily [QD]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
10995757|NCT01029652|OG003|Outcome|Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
11223640|NCT02354599|BG000|Baseline|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
10995758|NCT01029652|OG004|Outcome|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
11223641|NCT02354599|BG001|Baseline|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223642|NCT02354599|BG002|Baseline|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223643|NCT02354599|BG003|Baseline|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223644|NCT02354599|BG004|Baseline|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223645|NCT02354599|BG005|Baseline|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223646|NCT02354599|BG006|Baseline|Total|Total of all reporting groups
11223647|NCT02354599|FG000|Participant Flow|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223648|NCT02354599|FG001|Participant Flow|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223649|NCT02354599|FG002|Participant Flow|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223650|NCT02354599|FG003|Participant Flow|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223651|NCT02354599|FG004|Participant Flow|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223652|NCT02354599|FG005|Participant Flow|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223653|NCT02354599|OG000|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
10877323|NCT00446134|OG000|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877324|NCT00446134|OG001|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877325|NCT00446134|OG002|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877326|NCT00446134|OG003|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877327|NCT00446134|EG000|Reported Event|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877328|NCT00446134|EG001|Reported Event|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877329|NCT00446134|EG002|Reported Event|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877330|NCT00446134|EG003|Reported Event|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
10877331|NCT00446147|BG000|Baseline|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
10877332|NCT00446147|BG001|Baseline|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
10877333|NCT00446147|BG002|Baseline|Total|Total of all reporting groups
10877334|NCT00446147|FG000|Participant Flow|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
10877335|NCT00446147|FG001|Participant Flow|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
10877336|NCT00446147|OG000|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
10877337|NCT00446147|OG001|Outcome|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
10877338|NCT00446147|EG000|Reported Event|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
10877339|NCT00446147|EG001|Reported Event|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
10877340|NCT00446199|BG000|Baseline|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
10877341|NCT00446199|BG001|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
10877342|NCT00446199|BG002|Baseline|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
10877343|NCT00446199|BG003|Baseline|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
10877344|NCT00446199|BG004|Baseline|Total|Total of all reporting groups
10877345|NCT00446199|FG000|Participant Flow|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
10877346|NCT00446199|FG001|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
10877347|NCT00446199|FG002|Participant Flow|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
10877348|NCT00446199|FG003|Participant Flow|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
10877349|NCT00446199|OG000|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
10877350|NCT00446199|OG001|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
10877351|NCT00446199|OG002|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
10877352|NCT00446199|OG003|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
10877353|NCT00446199|EG000|Reported Event|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
10877354|NCT00446199|EG001|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
10877355|NCT00446199|EG002|Reported Event|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle)
10877356|NCT00446199|EG003|Reported Event|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
10877357|NCT00446251|BG000|Baseline|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
11223654|NCT02354599|OG001|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223655|NCT02354599|OG002|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223656|NCT02354599|OG003|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
10877358|NCT00446251|FG000|Participant Flow|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
10877359|NCT00446251|OG000|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
10877360|NCT00446251|EG000|Reported Event|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
10877361|NCT00446264|BG000|Baseline|Single Arm Group|Islet Allotransplantation Group
10877362|NCT00446264|FG000|Participant Flow|Single Arm Group|Islet Allotransplantation Group
10877363|NCT00446264|OG000|Outcome|Single Arm Group|Islet Allotransplantation Group
10877364|NCT00446264|EG000|Reported Event|Single Arm Group|Islet Allotransplantation Group
10877365|NCT00446290|BG000|Baseline|DXP Arm|Docetaxel, capecitabine and oxaliplatin
10877366|NCT00446290|FG000|Participant Flow|DXO Arm|"Docetaxel, capecitabine and oxaliplatin~Dose level Docetaxel(mg/m2) Capecitabine(mg/m2, twice daily) Oxaliplatin(mg/m2)~45 800 100~60 800 100~60 1,000 100~60 800 130~60 1,000 130"
10877367|NCT00446290|OG000|Outcome|DXO Arm|Docetaxel, capecitabine and oxaliplatin
10877368|NCT00446290|EG000|Reported Event|DXO Arm|Docetaxel, capecitabine and oxaliplatin
10877369|NCT00446446|BG000|Baseline|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
10877370|NCT00446446|FG000|Participant Flow|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
10877371|NCT00446446|OG000|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
10877372|NCT00446446|EG000|Reported Event|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
10877373|NCT00446459|BG000|Baseline|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
10877374|NCT00446459|FG000|Participant Flow|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
10877375|NCT00446459|OG000|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
10877376|NCT00446459|EG000|Reported Event|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
10877377|NCT00446511|BG000|Baseline|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877378|NCT00446511|BG001|Baseline|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877379|NCT00446511|BG002|Baseline|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877380|NCT00446511|BG003|Baseline|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877381|NCT00446511|BG004|Baseline|Total|Total of all reporting groups
10877382|NCT00446511|FG000|Participant Flow|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877383|NCT00446511|FG001|Participant Flow|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877384|NCT00446511|FG002|Participant Flow|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877385|NCT00446511|FG003|Participant Flow|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877386|NCT00446511|OG000|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877387|NCT00446511|OG001|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877388|NCT00446511|OG002|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877389|NCT00446511|OG003|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877390|NCT00446511|OG000|Outcome|Non-CKD Patients: Valsartan|All non-CKD patients assigned to valsartan in the core study (CVAL489K2302) continued their monotherapy treatment of valsartan 80/160/320 mg stratified by weight.
10877391|NCT00446511|OG001|Outcome|Non-CKD Patients: Enalapril|All non-CKD patients assigned to enalapril in the core study (CVAL489K2302) continued their monotherapy treatment of enalapril 10/20/40 mg stratified by weight.
10877392|NCT00446511|EG000|Reported Event|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877393|NCT00446511|EG001|Reported Event|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877394|NCT00446511|EG002|Reported Event|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877395|NCT00446511|EG003|Reported Event|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
10877396|NCT00446550|BG000|Baseline|Afegostat Tartrate Treatment Regimen 1|For the first 2 weeks, afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. After 2 weeks, participants then took 225 mg afegostat tartrate QD for 3 consecutive days, followed by no study medication for 4 consecutive days. This 3-days-on/4-days-off treatment regimen was followed for 22 weeks.
10877397|NCT00446550|BG001|Baseline|Afegostat Tartrate Treatment Regimen 2|Afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. This 7-days-on/7-days-off treatment regimen was followed for 24 weeks.
10877398|NCT00446550|BG002|Baseline|Total|Total of all reporting groups
10877399|NCT00446550|FG000|Participant Flow|Afegostat Tartrate Treatment Regimen 1|For the first 2 weeks, afegostat tartrate was administered orally at a dose of 225 milligrams (mg) once daily (QD) for 7 consecutive days, followed by no study medication for 7 consecutive days. After 2 weeks, participants then took 225 mg afegostat tartrate QD for 3 consecutive days, followed by no study medication for 4 consecutive days. This 3-days-on/4-days-off treatment regimen was followed for 22 weeks.
10877400|NCT00446550|FG001|Participant Flow|Afegostat Tartrate Treatment Regimen 2|Afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. This 7-days-on/7-days-off treatment regimen was followed for 24 weeks.
10877401|NCT00446550|OG000|Outcome|Afegostat Tartrate Treatment Regimen 1|For the first 2 weeks, afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. After 2 weeks, participants then took 225 mg afegostat tartrate QD for 3 consecutive days, followed by no study medication for 4 consecutive days. This 3-days-on/4-days-off treatment regimen was followed for 22 weeks.
10877402|NCT00446550|OG001|Outcome|Afegostat Tartrate Treatment Regimen 2|Afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days followed by no study medication for 7 consecutive days. This 7-days-on/7-days-off treatment regimen was followed for 24 weeks.
10877403|NCT00446550|OG001|Outcome|Afegostat Tartrate Treatment Regimen 2|Afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. This 7-days-on/7-days-off treatment regimen was followed for 24 weeks.
10877404|NCT00446550|EG000|Reported Event|Afegostat Tartrate Treatment Regimen 1|For the first 2 weeks, afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. After 2 weeks, participants then took 225 mg afegostat tartrate QD for 3 consecutive days, followed by no study medication for 4 consecutive days. This 3-days-on/4-days-off treatment regimen was followed for 22 weeks.
10877405|NCT00446550|EG001|Reported Event|Afegostat Tartrate Treatment Regimen 2|Afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. This 7-days-on/7-days-off treatment regimen was followed for 24 weeks.
10877406|NCT00446563|BG000|Baseline|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
10995759|NCT01029652|OG005|Outcome|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
10995760|NCT01029652|OG000|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
10995761|NCT01029652|EG000|Reported Event|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
10995762|NCT01029652|EG001|Reported Event|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
10995763|NCT01029652|EG002|Reported Event|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
10995764|NCT01029652|EG003|Reported Event|All Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
10995765|NCT01029652|EG004|Reported Event|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
10995766|NCT01029652|EG005|Reported Event|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
10995767|NCT01029691|BG000|Baseline|Compliant Autotitrating Positive Airway Pressure (APAP)|Women who used APAP for at least 4 hours/night
10995768|NCT01029691|BG001|Baseline|Non-compliant APAP|Women who did not use APAP for at least 4 hours/night
10995769|NCT01029691|BG002|Baseline|Standard Care|Non-APAP arm
10995770|NCT01029691|BG003|Baseline|Total|Total of all reporting groups
10995771|NCT01029691|FG000|Participant Flow|Compliant Users APAP|Women who used APAP at least 4 hours per night. Auto-titrating Positive Airway Pressure: Women will use APAP until delivery. Nocturnal blood pressure will be assessed at two time points: 1 week of APAP use and at regular intervals across pregnancy. Daytime blood pressure measurements across pregnancy will be obtained from medical records along with delivery information.
10995772|NCT01029691|FG001|Participant Flow|Non-Compliant APAP|Women who were in the APAP arm but who used less than 4 hours per night
10995773|NCT01029691|FG002|Participant Flow|Standard of Care|Women in the standard of care group will have clinical blood pressure measurements extracted from medical records. Delivery information will also be collected.
10995774|NCT01029691|OG000|Outcome|Positive Airway Pressure Adherent|Positive Airway Pressure: Women will use positive airway pressure until delivery
10995775|NCT01029691|OG001|Outcome|Positive Airway Pressure Non Adherent|Positive Airway Pressure: Women who used positive airway pressure for limited time
10995776|NCT01029691|OG002|Outcome|Standard Care|
10995777|NCT01029691|OG000|Outcome|Nocturnal Hypertension|Women with nocturnal hypertension (defined as blood pressure >117/68mmHg between 26-30 weeks and >123/72mmHg after 30 weeks)
10995778|NCT01029691|OG001|Outcome|No Nocturnal Hypertension|Women without nocturnal hypertension
10995779|NCT01029691|EG000|Reported Event|Positive Airway Pressure|Positive Airway Pressure: Women will use positive airway pressure until delivery
10995780|NCT01029691|EG001|Reported Event|Standard Care|
10995781|NCT01029704|BG000|Baseline|Segment 1 (Dose Escalation): EGT0001442 5mg|Received 5mg of EGT0001442 once daily for 28 days
10995782|NCT01029704|BG001|Baseline|Segment 1 (Dose Escalation): EGT0001442 10mg|Received 10mg of EGT0001442 once daily for 28 days
10995783|NCT01029704|BG002|Baseline|Segment 1 (Dose Escalation): EGT0001442 20mg|Received 20mg of EGT0001442 once daily for 28 days
10995784|NCT01029704|BG003|Baseline|Segment 1 (Dose Escalation): EGT0001442 50mg|Received 50mg of EGT0001442 once daily for 28 days
10995785|NCT01029704|BG004|Baseline|Segment 2 (Double-blind): Placebo|Received placebo once daily for 28 days
10995786|NCT01029704|BG005|Baseline|Segment 2 (Double-blind): EGT0001442 5mg|Received 5mg of EGT0001442 once daily for 28 days
10995787|NCT01029704|BG006|Baseline|Segment 2 (Double-blind): EGT0001442 10mg|Received 10mg of EGT0001442 once daily for 28 days
10995788|NCT01029704|BG007|Baseline|Segment 2 (Double-blind): EGT0001442 20mg|Received 20mg of EGT0001442 once daily for 28 days
10995789|NCT01029704|BG008|Baseline|Segment 2 (Double-blind): EGT0001442 50mg|Received 50mg of EGT0001442 once daily for 28 days
10995790|NCT01029704|BG009|Baseline|Total|Total of all reporting groups
10995791|NCT01029704|FG000|Participant Flow|Segment 1 (Dose Escalation): EGT0001442 5mg|Received 5mg of EGT0001442 once daily for 28 days
10995792|NCT01029704|FG001|Participant Flow|Segment 1 (Dose Escalation): EGT0001442 10mg|Received 10mg of EGT0001442 once daily for 28 days
10995793|NCT01029704|FG002|Participant Flow|Segment 1 (Dose Escalation): EGT0001442 20mg|Received 20mg of EGT0001442 once daily for 28 days
10995794|NCT01029704|FG003|Participant Flow|Segment 1 (Dose Escalation): EGT0001442 50mg|Received 50mg of EGT0001442 once daily for 28 days
10995795|NCT01029704|FG004|Participant Flow|Segment 2 (Double-blind): Placebo|Received placebo once daily for 28 days
10995796|NCT01029704|FG005|Participant Flow|Segment 2 (Double-blind): EGT0001442 5mg|Received 5mg of EGT0001442 once daily for 28 days
10995797|NCT01029704|FG006|Participant Flow|Segment 2 (Double-blind): EGT0001442 10mg|Received 10mg of EGT0001442 once daily for 28 days
10995798|NCT01029704|FG007|Participant Flow|Segment 2 (Double-blind): EGT0001442 20mg|Received 20mg of EGT0001442 once daily for 28 days
10995799|NCT01029704|FG008|Participant Flow|Segment 2 (Double-blind): EGT0001442 50mg|Received 50mg of EGT0001442 once daily for 28 days
10995800|NCT01029704|OG000|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
10995801|NCT01029704|OG001|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
10995802|NCT01029704|OG002|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
10995803|NCT01029704|OG003|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
10995804|NCT01029704|OG004|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
10995805|NCT01029704|OG000|Outcome|Segment 1 (Dose Escalation): EGT0001442 5mg|Received 5mg of EGT0001442 once daily for 28 days
10995806|NCT01029704|OG001|Outcome|Segment 1 (Dose Escalation): EGT0001442 10mg|Received 10mg of EGT0001442 once daily for 28 days
10995807|NCT01029704|OG002|Outcome|Segment 1 (Dose Escalation): EGT0001442 20mg|Received 20mg of EGT0001442 once daily for 28 days
10995808|NCT01029704|OG003|Outcome|Segment 1 (Dose Escalation): EGT0001442 50mg|Received 50mg of EGT0001442 once daily for 28 days
10995809|NCT01029704|EG000|Reported Event|Segment 1 (Dose Escalation): EGT0001442 5mg|Received 5mg of EGT0001442 once daily for 28 days
10995810|NCT01029704|EG001|Reported Event|Segment 1 (Dose Escalation): EGT0001442 10mg|Received 10mg of EGT0001442 once daily for 28 days
10995811|NCT01029704|EG002|Reported Event|Segment 1 (Dose Escalation): EGT0001442 20mg|Received 20mg of EGT0001442 once daily for 28 days
10995812|NCT01029704|EG003|Reported Event|Segment 1 (Dose Escalation): EGT0001442 50mg|Received 50mg of EGT0001442 once daily for 28 days
10995813|NCT01029704|EG004|Reported Event|Placebo|Received no drug (EGT0001442) during 28 days
10995814|NCT01029704|EG005|Reported Event|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
10995815|NCT01029704|EG006|Reported Event|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
10995816|NCT01029704|EG007|Reported Event|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
10995817|NCT01029704|EG008|Reported Event|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
10995818|NCT01029730|BG000|Baseline|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
10995819|NCT01029730|FG000|Participant Flow|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
10995820|NCT01029730|OG000|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
10995821|NCT01029730|EG000|Reported Event|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
10995822|NCT01029782|BG000|Baseline|IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin|IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.
10995823|NCT01029782|BG001|Baseline|Oral Cephalexin and Saline IV Plus Probenecid Placebo|Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
10995824|NCT01029782|BG002|Baseline|Total|Total of all reporting groups
10995825|NCT01029782|FG000|Participant Flow|IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin|IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.
10995826|NCT01029782|FG001|Participant Flow|Oral Cephalexin and Saline IV Plus Probenecid Placebo|Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
10877407|NCT00446563|BG001|Baseline|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
10877408|NCT00446563|BG002|Baseline|Total|Total of all reporting groups
10877409|NCT00446563|FG000|Participant Flow|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
10877410|NCT00446563|FG001|Participant Flow|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
10877411|NCT00446563|OG000|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
10877412|NCT00446563|OG001|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
10877413|NCT00446563|EG000|Reported Event|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
10877414|NCT00446563|EG001|Reported Event|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
10877415|NCT00446641|BG000|Baseline|Cilostazol|Cilostazol 100mg twice per day
10877416|NCT00446641|BG001|Baseline|Placebo|matching placebo to cilostazol
10877417|NCT00446641|BG002|Baseline|Total|Total of all reporting groups
10877418|NCT00446641|FG000|Participant Flow|Cilostazol|Cilostazol 100mg twice per day
10877419|NCT00446641|FG001|Participant Flow|Placebo|matching placebo to cilostazol
10877420|NCT00446641|OG000|Outcome|Cilostazol|Cilostazol 100mg twice per day
10877421|NCT00446641|OG001|Outcome|Placebo|matching placebo to cilostazol
10877422|NCT00446641|EG000|Reported Event|Cilostazol|Cilostazol 100mg twice per day
10877423|NCT00446641|EG001|Reported Event|Placebo|matching placebo to cilostazol
10877424|NCT00446654|BG000|Baseline|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
10877425|NCT00446654|BG001|Baseline|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
10877426|NCT00446654|BG002|Baseline|Total|Total of all reporting groups
10877427|NCT00446654|FG000|Participant Flow|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
10877428|NCT00446654|FG001|Participant Flow|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
10877429|NCT00446654|OG000|Outcome|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
10877430|NCT00446654|OG001|Outcome|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
10877431|NCT00446654|EG000|Reported Event|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
10877432|NCT00446654|EG001|Reported Event|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
10877433|NCT00446797|BG000|Baseline|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
10877434|NCT00446797|BG001|Baseline|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
10877435|NCT00446797|BG002|Baseline|Total|Total of all reporting groups
10877436|NCT00446797|FG000|Participant Flow|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
10877437|NCT00446797|FG001|Participant Flow|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
10877438|NCT00446797|OG000|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
10877439|NCT00446797|OG001|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
10877440|NCT00446797|EG000|Reported Event|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
10877441|NCT00446797|EG001|Reported Event|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
10877442|NCT00446849|BG000|Baseline|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase. A total of 208 subjects entered the maintenance phase (152 whose UC was quiescent at screening + 56 whose UC was quiescent after the acute phase).
10877443|NCT00446849|FG000|Participant Flow|Multi-Matrix System (MMX) Mesalamine|Subjects whose ulcerative colitis (UC) was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed orally once-daily [QD] at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
10877444|NCT00446849|OG000|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
10877445|NCT00446849|EG000|Reported Event|MMX Mesalamine (Acute Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day).
10877446|NCT00446849|EG001|Reported Event|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
10877447|NCT00446966|BG000|Baseline|Fish Oil|Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
10877448|NCT00446966|BG001|Baseline|Corn Oil|Standard grade corn oil
10877449|NCT00446966|BG002|Baseline|Total|Total of all reporting groups
10877450|NCT00446966|FG000|Participant Flow|Fish Oil|Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
10877451|NCT00446966|FG001|Participant Flow|Corn Oil|
10877452|NCT00446966|OG000|Outcome|Corn Oil|Corn oil
10877453|NCT00446966|OG001|Outcome|Fish Oil|
10877454|NCT00446966|EG000|Reported Event|Fish Oil|Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
10877455|NCT00446966|EG001|Reported Event|Corn Oil|Standard corn oil
10877456|NCT00446992|BG000|Baseline|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
10877457|NCT00446992|FG000|Participant Flow|Antipsychotic-Naive Patients|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
10877458|NCT00446992|OG000|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
10877459|NCT00446992|EG000|Reported Event|Open Follow Up Group|"The patients were newly diagnosed with psychosis and this is their first exposure to an antipsychotic.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
10877460|NCT00447005|BG000|Baseline|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
10877461|NCT00447005|FG000|Participant Flow|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
10877462|NCT00447005|OG000|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
10877463|NCT00447005|EG000|Reported Event|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
10877464|NCT00447057|BG000|Baseline|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
10877465|NCT00447057|BG001|Baseline|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
10877466|NCT00447057|BG002|Baseline|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
10877467|NCT00447057|BG003|Baseline|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity~Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
10877468|NCT00447057|BG004|Baseline|Total|Total of all reporting groups
10877469|NCT00447057|FG000|Participant Flow|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity
10877470|NCT00447057|FG001|Participant Flow|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle"
10877471|NCT00447057|FG002|Participant Flow|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
10877472|NCT00447057|FG003|Participant Flow|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
10877473|NCT00447057|OG000|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
10877474|NCT00447057|OG001|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
10877475|NCT00447057|OG000|Outcome|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
10877476|NCT00447057|OG001|Outcome|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
10877477|NCT00447057|EG000|Reported Event|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
10877478|NCT00447057|EG001|Reported Event|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
10877479|NCT00447083|BG000|Baseline|UVB First|"Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with UV. The dose of UV (time of exposure) will be progressively increased from 3 minutes to 9 minutes over the 6 visits to acclimate subjects to UV light. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive UVB tanning bed treatment first, then switch to the non-UVB treatment.~UVB: UVB exposure by a tanning bed"
10995827|NCT01029782|OG000|Outcome|IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin|IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.
10995828|NCT01029782|OG001|Outcome|Oral Cephalexin and Saline IV Plus Probenecid Placebo|Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
10995829|NCT01029782|EG000|Reported Event|IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin|IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.
10995830|NCT01029782|EG001|Reported Event|Oral Cephalexin and Saline IV Plus Probenecid Placebo|Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
10995831|NCT01029795|BG000|Baseline|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
10995832|NCT01029795|BG001|Baseline|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
10995833|NCT01029795|BG002|Baseline|Total|Total of all reporting groups
10995834|NCT01029795|FG000|Participant Flow|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
10995835|NCT01029795|FG001|Participant Flow|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
10995836|NCT01029795|OG000|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
10995837|NCT01029795|OG001|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
10995838|NCT01029795|EG000|Reported Event|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
10995839|NCT01029795|EG001|Reported Event|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
10995840|NCT01029886|BG000|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
10995841|NCT01029886|BG001|Baseline|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
10995842|NCT01029886|BG002|Baseline|Total|Total of all reporting groups
10995843|NCT01029886|FG000|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
10995844|NCT01029886|FG001|Participant Flow|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
10995845|NCT01029886|OG000|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
10995846|NCT01029886|OG001|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
10995847|NCT01029886|OG000|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection, 2mg, once weekly and with SU use at screening
10995848|NCT01029886|OG001|Outcome|Liraglutide Once Daily With SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and with SU use at screening
10995849|NCT01029886|OG002|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection, 2mg, once weekly and without SU use at screening
10995850|NCT01029886|OG003|Outcome|Liraglutide Once Daily Without SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and without SU use at screening
10995851|NCT01029886|EG000|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
10995852|NCT01029886|EG001|Reported Event|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
10995853|NCT01029912|BG000|Baseline|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
11223657|NCT02354599|OG004|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223658|NCT02354599|OG005|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223659|NCT02354599|OG000|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223660|NCT02354599|OG001|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223661|NCT02354599|OG002|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223662|NCT02354599|OG003|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
10995854|NCT01029912|BG001|Baseline|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
10995855|NCT01029912|BG002|Baseline|Total|Total of all reporting groups
10995856|NCT01029912|FG000|Participant Flow|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~CCFES Electrical Stimulator: 6-week intervention~Home: Self-administered active repetitive CCNMES-mediated ankle dorsiflexion exercise performed ten 51-minute sessions (three 15-min sets separated by 3-min rest) per week at home.~Lab: 15 minutes of therapist-guided CCFES-mediated ankle exercise + 30 minutes of gait training in the laboratory twice a week."
10995857|NCT01029912|FG001|Participant Flow|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Cyclic NMES Electrical Stimulator: 6-week intervention~Home: Self-administered active repetitive Cyclic NMES-mediated ankle dorsiflexion exercise performed ten 51-minute sessions (three 15-min sets separated by 3-min rest) per week at home.~Lab: 15 minutes of therapist-guided Cyclic NMES-mediated ankle exercise + 30 minutes of gait training in the laboratory twice a week."
10995858|NCT01029912|OG000|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
10995859|NCT01029912|OG001|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
10995860|NCT01029912|EG000|Reported Event|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
10995861|NCT01029912|EG001|Reported Event|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
10995862|NCT01029925|BG000|Baseline|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
10995863|NCT01029925|FG000|Participant Flow|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
10995864|NCT01029925|OG000|Outcome|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
10995865|NCT01029925|EG000|Reported Event|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
10995866|NCT01030133|BG000|Baseline|Real TMS|Participants in the real Transcranial Magnetic Stimulation (TMS) group will receive real stimulation across all interventions; the operator role and the receiver role. rTMS will be used to stimulate the left prefrontal cortex using two Neuronetics TMS machines with figure-8, iron core coils at 10Hz and at 110% of resting motor threshold [5 second trains following each trial (25 trials per visit)].
10995867|NCT01030133|BG001|Baseline|Sham TMS|Participants in the sham Transcranial Magnetic Stimulation (TMS) group will receive sham stimulation across all interventions; the operator role and the receiver role. Sham Stimulation involves 5 second trains of 10Hz rTMS in pairs alternating between real TMS and eSham TMS (randomly ordered). All sham treatment will be delivered with a specially designed, manufacture-provided sham TMS coil that looks and sounds identical to a real TMS coil but no magnetic current is transferred to the participant.
10995868|NCT01030133|BG002|Baseline|Total|Total of all reporting groups
10995869|NCT01030133|FG000|Participant Flow|Real TMS|Participants in the real Transcranial Magnetic Stimulation (TMS) group will receive real stimulation across all interventions; the operator role and the receiver role. rTMS will be used to stimulate the left prefrontal cortex using two Neuronetics TMS machines with figure-8, iron core coils at 10Hz and at 110% of resting motor threshold [5 second trains following each trial (25 trials per visit)].
10995870|NCT01030133|FG001|Participant Flow|Sham TMS|Participants in the sham Transcranial Magnetic Stimulation (TMS) group will receive sham stimulation across all interventions; the operator role and the receiver role. Sham Stimulation involves 5 second trains of 10Hz rTMS in pairs alternating between real TMS and eSham TMS (randomly ordered). All sham treatment will be delivered with a specially designed, manufacture-provided sham TMS coil that looks and sounds identical to a real TMS coil but no magnetic current is transferred to the participant.
10995871|NCT01030133|OG000|Outcome|Real TMS|Participants in the real Transcranial Magnetic Stimulation (TMS) group will receive real stimulation across all interventions; the operator role and the receiver role. rTMS will be used to stimulate the left prefrontal cortex using two Neuronetics TMS machines with figure-8, iron core coils at 10Hz and at 110% of resting motor threshold [5 second trains following each trial (25 trials per visit)].
11223663|NCT02354599|OG004|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223664|NCT02354599|OG005|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223665|NCT02354599|EG000|Reported Event|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223666|NCT02354599|EG001|Reported Event|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
10995872|NCT01030133|OG001|Outcome|Sham TMS|Participants in the sham Transcranial Magnetic Stimulation (TMS) group will receive sham stimulation across all interventions; the operator role and the receiver role. Sham Stimulation involves 5 second trains of 10Hz rTMS in pairs alternating between real TMS and eSham TMS (randomly ordered). All sham treatment will be delivered with a specially designed, manufacture-provided sham TMS coil that looks and sounds identical to a real TMS coil but no magnetic current is transferred to the participant.
10995873|NCT01030133|OG000|Outcome|Real TMS|Participants in the real Transcranial Magnetic Stimulation (TMS) group will receive real stimulation across all interventions; the operator role Real TMS and receiver role Real TMS. rTMS will be used to stimulate the left prefrontal cortex using two Neuronetics TMS machines with figure-8, iron core coils at 10Hz and at 110% of resting motor threshold [5 second trains following each trial (25 trials per visit)].
10995874|NCT01030133|OG001|Outcome|Sham TMS|Participants in the sham Transcranial Magnetic Stimulation (TMS) group will receive sham stimulation across all interventions; the operator role Sham TMS and receiver role Sham TMS. Sham Stimulation involves 5 second trains of 10Hz rTMS in pairs alternating between real TMS and eSham TMS (randomly ordered). All sham treatment will be delivered with a specially designed, manufacture-provided sham TMS coil that looks and sounds identical to a real TMS coil but no magnetic current is transferred to the participant.
10995875|NCT01030133|OG000|Outcome|Correct Guess|14 of 24 participants guessed the correct TMS condition
10995876|NCT01030133|OG001|Outcome|Incorrect Guess|10/24 participants incorrectly guessed their TMS condition
10995877|NCT01030133|EG000|Reported Event|Real TMS|Participants in the real Transcranial Magnetic Stimulation (TMS) group will receive real stimulation across all interventions; the operator role Real TMS and receiver role Real TMS. rTMS will be used to stimulate the left prefrontal cortex using two Neuronetics TMS machines with figure-8, iron core coils at 10Hz and at 110% of resting motor threshold [5 second trains following each trial (25 trials per visit)].
10995878|NCT01030133|EG001|Reported Event|Sham TMS|Participants in the sham Transcranial Magnetic Stimulation (TMS) group will receive sham stimulation across all interventions; the operator role Sham TMS and receiver role Sham TMS. Sham Stimulation involves 5 second trains of 10Hz rTMS in pairs alternating between real TMS and eSham TMS (randomly ordered). All sham treatment will be delivered with a specially designed, manufacture-provided sham TMS coil that looks and sounds identical to a real TMS coil but no magnetic current is transferred to the participant.
10995879|NCT01030289|BG000|Baseline|All Study Participants|All participants enrolled in the study
10995880|NCT01030289|FG000|Participant Flow|Real tDCS|"On the First Visit, A single 20-minute tDCS session will be conducted using 2.0mA current. Using the international 10-20 EEG system, the anode will be placed over F4, which corresponds to the right dorsolateral prefrontal cortex (DLPFC), and the cathode will be placed over F3, which corresponds to the left dorsolateral prefrontal cortex. Electrodes will be standard sponge electrodes soaked In a sterile solution of .9% sodium chloride insulated by a latex casing.~Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS."
10995881|NCT01030289|FG001|Participant Flow|Sham tDCS|"On the First Visit, For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.~Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS."
10995882|NCT01030289|OG000|Outcome|Real tDCS|"On the First Visit, A single 20-minute tDCS session will be conducted using 2.0mA current. Using the international 10-20 EEG system, the anode will be placed over F4, which corresponds to the right dorsolateral prefrontal cortex (DLPFC), and the cathode will be placed over F3, which corresponds to the left dorsolateral prefrontal cortex. Electrodes will be standard sponge electrodes soaked In a sterile solution of .9% sodium chloride insulated by a latex casing.~Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS."
10995883|NCT01030289|OG001|Outcome|Sham tDCS|"On the First Visit, For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.~Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS."
10995884|NCT01030289|OG000|Outcome|All Subjects|All 19 Participants
10995885|NCT01030289|EG000|Reported Event|Real tDCS|transcranial direct current stimulation: transcranial direct current stimulation
10995886|NCT01030289|EG001|Reported Event|Sham tDCS|transcranial direct current stimulation: transcranial direct current stimulation
10995887|NCT01030406|BG000|Baseline|40/0mg Taken First|oxycodone.naicin 40/0mg tablets
10995888|NCT01030406|BG001|Baseline|80/0mg Taken First|oxycodone.naicin 80/0mg tablets
10995889|NCT01030406|BG002|Baseline|40/240mg Taken First|oxycodone.naicin 40/240mg tablets
10995890|NCT01030406|BG003|Baseline|80/480mg Taken First|oxycodone.naicin 80/480mg tablets
10995891|NCT01030406|BG004|Baseline|0/0mg Taken First|Placebo Tablets
10995892|NCT01030406|BG005|Baseline|Total|Total of all reporting groups
10995893|NCT01030406|FG000|Participant Flow|40/0mg Taken First|Ocycodone/Naicin 40/0mg Tablets
10995894|NCT01030406|FG001|Participant Flow|80/0mg Taken First|Oxycodone/Niacin 80/0mg tablets
10995895|NCT01030406|FG002|Participant Flow|40/240mg Taken First|Oxycodone?Niacin 40/240mg tablets
10995896|NCT01030406|FG003|Participant Flow|80/480mg Taken First|Oxycodone/Naicin 80/480mg
10995897|NCT01030406|FG004|Participant Flow|0/0mg Taken First|Placebo: Tablets
10995898|NCT01030406|OG000|Outcome|40/0mg|8x Oxycodone/Naicin 5/0mg tablets
10995899|NCT01030406|OG001|Outcome|80/0mg|8x Oxycodone/Naicin 10/0mg tablets
10995900|NCT01030406|OG002|Outcome|40/240mg|8x Oxycodone/Naicin 5/30mg tablets
10995901|NCT01030406|OG003|Outcome|80/480mg|8x Oxycodone/Naicin 10/60mg tablets
10995902|NCT01030406|OG004|Outcome|0/0mg|Placebo: Tablets
10995903|NCT01030406|EG000|Reported Event|40/0mg|Oxycodone hcl 40mg
10995904|NCT01030406|EG001|Reported Event|80/0mg|Oxycodone hcl 40mg
10995905|NCT01030406|EG002|Reported Event|40/240mg|Oxycodone hcl 40mg/niacin 240mg
10995906|NCT01030406|EG003|Reported Event|80/480ng|Oxycodone hcl 80mg/niacin 480mg
10995907|NCT01030406|EG004|Reported Event|0/0mg|Placebo: Tablets
10877480|NCT00447083|BG001|Baseline|Non-UVB First|"Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with non-UV bulbs. The time of exposure will be progressively increased from 3 minutes to 9 minutes over the 6 visits to mirror UVB treatment. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive non-UVB tanning bed treatment first, then switch to the UVB treatment.~UVB: UVB exposure by a tanning bed"
10877481|NCT00447083|BG002|Baseline|Total|Total of all reporting groups
10877482|NCT00447083|FG000|Participant Flow|Phase I - UVB First|"Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with UV. The dose of UV (time of exposure) will be progressively increased from 3 minutes to 9 minutes over the 6 visits to acclimate subjects to UV light. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive UVB tanning bed treatment first, then switch to the non-UVB treatment.~UVB: UVB exposure by a tanning bed"
10877483|NCT00447083|FG001|Participant Flow|Phase I - Non-UVB First|"Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with non-UV bulbs. The time of exposure will be progressively increased from 3 minutes to 9 minutes over the 6 visits to mirror UVB treatment. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive non-UVB tanning bed treatment first, then switch to the UVB treatment.~UVB: UVB exposure by a tanning bed"
10877484|NCT00447083|FG002|Participant Flow|Phase II - UVB Exposure|Part of the subjects who complete the acclimation phase of the study ( Phase I) will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of UVB.
10877485|NCT00447083|FG003|Participant Flow|Phase II -Non-UVB|Part of the subjects who complete the acclimation phase of the study ( Phase I) will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of non-UVB exposure in Phase II.
10877486|NCT00447083|OG000|Outcome|UVB Exposure|"Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with UV. The dose of UV (time of exposure) will be progressively increased from 3 minutes to 9 minutes over the 6 visits to acclimate subjects to UV light. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group received UVB tanning bed treatment.~UVB: UVB exposure by a tanning bed"
10877487|NCT00447083|OG001|Outcome|Non-UVB Exposure|"Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with non-UV bulbs. The time of exposure will be progressively increased from 3 minutes to 9 minutes over the 6 visits to mirror UVB treatment. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group received non-UVB tanning bed treatment.~UVB: UVB exposure by a tanning bed"
10877488|NCT00447083|OG000|Outcome|UVB Exposure|The subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of UVB.
10877489|NCT00447083|OG001|Outcome|Non-UVB|The subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of non-UVB exposure
10877490|NCT00447083|EG000|Reported Event|UVB Exposure|The subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of UVB.
10877491|NCT00447083|EG001|Reported Event|Non-UVB|The subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of non-UVB exposure
10877492|NCT00447226|BG000|Baseline|All Participants|All participants treated in the open-label phase (1500 milligrams [mg] lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
10877493|NCT00447226|FG000|Participant Flow|Placebo|Identical matching placebo orally, once a day
10877494|NCT00447226|FG001|Participant Flow|Lapatinib 1500 Milligrams (mg)|Lapatinib 1500 mg orally, once a day
10877495|NCT00447226|OG000|Outcome|Open-label Lapatinib 1500 Milligrams (mg)|Open-label lapatinib 1500 mg orally, once a day
10877496|NCT00447226|OG000|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
10877497|NCT00447226|OG001|Outcome|Placebo|Identical matching placebo orally, once a day
10877498|NCT00447226|OG000|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
10877499|NCT00447226|OG001|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
10877500|NCT00447226|OG002|Outcome|Placebo|Identical matching placebo orally, once a day
10877501|NCT00447226|OG000|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day: up to end of Stage 1
10877502|NCT00447226|OG001|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day: up to end of Stage 2
10877503|NCT00447226|OG002|Outcome|Placebo|Identical matching placebo orally, once a day: up to end of Stage 2
10877504|NCT00447226|OG000|Outcome|All Participants With Ovarian Cancer|All participants with ovarian cancer treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
10877505|NCT00447226|OG000|Outcome|Screened Participants With Gastric Cancer|Screened participants with gastric cancer
10877506|NCT00447226|OG000|Outcome|All Screened Participants|All screened participants
10877507|NCT00447226|EG000|Reported Event|All Participants|All participants treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
10877508|NCT00447265|BG000|Baseline|Etanercept|Participant self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks. She continued receiving her usual treatment with corticosteroids and mycophenolate mofetil.
10877509|NCT00447265|FG000|Participant Flow|Etanercept|Participants (or their caretaker) would administer 50 mg etanercept subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
10877510|NCT00447265|FG001|Participant Flow|Placebo|Participants (or their caretaker) would administer 50 mg placebo subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
10877511|NCT00447265|OG000|Outcome|Etanercept|Etanercept plus standard of care
10877512|NCT00447265|EG000|Reported Event|Etanercept|Participant received self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks while continuing to receive her usual lupus treatment of corticosteroids and mycophenolate mofetil.
10877513|NCT00447278|BG000|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
10877514|NCT00447278|BG001|Baseline|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
10877515|NCT00447278|BG002|Baseline|Total|Total of all reporting groups
10877516|NCT00447278|FG000|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
10877517|NCT00447278|FG001|Participant Flow|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
10877518|NCT00447278|OG000|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
10877519|NCT00447278|OG001|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
10877520|NCT00447278|OG000|Outcome|Pearson Correlation Coefficient|Correlation Coefficient between parent-rated and patient-rated CHIP T-score domains.
10877521|NCT00447278|EG000|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
10877522|NCT00447278|EG001|Reported Event|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
10877523|NCT00447330|BG000|Baseline|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
10877524|NCT00447330|FG000|Participant Flow|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
10877525|NCT00447330|OG000|Outcome|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
10877526|NCT00447330|OG000|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
10877527|NCT00447330|EG000|Reported Event|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
10877528|NCT00447382|BG000|Baseline|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
10877529|NCT00447382|BG001|Baseline|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
10877530|NCT00447382|BG002|Baseline|Total|Total of all reporting groups
10877531|NCT00447382|FG000|Participant Flow|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
10877532|NCT00447382|FG001|Participant Flow|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
10877533|NCT00447382|OG000|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
10995908|NCT01030458|BG000|Baseline|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
10995909|NCT01030458|BG001|Baseline|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
10995910|NCT01030458|BG002|Baseline|Total|Total of all reporting groups
10995911|NCT01030458|FG000|Participant Flow|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
10995912|NCT01030458|FG001|Participant Flow|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
10995913|NCT01030458|OG000|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
10995914|NCT01030458|OG001|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
10995915|NCT01030458|EG000|Reported Event|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
10995916|NCT01030458|EG001|Reported Event|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
10995917|NCT01030523|BG000|Baseline|Short Implants|ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
10995918|NCT01030523|BG001|Baseline|Long Implants|ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
10995919|NCT01030523|BG002|Baseline|Total|Total of all reporting groups
10995920|NCT01030523|FG000|Participant Flow|Short Implants|ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
10995921|NCT01030523|FG001|Participant Flow|Long Implants|ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
10995922|NCT01030523|OG000|Outcome|Short Implants|ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
10995923|NCT01030523|OG001|Outcome|Long Implants|ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
10995924|NCT01030523|EG000|Reported Event|Short Implants|ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
10995925|NCT01030523|EG001|Reported Event|Long Implants|ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
10995926|NCT01030536|BG000|Baseline|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995927|NCT01030536|BG001|Baseline|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995928|NCT01030536|BG002|Baseline|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995929|NCT01030536|BG003|Baseline|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995930|NCT01030536|BG004|Baseline|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995931|NCT01030536|BG005|Baseline|Total|Total of all reporting groups
10995932|NCT01030536|FG000|Participant Flow|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995933|NCT01030536|FG001|Participant Flow|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995934|NCT01030536|FG002|Participant Flow|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995935|NCT01030536|FG003|Participant Flow|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995936|NCT01030536|FG004|Participant Flow|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995937|NCT01030536|OG000|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995938|NCT01030536|OG001|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995939|NCT01030536|OG002|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995940|NCT01030536|OG003|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995941|NCT01030536|OG004|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995942|NCT01030536|OG000|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
10995943|NCT01030536|OG001|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
10995944|NCT01030536|OG002|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
10995945|NCT01030536|OG003|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
10995946|NCT01030536|EG000|Reported Event|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995947|NCT01030536|EG001|Reported Event|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995948|NCT01030536|EG002|Reported Event|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
11007569|NCT01091428|EG002|Reported Event|Alisertib 40 mg BID+ Paclitaxel 60 mg/m^2 (Phase 2)|Alisertib 40 mg, orally, BID on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2 (Up to 28 cycles).
10995949|NCT01030536|EG003|Reported Event|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995950|NCT01030536|EG004|Reported Event|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
10995951|NCT01030653|BG000|Baseline|Voriconazole High Dose First Then Low Dose|Both voriconazole arms are shown as a single group because the same individuals received both arms of the intervention in a cross-over design.
10995952|NCT01030653|BG001|Baseline|Voriconazole Low Dose First Then High Dose|
10995953|NCT01030653|BG002|Baseline|Total|Total of all reporting groups
10995954|NCT01030653|FG000|Participant Flow|Voriconazole High Dose First Then Low Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses)
10995955|NCT01030653|FG001|Participant Flow|Voriconazole Low Dose First Then High Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses)
10995956|NCT01030653|OG000|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
10995957|NCT01030653|OG001|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
10995958|NCT01030653|OG000|Outcome|Voriconazole High : Low Dose|"Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)~Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)"
10995959|NCT01030653|EG000|Reported Event|Voriconazole High Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
10995960|NCT01030653|EG001|Reported Event|Voriconazole Low Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
10995961|NCT01030666|BG000|Baseline|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
10995962|NCT01030666|BG001|Baseline|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
10995963|NCT01030666|BG002|Baseline|Total|Total of all reporting groups
10995964|NCT01030666|FG000|Participant Flow|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
10995965|NCT01030666|FG001|Participant Flow|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
10995966|NCT01030666|OG000|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects addionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
10995967|NCT01030666|OG001|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
10995968|NCT01030666|OG000|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
10995969|NCT01030666|EG000|Reported Event|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
10995970|NCT01030666|EG001|Reported Event|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
10995971|NCT01030718|BG000|Baseline|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995972|NCT01030718|BG001|Baseline|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
11007570|NCT01091428|EG003|Reported Event|Paclitaxel 80 mg/m^2 (Phase 2)|Paclitaxel 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 2 (Up to 28 cycles).
10995973|NCT01030718|BG002|Baseline|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995974|NCT01030718|BG003|Baseline|Total|Total of all reporting groups
10995975|NCT01030718|FG000|Participant Flow|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995976|NCT01030718|FG001|Participant Flow|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995977|NCT01030718|FG002|Participant Flow|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Philadelphia chromosome positive (Ph+) ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995978|NCT01030718|OG000|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995979|NCT01030718|OG001|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995980|NCT01030718|OG002|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995981|NCT01030718|OG000|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995982|NCT01030718|OG001|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995983|NCT01030718|OG002|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995984|NCT01030718|OG000|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995985|NCT01030718|OG001|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995986|NCT01030718|OG002|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995987|NCT01030718|OG000|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995988|NCT01030718|OG001|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
11007571|NCT01091454|BG000|Baseline|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10995989|NCT01030718|OG002|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995990|NCT01030718|OG000|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995991|NCT01030718|OG000|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995992|NCT01030718|OG001|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995993|NCT01030718|EG000|Reported Event|All Treated Participants|Imatinib resistant or intolerant CML-CP disease cohort, Imatinib resistant or intolerant CML-AP/BP disease cohort, and Ph+ ALL subjects with resistance or intolerance to past therapy. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
10995994|NCT01030783|BG000|Baseline|Tivozanib (AV-951)|tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
10995995|NCT01030783|BG001|Baseline|Sorafenib|Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
10995996|NCT01030783|BG002|Baseline|Total|Total of all reporting groups
10995997|NCT01030783|FG000|Participant Flow|Tivozanib (AV-951)|tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
10995998|NCT01030783|FG001|Participant Flow|Sorafenib|Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
10995999|NCT01030783|OG000|Outcome|Tivozanib (AV-951)|tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
10996000|NCT01030783|OG001|Outcome|Sorafenib|Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
10996001|NCT01030783|EG000|Reported Event|Tivozanib (AV-951)|tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
10996002|NCT01030783|EG001|Reported Event|Sorafenib|Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
10996003|NCT01030822|BG000|Baseline|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
10996004|NCT01030822|BG001|Baseline|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
10996005|NCT01030822|BG002|Baseline|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
10996006|NCT01030822|BG003|Baseline|Total|Total of all reporting groups
10996007|NCT01030822|FG000|Participant Flow|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
10996008|NCT01030822|FG001|Participant Flow|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
11007572|NCT01091454|FG000|Participant Flow|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10996009|NCT01030822|FG002|Participant Flow|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
10996010|NCT01030822|OG000|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
10996011|NCT01030822|OG001|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
10996012|NCT01030822|OG000|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
10996013|NCT01030822|OG002|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
10996014|NCT01030822|EG000|Reported Event|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
10996015|NCT01030822|EG001|Reported Event|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
10996016|NCT01030822|EG002|Reported Event|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
10996017|NCT01030861|BG000|Baseline|Teplizumab|"Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.~Teplizumab: intravenous infusions"
10996018|NCT01030861|BG001|Baseline|Placebo Infusion|"Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.~Placebo infusion: Placebo for Teplizumab"
10996019|NCT01030861|BG002|Baseline|Total|Total of all reporting groups
10996020|NCT01030861|FG000|Participant Flow|Teplizumab|"Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.~Teplizumab: intravenous infusions"
10996021|NCT01030861|FG001|Participant Flow|Placebo Infusion|"Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.~Placebo infusion: Placebo for Teplizumab"
10996022|NCT01030861|OG000|Outcome|Teplizumab|"Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.~Teplizumab: intravenous infusions"
10996023|NCT01030861|OG001|Outcome|Placebo Infusion|"Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.~Placebo infusion: Placebo for Teplizumab"
10996024|NCT01030861|EG000|Reported Event|Teplizumab|"Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.~Teplizumab: intravenous infusions"
10996025|NCT01030861|EG001|Reported Event|Placebo Infusion|"Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.~Placebo infusion: Placebo for Teplizumab"
11007573|NCT01091454|OG000|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11007574|NCT01091454|EG000|Reported Event|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11007575|NCT01091519|BG000|Baseline|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
11007576|NCT01091519|BG001|Baseline|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
11007577|NCT01091519|BG002|Baseline|Total|Total of all reporting groups
10996026|NCT01030874|BG000|Baseline|Arm 1|Usual rehab care
10996027|NCT01030874|BG001|Baseline|Arm 2|"Treatment for, and prevention of, orthostatic hypotension~Medications will be reviewed to identify those with potentially hypotensive actions. After joint review by Provider, Pharmacist, and Research staff, a plan to continue, decrease, discontinue, or substitute will be made. Examples include substitution of tamsulosin for prazosin in treating benign prostatic hypertrophy, reduction of furosemide dose for patient with stable congestive heart failure, change of sleeping medication from trazodone to lorazepam or zolpidem; change of antidepressant therapy or neuroleptic therapy to one with less hypotensive effects.(Mader 1989); (Poon and Braun 2005);(Mader 2006); (2008).~Nutrition/Salt intake: Current diet orders and meal consumption will be reviewed for sodium and fluid intake. Liberalization of calories, fluid, addition of salt packets to t"
10996028|NCT01030874|BG002|Baseline|Total|Total of all reporting groups
10996029|NCT01030874|FG000|Participant Flow|Arm 1/ Inpatient Rehabilitation Care (Usual Care)|Usual rehab care
10996030|NCT01030874|FG001|Participant Flow|Arm 2 / Treatment for, and Prevention of, Orthostatic Hypotension.|Orthostatic hypotension interventions
10996031|NCT01030874|OG000|Outcome|Arm 1|Usual rehab care
10996032|NCT01030874|OG001|Outcome|Arm 2|"Treatment for, and prevention of, orthostatic hypotension~Medication review: Current scheduled and as needed medications will be reviewed. Those medications with potentially hypotensive actions will be identified. There will be a joint review by Provider, Pharmacist, and Research staff of those medications and the patient's current clinical status. Plan to continue, decrease, discontinue, or substitute will be made. Examples include substitution of tamsulosin for prazosin in treating benign prostatic hypertrophy, reduction of furosemide dose for patient with stable congestive heart failure, change of sleeping medication from trazodone to lorazepam or zolpidem; change of antidepressant therapy or neuroleptic therapy to one with less hypotensive effects.(Mader 1989); (Poon and Braun 2005);(Mader 2006); (2008).~Nutrition/Salt intake: Current diet orders and meal consumption will be reviewed for sodium and fluid intake. Liberalization of calories, fluid, addition of salt packets to t"
10996033|NCT01030874|EG000|Reported Event|Arm 1|Usual rehab care
10996034|NCT01030874|EG001|Reported Event|Arm 2|"Treatment for, and prevention of, orthostatic hypotension~Medications will be reviewed to identify those with potentially hypotensive actions. After joint review by Provider, Pharmacist, and Research staff, a plan to continue, decrease, discontinue, or substitute will be made. Examples include substitution of tamsulosin for prazosin in treating benign prostatic hypertrophy, reduction of furosemide dose for patient with stable congestive heart failure, change of sleeping medication from trazodone to lorazepam or zolpidem; change of antidepressant therapy or neuroleptic therapy to one with less hypotensive effects.(Mader 1989); (Poon and Braun 2005);(Mader 2006); (2008).~Nutrition/Salt intake: Current diet orders and meal consumption will be reviewed for sodium and fluid intake. Liberalization of calories, fluid, addition of salt packets to t"
10996035|NCT01030952|BG000|Baseline|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
10996036|NCT01030952|BG001|Baseline|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
10996037|NCT01030952|BG002|Baseline|Total|Total of all reporting groups
10996038|NCT01030952|FG000|Participant Flow|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
10996039|NCT01030952|FG001|Participant Flow|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
10996040|NCT01030952|OG000|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
10996041|NCT01030952|OG001|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
10996042|NCT01030952|OG000|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
10996043|NCT01030952|OG001|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
10996044|NCT01030952|EG000|Reported Event|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
10996045|NCT01030952|EG001|Reported Event|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
10996046|NCT01030965|BG000|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
10996047|NCT01030965|BG001|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
10996048|NCT01030965|BG002|Baseline|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
10996049|NCT01030965|BG003|Baseline|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
10996050|NCT01030965|BG004|Baseline|Total|Total of all reporting groups
10996051|NCT01030965|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
10996052|NCT01030965|FG001|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
10996053|NCT01030965|FG002|Participant Flow|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
10996054|NCT01030965|FG003|Participant Flow|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
10996055|NCT01030965|OG000|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
10996056|NCT01030965|OG001|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
10996057|NCT01030965|OG002|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
10996058|NCT01030965|OG003|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
10996059|NCT01030965|EG000|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
10996060|NCT01030965|EG001|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
10996061|NCT01030965|EG002|Reported Event|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
10996062|NCT01030965|EG003|Reported Event|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
10996063|NCT01031004|BG000|Baseline|Narafilcon B|single use, daily wear contact lens
10996064|NCT01031004|BG001|Baseline|Etafilcon A|contact lens worn as single use, daily wear
10996065|NCT01031004|BG002|Baseline|Total|Total of all reporting groups
10996066|NCT01031004|FG000|Participant Flow|Narafilcon B|single use, daily wear contact lens
10996067|NCT01031004|FG001|Participant Flow|Etafilcon A|contact lens worn as single use, daily wear
10996068|NCT01031004|OG000|Outcome|Narafilcon B|single use, daily wear contact lens
10996069|NCT01031004|OG001|Outcome|Etafilcon A|contact lens worn as single use, daily wear
10996070|NCT01031004|EG000|Reported Event|Narafilcon B|single use, daily wear contact lens
10996071|NCT01031004|EG001|Reported Event|Etafilcon A|contact lens worn as single use, daily wear
10996072|NCT01031043|BG000|Baseline|Topical Bethanechol|patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
10996073|NCT01031043|FG000|Participant Flow|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
10996074|NCT01031043|OG000|Outcome|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
10996075|NCT01031043|EG000|Reported Event|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
10996076|NCT01031069|BG000|Baseline|HIV+/Cervarix Group|HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996077|NCT01031069|BG001|Baseline|HIV+/Gardasil Group|HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996078|NCT01031069|BG002|Baseline|HIV-/Cervarix Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996079|NCT01031069|BG003|Baseline|HIV-/Gardasil Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996080|NCT01031069|BG004|Baseline|Total|Total of all reporting groups
10996081|NCT01031069|FG000|Participant Flow|HIV+/Cervarix Group|HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996082|NCT01031069|FG001|Participant Flow|HIV+/Gardasil Group|HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996083|NCT01031069|FG002|Participant Flow|HIV-/Cervarix Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996084|NCT01031069|FG003|Participant Flow|HIV-/Gardasil Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996085|NCT01031069|OG000|Outcome|HIV+/Cervarix Group|HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996086|NCT01031069|OG001|Outcome|HIV+/Gardasil Group|HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
11223667|NCT02354599|EG002|Reported Event|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11223668|NCT02354599|EG003|Reported Event|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
10996087|NCT01031069|OG000|Outcome|HIV-/Cervarix Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996088|NCT01031069|OG001|Outcome|HIV-/Gardasil Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996089|NCT01031069|OG002|Outcome|HIV-/Cervarix Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996090|NCT01031069|OG003|Outcome|HIV-/Gardasil Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996091|NCT01031069|EG000|Reported Event|HIV+/Cervarix Group|HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996092|NCT01031069|EG001|Reported Event|HIV+/Gardasil Group|HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996093|NCT01031069|EG002|Reported Event|HIV-/Cervarix Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996094|NCT01031069|EG003|Reported Event|HIV-/Gardasil Group|HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
10996095|NCT01031095|BG000|Baseline|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
10996096|NCT01031095|BG001|Baseline|Standard Therapy|standard UFH treatment
10996097|NCT01031095|BG002|Baseline|Total|Total of all reporting groups
10996098|NCT01031095|FG000|Participant Flow|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
10996099|NCT01031095|FG001|Participant Flow|Standard Therapy|standard unfractionated heparin (UFH) treatment
10996100|NCT01031095|OG000|Outcome|Standard Therapy|standard UFH treatment (intravenous standard dose unfractioned heparin group)
10996101|NCT01031095|OG000|Outcome|Low Dose Intracoronary Heparin Treatment Arm|low dose intracoronary heparin treatment arm (intracoronary 1000 IU unfractioned heparin arm)
11348276|NCT04194008|FG000|Participant Flow|Nerivio Device Treatment|"Treatment with active Nerivio device~Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
10846564|NCT00278148|BG000|Baseline|Erlotinib, Paclitaxel, and Carboplatin With Radiation|"All participants that went on study at the three dose levels.~Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin"
10846565|NCT00278148|FG000|Participant Flow|Dose Level A|Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
10846566|NCT00278148|FG001|Participant Flow|Dose Level B|Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
10996102|NCT01031095|EG000|Reported Event|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
10996103|NCT01031095|EG001|Reported Event|Standard Therapy|standard UFH treatment
10996104|NCT01031134|BG000|Baseline|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
10996105|NCT01031134|BG001|Baseline|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
10996106|NCT01031134|BG002|Baseline|Total|Total of all reporting groups
10996107|NCT01031134|FG000|Participant Flow|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
10996108|NCT01031134|FG001|Participant Flow|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
10996109|NCT01031134|OG000|Outcome|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
10996110|NCT01031134|OG001|Outcome|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
10996111|NCT01031134|EG000|Reported Event|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
10996112|NCT01031134|EG001|Reported Event|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
10996113|NCT01031381|BG000|Baseline|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
10996114|NCT01031381|FG000|Participant Flow|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
10996115|NCT01031381|OG000|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously.
10996116|NCT01031381|OG000|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
10996117|NCT01031381|EG000|Reported Event|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
10846567|NCT00278148|FG002|Participant Flow|Dose Level C|Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
10996118|NCT01031420|BG000|Baseline|Dose Dense MVAC|"standard doses of MVAC given every 14 days x 3.~single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days."
10996119|NCT01031420|FG000|Participant Flow|Dose Dense MVAC|"standard doses of MVAC given every 14 days x 3.~single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days."
10996120|NCT01031420|OG000|Outcome|Dose Dense MVAC|"standard doses of MVAC given every 14 days x 3.~single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days."
10996121|NCT01031420|EG000|Reported Event|Dose Dense MVAC|"standard doses of MVAC given every 14 days x 3.~single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days."
10996122|NCT01031446|BG000|Baseline|RAD001 Cisplatin Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
10996123|NCT01031446|FG000|Participant Flow|RAD001 and Cisplatin and Pacletaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks. All patients began at the same dose level of the study drugs with no de-escalation of dose, thus results for Phase I and II were combined
10996124|NCT01031446|OG000|Outcome|RAD001 and Cisplatin and Paclitazel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
10996125|NCT01031446|OG000|Outcome|RAD001 and Cisplatin and Paclitaxel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
10996126|NCT01031446|OG000|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
10996127|NCT01031446|EG000|Reported Event|RAD001 and Cisplatin and Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
10996128|NCT01031498|BG000|Baseline|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
10996129|NCT01031498|BG001|Baseline|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
10996130|NCT01031498|BG002|Baseline|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
10996131|NCT01031498|BG003|Baseline|Total|Total of all reporting groups
10996132|NCT01031498|FG000|Participant Flow|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
10996133|NCT01031498|FG001|Participant Flow|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
10996134|NCT01031498|FG002|Participant Flow|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
10996135|NCT01031498|OG000|Outcome|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
10996136|NCT01031498|OG001|Outcome|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
10996137|NCT01031498|OG002|Outcome|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
10996138|NCT01031498|EG000|Reported Event|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
10996139|NCT01031498|EG001|Reported Event|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
10996140|NCT01031498|EG002|Reported Event|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
10996141|NCT01031537|BG000|Baseline|FSME-IMMUN 0.5mL Baxter|"FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants received active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that tested seropositive for tick-borne encephalitis or subjects that developed positive viral neutralizer titers after the 3rd or 4th vaccine were given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.~FSME-IMMUN 0.5ml Baxter: Vaccine"
10996142|NCT01031537|FG000|Participant Flow|FSME-IMMUN 0.5mL Baxter|"FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants will receive active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that test seropositive for tick-borne encephalitis or subjects that develop positive viral neutralizer titers after the 3rd or 4th vaccine will be given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.~FSME-IMMUN 0.5ml Baxter: Vaccine"
10996143|NCT01031537|OG000|Outcome|FSME-IMMUN 0.5mL Baxter|"FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants received active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that tested seropositive for tick-borne encephalitis or subjects that developed positive viral neutralizer titers after the 3rd or 4th vaccine were given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.~FSME-IMMUN 0.5ml Baxter: Vaccine"
10996144|NCT01031537|EG000|Reported Event|FSME-IMMUN 0.5mL Baxter|"FSME-IMMUN 0.5mL Baxter is non-US licensed vaccine for tick-borne encephalitis. The FSME-IMMUN 0.5mL Baxter is available as 0.5mL in a pre-loaded vaccine syringe. All participants will receive active vaccine using a rapid immunization schedule, with vaccine administration on Days 0, 14, 161 and 245. Participants that test seropositive for tick-borne encephalitis or subjects that develop positive viral neutralizer titers after the 3rd or 4th vaccine will be given a booster of FSME-IMMUN 0.5mL Baxter vaccine at 3, 6 and 9 years after enrollment.~FSME-IMMUN 0.5ml Baxter: Vaccine"
10996145|NCT01031680|BG000|Baseline|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
10996146|NCT01031680|BG001|Baseline|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
10996147|NCT01031680|BG002|Baseline|Total|Total of all reporting groups
10996148|NCT01031680|FG000|Participant Flow|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
10996149|NCT01031680|FG001|Participant Flow|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
10996150|NCT01031680|OG000|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
10996151|NCT01031680|OG001|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
10996152|NCT01031680|EG000|Reported Event|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
10996153|NCT01031680|EG001|Reported Event|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
10996154|NCT01031706|BG000|Baseline|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
10996155|NCT01031706|BG001|Baseline|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
10996156|NCT01031706|BG002|Baseline|Total|Total of all reporting groups
10996157|NCT01031706|FG000|Participant Flow|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
10996158|NCT01031706|FG001|Participant Flow|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
10996159|NCT01031706|OG000|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
10996160|NCT01031706|OG001|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
10996161|NCT01031706|EG000|Reported Event|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
10996162|NCT01031706|EG001|Reported Event|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
10996163|NCT01031810|BG000|Baseline|Tranylcypromine|patients will receive treatment with tranylcypromine
10996164|NCT01031810|FG000|Participant Flow|Tranylcypromine|Patients will receive treatment with tranylcypromine tablets taken orally on a twice daily schedule. Dosage was initially 10 mg daily and was increased weekly up to 120 mg daily.
10996165|NCT01031810|OG000|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
10996166|NCT01031810|OG000|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: monoamine oxidase inhibitor (MAOI) 60mg-120mg"
10996167|NCT01031810|OG000|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
10996168|NCT01031810|EG000|Reported Event|Tranylcypromine|patients will receive treatment with tranylcypromine
10996169|NCT01031836|BG000|Baseline|MEDI-545 1.0 mg/kg IV|MEDI-545 1.0 mg/kg IV once every 2 weeks
10996170|NCT01031836|BG001|Baseline|MEDI-545 3.0 mg/kg IV|MEDI-545 3.0 mg/kg IV once every 2 weeks
10996171|NCT01031836|BG002|Baseline|MEDI-545 10.0 mg/kg IV|MEDI-545 10.0 mg/kg IV once every 2 weeks
10996172|NCT01031836|BG003|Baseline|MEDI-545 100 mg SC|MEDI-545 100 mg SC once every 2 weeks
10996173|NCT01031836|BG004|Baseline|MEDI-545 600 mg IV|MEDI-545 600 mg IV once every 4 weeks
10996174|NCT01031836|BG005|Baseline|MEDI-545 1200 mg IV|MEDI-545 1200 mg IV once every 4 weeks
10996175|NCT01031836|BG006|Baseline|Total|Total of all reporting groups
11223669|NCT02354599|EG004|Reported Event|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223670|NCT02354599|EG005|Reported Event|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
11223671|NCT02354690|BG000|Baseline|T Cell Therapy With Vemurafenib Pretreatment|"7 days before tumor harvest, patients will begin taking vemurafenib until admission for lymphodepleting chemotherapy followed by TIL infusion and interleukin-2.~Vemurafenib: Patients will start treatment in a dose of 960 BID 7 days before tumor harvest and ends at the day of admission (day -8).~Lymphodepleting chemotherapy regimen consisting of cyclophosphamide 60 mg/kg for 2 days and fludarabine 25 mg/m2 for 5 days (constitutes day -7 to -1 of admission).~TIL infusion: A tumor is surgically removed in order to isolate, activate and expand tumor infiltrating lymphocytes (TIL) to high numbers. In vitro preparation usually takes 4-6 weeks using the young TIL method.~On day 0 patients receive an infusion of TIL (1x10e9-2x10e11 cells).~Interleukin-2 is administered according to the decrescendo regimen (18 MIU/m2 for 6 hours, 18 MIU/m2 for 12 hours, 18 MIU/m2 for 24 hours followed by 4,5 MIU/m2 for another 3 x 24 hours)"
11224473|NCT02360293|OG001|Outcome|Stay Strong|"Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.~Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device."
10996176|NCT01031836|FG000|Participant Flow|MEDI-545 1.0 mg/kg IV|MEDI-545 1.0 mg/kg IV once every 2 weeks
10996177|NCT01031836|FG001|Participant Flow|MEDI-545 3.0 mg/kg IV|MEDI-545 3.0 mg/kg IV once every 2 weeks
10996178|NCT01031836|FG002|Participant Flow|MEDI-545 10.0 mg/kg IV|MEDI-545 10.0 mg/kg IV once every 2 weeks
10996179|NCT01031836|FG003|Participant Flow|MEDI-545 100 mg SC|MEDI-545 100 mg SC once every 2 weeks
10996180|NCT01031836|FG004|Participant Flow|MEDI-545 600 mg IV|MEDI-545 600 mg IV once every 4 weeks
10996181|NCT01031836|FG005|Participant Flow|MEDI-545 1200 mg IV|MEDI-545 1200 mg IV once every 4 weeks
10996182|NCT01031836|OG000|Outcome|MEDI-545 1.0 mg/kg IV|MEDI-545 1.0 mg/kg IV once every 2 weeks
10996183|NCT01031836|OG001|Outcome|MEID-545 3.0 mg/kg IV|MEID-545 3.0 mg/kg IV once every 2 weeks
10996184|NCT01031836|OG002|Outcome|MEDI-545 10.0 mg/kg IV|MEDI-545 10.0 mg/kg IV once every 2 weeks
10996185|NCT01031836|OG003|Outcome|MEDI-545 100mg SC|MEDI-545 100mg SC once every 2 weeks
10996186|NCT01031836|OG004|Outcome|MEDI-545 600mg IV|MEDI-545 600mg IV once every 4 weeks
10996187|NCT01031836|OG005|Outcome|MEDI-545 1200mg IV|MEDI-545 1200mg IV once every 4 weeks
10996188|NCT01031836|EG000|Reported Event|MEDI-545 1.0 mg/kg IV|MEDI-545 1.0 mg/kg IV once every 2 weeks
10996189|NCT01031836|EG001|Reported Event|MEDI-545 3.0 mg/kg IV|MEDI-545 3.0 mg/kg IV once every 2 weeks
10996190|NCT01031836|EG002|Reported Event|MEDI-545 10.0 mg/kg IV|MEDI-545 10.0 mg/kg IV once every 2 weeks
10996191|NCT01031836|EG003|Reported Event|MEDI-545 100 mg SC|MEDI-545 100 mg SC once every 2 weeks
10996192|NCT01031836|EG004|Reported Event|MEDI-545 600 mg IV|MEDI-545 600 mg IV once every 4 weeks
10996193|NCT01031836|EG005|Reported Event|MEDI-545 1200 mg IV|MEDI-545 1200 mg IV once every 4 weeks
10996194|NCT01031914|BG000|Baseline|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
10996195|NCT01031914|FG000|Participant Flow|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have obstructive sleep apnea (OSA) and will be current CPAP users.
10996196|NCT01031914|OG000|Outcome|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
10996197|NCT01031914|EG000|Reported Event|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
10996198|NCT01031953|BG000|Baseline|Fosaprepitant|
10996199|NCT01031953|FG000|Participant Flow|Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
10996200|NCT01031953|OG000|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
10996201|NCT01031953|OG000|Outcome|Change in Nausea Score From 2 Hours to 12 and 24 Hours|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
10996202|NCT01031953|OG000|Outcome|Participants Who Recieved Fosaprepitant|Number of participants who experienced vomiting episodes from baseline to 24 hours after receiving Fosaprepitant
10996203|NCT01031953|OG000|Outcome|Participants That Received Fosaprepitant|This arm includes only those participants that required the use of second rescue drug after receiving Fosaprepitant
10996204|NCT01031953|OG000|Outcome|Participants That Received Fosaprepitant|Number of participants achieving a Complete Response (CR) up to 24 hours after receiving fosaprepitant
10996205|NCT01031953|OG000|Outcome|Participants That Received Fosaprepitant|participants with self report fatigue or sedation after receiving fosaprepitant
10996206|NCT01031953|OG000|Outcome|Participants That Received Fosaprepitant|Only those in the study arm above that self report headache, dizziness, or pain/soreness at the infusion site are considered in this outcome
10996207|NCT01031953|EG000|Reported Event|Fosaprepitant|
10996208|NCT01031979|BG000|Baseline|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
10996209|NCT01031979|BG001|Baseline|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
10996210|NCT01031979|BG002|Baseline|Total|Total of all reporting groups
10996211|NCT01031979|FG000|Participant Flow|Yohimbime Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
10996212|NCT01031979|FG001|Participant Flow|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
10996213|NCT01031979|OG000|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
10996214|NCT01031979|OG001|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
10996215|NCT01031979|EG000|Reported Event|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
10996216|NCT01031979|EG001|Reported Event|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
10996217|NCT01032018|BG000|Baseline|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
10996218|NCT01032018|BG001|Baseline|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
10996219|NCT01032018|BG002|Baseline|Total|Total of all reporting groups
10996220|NCT01032018|FG000|Participant Flow|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
10996221|NCT01032018|FG001|Participant Flow|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
10996222|NCT01032018|OG000|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
10996223|NCT01032018|OG001|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
10996224|NCT01032018|EG000|Reported Event|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
10996225|NCT01032018|EG001|Reported Event|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
10996226|NCT01032044|BG000|Baseline|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation~Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
10996227|NCT01032044|BG001|Baseline|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)~pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
10996228|NCT01032044|BG002|Baseline|Total|Total of all reporting groups
10996229|NCT01032044|FG000|Participant Flow|Standard Treatment|"Standard high-definition white light endoscopy guided treatment~Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
10996230|NCT01032044|FG001|Participant Flow|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy~pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
10996231|NCT01032044|OG000|Outcome|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation~Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
10996232|NCT01032044|OG001|Outcome|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)~pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
10996233|NCT01032044|EG000|Reported Event|Standard Treatment|"Standard high-definition white light endoscopy guided treatment~Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
10996234|NCT01032044|EG001|Reported Event|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy~pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
10996235|NCT01032070|BG000|Baseline|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
10996236|NCT01032070|BG001|Baseline|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
10996237|NCT01032070|BG002|Baseline|Total|Total of all reporting groups
10996238|NCT01032070|FG000|Participant Flow|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
10996239|NCT01032070|FG001|Participant Flow|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
10996240|NCT01032070|OG000|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
10996241|NCT01032070|OG001|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
10996242|NCT01032070|EG000|Reported Event|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
10996243|NCT01032070|EG001|Reported Event|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
10996244|NCT01032135|BG000|Baseline|Engaged|Participants began treatment in IOP, consistently remained engaged in IOP throughout the study time period. This group did not reach the threshold of needing study intervention.
10996245|NCT01032135|BG001|Baseline|MI-PC Non-Engaged|"Participants began treatment in IOP but were not engaged at week 2. Randomized to receive patient choice.~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
10996246|NCT01032135|BG002|Baseline|MI-IOP Non-Engaged|"Participants began treatment in IOP but were not engaged at week 2. Randomized back to IOP.~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
10996247|NCT01032135|BG003|Baseline|MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks|"Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
10996248|NCT01032135|BG004|Baseline|MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks|"Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized back to IOP.~Motivational Interviewing: 2 sessions at week 2."
10996249|NCT01032135|BG005|Baseline|Total|Total of all reporting groups
10996250|NCT01032135|FG000|Participant Flow|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
10996251|NCT01032135|FG001|Participant Flow|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
10996252|NCT01032135|FG002|Participant Flow|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
10996253|NCT01032135|FG003|Participant Flow|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
10996254|NCT01032135|FG004|Participant Flow|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
10996255|NCT01032135|FG005|Participant Flow|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
10996256|NCT01032135|FG006|Participant Flow|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
10996257|NCT01032135|OG000|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
10996258|NCT01032135|OG001|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
10996259|NCT01032135|OG002|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
10996260|NCT01032135|OG003|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
10996261|NCT01032135|OG004|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
10996262|NCT01032135|OG005|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
10996263|NCT01032135|OG006|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
10996264|NCT01032135|EG000|Reported Event|Engaged|Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.
10996265|NCT01032135|EG001|Reported Event|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are non-engaged.~Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
10996266|NCT01032135|EG002|Reported Event|MI-IOP Non-Engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are non-engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
10996267|NCT01032135|EG003|Reported Event|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Participants start at IOP, Engaged at 2 weeks but disengage between 3 - 8 weeks.~Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
10996268|NCT01032135|EG004|Reported Event|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become non-engaged in weeks 3 - 8.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2"
10996269|NCT01032174|BG000|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
10996270|NCT01032174|BG001|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
10996271|NCT01032174|BG002|Baseline|Total|Total of all reporting groups
10996272|NCT01032174|FG000|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
10996273|NCT01032174|FG001|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
10996274|NCT01032174|OG000|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
10996275|NCT01032174|OG001|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
10996276|NCT01032174|EG000|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
10996277|NCT01032174|EG001|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
10996278|NCT01032200|BG000|Baseline|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
10996279|NCT01032200|BG001|Baseline|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10996280|NCT01032200|BG002|Baseline|Total|Total of all reporting groups
10996281|NCT01032200|FG000|Participant Flow|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
10996282|NCT01032200|FG001|Participant Flow|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10996283|NCT01032200|OG000|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
10996284|NCT01032200|OG001|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10996285|NCT01032200|EG000|Reported Event|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
10996286|NCT01032200|EG001|Reported Event|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10996287|NCT01032239|BG000|Baseline|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
10996288|NCT01032239|BG001|Baseline|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
11223672|NCT02354690|FG000|Participant Flow|T Cell Therapy With Vemurafenib Pretreatment|"7 days before tumor harvest, patients will begin taking vemurafenib until admission for lymphodepleting chemotherapy followed by TIL infusion and interleukin-2.~Vemurafenib: Patients will start treatment in a dose of 960 BID 7 days before tumor harvest and ends at the day of admission (day -8).~Lymphodepleting chemotherapy regimen consisting of cyclophosphamide 60 mg/kg for 2 days and fludarabine 25 mg/m2 for 5 days (constitutes day -7 to -1 of admission).~TIL infusion: A tumor is surgically removed in order to isolate, activate and expand tumor infiltrating lymphocytes (TIL) to high numbers. In vitro preparation usually takes 4-6 weeks using the young TIL method.~On day 0 patients receive an infusion of TIL (1x10e9-2x10e11 cells).~Interleukin-2 is administered according to the decrescendo regimen (18 MIU/m2 for 6 hours, 18 MIU/m2 for 12 hours, 18 MIU/m2 for 24 hours followed by 4,5 MIU/m2 for another 3 x 24 hours)"
11336449|NCT03566810|FG003|Participant Flow|First Reference GXR (Fed), Then Test GXR (Fed)|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt, Germany) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GXR (Merck Nantong, China) on Day 8 in treatment period 2 under fed conditions. There was a wash-out period of 7 days between each treatment period.
11336450|NCT03566810|OG000|Outcome|Test GXR (Fasting)|Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions.
10996289|NCT01032239|BG002|Baseline|Total|Total of all reporting groups
10996290|NCT01032239|FG000|Participant Flow|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
10996291|NCT01032239|FG001|Participant Flow|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication
10996292|NCT01032239|OG000|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
10996293|NCT01032239|OG001|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
10996294|NCT01032239|EG000|Reported Event|ITB-I|Patients implanted with intrathecal baclofen pump
10996295|NCT01032239|EG001|Reported Event|BMT+ITB-NI|Patients randomized to BMT plus patients randomized to ITB but not implanted (treated with one or a combination oral antispastic medication)
10996296|NCT01032291|BG000|Baseline|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996297|NCT01032291|BG001|Baseline|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
10996298|NCT01032291|BG002|Baseline|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996299|NCT01032291|BG003|Baseline|Total|Total of all reporting groups
10996300|NCT01032291|FG000|Participant Flow|Lenalidomide + Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996301|NCT01032291|FG001|Participant Flow|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
10996302|NCT01032291|FG002|Participant Flow|Lenalidomide + Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996303|NCT01032291|OG000|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996304|NCT01032291|OG000|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
10996305|NCT01032291|OG001|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996306|NCT01032291|OG000|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996307|NCT01032291|OG001|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
10996308|NCT01032291|OG002|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996309|NCT01032291|OG001|Outcome|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996310|NCT01032291|EG000|Reported Event|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
10996311|NCT01032291|EG001|Reported Event|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
10996312|NCT01032330|BG000|Baseline|Older Cohort Observation Group|Patients randomized to the observation group will receive no treatment (other than refractive correction).
10996313|NCT01032330|BG001|Baseline|Older Cohort Occlusion Therapy Group|Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996314|NCT01032330|BG002|Baseline|Younger Cohort Observation Group|Patients randomized to the observation group will receive no treatment (other than refractive correction).
10996315|NCT01032330|BG003|Baseline|Younger Cohort Occlusion Therapy Group|Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996316|NCT01032330|BG004|Baseline|Total|Total of all reporting groups
10996317|NCT01032330|FG000|Participant Flow|Older Cohort Observation Group|Older Cohort patients aged 3 to <12 years randomized to the observation group will receive no treatment (other than refractive correction).
10996318|NCT01032330|FG001|Participant Flow|Older Cohort Occlusion Therapy Group|Occlusion treatment: Older cohort patients aged 3 to <12 years randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996319|NCT01032330|FG002|Participant Flow|Younger Cohort Observation Group|Younger cohort patients aged 12 to 35 months randomized to the observation group will receive no treatment (other than refractive correction).
10996320|NCT01032330|FG003|Participant Flow|Younger Cohort Occlusion Therapy Group|Occlusion treatment: Younger cohort patients aged 12 to 35 months randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996321|NCT01032330|OG000|Outcome|Older Cohort Observation Group|Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
10996322|NCT01032330|OG001|Outcome|Older Cohort Occlusion Therapy Group|Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996323|NCT01032330|OG001|Outcome|Older Cohort Occlusion Therapy Group|This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
10996324|NCT01032330|OG000|Outcome|Younger Cohort Observation Group|Younger cohort patients aged 12 to 35 months randomized to the observation group will receive no treatment (other than refractive correction).
10996325|NCT01032330|OG001|Outcome|Younger Cohort Occlusion Therapy Group|Occlusion treatment: Younger cohort patients aged 12 to 35 months randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996326|NCT01032330|OG001|Outcome|Younger Cohort Occlusion Therapy Group|This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
10996327|NCT01032330|OG001|Outcome|Older Cohort Occlusion Group|This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
11336451|NCT03566810|OG001|Outcome|Reference GXR (Fasting)|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/France) either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions.
10996328|NCT01032330|OG000|Outcome|Older Cohort Observation Group|Patients randomized to the observation group will receive no treatment (other than refractive correction).
10996329|NCT01032330|OG001|Outcome|Older Cohort Occlusion Therapy Group|Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996330|NCT01032330|OG002|Outcome|Younger Cohort Observation Group|Patients randomized to the observation group will receive no treatment (other than refractive correction).
10996331|NCT01032330|OG003|Outcome|Younger Cohort Occlusion Therapy Group|Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996332|NCT01032330|OG003|Outcome|Younger Cohort Occlusion Group|This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
10996333|NCT01032330|EG000|Reported Event|Older Cohort Observation Group|Older Cohort patients aged 3 to <12 years randomized to the observation group will receive no treatment (other than refractive correction).
10996334|NCT01032330|EG001|Reported Event|Older Cohort Occlusion Therapy Group|Occlusion treatment: Older cohort patients aged 3 to <12 years randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996335|NCT01032330|EG002|Reported Event|Younger Cohort Observation Group|Younger cohort patients aged 12 to 35 months randomized to the observation group will receive no treatment (other than refractive correction).
10996336|NCT01032330|EG003|Reported Event|Younger Cohort Occlusion Therapy Group|Occlusion treatment: Younger cohort patients aged 12 to 35 months randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
10996337|NCT01032382|BG000|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
10996338|NCT01032382|BG001|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
10996339|NCT01032382|BG002|Baseline|Total|Total of all reporting groups
10996340|NCT01032382|FG000|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
10996341|NCT01032382|FG001|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
10996342|NCT01032382|OG000|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
10996343|NCT01032382|OG001|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
10996344|NCT01032382|EG000|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
10996345|NCT01032382|EG001|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
10996346|NCT01032538|BG000|Baseline|Patients With Knee Osteoarthritis|Patients eglible for medial unicompartmental knee replacement
10996347|NCT01032538|FG000|Participant Flow|Patients With Knee Osteoarthritis|Patients eglible for unicondylar knee replacement
10996348|NCT01032538|OG000|Outcome|KOOS Pain 2 Years|Knee pain score, one of 5 subscores of KOOS
10996349|NCT01032538|OG001|Outcome|KOOS ADL 2 Years|Activities of dayly living score
10996350|NCT01032538|OG000|Outcome|Passive ROM 2 Years|Range of motion measured by physiotherapist
10996351|NCT01032538|EG000|Reported Event|Patients With Knee Osteoarthritis|Patients eglible for unicompartmental knee replacement
10996352|NCT01032629|BG000|Baseline|Placebo|Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.
10996353|NCT01032629|BG001|Baseline|Canagliflozin 100 mg|Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment.
10996354|NCT01032629|BG002|Baseline|Canagliflozin 300 mg|Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.
10996355|NCT01032629|BG003|Baseline|Total|Total of all reporting groups
10996356|NCT01032629|FG000|Participant Flow|Placebo|Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.
10996357|NCT01032629|FG001|Participant Flow|Canagliflozin 100 mg|Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment.
10996358|NCT01032629|FG002|Participant Flow|Canagliflozin 300 mg|Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.
10996359|NCT01032629|OG000|Outcome|Placebo|Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.
10996360|NCT01032629|OG001|Outcome|Canagliflozin 100 mg|Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment.
10996361|NCT01032629|OG002|Outcome|Canagliflozin 300 mg|Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.
10996362|NCT01032629|OG003|Outcome|Canagliflozin (Total)|Participants received one canagliflozin 100 mg or 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.
10996363|NCT01032629|EG000|Reported Event|Placebo|Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.
10996364|NCT01032629|EG001|Reported Event|Canagliflozin 100 mg|Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment.
10996365|NCT01032629|EG002|Reported Event|Canagliflozin 300 mg|Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.
10996366|NCT01032694|BG000|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
10996367|NCT01032694|BG001|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
10996368|NCT01032694|BG002|Baseline|Total|Total of all reporting groups
10996369|NCT01032694|FG000|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
10996370|NCT01032694|FG001|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
10996371|NCT01032694|OG000|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
10996372|NCT01032694|OG001|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
10996373|NCT01032694|EG000|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
10996374|NCT01032694|EG001|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
10996375|NCT01032733|BG000|Baseline|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
10996376|NCT01032733|BG001|Baseline|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
10996377|NCT01032733|BG002|Baseline|Total|Total of all reporting groups
10996378|NCT01032733|FG000|Participant Flow|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
10996379|NCT01032733|FG001|Participant Flow|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
10996380|NCT01032733|OG000|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
10996381|NCT01032733|OG001|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
10996382|NCT01032733|OG000|Outcome|Lifestyle Counseling|
10996383|NCT01032733|EG000|Reported Event|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
10996384|NCT01032733|EG001|Reported Event|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
10996385|NCT01032759|BG000|Baseline|Memantine|Memantine: 20 mg, BID
10996386|NCT01032759|BG001|Baseline|Placebo|"Placebo~Placebo: BID"
10996387|NCT01032759|BG002|Baseline|Total|Total of all reporting groups
10996388|NCT01032759|FG000|Participant Flow|Memantine|Memantine: 20 mg, BID
10996389|NCT01032759|FG001|Participant Flow|Placebo|"Placebo~Placebo: BID"
10996390|NCT01032759|OG000|Outcome|Memantine|Memantine: 20 mg, BID
10996391|NCT01032759|OG001|Outcome|Placebo|"Placebo~Placebo: BID"
10996392|NCT01032759|EG000|Reported Event|Memantine|Memantine: 20 mg, BID
10996393|NCT01032759|EG001|Reported Event|Placebo|"Placebo~Placebo: BID"
10996394|NCT01032837|BG000|Baseline|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
10996395|NCT01032837|BG001|Baseline|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
10996396|NCT01032837|BG002|Baseline|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
10996397|NCT01032837|BG003|Baseline|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
10996398|NCT01032837|BG004|Baseline|Total|Total of all reporting groups
10996399|NCT01032837|FG000|Participant Flow|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
10996400|NCT01032837|FG001|Participant Flow|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
10996401|NCT01032837|FG002|Participant Flow|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
10996402|NCT01032837|FG003|Participant Flow|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
10996403|NCT01032837|OG000|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
10996404|NCT01032837|OG001|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
10996405|NCT01032837|OG002|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
10996406|NCT01032837|OG003|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
11336452|NCT03566810|OG002|Outcome|Test GXR (Fed)|Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions.
10996407|NCT01032837|EG000|Reported Event|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
10996408|NCT01032837|EG001|Reported Event|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
10996409|NCT01032837|EG002|Reported Event|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
10996410|NCT01032837|EG003|Reported Event|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
10996411|NCT01032850|BG000|Baseline|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
10996412|NCT01032850|FG000|Participant Flow|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
10996413|NCT01032850|OG000|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
10996414|NCT01032850|EG000|Reported Event|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
10996415|NCT01032889|BG000|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996416|NCT01032889|BG001|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996417|NCT01032889|BG002|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996418|NCT01032889|BG003|Baseline|Total|Total of all reporting groups
10996419|NCT01032889|FG000|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996420|NCT01032889|FG001|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996421|NCT01032889|FG002|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996422|NCT01032889|OG000|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996423|NCT01032889|OG001|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996424|NCT01032889|OG002|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996425|NCT01032889|EG000|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996426|NCT01032889|EG001|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996427|NCT01032889|EG002|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10996428|NCT01032915|BG000|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
10996429|NCT01032915|BG001|Baseline|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
10996430|NCT01032915|BG002|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
10996431|NCT01032915|BG003|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
10996432|NCT01032915|BG004|Baseline|Total|Total of all reporting groups
10996433|NCT01032915|FG000|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
10996434|NCT01032915|FG001|Participant Flow|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
10996435|NCT01032915|FG002|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
10996436|NCT01032915|FG003|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
10996437|NCT01032915|OG000|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
10996438|NCT01032915|OG001|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
10996439|NCT01032915|OG002|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
10996440|NCT01032915|OG003|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
10996441|NCT01032915|EG000|Reported Event|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
10996442|NCT01032915|EG001|Reported Event|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
10996443|NCT01032915|EG002|Reported Event|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
10996444|NCT01032915|EG003|Reported Event|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
10996445|NCT01032928|BG000|Baseline|Respiratory-Swallow Phase Training|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns~Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
10996446|NCT01032928|FG000|Participant Flow|Respiratory - Swallow Phase Training|Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns
10996447|NCT01032928|OG000|Outcome|Pre-intervention|Subjects eligible for enrollment
10996448|NCT01032928|OG001|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
10996449|NCT01032928|OG002|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
10996450|NCT01032928|OG001|Outcome|One Week Post-intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
10996451|NCT01032928|OG002|Outcome|One Month Post Intervention|VAMC participants were reassessed at one month post treatment
10996452|NCT01032928|EG000|Reported Event|Arm 1|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns~Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
10996453|NCT01032954|BG000|Baseline|Group 1|Subjects have received the lower dose of Botulinum Toxin type A, between 125 to 170 units of Botulinum Toxin type A.
10996454|NCT01032954|BG001|Baseline|Group 2|Subjects have received the intermediate dose of Botulinum Toxin type A, between 171 to 210 units of Botulinum Toxin type A.
10996455|NCT01032954|BG002|Baseline|Group 3|Subjects have received the higher dose of Botulinum Toxin type A, between 211 to 250 units of Botulinum Toxin type A
10996456|NCT01032954|BG003|Baseline|Total|Total of all reporting groups
10996457|NCT01032954|FG000|Participant Flow|125 to 170 Units of Botulinum Toxin Type A|Subjects have received the lower dose of Botulinum Toxin type A
10996458|NCT01032954|FG001|Participant Flow|171 to 210 Units of Botulinum Toxin Type A|Subjects have received the intermediate dose of Botulinum Toxin type A.
10996459|NCT01032954|FG002|Participant Flow|211 to 250 Units of Botulinum Toxin Type A|Subjects have received the higher dose of Botulinum Toxin type A.
10996460|NCT01032954|OG000|Outcome|125 to 170 Units of Botulinum Toxin Type A|Subjects were treated with a total dose of 125 to 170 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
10996461|NCT01032954|OG001|Outcome|171 to 210 Units of Botulinum Toxin Type A|Subjects were treated with a total dose of 171 to 210 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
10996462|NCT01032954|OG002|Outcome|211 to 250 Units of Botulinum Toxin Type A|Subjects were treated with a total dose of 211 to 250 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
10996463|NCT01032954|EG000|Reported Event|125 to 170 Units of Botulinum Toxin Type A|Subjects have received the lower dose of Botulinum Toxin type A.
10996464|NCT01032954|EG001|Reported Event|171 to 210 Units of Botulinum Toxin Type A|Subjects have received the intermediate dose of Botulinum Toxin type A.
10996465|NCT01032954|EG002|Reported Event|211 to 250 Units of Botulinum Toxin Type A|Subjects have received the higher dose of Botulinum Toxin type A.
10996466|NCT01032993|BG000|Baseline|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
10996467|NCT01032993|BG001|Baseline|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
10996468|NCT01032993|BG002|Baseline|Total|Total of all reporting groups
10996469|NCT01032993|FG000|Participant Flow|Coenzyme Q10|The Coenzyme Q10 arm used 600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily for 4 weeks. Active study wafers were ChewQ (ubidecarenone) and were manufactured by Tishcon Corp, (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
10996470|NCT01032993|FG001|Participant Flow|Placebo|The Placebo arm used placebo wafers taken as three wafers two times daily for 4 weeks. Placebo wafers contained the same excipients as the active wafers, but contained no active CoQ10. The wafers looked and tasted identical to active agent, and were manufactured by the same manufacturer of the active agent, Tishcon Corp (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
10877534|NCT00447382|OG001|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
10877535|NCT00447382|EG000|Reported Event|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
10877536|NCT00447382|EG001|Reported Event|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
10877537|NCT00447499|BG000|Baseline|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
10877538|NCT00447499|FG000|Participant Flow|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
10877539|NCT00447499|OG000|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
10877540|NCT00447499|OG000|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
10877541|NCT00447499|OG000|Outcome|Somatuline Autogel (Lanreotide Acetate)|Somatuline Autogel (lanreotide acetate) Injection/Switch Patient
10877542|NCT00447499|EG000|Reported Event|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
10877543|NCT00447590|BG000|Baseline|LAP-BAND|All subjects who received the LAP-BAND System.
10877544|NCT00447590|FG000|Participant Flow|LAP-BAND|All subjects who received the LAP-BAND System.
10877545|NCT00447590|OG000|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
10877546|NCT00447590|EG000|Reported Event|LAP-BAND|All subjects who received the LAP-BAND System.
10996471|NCT01032993|OG000|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
10877547|NCT00447694|BG000|Baseline|Deferasirox|Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
10877548|NCT00447694|FG000|Participant Flow|Deferasirox|Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
10877549|NCT00447694|OG000|Outcome|Deferasirox|Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
10877550|NCT00447694|EG000|Reported Event|All Patients|Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
10877551|NCT00447772|BG000|Baseline|Dysport® 500 U - Total Study Population|"Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.~The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments."
10877552|NCT00447772|FG000|Participant Flow|Dysport® 500 U - Total Study Population|"Patients with heterogeneous forms of CD were given a single intramuscular (i.m.) injection of 500 units (U) Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 millilitres (ml) 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.~The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments."
10877553|NCT00447772|OG000|Outcome|Rotatory Torticollis|Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
10877554|NCT00447772|OG001|Outcome|Laterocollis|Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
10877555|NCT00447772|OG002|Outcome|Dysport® 500 U - Total Study Population|"Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.~The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments."
10996472|NCT01032993|OG001|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
10996473|NCT01032993|EG000|Reported Event|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
10996474|NCT01032993|EG001|Reported Event|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
10877556|NCT00447772|OG000|Outcome|Dysport® 500 U - Total Study Population|"Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.~The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments."
10877557|NCT00447772|EG000|Reported Event|Dysport® 500 U - Total Study Population|"Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.~The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments."
10877558|NCT00447876|BG000|Baseline|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
10877559|NCT00447876|BG001|Baseline|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
10877560|NCT00447876|BG002|Baseline|Total Title|
10877561|NCT00447876|FG000|Participant Flow|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
10877562|NCT00447876|FG001|Participant Flow|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
10877563|NCT00447876|OG000|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
10877564|NCT00447876|OG001|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
10877565|NCT00447876|EG000|Reported Event|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
10877566|NCT00447876|EG001|Reported Event|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
10879441|NCT00457743|EG001|Reported Event|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
10879442|NCT00457743|EG002|Reported Event|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
10879443|NCT00457795|BG000|Baseline|Brimonidine 0.1%|Brimonidine 0.1%
10879444|NCT00457795|FG000|Participant Flow|Brimonidine 0.1%|Brimonidine 0.1%
10879445|NCT00457795|OG000|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
10879446|NCT00457795|EG000|Reported Event|Brimonidine 0.1%|Brimonidine 0.1%
10879447|NCT00457821|BG000|Baseline|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
10879448|NCT00457821|BG001|Baseline|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
10877567|NCT00447902|BG000|Baseline|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
10877568|NCT00447902|BG001|Baseline|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
10877569|NCT00447902|BG002|Baseline|Total|Total of all reporting groups
10877570|NCT00447902|FG000|Participant Flow|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
10877571|NCT00447902|FG001|Participant Flow|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
10877572|NCT00447902|OG000|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
10877573|NCT00447902|OG001|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
10877574|NCT00447902|EG000|Reported Event|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
10877575|NCT00447902|EG001|Reported Event|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
10877576|NCT00448019|BG000|Baseline|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
10877577|NCT00448019|FG000|Participant Flow|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
10877578|NCT00448019|OG000|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
10877579|NCT00448019|EG000|Reported Event|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
10877580|NCT00448123|BG000|Baseline|Placebo|Placebo Group
10877581|NCT00448123|BG001|Baseline|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
10877582|NCT00448123|BG002|Baseline|Total|Total of all reporting groups
10877583|NCT00448123|FG000|Participant Flow|Placebo|None active placebo orally per day for up to 10 days.
10877584|NCT00448123|FG001|Participant Flow|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
10877585|NCT00448123|OG000|Outcome|Placebo|Placebo Group
10877586|NCT00448123|OG001|Outcome|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
10877587|NCT00448123|OG000|Outcome|Placebo|Active placebo orally per day for up to 10 days.
10877588|NCT00448123|OG001|Outcome|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
10877589|NCT00448123|OG000|Outcome|Placebo|"Placebo~Placebo: Placebo"
10877590|NCT00448123|EG000|Reported Event|Placebo|Placebo Group
10877591|NCT00448123|EG001|Reported Event|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
10877592|NCT00448136|BG000|Baseline|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
10877593|NCT00448136|BG001|Baseline|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
10877594|NCT00448136|BG002|Baseline|Total|Total of all reporting groups
10877595|NCT00448136|FG000|Participant Flow|Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
10877596|NCT00448136|FG001|Participant Flow|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, orally (PO), twice daily (BID) on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
10877597|NCT00448136|OG000|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
10877598|NCT00448136|OG001|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
10877599|NCT00448136|EG000|Reported Event|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
10877600|NCT00448136|EG001|Reported Event|Bevacizumab + Capecitabine|Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
10877601|NCT00448175|BG000|Baseline|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
10877602|NCT00448175|BG001|Baseline|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
10877603|NCT00448175|BG002|Baseline|Total|Total of all reporting groups
10877604|NCT00448175|FG000|Participant Flow|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
10877605|NCT00448175|FG001|Participant Flow|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
10877606|NCT00448175|OG000|Outcome|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
10877607|NCT00448175|OG001|Outcome|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
10877608|NCT00448175|EG000|Reported Event|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
10877609|NCT00448175|EG001|Reported Event|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
10877610|NCT00448201|BG000|Baseline|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
10877611|NCT00448201|FG000|Participant Flow|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
10877612|NCT00448201|OG000|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
10877613|NCT00448201|OG000|Outcome|Day 60|60 days post-transplant
10877614|NCT00448201|OG001|Outcome|Day 90|90 days post-transplant
10877615|NCT00448201|EG000|Reported Event|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
10877616|NCT00448227|BG000|Baseline|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
10877617|NCT00448227|FG000|Participant Flow|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
10877618|NCT00448227|OG000|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
10877619|NCT00448227|OG001|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
10877620|NCT00448227|OG002|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
10877621|NCT00448227|OG003|Outcome|Total|
10877622|NCT00448227|EG000|Reported Event|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
10877623|NCT00448279|BG000|Baseline|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
10877624|NCT00448279|BG001|Baseline|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
10877625|NCT00448279|BG002|Baseline|Total|Total of all reporting groups
10877626|NCT00448279|FG000|Participant Flow|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
10879449|NCT00457821|BG002|Baseline|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
10996475|NCT01033019|BG000|Baseline|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
10879450|NCT00457821|BG003|Baseline|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
10879451|NCT00457821|BG004|Baseline|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
10879452|NCT00457821|BG005|Baseline|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
10879453|NCT00457821|BG006|Baseline|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
10879454|NCT00457821|BG007|Baseline|Part 2: Placebo|Part 2: placebo q12h; 28 days
10879455|NCT00457821|BG008|Baseline|Total|Total of all reporting groups
10879456|NCT00457821|FG000|Participant Flow|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
10879457|NCT00457821|FG001|Participant Flow|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
10879458|NCT00457821|FG002|Participant Flow|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
10879459|NCT00457821|FG003|Participant Flow|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
10879460|NCT00457821|FG004|Participant Flow|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
10879461|NCT00457821|FG005|Participant Flow|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
10879462|NCT00457821|FG006|Participant Flow|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
10879463|NCT00457821|FG007|Participant Flow|Part 2: Placebo|Part 2: placebo q12h; 28 days
10879464|NCT00457821|OG000|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
10879465|NCT00457821|OG001|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
10879466|NCT00457821|OG000|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
10879467|NCT00457821|OG001|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
10879468|NCT00457821|OG002|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
10879469|NCT00457821|OG003|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
10879470|NCT00457821|OG004|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
10879471|NCT00457821|OG000|Outcome|Placebo|Subjects given placebo every 12 hours (q12h) for 28 days.
10879472|NCT00457821|OG001|Outcome|150 mg Ivacaftor q12h|Subjects given 150 mg of ivacaftor q12h for 28 days.
10879473|NCT00457821|OG002|Outcome|250 mg Ivacaftor q12h|Subjects given 250 mg of ivacaftor q12h for 28 days.
10879474|NCT00457821|EG000|Reported Event|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
10879475|NCT00457821|EG001|Reported Event|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
10879476|NCT00457821|EG002|Reported Event|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
10879477|NCT00457821|EG003|Reported Event|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
10879478|NCT00457821|EG004|Reported Event|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
10879479|NCT00457977|BG000|Baseline|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
10879480|NCT00457977|BG001|Baseline|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
10879481|NCT00457977|BG002|Baseline|Total|Total of all reporting groups
10879482|NCT00457977|FG000|Participant Flow|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
10879483|NCT00457977|FG001|Participant Flow|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
10879484|NCT00457977|OG000|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
10879485|NCT00457977|OG001|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
10879486|NCT00457977|EG000|Reported Event|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
10879487|NCT00457977|EG001|Reported Event|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
10879488|NCT00458211|BG000|Baseline|Experimental|Open label change to ziprasidone
10879489|NCT00458211|FG000|Participant Flow|Experimental|Open label change to ziprasidone up to 120mg twice a day with meals
10879490|NCT00458211|OG000|Outcome|Experimental|Open label change to ziprasidone
10879491|NCT00458211|OG000|Outcome|Experimental|All subjects, 17 at Buffalo and 19 at Bronx were given Ziprasidone.
10879492|NCT00458211|OG000|Outcome|Experimental|Open label change to ziprasidone up to 120mg twice a day with meals, 17 at Buffalo, 19 at Bronx
10879493|NCT00458211|OG000|Outcome|Experimental|Open label change to ziprasidone up to 120mg twice a day with meals
10879494|NCT00458211|OG000|Outcome|Experimental|"Open label change to ziprasidone~ziprasidone: Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks"
10879495|NCT00458211|EG000|Reported Event|Experimental|Open label change to ziprasidone
10879496|NCT00458237|BG000|Baseline|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10879497|NCT00458237|BG001|Baseline|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10879498|NCT00458237|BG002|Baseline|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10879499|NCT00458237|BG003|Baseline|Total|Total of all reporting groups
10996476|NCT01033019|BG001|Baseline|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
10996477|NCT01033019|BG002|Baseline|Total|Total of all reporting groups
10996478|NCT01033019|FG000|Participant Flow|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
10996479|NCT01033019|FG001|Participant Flow|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
10996480|NCT01033019|OG000|Outcome|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
10996481|NCT01033019|OG001|Outcome|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
10996482|NCT01033019|EG000|Reported Event|LDE225 0.75% - sBCC|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
10996483|NCT01033019|EG001|Reported Event|Vehicle - sBCC|Participants topically applied matching placebo cream twice daily for 6 weeks.
10996484|NCT01033019|EG002|Reported Event|LDE225 0.75% - nBCC|
10996485|NCT01033071|BG000|Baseline|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996486|NCT01033071|BG001|Baseline|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996487|NCT01033071|BG002|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996488|NCT01033071|BG003|Baseline|Total|Total of all reporting groups
10996489|NCT01033071|FG000|Participant Flow|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996490|NCT01033071|FG001|Participant Flow|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996491|NCT01033071|FG002|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996492|NCT01033071|OG000|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996493|NCT01033071|OG001|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996494|NCT01033071|OG002|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996495|NCT01033071|EG000|Reported Event|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996496|NCT01033071|EG001|Reported Event|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996497|NCT01033071|EG002|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
10996498|NCT01033136|BG000|Baseline|Multiple Channel Exposure Therapy (MCET-V)|MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
10996499|NCT01033136|BG001|Baseline|Cognitive Processing Therapy (CPT)|CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
10996500|NCT01033136|BG002|Baseline|Total|Total of all reporting groups
10996501|NCT01033136|FG000|Participant Flow|Multiple Channel Exposure Therapy (MCET-V)|MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
10996502|NCT01033136|FG001|Participant Flow|Cognitive Processing Therapy (CPT)|CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
10996503|NCT01033136|OG000|Outcome|Multiple Channel Exposure Therapy (MCET-V)|MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
10996504|NCT01033136|OG001|Outcome|Cognitive Processing Therapy (CPT)|CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
10996505|NCT01033136|OG000|Outcome|Multiple Channel Exposure Therapy -Veterans (MCET-V)|Multiple Channel Exposure Therapy -Veterans (MCET-V) is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
10996506|NCT01033136|OG001|Outcome|Cognitive Processing Therapy (CPT)|Cognitive Processing Therapy (CPT) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
10996507|NCT01033136|EG000|Reported Event|Multiple Channel Exposure Therapy -Veterans (MCET-V)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy-Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
10996508|NCT01033136|EG001|Reported Event|Cognitive Processing Therapy (CPT)|"CPT is a cognitive-behavioral treatment for persons with PTSD~Cognitive-Processing Therapy: Participants will be randomly assigned to receive either MCET-V or cognitive processing therapy (CPT), a standard PTSD treatment. Patients in both the MCET-V and CPT conditions will receive 12, 90-minute sessions of individual therapy twice a week over a 6-week period."
10996509|NCT01033227|BG000|Baseline|No Drug|
10996510|NCT01033227|BG001|Baseline|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
10996511|NCT01033227|BG002|Baseline|Total|Total of all reporting groups
10996512|NCT01033227|FG000|Participant Flow|No Drug|This group did not receive anything additional in the no drug arm. The treatment group received the study drug and the non treatment group received no drug.
10996513|NCT01033227|FG001|Participant Flow|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
10996514|NCT01033227|OG000|Outcome|No Drug|Will not receive study drug, there is no placebo in this study. The patient will know they are not receiving the study drug.
10996515|NCT01033227|OG001|Outcome|Sodium Nitrite Injection, USP|Administration of sodium nitrite injection, USP
10996516|NCT01033227|OG000|Outcome|No Drug|No study drug administered
10996517|NCT01033227|OG001|Outcome|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
10996518|NCT01033227|EG000|Reported Event|No Drug|This group received no study drug and no placebo. They received standard of care treatment.
10996519|NCT01033227|EG001|Reported Event|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
10996520|NCT01033240|BG000|Baseline|Sorafenib|Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996521|NCT01033240|BG001|Baseline|CS-1008 6/2 mg/kg + Sorafenib|Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996522|NCT01033240|BG002|Baseline|CS-1008 6/6 mg/kg + Sorafenib|Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996523|NCT01033240|BG003|Baseline|Total|Total of all reporting groups
10996524|NCT01033240|FG000|Participant Flow|Sorafenib|Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996525|NCT01033240|FG001|Participant Flow|CS-1008 6/2 mg/kg + Sorafenib|Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996526|NCT01033240|FG002|Participant Flow|CS-1008 6/6 mg/kg + Sorafenib|Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996527|NCT01033240|OG000|Outcome|Sorafenib|Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996528|NCT01033240|OG001|Outcome|CS-1008 6/2 mg/kg + Sorafenib|Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996529|NCT01033240|OG002|Outcome|CS-1008 6/6 mg/kg + Sorafenib|Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996530|NCT01033240|EG000|Reported Event|Sorafenib|Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996531|NCT01033240|EG001|Reported Event|CS-1008 6/2 mg/kg + Sorafenib|Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996532|NCT01033240|EG002|Reported Event|CS-1008 6/6 mg/kg + Sorafenib|Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
10996533|NCT01033383|BG000|Baseline|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
10996534|NCT01033383|BG001|Baseline|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
10996535|NCT01033383|BG002|Baseline|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
10996536|NCT01033383|BG003|Baseline|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
10996537|NCT01033383|BG004|Baseline|Total|Total of all reporting groups
10996538|NCT01033383|FG000|Participant Flow|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
10996539|NCT01033383|FG001|Participant Flow|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
10996540|NCT01033383|FG002|Participant Flow|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
10996541|NCT01033383|FG003|Participant Flow|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
11336453|NCT03566810|OG003|Outcome|Reference GXR (Fed)|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/France) either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions.
10996542|NCT01033383|OG000|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
10996543|NCT01033383|OG001|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
10996544|NCT01033383|OG002|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
10996545|NCT01033383|OG003|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
10996546|NCT01033383|EG000|Reported Event|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
10996547|NCT01033383|EG001|Reported Event|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
10996548|NCT01033383|EG002|Reported Event|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
10996549|NCT01033383|EG003|Reported Event|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
10996550|NCT01033422|BG000|Baseline|CF101 1mg|"CF101 1 mg orally q12 hours~CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks"
10996551|NCT01033422|BG001|Baseline|CF101 2mg|"CF101 2 mg orally q12 hours~CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks"
10996552|NCT01033422|BG002|Baseline|Placebo|"matching placebo orally q12 hours~Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks"
10996553|NCT01033422|BG003|Baseline|Total|Total of all reporting groups
10996554|NCT01033422|FG000|Participant Flow|CF101 1mg|"CF101 1 mg orally q12 hours~CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks"
10996555|NCT01033422|FG001|Participant Flow|CF101 2mg|"CF101 2 mg orally q12 hours~CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks"
10996556|NCT01033422|FG002|Participant Flow|Placebo|"matching placebo orally q12 hours~Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks"
10996557|NCT01033422|OG000|Outcome|CF101 1mg|"CF101 1 mg orally q12 hours~CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks"
10996558|NCT01033422|OG001|Outcome|CF101 2mg|"CF101 2 mg orally q12 hours~CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks"
10996559|NCT01033422|OG002|Outcome|Placebo|"matching placebo orally q12 hours~Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks"
10996560|NCT01033422|EG000|Reported Event|CF101 1mg|"CF101 1 mg orally q12 hours~CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks"
10996561|NCT01033422|EG001|Reported Event|CF101 2mg|"CF101 2 mg orally q12 hours~CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks"
10996562|NCT01033422|EG002|Reported Event|Placebo|"matching placebo orally q12 hours~Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks"
10996563|NCT01033448|BG000|Baseline|Pegylated Interferon (Peginterferon) Alfa-2a|Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks
10996564|NCT01033448|FG000|Participant Flow|Pegylated Interferon (Peginterferon) Alfa-2a|Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks
10996565|NCT01033448|OG000|Outcome|CHC Genotype 1|Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered 1000-1200 mg ribavirin were administered orally in split doses in the morning and in the evening for 24 weeks.
10996566|NCT01033448|OG000|Outcome|CHC Genotype 2 and 3|Participants received peginterferon alfa-2a 180 mcg in 0.5 mL solution administered SC once weekly plus ribavirin 800 mg orally in split doses in the morning and in the evening for 24 weeks.
10996567|NCT01033448|OG000|Outcome|Pegylated Interferon (Peginterferon) Alfa2a|Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks.
10996568|NCT01033448|EG000|Reported Event|Pegylated Interferon Alfa2a (Peginterferon)|Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks.
10996569|NCT01033487|BG000|Baseline|Entire Study Population|Includes all participants randomized to receive PBO Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 180 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 580 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 1450 mcg dry powder first, Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first.
10996570|NCT01033487|FG000|Participant Flow|PBO,PF-03635659 180,Spiriva18,PF-03635659 580,PF-03635659 1450|Single oral inhalation dose of placebo (PBO) matched with Spiriva(tiotropium) 18 microgram (mcg) capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
10996571|NCT01033487|FG001|Participant Flow|PF-03635659 180,PF-03635659 580,PBO,PF-03635659 1450,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period,single oral inhalation dose of placebo matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
10996572|NCT01033487|FG002|Participant Flow|PF-03635659 580,PF-03635659 1450,PF-03635659 180,Spiriva18,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
11336454|NCT03566810|EG000|Reported Event|Test GXR (Fasting)|Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions.
10996573|NCT01033487|FG003|Participant Flow|PF-03635659 1450,Spiriva18,PF-03635659 580,PBO,PF-03635659 180|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period,single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(Tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
10996574|NCT01033487|FG004|Participant Flow|Spiriva18,PBO,PF-03635659 1450,PF-03635659 180,PF-03635659 580|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
10996575|NCT01033487|FG005|Participant Flow|PF-03635659 1450,PF-03635659 580,Spiriva18,PF-03635659 180,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva (tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium)18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated byat least 7 days.
10996576|NCT01033487|FG006|Participant Flow|Spiriva18,PF-03635659 1450,PBO,PF-03635659 580,PF-03635659 180|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
10996577|NCT01033487|FG007|Participant Flow|PBO,Spiriva18,PF-03635659 180,PF-03635659 1450,PF-03635659 580|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
10996578|NCT01033487|FG008|Participant Flow|PF-03635659 180,PBO,PF-03635659 580,Spiriva18,PF-03635659 1450|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
11007578|NCT01091519|FG000|Participant Flow|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
11007579|NCT01091519|FG001|Participant Flow|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
10996579|NCT01033487|FG009|Participant Flow|PF-03635659 580,PF-03635659 180,PF-03635659 1450,PBO,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
10996580|NCT01033487|OG000|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
10996581|NCT01033487|OG001|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
10996582|NCT01033487|OG002|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
10996583|NCT01033487|OG003|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
10996584|NCT01033487|OG004|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
10996585|NCT01033487|OG000|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
10996586|NCT01033487|OG001|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
10996587|NCT01033487|EG000|Reported Event|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
10996588|NCT01033487|EG001|Reported Event|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
10996589|NCT01033487|EG002|Reported Event|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
10996590|NCT01033487|EG003|Reported Event|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
10996591|NCT01033487|EG004|Reported Event|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
10996592|NCT01033565|BG000|Baseline|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
10996593|NCT01033565|FG000|Participant Flow|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
10996594|NCT01033565|OG000|Outcome|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
10996595|NCT01033565|EG000|Reported Event|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
10996596|NCT01033643|BG000|Baseline|MK-3614 0.25 mg (Panel A)|Participants received 0.25 mg of MK-3614 twice daily (BID) every 12 hours orally for 10 days.
10996597|NCT01033643|BG001|Baseline|MK-3614 0.50/0.25 mg (Panel B)|Participants received 0.50 mg of MK-3614 in the morning (AM) and 0.25 mg of MK-3614 in the evening (PM), 12 hours apart orally for 10 days.
10996598|NCT01033643|BG002|Baseline|MK-3614 0.50/0.25 mg (Panel C Repeat)|Per protocol amendment, the Panel B dose was repeated, and participants received instead 0.50 mg of MK-3614 in the AM, and 0.25 mg of MK-3614 in the PM, 12 hours apart orally for 10 days.
10996599|NCT01033643|BG003|Baseline|MK-3614 0.50 mg (Panel D)|Participants received single day dose of 0.50 mg of MK-3614 three times a day (TID) every 8 hours on Day 1 followed by a wash out period for Days 2, 3 and multiple doses of 0.50 mg of MK-3614 BID every 12 hours orally for 10 days (Days 4-13).
10996600|NCT01033643|BG004|Baseline|Placebo (All Panels)|Participants received a dose matched placebo orally according to randomization.
10846568|NCT00278148|OG000|Outcome|Erlotinib, Paclitaxel, and Carboplatin With Radiation|"carboplatin: AUC2 weekly x 3 weeks~Tarceva: Daily~paclitaxel: 50mg/m2/weekly x 3 weeks~conventional surgery: conventional surgery~radiation therapy: 150 cGy bid"
10996601|NCT01033643|BG005|Baseline|Total|Total of all reporting groups
10996602|NCT01033643|FG000|Participant Flow|MK-3614 0.25 mg (Panel A)|Participants received 0.25 mg of MK-3614 twice daily (BID) every 12 hours orally for 10 days.
10996603|NCT01033643|FG001|Participant Flow|MK-3614 0.50/0.25 mg (Panel B)|Participants received 0.50 mg of MK-3614 in the morning (AM) and 0.25 mg of MK-3614 in the evening (PM), 12 hours apart orally for 10 days.
10996604|NCT01033643|FG002|Participant Flow|MK-3614 0.50/0.25 mg (Panel C Repeat)|Per protocol amendment, the Panel B dose was repeated, and participants received instead 0.50 mg of MK-3614 in the AM, and 0.25 mg of MK-3614 in the PM, 12 hours apart orally for 10 days.
10996605|NCT01033643|FG003|Participant Flow|MK-3614 0.50 mg (Panel D)|Participants received single day dose of 0.50 mg of MK-3614 three times a day (TID) every 8 hours on Day 1 followed by a wash out period for Days 2, 3 and multiple doses of 0.50 mg of MK-3614 BID every 12 hours orally for 10 days (Days 4-13).
10996606|NCT01033643|FG004|Participant Flow|MK-3614 0.50 mg (Panel E)|Participants were to receive 0.50 mg BID every 12 hours apart or a matching placebo on Day 1 followed by 3 doses (0.50/0.50/0.25 mg) of MK-3614 each 8 hours apart on Day 2, three doses of 0.50 mg of MK-3614 8 hours apart on Days 3, 4 and 0.75 mg of MK-3614 BID every 12 hours on Days 5-14. No participants were enrolled in this group.
10996607|NCT01033643|FG005|Participant Flow|Placebo (All Panels)|Participants received a dose matched placebo orally according to randomization.
10996608|NCT01033643|OG000|Outcome|MK-3614 0.25 mg (Panel A)|Participants received 0.25 mg of MK-3614 twice daily (BID) every 12 hours orally for 10 days.
10996609|NCT01033643|OG001|Outcome|MK-3614 0.50/0.25 mg (Panel B)|Participants received 0.50 mg of MK-3614 in the morning (AM) and 0.25 mg of MK-3614 in the evening (PM), 12 hours apart orally for 10 days.
10996610|NCT01033643|OG002|Outcome|MK-3614 0.50/0.25 mg (Panel C Repeat)|Per protocol amendment, the Panel B dose was repeated, and participants received instead 0.50 mg of MK-3614 in the AM, and 0.25 mg of MK-3614 in the PM, 12 hours apart orally for 10 days.
10996611|NCT01033643|OG003|Outcome|MK-3614 0.50 mg (Panel D)|Participants received single day dose of 0.50 mg of MK-3614 three times a day (TID) every 8 hours on Day 1 followed by a wash out period for Days 2, 3 and multiple doses of 0.50 mg of MK-3614 BID every 12 hours orally for 10 days (Days 4-13).
10996612|NCT01033643|OG004|Outcome|Placebo (All Panels)|Participants received a dose matched placebo orally according to randomization.
10996613|NCT01033643|OG003|Outcome|MK-3614 0.50 mg BID (Panel D)|Participants received 0.50 mg of MK-3614 BID every 12 hours orally for 10 days (Days 4-13).
10996614|NCT01033643|OG003|Outcome|MK-3614 0.50 mg TID (Panel D)|Participants received single day dose of 0.50 mg of MK-3614 three times a day (TID) every 8 hours orally on Day 1.
10996615|NCT01033643|EG000|Reported Event|MK-3614 0.25 mg (Panel A)|Participants received 0.25 mg of MK-3614 twice daily (BID) every 12 hours orally for 10 days.
10996616|NCT01033643|EG001|Reported Event|MK-3614 0.50/0.25 mg (Panel B)|Participants received 0.50 mg of MK-3614 in the morning (AM) and 0.25 mg of MK-3614 in the evening (PM), 12 hours apart orally for 10 days.
10996617|NCT01033643|EG002|Reported Event|MK-3614 0.50/0.25 mg (Panel C Repeat)|Per protocol amendment, the Panel B dose was repeated, and participants received instead 0.50 mg of MK-3614 in the AM, and 0.25 mg of MK-3614 in the PM, 12 hours apart orally for 10 days.
10996618|NCT01033643|EG003|Reported Event|MK-3614 0.50 mg (Panel D)|Participants received single day dose of 0.50 mg of MK-3614 three times a day (TID) every 8 hours on Day 1 followed by a wash out period for Days 2, 3 and multiple doses of 0.50 mg of MK-3614 BID every 12 hours orally for 10 days (Days 4-13).
10996619|NCT01033643|EG004|Reported Event|Placebo (All Panels)|Participants received a dose matched placebo orally according to randomization.
10996620|NCT01033734|BG000|Baseline|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight ≤23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996621|NCT01033734|FG000|Participant Flow|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to (≤) 23 kilogram (kg) received 3 milligrams per kilogram (mg/kg); participants with body weight more than (>) 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 milligrams (mg). For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996622|NCT01033734|OG000|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996623|NCT01033734|OG001|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996624|NCT01033734|OG002|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996625|NCT01033734|OG000|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996626|NCT01033734|OG001|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996627|NCT01033734|OG002|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996628|NCT01033734|OG003|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996629|NCT01033734|EG000|Reported Event|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996630|NCT01033734|EG001|Reported Event|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996631|NCT01033734|EG002|Reported Event|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996632|NCT01033734|EG003|Reported Event|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
10996633|NCT01033747|BG000|Baseline|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
10996634|NCT01033747|BG001|Baseline|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
10996635|NCT01033747|BG002|Baseline|Total|Total of all reporting groups
10996636|NCT01033747|FG000|Participant Flow|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
10996637|NCT01033747|FG001|Participant Flow|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
10996638|NCT01033747|OG000|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
10996639|NCT01033747|OG001|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
10996640|NCT01033747|EG000|Reported Event|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on the same deferasirox treatment during the comparative prolongation study(NCT00379483)and at the beginning of the 5-year non-comparative extension study
10996641|NCT01033747|EG001|Reported Event|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg/kg to 30 mg/kg deferasirox orally daily at the beginning of the 5-year non-comparative extension study.
11336455|NCT03566810|EG001|Reported Event|Reference GXR (Fasting)|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/France) either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions.
11336456|NCT03566810|EG002|Reported Event|Test GXR (Fed)|Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions.
10877627|NCT00448279|FG001|Participant Flow|Chemotherapy Plus (+) Trastuzumab|Participants received trastuzumab at either 2 milligrams per kilogram (mg/kg), intravenously (IV), every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
10877628|NCT00448279|OG000|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
10877629|NCT00448279|OG001|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
10877630|NCT00448279|EG000|Reported Event|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
10877631|NCT00448279|EG001|Reported Event|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
10877632|NCT00448344|BG000|Baseline|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
10877633|NCT00448344|BG001|Baseline|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
10877634|NCT00448344|BG002|Baseline|Total|Total of all reporting groups
10877635|NCT00448344|FG000|Participant Flow|Family-supported Smoking Cessation|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
10877636|NCT00448344|FG001|Participant Flow|Standard Smoking Cessation|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
10877637|NCT00448344|OG000|Outcome|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
10877638|NCT00448344|OG001|Outcome|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
10877639|NCT00448344|EG000|Reported Event|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
10877640|NCT00448344|EG001|Reported Event|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
10877641|NCT00448357|BG000|Baseline|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis~Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .~Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
10877642|NCT00448357|FG000|Participant Flow|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis~Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .~Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
10877643|NCT00448357|OG000|Outcome|Low Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
10877644|NCT00448357|OG001|Outcome|Intermediate Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
10877645|NCT00448357|OG002|Outcome|High Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
10877646|NCT00448357|OG000|Outcome|Dose Level 1|Target AUC/24 hrs of 4800 micrometer (uM)-min +/-15%
10877647|NCT00448357|OG001|Outcome|Dose Level 2|Target AUC/24 hrs of 5760 uM-min +/- 15%
10877648|NCT00448357|OG002|Outcome|Dose Level 3|Target AUC/24 hrs of 6912 uM-min +/- 15%
10877649|NCT00448357|OG003|Outcome|Dose Level 4|Target AUC/24 hrs of 7603 uM-min+/- 15%
10877650|NCT00448357|OG004|Outcome|Dose Level 5|Target AUC/24 hrs of 8363 uM-min+/- 15%
10877651|NCT00448357|OG000|Outcome|Dose Level 1|Target AUC/24 hrs of 4800 uM-min +/-15%
10996642|NCT01033773|BG000|Baseline|Intervention|"All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.~Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications.~Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters."
10996643|NCT01033773|FG000|Participant Flow|Diabetes Education and Medication Management|"All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.~Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications.~Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters."
10996644|NCT01033773|OG000|Outcome|Intervention|"All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.~Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications.~Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters."
10996645|NCT01033773|EG000|Reported Event|Intervention|"All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.~Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications.~Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters."
10996646|NCT01033825|BG000|Baseline|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
10996647|NCT01033825|BG001|Baseline|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
10996648|NCT01033825|BG002|Baseline|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
10996649|NCT01033825|BG003|Baseline|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
10996650|NCT01033825|BG004|Baseline|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
10996651|NCT01033825|BG005|Baseline|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
10996652|NCT01033825|BG006|Baseline|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
10996653|NCT01033825|BG007|Baseline|Total|Total of all reporting groups
10996654|NCT01033825|FG000|Participant Flow|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
10996655|NCT01033825|FG001|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
10996656|NCT01033825|FG002|Participant Flow|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
10996657|NCT01033825|FG003|Participant Flow|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
10996658|NCT01033825|FG004|Participant Flow|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
10996659|NCT01033825|FG005|Participant Flow|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
10996660|NCT01033825|FG006|Participant Flow|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
10996661|NCT01033825|OG000|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
10996662|NCT01033825|OG001|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
10996663|NCT01033825|OG002|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
10996664|NCT01033825|OG003|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
10996665|NCT01033825|OG004|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
10996666|NCT01033825|OG000|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
10996667|NCT01033825|OG003|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
10996668|NCT01033825|OG004|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
10996669|NCT01033825|OG005|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
10996670|NCT01033825|OG006|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
10996671|NCT01033825|OG002|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
10996672|NCT01033825|EG000|Reported Event|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
10996673|NCT01033825|EG001|Reported Event|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
10996674|NCT01033825|EG002|Reported Event|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
10996675|NCT01033825|EG003|Reported Event|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
10846569|NCT00278148|OG000|Outcome|Erlotinib, Paclitaxel, and Carboplatin With Radiation|Participants received weekly Paclitaxel and Carboplatin (AUC 2) with daily oral Erlotinib for 28 days concurrent with twice daily thoracic radiation.
10846570|NCT00278148|EG000|Reported Event|Dose Level A:50 mg OSI-774/50 mg/m2|50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
10996676|NCT01033825|EG004|Reported Event|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
10996677|NCT01033851|BG000|Baseline|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
10996678|NCT01033851|BG001|Baseline|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
10996679|NCT01033851|BG002|Baseline|Total|Total of all reporting groups
10996680|NCT01033851|FG000|Participant Flow|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
10996681|NCT01033851|FG001|Participant Flow|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
10996682|NCT01033851|OG000|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
10996683|NCT01033851|OG001|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
10996684|NCT01033851|EG000|Reported Event|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
10996685|NCT01033851|EG001|Reported Event|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
10996686|NCT01033864|BG000|Baseline|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
10996687|NCT01033864|BG001|Baseline|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
10996688|NCT01033864|BG002|Baseline|Total|Total of all reporting groups
10996689|NCT01033864|FG000|Participant Flow|Mycophenolate Mofetil (MMF)/Prednisone|Participants were administered MMF tablets or capsules, orally (PO), at a dose prescribed by their physician and prednisone up to 5 milligrams (mg) PO on Day 1.
10996690|NCT01033864|FG001|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
10996691|NCT01033864|OG000|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
10996692|NCT01033864|OG001|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
10996693|NCT01033864|EG000|Reported Event|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
10996694|NCT01033864|EG001|Reported Event|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
10996695|NCT01033942|BG000|Baseline|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996696|NCT01033942|BG001|Baseline|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996697|NCT01033942|BG002|Baseline|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996698|NCT01033942|BG003|Baseline|Total|Total of all reporting groups
10996699|NCT01033942|FG000|Participant Flow|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996700|NCT01033942|FG001|Participant Flow|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996701|NCT01033942|FG002|Participant Flow|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996702|NCT01033942|OG000|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996703|NCT01033942|OG001|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996704|NCT01033942|OG002|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996705|NCT01033942|OG002|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
10996706|NCT01033942|OG000|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996707|NCT01033942|EG000|Reported Event|FTC/TDC|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996708|NCT01033942|EG001|Reported Event|Placebo|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996709|NCT01033942|EG002|Reported Event|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
10996710|NCT01034111|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
10846571|NCT00278148|EG001|Reported Event|Dose Level B: 100 mg OSI-774/50 mg/m2|100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
10996711|NCT01034111|FG000|Participant Flow|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
10996712|NCT01034111|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
10996713|NCT01034111|EG000|Reported Event|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
10846572|NCT00278148|EG002|Reported Event|Dose Level C: 150 mg OSI-774/50 mg/m2|150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
10996714|NCT01034137|BG000|Baseline|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10-30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
10996715|NCT01034137|BG001|Baseline|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
10996716|NCT01034137|BG002|Baseline|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
10996717|NCT01034137|BG003|Baseline|Total|Total of all reporting groups
10996718|NCT01034137|FG000|Participant Flow|Tocilizumab + Methotrexate|Participants received intravenous (IV) Tocilizumab (TCZ) 8 milligram (mg)/kilogram (kg) every four weeks for a maximum of 26 infusions + oral capsules of Methotrexate (MTX) 10-30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
10996719|NCT01034137|FG001|Participant Flow|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
10996720|NCT01034137|FG002|Participant Flow|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
10996721|NCT01034137|OG000|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10-30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
10996722|NCT01034137|OG001|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
10996723|NCT01034137|OG002|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
10846573|NCT00278161|BG000|Baseline|R-HiCy|"Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.~Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.~Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.~Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18."
10996724|NCT01034137|OG002|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week
10996725|NCT01034137|EG000|Reported Event|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10-30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
10996726|NCT01034137|EG001|Reported Event|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
10996727|NCT01034137|EG002|Reported Event|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
10996728|NCT01034163|BG000|Baseline|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
10996729|NCT01034163|BG001|Baseline|Placebo|Participants received matching placebo to PAN TIW, QOW.
10996730|NCT01034163|BG002|Baseline|Total|Total of all reporting groups
10996731|NCT01034163|FG000|Participant Flow|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
10996732|NCT01034163|FG001|Participant Flow|Placebo|Participants received matching placebo to PAN TIW, QOW.
10996733|NCT01034163|OG000|Outcome|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
10996734|NCT01034163|OG001|Outcome|Placebo|Participants received matching placebo to PAN TIW, QOW.
10996735|NCT01034163|EG000|Reported Event|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
10996736|NCT01034163|EG001|Reported Event|Placebo|Participants received matching placebo to PAN TIW, QOW.
10996737|NCT01034176|BG000|Baseline|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
10996738|NCT01034176|BG001|Baseline|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
10996739|NCT01034176|BG002|Baseline|Total|Total of all reporting groups
10996740|NCT01034176|FG000|Participant Flow|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
10996741|NCT01034176|FG001|Participant Flow|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
10996742|NCT01034176|OG000|Outcome|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
10996743|NCT01034176|OG001|Outcome|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
10996744|NCT01034176|EG000|Reported Event|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
10996745|NCT01034176|EG001|Reported Event|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
10996746|NCT01034358|BG000|Baseline|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
10996747|NCT01034358|FG000|Participant Flow|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
10996748|NCT01034358|OG000|Outcome|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
10996749|NCT01034358|EG000|Reported Event|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
10996750|NCT01034397|BG000|Baseline|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
10996751|NCT01034397|BG001|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks.
10996752|NCT01034397|BG002|Baseline|Total|Total of all reporting groups
10996753|NCT01034397|FG000|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) intravenously (IV) once every 4 weeks for 24 weeks.
10996754|NCT01034397|FG001|Participant Flow|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of greater than or equal to [≥]20 percent [%] in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
10996755|NCT01034397|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
10996756|NCT01034397|OG001|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count [TJC] and swollen joint count [SJC]) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
10996757|NCT01034397|OG001|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
10996758|NCT01034397|OG001|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
11336457|NCT03566810|EG003|Reported Event|Reference GXR (Fed)|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/France) either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions.
10846574|NCT00278161|FG000|Participant Flow|R-HiCy|"Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.~Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.~Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.~Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18."
10846575|NCT00278161|OG000|Outcome|R-HiCy|"Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.~Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.~Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.~Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18."
10846576|NCT00278161|EG000|Reported Event|R-HiCy|"Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.~Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.~Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.~Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18."
10846577|NCT00278200|BG000|Baseline|EBV Seronegative|"Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.~Inactivated EBV-infected vaccine"
10846578|NCT00278200|BG001|Baseline|EBV Seropositive|"Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.~Inactivated EBV-infected vaccine"
10846579|NCT00278200|BG002|Baseline|Total|Total of all reporting groups
10846580|NCT00278200|FG000|Participant Flow|EBV Seronegative|Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
10846581|NCT00278200|FG001|Participant Flow|EBV Seropositive|Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
10846582|NCT00278200|OG000|Outcome|EBV Seronegative|"Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.~Inactivated EBV-infected vaccine"
10846583|NCT00278200|OG001|Outcome|EBV Seropositive|"Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.~Inactivated EBV-infected vaccine"
10846584|NCT00278200|EG000|Reported Event|EBV Seronegative|Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
10846585|NCT00278200|EG001|Reported Event|EBV Seropositive|Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
10846586|NCT00278395|BG000|Baseline|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
10846587|NCT00278395|FG000|Participant Flow|Vorinostat|The oral dose of vorinostat capsules was 300 mg two times a day for 3 consecutive days every week for 4 weeks, which constitutes on cycle of treatment. Treatment will be administered on an outpatient basis.
10846588|NCT00278395|OG000|Outcome|Vorinostat|The dose of Vorinostat was 300 mg BID on the first 3 days of every week on a 4-week cycle. Dose reduction was allowed for adverse events (AE). Treatment was planned until disease progression (PD), death, unacceptable toxicity, or consent withdrawal.
10846589|NCT00278395|OG000|Outcome|Progression Free Survival|No measurement reported
10846590|NCT00278395|OG000|Outcome|Overall Survival (OS) and Median OS|No measurement reported
10846591|NCT00278395|OG000|Outcome|Safety and Tolerability|No participants measured
10846592|NCT00278395|EG000|Reported Event|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
10846593|NCT00278473|BG000|Baseline|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
10846594|NCT00278473|BG001|Baseline|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
10846595|NCT00278473|BG002|Baseline|Total|Total of all reporting groups
10846596|NCT00278473|FG000|Participant Flow|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
10846597|NCT00278473|FG001|Participant Flow|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
10846598|NCT00278473|OG000|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
10846599|NCT00278473|OG001|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
10846600|NCT00278473|EG000|Reported Event|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
10846601|NCT00278473|EG001|Reported Event|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
10846602|NCT00278512|BG000|Baseline|Autologous Stem Cell Transplant|"Autologous Stem Cell Transplant will be performed on eligible patients~Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning"
10846603|NCT00278512|BG001|Baseline|Allogeneic Stem Cell Transplant|"Allogeneic Stem Cell Transplant will be performed on eligible patients~Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning"
10846604|NCT00278512|BG002|Baseline|Total|Total of all reporting groups
10846605|NCT00278512|FG000|Participant Flow|Autologous Stem Cell Transplant|"Autologous Stem Cell Transplant will be performed on eligible patients~Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning"
10996759|NCT01034397|OG002|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
10996760|NCT01034397|OG002|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for a 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
10996761|NCT01034397|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks
10996762|NCT01034397|OG001|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of at least 20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks.
10996763|NCT01034397|OG002|Outcome|Placebo-Tocilizumab|At 12 Weeks participants who did not show an improvement of ≥20% in tender and swollen joint counts were offered a rescue therapy with open-label tocilizumab 8mg/kg every 4 weeks
10996764|NCT01034397|OG002|Outcome|Placebo-Tocilizumab 8 mg/kg|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.
10996765|NCT01034397|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
10996766|NCT01034397|EG001|Reported Event|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
10996767|NCT01034397|EG002|Reported Event|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
10996768|NCT01034462|BG000|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
10996769|NCT01034462|BG001|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
10996770|NCT01034462|BG002|Baseline|Total|Total of all reporting groups
10996771|NCT01034462|FG000|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
10996772|NCT01034462|FG001|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
10996773|NCT01034462|OG000|Outcome|Placebo|"Matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo to be given orally, in capsule form, once daily, for 8 weeks."
10996774|NCT01034462|OG001|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks
10996775|NCT01034462|OG000|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
10996776|NCT01034462|OG001|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
10996777|NCT01034462|EG000|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
10996778|NCT01034462|EG001|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
10996779|NCT01034527|BG000|Baseline|Neuromuscular Training|"Combination of exercises and phases designed to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.~Neuromuscular Training: Combination of exercises and phases to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques."
10996780|NCT01034527|BG001|Baseline|Speed Training|Speed training protocol Sham training will consist of sagittal plane only running drills designs solely to enhance sprint speed. A sham sagittal plane sprint training protocol that will be instituted with the teams that are randomly selected for sham treatment. Five phases will be utilized to facilitate progressions designed to improve the athletes' forward sprinting speed. Training volume will be approximately equivalent for the TNMT and sham protocols. They each will take athletes approximately 30 minutes to complete
10996781|NCT01034527|BG002|Baseline|Total|Total of all reporting groups
10996782|NCT01034527|FG000|Participant Flow|Neuromuscular Training|"Combination of exercises and phases designed to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.~Neuromuscular Training: Combination of exercises and phases to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques."
10996783|NCT01034527|FG001|Participant Flow|Speed Training|Speed training protocol Sham training will consist of sagittal plane only running drills designs solely to enhance sprint speed. A sham sagittal plane sprint training protocol that will be instituted with the teams that are randomly selected for sham treatment. Five phases will be utilized to facilitate progressions designed to improve the athletes' forward sprinting speed. Training volume will be approximately equivalent for the TNMT and sham protocols. They each will take athletes approximately 30 minutes to complete
10996784|NCT01034527|OG000|Outcome|Neuromuscular Training|"Combination of exercises and phases designed to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.~Neuromuscular Training: Combination of exercises and phases to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques."
11336458|NCT03566823|BG000|Baseline|Placebo|Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10996785|NCT01034527|OG001|Outcome|Speed Training|Speed training protocol Sham training will consist of sagittal plane only running drills designs solely to enhance sprint speed. A sham sagittal plane sprint training protocol that will be instituted with the teams that are randomly selected for sham treatment. Five phases will be utilized to facilitate progressions designed to improve the athletes' forward sprinting speed. Training volume will be approximately equivalent for the TNMT and sham protocols. They each will take athletes approximately 30 minutes to complete
10996786|NCT01034527|EG000|Reported Event|Neuromuscular Training|"Combination of exercises and phases designed to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.~Neuromuscular Training: Combination of exercises and phases to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques."
10996787|NCT01034527|EG001|Reported Event|Speed Training|Speed training protocol Sham training will consist of sagittal plane only running drills designs solely to enhance sprint speed. A sham sagittal plane sprint training protocol that will be instituted with the teams that are randomly selected for sham treatment. Five phases will be utilized to facilitate progressions designed to improve the athletes' forward sprinting speed. Training volume will be approximately equivalent for the TNMT and sham protocols. They each will take athletes approximately 30 minutes to complete
10996788|NCT01034540|BG000|Baseline|Prescription Omega-3 Acid Ethyl Esters (POM3)/Placebo|POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
10996789|NCT01034540|BG001|Baseline|Placebo/Prescription Omega-3 Acid Ethyl Esters (POM3)|Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
10996790|NCT01034540|BG002|Baseline|Total|Total of all reporting groups
10996791|NCT01034540|FG000|Participant Flow|Prescription Omega-3 Acid Ethyl Esters/Placebo|Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the first six weeks of treatment. Placebo (corn oil 4 g/d) for the second six weeks of treatment
10996792|NCT01034540|FG001|Participant Flow|Placebo/Prescription Omega-3 Acid Ethyl Esters|Placebo (corn oil 4 g/d) for the first six weeks of treatment. Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the second six weeks of treatment
10996793|NCT01034540|OG000|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
10996794|NCT01034540|OG001|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
11223673|NCT02354690|OG000|Outcome|T Cell Therapy With Vemurafenib Pretreatment|"7 days before tumor harvest, patients will begin taking vemurafenib until admission for lymphodepleting chemotherapy followed by TIL infusion and interleukin-2.~Vemurafenib: Patients will start treatment in a dose of 960 BID 7 days before tumor harvest and ends at the day of admission (day -8).~Lymphodepleting chemotherapy regimen consisting of cyclophosphamide 60 mg/kg for 2 days and fludarabine 25 mg/m2 for 5 days (constitutes day -7 to -1 of admission).~TIL infusion: A tumor is surgically removed in order to isolate, activate and expand tumor infiltrating lymphocytes (TIL) to high numbers. In vitro preparation usually takes 4-6 weeks using the young TIL method.~On day 0 patients receive an infusion of TIL (1x10e9-2x10e11 cells).~Interleukin-2 is administered according to the decrescendo regimen (18 MIU/m2 for 6 hours, 18 MIU/m2 for 12 hours, 18 MIU/m2 for 24 hours followed by 4,5 MIU/m2 for another 3 x 24 hours)"
10996795|NCT01034540|OG000|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
10996796|NCT01034540|OG001|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
10996797|NCT01034540|EG000|Reported Event|POM3|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
10996798|NCT01034540|EG001|Reported Event|Placebo|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
10996799|NCT01034553|BG000|Baseline|All Patients|"All Patients that received oral aurora A kinase inhibitor MLN8237 and bortezomib IV are summarized in this section.~Aurora A kinase inhibitor MLN8237: Given orally"
10996800|NCT01034553|FG000|Participant Flow|Phase I, Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
10996801|NCT01034553|FG001|Participant Flow|Phase I, Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
10996802|NCT01034553|FG002|Participant Flow|Phase I, Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
10996803|NCT01034553|FG003|Participant Flow|Phase I, Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
10996804|NCT01034553|FG004|Participant Flow|Phase I, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
10996805|NCT01034553|FG005|Participant Flow|Phase II, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
10996806|NCT01034553|OG000|Outcome|Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
10996807|NCT01034553|OG001|Outcome|Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
10996808|NCT01034553|OG002|Outcome|Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
10996809|NCT01034553|OG003|Outcome|Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
10996810|NCT01034553|OG004|Outcome|Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
10996811|NCT01034553|OG000|Outcome|Dose Level 0|This includes patients who received 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11. As well as, patients who received 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
10996812|NCT01034553|OG001|Outcome|Dose Level 1|Patients received 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
10996813|NCT01034553|OG002|Outcome|Dose Level 2|Patients received 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
10996814|NCT01034553|OG003|Outcome|Dose Level 3|Patients received 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
10996815|NCT01034553|OG000|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
10996816|NCT01034553|OG000|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 and bortezomib IV. >~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
10996817|NCT01034553|EG000|Reported Event|All Patients|bortezomib: Given IV
10996818|NCT01034579|BG000|Baseline|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
10996819|NCT01034579|BG001|Baseline|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
10996820|NCT01034579|BG002|Baseline|Total|Total of all reporting groups
10996821|NCT01034579|FG000|Participant Flow|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
10996822|NCT01034579|FG001|Participant Flow|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
10996823|NCT01034579|OG000|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
11335401|NCT03549598|FG000|Participant Flow|68Ga-DOTATATE PET/CT|"68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject~68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.~18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.~13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol."
10996824|NCT01034579|OG001|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
10996825|NCT01034579|EG000|Reported Event|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
10996826|NCT01034579|EG001|Reported Event|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
10996827|NCT01034592|BG000|Baseline|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
10996828|NCT01034592|FG000|Participant Flow|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
10996829|NCT01034592|OG000|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
10996830|NCT01034592|OG000|Outcome|Lenalidomide|"Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.~Lenalidomide: 2.5 mg/wk up to 5 mg 3x/wk"
10846606|NCT00278512|FG001|Participant Flow|Allogeneic Stem Cell Transplant|"Allogeneic Stem Cell Transplant will be performed on eligible patients~Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning"
10996831|NCT01034592|EG000|Reported Event|Serious Adverse Events|Serious Adverse Events include: adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
10996832|NCT01034631|BG000|Baseline|Phase I Participants|Participants in the phase I dose escalation portion of the study.
10996833|NCT01034631|BG001|Baseline|Phase II: Arm A|"Phase II Participants, Arm A~Everolimus + BNC105P"
10996834|NCT01034631|BG002|Baseline|Phase II: Arm B Participants|"Phase II: Arm B Participants~Everolimus only, followed by BNC105P monotherapy"
10996835|NCT01034631|BG003|Baseline|Total|Total of all reporting groups
10996836|NCT01034631|FG000|Participant Flow|Phase I Participants|Participants in the phase I dose escalation portion of the study.
10996837|NCT01034631|FG001|Participant Flow|Phase II: Arm A|"Phase II Participants, Arm A~Everolimus 10mg + BNC105P(Phase I MTD)"
10996838|NCT01034631|FG002|Participant Flow|Phase II: Arm B Participants|"Phase II: Arm B Participants~Everolimus 10mg followed by BNC105P monotherapy (16mg/m^2) following progression or intolerable toxicity on Everolimus therapy."
10996839|NCT01034631|OG000|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
10996840|NCT01034631|OG000|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
10996841|NCT01034631|OG001|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
10996842|NCT01034631|OG000|Outcome|Arm B Participants Who Crossed Over to BNC105P Monotherapy|After progression on everolimus, 33 participants crossed over to BNC105P monotherapy per protocol.
10996843|NCT01034631|OG000|Outcome|Phase II Participants With Sufficient Correlative Samples|A subset of Phase II Participants who had sufficient correlative samples drawn for plasma biomarker analysis.
10996844|NCT01034631|EG000|Reported Event|Phase I Participants|Participants in the phase I dose escalation portion of the study.
10996845|NCT01034631|EG001|Reported Event|Phase II: Arm A|Phase II Participants, Arm A
10996846|NCT01034631|EG002|Reported Event|Phase II: Arm B Participants|Phase II: Arm B Participants
11223674|NCT02354690|EG000|Reported Event|T Cell Therapy With Vemurafenib Pretreatment|"7 days before tumor harvest, patients will begin taking vemurafenib until admission for lymphodepleting chemotherapy followed by TIL infusion and interleukin-2.~Vemurafenib: Patients will start treatment in a dose of 960 BID 7 days before tumor harvest and ends at the day of admission (day -8).~Lymphodepleting chemotherapy regimen consisting of cyclophosphamide 60 mg/kg for 2 days and fludarabine 25 mg/m2 for 5 days (constitutes day -7 to -1 of admission).~TIL infusion: A tumor is surgically removed in order to isolate, activate and expand tumor infiltrating lymphocytes (TIL) to high numbers. In vitro preparation usually takes 4-6 weeks using the young TIL method.~On day 0 patients receive an infusion of TIL (1x10e9-2x10e11 cells).~Interleukin-2 is administered according to the decrescendo regimen (18 MIU/m2 for 6 hours, 18 MIU/m2 for 12 hours, 18 MIU/m2 for 24 hours followed by 4,5 MIU/m2 for another 3 x 24 hours)"
11223675|NCT02354781|BG000|Baseline|Dose Group 1|Participants enrolled will receive a single dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344 delivered to the lower limbs
11223676|NCT02354781|FG000|Participant Flow|2.4E12 vg/kg CMV.huFollistatin344|Participants enrolled will receive a single dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344 delivered to the lower limbs
10996847|NCT01034657|BG000|Baseline|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
10996848|NCT01034657|FG000|Participant Flow|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
10996849|NCT01034657|FG001|Participant Flow|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
10996850|NCT01034657|FG002|Participant Flow|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
10996851|NCT01034657|OG000|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
10996852|NCT01034657|OG001|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
10996853|NCT01034657|OG002|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
10996854|NCT01034657|OG002|Outcome|Not Randomized|
10996855|NCT01034657|EG000|Reported Event|LBH589 - Core Phase|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
10996856|NCT01034657|EG001|Reported Event|LBH589 - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
10996857|NCT01034657|EG002|Reported Event|LBH589 + ESA - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
10996858|NCT01034657|EG003|Reported Event|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
10996859|NCT01034709|BG000|Baseline|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
10996860|NCT01034709|BG001|Baseline|Asymptomatic|Subjects who are serologically negative for CMV IgG
10996861|NCT01034709|BG002|Baseline|Total|Total of all reporting groups
10996862|NCT01034709|FG000|Participant Flow|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
10996863|NCT01034709|FG001|Participant Flow|Asymptomatic|Subjects who are serologically negative for CMV IgG prior to transplantation and do not have any CMV symptoms
10996864|NCT01034709|OG000|Outcome|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
10996865|NCT01034709|OG001|Outcome|Asymptomatic|Subjects who are serologically negative for CMV IgG
10996866|NCT01034709|EG000|Reported Event|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
10996867|NCT01034709|EG001|Reported Event|Asymptomatic|Subjects who are serologically negative for CMV IgG
10996868|NCT01035047|BG000|Baseline|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
10996869|NCT01035047|BG001|Baseline|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
10996870|NCT01035047|BG002|Baseline|Total|Total of all reporting groups
10996871|NCT01035047|FG000|Participant Flow|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
10996872|NCT01035047|FG001|Participant Flow|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
10996873|NCT01035047|OG000|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
10996874|NCT01035047|OG001|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
10996875|NCT01035047|EG000|Reported Event|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
10996876|NCT01035047|EG001|Reported Event|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
10996877|NCT01035060|BG000|Baseline|Older Adults|
10996878|NCT01035060|BG001|Baseline|Young Adults|
10996879|NCT01035060|BG002|Baseline|Total|Total of all reporting groups
10996880|NCT01035060|FG000|Participant Flow|Older Adults|Persons aged ≥ 70 years
10996881|NCT01035060|FG001|Participant Flow|Young Adults|Persons aged 18-30 years
10996882|NCT01035060|OG000|Outcome|Older Adults|Age > 70 years
10996883|NCT01035060|OG001|Outcome|Young Adults|Age 18-35 years
10996884|NCT01035060|EG000|Reported Event|Younger Adults|
10996885|NCT01035060|EG001|Reported Event|Older Adults|
10996886|NCT01035099|BG000|Baseline|Titrated Dose Letrozole|"Patients who are randomized to the titrated dose of Letrozole, will start gonadotropins in the evening of day #2 of their menstrual cycle with injectable follicle stimulating hormone (FSH) and human menopausal gonadotropin (HMG). Oral Letrozole will be added to the stimulation in the following titrated regimen.~Letrozole: Letrozole titrated regimen may be started on day 2 of menstrual cycle:~Serum Estradiol level <150 pg/ml- No Letrozole; Serum Estradiol Level 150-250 pg/ml- 2.5mg; Serum Estradiol Level 251-350 pg/ml- 5 mg; Serum Estradiol Level >350 pg/ml - 7.5 mg;"
10996887|NCT01035099|BG001|Baseline|Fixed Dose Letrozole|"Patients who are randomized to fixed dose Letrozole will start Letrozole 5mg daily (orally) on the second day of their menstrual cycle and then gonadotropins on the fourth day of their menstrual cycle.~Letrozole: Fixed dose of 5 mg per day Letrozole will be started on the second day of their menstrual cycle."
10996888|NCT01035099|BG002|Baseline|Total|Total of all reporting groups
10996889|NCT01035099|FG000|Participant Flow|Titrated Dose Letrozole|"Patients who are randomized to the titrated dose of Letrozole, will start gonadotropins in the evening of day #2 of their menstrual cycle with injectable follicle stimulating hormone (FSH) and human menopausal gonadotropin (HMG). Oral Letrozole will be added to the stimulation in the following titrated regimen.~Letrozole: Letrozole titrated regimen may be started on day 2 of menstrual cycle:~Serum Estradiol level <150 pg/ml- No Letrozole; Serum Estradiol Level 150-250 pg/ml- 2.5mg; Serum Estradiol Level 251-350 pg/ml- 5 mg; Serum Estradiol Level >350 pg/ml - 7.5 mg;"
11223677|NCT02354781|OG000|Outcome|2.4E12 vg/kg CMV.huFollistatin344|Participants enrolled who receive a total dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344.
10996890|NCT01035099|FG001|Participant Flow|Fixed Dose Letrozole|"Patients who are randomized to fixed dose Letrozole will start Letrozole 5mg daily (orally) on the second day of their menstrual cycle and then gonadotropins on the fourth day of their menstrual cycle.~Letrozole: Fixed dose of 5 mg per day Letrozole will be started on the second day of their menstrual cycle."
10996891|NCT01035099|OG000|Outcome|Titrated Dose Letrozole|"Patients who are randomized to the titrated dose of Letrozole, will start gonadotropins in the evening of day #2 of their menstrual cycle with injectable follicle stimulating hormone (FSH) and human menopausal gonadotropin (HMG). Oral Letrozole will be added to the stimulation in the following titrated regimen.~Letrozole: Letrozole titrated regimen may be started on day 2 of menstrual cycle:~Serum Estradiol level <150 pg/ml- No Letrozole; Serum Estradiol Level 150-250 pg/ml- 2.5mg; Serum Estradiol Level 251-350 pg/ml- 5 mg; Serum Estradiol Level >350 pg/ml - 7.5 mg;"
10996892|NCT01035099|OG001|Outcome|Fixed Dose Letrozole|"Patients who are randomized to fixed dose Letrozole will start Letrozole 5mg daily (orally) on the second day of their menstrual cycle and then gonadotropins on the fourth day of their menstrual cycle.~Letrozole: Fixed dose of 5 mg per day Letrozole will be started on the second day of their menstrual cycle."
10996893|NCT01035099|OG001|Outcome|Fixed Dose Letrozole|"Patients who are randomized to fixed dose Letrozole will start Letrozole 5mg daily (orally) on the second day of their menstrual cycle and then gonadotropins on the fourth day of their menstrual cycle.~Letrozole: Fixed dose of 5 mg per day Letrozole will be started on the second day of their menstrual cycle"
10996894|NCT01035099|EG000|Reported Event|Titrated Dose Letrozole|"Patients who are randomized to the titrated dose of Letrozole, will start gonadotropins in the evening of day #2 of their menstrual cycle with injectable follicle stimulating hormone (FSH) and human menopausal gonadotropin (HMG). Oral Letrozole will be added to the stimulation in the following titrated regimen.~Letrozole: Letrozole titrated regimen may be started on day 2 of menstrual cycle:~Serum Estradiol level <150 pg/ml- No Letrozole; Serum Estradiol Level 150-250 pg/ml- 2.5mg; Serum Estradiol Level 251-350 pg/ml- 5 mg; Serum Estradiol Level >350 pg/ml - 7.5 mg;"
10996895|NCT01035099|EG001|Reported Event|Fixed Dose Letrozole|"Patients who are randomized to fixed dose Letrozole will start Letrozole 5mg daily (orally) on the second day of their menstrual cycle and then gonadotropins on the fourth day of their menstrual cycle.~Letrozole: Fixed dose of 5 mg per day Letrozole will be started on the second day of their menstrual cycle."
10996896|NCT01035138|BG000|Baseline|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
10996897|NCT01035138|BG001|Baseline|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
10996898|NCT01035138|BG002|Baseline|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
10996899|NCT01035138|BG003|Baseline|Total|Total of all reporting groups
10996900|NCT01035138|FG000|Participant Flow|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 milligram (mg) orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
10996901|NCT01035138|FG001|Participant Flow|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 (LY 100 mg) orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
10996902|NCT01035138|FG002|Participant Flow|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
10996903|NCT01035138|OG000|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
10996904|NCT01035138|OG001|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
10996905|NCT01035138|OG002|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
10996906|NCT01035138|OG000|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
10996907|NCT01035138|OG000|Outcome|LY 140 mg|Participants received 140 mg LY450319 orally once daily up to 24 months during extension study (LFBF)
10996908|NCT01035138|EG000|Reported Event|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
10996909|NCT01035138|EG001|Reported Event|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
10996910|NCT01035138|EG002|Reported Event|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
10996911|NCT01035151|BG000|Baseline|Delayed Control|"Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.~Control: Written Cessation Materials"
11223678|NCT02354781|OG000|Outcome|2.4E12 vg/kg CMV.huFollistatin344|Participants enrolled will receive a total dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344 delivered to the lower limbs
10996912|NCT01035151|BG001|Baseline|Experimental|"Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities~Experimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)"
10996913|NCT01035151|BG002|Baseline|Total|Total of all reporting groups
10996914|NCT01035151|FG000|Participant Flow|Delayed Control|"Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.~Control: Written Cessation Materials"
10996915|NCT01035151|FG001|Participant Flow|Experimental|"Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities~Experimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)"
10996916|NCT01035151|OG000|Outcome|Delayed Control|"Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.~Control: Written Cessation Materials"
10996917|NCT01035151|OG001|Outcome|Experimental|"Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities~Experimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)"
10996918|NCT01035151|EG000|Reported Event|Delayed Control|"Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.~Control: Written Cessation Materials"
10996919|NCT01035151|EG001|Reported Event|Experimental|"Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities~Experimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)"
10996920|NCT01035229|BG000|Baseline|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
10996921|NCT01035229|BG001|Baseline|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
10996922|NCT01035229|BG002|Baseline|Total|Total of all reporting groups
10846607|NCT00278512|OG000|Outcome|Autologous Stem Cell Transplant|"Autologous Stem Cell Transplant will be performed on eligible patients~Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning"
10996923|NCT01035229|FG000|Participant Flow|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
10996924|NCT01035229|FG001|Participant Flow|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
10996925|NCT01035229|OG000|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
10996926|NCT01035229|OG001|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
10996927|NCT01035229|OG000|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
10996928|NCT01035229|OG001|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
10996929|NCT01035229|EG000|Reported Event|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
10996930|NCT01035229|EG001|Reported Event|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
10996931|NCT01035255|BG000|Baseline|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
10996932|NCT01035255|BG001|Baseline|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
10996933|NCT01035255|BG002|Baseline|Total|Total of all reporting groups
10996934|NCT01035255|FG000|Participant Flow|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
10996935|NCT01035255|FG001|Participant Flow|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
10996936|NCT01035255|OG000|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
10996937|NCT01035255|OG001|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
10996938|NCT01035255|EG000|Reported Event|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
10996939|NCT01035255|EG001|Reported Event|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
10996940|NCT01035333|BG000|Baseline|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
10996941|NCT01035333|FG000|Participant Flow|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
10996942|NCT01035333|OG000|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
10996943|NCT01035333|EG000|Reported Event|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
10996944|NCT01035346|BG000|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
10996945|NCT01035346|BG001|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
10996946|NCT01035346|BG002|Baseline|Total|Total of all reporting groups
10996947|NCT01035346|FG000|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
10996948|NCT01035346|FG001|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
10996949|NCT01035346|OG000|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
10996950|NCT01035346|OG001|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
10996951|NCT01035346|EG000|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
10996952|NCT01035346|EG001|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
10996953|NCT01035463|BG000|Baseline|All Phase I Participants|AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION
10996954|NCT01035463|BG001|Baseline|All Phase II Participants|AUTOLOGOUS HEMATOPOIETIC STEM CELL
10996955|NCT01035463|BG002|Baseline|Total|Total of all reporting groups
10996956|NCT01035463|FG000|Participant Flow|Phase I - 10 mg Len|"AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0.~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996957|NCT01035463|FG001|Participant Flow|Phase 1 - 15 mg Len|"AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0.~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996958|NCT01035463|FG002|Participant Flow|Phase 1 - 20 mg Len|"AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0.~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996959|NCT01035463|FG003|Participant Flow|Phase 1 - 25mg Len|"AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0.~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996960|NCT01035463|FG004|Participant Flow|Phase II - 15 mg Len|Based in Phase I data, the MTD was determined to be 15 mg but, the MTD for the study was based on cycle 1 of the Lenalidomide maintenance. However, there is cumulative toxicity of Lenalidomide, especially in the post-transplant setting which led to a need to lower the dose to 10 mg for the Phase II study. At the 10 mg dose, a much higher percentage of subjects were able to complete > 6 months of maintenance therapy. Therefore the dose for continued Phase II will be 10 mg.
10996961|NCT01035463|FG005|Participant Flow|Phase II - 10 mg Len|Based in Phase I data, the MTD was determined to be 15 mg but, the MTD for the study was based on cycle 1 of the Lenalidomide maintenance. However, there is cumulative toxicity of Lenalidomide, especially in the post-transplant setting which led to a need to lower the dose to 10 mg for the Phase II study. At the 10 mg dose, a much higher percentage of subjects were able to complete > 6 months of maintenance therapy. Therefore the dose for continued Phase II will be 10 mg.
10996962|NCT01035463|OG000|Outcome|Treatment (Stem Cell Transplantation)|"Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996963|NCT01035463|OG000|Outcome|All Phase I Participants|"Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996964|NCT01035463|OG001|Outcome|All Phase II Participants|"Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996965|NCT01035463|EG000|Reported Event|All Phase I Participants|"Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996966|NCT01035463|EG001|Reported Event|All Phase II Participants|"Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION~MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity."
10996967|NCT01035606|BG000|Baseline|Goal-oriented Attention Regulation Training|"training in goal-directed attention regulation~training in goal-directed attention regulation: training in goal-directed attention regulation"
10996968|NCT01035606|BG001|Baseline|Education|"brain health education~brain health education: brain health education workshops"
10996969|NCT01035606|BG002|Baseline|Technology-assisted Goal-directed Self-Regulation Training|"computer-assisted training in goal-directed attention regulation~computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills"
10996970|NCT01035606|BG003|Baseline|Total|Total of all reporting groups
10996971|NCT01035606|FG000|Participant Flow|Goal-oriented Attention Regulation Training|Therapist-guided training in goal-oriented attention regulation in a group format
10996972|NCT01035606|FG001|Participant Flow|Education|"brain health education~brain health education: brain health education workshops"
10996973|NCT01035606|FG002|Participant Flow|Technology-assisted Goal-directed Self-Regulation Training|computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
10996974|NCT01035606|OG000|Outcome|Goal-oriented Attention Regulation Training|"Training in goal-directed attention regulation~Training in goal-directed attention regulation: training in goal-directed attention regulation"
10996975|NCT01035606|OG001|Outcome|Education|"brain health education~brain health education: brain health education workshops"
10996976|NCT01035606|OG002|Outcome|Technology-assisted Goal-directed Self-Regulation Training|"computer-assisted training in goal-directed attention regulation~computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills"
10996977|NCT01035606|EG000|Reported Event|Goal-oriented Attention Regulation Training|"training in goal-directed attention regulation~training in goal-directed attention regulation: training in goal-directed attention regulation"
11223679|NCT02354781|EG000|Reported Event|2.4E12 vg/kg (1.2E12vg/kg/Limb) of rAAV1.CMV.huFollistatin344|Participants enrolled will receive a total dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344 delivered to the lower limbs
11223680|NCT02354833|BG000|Baseline|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
11223681|NCT02354833|BG001|Baseline|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
11223682|NCT02354833|BG002|Baseline|Total|Total of all reporting groups
11223683|NCT02354833|FG000|Participant Flow|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
11223684|NCT02354833|FG001|Participant Flow|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
11223685|NCT02354833|OG000|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
11223686|NCT02354833|OG001|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
11223687|NCT02354833|OG000|Outcome|Phenylephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
11223688|NCT02354833|OG001|Outcome|Norepinephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
11223689|NCT02354833|EG000|Reported Event|Phenylephrine|Hypotension requiring a rescue bolus
11223690|NCT02354833|EG001|Reported Event|Norepinephrine|Hypotension requiring a rescue bolus
11223691|NCT02354859|BG000|Baseline|Gallium|"Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days.~Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate."
10846608|NCT00278512|OG001|Outcome|Allogeneic Stem Cell Transplant|"Allogeneic Stem Cell Transplant will be performed on eligible patients~Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning"
10846609|NCT00278512|EG000|Reported Event|Autologous Stem Cell Transplant|"Autologous Stem Cell Transplant will be performed on eligible patients~Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning"
10846610|NCT00278512|EG001|Reported Event|Allogeneic Stem Cell Transplant|"Allogeneic Stem Cell Transplant will be performed on eligible patients~Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning"
10846611|NCT00278525|BG000|Baseline|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
10846612|NCT00278525|BG001|Baseline|Standard of Care|medication as standard of care will be given
10996978|NCT01035606|EG001|Reported Event|Education|"brain health education~brain health education: brain health education workshops"
11223692|NCT02354859|BG001|Baseline|Placebo|"Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga~Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate."
11223693|NCT02354859|BG002|Baseline|Total|Total of all reporting groups
11223694|NCT02354859|FG000|Participant Flow|Gallium|"Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days.~Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate."
10846613|NCT00278525|BG002|Baseline|Total|Total of all reporting groups
10846614|NCT00278525|FG000|Participant Flow|Standard of Care|Cyclophosphamide will be given as approved immunosuppressive therapy
11223695|NCT02354859|FG001|Participant Flow|Placebo|"Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga~Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate."
11223696|NCT02354859|OG000|Outcome|Gallium|"Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days.~Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate."
11223697|NCT02354859|OG001|Outcome|Placebo|"Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga~Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate."
11223698|NCT02354859|EG000|Reported Event|Gallium|"Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days.~Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate."
10846615|NCT00278525|FG001|Participant Flow|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
10846616|NCT00278525|OG000|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
10846617|NCT00278525|OG001|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
10846618|NCT00278525|EG000|Reported Event|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
10846619|NCT00278525|EG001|Reported Event|Standard of Care|medication as standard of care will be given
10846620|NCT00278538|BG000|Baseline|Hematopoietic Stem Cell Transplantation|"Autologous hematopoietic stem cell transplantation will be performed~Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation"
10846621|NCT00278538|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|"Autologous hematopoietic stem cell transplantation will be performed~Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation"
10846622|NCT00278538|OG000|Outcome|Hematopoietic Stem Cell Transplantation|"Autologous hematopoietic stem cell transplantation will be performed~Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation"
10996979|NCT01035606|EG002|Reported Event|Technology-assisted Goal-directed Self-Regulation Training|"computer-assisted training in goal-directed attention regulation~computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills"
10996980|NCT01035658|BG000|Baseline|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996981|NCT01035658|BG001|Baseline|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996982|NCT01035658|BG002|Baseline|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996983|NCT01035658|BG003|Baseline|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996984|NCT01035658|BG004|Baseline|Total|Total of all reporting groups
10996985|NCT01035658|FG000|Participant Flow|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996986|NCT01035658|FG001|Participant Flow|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996987|NCT01035658|FG002|Participant Flow|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996988|NCT01035658|FG003|Participant Flow|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996989|NCT01035658|OG000|Outcome|Phase 1|All patients in Phase I (this section contains the Maximum Tolerated Dose)
10996990|NCT01035658|OG000|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996991|NCT01035658|OG001|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
11223699|NCT02354859|EG001|Reported Event|Placebo|"Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga~Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate."
10846623|NCT00278538|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|"Autologous hematopoietic stem cell transplantation will be performed~Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation"
10996992|NCT01035658|OG002|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996993|NCT01035658|OG003|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996994|NCT01035658|OG000|Outcome|Platinum Refractory Disease|Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
10996995|NCT01035658|OG001|Outcome|Platinum Sensitive Disease|Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
10996996|NCT01035658|EG000|Reported Event|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996997|NCT01035658|EG001|Reported Event|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996998|NCT01035658|EG002|Reported Event|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10996999|NCT01035658|EG003|Reported Event|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
10997000|NCT01035749|BG000|Baseline|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997001|NCT01035749|BG001|Baseline|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
11223700|NCT02354924|BG000|Baseline|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
10997002|NCT01035749|BG002|Baseline|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
10997003|NCT01035749|BG003|Baseline|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997004|NCT01035749|BG004|Baseline|Total|Total of all reporting groups
10997005|NCT01035749|FG000|Participant Flow|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997006|NCT01035749|FG001|Participant Flow|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997007|NCT01035749|FG002|Participant Flow|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
10997008|NCT01035749|FG003|Participant Flow|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997009|NCT01035749|OG000|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997010|NCT01035749|OG001|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997011|NCT01035749|OG002|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
10877652|NCT00448357|OG000|Outcome|Experimental: GVHD Prophylaxis|"Matched related donor (MRD) subjects receive Graft Vs Host Disease (GVHD )prophylaxis with Methotrexate alone Subjects also receive busulfan, fludarabine, and tacrolimus and may receive Alemtuzumab.~Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
10877653|NCT00448357|OG000|Outcome|Low Busulfan AUC Tertile (5078)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
10877654|NCT00448357|OG001|Outcome|Intermediate Busulfan AUC Tertile (6372)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
10877655|NCT00448357|OG002|Outcome|High Busulfan AUC Tertile (7605)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
10877656|NCT00448357|EG000|Reported Event|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis~Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .~Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
10877657|NCT00448435|BG000|Baseline|Overall Study Population|Randomized Population
10877658|NCT00448435|FG000|Participant Flow|SFC 50/100 Mcg/Day First|GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period).
10877659|NCT00448435|FG001|Participant Flow|SLM 50 Mcg + FP 100 Mcg/Day First|SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period).
10877660|NCT00448435|OG000|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
11099071|NCT01579565|BG001|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11099072|NCT01579565|BG002|Baseline|Total|Total of all reporting groups
11223701|NCT02354924|BG001|Baseline|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
11223702|NCT02354924|BG002|Baseline|Total|Total of all reporting groups
11223703|NCT02354924|FG000|Participant Flow|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
11336459|NCT03566823|BG001|Baseline|Ontamalimab 25 mg|Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10877661|NCT00448435|OG001|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
10877662|NCT00448435|OG001|Outcome|SLM 50mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily
10877663|NCT00448435|OG000|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
10877664|NCT00448435|EG000|Reported Event|SFC 50/100 Mcg/Day|Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
10877665|NCT00448435|EG001|Reported Event|SLM 50 + FP 100 Mcg/Day|Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
10877666|NCT00448435|EG002|Reported Event|SFC 50/100mcg/Day (Extension Period)|Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period
10877667|NCT00448448|BG000|Baseline|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Brace: Brace (TLSO) prescribed for at least 18 hours per day. Wear time measured using a temperature monitor. Orthotic evaluations are conducted every 6 months and as necessary to maintain brace fit and function."
10877668|NCT00448448|BG001|Baseline|Observation|Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
10877669|NCT00448448|BG002|Baseline|Total|Total of all reporting groups
10877670|NCT00448448|FG000|Participant Flow|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
10877671|NCT00448448|FG001|Participant Flow|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
11223704|NCT02354924|FG001|Participant Flow|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
10877672|NCT00448448|OG000|Outcome|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
10877673|NCT00448448|OG001|Outcome|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
10877674|NCT00448448|EG000|Reported Event|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
10877675|NCT00448448|EG001|Reported Event|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
10877676|NCT00448539|BG000|Baseline|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
10997012|NCT01035749|OG003|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10877677|NCT00448539|BG001|Baseline|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
10877678|NCT00448539|BG002|Baseline|Total|Total of all reporting groups
10877679|NCT00448539|FG000|Participant Flow|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 milligram per day (mg/day) achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
10877680|NCT00448539|FG001|Participant Flow|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
10877681|NCT00448539|OG000|Outcome|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
10877682|NCT00448539|OG001|Outcome|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
10879500|NCT00458237|FG000|Participant Flow|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10877683|NCT00448539|EG000|Reported Event|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
10877684|NCT00448539|EG001|Reported Event|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
10877685|NCT00448591|BG000|Baseline|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
10877686|NCT00448591|FG000|Participant Flow|Bevacizumab|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy or in combination with other chemotherapy as prescribed.
10877687|NCT00448591|OG000|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
10877688|NCT00448591|OG000|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
10877689|NCT00448591|OG000|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
10877690|NCT00448591|EG000|Reported Event|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
10877691|NCT00448669|BG000|Baseline|TDF-FTC, Condoms, Risk Counseling|"Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC."
10877692|NCT00448669|BG001|Baseline|Placebo, Condoms, Risk Counseling|"Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~TDF-FTC placebo: Placebo comparator for TDF-FTC"
10877693|NCT00448669|BG002|Baseline|Total|Total of all reporting groups
10877694|NCT00448669|FG000|Participant Flow|TDF-FTC, Condoms, Risk Counseling|"Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC."
10877695|NCT00448669|FG001|Participant Flow|Placebo, Condoms, Risk Counseling|"Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~TDF-FTC placebo: Placebo comparator for TDF-FTC"
10877696|NCT00448669|OG000|Outcome|TDF-FTC, Condoms, Risk Counseling|"Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC."
10877697|NCT00448669|OG001|Outcome|Placebo, Condoms, Risk Counseling|"Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~TDF-FTC placebo: Placebo comparator for TDF-FTC"
10877698|NCT00448669|OG000|Outcome|TDF-FTC Seroconvertor Group|Participants who were assigned to receive TDF-FTC and seroconverted.
10877699|NCT00448669|OG001|Outcome|Placebo Seroconvertor Group|Participants who were assigned to receive the placebo and seroconverted.
10877700|NCT00448669|EG000|Reported Event|TDF-FTC, Condoms, Risk Counseling|"Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC."
10877701|NCT00448669|EG001|Reported Event|Placebo, Condoms, Risk Counseling|"Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~TDF-FTC placebo: Placebo comparator for TDF-FTC"
10997013|NCT01035749|EG000|Reported Event|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997014|NCT01035749|EG001|Reported Event|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997015|NCT01035749|EG002|Reported Event|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
10997016|NCT01035749|EG003|Reported Event|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
10997017|NCT01035788|BG000|Baseline|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD: This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive behavioral conjoint therapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
10997018|NCT01035788|BG001|Baseline|Cognitive Behavioral Conjoint Therapy Communication Skills|"Psychoeducational Intervention~Psychoeducation (control): This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD."
10997019|NCT01035788|BG002|Baseline|Total|Total of all reporting groups
10997020|NCT01035788|FG000|Participant Flow|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy for PTSD (MB-CBCT) is an adaptation of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT) that offers CBCT Phases 1 and 2 plus mindfulness training in a couple weekend retreat format, followed by continued use of mindfulness skills in session and for out of session practice during one transition couple therapy session, followed by CBCT Phase 3 couple sessions.
10997021|NCT01035788|FG001|Participant Flow|Cognitive Behavioral Conjoint Therapy Communication Skills|Cognitive-Behavioral Conjoint Therapy (CBCT) phases 1-2 communications skills training (no PTSD psychoeducation) offered during a weekend couple retreat followed by two monthly group couple sessions for skills review.
10997022|NCT01035788|OG000|Outcome|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive Behavioral ConjointTtherapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
10997023|NCT01035788|OG001|Outcome|Cognitive Behavioral Conjoint Therapy Communication Skills|"Cognitive-Behavioral Conjoint Therapy for PTSD - Communication Skills~This control intervention will provide communication skills training from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
10997024|NCT01035788|EG000|Reported Event|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~Mindfulness Based Cognitive Behavioral Conjoint Therapy: This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
10997025|NCT01035788|EG001|Reported Event|Cognitive Behavioral Conjoint Therapy Communication Skills|"CBCT for PTSD - Communication Skills~CBCT for PTSD - Communication Skills: This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
10997026|NCT01035905|BG000|Baseline|Nelfilcon A|Nelfilcon A contact lens
10997027|NCT01035905|BG001|Baseline|Narafilcon A|Narafilcon A contact lens
10997028|NCT01035905|BG002|Baseline|Total|Total of all reporting groups
10997029|NCT01035905|FG000|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
10997030|NCT01035905|FG001|Participant Flow|Narafilcon A|Narafilcon A contact lens
10997031|NCT01035905|OG000|Outcome|Nelfilcon A|Nelfilcon A contact lens
10997032|NCT01035905|OG001|Outcome|Narafilcon A|Narafilcon A contact lens
10997033|NCT01035905|EG000|Reported Event|Nelfilcon A|Nelfilcon A contact lens
10997034|NCT01035905|EG001|Reported Event|Narafilcon A|Narafilcon A contact lens
10997035|NCT01036009|BG000|Baseline|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
10997036|NCT01036009|BG001|Baseline|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
10997037|NCT01036009|BG002|Baseline|Total|Total of all reporting groups
10997038|NCT01036009|FG000|Participant Flow|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
10997039|NCT01036009|FG001|Participant Flow|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
10997040|NCT01036009|OG000|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
10997041|NCT01036009|OG001|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
10997042|NCT01036009|OG000|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
10997043|NCT01036009|EG000|Reported Event|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
10997044|NCT01036009|EG001|Reported Event|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
10997045|NCT01036022|BG000|Baseline|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997046|NCT01036022|BG001|Baseline|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997047|NCT01036022|BG002|Baseline|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997048|NCT01036022|BG003|Baseline|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997049|NCT01036022|BG004|Baseline|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997050|NCT01036022|BG005|Baseline|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997051|NCT01036022|BG006|Baseline|Total|Total of all reporting groups
10997052|NCT01036022|FG000|Participant Flow|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules three times a day (TID) as directed by the investigator for Week 1 to Week 6. Topical 5-aminosalicylic acid (5-ASA) preparation was used as a rescue therapy.
11223705|NCT02354924|OG000|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
11223706|NCT02354924|OG001|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
10997053|NCT01036022|FG001|Participant Flow|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997054|NCT01036022|FG002|Participant Flow|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997055|NCT01036022|FG003|Participant Flow|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997056|NCT01036022|FG004|Participant Flow|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997057|NCT01036022|FG005|Participant Flow|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997058|NCT01036022|OG000|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997059|NCT01036022|OG001|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997060|NCT01036022|OG002|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997061|NCT01036022|OG003|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997062|NCT01036022|OG004|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997063|NCT01036022|OG005|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997064|NCT01036022|OG000|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997065|NCT01036022|OG001|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997066|NCT01036022|OG002|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997067|NCT01036022|OG003|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997068|NCT01036022|OG000|Outcome|GSK1399686 10mg|Participants were administered oral dose of GSK1399686 10 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 10 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997069|NCT01036022|OG001|Outcome|GSK1399686 30mg|Participants were administered oral dose of GSK1399686 30 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 30 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997070|NCT01036022|OG002|Outcome|GSK1399686 100mg|Participants were administered oral dose of GSK1399686 100 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 100 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997071|NCT01036022|OG003|Outcome|GSK1399686 300mg|Participants were administered oral dose of GSK1399686 300 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 300 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997072|NCT01036022|EG000|Reported Event|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997073|NCT01036022|EG001|Reported Event|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997074|NCT01036022|EG002|Reported Event|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997075|NCT01036022|EG003|Reported Event|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997076|NCT01036022|EG004|Reported Event|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997077|NCT01036022|EG005|Reported Event|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
10997078|NCT01036165|BG000|Baseline|Subject Disposition|Intent-to-Treat Analysis
10997079|NCT01036165|FG000|Participant Flow|Subject Disposition|Intent-to-Treat Analysis
10997080|NCT01036165|OG000|Outcome|Subject Disposition|Intent-to-Treat Analysis
10997081|NCT01036165|EG000|Reported Event|Subject Disposition|Intent-to-Treat Analysis
10997082|NCT01036321|BG000|Baseline|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
10997083|NCT01036321|BG001|Baseline|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
10997084|NCT01036321|BG002|Baseline|Total|Total of all reporting groups
10997085|NCT01036321|FG000|Participant Flow|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
10997086|NCT01036321|FG001|Participant Flow|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
10997087|NCT01036321|OG000|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
10997088|NCT01036321|OG001|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
10997089|NCT01036321|EG000|Reported Event|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
10997090|NCT01036321|EG001|Reported Event|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
11223707|NCT02354924|OG000|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
11223708|NCT02354924|OG001|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
11223709|NCT02354924|EG000|Reported Event|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
11223710|NCT02354924|EG001|Reported Event|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
11223711|NCT02354976|BG000|Baseline|Epanova|Epanova 4 g/day + placebo to Fenofibrate
11223712|NCT02354976|BG001|Baseline|Fenofibrate|Fenofibrate 200 mg/ day + placebo to Epanova
11223713|NCT02354976|BG002|Baseline|Placebo|Placebo to Epanova + placebo to Fenofibrate
11223714|NCT02354976|BG003|Baseline|Total|Total of all reporting groups
11223715|NCT02354976|FG000|Participant Flow|Epanova|Epanova 4 g/day + placebo to Fenofibrate
11223716|NCT02354976|FG001|Participant Flow|Fenofibrate|Fenofibrate 200 mg/ day + placebo to Epanova
11223717|NCT02354976|FG002|Participant Flow|Placebo|Placebo to Epanova + placebo to Fenofibrate
11223718|NCT02354976|OG000|Outcome|Epanova|Epanova 4 g/day + placebo to Fenofibrate
10997091|NCT01036438|BG000|Baseline|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
11223719|NCT02354976|OG001|Outcome|Placebo|Placebo to Epanova + placebo to Fenofibrate
11223720|NCT02354976|OG001|Outcome|Fenofibrate|Fenofibrate 200 mg/ day + placebo to Epanova
11223721|NCT02354976|EG000|Reported Event|Epanova|Epanova 4 g/day + placebo to Fenofibrate
11223722|NCT02354976|EG001|Reported Event|Fenofibrate|Fenofibrate 200 mg/ day + placebo to Epanova
11223723|NCT02354976|EG002|Reported Event|Placebo|Placebo to Epanova + placebo to Fenofibrate
11223724|NCT02355028|BG000|Baseline|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
11223725|NCT02355028|BG001|Baseline|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
11223726|NCT02355028|BG002|Baseline|Total|Total of all reporting groups
10997092|NCT01036438|BG001|Baseline|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
10997093|NCT01036438|BG002|Baseline|Total|Total of all reporting groups
10997094|NCT01036438|FG000|Participant Flow|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
11223727|NCT02355028|FG000|Participant Flow|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
11223728|NCT02355028|FG001|Participant Flow|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
11223729|NCT02355028|OG000|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
11223730|NCT02355028|OG001|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
10997095|NCT01036438|FG001|Participant Flow|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
10997096|NCT01036438|OG000|Outcome|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
10997097|NCT01036438|OG001|Outcome|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
11223731|NCT02355028|OG000|Outcome|LHA510|LHA510 dose twice daily (BID) by Day 28, LHA510 dose once daily (QD) by Day 84, LHA510 dose 3-times daily (TID) by Day 84
11223732|NCT02355028|OG001|Outcome|CRA398|Metabolite of LHA510
11223733|NCT02355028|EG000|Reported Event|Pre-treatment|All subjects with AE/s reported prior to the initiation of IP administration
11223734|NCT02355028|EG001|Reported Event|LHA510|All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration
11223735|NCT02355028|EG002|Reported Event|Vehicle|All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration
11223736|NCT02355028|EG003|Reported Event|Post-treatment LHA510|All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
11223737|NCT02355028|EG004|Reported Event|Post-treatment Vehicle|All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
10997098|NCT01036438|EG000|Reported Event|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
10997099|NCT01036438|EG001|Reported Event|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
10997100|NCT01036490|BG000|Baseline|Exercise|12-week (3 days per week) program of aerobic and resistance training followed by 40 weeks of a home exercise program plus nutritional counseling
10997101|NCT01036490|BG001|Baseline|Control|Nutritional counseling alone
10997102|NCT01036490|BG002|Baseline|Total|Total of all reporting groups
10997103|NCT01036490|FG000|Participant Flow|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
10997104|NCT01036490|FG001|Participant Flow|Control|Dietary management alone
10997105|NCT01036490|OG000|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
10997106|NCT01036490|OG001|Outcome|Control|Dietary management alone
10997107|NCT01036490|EG000|Reported Event|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
10997108|NCT01036490|EG001|Reported Event|Control|Dietary management alone
10997109|NCT01036529|BG000|Baseline|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
10997110|NCT01036529|BG001|Baseline|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
10997111|NCT01036529|BG002|Baseline|Total|Total of all reporting groups
10997112|NCT01036529|FG000|Participant Flow|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulator Intervention
10997113|NCT01036529|FG001|Participant Flow|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
10997114|NCT01036529|OG000|Outcome|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
10997115|NCT01036529|OG001|Outcome|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
10997116|NCT01036529|EG000|Reported Event|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
10997117|NCT01036529|EG001|Reported Event|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
10997118|NCT01036594|BG000|Baseline|All Patients Who Received Treatment|"po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days~Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid~Hydrocortisone 20mg po qam and 10mg po qpm: If patient has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If participant has < 30% PSA decline at 12 week evaluation, participant goes off study.~Based on the results of evaluation at 12 weeks , participants were offered to either stay on this regimen or receive~-Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented."
10997119|NCT01036594|FG000|Participant Flow|Ketoconazole + Hydrocortisone|"po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days~Ketoconazole: 200mg during run-in phase, then 400mg po tid~Hydrocortisone 20mg po qam and 10mg po qpm: If participant has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by Prostate Specific Antigen Working Group (PSAWG) criteria) is documented. After that, drug will be discontinued. If participant has < 30% PSA decline at 12 week evaluation, participant goes off study."
10997120|NCT01036594|FG001|Participant Flow|Ketoconazole + Dexamethasone|Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
10997121|NCT01036594|OG000|Outcome|Ketoconazole + Hydrocortisone|"po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days~Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid~Hydrocortisone 20mg po qam and 10mg po qpm: If patient has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If patient has < 30% PSA decline at 12 week evaluation, patient goes off study."
10997122|NCT01036594|OG001|Outcome|Ketoconazole + Dexamethasone|Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
10997123|NCT01036594|EG000|Reported Event|Ketoconazole + Hydrocortisone|"po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days~Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid~Hydrocortisone 20mg po qam and 10mg po qpm: If patient has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If patient has < 30% PSA decline at 12 week evaluation, patient goes off study."
10997124|NCT01036594|EG001|Reported Event|Ketoconazole + Dexamethasone|Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
10997125|NCT01036724|BG000|Baseline|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
10997126|NCT01036724|BG001|Baseline|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
10997127|NCT01036724|BG002|Baseline|Total|Total of all reporting groups
10997128|NCT01036724|FG000|Participant Flow|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
10997129|NCT01036724|FG001|Participant Flow|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
10997130|NCT01036724|OG000|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
10997131|NCT01036724|OG001|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
10997132|NCT01036724|EG000|Reported Event|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
10997133|NCT01036724|EG001|Reported Event|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
10997134|NCT01036763|BG000|Baseline|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
10997135|NCT01036763|FG000|Participant Flow|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
10997136|NCT01036763|OG000|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
10997137|NCT01036763|EG000|Reported Event|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
11007580|NCT01091519|OG000|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
11007581|NCT01091519|OG001|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
11007582|NCT01091519|EG000|Reported Event|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
11007583|NCT01091519|EG001|Reported Event|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
11007584|NCT01091662|BG000|Baseline|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
11007585|NCT01091662|BG001|Baseline|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepineacetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
11007586|NCT01091662|BG002|Baseline|Total|Total of all reporting groups
11007587|NCT01091662|FG000|Participant Flow|ESL 1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
11007588|NCT01091662|FG001|Participant Flow|ESL1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
11007589|NCT01091662|OG000|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
11007590|NCT01091662|OG001|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
11007591|NCT01091662|OG000|Outcome|ESL 1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
11007592|NCT01091662|OG001|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
11007593|NCT01091662|OG000|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
11007594|NCT01091662|OG000|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
11007595|NCT01091662|OG001|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
11007596|NCT01091662|EG000|Reported Event|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
11007597|NCT01091662|EG001|Reported Event|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
11007598|NCT01091675|BG000|Baseline|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
11007599|NCT01091675|FG000|Participant Flow|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
11007600|NCT01091675|OG000|Outcome|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
11007601|NCT01091675|EG000|Reported Event|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
10997138|NCT01036802|BG000|Baseline|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
10997139|NCT01036802|BG001|Baseline|Placebo|Patients were randomized to placebo
10997140|NCT01036802|BG002|Baseline|Total|Total of all reporting groups
10997141|NCT01036802|FG000|Participant Flow|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
10997142|NCT01036802|FG001|Participant Flow|Placebo|Patients were randomized to placebo
10997143|NCT01036802|OG000|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
10997144|NCT01036802|OG001|Outcome|Placebo|Patients were randomized to placebo
10997145|NCT01036802|OG001|Outcome|Placebo|Patients were on placebo
10997146|NCT01036802|EG000|Reported Event|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
10997147|NCT01036802|EG001|Reported Event|Placebo|Patients were randomized to placebo
10997148|NCT01037088|BG000|Baseline|All Participants|All participants who were randomized
10997149|NCT01037088|FG000|Participant Flow|All Participants|All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.
10997150|NCT01037088|OG000|Outcome|Mild Dose Cannabis|3.53% THC by weight
10997151|NCT01037088|OG001|Outcome|Low Dose Cannabis|1.29% THC by weight
10997152|NCT01037088|OG002|Outcome|Placebo Cannabis|trace THC by weight
10997153|NCT01037088|OG002|Outcome|Placebo Cannabis|0.00% THC by weight
10997154|NCT01037088|EG000|Reported Event|Mild Dose Cannabis|3.53% 9-delta tetrahydrocannabinol by weight
10997155|NCT01037088|EG001|Reported Event|Low Dose Cannabis|1.29% 9-delta tetrahydrocannabinol by weight
10997156|NCT01037088|EG002|Reported Event|Placebo Cannabis|0% 9-delta tetrahydrocannabinol by weight
10997157|NCT01037114|BG000|Baseline|Twinrix Group|"Subjects who received 3 doses of Twinrix (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point."
10997158|NCT01037114|FG000|Participant Flow|Twinrix Group|"Subjects who received 3 doses of Twinrix (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point."
10997159|NCT01037114|OG000|Outcome|Twinrix Group|"Subjects who received 3 doses of Twinrix (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point."
10997160|NCT01037114|EG000|Reported Event|Twinrix Group|"Subjects who received 3 doses of Twinrix (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point."
10997161|NCT01037127|BG000|Baseline|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
10997162|NCT01037127|BG001|Baseline|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
10997163|NCT01037127|BG002|Baseline|Total|Total of all reporting groups
10997164|NCT01037127|FG000|Participant Flow|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib (GSK1120212) 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
11007602|NCT01091948|BG000|Baseline|Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.~Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope."
10877702|NCT00448708|BG000|Baseline|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
10877703|NCT00448708|BG001|Baseline|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
10877704|NCT00448708|BG002|Baseline|Total|Total of all reporting groups
10877705|NCT00448708|FG000|Participant Flow|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
10877706|NCT00448708|FG001|Participant Flow|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
10877707|NCT00448708|OG000|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
10877708|NCT00448708|OG001|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
10877709|NCT00448708|EG000|Reported Event|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
10877710|NCT00448708|EG001|Reported Event|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
10877711|NCT00448747|BG000|Baseline|AGHD Patients (= Cases)|All AGHD patients enrolled in the study.
10877712|NCT00448747|BG001|Baseline|Matched Controls (= Controls)|All matched control subjects enrolled in the study.
10877713|NCT00448747|BG002|Baseline|Total|Total of all reporting groups
10877714|NCT00448747|FG000|Participant Flow|AGHD Patients (= Cases)|All Adult Growth Hormone Deficiency (AGHD) patients enrolled in the study.
10877715|NCT00448747|FG001|Participant Flow|Matched Controls (= Controls)|All matched control subjects enrolled in the study.
10877716|NCT00448747|OG000|Outcome|Cases/AEZS-130 Administered|All AGHD patients who were enrolled in the study and following macimorelin administration.
10877717|NCT00448747|OG001|Outcome|Control/AEZS-130 Administered|All matched control subjects who enrolled in the study and following macimorelin administration.
10877718|NCT00448747|OG000|Outcome|Case/AEZS-130 Administered|All AGHD patients who received macimorelin.
10877719|NCT00448747|OG001|Outcome|Control/AEZS-130 Administered|All matched control subjects who received macimorelin.
10877720|NCT00448747|OG000|Outcome|Peak GH|"CART analysis of Peak GH following macimorelin administration~Case Definition: GH ≤ 2.85 Control Definition: GH > 2.85"
10877721|NCT00448747|OG001|Outcome|Peak GH & BMI|"CART analysis of Peak GH following macimorelin & BMI~Case Definition: GH ≤ 2.85 or (2.85 <GH ≤7.15 & BMI ≤37.28) Control Definition: GH >7.15 or (2.85<GH≤7.15 and BMI>37.28)"
10877722|NCT00448747|OG002|Outcome|Peak GH & Age|"CART analysis of Peak GH following macimorelin & Age~Case Definition: GH ≤ 2.85 or (2.85 <GH ≤7.15 & age ≤47.5) Control Definition: GH > 7.15 or (2.85 <GH ≤7.15 & age >47.5)"
10877723|NCT00448747|OG003|Outcome|Peak GH & BMI & Age|"CART analysis of Peak GH following macimorelin & BMI & Age~Case Definition:~GH≤0.85 or (0.85<GH≤2.85 and BMI>27.94) or (2.85<GH≤7.15 and age ≤47.5)~Control Definition:~GH > 7.15 or (0.85 <GH ≤2.85 & BMI ≤27.94) or (2.85<GH≤7.15 and age >47.5)"
10877724|NCT00448747|OG000|Outcome|AGHD Patients (=Cases)|All AGHD patients who were enrolled in this study.
10877725|NCT00448747|OG001|Outcome|Match Control (= Control)|All matched control subjects who were enrolled in the study.
10877726|NCT00448747|EG000|Reported Event|AEZS-130: Cases|All AGHD patients (cases) who received AEZS-130 (macimorelin).
10877727|NCT00448747|EG001|Reported Event|AEZS-130: Controls|All matched control subjects who received AEZS-130 (macimorelin).
10877728|NCT00448747|EG002|Reported Event|L-ARG+GHRH: Cases|All AGHD patients (cases) who received L-ARG+GHRH.
10877729|NCT00448747|EG003|Reported Event|L-ARG+GHRH: Controls|All matched control subjects who received L-ARG+GHRH.
10877730|NCT00448760|BG000|Baseline|Single Arm|5-Fluorodeoxyuridine, Leucovorin, Oxaliplatin and Docetaxel
10877731|NCT00448760|FG000|Participant Flow|Neoadjuvant + Adjuvant Chemotherapy|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
10877732|NCT00448760|OG000|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
10877733|NCT00448760|EG000|Reported Event|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
10877734|NCT00448812|BG000|Baseline|Alair Treatment|"Alair treated subjects from PREDECESSOR STUDY (NCT00214526).~Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY."
10877735|NCT00448812|BG001|Baseline|Control|Control group subjects from PREDECESSOR STUDY (NCT00214526).
10877736|NCT00448812|BG002|Baseline|Total|Total of all reporting groups
10877737|NCT00448812|FG000|Participant Flow|Alair|Alair-treated subjects from AIR PREDECESSOR STUDY (NCT00214526).
10877738|NCT00448812|FG001|Participant Flow|Control|Control subjects from AIR PREDECESSOR STUDY (NCT00214526).
10877739|NCT00448812|OG000|Outcome|Alair Year 1|"Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1.~Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY"
10877740|NCT00448812|OG001|Outcome|Alair Year 2|"Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2.~Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY"
10997165|NCT01037127|FG001|Participant Flow|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
10997166|NCT01037127|OG000|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
10997167|NCT01037127|OG001|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
10997168|NCT01037127|OG000|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis, who were previously treated with standard therapy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
10997169|NCT01037127|OG001|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis, who were previoulsy treated with standard thearpy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
10997170|NCT01037127|OG002|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with a positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
10997171|NCT01037127|OG003|Outcome|Participants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with a positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
10997172|NCT01037127|OG004|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with a positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
11223738|NCT02355067|BG000|Baseline|Social Media Format|"Social Media Intervention for women with postpartum depression (PPD) symptoms~Social Media Intervention: These women will participate in the intervention through the online Facebook group."
11223739|NCT02355067|BG001|Baseline|In-Person Format|"Traditional In-Person Intervention for Women with postpartum depression (PPD)~Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person."
11223740|NCT02355067|BG002|Baseline|Total|Total of all reporting groups
11223741|NCT02355067|FG000|Participant Flow|Social Media Format|"Social Media Intervention for women with postpartum depression (PPD) symptoms~Social Media Intervention: These women will participate in the intervention through the online Facebook group."
11223742|NCT02355067|FG001|Participant Flow|In-Person Format|"Traditional In-Person Intervention for Women with postpartum depression (PPD)~Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person."
11223743|NCT02355067|OG000|Outcome|Social Media Format|"Social Media Intervention for women with postpartum depression (PPD) symptoms~Social Media Intervention: These women will participate in the intervention through the online Facebook group."
11223744|NCT02355067|OG001|Outcome|In-Person Format|"Traditional In-Person Intervention for Women with postpartum depression (PPD)~Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person."
11223745|NCT02355067|EG000|Reported Event|Social Media Format|"Social Media Intervention for women with postpartum depression (PPD) symptoms~Social Media Intervention: These women will participate in the intervention through the online Facebook group."
11223746|NCT02355067|EG001|Reported Event|In-Person Format|"Traditional In-Person Intervention for Women with postpartum depression (PPD)~Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person."
11223747|NCT02355158|BG000|Baseline|Active|"Clonidine hydrochloride topical gel, 0.1%~clonidine hydrochloride topical gel, 0.1%"
11223748|NCT02355158|FG000|Participant Flow|Active|"Clonidine hydrochloride topical gel, 0.1%~clonidine hydrochloride topical gel, 0.1%"
11223749|NCT02355158|OG000|Outcome|Active|"Clonidine hydrochloride topical gel, 0.1%~clonidine hydrochloride topical gel, 0.1%"
11223750|NCT02355158|EG000|Reported Event|Active|"Clonidine hydrochloride topical gel, 0.1%~clonidine hydrochloride topical gel, 0.1%"
11223751|NCT02355210|BG000|Baseline|Placebo|5 g lactose given as a placebo
11223752|NCT02355210|BG001|Baseline|Probiotic 1|Bifidobacteria adolescentis BD1, 10^9
11223753|NCT02355210|BG002|Baseline|Probiotic 2|Bifidobacteria animalis subsp. lactis BB-12, 10^9
11223754|NCT02355210|BG003|Baseline|Synbiotic 1|galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9)
11223755|NCT02355210|BG004|Baseline|Synbiotic 2|galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9)
11223756|NCT02355210|BG005|Baseline|Prebiotic|galactooligosaccaride, 5 g
10845719|NCT00269113|OG000|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
10997173|NCT01037127|OG000|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
11223757|NCT02355210|BG006|Baseline|Total|Total of all reporting groups
11223758|NCT02355210|FG000|Participant Flow|Placebo|5 g lactose given as a placebo
11223759|NCT02355210|FG001|Participant Flow|Probiotic 1|Bifidobacteria adolescentis BD1, 10^9
11223760|NCT02355210|FG002|Participant Flow|Probiotic 2|Bifidobacteria animalis subsp. lactis BB-12, 10^9
11223761|NCT02355210|FG003|Participant Flow|Synbiotic 1|galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9)
11223762|NCT02355210|FG004|Participant Flow|Synbiotic 2|galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9)
11223763|NCT02355210|FG005|Participant Flow|Prebiotic|galactooligosaccharide, 5 g
11223764|NCT02355210|OG000|Outcome|Placebo|5 g lactose given as a placebo
11223765|NCT02355210|OG001|Outcome|Probiotic 1|Bifidobacteria adolescentis BD1, 10^9
11223766|NCT02355210|OG002|Outcome|Probiotic 2|Bifidobacteria animalis subsp. lactis BB-12, 10^9
11223767|NCT02355210|OG003|Outcome|Synbiotic 1|galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9)
10845720|NCT00269113|OG001|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
10845721|NCT00269113|EG000|Reported Event|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
10845722|NCT00269113|EG001|Reported Event|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
10845723|NCT00269152|BG000|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
10845724|NCT00269152|BG001|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
10845725|NCT00269152|BG002|Baseline|Total|Total of all reporting groups
10845726|NCT00269152|FG000|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
10845727|NCT00269152|FG001|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
10845728|NCT00269152|OG000|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
10845729|NCT00269152|OG001|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
10845730|NCT00269152|EG000|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
10997174|NCT01037127|OG001|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
10997175|NCT01037127|OG002|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
10997176|NCT01037127|OG003|Outcome|Paticipants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
10997177|NCT01037127|OG004|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
10997178|NCT01037127|EG000|Reported Event|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
10997179|NCT01037127|EG001|Reported Event|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
10997180|NCT01037192|BG000|Baseline|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
10997181|NCT01037192|BG001|Baseline|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
10997182|NCT01037192|BG002|Baseline|Total|Total of all reporting groups
10997183|NCT01037192|FG000|Participant Flow|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
10997184|NCT01037192|FG001|Participant Flow|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
10997185|NCT01037192|OG000|Outcome|Vancomycin Once Daily|Vancomycin 30 mg/kg IV daily
10997186|NCT01037192|OG001|Outcome|Vancomycin Twice Daily|Vancomycin 15 mg/kg IV twice daily
10997187|NCT01037192|OG000|Outcome|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
10997188|NCT01037192|OG001|Outcome|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
10997189|NCT01037192|EG000|Reported Event|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
11223768|NCT02355210|OG004|Outcome|Synbiotic 2|galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9)
10997190|NCT01037192|EG001|Reported Event|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
10997191|NCT01037218|BG000|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
10997192|NCT01037218|BG001|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
10997193|NCT01037218|BG002|Baseline|Udenafil 150mg|Udenafil 150mg tablets
10997194|NCT01037218|BG003|Baseline|Placebo|Placebo tablets
10997195|NCT01037218|BG004|Baseline|Total|Total of all reporting groups
10997196|NCT01037218|FG000|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
10997197|NCT01037218|FG001|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
10997198|NCT01037218|FG002|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
10997199|NCT01037218|FG003|Participant Flow|Placebo|Placebo tablets
10997200|NCT01037218|OG000|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
10997201|NCT01037218|OG001|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
10997202|NCT01037218|OG002|Outcome|Udenafil 150mg|Udenafil 150mg tablets
10997203|NCT01037218|OG003|Outcome|Placebo|Placebo tablets
10997204|NCT01037218|EG000|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
10997205|NCT01037218|EG001|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
10997206|NCT01037218|EG002|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
10997207|NCT01037218|EG003|Reported Event|Placebo|Placebo tablets
10997208|NCT01037244|BG000|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
10997209|NCT01037244|BG001|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
10997210|NCT01037244|BG002|Baseline|Udenafil 150mg|Udenafil 150mg tablets
10997211|NCT01037244|BG003|Baseline|Placebo|Placebo tablets
10997212|NCT01037244|BG004|Baseline|Total|Total of all reporting groups
10997213|NCT01037244|FG000|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
10997214|NCT01037244|FG001|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
10997215|NCT01037244|FG002|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
10997216|NCT01037244|FG003|Participant Flow|Placebo|Placebo tablets
10997217|NCT01037244|OG000|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
10997218|NCT01037244|OG001|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
10997219|NCT01037244|OG002|Outcome|Udenafil 150mg|Udenafil 150mg tablets
10997220|NCT01037244|OG003|Outcome|Placebo|Placebo tablets
10997221|NCT01037244|EG000|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
10997222|NCT01037244|EG001|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
10997223|NCT01037244|EG002|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
10997224|NCT01037244|EG003|Reported Event|Placebo|Placebo tablets
10997225|NCT01037309|BG000|Baseline|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997226|NCT01037309|BG001|Baseline|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997227|NCT01037309|BG002|Baseline|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997228|NCT01037309|BG003|Baseline|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997229|NCT01037309|BG004|Baseline|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997230|NCT01037309|BG005|Baseline|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997231|NCT01037309|BG006|Baseline|Total|Total of all reporting groups
10997232|NCT01037309|FG000|Participant Flow|Subcutaneous PRO044 0.5 mg/kg|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997233|NCT01037309|FG001|Participant Flow|Subcutaneous PRO044 1.5 mg/kg|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997234|NCT01037309|FG002|Participant Flow|Subcutaneous PRO044 5 mg/kg|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997235|NCT01037309|FG003|Participant Flow|Subcutaneous PRO044 8 mg/kg|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
11223769|NCT02355210|OG005|Outcome|Prebiotic|galactooligosaccharide, 5 g
10997236|NCT01037309|FG004|Participant Flow|Subcutaneous PRO044 10 mg/kg|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997237|NCT01037309|FG005|Participant Flow|Subcutaneous PRO044 12 mg/kg|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997238|NCT01037309|FG006|Participant Flow|Intravenous PRO044 1.5 mg/kg|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997239|NCT01037309|FG007|Participant Flow|Intravenous PRO044 5 mg/kg|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997240|NCT01037309|FG008|Participant Flow|Intravenous PRO044 8 mg/kg|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997241|NCT01037309|OG000|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997242|NCT01037309|OG001|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997243|NCT01037309|OG002|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997244|NCT01037309|OG003|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997245|NCT01037309|OG004|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997246|NCT01037309|OG005|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997247|NCT01037309|OG006|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997248|NCT01037309|OG007|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997249|NCT01037309|OG008|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997250|NCT01037309|OG006|Outcome|PRO044, Cohort 7|"IV injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: IV, once a week, for five weeks"
11223770|NCT02355210|EG000|Reported Event|Placebo|5 g lactose given as a placebo
10997251|NCT01037309|OG007|Outcome|PRO044, Cohort 8|"IV injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: IV, once a week, for five weeks"
10997252|NCT01037309|OG008|Outcome|PRO044, Cohort 9|"IV injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: IV, once a week, for five weeks"
10997253|NCT01037309|EG000|Reported Event|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997254|NCT01037309|EG001|Reported Event|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997255|NCT01037309|EG002|Reported Event|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
10997256|NCT01037309|EG003|Reported Event|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
11223771|NCT02355210|EG001|Reported Event|Probiotic 1|Bifidobacteria adolescentis BD1, 10^9
11223772|NCT02355210|EG002|Reported Event|Probiotic 2|Bifidobacteria animalis subsp. lactis BB-12, 10^9
11223773|NCT02355210|EG003|Reported Event|Synbiotic 1|galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9)
11223774|NCT02355210|EG004|Reported Event|Synbiotic 2|galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9)
10997257|NCT01037309|EG004|Reported Event|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
11223775|NCT02355210|EG005|Reported Event|Prebiotic|galactooligosaccaride, 5 g
11223776|NCT02355275|BG000|Baseline|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
11223777|NCT02355275|FG000|Participant Flow|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
11223778|NCT02355275|OG000|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
11223779|NCT02355275|EG000|Reported Event|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
11223780|NCT02355665|BG000|Baseline|Placebo|Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
11223781|NCT02355665|BG001|Baseline|Nicotine|Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
11223782|NCT02355665|BG002|Baseline|Total|Total of all reporting groups
11223783|NCT02355665|FG000|Participant Flow|Placebo|Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
11223784|NCT02355665|FG001|Participant Flow|Nicotine|Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
11223785|NCT02355665|OG000|Outcome|Placebo|Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
11223786|NCT02355665|OG001|Outcome|Nicotine|Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
10997258|NCT01037309|EG005|Reported Event|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
11223787|NCT02355665|EG000|Reported Event|Placebo|Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
11223788|NCT02355665|EG001|Reported Event|Nicotine|Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
11223789|NCT02355691|BG000|Baseline|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
11223790|NCT02355691|BG001|Baseline|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
11223791|NCT02355691|BG002|Baseline|Total|Total of all reporting groups
11223792|NCT02355691|FG000|Participant Flow|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
11223793|NCT02355691|FG001|Participant Flow|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
11223794|NCT02355691|OG000|Outcome|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
11223795|NCT02355691|OG001|Outcome|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
11223796|NCT02355691|EG000|Reported Event|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
11223797|NCT02355691|EG001|Reported Event|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
11223798|NCT02355743|BG000|Baseline|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as lock therapy in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
11336460|NCT03566823|BG002|Baseline|Ontamalimab 75 mg|Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11336461|NCT03566823|BG003|Baseline|Total|Total of all reporting groups
11336462|NCT03566823|FG000|Participant Flow|Placebo|Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10997259|NCT01037309|EG006|Reported Event|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997260|NCT01037309|EG007|Reported Event|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997261|NCT01037309|EG008|Reported Event|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
10997262|NCT01037413|BG000|Baseline|All Enrolled Participants|All participants who were enrolled in the study.
10997263|NCT01037413|FG000|Participant Flow|EXC 001 During Part A|In Part A, participants received 2 intradermal injections of EXC 001 at a dose of 5 milligram (mg) on Day 1 and 21, on lower back. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to scar revision surgery.
10997264|NCT01037413|FG001|Participant Flow|EXC 001 + Placebo During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear centimeter (cm) to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997265|NCT01037413|OG000|Outcome|EXC 001 During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997266|NCT01037413|OG001|Outcome|Placebo During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.
11223799|NCT02355743|FG000|Participant Flow|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as lock therapy in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
11223800|NCT02355743|OG000|Outcome|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as lock therapy in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
10997267|NCT01037413|OG000|Outcome|EXC 001 During Part A|In Part A, participants received 2 intradermal injections of EXC 001 at a dose of 5 mg on Day 1 and 21, on lower back. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to scar revision surgery.
10997268|NCT01037413|OG001|Outcome|EXC 001 + Placebo During Part B, Active Dosing Phase|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed. Active dosing was the time period from Week 2 to Week 13.
10997269|NCT01037413|OG002|Outcome|Part B, Post Dosing Phase|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
10997270|NCT01037413|OG000|Outcome|Overall Study|In Part A, participants received 2 intradermal injections of EXC 001 at a dose of 5 mg on Day 1 and 21, on lower back. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery. Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast, at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997271|NCT01037413|OG000|Outcome|Overall Study|In Part A, participants received 2 intradermal injections of EXC 001 at a dose of 5 milligram (mg) on Day 1 and 21, on lower back. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery. The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until the day of surgery in Part B. Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast, at Week 2, 5, 8, and 11 after the surgical incision was closed.
11007603|NCT01091948|BG001|Baseline|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.~GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
10997272|NCT01037413|OG001|Outcome|EXC 001 + Placebo During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997273|NCT01037413|EG000|Reported Event|EXC 001 During Part A|In Part A, participants received 2 intradermal injections of EXC 001 at a dose of 5 mg on Day 1 and 21, on lower back. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to scar revision surgery.
10997274|NCT01037413|EG001|Reported Event|EXC 001 + Placebo During Part B, Active Dosing Phase|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997275|NCT01037413|EG002|Reported Event|Part B, Post Dosing Phase|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
10997276|NCT01037452|BG000|Baseline|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
10997277|NCT01037452|BG001|Baseline|PPI Alone|Lansoprazole 15 mg, single dose
10997278|NCT01037452|BG002|Baseline|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
10997279|NCT01037452|BG003|Baseline|Placebo|Placebo, single dose
10997280|NCT01037452|BG004|Baseline|Total|Total of all reporting groups
10997281|NCT01037452|FG000|Participant Flow|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
10997282|NCT01037452|FG001|Participant Flow|PPI Alone|Lansoprazole 15 mg, single dose
10997283|NCT01037452|FG002|Participant Flow|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
10997284|NCT01037452|FG003|Participant Flow|Placebo|Placebo, single dose
10997285|NCT01037452|OG000|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
10997286|NCT01037452|OG001|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
10997287|NCT01037452|OG002|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
10997288|NCT01037452|OG003|Outcome|Placebo|Placebo, single dose
10997289|NCT01037452|EG000|Reported Event|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
10997290|NCT01037452|EG001|Reported Event|PPI Alone|Lansoprazole 15 mg, single dose
10997291|NCT01037452|EG002|Reported Event|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
10997292|NCT01037452|EG003|Reported Event|Placebo|Placebo, single dose
10997293|NCT01037790|BG000|Baseline|Arm 1|"Metastatic breast cancer~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997294|NCT01037790|BG001|Baseline|Arm 2|"Metastatic colorectal cancer that harbors the Kras or BRAF mutation~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997295|NCT01037790|BG002|Baseline|Arm 3|"Advanced or metastatic esophageal and/or gastric cancer~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997296|NCT01037790|BG003|Baseline|Arm 4|"Cisplatin-refractory, unresectable germ cell tumors~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997297|NCT01037790|BG004|Baseline|Arm 5|"Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997298|NCT01037790|BG005|Baseline|Total|Total of all reporting groups
10997299|NCT01037790|FG000|Participant Flow|Arm 1|"Metastatic breast cancer~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997300|NCT01037790|FG001|Participant Flow|Arm 2|"Metastatic colorectal cancer that harbors the Kras or BRAF mutation~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997301|NCT01037790|FG002|Participant Flow|Arm 3|"Advanced or metastatic esophageal and/or gastric cancer~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997302|NCT01037790|FG003|Participant Flow|Arm 4|"Cisplatin-refractory, unresectable germ cell tumors~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997303|NCT01037790|FG004|Participant Flow|Arm 5|"Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997304|NCT01037790|OG000|Outcome|Arm 1|"Metastatic breast cancer~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997305|NCT01037790|OG001|Outcome|Arm 2|"Metastatic colorectal cancer that harbors the Kras or BRAF mutation~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997306|NCT01037790|OG002|Outcome|Arm 3|"Advanced or metastatic esophageal and/or gastric cancer~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997307|NCT01037790|OG003|Outcome|Arm 4|"Cisplatin-refractory, unresectable germ cell tumors~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997308|NCT01037790|OG004|Outcome|Arm 5|"Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997309|NCT01037790|EG000|Reported Event|Arm 1|"Metastatic breast cancer~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997310|NCT01037790|EG001|Reported Event|Arm 2|"Metastatic colorectal cancer that harbors the Kras or BRAF mutation~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997311|NCT01037790|EG002|Reported Event|Arm 3|"Advanced or metastatic esophageal and/or gastric cancer~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997312|NCT01037790|EG003|Reported Event|Arm 4|"Cisplatin-refractory, unresectable germ cell tumors~PD-0332991: Given orally, 125 mg QD on a 21-day"
11007604|NCT01091948|BG002|Baseline|Total|Total of all reporting groups
10997313|NCT01037790|EG004|Reported Event|Arm 5|"Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.~PD-0332991: Given orally, 125 mg QD on a 21-day"
10997314|NCT01037881|BG000|Baseline|LEO 29102 Vehicle|Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
10997315|NCT01037881|BG001|Baseline|LEO 29102 0.03 mg/g|Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997316|NCT01037881|BG002|Baseline|LEO 29102 0.1 mg/g|Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997317|NCT01037881|BG003|Baseline|LEO 29102 0.3 mg/g|Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997318|NCT01037881|BG004|Baseline|LEO 29102 1.0 mg/g|Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997319|NCT01037881|BG005|Baseline|LEO 29102 2.5 mg/g|Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997320|NCT01037881|BG006|Baseline|Elidel® 10 mg/g|Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
10997321|NCT01037881|BG007|Baseline|Total|Total of all reporting groups
10997322|NCT01037881|FG000|Participant Flow|LEO 29102 Vehicle|LEO 29102 cream vehicle applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total body surface area (BSA) for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an investigator's global assessment [IGA] of 0 or 1, i.e. clear or almost clear of symptoms) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Visit 6 (Day 56). The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
10997323|NCT01037881|FG001|Participant Flow|LEO 29102 0.03 mg/g|LEO 29102 0.03 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1, i.e. clear or almost clear of symptoms) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
10997324|NCT01037881|FG002|Participant Flow|LEO 29102 0.1 mg/g|LEO 29102 0.1 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
10997325|NCT01037881|FG003|Participant Flow|LEO 29102 0.3 mg/g|LEO 29102 0.3 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
10997326|NCT01037881|FG004|Participant Flow|LEO 29102 1.0 mg/g|"LEO 29102 1.0 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participant had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.~Participants were not randomized to this treatment until the results from the hormone screen blood samples from at least 10 participants in each of the five initial treatment arms (LEO 29102 0.03 mg/g cream, 0.1 mg/g cream,0.3 mg/g cream, cream vehicle, and Elidel®) were available and no safety concerns had been raised."
10997327|NCT01037881|FG005|Participant Flow|LEO 29102 2.5 mg/g|"LEO 29102 2.5 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.~Participants were not randomized to this treatment until the results from the hormone screen blood samples from at least 10 participants in each of the five initial treatment arms (LEO 29102 0.03 mg/g cream, 0.1 mg/g cream,0.3 mg/g cream, cream vehicle, and Elidel®) were available and no safety concerns had been raised."
11007605|NCT01091948|FG000|Participant Flow|Active Comparator: Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.~Active Comparator: GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope"
11007606|NCT01091948|FG001|Participant Flow|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.~GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
11336463|NCT03566823|FG001|Participant Flow|Ontamalimab 25 mg|Participants received ontamalimab 25 milligram (mg), injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11336464|NCT03566823|FG002|Participant Flow|Ontamalimab 75 mg|Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10997328|NCT01037881|FG006|Participant Flow|Elidel® 10 mg/g|"Elidel® applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks.~Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed."
10997329|NCT01037881|OG000|Outcome|LEO 29102 Vehicle|Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
10997330|NCT01037881|OG001|Outcome|LEO 29102 0.03 mg/g|Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997331|NCT01037881|OG002|Outcome|LEO 29102 0.1 mg/g|Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997332|NCT01037881|OG003|Outcome|LEO 29102 0.3 mg/g|Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997333|NCT01037881|OG004|Outcome|LEO 29102 1.0 mg/g|Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
11223801|NCT02355743|EG000|Reported Event|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as lock therapy in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
11223802|NCT02355821|BG000|Baseline|Moxonidine|"0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID~Moxonidine: 0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID Other Names:perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D"
11223803|NCT02355821|BG001|Baseline|Bisoprolol|"5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID~Bisoprolol: 5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID Other Names: perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D"
11223804|NCT02355821|BG002|Baseline|Total|Total of all reporting groups
11223805|NCT02355821|FG000|Participant Flow|Moxonidine|"0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID~Moxonidine: 0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID Other Names:perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D"
11223806|NCT02355821|FG001|Participant Flow|Bisoprolol|"5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID~Bisoprolol: 5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID Other Names: perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D"
10997334|NCT01037881|OG005|Outcome|LEO 29102 2.5 mg/g|Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 week
10997335|NCT01037881|OG006|Outcome|Elidel® 10 mg/g|Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
10997336|NCT01037881|OG005|Outcome|LEO 29102 2.5 mg/g|Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997337|NCT01037881|OG006|Outcome|Elidel®10 mg/g|Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
10997338|NCT01037881|EG000|Reported Event|LEO 29102 Cream Vehicle - Treatment Phase|Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
10997339|NCT01037881|EG001|Reported Event|LEO 29102 0.03 mg/g Cream - Treatment Phase|Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997340|NCT01037881|EG002|Reported Event|LEO 29102 0.1 mg/g Cream - Treatment Phase|Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997341|NCT01037881|EG003|Reported Event|LEO 29102 0.3 mg/g Cream - Treatment Phase|Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10845166|NCT00265395|OG000|Outcome|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
10997342|NCT01037881|EG004|Reported Event|LEO 29102 1.0 mg/g Cream - Treatment Phase|Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997343|NCT01037881|EG005|Reported Event|LEO 29102 2.5 mg/g Cream - Treatment Phase|Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997344|NCT01037881|EG006|Reported Event|Elidel® Cream (Pimecrolimus) 10 mg/g - Treatment Phase|Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
10997345|NCT01037881|EG007|Reported Event|LEO 29102 Cream Vehicle - Follow-up Phase|Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
10997346|NCT01037881|EG008|Reported Event|LEO 29102 0.03 mg/g Cream - Follow-up Phase|Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997347|NCT01037881|EG009|Reported Event|LEO 29102 0.1 mg/g Cream - Follow-up Phase|Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997348|NCT01037881|EG010|Reported Event|LEO 29102 0.3 mg/g Cream - Follow-up Phase|Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997349|NCT01037881|EG011|Reported Event|LEO 29102 1.0 mg/g Cream - Follow-up Phase|Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997350|NCT01037881|EG012|Reported Event|LEO 29102 2.5 mg/g Cream - Follow-up Phase|Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
10997351|NCT01037881|EG013|Reported Event|Elidel® 10 mg/g - Follow-up Phase|Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
10997352|NCT01037985|BG000|Baseline|All Enrolled Participants|All participants who were enrolled in the study.
10997353|NCT01037985|FG000|Participant Flow|EXC 001 (PF-0647387) During Part A|In Part A participants received 2 intradermal injections on lower back of EXC 001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery. The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery in Part B.
10997354|NCT01037985|FG001|Participant Flow|EXC 001 (PF-0647387) + Placebo During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear centimeter (cm) to a 6 cm section of both sides of abdominoplasty incision on one side of the midline and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997355|NCT01037985|OG000|Outcome|EXC 001 (PF-0647387) During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997356|NCT01037985|OG001|Outcome|Placebo During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997357|NCT01037985|OG000|Outcome|EXC 001 (PF-0647387) During Part A|In Part A participants received single intradermal injections on lower back of EXC 001 at a dose of 5 mg on Day 1 and 21. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery in Part B.
10997358|NCT01037985|OG001|Outcome|EXC 001 (PF-0647387) + Placebo During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
10997359|NCT01037985|OG000|Outcome|EXC 001 (PF-0647387) During Part A|In Part A participants received 2 intradermal injections on lower back of EXC 001 at a dose of 5 mg on Day 1 and 21. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery in Part B.
10997360|NCT01037985|EG000|Reported Event|EXC 001 (PF-0647387) During Part A|In Part A participants received 2 intradermal injections on lower back of EXC 001 at a dose of 5 mg on Day 1 and 21. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery in Part B.
10997361|NCT01037985|EG001|Reported Event|Active Dosing Phase During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed. Active dosing phase was from Week 2 to Week 13.
10997362|NCT01037985|EG002|Reported Event|Post Dosing Phase During Part B|Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
10997363|NCT01038128|BG000|Baseline|Memantine|Memantine, 10-40 mg daily
10997364|NCT01038128|FG000|Participant Flow|Memantine|Memantine, 10-40 mg daily
10997365|NCT01038128|OG000|Outcome|Memantine|Number of Binge Eating and Purging Episodes at Baseline and Endpoint
10997366|NCT01038128|OG000|Outcome|Memantine|Ratings at Baseline and Endpoint
10845167|NCT00265395|OG001|Outcome|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
10997367|NCT01038128|OG000|Outcome|Baseline Data|Ratings at Baseline and Endpoint.
10997368|NCT01038128|EG000|Reported Event|Memantine|Memantine, 10-40 mg daily
10997369|NCT01038297|BG000|Baseline|Cohort 1: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 mg on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
11007607|NCT01091948|OG000|Outcome|Active Comparator: Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
11007608|NCT01091948|OG001|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
10997370|NCT01038297|BG001|Baseline|Cohort 2: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997371|NCT01038297|BG002|Baseline|Cohort 3: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997372|NCT01038297|BG003|Baseline|Total|Total of all reporting groups
10997373|NCT01038297|FG000|Participant Flow|Cohort 1: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997374|NCT01038297|FG001|Participant Flow|Cohort 2: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997375|NCT01038297|FG002|Participant Flow|Cohort 3: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997376|NCT01038297|OG000|Outcome|Part B: Cohort 1: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo|Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.
10997377|NCT01038297|OG001|Outcome|Part B: Cohort 1: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo|Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.
10997378|NCT01038297|OG002|Outcome|Part B: Cohort 2: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo|Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.
10997379|NCT01038297|OG003|Outcome|Part B: Cohort 2: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo|Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.
11007609|NCT01091948|OG000|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
11007610|NCT01091948|EG000|Reported Event|Fiberoptic|Subjects will be intubated with the Fiberoptic laryngoscope.
10997380|NCT01038297|OG004|Outcome|Part B: Cohort 3: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo|Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.
10997381|NCT01038297|OG005|Outcome|Part B: Cohort 3: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo|Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.
10997382|NCT01038297|OG000|Outcome|Cohort 1: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 mg on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997383|NCT01038297|OG001|Outcome|Cohort 2: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997384|NCT01038297|OG002|Outcome|Cohort 3: EXC 001 and Placebo|In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997385|NCT01038297|EG000|Reported Event|Part A: Cohort 1: EXC 001|Participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study.
10997386|NCT01038297|EG001|Reported Event|Part A: Cohort 2: EXC 001|Participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study.
10997387|NCT01038297|EG002|Reported Event|Part A: Cohort 3: EXC 001|Participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study.
10997388|NCT01038297|EG003|Reported Event|Part B: Cohort 1: EXC 001 and Placebo|Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997389|NCT01038297|EG004|Reported Event|Part B: Cohort 2: EXC 001 and Placebo|Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
11007611|NCT01091948|EG001|Reported Event|GlideScope® Video Laryngoscope|Subjects will be intubated with the GlideScope® Video Laryngoscope
11007612|NCT01091974|BG000|Baseline|1 - CBT-I + Placebo|"CBT-I and placebo~Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
10845168|NCT00265395|EG000|Reported Event|Standard Therapy (48-week Treatment)|
10997390|NCT01038297|EG005|Reported Event|Part B: Cohort 3: EXC 001 and Placebo|Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
10997391|NCT01038323|BG000|Baseline|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
10997392|NCT01038323|BG001|Baseline|Milnacipran|Milnacipran (drug) only
10997393|NCT01038323|BG002|Baseline|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
10997394|NCT01038323|BG003|Baseline|Total|Total of all reporting groups
10997395|NCT01038323|FG000|Participant Flow|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
10997396|NCT01038323|FG001|Participant Flow|Milnacipran|Milnacipran (drug) only
10997397|NCT01038323|FG002|Participant Flow|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
10997398|NCT01038323|OG000|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
10997399|NCT01038323|OG001|Outcome|Milnacipran|Milnacipran (drug) only
10997400|NCT01038323|OG002|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
10997401|NCT01038323|EG000|Reported Event|Combination|Cognitive behavioral therapy + milnacipran
10997402|NCT01038323|EG001|Reported Event|Milnacipran|milnacipran + education
10997403|NCT01038323|EG002|Reported Event|Cognitive Behavioral Therapy|Cognitive behavioral therapy + placebo
10997404|NCT01038336|BG000|Baseline|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
10997405|NCT01038336|BG001|Baseline|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation brochure: The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
10997406|NCT01038336|BG002|Baseline|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
10997407|NCT01038336|BG003|Baseline|Total|Total of all reporting groups
10997408|NCT01038336|FG000|Participant Flow|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
10997409|NCT01038336|FG001|Participant Flow|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
10997410|NCT01038336|FG002|Participant Flow|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
10997411|NCT01038336|OG000|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
10997412|NCT01038336|OG001|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
10997413|NCT01038336|OG002|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
10997414|NCT01038336|OG000|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
10997415|NCT01038336|OG001|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
10997416|NCT01038336|OG002|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
10997417|NCT01038336|OG002|Outcome|Standard of Care|Standard of care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to.
10997418|NCT01038336|OG002|Outcome|Standard-of-Care|Standard-of-Care (SoC): Soc amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
10997419|NCT01038336|EG000|Reported Event|Multimedia Hearing Loss Prevention Program|Multimedia Hearing Loss Prevention Program (HLPP) is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
10997420|NCT01038336|EG001|Reported Event|Hearing Conservation Brochure|Hearing Conservation Brochure (HCB). Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
10997421|NCT01038336|EG002|Reported Event|Standard of Care|Standard of Care (SoC): SoC amounts ot no intervention although participants were allowed to seek information about hearing loss prevention if they wanted to.
10997422|NCT01038427|BG000|Baseline|Test|Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
10997423|NCT01038427|BG001|Baseline|Reference|Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
10997424|NCT01038427|BG002|Baseline|Placebo|Placebo nasal spray administered once daily for 14 days.
10845169|NCT00265473|BG000|Baseline|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
10997425|NCT01038427|BG003|Baseline|Total|Total of all reporting groups
10997426|NCT01038427|FG000|Participant Flow|Test|Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
10997427|NCT01038427|FG001|Participant Flow|Reference|Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
10997428|NCT01038427|FG002|Participant Flow|Placebo|Placebo nasal spray administered once daily for 14 days.
10997429|NCT01038427|OG000|Outcome|Test|Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
10997430|NCT01038427|OG001|Outcome|Reference|Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
10997431|NCT01038427|OG002|Outcome|Placebo|Placebo nasal spray administered once daily for 14 days.
10997432|NCT01038427|EG000|Reported Event|Test|Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
10997433|NCT01038427|EG001|Reported Event|Reference|Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
10997434|NCT01038427|EG002|Reported Event|Placebo|Placebo nasal spray administered once daily for 14 days.
10997435|NCT01038557|BG000|Baseline|Refrigerated RBCs 0-14 Days Old|"Standard, refrigerated RBC units stored up to 14 days~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997436|NCT01038557|BG001|Baseline|Refrigerated RBCs 15-42 Days Old|"Standard, refrigerated RBC units stored 15-42 days~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997437|NCT01038557|BG002|Baseline|Frozen RBCs|"RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997438|NCT01038557|BG003|Baseline|Total|Total of all reporting groups
10997439|NCT01038557|FG000|Participant Flow|Refrigerated RBCs 0-14 Days Old|"Standard, refrigerated RBC units stored up to 14 days~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997440|NCT01038557|FG001|Participant Flow|Refrigerated RBCs 15-42 Days Old|"Standard, refrigerated RBC units stored 15-42 days~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997441|NCT01038557|FG002|Participant Flow|Frozen RBCs|"RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997442|NCT01038557|OG000|Outcome|Refrigerated RBCs 0-14 Days Old|"Standard, refrigerated RBC units stored up to 14 days~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10845170|NCT00265473|FG000|Participant Flow|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
10845171|NCT00265473|OG000|Outcome|Experimental|Islet infusion
10997443|NCT01038557|OG001|Outcome|Refrigerated RBCs 15-42 Days Old|"Standard, refrigerated RBC units stored 15-42 days~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997444|NCT01038557|OG002|Outcome|Frozen RBCs|"RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997445|NCT01038557|EG000|Reported Event|Refrigerated RBCs 0-14 Days Old|"Standard, refrigerated RBC units stored up to 14 days~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997446|NCT01038557|EG001|Reported Event|Refrigerated RBCs 15-42 Days Old|"Standard, refrigerated RBC units stored 15-42 days~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997447|NCT01038557|EG002|Reported Event|Frozen RBCs|"RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.~RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored."
10997448|NCT01038609|BG000|Baseline|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
10997449|NCT01038609|BG001|Baseline|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997450|NCT01038609|BG002|Baseline|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
10997451|NCT01038609|BG003|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997452|NCT01038609|BG004|Baseline|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997453|NCT01038609|BG005|Baseline|Total|Total of all reporting groups
10997454|NCT01038609|FG000|Participant Flow|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
10997455|NCT01038609|FG001|Participant Flow|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997456|NCT01038609|FG002|Participant Flow|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
10997457|NCT01038609|FG003|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997458|NCT01038609|FG004|Participant Flow|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997459|NCT01038609|OG000|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
10997460|NCT01038609|OG001|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997461|NCT01038609|OG002|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
10997462|NCT01038609|OG003|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997463|NCT01038609|OG004|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997464|NCT01038609|EG000|Reported Event|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
10997465|NCT01038609|EG001|Reported Event|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997466|NCT01038609|EG002|Reported Event|Morphine Extended Release/Acetaminophen|1 dose of 1 morphine extended release capsule and 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
10997467|NCT01038609|EG003|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997468|NCT01038609|EG004|Reported Event|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
10997469|NCT01038635|BG000|Baseline|5-AZA + LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days
10997470|NCT01038635|BG001|Baseline|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days
10997471|NCT01038635|BG002|Baseline|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
10997472|NCT01038635|BG003|Baseline|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
10997473|NCT01038635|BG004|Baseline|5-AZA + 50 LEN|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
10997474|NCT01038635|BG005|Baseline|5-AZA + LEN 75 mg 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
10997475|NCT01038635|BG006|Baseline|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
10997476|NCT01038635|BG007|Baseline|Phase II: 5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
10997477|NCT01038635|BG008|Baseline|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
10997478|NCT01038635|BG009|Baseline|Total|Total of all reporting groups
10997479|NCT01038635|FG000|Participant Flow|5-AZA + LEN 10 mg|Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
10997480|NCT01038635|FG001|Participant Flow|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
10997481|NCT01038635|FG002|Participant Flow|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
10997482|NCT01038635|FG003|Participant Flow|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
10997483|NCT01038635|FG004|Participant Flow|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
10997484|NCT01038635|FG005|Participant Flow|5-AZA + LEN 75 mg for 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
10997485|NCT01038635|FG006|Participant Flow|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
10997486|NCT01038635|FG007|Participant Flow|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
10997487|NCT01038635|FG008|Participant Flow|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
10997488|NCT01038635|OG000|Outcome|5-AZA + 5 Days LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
10997489|NCT01038635|OG001|Outcome|5-AZA + 5 Days LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
10997490|NCT01038635|OG002|Outcome|5-AZA + 5 Days LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
10997491|NCT01038635|OG003|Outcome|5-AZA + 5 Days LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
10997492|NCT01038635|OG004|Outcome|5-AZA + 5 Days LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
10997493|NCT01038635|OG005|Outcome|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
11223807|NCT02355821|OG000|Outcome|Moxonidine|"0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID~Moxonidine: 0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID Other Names:perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D"
11223808|NCT02355821|OG001|Outcome|Bisoprolol|"5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID~Bisoprolol: 5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID Other Names: perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D"
11223809|NCT02355821|EG000|Reported Event|Moxonidine|"0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID~Moxonidine: 0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID Other Names:perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D"
11223810|NCT02355821|EG001|Reported Event|Bisoprolol|"5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID~Bisoprolol: 5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID Other Names: perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D"
11223811|NCT02355886|BG000|Baseline|Arm I (Gabapentin)|"Patients receive gabapentin PO TID for 48 hours after surgery.~Gabapentin: Given PO~Questionnaire Administration: Ancillary studies"
10997494|NCT01038635|OG006|Outcome|5-AZA + 10 Days LEN 75 mg 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
10997495|NCT01038635|OG000|Outcome|Phase I: 5-AZA + LEN MTD|5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
10997496|NCT01038635|OG001|Outcome|Phase II: 5-AZA + LEN|All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg was administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
10997497|NCT01038635|OG000|Outcome|Overall Study: 5-AZA + LEN MTD|Combined reporting for all phases, Phase I (5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10) and Phase II All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
10997498|NCT01038635|EG000|Reported Event|5-AZA + LEN 10 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
10997499|NCT01038635|EG001|Reported Event|5-AZA + LEN 15 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
10997500|NCT01038635|EG002|Reported Event|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
11223812|NCT02355886|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO TID for 48 hours after surgery.~Placebo: Given PO~Questionnaire Administration: Ancillary studies"
11223813|NCT02355886|BG002|Baseline|Total|Total of all reporting groups
10997501|NCT01038635|EG003|Reported Event|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
11223814|NCT02355886|FG000|Participant Flow|Arm I (Gabapentin)|"Patients receive gabapentin PO TID for 48 hours after surgery.~Gabapentin: Given PO~Questionnaire Administration: Ancillary studies"
10997502|NCT01038635|EG004|Reported Event|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
10997503|NCT01038635|EG005|Reported Event|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
10997504|NCT01038635|EG006|Reported Event|5-AZA + 10 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
10997505|NCT01038635|EG007|Reported Event|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
10997506|NCT01038635|EG008|Reported Event|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
10997507|NCT01038687|BG000|Baseline|A3309 15 mg|"Patients randomized to this arm received one oral tablet daily of 15 mg A3309 for a period of 14 consecutive days.~A3309: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets"
11223815|NCT02355886|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO TID for 48 hours after surgery.~Placebo: Given PO~Questionnaire Administration: Ancillary studies"
11223816|NCT02355886|OG000|Outcome|Arm I (Gabapentin)|"Patients receive gabapentin PO TID for 48 hours after surgery.~Gabapentin: Given PO~Questionnaire Administration: Ancillary studies"
11223817|NCT02355886|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO TID for 48 hours after surgery.~Placebo: Given PO~Questionnaire Administration: Ancillary studies"
11223818|NCT02355886|EG000|Reported Event|Arm I (Gabapentin)|"Patients receive gabapentin PO TID for 48 hours after surgery.~Gabapentin: Given PO~Questionnaire Administration: Ancillary studies"
11223819|NCT02355886|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO TID for 48 hours after surgery.~Placebo: Given PO~Questionnaire Administration: Ancillary studies"
11336465|NCT03566823|OG000|Outcome|Placebo|Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10997508|NCT01038687|BG001|Baseline|A3309 20 mg|"Patients randomized to this arm received one oral tablet daily of 20 mg A3309 for a period of 14 consecutive days.~A3309: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets"
10997509|NCT01038687|BG002|Baseline|Placebo|"Patients randomized to this arm received one oral tablet daily of a matching placebo for a period of 14 consecutive days.~placebo: placebo"
10845172|NCT00265473|OG000|Outcome|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
10845173|NCT00265473|EG000|Reported Event|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
10845174|NCT00265512|BG000|Baseline|Telephone Case Monitoring Aftercare|Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
10845175|NCT00265512|BG001|Baseline|Continuing Care as Usual|Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
10997510|NCT01038687|BG003|Baseline|Total|Total of all reporting groups
10997511|NCT01038687|FG000|Participant Flow|A3309 15 mg|"Patients randomized to this arm received one oral tablet daily of 15 mg A3309 for a period of 14 consecutive days.~A3309: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets"
10997512|NCT01038687|FG001|Participant Flow|A3309 20 mg|"Patients randomized to this arm received one oral tablet daily of 20 mg A3309 for a period of 14 consecutive days.~A3309: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets"
10997513|NCT01038687|FG002|Participant Flow|Placebo|"Patients randomized to this arm received one oral tablet daily of a matching placebo for a period of 14 consecutive days.~placebo: placebo"
10997514|NCT01038687|OG000|Outcome|A3309 15 mg|"Patients randomized to this arm received one oral tablet daily of 15 mg A3309 for a period of 14 consecutive days.~A3309: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets"
10997515|NCT01038687|OG001|Outcome|A3309 20 mg|"Patients randomized to this arm received one oral tablet daily of 20 mg A3309 for a period of 14 consecutive days.~A3309: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets"
10997516|NCT01038687|OG002|Outcome|Placebo|"Patients randomized to this arm received one oral tablet daily of a matching placebo for a period of 14 consecutive days.~placebo: placebo"
10997517|NCT01038687|EG000|Reported Event|A3309 15 mg|"Patients randomized to this arm received one oral tablet daily of 15 mg A3309 for a period of 14 consecutive days.~A3309: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets"
10997518|NCT01038687|EG001|Reported Event|A3309 20 mg|"Patients randomized to this arm received one oral tablet daily of 20 mg A3309 for a period of 14 consecutive days.~A3309: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets"
10997519|NCT01038687|EG002|Reported Event|Placebo|"Patients randomized to this arm received one oral tablet daily of a matching placebo for a period of 14 consecutive days.~placebo: placebo"
10997520|NCT01038713|BG000|Baseline|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997521|NCT01038713|BG001|Baseline|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
11223820|NCT02355977|BG000|Baseline|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
11223821|NCT02355977|BG001|Baseline|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
10997522|NCT01038713|BG002|Baseline|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997523|NCT01038713|BG003|Baseline|Total|Total of all reporting groups
10997524|NCT01038713|FG000|Participant Flow|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997525|NCT01038713|FG001|Participant Flow|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997526|NCT01038713|FG002|Participant Flow|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997527|NCT01038713|OG000|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997528|NCT01038713|OG001|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
11223822|NCT02355977|BG002|Baseline|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
11223823|NCT02355977|BG003|Baseline|Total|Total of all reporting groups
11336466|NCT03566823|OG001|Outcome|Ontamalimab 25 mg|Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10845176|NCT00265512|BG002|Baseline|Total|Total of all reporting groups
10845177|NCT00265512|FG000|Participant Flow|Telephone Case Monitoring Aftercare|Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
10845178|NCT00265512|FG001|Participant Flow|Continuing Care as Usual|Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
10845179|NCT00265512|OG000|Outcome|Telephone Case Monitoring Aftercare|Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
10845180|NCT00265512|OG001|Outcome|Continuing Care as Usual|Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
10845181|NCT00265512|EG000|Reported Event|Telephone Case Monitoring Aftercare|"Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.~SAEs were tracked, but AEs were not tracked."
10845182|NCT00265512|EG001|Reported Event|Continuing Care as Usual|"Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.~SAEs were tracked, but AEs were not tracked."
10845183|NCT00265538|BG000|Baseline|Control Group|No intervention (usual care)
10845184|NCT00265538|BG001|Baseline|Combined Intervention Groups|Patient Intervention Arms: Group A (intervention letter only); Group B (intervention, + financial incentive for discussion w/ provider and 6 month copay reimbursement); Group C (intervention letter, financial incentive for discussion w/ provider + copay reimbursement, plus reminder phone call 1-3 days prior to primary care visit)
10845185|NCT00265538|BG002|Baseline|Total|Total of all reporting groups
10845186|NCT00265538|FG000|Participant Flow|Intervention Group A|Group a (intervention letter only): Patients will receive a customized/tailored letter including most recent clinic blood pressure, current blood pressure medications, and suggested blood pressure medication(s). The letter also encouraged the patient to discuss their blood pressure treatment with their provider.
10845187|NCT00265538|FG001|Participant Flow|Intervention Group B|Group B: intervention letter from Group A + $20 financial incentive for discussion with the provider and 6 month copay reimbursement if the patient has a copay.
10845188|NCT00265538|FG002|Participant Flow|Intervention Group C|Group C: Intervention letter from Group A + financial incentive from Group B + health educator phone call. The phone call 1-2 days prior to their primary care appointment encouraged them to talk with their provider about their blood pressure treatment.
10845189|NCT00265538|FG003|Participant Flow|Control Group|The control group received usual care. They were given informed consent that they could either be in the intervention or control groups.
10845190|NCT00265538|OG000|Outcome|Intervention Group A|Group A (intervention letter only)
10845191|NCT00265538|OG001|Outcome|Intervention Group B|Intervention Letter + financial incentive
10845192|NCT00265538|OG002|Outcome|Intervention Group C|Intervention letter + financial incentive + phone call
10845193|NCT00265538|OG003|Outcome|Control Group|Usual care
10845194|NCT00265538|OG000|Outcome|Intervention Group A|Group a (intervention letter only): Patients will receive a customized/tailored letter including most recent clinic blood pressure, current blood pressure medications, and suggested blood pressure medication(s). The letter also encouraged the patient to discuss their blood pressure treatment with their provider.
10845195|NCT00265538|OG001|Outcome|Intervention Group B|Group B: intervention letter from Group A + $20 financial incentive for discussion with the provider and 6 month copay reimbursement if the patient has a copay.
10845196|NCT00265538|OG002|Outcome|Intervention Group C|Group C: Intervention letter from Group A + financial incentive from Group B + health educator phone call. The phone call 1-2 days prior to their primary care appointment encouraged them to talk with their provider about their blood pressure treatment.
10845197|NCT00265538|OG003|Outcome|Control Group|The control group received usual care. They were given informed consent that they could either be in the intervention or control groups.
10845198|NCT00265538|EG000|Reported Event|Control Group|No intervention (usual care)
10845199|NCT00265538|EG001|Reported Event|Combined Intervention Groups|Patient Intervention Arms: Group A (intervention letter only); Group B (intervention, + financial incentive for discussion w/ provider and 6 month copay reimbursement); Group C (intervention letter, financial incentive for discussion w/ provider + copay reimbursement, plus reminder phone call 1-3 days prior to primary care visit)blood pressure, current blood pressure medications and suggested htn medication(s)
10845200|NCT00265564|BG000|Baseline|Seeking Safety|"Seeking Safety is a manualized, empirically supported, cognitive behavioral therapy that treats substance use disorders and comorbid PTSD. Participants assigned to the Seeking Safety arm attend two one hour sessions of group therapy for 12 weeks.~Modified Seeking Safety integrated into std outpatient SUD care: The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks."
10845201|NCT00265564|BG001|Baseline|Usual Care|"Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.~Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence."
10845202|NCT00265564|BG002|Baseline|Total|Total of all reporting groups
10845203|NCT00265564|FG000|Participant Flow|Seeking Safety|"Seeking Safety is a manualized, empirically supported, cognitive behavioral therapy that treats substance use disorders and comorbid PTSD. Participants assigned to the Seeking Safety arm attend two one hour sessions of group therapy for 12 weeks.~Modified Seeking Safety integrated into std outpatient SUD care: The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks."
10997529|NCT01038713|OG002|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997530|NCT01038713|EG000|Reported Event|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997531|NCT01038713|EG001|Reported Event|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997532|NCT01038713|EG002|Reported Event|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
10997533|NCT01038856|BG000|Baseline|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
10997534|NCT01038856|FG000|Participant Flow|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
10997535|NCT01038856|OG000|Outcome|Single Arm Study|This was a single arm study
10997536|NCT01038856|OG000|Outcome|Erlotinib|150 mg po daily x 16 weeks
10997537|NCT01038856|OG000|Outcome|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
10997538|NCT01038856|EG000|Reported Event|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
10997539|NCT01038869|BG000|Baseline|Finacea|Open label pilot study
10997540|NCT01038869|FG000|Participant Flow|Finacea|Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.
10997541|NCT01038869|OG000|Outcome|Azelaic Acid 15% Open Label|Assessments of IGA
10997542|NCT01038869|OG000|Outcome|Azelaic Acis 15% Open Label|Assessments of PIH IGA
10997543|NCT01038869|OG000|Outcome|Azelaic Acid 15%|
10997544|NCT01038869|OG000|Outcome|Azelaic Acid 15%|lesion counts
10997545|NCT01038869|OG000|Outcome|Azelaic Acid 15%|tolerability assessments
10997546|NCT01038869|EG000|Reported Event|Finacea|Open label pilot study
10997547|NCT01038921|BG000|Baseline|Melatonin First|Cross-over design with subjects receiving Melatonin First
10997548|NCT01038921|BG001|Baseline|Placebo First|Cross-over design with subjects receiving Placebo First
10997549|NCT01038921|BG002|Baseline|Total|Total of all reporting groups
11223824|NCT02355977|FG000|Participant Flow|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
10997550|NCT01038921|FG000|Participant Flow|Melatonin|Cross-over design with subject receiving either Melatonin First and Placebo Second or Placebo First and Melatonin Second
10997551|NCT01038921|FG001|Participant Flow|Placebo|Cross-over design with subjects receiving either Placebo First and Melatonin Second or Melatonin First and Placebo Second
10997552|NCT01038921|OG000|Outcome|Melatonin|Cross-over design for subjects on Melatonin for 10 weeks measured at baseline and 10 weeks
10997553|NCT01038921|OG001|Outcome|Placebo|Cross-over design for all subjects on Placebo for 10 weeks measured at baseline and at 10 weeks.
10997554|NCT01038921|EG000|Reported Event|Melatonin First|Cross-over design for subjects randomized to Melatonin First, Placebo Second
10997555|NCT01038921|EG001|Reported Event|Placebo First|Cross-over design for subjects randomized to Placebo First, Melatonin Second
10997556|NCT01039207|BG000|Baseline|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
10997557|NCT01039207|FG000|Participant Flow|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
10997558|NCT01039207|OG000|Outcome|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
10997559|NCT01039207|EG000|Reported Event|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
10997560|NCT01039376|BG000|Baseline|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
10997561|NCT01039376|BG001|Baseline|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
10997562|NCT01039376|BG002|Baseline|Total|Total of all reporting groups
10997563|NCT01039376|FG000|Participant Flow|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
10997564|NCT01039376|FG001|Participant Flow|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
10997565|NCT01039376|OG000|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
10997566|NCT01039376|OG001|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
10997567|NCT01039376|EG000|Reported Event|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
10997568|NCT01039376|EG001|Reported Event|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
10997569|NCT01039376|EG002|Reported Event|Total|All patients
10997570|NCT01039428|BG000|Baseline|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
10997571|NCT01039428|BG001|Baseline|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
10997572|NCT01039428|BG002|Baseline|Total|Total of all reporting groups
10997573|NCT01039428|FG000|Participant Flow|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
10997574|NCT01039428|FG001|Participant Flow|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
10997575|NCT01039428|OG000|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
10997576|NCT01039428|OG001|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
10997577|NCT01039428|EG000|Reported Event|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
10997578|NCT01039428|EG001|Reported Event|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
10997579|NCT01039467|BG000|Baseline|Managed Ventricular Pacing (MVP)|Managed Ventricular Pacing (MVP) used in dual chamber pacemaker
11223825|NCT02355977|FG001|Participant Flow|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
11223826|NCT02355977|FG002|Participant Flow|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
11223827|NCT02355977|OG000|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
10997580|NCT01039467|BG001|Baseline|Search AV+|Search AV+ used in dual chamber pacemaker
10997581|NCT01039467|BG002|Baseline|Total|Total of all reporting groups
10997582|NCT01039467|FG000|Participant Flow|Managed Ventricular Pacing (MVP)|Managed Ventricular Pacing (MVP) used in dual chamber pacemaker
10997583|NCT01039467|FG001|Participant Flow|Search AV+|Search AV+ used in dual chamber pacemaker
10997584|NCT01039467|OG000|Outcome|Managed Ventricular Pacing|Managed Ventricular Pacing (MVP)
10997585|NCT01039467|OG001|Outcome|Search AV+|Search AV+ (SAV+)
10997586|NCT01039467|OG000|Outcome|No AV Block|Patients with no atrioventricular block
10997587|NCT01039467|OG001|Outcome|nAVB|Patients with atrioventricular block
10997588|NCT01039467|EG000|Reported Event|Managed Ventricular Pacing|Managed Ventricular Pacing (MVP)
11223828|NCT02355977|OG001|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
10997589|NCT01039467|EG001|Reported Event|Search AV+|Search AV+ (SAV+)
10997590|NCT01039519|BG000|Baseline|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
10997591|NCT01039519|FG000|Participant Flow|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
10997592|NCT01039519|OG000|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
10997593|NCT01039519|EG000|Reported Event|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
10997594|NCT01039584|BG000|Baseline|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
10997595|NCT01039584|BG001|Baseline|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
10997596|NCT01039584|BG002|Baseline|Placebo|"vehicle of the test product~Placebo : vaginal cream"
10997597|NCT01039584|BG003|Baseline|Total|Total of all reporting groups
10997598|NCT01039584|FG000|Participant Flow|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
10997599|NCT01039584|FG001|Participant Flow|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
10997600|NCT01039584|FG002|Participant Flow|Placebo|"vehicle of the test product~Placebo : vaginal cream"
10997601|NCT01039584|OG000|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
10997602|NCT01039584|OG001|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
10997603|NCT01039584|OG002|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
10997604|NCT01039584|EG000|Reported Event|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
10997605|NCT01039584|EG001|Reported Event|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
11223829|NCT02355977|OG002|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
11223830|NCT02355977|EG000|Reported Event|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
11223831|NCT02355977|EG001|Reported Event|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
11223832|NCT02355977|EG002|Reported Event|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
11223833|NCT02356003|BG000|Baseline|Low Frequency rTMS|"Eleven children (7-12 years of age) with Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation (5 times a week for three weeks).~Low frequency repetitive transcranial magnetic stimulation: Baseline high-resolution anatomical magnetic resonance images will allow individualized neuronavigation (Brainsight 2, Rogue Research, Montreal QC) to co-register the transcranial magnetic stimulation Airfilm coil (Magistim, UK) precisely to the supplementary motor area as defined by functional magnetic resonance imaging. Interventional low frequency repetitive transcranial magnetic stimulation parameters will be: intensity 100% resting motor threshold, frequency 1 Hz, duration = 20 minutes (1200 stimulations). Treatments will occur on each weekday at the same time of day for three weeks (15 total). These are standard parameters for low frequency repetitive transcranial magnetic stimulation and are well tolerated in children."
11223834|NCT02356003|FG000|Participant Flow|Low Frequency rTMS|"Ten children (7-12 years of age) with Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation (5 times a week for three weeks).~Low frequency repetitive transcranial magnetic stimulation: Baseline high-resolution anatomical magnetic resonance images will allow individualized neuronavigation (Brainsight 2, Rogue Research, Montreal QC) to co-register the transcranial magnetic stimulation Airfilm coil (Magistim, UK) precisely to the supplementary motor area as defined by functional magnetic resonance imaging. Interventional low frequency repetitive transcranial magnetic stimulation parameters will be: intensity 100% resting motor threshold, frequency 1 Hz, duration = 20 minutes (1200 stimulations). Treatments will occur on each weekday at the same time of day for three weeks (15 total). These are standard parameters for low frequency repetitive transcranial magnetic stimulation and are well tolerated in children."
11223835|NCT02356003|OG000|Outcome|Low Frequency rTMS|"Eleven children (7-12 years of age) with Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation (5 times a week for three weeks).~Low frequency repetitive transcranial magnetic stimulation: Baseline high-resolution anatomical magnetic resonance images will allow individualized neuronavigation (Brainsight 2, Rogue Research, Montreal QC) to co-register the transcranial magnetic stimulation Airfilm coil (Magistim, UK) precisely to the supplementary motor area as defined by functional magnetic resonance imaging. Interventional low frequency repetitive transcranial magnetic stimulation parameters will be: intensity 100% resting motor threshold, frequency 1 Hz, duration = 20 minutes (1200 stimulations). Treatments will occur on each weekday at the same time of day for three weeks (15 total). These are standard parameters for low frequency repetitive transcranial magnetic stimulation and are well tolerated in children."
11223836|NCT02356003|OG000|Outcome|Low Frequency rTMS|"Ten children (7-12 years of age) with Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation (5 times a week for three weeks).~Low frequency repetitive transcranial magnetic stimulation: Baseline high-resolution anatomical magnetic resonance images will allow individualized neuronavigation (Brainsight 2, Rogue Research, Montreal QC) to co-register the transcranial magnetic stimulation Airfilm coil (Magistim, UK) precisely to the supplementary motor area as defined by functional magnetic resonance imaging. Interventional low frequency repetitive transcranial magnetic stimulation parameters will be: intensity 100% resting motor threshold, frequency 1 Hz, duration = 20 minutes (1200 stimulations). Treatments will occur on each weekday at the same time of day for three weeks (15 total). These are standard parameters for low frequency repetitive transcranial magnetic stimulation and are well tolerated in children."
11224526|NCT02360488|OG001|Outcome|In-Clinic Therapy|"The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education.~In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions."
10845204|NCT00265564|FG001|Participant Flow|Usual Care|"Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.~Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence."
10997606|NCT01039584|EG002|Reported Event|Placebo|"vehicle of the test product~Placebo : vaginal cream"
10997607|NCT01039675|BG000|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
10997608|NCT01039675|BG001|Baseline|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
10997609|NCT01039675|BG002|Baseline|Total|Total of all reporting groups
10997610|NCT01039675|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 4 weeks.
10997611|NCT01039675|FG001|Participant Flow|UMEC/VI 500/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 500/25 micrograms (µg) QD via a DPI in the morning for 4 weeks.
10997612|NCT01039675|OG000|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
10997613|NCT01039675|OG001|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
10997614|NCT01039675|EG000|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
10997615|NCT01039675|EG001|Reported Event|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
10997616|NCT01039688|BG000|Baseline|CP-690,550 5 mg Twice Daily (BID)|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
10997617|NCT01039688|BG001|Baseline|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
10997618|NCT01039688|BG002|Baseline|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
11223837|NCT02356003|EG000|Reported Event|Low Frequency rTMS|"Eleven children (7-12 years of age) with Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation (5 times a week for three weeks).~Low frequency repetitive transcranial magnetic stimulation: Baseline high-resolution anatomical magnetic resonance images will allow individualized neuronavigation (Brainsight 2, Rogue Research, Montreal QC) to co-register the transcranial magnetic stimulation Airfilm coil (Magistim, UK) precisely to the supplementary motor area as defined by functional magnetic resonance imaging. Interventional low frequency repetitive transcranial magnetic stimulation parameters will be: intensity 100% resting motor threshold, frequency 1 Hz, duration = 20 minutes (1200 stimulations). Treatments will occur on each weekday at the same time of day for three weeks (15 total). These are standard parameters for low frequency repetitive transcranial magnetic stimulation and are well tolerated in children."
11223838|NCT02356107|BG000|Baseline|Open Label Treatment With 5-HTP and Creatine|5-hydroxytryptophan and Creatine monohydrate
11223839|NCT02356107|FG000|Participant Flow|Open Label Treatment With 5-HTP and Creatine|5-hydroxytryptophan and Creatine monohydrate
10997619|NCT01039688|BG003|Baseline|Total|Total of all reporting groups
10997620|NCT01039688|FG000|Participant Flow|CP-690,550 5 mg Twice Daily (BID)|Participants received CP-690,550 5 milligram (mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo methotrexate (MTX) capsules, orally, once per week, for up to 24 months.
10997621|NCT01039688|FG001|Participant Flow|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
10997622|NCT01039688|FG002|Participant Flow|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
10997623|NCT01039688|OG000|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
10997624|NCT01039688|OG001|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
10997625|NCT01039688|OG002|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
10997626|NCT01039688|OG000|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
10997627|NCT01039688|OG002|Outcome|MTX 10, 15 or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
10997628|NCT01039688|OG002|Outcome|MTX 10,15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
10997629|NCT01039688|EG000|Reported Event|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
10997630|NCT01039688|EG001|Reported Event|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
10997631|NCT01039688|EG002|Reported Event|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
10997632|NCT01039792|BG000|Baseline|Placebo|"Placebo~Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid"
10997633|NCT01039792|BG001|Baseline|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
10997634|NCT01039792|BG002|Baseline|Total|Total of all reporting groups
10997635|NCT01039792|FG000|Participant Flow|Placebo|"Placebo~Placebo: placebo"
10997636|NCT01039792|FG001|Participant Flow|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
10997637|NCT01039792|OG000|Outcome|Placebo|"Placebo~Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid"
10997638|NCT01039792|OG001|Outcome|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
10997639|NCT01039792|EG000|Reported Event|Placebo|"Placebo~Placebo: placebo"
10997640|NCT01039792|EG001|Reported Event|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
10997641|NCT01040052|BG000|Baseline|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
10997642|NCT01040052|FG000|Participant Flow|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
10997643|NCT01040052|OG000|Outcome|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
10997644|NCT01040052|EG000|Reported Event|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
10997645|NCT01040130|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
10997646|NCT01040130|FG000|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
10997647|NCT01040130|FG001|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
10997648|NCT01040130|FG002|Participant Flow|Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
10997649|NCT01040130|FG003|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
10997650|NCT01040130|FG004|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
11223840|NCT02356107|OG000|Outcome|Open Label Treatment With 5-HTP and Creatine|5-hydroxytryptophan and Creatine monohydrate
10997651|NCT01040130|FG005|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
10997652|NCT01040130|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10997653|NCT01040130|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
10997654|NCT01040130|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
10997655|NCT01040130|OG001|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997656|NCT01040130|OG002|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997657|NCT01040130|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10997658|NCT01040130|EG001|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997659|NCT01040130|EG002|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997660|NCT01040169|BG000|Baseline|Nupro C Prophylaxis Paste|
10997661|NCT01040169|BG001|Baseline|ProClude Prophylaxis Paste|
10997662|NCT01040169|BG002|Baseline|Total|Total of all reporting groups
10997663|NCT01040169|FG000|Participant Flow|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
10997664|NCT01040169|FG001|Participant Flow|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
10997665|NCT01040169|OG000|Outcome|Nupro C Prophylaxis Paste|
10997666|NCT01040169|OG001|Outcome|ProClude Prophylaxis Paste|
10997667|NCT01040169|EG000|Reported Event|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
10997668|NCT01040169|EG001|Reported Event|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
10997669|NCT01040208|BG000|Baseline|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
10997670|NCT01040208|BG001|Baseline|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
10997671|NCT01040208|BG002|Baseline|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
10997672|NCT01040208|BG003|Baseline|Total|Total of all reporting groups
10997673|NCT01040208|FG000|Participant Flow|Flibanserin 50 mg to 100 mg Qhs (Take Daily, at Bedtime)|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
10997674|NCT01040208|FG001|Participant Flow|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
10997675|NCT01040208|FG002|Participant Flow|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
10997676|NCT01040208|OG000|Outcome|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
10997677|NCT01040208|OG001|Outcome|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
10997678|NCT01040208|OG002|Outcome|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
10997679|NCT01040208|OG000|Outcome|Flibanserin 50 mg to 100 mg Qhs|
11223841|NCT02356107|EG000|Reported Event|Open Label Treatment With 5-HTP and Creatine|5-hydroxytryptophan and Creatine monohydrate
11223842|NCT02356198|BG000|Baseline|TAP Block (EXPAREL)|"After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.~EXPAREL: transversus abdominis plane injection"
11223843|NCT02356198|BG001|Baseline|Intrathecal Opioid (IT)|"single injection intrathecal hydromorphone analgesia given preoperatively~Intrathecal hydromorphone: Intrathecal opioid administration"
11223844|NCT02356198|BG002|Baseline|Total|Total of all reporting groups
11223845|NCT02356198|FG000|Participant Flow|TAP Block (EXPAREL)|"After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.~EXPAREL: transversus abdominis plane injection"
11223846|NCT02356198|FG001|Participant Flow|Intrathecal Opioid (IT)|"single injection intrathecal hydromorphone analgesia given preoperatively~Intrathecal hydromorphone: Intrathecal opioid administration"
11223847|NCT02356198|OG000|Outcome|TAP Block (EXPAREL)|"After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.~EXPAREL: transversus abdominis plane injection"
11223848|NCT02356198|OG001|Outcome|Intrathecal Opioid (IT)|"single injection intrathecal hydromorphone analgesia given preoperatively~Intrathecal hydromorphone: Intrathecal opioid administration"
11223849|NCT02356198|EG000|Reported Event|TAP Block (EXPAREL)|"After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.~EXPAREL: transversus abdominis plane injection"
11223850|NCT02356198|EG001|Reported Event|Intrathecal Opioid (IT)|"single injection intrathecal hydromorphone analgesia given preoperatively~Intrathecal hydromorphone: Intrathecal opioid administration"
10997680|NCT01040208|OG001|Outcome|Flibanserin 100 mg Qhs|
10997681|NCT01040208|OG002|Outcome|Placebo 2 Tablets Qhs|
11223851|NCT02356211|BG000|Baseline|Treatment|"Geriatric Multifactorial Falls Assessment Clinic~Multifactorial Falls Assessment: The Geriatric Multifactorial Falls Assessment Clinic is a component of GERIACTRIC-PACT, a frail-elderly primary care patient-centered medical home with care provided by an inter-professional teamlet consisting of a geriatrician, geriatric nurse practitioner, clinical pharmacist, licensed practical nurse, nurse care manager, social worker, and dietitian. GERIATRIC-PACT operates with increased ancillary support compared to Primary Care PACT. Falls assessment patients were referred by primary care providers and were evaluated and treated by the GERIATRIC-PACT teamlet, including ordering of tests and medication adjustment, with an average of two visits and active follow-up for one year."
11223852|NCT02356211|BG001|Baseline|Control|Geriatric Evaluation and Management Service (GEM) The Geriatric Evaluation and Management Service (GEM) is an acute inpatient service with over 150 discharges annually. Frail elderly treated on GEM receive inter-professional geriatric team assessment and treatment while hospitalized. Patients discharged to home return to the care of their primary physicians.
11223853|NCT02356211|BG002|Baseline|Total|Total of all reporting groups
11223854|NCT02356211|FG000|Participant Flow|Treatment|"Geriatric Multifactorial Falls Assessment Clinic~Multifactorial Falls Assessment: The Geriatric Multifactorial Falls Assessment Clinic is a component of GERIACTRIC-PACT, a frail-elderly primary care patient-centered medical home with care provided by an inter-professional teamlet consisting of a geriatrician, geriatric nurse practitioner, clinical pharmacist, licensed practical nurse, nurse care manager, social worker, and dietitian. GERIATRIC-PACT operates with increased ancillary support compared to Primary Care PACT. Falls assessment patients were referred by primary care providers and were evaluated and treated by the GERIATRIC-PACT teamlet, including ordering of tests and medication adjustment, with an average of two visits and active follow-up for one year."
11223855|NCT02356211|FG001|Participant Flow|Control|Geriatric Evaluation and Management Service (GEM) The Geriatric Evaluation and Management Service (GEM) is an acute inpatient service with over 150 discharges annually. Frail elderly treated on GEM receive inter-professional geriatric team assessment and treatment while hospitalized. Patients discharged to home return to the care of their primary physicians.
11224527|NCT02360488|EG000|Reported Event|Telerehabilitation Therapy|"The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.~Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions."
10997682|NCT01040208|OG000|Outcome|Flibanserin 50mg to 100mg Qhs|Group includes the 45 patients who took flibanserin 50 mg q.h.s. for the first 2 weeks followed by flibanserin 100 mg q.h.s.
10997683|NCT01040208|OG001|Outcome|Flibanserin 100mg Qhs|
10997684|NCT01040208|EG000|Reported Event|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
10997685|NCT01040208|EG001|Reported Event|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
10997686|NCT01040208|EG002|Reported Event|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
10997687|NCT01040260|BG000|Baseline|Contingency Management|Use of tangible rewards for verified abstinence
10997688|NCT01040260|BG001|Baseline|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
10997689|NCT01040260|BG002|Baseline|Total|Total of all reporting groups
10997690|NCT01040260|FG000|Participant Flow|Contingency Management|Use of tangible rewards for verified abstinence
10997691|NCT01040260|FG001|Participant Flow|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, carbon monoxide (CO) testing without contingency management
10997692|NCT01040260|OG000|Outcome|Contingency Management|Use of tangible rewards for verified abstinence
10997693|NCT01040260|OG001|Outcome|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
10997694|NCT01040260|EG000|Reported Event|Contingency Management|Use of tangible rewards for verified abstinence
10997695|NCT01040260|EG001|Reported Event|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
10997696|NCT01040351|BG000|Baseline|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
10997697|NCT01040351|BG001|Baseline|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
10997698|NCT01040351|BG002|Baseline|Total|Total of all reporting groups
10997699|NCT01040351|FG000|Participant Flow|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
10997700|NCT01040351|FG001|Participant Flow|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
11336467|NCT03566823|OG002|Outcome|Ontamalimab 75 mg|Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10997701|NCT01040351|OG000|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
10997702|NCT01040351|OG001|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
10997703|NCT01040351|EG000|Reported Event|1: Hydrosalpinx Needle Aspiration|Aspiration of hydrosalpingeal fluid prior to IVF-ET
10997704|NCT01040351|EG001|Reported Event|2. no Aspiration|IVF-ET without any prior intervention
10997705|NCT01040403|BG000|Baseline|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:~Olodaterol 5 µg and placebo~Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution~Olodaterol 10 µg and placebo~Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
10997706|NCT01040403|FG000|Participant Flow|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:~Olodaterol 5 µg and placebo~Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution~Olodaterol 10 µg and placebo~Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
10997707|NCT01040403|OG000|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10997708|NCT01040403|OG001|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997709|NCT01040403|OG002|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997710|NCT01040403|OG003|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997711|NCT01040403|OG004|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10997712|NCT01040403|OG005|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997713|NCT01040403|OG006|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
10997714|NCT01040403|OG007|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997715|NCT01040403|OG006|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997716|NCT01040403|EG000|Reported Event|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10997717|NCT01040403|EG001|Reported Event|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997718|NCT01040403|EG002|Reported Event|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997719|NCT01040403|EG003|Reported Event|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997720|NCT01040403|EG004|Reported Event|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10997721|NCT01040403|EG005|Reported Event|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997722|NCT01040403|EG006|Reported Event|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997723|NCT01040403|EG007|Reported Event|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
10997724|NCT01040689|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 108 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
10997725|NCT01040689|FG000|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
10997726|NCT01040689|FG001|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
10997727|NCT01040689|FG002|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
10997728|NCT01040689|FG003|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
10997729|NCT01040689|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
10997730|NCT01040689|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997731|NCT01040689|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997732|NCT01040689|OG003|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
10997733|NCT01040689|OG003|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
10997734|NCT01040689|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
10997735|NCT01040689|OG001|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997736|NCT01040689|OG002|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997737|NCT01040689|OG003|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
10997738|NCT01040689|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
10997739|NCT01040689|EG001|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997740|NCT01040689|EG002|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997741|NCT01040689|EG003|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
10997742|NCT01040728|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 122 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
10997743|NCT01040728|FG000|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|"Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
10997744|NCT01040728|FG001|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|"Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
10997745|NCT01040728|FG002|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|"Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
10997746|NCT01040728|FG003|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|"Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
10997747|NCT01040728|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
10997748|NCT01040728|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997749|NCT01040728|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997750|NCT01040728|OG003|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
10997751|NCT01040728|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10997752|NCT01040728|OG003|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
10997753|NCT01040728|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
10997754|NCT01040728|OG001|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997755|NCT01040728|OG002|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997756|NCT01040728|OG003|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
10997757|NCT01040728|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10997758|NCT01040728|EG001|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997759|NCT01040728|EG002|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997760|NCT01040728|EG003|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
10997761|NCT01040780|BG000|Baseline|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
10997762|NCT01040780|BG001|Baseline|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
10997763|NCT01040780|BG002|Baseline|Total|Total of all reporting groups
10997764|NCT01040780|FG000|Participant Flow|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
10997765|NCT01040780|FG001|Participant Flow|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
10997766|NCT01040780|OG000|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
10997767|NCT01040780|OG001|Outcome|Gefitinib|250 mg every 24 hours by mouth
10997768|NCT01040780|OG001|Outcome|Gefitinib|250 mg daily by mouth
10997769|NCT01040780|OG000|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
10997770|NCT01040780|OG001|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
10997771|NCT01040780|EG000|Reported Event|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
10997772|NCT01040780|EG001|Reported Event|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
10997773|NCT01040793|BG000|Baseline|Overall Study|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
10997774|NCT01040793|FG000|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
10997775|NCT01040793|FG001|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
10997776|NCT01040793|FG002|Participant Flow|Olo 5mcg/ Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
10997777|NCT01040793|FG003|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
10997778|NCT01040793|FG004|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
10997779|NCT01040793|FG005|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
10997780|NCT01040793|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10997781|NCT01040793|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
10997782|NCT01040793|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
10997783|NCT01040793|OG001|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997784|NCT01040793|OG002|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997785|NCT01040793|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10997786|NCT01040793|EG001|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10997787|NCT01040793|EG002|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10997788|NCT01040819|BG000|Baseline|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
11336468|NCT03566823|EG000|Reported Event|Placebo|Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10997789|NCT01040819|BG001|Baseline|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
10997790|NCT01040819|BG002|Baseline|Total|Total of all reporting groups
10997791|NCT01040819|FG000|Participant Flow|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
10997792|NCT01040819|FG001|Participant Flow|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
10997793|NCT01040819|OG000|Outcome|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
10997794|NCT01040819|OG001|Outcome|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
10997795|NCT01040819|EG000|Reported Event|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
10997796|NCT01040819|EG001|Reported Event|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
10997797|NCT01040832|BG000|Baseline|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
10997798|NCT01040832|BG001|Baseline|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
10997799|NCT01040832|BG002|Baseline|Total|Total of all reporting groups
10997800|NCT01040832|FG000|Participant Flow|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
10997801|NCT01040832|FG001|Participant Flow|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
10997802|NCT01040832|OG000|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
10997803|NCT01040832|OG001|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
10997804|NCT01040832|EG000|Reported Event|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
10997805|NCT01040832|EG001|Reported Event|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
10997806|NCT01040845|BG000|Baseline|Oral Contraceptive With Placebo Then Colchicine|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
10997807|NCT01040845|BG001|Baseline|Oral Contraceptive With Colchicine Then Placebo|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
10997808|NCT01040845|BG002|Baseline|Total|Total of all reporting groups
10997809|NCT01040845|FG000|Participant Flow|Oral Contraceptive With Placebo Then Colchicine|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (matching placebo capsule during the first cycle or over-encapsulated colchicine tablets 0.6 mg during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
10997810|NCT01040845|FG001|Participant Flow|Oral Contraceptive With Colchicine Then Placebo|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (over-encapsulated colchicine tablets 0.6 mg during or matching placebo capsule during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
10997811|NCT01040845|OG000|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
10997812|NCT01040845|OG000|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
10997813|NCT01040845|OG000|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
10997814|NCT01040845|OG000|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
10997815|NCT01040845|OG000|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
10997816|NCT01040845|EG000|Reported Event|Oral Contraceptive With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
10997817|NCT01040858|BG000|Baseline|Cognitive Strategies Group|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
10997818|NCT01040858|BG001|Baseline|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
11223856|NCT02356211|OG000|Outcome|Treatment|"Geriatric Multifactorial Falls Assessment Clinic~Multifactorial Falls Assessment: The Geriatric Multifactorial Falls Assessment Clinic is a component of GERIACTRIC-PACT, a frail-elderly primary care patient-centered medical home with care provided by an inter-professional teamlet consisting of a geriatrician, geriatric nurse practitioner, clinical pharmacist, licensed practical nurse, nurse care manager, social worker, and dietitian. GERIATRIC-PACT operates with increased ancillary support compared to Primary Care PACT. Falls assessment patients were referred by primary care providers and were evaluated and treated by the GERIATRIC-PACT teamlet, including ordering of tests and medication adjustment, with an average of two visits and active follow-up for one year."
11223857|NCT02356211|OG001|Outcome|Control|Geriatric Evaluation and Management Service (GEM)
11223858|NCT02356211|EG000|Reported Event|Treatment|"Geriatric Multifactorial Falls Assessment Clinic~Multifactorial Falls Assessment: The Geriatric Multifactorial Falls Assessment Clinic is a component of GERIACTRIC-PACT, a frail-elderly primary care patient-centered medical home with care provided by an inter-professional teamlet consisting of a geriatrician, geriatric nurse practitioner, clinical pharmacist, licensed practical nurse, nurse care manager, social worker, and dietitian. GERIATRIC-PACT operates with increased ancillary support compared to Primary Care PACT. Falls assessment patients were referred by primary care providers and were evaluated and treated by the GERIATRIC-PACT teamlet, including ordering of tests and medication adjustment, with an average of two visits and active follow-up for one year. -- open label"
11223859|NCT02356211|EG001|Reported Event|Control|"Geriatric Evaluation and Management Service (GEM)~The Geriatric Evaluation and Management Service (GEM) is an acute inpatient service with over 150 discharges annually. Frail elderly treated on GEM receive inter-professional geriatric team assessment and treatment while hospitalized. Patients discharged to home return to the care of their primary physicians.- open label"
11223860|NCT02356471|BG000|Baseline|Supportive Care (Consumer-based Activity Monitor)|"Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.~Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity~Questionnaire Administration: Ancillary studies~Quality-of-Life Assessment: Ancillary studies"
11223861|NCT02356471|FG000|Participant Flow|Supportive Care (Consumer-based Activity Monitor)|"Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.~Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity~Questionnaire Administration: Ancillary studies~Quality-of-Life Assessment: Ancillary studies"
11223862|NCT02356471|OG000|Outcome|Supportive Care (Consumer-based Activity Monitor)|"Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.~Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity~Questionnaire Administration: Ancillary studies~Quality-of-Life Assessment: Ancillary studies"
11223863|NCT02356471|EG000|Reported Event|Supportive Care (Consumer-based Activity Monitor)|"Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.~Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity~Questionnaire Administration: Ancillary studies~Quality-of-Life Assessment: Ancillary studies"
11223864|NCT02356484|BG000|Baseline|Major Abdominal Surgery Cohort|In this surgical cohort, 4 inflammatory markers were measured: albumin, procalcitonin, CRP and lactate levels
10997819|NCT01040858|BG002|Baseline|Total|Total of all reporting groups
10997820|NCT01040858|FG000|Participant Flow|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
10997821|NCT01040858|FG001|Participant Flow|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
10997822|NCT01040858|OG000|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
10997823|NCT01040858|OG001|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
11223865|NCT02356484|FG000|Participant Flow|Major Abdominal Surgery Cohort|"One-arm study including all patients undergoing major abdominal surgery according to the provided definition."
11223866|NCT02356484|OG000|Outcome|Major Abdominal Surgery Cohort|Albumin was measured preoperatively and in postoperative day 1 for all 138 study participants
11223867|NCT02356484|EG000|Reported Event|Major Abdominal Surgery Cohort|Patients undergoing major abdominal surgery according to the provided definition
11223868|NCT02356562|BG000|Baseline|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks
11223869|NCT02356562|BG001|Baseline|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
11223870|NCT02356562|BG002|Baseline|Total|Total of all reporting groups
11223871|NCT02356562|FG000|Participant Flow|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks
11223872|NCT02356562|FG001|Participant Flow|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
11223873|NCT02356562|OG000|Outcome|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks
11223874|NCT02356562|OG000|Outcome|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
11223875|NCT02356562|OG001|Outcome|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
11223876|NCT02356562|EG000|Reported Event|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily [QD] and dasabuvir [250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks.
11223877|NCT02356562|EG001|Reported Event|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg QD and dasabuvir [250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks.
11223878|NCT02356588|BG000|Baseline|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
11223879|NCT02356588|BG001|Baseline|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
11223880|NCT02356588|BG002|Baseline|Total|Total of all reporting groups
11223881|NCT02356588|FG000|Participant Flow|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
11223882|NCT02356588|FG001|Participant Flow|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
11223883|NCT02356588|OG000|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
11223884|NCT02356588|OG001|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
11336469|NCT03566823|EG001|Reported Event|Ontamalimab 25 mg|Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10997824|NCT01040858|OG001|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
10997825|NCT01040858|OG000|Outcome|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
10997826|NCT01040858|OG001|Outcome|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
10997827|NCT01040858|EG000|Reported Event|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
10997828|NCT01040858|EG001|Reported Event|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
10997829|NCT01040871|BG000|Baseline|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
10997830|NCT01040871|BG001|Baseline|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
10997831|NCT01040871|BG002|Baseline|Total|Total of all reporting groups
10997832|NCT01040871|FG000|Participant Flow|VR-CAP|VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
11336470|NCT03566823|EG002|Reported Event|Ontamalimab 75 mg|Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
10997833|NCT01040871|FG001|Participant Flow|R-CHOP|R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
10997834|NCT01040871|OG000|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
10997835|NCT01040871|OG001|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
10997836|NCT01040871|EG000|Reported Event|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
10997837|NCT01040871|EG001|Reported Event|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
10997838|NCT01041209|BG000|Baseline|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
10997839|NCT01041209|BG001|Baseline|Guideline|Enforced guidelines
10997840|NCT01041209|BG002|Baseline|Total|Total of all reporting groups
10997841|NCT01041209|FG000|Participant Flow|Bacterial Pneumonia Score (BPS)|Use of antibiotics according to Bacterial Pneumonia Score (BPS) guidance (antibiotic use when BPS > or = 4 points)
10997842|NCT01041209|FG001|Participant Flow|Guideline|Use of antibiotics according to local enforced guidelines
10997843|NCT01041209|OG000|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
10997844|NCT01041209|OG001|Outcome|Guideline|Indication of antibiotics according to local (Hospital) guidelines
10997845|NCT01041209|OG001|Outcome|Guideline|Indication of antibiotics according to local (Hospital)guidelines.
10997846|NCT01041209|EG000|Reported Event|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
10997847|NCT01041209|EG001|Reported Event|Guideline|Enforced guidelines
10997848|NCT01041248|BG000|Baseline|Tocilizumab|Tocilizumab: 8mg/kg every 2 weeks i.v.
10997849|NCT01041248|FG000|Participant Flow|Tocilizumab|Tocilizumab: 8mg/kg every 2 weeks i.v.
10997850|NCT01041248|OG000|Outcome|Tocilizumab|Tocilizumab: 8mg/kg every 2 weeks i.v.
10997851|NCT01041248|OG000|Outcome|Tocilizumab|treatment arm
10997852|NCT01041248|EG000|Reported Event|Tocilizumab|Tocilizumab: 8mg/kg every 2 weeks i.v.
10997853|NCT01041274|BG000|Baseline|Citalopram|"Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.~Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily."
10997854|NCT01041274|BG001|Baseline|Placebo|"Participants will receive a daily dose of placebo for 12 months.~Placebo: Placebo by mouth daily for 12 months.~Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions~Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI~Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52"
10997855|NCT01041274|BG002|Baseline|Total|Total of all reporting groups
10997856|NCT01041274|FG000|Participant Flow|Citalopram|"Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.~Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily."
11007613|NCT01091974|BG001|Baseline|2 - CBT-I + Armodafinil|"CBT-I + Armodafinil~armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
11007614|NCT01091974|BG002|Baseline|3 - Placebo Only|"Placebo only~Placebo Comparator: Placebo for 47 days"
11007615|NCT01091974|BG003|Baseline|4 - Armodafinil Only|"Armodafinil only~armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)"
11007616|NCT01091974|BG004|Baseline|Total|Total of all reporting groups
11223885|NCT02356588|EG000|Reported Event|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
11223886|NCT02356588|EG001|Reported Event|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
11223887|NCT02356692|BG000|Baseline|Overall Study Group|participants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye.
11223888|NCT02356692|FG000|Participant Flow|Enfilcon A|"participants randomized to wear the (enfilcon A) test lens in one eye.~Enfilcon A: contact lens"
11223889|NCT02356692|FG001|Participant Flow|Senofilcon A|"participants randomized to wear the senofilcon A contact lens (control) in the one eye.~Senofilcon A: contact lens"
11223890|NCT02356692|OG000|Outcome|Enfilcon A|"participants randomized to wear the (enfilcon A) test lens in one eye.~enfilcon A: contact lens"
11223891|NCT02356692|OG001|Outcome|Senofilcon A|"participants randomized to wear the senofilcon A (control) lens in the one eye.~senofilcon A: contact lens"
11223892|NCT02356692|OG001|Outcome|Senofilcon A|"participants randomized to wear the senofilcon A control lens in one eye.~senofilcon A: contact lens"
11223893|NCT02356692|OG000|Outcome|Overall Study Group|"participants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye.~Enfilcon A: contact lens Senofilcon A: contact lens"
11223894|NCT02356692|EG000|Reported Event|Enfilcon A|"participants randomized to wear the test lens (enfilcon A) in one eye.~Enfilcon A: contact lens"
11223895|NCT02356692|EG001|Reported Event|Senofilcon A|"participants randomized to wear the control lens (senofilcon A) in the one eye.~Senofilcon A: contact lens"
11223896|NCT02356783|BG000|Baseline|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
11223897|NCT02356783|BG001|Baseline|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
11223898|NCT02356783|BG002|Baseline|Total|Total of all reporting groups
11223899|NCT02356783|FG000|Participant Flow|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
10877741|NCT00448812|OG002|Outcome|Alair Year 3|"Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3.~Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY"
11223900|NCT02356783|FG001|Participant Flow|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
11223901|NCT02356783|OG000|Outcome|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
11223902|NCT02356783|OG001|Outcome|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
11223903|NCT02356783|EG000|Reported Event|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
11223904|NCT02356783|EG001|Reported Event|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
11223905|NCT02356887|BG000|Baseline|Sitting Position|The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
11223906|NCT02356887|FG000|Participant Flow|Internal Jugular Vein Flow in the Sitting Position|The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
11223907|NCT02356887|OG000|Outcome|Right IJV at Rest|Venous Jugular Flow in the Sitting Position at rest on right Internal Jugular Venous
10877742|NCT00448812|OG003|Outcome|Alair Year 4|"Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4.~Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY"
10877743|NCT00448812|OG004|Outcome|Alair Year 5|"Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5.~Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY"
11223908|NCT02356887|OG001|Outcome|Right IJV With Collar|Venous Jugular Flow in the Sitting Position with collar on right Internal Jugular Venous
10877744|NCT00448812|OG005|Outcome|Control Year 1|Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1.
10877745|NCT00448812|OG006|Outcome|Control Year 2|Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2.
10877746|NCT00448812|OG007|Outcome|Control Year 3|Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3.
10997857|NCT01041274|FG001|Participant Flow|Placebo|"Participants will receive a daily dose of placebo for 12 months.~Placebo: Placebo by mouth daily for 12 months.~Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions~Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI~Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52"
11223909|NCT02356887|OG000|Outcome|Left IJV at Rest|Venous Jugular Flow in the Sitting Position at rest on left Internal Jugular Venous
11223910|NCT02356887|OG001|Outcome|Left IJV With Collar|Venous Jugular Flow in the Sitting Position with collar on left Internal Jugular Venous
11223911|NCT02356887|OG000|Outcome|Right Internal Jugular Vein in the Sitting Position at Rest|The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
11223912|NCT02356887|OG001|Outcome|Right Internal Jugular Vein in the Sitting Position Collar|The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
11223913|NCT02356887|OG001|Outcome|Right Internal Jugular Vein in the Sitting Position Collar|Comparisons of bilateral internal jugular vein cross-sectional area, peak velocity, and ﬂow in the sitting position at rest and with application of the cervical collar
11223914|NCT02356887|EG000|Reported Event|Internal Jugular Venous Flow in Sitting Position|The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
11223915|NCT02356900|BG000|Baseline|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
11223916|NCT02356900|BG001|Baseline|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
11223917|NCT02356900|BG002|Baseline|Total|Total of all reporting groups
11223918|NCT02356900|FG000|Participant Flow|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
10845731|NCT00269152|EG001|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
11007617|NCT01091974|FG000|Participant Flow|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
11223919|NCT02356900|FG001|Participant Flow|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
11223920|NCT02356900|OG000|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
11223921|NCT02356900|OG001|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
11336471|NCT03566979|BG000|Baseline|Placebo|Single dose of two Placebo tablets.
11336472|NCT03566979|BG001|Baseline|Test Naproxen Sodium 440 Milligram (mg)|Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
10997858|NCT01041274|OG000|Outcome|Citalopram|"Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.~Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily."
10997859|NCT01041274|OG001|Outcome|Placebo|"Participants will receive a daily dose of placebo for 12 months.~Placebo: Placebo by mouth daily for 12 months.~Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions~Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI~Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52"
10997860|NCT01041274|EG000|Reported Event|Citalopram|"Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.~Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily."
10997861|NCT01041274|EG001|Reported Event|Placebo|"Participants will receive a daily dose of placebo for 12 months.~Placebo: Placebo by mouth daily for 12 months.~Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions~Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI~Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52"
10997862|NCT01041287|BG000|Baseline|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for 3 months. They crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
10997863|NCT01041287|BG001|Baseline|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for 3 months. They crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
10997864|NCT01041287|BG002|Baseline|Total|Total of all reporting groups
10997865|NCT01041287|FG000|Participant Flow|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
10997866|NCT01041287|FG001|Participant Flow|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
10997867|NCT01041287|OG000|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
11223922|NCT02356900|EG000|Reported Event|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
10997868|NCT01041287|OG001|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
10997869|NCT01041287|EG000|Reported Event|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
11007618|NCT01091974|FG001|Participant Flow|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
10997870|NCT01041287|EG001|Reported Event|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
10997871|NCT01041404|BG000|Baseline|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
10997872|NCT01041404|BG001|Baseline|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
10997873|NCT01041404|BG002|Baseline|Total|Total of all reporting groups
10997874|NCT01041404|FG000|Participant Flow|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-fluorouracil [5-FU] or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.
10997875|NCT01041404|FG001|Participant Flow|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
10997876|NCT01041404|OG000|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
10997877|NCT01041404|OG001|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
10997878|NCT01041404|OG000|Outcome|Fluoropyrimidine, Cisplatin|Participants received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
10997879|NCT01041404|OG001|Outcome|Trastuzumab, Fluoropyrimidine, Cisplatin|Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
10997880|NCT01041404|OG000|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
10997881|NCT01041404|EG000|Reported Event|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
11007619|NCT01091974|FG002|Participant Flow|3- Placebo Only|Placebo Comparator: Placebo for 47 days
11007620|NCT01091974|FG003|Participant Flow|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
11007621|NCT01091974|OG000|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
10845205|NCT00265564|OG000|Outcome|Seeking Safety|"Seeking Safety is a manualized, empirically supported, cognitive behavioral therapy that treats substance use disorders and comorbid PTSD. Participants assigned to the Seeking Safety arm attend two one hour sessions of group therapy for 12 weeks.~Modified Seeking Safety integrated into std outpatient SUD care: The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks."
10845732|NCT00269399|BG000|Baseline|Rifaximin Treatment Arm|"rifaximin 400mg taken 3 times a day~Rifaximin (Xifaxan)"
10997882|NCT01041404|EG001|Reported Event|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
10997883|NCT01041417|BG000|Baseline|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
10997884|NCT01041417|BG001|Baseline|Placebo|Saline injection - three times for four weeks
10997885|NCT01041417|BG002|Baseline|Total|Total of all reporting groups
10997886|NCT01041417|FG000|Participant Flow|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
10997887|NCT01041417|FG001|Participant Flow|Placebo|Saline injection - three times for four weeks
10997888|NCT01041417|OG000|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
10997889|NCT01041417|OG001|Outcome|Placebo|Saline injection - three times for four weeks
10997890|NCT01041417|OG000|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
10997891|NCT01041417|OG001|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
10997892|NCT01041417|EG000|Reported Event|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - Monday, Wednesday and Friday for 4 weeks of therapy.~500 microgram dose of GM-CSF"
10997893|NCT01041417|EG001|Reported Event|Placebo|Saline injection - Monday, Wednesday and Friday for 4 weeks.
10997894|NCT01041495|BG000|Baseline|Cyclobenzaprine ER|
10997895|NCT01041495|BG001|Baseline|Placebo|
10997896|NCT01041495|BG002|Baseline|Total|Total of all reporting groups
10997897|NCT01041495|FG000|Participant Flow|Cyclobenzaprine ER|active muscle relaxant medication
10997898|NCT01041495|FG001|Participant Flow|Placebo|matching placebo
10997899|NCT01041495|OG000|Outcome|Cyclobenzaprine ER|cyclobenzaprine ER (AMRIX): active drug
10997900|NCT01041495|OG001|Outcome|Placebo|placebo: matching placebo for AMRIX
10997901|NCT01041495|EG000|Reported Event|Cyclobenzaprine ER|active drug
10845733|NCT00269399|BG001|Baseline|Vancomycin Comparator Arm|"vancomycin 125mg taken 4 times a day~Vancomycing"
10997902|NCT01041495|EG001|Reported Event|Placebo|inactive placebo matching
10997903|NCT01041521|BG000|Baseline|Lovaza (Omega Three Fatty Acid)|"Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.~Other Names:~Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules~Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months"
10997904|NCT01041521|BG001|Baseline|Sugar Pill|"Dietary Supplement: sugar pill~2 capsules given twice daily Arms: sugar pill"
10997905|NCT01041521|BG002|Baseline|Total|Total of all reporting groups
10845734|NCT00269399|BG002|Baseline|Total|Total of all reporting groups
10997906|NCT01041521|FG000|Participant Flow|Lovaza (Omega Three Fatty Acid)|"Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months~Other Names:~Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules"
10997907|NCT01041521|FG001|Participant Flow|Sugar Pill|"Dietary Supplement: sugar pill~2 capsules given twice daily for 24 months"
10997908|NCT01041521|OG000|Outcome|Lovaza (Omega Three Fatty Acid)|"Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.~Other Names:~Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules~Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months"
10997909|NCT01041521|OG001|Outcome|Sugar Pill|"Dietary Supplement: sugar pill~2 capsules given twice daily Arms: sugar pill"
10997910|NCT01041521|EG000|Reported Event|Lovaza (Omega Three Fatty Acid)|"Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.~Other Names:~Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules~Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months"
10997911|NCT01041521|EG001|Reported Event|Sugar Pill|"Dietary Supplement: sugar pill~2 capsules given twice daily Arms: sugar pill"
10997912|NCT01041573|BG000|Baseline|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
10997913|NCT01041573|BG001|Baseline|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
10997914|NCT01041573|BG002|Baseline|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
10997915|NCT01041573|BG003|Baseline|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day56 and month 7-13
10997916|NCT01041573|BG004|Baseline|Total|Total of all reporting groups
10997917|NCT01041573|FG000|Participant Flow|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
10997918|NCT01041573|FG001|Participant Flow|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
10997919|NCT01041573|FG002|Participant Flow|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
10997920|NCT01041573|FG003|Participant Flow|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
10997921|NCT01041573|OG000|Outcome|IC51, Subjects Aged >= 1 Year|IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
10997922|NCT01041573|OG001|Outcome|Havrix 720|Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged > 1 year
10997923|NCT01041573|OG002|Outcome|IC51, Subjects Aged >= 2 Months to <1 Year|Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
10997924|NCT01041573|OG003|Outcome|Prevnar|"Active comparator in subjects aged ≥ 2 months to < 1 year:~Subjects aged ≥ 2 to < 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to < 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).~Subjects aged ≥ 6 months to < 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7."
10997925|NCT01041573|OG000|Outcome|IC51 0.25 mL|"Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28~IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28"
10997926|NCT01041573|OG001|Outcome|IC51 0.5 mL|"Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28~IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28"
10997927|NCT01041573|OG001|Outcome|Havrix 720|Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged ≥1 to <18 years
10997928|NCT01041573|OG003|Outcome|Prevnar|"Active comparator for subjects < 1 year of age:~Subjects aged ≥ 2 to < 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to < 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).~Subjects aged ≥ 6 months to < 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7."
10997929|NCT01041573|OG001|Outcome|Havrix 720|Havrix®720 0.5 ml im. at day 0 and month 7; Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged ≥1 to <18 years
10997930|NCT01041573|OG000|Outcome|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
10997931|NCT01041573|OG001|Outcome|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
10997932|NCT01041573|OG002|Outcome|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
10997933|NCT01041573|OG003|Outcome|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day56 and month 7-13
10997934|NCT01041573|EG000|Reported Event|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
10997935|NCT01041573|EG001|Reported Event|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
10997936|NCT01041573|EG002|Reported Event|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
10997937|NCT01041573|EG003|Reported Event|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
10997938|NCT01041638|BG000|Baseline|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10997939|NCT01041638|FG000|Participant Flow|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10997940|NCT01041638|OG000|Outcome|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10997941|NCT01041638|EG000|Reported Event|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10997942|NCT01041781|BG000|Baseline|Arm I (Arm A: Celecoxib + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
10997943|NCT01041781|BG001|Baseline|Arm II (Arm B: Placebo + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
10997944|NCT01041781|BG002|Baseline|Total|Total of all reporting groups
10997945|NCT01041781|FG000|Participant Flow|Arm I (Arm A: Celecoxib + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
10997946|NCT01041781|FG001|Participant Flow|Arm II (Arm B: Placebo + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
10997947|NCT01041781|OG000|Outcome|Arm I (Arm A: Celecoxib + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
10997948|NCT01041781|OG001|Outcome|Arm II (Arm B: Placebo + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
10997949|NCT01041781|OG000|Outcome|Arm I (Arm A: Celecoxib + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21.
10997950|NCT01041781|OG001|Outcome|Arm II (Arm B: Placebo + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21.
10997951|NCT01041781|OG000|Outcome|PGE-M < Q1|Patients with urinary PGE-M < Q1 (10.09) at baseline
10997952|NCT01041781|OG001|Outcome|PGE-M >= Q1|Patients with urinary PGE-M >= Q1 (10.09) at baseline
10997953|NCT01041781|OG000|Outcome|PGE-M < Q2|Patients with urinary PGE-M < Q2 (15.38) at baseline
10997954|NCT01041781|OG001|Outcome|PGE-M >= Q2|Patients with urinary PGE-M >= Q2 (15.38) at baseline
10997955|NCT01041781|OG000|Outcome|PGE-M < Q3|Patients with urinary PGE-M < Q3 (27.86) at baseline
10997956|NCT01041781|OG001|Outcome|PGE-M >= Q3|Patients with urinary PGE-M >= Q3 (27.86) at baseline
10997957|NCT01041781|EG000|Reported Event|Arm I (Arm A: Celecoxib + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
10997958|NCT01041781|EG001|Reported Event|Arm II (Arm B: Placebo + Standard Chemotherapy)|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
10997959|NCT01041859|BG000|Baseline|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
10997960|NCT01041859|BG001|Baseline|DB Placebo|Double-Blind Placebo Control Group
10997961|NCT01041859|BG002|Baseline|Total|Total of all reporting groups
10997962|NCT01041859|FG000|Participant Flow|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
10997963|NCT01041859|FG001|Participant Flow|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
10997964|NCT01041859|FG002|Participant Flow|DB Placebo|Double-Blind Placebo Control Group
10997965|NCT01041859|OG000|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
10997966|NCT01041859|OG001|Outcome|DB Placebo|Double-Blind Placebo Control Group
10997967|NCT01041859|EG000|Reported Event|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
10997968|NCT01041859|EG001|Reported Event|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
10997969|NCT01041859|EG002|Reported Event|DB Placebo|Double-Blind Placebo Control Group
10997970|NCT01041976|BG000|Baseline|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
10997971|NCT01041976|BG001|Baseline|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
10997972|NCT01041976|BG002|Baseline|Total|Total of all reporting groups
10997973|NCT01041976|FG000|Participant Flow|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
10997974|NCT01041976|FG001|Participant Flow|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
10997975|NCT01041976|OG000|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
10997976|NCT01041976|OG001|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
10997977|NCT01041976|EG000|Reported Event|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
10997978|NCT01041976|EG001|Reported Event|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
10997979|NCT01042093|BG000|Baseline|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997980|NCT01042093|BG001|Baseline|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
10997981|NCT01042093|BG002|Baseline|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997982|NCT01042093|BG003|Baseline|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
10997983|NCT01042093|BG004|Baseline|Total|Total of all reporting groups
10997984|NCT01042093|FG000|Participant Flow|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997985|NCT01042093|FG001|Participant Flow|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
10997986|NCT01042093|FG002|Participant Flow|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997987|NCT01042093|FG003|Participant Flow|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
10997988|NCT01042093|OG000|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997989|NCT01042093|OG001|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
10997990|NCT01042093|OG002|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997991|NCT01042093|OG003|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
10997992|NCT01042093|OG001|Outcome|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
10997993|NCT01042093|OG002|Outcome|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997994|NCT01042093|OG003|Outcome|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
10997995|NCT01042093|EG000|Reported Event|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997996|NCT01042093|EG001|Reported Event|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
10997997|NCT01042093|EG002|Reported Event|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
10997998|NCT01042093|EG003|Reported Event|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
10997999|NCT01042145|BG000|Baseline|Prednisone|
10998000|NCT01042145|BG001|Baseline|Dexamethasone|
10998001|NCT01042145|BG002|Baseline|Total|Total of all reporting groups
10998002|NCT01042145|FG000|Participant Flow|Prednisone|
10998003|NCT01042145|FG001|Participant Flow|Dexamethasone|
10998004|NCT01042145|OG000|Outcome|Prednisone|
10998005|NCT01042145|OG001|Outcome|Dexamethasone|
10998006|NCT01042145|EG000|Reported Event|Prednisone|
10998007|NCT01042145|EG001|Reported Event|Dexamethasone|
10998008|NCT01042158|BG000|Baseline|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~Tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
10998009|NCT01042158|FG000|Participant Flow|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
10998010|NCT01042158|OG000|Outcome|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
10998011|NCT01042158|EG000|Reported Event|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
10998012|NCT01042236|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first.
10998013|NCT01042236|FG000|Participant Flow|Sequence ABC|Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
10998014|NCT01042236|FG001|Participant Flow|Sequence BCA|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
10998015|NCT01042236|FG002|Participant Flow|Sequence CAB|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
10998016|NCT01042236|FG003|Participant Flow|Sequence ACB|Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
10998017|NCT01042236|FG004|Participant Flow|Sequence BAC|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
10998018|NCT01042236|FG005|Participant Flow|Sequence CBA|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
10998019|NCT01042236|OG000|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
10998020|NCT01042236|OG001|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
10998021|NCT01042236|OG002|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
10998022|NCT01042236|EG000|Reported Event|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
10998023|NCT01042236|EG001|Reported Event|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
10998024|NCT01042236|EG002|Reported Event|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
10998025|NCT01042288|BG000|Baseline|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
10998026|NCT01042288|FG000|Participant Flow|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
11007622|NCT01091974|OG001|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
10998027|NCT01042288|OG000|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
10998028|NCT01042288|EG000|Reported Event|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
10998029|NCT01042366|BG000|Baseline|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998030|NCT01042366|BG001|Baseline|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998031|NCT01042366|BG002|Baseline|DCs Fused With Tumor Cells|"DCs fused with tumor cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998032|NCT01042366|BG003|Baseline|Total|Total of all reporting groups
10998033|NCT01042366|FG000|Participant Flow|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998034|NCT01042366|FG001|Participant Flow|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998035|NCT01042366|FG002|Participant Flow|DCs Fused With Tumor Cells|"DCs fused with tumor cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998036|NCT01042366|OG000|Outcome|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998037|NCT01042366|OG001|Outcome|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998038|NCT01042366|OG002|Outcome|DCs Fused With Tumor Cells|"DCs fused with tumor cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
10998039|NCT01042366|EG000|Reported Event|All Participants (Overall Study)|For all arms: DC vaccine Co-cultured With Melanoma Cells; DC Vaccine Pulsed With Tumor Cell Lysates; DC Vaccines Fused With Tumor Cells
10998040|NCT01042392|BG000|Baseline|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998041|NCT01042392|BG001|Baseline|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998042|NCT01042392|BG002|Baseline|Total|Total of all reporting groups
11007623|NCT01091974|OG002|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
11007624|NCT01091974|OG003|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
10998043|NCT01042392|FG000|Participant Flow|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998044|NCT01042392|FG001|Participant Flow|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
10998045|NCT01042392|FG002|Participant Flow|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998046|NCT01042392|FG003|Participant Flow|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
10998047|NCT01042392|OG000|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998048|NCT01042392|OG001|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998049|NCT01042392|OG000|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998050|NCT01042392|OG001|Outcome|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
10998051|NCT01042392|OG002|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998052|NCT01042392|OG003|Outcome|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
10998053|NCT01042392|EG000|Reported Event|Ramipril (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998054|NCT01042392|EG001|Reported Event|Placebo to Ramipril (Period III)|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
10845206|NCT00265564|OG001|Outcome|Usual Care|"Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.~Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence."
10998055|NCT01042392|EG002|Reported Event|Aliskiren (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
10998056|NCT01042392|EG003|Reported Event|Placebo to Aliskiren (Period III)|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
10998057|NCT01042496|BG000|Baseline|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
11007625|NCT01091974|EG000|Reported Event|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
10998058|NCT01042496|BG001|Baseline|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
10998059|NCT01042496|BG002|Baseline|Total|Total of all reporting groups
10998060|NCT01042496|FG000|Participant Flow|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
10998061|NCT01042496|FG001|Participant Flow|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
10998062|NCT01042496|OG000|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
10998063|NCT01042496|OG001|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
10998064|NCT01042496|OG000|Outcome|Bipolar Lamotrigine Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
10998065|NCT01042496|OG002|Outcome|Bipolar Lamotrigine Non-Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~Non-responders were those bipolar participants who did not achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score <12 at week 12)."
10998066|NCT01042496|OG003|Outcome|Bipolar Lamotrigine Group as Whole|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
10998067|NCT01042496|OG001|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
10998068|NCT01042496|EG000|Reported Event|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
10998069|NCT01042496|EG001|Reported Event|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
10998070|NCT01042509|BG000|Baseline|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
10998071|NCT01042509|FG000|Participant Flow|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
10998072|NCT01042509|OG000|Outcome|Treatment Group|This study had only one arm
10998073|NCT01042509|EG000|Reported Event|Treatment Group|This study had only one arm
10998074|NCT01042535|BG000|Baseline|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
11007626|NCT01091974|EG001|Reported Event|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
11007627|NCT01091974|EG002|Reported Event|3- Placebo Only|Placebo Comparator: Placebo for 47 days
11007628|NCT01091974|EG003|Reported Event|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
10845735|NCT00269399|FG000|Participant Flow|Rifaximin Treatment Arm|"rifaximin 400mg taken 3 times a day~Rifaximin (Xifaxan)"
10998075|NCT01042535|FG000|Participant Flow|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
10998076|NCT01042535|OG000|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
10998077|NCT01042535|EG000|Reported Event|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
10998078|NCT01042600|BG000|Baseline|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
10998079|NCT01042600|BG001|Baseline|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
10998080|NCT01042600|BG002|Baseline|Total|Total of all reporting groups
10998081|NCT01042600|FG000|Participant Flow|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
10998082|NCT01042600|FG001|Participant Flow|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
10998083|NCT01042600|OG000|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
10998084|NCT01042600|OG001|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
10998085|NCT01042600|OG000|Outcome|Endotracheal Intubation|"Endotracheal tube insertion for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
10998086|NCT01042600|EG000|Reported Event|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
10998087|NCT01042600|EG001|Reported Event|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
10998088|NCT01042613|BG000|Baseline|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
10998089|NCT01042613|BG001|Baseline|Standard|(standard technique of insertion of the intravenous cannula)
10998090|NCT01042613|BG002|Baseline|Total|Total of all reporting groups
10998091|NCT01042613|FG000|Participant Flow|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
10998092|NCT01042613|FG001|Participant Flow|Standard|(standard technique of insertion of the intravenous cannula)
10998093|NCT01042613|OG000|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
10998094|NCT01042613|OG001|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
10998095|NCT01042613|EG000|Reported Event|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
10998096|NCT01042613|EG001|Reported Event|Standard|(standard technique of insertion of the intravenous cannula)
10998097|NCT01042678|BG000|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
10998098|NCT01042678|BG001|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
10998099|NCT01042678|BG002|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
10998100|NCT01042678|BG003|Baseline|Total|Total of all reporting groups
10998101|NCT01042678|FG000|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
10998102|NCT01042678|FG001|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
10998103|NCT01042678|FG002|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
10998104|NCT01042678|FG003|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
10998105|NCT01042678|FG004|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
10998106|NCT01042678|FG005|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
10998107|NCT01042678|OG000|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
10998108|NCT01042678|OG001|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
10998109|NCT01042678|OG002|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
10998110|NCT01042678|EG000|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
10998111|NCT01042678|EG001|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
10998112|NCT01042678|EG002|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
10998113|NCT01042795|BG000|Baseline|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
10998114|NCT01042795|FG000|Participant Flow|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
10998115|NCT01042795|OG000|Outcome|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
10998116|NCT01042795|EG000|Reported Event|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
10998117|NCT01042938|BG000|Baseline|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
10998118|NCT01042938|BG001|Baseline|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
10998119|NCT01042938|BG002|Baseline|Total|Total of all reporting groups
10998120|NCT01042938|FG000|Participant Flow|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
10998121|NCT01042938|FG001|Participant Flow|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
10998122|NCT01042938|OG000|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).
10998123|NCT01042938|OG001|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).
10998124|NCT01042938|OG000|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
10998125|NCT01042938|OG001|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
10998126|NCT01042938|EG000|Reported Event|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
10998127|NCT01042938|EG001|Reported Event|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
10998128|NCT01042977|BG000|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus usual care
10845736|NCT00269399|FG001|Participant Flow|Vancomycin Comparator Arm|vancomycin 125mg taken 4 times a day
10998129|NCT01042977|BG001|Baseline|Placebo|Placebo plus usual care
10998130|NCT01042977|BG002|Baseline|Total|Total of all reporting groups
10998131|NCT01042977|FG000|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus usual care
10998132|NCT01042977|FG001|Participant Flow|Placebo|Placebo plus usual care
10998133|NCT01042977|OG000|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
10998134|NCT01042977|OG001|Outcome|Placebo|Placebo plus usual care
10998135|NCT01042977|EG000|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus usual care
10998136|NCT01042977|EG001|Reported Event|Placebo|Placebo plus usual care
10998137|NCT01043094|BG000|Baseline|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
10998138|NCT01043094|BG001|Baseline|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
10998139|NCT01043094|BG002|Baseline|Total|Total of all reporting groups
10998140|NCT01043094|FG000|Participant Flow|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
10998141|NCT01043094|FG001|Participant Flow|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
10998142|NCT01043094|OG000|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
10998143|NCT01043094|OG001|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
10998144|NCT01043094|EG000|Reported Event|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
10998145|NCT01043094|EG001|Reported Event|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
10998146|NCT01043133|BG000|Baseline|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
10998147|NCT01043133|BG001|Baseline|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
10998148|NCT01043133|BG002|Baseline|Total|Total of all reporting groups
10998149|NCT01043133|FG000|Participant Flow|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
10998150|NCT01043133|FG001|Participant Flow|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
10998151|NCT01043133|OG000|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
10998152|NCT01043133|OG001|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
10998153|NCT01043133|EG000|Reported Event|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
10998154|NCT01043133|EG001|Reported Event|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
10998155|NCT01043146|BG000|Baseline|Placebo|intravenous 0.9 % NaCl
10998156|NCT01043146|BG001|Baseline|10 mg COR-1|single intravenous administration
10998157|NCT01043146|BG002|Baseline|40 mg COR-1|single intravenous administration
10998158|NCT01043146|BG003|Baseline|80 mg COR-1|single intravenous administration
10998159|NCT01043146|BG004|Baseline|160 mg COR-1|single intravenous administration
10998160|NCT01043146|BG005|Baseline|240 mg COR-1|single intravenous administration
10998161|NCT01043146|BG006|Baseline|Total|Total of all reporting groups
10998162|NCT01043146|FG000|Participant Flow|Placebo|intravenous 0.9 % NaCl
10998163|NCT01043146|FG001|Participant Flow|10 mg COR-1|single intravenous administration
10998164|NCT01043146|FG002|Participant Flow|40 mg COR-1|single intravenous administration
10998165|NCT01043146|FG003|Participant Flow|80 mg COR-1|single intravenous administration
10998166|NCT01043146|FG004|Participant Flow|160 mg COR-1|single intravenous administration
10998167|NCT01043146|FG005|Participant Flow|240 mg COR-1|single intravenous administration
10998168|NCT01043146|OG000|Outcome|Placebo|intravenous 0.9 % NaCl
10998169|NCT01043146|OG001|Outcome|10 mg COR-1|single intravenous administration
10998170|NCT01043146|OG002|Outcome|40 mg COR-1|single intravenous administration
10998171|NCT01043146|OG003|Outcome|80 mg COR-1|single intravenous administration
10998172|NCT01043146|OG004|Outcome|160 mg COR-1|single intravenous administration
10998173|NCT01043146|OG005|Outcome|240 mg COR-1|single intravenous administration
10998174|NCT01043146|EG000|Reported Event|Placebo|intravenous 0.9 % NaCl
10998175|NCT01043146|EG001|Reported Event|10 mg COR-1|single intravenous administration
10998176|NCT01043146|EG002|Reported Event|40 mg COR-1|single intravenous administration
10998177|NCT01043146|EG003|Reported Event|80 mg COR-1|single intravenous administration
10998178|NCT01043146|EG004|Reported Event|160 mg COR-1|single intravenous administration
10998179|NCT01043146|EG005|Reported Event|240 mg COR-1|single intravenous administration
10998180|NCT01043185|BG000|Baseline|Entire Study Population|Includes all groups randomized to one of 10 sequences of drug or placebo.
10998181|NCT01043185|FG000|Participant Flow|First 30mg, Then 90mg, Then 120mg, Then Placebo|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: AZD3355 120mg. Period 4: placebo. Morning and evening dose in each period.
10998182|NCT01043185|FG001|Participant Flow|First 30mg, Then 90mg, Then Placebo, Then 120mg|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: placebo. Period 4: AZD3355 120mg. Morning and evening dose in each period.
10998183|NCT01043185|FG002|Participant Flow|First 120mg, Then Placebo, Then 240mg, Then 90mg|Period 1: AZD3355 120mg. Period 2: placebo. Period 3: AZD3355 240mg. Period 4: AZD3355 90mg. Morning and evening dose in each period.
10998184|NCT01043185|FG003|Participant Flow|First Placebo, Then 30mg, Then 90mg, Then 120mg|Period 1: placebo. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: AZD3355 120mg. Morning and evening dose in each period.
10998185|NCT01043185|FG004|Participant Flow|First 90mg, Then Placebo, Then 120mg, Then 240mg|Period 1: AZD3355 90mg. Period 2: placebo. Period 3: AZD3355 120mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
10998186|NCT01043185|FG005|Participant Flow|First Placebo, Then 240mg, Then 90mg, Then 30mg|Period 1: placebo. Period 2: AZD3355 240mg. Period 3: AZD3355 90mg. Period 4: AZD3355 30mg. Morning and evening dose in each period.
10998187|NCT01043185|FG006|Participant Flow|First 90mg, Then 120mg, Then Placebo, Then 240mg|Period 1: AZD3355 90mg. Period 2: AZD3355 120mg. Period 3: placebo. Period 4: AZD3355 240mg. Morning and evening dose in each period.
10998188|NCT01043185|FG007|Participant Flow|First 120mg, Then 30mg, Then 240mg, Then Placebo|Period 1: AZD3355 120mg. Period 2: AZD3355 30mg. Period 3: AZD3355 240mg. Period 4: placebo. Morning and evening dose in each period.
10998189|NCT01043185|FG008|Participant Flow|First 240mg, Then 30mg, Then 90mg, Then Placebo|Period 1: AZD3355 240mg. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: placebo. Morning and evening dose in each period.
10998190|NCT01043185|FG009|Participant Flow|First Placebo, Then 120mg, Then 30mg, Then 240mg|Period 1: placebo. Period 2: AZD3355 120mg. Period 3: AZD3355 30mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
10998191|NCT01043185|OG000|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
10998192|NCT01043185|OG001|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
10998193|NCT01043185|OG002|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
10998194|NCT01043185|OG003|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
10998195|NCT01043185|OG004|Outcome|Placebo|a morning and an evening dose of placebo
10998196|NCT01043185|EG000|Reported Event|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
10998197|NCT01043185|EG001|Reported Event|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
10998198|NCT01043185|EG002|Reported Event|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
10998199|NCT01043185|EG003|Reported Event|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
10998200|NCT01043185|EG004|Reported Event|Placebo|a morning and an evening dose of placebo
10998201|NCT01043393|BG000|Baseline|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area.~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
11007629|NCT01092182|BG000|Baseline|Group A - Low-risk Burkitt Lymphoma (BL)|"Burkitt lymphoma Low Risk Arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
10998202|NCT01043393|BG001|Baseline|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area.~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
10998203|NCT01043393|BG002|Baseline|Total|Total of all reporting groups
10998204|NCT01043393|FG000|Participant Flow|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
10998205|NCT01043393|FG001|Participant Flow|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
10998206|NCT01043393|OG000|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
10998207|NCT01043393|OG001|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
10998208|NCT01043393|EG000|Reported Event|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
10998209|NCT01043393|EG001|Reported Event|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
10998210|NCT01043432|BG000|Baseline|Moderate/Severe TBI and History of Suicidal Behavior Group 1|Moderate/severe TBI and history of suicidal behavior
10998211|NCT01043432|BG001|Baseline|Moderate/Severe TBI and no History of Suicidal behaviorGroup 2|Moderate/Severe TBI and no history of suicidal behavior
10998212|NCT01043432|BG002|Baseline|No TBI and a History of Suicidal Behavior Group 3|No TBI and a history of suicidal behavior
10998213|NCT01043432|BG003|Baseline|No TBI and no History of Suicidal Behavior Group 4|No TBI and no history of suicidal behavior
10998214|NCT01043432|BG004|Baseline|Total|Total of all reporting groups
10998215|NCT01043432|FG000|Participant Flow|Group 1|Moderate/severe TBI and history of suicidal behavior = 22
10998216|NCT01043432|FG001|Participant Flow|Group 2|Moderate/Severe TBI and no history of suicidal behavior = 51
10998217|NCT01043432|FG002|Participant Flow|Group 3|No TBI and a history of suicidal behavior = 12
10998218|NCT01043432|FG003|Participant Flow|Group 4|No TBI and no history of suicidal behavior = 48
10998219|NCT01043432|OG000|Outcome|Group 1|Moderate/severe TBI and history of suicidal behavior
10998220|NCT01043432|OG001|Outcome|Group 2|Moderate/Severe TBI and no history of suicidal behavior
10998221|NCT01043432|OG002|Outcome|Group 3|No TBI and a history of suicidal behavior
10998222|NCT01043432|OG003|Outcome|Group 4|No TBI and no history of suicidal behavior
10998223|NCT01043432|EG000|Reported Event|All Groups|
10998224|NCT01043523|BG000|Baseline|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
10998225|NCT01043523|FG000|Participant Flow|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
10998226|NCT01043523|OG000|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
10998227|NCT01043523|OG000|Outcome|Precontrast|45 subjects had a change based on the Precontrast image read
10998228|NCT01043523|OG001|Outcome|Combined Precontrast / Postcontrast|Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
10998229|NCT01043523|OG000|Outcome|Precontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
10998230|NCT01043523|OG001|Outcome|Combined Precontrast / Postcontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
10998231|NCT01043523|EG000|Reported Event|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records.
10998232|NCT01043562|BG000|Baseline|Pediatric ICD Pts|"Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT).~Defibrillator threshold testing: Measurement of the defibrillation threshold was performed using a modified binary search protocol. This protocol specified three distinct inductions of ventricula"
11007630|NCT01092182|BG001|Baseline|Group B - High-Risk Burkitt Lymphoma (BL)|"Burkitt lymphoma High Risk Arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
11336473|NCT03566979|BG002|Baseline|Commercial Naproxen Sodium Tablet 440 mg|Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
10998233|NCT01043562|FG000|Participant Flow|Pediatric ICD Pts|"Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT).~Defibrillator threshold testing: Measurement of the defibrillation threshold was performed using a modified binary search protocol. This protocol specified three distinct inductions of ventricula"
10998234|NCT01043562|OG000|Outcome|Pediatric ICD Pts|Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT).
10998235|NCT01043562|OG000|Outcome|Transvenous ICDs|Patients with an implanted defibrillator system utilizing a transvenous high voltage coil/defibrillator lead.
10998236|NCT01043562|OG001|Outcome|Non-transvenous ICDs|Patients with an implanted defibrillator system utilizing a nontransvenous high voltage coil/defibrillator lead.
10998237|NCT01043562|OG000|Outcome|Post-shock Pacing Assessment|In addition to the baseline study inclusion criteria, this arm included only patients who met the additional inclusion criteria of adequate sinus node function and intact AV node conduction.
10998238|NCT01043562|EG000|Reported Event|Pediatric ICD Pts|Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT).
10998239|NCT01043640|BG000|Baseline|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day -3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
10998240|NCT01043640|FG000|Participant Flow|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day -3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
10998241|NCT01043640|OG000|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day -3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
10998242|NCT01043640|EG000|Reported Event|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day -3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
10998243|NCT01043653|BG000|Baseline|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
10845737|NCT00269399|OG000|Outcome|Rifaximin Treatment Arm|"rifaximin 400mg taken 3 times a day~Rifaximin (Xifaxan)"
10845738|NCT00269399|OG001|Outcome|Vancomycin Comparator Arm|"vancomycin 125mg taken 4 times a day~Vancomycin"
10845739|NCT00269399|EG000|Reported Event|Rifaximin Treatment Arm|"rifaximin 400mg taken 3 times a day~Rifaximin (Xifaxan)"
10845740|NCT00269399|EG001|Reported Event|Vancomycin Comparator Arm|vancomycin 125mg taken 4 times a day
10877747|NCT00448812|EG000|Reported Event|Alair - Year 1|Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
10877748|NCT00448812|EG001|Reported Event|Alair - Year 2|Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
10877749|NCT00448812|EG002|Reported Event|Alair - Year 3|Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
10877750|NCT00448812|EG003|Reported Event|Alair - Year 4|Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
10877751|NCT00448812|EG004|Reported Event|Alair - Year 5|Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
10877752|NCT00448812|EG005|Reported Event|Control - Year 1|Control treated subjects from PREDECESSOR STUDY (NCT00214526).
10877753|NCT00448812|EG006|Reported Event|Control - Year 2|Control treated subjects from PREDECESSOR STUDY (NCT00214526).
10877754|NCT00448812|EG007|Reported Event|Control - Year 3|Control treated subjects from PREDECESSOR STUDY (NCT00214526).
10877755|NCT00448864|BG000|Baseline|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
10877756|NCT00448864|BG001|Baseline|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
10877757|NCT00448864|BG002|Baseline|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
10877758|NCT00448864|BG003|Baseline|Total|Total of all reporting groups
10877759|NCT00448864|FG000|Participant Flow|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
10877760|NCT00448864|FG001|Participant Flow|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
10877761|NCT00448864|FG002|Participant Flow|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
10877762|NCT00448864|OG000|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
10877763|NCT00448864|OG001|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
10877764|NCT00448864|OG002|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
10877765|NCT00448864|OG000|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
10877766|NCT00448864|OG000|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
10877767|NCT00448864|EG000|Reported Event|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
10877768|NCT00448864|EG001|Reported Event|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
10998244|NCT01043653|FG000|Participant Flow|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in mental health outpatient programs
10998245|NCT01043653|OG000|Outcome|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
10998246|NCT01043653|EG000|Reported Event|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in mental health outpatient programs
10998247|NCT01043705|BG000|Baseline|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
10998248|NCT01043705|BG001|Baseline|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
10998249|NCT01043705|BG002|Baseline|CIED Replacement With CRT and TYRX Vs. Case Match Arm|Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients
10998250|NCT01043705|BG003|Baseline|Total|Total of all reporting groups
10998251|NCT01043705|FG000|Participant Flow|ICD With TYRX Implant|All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant
10998252|NCT01043705|FG001|Participant Flow|CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants|Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match
10998253|NCT01043705|FG002|Participant Flow|CRT With no TYRX Retrospective Case Control|Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope
10998254|NCT01043705|OG000|Outcome|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
10998255|NCT01043705|OG001|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
10998256|NCT01043705|OG002|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
10998257|NCT01043705|OG000|Outcome|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
10998258|NCT01043705|EG000|Reported Event|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
10998259|NCT01043705|EG001|Reported Event|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
10998260|NCT01043874|BG000|Baseline|Nilotinib|Nilotinib 400 mg BID
10998261|NCT01043874|FG000|Participant Flow|Nilotinib|Nilotinib 400 mg BID
10998262|NCT01043874|OG000|Outcome|Nilotinib|Nilotinib 400 mg BID
10998263|NCT01043874|EG000|Reported Event|Nilotinib|Nilotinib 400 mg BID
10998264|NCT01043926|BG000|Baseline|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
10998265|NCT01043926|BG001|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
10998266|NCT01043926|BG002|Baseline|Total|Total of all reporting groups
10998267|NCT01043926|FG000|Participant Flow|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
10998268|NCT01043926|FG001|Participant Flow|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
10998269|NCT01043926|FG002|Participant Flow|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
10998270|NCT01043926|FG003|Participant Flow|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
10998271|NCT01043926|OG000|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
10998272|NCT01043926|OG001|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
10998273|NCT01043926|OG000|Outcome|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
10998274|NCT01043926|OG001|Outcome|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
10998275|NCT01043926|EG000|Reported Event|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
10998276|NCT01043926|EG001|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
10998277|NCT01043939|BG000|Baseline|Entire Study Population|Includes groups randomized to receive purple grape juice first and apple juice first
10998278|NCT01043939|FG000|Participant Flow|Arm 1 Purple Grape Juice Then Apple Juice|Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2).
11336474|NCT03566979|BG003|Baseline|Commercial Naproxen Sodium Liquid Gel Capsule 440 mg|Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
10998279|NCT01043939|FG001|Participant Flow|Arm 2 Apple Juice Then Purple Grape Juice|Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2).
10998280|NCT01043939|OG000|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
10998281|NCT01043939|OG001|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
10998282|NCT01043939|OG001|Outcome|Arm 2 Apple Juice Then Purple Grape Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
10998283|NCT01043939|EG000|Reported Event|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
10998284|NCT01043939|EG001|Reported Event|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
10998285|NCT01044030|BG000|Baseline|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
10998286|NCT01044030|BG001|Baseline|Placebo|Placebo: 7.5 mL by mouth three times daily
10998287|NCT01044030|BG002|Baseline|Total|Total of all reporting groups
10998288|NCT01044030|FG000|Participant Flow|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
10998289|NCT01044030|FG001|Participant Flow|Placebo|Placebo: 7.5 mL by mouth three times daily
10998290|NCT01044030|OG000|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
10998291|NCT01044030|OG001|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
10998292|NCT01044030|EG000|Reported Event|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
10998293|NCT01044030|EG001|Reported Event|Placebo|Placebo: 7.5 mL by mouth three times daily
10998294|NCT01044212|BG000|Baseline|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
10998295|NCT01044212|BG001|Baseline|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
10998296|NCT01044212|BG002|Baseline|Total|Total of all reporting groups
10998297|NCT01044212|FG000|Participant Flow|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
10998298|NCT01044212|FG001|Participant Flow|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
10998299|NCT01044212|OG000|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
10998300|NCT01044212|OG001|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
10998301|NCT01044212|EG000|Reported Event|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
10998302|NCT01044212|EG001|Reported Event|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
10998303|NCT01044264|BG000|Baseline|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
10998304|NCT01044264|BG001|Baseline|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
10998305|NCT01044264|BG002|Baseline|Placebo|Placebo : Placebo
10998306|NCT01044264|BG003|Baseline|Total|Total of all reporting groups
10998307|NCT01044264|FG000|Participant Flow|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
10998308|NCT01044264|FG001|Participant Flow|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
10998309|NCT01044264|FG002|Participant Flow|Placebo|Placebo : Placebo
10998310|NCT01044264|OG000|Outcome|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
10998311|NCT01044264|OG001|Outcome|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
10998312|NCT01044264|OG002|Outcome|Placebo|Placebo : Placebo
10998313|NCT01044264|EG000|Reported Event|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
10998314|NCT01044264|EG001|Reported Event|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
10998315|NCT01044264|EG002|Reported Event|Placebo|Placebo : Placebo
10998316|NCT01044290|BG000|Baseline|Arm 1 -Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on issues of heritage and legacy.~Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
10998317|NCT01044290|BG001|Baseline|Arm 2 Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD"
10998318|NCT01044290|BG002|Baseline|Arm 3 Treatment as Usual|"Subjects in the third group (Treatment as Usual) were exposed to no intervention or attention control during the intervention window."
10998319|NCT01044290|BG003|Baseline|Total|Total of all reporting groups
10998320|NCT01044290|FG000|Participant Flow|Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy."
11336475|NCT03566979|BG004|Baseline|Total|Total of all reporting groups
11223923|NCT02356900|EG001|Reported Event|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
11223924|NCT02357043|BG000|Baseline|Dario Blood Glucose Monitoring System|"Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).~Dario Blood Glucose Monitoring System: Finger-stick obtained with BGMS~YSI: Finger-stick sample obtained by nurse/technician to be tested with YSI"
11223925|NCT02357043|FG000|Participant Flow|Dario Blood Glucose Monitoring System|"Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).~Dario Blood Glucose Monitoring System: Finger-stick obtained with BGMS~YSI: Finger-stick sample obtained by nurse/technician to be tested with YSI"
11223926|NCT02357043|OG000|Outcome|Dario Blood Glucose Monitoring System|"Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).~Dario Blood Glucose Monitoring System: Finger-stick obtained with BGMS~YSI: Finger-stick sample obtained by nurse/technician to be tested with YSI"
11223927|NCT02357043|EG000|Reported Event|Dario Blood Glucose Monitoring System|"Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).~Dario Blood Glucose Monitoring System: Finger-stick obtained with BGMS~YSI: Finger-stick sample obtained by nurse/technician to be tested with YSI"
11224474|NCT02360293|EG000|Reported Event|Stay Strong w/Coaching|"Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.~Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program."
11336476|NCT03566979|FG000|Participant Flow|Placebo|Single dose of two Placebo tablets.
11336477|NCT03566979|FG001|Participant Flow|Test Naproxen Sodium 440 Milligram (mg)|Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
10877769|NCT00448864|EG002|Reported Event|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
10877770|NCT00448916|BG000|Baseline|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
10877771|NCT00448916|BG001|Baseline|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
10877772|NCT00448916|BG002|Baseline|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
10877773|NCT00448916|BG003|Baseline|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
10877774|NCT00448916|BG004|Baseline|Total|Total of all reporting groups
10877775|NCT00448916|FG000|Participant Flow|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
10877776|NCT00448916|FG001|Participant Flow|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
10877777|NCT00448916|FG002|Participant Flow|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
10877778|NCT00448916|FG003|Participant Flow|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
10877779|NCT00448916|OG000|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
10877780|NCT00448916|OG001|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
10877781|NCT00448916|OG002|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
10877782|NCT00448916|OG003|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
10877783|NCT00448916|OG003|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
10877784|NCT00448916|EG000|Reported Event|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
10877785|NCT00448916|EG001|Reported Event|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
10998321|NCT01044290|FG001|Participant Flow|Attention Control|"Subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD"
10998322|NCT01044290|FG002|Participant Flow|Arm 3 Treatment as Usual|"Subjects in the third group (treatment as usual) were exposed to no intervention or attention control during the intervention window."
10998323|NCT01044290|OG000|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
10998324|NCT01044290|OG001|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control
10998325|NCT01044290|OG002|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual
10998326|NCT01044290|OG000|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
10998327|NCT01044290|OG001|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control condition.
10998328|NCT01044290|OG002|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
10998329|NCT01044290|OG001|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition.
10998330|NCT01044290|OG002|Outcome|Arm 3 Usual Care|Participants did not receive any intervention but rather care as usual.
10998331|NCT01044290|OG001|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition
10998332|NCT01044290|OG002|Outcome|Arm 3 Treatment as Usual|Participants did not receive any intervention but rather care as usual.
10998333|NCT01044290|OG001|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control.
10998334|NCT01044290|OG002|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual.
10998335|NCT01044290|OG001|Outcome|Arm 2 Attention Control|Participants received relaxation meditation as the attention control condition
10998336|NCT01044290|EG000|Reported Event|Outlook Intervention|"Subjects in the first group (Life Completion) will complete a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
10998337|NCT01044290|EG001|Reported Event|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD."
10998338|NCT01044290|EG002|Reported Event|Treatment as Usual|"Subjects in the third group (treatment as usual) will be exposed to no intervention or attention control during the intervention window."
10998339|NCT01044303|BG000|Baseline|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.~Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
10998340|NCT01044303|FG000|Participant Flow|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.~Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
10998341|NCT01044303|OG000|Outcome|Mycophenolic Acid (MPA) Escalation|Patients receiving MPA (500mg to 2500mg of CellCept daily or 360mg to 1800mg myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months
10998342|NCT01044303|OG000|Outcome|Rate of Infection|Number of patients who had an infection during the course of the study.
10998343|NCT01044303|OG001|Outcome|Rate of Rejection|Number of patients who had a rejection during the course of the study.
10998344|NCT01044303|OG002|Outcome|Renal Function|Number of patients who had stable renal function throughout the study.
10998345|NCT01044303|EG000|Reported Event|Adverse Events|Adverse events reported by participants during the course of the study.
10998346|NCT01044433|BG000|Baseline|Lapatinib Ditosylate and Capecitabine|"Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14.~lapatinib ditosylate: Given orally~capecitabine: Given orally"
10998347|NCT01044433|FG000|Participant Flow|Lapatinib Ditosylate and Capecitabine|"Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14.~lapatinib ditosylate: Given orally~capecitabine: Given orally"
10998348|NCT01044433|OG000|Outcome|Lapatinib Ditosylate and Capecitabine|"Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14.~lapatinib ditosylate: Given orally~capecitabine: Given orally"
10998349|NCT01044433|OG000|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14.~lapatinib ditosylate: Given orally~capecitabine: Given orally"
10998350|NCT01044433|EG000|Reported Event|Lapatinib Ditosylate and Capecitabine|"Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14.~lapatinib ditosylate: Given orally~capecitabine: Given orally"
11007631|NCT01092182|BG002|Baseline|Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)|"Diffuse large B-cell lymphoma (DLBCL) high risk arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
11007632|NCT01092182|BG003|Baseline|Total|Total of all reporting groups
11007633|NCT01092182|FG000|Participant Flow|Low-risk Burkitt Lymphoma (BL)|"Burkitt lymphoma Low Risk Arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
11007634|NCT01092182|FG001|Participant Flow|High-Risk Burkitt Lymphoma (BL)|"Burkitt lymphoma High Risk Arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
11007635|NCT01092182|FG002|Participant Flow|High-Risk Diffuse Large B Cell Lymphoma (DLBCL)|"High-Risk Diffuse Large B Cell Lymphoma~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
10998351|NCT01044459|BG000|Baseline|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10998352|NCT01044459|BG001|Baseline|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10998353|NCT01044459|BG002|Baseline|Total|Total of all reporting groups
10998354|NCT01044459|FG000|Participant Flow|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10998355|NCT01044459|FG001|Participant Flow|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10998356|NCT01044459|OG000|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10998357|NCT01044459|OG001|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10998358|NCT01044459|EG000|Reported Event|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10998359|NCT01044459|EG001|Reported Event|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
10998360|NCT01044498|BG000|Baseline|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
10998361|NCT01044498|BG001|Baseline|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
10998362|NCT01044498|BG002|Baseline|Total|Total of all reporting groups
10998363|NCT01044498|FG000|Participant Flow|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
10998364|NCT01044498|FG001|Participant Flow|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
10998365|NCT01044498|OG000|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
10998366|NCT01044498|OG001|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
10998367|NCT01044498|EG000|Reported Event|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
10998368|NCT01044498|EG001|Reported Event|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
10998369|NCT01044537|BG000|Baseline|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
10998370|NCT01044537|BG001|Baseline|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
10998371|NCT01044537|BG002|Baseline|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
10998372|NCT01044537|BG003|Baseline|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
10998373|NCT01044537|BG004|Baseline|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
10998374|NCT01044537|BG005|Baseline|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
10998375|NCT01044537|BG006|Baseline|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
10998376|NCT01044537|BG007|Baseline|Total|Total of all reporting groups
10998377|NCT01044537|FG000|Participant Flow|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
10998378|NCT01044537|FG001|Participant Flow|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
10998379|NCT01044537|FG002|Participant Flow|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
10998380|NCT01044537|FG003|Participant Flow|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
10998381|NCT01044537|FG004|Participant Flow|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
10998382|NCT01044537|FG005|Participant Flow|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
10998383|NCT01044537|FG006|Participant Flow|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
10998384|NCT01044537|OG000|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
10998385|NCT01044537|OG001|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
10998386|NCT01044537|OG002|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
10998387|NCT01044537|OG003|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
10998388|NCT01044537|OG004|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
10998389|NCT01044537|OG005|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
10998390|NCT01044537|OG006|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
10998391|NCT01044537|EG000|Reported Event|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
10998392|NCT01044537|EG001|Reported Event|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
10998393|NCT01044537|EG002|Reported Event|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
10998394|NCT01044537|EG003|Reported Event|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
10998395|NCT01044537|EG004|Reported Event|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
10998396|NCT01044537|EG005|Reported Event|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
10998397|NCT01044537|EG006|Reported Event|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
10998398|NCT01044576|BG000|Baseline|Multiple Sclerosis|Patients with relapsing-remitting or secondary progressive multiple sclerosis
10998399|NCT01044576|FG000|Participant Flow|Multiple Sclerosis|Patients with relapsing-remitting or secondary progressive multiple sclerosis
10998400|NCT01044576|OG000|Outcome|Multiple Sclerosis|Patients with relapsing-remitting or secondary progressive multiple sclerosis
10998401|NCT01044576|EG000|Reported Event|Multiple Sclerosis|Patients with relapsing-remitting or secondary progressive multiple sclerosis
10998402|NCT01044589|BG000|Baseline|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
10998403|NCT01044589|BG001|Baseline|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
10998404|NCT01044589|BG002|Baseline|Total|Total of all reporting groups
10998405|NCT01044589|FG000|Participant Flow|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
10998406|NCT01044589|FG001|Participant Flow|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
10998407|NCT01044589|OG000|Outcome|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
10998408|NCT01044589|OG001|Outcome|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
10998409|NCT01044589|EG000|Reported Event|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
10998410|NCT01044589|EG001|Reported Event|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
10998411|NCT01044693|BG000|Baseline|All Study Participants|Participants who were randomized to receive placebo, metoprolol, sildenafil and nebivolol in any order
10998412|NCT01044693|FG000|Participant Flow|Placebo Then Metoprolol Then Sildenafil Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998413|NCT01044693|FG001|Participant Flow|Placebo Then Nebivolol Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998414|NCT01044693|FG002|Participant Flow|Placebo Then Sildenafil Then Nebivolol Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998415|NCT01044693|FG003|Participant Flow|Placebo Then Sildenafil Then Metoprolol Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998416|NCT01044693|FG004|Participant Flow|Nebivolol Then Placebo Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998417|NCT01044693|FG005|Participant Flow|Metoprolol Then Sildenafil Then Placebo Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998418|NCT01044693|FG006|Participant Flow|Sildenafil Then Nebivolol Then Placebo Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998419|NCT01044693|FG007|Participant Flow|Metoprolol Then Placebo Then Nebivolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998420|NCT01044693|FG008|Participant Flow|Nebivolol Then Metoprolol Then Sildenafil Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998421|NCT01044693|FG009|Participant Flow|Metoprolol Then Nebivolol Then Placebo Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998422|NCT01044693|FG010|Participant Flow|Metoprolol Then Sildenafil Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998423|NCT01044693|FG011|Participant Flow|Sildenafil Then Nebivolol Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998424|NCT01044693|FG012|Participant Flow|Sildenafil Then Metoprolol Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998425|NCT01044693|FG013|Participant Flow|Nebivolol Then Sildenafil Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998426|NCT01044693|FG014|Participant Flow|Nebivolol Then Placebo Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
11223928|NCT02357134|BG000|Baseline|High Flow Oxygen|High Flow Oxygen were delivered between 20 and 70 L/min
11223929|NCT02357134|BG001|Baseline|High Flow Air|High Flow Air were delivered between 20 and 70 L/min
10998427|NCT01044693|FG015|Participant Flow|Placebo Then Nebivolol Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
10998428|NCT01044693|OG000|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
10998429|NCT01044693|OG001|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
10998430|NCT01044693|OG002|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
10998431|NCT01044693|OG003|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
10998432|NCT01044693|EG000|Reported Event|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
11223930|NCT02357134|BG002|Baseline|Low Flow Oxygen|Low Flow Oxygen were delivered at 2 L/min
11223931|NCT02357134|BG003|Baseline|Low Flow Air|Low Flow Air were delivered at 2 L/min
10998433|NCT01044693|EG001|Reported Event|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
10998434|NCT01044693|EG002|Reported Event|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
10998435|NCT01044693|EG003|Reported Event|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
10998436|NCT01044706|BG000|Baseline|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
10998437|NCT01044706|BG001|Baseline|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
10998438|NCT01044706|BG002|Baseline|Total|Total of all reporting groups
10998439|NCT01044706|FG000|Participant Flow|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
10998440|NCT01044706|FG001|Participant Flow|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
10998441|NCT01044706|OG000|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
10998442|NCT01044706|OG001|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
10998443|NCT01044706|EG000|Reported Event|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
10998444|NCT01044706|EG001|Reported Event|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
10998445|NCT01044732|BG000|Baseline|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
10998446|NCT01044732|BG001|Baseline|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
10998447|NCT01044732|BG002|Baseline|Total|Total of all reporting groups
10998448|NCT01044732|FG000|Participant Flow|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
10998449|NCT01044732|FG001|Participant Flow|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
10998450|NCT01044732|OG000|Outcome|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
10998451|NCT01044732|OG001|Outcome|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
10998452|NCT01044732|OG000|Outcome|All SC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during standard colonoscopies (SC)
10998453|NCT01044732|OG001|Outcome|All TEC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during Third Eye colonoscopies (TEC)
10998454|NCT01044732|EG000|Reported Event|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
10998455|NCT01044732|EG001|Reported Event|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
10998456|NCT01044745|BG000|Baseline|Treatment (Rituximab and Allogeneic HCT Transplant)|"CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.~TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.~laboratory biomarker analysis: Correlative studies~graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy~cyclophosphamide: Given PO or IV~fludarabine phosphate: Given IV~busulfan: Given IV~total-body irradiation: Undergo TBI~graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy~immunosuppressive therapy: Undergo immunosuppressive therapy"
10998457|NCT01044745|FG000|Participant Flow|Treatment (Rituximab and Allogeneic HCT Transplant)|"CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.~TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.~laboratory biomarker analysis: Correlative studies~graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy~cyclophosphamide: Given PO or IV~fludarabine phosphate: Given IV~busulfan: Given IV~total-body irradiation: Undergo TBI~graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy~immunosuppressive therapy: Undergo immunosuppressive therapy"
10998458|NCT01044745|OG000|Outcome|Treatment (Rituximab and Allogeneic HCT Transplant)|"CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.~TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.~laboratory biomarker analysis: Correlative studies~graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy~cyclophosphamide: Given PO or IV~fludarabine phosphate: Given IV~busulfan: Given IV~total-body irradiation: Undergo TBI~graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy~immunosuppressive therapy: Undergo immunosuppressive therapy"
10998459|NCT01044745|OG000|Outcome|Treatment (Rituximab and Allogeneic HCT Transplant)|"CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.~rituximab: Given IV~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV~anti-thymocyte globulin: Given IV~allogeneic hematopoietic stem cell transplantation~laboratory biomarker analysis: Correlative studies~graft versus host disease prophyla"
10998460|NCT01044745|EG000|Reported Event|Treatment (Rituximab and Allogeneic HCT Transplant)|"CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.~TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.~laboratory biomarker analysis: Correlative studies~graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy~cyclophosphamide: Given PO or IV~fludarabine phosphate: Given IV~busulfan: Given IV~total-body irradiation: Undergo TBI~graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy~immunosuppressive therapy: Undergo immunosuppressive therapy"
10998461|NCT01044758|BG000|Baseline|aMCI_62.5mg Drug First, Then Placebo|"Amnestic MCI:~62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
10998462|NCT01044758|BG001|Baseline|aMCI_Placebo First, Then 62.5mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)"
10998463|NCT01044758|BG002|Baseline|aMCI_125mg Drug First, Then Placebo|"Amnestic MCI:~125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
10998464|NCT01044758|BG003|Baseline|aMCI_Placebo First, Then 125mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)"
10998465|NCT01044758|BG004|Baseline|aMCI_250mg Drug First, Then Placebo|"Amnestic MCI:~250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
10998466|NCT01044758|BG005|Baseline|aMCI_Placebo First, Then 250mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)"
10998467|NCT01044758|BG006|Baseline|Control_Placebo First, Then Placebo|"Healthy control~placebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
10998468|NCT01044758|BG007|Baseline|Total|Total of all reporting groups
10998469|NCT01044758|FG000|Participant Flow|aMCI_62.5mg Drug First, Then Placebo|"Amnestic MCI:~62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
10998470|NCT01044758|FG001|Participant Flow|aMCI_Placebo First, Then 62.5mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)"
10998471|NCT01044758|FG002|Participant Flow|aMCI_125mg Drug First, Then Placebo|"Amnestic MCI:~125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
10998472|NCT01044758|FG003|Participant Flow|aMCI_Placebo First, Then 125mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)"
10998473|NCT01044758|FG004|Participant Flow|aMCI_250mg Drug First, Then Placebo|"Amnestic MCI:~250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
10998474|NCT01044758|FG005|Participant Flow|aMCI_Placebo First, Then 250mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)"
10998475|NCT01044758|FG006|Participant Flow|Control_Placebo First, Then Placebo|"Healthy control:~placebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
10998476|NCT01044758|OG000|Outcome|aMCI_62.5|62.5 mg levetiracetam twice daily for two weeks
10998477|NCT01044758|OG001|Outcome|aMCI_62.5 Placebo|62.5mg levetiracetam placebo comparator
10998478|NCT01044758|OG002|Outcome|aMCI_125|125 mg Levetiracetam twice daily for two weeks.
10998479|NCT01044758|OG003|Outcome|aMCI_125 Placebo|125mg levetiracetam placebo comparator
10998480|NCT01044758|OG004|Outcome|aMCI_250|250mg levetiracetam twice daily for two weeks
10998481|NCT01044758|OG005|Outcome|aMCI_250 Placebo|250mg levetiracetam placebo comparator
10998482|NCT01044758|OG006|Outcome|Age Matched Control|Placebo capsule twice daily for two weeks
10998483|NCT01044758|OG000|Outcome|aMCI_62.5|62.5mg levetiracetam twice daily for two weeks
10998484|NCT01044758|OG001|Outcome|aMCI_62.5 Placebo|62.6mg levetiracetam placebo comparator
10998485|NCT01044758|OG002|Outcome|aMCI_125|125mg levetiracetam twice daily for two weeks
10998486|NCT01044758|EG000|Reported Event|aMCI_62.5|62.5 mg levetiracetam twice daily for two weeks
10998487|NCT01044758|EG001|Reported Event|aMCI_62.5 Placebo|62.5 mg placebo comparator (placebo capsule twice daily for two weeks)
10998488|NCT01044758|EG002|Reported Event|aMCI_125|125 mg levetiracetam twice daily for two weeks
10998489|NCT01044758|EG003|Reported Event|aMCI_125 Placebo|125 mg placebo comparator (placebo capsule twice daily for two weeks)
10998490|NCT01044758|EG004|Reported Event|aMCI_250|250 mg levetiracetam twice daily for two weeks
10998491|NCT01044758|EG005|Reported Event|aMCI_250 Placebo|250 mg placebo comparator (placebo capsule twice daily for two weeks)
10998492|NCT01044758|EG006|Reported Event|Age Matched Control|placebo capsule twice daily for two weeks
10998493|NCT01044771|BG000|Baseline|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
10998494|NCT01044771|FG000|Participant Flow|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Tenovovir 300mg was replaced with Raltegravir 400mg twice a day"
10998495|NCT01044771|OG000|Outcome|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients~change from tenofovir to raltegravir: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID"
10998496|NCT01044771|OG000|Outcome|Viral Rebound|Every participant in the study switched to the investigational strategy
11223932|NCT02357134|BG004|Baseline|Total|Total of all reporting groups
11223933|NCT02357134|FG000|Participant Flow|High Flow Oxygen|High Flow Oxygen were delivered between 20 and 70 L/min.
11223934|NCT02357134|FG001|Participant Flow|High Flow Air|High Flow Air were delivered between 20 and 70 L/min.
11223935|NCT02357134|FG002|Participant Flow|Low Flow Oxygen|Low Flow Oxygen were delivered at 2 L/min.
11223936|NCT02357134|FG003|Participant Flow|Low Flow Air|Low Flow Air were delivered at 2 L/min
11223937|NCT02357134|OG000|Outcome|High Flow Oxygen|High Flow Oxygen were delivered between 20 and 70 L/min
11223938|NCT02357134|OG001|Outcome|High Flow Air|High Flow Air were delivered between 20 and 70 L/min
11223939|NCT02357134|OG002|Outcome|Low Flow Oxygen|Low Flow Oxygen were delivered at 2 L/min
10998497|NCT01044771|EG000|Reported Event|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
11223940|NCT02357134|OG003|Outcome|Low Flow Air|Low Flow Air were delivered at 2 L/min
11223941|NCT02357134|EG000|Reported Event|High Flow Oxygen|High Flow Oxygen were delivered between 20 and 70 L/min
11223942|NCT02357134|EG001|Reported Event|High Flow Air|High Flow Air were delivered between 20 and 70 L/min
11223943|NCT02357134|EG002|Reported Event|Low Flow Oxygen|Low Flow Oxygen were delivered at 2 L/min
11223944|NCT02357134|EG003|Reported Event|Low Flow Air|Low Flow Air were delivered at 2 L/min
11223945|NCT02357147|BG000|Baseline|Amatuximab + Pemetrexed + Cisplatin|During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
11223946|NCT02357147|BG001|Baseline|Placebo + Pemetrexed + Cisplatin|During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
10998498|NCT01044862|BG000|Baseline|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
10998499|NCT01044862|BG001|Baseline|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
11223947|NCT02357147|BG002|Baseline|Total|Total of all reporting groups
11223948|NCT02357147|FG000|Participant Flow|Amatuximab + Pemetrexed + Cisplatin|During Combination Treatment Phase, participants received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m^2) and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
11223949|NCT02357147|FG001|Participant Flow|Placebo + Pemetrexed + Cisplatin|During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
11223950|NCT02357147|OG000|Outcome|Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin|During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
11223951|NCT02357147|OG001|Outcome|Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin|During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
11223952|NCT02357147|OG002|Outcome|Maintenance Treatment Phase: Amatuximab|Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
11223953|NCT02357147|OG003|Outcome|Maintenance Treatment Phase: Placebo|Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
11223954|NCT02357147|EG000|Reported Event|Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin|During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
11223955|NCT02357147|EG001|Reported Event|Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin|During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
10998500|NCT01044862|BG002|Baseline|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
10998501|NCT01044862|BG003|Baseline|Total|Total of all reporting groups
10998502|NCT01044862|FG000|Participant Flow|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
10998503|NCT01044862|FG001|Participant Flow|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
10998504|NCT01044862|FG002|Participant Flow|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
10998505|NCT01044862|OG000|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
10998506|NCT01044862|OG001|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
10998507|NCT01044862|OG002|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
10998508|NCT01044862|EG000|Reported Event|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
10998509|NCT01044862|EG001|Reported Event|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
10998510|NCT01044862|EG002|Reported Event|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
10998511|NCT01044966|BG000|Baseline|ITV DepoCyt + Temozolomide|"Patients will undergo an induction phase of intraventricular (ITV) DepoCyt, using the dosage determined from the Phase I portionPatients with stable disease (clinically and radiographically), not exhibiting systemic toxicity, will undergo a three month consolidation phase of ITV DepoCyt, for one month (Cycles 3-6). Patients without progression or toxicity will undergo maintenance therapy using ITV DepoCyt every four weeks (+/- 3 days) for a maximum of 8 months (cycles 7-14) or until recurrence or toxicity ensues.~ITV DepoCyt + Temozolomide: Intrathecal liposomal Ara-C dosing will begin at 50 mg ITV every 2-4 weeks, and de-escalated based on toxicity obtained from the Phase I portion of the trial. Metronomic dosing of temozolomide will be given at 75 mg/m2 for 21 days (continuous ora"
11007636|NCT01092182|OG000|Outcome|Group A - Low-risk Burkitt Lymphoma (BL)|"Burkitt lymphoma Low Risk Arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
11007637|NCT01092182|OG001|Outcome|Group B - High-Risk Burkitt Lymphoma (BL)|"Burkitt lymphoma High Risk Arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
11007638|NCT01092182|OG002|Outcome|Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)|"Diffuse large B-cell lymphoma (DLBCL) high risk arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
10998512|NCT01044966|FG000|Participant Flow|ITV DepoCyt + Temozolomide|"Patients will undergo an induction phase of intraventricular (ITV) DepoCyt, using the dosage determined from the Phase I portionPatients with stable disease (clinically and radiographically), not exhibiting systemic toxicity, will undergo a three month consolidation phase of ITV DepoCyt, for one month (Cycles 3-6). Patients without progression or toxicity will undergo maintenance therapy using ITV DepoCyt every four weeks (+/- 3 days) for a maximum of 8 months (cycles 7-14) or until recurrence or toxicity ensues.~ITV DepoCyt + Temozolomide: Intrathecal liposomal Ara-C dosing will begin at 50 mg ITV every 2-4 weeks, and de-escalated based on toxicity obtained from the Phase I portion of the trial. Metronomic dosing of temozolomide will be given at 75 mg/m2 for 21 days (continuous ora"
10998513|NCT01044966|OG000|Outcome|ITV DepoCyt + Temozolomide|"Patients will undergo an induction phase of intraventricular (ITV) DepoCyt, using the dosage determined from the Phase I portionPatients with stable disease (clinically and radiographically), not exhibiting systemic toxicity, will undergo a three month consolidation phase of ITV DepoCyt, for one month (Cycles 3-6). Patients without progression or toxicity will undergo maintenance therapy using ITV DepoCyt every four weeks (+/- 3 days) for a maximum of 8 months (cycles 7-14) or until recurrence or toxicity ensues.~ITV DepoCyt + Temozolomide: Intrathecal liposomal Ara-C dosing will begin at 50 mg ITV every 2-4 weeks, and de-escalated based on toxicity obtained from the Phase I portion of the trial. Metronomic dosing of temozolomide will be given at 75 mg/m2 for 21 days (continuous oral dosing), followed by 7 days off in a 28 day cycle as a once daily dosing regimen."
10998514|NCT01044966|OG000|Outcome|ITV DepoCyt + Temozolomide|"Patients will undergo an induction phase of intraventricular (ITV) DepoCyt, using the dosage determined from the Phase I portionPatients with stable disease (clinically and radiographically), not exhibiting systemic toxicity, will undergo a three month consolidation phase of ITV DepoCyt, for one month (Cycles 3-6). Patients without progression or toxicity will undergo maintenance therapy using ITV DepoCyt every four weeks (+/- 3 days) for a maximum of 8 months (cycles 7-14) or until recurrence or toxicity ensues.~ITV DepoCyt + Temozolomide: Intrathecal liposomal Ara-C dosing will begin at 50 mg ITV every 2-4 weeks, and de-escalated based on toxicity obtained from the Phase I portion of the trial. Metronomic dosing of temozolomide will be given at 75 mg/m2 for 21 days (continuous ora"
10998515|NCT01044966|EG000|Reported Event|ITV DepoCyt + Temozolomide|"Patients will undergo an induction phase of intraventricular (ITV) DepoCyt, using the dosage determined from the Phase I portionPatients with stable disease (clinically and radiographically), not exhibiting systemic toxicity, will undergo a three month consolidation phase of ITV DepoCyt, for one month (Cycles 3-6). Patients without progression or toxicity will undergo maintenance therapy using ITV DepoCyt every four weeks (+/- 3 days) for a maximum of 8 months (cycles 7-14) or until recurrence or toxicity ensues.~ITV DepoCyt + Temozolomide: Intrathecal liposomal Ara-C dosing will begin at 50 mg ITV every 2-4 weeks, and de-escalated based on toxicity obtained from the Phase I portion of the trial. Metronomic dosing of temozolomide will be given at 75 mg/m2 for 21 days (continuous ora"
10998516|NCT01045031|BG000|Baseline|Marathon Athletes|Participation in more than one of the following competitions during the previous three years: Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km)
10998517|NCT01045031|BG001|Baseline|Controls|The control group was matched according to age, sex and years of education.
10998518|NCT01045031|BG002|Baseline|Total|Total of all reporting groups
10998519|NCT01045031|FG000|Participant Flow|Controls|The control group was matched according to age, sex and years of education.
10998520|NCT01045031|FG001|Participant Flow|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.~The inclusion criteria were~(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
10998521|NCT01045031|OG000|Outcome|Marathon Athletes|Brain-derived Neurotrophic Factor (BDNF)
10998522|NCT01045031|OG001|Outcome|Controls|Brain-derived Neurotrophic Factor (BDNF)
10998523|NCT01045031|OG000|Outcome|Controls|The control group was matched according to age, sex and years of education.
10998524|NCT01045031|OG001|Outcome|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.~The inclusion criteria were~(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
10998525|NCT01045031|OG000|Outcome|Controls|"Controls were subsequently contacted via personal contact and three additional advertisements (two in an Austrian newspaper (Krone) and one in an Austrian bicyclist journal (Bicyclist Sports). The controls were matched according to age, sex and years of education"
10998526|NCT01045031|OG001|Outcome|Marathon Athletes|Runners participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km). Inclusion criteria:1) participation in at least one of these 3 marathons in the preceding two years,2)still in continuous training during the recruitment phase (at least 2 hours/week), 3) aged over 60. Exclusion criteria:(a) present or past exposure to neurotoxic substances (b) if they did not speak German as their native language (c) diseases that markedly affect CNS functions (d) manifest cardiovascular disease, (e) chronic alcoholism (daily alcohol intake > 60 g or diagnosed history of alcoholism) and (f) unwillingness to give informed consent.
10998527|NCT01045031|EG000|Reported Event|Controls|
10998528|NCT01045031|EG001|Reported Event|Athletes|
10998529|NCT01045057|BG000|Baseline|Provox Vega Puncture Set|Group of larynx cancer patients undergoing a total laryngectomy whereby the puncture and placement of the voice prosthesis is done with the Provox Vega Puncture Set
11223956|NCT02357147|EG002|Reported Event|Maintenance Treatment Phase: Amatuximab|Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
11336478|NCT03566979|FG002|Participant Flow|Commercial Naproxen Sodium Tablet 440 mg|Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
10998530|NCT01045057|FG000|Participant Flow|Provox Vega Puncture Set|Patients with laryngeal cancer and a total laryngectomy in whom a puncture was made and a voice prosthesis was placed by means of the Provox Vega Puncture Set
10998531|NCT01045057|OG000|Outcome|Provox Vega Puncture Set|Patients with laryngeal cancer and a total laryngectomy in whom a TE puncture was made and a voice prosthesis was placed by means of the Provox Vega Puncture Set
10998532|NCT01045057|OG000|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
10998533|NCT01045057|OG000|Outcome|Secondary Puncture|Patients who had a secondary puncture
10998534|NCT01045057|EG000|Reported Event|Provox Vega Puncture Set|Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set
10998535|NCT01045096|BG000|Baseline|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
10998536|NCT01045096|BG001|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
10998537|NCT01045096|BG002|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
10998538|NCT01045096|BG003|Baseline|Total|Total of all reporting groups
10998539|NCT01045096|FG000|Participant Flow|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
10998540|NCT01045096|FG001|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
11223957|NCT02357147|EG003|Reported Event|Maintenance Treatment Phase: Placebo|Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
10998541|NCT01045096|FG002|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
10998542|NCT01045096|OG000|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
10998543|NCT01045096|OG001|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
10998544|NCT01045096|OG002|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
11223958|NCT02357173|BG000|Baseline|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
11223959|NCT02357173|BG001|Baseline|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
10998545|NCT01045096|EG000|Reported Event|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
10998546|NCT01045096|EG001|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
10998547|NCT01045096|EG002|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
10998548|NCT01045122|BG000|Baseline|Propofol vs Dexmedetomidine|We aim to study two commonly used sedatives (propofol vs dexmedetomidine) in subjects with OSA for their propensity to produce sedation related respiratory events
10998549|NCT01045122|FG000|Participant Flow|Propofol First|Propofol was administered first in 5/11 subjects with a one week washout at least between the next run with dexmedetomidine
10998550|NCT01045122|FG001|Participant Flow|Dexmedetomidine First|Dexmedetomidine was administered on the first day in 6/11 subjects with at least a one week washout between runs before the subjects underwent the experiment with propofol.
10998551|NCT01045122|OG000|Outcome|Propofol|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
10998552|NCT01045122|OG001|Outcome|Dexmedetomidine|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
10998553|NCT01045122|EG000|Reported Event|Propofol|"Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties.~Propofol: For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained."
10998554|NCT01045122|EG001|Reported Event|Dexmedetomidine|"Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects.~Dexmedetomidine: For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr."
10998555|NCT01045135|BG000|Baseline|First Time Delivery|Women giving birth to their first child
10998556|NCT01045135|FG000|Participant Flow|First Time Delivery|Women giving birth to their first child
10998557|NCT01045135|OG000|Outcome|Primiparous Women Levator Hiatus Area During Valsalva Maneuver|Women giving birth to their first child
10998558|NCT01045135|OG000|Outcome|Primiparous Women Bladder Neck Mobility Rest to Valsalva Maneu|Women giving birth to their first child
10998559|NCT01045135|OG000|Outcome|Primiparous Women Levator Hiatus Area|Women giving birth to their first child
10998560|NCT01045135|EG000|Reported Event|First Time Delivery|Women giving birth to their first child
11007639|NCT01092182|EG000|Reported Event|Group A - Low-risk Burkitt Lymphoma (BL)|"Burkitt lymphoma Low Risk Arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
10998561|NCT01045161|BG000|Baseline|Placebo Part A / Placebo to Aclidinium Bromide 400μg Part B|"Dose-matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks."
10998562|NCT01045161|BG001|Baseline|Aclidinium Bromide(AB) 200μg Part A / AB 200μg to 400μg Part B|"Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks."
10998563|NCT01045161|BG002|Baseline|Aclidinium Bromide(AB) 400μg Part A / AB 400μg to 400μg Part B|"Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks."
10998564|NCT01045161|BG003|Baseline|Total|Total of all reporting groups
10998565|NCT01045161|FG000|Participant Flow|Placebo - Part A Placebo to Aclidinium Bromide 400 μg - Part B|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment. After 12 weeks, patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
10998566|NCT01045161|FG001|Participant Flow|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients who were Aclidinium bromide 200 microgram dose, received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
10998567|NCT01045161|FG002|Participant Flow|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients continued to receive Aclidinium bromide, 400 microgram dose as an open-label treatment for an additional 40 weeks
10998568|NCT01045161|OG000|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
10998569|NCT01045161|OG001|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
11223960|NCT02357173|BG002|Baseline|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
10998570|NCT01045161|OG002|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
10998571|NCT01045161|OG000|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on placebo were switched to open label 400µg aclidinium bromide for 40 weeks
10998572|NCT01045161|OG001|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 200 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg were switched to open label 400µg aclidinium bromide for 40 weeks.
10998573|NCT01045161|OG002|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients received open label 400µg aclidinium bromide for 40 additional weeks
10998574|NCT01045161|OG000|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo switched to open label 400µg aclidinium bromide for 40 weeks
10998575|NCT01045161|OG001|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg switched to open label 400µg aclidinium bromide for 40 weeks
10998576|NCT01045161|OG002|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 400 μg dose, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg switched to open label 400µg aclidinium bromide for 40 weeks
10998577|NCT01045161|EG000|Reported Event|Placebo - Part A|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment.
10998578|NCT01045161|EG001|Reported Event|Aclidinium Bromide 200 μg - Part A|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment.
10998579|NCT01045161|EG002|Reported Event|Aclidinium Bromide 400 μg - Part A|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment.
10998580|NCT01045161|EG003|Reported Event|Placebo to Aclidinium Bromide 400 μg - Part B|After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
10998581|NCT01045161|EG004|Reported Event|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg - Part B|Part B - After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.
10998582|NCT01045161|EG005|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg - Part B|After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.
10998583|NCT01045174|BG000|Baseline|Breath-Actuated Nebulizer|"Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer.~Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices."
11223961|NCT02357173|BG003|Baseline|Total|Total of all reporting groups
11007640|NCT01092182|EG001|Reported Event|Group B - High-Risk Burkitt Lymphoma (BL)|"Burkitt lymphoma High Risk Arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
11336479|NCT03566979|FG003|Participant Flow|Commercial Naproxen Sodium Liquid Gel Capsule 440 mg|Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
10998584|NCT01045174|BG001|Baseline|Conventional Continuous-ouput Nebulizer|"Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer~Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices."
10998585|NCT01045174|BG002|Baseline|Total|Total of all reporting groups
10998586|NCT01045174|FG000|Participant Flow|Breath-Actuated Nebulizer|"Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer.~Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices."
10998587|NCT01045174|FG001|Participant Flow|Conventional Continuous-ouput Nebulizer|"Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer~Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices."
10998588|NCT01045174|OG000|Outcome|Breath-Actuated Nebulizer|"Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer.~Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices."
10998589|NCT01045174|OG001|Outcome|Conventional Continuous-ouput Nebulizer|"Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer~Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices."
10998590|NCT01045174|EG000|Reported Event|Breath-Actuated Nebulizer|"Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer.~Nebulizer (breath-actuated versus conventional continuous-output): Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices."
10998591|NCT01045174|EG001|Reported Event|Conventional Continuous-ouput Nebulizer|"Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer~Nebulizer (breath-actuated versus conventional continuous-output): Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices."
10998592|NCT01045187|BG000|Baseline|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
10998593|NCT01045187|FG000|Participant Flow|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
10998594|NCT01045187|OG000|Outcome|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
10998595|NCT01045187|EG000|Reported Event|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
10998596|NCT01045265|BG000|Baseline|Men on Raltegravir|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
10998597|NCT01045265|FG000|Participant Flow|Men on Raltegravir|HIV-infected men on chronic therapy with raltegravir 400 mg per day as part of antiretroviral therapy regimen.
10998598|NCT01045265|OG000|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
10998599|NCT01045265|EG000|Reported Event|Men on Raltegravir|HIV-infected men receiving chronic therapy with raltegravir 400 mg per day as part of antiretroviral regimen.
10998600|NCT01045421|BG000|Baseline|Phase 1: MLN8237- All Participants|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose-escalation or pancreatic cancer cohort during Phase 1 portion of the study.
10998601|NCT01045421|BG001|Baseline|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
11007641|NCT01092182|EG002|Reported Event|Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)|"Diffuse large B-cell lymphoma (DLBCL) high risk arm~Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles"
10998602|NCT01045421|BG002|Baseline|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
10998603|NCT01045421|BG003|Baseline|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
10998604|NCT01045421|BG004|Baseline|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
10998605|NCT01045421|BG005|Baseline|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
10998606|NCT01045421|BG006|Baseline|Total|Total of all reporting groups
10998607|NCT01045421|FG000|Participant Flow|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998608|NCT01045421|FG001|Participant Flow|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998609|NCT01045421|FG002|Participant Flow|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998610|NCT01045421|FG003|Participant Flow|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998611|NCT01045421|FG004|Participant Flow|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998612|NCT01045421|FG005|Participant Flow|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
10998613|NCT01045421|FG006|Participant Flow|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
10998614|NCT01045421|FG007|Participant Flow|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
10998615|NCT01045421|FG008|Participant Flow|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
10998616|NCT01045421|FG009|Participant Flow|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
10998617|NCT01045421|FG010|Participant Flow|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
10998618|NCT01045421|OG000|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998619|NCT01045421|OG001|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
11336480|NCT03566979|OG000|Outcome|Placebo|Single dose of two Placebo tablets.
10998620|NCT01045421|OG002|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998621|NCT01045421|OG003|Outcome|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998622|NCT01045421|OG004|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
10998623|NCT01045421|OG005|Outcome|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
10998624|NCT01045421|OG000|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
10998625|NCT01045421|OG001|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
10998626|NCT01045421|OG002|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
10998627|NCT01045421|OG003|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
10998628|NCT01045421|OG004|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
10998629|NCT01045421|OG003|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
10998630|NCT01045421|EG000|Reported Event|Phase 1: MLN8237- Dose Escalation|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose escalation cohort during Phase 1 portion of the study.
11223962|NCT02357173|FG000|Participant Flow|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
10998631|NCT01045421|EG001|Reported Event|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
10998632|NCT01045421|EG002|Reported Event|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
10998633|NCT01045421|EG003|Reported Event|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
10998634|NCT01045421|EG004|Reported Event|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
10998635|NCT01045421|EG005|Reported Event|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
10998636|NCT01045421|EG006|Reported Event|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
10998637|NCT01045447|BG000|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
10998638|NCT01045447|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
10998639|NCT01045447|BG002|Baseline|Total|Total of all reporting groups
10998640|NCT01045447|FG000|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
10998641|NCT01045447|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
10998642|NCT01045447|OG000|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
10998643|NCT01045447|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
10998644|NCT01045447|EG000|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
10998645|NCT01045447|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
10998646|NCT01045460|BG000|Baseline|ASCT + MILs|Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.
10998647|NCT01045460|BG001|Baseline|ASCT + MILs + Vaccine|Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.
10998648|NCT01045460|BG002|Baseline|Total|Total of all reporting groups
10998649|NCT01045460|FG000|Participant Flow|ASCT + MILs|"Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.~Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4.~Cyclophosphamide: Administered at 2.5 g/m^2.~Filgrastim: Administered post cyclophosphamide daily until leukapheresis.~Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.~Melphalan: 100 mg/m^2/day given on Days -2 and -1.~Autologous stem cell transplant: Infused on Day 0."
10998650|NCT01045460|FG001|Participant Flow|ASCT + MILs + Vaccine|"Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.~Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4.~Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.~Cyclophosphamide: Administered at 2.5 g/m^2.~Filgrastim: Administered post cyclophosphamide daily until leukapheresis.~Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.~Melphalan: 100 mg/m^2/day given on Days -2"
10998651|NCT01045460|OG000|Outcome|ASCT + MILs|Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.
10998652|NCT01045460|OG001|Outcome|ASCT + MILs + Vaccine|Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.
10998653|NCT01045460|OG000|Outcome|ASCT + MILs|"Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.~Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4.~Cyclophosphamide: Administered at 2.5 g/m^2.~Filgrastim: Administered post cyclophosphamide daily until leukapheresis.~Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.~Melphalan: 100 mg/m^2/day given on Days -2 and -1.~Autologous stem cell transplant: Infused on Day 0."
11223963|NCT02357173|FG001|Participant Flow|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
10998654|NCT01045460|OG001|Outcome|ASCT + MILs + Vaccine|"Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.~Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4.~Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.~Cyclophosphamide: Administered at 2.5 g/m^2.~Filgrastim: Administered post cyclophosphamide daily until leukapheresis.~Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.~Melphalan: 100 mg/m^2/day given on Days -2"
10998655|NCT01045460|EG000|Reported Event|ASCT + MILs|Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.
10998656|NCT01045460|EG001|Reported Event|ASCT + MILs + Vaccine|Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.
10998657|NCT01045499|BG000|Baseline|Adolescents With Morbid Obesity|At the time of enrollment, the adolescents with morbid obesity were aged 13-18 years of age and at the time of surgery, the adolescents were aged 14-19 years of age.
10998658|NCT01045499|FG000|Participant Flow|Laparoscopic Gastric Banding|"Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.~Laparoscopic adjustable gastric banding (Allergan Lap Band): Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing."
10998659|NCT01045499|OG000|Outcome|Laparoscopic Gastric Banding|"Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.~Laparoscopic adjustable gastric banding (Allergan Lap Band): Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing."
10998660|NCT01045499|EG000|Reported Event|Laparoscopic Gastric Banding|"Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.~Laparoscopic adjustable gastric banding (Allergan Lap Band): Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing."
10998661|NCT01045551|BG000|Baseline|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
10998662|NCT01045551|FG000|Participant Flow|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
10998663|NCT01045551|OG000|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
10998664|NCT01045551|OG000|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
10998665|NCT01045551|EG000|Reported Event|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks~The most frequently reported adverse event (AE) was infection. One patient (a 74 year old female) experienced 2 urinary tract infections during the course of the study, and another (a 63 year old female) experienced one urinary tract infection. Two patients experienced upper respiratory infections, which have previously been reported in patients taking apremilast. The second most common AE was loose stool, reported by two patients, which resolved quickly and without recurrence. All AE's were reported as mild and no patient withdrew from the study due to AEs. No patient required dosing modification or discontinuation."
10998666|NCT01045707|BG000|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
10998667|NCT01045707|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
10998668|NCT01045707|BG002|Baseline|Total|Total of all reporting groups
10998669|NCT01045707|FG000|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
11223964|NCT02357173|FG002|Participant Flow|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
10998670|NCT01045707|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
10998671|NCT01045707|OG000|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
10998672|NCT01045707|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
10998673|NCT01045707|EG000|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
10998674|NCT01045707|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
10998675|NCT01045798|BG000|Baseline|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
10998676|NCT01045798|BG001|Baseline|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
10998677|NCT01045798|BG002|Baseline|Total|Total of all reporting groups
10998678|NCT01045798|FG000|Participant Flow|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
10998679|NCT01045798|FG001|Participant Flow|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
10998680|NCT01045798|OG000|Outcome|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
10998681|NCT01045798|OG001|Outcome|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
10998682|NCT01045798|EG000|Reported Event|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
10998683|NCT01045798|EG001|Reported Event|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
10998684|NCT01045967|BG000|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
10998685|NCT01045967|BG001|Baseline|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
10998686|NCT01045967|BG002|Baseline|Total|Total of all reporting groups
10998687|NCT01045967|FG000|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
10998688|NCT01045967|FG001|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
10998689|NCT01045967|OG000|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
10998690|NCT01045967|OG001|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
10998691|NCT01045967|EG000|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
10998692|NCT01045967|EG001|Reported Event|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
10998693|NCT01045993|BG000|Baseline|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
10998694|NCT01045993|BG001|Baseline|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
10998695|NCT01045993|BG002|Baseline|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
10998696|NCT01045993|BG003|Baseline|Oral Placebo|Oral Placebo matching Oral IBU.
10998697|NCT01045993|BG004|Baseline|Total|Total of all reporting groups
10998698|NCT01045993|FG000|Participant Flow|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
10998699|NCT01045993|FG001|Participant Flow|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
10998700|NCT01045993|FG002|Participant Flow|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
10998701|NCT01045993|FG003|Participant Flow|Oral Placebo|Oral Placebo matching Oral IBU.
10998702|NCT01045993|OG000|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
10998703|NCT01045993|OG001|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
10998704|NCT01045993|OG002|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
10998705|NCT01045993|OG003|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
11336481|NCT03566979|OG001|Outcome|Test Naproxen Sodium Tablet (440 mg)|Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
10998706|NCT01045993|EG000|Reported Event|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
10998707|NCT01045993|EG001|Reported Event|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
10998708|NCT01045993|EG002|Reported Event|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
10998709|NCT01045993|EG003|Reported Event|Oral Placebo|Oral Placebo matching Oral IBU.
10998710|NCT01046084|BG000|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
10998711|NCT01046084|BG001|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
10998712|NCT01046084|BG002|Baseline|Total|Total of all reporting groups
10998713|NCT01046084|FG000|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
10998714|NCT01046084|FG001|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
10998715|NCT01046084|OG000|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
10998716|NCT01046084|OG001|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
10998717|NCT01046084|EG000|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
10998718|NCT01046084|EG001|Reported Event|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
10998719|NCT01046110|BG000|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
10998720|NCT01046110|BG001|Baseline|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
10998721|NCT01046110|BG002|Baseline|Total|Total of all reporting groups
10998722|NCT01046110|FG000|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
10998723|NCT01046110|FG001|Participant Flow|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
10998724|NCT01046110|OG000|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
10998725|NCT01046110|OG001|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
10998726|NCT01046110|EG000|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
10998727|NCT01046110|EG001|Reported Event|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
10998728|NCT01046136|BG000|Baseline|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
10998729|NCT01046136|BG001|Baseline|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
10998730|NCT01046136|BG002|Baseline|Total|Total of all reporting groups
10998731|NCT01046136|FG000|Participant Flow|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
10998732|NCT01046136|FG001|Participant Flow|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
10998733|NCT01046136|OG000|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
10998734|NCT01046136|OG001|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
10998735|NCT01046136|OG000|Outcome|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
10998736|NCT01046136|OG001|Outcome|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
10998737|NCT01046136|EG000|Reported Event|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
10998738|NCT01046136|EG001|Reported Event|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
10998739|NCT01046253|BG000|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
10998740|NCT01046253|BG001|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
10998741|NCT01046253|BG002|Baseline|Total|Total of all reporting groups
10998742|NCT01046253|FG000|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
10998743|NCT01046253|FG001|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
10998744|NCT01046253|OG000|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
10998745|NCT01046253|OG001|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
10998746|NCT01046253|EG000|Reported Event|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
10998747|NCT01046253|EG001|Reported Event|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
10998748|NCT01046396|BG000|Baseline|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
10998749|NCT01046396|FG000|Participant Flow|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
10998750|NCT01046396|OG000|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
10998751|NCT01046396|OG001|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
10998752|NCT01046396|OG002|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
10998753|NCT01046396|EG000|Reported Event|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
10998754|NCT01046396|EG001|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
10998755|NCT01046565|BG000|Baseline|Differin® Lotion 0.1% and Differin Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
10998756|NCT01046565|FG000|Participant Flow|Differin® Lotion 0.1% and Differin® Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream - apply topically to the opposite site of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
10998757|NCT01046565|OG000|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
10998758|NCT01046565|OG001|Outcome|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
10998759|NCT01046565|OG000|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
10998760|NCT01046565|OG001|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks
10998761|NCT01046565|OG002|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
10998762|NCT01046565|EG000|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
10998763|NCT01046565|EG001|Reported Event|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
10998764|NCT01046643|BG000|Baseline|Estrogen and Placebo|"Estrogen treatment with Estradiol (E2)~Participants received both an Estradiol capsule (E2) (1mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
10998765|NCT01046643|BG001|Baseline|Progesterone and Placebo|"Progesterone treatment (P10)~Participants received both a Progesterone capsule (P10) (200 mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
10998766|NCT01046643|BG002|Baseline|Total|Total of all reporting groups
10998767|NCT01046643|FG000|Participant Flow|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)~One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day"
10998768|NCT01046643|FG001|Participant Flow|Progesterone Followed by Placebo|"Progesterone (P10) treatment~One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
10998769|NCT01046643|FG002|Participant Flow|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days.
10998770|NCT01046643|FG003|Participant Flow|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
10998771|NCT01046643|OG000|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
10998772|NCT01046643|OG001|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
10998773|NCT01046643|OG002|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
10998774|NCT01046643|OG003|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
10998775|NCT01046643|EG000|Reported Event|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)~One Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day."
10998776|NCT01046643|EG001|Reported Event|Progesterone Followed by Placebo|"Progesterone treatment~One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
10998777|NCT01046643|EG002|Reported Event|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) capsule once a day, at the same time each day, for 90 days.
10998778|NCT01046643|EG003|Reported Event|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
10998779|NCT01046669|BG000|Baseline|Sham|Standard medical care for septic shock
10998780|NCT01046669|BG001|Baseline|Treatment|Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock
10998781|NCT01046669|BG002|Baseline|Total|Total of all reporting groups
10998782|NCT01046669|FG000|Participant Flow|Sham|Standard medical care for septic shock
10998783|NCT01046669|FG001|Participant Flow|Treatment|Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock.
10998784|NCT01046669|OG000|Outcome|Sham|Standard medical care for septic shock
10998785|NCT01046669|OG001|Outcome|Treatment|Two (2) PMX cartridges administered approximately 24 hours apart plus standard medical care for septic shock
10998786|NCT01046669|EG000|Reported Event|Sham|Standard medical care for septic shock
10998787|NCT01046669|EG001|Reported Event|Treatment|Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock.
10998788|NCT01046682|BG000|Baseline|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
10998789|NCT01046682|BG001|Baseline|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
10998790|NCT01046682|BG002|Baseline|Total|Total of all reporting groups
10998791|NCT01046682|FG000|Participant Flow|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
10998792|NCT01046682|FG001|Participant Flow|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
10998793|NCT01046682|OG000|Outcome|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
10998794|NCT01046682|OG001|Outcome|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
10998795|NCT01046682|EG000|Reported Event|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
10998796|NCT01046682|EG001|Reported Event|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
10998797|NCT01046695|BG000|Baseline|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
10998798|NCT01046695|BG001|Baseline|Control Arm|This arm will have standard care for their post operative pain control.
10998799|NCT01046695|BG002|Baseline|Total|Total of all reporting groups
10998800|NCT01046695|FG000|Participant Flow|Control Arm|Once awake from surgery this arm had standard care for 48 hours for their postoperative pain control using each surgeons usual postoperative medications and procedures.
10998801|NCT01046695|FG001|Participant Flow|TENS Unit|Once awake from surgery this arm added the use of the TENS unit for 48 hours in addition to standard care for their postoperative pain control. The TENS unit was set to each patients individual preference which included intensity, frequency and the placement of where they wanted the electrodes.
10998802|NCT01046695|OG000|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
10998803|NCT01046695|OG001|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
10998804|NCT01046695|EG000|Reported Event|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
10998805|NCT01046695|EG001|Reported Event|Control Arm|This arm will have standard care for their post operative pain control.
10998806|NCT01046877|BG000|Baseline|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
10998807|NCT01046877|FG000|Participant Flow|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
10998808|NCT01046877|OG000|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
10998809|NCT01046877|EG000|Reported Event|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
10998810|NCT01046903|BG000|Baseline|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
10998811|NCT01046903|FG000|Participant Flow|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 International Unit (IU)/0.2 milliliter (mL) and 5000 IU/2 mL subcutaneously (s.c) as per registered indications for 5 weeks.
10998812|NCT01046903|OG000|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
10998813|NCT01046903|EG000|Reported Event|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
10998814|NCT01047007|BG000|Baseline|Part 1: MK-1775 65 mg BID|Participants received 65 mg of MK-1775 administered orally twice a day (BID) on Days 1-5 of a 21-day cycle.
10998815|NCT01047007|BG001|Baseline|Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg|Participants received 20 mg of MK-1775 administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle.
10998816|NCT01047007|BG002|Baseline|Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg|Participants received 20 mg of MK-1775 administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle.
10998817|NCT01047007|BG003|Baseline|Parts 2B +3: MK-1775 + 5-FU + CDDP|Participants were to receive 20 mg or 65 mg of MK-1775 administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1.
10998818|NCT01047007|BG004|Baseline|Total|Total of all reporting groups
10998819|NCT01047007|FG000|Participant Flow|Part 1: MK-1775 65 mg BID|Participants received 65 mg of MK-1775 administered orally twice a day (BID) on Days 1-5 of a 21-day cycle.
10998820|NCT01047007|FG001|Participant Flow|Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg|Participants received 20 mg of MK-1775 administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle.
10998821|NCT01047007|FG002|Participant Flow|Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg|Participants received 20 mg of MK-1775 administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle.
10998822|NCT01047007|FG003|Participant Flow|Parts 2B +3: MK-1775 + 5-FU + CDDP|Participants were to receive 20 mg or 65 mg of MK-1775 administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1.
10998823|NCT01047007|OG000|Outcome|Part 1: MK-1775 65 mg BID|Participants received 65 mg of MK-1775 administered orally twice a day (BID) on Days 1-5 of a 21-day cycle.
10998824|NCT01047007|OG001|Outcome|Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg|Participants received 20 mg of MK-1775 administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle.
10998825|NCT01047007|OG002|Outcome|Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg|Participants received 20 mg of MK-1775 administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle.
10998826|NCT01047007|OG003|Outcome|Parts 2B +3: MK-1775 + 5-FU + CDDP|Participants were to receive 20 mg or 65 mg of MK-1775 administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1.
10998827|NCT01047007|OG000|Outcome|Parts 2B +3: MK-1775 + 5-FU + CDDP|Participants were to receive 20 mg or 65 mg of MK-1775 administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1.
10998828|NCT01047007|EG000|Reported Event|Part 1: MK-1775 65 mg BID|Participants received 65 mg of MK-1775 administered orally twice a day (BID) on Days 1-5 of a 21-day cycle.
10998829|NCT01047007|EG001|Reported Event|Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg|Participants received 20 mg of MK-1775 administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle.
10998830|NCT01047007|EG002|Reported Event|Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg|Participants received 20 mg of MK-1775 administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle.
10998831|NCT01047189|BG000|Baseline|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
10998832|NCT01047189|BG001|Baseline|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
10998833|NCT01047189|BG002|Baseline|Total|Total of all reporting groups
10998834|NCT01047189|FG000|Participant Flow|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
10998835|NCT01047189|FG001|Participant Flow|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
10998836|NCT01047189|OG000|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
10998837|NCT01047189|OG001|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
10998838|NCT01047189|EG000|Reported Event|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
10998839|NCT01047189|EG001|Reported Event|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
10998840|NCT01047241|BG000|Baseline|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
10998841|NCT01047241|FG000|Participant Flow|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
10998842|NCT01047241|OG000|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
10998843|NCT01047241|OG000|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
10998844|NCT01047241|OG000|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing sufentanil/ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
10998845|NCT01047241|OG000|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
10998846|NCT01047241|EG000|Reported Event|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
10998847|NCT01047293|BG000|Baseline|All Patients|
10998848|NCT01047293|FG000|Participant Flow|ARM 1 RAD001 5 mg QOD|Patients received 5mg RAD001 with FOLFOX and bevacizumab.
10998849|NCT01047293|FG001|Participant Flow|ARM 2 5mg RAD001 QD|Patients received 5mg RAD001 QD with FOLFOX and bevacizumab.
10998850|NCT01047293|FG002|Participant Flow|ARM 3 10mg RAD001 QD|Patients received 10mg RAD001 QD with FOLFOX and bevacizumab.
10998851|NCT01047293|FG003|Participant Flow|ARM 4 10mg RAD001 QD - Phase II|Patients received 10 mg RAD001 with FOLFOX and bevacizumab. - Patient in the Dose Expansion Cohort not Dose Escalation
10998852|NCT01047293|OG000|Outcome|All Patients|
10998853|NCT01047293|OG000|Outcome|ARM 1 RAD001 5 mg QOD|Patients received 5mg RAD001 with FOLFOX and bevacizumab.
10998854|NCT01047293|OG001|Outcome|ARM 2 5mg RAD001 QD|Patients received 5mg RAD001 QD with FOLFOX and bevacizumab.
10998855|NCT01047293|OG002|Outcome|ARM 3 10mg RAD001 QD|Patients received 10mg RAD001 QD with FOLFOX and bevacizumab.
10998856|NCT01047293|EG000|Reported Event|All Patients|All participants enrolled.
10998857|NCT01047306|BG000|Baseline|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
10998858|NCT01047306|BG001|Baseline|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
10998859|NCT01047306|BG002|Baseline|Total|Total of all reporting groups
10998860|NCT01047306|FG000|Participant Flow|Children < 6 Years Old|Children ≥1 to < 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
10998861|NCT01047306|FG001|Participant Flow|Children ≥ 6 Years Old|Children ≥ 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
10998862|NCT01047306|OG000|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
10998863|NCT01047306|OG001|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
10998864|NCT01047306|OG000|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
10998865|NCT01047306|OG001|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
10998866|NCT01047306|EG000|Reported Event|Children < 6 Years|Patients ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
10998867|NCT01047306|EG001|Reported Event|Children ≥ 6 Years|Patients ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
10998868|NCT01047332|BG000|Baseline|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
10998869|NCT01047332|BG001|Baseline|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
10998870|NCT01047332|BG002|Baseline|Total|Total of all reporting groups
10998871|NCT01047332|FG000|Participant Flow|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
10998872|NCT01047332|FG001|Participant Flow|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
10998873|NCT01047332|OG000|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
10998874|NCT01047332|OG001|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
11336482|NCT03566979|OG002|Outcome|Commercial Naproxen Sodium Tablets (440 mg)|Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
10998875|NCT01047332|EG000|Reported Event|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
10998876|NCT01047332|EG001|Reported Event|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
10998877|NCT01047345|BG000|Baseline|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
10998878|NCT01047345|BG001|Baseline|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
10998879|NCT01047345|BG002|Baseline|Total|Total of all reporting groups
10998880|NCT01047345|FG000|Participant Flow|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
10998881|NCT01047345|FG001|Participant Flow|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
10998882|NCT01047345|FG002|Participant Flow|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
10998883|NCT01047345|OG000|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
10998884|NCT01047345|OG001|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
10998885|NCT01047345|OG000|Outcome|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
10998886|NCT01047345|EG000|Reported Event|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
10998887|NCT01047345|EG001|Reported Event|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
10998888|NCT01047345|EG002|Reported Event|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
10998889|NCT01047358|BG000|Baseline|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
10998890|NCT01047358|FG000|Participant Flow|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
10998891|NCT01047358|OG000|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
10998892|NCT01047358|OG000|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
10998893|NCT01047358|EG000|Reported Event|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
10998894|NCT01047436|BG000|Baseline|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
10998895|NCT01047436|BG001|Baseline|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
10998896|NCT01047436|BG002|Baseline|Total|Total of all reporting groups
10998897|NCT01047436|FG000|Participant Flow|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
10998898|NCT01047436|FG001|Participant Flow|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
10998899|NCT01047436|OG000|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
10998900|NCT01047436|OG001|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
10998901|NCT01047436|EG000|Reported Event|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
10998902|NCT01047436|EG001|Reported Event|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
10998903|NCT01047475|BG000|Baseline|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
10998904|NCT01047475|BG001|Baseline|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
10998905|NCT01047475|BG002|Baseline|Total|Total of all reporting groups
10998906|NCT01047475|FG000|Participant Flow|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
10998907|NCT01047475|FG001|Participant Flow|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
11223965|NCT02357173|OG000|Outcome|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
10998908|NCT01047475|OG000|Outcome|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
10998909|NCT01047475|OG001|Outcome|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
10998910|NCT01047475|EG000|Reported Event|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
10998911|NCT01047475|EG001|Reported Event|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
10998912|NCT01047527|BG000|Baseline|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10998913|NCT01047527|BG001|Baseline|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10998914|NCT01047527|BG002|Baseline|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10998915|NCT01047527|BG003|Baseline|Total|Total of all reporting groups
10998916|NCT01047527|FG000|Participant Flow|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10998917|NCT01047527|FG001|Participant Flow|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10998918|NCT01047527|FG002|Participant Flow|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10998919|NCT01047527|OG000|Outcome|Standard + Extended|participants on standard or extended therapy
10998920|NCT01047527|OG001|Outcome|Maintenance|Participants on 52 weeks of therapy
10998921|NCT01047527|OG000|Outcome|Standard|
10998922|NCT01047527|OG001|Outcome|Extended + Maintenance|
10998923|NCT01047527|EG000|Reported Event|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10998924|NCT01047527|EG001|Reported Event|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10877786|NCT00448916|EG002|Reported Event|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
10877787|NCT00448916|EG003|Reported Event|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
10998925|NCT01047527|EG002|Reported Event|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
10998926|NCT01047553|BG000|Baseline|Formoterol|Formoterol 9 μg twice daily
10998927|NCT01047553|BG001|Baseline|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
10998928|NCT01047553|BG002|Baseline|Total|Total of all reporting groups
10998929|NCT01047553|FG000|Participant Flow|Formoterol|Formoterol 9 μg twice daily
10998930|NCT01047553|FG001|Participant Flow|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
10998931|NCT01047553|OG000|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
10998932|NCT01047553|OG001|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
10998933|NCT01047553|EG000|Reported Event|Formoterol|Formoterol 9 μg twice daily
10998934|NCT01047553|EG001|Reported Event|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
10998935|NCT01047709|BG000|Baseline|All Study Participants|All study participants.
10998936|NCT01047709|FG000|Participant Flow|Positional Therapy Night First, Then Control Night|Avoidance of supine positioning on the first night, followed by a second night of positioning ad lib.
10998937|NCT01047709|FG001|Participant Flow|Control Night First, Then Positional Therapy Night|Position ad lib for the first night, then one night of avoidance of supine positioning.
10998938|NCT01047709|OG000|Outcome|Positional Therapy Night|Avoidance of supine positioning.
10998939|NCT01047709|OG001|Outcome|Control Night|Position ad lib
10998940|NCT01047709|EG000|Reported Event|Positional Therapy Night|Avoidance of supine positioning.
10998941|NCT01047709|EG001|Reported Event|Control Night|Position ad lib
10998942|NCT01047839|BG000|Baseline|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28
10998943|NCT01047839|BG001|Baseline|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
10998944|NCT01047839|BG002|Baseline|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
10998945|NCT01047839|BG003|Baseline|Total|Total of all reporting groups
10998946|NCT01047839|FG000|Participant Flow|>=2 Months to <3 Years|IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
10998947|NCT01047839|FG001|Participant Flow|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
10998948|NCT01047839|FG002|Participant Flow|>=12 to <18 Years|IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
10998949|NCT01047839|OG000|Outcome|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
10998950|NCT01047839|OG001|Outcome|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
10998951|NCT01047839|OG002|Outcome|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
10998952|NCT01047839|OG000|Outcome|IC51 0.25 mL|0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
10998953|NCT01047839|OG001|Outcome|IC51 0.5 mL|0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years
10998954|NCT01047839|OG000|Outcome|>=2 Months to <3 Years|"IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28~IC51: 0.25 ml, 2 i.m. vaccinations at Day 0 and 28"
10998955|NCT01047839|OG001|Outcome|>=3 to <12 Years|"IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28~IC51: 0.5 ml, 2 i.m. vaccinations at Day 0 and 28"
10998956|NCT01047839|OG002|Outcome|>=12 to <18 Years|"IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28~IC51: 0.5 ml, 2 i.m. vaccinations at Day 0 and 28"
10998957|NCT01047839|OG000|Outcome|>=2 Months to <3 Years|IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
10998958|NCT01047839|OG002|Outcome|>=12 to <18 Years|IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
10998959|NCT01047839|EG000|Reported Event|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
10998960|NCT01047839|EG001|Reported Event|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
10998961|NCT01047839|EG002|Reported Event|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
10998962|NCT01048099|BG000|Baseline|Patients Treated|Patients who received study treatment
10998963|NCT01048099|FG000|Participant Flow|All Patients|
10998964|NCT01048099|OG000|Outcome|All Patients Evaluated by PRO Onc Assay|
10998965|NCT01048099|OG000|Outcome|Patients Treated|Patients who received study treatment
10998966|NCT01048099|OG000|Outcome|All Patients|
10998967|NCT01048099|EG000|Reported Event|All Treated Patients|Includes all patients with HER2 overexpression/activation (as identified by the PRO Onc Assay) who received study treatment
10998968|NCT01048242|BG000|Baseline|Ramelteon|Ramelteon 8 mg oral before bedtime
10998969|NCT01048242|BG001|Baseline|Sugar Pill|
10998970|NCT01048242|BG002|Baseline|Total|Total of all reporting groups
10998971|NCT01048242|FG000|Participant Flow|Ramelteon|Ramelteon 8 mg oral before bedtime
10998972|NCT01048242|FG001|Participant Flow|Sugar Pill|
10998973|NCT01048242|OG000|Outcome|Ramelteon|Ramelteon 8 mg oral before bedtime
10998974|NCT01048242|OG001|Outcome|Sugar Pill|
10998975|NCT01048242|EG000|Reported Event|Ramelteon|Ramelteon 8 mg oral before bedtime
10998976|NCT01048242|EG001|Reported Event|Sugar Pill|
10998977|NCT01048333|BG000|Baseline|Entire Study Population|Includes all 3 arms : Formoterol, Salmeterol and Placebo.
10998978|NCT01048333|FG000|Participant Flow|Formoterol, Then Salmeterol, Then Placebo|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
10998979|NCT01048333|FG001|Participant Flow|Salmeterol, Then Palcebo, Then Formoterol|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
10998980|NCT01048333|FG002|Participant Flow|Placebo, Then Formoterol, Then Salmeterol|Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
10998981|NCT01048333|FG003|Participant Flow|Formoterol, Then Placebo, Then Salmeterol|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
10998982|NCT01048333|FG004|Participant Flow|Salmeterol, Then Formoterol, Then Placebo|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
10998983|NCT01048333|FG005|Participant Flow|Placebo, Then Salmeterol, Then Formoterol|Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
10998984|NCT01048333|OG000|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
10998985|NCT01048333|OG001|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
10998986|NCT01048333|OG002|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
10998987|NCT01048333|EG000|Reported Event|Formoterol|Formoterol Turbuhaler 9 mcg
10998988|NCT01048333|EG001|Reported Event|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
10998989|NCT01048333|EG002|Reported Event|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
10998990|NCT01048424|BG000|Baseline|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10998991|NCT01048424|BG001|Baseline|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10998992|NCT01048424|BG002|Baseline|Total|Total of all reporting groups
10998993|NCT01048424|FG000|Participant Flow|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10998994|NCT01048424|FG001|Participant Flow|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10998995|NCT01048424|OG000|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10998996|NCT01048424|OG001|Outcome|Control|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10998997|NCT01048424|OG001|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10998998|NCT01048424|EG000|Reported Event|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10998999|NCT01048424|EG001|Reported Event|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
10999000|NCT01048502|BG000|Baseline|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
10999001|NCT01048502|BG001|Baseline|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
11336483|NCT03566979|OG003|Outcome|Commercial Naproxen Sodium Liquid Gel Capsules (440 mg)|Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
10999002|NCT01048502|BG002|Baseline|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
10999003|NCT01048502|BG003|Baseline|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
10999004|NCT01048502|BG004|Baseline|Total|Total of all reporting groups
10999005|NCT01048502|FG000|Participant Flow|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor) tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
10999006|NCT01048502|FG001|Participant Flow|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
10999007|NCT01048502|FG002|Participant Flow|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
10999008|NCT01048502|FG003|Participant Flow|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
10999009|NCT01048502|OG000|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
10999010|NCT01048502|OG001|Outcome|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
10999011|NCT01048502|OG002|Outcome|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
10999012|NCT01048502|OG000|Outcome|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
10999013|NCT01048502|OG001|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
10999014|NCT01048502|EG000|Reported Event|Tricor (145 mg/Day)|"Participants will be given 1 Tricor 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
10999015|NCT01048502|EG001|Reported Event|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
10999016|NCT01048502|EG002|Reported Event|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
10999017|NCT01048502|EG003|Reported Event|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
11336484|NCT03566979|EG000|Reported Event|Placebo|Single dose of two Placebo tablets.
10999018|NCT01048541|BG000|Baseline|Entire Study|Includes groups randomized to standard catheter first and test catheter first
10999019|NCT01048541|FG000|Participant Flow|AB: First Test Catheter Then Standard Catheter|Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period
10999020|NCT01048541|FG001|Participant Flow|BA: First Standard Catheter Then Test Catheter|Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period
10999021|NCT01048541|OG000|Outcome|Test Catheter|Test catheter (SpeediCath Compact Male)
10999022|NCT01048541|OG001|Outcome|Standard Catheter|Standard catheter (SpediCath straight)
10999023|NCT01048541|EG000|Reported Event|Test Catheter|Test catheter (SpeediCath Compact Male)
10999024|NCT01048541|EG001|Reported Event|Standard Catheter|Standard catheter (SpediCath straight)
10999025|NCT01048593|BG000|Baseline|Dose 1|114ug dose group
10999026|NCT01048593|BG001|Baseline|Dose 2|513ug dose group
10999027|NCT01048593|BG002|Baseline|Dose 3|684ug dose group
10999028|NCT01048593|BG003|Baseline|Total|Total of all reporting groups
10999029|NCT01048593|FG000|Participant Flow|Dose 1|114ug dose group
10999030|NCT01048593|FG001|Participant Flow|Dose 2|513ug dose group
10999031|NCT01048593|FG002|Participant Flow|Dose 3|684ug dose group
10999032|NCT01048593|OG000|Outcome|Dose 1|"114ug~IBI-10090: Single intraocular injection"
10999033|NCT01048593|OG001|Outcome|Dose 2|"513ug~IBI-10090: Single intraocular injection"
10999034|NCT01048593|OG002|Outcome|Dose 3|"684ug~IBI-10090: Single intraocular injection"
10999035|NCT01048593|EG000|Reported Event|Dose 1|114ug dose group
10999036|NCT01048593|EG001|Reported Event|Dose 2|513ug dose group
10999037|NCT01048593|EG002|Reported Event|Dose 3|684ug dose group
10999038|NCT01048606|BG000|Baseline|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
10999039|NCT01048606|BG001|Baseline|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
10999040|NCT01048606|BG002|Baseline|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
10999041|NCT01048606|BG003|Baseline|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
10999042|NCT01048606|BG004|Baseline|Total|Total of all reporting groups
10999043|NCT01048606|FG000|Participant Flow|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
10999044|NCT01048606|FG001|Participant Flow|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
10999045|NCT01048606|FG002|Participant Flow|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
10999046|NCT01048606|FG003|Participant Flow|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
10999047|NCT01048606|OG000|Outcome|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
10999048|NCT01048606|OG001|Outcome|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
10999049|NCT01048606|OG002|Outcome|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
10999050|NCT01048606|OG003|Outcome|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
10999051|NCT01048606|EG000|Reported Event|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
10999052|NCT01048606|EG001|Reported Event|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
10999053|NCT01048606|EG002|Reported Event|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
10999054|NCT01048606|EG003|Reported Event|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
10999055|NCT01048658|BG000|Baseline|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
10999056|NCT01048658|BG001|Baseline|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
10999057|NCT01048658|BG002|Baseline|Total|Total of all reporting groups
10999058|NCT01048658|FG000|Participant Flow|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
10999059|NCT01048658|FG001|Participant Flow|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
10999060|NCT01048658|OG000|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
10999061|NCT01048658|OG001|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
10999062|NCT01048658|EG000|Reported Event|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
10999063|NCT01048658|EG001|Reported Event|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
10999064|NCT01048671|BG000|Baseline|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999065|NCT01048671|BG001|Baseline|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
10999066|NCT01048671|BG002|Baseline|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
10999067|NCT01048671|BG003|Baseline|Total|Total of all reporting groups
10999068|NCT01048671|FG000|Participant Flow|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999069|NCT01048671|FG001|Participant Flow|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999070|NCT01048671|FG002|Participant Flow|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999071|NCT01048671|OG000|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999072|NCT01048671|OG000|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999073|NCT01048671|OG001|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999074|NCT01048671|OG002|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999075|NCT01048671|OG003|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999076|NCT01048671|EG000|Reported Event|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
10999077|NCT01048697|BG000|Baseline|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
10999078|NCT01048697|FG000|Participant Flow|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
10999079|NCT01048697|OG000|Outcome|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
10999080|NCT01048697|EG000|Reported Event|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
10999081|NCT01048788|BG000|Baseline|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
10999082|NCT01048788|BG001|Baseline|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
10999083|NCT01048788|BG002|Baseline|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
10999084|NCT01048788|BG003|Baseline|Total|Total of all reporting groups
10999085|NCT01048788|FG000|Participant Flow|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
10999086|NCT01048788|FG001|Participant Flow|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
10999087|NCT01048788|FG002|Participant Flow|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
10999088|NCT01048788|OG000|Outcome|Discontitued/Terminated Before Day 8|Subjects who discontinued treatment before Day 7 or teiminated by meeting the criteria on Day 7
10999089|NCT01048788|OG001|Outcome|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
10999090|NCT01048788|OG002|Outcome|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
10999091|NCT01048788|EG000|Reported Event|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
11336485|NCT03566979|EG001|Reported Event|Test Naproxen Sodium 440 Milligram (mg)|Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
10999092|NCT01048788|EG001|Reported Event|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
10999093|NCT01048788|EG002|Reported Event|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
10999094|NCT01048866|BG000|Baseline|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
10999095|NCT01048866|BG001|Baseline|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
10999096|NCT01048866|BG002|Baseline|Total|Total of all reporting groups
10999097|NCT01048866|FG000|Participant Flow|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
10999098|NCT01048866|FG001|Participant Flow|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
10999099|NCT01048866|OG000|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
10999100|NCT01048866|OG001|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
10999101|NCT01048866|EG000|Reported Event|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
10999102|NCT01048866|EG001|Reported Event|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
10999103|NCT01048879|BG000|Baseline|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
10999104|NCT01048879|BG001|Baseline|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
10999105|NCT01048879|BG002|Baseline|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
10999106|NCT01048879|BG003|Baseline|Total|Total of all reporting groups
10999107|NCT01048879|FG000|Participant Flow|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
10999108|NCT01048879|FG001|Participant Flow|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
10999109|NCT01048879|FG002|Participant Flow|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
10999110|NCT01048879|OG000|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
10999111|NCT01048879|OG001|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
10999112|NCT01048879|OG002|Outcome|ECMO Alone|Patients receiving ECMO only
10999113|NCT01048879|EG000|Reported Event|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
10999114|NCT01048879|EG001|Reported Event|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
11336486|NCT03566979|EG002|Reported Event|Commercial Naproxen Sodium Tablet 440 mg|Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
10999115|NCT01048879|EG002|Reported Event|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
10999116|NCT01048905|BG000|Baseline|Treatment: L-glutamine|"Patients will receive an 8-week course of oral L-glutamine 10 grams TID~L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age."
10999117|NCT01048905|FG000|Participant Flow|Treatment: L-glutamine|"Patients will receive an 8-week course of oral L-glutamine 10 grams TID~L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age."
10999118|NCT01048905|OG000|Outcome|Treatment: L-glutamine|"Patients will receive an 8-week course of oral L-glutamine 10 grams TID~L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age."
10999119|NCT01048905|EG000|Reported Event|Treatment: L-glutamine|"Patients will receive an 8-week course of oral L-glutamine 10 grams TID~L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age."
10999120|NCT01048944|BG000|Baseline|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
10999121|NCT01048944|BG001|Baseline|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
10999122|NCT01048944|BG002|Baseline|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
10999123|NCT01048944|BG003|Baseline|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
10999124|NCT01048944|BG004|Baseline|Total|Total of all reporting groups
10999125|NCT01048944|FG000|Participant Flow|Bupropion Sustained Release (SR)|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
10999126|NCT01048944|FG001|Participant Flow|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
10999127|NCT01048944|FG002|Participant Flow|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
10999128|NCT01048944|FG003|Participant Flow|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
10999129|NCT01048944|OG000|Outcome|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
10999130|NCT01048944|OG001|Outcome|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
10999131|NCT01048944|OG002|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
10999132|NCT01048944|OG003|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
10999133|NCT01048944|EG000|Reported Event|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill, 3 days 1x/day then 56 days at 2x/day, then 3 day at 1x/day ramp-down."
10999134|NCT01048944|EG001|Reported Event|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
10999135|NCT01048944|EG002|Reported Event|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56 days at 2x/day, then 3 days at 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
10999136|NCT01048944|EG003|Reported Event|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
10999137|NCT01049009|BG000|Baseline|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
10999138|NCT01049009|BG001|Baseline|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
10999139|NCT01049009|BG002|Baseline|Total|Total of all reporting groups
10999140|NCT01049009|FG000|Participant Flow|Nebivolol/Metoprolol XL|Subjects are randomized to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after cross over.
10999141|NCT01049009|FG001|Participant Flow|Metoprolol XL/Nebivolol|Subjects are randomized to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after cross over.
10999142|NCT01049009|OG000|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
10999143|NCT01049009|OG001|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
10999144|NCT01049009|EG000|Reported Event|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
10999145|NCT01049009|EG001|Reported Event|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
10999146|NCT01049217|BG000|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
10999147|NCT01049217|BG001|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
10999148|NCT01049217|BG002|Baseline|Total|Total of all reporting groups
10999149|NCT01049217|FG000|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
10999150|NCT01049217|FG001|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
11007642|NCT01092195|BG000|Baseline|Transplant With Immunosuppression|Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
10999151|NCT01049217|OG000|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
10999152|NCT01049217|OG001|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
10999153|NCT01049217|EG000|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
10999154|NCT01049217|EG001|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
10999155|NCT01049243|BG000|Baseline|Single Group|
10999156|NCT01049243|FG000|Participant Flow|Vanos|Single group; 0.1% Cream, One Application, Twice Daily, 14 Days
10999157|NCT01049243|OG000|Outcome|Single Group|
10999158|NCT01049243|OG000|Outcome|Fluocinonide Cream 0.1%|"Fluocinonide Cream 0.1% open label~Fluocinonide Cream 0.1%: 0.1% Cream, One Application, Twice Daily, 14 Days"
10999159|NCT01049243|EG000|Reported Event|Single Group|
10999160|NCT01049308|BG000|Baseline|Group 1|veteran population with documented heart failure
10999161|NCT01049308|FG000|Participant Flow|Heart Failure|veteran population with documented heart failure
10999162|NCT01049308|OG000|Outcome|Heart Failure|veteran population with documented heart failure
10999163|NCT01049308|OG000|Outcome|No CI|veteran population with documented heart failure with no cognitive impairment on SLUMS screening test who finished 30-day pill counts
10999164|NCT01049308|OG001|Outcome|Mild CI|veteran population with documented heart failure with mild cognitive impairment on SLUMS screening test who finished 30-day pill counts
10999165|NCT01049308|OG002|Outcome|Severe CI|veteran population with documented heart failure with severe cognitive impairment (dementia) on SLUMS screening test who finished 30-day pill counts
10999166|NCT01049308|EG000|Reported Event|Group 1|veteran population with documented heart failure
10999167|NCT01049334|BG000|Baseline|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
11223966|NCT02357173|OG001|Outcome|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
11336487|NCT03566979|EG003|Reported Event|Commercial Naproxen Sodium Liquid Gel Capsule 440 mg|Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
10999168|NCT01049334|BG001|Baseline|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
10999169|NCT01049334|BG002|Baseline|Total|Total of all reporting groups
10999170|NCT01049334|FG000|Participant Flow|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
10999171|NCT01049334|FG001|Participant Flow|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
10999172|NCT01049334|OG000|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
10999173|NCT01049334|OG001|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
10999174|NCT01049334|EG000|Reported Event|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
10999175|NCT01049334|EG001|Reported Event|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
10999176|NCT01049360|BG000|Baseline|Overall Population|Safety population defined as all randomized patients who took at least one dose of double-blind investigational product
10999177|NCT01049360|FG000|Participant Flow|Sequence 1|Aclidiunium/Formoterol 400/6 - Aclidiunium/Formoterol 400/12 - Aclidinium - Formoterol
10999178|NCT01049360|FG001|Participant Flow|Sequence 2|Aclidinium/Formoterol 400/12 - Aclidinium - Formoterol - Placebo
10999179|NCT01049360|FG002|Participant Flow|Sequence 3|Aclidinium - Formoterol - Placebo - Aclidinium/Formoterol 400/6
10999180|NCT01049360|FG003|Participant Flow|Sequence 4|Formoterol - Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12
10999181|NCT01049360|FG004|Participant Flow|Sequence 5|Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12 - Aclidinium
10999182|NCT01049360|FG005|Participant Flow|Sequence 6|Aclidinium/Formoterol 400/6 - Aclidinium - Placebo - Aclidinium/Formoterol 400/12
10999183|NCT01049360|FG006|Participant Flow|Sequence 7|Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium
10999184|NCT01049360|FG007|Participant Flow|Sequence 8|Aclidinium - Placebo - Aclidinium/Formoterol 400/12 - Formoterol
10999185|NCT01049360|FG008|Participant Flow|Sequence 9|Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium - Placebo
10999186|NCT01049360|FG009|Participant Flow|Sequence 10|Placebo - Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6
10999187|NCT01049360|FG010|Participant Flow|Sequence 11|Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12 - Placebo
10999188|NCT01049360|FG011|Participant Flow|Sequence 12|Aclidinium/Formoterol 400/12 - Placebo - Aclidinium - Aclidinium/Formoterol 400/6
10999189|NCT01049360|FG012|Participant Flow|Sequence 13|Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12
10999190|NCT01049360|FG013|Participant Flow|Sequence 14|Formoterol - Aclidinium/Formoterol 400/12 - Placebo - Aclidinium
10999191|NCT01049360|FG014|Participant Flow|Sequence 15|Placebo - Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol
10999192|NCT01049360|FG015|Participant Flow|Sequence 16|Aclidinium/Formoterol 400/6 - Placebo - Formoterol - Aclidinium
10999193|NCT01049360|FG016|Participant Flow|Sequence 17|Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo - Formoterol
10999194|NCT01049360|FG017|Participant Flow|Sequence 18|Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo
10999195|NCT01049360|FG018|Participant Flow|Sequence 19|Formoterol - Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6
10999196|NCT01049360|FG019|Participant Flow|Sequence 20|Placebo - Formoterol - Aclidinium - Aclidinium/Formoterol 400/12
10999197|NCT01049360|OG000|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
10999198|NCT01049360|OG001|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
10999199|NCT01049360|OG002|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
10999200|NCT01049360|OG003|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
10999201|NCT01049360|OG004|Outcome|Placebo|Placebo twice-daily
10999202|NCT01049360|EG000|Reported Event|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
10999203|NCT01049360|EG001|Reported Event|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
10999204|NCT01049360|EG002|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
10999205|NCT01049360|EG003|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
10999206|NCT01049360|EG004|Reported Event|Placebo|Placebo twice-daily
10999207|NCT01049373|BG000|Baseline|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10999208|NCT01049373|BG001|Baseline|Placebo Solution|10 drops t.i.d. for 15 weeks
10999209|NCT01049373|BG002|Baseline|Total|Total of all reporting groups
10999210|NCT01049373|FG000|Participant Flow|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10999211|NCT01049373|FG001|Participant Flow|Placebo Solution|10 drops t.i.d. for 15 weeks
10999212|NCT01049373|OG000|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10999213|NCT01049373|OG001|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
10999214|NCT01049373|OG000|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10999215|NCT01049373|OG001|Outcome|PLACEBO Solution|10 drops t.i.d. for 15 weeks
10999216|NCT01049373|EG000|Reported Event|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10999217|NCT01049373|EG001|Reported Event|Placebo Solution|10 drops t.i.d. for 15 weeks
10999218|NCT01049412|BG000|Baseline|LY2605541/Glargine|Participants took LY2605541 in Period I and Glargine in Period II
10999219|NCT01049412|BG001|Baseline|Glargine/LY2605541|Participants took Glargine in Period I and LY2605541 in Period II
10999220|NCT01049412|BG002|Baseline|Total|Total of all reporting groups
10999221|NCT01049412|FG000|Participant Flow|LY2605541/Glargine|Participants took LY2605541 in Period I and Glargine in Period II
10999222|NCT01049412|FG001|Participant Flow|Glargine/LY2605541|Participants took Glargine in Period I and LY2605541 in Period II
10999223|NCT01049412|OG000|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
10999224|NCT01049412|OG001|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
10999225|NCT01049412|OG000|Outcome|LY2605541/Glargine|Participants took LY2605541 in Period I and Glargine in Period II
10999226|NCT01049412|OG001|Outcome|Glargine/LY2605541|Participants took Glargine in Period I and LY2605541 in Period II
10999227|NCT01049412|EG000|Reported Event|LY2605541|Participants took LY2605541 administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks
10999228|NCT01049412|EG001|Reported Event|Glargine|Participants took Glargine administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks
10999229|NCT01049503|BG000|Baseline|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999230|NCT01049503|BG001|Baseline|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999231|NCT01049503|BG002|Baseline|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999232|NCT01049503|BG003|Baseline|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
10999233|NCT01049503|BG004|Baseline|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
10999234|NCT01049503|BG005|Baseline|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
10999235|NCT01049503|BG006|Baseline|Total|Total of all reporting groups
10999236|NCT01049503|FG000|Participant Flow|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999237|NCT01049503|FG001|Participant Flow|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999238|NCT01049503|FG002|Participant Flow|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999239|NCT01049503|FG003|Participant Flow|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
11223967|NCT02357173|OG002|Outcome|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
10999240|NCT01049503|FG004|Participant Flow|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
10999241|NCT01049503|FG005|Participant Flow|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
10999242|NCT01049503|OG000|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
10999243|NCT01049503|OG001|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
10999244|NCT01049503|OG002|Outcome|1100 ppmF , pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
10999245|NCT01049503|OG000|Outcome|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999246|NCT01049503|OG001|Outcome|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999247|NCT01049503|OG002|Outcome|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999248|NCT01049503|OG000|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999249|NCT01049503|OG001|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999250|NCT01049503|OG002|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999251|NCT01049503|OG000|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
10999252|NCT01049503|OG001|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
11336488|NCT03567005|BG000|Baseline|Overall|Nelfilcon A digital contact lenses and nelfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
10999253|NCT01049503|OG002|Outcome|1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
10999254|NCT01049503|OG000|Outcome|Caries-inactive 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999255|NCT01049503|OG001|Outcome|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999256|NCT01049503|OG002|Outcome|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999257|NCT01049503|EG000|Reported Event|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999258|NCT01049503|EG001|Reported Event|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999259|NCT01049503|EG002|Reported Event|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
10999260|NCT01049503|EG003|Reported Event|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
10999261|NCT01049503|EG004|Reported Event|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
10999262|NCT01049503|EG005|Reported Event|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
10999263|NCT01049581|BG000|Baseline|Pediatric Aquatic Therapy Group|The participants were classified into two groups the pediatric aquatic therapy group according the their preference. The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs.
10999264|NCT01049581|BG001|Baseline|Conventional Therapy Group|The participants were classified into the control (conventional therapy) group according to preference. The children included in the control group continued with their original rehabilitation programs.
10999265|NCT01049581|BG002|Baseline|Total|Total of all reporting groups
10999266|NCT01049581|FG000|Participant Flow|Pediatric Aquatic Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the pediatric aquatic therapy according to preference
11223968|NCT02357173|EG000|Reported Event|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
10845207|NCT00265564|EG000|Reported Event|Seeking Safety|"Seeking Safety is a manualized, empirically supported, cognitive behavioral therapy that treats substance use disorders and comorbid PTSD. Participants assigned to the Seeking Safety arm attend two one hour sessions of group therapy for 12 weeks.~Modified Seeking Safety integrated into std outpatient SUD care: The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks."
10999267|NCT01049581|FG001|Participant Flow|Conventional Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the conventional therapy according to preference
10999268|NCT01049581|OG000|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic cerebral palsy participate to pediatric aquatic therapy according preference and finally 11 children complete the study
10999269|NCT01049581|OG001|Outcome|Conventional Therapy|Initially 14 children diagnosed as spastic cerebral palsy participate conventional therapy according to preference and 13 children complete the study
10999270|NCT01049581|OG000|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic type cerebral palsy participate pediatric auqatic therapy and 11 children finish the study,each of them fulfill the the questionnaire before and after the intervention
10999271|NCT01049581|OG001|Outcome|Conventional Therapy|14 children diagnosed as spastic type cerebral palsy participate conventional therapy and 13 children finish the study,each of them fulfill the the questionnaire before and after the intervention
10999272|NCT01049581|OG000|Outcome|Pediatric Aquatic Therapy|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate pediatric aquatic therapy according preference
10999273|NCT01049581|OG001|Outcome|Conventional Therapy|Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate conventional therapy according preference
10999274|NCT01049581|EG000|Reported Event|Effects of Pediatric Aquatic Therapy on Motor Performance|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,
10999275|NCT01049776|BG000|Baseline|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
10999276|NCT01049776|FG000|Participant Flow|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
10999277|NCT01049776|OG000|Outcome|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
10999278|NCT01049776|EG000|Reported Event|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
10845208|NCT00265564|EG001|Reported Event|Usual Care|"Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.~Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence."
10999279|NCT01049802|BG000|Baseline|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
10999280|NCT01049802|BG001|Baseline|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
10999281|NCT01049802|BG002|Baseline|Total|Total of all reporting groups
11223969|NCT02357173|EG001|Reported Event|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
10999282|NCT01049802|FG000|Participant Flow|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
10999283|NCT01049802|FG001|Participant Flow|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
10999284|NCT01049802|OG000|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
10999285|NCT01049802|OG001|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
10999286|NCT01049802|EG000|Reported Event|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
10999287|NCT01049802|EG001|Reported Event|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
10999288|NCT01049919|BG000|Baseline|Concentrated Bone Marrow Aspirate (cBMA)|Bone marrow concentration device: Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
10999289|NCT01049919|BG001|Baseline|Placebo Control (Sham)|Placebo procedure (sham): Sham bone marrow aspiration, sham delivery to affected limb
10999290|NCT01049919|BG002|Baseline|Total|Total of all reporting groups
10999291|NCT01049919|FG000|Participant Flow|Concentrated Bone Marrow Aspirate (cBMA)|Bone marrow concentration device: Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
10999292|NCT01049919|FG001|Participant Flow|Placebo Control (Sham)|Placebo procedure (sham): Sham bone marrow aspiration, sham delivery to affected limb
11223970|NCT02357173|EG002|Reported Event|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
11223971|NCT02357264|BG000|Baseline|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
11223972|NCT02357264|BG001|Baseline|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
10999293|NCT01049919|OG000|Outcome|Concentrated Bone Marrow Aspirate (cBMA)|Bone marrow concentration device: Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
10999294|NCT01049919|OG001|Outcome|Placebo Control (Sham)|Placebo procedure (sham): Sham bone marrow aspiration, sham delivery to affected limb
10999295|NCT01049919|EG000|Reported Event|Concentrated Bone Marrow Aspirate (cBMA)|Bone marrow concentration device: Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
10999296|NCT01049919|EG001|Reported Event|Placebo Control (Sham)|Placebo procedure (sham): Sham bone marrow aspiration, sham delivery to affected limb
10999297|NCT01049945|BG000|Baseline|Phase I|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
10999298|NCT01049945|BG001|Baseline|Maximum Tolerated Dose, Dose Level 4|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
10999299|NCT01049945|BG002|Baseline|Total|Total of all reporting groups
10999300|NCT01049945|FG000|Participant Flow|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999301|NCT01049945|FG001|Participant Flow|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999302|NCT01049945|FG002|Participant Flow|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999303|NCT01049945|FG003|Participant Flow|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
11223973|NCT02357264|BG002|Baseline|Total|Total of all reporting groups
11223974|NCT02357264|FG000|Participant Flow|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
10999304|NCT01049945|FG004|Participant Flow|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999305|NCT01049945|FG005|Participant Flow|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999306|NCT01049945|OG000|Outcome|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999307|NCT01049945|OG001|Outcome|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999308|NCT01049945|OG002|Outcome|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999309|NCT01049945|OG003|Outcome|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999310|NCT01049945|OG004|Outcome|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999311|NCT01049945|OG000|Outcome|Maximum Tolerated Dose, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11223975|NCT02357264|FG001|Participant Flow|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
10999312|NCT01049945|EG000|Reported Event|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999313|NCT01049945|EG001|Reported Event|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999314|NCT01049945|EG002|Reported Event|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999315|NCT01049945|EG003|Reported Event|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999316|NCT01049945|EG004|Reported Event|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999317|NCT01049945|EG005|Reported Event|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
10999318|NCT01049984|BG000|Baseline|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
10999319|NCT01049984|BG001|Baseline|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
10999320|NCT01049984|BG002|Baseline|Total|Total of all reporting groups
10999321|NCT01049984|FG000|Participant Flow|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
10999322|NCT01049984|FG001|Participant Flow|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
10999323|NCT01049984|OG000|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
10999324|NCT01049984|OG001|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
10999325|NCT01049984|EG000|Reported Event|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
10999326|NCT01049984|EG001|Reported Event|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
10999327|NCT01050062|BG000|Baseline|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
10999328|NCT01050062|BG001|Baseline|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
10999329|NCT01050062|BG002|Baseline|Total|Total of all reporting groups
10999330|NCT01050062|FG000|Participant Flow|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
10999331|NCT01050062|FG001|Participant Flow|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
10999332|NCT01050062|OG000|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
10999333|NCT01050062|OG001|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
10999334|NCT01050062|OG002|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
10999335|NCT01050062|EG000|Reported Event|Combination Tablet Ap|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
10999336|NCT01050062|EG001|Reported Event|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
10999337|NCT01050062|EG002|Reported Event|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
10999338|NCT01050153|BG000|Baseline|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
10999339|NCT01050153|BG001|Baseline|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
10999340|NCT01050153|BG002|Baseline|Total|Total of all reporting groups
10999341|NCT01050153|FG000|Participant Flow|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
10999342|NCT01050153|FG001|Participant Flow|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
10999343|NCT01050153|OG000|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
10999344|NCT01050153|OG001|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
10999345|NCT01050153|EG000|Reported Event|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
10999346|NCT01050153|EG001|Reported Event|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
10999347|NCT01050205|BG000|Baseline|Current Intervention|"At enrollment, participants are randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
10999348|NCT01050205|BG001|Baseline|Delayed Intervention|"At enrollment, participants are randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
10999349|NCT01050205|BG002|Baseline|Total|Total of all reporting groups
10999350|NCT01050205|FG000|Participant Flow|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
10999351|NCT01050205|FG001|Participant Flow|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
10845209|NCT00265616|BG000|Baseline|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
10999352|NCT01050205|OG000|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
11007643|NCT01092195|BG001|Baseline|Transplant With no Immunosuppression|Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007644|NCT01092195|BG002|Baseline|Healthy Volunteer|Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007645|NCT01092195|BG003|Baseline|Total|Total of all reporting groups
10999353|NCT01050205|OG001|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
10999354|NCT01050205|EG000|Reported Event|Current Intervention|No unexpected or unanticipated adverse events occurred in the Current Intervention group.
10999355|NCT01050205|EG001|Reported Event|Delayed Intervention|No unexpected or unanticipated adverse events occurred in the Delayed Intervention group.
10999356|NCT01050231|BG000|Baseline|Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises)|"Robotic group (Type I)~Type I Robotic Group (Functional activities and individual joints): Subjects participate in 11 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program involving multiple joints at the same time for the functional activities such as cleaning the window, driving a steering wheel, grocery shopping, etc; and then individual joint exercises focusing on one joint at a time with the individual joint exercises."
10999357|NCT01050231|BG001|Baseline|Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities)|"Robotic group (Type II)~Type II Robotic therapy (Individual joints exercises then functional activities): Subjects participate in 11 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements as the patient perform individual joint exercises focusing on one joint at a time; and then functional activities like cleaning the window, driving a steering wheel, grocery shopping, etc for the functional activities."
10999358|NCT01050231|BG002|Baseline|Total|Total of all reporting groups
10999359|NCT01050231|FG000|Participant Flow|Individual Joints and Functional Multi-joints Tasks|"Robotic group(Type I)~Type II Robotic therapy (Individual joints only): Subjects participate in 11 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements as the patient play interactive computer games."
10999360|NCT01050231|FG001|Participant Flow|Functional Multi-joints Activities and Individual Joints|"Robotic group (Type II)~Type I Robotic Group (Functional activities and individual joints): Subjects participate in 11 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder) , 3 days per week, 1 hour per day with the robotic exercise program."
10999361|NCT01050231|OG000|Outcome|Functional Multi-joint Training Then Individual Joint Training|Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program which focuses on functional multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc. Then, subjects performed individual joint exercises focusing on one joint at a time for another 4 weeks with 3 days per week and 1 hour per day with the robot-assisted exercise program.
10999362|NCT01050231|OG001|Outcome|Individual Joint Training Then Functional Multi-joint Training|Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program which focuses on individual joint exercises, one joint at a time. Then, subjects performed the multi-joint functional training exercises for another 4 weeks with 3 days per week and 1 hour per day focusing on multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc.
10999363|NCT01050231|EG000|Reported Event|Individual Joints|"Robotic group(Type I)~Type II Robotic therapy (Individual joints only): Subjects participate in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements focusing on one joint at a time. Then, after one-week of a rest break, all subjects will return to participate in another 4 weeks of training with BONES again, 3 days per week with 1 hour per day, focusing on multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc."
10999364|NCT01050231|EG001|Reported Event|Functional Multi-Joint Activities|"Robotic group (Type II)~Type I Robotic Group (Functional Multi-joint activities): Subjects participate in 4 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program focusing on multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc. Then, after a one-week rest break, all subjects will return to participate in another 4 weeks of training with BONES again, 3 days per week with 1 hour per day, focusing on individual joint exercises with one joint at a time."
10999365|NCT01050257|BG000|Baseline|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
10877788|NCT00448916|EG004|Reported Event|Overall|This arm summarizes the AE data from all the treatment groups.
10999366|NCT01050257|BG001|Baseline|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
11223976|NCT02357264|OG000|Outcome|Pregnant Females Without Pre-Eclampsia|Pregnant Females who the OB/GYN physician suspects do not have pre-eclampsia
10999367|NCT01050257|BG002|Baseline|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
10999368|NCT01050257|BG003|Baseline|Total|Total of all reporting groups
10999369|NCT01050257|FG000|Participant Flow|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
10999370|NCT01050257|FG001|Participant Flow|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
10999371|NCT01050257|FG002|Participant Flow|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
10999372|NCT01050257|OG000|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
10999373|NCT01050257|OG001|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
10999374|NCT01050257|OG002|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
10999375|NCT01050257|EG000|Reported Event|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
10999376|NCT01050257|EG001|Reported Event|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
10999377|NCT01050257|EG002|Reported Event|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
10999378|NCT01050530|BG000|Baseline|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
10999379|NCT01050530|BG001|Baseline|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
10999380|NCT01050530|BG002|Baseline|Total|Total of all reporting groups
10999381|NCT01050530|FG000|Participant Flow|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
10999382|NCT01050530|FG001|Participant Flow|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
10999383|NCT01050530|OG000|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
10999384|NCT01050530|OG001|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
10999385|NCT01050530|EG000|Reported Event|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
10999386|NCT01050530|EG001|Reported Event|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
10999387|NCT01050543|BG000|Baseline|Sugammadex|sugammadex 2 mg/kg
10999388|NCT01050543|BG001|Baseline|Neostigmine|neostigmine 50 mcg/kg
10999389|NCT01050543|BG002|Baseline|Total|Total of all reporting groups
10999390|NCT01050543|FG000|Participant Flow|Sugammadex|sugammadex 2 mg/kg
10999391|NCT01050543|FG001|Participant Flow|Neostigmine|neostigmine 50 mcg/kg
10999392|NCT01050543|OG000|Outcome|Sugammadex|sugammadex 2 mg/kg
10999393|NCT01050543|OG001|Outcome|Neostigmine|neostigmine 50 mcg/kg
10999394|NCT01050543|EG000|Reported Event|Sugammadex|sugammadex 2 mg/kg
10999395|NCT01050543|EG001|Reported Event|Neostigmine|neostigmine 50 mcg/kg
10999396|NCT01050569|BG000|Baseline|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
10999397|NCT01050569|BG001|Baseline|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
10999398|NCT01050569|BG002|Baseline|Nicotine Patch|21 mg nicotine patch
10999399|NCT01050569|BG003|Baseline|Total|Total of all reporting groups
11223977|NCT02357264|OG001|Outcome|Pregnant Females With Suspicion of Pre-eclampsia|Pregnant females who the OB/GYN physician has suspicion that may have pre-eclampsia
10999400|NCT01050569|FG000|Participant Flow|VLNC Cigarette|Very Low Nicotine Content Cigarette: Cigarette where the tobacco contains <0.1 mg of nicotine yield. Participants were asked to smoke experimental cigarettes in an ad lib basis. Product was used for 6 weeks.
10999401|NCT01050569|FG001|Participant Flow|VLNC Cigarette Plus Nicotine Patch|Very Low Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. Nicotine patch was administered on a daily basis. Participants were asked to use experimental cigarettes on an ad lib basis. Products were used for 6 weeks.
10999402|NCT01050569|FG002|Participant Flow|Nicotine Patch|Nicotine Patch: 21 mg. Nicotine patch was administered on a daily basis for a period of 6 weeks.
10999403|NCT01050569|OG000|Outcome|VLNC Cigarette|VLNC Cigarettes: Cigarette where the tobacco contains <0.1 mg nicotine yield.
10999404|NCT01050569|OG001|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
10999405|NCT01050569|OG002|Outcome|Nicotine Patch|21 mg nicotine patch
10999406|NCT01050569|OG000|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
10999407|NCT01050569|OG001|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
10999408|NCT01050569|OG001|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch : 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
10999409|NCT01050569|OG001|Outcome|VLNC Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
10999410|NCT01050569|EG000|Reported Event|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
10999411|NCT01050569|EG001|Reported Event|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
10999412|NCT01050569|EG002|Reported Event|Nicotine Patch|21 mg nicotine patch
10999413|NCT01050582|BG000|Baseline|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
10999414|NCT01050582|BG001|Baseline|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
10999415|NCT01050582|BG002|Baseline|Total|Total of all reporting groups
10999416|NCT01050582|FG000|Participant Flow|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
10999417|NCT01050582|FG001|Participant Flow|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
10999418|NCT01050582|OG000|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
10999419|NCT01050582|OG001|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
10999420|NCT01050582|EG000|Reported Event|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
10999421|NCT01050582|EG001|Reported Event|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
10999422|NCT01050634|BG000|Baseline|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
10999423|NCT01050634|FG000|Participant Flow|Aromasin (Exemestane)|The recommended dosage of exemestane was 25mg once a day.
10999424|NCT01050634|OG000|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
10999425|NCT01050634|EG000|Reported Event|Observational|
10999426|NCT01050647|BG000|Baseline|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
11223978|NCT02357264|EG000|Reported Event|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
10999427|NCT01050647|BG001|Baseline|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
10999428|NCT01050647|BG002|Baseline|Total|Total of all reporting groups
10999429|NCT01050647|FG000|Participant Flow|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
10999430|NCT01050647|FG001|Participant Flow|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
10999431|NCT01050647|OG000|Outcome|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
10999432|NCT01050647|OG001|Outcome|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
10999433|NCT01050647|EG000|Reported Event|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
10999434|NCT01050647|EG001|Reported Event|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
11223979|NCT02357264|EG001|Reported Event|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
10999435|NCT01050660|BG000|Baseline|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
10999436|NCT01050660|BG001|Baseline|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
10999437|NCT01050660|BG002|Baseline|Total|Total of all reporting groups
10999438|NCT01050660|FG000|Participant Flow|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
10999439|NCT01050660|FG001|Participant Flow|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
10999440|NCT01050660|OG000|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
10999441|NCT01050660|OG001|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
10999442|NCT01050660|EG000|Reported Event|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion: An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
10999443|NCT01050660|EG001|Reported Event|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d: Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
11007646|NCT01092195|FG000|Participant Flow|Transplant With Immunosuppression|Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007647|NCT01092195|FG001|Participant Flow|Transplant With no Immunosuppression|Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007648|NCT01092195|FG002|Participant Flow|Healthy Volunteer|Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007649|NCT01092195|OG000|Outcome|Transplant With Immunosuppression|Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007650|NCT01092195|OG001|Outcome|Transplant With no Immunosuppression|Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007651|NCT01092195|OG002|Outcome|Healthy Volunteer|Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007652|NCT01092195|EG000|Reported Event|Transplant With Immunosuppression|Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007653|NCT01092195|EG001|Reported Event|Transplant With no Immunosuppression|Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007654|NCT01092195|EG002|Reported Event|Healthy Volunteer|Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
11007655|NCT01092338|BG000|Baseline|4000IU/d of Vitamin D3|
11007656|NCT01092338|BG001|Baseline|7000IU/d Vitamin D3|
11007657|NCT01092338|BG002|Baseline|Total|Total of all reporting groups
11007658|NCT01092338|FG000|Participant Flow|4000IU/d of Vitamin D3|
11007659|NCT01092338|FG001|Participant Flow|7000IU/d Vitamin D3|
11007660|NCT01092338|OG000|Outcome|4000IU/d of Vitamin D3|
11007661|NCT01092338|OG001|Outcome|7000IU/d Vitamin D3|
11007662|NCT01092338|EG000|Reported Event|4000IU/d of Vitamin D3|
11007663|NCT01092338|EG001|Reported Event|7000IU/d Vitamin D3|
11007664|NCT01092364|BG000|Baseline|Cell Phone Intervention|"Behavioral lifestyle intervention for weight loss, delivered by cell phone.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
11007665|NCT01092364|BG001|Baseline|Personal Counseling Intervention|"Behavioral lifestyle intervention for weight loss, delivered by personal counseling.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
11007666|NCT01092364|BG002|Baseline|Advice Only|Advice only control group.
11007667|NCT01092364|BG003|Baseline|Total|Total of all reporting groups
11007668|NCT01092364|FG000|Participant Flow|Cell Phone Intervention|"Behavioral lifestyle intervention for weight loss, delivered by cell phone.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
11007669|NCT01092364|FG001|Participant Flow|Personal Counseling Intervention|"Behavioral lifestyle intervention for weight loss, delivered by personal counseling.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
11007670|NCT01092364|FG002|Participant Flow|Advice Only|Advice only control group.
11007671|NCT01092364|OG000|Outcome|Cell Phone Intervention|"Behavioral lifestyle intervention for weight loss, delivered by cell phone.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
10999444|NCT01050673|BG000|Baseline|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
10999445|NCT01050673|BG001|Baseline|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
10999446|NCT01050673|BG002|Baseline|Total|Total of all reporting groups
10999447|NCT01050673|FG000|Participant Flow|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
10999448|NCT01050673|FG001|Participant Flow|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
10999449|NCT01050673|OG000|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
10999450|NCT01050673|OG001|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
10999451|NCT01050673|EG000|Reported Event|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
10999452|NCT01050673|EG001|Reported Event|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
10999453|NCT01050764|BG000|Baseline|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
10999454|NCT01050764|FG000|Participant Flow|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
10999455|NCT01050764|OG000|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
10999456|NCT01050764|EG000|Reported Event|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
10999457|NCT01050790|BG000|Baseline|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
10999458|NCT01050790|FG000|Participant Flow|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
10999459|NCT01050790|OG000|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
10999460|NCT01050790|OG000|Outcome|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
10999461|NCT01050790|EG000|Reported Event|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
10999462|NCT01050816|BG000|Baseline|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
10999463|NCT01050816|FG000|Participant Flow|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
10999464|NCT01050816|OG000|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
10999465|NCT01050816|EG000|Reported Event|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
10999466|NCT01050907|BG000|Baseline|Miltefosine|Miltefosine: 2.5 mg/kg/day for 28 days
10845210|NCT00265616|BG001|Baseline|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
10999467|NCT01050907|FG000|Participant Flow|Miltefosine|Miltefosine: 2.5 mg/kg/day for 28 days
10999468|NCT01050907|OG000|Outcome|Miltefosine|Miltefosine: 2.5 mg/kg/day for 28 days
10999469|NCT01050907|EG000|Reported Event|Miltefosine|Miltefosine: 2.5 mg/kg/day for 28 days
11007672|NCT01092364|OG001|Outcome|Personal Counseling Intervention|"Behavioral lifestyle intervention for weight loss, delivered by personal counseling.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
11007673|NCT01092364|OG002|Outcome|Advice Only|Advice only control group.
10845211|NCT00265616|BG002|Baseline|Total|Total of all reporting groups
10845212|NCT00265616|FG000|Participant Flow|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG);no maximum doses defined.
10845213|NCT00265616|FG001|Participant Flow|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG); no maximum doses defined.
10845214|NCT00265616|OG000|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
10845215|NCT00265616|OG001|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
10845216|NCT00265616|EG000|Reported Event|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
10845217|NCT00265616|EG001|Reported Event|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
10845218|NCT00265759|BG000|Baseline|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10845219|NCT00265759|BG001|Baseline|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10845220|NCT00265759|BG002|Baseline|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10845221|NCT00265759|BG003|Baseline|Cohort B Arm I: Week 2 Ki67 <=10%|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
10845222|NCT00265759|BG004|Baseline|Cohort B Arm II: Week 2 Ki67 >10%|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
10845223|NCT00265759|BG005|Baseline|Cohort B Arm III: Week 2 Ki67 No Invasive Disease Present|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
10845224|NCT00265759|BG006|Baseline|Total|Total of all reporting groups
10845225|NCT00265759|FG000|Participant Flow|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
10845226|NCT00265759|FG001|Participant Flow|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
10845227|NCT00265759|FG002|Participant Flow|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
10845228|NCT00265759|FG003|Participant Flow|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
10845229|NCT00265759|OG000|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10845230|NCT00265759|OG001|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10845231|NCT00265759|OG002|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10845232|NCT00265759|OG000|Outcome|Cohort B Arm II: Week 2 Ki67 > 10%|Patients who after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy had a tumor Ki67 level of greater than 10% and switched to neoadjuvant chemotherapy.
10845233|NCT00265759|OG000|Outcome|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
10845234|NCT00265759|EG000|Reported Event|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10999470|NCT01050946|BG000|Baseline|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
10999471|NCT01050946|FG000|Participant Flow|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
10999472|NCT01050946|OG000|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.~Haploidentical/cord transplant: Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
10999473|NCT01050946|OG000|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
10999474|NCT01050946|EG000|Reported Event|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
10999475|NCT01050998|BG000|Baseline|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999476|NCT01050998|BG001|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999477|NCT01050998|BG002|Baseline|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999478|NCT01050998|BG003|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999479|NCT01050998|BG004|Baseline|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999480|NCT01050998|BG005|Baseline|Total|Total of all reporting groups
10999481|NCT01050998|FG000|Participant Flow|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999482|NCT01050998|FG001|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999483|NCT01050998|FG002|Participant Flow|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999484|NCT01050998|FG003|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999485|NCT01050998|FG004|Participant Flow|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999486|NCT01050998|OG000|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999487|NCT01050998|OG001|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999488|NCT01050998|OG002|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999489|NCT01050998|OG003|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
11223980|NCT02357290|BG000|Baseline|Open-Label Treatment With NAC|12-week, open-label treatment with NAC.
10999490|NCT01050998|OG004|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999491|NCT01050998|OG000|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999492|NCT01050998|OG001|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999493|NCT01050998|OG002|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999494|NCT01050998|OG003|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999495|NCT01050998|EG000|Reported Event|CAM-3001 10 MG|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999496|NCT01050998|EG001|Reported Event|CAM-3001 30 MG|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999497|NCT01050998|EG002|Reported Event|CAM-3001 50 MG|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999498|NCT01050998|EG003|Reported Event|CAM-3001 100 MG|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10845235|NCT00265759|EG001|Reported Event|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10999499|NCT01050998|EG004|Reported Event|PLACEBO|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
10999500|NCT01051063|BG000|Baseline|Complete Remission Group|Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
10999501|NCT01051063|BG001|Baseline|Partial Remission Group|Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
10999502|NCT01051063|BG002|Baseline|Total|Total of all reporting groups
10999503|NCT01051063|FG000|Participant Flow|Complete Remission Group|Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
10999504|NCT01051063|FG001|Participant Flow|Partial Remission Group|Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
10999505|NCT01051063|OG000|Outcome|Complete Remission Group|Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
11223981|NCT02357290|FG000|Participant Flow|Open-Label Treatment With NAC|12-week, open-label treatment with NAC.
10845236|NCT00265759|EG002|Reported Event|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
10845741|NCT00269477|BG000|Baseline|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
10999506|NCT01051063|OG001|Outcome|Partial Remission Group|Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
10999507|NCT01051063|OG000|Outcome|Total Treated Group|All adult patients (who underwent either partial or complete remission after induction chemotherapy) who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
11007674|NCT01092364|EG000|Reported Event|Cell Phone Intervention|"Behavioral lifestyle intervention for weight loss, delivered by cell phone.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
11223982|NCT02357290|OG000|Outcome|Open-Label Treatment With NAC|12-week, open-label treatment with NAC.
11223983|NCT02357290|EG000|Reported Event|Open-Label Treatment With NAC|12-week, open-label treatment with NAC.
10999508|NCT01051063|OG000|Outcome|Total Treated Group|All adult patients (Who underwent either partial or complete remission after induction chemotherapy) who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
10999509|NCT01051063|EG000|Reported Event|Total Treated Group|All adult patients (who underwent either partial or complete remission after induction chemotherapy) who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
10999510|NCT01051310|BG000|Baseline|Overall Study|All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
10999511|NCT01051310|FG000|Participant Flow|Overall Study|All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
10999512|NCT01051310|OG000|Outcome|Overall Study|All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
10999513|NCT01051310|EG000|Reported Event|Overall Study|All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
10999514|NCT01051323|BG000|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999515|NCT01051323|BG001|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999516|NCT01051323|BG002|Baseline|Total|Total of all reporting groups
10999517|NCT01051323|FG000|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999518|NCT01051323|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999519|NCT01051323|OG001|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999520|NCT01051323|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999521|NCT01051323|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999522|NCT01051323|EG000|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999523|NCT01051323|EG001|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
10999524|NCT01051349|BG000|Baseline|BIIB019|Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
10999525|NCT01051349|FG000|Participant Flow|BIIB019|Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
10999526|NCT01051349|OG000|Outcome|BIIB019|Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
10999527|NCT01051349|OG000|Outcome|BIIB019 (Prefilled Syringe [PFS])|Participants received BIIB019, 150 mg subcutaneous injection in a prefilled syringe every 4 weeks up to Week 276.
10999528|NCT01051349|OG001|Outcome|BIIB019 (Autoinjector [AI])|Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.
10999529|NCT01051349|OG000|Outcome|BIIB019 (Prefilled Syringe [PFS])|Participants received BIIB019, 150 mg subcutaneous injection in a prefilled syringe every 4 weeks up to Week 288.
10999530|NCT01051349|EG000|Reported Event|BIIB019|Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
10999531|NCT01051440|BG000|Baseline|Placebo|Subjects received matched placebo for lisdexamfetamine.
10999532|NCT01051440|BG001|Baseline|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
10999533|NCT01051440|BG002|Baseline|Total|Total of all reporting groups
10999534|NCT01051440|FG000|Participant Flow|Placebo|Subjects received matched placebo for lisdexamfetamine.
10999535|NCT01051440|FG001|Participant Flow|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
10999536|NCT01051440|OG000|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
10999537|NCT01051440|OG001|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
10999538|NCT01051440|EG000|Reported Event|Placebo|Subjects received matched placebo for lisdexamfetamine.
10999539|NCT01051440|EG001|Reported Event|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
10999540|NCT01051466|BG000|Baseline|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
10999541|NCT01051466|BG001|Baseline|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
10999542|NCT01051466|BG002|Baseline|Total|Total of all reporting groups
10999543|NCT01051466|FG000|Participant Flow|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
10999544|NCT01051466|FG001|Participant Flow|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
10999545|NCT01051466|OG000|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
10999546|NCT01051466|OG001|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
10999547|NCT01051466|OG001|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
10999548|NCT01051466|OG001|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom (UK) Edition (WAIS-III^UK). Healthy participants did not receive study drug.
10999549|NCT01051466|EG000|Reported Event|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD) received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose.
10999550|NCT01051466|EG001|Reported Event|Healthy Participants|Healthy participants: Participants were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
10999551|NCT01051518|BG000|Baseline|High Risk|Subjects with a high risk of operative mortality.
10999552|NCT01051518|BG001|Baseline|Moderate Risk|Subjects with a moderate risk of operative mortality.
10999553|NCT01051518|BG002|Baseline|Total|Total of all reporting groups
10999554|NCT01051518|FG000|Participant Flow|Overall Study|All enrolled subjects for whom the procedure of percutaneous implantation of the Medtronic CoreValve aortic valve prosthesis was started.
10999555|NCT01051518|OG000|Outcome|High Risk|Subjects with a high risk of operative mortality.
10999556|NCT01051518|OG001|Outcome|Moderate Risk|Subjects with a moderate risk of operative mortality.
10999557|NCT01051518|OG002|Outcome|Overall Study|All enrolled subjects for whom the procedure for percutaneous implantation of the Medtronic CoreValve aortic valve prosthesis was started.
10999558|NCT01051518|OG000|Outcome|High Risk With Complete Device Success Data|Subjects with a high risk of operative mortality with all data available to calculate the composite technical device success
10999559|NCT01051518|OG001|Outcome|Moderate Risk With Complete Device Success Data|Subjects with a moderate risk of operative mortality with all data available to calculate the composite technical device success
10999560|NCT01051518|EG000|Reported Event|High Risk|Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.
10999561|NCT01051518|EG001|Reported Event|Moderate Risk|Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.
11223984|NCT02357342|BG000|Baseline|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection"
10999562|NCT01051557|BG000|Baseline|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999563|NCT01051557|BG001|Baseline|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999564|NCT01051557|BG002|Baseline|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999565|NCT01051557|BG003|Baseline|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999566|NCT01051557|BG004|Baseline|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999567|NCT01051557|BG005|Baseline|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999568|NCT01051557|BG006|Baseline|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999569|NCT01051557|BG007|Baseline|Total|Total of all reporting groups
10999570|NCT01051557|FG000|Participant Flow|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
11223985|NCT02357342|BG001|Baseline|Standard of Care Intravitreal antiVEGF|"antiVEGF intravitreal injections~Standard of Care intravitreal injections of antiVEGF: intravitreal injections of antiVEGF"
11223986|NCT02357342|BG002|Baseline|Total|Total of all reporting groups
10999571|NCT01051557|FG001|Participant Flow|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999572|NCT01051557|FG002|Participant Flow|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999573|NCT01051557|FG003|Participant Flow|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999574|NCT01051557|FG004|Participant Flow|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999575|NCT01051557|FG005|Participant Flow|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
11223987|NCT02357342|FG000|Participant Flow|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
11223988|NCT02357342|FG001|Participant Flow|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
11223989|NCT02357342|OG000|Outcome|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
11336489|NCT03567005|FG000|Participant Flow|DACP Digital Then DACP|Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.
10999576|NCT01051557|FG006|Participant Flow|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999577|NCT01051557|OG000|Outcome|Treatment (Temsirolimus and Perifosine)|"PHASE I: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and perifosine PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive temsirolimus and perifosine as in phase I. Some patients may also undergo cytoreductive surgery."
10999578|NCT01051557|OG000|Outcome|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999579|NCT01051557|OG001|Outcome|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999580|NCT01051557|OG002|Outcome|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999581|NCT01051557|OG003|Outcome|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999582|NCT01051557|OG004|Outcome|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999583|NCT01051557|OG005|Outcome|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999584|NCT01051557|OG006|Outcome|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999585|NCT01051557|EG000|Reported Event|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
11223990|NCT02357342|OG001|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
11223991|NCT02357342|EG000|Reported Event|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
10999586|NCT01051557|EG001|Reported Event|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999587|NCT01051557|EG002|Reported Event|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999588|NCT01051557|EG003|Reported Event|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999589|NCT01051557|EG004|Reported Event|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999590|NCT01051557|EG005|Reported Event|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999591|NCT01051557|EG006|Reported Event|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
10999592|NCT01051570|BG000|Baseline|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
10999593|NCT01051570|FG000|Participant Flow|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
10999594|NCT01051570|OG000|Outcome|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
11223992|NCT02357342|EG001|Reported Event|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
10999595|NCT01051570|EG000|Reported Event|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
10999596|NCT01051596|BG000|Baseline|ABT-888 and Temozolomide|"Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle~Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle~ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle"
10999597|NCT01051596|FG000|Participant Flow|ABT-888 and Temozolomide|"Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle~Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle~ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle"
10999598|NCT01051596|OG000|Outcome|ABT-888 and Temozolomide|"Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle~Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle~ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle"
10999599|NCT01051596|EG000|Reported Event|ABT-888 and Temozolomide|"Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle~Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle~ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle"
10999600|NCT01051661|BG000|Baseline|Arepanrix 2D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999601|NCT01051661|BG001|Baseline|Arepanrix 2D 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999602|NCT01051661|BG002|Baseline|Arepanrix 1D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999603|NCT01051661|BG003|Baseline|Arepanrix 1D 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999604|NCT01051661|BG004|Baseline|GSK2340273A 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999605|NCT01051661|BG005|Baseline|GSK2340273A 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999606|NCT01051661|BG006|Baseline|Total|Total of all reporting groups
10999607|NCT01051661|FG000|Participant Flow|Arepanrix 2D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999608|NCT01051661|FG001|Participant Flow|Arepanrix 2D 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999609|NCT01051661|FG002|Participant Flow|Arepanrix 1D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999610|NCT01051661|FG003|Participant Flow|Arepanrix 1D 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999611|NCT01051661|FG004|Participant Flow|GSK2340273A 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999612|NCT01051661|FG005|Participant Flow|GSK2340273A 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
11007675|NCT01092364|EG001|Reported Event|Personal Counseling Intervention|"Behavioral lifestyle intervention for weight loss, delivered by personal counseling.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
10999613|NCT01051661|OG000|Outcome|Arepanrix 2D Group|Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
10999614|NCT01051661|OG001|Outcome|Arepanrix 1D Group|Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
10999615|NCT01051661|OG002|Outcome|GSK2340273A Group|Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
10999616|NCT01051661|OG000|Outcome|Arepanrix 2D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999617|NCT01051661|OG001|Outcome|Arepanrix 2D 3Y-6Y Group|Subjects, male and female, aged 3 years (Y) to less than (<) 6 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999618|NCT01051661|OG002|Outcome|Arepanrix 2D 6Y-10Y Group|Subjects, male and female, aged 6 years (Y) to less than (<) 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999619|NCT01051661|OG003|Outcome|Arepanrix 1D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999620|NCT01051661|OG004|Outcome|Arepanrix 1D 3Y-6Y Group|Subjects, male and female, aged 3 years (Y) to less than (<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999621|NCT01051661|OG005|Outcome|Arepanrix 1D 6Y-10Y Group|Subjects, male and female, aged 6 years (Y) to less than (<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10877789|NCT00449007|BG000|Baseline|Fluoxetine|"fluoxetine -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~fluoxetine: 6 months"
10999622|NCT01051661|OG006|Outcome|GSK2340273A 6M-3Y Group|Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999623|NCT01051661|OG007|Outcome|GSK2340273A 3Y-6Y Group|Subjects, male and female, aged 2 years (Y) to less than (<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999624|NCT01051661|OG008|Outcome|GSK2340273A 6Y-10Y Group|Subjects, male and female, aged 6 years (Y) to less than (<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999625|NCT01051661|OG002|Outcome|Arepanrix 1D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999626|NCT01051661|OG003|Outcome|Arepanrix 1D 3Y-6Y Group|Subjects, male and female, aged 3 years (Y) to less than (<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999627|NCT01051661|OG004|Outcome|GSK2340273A 6M-3Y Group|Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999628|NCT01051661|OG005|Outcome|GSK2340273A 3Y-6Y Group|Subjects, male and female, aged 2 years (Y) to less than (<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999629|NCT01051661|OG000|Outcome|Arepanrix 2D 6Y-10Y Group|Subjects, male and female, aged 6 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999630|NCT01051661|OG001|Outcome|Arepanrix 1D 6Y-10Y Group|Subjects, male and female, aged 6 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999631|NCT01051661|OG002|Outcome|GSK2340273A 6Y-10Y Group|Subjects, male and female, aged 6 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999632|NCT01051661|OG000|Outcome|Arepanrix 2D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999633|NCT01051661|OG001|Outcome|Arepanrix 2D 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999634|NCT01051661|OG002|Outcome|Arepanrix 1D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999635|NCT01051661|OG003|Outcome|Arepanrix 1D 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999636|NCT01051661|OG004|Outcome|GSK2340273A 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999637|NCT01051661|OG005|Outcome|GSK2340273A 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999638|NCT01051661|OG000|Outcome|Arepanrix 1D Group|Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
11007676|NCT01092364|EG002|Reported Event|Advice Only|Advice only control group.
11007677|NCT01092416|BG000|Baseline|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
11007678|NCT01092416|FG000|Participant Flow|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
11007679|NCT01092416|OG000|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
10846624|NCT00278564|BG000|Baseline|Hematopoietic Stem Cell Transplantation|"Intervention as hematopoietic stem cells transplantation after conditioning regimen: Autologous hematopoietic stem cells will be injected after conditioning regimen~Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation"
10999639|NCT01051661|OG001|Outcome|Arepanrix 2D Group|Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
10999640|NCT01051661|EG000|Reported Event|Arepanrix 2D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999641|NCT01051661|EG001|Reported Event|Arepanrix 2D 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999642|NCT01051661|EG002|Reported Event|Arepanrix 1D 6M-3Y Group|Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999643|NCT01051661|EG003|Reported Event|Arepanrix 1D 3Y-10Y Group|Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999644|NCT01051661|EG004|Reported Event|GSK2340273A 6M-3Y Group|Subjects, male and female, aged 6 months to 3 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children <12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children <12 months of age, in the right anterolateral thigh.
10999645|NCT01051661|EG005|Reported Event|GSK2340273A 3Y-10Y Group|Subjects, male and female, aged 3 years to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
10999646|NCT01051739|BG000|Baseline|Group 1|glaucoma with mean deviation from 0 to -25 dB
10999647|NCT01051739|BG001|Baseline|Group 2|normal - healthy observers with no eye pathology other than refractive error less than 6 diopters of correction.
10999648|NCT01051739|BG002|Baseline|Total|Total of all reporting groups
10999649|NCT01051739|FG000|Participant Flow|Group 1|glaucoma patients
10999650|NCT01051739|FG001|Participant Flow|Group 2|normal ocular healthy controls
10999651|NCT01051739|OG000|Outcome|Glaucoma|mean deviation 0 to -25 dB
10999652|NCT01051739|OG001|Outcome|Control|Age-matched healthy observers were tested at baseline and then every six months for 4 years
10999653|NCT01051739|EG000|Reported Event|Group 1|"glaucoma~Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
10999654|NCT01051739|EG001|Reported Event|Group 2|"normal~Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
10999655|NCT01051778|BG000|Baseline|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
10999656|NCT01051778|BG001|Baseline|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
10999657|NCT01051778|BG002|Baseline|Total|Total of all reporting groups
10999658|NCT01051778|FG000|Participant Flow|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
10999659|NCT01051778|FG001|Participant Flow|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
10999660|NCT01051778|OG000|Outcome|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
10845742|NCT00269477|BG001|Baseline|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
10999661|NCT01051778|OG001|Outcome|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
10999662|NCT01051778|EG000|Reported Event|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
10999663|NCT01051778|EG001|Reported Event|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
10999664|NCT01051791|BG000|Baseline|Everolimus 10 mg Daily|Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
10999665|NCT01051791|FG000|Participant Flow|Everolimus 10 mg Daily|Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
10999666|NCT01051791|OG000|Outcome|Everolimus 10 mg Daily|Patients that completed at least 1 cycle of everolimus everolimus 10 mg by mouth daily. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.
10999667|NCT01051791|OG000|Outcome|Everolimus 10 mg Daily|Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
10999668|NCT01051791|EG000|Reported Event|Everolimus 10 mg Daily|Patients with any treatment of everolimus 10 mg by mouth daily.
10999669|NCT01051817|BG000|Baseline|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
10999670|NCT01051817|BG001|Baseline|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
10999671|NCT01051817|BG002|Baseline|Total|Total of all reporting groups
10999672|NCT01051817|FG000|Participant Flow|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
10999673|NCT01051817|FG001|Participant Flow|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
10999674|NCT01051817|OG000|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
10999675|NCT01051817|OG001|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
10999676|NCT01051817|EG000|Reported Event|PLACEBO|PLACEBO
10999677|NCT01051817|EG001|Reported Event|AIN457 10mg/kg|AIN457 10mg/kg
10999678|NCT01051856|BG000|Baseline|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
10999679|NCT01051856|BG001|Baseline|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
10999680|NCT01051856|BG002|Baseline|Total|Total of all reporting groups
10999681|NCT01051856|FG000|Participant Flow|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
10999682|NCT01051856|FG001|Participant Flow|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
10999683|NCT01051856|OG000|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
10999684|NCT01051856|OG001|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
10999685|NCT01051856|EG000|Reported Event|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
10999686|NCT01051856|EG001|Reported Event|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
10999687|NCT01051960|BG000|Baseline|Ambrisentan|"ambrisentan dosed at either 5mg or 10mg orally once per day~Ambrisentan: Ambrisentan 5mg or 10mg once daily"
10999688|NCT01051960|FG000|Participant Flow|Ambrisentan|"ambrisentan dosed at either 5mg or 10mg orally once per day~Ambrisentan: Ambrisentan 5mg or 10mg once daily"
10999689|NCT01051960|OG000|Outcome|Ambrisentan|"ambrisentan dosed at either 5mg or 10mg orally once per day~Ambrisentan: Ambrisentan 5mg or 10mg once daily"
10999690|NCT01051960|EG000|Reported Event|Ambrisentan|"ambrisentan dosed at either 5mg or 10mg orally once per day~Ambrisentan: Ambrisentan 5mg or 10mg once daily"
10999691|NCT01051986|BG000|Baseline|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
10999692|NCT01051986|BG001|Baseline|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
10999693|NCT01051986|BG002|Baseline|Total|Total of all reporting groups
10999694|NCT01051986|FG000|Participant Flow|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
10999695|NCT01051986|FG001|Participant Flow|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
10999696|NCT01051986|OG000|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
10999697|NCT01051986|OG001|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
10999698|NCT01051986|EG000|Reported Event|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
10999699|NCT01051986|EG001|Reported Event|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
10999700|NCT01052012|BG000|Baseline|Cohort 1-POSIMIR|Open Laparotomy
10999701|NCT01052012|BG001|Baseline|Cohort 1-Bupivacaine HCl|Open Laparotomy
10999702|NCT01052012|BG002|Baseline|Cohort 2-POSIMIR|Laparoscopic Cholecystectomy
10999703|NCT01052012|BG003|Baseline|Cohort 2-Bupivacaine HCl|Laparoscopic Cholecystectomy
11223993|NCT02357368|BG000|Baseline|Depot Medroxyprogesterone Acetate (DMPA)|Participants receiving DMPA administered every 12 weeks at the standard dose of 150 mg intramuscular injection, beginning from Week 3 of study enrollment and repeated at Week 15
10999704|NCT01052012|BG004|Baseline|Cohort 3-POSIMIR|Laparoscopic Assisted Colectomy
10999705|NCT01052012|BG005|Baseline|Cohort 3-Placebo|Laparoscopic Assisted Colectomy
10999706|NCT01052012|BG006|Baseline|Total|Total of all reporting groups
10999707|NCT01052012|FG000|Participant Flow|Cohort 1-POSIMIR|Open Laparotomy
10999708|NCT01052012|FG001|Participant Flow|Cohort 1-Bupivacaine HCl|Open Laparotomy
10999709|NCT01052012|FG002|Participant Flow|Cohort 2-POSIMIR|Laparoscopic Cholecystectomy
10846625|NCT00278564|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|"Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen~Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation"
10999710|NCT01052012|FG003|Participant Flow|Cohort 2-Bupivacaine HCl|Laparoscopic Cholecystectomy
10999711|NCT01052012|FG004|Participant Flow|Cohort 3-POSIMIR|Laparoscopic Assisted Colectomy
10999712|NCT01052012|FG005|Participant Flow|Cohort 3-Placebo|Laparoscopic Assisted Colectomy
10999713|NCT01052012|OG000|Outcome|Cohort 1-POSIMIR|Open Laparotomy
10999714|NCT01052012|OG001|Outcome|Cohort 1-Bupivacaine HCl|Open Laparotomy
10999715|NCT01052012|OG002|Outcome|Cohort 2-POSIMIR|Laparoscopic Cholecystectomy
10999716|NCT01052012|OG003|Outcome|Cohort 2-Bupivacaine HCl|Laparoscopic Cholecystectomy
10999717|NCT01052012|OG004|Outcome|Cohort 3-POSIMIR|Laparoscopic Assisted Colectomy
10999718|NCT01052012|OG005|Outcome|Cohort 3-Placebo|Laparoscopic Assisted Colectomy
10999719|NCT01052012|EG000|Reported Event|Cohort 1-POSIMIR|Open Laparotomy
10999720|NCT01052012|EG001|Reported Event|Cohort 1-Bupivacaine HCl|Open Laparotomy
10999721|NCT01052012|EG002|Reported Event|Cohort 2-POSIMIR|Laparoscopic Cholecystectomy
10999722|NCT01052012|EG003|Reported Event|Cohort 2-Bupivacaine HCl|Laparoscopic Cholecystectomy
10999723|NCT01052012|EG004|Reported Event|Cohort 3-POSIMIR|Laparoscopic Assisted Colectomy
10999724|NCT01052012|EG005|Reported Event|Cohort 3-Placebo|Laparoscopic Assisted Colectomy
10999725|NCT01052038|BG000|Baseline|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
10999726|NCT01052038|BG001|Baseline|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
10999727|NCT01052038|BG002|Baseline|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
10999728|NCT01052038|BG003|Baseline|Total|Total of all reporting groups
10999729|NCT01052038|FG000|Participant Flow|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
10999730|NCT01052038|FG001|Participant Flow|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
10999731|NCT01052038|FG002|Participant Flow|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
10999732|NCT01052038|OG000|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
10999733|NCT01052038|OG001|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
10999734|NCT01052038|OG002|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
10999735|NCT01052038|EG000|Reported Event|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
10999736|NCT01052038|EG001|Reported Event|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
10999737|NCT01052038|EG002|Reported Event|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
10999738|NCT01052077|BG000|Baseline|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
10999739|NCT01052077|BG001|Baseline|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
11223994|NCT02357368|BG001|Baseline|Etonogestrel Impant (Eng-Implant)|Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
10999740|NCT01052077|BG002|Baseline|Total|Total of all reporting groups
10999741|NCT01052077|FG000|Participant Flow|Phase A|Participants entered a single-blind prospective treatment phase during which they received single-blind placebo plus open-label commercially available ADT for 8 weeks at maximally tolerated doses.
10999742|NCT01052077|FG001|Participant Flow|Brexiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
10999743|NCT01052077|FG002|Participant Flow|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
10999744|NCT01052077|FG003|Participant Flow|Phase A+|Participants who met the criteria for a response at the end of the 8 weeks prospective treatment phase received single-blind placebo + ADT for an additional 6 weeks in Phase A+ for a total of 14 weeks.
10999745|NCT01052077|OG000|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
10999746|NCT01052077|OG001|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
10999747|NCT01052077|EG000|Reported Event|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
10999748|NCT01052077|EG001|Reported Event|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
10999749|NCT01052103|BG000|Baseline|LY2140023 + SOC|1 week placebo lead-in period followed by 20 milligrams (mg) LY2140023 orally, twice daily for 16 weeks (40 mg/day) treatment period. The dose was allowed to adjust to a minimum of 20 mg/day or a maximum of 80 mg/day plus one of the following Standard of Care (SOC) Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling).
10999750|NCT01052103|BG001|Baseline|Placebo + SOC|1 week placebo lead-in period followed by placebo orally, twice daily for 16 weeks (40 mg/day) plus one of the following SOC Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling) during the treatment period.
10999751|NCT01052103|BG002|Baseline|Total|Total of all reporting groups
10999752|NCT01052103|FG000|Participant Flow|LY2140023 + SOC|1 week placebo lead-in period followed by 20 milligrams (mg) LY2140023 orally, twice daily for 16 weeks (40 mg/day) treatment period. The dose was allowed to adjust to a minimum of 20 mg/day or a maximum of 80 mg/day plus one of the following Standard of Care (SOC) Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling).
10999753|NCT01052103|FG001|Participant Flow|Placebo + SOC|1 week placebo lead-in period followed by placebo orally, twice daily for 16 weeks (40 mg/day) plus one of the following SOC Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling) during the treatment period.
10999754|NCT01052103|OG000|Outcome|LY2140023 + SOC|1 week placebo lead-in period followed by 20 milligrams (mg) LY2140023 orally, twice daily for 16 weeks (40 mg/day) treatment period. The dose was allowed to adjust to a minimum of 20 mg/day or a maximum of 80 mg/day plus one of the following Standard of Care (SOC) Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling).
10999755|NCT01052103|OG001|Outcome|Placebo + SOC|1 week placebo lead-in period followed by placebo orally, twice daily for 16 weeks (40 mg/day) plus one of the following SOC Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling) during the treatment period.
10999756|NCT01052103|OG000|Outcome|LY2140023 + SOC|1 week placebo lead-in period followed by 20 milligrams (mg) LY2140023, orally, twice daily for 16 weeks (40 mg/day) treatment period. The dose was allowed to adjust to a minimum of 20 mg/day or a maximum of 80 mg/day plus one of the following Standard of Care (SOC) Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling).
10999757|NCT01052103|EG000|Reported Event|LY2140023 + SOC|1 week placebo lead-in period followed by 20 milligrams (mg) LY2140023 orally, twice daily for 16 weeks (40 mg/day) treatment period. The dose was allowed to adjust to a minimum of 20 mg/day or a maximum of 80 mg/day plus one of the following Standard of Care (SOC) Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling).
10999758|NCT01052103|EG001|Reported Event|Placebo + SOC|1 week placebo lead-in period followed by placebo orally, twice daily for 16 weeks (40 mg/day) plus one of the following SOC Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling) during the treatment period.
10999759|NCT01052116|BG000|Baseline|Placebo|"Matching placebo~Tablet twice a day"
10999760|NCT01052116|BG001|Baseline|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
10999761|NCT01052116|BG002|Baseline|Total|Total of all reporting groups
10999762|NCT01052116|FG000|Participant Flow|Placebo|Matching placebo
10999763|NCT01052116|FG001|Participant Flow|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
10999764|NCT01052116|OG000|Outcome|Soy Isoflavone|"Oral soy isoflavone supplement~tablet twice daily (100 mg/day)"
10999765|NCT01052116|OG001|Outcome|Placebo|"Matching placebo~Tablet twice daily"
10999766|NCT01052116|EG000|Reported Event|Placebo|"Matching placebo~Tablet twice a day"
10999767|NCT01052116|EG001|Reported Event|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
10999768|NCT01052207|BG000|Baseline|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
10999769|NCT01052207|BG001|Baseline|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
10999770|NCT01052207|BG002|Baseline|Total|Total of all reporting groups
10999771|NCT01052207|FG000|Participant Flow|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
10999772|NCT01052207|FG001|Participant Flow|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
11007680|NCT01092416|OG000|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
10999773|NCT01052207|OG000|Outcome|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
10999774|NCT01052207|OG001|Outcome|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
10999775|NCT01052207|EG000|Reported Event|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected. only if deemed part of their clinical care"
10999776|NCT01052207|EG001|Reported Event|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
10999777|NCT01052272|BG000|Baseline|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
10999778|NCT01052272|BG001|Baseline|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
10999779|NCT01052272|BG002|Baseline|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
10999780|NCT01052272|BG003|Baseline|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
10999781|NCT01052272|BG004|Baseline|Total|Total of all reporting groups
10999782|NCT01052272|FG000|Participant Flow|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
10999783|NCT01052272|FG001|Participant Flow|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
10999784|NCT01052272|FG002|Participant Flow|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
10999785|NCT01052272|FG003|Participant Flow|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
10999786|NCT01052272|OG000|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
10999787|NCT01052272|OG001|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
10999788|NCT01052272|OG002|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
11007681|NCT01092416|OG000|Outcome|OAS Treatment Group|Subjects enrolled in ORBIT II study and in whom the atherectomy device was inserted.
11007682|NCT01092416|EG000|Reported Event|ORBIT II Subjects - 30 Day Results|Serious Adverse Events reported out to 30 Days Post-Procedure for Subjects enrolled in ORBIT II study.
10999789|NCT01052272|OG003|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
10999790|NCT01052272|EG000|Reported Event|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
10999791|NCT01052272|EG001|Reported Event|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
10999792|NCT01052272|EG002|Reported Event|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
10999793|NCT01052272|EG003|Reported Event|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
10999794|NCT01052428|BG000|Baseline|Placebo|
10999795|NCT01052428|BG001|Baseline|Toprol-XL|
10999796|NCT01052428|BG002|Baseline|Total|Total of all reporting groups
10999797|NCT01052428|FG000|Participant Flow|Placebo|
10845743|NCT00269477|BG002|Baseline|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
10999798|NCT01052428|FG001|Participant Flow|Toprol-XL|
10999799|NCT01052428|OG000|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
10999800|NCT01052428|OG001|Outcome|Toprol XL|Generic name metoprolol succinate
10999801|NCT01052428|EG000|Reported Event|Placebo|
10999802|NCT01052428|EG001|Reported Event|Toprol-XL|
10999803|NCT01052480|BG000|Baseline|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
10999804|NCT01052480|BG001|Baseline|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
10999805|NCT01052480|BG002|Baseline|Total|Total of all reporting groups
10999806|NCT01052480|FG000|Participant Flow|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
10999807|NCT01052480|FG001|Participant Flow|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
10999808|NCT01052480|OG000|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
10999809|NCT01052480|OG001|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
10999810|NCT01052480|EG000|Reported Event|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
10999811|NCT01052480|EG001|Reported Event|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
10999812|NCT01052493|BG000|Baseline|All Participant|Crossover, sequential study with all participant
10999813|NCT01052493|FG000|Participant Flow|Placebo, 4mg PP 1420, 8mg PP 1420|Intervention Period 1: Placebo Intervention period 2: 4mg PP 1420 Intervention period 3: 8mg PP 1420
10999814|NCT01052493|FG001|Participant Flow|2mg PP 1420, Placebo, 8mg PP 1420|Intervention Period 1: 2mg PP 1420 Intervention Period 2. Placebo Intervention Period 3. 8mg PP 1420
10999815|NCT01052493|FG002|Participant Flow|2mg PP 1420, 4mg PP 1420, Placebo|Intervention Period 1: 2mg PP 1420 Intervention Period 2. 4mg PP 1420 Intervention Period 3. Placebo
10999816|NCT01052493|OG000|Outcome|2mg PP 1420|Single dose of PP 1420, administered subcutaneously
10999817|NCT01052493|OG001|Outcome|4mg PP 1420|Single dose of PP 1420, administered subcutaneously
10999818|NCT01052493|OG002|Outcome|8mg PP 1420|Single dose of PP 1420, administered subcutaneously
10999819|NCT01052493|OG003|Outcome|Placebo|0.9% saline
10999820|NCT01052493|OG000|Outcome|2mg PP 1420|Single dose of PP 1420, administered subcutaneously.
10999821|NCT01052493|OG001|Outcome|4mg PP 1420|Single dose of PP 1420, administered subcutaneously.
10999822|NCT01052493|OG002|Outcome|8mg PP 1420|Single dose of PP 1420, administered subcutaneously.
10999823|NCT01052493|EG000|Reported Event|2mg PP 1420|Single dose of PP 1420, administered subcutaneously.
10999824|NCT01052493|EG001|Reported Event|4mg PP 1420|Single dose of PP 1420, administered subcutaneously.
10999825|NCT01052493|EG002|Reported Event|8mg PP 1420|Single dose of PP 1420, administered subcutaneously.
10999826|NCT01052493|EG003|Reported Event|Placebo|0.9% saline
10999827|NCT01052545|BG000|Baseline|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
10999828|NCT01052545|BG001|Baseline|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
10999829|NCT01052545|BG002|Baseline|Total|Total of all reporting groups
10999830|NCT01052545|FG000|Participant Flow|Arm 1- Intervention: Audit-Feedback|"Year 1: baseline surveillance at both sites Year 2: case based, individual audit and feedback delivered to providers, a guidelines based diagnostic algorithm for CAUTI versus asymptomatic bacteriuria (ASB) was given to providers and reinforced in the audit and feedback sessions.~Year 3: cased based, group audit and feedback delivered to providers, again based on this diagnostic algorithm.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
10999831|NCT01052545|FG001|Participant Flow|Arm 2- Control|This was the contemporary control group. Surveillance for the outcomes of interest (urine cultures order and antibiotics used to treat urine cultures) continued for all 3 years. Providers at this site received standard education about the CAUTI and asymptomatic bacteriuria guidelines delivered in a grand rounds format, and they also received a PDF of the full guidelines by email.
10999832|NCT01052545|OG000|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
10999833|NCT01052545|OG001|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
10999834|NCT01052545|OG000|Outcome|Intervention Group|Medicine and extended care wards at the intervention site
10999835|NCT01052545|OG001|Outcome|Control Group|Medicine and extended care wards at control site
10999836|NCT01052545|OG000|Outcome|Arm 1|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
10999837|NCT01052545|OG001|Outcome|Arm 2|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
10999838|NCT01052545|OG000|Outcome|Pre-Intervention Group|Medicine and extended care wards at the intervention site
10999839|NCT01052545|OG001|Outcome|Control Group- Post-Intervention|Medicine and extended care wards at control site
10999840|NCT01052545|OG002|Outcome|Post-intervention Group|Medicine and extended care wards at the intervention site
10999841|NCT01052545|OG001|Outcome|Control Group - Postintervention|Medicine and extended care wards at control site
10999842|NCT01052545|OG000|Outcome|Preintervention Acute Medical Care Line|Patients in acute medical care wards during the preintervention period
10999843|NCT01052545|OG001|Outcome|Preintervention Extended Care Line|Patients in the extended care (nursing home) wards during the preintervention period
10846626|NCT00278564|OG000|Outcome|Hematopoietic Stem Cell Transplantation|"Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen~Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation"
10999844|NCT01052545|OG000|Outcome|Intervention Group|Cases of positive urine cultures on medicine and extended care wards at the intervention site
10999845|NCT01052545|OG001|Outcome|Control Group|Cases of positive urine cultures on medicine and extended care wards at the control site
10999846|NCT01052545|EG000|Reported Event|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
10999847|NCT01052545|EG001|Reported Event|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
10999848|NCT01052662|BG000|Baseline|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
10999849|NCT01052662|BG001|Baseline|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
10999850|NCT01052662|BG002|Baseline|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
10999851|NCT01052662|BG003|Baseline|Total|Total of all reporting groups
10999852|NCT01052662|FG000|Participant Flow|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
10999853|NCT01052662|FG001|Participant Flow|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
10999854|NCT01052662|FG002|Participant Flow|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
10999855|NCT01052662|OG000|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
10999856|NCT01052662|OG001|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
11007683|NCT01092416|EG001|Reported Event|ORBIT II Subjects - 1 Year Results|Serious Adverse Events reported from 31 Days to 1 Year Post-Procedure for Subjects enrolled in ORBIT II study.
11007684|NCT01092442|BG000|Baseline|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
11223995|NCT02357368|BG002|Baseline|Levonorgestrel Intrauterine Device (Lng-IUD)|Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
11223996|NCT02357368|BG003|Baseline|ParaGard® T 380A Intrauterine Copper Contraceptive|Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
11223997|NCT02357368|BG004|Baseline|Total|Total of all reporting groups
10999857|NCT01052662|OG002|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
10999858|NCT01052662|EG000|Reported Event|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
10999859|NCT01052662|EG001|Reported Event|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
10999860|NCT01052662|EG002|Reported Event|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
10999861|NCT01052701|BG000|Baseline|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
10999862|NCT01052701|BG001|Baseline|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
10999863|NCT01052701|BG002|Baseline|Total|Total of all reporting groups
10999864|NCT01052701|FG000|Participant Flow|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
10999865|NCT01052701|FG001|Participant Flow|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
10999866|NCT01052701|OG000|Outcome|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
10999867|NCT01052701|OG001|Outcome|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
10999868|NCT01052701|EG000|Reported Event|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
10999869|NCT01052701|EG001|Reported Event|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
10999870|NCT01052714|BG000|Baseline|Usual Care|"Control group with time-matched study visits~Includes 17 participants who would later join Usual Care then Lifestyle Balance group to receive the Lifestyle Balance intervention."
10999871|NCT01052714|BG001|Baseline|Lifestyle Balance|"Weight management group education and individual counseling~Lifestyle Balance: Patients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition"
10999872|NCT01052714|BG002|Baseline|Total|Total of all reporting groups
10999873|NCT01052714|FG000|Participant Flow|Usual Care|Control group with time-matched study visits
10999874|NCT01052714|FG001|Participant Flow|Lifestyle Balance|"Weight management group education and individual counseling~Patients randomized to the Lifestyle Balance Program will do the following:~Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
10999875|NCT01052714|FG002|Participant Flow|Usual Care Then Lifestyle Balance|"Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.~Patients randomized to the Lifestyle Balance Program will do the following:~Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
10999876|NCT01052714|OG000|Outcome|Usual Care|Control group with time-matched study visits.
10999877|NCT01052714|OG001|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
10999878|NCT01052714|EG000|Reported Event|Usual Care|Control group with time-matched study visits
10999879|NCT01052714|EG001|Reported Event|Lifestyle Balance|"Weight management group education and individual counseling~Lifestyle Balance: Patients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition"
10999880|NCT01052779|BG000|Baseline|Ferumoxytol|Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
10999881|NCT01052779|BG001|Baseline|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
10999882|NCT01052779|BG002|Baseline|Total|Total of all reporting groups
10999883|NCT01052779|FG000|Participant Flow|Ferumoxytol|Participants received an intravenous (IV) injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).
10999884|NCT01052779|FG001|Participant Flow|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
10999885|NCT01052779|OG000|Outcome|Ferumoxytol|Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
10999886|NCT01052779|OG001|Outcome|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
10999887|NCT01052779|EG000|Reported Event|Ferumoxytol|Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
10999888|NCT01052779|EG001|Reported Event|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
10999889|NCT01052831|BG000|Baseline|Naltrexone|"Participants will receive Naltrexone~Naltrexone: 50-100 mg qd for 8 weeks"
10999890|NCT01052831|BG001|Baseline|Placebo|"Participants will receive placebo treatment~Placebo: 50-100 mg qd for 8 weeks"
10999891|NCT01052831|BG002|Baseline|Total|Total of all reporting groups
10999892|NCT01052831|FG000|Participant Flow|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
10999893|NCT01052831|FG001|Participant Flow|Placebo|Participants received the placebo treatment which looked identical to active study medication.
10999894|NCT01052831|OG000|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
10999895|NCT01052831|OG001|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
10999896|NCT01052831|EG000|Reported Event|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
10999897|NCT01052831|EG001|Reported Event|Placebo|Participants received the placebo treatment which looked identical to active study medication.
10999898|NCT01052844|BG000|Baseline|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
11007685|NCT01092442|BG001|Baseline|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
11007686|NCT01092442|BG002|Baseline|Total|Total of all reporting groups
10999899|NCT01052844|BG001|Baseline|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
10999900|NCT01052844|BG002|Baseline|Total|Total of all reporting groups
10999901|NCT01052844|FG000|Participant Flow|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
10999902|NCT01052844|FG001|Participant Flow|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
10999903|NCT01052844|OG000|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
10999904|NCT01052844|OG001|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
10999905|NCT01052844|EG000|Reported Event|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
10999906|NCT01052844|EG001|Reported Event|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
10999907|NCT01052948|BG000|Baseline|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
10999908|NCT01052948|BG001|Baseline|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
10999909|NCT01052948|BG002|Baseline|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
10999910|NCT01052948|BG003|Baseline|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
10999911|NCT01052948|BG004|Baseline|Total|Total of all reporting groups
10999912|NCT01052948|FG000|Participant Flow|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
10999913|NCT01052948|FG001|Participant Flow|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
10999914|NCT01052948|FG002|Participant Flow|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
10999915|NCT01052948|FG003|Participant Flow|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
10999916|NCT01052948|OG000|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
11223998|NCT02357368|FG000|Participant Flow|Depot Medroxyprogesterone Acetate (DMPA)|Participants receiving depot medroxyprogesterone acetate (DMPA) administered every 12 weeks at the standard dose of 150 mg intramuscular injection, beginning from Week 3 of study enrollment and repeated at Week 15
10999917|NCT01052948|OG001|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
10999918|NCT01052948|OG002|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
10999919|NCT01052948|OG003|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
10999920|NCT01052948|EG000|Reported Event|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
10999921|NCT01052948|EG001|Reported Event|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
10999922|NCT01052948|EG002|Reported Event|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
10999923|NCT01052948|EG003|Reported Event|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
10999924|NCT01053000|BG000|Baseline|All Study Participants|"Tazorac o.1% gel foer 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
10999925|NCT01053000|FG000|Participant Flow|Left Arm Tazorac/Right Arm No Tazorac Pre-treatment|Tazorac 0.1% gel was applied for 1 week to the left arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
10999926|NCT01053000|FG001|Participant Flow|Right Arm Tazorac/Left Arm No Pretreatment|Tazorac 0.1% gel was applied for 1 week to the right arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
10999927|NCT01053000|OG000|Outcome|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
10999928|NCT01053000|OG001|Outcome|No Pretreatment With Tzorac|"No pretreatmnet to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
10999929|NCT01053000|EG000|Reported Event|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
10999930|NCT01053000|EG001|Reported Event|No Pretreatment Arm|"No Pretreatment to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
10999931|NCT01053013|BG000|Baseline|Pancreatic Cancer|"Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.~RENCA Macrobeads."
10999932|NCT01053013|BG001|Baseline|Metastatic Colorectal Cancer|"Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.~RENCA macrobeads"
10999933|NCT01053013|BG002|Baseline|Total|Total of all reporting groups
10999934|NCT01053013|FG000|Participant Flow|Pancreatic Cancer|"Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.~RENCA Macrobeads."
10999935|NCT01053013|FG001|Participant Flow|Metastatic Colorectal Cancer|"Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.~RENCA macrobeads"
10999936|NCT01053013|OG000|Outcome|Pancreatic Cancer|"Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.~RENCA Macrobeads."
10999937|NCT01053013|OG001|Outcome|Metastatic Colorectal Cancer|"Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.~RENCA macrobeads"
10999938|NCT01053013|OG000|Outcome|Stable|mCRC participants with stable disease based on imaging results [Tumor measurements/SUV max].
10999939|NCT01053013|OG001|Outcome|Decreased/Necrosis|mCRC participants with decreased/necrosis observed based on imaging results [Tumor measurements/SUV max].
10999940|NCT01053013|OG002|Outcome|Increased|mCRC participants with increased SUVmax, tumor measurement based on imaging results.
10999941|NCT01053013|OG000|Outcome|mCRC: CEA Only|Participants with mCRC whose tumor marker response was greater than or equal to 20% decrease from baseline in CEA only [up to and including day 90 after the first implant).
10999942|NCT01053013|OG001|Outcome|mCRC CA 19-9 Only|Participants with mCRC whose tumor marker response was greater than or equal to 20% decrease from baseline in CA 19-9 only [up to and including day 90 after the first implant).
10999943|NCT01053013|OG002|Outcome|mCRC: Both CEA and CA 19-9|Participants with mCRC whose tumor marker response was greater than or equal to 20% decrease from baseline in both CEA and CA 19-9 [up to and including day 90 after the first implant).
10999944|NCT01053013|OG003|Outcome|mCRC: Non-responder|Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.
10999945|NCT01053013|OG000|Outcome|Pancreatic Cancer: CEA Only|Participants with pancreatic cancer whose tumor marker response was greater than or equal to 20% decrease from baseline in CEA only [up to and including day 90 after the first implant).
10999946|NCT01053013|OG001|Outcome|Pancreatic Cancer: CA 19-9 Only|Participants with pancreatic cancer whose tumor marker response was greater than or equal to 20% decrease from baseline in CA 19-9 only [up to and including day 90 after the first implant).
10999947|NCT01053013|OG002|Outcome|Pancreatic Cancer: Both CEA and CA 19-9|Participants with pancreatic cancer whose tumor marker response was greater than or equal to 20% decrease from baseline in both CEA and CA 19-9 [up to and including day 90 after the first implant).
10999948|NCT01053013|OG003|Outcome|Pancreatic Cancer: Non-responder|Participants with pancreatic cancer whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.
10999949|NCT01053013|OG000|Outcome|Implant 1: Day 0|CRP levels at baseline, prior to first implantation.
10999950|NCT01053013|OG001|Outcome|Implant 1: Day 14|CRP levels at day 14 after first implantation.
10999951|NCT01053013|OG002|Outcome|Implant 1: Day 30|CRP levels at day 30 after first implantation.
10999952|NCT01053013|OG003|Outcome|Implant 1: Day 60|CRP levels at day 60 after first implantation.
10999953|NCT01053013|OG004|Outcome|Implant 2: Day 0|CRP levels at day 0 of second implantation (day 90 following first implantation).
10999954|NCT01053013|OG005|Outcome|Implant 2: Day 14|CRP levels at day 14 after second implantation.
10999955|NCT01053013|OG006|Outcome|Implant 2: Day 30|CRP levels at day 30 after second implantation.
10999956|NCT01053013|OG007|Outcome|Implant 2: Day 60|CRP levels at day 60 after second implantation.
10999957|NCT01053013|OG000|Outcome|Implant 1: Day 0|ESR at baseline, prior to first implantation.
10999958|NCT01053013|OG001|Outcome|Implant 1: Day 14|ESR at day 14 after first implantation.
10999959|NCT01053013|OG002|Outcome|Implant 1: Day 30|ESR at day 30 after first implantation.
10999960|NCT01053013|OG003|Outcome|Implant 1: Day 60|ESR at day 60 after first implantation.
10999961|NCT01053013|OG004|Outcome|Implant 2: Day 0|ESR at day 0 of second implantation (day 90 following first implantation).
10999962|NCT01053013|OG005|Outcome|Implant 2: Day 14|ESR at day 14 after second implantation.
10999963|NCT01053013|OG006|Outcome|Implant 2: Day 30|ESR at day 30 after second implantation.
10999964|NCT01053013|OG007|Outcome|Implant 2: Day 60|ESR at day 60 after second implantation.
10999965|NCT01053013|OG000|Outcome|Implant 1: Day 0|CA 125 levels at baseline, prior to first implantation.
10999966|NCT01053013|OG001|Outcome|Implant 1: Day 14|CA 125 levels at day 14 after first implantation.
10999967|NCT01053013|OG002|Outcome|Implant 1: Day 30|CA 125 levels at day 30 after first implantation.
10999968|NCT01053013|OG003|Outcome|Implant 1: Day 60|CA 125 levels at day 60 after first implantation.
10999969|NCT01053013|OG004|Outcome|Implant 2: Day 0|CA 125 levels at day 0 of second implantation (day 90 following first implantation).
10999970|NCT01053013|OG005|Outcome|Implant 2: Day 14|CA 125 levels at day 14 after second implantation.
11223999|NCT02357368|FG001|Participant Flow|Etonogestrel Impant (Eng-Implant)|Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
10999971|NCT01053013|OG006|Outcome|Implant 2: Day 30|CA 125 levels at day 30 after second implantation.
10999972|NCT01053013|OG007|Outcome|Implant 2: Day 60|CA 125 levels at day 60 after second implantation.
10999973|NCT01053013|OG000|Outcome|Implant 1: Day 0|ECOG score at pre-screening for first implantation.
10999974|NCT01053013|OG001|Outcome|Implant 1: Day 14|ECOG score at day 14 after first implantation.
10999975|NCT01053013|OG002|Outcome|Implant 1: Day 30|ECOG score at day 30 after first implantation.
10999976|NCT01053013|OG003|Outcome|Implant 1: Day 60|ECOG score at day 60 after first implantation.
10999977|NCT01053013|OG004|Outcome|Implant 2: Day 0|ECOG score at pre-screening for second implantation (day 90 following first implantation).
10999978|NCT01053013|OG005|Outcome|Implant 2: Day 14|ECOG score at day 14 after second implantation.
10999979|NCT01053013|OG006|Outcome|Implant 2: Day 30|ECOG score at day 30 after second implantation.
10999980|NCT01053013|OG007|Outcome|Implant 2: Day 60|ECOG score at day 60 after second implantation.
10999981|NCT01053013|OG000|Outcome|Implant 1: Day 0|KPS score at pre-screening for first implantation.
10999982|NCT01053013|OG001|Outcome|Implant 1: Day 14|KPS score at day 14 after first implantation.
10999983|NCT01053013|OG002|Outcome|Implant 1: Day 30|KPS score at day 30 after first implantation.
10999984|NCT01053013|OG003|Outcome|Implant 1: Day 60|KPS score at day 60 after first implantation.
10999985|NCT01053013|OG004|Outcome|Implant 2: Day 0|KPS score at pre-screening for second implantation (day 90 following first implantation).
10999986|NCT01053013|OG005|Outcome|Implant 2: Day 14|KPS score at day 14 after second implantation.
10999987|NCT01053013|OG006|Outcome|Implant 2: Day 30|KPS score at day 30 after second implantation.
10999988|NCT01053013|OG007|Outcome|Implant 2: Day 60|KPS score at day 60 after second implantation.
10999989|NCT01053013|OG000|Outcome|Implant 1: Day 0|Global health status score at pre-screening for first implantation.
10999990|NCT01053013|OG001|Outcome|Implant 1: Day 14|Global health status score at day 14 after first implantation.
10999991|NCT01053013|OG002|Outcome|Implant 1: Day 30|Global health status score at day 30 after first implantation.
10999992|NCT01053013|OG003|Outcome|Implant 1: Day 60|Global health status score at day 60 after first implantation.
10999993|NCT01053013|OG004|Outcome|Implant 2: Day 0|Global health status score at pre-screening for second implantation (day 90 following first implantation).
10999994|NCT01053013|OG005|Outcome|Implant 2: Day 14|Global health status score at day 14 after second implantation.
10999995|NCT01053013|OG006|Outcome|Implant 2: Day 30|Global health status score at day 30 after second implantation.
10999996|NCT01053013|OG007|Outcome|Implant 2: Day 60|Global health status score at day 60 after second implantation.
10999997|NCT01053013|OG000|Outcome|Implant 1: Day 0|EORTC/Physical functioning score at pre-screening for first implantation.
10999998|NCT01053013|OG001|Outcome|Implant 1: Day 30|EORTC/Physical functioning score at day 30 after first implantation.
10999999|NCT01053013|OG002|Outcome|Implant 1: Day 60|EORTC/Physical functioning score at day 60 after first implantation.
11000000|NCT01053013|OG003|Outcome|Implant 2: Day 0|EORTC/Physical functioning score at pre-screening for second implantation (day 90 following first implantation).
11000001|NCT01053013|OG004|Outcome|Implant 2: Day 30|EORTC/Physical functioning score at day 30 after second implantation.
11000002|NCT01053013|OG005|Outcome|Implant 2: Day 60|EORTC/Physical functioning score at day 60 after second implantation.
11000003|NCT01053013|OG000|Outcome|Implant 1: Day 0|EORTC/Role functioning score at pre-screening for first implantation.
11000004|NCT01053013|OG001|Outcome|Implant 1: Day 30|EORTC/Role functioning score at day 30 after first implantation.
11000005|NCT01053013|OG002|Outcome|Implant 1: Day 60|EORTC/Role functioning score at day 60 after first implantation.
11000006|NCT01053013|OG003|Outcome|Implant 2: Day 0|EORTC/Role functioning score at pre-screening for second implantation (day 90 following first implantation).
11000007|NCT01053013|OG004|Outcome|Implant 2: Day 30|EORTC/Role functioning score at day 30 after second implantation.
11000008|NCT01053013|OG005|Outcome|Implant 2: Day 60|EORTC/Role functioning score at day 60 after second implantation.
11000009|NCT01053013|OG000|Outcome|Implant 1: Day 0|EORTC/Emotional functioning score at pre-screening for first implantation.
11000010|NCT01053013|OG001|Outcome|Implant 1: Day 30|EORTC/Emotional functioning score at day 30 after first implantation.
11000011|NCT01053013|OG003|Outcome|Implant 2: Day 0|EORTC/Emotional functioning score at pre-screening for second implantation (day 90 following first implantation).
11000012|NCT01053013|OG004|Outcome|Implant 2: Day 30|EORTC/Emotional functioning score at day 30 after second implantation.
11000013|NCT01053013|OG005|Outcome|Implant 2: Day 60|EORTC/Emotional functioning score at day 60 after second implantation.
11000014|NCT01053013|OG000|Outcome|Implant 1: Day 0|EORTC/Cognitive functioning score at pre-screening for first implantation.
11000015|NCT01053013|OG001|Outcome|Implant 1: Day 30|EORTC/Cognitive functioning score at day 30 after first implantation.
11000016|NCT01053013|OG002|Outcome|Implant 1: Day 60|EORTC/Cognitive functioning score at day 60 after first implantation.
11000017|NCT01053013|OG003|Outcome|Implant 2: Day 0|EORTC/Cognitive functioning score at pre-screening for second implantation (day 90 following first implantation).
11000018|NCT01053013|OG004|Outcome|Implant 2: Day 30|EORTC/Cognitive functioning score at day 30 after second implantation.
11000019|NCT01053013|OG005|Outcome|Implant 2: Day 60|EORTC/Cognitive functioning score at day 60 after second implantation.
11000020|NCT01053013|OG000|Outcome|Implant 1: Day 0|EORTC/Social functioning score at pre-screening for first implantation.
11000021|NCT01053013|OG001|Outcome|Implant 1: Day 30|EORTC/Social functioning score at day 30 after first implantation.
11000022|NCT01053013|OG002|Outcome|Implant 1: Day 60|EORTC/Social functioning score at day 60 after first implantation.
11000023|NCT01053013|OG003|Outcome|Implant 2: Day 0|EORTC/Social functioning score at pre-screening for second implantation (day 90 following first implantation).
11000024|NCT01053013|OG004|Outcome|Implant 2: Day 30|EORTC/Social functioning score at day 30 after second implantation.
11000025|NCT01053013|OG005|Outcome|Implant 2: Day 60|EORTC/Social functioning score at day 60 after second implantation.
11000026|NCT01053013|OG000|Outcome|Implant 1: Day 0|Pain assessment score at pre-screening for first implantation.
11000027|NCT01053013|OG001|Outcome|Implant 1: Day 14|Pain assessment score at day 14 after first implantation.
11000028|NCT01053013|OG002|Outcome|Implant 1: Day 30|Pain assessment score at day 30 after first implantation.
11000029|NCT01053013|OG003|Outcome|Implant 1: Day 60|Pain assessment score at day 60 after first implantation.
11000030|NCT01053013|OG004|Outcome|Implant 2: Day 0|Pain assessment score at pre-screening for second implantation (day 90 following first implantation).
11000031|NCT01053013|OG005|Outcome|Implant 2: Day 14|Pain assessment score at day 14 after second implantation.
11000032|NCT01053013|OG006|Outcome|Implant 2: Day 30|EORTC/Pain assessment score at day 30 after second implantation.
11000033|NCT01053013|OG007|Outcome|Implant 2: Day 60|Pain assessment score at day 60 after second implantation.
11000034|NCT01053013|EG000|Reported Event|Metastatic Colorectal Cancer (mCRC) Participants|Metastatic colorectal cancer (mCRC) patients who underwent at least 1 (and up to 4) implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.
11000035|NCT01053013|EG001|Reported Event|Pancreatic Cancer Participants|Pancreatic cancer patients who underwent at least 1 (and up to 3) implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.
11000036|NCT01053078|BG000|Baseline|Naltrexone|1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days
11000037|NCT01053078|BG001|Baseline|Placebo|1 month treatment; placebo tablet once daily for 28 days
11000038|NCT01053078|BG002|Baseline|Total|Total of all reporting groups
11000039|NCT01053078|FG000|Participant Flow|Naltrexone|1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days
11000040|NCT01053078|FG001|Participant Flow|Placebo|1 month treatment; placebo tablet once daily for 28 days
11000041|NCT01053078|OG000|Outcome|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
11000042|NCT01053078|OG001|Outcome|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
11000043|NCT01053078|OG000|Outcome|Naltrexone|1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days
11000044|NCT01053078|OG001|Outcome|Placebo|1 month treatment; placebo tablet once daily for 28 days
11000045|NCT01053078|EG000|Reported Event|Naltrexone|1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days
11000046|NCT01053078|EG001|Reported Event|Placebo|1 month treatment; placebo tablet once daily for 28 days
11000047|NCT01053156|BG000|Baseline|Minocycline First, Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
11000048|NCT01053156|BG001|Baseline|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
11000049|NCT01053156|BG002|Baseline|Total|Total of all reporting groups
11000050|NCT01053156|FG000|Participant Flow|Minocycline First, Then Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
11000051|NCT01053156|FG001|Participant Flow|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
11000052|NCT01053156|OG000|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
11000053|NCT01053156|OG001|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
11000054|NCT01053156|OG000|Outcome|Baseline|Prior to any intervention being started.
11000055|NCT01053156|OG001|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
11000056|NCT01053156|OG002|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
11000057|NCT01053156|EG000|Reported Event|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
11000058|NCT01053156|EG001|Reported Event|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
11000059|NCT01053247|BG000|Baseline|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
11000060|NCT01053247|BG001|Baseline|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
11000061|NCT01053247|BG002|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
11000062|NCT01053247|BG003|Baseline|Total|Total of all reporting groups
11000063|NCT01053247|FG000|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
11000064|NCT01053247|FG001|Participant Flow|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
11000065|NCT01053247|FG002|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
11000066|NCT01053247|OG000|Outcome|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
11000067|NCT01053247|OG001|Outcome|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
11000068|NCT01053247|OG002|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
11000069|NCT01053247|EG000|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
11000070|NCT01053247|EG001|Reported Event|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
11000071|NCT01053247|EG002|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
11000072|NCT01053312|BG000|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
11000073|NCT01053312|FG000|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
11000074|NCT01053312|OG000|Outcome|Subject 201-0001|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
11000075|NCT01053312|OG001|Outcome|Subject 201-0002|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
11000076|NCT01053312|OG002|Outcome|Subject 201-0003|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
11000077|NCT01053312|OG003|Outcome|Subject 201-0004|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
11000078|NCT01053312|OG004|Outcome|Subject 201-0005|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
11000079|NCT01053312|OG005|Outcome|Subject 201-0006|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
11000080|NCT01053312|OG006|Outcome|Subject 201-0007|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
11000081|NCT01053312|OG000|Outcome|Subject 201-0001|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
11000082|NCT01053312|OG001|Outcome|Subject 201-0002|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
11000083|NCT01053312|OG002|Outcome|Subject 201-0003|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
11000084|NCT01053312|OG003|Outcome|Subject 201-0004|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
11000085|NCT01053312|OG004|Outcome|Subject 201-0005|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
11000086|NCT01053312|OG005|Outcome|Subject 201-0006|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
11000087|NCT01053312|OG006|Outcome|Subject 201-0007|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
11000088|NCT01053312|OG000|Outcome|Amyloid Level (Plaque Load)|Amlyoid level estimate from the Immunohistochemistry assay: Percent plaque area (average across slides) for mAb NAB228.
11000089|NCT01053312|EG000|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
11000090|NCT01053429|BG000|Baseline|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
11000091|NCT01053429|FG000|Participant Flow|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
11000092|NCT01053429|OG000|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
11000093|NCT01053429|EG000|Reported Event|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
11000094|NCT01053507|BG000|Baseline|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
11000095|NCT01053507|BG001|Baseline|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
11000096|NCT01053507|BG002|Baseline|Total|Total of all reporting groups
11000097|NCT01053507|FG000|Participant Flow|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
11000098|NCT01053507|FG001|Participant Flow|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
11000099|NCT01053507|OG000|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
11000100|NCT01053507|OG001|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
11000101|NCT01053507|EG000|Reported Event|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
11000102|NCT01053507|EG001|Reported Event|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
11000103|NCT01053663|BG000|Baseline|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000104|NCT01053663|BG001|Baseline|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000105|NCT01053663|BG002|Baseline|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000106|NCT01053663|BG003|Baseline|Total|Total of all reporting groups
11000107|NCT01053663|FG000|Participant Flow|Oseltamivir - All Participants|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's age. Participants aged 91 to less than (<) 365 days received 3 milligrams per kilogram (mg/kg); participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000108|NCT01053663|OG000|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000109|NCT01053663|OG001|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000110|NCT01053663|OG002|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000111|NCT01053663|OG003|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000112|NCT01053663|EG000|Reported Event|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000113|NCT01053663|EG001|Reported Event|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000114|NCT01053663|EG002|Reported Event|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000115|NCT01053663|EG003|Reported Event|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
11000116|NCT01053741|BG000|Baseline|Seminal Fluid Then Normosol|"2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled Normosol-R administered rectally X1.~Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.~Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle."
11000117|NCT01053741|BG001|Baseline|Normosol-R Then Seminal Fluid|"2.5 mL radiolabeled Normosol-R administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled autologous seminal fluid administered rectally X1.~Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.~Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle."
11000118|NCT01053741|BG002|Baseline|Total|Total of all reporting groups
11000119|NCT01053741|FG000|Participant Flow|Seminal Fluid, Then Normosol-R|Subjects first received 2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Than a two week pause between interventions. Followed by 2.5 mL radiolabeled Normosol-R administered rectally x1.
11000120|NCT01053741|FG001|Participant Flow|Normosol-R Then Seminal Fluid|Subjects first received 2.5 mL radiolabeled Normosol-R administered rectally x1. Then a two week pause between interventions. Followed by 2.5 mL radiolabeled autologous seminal fluid administered rectally x1.
11000121|NCT01053741|OG000|Outcome|Seminal Fluid|Seminal Fluid Intervention
11000122|NCT01053741|OG001|Outcome|Normosol-R|Normosol-R Intervention
11000123|NCT01053741|EG000|Reported Event|Seminal Fluid|Seminal Fluid Intervention
11000124|NCT01053741|EG001|Reported Event|Normosol-R|Normosol-R Intervention
11000125|NCT01053819|BG000|Baseline|Etanercept|open label treatment per FDA approval for 24 weeks
11000126|NCT01053819|FG000|Participant Flow|Etanercept|Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.
11000127|NCT01053819|OG000|Outcome|Etanercept|open label treatment per FDA approval for 24 weeks
11000128|NCT01053819|OG000|Outcome|Etanercept|Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.
11000129|NCT01053819|EG000|Reported Event|Etanercept|open label treatment per FDA approval for 24 weeks
11000130|NCT01053897|BG000|Baseline|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
11000131|NCT01053897|FG000|Participant Flow|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
11000132|NCT01053897|OG000|Outcome|GBT009|All subjects acted as their own control receiving both GBT009 and Placebo
11000133|NCT01053897|OG001|Outcome|Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
11000134|NCT01053897|OG000|Outcome|GBT009|GBT009 treated scar segment preferred
11000135|NCT01053897|OG001|Outcome|Placebo|Placebo treated scar segment preferred
11000136|NCT01053897|OG002|Outcome|No Difference|No scar segment was preferred to the other
11000137|NCT01053897|OG000|Outcome|GBT009|Therapy treated scar segment
11000138|NCT01053897|OG001|Outcome|Placebo|Placebo treated scar segment
11000139|NCT01053897|EG000|Reported Event|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
11000140|NCT01053962|BG000|Baseline|SP-304 1.0 mg|Subjects receiving SP-304 1.0 mg for 14 consecutive days
11000141|NCT01053962|BG001|Baseline|SP-304 3.0 mg|Subjects receiving SP-304 3.0 mg for 14 consecutive days
11000142|NCT01053962|BG002|Baseline|SP-304 9.0 mg|Subjects receiving SP-304 9.0 mg for 14 consecutive days
11000143|NCT01053962|BG003|Baseline|Placebo|Subjects receiving Placebo for 14 consecutive days
11000144|NCT01053962|BG004|Baseline|SP-304 0.3 mg|Subjects receiving SP-304 0.3 mg for 14 consecutive days.
11000145|NCT01053962|BG005|Baseline|Total|Total of all reporting groups
11000146|NCT01053962|FG000|Participant Flow|SP-304 0.3 mg|Subjects receiving SP-304 0.3 mg for 14 consecutive days.
11000147|NCT01053962|FG001|Participant Flow|SP-304 1.0 mg|Subjects receiving SP-304 1.0 mg for 14 consecutive days
11000148|NCT01053962|FG002|Participant Flow|SP-304 3.0 mg|Subjects receiving SP-304 3.0 mg for 14 consecutive days
11000149|NCT01053962|FG003|Participant Flow|SP-304 9.0 mg|Subjects receiving SP-304 9.0 mg for 14 consecutive days
11000150|NCT01053962|FG004|Participant Flow|Placebo|Subjects receiving Placebo for 14 consecutive days
11000151|NCT01053962|OG000|Outcome|SP-304 0.3 mg|Subjects receiving SP-304 0.3 mg for 14 consecutive days.
11000152|NCT01053962|OG001|Outcome|SP-304 1.0 mg|Subjects receiving SP-304 1.0 mg for 14 consecutive days
11000153|NCT01053962|OG002|Outcome|SP-304 3.0 mg|Subjects receiving SP-304 3.0 mg for 14 consecutive days
11000154|NCT01053962|OG003|Outcome|SP-304 9.0 mg|Subjects receiving SP-304 9.0 mg for 14 consecutive days
11000155|NCT01053962|OG004|Outcome|Placebo|Subjects receiving Placebo for 14 consecutive days
11000156|NCT01053962|OG000|Outcome|SP-304 0.3 mg|"Subjects receiving SP-304 0.3 mg for 14 consecutive days.~SP-304 0.3 mg: Subjects receiving SP-304 0.3 mg for 14 consecutive"
11000157|NCT01053962|OG001|Outcome|SP-304 1.0 mg|"Subjects receiving SP-304 1.0 mg for 14 consecutive days~SP-304: Subjects receiving SP-304 1.0 mg for 14 consecutive days"
11000158|NCT01053962|OG002|Outcome|SP-304 3.0 mg|"Subjects receiving SP-304 3.0 mg for 14 consecutive days~SP-304: Subjects receiving SP-304 3.0 mg for 14 consecutive days"
11000159|NCT01053962|OG003|Outcome|SP-304 9.0 mg|"Subjects receiving SP-304 9.0 mg for 14 consecutive days~SP-304: Subjects receiving SP-304 9.0 mg for 14 consecutive days"
11224000|NCT02357368|FG002|Participant Flow|Levonorgestrel Intrauterine Device (Lng-IUD)|Participants receiving a standard Mirena intrauterine device (IUD) that was placed at study Week 3 by a trained clinician
11000160|NCT01053962|OG004|Outcome|Placebo|"Subjects receiving Placebo for 14 consecutive days~Placebo: Subjects receiving Placebo for 14 consecutive days"
11000161|NCT01053962|EG000|Reported Event|SP-304 0.3 mg|Subjects receiving SP-304 0.3 mg for 14 consecutive days.
11000162|NCT01053962|EG001|Reported Event|SP-304 1.0 mg|Subjects receiving SP-304 1.0 mg for 14 consecutive days
11000163|NCT01053962|EG002|Reported Event|SP-304 3.0 mg|Subjects receiving SP-304 3.0 mg for 14 consecutive days
11000164|NCT01053962|EG003|Reported Event|SP-304 9.0 mg|Subjects receiving SP-304 9.0 mg for 14 consecutive days
11000165|NCT01053962|EG004|Reported Event|Placebo|Subjects receiving Placebo for 14 consecutive days
11000166|NCT01053988|BG000|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
11000167|NCT01053988|BG001|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
11000168|NCT01053988|BG002|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
11000169|NCT01053988|BG003|Baseline|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
11000170|NCT01053988|BG004|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
11000171|NCT01053988|BG005|Baseline|Total|Total of all reporting groups
11000172|NCT01053988|FG000|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
11000173|NCT01053988|FG001|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
11224001|NCT02357368|FG003|Participant Flow|ParaGard® T 380A Intrauterine Copper Contraceptive|Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
11224002|NCT02357368|OG000|Outcome|Depot Medroxyprogesterone Acetate (DMPA)|Participants receiving DMPA administered every 12 weeks at the standard dose of 150 mg intramuscular injection, beginning from Week 3 of study enrollment and repeated at Week 15
11000174|NCT01053988|FG002|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
11000175|NCT01053988|FG003|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
11000176|NCT01053988|FG004|Participant Flow|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
11000177|NCT01053988|FG005|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
11000178|NCT01053988|OG000|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
11000179|NCT01053988|OG001|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
11000180|NCT01053988|OG002|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
11000181|NCT01053988|OG003|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
11000182|NCT01053988|OG004|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
11000183|NCT01053988|EG000|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
11000184|NCT01053988|EG001|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
11000185|NCT01053988|EG002|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
11000186|NCT01053988|EG003|Reported Event|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
11000187|NCT01053988|EG004|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
11000188|NCT01054079|BG000|Baseline|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
11000189|NCT01054079|FG000|Participant Flow|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
11000190|NCT01054079|OG000|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
11000191|NCT01054079|EG000|Reported Event|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
11000192|NCT01054144|BG000|Baseline|Response Adapted Therapy|"Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.~Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;~Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;~Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;~Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;~Dose Level -4: Discontinue~Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;~Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;~Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;~Dose level -3: Discontinue~Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;~Dose level -1: 20 mg daily on days 1 - 4 every 28 days;~Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;~Dose level -2: 10 mg daily on days 1 - 4 every 28 days;~Dose level -3: Discontinue"
11000193|NCT01054144|FG000|Participant Flow|Response Adapted Therapy|"Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.~Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;~Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;~Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;~Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;~Dose Level -4: Discontinue~Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;~Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;~Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;~Dose level -3: Discontinue~Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;~Dose level -1: 20 mg daily on days 1 - 4 every 28 days;~Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;~Dose level -2: 10 mg daily on days 1 - 4 every 28 days;~Dose level -3: Discontinue"
11000194|NCT01054144|OG000|Outcome|Response Adapted Therapy|"Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.~Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;~Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;~Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;~Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;~Dose Level -4: Discontinue~Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;~Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;~Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;~Dose level -3: Discontinue~Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;~Dose level -1: 20 mg daily on days 1 - 4 every 28 days;~Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;~Dose level -2: 10 mg daily on days 1 - 4 every 28 days;~Dose level -3: Discontinue"
11000195|NCT01054144|OG000|Outcome|Response Adapted Therapy|Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
11000196|NCT01054144|OG001|Outcome|Single Agent Lenalidomide|Participants treated with single agent lenalidomide
11000197|NCT01054144|OG000|Outcome|Single Agent|Participants who were treated with single agent lenalidomide only
11000198|NCT01054144|EG000|Reported Event|All Participants|All participants treated with Lenalidomide, prednisone and lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
11000199|NCT01054170|BG000|Baseline|AZD9668|AZD9668 2x30mg bid
11000200|NCT01054170|BG001|Baseline|Placebo|Placebo 2 tablets bid
11000201|NCT01054170|BG002|Baseline|Total|Total of all reporting groups
11000202|NCT01054170|FG000|Participant Flow|AZD9668|AZD9668 2x30mg bid
11000203|NCT01054170|FG001|Participant Flow|Placebo|Placebo 2 tablets bid
11000204|NCT01054170|OG000|Outcome|AZD9668|AZD9668 2x30mg bid
11000205|NCT01054170|OG001|Outcome|Placebo|Placebo 2 tablets bid
11000206|NCT01054170|EG000|Reported Event|AZD9668|AZD9668 2x30mg bid
11000207|NCT01054170|EG001|Reported Event|Placebo|Placebo 2 tablets bid
11000208|NCT01054183|BG000|Baseline|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
11000209|NCT01054183|BG001|Baseline|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
11000210|NCT01054183|BG002|Baseline|Total|Total of all reporting groups
11000211|NCT01054183|FG000|Participant Flow|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
11000212|NCT01054183|FG001|Participant Flow|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
11000213|NCT01054183|OG000|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
11000214|NCT01054183|OG001|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
11000215|NCT01054183|EG000|Reported Event|GlideScope Video Laryngoscope Ranger(GVL)|Procedure used to perform tracheal intubation that facilitates indirect visualization of the glottis through a video display.
11224003|NCT02357368|OG001|Outcome|Etonogestrel Impant (Eng-Implant)|Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
11000216|NCT01054183|EG001|Reported Event|Direct Laryngoscopy|Procedure used to visualize the vocal cords and perform tracheal intubation in the pediatric and neonatal population.
11000217|NCT01054209|BG000|Baseline|A Control: Standard Care|Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician
11000218|NCT01054209|BG001|Baseline|B Intervention: Warming Mattress|"Warming mattress activated otherwise same management as Arm A.~Warming with warming mattress: Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.~Inditherm Alpha systems, OTM1: 1900mm x 585mm"
11000219|NCT01054209|BG002|Baseline|Total|Total of all reporting groups
11000220|NCT01054209|FG000|Participant Flow|A Control: Standard Care|Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician
11000221|NCT01054209|FG001|Participant Flow|B Intervention: Warming Mattress|"Warming mattress activated otherwise same management as Arm A.~Warming with warming mattress: Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.~Inditherm Alpha systems, OTM1: 1900mm x 585mm"
11000222|NCT01054209|OG000|Outcome|A: Control Arm: Standard Care|Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician
11000223|NCT01054209|OG001|Outcome|B: Intervention: Warming Mattress|"Warming mattress activated otherwise same management as Arm A.~Warming with warming mattress: Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.~Inditherm Alpha systems, OTM1: 1900mm x 585mm"
11000224|NCT01054209|EG000|Reported Event|A Control: Standard Care|Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician
11000225|NCT01054209|EG001|Reported Event|B Intervention: Warming Mattress|"Warming mattress activated otherwise same management as Arm A.~Warming with warming mattress: Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.~Inditherm Alpha systems, OTM1: 1900mm x 585mm"
11000226|NCT01054222|BG000|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
11000227|NCT01054222|FG000|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
11000228|NCT01054222|OG000|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
11000229|NCT01054222|EG000|Reported Event|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
11000230|NCT01054300|BG000|Baseline|Cohort 1|Period 1: participants received a total daily dose of ertugliflozin 2 mg for 1 day; Period 2: participants received a total daily dose of ertugliflozin 2 mg for 1 day
11000231|NCT01054300|BG001|Baseline|Cohort 2|Period 1: participants received a total daily dose of ertugliflozin 4 mg; Period 2: participants received a total daily dose of ertugliflozin 4 mg for 1 day
11000232|NCT01054300|BG002|Baseline|Total|Total of all reporting groups
11000233|NCT01054300|FG000|Participant Flow|Cohort 1: Ertu 2 mg/Pbo→Ertu 1 mg/Ertu 1 mg|Period 1: Ertugliflozin (Ertu) 2 mg in the AM and placebo (Pbo) in the PM for 1 day. Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
11000234|NCT01054300|FG001|Participant Flow|Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo|Period 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
11000235|NCT01054300|FG002|Participant Flow|Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg|Period 1: Ertu 4 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
11000236|NCT01054300|FG003|Participant Flow|Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/P|Period 1: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. Period 2: Ertu 4 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
11000237|NCT01054300|OG000|Outcome|Cohort 1: Ertugliflozin 1 mg Twice Daily|Participants received ertugliflozin 1 mg twice daily for 1 day
11000238|NCT01054300|OG001|Outcome|Cohort 1: Ertugliflozin 2 mg Once Daily|Participants received ertugliflozin 2 mg once daily for 1 day
11000239|NCT01054300|OG002|Outcome|Cohort 2: Ertugliflozin 2 mg Twice Daily|Participants received ertugliflozin 2 mg twice daily for 1 day
11224004|NCT02357368|OG002|Outcome|Levonorgestrel Intrauterine Device (Lng-IUD)|Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
11224005|NCT02357368|OG003|Outcome|ParaGard® T 380A Intrauterine Copper Contraceptive|Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
11000240|NCT01054300|OG003|Outcome|Cohort 2: Ertugliflozin 4 mg Once Daily|Participants received ertugliflozin 4 mg once daily for 1 day
11000241|NCT01054300|EG000|Reported Event|Cohort 1: Ertugliflozin 1 mg Twice Daily|Participants received ertugliflozin 1 mg twice daily for 1 day
11000242|NCT01054300|EG001|Reported Event|Cohort 1: Ertugliflozin 2 mg Once Daily|Participants received ertugliflozin 2 mg once daily for 1 day
11000243|NCT01054300|EG002|Reported Event|Cohort 2: Ertugliflozin 2 mg Twice Daily|Participants received ertugliflozin 2 mg twice daily for 1 day
11000244|NCT01054300|EG003|Reported Event|Cohort 2: Ertugliflozin 4 mg Once Daily|Participants received ertugliflozin 4 mg once daily for 1 day
11000245|NCT01054339|BG000|Baseline|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections distributed across a single muscle site
11000246|NCT01054339|BG001|Baseline|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 32 IM injections distributed across three muscle sites
11000247|NCT01054339|BG002|Baseline|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 100 IM injections distributed across 10 muscle sites
11000248|NCT01054339|BG003|Baseline|Total|Total of all reporting groups
11000249|NCT01054339|FG000|Participant Flow|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections distributed across a single muscle site
10877790|NCT00449007|BG001|Baseline|Bupropion|"bupropion -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~bupropion: 6 months"
10877791|NCT00449007|BG002|Baseline|Total|Total of all reporting groups
10877792|NCT00449007|FG000|Participant Flow|Fluoxetine|"fluoxetine -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~fluoxetine: 6 months"
10877793|NCT00449007|FG001|Participant Flow|Bupropion|"bupropion -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~bupropion: 6 months"
10877794|NCT00449007|OG000|Outcome|Fluoxetine for 6 Months|"fluoxetine -- patients randomized to one of two arms for 6 months and assessed weekly for 8 weeks and then monthly. patients receive 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~fluoxetine: 6 months"
10877795|NCT00449007|OG001|Outcome|Bupropion for 6 Months|"bupropion fluoxetine -- patients randomized to one of two arms for 6 months and assessed weekly for 8 weeks and then monthly. patients receive 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~: bupropion: 6 months"
10877796|NCT00449007|OG000|Outcome|Fluoxetine 6 Months of Antidepressant|"fluoxetine -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~fluoxetine: 6 months"
10877797|NCT00449007|OG001|Outcome|Bupropion 6 Months of Antidepressant|"bupropion -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~bupropion: 6 months"
10877798|NCT00449007|EG000|Reported Event|Arm 1 Randomized to Fluoxetine|"fluoxetine -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~fluoxetine: 6 months"
10877799|NCT00449007|EG001|Reported Event|Arm 2 Randomized to Bupropion|"bupropion -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings~bupropion: 6 months"
10877800|NCT00449033|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
10877801|NCT00449033|BG001|Baseline|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
10877802|NCT00449033|BG002|Baseline|Total|Total of all reporting groups
10877803|NCT00449033|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
10877804|NCT00449033|FG001|Participant Flow|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
10877805|NCT00449033|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
10879501|NCT00458237|FG001|Participant Flow|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10879502|NCT00458237|FG002|Participant Flow|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10879503|NCT00458237|OG000|Outcome|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10879504|NCT00458237|OG001|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
11000250|NCT01054339|FG001|Participant Flow|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 32 IM injections distributed across three muscle sites
11000251|NCT01054339|FG002|Participant Flow|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 100 IM injections distributed across 10 muscle sites
11000252|NCT01054339|OG000|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections distributed across a single muscle site
11000253|NCT01054339|OG001|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as a total of 32 IM injections distributed across three muscle sites
11000254|NCT01054339|OG002|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as100 IM injections distributed across 10 muscle sites
11000255|NCT01054339|OG001|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 32 IM injections distributed across three muscle sites
11000256|NCT01054339|OG002|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 100 IM injections distributed across 10 muscle sites
11000257|NCT01054339|EG000|Reported Event|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections distributed across a single muscle site
11000258|NCT01054339|EG001|Reported Event|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 32 IM injections distributed across three muscle sites
11000259|NCT01054339|EG002|Reported Event|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 100 IM injections distributed across 10 muscle sites
11000260|NCT01054404|BG000|Baseline|Furosemide|Furosemide : Furosemide 0.3 mg/kg
11000261|NCT01054404|BG001|Baseline|Placebo|Placebo : Placebo (up to 5mL)
11000262|NCT01054404|BG002|Baseline|Total|Total of all reporting groups
11000263|NCT01054404|FG000|Participant Flow|Furosemide|Furosemide : Furosemide 0.3 mg/kg
11224006|NCT02357368|EG000|Reported Event|Depot Medroxyprogesterone Acetate (DMPA)|Participants receiving DMPA administered every 12 weeks at the standard dose of 150 mg intramuscular injection, beginning from Week 3 of study enrollment and repeated at Week 15
11000264|NCT01054404|FG001|Participant Flow|Placebo|Placebo : Placebo (up to 5mL)
11000265|NCT01054404|OG000|Outcome|Furosemide|Furosemide : Furosemide 0.3 mg/kg
11000266|NCT01054404|OG001|Outcome|Placebo|Placebo : Placebo (up to 5mL)
11000267|NCT01054404|EG000|Reported Event|Furosemide|Furosemide : Furosemide 0.3 mg/kg
11000268|NCT01054404|EG001|Reported Event|Placebo|Placebo : Placebo (up to 5mL)
11000269|NCT01054443|BG000|Baseline|Placebo|Participants received placebo tablets orally once a day for 42 days.
11000270|NCT01054443|BG001|Baseline|Lusutrombopag 0.5 mg|Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
11000271|NCT01054443|BG002|Baseline|Lusutrombopag 0.75 mg|Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
11000272|NCT01054443|BG003|Baseline|Lusutrombopag 1.0 mg|Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
11000273|NCT01054443|BG004|Baseline|Total|Total of all reporting groups
11000274|NCT01054443|FG000|Participant Flow|Placebo|Participants received placebo tablets orally once a day for 42 days.
11000275|NCT01054443|FG001|Participant Flow|Lusutrombopag 0.5 mg|Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
11000276|NCT01054443|FG002|Participant Flow|Lusutrombopag 0.75 mg|Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
11000277|NCT01054443|FG003|Participant Flow|Lusutrombopag 1.0 mg|Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
11000278|NCT01054443|OG000|Outcome|Placebo|Participants received placebo tablets orally once a day for 42 days.
11000279|NCT01054443|OG001|Outcome|Lusutrombopag 0.5 mg|Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
11000280|NCT01054443|OG002|Outcome|Lusutrombopag 0.75 mg|Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
11000281|NCT01054443|OG003|Outcome|Lusutrombopag 1.0 mg|Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
11000282|NCT01054443|OG000|Outcome|Lusutrombopag 0.5 mg|Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
11000283|NCT01054443|OG001|Outcome|Lusutrombopag 0.75 mg|Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
11000284|NCT01054443|OG002|Outcome|Lusutrombopag 1.0 mg|Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
11000285|NCT01054443|EG000|Reported Event|Placebo|Participants received placebo tablets orally once a day for 42 days.
11000286|NCT01054443|EG001|Reported Event|Lusutrombopag 0.5 mg|Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
11000287|NCT01054443|EG002|Reported Event|Lusutrombopag 0.75 mg|Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
11000288|NCT01054443|EG003|Reported Event|Lusutrombopag 1.0 mg|Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
11000289|NCT01054456|BG000|Baseline|All Participants: Palonosetron 0.25 mg/5 mL|Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
11000290|NCT01054456|FG000|Participant Flow|All Participants: Palonosetron 0.25 mg/5 mL|Participants received palonosetron 0.25 milligram (mg) per (/) 5 milliliter (mL) intravenous injection 30 minutes prior to receiving a low emetogenic chemotherapy (LEC) agent on Day 1.
11000291|NCT01054456|OG000|Outcome|All Participants: Palonosetron 0.25 mg/5 mL|Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
11000292|NCT01054456|EG000|Reported Event|All Participants: Palonosetron 0.25 mg/5 mL|Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
11000293|NCT01054560|BG000|Baseline|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
11000294|NCT01054560|BG001|Baseline|MERCI® Device|The MERCI® Device (control device) is commercially available.
11000295|NCT01054560|BG002|Baseline|Total|Total of all reporting groups
11224007|NCT02357368|EG001|Reported Event|Etonogestrel Impant (Eng-Implant)|Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
11224008|NCT02357368|EG002|Reported Event|Levonorgestrel Intrauterine Device (Lng-IUD)|Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
11000296|NCT01054560|FG000|Participant Flow|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
11000297|NCT01054560|FG001|Participant Flow|MERCI® Device|The MERCI® Device (control device) is commercially available.
11000298|NCT01054560|OG000|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
11000299|NCT01054560|OG001|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
11000300|NCT01054560|OG000|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
11000301|NCT01054560|OG001|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
11000302|NCT01054560|EG000|Reported Event|The SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
11000303|NCT01054560|EG001|Reported Event|The MERCI® Device|The MERCI® Device (control device) is commercially available.
11000304|NCT01054573|BG000|Baseline|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
11000305|NCT01054573|BG001|Baseline|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
11000306|NCT01054573|BG002|Baseline|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
11000307|NCT01054573|BG003|Baseline|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
11000308|NCT01054573|BG004|Baseline|Total|Total of all reporting groups
11000309|NCT01054573|FG000|Participant Flow|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
11000310|NCT01054573|FG001|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
11000311|NCT01054573|FG002|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
11000312|NCT01054573|FG003|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
11000313|NCT01054573|OG000|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
11000314|NCT01054573|OG001|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
11000315|NCT01054573|OG002|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
11000316|NCT01054573|OG003|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
11000317|NCT01054573|OG000|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
11000318|NCT01054573|OG001|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
11007687|NCT01092442|FG000|Participant Flow|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
10845744|NCT00269477|BG003|Baseline|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
11000319|NCT01054573|OG002|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
11000320|NCT01054573|OG000|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 32, 31, 23, 18, and 16, respectively.
11000321|NCT01054573|OG001|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 22, 20, 19, and 16, respectively.
11000322|NCT01054573|OG002|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 27, 26, 26, 26, 24, 23, and 21, respectively.
11000323|NCT01054573|OG003|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 9, 9, 8, 7, and 7, respectively.
11000324|NCT01054573|OG000|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 31, 23, 18, and 15, respectively.
11000325|NCT01054573|OG001|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 20, 19, and 16, respectively.
11000326|NCT01054573|OG002|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 26, 26, 26, 24, 23, and 21, respectively.
11000327|NCT01054573|OG003|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 8, 7, and 7, respectively.
11000328|NCT01054573|EG000|Reported Event|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
11000329|NCT01054573|EG001|Reported Event|Phase 3: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons (ncludes all participants, ie, those categorized as prior null responders, prior partial responders, and prior relapsers).
11000330|NCT01054586|BG000|Baseline|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
11000331|NCT01054586|BG001|Baseline|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
11000332|NCT01054586|BG002|Baseline|FPV, Other|All other dosages of Fosamprenavir
11000333|NCT01054586|BG003|Baseline|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
11000334|NCT01054586|BG004|Baseline|Total|Total of all reporting groups
11000335|NCT01054586|FG000|Participant Flow|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
11000336|NCT01054586|FG001|Participant Flow|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
11000337|NCT01054586|FG002|Participant Flow|FPV, Other|All other dosages of FPV (excluding FPV 700 mg BID/RTV 100 mg BID and FPV 700 mg BID/RTV 100 mg QD)
11000338|NCT01054586|FG003|Participant Flow|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
11000339|NCT01054586|OG000|Outcome|ART naïve|Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
11000340|NCT01054586|OG001|Outcome|Not ART naïve|Patients who have previously been exposed to ART therapy
11000341|NCT01054586|OG000|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
11000342|NCT01054586|OG001|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
10845745|NCT00269477|BG004|Baseline|Total|Total of all reporting groups
11000343|NCT01054586|OG002|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
11000344|NCT01054586|OG002|Outcome|FPV, Other|All other dosages of Fosamprenavir
11000345|NCT01054586|OG003|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
11000346|NCT01054586|OG001|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
11000347|NCT01054586|OG003|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
11000348|NCT01054586|OG000|Outcome|FPV 700 mg BID/RTV 100 mg BID|
11000349|NCT01054586|OG001|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
11000350|NCT01054586|OG000|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
11000351|NCT01054586|OG001|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
11000352|NCT01054586|OG000|Outcome|All Participants|All Participants, across all arms
11000353|NCT01054586|EG000|Reported Event|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
11000354|NCT01054586|EG001|Reported Event|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
11000355|NCT01054586|EG002|Reported Event|FPV, Other|All other dosages of Fosamprenavir
11000356|NCT01054586|EG003|Reported Event|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
11000357|NCT01054599|BG000|Baseline|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
11000358|NCT01054599|BG001|Baseline|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
11000359|NCT01054599|BG002|Baseline|Total|Total of all reporting groups
11000360|NCT01054599|FG000|Participant Flow|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
11000361|NCT01054599|FG001|Participant Flow|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
11000362|NCT01054599|OG000|Outcome|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
11000363|NCT01054599|OG001|Outcome|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
11000364|NCT01054599|EG000|Reported Event|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
11000365|NCT01054599|EG001|Reported Event|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
11000366|NCT01054625|BG000|Baseline|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
11000367|NCT01054625|BG001|Baseline|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
11000368|NCT01054625|BG002|Baseline|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
11000369|NCT01054625|BG003|Baseline|Total|Total of all reporting groups
11000370|NCT01054625|FG000|Participant Flow|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
11000371|NCT01054625|FG001|Participant Flow|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
11000372|NCT01054625|FG002|Participant Flow|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
11000373|NCT01054625|OG000|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
11000374|NCT01054625|OG001|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
11000375|NCT01054625|OG002|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
11000376|NCT01054625|EG000|Reported Event|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
11000377|NCT01054625|EG001|Reported Event|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
11000378|NCT01054625|EG002|Reported Event|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
11000379|NCT01054703|BG000|Baseline|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
11000380|NCT01054703|FG000|Participant Flow|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
11000381|NCT01054703|OG000|Outcome|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
11000382|NCT01054703|EG000|Reported Event|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
11000383|NCT01054729|BG000|Baseline|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
11000384|NCT01054729|BG001|Baseline|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
11000385|NCT01054729|BG002|Baseline|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
11000386|NCT01054729|BG003|Baseline|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
11000387|NCT01054729|BG004|Baseline|Total|Total of all reporting groups
11000388|NCT01054729|FG000|Participant Flow|Sofosbuvir 100 mg+PEG+RBV|Participants received sofosbuvir 100 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
11000389|NCT01054729|FG001|Participant Flow|Sofosbuvir 200 mg+PEG+RBV|Participants received sofosbuvir 200 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
11000390|NCT01054729|FG002|Participant Flow|Sofosbuvir 400 mg+PEG+RBV|Participants received sofosbuvir 400 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
11000391|NCT01054729|FG003|Participant Flow|Placebo+PEG+RBV|Participants received placebo to match sofosbuvir for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
11000392|NCT01054729|OG000|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
11000393|NCT01054729|OG001|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
11000394|NCT01054729|OG002|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
11000395|NCT01054729|OG003|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
11000396|NCT01054729|EG000|Reported Event|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
11000397|NCT01054729|EG001|Reported Event|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
11000398|NCT01054729|EG002|Reported Event|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
11000399|NCT01054729|EG003|Reported Event|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
11000400|NCT01054742|BG000|Baseline|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
11000401|NCT01054742|FG000|Participant Flow|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
11000402|NCT01054742|OG000|Outcome|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
11000403|NCT01054742|EG000|Reported Event|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
11000404|NCT01054768|BG000|Baseline|Alpha-lipoic Acid and Acetyl-L-carnitine|"alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.~alpha-lipoic acid and acetyl-L-carnitine: none to report"
11000405|NCT01054768|BG001|Baseline|Placebo|"1400 mg placebo tablet twice a day for 6 months.~Placebo: none to report"
11000406|NCT01054768|BG002|Baseline|Total|Total of all reporting groups
11000407|NCT01054768|FG000|Participant Flow|Alpha-lipoic Acid and Acetyl-L-carnitine|"alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.~alpha-lipoic acid and acetyl-L-carnitine: none to report"
11000408|NCT01054768|FG001|Participant Flow|Placebo|"1400 mg placebo tablet twice a day for 6 months.~Placebo: none to report"
11000409|NCT01054768|OG000|Outcome|Alpha-lipoic Acid and Acetyl-L-carnitine|"alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.~alpha-lipoic acid and acetyl-L-carnitine: none to report"
11000410|NCT01054768|OG001|Outcome|Placebo|"1400 mg placebo tablet twice a day for 6 months.~Placebo: none to report"
11000411|NCT01054768|EG000|Reported Event|Alpha-lipoic Acid and Acetyl-L-carnitine|"alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.~alpha-lipoic acid and acetyl-L-carnitine: none to report"
11000412|NCT01054768|EG001|Reported Event|Placebo|"1400 mg placebo tablet twice a day for 6 months.~Placebo: none to report"
11007688|NCT01092442|FG001|Participant Flow|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
10877806|NCT00449033|OG001|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
10877807|NCT00449033|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
10877808|NCT00449033|EG001|Reported Event|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
10877809|NCT00449046|BG000|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
10877810|NCT00449046|FG000|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
10877811|NCT00449046|OG000|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
10877812|NCT00449046|EG000|Reported Event|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
10877813|NCT00449072|BG000|Baseline|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
10877814|NCT00449072|BG001|Baseline|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
10877815|NCT00449072|BG002|Baseline|Total|Total of all reporting groups
10877816|NCT00449072|FG000|Participant Flow|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
10877817|NCT00449072|FG001|Participant Flow|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
10877818|NCT00449072|OG000|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
10877819|NCT00449072|OG001|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
10877820|NCT00449072|EG000|Reported Event|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
10877821|NCT00449072|EG001|Reported Event|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
10877822|NCT00449150|BG000|Baseline|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
10877823|NCT00449150|BG001|Baseline|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
10877824|NCT00449150|BG002|Baseline|Placebo|Placebo on Week 0, 2 26 and 28
10877825|NCT00449150|BG003|Baseline|Total|Total of all reporting groups
10877826|NCT00449150|FG000|Participant Flow|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
10877827|NCT00449150|FG001|Participant Flow|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
10877828|NCT00449150|FG002|Participant Flow|Placebo|Placebo on Week 0, 2 26 and 28
10877829|NCT00449150|OG000|Outcome|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
10877830|NCT00449150|OG001|Outcome|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
10877831|NCT00449150|OG002|Outcome|Placebo|Placebo on Week 0, 2 26 and 28
10877832|NCT00449150|OG000|Outcome|Treatment Group A: Cetrorelix (CET) 78 mg + 78 mg|"Treatment course 1: Cetrorelix 78 mg + 78 mg~Week 0: 52 mg CET (2 injections)~Week 2: 26 mg CET (1 injection)~Treatment course 2:~Week 26: 52 mg CET (2 injections)~Week 28: 26 mg CET(1 injection)~4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.~Cetrorelix 78 mg + 78 mg"
11007689|NCT01092442|OG000|Outcome|Retrospective Ross|
11007690|NCT01092442|OG001|Outcome|Prospective Ross|
11007691|NCT01092442|OG002|Outcome|Retrospective Right Ventricular Outflow Tract (RVOT)|
11007692|NCT01092442|OG003|Outcome|Prospective RVOT|
11000413|NCT01054820|BG000|Baseline|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
11000414|NCT01054820|FG000|Participant Flow|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
11000415|NCT01054820|OG000|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
11000416|NCT01054820|EG000|Reported Event|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
11000417|NCT01054846|BG000|Baseline|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
11000418|NCT01054846|BG001|Baseline|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
11000419|NCT01054846|BG002|Baseline|Total|Total of all reporting groups
11000420|NCT01054846|FG000|Participant Flow|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
11000421|NCT01054846|FG001|Participant Flow|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
11000422|NCT01054846|OG000|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
11000423|NCT01054846|OG001|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
11000424|NCT01054846|EG000|Reported Event|All Study Participants|
11000425|NCT01054885|BG000|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
11000426|NCT01054885|BG001|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
11000427|NCT01054885|BG002|Baseline|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
11000428|NCT01054885|BG003|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
11000429|NCT01054885|BG004|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
11000430|NCT01054885|BG005|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
11000431|NCT01054885|BG006|Baseline|Total|Total of all reporting groups
11000432|NCT01054885|FG000|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
11000433|NCT01054885|FG001|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
11000434|NCT01054885|FG002|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
11000435|NCT01054885|FG003|Participant Flow|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
11000436|NCT01054885|FG004|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
11000437|NCT01054885|FG005|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
11000438|NCT01054885|FG006|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
11000439|NCT01054885|OG000|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
11000440|NCT01054885|OG001|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
11000441|NCT01054885|OG002|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
11000442|NCT01054885|OG003|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
11000443|NCT01054885|OG004|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
11000444|NCT01054885|OG005|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
11000445|NCT01054885|OG003|Outcome|FVI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
11000446|NCT01054885|EG000|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
11000447|NCT01054885|EG001|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
11000448|NCT01054885|EG002|Reported Event|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
11000449|NCT01054885|EG003|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
11000450|NCT01054885|EG004|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
11000451|NCT01054885|EG005|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
11000452|NCT01054911|BG000|Baseline|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
11000453|NCT01054911|FG000|Participant Flow|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
11000454|NCT01054911|OG000|Outcome|Neoadjuvant Therapy Plus Surgery|Patients received oral therapy for up to 12 weeks and re-evaluated for response. Favorable tumor reduction resulted surgical extirpation typically with less morbid operative intervention.
11000455|NCT01054911|OG001|Outcome|Neoadjuvant Therapy no Surgery|Patients received oral therapy for up to 12 weeks. Reassessment demonstrated response, but no surgical intervention
11000456|NCT01054911|OG000|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
11000457|NCT01054911|EG000|Reported Event|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
11000458|NCT01054976|BG000|Baseline|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
11000459|NCT01054976|FG000|Participant Flow|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
11000460|NCT01054976|OG000|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
11000461|NCT01054976|EG000|Reported Event|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
11000462|NCT01055028|BG000|Baseline|Regimen A Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
11000463|NCT01055028|BG001|Baseline|Regimen B Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
11000464|NCT01055028|BG002|Baseline|Total|Total of all reporting groups
11000465|NCT01055028|FG000|Participant Flow|Regimen A Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
11000466|NCT01055028|FG001|Participant Flow|Regimen B Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
11000467|NCT01055028|OG000|Outcome|Regimen A Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
11000468|NCT01055028|OG001|Outcome|Regimen B Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
11007693|NCT01092442|OG002|Outcome|Retrospective RVOT|
11007694|NCT01092442|OG000|Outcome|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
11000469|NCT01055028|OG000|Outcome|Regimen A Treatment 1|Patients were to receive paclitaxel (A) 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
11000470|NCT01055028|OG001|Outcome|Regimen B Treatment 2|Patients were to receive paclitaxel (B) 90 mg/m² weekly x 3 of a 28 day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
11000471|NCT01055028|OG000|Outcome|Regimen A / Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.~Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles.~Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days.~Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle"
11000472|NCT01055028|OG001|Outcome|Regimen B / Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.~Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles.~Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days.~Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle"
11000473|NCT01055028|EG000|Reported Event|Regimen A Treatment 1|Patients were to receive paclitaxel (A) 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
11000474|NCT01055028|EG001|Reported Event|Regimen B Treatment 2|Patients were to receive paclitaxel (B) 90 mg/m² weekly x 3 of a 28 day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
11000475|NCT01055067|BG000|Baseline|Total|All enrolled participants who received at least 1 dose of study drug in the study.
11000476|NCT01055067|FG000|Participant Flow|Total|All enrolled participants who received at least 1 dose of study drug in the study.
11000477|NCT01055067|OG000|Outcome|Stage 1: ARQ 197 360 mg BID|Participants who were enrolled in Stage 1 of the Simon 2-stage design and received ARQ 197 360 mg twice a day (BID) (with a 720 mg total daily dose) in participants with relapsed or refractory non-central nervous system germ cell tumor (non-CNS GCT).
11000478|NCT01055067|OG001|Outcome|Total|All enrolled participants who received at least 1 dose of study drug in the study.
11000479|NCT01055067|EG000|Reported Event|Stage 1: ARQ 197 360 mg BID|Participants who were enrolled in Stage 1 of the Simon 2-stage design and received ARQ 197 360 mg twice a day (BID) (with a 720 mg total daily dose) in participants with relapsed or refractory non-central nervous system germ cell tumor (non-CNS GCT).
11000480|NCT01055067|EG001|Reported Event|Total|All enrolled participants who received at least 1 dose of study drug in the study.
11000481|NCT01055132|BG000|Baseline|All Subjects|All subjects who completed the study.
11000482|NCT01055132|FG000|Participant Flow|Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second|Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days
11000483|NCT01055132|FG001|Participant Flow|Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second|Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
11000484|NCT01055132|OG000|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
11000485|NCT01055132|OG001|Outcome|Nelfilcon A Toric (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
11000486|NCT01055132|OG001|Outcome|Nelfilcon A Toric Lens (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
11000487|NCT01055132|OG000|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn 5-9 days
11000488|NCT01055132|OG001|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days
11000489|NCT01055132|OG000|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
11000490|NCT01055132|OG001|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days.
11000491|NCT01055132|EG000|Reported Event|Etafilcon A Toric / Nelfilcon A Toric|etafilcon A toric contact lens worn daily during first period of a maximum of 9 days, nelfilcon A toric contact lens worn during second period of a maximum of 9 days
11000492|NCT01055171|BG000|Baseline|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol: 40 mg; Single Administration."
11000493|NCT01055171|BG001|Baseline|Placebo|"Patient to receive placebo in this condition.~Placebo: 40 mg; Single Dose."
11000494|NCT01055171|BG002|Baseline|Total|Total of all reporting groups
11224009|NCT02357368|EG003|Reported Event|ParaGard® T 380A Intrauterine Copper Contraceptive|Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
10846627|NCT00278564|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|"Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen~Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation"
10877833|NCT00449150|OG001|Outcome|Treatment Group B: CET 78 mg + 52 mg|"Treatment course 1: Cetrorelix 78 mg + 52 mg~Week 0: 52 mg CET (2 injections)~Week 2: 26 mg CET (1 injection)~Treatment course 2:~Week 26: 52 mg CET (2 injections)~Week 28: Placebo (1 injection)~4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.~Cetrorelix 78 mg + 52 mg~Placebo"
10877834|NCT00449150|OG002|Outcome|Treatment Group C: Placebo|"Treatment course 1:~Week 0: placebo (2 injections)~Week 2: placebo (1 injection)~Treatment course 2:~Week 26: placebo (2 injections)~Week 28: placebo (1 injection)~4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.~Placebo"
10877835|NCT00449150|EG000|Reported Event|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
10877836|NCT00449150|EG001|Reported Event|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
10877837|NCT00449150|EG002|Reported Event|Placebo|Placebo on Week 0, 2 26 and 28
10877838|NCT00449163|BG000|Baseline|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
10877839|NCT00449163|FG000|Participant Flow|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
10877840|NCT00449163|OG000|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
10877841|NCT00449163|EG000|Reported Event|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
10877842|NCT00449176|BG000|Baseline|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
10877843|NCT00449176|BG001|Baseline|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
10877844|NCT00449176|BG002|Baseline|Placebo|Matching Placebo twice daily(BID)
10877845|NCT00449176|BG003|Baseline|Total|Total of all reporting groups
10877846|NCT00449176|FG000|Participant Flow|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
10877847|NCT00449176|FG001|Participant Flow|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
10877848|NCT00449176|FG002|Participant Flow|Placebo|Matching Placebo twice daily(BID)
10877849|NCT00449176|OG000|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
10877850|NCT00449176|OG001|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
10877851|NCT00449176|OG002|Outcome|Placebo|Matching Placebo twice daily(BID)
10877852|NCT00449176|EG000|Reported Event|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
10877853|NCT00449176|EG001|Reported Event|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
10877854|NCT00449176|EG002|Reported Event|Placebo|Matching Placebo twice daily(BID)
10877855|NCT00449540|BG000|Baseline|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
10877856|NCT00449540|BG001|Baseline|Sham TMS Device|Simulated Sham treatment without TMS
10877857|NCT00449540|BG002|Baseline|Total|Total of all reporting groups
10877858|NCT00449540|FG000|Participant Flow|30 Day Lead in Phase|some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase
10877859|NCT00449540|FG001|Participant Flow|Active TMS|Active Transcranial Magnetic Stimulation Device
10877860|NCT00449540|FG002|Participant Flow|Sham TMS Device|Device which does not deliver TMS pulse
10877861|NCT00449540|OG000|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
10877862|NCT00449540|OG001|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
10877863|NCT00449540|EG000|Reported Event|Active TMS Device - Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Treatment related
10877864|NCT00449540|EG001|Reported Event|Sham TMS Device - Treatment Related|Simulated Sham treatment without TMS
10877865|NCT00449540|EG002|Reported Event|Active TMS - Not Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Not treatment related
10877866|NCT00449540|EG003|Reported Event|Sham TMS Device - Not Treatment Related|Sham TMS Device - events that are not treatment related
10877867|NCT00449644|BG000|Baseline|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
10877868|NCT00449644|BG001|Baseline|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
11000495|NCT01055171|FG000|Participant Flow|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
11000496|NCT01055171|FG001|Participant Flow|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
11000497|NCT01055171|OG000|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
11000498|NCT01055171|OG001|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
11000499|NCT01055171|EG000|Reported Event|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol: 40 mg; Single Administration."
11000500|NCT01055171|EG001|Reported Event|Placebo|"Patient to receive placebo in this condition.~Placebo: 40 mg; Single Dose."
11000501|NCT01055184|BG000|Baseline|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
11000502|NCT01055184|FG000|Participant Flow|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
11000503|NCT01055184|OG000|Outcome|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
11000504|NCT01055184|EG000|Reported Event|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
11000505|NCT01055197|BG000|Baseline|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
11000506|NCT01055197|BG001|Baseline|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
11000507|NCT01055197|BG002|Baseline|Total|Total of all reporting groups
11000508|NCT01055197|FG000|Participant Flow|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
11000509|NCT01055197|FG001|Participant Flow|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
11000510|NCT01055197|OG000|Outcome|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
10845746|NCT00269477|FG000|Participant Flow|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
11000511|NCT01055197|OG001|Outcome|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
11000512|NCT01055197|EG000|Reported Event|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
11000513|NCT01055197|EG001|Reported Event|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
11000514|NCT01055223|BG000|Baseline|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
11000515|NCT01055223|FG000|Participant Flow|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
11000516|NCT01055223|OG000|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
11000517|NCT01055223|OG001|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
11000518|NCT01055223|OG002|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
11000519|NCT01055223|OG003|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
11000520|NCT01055223|OG000|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
11007695|NCT01092442|OG001|Outcome|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
11000521|NCT01055223|OG001|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
11000522|NCT01055223|OG003|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolacton, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
11000523|NCT01055223|OG003|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
11000524|NCT01055223|OG003|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
11000525|NCT01055223|EG000|Reported Event|TZD 6-month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
11000526|NCT01055223|EG001|Reported Event|TZD-12 Month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
11000527|NCT01055262|BG000|Baseline|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
11000528|NCT01055262|FG000|Participant Flow|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
11000529|NCT01055262|OG000|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
11000530|NCT01055262|EG000|Reported Event|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
11000531|NCT01055314|BG000|Baseline|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
11000532|NCT01055314|BG001|Baseline|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
11000533|NCT01055314|BG002|Baseline|Total|Total of all reporting groups
11000534|NCT01055314|FG000|Participant Flow|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
11000535|NCT01055314|FG001|Participant Flow|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
11000536|NCT01055314|OG000|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
11000537|NCT01055314|OG000|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
11000538|NCT01055314|OG001|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
11000539|NCT01055314|EG000|Reported Event|Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)|"Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50 & 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47 & 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, & 30; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28 & 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 & 44; dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41 & 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiation therapy on days 1-5 of weeks 20-24.~Cixutumumab: Given IV~Cyclophosphamide: Given IV~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Vincristine Sulfate"
11000540|NCT01055314|EG001|Reported Event|Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)|"Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiation therapy as in group 1. Patients also receive temozolomide PO on days 1-5 of weeks 1, 4, 20, 23, 47, and 50.~Cyclophosphamide: Given IV~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Vincristine Sulfate Liposome: Given IV"
11000541|NCT01055457|BG000|Baseline|Solution 1 (Etafilcon A)|All subjects that were dispensed solution 1 and the etafilcon A lens.
11000542|NCT01055457|BG001|Baseline|Solution 1 (Comfilcon A)|All subjects that were dispensed solution 1 and the comfilcon A study lens.
11000543|NCT01055457|BG002|Baseline|Solution 1 (Balafilcon A)|All subjects that were dispensed solution 1 and the balafilcon A study lens.
11000544|NCT01055457|BG003|Baseline|Solution 1 (Lotrafilcon A)|All subjects that were dispensed solution 1 and the lotrafilcon A study lens.
11000545|NCT01055457|BG004|Baseline|Solution 1 (Galyfilcon A)|All subjects that were dispensed solution 1 and the galyfilcon A study lens.
11000546|NCT01055457|BG005|Baseline|Solution 2 (Etafilcon A)|All subjects that were dispensed solution 2 and etafilcon A study lens.
11000547|NCT01055457|BG006|Baseline|Solution 2 (Comfilcon A)|All subjects that were dispensed solution 2 and the comfilcon A study lens.
11000548|NCT01055457|BG007|Baseline|Solution 2 (Balafilcon A)|All subjects that were dispensed solution 2 and balafilcon A study lens.
11000549|NCT01055457|BG008|Baseline|Solution 2 (Lotrafilcon A)|All subjects that were dispensed solution 2 and the lotrafilcon A study lens.
11000550|NCT01055457|BG009|Baseline|Solution 2 (Galyfilcon A)|All subjects that were dispensed solution 2 and the galyfilcon A study lens.
11000551|NCT01055457|BG010|Baseline|Total|Total of all reporting groups
11000552|NCT01055457|FG000|Participant Flow|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000553|NCT01055457|FG001|Participant Flow|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000554|NCT01055457|FG002|Participant Flow|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000555|NCT01055457|FG003|Participant Flow|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000556|NCT01055457|FG004|Participant Flow|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000557|NCT01055457|FG005|Participant Flow|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000558|NCT01055457|FG006|Participant Flow|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000559|NCT01055457|FG007|Participant Flow|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000560|NCT01055457|FG008|Participant Flow|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000561|NCT01055457|FG009|Participant Flow|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000562|NCT01055457|OG000|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000563|NCT01055457|OG001|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000564|NCT01055457|OG002|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000565|NCT01055457|OG003|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000566|NCT01055457|OG004|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000567|NCT01055457|OG005|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000568|NCT01055457|OG006|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000569|NCT01055457|OG007|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000570|NCT01055457|OG008|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000571|NCT01055457|OG009|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000572|NCT01055457|EG000|Reported Event|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000573|NCT01055457|EG001|Reported Event|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000574|NCT01055457|EG002|Reported Event|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000575|NCT01055457|EG003|Reported Event|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000576|NCT01055457|EG004|Reported Event|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
11000577|NCT01055457|EG005|Reported Event|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000578|NCT01055457|EG006|Reported Event|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000579|NCT01055457|EG007|Reported Event|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000580|NCT01055457|EG008|Reported Event|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
10845747|NCT00269477|FG001|Participant Flow|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
11000581|NCT01055457|EG009|Reported Event|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
11000582|NCT01055496|BG000|Baseline|Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin|IV inotuzumab ozogamicn (0.8 or 1.3 mg/m^2 on Day 2 of each 21-day cycle) in combination with rituximab (375 mg/m^2) and vincristine (1.4mg/m^2) administererd IV on day 1, prednisone (40mg/m^2) PO on Day 1-5 and cyclophosphamid IV (375, 550 or 750 mg/m^2) on Day 1 of each 21-day cycle (R-CVP) for a maximum of 6 cycles.
11000583|NCT01055496|BG001|Baseline|Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin|IV inotuzumab ozogamicin (0.8 mg/m^2 on Day 2 of each 21-day cycle) in combination with IV Rituximab (375 mg/m^2 on Day 1), dexamethasone (40 mg PO on Days 1 to 4), and escalating doses of IV gemcitabine (500 or 1000 mg/m^2) or IV cisplatinum (0, 37.5, 50 or 75 mg/m^2) on Day 1 of each 21-day cycle (R-GDP) for a maximum of 6 cycles.
11000584|NCT01055496|BG002|Baseline|Total|Total of all reporting groups
11000585|NCT01055496|FG000|Participant Flow|Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin|IV inotuzumab ozogamicn (0.8 or 1.3 mg/m^2 on Day 2 of each 21-day cycle) in combination with rituximab (375 mg/m^2) and vincristine (1.4mg/m^2) administererd IV on day 1, prednisone (40mg/m^2) PO on Day 1-5 and cyclophosphamid IV (375, 550 or 750 mg/m^2) on Day 1 of each 21-day cycle (R-CVP) for a maximum of 6 cycles.
11000586|NCT01055496|FG001|Participant Flow|Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin|IV inotuzumab ozogamicin (0.8 mg/m^2 on Day 2 of each 21-day cycle) in combination with IV Rituximab (375 mg/m^2 on Day 1), dexamethasone (40 mg PO on Days 1 to 4), and escalating doses of IV gemcitabine (500 or 1000 mg/m^2) or IV cisplatinum (0, 37.5, 50 or 75 mg/m^2) on Day 1 of each 21-day cycle (R-GDP) for a maximum of 6 cycles.
11000587|NCT01055496|OG000|Outcome|Cohort 1, Arm 1|Participants in cohort 1 of Arm 1 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in with combination rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) administered IV on Day 1, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV on Day 1 at a dose of 375 mg/m^2.
11000588|NCT01055496|OG001|Outcome|Cohort 2, Arm 1|Participants in cohort 2 of Arm 1 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) administered IV on Day 1, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV on Day 1 at a dose of 550 mg/m^2.
11000589|NCT01055496|OG002|Outcome|Cohort 3, Arm 1|Participants in cohort 3 of Arm 1 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) administered IV on Day 1, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV on Day 1 at a dose of 750 mg/m^2.
11000590|NCT01055496|OG003|Outcome|Cohort 4, Arm 1|Participants in cohort 4 of Arm 1 received inotuzumab ozogamicin (1.3 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) administered IV on Day 1, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV on Day 1 at a dose of 750 mg/m^2.
11000591|NCT01055496|OG004|Outcome|MTD Confirmation Cohort, Arm 1|Participants in the MTD of Arm 1 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) administered IV on Day 1, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV at a dose of 750 mg/m^2.
11000592|NCT01055496|OG000|Outcome|DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin|Participants received inotuzumab ozogamicin (0.8 or 1.3 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with R-CVP. Rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) were administered IV on Day 1, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV at escalating doses of 375, 550, or 750 mg/m^2 on Day 1, of each 21-day cycle for a maximum of 6 cycles, according to a 3+3 DE rule where the doses escalated in a step-by-step fashion to determine the MTD.
11000593|NCT01055496|OG001|Outcome|DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin|Participants received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with R-GDP. Rituximab (375 mg/m^2) was administered IV on Day 1 and dexamethasone (40 mg) PO on Days 1 to 4. Participants received escalating doses of gemcitabine (500 or 1000 mg/m^2) or cisplatinum (0, 37.5, 50 or 75 mg/m^2) and were administered IV on Day 1 of each 21-day cycle, for a maximum of 6 cycles. DE in Arm 2 was conducted using an up-and-down dose escalation method by increasing or decreasing the dose of either cisplatinum or gemcitabine to determine the MTD.
11000594|NCT01055496|OG000|Outcome|Cohort 1, Arm 2|Participants in cohort 1 of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (500 mg/m^2) and cisplatinum (37.5 mg/m^2) administered IV on Day 1 of each 21-day cycle.
11000595|NCT01055496|OG001|Outcome|Cohort 2a, Arm 2|Participants in cohort 2a of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (1000 mg/m^2) and cisplatinum (37.5 mg/m^2) administered IV on Day 1 of each 21-day cycle.
11000596|NCT01055496|OG002|Outcome|Cohort 2b, Arm 2|Participants in cohort 2b of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (500 mg/m^2) and cisplatinum (50 mg/m^2) administered IV on Day 1 of each 21-day cycle.
11000597|NCT01055496|OG003|Outcome|Cohort 3b, Arm 2|Participants in cohort 3b of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (500 mg/m^2) and cisplatinum (75 mg/m^2) administered IV on Day 1 of each 21-day cycle.
11000598|NCT01055496|OG004|Outcome|Cohort 4, Arm 2|Participants in cohort 4 of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (1000 mg/m^2) administered IV on Day 1 of each 21-day cycle.
11000599|NCT01055496|OG005|Outcome|MTD Confirmation Cohort, Arm 2|Participants in the MTD cohort of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2), cisplatinum (50 mg/m^2) and gemcitabine (500 mg/m^2) IV on Day 1, and dexamethasone (40 mg) PO on Days 1 to 4 of each 21-day cycle.
11000600|NCT01055496|OG000|Outcome|MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin|Participants received rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) IV on Day 1, inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 and prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV at 750 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 6 cycles.
11000601|NCT01055496|OG001|Outcome|MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin|Participants received rituximab (375 mg/m^2), cisplatinum (50 mg/m^2) and gemcitabine (500 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles.
11000602|NCT01055496|OG000|Outcome|Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin|IV inotuzumab ozogamicn (0.8 or 1.3 mg/m^2 on Day 2 of each 21-day cycle) in combination with rituximab (375 mg/m^2) and vincristine (1.4mg/m^2) administererd IV on day 1, prednisone (40mg/m^2) PO on Day 1-5 and cyclophosphamid IV (375, 550 or 750 mg/m^2) on Day 1 of each 21-day cycle (R-CVP) for a maximum of 6 cycles.
11000603|NCT01055496|OG001|Outcome|Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin|IV inotuzumab ozogamicin (0.8 mg/m^2 on Day 2 of each 21-day cycle) in combination with IV Rituximab (375 mg/m^2 on Day 1), dexamethasone (40 mg PO on Days 1 to 4), and escalating doses of IV gemcitabine (500 or 1000 mg/m^2) or IV cisplatinum (0, 37.5, 50 or 75 mg/m^2) on Day 1 of each 21-day cycle (R-GDP) for a maximum of 6 cycles.
11000604|NCT01055496|OG000|Outcome|Cohort 4, Arm 1|Participants in cohort 4 of Arm 1 received inotuzumab ozogamicin (1.3 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) administered IV on Day 1, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV on Day 1 at a dose of 750 mg/m^2.
11000605|NCT01055496|OG001|Outcome|Cohort 1, Arm 2|Participants in cohort 1 of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (500 mg/m^2) and cisplatinum (37.5 mg/m^2) administered IV on Day 1 of each 21-day cycle.
11000606|NCT01055496|OG002|Outcome|Cohort 3b, Arm 2|Participants in cohort 3b of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (500 mg/m^2) and cisplatinum (75 mg/m^2) administered IV on Day 1 of each 21-day cycle.
11000607|NCT01055496|OG003|Outcome|Cohort 4, Arm 2|Participants in cohort 4 of Arm 2 received inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles in combination with rituximab (375 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and gemcitabine (1000 mg/m^2) administered IV on Day 1 of each 21-day cycle.
11000608|NCT01055496|OG004|Outcome|Cohort 3/MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin|Participants received rituximab (375 mg/m^2) and vincristine (1.4 mg/m^2) IV on Day 1, inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2, prednisone (40 mg/m^2) PO on Days 1 to 5 and cyclophosphamide IV at 750 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 6 cycles.
11000609|NCT01055496|OG005|Outcome|Cohort 2b/MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin|Participants received rituximab (375 mg/m^2), cisplatinum (50 mg/m^2) and gemcitabine (500 mg/m^2) IV on Day 1, dexamethasone (40 mg) PO on Days 1 to 4, and inotuzumab ozogamicin (0.8 mg/m^2) IV on Day 2 of each 21-day cycle for a maximum of 6 cycles.
11000610|NCT01055496|EG000|Reported Event|Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin|IV inotuzumab ozogamicn (0.8 or 1.3 mg/m^2 on Day 2 of each 21-day cycle) in combination with rituximab (375 mg/m^2) and vincristine (1.4mg/m^2) administererd IV on day 1, prednisone (40mg/m^2) PO on Day 1-5 and cyclophosphamid IV (375, 550 or 750 mg/m^2) on Day 1 of each 21-day cycle (R-CVP) for a maximum of 6 cycles.
11000611|NCT01055496|EG001|Reported Event|Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin|IV inotuzumab ozogamicin (0.8 mg/m^2 on Day 2 of each 21-day cycle) in combination with IV Rituximab (375 mg/m^2 on Day 1), dexamethasone (40 mg PO on Days 1 to 4), and escalating doses of IV gemcitabine (500 or 1000 mg/m^2) or IV cisplatinum (0, 37.5, 50 or 75 mg/m^2) on Day 1 of each 21-day cycle (R-GDP) for a maximum of 6 cycles.
11000612|NCT01055613|BG000|Baseline|Experimental Mutli-purpose Solution|Experimental multi-purpose solution (Test treatment) .
11000613|NCT01055613|BG001|Baseline|ReNu Multi-purpose Solution|Marketed multi-purpose solution (Control Treatment).
11000614|NCT01055613|BG002|Baseline|Total|Total of all reporting groups
11000615|NCT01055613|FG000|Participant Flow|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
11000616|NCT01055613|FG001|Participant Flow|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
11000617|NCT01055613|OG000|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
11000618|NCT01055613|OG001|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
11000619|NCT01055613|EG000|Reported Event|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
11000620|NCT01055613|EG001|Reported Event|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
11000621|NCT01055639|BG000|Baseline|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
11000622|NCT01055639|BG001|Baseline|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
11000623|NCT01055639|BG002|Baseline|Total|Total of all reporting groups
11000624|NCT01055639|FG000|Participant Flow|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
11007696|NCT01092442|EG000|Reported Event|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
11000625|NCT01055639|FG001|Participant Flow|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
11000626|NCT01055639|OG000|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
11000627|NCT01055639|OG001|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
11000628|NCT01055639|EG000|Reported Event|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
11000629|NCT01055639|EG001|Reported Event|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
11000630|NCT01055704|BG000|Baseline|Methylnaltrexone 0.30 mg/kg|
11000631|NCT01055704|BG001|Baseline|Codeine 30 mg|
11000632|NCT01055704|BG002|Baseline|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
11000633|NCT01055704|BG003|Baseline|Placebo|
11000634|NCT01055704|BG004|Baseline|Total|Total of all reporting groups
11000635|NCT01055704|FG000|Participant Flow|Methylnaltrexone 0.30 mg/kg|
11000636|NCT01055704|FG001|Participant Flow|Codeine 30 mg|
11000637|NCT01055704|FG002|Participant Flow|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
11000638|NCT01055704|FG003|Participant Flow|Placebo|
10845748|NCT00269477|FG002|Participant Flow|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
11000639|NCT01055704|OG000|Outcome|Methylnaltrexone 0.30 mg/kg|
11000640|NCT01055704|OG001|Outcome|Codeine 30 mg|
11000641|NCT01055704|OG002|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
11000642|NCT01055704|OG003|Outcome|Placebo|
11000643|NCT01055704|EG000|Reported Event|Methylnaltrexone 0.30 mg/kg|
11000644|NCT01055704|EG001|Reported Event|Codeine 30 mg|
11000645|NCT01055704|EG002|Reported Event|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
11000646|NCT01055704|EG003|Reported Event|Placebo|
11000647|NCT01055769|BG000|Baseline|Linezolid|Linezolid 600 mg once (oral suspension or tablet) in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
11000648|NCT01055769|FG000|Participant Flow|Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
11000649|NCT01055769|FG001|Participant Flow|Linezolid 600 mg Tablet, Then Linezolid 600 mg Oral Suspension|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
11000650|NCT01055769|OG000|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
11000651|NCT01055769|OG001|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
11000652|NCT01055769|OG001|Outcome|Linezolid 600mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
11000653|NCT01055769|EG000|Reported Event|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
11000654|NCT01055769|EG001|Reported Event|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
11000655|NCT01055782|BG000|Baseline|With Endoguide|Colonoscopy completed with endoguide
11000656|NCT01055782|BG001|Baseline|Without Endoguide|Colonoscopy completed without endoguide
11000657|NCT01055782|BG002|Baseline|Total|Total of all reporting groups
11000658|NCT01055782|FG000|Participant Flow|With Endoguide|Colonoscopy completed with endoguide
11000659|NCT01055782|FG001|Participant Flow|Without Endoguide|Colonoscopy completed without endoguide
11000660|NCT01055782|OG000|Outcome|With Endoguide - Success Rate|Exams completed with endoguide. Success rate/completion.
11000661|NCT01055782|OG001|Outcome|Without Endoguide|Exams completed without endoguide. Success rate/completion.
11000662|NCT01055782|OG000|Outcome|With Endoguide|Colonoscopy completed with endoguide
11000663|NCT01055782|OG001|Outcome|Without Endoguide|Colonoscopy completed without endoguide
11000664|NCT01055782|EG000|Reported Event|With Endoguide|Colonoscopy completed with endoguide
11000665|NCT01055782|EG001|Reported Event|Without Endoguide|Colonoscopy completed without endoguide
11000666|NCT01055834|BG000|Baseline|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II. At least a 5 day period passed before post treatment examinations.
11000667|NCT01055834|BG001|Baseline|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone one 3 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II.~After Period II there was at least a 5 day washout period. Certain participants from Group B only proceeded to Period III where they received Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast for 3 days. At least a 5 day period passed before post treatment examinations."
11000668|NCT01055834|BG002|Baseline|Total|Total of all reporting groups
11000669|NCT01055834|FG000|Participant Flow|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received a single dose of Eszopiclone one 3 mg tablet administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in Period II. At least a 5 day period passed before post treatment examinations.
11000670|NCT01055834|FG001|Participant Flow|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received a single dose of Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone one 3 mg tablet with water in the morning after fasting for 10 or more hours in Period II.~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations."
11000671|NCT01055834|OG000|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:~Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
11000672|NCT01055834|OG001|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:~Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
11000673|NCT01055834|OG000|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.~Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
11000674|NCT01055834|EG000|Reported Event|Eszopiclone One 3 mg Tablet|Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
11000675|NCT01055834|EG001|Reported Event|Eszopiclone Three 1 mg Tablets|Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
11000676|NCT01055834|EG002|Reported Event|Eszopiclone One 3 mg Tablet (Fed)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fed conditions.
11000677|NCT01055834|EG003|Reported Event|Eszopiclone One 3 mg Tablet (Fasted)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fasted conditions.
11000678|NCT01055886|BG000|Baseline|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
11000679|NCT01055886|BG001|Baseline|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
10845749|NCT00269477|FG003|Participant Flow|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
11000680|NCT01055886|BG002|Baseline|Total|Total of all reporting groups
11000681|NCT01055886|FG000|Participant Flow|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
11000682|NCT01055886|FG001|Participant Flow|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
11000683|NCT01055886|OG000|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
11000684|NCT01055886|OG001|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
11000685|NCT01055886|EG000|Reported Event|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
11000686|NCT01055886|EG001|Reported Event|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
11007697|NCT01092442|EG001|Reported Event|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
11007698|NCT01092507|BG000|Baseline|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
11007699|NCT01092507|BG001|Baseline|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
11007700|NCT01092507|BG002|Baseline|Total|Total of all reporting groups
11007701|NCT01092507|FG000|Participant Flow|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
11007702|NCT01092507|FG001|Participant Flow|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
11007703|NCT01092507|OG000|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
11007704|NCT01092507|OG001|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
11007705|NCT01092507|EG000|Reported Event|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
11007706|NCT01092507|EG001|Reported Event|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
11336490|NCT03567005|FG001|Participant Flow|DACP Then DACP Digital|Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.
10846628|NCT00278629|BG000|Baseline|Hematopoietic Stem Cell Transplantation for CIDP|Autologous hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide 200 mg/kg/intravenously(IV), rATG(thymoglobulin) 5.5 mg/kg/IV and rituximab 1000mg/IV.
11007707|NCT01092546|BG000|Baseline|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
11007708|NCT01092546|FG000|Participant Flow|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
11007709|NCT01092546|OG000|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
11007710|NCT01092546|EG000|Reported Event|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
11007711|NCT01092559|BG000|Baseline|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide via GeNO Nitrosyl System
11007712|NCT01092559|FG000|Participant Flow|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
11007713|NCT01092559|OG000|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
11007714|NCT01092559|EG000|Reported Event|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
11007715|NCT01092637|BG000|Baseline|Cooled|Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth
11007716|NCT01092637|BG001|Baseline|Non-cooled|Child was allocated standard intensive care only within 6 hours of birth
11007717|NCT01092637|BG002|Baseline|Total|Total of all reporting groups
11007718|NCT01092637|FG000|Participant Flow|Cooled|"Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth. Cooling lasted for 72 hours then gradually rewarmed, after which normothermia was maintained.~Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.~Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.~Psychologist completed the following tests:~Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)~NEPSY II selected sub-tests~Working Memory Test Battery for Children (WMTB-C)~Assessors were blinded to original trial treatment allocation."
11000687|NCT01056016|BG000|Baseline|Wait-list Control|Wait-list control group
11000688|NCT01056016|BG001|Baseline|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
11000689|NCT01056016|BG002|Baseline|Total|Total of all reporting groups
11000690|NCT01056016|FG000|Participant Flow|Wait-list Control|Wait-list control group
11000691|NCT01056016|FG001|Participant Flow|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to American Academy of Pediatrics (AAP) ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics include the importance of obtaining parent and teacher behavioral ratings at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
11000692|NCT01056016|OG000|Outcome|Wait-list Control|Wait-list control group
11000693|NCT01056016|OG001|Outcome|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
11000694|NCT01056016|EG000|Reported Event|Wait-list Control|Wait-list control group
11000695|NCT01056016|EG001|Reported Event|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
11000696|NCT01056107|BG000|Baseline|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000697|NCT01056107|BG001|Baseline|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000698|NCT01056107|BG002|Baseline|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000699|NCT01056107|BG003|Baseline|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000700|NCT01056107|BG004|Baseline|Total|Total of all reporting groups
11000701|NCT01056107|FG000|Participant Flow|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000702|NCT01056107|FG001|Participant Flow|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000703|NCT01056107|FG002|Participant Flow|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000704|NCT01056107|FG003|Participant Flow|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000705|NCT01056107|OG000|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000706|NCT01056107|OG001|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000707|NCT01056107|OG002|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000708|NCT01056107|OG003|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000709|NCT01056107|EG000|Reported Event|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000710|NCT01056107|EG001|Reported Event|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000711|NCT01056107|EG002|Reported Event|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000712|NCT01056107|EG003|Reported Event|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
11000713|NCT01056198|BG000|Baseline|Santyl|2 mm Santyl once daily (QD)
11000714|NCT01056198|BG001|Baseline|Control|Daily gauze and optional sharp debridement
11000715|NCT01056198|BG002|Baseline|Total|Total of all reporting groups
11000716|NCT01056198|FG000|Participant Flow|Santyl|2 mm Santyl once daily (QD)
11000717|NCT01056198|FG001|Participant Flow|Control|Daily gauze and optional sharp debridement
11000718|NCT01056198|OG000|Outcome|Santyl|2 mm Santyl once daily (QD)
11000719|NCT01056198|OG001|Outcome|Control|Daily gauze and optional sharp debridement
11000720|NCT01056198|OG000|Outcome|Santyl|2 mm Santyl QD
11000721|NCT01056198|OG000|Outcome|Control|Daily gauze and optional sharp debridement
11000722|NCT01056198|EG000|Reported Event|Santyl|2 mm Santyl once daily (QD)
11000723|NCT01056198|EG001|Reported Event|Control|Daily gauze and optional sharp debridement
11000724|NCT01056263|BG000|Baseline|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
11000725|NCT01056263|FG000|Participant Flow|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
11000726|NCT01056263|OG000|Outcome|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
11000727|NCT01056263|EG000|Reported Event|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
11000728|NCT01056276|BG000|Baseline|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
11000729|NCT01056276|BG001|Baseline|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
11000730|NCT01056276|BG002|Baseline|Total|Total of all reporting groups
11000731|NCT01056276|FG000|Participant Flow|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
11000732|NCT01056276|FG001|Participant Flow|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
11000733|NCT01056276|OG000|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
11000734|NCT01056276|OG001|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
11000735|NCT01056276|OG000|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
11000736|NCT01056276|OG001|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
11000737|NCT01056276|OG001|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
11000738|NCT01056276|OG001|Outcome|BBD Treatment|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
11000739|NCT01056276|OG000|Outcome|Originl BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
11000740|NCT01056276|EG000|Reported Event|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
11000741|NCT01056276|EG001|Reported Event|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
11000742|NCT01056289|BG000|Baseline|Entire Study Population|24 Week Open-label phase DVS SR 50 mg PO QD followed by 4 Week Double-blind phase: DVS SR 50 mg (reference group), DVS SR 25 mg (taper group), or Placebo (abrupt-discontinuation group).
11000743|NCT01056289|FG000|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks.
11000744|NCT01056289|FG001|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
11000745|NCT01056289|FG002|Participant Flow|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
11000746|NCT01056289|FG003|Participant Flow|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
11000747|NCT01056289|OG000|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
11000748|NCT01056289|OG001|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
11000749|NCT01056289|OG002|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
11000750|NCT01056289|OG001|Outcome|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
11000751|NCT01056289|EG000|Reported Event|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 24 Weeks.
11000752|NCT01056289|EG001|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
11000753|NCT01056289|EG002|Reported Event|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
11000754|NCT01056289|EG003|Reported Event|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
11224010|NCT02357394|BG000|Baseline|Device: Arabin Pessary|"Participants randomized to this group will receive the pessary.~Arabin Pessary: Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team."
11224011|NCT02357394|BG001|Baseline|Standard of Care|Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.
11000755|NCT01056302|BG000|Baseline|Group 1|"3 patients with maxillofacial trauma who underwent surgical repair at San Francisco VA Medical Center~Surgical repair of maxillofacial trauma: Patients will undergo whatever needed surgical repair of maxillofacial trauma that is necessary. Records such as CT imaging and plaster models of the jaws will be utilized in the standard way to plan and carry out the surgery. The CT scan will also be used within the visuohaptic computational environment to develop and evaluate the user interface. The amount of time taken to work up and plan surgery using standard surgical practice and using the computational platform will be compared. Real surgical outcome will be compared to the simulated outcome using the proposed software tool."
11000756|NCT01056302|FG000|Participant Flow|Group 1|"3 patients with maxillofacial trauma who underwent surgical repair at San Francisco VA Medical Center~Surgical repair of maxillofacial trauma: Patients will undergo whatever needed surgical repair of maxillofacial trauma that is necessary. Records such as CT imaging and plaster models of the jaws will be utilized in the standard way to plan and carry out the surgery. The CT scan will also be used within the visuohaptic computational environment to develop and evaluate the user interface. The amount of time taken to work up and plan surgery using standard surgical practice and using the computational platform will be compared. Real surgical outcome will be compared to the simulated outcome using the proposed software tool."
11000757|NCT01056302|OG000|Outcome|Group 1|"3 patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center~Patients underwent surgical repair of their mandibular fracture(s) in the usual and customary way. Preoperative CT imaging was utilized by the surgeon to plan and carry out the surgery. Following surgery, a postoperative CT scan was done to assess the success of the surgery to accurately reposition all the fractured bone. Each patient's preoperative CT scan was also used within the visuohaptic computational environment to develop and evaluate the user interface. Once the software was deemed suitable for use, it was tested. The test consisted of measuring the accuracy of the virtual surgical repair compared to the real surgical outcome, as seen on the postoperative CT scan."
11000758|NCT01056302|OG000|Outcome|Group 1|"Patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center~Patients underwent surgical repair of their mandibular fracture(s) in the usual and customary way. Preoperative CT imaging was utilized by the surgeon to plan and carry out the surgery. Following surgery, a postoperative CT scan was done to assess the success of the surgery to accurately reposition all the fractured bone. Each patient's preoperative CT scan was also used within the visuohaptic computational environment to develop and evaluate the user interface. Once the software was deemed suitable for use, it was tested. The test consisted of measuring the accuracy of the virtual surgical repair compared to the real surgical outcome, as seen on the postoperative CT scan."
11000759|NCT01056302|EG000|Reported Event|Group 1|"3 patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center~Surgical repair of mandibular fracture(s): Patients will undergo whatever needed surgical repair of mandibular fracture(s) that is necessary. Records such as CT imaging were utilized in the standard way to plan and carry out the surgery. The CT scan was also used within the visuohaptic computational environment to develop and evaluate the user interface."
11000760|NCT01056328|BG000|Baseline|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
11000761|NCT01056328|BG001|Baseline|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
11000762|NCT01056328|BG002|Baseline|Total|Total of all reporting groups
11000763|NCT01056328|FG000|Participant Flow|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
11000764|NCT01056328|FG001|Participant Flow|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
11000765|NCT01056328|OG000|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
11000766|NCT01056328|OG001|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
11000767|NCT01056328|OG000|Outcome|St Jude Medical (SJM) Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
11000768|NCT01056328|OG001|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated Radio Frequency (RF) Ablation System: Irrigated ablation catheter
11000769|NCT01056328|OG001|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
11000770|NCT01056328|EG000|Reported Event|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
11000771|NCT01056328|EG001|Reported Event|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
11000772|NCT01056341|BG000|Baseline|Placebo|Placebo: Treatment with placebo for 6 months
11000773|NCT01056341|BG001|Baseline|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
11000774|NCT01056341|BG002|Baseline|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
11000775|NCT01056341|BG003|Baseline|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
11000776|NCT01056341|BG004|Baseline|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
11000777|NCT01056341|BG005|Baseline|Total|Total of all reporting groups
11000778|NCT01056341|FG000|Participant Flow|Placebo|Placebo: Treatment with placebo for 6 months
11000779|NCT01056341|FG001|Participant Flow|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
11000780|NCT01056341|FG002|Participant Flow|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
11000781|NCT01056341|FG003|Participant Flow|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
11000782|NCT01056341|FG004|Participant Flow|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
11000783|NCT01056341|OG000|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
11000784|NCT01056341|OG001|Outcome|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
11000785|NCT01056341|OG002|Outcome|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
11000786|NCT01056341|OG003|Outcome|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
11000787|NCT01056341|OG004|Outcome|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
11000788|NCT01056341|OG001|Outcome|Propranolol 3mg/kg/d 6 Months|Propranolol 3 mg/kg/day for 6 months
11000789|NCT01056341|EG000|Reported Event|W24-treatment Period-safety Set-Placebo|Placebo: Treatment with placebo for 6 months
11000790|NCT01056341|EG001|Reported Event|W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 3 months, then placebo for 3 months
11000791|NCT01056341|EG002|Reported Event|W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 6 months
11000792|NCT01056341|EG003|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 3 months, then placebo for 3 months
11000793|NCT01056341|EG004|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 6 months
11000794|NCT01056341|EG005|Reported Event|W72-follow-up Period of ex Placebo Group-safety Set|72-week follow-up period without study treatment administration
11000795|NCT01056341|EG006|Reported Event|W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
11000796|NCT01056341|EG007|Reported Event|W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
11000797|NCT01056341|EG008|Reported Event|W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
11000798|NCT01056341|EG009|Reported Event|W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
11000799|NCT01056380|BG000|Baseline|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
11000800|NCT01056380|BG001|Baseline|Placebo|Placebo : Tablet, twice daily with food for 5 days
11000801|NCT01056380|BG002|Baseline|Total|Total of all reporting groups
11000802|NCT01056380|FG000|Participant Flow|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
11000803|NCT01056380|FG001|Participant Flow|Placebo|Placebo : Tablet, twice daily with food for 5 days
11000804|NCT01056380|OG000|Outcome|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
11000805|NCT01056380|OG001|Outcome|Placebo|Placebo : Tablet, twice daily with food for 5 days
11000806|NCT01056380|OG000|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
11000807|NCT01056380|OG001|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
11000808|NCT01056380|EG000|Reported Event|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
11000809|NCT01056380|EG001|Reported Event|Placebo|Placebo : Tablet, twice daily with food for 5 days
11000810|NCT01056484|BG000|Baseline|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
11000811|NCT01056484|BG001|Baseline|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
11000812|NCT01056484|BG002|Baseline|Total|Total of all reporting groups
11000813|NCT01056484|FG000|Participant Flow|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
11000814|NCT01056484|FG001|Participant Flow|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
11000815|NCT01056484|OG000|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
11000816|NCT01056484|OG001|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
11000817|NCT01056484|OG000|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
11000818|NCT01056484|EG000|Reported Event|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
11000819|NCT01056484|EG001|Reported Event|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
11000820|NCT01056510|BG000|Baseline|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
11000821|NCT01056510|BG001|Baseline|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
11000822|NCT01056510|BG002|Baseline|Total|Total of all reporting groups
11000823|NCT01056510|FG000|Participant Flow|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received intravenous (IV) rituximab 375 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced progressive disease (PD).
11000824|NCT01056510|FG001|Participant Flow|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally (PO) at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until complete response (CR) was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
11000825|NCT01056510|OG000|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
11000826|NCT01056510|OG001|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
11000827|NCT01056510|EG000|Reported Event|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
11000828|NCT01056510|EG001|Reported Event|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
10845750|NCT00269477|OG000|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
11000829|NCT01056523|BG000|Baseline|Ribavirin and Cytarabine|Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID Drug: Cytarabine arabinoside Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.
11000830|NCT01056523|FG000|Participant Flow|Dose Level 1|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
11000831|NCT01056523|FG001|Participant Flow|Dose Level 2|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
11000832|NCT01056523|FG002|Participant Flow|Dose Level 3|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
11000833|NCT01056523|FG003|Participant Flow|Dose Level 4|Ribavirin 2200 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
11000834|NCT01056523|FG004|Participant Flow|Dose Level 5|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
11000835|NCT01056523|FG005|Participant Flow|Dose Level 6|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
11000836|NCT01056523|FG006|Participant Flow|Dose Level 7|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
11000837|NCT01056523|OG000|Outcome|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID~Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.~Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
11000838|NCT01056523|OG000|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
11000839|NCT01056523|EG000|Reported Event|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID~Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.~Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
11000840|NCT01056536|BG000|Baseline|Structured Intervention + Free Condoms|"The subjects will receive a structured intervention on STI's and will be offered free condoms~Structured intervention for the prevention of sexually transmitted infections (STI): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms."
11000841|NCT01056536|BG001|Baseline|Free Condoms|"Subjects will be offered free condoms at the end of the pre-travel consultation~Structured intervention for the prevention of sexually transmitted infections (STI): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms."
11000842|NCT01056536|BG002|Baseline|No Intervention|The topic of STI's will not be actively discussed during the pretravel consultation
11000843|NCT01056536|BG003|Baseline|Total|Total of all reporting groups
11000844|NCT01056536|FG000|Participant Flow|Structured Intervention + Free Condoms|"The subjects will receive a structured intervention on STI's and will be offered free condoms~Structured intervention for the prevention of sexually transmitted infections (STI): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms."
11000845|NCT01056536|FG001|Participant Flow|Free Condoms|"Subjects will be offered free condoms at the end of the pre-travel consultation~Structured intervention for the prevention of sexually transmitted infections (STI): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms."
11000846|NCT01056536|FG002|Participant Flow|No Intervention|The topic of STI's will not be actively discussed during the pretravel consultation
11000847|NCT01056536|OG000|Outcome|Structured Intervention + Free Condoms|"The subjects will receive a structured intervention on STI's and will be offered free condoms~Structured intervention for the prevention of sexually transmitted infections (STI): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms."
11000848|NCT01056536|OG001|Outcome|Free Condoms|"Subjects will be offered free condoms at the end of the pre-travel consultation~Structured intervention for the prevention of sexually transmitted infections (STI): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms."
11000849|NCT01056536|OG002|Outcome|No Intervention|The topic of STI's will not be actively discussed during the pretravel consultation
11000850|NCT01056536|EG000|Reported Event|Structured Intervention + Free Condoms|"The subjects will receive a structured intervention on STI's and will be offered free condoms~Structured intervention for the prevention of sexually transmitted infections (STI): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms."
11000851|NCT01056536|EG001|Reported Event|Free Condoms|"Subjects will be offered free condoms at the end of the pre-travel consultation~Structured intervention for the prevention of sexually transmitted infections (STI): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms."
11000852|NCT01056536|EG002|Reported Event|No Intervention|The topic of STI's will not be actively discussed during the pretravel consultation
11000853|NCT01056601|BG000|Baseline|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
11224012|NCT02357394|BG002|Baseline|Total|Total of all reporting groups
11000854|NCT01056601|FG000|Participant Flow|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
11000855|NCT01056601|OG000|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
11000856|NCT01056601|EG000|Reported Event|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
11000857|NCT01056640|BG000|Baseline|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
11000858|NCT01056640|BG001|Baseline|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
11000859|NCT01056640|BG002|Baseline|Total|Total of all reporting groups
11000860|NCT01056640|FG000|Participant Flow|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
11000861|NCT01056640|FG001|Participant Flow|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
11000862|NCT01056640|OG000|Outcome|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
11000863|NCT01056640|OG001|Outcome|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
11000864|NCT01056640|EG000|Reported Event|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
11000865|NCT01056640|EG001|Reported Event|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
11000866|NCT01056653|BG000|Baseline|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
11000867|NCT01056653|BG001|Baseline|Group B Purple|"Four home visits~High Dose: Four home visits"
10845751|NCT00269477|OG001|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
11000868|NCT01056653|BG002|Baseline|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
11000869|NCT01056653|BG003|Baseline|Total|Total of all reporting groups
11000870|NCT01056653|FG000|Participant Flow|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits (at 4 and 6 months of age)"
11000871|NCT01056653|FG001|Participant Flow|Group B Purple|"Four home visits~High Dose: Four home visits (at 4, 5, 6, and 7 months of age)"
11000872|NCT01056653|FG002|Participant Flow|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only (at 4 months of age)"
11000873|NCT01056653|OG000|Outcome|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
11000874|NCT01056653|OG001|Outcome|Group B Purple|"Four intervention home visits~High Dose: Four home visits"
11000875|NCT01056653|OG002|Outcome|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
11000876|NCT01056653|OG001|Outcome|Group B Purple|"Four home visits~High Dose: Four home visits"
11000877|NCT01056653|EG000|Reported Event|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
11000878|NCT01056653|EG001|Reported Event|Group B Purple|"Four home visits~High Dose: Four home visits"
10845752|NCT00269477|OG002|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
11000879|NCT01056653|EG002|Reported Event|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
11000880|NCT01056718|BG000|Baseline|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
11000881|NCT01056718|FG000|Participant Flow|Nebivolol Treatment|10 week open label nebivolol treatment.
11000882|NCT01056718|OG000|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
11000883|NCT01056718|OG000|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
11000884|NCT01056718|EG000|Reported Event|Starting on 5 mg of Nebivolol Then Titrated|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
11000885|NCT01056822|BG000|Baseline|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
11000886|NCT01056822|BG001|Baseline|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
11000887|NCT01056822|BG002|Baseline|Total|Total of all reporting groups
11000888|NCT01056822|FG000|Participant Flow|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
11000889|NCT01056822|FG001|Participant Flow|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
11000890|NCT01056822|OG000|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
11000891|NCT01056822|OG001|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
11000892|NCT01056822|OG000|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
11000893|NCT01056822|EG000|Reported Event|Micofenolato Sodium|Micofenolato sodium
11000894|NCT01056822|EG001|Reported Event|Micofenolato Mofetilo|Micofenolato mofetilo
11000895|NCT01056913|BG000|Baseline|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
11000896|NCT01056913|FG000|Participant Flow|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
11000897|NCT01056913|OG000|Outcome|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
11000898|NCT01056913|EG000|Reported Event|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
11000899|NCT01057017|BG000|Baseline|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
11000900|NCT01057017|FG000|Participant Flow|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
11000901|NCT01057017|OG000|Outcome|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
11000902|NCT01057017|EG000|Reported Event|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
11000903|NCT01057225|BG000|Baseline|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
11000904|NCT01057225|FG000|Participant Flow|Phase I: Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000905|NCT01057225|FG001|Participant Flow|Phase I: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000906|NCT01057225|FG002|Participant Flow|Phase I: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
10846629|NCT00278629|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|Autologous hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide 200 mg/kg/intravenously(IV), rATG(thymoglobulin) 5.5 mg/kg/IV and rituximab 1000mg/IV.
11000907|NCT01057225|FG003|Participant Flow|Phase I: Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000908|NCT01057225|FG004|Participant Flow|Phase II: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000909|NCT01057225|FG005|Participant Flow|Phase II: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000910|NCT01057225|OG000|Outcome|Phase I: Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000911|NCT01057225|OG001|Outcome|Phase I: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000912|NCT01057225|OG002|Outcome|Phase I: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000913|NCT01057225|OG003|Outcome|Phase I: Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000914|NCT01057225|OG000|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
11000915|NCT01057225|OG000|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
11336491|NCT03567005|OG000|Outcome|DACP Digital|Nelfilcon A digital contact lenses worn bilaterally for 7 days in a daily disposable modality.
11000916|NCT01057225|OG000|Outcome|Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000917|NCT01057225|OG001|Outcome|Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000918|NCT01057225|OG002|Outcome|Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000919|NCT01057225|OG003|Outcome|Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
11000920|NCT01057225|EG000|Reported Event|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
11000921|NCT01057251|BG000|Baseline|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
11000922|NCT01057251|BG001|Baseline|Placebo|Dose-matched placebo, once daily oral administration
11000923|NCT01057251|BG002|Baseline|Total|Total of all reporting groups
11000924|NCT01057251|FG000|Participant Flow|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
11000925|NCT01057251|FG001|Participant Flow|Placebo|Dose-matched placebo, once daily oral administration
11000926|NCT01057251|OG000|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
11000927|NCT01057251|OG001|Outcome|Placebo|Dose-matched placebo, once daily oral administration
11000928|NCT01057251|EG000|Reported Event|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
11000929|NCT01057251|EG001|Reported Event|Placebo|Dose-matched placebo, once daily oral administration
11000930|NCT01057277|BG000|Baseline|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
11000931|NCT01057277|FG000|Participant Flow|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
11000932|NCT01057277|OG000|Outcome|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
11000933|NCT01057277|EG000|Reported Event|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
11000934|NCT01057381|BG000|Baseline|Dexmedetomidine 0.75 mcg/kg|"Intraoperative administration for analgesia.~Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia."
11000935|NCT01057381|BG001|Baseline|Dexmedetomidine 1mcg/kg|"Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia~Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia"
11000936|NCT01057381|BG002|Baseline|Morphine 50 mcg/kg|"Intra-operative administration of morphine 50 mcg/kg for analgesia~Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia"
10845753|NCT00269477|OG003|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
11000937|NCT01057381|BG003|Baseline|Morphine 100mcg/kg|"Intra-operative administration of morphine 100mcg/kg for analgesia~Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia"
11000938|NCT01057381|BG004|Baseline|Total|Total of all reporting groups
11000939|NCT01057381|FG000|Participant Flow|Dexmedetomidine 0.75 mcg/kg|"Intraoperative administration for analgesia.~Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia."
11000940|NCT01057381|FG001|Participant Flow|Dexmedetomidine 1mcg/kg|"Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia~Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia"
11000941|NCT01057381|FG002|Participant Flow|Morphine 50 mcg/kg|"Intra-operative administration of morphine 50 mcg/kg for analgesia~Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia"
11000942|NCT01057381|FG003|Participant Flow|Morphine 100mcg/kg|"Intra-operative administration of morphine 100mcg/kg for analgesia~Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia"
11000943|NCT01057381|OG000|Outcome|Dexmedetomidine 0.75 mcg/kg|"Intraoperative administration for analgesia.~Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia."
11000944|NCT01057381|OG001|Outcome|Dexmedetomidine 1mcg/kg|"Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia~Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia"
11000945|NCT01057381|OG002|Outcome|Morphine 50 mcg/kg|"Intra-operative administration of morphine 50 mcg/kg for analgesia~Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia"
11000946|NCT01057381|OG003|Outcome|Morphine 100mcg/kg|"Intra-operative administration of morphine 100mcg/kg for analgesia~Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia"
11000947|NCT01057381|EG000|Reported Event|Dexmedetomidine 0.75 mcg/kg|"Intraoperative administration for analgesia.~Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia."
11000948|NCT01057381|EG001|Reported Event|Dexmedetomidine 1mcg/kg|"Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia~Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia"
11000949|NCT01057381|EG002|Reported Event|Morphine 50 mcg/kg|"Intra-operative administration of morphine 50 mcg/kg for analgesia~Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia"
11000950|NCT01057381|EG003|Reported Event|Morphine 100mcg/kg|"Intra-operative administration of morphine 100mcg/kg for analgesia~Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia"
11000951|NCT01057394|BG000|Baseline|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
11000952|NCT01057394|FG000|Participant Flow|Radiofrequency Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
11000953|NCT01057394|FG001|Participant Flow|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
11000954|NCT01057394|OG000|Outcome|Number of Chronically Isolated Pulmonary Veins|
11000955|NCT01057394|EG000|Reported Event|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
11000956|NCT01057433|BG000|Baseline|All Subjects|
11000957|NCT01057433|FG000|Participant Flow|All Subjects|
11000958|NCT01057433|OG000|Outcome|All Subjects|
11000959|NCT01057433|EG000|Reported Event|All Subjects|
11000960|NCT01057589|BG000|Baseline|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
11000961|NCT01057589|FG000|Participant Flow|Pemetrexed + Cisplatin + Cetuximab|"Pemetrexed 500 milligram per meter squared (mg/m^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles.~At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months.~Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements."
11000962|NCT01057589|OG000|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
11000963|NCT01057589|EG000|Reported Event|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
11000964|NCT01057693|BG000|Baseline|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
11000965|NCT01057693|FG000|Participant Flow|Pregabalin SB|Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase.
11000966|NCT01057693|FG001|Participant Flow|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
11000967|NCT01057693|FG002|Participant Flow|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
11000968|NCT01057693|OG000|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
11000969|NCT01057693|OG001|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
11336492|NCT03567005|OG001|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally for 7 days in a daily disposable modality.
11336493|NCT03567005|EG000|Reported Event|DACP Digital|All subjects exposed to nelfilcon A digital contact lenses
11000970|NCT01057693|OG000|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
11000971|NCT01057693|EG000|Reported Event|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
11000972|NCT01057693|EG001|Reported Event|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
11000973|NCT01057693|EG002|Reported Event|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
11000974|NCT01057810|BG000|Baseline|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
11000975|NCT01057810|BG001|Baseline|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
11000976|NCT01057810|BG002|Baseline|Total|Total of all reporting groups
11000977|NCT01057810|FG000|Participant Flow|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
11000978|NCT01057810|FG001|Participant Flow|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
11000979|NCT01057810|OG000|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
11000980|NCT01057810|OG001|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
11000981|NCT01057810|EG000|Reported Event|PLACEBO|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
11000982|NCT01057810|EG001|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
11000983|NCT01057862|BG000|Baseline|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
11000984|NCT01057862|BG001|Baseline|Placebo|Placebo
11000985|NCT01057862|BG002|Baseline|Total|Total of all reporting groups
11000986|NCT01057862|FG000|Participant Flow|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
11000987|NCT01057862|FG001|Participant Flow|Placebo|
11000988|NCT01057862|OG000|Outcome|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
11000989|NCT01057862|OG001|Outcome|Placebo|Placebo
11000990|NCT01057862|EG000|Reported Event|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
11000991|NCT01057862|EG001|Reported Event|Placebo|Placebo
11000992|NCT01057888|BG000|Baseline|Autodialer|"Autodialer reminder/recall~Autodialer : Autodialer telephone calls"
11000993|NCT01057888|BG001|Baseline|Controls|"Controls~Received standard of care provided by practice"
11000994|NCT01057888|BG002|Baseline|Letters|"Mailed reminder letters~Letters : Mailed reminder letters"
11000995|NCT01057888|BG003|Baseline|Total|Total of all reporting groups
11000996|NCT01057888|FG000|Participant Flow|Autodialer|"Autodialer reminder/recall~Autodialer : Autodialer telephone calls"
11000997|NCT01057888|FG001|Participant Flow|Controls|"Controls~Received standard of care provided by practice"
11000998|NCT01057888|FG002|Participant Flow|Letters|"Mailed reminder letters~Letters : Mailed reminder letters"
11000999|NCT01057888|OG000|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
11001000|NCT01057888|OG001|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
11001001|NCT01057888|OG002|Outcome|Control|Received no reminders from the managed care organization.
11001002|NCT01057888|EG000|Reported Event|Mailed Reminders and Letter Reminders|
11001003|NCT01057901|BG000|Baseline|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
11001004|NCT01057901|BG001|Baseline|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
11001005|NCT01057901|BG002|Baseline|Total|Total of all reporting groups
11336494|NCT03567005|EG001|Reported Event|DACP|All subjects exposed to nelfilcon A contact lenses
11001006|NCT01057901|FG000|Participant Flow|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
11001007|NCT01057901|FG001|Participant Flow|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
11001008|NCT01057901|OG000|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
11001009|NCT01057901|OG001|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
11001010|NCT01057901|EG000|Reported Event|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
11001011|NCT01057901|EG001|Reported Event|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
11001012|NCT01058005|BG000|Baseline|Natalizumab|300 mg intravenous injection every 4 weeks
11001013|NCT01058005|BG001|Baseline|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
11001014|NCT01058005|BG002|Baseline|Glatiramer Acetate|20 mg subcutaneous injection once daily
11224013|NCT02357394|FG000|Participant Flow|Device: Arabin Pessary|"Participants randomized to this group will receive the pessary.~Arabin Pessary: Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team."
11224014|NCT02357394|FG001|Participant Flow|Standard of Care|Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.
11001015|NCT01058005|BG003|Baseline|Total|Total of all reporting groups
11001016|NCT01058005|FG000|Participant Flow|Natalizumab|300 mg intravenous injection every 4 weeks
11001017|NCT01058005|FG001|Participant Flow|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
11001018|NCT01058005|FG002|Participant Flow|Glatiramer Acetate|20 mg subcutaneous injection once daily
11001019|NCT01058005|OG000|Outcome|Natalizumab|300 mg intravenous injection every 4 weeks
11001020|NCT01058005|OG001|Outcome|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
11001021|NCT01058005|OG002|Outcome|Glatiramer Acetate|20 mg subcutaneous injection once daily
11001022|NCT01058005|EG000|Reported Event|Natalizumab|300 mg intravenous injection every 4 weeks
11001023|NCT01058005|EG001|Reported Event|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
11001024|NCT01058005|EG002|Reported Event|Glatiramer Acetate|20 mg subcutaneous injection once daily
11001025|NCT01058070|BG000|Baseline|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
11001026|NCT01058070|FG000|Participant Flow|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
11001027|NCT01058070|OG000|Outcome|LINX Study Subjects|Subjects implanted with LINX device
11001028|NCT01058070|OG000|Outcome|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
11001029|NCT01058070|EG000|Reported Event|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
11001030|NCT01058096|BG000|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
11001031|NCT01058096|BG001|Baseline|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
11001032|NCT01058096|BG002|Baseline|Total|Total of all reporting groups
11001033|NCT01058096|FG000|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
11001034|NCT01058096|FG001|Participant Flow|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
11001035|NCT01058096|OG000|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
11001036|NCT01058096|OG001|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
11001037|NCT01058096|EG000|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
11001038|NCT01058096|EG001|Reported Event|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
11001039|NCT01058239|BG000|Baseline|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
11001040|NCT01058239|FG000|Participant Flow|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
11001041|NCT01058239|OG000|Outcome|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
11001042|NCT01058239|EG000|Reported Event|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
11001043|NCT01058265|BG000|Baseline|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
11001044|NCT01058265|BG001|Baseline|Standard|Standard general medical evaluation.
11001045|NCT01058265|BG002|Baseline|Total|Total of all reporting groups
11001046|NCT01058265|FG000|Participant Flow|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
11001047|NCT01058265|FG001|Participant Flow|Standard|Standard general medical evaluation.
11001048|NCT01058265|OG000|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
11001049|NCT01058265|OG001|Outcome|Standard|Standard general medical evaluation.
11001050|NCT01058265|EG000|Reported Event|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
11001051|NCT01058265|EG001|Reported Event|Standard|Standard general medical evaluation.
11001052|NCT01058304|BG000|Baseline|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
11224015|NCT02357394|OG000|Outcome|Device: Arabin Pessary|"Participants randomized to this group will receive the pessary.~Arabin Pessary: Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team."
11224016|NCT02357394|OG001|Outcome|Standard of Care|Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.
11224017|NCT02357394|EG000|Reported Event|Device: Arabin Pessary|"Participants randomized to this group will receive the pessary.~Arabin Pessary: Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team."
11001053|NCT01058304|BG001|Baseline|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
11001054|NCT01058304|BG002|Baseline|Total|Total of all reporting groups
11001055|NCT01058304|FG000|Participant Flow|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
11001056|NCT01058304|FG001|Participant Flow|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
11001057|NCT01058304|OG000|Outcome|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
11001058|NCT01058304|OG001|Outcome|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
11001059|NCT01058304|EG000|Reported Event|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
11001060|NCT01058304|EG001|Reported Event|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
11001061|NCT01058356|BG000|Baseline|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
11001062|NCT01058356|FG000|Participant Flow|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
11001063|NCT01058356|OG000|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
11001064|NCT01058356|EG000|Reported Event|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
11001065|NCT01058395|BG000|Baseline|800 mg Loading Then 200 mg Q12|"Minocycline 800 mg. loading followed by 200 mg. Q 12 hours.~Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days."
11001066|NCT01058395|BG001|Baseline|800 mg Loading Then 400 mg Q12|"Minocycline 800 mg. loading followed by 400 mg. Q 12 hours.~Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days."
11001067|NCT01058395|BG002|Baseline|Total|Total of all reporting groups
11001068|NCT01058395|FG000|Participant Flow|800 mg Loading Then 200 mg Q12|"Minocycline 800 mg. loading followed by 200 mg. Q 12 hours.~Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days."
11001069|NCT01058395|FG001|Participant Flow|800 mg Loading Then 400 mg Q12|"Minocycline 800 mg. loading followed by 400 mg. Q 12 hours.~Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days."
11001070|NCT01058395|OG000|Outcome|800 mg Loading Then 200 mg Q12|"Minocycline 800 mg. loading followed by 200 mg. Q 12 hours.~Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days."
11001071|NCT01058395|OG001|Outcome|800 mg Loading Then 400 mg Q12|"Minocycline 800 mg. loading followed by 400 mg. Q 12 hours.~Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days."
11001072|NCT01058395|EG000|Reported Event|800 mg Loading Then 200 mg Q12|"Minocycline 800 mg. loading followed by 200 mg. Q 12 hours.~Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days."
11001073|NCT01058395|EG001|Reported Event|800 mg Loading Then 400 mg Q12|"Minocycline 800 mg. loading followed by 400 mg. Q 12 hours.~Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days."
11001074|NCT01058421|BG000|Baseline|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
11001075|NCT01058421|BG001|Baseline|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
11001076|NCT01058421|BG002|Baseline|Total|Total of all reporting groups
11001077|NCT01058421|FG000|Participant Flow|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
11001078|NCT01058421|FG001|Participant Flow|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
11001079|NCT01058421|OG000|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
11001080|NCT01058421|OG001|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
11001081|NCT01058421|EG000|Reported Event|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
11001082|NCT01058421|EG001|Reported Event|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
11001083|NCT01058655|BG000|Baseline|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001084|NCT01058655|BG001|Baseline|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001085|NCT01058655|BG002|Baseline|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001086|NCT01058655|BG003|Baseline|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001087|NCT01058655|BG004|Baseline|Total|Total of all reporting groups
11001088|NCT01058655|FG000|Participant Flow|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001089|NCT01058655|FG001|Participant Flow|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001090|NCT01058655|FG002|Participant Flow|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001091|NCT01058655|FG003|Participant Flow|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001092|NCT01058655|OG000|Outcome|Phase I: Evaluable|All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
11001093|NCT01058655|OG000|Outcome|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001094|NCT01058655|OG001|Outcome|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11224018|NCT02357394|EG001|Reported Event|Standard of Care|Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.
11001095|NCT01058655|OG002|Outcome|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001096|NCT01058655|OG000|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001097|NCT01058655|EG000|Reported Event|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001098|NCT01058655|EG001|Reported Event|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001099|NCT01058655|EG002|Reported Event|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001100|NCT01058655|EG003|Reported Event|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
11001101|NCT01058668|BG000|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
11001102|NCT01058668|BG001|Baseline|Cariprazine (3-6 mg/Day)|Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
11001103|NCT01058668|BG002|Baseline|Cariprazine (6-12 mg/Day)|Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
11001104|NCT01058668|BG003|Baseline|Total|Total of all reporting groups
11001105|NCT01058668|FG000|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
11001106|NCT01058668|FG001|Participant Flow|Cariprazine (3-6 mg/Day)|Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
11001107|NCT01058668|FG002|Participant Flow|Cariprazine (6-12 mg/Day)|Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
11001108|NCT01058668|OG000|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
11001109|NCT01058668|OG001|Outcome|Cariprazine (3-6 mg/Day)|Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
11001110|NCT01058668|OG002|Outcome|Cariprazine (6-12 mg/Day)|Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
11001111|NCT01058668|EG000|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
11001112|NCT01058668|EG001|Reported Event|Cariprazine (3-6 mg/Day)|Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
11001113|NCT01058668|EG002|Reported Event|Cariprazine (6-12 mg/Day)|Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
11001114|NCT01058707|BG000|Baseline|MLN0128 QD|MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
11001115|NCT01058707|BG001|Baseline|MLN0128 QW|MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
11001116|NCT01058707|BG002|Baseline|MLN0128 QDx3d QW|MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
11001117|NCT01058707|BG003|Baseline|MLN0128 QDx5d QW|MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
11001118|NCT01058707|BG004|Baseline|MLN0128 5 mg QD|MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
11001119|NCT01058707|BG005|Baseline|MLN0128 30 mg QW|MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
11001120|NCT01058707|BG006|Baseline|MLN0128 40 mg QW|MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
11001121|NCT01058707|BG007|Baseline|Total|Total of all reporting groups
11001122|NCT01058707|FG000|Participant Flow|MLN0128 QD|MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
11001123|NCT01058707|FG001|Participant Flow|MLN0128 QW|MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
11001124|NCT01058707|FG002|Participant Flow|MLN0128 QDx3d QW|MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
11001125|NCT01058707|FG003|Participant Flow|MLN0128 QDx5d QW|MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
11001126|NCT01058707|FG004|Participant Flow|MLN0128 5 mg QD|MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
11001127|NCT01058707|FG005|Participant Flow|MLN0128 30 mg QW|MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
11001128|NCT01058707|FG006|Participant Flow|MLN0128 40 mg QW|MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
11001129|NCT01058707|OG000|Outcome|MLN0128 QD|MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
11001130|NCT01058707|OG001|Outcome|MLN0128 QW|MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
11001131|NCT01058707|OG002|Outcome|MLN0128 QDx3d QW|MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
11001132|NCT01058707|OG003|Outcome|MLN0128 QDx5d QW|MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
11001133|NCT01058707|OG004|Outcome|MLN0128 5 mg QD|MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
11001134|NCT01058707|OG005|Outcome|MLN0128 30 mg QW|MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
11001135|NCT01058707|OG006|Outcome|MLN0128 40 mg QW|MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
11001136|NCT01058707|OG000|Outcome|MLN0128 5 mg QD|MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
11001137|NCT01058707|OG001|Outcome|MLN0128 30 mg QW|MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
11001138|NCT01058707|OG002|Outcome|MLN0128 40 mg QW|MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
11001139|NCT01058707|OG000|Outcome|MLN0128 2 mg QD|MLN0128 2 mg capsule, orally, QD in 28-day cycle (Up to 10.1 weeks).
11001140|NCT01058707|OG001|Outcome|MLN0128 4 mg QD|MLN0128 4 mg capsule, orally, QD in 28-day cycle (Up to 14.0 weeks)
11001141|NCT01058707|OG002|Outcome|MLN0128 6 mg QD|MLN0128 6 mg capsule, orally, QD in 28-day cycle (Up to 32.0 weeks).
11001142|NCT01058707|OG003|Outcome|MLN0128 7 mg QD|MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 52.1 weeks).
11001143|NCT01058707|OG004|Outcome|MLN0128 7 mg QW|MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 7.0 weeks).
11001144|NCT01058707|OG005|Outcome|MLN0128 10 mg QW|MLN0128 10 mg, capsule, orally QW in 28-day cycle (Up to 15.1 weeks).
11001145|NCT01058707|OG006|Outcome|MLN0128 15 mg QW|MLN0128 15 mg, capsule, orally QW in 28-day cycle (Up to 7.1 weeks).
11001146|NCT01058707|OG007|Outcome|MLN0128 20 mg QW|MLN0128 20 mg, capsule, orally QW in 28-day cycle (Up to 10.1 weeks).
11001147|NCT01058707|OG008|Outcome|MLN0128 30 mg QW|MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
11001148|NCT01058707|OG009|Outcome|MLN0128 40 mg QW|MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
11001149|NCT01058707|OG010|Outcome|MLN0128 6 mg QDx3dQW|MLN0128 6 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 8.4 weeks).
11001150|NCT01058707|OG011|Outcome|MLN0128 9 mg QDx3d QW|MLN0128 9 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 129.4 weeks).
11001151|NCT01058707|OG012|Outcome|MLN0128 12 mg QDx3d QW|MLN0128 12 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 11.4 weeks).
11001152|NCT01058707|OG013|Outcome|MLN0128 16 mg QDx3d QW|MLN0128 16 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 31.4 weeks).
11001153|NCT01058707|OG014|Outcome|MLN0128 20 mg QDx3dQW|MLN0128 20 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 7.4 weeks).
11001154|NCT01058707|OG015|Outcome|MLN0128 7 mg QDx5dQW|MLN0128 7 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 15.9 weeks).
11224019|NCT02357420|BG000|Baseline|Placebo|Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
11224020|NCT02357420|BG001|Baseline|Relamorelin 10 μg|Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.
11224021|NCT02357420|BG002|Baseline|Relamorelin 30 μg|Relamorelin 30 μg was administered SC by injection BID for 12 weeks.
11001155|NCT01058707|OG016|Outcome|MLN0128 10 mg QDx5dQW|MLN0128 10 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 161.9 weeks).
11001156|NCT01058707|OG017|Outcome|MLN0128 13 mg QDx5dQW|MLN0128 13 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 7.7 weeks).
11001157|NCT01058707|OG008|Outcome|MLN0128 30mg QW|MLN0128 30 mg, capsule, orally QW in 28-day cycle (Up to 139.4 weeks).
11001158|NCT01058707|EG000|Reported Event|MLN0128 QD|MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
11001159|NCT01058707|EG001|Reported Event|MLN0128 QW|MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
11001160|NCT01058707|EG002|Reported Event|MLN0128 QDx3d QW|MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
11001161|NCT01058707|EG003|Reported Event|MLN0128 QDx5d QW|MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
11001162|NCT01058707|EG004|Reported Event|MLN0128 5 mg QD|MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
11001163|NCT01058707|EG005|Reported Event|MLN0128 30 mg QW|MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
11001164|NCT01058707|EG006|Reported Event|MLN0128 40 mg QW|MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
11001165|NCT01058863|BG000|Baseline|Randomized Treated Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
11001166|NCT01058863|FG000|Participant Flow|All Randomized Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
11001167|NCT01058863|OG000|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
11001168|NCT01058863|OG001|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
11001169|NCT01058863|OG002|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
11001170|NCT01058863|OG003|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
11001171|NCT01058863|OG004|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
11001172|NCT01058863|OG000|Outcome|All Randomized Participants|Participants were randomized to one of five treatment arms, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
11001173|NCT01058863|EG000|Reported Event|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
11224022|NCT02357420|BG003|Baseline|Relamorelin 100 μg|Relamorelin 100 μg was administered SC by injection BID for 12 weeks.
11224023|NCT02357420|BG004|Baseline|Total|Total of all reporting groups
11001174|NCT01058863|EG001|Reported Event|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
11001175|NCT01058863|EG002|Reported Event|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
11001176|NCT01058863|EG003|Reported Event|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
11001177|NCT01058863|EG004|Reported Event|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
11001178|NCT01058941|BG000|Baseline|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
11001179|NCT01058941|BG001|Baseline|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
11001180|NCT01058941|BG002|Baseline|Total|Total of all reporting groups
11001181|NCT01058941|FG000|Participant Flow|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
11001182|NCT01058941|FG001|Participant Flow|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
11001183|NCT01058941|OG000|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
11001184|NCT01058941|OG001|Outcome|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
11001185|NCT01058941|EG000|Reported Event|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
11001186|NCT01058941|EG001|Reported Event|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
11001187|NCT01058993|BG000|Baseline|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
11001188|NCT01058993|FG000|Participant Flow|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
11001189|NCT01058993|OG000|Outcome|SINGLE Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
11001190|NCT01058993|EG000|Reported Event|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
11001191|NCT01059175|BG000|Baseline|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
11224024|NCT02357420|FG000|Participant Flow|Placebo|Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
11001192|NCT01059175|BG001|Baseline|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
11001193|NCT01059175|BG002|Baseline|Total|Total of all reporting groups
11001194|NCT01059175|FG000|Participant Flow|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
11001195|NCT01059175|FG001|Participant Flow|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
11001196|NCT01059175|OG000|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
11001197|NCT01059175|OG001|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
11001198|NCT01059175|EG000|Reported Event|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
11001199|NCT01059175|EG001|Reported Event|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
11001200|NCT01059305|BG000|Baseline|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
11001201|NCT01059305|FG000|Participant Flow|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
11001202|NCT01059305|OG000|Outcome|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
11001203|NCT01059305|EG000|Reported Event|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
11001204|NCT01059318|BG000|Baseline|Everolimus|"All patients received a starting dose of everolimus 2.5mg/day for 4 weeks, followed by a dose of 5 mg/day for 4 weeks and finally a dose of 10mg/day for 18 weeks.~The 26 week treatment period was followed by an optional extension period wherein patients continued therapy until the last patient had completed 26-weeks of treatment. The longest period a patient participated in the study was 62 weeks.~Everolimus : Everolimus was formulated as tablets in strengths of 2.5mg, 5mg and 10mg."
11001205|NCT01059318|FG000|Participant Flow|Everolimus|"All patients received a starting dose of everolimus 2.5mg/day for 4 weeks, followed by a dose of 5 mg/day for 4 weeks and finally a dose of 10mg/day for 18 weeks. The 26 week treatment period was followed by an optional extension period wherein patients continued therapy until the last patient had completed 26-weeks of treatment. The longest period a patient participated in the study was 62 weeks.~Everolimus : Everolimus was formulated as tablets in strengths of 2.5mg, 5mg and 10mg."
11001206|NCT01059318|OG000|Outcome|Everolimus 2.5 mg/Day|All patients received a starting dose of everolimus 2.5mg/day for first 4 weeks.
11001207|NCT01059318|OG001|Outcome|Everolimus 5 mg/Day|Patients from 2.5 mg/day up-titrated after 4 weeks and followed by a dose of 5 mg/day for another 4 weeks.
11001208|NCT01059318|OG002|Outcome|Everolimus 10 mg/Day|Patients who had received 2.5 mg/day for first 4 weeks, up titrated to 5 mg/day and continued for another 4 weeks, again up-titrated to 10 mg/day for 18 weeks.
11001209|NCT01059318|OG000|Outcome|Everolimus|"All patients received a starting dose of everolimus 2.5mg/day for 4 weeks, followed by a dose of 5 mg/day for 4 weeks and finally a dose of 10mg/day for 18 weeks.~Everolimus : Everolimus was formulated as tablets in strengths of 2.5mg, 5mg and 10mg."
11001210|NCT01059318|EG000|Reported Event|Everolimus|All patients received a starting dose of everolimus 2.5mg/day for 4 weeks, followed by a dose of 5 mg/day for 4 weeks and finally a dose of 10mg/day for 18 weeks. The 26 week treatment period was followed by an optional extension period wherein patients continued therapy until the last patient had completed 26-weeks of treatment. The longest period a patient participated in the study was 62 weeks.
11001211|NCT01059344|BG000|Baseline|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
11001212|NCT01059344|BG001|Baseline|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
11001213|NCT01059344|BG002|Baseline|Total|Total of all reporting groups
11001214|NCT01059344|FG000|Participant Flow|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
11001215|NCT01059344|FG001|Participant Flow|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
11001216|NCT01059344|OG000|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
11001217|NCT01059344|OG001|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
11001218|NCT01059344|OG000|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
11001219|NCT01059344|OG001|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
11001220|NCT01059344|EG000|Reported Event|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
11001221|NCT01059344|EG001|Reported Event|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
11001222|NCT01059357|BG000|Baseline|Transoral Robotic Surgery (TORS)|"Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System~Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System"
11001223|NCT01059357|FG000|Participant Flow|Transoral Robotic Surgery (TORS)|"Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System~Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System"
11001224|NCT01059357|OG000|Outcome|Transoral Robotic Surgery (TORS)|"Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System~Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System"
11001225|NCT01059357|EG000|Reported Event|Transoral Robotic Surgery (TORS)|"Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System~Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System"
11001226|NCT01059435|BG000|Baseline|Placebo SC|Participants received a single subcutaneous (SC) injection of matching placebo.
11001227|NCT01059435|BG001|Baseline|Romosozumab 0.1 mg/kg SC|Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
11001228|NCT01059435|BG002|Baseline|Romosozumab 0.3 mg/kg SC|Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
11001229|NCT01059435|BG003|Baseline|Romosozumab 1.0 mg/kg SC|Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
11001230|NCT01059435|BG004|Baseline|Romosozumab 3.0 mg/kg SC|Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
11001231|NCT01059435|BG005|Baseline|Romosozumab 5.0 mg/kg SC|Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
11001232|NCT01059435|BG006|Baseline|Romosozumab 10.0 mg/kg SC|Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
11001233|NCT01059435|BG007|Baseline|Placebo IV|Participants received a single intravenous (IV) injection of matching placebo.
11001234|NCT01059435|BG008|Baseline|Romosozumab 1.0 mg/kg IV|Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
11001235|NCT01059435|BG009|Baseline|Romosozumab 5.0 mg/kg IV|Participants received a single intravenous injection of 5.0 mg/kg romosozumab
11001236|NCT01059435|BG010|Baseline|Total|Total of all reporting groups
11001237|NCT01059435|FG000|Participant Flow|Placebo SC|Participants received a single subcutaneous (SC) injection of matching placebo.
11001238|NCT01059435|FG001|Participant Flow|Romosozumab 0.1 mg/kg SC|Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
11001239|NCT01059435|FG002|Participant Flow|Romosozumab 0.3 mg/kg SC|Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
11001240|NCT01059435|FG003|Participant Flow|Romosozumab 1.0 mg/kg SC|Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
11001241|NCT01059435|FG004|Participant Flow|Romosozumab 3.0 mg/kg SC|Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
11001242|NCT01059435|FG005|Participant Flow|Romosozumab 5.0 mg/kg SC|Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
11001243|NCT01059435|FG006|Participant Flow|Romosozumab 10.0 mg/kg SC|Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
11001244|NCT01059435|FG007|Participant Flow|Placebo IV|Participants received a single intravenous (IV) injection of matching placebo.
11001245|NCT01059435|FG008|Participant Flow|Romosozumab 1.0 mg/kg IV|Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
11001246|NCT01059435|FG009|Participant Flow|Romosozumab 5.0 mg/kg IV|Participants received a single intravenous injection of 5.0 mg/kg romosozumab
11001247|NCT01059435|OG000|Outcome|Placebo SC|Participants received a single subcutaneous (SC) injection of matching placebo.
11001248|NCT01059435|OG001|Outcome|Romosozumab 0.1 mg/kg SC|Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
11001249|NCT01059435|OG002|Outcome|Romosozumab 0.3 mg/kg SC|Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
11001250|NCT01059435|OG003|Outcome|Romosozumab 1.0 mg/kg SC|Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
11001251|NCT01059435|OG004|Outcome|Romosozumab 3.0 mg/kg SC|Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
11001252|NCT01059435|OG005|Outcome|Romosozumab 5.0 mg/kg SC|Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
11001253|NCT01059435|OG006|Outcome|Romosozumab 10.0 mg/kg SC|Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
11001254|NCT01059435|OG007|Outcome|Placebo IV|Participants received a single intravenous (IV) injection of matching placebo.
11001255|NCT01059435|OG008|Outcome|Romosozumab 1.0 mg/kg IV|Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
11001256|NCT01059435|OG009|Outcome|Romosozumab 5.0 mg/kg IV|Participants received a single intravenous injection of 5.0 mg/kg romosozumab
11001257|NCT01059435|OG000|Outcome|Romosozumab 0.1 mg/kg SC|Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
11001258|NCT01059435|OG001|Outcome|Romosozumab 0.3 mg/kg SC|Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
11001259|NCT01059435|OG002|Outcome|Romosozumab 1.0 mg/kg SC|Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
11001260|NCT01059435|OG003|Outcome|Romosozumab 3.0 mg/kg SC|Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
11001261|NCT01059435|OG004|Outcome|Romosozumab 5.0 mg/kg SC|Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
11001262|NCT01059435|OG005|Outcome|Romosozumab 10.0 mg/kg SC|Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
11001263|NCT01059435|OG000|Outcome|Romosozumab 1.0 mg/kg IV|Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
11001264|NCT01059435|OG001|Outcome|Romosozumab 5.0 mg/kg IV|Participants received a single intravenous injection of 5.0 mg/kg romosozumab
11001265|NCT01059435|OG006|Outcome|Romosozumab 1.0 mg/kg IV|Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
11001266|NCT01059435|OG007|Outcome|Romosozumab 5.0 mg/kg IV|Participants received a single intravenous injection of 5.0 mg/kg romosozumab
10845237|NCT00265759|EG003|Reported Event|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
11001267|NCT01059435|EG000|Reported Event|Placebo SC|Participants received a single subcutaneous (SC) injection of matching placebo.
11001268|NCT01059435|EG001|Reported Event|Placebo IV|Participants received a single intravenous (IV) injection of matching placebo.
11001269|NCT01059435|EG002|Reported Event|Romosozumab 0.1 mg/kg SC|Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
11001270|NCT01059435|EG003|Reported Event|Romosozumab 0.3 mg/kg SC|Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
11001271|NCT01059435|EG004|Reported Event|Romosozumab 1.0 mg/kg SC|Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
11224025|NCT02357420|FG001|Participant Flow|Relamorelin 10 μg|Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.
11224026|NCT02357420|FG002|Participant Flow|Relamorelin 30 μg|Relamorelin 30 μg was administered SC by injection BID for 12 weeks.
11224027|NCT02357420|FG003|Participant Flow|Relamorelin 100 μg|Relamorelin 100 μg was administered SC by injection BID for 12 weeks.
11001272|NCT01059435|EG005|Reported Event|Romosozumab 10.0 mg/kg SC|Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
11001273|NCT01059435|EG006|Reported Event|Romosozumab 3.0 mg/kg SC|Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
11001274|NCT01059435|EG007|Reported Event|Romosozumab 5.0 mg/kg SC|Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
11001275|NCT01059435|EG008|Reported Event|Romosozumab 1.0 mg/kg IV|Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
11001276|NCT01059435|EG009|Reported Event|Romosozumab 5.0 mg/kg IV|Participants received a single intravenous injection of 5.0 mg/kg romosozumab.
11001277|NCT01059526|BG000|Baseline|Patients Naive to KALBITOR|HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study ecallantide: 30 mg SC
11001278|NCT01059526|BG001|Baseline|Patients Non- Naive to KALBITOR|HAE patients that have been treated with KALBITOR prior to enrollment in the study ecallantide: 30 mg SC
11001279|NCT01059526|BG002|Baseline|Total|Total of all reporting groups
11001280|NCT01059526|FG000|Participant Flow|Patients Naive to KALBITOR|HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study ecallantide: 30 mg SC
11001281|NCT01059526|FG001|Participant Flow|Patients Non- Naive to KALBITOR|HAE patients that have been treated with KALBITOR prior to enrollment in the study ecallantide: 30 mg SC
11001282|NCT01059526|OG000|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
11001283|NCT01059526|OG000|Outcome|Patients Naive to KALBITOR|HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study ecallantide: 30 mg SC
11001284|NCT01059526|OG001|Outcome|Patients Non- Naive to KALBITOR|HAE patients that have been treated with KALBITOR prior to enrollment in the study ecallantide: 30 mg SC
11001285|NCT01059526|EG000|Reported Event|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
11001286|NCT01059539|BG000|Baseline|Cariprazine 3-12 mg/Day for 16 Weeks|Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
11001287|NCT01059539|FG000|Participant Flow|Cariprazine 3-12 mg/Day for 16 Weeks|Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
11001288|NCT01059539|OG000|Outcome|Cariprazine 3-12 mg/Day for 16 Weeks|Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
11001289|NCT01059539|EG000|Reported Event|Cariprazine 3-12 mg/Day for 16 Weeks|Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
11001290|NCT01059565|BG000|Baseline|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
11001291|NCT01059565|BG001|Baseline|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
11001292|NCT01059565|BG002|Baseline|Total|Total of all reporting groups
11224028|NCT02357420|OG000|Outcome|Placebo|Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
11001293|NCT01059565|FG000|Participant Flow|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants continued to receive AZLI during the open-label phase.
11001294|NCT01059565|FG001|Participant Flow|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants switched to AZLI during the open-label phase.
11001295|NCT01059565|OG000|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
11001296|NCT01059565|OG001|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
11001297|NCT01059565|EG000|Reported Event|AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline, and were analyzed from Baseline to Week 24.
11001298|NCT01059565|EG001|Reported Event|Placebo|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline, and were analyzed from Baseline to Week 24.
11001299|NCT01059565|EG002|Reported Event|AZLI/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline and continued to receive an up to an additional 24 weeks of AZLI treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
11001300|NCT01059565|EG003|Reported Event|Placebo/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline and switched AZLI for up to 24 weeks of treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
11001301|NCT01059617|BG000|Baseline|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001302|NCT01059617|BG001|Baseline|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001303|NCT01059617|BG002|Baseline|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001304|NCT01059617|BG003|Baseline|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001305|NCT01059617|BG004|Baseline|Total|Total of all reporting groups
11001306|NCT01059617|FG000|Participant Flow|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001307|NCT01059617|FG001|Participant Flow|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001308|NCT01059617|FG002|Participant Flow|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001309|NCT01059617|FG003|Participant Flow|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11224029|NCT02357420|OG001|Outcome|Relamorelin 10 μg|Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.
11001310|NCT01059617|OG000|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001311|NCT01059617|OG001|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001312|NCT01059617|OG002|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001313|NCT01059617|OG003|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001314|NCT01059617|OG000|Outcome|Flulaval Group|Subjects received Flulaval vaccine on Day 0 and either adjuvanted or unadjuvanted formulation of Arepanrix on Days 122 and 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001315|NCT01059617|OG001|Outcome|Placebo Group|Subjects received a saline placebo on Day 0 and either adjuvanted or unadjuvanted formulation of Arepanrix on Days 122 and 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001316|NCT01059617|OG000|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm a t Days 0 and 122 and of the dominant arm at Day143.
11224030|NCT02357420|OG002|Outcome|Relamorelin 30 μg|Relamorelin 30 μg was administered SC by injection BID for 12 weeks.
11224031|NCT02357420|OG003|Outcome|Relamorelin 100 μg|Relamorelin 100 μg was administered SC by injection BID for 12 weeks.
11001317|NCT01059617|OG002|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day143.
11001318|NCT01059617|OG000|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
11001319|NCT01059617|OG001|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
11001320|NCT01059617|EG000|Reported Event|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001321|NCT01059617|EG001|Reported Event|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001322|NCT01059617|EG002|Reported Event|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001323|NCT01059617|EG003|Reported Event|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
11001324|NCT01059617|EG004|Reported Event|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
11001325|NCT01059617|EG005|Reported Event|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
11001326|NCT01059630|BG000|Baseline|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
11001327|NCT01059630|BG001|Baseline|Obinutuzumab + Bendamustine|Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
11001328|NCT01059630|BG002|Baseline|Total|Total of all reporting groups
11001329|NCT01059630|FG000|Participant Flow|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
11001330|NCT01059630|FG001|Participant Flow|Obinutuzumab + Bendamustine|Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
11001331|NCT01059630|OG000|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
11001332|NCT01059630|OG001|Outcome|Obinutuzumab + Bendamustine|Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
11001333|NCT01059630|EG000|Reported Event|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
11001334|NCT01059630|EG001|Reported Event|Obinutuzumab + Bendamustine|Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
11001335|NCT01059643|BG000|Baseline|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
11001336|NCT01059643|FG000|Participant Flow|LY2523355|"LY2523355: Dose determined by participant's body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21-day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
11224032|NCT02357420|EG000|Reported Event|Placebo|Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
11224033|NCT02357420|EG001|Reported Event|Relamorelin 10 μg|Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.
11224034|NCT02357420|EG002|Reported Event|Relamorelin 30 μg|Relamorelin 30 μg was administered SC by injection BID for 12 weeks.
11001337|NCT01059643|OG000|Outcome|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
11001338|NCT01059643|OG000|Outcome|5 mg/m² LY2523355|LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
11001339|NCT01059643|OG001|Outcome|6 mg/m² LY253355|LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
11001340|NCT01059643|OG000|Outcome|5 mg/m²LY2523355|LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
11001341|NCT01059643|EG000|Reported Event|LY2523355|"LY2523355: Dose determined by participant's body surface area: 5 milligrams/meter squared (mg/m²) or 6 mg/m², administered intravenously on days 1, 2, 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously 24 hours after third dose of LY2523355 on day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
11001342|NCT01059682|BG000|Baseline|Dalcetrapib|Dalcetrapib: Dalcetrapib 600 mg orally once daily
11001343|NCT01059682|BG001|Baseline|Placebo|Placebo: Placebo orally once daily
11001344|NCT01059682|BG002|Baseline|Total|Total of all reporting groups
11001345|NCT01059682|FG000|Participant Flow|Dalcetrapib|Dalcetrapib: Dalcetrapib 600 mg orally once daily
11001346|NCT01059682|FG001|Participant Flow|Placebo|Placebo: Placebo orally once daily
11001347|NCT01059682|OG000|Outcome|Dalcetrapib|Dalcetrapib: Dalcetrapib 600 mg orally once daily
11001348|NCT01059682|OG001|Outcome|Placebo|Placebo: Placebo orally once daily
11001349|NCT01059682|EG000|Reported Event|Dalcetrapib|Dalcetrapib: Dalcetrapib 600 mg orally once daily
11001350|NCT01059682|EG001|Reported Event|Placebo|Placebo: Placebo orally once daily
11001351|NCT01059760|BG000|Baseline|Fasting Day First|28±4 hours of water-only fasting followed by 28±4 hours fed
11001352|NCT01059760|BG001|Baseline|Fed Day First|28± 4 hours fed followed by 28± 4 hours of fasting
11001353|NCT01059760|BG002|Baseline|Total|Total of all reporting groups
11001354|NCT01059760|FG000|Participant Flow|Fasting Day First|28±4 hours of water-only fasting followed by 28±4 hours fed
11001355|NCT01059760|FG001|Participant Flow|Fed Day First|28± 4 hours fed followed by 28± 4 hours of fasting
11001356|NCT01059760|OG000|Outcome|Baseline Value|
11001357|NCT01059760|OG001|Outcome|Change While Fasting|
11001358|NCT01059760|OG002|Outcome|Change When Fed|
11001359|NCT01059760|EG000|Reported Event|Fasting Day First|Includes those who fasted on the 1st day.
11001360|NCT01059760|EG001|Reported Event|Fed Day First|Includes those who fasted on the 2nd day.
11001361|NCT01059773|BG000|Baseline|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
11001362|NCT01059773|BG001|Baseline|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
11001363|NCT01059773|BG002|Baseline|Total|Total of all reporting groups
11001364|NCT01059773|FG000|Participant Flow|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
11001365|NCT01059773|FG001|Participant Flow|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
11001366|NCT01059773|OG000|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
11001367|NCT01059773|OG001|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
11001368|NCT01059773|OG002|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
11001369|NCT01059773|OG003|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
11001370|NCT01059773|OG000|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
11001371|NCT01059773|OG001|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
11001372|NCT01059773|OG001|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
11224035|NCT02357420|EG003|Reported Event|Relamorelin 100 μg|Relamorelin 100 μg was administered SC by injection BID for 12 weeks.
11001373|NCT01059773|EG000|Reported Event|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
11001374|NCT01059773|EG001|Reported Event|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
11001375|NCT01059799|BG000|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
11001376|NCT01059799|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
11001377|NCT01059799|BG002|Baseline|Total|Total of all reporting groups
11001378|NCT01059799|FG000|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
11001379|NCT01059799|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
11001380|NCT01059799|OG000|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
11001381|NCT01059799|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
11001382|NCT01059799|EG000|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
11001383|NCT01059799|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
11001384|NCT01059812|BG000|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
11001385|NCT01059812|BG001|Baseline|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
11001386|NCT01059812|BG002|Baseline|Total|Total of all reporting groups
11001387|NCT01059812|FG000|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
11001388|NCT01059812|FG001|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
11001389|NCT01059812|OG000|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
11001390|NCT01059812|OG001|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
11001391|NCT01059812|EG000|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
11001392|NCT01059812|EG001|Reported Event|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
11001393|NCT01059825|BG000|Baseline|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
11001394|NCT01059825|BG001|Baseline|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001395|NCT01059825|BG002|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11224036|NCT02357459|BG000|Baseline|FX006 32mg|FX006: Single 5 mL IA injection
11001396|NCT01059825|BG003|Baseline|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001397|NCT01059825|BG004|Baseline|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001398|NCT01059825|BG005|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
11001399|NCT01059825|BG006|Baseline|Total|Total of all reporting groups
11001400|NCT01059825|FG000|Participant Flow|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
11001401|NCT01059825|FG001|Participant Flow|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001402|NCT01059825|FG002|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001403|NCT01059825|FG003|Participant Flow|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001404|NCT01059825|FG004|Participant Flow|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001405|NCT01059825|FG005|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
11001406|NCT01059825|FG006|Participant Flow|Metformin Run-in|Participants received open-label metformin during the run-in period.
11224037|NCT02357459|BG001|Baseline|Placebo|Normal Saline: Single 5 mL IA injection
11224038|NCT02357459|BG002|Baseline|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11001407|NCT01059825|OG000|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
11001408|NCT01059825|OG001|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001409|NCT01059825|OG002|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001410|NCT01059825|OG003|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001411|NCT01059825|OG004|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001412|NCT01059825|OG005|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
11001413|NCT01059825|OG006|Outcome|Metformin Run-in|Participants received open-label metformin during the run-in period.
11001414|NCT01059825|EG000|Reported Event|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
11001415|NCT01059825|EG001|Reported Event|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001416|NCT01059825|EG002|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001417|NCT01059825|EG003|Reported Event|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001418|NCT01059825|EG004|Reported Event|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
11001419|NCT01059825|EG005|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
11001420|NCT01059825|EG006|Reported Event|Metformin Run-in|Participants received open-label metformin during the run-in period.
11001421|NCT01059851|BG000|Baseline|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
11001422|NCT01059851|BG001|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
11001423|NCT01059851|BG002|Baseline|Total|Total of all reporting groups
11001424|NCT01059851|FG000|Participant Flow|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
11001425|NCT01059851|FG001|Participant Flow|Healthy Participants (Severe Impairment Controls) (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
11001426|NCT01059851|FG002|Participant Flow|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
11001427|NCT01059851|FG003|Participant Flow|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
11001428|NCT01059851|FG004|Participant Flow|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
11001429|NCT01059851|FG005|Participant Flow|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
11001430|NCT01059851|OG000|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
11001431|NCT01059851|OG001|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
11001432|NCT01059851|OG000|Outcome|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
11001433|NCT01059851|OG001|Outcome|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
11001434|NCT01059851|OG002|Outcome|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
11001435|NCT01059851|OG003|Outcome|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
11001436|NCT01059851|EG000|Reported Event|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
11224039|NCT02357459|BG003|Baseline|Total|Total of all reporting groups
11001437|NCT01059851|EG001|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
11001438|NCT01059864|BG000|Baseline|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
11224040|NCT02357459|FG000|Participant Flow|FX006 32mg|161 subjects received FX006 32 mg as a single 5 mL IA injection
11224041|NCT02357459|FG001|Participant Flow|Placebo|162 subjects received normal saline as a single 5 mL IA injection.
11224042|NCT02357459|FG002|Participant Flow|TCA IR 40 mg|161 subjects received TCA IR 40 mg as a single 1 mL IA injection
11224043|NCT02357459|OG000|Outcome|FX006 32mg|FX006: Single 5 mL IA injection
11001439|NCT01059864|FG000|Participant Flow|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
11001440|NCT01059864|FG001|Participant Flow|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
11001441|NCT01059864|FG002|Participant Flow|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
11001442|NCT01059864|OG000|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
11001443|NCT01059864|OG001|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
11001444|NCT01059864|EG000|Reported Event|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
11001445|NCT01059864|EG001|Reported Event|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
11001446|NCT01059864|EG002|Reported Event|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
11001447|NCT01059877|BG000|Baseline|Treatment Group|received actual tx
11001448|NCT01059877|BG001|Baseline|Placebo Group|received placebo tx
11224044|NCT02357459|OG001|Outcome|Placebo|Normal Saline: Single 5 mL IA injection.
11001449|NCT01059877|BG002|Baseline|Total|Total of all reporting groups
11001450|NCT01059877|FG000|Participant Flow|Treatment Group|received actual tx
11001451|NCT01059877|FG001|Participant Flow|Placebo Group|received placebo tx
11001452|NCT01059877|OG000|Outcome|Treatment Group|received actual tx
11001453|NCT01059877|OG001|Outcome|Placebo Group|received placebo tx
11001454|NCT01059877|EG000|Reported Event|Treatment Group|received actual tx
11001455|NCT01059877|EG001|Reported Event|Placebo Group|received placebo tx
11001456|NCT01059903|BG000|Baseline|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
11001457|NCT01059903|BG001|Baseline|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
11001458|NCT01059903|BG002|Baseline|Total|Total of all reporting groups
11001459|NCT01059903|FG000|Participant Flow|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
11001460|NCT01059903|FG001|Participant Flow|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
11001461|NCT01059903|OG000|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
11001462|NCT01059903|OG001|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
11001463|NCT01059903|EG000|Reported Event|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
11001464|NCT01059903|EG001|Reported Event|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
11001465|NCT01059929|BG000|Baseline|Dexmedetomidine|"Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.~Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS~Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale~Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)~Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility"
11001466|NCT01059929|BG001|Baseline|Propofol|"Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.~Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS~Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale~Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)~Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility"
11001467|NCT01059929|BG002|Baseline|Total|Total of all reporting groups
11224045|NCT02357459|OG000|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
11224046|NCT02357459|OG001|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11224047|NCT02357459|OG001|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
11224048|NCT02357459|OG002|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11224049|NCT02357459|EG000|Reported Event|FX006 32mg|FX006: Single 5 mL IA injection
11224050|NCT02357459|EG001|Reported Event|Placebo|Normal Saline: Single 5 mL IA injection
11224051|NCT02357459|EG002|Reported Event|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11001468|NCT01059929|FG000|Participant Flow|Dexmedetomidine|"Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.~Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS~Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale~Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)~Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility"
11001469|NCT01059929|FG001|Participant Flow|Propofol|"Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.~Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS~Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale~Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)~Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility"
11001470|NCT01059929|OG000|Outcome|Dexmedetomidine|"Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.~Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS~Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale~Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)~Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility"
11001471|NCT01059929|OG001|Outcome|Propofol|"Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.~Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS~Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale~Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)~Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility"
11001472|NCT01059929|EG000|Reported Event|Dexmedetomidine|"Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.~Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS~Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale~Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)~Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility"
11001473|NCT01059929|EG001|Reported Event|Propofol|"Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.~Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS~Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale~Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)~Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility"
11001474|NCT01059994|BG000|Baseline|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
11001475|NCT01059994|BG001|Baseline|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
11001476|NCT01059994|BG002|Baseline|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
11001477|NCT01059994|BG003|Baseline|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
11001478|NCT01059994|BG004|Baseline|Total|Total of all reporting groups
11001479|NCT01059994|FG000|Participant Flow|Sildenafil Placebo Young|Sildenafil placebo: Oral, daily, 1 week.
11001480|NCT01059994|FG001|Participant Flow|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
11224052|NCT02357485|BG000|Baseline|Treatment Arm|Single injection of ADSC
11224053|NCT02357485|FG000|Participant Flow|Treatment Arm|Single injection of Adipose-derived Stromal Cells (ADSC) into intra-articular space of the knee
11001481|NCT01059994|FG002|Participant Flow|Sildenafil Placebo Older|Sildenafil placebo: Oral, daily, 1 week.
11001482|NCT01059994|FG003|Participant Flow|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
11001483|NCT01059994|OG000|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
11001484|NCT01059994|OG001|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
11001485|NCT01059994|OG002|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
11001486|NCT01059994|OG003|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
11001487|NCT01059994|EG000|Reported Event|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
11001488|NCT01059994|EG001|Reported Event|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
11001489|NCT01059994|EG002|Reported Event|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
11001490|NCT01059994|EG003|Reported Event|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
11001491|NCT01060007|BG000|Baseline|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
11001492|NCT01060007|FG000|Participant Flow|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
11224054|NCT02357485|OG000|Outcome|Treatment Arm|Single injection of ADSC
11224055|NCT02357485|OG000|Outcome|Treatment Arm|"Single injection of ADSC~ADSC: Single injection of ADSC"
11001493|NCT01060007|OG000|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
11001494|NCT01060007|OG000|Outcome|Pre-treatment|
11001495|NCT01060007|OG001|Outcome|Pre-surgery|
11001496|NCT01060007|OG002|Outcome|1 Year Post-treatment|
11001497|NCT01060007|EG000|Reported Event|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
11001498|NCT01060020|BG000|Baseline|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
11001499|NCT01060020|FG000|Participant Flow|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
11001500|NCT01060020|OG000|Outcome|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
11001501|NCT01060020|OG000|Outcome|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
11001502|NCT01060020|EG000|Reported Event|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
11001503|NCT01060059|BG000|Baseline|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
11001504|NCT01060059|BG001|Baseline|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
11001505|NCT01060059|BG002|Baseline|Total|Total of all reporting groups
11001506|NCT01060059|FG000|Participant Flow|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
11001507|NCT01060059|FG001|Participant Flow|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
11001508|NCT01060059|OG000|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
11001509|NCT01060059|OG001|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
11001510|NCT01060059|OG000|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
11001511|NCT01060059|OG001|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
11001512|NCT01060059|EG000|Reported Event|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
11001513|NCT01060059|EG001|Reported Event|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
11001514|NCT01060072|BG000|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
11001515|NCT01060072|BG001|Baseline|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
11001516|NCT01060072|BG002|Baseline|Total|Total of all reporting groups
11001517|NCT01060072|FG000|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
11224056|NCT02357485|EG000|Reported Event|Treatment Arm|Single injection of ADSC
11224057|NCT02357576|BG000|Baseline|Reduced Lipid|"Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition.~Intralipid 20% I.V. Fat Emulsion"
11001518|NCT01060072|FG001|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
11001519|NCT01060072|OG000|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
11001520|NCT01060072|OG001|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
11001521|NCT01060072|EG000|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
11001522|NCT01060072|EG001|Reported Event|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
11001523|NCT01060098|BG000|Baseline|Rheumatoid Arthritis|Participants with Rheumatoid arthritis
11001524|NCT01060098|BG001|Baseline|Ankylosing Spondylitis|Participants with Ankylosing spondylitis
11001525|NCT01060098|BG002|Baseline|Psoriatic Arthritis|Participants with psoriatic arthritis
11001526|NCT01060098|BG003|Baseline|Total|Total of all reporting groups
11001527|NCT01060098|FG000|Participant Flow|Rheumatoid Arthritis|Participants with Rheumatoid arthritis anti-TNF therapy (etanercept or adalimumab): Biological DMARD
11001528|NCT01060098|FG001|Participant Flow|Ankylosing Spondylitis|Participants with Ankylosing spondylitis
11001529|NCT01060098|FG002|Participant Flow|Psoriatic Arthritis|Participants with Psoriatic arthritis
11001530|NCT01060098|OG000|Outcome|Rheumatoid Arthritis|Participants with Rheumatoid arthritis
11001531|NCT01060098|OG001|Outcome|Ankylosing Spondylitis|Participants with Ankylosing spondylitis
11001532|NCT01060098|OG002|Outcome|Psoriatic Arthritis|Participants with Psoriatic arthritis
11001533|NCT01060098|EG000|Reported Event|Rheumatoid Arthritis|Participants with Rheumatoid arthritis
11001534|NCT01060098|EG001|Reported Event|Ankylosing Spondylitis|Participants with Ankylosing spondylitis
11001535|NCT01060098|EG002|Reported Event|Psoriatic Arthritis|Participants with Psoriatic arthritis
11001536|NCT01060111|BG000|Baseline|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
11001537|NCT01060111|BG001|Baseline|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
11001538|NCT01060111|BG002|Baseline|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
11001539|NCT01060111|BG003|Baseline|Total|Total of all reporting groups
11001540|NCT01060111|FG000|Participant Flow|Topiramate Standard|Topiramate 25 milligram (mg) was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
11099073|NCT01579565|FG000|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11001541|NCT01060111|FG001|Participant Flow|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
11001542|NCT01060111|FG002|Participant Flow|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
11001543|NCT01060111|OG000|Outcome|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
11001544|NCT01060111|OG001|Outcome|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
11001545|NCT01060111|OG002|Outcome|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
11001546|NCT01060111|OG000|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
11001547|NCT01060111|OG001|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
11001548|NCT01060111|OG002|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
11001549|NCT01060111|EG000|Reported Event|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
11001550|NCT01060111|EG001|Reported Event|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
11001551|NCT01060111|EG002|Reported Event|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
11001552|NCT01060124|BG000|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
11001553|NCT01060124|FG000|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
11001554|NCT01060124|OG000|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
11001555|NCT01060124|EG000|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
11001556|NCT01060150|BG000|Baseline|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
11001557|NCT01060150|FG000|Participant Flow|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
11001558|NCT01060150|OG000|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
11001559|NCT01060150|EG000|Reported Event|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
11001560|NCT01060345|BG000|Baseline|Women With Ductal Carcinoma in Situ|"Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E~Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery"
11001561|NCT01060345|FG000|Participant Flow|Women With Ductal Carcinoma in Situ|"Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E~Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery"
11001562|NCT01060345|OG000|Outcome|Women With Ductal Carcinoma in Situ|"Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E~Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery"
11001563|NCT01060345|EG000|Reported Event|Women With Ductal Carcinoma in Situ|"Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E~Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery"
11001564|NCT01060384|BG000|Baseline|Phase 1/Phase II|"There will be three planned dose cohorts for the Lenalidomide in the Phase 1 portion of this trial. Three evaluable patients will be enrolled in to each of the dose cohorts with an additional 3 patients to be enrolled in the maximum tolerated dose (MTD). Patients will be enrolled in to Phase II using the MTD for Lenalidomide that was determined in Phase 1.~Dose Cohort -1: 10 mg per day. This cohort will be used only if needed due to dose reduction in Dose cohort +1.~Dose Cohort +1: 15 mg per day. Dose Cohort +2: 20 mg per day. Dose Cohort +3: 25 mg per day.~Phase II: An additional 29 response-evaluable patients will be enrolled into Phase II using the MTD for Lenalidomide that was determined in Phase 1.~All subjects will receive the same dosing schedule for Ofatumumab regardless of which Phase of the trial they are enrolled."
11001565|NCT01060384|FG000|Participant Flow|Phase 1: Cohort -1|Cohort -1 received 10 mg Lenalidomide per day on days 1-21 every 28 days.
11001566|NCT01060384|FG001|Participant Flow|Phase 1: Cohort #1|Cohort 1 received 15 mg Lenalidomide per day on days 1-21 every 28 days.
11001567|NCT01060384|FG002|Participant Flow|Phase 1: Cohort #2|Cohort 2 received 20 mg Lenalidomide on days 1-21 every 28 days.
11001568|NCT01060384|FG003|Participant Flow|Phase 1: Cohort #3|Cohort 3 received 25 mg Lenalidomide per day on days 1-21 every 28 days.
11001569|NCT01060384|FG004|Participant Flow|Phase II: Event Free Survival and Overall Survival|Event free and overall survival probabilities will be computed on all patients receiving the MTD dose, including those patients in the phase I portion of the study.
11001570|NCT01060384|OG000|Outcome|Phase 1|Maximum Tolerated Dose (MTD) of Lenalidomide
11001571|NCT01060384|OG000|Outcome|Phase II: Lemalidomide at MTD and Ofatumumab|Event free and overall survival probabilities will be computed on all patients receiving the MTD dose, including those patients in the phase I portion of the study.
11001572|NCT01060384|EG000|Reported Event|Phase I: Cohort -1|Lenalidomide: 10 mg per day.
11001573|NCT01060384|EG001|Reported Event|Phase 1: Cohort #1|Lenalidomide: 15mg per day.
11001574|NCT01060384|EG002|Reported Event|Phase 1: Cohort #2|Lenalidomide: 20mg per day.
11001575|NCT01060384|EG003|Reported Event|Phase 1: Cohort #3|Lenalidomide: 25 mg per day.
11001576|NCT01060384|EG004|Reported Event|Phase 1 and Phase II: Event Free Survival and Overall Survival|Lenalidomide at maximum tolerated dose (MTD).
11001577|NCT01060540|BG000|Baseline|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
11001578|NCT01060540|BG001|Baseline|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
11001579|NCT01060540|BG002|Baseline|Total|Total of all reporting groups
11001580|NCT01060540|FG000|Participant Flow|CR+G|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)~results of genetic testing for type 2 diabetes based on the genes TCF7L2, PPARG, or KCNJ11"
11001581|NCT01060540|FG001|Participant Flow|CR+EYE|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)~eye disease counseling"
11001582|NCT01060540|OG000|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
11001583|NCT01060540|OG001|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
11001584|NCT01060540|OG000|Outcome|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
11001585|NCT01060540|OG001|Outcome|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
11001586|NCT01060540|EG000|Reported Event|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
11001587|NCT01060540|EG001|Reported Event|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
11001588|NCT01060553|BG000|Baseline|Arm 1|24 semi-individualized acupuncture treatments over 12 weeks. The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
11001589|NCT01060553|FG000|Participant Flow|Active Treatment|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
11001590|NCT01060553|FG001|Participant Flow|Wait List Control|this group was originall randomly assigned to a wait list control. due to severe recruitment and retention problems, data was collected in those willing to be treated after the wait list. this treatment data is combined with the original treatment group. this group received the same treatment, namely The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
11001591|NCT01060553|OG000|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment"
11001592|NCT01060553|OG000|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
11224058|NCT02357576|BG001|Baseline|Standard Lipid|"Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition.~Intralipid 20% I.V. Fat Emulsion"
11224059|NCT02357576|BG002|Baseline|Total|Total of all reporting groups
11001593|NCT01060553|EG000|Reported Event|Arm 1|The treatment program will consist of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
11001594|NCT01060592|BG000|Baseline|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
11001595|NCT01060592|BG001|Baseline|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
11001596|NCT01060592|BG002|Baseline|Total|Total of all reporting groups
11001597|NCT01060592|FG000|Participant Flow|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
11001598|NCT01060592|FG001|Participant Flow|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
11001599|NCT01060592|OG000|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
11001600|NCT01060592|OG001|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
11001601|NCT01060592|EG000|Reported Event|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
11001602|NCT01060592|EG001|Reported Event|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
11001603|NCT01060670|BG000|Baseline|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing and a gauze wrap and, an offloading/protective device were to be used in conjunction with the IDRT.
11001604|NCT01060670|BG001|Baseline|Control Treatment|Control Treatment consisted of moist wound therapy and was comprised of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing and a gauze wrap and, an offloading/protective device
11001605|NCT01060670|BG002|Baseline|Total|Total of all reporting groups
11001606|NCT01060670|FG000|Participant Flow|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
11001607|NCT01060670|FG001|Participant Flow|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
11001608|NCT01060670|OG000|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
11001609|NCT01060670|OG001|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
11001610|NCT01060670|OG000|Outcome|Dermal Replacement Device|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
11001611|NCT01060670|OG001|Outcome|Moist Wound Therapy|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
11001612|NCT01060670|EG000|Reported Event|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
11001613|NCT01060670|EG001|Reported Event|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
11001614|NCT01061008|BG000|Baseline|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
11001615|NCT01061008|BG001|Baseline|Treatment as Usual|
11001616|NCT01061008|BG002|Baseline|Total|Total of all reporting groups
11001617|NCT01061008|FG000|Participant Flow|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
11001618|NCT01061008|FG001|Participant Flow|Treatment as Usual|
11001619|NCT01061008|OG000|Outcome|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
11001620|NCT01061008|OG001|Outcome|Treatment as Usual|
11001621|NCT01061008|EG000|Reported Event|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
11001622|NCT01061008|EG001|Reported Event|Treatment as Usual|
11001623|NCT01061034|BG000|Baseline|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
11001624|NCT01061034|FG000|Participant Flow|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
11001625|NCT01061034|OG000|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
11001626|NCT01061034|EG000|Reported Event|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
11001627|NCT01061177|BG000|Baseline|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
11001628|NCT01061177|FG000|Participant Flow|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
11001629|NCT01061177|OG000|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
11001630|NCT01061177|EG000|Reported Event|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
11001631|NCT01061333|BG000|Baseline|All Participants|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, nedocromil or montelukast, nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
11001632|NCT01061333|FG000|Participant Flow|Placebo-Montelukast-Nedocromil-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
11001633|NCT01061333|FG001|Participant Flow|Placebo-Nedocromil-Montelukast-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
11001634|NCT01061333|OG000|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
11001635|NCT01061333|OG001|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
11001636|NCT01061333|OG002|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
11001637|NCT01061333|OG003|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
11001638|NCT01061333|OG000|Outcome|Placebo|Nedocromil placebo metered dose inhaler, Montelukast placebo tablet, Mometasone placebo twisthaler
11001639|NCT01061333|EG000|Reported Event|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
11001640|NCT01061333|EG001|Reported Event|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
11001641|NCT01061333|EG002|Reported Event|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
11001642|NCT01061333|EG003|Reported Event|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
11001643|NCT01061359|BG000|Baseline|Entire Study Population|Includes all groups enrolled in the study
11224060|NCT02357576|FG000|Participant Flow|Reduced Lipid|"Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition.~Intralipid 20% I.V. Fat Emulsion"
11001644|NCT01061359|FG000|Participant Flow|Entire Study Population|Includes all groups enrolled in the study
11001645|NCT01061359|OG000|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
11001646|NCT01061359|EG000|Reported Event|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
11001647|NCT01061385|BG000|Baseline|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
11001648|NCT01061385|BG001|Baseline|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
11001649|NCT01061385|BG002|Baseline|Total|Total of all reporting groups
11001650|NCT01061385|FG000|Participant Flow|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
11001651|NCT01061385|FG001|Participant Flow|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
11001652|NCT01061385|OG000|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
11001653|NCT01061385|OG001|Outcome|Control|Control subjects receiving diet and exercise counseling only
11001654|NCT01061385|OG001|Outcome|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
11001655|NCT01061385|EG000|Reported Event|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
11001656|NCT01061385|EG001|Reported Event|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
11001657|NCT01061476|BG000|Baseline|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
11001658|NCT01061476|FG000|Participant Flow|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
11224061|NCT02357576|FG001|Participant Flow|Standard Lipid|"Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition.~Intralipid 20% I.V. Fat Emulsion"
11224062|NCT02357576|OG000|Outcome|Reduced Lipid|"Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition.~Intralipid 20% I.V. Fat Emulsion"
11001659|NCT01061476|OG000|Outcome|Single Arm - Sleep Apnea|"Each participant had 3 sleep studies. Sleep Study #1 - the patient did not have the Provent™ device on to assess baseline sleep apnea severity. On sleep study #2 - the patient used the Provent™ device to re-assess changes in sleep apnea severity. On sleep study #3, the patient used Provent™ for assessment of the physiological effects of the device on breathing during sleep.~Participants did not use Provent™ outside of the sleep laboratory.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
11001660|NCT01061476|EG000|Reported Event|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
11001661|NCT01061528|BG000|Baseline|New Smoking Cessation Counseling|"One 60-minute individual session~Seven 2-hour group sessions~Two individual brief telephone contacts over an eight-week period.~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11001662|NCT01061528|BG001|Baseline|Standard Smoking Cessation Counseling|"One 60-minute individual session~Seven 2-hour group sessions~Two individual brief telephone contacts over an eight-week period.~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11001663|NCT01061528|BG002|Baseline|Total|Total of all reporting groups
11001664|NCT01061528|FG000|Participant Flow|Distress Tolerance Cessation Counseling|"One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11001665|NCT01061528|FG001|Participant Flow|Standard Smoking Cessation Counseling|"One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11001666|NCT01061528|OG000|Outcome|Distress Tolerance Cessation Counseling|"One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11001667|NCT01061528|OG001|Outcome|Standard Smoking Cessation Counseling|"One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11001668|NCT01061528|EG000|Reported Event|Distress Tolerance Cessation Counseling|"One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11001669|NCT01061528|EG001|Reported Event|Standard Smoking Cessation Counseling|"One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11001670|NCT01061567|BG000|Baseline|All Patients|Patients with Parkinson's disease in routine clinical practice.
11001671|NCT01061567|FG000|Participant Flow|All Patients|Patients with Parkinson's disease in routine clinical practice.
11001672|NCT01061567|OG000|Outcome|All Patients|Patients with Parkinson's disease in routine clinical practice.
11001673|NCT01061567|EG000|Reported Event|All Patients|Patients with Parkinson's disease in routine clinical practice.
11001674|NCT01061606|BG000|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
11001675|NCT01061606|FG000|Participant Flow|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
11001676|NCT01061606|OG000|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
11224063|NCT02357576|OG001|Outcome|Standard Lipid|"Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition.~Intralipid 20% I.V. Fat Emulsion"
11001677|NCT01061606|EG000|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
11001678|NCT01061671|BG000|Baseline|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
11001679|NCT01061671|BG001|Baseline|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
11001680|NCT01061671|BG002|Baseline|Total|Total of all reporting groups
11001681|NCT01061671|FG000|Participant Flow|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
11001682|NCT01061671|FG001|Participant Flow|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
11001683|NCT01061671|OG000|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
11001684|NCT01061671|OG001|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
11001685|NCT01061671|EG000|Reported Event|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
11001686|NCT01061671|EG001|Reported Event|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
11001687|NCT01061710|BG000|Baseline|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
11001688|NCT01061710|FG000|Participant Flow|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
11001689|NCT01061710|OG000|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
11001690|NCT01061710|EG000|Reported Event|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
11001691|NCT01061723|BG000|Baseline|Placebo|Placebo (for sarilumab) qw for 12 weeks.
11001692|NCT01061723|BG001|Baseline|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
11001693|NCT01061723|BG002|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
11001694|NCT01061723|BG003|Baseline|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
11001695|NCT01061723|BG004|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
11001696|NCT01061723|BG005|Baseline|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
11001697|NCT01061723|BG006|Baseline|Total|Total of all reporting groups
11001698|NCT01061723|FG000|Participant Flow|Placebo|Placebo (for sarilumab) qw for 12 weeks.
11001699|NCT01061723|FG001|Participant Flow|Sarilumab 100 mg q2w|Sarilumab 100 mg subcutaneous (SC) injection alternating with placebo q2w for 12 weeks.
11001700|NCT01061723|FG002|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
11001701|NCT01061723|FG003|Participant Flow|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
11001702|NCT01061723|FG004|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
11001703|NCT01061723|FG005|Participant Flow|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
11001704|NCT01061723|OG000|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
11001705|NCT01061723|OG001|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
11001706|NCT01061723|OG002|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
11001707|NCT01061723|OG003|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
11001708|NCT01061723|OG004|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
11001709|NCT01061723|OG005|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
11001710|NCT01061723|OG001|Outcome|Sarilumab 100mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
11001711|NCT01061723|OG002|Outcome|Sarilumab 150mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
11001712|NCT01061723|OG003|Outcome|Sarilumab 100mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
11001713|NCT01061723|OG004|Outcome|Sarilumab 200mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
11001714|NCT01061723|OG005|Outcome|Sarilumab 150mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
11001715|NCT01061723|EG000|Reported Event|Placebo|Placebo (for sarilumab) qw for 12 weeks.
11001716|NCT01061723|EG001|Reported Event|SAR153191 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
11001717|NCT01061723|EG002|Reported Event|SAR153191 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. Included a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.
11001718|NCT01061723|EG003|Reported Event|SAR153191 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
11001719|NCT01061723|EG004|Reported Event|SAR153191 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. Excluded a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.
11001720|NCT01061723|EG005|Reported Event|SAR153191 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
11001721|NCT01061736|BG000|Baseline|Part A: SAR 100 mg qw|Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
10877869|NCT00449644|BG002|Baseline|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
10877870|NCT00449644|BG003|Baseline|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
10877871|NCT00449644|BG004|Baseline|Total|Total of all reporting groups
10877872|NCT00449644|FG000|Participant Flow|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
10877873|NCT00449644|FG001|Participant Flow|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
10877874|NCT00449644|FG002|Participant Flow|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
10877875|NCT00449644|FG003|Participant Flow|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
10877876|NCT00449644|OG000|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
10877877|NCT00449644|OG001|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
10877878|NCT00449644|OG000|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
10877879|NCT00449644|OG001|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
10877880|NCT00449644|OG001|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week.
10877881|NCT00449644|OG000|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
10877882|NCT00449644|OG001|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
10877883|NCT00449644|EG000|Reported Event|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
10877884|NCT00449644|EG001|Reported Event|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
10877885|NCT00449644|EG002|Reported Event|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
10877886|NCT00449644|EG003|Reported Event|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
10877887|NCT00449670|BG000|Baseline|H5N1 Adjuvanted Group|Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
10877888|NCT00449670|BG001|Baseline|H5N1 Un-adjuvanted Group|Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
10877889|NCT00449670|BG002|Baseline|Total|Total of all reporting groups
10877890|NCT00449670|FG000|Participant Flow|H5N1 Adjuvanted Group|Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
11001722|NCT01061736|BG001|Baseline|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
11001723|NCT01061736|BG002|Baseline|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
11001724|NCT01061736|BG003|Baseline|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
11001725|NCT01061736|BG004|Baseline|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
11001726|NCT01061736|BG005|Baseline|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
11001727|NCT01061736|BG006|Baseline|Part B Cohort 1: Non-selected Doses|Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
11001728|NCT01061736|BG007|Baseline|Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
11001729|NCT01061736|BG008|Baseline|Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
11001730|NCT01061736|BG009|Baseline|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
11001731|NCT01061736|BG010|Baseline|Total|Total of all reporting groups
11001732|NCT01061736|FG000|Participant Flow|Part A: SAR 100 mg qw|Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of methotrexate (MTX) for 12 weeks.
11001733|NCT01061736|FG001|Participant Flow|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
11001734|NCT01061736|FG002|Participant Flow|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.
11001735|NCT01061736|FG003|Participant Flow|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
11001736|NCT01061736|FG004|Participant Flow|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
11001737|NCT01061736|FG005|Participant Flow|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
11001738|NCT01061736|FG006|Participant Flow|Part B Cohort 1: Non-selected Doses|Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
11001739|NCT01061736|FG007|Participant Flow|Part B: SAR 150 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)|Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
11001740|NCT01061736|FG008|Participant Flow|Part B: SAR 200 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)|Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
11001741|NCT01061736|FG009|Participant Flow|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
11001742|NCT01061736|OG000|Outcome|Part A: SAR 100 mg qw|Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
11001743|NCT01061736|OG001|Outcome|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
11001744|NCT01061736|OG002|Outcome|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
11001745|NCT01061736|OG003|Outcome|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
11001746|NCT01061736|OG004|Outcome|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
11001747|NCT01061736|OG005|Outcome|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
11001748|NCT01061736|OG000|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
11001749|NCT01061736|OG001|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
11001750|NCT01061736|OG002|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks
11001751|NCT01061736|OG002|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
11001752|NCT01061736|EG000|Reported Event|Part A: SAR 100 mg qw|Part A participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
11001753|NCT01061736|EG001|Reported Event|Part A: SAR 150 mg qw|Part A participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks).
11001754|NCT01061736|EG002|Reported Event|Part A: SAR 100 mg q2w|Part A participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 11 weeks).
11001755|NCT01061736|EG003|Reported Event|Part A: SAR 150 mg q2w|Part A participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 12 weeks). Included the participant randomized to placebo qw who received sarilumab 150 mg q2w in error.
11001756|NCT01061736|EG004|Reported Event|Part A: SAR 200 mg q2w|Part A participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 11 weeks).
11001757|NCT01061736|EG005|Reported Event|Part A: Placebo qw|Part A participants exposed to placebo on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received an erroneous IMP kit with sarilumab 150 mg q2w. He/she was considered in the 150 mg q2w treatment group for safety analysis.
11001758|NCT01061736|EG006|Reported Event|Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
11001759|NCT01061736|EG007|Reported Event|Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received sarilumab 100 mg q2w in error. He/she was considered in the 100 mg q2w treatment group for safety analysis.
11001760|NCT01061736|EG008|Reported Event|Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 13 weeks). Included 1 participant who received sarilumab 100 mg q2w in error.
11001761|NCT01061736|EG009|Reported Event|Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 42 weeks). 61 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Included 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error.
11001762|NCT01061736|EG010|Reported Event|Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 42 weeks). 55 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error and included a participant randomized to placebo q2w who received sarilumab 200 mg q2w in error.
11001763|NCT01061736|EG011|Reported Event|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to placebo q2w on top of MTX (mean exposure of 40 weeks). 168 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 1 participant randomized to placebo q2w who received sarilumab 200 mg q2w in error. He/she was considered in the 200 mg q2w treatment group for safety analysis.
11001764|NCT01061736|EG012|Reported Event|Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2|Part B participants exposed to sarilumab 150 mg q2w or 200 mg q2w or placebo q2w, without adequate response from Week 16, rescued with high dose of sarilumab (SAR 200 mg q2w) (mean exposure of 49 weeks from beginning of randomization to the end of rescue treatment).
11007719|NCT01092637|FG001|Participant Flow|Non-cooled|"Child was allocated standard intensive care only within 6 hours of birth. Normothermia was maintained throughout.~Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.~Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.~Psychologist completed the following tests:~Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)~NEPSY II selected sub-tests~Working Memory Test Battery for Children (WMTB-C)~Assessors were blinded to original trial treatment allocation."
11007720|NCT01092637|OG000|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
11007721|NCT01092637|OG001|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization to original trial. See full description in Participant flow section.
11007722|NCT01092637|OG001|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
11007723|NCT01092637|EG000|Reported Event|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
11007724|NCT01092637|EG001|Reported Event|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
11007725|NCT01092663|BG000|Baseline|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
11007726|NCT01092663|BG001|Baseline|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
11007727|NCT01092663|BG002|Baseline|Total|Total of all reporting groups
11007728|NCT01092663|FG000|Participant Flow|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
11007729|NCT01092663|FG001|Participant Flow|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
11007730|NCT01092663|OG000|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
11007731|NCT01092663|OG001|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.~Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
11007732|NCT01092663|OG001|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
11007733|NCT01092663|OG001|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.~Sitagliptin: Subjects were given 100 mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
11007734|NCT01092663|OG000|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
11007735|NCT01092663|OG001|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
10846630|NCT00278629|OG000|Outcome|Hematopoietic Stem Cell Transplantation for CIDP|Autologous hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide 200 mg/kg/intravenously(IV), rATG(thymoglobulin) 5.5 mg/kg/IV and rituximab 1000mg/IV
11007736|NCT01092663|OG001|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
11007737|NCT01092663|EG000|Reported Event|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
11224064|NCT02357576|EG000|Reported Event|Reduced Lipid|"Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition.~Intralipid 20% I.V. Fat Emulsion"
11001765|NCT01061775|BG000|Baseline|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
11001766|NCT01061775|FG000|Participant Flow|Exenatide|Participants received 5mcg of exenatide twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
11001767|NCT01061775|OG000|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
11001768|NCT01061775|OG000|Outcome|Exenatide|"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.~Of 55 potential participants screened, 19 agreed to participate. Reasons for decline included reluctance to add another medication to their current regimens, travel distance, and aversion to an injectable medication. Sixteen patients completed the study. Of the three who failed to complete the study, one was lost to follow up, and two dropped out due to difficulty adhering to the twice daily injections, but none experienced significant side effects from therapy. Three of the 19 patients were on chronic metformin therapy."
11001769|NCT01061775|EG000|Reported Event|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
11001770|NCT01061866|BG000|Baseline|Thalidomide|Tablets thalidomide at 200 mg dosage 100 mg in the morning and 100 mg in the night was administered daily during a twelve month period.
11001771|NCT01061866|FG000|Participant Flow|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
11001772|NCT01061866|OG000|Outcome|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
11001773|NCT01061866|EG000|Reported Event|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
11001774|NCT01062009|BG000|Baseline|Control Group|No intervention
11001775|NCT01062009|BG001|Baseline|Low Dose Group|"250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001776|NCT01062009|BG002|Baseline|Medium Dose Group|"500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001777|NCT01062009|BG003|Baseline|High Dose Group|"750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11224065|NCT02357576|EG001|Reported Event|Standard Lipid|"Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition.~Intralipid 20% I.V. Fat Emulsion"
11001778|NCT01062009|BG004|Baseline|Total|Total of all reporting groups
11001779|NCT01062009|FG000|Participant Flow|Control Group|No intervention
11001780|NCT01062009|FG001|Participant Flow|Low Dose Group|"250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001781|NCT01062009|FG002|Participant Flow|Medium Dose Group|"500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001782|NCT01062009|FG003|Participant Flow|High Dose Group|"750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001783|NCT01062009|OG000|Outcome|Control Group|No intervention
11001784|NCT01062009|OG001|Outcome|Low Dose Group|"250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001785|NCT01062009|OG002|Outcome|Medium Dose Group|"500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001786|NCT01062009|OG003|Outcome|High Dose Group|"750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001787|NCT01062009|EG000|Reported Event|Control Group|No intervention
11001788|NCT01062009|EG001|Reported Event|Low Dose Group|"250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001789|NCT01062009|EG002|Reported Event|Medium Dose Group|"500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001790|NCT01062009|EG003|Reported Event|High Dose Group|"750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days~Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline"
11001791|NCT01062061|BG000|Baseline|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
11001792|NCT01062061|FG000|Participant Flow|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
11001793|NCT01062061|OG000|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
11001794|NCT01062061|OG000|Outcome|Male Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
11001795|NCT01062061|OG001|Outcome|Female Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
11001796|NCT01062061|OG000|Outcome|Age <2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
11001797|NCT01062061|OG001|Outcome|Age ≥2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
11001798|NCT01062061|EG000|Reported Event|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
11001799|NCT01062074|BG000|Baseline|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
11001800|NCT01062074|FG000|Participant Flow|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
11001801|NCT01062074|OG000|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
11001802|NCT01062074|EG000|Reported Event|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
11001803|NCT01062113|BG000|Baseline|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
11001804|NCT01062113|BG001|Baseline|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11001805|NCT01062113|BG002|Baseline|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11001806|NCT01062113|BG003|Baseline|Total|Total of all reporting groups
11001807|NCT01062113|FG000|Participant Flow|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
11001808|NCT01062113|FG001|Participant Flow|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11001809|NCT01062113|FG002|Participant Flow|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11001810|NCT01062113|OG000|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11001811|NCT01062113|OG001|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11001812|NCT01062113|OG000|Outcome|Additional Dose Celecoxib 200mg|Included participants who received Celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11001813|NCT01062113|EG000|Reported Event|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
11001814|NCT01062113|EG001|Reported Event|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11001815|NCT01062113|EG002|Reported Event|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
11336495|NCT03567252|BG000|Baseline|Walking Group|"Participants in this group will join an established walking group and travel by foot 1 kilometer to a local Farmer's Market. They will also receive handouts about nutrition information and nutritional choices.~Walking Group: Participants will walk 1 kilometer to a Farmer's Market."
11001816|NCT01062126|BG000|Baseline|All Subjects Enrolled in the Study|All subjects that were enrolled in the study.
11001817|NCT01062126|FG000|Participant Flow|All Subjects Enrolled in the Study|Patients implanted with an SJM Accent SR/DR, Accent SR/DR RF, Anthem CRT-P, Anthem CRT-P RF, or newer SJM pacemaker device
11001818|NCT01062126|OG000|Outcome|All Subjects Enrolled in the Study|All subjects that were enrolled in the study.
11001819|NCT01062126|EG000|Reported Event|All Subjects Enrolled in the Study|All subjects that were enrolled in the study.
11001820|NCT01062165|BG000|Baseline|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
11001821|NCT01062165|FG000|Participant Flow|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
11001822|NCT01062165|OG000|Outcome|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
11001823|NCT01062165|EG000|Reported Event|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
11001824|NCT01062230|BG000|Baseline|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
11001825|NCT01062230|FG000|Participant Flow|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
11001826|NCT01062230|OG000|Outcome|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
11001827|NCT01062230|EG000|Reported Event|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
11001828|NCT01062256|BG000|Baseline|Placebo|One placebo tablet administered orally as a single dose
11001829|NCT01062256|BG001|Baseline|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
11001830|NCT01062256|BG002|Baseline|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
11001831|NCT01062256|BG003|Baseline|Total|Total of all reporting groups
11001832|NCT01062256|FG000|Participant Flow|Placebo|One placebo tablet administered orally as a single dose
11001833|NCT01062256|FG001|Participant Flow|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
11001834|NCT01062256|FG002|Participant Flow|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
11001835|NCT01062256|OG000|Outcome|Placebo|One placebo tablet administered orally as a single dose
11001836|NCT01062256|OG001|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
11001837|NCT01062256|OG002|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
11001838|NCT01062256|EG000|Reported Event|Placebo|One placebo tablet administered orally as a single dose
11001839|NCT01062256|EG001|Reported Event|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
11001840|NCT01062256|EG002|Reported Event|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
11001841|NCT01062269|BG000|Baseline|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
11001842|NCT01062269|FG000|Participant Flow|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
11001843|NCT01062269|OG000|Outcome|Cholestyramine 4 Grams|
11001844|NCT01062269|OG001|Outcome|Cholestyramine 12 Grams|
11001845|NCT01062269|OG002|Outcome|Tang|
11001846|NCT01062269|EG000|Reported Event|Cholestyramine 4 Grams|
11001847|NCT01062269|EG001|Reported Event|Cholestyramine 12 Grams|
11001848|NCT01062269|EG002|Reported Event|Tang|
11001849|NCT01062308|BG000|Baseline|Taping|Procedure for preventing shoulder injury
11001850|NCT01062308|BG001|Baseline|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
11001851|NCT01062308|BG002|Baseline|Total|Total of all reporting groups
11001852|NCT01062308|FG000|Participant Flow|Taping|Procedure for preventing shoulder injury
11001853|NCT01062308|FG001|Participant Flow|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
11001854|NCT01062308|OG000|Outcome|Taping|Procedure for preventing shoulder injury
11001855|NCT01062308|OG001|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
11001856|NCT01062308|EG000|Reported Event|Taping|Procedure for preventing shoulder injury
11001857|NCT01062308|EG001|Reported Event|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
11001858|NCT01062555|BG000|Baseline|Arm1 (Phase 1 & 2)|Participants from Phase 1, Arm 1 (CSA and MMF) and participants from Phase 2, Arm 1 (Low CNI and MMF)
11001859|NCT01062555|BG001|Baseline|Arm 2 (Phase 1 & 2)|Participants from Phase 1, Arm 2 (FK and MMF) and participants from Phase 2, Arm 2 (Rapa and MMF)
11001860|NCT01062555|BG002|Baseline|Total|Total of all reporting groups
11001861|NCT01062555|FG000|Participant Flow|Phase I Arm 1|"CSA and MMF~Cyclosporine & Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001862|NCT01062555|FG001|Participant Flow|Phase I Arm 2|"FK and MMF~Prograf & Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001863|NCT01062555|FG002|Participant Flow|Phase II Arm 1|"Low CNI and MMF~Low Dose CNI (Cyclosporine or FK) and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001864|NCT01062555|FG003|Participant Flow|Phase II Arm 2|"Rapa and MMF~Rapamune and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001865|NCT01062555|OG000|Outcome|Phase I Arm 1|"CSA and MMF~Cyclosporine & Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001866|NCT01062555|OG001|Outcome|Phase I Arm 2|"FK and MMF~Prograf & Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001867|NCT01062555|OG000|Outcome|Phase II Arm 1|"Low CNI and MMF~Low Dose CNI (Cyclosporine or FK) and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001868|NCT01062555|OG001|Outcome|Phase II Arm 2|"Rapa and MMF~Rapamune and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001869|NCT01062555|EG000|Reported Event|Phase I Arm 1|"CSA and MMF~Cyclosporine & Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001870|NCT01062555|EG001|Reported Event|Phase I Arm 2|"FK and MMF~Prograf & Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001871|NCT01062555|EG002|Reported Event|Phase II Arm 1|"Low CNI and MMF~Low Dose CNI (Cyclosporine or FK) and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001872|NCT01062555|EG003|Reported Event|Phase II Arm 2|"Rapa and MMF~Rapamune and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs."
11001873|NCT01062568|BG000|Baseline|Early Puberty Group|"Subjects were subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.~Dex"
10877891|NCT00449670|FG001|Participant Flow|H5N1 Un-adjuvanted Group|Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
10877892|NCT00449670|OG000|Outcome|H5N1 Adjuvanted Group - Lot 1|Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
10877893|NCT00449670|OG001|Outcome|H5N1 Adjuvanted Group - Lot 2|Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
10877894|NCT00449670|OG002|Outcome|H5N1 Adjuvanted Group - Lot 3|Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
10877895|NCT00449670|OG003|Outcome|H5N1 Adjuvanted Group - Lot 4|Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
10877896|NCT00449670|OG004|Outcome|H5N1 Un-adjuvanted Group|Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
10877897|NCT00449670|OG000|Outcome|H5N1 Adjuvanted Group|Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
10877898|NCT00449670|OG001|Outcome|H5N1 Un-adjuvanted Group|Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
10877899|NCT00449670|OG004|Outcome|H5N1 Un-Adjuvanted Group - Lot 1|Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
10877900|NCT00449670|OG005|Outcome|H5N1 Un-Adjuvanted Group - Lot 2|Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
10877901|NCT00449670|EG000|Reported Event|H5N1 Adjuvanted Group|Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
10877902|NCT00449670|EG001|Reported Event|H5N1 Un-adjuvanted Group|Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
10877903|NCT00449696|BG000|Baseline|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
10877904|NCT00449696|BG001|Baseline|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
10877905|NCT00449696|BG002|Baseline|Total|Total of all reporting groups
10877906|NCT00449696|FG000|Participant Flow|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
10877907|NCT00449696|FG001|Participant Flow|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
10877908|NCT00449696|OG000|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
10877909|NCT00449696|OG001|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
10877910|NCT00449696|EG000|Reported Event|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
10877911|NCT00449696|EG001|Reported Event|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
10877912|NCT00449748|BG000|Baseline|RAD001|Oral RAD001 10 mg daily for 30 days
10877913|NCT00449748|FG000|Participant Flow|RAD001|Oral RAD001 10 mg daily for 30 days
10877914|NCT00449748|OG000|Outcome|RAD001|Oral RAD001 10 mg daily for 30 days
10877915|NCT00449748|EG000|Reported Event|RAD001|Oral RAD001 10 mg daily for 30 days
11336496|NCT03567252|BG001|Baseline|Non-Walking Group|Participants in this group will have no walking requirement. They will receive handouts about nutrition information and nutritional choices.
11336497|NCT03567252|BG002|Baseline|Total|Total of all reporting groups
11001874|NCT01062568|BG001|Baseline|Late Puberty Group|"Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.~Dex"
11001875|NCT01062568|BG002|Baseline|Total|Total of all reporting groups
11001876|NCT01062568|FG000|Participant Flow|Early Puberty Group|"Subjects were subdivided into normal weight and overweight groups. Blood was drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take a oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements."
11001877|NCT01062568|FG001|Participant Flow|Late Puberty Group|"Subjects were subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.~Dex"
11001878|NCT01062568|OG000|Outcome|Early Puberty Group|Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
11001879|NCT01062568|OG001|Outcome|Late Puberty Group|Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
11001880|NCT01062568|OG002|Outcome|Total Number|"Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.~Dex"
11001881|NCT01062568|OG000|Outcome|Early Puberty Group|"Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this , adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements."
11001882|NCT01062568|OG001|Outcome|Late Puberty Group|"Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this , adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements."
11001883|NCT01062568|OG000|Outcome|Early Puberty|"Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this , adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements."
11001884|NCT01062568|OG001|Outcome|Late Puberty|"Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this , adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone . At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements."
11001885|NCT01062568|EG000|Reported Event|Early Puberty|"Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.~."
11001886|NCT01062568|EG001|Reported Event|Late Puberty|"Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.~Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements."
11001887|NCT01062763|BG000|Baseline|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~placebo : addition of placebo 1 to 2 tablets daily~spironolactone : 25 to 50 mg once daily"
11001888|NCT01062763|BG001|Baseline|Placebo|
11001889|NCT01062763|BG002|Baseline|Total|Total of all reporting groups
11001890|NCT01062763|FG000|Participant Flow|Placebo|1tablet of matching placebo trated up to 2 if neccessary
11001891|NCT01062763|FG001|Participant Flow|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~placebo : addition of placebo 1 to 2 tablets daily~spironolactone : 25 to 50 mg once daily"
11001892|NCT01062763|OG000|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
11001893|NCT01062763|OG001|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
11001894|NCT01062763|EG000|Reported Event|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
11001895|NCT01062763|EG001|Reported Event|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
11001896|NCT01062841|BG000|Baseline|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
11001897|NCT01062841|BG001|Baseline|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
11001898|NCT01062841|BG002|Baseline|Total|Total of all reporting groups
11001899|NCT01062841|FG000|Participant Flow|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) monthly using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
11001900|NCT01062841|FG001|Participant Flow|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. Surveillance cultures and data was collected for outcome comparison only.
11001901|NCT01062841|OG000|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
11001902|NCT01062841|OG001|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
11001903|NCT01062841|EG000|Reported Event|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
11001904|NCT01062841|EG001|Reported Event|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
11001905|NCT01062893|BG000|Baseline|0 Mls Saline Injected|"NO SALINE INJECTED~Sterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor."
11001906|NCT01062893|BG001|Baseline|15 Mls Saline|"15ML SALINE ADMINISTERED EPIDURALLY~15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications."
11001907|NCT01062893|BG002|Baseline|Total|Total of all reporting groups
11001908|NCT01062893|FG000|Participant Flow|0 Mls Saline Injected|"NO SALINE INJECTED~Sterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor."
11001909|NCT01062893|FG001|Participant Flow|15 Mls Saline|"15ML SALINE ADMINISTERED EPIDURALLY~15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications."
11224066|NCT02357706|BG000|Baseline|All Study Participants|"Patients will be randomised to either APAP A, then APAP B or APAP B, then APAP A. Patients in APAP A, then APAP B will use APAP A on the first night of the evaluation, and APAP B on the second night. Patients in APAP B, then APAP A will use APAP B on the first night of the evaluation and APAP A on the second night.~APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events~APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events"
11224067|NCT02357706|FG000|Participant Flow|APAP A, Then APAP B|"Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.~APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events~APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events"
11224068|NCT02357706|FG001|Participant Flow|APAP B, Then APAP A|"Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.~APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events~APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events"
11224069|NCT02357706|OG000|Outcome|APAP A (AirSense Auto Set)|"Patients in the APAP A, then APAP B group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.~APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events~APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events"
11224070|NCT02357706|OG001|Outcome|APAP B (Apex iCH Auto)|"Patients in the APAP B, then APAP A group will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.~APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events~APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events"
11336498|NCT03567252|FG000|Participant Flow|Walking Group|"Participants in this group will join an established walking group and travel by foot 1 kilometer to a local Farmer's Market. They will also receive handouts about nutrition information and nutritional choices.~Walking Group: Participants will walk 1 kilometer to a Farmer's Market."
11001910|NCT01062893|OG000|Outcome|0 Mls Saline Injected|"NO SALINE INJECTED~Sterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor."
11001911|NCT01062893|OG001|Outcome|15 Mls Saline|"15ML SALINE ADMINISTERED EPIDURALLY~15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications."
11001912|NCT01062893|EG000|Reported Event|0 Mls Saline Injected|"NO SALINE INJECTED~Sterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor."
11224071|NCT02357706|OG000|Outcome|APAP A (AirSense)|"Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.~APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events~APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events"
10877916|NCT00449761|BG000|Baseline|Panobinostat|Participants received panobinostat 20 mg orally OD, three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat was administered at the same time each morning, and with an 8oz/240 ml of water after a fasting period of at least two hours (water was allowed). Participants could continue this treatment until an unacceptable toxicity that precludes further treatment was experienced, or until disease progression.
10877917|NCT00449761|FG000|Participant Flow|Panobinostat|Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat was administered at the same time each morning, and with an 8oz/240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed). Participants could continue this treatment until an unacceptable toxicity that precludes further treatment was experienced, or until disease progression.
10877918|NCT00449761|OG000|Outcome|Panobinostat|Participants received panobinostat 20 mg orally OD, three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat was administered at the same time each morning, and with an 8oz/240 ml of water after a fasting period of at least two hours (water was allowed). Participants could continue this treatment until an unacceptable toxicity that precludes further treatment was experienced, or until disease progression.
10877919|NCT00449761|OG000|Outcome|Panobinostat|Participants received panobinostat 20 mg orally OD, three times a week as part of a 4 week (28 day). Panobinostat was administered at the same time each morning, and with an 240 ml of water after a fasting period of at least two hours (water was allowed). Participants could continue this treatment until an unacceptable toxicity that precludes further treatment was experienced, or until disease progression.
10877920|NCT00449761|EG000|Reported Event|Panobinostat|Participants received panobinostat 20 mg orally OD, three times a week as part of a 4 week (28 day). Panobinostat was administered at the same time each morning, and with an 240 ml of water after a fasting period of at least two hours (water was allowed). Participants could continue this treatment until an unacceptable toxicity that precludes further treatment was experienced, or until disease progression.
10877921|NCT00449787|BG000|Baseline|Sumatriptan|Sumatriptan 100 mg tablet
10877922|NCT00449787|BG001|Baseline|Naproxen|Naproxen 500 mg tablet
10877923|NCT00449787|BG002|Baseline|Total|Total of all reporting groups
10877924|NCT00449787|FG000|Participant Flow|Sumatriptan|Sumatriptan 100 mg tablet
10877925|NCT00449787|FG001|Participant Flow|Naproxen|Naproxen 500 mg tablet
10877926|NCT00449787|OG000|Outcome|Sumatriptan|Sumatriptan 100mg tablet
10877927|NCT00449787|OG001|Outcome|Naproxen|Naproxen 500mg tablet
10877928|NCT00449787|OG000|Outcome|Sumatriptan|Sumatriptan 100 mg tablet
10877929|NCT00449787|OG001|Outcome|Naproxen|Naproxen 500 mg tablet
10877930|NCT00449787|EG000|Reported Event|Sumatriptan|Sumatriptan 100 mg tablet
10877931|NCT00449787|EG001|Reported Event|Naproxen|Naproxen 500 mg tablet
10877932|NCT00449865|BG000|Baseline|Placebo|placebo: an inactive substance
10877933|NCT00449865|BG001|Baseline|Creatine|creatine 5 grams twice daily
10877934|NCT00449865|BG002|Baseline|Total|Total of all reporting groups
10877935|NCT00449865|FG000|Participant Flow|Placebo|placebo: an inactive substance
10877936|NCT00449865|FG001|Participant Flow|Creatine|creatine monohydrate (10 gram /day)
10877937|NCT00449865|OG000|Outcome|Placebo|placebo: an inactive substance
10877938|NCT00449865|OG001|Outcome|Creatine|creatine monohydrate (10 grams/day)
10877939|NCT00449865|EG000|Reported Event|Placebo|placebo: an inactive substance
10877940|NCT00449865|EG001|Reported Event|Creatine|creatine 5 grams twice daily
10877941|NCT00449930|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
10877942|NCT00449930|BG001|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
10877943|NCT00449930|BG002|Baseline|Total|Total of all reporting groups
10877944|NCT00449930|FG000|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
10877945|NCT00449930|FG001|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
10877946|NCT00449930|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
10877947|NCT00449930|OG001|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
10877948|NCT00449930|EG000|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
10877949|NCT00449930|EG001|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
10877950|NCT00449956|BG000|Baseline|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
11001913|NCT01062893|EG001|Reported Event|15 Mls Saline|"15ML SALINE ADMINISTERED EPIDURALLY~15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications."
11001914|NCT01062971|BG000|Baseline|A (Triple Therapy)|Dorzolamide-Timolol-Brimonidine group
11001915|NCT01062971|BG001|Baseline|B (Doble Therapy)|dorzolamide-timolol group
11001916|NCT01062971|BG002|Baseline|Total|Total of all reporting groups
11001917|NCT01062971|FG000|Participant Flow|A (Triple Therapy)|Dorzolamide-Timolol-Brimonidine group
11001918|NCT01062971|FG001|Participant Flow|B (Doble Therapy)|dorzolamide-timolol group
11001919|NCT01062971|OG000|Outcome|A (Triple Therapy)|Dorzolamide-Timolol-Brimonidine group
11001920|NCT01062971|OG001|Outcome|B (Doble Therapy)|dorzolamide-timolol group
11001921|NCT01062971|EG000|Reported Event|A (Triple Therapy)|Dorzolamide-Timolol-Brimonidine group
11001922|NCT01062971|EG001|Reported Event|B (Doble Therapy)|dorzolamide-timolol group
11001923|NCT01063036|BG000|Baseline|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
11001924|NCT01063036|FG000|Participant Flow|Entecavir + Tenofovir|"Entecavir (ETV) : Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
11001925|NCT01063036|OG000|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
11224072|NCT02357706|OG001|Outcome|APAP B (Apex)|"Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.~APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events~APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events"
11001926|NCT01063036|EG000|Reported Event|Entecavir + Tenofovir|Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks
11001927|NCT01063049|BG000|Baseline|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
11001928|NCT01063049|BG001|Baseline|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
11001929|NCT01063049|BG002|Baseline|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
11001930|NCT01063049|BG003|Baseline|Total|Total of all reporting groups
11001931|NCT01063049|FG000|Participant Flow|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
11001932|NCT01063049|FG001|Participant Flow|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
11001933|NCT01063049|FG002|Participant Flow|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
11336499|NCT03567252|FG001|Participant Flow|Non-Walking Group|Participants in this group will have no walking requirement. They will receive handouts about nutrition information and nutritional choices.
11001934|NCT01063049|OG000|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
11001935|NCT01063049|OG001|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
11001936|NCT01063049|OG002|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
11001937|NCT01063049|EG000|Reported Event|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
11001938|NCT01063049|EG001|Reported Event|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
11001939|NCT01063049|EG002|Reported Event|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
11001940|NCT01063062|BG000|Baseline|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
11001941|NCT01063062|BG001|Baseline|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
11001942|NCT01063062|BG002|Baseline|Total|Total of all reporting groups
11001943|NCT01063062|FG000|Participant Flow|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
11001944|NCT01063062|FG001|Participant Flow|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
11001945|NCT01063062|OG000|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
11001946|NCT01063062|OG001|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
11001947|NCT01063062|OG000|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
11001948|NCT01063062|EG000|Reported Event|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
11001949|NCT01063062|EG001|Reported Event|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
11001950|NCT01063075|BG000|Baseline|All Participants (Group A, B, C and D)|"Group D:~Cycle 1:400 mg/m² cetuximab week (w) 1,day(d) 1.Carboplatin(AUC=5) on w 1, d 1.Optional 1000 mg/m²/d 5-FU given as a 96-hour C.I. starting(strt) on w 1, d 1.~Group C:~Cycle 1:Carboplatin(AUC=5) on w 1,d 1. 400 mg/m² cetuximab on w 2, d 1.Cetuximab 250 mg/m ² on w 3 and 4, d 1.~Cycle 2-6:Carboplatin(AUC=5) and 250 mg/m² cetuximab on w 1, d 1.1000 mg/m²/d 5-FU given as a 96-hour C.I. strt on w 1, d 1.250 mg/m² cetuximab on w 2 and 3, d 1.~Group B:~Cycle 1:400 mg/m² cetuximab on w 1, d 1. 250 mg/m ² cetuximab on w 2 and 3, d 1.~Cycle 2:Carboplatin(AUC=5) w 1, d 1.1000 mg/m ²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m ² cetuximab w 1- 3, d 1.~Group A:~Cycle 1:Carboplatin(AUC=5) on w 1, d 1. 1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1.~400 mg/m² cetuximab on w 2, d 1 and 250 mg/m² cetuximab on w 3, d 1. Cycle 2:Carboplatin(AUC=5) given I.V on w 1, d 1.1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m² cetuximab on w 1-3, d 1."
11001951|NCT01063075|FG000|Participant Flow|Carboplatin and Cetuximab (A)|"Group A:~Cycle 1 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 milligrams per square meter (mg/m ²) cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
11001952|NCT01063075|FG001|Participant Flow|Cetuximab and Carboplatin (B)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
11001953|NCT01063075|FG002|Participant Flow|Cetuximab and Carboplatin (C)|"Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
11001954|NCT01063075|FG003|Participant Flow|Cetuximab and Carboplatin (D)|"Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
11001955|NCT01063075|OG000|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
11001956|NCT01063075|OG000|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
11001957|NCT01063075|OG001|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
11007738|NCT01092663|EG001|Reported Event|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
11001958|NCT01063075|OG000|Outcome|Cetuximab (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
11001959|NCT01063075|EG000|Reported Event|Carboplatin and Cetuximab (A)|"Group A:~Cycle 1 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
11001960|NCT01063075|EG001|Reported Event|Carboplatin and Cetuximab (B)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
11001961|NCT01063075|EG002|Reported Event|Carboplatin and Cetuximab (C)|"Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
11001962|NCT01063075|EG003|Reported Event|Carboplatin and Cetuximab (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on day 1. Carboplatin area under the curve (AUC=5) administered I.V on day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on day 1."
11001963|NCT01063153|BG000|Baseline|Control|Subjects without ADHD
11001964|NCT01063153|BG001|Baseline|ADHD|Subjects with ADHD
11001965|NCT01063153|BG002|Baseline|Total|Total of all reporting groups
11001966|NCT01063153|FG000|Participant Flow|Control|Controls without ADHD were assessed using EEG
11001967|NCT01063153|FG001|Participant Flow|ADHD|Subjects with ADHD were assessed with EEG before and after treatment with Concerta
11001968|NCT01063153|OG000|Outcome|ADHD|Subjects with ADHD were assessed before and after treatment.
11001969|NCT01063153|OG001|Outcome|Controls|Controls without ADHD were assessed with a one-time EEG, only.
11001970|NCT01063153|OG000|Outcome|ADHD and Visual NoGo Task|Participants with a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
11224475|NCT02360293|EG001|Reported Event|Stay Strong|"Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.~Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device."
11001971|NCT01063153|OG001|Outcome|Control Group and Visual NoGo Task|Participants without a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
11001972|NCT01063153|OG002|Outcome|ADHD and Visual Go Task|Participants with a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
11001973|NCT01063153|OG003|Outcome|Control Group and Visual Go Task|Participants without a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
11001974|NCT01063153|EG000|Reported Event|Control|Subjects without ADHD were assessed using EEG.
11001975|NCT01063153|EG001|Reported Event|ADHD|Subjects with ADHD were assessed with EEG before and after open-label treatment with Concerta.
11001976|NCT01063283|BG000|Baseline|Group A|Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
11001977|NCT01063283|BG001|Baseline|Group B|Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses
11001978|NCT01063283|BG002|Baseline|Total|Total of all reporting groups
11001979|NCT01063283|FG000|Participant Flow|All Participants|All participants enrolled received Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once during the first cycle.
11001980|NCT01063283|FG001|Participant Flow|Group A|Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once during first cycle, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
11001981|NCT01063283|FG002|Participant Flow|Group B|Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once during first cycle, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses
11001982|NCT01063283|OG000|Outcome|Group A|Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
11001983|NCT01063283|OG001|Outcome|Group B|Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses
11001984|NCT01063283|EG000|Reported Event|Group A|Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
11001985|NCT01063283|EG001|Reported Event|Group B|Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses
11001986|NCT01063348|BG000|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
10877951|NCT00449956|BG001|Baseline|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
10877952|NCT00449956|BG002|Baseline|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
10877953|NCT00449956|BG003|Baseline|Total|Total of all reporting groups
10877954|NCT00449956|FG000|Participant Flow|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
10877955|NCT00449956|FG001|Participant Flow|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
10877956|NCT00449956|FG002|Participant Flow|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
10877957|NCT00449956|OG000|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
10877958|NCT00449956|OG001|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
10877959|NCT00449956|OG002|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
10877960|NCT00449956|EG000|Reported Event|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
10877961|NCT00449956|EG001|Reported Event|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
10877962|NCT00449956|EG002|Reported Event|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
10877963|NCT00450073|BG000|Baseline|Vitamin D3|vitamin D3 50,000 IU weekly
10877964|NCT00450073|BG001|Baseline|Vitamin D2|vitamin D2 50,000 IU weekly
10877965|NCT00450073|BG002|Baseline|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks
10877966|NCT00450073|BG003|Baseline|Total|Total of all reporting groups
10877967|NCT00450073|FG000|Participant Flow|Vitamin D3|vitamin D3 50,000 IU weekly
10877968|NCT00450073|FG001|Participant Flow|Vitamin D2|vitamin D2 50,000 IU weekly
10877969|NCT00450073|FG002|Participant Flow|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks.
10877970|NCT00450073|OG000|Outcome|Vitamin D3|vitamin D3 50,000 IU weekly
10877971|NCT00450073|OG001|Outcome|Vitamin D2|vitamin D2 50,000 IU weekly
10877972|NCT00450073|OG002|Outcome|Sunlamp|Weekly use of a sunlamp
10877973|NCT00450073|EG000|Reported Event|Vitamin D3|vitamin D3 50,000 IU weekly
10877974|NCT00450073|EG001|Reported Event|Vitamin D2|vitamin D2 50,000 IU weekly
10877975|NCT00450073|EG002|Reported Event|Sunlamp|Weekly use of a sunlamp
10877976|NCT00450112|BG000|Baseline|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
10877977|NCT00450112|BG001|Baseline|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
10877978|NCT00450112|BG002|Baseline|Total|Total of all reporting groups
10877979|NCT00450112|FG000|Participant Flow|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
10877980|NCT00450112|FG001|Participant Flow|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
10877981|NCT00450112|OG000|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
10877982|NCT00450112|OG001|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
10877983|NCT00450112|EG000|Reported Event|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
10877984|NCT00450112|EG001|Reported Event|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
10877985|NCT00450177|BG000|Baseline|Iron Group|"Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.~Ferrous Sulfate: Iron group"
10877986|NCT00450177|BG001|Baseline|Placebo Group|"Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.~Placebo Oral Tablet: Placebo group"
10877987|NCT00450177|BG002|Baseline|Total|Total of all reporting groups
10877988|NCT00450177|FG000|Participant Flow|Iron Group|"Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.~Ferrous Sulfate: Iron group"
10877989|NCT00450177|FG001|Participant Flow|Placebo Group|"Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.~Placebo Oral Tablet: Placebo group"
11001987|NCT01063348|BG001|Baseline|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
10877990|NCT00450177|OG000|Outcome|Iron Group|"Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.~Ferrous Sulfate: Iron group"
10877991|NCT00450177|OG001|Outcome|Placebo Group|"Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.~Placebo Oral Tablet: Placebo group"
11001988|NCT01063348|BG002|Baseline|Total|Total of all reporting groups
11001989|NCT01063348|FG000|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
11001990|NCT01063348|FG001|Participant Flow|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
10877992|NCT00450177|EG000|Reported Event|Iron Group|"Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.~Ferrous Sulfate: Iron group"
10877993|NCT00450177|EG001|Reported Event|Placebo Group|"Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.~Placebo Oral Tablet: Placebo group"
10877994|NCT00450190|BG000|Baseline|Saizen® E-Device|Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) was administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
10877995|NCT00450190|FG000|Participant Flow|Saizen® E-Device|Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) was administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
10877996|NCT00450190|OG000|Outcome|Saizen® E-Device|Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) was administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
10877997|NCT00450190|EG000|Reported Event|Saizen® E-Device|Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) was administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
10877998|NCT00450216|BG000|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
10877999|NCT00450216|BG001|Baseline|Ibuprofen|Ibuprofen 800mg
10878000|NCT00450216|BG002|Baseline|Total|Total of all reporting groups
10878001|NCT00450216|FG000|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg tablets t.i.d.
10878002|NCT00450216|FG001|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
10878003|NCT00450216|OG000|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
10878004|NCT00450216|OG001|Outcome|Ibuprofen|Ibuprofen 800mg
10878005|NCT00450216|EG000|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
10878006|NCT00450216|EG001|Reported Event|Ibuprofen|Ibuprofen 800mg
10878007|NCT00450242|BG000|Baseline|5% Lidocaine Cream|5% topical lidocaine cream.
10878008|NCT00450242|BG001|Baseline|Placebo Cream|
10878009|NCT00450242|BG002|Baseline|Total|Total of all reporting groups
10878010|NCT00450242|FG000|Participant Flow|5% Lidocaine Cream|5% topical lidocaine cream.
10878011|NCT00450242|FG001|Participant Flow|Placebo Cream|
10878012|NCT00450242|OG000|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
10878013|NCT00450242|OG001|Outcome|Placebo Cream|Topical cream vehicle.
10878014|NCT00450242|OG001|Outcome|Placebo Cream|
10878015|NCT00450242|OG001|Outcome|Placebo Cream|topical cream vehicle.
10878016|NCT00450242|EG000|Reported Event|5% Lidocaine Cream|5% topical lidocaine cream.
10878017|NCT00450242|EG001|Reported Event|Placebo Cream|
10878018|NCT00450255|BG000|Baseline|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10878019|NCT00450255|FG000|Participant Flow|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10878020|NCT00450255|OG000|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10878021|NCT00450255|OG000|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10878022|NCT00450255|EG000|Reported Event|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
10878023|NCT00450294|BG000|Baseline|Longitudinal Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
11001991|NCT01063348|OG000|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
11001992|NCT01063348|OG001|Outcome|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
11336500|NCT03567252|OG000|Outcome|Walking Group|"Participants in this group will join an established walking group and travel by foot 1 kilometer to a local Farmer's Market. They will also receive handouts about nutrition information and nutritional choices.~Walking Group: Participants will walk 1 kilometer to a Farmer's Market."
10878024|NCT00450294|FG000|Participant Flow|Longitudinal Study Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.Measurement of Central venous pressure at event intervals during abdominal aortic aneurysm repair. Data are presented as mean +/- standard error.
10878025|NCT00450294|OG000|Outcome|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
10878026|NCT00450294|OG000|Outcome|Longitudinal Study Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair.
10878027|NCT00450294|EG000|Reported Event|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
10878028|NCT00450372|BG000|Baseline|Single Arm|
10878029|NCT00450372|FG000|Participant Flow|Single Arm|
10878030|NCT00450372|OG000|Outcome|ADI-PED 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with Argininosuccinate Synthetase (ASS) expression present in tumor
10878031|NCT00450372|OG001|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without Argininosuccinate Synthetase (ASS) expression present in tumor
10878032|NCT00450372|OG000|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
10878033|NCT00450372|OG001|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
10878034|NCT00450372|EG000|Reported Event|Single Arm|
10878035|NCT00450385|BG000|Baseline|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
10878036|NCT00450385|FG000|Participant Flow|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
10878037|NCT00450385|OG000|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
10878038|NCT00450385|OG000|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days.~Rituximab: Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles~Cyclophosphamide: Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles~Doxorubicin: Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles~Prednisone: Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.~Vincristine: Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles"
10878039|NCT00450385|EG000|Reported Event|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
10878040|NCT00450424|BG000|Baseline|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
10878041|NCT00450424|BG001|Baseline|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
10878042|NCT00450424|BG002|Baseline|Total|Total of all reporting groups
10878043|NCT00450424|FG000|Participant Flow|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
11001993|NCT01063348|EG000|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
11001994|NCT01063348|EG001|Reported Event|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
11001995|NCT01063595|BG000|Baseline|All Participants|Participants received 1200 mL of Octaplas LG intravenously once and 1200 mL of Octaplas SD intravenously once in a crossover design.
11001996|NCT01063595|FG000|Participant Flow|Octaplas SD First, Then Octaplas LG|Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once.
11001997|NCT01063595|FG001|Participant Flow|Octaplas LG First, Then Octaplas SD|Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once.
11001998|NCT01063595|OG000|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
11001999|NCT01063595|OG001|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
11002000|NCT01063595|EG000|Reported Event|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
11002001|NCT01063595|EG001|Reported Event|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
11002002|NCT01063712|BG000|Baseline|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
11002003|NCT01063712|FG000|Participant Flow|"Nit-Occlud® PDA-R Implantations Group"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have ducts in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
11002004|NCT01063712|OG000|Outcome|Closure in the Control Period|"The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."
11002005|NCT01063712|OG000|Outcome|Number of Patients With Complete Regression of Dilation|"Children born with patent arterial duct develop cardiac insufficiency early in life. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the duct on time. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method.~This group of patients had 2-8 mm ductus, haven´t developed pulmonary hypertension and have enough weight to be treated.~Patients with left to right shunt show a dilation of left ventricle and left atrium. The quotient Left atrium/aortic ring is a well known method to estimate the grade of the dilation of the left atrium. The M-Mode method, is useful to assessed the regression of the ventricle after the ducts is closed. These observations were made at the beginning of the study and after six months."
11002006|NCT01063712|EG000|Reported Event|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
11007739|NCT01092676|BG000|Baseline|Regular Ibuprofen Dosing|"Regular Ibuprofen Dosing throughout 4 days of study~Ibuprofen Regular Dosing: Regular dosing"
11007740|NCT01092676|BG001|Baseline|PRN Ibuprofen Dosing|"As needed Ibuprofen dosing~PRN dosing Ibuprofen: PRN dosing Ibupofen"
11007741|NCT01092676|BG002|Baseline|Total|Total of all reporting groups
11007742|NCT01092676|FG000|Participant Flow|Regular Ibuprofen Dosing|"Regular Ibuprofen Dosing throughout 4 days of study~Ibuprofen Regular Dosing: Regular dosing"
11224476|NCT02360319|BG000|Baseline|Clinician's Choice|"Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years~Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients"
11336501|NCT03567252|OG001|Outcome|Non-Walking Group|Participants in this group will have no walking requirement. They will receive handouts about nutrition information and nutritional choices.
11007743|NCT01092676|FG001|Participant Flow|PRN Ibuprofen Dosing|"As needed Ibuprofen dosing~PRN dosing Ibuprofen: PRN dosing Ibupofen"
10845238|NCT00265785|BG000|Baseline|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
11007744|NCT01092676|OG000|Outcome|Regular Ibuprofen Dosing|"Regular Ibuprofen Dosing throughout 4 days of study~Ibuprofen Regular Dosing: Regular dosing"
11007745|NCT01092676|OG001|Outcome|PRN Ibuprofen Dosing|"As needed Ibuprofen dosing~PRN dosing Ibuprofen: PRN dosing Ibupofen"
11007746|NCT01092676|EG000|Reported Event|Regular Ibuprofen Dosing|"Regular Ibuprofen Dosing throughout 4 days of study~Ibuprofen Regular Dosing: Regular dosing"
10845239|NCT00265785|FG000|Participant Flow|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
10845240|NCT00265785|OG000|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
10845241|NCT00265785|EG000|Reported Event|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
10845242|NCT00265850|BG000|Baseline|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845243|NCT00265850|BG001|Baseline|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845244|NCT00265850|BG002|Baseline|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845245|NCT00265850|BG003|Baseline|Total|Total of all reporting groups
10845246|NCT00265850|FG000|Participant Flow|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845247|NCT00265850|FG001|Participant Flow|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845754|NCT00269477|EG000|Reported Event|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
10845755|NCT00269477|EG001|Reported Event|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
11002007|NCT01063764|BG000|Baseline|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
11002008|NCT01063764|FG000|Participant Flow|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
11002009|NCT01063764|OG000|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
11002010|NCT01063764|EG000|Reported Event|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
11002011|NCT01063829|BG000|Baseline|AIC246 (60 mg)|AIC246: Oral Administration
11002012|NCT01063829|BG001|Baseline|AIC246 (120 mg)|AIC246: Oral Administration
11002013|NCT01063829|BG002|Baseline|AIC246 (240 mg)|AIC246: Oral Administration
11002014|NCT01063829|BG003|Baseline|Placebo|Placebo: Oral Administration
11002015|NCT01063829|BG004|Baseline|Total|Total of all reporting groups
11002016|NCT01063829|FG000|Participant Flow|AIC246 (60 mg)|AIC246: Oral Administration
11002017|NCT01063829|FG001|Participant Flow|AIC246 (120 mg)|AIC246: Oral Administration
11002018|NCT01063829|FG002|Participant Flow|AIC246 (240 mg)|AIC246: Oral Administration
11002019|NCT01063829|FG003|Participant Flow|Placebo|Placebo: Oral Administration
11002020|NCT01063829|OG000|Outcome|AIC246 (60 mg)|AIC246: Oral Administration
11002021|NCT01063829|OG001|Outcome|AIC246 (120 mg)|AIC246: Oral Administration
11002022|NCT01063829|OG002|Outcome|AIC246 (240 mg)|AIC246: Oral Administration
11002023|NCT01063829|OG003|Outcome|Placebo|Placebo: Oral Administration
11002024|NCT01063829|EG000|Reported Event|AIC246 (60 mg)|AIC246: Oral Administration
11002025|NCT01063829|EG001|Reported Event|AIC246 (120 mg)|AIC246: Oral Administration
11002026|NCT01063829|EG002|Reported Event|AIC246 (240 mg)|AIC246: Oral Administration
11002027|NCT01063829|EG003|Reported Event|Placebo|Placebo: Oral Administration
11002028|NCT01063855|BG000|Baseline|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002029|NCT01063855|BG001|Baseline|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002030|NCT01063855|BG002|Baseline|Total|Total of all reporting groups
11002031|NCT01063855|FG000|Participant Flow|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002032|NCT01063855|FG001|Participant Flow|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002033|NCT01063855|OG000|Outcome|PDE5I + Placebo (Baseline)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002034|NCT01063855|OG001|Outcome|PDE5I + Placebo (Week 12)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002035|NCT01063855|OG002|Outcome|PDE5I + Dapoxetine (Baseline)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
11002036|NCT01063855|OG003|Outcome|PDE5I + Dapoxetine (Week 12)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
11002037|NCT01063855|OG000|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002038|NCT01063855|OG001|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002039|NCT01063855|EG000|Reported Event|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002040|NCT01063855|EG001|Reported Event|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
11002041|NCT01063868|BG000|Baseline|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
11002042|NCT01063868|BG001|Baseline|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
11002043|NCT01063868|BG002|Baseline|Total|Total of all reporting groups
11002044|NCT01063868|FG000|Participant Flow|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
11002045|NCT01063868|FG001|Participant Flow|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
11002046|NCT01063868|OG000|Outcome|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
11002047|NCT01063868|OG001|Outcome|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
11002048|NCT01063868|EG000|Reported Event|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
11002049|NCT01063868|EG001|Reported Event|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
11002050|NCT01063881|BG000|Baseline|Dapoxetine 30 mg Only|144 of 147 patients took at least 1 dose of dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002051|NCT01063881|BG001|Baseline|Dapoxetine 30 to 60 mg|124 of 125 patients took at least one dose of dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002052|NCT01063881|BG002|Baseline|Dapoxetine 30 to 60 to 30 mg|13 patients took at least one dose of dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002053|NCT01063881|BG003|Baseline|Total|Total of all reporting groups
11002054|NCT01063881|FG000|Participant Flow|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002055|NCT01063881|FG001|Participant Flow|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002056|NCT01063881|FG002|Participant Flow|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002057|NCT01063881|OG000|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
11002058|NCT01063881|OG000|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
11002059|NCT01063881|OG001|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
11002060|NCT01063881|OG000|Outcome|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002061|NCT01063881|OG001|Outcome|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002062|NCT01063881|OG002|Outcome|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002063|NCT01063881|OG000|Outcome|Dapoxetine (Patients With Life-long PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
11002064|NCT01063881|OG001|Outcome|Dapoxetine (Patients With Acquired PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
11002065|NCT01063881|OG000|Outcome|Dapoxetine (Patients With IELT <1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
11002066|NCT01063881|OG001|Outcome|Dapoxetine (Patients With IELT >1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
11002067|NCT01063881|EG000|Reported Event|Depoxetine (DPX) 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002068|NCT01063881|EG001|Reported Event|Depoxetine (DPX) 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002069|NCT01063881|EG002|Reported Event|Depoxetine (DPX) 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
11002070|NCT01063907|BG000|Baseline|KW-2478 and Bortezomib|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and Bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2 / Bortezomib 1.3 mg/m^2)."
11002071|NCT01063907|FG000|Participant Flow|Phase 1: KW-2478 and Bortezomib|"The target population in Phase 1 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts."
11002072|NCT01063907|FG001|Participant Flow|Phase II: KW-2478 130mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in Phase 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For the Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and bortezomib at the RP2D (KW-2478 175 mg/m^2/bortezomib1.3 mg/m^2)."
11002073|NCT01063907|OG000|Outcome|Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m^2) and Bortezomib (1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.~The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2)."
11002074|NCT01063907|OG001|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002075|NCT01063907|OG002|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002076|NCT01063907|OG003|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002077|NCT01063907|OG004|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002078|NCT01063907|OG005|Outcome|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2).
11002079|NCT01063907|OG000|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
11002080|NCT01063907|OG001|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
11002081|NCT01063907|OG002|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
11002082|NCT01063907|OG003|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
11002083|NCT01063907|OG000|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002084|NCT01063907|OG001|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11007747|NCT01092676|EG001|Reported Event|PRN Ibuprofen Dosing|"As needed Ibuprofen dosing~PRN dosing Ibuprofen: PRN dosing Ibupofen"
11002085|NCT01063907|OG002|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002086|NCT01063907|OG003|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002087|NCT01063907|EG000|Reported Event|Phase 1 and 2: KW-2478 and Bortezomib|KW-2478 and bortezomib: KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle
11002088|NCT01063907|EG001|Reported Event|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002089|NCT01063907|EG002|Reported Event|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002090|NCT01063907|EG003|Reported Event|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002091|NCT01063907|EG004|Reported Event|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
11002092|NCT01063907|EG005|Reported Event|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 + BTZ at the RP2D (KW-2478 175 mg/m^2/BTZ 1.3 mg/m^2).
11002093|NCT01063972|BG000|Baseline|Centralized Disease Management (CDM)|"Experimental: 1 Centralized disease management~Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider"
11002094|NCT01063972|BG001|Baseline|Counseling (C)|"Experimental: 2 Counseling alone~Counseling (C): Counseling (C) arm will receive counseling without the care coordination services."
11002095|NCT01063972|BG002|Baseline|Total|Total of all reporting groups
11002096|NCT01063972|FG000|Participant Flow|Centralized Disease Management (CDM)|"Experimental: 1 Centralized disease management~Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider"
11002097|NCT01063972|FG001|Participant Flow|Counseling (C)|"Experimental: 2 Counseling alone~Counseling (C): Counseling (C) arm will receive counseling without the care coordination services."
11002098|NCT01063972|OG000|Outcome|Centralized Disease Management (CDM)|"Experimental: 1 Centralized disease management~Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider"
11002099|NCT01063972|OG001|Outcome|Counseling (C)|"Experimental: 2 Counseling alone~Counseling (C): Counseling (C) arm will receive counseling without the care coordination services."
11002100|NCT01063972|EG000|Reported Event|Centralized Disease Management (CDM)|"Experimental: 1 Centralized disease management~Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider"
11002101|NCT01063972|EG001|Reported Event|Counseling (C)|"Experimental: 2 Counseling alone~Counseling (C): Counseling (C) arm will receive counseling without the care coordination services."
11002102|NCT01064076|BG000|Baseline|S-ICD System|This is a single arm study
11002103|NCT01064076|FG000|Participant Flow|S-ICD System|This is a single arm study
11002104|NCT01064076|OG000|Outcome|Single Arm|Cohort includes all subjects undergoing an implant attempt
11002105|NCT01064076|OG000|Outcome|S-ICD System|This is a single arm study
11224477|NCT02360319|BG001|Baseline|Aripiprazole Once Monthly|"Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years~aripiprazole long acting injectable formulation"
11002106|NCT01064076|EG000|Reported Event|S-ICD System|This is a single arm study
11002107|NCT01064167|BG000|Baseline|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
11002108|NCT01064167|BG001|Baseline|Control Group|The placebo consisted of an equivalent volume of saline solution.
11002109|NCT01064167|BG002|Baseline|Total|Total of all reporting groups
11002110|NCT01064167|FG000|Participant Flow|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
11002111|NCT01064167|FG001|Participant Flow|Control Group|The placebo consisted of an equivalent volume of saline solution.
11002112|NCT01064167|OG000|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
11002113|NCT01064167|OG001|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
11002114|NCT01064167|EG000|Reported Event|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
11002115|NCT01064167|EG001|Reported Event|Control Group|The placebo consisted of an equivalent volume of saline solution.
11002116|NCT01064284|BG000|Baseline|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11002117|NCT01064284|BG001|Baseline|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11002118|NCT01064284|BG002|Baseline|Total|Total of all reporting groups
11002119|NCT01064284|FG000|Participant Flow|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11002120|NCT01064284|FG001|Participant Flow|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11007748|NCT01092702|BG000|Baseline|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
11002121|NCT01064284|OG000|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11002122|NCT01064284|OG001|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11002123|NCT01064284|OG000|Outcome|PLASMA DERIVED Factor VIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11002124|NCT01064284|EG000|Reported Event|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11002125|NCT01064284|EG001|Reported Event|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
11002126|NCT01064297|BG000|Baseline|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
11002127|NCT01064297|BG001|Baseline|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
11002128|NCT01064297|BG002|Baseline|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
11002129|NCT01064297|BG003|Baseline|Total|Total of all reporting groups
11002130|NCT01064297|FG000|Participant Flow|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
11002131|NCT01064297|FG001|Participant Flow|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
11002132|NCT01064297|FG002|Participant Flow|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
11002133|NCT01064297|OG000|Outcome|First Exposure During First Trimester|The first trimester begins at conception
11002134|NCT01064297|OG001|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
11002135|NCT01064297|OG002|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
11002136|NCT01064297|OG003|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
11002137|NCT01064297|OG004|Outcome|All Trimesters|Exposure during any trimester of pregnancy
11002138|NCT01064297|OG000|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
11002139|NCT01064297|OG001|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
11002140|NCT01064297|OG002|Outcome|Dose Higher Than Prescribed|>400 mg/day maximal dose in first trimester
11002141|NCT01064297|OG003|Outcome|Unknown Maximal Dose in Exposed Trimester|
11002142|NCT01064297|OG002|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
11002143|NCT01064297|EG000|Reported Event|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
11002144|NCT01064297|EG001|Reported Event|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
11002145|NCT01064297|EG002|Reported Event|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
11002146|NCT01064310|BG000|Baseline|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
11002147|NCT01064310|BG001|Baseline|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
11002148|NCT01064310|BG002|Baseline|Total|Total of all reporting groups
11002149|NCT01064310|FG000|Participant Flow|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
11007749|NCT01092702|FG000|Participant Flow|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
11007750|NCT01092702|OG000|Outcome|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
11007751|NCT01092702|EG000|Reported Event|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
11224478|NCT02360319|BG002|Baseline|Total|Total of all reporting groups
11224073|NCT02357706|OG001|Outcome|APAP B|"Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.~APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events~APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events"
11224074|NCT02357706|EG000|Reported Event|APAP A (AirSense)|APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
11224075|NCT02357706|EG001|Reported Event|APAP B (Apex)|APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
11224076|NCT02357758|BG000|Baseline|Antibiotic Prophylaxis|"Patients with RUTI receiving Septra (Trimethoprim dose 2mg/kg) or nitrofurantoin (dose 2 mg/kg) as determined by clinician.~Antibiotic Prophylaxis"
11002150|NCT01064310|FG001|Participant Flow|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
11002151|NCT01064310|FG002|Participant Flow|Open Label Pazopinib|To provide continued access to treatment
11002152|NCT01064310|OG000|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
11002153|NCT01064310|OG001|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
11002154|NCT01064310|OG000|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
11002155|NCT01064310|OG001|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
11002156|NCT01064310|EG000|Reported Event|Sunitinib|Sunitinib
11002157|NCT01064310|EG001|Reported Event|Pazopanib|Pazopanib
11002158|NCT01064310|EG002|Reported Event|Open Label Pazopanib|Open Label Pazopanib
11002159|NCT01064323|BG000|Baseline|Intermittent Leg Compression|"Intermittent leg compression daily for 3 hrs a day for 4 weeks~Intermittent pneumatic compression of the lower extremities: IPC will be done for 3 divided hours daily for 4 weeks"
11002160|NCT01064323|FG000|Participant Flow|Intermittent Leg Compression|Intermittent leg compression for one hour.
11002161|NCT01064323|OG000|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
11002162|NCT01064323|EG000|Reported Event|Intermittent Leg Compression|Intermittent leg compression for one hour.
11002163|NCT01064362|BG000|Baseline|Fondaparinux|All dosages of fondaparinux
11002164|NCT01064362|BG001|Baseline|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
11002165|NCT01064362|BG002|Baseline|Total|Total of all reporting groups
11002166|NCT01064362|FG000|Participant Flow|Fondaparinux|All dosages of fondaparinux
11224077|NCT02357758|BG001|Baseline|Healthy Population|
11224078|NCT02357758|BG002|Baseline|Clinical Observation|Patients experiencing RUTI that do not require antibiotic prophylaxis as determined by clinician.
11224079|NCT02357758|BG003|Baseline|Total|Total of all reporting groups
11224080|NCT02357758|FG000|Participant Flow|Antibiotic Prophylaxis|"Patients with RUTI receiving Septra (Trimethoprim dose 2mg/kg) or nitrofurantoin (dose 2 mg/kg) as determined by clinician.~Antibiotic Prophylaxis"
11224081|NCT02357758|FG001|Participant Flow|Healthy Population|
11224082|NCT02357758|FG002|Participant Flow|Clinical Observation|Patients experiencing RUTI that do not require antibiotic prophylaxis as determined by clinician.
11224083|NCT02357758|OG000|Outcome|Antibiotic Prophylaxis|"Patients with RUTI receiving Septra (Trimethoprim dose 2mg/kg) or nitrofurantoin (dose 2 mg/kg) as determined by clinician.~Antibiotic Prophylaxis"
11224084|NCT02357758|OG001|Outcome|Healthy Population|Patients with no history of RUTI or recent antibiotic usage.
10878044|NCT00450424|FG001|Participant Flow|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor.
10878045|NCT00450424|OG000|Outcome|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
10878046|NCT00450424|OG001|Outcome|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
10878047|NCT00450424|EG000|Reported Event|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
10878048|NCT00450424|EG001|Reported Event|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
10878049|NCT00450437|BG000|Baseline|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.
10878050|NCT00450437|BG001|Baseline|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
10878051|NCT00450437|BG002|Baseline|Total|Total of all reporting groups
10878052|NCT00450437|FG000|Participant Flow|Novartis MenACWY Vaccine (11 to 18 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
10878053|NCT00450437|FG001|Participant Flow|Licensed Meningococcal Vaccine (11 to 18 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
11002167|NCT01064362|FG001|Participant Flow|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
11002168|NCT01064362|OG000|Outcome|Fondaparinux|All dosages of fondaparinux
10878054|NCT00450437|FG002|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
10878055|NCT00450437|FG003|Participant Flow|Licensed Meningococcal Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
10878056|NCT00450437|OG000|Outcome|Novartis MenACWY Lot 1|One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
10878057|NCT00450437|OG001|Outcome|Novartis MenACWY Lot 2|One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
10878058|NCT00450437|OG002|Outcome|Novartis MenACWY Lot 3|One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
10878059|NCT00450437|OG000|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
10878060|NCT00450437|OG001|Outcome|Licensed Meninogcoccal Vaccine|One vaccination of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
10878061|NCT00450437|OG000|Outcome|Novartis MenACWY Vaccine|One dose of the meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
10878062|NCT00450437|OG001|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
10878063|NCT00450437|OG000|Outcome|Novartis MenACWY Lot 1|One dose of the meningococcal ACWY Lot 1 conjugate vaccine was administered intramuscularly.
10878064|NCT00450437|OG001|Outcome|Novartis MenACWY Lot 2|One dose of the meningococcal ACWY Lot 2 conjugate vaccine was administered intramuscularly.
10878065|NCT00450437|OG002|Outcome|Novartis MenACWY Lot 3|One dose of the meningococcal ACWY Lot 3 conjugate vaccine was administered intramuscularly.
11002169|NCT01064362|OG001|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
11002170|NCT01064362|EG000|Reported Event|Fondaparinux|All dosages of fondaparinux
11002171|NCT01064362|EG001|Reported Event|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
11002172|NCT01064401|BG000|Baseline|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
11002173|NCT01064401|BG001|Baseline|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
11002174|NCT01064401|BG002|Baseline|Total|Total of all reporting groups
11002175|NCT01064401|FG000|Participant Flow|Interferon Beta-1a|Interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly plus placebo to daclizumab high yield process (DAC HYP) subcutaneous (SC) once every 4 weeks for 96 to 144 weeks
11002176|NCT01064401|FG001|Participant Flow|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a intramuscular IM injection once weekly for 96 to 144 weeks
11002177|NCT01064401|OG000|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
11002178|NCT01064401|OG001|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
11002179|NCT01064401|OG001|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
11002180|NCT01064401|EG000|Reported Event|IFN Beta-1a 30 mcg|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
11002181|NCT01064401|EG001|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
11002182|NCT01064414|BG000|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks.
11002183|NCT01064414|BG001|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks.
11002184|NCT01064414|BG002|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.
11002185|NCT01064414|BG003|Baseline|Total|Total of all reporting groups
11002186|NCT01064414|FG000|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
11002187|NCT01064414|FG001|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
11002188|NCT01064414|FG002|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
11002189|NCT01064414|OG000|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
11002190|NCT01064414|OG001|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
11002191|NCT01064414|OG002|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
11002192|NCT01064414|EG000|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26.
11002193|NCT01064414|EG001|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
11002194|NCT01064414|EG002|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
11002195|NCT01064414|EG003|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 52.
11002196|NCT01064414|EG004|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
11002197|NCT01064414|EG005|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
11002198|NCT01064531|BG000|Baseline|MIS Femoral Neck Stem|Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
11002199|NCT01064531|BG001|Baseline|Synergy Hip System|Standard total hip arthroplasty (THA) using total hip system.
11002200|NCT01064531|BG002|Baseline|Total|Total of all reporting groups
11002201|NCT01064531|FG000|Participant Flow|MIS Femoral Neck Stem|Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
11002202|NCT01064531|FG001|Participant Flow|Synergy Hip System|Standard total hip arthroplasty (THA) using total hip system.
11002203|NCT01064531|OG000|Outcome|MIS Femoral Neck Stem|Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
11002204|NCT01064531|OG001|Outcome|Synergy Hip System|Standard total hip arthroplasty (THA) using total hip system.
11002205|NCT01064531|EG000|Reported Event|MIS Femoral Neck Stem|Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
11002206|NCT01064531|EG001|Reported Event|Synergy Hip System|Standard total hip arthroplasty (THA) using total hip system.
11002207|NCT01064622|BG000|Baseline|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
11002208|NCT01064622|BG001|Baseline|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
11002209|NCT01064622|BG002|Baseline|Phase I lead-in Patients|Patients enrolled in the lead-in phase I portion of the trial. Patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and 150 mg vismodegib PO QD on days 1-28.
11002210|NCT01064622|BG003|Baseline|Total|Total of all reporting groups
11002211|NCT01064622|FG000|Participant Flow|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
11002212|NCT01064622|FG001|Participant Flow|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
11002213|NCT01064622|OG000|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
11002214|NCT01064622|OG001|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
11002215|NCT01064622|OG002|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
11002216|NCT01064622|EG000|Reported Event|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
11002217|NCT01064622|EG001|Reported Event|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
11002218|NCT01064622|EG002|Reported Event|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
11002219|NCT01064622|EG003|Reported Event|Phase II Crossover Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
11002220|NCT01064687|BG000|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002221|NCT01064687|BG001|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002222|NCT01064687|BG002|Baseline|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002223|NCT01064687|BG003|Baseline|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
11002224|NCT01064687|BG004|Baseline|Total|Total of all reporting groups
11002225|NCT01064687|FG000|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002226|NCT01064687|FG001|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002227|NCT01064687|FG002|Participant Flow|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002228|NCT01064687|FG003|Participant Flow|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
11002229|NCT01064687|OG000|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002230|NCT01064687|OG001|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002231|NCT01064687|OG002|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002232|NCT01064687|OG003|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
11002233|NCT01064687|OG003|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
10878066|NCT00450437|EG000|Reported Event|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age.
10878067|NCT00450437|EG001|Reported Event|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age.
10878068|NCT00450463|BG000|Baseline|Flutamide Alone|"Patients receive flutamide orally 3 times a day on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising prostatic specific antigen (PSA) levels) without metastatic disease (as evidenced on scans), may receive vaccine treatment as defined in arm II beginning 4 weeks after flutamide therapy is discontinued.~Flutamide (Eulexin): Orally administered, nonsteroidal, competitive antagonist of testosterone and other androgens at androgenic receptors and may alter the nuclear translocation of the androgen/receptor complex."
10878069|NCT00450463|BG001|Baseline|Flutamide + Vaccine + Sargramostim|"Patients receive flutamide orally 3 times a day on days 1-28. Patients also receive recombinant vaccinia PSA vaccine subcutaneously (SC) on day 1 of course 1 only and recombinant fowlpox PSA vaccine SC on day 1 of all subsequent courses. Patients receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.~Sargramostim (GM-CSF, Leukine): A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant DNA technology in yeast Saccharomyces cerevisiae). Sargramostim is a 127 amino acid glycoprotein, altered from the native, natural human GM-CSF molecule; the position 23 arginine has been replaced with a leucine to facilitate the expression of the protein in yeast"
10878070|NCT00450463|BG002|Baseline|Total|Total of all reporting groups
10878071|NCT00450463|FG000|Participant Flow|Flutamide Alone|"Patients receive flutamide orally 3 times a day on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising prostatic specific antigen (PSA) levels) without metastatic disease (as evidenced on scans), may receive vaccine treatment as defined in arm II beginning 4 weeks after flutamide therapy is discontinued.~Flutamide (Eulexin): Orally administered, nonsteroidal, competitive antagonist of testosterone and other androgens at androgenic receptors and may alter the nuclear translocation of the androgen/receptor complex."
10878072|NCT00450463|FG001|Participant Flow|Flutamide + Vaccine + Sargramostim|"Patients receive flutamide orally 3 times a day on days 1-28. Patients also receive recombinant vaccinia PSA vaccine subcutaneously (SC) on day 1 of course 1 only and recombinant fowlpox PSA vaccine SC on day 1 of all subsequent courses. Patients receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.~Sargramostim (GM-CSF, Leukine): A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant DNA technology in yeast Saccharomyces cerevisiae). Sargramostim is a 127 amino acid glycoprotein, altered from the native, natural human GM-CSF molecule; the position 23 arginine has been replaced with a leucine to facilitate the expression of the protein in yeast"
10878073|NCT00450463|OG000|Outcome|Flutamide Alone|"Patients receive flutamide orally 3 times a day on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising prostatic specific antigen (PSA) levels) without metastatic disease (as evidenced on scans), may receive vaccine treatment as defined in arm II beginning 4 weeks after flutamide therapy is discontinued.~Flutamide (Eulexin): Orally administered, nonsteroidal, competitive antagonist of testosterone and other androgens at androgenic receptors and may alter the nuclear translocation of the androgen/receptor complex."
10878074|NCT00450463|OG001|Outcome|Flutamide + Vaccine + Sargramostim|"Patients receive flutamide orally 3 times a day on days 1-28. Patients also receive recombinant vaccinia PSA vaccine subcutaneously (SC) on day 1 of course 1 only and recombinant fowlpox PSA vaccine SC on day 1 of all subsequent courses. Patients receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.~Sargramostim (GM-CSF, Leukine): A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant deoxyribonucleic acid (DNA) technology in yeast Saccharomyces cerevisiae)."
10878075|NCT00450463|OG002|Outcome|Vaccine Alone After Flutamide|May receive vaccine treatment after flutamide is discontinued.
10878076|NCT00450463|OG001|Outcome|Flutamide + Vaccine + Sargramostim|Patients receive flutamide orally 3 times a day on days 1-28. Patients also receive recombinant vaccinia PSA vaccine subcutaneously (SC) on day 1 of course 1 only and recombinant fowlpox PSA vaccine SC on day 1 of all subsequent courses. Patients receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.S argramostim (GM-CSF, Leukine): A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant deoxyribonucleic acid (DNA) technology in yeast Saccharomyces cerevisiae). Sargramostim is a 127 amino acid glycoprotein, altered from the native, natural human GM-CSF molecule; the position 23 arginine has been replaced with a leucine to facilitate the expression
10879505|NCT00458237|OG000|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
11007752|NCT01092728|BG000|Baseline|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
11007753|NCT01092728|BG001|Baseline|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
10845756|NCT00269477|EG002|Reported Event|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
10845757|NCT00269477|EG003|Reported Event|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
10845758|NCT00269633|BG000|Baseline|Red Light Box|"657 nm~Red Light Box: 657 nm Red LED Light"
10845759|NCT00269633|BG001|Baseline|Blue Light Box|"467 nm~Blue Light Box: 467 nm Blue LED Light"
10845760|NCT00269633|BG002|Baseline|Total|Total of all reporting groups
10845761|NCT00269633|FG000|Participant Flow|Red Light Box 657 nm|LED Red Light Box 657 nm
10845762|NCT00269633|FG001|Participant Flow|Blue Light Box 467 nm|LED Blue Light Box 467 nm
10845763|NCT00269633|OG000|Outcome|Red Light Box 657 nm|LED Red Light Box 657 nm
10845764|NCT00269633|OG001|Outcome|Blue Light Box 467 nm|LED Blue Light Box 467 nm
10845765|NCT00269633|EG000|Reported Event|Red Light Box|Red Light Box: 657 nm Blue LED Light
10845766|NCT00269633|EG001|Reported Event|Blue Light Box|"467 nm~Blue Light Box: 467 nm Blue LED Light"
10845767|NCT00269919|BG000|Baseline|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
10845768|NCT00269919|FG000|Participant Flow|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 2 years.
10845769|NCT00269919|OG000|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
10845770|NCT00269919|OG000|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg had been administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
10845771|NCT00269919|EG000|Reported Event|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
10845772|NCT00270205|BG000|Baseline|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
10845773|NCT00270205|BG001|Baseline|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
10845774|NCT00270205|BG002|Baseline|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
10845775|NCT00270205|BG003|Baseline|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
10845776|NCT00270205|BG004|Baseline|Total|Total of all reporting groups
10845777|NCT00270205|FG000|Participant Flow|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
10845778|NCT00270205|FG001|Participant Flow|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
10845779|NCT00270205|FG002|Participant Flow|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
10845780|NCT00270205|FG003|Participant Flow|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
10845781|NCT00270205|OG000|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
10845782|NCT00270205|OG001|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
10845783|NCT00270205|OG002|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
10845784|NCT00270205|OG003|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
10845785|NCT00270205|EG000|Reported Event|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
10846631|NCT00278629|OG000|Outcome|Hematopoietic Stem Cell Transplantation for CIDP|Autologous hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide 200 mg/kg/intravenously(IV), rATG(thymoglobulin) 5.5 mg/kg/IV and rituximab 1000mg/IV.
10846632|NCT00278629|EG000|Reported Event|Hematopoietic Stem Cell Transplantation for CIDP|Autologous hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide 200 mg/kg/intravenously(IV), rATG(thymoglobulin) 5.5 mg/kg/IV and rituximab 1000mg/IV.
10846633|NCT00278655|BG000|Baseline|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.~hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
10846634|NCT00278655|FG000|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and granulocyte colony-stimulating factor (G-CSF) (5-10mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
10846635|NCT00278655|OG000|Outcome|Stem Cell Transplantation|Autologous hematopoietic stem cell transplantation Peripheral blood stem cells were mobilised with 2g per square m intravenous (IV) cyclophosphamide (CY) followed by 10 µg per kg subcutaneous filgrastim daily from day 5. After neutrophil recovery, the mobilised cells were collected by apheresis. The recovered cells were unselected and cryopreserved. There was at least three weeks between mobilisation and the conditioning regimen. The conditioning regimen used was 200 mg per kg intravenous CY , given in four equal fractions between day -5 and day -2 with IV mesna, and one 20mg dose of IV alemtuzumab (CAMPATH-1H) given on day -2 with 250 mg intravenous methyl-prednisolone as premedication. Alemtuzumab was changed to rabbit antithymocyte globulin rATG) in the last 4 patients, who received 6 mg per kg rATG over 5 days instead of alemtuzumab . Stem cells wer reinfused 36 h after completion of CY. 5 µg/kg/day filgrastim was given from day 5 until neutrophil recovery.
10846636|NCT00278655|OG000|Outcome|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and G-CSF (5-10 mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
10846637|NCT00278655|EG000|Reported Event|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.~hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
10846638|NCT00278863|BG000|Baseline|S-1 for 2 Weeks on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
10846639|NCT00278863|BG001|Baseline|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
10846640|NCT00278863|BG002|Baseline|Total|Total of all reporting groups
10846641|NCT00278863|FG000|Participant Flow|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
10846642|NCT00278863|FG001|Participant Flow|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
10846643|NCT00278863|OG000|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
10846644|NCT00278863|OG001|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
10846645|NCT00278863|EG000|Reported Event|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
10846646|NCT00278863|EG001|Reported Event|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
10846647|NCT00278876|BG000|Baseline|Imatinib Mesylate|patients receiving adjuvant imatinib mesylate
10846648|NCT00278876|FG000|Participant Flow|Imatinib Mesylate|imatinib mesylate 400 mg daily for 2 years
10846649|NCT00278876|OG000|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
10846650|NCT00278876|EG000|Reported Event|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
10846651|NCT00278889|BG000|Baseline|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
10846652|NCT00278889|BG001|Baseline|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
10846653|NCT00278889|BG002|Baseline|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
10846654|NCT00278889|BG003|Baseline|Total|Total of all reporting groups
10846655|NCT00278889|FG000|Participant Flow|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
10846656|NCT00278889|FG001|Participant Flow|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
10846657|NCT00278889|FG002|Participant Flow|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
10846658|NCT00278889|OG000|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
10846659|NCT00278889|OG001|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
10846660|NCT00278889|OG002|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
10846661|NCT00278889|EG000|Reported Event|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
10846662|NCT00278889|EG001|Reported Event|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
10846663|NCT00278889|EG002|Reported Event|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
11002234|NCT01064687|OG004|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002235|NCT01064687|OG000|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002236|NCT01064687|OG001|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002237|NCT01064687|OG002|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
11002238|NCT01064687|OG002|Outcome|Placebo/0.75 mg LY2189265 or 1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002239|NCT01064687|EG000|Reported Event|0.75 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002240|NCT01064687|EG001|Reported Event|1.5 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002241|NCT01064687|EG002|Reported Event|Exenatide (Baseline Through 26 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002242|NCT01064687|EG003|Reported Event|Placebo (Baseline Through 26 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52)~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002243|NCT01064687|EG004|Reported Event|0.75 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002244|NCT01064687|EG005|Reported Event|1.5 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002245|NCT01064687|EG006|Reported Event|Exenatide (Baseline Through 56 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
11002246|NCT01064687|EG007|Reported Event|Placebo/0.75 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks~All events were treatment emergent during the LY2189265 treatment period."
11002247|NCT01064687|EG008|Reported Event|Placebo/1.5 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks~All events were treatment emergent during the LY2189265 treatment period."
11002248|NCT01064713|BG000|Baseline|40 mg Tesetaxel, Cohort A|Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
11002249|NCT01064713|BG001|Baseline|50 mg Tesetaxel, Cohort B|Therapy initiated at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
11002250|NCT01064713|BG002|Baseline|Total|Total of all reporting groups
11002251|NCT01064713|FG000|Participant Flow|40 mg Tesetaxel, Cohort A|Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
11002252|NCT01064713|FG001|Participant Flow|50 mg Tesetaxel, Cohort B|Therapy initiated at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
11002253|NCT01064713|OG000|Outcome|40 mg Tesetaxel, Cohort A|Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
11002254|NCT01064713|OG001|Outcome|50 mg Tesetaxel, Cohort B|Therapy initiated at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
11002255|NCT01064713|EG000|Reported Event|40 Tesetaxel, Cohort A|Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
11007754|NCT01092728|BG002|Baseline|Total|Total of all reporting groups
11224085|NCT02357758|OG002|Outcome|Clinical Observation|Patients experiencing RUTI that do not require antibiotic prophylaxis as determined by clinician.
10845786|NCT00270205|EG001|Reported Event|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
10845787|NCT00270205|EG002|Reported Event|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
10845788|NCT00270205|EG003|Reported Event|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
10878077|NCT00450463|EG000|Reported Event|Flutamide Alone|"Patients receive flutamide orally 3 times a day on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising prostatic specific antigen (PSA) levels) without metastatic disease (as evidenced on scans), as defined in arm II beginning 4 weeks after flutamide therapy is discontinued.~Flutamide (Eulexin): Orally administered, nonsteroidal, competitive antagonist of testosterone and other androgens at androgenic receptors and may alter the nuclear translocation of the androgen/receptor complex."
10878078|NCT00450463|EG001|Reported Event|Flutamide + Vaccine + Sargramostim|"Patients receive flutamide orally 3 times a day on days 1-28. Patients also receive recombinant vaccinia PSA vaccine subcutaneously (SC) on day 1 of course 1 only and recombinant fowlpox PSA vaccine SC on day 1 of all subsequent courses. Patients receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.~Sargramostim (GM-CSF, Leukine): A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant DNA technology in yeast Saccharomyces cerevisiae). Sargramostim is a 127 amino acid glycoprotein, altered from the native, natural human GM-CSF molecule; the position 23 arginine has been replaced with a leucine to facilitate the expression of the protein in yeast"
10878079|NCT00450463|EG002|Reported Event|Vaccine Alone After Flutamide|May receive vaccine treatment after flutamide is discontinued.
10878080|NCT00450580|BG000|Baseline|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
10878081|NCT00450580|BG001|Baseline|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
10878082|NCT00450580|BG002|Baseline|Total|Total of all reporting groups
10878083|NCT00450580|FG000|Participant Flow|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
10878084|NCT00450580|FG001|Participant Flow|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
10878085|NCT00450580|OG000|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
10878086|NCT00450580|OG001|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
10878087|NCT00450580|EG000|Reported Event|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
10878088|NCT00450580|EG001|Reported Event|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
10878089|NCT00450619|BG000|Baseline|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
10878090|NCT00450619|BG001|Baseline|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
10878091|NCT00450619|BG002|Baseline|Total|Total of all reporting groups
10878092|NCT00450619|FG000|Participant Flow|Arm A- EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
10878093|NCT00450619|FG001|Participant Flow|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
10878094|NCT00450619|OG000|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
10878095|NCT00450619|OG001|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
10878096|NCT00450619|OG000|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
10878097|NCT00450619|EG000|Reported Event|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
11002256|NCT01064713|EG001|Reported Event|50 mg Tesetaxel, Cohort B|Therapy initiated at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
11224086|NCT02357758|EG000|Reported Event|Antibiotic Prophylaxis|"Patients with RUTI receiving Septra (Trimethoprim dose 2mg/kg) or nitrofurantoin (dose 2 mg/kg) as determined by clinician.~Antibiotic Prophylaxis"
11224087|NCT02357758|EG001|Reported Event|Healthy Population|Patients with no history of RUTI or recent antibiotic usage.
11224088|NCT02357758|EG002|Reported Event|Clinical Observation|Patients experiencing RUTI that do not require antibiotic prophylaxis as determined by clinician.
11224089|NCT02357836|BG000|Baseline|Itraconazole|"600 mg twice daily for 10-14 days~Itraconazole: Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, Post-treatment assessments will include a skin biopsy, blood draw for the PK analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure."
11224090|NCT02357836|FG000|Participant Flow|Itraconazole|"600 mg twice daily for 10-14 days~Itraconazole: Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, Post-treatment assessments will include a skin biopsy, blood draw for the PK analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure."
10878098|NCT00450619|EG001|Reported Event|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
10878099|NCT00450658|BG000|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
10878100|NCT00450658|BG001|Baseline|Ibuprofen|Ibuprofen 800mg
10878101|NCT00450658|BG002|Baseline|Total|Total of all reporting groups
10878102|NCT00450658|FG000|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg tablets t.i.d.
10878103|NCT00450658|FG001|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
10878104|NCT00450658|OG000|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
10878105|NCT00450658|OG001|Outcome|Ibuprofen|Ibuprofen 800mg
10878106|NCT00450658|EG000|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
10878107|NCT00450658|EG001|Reported Event|Ibuprofen|Ibuprofen 800mg
10878108|NCT00450723|BG000|Baseline|Single Arm|
10878109|NCT00450723|FG000|Participant Flow|Sentinel Lymph Node Biopsy|
10878110|NCT00450723|OG000|Outcome|Sentinel Lymph Node Biopsy|
10878111|NCT00450723|OG000|Outcome|Sentinel Lymph Node BIopsy|
10878112|NCT00450723|EG000|Reported Event|Single Arm|
10878113|NCT00450749|BG000|Baseline|Arm I Placebo|Placebo once daily for 4-7 weeks.
10878114|NCT00450749|BG001|Baseline|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
10878115|NCT00450749|BG002|Baseline|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
10878116|NCT00450749|BG003|Baseline|Total|Total of all reporting groups
10878117|NCT00450749|FG000|Participant Flow|Arm I Placebo|Placebo once daily for 4-7 weeks.
10878118|NCT00450749|FG001|Participant Flow|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
10878119|NCT00450749|FG002|Participant Flow|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
10878120|NCT00450749|OG000|Outcome|Arm I Placebo|Placebo once daily for 4-7 weeks.
10878121|NCT00450749|OG001|Outcome|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
10878122|NCT00450749|OG002|Outcome|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
10878123|NCT00450749|EG000|Reported Event|Arm I Placebo|Placebo once daily for 4-7 weeks.
10878124|NCT00450749|EG001|Reported Event|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
10878125|NCT00450749|EG002|Reported Event|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
10878126|NCT00450801|BG000|Baseline|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
10878127|NCT00450801|FG000|Participant Flow|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
10878128|NCT00450801|OG000|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
10878129|NCT00450801|OG000|Outcome|R-MACLO Cycles|Number of patients experiencing adverse events during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
10878130|NCT00450801|OG001|Outcome|R-IVAM Cycles|Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
10878131|NCT00450801|OG002|Outcome|Thalidomide Therapy|Number of patients experiencing adverse events during Thalidomide maintenance therapy.
10878132|NCT00450801|EG000|Reported Event|R-MACLO Cycles|Adverse Events occurring during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
10878133|NCT00450801|EG001|Reported Event|R-IVAM Cycles|Adverse Events occurring during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
11002257|NCT01064739|BG000|Baseline|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
11002258|NCT01064739|FG000|Participant Flow|Fixed Sodium Diet +/- Fava Beans|Participants consumed a fixed sodium diet on day 1 and the same diet plus 100g of fresh fava beans at breakfast and lunch on day 2.The 14 participants received both interventions.
11002259|NCT01064739|OG000|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
11002260|NCT01064739|OG001|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
11002261|NCT01064739|OG000|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
11002262|NCT01064739|OG001|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
11002263|NCT01064739|OG001|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
11002264|NCT01064739|OG001|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
11002265|NCT01064739|EG000|Reported Event|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
11002266|NCT01064739|EG001|Reported Event|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
11002267|NCT01064830|BG000|Baseline|Cyclosporine Solution|apply to affected nails at night
11002268|NCT01064830|BG001|Baseline|Vehicle|apply to affected nails at night
11224479|NCT02360319|FG000|Participant Flow|Clinician's Choice|"Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years~Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients"
11224480|NCT02360319|FG001|Participant Flow|Aripiprazole Once Monthly|"Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years~aripiprazole long acting injectable formulation"
11002269|NCT01064830|BG002|Baseline|Total|Total of all reporting groups
11002270|NCT01064830|FG000|Participant Flow|Cyclosporine Solution 0.05% (Restasis®)|Topical Cyclosporine 0.05% Ophthalmic Suspension
11002271|NCT01064830|FG001|Participant Flow|Vehicle (Refresh Dry Eye Therapy®)|Topical vehicle: Refresh Dry Eye Therapy® (ophthalmic solution of glycerin 1% and polysorbate 80 1%)
11002272|NCT01064830|OG000|Outcome|Cyclosporine Solution|topical
11002273|NCT01064830|OG001|Outcome|Vehicle|topical
11002274|NCT01064830|OG000|Outcome|Cyclosporine Solution|cyclosporine solution
11002275|NCT01064830|OG001|Outcome|Vehicle|vehicle
11002276|NCT01064830|EG000|Reported Event|Cyclosporine Solution|topical
11002277|NCT01064830|EG001|Reported Event|Vehicle|topical
11002278|NCT01064856|BG000|Baseline|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
11002279|NCT01064856|BG001|Baseline|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
11002280|NCT01064856|BG002|Baseline|Total|Total of all reporting groups
11002281|NCT01064856|FG000|Participant Flow|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
11002282|NCT01064856|FG001|Participant Flow|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
11002283|NCT01064856|FG002|Participant Flow|Double-blind Adalimumab / Open-label Adalimumab|Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
11002284|NCT01064856|FG003|Participant Flow|Double-blind Placebo / Open-label Adalimumab|Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
11002285|NCT01064856|OG000|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
11002286|NCT01064856|OG001|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
11002287|NCT01064856|EG000|Reported Event|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
11002288|NCT01064856|EG001|Reported Event|Double-blind Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
11002289|NCT01064856|EG002|Reported Event|Any Adalimumab|All randomized participants who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).
11002290|NCT01064882|BG000|Baseline|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
11002291|NCT01064882|BG001|Baseline|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
11002292|NCT01064882|BG002|Baseline|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
11002293|NCT01064882|BG003|Baseline|Total|Total of all reporting groups
11002294|NCT01064882|FG000|Participant Flow|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
11002295|NCT01064882|FG001|Participant Flow|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
11002296|NCT01064882|FG002|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
11002297|NCT01064882|OG000|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
11002298|NCT01064882|OG001|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
11002299|NCT01064882|OG002|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
11002300|NCT01064882|EG000|Reported Event|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
11002301|NCT01064882|EG001|Reported Event|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
11002302|NCT01064882|EG002|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
11002303|NCT01064947|BG000|Baseline|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
11002304|NCT01064947|FG000|Participant Flow|All Participants|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
11002305|NCT01064947|OG000|Outcome|All Participants at Day 1|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if necessary) for 7 days. The subject treatment site was cultured after 7 days of treatment.
11002306|NCT01064947|OG001|Outcome|Participants With a Positive Culture at Day 1|
11002307|NCT01064947|OG000|Outcome|Participants With Positive Culture at Day 1|
11002308|NCT01064947|OG000|Outcome|Participants With a Positive Culture at Day 1|
11002309|NCT01064947|OG000|Outcome|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
11002310|NCT01064947|EG000|Reported Event|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
11002311|NCT01065350|BG000|Baseline|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
11002312|NCT01065350|BG001|Baseline|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. One subject in the ketofol group was excluded from analysis due to incorrect study drug assignment and outside the protocol-specified dose."
11002313|NCT01065350|BG002|Baseline|Total|Total of all reporting groups
11002314|NCT01065350|FG000|Participant Flow|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
11002315|NCT01065350|FG001|Participant Flow|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
11002316|NCT01065350|OG000|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
11002317|NCT01065350|OG001|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
11002318|NCT01065350|EG000|Reported Event|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
11002319|NCT01065350|EG001|Reported Event|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
11002320|NCT01065428|BG000|Baseline|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
11002321|NCT01065428|BG001|Baseline|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
11002322|NCT01065428|BG002|Baseline|Total|Total of all reporting groups
11002323|NCT01065428|FG000|Participant Flow|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
11002324|NCT01065428|FG001|Participant Flow|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
11002325|NCT01065428|OG000|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
11002326|NCT01065428|OG001|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
11002327|NCT01065428|EG000|Reported Event|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
11002328|NCT01065428|EG001|Reported Event|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
11002329|NCT01065480|BG000|Baseline|Live Teleconference Supervision|Clinicians from participating substance abuse treatment programs receive live supervision by MI trainer via teleconference while in session with client.
11002330|NCT01065480|BG001|Baseline|Taped Review Supervision|Clinicians from participating substance treatment programs audio record session with client and receive supervision after the session by MI trainer.
11002331|NCT01065480|BG002|Baseline|Total|Total of all reporting groups
11002332|NCT01065480|FG000|Participant Flow|Live Teleconference Supervision|Clinicians from participating substance abuse treatment programs receive live supervision by MI trainer via teleconference while in session with client.
11002333|NCT01065480|FG001|Participant Flow|Taped Review Supervision|Clinicians from participating substance treatment programs audio record session with client and receive supervision after the session by MI trainer.
11002334|NCT01065480|OG000|Outcome|Live Teleconference Supervision|Clinicians from participating substance abuse treatment programs receive live supervision by MI trainer via teleconference while in session with client.
11002335|NCT01065480|OG001|Outcome|Taped Review Supervision|Clinicians from participating substance treatment programs audio record session with client and receive supervision after the session by MI trainer.
11336502|NCT03567252|EG000|Reported Event|Walking Group|"Participants in this group will join an established walking group and travel by foot 1 kilometer to a local Farmer's Market. They will also receive handouts about nutrition information and nutritional choices.~Walking Group: Participants will walk 1 kilometer to a Farmer's Market."
10845789|NCT00270231|BG000|Baseline|Entire Study Population|Includes subjects with both OPRM1 genotypes (Asp40 (A/G or G/G allele vs. Asn40 (A/A) allele) who started Intervention Period 1.
11002336|NCT01065480|EG000|Reported Event|Live Teleconference Supervision|Clinicians from participating substance abuse treatment programs receive live supervision by MI trainer via teleconference while in session with client.
11002337|NCT01065480|EG001|Reported Event|Taped Review Supervision|Clinicians from participating substance treatment programs audio record session with client and receive supervision after the session by MI trainer.
11002338|NCT01065506|BG000|Baseline|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
11002339|NCT01065506|BG001|Baseline|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
11002340|NCT01065506|BG002|Baseline|Total|Total of all reporting groups
11002341|NCT01065506|FG000|Participant Flow|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program consisting of thrice weekly sessions involving discussion of various wellness topics (e.g., diet, sun care, cancer prevention) and generating small wellness-related goals"
11002342|NCT01065506|FG001|Participant Flow|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise thrice weekly (on a treadmill)"
11002343|NCT01065506|OG000|Outcome|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
11002344|NCT01065506|OG001|Outcome|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
11002345|NCT01065506|EG000|Reported Event|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
11002346|NCT01065506|EG001|Reported Event|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
11002347|NCT01065558|BG000|Baseline|Ecopipam|
11002348|NCT01065558|FG000|Participant Flow|Ecopipam (12.5- 200 mg/Day)|"Patients were given ecopipapm over an 11 day period as follows:~day 1 12.5 mg/day day 2-3 25 mg/day day 4-5 50 mg/day day 6-9 100 mg/day day 9-11 200 mg/day~Note: Doses were reduced as necessary to a previously tolerated dose if paitents reached doses that were not safely tolerable."
11002349|NCT01065558|OG000|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
11002350|NCT01065558|EG000|Reported Event|Ecopipam Treated Patients|
11002351|NCT01065571|BG000|Baseline|Carrageenan-free Diet With Placebo|"This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis.~dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet."
11007755|NCT01092728|FG000|Participant Flow|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
11002352|NCT01065571|BG001|Baseline|Carrageenan-free Diet w/ Carrageenan|"The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption.~carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet."
11002353|NCT01065571|BG002|Baseline|Total|Total of all reporting groups
11002354|NCT01065571|FG000|Participant Flow|Carrageenan-free Diet With Placebo|"This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis.~dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet."
11002355|NCT01065571|FG001|Participant Flow|Carrageenan-free Diet w/ Carrageenan|"The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption.~carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet."
11002356|NCT01065571|OG000|Outcome|Carrageenan-free Diet With Placebo|"This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis.~dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet."
11002357|NCT01065571|OG001|Outcome|Carrageenan-free Diet w/ Carrageenan|"The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption.~carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet."
11002358|NCT01065571|OG000|Outcome|no Carrageenan Group|carrageenan-free diet with placebo group
11002359|NCT01065571|OG001|Outcome|Carrageenan Exposed|carrageenan-free diet with added carrageenan group
11002360|NCT01065571|EG000|Reported Event|Carrageenan-free Diet w/ Carrageenan|"The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption.~carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet."
11002361|NCT01065571|EG001|Reported Event|Carrageenan-free Diet With Placebo|"This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis.~dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet."
11002362|NCT01065597|BG000|Baseline|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
11002363|NCT01065597|FG000|Participant Flow|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
10845790|NCT00270231|FG000|Participant Flow|Naltrexone, Then Placebo|"These participants took active naltrexone during their first 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg.~They received placebo (sugar pill) during the second 4-day study period."
11002364|NCT01065597|OG000|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
11002365|NCT01065597|EG000|Reported Event|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
11002366|NCT01065714|BG000|Baseline|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
11002367|NCT01065714|FG000|Participant Flow|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment. Eucerin Lotion applied to one side of body, Hydrogel applied to the opposite side of body.
11002368|NCT01065714|OG000|Outcome|Skin Barrier Function With Eucerin Lotion|Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
11002369|NCT01065714|OG000|Outcome|Skin Barrier Function With Hydrogel Vehicle|Trans epidural water loss measurements on target areas of body side treated with Hydrogel vehicle
11002370|NCT01065714|OG000|Outcome|Skin Hydration With Eucerin|Parallel designed study. Split body treatment. Five corneometer readings were taken on the targeted area of one half of the body on which Eucerin Lotion was applied.
11002371|NCT01065714|OG000|Outcome|Skin Hydration With Hydrogel|Parallel designed study. Split body treatment. Hydrogel vehicle applied to targeted area one side of body. Skin Hydration measured by 5 Corneometer readings.
11002372|NCT01065714|EG000|Reported Event|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
11002373|NCT01065766|BG000|Baseline|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
11002374|NCT01065766|FG000|Participant Flow|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
11002375|NCT01065766|OG000|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
11002376|NCT01065766|EG000|Reported Event|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
11002377|NCT01065844|BG000|Baseline|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
11002378|NCT01065844|FG000|Participant Flow|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
11002379|NCT01065844|OG000|Outcome|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
11002380|NCT01065844|EG000|Reported Event|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
11002381|NCT01066000|BG000|Baseline|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
11002382|NCT01066000|FG000|Participant Flow|Mircera|Eligible participants received methoxy polyethylene glycol-epoetin beta (Mircera) intravenously (IV), once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 microgram (mcg) which was based on the Epoetin dose of<8000, 8000-16000, or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
11002383|NCT01066000|OG000|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
11002384|NCT01066000|EG000|Reported Event|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
11002385|NCT01066026|BG000|Baseline|Metallic Cannula and Standart Cannula|Nasolabial Folds received fullers with Metallic Cannula or with Standard Needle
11002386|NCT01066026|FG000|Participant Flow|Metallic Cannula|Standard needle and metallic cannula were used in the same patient, with split face.
11002387|NCT01066026|OG000|Outcome|Metallic Cannula|Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
11002388|NCT01066026|OG001|Outcome|Standard Needle|Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
11224091|NCT02357836|OG000|Outcome|Itraconazole|"600 mg twice daily for 10-14 days~Itraconazole: Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, Post-treatment assessments will include a skin biopsy, blood draw for the PK analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure."
11002389|NCT01066026|EG000|Reported Event|Metallic Cannula|Nasolabial Fold with Metallic Cannula
11002390|NCT01066026|EG001|Reported Event|Standard Needle|Nasolabial Fold with standard needle
11002391|NCT01066039|BG000|Baseline|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
11002392|NCT01066039|FG000|Participant Flow|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure was not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
11002393|NCT01066039|OG000|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
11002394|NCT01066039|EG000|Reported Event|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
11002395|NCT01066052|BG000|Baseline|r-hGH|Participants (girls) received r-hGH as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received depended on participants' baseline height SDS relative to the general population standard: participants with a height SDS of -2 SD or lower received 0.05 mg/kg per day r-hGH and those with a height SDS between -1 and -2 SD received 0.035 mg/kg per day r-hGH. After 2 years of treatment, all participants received a fixed dose of 0.05 mg/kg per day for a further 2 years.
11002396|NCT01066052|BG001|Baseline|Historical Control|This arm included matching (age and height) historical control participants (girls) with turner syndrome, who were born between 1961 and 1990 and were untreated.
11002397|NCT01066052|BG002|Baseline|Total|Total of all reporting groups
11002398|NCT01066052|FG000|Participant Flow|Recombinant Human Growth Hormone (r-hGH)|Participants (girls) received r-hGH (Saizen®) as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received depended on participants' baseline height standard deviation score (SDS) relative to the general population standard: participants with a height SDS of -2 standard deviation (SD) or lower received 0.05 milligrams per kilogram (mg/kg) per day r-hGH and those with a height SDS between -1 and -2 SD received 0.035 mg/kg per day r-hGH. After 2 years of treatment, all participants received a fixed dose of 0.05 mg/kg per day for a further 2 years.
11002399|NCT01066052|FG001|Participant Flow|Historical Control|This arm included matching (age and height) historical control participants (girls) with turner syndrome, who were born between 1961 and 1990 and were untreated.
11002400|NCT01066052|OG000|Outcome|r-hGH|Participants (girls) received r-hGH as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received depended on participants' baseline height SDS relative to the general population standard: participants with a height SDS of -2 SD or lower received 0.05 mg/kg per day r-hGH and those with a height SDS between -1 and -2 SD received 0.035 mg/kg per day r-hGH. After 2 years of treatment, all participants received a fixed dose of 0.05 mg/kg per day for a further 2 years.
11002401|NCT01066052|OG001|Outcome|Historical Control|This arm included matching (age and height) historical control participants (girls) with turner syndrome, who were born between 1961 and 1990 and were untreated.
11002402|NCT01066052|EG000|Reported Event|r-hGH|Participants (girls) received r-hGH as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received depended on participants' baseline height SDS relative to the general population standard: participants with a height SDS of -2 SD or lower received 0.05 mg/kg per day r-hGH and those with a height SDS between -1 and -2 SD received 0.035 mg/kg per day r-hGH. After 2 years of treatment, all participants received a fixed dose of 0.05 mg/kg per day for a further 2 years.
11002403|NCT01066104|BG000|Baseline|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
11002404|NCT01066104|BG001|Baseline|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
11002405|NCT01066104|BG002|Baseline|Total|Total of all reporting groups
11002406|NCT01066104|FG000|Participant Flow|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
11002407|NCT01066104|FG001|Participant Flow|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
11002408|NCT01066104|OG000|Outcome|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
11002409|NCT01066104|OG001|Outcome|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
11002410|NCT01066104|EG000|Reported Event|Xolair Placebo|Xolair placebo: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
11002411|NCT01066104|EG001|Reported Event|Xolair (Omalizumab)|Xolair (omalizumab): two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
11002412|NCT01066143|BG000|Baseline|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
11002413|NCT01066143|FG000|Participant Flow|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
11002414|NCT01066143|OG000|Outcome|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
11002415|NCT01066143|EG000|Reported Event|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
11002416|NCT01066156|BG000|Baseline|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
11002417|NCT01066156|FG000|Participant Flow|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
11002418|NCT01066156|OG000|Outcome|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
11002419|NCT01066156|EG000|Reported Event|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
11002420|NCT01066364|BG000|Baseline|Placebo (Sugar) Pill|"Six tablets per day (identical to colesevelam)~Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)"
11002421|NCT01066364|BG001|Baseline|Colesevelam Arm|"3.75 grams per day~Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)"
11002422|NCT01066364|BG002|Baseline|Total|Total of all reporting groups
11002423|NCT01066364|FG000|Participant Flow|Placebo (Sugar) Pill|"Six tablets per day (identical to colesevelam)~Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)"
11002424|NCT01066364|FG001|Participant Flow|Colesevelam Arm|"3.75 grams per day~Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)"
11002425|NCT01066364|OG000|Outcome|Placebo (Sugar) Pill|"Six tablets per day (identical to colesevelam)~Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)"
11002426|NCT01066364|OG001|Outcome|Colesevelam Arm|"3.75 grams per day~Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)"
11002427|NCT01066364|EG000|Reported Event|Placebo (Sugar) Pill|"Six tablets per day (identical to colesevelam)~Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)"
11002428|NCT01066364|EG001|Reported Event|Colesevelam Arm|"3.75 grams per day~Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)"
11002429|NCT01066520|BG000|Baseline|Traumeel S Ointment|Traumeel S Ointment 2g, 3 times daily topical during 14 days
11002430|NCT01066520|BG001|Baseline|Traumeel S Gel|Traumeel S Gel 2g, 3 times daily topical during 14 days
11002431|NCT01066520|BG002|Baseline|Diclofenac Gel|Diclofenac Gel 2g, 3 times daily topical during 14 days
11002432|NCT01066520|BG003|Baseline|Total|Total of all reporting groups
11002433|NCT01066520|FG000|Participant Flow|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
11002434|NCT01066520|FG001|Participant Flow|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
11002435|NCT01066520|FG002|Participant Flow|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
11002436|NCT01066520|OG000|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
11224481|NCT02360319|OG000|Outcome|Clinician's Choice|"Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years~Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients"
10846664|NCT00278954|BG000|Baseline|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
10846665|NCT00278954|FG000|Participant Flow|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
11002437|NCT01066520|OG001|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
11002438|NCT01066520|OG002|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
11002439|NCT01066520|EG000|Reported Event|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
10846666|NCT00278954|OG000|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
10846667|NCT00278954|EG000|Reported Event|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
10846668|NCT00278993|BG000|Baseline|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
10846669|NCT00278993|FG000|Participant Flow|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
10846670|NCT00278993|OG000|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
10846671|NCT00278993|EG000|Reported Event|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
10846672|NCT00279201|BG000|Baseline|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
10846673|NCT00279201|BG001|Baseline|Lispro LM|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
10846674|NCT00279201|BG002|Baseline|Total|Total of all reporting groups
10846675|NCT00279201|FG000|Participant Flow|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
10846676|NCT00279201|FG001|Participant Flow|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
10846677|NCT00279201|FG002|Participant Flow|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
10846678|NCT00279201|FG003|Participant Flow|Lispro Low Mix Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
10846679|NCT00279201|FG004|Participant Flow|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
10846680|NCT00279201|FG005|Participant Flow|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
10846681|NCT00279201|OG000|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
10846682|NCT00279201|OG001|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
10846683|NCT00279201|OG000|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
10846684|NCT00279201|OG001|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
10846685|NCT00279201|OG000|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
10846686|NCT00279201|OG001|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
10846687|NCT00279201|OG002|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
10846688|NCT00279201|OG003|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
10846689|NCT00279201|OG000|Outcome|Insulin Gargine|Insulin glargine for 24 weeks.
10846690|NCT00279201|OG000|Outcome|Met Goal|
10846691|NCT00279201|OG001|Outcome|Did Not Meet Goal|
10846692|NCT00279201|OG000|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
10846693|NCT00279201|OG001|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
10846694|NCT00279201|OG000|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
11224482|NCT02360319|OG001|Outcome|Aripiprazole Once Monthly|"Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years~aripiprazole long acting injectable formulation"
10845791|NCT00270231|FG001|Participant Flow|Placebo, Then Naltrexone|"These participants took placebo (sugar pill) during their first 4-day study period.~They received active naltrexone during the second 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg."
10845792|NCT00270231|OG000|Outcome|OPRM1 Genotype - A/A|Participants who have the Asn40 OPRM1=A/A
10845793|NCT00270231|OG001|Outcome|OPRM1 Genotype - A/G or G/G|Participants who have the Asp40 OPRM1=A/G or G/G
11002440|NCT01066520|EG001|Reported Event|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
11002441|NCT01066520|EG002|Reported Event|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
10845794|NCT00270231|EG000|Reported Event|Naltrexone Only|Active medication recipients (Naltrexone taken for 4 days).
10845795|NCT00270231|EG001|Reported Event|Placebo Only|Placebo (sugar pill) recipients (taken for four days).
10845796|NCT00270257|BG000|Baseline|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
10845797|NCT00270257|BG001|Baseline|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
10845798|NCT00270257|BG002|Baseline|Total|Total of all reporting groups
10845799|NCT00270257|FG000|Participant Flow|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
10845800|NCT00270257|FG001|Participant Flow|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
10845801|NCT00270257|OG000|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
10845802|NCT00270257|OG001|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
10845803|NCT00270257|OG000|Outcome|China|Long Term and Short arms were compared
10845804|NCT00270257|OG001|Outcome|Thailand|Long Term and Short arms were compared
10845805|NCT00270257|EG000|Reported Event|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
10845806|NCT00270257|EG001|Reported Event|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
10845807|NCT00270296|BG000|Baseline|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
10845808|NCT00270296|BG001|Baseline|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
10845809|NCT00270296|BG002|Baseline|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
10845810|NCT00270296|BG003|Baseline|Total|Total of all reporting groups
10845811|NCT00270296|FG000|Participant Flow|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
10845812|NCT00270296|FG001|Participant Flow|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
10846695|NCT00279201|OG001|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
10846696|NCT00279201|OG000|Outcome|Insulin Glargine Participants Who Maintained Goal|
11002442|NCT01066546|BG000|Baseline|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
11002443|NCT01066546|FG000|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
11002444|NCT01066546|OG000|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
11002445|NCT01066546|EG000|Reported Event|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
11002446|NCT01066585|BG000|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
11002447|NCT01066585|BG001|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
11002448|NCT01066585|BG002|Baseline|Total|Total of all reporting groups
11002449|NCT01066585|FG000|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
10846697|NCT00279201|OG001|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
10846698|NCT00279201|OG000|Outcome|Lispro LM Participants Who Maintained Goal|
11002450|NCT01066585|FG001|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
10846699|NCT00279201|OG001|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
11002451|NCT01066585|OG000|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
11002452|NCT01066585|OG001|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
11002453|NCT01066585|EG000|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
11002454|NCT01066585|EG001|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
11002455|NCT01066624|BG000|Baseline|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
11002456|NCT01066624|BG001|Baseline|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
11002457|NCT01066624|BG002|Baseline|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
11002458|NCT01066624|BG003|Baseline|Total|Total of all reporting groups
11002459|NCT01066624|FG000|Participant Flow|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
11002460|NCT01066624|FG001|Participant Flow|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
11002461|NCT01066624|FG002|Participant Flow|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
11002462|NCT01066624|OG000|Outcome|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
11007756|NCT01092728|FG001|Participant Flow|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
11007757|NCT01092728|OG000|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
11224092|NCT02357836|OG000|Outcome|Itraconazole|"600 mg twice daily for 10-14 days~Itraconazole: Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, Post-treatment assessments will include a skin biopsy, blood draw for the PK (pharmacokinetics) analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure."
10878134|NCT00450801|EG002|Reported Event|Thalidomide Therapy|Adverse Events occurring during Thalidomide maintenance therapy.
10878135|NCT00450814|BG000|Baseline|Phase I: Stage 1 (MV-NIS Alone) Dose Level 1|Patients receive 1x10^6 MV-NIS (TCID50) IV over 1 hour on day 1.
10878136|NCT00450814|BG001|Baseline|Phase I: Stage 1 (MV-NIS Alone) Dose Level 2|Patients receive 1x10^7 MV-NIS (TCID50) IV over 1 hour on day 1.
10878137|NCT00450814|BG002|Baseline|Phase I: Stage 1 (MV-NIS Alone) Dose Level 3|Patients receive 1x10^8 MV-NIS (TCID50) IV over 1 hour on day 1.
10878138|NCT00450814|BG003|Baseline|Phase I: Stage 1 (MV-NIS Alone) Dose Level 4|Patients receive 1x10^9 MV-NIS (TCID50) IV over 1 hour on day 1.
10878139|NCT00450814|BG004|Baseline|Phase I: Stage 1 (MV-NIS Alone) Dose Level 5|Patients receive 1x10^10 MV-NIS (TCID50) IV over 1 hour on day 1.
10878140|NCT00450814|BG005|Baseline|Phase I: Stage 1 (MV-NIS Alone) Dose Level 6|Patients receive 1x10^11 MV-NIS (TCID50) IV over 1 hour on day 1.
10878141|NCT00450814|BG006|Baseline|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878142|NCT00450814|BG007|Baseline|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878143|NCT00450814|BG008|Baseline|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878144|NCT00450814|BG009|Baseline|Phase II (Acetaminophen + Benadryl + MV-NIS)|Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
10878145|NCT00450814|BG010|Baseline|Total|Total of all reporting groups
10878146|NCT00450814|FG000|Participant Flow|Phase I: Stage 1 (MV-NIS Alone) Dose Level 1|Patients receive 1x10^6 MV-NIS (TCID50) IV over 1 hour on day 1.
10878147|NCT00450814|FG001|Participant Flow|Phase I: Stage 1 (MV-NIS Alone) Dose Level 2|Patients receive 1x10^7 MV-NIS (TCID50) IV over 1 hour on day 1.
10878148|NCT00450814|FG002|Participant Flow|Phase I: Stage 1 (MV-NIS Alone) Dose Level 3|Patients receive 1x10^8 MV-NIS (TCID50) IV over 1 hour on day 1.
10878149|NCT00450814|FG003|Participant Flow|Phase I: Stage 1 (MV-NIS Alone) Dose Level 4|Patients receive 1x10^9 MV-NIS (TCID50) IV over 1 hour on day 1.
10878150|NCT00450814|FG004|Participant Flow|Phase I: Stage 1 (MV-NIS Alone) Dose Level 5|Patients receive 1x10^10 MV-NIS (TCID50) IV over 1 hour on day 1.
10878151|NCT00450814|FG005|Participant Flow|Phase I: Stage 1 (MV-NIS Alone) Dose Level 6|Patients receive 1x10^11 MV-NIS (TCID50) IV over 1 hour on day 1.
10878152|NCT00450814|FG006|Participant Flow|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878153|NCT00450814|FG007|Participant Flow|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878154|NCT00450814|FG008|Participant Flow|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878155|NCT00450814|FG009|Participant Flow|Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort A|Cohort A patients (relapsed or refractory multiple myeloma who have exhausted all therapeutic options) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
10878156|NCT00450814|FG010|Participant Flow|Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort B|"Cohort B patients (relapsing from VGPR or CR and have not~> received myeloma directed therapy for at least 12 weeks) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1."
10878157|NCT00450814|OG000|Outcome|Phase I: Stage 1 (MV-NIS Alone) Dose Level 1|Patients receive 1x10^6 MV-NIS (TCID50) IV over 1 hour on day 1.
10878158|NCT00450814|OG001|Outcome|Phase I: Stage 1 (MV-NIS Alone) Dose Level 2|Patients receive 1x10^7 MV-NIS (TCID50) IV over 1 hour on day 1.
10878159|NCT00450814|OG002|Outcome|Phase I: Stage 1 (MV-NIS Alone) Dose Level 3|Patients receive 1x10^8 MV-NIS (TCID50) IV over 1 hour on day 1.
10878160|NCT00450814|OG003|Outcome|Phase I: Stage 1 (MV-NIS Alone) Dose Level 4|Patients receive 1x10^9 MV-NIS (TCID50) IV over 1 hour on day 1.
10878161|NCT00450814|OG004|Outcome|Phase I: Stage 1 (MV-NIS Alone) Dose Level 5|Patients receive 1x10^10 MV-NIS (TCID50) IV over 1 hour on day 1.
10878162|NCT00450814|OG005|Outcome|Phase I: Stage 1 (MV-NIS Alone) Dose Level 6|Patients receive 1x10^11 MV-NIS (TCID50) IV over 1 hour on day 1.
10878163|NCT00450814|OG006|Outcome|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878164|NCT00450814|OG007|Outcome|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878165|NCT00450814|OG008|Outcome|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878166|NCT00450814|OG000|Outcome|Phase I (Stage 1)|Stage 1: Patients receive MV-NIS IV over 1 hour on day 1. (Closed to accrual on 12/17/2009 and reopened 10/13/2011)
10878167|NCT00450814|OG000|Outcome|Phase II (Acetaminophen + Benadryl + MV-NIS)|Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
10878168|NCT00450814|OG000|Outcome|Phase I: Stage 1 (MV-NIS Alone)|Patients receive MV-NIS IV over 1 hour on day 1. (Closed to accrual on 12/17/2009 and reopened 10/13/2011)
10878169|NCT00450814|OG001|Outcome|Phase I: Stage 2 (MV-NIS and Cyclophosphamide)|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then MV-NIS IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878170|NCT00450814|EG000|Reported Event|Phase I: Stage 1 (MV-NIS Alone) Dose Level 1|Patients receive 1x10^6 MV-NIS (TCID50) IV over 1 hour on day 1.
10878171|NCT00450814|EG001|Reported Event|Phase I: Stage 1 (MV-NIS Alone) Dose Level 2|Patients receive 1x10^7 MV-NIS (TCID50) IV over 1 hour on day 1.
10878172|NCT00450814|EG002|Reported Event|Phase I: Stage 1 (MV-NIS Alone) Dose Level 3|Patients receive 1x10^8 MV-NIS (TCID50) IV over 1 hour on day 1.
10878173|NCT00450814|EG003|Reported Event|Phase I: Stage 1 (MV-NIS Alone) Dose Level 4|Patients receive 1x10^9 MV-NIS (TCID50) IV over 1 hour on day 1.
10878174|NCT00450814|EG004|Reported Event|Phase I: Stage 1 (MV-NIS Alone) Dose Level 5|Patients receive 1x10^10 MV-NIS (TCID50) IV over 1 hour on day 1.
10878175|NCT00450814|EG005|Reported Event|Phase I: Stage 1 (MV-NIS Alone) Dose Level 6|Patients receive 1x10^11 MV-NIS (TCID50) IV over 1 hour on day 1.
10878176|NCT00450814|EG006|Reported Event|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878177|NCT00450814|EG007|Reported Event|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878178|NCT00450814|EG008|Reported Event|Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3|Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
10878179|NCT00450814|EG009|Reported Event|Phase II (Acetaminophen + Benadryl + MV-NIS)|Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
10878180|NCT00450866|BG000|Baseline|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
10878181|NCT00450866|FG000|Participant Flow|Epothilone B (Group A)|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
10878182|NCT00450866|FG001|Participant Flow|Epothilone B (Group B)|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
10878183|NCT00450866|OG000|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
10878184|NCT00450866|OG001|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
10878185|NCT00450866|OG000|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
10878186|NCT00450866|EG000|Reported Event|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
11007758|NCT01092728|OG001|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
10878187|NCT00450983|BG000|Baseline|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
10878188|NCT00450983|FG000|Participant Flow|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
10878189|NCT00450983|OG000|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
10878190|NCT00450983|EG000|Reported Event|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
10878191|NCT00451035|BG000|Baseline|Panobinostat (LBH589)|Participants were administered panobinostat 20 mg orally OD three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat were administered at the same time each morning with 240 ml of water after a fasting period of at least two hours (water was allowed). Participants could continue treatment until they experienced unacceptable toxicity or disease progression.
10878192|NCT00451035|FG000|Participant Flow|Panobinostat (LBH589)|Participants were administered panobinostat 20 milligram (mg) orally once a day (OD) three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat were administered at the same time each morning with 240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed). Participants could continue treatment until they experienced unacceptable toxicity or disease progression.
10878193|NCT00451035|OG000|Outcome|Panobinostat (LBH589)|Participants were administered panobinostat 20 mg orally OD three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat were administered at the same time each morning with 240 ml of water after a fasting period of at least two hours (water was allowed). Participants could continue treatment until they experienced unacceptable toxicity or disease progression.
10878194|NCT00451035|OG000|Outcome|Panobinostat (LBH589)|Participants were administered panobinostat 20 mg orally OD three times a week as part of a 4 week (28 day) treatment cycle. Treatment were administered at the same time each morning with 240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed). Participants could continue treatment until they experienced unacceptable toxicity or disease progression.
10878195|NCT00451035|EG000|Reported Event|Panobinostat|Participants were administered panobinostat 20 mg orally OD three times a week as part of a 4 week (28 day) treatment cycle. Treatment were administered at the same time each morning with 240 ml of water after a fasting period of at least two hours (water was allowed). Participants could continue treatment until they experienced unacceptable toxicity or disease progression.
10878196|NCT00451048|BG000|Baseline|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
10878197|NCT00451048|FG000|Participant Flow|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
10878198|NCT00451048|OG000|Outcome|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
10878199|NCT00451048|EG000|Reported Event|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
10878200|NCT00451178|BG000|Baseline|R-CHOP and Enzastaurin|"Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP and 500 mg Enzastaurin administered QD as four 125-mg tablets, with 1125-mg loading dose (3 tablets, TID) on Day 2.~R-CHOP included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~Only this arm eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included pts who had CR, CRu and/or were PET-negative. Maintenance therapy allowed, at investigator's discretion, if pts had PR and/or were PET-positive/equivocal, or pts who discontinued therapy before 6 cycles otherwise met response criteria."
10878201|NCT00451178|BG001|Baseline|R-CHOP|"Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP.~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
10878202|NCT00451178|BG002|Baseline|Total|Total of all reporting groups
10878203|NCT00451178|FG000|Participant Flow|R-CHOP and Enzastaurin|"Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP and 500 milligrams (mg) Enzastaurin administered once daily (QD) as four 125-mg tablets, with 1125-mg loading dose [3 tablets, 3 times daily (TID)] on Day 2.~R-CHOP included:~Rituximab: 375 milligrams per square meter (mg/m^2) intravenous (IV) administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~Only this arm eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included participants (pts) who had complete response (CR), CR-unconfirmed (CRu) and/or were (positron emission tomography) PET-negative. Maintenance therapy allowed, at investigator's discretion, if pts had PR and/or were PET-positive/equivocal, or pts who discontinued therapy before 6 cycles otherwise met response criteria."
10878204|NCT00451178|FG001|Participant Flow|R-CHOP|"Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP.~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
10878205|NCT00451178|OG000|Outcome|R-CHOP and Enzastaurin|"Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP and 500 mg Enzastaurin administered QD as four 125-mg tablets, with 1125-mg loading dose (3 tablets, TID) on Day 2.~R-CHOP included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~Only this arm eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included pts who had CR, CRu and/or were PET-negative. Maintenance therapy allowed, at investigator's discretion, if pts had PR and/or were PET-positive/equivocal, or pts who discontinued therapy before 6 cycles otherwise met response criteria."
10878206|NCT00451178|OG001|Outcome|R-CHOP|"Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP.~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
10878207|NCT00451178|OG000|Outcome|High Biomarker Expression (R-CHOP and Enzastaurin)|"Participants with high relative biomarker expression levels who were randomized to R-CHOP and Enzastaurin chemotherapy, up to 6 cycles, 21 days/cycle.~For each cycle, R-CHOP included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~Enzastaurin: 500 mg administered QD as four 125-mg tablets, with 1125-mg loading dose (3 tablets, TID) on Day 2.~Only R-CHOP and Enzastaurin participants eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included participants who had CR, CRu and/or were PET-negative. Maintenance therapy allowed, at investigator's discretion, if participants had PR and/or were PET-positive/equivocal, or participants who discontinued therapy before 6 cycles otherwise met response criteria."
11336503|NCT03567252|EG001|Reported Event|Non-Walking Group|Participants in this group will have no walking requirement. They will receive handouts about nutrition information and nutritional choices.
11002463|NCT01066624|OG001|Outcome|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
11002464|NCT01066624|OG002|Outcome|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
11002465|NCT01066624|EG000|Reported Event|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
11002466|NCT01066624|EG001|Reported Event|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
11002467|NCT01066624|EG002|Reported Event|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
11002468|NCT01066780|BG000|Baseline|ClearVoice|
11002469|NCT01066780|FG000|Participant Flow|Group A: Received ClearVoice MEDIUM Followed by HIGH|Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH.
11224483|NCT02360319|EG000|Reported Event|Clinician's Choice|"Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years~Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients"
11002470|NCT01066780|FG001|Participant Flow|Group B: Received ClearVoice HIGH Followed by MEDIUM|Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM.
11002471|NCT01066780|OG000|Outcome|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
11002472|NCT01066780|EG000|Reported Event|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
11002473|NCT01066793|BG000|Baseline|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002474|NCT01066793|BG001|Baseline|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002475|NCT01066793|BG002|Baseline|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002476|NCT01066793|BG003|Baseline|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002477|NCT01066793|BG004|Baseline|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002478|NCT01066793|BG005|Baseline|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002479|NCT01066793|BG006|Baseline|Total|Total of all reporting groups
11002480|NCT01066793|FG000|Participant Flow|Genotype 1 (G1)|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received Pegasys® (Pegylated Interferon [PEG-IFN] alfa-2a) or PegIntron® (PEG-IFN alfa-2b) plus ribavirin dose according to the standard of care and in line with summary of product characteristics (SPCs)/local labeling for up to 72 weeks were observed.
11002481|NCT01066793|FG001|Participant Flow|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002482|NCT01066793|FG002|Participant Flow|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002483|NCT01066793|FG003|Participant Flow|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002484|NCT01066793|FG004|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
10878208|NCT00451178|OG001|Outcome|High Biomarker Expression (R-CHOP)|"Participants with high relative biomarker expression levels who were randomized to R-CHOP chemotherapy, up to 6 cycles, 21 days/cycle.~For each cycle, R-CHOP included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
10878209|NCT00451178|OG002|Outcome|Low Biomarker Expression (R-CHOP and Enzastaurin)|"Participants with low relative biomarker expression levels who were randomized to R-CHOP and Enzastaurin chemotherapy, up to 6 cycles, 21 days/cycle.~For each cycle, R-CHOP included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~Enzastaurin: 500 mg administered QD as four 125-mg tablets, with 1125-mg loading dose (3 tablets, TID) on Day 2.~Only R-CHOP and Enzastaurin participants eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included participants who had CR, CRu and/or were PET-negative. Maintenance therapy allowed, at investigator's discretion, if participants had PR and/or were PET-positive/equivocal, or participants who discontinued therapy before 6 cycles otherwise met response criteria."
10878210|NCT00451178|OG003|Outcome|Low Biomarker Expression (R-CHOP)|"Participants with low relative biomarker expression levels who were randomized to R-CHOP chemotherapy, up to 6 cycles, 21 days/cycle.~For each cycle, R-CHOP included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
10878211|NCT00451178|EG000|Reported Event|R-CHOP and Enzastaurin|"Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP and 500 mg Enzastaurin administered QD as four 125-mg tablets, with 1125-mg loading dose (3 tablets, TID) on Day 2.~R-CHOP included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~Only this arm eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included pts who had CR, CRu and/or were PET-negative. Maintenance therapy allowed, at investigator's discretion, if pts had PR and/or were PET-positive/equivocal, or pts who discontinued therapy before 6 cycles otherwise met response criteria."
10878212|NCT00451178|EG001|Reported Event|R-CHOP|"Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP.~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
10878213|NCT00451191|BG000|Baseline|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
10878214|NCT00451191|BG001|Baseline|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
10878215|NCT00451191|BG002|Baseline|Total|Total of all reporting groups
10878216|NCT00451191|FG000|Participant Flow|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
10878217|NCT00451191|FG001|Participant Flow|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
10878218|NCT00451191|OG000|Outcome|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
10878219|NCT00451191|OG001|Outcome|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
10878220|NCT00451191|EG000|Reported Event|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
11002485|NCT01066793|FG005|Participant Flow|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
10878221|NCT00451191|EG001|Reported Event|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
10878222|NCT00451204|BG000|Baseline|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
10878223|NCT00451204|BG001|Baseline|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
10878224|NCT00451204|BG002|Baseline|Total|Total of all reporting groups
10878225|NCT00451204|FG000|Participant Flow|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
10878226|NCT00451204|FG001|Participant Flow|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
10878227|NCT00451204|OG000|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
10878228|NCT00451204|OG001|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
10878229|NCT00451204|OG001|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
10878230|NCT00451204|OG000|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
10878231|NCT00451204|OG001|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
10878232|NCT00451204|EG000|Reported Event|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
10878233|NCT00451204|EG001|Reported Event|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
10878234|NCT00451217|BG000|Baseline|Rocuronium + Sugammadex|After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
10878235|NCT00451217|BG001|Baseline|Rocuronium + Neostigmine|After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
10878236|NCT00451217|BG002|Baseline|Vecuronium + Sugammadex|After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
10878237|NCT00451217|BG003|Baseline|Vecuronium + Neostigmine|After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
10878238|NCT00451217|BG004|Baseline|Total|Total of all reporting groups
10878239|NCT00451217|FG000|Participant Flow|Rocuronium + Sugammadex|After the last dose of rocuronium, at reappearance of second twitch (T2), a dose of 2.0 mg/kg sugammadex was administered
10878240|NCT00451217|FG001|Participant Flow|Rocuronium + Neostigmine|After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
10878241|NCT00451217|FG002|Participant Flow|Vecuronium + Sugammadex|After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
10878242|NCT00451217|FG003|Participant Flow|Vecuronium + Neostigmine|After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
10878243|NCT00451217|OG000|Outcome|Rocuronium + Sugammadex|After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
10878244|NCT00451217|OG001|Outcome|Rocuronium + Neostigmine|After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
10878245|NCT00451217|OG002|Outcome|Vecuronium + Sugammadex|After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
10878246|NCT00451217|OG003|Outcome|Vecuronium + Neostigmine|After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
10878247|NCT00451217|EG000|Reported Event|Rocuronium + Sugammadex|After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
10878248|NCT00451217|EG001|Reported Event|Rocuronium + Neostigmine|After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
10878249|NCT00451217|EG002|Reported Event|Vecuronium + Sugammadex|After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
10878250|NCT00451217|EG003|Reported Event|Vecuronium + Neostigmine|After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
10878251|NCT00451282|BG000|Baseline|Intervention|Injured children receiving Stepped Preventive Care intervention
10878252|NCT00451282|BG001|Baseline|Usual Care|Injured children receiving usual care
10878253|NCT00451282|BG002|Baseline|Total|Total of all reporting groups
10878254|NCT00451282|FG000|Participant Flow|Intervention|Injured children receiving Stepped Preventive Care intervention
10878255|NCT00451282|FG001|Participant Flow|Usual Care|Injured children receiving usual care
10878256|NCT00451282|OG000|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
10878257|NCT00451282|OG001|Outcome|Usual Care|Injured children receiving usual care
10878258|NCT00451282|EG000|Reported Event|Intervention|Injured children receiving Stepped Preventive Care intervention
10878259|NCT00451282|EG001|Reported Event|Usual Care|Injured children receiving usual care
10878260|NCT00451321|BG000|Baseline|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
10878261|NCT00451321|BG001|Baseline|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
10878262|NCT00451321|BG002|Baseline|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
11002486|NCT01066793|OG000|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002487|NCT01066793|OG001|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002488|NCT01066793|OG002|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002489|NCT01066793|OG003|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002490|NCT01066793|OG004|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002491|NCT01066793|OG005|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002492|NCT01066793|OG000|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV inclusive of all Genotypes who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002493|NCT01066793|EG000|Reported Event|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002494|NCT01066793|EG001|Reported Event|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002495|NCT01066793|EG002|Reported Event|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002496|NCT01066793|EG003|Reported Event|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002497|NCT01066793|EG004|Reported Event|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002498|NCT01066793|EG005|Reported Event|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11002499|NCT01066819|BG000|Baseline|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002500|NCT01066819|BG001|Baseline|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002501|NCT01066819|BG002|Baseline|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002502|NCT01066819|BG003|Baseline|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002503|NCT01066819|BG004|Baseline|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002504|NCT01066819|BG005|Baseline|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002505|NCT01066819|BG006|Baseline|Total|Total of all reporting groups
11002506|NCT01066819|FG000|Participant Flow|Genotype 1 (G1)|Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed.
11002507|NCT01066819|FG001|Participant Flow|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002508|NCT01066819|FG002|Participant Flow|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002509|NCT01066819|FG003|Participant Flow|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002510|NCT01066819|FG004|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002511|NCT01066819|FG005|Participant Flow|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002512|NCT01066819|OG000|Outcome|Genotype 1 (G1)|Eligible Participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002513|NCT01066819|OG001|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002514|NCT01066819|OG002|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002515|NCT01066819|OG003|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002516|NCT01066819|OG004|Outcome|Genotype 5/6 (G5/6)|Participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002517|NCT01066819|OG005|Outcome|Genotype Unknown (UNK)|Participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002518|NCT01066819|OG000|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002519|NCT01066819|OG004|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002520|NCT01066819|OG005|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002521|NCT01066819|EG000|Reported Event|Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b)|Eligible participants with serologically proven CHC who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
11002522|NCT01066871|BG000|Baseline|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
11002523|NCT01066871|BG001|Baseline|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002524|NCT01066871|BG002|Baseline|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002525|NCT01066871|BG003|Baseline|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
11002526|NCT01066871|BG004|Baseline|Total|Total of all reporting groups
11002527|NCT01066871|FG000|Participant Flow|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
11002528|NCT01066871|FG001|Participant Flow|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002529|NCT01066871|FG002|Participant Flow|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002530|NCT01066871|FG003|Participant Flow|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
11002531|NCT01066871|OG000|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
11002532|NCT01066871|OG001|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002533|NCT01066871|OG002|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002534|NCT01066871|OG003|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
11002535|NCT01066871|OG000|Outcome|AS902330 10 mcg|AS902330 was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
11002536|NCT01066871|OG001|Outcome|AS902330 30 mcg|AS902330 was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002537|NCT01066871|OG002|Outcome|AS902330 100 mcg|AS902330 was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002538|NCT01066871|OG003|Outcome|Placebo|Placebo matched to sprifermin AS902330 was administered as intra-articular injection once every week for 3 consecutive weeks.
11002539|NCT01066871|OG000|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
11002540|NCT01066871|EG000|Reported Event|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
11002541|NCT01066871|EG001|Reported Event|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002542|NCT01066871|EG002|Reported Event|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
11002543|NCT01066871|EG003|Reported Event|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
11002544|NCT01066897|BG000|Baseline|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
11002545|NCT01066897|BG001|Baseline|Healthy Controls|Non depressed, non treatment comparison group from baseline
11224093|NCT02357836|EG000|Reported Event|Itraconazole|"600 mg twice daily for 10-14 days~Itraconazole: Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, Post-treatment assessments will include a skin biopsy, blood draw for the PK analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure."
11224094|NCT02357901|BG000|Baseline|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11224095|NCT02357901|BG001|Baseline|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11224096|NCT02357901|BG002|Baseline|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11224097|NCT02357901|BG003|Baseline|Total|Total of all reporting groups
11224098|NCT02357901|FG000|Participant Flow|Run-In Period|During the Run-In Period, participants were inducted onto SUBOXONE sublingual film followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information.
11224099|NCT02357901|FG001|Participant Flow|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11002546|NCT01066897|BG002|Baseline|Total|Total of all reporting groups
11224100|NCT02357901|FG002|Participant Flow|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11224484|NCT02360319|EG001|Reported Event|Aripiprazole Once Monthly|"Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years~aripiprazole long acting injectable formulation"
11002547|NCT01066897|FG000|Participant Flow|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
11002548|NCT01066897|FG001|Participant Flow|Healthy Controls|Non depressed, non treatment comparison group
11002549|NCT01066897|OG000|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
11002550|NCT01066897|OG001|Outcome|Healthy Controls Who Did Not Take Medication|
11002551|NCT01066897|OG001|Outcome|Healthy Controls|Non depressed, non-intervention comparison group
11002552|NCT01066897|OG001|Outcome|Healthy Controls|Non depressed, non treatment comparison group
11007759|NCT01092728|EG000|Reported Event|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
11002553|NCT01066897|EG000|Reported Event|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
11002554|NCT01066923|BG000|Baseline|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
11002555|NCT01066923|BG001|Baseline|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
11002556|NCT01066923|BG002|Baseline|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
11002557|NCT01066923|BG003|Baseline|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
11002558|NCT01066923|BG004|Baseline|Total|Total of all reporting groups
11002559|NCT01066923|FG000|Participant Flow|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
11002560|NCT01066923|FG001|Participant Flow|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
11002561|NCT01066923|FG002|Participant Flow|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
11002562|NCT01066923|FG003|Participant Flow|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
11002563|NCT01066923|OG000|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
11002564|NCT01066923|OG001|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
11002565|NCT01066923|OG002|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
11002566|NCT01066923|OG003|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
11002567|NCT01066923|EG000|Reported Event|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
11002568|NCT01066923|EG001|Reported Event|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
11002569|NCT01066923|EG002|Reported Event|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
11224101|NCT02357901|FG003|Participant Flow|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11224485|NCT02360371|BG000|Baseline|A118G (rs1799971-G)|This is a within-subject study wherein the same 100 participants moved from one treatment arm to the next.
10845813|NCT00270296|FG002|Participant Flow|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
11002570|NCT01066923|EG003|Reported Event|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
11002571|NCT01066936|BG000|Baseline|MIS Stem|Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. All subjects had implantation of the MIS femoral stem/modular neck during THA. DEXA was used to assess the bone ingrowth and detect significant alterations in skeletal structure that may not be visible during routine clinical assessment.
11002572|NCT01066936|FG000|Participant Flow|MIS (Mini Stem) Stem|Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during total hip arthroplasty (THA).
11002573|NCT01066936|OG000|Outcome|MIS Stem|Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
11002574|NCT01066936|OG000|Outcome|Study Population|Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
11002575|NCT01066936|OG000|Outcome|MIS Stem|Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
11002576|NCT01066936|EG000|Reported Event|MIS Stem|Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
11002577|NCT01067105|BG000|Baseline|Ciclesonide|ciclesonide HFA 160 μg once daily
11002578|NCT01067105|FG000|Participant Flow|Ciclesonide|ciclesonide HFA 160 μg once daily
11002579|NCT01067105|OG000|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
11002580|NCT01067105|EG000|Reported Event|Ciclesonide|ciclesonide HFA 160 μg once daily
11002581|NCT01067326|BG000|Baseline|Aliskiren|"150 mg Aliskiren once daily for a period of 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
11002582|NCT01067326|BG001|Baseline|Placebo|"1 pill per day by mouth for 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
11002583|NCT01067326|BG002|Baseline|Total|Total of all reporting groups
11002584|NCT01067326|FG000|Participant Flow|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
11002585|NCT01067326|FG001|Participant Flow|Placebo|1 pill per day by mouth for 4 months.
11002586|NCT01067326|OG000|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
11002587|NCT01067326|OG001|Outcome|Placebo|1 pill per day by mouth for 4 months.
11224486|NCT02360371|BG001|Baseline|A118A (rs1799971-A)|This is a within-subject study wherein the same 100 participants moved from one treatment arm to the next.
11002588|NCT01067326|EG000|Reported Event|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
11002589|NCT01067326|EG001|Reported Event|Placebo|1 pill per day by mouth for 4 months.
11002590|NCT01067339|BG000|Baseline|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
11002591|NCT01067339|BG001|Baseline|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
11002592|NCT01067339|BG002|Baseline|Total|Total of all reporting groups
11002593|NCT01067339|FG000|Participant Flow|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
11002594|NCT01067339|FG001|Participant Flow|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
11002595|NCT01067339|OG000|Outcome|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
11002596|NCT01067339|OG001|Outcome|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
11002597|NCT01067339|EG000|Reported Event|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
11002598|NCT01067339|EG001|Reported Event|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
11002599|NCT01067352|BG000|Baseline|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
11002600|NCT01067352|BG001|Baseline|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
11002601|NCT01067352|BG002|Baseline|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
11002602|NCT01067352|BG003|Baseline|Total|Total of all reporting groups
11002603|NCT01067352|FG000|Participant Flow|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
11007760|NCT01092728|EG001|Reported Event|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
11224487|NCT02360371|BG002|Baseline|Total|Total of all reporting groups
10878263|NCT00451321|BG003|Baseline|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
10878264|NCT00451321|BG004|Baseline|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
10878265|NCT00451321|BG005|Baseline|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
10878266|NCT00451321|BG006|Baseline|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
10878267|NCT00451321|BG007|Baseline|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
10878268|NCT00451321|BG008|Baseline|Total|Total of all reporting groups
10878269|NCT00451321|FG000|Participant Flow|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
10878270|NCT00451321|FG001|Participant Flow|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
10878271|NCT00451321|FG002|Participant Flow|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
10878272|NCT00451321|FG003|Participant Flow|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
10878273|NCT00451321|FG004|Participant Flow|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
10878274|NCT00451321|FG005|Participant Flow|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
10878275|NCT00451321|FG006|Participant Flow|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
10878276|NCT00451321|FG007|Participant Flow|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
10878277|NCT00451321|OG000|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
10878278|NCT00451321|OG001|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
10878279|NCT00451321|OG002|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
11002604|NCT01067352|FG001|Participant Flow|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
10878280|NCT00451321|OG003|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
10878281|NCT00451321|OG004|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
10878282|NCT00451321|OG005|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
10878283|NCT00451321|OG006|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
10878284|NCT00451321|OG007|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
10878285|NCT00451321|EG000|Reported Event|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
10878286|NCT00451321|EG001|Reported Event|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
10878287|NCT00451321|EG002|Reported Event|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
10878288|NCT00451321|EG003|Reported Event|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
10878289|NCT00451321|EG004|Reported Event|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
11007761|NCT01092767|BG000|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|
11002605|NCT01067352|FG002|Participant Flow|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
11002606|NCT01067352|OG000|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
11002607|NCT01067352|OG001|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
11002608|NCT01067352|OG002|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
11002609|NCT01067352|EG000|Reported Event|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
11002610|NCT01067352|EG001|Reported Event|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
11002611|NCT01067352|EG002|Reported Event|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
11002612|NCT01067456|BG000|Baseline|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
11002613|NCT01067456|BG001|Baseline|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.~Comprehensive Cardiothoracic Dual Source CT (DSCT) arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
11002614|NCT01067456|BG002|Baseline|Total|Total of all reporting groups
11002615|NCT01067456|FG000|Participant Flow|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
11002616|NCT01067456|FG001|Participant Flow|Comprehensive Cardiothoracic CT Arm|Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
11002617|NCT01067456|OG000|Outcome|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
11002618|NCT01067456|OG001|Outcome|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.~Comprehensive Cardiothoracic DSCT arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
11002619|NCT01067456|OG000|Outcome|Dedicated CT Arm|Standard CT either cardiac, PE or aortic dissection CT
11002620|NCT01067456|OG001|Outcome|Comprehensive Cardiothoracic CT Arm|That is the interventional arm with the new protocol
11002621|NCT01067456|EG000|Reported Event|Dedicated CT Arm|Subjects in this arm continued to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
11002622|NCT01067456|EG001|Reported Event|Comprehensive Cardiothoracic CT Arm|Subjects in this arm received a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
11002623|NCT01067469|BG000|Baseline|Standard Dose Bevacizumab|Bevacizumab 10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
11002624|NCT01067469|BG001|Baseline|Low Dose Bevacizumab + Lomustine|Bevacizumab 5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle. Lomustine starting dose of 90 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle. Due to hematologic toxicities, the starting dose was reduced to 75 mg/m2.
11224102|NCT02357901|OG000|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11002625|NCT01067469|BG002|Baseline|Total|Total of all reporting groups
11002626|NCT01067469|FG000|Participant Flow|Standard Dose Bevacizumab|Bevacizumab 10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
11002627|NCT01067469|FG001|Participant Flow|Low Dose Bevacizumab + Lomustine|Bevacizumab 5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle. Lomustine starting dose of 90 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle. Due to hematologic toxicities, the starting dose was reduced to 75 mg/m2.
11002628|NCT01067469|OG000|Outcome|Standard Dose Bevacizumab|Bevacizumab 10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
11002629|NCT01067469|OG001|Outcome|Low Dose Bevacizumab + Lomustine|Bevacizumab 5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle. Lomustine starting dose of 90 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle. Due to hematologic toxicities, the starting dose was reduced to 75 mg/m2.
11002630|NCT01067469|EG000|Reported Event|Standard Dose Bevacizumab|Bevacizumab 10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
11002631|NCT01067469|EG001|Reported Event|Low Dose Bevacizumab + Lomustine|Bevacizumab 5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle. Lomustine starting dose of 90 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle. Due to hematologic toxicities, the starting dose was reduced to 75 mg/m2.
11002632|NCT01067508|BG000|Baseline|Fiji Water|Participants are asked to consume 1 liter of this silicon-rich water (Fiji) daily for 12 weeks.
11002633|NCT01067508|BG001|Baseline|Aquafina Water|Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
11002634|NCT01067508|BG002|Baseline|Total|Total of all reporting groups
11002635|NCT01067508|FG000|Participant Flow|Fiji Water|Participants are asked to consume 1 liter of this silicon-rich water daily for 12 weeks.
11002636|NCT01067508|FG001|Participant Flow|Aquafina Water|Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
11002637|NCT01067508|OG000|Outcome|Aquafina Water|Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
11002638|NCT01067508|OG001|Outcome|Fiji Water|Participants are asked to drink 1 liter of this silicon-rich water daily for 12 weeks.
11002639|NCT01067508|EG000|Reported Event|Fiji Water|Participants are asked to consume 1 liter of this silicon-rich water (Fiji) daily for three months.
11002640|NCT01067508|EG001|Reported Event|Aquafina Water|Participants are asked to drink 1 liter of this deionized water daily for 12 weeks.
11224103|NCT02357901|OG001|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11224104|NCT02357901|OG002|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11224105|NCT02357901|EG000|Reported Event|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11002641|NCT01067716|BG000|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
11224106|NCT02357901|EG001|Reported Event|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11002642|NCT01067716|BG001|Baseline|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
11002643|NCT01067716|BG002|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
11002644|NCT01067716|BG003|Baseline|Total|Total of all reporting groups
11002645|NCT01067716|FG000|Participant Flow|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
11002646|NCT01067716|FG001|Participant Flow|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
11002647|NCT01067716|FG002|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
11002648|NCT01067716|OG000|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
11002649|NCT01067716|OG001|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
11002650|NCT01067716|OG002|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
11002651|NCT01067716|EG000|Reported Event|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
11002652|NCT01067716|EG001|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
11002653|NCT01067716|EG002|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
11002654|NCT01067768|BG000|Baseline|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
11002655|NCT01067768|BG001|Baseline|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
11002656|NCT01067768|BG002|Baseline|Total|Total of all reporting groups
11002657|NCT01067768|FG000|Participant Flow|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
11002658|NCT01067768|FG001|Participant Flow|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
11002659|NCT01067768|OG000|Outcome|Daily Review|Daily monitoring of catheter indication
11002660|NCT01067768|OG001|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
11007762|NCT01092767|FG000|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
11002661|NCT01067768|EG000|Reported Event|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
11002662|NCT01067768|EG001|Reported Event|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
11002663|NCT01067781|BG000|Baseline|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
11002664|NCT01067781|BG001|Baseline|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
11002665|NCT01067781|BG002|Baseline|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
11002666|NCT01067781|BG003|Baseline|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
11002667|NCT01067781|BG004|Baseline|Total|Total of all reporting groups
11002668|NCT01067781|FG000|Participant Flow|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
11002669|NCT01067781|FG001|Participant Flow|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
11224107|NCT02357901|EG002|Reported Event|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
11224108|NCT02357940|BG000|Baseline|Adults|Adults - 1% Colloidal Oatmeal Balm
11224109|NCT02357940|BG001|Baseline|Babies|Babies - 1% Colloidal Oatmeal Balm
11224110|NCT02357940|BG002|Baseline|Total|Total of all reporting groups
11224111|NCT02357940|FG000|Participant Flow|Adults|Adults - 1% Colloidal Oatmeal Balm
11224112|NCT02357940|FG001|Participant Flow|Babies|Babies - 1% Colloidal Oatmeal Balm
11224113|NCT02357940|OG000|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
11002670|NCT01067781|FG002|Participant Flow|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
11002671|NCT01067781|FG003|Participant Flow|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
11224114|NCT02357940|OG001|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
11224115|NCT02357940|EG000|Reported Event|Adults|Adults - 1% Colloidal Oatmeal Balm
11224116|NCT02357940|EG001|Reported Event|Babies|Babies - 1% Colloidal Oatmeal Balm
11224117|NCT02357979|BG000|Baseline|Laser & Fluoride|"In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.~Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months."
11224118|NCT02357979|BG001|Baseline|Fluoride Alone|"In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.~Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant."
11224119|NCT02357979|BG002|Baseline|Total|Total of all reporting groups
11224120|NCT02357979|FG000|Participant Flow|Laser & Fluoride|"In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.~Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months."
11224488|NCT02360371|FG000|Participant Flow|A118G (rs1799971-G)|This is a within-subject study wherein the same participants moved from one treatment arm to the next and results were analyzed posthoc as a function of genotype.
11002672|NCT01067781|OG000|Outcome|Group 1 & 2 Combined: 37.5µg LT Patch|with or without swabbing
11002673|NCT01067781|OG001|Outcome|Group 3 & 4 Combined: Placebo Patch (0µg LT)|with or without swabbing
11002674|NCT01067781|OG000|Outcome|LT Patch Without Swabbing|"Two vaccination (Day 0 and Day 14) regimen with an LT patch (no swabbing), 37.5 mcg LT~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
11002675|NCT01067781|OG001|Outcome|LT Patch With Swabbing|"Two vaccination (Day 0 and Day 14) regimen with an LT patch (with swabbing), 37.5 mcg LT~SPS:Buffer-prepared site swabbed with a 70% isopropyl alcohol pad~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
11002676|NCT01067781|OG002|Outcome|Placebo Patch Without Swabbing|"Two vaccination (Day 0 and Day 14) regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
11002677|NCT01067781|OG003|Outcome|Placebo Patch With Swabbing|"Two vaccination (Day 0 and Day 14) regimen with a placebo patch (with swabbing)~SPS:Buffer-prepared site swabbed with a 70% isopropyl alcohol pad~Placebo: Travelers' Diarrhea Vaccine System"
11002678|NCT01067781|EG000|Reported Event|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
11002679|NCT01067781|EG001|Reported Event|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
11002680|NCT01067781|EG002|Reported Event|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
11002681|NCT01067781|EG003|Reported Event|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
11002682|NCT01067846|BG000|Baseline|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
11002683|NCT01067846|BG001|Baseline|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
11002684|NCT01067846|BG002|Baseline|Total|Total of all reporting groups
11002685|NCT01067846|FG000|Participant Flow|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
11002686|NCT01067846|FG001|Participant Flow|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
11002687|NCT01067846|OG000|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
11002688|NCT01067846|OG001|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
11002689|NCT01067846|EG000|Reported Event|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
11002690|NCT01067846|EG001|Reported Event|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
11002691|NCT01067976|BG000|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
11002692|NCT01067976|FG000|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
11002693|NCT01067976|OG000|Outcome|CMRM vs UMRM|
11002694|NCT01067976|OG000|Outcome|UMRM|
11002695|NCT01067976|OG001|Outcome|CMRM|
11002696|NCT01067976|OG000|Outcome|CMRM|
11002697|NCT01067976|OG001|Outcome|CMRM vs XRM|
11002698|NCT01067976|OG002|Outcome|CMRM vs CMRM+XRM|
11002699|NCT01067976|OG000|Outcome|UMRM|Before the administration of study drug unenhanced breast MRI (UMRM) were performed.
11002700|NCT01067976|OG001|Outcome|CMRM|After the administration of study drug, enhanced breast MRI were performed.
11002701|NCT01067976|OG002|Outcome|X-ray Mammography (XRM)|
11002702|NCT01067976|OG003|Outcome|UMRM+XRM|
11002703|NCT01067976|OG004|Outcome|CMRM+XRM|
11002704|NCT01067976|OG001|Outcome|CMRM+XRM vs UMRM+XRM|
11002705|NCT01067976|OG002|Outcome|CMRM+XRM vs XRM|
11002706|NCT01067976|OG000|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
11002707|NCT01067976|OG000|Outcome|Gadobutrol (Gadavist, BAY86-4875)|
11002708|NCT01067976|EG000|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
11002709|NCT01068158|BG000|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
11002710|NCT01068158|BG001|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
11002711|NCT01068158|BG002|Baseline|Total|Total of all reporting groups
11002712|NCT01068158|FG000|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
10878290|NCT00451321|EG005|Reported Event|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
10878291|NCT00451321|EG006|Reported Event|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
10878292|NCT00451321|EG007|Reported Event|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
10878293|NCT00451451|BG000|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
10878294|NCT00451451|BG001|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10878295|NCT00451451|BG002|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10878296|NCT00451451|BG003|Baseline|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
10878297|NCT00451451|BG004|Baseline|Total|Total of all reporting groups
10878298|NCT00451451|FG000|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
10878299|NCT00451451|FG001|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10878300|NCT00451451|FG002|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10878301|NCT00451451|FG003|Participant Flow|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
10878302|NCT00451451|OG000|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
10878303|NCT00451451|OG001|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10878304|NCT00451451|OG002|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10878305|NCT00451451|OG003|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
11224489|NCT02360371|FG001|Participant Flow|A118A (rs1799971-A)|This is a within-subject study wherein the same participants moved from one treatment arm to the next and results were analyzed posthoc as a function of genotype.
10878306|NCT00451451|OG003|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
10878307|NCT00451451|EG000|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
10878308|NCT00451451|EG001|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
10878309|NCT00451451|EG002|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
10878310|NCT00451451|EG003|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
10878311|NCT00451451|EG004|Reported Event|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
10878312|NCT00451555|BG000|Baseline|Enzastaurin + Fulvestrant BID|"Participants received Enzastaurin 1125 mg loading dose then 250 mg, oral, twice daily (BID) (for a total of 500 mg), until disease progression~Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter."
10878313|NCT00451555|BG001|Baseline|Enzastaurin + Fulvestrant QD|"Participants received Enzastaurin 1125 mg loading dose then received Enzastaurin once daily (QD) regimen of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression.~Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter."
10878314|NCT00451555|BG002|Baseline|Placebo + Fulvestrant BID|"Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression.~Then, participants received placebo, oral, daily."
10878315|NCT00451555|BG003|Baseline|Total|Total of all reporting groups
10878316|NCT00451555|FG000|Participant Flow|Enzastaurin + Fulvestrant|"(Initial Therapy) Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.~(Amended Therapy) Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.~Enzastaurin Once Daily Dosing: Participants received Enzastaurin 500 mg QD. Enzastaurin Twice Daily Dosing: Participants received Enzastaurin 500 mg BID. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter."
10878317|NCT00451555|FG001|Participant Flow|Fulvestrant + Placebo|Participants received fulvestrant: 500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
10878318|NCT00451555|OG000|Outcome|Enzastaurin + Fulvestrant QD + BID|"Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.~Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.~Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.~."
11002713|NCT01068158|FG001|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
10878319|NCT00451555|OG001|Outcome|Enzastaurin + Fulvestrant BID|Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
10878320|NCT00451555|OG002|Outcome|Enzastaurin + Fulvestrant QD|Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
10878321|NCT00451555|OG003|Outcome|Fulvestrant + Placebo|Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
10878322|NCT00451555|OG000|Outcome|Enzastaurin + Fulvestrant BID + QD|"Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.~Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.~Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.~."
10878323|NCT00451555|OG001|Outcome|Enzastaurin + Fulvestrant BID|"Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression.~Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter"
10878324|NCT00451555|OG002|Outcome|Enzastaurin + Fulvestrant QD|"Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle, until disease progression.~Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter."
10878325|NCT00451555|OG003|Outcome|Placebo + Fulvestrant BID|"Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression.~Then, participants received placebo, oral, daily."
10878326|NCT00451555|OG000|Outcome|Enzastaurin + Fulvestrant QD + BID|"Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.~Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.~Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter."
10878327|NCT00451555|EG000|Reported Event|Fulvestrant + Enzastaurin (QD + BID)|"Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.~Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.~Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter."
10878328|NCT00451555|EG001|Reported Event|Fulvestrant + Enzastuarin (QD)|Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
10878329|NCT00451555|EG002|Reported Event|Fulvestrant + Enzastuarin (BID)|Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
10878330|NCT00451555|EG003|Reported Event|Fulvestrant + Placebo|Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
11224490|NCT02360371|OG000|Outcome|A118G (rs1799971-G)|This is a within-subject study wherein the same 100 participants moved from one treatment arm to the next.
10878331|NCT00451698|BG000|Baseline|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
10878332|NCT00451698|BG001|Baseline|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
10878333|NCT00451698|BG002|Baseline|Total|Total of all reporting groups
10878334|NCT00451698|FG000|Participant Flow|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
10878335|NCT00451698|FG001|Participant Flow|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
10878336|NCT00451698|OG000|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
10878337|NCT00451698|OG001|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
10878338|NCT00451698|OG000|Outcome|Acyanotic Placebo|"acyanotic placebo~acyanotic placebo: Single dose IV push"
10878339|NCT00451698|OG001|Outcome|Acyanotic Erythropoietin|"acyanotic erythropoietin~acyanotic erythropoietin: Single dose IV push"
10878340|NCT00451698|EG000|Reported Event|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
10878341|NCT00451698|EG001|Reported Event|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
11002714|NCT01068158|OG000|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
10878342|NCT00451906|BG000|Baseline|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
10878343|NCT00451906|FG000|Participant Flow|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
10878344|NCT00451906|OG000|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
10878345|NCT00451906|EG000|Reported Event|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
10878346|NCT00451958|BG000|Baseline|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
10878347|NCT00451958|BG001|Baseline|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878348|NCT00451958|BG002|Baseline|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878349|NCT00451958|BG003|Baseline|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878350|NCT00451958|BG004|Baseline|Total|Total of all reporting groups
10878351|NCT00451958|FG000|Participant Flow|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.
10879506|NCT00458237|OG001|Outcome|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10878352|NCT00451958|FG001|Participant Flow|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878353|NCT00451958|FG002|Participant Flow|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878354|NCT00451958|FG003|Participant Flow|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878355|NCT00451958|FG004|Participant Flow|Leuprolide 7.5 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~When the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study."
10878356|NCT00451958|OG000|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
10878357|NCT00451958|OG001|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878358|NCT00451958|OG002|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878359|NCT00451958|OG003|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878360|NCT00451958|OG003|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Leuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878361|NCT00451958|OG000|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10879507|NCT00458237|EG000|Reported Event|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
11002715|NCT01068158|OG001|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
11224491|NCT02360371|OG001|Outcome|A118A (rs1799971-A)|This is a within-subject study wherein the same 100 participants moved from one treatment arm to the next.
11224121|NCT02357979|FG001|Participant Flow|Fluoride Alone|"In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.~Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant."
11224492|NCT02360371|OG000|Outcome|A118G (rs1799971-G)|This is a within-subject study wherein the same participants moved from one treatment arm to the next and results were analyzed posthoc as a function of genotype.
10878362|NCT00451958|OG001|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878363|NCT00451958|OG000|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878364|NCT00451958|EG000|Reported Event|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
10878365|NCT00451958|EG001|Reported Event|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878366|NCT00451958|EG002|Reported Event|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878367|NCT00451958|EG003|Reported Event|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
10878368|NCT00452114|BG000|Baseline|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
10878369|NCT00452114|BG001|Baseline|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
10878370|NCT00452114|BG002|Baseline|Total|Total of all reporting groups
10878371|NCT00452114|FG000|Participant Flow|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
10878372|NCT00452114|FG001|Participant Flow|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
10878373|NCT00452114|OG000|Outcome|Participants in the Intervention Group (Cough In-exsufflator)|
10878374|NCT00452114|OG001|Outcome|Particpants in the Control Group (Flutter Device)|
10878375|NCT00452114|EG000|Reported Event|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
10878376|NCT00452114|EG001|Reported Event|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
10878377|NCT00452335|BG000|Baseline|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
10878378|NCT00452335|BG001|Baseline|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
10878379|NCT00452335|BG002|Baseline|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
10878380|NCT00452335|BG003|Baseline|Total|Total of all reporting groups
10878381|NCT00452335|FG000|Participant Flow|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
11002716|NCT01068158|EG000|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
11002717|NCT01068158|EG001|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
11002718|NCT01068262|BG000|Baseline|Healthy Males: Odanacatib (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
11002719|NCT01068262|BG001|Baseline|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
11002720|NCT01068262|BG002|Baseline|Healthy Postmenopausal Females: Odanacatib (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
11002721|NCT01068262|BG003|Baseline|Healthy Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
11002722|NCT01068262|BG004|Baseline|Total|Total of all reporting groups
11002723|NCT01068262|FG000|Participant Flow|Healthy Males: Odanacatib (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered once weekly (Qw) for 4 consecutive weeks
11002724|NCT01068262|FG001|Participant Flow|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
11002725|NCT01068262|FG002|Participant Flow|Healthy Postmenopausal Females: Odanacatib (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
11002726|NCT01068262|FG003|Participant Flow|Healthy Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
11002727|NCT01068262|OG000|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
11002728|NCT01068262|OG001|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
11002729|NCT01068262|OG002|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
11002730|NCT01068262|OG003|Outcome|Placebo in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
11002731|NCT01068262|OG000|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
10845814|NCT00270296|OG000|Outcome|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
11002732|NCT01068262|OG001|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
11002733|NCT01068262|OG003|Outcome|Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
11002734|NCT01068262|EG000|Reported Event|Healthy Males: Odanacatib 50 mg (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
11002735|NCT01068262|EG001|Reported Event|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks
11002736|NCT01068262|EG002|Reported Event|Postmenopausal Females: Odanacatib 50 mg (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
11002737|NCT01068262|EG003|Reported Event|Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
11002738|NCT01068418|BG000|Baseline|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
11002739|NCT01068418|FG000|Participant Flow|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
11002740|NCT01068418|OG000|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
11002741|NCT01068418|EG000|Reported Event|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
11002742|NCT01068509|BG000|Baseline|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
11002743|NCT01068509|BG001|Baseline|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
11002744|NCT01068509|BG002|Baseline|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
11002745|NCT01068509|BG003|Baseline|Total|Total of all reporting groups
11002746|NCT01068509|FG000|Participant Flow|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
11002747|NCT01068509|FG001|Participant Flow|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
11002748|NCT01068509|FG002|Participant Flow|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
11002749|NCT01068509|OG000|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
11002750|NCT01068509|OG001|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
11002751|NCT01068509|EG000|Reported Event|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
11002752|NCT01068509|EG001|Reported Event|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
11002753|NCT01068509|EG002|Reported Event|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
11002754|NCT01068548|BG000|Baseline|Arm 1|pre-implementation of computer based intervention
11002755|NCT01068548|BG001|Baseline|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
11002756|NCT01068548|BG002|Baseline|Total|Total of all reporting groups
11002757|NCT01068548|FG000|Participant Flow|Arm 1|pre-implementation of computer based intervention
11002758|NCT01068548|FG001|Participant Flow|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
11002759|NCT01068548|OG000|Outcome|Arm 1|pre-implementation of computer based intervention
11002760|NCT01068548|OG001|Outcome|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
11002761|NCT01068548|OG001|Outcome|Arm 2|"post-implementation of computer based length of stay clinical reminder~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
11002762|NCT01068548|EG000|Reported Event|Arm 1|pre-implementation of computer based intervention
11002763|NCT01068548|EG001|Reported Event|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
11002764|NCT01068600|BG000|Baseline|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11002765|NCT01068600|BG001|Baseline|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11002766|NCT01068600|BG002|Baseline|Total|Total of all reporting groups
11002767|NCT01068600|FG000|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11002768|NCT01068600|FG001|Participant Flow|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11002769|NCT01068600|OG000|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11002770|NCT01068600|OG001|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11002771|NCT01068600|EG000|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11002772|NCT01068600|EG001|Reported Event|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11002773|NCT01068626|BG000|Baseline|Rosuvastatin|
11002774|NCT01068626|BG001|Baseline|Placebo for Rosuvastatin|
11002775|NCT01068626|BG002|Baseline|Total|Total of all reporting groups
11002776|NCT01068626|FG000|Participant Flow|Rosuvastatin|
11002777|NCT01068626|FG001|Participant Flow|Placebo for Rosuvastatin|
11002778|NCT01068626|OG000|Outcome|Rosuvastatin|
10878382|NCT00452335|FG001|Participant Flow|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
11002779|NCT01068626|OG001|Outcome|Placebo for Rosuvastatin|
11002780|NCT01068626|EG000|Reported Event|Rosuvastatin|
11002781|NCT01068626|EG001|Reported Event|Placebo for Rosuvastatin|
11007763|NCT01092767|OG000|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
11007764|NCT01092767|EG000|Reported Event|1. Rescue|Rescue
11007765|NCT01092780|BG000|Baseline|All Randomized Participants|All participants who were randomized in the study.
11224493|NCT02360371|OG001|Outcome|A118A (rs1799971-A)|This is a within-subject study wherein the same participants moved from one treatment arm to the next and results were analyzed posthoc as a function of genotype.
11002782|NCT01068652|BG000|Baseline|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
11002783|NCT01068652|BG001|Baseline|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
11002784|NCT01068652|BG002|Baseline|Total|Total of all reporting groups
11002785|NCT01068652|FG000|Participant Flow|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
11002786|NCT01068652|FG001|Participant Flow|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
11002787|NCT01068652|OG000|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
11002788|NCT01068652|OG001|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
11002789|NCT01068652|EG000|Reported Event|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
11002790|NCT01068652|EG001|Reported Event|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
11002791|NCT01068665|BG000|Baseline|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002792|NCT01068665|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002793|NCT01068665|BG002|Baseline|Total|Total of all reporting groups
11002794|NCT01068665|FG000|Participant Flow|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002795|NCT01068665|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002796|NCT01068665|OG000|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002797|NCT01068665|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002798|NCT01068665|EG000|Reported Event|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002799|NCT01068665|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002800|NCT01068678|BG000|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002801|NCT01068678|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002802|NCT01068678|BG002|Baseline|Total|Total of all reporting groups
10846700|NCT00279201|OG000|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
11002803|NCT01068678|FG000|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002804|NCT01068678|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002805|NCT01068678|OG000|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002806|NCT01068678|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002807|NCT01068678|EG000|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002808|NCT01068678|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
11002809|NCT01068717|BG000|Baseline|All Treated|All participants who received study medication.
11002810|NCT01068717|FG000|Participant Flow|Treatment Schedule ADBC|(Treatment A) A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state.
11002811|NCT01068717|FG001|Participant Flow|Treatment Schedule BACD|(Treatment B) A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state.
11002812|NCT01068717|FG002|Participant Flow|Treatment Schedule CBDA|(Treatment C) A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fed state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state.
11002813|NCT01068717|FG003|Participant Flow|Treatment Schedule DCAB|(Treatment D) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state.
11002814|NCT01068717|OG000|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
11002815|NCT01068717|OG001|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
11002816|NCT01068717|OG002|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
11002817|NCT01068717|OG003|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
11002818|NCT01068717|OG000|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
10846701|NCT00279201|OG001|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
11002819|NCT01068717|OG001|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
11002820|NCT01068717|OG002|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
11002821|NCT01068717|OG003|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
11002822|NCT01068717|EG000|Reported Event|Fasted: 2.5mg Onglyza + 500mg Glucophage|
11002823|NCT01068717|EG001|Reported Event|Fasted: 2.5mg Saxa/500mg Metformin FDC|
11002824|NCT01068717|EG002|Reported Event|Fed: 2.5mg Onglyza + 500mg Glucophage|
11002825|NCT01068717|EG003|Reported Event|Fed: 2.5mg Saxa/500mg Metformin FDC|
11007766|NCT01092780|FG000|Participant Flow|MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil|Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
11002826|NCT01068730|BG000|Baseline|All Enrolled and Treated Participants|Participants who were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). Treatment A: single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment B: single oral 500-mg Glucophage tablet administered under fed condition. Treatment C: single oral 1000-mg Diabex tablet administered under fed condition.Treatment D: single oral 1000-mg Glucophage (metformin) tablet administered under fed condition.
11002827|NCT01068730|FG000|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment D (period 2): single oral 1000-mg Glucophage (metformin) tablet administered under fed condition. Treatment B (period 3): single oral 500-mg Glucophage tablet administered under fed condition. Treatment C (period 4): single oral 1000-mg Diabex tablet administered under fed condition.
11002828|NCT01068730|FG001|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): single oral 500-mg Glucophage tablet administered under fed condition. Treatment A (period 2): single oral 500-mg Diabex tablet administered under fed condition. Treatment C (period 3): single oral 1000-mg Diabex tablet administered under fed condition. Treatment D (period 4): single oral 1000-mg Glucophage tablet administered under fed condition.
11002829|NCT01068730|FG002|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): single oral 1000-mg Diabex tablet administered under fed condition. Treatment B (period 2): single oral 500-mg Glucophage tablet administered under fed condition. Treatment D (period 3): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment A (period 4): single oral 500-mg Diabex tablet administered under fed condition.
11002830|NCT01068730|FG003|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment C (period 2): single oral 1000-mg Diabex tablet administered under fed condition. Treatment A (period 3): single oral 500-mg Diabex tablet administered under fed condition. Treatment B (period 4): single oral 500-mg Glucophage tablet administered under fed condition.
11002831|NCT01068730|OG000|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
11002832|NCT01068730|OG001|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
11002833|NCT01068730|OG002|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
11002834|NCT01068730|OG003|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
11002835|NCT01068730|OG000|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
11002836|NCT01068730|OG001|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
11002837|NCT01068730|OG002|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
11002838|NCT01068730|OG003|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
11002839|NCT01068730|OG001|Outcome|Treatment B - 500 mg Glucophage|Single oral dose of 500 mg Glucophage tablet administered in the fed condition
11002840|NCT01068730|OG002|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
11002841|NCT01068730|OG003|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
11002842|NCT01068730|EG000|Reported Event|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
11002843|NCT01068730|EG001|Reported Event|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
11002844|NCT01068730|EG002|Reported Event|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
11002845|NCT01068730|EG003|Reported Event|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
11002846|NCT01068743|BG000|Baseline|All Enrolled and Treated Participants|
11002847|NCT01068743|FG000|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment D (period 2): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment B (period 3): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment C (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition.
11002848|NCT01068743|FG001|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment A (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment C (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment D (period 4): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
11002849|NCT01068743|FG002|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment B (period 2): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment D (period 3): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment A (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
11002850|NCT01068743|FG003|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment C (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment A (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment B (period 4): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition.
11002851|NCT01068743|OG000|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
11002852|NCT01068743|OG001|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
11002853|NCT01068743|OG002|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
11002854|NCT01068743|OG003|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
11002855|NCT01068743|OG000|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
11002856|NCT01068743|OG002|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition.
11002857|NCT01068743|OG003|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
11224122|NCT02357979|OG000|Outcome|Laser & Fluoride|"In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.~Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months."
11224123|NCT02357979|OG001|Outcome|Fluoride Alone|"In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.~Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant."
10878383|NCT00452335|FG002|Participant Flow|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
11002858|NCT01068743|EG000|Reported Event|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
11002859|NCT01068743|EG001|Reported Event|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
11002860|NCT01068743|EG002|Reported Event|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
11002861|NCT01068743|EG003|Reported Event|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
11002862|NCT01068769|BG000|Baseline|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
11002863|NCT01068769|FG000|Participant Flow|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
11002864|NCT01068769|OG000|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
11002865|NCT01068769|EG000|Reported Event|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
11002866|NCT01068821|BG000|Baseline|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
11002867|NCT01068821|BG001|Baseline|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
11002868|NCT01068821|BG002|Baseline|Total|Total of all reporting groups
11002869|NCT01068821|FG000|Participant Flow|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
11002870|NCT01068821|FG001|Participant Flow|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
11002871|NCT01068821|OG000|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
11002872|NCT01068821|OG001|Outcome|Gel Pad|Patient positioned on gel pad during surgery
11002873|NCT01068821|EG000|Reported Event|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
11002874|NCT01068821|EG001|Reported Event|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
11002875|NCT01068860|BG000|Baseline|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
11002876|NCT01068860|BG001|Baseline|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
11002877|NCT01068860|BG002|Baseline|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11224124|NCT02357979|EG000|Reported Event|Laser & Fluoride|"In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.~Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months."
11224494|NCT02360371|EG000|Reported Event|Placebo (Oral)|Within-subject double-blind, administration of placebo oral capsule. Order of dose randomized session days 3-5.
11002878|NCT01068860|BG003|Baseline|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002879|NCT01068860|BG004|Baseline|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002880|NCT01068860|BG005|Baseline|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11224125|NCT02357979|EG001|Reported Event|Fluoride Alone|"In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.~Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant."
11224126|NCT02358044|BG000|Baseline|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
11224127|NCT02358044|BG001|Baseline|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
11224128|NCT02358044|BG002|Baseline|Total|Total of all reporting groups
11002881|NCT01068860|BG006|Baseline|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
11002882|NCT01068860|BG007|Baseline|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
11002883|NCT01068860|BG008|Baseline|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
11002884|NCT01068860|BG009|Baseline|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
11002885|NCT01068860|BG010|Baseline|Total|Total of all reporting groups
11002886|NCT01068860|FG000|Participant Flow|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
11002887|NCT01068860|FG001|Participant Flow|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
11002888|NCT01068860|FG002|Participant Flow|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002889|NCT01068860|FG003|Participant Flow|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11224129|NCT02358044|FG000|Participant Flow|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
11224130|NCT02358044|FG001|Participant Flow|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
11224131|NCT02358044|OG000|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
11224132|NCT02358044|OG001|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
11224133|NCT02358044|EG000|Reported Event|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
11224134|NCT02358044|EG001|Reported Event|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
11224135|NCT02358135|BG000|Baseline|In-Person Model (Control)|The control arm is the in-person model. Patients randomized to the in-person arm sought psoriasis care from Primary Care Physicians (PCPs) or dermatologists in person.
11224495|NCT02360371|EG001|Reported Event|Hydromorphone (Oral) 2mg|Within-subject double-blind, administration of hydromorphone via oral capsule. Order of dose randomized session days 3-5.
11348277|NCT04194008|OG000|Outcome|Nerivio Device Treatment|"Treatment with active Nerivio device~Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
10878384|NCT00452335|OG000|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
10878385|NCT00452335|OG001|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
10878386|NCT00452335|OG002|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
10878387|NCT00452335|OG002|Outcome|24 Mch BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
10878388|NCT00452335|OG000|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
10878389|NCT00452335|OG001|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
10878390|NCT00452335|EG000|Reported Event|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
10878391|NCT00452335|EG001|Reported Event|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
10878392|NCT00452335|EG002|Reported Event|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
10878393|NCT00452348|BG000|Baseline|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
10878394|NCT00452348|BG001|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
10878395|NCT00452348|BG002|Baseline|Total|Total of all reporting groups
10878396|NCT00452348|FG000|Participant Flow|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
10878397|NCT00452348|FG001|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
10878398|NCT00452348|OG000|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
10878399|NCT00452348|OG001|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
10878400|NCT00452348|EG000|Reported Event|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
10878401|NCT00452348|EG001|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
10878402|NCT00452374|BG000|Baseline|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
10878403|NCT00452374|FG000|Participant Flow|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
10878404|NCT00452374|OG000|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
10878405|NCT00452374|EG000|Reported Event|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
10878406|NCT00452387|BG000|Baseline|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
10878407|NCT00452387|FG000|Participant Flow|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
10878408|NCT00452387|OG000|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
10878409|NCT00452387|OG000|Outcome|Imaging Response (Favorable)|
10878410|NCT00452387|OG001|Outcome|Imaging Response (Unfavorable)|
10878411|NCT00452387|EG000|Reported Event|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
10878412|NCT00452400|BG000|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10878413|NCT00452400|BG001|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10878414|NCT00452400|BG002|Baseline|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10878415|NCT00452400|BG003|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10878416|NCT00452400|BG004|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
10878417|NCT00452400|BG005|Baseline|Total|Total of all reporting groups
10878418|NCT00452400|FG000|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10878419|NCT00452400|FG001|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
11002890|NCT01068860|FG004|Participant Flow|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002891|NCT01068860|FG005|Participant Flow|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002892|NCT01068860|FG006|Participant Flow|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
11002893|NCT01068860|FG007|Participant Flow|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
11002894|NCT01068860|FG008|Participant Flow|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
11002895|NCT01068860|FG009|Participant Flow|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
11002896|NCT01068860|OG000|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
11002897|NCT01068860|OG001|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
11002898|NCT01068860|OG002|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002899|NCT01068860|OG003|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002900|NCT01068860|OG004|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002901|NCT01068860|OG005|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002902|NCT01068860|OG006|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
11002903|NCT01068860|OG007|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
11002904|NCT01068860|OG008|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
11002905|NCT01068860|OG009|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
11002906|NCT01068860|EG000|Reported Event|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
11002907|NCT01068860|EG001|Reported Event|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
11224496|NCT02360371|EG002|Reported Event|Hydromorphone (Oral) 4mg|Hydromorphone oral capsule administered in double-blind manner on Day 2 as first study drug administration. Hydromorphone 4mg dosing day was set for safety purposes and non-randomized.
11224136|NCT02358135|BG001|Baseline|Online Model (Collaborative Connected-Health)|"The intervention arm is the online, collaborative connected-health model: an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. The collaborative connected-health model was designed such that any specialist services that usually occur in person could be delivered through asynchronous online healthcare in a flexible and prompt manner. In this pragmatic trial, the PCPs could access the dermatologists online asynchronously via consultation or requesting a dermatologist to assume care of a patient's psoriasis.~Patients randomized to the online group had the option of accessing dermatologists online asynchronously. During an online visit, the patient would upload clinical images and history and transmit the information to the dermatologist. Using the telehealth platform, the dermatologist would review the transmitted information, make treatment recommendations, prescribe medications, and provide educational materials"
11224137|NCT02358135|BG002|Baseline|Total|Total of all reporting groups
11224138|NCT02358135|FG000|Participant Flow|In-Person Model (Control)|The control arm is the in-person model. Patients randomized to the in-person arm sought psoriasis care from Primary Care Physicians (PCPs) or dermatologists in person.
11224139|NCT02358135|FG001|Participant Flow|Online Model (Collaborative Connected-Health)|"The intervention arm is the online, collaborative connected-health model: an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. The collaborative connected-health model was designed such that any specialist services that usually occur in person could be delivered through asynchronous online healthcare in a flexible and prompt manner. In this pragmatic trial, the PCPs could access the dermatologists online asynchronously via consultation or requesting a dermatologist to assume care of a patient's psoriasis.~Patients randomized to the online group had the option of accessing dermatologists online asynchronously. During an online visit, the patient would upload clinical images and history and transmit the information to the dermatologist. Using the telehealth platform, the dermatologist would review the transmitted information, make treatment recommendations, prescribe medications, and provide educational materials"
11224140|NCT02358135|OG000|Outcome|In-Person Model (Control)|The control arm is the in-person model. Patients randomized to the in-person arm sought psoriasis care from Primary Care Physicians (PCPs) or dermatologists in person.
11224141|NCT02358135|OG001|Outcome|Online Model (Collaborative Connected-Health)|"The intervention arm is the online, collaborative connected-health model: an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. The collaborative connected-health model was designed such that any specialist services that usually occur in person could be delivered through asynchronous online healthcare in a flexible and prompt manner. In this pragmatic trial, the PCPs could access the dermatologists online asynchronously via consultation or requesting a dermatologist to assume care of a patient's psoriasis.~Patients randomized to the online group had the option of accessing dermatologists online asynchronously. During an online visit, the patient would upload clinical images and history and transmit the information to the dermatologist. Using the telehealth platform, the dermatologist would review the transmitted information, make treatment recommendations, prescribe medications, and provide educational materials"
11224142|NCT02358135|EG000|Reported Event|In-Person Model (Control)|The control arm is the in-person model. Patients randomized to the in-person arm sought psoriasis care from Primary Care Physicians (PCPs) or dermatologists in person.
10845815|NCT00270296|OG001|Outcome|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
10845816|NCT00270296|OG002|Outcome|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
10878420|NCT00452400|FG002|Participant Flow|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10878421|NCT00452400|FG003|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
11224143|NCT02358135|EG001|Reported Event|Online Model (Collaborative Connected-Health)|"The intervention arm is the online, collaborative connected-health model: an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. The collaborative connected-health model was designed such that any specialist services that usually occur in person could be delivered through asynchronous online healthcare in a flexible and prompt manner. In this pragmatic trial, the PCPs could access the dermatologists online asynchronously via consultation or requesting a dermatologist to assume care of a patient's psoriasis.~Patients randomized to the online group had the option of accessing dermatologists online asynchronously. During an online visit, the patient would upload clinical images and history and transmit the information to the dermatologist. Using the telehealth platform, the dermatologist would review the transmitted information, make treatment recommendations, prescribe medications, and provide educational materials"
11224144|NCT02358343|BG000|Baseline|Engagement Interview|An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home.
11224145|NCT02358343|BG001|Baseline|Control Visit|A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
11224146|NCT02358343|BG002|Baseline|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2).
11224147|NCT02358343|BG003|Baseline|Antidepressant Drug Therapy|Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects.
11002908|NCT01068860|EG002|Reported Event|Canakinumab 150 mg + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002909|NCT01068860|EG003|Reported Event|Placebo + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002910|NCT01068860|EG004|Reported Event|Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002911|NCT01068860|EG005|Reported Event|Placebo + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
11002912|NCT01068860|EG006|Reported Event|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
11002913|NCT01068860|EG007|Reported Event|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
11002914|NCT01068860|EG008|Reported Event|Canakinumab 150 mg in Patients With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
11002915|NCT01068860|EG009|Reported Event|Placebo in Patients With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
11002916|NCT01068873|BG000|Baseline|Open Label Single Arm|"Drug: lopinavir/ritonavir plus maraviroc~lopinavir/ritonavir plus maraviroc: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria."
11002917|NCT01068873|FG000|Participant Flow|Open Label Single Arm|"Drug: lopinavir/ritonavir plus maraviroc~lopinavir/ritonavir plus maraviroc: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria."
11002918|NCT01068873|OG000|Outcome|Open Label Single Arm|"Drug: lopinavir/ritonavir plus maraviroc~lopinavir/ritonavir plus maraviroc: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria."
11002919|NCT01068873|EG000|Reported Event|Open Label Single Arm|"Drug: lopinavir/ritonavir plus maraviroc~lopinavir/ritonavir plus maraviroc: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria."
11002920|NCT01068912|BG000|Baseline|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
11002921|NCT01068912|BG001|Baseline|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
11002922|NCT01068912|BG002|Baseline|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
11002923|NCT01068912|BG003|Baseline|Total|Total of all reporting groups
11002924|NCT01068912|FG000|Participant Flow|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
11002925|NCT01068912|FG001|Participant Flow|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
11002926|NCT01068912|FG002|Participant Flow|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
11002927|NCT01068912|OG000|Outcome|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
11002928|NCT01068912|OG001|Outcome|2: High Dose Favipiravir|Favipiravir:1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
11002929|NCT01068912|OG002|Outcome|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
11002930|NCT01068912|EG000|Reported Event|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
11002931|NCT01068912|EG001|Reported Event|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
11002932|NCT01068912|EG002|Reported Event|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
11002933|NCT01068964|BG000|Baseline|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
11002934|NCT01068964|BG001|Baseline|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
11002935|NCT01068964|BG002|Baseline|Total|Total of all reporting groups
11002936|NCT01068964|FG000|Participant Flow|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
11002937|NCT01068964|FG001|Participant Flow|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
11002938|NCT01068964|OG000|Outcome|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
11224148|NCT02358343|BG004|Baseline|Obsevational Cohort|Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study.
11224149|NCT02358343|BG005|Baseline|Total|Total of all reporting groups
11224150|NCT02358343|FG000|Participant Flow|Engagement Interview|An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home.
10845817|NCT00270296|EG000|Reported Event|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
10878422|NCT00452400|FG004|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
11002939|NCT01068964|OG001|Outcome|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
11002940|NCT01068964|EG000|Reported Event|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
11002941|NCT01068964|EG001|Reported Event|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
11002942|NCT01069003|BG000|Baseline|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
11002943|NCT01069003|BG001|Baseline|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
11002944|NCT01069003|BG002|Baseline|Surveillance Arm|Non randomized subjects followed for total of 24 months
11002945|NCT01069003|BG003|Baseline|Total|Total of all reporting groups
11002946|NCT01069003|FG000|Participant Flow|Placebo|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
11002947|NCT01069003|FG001|Participant Flow|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
11002948|NCT01069003|FG002|Participant Flow|Surveillance Arm|Non randomized subjects followed for total of 24 months
11002949|NCT01069003|OG000|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
11002950|NCT01069003|OG001|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
11224151|NCT02358343|FG001|Participant Flow|Control Visit|A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
11224152|NCT02358343|FG002|Participant Flow|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT is administered while the patient is undergoing hemodialysis unless alternative arrangements preferred by participant. During the course of intervention, study subjects undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12).
11224153|NCT02358343|FG003|Participant Flow|Antidepressant Drug Therapy|Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This protocol establishes the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks.
11224497|NCT02360371|EG003|Reported Event|Hydromorphone (Oral) 8mg|Within-subject double-blind, administration of hydromorphone via oral capsule. Order of dose randomized session days 3-5.
10878423|NCT00452400|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10878424|NCT00452400|OG001|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10878425|NCT00452400|OG002|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10878426|NCT00452400|OG003|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10878427|NCT00452400|OG004|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
10878428|NCT00452400|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10878429|NCT00452400|EG001|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10878430|NCT00452400|EG002|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10878431|NCT00452400|EG003|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10878432|NCT00452400|EG004|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
10878433|NCT00452413|BG000|Baseline|Phase 1, Dose 1 (Enzastaurin 250 mg, Erlotinib 150 mg)|"Enzastaurin: 500 mg enzastaurin loading dose (250 mg BID) administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 250 mg dose administered QD.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878434|NCT00452413|BG001|Baseline|Phase 1, Dose 2 (Enzastaurin 500 mg, Erlotinib 150 mg)|"Enzastaurin: 1125 mg enzastaurin loading dose (375 mg TID) administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 500 mg dose administered QD.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878435|NCT00452413|BG002|Baseline|Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)|"Enzastaurin: 1125 mg enzastaurin loading dose (375 mg TID) administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 500 mg total daily dose administered orally using either a BID or QD schedule.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878436|NCT00452413|BG003|Baseline|Total|Total of all reporting groups
10878437|NCT00452413|FG000|Participant Flow|Phase 1, Dose 1 (Enzastaurin 250 mg, Erlotinib 150 mg)|"Enzastaurin: 500 milligram (mg) enzastaurin loading dose [250 mg twice daily (BID)] administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 250 mg dose administered once daily (QD).~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878438|NCT00452413|FG001|Participant Flow|Phase 1, Dose 2 (Enzastaurin 500 mg, Erlotinib 150 mg)|"Enzastaurin: 1125 mg enzastaurin loading dose [375 mg 3 times daily (TID)] administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 500 mg dose administered QD.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878439|NCT00452413|FG002|Participant Flow|Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)|"Enzastaurin: 1125 mg enzastaurin loading dose (375 mg TID) administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 500 mg total daily dose administered orally using either a BID or QD schedule.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878440|NCT00452413|OG000|Outcome|Phase 1, Dose 1 and 2 (Enzastaurin and Erlotinib)|"Enzastaurin: Either 500 mg or 1125 mg enzastaurin loading dose administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, either 250 mg or 500 mg dose administered QD.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878441|NCT00452413|OG000|Outcome|Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)|"Enzastaurin: 1125 mg enzastaurin loading dose (375 mg TID) administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 500 mg total daily dose administered orally using either a BID or QD schedule.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878442|NCT00452413|OG000|Outcome|Phase 1, Dose 1 (Enzastaurin 250 mg, Erlotinib 150 mg)|"Enzastaurin: 500 mg enzastaurin loading dose (250 mg BID) administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 250 mg dose administered QD.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878443|NCT00452413|OG001|Outcome|Phase 1, Dose 2 (Enzastaurin 500 mg, Erlotinib 150 mg)|"Enzastaurin: 1125 mg enzastaurin loading dose (375 mg TID) administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 500 mg dose administered QD.~Erlotinib: 150 mg dose of erlotinib administered orally QD.~Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878444|NCT00452413|EG000|Reported Event|Phase 1, Dose 1 (Enzastaurin 250 mg, Erlotinib 150 mg)|"Enzastaurin: 500 milligram (mg) enzastaurin loading dose [250 mg twice daily (BID)] administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 250 mg dose administered once daily (QD).~Erlotinib: 150 mg dose of erlotinib administered orally QD. Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878445|NCT00452413|EG001|Reported Event|Phase 1, Dose 2 (Enzastaurin 500 mg, Erlotinib 150 mg)|"Enzastaurin: 1125 mg enzastaurin loading dose [375 mg 3 times daily (TID)] administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 500 mg dose administered QD.~Erlotinib: 150 mg dose of erlotinib administered orally QD. Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
11002951|NCT01069003|OG002|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
11002952|NCT01069003|OG000|Outcome|Placebo Arm|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
10878446|NCT00452413|EG002|Reported Event|Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)|"Enzastaurin: 1125 mg enzastaurin loading dose (375 mg TID) administered orally on Day 1 of a 28-day cycle. Day 2 through Day 28, 500 mg total daily dose administered orally using either a BID or QD schedule.~Erlotinib: 150 mg dose of erlotinib administered orally QD. Treatment continued until disease progression, unacceptable toxicity, or study withdrawal criteria were met."
10878447|NCT00452426|BG000|Baseline|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
10878448|NCT00452426|BG001|Baseline|Current Standard of Care|Site's current standard used for delivery of sedation
10878449|NCT00452426|BG002|Baseline|Total|Total of all reporting groups
10878450|NCT00452426|FG000|Participant Flow|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
10878451|NCT00452426|FG001|Participant Flow|Current Standard of Care|Site's current standard used for delivery of sedation
10878452|NCT00452426|OG000|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
10878453|NCT00452426|OG001|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
10878454|NCT00452426|EG000|Reported Event|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
10878455|NCT00452426|EG001|Reported Event|Current Standard of Care|Site's current standard used for delivery of sedation
10878456|NCT00452439|BG000|Baseline|Actonel|"Actonel (Risedronate) + Vitamin D + Calcium~Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months."
10878457|NCT00452439|BG001|Baseline|Placebo|"Placebo + Vitamin D + Calcium~Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months."
10878458|NCT00452439|BG002|Baseline|Total|Total of all reporting groups
10878459|NCT00452439|FG000|Participant Flow|Actonel|"Actonel (Risedronate) + Vitamin D + Calcium~Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months."
10878460|NCT00452439|FG001|Participant Flow|Placebo|"Placebo + Vitamin D + Calcium~Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months."
10878461|NCT00452439|OG000|Outcome|Actonel|"Actonel (Risedronate) + Vitamin D + Calcium~Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months."
10878462|NCT00452439|OG001|Outcome|Placebo|"Placebo + Vitamin D + Calcium~Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months."
10878463|NCT00452439|EG000|Reported Event|Actonel|"Actonel (Risedronate) + Vitamin D + Calcium~Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months."
10878464|NCT00452439|EG001|Reported Event|Placebo|"Placebo + Vitamin D + Calcium~Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months."
10878465|NCT00452452|BG000|Baseline|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
10878466|NCT00452452|BG001|Baseline|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
10878467|NCT00452452|BG002|Baseline|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
10878468|NCT00452452|BG003|Baseline|Total|Total of all reporting groups
10878469|NCT00452452|FG000|Participant Flow|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
10878470|NCT00452452|FG001|Participant Flow|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
10878471|NCT00452452|FG002|Participant Flow|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
10878472|NCT00452452|OG000|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
10878473|NCT00452452|OG001|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
10878474|NCT00452452|OG002|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
10878475|NCT00452452|OG000|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
10878476|NCT00452452|OG001|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
10878477|NCT00452452|OG002|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
11224498|NCT02360397|BG000|Baseline|Ranolazine|"Ranolazine 1000 mg tablet twice daily for 30 days~ranolazine: Ranolazine 1000 mg tablet twice daily for 30 days"
11002953|NCT01069003|OG001|Outcome|Thienopyridine Therapy|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
11002954|NCT01069003|EG000|Reported Event|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
11002955|NCT01069003|EG001|Reported Event|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
11002956|NCT01069003|EG002|Reported Event|Surveillance Arm|Non randomized subjects followed through 24 months
11002957|NCT01069172|BG000|Baseline|FS Laser Surgery and CCC Surgery|"Each eye underwent either:~Femtosecond assissisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device (the Catalys System is used for FS Laser Surgery and is an ophthalmic surgical laser system intended for use in cataract surgery).~OR~Ultrasound (U/S) cataract surgery and CCC (continuous curvilinear capsulorhexis), subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
11002958|NCT01069172|FG000|Participant Flow|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
11002959|NCT01069172|FG001|Participant Flow|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC)~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
11002960|NCT01069172|OG000|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
11002961|NCT01069172|OG001|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC and U/S Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
11002962|NCT01069172|OG001|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
11002963|NCT01069172|EG000|Reported Event|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
11002964|NCT01069172|EG001|Reported Event|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
11002965|NCT01069185|BG000|Baseline|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
11002966|NCT01069185|BG001|Baseline|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
11002967|NCT01069185|BG002|Baseline|Total|Total of all reporting groups
11002968|NCT01069185|FG000|Participant Flow|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
10846702|NCT00279201|OG002|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
11002969|NCT01069185|FG001|Participant Flow|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
11002970|NCT01069185|OG000|Outcome|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
11002971|NCT01069185|OG001|Outcome|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
11002972|NCT01069185|EG000|Reported Event|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
11002973|NCT01069185|EG001|Reported Event|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
11002974|NCT01069289|BG000|Baseline|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
11002975|NCT01069289|BG001|Baseline|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
11002976|NCT01069289|BG002|Baseline|Total|Total of all reporting groups
11002977|NCT01069289|FG000|Participant Flow|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
11002978|NCT01069289|FG001|Participant Flow|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
11002979|NCT01069289|OG000|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
11002980|NCT01069289|OG001|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
11002981|NCT01069289|EG000|Reported Event|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
11002982|NCT01069289|EG001|Reported Event|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
11002983|NCT01069315|BG000|Baseline|Normal Saline and High Pressure|"Irrigation with normal saline delivered at high pressure~Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.~Type of fluid lavage pressure: Comparison of low pressure vs. high pressure."
11002984|NCT01069315|BG001|Baseline|Soap Solution and High Pressure|"Irrigation with soap solution delivered at high pressure~Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.~Type of fluid lavage pressure: Comparison of low pressure vs. high pressure."
11002985|NCT01069315|BG002|Baseline|Normal Saline and Low Pressure|"Irrigation with saline solution delivered at low pressure~Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.~Type of fluid lavage pressure: Comparison of low pressure vs. high pressure."
11002986|NCT01069315|BG003|Baseline|Soap Solution and Low Pressure|"Irrigation with soap solution delivered at low pressure~Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.~Type of fluid lavage pressure: Comparison of low pressure vs. high pressure."
11002987|NCT01069315|BG004|Baseline|Total|Total of all reporting groups
11002988|NCT01069315|FG000|Participant Flow|Normal Saline and High Pressure|"Irrigation with normal saline delivered at high pressure~Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.~Type of fluid lavage pressure: Comparison of low pressure vs. high pressure."
11002989|NCT01069315|FG001|Participant Flow|Soap Solution and High Pressure|"Irrigation with soap solution delivered at high pressure~Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.~Type of fluid lavage pressure: Comparison of low pressure vs. high pressure."
11002990|NCT01069315|FG002|Participant Flow|Normal Saline and Low Pressure|"Irrigation with saline solution delivered at low pressure~Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.~Type of fluid lavage pressure: Comparison of low pressure vs. high pressure."
11002991|NCT01069315|FG003|Participant Flow|Soap Solution and Low Pressure|"Irrigation with soap solution delivered at low pressure~Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.~Type of fluid lavage pressure: Comparison of low pressure vs. high pressure."
11002992|NCT01069315|OG000|Outcome|Soap, Low Pressure|
11002993|NCT01069315|OG001|Outcome|Soap, High Pressure|
10845818|NCT00270296|EG001|Reported Event|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
11002994|NCT01069315|OG002|Outcome|Saline, Low Pressure|
11002995|NCT01069315|OG003|Outcome|Saline, High Pressure|
11002996|NCT01069315|OG000|Outcome|Soap|
11002997|NCT01069315|OG001|Outcome|Saline|
11002998|NCT01069315|OG000|Outcome|High Pressure|
11002999|NCT01069315|OG001|Outcome|Low Pressure|
11003000|NCT01069315|EG000|Reported Event|Soap, Low Pressure|
11003001|NCT01069315|EG001|Reported Event|Soap, High Pressure|
11003002|NCT01069315|EG002|Reported Event|Saline, Low Pressure|
11003003|NCT01069315|EG003|Reported Event|Saline, High Pressure|
11003004|NCT01069341|BG000|Baseline|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
11003005|NCT01069341|FG000|Participant Flow|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
11003006|NCT01069341|OG000|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
11003007|NCT01069341|EG000|Reported Event|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
11003008|NCT01069354|BG000|Baseline|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same 102 participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
11003009|NCT01069354|FG000|Participant Flow|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same 102 participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
11003010|NCT01069354|OG000|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
11003011|NCT01069354|OG001|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
11003012|NCT01069354|OG000|Outcome|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
11003013|NCT01069354|OG000|Outcome|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and without 3% lidocaine hydrochloride (HCl)"
11003014|NCT01069354|EG000|Reported Event|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
11003015|NCT01069354|EG001|Reported Event|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
11003016|NCT01069419|BG000|Baseline|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
11003017|NCT01069419|FG000|Participant Flow|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
11224154|NCT02358343|FG004|Participant Flow|Observational Cohort|Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study will be invited to participate in the prospective observational cohort for serial assessment of depressive symptoms.These subjects will only undergo assessment of severity of depressive symptoms at weeks 0, 6, and 12 using QIDS-C.
11224155|NCT02358343|OG000|Outcome|Engagement Interview|"Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.~Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well."
11224156|NCT02358343|OG001|Outcome|Control Visit|Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
11224157|NCT02358343|OG000|Outcome|Cognitive Behavioral Therapy|"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.~Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT will be administered while the patient is undergoing hemodialysis; however, alternative arrangements will be made upon individual patient's preferences.~Cognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking."
11224158|NCT02358343|OG001|Outcome|Antidepressant Drug Therapy|"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol.~Antidepressant Drug Therapy: The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This will help establish the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The FIBSER scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d,"
11003018|NCT01069419|OG000|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
11003019|NCT01069419|EG000|Reported Event|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
11003020|NCT01069484|BG000|Baseline|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months.
11003021|NCT01069484|BG001|Baseline|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention.
11003022|NCT01069484|BG002|Baseline|Total|Total of all reporting groups
11007767|NCT01092780|FG001|Participant Flow|MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo|Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
11007768|NCT01092780|FG002|Participant Flow|Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg|Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
11224159|NCT02358343|OG002|Outcome|Observational Cohort|Participants not accepting treatment but consented to be followed.
11224160|NCT02358343|OG000|Outcome|Cognitive Behavioral Therapy|"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.~Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."
11224161|NCT02358343|OG001|Outcome|Antidepressant Drug Therapy|The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol.
11003023|NCT01069484|FG000|Participant Flow|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the pelvic floor muscle (PFM) correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months. The PFM exercise protocol followed general principles for strength training; 3 sets 8-12 contractions close to maximum (Bø et al 1990, Haskell 2007). The participants are provided with a DVD of the program (www.corewellness.co.uk). Training adherence at home was recorded in a training diary whereas the physical therapist recorded group session adherence. Training participants were continuously motivated by the physical therapist to keep up their adherence to training classes and home training, and high performance during training was strongly emphasised.
11003024|NCT01069484|FG001|Participant Flow|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the control group participants received no further intervention. They were not discouraged from doing PFMT on their own.
11003025|NCT01069484|OG000|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
11003026|NCT01069484|OG001|Outcome|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
11003027|NCT01069484|OG001|Outcome|Control|Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the control group received no further intervention..
11003028|NCT01069484|EG000|Reported Event|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
11003029|NCT01069484|EG001|Reported Event|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
11003030|NCT01069510|BG000|Baseline|Placebo|"Patients will receive placebo~Placebo: Placebo daily for 12 months"
11003031|NCT01069510|BG001|Baseline|Spironolactone|"Spironolactone 25 mg daily~Spironolactone 25mg: Spironolactone 25 mg daily for 12 months"
11003032|NCT01069510|BG002|Baseline|Total|Total of all reporting groups
11003033|NCT01069510|FG000|Participant Flow|Placebo|"Patients will receive placebo~Placebo: Placebo daily for 12 months"
11003034|NCT01069510|FG001|Participant Flow|Spironolactone|"Spironolactone 25 mg daily~Spironolactone 25mg: Spironolactone 25 mg daily for 12 months"
11003035|NCT01069510|OG000|Outcome|Placebo|"Patients will receive placebo~Placebo: Placebo daily for 12 months"
11003036|NCT01069510|OG001|Outcome|Spironolactone|"Spironolactone 25 mg daily~Spironolactone 25mg: Spironolactone 25 mg daily for 12 months"
11003037|NCT01069510|EG000|Reported Event|Placebo|"Patients will receive placebo~Placebo: Placebo daily for 12 months"
11003038|NCT01069510|EG001|Reported Event|Spironolactone|"Spironolactone 25 mg daily~Spironolactone 25mg: Spironolactone 25 mg daily for 12 months"
11003039|NCT01069523|BG000|Baseline|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
11003040|NCT01069523|BG001|Baseline|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
11003041|NCT01069523|BG002|Baseline|Total|Total of all reporting groups
11003042|NCT01069523|FG000|Participant Flow|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
11003043|NCT01069523|FG001|Participant Flow|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
11003044|NCT01069523|OG000|Outcome|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
11003045|NCT01069523|OG001|Outcome|Guanfacine|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
11003046|NCT01069523|OG000|Outcome|Placebo|Pill placebo
11003047|NCT01069523|OG001|Outcome|Guanfacine|Blinded guanfacine capsule
11003048|NCT01069523|EG000|Reported Event|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
11003049|NCT01069523|EG001|Reported Event|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
11003050|NCT01069562|BG000|Baseline|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
11003051|NCT01069562|BG001|Baseline|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
11003052|NCT01069562|BG002|Baseline|Total|Total of all reporting groups
11003053|NCT01069562|FG000|Participant Flow|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
11003054|NCT01069562|FG001|Participant Flow|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
11003055|NCT01069562|OG000|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
11003056|NCT01069562|OG001|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
11003057|NCT01069562|EG000|Reported Event|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
11003058|NCT01069562|EG001|Reported Event|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
11003059|NCT01069627|BG000|Baseline|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
11003060|NCT01069627|FG000|Participant Flow|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 and fotemustine 100 mg per square meter (mg/m^2) IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
11003061|NCT01069627|OG000|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
11003062|NCT01069627|EG000|Reported Event|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
11003063|NCT01069705|BG000|Baseline|Tobramycin Inhalation Powder (TIPnew)|Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.
11003064|NCT01069705|FG000|Participant Flow|Tobramycin Inhalation Powder (TIPnew)|Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.
11003065|NCT01069705|OG000|Outcome|Tobramycin Inhalation Powder (TIPnew)|Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.
11003066|NCT01069705|EG000|Reported Event|Tobramycin Inhalation Powder (TIPnew)|Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.
11003067|NCT01069900|BG000|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
11003068|NCT01069900|BG001|Baseline|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
11003069|NCT01069900|BG002|Baseline|Total|Total of all reporting groups
11003070|NCT01069900|FG000|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
11003071|NCT01069900|FG001|Participant Flow|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
11224162|NCT02358343|EG000|Reported Event|Cognitive Behavioral Therapy|The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2).
11224163|NCT02358343|EG001|Reported Event|Antidepressant Drug Therapy|The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol.
11224164|NCT02358369|BG000|Baseline|Placebo Ocular Insert + Timolol 0.5%|Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks.
11224165|NCT02358369|BG001|Baseline|2.2 mg Bimatoprost Ocular Insert|Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
11224166|NCT02358369|BG002|Baseline|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
11224167|NCT02358369|BG003|Baseline|Total|Total of all reporting groups
11224168|NCT02358369|FG000|Participant Flow|Washout + Placebo Ocular Insert|Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization.
11224169|NCT02358369|FG001|Participant Flow|Placebo Ocular Insert + Timolol 0.5% (Period A/B)|Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
11224170|NCT02358369|FG002|Participant Flow|2.2 mg Bimatoprost Ocular Insert (Period A/B)|Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
10878478|NCT00452452|OG003|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
10878479|NCT00452452|OG004|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
10878480|NCT00452452|OG005|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
10878481|NCT00452452|EG000|Reported Event|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
10878482|NCT00452452|EG001|Reported Event|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
10878483|NCT00452452|EG002|Reported Event|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
10878484|NCT00452530|BG000|Baseline|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10878485|NCT00452530|BG001|Baseline|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
10878486|NCT00452530|BG002|Baseline|Total|Total of all reporting groups
10878487|NCT00452530|FG000|Participant Flow|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10878488|NCT00452530|FG001|Participant Flow|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
10878489|NCT00452530|OG000|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10878490|NCT00452530|OG001|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
10878491|NCT00452530|OG000|Outcome|Apixaban, 2.5 mg BID|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10878492|NCT00452530|OG001|Outcome|Enoxaparin, 40 mg QD|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
11224171|NCT02358369|FG003|Participant Flow|13 mg Bimatoprost Ocular Insert (Period A/B)|Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
11224172|NCT02358369|FG004|Participant Flow|13 mg Bimatoprost Ocular Insert (Period C)|Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert for 12 weeks in Period C (Week 12 to 24).
11224499|NCT02360397|FG000|Participant Flow|Ranolazine|"Ranolazine 1000 mg tablet twice daily for 30 days~ranolazine: Ranolazine 1000 mg tablet twice daily for 30 days"
11224500|NCT02360397|OG000|Outcome|Ranolazine|Ranolazine 1000 mg tablet twice daily for 30 days
11003072|NCT01069900|OG000|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
11003073|NCT01069900|OG001|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
11003074|NCT01069900|EG000|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.
11003075|NCT01069900|EG001|Reported Event|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
11003076|NCT01069939|BG000|Baseline|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
11003077|NCT01069939|BG001|Baseline|Placebo|Placebo once daily oral
11003078|NCT01069939|BG002|Baseline|Total|Total of all reporting groups
11003079|NCT01069939|FG000|Participant Flow|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
11003080|NCT01069939|FG001|Participant Flow|Placebo|Placebo once daily oral
11003081|NCT01069939|OG000|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
11003082|NCT01069939|OG001|Outcome|Placebo|Placebo once daily oral
11003083|NCT01069939|EG000|Reported Event|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
11003084|NCT01069939|EG001|Reported Event|Placebo|Placebo once daily oral
11003085|NCT01070043|BG000|Baseline|Amlodipine 5mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
11003086|NCT01070043|BG001|Baseline|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
11003087|NCT01070043|BG002|Baseline|Total|Total of all reporting groups
11224173|NCT02358369|OG000|Outcome|Placebo Ocular Insert + Timolol 0.5% (Period A/B)|Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
11003088|NCT01070043|FG000|Participant Flow|Run-In Valsartan 80 mg|During run-in period, oral valsartan 80 mg once daily for 4 weeks.
11003089|NCT01070043|FG001|Participant Flow|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
11003090|NCT01070043|FG002|Participant Flow|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
11003091|NCT01070043|OG000|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
11003092|NCT01070043|OG001|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
11003093|NCT01070043|EG000|Reported Event|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
11003094|NCT01070043|EG001|Reported Event|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
11003095|NCT01070095|BG000|Baseline|Electronic Asthma Action Plan System - Patients|All eligible unique patients from clinicians who consented to the study
11003096|NCT01070095|FG000|Participant Flow|Electronic Asthma Action Plan System - Clinicians|All clinicians who consented to the study, who were invited to use the electronic asthma action plan system for their eligible patients
11003097|NCT01070095|FG001|Participant Flow|Electronic Asthma Action Plan System - Patients|Eligible patients from clinicians who consented to the study
11003098|NCT01070095|OG000|Outcome|Baseline Period|12 months pre-intervention
11003099|NCT01070095|OG001|Outcome|Intervention Period|12 months post-intervention (eAAPS)
11003100|NCT01070095|OG000|Outcome|Intervention Period|12 months post-intervention (eAAPS)
11003101|NCT01070095|EG000|Reported Event|Baseline|12 months pre-intervention
11003102|NCT01070095|EG001|Reported Event|Intervention|12 months post-intervention (eAAPS)
11003103|NCT01070173|BG000|Baseline|Short Stature|Poor linear growth
11003104|NCT01070173|BG001|Baseline|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive)
11003105|NCT01070173|BG002|Baseline|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms
11003106|NCT01070173|BG003|Baseline|Total|Total of all reporting groups
11003107|NCT01070173|FG000|Participant Flow|Short Stature|Poor linear growth Group
11003108|NCT01070173|FG001|Participant Flow|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
11003109|NCT01070173|FG002|Participant Flow|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
11003110|NCT01070173|OG000|Outcome|Short Stature|Poor linear growth Group
11003111|NCT01070173|OG001|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
11003112|NCT01070173|OG002|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
11003113|NCT01070173|EG000|Reported Event|Short Stature|Poor linear growth Group
11003114|NCT01070173|EG001|Reported Event|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
11003115|NCT01070173|EG002|Reported Event|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
11224501|NCT02360397|OG000|Outcome|Effect of Ranolazine on Cardiac Ischemia|Ranolazine 1000 mg tablet twice daily for 30 days
11224174|NCT02358369|OG001|Outcome|2.2 mg Bimatoprost Ocular Insert (Period A/B)|Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
11224175|NCT02358369|OG002|Outcome|13 mg Bimatoprost Ocular Insert (Period A/B)|Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
11224176|NCT02358369|OG000|Outcome|13 mg Bimatoprost Ocular Insert (Period C)|Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks in Period C (Week 12 to Week 24).
11224177|NCT02358369|EG000|Reported Event|Washout + Placebo Ocular Insert|Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization.
11224178|NCT02358369|EG001|Reported Event|Placebo Ocular Insert + Timolol 0.5%|Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks.
10878493|NCT00452530|OG000|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
10878494|NCT00452530|OG001|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
10878495|NCT00452530|EG000|Reported Event|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
10878496|NCT00452530|EG001|Reported Event|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
10878497|NCT00452543|BG000|Baseline|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
10878498|NCT00452543|BG001|Baseline|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
10878499|NCT00452543|BG002|Baseline|Total|Total of all reporting groups
10878500|NCT00452543|FG000|Participant Flow|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
10878501|NCT00452543|FG001|Participant Flow|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
10878502|NCT00452543|OG000|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
10878503|NCT00452543|OG001|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
11003116|NCT01070303|BG000|Baseline|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
10878504|NCT00452543|EG000|Reported Event|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
10878505|NCT00452543|EG001|Reported Event|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
10878506|NCT00452673|BG000|Baseline|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
10878507|NCT00452673|BG001|Baseline|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
10878508|NCT00452673|BG002|Baseline|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
10878509|NCT00452673|BG003|Baseline|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
10878510|NCT00452673|BG004|Baseline|Total|Total of all reporting groups
10878511|NCT00452673|FG000|Participant Flow|50 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
10878512|NCT00452673|FG001|Participant Flow|70 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
11003117|NCT01070303|BG001|Baseline|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
11003118|NCT01070303|BG002|Baseline|Total|Total of all reporting groups
11003119|NCT01070303|FG000|Participant Flow|All Participants in Open-Label Extension of Study M02-433|Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497).
11003120|NCT01070303|OG000|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
11003121|NCT01070303|OG001|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
11003122|NCT01070303|OG000|Outcome|Change From Baseline-Week 104|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
11003123|NCT01070303|OG001|Outcome|Change From Baseline-Week 152|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
11003124|NCT01070303|OG002|Outcome|Change From Baseline-Week 200|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
11003125|NCT01070303|OG003|Outcome|Change From Baseline-Week 248|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
11003126|NCT01070303|EG000|Reported Event|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
11003127|NCT01070303|EG001|Reported Event|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
11003128|NCT01070316|BG000|Baseline|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
11003129|NCT01070316|FG000|Participant Flow|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
11003130|NCT01070316|OG000|Outcome|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
11003131|NCT01070316|EG000|Reported Event|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
11224179|NCT02358369|EG002|Reported Event|2.2 mg Bimatoprost Ocular Insert|Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
11224180|NCT02358369|EG003|Reported Event|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
11224181|NCT02358473|BG000|Baseline|Mogamulizumab + Docetaxel|Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
11224182|NCT02358473|FG000|Participant Flow|Mogamulizumab + Docetaxel|Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
11224183|NCT02358473|OG000|Outcome|Mogamulizumab + Docetaxel|Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
11224184|NCT02358473|EG000|Reported Event|Mogamulizumab + Docetaxel|Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
11224185|NCT02358603|BG000|Baseline|Case Group|At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen.
11224186|NCT02358603|BG001|Baseline|Control Group|Each subject of the control group will do the same test and examination with the subjects in the case group.
11224187|NCT02358603|BG002|Baseline|Total|Total of all reporting groups
10878513|NCT00452673|FG002|Participant Flow|70 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
10878514|NCT00452673|FG003|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
10878515|NCT00452673|FG004|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Expansion)|No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for the dose expansion period in order to provide additional information regarding good tolerance of extended treatment. An additional 21 participants were treated in this arm in the Dose Expansion Period.
10878516|NCT00452673|OG000|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
10878517|NCT00452673|OG001|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
10878518|NCT00452673|OG002|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
11003132|NCT01070329|BG000|Baseline|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
11003133|NCT01070329|BG001|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
11003134|NCT01070329|BG002|Baseline|Total|Total of all reporting groups
10878519|NCT00452673|OG003|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
10878520|NCT00452673|OG002|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
10879508|NCT00458237|EG001|Reported Event|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10879509|NCT00458237|EG002|Reported Event|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
10878521|NCT00452673|EG000|Reported Event|50 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
10878522|NCT00452673|EG001|Reported Event|70 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
10878523|NCT00452673|EG002|Reported Event|70 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
10878524|NCT00452673|EG003|Reported Event|100 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
10878525|NCT00452699|BG000|Baseline|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
10878526|NCT00452699|BG001|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
10878527|NCT00452699|BG002|Baseline|Total|Total of all reporting groups
10878528|NCT00452699|FG000|Participant Flow|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
10878529|NCT00452699|FG001|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
10878530|NCT00452699|OG000|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
10878531|NCT00452699|OG001|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
10878532|NCT00452699|EG000|Reported Event|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
10878533|NCT00452699|EG001|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
10878534|NCT00452790|BG000|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
10878535|NCT00452790|BG001|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
10878536|NCT00452790|BG002|Baseline|Total|Total of all reporting groups
10878537|NCT00452790|FG000|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
10878538|NCT00452790|FG001|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
10878539|NCT00452790|OG000|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
10878540|NCT00452790|OG001|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
10878541|NCT00452790|EG000|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
10878542|NCT00452790|EG001|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
10879510|NCT00458302|BG000|Baseline|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
11003135|NCT01070329|FG000|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
11003136|NCT01070329|FG001|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
11003137|NCT01070329|OG000|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
11003138|NCT01070329|OG001|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
11003139|NCT01070329|EG000|Reported Event|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
11003140|NCT01070329|EG001|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
11003141|NCT01070381|BG000|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
11003142|NCT01070381|FG000|Participant Flow|Nelfilcon A / Ocufilcon D|Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
11003143|NCT01070381|FG001|Participant Flow|Ocufilcon D / Nelfilcon A|Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
11003144|NCT01070381|OG000|Outcome|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
11003145|NCT01070381|OG001|Outcome|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
11003146|NCT01070381|EG000|Reported Event|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
11003147|NCT01070381|EG001|Reported Event|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
11003148|NCT01070394|BG000|Baseline|LDX Treatment|Prospective participants will be evaluated for ADHD and study inclusion/exclusion criteria. Eligible participants will begin open-label lisdexamfetamine dimesylate for 12 weeks. Those who were able to complete all 12 weeks of the treatment were evaluated for data purposes.
11003149|NCT01070394|FG000|Participant Flow|Overall Study: Lisdexamfetamine Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
11003150|NCT01070394|OG000|Outcome|Overall Study|"Eligible participants received 12 weeks of open-label treatment. Those on treatment prior to baseline underwent a 7-day (for amphetamine or methylphenidate) or 28-day (for atomoxetine or other medications) washout period prior to initiating LDX treatment. The starting dose was 30mg/day, which could be titrated up by 20mg/day during visits 2-6 (for a maximum dose of 70mg/day). At discretion of investigator, the dose could be down-titrated by 20mg/day during visits 4-6. Once the dose was optimized (after visit 6), the dose was maintained for 8 weeks.~LDX Treatment: 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks."
11003151|NCT01070394|OG000|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
11003152|NCT01070394|OG000|Outcome|Treatment Arm|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
11003153|NCT01070394|EG000|Reported Event|LDX Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
11003154|NCT01070550|BG000|Baseline|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003155|NCT01070550|BG001|Baseline|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003156|NCT01070550|BG002|Baseline|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003157|NCT01070550|BG003|Baseline|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003158|NCT01070550|BG004|Baseline|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003159|NCT01070550|BG005|Baseline|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003160|NCT01070550|BG006|Baseline|Total|Total of all reporting groups
11003161|NCT01070550|FG000|Participant Flow|Genotype 1|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received PEGASYS® (Pegylated Interferon [PEG-IFN]) alfa-2a plus ribavirin according to the standard of care and in line with summary of product characteristics (SPCs)/local labelling were observed for up to 72 weeks.
11003162|NCT01070550|FG001|Participant Flow|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labelling were observed for up to 72 weeks.
10879511|NCT00458302|BG001|Baseline|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
11003163|NCT01070550|FG002|Participant Flow|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
11003164|NCT01070550|FG003|Participant Flow|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
11003165|NCT01070550|FG004|Participant Flow|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003166|NCT01070550|FG005|Participant Flow|Genotype Unknown|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003167|NCT01070550|OG000|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received Peginterferon (PEG-IFN) alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003168|NCT01070550|OG001|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003169|NCT01070550|OG002|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003170|NCT01070550|OG003|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003171|NCT01070550|OG004|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003172|NCT01070550|OG005|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003173|NCT01070550|OG000|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003174|NCT01070550|EG000|Reported Event|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003175|NCT01070550|EG001|Reported Event|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
10879512|NCT00458302|BG002|Baseline|Total|Total of all reporting groups
10879513|NCT00458302|FG000|Participant Flow|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
11003176|NCT01070550|EG002|Reported Event|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003177|NCT01070550|EG003|Reported Event|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003178|NCT01070550|EG004|Reported Event|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003179|NCT01070550|EG005|Reported Event|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
11003180|NCT01070693|BG000|Baseline|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
11224188|NCT02358603|FG000|Participant Flow|Case Group|At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen.
11224189|NCT02358603|FG001|Participant Flow|Control Group|Each subject of the control group will do the same test and examination with the subjects in the case group.
11003181|NCT01070693|BG001|Baseline|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
11003182|NCT01070693|BG002|Baseline|Total|Total of all reporting groups
11003183|NCT01070693|FG000|Participant Flow|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
11003184|NCT01070693|FG001|Participant Flow|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
11003185|NCT01070693|OG000|Outcome|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Prolene Hernia System: Prolene Hernia System"
11003186|NCT01070693|OG001|Outcome|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Lichtenstein technique: Lichtenstein technique"
11003187|NCT01070693|EG000|Reported Event|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Prolene Hernia System: Prolene Hernia System"
11003188|NCT01070693|EG001|Reported Event|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Lichtenstein technique: Lichtenstein technique"
11003189|NCT01070771|BG000|Baseline|Radi Pressure Wire|
11003190|NCT01070771|FG000|Participant Flow|Radi Pressure Wire|Assessment of physiological significance of coronary artery narrowings by measurement of blood flow limitation across lesion.
11003191|NCT01070771|OG000|Outcome|Radi Pressure Wire|
11003192|NCT01070771|OG000|Outcome|RADI Pressure Wire|
11003193|NCT01070771|EG000|Reported Event|RADI Pressure Wire|
11003194|NCT01070784|BG000|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
11003195|NCT01070784|BG001|Baseline|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
11003196|NCT01070784|BG002|Baseline|Total|Total of all reporting groups
11224190|NCT02358603|OG000|Outcome|Case Group|At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen.
11224191|NCT02358603|OG001|Outcome|Control Group|Each subject of the control group will do the same test and examination with the subjects in the case group.
11224192|NCT02358603|EG000|Reported Event|Case Group|At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen.
11003197|NCT01070784|FG000|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
11003198|NCT01070784|FG001|Participant Flow|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
11003199|NCT01070784|OG000|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
11003200|NCT01070784|OG001|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
11003201|NCT01070784|EG000|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
11003202|NCT01070784|EG001|Reported Event|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
11003203|NCT01070810|BG000|Baseline|Placebo|50 ml D5W D5W: Dextrose 5%
11003204|NCT01070810|BG001|Baseline|Thiamine|200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
11003205|NCT01070810|BG002|Baseline|Total|Total of all reporting groups
11003206|NCT01070810|FG000|Participant Flow|Placebo|"50 ml D5W~D5W: Dextrose 5%"
11003207|NCT01070810|FG001|Participant Flow|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
11003208|NCT01070810|OG000|Outcome|Placebo|"50 ml D5W~D5W: Dextrose 5%"
11003209|NCT01070810|OG001|Outcome|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
11003210|NCT01070810|OG000|Outcome|Thiamine Deficient Received Thiamine|Thiamine deficient (≤ 7 nmol/L) received 200mg Thiamine in 50ml D5W
11003211|NCT01070810|OG001|Outcome|Thiamine Deficient, Received Placebo|Thiamine deficient (≤ 7 nmol/L) received 50ml D5W
11003212|NCT01070810|EG000|Reported Event|Placebo|50 ml D5W D5W: Dextrose 5%
11003213|NCT01070810|EG001|Reported Event|Thiamine|200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
11003214|NCT01070888|BG000|Baseline|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
11003215|NCT01070888|BG001|Baseline|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks,"
11003216|NCT01070888|BG002|Baseline|Total|Total of all reporting groups
11003217|NCT01070888|FG000|Participant Flow|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily.~Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
11003218|NCT01070888|FG001|Participant Flow|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
11003219|NCT01070888|OG000|Outcome|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Then in the subsequent study period take budesonide/formoterol plus dummy inhaler 2 inhalations of each inhaler, twice daily~Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
11003220|NCT01070888|OG001|Outcome|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily, then in the subsequent period take budesonide and dummy inhaler 2 puffs twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
11003221|NCT01070888|EG000|Reported Event|Budesonide/Formoterol|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide/Formoterol: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
11003222|NCT01070888|EG001|Reported Event|Budesonide|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/formoterol 180mcg, 2 puffs twice daily for 2 weeks"
11003223|NCT01070979|BG000|Baseline|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
11003224|NCT01070979|BG001|Baseline|Estradiol|1 tablet daily containing 1 mg estradiol
11003225|NCT01070979|BG002|Baseline|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
11003226|NCT01070979|BG003|Baseline|Total|Total of all reporting groups
11003227|NCT01070979|FG000|Participant Flow|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
11003228|NCT01070979|FG001|Participant Flow|Estradiol|1 tablet daily containing 1 mg estradiol
11003229|NCT01070979|FG002|Participant Flow|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
11003230|NCT01070979|OG000|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
11003231|NCT01070979|OG001|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
11003232|NCT01070979|OG002|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
11003233|NCT01070979|EG000|Reported Event|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
11003234|NCT01070979|EG001|Reported Event|Estradiol|1 tablet daily containing 1 mg estradiol
11003235|NCT01070979|EG002|Reported Event|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
11003236|NCT01071044|BG000|Baseline|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.~Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
11003237|NCT01071044|BG001|Baseline|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
11003238|NCT01071044|BG002|Baseline|Total|Total of all reporting groups
11007769|NCT01092780|FG003|Participant Flow|Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg|Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
11007770|NCT01092780|OG000|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
11007771|NCT01092780|OG001|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
10845819|NCT00270296|EG002|Reported Event|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
10879514|NCT00458302|FG001|Participant Flow|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
10879515|NCT00458302|OG000|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
10845820|NCT00270634|BG000|Baseline|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
10845821|NCT00270634|BG001|Baseline|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
10845822|NCT00270634|BG002|Baseline|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
10845823|NCT00270634|BG003|Baseline|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
10845824|NCT00270634|BG004|Baseline|Total|Total of all reporting groups
10845825|NCT00270634|FG000|Participant Flow|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
10845826|NCT00270634|FG001|Participant Flow|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
10845827|NCT00270634|FG002|Participant Flow|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
10845828|NCT00270634|FG003|Participant Flow|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
10845829|NCT00270634|OG000|Outcome|High Dose Voclosporin|Starting dose of 0.8 mg/kg
10845830|NCT00270634|OG001|Outcome|Mid Dose Voclosporin|Starting dose of 0.6 mg/kg
10845831|NCT00270634|OG002|Outcome|Low Dose Voclosporin|Starting dose of 0.4 mg/kg
10845832|NCT00270634|OG003|Outcome|Tacrolimus|Standard dose
10845833|NCT00270634|OG000|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
10845834|NCT00270634|OG001|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
10845835|NCT00270634|OG002|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
10845836|NCT00270634|OG003|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
10845837|NCT00270634|EG000|Reported Event|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
10845838|NCT00270634|EG001|Reported Event|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
10845839|NCT00270634|EG002|Reported Event|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
10845840|NCT00270634|EG003|Reported Event|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
10845841|NCT00270790|BG000|Baseline|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
10845842|NCT00270790|FG000|Participant Flow|AMIFOSTINE +2 Chemo Lines +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
10845843|NCT00270790|OG000|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
10845844|NCT00270790|EG000|Reported Event|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
10845845|NCT00270842|BG000|Baseline|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
10845846|NCT00270842|BG001|Baseline|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
10845847|NCT00270842|BG002|Baseline|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
10845848|NCT00270842|BG003|Baseline|Total|Total of all reporting groups
10845849|NCT00270842|FG000|Participant Flow|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
10845850|NCT00270842|FG001|Participant Flow|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
10845851|NCT00270842|FG002|Participant Flow|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
10845852|NCT00270842|OG000|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
11224193|NCT02358603|EG001|Reported Event|Control Group|Each subject of the control group will do the same test and examination with the subjects in the case group.
11224194|NCT02358668|BG000|Baseline|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
11224195|NCT02358668|BG001|Baseline|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
11224196|NCT02358668|BG002|Baseline|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
11224197|NCT02358668|BG003|Baseline|Total|Total of all reporting groups
11224198|NCT02358668|FG000|Participant Flow|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
11224199|NCT02358668|FG001|Participant Flow|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
11003239|NCT01071044|FG000|Participant Flow|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.~Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
11003240|NCT01071044|FG001|Participant Flow|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
11003241|NCT01071044|OG000|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
11224200|NCT02358668|FG002|Participant Flow|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
10879516|NCT00458302|OG001|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
11003242|NCT01071044|OG001|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
11003243|NCT01071044|OG000|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate 30, 50, 70 mg
11003244|NCT01071044|OG001|Outcome|Control Group|"Placebo 30, 50, or 70mg"
11003245|NCT01071044|OG000|Outcome|Treatment Group|Lisdexamfetamine Dimesylate, 30, 50 or 70 mg
11003246|NCT01071044|EG000|Reported Event|Treatment Group|Lisdexamfetamine Dimesylate 30, 50, or 70 mg
11224201|NCT02358668|OG000|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
11224202|NCT02358668|OG001|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
11224203|NCT02358668|OG002|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
11224204|NCT02358668|EG000|Reported Event|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
11224205|NCT02358668|EG001|Reported Event|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
11224206|NCT02358668|EG002|Reported Event|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
11224207|NCT02358863|BG000|Baseline|Chemotherapy|"Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel~Modified FOLFOX6: Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1~Docetaxel/Capecitabine: Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14~Cisplatin/Irinotecan: Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days~Cisplatin/Docetaxel: Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1~IRI/EPI: Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days~EPI/Docetaxel: Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2~Irinotecan/Docetaxel: Irinote"
11224502|NCT02360397|EG000|Reported Event|Ranolazine|"Ranolazine 1000 mg tablet twice daily for 30 days~ranolazine: Ranolazine 1000 mg tablet twice daily for 30 days"
10879517|NCT00458302|EG000|Reported Event|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
11003247|NCT01071044|EG001|Reported Event|Control Group|"Placebo 30, 50 or 70 mg"
11007772|NCT01092780|OG002|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
11003248|NCT01071070|BG000|Baseline|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
11224208|NCT02358863|FG000|Participant Flow|Chemotherapy|"Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel~Modified FOLFOX6: Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1~Docetaxel/Capecitabine: Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14~Cisplatin/Irinotecan: Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days~Cisplatin/Docetaxel: Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1~IRI/EPI: Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days~EPI/Docetaxel: Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2~Irinotecan/Docetaxel: Irinote"
11224209|NCT02358863|OG000|Outcome|Chemotherapy|"Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel~Modified FOLFOX6: Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1~Docetaxel/Capecitabine: Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14~Cisplatin/Irinotecan: Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days~Cisplatin/Docetaxel: Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1~IRI/EPI: Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days~EPI/Docetaxel: Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2~Irinotecan/Docetaxel: Irinote"
11224210|NCT02358863|EG000|Reported Event|Chemotherapy|"Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel~Modified FOLFOX6: Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1~Docetaxel/Capecitabine: Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14~Cisplatin/Irinotecan: Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days~Cisplatin/Docetaxel: Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1~IRI/EPI: Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days~EPI/Docetaxel: Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2~Irinotecan/Docetaxel: Irinote"
11224211|NCT02358876|BG000|Baseline|Participants|
11224212|NCT02358876|FG000|Participant Flow|Participants|
11224213|NCT02358876|OG000|Outcome|Participants|
11224214|NCT02358876|EG000|Reported Event|Participants|
11224215|NCT02358889|BG000|Baseline|hI-con1|"Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~hI-con1: Intravitreal injection of hI-con1 0.3 mg~Sham injection: No injection is given, a needleless syringe is used to mimic an injection."
11224216|NCT02358889|BG001|Baseline|hI-con1 + Ranibizumab|"Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~hI-con1: Intravitreal injection of hI-con1 0.3 mg~ranibizumab: Intravitreal injection of ranibizumab 0.5 mg"
11224217|NCT02358889|BG002|Baseline|Ranibizumab|"Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~ranibizumab: Intravitreal injection of ranibizumab 0.5 mg~Sham injection: No injection is given, a needleless syringe is used to mimic an injection."
11224218|NCT02358889|BG003|Baseline|Total|Total of all reporting groups
11224219|NCT02358889|FG000|Participant Flow|hI-con1|"Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~hI-con1: Intravitreal injection of hI-con1 0.3 mg~Sham injection: No injection is given, a needleless syringe is used to mimic an injection."
11224220|NCT02358889|FG001|Participant Flow|hI-con1 + Ranibizumab|"Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~hI-con1: Intravitreal injection of hI-con1 0.3 mg~ranibizumab: Intravitreal injection of ranibizumab 0.5 mg"
11224221|NCT02358889|FG002|Participant Flow|Ranibizumab|"Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~ranibizumab: Intravitreal injection of ranibizumab 0.5 mg~Sham injection: No injection is given, a needleless syringe is used to mimic an injection."
11224222|NCT02358889|OG000|Outcome|hI-con1|"Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~hI-con1: Intravitreal injection of hI-con1 0.3 mg~Sham injection: No injection is given, a needleless syringe is used to mimic an injection."
10879518|NCT00458302|EG001|Reported Event|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
10879519|NCT00458302|EG002|Reported Event|Total|
11003249|NCT01071070|BG001|Baseline|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
11003250|NCT01071070|BG002|Baseline|Total|Total of all reporting groups
11003251|NCT01071070|FG000|Participant Flow|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
11003252|NCT01071070|FG001|Participant Flow|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
11003253|NCT01071070|OG000|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
11003254|NCT01071070|OG001|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
11003255|NCT01071070|EG000|Reported Event|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
11003256|NCT01071070|EG001|Reported Event|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
11224223|NCT02358889|OG001|Outcome|hI-con1 + Ranibizumab|"Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~hI-con1: Intravitreal injection of hI-con1 0.3 mg~ranibizumab: Intravitreal injection of ranibizumab 0.5 mg"
11224224|NCT02358889|OG002|Outcome|Ranibizumab|"Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~ranibizumab: Intravitreal injection of ranibizumab 0.5 mg~Sham injection: No injection is given, a needleless syringe is used to mimic an injection."
11224225|NCT02358889|EG000|Reported Event|hI-con1|"Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~hI-con1: Intravitreal injection of hI-con1 0.3 mg~Sham injection: No injection is given, a needleless syringe is used to mimic an injection."
11224226|NCT02358889|EG001|Reported Event|hI-con1 + Ranibizumab|"Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~hI-con1: Intravitreal injection of hI-con1 0.3 mg~ranibizumab: Intravitreal injection of ranibizumab 0.5 mg"
11224227|NCT02358889|EG002|Reported Event|Ranibizumab|"Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.~ranibizumab: Intravitreal injection of ranibizumab 0.5 mg~Sham injection: No injection is given, a needleless syringe is used to mimic an injection."
11224228|NCT02359006|BG000|Baseline|Minocycline|"200mg minocycline~Minocycline: Minocycline will be compared with placebo"
11224229|NCT02359006|BG001|Baseline|Placebo|"Sugar pill~Placebo: Placebo will be compared with minocycline"
11224230|NCT02359006|BG002|Baseline|Total|Total of all reporting groups
11003257|NCT01071083|BG000|Baseline|Natalizumab|300 mg intravenous every 4 weeks
11003258|NCT01071083|BG001|Baseline|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
11003259|NCT01071083|BG002|Baseline|Interferon β-1a|30 ug intramuscular once per week
11003260|NCT01071083|BG003|Baseline|Glatiramer Acetate|20 mg subcutaneous once daily
11003261|NCT01071083|BG004|Baseline|Methylprednisolone|1000 mg intravenous every 4 weeks
11003262|NCT01071083|BG005|Baseline|Total|Total of all reporting groups
11003263|NCT01071083|FG000|Participant Flow|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
11224231|NCT02359006|FG000|Participant Flow|Minocycline|"200mg minocycline~Minocycline: Minocycline will be compared with placebo"
11224232|NCT02359006|FG001|Participant Flow|Placebo|"Sugar pill~Placebo: Placebo will be compared with minocycline"
11003264|NCT01071083|FG001|Participant Flow|Natalizumab|300 mg intravenous every 4 weeks
11003265|NCT01071083|FG002|Participant Flow|Interferon β-1a|30 ug intramuscular once per week
11003266|NCT01071083|FG003|Participant Flow|Glatiramer Acetate|20 mg subcutaneous once daily
11003267|NCT01071083|FG004|Participant Flow|Methylprednisolone|1000 mg intravenous every 4 weeks
11003268|NCT01071083|OG000|Outcome|Natalizumab|300 mg intravenous every 4 weeks
11003269|NCT01071083|OG001|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
11003270|NCT01071083|OG002|Outcome|Interferon β-1a|30 ug intramuscular once per week
11003271|NCT01071083|OG003|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
11003272|NCT01071083|OG004|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
11003273|NCT01071083|EG000|Reported Event|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
11003274|NCT01071083|EG001|Reported Event|Natalizumab|300 mg intravenous every 4 weeks
11003275|NCT01071083|EG002|Reported Event|Interferon β-1a|30 ug intramuscular once per week
11003276|NCT01071083|EG003|Reported Event|Glatiramer Acetate|20 mg subcutaneous once daily
11003277|NCT01071083|EG004|Reported Event|Methylprednisolone|1000 mg intravenous every 4 weeks
11003278|NCT01071096|BG000|Baseline|Enrolled Participants|Enrolled Participants includes subjects in both Group A (treated with BOTOX and Visit 1 and Placebo at Visit 5) and Group B (treated with Placebo at Visit 1 and BOTOX at Visit 5).
11224233|NCT02359006|OG000|Outcome|Minocycline|This group received 200mg minocycline 1x/day for 15 days.
11224234|NCT02359006|OG001|Outcome|Placebo|This group received a placebo capsule 1x/day for 15 days.
11224235|NCT02359006|OG001|Outcome|Placebo|This group received placebo 1x/day for 15 days.
11224236|NCT02359006|OG001|Outcome|Placebo|This group received placebo capsules 1x/day for 15 days.
11224237|NCT02359006|EG000|Reported Event|Minocycline|"200mg minocycline~Minocycline: Minocycline will be compared with placebo"
11224238|NCT02359006|EG001|Reported Event|Placebo|"Sugar pill~Placebo: Placebo will be compared with minocycline"
11224239|NCT02359019|BG000|Baseline|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11224240|NCT02359019|FG000|Participant Flow|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11003279|NCT01071096|FG000|Participant Flow|Group A|Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
10878543|NCT00452790|EG002|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
10878544|NCT00452790|EG003|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
10878545|NCT00452790|EG004|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 12 months of age (toddler dose).
10878546|NCT00452790|EG005|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 12 months of age (toddler dose).
10878547|NCT00452868|BG000|Baseline|Donepezil|
10878548|NCT00452868|FG000|Participant Flow|Donepezil|Patients less than 35 kilograms(kg): Donepezil 5 milligrams (mg) orally once every alternate day. Patients greater than 35 kg Donepezil 5 mg orally once per day. If there are no adverse effects noted on review of symptoms, the dose will be increased to 5 mg daily for patients < 35 kg. And to 10 mg/day for patients > 35 kg. This evaluation and dose escalation may be done as early as week 4. For all, donepezil will be administered 24 weeks.
10878549|NCT00452868|OG000|Outcome|Donepezil|
10878550|NCT00452868|EG000|Reported Event|Donepezil|
10878551|NCT00453102|BG000|Baseline|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
10878552|NCT00453102|FG000|Participant Flow|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
10878553|NCT00453102|OG000|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
10878554|NCT00453102|EG000|Reported Event|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
10878555|NCT00453154|BG000|Baseline|Phase I|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
10878556|NCT00453154|BG001|Baseline|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
10878557|NCT00453154|BG002|Baseline|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
10878558|NCT00453154|BG003|Baseline|Total|Total of all reporting groups
10878559|NCT00453154|FG000|Participant Flow|Phase 1B|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
10878560|NCT00453154|FG001|Participant Flow|Phase II Combination Chemotherapy|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IVover 1 hour on days 1, 2, and 3 every cycle"
11003280|NCT01071096|FG001|Participant Flow|Group B|Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
11224241|NCT02359019|OG000|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11224242|NCT02359019|EG000|Reported Event|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11224243|NCT02359045|BG000|Baseline|Part 1|"Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions.~A- D1400147, B- D14000136, C- D14000137 & D- Epanova."
11224244|NCT02359045|BG001|Baseline|Part 2|"Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions.~A-D1400147, B- D14000136 or D14000137 & C- Epanova."
11224245|NCT02359045|BG002|Baseline|Total|Total of all reporting groups
11224246|NCT02359045|FG000|Participant Flow|Part 1|"Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions.~A- D1400147, B- D14000136, C- D14000137 & D- Epanova."
11224247|NCT02359045|FG001|Participant Flow|Part 2|"Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions.~A-D1400147, B- D14000136 or D14000137 & C- Epanova."
11224248|NCT02359045|OG000|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
11224249|NCT02359045|OG001|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
11224250|NCT02359045|OG002|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
11224251|NCT02359045|OG003|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
11224252|NCT02359045|OG004|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
11224253|NCT02359045|OG005|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
10878561|NCT00453154|FG002|Participant Flow|Double Blind Placebo Maintenance With Optional Crossover|"Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.~At progression, participants receiving placebo could cross over to receive open label sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
10878562|NCT00453154|FG003|Participant Flow|Double Blind Sunitinib Maintenance|Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
10878563|NCT00453154|OG000|Outcome|Cohort 1|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
11007773|NCT01092780|OG003|Outcome|Placebo|Participants received single doses of Placebo.
11224254|NCT02359045|OG006|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
11224255|NCT02359045|EG000|Reported Event|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
11224256|NCT02359045|EG001|Reported Event|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
11224257|NCT02359045|EG002|Reported Event|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
11224258|NCT02359045|EG003|Reported Event|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
11224259|NCT02359045|EG004|Reported Event|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
11224260|NCT02359045|EG005|Reported Event|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
11224261|NCT02359045|EG006|Reported Event|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
11224262|NCT02359058|BG000|Baseline|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11003281|NCT01071096|OG000|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
11003282|NCT01071096|OG001|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
11003283|NCT01071096|OG000|Outcome|OnabotulinumtoxinA|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7).
11003284|NCT01071096|OG001|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
11003285|NCT01071096|OG000|Outcome|OnabotulinumtoxinA Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with >30% reduction in number of headache days per month when compared to Baseline
11003286|NCT01071096|OG001|Outcome|OnabotulinumtoxinA Non-Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with <30% reduction in number of headache days per month when compared to Baseline
11003287|NCT01071096|OG002|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
11003288|NCT01071096|OG000|Outcome|Month 1 vs. Saline Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
11003289|NCT01071096|OG001|Outcome|Month 1 vs. Saline Non-Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
11003290|NCT01071096|OG002|Outcome|Month 3 vs. Saline Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
11003291|NCT01071096|OG003|Outcome|Month 3 vs. Saline Non-Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
11003292|NCT01071096|OG004|Outcome|Month 1 vs. Month 3 Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with >30% reduction in number of headache days per month from baseline.
11003293|NCT01071096|OG005|Outcome|Month 1 vs. Month 3 Non-Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with <30% reduction in number of headache days per month from baseline.
11003294|NCT01071096|EG000|Reported Event|Saline|Subjects injected with Saline in Group A at Visit 5 (Day 151) and Group B at Visit 1 (Day 1)
11003295|NCT01071096|EG001|Reported Event|OnabotulinumtoxinA|Subjects injected with onabotulinumtoxinA in Group A at Visit 1 (Day 1) and Group B at Visit 5 (Day 151)
11003296|NCT01071200|BG000|Baseline|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
11003297|NCT01071200|BG001|Baseline|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator's discretion till r-hCG administration day.
11003298|NCT01071200|BG002|Baseline|Total|Total of all reporting groups
11336504|NCT03567291|BG000|Baseline|All Participants|All participants underwent TEV-50717 dose titration in this study. They received 6 mg of TEV-50717 with food on the evening of day 1. The titration scheme and maximum dose were determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study.
11003299|NCT01071200|FG000|Participant Flow|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
11003300|NCT01071200|FG001|Participant Flow|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator's discretion till r-hCG administration day.
11003301|NCT01071200|OG000|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
11003302|NCT01071200|OG001|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
11003303|NCT01071200|EG000|Reported Event|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
11003304|NCT01071200|EG001|Reported Event|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
11003305|NCT01071252|BG000|Baseline|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
11003306|NCT01071252|BG001|Baseline|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003307|NCT01071252|BG002|Baseline|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003308|NCT01071252|BG003|Baseline|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003309|NCT01071252|BG004|Baseline|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003310|NCT01071252|BG005|Baseline|Total|Total of all reporting groups
11003311|NCT01071252|FG000|Participant Flow|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
11003312|NCT01071252|FG001|Participant Flow|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003313|NCT01071252|FG002|Participant Flow|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11224263|NCT02359058|BG001|Baseline|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11224264|NCT02359058|BG002|Baseline|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11224265|NCT02359058|BG003|Baseline|Total|Total of all reporting groups
11224266|NCT02359058|FG000|Participant Flow|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11224267|NCT02359058|FG001|Participant Flow|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11224268|NCT02359058|FG002|Participant Flow|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11224269|NCT02359058|OG000|Outcome|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11224270|NCT02359058|OG001|Outcome|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11224271|NCT02359058|OG002|Outcome|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11224272|NCT02359058|OG003|Outcome|Total|Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin and Ramucirumab + S-1 + Oxaliplatin.
11224273|NCT02359058|EG000|Reported Event|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11224274|NCT02359058|EG001|Reported Event|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11224275|NCT02359058|EG002|Reported Event|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11224276|NCT02359110|BG000|Baseline|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
11224277|NCT02359110|BG001|Baseline|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
10878564|NCT00453154|OG001|Outcome|Cohort 2|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 37.5 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
11224278|NCT02359110|BG002|Baseline|Total|Total of all reporting groups
11224279|NCT02359110|FG000|Participant Flow|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
11224280|NCT02359110|FG001|Participant Flow|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
11224281|NCT02359110|OG000|Outcome|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
11224282|NCT02359110|OG001|Outcome|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
11224283|NCT02359110|EG000|Reported Event|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
11003314|NCT01071252|FG003|Participant Flow|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003315|NCT01071252|FG004|Participant Flow|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003316|NCT01071252|OG000|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
11224284|NCT02359110|EG001|Reported Event|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
11224285|NCT02359305|BG000|Baseline|IV Acetaminophen|Acetaminophen administered by intravenous infusion.
11224286|NCT02359305|BG001|Baseline|Rectal Acetaminophen|Acetaminophen administered by rectal suppository.
11224287|NCT02359305|BG002|Baseline|Total|Total of all reporting groups
11224288|NCT02359305|FG000|Participant Flow|IV Acetaminophen|Acetaminophen given by intravenous infusion.
11224289|NCT02359305|FG001|Participant Flow|Rectal Acetaminophen|Acetaminophen given by rectal suppository.
11224290|NCT02359305|OG000|Outcome|IV Acetaminophen|Acetaminophen administered by intravenous infusion.
11224291|NCT02359305|OG001|Outcome|Rectal Acetaminophen|Acetaminophen administered by rectal suppository.
11224292|NCT02359305|EG000|Reported Event|IV Acetaminophen|Acetaminophen administered by intravenous infusion.
11224293|NCT02359305|EG001|Reported Event|Rectal Acetaminophen|Acetaminophen administered by rectal suppository.
11224294|NCT02359435|BG000|Baseline|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
11224295|NCT02359435|BG001|Baseline|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
11224296|NCT02359435|BG002|Baseline|Total|Total of all reporting groups
11224297|NCT02359435|FG000|Participant Flow|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
11224298|NCT02359435|FG001|Participant Flow|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
11224299|NCT02359435|OG000|Outcome|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
11224300|NCT02359435|OG001|Outcome|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
11224301|NCT02359435|EG000|Reported Event|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
11003317|NCT01071252|OG001|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11224302|NCT02359435|EG001|Reported Event|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
11224303|NCT02359552|BG000|Baseline|Placebo|"Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).~Placebo"
11224304|NCT02359552|BG001|Baseline|Rasagiline|"Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).~Rasagiline"
11224305|NCT02359552|BG002|Baseline|Total|Total of all reporting groups
10845853|NCT00270842|OG001|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
10845854|NCT00270842|OG002|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
10845855|NCT00270842|EG000|Reported Event|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
10845856|NCT00270842|EG001|Reported Event|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
10845857|NCT00270842|EG002|Reported Event|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
10845858|NCT00270855|BG000|Baseline|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
10845859|NCT00270855|BG001|Baseline|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
10845860|NCT00270855|BG002|Baseline|Total|Total of all reporting groups
10845861|NCT00270855|FG000|Participant Flow|Arm Crank Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
10845862|NCT00270855|FG001|Participant Flow|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
10845863|NCT00270855|OG000|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
11003318|NCT01071252|OG002|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003319|NCT01071252|OG003|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003320|NCT01071252|OG004|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003321|NCT01071252|EG000|Reported Event|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
11003322|NCT01071252|EG001|Reported Event|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003323|NCT01071252|EG002|Reported Event|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11224306|NCT02359552|FG000|Participant Flow|Placebo|"Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).~Placebo"
11224307|NCT02359552|FG001|Participant Flow|Rasagiline|"Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).~Rasagiline"
11003324|NCT01071252|EG003|Reported Event|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
11003325|NCT01071252|EG004|Reported Event|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
10845864|NCT00270855|OG001|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
11003326|NCT01071278|BG000|Baseline|Intent-to-Treat Population|Baseline characteristics were reported for the 2359 participants in the Intent-to-Treat (ITT) Population, which included all participants from the Evaluable Population who began therapy at or after Visit 1. The ITT Population excluded 31 of the 2390 evaluable participants who began treatment prior to Visit 1.
11003327|NCT01071278|FG000|Participant Flow|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
11003328|NCT01071278|OG000|Outcome|Patients Treated Within a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
11003329|NCT01071278|OG001|Outcome|Patients Treated Outside a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
11003330|NCT01071278|OG000|Outcome|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
11003331|NCT01071278|EG000|Reported Event|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
11003332|NCT01071317|BG000|Baseline|Comprehensive Care|"Reinforcement of diagnosis, education, medications, and referral~Naproxen: Naproxen 500mg PO bid prn headache~Sumatriptan: 100mg po q day prn headache~Migraine education: Educational program available through NIH/ national library of medicine/ X-plain~Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria"
11003333|NCT01071317|BG001|Baseline|Typical Care|"Usual care~Typical care: Care to be determined by attending physician"
11003334|NCT01071317|BG002|Baseline|Total|Total of all reporting groups
11003335|NCT01071317|FG000|Participant Flow|Comprehensive Care|"Reinforcement of diagnosis, education, medications, and referral~Naproxen: Naproxen 500mg PO bid prn headache~Sumatriptan: 100mg po q day prn headache~Migraine education: Educational program available through NIH/ national library of medicine/ X-plain~Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria"
11003336|NCT01071317|FG001|Participant Flow|Typical Care|"Usual care~Typical care: Care to be determined by attending physician"
11003337|NCT01071317|OG000|Outcome|Comprehensive Care|"Reinforcement of diagnosis, education, medications, and referral~Naproxen: Naproxen 500mg PO bid prn headache~Sumatriptan: 100mg po q day prn headache~Migraine education: Educational program available through NIH/ national library of medicine/ X-plain~Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria"
11003338|NCT01071317|OG001|Outcome|Typical Care|"Usual care~Typical care: Care to be determined by attending physician"
11003339|NCT01071317|EG000|Reported Event|Comprehensive Care|"Reinforcement of diagnosis, education, medications, and referral~Naproxen: Naproxen 500mg PO bid prn headache~Sumatriptan: 100mg po q day prn headache~Migraine education: Educational program available through HIH/ national library of medicine/ X-plain~Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria"
11003340|NCT01071317|EG001|Reported Event|Typical Care|"Usual care~Typical care: Care to be determined by attending physician"
11007774|NCT01092780|EG000|Reported Event|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
11224308|NCT02359552|OG000|Outcome|Placebo|"Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).~Placebo"
11224309|NCT02359552|OG001|Outcome|Rasagiline|"Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).~Rasagiline"
11224310|NCT02359552|EG000|Reported Event|Placebo|"Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).~Placebo"
11224311|NCT02359552|EG001|Reported Event|Rasagiline|"Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).~Rasagiline"
11224312|NCT02359851|BG000|Baseline|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10878565|NCT00453154|OG002|Outcome|Cohort 3|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 50 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
10878566|NCT00453154|OG000|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
10878567|NCT00453154|OG001|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
10878568|NCT00453154|EG000|Reported Event|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
10878569|NCT00453154|EG001|Reported Event|Arm II (Combination Chemotherapy + Placebo Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
10878570|NCT00453180|BG000|Baseline|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
10878571|NCT00453180|BG001|Baseline|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
10878572|NCT00453180|BG002|Baseline|Total|Total of all reporting groups
10878573|NCT00453180|FG000|Participant Flow|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
10878574|NCT00453180|FG001|Participant Flow|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
10878575|NCT00453180|OG000|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
10878576|NCT00453180|OG001|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
10878577|NCT00453180|EG000|Reported Event|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
10878578|NCT00453180|EG001|Reported Event|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain in active ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
10878579|NCT00453193|BG000|Baseline|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
10878580|NCT00453193|FG000|Participant Flow|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
11224313|NCT02359851|FG000|Participant Flow|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11224314|NCT02359851|OG000|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11003341|NCT01071356|BG000|Baseline|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
11003342|NCT01071356|BG001|Baseline|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
11003343|NCT01071356|BG002|Baseline|Total|Total of all reporting groups
11003344|NCT01071356|FG000|Participant Flow|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
11003345|NCT01071356|FG001|Participant Flow|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
11003346|NCT01071356|OG000|Outcome|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
11003347|NCT01071356|OG001|Outcome|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
11003348|NCT01071356|EG000|Reported Event|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
11003349|NCT01071356|EG001|Reported Event|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
11003350|NCT01071395|BG000|Baseline|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
10845865|NCT00270855|OG000|Outcome|Arm Crank Ergometer|"Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
10878581|NCT00453193|OG000|Outcome|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
11003351|NCT01071395|BG001|Baseline|Placebo|Placebo: Sugar pill given 3 times daily
11003352|NCT01071395|BG002|Baseline|Total|Total of all reporting groups
11003353|NCT01071395|FG000|Participant Flow|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
11003354|NCT01071395|FG001|Participant Flow|Placebo|Placebo: Sugar pill given 3 times daily
11003355|NCT01071395|OG000|Outcome|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
11003356|NCT01071395|OG001|Outcome|Placebo|Placebo: Sugar pill given daily in three divided doses
11003357|NCT01071395|EG000|Reported Event|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
11003358|NCT01071395|EG001|Reported Event|Placebo|Placebo: Sugar pill given 3 times daily
11003359|NCT01071512|BG000|Baseline|Tysabri|Natalizumab 300 mg IV every 4 weeks
11003360|NCT01071512|FG000|Participant Flow|Tysabri|Natalizumab 300 mg IV every 4 weeks
11003361|NCT01071512|OG000|Outcome|Tysabri|Natalizumab 300 mg IV every 4 weeks
11003362|NCT01071512|EG000|Reported Event|Tysabri|Natalizumab 300 mg IV every 4 weeks
11003363|NCT01071538|BG000|Baseline|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
11003364|NCT01071538|FG000|Participant Flow|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
11003365|NCT01071538|OG000|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
11003366|NCT01071538|EG000|Reported Event|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
11003367|NCT01071798|BG000|Baseline|Main Analysis Set|Participants who received at least one cycle of rituximab
11003368|NCT01071798|FG000|Participant Flow|Main Analysis Set|Participants who received at least one cycle of rituximab
11003369|NCT01071798|OG000|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
11003370|NCT01071798|OG001|Outcome|Seronegative Participants|Subgroup of seronegative participants
11003371|NCT01071798|OG002|Outcome|Seropositive Participants|Subgroup of seropositive participants
11003372|NCT01071798|OG000|Outcome|Cycle 1|During Cycle 1 - Main Analysis Set
11003373|NCT01071798|OG001|Outcome|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
11003374|NCT01071798|OG002|Outcome|Total|During the Trial - All Participants
11003375|NCT01071798|OG000|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
11003376|NCT01071798|OG001|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
11003377|NCT01071798|OG002|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
11003378|NCT01071798|EG000|Reported Event|Cycle 1|During Cycle 1 - Main Analysis Set
11003379|NCT01071798|EG001|Reported Event|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
11003380|NCT01071798|EG002|Reported Event|Total|During the entire trial
11003381|NCT01071915|BG000|Baseline|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
11003382|NCT01071915|FG000|Participant Flow|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
11003383|NCT01071915|OG000|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
11003384|NCT01071915|EG000|Reported Event|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
11003385|NCT01071954|BG000|Baseline|Overall Study|
11003386|NCT01071954|FG000|Participant Flow|Romiplostim|Participants received romiplostim administered by subcutaneous injection once a week. The starting dose of romiplostim was 1 μg/kg; weekly dose increases continued in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg in an attempt to reach a target platelet count of between 50 x 10^9/L and 200 x 10^9/L.
11003387|NCT01071954|OG000|Outcome|Romiplostim|Participants received romiplostim administered by subcutaneous injection once a week. The starting dose of romiplostim was 1 μg/kg; weekly dose increases continued in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg in an attempt to reach a target platelet count of between 50 x 10^9/L and 200 x 10^9/L.
11003388|NCT01071954|EG000|Reported Event|Romiplostim|Participants received romiplostim administered by subcutaneous injection once a week. The starting dose of romiplostim was 1 μg/kg; weekly dose increases continued in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg in an attempt to reach a target platelet count of between 50 x 10^9/L and 200 x 10^9/L.
11003389|NCT01072006|BG000|Baseline|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
11003390|NCT01072006|BG001|Baseline|PTSD Group|PTSD (not TBI)
11003391|NCT01072006|BG002|Baseline|TBI Group|TBI (no PTSD)
11003392|NCT01072006|BG003|Baseline|TBI+PTSD Group|Combined TBI history and PTSD
11003393|NCT01072006|BG004|Baseline|Total|Total of all reporting groups
11003394|NCT01072006|FG000|Participant Flow|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
11003395|NCT01072006|FG001|Participant Flow|PTSD Group|PTSD (not TBI)
11003396|NCT01072006|FG002|Participant Flow|TBI Group|TBI (no PTSD)
11003397|NCT01072006|FG003|Participant Flow|TBI+PTSD Group|Combined TBI history and PTSD
11003398|NCT01072006|OG000|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
11003399|NCT01072006|OG001|Outcome|PTSD Group|PTSD (not TBI)
11003400|NCT01072006|OG002|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
11003401|NCT01072006|OG002|Outcome|TBI Group|TBI (no PTSD)
11003402|NCT01072006|OG003|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
11003403|NCT01072006|EG000|Reported Event|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
11003404|NCT01072006|EG001|Reported Event|PTSD Group|PTSD (not TBI)
11003405|NCT01072006|EG002|Reported Event|TBI Group|TBI (no PTSD)
11003406|NCT01072006|EG003|Reported Event|TBI+PTSD Group|Combined TBI history and PTSD
11003407|NCT01072032|BG000|Baseline|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
11003408|NCT01072032|BG001|Baseline|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
11003409|NCT01072032|BG002|Baseline|Total|Total of all reporting groups
11003410|NCT01072032|FG000|Participant Flow|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
11003411|NCT01072032|FG001|Participant Flow|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
11003412|NCT01072032|OG000|Outcome|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team."
11003413|NCT01072032|OG001|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
11003414|NCT01072032|OG000|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
11003415|NCT01072032|EG000|Reported Event|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
11003416|NCT01072032|EG001|Reported Event|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
11003417|NCT01072136|BG000|Baseline|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
11003418|NCT01072136|BG001|Baseline|Placebo|Placebo
11003419|NCT01072136|BG002|Baseline|Total|Total of all reporting groups
11003420|NCT01072136|FG000|Participant Flow|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
11003421|NCT01072136|FG001|Participant Flow|Placebo|Placebo
11003422|NCT01072136|OG000|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
11003423|NCT01072136|OG001|Outcome|Placebo|Placebo
11003424|NCT01072136|OG000|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
11003425|NCT01072136|OG001|Outcome|Partial Response|Partial response for mucopurulent cervicitis
10845866|NCT00270855|OG001|Outcome|FESLCE|"Functional Electrical Stimulation Leg Cycle Ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
10845867|NCT00270855|EG000|Reported Event|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
11003426|NCT01072136|OG002|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
11003427|NCT01072136|EG000|Reported Event|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
11003428|NCT01072136|EG001|Reported Event|Placebo|Placebo
11003429|NCT01072149|BG000|Baseline|Entire Study Population|All participants who self-administered placebo, FF/VI 50/25 µg, FF/VI 100/25 µg, or FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI in any of the three 28-day treatment periods.
11003430|NCT01072149|FG000|Participant Flow|Sequence 1: FF/VI 50/25 µg, Placebo, FF/VI 100/25 µg|Participants self-administered fluticasone furoate/vilanterol (FF/VI) 50/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003431|NCT01072149|FG001|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003432|NCT01072149|FG002|Participant Flow|Sequence 3: FF/VI 200/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003433|NCT01072149|FG003|Participant Flow|Sequence 4: FF/VI 200/25 µg, Placebo, and FF/VI 100/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003434|NCT01072149|FG004|Participant Flow|Sequence 5: FF/VI 50/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003435|NCT01072149|FG005|Participant Flow|Sequence 6: FF/VI 50/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003436|NCT01072149|FG006|Participant Flow|Sequence 7: FF/VI 200/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003437|NCT01072149|FG007|Participant Flow|Sequence 8: Placebo, FF/VI 50/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003438|NCT01072149|FG008|Participant Flow|Sequence 9: FF/VI 100/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11007775|NCT01092780|EG001|Reported Event|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
11007776|NCT01092780|EG002|Reported Event|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
11007777|NCT01092780|EG003|Reported Event|Placebo|Participants received single doses of Placebo.
11003439|NCT01072149|FG009|Participant Flow|Sequence 10: FF/VI 100/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003440|NCT01072149|FG010|Participant Flow|Sequence 11: Placebo, FF/VI 200/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003441|NCT01072149|FG011|Participant Flow|Sequence 12: Placebo, FF/VI 200/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003442|NCT01072149|FG012|Participant Flow|Sequence 13: Placebo, FF/VI 100/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003443|NCT01072149|FG013|Participant Flow|Sequence 14: FF/VI 200/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003444|NCT01072149|FG014|Participant Flow|Sequence 15: FF/VI 100/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003445|NCT01072149|FG015|Participant Flow|Sequence 16: Placebo, FF/VI 50/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003446|NCT01072149|FG016|Participant Flow|Sequence 17: FF/VI 50/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 50/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003447|NCT01072149|FG017|Participant Flow|Sequence 18: FF/VI 100/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
11003448|NCT01072149|OG000|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
11003449|NCT01072149|OG001|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
11003450|NCT01072149|OG002|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
11003451|NCT01072149|OG003|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
11003452|NCT01072149|EG000|Reported Event|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
11003453|NCT01072149|EG001|Reported Event|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
11003454|NCT01072149|EG002|Reported Event|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
11003455|NCT01072149|EG003|Reported Event|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
11003456|NCT01072188|BG000|Baseline|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
11003457|NCT01072188|BG001|Baseline|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
11003458|NCT01072188|BG002|Baseline|Total|Total of all reporting groups
11003459|NCT01072188|FG000|Participant Flow|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
11003460|NCT01072188|FG001|Participant Flow|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
11003461|NCT01072188|OG000|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
11003462|NCT01072188|OG001|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
11003463|NCT01072188|EG000|Reported Event|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
11003464|NCT01072188|EG001|Reported Event|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
11003465|NCT01072201|BG000|Baseline|Total Toothpaste|Triclosan/copolymer/Fluoride
11003466|NCT01072201|BG001|Baseline|Ultrabrite Toothpaste|sodium fluoride control (placebo)
11003467|NCT01072201|BG002|Baseline|Total|Total of all reporting groups
11003468|NCT01072201|FG000|Participant Flow|Total Toothpaste|Triclosan/copolymer/Fluoride
11003469|NCT01072201|FG001|Participant Flow|Ultrabrite Toothpaste|sodium fluoride control(placebo)
11003470|NCT01072201|OG000|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
11003471|NCT01072201|OG001|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
11003472|NCT01072201|EG000|Reported Event|Total Toothpaste|Triclosan/copolymer/Fluoride
11224315|NCT02359851|EG000|Reported Event|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11224316|NCT02359877|BG000|Baseline|BCD-054 (Single Doses)|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC
11224317|NCT02359877|BG001|Baseline|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
11224318|NCT02359877|BG002|Baseline|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
10845868|NCT00270855|EG001|Reported Event|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
10845869|NCT00270894|BG000|Baseline|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
10845870|NCT00270894|FG000|Participant Flow|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
10845871|NCT00270894|OG000|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
10845872|NCT00270894|EG000|Reported Event|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
10845873|NCT00270998|BG000|Baseline|Pessary|Intravaginal pessary
11224319|NCT02359877|BG003|Baseline|BCD-054 (Multiple Doses)|Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
10845874|NCT00270998|BG001|Baseline|Behavioral Therapy|Pelvic muscle training and exercises
11224320|NCT02359877|BG004|Baseline|Total|Total of all reporting groups
10845875|NCT00270998|BG002|Baseline|Combination of Pessary and Behavioral Therapy|Treatment includes a combination of both pessary and pelvic muscle exercises
10845876|NCT00270998|BG003|Baseline|Total|Total of all reporting groups
10845877|NCT00270998|FG000|Participant Flow|Pessary|Intravaginal incontinence pessary
10845878|NCT00270998|FG001|Participant Flow|Behavioral Therapy|Pelvic muscle training and exercises
10845879|NCT00270998|FG002|Participant Flow|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
10845880|NCT00270998|OG000|Outcome|Pessary|Intravaginal pessary
10845881|NCT00270998|OG001|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
11224321|NCT02359877|FG000|Participant Flow|BCD-054 (Single Doses)|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC
11224322|NCT02359877|FG001|Participant Flow|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
11224323|NCT02359877|FG002|Participant Flow|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
11224324|NCT02359877|FG003|Participant Flow|BCD-054 (Multiple Dose)|Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
11224325|NCT02359877|OG000|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
11224326|NCT02359877|OG001|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
11224327|NCT02359877|OG002|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
11224328|NCT02359877|OG003|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
11224329|NCT02359877|OG004|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
11224330|NCT02359877|OG005|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
11224331|NCT02359877|OG006|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
10845882|NCT00270998|OG002|Outcome|Combination of Pessary and Behavioral Therapy|Treatment includes a combination of both pessary and pelvic muscle exercises
10845883|NCT00270998|OG000|Outcome|Pessary|Intravaginal incontinence pessary
10845884|NCT00270998|OG002|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
10845885|NCT00270998|EG000|Reported Event|Pessary|Intravaginal incontinence pessary
10845886|NCT00270998|EG001|Reported Event|Behavioral Therapy|Pelvic muscle training and exercises
10845887|NCT00270998|EG002|Reported Event|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
10845888|NCT00271024|BG000|Baseline|Naltrexone - MALE|Males receiving naltrexone as part of the trial
10845889|NCT00271024|BG001|Baseline|Placebo - MALE|Males receiving placebo as part of the trial
10845890|NCT00271024|BG002|Baseline|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
10845891|NCT00271024|BG003|Baseline|Placebo - FEMALE|Females receiving placebo as part of the trial
11224332|NCT02359877|OG007|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
11224333|NCT02359877|OG008|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
11224334|NCT02359877|OG009|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
11224335|NCT02359877|OG000|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
11224336|NCT02359877|OG001|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
11003473|NCT01072201|EG001|Reported Event|Ultrabrite Toothpaste|sodium fluoride control (placebo)
11003474|NCT01072331|BG000|Baseline|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
11003475|NCT01072331|BG001|Baseline|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
11003476|NCT01072331|BG002|Baseline|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
11003477|NCT01072331|BG003|Baseline|Total|Total of all reporting groups
11003478|NCT01072331|FG000|Participant Flow|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
11003479|NCT01072331|FG001|Participant Flow|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
11003480|NCT01072331|FG002|Participant Flow|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
11003481|NCT01072331|OG000|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
11003482|NCT01072331|OG001|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
11003483|NCT01072331|OG002|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
11003484|NCT01072331|EG000|Reported Event|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
11003485|NCT01072331|EG001|Reported Event|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
11003486|NCT01072331|EG002|Reported Event|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
11003487|NCT01072344|BG000|Baseline|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
11003488|NCT01072344|BG001|Baseline|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
11003489|NCT01072344|BG002|Baseline|Total|Total of all reporting groups
11003490|NCT01072344|FG000|Participant Flow|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
11003491|NCT01072344|FG001|Participant Flow|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
11003492|NCT01072344|OG000|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
11003493|NCT01072344|OG001|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
11003494|NCT01072344|EG000|Reported Event|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
10845892|NCT00271024|BG004|Baseline|Total|Total of all reporting groups
10845893|NCT00271024|FG000|Participant Flow|Naltrexone - MALE|Males receiving naltrexone as part of the trial
10845894|NCT00271024|FG001|Participant Flow|Placebo - MALE|Males receiving placebo as part of the trial
11003495|NCT01072344|EG001|Reported Event|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
11003496|NCT01072357|BG000|Baseline|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
11003497|NCT01072357|BG001|Baseline|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
11003498|NCT01072357|BG002|Baseline|Total|Total of all reporting groups
11003499|NCT01072357|FG000|Participant Flow|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
11003500|NCT01072357|FG001|Participant Flow|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
11003501|NCT01072357|OG000|Outcome|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
11224337|NCT02359877|OG000|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
11224338|NCT02359877|OG001|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
11224339|NCT02359877|EG000|Reported Event|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
11003502|NCT01072357|OG001|Outcome|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
11003503|NCT01072357|EG000|Reported Event|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
11003504|NCT01072357|EG001|Reported Event|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
11003505|NCT01072396|BG000|Baseline|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
11224340|NCT02359877|EG001|Reported Event|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
11224341|NCT02359877|EG002|Reported Event|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
11224342|NCT02359877|EG003|Reported Event|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
10845895|NCT00271024|FG002|Participant Flow|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
11003506|NCT01072396|BG001|Baseline|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
11003507|NCT01072396|BG002|Baseline|Total|Total of all reporting groups
11003508|NCT01072396|FG000|Participant Flow|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
11003509|NCT01072396|FG001|Participant Flow|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
11003510|NCT01072396|OG000|Outcome|Placebo|Patients who received placebo in period one or period two
11003511|NCT01072396|OG001|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
11003512|NCT01072396|EG000|Reported Event|Placebo|Patients who received placebo in period one or period two
11003513|NCT01072396|EG001|Reported Event|Tiotropium|Patients who received tiotropium in period one or period two
11003514|NCT01072409|BG000|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint.
11003515|NCT01072409|FG000|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint.
11224343|NCT02359877|EG004|Reported Event|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
11224344|NCT02359877|EG005|Reported Event|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
11224345|NCT02359877|EG006|Reported Event|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
11224346|NCT02359877|EG007|Reported Event|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
11224347|NCT02359877|EG008|Reported Event|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
11224348|NCT02359877|EG009|Reported Event|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
11224349|NCT02359877|EG010|Reported Event|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
11224350|NCT02359877|EG011|Reported Event|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
11224351|NCT02359890|BG000|Baseline|THERMOCOOL SMARTTOUCH® SF Family of Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
11224352|NCT02359890|FG000|Participant Flow|THERMOCOOL SMARTTOUCH® SF Family of Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
11224353|NCT02359890|OG000|Outcome|THERMOCOOL SMARTTOUCH® SF Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
11003516|NCT01072409|OG000|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint.
11224354|NCT02359890|EG000|Reported Event|THERMOCOOL SMARTTOUCH® SF Family of Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
11224355|NCT02359903|BG000|Baseline|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
11224356|NCT02359903|BG001|Baseline|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
11224357|NCT02359903|BG002|Baseline|Total|Total of all reporting groups
10878582|NCT00453193|EG000|Reported Event|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
10878583|NCT00453206|BG000|Baseline|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
10878584|NCT00453206|FG000|Participant Flow|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
10878585|NCT00453206|OG000|Outcome|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
10878586|NCT00453206|EG000|Reported Event|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
10878587|NCT00453310|BG000|Baseline|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
10878588|NCT00453310|FG000|Participant Flow|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
10878589|NCT00453310|OG000|Outcome|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
10878590|NCT00453310|EG000|Reported Event|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
10878591|NCT00453336|BG000|Baseline|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
11003517|NCT01072409|EG000|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint.
11003518|NCT01072448|BG000|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11224358|NCT02359903|FG000|Participant Flow|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
11224359|NCT02359903|FG001|Participant Flow|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
11224360|NCT02359903|OG000|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
11224361|NCT02359903|OG001|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
11224362|NCT02359903|EG000|Reported Event|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
11224363|NCT02359903|EG001|Reported Event|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
11224364|NCT02359916|BG000|Baseline|Baseline 1|Snacks sold under equal pricing, no delays. Baseline 1 was always the first condition at all vending sites.
11224365|NCT02359916|BG001|Baseline|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
11224366|NCT02359916|BG002|Baseline|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
11224367|NCT02359916|BG003|Baseline|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
11224368|NCT02359916|BG004|Baseline|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
11224369|NCT02359916|BG005|Baseline|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
11224370|NCT02359916|BG006|Baseline|Baseline 2|Snacks sold under equal pricing, no delays. Baseline 2 was always the last condition at all vending sites.
11224371|NCT02359916|BG007|Baseline|Total|Total of all reporting groups
11224372|NCT02359916|FG000|Participant Flow|Baseline 1|Snacks sold under equal pricing, no delays. Baseline 1 was always the first condition at all vending sites.
11224373|NCT02359916|FG001|Participant Flow|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
11224374|NCT02359916|FG002|Participant Flow|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
11224375|NCT02359916|FG003|Participant Flow|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
10845896|NCT00271024|FG003|Participant Flow|Placebo - FEMALE|Females receiving placebo as part of the trial
11224376|NCT02359916|FG004|Participant Flow|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
10845897|NCT00271024|OG000|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
10845898|NCT00271024|OG001|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
10845899|NCT00271024|OG002|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
10845900|NCT00271024|OG003|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
10845901|NCT00271024|OG000|Outcome|Placebo|Participants receiving Placebo as part of the trial
10845902|NCT00271024|OG001|Outcome|Naltrexone|Participants receiving Naltrexone as part of the trial
10845903|NCT00271024|EG000|Reported Event|Placebo|Participants receiving Placebo as part of the trial
10845904|NCT00271024|EG001|Reported Event|Naltrexone|Participants receiving Naltrexone as part of the trial
10845905|NCT00271154|BG000|Baseline|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
10845906|NCT00271154|BG001|Baseline|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
10845907|NCT00271154|BG002|Baseline|Total|Total of all reporting groups
10845908|NCT00271154|FG000|Participant Flow|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
10845909|NCT00271154|FG001|Participant Flow|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
10845910|NCT00271154|OG000|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
11224377|NCT02359916|FG005|Participant Flow|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
11224378|NCT02359916|FG006|Participant Flow|Baseline 2|Snacks sold under equal pricing, no delays. Baseline 2 was always the last condition at all vending sites.
11224379|NCT02359916|OG000|Outcome|Baseline|Snacks sold under equal pricing, no delays. Data from Baseline 1 and 2 were combined in this analysis.
11224380|NCT02359916|OG001|Outcome|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
11224381|NCT02359916|OG002|Outcome|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
10845911|NCT00271154|OG001|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
10845912|NCT00271154|EG000|Reported Event|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
10845913|NCT00271154|EG001|Reported Event|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
10845914|NCT00271154|EG002|Reported Event|Not Randomized|These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
11224382|NCT02359916|OG003|Outcome|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
11224383|NCT02359916|OG004|Outcome|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
11224384|NCT02359916|OG005|Outcome|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
11224385|NCT02359916|OG000|Outcome|Baseline|Snacks sold under equal pricing, no delays
11224386|NCT02359916|EG000|Reported Event|Baseline|Snacks sold under equal pricing, no delays
11224387|NCT02359916|EG001|Reported Event|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
11224388|NCT02359916|EG002|Reported Event|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
11224389|NCT02359916|EG003|Reported Event|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
11224390|NCT02359916|EG004|Reported Event|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
11224391|NCT02359916|EG005|Reported Event|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
11224392|NCT02359955|BG000|Baseline|Group 1|"edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture~zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture~anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
10845915|NCT00271219|BG000|Baseline|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
10845916|NCT00271219|BG001|Baseline|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
10845917|NCT00271219|BG002|Baseline|Total|Total of all reporting groups
10845918|NCT00271219|FG000|Participant Flow|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
10845919|NCT00271219|FG001|Participant Flow|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
10845920|NCT00271219|OG000|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
10845921|NCT00271219|OG001|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
10845922|NCT00271219|OG000|Outcome|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
10845923|NCT00271219|OG001|Outcome|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
10845924|NCT00271219|EG000|Reported Event|Methadone: Mothers|"Methadone~Methadone : daily oral dosing 20-140 mg"
10845925|NCT00271219|EG001|Reported Event|Buprenorphine: Mothers|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
10845926|NCT00271219|EG002|Reported Event|Methadone: Neonates|Neonates born to mothers maintained on methadone
10845927|NCT00271219|EG003|Reported Event|Buprenorphine: Neonates|Neonates born to mothers maintained on buprenorphine
10845928|NCT00271375|BG000|Baseline|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
10845929|NCT00271375|BG001|Baseline|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
10845930|NCT00271375|BG002|Baseline|Control Group Usual Care|Control: Control group usual care
10845931|NCT00271375|BG003|Baseline|Total|Total of all reporting groups
10845932|NCT00271375|FG000|Participant Flow|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
10845933|NCT00271375|FG001|Participant Flow|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
10845934|NCT00271375|FG002|Participant Flow|Control Group Usual Care|Control: Control group usual care
10845935|NCT00271375|OG000|Outcome|Overall Evaluation|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
10845936|NCT00271375|OG000|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
10845937|NCT00271375|OG001|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
10845938|NCT00271375|OG002|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
10845939|NCT00271375|EG000|Reported Event|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
10845940|NCT00271375|EG001|Reported Event|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
10845941|NCT00271375|EG002|Reported Event|Arm 3: Control Group Usual Care|Control: Control group usual care
10845942|NCT00271505|BG000|Baseline|Carboplatin, Docetaxel, and Bevacizumab|Forty patients were treated with up to 6 cycles of carboplatin (AUC 6), docetaxel (75 mg/m2), and bevacizumab (15 mg/kg) on Day 1 every 21 days. Patients with an objective response or stable disease received maintenance bevacizumab (15 mg/kg) every 21 days until disease progression. The primary endpoint was median progression-free survival. Six cycles of chemotherapy plus bevacizumab were planned. Patients who demonstrated stable disease (SD), partial response (PR), or complete response (CR) to treatment continued on single-agent bevacizumab 15 mg/kg every 21 days until disease progression or intolerable toxicity. Patients who discontinued chemotherapy before 6 cycles of treatment were also allowed to continue on single-agent bevacizumab in the absence of progressive disease (PD).
10845943|NCT00271505|FG000|Participant Flow|Carboplatin (AUC 6), Docetaxel (75 mg/m2), and Bevacizumab (|Patients were treated with up to 6 cycles of carboplatin (AUC 6), docetaxel (75 mg/m2), and bevacizumab (15 mg/kg) on Day 1 every 21 days. Patients with an objective response or stable disease received maintenance bevacizumab (15 mg/kg) every 21 days until disease progression. The primary endpoint was median progression-free survival. Six cycles of chemotherapy plus bevacizumab were planned. Patients who demonstrated stable disease (SD), partial response (PR), or complete response (CR) to treatment continued on single-agent bevacizumab 15 mg/kg every 21 days until disease progression or intolerable toxicity. Patients who discontinued chemotherapy before 6 cycles of treatment were also allowed to continue on single-agent bevacizumab in the absence of progressive disease (PD).
10845944|NCT00271505|OG000|Outcome|Carboplatin, Docetaxel, and Bevacizumab|Up to 6 cycles of carboplatin (AUC 6), Tocetaxel (75 mg/m2), and Bevacizumab (15 mg/kg) on Day 1 every 21 days
10845945|NCT00271505|OG000|Outcome|Carboplatin,Docetaxel, and Bevacizumab|"Up to 6 cycles of carboplatin (AUC 6), Tocetaxel (75 mg/m2), and Bevacizumab (15 mg/kg) on Day 1 every 21 days"
10845946|NCT00271505|EG000|Reported Event|Carboplatin,Docetaxel, and Bevacizumab|Up to 6 cycles of carboplatin (AUC 6), Tocetaxel (75 mg/m2), and Bevacizumab (15 mg/kg) on Day 1 every 21 days
10845947|NCT00271570|BG000|Baseline|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
10845948|NCT00271570|BG001|Baseline|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
10845949|NCT00271570|BG002|Baseline|Total|Total of all reporting groups
10845950|NCT00271570|FG000|Participant Flow|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
10845951|NCT00271570|FG001|Participant Flow|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
10845952|NCT00271570|OG000|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
10845953|NCT00271570|OG001|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
10845954|NCT00271570|EG000|Reported Event|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
10845955|NCT00271570|EG001|Reported Event|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
10845956|NCT00271596|BG000|Baseline|Citalopram|20mg daily citalopram
11003519|NCT01072448|BG001|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11003520|NCT01072448|BG002|Baseline|Total|Total of all reporting groups
11003521|NCT01072448|FG000|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11003522|NCT01072448|FG001|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11003523|NCT01072448|OG000|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11003524|NCT01072448|OG001|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11003525|NCT01072448|EG000|Reported Event|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11003526|NCT01072448|EG001|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11003527|NCT01072500|BG000|Baseline|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
11003528|NCT01072500|BG001|Baseline|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
11003529|NCT01072500|BG002|Baseline|Total|Total of all reporting groups
11003530|NCT01072500|FG000|Participant Flow|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
11003531|NCT01072500|FG001|Participant Flow|Successful Aging (Health Education)|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
11003532|NCT01072500|OG000|Outcome|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
11003533|NCT01072500|OG001|Outcome|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
11003534|NCT01072500|OG000|Outcome|Physical Activity|"The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.~Physical Activity: The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling."
11003535|NCT01072500|OG001|Outcome|Successful Aging|"The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.~Successful Aging: The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises."
11003536|NCT01072500|EG000|Reported Event|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
11003537|NCT01072500|EG001|Reported Event|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
11003538|NCT01072539|BG000|Baseline|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
11003539|NCT01072539|FG000|Participant Flow|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
11003540|NCT01072539|OG000|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
11003541|NCT01072539|EG000|Reported Event|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
11224393|NCT02359955|BG001|Baseline|Group 2|"edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture~zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture~anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
11003542|NCT01072617|BG000|Baseline|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
11003543|NCT01072617|FG000|Participant Flow|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
11099074|NCT01579565|FG001|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11224394|NCT02359955|BG002|Baseline|Total|Total of all reporting groups
11224395|NCT02359955|FG000|Participant Flow|Zero-degree Teeth, Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
11224396|NCT02359955|FG001|Participant Flow|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
11224397|NCT02359955|OG000|Outcome|Group 1 Zero Degree Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
11224398|NCT02359955|OG001|Outcome|Group 2 Anatomic Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
11224399|NCT02359955|OG002|Outcome|Group 1 Anatomic Teeth|
11224400|NCT02359955|OG003|Outcome|Group 2 Zero Degree Teeth|
11224401|NCT02359955|OG000|Outcome|Amp Value of Right Masseter of Zero Degree Teeth|emg parameter of edentulous patients treated with zero-degree teeth complete denture
11224402|NCT02359955|OG001|Outcome|Amp Value of Left Masseter of Zero Degree Teeth|
11224403|NCT02359955|OG002|Outcome|Amp Value of Right Master of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
11224404|NCT02359955|OG003|Outcome|Amp Value of Left Masseter of Anatomic Teeth|
11224405|NCT02359955|OG000|Outcome|Duration of Right Masseter of Zero Degree Teeth|emg parameter of patients treated with zero degree teeth
11224406|NCT02359955|OG001|Outcome|Duration of Left Masseter of Zero Degree Teeth|
11224407|NCT02359955|OG002|Outcome|Duration of Right Masster of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
11224408|NCT02359955|OG003|Outcome|Duration of Left Masseter of Anatomic Teeth|
11224409|NCT02359955|EG000|Reported Event|Zero Degree Teeth,Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
11224410|NCT02359955|EG001|Reported Event|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
11224411|NCT02360085|BG000|Baseline|Cervical Myelopathy Undergoing Spine Surgery|This is a prospective, single-center, observational study in adult (aged 18-70 years) patients undergoing elective anterior or posterior cervical decompression and fusion for cervical myelopathy in our institution during the period from Sept 2017 to June 2018.
11224412|NCT02360085|FG000|Participant Flow|Cervical Myelopathy Undergoing Spine Surgery|This is a prospective, single-center, observational study in adult (aged 18-70 years) patients undergoing elective anterior or posterior cervical decompression and fusion for cervical myelopathy in our institution during the period from Sept 2017 to June 2018.
11224413|NCT02360085|OG000|Outcome|Hypotension Group|HRV analysis in hypotension group
11224414|NCT02360085|OG001|Outcome|No Hypotension Group|HRV analysis in stable group
11224415|NCT02360085|OG000|Outcome|Hypotension Group|VLF, LF and HF analysis
11224416|NCT02360085|OG001|Outcome|No Hypotension Group|VLF, LF and HF analysis
11224417|NCT02360085|OG000|Outcome|Hypotension Group|Mean Arterial Pressure analysis in hypotension group
11224418|NCT02360085|OG001|Outcome|No Hypotension Group|Mean Arterial Pressure analysis in no hypotension
11224419|NCT02360085|OG000|Outcome|Hypotension Group|Low Frequency to High Frequency ratio
11224420|NCT02360085|OG001|Outcome|No Hypotension Group|Low Frequency to High Frequency ratio
11224421|NCT02360085|EG000|Reported Event|All Patients|Heart Rate Variability in Patients with Cervical Myelopathy
11224422|NCT02360098|BG000|Baseline|Agitated Emergence|Demographic variables of patients woke up agitated from anesthesia
11224423|NCT02360098|BG001|Baseline|Smooth Emergence|Demographic variables of patients with smooth wake up from anesthesia
11224424|NCT02360098|BG002|Baseline|Total|Total of all reporting groups
11224425|NCT02360098|FG000|Participant Flow|Agitated Emergence and Smooth Emergence|Number of consented patients to participate in the study
11224426|NCT02360098|OG000|Outcome|Agitated Emergence|Comparison of volumes of the hippocampus, thalamus and amygdala
11224427|NCT02360098|OG001|Outcome|Smooth Emergence|Comparison of volumes of the hippocampus, thalamus and amygdala
11224428|NCT02360098|EG000|Reported Event|Agitated Emergence and Smooth Emergence|Demographic variables and anesthetic agent use
11003544|NCT01072617|OG000|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
11224429|NCT02360124|BG000|Baseline|Control|"instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
11224430|NCT02360124|BG001|Baseline|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
11224431|NCT02360124|BG002|Baseline|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
11224432|NCT02360124|BG003|Baseline|Total|Total of all reporting groups
11224433|NCT02360124|FG000|Participant Flow|Control|"instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
11224434|NCT02360124|FG001|Participant Flow|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
11224435|NCT02360124|FG002|Participant Flow|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
11224436|NCT02360124|OG000|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
11224437|NCT02360124|OG001|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
11224438|NCT02360124|OG002|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
11224439|NCT02360124|OG000|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
10845957|NCT00271596|BG001|Baseline|Placebo|Matching daily placebo
11224440|NCT02360124|OG002|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces~saturated potassium iodide solution: topical application of SDF solution followed by KI solution onto tooth root surfaces"
10845958|NCT00271596|BG002|Baseline|Total|Total of all reporting groups
10845959|NCT00271596|FG000|Participant Flow|Citalopram|20mg daily citalopram
11003545|NCT01072617|OG000|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
11003546|NCT01072617|EG000|Reported Event|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
11003547|NCT01072630|BG000|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
11003548|NCT01072630|BG001|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
11003549|NCT01072630|BG002|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
11003550|NCT01072630|BG003|Baseline|Total|Total of all reporting groups
11003551|NCT01072630|FG000|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
11003552|NCT01072630|FG001|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
11003553|NCT01072630|FG002|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
11003554|NCT01072630|OG000|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
11003555|NCT01072630|OG001|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
11003556|NCT01072630|OG002|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
11003557|NCT01072630|OG002|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
11003558|NCT01072630|EG000|Reported Event|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
11003559|NCT01072630|EG001|Reported Event|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
11003560|NCT01072630|EG002|Reported Event|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
11003561|NCT01072643|BG000|Baseline|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
11003562|NCT01072643|FG000|Participant Flow|Dexmedetomidine (DEX) 1 mcg/kg Bolus|"To study safety of Dexmedetomidine (DEX) with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
11003563|NCT01072643|OG000|Outcome|Subject 1|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
11003564|NCT01072643|OG001|Outcome|Subject 2|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
11003565|NCT01072643|OG002|Outcome|Subject 3|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
11003566|NCT01072643|OG003|Outcome|Subject 4|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
11003567|NCT01072643|OG000|Outcome|Subject 1|Efficacy of sedation with DEX
11003568|NCT01072643|OG001|Outcome|Subject 2|Efficacy of sedation with DEX
11003569|NCT01072643|OG002|Outcome|Subject 3|Efficacy of sedation with DEX
11099075|NCT01579565|OG000|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11099076|NCT01579565|OG001|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11099077|NCT01579565|OG000|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11099078|NCT01579565|OG001|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11099079|NCT01579565|EG000|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11099080|NCT01579565|EG001|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11099081|NCT01579578|BG000|Baseline|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
11099082|NCT01579578|BG001|Baseline|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
11099083|NCT01579578|BG002|Baseline|Total|Total of all reporting groups
11099084|NCT01579578|FG000|Participant Flow|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
11099085|NCT01579578|FG001|Participant Flow|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
11099086|NCT01579578|OG000|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
11099087|NCT01579578|OG001|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
11099088|NCT01579578|EG000|Reported Event|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
11099089|NCT01579578|EG001|Reported Event|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
11099090|NCT01579669|BG000|Baseline|Autistic Adults|Adults on the autism spectrum
11099091|NCT01579669|BG001|Baseline|Primary Care Providers|Primary care providers taking care of autistic adults participating in this study
11099092|NCT01579669|BG002|Baseline|Total|Total of all reporting groups
11099093|NCT01579669|FG000|Participant Flow|Autistic Adults|Adults on the autism spectrum
11099094|NCT01579669|FG001|Participant Flow|Primary Care Providers|Participants' primary care providers
11099095|NCT01579669|OG000|Outcome|Autistic Adults|Adults on the autism spectrum
11099096|NCT01579669|OG000|Outcome|Primary Care Providers|Participants' primary care providers
11099097|NCT01579669|EG000|Reported Event|Autistic Adults|Adults on the autism spectrum
11099098|NCT01579669|EG001|Reported Event|Primary Care Providers|Primary care providers of autistic adults participating in the study.
11099099|NCT01579747|BG000|Baseline|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
11099100|NCT01579747|BG001|Baseline|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
11099101|NCT01579747|BG002|Baseline|Total|Total of all reporting groups
11003570|NCT01072643|OG003|Outcome|Subject 4|Efficacy of sedation with DEX
11003571|NCT01072643|OG000|Outcome|Subject 1|Quantify the effect of DEX on PVR in pediatric subjects with pulmonary hypertension and its dependence on baseline PVR
11003572|NCT01072643|OG001|Outcome|Subject 2|Quantify the effect of DEX on PVR in pediatric subjects with pulmonary hypertension and its dependence on baseline PVR
11003573|NCT01072643|OG002|Outcome|Subject 3|Quantify the effect of DEX on PVR in pediatric subjects with pulmonary hypertension and its dependence on baseline PVR
11003574|NCT01072643|OG003|Outcome|Subject 4|Quantify the effect of DEX on PVR in pediatric subjects with pulmonary hypertension and its dependence on baseline PVR
11003575|NCT01072643|OG000|Outcome|Subject 1|Obtain pharmacokinetic data in this population
11003576|NCT01072643|OG001|Outcome|Subject 2|Obtain pharmacokinetic data in this population
11003577|NCT01072643|OG002|Outcome|Subject 3|Obtain pharmacokinetic data in this population
11003578|NCT01072643|OG003|Outcome|Subject 4|Obtain pharmacokinetic data in this population
11003579|NCT01072643|OG000|Outcome|Subject 1|Demonstrate that DEX is a safe sedative in pediatric subjects with PHTN
11003580|NCT01072643|OG001|Outcome|Subject 2|Demonstrate that DEX is a safe sedative in pediatric subjects with PHTN
11003581|NCT01072643|OG002|Outcome|Subject 3|Demonstrate that DEX is a safe sedative in pediatric subjects with PHTN
11003582|NCT01072643|OG003|Outcome|Subject 4|Demonstrate that DEX is a safe sedative in pediatric subjects with PHTN
11003583|NCT01072643|EG000|Reported Event|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
11003584|NCT01072656|BG000|Baseline|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
11003585|NCT01072656|BG001|Baseline|Sham First|sham stimulation - IPG ON, at 0 Volt
11003586|NCT01072656|BG002|Baseline|Total|Total of all reporting groups
11003587|NCT01072656|FG000|Participant Flow|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
11003588|NCT01072656|FG001|Participant Flow|Sham First|sham stimulation - IPG ON, at 0 Volt
11003589|NCT01072656|OG000|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
11003590|NCT01072656|OG001|Outcome|Sham Stimulation|"IPG is set to ON but the voltage is set to 0V.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
11003591|NCT01072656|EG000|Reported Event|Active Stimulation (Phase V)|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
11003592|NCT01072656|EG001|Reported Event|Sham Stimulation (Phase V)|"IPG is set to ON but the voltage is set to 0V.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
11003593|NCT01072656|EG002|Reported Event|Phase I-IV|Phase I-IV is time frame of patient consent through surgery just prior to beginning Active v Sham Stimulation Phase.
11003594|NCT01072669|BG000|Baseline|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
11003595|NCT01072669|BG001|Baseline|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
11003596|NCT01072669|BG002|Baseline|Total|Total of all reporting groups
11003597|NCT01072669|FG000|Participant Flow|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
11099102|NCT01579747|FG000|Participant Flow|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
11099103|NCT01579747|FG001|Participant Flow|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
11099104|NCT01579747|OG000|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
11099105|NCT01579747|OG001|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
11099106|NCT01579747|EG000|Reported Event|Nerve Stimulation Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach using nerve stimulation
11099107|NCT01579747|EG001|Reported Event|Ultrasound Guided Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach when using an ultrasound
11099108|NCT01579812|BG000|Baseline|Metformin|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
11099109|NCT01579812|FG000|Participant Flow|Metformin|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
11099110|NCT01579812|OG000|Outcome|Metformin - All Patients Analyzed|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
11099111|NCT01579812|OG001|Outcome|Metformin - Patients With Persistent Disease Excluded|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.~Patients with persistent disease were excluded in this analysis."
11099112|NCT01579812|OG001|Outcome|Metformin - Patients Stage IIc/ III Ovarian Cancer|Patients with stage IIc/ III ovarian cancer receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
11099113|NCT01579812|OG002|Outcome|Metformin - Patients With Stage IV Ovarian Cancer|Patients with stage IV ovarian cancer receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
10845960|NCT00271596|FG001|Participant Flow|Placebo|Matching daily placebo
10845961|NCT00271596|OG000|Outcome|Citalopram|20mg daily citalopram
10845962|NCT00271596|OG001|Outcome|Placebo|Matching daily placebo
10845963|NCT00271596|EG000|Reported Event|Citalopram|20mg daily citalopram
10845964|NCT00271596|EG001|Reported Event|Placebo|Matching daily placebo
10845965|NCT00271609|BG000|Baseline|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
10845966|NCT00271609|BG001|Baseline|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
10845967|NCT00271609|BG002|Baseline|Total|Total of all reporting groups
10845968|NCT00271609|FG000|Participant Flow|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
10845969|NCT00271609|FG001|Participant Flow|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
10845970|NCT00271609|OG000|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
10845971|NCT00271609|OG001|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
10845972|NCT00271609|EG000|Reported Event|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
10845973|NCT00271609|EG001|Reported Event|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
10845974|NCT00271739|BG000|Baseline|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
10845975|NCT00271739|BG001|Baseline|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.
10845976|NCT00271739|BG002|Baseline|Total|Total of all reporting groups
10845977|NCT00271739|FG000|Participant Flow|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
10845978|NCT00271739|FG001|Participant Flow|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.
10845979|NCT00271739|OG000|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
11003598|NCT01072669|FG001|Participant Flow|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
11003599|NCT01072669|OG000|Outcome|Ambrisentan|Ambrisentan 5 mg daily for 1 month, then 10 mg daily for 2 months
11003600|NCT01072669|OG001|Outcome|Sugar Pill|Placebo, same appearing as Ambrisentan
11003601|NCT01072669|EG000|Reported Event|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
11003602|NCT01072669|EG001|Reported Event|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
11003603|NCT01072773|BG000|Baseline|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
11003604|NCT01072773|FG000|Participant Flow|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
11003605|NCT01072773|OG000|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
11003606|NCT01072773|EG000|Reported Event|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
11003607|NCT01072877|BG000|Baseline|Vehicle|"Injection of vehicle comparator~Placebo Vehicle: Placebo vehicle"
11003608|NCT01072877|BG001|Baseline|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam 0.125%
11003609|NCT01072877|BG002|Baseline|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam 0.5%
11003610|NCT01072877|BG003|Baseline|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam 1.0%
11003611|NCT01072877|BG004|Baseline|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam2.0%
11003612|NCT01072877|BG005|Baseline|Total|Total of all reporting groups
11003613|NCT01072877|FG000|Participant Flow|Vehicle|"Injection of vehicle comparator~Placebo Vehicle: Placebo vehicle"
11003614|NCT01072877|FG001|Participant Flow|Polidocanol Endovenous Microfoam 0.125%|"Polidocanol endovenous microfoam 0.125%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
11003615|NCT01072877|FG002|Participant Flow|Polidocanol Endovenous Microfoam 0.5%|"Polidocanol endovenous microfoam 0.5%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
11003616|NCT01072877|FG003|Participant Flow|Polidocanol Endovenous Microfoam 1.0%|"Polidocanol endovenous microfoam 1.0%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
11003617|NCT01072877|FG004|Participant Flow|Polidocanol Endovenous Microfoam 2.0%|"Polidocanol endovenous microfoam 2.0%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
11003618|NCT01072877|OG000|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
11003619|NCT01072877|OG001|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
11003620|NCT01072877|OG002|Outcome|Polidocanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
11003621|NCT01072877|OG003|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at 1.0% concentration
11003622|NCT01072877|OG004|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
11003623|NCT01072877|OG002|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
11003624|NCT01072877|OG003|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
11003625|NCT01072877|EG000|Reported Event|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
11003626|NCT01072877|EG001|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam at a 0.125% concentration
11003627|NCT01072877|EG002|Reported Event|Polidcanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
11003628|NCT01072877|EG003|Reported Event|Polidocanol Injectable Foam 1.0%|polidocanol injectable foam at a 1.0% concentration
11003629|NCT01072877|EG004|Reported Event|Polidocanol Endovenous Microfoam 2.0%|polidocanol injectable foam at a 2.0% concentration
11003630|NCT01072929|BG000|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
11003631|NCT01072929|BG001|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
11003632|NCT01072929|BG002|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
11003633|NCT01072929|BG003|Baseline|Total|Total of all reporting groups
11003634|NCT01072929|FG000|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
11003635|NCT01072929|FG001|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
11003636|NCT01072929|FG002|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
11003637|NCT01072929|OG000|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
11003638|NCT01072929|OG001|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
11003639|NCT01072929|OG002|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
11003640|NCT01072929|OG002|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
11003641|NCT01072929|EG000|Reported Event|ARMODAFINIL 150 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
11003642|NCT01072929|EG001|Reported Event|ARMODAFINIL 200 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
11003643|NCT01072929|EG002|Reported Event|PLACEBO|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
11003644|NCT01073020|BG000|Baseline|Laparoscopic Adjustable Gastric Band (LAGB)|Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device)
11003645|NCT01073020|BG001|Baseline|Intensive Medical Diabetes & Weight Management (LAGB Group)|"Intensive Medical Diabetes & Weight Management: Intensive Medical Diabetes & Weight Management (LAGB Group)~This group selected band as preferred surgery, but were randomized to medical management."
11003646|NCT01073020|BG002|Baseline|RYGB|Roux-en-Y Gastric Bypass (Surgery)
11003647|NCT01073020|BG003|Baseline|Intnnsive Medical Diabetes and Weight Management (RYGB Group)|"Intensive Medical Diabetes & Weight Management: Intensive Medical Diabetes & Weight Management (RYGB Group)~This group selected RYGB as preferred surgery, but were randomized to medical management."
11003648|NCT01073020|BG004|Baseline|Total|Total of all reporting groups
11003649|NCT01073020|FG000|Participant Flow|Laparoscopic Adjustable Gastric Band (LAGB)|"Laparoscopic Adjustable Gastric Band (LAGB): Allergan Adjustable Gastric Band (Device)~Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)"
11003650|NCT01073020|FG001|Participant Flow|Intensive Medical Diabetes & Weight Management (LAGB Grp)|Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)
11003651|NCT01073020|FG002|Participant Flow|RYGB|"Roux-en-Y Gastric Bypass (Surgery)~Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)"
11003652|NCT01073020|FG003|Participant Flow|Intensive Medical Diabetes & Weight Management (RYGB Grp)|Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)
11003653|NCT01073020|OG000|Outcome|LAGB|"Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device)~Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)"
11003654|NCT01073020|OG001|Outcome|Intensive Medical Diabetes & Weight Management (LAGB Grp)|Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)
11003655|NCT01073020|OG002|Outcome|RYGB|"Roux-en-Y Gastric Bypass (Surgery)~Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)"
11003656|NCT01073020|OG003|Outcome|Intensive Medical Diabetes & Weight Management (RYGB Grp)|Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)
11003657|NCT01073020|EG000|Reported Event|Laparoscopic Adjustable Gastric Band Surgery|Surgical Implantation of Allergan Adjustable Gastric Band (Device)
11003658|NCT01073020|EG001|Reported Event|Intensive Medical Diabetes and Weight Management: Band Group|
11003659|NCT01073020|EG002|Reported Event|Roux-en-Y Gastric Bypass (RYGB) Surgery|
11003660|NCT01073020|EG003|Reported Event|Intensive Medical Diabetes and Weight Management: RYGB Group|
11003661|NCT01073163|BG000|Baseline|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
11003662|NCT01073163|FG000|Participant Flow|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
11003663|NCT01073163|OG000|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
11003664|NCT01073163|OG000|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
11003665|NCT01073163|OG000|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
11003666|NCT01073163|OG001|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
11003667|NCT01073163|OG002|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
11003668|NCT01073163|EG000|Reported Event|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
11003669|NCT01073267|BG000|Baseline|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
11003670|NCT01073267|FG000|Participant Flow|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
11003671|NCT01073267|OG000|Outcome|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
11003672|NCT01073267|EG000|Reported Event|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
11003673|NCT01073293|BG000|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
11003674|NCT01073293|BG001|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
11003675|NCT01073293|BG002|Baseline|Total|Total of all reporting groups
11003676|NCT01073293|FG000|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
11003677|NCT01073293|FG001|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
11003678|NCT01073293|OG000|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
11003679|NCT01073293|OG001|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
11003680|NCT01073293|EG000|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1
11003681|NCT01073293|EG001|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
10845980|NCT00271739|OG001|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.
11003682|NCT01073449|BG000|Baseline|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
11003683|NCT01073449|FG000|Participant Flow|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
11003684|NCT01073449|OG000|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
11003685|NCT01073449|EG000|Reported Event|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
11003686|NCT01073462|BG000|Baseline|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
11003687|NCT01073462|FG000|Participant Flow|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
11003688|NCT01073462|OG000|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
11003689|NCT01073462|EG000|Reported Event|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years
11003690|NCT01073566|BG000|Baseline|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
11003691|NCT01073566|BG001|Baseline|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
11003692|NCT01073566|BG002|Baseline|Total|Total of all reporting groups
11003693|NCT01073566|FG000|Participant Flow|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
11003694|NCT01073566|FG001|Participant Flow|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
11003695|NCT01073566|OG000|Outcome|Finesse|Bolus Patch
11003696|NCT01073566|OG001|Outcome|Usual Injection Device|Pen/Syringe
11003697|NCT01073566|EG000|Reported Event|Finesse|Bolus Patch
11003698|NCT01073566|EG001|Reported Event|Usual Injection Device|Pen/Syringe
11003699|NCT01073605|BG000|Baseline|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003700|NCT01073605|BG001|Baseline|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003701|NCT01073605|BG002|Baseline|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003702|NCT01073605|BG003|Baseline|Total|Total of all reporting groups
11003703|NCT01073605|FG000|Participant Flow|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003704|NCT01073605|FG001|Participant Flow|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003705|NCT01073605|FG002|Participant Flow|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003706|NCT01073605|OG000|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003707|NCT01073605|OG001|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003708|NCT01073605|OG002|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003709|NCT01073605|EG000|Reported Event|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003710|NCT01073605|EG001|Reported Event|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003711|NCT01073605|EG002|Reported Event|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
11003712|NCT01073618|BG000|Baseline|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
11003713|NCT01073618|FG000|Participant Flow|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
11003714|NCT01073618|OG000|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
11003715|NCT01073618|EG000|Reported Event|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
11003716|NCT01073631|BG000|Baseline|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
11003717|NCT01073631|FG000|Participant Flow|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
11003718|NCT01073631|OG000|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
11003719|NCT01073631|EG000|Reported Event|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
11003720|NCT01073657|BG000|Baseline|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
11003721|NCT01073657|BG001|Baseline|Active Control|Veterans recived peer services that did not address educational goals
11003722|NCT01073657|BG002|Baseline|Total|Total of all reporting groups
11003723|NCT01073657|FG000|Participant Flow|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals
11003724|NCT01073657|FG001|Participant Flow|General Peer Support|Veterans received peer services that did not address educational goals
11003725|NCT01073657|OG000|Outcome|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals Intervention group
11003726|NCT01073657|OG001|Outcome|General Peer Support|Matched peer attention no supported education service
11003727|NCT01073657|EG000|Reported Event|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
11003728|NCT01073657|EG001|Reported Event|Active Control|Veterans received matched peer attention that did not address educational goals
11003729|NCT01073865|BG000|Baseline|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
11003730|NCT01073865|BG001|Baseline|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
11003731|NCT01073865|BG002|Baseline|Total|Total of all reporting groups
11003732|NCT01073865|FG000|Participant Flow|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
11003733|NCT01073865|FG001|Participant Flow|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
11003734|NCT01073865|OG000|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
11003735|NCT01073865|OG001|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
11003736|NCT01073865|EG000|Reported Event|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
11003737|NCT01073865|EG001|Reported Event|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
11003738|NCT01073930|BG000|Baseline|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
11003739|NCT01073930|BG001|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
11003740|NCT01073930|BG002|Baseline|Total|Total of all reporting groups
11003741|NCT01073930|FG000|Participant Flow|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
11003742|NCT01073930|FG001|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
11003743|NCT01073930|OG000|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
11003744|NCT01073930|OG001|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
11003745|NCT01073930|EG000|Reported Event|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
11003746|NCT01073930|EG001|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
11003747|NCT01073943|BG000|Baseline|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
11003748|NCT01073943|BG001|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
11003749|NCT01073943|BG002|Baseline|Total|Total of all reporting groups
11003750|NCT01073943|FG000|Participant Flow|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
11003751|NCT01073943|FG001|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
11003752|NCT01073943|OG000|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
11003753|NCT01073943|OG001|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
11003754|NCT01073943|EG000|Reported Event|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
11003755|NCT01073943|EG001|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
11003756|NCT01074008|BG000|Baseline|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11224503|NCT02360475|BG000|Baseline|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11099114|NCT01579812|EG000|Reported Event|Metformin|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
11099115|NCT01579916|BG000|Baseline|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
11099116|NCT01579916|BG001|Baseline|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
11099117|NCT01579916|BG002|Baseline|TOTAL|Total of all reporting groups
11099118|NCT01579916|FG000|Participant Flow|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
11099119|NCT01579916|FG001|Participant Flow|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
11099120|NCT01579916|OG000|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
11099121|NCT01579916|OG001|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
11099122|NCT01579916|EG000|Reported Event|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
11099123|NCT01579916|EG001|Reported Event|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
11099124|NCT01580020|BG000|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11099125|NCT01580020|BG001|Baseline|Dexamethasone|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
11099126|NCT01580020|BG002|Baseline|Total|Total of all reporting groups
11099127|NCT01580020|FG000|Participant Flow|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11099128|NCT01580020|FG001|Participant Flow|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
11099129|NCT01580020|FG002|Participant Flow|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally
11099130|NCT01580020|FG003|Participant Flow|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
11099131|NCT01580020|OG000|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11099132|NCT01580020|OG001|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
11099133|NCT01580020|OG002|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11099134|NCT01580020|OG003|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
11099135|NCT01580020|EG000|Reported Event|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11099136|NCT01580020|EG001|Reported Event|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
11099137|NCT01580020|EG002|Reported Event|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11099138|NCT01580020|EG003|Reported Event|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
11099139|NCT01580072|BG000|Baseline|Control Group|Participants in the control group receive usual care.
11003757|NCT01074008|BG001|Baseline|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003758|NCT01074008|BG002|Baseline|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003759|NCT01074008|BG003|Baseline|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003760|NCT01074008|BG004|Baseline|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003761|NCT01074008|BG005|Baseline|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003762|NCT01074008|BG006|Baseline|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003763|NCT01074008|BG007|Baseline|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003764|NCT01074008|BG008|Baseline|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003765|NCT01074008|BG009|Baseline|Total|Total of all reporting groups
11003766|NCT01074008|FG000|Participant Flow|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003767|NCT01074008|FG001|Participant Flow|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003768|NCT01074008|FG002|Participant Flow|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003769|NCT01074008|FG003|Participant Flow|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003770|NCT01074008|FG004|Participant Flow|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003771|NCT01074008|FG005|Participant Flow|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003772|NCT01074008|FG006|Participant Flow|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003773|NCT01074008|FG007|Participant Flow|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11099140|NCT01580072|BG001|Baseline|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
11099141|NCT01580072|BG002|Baseline|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
11099142|NCT01580072|BG003|Baseline|Total|Total of all reporting groups
11099143|NCT01580072|FG000|Participant Flow|Control Group|Participants in the control group receive usual care.
11099144|NCT01580072|FG001|Participant Flow|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
11099145|NCT01580072|FG002|Participant Flow|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
11099146|NCT01580072|OG000|Outcome|Control Group|Participants in the control group receive usual care.
11099147|NCT01580072|OG001|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
11099148|NCT01580072|OG002|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
11099149|NCT01580072|EG000|Reported Event|Control Group|Participants in the control group receive usual care.
11099150|NCT01580072|EG001|Reported Event|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
11099151|NCT01580072|EG002|Reported Event|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
11099152|NCT01580098|BG000|Baseline|Control Group|treatment as usual
11099153|NCT01580098|BG001|Baseline|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
11099154|NCT01580098|BG002|Baseline|Total|Total of all reporting groups
11099155|NCT01580098|FG000|Participant Flow|Control Group|treatment as usual
11099156|NCT01580098|FG001|Participant Flow|Self-monitoring for Patients With Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital."
11099157|NCT01580098|FG002|Participant Flow|Nurse-monitoring for Patients With Diabetes Mellitus Type 2|"nurse-monitoring for patients with Diabetes Mellitus~Nurses are entering vital parameters of the patient with mobile devices"
11099158|NCT01580098|OG000|Outcome|Control Group|treatment as usual
11099159|NCT01580098|OG001|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
11099160|NCT01580098|OG001|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
11099161|NCT01580098|EG000|Reported Event|Control Group|treatment as usual
11099162|NCT01580098|EG001|Reported Event|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Home nursing is also included. Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
11099163|NCT01580293|BG000|Baseline|BAY94-9027 On-demand Treatment, Main Trial|Participants received on-demand treatment with BAY94-9027 as an intravenous (IV)infusion at a dose as indicated based upon location and severity of bleeds (a maximum of 60 international units per kilogram [IU/kg]).
11099164|NCT01580293|BG001|Baseline|BAY94-9027 Prophylaxis Treatment, 2x/Week Dropped, Main Trial|4 participants dropped out during week 0-10
11099165|NCT01580293|BG002|Baseline|BAY94-9027 Prophylaxis Treatment, 2x/Week Failed, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. High bleeders (with 2 or more muscle or joint bleeds in the first 10 weeks) continued 2x/week infusion (2x/week 'failed') at a dose of 30 to 40 IU/kg.
11099166|NCT01580293|BG003|Baseline|BAY94-9027 Prophylaxis Treatment, 2x/Week Forced, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants with < 2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen. Participants enrolled after randomization arms were filled continued 2x/week treatment at a dose of 30-40 IU/kg (2x/week 'forced').
11099167|NCT01580293|BG004|Baseline|BAY94-9027 Prophylaxis Treatment, Every 5 Days, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants with < 2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen, participants randomized to the every 5 days treatment arm were to begin treatment with 45 IU/kg every 5 days with the option to increase dose up to 60 IU/kg/infusion.
11099168|NCT01580293|BG005|Baseline|BAY94-9027 Prophylaxis Treatment, Every 7 Days, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants <2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen, participants randomized to the every 7 days treatment arm were to administer a dose of 60 IU/kg (maximum 6000 IU) every 7 days.
11099169|NCT01580293|BG006|Baseline|BAY94-9027 Treatment in Major Surgery, Part B Only|Participants treated in Part B only were included. Participants treated in Part A and continued in Part B were excluded. Participants who underwent major surgery received study drug during their hospital stay and up until hospital discharge or 3 weeks post-surgery, whichever came first. Participants were treated according to the type of procedure, using tailored doses (a maximum of 60 IU/kg) expected to maintain acceptable therapeutic level of FVIII activity.
11099170|NCT01580293|BG007|Baseline|Total|Total of all reporting groups
11099171|NCT01580293|FG000|Participant Flow|BAY94-9027 On-demand Treatment, Part A|Participants received on-demand treatment with BAY94-9027 as an intravenous (IV) infusion at a dose as indicated based upon location and severity of bleeds (a maximum of 60 international units per kilogram [IU/kg]). Participants entering extension either continued their on-demand treatment or switched to one of the prophylaxis regimens.
11099172|NCT01580293|FG001|Participant Flow|BAY94-9027 Prophylaxis Treatment, Part A|All participants started BAY94-9027 IV infusion, with 2x/week at a dose of 25 IU/kg for 10 weeks. Thereafter, participants with less than 2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen. High bleeders continued 2x/week infusion (2x/week 'failed'). Participants qualified to be randomized but enrolled after randomized arms were filled, remained on 2x/week treatment (2x/week 'forced' group). Participants entering extension either continued their prophylaxis regimen or switched to one of the other prophylaxis regimens.
11099173|NCT01580293|FG002|Participant Flow|BAY949027 Treatment in Major Surgery, Part B|Participants who underwent major surgery received study drug during their hospital stay up to 3 weeks post surgery. Participants were treated according to the type of procedure, using tailored doses (a maximum of 60 IU/kg/infusion) expected to maintain acceptable therapeutic level of FVIII activity.
11099174|NCT01580293|OG000|Outcome|BAY94-9027 On-demand Treatment, Main Trial|Participants received on-demand treatment with BAY94-9027 as an intravenous (IV)infusion at a dose as indicated based upon location and severity of bleeds (a maximum of 60 international units per kilogram [IU/kg]).
11099175|NCT01580293|OG001|Outcome|BAY94-9027 Prophylaxis Treatment, 2x/Week Failed, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. High bleeders (with 2 or more muscle or joint bleeds in the first 10 weeks) continued 2x/week infusion (2x/week 'failed') at a dose of 30 to 40 IU/kg.
11099176|NCT01580293|OG002|Outcome|BAY94-9027 Prophylaxis Treatment, 2x/Week Forced, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants with < 2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen. Participants enrolled after randomization arms were filled continued 2x/week treatment at a dose of 30-40 IU/kg (2x/week 'forced').
11099177|NCT01580293|OG003|Outcome|BAY94-9027 Prophylaxis Treatment, Every 5 Days, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants with < 2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen, participants randomized to the every 5 days treatment arm were to begin treatment with 45 IU/kg every 5 days with the option to increase dose up to 60 IU/kg/infusion.
11099178|NCT01580293|OG004|Outcome|BAY94-9027 Prophylaxis Treatment, Every 7 Days, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants <2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen, participants randomized to the every 7 days treatment arm were to administer a dose of 60 IU/kg (maximum 6000 IU) every 7 days.
11099179|NCT01580293|OG005|Outcome|BAY94-9027 Prophylaxis Treatment Total, Main Trial|All participants receiving an schedule of prophylaxis treatment, all prophylaxis arms combined.
11099180|NCT01580293|OG000|Outcome|BAY94-9027 On-demand Treatment, Extension|On-demand participants entering the Part A extension either continued their on-demand treatment or switched to one of the prophylaxis regimens.
11099181|NCT01580293|OG001|Outcome|BAY94-9027 Prophylaxis Treatment, 2x/Week, Extension|Prophylaxis participants entering the Part A extension were either to continue their prophylaxis regimen as it was at the conclusion of the main trial, or had the option of switching to one of the other prophylaxis regimens.
11099182|NCT01580293|OG002|Outcome|BAY94-9027 Prophylaxis Treatment, Every 5 Days, Extension|Prophylaxis participants entering the Part A extension were either to continue their prophylaxis regimen as it was at the conclusion of the main trial, or had the option of switching to one of the other prophylaxis regimens.
11099183|NCT01580293|OG003|Outcome|BAY94-9027 Prophylaxis Treatment, Every 7 Days, Extension|Prophylaxis participants entering the Part A extension were either to continue their prophylaxis regimen as it was at the conclusion of the main trial, or had the option of switching to one of the other prophylaxis regimens.
11099184|NCT01580293|OG004|Outcome|BAY94-9027 Prophylaxis Treatment, Variable, Extension|Participants changed their treatment regimens at least once after 1st week in extension.
11099185|NCT01580293|OG001|Outcome|BAY94-9027 Prophylaxis Treatment, Week 0-36, Main Trial|All participants in the prophylaxis arms started BAY94-9027 IV infusion, with 2x/week at a dose of 25 IU/kg for 10 weeks. Thereafter, participants with less than 2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen. High bleeders continued 2x/week infusion (2x/week 'failed'). Participants qualified to be randomized, but enrolled after randomized arms were filled, remained on 2x/week treatment (2x/week 'forced' group).
11099186|NCT01580293|OG000|Outcome|BAY94-9027 Prophylaxis Treatment, 2x/Week Failed, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. High bleeders (with 2 or more muscle or joint bleeds in the first 10 weeks) continued 2x/week infusion (2x/week 'failed') at a dose of 30 to 40 IU/kg.
11099187|NCT01580293|OG001|Outcome|BAY94-9027 Prophylaxis Treatment, 2x/Week Forced, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants with < 2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen. Participants enrolled after randomization arms were filled continued 2x/week treatment at a dose of 30-40 IU/kg (2x/week 'forced').
11099188|NCT01580293|OG002|Outcome|BAY94-9027 Prophylaxis Treatment, Every 5 Days, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants with < 2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen, participants randomized to the every 5 days treatment arm were to begin treatment with 45 IU/kg every 5 days with the option to increase dose up to 60 IU/kg/infusion.
11099189|NCT01580293|OG003|Outcome|BAY94-9027 Prophylaxis Treatment, Every 7 Days, Main Trial|All participants started BAY94-9027 IV infusion with 2x/week at a dose of 25 IU/kg for 10 weeks. Participants <2 spontaneous joint and/or muscle bleeds were randomized 1:1 to either every 5 or every 7 days dosing regimen, participants randomized to the every 7 days treatment arm were to administer a dose of 60 IU/kg (maximum 6000 IU) every 7 days.
11099190|NCT01580293|OG004|Outcome|BAY94-9027 Prophylaxis Treatment Total, Main Trial|All participants receiving an schedule of prophylaxis treatment, all prophylaxis arms combined.
11099191|NCT01580293|OG000|Outcome|BAY949027 Treatment in Major Surgery, Part B|Participants who underwent major surgery received study drug during their hospital stay up to 3 weeks post surgery. Participants were treated according to the type of procedure, using tailored doses (a maximum of 60 IU/kg/infusion) expected to maintain acceptable therapeutic level of FVIII activity.
11099192|NCT01580293|OG000|Outcome|BAY94-9027 Treatment - Part A, Week 0|Part A, Week 0 included all PKS participants treated with a single (first) dose of BAY94-9027 as an IV infusion at Week 0.
11099193|NCT01580293|OG001|Outcome|BAY94-9027 Treatment - Part A, Week 36|Part A, Week 36 group included all PKS participants treated with multiple doses (last dose paired) of BAY94-9027 as an IV infusion at Week 36. Paired data were defined as the single dose data for the sub-set of participants who also had multiple dose PK data.
11099194|NCT01580293|OG001|Outcome|BAY94-9027 Prophylaxis Treatment Total, Main Trial|All participants receiving an schedule of prophylaxis treatment, all prophylaxis arms combined.
11099195|NCT01580293|OG000|Outcome|BAY94-9027 Treatment - Part A|This group included both on-demand and prophylaxis arms in Part A.
11099196|NCT01580293|EG000|Reported Event|BAY94-9027 Treatment, Part A, Main Trial|Subjects entering Part A main trial were treated with BAY 94-9027 for either on-demand or prophylactic treatment.
11099197|NCT01580293|EG001|Reported Event|BAY94-9027 Treatment, Part A, Extension|Subjects in Part A extension either continued their regimen from main trial or switched to one of the other regimens at any time.
11099198|NCT01580293|EG002|Reported Event|BAY94-9027 Treatment in Major Surgery, Part B|Subjects, either Part B subjects only or subjects from Part A/Part A Extension, who underwent major surgery received study drug during their hospital stay up to 3 weeks post-surgery. Subjects were treated according to the type of procedure, using tailored doses (a maximum of 60 IU/kg/infusion) expected to maintain acceptable therapeutic level of FVIII activity.
11099199|NCT01580306|BG000|Baseline|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
11099200|NCT01580306|BG001|Baseline|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
11099201|NCT01580306|BG002|Baseline|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
11099202|NCT01580306|BG003|Baseline|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
11099203|NCT01580306|BG004|Baseline|Total|Total of all reporting groups
11099204|NCT01580306|FG000|Participant Flow|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
11099205|NCT01580306|FG001|Participant Flow|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
11099206|NCT01580306|FG002|Participant Flow|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
11099207|NCT01580306|FG003|Participant Flow|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
11099208|NCT01580306|OG000|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
11099209|NCT01580306|OG001|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
11099210|NCT01580306|OG002|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
11099211|NCT01580306|OG003|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
11099212|NCT01580306|EG000|Reported Event|BI 201335 Relevant Treatment Dose (Normal Renal Function)|"Capsule for oral administration~estimated glomerular filtration rate >= 90 mL/min/1.73m2"
11099213|NCT01580306|EG001|Reported Event|BI 201335 Relevant Treatment Dose (Mild Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 60-89 mL/min/1.73m2"
11099214|NCT01580306|EG002|Reported Event|BI 201335 Relevant Treatment Dose (Moderate Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 30-59 mL/min/1.73m2"
11099215|NCT01580306|EG003|Reported Event|BI 201335 Relevant Treatment Dose (Severe Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 15-29 mL/min/1.73m2"
11099216|NCT01580410|BG000|Baseline|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
11099217|NCT01580410|BG001|Baseline|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
11099218|NCT01580410|BG002|Baseline|Total|Total of all reporting groups
11099219|NCT01580410|FG000|Participant Flow|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
11099220|NCT01580410|FG001|Participant Flow|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
11099221|NCT01580410|OG000|Outcome|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
11099222|NCT01580410|OG001|Outcome|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
11099223|NCT01580410|EG000|Reported Event|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
11099224|NCT01580410|EG001|Reported Event|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
11099225|NCT01580423|BG000|Baseline|Entire Study Population|Includes groups randomized to receive aprepitant first and inert powder first.
11099226|NCT01580423|FG000|Participant Flow|First Aprepitant, Then Inert Powder|Capsule of aprepitant 125 mg in first intervention period and capsule of inert powder in second intervention period.
11099227|NCT01580423|FG001|Participant Flow|First Inert Powder, Then Aprepitant|Capsule of inert powder in first intervention period and capsule of aprepitant 125 mg in second intervention period.
11099228|NCT01580423|OG000|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
11099229|NCT01580423|OG001|Outcome|Inert Powder|Capsule containing inert powder
11099230|NCT01580423|OG001|Outcome|Inert Powder|Capsule containing insert powder
11099231|NCT01580423|EG000|Reported Event|Aprepitant|Capsule filled with 125 mg of aprepitant
11099232|NCT01580423|EG001|Reported Event|Inert Powder|Capsule filled with inert powder
11099233|NCT01580488|BG000|Baseline|All Study Participants|
11099234|NCT01580488|FG000|Participant Flow|All Study Participants|"Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation B containing 20 mg/g LEO 35299 Topical cream formulation C containing 20 mg/g LEO 35299 Topical solution formulation E containing 10 mg/g LEO 35299 Topical solution formulation F containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle"
11099235|NCT01580488|OG000|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
11099236|NCT01580488|OG001|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
11099237|NCT01580488|OG002|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
11099238|NCT01580488|OG003|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
11099239|NCT01580488|OG004|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
11099240|NCT01580488|OG005|Outcome|Daivonex® Ointment|Topical ointment vehicle
11099241|NCT01580488|EG000|Reported Event|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
11099242|NCT01580488|EG001|Reported Event|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
11099243|NCT01580488|EG002|Reported Event|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
11099244|NCT01580488|EG003|Reported Event|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
11099245|NCT01580488|EG004|Reported Event|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
11099246|NCT01580488|EG005|Reported Event|Daivonex® Ointment|Topical ointment vehicle
11099247|NCT01580592|BG000|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
11099248|NCT01580592|BG001|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
11099249|NCT01580592|BG002|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
11099250|NCT01580592|BG003|Baseline|Total|Total of all reporting groups
11099251|NCT01580592|FG000|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
11099252|NCT01580592|FG001|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
11099253|NCT01580592|FG002|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
11099254|NCT01580592|OG000|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
11099255|NCT01580592|OG001|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
11099256|NCT01580592|OG002|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
11099257|NCT01580592|EG000|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
11099258|NCT01580592|EG001|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
11099259|NCT01580592|EG002|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
11099260|NCT01580618|BG000|Baseline|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
11099261|NCT01580618|BG001|Baseline|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
11099262|NCT01580618|BG002|Baseline|Total|Total of all reporting groups
11099263|NCT01580618|FG000|Participant Flow|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
11099264|NCT01580618|FG001|Participant Flow|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
11099265|NCT01580618|OG000|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
11099266|NCT01580618|OG001|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
11099267|NCT01580618|EG000|Reported Event|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
11099268|NCT01580618|EG001|Reported Event|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
11099269|NCT01580670|BG000|Baseline|TA-650|"This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.~TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.~For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.~If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg."
11099270|NCT01580670|FG000|Participant Flow|TA-650|"This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.~TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.~For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.~If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg."
11099271|NCT01580670|OG000|Outcome|TA-650|"This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.~TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.~For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.~If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg."
11099272|NCT01580670|EG000|Reported Event|TA-650|"This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.~TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.~For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.~If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg."
11099273|NCT01580904|BG000|Baseline|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
11099274|NCT01580904|BG001|Baseline|Control Group|Patients will not be followed by the pharmacist.
11099275|NCT01580904|BG002|Baseline|Total|Total of all reporting groups
11099276|NCT01580904|FG000|Participant Flow|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
11099277|NCT01580904|FG001|Participant Flow|Control Group|Patients will not be followed by the pharmacist.
11099278|NCT01580904|OG000|Outcome|Control Group|Patients will not be followed by the pharmacist.
11099279|NCT01580904|OG001|Outcome|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
11099280|NCT01580904|OG001|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
11099281|NCT01580904|EG000|Reported Event|Control Group|Patients will not be followed by the pharmacist.
11099282|NCT01580904|EG001|Reported Event|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
11099283|NCT01580969|BG000|Baseline|Dose Level 0: 100 mg Bid|Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
11099284|NCT01580969|BG001|Baseline|Dose Level 1: 200 mg Bid|Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
11099285|NCT01580969|BG002|Baseline|Dose Level 2: 400 mg Bid|Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
11099286|NCT01580969|BG003|Baseline|Total|Total of all reporting groups
11099287|NCT01580969|FG000|Participant Flow|Dose Level 0: 100 mg Bid|Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
11099288|NCT01580969|FG001|Participant Flow|Dose Level 1: 200 mg Bid|Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
11099289|NCT01580969|FG002|Participant Flow|Dose Level 2: 400 mg Bid|Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
11099290|NCT01580969|OG000|Outcome|Dose Level 0: 100 mg Bid|Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
11099291|NCT01580969|OG001|Outcome|Dose Level 1: 200 mg Bid|Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
11099292|NCT01580969|OG002|Outcome|Dose Level 2: 400 mg Bid|Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
11099293|NCT01580969|EG000|Reported Event|Dose Level 0: 100 mg Bid|Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
11099294|NCT01580969|EG001|Reported Event|Dose Level 1: 200 mg Bid|Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
11099295|NCT01580969|EG002|Reported Event|Dose Level 2: 400 mg Bid|Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
11099296|NCT01580995|BG000|Baseline|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
11003774|NCT01074008|FG008|Participant Flow|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003775|NCT01074008|OG000|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003776|NCT01074008|OG001|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003777|NCT01074008|OG002|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003778|NCT01074008|OG003|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003779|NCT01074008|OG004|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003780|NCT01074008|OG005|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003781|NCT01074008|OG006|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003782|NCT01074008|OG007|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003783|NCT01074008|OG008|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003784|NCT01074008|OG000|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003785|NCT01074008|OG001|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003786|NCT01074008|OG002|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003787|NCT01074008|OG000|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003788|NCT01074008|OG001|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003789|NCT01074008|OG000|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11099297|NCT01580995|BG001|Baseline|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
11003790|NCT01074008|OG001|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003791|NCT01074008|OG002|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003792|NCT01074008|OG003|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003793|NCT01074008|EG000|Reported Event|ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003794|NCT01074008|EG001|Reported Event|ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003795|NCT01074008|EG002|Reported Event|ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003796|NCT01074008|EG003|Reported Event|ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003797|NCT01074008|EG004|Reported Event|ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003798|NCT01074008|EG005|Reported Event|ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003799|NCT01074008|EG006|Reported Event|ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003800|NCT01074008|EG007|Reported Event|ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003801|NCT01074008|EG008|Reported Event|Placebo + (pegIFN/RBV)|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
11003802|NCT01074034|BG000|Baseline|AV Therapy Assessment Group|"AV Therapy Assessment group, Atrial ATP and Atrial Therapy Suite (ATS)~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device~Ventricular tachyarrhythmia rescue shock feature~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device"
11003803|NCT01074034|FG000|Participant Flow|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
11003804|NCT01074034|OG000|Outcome|AV Therapy Assessment Group|"appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device"
11003805|NCT01074034|OG000|Outcome|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
11003806|NCT01074034|EG000|Reported Event|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
11003807|NCT01074047|BG000|Baseline|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
11099298|NCT01580995|BG002|Baseline|Total|Total of all reporting groups
11099299|NCT01580995|FG000|Participant Flow|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
11099300|NCT01580995|FG001|Participant Flow|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
11099301|NCT01580995|OG000|Outcome|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
11099302|NCT01580995|OG001|Outcome|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
11099303|NCT01580995|EG000|Reported Event|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
11099304|NCT01580995|EG001|Reported Event|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
11099305|NCT01581008|BG000|Baseline|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
11099306|NCT01581008|BG001|Baseline|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
11099307|NCT01581008|BG002|Baseline|Total|Total of all reporting groups
11099308|NCT01581008|FG000|Participant Flow|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
11099309|NCT01581008|FG001|Participant Flow|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
11099310|NCT01581008|OG000|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
11099311|NCT01581008|OG001|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
11099312|NCT01581008|OG000|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
11099313|NCT01581008|EG000|Reported Event|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
11099314|NCT01581008|EG001|Reported Event|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
11099315|NCT01581021|BG000|Baseline|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
11099316|NCT01581021|BG001|Baseline|Laminar Hooks|Group treated with hooks in the thoracic spine
11099317|NCT01581021|BG002|Baseline|Total|Total of all reporting groups
11099318|NCT01581021|FG000|Participant Flow|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
11099319|NCT01581021|FG001|Participant Flow|Laminar Hooks|Group treated with hooks in the thoracic spine
11099320|NCT01581021|OG000|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
11099321|NCT01581021|OG001|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
11099322|NCT01581021|EG000|Reported Event|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
11099323|NCT01581021|EG001|Reported Event|Laminar Hooks|Group treated with hooks in the thoracic spine
11099324|NCT01581281|BG000|Baseline|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
11099325|NCT01581281|BG001|Baseline|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
11099326|NCT01581281|BG002|Baseline|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
11099327|NCT01581281|BG003|Baseline|Total|Total of all reporting groups
11099328|NCT01581281|FG000|Participant Flow|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
11099329|NCT01581281|FG001|Participant Flow|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
11099330|NCT01581281|FG002|Participant Flow|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
11099331|NCT01581281|OG000|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved
11099332|NCT01581281|OG001|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
11099333|NCT01581281|OG002|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
11099334|NCT01581281|OG000|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
11099335|NCT01581281|EG000|Reported Event|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
11099336|NCT01581281|EG001|Reported Event|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
11099337|NCT01581281|EG002|Reported Event|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
11099338|NCT01581307|BG000|Baseline|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
11099339|NCT01581307|FG000|Participant Flow|2nd Line Chemotherapy With Radiotherapy|"Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy is given every two weeks for 6-10 cycles.~The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.~FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin): The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.~TheraSpheres: TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors."
11099340|NCT01581307|OG000|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
11099341|NCT01581307|EG000|Reported Event|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
11099342|NCT01581437|BG000|Baseline|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
11099343|NCT01581437|FG000|Participant Flow|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
11099344|NCT01581437|OG000|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
11099345|NCT01581437|OG000|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.~Outcome:78 patients enrolled multicenter."
11099346|NCT01581437|OG000|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.~Outcome:78 patients enrolled multicenter"
11099347|NCT01581437|OG000|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: Outcome:78 patients enrolled multicenter"
11099348|NCT01581437|OG000|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter:"
11099349|NCT01581437|EG000|Reported Event|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
11099350|NCT01581541|BG000|Baseline|PU-H71|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099351|NCT01581541|FG000|Participant Flow|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099352|NCT01581541|FG001|Participant Flow|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099353|NCT01581541|FG002|Participant Flow|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099354|NCT01581541|FG003|Participant Flow|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099355|NCT01581541|FG004|Participant Flow|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099356|NCT01581541|FG005|Participant Flow|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099357|NCT01581541|FG006|Participant Flow|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099358|NCT01581541|FG007|Participant Flow|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099359|NCT01581541|FG008|Participant Flow|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099360|NCT01581541|FG009|Participant Flow|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099361|NCT01581541|FG010|Participant Flow|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099362|NCT01581541|OG000|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099363|NCT01581541|OG001|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099364|NCT01581541|OG002|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099365|NCT01581541|OG003|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099366|NCT01581541|OG004|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099367|NCT01581541|OG005|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099368|NCT01581541|OG006|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099369|NCT01581541|OG007|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099370|NCT01581541|OG008|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099371|NCT01581541|OG009|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099372|NCT01581541|OG010|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099373|NCT01581541|OG000|Outcome|PU-H71|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099374|NCT01581541|EG000|Reported Event|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099375|NCT01581541|EG001|Reported Event|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099376|NCT01581541|EG002|Reported Event|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099377|NCT01581541|EG003|Reported Event|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099378|NCT01581541|EG004|Reported Event|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
10845981|NCT00271739|EG000|Reported Event|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
11099379|NCT01581541|EG005|Reported Event|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099380|NCT01581541|EG006|Reported Event|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099381|NCT01581541|EG007|Reported Event|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099382|NCT01581541|EG008|Reported Event|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099383|NCT01581541|EG009|Reported Event|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099384|NCT01581541|EG010|Reported Event|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
11099385|NCT01581593|BG000|Baseline|Kedrion IVIG 10% 21 and 28 Day Infusion Schedule|"Kedrion IVIG 10% 21 and 28 Day infusion schedule~Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Treatment duration - 12 months"
11099386|NCT01581593|FG000|Participant Flow|Kedrion IVIG 10% 21 and 28 Days Infusion Schedule|"Kedrion IVIG 10% treatment 21 and 28-day infusion schedule~Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months"
11099387|NCT01581593|OG000|Outcome|Kedrion IVIG 10% 21 and 28 Days Infusion Schedule|"Kedrion IVIG 10% treatment 21 and 28-day infusion schedule~Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months"
11099388|NCT01581593|OG000|Outcome|Kedrion IVIG 10% 21 and 28 Days Infusion Schedule|"Kedrion IVIG 10% treatment 21 and 28-day infusion schedule~Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Treatment duration - 12 months"
11099389|NCT01581593|OG000|Outcome|Kedrion IVIG 10% 21 & 28 Days Treatment Schedule|"Kedrion IVIG 10% treatment.~Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months"
11099390|NCT01581593|OG000|Outcome|Kedrion IVIG 10% 21 & 28 Days Treatments Schedule|"Kedrion IVIG 10% treatment.~Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months"
11099391|NCT01581593|OG000|Outcome|Kedrion IVIG 10% 21 and 28 Days Treatment Schedule|"Kedrion IVIG 10% treatment.~Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months"
11099392|NCT01581593|EG000|Reported Event|Kedrion IVIG 10%|"Kedrion IVIG 10% treatment.~Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Duration - 12 months"
11099393|NCT01581619|BG000|Baseline|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
11099394|NCT01581619|FG000|Participant Flow|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
11099395|NCT01581619|OG000|Outcome|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
11099396|NCT01581619|OG000|Outcome|Partial Breast Irradiation - DCIS Only|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks~Participants with DCIS only"
11099397|NCT01581619|OG001|Outcome|Partial Breast Irradiation - Invasive Cancer|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks~Participants with Invasive breast cancer"
11099398|NCT01581619|EG000|Reported Event|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
11099399|NCT01581658|BG000|Baseline|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
11099400|NCT01581658|BG001|Baseline|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
11099401|NCT01581658|BG002|Baseline|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
11099402|NCT01581658|BG003|Baseline|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
11099403|NCT01581658|BG004|Baseline|Total|Total of all reporting groups
11099404|NCT01581658|FG000|Participant Flow|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
11099405|NCT01581658|FG001|Participant Flow|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
11099406|NCT01581658|FG002|Participant Flow|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
11099407|NCT01581658|FG003|Participant Flow|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
11099408|NCT01581658|OG000|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
11099409|NCT01581658|OG001|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
11099410|NCT01581658|OG002|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
11099411|NCT01581658|OG003|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
11099412|NCT01581658|EG000|Reported Event|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
11099413|NCT01581658|EG001|Reported Event|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
11099414|NCT01581658|EG002|Reported Event|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
11099415|NCT01581658|EG003|Reported Event|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
11099416|NCT01581684|BG000|Baseline|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
11099417|NCT01581684|BG001|Baseline|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
11099418|NCT01581684|BG002|Baseline|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
11099419|NCT01581684|BG003|Baseline|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
11099420|NCT01581684|BG004|Baseline|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
11099421|NCT01581684|BG005|Baseline|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
11099422|NCT01581684|BG006|Baseline|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
11099423|NCT01581684|BG007|Baseline|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
11099424|NCT01581684|BG008|Baseline|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
11099425|NCT01581684|BG009|Baseline|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
11099426|NCT01581684|BG010|Baseline|Total|Total of all reporting groups
11099427|NCT01581684|FG000|Participant Flow|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
11099428|NCT01581684|FG001|Participant Flow|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
11099429|NCT01581684|FG002|Participant Flow|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
11099430|NCT01581684|FG003|Participant Flow|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
11099431|NCT01581684|FG004|Participant Flow|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
11099432|NCT01581684|FG005|Participant Flow|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
11099433|NCT01581684|FG006|Participant Flow|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
11099434|NCT01581684|FG007|Participant Flow|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
11099435|NCT01581684|FG008|Participant Flow|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
11099436|NCT01581684|FG009|Participant Flow|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
11099437|NCT01581684|OG000|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
11099438|NCT01581684|OG001|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
11099439|NCT01581684|OG002|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
11099440|NCT01581684|OG003|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
11099441|NCT01581684|OG004|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
11099442|NCT01581684|OG005|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
11099443|NCT01581684|OG006|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
11099444|NCT01581684|OG007|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
11099445|NCT01581684|OG008|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
11099446|NCT01581684|OG000|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
11099447|NCT01581684|OG001|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
11099448|NCT01581684|OG002|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
11099449|NCT01581684|OG003|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
11099450|NCT01581684|OG004|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
11099451|NCT01581684|OG005|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
11099452|NCT01581684|OG006|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
11099453|NCT01581684|OG007|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
11099454|NCT01581684|OG008|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
11099455|NCT01581684|OG009|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
11099456|NCT01581684|OG010|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
11099457|NCT01581684|EG000|Reported Event|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
11099458|NCT01581684|EG001|Reported Event|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
11099459|NCT01581684|EG002|Reported Event|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
11099460|NCT01581684|EG003|Reported Event|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
11099461|NCT01581684|EG004|Reported Event|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
11099462|NCT01581684|EG005|Reported Event|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
11099463|NCT01581684|EG006|Reported Event|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
11099464|NCT01581684|EG007|Reported Event|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
11099465|NCT01581684|EG008|Reported Event|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
11099466|NCT01581684|EG009|Reported Event|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
11099467|NCT01581684|EG010|Reported Event|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
11099468|NCT01581710|BG000|Baseline|Subjects|All subjects
11099469|NCT01581710|FG000|Participant Flow|Montelukast to Placebo|Montelukast to placebo: Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
11099470|NCT01581710|FG001|Participant Flow|Placebo to Montelukast|Placebo to montelukast: Subjects will receive matching placebo. Each treatment period consists of 2 weeks
11099471|NCT01581710|OG000|Outcome|Baseline Lung Function|Before placebo or montelukast administration
11099472|NCT01581710|OG001|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
11099473|NCT01581710|OG002|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
11099474|NCT01581710|OG000|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
11099475|NCT01581710|OG001|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
11099476|NCT01581710|EG000|Reported Event|Baseline Lung Function|Before placebo or montelukast administration
11099477|NCT01581710|EG001|Reported Event|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
11099478|NCT01581710|EG002|Reported Event|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
11099479|NCT01581931|BG000|Baseline|Overall Study|This was an open-label, randomised, single dose, 2-way crossover trial with 2 treatments and 2 treatment sequences. The single dose administrations in each treatment period were separated by a washout period of at least 35 days.
11099480|NCT01581931|FG000|Participant Flow|Lina+Met Single Tablets / Lina+Met FDC Tablet|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in the first period. After a washout period of at least 35 days, the subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in period 2.
11099481|NCT01581931|FG001|Participant Flow|Lina+Met FDC Tablet / Lina+Met Single Tablets|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in the first period. After a washout period of at least 35 days, the subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in period 2.
11099482|NCT01581931|OG000|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
11099483|NCT01581931|OG001|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
11099484|NCT01581931|EG000|Reported Event|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
11099485|NCT01581931|EG001|Reported Event|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
11099486|NCT01581970|BG000|Baseline|Cetuximab/Low Dose Cyclophosphamide|"Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.~Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.~Cetuximab: The initial dose of cetuximab 400 mg/m^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m^2 intravenously (IV) over 60 minutes."
11099487|NCT01581970|FG000|Participant Flow|Cetuximab/Low Dose Cyclophosphamide|"Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.~Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.~Cetuximab: The initial dose of cetuximab 400 mg/m^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m^2 intravenously (IV) over 60 minutes."
11099488|NCT01581970|OG000|Outcome|Cetuximab/Low Dose Cyclophosphamide|"Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.~Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.~Cetuximab: The initial dose of cetuximab 400 mg/m^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m^2 intravenously (IV) over 60 minutes."
11099489|NCT01581970|EG000|Reported Event|Cetuximab/Low Dose Cyclophosphamide|"Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.~Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.~Cetuximab: The initial dose of cetuximab 400 mg/m^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m^2 intravenously (IV) over 60 minutes."
11099490|NCT01582009|BG000|Baseline|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
11099491|NCT01582009|FG000|Participant Flow|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
11099492|NCT01582009|OG000|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
11099493|NCT01582009|EG000|Reported Event|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
11099494|NCT01582061|BG000|Baseline|Pasireotide 600 μg|Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
11099495|NCT01582061|BG001|Baseline|Pasireotide 900 μg|Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
11099496|NCT01582061|BG002|Baseline|Total|Total of all reporting groups
11099497|NCT01582061|FG000|Participant Flow|Pasireotide 600 μg|Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
11099498|NCT01582061|FG001|Participant Flow|Pasireotide 900 μg|Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
11099499|NCT01582061|OG000|Outcome|600 µg Bid - All Grades|All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
11099500|NCT01582061|OG001|Outcome|600 μg - Grades 3/4|Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients
11099501|NCT01582061|OG002|Outcome|900 μg - All Grades|All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
11099502|NCT01582061|OG003|Outcome|900 μg - Grades 3/4|Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg
11099503|NCT01582061|OG004|Outcome|All Patients - All Grades|All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
11099504|NCT01582061|OG005|Outcome|All Patients - Grades 3/4|All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
11099505|NCT01582061|OG000|Outcome|Pasireotide 600 μg|Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
11099506|NCT01582061|OG001|Outcome|Pasireotide 900 μg|Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
11099507|NCT01582061|OG002|Outcome|All Patients|Patients received pasireotide 600 μg or 900 μg BID
11099508|NCT01582061|OG001|Outcome|900 μg - All Grades|All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
11099509|NCT01582061|OG002|Outcome|All Patients - All Grades|All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
11099510|NCT01582061|EG000|Reported Event|600 µg Bid|600 µg bid
11099511|NCT01582061|EG001|Reported Event|900 µg Bid|900 µg bid
11099512|NCT01582061|EG002|Reported Event|All Patients|All patients
11099513|NCT01582139|BG000|Baseline|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
11099514|NCT01582139|BG001|Baseline|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
11099515|NCT01582139|BG002|Baseline|Total|Total of all reporting groups
11099516|NCT01582139|FG000|Participant Flow|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
11099517|NCT01582139|FG001|Participant Flow|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
11099518|NCT01582139|OG000|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
11099519|NCT01582139|OG001|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
11099520|NCT01582139|EG000|Reported Event|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
11099521|NCT01582139|EG001|Reported Event|Experimental: Heart Rate Informed SSM+HMM|"Experimental:~An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
11099522|NCT01582152|BG000|Baseline|TPI 287 160 mg/m2 + Bevacizumab|TPI287 160 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
11099523|NCT01582152|BG001|Baseline|TPI 287 140 mg/m2 + Bevacizumab|TPI287 140 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
11099524|NCT01582152|BG002|Baseline|Total|Total of all reporting groups
11099525|NCT01582152|FG000|Participant Flow|TPI 287 160 mg/m2 + Bevacizumab|TPI287 160 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
11099526|NCT01582152|FG001|Participant Flow|TPI 287 140 mg/m2 + Bevacizumab|TPI287 140 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
11099527|NCT01582152|OG000|Outcome|TPI 287 160 mg/m2 + Bevacizumab|TPI287 160 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
11099528|NCT01582152|OG001|Outcome|TPI 287 140 mg/m2 + Bevacizumab|TPI287 140 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
11099529|NCT01582152|EG000|Reported Event|TPI 287 160 mg/m2 + Bevacizumab|TPI287 160 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
11099530|NCT01582152|EG001|Reported Event|TPI 287 140 mg/m2 + Bevacizumab|TPI287 140 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
11099531|NCT01582178|BG000|Baseline|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11099532|NCT01582178|BG001|Baseline|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11099533|NCT01582178|BG002|Baseline|Total|Total of all reporting groups
11099534|NCT01582178|FG000|Participant Flow|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11099535|NCT01582178|FG001|Participant Flow|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11099536|NCT01582178|OG000|Outcome|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11099537|NCT01582178|OG001|Outcome|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11099538|NCT01582178|EG000|Reported Event|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11099539|NCT01582178|EG001|Reported Event|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11099540|NCT01582243|BG000|Baseline|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
11099541|NCT01582243|FG000|Participant Flow|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
11099542|NCT01582243|OG000|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
11099543|NCT01582243|EG000|Reported Event|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
11099544|NCT01582282|BG000|Baseline|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
11099545|NCT01582282|BG001|Baseline|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
11099546|NCT01582282|BG002|Baseline|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
11099547|NCT01582282|BG003|Baseline|Total|Total of all reporting groups
11099548|NCT01582282|FG000|Participant Flow|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
11099549|NCT01582282|FG001|Participant Flow|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
11099550|NCT01582282|FG002|Participant Flow|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
11099551|NCT01582282|OG000|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
11099552|NCT01582282|OG001|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
11099553|NCT01582282|OG002|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
11099554|NCT01582282|EG000|Reported Event|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
11099555|NCT01582282|EG001|Reported Event|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
11099556|NCT01582282|EG002|Reported Event|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
11099557|NCT01582308|BG000|Baseline|All Enrolled Participants|
11099558|NCT01582308|FG000|Participant Flow|Treatment Sequence 1|Sitagliptin 100 mg in Period 1 followed by saxagliptin 5 mg in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg in Period 5
11099559|NCT01582308|FG001|Participant Flow|Treatment Sequence 2|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by placebo in Period 3 followed by sitagliptin 100 mg in Period 4 followed by vildagliptin 50 mg BID in Period 5
11099560|NCT01582308|FG002|Participant Flow|Treatment Sequence 3|Vildagliptin 50 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by sitagliptin 100 mg in Period 3 followed by saxagliptin 5 mg in Period 4 followed by placebo in Period 5
11099561|NCT01582308|FG003|Participant Flow|Treatment Sequence 4|Vildagliptin 50 mg BID in Period 1 followed by placebo in Period 2 followed by saxagliptin 5 mg in Period 3 followed by vildagliptin 50 mg in Period 4 followed by sitagliptin 100 mg in Period 5
11099562|NCT01582308|FG004|Participant Flow|Treatment Sequence 5|Placebo in Period 1 followed by sitagliptin 100 mg in Period 2 followed by vildagliptin 50 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by saxagliptin 5 mg in Period 5
11099563|NCT01582308|FG005|Participant Flow|Treatment Sequence 6|Sitagliptin 100 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by saxagliptin 5 mg in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg BID in Period 5
11099564|NCT01582308|FG006|Participant Flow|Treatment Sequence 7|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by vildagliptin 50 mg in Period 3 followed by sitagliptin 100 mg in Period 4 followed by placebo in Period 5
11099565|NCT01582308|FG007|Participant Flow|Treatment Sequence 8|Vildagliptin 50 mg in Period 1 followed by placebo in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by saxagliptin 5 mg in Period 4 followed by sitagliptin 100 mg in Period 5
11099566|NCT01582308|FG008|Participant Flow|Treatment Sequence 9|Vildagliptin 50 mg BID in Period 1 followed by sitagliptin 100 mg in Period 2 followed by placebo in Period 3 followed by vildagliptin 50 mg in Period 4 followed by saxagliptin 5 mg in Period 5
11099567|NCT01582308|FG009|Participant Flow|Treatment Sequence 10|Placebo in Period 1 followed by saxagliptin 5 mg in Period 2 followed by sitagliptin 100 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by vildagliptin 50 mg in Period 5
11099568|NCT01582308|OG000|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
11099569|NCT01582308|OG001|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
11099570|NCT01582308|OG002|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
11099571|NCT01582308|OG003|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
11099572|NCT01582308|OG004|Outcome|Placebo|Placebo to sitagliptin daily for 5 days
11099573|NCT01582308|OG000|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
11099574|NCT01582308|EG000|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
11099575|NCT01582308|EG001|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
11099576|NCT01582308|EG002|Reported Event|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
11099577|NCT01582308|EG003|Reported Event|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
11099578|NCT01582308|EG004|Reported Event|Placebo|Placebo to sitagliptin daily for 5 days
11099579|NCT01582451|BG000|Baseline|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
11099580|NCT01582451|BG001|Baseline|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
11099581|NCT01582451|BG002|Baseline|Total|Total of all reporting groups
11099582|NCT01582451|FG000|Participant Flow|LY2605541|LY2605541 was administered by subcutaneous (SQ) injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG).
11099583|NCT01582451|FG001|Participant Flow|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
11099584|NCT01582451|OG000|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
11099585|NCT01582451|OG001|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
11099586|NCT01582451|EG000|Reported Event|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
11099587|NCT01582451|EG001|Reported Event|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
11099588|NCT01582477|BG000|Baseline|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
11099589|NCT01582477|BG001|Baseline|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
11099590|NCT01582477|BG002|Baseline|Total|Total of all reporting groups
11099591|NCT01582477|FG000|Participant Flow|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
11099592|NCT01582477|FG001|Participant Flow|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
11099593|NCT01582477|OG000|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
11099594|NCT01582477|OG001|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
11099595|NCT01582477|EG000|Reported Event|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
11099596|NCT01582477|EG001|Reported Event|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
11099597|NCT01582490|BG000|Baseline|Infiltration - EXPAREL|"Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery.~Instillation - EXPAREL: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
11099598|NCT01582490|BG001|Baseline|Instillation - EXPAREL|"Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.~Infiltration - EXPAREL: IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
11099599|NCT01582490|BG002|Baseline|Total|Total of all reporting groups
11099600|NCT01582490|FG000|Participant Flow|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
11099601|NCT01582490|FG001|Participant Flow|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
11099602|NCT01582490|OG000|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
11099603|NCT01582490|OG001|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
11099604|NCT01582490|OG000|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
11099605|NCT01582490|OG001|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
11099606|NCT01582490|EG000|Reported Event|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
11099607|NCT01582490|EG001|Reported Event|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
11099608|NCT01582789|BG000|Baseline|Overall Study Group Prior to Dispense|All subjects prior to dispense of first set of study lenses
11099609|NCT01582789|FG000|Participant Flow|Enfilcon A, Then Senofilcon A|"Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
11099610|NCT01582789|FG001|Participant Flow|Senofilcon A, Then Enfilcon A|"Subjects were randomized to wear senofilcon A then enfilcon A for two weeks~senofilcon A: senofilcon A daily wear soft contact lens~enfilcon A: enfilcon A daily wear soft contact lens"
11099611|NCT01582789|OG000|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
11099612|NCT01582789|OG001|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
11099613|NCT01582789|OG000|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
11099614|NCT01582789|OG001|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
11099615|NCT01582789|EG000|Reported Event|Enfilcon A/Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
11099616|NCT01582789|EG001|Reported Event|Senofilcon A/Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
11099617|NCT01582854|BG000|Baseline|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
11099618|NCT01582854|BG001|Baseline|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
11099619|NCT01582854|BG002|Baseline|Total|Total of all reporting groups
11099620|NCT01582854|FG000|Participant Flow|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
11099621|NCT01582854|FG001|Participant Flow|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
11099622|NCT01582854|OG000|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
11099623|NCT01582854|OG001|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
11099624|NCT01582854|EG000|Reported Event|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
11099625|NCT01582854|EG001|Reported Event|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
11099626|NCT01582880|BG000|Baseline|Riboflavin Cross-linked Donor Cornea|"the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
11099627|NCT01582880|FG000|Participant Flow|Riboflavin Cross-linked Donor Cornea|"the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
11099628|NCT01582880|OG000|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
11099629|NCT01582880|EG000|Reported Event|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
11099630|NCT01582945|BG000|Baseline|Treatment-resistant Depression Patients|Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
11099631|NCT01582945|FG000|Participant Flow|Treatment-resistant Depression Patients|Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
11099632|NCT01582945|OG000|Outcome|Ketamine IV|"Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg over the course of 45 minutes, twice a week for 3 weeks. Participants received this dosage for the first three of six IV ketamine infusions. If participants do not experience an improvement of greater or equal to 30% in HAM-D scores after the first three infusions, the dose will be increased to 0.75mg/kg for the subsequent three infusions.~Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen"
11099633|NCT01582945|EG000|Reported Event|Ketamine IV|"Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks~Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen"
11099634|NCT01582971|BG000|Baseline|Intervention|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
11099635|NCT01582971|BG001|Baseline|Control|Standard medical care: no reflexology.
11099636|NCT01582971|BG002|Baseline|Total|Total of all reporting groups
11099637|NCT01582971|FG000|Participant Flow|Intervention|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
11099638|NCT01582971|FG001|Participant Flow|Control|Standard medical care: no reflexology.
11099639|NCT01582971|OG000|Outcome|Week 5 Intervention Group|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
11099640|NCT01582971|OG001|Outcome|Week 5 Control Group|Standard medical care: no reflexology
11099641|NCT01582971|OG002|Outcome|Week 11 Intervention Group|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
11099642|NCT01582971|OG003|Outcome|Week 11 Control Group|Standard medical care: no reflexology
11099643|NCT01582971|OG001|Outcome|Week 5 Control Group|Standard medical care: no reflexology.
11099644|NCT01582971|OG003|Outcome|Week 11 Control Group|Standard medical care: no reflexology.
11099645|NCT01582971|OG000|Outcome|Intervention|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
11099646|NCT01582971|OG001|Outcome|Control|Standard medical care: no reflexology.
11099647|NCT01582971|EG000|Reported Event|Intervention|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
11099648|NCT01582971|EG001|Reported Event|Control|Standard medical care: no reflexology
11099649|NCT01583101|BG000|Baseline|Receiving Highlighted Prompts|These patients received highlighted prompts.
11099650|NCT01583101|BG001|Baseline|Receiving Non-highlighted Prompts|These patients received prompts that were not highlighted.
11099651|NCT01583101|BG002|Baseline|Total|Total of all reporting groups
11099652|NCT01583101|FG000|Participant Flow|Highlighted Prompts|Physicians received highlighted prompts.
11099653|NCT01583101|FG001|Participant Flow|Non-highlighted Prompts|Physicians received prompts that were not highlighted.
11099654|NCT01583101|OG000|Outcome|Receiving Highlighted Prompts|Prompts received by physicians were highlighted.
11099655|NCT01583101|OG001|Outcome|Receiving Non-highlighted Prompts|Prompts received by physicians were not highlighted.
11099656|NCT01583101|EG000|Reported Event|Highlighted Prompts|These patients received highlighted prompts.
11099657|NCT01583101|EG001|Reported Event|Non-highlighted Prompts|These patients received prompts that were not highlighted.
11099658|NCT01583166|BG000|Baseline|Marcaine + Epinephrine|Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine
11099659|NCT01583166|BG001|Baseline|Saline + Epinephrine|Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
11099660|NCT01583166|BG002|Baseline|Total|Total of all reporting groups
11099661|NCT01583166|FG000|Participant Flow|Marcaine + Epinephrine|Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine
11099662|NCT01583166|FG001|Participant Flow|Saline + Epinephrine|Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
11099663|NCT01583166|OG000|Outcome|Marcaine + Epinephrine|Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine
11099664|NCT01583166|OG001|Outcome|Saline + Epinephrine|Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
11099665|NCT01583166|EG000|Reported Event|Marcaine + Epinephrine|Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine
11099666|NCT01583166|EG001|Reported Event|Saline + Epinephrine|Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
11099667|NCT01583179|BG000|Baseline|Control Group|will get only local anesthetic and epinephrine in block. no additive in block
11099668|NCT01583179|BG001|Baseline|Buprenorphine|"will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block~Buprenorphine: added to nerve block, 0.3mg one time peripheral block use"
11099669|NCT01583179|BG002|Baseline|Total|Total of all reporting groups
11099670|NCT01583179|FG000|Participant Flow|Control Group|will get only local anesthetic and epinephrine in block. no additive in block
11099671|NCT01583179|FG001|Participant Flow|Buprenorphine|"will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block~Buprenorphine: added to nerve block, 0.3mg one time peripheral block use"
11099672|NCT01583179|OG000|Outcome|Control Group|will get only local anesthetic and epinephrine in block. no additive in block
11099673|NCT01583179|OG001|Outcome|Buprenorphine|"will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block~Buprenorphine: added to nerve block, 0.3mg one time peripheral block use"
11099674|NCT01583179|EG000|Reported Event|Control Group|will get only local anesthetic and epinephrine in block. no additive in block
11099675|NCT01583179|EG001|Reported Event|Buprenorphine|"will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block~Buprenorphine: added to nerve block, 0.3mg one time peripheral block use"
11099676|NCT01583218|BG000|Baseline|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
11099677|NCT01583218|BG001|Baseline|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
11099678|NCT01583218|BG002|Baseline|Total|Total of all reporting groups
11099679|NCT01583218|FG000|Participant Flow|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
11099680|NCT01583218|FG001|Participant Flow|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
11099681|NCT01583218|OG000|Outcome|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
10878592|NCT00453336|FG000|Participant Flow|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
11099682|NCT01583218|OG001|Outcome|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
11099683|NCT01583218|EG000|Reported Event|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
11099684|NCT01583218|EG001|Reported Event|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
11126387|NCT01733069|OG000|Outcome|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
11126388|NCT01733069|OG001|Outcome|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
11126389|NCT01733069|EG000|Reported Event|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
11126390|NCT01733069|EG001|Reported Event|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
11126391|NCT01733121|BG000|Baseline|Placebo|Participants received Placebo capsule (matching valbenazine capsules) daily for 6 weeks.
10878593|NCT00453336|OG000|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
11126392|NCT01733121|BG001|Baseline|Valbenazine|Participants received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
11126393|NCT01733121|BG002|Baseline|Total|Total of all reporting groups
10878594|NCT00453336|EG000|Reported Event|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
11099685|NCT01583296|BG000|Baseline|CBT and HRVB|Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
11099686|NCT01583296|BG001|Baseline|Music Relaxation Therapy (MRT)|Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
11099687|NCT01583296|BG002|Baseline|Total|Total of all reporting groups
11099688|NCT01583296|FG000|Participant Flow|CBT and HRVB|"Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)~CBT and HRVB: cognitive behavioral therapy and heart rate variability biofeedback"
11099689|NCT01583296|FG001|Participant Flow|Music Relaxation Therapy (MRT)|"Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate~Music Relaxation Therapy (MRT): music relaxation therapy and breathing at resting respiration rate"
11099690|NCT01583296|OG000|Outcome|CBT and HRVB|Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
11099691|NCT01583296|OG001|Outcome|Music Relaxation Therapy (MRT)|Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
11099692|NCT01583296|EG000|Reported Event|CBT and HRVB|Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
11099693|NCT01583296|EG001|Reported Event|Music Relaxation Therapy (MRT)|Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
11099694|NCT01583374|BG000|Baseline|Placebo|Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
11099695|NCT01583374|BG001|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase continued to receive 20 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
11099696|NCT01583374|BG002|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
11099697|NCT01583374|BG003|Baseline|Total|Total of all reporting groups
11099698|NCT01583374|FG000|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
11099699|NCT01583374|FG001|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase continued to receive 20 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
11099700|NCT01583374|FG002|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
11099701|NCT01583374|FG003|Participant Flow|Placebo / Apremilast 30 mg Early Escape (EE)|Participants initially randomized to receive placebo tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the Assessment of SpondyloArthritis International Society (ASAS) domains at Week 16 were transitioned to 30 mg apremilast tablets BID and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
11099702|NCT01583374|FG004|Participant Flow|Placebo/Apremilast 30 mg Crossover (XO)|Participants initially randomized to placebo tablets BID in the 24-week placebo controlled phase were transitioned to 30 mg apremilast tablets BID at Week 24 and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
11099703|NCT01583374|FG005|Participant Flow|Apremilast 30 mg /Apremilast 30 mg EE|Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase who did not have at least 20% improvement or a ≥ 1-unit improvement from baseline in 2 of the 4 ASAS domains at Week 16 continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
11099704|NCT01583374|FG006|Participant Flow|Apremilast 20 mg /Apremilast 30 mg EE|Participants initially randomized to 20 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains at Week 16 were transitioned to 30 mg apremilast tablets BID and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
11126394|NCT01733121|FG000|Participant Flow|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
10878595|NCT00453349|BG000|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
11099705|NCT01583374|FG007|Participant Flow|Apremilast 30 mg /Apremilast 30 mg Second Escape (SE)|Participants initially randomized to 30 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains from baseline at Week 24 continued to receive 30 mg apremilast tablets BID (second escape) for up to 4.5 years in the long-term extension phase.
11099706|NCT01583374|FG008|Participant Flow|Apremilast 20 mg/Apremilast 30 mg SE|Participants initially randomized to 20 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains at Week 24 were transitioned to 30 mg apremilast tablets BID (second escape) and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
11099707|NCT01583374|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
11099708|NCT01583374|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
11099709|NCT01583374|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
11099710|NCT01583374|OG000|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, and continued to receive apremilast 20 mg or 30 mg during weeks 24 to 260.
11099711|NCT01583374|OG001|Outcome|Apremilast 30 mg|Participants initially randomized at Week 0 to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase, and continued to receive apremilast 30 mg during weeks 24 to 260.
11099712|NCT01583374|OG002|Outcome|Placebo/Apremilast 30 mg|Participants who initially received placebo tablets BID during the placebo controlled phase were transitioned to 30 mg apremilast tablets BID either at Week 16 or Week 24 through to Week 260.
11099713|NCT01583374|OG003|Outcome|Apremilast 20 mg/ Apremilast 30 mg|Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
11099714|NCT01583374|OG004|Outcome|Apremilast 20 mg/Apremilast 20 mg|Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
11099715|NCT01583374|OG000|Outcome|Apremilast 20 mg|Participants who received 20 mg apremilast tablets BID only in the study. This also includes participants who initially received APR 20 BID and switched to APR 30 BID treatment. Only the TEAEs that occurred during the 20 mg apremilast BID dose were included.
11099716|NCT01583374|OG001|Outcome|Apremilast 20/30 mg|Participants who initially received 20 mg apremilast tablets BID at Week 0 who escaped to 30 mg apremilast BID. Only the TEAEs that occurred during the apremilast 30 mg BID dose were included.
11099717|NCT01583374|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets BID at Week 0 and participants who received placebo at Week 0 who escaped to 30 mg apremilast BID. Only the TEAEs that occurred during the APR 30 mg BID dose were included.
11099718|NCT01583374|EG000|Reported Event|Placebo (Weeks 0-24) Placebo-Controlled Phase|Participants randomized to placebo tablets twice daily (BID) in the 24-week placebo-controlled phase.
11099719|NCT01583374|EG001|Reported Event|Apremilast 20 mg BID (Weeks 0-24) Placebo-Controlled Phase|Participants initially randomized to 20 mg apremilast tablets (APR) BID in the 24-week placebo-controlled phase.
11099720|NCT01583374|EG002|Reported Event|Apremilast 30 mg BID (Weeks 0-24) Placebo-Controlled Phase|Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
11099721|NCT01583374|EG003|Reported Event|Apremilast 20 mg BID (APR Exposure Period)|"Participants who received 20 mg apremilast tablets BID only in the study. This also includes participants who initially received APR 20 BID and switched to APR 30 BID treatment.~Only the TEAEs that occurred during the 20 mg apremilast BID dose were included."
11099722|NCT01583374|EG004|Reported Event|Apremilast 20/30 mg BID (APR Exposure Period)|Participants who initially received 20 mg apremilast tablets BID at Week 0 who escaped to 30 mg apremilast BID. Only the TEAEs that occurred during the 20 mg apremilast BID dose were included.
11099723|NCT01583374|EG005|Reported Event|Apremilast 30 mg BID (APR Exposure Period)|Participants initially randomized to 30 mg apremilast tablets BID at Week 0 and participants who received placebo at Week 0 who escaped to 30 mg apremilast tablets BID. Only the TEAEs that occurred during the 30 mg apremilast BID dose were included.
11099724|NCT01583452|BG000|Baseline|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
11099725|NCT01583452|BG001|Baseline|No Intervention|By observing the clinical evolution of the participants not given chewing gum as prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
11099726|NCT01583452|BG002|Baseline|Total|Total of all reporting groups
11099727|NCT01583452|FG000|Participant Flow|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
11099728|NCT01583452|FG001|Participant Flow|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
11099729|NCT01583452|OG000|Outcome|Chewing Gum Group|The time between the end of the surgery and the discharge of the patients, measured in hours.
11099730|NCT01583452|OG001|Outcome|Control Group|The time between the end of surgery and the discharge of the patient measured in hours.
11099731|NCT01583452|OG000|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
11099732|NCT01583452|OG001|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
11099733|NCT01583452|OG000|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
11099734|NCT01583452|EG000|Reported Event|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
11099735|NCT01583452|EG001|Reported Event|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
11099736|NCT01583530|BG000|Baseline|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
11099737|NCT01583530|BG001|Baseline|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
11099738|NCT01583530|BG002|Baseline|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
11099739|NCT01583530|BG003|Baseline|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
11099740|NCT01583530|BG004|Baseline|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
11099741|NCT01583530|BG005|Baseline|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
11099742|NCT01583530|BG006|Baseline|Total|Total of all reporting groups
11099743|NCT01583530|FG000|Participant Flow|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
11099744|NCT01583530|FG001|Participant Flow|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
11099745|NCT01583530|FG002|Participant Flow|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
11099746|NCT01583530|FG003|Participant Flow|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
11099747|NCT01583530|FG004|Participant Flow|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
11099748|NCT01583530|FG005|Participant Flow|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
11099749|NCT01583530|OG000|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
11099750|NCT01583530|OG001|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
11099751|NCT01583530|OG002|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
11099752|NCT01583530|OG003|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
11099753|NCT01583530|OG000|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
11099754|NCT01583530|OG001|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
11099755|NCT01583530|OG001|Outcome|Belimumab SC x 1 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
11099756|NCT01583530|OG004|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
11099757|NCT01583530|OG005|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
11099758|NCT01583530|EG000|Reported Event|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
11099759|NCT01583530|EG001|Reported Event|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
11099760|NCT01583530|EG002|Reported Event|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
11099761|NCT01583530|EG003|Reported Event|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
11099762|NCT01583530|EG004|Reported Event|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
11099763|NCT01583530|EG005|Reported Event|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
11099764|NCT01583543|BG000|Baseline|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
10845982|NCT00271739|EG001|Reported Event|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.
11099765|NCT01583543|FG000|Participant Flow|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
11099766|NCT01583543|OG000|Outcome|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
11099767|NCT01583543|OG000|Outcome|Olaparib|This group of patients with metastatic Ewing sarcoma received single agent olaparib.
11099768|NCT01583543|OG000|Outcome|Olaparib|This group of patients with metastatic Ewing sarcoma received single agent olaparib therapy.
11099769|NCT01583543|OG000|Outcome|Olaparib|"400mg PO BID Continuous~Olaparib: 400mg PO BID Continuous"
11099770|NCT01583543|EG000|Reported Event|Olaparib|400 mg PO BID Continuous Olaparib
11099771|NCT01583686|BG000|Baseline|Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099772|NCT01583686|BG001|Baseline|Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099773|NCT01583686|BG002|Baseline|Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099774|NCT01583686|BG003|Baseline|Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099775|NCT01583686|BG004|Baseline|Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099776|NCT01583686|BG005|Baseline|Total|Total of all reporting groups
11099777|NCT01583686|FG000|Participant Flow|Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099778|NCT01583686|FG001|Participant Flow|Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099779|NCT01583686|FG002|Participant Flow|Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099780|NCT01583686|FG003|Participant Flow|Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099781|NCT01583686|FG004|Participant Flow|Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099782|NCT01583686|OG000|Outcome|Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099783|NCT01583686|OG001|Outcome|Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099784|NCT01583686|OG002|Outcome|Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099785|NCT01583686|OG003|Outcome|Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099786|NCT01583686|OG004|Outcome|Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2|"1/Phase I:~Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099787|NCT01583686|OG000|Outcome|Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099788|NCT01583686|OG001|Outcome|Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
10845983|NCT00271856|BG000|Baseline|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
11099789|NCT01583686|OG002|Outcome|Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099790|NCT01583686|EG000|Reported Event|Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099791|NCT01583686|EG001|Reported Event|Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099792|NCT01583686|EG002|Reported Event|Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099793|NCT01583686|EG003|Reported Event|Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099794|NCT01583686|EG004|Reported Event|Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2|"1/Phase I:~Drug: Fludarabine~Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Other Names: •Fludara~Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)~Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.~Drug: Cyclophosphamide~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Other Names: •Cytoxan~Drug: Aldesleukin~Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Other Names: •Proleukin"
11099795|NCT01583868|BG000|Baseline|B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision|B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then PureVision2 for one week
11099796|NCT01583868|BG001|Baseline|B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis|B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then Ciba Vision for one week
11099797|NCT01583868|BG002|Baseline|Total|Total of all reporting groups
11099798|NCT01583868|FG000|Participant Flow|B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision|B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then PureVision2 for one week
11099799|NCT01583868|FG001|Participant Flow|B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis|B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then Ciba Vision for one week
11099800|NCT01583868|OG000|Outcome|B&L RD2135-01 Lens C|"Investigational Silicone hydrogel soft contact lens~B&L RD2135-01 lens C: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study."
11099801|NCT01583868|OG001|Outcome|B&L RD2135-01 Lens D|"Investigational Silicone hydrogel soft contact lens~B&L RD2135-01 lens D: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study."
11099802|NCT01583868|OG002|Outcome|PureVision2|"Bausch & Lomb High definition soft contact lenses~PureVision2: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study."
11099803|NCT01583868|OG003|Outcome|Ciba Vision Air Optix Aqua|"Ciba Vision Air Optix Aqua soft contact lens~Air Optix Aqua: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study."
11099804|NCT01583868|EG000|Reported Event|B&L RD2135-01 Lens C|B&L RD2135-01 Lens C
11099805|NCT01583868|EG001|Reported Event|B&L RD2135-01 Lens D|B&L RD2135-01 Lens D
11099806|NCT01583868|EG002|Reported Event|PureVision2|PureVision2
11099807|NCT01583868|EG003|Reported Event|Ciba Vision Air Optix Aqua|Ciba Vision Air Optix Aqua
11099808|NCT01583894|BG000|Baseline|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
11099809|NCT01583894|FG000|Participant Flow|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
11099810|NCT01583894|OG000|Outcome|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
11099811|NCT01583894|EG000|Reported Event|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
11099812|NCT01583985|BG000|Baseline|Opioid|The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
11099813|NCT01583985|BG001|Baseline|Non-opioid|The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
11099814|NCT01583985|BG002|Baseline|Total|Total of all reporting groups
11099815|NCT01583985|FG000|Participant Flow|Opioid|The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
11099816|NCT01583985|FG001|Participant Flow|Non-opioid|The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
11099817|NCT01583985|OG000|Outcome|Opioid|The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
11099818|NCT01583985|OG001|Outcome|Non-opioid|The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
11099819|NCT01583985|EG000|Reported Event|Opioid|The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
11099820|NCT01583985|EG001|Reported Event|Non-opioid|The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
11099821|NCT01584024|BG000|Baseline|Participants With Paired Lesions: Resin Infiltration / Control|Within-person study: both arms were applied in same participant (2 study teeth/lesions per person).
11099822|NCT01584024|FG000|Participant Flow|Participants With Paired Lesions: Resin Infiltration / Control|"Within-person study: both arms were applied in same participant (2 study teeth/lesions per person).~Resin infiltration (test) or Sham Treatment (control) of two paired carious lesions in addition to preventative measures and behavioral modification."
11099823|NCT01584024|OG000|Outcome|Resin Infiltration|Resin infiltration of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)
11099824|NCT01584024|OG001|Outcome|Control|Sham treatment of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)
11099825|NCT01584024|EG000|Reported Event|Participants With Paired Lesions: Resin Infiltration / Control|Within-person study: both arms were applied in same participant (2 study teeth/lesions per person).
11099826|NCT01584232|BG000|Baseline|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
11099827|NCT01584232|BG001|Baseline|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
11099828|NCT01584232|BG002|Baseline|Total|Total of all reporting groups
11099829|NCT01584232|FG000|Participant Flow|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
11099830|NCT01584232|FG001|Participant Flow|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
11099831|NCT01584232|OG000|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
11099832|NCT01584232|OG001|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
11099833|NCT01584232|EG000|Reported Event|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
11099834|NCT01584232|EG001|Reported Event|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
11099835|NCT01584388|BG000|Baseline|Rituximab|Rituximab: Rituximab 1000 mg IV times two doses, separated by approximately 15 days.
11099836|NCT01584388|FG000|Participant Flow|Rituximab|Rituximab: Rituximab 1000 mg IV times two doses, separated by approximately 15 days.
11099837|NCT01584388|OG000|Outcome|IgG4-RD Responder Index|Scoring at baseline
11099838|NCT01584388|OG001|Outcome|6 Months|IgG4-RD Responder Index 6 months after treatment
11099839|NCT01584388|OG000|Outcome|Glucocorticoid Treatment (Baseline)|total prednisone dose equivalent (mg) admin in the 28 preceding enrollment)
11099840|NCT01584388|OG001|Outcome|Glucocorticoid Use (6 Months)|total prednisone dose equivalent admin over 28 days prior to the 6 month study visit
11099841|NCT01584388|OG000|Outcome|Disease Flare|no disease flare before month 6
11099842|NCT01584388|OG000|Outcome|Relapse Treatment|Rituximab treatment for relapse
11099843|NCT01584388|OG000|Outcome|Disease Response at 6 Months|Decline of IgG4-RD RI by at least 2 points and maintained at 6 months.
11099844|NCT01584388|OG000|Outcome|Disease Response at 12 Months|Decline of IgG4-RD RI by at least 2 points and maintained at 12 months.
11099845|NCT01584388|OG000|Outcome|Complete Remission at 6 Months|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.
11099846|NCT01584388|OG000|Outcome|Complete Remission at 6 Months, Exclusive of Serum IgG4|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.
11099847|NCT01584388|OG000|Outcome|Complete Remission (Any Timepoint)|IgG4-RD RI = 0 at any point in the trial
11099848|NCT01584388|OG000|Outcome|Complete Remission at Any Timepoint, Exclusive of Serum IgG4|IgG4-RD RI = 0 (exclusive of serum IgG4) at any point in the trial
11099849|NCT01584388|OG000|Outcome|Time to Disease Response|Time to achievement of IgG4-RD RI improvement of > 2
11099850|NCT01584388|OG000|Outcome|Time to Relapse|Time to increase in IgG4-RD RI and reinstitution of treatment
11099851|NCT01584388|OG000|Outcome|Time to Complete Remission|Time to achievement of IgG4-RD RI of 0
11099852|NCT01584388|EG000|Reported Event|Open Label Treatment With Rituximab|Rituximab 1000 mg IV times two doses, separated by approximately 15 days
11099853|NCT01584440|BG000|Baseline|AVP-923|Participants received oral AVP-923 during Stage 1 for 5 consecutive weeks. Participants received AVP-923-20 once daily (QD) in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 1 (Days 1 to 7), AVP-923-20 twice a day (BID) during the next 2 consecutive weeks (Days 8 to 21), and AVP-923-30 BID during the final 2 weeks of Stage 1 (Days 22 to 35).
11099854|NCT01584440|BG001|Baseline|Placebo|Participants received matching oral placebo during Stage 1 for 5 consecutive weeks.
11099855|NCT01584440|BG002|Baseline|Total|Total of all reporting groups
11099856|NCT01584440|FG000|Participant Flow|Stage 1: AVP-923|"Participants received oral AVP-923 during Stage 1 for 5 consecutive weeks. Participants received AVP-923-20 once daily (QD) in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 1 (Days 1 to 7), AVP-923-20 twice a day (BID) during the next 2 consecutive weeks (Days 8 to 21), and AVP-923-30 BID during the final 2 weeks of Stage 1 (Days 22 to 35).~(AVP-923-20: 20 milligrams (mg) of dextromethorphan and 10 mg of quinidine; AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine)"
11099857|NCT01584440|FG001|Participant Flow|Stage 1: Placebo|Participants received matching oral placebo during Stage 1 for 5 consecutive weeks.
11099858|NCT01584440|FG002|Participant Flow|AVP-923 in Stage 1/AVP-923 in Stage 2|Participants received oral AVP-923 during Stage 1 for 5 consecutive weeks. Participants received AVP-923-20 QD in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 1 (Days 1 to 7), AVP-923-20 BID during the next 2 consecutive weeks (Days 8 to 21), and AVP-923-30 BID during the final 2 weeks of Stage 1 (Days 22 to 35). Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants continued to receive AVP-923-30 BID for the entire 5-week duration of Stage 2. Participants received AVP-923-20 QD in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 2 (Days 36 to 42), AVP-923-20 BID during the next 2 consecutive weeks (Days 43 to 56), and AVP-923-30 BID during the final 2 weeks of Stage 2 (Days 57 to 70).
11099859|NCT01584440|FG003|Participant Flow|Placebo in Stage 1/AVP-923 in Stage 2|Participants received matching oral placebo during Stage 1 for 5 consecutive weeks. Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants who were randomized to placebo in Stage 1 were stratified (based on their clinical response during Stage 1) into two subgroups (responders or non-responders) and were re-randomized to receive AVP-923 in Stage 2. Participants received AVP-923-20 QD in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 2 (Days 36 to 42), AVP-923-20 BID during the next 2 consecutive weeks (Days 43 to 56), and AVP-923-30 BID during the final 2 weeks of Stage 2 (Days 57 to 70).
10845984|NCT00271856|BG001|Baseline|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
10845985|NCT00271856|BG002|Baseline|Total|Total of all reporting groups
10845986|NCT00271856|FG000|Participant Flow|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
10845987|NCT00271856|FG001|Participant Flow|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
11099860|NCT01584440|FG004|Participant Flow|Placebo in Stage 1/Placebo in Stage 2|Participants received matching oral placebo during Stage 1 for 5 consecutive weeks. Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants who were randomized to placebo in Stage 1 were stratified (based on their clinical response during Stage 1) into two subgroups (responders or non-responders) and were re-randomized to receive matching placebo BID throughout Stage 2.
11099861|NCT01584440|OG000|Outcome|Placebo|All participants randomized to receive placebo in Stage 1, and all placebo non-responders re-randomized at Stage 2 to placebo
11099862|NCT01584440|OG001|Outcome|AVP-923|All participants randomized to receive AVP-923 in Stage 1, and all placebo non-responders re-randomized at Stage 2 to AVP-923.
11099863|NCT01584440|OG000|Outcome|All AVP-923|Participants received AVP-923 in either stage.
11099864|NCT01584440|OG001|Outcome|Placebo|Participants received placebo in either stage.
11099865|NCT01584440|OG001|Outcome|AVP-923|All participants randomized to receive AVP-923 in Stage 1, and all placebo non-responders re-randomized at Stage 2 to AVP-923
11099866|NCT01584440|OG000|Outcome|AVP-923 in Stage 1/AVP-923 in Stage 2|Participants received oral AVP-923 during Stage 1 for 5 consecutive weeks. Participants received AVP-923-20 once daily (QD) in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 1 (Days 1 to 7), AVP-923-20 twice a day (BID) during the next 2 consecutive weeks (Days 8 to 21), and AVP-923-30 BID the final 2 weeks of Stage 1 (Days 22 to 35). Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants continued to receive AVP-923-30 BID for the entire 5-week duration of Stage 2. Participants received AVP-923-20 QD in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 2 (Days 36 to 42), AVP-923-20 BID during the next 2 consecutive weeks (Days 43 to 56), and AVP-923-30 BID the final 2 weeks of Stage 2 (Days 57 to 70).
11099867|NCT01584440|OG001|Outcome|Placebo in Stage 1/AVP-923 in Stage 2|Participants receive matching oral placebo during Stage 1 for 5 consecutive weeks. Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants who were randomized to placebo in Stage 1 were stratified (based on their clinical response during Stage 1) into two subgroups (responders or non-responders) and were re-randomized to receive AVP-923 in Stage 2. Participants received AVP-923-20 QD in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 2 (Days 36 to 42), AVP-923-20 BID during the next 2 consecutive weeks (Days 43 to 56), and AVP-923-30 BID the final 2 weeks of Stage 2 (Days 57 to 70).
11099868|NCT01584440|OG002|Outcome|Placebo in Stage 1/Placebo in Stage 2|Participants receive matching oral placebo during Stage 1 for 5 consecutive weeks. Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants who were randomized to placebo in Stage 1 were stratified (based on their clinical response during Stage 1) into two subgroups (responders or non-responders) and were re-randomized to receive matching placebo BID throughout Stage 2.
11099869|NCT01584440|EG000|Reported Event|AVP-923 in Stage 1/AVP-923 in Stage 2|Participants received oral AVP-923 during Stage 1 for 5 consecutive weeks. Participants received AVP-923-20 once daily (QD) in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 1 (Days 1 to 7), AVP-923-20 twice a day (BID) during the next 2 consecutive weeks (Days 8 to 21), and AVP-923-30 BID during the final 2 weeks of Stage 1 (Days 22 to 35). Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants continued to receive AVP-923-30 BID for the entire 5-week duration of Stage 2. Participants received AVP-923-20 QD in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 2 (Days 36 to 42), AVP-923-20 BID during the next 2 consecutive weeks (Days 43 to 56), and AVP-923-30 BID during the final 2 weeks of Stage 2 (Days 57 to 70).
11099870|NCT01584440|EG001|Reported Event|Placebo in Stage 1/AVP-923 in Stage 2|Participants received matching oral placebo during Stage 1 for 5 consecutive weeks. Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants who were randomized to placebo in Stage 1 were stratified (based on their clinical response during Stage 1) into two subgroups (responders or non-responders) and were re-randomized to receive AVP-923 in Stage 2. Participants received AVP-923-20 QD in the morning and placebo in the evening (to maintain the blind) during the first week of Stage 2 (Days 36 to 42), AVP-923-20 BID during the next 2 consecutive weeks (Days 43 to 56), and AVP-923-30 BID during the final 2 weeks of Stage 2 (Days 57 to 70).
11099871|NCT01584440|EG002|Reported Event|Placebo in Stage 1/Placebo in Stage 2|Participants received matching oral placebo during Stage 1 for 5 consecutive weeks. Participants who completed Stage 1 were eligible to participate in Stage 2 of the study. Participants who were randomized to placebo in Stage 1 were stratified (based on their clinical response during Stage 1) into two subgroups (responders or non-responders) and were re-randomized to receive matching placebo BID throughout Stage 2.
11099872|NCT01584479|BG000|Baseline|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
11099873|NCT01584479|BG001|Baseline|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
11099874|NCT01584479|BG002|Baseline|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
11099875|NCT01584479|BG003|Baseline|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
11099876|NCT01584479|BG004|Baseline|Total|Total of all reporting groups
11099877|NCT01584479|FG000|Participant Flow|Low Risk Experimental Group|"1 visit - Low Risk 732 evaluable subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
11099878|NCT01584479|FG001|Participant Flow|Low Risk Control Group|"2 visits - Low Risk 1,668 evaluable subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
11099879|NCT01584479|FG002|Participant Flow|High Risk Experimental Group|"1 visit - High Risk 852 evaluable subjects~High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
11099880|NCT01584479|FG003|Participant Flow|High Risk Control Group|"2 visits - High Risk 1,847 evaluable subjects~High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
11099881|NCT01584479|OG000|Outcome|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
11099882|NCT01584479|OG001|Outcome|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
11099883|NCT01584479|OG002|Outcome|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
11099884|NCT01584479|OG003|Outcome|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
11099885|NCT01584479|EG000|Reported Event|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
11099886|NCT01584479|EG001|Reported Event|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
11099887|NCT01584479|EG002|Reported Event|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
11099888|NCT01584479|EG003|Reported Event|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
11099889|NCT01584518|BG000|Baseline|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
11099890|NCT01584518|BG001|Baseline|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
11099891|NCT01584518|BG002|Baseline|Total|Total of all reporting groups
11099892|NCT01584518|FG000|Participant Flow|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
11099893|NCT01584518|FG001|Participant Flow|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
11099894|NCT01584518|OG000|Outcome|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
11099895|NCT01584518|OG001|Outcome|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
11099896|NCT01584518|EG000|Reported Event|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
11099897|NCT01584518|EG001|Reported Event|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
11099898|NCT01584544|BG000|Baseline|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099899|NCT01584544|BG001|Baseline|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099900|NCT01584544|BG002|Baseline|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099901|NCT01584544|BG003|Baseline|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099902|NCT01584544|BG004|Baseline|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099903|NCT01584544|BG005|Baseline|Total|Total of all reporting groups
10845988|NCT00271856|OG000|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
11099904|NCT01584544|FG000|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099905|NCT01584544|FG001|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099906|NCT01584544|FG002|Participant Flow|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099907|NCT01584544|FG003|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099908|NCT01584544|FG004|Participant Flow|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099909|NCT01584544|OG000|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099910|NCT01584544|OG001|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099911|NCT01584544|OG002|Outcome|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099912|NCT01584544|OG003|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099913|NCT01584544|OG004|Outcome|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099914|NCT01584544|EG000|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099915|NCT01584544|EG001|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099916|NCT01584544|EG002|Reported Event|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099917|NCT01584544|EG003|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099918|NCT01584544|EG004|Reported Event|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
11099919|NCT01584609|BG000|Baseline|Penumbra System With Separator 3D|Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
11099920|NCT01584609|BG001|Baseline|Penumbra System Alone|Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
11099921|NCT01584609|BG002|Baseline|Total|Total of all reporting groups
11099922|NCT01584609|FG000|Participant Flow|Penumbra System With Separator 3D|Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
11099923|NCT01584609|FG001|Participant Flow|Penumbra System Alone|Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
11099924|NCT01584609|OG000|Outcome|Penumbra System With Separator 3D|Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
11099925|NCT01584609|OG001|Outcome|Penumbra System Alone|Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
11099926|NCT01584609|EG000|Reported Event|Penumbra System With Separator 3D|Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
11099927|NCT01584609|EG001|Reported Event|Penumbra System Alone|Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
11099928|NCT01584648|BG000|Baseline|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11099929|NCT01584648|BG001|Baseline|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
11099930|NCT01584648|BG002|Baseline|Total|Total of all reporting groups
11099931|NCT01584648|FG000|Participant Flow|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11126395|NCT01733121|FG001|Participant Flow|Valbenazine|Participants could receive valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks); flexible dose escalation.
11126396|NCT01733121|OG000|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
11099932|NCT01584648|FG001|Participant Flow|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
11099933|NCT01584648|OG000|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11099934|NCT01584648|OG001|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
11099935|NCT01584648|OG002|Outcome|Crossover Dabrafenib + Trametinib|Crossover Dabrafenib + Trametinib
11099936|NCT01584648|EG000|Reported Event|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11099937|NCT01584648|EG001|Reported Event|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
11099938|NCT01584648|EG002|Reported Event|Crossover Dabrafenib + Trametinib|Crossover Dabrafenib + Trametinib
11099939|NCT01584648|EG003|Reported Event|All Patients|All Patients
11099940|NCT01584843|BG000|Baseline|Non-treatment, Then GSK1358820|Participants (par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD or with a BSA >=20 PD and <50 PD received no treatment from the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11099941|NCT01584843|BG001|Baseline|GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099942|NCT01584843|BG002|Baseline|GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD or with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099943|NCT01584843|BG003|Baseline|GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099944|NCT01584843|BG004|Baseline|Total|Total of all reporting groups
11099945|NCT01584843|FG000|Participant Flow|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11126397|NCT01733121|OG001|Outcome|Valbenazine|Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
11099946|NCT01584843|FG001|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099947|NCT01584843|FG002|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099948|NCT01584843|FG003|Participant Flow|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11099949|NCT01584843|FG004|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099950|NCT01584843|FG005|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099951|NCT01584843|OG000|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11099952|NCT01584843|OG001|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099953|NCT01584843|OG002|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11126398|NCT01733121|OG000|Outcome|Placebo|Participants received Placebo capsule (matching NBI-98854 capsules) once daily for 6 weeks.
11126399|NCT01733121|OG001|Outcome|NBI-98854|Participants first received NBI-98854 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
11126400|NCT01733121|EG000|Reported Event|Placebo|Participants received Placebo capsule (matching valbenazine capsules) daily for 6 weeks followed by 2 weeks posttreatment period.
11099954|NCT01584843|OG003|Outcome|SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11099955|NCT01584843|OG004|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099956|NCT01584843|OG005|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099957|NCT01584843|OG003|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11099958|NCT01584843|OG000|Outcome|BSA >=10 PD and <20 PD: Non-treatment|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11099959|NCT01584843|OG003|Outcome|BSA >=20 PD and <50 PD: Non-treatment|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11099960|NCT01584843|EG000|Reported Event|Non-treatment|Participants (par) with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the First Treatment Period (FTP). Par were re-evaluated at Week 4 and Weeks 12-24. Par who did not meet the injection criteria at any time point remained in the FTP group and were observed up to study Week 52.
11099961|NCT01584843|EG001|Reported Event|Non-treatment, Then GSK1358820|Par with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
11126401|NCT01733121|EG001|Reported Event|Valbenazine|Participants first received valbenazine 5mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks) followed by 2 weeks posttreatment period.
11126402|NCT01733186|BG000|Baseline|Dose A Cohort|"Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect~Cartilage defect size range: 2 to 5 cm2 (Dose A)~CARTISTEM®"
10878596|NCT00453349|BG001|Baseline|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
10878597|NCT00453349|BG002|Baseline|Total|Total of all reporting groups
10878598|NCT00453349|FG000|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
11099962|NCT01584843|EG002|Reported Event|GSK1358820 1.25 U|Par with a BSA greater than or equal to 10 PD and less than 20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099963|NCT01584843|EG003|Reported Event|GSK1358820 2.5 U|Participants with BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099964|NCT01584843|EG004|Reported Event|GSK1358820 5.0 U|Par with a BSA greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
11099965|NCT01585025|BG000|Baseline|Primary BAD|Defined as SeHCAT <10% without other causes such as Crohn's disease and/or ileal resection
11099966|NCT01585025|BG001|Baseline|Secondary BAD|With Crohn's disease or ileal resection
11099967|NCT01585025|BG002|Baseline|Idiopathic Diarrhoea Controls|Chronic diarrhoea with SeHCAT >15% and no Crohn's or ileal resection
11099968|NCT01585025|BG003|Baseline|Total|Total of all reporting groups
11099969|NCT01585025|FG000|Participant Flow|Primary BAD|Defined as SeHCAT <10% without other causes such as Crohn's disease and/or ileal resection
11099970|NCT01585025|FG001|Participant Flow|Secondary BAD|With Crohn's disease or ileal resection
11099971|NCT01585025|FG002|Participant Flow|Idiopathic Diarrhoea Controls|Chronic diarrhoea with SeHCAT >15% and no Crohn's or ileal resection
11099972|NCT01585025|OG000|Outcome|Primary BAD|Defined as SeHCAT <10% without other causes such as Crohn's disease and/or ileal resection
11099973|NCT01585025|OG001|Outcome|Secondary BAD|With Crohn's disease or ileal resection
11099974|NCT01585025|OG002|Outcome|Idiopathic Diarrhoea Controls|Chronic diarrhoea with SeHCAT >15% and no Crohn's or ileal resection
11099975|NCT01585025|EG000|Reported Event|Primary BAD|Defined as SeHCAT <10% without other causes such as Crohn's disease and/or ileal resection
11099976|NCT01585025|EG001|Reported Event|Secondary BAD|With Crohn's disease or ileal resection
11099977|NCT01585025|EG002|Reported Event|Idiopathic Diarrhoea Controls|Chronic diarrhoea with SeHCAT >15% and no Crohn's or ileal resection
11099978|NCT01585038|BG000|Baseline|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
11099979|NCT01585038|BG001|Baseline|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
11099980|NCT01585038|BG002|Baseline|Total|Total of all reporting groups
11099981|NCT01585038|FG000|Participant Flow|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
11099982|NCT01585038|FG001|Participant Flow|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
11099983|NCT01585038|OG000|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
11099984|NCT01585038|OG001|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
11099985|NCT01585038|EG000|Reported Event|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
11099986|NCT01585038|EG001|Reported Event|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
11099987|NCT01585129|BG000|Baseline|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
11099988|NCT01585129|BG001|Baseline|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
11099989|NCT01585129|BG002|Baseline|Total|Total of all reporting groups
11099990|NCT01585129|FG000|Participant Flow|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
11099991|NCT01585129|FG001|Participant Flow|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
11099992|NCT01585129|OG000|Outcome|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
11099993|NCT01585129|OG001|Outcome|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
11099994|NCT01585129|EG000|Reported Event|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
11099995|NCT01585129|EG001|Reported Event|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
11099996|NCT01585155|BG000|Baseline|TA-650|TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
11099997|NCT01585155|FG000|Participant Flow|TA-650|Patients received TA-650 5 mg/kg at Weeks 0, 2, and 6; patients with a decreased CAI score at Week 8 were considered to be responders and received further doses at Week 14 and 22. Non-responders (patients with unchanged/increased CAI score) at Week 8 did not receive further study treatment. Assessments were conducted until Week 30 in responders and until Week 14 in non-responders.
11099998|NCT01585155|OG000|Outcome|TA-650|TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
11099999|NCT01585155|EG000|Reported Event|TA-650|TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
11100000|NCT01585168|BG000|Baseline|Family History Positive (FHP)|People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
11100001|NCT01585168|BG001|Baseline|Family History Negative (FHN)|People who have no affected first- or second-degree relatives.
11100002|NCT01585168|BG002|Baseline|Total|Total of all reporting groups
11100003|NCT01585168|FG000|Participant Flow|Family History Negative (FHN): Memantine, Then Placebo|"Participants received 2-20mg tablets of Memantine on the morning of the first study visit, then received 2 matching placebo tablets on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.~Family History Negative (FHN): People who have no affected first- or second-degree relatives."
11100004|NCT01585168|FG001|Participant Flow|Family History Negative (FHN): Placebo, Then Memantine|"Participants received 2 matching placebo tablets on the morning of the first study visit, then received 2-20mg tablets of Memantine on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.~Family History Negative (FHN): People who have no affected first- or second-degree relatives."
11100005|NCT01585168|FG002|Participant Flow|Family History Positive (FHP): Memantine, Then Placebo|"Participants received 2-20mg tablets of Memantine on the morning of the first study visit, then received 2 matching placebo tablets on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.~Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism."
11100006|NCT01585168|FG003|Participant Flow|Family History Positive (FHP): Placebo, Then Memantine|"Participants received 2 matching placebo tablets on the morning of the first study visit, then received 2-20mg tablets of Memantine on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.~Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism."
11100007|NCT01585168|OG000|Outcome|FHN - Memantine|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
11100008|NCT01585168|OG001|Outcome|FHN - Placebo|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
11100009|NCT01585168|OG002|Outcome|FHP - Memantine|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
11100010|NCT01585168|OG003|Outcome|FHP - Placebo|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
11100011|NCT01585168|EG000|Reported Event|Family History Positive (FHP)|People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
11100012|NCT01585168|EG001|Reported Event|Family History Negative (FHN)|People who have no affected first- or second-degree relatives.
11100013|NCT01585194|BG000|Baseline|Treatment (Nivolumab, Ipilimumab)|"INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11100014|NCT01585194|FG000|Participant Flow|Treatment (Nivolumab, Ipilimumab)|"INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11100015|NCT01585194|OG000|Outcome|Treatment (Nivolumab, Ipilimumab)|"INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11100016|NCT01585194|EG000|Reported Event|Treatment (Nivolumab, Ipilimumab)|"INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11100017|NCT01585207|BG000|Baseline|Vigabatrin|3 tablets, bid for 8 weeks
11100018|NCT01585207|FG000|Participant Flow|Vigabatrin|3 tablets, bid for 8 weeks
11100019|NCT01585207|OG000|Outcome|Vigabatrin|3 tablets, bid for 8 weeks
11100020|NCT01585207|EG000|Reported Event|Vigabatrin|3 tablets, bid for 8 weeks
11100021|NCT01585246|BG000|Baseline|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
11100022|NCT01585246|BG001|Baseline|Phase 1: Saw Palmetto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
11100023|NCT01585246|BG002|Baseline|Phase 1: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
11100024|NCT01585246|BG003|Baseline|Active Comparator: Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg
11100025|NCT01585246|BG004|Baseline|Placebo Comparator: Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
11100026|NCT01585246|BG005|Baseline|Total|Total of all reporting groups
11100027|NCT01585246|FG000|Participant Flow|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
11100028|NCT01585246|FG001|Participant Flow|Phase 1: Saw Palmentto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
11100029|NCT01585246|FG002|Participant Flow|Phase 1: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
11100030|NCT01585246|FG003|Participant Flow|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
11100031|NCT01585246|FG004|Participant Flow|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
11100032|NCT01585246|OG000|Outcome|Phase 1: Men in 320mg/Day DFP|Men assigned to the 320mg/Day group in the dose finding phase.
11100033|NCT01585246|OG001|Outcome|Phase 1: Men in 640mg/Day DFP|Men assigned to the 640mg/Day group in the dose finding phase.
11100034|NCT01585246|OG002|Outcome|Phase 1: Men in 960mg/Day DFP|Men assigned to the 960mg/Day group in the dose finding phase.
11100035|NCT01585246|OG003|Outcome|Phase 2: Saw Palmetto 960 mg RCT|Men assigned to the 960mg/Day of Saw Palmetto in the pilot RCT Phase
11100036|NCT01585246|OG004|Outcome|Phase 2: Placebo RCT|Men assigned to the placebo in the pilot RCT Phase
11100037|NCT01585246|OG000|Outcome|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
11100038|NCT01585246|OG001|Outcome|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
11100039|NCT01585246|OG000|Outcome|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
11100040|NCT01585246|OG001|Outcome|Phase I: Saw Palmetto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
11100041|NCT01585246|OG002|Outcome|Phase I: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960 mg/day of Saw Palmetto Soft Gel capsules.
11100042|NCT01585246|EG000|Reported Event|Phase 1: The Dose Finding Phase (DFP)|Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose.
11100043|NCT01585246|EG001|Reported Event|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960 mg.
11100044|NCT01585246|EG002|Reported Event|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
11100045|NCT01585272|BG000|Baseline|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
11100046|NCT01585272|FG000|Participant Flow|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
11100047|NCT01585272|OG000|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
11100048|NCT01585272|EG000|Reported Event|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
11100049|NCT01585298|BG000|Baseline|Fingolimod|Fingolimod 0.5 mg by mouth once daily for 7 days.
11100050|NCT01585298|FG000|Participant Flow|Fingolimod|Fingolimod 0.5 mg by mouth once daily for 7 days.
11100051|NCT01585298|OG000|Outcome|Fingolimod|Fingolimod 0.5 mg by mouth once daily for 7 days.
11100052|NCT01585298|EG000|Reported Event|Fingolimod|Fingolimod 0.5 mg by mouth once daily for 7 days.
11100053|NCT01585324|BG000|Baseline|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
11100054|NCT01585324|FG000|Participant Flow|Peginterferon Alpha-2a + Ribavirin|Participants infected with hepatitis C virus (HCV) genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 micrograms (mcg) subcutaneously once a week and ribavirin tablet, 1000-1200 milligrams (mg) by body weight (1000 mg if weight less than (<) 75 kilogram [kg]; 1200 mg if weight greater than or equal to (≥) 75 kg) orally split into 2 daily doses, for a total of 48 weeks.
11100055|NCT01585324|OG000|Outcome|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
11100056|NCT01585324|OG000|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
11100057|NCT01585324|OG001|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
11100058|NCT01585324|EG000|Reported Event|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
11100059|NCT01585428|BG000|Baseline|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11100060|NCT01585428|BG001|Baseline|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11100061|NCT01585428|BG002|Baseline|Total|Total of all reporting groups
11100062|NCT01585428|FG000|Participant Flow|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11100063|NCT01585428|FG001|Participant Flow|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
10845989|NCT00271856|OG001|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
11100064|NCT01585428|OG000|Outcome|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11100065|NCT01585428|OG001|Outcome|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11100066|NCT01585428|OG000|Outcome|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11100067|NCT01585428|EG000|Reported Event|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11100068|NCT01585428|EG001|Reported Event|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11100069|NCT01585441|BG000|Baseline|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
11100070|NCT01585441|BG001|Baseline|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
11100071|NCT01585441|BG002|Baseline|Total|Total of all reporting groups
11100072|NCT01585441|FG000|Participant Flow|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
11100073|NCT01585441|FG001|Participant Flow|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
11100074|NCT01585441|OG000|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
11100075|NCT01585441|OG001|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
11100076|NCT01585441|EG000|Reported Event|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
11100077|NCT01585441|EG001|Reported Event|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
11100078|NCT01585558|BG000|Baseline|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
11100079|NCT01585558|BG001|Baseline|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
11100080|NCT01585558|BG002|Baseline|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
11100081|NCT01585558|BG003|Baseline|Total|Total of all reporting groups
11100082|NCT01585558|FG000|Participant Flow|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
11100083|NCT01585558|FG001|Participant Flow|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
11100084|NCT01585558|FG002|Participant Flow|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
11100085|NCT01585558|OG000|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
11100086|NCT01585558|OG001|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
11100087|NCT01585558|OG002|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
11100088|NCT01585558|EG000|Reported Event|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
11100089|NCT01585558|EG001|Reported Event|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
11100090|NCT01585558|EG002|Reported Event|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
11100091|NCT01585584|BG000|Baseline|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
11100092|NCT01585584|FG000|Participant Flow|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
11100093|NCT01585584|OG000|Outcome|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
11100094|NCT01585584|EG000|Reported Event|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
11100095|NCT01585597|BG000|Baseline|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
11100096|NCT01585597|FG000|Participant Flow|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
11100097|NCT01585597|OG000|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
11100098|NCT01585597|EG000|Reported Event|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
11100099|NCT01585766|BG000|Baseline|PLACEBO-IV-SC|Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
11100100|NCT01585766|BG001|Baseline|MEDI-551 30 Mg-IV|Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
11100101|NCT01585766|BG002|Baseline|MEDI-551 60 Mg-SC|Participants received SC injection of 60 mg MEDI-551 on Day 1.
11100102|NCT01585766|BG003|Baseline|MEDI-551 100 Mg-IV|Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
11100103|NCT01585766|BG004|Baseline|MEDI-551 300 Mg-SC|Participants received SC injection of 300 mg MEDI-551 on Day 1.
11100104|NCT01585766|BG005|Baseline|MEDI-551 600 Mg-IV|Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
11100105|NCT01585766|BG006|Baseline|Total|Total of all reporting groups
11100106|NCT01585766|FG000|Participant Flow|PLACEBO-IV-SC|Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
11100107|NCT01585766|FG001|Participant Flow|MEDI-551 30 Mg-IV|Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
11100108|NCT01585766|FG002|Participant Flow|MEDI-551 60 Mg-SC|Participants received SC injection of 60 mg MEDI-551 on Day 1.
11100109|NCT01585766|FG003|Participant Flow|MEDI-551 100 Mg-IV|Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
11100110|NCT01585766|FG004|Participant Flow|MEDI-551 300 Mg-SC|Participants received SC injection of 300 mg MEDI-551 on Day 1.
11100111|NCT01585766|FG005|Participant Flow|MEDI-551 600 Mg-IV|Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
11100112|NCT01585766|OG000|Outcome|PLACEBO-IV-SC|Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
11100113|NCT01585766|OG001|Outcome|MEDI-551 30 Mg-IV|Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
11100114|NCT01585766|OG002|Outcome|MEDI-551 60 Mg-SC|Participants received SC injection of 60 mg MEDI-551 on Day 1.
11100115|NCT01585766|OG003|Outcome|MEDI-551 100 Mg-IV|Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
11100116|NCT01585766|OG004|Outcome|MEDI-551 300 Mg-SC|Participants received SC injection of 300 mg MEDI-551 on Day 1.
11100117|NCT01585766|OG005|Outcome|MEDI-551 600 Mg-IV|Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
11100118|NCT01585766|OG000|Outcome|MEDI-551 30 Mg-IV|Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
11100119|NCT01585766|OG001|Outcome|MEDI-551 60 Mg-SC|Participants received SC injection of 60 mg MEDI-551 on Day 1.
11100120|NCT01585766|OG002|Outcome|MEDI-551 100 Mg-IV|Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
11100121|NCT01585766|OG003|Outcome|MEDI-551 300 Mg-SC|Participants received SC injection of 300 mg MEDI-551 on Day 1.
11100122|NCT01585766|OG004|Outcome|MEDI-551 600 Mg-IV|Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
11100123|NCT01585766|OG000|Outcome|MEDI-551 60 Mg-SC|Participants received SC injection of 60 mg MEDI-551 on Day 1.
11100124|NCT01585766|OG001|Outcome|MEDI-551 300 Mg-SC|Participants received SC injection of 300 mg MEDI-551 on Day 1.
11100125|NCT01585766|EG000|Reported Event|PLACEBO-IV-SC|Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
11100126|NCT01585766|EG001|Reported Event|MEDI-551 60 Mg-SC|Participants received SC injection of 60 mg MEDI-551 on Day 1.
11100127|NCT01585766|EG002|Reported Event|MEDI-551 100 Mg-IV|Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
11100128|NCT01585766|EG003|Reported Event|MEDI-551 300 Mg-SC|Participants received SC injection of 300 mg MEDI-551 on Day 1.
11100129|NCT01585766|EG004|Reported Event|MEDI-551 30 Mg-IV|Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
11100130|NCT01585766|EG005|Reported Event|MEDI-551 600 Mg-IV|Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
11100131|NCT01585779|BG000|Baseline|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
11100132|NCT01585779|BG001|Baseline|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
11100133|NCT01585779|BG002|Baseline|Total|Total of all reporting groups
11100134|NCT01585779|FG000|Participant Flow|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
11100135|NCT01585779|FG001|Participant Flow|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
11100136|NCT01585779|OG000|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
11100137|NCT01585779|OG001|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
11100138|NCT01585779|OG001|Outcome|Tri-Ad® Implant|The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
11100139|NCT01585779|EG000|Reported Event|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
11100140|NCT01585779|EG001|Reported Event|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
11100141|NCT01585831|BG000|Baseline|Testosterone Gel 1%|"Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.~Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs."
11100142|NCT01585831|BG001|Baseline|Placebo Gel|"Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.~Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist."
11100143|NCT01585831|BG002|Baseline|Total|Total of all reporting groups
11100144|NCT01585831|FG000|Participant Flow|Testosterone Gel 1%|"Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.~Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs."
11100145|NCT01585831|FG001|Participant Flow|Placebo Gel|"Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.~Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist."
11100146|NCT01585831|OG000|Outcome|Testosterone Gel 1%|"Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.~Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs."
11100147|NCT01585831|OG001|Outcome|Placebo Gel|"Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.~Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist."
11100148|NCT01585831|EG000|Reported Event|Testosterone Gel 1%|"Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.~Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs."
11100149|NCT01585831|EG001|Reported Event|Placebo Gel|"Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.~Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist."
11100150|NCT01585961|BG000|Baseline|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
11100151|NCT01585961|FG000|Participant Flow|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
11100152|NCT01585961|OG000|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
11100153|NCT01585961|EG000|Reported Event|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
11100154|NCT01585987|BG000|Baseline|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
11100155|NCT01585987|BG001|Baseline|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment.
11100156|NCT01585987|BG002|Baseline|Total|Total of all reporting groups
11126403|NCT01733186|BG001|Baseline|Dose B Cohort|"Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect~Cartilage defect size range: above 5 cm2 (Dose B)~CARTISTEM®"
11126404|NCT01733186|BG002|Baseline|Total|Total of all reporting groups
10878599|NCT00453349|FG001|Participant Flow|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
10878600|NCT00453349|OG000|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
11100157|NCT01585987|FG000|Participant Flow|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
11100158|NCT01585987|FG001|Participant Flow|All Best Supportive Care (BSC)|All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used
11100159|NCT01585987|OG000|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
11100160|NCT01585987|OG001|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
11100161|NCT01585987|EG000|Reported Event|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
11100162|NCT01585987|EG001|Reported Event|Active Best Supportive Care (BSC)|Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization)
11100163|NCT01585987|EG002|Reported Event|Non-Active BSC|Non-Active BSC involves supportive care with cessation of chemotherapy (no active drug)
11100164|NCT01586026|BG000|Baseline|Combined Demographics|Demographics of 171 subjects that contributed to final data analysis
11100165|NCT01586026|FG000|Participant Flow|Group A|Maintenance flushes at days 1-28
11100166|NCT01586026|FG001|Participant Flow|Group B|Maintenance flushes at days 29-56
11100167|NCT01586026|FG002|Participant Flow|Group C|Maintenance flushes at days 57+
11100168|NCT01586026|OG000|Outcome|Group A|Maintenance flushes at days 1-28
11100169|NCT01586026|OG001|Outcome|Group B|Maintenance flushes at days 29-56
11100170|NCT01586026|OG002|Outcome|Group C|Maintenance flushes at days 57+
11100171|NCT01586026|EG000|Reported Event|Group A|Maintenance flushes at days 1-28
11100172|NCT01586026|EG001|Reported Event|Group B|Maintenance flushes at days 29-56
11100173|NCT01586026|EG002|Reported Event|Group C|Maintenance flushes at days 57+
11100174|NCT01586039|BG000|Baseline|Compact Fluorescent Light 90 Lux|"90 lux exposure of a commercially available Compact Fluorescent Light (CFL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100175|NCT01586039|BG001|Baseline|Blue-depleted LED Light 90 Lux|"90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100176|NCT01586039|BG002|Baseline|Compact Fluorescent Light 50 Lux|"50 lux exposure of a commercially available Compact Fluorescent Light (CFL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100177|NCT01586039|BG003|Baseline|Blue-depleted LED Light 50 Lux|"50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100178|NCT01586039|BG004|Baseline|Total|Total of all reporting groups
11100179|NCT01586039|FG000|Participant Flow|Compact Fluorescent Light 90 Lux|"90 lux exposure of a commercially available Compact Fluorescent Light (CFL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100180|NCT01586039|FG001|Participant Flow|Blue-depleted LED Light 90 Lux|"90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100181|NCT01586039|FG002|Participant Flow|Compact Fluorescent Light 50 Lux|"50 lux exposure of a commercially available Compact Fluorescent Light (CFL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100182|NCT01586039|FG003|Participant Flow|Blue-depleted LED Light 50 Lux|"50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100183|NCT01586039|OG000|Outcome|Compact Fluorescent Light 90 Lux|"90 lux exposure of a commercially available Compact Fluorescent Light (CFL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100184|NCT01586039|OG001|Outcome|Blue-depleted LED Light 90 Lux|"90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100185|NCT01586039|OG002|Outcome|Compact Fluorescent Light 50 Lux|"50 lux exposure of a commercially available Compact Fluorescent Light (CFL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100186|NCT01586039|OG003|Outcome|Blue-depleted LED Light 50 Lux|"50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100187|NCT01586039|EG000|Reported Event|Compact Fluorescent Light 90 Lux|"90 lux exposure of a commercially available Compact Fluorescent Light (CFL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100188|NCT01586039|EG001|Reported Event|Blue-depleted LED Light 90 Lux|"90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100189|NCT01586039|EG002|Reported Event|Compact Fluorescent Light 50 Lux|"50 lux exposure of a commercially available Compact Fluorescent Light (CFL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100190|NCT01586039|EG003|Reported Event|Blue-depleted LED Light 50 Lux|"50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).~Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL)."
11100191|NCT01586091|BG000|Baseline|Day 2|Intake on 0 hours and 12 hours Intake Levocetirizn
11100192|NCT01586091|BG001|Baseline|Day 3|Intake on 0 hours and 12 hours Intake Fexofenadine
11100193|NCT01586091|BG002|Baseline|Day 1|Intake on 0 hours and 12 hours Intake Placebo
11100194|NCT01586091|BG003|Baseline|Total|Total of all reporting groups
11100195|NCT01586091|FG000|Participant Flow|Day 1|Intake of Placebo- Fexofenadine 6 mg - Levocetirizin 5 mg
11100196|NCT01586091|FG001|Participant Flow|Day 2|Intake of Fexofenadine 6 mg - Levocetirizin 5 mg - Placebo
11100197|NCT01586091|FG002|Participant Flow|Day 3|Intake of Placebo- Levocetirizin 5 mg- Fexofenadine 60
11100198|NCT01586091|OG000|Outcome|Levocetirizin|5 mg once daily
11100199|NCT01586091|OG001|Outcome|Fexofenadine|60 mg twice daily
11100200|NCT01586091|OG002|Outcome|Placebo|Placebo as comparison to Levocetirizin
11100201|NCT01586091|OG000|Outcome|Placebo|Placebo as comparison to Levocetirizin
11100202|NCT01586091|OG001|Outcome|Levocetirizin|5 mg once daily
11100203|NCT01586091|OG002|Outcome|Fexofenadine|60 mg twice daily
11100204|NCT01586091|EG000|Reported Event|Levocetirizine|5 mg once daily
11100205|NCT01586091|EG001|Reported Event|Fexofenadine|60 mg twice daily, oral
11100206|NCT01586091|EG002|Reported Event|Placebo|Placebo against Levocetirzine
11100207|NCT01586156|BG000|Baseline|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
11100208|NCT01586156|BG001|Baseline|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
11100209|NCT01586156|BG002|Baseline|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
11100210|NCT01586156|BG003|Baseline|Total|Total of all reporting groups
11100211|NCT01586156|FG000|Participant Flow|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
11100212|NCT01586156|FG001|Participant Flow|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
11100213|NCT01586156|FG002|Participant Flow|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
11100214|NCT01586156|OG000|Outcome|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
11100215|NCT01586156|OG001|Outcome|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
11100216|NCT01586156|OG002|Outcome|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
11100217|NCT01586156|EG000|Reported Event|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
11100218|NCT01586156|EG001|Reported Event|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
11100219|NCT01586156|EG002|Reported Event|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
11100220|NCT01586195|BG000|Baseline|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
11100221|NCT01586195|FG000|Participant Flow|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 milligram (mg) orally twice daily (BID) until disease progression.
11100222|NCT01586195|OG000|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
11100223|NCT01586195|EG000|Reported Event|Vemurafenib|Participants received vemurafenib 960 mg orally BID.
11100224|NCT01586312|BG000|Baseline|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
11100225|NCT01586312|BG001|Baseline|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
11100226|NCT01586312|BG002|Baseline|Total|Total of all reporting groups
11100227|NCT01586312|FG000|Participant Flow|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
11100228|NCT01586312|FG001|Participant Flow|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
11100229|NCT01586312|OG000|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
11100230|NCT01586312|OG001|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
11100231|NCT01586312|EG000|Reported Event|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
11100232|NCT01586312|EG001|Reported Event|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
11100233|NCT01586338|BG000|Baseline|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
11100234|NCT01586338|FG000|Participant Flow|Synvisc|Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
11100235|NCT01586338|OG000|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
11100236|NCT01586338|EG000|Reported Event|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
11100237|NCT01586364|BG000|Baseline|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
11100238|NCT01586364|FG000|Participant Flow|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
11100239|NCT01586364|OG000|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
11100240|NCT01586364|EG000|Reported Event|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
11100241|NCT01586624|BG000|Baseline|Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11126405|NCT01733186|FG000|Participant Flow|Dose A Cohort|"Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect~Cartilage defect size range: 2 to 5 cm2 (Dose A)~CARTISTEM®"
11100242|NCT01586624|BG001|Baseline|Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib )|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100243|NCT01586624|BG002|Baseline|Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib )|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100244|NCT01586624|BG003|Baseline|Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100245|NCT01586624|BG004|Baseline|Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100246|NCT01586624|BG005|Baseline|Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100247|NCT01586624|BG006|Baseline|Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100248|NCT01586624|BG007|Baseline|Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100249|NCT01586624|BG008|Baseline|Total|Total of all reporting groups
11100250|NCT01586624|FG000|Participant Flow|Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100251|NCT01586624|FG001|Participant Flow|Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100252|NCT01586624|FG002|Participant Flow|Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100253|NCT01586624|FG003|Participant Flow|Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100254|NCT01586624|FG004|Participant Flow|Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100255|NCT01586624|FG005|Participant Flow|Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100256|NCT01586624|FG006|Participant Flow|Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100257|NCT01586624|FG007|Participant Flow|Dose Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100258|NCT01586624|OG000|Outcome|Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11126406|NCT01733186|FG001|Participant Flow|Dose B Cohort|"Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect~Cartilage defect size range: above 5 cm2 (Dose B)~CARTISTEM®"
11100259|NCT01586624|OG001|Outcome|Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100260|NCT01586624|OG002|Outcome|Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100261|NCT01586624|OG003|Outcome|Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100262|NCT01586624|OG004|Outcome|Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100263|NCT01586624|OG005|Outcome|Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100264|NCT01586624|OG006|Outcome|Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100265|NCT01586624|OG007|Outcome|Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100266|NCT01586624|OG000|Outcome|Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100267|NCT01586624|EG000|Reported Event|Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100268|NCT01586624|EG001|Reported Event|Dose Escalation Phase Cohort 2 ( Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100269|NCT01586624|EG002|Reported Event|Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100270|NCT01586624|EG003|Reported Event|Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100271|NCT01586624|EG004|Reported Event|Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100272|NCT01586624|EG005|Reported Event|Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100273|NCT01586624|EG006|Reported Event|Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)|"Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100274|NCT01586624|EG007|Reported Event|Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)|"Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.~Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
11100275|NCT01586741|BG000|Baseline|Polypropylene Mesh|"Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.~Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training"
11100276|NCT01586741|BG001|Baseline|Quill Suture|"Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.~Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training"
11100277|NCT01586741|BG002|Baseline|Conservative Treatment|Regular abdominal exercises workout for three months for 30 patients.
11100278|NCT01586741|BG003|Baseline|Total|Total of all reporting groups
11100279|NCT01586741|FG000|Participant Flow|Quill Suture|"Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.~Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training"
11100280|NCT01586741|FG001|Participant Flow|Polypropylene Mesh|"Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.~Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training"
11100281|NCT01586741|FG002|Participant Flow|Conservative Treatment|Regular abdominal exercises workout for three months for 30 patients.
11100282|NCT01586741|OG000|Outcome|Polypropylene Mesh|"Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.~Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training"
11100283|NCT01586741|OG001|Outcome|Quill Suture|"Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.~Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training"
11100284|NCT01586741|OG002|Outcome|Conservative Treatment|Regular abdominal exercises workout for three months for 30 patients.
11100285|NCT01586741|EG000|Reported Event|Quill Suture|"Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.~Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training"
11100286|NCT01586741|EG001|Reported Event|Polypropylene Mesh|"Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.~Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training"
11100287|NCT01586741|EG002|Reported Event|Conservative Treatment|Regular abdominal exercises workout for three months for 30 patients.
11100288|NCT01586806|BG000|Baseline|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
11100289|NCT01586806|BG001|Baseline|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
11100290|NCT01586806|BG002|Baseline|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
11100291|NCT01586806|BG003|Baseline|Total|Total of all reporting groups
11100292|NCT01586806|FG000|Participant Flow|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
11100293|NCT01586806|FG001|Participant Flow|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
11100294|NCT01586806|FG002|Participant Flow|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
11100295|NCT01586806|OG000|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
11100296|NCT01586806|OG001|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
11100297|NCT01586806|OG002|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
11100298|NCT01586806|EG000|Reported Event|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
11100299|NCT01586806|EG001|Reported Event|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
11100300|NCT01586806|EG002|Reported Event|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
11100301|NCT01586819|BG000|Baseline|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
11100302|NCT01586819|BG001|Baseline|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
11100303|NCT01586819|BG002|Baseline|Total|Total of all reporting groups
11100304|NCT01586819|FG000|Participant Flow|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
11126407|NCT01733186|OG000|Outcome|Dose A Cohort|"Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect~Cartilage defect size range: 2 to 5 cm2 (Dose A)~CARTISTEM®"
11100305|NCT01586819|FG001|Participant Flow|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
11100306|NCT01586819|OG000|Outcome|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
11100307|NCT01586819|OG001|Outcome|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
11100308|NCT01586819|EG000|Reported Event|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
11100309|NCT01586819|EG001|Reported Event|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
11100310|NCT01586871|BG000|Baseline|Pediatric Control|Healthy pediatric control subjects
11100311|NCT01586871|BG001|Baseline|Adult Control|Healthy adult control subjects
11100312|NCT01586871|BG002|Baseline|Mucopolysaccharidosis (MPS ) Subjects|Mucopolysaccharidosis subjects type I, II, IIIA and VI.
11100313|NCT01586871|BG003|Baseline|Total|Total of all reporting groups
11100314|NCT01586871|FG000|Participant Flow|Pediatric Control Patients|The pediatric control patients were obtained from prior studies of insulin resistance and cardiovascular risk at the University of Minnesota.
11100315|NCT01586871|FG001|Participant Flow|Adult Controls|The adult controls were obtained from prior studies of insulin resistance and cardiovascular risk at the University of Minnesota.
11100316|NCT01586871|FG002|Participant Flow|MPS Patients|Clinical data (demographic information, anthropometrics, ethnicity, confirmation of diagnosis, and treatment status) from MPS patients were obtained from chart review. For this project, data from MPS I, MPS II, MPS IIIa and MPS VI was available.
11100317|NCT01586871|OG000|Outcome|Pediatric Control|Healthy pediatric control subjects
11100318|NCT01586871|OG001|Outcome|Adult Control|Healthy adult control subjects
11100319|NCT01586871|OG002|Outcome|Mucopolysaccharidosis (MPS ) Subjects|Mucopolysaccharidosis subjects type I, II, IIIA and VI.
11100320|NCT01586871|EG000|Reported Event|MPS Patients|Individuals with MPS disease (17 MPS I, 9 MPS II, 4 MPS IIIA , 3 MPS VI)
11100321|NCT01586871|EG001|Reported Event|Pediatric Controls|Healthy pediatric control subjects
11100322|NCT01586871|EG002|Reported Event|Adult Controls|Healthy adult control subjects
11100323|NCT01586897|BG000|Baseline|Use of Medication Metronome|"Medication Metronome: PCPs allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.~While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
11100324|NCT01586897|BG001|Baseline|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care~While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
11100325|NCT01586897|BG002|Baseline|Total|Total of all reporting groups
11100326|NCT01586897|FG000|Participant Flow|Use of Medication Metronome|"Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.~26 Primary Care Physicians were randomized to Use of Medication Metronome with 2049 patients analyzed."
11100327|NCT01586897|FG001|Participant Flow|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care~26 Primary Care Physicians randomized to Usual Care, with 1606 patients analyzed."
11100328|NCT01586897|OG000|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
11100329|NCT01586897|OG001|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
11224504|NCT02360475|BG001|Baseline|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11100330|NCT01586897|EG000|Reported Event|Use of Medication Metronome - PCPs|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia.
11100331|NCT01586897|EG001|Reported Event|Usual Care - PCPs|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
11100332|NCT01586897|EG002|Reported Event|Use of Medication Metronome - Patients|"Patients of PCPs allocated to the Use of Medication Metronome were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
11100333|NCT01586897|EG003|Reported Event|Usual Care - Patients|"Patients of PCPs allocated to Usual Care were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
11100334|NCT01586962|BG000|Baseline|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
11100335|NCT01586962|FG000|Participant Flow|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
11100336|NCT01586962|OG000|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
11100337|NCT01586962|EG000|Reported Event|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
11100338|NCT01586975|BG000|Baseline|Clopidogrel 75 mg|Clopidogrel 75 mg QD
11100339|NCT01586975|BG001|Baseline|Aspirin 81 mg|Aspirin 81 mg QD
11100340|NCT01586975|BG002|Baseline|Aspiring >300 mg|Aspirin >300 mg QD
11100341|NCT01586975|BG003|Baseline|Total|Total of all reporting groups
11100342|NCT01586975|FG000|Participant Flow|Clopidogrel 75 mg|Clopidogrel 75 mg QD
11100343|NCT01586975|FG001|Participant Flow|Aspirin 81 mg|Aspirin 81 mg QD
11100344|NCT01586975|FG002|Participant Flow|Aspirin > 300 mg|Aspiring > 300 mg QD
11100345|NCT01586975|OG000|Outcome|Clopidogrel 75 mg|Clopidogrel 75 mg QD
11100346|NCT01586975|OG001|Outcome|Aspirin 81 mg|open label Aspirin
11100347|NCT01586975|OG002|Outcome|Aspirin > 300 mg|open-label Aspirin
11100348|NCT01586975|EG000|Reported Event|Clopidogrel 75 mg|Clopidogrel 75 mg QD
11100349|NCT01586975|EG001|Reported Event|Aspirin 81 mg|Aspirin 81 mg QD
11100350|NCT01586975|EG002|Reported Event|Aspirin >300 mg|Aspirin >300 mg QD
11100351|NCT01587001|BG000|Baseline|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks~N-acetyl-cysteine: 900mg three times daily for 8 weeks"
11100352|NCT01587001|BG001|Baseline|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
11100353|NCT01587001|BG002|Baseline|Total|Total of all reporting groups
11100354|NCT01587001|FG000|Participant Flow|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
11100355|NCT01587001|FG001|Participant Flow|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
11100356|NCT01587001|OG000|Outcome|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
11100357|NCT01587001|OG001|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
11100358|NCT01587001|OG000|Outcome|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks~N-acetyl-cysteine: 900mg three times daily for 8 weeks"
11100359|NCT01587001|EG000|Reported Event|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
11100360|NCT01587001|EG001|Reported Event|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
11100361|NCT01587014|BG000|Baseline|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
11100362|NCT01587014|FG000|Participant Flow|Prima-Temp Monitoring Patch|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
11100363|NCT01587014|OG000|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
11100364|NCT01587014|EG000|Reported Event|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
11100365|NCT01587027|BG000|Baseline|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
11100366|NCT01587027|BG001|Baseline|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
11100367|NCT01587027|BG002|Baseline|Total|Total of all reporting groups
11100368|NCT01587027|FG000|Participant Flow|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
11100369|NCT01587027|FG001|Participant Flow|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
11100370|NCT01587027|OG000|Outcome|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
11100371|NCT01587027|OG001|Outcome|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
11100372|NCT01587027|EG000|Reported Event|Arm A|Aminophylline (1 Day) Washout (1 Day) Methazolamide (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
11100373|NCT01587027|EG001|Reported Event|Arm B|Methazolamide (1 Day) Washout (1 Day) Aminophylline (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
11100374|NCT01587079|BG000|Baseline|All Subjects Screened|
11100375|NCT01587079|FG000|Participant Flow|All Subjects|
11100376|NCT01587079|OG000|Outcome|GP MDI 18 μg (PT001)|18 μg
11100377|NCT01587079|OG001|Outcome|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
11100378|NCT01587079|OG002|Outcome|GFF/MDI 9/9.6 μg|9/9.6 μg
11100379|NCT01587079|OG003|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
11100380|NCT01587079|OG004|Outcome|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
11100381|NCT01587079|OG005|Outcome|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
11100382|NCT01587079|OG006|Outcome|FF MDI 9.6 μg|9.6 μg
11100383|NCT01587079|OG007|Outcome|Spiriva 18 μg QD|18 μg QD
11100384|NCT01587079|OG000|Outcome|GP MDI BID 18 μg|BID 18 μg
11100385|NCT01587079|OG001|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
11100386|NCT01587079|OG002|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
11100387|NCT01587079|OG004|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
11100388|NCT01587079|OG005|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
11100389|NCT01587079|OG006|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
11100390|NCT01587079|OG007|Outcome|GP MDI 18 μg (PT001)|18 μg
11100391|NCT01587079|OG000|Outcome|GP MDI 18 μg BID|18 μg BID
11100392|NCT01587079|OG001|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
11100393|NCT01587079|OG002|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
11100394|NCT01587079|OG004|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
11100395|NCT01587079|OG005|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
11100396|NCT01587079|OG006|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
11100397|NCT01587079|OG003|Outcome|GFF MDI 4.6/9.6 μg BID|4.6/9.6 μg BID
11100398|NCT01587079|OG007|Outcome|Spiriva18 μg QD|18 μg QD
11100399|NCT01587079|OG003|Outcome|GFF MDI BID 4.6/9.6 μg BID|4.6/9.6 μg BID
11100400|NCT01587079|EG000|Reported Event|GP MDI 18 μg (PT001)|18 μg
11100401|NCT01587079|EG001|Reported Event|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
11100402|NCT01587079|EG002|Reported Event|GFF MDI 9/9.6 μg (PT003)|9/9.6 μg
11100403|NCT01587079|EG003|Reported Event|GFF MDI 4.6/9.6 μg (PT003)|4.6/9.6 μg
11100404|NCT01587079|EG004|Reported Event|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
11100405|NCT01587079|EG005|Reported Event|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
11100406|NCT01587079|EG006|Reported Event|FF MDI 9.6 μg (PT005)|9.6 μg
11100407|NCT01587079|EG007|Reported Event|Spiriva|18 μg
11100408|NCT01587105|BG000|Baseline|Control|Usual Care Group
11100409|NCT01587105|BG001|Baseline|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
11100410|NCT01587105|BG002|Baseline|Total|Total of all reporting groups
11100411|NCT01587105|FG000|Participant Flow|Control|Usual Care Group
11100412|NCT01587105|FG001|Participant Flow|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
11100413|NCT01587105|OG000|Outcome|Control|Usual Care Group
11100414|NCT01587105|OG001|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
11100415|NCT01587105|EG000|Reported Event|Control|Usual Care Group
11100416|NCT01587105|EG001|Reported Event|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
11100417|NCT01587118|BG000|Baseline|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
11100418|NCT01587118|FG000|Participant Flow|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
11100419|NCT01587118|OG000|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
11100420|NCT01587118|EG000|Reported Event|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
11100421|NCT01587274|BG000|Baseline|Opioid|"Naproxen + opioid~Naproxen: Naproxen 500mg twice/ day x 10 days~Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days"
11100422|NCT01587274|BG001|Baseline|Skeletal Muscle Relaxant|"Naproxen + skeletal muscle relaxant~Naproxen: Naproxen 500mg twice/ day x 10 days~Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days"
11100423|NCT01587274|BG002|Baseline|Naproxen Alone|"Naproxen + placebo~Naproxen: Naproxen 500mg twice/ day x 10 days"
11100424|NCT01587274|BG003|Baseline|Total|Total of all reporting groups
11100425|NCT01587274|FG000|Participant Flow|Opioid|"Naproxen + opioid~Naproxen: Naproxen 500mg twice/ day x 10 days~Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days"
11100426|NCT01587274|FG001|Participant Flow|Skeletal Muscle Relaxant|"Naproxen + skeletal muscle relaxant~Naproxen: Naproxen 500mg twice/ day x 10 days~Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days"
11100427|NCT01587274|FG002|Participant Flow|Naproxen Alone|"Naproxen + placebo~Naproxen: Naproxen 500mg twice/ day x 10 days"
11100428|NCT01587274|OG000|Outcome|Opioid|"Naproxen + opioid~Naproxen: Naproxen 500mg twice/ day x 10 days~Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days"
11100429|NCT01587274|OG001|Outcome|Skeletal Muscle Relaxant|"Naproxen + skeletal muscle relaxant~Naproxen: Naproxen 500mg twice/ day x 10 days~Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days"
11100430|NCT01587274|OG002|Outcome|Naproxen Alone|"Naproxen + placebo~Naproxen: Naproxen 500mg twice/ day x 10 days"
11100431|NCT01587274|EG000|Reported Event|Opioid|"Naproxen + opioid~Naproxen: Naproxen 500mg twice/ day x 10 days~Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days"
11100432|NCT01587274|EG001|Reported Event|Skeletal Muscle Relaxant|"Naproxen + skeletal muscle relaxant~Naproxen: Naproxen 500mg twice/ day x 10 days~Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days"
11100433|NCT01587274|EG002|Reported Event|Naproxen Alone|"Naproxen + placebo~Naproxen: Naproxen 500mg twice/ day x 10 days"
11100434|NCT01587651|BG000|Baseline|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
11100435|NCT01587651|BG001|Baseline|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
11100436|NCT01587651|BG002|Baseline|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
11100437|NCT01587651|BG003|Baseline|Total|Total of all reporting groups
11100438|NCT01587651|FG000|Participant Flow|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
11100439|NCT01587651|FG001|Participant Flow|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
11100440|NCT01587651|FG002|Participant Flow|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
11100441|NCT01587651|OG000|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
11100442|NCT01587651|OG001|Outcome|Ticagrelor|
11100443|NCT01587651|OG002|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
11100444|NCT01587651|OG003|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
11100445|NCT01587651|EG000|Reported Event|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
11100446|NCT01587651|EG001|Reported Event|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
11100447|NCT01587651|EG002|Reported Event|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
11100448|NCT01587703|BG000|Baseline|Part 1: GSK525762 4 mg QD|Participants were administered once daily oral dose of 4 mg GSK525762
11100449|NCT01587703|BG001|Baseline|Part 1: GSK525762 8 mg QD|Participants were administered once daily oral dose of 8 mg GSK525762.
11100450|NCT01587703|BG002|Baseline|Part 1: GSK525762 16 mg QD|Participants were administered once daily oral dose of 16 mg GSK525762.
11100451|NCT01587703|BG003|Baseline|Part 1: GSK525762 30 mg QD|Participants were administered once daily oral dose of 30 mg GSK525762.
11100452|NCT01587703|BG004|Baseline|Part 1: GSK525762 60 mg QD|Participants were administered once daily oral dose of 60 mg GSK525762.
11100453|NCT01587703|BG005|Baseline|Part 1: GSK525762 80 mg QD|Participants were administered once daily oral dose of 80 mg GSK525762.
11100454|NCT01587703|BG006|Baseline|Part 1: GSK525762 100 mg QD|Participants were administered once daily oral dose of 100 mg GSK525762.
11100455|NCT01587703|BG007|Baseline|Part 1: GSK525762 20 mg BID|Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
11100456|NCT01587703|BG008|Baseline|Part 1: GSK525762 30 mg BID|Participants were administered twice daily oral dose of 30 mg GSK525762.
11100457|NCT01587703|BG009|Baseline|Part 1: GSK525762 40 mg BID|Participants were administered twice daily oral dose of 40 mg GSK525762.
11100458|NCT01587703|BG010|Baseline|All Participants in Besylate Substudy|All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
11100459|NCT01587703|BG011|Baseline|Part 2: Participants With NMC|Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100460|NCT01587703|BG012|Baseline|Part 2: Participants With SCLC|Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
11100461|NCT01587703|BG013|Baseline|Part 2: Participants With CRPC|Participants with Castrate-Resistant Prostate Cancer (CRPR) were administered continuous once daily oral dose of 75 mg GSK525762
11100462|NCT01587703|BG014|Baseline|Part 1: GSK525762 2 mg QD|Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
11100463|NCT01587703|BG015|Baseline|Part 2: Participants With TNBC|Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
10845990|NCT00271856|EG000|Reported Event|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
11100464|NCT01587703|BG016|Baseline|Part 2: Participants With ER+BC|Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
11100465|NCT01587703|BG017|Baseline|Part 2: Participants With GIST|Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
11100466|NCT01587703|BG018|Baseline|Total|Total of all reporting groups
11100467|NCT01587703|FG000|Participant Flow|Part 1: GSK525762 2 mg QD|Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
11100468|NCT01587703|FG001|Participant Flow|Part 1: GSK525762 4 mg QD|Participants were administered once daily oral dose of 4 mg GSK525762
11100469|NCT01587703|FG002|Participant Flow|Part 1: GSK525762 8 mg QD|Participants were administered once daily oral dose of 8 mg GSK525762.
11100470|NCT01587703|FG003|Participant Flow|Part 1: GSK525762 16 mg QD|Participants were administered once daily oral dose of 16 mg GSK525762.
11100471|NCT01587703|FG004|Participant Flow|Part 1: GSK525762 30 mg QD|Participants were administered once daily oral dose of 30 mg GSK525762.
11100472|NCT01587703|FG005|Participant Flow|Part 1: GSK525762 60 mg QD|Participants were administered once daily oral dose of 60 mg GSK525762.
11100473|NCT01587703|FG006|Participant Flow|Part 1: GSK525762 80 mg QD|Participants were administered once daily oral dose of 80 mg GSK525762.
11100474|NCT01587703|FG007|Participant Flow|Part 1: GSK525762 100 mg QD|Participants were administered once daily oral dose of 100 mg GSK525762.
11100475|NCT01587703|FG008|Participant Flow|Part 1: GSK525762 20 mg BID|Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
11100476|NCT01587703|FG009|Participant Flow|Part 1: GSK525762 30 mg BID|Participants were administered twice daily oral dose of 30 mg GSK525762.
11100477|NCT01587703|FG010|Participant Flow|Part 1: GSK525762 40 mg BID|Participants were administered twice daily oral dose of 40 mg GSK525762.
11100478|NCT01587703|FG011|Participant Flow|Part 2: Participants With NMC|Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100479|NCT01587703|FG012|Participant Flow|Part 2: Participants With SCLC|Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
11100480|NCT01587703|FG013|Participant Flow|Part 2: Participants With CRPC|Participants with Castrate-Resistant Prostate Cancer (CRPR) were administered continuous once daily oral dose of 75 mg GSK525762
11100481|NCT01587703|FG014|Participant Flow|Part 2: Participants With TNBC|Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100482|NCT01587703|FG015|Participant Flow|Part 2: Participants With ER+BC|Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
11100483|NCT01587703|FG016|Participant Flow|Part 2: Participants With GIST|Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
11100484|NCT01587703|FG017|Participant Flow|80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes|Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
11100485|NCT01587703|FG018|Participant Flow|80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes|Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
11100486|NCT01587703|OG000|Outcome|Part 1: GSK525762 2 mg QD|Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
11100487|NCT01587703|OG001|Outcome|Part 1: GSK525762 4 mg QD|Participants were administered once daily oral dose of 4 mg GSK525762
11100488|NCT01587703|OG002|Outcome|Part 1: GSK525762 8 mg QD|Participants were administered once daily oral dose of 8 mg GSK525762.
11100489|NCT01587703|OG003|Outcome|Part 1: GSK525762 16 mg QD|Participants were administered once daily oral dose of 16 mg GSK525762.
11100490|NCT01587703|OG004|Outcome|Part 1: GSK525762 30 mg QD|Participants were administered once daily oral dose of 30 mg GSK525762.
11100491|NCT01587703|OG005|Outcome|Part 1: GSK525762 60 mg QD|Participants were administered once daily oral dose of 60 mg GSK525762.
11100492|NCT01587703|OG006|Outcome|Part 1: GSK525762 80 mg QD|Participants were administered once daily oral dose of 80 mg GSK525762.
11100493|NCT01587703|OG007|Outcome|Part 1: GSK525762 100 mg QD|Participants were administered once daily oral dose of 100 mg GSK525762.
11100494|NCT01587703|OG000|Outcome|Part 1: GSK525762 20 mg BID|Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
11100495|NCT01587703|OG001|Outcome|Part 1: GSK525762 30 mg BID|Participants were administered twice daily oral dose of 30 mg GSK525762.
11100496|NCT01587703|OG002|Outcome|Part 1: GSK525762 40 mg BID|Participants were administered twice daily oral dose of 40 mg GSK525762.
11100497|NCT01587703|OG000|Outcome|Participants With NMC|Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762
11100498|NCT01587703|OG001|Outcome|Participants With SCLC|Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
11100499|NCT01587703|OG002|Outcome|Participants With CRPC|Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762
11100500|NCT01587703|OG003|Outcome|Participants With TNBC|Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762
11100501|NCT01587703|OG004|Outcome|Participants With ER+BC|Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
11100502|NCT01587703|OG005|Outcome|Participants With GIST|Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
11100503|NCT01587703|OG001|Outcome|Part 1: GSK525762 4 mg QD|Participants were administered once daily oral dose of 4 mg GSK525762.
11100504|NCT01587703|OG000|Outcome|80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes|Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
11100505|NCT01587703|OG001|Outcome|80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes|Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
11100506|NCT01587703|OG000|Outcome|Part 1: GSK525762 20 mg BID|Participants were administered twice daily oral dose of 20 mg GSK525762.
11100507|NCT01587703|OG000|Outcome|Part 2: Participants With NMC|Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100508|NCT01587703|OG001|Outcome|Part 2: Participants With SCLC|Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100509|NCT01587703|OG002|Outcome|Part 2: Participants With CRPC|Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100510|NCT01587703|OG003|Outcome|Part 2: Participants With TNBC|Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100511|NCT01587703|OG004|Outcome|Part 2: Participants With ER+BC|Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100512|NCT01587703|OG005|Outcome|Part 2: Participants With GIST|Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
11100513|NCT01587703|OG002|Outcome|Part 1: GSK525762 40 mg BID|Participants were administered once daily oral dose of 40 mg GSK525762.
11100514|NCT01587703|OG000|Outcome|Part 1: GSK525762 2 mg QD|Participants were administered once daily (QD) oral dose of 2 illigrams (mg) GSK525762.
11100515|NCT01587703|OG000|Outcome|All Participants in Besylate Substudy|All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
11100516|NCT01587703|OG000|Outcome|GSK525762 80 mg Amorphous+6 mg Stable Isotope|Participants were administered GSK525762 80 mg amorphous free-base tablet along with 6 mg stable isotope in the fasted state.
11100517|NCT01587703|OG001|Outcome|GSK525762 80 mg Besylate+6 mg Stable Isotope|Participants were administered GSK525762 80 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.
11100518|NCT01587703|OG002|Outcome|GSK525762 30 mg Besylate+6 mg Stable Isotope|Participants were administered GSK525762 30 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.
11100519|NCT01587703|OG003|Outcome|GSK525762 80 mg Besylate Fed|Participants were administered GSK525762 80 mg besylate tablet along with Food and Drug Administration (FDA) recommended high fat breakfast.
11100520|NCT01587703|OG002|Outcome|Part 1: GSK525762 8 mg QD|Participants were administered once daily oral dose of 8 mg GSK525762
11100521|NCT01587703|OG003|Outcome|Part 1: GSK525762 16 mg QD|Participants were administered once daily oral dose of 16 mg GSK525762
11100522|NCT01587703|OG000|Outcome|Part 1: GSK525762 2 mg QD|Participants were administered once daily (QD) oral dose of 2 milligrams(mg) GSK525762
11100523|NCT01587703|OG000|Outcome|Part 1: GSK525762 2 mg QD|Participants were administered once daily oral dose of 2 mg GSK525762.
11100524|NCT01587703|EG000|Reported Event|Part1: GSK525762 4 mg QD|Participants were administered once daily oral dose of 4 mg GSK525762.
11100525|NCT01587703|EG001|Reported Event|Part 1: GSK525762 8 mg QD|Participants were administered once daily oral dose of 8 mg GSK525762.
11100526|NCT01587703|EG002|Reported Event|Part 1: GSK525762 16 mg QD|Participants were administered once daily oral dose of 16 mg GSK525762.
11100527|NCT01587703|EG003|Reported Event|Part 1: GSK525762 30 mg QD|Participants were administered once daily oral dose of 30 mg GSK525762.
11100528|NCT01587703|EG004|Reported Event|Part 1: GSK525762 60 mg QD|Participants were administered once daily oral dose of 60 mg GSK525762.
11100529|NCT01587703|EG005|Reported Event|Part 1: GSK525762 80 mg QD|Participants were administered once daily oral dose of 80 mg GSK525762.
11100530|NCT01587703|EG006|Reported Event|Part 1: GSK525762 100 mg QD|Participants were administered once daily oral dose of 100 mg GSK525762.
11100531|NCT01587703|EG007|Reported Event|Part 1: GSK525762 20 mg BID|Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
11100532|NCT01587703|EG008|Reported Event|Part 1: GSK525762 30 mg BID|Participants were administered twice daily oral dose of 30 mg GSK525762.
11100533|NCT01587703|EG009|Reported Event|Part 1: GSK525762 40 mg BID|Participants were administered twice daily oral dose of 40 mg GSK525762.
11100534|NCT01587703|EG010|Reported Event|Part 2: Participants With NMC|Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100535|NCT01587703|EG011|Reported Event|Part 2: Participants With SCLC|Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100536|NCT01587703|EG012|Reported Event|Part 2: Participants With CRPC|Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100537|NCT01587703|EG013|Reported Event|Part1: GSK525762 2 mg QD|Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
11100538|NCT01587703|EG014|Reported Event|Part 2: Participants With TNBC|Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100539|NCT01587703|EG015|Reported Event|Part 2: Participants With ER+BC|Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.
11100540|NCT01587703|EG016|Reported Event|Part 2: Participants With GIST|Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
11100541|NCT01587703|EG017|Reported Event|80mg Amor+6mg Iso/80mg Bes+6mg|Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
11100542|NCT01587703|EG018|Reported Event|80mg Bes+6mg Iso/80mg Amor+6mg|Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
11100543|NCT01587885|BG000|Baseline|All Participants|All participants who were randomized and received study drug.
11100544|NCT01587885|FG000|Participant Flow|Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
11100545|NCT01587885|FG001|Participant Flow|Omeprazole 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
11100546|NCT01587885|OG000|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
11100547|NCT01587885|OG001|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
11100548|NCT01587885|OG000|Outcome|All Treated Participants|
11100549|NCT01587885|EG000|Reported Event|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
11100550|NCT01587885|EG001|Reported Event|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
11100551|NCT01587898|BG000|Baseline|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100552|NCT01587898|BG001|Baseline|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100553|NCT01587898|BG002|Baseline|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100554|NCT01587898|BG003|Baseline|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100555|NCT01587898|BG004|Baseline|Total|Total of all reporting groups
11100556|NCT01587898|FG000|Participant Flow|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100557|NCT01587898|FG001|Participant Flow|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 milligram (mg) tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100558|NCT01587898|FG002|Participant Flow|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100559|NCT01587898|FG003|Participant Flow|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100560|NCT01587898|OG000|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100561|NCT01587898|OG001|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
10845991|NCT00271856|EG001|Reported Event|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
10845992|NCT00272038|BG000|Baseline|Tarceva|Tarceva 150 mg QD
11100562|NCT01587898|OG002|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100563|NCT01587898|OG003|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100564|NCT01587898|OG000|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100565|NCT01587898|OG001|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100566|NCT01587898|OG002|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100567|NCT01587898|EG000|Reported Event|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100568|NCT01587898|EG001|Reported Event|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100569|NCT01587898|EG002|Reported Event|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100570|NCT01587898|EG003|Reported Event|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
11100571|NCT01587924|BG000|Baseline|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
11100572|NCT01587924|BG001|Baseline|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
11100573|NCT01587924|BG002|Baseline|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
11100574|NCT01587924|BG003|Baseline|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
11100575|NCT01587924|BG004|Baseline|Total|Total of all reporting groups
11100576|NCT01587924|FG000|Participant Flow|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 milligrams (mg) once daily for 4 weeks and we re followed-up for 2 weeks
11100577|NCT01587924|FG001|Participant Flow|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
11100578|NCT01587924|FG002|Participant Flow|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
11100579|NCT01587924|FG003|Participant Flow|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
11100580|NCT01587924|OG000|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
11100581|NCT01587924|OG001|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
11100582|NCT01587924|OG002|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
11100583|NCT01587924|OG003|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
11100584|NCT01587924|EG000|Reported Event|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 milligrams (mg) once daily for 4 weeks and we re followed-up for 2 weeks
10845993|NCT00272038|FG000|Participant Flow|Tarceva|Tarceva 150 mg orally every day
10845994|NCT00272038|OG000|Outcome|Tarceva|Tarceva 150 mg QD
10845995|NCT00272038|OG000|Outcome|Tarceva|"Tarceva 150 mg QD~Tarceva: 150mg QD"
11100585|NCT01587924|EG001|Reported Event|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
11100586|NCT01587924|EG002|Reported Event|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
11100587|NCT01587924|EG003|Reported Event|rhEPO|Eligible participants received oral recombinant human erythropoietin (rhEPO ) or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
11100588|NCT01587950|BG000|Baseline|Overall|All randomized participants received all study treatments during this cross over study design.
11100589|NCT01587950|FG000|Participant Flow|Overall|There were six study treatment regimens- 5% Potassium nitrate (KNO3) 250μl applied to an individual tooth once for 2, 5 or 10 min; 2.5% KNO3 (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Three reference treatment regimens were sterile water (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Each participant received 9 treatment regimens over three treatment visits. Three individual teeth were treated at each treatment visit. Each treatment visit was one day in length. A washout of 4 days was given after each treatment visit. Study duration for each participant during this efficacy analysis phase was approximately 5 weeks
11100590|NCT01587950|OG000|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
11100591|NCT01587950|OG001|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
11100592|NCT01587950|OG002|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
11100593|NCT01587950|OG003|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
11100594|NCT01587950|OG004|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
11100595|NCT01587950|OG005|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
11100596|NCT01587950|OG006|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
11100597|NCT01587950|OG007|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
11100598|NCT01587950|OG008|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
11100599|NCT01587950|OG001|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth sensitive tooth once for 2 minutes during each treatment period.
11100600|NCT01587950|EG000|Reported Event|Overall|All participants received all study treatments during this cross over study design.
11100601|NCT01587989|BG000|Baseline|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
11100602|NCT01587989|BG001|Baseline|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
11100603|NCT01587989|BG002|Baseline|Total|Total of all reporting groups
11100604|NCT01587989|FG000|Participant Flow|All Participants|Participants received TCZ 8 milligrams per kilogram (mg/kg), intravenously (IV), every 4 weeks, from Weeks 1-12. Participants also received MTX 15 milligrams per week (mg/week) to 25 mg/week at a stable dose, orally (PO) as tablets, once per week, from Weeks 1-12. Participants also received folic acid, greater than or equal to (≥) 5 mg/week, PO, from Weeks 1-12. Participants also received non-sterioidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to [≤] 10 milligrams per day [mg/day] prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-12. At Week 12 participants who had achieved a good or moderate European League Against Rheumatism (EULAR) response were randomized to receive TCZ plus (+) continued MTX treatment or TCZ + placebo. Participants without a good or moderate EULAR response were excluded from the study and treated according to the standard of care of the treatment site.
11100605|NCT01587989|FG001|Participant Flow|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
11100606|NCT01587989|FG002|Participant Flow|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
11100607|NCT01587989|OG000|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
10845996|NCT00272038|EG000|Reported Event|Tarceva|Tarceva 150 mg QD
10878601|NCT00453349|OG001|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
11100608|NCT01587989|OG001|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
11100609|NCT01587989|EG000|Reported Event|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
11100610|NCT01587989|EG001|Reported Event|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
11100611|NCT01588106|BG000|Baseline|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
11100612|NCT01588106|BG001|Baseline|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
11100613|NCT01588106|BG002|Baseline|Total|Total of all reporting groups
11100614|NCT01588106|FG000|Participant Flow|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
11100615|NCT01588106|FG001|Participant Flow|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
11100616|NCT01588106|OG000|Outcome|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
11100617|NCT01588106|OG001|Outcome|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
11100618|NCT01588106|EG000|Reported Event|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
11100619|NCT01588106|EG001|Reported Event|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
11100620|NCT01588158|BG000|Baseline|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
11100621|NCT01588158|BG001|Baseline|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
11100622|NCT01588158|BG002|Baseline|Total|Total of all reporting groups
11100623|NCT01588158|FG000|Participant Flow|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
11100624|NCT01588158|FG001|Participant Flow|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
11100625|NCT01588158|OG000|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
11100626|NCT01588158|OG001|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
11100627|NCT01588158|EG000|Reported Event|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
11100628|NCT01588158|EG001|Reported Event|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
11100629|NCT01588184|BG000|Baseline|Breast Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100630|NCT01588184|BG001|Baseline|Ovarian Cancer or Peritoneal Carcinoma|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100631|NCT01588184|BG002|Baseline|Colorectal Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
10878602|NCT00453349|EG000|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
11100632|NCT01588184|BG003|Baseline|Renal Cell Carcinoma|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100633|NCT01588184|BG004|Baseline|Non-Squamous, Non-Small Cell Lung Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100634|NCT01588184|BG005|Baseline|Glioblastoma Multiforme|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100635|NCT01588184|BG006|Baseline|Total|Total of all reporting groups
11100636|NCT01588184|FG000|Participant Flow|Breast Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100637|NCT01588184|FG001|Participant Flow|Ovarian Cancer or Peritoneal Carcinoma|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100638|NCT01588184|FG002|Participant Flow|Colorectal Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100639|NCT01588184|FG003|Participant Flow|Renal Cell Carcinoma|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100640|NCT01588184|FG004|Participant Flow|Non-Squamous, Non-Small Cell Lung Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100641|NCT01588184|FG005|Participant Flow|Glioblastoma Multiforme|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100642|NCT01588184|OG000|Outcome|Breast Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100643|NCT01588184|OG001|Outcome|Ovarian Cancer or Peritoneal Carcinoma|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100644|NCT01588184|OG002|Outcome|Colorectal Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100645|NCT01588184|OG003|Outcome|Renal Cell Carcinoma|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100646|NCT01588184|OG004|Outcome|Non-Squamous, Non-Small Cell Lung Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100647|NCT01588184|OG005|Outcome|Glioblastoma Multiforme|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100648|NCT01588184|EG000|Reported Event|Breast Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100649|NCT01588184|EG001|Reported Event|Ovarian Cancer or Peritoneal Carcinoma|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100650|NCT01588184|EG002|Reported Event|Colorectal Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100651|NCT01588184|EG003|Reported Event|Renal Cell Carcinoma|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100652|NCT01588184|EG004|Reported Event|Non-Squamous, Non-Small Cell Lung Cancer|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100653|NCT01588184|EG005|Reported Event|Glioblastoma Multiforme|Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
11100654|NCT01588197|BG000|Baseline|ACC Real Time fMRI Feedback|"Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy.~The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the rACC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display."
11100655|NCT01588197|BG001|Baseline|PFC Real Time fMRI Feedback|"Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy.~The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the PFC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display."
11100656|NCT01588197|BG002|Baseline|Total|Total of all reporting groups
11100657|NCT01588197|FG000|Participant Flow|ACC Real Time fMRI Feedback|"Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy.~The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the rACC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display."
10878603|NCT00453349|EG001|Reported Event|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
11100658|NCT01588197|FG001|Participant Flow|PFC Real Time fMRI Feedback|"Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy.~The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the PFC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display."
11100659|NCT01588197|OG000|Outcome|ACC Real Time fMRI Feedback|"Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy.~The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the rACC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display."
11100660|NCT01588197|OG001|Outcome|PFC Real Time fMRI Feedback|"Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy.~The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the PFC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display."
11100661|NCT01588197|EG000|Reported Event|Real Time fMRI Feedback|"Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode. They will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy. Half of the participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the rACC and PFC after each pain/rest block."
11100662|NCT01588197|EG001|Reported Event|No Feedback|"Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode. They will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy. Randomly assigned to receive no feedback in the form of two empty thermometer images on the in-scanner computer display."
11100663|NCT01588236|BG000|Baseline|KYG0395 (High Dose Group)|KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
11100664|NCT01588236|BG001|Baseline|KYG0395 (Lower Dose Group)|KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
11100665|NCT01588236|BG002|Baseline|Placebo|placebo: 3 capsules of placebo tid (morning, midday, and evening)
11100666|NCT01588236|BG003|Baseline|Total|Total of all reporting groups
11100667|NCT01588236|FG000|Participant Flow|KYG0395 (High Dose Group)|KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
11100668|NCT01588236|FG001|Participant Flow|KYG0395 (Lower Dose Group)|KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
11100669|NCT01588236|FG002|Participant Flow|Placebo|placebo: 3 capsules of placebo tid (morning, midday, and evening)
11100670|NCT01588236|OG000|Outcome|KYG0395 (High Dose Group)|KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
11100671|NCT01588236|OG001|Outcome|KYG0395 (Lower Dose Group)|KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
11100672|NCT01588236|OG002|Outcome|Placebo|placebo: 3 capsules of placebo tid (morning, midday, and evening)
11100673|NCT01588236|EG000|Reported Event|KYG0395 (High Dose Group)|KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
11100674|NCT01588236|EG001|Reported Event|KYG0395 (Lower Dose Group)|KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
11100675|NCT01588236|EG002|Reported Event|Placebo|placebo: 3 capsules of placebo tid (morning, midday, and evening)
11100676|NCT01588353|BG000|Baseline|AK160 0.58 mg Step 1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.~And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
11100677|NCT01588353|BG001|Baseline|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
11100678|NCT01588353|BG002|Baseline|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.~This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
11100679|NCT01588353|BG003|Baseline|Total|Total of all reporting groups
11126408|NCT01733186|OG001|Outcome|Dose B Cohort|"Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect~Cartilage defect size range: above 5 cm2 (Dose B)~CARTISTEM®"
11100680|NCT01588353|FG000|Participant Flow|AK160 0.58 mg Step1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.~And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
11100681|NCT01588353|FG001|Participant Flow|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
11100682|NCT01588353|FG002|Participant Flow|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.~This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
11100683|NCT01588353|OG000|Outcome|AK160 0.58 mg Step 1-2|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
11100684|NCT01588353|OG000|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
11100685|NCT01588353|OG001|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
11100686|NCT01588353|OG002|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
11100687|NCT01588353|EG000|Reported Event|AK160 0.58 mg Step 1-3|Collagenase Clostridium Histolyticum: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
11100688|NCT01588366|BG000|Baseline|Placebo - Healthy (Part A)|Placebo administered orally, QD for 28 days to healthy participants.
11100689|NCT01588366|BG001|Baseline|60 mg LY2409021 - Healthy (Part A)|60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
11100690|NCT01588366|BG002|Baseline|Placebo - T2DM (Parts A and B)|Placebo administered orally, QD for 28 days to participants with T2DM.
11100691|NCT01588366|BG003|Baseline|15 mg LY2409021 - T2DM (Part B)|15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100692|NCT01588366|BG004|Baseline|60 mg LY2409021 - T2DM (Part A)|60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100693|NCT01588366|BG005|Baseline|Total|Total of all reporting groups
11100694|NCT01588366|FG000|Participant Flow|Placebo - Healthy (Part A)|Placebo administered orally, once daily (QD) for 28 days to healthy participants.
11100695|NCT01588366|FG001|Participant Flow|60 mg LY2409021 - Healthy (Part A)|60 milligrams (mg) LY2409021 administered orally, QD for 28 days to healthy participants.
11100696|NCT01588366|FG002|Participant Flow|Placebo - T2DM (Part A)|Placebo administered orally, QD for 28 days to participants with type 2 diabetes mellitus (T2DM).
11100697|NCT01588366|FG003|Participant Flow|60 mg LY2409021 - T2DM (Part A)|60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100698|NCT01588366|FG004|Participant Flow|Placebo - T2DM (Part B)|Placebo administered orally, QD for 28 days to participants with T2DM.
11100699|NCT01588366|FG005|Participant Flow|15 mg LY2409021 - T2DM (Part B)|15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100700|NCT01588366|OG000|Outcome|Placebo - Healthy (Part A)|Placebo administered orally, QD for 28 days to healthy participants.
11100701|NCT01588366|OG001|Outcome|60 mg LY2409021 - Healthy (Part A)|60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
11100702|NCT01588366|OG002|Outcome|Placebo - T2DM (Parts A and B)|Placebo administered orally, QD for 28 days to participants with T2DM.
11100703|NCT01588366|OG003|Outcome|15 mg LY2409021 - T2DM (Part B)|15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100704|NCT01588366|OG004|Outcome|60 mg LY2409021 - T2DM (Part A)|60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100705|NCT01588366|OG000|Outcome|60 mg LY2409021 - Healthy (Part A)|60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
11100706|NCT01588366|OG001|Outcome|60 mg LY2409021 - T2DM (Part A)|60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100707|NCT01588366|OG000|Outcome|60 mg LY2409021 (Healthy)|Part A: 60 mg LY2409021 administered orally, QD, for 28 days in healthy participants.
11100708|NCT01588366|OG001|Outcome|60 mg LY2409021 (T2DM)|Part B: 60 mg LY2409021 administered orally, QD for 28 days in participants with T2DM.
11100709|NCT01588366|EG000|Reported Event|Placebo - Healthy (Part A)|Placebo administered orally, QD for 28 days to healthy participants.
11100710|NCT01588366|EG001|Reported Event|60 mg LY2409021 - Healthy (Part A)|60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
11100711|NCT01588366|EG002|Reported Event|Placebo - T2DM (Parts A and B)|Placebo administered orally, QD for 28 days to participants with T2DM.
11100712|NCT01588366|EG003|Reported Event|15 mg LY2409021 - T2DM (Part B)|15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100713|NCT01588366|EG004|Reported Event|60 mg LY2409021 - T2DM (Part A)|60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
11100714|NCT01588405|BG000|Baseline|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
11224505|NCT02360475|BG002|Baseline|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11100715|NCT01588405|FG000|Participant Flow|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
11100716|NCT01588405|OG000|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
11100717|NCT01588405|OG000|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
11100718|NCT01588405|OG001|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
11100719|NCT01588405|OG002|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
11100720|NCT01588405|EG000|Reported Event|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
11100721|NCT01588418|BG000|Baseline|PET With Exenatide vs Placebo Injection|"All subjects will receive the same intervention with Exenatide and placebo. Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study).~In the first study IGT male subjects will be randomized to exenatide or placebo injection before OGTT-PET study. In the second study the same subjects will receive placebo or exenatide respectively before OGTT-PET study. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject."
11100722|NCT01588418|FG000|Participant Flow|OGTT-PET: Exenatide First Then Placebo|In the first study subjects received exenatide 5ug injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received placebo injection before OGTT-PET
11100723|NCT01588418|FG001|Participant Flow|OGTT-PET: Placebo First, Then Exenatide|In the first study subjects received placebo injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received exenatide injection (5ug) before OGTT-PET
11100724|NCT01588418|OG000|Outcome|Effect of Exenatide or Placebo on CMRglu|Brain glucose metabolism (CMRglu) during OGTT measured by PET w/ or w/out Exenatide injection
11100725|NCT01588418|OG000|Outcome|Exenatide First, Then Placebo|"Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.~Exenatide: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study~Placebo: Placebo was administered in random order 30 min before OGTT-PET study in the same subject"
11100726|NCT01588418|OG001|Outcome|Placebo First, Then Exenatide|"Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .~Exenatide: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study~Placebo: Placebo was administered in random order 30 min before OGTT-PET study in the same subject"
11100727|NCT01588418|EG000|Reported Event|PET With Exenatide or Placebo Injection|This is a crossover study where all subjects received the same intervention with Exenatide and placebo, acutely in random order, (i.e. first or second before OGTT-PET study).
11100728|NCT01588444|BG000|Baseline|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
11100729|NCT01588444|BG001|Baseline|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
11100730|NCT01588444|BG002|Baseline|Total|Total of all reporting groups
11100731|NCT01588444|FG000|Participant Flow|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
11100732|NCT01588444|FG001|Participant Flow|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
11100733|NCT01588444|OG000|Outcome|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
11100734|NCT01588444|OG001|Outcome|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
11100735|NCT01588444|EG000|Reported Event|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
11100736|NCT01588444|EG001|Reported Event|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
11100737|NCT01588457|BG000|Baseline|Randomization to Divalproex|Subjects randomized to Divalproex at Randomization 1. Demographics were only tracked in the Randomization 1 phase.
11100738|NCT01588457|BG001|Baseline|Randomization to Lithium|Subjects randomized to Lithium at Randomization 1. Demographics were only tracked in the Randomization 1 phase.
11100739|NCT01588457|BG002|Baseline|Total|Total of all reporting groups
11100740|NCT01588457|FG000|Participant Flow|Randomization to Lithium|Subjects enrolled will be randomized to one of two mood stabilizers, Lithium (Li) or Divalproex (Div) in Randomization 1. If subjects show no symptoms, they will complete at the end of this phase of treatment.
11100741|NCT01588457|FG001|Participant Flow|Randomization to Divalproex|Subjects enrolled will be randomized to one of two mood stabilizers, Lithium (Li) or Divalproex (Div) in Randomization 1. If subjects show no symptoms, they will complete at the end of this phase of treatment.
11100742|NCT01588457|FG002|Participant Flow|Monotherapy Li or Div Plus Quetiapine|Subjects who were on Li or Div and developed symptoms of depression had Quetiapine added to their treatment regimen
11100743|NCT01588457|FG003|Participant Flow|Monotherapy Li or Div Plus Lamotrigine|Subjects who were on monotherapy Li or Div who developed symptoms of depression had Lamotrigine added to their regimen
11100744|NCT01588457|OG000|Outcome|Divalproex After Randomization 1|After a washout period of up to 1 week, subjects will be openly randomized to treatment Divalproex for 2 weeks. Subjects who become intolerant to or divalproex at any point will be crossed over to the other mood stabilizer (Lithium) and continued in the study.
11100745|NCT01588457|OG001|Outcome|Lithium After Randomization 1|After a washout period of up to 1 week, subjects will be openly randomized to treatment Lithium for 2 weeks. Subjects who become intolerant to or Lithium at any point will be crossed over to the other mood stabilizer (Divalproex) and continued in the study.
11100746|NCT01588457|OG002|Outcome|Divalproex or Lithium Monotherapy|Group which continued monotherapy or divalproex after Randomization 2
11100747|NCT01588457|OG003|Outcome|Lithium or Divalproex Plus Quetiapine|Group which had Quetiapine added to Lithium of Divalproex
11100748|NCT01588457|OG004|Outcome|Lithium or Divalproex Plus Lamotrigine|Group which had Lamotrigine added to Lithium or Quetiapine
11100749|NCT01588457|OG000|Outcome|Divalproex After Randomization 1|After a washout period of up to 1 week, subjects will be openly randomized to Divalproex. Subjects who become intolerant to Divalproex at any point will be crossed over to the other mood stabilizer (Lithium) and continued in the study.
11100750|NCT01588457|OG001|Outcome|Lithium After Randomization 1|After a washout period of up to 1 week, subjects will be openly randomized to Lithium. Subjects who become intolerant to or lithium at any point will be crossed over to the other mood stabilizer (divalproex) and continued in the study.
11100751|NCT01588457|OG002|Outcome|Divalproex or Lithium Monotherapy|Group which continued monotherapy on Divalproex or Lithium
11100752|NCT01588457|OG003|Outcome|Lithium or Divalproex Plus Quetiapine|Group which had Quetiapine added to Lithium or Divalproex
11100753|NCT01588457|OG004|Outcome|Lithium or Divalproex Plus Lamotrigine|Group which had Lamotrigine added to Lithium or Divalproex
11100754|NCT01588457|OG000|Outcome|Bipolar Type 1 Divalproex Group|Percentage of Bipolar Type 1 included in Randomization 1
11100755|NCT01588457|OG001|Outcome|Bipolar Type II Divalproex Group|Percentage of Bipolar Type II included in Randomization 1
11100756|NCT01588457|OG002|Outcome|Bipolar Type 1 Lithium Group|Percentage of Bipolar Type 1 included in Randomization 1
11100757|NCT01588457|OG003|Outcome|Bipolar Type II Lithium Group|Percentage of Bipolar Type II included in Randomization 1
11100758|NCT01588457|OG000|Outcome|Divalproex|Subjects randomized to Divalproex at the first randomization
11100759|NCT01588457|OG001|Outcome|Lithium|Subjects randomized to Lithium at the first randomization.
11100760|NCT01588457|EG000|Reported Event|Divalproex|After a washout period of up to 1 week, subjects will be openly randomized to treatment Divalproex for 2 weeks. Subjects who become intolerant to or divalproex at any point will be crossed over to the other mood stabilizer (Lithium) and continued in the study. Adverse events were not collected for Randomization 2.
11100761|NCT01588457|EG001|Reported Event|Lithium|After a washout period of up to 1 week, subjects will be openly randomized to treatment Lithium for 2 weeks. Subjects who become intolerant to or Lithium at any point will be crossed over to the other mood stabilizer (Divalproex) and continued in the study. Adverse events were not collected for Randomization 2.
11100762|NCT01588470|BG000|Baseline|Pioglitazone|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
11100763|NCT01588470|FG000|Participant Flow|Pioglitazone|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone : 45 mg per day for 6 months"
11100764|NCT01588470|OG000|Outcome|Baseline|"Measure of E to A Ratio to determine which subjects will receive~pioglitazone: 45 mg per day for 6 months"
11100765|NCT01588470|OG001|Outcome|E to A Ratio After Pioglitazone Treatment|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
11100766|NCT01588470|OG000|Outcome|Baseline|Only subjects with T2DM or non-diabetic subjects with coronary heart disease measurement of Myocardial Glucose Uptake (MGU) at before Pioglitazone administration.
11100767|NCT01588470|OG001|Outcome|Pioglitazone|Subjects with T2DM or non-diabetic subjects with coronary heart disease who received Pioglitazone -45 mg per day for 6 months
11100768|NCT01588470|OG000|Outcome|Baseline|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
11100769|NCT01588470|OG001|Outcome|Pioglitazone|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
11100770|NCT01588470|EG000|Reported Event|Pioglitazone|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
11100771|NCT01588496|BG000|Baseline|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
11100772|NCT01588496|BG001|Baseline|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
11100773|NCT01588496|BG002|Baseline|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
11100774|NCT01588496|BG003|Baseline|Total|Total of all reporting groups
11100775|NCT01588496|FG000|Participant Flow|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
11100776|NCT01588496|FG001|Participant Flow|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
11100777|NCT01588496|FG002|Participant Flow|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
11100778|NCT01588496|OG000|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
11100779|NCT01588496|OG000|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
11100780|NCT01588496|OG001|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
11100781|NCT01588496|EG000|Reported Event|Part A: OL Evolocumab|Participants received open-label (OL) evolocumab 420 mg subcutaneously once a month for 12 weeks.
11100782|NCT01588496|EG001|Reported Event|Part B: DB Placebo|Participants received double-blind (DB) placebo subcutaneously once a month for 12 weeks.
11100783|NCT01588496|EG002|Reported Event|Part B: DB Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
11100784|NCT01588509|BG000|Baseline|Romosozumab 140 mg|Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
11100785|NCT01588509|BG001|Baseline|Romosozumab 210 mg|Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
11100786|NCT01588509|BG002|Baseline|Total|Total of all reporting groups
11100787|NCT01588509|FG000|Participant Flow|Romosozumab 140 mg|Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
11100788|NCT01588509|FG001|Participant Flow|Romosozumab 210 mg|Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
11100789|NCT01588509|OG000|Outcome|Romosozumab 140 mg|Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
11100790|NCT01588509|OG001|Outcome|Romosozumab 210 mg|Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
11100791|NCT01588509|EG000|Reported Event|Romosozumab 140 mg|Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
11100792|NCT01588509|EG001|Reported Event|Romosozumab 210 mg|Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
11100793|NCT01588548|BG000|Baseline|AZD1208 120mg|Once daily continuous dosing schedule.
11100794|NCT01588548|BG001|Baseline|AZD1208 240mg|Once daily continuous dosing schedule.
11100795|NCT01588548|BG002|Baseline|AZD1208 360mg|Once daily continuous dosing schedule.
11100796|NCT01588548|BG003|Baseline|AZD1208 540mg|Once daily continuous dosing schedule.
11100797|NCT01588548|BG004|Baseline|AZD1208 700mg|Once daily continuous dosing schedule.
11100798|NCT01588548|BG005|Baseline|AZD1208 800mg|Once daily continuous dosing schedule.
11100799|NCT01588548|BG006|Baseline|Total|Total of all reporting groups
11100800|NCT01588548|FG000|Participant Flow|AZD1208 120mg|Once daily continuous dosing schedule.
11100801|NCT01588548|FG001|Participant Flow|AZD1208 240mg|Once daily continuous dosing schedule.
11100802|NCT01588548|FG002|Participant Flow|AZD1208 360mg|Once daily continuous dosing schedule.
11100803|NCT01588548|FG003|Participant Flow|AZD1208 540mg|Once daily continuous dosing schedule.
11100804|NCT01588548|FG004|Participant Flow|AZD1208 700mg|Once daily continuous dosing schedule.
11100805|NCT01588548|FG005|Participant Flow|AZD1208 800mg|Once daily continuous dosing schedule.
11100806|NCT01588548|OG000|Outcome|AZD1208 120mg|Once daily continuous dosing schedule.
11100807|NCT01588548|OG001|Outcome|AZD1208 240mg|Once daily continuous dosing schedule.
11100808|NCT01588548|OG002|Outcome|AZD1208 360mg|Once daily continuous dosing schedule.
11100809|NCT01588548|OG003|Outcome|AZD1208 540mg|Once daily continuous dosing schedule.
11100810|NCT01588548|OG004|Outcome|AZD1208 700mg|Once daily continuous dosing schedule.
11100811|NCT01588548|OG005|Outcome|AZD1208 800mg|Once daily continuous dosing schedule.
11100812|NCT01588548|EG000|Reported Event|AZD1208 120mg|Once daily continuous dosing schedule.
11100813|NCT01588548|EG001|Reported Event|AZD1208 240mg|Once daily continuous dosing schedule.
11100814|NCT01588548|EG002|Reported Event|AZD1208 360mg|Once daily continuous dosing schedule.
11100815|NCT01588548|EG003|Reported Event|AZD1208 540mg|Once daily continuous dosing schedule.
11100816|NCT01588548|EG004|Reported Event|AZD1208 700mg|Once daily continuous dosing schedule.
11100817|NCT01588548|EG005|Reported Event|AZD1208 800mg|Once daily continuous dosing schedule.
11100818|NCT01588561|BG000|Baseline|All Study Participants|All study participants. All participants were randomized to receive all interventions, so all participants are combined into one Arm/Group.
11100819|NCT01588561|FG000|Participant Flow|Placebo First, Then Nicotine|Placebo first, then Intravenous Nicotine (1.5 mg/70 kg)
11100820|NCT01588561|FG001|Participant Flow|Nicotine First, Then Placebo|Intravenous Nicotine (1.5 mg/70 kg) first, then Placebo
11100821|NCT01588561|OG000|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
11100822|NCT01588561|OG001|Outcome|Placebo|Saline infusion
11100823|NCT01588561|EG000|Reported Event|Nicotine|Nicotine infusion
11100824|NCT01588561|EG001|Reported Event|Saline|Saline infusion
11100825|NCT01588821|BG000|Baseline|Cabozantinib|Cabozantinib: 60 mg daily by mouth
11100826|NCT01588821|FG000|Participant Flow|Cabozantinib|Cabozantinib: 60 mg daily by mouth
11100827|NCT01588821|OG000|Outcome|Cabozantinib|Cabozantinib: 60 mg daily by mouth
11100828|NCT01588821|OG000|Outcome|Treatment Arm|"Cabozantinib~Cabozantinib: 60 mg daily by mouth"
11100829|NCT01588821|EG000|Reported Event|Cabozantinib|Cabozantinib: 60 mg daily by mouth
11100830|NCT01588951|BG000|Baseline|No Leukemia Stem Cells - Consolidation|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
11100831|NCT01588951|BG001|Baseline|Leukemia Stem Cells - Consolidation|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
11100832|NCT01588951|BG002|Baseline|Leukemia Stem Cells - Transplant|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
11100833|NCT01588951|BG003|Baseline|Total|Total of all reporting groups
11100834|NCT01588951|FG000|Participant Flow|No Leukemia Stem Cells - Consolidation|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
11100835|NCT01588951|FG001|Participant Flow|Leukemia Stem Cells - Consolidation|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
11100836|NCT01588951|FG002|Participant Flow|Leukemia Stem Cells - Transplant|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
11100837|NCT01588951|OG000|Outcome|No Leukemia Stem Cells - Consolidation|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
11100838|NCT01588951|OG001|Outcome|Leukemia Stem Cells - Consolidation|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
11100839|NCT01588951|OG002|Outcome|Leukemia Stem Cells - Transplant|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
11100840|NCT01588951|EG000|Reported Event|No Leukemia Stem Cells - Consolidation|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
11100841|NCT01588951|EG001|Reported Event|Leukemia Stem Cells - Consolidation|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
11100842|NCT01588951|EG002|Reported Event|Leukemia Stem Cells - Transplant|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
11100843|NCT01588990|BG000|Baseline|Bevacizumab: Phase A and Phase B|The trial consisted of 2 phases of treatment. Phase A: Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin and 5-fluouracil [same regimen as of mFOLFOX6]) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression.
11100844|NCT01588990|FG000|Participant Flow|Bevacizumab: Phase A and Phase B|The trial consisted of 2 phases of treatment. Phase A: Participants received bevacizumab 7.5 mg/kg IV on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin and 5-fluouracil [same regimen as of mFOLFOX6]) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression.
11100845|NCT01588990|OG000|Outcome|Bevacizumab: Phase A and Phase B|The trial consisted of 2 phases of treatment. Phase A: Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin and 5-fluouracil [same regimen as of mFOLFOX6]) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression.
11100846|NCT01588990|OG000|Outcome|Bevacizumab: Phase A|In Phase A, participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) IV on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 milligrams per square meter [mg/m^2] twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity.
11100847|NCT01588990|OG000|Outcome|Bevacizumab: Phase B|Upon documented first disease progression in Phase A, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, and 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) in Phase B until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression.
11100848|NCT01588990|OG000|Outcome|Bevacizumab: Phase A and Phase B|The trial consisted of 2 phases of treatment. Phase A: Participants received bevacizumab 7.5 mg/kg IV on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin and 5-fluouracil [same regimen as of mFOLFOX6]) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression.
11100849|NCT01588990|OG000|Outcome|Bevacizumab: Phase A|In Phase A, participants received bevacizumab 7.5 mg/kg IV on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity.
11224506|NCT02360475|BG003|Baseline|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11224507|NCT02360475|BG004|Baseline|Total|Total of all reporting groups
11100850|NCT01588990|EG000|Reported Event|Bevacizumab: Phase A and Phase B|The trial consisted of 2 phases of treatment. Phase A: Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin and 5-fluouracil [same regimen as of mFOLFOX6]) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression.
11100851|NCT01589094|BG000|Baseline|Gemcitabine and Cisplatin (DD GC)|"This is a Multicenter Phase II study of dose-dense (DD) gemcitabine and cisplatin (GC) neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are candidates for radical cystectomy.~Gemcitabine and Cisplatin (DD GC): Patients will receive six cycles of GC administered every 14 days.~Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)"
11100852|NCT01589094|FG000|Participant Flow|Gemcitabine and Cisplatin (DD GC)|"This is a Multicenter Phase II study of dose-dense (DD) gemcitabine and cisplatin (GC) neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are candidates for radical cystectomy.~Gemcitabine and Cisplatin (DD GC): Patients will receive six cycles of GC administered every 14 days.~Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)"
11100853|NCT01589094|OG000|Outcome|Gemcitabine and Cisplatin (DD GC)|"This is a Multicenter Phase II study of dose-dense (DD) gemcitabine and cisplatin (GC) neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are candidates for radical cystectomy.~Gemcitabine and Cisplatin (DD GC): Patients will receive six cycles of GC administered every 14 days.~Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)"
11100854|NCT01589094|EG000|Reported Event|Gemcitabine and Cisplatin (DD GC)|"This is a Multicenter Phase II study of dose-dense (DD) gemcitabine and cisplatin (GC) neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are candidates for radical cystectomy.~Gemcitabine and Cisplatin (DD GC): Patients will receive six cycles of GC administered every 14 days.~Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)"
11100855|NCT01589185|BG000|Baseline|KBSA301, a Monoclonal Antibody Dose 1|"1 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100856|NCT01589185|BG001|Baseline|KBSA301, a Monoclonal Antibody Dose 2|"3 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100857|NCT01589185|BG002|Baseline|KBSA301, a Monoclonal Antibody Dose 3|"10 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100858|NCT01589185|BG003|Baseline|KBSA301, a Monoclonal Antibody Dose 4|"20 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100859|NCT01589185|BG004|Baseline|Placebo|"KBSA301-placebo~Placebo: Placebo administered as a single intravenous infusion"
11100860|NCT01589185|BG005|Baseline|Total|Total of all reporting groups
11100861|NCT01589185|FG000|Participant Flow|KBSA301, a Monoclonal Antibody Dose 1|"1 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100862|NCT01589185|FG001|Participant Flow|KBSA301, a Monoclonal Antibody Dose 2|"3 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100863|NCT01589185|FG002|Participant Flow|KBSA301, a Monoclonal Antibody Dose 3|"10 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100864|NCT01589185|FG003|Participant Flow|KBSA301, a Monoclonal Antibody Dose 4|"20 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100865|NCT01589185|FG004|Participant Flow|Placebo|"KBSA301-placebo~Placebo: Placebo administered as a single intravenous infusion"
11100866|NCT01589185|OG000|Outcome|KBSA301, a Monoclonal Antibody Dose 1|"1 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100867|NCT01589185|OG001|Outcome|KBSA301, a Monoclonal Antibody Dose 2|"3 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100868|NCT01589185|OG002|Outcome|KBSA301, a Monoclonal Antibody Dose 3|"10 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100869|NCT01589185|OG003|Outcome|KBSA301, a Monoclonal Antibody Dose 4|"20 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100870|NCT01589185|OG004|Outcome|Placebo|"KBSA301-placebo~Placebo: Placebo administered as a single intravenous infusion"
11100871|NCT01589185|OG005|Outcome|All Treatment Group|Sum of all four KBSA301 treatment groups (1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg)
11100872|NCT01589185|EG000|Reported Event|KBSA301, a Monoclonal Antibody Dose 1|"1 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100873|NCT01589185|EG001|Reported Event|KBSA301, a Monoclonal Antibody Dose 2|"3 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100874|NCT01589185|EG002|Reported Event|KBSA301, a Monoclonal Antibody Dose 3|"10 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100875|NCT01589185|EG003|Reported Event|KBSA301, a Monoclonal Antibody Dose 4|"20 mg/kg KBSA301~KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4."
11100876|NCT01589185|EG004|Reported Event|Placebo|"KBSA301-placebo~Placebo: Placebo administered as a single intravenous infusion"
11100877|NCT01589237|BG000|Baseline|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile."
11100878|NCT01589237|BG001|Baseline|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile."
11100879|NCT01589237|BG002|Baseline|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile."
11100880|NCT01589237|BG003|Baseline|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile."
11100881|NCT01589237|BG004|Baseline|Total|Total of all reporting groups
11100882|NCT01589237|FG000|Participant Flow|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile."
11100883|NCT01589237|FG001|Participant Flow|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile."
11100884|NCT01589237|FG002|Participant Flow|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile."
11100885|NCT01589237|FG003|Participant Flow|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile."
11100886|NCT01589237|OG000|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
11100887|NCT01589237|OG001|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
11100888|NCT01589237|OG002|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
11100889|NCT01589237|OG003|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
11003808|NCT01074047|BG001|Baseline|Conventional Care Regimens (CCR)|#1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. Consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed. # 2 Low-dose cytarabine 20 mg SC twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only includes transfusion of blood products, antibiotics, antifungals and nutritional help.
11003809|NCT01074047|BG002|Baseline|Total|Total of all reporting groups
11003810|NCT01074047|FG000|Participant Flow|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
11003811|NCT01074047|FG001|Participant Flow|Conventional Care Regimens (CCR)|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m² QD or Idarubicin 9-12 mg/m² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
11003812|NCT01074047|OG000|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
11003813|NCT01074047|OG001|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
11003814|NCT01074047|OG001|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
11003815|NCT01074047|OG001|Outcome|Conventional Care Regimen #3 Best Supportive Care Only|Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.
11003816|NCT01074047|OG002|Outcome|Conventional Care Regimen #2 Low-dose Cytarabine|Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.
11003817|NCT01074047|OG003|Outcome|Conventional Care Regimen #1 Intensive Chemotherapy|Induction Therapy included Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1). Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m^² daily or Idarubicin 9-12 mg/m^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10^9/L and platelets to at least 75 x 10^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion.
11003818|NCT01074047|EG000|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion
11003819|NCT01074047|EG001|Reported Event|BSC Only|Transfusion of blood products, antibiotics, antifungals and nutritional help
11003820|NCT01074047|EG002|Reported Event|Low-dose Cytarabine|Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC
11100890|NCT01589237|EG000|Reported Event|Part A-placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
11003821|NCT01074047|EG003|Reported Event|Intensive Chemotherapy|Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed
11003822|NCT01074047|EG004|Reported Event|Azacitidine-extension|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
11003823|NCT01074099|BG000|Baseline|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
11003824|NCT01074099|BG001|Baseline|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
11003825|NCT01074099|BG002|Baseline|Total|Total of all reporting groups
11003826|NCT01074099|FG000|Participant Flow|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
11003827|NCT01074099|FG001|Participant Flow|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
11003828|NCT01074099|OG000|Outcome|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
11003829|NCT01074099|OG001|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
11003830|NCT01074099|EG000|Reported Event|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
11003831|NCT01074099|EG001|Reported Event|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
11003832|NCT01074125|BG000|Baseline|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003833|NCT01074125|BG001|Baseline|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003834|NCT01074125|BG002|Baseline|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003835|NCT01074125|BG003|Baseline|Total|Total of all reporting groups
11003836|NCT01074125|FG000|Participant Flow|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003837|NCT01074125|FG001|Participant Flow|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003838|NCT01074125|FG002|Participant Flow|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003839|NCT01074125|OG000|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
11003840|NCT01074125|OG001|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
11003841|NCT01074125|OG002|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
11003842|NCT01074125|OG000|Outcome|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003843|NCT01074125|OG001|Outcome|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003844|NCT01074125|OG002|Outcome|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
11003845|NCT01074125|EG000|Reported Event|1g/Day|Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks
11003846|NCT01074125|EG001|Reported Event|6g/Day|Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks
11003847|NCT01074125|EG002|Reported Event|8g/Day|Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks
11003848|NCT01074164|BG000|Baseline|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
11003849|NCT01074164|BG001|Baseline|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
11003850|NCT01074164|BG002|Baseline|Total|Total of all reporting groups
11003851|NCT01074164|FG000|Participant Flow|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
11003852|NCT01074164|FG001|Participant Flow|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
11003853|NCT01074164|OG000|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
11003854|NCT01074164|OG001|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
11003855|NCT01074164|EG000|Reported Event|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
11100891|NCT01589237|EG001|Reported Event|Part A-20mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
11100892|NCT01589237|EG002|Reported Event|Part A-40mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
11100893|NCT01589237|EG003|Reported Event|Part A: Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
11100894|NCT01589237|EG004|Reported Event|Part B-placebo of Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile.
11100895|NCT01589237|EG005|Reported Event|Part B-20mg Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile.
11100896|NCT01589237|EG006|Reported Event|Part B- Pradigastat (LCQ908) Regimen- From Study A2212|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile.
11100897|NCT01589237|EG007|Reported Event|Part B-40 mg Pradigastat (LCQ908)|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile.
11100898|NCT01589263|BG000|Baseline|ARM 1: onaBoNT-A + Placebo|"onaBoNT-A 200 U prostate injection and placebo oral capsule daily~onaBoNT-A + placebo: 200 U prostate injection once~Arms: ARM 1: onaBoNT-A + placebo~Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin"
11100899|NCT01589263|BG001|Baseline|ARM 2: Saline + Tamsulosin|"Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily.~onaBoNT-A + placebo: 200 U prostate injection once~Arms: ARM 1: onaBoNT-A + placebo~Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin"
11100900|NCT01589263|BG002|Baseline|Total|Total of all reporting groups
11100901|NCT01589263|FG000|Participant Flow|ARM 1: onaBoNT-A + Placebo|"onaBoNT-A 200 U prostate injection and placebo oral capsule daily~onaBoNT-A + placebo: 200 U prostate injection once~Arms: ARM 1: onaBoNT-A + placebo~Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin"
11100902|NCT01589263|FG001|Participant Flow|ARM 2: Saline + Tamsulosin|"Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily.~onaBoNT-A + placebo: 200 U prostate injection once~Arms: ARM 1: onaBoNT-A + placebo~Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin"
11100903|NCT01589263|OG000|Outcome|ARM 1: onaBoNT-A + Placebo|"onaBoNT-A 200 U prostate injection and placebo oral capsule daily~onaBoNT-A + placebo: 200 U prostate injection once~Arms: ARM 1: onaBoNT-A + placebo~Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin"
11100904|NCT01589263|OG001|Outcome|ARM 2: Saline + Tamsulosin|"Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily.~onaBoNT-A + placebo: 200 U prostate injection once~Arms: ARM 1: onaBoNT-A + placebo~Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin"
11100905|NCT01589263|EG000|Reported Event|ARM 1: onaBoNT-A + Placebo|"onaBoNT-A 200 U prostate injection and placebo oral capsule daily~onaBoNT-A + placebo: 200 U prostate injection once~Arms: ARM 1: onaBoNT-A + placebo~Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin"
11100906|NCT01589263|EG001|Reported Event|ARM 2: Saline + Tamsulosin|"Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily.~onaBoNT-A + placebo: 200 U prostate injection once~Arms: ARM 1: onaBoNT-A + placebo~Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin"
11100907|NCT01589302|BG000|Baseline|Treatment (Ibrutinib)|Patients were treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. Patients received ibrutinib orally (PO) once daily(QD)on days 1-28. Courses repeat every 28 days in the absence of disease progression
11100908|NCT01589302|FG000|Participant Flow|Treatment (Ibrutinib)|Patients were treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. Patients received ibrutinib orally (PO) once daily(QD)on days 1-28. Courses repeat every 28 days in the absence of disease progression
11126409|NCT01733186|EG000|Reported Event|Dose A Cohort|"Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect~Cartilage defect size range: 2 to 5 cm2 (Dose A)~CARTISTEM®"
11126410|NCT01733186|EG001|Reported Event|Dose B Cohort|"Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect~Cartilage defect size range: above 5 cm2 (Dose B)~CARTISTEM®"
11100909|NCT01589302|OG000|Outcome|Treatment (Ibrutinib)|"Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.~ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression"
11100910|NCT01589302|OG000|Outcome|Treatment (Ibrutinib)|"Patients will be treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.~ibrutinib: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease pro"
11100911|NCT01589302|EG000|Reported Event|Treatment (Ibrutinib)|"Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.~ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progres"
11100912|NCT01589315|BG000|Baseline|FEAST|"Active right unilateral focal ECT~focal ECT: FEAST, ECT, unidirectional stimulation"
11100913|NCT01589315|FG000|Participant Flow|FEAST|"Active right unilateral focal ECT~focal ECT: FEAST, ECT, unidirectional stimulation"
11100914|NCT01589315|OG000|Outcome|FEAST|"Active right unilateral focal ECT~focal ECT: FEAST, ECT, unidirectional stimulation"
11100915|NCT01589315|EG000|Reported Event|FEAST|"Active right unilateral focal ECT~focal ECT: FEAST, ECT, unidirectional stimulation"
11100916|NCT01589445|BG000|Baseline|Single Group Study With Two Interventions|"This was double blind, single group and within subjects designed study with two interventions.We screened 130 patients, selected 77 subjects who received drug Code 001, then gone through one month wash out period, then received Code 002.For PPARγ genotyping blood samples were collected from patients. There were found two groups-Pro12Pro and Pro12Ala. Baseline evaluation included detailed medical history,socioeconomic status, physical examination, and laboratory investigations for biomedical variables,psychosocial factors according to Patient Health Questionnaire (PHQ-9) and WHO-5 questionnaires.We decoded blinded drug after analyzing the results and knew that pioglitazone (30 mg once daily) was coded as 001 and metformin (850 mg once daily) as code 002.~For statistical analysis we compare Pio vs Met, Pro12Pro vs Pro12Ala, met responder vs non responder."
11100917|NCT01589445|FG000|Participant Flow|Single Group Study With Two Drugs- Pioglitazone and Metformin|"Group 001-Pioglitazone 30 mg tablet once daily Group 002-Metformin 850 mg tablet once daily~The single group study with a wash out period of one month with metformin 850 mg tablet once daily.~77 patients started with pioglitazone(7 drop out)and after one month wash out period 70 patients started with metformin (9 drop out).~48 patients for the 1st 3 months of pioglitazone and 32 patients for the 2nd 3 months of metformin responded to the drugs respectively according to the response rate[The treatment target was set to reduce at least ≥10% FBG or ≥1% HbA1c in the patients considering as the responder group]."
11100918|NCT01589445|OG000|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
11100919|NCT01589445|OG001|Outcome|Metformin (002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
11100920|NCT01589445|OG000|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30mg once daily for 3 months.
11100921|NCT01589445|OG001|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
11100922|NCT01589445|EG000|Reported Event|Pioglitazone (001 Group)|"77 patients received the drug pioglitazone (30mg/day) for 3 months. Adverse events were assessed non-systematically on patients' complain generally and also systematically in case of hypertension, weight gain, common depression [Patient Health Questionnaire (PHQ-9) method] and creatinine increase.~No serious adverse event was found during pioglitazone trial.~In case of other adverse event, one patient complained for peripheral edema which disappeared (without medicine) within 2 days at the 2nd month of the treatment, Four patients gained weight within 10% of their initial weight after 3 months of the treatment and two patients complained for abdominal discomfort in the 1st month and normal treatment with antacid was provided to them."
11126411|NCT01733212|BG000|Baseline|Ginger|2 gm powder of ginger filled in a capsule
11126412|NCT01733212|BG001|Baseline|Placebo|2 gm of placebo pill (A capsule)
10845997|NCT00272168|BG000|Baseline|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
11126413|NCT01733212|BG002|Baseline|Total|Total of all reporting groups
11126414|NCT01733212|FG000|Participant Flow|Ginger|2 gm powder of ginger filled in a capsule
11126415|NCT01733212|FG001|Participant Flow|Placebo|2 gm of placebo pill (A capsule)
11126416|NCT01733212|OG000|Outcome|Ginger|2 gm powder of ginger filled in a capsule
11100923|NCT01589445|EG001|Reported Event|Metformin (002 Group)|"After wash out period 70 patients started with metformin (850mg/day) for further 3 months. Adverse events were assessed non-systematically on patients' complain and also systematically in case of hypertension, weight gain, common depression (PHQ-9 method) and creatinine increase.~On basis of systemic data review and patient complain one patient was found with hypertension and another one was with increased creatinine level at the end of the metformin treatment and these events were assumed as serious adverse events as they were at health risk and withdrawn from the trial for intervention by hospital physician though they didn't need for hospitalization.~One patient complained for mild diarrhea in the first month of the metformin treatment, the patient needed necessary treatment according to doctor's advice for one day, Five patients complained for abdominal discomfort in the 1st month and antacid was provided. Six patients were assumed suffering from common depression."
11100924|NCT01589484|BG000|Baseline|Shockwave Lithotripsy (SWL)|One hundred patients fulfilled the inclusion and exclusion criteria and were enrolled in this study. Mean age and BMI were 47.1 years and 28.0 Kg/m2, respectively. Half of patients had their stone localized in the right kidney. Mean stone size was 9.1mm and mean stone density was 795 HU.
11100925|NCT01589484|FG000|Participant Flow|Shockwave Lithotripsy (SWL)|All patients were submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients were submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
11100926|NCT01589484|OG000|Outcome|Primary Endoint|Shock wave lithotripsy outcome
11100927|NCT01589484|OG000|Outcome|SWL Complications|Shock wave lithotripsy complications
11100928|NCT01589484|EG000|Reported Event|Shockwave Lithotripsy (SWL)|All patients will be submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
11100929|NCT01589497|BG000|Baseline|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
11100930|NCT01589497|BG001|Baseline|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
11100931|NCT01589497|BG002|Baseline|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
11100932|NCT01589497|BG003|Baseline|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
11100933|NCT01589497|BG004|Baseline|Total|Total of all reporting groups
11100934|NCT01589497|FG000|Participant Flow|RHZE-RHZE|"Participants were administered RHZE from Day 1 to Day 14. Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily."
11100935|NCT01589497|FG001|Participant Flow|RHZE-RZE|"Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.~Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once"
11100936|NCT01589497|FG002|Participant Flow|RHZE-RMZE|"Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.~Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.~Moxifloxacin: one 400 mg tablet orally once a day."
11100937|NCT01589497|FG003|Participant Flow|RZE-RZE|"Participants were administered only RZE from Day 1 through Day 14. Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily."
11100938|NCT01589497|OG000|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
11100939|NCT01589497|OG001|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
11100940|NCT01589497|OG002|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
11100941|NCT01589497|OG003|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
11100942|NCT01589497|OG002|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
11126417|NCT01733212|OG001|Outcome|Placebo|2 gm of placebo pill (A capsule)
11100943|NCT01589497|OG000|Outcome|Standard Processing Method|The standard sputum processing method
11100944|NCT01589497|OG001|Outcome|Decontaminated Processing Method|The decontaminated sputum processing method
11100945|NCT01589497|OG000|Outcome|Overall|Qualified samples from overall participants
11100946|NCT01589497|OG000|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
11100947|NCT01589497|EG000|Reported Event|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
11100948|NCT01589497|EG001|Reported Event|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
11100949|NCT01589497|EG002|Reported Event|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
11100950|NCT01589497|EG003|Reported Event|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
11100951|NCT01589510|BG000|Baseline|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
11100952|NCT01589510|FG000|Participant Flow|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
11100953|NCT01589510|OG000|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
11100954|NCT01589510|EG000|Reported Event|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
11100955|NCT01589601|BG000|Baseline|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
11100956|NCT01589601|BG001|Baseline|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
11100957|NCT01589601|BG002|Baseline|Total|Total of all reporting groups
11100958|NCT01589601|FG000|Participant Flow|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
11100959|NCT01589601|FG001|Participant Flow|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
11100960|NCT01589601|OG000|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
10846703|NCT00279201|OG003|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
11100961|NCT01589601|OG001|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
11126418|NCT01733212|EG000|Reported Event|Ginger|2 gm powder of ginger filled in a capsule
11126419|NCT01733212|EG001|Reported Event|Placebo|2 gm of placebo capsule
11126420|NCT01733238|BG000|Baseline|PNT2258|PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
11126421|NCT01733238|FG000|Participant Flow|PNT2258|PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
11100962|NCT01589601|EG000|Reported Event|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
11100963|NCT01589601|EG001|Reported Event|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
11126422|NCT01733238|OG000|Outcome|PNT2258|PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
11126423|NCT01733238|EG000|Reported Event|PNT2258|PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
11126424|NCT01733277|BG000|Baseline|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
11126425|NCT01733277|BG001|Baseline|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
11126426|NCT01733277|BG002|Baseline|Total|Total of all reporting groups
11126427|NCT01733277|FG000|Participant Flow|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
11126428|NCT01733277|FG001|Participant Flow|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
11126429|NCT01733277|OG000|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
11126430|NCT01733277|OG001|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
11126431|NCT01733277|EG000|Reported Event|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
11126432|NCT01733277|EG001|Reported Event|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
11126433|NCT01733316|BG000|Baseline|All Participants|"Cystagon® Phase: From Screening and during Months 1, 2, 3 participants received their usual dose of Cystagon® Q6H.~RP103 Phase: During Months 3.5, 4, 5, 6, 7 participants received RP103 Q12H.~Long Term Phase: On or after Month 7, for the remainder of study participants received RP103 Q12H."
11126434|NCT01733316|FG000|Participant Flow|All Participants|"Cystagon® Phase: From Screening and during Months 1, 2, 3 participants received their usual dose of Cystagon® every 6 hours (Q6H).~RP103 Phase: During Months 3.5, 4, 5, 6, 7 participants received RP103 every 12 hours (Q12H).~Long Term Phase: On or after Month 7, for the remainder of study participants received RP103 Q12H."
11126435|NCT01733316|OG000|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
11126436|NCT01733316|OG001|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
11126437|NCT01733316|OG000|Outcome|Cystagon® Phase|"From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.~Observations from Day 1 Cystagon® dosing up to the first dose of RP103 were attributed to the Cystagon® Phase."
11126438|NCT01733316|OG001|Outcome|RP103 Phase|"During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.~Observations on or after the first dose of RP103 up to Month 7 or study termination visit (whichever occurred first) were attributed to the RP103 Phase."
11126439|NCT01733316|OG002|Outcome|Long-Term Phase|"From Month 7 and for the remainder of study: participants received RP103 Q12H.~Observations on or after the Month 7 visit through study termination were attributed to the Long-Term RP103 Phase."
11126440|NCT01733316|OG000|Outcome|Halitosis Substudy Participants|"Cystagon® Phase: From Screening and during Months 1, 2, 3 participants received their usual dose of Cystagon® Q6H.~RP103 Phase: During Months 3.5, 4, 5, 6, 7 participants received RP103 Q12H."
11126441|NCT01733316|EG000|Reported Event|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
10846704|NCT00279201|EG000|Reported Event|Insulin Glargine Initiation|
10846705|NCT00279201|EG001|Reported Event|Lispro LM Initiation|
10846706|NCT00279201|EG002|Reported Event|Lispro Mid Mix Prior Lispro LM Addendum|
11126442|NCT01733316|EG001|Reported Event|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
11126443|NCT01733316|EG002|Reported Event|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
11126444|NCT01733329|BG000|Baseline|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
11126445|NCT01733329|BG001|Baseline|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist . The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
11126446|NCT01733329|BG002|Baseline|Total|Total of all reporting groups
11126447|NCT01733329|FG000|Participant Flow|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=62) or placebo (n=61) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
11100964|NCT01589653|BG000|Baseline|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
11100965|NCT01589653|BG001|Baseline|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
11100966|NCT01589653|BG002|Baseline|Total|Total of all reporting groups
11100967|NCT01589653|FG000|Participant Flow|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
11100968|NCT01589653|FG001|Participant Flow|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
11100969|NCT01589653|OG000|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
11100970|NCT01589653|OG001|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
11100971|NCT01589653|EG000|Reported Event|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
11100972|NCT01589653|EG001|Reported Event|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
11100973|NCT01589770|BG000|Baseline|Rheumatoid Arthritis Patients|People who have rheumatoid arthritis
11100974|NCT01589770|BG001|Baseline|Controls|people who do not have RA or other inflammatory disease
11100975|NCT01589770|BG002|Baseline|Total|Total of all reporting groups
11100976|NCT01589770|FG000|Participant Flow|Rheumatoid Arthritis Patients|People who have rheumatoid arthritis
11100977|NCT01589770|FG001|Participant Flow|Controls|people who do not have RA or other inflammatory disease
11100978|NCT01589770|OG000|Outcome|Rheumatoid Arthritis Patients|People who have rheumatoid arthritis
11100979|NCT01589770|OG001|Outcome|Controls|people who do not have RA or other inflammatory disease
11100980|NCT01589770|EG000|Reported Event|Rheumatoid Arthritis Patients|People who have rheumatoid arthritis
11100981|NCT01589770|EG001|Reported Event|Controls|people who do not have RA or other inflammatory disease
11100982|NCT01589822|BG000|Baseline|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative"
11100983|NCT01589822|BG001|Baseline|Standard of Care|Standard surgical technique for GI anastomosis.
11100984|NCT01589822|BG002|Baseline|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative"
11100985|NCT01589822|BG003|Baseline|Total|Total of all reporting groups
11100986|NCT01589822|FG000|Participant Flow|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative"
11100987|NCT01589822|FG001|Participant Flow|Standard of Care|Standard surgical technique for GI anastomosis.
11100988|NCT01589822|FG002|Participant Flow|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative"
11100989|NCT01589822|OG000|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (IIT)"
11100990|NCT01589822|OG001|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (IIT)
10846707|NCT00279201|EG003|Reported Event|Lispro LM Prior Glargine Addendum|
10846708|NCT00279201|EG004|Reported Event|Basal Bolus Prior Lispro LM Addendum|
11100991|NCT01589822|OG002|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
11100992|NCT01589822|OG000|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
11100993|NCT01589822|OG001|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
11100994|NCT01589822|EG000|Reported Event|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
11100995|NCT01589822|EG001|Reported Event|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
11100996|NCT01589822|EG002|Reported Event|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
11100997|NCT01589978|BG000|Baseline|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
11126448|NCT01733329|FG001|Participant Flow|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
11126449|NCT01733329|OG000|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
11100998|NCT01589978|FG000|Participant Flow|PROMUS Element Overall Population|"Subjects who receive the PROMUS Element everolimus-eluting coronary stent.~Subgroups within the Overall Population Group:~PLATINUM-Like Patients N=776 (at time of Primary endpoint)~Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and <2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm.~Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent."
11100999|NCT01589978|OG000|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
11101000|NCT01589978|OG000|Outcome|PROMUS Element Overall Population|Subjects who receive the PROMUS Element everolimus-eluting coronary stent.
11101001|NCT01589978|EG000|Reported Event|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
11101002|NCT01590017|BG000|Baseline|Cistplatin and Radiation Therapy|"Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).~cisplatin~external beam radiation therapy"
11101003|NCT01590017|FG000|Participant Flow|Cistplatin and Radiation Therapy|"Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).~cisplatin~external beam radiation therapy"
11101004|NCT01590017|OG000|Outcome|Cistplatin and Radiation Therapy|"Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).~cisplatin~external beam radiation therapy"
11101005|NCT01590017|EG000|Reported Event|Cistplatin and Radiation Therapy|"Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).~cisplatin~external beam radiation therapy"
11101006|NCT01590082|BG000|Baseline|Phase I: Doxycycline + Ipilimumab + Temozolomide|Oral Doxycycline starting dose 200 mg twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts), thereafter with Ipilimumab 3 mg by vein (IV) on Day 1 of each 21 day cycle for 4 cycles, oral Temozolomide 200 mg/m2 on Days 1 - 4 of each 21 day cycle for 4 cycles.
11101007|NCT01590082|BG001|Baseline|Phase II|Oral Doxycycline 200 mg twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts), thereafter with Ipilimumab 3 mg by vein (IV) on Day 1 of each 21 day cycle for 4 cycles, oral Temozolomide 200 mg/m2 on Days 1 - 4 of each 21 day cycle for 4 cycles.
11101008|NCT01590082|BG002|Baseline|Total|Total of all reporting groups
11101009|NCT01590082|FG000|Participant Flow|Phase I: Doxycycline + Ipilimumab + Temozolomide|Oral Doxycycline starting dose 200 mg twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts), thereafter with Ipilimumab 3 mg by vein (IV) on Day 1 of each 21 day cycle for 4 cycles, oral Temozolomide 200 mg/m2 on Days 1 - 4 of each 21 day cycle for 4 cycles.
11101010|NCT01590082|FG001|Participant Flow|Phase II|Oral Doxycycline 200 mg twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts), thereafter with Ipilimumab 3 mg by vein (IV) on Day 1 of each 21 day cycle for 4 cycles, oral Temozolomide 200 mg/m2 on Days 1 - 4 of each 21 day cycle for 4 cycles.
11101011|NCT01590082|OG000|Outcome|Phase I: Doxycycline, Ipilimumab, and Temozolomide|Oral Doxycycline starting dose 200 mg twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts), thereafter with Ipilimumab 3 mg by vein (IV) on Day 1 of each 21 day cycle for 4 cycles, oral Temozolomide 200 mg/m2 on Days 1 - 4 of each 21 day cycle for 4 cycles.
11101012|NCT01590082|OG001|Outcome|Phase II|Oral Doxycycline 200 mg twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts), thereafter with Ipilimumab 3 mg by vein (IV) on Day 1 of each 21 day cycle for 4 cycles, oral Temozolomide 200 mg/m2 on Days 1 - 4 of each 21 day cycle for 4 cycles.
11101013|NCT01590082|EG000|Reported Event|Phase I: Doxycycline + Ipilimumab + Temozolomide|Oral Doxycycline starting dose 200 mg twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts), thereafter with Ipilimumab 3 mg by vein (IV) on Day 1 of each 21 day cycle for 4 cycles, oral Temozolomide 200 mg/m2 on Days 1 - 4 of each 21 day cycle for 4 cycles.
11101014|NCT01590082|EG001|Reported Event|Phase II|Oral Doxycycline 200 mg twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts), thereafter with Ipilimumab 3 mg by vein (IV) on Day 1 of each 21 day cycle for 4 cycles, oral Temozolomide 200 mg/m2 on Days 1 - 4 of each 21 day cycle for 4 cycles.
11101015|NCT01590212|BG000|Baseline|Mellow Bumps (MB) + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
11101016|NCT01590212|BG001|Baseline|Chill-out in Pregnancy (CHiP) + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
11101017|NCT01590212|BG002|Baseline|Care as Usual (CAU)|Participants received care in line with local guidelines.
11101018|NCT01590212|BG003|Baseline|Total|Total of all reporting groups
11101019|NCT01590212|FG000|Participant Flow|Mellow Bumps + Care as Usual|"Mellow Bumps is a targeted intervention aimed at pregnant women with additional health and social care needs.~Underpinned by attachment theory, there is a focus on:~Improving maternal wellbeing by reducing stress and anxiety Increasing expectant mother's understandings of neonates' capacity for social interaction Emphasising the importance of early interaction to enhance brain development and attachment.~Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
11101020|NCT01590212|FG001|Participant Flow|Chill-out in Pregnancy + Care as Usual|"Chill-out in Pregnancy is a targeted intervention aimed at pregnant women with additional health and social care needs.~It is a stress-reduction programme which includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship elements.~Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
11101021|NCT01590212|FG002|Participant Flow|Care as Usual|"Care-as-usual comprises routine antenatal care provided by the NHS in line with local guidelines.~Services provided as part of an individividual woman's care plan. If indicated, a pre-birth case conference is held at 28-32 weeks."
11101022|NCT01590212|OG000|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
11101023|NCT01590212|OG001|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
11101024|NCT01590212|OG002|Outcome|Care as Usual|All participants received care in line with local guidelines.
11101025|NCT01590212|OG002|Outcome|Care as Usual|Participants received care in line with local guidelines
11101026|NCT01590212|EG000|Reported Event|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
11101027|NCT01590212|EG001|Reported Event|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
11101028|NCT01590212|EG002|Reported Event|Care as Usual|Participants received care in line with local guidelines
11101029|NCT01590238|BG000|Baseline|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
11101030|NCT01590238|FG000|Participant Flow|Treatment With PRFM|"Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
11101031|NCT01590238|OG000|Outcome|Treatment With PRFM|Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured (6 months after initial treatment) and compared to hair density index measured prior to treatment for each subject.
11101032|NCT01590238|EG000|Reported Event|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
11101033|NCT01590264|BG000|Baseline|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
10846709|NCT00279201|EG005|Reported Event|Basal Bolus Prior Glargine Addendum|
10846710|NCT00279201|EG006|Reported Event|Insulin Glargine Maintenance|
11101034|NCT01590264|FG000|Participant Flow|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
11101035|NCT01590264|OG000|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
11101036|NCT01590264|EG000|Reported Event|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
11101037|NCT01590433|BG000|Baseline|Exenatide|"Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.~Exenatide: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study."
11101038|NCT01590433|BG001|Baseline|Placebo|"Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.~Placebo: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.~Dietary counseling: All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment."
11101039|NCT01590433|BG002|Baseline|Total|Total of all reporting groups
11101040|NCT01590433|FG000|Participant Flow|Exenatide|"Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.~Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study."
11101041|NCT01590433|FG001|Participant Flow|Placebo|Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
11101042|NCT01590433|OG000|Outcome|Exenatide|"Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.~Exenatide: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study."
11101043|NCT01590433|OG001|Outcome|Placebo|"Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.~Placebo: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.~Dietary counseling: All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment."
11101044|NCT01590433|EG000|Reported Event|Exenatide|Exenatide: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
11101045|NCT01590433|EG001|Reported Event|Placebo|"Placebo: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.~Dietary counseling: All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment."
11101046|NCT01590550|BG000|Baseline|Observational|All patients receiving acute HD during the study period
11101047|NCT01590550|FG000|Participant Flow|Observational|All patients receiving acute HD during the study period
11101048|NCT01590550|OG000|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
11101049|NCT01590550|OG000|Outcome|Observational|All patients receiving acute HD during the study period
11101050|NCT01590550|EG000|Reported Event|Observational|All patients receiving acute HD during the study period
11101051|NCT01590563|BG000|Baseline|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
11101052|NCT01590563|FG000|Participant Flow|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
11101053|NCT01590563|OG000|Outcome|Investigated Device Group|Group inserted the investigated device - the IUB SCu300A
11101054|NCT01590563|OG000|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
11101055|NCT01590563|EG000|Reported Event|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
11101056|NCT01590758|BG000|Baseline|Topical Pexiganan Cream 0.8%|"Topical pexiganan cream 0.8%: 14 days of treatment~Standard wound care: 28-day trial period"
11101057|NCT01590758|BG001|Baseline|Topical Placebo Control|"Topical placebo cream: 14 days of treatment~Standard wound care: 28-day trial period"
11101058|NCT01590758|BG002|Baseline|Total|Total of all reporting groups
11101059|NCT01590758|FG000|Participant Flow|Topical Pexiganan Cream 0.8%|"Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
11101060|NCT01590758|FG001|Participant Flow|Topical Placebo Control|"Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
11101061|NCT01590758|OG000|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
10878604|NCT00453362|BG000|Baseline|Erlotinib|Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
11101062|NCT01590758|OG001|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
11101063|NCT01590758|EG000|Reported Event|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
11101064|NCT01590758|EG001|Reported Event|Topical Placebo Control|Topical placebo cream: 14 days of treatment
11101065|NCT01590771|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
11101066|NCT01590771|BG001|Baseline|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
11101067|NCT01590771|BG002|Baseline|Total|Total of all reporting groups
11101068|NCT01590771|FG000|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
11101069|NCT01590771|FG001|Participant Flow|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
11101070|NCT01590771|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
11101071|NCT01590771|OG001|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
11101072|NCT01590771|EG000|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
11101073|NCT01590771|EG001|Reported Event|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
11101074|NCT01590797|BG000|Baseline|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
11101075|NCT01590797|BG001|Baseline|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
11101076|NCT01590797|BG002|Baseline|Total|Total of all reporting groups
11101077|NCT01590797|FG000|Participant Flow|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
11101078|NCT01590797|FG001|Participant Flow|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
11101079|NCT01590797|OG000|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
11101080|NCT01590797|OG001|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
11101081|NCT01590797|EG000|Reported Event|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
11101082|NCT01590797|EG001|Reported Event|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
11101083|NCT01590810|BG000|Baseline|Panel A - MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
11126450|NCT01733329|OG001|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
11101084|NCT01590810|BG001|Baseline|Panel B - MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
11101085|NCT01590810|BG002|Baseline|Panel C - MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
11101086|NCT01590810|BG003|Baseline|Panel D - MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
11101087|NCT01590810|BG004|Baseline|Panel D - Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
11101088|NCT01590810|BG005|Baseline|Total|Total of all reporting groups
11101089|NCT01590810|FG000|Participant Flow|Panel A - MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
11101090|NCT01590810|FG001|Participant Flow|Panel B - MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
11101091|NCT01590810|FG002|Participant Flow|Panel C - MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
11101092|NCT01590810|FG003|Participant Flow|Panel D - MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
11101093|NCT01590810|FG004|Participant Flow|Panel D - Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
11101094|NCT01590810|OG000|Outcome|Panel A - MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
11101095|NCT01590810|OG001|Outcome|Panel B - MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
10846711|NCT00279201|EG007|Reported Event|Lispro LM Maintenance|
11101096|NCT01590810|OG002|Outcome|Panel C - MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
11101097|NCT01590810|OG003|Outcome|Panel D - MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
11101098|NCT01590810|OG004|Outcome|Panel D - Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
11101099|NCT01590810|OG000|Outcome|Panel A - MK-8150 2 mg|Single dose of MK-8150 2 mg
11101100|NCT01590810|OG001|Outcome|Panel A - MK-8150 6 mg|Single dose of MK-8150 6 mg
11101101|NCT01590810|OG002|Outcome|Panel A - MK-8150 24 mg|Single dose of MK-8150 24 mg
11101102|NCT01590810|OG003|Outcome|Panel A - MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
11101103|NCT01590810|OG004|Outcome|Panel A - MK-8150 90 mg|Single dose of MK-8150 90 mg
11101104|NCT01590810|OG005|Outcome|Panel A - Placebo|Single dose of placebo
11101105|NCT01590810|OG000|Outcome|Panel B - MK-8150 4 mg|Single dose of MK-8150 4 mg
11101106|NCT01590810|OG001|Outcome|Panel B - MK-8150 12 mg|Single dose of MK-8150 12 mg
11101107|NCT01590810|OG002|Outcome|Panel B - MK-8150 45 mg|Single dose of MK-8150 45 mg
11101108|NCT01590810|OG003|Outcome|Panel B - MK-8150 120 mg|Single dose of MK-8150 120 mg
11101109|NCT01590810|OG004|Outcome|Panel B - MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
11101110|NCT01590810|OG005|Outcome|Panel B - Placebo|Single dose of placebo
11101111|NCT01590810|OG000|Outcome|Panel C - MK-8150 5 mg|Single dose of MK-8150 5 mg
11101112|NCT01590810|OG001|Outcome|Panel C - MK-8150 24 mg|Single dose of MK-8150 24 mg
11101113|NCT01590810|OG002|Outcome|Panel C - MK-8150 90 mg|Single dose of MK-8150 90 mg
11101114|NCT01590810|OG003|Outcome|Panel C - Placebo|Single dose of placebo
11101115|NCT01590810|OG000|Outcome|Panel D - MK-8150 50 mg|Single dose of MK-8150 50 mg
11101116|NCT01590810|OG001|Outcome|Panel D - MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
11101117|NCT01590810|OG002|Outcome|Panel D - MK-8150 100 mg|Single dose of MK-8150 100 mg
11101118|NCT01590810|OG003|Outcome|Panel D - MK-8150 200 mg|Single dose of MK-8150 200 mg
11101119|NCT01590810|OG004|Outcome|Panel D - Placebo|Single dose of placebo
11101120|NCT01590810|EG000|Reported Event|Panel A - MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
11101121|NCT01590810|EG001|Reported Event|Panel B - MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
11101122|NCT01590810|EG002|Reported Event|Panel C - MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
11101123|NCT01590810|EG003|Reported Event|Panel D - MK-8150 50 to 200 mg|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
10846712|NCT00279214|BG000|Baseline|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
11101124|NCT01590810|EG004|Reported Event|Panel D - Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
11101125|NCT01590875|BG000|Baseline|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
11101126|NCT01590875|BG001|Baseline|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
11101127|NCT01590875|BG002|Baseline|Total|Total of all reporting groups
11101128|NCT01590875|FG000|Participant Flow|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
11101129|NCT01590875|FG001|Participant Flow|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
11101130|NCT01590875|OG000|Outcome|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
11101131|NCT01590875|OG001|Outcome|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
11101132|NCT01590875|OG000|Outcome|Adenosine Arm|"10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given only if no reconnection after initial dose.~Of these 10 patients, 3 patients were noted to have pulmonary vein reconnection post initial dose of adenosine in at least one pulmonary vein. No patient demonstrated pulmonary vein reconnection with second dose of adenosine."
11101133|NCT01590875|OG001|Outcome|Observation Arm|"10 patients were randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.~Of these 10 patients, none demonstrated pulmonary vein reconnection during the 10 minute period of observation."
11101134|NCT01590875|EG000|Reported Event|Adenosine Arm|10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients without reconnection after initial dose.
11101135|NCT01590875|EG001|Reported Event|Observation Arm|10 patients were be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
11101136|NCT01590888|BG000|Baseline|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
11101137|NCT01590888|BG001|Baseline|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
11101138|NCT01590888|BG002|Baseline|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
11101139|NCT01590888|BG003|Baseline|Total|Total of all reporting groups
11101140|NCT01590888|FG000|Participant Flow|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
11101141|NCT01590888|FG001|Participant Flow|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
11101142|NCT01590888|FG002|Participant Flow|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
11101143|NCT01590888|OG000|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
11101144|NCT01590888|OG001|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
11101145|NCT01590888|OG002|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
11101146|NCT01590888|EG000|Reported Event|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
11101147|NCT01590888|EG001|Reported Event|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
11101148|NCT01590888|EG002|Reported Event|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
11101149|NCT01590979|BG000|Baseline|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
11101150|NCT01590979|BG001|Baseline|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
11101151|NCT01590979|BG002|Baseline|Total|Total of all reporting groups
11101152|NCT01590979|FG000|Participant Flow|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
11101153|NCT01590979|FG001|Participant Flow|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
11101154|NCT01590979|OG000|Outcome|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
11101155|NCT01590979|OG001|Outcome|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
11101156|NCT01590979|EG000|Reported Event|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
11101157|NCT01590979|EG001|Reported Event|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
11101158|NCT01591005|BG000|Baseline|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
11101159|NCT01591005|BG001|Baseline|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
11101160|NCT01591005|BG002|Baseline|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
11101161|NCT01591005|BG003|Baseline|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
11101162|NCT01591005|BG004|Baseline|Total|Total of all reporting groups
11101163|NCT01591005|FG000|Participant Flow|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
11101164|NCT01591005|FG001|Participant Flow|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
11101165|NCT01591005|FG002|Participant Flow|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
11101166|NCT01591005|FG003|Participant Flow|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
11101167|NCT01591005|OG000|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
11101168|NCT01591005|OG001|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
11101169|NCT01591005|OG002|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
11101170|NCT01591005|OG003|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
11101171|NCT01591005|EG000|Reported Event|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
11101172|NCT01591005|EG001|Reported Event|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
11101173|NCT01591005|EG002|Reported Event|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
11101174|NCT01591005|EG003|Reported Event|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
11101175|NCT01591018|BG000|Baseline|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
11101176|NCT01591018|BG001|Baseline|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
11101177|NCT01591018|BG002|Baseline|Total|Total of all reporting groups
11101178|NCT01591018|FG000|Participant Flow|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
11101179|NCT01591018|FG001|Participant Flow|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
11101180|NCT01591018|OG000|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
11101181|NCT01591018|OG001|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
11101182|NCT01591018|EG000|Reported Event|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
11101183|NCT01591018|EG001|Reported Event|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
11101184|NCT01591044|BG000|Baseline|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
11101185|NCT01591044|BG001|Baseline|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
11101186|NCT01591044|BG002|Baseline|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
11101187|NCT01591044|BG003|Baseline|Total|Total of all reporting groups
11101188|NCT01591044|FG000|Participant Flow|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
11101189|NCT01591044|FG001|Participant Flow|Placebo|Placebo: 1 puff bid or 2 puffs bid
11101190|NCT01591044|FG002|Participant Flow|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
11101191|NCT01591044|OG000|Outcome|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
11101192|NCT01591044|OG001|Outcome|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
11101193|NCT01591044|OG002|Outcome|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
11101194|NCT01591044|EG000|Reported Event|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
11101195|NCT01591044|EG001|Reported Event|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
11101196|NCT01591044|EG002|Reported Event|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
11101197|NCT01591161|BG000|Baseline|Mapracorat|"Mapracorat ophthalmic suspension, 3%,~Mapracorat: 1 drop of study medication into the study eye QID for 14 days"
11101198|NCT01591161|BG001|Baseline|Vehicle|"The vehicle of the mapracorat ophthalmic suspension~Placebo: 1 drop of vehicle into the study eye QID for 14 days."
11101199|NCT01591161|BG002|Baseline|Total|Total of all reporting groups
11101200|NCT01591161|FG000|Participant Flow|Mapracorat|"Mapracorat ophthalmic suspension, 3%,~Mapracorat: 1 drop of study medication into the study eye QID for 14 days"
11101201|NCT01591161|FG001|Participant Flow|Vehicle|"The vehicle of the mapracorat ophthalmic suspension~Placebo: 1 drop of vehicle into the study eye QID for 14 days."
11101202|NCT01591161|OG000|Outcome|Mapracorat|"Mapracorat ophthalmic suspension, 3%,~Mapracorat: 1 drop of study medication into the study eye QID for 14 days"
11101203|NCT01591161|OG001|Outcome|Vehicle|"The vehicle of the mapracorat ophthalmic suspension~Placebo: 1 drop of vehicle into the study eye QID for 14 days."
11101204|NCT01591161|EG000|Reported Event|Mapracorat|"Mapracorat ophthalmic suspension, 3%,~Mapracorat: 1 drop of study medication into the study eye QID for 14 days"
11101205|NCT01591161|EG001|Reported Event|Vehicle|"The vehicle of the mapracorat ophthalmic suspension~Placebo: 1 drop of vehicle into the study eye QID for 14 days."
11101206|NCT01591317|BG000|Baseline|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
11101207|NCT01591317|BG001|Baseline|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
11101208|NCT01591317|BG002|Baseline|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
11101209|NCT01591317|BG003|Baseline|Total|Total of all reporting groups
11101210|NCT01591317|FG000|Participant Flow|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
11101211|NCT01591317|FG001|Participant Flow|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
11101212|NCT01591317|FG002|Participant Flow|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
11101213|NCT01591317|OG000|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
11101214|NCT01591317|OG001|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
11101215|NCT01591317|OG000|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
11101216|NCT01591317|OG001|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
11101217|NCT01591317|OG002|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
11101218|NCT01591317|OG000|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
11101219|NCT01591317|OG001|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
11101220|NCT01591317|OG002|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
11101221|NCT01591317|EG000|Reported Event|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
11101222|NCT01591317|EG001|Reported Event|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
11101223|NCT01591317|EG002|Reported Event|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
11101224|NCT01591330|BG000|Baseline|Overall Study|All participants
11101225|NCT01591330|FG000|Participant Flow|Sequence 1|"LY2140023 80 milligrams (mg) reference form (RF) in Period 1, LY2140023 80 mg Test-low in Period 2, LY2140023 80 mg Test-medium in Period 3, LY2140023 80 mg Test-high in Period 4.~Each LY2140023 dose was administered once, orally. There was a minimum 3-day washout period between dosing in one period and dosing in the next dosing period."
11003856|NCT01074164|EG001|Reported Event|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
11007778|NCT01092832|BG000|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
11007779|NCT01092832|BG001|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
11007780|NCT01092832|BG002|Baseline|Total|Total of all reporting groups
11007781|NCT01092832|FG000|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) with invasive candidiasis/candidemia (ICC) received a loading dose of voriconazole 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with esophageal candidiasis (EC) received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to oral (PO) therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
11007782|NCT01092832|FG001|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
11007783|NCT01092832|OG000|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
11007784|NCT01092832|OG001|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
11007785|NCT01092832|EG000|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
11007786|NCT01092832|EG001|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
11007787|NCT01092910|BG000|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11003857|NCT01074177|BG000|Baseline|BIBW 2992|BIBW 2992: Taken orally once a day
11003858|NCT01074177|FG000|Participant Flow|BIBW 2992|BIBW 2992: Taken orally once a day
11003859|NCT01074177|OG000|Outcome|BIBW 2992|BIBW 2992: Taken orally once a day
11003860|NCT01074177|EG000|Reported Event|BIBW 2992|BIBW 2992: Taken orally once a day
11003861|NCT01074216|BG000|Baseline|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
11003862|NCT01074216|FG000|Participant Flow|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
11003863|NCT01074216|OG000|Outcome|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
11003864|NCT01074216|EG000|Reported Event|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
11003865|NCT01074229|BG000|Baseline|Placebo|Group B (control group) will receive sterile normal saline.
11003866|NCT01074229|BG001|Baseline|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
11003867|NCT01074229|BG002|Baseline|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
11003868|NCT01074229|BG003|Baseline|Total|Total of all reporting groups
11003869|NCT01074229|FG000|Participant Flow|Placebo|Group B (control group) will receive sterile normal saline.
11003870|NCT01074229|FG001|Participant Flow|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
11003871|NCT01074229|FG002|Participant Flow|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
11003872|NCT01074229|OG000|Outcome|PLACEBO|Group B (control group) will receive sterile normal saline.
11003873|NCT01074229|OG001|Outcome|20 cc of 0.5% Ropivacaine|STUDY DRUG Group A (study group) 20 cc of 0.5% ropivacaine
11003874|NCT01074229|OG002|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
11003875|NCT01074229|OG000|Outcome|Placebo|Group B (control group) will receive sterile normal saline.
11003876|NCT01074229|OG001|Outcome|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
11003877|NCT01074229|EG000|Reported Event|Placebo|Group B (control group) will receive sterile normal saline.
11003878|NCT01074229|EG001|Reported Event|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
11003879|NCT01074229|EG002|Reported Event|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
11003880|NCT01074242|BG000|Baseline|Rotateq|Korean infants vaccinated with Rotateq in usual practice
11003881|NCT01074242|FG000|Participant Flow|Rotateq|Korean infants vaccinated with Rotateq in usual practice
11003882|NCT01074242|OG000|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
11003883|NCT01074242|EG000|Reported Event|Rotateq|Korean infants vaccinated with Rotateq in usual practice
11003884|NCT01074255|BG000|Baseline|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
11003885|NCT01074255|FG000|Participant Flow|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
11003886|NCT01074255|OG000|Outcome|Participants Treated With EMEND|
11003887|NCT01074255|EG000|Reported Event|Participants in the Safety Analysis|Participants included in the Safety Analysis
11003888|NCT01074268|BG000|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
11003889|NCT01074268|BG001|Baseline|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
11003890|NCT01074268|BG002|Baseline|Total|Total of all reporting groups
11003891|NCT01074268|FG000|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
11003892|NCT01074268|FG001|Participant Flow|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
11003893|NCT01074268|OG000|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
11003894|NCT01074268|OG001|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
11003895|NCT01074268|EG000|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
11101226|NCT01591330|FG001|Participant Flow|Sequence 2|"LY2140023 80 mg Test-low in Period 1, LY2140023 80 mg Test-high in Period 2, LY2140023 80 mg RF Period 3, LY2140023 80 mg Test-medium in Period 4.~Each LY2140023 dose was administered once, orally. There was a minimum 3-day washout period between dosing in one period and dosing in the next dosing period."
11101227|NCT01591330|FG002|Participant Flow|Sequence 3|"LY2140023 80 mg Test-high in Period 1, LY2140023 80 mg Test-medium in Period 2, LY2140023 80 mg Test-low in Period 3, LY2140023 80 mg RF in Period 4.~Each LY2140023 dose was administered once, orally. There was a minimum 3-day washout period between dosing in one period and dosing in the next dosing period."
11101228|NCT01591330|FG003|Participant Flow|Sequence 4|"LY2140023 80 mg Test-medium in Period 1, LY2140023 80 mg RF in Period 2, LY2140023 80 mg Test-high in Period 3, LY2140023 80 mg Test-low in Period 4.~Each LY2140023 dose was administered once, orally. There was a minimum 3-day washout period between dosing in one period and dosing in the next dosing period."
11101229|NCT01591330|OG000|Outcome|LY2140023 Reference Form|LY2140023: 80 milligrams (mg), administered once, orally.
11101230|NCT01591330|OG001|Outcome|LY2140023 Test-Low|LY2140023: 80 mg, low particle size, administered once, orally.
11101231|NCT01591330|OG002|Outcome|LY2140023 Test-Medium|LY2140023: 80 mg, medium particle size, administered once, orally.
11101232|NCT01591330|OG003|Outcome|LY2140023 Test-High|LY2140023: 80 mg, high particle size, administered once, orally.
11101233|NCT01591330|EG000|Reported Event|LY2140023 Reference Form|LY2140023: 80 mg, administered once, orally.
11101234|NCT01591330|EG001|Reported Event|LY2140023 Test-Low|LY2140023: 80 mg, low particle size, administered once, orally.
11101235|NCT01591330|EG002|Reported Event|LY2140023 Test-Medium|LY2140023: 80 mg, medium particle size, administered once, orally.
11101236|NCT01591330|EG003|Reported Event|LY2140023 Test-High|LY2140023: 80 mg, high particle size, administered once, orally.
11101237|NCT01591382|BG000|Baseline|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
11101238|NCT01591382|BG001|Baseline|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
11101239|NCT01591382|BG002|Baseline|Total|Total of all reporting groups
11101240|NCT01591382|FG000|Participant Flow|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
11101241|NCT01591382|FG001|Participant Flow|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
11101242|NCT01591382|OG000|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
11101243|NCT01591382|OG001|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
11101244|NCT01591382|EG000|Reported Event|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
11101245|NCT01591382|EG001|Reported Event|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
11101246|NCT01591408|BG000|Baseline|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
11101247|NCT01591408|BG001|Baseline|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
11101248|NCT01591408|BG002|Baseline|Total|Total of all reporting groups
11101249|NCT01591408|FG000|Participant Flow|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
11101250|NCT01591408|FG001|Participant Flow|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
11101251|NCT01591408|OG000|Outcome|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
11101252|NCT01591408|OG001|Outcome|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
11101253|NCT01591408|EG000|Reported Event|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
11101254|NCT01591408|EG001|Reported Event|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
10846713|NCT00279214|BG001|Baseline|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
10846714|NCT00279214|BG002|Baseline|Total|Total of all reporting groups
11126451|NCT01733329|EG000|Reported Event|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
11101255|NCT01591460|BG000|Baseline|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
11101256|NCT01591460|FG000|Participant Flow|Total Population|Treatment-naive participants with chronic hepatitis C (CHC) received treatment with peginterferon alfa-2a (PEG-IFN) 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based ribavirin (RBV) 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
11101257|NCT01591460|OG000|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
11101258|NCT01591460|OG001|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
11101259|NCT01591460|OG002|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
11101260|NCT01591460|OG003|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
11101261|NCT01591460|OG004|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
11101262|NCT01591460|OG005|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
11101263|NCT01591460|EG000|Reported Event|Cirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis.
10846715|NCT00279214|FG000|Participant Flow|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
10846716|NCT00279214|FG001|Participant Flow|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
10846717|NCT00279214|OG000|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
11101264|NCT01591460|EG001|Reported Event|Noncirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis.
11101265|NCT01591499|BG000|Baseline|Biofinity/Air Optix Aqua Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix or Air Optix crossover to Biofinity).
11101266|NCT01591499|BG001|Baseline|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision or Purevision crossover to Biofinity).
11101267|NCT01591499|BG002|Baseline|Total|Total of all reporting groups
11101268|NCT01591499|FG000|Participant Flow|Biofinity Then Air Optix|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
11101269|NCT01591499|FG001|Participant Flow|Air Optix Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
11101270|NCT01591499|FG002|Participant Flow|Biofinity Then Purevision|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
11101271|NCT01591499|FG003|Participant Flow|Purevision Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
11101272|NCT01591499|OG000|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
11101273|NCT01591499|OG001|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
11101274|NCT01591499|OG002|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
11101275|NCT01591499|OG000|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal)
11101276|NCT01591499|OG000|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
11101277|NCT01591499|OG000|Outcome|Biofinity Multifocal|Comfort performance by lens (Biofinity Multifocal) tested at V3 or V5
11101278|NCT01591499|OG001|Outcome|Air Optix Aqua Multifocal|Comfort performance by lens (Air Optix Aqua Multifocal)
11101279|NCT01591499|OG002|Outcome|Purevision Multifocal|Comfort performance by lens (Purevision Multifocal)
11101280|NCT01591499|OG000|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
11101281|NCT01591499|OG001|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
11101282|NCT01591499|OG002|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
11101283|NCT01591499|OG000|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
11101284|NCT01591499|OG001|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
11101285|NCT01591499|OG002|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
11101286|NCT01591499|OG000|Outcome|Biofinity Multifocal|Clinical performance by lens (Biofinity Multifocal) tested at V3 or V5
11101287|NCT01591499|OG001|Outcome|Air Optix Aqua Multifocal|Clinical performance by lens (Air Optix Aqua Multifocal)
11101288|NCT01591499|OG002|Outcome|Purevision Multifocal|Clinical performance by lens (Purevision Multifocal)
11101289|NCT01591499|OG000|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
11101290|NCT01591499|OG001|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
11101291|NCT01591499|OG002|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair.
11101292|NCT01591499|OG002|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair
11101293|NCT01591499|EG000|Reported Event|Overall Study Population|Population of patients having evaluated at least one lens
11101294|NCT01591616|BG000|Baseline|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
11101295|NCT01591616|FG000|Participant Flow|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
11101296|NCT01591616|OG000|Outcome|Lidocaine Cmax|
11101297|NCT01591616|OG001|Outcome|Prilocaine Cmax|
11101298|NCT01591616|OG002|Outcome|2,6-xylidine Cmax|
11101299|NCT01591616|OG003|Outcome|O-toluidine Cmax|
11101300|NCT01591616|OG000|Outcome|% MetHemoglobin (MetHb) Time Point -20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101301|NCT01591616|OG001|Outcome|% MetHemoglobin (MetHb) Time Point -10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101302|NCT01591616|OG002|Outcome|% MetHemoglobin (MetHb) Time Point 0 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101303|NCT01591616|OG003|Outcome|% MetHemoglobin (MetHb) Time Point 10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101304|NCT01591616|OG004|Outcome|% MetHemoglobin (MetHb) Time Point 20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101305|NCT01591616|OG005|Outcome|% MetHemoglobin (MetHb) Time Point 30 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101306|NCT01591616|OG006|Outcome|% MetHemoglobin (MetHb) Time Point 40 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101307|NCT01591616|OG007|Outcome|% MetHemoglobin (MetHb) Time Point 50 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101308|NCT01591616|OG008|Outcome|% MetHemoglobin (MetHb) Time Point 60 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101309|NCT01591616|OG009|Outcome|% MetHemoglobin (MetHb) Time Point 70 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101310|NCT01591616|OG010|Outcome|% MetHemoglobin (MetHb) Time Point 80 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101311|NCT01591616|OG011|Outcome|% MetHemoglobin (MetHb) Time Point 90 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101312|NCT01591616|OG012|Outcome|% MetHemoglobin (MetHb) Time Point 100 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101313|NCT01591616|OG013|Outcome|% MetHemoglobin (MetHb) Time Point 110 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101314|NCT01591616|OG014|Outcome|% MetHemoglobin (MetHb) Time Point 120 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101315|NCT01591616|OG015|Outcome|% MetHemoglobin (MetHb) Time Point 130 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101316|NCT01591616|OG016|Outcome|% MetHemoglobin (MetHb) Time Point 140 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101317|NCT01591616|OG017|Outcome|% MetHemoglobin (MetHb) Time Point 150 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101318|NCT01591616|OG018|Outcome|% MetHemoglobin (MetHb) Time Point 160 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101319|NCT01591616|OG019|Outcome|% MetHemoglobin (MetHb) Time Point 170 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101320|NCT01591616|OG020|Outcome|% MetHemoglobin (MetHb) Time Point 180 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101321|NCT01591616|OG021|Outcome|% MetHemoglobin (MetHb) Time Point 190 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101322|NCT01591616|OG022|Outcome|% MetHemoglobin (MetHb) Time Point 200 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101323|NCT01591616|OG023|Outcome|% MetHemoglobin (MetHb) Time Point 210 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101324|NCT01591616|OG024|Outcome|% MetHemoglobin (MetHb) Time Point 220 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101325|NCT01591616|OG025|Outcome|% MetHemoglobin (MetHb) Time Point 230 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101326|NCT01591616|OG026|Outcome|% MetHemoglobin (MetHb) Time Point 240 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
11101327|NCT01591616|OG000|Outcome|Lidocaine Tmax|
11101328|NCT01591616|OG001|Outcome|Prilocaine Tmax|
11101329|NCT01591616|OG002|Outcome|2,6-xylidine Tmax|
11101330|NCT01591616|OG003|Outcome|O-toluidine Tmax|
11101331|NCT01591616|OG000|Outcome|Vital Signs (Pulse Rate), - 20 Minutes Pre-dose|
11101332|NCT01591616|OG001|Outcome|Vital Signs (Pulse Rate), - 10 Minutes Pre-dose|
11101333|NCT01591616|OG002|Outcome|Vital Signs (Pulse Rate), 0 Minutes Pre-dose|
11101334|NCT01591616|OG003|Outcome|Vital Signs (Pulse Rate), 10 Minutes Post-dose|
11101335|NCT01591616|OG004|Outcome|Vital Signs (Pulse Rate), 20 Minutes Post-dose|
11101336|NCT01591616|OG005|Outcome|Vital Signs (Pulse Rate), 30 Minutes Post-dose|
11101337|NCT01591616|OG006|Outcome|Vital Signs (Pulse Rate), 40 Minutes Post-dose|
11101338|NCT01591616|OG007|Outcome|Vital Signs (Pulse Rate), 50 Minutes Post-dose|
11101339|NCT01591616|OG008|Outcome|Vital Signs (Pulse Rate), 60 Minutes Post-dose|
11101340|NCT01591616|OG009|Outcome|Vital Signs (Pulse Rate), 70 Minutes Post-dose|
11101341|NCT01591616|OG010|Outcome|Vital Signs (Pulse Rate), 80 Minutes Post-dose|
11101342|NCT01591616|OG011|Outcome|Vital Signs (Pulse Rate), 90 Minutes Post-dose|
11101343|NCT01591616|OG012|Outcome|Vital Signs (Pulse Rate), 100 Minutes Post-dose|
11101344|NCT01591616|OG013|Outcome|Vital Signs (Pulse Rate), 110 Minutes Post-dose|
11101345|NCT01591616|OG014|Outcome|Vital Signs (Pulse Rate), 120 Minutes Post-dose|
11101346|NCT01591616|OG015|Outcome|Vital Signs (Pulse Rate), 130 Minutes Post-dose|
11101347|NCT01591616|OG016|Outcome|Vital Signs (Pulse Rate), 140 Minutes Post-dose|
11101348|NCT01591616|OG017|Outcome|Vital Signs (Pulse Rate), 150 Minutes Post-dose|
11101349|NCT01591616|OG018|Outcome|Vital Signs (Pulse Rate), 160 Minutes Post-dose|
11101350|NCT01591616|OG019|Outcome|Vital Signs (Pulse Rate), 170 Minutes Post-dose|
11101351|NCT01591616|OG020|Outcome|Vital Signs (Pulse Rate), 180 Minutes Post-dose|
11101352|NCT01591616|OG021|Outcome|Vital Signs (Pulse Rate), 190 Minutes Post-dose|
11101353|NCT01591616|OG022|Outcome|Vital Signs (Pulse Rate), 200 Minutes Post-dose|
11101354|NCT01591616|OG023|Outcome|Vital Signs (Pulse Rate), 210 Minutes Post-dose|
11101355|NCT01591616|OG024|Outcome|Vital Signs (Pulse Rate), 220 Minutes Post-dose|
11101356|NCT01591616|OG025|Outcome|Vital Signs (Pulse Rate), 230 Minutes Post-dose|
11101357|NCT01591616|OG026|Outcome|Vital Signs (Pulse Rate), 240 Minutes Post-dose|
10846718|NCT00279214|OG001|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
11101358|NCT01591616|OG000|Outcome|Vital Signs (Systolic), - 20 Minutes Pre-dose|
11101359|NCT01591616|OG001|Outcome|Vital Signs (Systolic), - 10 Minutes Pre-dose|
11101360|NCT01591616|OG002|Outcome|Vital Signs (Systolic), 0 Minutes Pre-dose|
11101361|NCT01591616|OG003|Outcome|Vital Signs (Systolic), 10 Minutes Post-dose|
11101362|NCT01591616|OG004|Outcome|Vital Signs (Systolic), 20 Minutes Post-dose|
11101363|NCT01591616|OG005|Outcome|Vital Signs (Systolic), 30 Minutes Post-dose|
11101364|NCT01591616|OG006|Outcome|Vital Signs (Systolic), 40 Minutes Post-dose|
11101365|NCT01591616|OG007|Outcome|Vital Signs (Systolic), 50 Minutes Post-dose|
11101366|NCT01591616|OG008|Outcome|Vital Signs (Systolic), 60 Minutes Post-dose|
11101367|NCT01591616|OG009|Outcome|Vital Signs (Systolic), 70 Minutes Post-dose|
11101368|NCT01591616|OG010|Outcome|Vital Signs (Systolic) 80 Minutes Post-dose|
11101369|NCT01591616|OG011|Outcome|Vital Signs (Systolic), 90 Minutes Post-dose|
11101370|NCT01591616|OG012|Outcome|Vital Signs (Systolic), 100 Minutes Post-dose|
11101371|NCT01591616|OG013|Outcome|Vital Signs (Systolic), 110 Minutes Post-dose|
11101372|NCT01591616|OG014|Outcome|Vital Signs (Systolic), 120 Minutes Post-dose|
11101373|NCT01591616|OG015|Outcome|Vital Signs (Systolic), 130 Minutes Post-dose|
11101374|NCT01591616|OG016|Outcome|Vital Signs (Systolic), 140 Minutes Post-dose|
11101375|NCT01591616|OG017|Outcome|Vital Signs (Systolic), 150 Minutes Post-dose|
11101376|NCT01591616|OG018|Outcome|Vital Signs (Systolic), 160 Minutes Post-dose|
11101377|NCT01591616|OG019|Outcome|Vital Signs (Systolic), 170 Minutes Post-dose|
11101378|NCT01591616|OG020|Outcome|Vital Signs (Systolic), 180 Minutes Post-dose|
11101379|NCT01591616|OG021|Outcome|Vital Signs (Systolic), 190 Minutes Post-dose|
11101380|NCT01591616|OG022|Outcome|Vital Signs (Systolic), 200 Minutes Post-dose|
11101381|NCT01591616|OG023|Outcome|Vital Signs (Systolic), 210 Minutes Post-dose|
11101382|NCT01591616|OG024|Outcome|Vital Signs (Systolic), 220 Minutes Post-dose|
11101383|NCT01591616|OG025|Outcome|Vital Signs (Systolic), 230 Minutes Post-dose|
11101384|NCT01591616|OG026|Outcome|Vital Signs (Systolic), 240 Minutes Post-dose|
11101385|NCT01591616|OG000|Outcome|Vital Signs (Diastolic), - 20 Minutes Pre-dose|
11101386|NCT01591616|OG001|Outcome|Vital Signs (Diastolic), - 10 Minutes Pre-dose|
11101387|NCT01591616|OG002|Outcome|Vital Signs (Diastolic), 0 Minutes Pre-dose|
11101388|NCT01591616|OG003|Outcome|Vital Signs (Diastolic), 10 Minutes Post-dose|
11101389|NCT01591616|OG004|Outcome|Vital Signs (Diastolic), 20 Minutes Post-dose|
11101390|NCT01591616|OG005|Outcome|Vital Signs (Diastolic), 30 Minutes Post-dose|
11101391|NCT01591616|OG006|Outcome|Vital Signs (Diastolic), 40 Minutes Post-dose|
11101392|NCT01591616|OG007|Outcome|Vital Signs (Diastolic), 50 Minutes Post-dose|
11101393|NCT01591616|OG008|Outcome|Vital Signs Diastolic(), 60 Minutes Post-dose|
11101394|NCT01591616|OG009|Outcome|Vital Signs (Diastolic), 70 Minutes Post-dose|
11101395|NCT01591616|OG010|Outcome|Vital Signs (Diastolic) 80 Minutes Post-dose|
11101396|NCT01591616|OG011|Outcome|Vital Signs (Diastolic), 90 Minutes Post-dose|
11101397|NCT01591616|OG012|Outcome|Vital Signs (Diastolic), 100 Minutes Post-dose|
11101398|NCT01591616|OG013|Outcome|Vital Signs (Diastolic), 110 Minutes Post-dose|
11101399|NCT01591616|OG014|Outcome|Vital Signs (Diastolic), 120 Minutes Post-dose|
11101400|NCT01591616|OG015|Outcome|Vital Signs Diastolic(), 130 Minutes Post-dose|
11101401|NCT01591616|OG016|Outcome|Vital Signs (Diastolic), 140 Minutes Post-dose|
11101402|NCT01591616|OG017|Outcome|Vital Signs (Diastolic), 150 Minutes Post-dose|
11101403|NCT01591616|OG018|Outcome|Vital Signs (Diastolic), 160 Minutes Post-dose|
11101404|NCT01591616|OG019|Outcome|Vital Signs (Diastolic), 170 Minutes Post-dose|
11101405|NCT01591616|OG020|Outcome|Vital Signs (Diastolic), 180 Minutes Post-dose|
11101406|NCT01591616|OG021|Outcome|Vital Signs (Diastolic), 190 Minutes Post-dose|
11101407|NCT01591616|OG022|Outcome|Vital Signs (Diastolic), 200 Minutes Post-dose|
11101408|NCT01591616|OG023|Outcome|Vital Signs (Diastolic), 210 Minutes Post-dose|
11101409|NCT01591616|OG024|Outcome|Vital Signs (Diastolic), 220 Minutes Post-dose|
11101410|NCT01591616|OG025|Outcome|Vital Signs (Diastolic), 230 Minutes Post-dose|
11101411|NCT01591616|OG026|Outcome|Vital Signs (Diastolic), 240 Minutes Post-dose|
11003896|NCT01074268|EG001|Reported Event|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
11003897|NCT01074307|BG000|Baseline|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
11003898|NCT01074307|BG001|Baseline|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
11003899|NCT01074307|BG002|Baseline|Total|Total of all reporting groups
11003900|NCT01074307|FG000|Participant Flow|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
11003901|NCT01074307|FG001|Participant Flow|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
11003902|NCT01074307|OG000|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
11003903|NCT01074307|OG001|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
11003904|NCT01074307|EG000|Reported Event|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
11003905|NCT01074307|EG001|Reported Event|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
11003906|NCT01074450|BG000|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
11003907|NCT01074450|BG001|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
11003908|NCT01074450|BG002|Baseline|Total|Total of all reporting groups
11101412|NCT01591616|OG000|Outcome|Ventricular Heart Rate, Pre-dose|
11003909|NCT01074450|FG000|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
11003910|NCT01074450|FG001|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
11003911|NCT01074450|OG000|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
11003912|NCT01074450|OG001|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
11003913|NCT01074450|EG000|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
11003914|NCT01074450|EG001|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
11003915|NCT01074463|BG000|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
11003916|NCT01074463|BG001|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
11003917|NCT01074463|BG002|Baseline|Total|Total of all reporting groups
11003918|NCT01074463|FG000|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
11003919|NCT01074463|FG001|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
11003920|NCT01074463|OG000|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
11003921|NCT01074463|OG001|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
10846719|NCT00279214|EG000|Reported Event|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
10846720|NCT00279214|EG001|Reported Event|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
10846721|NCT00279305|BG000|Baseline|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
11003922|NCT01074463|EG000|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
11003923|NCT01074463|EG001|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
11003924|NCT01074554|BG000|Baseline|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
11003925|NCT01074554|BG001|Baseline|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
11003926|NCT01074554|BG002|Baseline|Total|Total of all reporting groups
11003927|NCT01074554|FG000|Participant Flow|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
11003928|NCT01074554|FG001|Participant Flow|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
11003929|NCT01074554|OG000|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
11003930|NCT01074554|OG001|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
11003931|NCT01074554|EG000|Reported Event|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
11003932|NCT01074554|EG001|Reported Event|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
11003933|NCT01074658|BG000|Baseline|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
11003934|NCT01074658|FG000|Participant Flow|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
11003935|NCT01074658|OG000|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
11003936|NCT01074658|EG000|Reported Event|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
11003937|NCT01074931|BG000|Baseline|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
11003938|NCT01074931|FG000|Participant Flow|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
11003939|NCT01074931|OG000|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
11003940|NCT01074931|OG001|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
11003941|NCT01074931|OG000|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
11003942|NCT01074931|OG000|Outcome|Lopinavir/Ritonavir Group: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
11003943|NCT01074931|OG001|Outcome|Lopinavir/Ritonavir Group: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
11003944|NCT01074931|EG000|Reported Event|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
11003945|NCT01074944|BG000|Baseline|All Participants|All participants who received treatment in LIP (eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks [except for the participants in Japan]. Participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks) and assessed for randomization.
11003946|NCT01074944|FG000|Participant Flow|LIP, Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual pharmacokinetics (PK) data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
11003947|NCT01074944|FG001|Participant Flow|PAP, Eliglustat: Once Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP received eliglustat capsules at the total daily dose (TDD) of 100 mg or 200 mg (the TDD they were on before randomization) once daily (QD) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
11003948|NCT01074944|FG002|Participant Flow|PAP, Eliglustat: Twice Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP, received eliglustat at the TDD 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
11101413|NCT01591616|OG001|Outcome|Ventricular Heart Rate, 1 Hour Post-dose|
11101414|NCT01591616|OG002|Outcome|Ventricular Heart Rate, 2 Hour Post-dose|
11003949|NCT01074944|FG003|Participant Flow|LTTP, Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
11003950|NCT01074944|FG004|Participant Flow|ETP, Eliglustat|All participants who did not meet all the randomization criteria at Week 78 of the LIP continued in the ETP and received eliglustat capsules at the same dose as they were receiving at the end of LIP till the end of the study.
11003951|NCT01074944|OG000|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
11003952|NCT01074944|OG001|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
11003953|NCT01074944|OG000|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
11003954|NCT01074944|OG000|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
11003955|NCT01074944|OG000|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
11003956|NCT01074944|EG000|Reported Event|Eliglustat|All participants who received eliglustat at the TDD of 100 mg or 200 mg in the LIP, PAP, LTTP or ETP.
11003957|NCT01075048|BG000|Baseline|Phase 1: ARQ 197+Cetuximab+Irinotecan|Participants received an oral dose of ARQ197 capsules twice daily (BID) with a meal, in escalating doses of 120 milligram (mg), 240 mg, and 360 mg to 3 separate cohorts on Day 1 of Cycle 1 and Cycle 2. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed by 60 minutes with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003958|NCT01075048|BG001|Baseline|Phase 2: Placebo+Cetuximab+Irinotecan|Participants received placebo twice daily (BID) with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/ m^2 intravenous infusion over 120 minutes, then over 60 minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003959|NCT01075048|BG002|Baseline|Phase 2: ARQ 197+Cetuximab+Irinotecan|Participants received ARQ197 (recommended Phase 2 dose of 720 mg) daily with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and Irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003960|NCT01075048|BG003|Baseline|Total|Total of all reporting groups
11003961|NCT01075048|FG000|Participant Flow|Phase 1: ARQ 197+Cetuximab+Irinotecan|Participants received an oral dose of ARQ197 capsules twice daily (BID) with a meal, in escalating doses of 120 milligram (mg), 240 mg, and 360 mg to 3 separate cohorts on Day 1 of Cycle 1 and Cycle 2. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed by 60 minutes with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003962|NCT01075048|FG001|Participant Flow|Phase 2: Placebo+Cetuximab+Irinotecan|Participants received placebo twice daily (BID) with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/ m^2 intravenous infusion over 120 minutes, then over 60 minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003963|NCT01075048|FG002|Participant Flow|Phase 2: ARQ 197+Cetuximab+Irinotecan|Participants received ARQ197 (recommended Phase 2 dose of 720 mg) daily with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and Irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11101415|NCT01591616|OG003|Outcome|Ventricular Heart Rate, 4 Hour Post-dose|
11101416|NCT01591616|OG000|Outcome|PR Interval, Pre-dose|
11101417|NCT01591616|OG001|Outcome|PR Interval, 1 Hour Post-dose|
11101418|NCT01591616|OG002|Outcome|PR Interval, 2 Hour Post-dose|
11101419|NCT01591616|OG003|Outcome|PR Interval, 4 Hour Post-dose|
11101420|NCT01591616|OG000|Outcome|QRS Duration, Pre-dose|
11101421|NCT01591616|OG001|Outcome|QRS Duration, 1 Hour Post-dose|
11101422|NCT01591616|OG002|Outcome|QRS Duration, 2 Hour Post-dose|
11101423|NCT01591616|OG003|Outcome|QRS Duration, 4 Hour Post-dose|
11101424|NCT01591616|OG000|Outcome|QT Interval, Pre-dose|
11101425|NCT01591616|OG001|Outcome|QT Interval, 1 Hour Post-dose|
11101426|NCT01591616|OG002|Outcome|QT Interval, 2 Hour Post-dose|
11101427|NCT01591616|OG003|Outcome|QT Interval, 4 Hour Post-dose|
11101428|NCT01591616|OG000|Outcome|QTcB Interval, Pre-dose|
11101429|NCT01591616|OG001|Outcome|QTcB Interval, 1 Hour Post-dose|
11101430|NCT01591616|OG002|Outcome|QTcB Interval, 2 Hour Post-dose|
11101431|NCT01591616|OG003|Outcome|QTcB Interval, 4 Hour Post-dose|
11101432|NCT01591616|EG000|Reported Event|Adverse Events|
11101433|NCT01591655|BG000|Baseline|Mapracorat|"Mapracorat ophthalmic suspension, 3%,~Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days"
10879520|NCT00458341|BG000|Baseline|Ataluren 4, 4, and 8 mg/kg, Then Ataluren 10, 10, and 20 mg/kg|During Cycle 1, participants received ataluren at 4 mg/kg in the morning, 4 mg/kg at midday, and 8 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. Then, the participants crossed over to the other ataluren dose regimen (ataluren 10, 10, and 20 mg/kg) for Cycle 2.
11101434|NCT01591655|BG001|Baseline|Vehicle|"The vehicle of the mapracorat ophthalmic suspension~Vehicle: 1 drop of vehicle into the study eye QID for 14 days."
11101435|NCT01591655|BG002|Baseline|Total|Total of all reporting groups
11101436|NCT01591655|FG000|Participant Flow|Mapracorat|"Mapracorat ophthalmic suspension, 3%,~Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days"
11101437|NCT01591655|FG001|Participant Flow|Vehicle|"The vehicle of the mapracorat ophthalmic suspension~Vehicle: 1 drop of vehicle into the study eye QID for 14 days."
11101438|NCT01591655|OG000|Outcome|Mapracorat|"Mapracorat ophthalmic suspension, 3%,~Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days"
11101439|NCT01591655|OG001|Outcome|Vehicle|"The vehicle of the mapracorat ophthalmic suspension~Vehicle: 1 drop of vehicle into the study eye QID for 14 days."
11101440|NCT01591655|EG000|Reported Event|Mapracorat|"Mapracorat ophthalmic suspension, 3%,~Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days"
11101441|NCT01591655|EG001|Reported Event|Vehicle|"The vehicle of the mapracorat ophthalmic suspension~Vehicle: 1 drop of vehicle into the study eye QID for 14 days."
11101442|NCT01591681|BG000|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11101443|NCT01591681|FG000|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11101444|NCT01591681|OG000|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
11101445|NCT01591681|OG001|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
11101446|NCT01591681|EG000|Reported Event|Pump Suspension Algorithm|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.)
11101447|NCT01591681|EG001|Reported Event|Standard of Care|On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11101448|NCT01591733|BG000|Baseline|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
11101449|NCT01591733|FG000|Participant Flow|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
11101450|NCT01591733|OG000|Outcome|All Eligible - FOLFIRINOX + Radiation|"The overall study population~All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
11101451|NCT01591733|OG001|Outcome|Resected Participants - FOLFIRINOX + Radiation|"The participants that were resected.~All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
11101452|NCT01591733|OG000|Outcome|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
11101453|NCT01591733|EG000|Reported Event|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
11101454|NCT01591746|BG000|Baseline|Group A - Botulinum Toxin Type A|"100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast~Botulinum Toxin Type A"
11101455|NCT01591746|BG001|Baseline|Group B - Placebo|"5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast~Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A"
11101456|NCT01591746|BG002|Baseline|Total|Total of all reporting groups
11101457|NCT01591746|FG000|Participant Flow|Group A - Botulinum Toxin Type A|"100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast~Botulinum Toxin Type A"
11101458|NCT01591746|FG001|Participant Flow|Group B - Placebo|"5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast~Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A"
11101459|NCT01591746|OG000|Outcome|Group A - Botulinum Toxin Type A|"100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast~Botulinum Toxin Type A"
11101460|NCT01591746|OG001|Outcome|Group B - Placebo|"5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast~Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A"
11101461|NCT01591746|EG000|Reported Event|Group A - Botulinum Toxin Type A|"100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast~Botulinum Toxin Type A"
11101462|NCT01591746|EG001|Reported Event|Group B - Placebo|"5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast~Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A"
11101463|NCT01591785|BG000|Baseline|Retapamulin 1% Ointment|twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
11101464|NCT01591785|BG001|Baseline|Placebo Ointment|twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
11101465|NCT01591785|BG002|Baseline|Total|Total of all reporting groups
11101466|NCT01591785|FG000|Participant Flow|Retapamulin 1% Ointment|twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
11101467|NCT01591785|FG001|Participant Flow|Placebo Ointment|twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
11101468|NCT01591785|OG000|Outcome|Retapamulin 1% Ointment|twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
11101469|NCT01591785|OG001|Outcome|Placebo Ointment|twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
11101470|NCT01591785|EG000|Reported Event|Retapamulin 1% Ointment|twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
11101471|NCT01591785|EG001|Reported Event|Placebo Ointment|twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
11101472|NCT01591837|BG000|Baseline|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11101473|NCT01591837|BG001|Baseline|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11101474|NCT01591837|BG002|Baseline|Total|Total of all reporting groups
11101475|NCT01591837|FG000|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11101476|NCT01591837|FG001|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11101477|NCT01591837|OG000|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11101478|NCT01591837|OG001|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11101479|NCT01591837|EG000|Reported Event|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11101480|NCT01591837|EG001|Reported Event|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11101481|NCT01591863|BG000|Baseline|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
11101482|NCT01591863|FG000|Participant Flow|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
11101483|NCT01591863|OG000|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
11101484|NCT01591863|EG000|Reported Event|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
11007788|NCT01092910|FG000|Participant Flow|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
11007789|NCT01092910|OG000|Outcome|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System~The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
11007790|NCT01092910|OG000|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
11007791|NCT01092910|EG000|Reported Event|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
11007792|NCT01092923|BG000|Baseline|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
11007793|NCT01092923|BG001|Baseline|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
11007794|NCT01092923|BG002|Baseline|Total|Total of all reporting groups
11007795|NCT01092923|FG000|Participant Flow|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
11007796|NCT01092923|FG001|Participant Flow|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
11007797|NCT01092923|OG000|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
11007798|NCT01092923|OG001|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
11007799|NCT01092923|OG000|Outcome|Sevoflurane in N2O/O2|sevoflurane with N20 and Oxygen in 2:1 mix
11007800|NCT01092923|OG001|Outcome|Sevoflurane in Air/O2|sevoflurane in air/O2 mix
11007801|NCT01092923|EG000|Reported Event|N20 With Oxygen (2:1)|sevoflurane with N20 and Oxygen in 2:1 mix
11007802|NCT01093014|BG000|Baseline|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
11007803|NCT01093014|BG001|Baseline|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
11007804|NCT01093014|BG002|Baseline|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
11007805|NCT01093014|BG003|Baseline|Total|Total of all reporting groups
11007806|NCT01093014|FG000|Participant Flow|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
11007807|NCT01093014|FG001|Participant Flow|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
11007808|NCT01093014|FG002|Participant Flow|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
11007809|NCT01093014|OG000|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
11007810|NCT01093014|OG001|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
11007811|NCT01093014|OG002|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
11007812|NCT01093014|OG000|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
11007813|NCT01093014|OG001|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
11007814|NCT01093014|OG002|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
11007815|NCT01093014|EG000|Reported Event|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
11007816|NCT01093014|EG001|Reported Event|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
11007817|NCT01093014|EG002|Reported Event|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
11007818|NCT01093027|BG000|Baseline|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
11007819|NCT01093027|BG001|Baseline|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
11007820|NCT01093027|BG002|Baseline|Total|Total of all reporting groups
11007821|NCT01093027|FG000|Participant Flow|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
11007822|NCT01093027|FG001|Participant Flow|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
11007823|NCT01093027|OG000|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
11007824|NCT01093027|OG001|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
11007825|NCT01093027|EG000|Reported Event|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
11007826|NCT01093027|EG001|Reported Event|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
11007827|NCT01093183|BG000|Baseline|Treatment (Lenalidomide and Cyclophosphamide)|"Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~lenalidomide and cyclophosphamide: Given PO"
11101485|NCT01592006|BG000|Baseline|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
11101486|NCT01592006|FG000|Participant Flow|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
11101487|NCT01592006|OG000|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
11101488|NCT01592006|EG000|Reported Event|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
11101489|NCT01592045|BG000|Baseline|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
11101490|NCT01592045|BG001|Baseline|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
11101491|NCT01592045|BG002|Baseline|Total|Total of all reporting groups
11101492|NCT01592045|FG000|Participant Flow|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
11101493|NCT01592045|FG001|Participant Flow|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
11101494|NCT01592045|OG000|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
11101495|NCT01592045|OG001|Outcome|NCI ch14.18|NCI Manufactured ch14.18
11101496|NCT01592045|EG000|Reported Event|UTC ch14.18|United Therapeutics Manufactured ch14.18
11101497|NCT01592045|EG001|Reported Event|NCI ch14.18|NCI Manufactured ch14.18
11101498|NCT01592071|BG000|Baseline|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
11101499|NCT01592071|FG000|Participant Flow|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
11101500|NCT01592071|OG000|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
11101501|NCT01592071|EG000|Reported Event|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
11101502|NCT01592240|BG000|Baseline|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
11101503|NCT01592240|BG001|Baseline|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
11101504|NCT01592240|BG002|Baseline|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
11101505|NCT01592240|BG003|Baseline|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
11101506|NCT01592240|BG004|Baseline|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
11101507|NCT01592240|BG005|Baseline|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
11101508|NCT01592240|BG006|Baseline|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
11101509|NCT01592240|BG007|Baseline|Total|Total of all reporting groups
11101510|NCT01592240|FG000|Participant Flow|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
11101511|NCT01592240|FG001|Participant Flow|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
11101512|NCT01592240|FG002|Participant Flow|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
11101513|NCT01592240|FG003|Participant Flow|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
11101514|NCT01592240|FG004|Participant Flow|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
11101515|NCT01592240|FG005|Participant Flow|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
11101516|NCT01592240|FG006|Participant Flow|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
11101517|NCT01592240|OG000|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
11101518|NCT01592240|OG001|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
11101519|NCT01592240|OG002|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
11101520|NCT01592240|OG003|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
11101521|NCT01592240|OG004|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
11101522|NCT01592240|OG005|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
11101523|NCT01592240|OG006|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
11101524|NCT01592240|OG000|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
11101525|NCT01592240|OG001|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
11101526|NCT01592240|OG002|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
11101527|NCT01592240|OG003|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
11101528|NCT01592240|OG004|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
11101529|NCT01592240|EG000|Reported Event|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
11101530|NCT01592240|EG001|Reported Event|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
11101531|NCT01592240|EG002|Reported Event|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
11101532|NCT01592240|EG003|Reported Event|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
11101533|NCT01592240|EG004|Reported Event|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
11101534|NCT01592240|EG005|Reported Event|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
11101535|NCT01592240|EG006|Reported Event|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
11101536|NCT01592292|BG000|Baseline|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
11101537|NCT01592292|BG001|Baseline|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
11101538|NCT01592292|BG002|Baseline|Total|Total of all reporting groups
11101539|NCT01592292|FG000|Participant Flow|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
10879521|NCT00458341|BG001|Baseline|Ataluren 10, 10, and 20 mg/kg, Then Ataluren 4, 4, and 8 mg/kg|During Cycle 1, participants received ataluren at 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. Then, the participants crossed over to the other ataluren dose regimen (ataluren 4, 4, and 8 mg/kg) for Cycle 2.
11101540|NCT01592292|FG001|Participant Flow|Other Anti-TNF Agent: Adalimumab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician's discretion for RA treatment were observed for 12 months.
11101541|NCT01592292|FG002|Participant Flow|Other Anti-TNF Agent: Etanercept|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician's discretion for RA treatment were observed for 12 months.
11101542|NCT01592292|FG003|Participant Flow|Other Anti-TNF Agent: Infliximab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician's discretion for RA treatment were observed for 12 months.
11101543|NCT01592292|OG000|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
11101544|NCT01592292|OG001|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
11101545|NCT01592292|EG000|Reported Event|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
11101546|NCT01592292|EG001|Reported Event|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
11101547|NCT01592344|BG000|Baseline|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
11101548|NCT01592344|BG001|Baseline|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
11101549|NCT01592344|BG002|Baseline|Total|Total of all reporting groups
11101550|NCT01592344|FG000|Participant Flow|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
11101551|NCT01592344|FG001|Participant Flow|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
11101552|NCT01592344|OG000|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
11101553|NCT01592344|OG001|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
11101554|NCT01592344|EG000|Reported Event|StimRouter Active Stimulation|"The stimulation program settings for the active stimulation arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
11101555|NCT01592344|EG001|Reported Event|StimRouter Control|"The stimulation program settings for the control arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
11101556|NCT01592396|BG000|Baseline|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
11101557|NCT01592396|BG001|Baseline|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
11101558|NCT01592396|BG002|Baseline|Total|Total of all reporting groups
11101559|NCT01592396|FG000|Participant Flow|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
11101560|NCT01592396|FG001|Participant Flow|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
10879522|NCT00458341|BG002|Baseline|Total|Total of all reporting groups
11101561|NCT01592396|OG000|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
11101562|NCT01592396|OG001|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
11101563|NCT01592396|OG000|Outcome|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
11101564|NCT01592396|OG000|Outcome|Tralokinumab 300mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
11101565|NCT01592396|EG000|Reported Event|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
11101566|NCT01592409|BG000|Baseline|Active Cannabis|"In this condition, participants will receive a cigarette containing 12.5% active THC.~delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose."
11101567|NCT01592409|BG001|Baseline|Placebo|"In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).~Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study)."
11101568|NCT01592409|BG002|Baseline|Total|Total of all reporting groups
11101569|NCT01592409|FG000|Participant Flow|Active Cannabis|"In this condition, participants will receive a cigarette containing 12.5% active THC.~delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose."
11101570|NCT01592409|FG001|Participant Flow|Placebo|"In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).~Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study)."
11101571|NCT01592409|OG000|Outcome|Active Cannabis|"In this condition, participants will receive a cigarette containing 12.5% active THC.~delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose."
11101572|NCT01592409|OG001|Outcome|Placebo|"In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).~Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study)."
11101573|NCT01592409|EG000|Reported Event|Active Cannabis|"In this condition, participants will receive a cigarette containing 12.5% active THC.~delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose."
11101574|NCT01592409|EG001|Reported Event|Placebo|"In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).~Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study)."
11101575|NCT01592435|BG000|Baseline|Pred. & Invest.-All Study Participants|"Cedera AccuStitch Software is standard of care software currently used at sites.~Carestream DR LLI software is investigational software used for reconstruction"
11101576|NCT01592435|FG000|Participant Flow|Pred. & Invest.-All Study Participants|"Cedera AccuStitch Software is standard of care software currently used at sites.~Carestream DR LLI software is investigational software used for reconstruction."
11101577|NCT01592435|OG000|Outcome|Predicate - Cedera AccuStitch Software|Cedera AccuStitch Software is standard of care software currently used at sites.
11101578|NCT01592435|OG000|Outcome|Invest. - Carestream DR LLI Software|Carestream DR LLI software is investigational software used for reconstruction.
11101579|NCT01592435|EG000|Reported Event|Predicate - Cedera AccuStitch Software|Cedara Accustitch is the standard of care software currently used by sites.
11101580|NCT01592435|EG001|Reported Event|Invest. - Carestream DR LLI Software|Carestream DR LLI software is investigational software used for reconstruction.
11101581|NCT01592500|BG000|Baseline|MOD-4023 Low Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101582|NCT01592500|BG001|Baseline|MOD-4023 Middle Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101583|NCT01592500|BG002|Baseline|MOD-4023 High Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101584|NCT01592500|BG003|Baseline|Genotropin|Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
11101585|NCT01592500|BG004|Baseline|Total|Total of all reporting groups
11101586|NCT01592500|FG000|Participant Flow|MOD-4023 Low Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101587|NCT01592500|FG001|Participant Flow|MOD-4023 Middle Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101588|NCT01592500|FG002|Participant Flow|MOD-4023 High Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101589|NCT01592500|FG003|Participant Flow|Genotropin|Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
11101590|NCT01592500|OG000|Outcome|MOD-4023 Low Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101591|NCT01592500|OG001|Outcome|MOD-4023 Middle Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101592|NCT01592500|OG002|Outcome|MOD-4023 High Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101593|NCT01592500|OG003|Outcome|Genotropin|Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
11101594|NCT01592500|EG000|Reported Event|MOD-4023 Low Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101595|NCT01592500|EG001|Reported Event|MOD-4023 Middle Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101596|NCT01592500|EG002|Reported Event|MOD-4023 High Dose|Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
11101597|NCT01592500|EG003|Reported Event|Genotropin|Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
11101598|NCT01592695|BG000|Baseline|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
11101599|NCT01592695|BG001|Baseline|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
11101600|NCT01592695|BG002|Baseline|Total|Total of all reporting groups
11101601|NCT01592695|FG000|Participant Flow|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tailored behavioral intervention: Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules treatment modules to address common issues associated with cigarette smoking based on individual need and preference. Individual treatment models address alcohol risk reduction, elevated depressive symptoms, and concerns about weight gain."
11101602|NCT01592695|FG001|Participant Flow|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
11101603|NCT01592695|OG000|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
11101604|NCT01592695|OG001|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
11101605|NCT01592695|EG000|Reported Event|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
11101606|NCT01592695|EG001|Reported Event|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
11101607|NCT01592708|BG000|Baseline|Intervention Cohort|This arm was managed perioperatively with the protocol.
11101608|NCT01592708|BG001|Baseline|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
11101609|NCT01592708|BG002|Baseline|Total|Total of all reporting groups
11101610|NCT01592708|FG000|Participant Flow|Intervention Cohort|Patients undergoing maxillary surgery using antiemetic anesthesia protocol
11101611|NCT01592708|FG001|Participant Flow|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
11101612|NCT01592708|OG000|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
11101613|NCT01592708|OG001|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
11101614|NCT01592708|OG000|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary.
11101615|NCT01592708|OG001|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
11101616|NCT01592708|OG000|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary
11101617|NCT01592708|EG000|Reported Event|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthesia protocol
11101618|NCT01592708|EG001|Reported Event|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
11101619|NCT01592747|BG000|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
11101620|NCT01592747|BG001|Baseline|Memantine Reduced Dose|Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day.
11101621|NCT01592747|BG002|Baseline|Memantine Full-Dose|Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day.
11101622|NCT01592747|BG003|Baseline|Total|Total of all reporting groups
11101623|NCT01592747|FG000|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
11101624|NCT01592747|FG001|Participant Flow|Memantine Reduced Dose|Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day.
11101625|NCT01592747|FG002|Participant Flow|Memantine Full-Dose|Memantine, 3mg, 6mg, 9mg, 12mg or 15mg, depending on weight group and tolerability. Oral administration, once per day.
11101626|NCT01592747|OG000|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
11101627|NCT01592747|OG001|Outcome|Memantine Reduced Dose|Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
11101628|NCT01592747|OG002|Outcome|Memantine Full-Dose|Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
11101629|NCT01592747|OG002|Outcome|Memantine Full-Dose|Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day.
11101630|NCT01592747|EG000|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
11101631|NCT01592747|EG001|Reported Event|Memantine Reduced Dose|Memantine, 3mg every other day, 3mg per day, or 6mg per day. Oral administration.
11101632|NCT01592747|EG002|Reported Event|Memantine Full-Dose|Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
11101633|NCT01592760|BG000|Baseline|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
11101634|NCT01592760|BG001|Baseline|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
11101635|NCT01592760|BG002|Baseline|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)~i-gel: i-gel placement for airway maintenance."
11101636|NCT01592760|BG003|Baseline|Total|Total of all reporting groups
11101637|NCT01592760|FG000|Participant Flow|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
11101638|NCT01592760|FG001|Participant Flow|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
11101639|NCT01592760|FG002|Participant Flow|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
11101640|NCT01592760|OG000|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
11101641|NCT01592760|OG001|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
11101642|NCT01592760|OG002|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
11101643|NCT01592760|OG000|Outcome|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
11101644|NCT01592760|OG001|Outcome|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q: air-Q placement for airway maintenance."
11101645|NCT01592760|OG002|Outcome|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)~i-gel: i-gel placement for airway maintenance."
11101646|NCT01592760|EG000|Reported Event|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
11101647|NCT01592760|EG001|Reported Event|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
11101648|NCT01592760|EG002|Reported Event|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
11101649|NCT01592773|BG000|Baseline|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
11101650|NCT01592773|FG000|Participant Flow|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
11101651|NCT01592773|OG000|Outcome|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
11101652|NCT01592773|EG000|Reported Event|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
11101653|NCT01592786|BG000|Baseline|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
10846722|NCT00279305|BG001|Baseline|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
11101654|NCT01592786|FG000|Participant Flow|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
11101655|NCT01592786|OG000|Outcome|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg per day, based upon patient weight.
11101656|NCT01592786|EG000|Reported Event|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg, once per day, based upon patient weight.
11101657|NCT01592799|BG000|Baseline|Influenza Group|Children less than (<) 15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season.
11101658|NCT01592799|FG000|Participant Flow|Influenza Group|Children <15 years of age hospitalized for or presenting to an Emergency Room (ER) for Acute Respiratory Illness (ARI) and/or isolated fever during the influenza season.
11101659|NCT01592799|OG000|Outcome|Influenza Group|Children <15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.
11101660|NCT01592799|OG000|Outcome|Influenza Positive Group|Children <15 years of age with at least one laboratory test positive for influenza.
11101661|NCT01592799|OG001|Outcome|Influenza Negative Group|Children <15 years of age with no laboratory test positive for influenza.
11101662|NCT01592799|EG000|Reported Event|Influenza Group|Children <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season.
11101663|NCT01592851|BG000|Baseline|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
11101664|NCT01592851|BG001|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
11101665|NCT01592851|BG002|Baseline|Total|Total of all reporting groups
11101666|NCT01592851|FG000|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
11101667|NCT01592851|FG001|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% Sodium Monofluorophosphate [NaMFP]) for one timed minute, followed by rinsing with 5 mL of water.
11101668|NCT01592851|OG000|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
11101669|NCT01592851|OG001|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
11101670|NCT01592851|EG000|Reported Event|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
11101671|NCT01592851|EG001|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
11101672|NCT01592864|BG000|Baseline|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
11101673|NCT01592864|BG001|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
11101674|NCT01592864|BG002|Baseline|Total|Total of all reporting groups
11101675|NCT01592864|FG000|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 milliliter (mL) of water.
11101676|NCT01592864|FG001|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
11101677|NCT01592864|OG000|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
11101678|NCT01592864|OG001|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
11101679|NCT01592864|EG000|Reported Event|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
11101680|NCT01592864|EG001|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
11101681|NCT01593020|BG000|Baseline|Paclitaxel Weekly for 12 Doses Followed by FAC/FEC|Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.
11101682|NCT01593020|BG001|Baseline|Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC|Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
11101683|NCT01593020|BG002|Baseline|Total|Total of all reporting groups
11101684|NCT01593020|FG000|Participant Flow|Paclitaxel Weekly for 12 Doses Followed by FAC/FEC|Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.
11101685|NCT01593020|FG001|Participant Flow|Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC|Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
11101686|NCT01593020|OG000|Outcome|Paclitaxel Weekly for 12 Doses Followed by FAC/FEC|Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.
11101687|NCT01593020|OG001|Outcome|Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC|Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
11101688|NCT01593020|EG000|Reported Event|Paclitaxel Weekly for 12 Doses Followed by FAC/FEC|Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.
11101689|NCT01593020|EG001|Reported Event|Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC|Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
11101690|NCT01593215|BG000|Baseline|Placebo First Then Yohimbine|"placebo first~Yohimbine: Yohimbine capsule"
11101691|NCT01593215|BG001|Baseline|Yohimbine First Then Yohimbine|Yohimbine first and then placebo
11101692|NCT01593215|BG002|Baseline|Total|Total of all reporting groups
11101693|NCT01593215|FG000|Participant Flow|Placebo First Then Yohimbine|Placebo first, then 2 weeks washout and then yohimbine
11101694|NCT01593215|FG001|Participant Flow|Yohimbine First Then Placebo|Yohimbine first, 2 weeks washout and then placebo
11101695|NCT01593215|OG000|Outcome|Placebo|"placebo~Yohimbine: Yohimbine capsule"
11101696|NCT01593215|OG001|Outcome|Yohimbine|"Yohimbine~Yohimbine: Yohimbine capsule"
11101697|NCT01593215|EG000|Reported Event|Placebo|"placebo~Yohimbine: Yohimbine capsule"
11101698|NCT01593215|EG001|Reported Event|Yohimbine|"Yohimbine~Yohimbine: Yohimbine capsule"
11101699|NCT01593592|BG000|Baseline|Lactobacillus Reuteri Group|The active group that will receive the standard triple therapy and Lactobacillus reuteri
11101700|NCT01593592|BG001|Baseline|Control Group|The control group that will receive the standard triple therapy and placebo
11101701|NCT01593592|BG002|Baseline|Total|Total of all reporting groups
11101702|NCT01593592|FG000|Participant Flow|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
11101703|NCT01593592|FG001|Participant Flow|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
11101704|NCT01593592|OG000|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
11101705|NCT01593592|OG001|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
11101706|NCT01593592|EG000|Reported Event|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
11101707|NCT01593592|EG001|Reported Event|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
11101708|NCT01593670|BG000|Baseline|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
11101709|NCT01593670|FG000|Participant Flow|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
11126452|NCT01733329|EG001|Reported Event|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
11101710|NCT01593670|OG000|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
11101711|NCT01593670|EG000|Reported Event|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
11101712|NCT01593696|BG000|Baseline|Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
11101713|NCT01593696|BG001|Baseline|Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
11101714|NCT01593696|BG002|Baseline|Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
11101715|NCT01593696|BG003|Baseline|Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|"Intensive lymphodepleting chemotherapy, in lieu of the standard lymphodepleting chemotherapy regimen, to decrease tumor burden in preparation for the administration of the Chimeric antigen receptor (CAR) T cells.~Anti-Cluster of Differentiation (CD)19- Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion."
11101716|NCT01593696|BG004|Baseline|Total|Total of all reporting groups
11101717|NCT01593696|FG000|Participant Flow|Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|"Lymphodepleting regimen of Fludarabine and Cyclophosphamide.~Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.~Follow-up through at least 28 days after CD19 CAR infusion."
11101718|NCT01593696|FG001|Participant Flow|Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)|"Lymphodepleting regimen of Fludarabine and Cyclophosphamide.~Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.~Follow-up through at least 28 days after CD19 CAR infusion."
11101719|NCT01593696|FG002|Participant Flow|Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|"Intensive lymphodepleting chemotherapy, in lieu of the standard lymphodepleting chemotherapy regimen, to decrease tumor burden in preparation for the administration of the Chimeric antigen receptor (CAR) T cells.~Anti-Cluster of Differentiation (CD)19- Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.~Follow-up through at least 28 days after CD19 CAR infusion."
11101720|NCT01593696|FG003|Participant Flow|Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|"Intensive lymphodepleting chemotherapy, in lieu of the standard lymphodepleting chemotherapy regimen, to decrease tumor burden in preparation for the administration of the Chimeric antigen receptor (CAR) T cells.~Anti-Cluster of Differentiation (CD)19- Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.~Follow-up through at least 28 days after CD19 CAR infusion."
11101721|NCT01593696|OG000|Outcome|Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
11101722|NCT01593696|OG001|Outcome|Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
11101723|NCT01593696|OG002|Outcome|Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
11101724|NCT01593696|OG003|Outcome|Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|"Intensive lymphodepleting chemotherapy, in lieu of the standard lymphodepleting chemotherapy regimen, to decrease tumor burden in preparation for the administration of the Chimeric antigen receptor (CAR) T cells.~Anti-Cluster of Differentiation (CD)19- Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion."
11101725|NCT01593696|EG000|Reported Event|Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
11101726|NCT01593696|EG001|Reported Event|Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
11101727|NCT01593696|EG002|Reported Event|Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|Lymphodepleting regimen of Fludarabine and Cyclophosphamide. Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion.
10846723|NCT00279305|BG002|Baseline|Total|Total of all reporting groups
11101728|NCT01593696|EG003|Reported Event|Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)|"Intensive lymphodepleting chemotherapy, in lieu of the standard lymphodepleting chemotherapy regimen, to decrease tumor burden in preparation for the administration of the Chimeric antigen receptor (CAR) T cells.~Anti-Cluster of Differentiation (CD)19- Chimeric antigen receptor (CAR): Cells extracted, followed by induction chemotherapy before CD19-CAR infusion."
11101729|NCT01593722|BG000|Baseline|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
11101730|NCT01593722|BG001|Baseline|SIngle Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
11101731|NCT01593722|BG002|Baseline|Total|Total of all reporting groups
11101732|NCT01593722|FG000|Participant Flow|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
11101733|NCT01593722|FG001|Participant Flow|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
11101734|NCT01593722|OG000|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
11101735|NCT01593722|OG001|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
11101736|NCT01593722|OG000|Outcome|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
11101737|NCT01593722|OG001|Outcome|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
11101738|NCT01593722|EG000|Reported Event|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
11101739|NCT01593722|EG001|Reported Event|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
11101740|NCT01593748|BG000|Baseline|Experimental|"Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal.~Gemcitabine and Pazopanib: Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Pazopanib 800 mg by oral tablet daily for a 21 day cycle."
11101741|NCT01593748|BG001|Baseline|Standard of Care|"Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1).~Gemcitabine and Docetaxel: Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle."
11101742|NCT01593748|BG002|Baseline|Total|Total of all reporting groups
11101743|NCT01593748|FG000|Participant Flow|Experimental|"Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal.~Gemcitabine and Pazopanib: Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Pazopanib 800 mg by oral tablet daily for a 21 day cycle."
11101744|NCT01593748|FG001|Participant Flow|Standard of Care|"Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1).~Gemcitabine and Docetaxel: Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle."
11101745|NCT01593748|OG000|Outcome|Experimental|"Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal.~Gemcitabine and Pazopanib: Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Pazopanib 800 mg by oral tablet daily for a 21 day cycle."
11101746|NCT01593748|OG001|Outcome|Standard of Care|"Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1).~Gemcitabine and Docetaxel: Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle."
11101747|NCT01593748|EG000|Reported Event|Experimental|"Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal.~Gemcitabine and Pazopanib: Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Pazopanib 800 mg by oral tablet daily for a 21 day cycle."
11101748|NCT01593748|EG001|Reported Event|Standard of Care|"Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1).~Gemcitabine and Docetaxel: Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle."
11101749|NCT01593787|BG000|Baseline|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
11101750|NCT01593787|BG001|Baseline|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
11101751|NCT01593787|BG002|Baseline|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
11101752|NCT01593787|BG003|Baseline|Total|Total of all reporting groups
11101753|NCT01593787|FG000|Participant Flow|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
11101754|NCT01593787|FG001|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
11101755|NCT01593787|FG002|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
11101756|NCT01593787|OG000|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
11101757|NCT01593787|OG001|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
11101758|NCT01593787|OG002|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
11101759|NCT01593787|OG003|Outcome|Total LCZ696|All participants who received LCZ696
11101760|NCT01593787|EG000|Reported Event|LCZ 100 mg|LCZ 100 mg
11101761|NCT01593787|EG001|Reported Event|LCZ 400 mg|LCZ 400 mg
11101762|NCT01593787|EG002|Reported Event|Total LCZ696|All participants who received LCZ696
11101763|NCT01593787|EG003|Reported Event|LCZ 200 mg|LCZ 200 mg
11101764|NCT01593917|BG000|Baseline|Subjects Previously Implanted With a Trifecta™ Valve|Subjects enrolled in this clinical study were implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study conducted to obtain FDA approval. Baseline data are from the pre-implant Baseline and Implant Visits in the Trifecta™ IDE Study.
11101765|NCT01593917|FG000|Participant Flow|Subjects Previously Implanted With a Trifecta™ Valve|Subjects enrolled in this clinical study received the Trifecta™ valve during the Trifecta™ IDE Study conducted to obtain FDA approval.
11101766|NCT01593917|OG000|Outcome|Subjects Previously Implanted With a Trifecta™ Valve|Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
11101767|NCT01593917|EG000|Reported Event|Subjects Previously Implanted With a Trifecta Valve|Subjects enrolled in this clinical study received the Trifecta valve during the investigational study that was conducted to obtain FDA approval. The Trifecta™ is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position.
11101768|NCT01594125|BG000|Baseline|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
11101769|NCT01594125|BG001|Baseline|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
11101770|NCT01594125|BG002|Baseline|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
11101771|NCT01594125|BG003|Baseline|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
11101772|NCT01594125|BG004|Baseline|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
11101773|NCT01594125|BG005|Baseline|Total|Total of all reporting groups
11101774|NCT01594125|FG000|Participant Flow|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
11101775|NCT01594125|FG001|Participant Flow|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
11101776|NCT01594125|FG002|Participant Flow|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
11101777|NCT01594125|FG003|Participant Flow|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
11101778|NCT01594125|FG004|Participant Flow|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
11101779|NCT01594125|OG000|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
11101780|NCT01594125|OG001|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
11101781|NCT01594125|OG002|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
11126453|NCT01733368|BG000|Baseline|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
10846724|NCT00279305|FG000|Participant Flow|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
11101782|NCT01594125|OG003|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
11101783|NCT01594125|OG004|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
11101784|NCT01594125|EG000|Reported Event|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
11101785|NCT01594125|EG001|Reported Event|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
11101786|NCT01594125|EG002|Reported Event|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
11101787|NCT01594125|EG003|Reported Event|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
11101788|NCT01594125|EG004|Reported Event|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
11101789|NCT01594281|BG000|Baseline|Ranibizumab Mono|"Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)~Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24"
11101790|NCT01594281|BG001|Baseline|PRP Mono|"Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures. If stability of morphological parameters could not be confirmed after 3 months, additional laser treatment was initiated.~Non-Interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24."
11101791|NCT01594281|BG002|Baseline|Ranibizumab+PRP|"Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed~Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24"
11101792|NCT01594281|BG003|Baseline|Total|Total of all reporting groups
11101793|NCT01594281|FG000|Participant Flow|Ranibizumab Mono|"Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)~Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24"
11101794|NCT01594281|FG001|Participant Flow|PRP Mono|"Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures. If stability of morphological parameters could not be confirmed after 3 months, additional laser treatment was initiated.~Non-Interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24."
11101795|NCT01594281|FG002|Participant Flow|Ranibizumab+PRP|"Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed~Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24"
11101796|NCT01594281|OG000|Outcome|Ranibizumab Mono|Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
11101797|NCT01594281|OG001|Outcome|PRP Mono|Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
11101798|NCT01594281|OG002|Outcome|Ranibizumab+PRP|Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
11101799|NCT01594281|EG000|Reported Event|Ranibizumab Mono Until Month 12|All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
11101800|NCT01594281|EG001|Reported Event|PRP Mono Until Month 12|All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
11101801|NCT01594281|EG002|Reported Event|Ranibizumab+PRP Until Month 12|All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
11101802|NCT01594281|EG003|Reported Event|Ranibizumab Mono Month 12 to 24|Non-interventional follow up phase
11101803|NCT01594281|EG004|Reported Event|PRP Mono Month 12 to 24|Non-interventional follow up phase
11101804|NCT01594281|EG005|Reported Event|Ranibizumab+PRP Month 12 to 24|Non-interventional follow up phase
11101805|NCT01594294|BG000|Baseline|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
11101806|NCT01594294|BG001|Baseline|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
11101807|NCT01594294|BG002|Baseline|Total|Total of all reporting groups
11101808|NCT01594294|FG000|Participant Flow|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
11101809|NCT01594294|FG001|Participant Flow|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
11101810|NCT01594294|OG000|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
11101811|NCT01594294|OG001|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
11101812|NCT01594294|EG000|Reported Event|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
11101813|NCT01594294|EG001|Reported Event|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
11101814|NCT01594333|BG000|Baseline|Methotrexate|Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
11101815|NCT01594333|BG001|Baseline|Placebo|Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
11101816|NCT01594333|BG002|Baseline|Total|Total of all reporting groups
11101817|NCT01594333|FG000|Participant Flow|Methotrexate|Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
11101818|NCT01594333|FG001|Participant Flow|Placebo|Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
11101819|NCT01594333|OG000|Outcome|Methotrexate|Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
11101820|NCT01594333|OG001|Outcome|Placebo|Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
11101821|NCT01594333|EG000|Reported Event|Methotrexate|Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
11101822|NCT01594333|EG001|Reported Event|Placebo|Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
11101823|NCT01594385|BG000|Baseline|Seprafilm|"The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in approximately 1:1 ratio.~Seprafilm: Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:~Two Seprafilm pieces between the liver and the anterior abdominal wall~Four pieces over the exposed bowel surfaces anteriorly~Two slightly staggered pieces of Seprafilm in each colic gutter~Two pieces in the pelvic area.~If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair."
11101824|NCT01594385|BG001|Baseline|No Seprafilm|Patients in this group will not receive Seprafilm during re-operations. Otherwise, their surgical management will be identical to the Seprafilm Group.
11101825|NCT01594385|BG002|Baseline|Total|Total of all reporting groups
11101826|NCT01594385|FG000|Participant Flow|Seprafilm Group|Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.
11101827|NCT01594385|FG001|Participant Flow|No Seprafilm Group|Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
11101828|NCT01594385|OG000|Outcome|Seprafilm|Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25
11101829|NCT01594385|OG001|Outcome|No Seprafilm|Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
11101830|NCT01594385|OG000|Outcome|Wound Sizes: Seprafilm|"Wound size characteristics (estimated area = Width x Length in centimeters squared) for patients who received Seprafilm"
11101831|NCT01594385|OG001|Outcome|Wound Sizes: No Seprafilm|"Wound size characteristics (estimated area = Width x Length in centimeters squared) for patients who did not receive Seprafilm"
11101832|NCT01594385|OG000|Outcome|Seprafilm|The treatment group will receive Seprafilm.
11101833|NCT01594385|OG001|Outcome|No Seprafilm|This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
11101834|NCT01594385|EG000|Reported Event|Seprafilm Group|Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.
11101835|NCT01594385|EG001|Reported Event|No Seprafilm Group|Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
11101836|NCT01594411|BG000|Baseline|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
11101837|NCT01594411|FG000|Participant Flow|All Subjects With Corus CAD|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment and being tested with Corus CAD is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
11101838|NCT01594411|OG000|Outcome|No Tests/Treatment|Physician decision for no additional tests or cardiac treatment after receiving patients' GES
11101839|NCT01594411|OG001|Outcome|Medical Therapy|Physician decision for lifestyle changes or medical therapy after receiving patients' GES
11101840|NCT01594411|OG002|Outcome|Stress Test|Physician decision for stress testing (with or without imaging) or computed tomography/coronary angiography after receiving patients' GES
11101841|NCT01594411|OG003|Outcome|Invasive Angiography|Physician decision for invasive coronary angiography after receiving patients' GES
11101842|NCT01594411|EG000|Reported Event|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
11101843|NCT01594424|BG000|Baseline|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
11101844|NCT01594424|FG000|Participant Flow|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
11101845|NCT01594424|OG000|Outcome|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
11101846|NCT01594424|EG000|Reported Event|IVIG + Tocilizumab|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
11101847|NCT01594476|BG000|Baseline|Levonorgestrel IUS Insertion at 3 Weeks|"IUD placement at 3 weeks after delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101848|NCT01594476|BG001|Baseline|Levonorgestrel IUS Insertion at 6 Weeks|"IUD placement at 6 weeks after delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101849|NCT01594476|BG002|Baseline|Total|Total of all reporting groups
11101850|NCT01594476|FG000|Participant Flow|IUD Insertion at 3 Weeks|"IUD placement at 3 weeks after delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS or Copper T intrauterine device"
11101851|NCT01594476|FG001|Participant Flow|IUD Insertion at 6 Weeks|"IUD placement at 6 weeks after delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS or Copper T intrauterine device"
11101852|NCT01594476|OG000|Outcome|IUD Insertion at 3 Weeks|"IUD placement at 3 weeks after delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101853|NCT01594476|OG001|Outcome|IUD Insertion at 6 Weeks|"IUD placement at 6 weeks after delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101854|NCT01594476|OG000|Outcome|18-24 Days After Vaginal Delivery|"IUD placement at 18-24 days after vaginal delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101855|NCT01594476|OG001|Outcome|39-45 Days After Vaginal Delivery|"IUD placement at 39-45 days after vaginal delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101856|NCT01594476|OG002|Outcome|18-24 Days After Cesarean Delivery|"IUD placement at 18-24 days after cesarean delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101857|NCT01594476|OG003|Outcome|39-45 Days After Cesarean Delivery|"IUD placement at 39-45 days after cesarean delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101858|NCT01594476|EG000|Reported Event|IUD Insertion at 3 Weeks|"IUD placement at 3 weeks after delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101859|NCT01594476|EG001|Reported Event|IUD Insertion at 6 Weeks|"IUD placement at 6 weeks after delivery.~Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device"
11101860|NCT01594515|BG000|Baseline|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101861|NCT01594515|BG001|Baseline|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101862|NCT01594515|BG002|Baseline|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101863|NCT01594515|BG003|Baseline|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101864|NCT01594515|BG004|Baseline|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101865|NCT01594515|BG005|Baseline|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101866|NCT01594515|BG006|Baseline|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101867|NCT01594515|BG007|Baseline|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101868|NCT01594515|BG008|Baseline|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101869|NCT01594515|BG009|Baseline|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
11101870|NCT01594515|BG010|Baseline|Total|Total of all reporting groups
11101871|NCT01594515|FG000|Participant Flow|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101872|NCT01594515|FG001|Participant Flow|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101873|NCT01594515|FG002|Participant Flow|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101874|NCT01594515|FG003|Participant Flow|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101875|NCT01594515|FG004|Participant Flow|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101876|NCT01594515|FG005|Participant Flow|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101877|NCT01594515|FG006|Participant Flow|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101878|NCT01594515|FG007|Participant Flow|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101879|NCT01594515|FG008|Participant Flow|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101880|NCT01594515|FG009|Participant Flow|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
11101881|NCT01594515|OG000|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101882|NCT01594515|OG001|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101883|NCT01594515|OG002|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101884|NCT01594515|OG003|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101885|NCT01594515|OG004|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101886|NCT01594515|OG005|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101887|NCT01594515|OG006|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101888|NCT01594515|OG007|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101889|NCT01594515|OG008|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101890|NCT01594515|OG009|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
11101891|NCT01594515|EG000|Reported Event|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
11101892|NCT01594515|EG001|Reported Event|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101893|NCT01594515|EG002|Reported Event|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101894|NCT01594515|EG003|Reported Event|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101895|NCT01594515|EG004|Reported Event|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
10846725|NCT00279305|FG001|Participant Flow|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
11101896|NCT01594515|EG005|Reported Event|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101897|NCT01594515|EG006|Reported Event|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101898|NCT01594515|EG007|Reported Event|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101899|NCT01594515|EG008|Reported Event|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101900|NCT01594515|EG009|Reported Event|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
11101901|NCT01594528|BG000|Baseline|Major Depression|subjects with major depression
11101902|NCT01594528|BG001|Baseline|Schizophrenia|subjects with schizophrenia
11101903|NCT01594528|BG002|Baseline|Control|subjects without psychiatric disorders
11101904|NCT01594528|BG003|Baseline|Total|Total of all reporting groups
11101905|NCT01594528|FG000|Participant Flow|Control|"behavior during experimental pain tests for control subjects~pain tests: pain induction with pressure application or ischemia on the arm"
11101906|NCT01594528|FG001|Participant Flow|SChizophrenia|"behavior during experimental pain tests for subjects with schizophrenia~pain tests: pain induction with pressure application or ischemia on the arm"
11101907|NCT01594528|FG002|Participant Flow|Major Depression|behavior during experimental pain tests for subjects with major depression pain tests: pain induction with pressure application or ischemia on the arm
11101908|NCT01594528|OG000|Outcome|Group of Subjects Presenting Schizophrenia SC|"subjects with diagnosis of schizophrenia according to the DSM-IV-TR and experimentating pain tests: pain induction with pressure application or ischemia on the arm.~and observation of the behavior as defined with facial, corporal and vocal indicators during experimental pain tests"
11101909|NCT01594528|OG001|Outcome|Group of Subjects Presenting Major Depression MD|"subjects presenting a diagnosis of major depression according to the DSM-IV-TR and experimentating pain tests: pain induction with pressure application or ischemia on the arm.~and observation of the behavior as defined with facial, corporal and vocal indicators during experimental pain tests"
11101910|NCT01594528|OG002|Outcome|Group of Subjects Without Psychiatric Troubles C|"control subjects without any psychiatric disorder and experimentating the same pain tests as the other groups: pain induction with pressure application or ischemia on the arm.~and observation of the behavior as defined with facial, corporal and vocal indicators during experimental pain tests"
11101911|NCT01594528|EG000|Reported Event|Diagnosis|"diagnosis according to the DSM-IV-TR : major depression and schizophrenia, or control.~pain tests: pain induction with pressure application or ischemia on the arm"
11101912|NCT01594749|BG000|Baseline|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
11101913|NCT01594749|BG001|Baseline|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
11101914|NCT01594749|BG002|Baseline|Total|Total of all reporting groups
11101915|NCT01594749|FG000|Participant Flow|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
11101916|NCT01594749|FG001|Participant Flow|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
11101917|NCT01594749|OG000|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
11101918|NCT01594749|OG001|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
11126454|NCT01733368|FG000|Participant Flow|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
11101919|NCT01594749|EG000|Reported Event|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
11101920|NCT01594749|EG001|Reported Event|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
11101921|NCT01594762|BG000|Baseline|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment~Standard wound care: 28-day trial period"
11101922|NCT01594762|BG001|Baseline|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment~Standard wound care: 28-day trial period"
11101923|NCT01594762|BG002|Baseline|Total|Total of all reporting groups
11101924|NCT01594762|FG000|Participant Flow|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
11101925|NCT01594762|FG001|Participant Flow|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
11101926|NCT01594762|OG000|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
11101927|NCT01594762|OG001|Outcome|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
11101928|NCT01594762|EG000|Reported Event|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
11101929|NCT01594762|EG001|Reported Event|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
11101930|NCT01594827|BG000|Baseline|Inhaled Vancomycin and Oral Antibiotics|In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
11101931|NCT01594827|BG001|Baseline|Inhaled Placebo (Sterile Water) and Oral Antibiotics|In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
11101932|NCT01594827|BG002|Baseline|Total|Total of all reporting groups
11101933|NCT01594827|FG000|Participant Flow|Inhaled Vancomycin and Oral Antibiotics|In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol.
11101934|NCT01594827|FG001|Participant Flow|Inhaled Placebo (Sterile Water) and Oral Antibiotics|In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol.
11101935|NCT01594827|OG000|Outcome|Inhaled Vancomycin and Oral Antibiotics|In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
11101936|NCT01594827|OG001|Outcome|Inhaled Placebo (Sterile Water) and Oral Antibiotics|In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
11101937|NCT01594827|OG000|Outcome|Inhaled Vancomycin and Oral Antibiotics|In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol.
11126455|NCT01733368|OG000|Outcome|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
10846726|NCT00279305|OG000|Outcome|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
11101938|NCT01594827|OG001|Outcome|Inhaled Placebo (Sterile Water) and Oral Antibiotics|In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol.
11101939|NCT01594827|EG000|Reported Event|Inhaled Vancomycin and Oral Antibiotics|In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
11101940|NCT01594827|EG001|Reported Event|Inhaled Placebo (Sterile Water) and Oral Antibiotics|In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
11101941|NCT01594853|BG000|Baseline|Female Carriers|"Female carriers will participate in an exercise paradigm.~exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week."
11101942|NCT01594853|BG001|Baseline|Healthy Controls|"Healthy age and gender matched individuals will participate in an exercise paradigm.~exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week."
11101943|NCT01594853|BG002|Baseline|Total|Total of all reporting groups
11101944|NCT01594853|FG000|Participant Flow|Female Carriers|"Female carriers will participate in an exercise paradigm.~exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week."
11101945|NCT01594853|FG001|Participant Flow|Healthy Controls|"Healthy age and gender matched individuals will participate in an exercise paradigm.~exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week."
11101946|NCT01594853|OG000|Outcome|Female Carriers|"Female carriers will participate in an exercise paradigm.~exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week."
11101947|NCT01594853|OG001|Outcome|Healthy Controls|"Healthy age and gender matched individuals will participate in an exercise paradigm.~exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week."
11101948|NCT01594853|EG000|Reported Event|Female Carriers|"Female carriers will participate in an exercise paradigm.~exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week."
11101949|NCT01594853|EG001|Reported Event|Healthy Controls|"Healthy age and gender matched individuals will participate in an exercise paradigm.~exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week."
11101950|NCT01594931|BG000|Baseline|Group A: Pyronaridine/Artesunate (6:2 mg/kg)|"Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101951|NCT01594931|BG001|Baseline|Group B: Pyronaridine/Artesunate (9:3 mg/kg)|"Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101952|NCT01594931|BG002|Baseline|Group C: Pyronaridine/Artesunate (12:4 mg/kg)|"Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101953|NCT01594931|BG003|Baseline|Total|Total of all reporting groups
11101954|NCT01594931|FG000|Participant Flow|Group A: Pyronaridine/Artesunate (6:2 mg/kg)|"Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101955|NCT01594931|FG001|Participant Flow|Group B: Pyronaridine/Artesunate (9:3 mg/kg)|"Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101956|NCT01594931|FG002|Participant Flow|Group C: Pyronaridine/Artesunate (12:4 mg/kg)|"Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101957|NCT01594931|OG000|Outcome|Group A: Pyronaridine/Artesunate (6:2 mg/kg)|"Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101958|NCT01594931|OG001|Outcome|Group B: Pyronaridine/Artesunate (9:3 mg/kg)|"Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101959|NCT01594931|OG002|Outcome|Group C: Pyronaridine/Artesunate (12:4 mg/kg)|"Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101960|NCT01594931|EG000|Reported Event|Group A: Pyronaridine/Artesunate (6:2 mg/kg)|"Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
10846727|NCT00279305|OG001|Outcome|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
10846728|NCT00279305|EG000|Reported Event|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
11101961|NCT01594931|EG001|Reported Event|Group B: Pyronaridine/Artesunate (9:3 mg/kg)|"Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101962|NCT01594931|EG002|Reported Event|Group C: Pyronaridine/Artesunate (12:4 mg/kg)|"Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg~Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1"
11101963|NCT01594970|BG000|Baseline|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
11101964|NCT01594970|BG001|Baseline|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
11101965|NCT01594970|BG002|Baseline|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
11101966|NCT01594970|BG003|Baseline|Total|Total of all reporting groups
11101967|NCT01594970|FG000|Participant Flow|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
11101968|NCT01594970|FG001|Participant Flow|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
11101969|NCT01594970|FG002|Participant Flow|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
11101970|NCT01594970|OG000|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
11101971|NCT01594970|OG001|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
11101972|NCT01594970|OG002|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
11101973|NCT01594970|EG000|Reported Event|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
11101974|NCT01594970|EG001|Reported Event|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
11101975|NCT01594970|EG002|Reported Event|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
11101976|NCT01595282|BG000|Baseline|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
11101977|NCT01595282|BG001|Baseline|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
11101978|NCT01595282|BG002|Baseline|Total|Total of all reporting groups
11101979|NCT01595282|FG000|Participant Flow|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
11101980|NCT01595282|FG001|Participant Flow|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
11101981|NCT01595282|OG000|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
11101982|NCT01595282|OG001|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
11101983|NCT01595282|EG000|Reported Event|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
11126456|NCT01733368|OG000|Outcome|6-Month CRT Responder|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a responder at 6 months of follow-up.
11101984|NCT01595282|EG001|Reported Event|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
11101985|NCT01595386|BG000|Baseline|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
11101986|NCT01595386|BG001|Baseline|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
11101987|NCT01595386|BG002|Baseline|Total|Total of all reporting groups
11101988|NCT01595386|FG000|Participant Flow|Normal Saline|"The subjects will receive a bolus after successful completion of bypass and the post-pump adrenocorticotrophic hormone (ACTH) stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
11101989|NCT01595386|FG001|Participant Flow|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of cardiopulmonary bypass (CPB) and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
11101990|NCT01595386|OG000|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
11101991|NCT01595386|OG001|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
11101992|NCT01595386|EG000|Reported Event|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
11101993|NCT01595386|EG001|Reported Event|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
11101994|NCT01595438|BG000|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
11101995|NCT01595438|BG001|Baseline|Doripenem|Doripenem treatment group
11101996|NCT01595438|BG002|Baseline|Total|Total of all reporting groups
11101997|NCT01595438|FG000|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
11101998|NCT01595438|FG001|Participant Flow|Doripenem|Doripenem treatment group
11101999|NCT01595438|OG000|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
11102000|NCT01595438|OG001|Outcome|Doripenem|Doripenem treatment group
11102001|NCT01595438|EG000|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
11102002|NCT01595438|EG001|Reported Event|Doripenem|Doripenem treatment group
11102003|NCT01595516|BG000|Baseline|Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11102004|NCT01595516|BG001|Baseline|Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11102005|NCT01595516|BG002|Baseline|Placebo|Placebo: Gelatin capsule to be taken by mouth once per day for 12 weeks
11102006|NCT01595516|BG003|Baseline|Total|Total of all reporting groups
11102007|NCT01595516|FG000|Participant Flow|Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11102008|NCT01595516|FG001|Participant Flow|Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11102009|NCT01595516|FG002|Participant Flow|Placebo|Placebo: Gelatin capsule to be taken by mouth once per day for 12 weeks
11102010|NCT01595516|OG000|Outcome|Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11102011|NCT01595516|OG001|Outcome|Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11102012|NCT01595516|OG002|Outcome|Placebo|Placebo: Gelatin capsule to be taken by mouth once per day for 12 weeks
10846729|NCT00279305|EG001|Reported Event|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
11102013|NCT01595516|OG000|Outcome|Before Nebivolol|Before randomization to nebivolol
11102014|NCT01595516|OG001|Outcome|After Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11102015|NCT01595516|OG002|Outcome|Before Metoprolol|Before randomization to metoprolol
11102016|NCT01595516|OG003|Outcome|After Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11102017|NCT01595516|OG004|Outcome|Before Placebo|Before randomization to placebo
11102018|NCT01595516|OG005|Outcome|After Placebo|Placebo: Gelatin capsule to be taken by mouth once per day for 12 weeks
11102019|NCT01595516|OG000|Outcome|Before Nebivolol: Saline|Net t-PA antigen release in response to BDK before 12 weeks of nebivolol therapy.
11102020|NCT01595516|OG001|Outcome|Before Nebivolol: Vitamin C|Net t-PA antigen release in response to BDK+C before 12 weeks of nebivolol therapy.
11102021|NCT01595516|OG002|Outcome|After Nebivolol: Saline|Net t-PA antigen release in response to BDK after 12 weeks of nebivolol therapy.
11102022|NCT01595516|OG003|Outcome|After Nebivolol: Vitamin C|Net t-PA antigen release in response to BDK+C after 12 weeks of nebivolol therapy.
11102023|NCT01595516|OG000|Outcome|Before Metoprolol: Saline|Net t-PA antigen release in response to BDK before 12 weeks of nebivolol therapy.
11102024|NCT01595516|OG001|Outcome|Before Metoprolol: Vitamin C|Net t-PA antigen release in response to BDK+C before 12 weeks of nebivolol therapy.
11102025|NCT01595516|OG002|Outcome|After Metoprolol: Saline|Net t-PA antigen release in response to BDK after 12 weeks of nebivolol therapy.
11102026|NCT01595516|OG003|Outcome|After Metoprolol: Vitamin C|Net t-PA antigen release in response to BDK+C after 12 weeks of nebivolol therapy.
11102027|NCT01595516|EG000|Reported Event|Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11102028|NCT01595516|EG001|Reported Event|Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11102029|NCT01595516|EG002|Reported Event|Placebo|Placebo: Gelatin capsule to be taken by mouth once per day for 12 weeks
11102030|NCT01595529|BG000|Baseline|Standard Course Treatment|"5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)~Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.~Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses~Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day."
11102031|NCT01595529|BG001|Baseline|Short Course Treatment|"5 days of placebo treatment to match physician-initiated therapy~Placebo: Placebo to match the other four active treatments"
11102032|NCT01595529|BG002|Baseline|Total|Total of all reporting groups
11102033|NCT01595529|FG000|Participant Flow|Standard Course Treatment|"5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)~Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.~Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses~Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day."
11102034|NCT01595529|FG001|Participant Flow|Short Course Treatment|"5 days of placebo treatment to match physician-initiated therapy~Placebo: Placebo to match the other four active treatments"
11102035|NCT01595529|OG000|Outcome|Standard Course Treatment|"5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)~Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.~Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses~Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day."
11102036|NCT01595529|OG001|Outcome|Short Course Treatment|"5 days of placebo treatment to match physician-initiated therapy~Placebo: Placebo to match the other four active treatments"
11102037|NCT01595529|EG000|Reported Event|Standard Course Treatment|"5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)~Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.~Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses~Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day."
11102038|NCT01595529|EG001|Reported Event|Short Course Treatment|"5 days of placebo treatment to match physician-initiated therapy~Placebo: Placebo to match the other four active treatments"
11102039|NCT01595646|BG000|Baseline|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
11102040|NCT01595646|BG001|Baseline|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
11102041|NCT01595646|BG002|Baseline|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
11102042|NCT01595646|BG003|Baseline|Total|Total of all reporting groups
11102043|NCT01595646|FG000|Participant Flow|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
11102044|NCT01595646|FG001|Participant Flow|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
11102045|NCT01595646|FG002|Participant Flow|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
11102046|NCT01595646|OG000|Outcome|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
11102047|NCT01595646|OG001|Outcome|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
11102048|NCT01595646|OG002|Outcome|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
11102049|NCT01595646|OG000|Outcome|Saline|"Saline placebo taken twice per day via intranasal route.~Saline: Saline, administered intranasally twice per day for a 16 week duration"
11102050|NCT01595646|OG001|Outcome|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day) via intranasal route~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
11102051|NCT01595646|OG002|Outcome|Insulin|"20IU Insulin, administered twice per day (40IU total per day) via intranasal route~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
11102052|NCT01595646|EG000|Reported Event|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
11102053|NCT01595646|EG001|Reported Event|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
11102054|NCT01595646|EG002|Reported Event|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
11102055|NCT01595854|BG000|Baseline|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
11102056|NCT01595854|BG001|Baseline|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
11102057|NCT01595854|BG002|Baseline|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
11102058|NCT01595854|BG003|Baseline|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
11102059|NCT01595854|BG004|Baseline|Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3|"A randomised two-period cross-over trial, the two treatments administered were~A single dose of dabigatran etexilate 75 mg~Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered with a single dose of 75 mg Dabigatran etexilate on days 1 and 4.~Between treatment periods there was a washout period of at least 4 days."
11102060|NCT01595854|BG005|Baseline|Total|Total of all reporting groups
11102061|NCT01595854|FG000|Participant Flow|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
11102062|NCT01595854|FG001|Participant Flow|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
11102063|NCT01595854|FG002|Participant Flow|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
11102064|NCT01595854|FG003|Participant Flow|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
11102065|NCT01595854|FG004|Participant Flow|Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3|"A randomised, two-period, cross-over trial, the two treatments administered were~A single dose of dabigatran etexilate 75 mg~Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.~Between treatment periods there was a washout period of at least 4 days."
11102066|NCT01595854|OG000|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
11102067|NCT01595854|OG001|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
11102068|NCT01595854|OG002|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (MD) ticagrelor.
11102069|NCT01595854|OG002|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (LD) ticagrelor.
11102070|NCT01595854|OG000|Outcome|Dabigatran 220 mg - Part 1|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
11102071|NCT01595854|OG001|Outcome|Ticagrelor 180 mg - Part 1|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
11102072|NCT01595854|OG002|Outcome|Dabigatran 220 mg - Part 2|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
11102073|NCT01595854|OG003|Outcome|Ticagrelor 180 mg - Part 2|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test.
11102074|NCT01595854|OG004|Outcome|Dabigatran 75 mg - Part 3|A single dose of Dabigatran etexilate 75 mg
11102075|NCT01595854|OG005|Outcome|Dabigatran + Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
11102076|NCT01595854|EG000|Reported Event|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
11102077|NCT01595854|EG001|Reported Event|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
11102078|NCT01595854|EG002|Reported Event|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
11102079|NCT01595854|EG003|Reported Event|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
11102080|NCT01595854|EG004|Reported Event|Dabi 75 mg - Part 3|A single dose of dabigatran etexilate (Dabi) 75 mg
11102081|NCT01595854|EG005|Reported Event|Multiple Dose Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
11102082|NCT01596062|BG000|Baseline|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
11102083|NCT01596062|BG001|Baseline|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
11102084|NCT01596062|BG002|Baseline|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
11102085|NCT01596062|BG003|Baseline|Total|Total of all reporting groups
11102086|NCT01596062|FG000|Participant Flow|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
11102087|NCT01596062|FG001|Participant Flow|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
11102088|NCT01596062|FG002|Participant Flow|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
11102089|NCT01596062|OG000|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
11102090|NCT01596062|OG001|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
10879523|NCT00458341|FG000|Participant Flow|Ataluren 4, 4, and 8 mg/kg, Then Ataluren 10, 10, and 20 mg/kg|During Cycle 1, participants received ataluren at 4 milligrams (mg/kg) in the morning, 4 mg/kg at midday, and 8 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. Then, the participants crossed over to the other ataluren dose regimen (ataluren 10, 10, and 20 mg/kg) for Cycle 2.
11102091|NCT01596062|OG002|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
11102092|NCT01596062|EG000|Reported Event|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
11102093|NCT01596062|EG001|Reported Event|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
11102094|NCT01596062|EG002|Reported Event|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
11102095|NCT01596088|BG000|Baseline|Dexrazoxane|
11102096|NCT01596088|FG000|Participant Flow|Dexrazoxane|
11102097|NCT01596088|OG000|Outcome|Dexrazoxane|
11102098|NCT01596088|EG000|Reported Event|Dexrazoxane|
11102099|NCT01596127|BG000|Baseline|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
11102100|NCT01596127|FG000|Participant Flow|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
11102101|NCT01596127|OG000|Outcome|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
11102102|NCT01596127|EG000|Reported Event|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
11102103|NCT01596231|BG000|Baseline|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
11102104|NCT01596231|BG001|Baseline|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
11102105|NCT01596231|BG002|Baseline|Total|Total of all reporting groups
11102106|NCT01596231|FG000|Participant Flow|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
11102107|NCT01596231|FG001|Participant Flow|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
11102108|NCT01596231|OG000|Outcome|Placebo|Placebo did not alter alcohol consumption compared to baseline.
11102109|NCT01596231|OG001|Outcome|Kudzu|Kudzu extract treatment significantly reduced the number of beers opened and total amounts (weight and volume) consumed. Latency and time to consume a beer was not significantly altered, and there was no difference in the number of sips taken to drink a beer.
11102110|NCT01596231|EG000|Reported Event|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
11102111|NCT01596231|EG001|Reported Event|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
11102112|NCT01596283|BG000|Baseline|Goal-directed Therapy|
11102113|NCT01596283|BG001|Baseline|Standard Perioperative Resuscitation|
11102114|NCT01596283|BG002|Baseline|Total|Total of all reporting groups
11102115|NCT01596283|FG000|Participant Flow|Goal-directed Therapy (GDT) After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
11102116|NCT01596283|FG001|Participant Flow|Standard Perioperative Resuscitation After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
11102117|NCT01596283|OG000|Outcome|Standard Fluid Management|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Standard fluid management: The patient will receive standard fluid management"
11102118|NCT01596283|OG001|Outcome|Goal Directed Fluid Therapy|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system."
11102119|NCT01596283|OG000|Outcome|Goal-directed Therapy (GDT) After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
11102120|NCT01596283|OG001|Outcome|Standard Perioperative Resuscitation After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
11102121|NCT01596283|EG000|Reported Event|Standard Fluid Management|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Standard fluid management: The patient will receive standard fluid management"
11102122|NCT01596283|EG001|Reported Event|Goal Directed Fluid Therapy|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system."
11102123|NCT01596335|BG000|Baseline|TA-650|TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.
11102124|NCT01596335|BG001|Baseline|Polyethylene Glycol-treated Human Immunoglobulin (VGIH)|Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
11102125|NCT01596335|BG002|Baseline|Total|Total of all reporting groups
11102126|NCT01596335|FG000|Participant Flow|TA-650|TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.
11102127|NCT01596335|FG001|Participant Flow|Polyethylene Glycol-treated Human Immunoglobulin (VGIH)|Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
11102128|NCT01596335|OG000|Outcome|TA-650|TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.
11102129|NCT01596335|OG001|Outcome|Polyethylene Glycol-treated Human Immunoglobulin (VGIH)|Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
11102130|NCT01596335|EG000|Reported Event|TA-650|TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.
11102131|NCT01596335|EG001|Reported Event|Polyethylene Glycol-treated Human Immunoglobulin (VGIH)|Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
11102132|NCT01596504|BG000|Baseline|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
11102133|NCT01596504|BG001|Baseline|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
11102134|NCT01596504|BG002|Baseline|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
11102135|NCT01596504|BG003|Baseline|Total|Total of all reporting groups
11102136|NCT01596504|FG000|Participant Flow|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
11102137|NCT01596504|FG001|Participant Flow|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
11102138|NCT01596504|FG002|Participant Flow|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
11102139|NCT01596504|OG000|Outcome|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
11102140|NCT01596504|OG001|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
11102141|NCT01596504|OG002|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
11102142|NCT01596504|OG000|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
11102143|NCT01596504|EG000|Reported Event|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
11102144|NCT01596504|EG001|Reported Event|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
11102145|NCT01596504|EG002|Reported Event|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
11102146|NCT01596582|BG000|Baseline|Standard Care|Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
11102147|NCT01596582|BG001|Baseline|Risk Assessment|"Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.~Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never)."
11102148|NCT01596582|BG002|Baseline|Total|Total of all reporting groups
11102149|NCT01596582|FG000|Participant Flow|Standard Care|Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
11102150|NCT01596582|FG001|Participant Flow|Risk Assessment|"Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) and the ACNI risk assessment tool just prior to a scheduled office visit with their provider.~Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never)."
11102151|NCT01596582|OG000|Outcome|Standard Care|Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
11102152|NCT01596582|OG001|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
11102153|NCT01596582|OG000|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
11102154|NCT01596582|OG001|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
11102155|NCT01596582|OG000|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
11102156|NCT01596582|OG001|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
11102157|NCT01596582|OG000|Outcome|Pretest|Provider responses to a 3-item pretest administered prior the commencement of the study.
11102158|NCT01596582|OG001|Outcome|Posttest|Provider responses to the same 3-item posttest administered after completion of study enrollment. Provider responses to a 3-item pretest administered prior the commencement of the study.
11102159|NCT01596582|OG000|Outcome|Standard Care|Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
11102160|NCT01596582|EG000|Reported Event|Standard Care|Subjects randomized to the experimental arm will review the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
11102161|NCT01596582|EG001|Reported Event|Risk Assessment|Subjects randomized to the experimental arm will complete the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
11102162|NCT01596595|BG000|Baseline|RELIANCE 4-SITE|Baseline characteristics include enrolled subjects who were implanted (1779) or attempted for implant (11) of an ENDOTAK® RELIANCE 4-SITE lead and Boston Scientific pulse generator compatible with the RELIANCE 4-SITE family of cardiac leads. Intent subjects (30) are not included in the baseline characteristics.
11102163|NCT01596595|FG000|Participant Flow|RELIANCE 4-SITE|There were 1820 patients who were consented for participation in the LSS of 4-SITE Study. Of the 1820 participants enrolled 1779 were implanted and followed for the study. There were 11 subjects who were attempted for implant but did not receive a study devices and 30 subjects who were determined to be intent subjects (did not undergo surgery) and were withdrawn from the study.
11102164|NCT01596595|OG000|Outcome|RELIANCE 4-SITE|There were 1820 patients who were consented for participation in the LSS of 4-SITE Study. Of the 1820 participants enrolled 1779 were implanted and followed for the study. There were 11 subjects who were attempted for implant but did not receive a study devices and 30 subjects who were determined to be intent subjects (did not undergo surgery) and were withdrawn from the study. These 41 subjects are not included in the endpoint analysis. The endpoint was analyzed using intent to treat analysis.
11102165|NCT01596595|EG000|Reported Event|RELIANCE 4-SITE|All-Cause Mortality and Adverse Events are reported for all enrolled subjects (N=1820).
11102166|NCT01596699|BG000|Baseline|Stratum A: Patients With Non-Malignancies|"Alemtuzumab: 0.5 mg/kg (max 15 mg or max 6 mg), IV, Day -12 to Day -10 pre-HCT~Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102167|NCT01596699|BG001|Baseline|Stratum B: Patients With Myeloid Malignancies|"Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102168|NCT01596699|BG002|Baseline|Total|Total of all reporting groups
11102169|NCT01596699|FG000|Participant Flow|Stratum A: Patients With Non-Malignancies|"Alemtuzumab: 0.5 mg/kg (max 15 mg or max 6 mg), IV, Day -12 to Day -10 pre-Hematopoietic cell transplantation (HCT)~Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102170|NCT01596699|FG001|Participant Flow|Stratum B: Patients With Myeloid Malignancies|"Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102171|NCT01596699|OG000|Outcome|Stratum A: Patients With Non-Malignancies|"Alemtuzumab: 0.5 mg/kg (max 15 mg or max 6 mg), IV, Day -12 to Day -10 pre-HCT~Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102172|NCT01596699|OG001|Outcome|Stratum B: Patients With Myeloid Malignancies|"Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102173|NCT01596699|OG000|Outcome|Stratum B: Patients With Myeloid Malignancies|"Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102174|NCT01596699|EG000|Reported Event|Stratum A: Patients With Non-Malignancies|"Alemtuzumab: 0.5 mg/kg (max 15 mg or max 6 mg), IV, Day -12 to Day -10 pre-HCT~Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102175|NCT01596699|EG001|Reported Event|Stratum B: Patients With Myeloid Malignancies|"Busulfan: 0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT~Fludarabine: 40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT~Clofarabine: 10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT"
11102176|NCT01596751|BG000|Baseline|Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102177|NCT01596751|BG001|Baseline|Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
11102178|NCT01596751|BG002|Baseline|Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102179|NCT01596751|BG003|Baseline|Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102180|NCT01596751|BG004|Baseline|Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102181|NCT01596751|BG005|Baseline|Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102182|NCT01596751|BG006|Baseline|Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin|Treatment began with a 7 day Lead-in Phase, consisting of 1000 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 1000 mg/day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
11102183|NCT01596751|BG007|Baseline|Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin|Treatment began with a 7 day Lead-in Phase, consisting of 800 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 800 mg/day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
11102184|NCT01596751|BG008|Baseline|Total|Total of all reporting groups
11102185|NCT01596751|FG000|Participant Flow|Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
10846730|NCT00279500|BG000|Baseline|Treatment Arm|Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells.
11102186|NCT01596751|FG001|Participant Flow|Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
11102187|NCT01596751|FG002|Participant Flow|Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102188|NCT01596751|FG003|Participant Flow|Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102189|NCT01596751|FG004|Participant Flow|Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102190|NCT01596751|FG005|Participant Flow|Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102191|NCT01596751|FG006|Participant Flow|Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin|Treatment began with a 7 day Lead-in Phase, consisting of 1000 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 1000 mg/day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
11102192|NCT01596751|FG007|Participant Flow|Phase II/2: 800 mg/Day PLX3397 Lead In+Combined With Eribulin|Treatment began with a 7 day Lead-in Phase, consisting of 800 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 800 mg/day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
11102193|NCT01596751|OG000|Outcome|Phase Ib: Eribulin in Combination With PLX3397|"Phase Ib:~21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously, day 1 and 8~Cohort 1: 600 mg/day~Cohort 2: 800 mg/day~Cohort 3: 1000 mg/day"
11102194|NCT01596751|OG000|Outcome|Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102195|NCT01596751|OG001|Outcome|Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
11102196|NCT01596751|OG002|Outcome|Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102197|NCT01596751|OG003|Outcome|Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102198|NCT01596751|OG004|Outcome|Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102199|NCT01596751|OG005|Outcome|Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin|Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
11102200|NCT01596751|OG000|Outcome|Phase II: PLX3397 Combined With Eribulin|Treatment began with a 7 day Lead-in Phase, consisting of 800 mg or 1000 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 800 mg or 1000mg /day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
11102201|NCT01596751|EG000|Reported Event|Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin|"Treatments are given in 21 day cycles. For each cycle, treatment includes:~PLX3397 at a dose of 600 mg/day taken by mouth in the form of 100-200 mg gelcaps~Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.~PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 600mg, oral administration~Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days"
11102202|NCT01596751|EG001|Reported Event|Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin|"Treatments are given in 21 day cycles. For each cycle, treatment includes:~PLX3397 at a dose of 400 mg/day taken by mouth in the form of 100-200 mg gelcaps~Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.~PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 400mg, oral administration~Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days"
11102203|NCT01596751|EG002|Reported Event|Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin|"Treatments are given in 21 day cycles. For each cycle, treatment includes:~PLX3397 at a dose of 600 mg/day taken by mouth in the form of 100-200 mg gelcaps~Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.~PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 600 mg, oral administration~Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days"
11102204|NCT01596751|EG003|Reported Event|Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin|"Treatments are given in 21 day cycles. For each cycle, treatment includes:~PLX3397 at a dose of 800 mg/day taken by mouth in the form of 100-200 mg gelcaps~Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8~PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration~Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days"
11102205|NCT01596751|EG004|Reported Event|Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin|"Treatments are given in 21 day cycles. For each cycle, treatment includes:~PLX3397 at a dose of 800 mg/day taken by mouth in the form of 100-200 mg gelcaps~Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8~PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration~Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days"
11102206|NCT01596751|EG005|Reported Event|Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin|"Treatments are given in 21 day cycles. For each cycle, treatment includes:~PLX3397 at a dose of 1000 mg/day taken by mouth in the form of 100-200 mg gelcaps~Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8~PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 1000 mg, oral administration~Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days"
11102207|NCT01596751|EG006|Reported Event|Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin|"Treatment begins with a 7 day Lead-in phase of PLX3397 alone, followed by 21 day cycles of PLX3397 in combination with eribulin.~Lead-in phase treatment:~PLX3397 at a dose of 1000 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest.~Treatment given in each 21 day cycle:~PLX3397 at a dose of 1000 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest, repeated weekly~Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8~PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 1000 mg, oral administration~Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days"
11102208|NCT01596751|EG007|Reported Event|Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin|"Treatment begins with a 7 day Lead-in phase of PLX3397 alone, followed by 21 day cycles of PLX3397 in combination with eribulin.~Lead-in phase treatment:~PLX3397 at a dose of 800 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest.~Treatment given in each 21 day cycle:~PLX3397 at a dose of 800 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest, repeated weekly~Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8~PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration~Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days"
11102209|NCT01596842|BG000|Baseline|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
11102210|NCT01596842|BG001|Baseline|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
11102211|NCT01596842|BG002|Baseline|Total|Total of all reporting groups
11102212|NCT01596842|FG000|Participant Flow|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
11102213|NCT01596842|FG001|Participant Flow|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
11102214|NCT01596842|OG000|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
11102215|NCT01596842|OG001|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
11102216|NCT01596842|EG000|Reported Event|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
11102217|NCT01596842|EG001|Reported Event|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
11126457|NCT01733368|OG001|Outcome|6-Month CRT Non-Responder|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a non-responder at 6 months of follow-up.
11126458|NCT01733368|EG000|Reported Event|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
11126459|NCT01733407|BG000|Baseline|Sugar Pill|"Placebo arm~placebo: 400mg/kg/d divided TID for year 1 only."
11126460|NCT01733407|BG001|Baseline|L-serine|"amino acid supplementation with L-serine~L-serine: 400mg/kg/d L-serine or placebo divided TID for year 1, then crossover of placebo arm so that all patients on 400mg/kg/d L-serine divided TID for year 2."
11126461|NCT01733407|BG002|Baseline|Total|Total of all reporting groups
11126462|NCT01733407|FG000|Participant Flow|Sugar Pill|"Placebo arm~placebo: 400mg/kg/d divided TID for year 1 only."
11126463|NCT01733407|FG001|Participant Flow|L-serine|"amino acid supplementation with L-serine~L-serine: 400mg/kg/d L-serine or placebo divided TID for year 1, then crossover of placebo arm so that all patients on 400mg/kg/d L-serine divided TID for year 2."
11126464|NCT01733407|OG000|Outcome|Sugar Pill|"Placebo arm~placebo: 400mg/kg/d divided TID for year 1 only."
11102218|NCT01596972|BG000|Baseline|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
11102219|NCT01596972|BG001|Baseline|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
11102220|NCT01596972|BG002|Baseline|Total|Total of all reporting groups
11102221|NCT01596972|FG000|Participant Flow|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
11102222|NCT01596972|FG001|Participant Flow|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
11102223|NCT01596972|OG000|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
11102224|NCT01596972|OG001|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
11102225|NCT01596972|EG000|Reported Event|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
11102226|NCT01596972|EG001|Reported Event|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
11102227|NCT01597050|BG000|Baseline|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
11102228|NCT01597050|BG001|Baseline|Placebo|"Placebo, bid~Placebo: Placebo, bid"
11102229|NCT01597050|BG002|Baseline|Total|Total of all reporting groups
11102230|NCT01597050|FG000|Participant Flow|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
11102231|NCT01597050|FG001|Participant Flow|Placebo|"Placebo, bid~Placebo: Placebo, bid"
11102232|NCT01597050|OG000|Outcome|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
11102233|NCT01597050|OG001|Outcome|Placebo|"Placebo, bid~Placebo: Placebo, bid"
11102234|NCT01597050|EG000|Reported Event|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
11102235|NCT01597050|EG001|Reported Event|Placebo|"Placebo, bid~Placebo: Placebo, bid"
11102236|NCT01597128|BG000|Baseline|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
11102237|NCT01597128|BG001|Baseline|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
11102238|NCT01597128|BG002|Baseline|Total|Total of all reporting groups
11102239|NCT01597128|FG000|Participant Flow|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
11102240|NCT01597128|FG001|Participant Flow|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
11102241|NCT01597128|OG000|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
11102242|NCT01597128|OG001|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
11102243|NCT01597128|EG000|Reported Event|Flex HD|"Mesh Type~Flex HD: Flex HD mesh for hernia repair"
11102244|NCT01597128|EG001|Reported Event|Strattice|"Use of a second mesh type~Strattice: Strattice mash for hernia repair"
11102245|NCT01597141|BG000|Baseline|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
11102246|NCT01597141|BG001|Baseline|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
11102247|NCT01597141|BG002|Baseline|Total|Total of all reporting groups
11003964|NCT01075048|OG000|Outcome|Phase 2: Placebo+Cetuximab+Irinotecan|Participants received placebo twice daily (BID) with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/ m^2 intravenous infusion over 120 minutes, then over 60 minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003965|NCT01075048|OG001|Outcome|Phase 2: ARQ 197+Cetuximab+Irinotecan|Participants received ARQ197 (recommended Phase 2 dose of 720 mg) daily with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and Irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003966|NCT01075048|OG000|Outcome|Phase 1: ARQ 197+Cetuximab+Irinotecan|Participants received an oral dose of ARQ197 capsules twice daily (BID) with a meal, in escalating doses of 120 milligram (mg), 240 mg, and 360 mg to 3 separate cohorts on Day 1 of Cycle 1 and Cycle 2. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed by 60 minutes with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003967|NCT01075048|OG001|Outcome|Phase 2: Placebo+Cetuximab+Irinotecan|Participants received placebo twice daily (BID) with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/ m^2 intravenous infusion over 120 minutes, then over 60 minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003968|NCT01075048|OG002|Outcome|Phase 2: ARQ 197+Cetuximab+Irinotecan|Participants received ARQ197 (recommended Phase 2 dose of 720 mg) daily with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and Irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003969|NCT01075048|OG003|Outcome|All ARQ 197|All participants who received ARQ 197 treatment.
11003970|NCT01075048|EG000|Reported Event|Phase 1: ARQ 197+Cetuximab+Irinotecan|Participants received an oral dose of ARQ197 capsules twice daily (BID) with a meal, in escalating doses of 120 milligram (mg), 240 mg, and 360 mg to 3 separate cohorts on Day 1 of Cycle 1 and Cycle 2. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed by 60 minutes with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003971|NCT01075048|EG001|Reported Event|Phase 2: Placebo+Cetuximab+Irinotecan|Participants received placebo twice daily (BID) with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/ m^2 intravenous infusion over 120 minutes, then over 60 minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003972|NCT01075048|EG002|Reported Event|Phase 2: ARQ 197+Cetuximab+Irinotecan|Participants received ARQ197 (recommended Phase 2 dose of 720 mg) daily with cetuximab and irinotecan until disease progression, unacceptable toxicity or other discontinuation. Cetuximab 500 mg/m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles followed 60 minutes later with irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Cetuximab and Irinotecan are administered on Day 1 and Day 15 of each 28 day cycle.
11003973|NCT01075074|BG000|Baseline|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
11003974|NCT01075074|BG001|Baseline|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
11003975|NCT01075074|BG002|Baseline|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
11003976|NCT01075074|BG003|Baseline|Total|Total of all reporting groups
11003977|NCT01075074|FG000|Participant Flow|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
11003978|NCT01075074|FG001|Participant Flow|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
11003979|NCT01075074|FG002|Participant Flow|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
11003980|NCT01075074|OG000|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
11003981|NCT01075074|OG001|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
11003982|NCT01075074|OG002|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
11003983|NCT01075074|OG001|Outcome|Normal Saline|The normal saline group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
11003984|NCT01075074|OG000|Outcome|Ropivacaine 0.5%|Ropivacaine 0.5% group will receive a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
11003985|NCT01075074|OG001|Outcome|Normal Saline|Normal saline group will receive a bilateral transversus abdominis plane block 15 cc of sterile normal saline.
11003986|NCT01075074|OG002|Outcome|Ropivacaine 0.25%|Ropivicaine 0.25% group will receive a bilateral transversus abdominis plane block using 15 cc of 0.25% ropivacaine on each side
11003987|NCT01075074|EG000|Reported Event|Ropivacaine 0.5%|Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine
11003988|NCT01075074|EG001|Reported Event|Normal Saline|Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.
11003989|NCT01075074|EG002|Reported Event|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25%
11003990|NCT01075087|BG000|Baseline|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
11003991|NCT01075087|BG001|Baseline|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
11003992|NCT01075087|BG002|Baseline|Total|Total of all reporting groups
11003993|NCT01075087|FG000|Participant Flow|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
11003994|NCT01075087|FG001|Participant Flow|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
11003995|NCT01075087|OG000|Outcome|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
11003996|NCT01075087|OG001|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
11003997|NCT01075087|EG000|Reported Event|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
11003998|NCT01075087|EG001|Reported Event|Active Comparator|(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
11003999|NCT01075100|BG000|Baseline|Triple Negative|ER-/PR-/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004000|NCT01075100|BG001|Baseline|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004001|NCT01075100|BG002|Baseline|Total|Total of all reporting groups
11004002|NCT01075100|FG000|Participant Flow|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004003|NCT01075100|FG001|Participant Flow|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004004|NCT01075100|OG000|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004005|NCT01075100|OG001|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004006|NCT01075100|OG001|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004007|NCT01075100|OG000|Outcome|Triple Negative|ER-/PR-/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004008|NCT01075100|EG000|Reported Event|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004009|NCT01075100|EG001|Reported Event|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
11004010|NCT01075152|BG000|Baseline|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis.
11004011|NCT01075152|BG001|Baseline|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week)
11004012|NCT01075152|BG002|Baseline|Total|Total of all reporting groups
11004013|NCT01075152|FG000|Participant Flow|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal diagnosis
11004014|NCT01075152|FG001|Participant Flow|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/1 week)
11004015|NCT01075152|OG000|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
11004016|NCT01075152|OG001|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week).
11004017|NCT01075152|OG001|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
11004018|NCT01075152|OG000|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis]
11004019|NCT01075152|EG000|Reported Event|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
11004020|NCT01075152|EG001|Reported Event|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
11004021|NCT01075178|BG000|Baseline|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
11004022|NCT01075178|BG001|Baseline|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
11004023|NCT01075178|BG002|Baseline|Total|Total of all reporting groups
11004024|NCT01075178|FG000|Participant Flow|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
11004025|NCT01075178|FG001|Participant Flow|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
11004026|NCT01075178|OG000|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
11004027|NCT01075178|OG001|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
11004028|NCT01075178|EG000|Reported Event|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
11004029|NCT01075178|EG001|Reported Event|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
11102248|NCT01597141|FG000|Participant Flow|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
11102249|NCT01597141|FG001|Participant Flow|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
11102250|NCT01597141|OG000|Outcome|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
11102251|NCT01597141|OG001|Outcome|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
11102252|NCT01597141|OG000|Outcome|Family-aided Assertive Community Treatment|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
11102253|NCT01597141|OG001|Outcome|Enhanced Standard Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
11102254|NCT01597141|EG000|Reported Event|Family-aided Assertive Community Treatment|The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
11102255|NCT01597141|EG001|Reported Event|Enhanced Standard Treatment|In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
11102256|NCT01597193|BG000|Baseline|Dose Escalation: Enzalutamide 80 mg|Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102257|NCT01597193|BG001|Baseline|Dose Escalation: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102258|NCT01597193|BG002|Baseline|Dose Expansion: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102259|NCT01597193|BG003|Baseline|Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102260|NCT01597193|BG004|Baseline|Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102261|NCT01597193|BG005|Baseline|Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102262|NCT01597193|BG006|Baseline|Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102263|NCT01597193|BG007|Baseline|Total|Total of all reporting groups
11126465|NCT01733407|OG001|Outcome|L-serine|"amino acid supplementation with L-serine~L-serine: 400mg/kg/d L-serine or placebo divided TID for year 1, then crossover of placebo arm so that all patients on 400mg/kg/d L-serine divided TID for year 2."
11126466|NCT01733407|EG000|Reported Event|Sugar Pill|"Placebo arm~placebo: 400mg/kg/d divided TID for year 1 only."
11102264|NCT01597193|FG000|Participant Flow|Dose Escalation: Enzalutamide 80 mg|Participants received enzalutamide 80 milligram (mg) (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102265|NCT01597193|FG001|Participant Flow|Dose Escalation: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102266|NCT01597193|FG002|Participant Flow|Dose Expansion: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102267|NCT01597193|FG003|Participant Flow|Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102268|NCT01597193|FG004|Participant Flow|Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102269|NCT01597193|FG005|Participant Flow|Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102270|NCT01597193|FG006|Participant Flow|Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102271|NCT01597193|OG000|Outcome|Dose Escalation: Enzalutamide 80 mg|Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102272|NCT01597193|OG001|Outcome|Dose Escalation: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102273|NCT01597193|OG002|Outcome|Dose Expansion: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102274|NCT01597193|OG003|Outcome|Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102275|NCT01597193|OG004|Outcome|Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102276|NCT01597193|OG005|Outcome|Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102277|NCT01597193|OG006|Outcome|Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102278|NCT01597193|OG000|Outcome|Dose Expansion: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102279|NCT01597193|OG001|Outcome|Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102280|NCT01597193|OG002|Outcome|Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102281|NCT01597193|OG003|Outcome|Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102282|NCT01597193|OG004|Outcome|Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102283|NCT01597193|EG000|Reported Event|Dose Escalation: Enzalutamide 80 mg|Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102284|NCT01597193|EG001|Reported Event|Dose Escalation: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102285|NCT01597193|EG002|Reported Event|Dose Expansion: Enzalutamide 160 mg|Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102286|NCT01597193|EG003|Reported Event|Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102287|NCT01597193|EG004|Reported Event|Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102288|NCT01597193|EG005|Reported Event|Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11126467|NCT01733407|EG001|Reported Event|L-serine|"amino acid supplementation with L-serine~L-serine: 400mg/kg/d L-serine or placebo divided TID for year 1, then crossover of placebo arm so that all patients on 400mg/kg/d L-serine divided TID for year 2."
11126468|NCT01733472|BG000|Baseline|RA-arm|"RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg~placebo"
11102289|NCT01597193|EG006|Reported Event|Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg|Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
11102290|NCT01597245|BG000|Baseline|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
11102291|NCT01597245|BG001|Baseline|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
11102292|NCT01597245|BG002|Baseline|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
11102293|NCT01597245|BG003|Baseline|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
11102294|NCT01597245|BG004|Baseline|Total|Total of all reporting groups
11102295|NCT01597245|FG000|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
11102296|NCT01597245|FG001|Participant Flow|50 mg Etanercept (ETN) - Induction Period|50 milligrams (mg) ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
11102297|NCT01597245|FG002|Participant Flow|Ixe Q4W - Induction Period|160 mg ixekizumab (ixe) was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W:Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
11102298|NCT01597245|FG003|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12
11102299|NCT01597245|FG004|Participant Flow|Ixe/Placebo- Maintenance Period Primary Population (Pop)|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11102300|NCT01597245|FG005|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102301|NCT01597245|FG006|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at Weeks 16, 20, 28, 32, 40, 44, 52, and 56.
11102302|NCT01597245|FG007|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders (resp) and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11102303|NCT01597245|FG008|Participant Flow|Placebo NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders (NonResp) were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102304|NCT01597245|FG009|Participant Flow|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11102305|NCT01597245|FG010|Participant Flow|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102306|NCT01597245|FG011|Participant Flow|Ixe Q4W NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102307|NCT01597245|FG012|Participant Flow|Ixe Q2W NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102308|NCT01597245|FG013|Participant Flow|Placebo Long-Term Extension (LTE)|Participants who received placebo at the start of long-term extension period (Week 60) and could be switched to ixe. Data while participants were on placebo were included.
11102309|NCT01597245|FG014|Participant Flow|Ixe Long-Term Extension|Participants who received 80 mg ixe in all dosing regimens at the start of the long-term extension period from Week 60 to Week 264.
10846731|NCT00279500|FG000|Participant Flow|Argus 16 Retinal Stimulation System|Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells.
11004030|NCT01075191|BG000|Baseline|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
11004031|NCT01075191|FG000|Participant Flow|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
11004032|NCT01075191|OG000|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
11004033|NCT01075191|EG000|Reported Event|HIV-infected Participants|"HIV-infected patients taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily).~Safety data presents all enrolled participants, including 5 protocol violations."
11004034|NCT01075204|BG000|Baseline|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
11004035|NCT01075204|FG000|Participant Flow|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
11004036|NCT01075204|OG000|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
11004037|NCT01075204|EG000|Reported Event|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
11004038|NCT01075217|BG000|Baseline|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004039|NCT01075217|BG001|Baseline|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004040|NCT01075217|BG002|Baseline|Total|Total of all reporting groups
11004041|NCT01075217|FG000|Participant Flow|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004042|NCT01075217|FG001|Participant Flow|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004043|NCT01075217|OG000|Outcome|Isovue 250 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004044|NCT01075217|OG001|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004045|NCT01075217|OG002|Outcome|Visipaque 270 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004046|NCT01075217|OG003|Outcome|Visipaque 270 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004047|NCT01075217|OG000|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004048|NCT01075217|OG001|Outcome|Visipaque 270 VAS Score Immedicately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004049|NCT01075217|OG000|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004050|NCT01075217|OG001|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004051|NCT01075217|OG000|Outcome|Isovue 250 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004052|NCT01075217|OG001|Outcome|Visipaque 270 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004053|NCT01075217|EG000|Reported Event|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004054|NCT01075217|EG001|Reported Event|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
11004055|NCT01075243|BG000|Baseline|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
11004056|NCT01075243|BG001|Baseline|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
11004057|NCT01075243|BG002|Baseline|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
11004058|NCT01075243|BG003|Baseline|Total|Total of all reporting groups
11004059|NCT01075243|FG000|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 milliliter (mL) of water through oral route.
11004060|NCT01075243|FG001|Participant Flow|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
11004061|NCT01075243|FG002|Participant Flow|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
11004062|NCT01075243|OG000|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
11004063|NCT01075243|OG001|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
11004064|NCT01075243|OG002|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
11004065|NCT01075243|OG000|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
11004066|NCT01075243|OG000|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
11004067|NCT01075243|EG000|Reported Event|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
11004068|NCT01075243|EG001|Reported Event|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
11004069|NCT01075243|EG002|Reported Event|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
11004070|NCT01075256|BG000|Baseline|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004071|NCT01075256|BG001|Baseline|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004072|NCT01075256|BG002|Baseline|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
11004073|NCT01075256|BG003|Baseline|Total|Total of all reporting groups
11004074|NCT01075256|FG000|Participant Flow|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004075|NCT01075256|FG001|Participant Flow|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004076|NCT01075256|FG002|Participant Flow|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
11004077|NCT01075256|OG000|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004078|NCT01075256|OG001|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004079|NCT01075256|OG002|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
11004080|NCT01075256|OG000|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004081|NCT01075256|OG001|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11102310|NCT01597245|FG015|Participant Flow|Total Ixe Long-Term Extension|Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in long-term extension (LTE) period.
11102311|NCT01597245|FG016|Participant Flow|Placebo Post-Treatment Follow-Up|Participants who received PBO immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102312|NCT01597245|FG017|Participant Flow|ETN Post-Treatment Follow-Up|Participants who received ETN immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102313|NCT01597245|FG018|Participant Flow|Ixe Q12W Post-Treatment Follow-Up|Participants who received 80 mg ixe 1 SC injection Q12W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102314|NCT01597245|FG019|Participant Flow|Ixe Q4W Post-Treatment Follow-Up|Participants who received 80 mg ixe 1 SC injection Q4W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102315|NCT01597245|FG020|Participant Flow|Ixe Q2W Post-Treatment Follow-Up|Participants who received 80 mg ixe 1 SC injection Q2W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102316|NCT01597245|OG000|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
11102317|NCT01597245|OG001|Outcome|50 mg Etanercept (ETN) - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
11102318|NCT01597245|OG002|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
11102319|NCT01597245|OG003|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
11102320|NCT01597245|OG001|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
11102321|NCT01597245|OG002|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
11102322|NCT01597245|OG000|Outcome|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11102323|NCT01597245|OG001|Outcome|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at Weeks 16, 20, 28, 32, 40, 44, 52, and 56.
11102324|NCT01597245|OG002|Outcome|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102325|NCT01597245|EG000|Reported Event|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
11102326|NCT01597245|EG001|Reported Event|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
11102327|NCT01597245|EG002|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W): (Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
11102328|NCT01597245|EG003|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
11102329|NCT01597245|EG004|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11102330|NCT01597245|EG005|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102331|NCT01597245|EG006|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at Weeks 16, 20, 28, 32, 40, 44, 52, and 56.
11102332|NCT01597245|EG007|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11102333|NCT01597245|EG008|Reported Event|Placebo NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102334|NCT01597245|EG009|Reported Event|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11102335|NCT01597245|EG010|Reported Event|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102336|NCT01597245|EG011|Reported Event|Ixe Q4W NonResp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102337|NCT01597245|EG012|Reported Event|Ixe Q2W NonResp/Ixe Q4W Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102338|NCT01597245|EG013|Reported Event|Ixe Q4W Maintenance Period Relapsed Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11102339|NCT01597245|EG014|Reported Event|Placebo Long-Term Extension|Participants who received placebo at the start of long-term extension period (Week 60) and could be switched to ixe. Data while participants were on placebo were included.
11102340|NCT01597245|EG015|Reported Event|Ixe Long-Term Extension|Participants who received 80 mg ixe in all dosing regimens at the start of the long-term extension period from Week 60 to Week 264.
11102341|NCT01597245|EG016|Reported Event|Total Ixe Long-Term Extension|Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in long-term extension (LTE) period.
11102342|NCT01597245|EG017|Reported Event|Placebo Post-Treatment Follow-Up|Participants who received PBO immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102343|NCT01597245|EG018|Reported Event|ETN Post-Treatment Follow-Up|Participants who received ETN immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102344|NCT01597245|EG019|Reported Event|Ixe Q2W Post-Treatment Follow-Up|Participants who received 80 mg ixe 1 SC injection Q2W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102345|NCT01597245|EG020|Reported Event|Ixe Q4W Post-Treatment Follow-Up|Participants who received 80 mg ixe 1 SC injection Q4W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102346|NCT01597245|EG021|Reported Event|Ixe Q12W Post-Treatment Follow-Up|Participants who received 80 mg ixe 1 SC injection Q12W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11102347|NCT01597258|BG000|Baseline|XALKORI Capsules (Crizotinib)|Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.
11102348|NCT01597258|FG000|Participant Flow|XALKORI Capsules (Crizotinib)|Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.
11102349|NCT01597258|OG000|Outcome|XALKORI Capsules (Crizotinib)|Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.
11102350|NCT01597258|EG000|Reported Event|XALKORI Capsules (Crizotinib)|Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.
11102351|NCT01597375|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Prasugrel or Placebo oral tablets and who successfully completed both treatment assignments.
11102352|NCT01597375|FG000|Participant Flow|Placebo Then Prasugrel|"Subjects with AERD first received placebo oral tablet for 4 weeks prior to their aspirin challenge/desensitization. After aspirin challenge/desensitization subjects were discharged to home to washout the study drug from the first treatment phase. At the end of the 2-week washout period, subjects crossed over to the alternate treatment for 4 weeks of Prasugrel oral tablets [ (5 mg (for patients <60kg) or 10mg (> 60kg) daily, following a 60mg loading dose)] and returned for the second aspirin challenge.~Because no period effect was observed, data obtained from all subjects while on placebo from either visit 2 or 3 were combined."
11102353|NCT01597375|FG001|Participant Flow|Prasugrel Then Placebo|"Subjects with AERD first received prasugrel oral tablets [ (5 mg (for patients <60kg) or 10mg (> 60kg) daily, following a 60mg loading dose)] prior to their aspirin challenge/desensitization. After aspirin challenge/desensitization subjects were discharged to home to washout the study drug from the first treatment phase. At the end of the 2-week washout period, subjects crossed over to the alternate treatment for 4 weeks of Placebo oral tablet.~Because no period effect was observed, data obtained from all subjects while on Prasugrel from either visit 2 or 3 were combined."
11102354|NCT01597375|OG000|Outcome|Placebo|Subjects with AERD who received placebo oral tablets either the first or last 4 weeks of the study.
11102355|NCT01597375|OG001|Outcome|Prasugrel|Subjects with AERD who received prasugrel oral tablets either the first or last 4 weeks of the study.
11102356|NCT01597375|OG000|Outcome|Subjects With AERD Completing 8 Weeks of Aspirin Treatment|Subjects with AERD who underwent Aspirin desensitization and 8 weeks of Aspirin treatment ( 650 mg of Aspirin twice daily )
11102357|NCT01597375|EG000|Reported Event|Placebo|Subjects with AERD who received placebo oral tablets either the first or last 4 weeks of the study.
11102358|NCT01597375|EG001|Reported Event|Prasugrel|Subjects with AERD who received prasugrel oral tablets either the first or last 4 weeks of the study.
11102359|NCT01597440|BG000|Baseline|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
11102360|NCT01597440|BG001|Baseline|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
11102361|NCT01597440|BG002|Baseline|Total|Total of all reporting groups
11102362|NCT01597440|FG000|Participant Flow|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
11102363|NCT01597440|FG001|Participant Flow|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
11102364|NCT01597440|OG000|Outcome|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
11102365|NCT01597440|OG001|Outcome|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
11102366|NCT01597440|OG000|Outcome|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG)~The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
11102367|NCT01597440|OG001|Outcome|Placebo|"Standard of Care Therapy~Standard of Care: Standard of Care"
11102368|NCT01597440|EG000|Reported Event|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
11102369|NCT01597440|EG001|Reported Event|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
11102370|NCT01597479|BG000|Baseline|dPNBs Group|dPNBs on radial and median nerves at the elbow in postoperative period, before discharge
11102371|NCT01597479|BG001|Baseline|Non dPNBs Group|Non intervention in postoperative period
11102372|NCT01597479|BG002|Baseline|Total|Total of all reporting groups
11102373|NCT01597479|FG000|Participant Flow|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"In dPNBs group, we practice distal peripheral nerves blocks guided by ultrasound and neurostimulator.~Levobupivacaine: In dPNBs group, we practice ultrasound guided distal peripheral nerve blocks on radial and median nerves using low volume and low concentration of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve).~We performed dPNBs in the postoperative period. Deffered dPNBs under the influence of axillary block didn't cause patient disconfort. We considered the technique safety due to ultrasound guidance."
11102374|NCT01597479|FG001|Participant Flow|No Intervention (no dPNBs Group)|In patients of no dPNBs group didn't performed any intervention after surgery.
11102375|NCT01597479|OG000|Outcome|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"We practiced ultrasound guided dPNBs on radial and median nerves, after surgery, before discharge.~Distal median nerve block was performed at the elbow, in the internal bicipital channel.~Distal radial nerve block was performed at approximately the junction of the middle and distal thirds of the arm.~We use 5ml per nerve of levobupivacaine 0,125% for target nerve blocks."
11102376|NCT01597479|OG001|Outcome|Non Distal Peripheral Nerve Blocks (Non dPNBs Group)|Patients in non dPNBs didn't received any intervention in the postoperatively period.
11102377|NCT01597479|OG000|Outcome|dPNBs Group|we practiced ultrasound guided dPNBs on radial and median nerves using a long acting and low concentration local anesthetic (0.125% levobupivacaine, 5 ml per nerve).
11102378|NCT01597479|OG001|Outcome|Non dPNBs Group|In this group any intervention was done.
11102379|NCT01597479|EG000|Reported Event|Distal Peripheral Nerve Block Group|Any patient undergoing ultrasound guided distal peripheral nerve block reported any complication.
11004082|NCT01075256|OG002|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
11004083|NCT01075256|OG002|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate (NovaMin) free placebo toothpaste. All study treatments were fluoride free.
11004084|NCT01075256|OG002|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
11004085|NCT01075256|EG000|Reported Event|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004086|NCT01075256|EG001|Reported Event|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
11004087|NCT01075256|EG002|Reported Event|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
11004088|NCT01075282|BG000|Baseline|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004089|NCT01075282|BG001|Baseline|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004090|NCT01075282|BG002|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004091|NCT01075282|BG003|Baseline|Total|Total of all reporting groups
11004092|NCT01075282|FG000|Participant Flow|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004093|NCT01075282|FG001|Participant Flow|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004094|NCT01075282|FG002|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004095|NCT01075282|OG000|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004096|NCT01075282|OG001|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004097|NCT01075282|OG002|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004098|NCT01075282|OG000|Outcome|LY2189265 1.5 mg and 0.75 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004099|NCT01075282|EG000|Reported Event|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004100|NCT01075282|EG001|Reported Event|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004101|NCT01075282|EG002|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
11004102|NCT01075321|BG000|Baseline|All Patients (Everolimus and Lenalidomide)|Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004103|NCT01075321|FG000|Participant Flow|Phase I: Dose Level -1|Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004104|NCT01075321|FG001|Participant Flow|Phase I: Dose Level 0|Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004105|NCT01075321|FG002|Participant Flow|Phase I: Dose Level 1|Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004106|NCT01075321|FG003|Participant Flow|Phase II: Dose Level 0|Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004107|NCT01075321|OG000|Outcome|Phase I: Dose Level -1|Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004108|NCT01075321|OG001|Outcome|Phase I: Dose Level 0|Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11102380|NCT01597492|BG000|Baseline|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
11102381|NCT01597492|BG001|Baseline|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
11102382|NCT01597492|BG002|Baseline|Total|Total of all reporting groups
11102383|NCT01597492|FG000|Participant Flow|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
11102384|NCT01597492|FG001|Participant Flow|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
11102385|NCT01597492|OG000|Outcome|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
11102386|NCT01597492|OG001|Outcome|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
11102387|NCT01597492|EG000|Reported Event|Belimumab Plus Early Vaccination|Belimumab plus Early Vaccination
11102388|NCT01597492|EG001|Reported Event|Belimumab Plus Late Vaccination|Belimumab plus Late Vaccination
11102389|NCT01597505|BG000|Baseline|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
11102390|NCT01597505|BG001|Baseline|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
11102391|NCT01597505|BG002|Baseline|Total|Total of all reporting groups
11102392|NCT01597505|FG000|Participant Flow|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
11102393|NCT01597505|FG001|Participant Flow|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
11102394|NCT01597505|OG000|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
11102395|NCT01597505|OG001|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
11102396|NCT01597505|OG000|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
11102397|NCT01597505|EG000|Reported Event|Surotomycin|250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 for 10 days
11102398|NCT01597505|EG001|Reported Event|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
11102399|NCT01597557|BG000|Baseline|Magnesium Sulfate|"Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure~Magnesium Sulfate: 2 grams intravenous drip over 30 minutes"
11102400|NCT01597557|BG001|Baseline|Placebo|"Patients in this arm receive normal saline drip intravenously before the cardioversion procedure~Placebo: Normal Saline 50 ml intravenous drip over 30 minutes"
11102401|NCT01597557|BG002|Baseline|Total|Total of all reporting groups
11102402|NCT01597557|FG000|Participant Flow|Magnesium Sulfate|"Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure~Magnesium Sulfate: 2 grams intravenous drip over 30 minutes"
11102403|NCT01597557|FG001|Participant Flow|Placebo|"Patients in this arm receive normal saline drip intravenously before the cardioversion procedure~Placebo: Normal Saline 50 ml intravenous drip over 30 minutes"
11102404|NCT01597557|OG000|Outcome|Magnesium Sulfate|"Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure~Magnesium Sulfate: 2 grams intravenous drip over 30 minutes"
11102405|NCT01597557|OG001|Outcome|Placebo|"Patients in this arm receive normal saline drip intravenously before the cardioversion procedure~Placebo: Normal Saline 50 ml intravenous drip over 30 minutes"
11102406|NCT01597557|EG000|Reported Event|Magnesium Sulfate|"Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure~Magnesium Sulfate: 2 grams intravenous drip over 30 minutes"
11102407|NCT01597557|EG001|Reported Event|Placebo|"Patients in this arm receive normal saline drip intravenously before the cardioversion procedure~Placebo: Normal Saline 50 ml intravenous drip over 30 minutes"
11102408|NCT01597596|BG000|Baseline|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
11102409|NCT01597596|BG001|Baseline|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
11102410|NCT01597596|BG002|Baseline|Total|Total of all reporting groups
11102411|NCT01597596|FG000|Participant Flow|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg intravenous (IV) infusion every other week (QOW) for 52 weeks.
11102412|NCT01597596|FG001|Participant Flow|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
11102413|NCT01597596|OG000|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
11102414|NCT01597596|OG001|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
11102415|NCT01597596|EG000|Reported Event|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
11102416|NCT01597596|EG001|Reported Event|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
11102417|NCT01597622|BG000|Baseline|Open-label Belimumab 10 mg/kg|Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
11102418|NCT01597622|FG000|Participant Flow|Open-label Belimumab 10 mg/kg|Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator.
11102419|NCT01597622|OG000|Outcome|Open-label Belimumab 10 mg/kg|Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
11102420|NCT01597622|EG000|Reported Event|Open-label Belimumab 10 mg/kg|Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
11102421|NCT01597635|BG000|Baseline|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 mg/kg, 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
11102422|NCT01597635|BG001|Baseline|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
11102423|NCT01597635|BG002|Baseline|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
11102424|NCT01597635|BG003|Baseline|Total|Total of all reporting groups
11102425|NCT01597635|FG000|Participant Flow|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kilograms [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
11102426|NCT01597635|FG001|Participant Flow|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) twice daily (BID) as a slow infusion over 3-5 minutes for 3 days.
11102427|NCT01597635|FG002|Participant Flow|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
11102428|NCT01597635|OG000|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
11102429|NCT01597635|OG001|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
11102430|NCT01597635|OG000|Outcome|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
11102431|NCT01597635|OG000|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
11102432|NCT01597635|EG000|Reported Event|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 mg/kg, 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
11102433|NCT01597635|EG001|Reported Event|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
11102434|NCT01597635|EG002|Reported Event|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
11102435|NCT01597687|BG000|Baseline|Malaysia Group|Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
11102436|NCT01597687|BG001|Baseline|Taiwan Group|Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.
11102437|NCT01597687|BG002|Baseline|Thailand Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.
11102438|NCT01597687|BG003|Baseline|Total|Total of all reporting groups
11102439|NCT01597687|FG000|Participant Flow|Malaysia Group|Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
11102440|NCT01597687|FG001|Participant Flow|Taiwan Group|Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.
10846732|NCT00279500|OG000|Outcome|Argus 16 Retinal Stimulation System|Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells.
11102441|NCT01597687|FG002|Participant Flow|Thailand Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.
11102442|NCT01597687|OG000|Outcome|Malaysia Group|Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
11102443|NCT01597687|OG001|Outcome|Taiwan Group|Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.
11102444|NCT01597687|OG002|Outcome|Thailand Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.
11102445|NCT01597687|OG000|Outcome|Subjects With Sero-confirmed Infection|Adults aged >19 years with prolonged cough of 2 weeks or more, with with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml.
11102446|NCT01597687|OG001|Outcome|Subjects With Non-sero-confirmed Infection|Adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels < 62.5 IU/m
11102447|NCT01597687|OG000|Outcome|Malaysian Sero-confirmed Subjects Group|Malaysian adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102448|NCT01597687|OG001|Outcome|Taiwanese Sero-confirmed Subjects Group|Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102449|NCT01597687|OG002|Outcome|Thailandese Sero-confirmed Subjects Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102450|NCT01597687|OG000|Outcome|Malaysia Sero-confirmed Subjects Group|Malaysian adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml.
11102451|NCT01597687|OG001|Outcome|Taiwan Sero-confirmed Subjects Group|Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml.
11102452|NCT01597687|OG002|Outcome|Thailand Sero-confirmed Subjects Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml.
11102453|NCT01597687|OG000|Outcome|Malaysia Sero-confirmed Subjects Group|Malaysian adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102454|NCT01597687|OG001|Outcome|Taiwan Sero-confirmed Subjects Group|Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102455|NCT01597687|OG002|Outcome|Thailand Sero-confirmed Subjects Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more, with anti-pertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102456|NCT01597687|OG000|Outcome|Malaysian Sero-confirmed Subjects Group|Malaysian adults aged >19 years with prolonged cough of 2 weeks or more, with antipertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102457|NCT01597687|OG001|Outcome|Taiwanese Sero-confirmed Subjects Group|Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more, with antipertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102458|NCT01597687|OG002|Outcome|Thailandese Sero-confirmed Subjects Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more, with antipertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102459|NCT01597687|OG002|Outcome|Thailandese Sero-confirmed Subjects Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more, with antipertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml.
11102460|NCT01597687|OG002|Outcome|Thailandese Sero-confirmed Subjects Group|Thailandese adul ts aged >19 years with prolonged cough of 2 weeks or more, with antipertussis Immunoglobulin G ELISA levels ≥62.5 IU/ml
11102461|NCT01597687|EG000|Reported Event|Malaysia Group|Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
11102462|NCT01597687|EG001|Reported Event|Taiwan Group|Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.
11102463|NCT01597687|EG002|Reported Event|Thailand Group|Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.
11102464|NCT01597791|BG000|Baseline|Foley Catheter|"Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.~Foley catheter: Foley catheter placement after CSE."
11102465|NCT01597791|BG001|Baseline|No Foley Catheter|"Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.~No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals."
11102466|NCT01597791|BG002|Baseline|Total|Total of all reporting groups
11102467|NCT01597791|FG000|Participant Flow|Foley Catheter|"Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.~Foley catheter: Foley catheter placement after CSE."
11102468|NCT01597791|FG001|Participant Flow|No Foley Catheter|"Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.~No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals."
11102469|NCT01597791|OG000|Outcome|Foley Catheter|"Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.~Foley catheter: Foley catheter placement after CSE."
11102470|NCT01597791|OG001|Outcome|No Foley Catheter|"Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.~No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals."
11102471|NCT01597791|EG000|Reported Event|Foley Catheter|"Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.~Foley catheter: Foley catheter placement after CSE."
11102472|NCT01597791|EG001|Reported Event|No Foley Catheter|"Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.~No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals."
11102473|NCT01597843|BG000|Baseline|First Educational Intervention Group|"Group that receives intervention first. The intervention is a series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV.~Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
11102474|NCT01597843|BG001|Baseline|Second Intervention Group|"The group that receives the intervention second. The intervention is the same as for the first group.~Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
11102475|NCT01597843|BG002|Baseline|Education After Data Collection Complete|This group received a similar intervention, but after all quantitative data collection complete.
11102476|NCT01597843|BG003|Baseline|Total|Total of all reporting groups
11102477|NCT01597843|FG000|Participant Flow|Education in First Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 1-5. They completed survey round 1 before receiving the intervention and survey rounds 2 and 3 after receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
11102478|NCT01597843|FG001|Participant Flow|Control First Round; Education in Second Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 6-9. They completed survey rounds 1 and 2 before receiving the intervention and survey round 3 after they received the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
11102479|NCT01597843|FG002|Participant Flow|Control First Round; Control Second Round; Intervention|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
11102480|NCT01597843|OG000|Outcome|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
11102481|NCT01597843|OG001|Outcome|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
11102482|NCT01597843|OG002|Outcome|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
11102483|NCT01597843|EG000|Reported Event|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
11102484|NCT01597843|EG001|Reported Event|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
11102485|NCT01597843|EG002|Reported Event|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
11102486|NCT01597856|BG000|Baseline|SBIRT|"The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver.~Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing.~SBIRT: SBIRT Therapy overview-~Therapist explains purpose of the therapy.~Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.~Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.~Discuss treatment needs, administer screening, provide feedback."
11102487|NCT01597856|BG001|Baseline|No Additional Treatment|Veterans assigned to the control condition will not receive any study-related therapy. A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.
11102488|NCT01597856|BG002|Baseline|Not Randomized|Veterans enrolled who did not report risky substance use at baseline.
11102489|NCT01597856|BG003|Baseline|Total|Total of all reporting groups
11102490|NCT01597856|FG000|Participant Flow|SBIRT|"The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver.~Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing.~SBIRT: SBIRT Therapy overview-~Therapist explains purpose of the therapy.~Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.~Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.~Discuss treatment needs, administer screening, provide feedback."
11102491|NCT01597856|FG001|Participant Flow|No Additional Treatment|Veterans assigned to the control condition will not receive any study-related therapy. A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.
11102492|NCT01597856|FG002|Participant Flow|Not Randomized|Enrolled Veterans with no risky substance use.
11102493|NCT01597856|OG000|Outcome|SBIRT|Intervention Group
11102494|NCT01597856|OG001|Outcome|No Additional Treatment|Control Group (Randomized, no intervention)
11102495|NCT01597856|OG002|Outcome|Not Randomized|Comparison Group (no risky substance use at baseline)
11102496|NCT01597856|OG001|Outcome|No Additional Treatment|Control Group (randomized, no intervention)
11102497|NCT01597856|EG000|Reported Event|SBIRT|"The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver.~Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing.~SBIRT: SBIRT Therapy overview-~Therapist explains purpose of the therapy.~Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.~Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.~Discuss treatment needs, administer screening, provide feedback."
11102498|NCT01597856|EG001|Reported Event|No Additional Treatment|Veterans assigned to the control condition will not receive any study-related therapy. A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.
11102499|NCT01597856|EG002|Reported Event|Not Randomized|Veterans reporting no risky substance use at baseline.
11102500|NCT01597908|BG000|Baseline|Dabrafenib Plus Trametinib|Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11102501|NCT01597908|BG001|Baseline|Vemurafenib|Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11102502|NCT01597908|BG002|Baseline|Total|Total of all reporting groups
11102503|NCT01597908|FG000|Participant Flow|Dabrafenib Plus Trametinib|Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11102504|NCT01597908|FG001|Participant Flow|Vemurafenib|Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11102505|NCT01597908|FG002|Participant Flow|Crossover Dabrafenib Plus Trametinib|With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
11102506|NCT01597908|OG000|Outcome|Dabrafenib Plus Trametinib|Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11102507|NCT01597908|OG001|Outcome|Vemurafenib|Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11102508|NCT01597908|OG002|Outcome|Crossover Dabrafenib + Trametinib|With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
11102509|NCT01597908|EG000|Reported Event|Dabrafenib Plus Trametinib|Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11102510|NCT01597908|EG001|Reported Event|Vemurafenib|Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
11102511|NCT01597908|EG002|Reported Event|Crossover Dabrafenib Plus Trametinib|With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
11102512|NCT01597908|EG003|Reported Event|All Patients|All randomized patients who received at least one dose of study treatment.
11102513|NCT01597973|BG000|Baseline|Colistin and Placebo|colistin and placebo: colistin- loading dose standard, maintenance dosed based on patient's renal function placebo- mimic meropenem (blinded)
11102514|NCT01597973|BG001|Baseline|Colistin and a Carbapenem|colistin and a carbapenem: colistin standard loading dose, maintenance dose based on patient's renal function carbapenem- dose based on patient's renal function
11102515|NCT01597973|BG002|Baseline|Total|Total of all reporting groups
11102516|NCT01597973|FG000|Participant Flow|Colistin and Placebo|colistin and placebo: colistin- loading dose standard, maintenance dosed based on patient's renal function placebo- mimic meropenem (blinded)
11102517|NCT01597973|FG001|Participant Flow|Colistin and a Carbapenem|colistin and a carbapenem: colistin standard loading dose, maintenance dose based on patient's renal function carbapenem- dose based on patient's renal function
11102518|NCT01597973|OG000|Outcome|Colistin and Placebo|colistin and placebo: colistin- loading dose standard, maintenance dose based on patient's renal function placebo- mimic meropenem (blinded)
11102519|NCT01597973|OG001|Outcome|Colistin and a Carbapenem|colistin and a carbapenem: colistin standard loading dose, maintenance dose based on patient's renal function carbapenem- dose based on patient's renal function
11102520|NCT01597973|OG000|Outcome|Colistin and Placebo|colistin and placebo: colistin- loading dose standard, maintenance dosed based on patient's renal function placebo-mimic meropenem (blinded)
11102521|NCT01597973|OG000|Outcome|Colistin and Placebo|colistin and placebo: colistin- loading dose standard, maintenance dosed based on patient's renal function placebo- mimic meropenem (blinded)
11102522|NCT01597973|EG000|Reported Event|Colistin and Placebo|colistin and placebo: colistin- loading dose standard, maintenance dosed based on patient's renal function placebo- mimic meropenem (blinded)
11102523|NCT01597973|EG001|Reported Event|Colistin and a Carbapenem|colistin and carbapenem: colistin standard loading dose, maintenance dose based on patient's renal function carbapenem- dose based on patient's renal function
11102524|NCT01598064|BG000|Baseline|GK#10|GK#10 1 pk tid for 8 weeks
11102525|NCT01598064|BG001|Baseline|Placebo|Placebo 1 pack tid for 8 weeks
11102526|NCT01598064|BG002|Baseline|Total|Total of all reporting groups
11102527|NCT01598064|FG000|Participant Flow|GK#10|GK#10 1 pk tid for 8 weeks
11102528|NCT01598064|FG001|Participant Flow|Placebo|Placebo 1 pack tid for 8 weeks
11102529|NCT01598064|OG000|Outcome|GK#10|GK#10 1 pk tid for 8 weeks
11102530|NCT01598064|OG001|Outcome|Placebo|Placebo 1 pack tid for 8 weeks
11102531|NCT01598064|OG000|Outcome|GK#10: 8 Week|GK#10 1 pack three times per day for 8 weeks, and F/U ALT level.
11102532|NCT01598064|OG001|Outcome|Placebo: 8 Week|Placebo 1 pack three times per day for 8 weeks, and F/U ALT level.
11102533|NCT01598064|EG000|Reported Event|GK#10|GK#10 1 pk tid for 8 weeks
11102534|NCT01598064|EG001|Reported Event|Placebo|Placebo 1 pack tid for 8 weeks
11102535|NCT01598090|BG000|Baseline|Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)|Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102536|NCT01598090|BG001|Baseline|Part B: Peginterferon Lambda-1a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102537|NCT01598090|BG002|Baseline|Part B: Peginterferon Alfa-2a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102538|NCT01598090|BG003|Baseline|Total|Total of all reporting groups
11102539|NCT01598090|FG000|Participant Flow|Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)|Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102540|NCT01598090|FG001|Participant Flow|Part B: Peginterferon Lambda-1a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102541|NCT01598090|FG002|Participant Flow|Part B: Peginterferon Alfa-2a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102542|NCT01598090|OG000|Outcome|Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)|Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102543|NCT01598090|OG000|Outcome|Part B: Peginterferon Lambda-1a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102544|NCT01598090|OG001|Outcome|Part B: Peginterferon Alfa-2a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102545|NCT01598090|OG000|Outcome|Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)|Participants were followed up for 48 weeks who received treatment as: Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
11102546|NCT01598090|OG001|Outcome|Part B: Peginterferon Lambda-1a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11126469|NCT01733472|BG001|Baseline|GA-arm, Remifentanil|"GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol~GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the Marsh and Minto algorithm"
11102547|NCT01598090|OG002|Outcome|Part B: Peginterferon Alfa-2a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102548|NCT01598090|EG000|Reported Event|Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)|Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102549|NCT01598090|EG001|Reported Event|Part B: Peginterferon Lambda-1a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102550|NCT01598090|EG002|Reported Event|Part B: Peginterferon Alfa-2a + RBV + TVR|Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
11102551|NCT01598129|BG000|Baseline|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
11102552|NCT01598129|FG000|Participant Flow|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
11102553|NCT01598129|OG000|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
11102554|NCT01598129|OG000|Outcome|CGTG-102|"CGTG-102 dose escalation~ONCOS-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
11102555|NCT01598129|EG000|Reported Event|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
11102556|NCT01598194|BG000|Baseline|Standard Suction Technique (SST)|SST: 2 passes with 25G for cytology, 1 pass each with 22Gpc for cytology and histology. Diagnostic adequacy scores compared by technique and by needle
11102557|NCT01598194|BG001|Baseline|Capillary Suction Technique (CST)|CST: 2 passes with 25G for cytology, 1 pass each with 22Gpc for cytology and histology. Diagnostic adequacy scores compared by technique and by needle
11102558|NCT01598194|BG002|Baseline|Total|Total of all reporting groups
11102559|NCT01598194|FG000|Participant Flow|Standard Suction Technique (SST)|P30 participants randomized to SST (Standard Suction Technique)
11102560|NCT01598194|FG001|Participant Flow|Capillary Suction Technique (CST)|30 participants randomized to CST (Capillary Suction Technique
11102561|NCT01598194|OG000|Outcome|Standard Suction Technique (SST) Cytology|1 pass with 22Gpc for cytology, 1 pass with 22Gpc for histology using SST or CST. Diagnostic adequacy scores compared by technique for cytology and histology.
11102562|NCT01598194|OG001|Outcome|Capillary Suction Technique (CST)|30 participants randomized to CST (Capillary Suction Technique)
11102563|NCT01598194|OG000|Outcome|Standard Suction Technique (SST) Histology|1 pass with 22Gpc for histology using SST. Diagnostic adequacy scores compared by technique for histology.
11102564|NCT01598194|OG001|Outcome|Capillary Suction Technique (CST) Histology|1 pass with 22Gpc for histology using CST. Diagnostic adequacy scores compared by technique for histology.
11102565|NCT01598194|OG000|Outcome|22G Procore Needle|All patients: comparison of diagnostic adequacy of a single pass with a 22Gpc needle versus best of 2 passes with a standard 25G needle for cytological diagnosis.
11102566|NCT01598194|OG001|Outcome|Standard 25G Needle|All patients: comparison of diagnostic adequacy of a single pass with a 22Gpc needle versus best of 2 passes with a standard 25G needle for cytological diagnosis.
11102567|NCT01598194|EG000|Reported Event|Standard Suction Technique (SST)|Participants who are referred for EUS-FNA and consented will have their examination performed using two different needles: with the standard 22-gauge or 25-gauge straight hollow core needle
11102568|NCT01598194|EG001|Reported Event|Capillary Suction Technique (CST)|Participants who are referred for EUS-FNA and consented will have their examination performed using two different needles: with the standard 22-gauge or 25-gauge straight hollow core needle
11102569|NCT01598207|BG000|Baseline|Marinol|Marinol: 5mg BID, orally for 1 month
11102570|NCT01598207|BG001|Baseline|Placebo|Placebo: 5mg BID, orally for 1 month
11102571|NCT01598207|BG002|Baseline|Total|Total of all reporting groups
11102572|NCT01598207|FG000|Participant Flow|Marinol|Marinol: 5mg BID, orally for 1 month
11102573|NCT01598207|FG001|Participant Flow|Placebo|Placebo: 5mg BID, orally for 1 month
11102574|NCT01598207|OG000|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
11102575|NCT01598207|OG001|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
11102576|NCT01598207|EG000|Reported Event|Marinol|Marinol: 5mg BID, orally for 1 month
11102577|NCT01598207|EG001|Reported Event|Placebo|Placebo: 5mg BID, orally for 1 month
11102578|NCT01598298|BG000|Baseline|Arm I: Duloxetine|"Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.~duloxetine hydrochloride: Given PO"
11102579|NCT01598298|BG001|Baseline|Arm II: Placebo|"Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.~placebo: Given PO"
11102580|NCT01598298|BG002|Baseline|Total|Total of all reporting groups
11102581|NCT01598298|FG000|Participant Flow|Arm I: Duloxetine|"Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.~duloxetine hydrochloride: Given PO"
11102582|NCT01598298|FG001|Participant Flow|Arm II: Placebo|"Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.~placebo: Given PO"
11102583|NCT01598298|OG000|Outcome|Arm I: Duloxetine|"Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.~duloxetine hydrochloride: Given PO"
11102584|NCT01598298|OG001|Outcome|Arm II: Placebo|"Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.~placebo: Given PO"
11102585|NCT01598298|EG000|Reported Event|Arm II: Placebo|Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
11102586|NCT01598298|EG001|Reported Event|Arm I: Duloxetine|Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO
11102587|NCT01598311|BG000|Baseline|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
11102588|NCT01598311|BG001|Baseline|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
11102589|NCT01598311|BG002|Baseline|Total|Total of all reporting groups
11102590|NCT01598311|FG000|Participant Flow|CB-183,315|Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo b.i.d. by mouth for 10 days.
11102591|NCT01598311|FG001|Participant Flow|Vancomycin|Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
11102592|NCT01598311|OG000|Outcome|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
11102593|NCT01598311|OG001|Outcome|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
11102594|NCT01598311|EG000|Reported Event|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
11102595|NCT01598311|EG001|Reported Event|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
11102596|NCT01598350|BG000|Baseline|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
11102597|NCT01598350|FG000|Participant Flow|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
11102598|NCT01598350|OG000|Outcome|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
11102599|NCT01598350|EG000|Reported Event|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
11102600|NCT01598428|BG000|Baseline|Cataract|
11102601|NCT01598428|FG000|Participant Flow|Cataract|During cataract surgery, the anterior capsule was unpolished intraoperatively in one eye; the anterior capsule and the equator of capsule was extensively polished intraoperatively in the other eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
11102602|NCT01598428|OG000|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
11102603|NCT01598428|OG001|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
11102604|NCT01598428|EG000|Reported Event|Cataract|
11102605|NCT01598506|BG000|Baseline|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
11102606|NCT01598506|FG000|Participant Flow|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
11102607|NCT01598506|OG000|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 10.9 (95% CI +/- 1.2 mcg)."
11102608|NCT01598506|OG000|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
11102609|NCT01598506|EG000|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
11102610|NCT01598532|BG000|Baseline|Transcranial LED Treatment|"All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month & 2 months following the last LED treatment.~The neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free & Cued Recall, Long Delay Free & Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), & 5) Digit Span, Forwards & Backwards.~The following tests were not analyzed due to collinearity with other measures (r > .8): Short Delay Free & Cued Recall, Long Delay Cued Recall, & Delis-Kaplan Executive Function (D-KEF) -Trails Test."
11102611|NCT01598532|FG000|Participant Flow|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
11102612|NCT01598532|OG000|Outcome|Transcranial LED Treatment|MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
11126470|NCT01733472|BG002|Baseline|Total|Total of all reporting groups
11102613|NCT01598532|OG000|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
11102614|NCT01598532|OG000|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
11102615|NCT01598532|OG000|Outcome|Transcranial LED Treatment|"All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.~MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each."
11102616|NCT01598532|EG000|Reported Event|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
11102617|NCT01598545|BG000|Baseline|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
11102618|NCT01598545|FG000|Participant Flow|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
11102619|NCT01598545|OG000|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
11102620|NCT01598545|EG000|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
11102621|NCT01598610|BG000|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
11102622|NCT01598610|FG000|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
11102623|NCT01598610|OG000|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
11102624|NCT01598610|EG000|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
11102625|NCT01598662|BG000|Baseline|IUD Insertion 6 Weeks After Delivery|Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later.
11102626|NCT01598662|BG001|Baseline|Immediate Post-placental Insertion|Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed
11102627|NCT01598662|BG002|Baseline|Total|Total of all reporting groups
11102628|NCT01598662|FG000|Participant Flow|IUD Insertion 6 Weeks After Delivery|"Device:Levonorgestrel-releasing intrauterine device marketed as Mirena. Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. They must return for one visit within a month for a string check"
11102629|NCT01598662|FG001|Participant Flow|Immediate Post-Placental Insertion|Device: Levonorgestrel-releasing intrauterine device marketed as Mirena Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed manually under sterile technique and with ultrasound guidance. An ultrasound will be performed within two days postpartum to verify proper placement and again at approximately six weeks postpartum
11102630|NCT01598662|OG000|Outcome|IUD Insertion 6 Weeks After Delivery|Subjects randomized had their IUD placed in the office at six weeks postpartum or later.
11102631|NCT01598662|OG001|Outcome|Immediate Post-placental Insertion|Subjects randomized to immediate post-placental placement within 10 minutes of delivery had an IUD placed manually under sterile technique and with ultrasound guidance
11102632|NCT01598662|EG000|Reported Event|IUD Insertion 6 Weeks After Delivery|Subjects randomized had their IUD placed in the office at six weeks postpartum or later.
11102633|NCT01598662|EG001|Reported Event|Immediate Post-placental Insertion|Subjects randomized to immediate post-placental placement within 10 minutes of delivery had an IUD placed manually under sterile technique and with ultrasound guidance
11102634|NCT01598701|BG000|Baseline|Intravenous Acetaminophen|"Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.~Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes."
11102635|NCT01598701|BG001|Baseline|Placebo|"Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.~Placebo: 100 mL 0.9% Sodium Chloride"
11102636|NCT01598701|BG002|Baseline|Total|Total of all reporting groups
11102637|NCT01598701|FG000|Participant Flow|Intravenous Acetaminophen|"Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.~Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes."
11102638|NCT01598701|FG001|Participant Flow|Placebo|"Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.~Placebo: 100 mL 0.9% Sodium Chloride"
11102639|NCT01598701|OG000|Outcome|Intravenous Acetaminophen|"Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.~Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes."
11102640|NCT01598701|OG001|Outcome|Placebo|"Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.~Placebo: 100 mL 0.9% Sodium Chloride"
11102641|NCT01598701|EG000|Reported Event|Intravenous Acetaminophen|"Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.~Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes."
11102642|NCT01598701|EG001|Reported Event|Placebo|"Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.~Placebo: 100 mL 0.9% Sodium Chloride"
11102643|NCT01598740|BG000|Baseline|CLP + Spiro/CLP|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
11102644|NCT01598740|BG001|Baseline|CLP/CLP + Spiro|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
11102645|NCT01598740|BG002|Baseline|Total|Total of all reporting groups
11102646|NCT01598740|FG000|Participant Flow|CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days)|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
11102647|NCT01598740|FG001|Participant Flow|CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days)|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
11102648|NCT01598740|OG000|Outcome|Treatment Group: CLP Alone|oral administration
11102649|NCT01598740|OG001|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
11102650|NCT01598740|OG000|Outcome|Treatment Group: CLP Alone|CLP: oral administration
11102651|NCT01598740|EG000|Reported Event|Treatment Group: CLP Alone|oral administration
11102652|NCT01598740|EG001|Reported Event|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
11102653|NCT01598753|BG000|Baseline|Placebo and Health Education|Participants received a matching placebo and 8 weekly 50 minute sessions of health education on Fibromyalgia.
11102654|NCT01598753|BG001|Baseline|Tramadol and Health Education|Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia.
11102655|NCT01598753|BG002|Baseline|Placebo and Cognitive Behavioral Therapy|Participants received matching placebo and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients.
11102656|NCT01598753|BG003|Baseline|Tramadol and Cognitive Behavioral Therapy|Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients.
11102657|NCT01598753|BG004|Baseline|Total|Total of all reporting groups
11102658|NCT01598753|FG000|Participant Flow|Placebo and Health Education|Participants received a matching placebo and 8 weekly 50 minute sessions of health education on Fibromyalgia.
11102659|NCT01598753|FG001|Participant Flow|Tramadol and Health Education|Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia.
11102660|NCT01598753|FG002|Participant Flow|Placebo and Cognitive Behavioral Therapy|Participants received matching placebo and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients.
11102661|NCT01598753|FG003|Participant Flow|Tramadol and Cognitive Behavioral Therapy|Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients.
11102662|NCT01598753|OG000|Outcome|Placebo and Health Education|Participants received a matching placebo and 8 weekly 50 minute sessions of health education on Fibromyalgia.
11102663|NCT01598753|OG001|Outcome|Tramadol and Health Education|Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia.
11102664|NCT01598753|OG002|Outcome|Placebo and Cognitive Behavioral Therapy|Participants received matching placebo and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients.
11102665|NCT01598753|OG003|Outcome|Tramadol and Cognitive Behavioral Therapy|Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients.
11102666|NCT01598753|EG000|Reported Event|Placebo and Health Education|Participants received a matching placebo and 8 weekly 50 minute sessions of health education on Fibromyalgia.
11102667|NCT01598753|EG001|Reported Event|Tramadol and Health Education|Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia.
11102668|NCT01598753|EG002|Reported Event|Placebo and Cognitive Behavioral Therapy|Participants received matching placebo and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients.
11102669|NCT01598753|EG003|Reported Event|Tramadol and Cognitive Behavioral Therapy|Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients.
11102670|NCT01598779|BG000|Baseline|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
11126471|NCT01733472|FG000|Participant Flow|RA-arm|"RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg~placebo"
11102671|NCT01598779|FG000|Participant Flow|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
11102672|NCT01598779|OG000|Outcome|Women With External Genital Warts|"Women age 15-45 attending an outpatient consultation at clinics of the investigators or at University of Buenos Aires, with a lesion suspected of being HPV related were eligible to enter in the study. The main manifestations of genital warts include cauliflower-like condylomata acuminata lesions, keratotic and smooth papular warts, subclinical flat warts, Patients previously vaccinated with commercially available vaccines (Gardasil™ or Cervarix™) were not invited to participate.~Inclusion criteria: women between 15 and 45 years old, with External Genital Warts. We will exclude women under treatment corticosteroids, having an immunosuppressive disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known"
11102673|NCT01598779|EG000|Reported Event|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
11102674|NCT01598831|BG000|Baseline|ART-123|ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
11102675|NCT01598831|BG001|Baseline|Placebo|Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
11102676|NCT01598831|BG002|Baseline|Total|Total of all reporting groups
11102677|NCT01598831|FG000|Participant Flow|ART-123|ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
11102678|NCT01598831|FG001|Participant Flow|Placebo|Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
11102679|NCT01598831|OG000|Outcome|ART-123|ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
11102680|NCT01598831|OG001|Outcome|Placebo|Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
11102681|NCT01598831|EG000|Reported Event|ART-123|ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
11102682|NCT01598831|EG001|Reported Event|Placebo|Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
11102683|NCT01598896|BG000|Baseline|Dronabinol + Clonidine|"Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily~Dronabinol: Dronabinol titrated to 5 mg three times daily~Clonidine: Clonidine 0.1 mg twice daily"
11102684|NCT01598896|BG001|Baseline|Placebo|"Placebo~Placebo: One placebo capsule by mouth twice daily"
11102685|NCT01598896|BG002|Baseline|Total|Total of all reporting groups
11102686|NCT01598896|FG000|Participant Flow|Dronabinol-Clonidine|"Dronabinol titrated to 5 mg three times daily~Dronabinol: Dronabinol titrated to 5 mg three times daily~Clonidine 0.1 mg twice daily~Clonidine: Clonidine 0.1 mg twice daily"
11102687|NCT01598896|FG001|Participant Flow|Placebo|"Placebo~Placebo: One placebo capsule by mouth twice daily"
11102688|NCT01598896|OG000|Outcome|Dronabinol + Clonidine|"Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily~Dronabinol: Dronabinol titrated to 5 mg three times daily~Clonidine: Clonidine 0.1 mg twice daily"
11102689|NCT01598896|OG001|Outcome|Placebo|"Placebo~Placebo: One placebo capsule by mouth twice daily"
11102690|NCT01598896|EG000|Reported Event|Dronabinol + Clonidine|"Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily~Dronabinol: Dronabinol titrated to 5 mg three times daily~Clonidine: Clonidine 0.1 mg twice daily"
11102691|NCT01598896|EG001|Reported Event|Placebo|"Placebo~Placebo: One placebo capsule by mouth twice daily"
11102692|NCT01598922|BG000|Baseline|Internet Cognitive Behavioral Therapy|Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.
11102693|NCT01598922|BG001|Baseline|Monitored Attention Control|Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
11102694|NCT01598922|BG002|Baseline|Total|Total of all reporting groups
11102695|NCT01598922|FG000|Participant Flow|Internet Cognitive Behavioral Therapy|Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.
11126472|NCT01733472|FG001|Participant Flow|GA-arm, Remifentanil|"GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol~GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the Marsh and Minto algorithm"
11102696|NCT01598922|FG001|Participant Flow|Monitored Attention Control|Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
11102697|NCT01598922|OG000|Outcome|Internet Cognitive Behavioral Therapy|Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.
11102698|NCT01598922|OG001|Outcome|Monitored Attention Control|Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
11102699|NCT01598922|EG000|Reported Event|Internet Cognitive Behavioral Therapy|Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.
11102700|NCT01598922|EG001|Reported Event|Monitored Attention Control|Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
11102701|NCT01598987|BG000|Baseline|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
11102702|NCT01598987|FG000|Participant Flow|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
11102703|NCT01598987|OG000|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
11102704|NCT01598987|OG000|Outcome|<=5% Percentile|Growth percentile category
11102705|NCT01598987|OG001|Outcome|>5% - 25% Percentile|Growth percentile category
11102706|NCT01598987|OG002|Outcome|>25% - 50% Percentile|Growth percentile category
11102707|NCT01598987|OG003|Outcome|>50% - 75% Percentile|Growth percentile categpru
11102708|NCT01598987|OG004|Outcome|>75% - 95% Percentile|Growth percentile category
11102709|NCT01598987|OG005|Outcome|>95% Percentile|Growth percentile category
11102710|NCT01598987|OG006|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
11102711|NCT01598987|EG000|Reported Event|All Patients|All patients
11102712|NCT01599104|BG000|Baseline|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
11102713|NCT01599104|BG001|Baseline|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
11102714|NCT01599104|BG002|Baseline|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
11102715|NCT01599104|BG003|Baseline|Total|Total of all reporting groups
11102716|NCT01599104|FG000|Participant Flow|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
11102717|NCT01599104|FG001|Participant Flow|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
11102718|NCT01599104|FG002|Participant Flow|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
11102719|NCT01599104|OG000|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
11102720|NCT01599104|OG001|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
11102721|NCT01599104|OG002|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
11102722|NCT01599104|EG000|Reported Event|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
11102723|NCT01599104|EG001|Reported Event|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
11102724|NCT01599104|EG002|Reported Event|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
11102725|NCT01599234|BG000|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
11102726|NCT01599234|BG001|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
11102727|NCT01599234|BG002|Baseline|Total|Total of all reporting groups
11102728|NCT01599234|FG000|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
11102729|NCT01599234|FG001|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
11126473|NCT01733472|OG000|Outcome|RA-arm|"RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg~placebo"
11102730|NCT01599234|OG000|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
11102731|NCT01599234|OG001|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
11102732|NCT01599234|EG000|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
11102733|NCT01599234|EG001|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
11102734|NCT01599286|BG000|Baseline|Episodes of N-carbamylglutamate (NCG)|"Total number of episodes of hyperammonemia where a patient was randomized to the NCG arm~A daily dose of 150 mg/kg/ day or 3.3 g/m2/day for patients >15 kg administered for 7 days or until discharge, whichever is sooner."
11102735|NCT01599286|BG001|Baseline|Episodes of Placebo|"Total number of episodes of hyperammonemia where a patient was randomized to the placebo arm~Placebo that looks/tastes the same as NCG and is administered on the same schedule as the NCG intervention"
11102736|NCT01599286|BG002|Baseline|Total|Total of all reporting groups
11102737|NCT01599286|FG000|Participant Flow|Episodes of N-Carbamylglutamate|Episodes where the participant was randomized to the NCG arm
11102738|NCT01599286|FG001|Participant Flow|Episodes of Placebo|Episodes where the participant was randomized to the placebo arm
11102739|NCT01599286|OG000|Outcome|PA/MMA Episodes|All episodes where a patient diagnosed with PA/MMA was randomized to either placebo or NCG
11102740|NCT01599286|OG001|Outcome|CPS1D/OTCD Episodes|All episodes where a patient diagnosed with CPS1D/OTCD was randomized to either placebo or NCGPatients PA/MMA who received study drug
11102741|NCT01599286|EG000|Reported Event|Placebo|Episodes where the patient was randomized to placebo
11102742|NCT01599286|EG001|Reported Event|N-carbamylglutamate (NCG)|Episodes where the patient was randomized to NCG
11102743|NCT01599325|BG000|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
11102744|NCT01599325|FG000|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
11102745|NCT01599325|OG000|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
11102746|NCT01599325|EG000|Reported Event|Azacitidine - Parent Phase|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
11102747|NCT01599325|EG001|Reported Event|Azacitdine - Extension Phase|Azacitidine 75 mg/m^2/day subcutaneously for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation
11102748|NCT01599585|BG000|Baseline|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
11102749|NCT01599585|BG001|Baseline|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
11102750|NCT01599585|BG002|Baseline|Total|Total of all reporting groups
11102751|NCT01599585|FG000|Participant Flow|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
11102752|NCT01599585|FG001|Participant Flow|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
11102753|NCT01599585|OG000|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
11102754|NCT01599585|OG001|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
11102755|NCT01599585|EG000|Reported Event|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
11102756|NCT01599585|EG001|Reported Event|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
11102757|NCT01599637|BG000|Baseline|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
11102758|NCT01599637|BG001|Baseline|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
11102759|NCT01599637|BG002|Baseline|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
11102760|NCT01599637|BG003|Baseline|Total|Total of all reporting groups
11102761|NCT01599637|FG000|Participant Flow|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
11102762|NCT01599637|FG001|Participant Flow|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
11102763|NCT01599637|FG002|Participant Flow|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
11102764|NCT01599637|OG000|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
11102765|NCT01599637|OG001|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
11102766|NCT01599637|OG000|Outcome|IGE025|Dosed every 4 weeks up to 12 weeks
11102767|NCT01599637|OG001|Outcome|Placebo IGE025|Dosed every 4 weeks up to 12 weeks
11102768|NCT01599637|OG000|Outcome|Healthy Subjects|Baseline Value, healthy volunteers, no treatment applied
11102769|NCT01599637|OG001|Outcome|Urticaria Patients|All patients for study at baseline
11102770|NCT01599637|EG000|Reported Event|IGE025 300mg|IGE025 administered subcutaneously every 4 weeks at the study center
11102771|NCT01599637|EG001|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks at the study center.
11102772|NCT01599650|BG000|Baseline|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
11102773|NCT01599650|BG001|Baseline|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
11102774|NCT01599650|BG002|Baseline|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
11102775|NCT01599650|BG003|Baseline|Total|Total of all reporting groups
11102776|NCT01599650|FG000|Participant Flow|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
11102777|NCT01599650|FG001|Participant Flow|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
11102778|NCT01599650|FG002|Participant Flow|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
11102779|NCT01599650|OG000|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
11102780|NCT01599650|OG001|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
11102781|NCT01599650|OG002|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
11102782|NCT01599650|OG000|Outcome|3- Laser Monotherapy|laser therapy + Ranibizumab 0.5 mg after Month 6
11102783|NCT01599650|EG000|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
11102784|NCT01599650|EG001|Reported Event|Ranibizumab 0.5mg + Laser|"Ranibizumab 0.5mg + Laser~[1] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages > 100% for the ranibizumab + laser arm."
11102785|NCT01599650|EG002|Reported Event|Laser Monotherapy With Ranibizumab 0.5 mg From Month 6|Laser monotherapy with Ranibizumab 0.5 mg from Month 6
11102786|NCT01599650|EG003|Reported Event|Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6|Laser monotherapy without Ranibizumab 0.5 mg from Month 6
11102787|NCT01599754|BG000|Baseline|Axitinib|Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. .
11102788|NCT01599754|BG001|Baseline|Placebo|Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
11102789|NCT01599754|BG002|Baseline|Total|Total of all reporting groups
11102790|NCT01599754|FG000|Participant Flow|Axitinib|Participants at high risk of recurrent renal cell carcinoma (RCC) received Axitinib 5 milligram (mg) twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
11102791|NCT01599754|FG001|Participant Flow|Placebo|Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
11102792|NCT01599754|OG000|Outcome|Axitinib|Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
11102793|NCT01599754|OG001|Outcome|Placebo|Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
11102794|NCT01599754|EG000|Reported Event|Axitinib|Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
11102795|NCT01599754|EG001|Reported Event|Placebo|Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
11102796|NCT01599793|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~cabozantinib: Given PO~laboratory biomarker analysis: Correlative studies~magnetic resonance imaging: Undergo MRI"
11102797|NCT01599793|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~cabozantinib: Given PO~laboratory biomarker analysis: Correlative studies~magnetic resonance imaging: Undergo MRI"
11102798|NCT01599793|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~cabozantinib: Given PO~laboratory biomarker analysis: Correlative studies~magnetic resonance imaging: Undergo MRI"
11102799|NCT01599793|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~cabozantinib: Given PO~laboratory biomarker analysis: Correlative studies~magnetic resonance imaging: Undergo MRI"
11102800|NCT01599806|BG000|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
11102801|NCT01599806|BG001|Baseline|Doripenem|Doripenem treatment group
11102802|NCT01599806|BG002|Baseline|Total|Total of all reporting groups
11102803|NCT01599806|FG000|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
11102804|NCT01599806|FG001|Participant Flow|Doripenem|Doripenem treatment group
11102805|NCT01599806|OG000|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
11102806|NCT01599806|OG001|Outcome|Doripenem|Doripenem treatment group
11102807|NCT01599806|EG000|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
11102808|NCT01599806|EG001|Reported Event|Doripenem|Doripenem treatment group
11102809|NCT01599832|BG000|Baseline|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
11102810|NCT01599832|FG000|Participant Flow|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
11102811|NCT01599832|OG000|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
11102812|NCT01599832|EG000|Reported Event|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
11102813|NCT01600014|BG000|Baseline|Ingenol Mebutate 0.015% Gel (1.& 2. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or controlled repeat use (2nd cycle) treatment of recalcitrant or recurrent AK lesions
11126474|NCT01733472|OG001|Outcome|GA-arm, Remifentanil|"GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol~GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the Marsh and Minto algorithm"
11004109|NCT01075321|OG002|Outcome|Phase I: Dose Level 1|Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004110|NCT01075321|OG003|Outcome|Phase II: Dose Level 0|Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004111|NCT01075321|OG000|Outcome|Dose Level 0|Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004112|NCT01075321|OG000|Outcome|All Patients (Everolimus and Lenalidomide)|Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004113|NCT01075321|EG000|Reported Event|Phase I: Dose Level -1|Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004114|NCT01075321|EG001|Reported Event|Phase I: Dose Level 0|Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004115|NCT01075321|EG002|Reported Event|Phase I: Dose Level 1|Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004116|NCT01075321|EG003|Reported Event|Phase II: Dose Level 0|Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
11004117|NCT01075347|BG000|Baseline|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
11004118|NCT01075347|BG001|Baseline|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
11004119|NCT01075347|BG002|Baseline|Total|Total of all reporting groups
11004120|NCT01075347|FG000|Participant Flow|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
11004121|NCT01075347|FG001|Participant Flow|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
11004122|NCT01075347|OG000|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
11004123|NCT01075347|OG001|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
11004124|NCT01075347|EG000|Reported Event|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
11004125|NCT01075347|EG001|Reported Event|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
11004126|NCT01075399|BG000|Baseline|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
11004127|NCT01075399|FG000|Participant Flow|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
11004128|NCT01075399|OG000|Outcome|Subjects That Received 1st and 2nd [F18] HX4 Scans|Single arm study. This group includes all subjects that successfully received [F18]HX4 PET scan on 2 separate occasions within 6 days apart to assess reproducibility in measuring tumor hypoxia.
11004129|NCT01075399|EG000|Reported Event|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
11004130|NCT01075412|BG000|Baseline|Group 1|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
11004131|NCT01075412|BG001|Baseline|Group 2|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
11004132|NCT01075412|BG002|Baseline|Total|Total of all reporting groups
11004133|NCT01075412|FG000|Participant Flow|Group 1|"Scheduled to receive the fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy. If no bone marrow uptake is seen at the second or third FLT PET scan, this scan is omitted to reduce radiation risk.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
11004134|NCT01075412|FG001|Participant Flow|Group 2|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. If no bone marrow uptake is seen at the second or third FLT PET scan, this scan is omitted to reduce radiation risk.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
11004135|NCT01075412|OG000|Outcome|All Participants|The outcome measure is evaluated by including study participants from both groups.
11004136|NCT01075412|EG000|Reported Event|Group 1|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
11004137|NCT01075412|EG001|Reported Event|Group 2|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
11004138|NCT01075516|BG000|Baseline|Standard Follow-Up|Implantable cardioverter defibrillators (ICD) patients followed through periodic in-hospital visits
11004139|NCT01075516|BG001|Baseline|Remote Follow-Up|ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
11004140|NCT01075516|BG002|Baseline|Total|Total of all reporting groups
11004141|NCT01075516|FG000|Participant Flow|Standard Follow Up|ICD patients followed through periodic in-hospital visits
11004142|NCT01075516|FG001|Participant Flow|Remote Follow Up|ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
11004143|NCT01075516|OG000|Outcome|Standard Follow Up|ICD patients followed through periodic in-hospital visits
11004144|NCT01075516|OG001|Outcome|Remote Follow Up|ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
11004145|NCT01075516|EG000|Reported Event|Standard Follow Up|ICD patients followed through periodic in-hospital visits
11004146|NCT01075516|EG001|Reported Event|Remote Follow Up|ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
11004147|NCT01075646|BG000|Baseline|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
11004148|NCT01075646|BG001|Baseline|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
11004149|NCT01075646|BG002|Baseline|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
11004150|NCT01075646|BG003|Baseline|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
11004151|NCT01075646|BG004|Baseline|Total|Total of all reporting groups
11004152|NCT01075646|FG000|Participant Flow|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
11004153|NCT01075646|FG001|Participant Flow|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
11102814|NCT01600014|FG000|Participant Flow|Ingenol Mebutate Gel, 0.015% (1st & 2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
11102815|NCT01600014|FG001|Participant Flow|Vehicle Gel (2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with vehicle gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
11102816|NCT01600014|OG000|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
11102817|NCT01600014|OG001|Outcome|Vehicle Gel Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
11102818|NCT01600014|OG002|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
11102819|NCT01600014|OG003|Outcome|Vehicle Gel Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
11102820|NCT01600014|OG000|Outcome|Open Label Only (1st Cycle)|Subjects only treated during 1st cycle (450 participants excluding 203 participants also included in the 2nd cycle)
11102821|NCT01600014|OG001|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
11102822|NCT01600014|OG002|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
11102823|NCT01600014|OG003|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
11102824|NCT01600014|OG004|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
11102825|NCT01600014|OG000|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
11102826|NCT01600014|OG001|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
11102827|NCT01600014|OG002|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
11102828|NCT01600014|OG003|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
11102829|NCT01600014|EG000|Reported Event|Ingenol Mebutate 0.015% Gel (1. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel within a 25 cm2 treatment area on the face or scalp
11102830|NCT01600014|EG001|Reported Event|Ingenol Mebutate 0.015% Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
11102831|NCT01600014|EG002|Reported Event|Vehicle Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with vehicle gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
11102832|NCT01600053|BG000|Baseline|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
11102833|NCT01600053|FG000|Participant Flow|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
11102834|NCT01600053|OG000|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
11102835|NCT01600053|EG000|Reported Event|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
11102836|NCT01600092|BG000|Baseline|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
11102837|NCT01600092|BG001|Baseline|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
11102838|NCT01600092|BG002|Baseline|Total|Total of all reporting groups
11102839|NCT01600092|FG000|Participant Flow|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
11102840|NCT01600092|FG001|Participant Flow|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
11102841|NCT01600092|OG000|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
11102842|NCT01600092|OG001|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
11102843|NCT01600092|EG000|Reported Event|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
11102844|NCT01600092|EG001|Reported Event|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
11102845|NCT01600105|BG000|Baseline|Perfusion MRI|"chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months.~Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents."
11102846|NCT01600105|BG001|Baseline|Healthy Volunteers|Healthy Volunteers in Sub study I only
11102847|NCT01600105|BG002|Baseline|Total|Total of all reporting groups
11102848|NCT01600105|FG000|Participant Flow|Chronic Liver Disease Patients|"chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months.~Sub Study I: Patients were enrolled in the study if they had a liver biopsy performed within 3 months of the MRI study or were diagnosed with liver cirrhosis based on imaging findings.~Sub Study II: Patients with mixed etiology of liver fibrosis proven by biopsy, and/or liver cirrhosis.~Sub study III: Patients with chronic liver disease who underwent invasive hepatic vein pressure gradient (HVPG) measurement"
11102849|NCT01600105|FG001|Participant Flow|Healthy Volunteers|Healthy Volunteer for Sub study I
11102850|NCT01600105|OG000|Outcome|Chronic Hep C Patients|"chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months.~Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents."
11102851|NCT01600105|OG001|Outcome|Healthy Volunteers|No Hep C
11102852|NCT01600105|OG000|Outcome|Perfusion MRI|"chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months.~Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents."
11102853|NCT01600105|EG000|Reported Event|Sub Study 1 Chronic Hep C Patients|Quantitative Liver MRI Combining Phase Contrast Imaging, Elastography, and DWI: Assessment of Reproducibility and Postprandial Effect Description: Patients with liver disease who had portal vein (PV) flow parameters measured with phase contrast (PC) imaging, liver diffusion parameters measured with multiple b value diffusion-weighted imaging (DWI) and liver stiffness (LS) measured with MR elastography (MRE) in fasting conditions and after a meal challenge.
11102854|NCT01600105|EG001|Reported Event|Sub Study 1 Health Volunteers|Quantitative Liver MRI Combining Phase Contrast Imaging, Elastography, and DWI: Assessment of Reproducibility and Postprandial Effect Description: Healthy volunteers who had portal vein (PV) flow parameters measured with phase contrast (PC) imaging, liver diffusion parameters measured with multiple b value diffusion-weighted imaging (DWI) and liver stiffness (LS) measured with MR elastography (MRE) in fasting conditions and after a meal challenge.
11102855|NCT01600105|EG002|Reported Event|Sub Study II|Arm/Group Title: Prospective Comparison of Magnetic Resonance Imaging to Transient Elastography and Serum Markers for Liver Fibrosis Detection Description: Chronic liver disease patients who underwent a multiparametric magnetic resonance imaging (MRI) protocol including diffusion�\weighted imaging (DWI), dynamic contrast�\enhanced (DCE)�\MRI and magnetic resonance elastography (MRE) in comparison with transient elastography (TE) for liver fibrosis detection.
11102856|NCT01600105|EG003|Reported Event|Sub Study III|Noninvasive Prediction of Portal Pressure with MR Elastography and DCE�\MRI of the Liver and Spleen Description: Chronic liver disease patients who underwent HVPG measurement, MR elastography (MRE) and dynamic contrast�\enhanced MRI (DCE�\MRI) of the liver and spleen
11102857|NCT01600105|EG004|Reported Event|Total Participants of the Substudies|Total participants of Sub Study 1, Sub Study II, and Sub Study III
11102858|NCT01600170|BG000|Baseline|Atorvastatin Then Placebo|"Participants were given Atorvastatin followed by a washout period then placebo.~Subjects on PI based HAART regimen were administered atorvastatin at 10mg/day X 2weeks and then 20mg/day for 10 weeks.~Subjects on non-PI / non-NNRTI based HAART regimen were administered 20mg/day X 2weeks and then 40mg/day X 10weeks.~Subjects on NNRTI based HAART regimen were administered 40mg/day X 2weeks and then 80mg/day X 10weeks."
11102859|NCT01600170|BG001|Baseline|Placebo Then Atorvastatin|"Participants were administered Placebo tablets followed by a washout period and then Atorvastatin.~Subjects on PI based HAART regimen were administered atorvastatin at 10mg/day X 2weeks and then 20mg/day for 10 weeks.~Subjects on non-PI / non-NNRTI based HAART regimen were administered 20mg/day X 2weeks and then 40mg/day X 10weeks.~Subjects on NNRTI based HAART regimen were administered 40mg/day X 2weeks and then 80mg/day X 10weeks."
11102860|NCT01600170|BG002|Baseline|Total|Total of all reporting groups
11102861|NCT01600170|FG000|Participant Flow|Atorvastatin, Then Placebo|Participants were assigned atorvastatin at different conc. (20, 40 or 60mg / day) based on HAART for 12 wks. After a washout period of 4 weeks participants received placebo tablets (matching atorvastatin), for 12 weeks followed by another washout period of 4 weeks.
11102862|NCT01600170|FG001|Participant Flow|Placebo, Then Atorvastatin|Participants were assigned placebo tablets for 12 wks. After a washout period of 4 weeks participants received atorvastatin tablets at different conc.(20, 40 or 60mg / day) based on HAART, for 12 weeks followed by another washout period of 4 weeks.
11102863|NCT01600170|OG000|Outcome|Atorvastatin|"Participants were given Atorvastatin depending on their HAART~Subjects on PI based HAART regimen were administered atorvastatin at 10mg/day X 2weeks and then 20mg/day for 10 weeks.~Subjects on non-PI / non-NNRTI based HAART regimen were administered 20mg/day X 2weeks and then 40mg/day X 10weeks.~Subjects on NNRTI based HAART regimen were administered 40mg/day X 2weeks and then 80mg/day X 10weeks."
11102864|NCT01600170|OG001|Outcome|Placebo|Participants were administered Placebo tablets for 12 weeks.
11102865|NCT01600170|OG000|Outcome|Atorvastatin|"Participants were given Atorvastatin based on their HAART~Subjects on PI based HAART regimen were administered atorvastatin at 10mg/day X 2weeks and then 20mg/day for 10 weeks.~Subjects on non-PI / non-NNRTI based HAART regimen were administered 20mg/day X 2weeks and then 40mg/day X 10weeks.~Subjects on NNRTI based HAART regimen were administered 40mg/day X 2weeks and then 80mg/day X 10weeks."
11102866|NCT01600170|OG001|Outcome|Placebo|Participants were administered Placebo tablets for 12 weeks
11102867|NCT01600170|EG000|Reported Event|Atorvastatin|"Participants were given Atorvastatin for 12 weeks based on HAART~Subjects on PI based HAART regimen were administered atorvastatin at 10mg/day X 2weeks and then 20mg/day for 10 weeks.~Subjects on non-PI / non-NNRTI based HAART regimen were administered 20mg/day X 2weeks and then 40mg/day X 10weeks.~Subjects on NNRTI based HAART regimen were administered 40mg/day X 2weeks and then 80mg/day X 10weeks."
11102868|NCT01600170|EG001|Reported Event|Placebo|Participants were administered Placebo tablets for 12 weeks.
11102869|NCT01600222|BG000|Baseline|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
11102870|NCT01600222|FG000|Participant Flow|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
11102871|NCT01600222|OG000|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
11102872|NCT01600222|OG000|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
11102873|NCT01600222|EG000|Reported Event|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
11102874|NCT01600287|BG000|Baseline|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
11102875|NCT01600287|BG001|Baseline|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
11102876|NCT01600287|BG002|Baseline|Total|Total of all reporting groups
11102877|NCT01600287|FG000|Participant Flow|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
11102878|NCT01600287|FG001|Participant Flow|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
11102879|NCT01600287|OG000|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
11102880|NCT01600287|OG001|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
11102881|NCT01600287|EG000|Reported Event|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
11102882|NCT01600287|EG001|Reported Event|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
11102883|NCT01600326|BG000|Baseline|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
11126475|NCT01733472|OG000|Outcome|RA-arm|"RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg~RA-arm: Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5."
11126476|NCT01733472|EG000|Reported Event|RA-arm|"RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg~placebo"
11102884|NCT01600326|BG001|Baseline|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
11102885|NCT01600326|BG002|Baseline|Total|Total of all reporting groups
11102886|NCT01600326|FG000|Participant Flow|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
11102887|NCT01600326|FG001|Participant Flow|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
11102888|NCT01600326|OG000|Outcome|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
11102889|NCT01600326|OG001|Outcome|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
11102890|NCT01600326|EG000|Reported Event|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
11102891|NCT01600326|EG001|Reported Event|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
11102892|NCT01600482|BG000|Baseline|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
11102893|NCT01600482|BG001|Baseline|Manual Compression|Manual Compression
11102894|NCT01600482|BG002|Baseline|Total|Total of all reporting groups
11102895|NCT01600482|FG000|Participant Flow|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
11102896|NCT01600482|FG001|Participant Flow|Manual Compression|Manual Compression
11102897|NCT01600482|OG000|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
11102898|NCT01600482|OG001|Outcome|Manual Compression|Manual Compression
11102899|NCT01600482|EG000|Reported Event|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
11102900|NCT01600482|EG001|Reported Event|Manual Compression|Manual Compression
11102901|NCT01600495|BG000|Baseline|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
11102902|NCT01600495|BG001|Baseline|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
11102903|NCT01600495|BG002|Baseline|Total|Total of all reporting groups
11102904|NCT01600495|FG000|Participant Flow|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
11102905|NCT01600495|FG001|Participant Flow|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
11102906|NCT01600495|OG000|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
11102907|NCT01600495|OG001|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
11102908|NCT01600495|OG000|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
11102909|NCT01600495|EG000|Reported Event|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
11102910|NCT01600495|EG001|Reported Event|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
11102911|NCT01600586|BG000|Baseline|Books, PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL).~Infants were randomly assigned by using a block system to control or intervention groups. Eligible siblings were enrolled into the same group because they shared the same room in the NICU. If 1 child received the PAM intervention while the other engaged in NNS, diffusion of treatment might occur; removal of the siblings' pacifier during the pacifier-activated lullaby (PAL) was not an alternative acceptable to nursing staff."
11102912|NCT01600586|BG001|Baseline|Books, No PAL Group|No PAL
11102913|NCT01600586|BG002|Baseline|Total|Total of all reporting groups
11102914|NCT01600586|FG000|Participant Flow|Books, PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL)."
11102915|NCT01600586|FG001|Participant Flow|Books, No PAL Group|"No PAL~At enrollment, all mother-infant dyads received a set of 4 well-known children's books, 2 of which were single-story songbooks. Mothers in both groups were encouraged to read and sing to their infants whenever they were present; no time quota, schedule, or log was provided. Mothers were informed that the study's objective was to evaluate the influence of their voice on their infant's feeding ability."
11102916|NCT01600586|OG000|Outcome|PAL Intervention|This group of participants received PAL intervention
11102917|NCT01600586|OG001|Outcome|No PAL Intervention|This group of participants did not receive PAL intervention
11102918|NCT01600586|OG000|Outcome|This is the PAL Intervention|This group received intervention
11102919|NCT01600586|OG001|Outcome|No PAL|This group received no PAL intervention
11102920|NCT01600586|OG000|Outcome|This is the PAL Intervention Group|This is the PAL intervention group
11102921|NCT01600586|OG001|Outcome|This is the NO PAL Group|This is the NO PAL group
11102922|NCT01600586|OG000|Outcome|Books, PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL)."
11102923|NCT01600586|OG001|Outcome|Books, No PAL Group|No PAL
11102924|NCT01600586|OG001|Outcome|Books, No PAL Group|"No PAL~At enrollment, all mother-infant dyads received a set of 4 well-known children's books, 2 of which were single-story songbooks. Mothers in both groups were encouraged to read and sing to their infants whenever they were present; no time quota, schedule, or log was provided. Mothers were informed that the study's objective was to evaluate the influence of their voice on their infant's feeding ability."
11102925|NCT01600586|EG000|Reported Event|PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL)."
11102926|NCT01600586|EG001|Reported Event|Books, No PAL Group|No PAL
11102927|NCT01600638|BG000|Baseline|Zeltiq System Treatment Group|"All subjects treated with the Zeltiq System are included in the treatment arm.~The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration."
11102928|NCT01600638|FG000|Participant Flow|Zeltiq System Treatment Group|"All subjects treated with the Zeltiq System are included in the treatment arm.~The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration."
11102929|NCT01600638|OG000|Outcome|Zeltiq System Treatment Group|"All subjects treated with the Zeltiq System are included in the treatment arm.~The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration."
11102930|NCT01600638|EG000|Reported Event|Zeltiq System Treatment Group|"All subjects treated with the Zeltiq System are included in the treatment arm.~The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration."
11102931|NCT01600677|BG000|Baseline|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
11102932|NCT01600677|BG001|Baseline|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
11102933|NCT01600677|BG002|Baseline|Total|Total of all reporting groups
11102934|NCT01600677|FG000|Participant Flow|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
11102935|NCT01600677|FG001|Participant Flow|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
11102936|NCT01600677|OG000|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
11102937|NCT01600677|OG001|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
11102938|NCT01600677|EG000|Reported Event|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
11102939|NCT01600677|EG001|Reported Event|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
11102940|NCT01600703|BG000|Baseline|All Study Participants|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
11102941|NCT01600703|FG000|Participant Flow|Placebo First, Then Sitagliptin|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
11102942|NCT01600703|FG001|Participant Flow|Sitagliptin First, Then Placebo|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
11102943|NCT01600703|OG000|Outcome|Placebo|placebo, oral, single dose
11102944|NCT01600703|OG001|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
11102945|NCT01600703|EG000|Reported Event|Placebo|placebo, oral, single dose
11102946|NCT01600703|EG001|Reported Event|Sitagliptin|sitagliptin, 100mg, oral, single dose
11102947|NCT01600716|BG000|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
10846733|NCT00279500|EG000|Reported Event|Argus 16 Retinal Stimulation System|Single arm study in which all patients receive a device to stimulate retinal (eye) cells. The treatment is intended to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.
11102948|NCT01600716|BG001|Baseline|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
11102949|NCT01600716|BG002|Baseline|Total|Total of all reporting groups
11102950|NCT01600716|FG000|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
11102951|NCT01600716|FG001|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
11102952|NCT01600716|OG000|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
11102953|NCT01600716|OG001|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
11102954|NCT01600716|EG000|Reported Event|OnabotulinumtoxinA Treatment Cycle 1|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. Median duration of exposure is 50.7 weeks.
11102955|NCT01600716|EG001|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. Median duration of exposure is 15.2 weeks.
11102956|NCT01600716|EG002|Reported Event|OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, a second onabotulinumtoxinA injection is given. Median duration of exposure is 12.5 weeks.
11102957|NCT01600716|EG003|Reported Event|Placebo (Normal Saline)/OnabotulinumtoxinA|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, an onabotulinumtoxinA injection is given. Median duration of exposure is 12.2 weeks.
11102958|NCT01600729|BG000|Baseline|All Participants|Participants with facial lines. There was no intervention in this study.
11102959|NCT01600729|FG000|Participant Flow|All Participants|Participants with facial lines. There was no intervention in this study.
11102960|NCT01600729|OG000|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
11102961|NCT01600729|EG000|Reported Event|All Participants|Participants with facial lines. There was no intervention in this study.
11102962|NCT01600885|BG000|Baseline|Overall Study|This 'arm' consists of all study participants who started the first Study Period. This Study Period consisted of an initial screening visit in which it was determined whether participants met the inclusion/exclusion criteria for further participation in this study.
11102963|NCT01600885|FG000|Participant Flow|Guanfacine Then Placebo|"During the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI.~Guanfacine then Placebo: During the first study session, the patient will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.~The second study session will be identical except that the patient will be given a placebo instead of the guanfacine."
11102964|NCT01600885|FG001|Participant Flow|Placebo Then Guanfacine|"During the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI.~Placebo then Guanfacine: During the first study session, the patient will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.~The second study session will be identical except that the patient will be given 3mg of guanfacine instead of the placebo."
11102965|NCT01600885|OG000|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
11102966|NCT01600885|OG001|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
11102967|NCT01600885|EG000|Reported Event|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
11102968|NCT01600885|EG001|Reported Event|Placebo|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
11102969|NCT01600950|BG000|Baseline|All Participants|A single 0.3 units/kilogram (U/kg) dose of either LY2963016 or LANTUS was administered subcutaneously on Day 1 of Periods 1 or 2.
11102970|NCT01600950|FG000|Participant Flow|LY2963016/Lantus|"A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.~A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 2."
11102971|NCT01600950|FG001|Participant Flow|Lantus/LY2963016|"A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.~A single 0.3 U/kg dose of LY2963016 was administered subcutaneously on Day 1 during Period 2."
11102972|NCT01600950|OG000|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
11102973|NCT01600950|OG001|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
11102974|NCT01600950|EG000|Reported Event|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
11102975|NCT01600950|EG001|Reported Event|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
11126477|NCT01733472|EG001|Reported Event|GA-arm, Remifentanil|"GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol~GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the Marsh and Minto algorithm"
10846734|NCT00279591|BG000|Baseline|Control Group|Oscillometric Blood Pressure Monitoring
11102976|NCT01601067|BG000|Baseline|Arm 1: Integrated Prolonged Exposure Therapy|"Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)~Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma."
11102977|NCT01601067|BG001|Baseline|Arm 2: Seeking Safety|"Seeking Safety~Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance."
11102978|NCT01601067|BG002|Baseline|Total|Total of all reporting groups
11102979|NCT01601067|FG000|Participant Flow|Arm 1: Integrated Prolonged Exposure Therapy|"Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)~Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma."
11102980|NCT01601067|FG001|Participant Flow|Arm 2: Seeking Safety|"Seeking Safety~Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance."
11102981|NCT01601067|OG000|Outcome|Arm 1: Integrated Prolonged Exposure Therapy|"Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)~Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma."
11102982|NCT01601067|OG001|Outcome|Arm 2: Seeking Safety|"Seeking Safety~Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance."
11102983|NCT01601067|EG000|Reported Event|Arm 1: Integrated Prolonged Exposure Therapy|"Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)~Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma."
11102984|NCT01601067|EG001|Reported Event|Arm 2: Seeking Safety|"Seeking Safety~Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance."
11102985|NCT01601132|BG000|Baseline|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5-18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
11102986|NCT01601132|FG000|Participant Flow|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5-18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
11102987|NCT01601132|OG000|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
11102988|NCT01601132|OG001|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
11102989|NCT01601132|EG000|Reported Event|Theophylline|Theophylline 300 mg, solution, orally, on Day 1, followed by a 4-day washout period.
11102990|NCT01601132|EG001|Reported Event|Colchicine|Colchicine, 0.6 mg tablet, orally, twice daily, from Days 5-18.
11102991|NCT01601132|EG002|Reported Event|Colchicine + Theophylline|Theophylline 300 mg, solution, orally, single dose and colchicine 0.6 mg, tablets, orally, twice daily, on Day 19.
11102992|NCT01601236|BG000|Baseline|Group 1: Acthar 8 U (0.1 mL) Daily|"Repository Corticotropin Injection~Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
11102993|NCT01601236|BG001|Baseline|Group 2: Placebo (0.1 mL) Daily|"Placebo~Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
11102994|NCT01601236|BG002|Baseline|Group 3: Acthar 16 U (0.2 mL) Daily|"Repository Corticotropin Injection~Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
11102995|NCT01601236|BG003|Baseline|Group 4: Placebo (0.2 mL) Daily|"Placebo~Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
11102996|NCT01601236|BG004|Baseline|Group 5: Acthar 32 U (0.4 mL) Daily|"Repository Corticotropin Injection~Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
11102997|NCT01601236|BG005|Baseline|Group 6: Placebo (0.4 mL) Daily|"Placebo~Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
11102998|NCT01601236|BG006|Baseline|Total|Total of all reporting groups
11102999|NCT01601236|FG000|Participant Flow|Group 1: Acthar 8 U (0.1 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily subcutaneous (SC) injection for 36 weeks
11103000|NCT01601236|FG001|Participant Flow|Group 2: Placebo (0.1 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API)administered via daily SC injection for 36 weeks
11103001|NCT01601236|FG002|Participant Flow|Group 3: Acthar 16 U (0.2 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily SC injection for 36 weeks
11103002|NCT01601236|FG003|Participant Flow|Group 4: Placebo (0.2 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the API administered via daily SC injection for 36 weeks
11103003|NCT01601236|FG004|Participant Flow|Group 5: Acthar 32 U (0.4 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily SC injection for 36 weeks
11103004|NCT01601236|FG005|Participant Flow|Group 6: Placebo (0.4 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the API administered via daily SC injection for 36 weeks
11103005|NCT01601236|OG000|Outcome|Placebo|Groups 2, 4, 6
11103006|NCT01601236|OG001|Outcome|Acthar 8 Units|Group 1
11103007|NCT01601236|OG002|Outcome|Acthar 16 Units|Groups 3, 5
11103008|NCT01601236|EG000|Reported Event|Placebo|Groups 2, 4, 6
11103009|NCT01601236|EG001|Reported Event|Acthar 8 Units|Group 1
11103010|NCT01601236|EG002|Reported Event|Acthar 16 Units|Groups 3, 5; This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3). Thus, Adverse Events were not collected separately for these Arms.
11103011|NCT01601236|EG003|Reported Event|Overall|Groups 1, 2, 3, 4, 5, 6
11103012|NCT01601431|BG000|Baseline|Cap Assisted Colonoscopy|"Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.~Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate"
11103013|NCT01601431|BG001|Baseline|Conventional Colonoscopy|"A conventional colonoscopy does not use a Cap in order to perform the procedure~Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate~Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines"
11103014|NCT01601431|BG002|Baseline|Total|Total of all reporting groups
11103015|NCT01601431|FG000|Participant Flow|Cap Assisted Colonoscopy|"Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.~Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate"
11103016|NCT01601431|FG001|Participant Flow|Conventional Colonoscopy|A conventional colonoscopy does not use a Cap in order to perform the procedure
11103017|NCT01601431|OG000|Outcome|Cap Assisted Colonoscopy|"Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.~Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate"
11103018|NCT01601431|OG001|Outcome|Conventional Colonoscopy|"A conventional colonoscopy does not use a Cap in order to perform the procedure~Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate~Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines"
11103019|NCT01601431|EG000|Reported Event|Cap Assisted Colonoscopy|"Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.~Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate"
11103020|NCT01601431|EG001|Reported Event|Conventional Colonoscopy|"A conventional colonoscopy does not use a Cap in order to perform the procedure~Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate~Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines"
11103021|NCT01601470|BG000|Baseline|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
11103022|NCT01601470|FG000|Participant Flow|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
11103023|NCT01601470|OG000|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
11103024|NCT01601470|EG000|Reported Event|Period 1: Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by wash out on Day 2.
11103025|NCT01601470|EG001|Reported Event|Period 2: LCZ696|In Period 2 (study Days 3-7), participants received LCZ696 once daily.
11103026|NCT01601470|EG002|Reported Event|Period 3: LCZ696 + Sildenafil|In Period 3, on study Day 8, participants received LCZ696 , co-administered at the same time with a single dose of sildenafil.
11103027|NCT01601496|BG000|Baseline|FUSION Vascular Graft|All subjects who received a FUSION Vascular Graft at the baseline implant procedure
11103028|NCT01601496|FG000|Participant Flow|FUSION Vascular Graft|All subjects who received a FUSION Vascular Graft at the baseline implant procedure
11103029|NCT01601496|OG000|Outcome|FUSION Vascular Graft|All subjects who received a FUSION Vascular Graft at the baseline implant procedure
11103030|NCT01601496|EG000|Reported Event|FUSION Vascular Graft|All subjects who receive a FUSION Vascular Graft at the baseline implant procedure
11103031|NCT01601535|BG000|Baseline|DL 1|alisertib tablets (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional
11103032|NCT01601535|BG001|Baseline|DL 1B|alisertib tablets (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103033|NCT01601535|BG002|Baseline|DL 2B|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103034|NCT01601535|BG003|Baseline|DL 3B|alisertib tablets (80 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103035|NCT01601535|BG004|Baseline|Ph 2|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103036|NCT01601535|BG005|Baseline|Oral Solution|alisertib oral solution (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103037|NCT01601535|BG006|Baseline|Total|Total of all reporting groups
11103038|NCT01601535|FG000|Participant Flow|DL 1|alisertib tablets (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional
11103039|NCT01601535|FG001|Participant Flow|DL 1B|alisertib tablets (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103040|NCT01601535|FG002|Participant Flow|DL 2B|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103041|NCT01601535|FG003|Participant Flow|DL 3B|alisertib tablets (80 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103042|NCT01601535|FG004|Participant Flow|Ph 2|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103043|NCT01601535|FG005|Participant Flow|Oral Solution|alisertib oral solution (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103044|NCT01601535|OG000|Outcome|Phase I|Patients received alisertib tablets at dose levels of 45, 60, and 80 mg/m^2 per day on days 1 to 7 along with irinotecan 50 mg/m^2 intravenously and temozolomide 100 mg/m^2 orally on days 1 to 5.
11103045|NCT01601535|OG000|Outcome|DL 1|alisertib tablets (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional
11103046|NCT01601535|OG001|Outcome|DL 1B|alisertib tablets (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103047|NCT01601535|OG002|Outcome|DL 2B|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103048|NCT01601535|OG003|Outcome|DL 3B|alisertib tablets (80 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103049|NCT01601535|OG004|Outcome|Oral Solution|alisertib oral solution (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103050|NCT01601535|OG004|Outcome|Ph 2|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103051|NCT01601535|OG005|Outcome|Oral Solution|alisertib oral solution (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103052|NCT01601535|OG000|Outcome|Ph 2|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103053|NCT01601535|OG000|Outcome|Objective Responders|Consisting of complete response (CR), CR with minimal residual disease (CR-MRD), and partial response (PR).
10846735|NCT00279591|BG001|Baseline|Intervention Group|Near Continuous Blood Pressure Monitoring
11103054|NCT01601535|OG001|Outcome|Objective Non-Responders|Consisting of minor response (MR), stable disease (SD) and progressive disease (PD).
11103055|NCT01601535|OG000|Outcome|First Cycle DLT Yes|Patients who had DLT in the first cycle of treatment.
11103056|NCT01601535|OG001|Outcome|First Cycle DLT No|Patients who did not have DLT in the first cycle of treatment.
11103057|NCT01601535|OG002|Outcome|DLT in Any Cycle Yes|Patients who had DLT in any cycle of treatment.
11103058|NCT01601535|OG003|Outcome|DLT in Any Cycle No|Patients who did not have DLT in any cycle of treatment.
11103059|NCT01601535|EG000|Reported Event|DL 1|alisertib tablets (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional
11103060|NCT01601535|EG001|Reported Event|DL 1B|alisertib tablets (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103061|NCT01601535|EG002|Reported Event|DL 2B|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103062|NCT01601535|EG003|Reported Event|DL 3B|alisertib tablets (80 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103063|NCT01601535|EG004|Reported Event|Ph 2|alisertib tablets (60 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11004154|NCT01075646|FG002|Participant Flow|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
11004155|NCT01075646|FG003|Participant Flow|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
11004156|NCT01075646|OG000|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
11004157|NCT01075646|OG001|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
11004158|NCT01075646|OG002|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
11004159|NCT01075646|OG003|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
11004160|NCT01075646|EG000|Reported Event|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
11004161|NCT01075646|EG001|Reported Event|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
11004162|NCT01075646|EG002|Reported Event|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
11004163|NCT01075646|EG003|Reported Event|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
11004164|NCT01075685|BG000|Baseline|Web-based Alcohol Programme|
11004165|NCT01075685|BG001|Baseline|Minimum Information|
11004166|NCT01075685|BG002|Baseline|Total|Total of all reporting groups
11004167|NCT01075685|FG000|Participant Flow|Web-based Alcohol Programme|
11004168|NCT01075685|FG001|Participant Flow|Minimum Information|
11004169|NCT01075685|OG000|Outcome|Web-based Alcohol Programme|
11004170|NCT01075685|OG001|Outcome|Minimum Information|
11004171|NCT01075685|EG000|Reported Event|Web-based Alcohol Programme|
11004172|NCT01075685|EG001|Reported Event|Minimum Information|
10846736|NCT00279591|BG002|Baseline|Total|Total of all reporting groups
10846737|NCT00279591|FG000|Participant Flow|Control Group|Oscillometric Blood Pressure Monitoring
11004173|NCT01075763|BG000|Baseline|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
11004174|NCT01075763|BG001|Baseline|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
11004175|NCT01075763|BG002|Baseline|Total|Total of all reporting groups
11004176|NCT01075763|FG000|Participant Flow|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
11004177|NCT01075763|FG001|Participant Flow|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
11004178|NCT01075763|OG000|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
11004179|NCT01075763|OG001|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
11004180|NCT01075763|EG000|Reported Event|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
11004181|NCT01075763|EG001|Reported Event|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
11103064|NCT01601535|EG005|Reported Event|Oral Solution|alisertib oral solution (45 mg/m^2/dose x 7 days), irinotecan (50 mg/m^2/dose IV x 5 days), temozolomide (100 mg/m^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required
11103065|NCT01601626|BG000|Baseline|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
11103066|NCT01601626|BG001|Baseline|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
11103067|NCT01601626|BG002|Baseline|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
11103068|NCT01601626|BG003|Baseline|Total|Total of all reporting groups
11103069|NCT01601626|FG000|Participant Flow|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
11103070|NCT01601626|FG001|Participant Flow|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
11103071|NCT01601626|FG002|Participant Flow|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
11103072|NCT01601626|OG000|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
11103073|NCT01601626|OG001|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
11103074|NCT01601626|OG002|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
11103075|NCT01601626|EG000|Reported Event|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
11103076|NCT01601626|EG001|Reported Event|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
11103077|NCT01601626|EG002|Reported Event|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
11103078|NCT01601652|BG000|Baseline|Omeagven|Omegaven: 1 g/kg/d iv infusion over 24h
11103079|NCT01601652|FG000|Participant Flow|Omeagven|Omegaven: 1 g/kg/d iv infusion over 24h
11103080|NCT01601652|OG000|Outcome|Omeagven|Omegaven: 1 g/kg/d iv infusion over 24h
11103081|NCT01601652|EG000|Reported Event|Omeagven|Omegaven: 1 g/kg/d iv infusion over 24h
11103082|NCT01601691|BG000|Baseline|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
11103083|NCT01601691|FG000|Participant Flow|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
11103084|NCT01601691|OG000|Outcome|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
11103085|NCT01601691|EG000|Reported Event|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
11103086|NCT01601704|BG000|Baseline|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
11103087|NCT01601704|BG001|Baseline|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
11103088|NCT01601704|BG002|Baseline|Total|Total of all reporting groups
11103089|NCT01601704|FG000|Participant Flow|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
10846738|NCT00279591|FG001|Participant Flow|Intervention Group|Near Continuous Blood Pressure Monitoring
10846739|NCT00279591|OG000|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
10846740|NCT00279591|OG001|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
11103090|NCT01601704|FG001|Participant Flow|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
11103091|NCT01601704|OG000|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
11103092|NCT01601704|OG001|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
11103093|NCT01601704|EG000|Reported Event|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
11103094|NCT01601704|EG001|Reported Event|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
11103095|NCT01601782|BG000|Baseline|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
11103096|NCT01601782|FG000|Participant Flow|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
11103097|NCT01601782|OG000|Outcome|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
11103098|NCT01601782|EG000|Reported Event|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
11103099|NCT01601821|BG000|Baseline|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
11103100|NCT01601821|BG001|Baseline|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
11103101|NCT01601821|BG002|Baseline|Total|Total of all reporting groups
11103102|NCT01601821|FG000|Participant Flow|CsA+Rapamune+CS|Month 0-3: rapamune 6 milligram (mg) tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 nanogram per milliliter (ng/mL) in combination with cyclosporine (CsA) tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, mycophenolate mofetil (MMF) tablet orally at a dose of 1-1.5 grams per day (g/day) and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received corticosteroids (CS) tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
11103103|NCT01601821|FG001|Participant Flow|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
11103104|NCT01601821|OG000|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
11103105|NCT01601821|OG001|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
11103106|NCT01601821|EG000|Reported Event|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
11103107|NCT01601821|EG001|Reported Event|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
11103108|NCT01601847|BG000|Baseline|Sustained|"Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake~Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity.~Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study."
11103109|NCT01601847|BG001|Baseline|Diet-Limited|"Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day~Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity.~Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study."
11103110|NCT01601847|BG002|Baseline|Total|Total of all reporting groups
11103111|NCT01601847|FG000|Participant Flow|Sustained|"Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake~Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity.~Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study."
11103112|NCT01601847|FG001|Participant Flow|Diet-Limited|"Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day~Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity.~Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study."
11103113|NCT01601847|OG000|Outcome|Sustained|"Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake~Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity.~Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study."
11103114|NCT01601847|OG001|Outcome|Diet-Limited|"Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day~Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity.~Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study."
11103115|NCT01601847|EG000|Reported Event|Sustained|"Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake~Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity.~Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study."
11103116|NCT01601847|EG001|Reported Event|Diet-Limited|"Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day~Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity.~Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study."
11103117|NCT01601860|BG000|Baseline|Control|"Active Comparator: Control Group Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.~Other: Routine care: Other: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient."
11103118|NCT01601860|BG001|Baseline|Intervention Group|"Experimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation> 7 cm);~Use of non-pharmacological: Other: Non-pharmacological resources~A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:~Walking (with cervical dilation between 4 and 5 cm)~Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)~Shower (with dilation> 7 cm);"
11103119|NCT01601860|BG002|Baseline|Total|Total of all reporting groups
11004182|NCT01075815|BG000|Baseline|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
11004183|NCT01075815|BG001|Baseline|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
11004184|NCT01075815|BG002|Baseline|Total|Total of all reporting groups
11004185|NCT01075815|FG000|Participant Flow|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
11004186|NCT01075815|FG001|Participant Flow|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
11004187|NCT01075815|OG000|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
11004188|NCT01075815|OG001|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
11004189|NCT01075815|EG000|Reported Event|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
11004190|NCT01075815|EG001|Reported Event|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
11004191|NCT01075958|BG000|Baseline|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
11004192|NCT01075958|FG000|Participant Flow|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
11004193|NCT01075958|OG000|Outcome|Healthy Participants|All eligible participants.
11004194|NCT01075958|EG000|Reported Event|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
11004195|NCT01075971|BG000|Baseline|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
11004196|NCT01075971|FG000|Participant Flow|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
11004197|NCT01075971|OG000|Outcome|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
11004198|NCT01075971|EG000|Reported Event|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
11004199|NCT01075984|BG000|Baseline|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
11004200|NCT01075984|BG001|Baseline|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
11004201|NCT01075984|BG002|Baseline|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
11004202|NCT01075984|BG003|Baseline|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
11004203|NCT01075984|BG004|Baseline|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
11004204|NCT01075984|BG005|Baseline|Total|Total of all reporting groups
11004205|NCT01075984|FG000|Participant Flow|Posaconazole (POS) 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
11004206|NCT01075984|FG001|Participant Flow|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
11004207|NCT01075984|FG002|Participant Flow|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
11004208|NCT01075984|FG003|Participant Flow|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
11004209|NCT01075984|FG004|Participant Flow|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
11103120|NCT01601860|FG000|Participant Flow|Intervention Group|"Experimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation> 7 cm);~Use of non-pharmacological: Other: Non-pharmacological resources~A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:~Walking (with cervical dilation between 4 and 5 cm)~Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)~Shower (with dilation> 7 cm);"
11103121|NCT01601860|FG001|Participant Flow|Control|"Active Comparator: Control Group Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.~Other: Routine care: Other: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient."
11103122|NCT01601860|OG000|Outcome|Control Group|"Active Comparator: Control Group Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.~Other: Routine care: Other: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient."
11103123|NCT01601860|OG001|Outcome|Intervention Group|"Experimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation> 7 cm);~Use of non-pharmacological: Other: Non-pharmacological resources~A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:~Walking (with cervical dilation between 4 and 5 cm)~Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)~Shower (with dilation> 7 cm)."
11103124|NCT01601860|OG000|Outcome|Control|The moment in centimeters that women requested analgesia during the active phase of childbirth, analyzed by cevical dilation.
11103125|NCT01601860|EG000|Reported Event|Intervention Group|"Experimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation> 7 cm);~Use of non-pharmacological: Other: Non-pharmacological resources~A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:~Walking (with cervical dilation between 4 and 5 cm)~Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)~Shower (with dilation> 7 cm);"
11103126|NCT01601860|EG001|Reported Event|Control|"Active Comparator: Control Group Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.~Other: Routine care: Other: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient."
11103127|NCT01601873|BG000|Baseline|PROPATEN|"patients with heparin-bonded graft implantation~PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access"
11103128|NCT01601873|BG001|Baseline|Standard Graft|"patients undergoing ePTFE hemodialysis graft implantation~Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft"
11103129|NCT01601873|BG002|Baseline|Total|Total of all reporting groups
11103130|NCT01601873|FG000|Participant Flow|PROPATEN|"patients with heparin-bonded graft implantation~PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access"
11103131|NCT01601873|FG001|Participant Flow|Standard Graft|"patients undergoing ePTFE hemodialysis graft implantation~Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft"
11103132|NCT01601873|OG000|Outcome|PROPATEN|"patients with heparin-bonded graft implantation~PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access"
11103133|NCT01601873|OG001|Outcome|Standard Graft|"patients undergoing ePTFE hemodialysis graft implantation~Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft"
11103134|NCT01601873|EG000|Reported Event|PROPATEN|"patients with heparin-bonded graft implantation~PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access"
11103135|NCT01601873|EG001|Reported Event|Standard Graft|"patients undergoing ePTFE hemodialysis graft implantation~Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft"
11103136|NCT01601977|BG000|Baseline|All Participants|Single arm crossover nonrandomised study
11103137|NCT01601977|FG000|Participant Flow|All Study Participants|Initial study period in usual care then switched to novel ventilation with AVAPS-AE algorithm
11103138|NCT01601977|OG000|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
11103139|NCT01601977|OG001|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
11103140|NCT01601977|EG000|Reported Event|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
11103141|NCT01601977|EG001|Reported Event|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care"
11103142|NCT01602068|BG000|Baseline|Dexamethasone Phosphate Ophthalmic|Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
11103143|NCT01602068|BG001|Baseline|100 mM Sodium Citrate Buffer|Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
11103144|NCT01602068|BG002|Baseline|Total|Total of all reporting groups
11103145|NCT01602068|FG000|Participant Flow|Dexamethasone Phosphate Ophthalmic|Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
11103146|NCT01602068|FG001|Participant Flow|100 mM Sodium Citrate Buffer|Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
11103147|NCT01602068|OG000|Outcome|Dexamethasone Phosphate Ophthalmic|Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
11103148|NCT01602068|OG001|Outcome|100 mM Sodium Citrate Buffer|Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
11103149|NCT01602068|EG000|Reported Event|Dexamethasone Phosphate Ophthalmic|Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
11103150|NCT01602068|EG001|Reported Event|100 mM Sodium Citrate Buffer|Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
11103151|NCT01602120|BG000|Baseline|CFD4870g Sham|Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.
11103152|NCT01602120|BG001|Baseline|CFD4870g Lampalizumab|Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.
11103153|NCT01602120|BG002|Baseline|GX29455 Sham|Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
11103154|NCT01602120|BG003|Baseline|GX29455 Lampalizumab|Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
11103155|NCT01602120|BG004|Baseline|Total|Total of all reporting groups
11103156|NCT01602120|FG000|Participant Flow|CFD4870g Sham|Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.
11103157|NCT01602120|FG001|Participant Flow|CFD4870g Lampalizumab|Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.
11103158|NCT01602120|FG002|Participant Flow|GX29455 Sham|Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
11103159|NCT01602120|FG003|Participant Flow|GX29455 Lampalizumab|Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
11103160|NCT01602120|OG000|Outcome|CFD4870g Sham|Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.
11103161|NCT01602120|OG001|Outcome|CFD4870g Lampalizumab|Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.
11103162|NCT01602120|OG002|Outcome|GX29455 Sham|Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
11103163|NCT01602120|OG003|Outcome|GX29455 Lampalizumab|Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
11103164|NCT01602120|OG004|Outcome|All Participants|All participants in the study received lampalizumab 10 mg, ITV, Q4W.
11103165|NCT01602120|EG000|Reported Event|CFD4870g Sham|Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.
11103166|NCT01602120|EG001|Reported Event|CFD4870g Lampalizumab|Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.
11103167|NCT01602120|EG002|Reported Event|GX29455 Sham|Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
11103168|NCT01602120|EG003|Reported Event|GX29455 Lampalizumab|Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
11103169|NCT01602120|EG004|Reported Event|All Participants|All participants in the study received lampalizumab 10 mg, ITV, Q4W.
11103170|NCT01602172|BG000|Baseline|Brief Alcohol Intervention (BI)|"Brief Intervention Condition--3 part motivational discussion in and out of hospital~Brief Alcohol Intervention: 3 part intervention: Part I is 15-minute multi-component motivational discussion in hospital which includes personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II is 15-minute follow-up in hospital to reinforce Part I. Part III is 15-minute follow-up telephone call at 2 weeks to reinforce Part I."
11103171|NCT01602172|BG001|Baseline|Attention Control|"Traditional Attention Control Condition~Lifestyle brochures: Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have."
11103172|NCT01602172|BG002|Baseline|Control|"Attention Control, Limited Assessment~Lifestyle brochures: Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have."
11103173|NCT01602172|BG003|Baseline|Total|Total of all reporting groups
11103174|NCT01602172|FG000|Participant Flow|Brief Alcohol Intervention (BI)|"Brief Intervention Condition--3 part motivational discussion in and out of hospital~Brief Alcohol Intervention: 3 part intervention: Part I was a 15-minute multi-component motivational discussion in hospital which included personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II was a 15-minute follow-up in hospital to reinforce Part I. Part III was 15-minute follow-up telephone call at 2 weeks to reinforce Part I."
11103175|NCT01602172|FG001|Participant Flow|Attention Control|"Traditional Attention Control Condition~Lifestyle brochures: Set of educational brochures/brochures which contained information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant called patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) had."
11103176|NCT01602172|FG002|Participant Flow|Control|"Attention Control, Limited Assessment~Lifestyle brochures: Set of educational brochures/brochures which contained information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant called patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) had."
11103177|NCT01602172|OG000|Outcome|Brief Intervention|"3-part Brief Intervention~Brief Alcohol Intervention: 3 part intervention: Part I is 15-minute multi-component motivational discussion in hospital which includes personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II is 15-minute follow-up in hospital to reinforce Part I. Part III is 15-minute follow-up telephone call at 2 weeks to reinforce Part I."
11103178|NCT01602172|OG001|Outcome|Attention Control|"Traditional Attention Control Condition~Lifestyle brochures: Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have."
11103179|NCT01602172|OG002|Outcome|Control|"Control, Limited Assessment~Lifestyle brochures: Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have."
11103180|NCT01602172|OG001|Outcome|Attention Control|"Attention Control Condition~Lifestyle brochures: Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have."
11103181|NCT01602172|OG000|Outcome|Brief Alcohol Intervention (BI)|"3-part Brief Intervention~Brief Alcohol Intervention: 3 part intervention: Part I is 15-minute multi-component motivational discussion in hospital which includes personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II is 15-minute follow-up in hospital to reinforce Part I. Part III is 15-minute follow-up telephone call at 2 weeks to reinforce Part I."
11103182|NCT01602172|OG002|Outcome|Control|"Attention Control, Limited Assessment~Lifestyle brochures: Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have."
11103183|NCT01602172|OG000|Outcome|Brief Intervention|"3-part Brief Intervention. Part I is 15-minute multi-component motivational discussion in hospital which includes personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II is 15-minute follow-up in hospital to reinforce Part I. Part III is 15-minute follow-up telephone call at 2 weeks to reinforce Part I.~Brief Alcohol Intervention: 3 part intervention: Part I is 15-minute multi-component motivational discussion in hospital which includes personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II is 15-minute follow-up in hospital to reinforce Part I. Part III is 15-minute follow-up telephone call at 2 weeks to reinforce Part I."
11126478|NCT01733628|BG000|Baseline|Bevacizumab + Chemotherapy|Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
10846741|NCT00279591|OG000|Outcome|Intervention Group|
10846742|NCT00279591|OG001|Outcome|Control Group|
10846743|NCT00279591|EG000|Reported Event|Control Group|Oscillometric Blood Pressure Monitoring
10846744|NCT00279591|EG001|Reported Event|Intervention Group|Near Continuous Blood Pressure Monitoring
11103184|NCT01602172|OG001|Outcome|Attention Control|"Participants in this arm will complete all the screening and outcome measures that the Brief Intervention participants complete but will not receive any of the Brief Intervention treatments. They will receive a set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have.~Lifestyle brochures: Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant."
11103185|NCT01602172|OG002|Outcome|Control|"Participants in this arm will complete only drinking quantity measures at baseline and 6 months post baseline. They will receive a set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have.~Lifestyle brochures: Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have."
11103186|NCT01602172|EG000|Reported Event|Brief Alcohol Intervention (BI)|"Brief Intervention Condition--3 part motivational discussion in and out of hospital~Brief Alcohol Intervention: 3 part intervention: Part I was a 15-minute multi-component motivational discussion in hospital which included personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II was a 15-minute follow-up in hospital to reinforce Part I. Part III was 15-minute follow-up telephone call at 2 weeks to reinforce Part I."
11103187|NCT01602172|EG001|Reported Event|Attention Control|"Traditional Attention Control Condition~Lifestyle brochures: Set of educational brochures/brochures which contained information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant called patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) had."
11103188|NCT01602172|EG002|Reported Event|Control|"Attention Control, Limited Assessment~Lifestyle brochures: Set of educational brochures/brochures which contained information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant called patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) had."
11103189|NCT01602224|BG000|Baseline|100 mg Tabalumab+Dexamethasone+Bortezomib|"Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 milligram per square meter (mg/m^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103190|NCT01602224|BG001|Baseline|300 mg Tabalumab+Dexamethasone+Bortezomib|"Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103191|NCT01602224|BG002|Baseline|Placebo Comparator: Placebo + Dexamethasone + Bortezomib|"Placebo administered once IV on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103192|NCT01602224|BG003|Baseline|Total|Total of all reporting groups
11103193|NCT01602224|FG000|Participant Flow|100 mg Tabalumab+Dexamethasone+Bortezomib|"Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib (BTZ) 1.3 milligram per square meter (mg/m^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103194|NCT01602224|FG001|Participant Flow|300 mg Tabalumab+Dexamethasone+Bortezomib|"Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103195|NCT01602224|FG002|Participant Flow|Placebo Comparator: Placebo + Dexamethasone + Bortezomib|"Placebo administered once IV on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103196|NCT01602224|OG000|Outcome|100 mg Tabalumab+Dexamethasone+Bortezomib|"Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 milligram per square meter (mg/m^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103197|NCT01602224|OG001|Outcome|300 mg Tabalumab+Dexamethasone+Bortezomib|"Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103198|NCT01602224|OG002|Outcome|Placebo Comparator: Placebo + Dexamethasone + Bortezomib|"Placebo administered once IV on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103199|NCT01602224|OG002|Outcome|Placebo Comparator: Placebo + Dexamethasone + Bortezomib|"Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103200|NCT01602224|OG002|Outcome|Placebo Comparator: Placebo + Dexamethasone + Bortezombib|"Placebo administered once IV on Day 1 every 21 days for 8 cycles.Placebo administered once IV on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103201|NCT01602224|EG000|Reported Event|100 mg Tabalumab+Dexamethasone+Bortezomib|"Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 milligram per square meter (mg/m^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103202|NCT01602224|EG001|Reported Event|300 mg Tabalumab+Dexamethasone+Bortezomib|"Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles.~Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103203|NCT01602224|EG002|Reported Event|Placebo Comparator: Placebo + Dexamethasone + Bortezomib|"Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles.~Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles."
11103204|NCT01602315|BG000|Baseline|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
11103205|NCT01602315|BG001|Baseline|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
11103206|NCT01602315|BG002|Baseline|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
11103207|NCT01602315|BG003|Baseline|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
11103208|NCT01602315|BG004|Baseline|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103209|NCT01602315|BG005|Baseline|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103210|NCT01602315|BG006|Baseline|Arm 3 - BYL719+Cetuximab (Non-randomized)|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
11103211|NCT01602315|BG007|Baseline|Total|Total of all reporting groups
11103212|NCT01602315|FG000|Participant Flow|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
11103213|NCT01602315|FG001|Participant Flow|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
11103214|NCT01602315|FG002|Participant Flow|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
11103215|NCT01602315|FG003|Participant Flow|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
11103216|NCT01602315|FG004|Participant Flow|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103217|NCT01602315|FG005|Participant Flow|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103218|NCT01602315|FG006|Participant Flow|Arm 3 - BYL719+Cetuximab (Non-randomized)|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
11103219|NCT01602315|OG000|Outcome|Arm A - 300mg BYL719+Cetuximab|
11103220|NCT01602315|OG001|Outcome|Arm A - 400mg BYL719+Cetuximab|
11103221|NCT01602315|OG000|Outcome|Arm B- 300mg BYL719+Cetuximab|
11103222|NCT01602315|OG000|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
11103223|NCT01602315|OG001|Outcome|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
11103224|NCT01602315|OG002|Outcome|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
11103225|NCT01602315|OG003|Outcome|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
11103226|NCT01602315|OG004|Outcome|All Patients|All patients in Phase Ib
11103227|NCT01602315|OG000|Outcome|BYL719+ Cetuximab (Randomized)|300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103228|NCT01602315|OG001|Outcome|Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103229|NCT01602315|OG000|Outcome|BYL719+ Cetuximab (Non-randomized)|300mg BYL719 with cetuximab in patients resistant to platinum-based therapy and cetuximab in Phase II
11103230|NCT01602315|OG001|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
11103231|NCT01602315|OG002|Outcome|Arm A: 400mg BYL719 + Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
11103232|NCT01602315|OG003|Outcome|Arm B: 300mg BYL719 + Cetuximab|300mg BYL719 in oral suspension with cetuximab
11103233|NCT01602315|OG000|Outcome|Arm 2B - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
11103234|NCT01602315|OG000|Outcome|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103235|NCT01602315|OG001|Outcome|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103236|NCT01602315|OG002|Outcome|All Patients|
11103237|NCT01602315|OG000|Outcome|Arm 3 - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
11103238|NCT01602315|OG002|Outcome|All Patients (Phase II)|
11103239|NCT01602315|OG004|Outcome|All Patients|BYL719 + Cetuximab in Phase II (non-randomized) in patients resistant to or intolerant/ineligible for platinum-based
11103240|NCT01602315|OG001|Outcome|Arm B: BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
11103241|NCT01602315|OG002|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
11103242|NCT01602315|OG003|Outcome|Arm A: 400mg BYL719 + Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
11103243|NCT01602315|OG002|Outcome|Arm 2B - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
11103244|NCT01602315|OG002|Outcome|BYL719=Cetuximab (Non-randomized)|300mg BYL719with cetuximab in patients resistant to platinum-based therapy and cetuximab in Phase II
11103245|NCT01602315|EG000|Reported Event|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab
11103246|NCT01602315|EG001|Reported Event|Arm A: 400 mg BYL719 + Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
11103247|NCT01602315|EG002|Reported Event|Arm B - BYL719 + Cetuximab Oral Suspension|300mg BYL719 as crushed FC tablets with cetuximab in patients with swallowing dysfunction
11103248|NCT01602315|EG003|Reported Event|Arm C - BYL719+Cetuximab Dispersible Tablets|300mg BYL719 dispersible tablets with cetuximab in patients with swallowing dysfunction administered via G-tube
11103249|NCT01602315|EG004|Reported Event|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
11103250|NCT01602315|EG005|Reported Event|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy
11103251|NCT01602315|EG006|Reported Event|Arm 3 - BYL719+Cetuximab (Non-randomized)|300mg BYL719 with cetuximab in Phase II in patients resistant to Platinum-based therapy and cetuximab.
11103252|NCT01602315|EG007|Reported Event|All Patients|All patients
11103253|NCT01602341|BG000|Baseline|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103254|NCT01602341|BG001|Baseline|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103255|NCT01602341|BG002|Baseline|Total|Total of all reporting groups
11103256|NCT01602341|FG000|Participant Flow|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate atopic dermatitis (AD), once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103257|NCT01602341|FG001|Participant Flow|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103258|NCT01602341|OG000|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103259|NCT01602341|OG001|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103260|NCT01602341|OG002|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103261|NCT01602341|OG003|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103262|NCT01602341|OG000|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103263|NCT01602341|OG001|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103264|NCT01602341|EG000|Reported Event|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103265|NCT01602341|EG001|Reported Event|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
11103266|NCT01602419|BG000|Baseline|SAF Population|Of the 120 patients enrolled in this study, 111 received at least one dose of Wilate and were included in the SAF population
11126479|NCT01733628|FG000|Participant Flow|Bevacizumab + Chemotherapy|Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
11004210|NCT01075984|OG000|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
11004211|NCT01075984|OG001|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
11004212|NCT01075984|OG002|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
11004213|NCT01075984|OG000|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
11004214|NCT01075984|OG001|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
11004215|NCT01075984|OG002|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
11004216|NCT01075984|EG000|Reported Event|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
11004217|NCT01075984|EG001|Reported Event|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
11004218|NCT01075984|EG002|Reported Event|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
11004219|NCT01075984|EG003|Reported Event|POS 300 mg IV BID (Cohort 2 and 3)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2); POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
11004220|NCT01076010|BG000|Baseline|Sorafenib Crossover to Tivozanib|The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors [RECIST] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
11004221|NCT01076010|BG001|Baseline|First Line Tivozanib|The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
11004222|NCT01076010|BG002|Baseline|First Line Sorafenib|The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
11004223|NCT01076010|BG003|Baseline|Total|Total of all reporting groups
11004224|NCT01076010|FG000|Participant Flow|Sorafenib Crossover to Tivozanib|The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors [RECIST] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
11004225|NCT01076010|FG001|Participant Flow|First Line Tivozanib.|The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
11004226|NCT01076010|FG002|Participant Flow|First Line Sorafenib.|The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
11004227|NCT01076010|OG000|Outcome|Sorafenib Crossover to Tivozanib|The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors [RECIST] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
11004228|NCT01076010|OG001|Outcome|First Line Tivozanib.|The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
11004229|NCT01076010|OG002|Outcome|First Line Sorafenib.|The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
11004230|NCT01076010|EG000|Reported Event|Sorafenib Crossover to Tivozanib|The subjects who failed sorafenib (had RECIST-defined progressive disease) on the parent protocol will be offered tivozanib hydrochloride.
11004231|NCT01076010|EG001|Reported Event|First Line Tivozanib|The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
11004232|NCT01076010|EG002|Reported Event|First Line Sorafenib|The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
11004233|NCT01076036|BG000|Baseline|Investigational|CorPath® 200 System
11004234|NCT01076036|FG000|Participant Flow|Group 1|Group 1 was treated using the CorPath device.
11004235|NCT01076036|OG000|Outcome|Investigational|CorPath® 200 System
11004236|NCT01076036|EG000|Reported Event|Investigational|CorPath® 200 System
11004237|NCT01076049|BG000|Baseline|Standard of Care (SoC)|"For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).~Standard of Care (SoC): The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits."
11103267|NCT01602419|FG000|Participant Flow|Wilate|"A total of 120 patients were enrolled in this study.~Of the 120 patients enrolled into the study, 9 were excluded because they had not received any treatment with Wilate, leaving 111 patients in the safety (SAF) population. Of these 111 patients, 7 did not have a confirmed diagnosis of von Willebrand Disease (VWD) and 2 had another bleeding disorder, leaving 102 patients in the intention-to-treat (ITT) population. Of these 102 patients, 11 were excluded from the efficacy (EFF) population for the reasons summarised below."
11103268|NCT01602419|OG000|Outcome|SAF Population|All patients treated with at least one dose of Wilate during the study.
11103269|NCT01602419|OG000|Outcome|Prophylaxis|Wilate administered to patients in the context of prophylactic treatment.
11103270|NCT01602419|OG001|Outcome|Bleeding|Wilate administered for the treatment of acute or breakthrough BEs (does not include menstrual BEs).
11103271|NCT01602419|OG002|Outcome|Surgery|Wilate administered in the context of surgery.
11103272|NCT01602419|OG003|Outcome|Menstruation|Wilate administered in the context of menstrual BEs.
11103273|NCT01602419|OG004|Outcome|Prevention|Wilate administered for the purpose of preventing recurrent BEs in patients undergoing on-demand treatment or short-term prophylaxis in surgery only.
11103274|NCT01602419|OG000|Outcome|Patient Assessment of Acute BEs|Patient assessment of the efficacy of Wilate in the treatment of acute BEs.
11103275|NCT01602419|OG001|Outcome|Investigator Assessment of Acute BEs|Investigator assessment of the efficacy of Wilate in the treatment of acute BEs.
11103276|NCT01602419|OG002|Outcome|Patient Assessment of Breakthrough BEs|Patient assessment of the efficacy of Wilate in the treatment of breakthrough BEs.
11103277|NCT01602419|OG003|Outcome|Investigator Assessment of Breakthrough BEs|Investigator assessment on the efficacy of Wilate in the treatment of breakthrough BEs.
11103278|NCT01602419|OG004|Outcome|Patient Assessment of Menstrual BEs|Patient assessment on the efficacy of Wilate in the treatment of menstrual BEs.
11103279|NCT01602419|OG005|Outcome|Investigator Assessment of Menstrual BEs|Investigator assessment on the efficacy of Wilate in the treatment of menstrual BEs.
11103280|NCT01602419|OG000|Outcome|Spontaneous|Spontaneous bleeding causes
11103281|NCT01602419|OG001|Outcome|All Causes|All causes of bleeding episodes
11103282|NCT01602419|OG000|Outcome|Minor Surgeries|Efficacy analysis for minor surgeries including treatment with Wilate.
11103283|NCT01602419|OG001|Outcome|Major Surgeries|Efficacy analysis for major surgeries including treatment with Wilate.
11103284|NCT01602419|OG000|Outcome|Patients|Patient assessment of Wilate efficacy
11103285|NCT01602419|OG001|Outcome|Investigator|Investigator assessment of Wilate efficacy
11103286|NCT01602419|OG000|Outcome|Number of EDs|Number of exposure days
11103287|NCT01602419|OG000|Outcome|Baseline|Inhibitor results from patients at baseline
11103288|NCT01602419|OG001|Outcome|Follow-up|Inhibitor results from patients at follow-up
11103289|NCT01602419|OG000|Outcome|Prothrombin (Pre-infusion)|Pre-infusion assessment of prothrombin F1 + 2 (>2-fold ULN)
11103290|NCT01602419|OG001|Outcome|Prothrombin (Post-infusion)|Post-infusion assessment of prothrombin F1 + 2 (>2-fold ULN)
11103291|NCT01602419|OG002|Outcome|D-Dimer (Pre-infusion)|Pre-infusion assessment of D-dimer (>2-fold ULN)
11103292|NCT01602419|OG003|Outcome|D-Dimer (Post-infusion)|Post-infusion assessment of D-dimer (>2-fold ULN)
11103293|NCT01602419|OG000|Outcome|Dose of Wilate Per Infusion, IU/kg Per Infusion|Dose of Wilate given on-demand per infusion, units per kg per infusion
11103294|NCT01602419|OG000|Outcome|Dose of Wilate Per BE, IU/kg Per BE|Dose of Wilate given on-demand per BE
11103295|NCT01602419|OG000|Outcome|Dose of Wilate Per Menstrual BE, IU/kg Per Menstrual BE|Dose of Wilate given to participants per menstrual BE, units per kg per menstrual BE
11103296|NCT01602419|OG000|Outcome|Number of Exposure Days|Number of prophylactic exposure days.
11103297|NCT01602419|OG000|Outcome|Number of Wilate Infusions Per Week|The number of prophylactic Wilate infusions given to participants per week.
11103298|NCT01602419|OG000|Outcome|Dose of Wilate Per Week, IU/kg Per Week|The prophylactic dose of Wilate given to participants per week
11103299|NCT01602419|OG000|Outcome|Dose of Wilate Per Infusion, IU/kg Per Infusion|Dose of prophylactic Wilate administered per infusion
11103300|NCT01602419|OG000|Outcome|Number of Exposure Days (EDs)|Number of prophylactic exposure days
11103301|NCT01602419|OG000|Outcome|Number of Wilate Infusions Per Week|The prophylactic dose of Wilate given to participants per week
11103302|NCT01602419|OG000|Outcome|Dose of Wilate Per Week, IU/kg Per Week|The prophylactic dose of Wilate given to participants per week, per kg
11103303|NCT01602419|OG000|Outcome|Dose of Wilate Per Infusion, IU/kg Per Infusion|The prophylactic dose of Wilate given to participants per infusion, per kg per infusion
11103304|NCT01602419|OG000|Outcome|Dose of Wilate Per Infusion, IU/kg Per Infusion|The dose of Wilate given to participants per infusions, per kg to treat breakthrough bleeds
11103305|NCT01602419|OG000|Outcome|Dose of Wilate Per Breakthrough Bleed|The dose of Wilate given to participants per breakthrough bleed, units per kg per breakthrough bleed
11103306|NCT01602419|OG000|Outcome|Dose of Wilate Per Infusion, IU/kg Per Infusion|Dose of Wilate per infusion, units per kg in patients following surgery.
11103307|NCT01602419|OG000|Outcome|Dose of Wilate Per Procedure, IU/kg Per Procedure|Dose of Wilate per procedure, units per kg in patients following surgery
11103308|NCT01602419|OG000|Outcome|EFF-PC|Efficacy population undergoing continuous prophylaxis.
11103309|NCT01602419|OG001|Outcome|EFF-PI|Efficacy population undergoing intermittent prophylaxis.
11103310|NCT01602419|EG000|Reported Event|SAF Population|All patients who received at least one dose of Wilate during the study.
11103311|NCT01602484|BG000|Baseline|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
11103312|NCT01602484|BG001|Baseline|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
11103313|NCT01602484|BG002|Baseline|Total|Total of all reporting groups
11103314|NCT01602484|FG000|Participant Flow|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
11103315|NCT01602484|FG001|Participant Flow|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
11103316|NCT01602484|OG000|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
11103317|NCT01602484|OG001|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
11103318|NCT01602484|EG000|Reported Event|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
11103319|NCT01602484|EG001|Reported Event|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
11103320|NCT01602510|BG000|Baseline|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200 mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
11103321|NCT01602510|FG000|Participant Flow|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
11103322|NCT01602510|FG001|Participant Flow|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
11103323|NCT01602510|FG002|Participant Flow|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
11103324|NCT01602510|OG000|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
11103325|NCT01602510|OG001|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
11103326|NCT01602510|EG000|Reported Event|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
11103327|NCT01602510|EG001|Reported Event|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
11103328|NCT01602549|BG000|Baseline|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
11103329|NCT01602549|BG001|Baseline|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
11103330|NCT01602549|BG002|Baseline|Total|Total of all reporting groups
11103331|NCT01602549|FG000|Participant Flow|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
11103332|NCT01602549|FG001|Participant Flow|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
11103333|NCT01602549|OG000|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
11103334|NCT01602549|OG001|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
11103335|NCT01602549|OG002|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
11103336|NCT01602549|EG000|Reported Event|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
11103337|NCT01602549|EG001|Reported Event|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
11103338|NCT01602549|EG002|Reported Event|GSK962040 125 mg|Participants received GSK962040 125 milligrams (mg) administered orally once daily for 7 to 9 days.
11126480|NCT01733628|OG000|Outcome|Bevacizumab + Chemotherapy|Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
11126481|NCT01733628|EG000|Reported Event|Bevacizumab + Chemotherapy|"The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab.~The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent.~Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143)."
11126482|NCT01733680|BG000|Baseline|Arm 1-Amiloride|Subjects received amiloride hydrochloride (5 mg for 2 weeks, 10 mg for 3 week, and 15 mg for 3 weeks.
11126483|NCT01733680|BG001|Baseline|Arm 2-Placebo|Subjects received placebo for 8 weeks.
11126484|NCT01733680|BG002|Baseline|Total|Total of all reporting groups
11126485|NCT01733680|FG000|Participant Flow|Amiloride|"Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.~Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.~amiloride: Subjects will take either amiloride hydrochloride or placebo for 8 weeks.~Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement"
11103339|NCT01602562|BG000|Baseline|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103340|NCT01602562|BG001|Baseline|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103341|NCT01602562|BG002|Baseline|Total|Total of all reporting groups
11103342|NCT01602562|FG000|Participant Flow|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103343|NCT01602562|FG001|Participant Flow|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103344|NCT01602562|OG000|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103345|NCT01602562|OG001|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103346|NCT01602562|OG001|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and & <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103347|NCT01602562|EG000|Reported Event|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103348|NCT01602562|EG001|Reported Event|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
11103349|NCT01602614|BG000|Baseline|Group 1|≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
11103350|NCT01602614|BG001|Baseline|Group 2|≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment
11103351|NCT01602614|BG002|Baseline|Group 3|≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
11103352|NCT01602614|BG003|Baseline|Group 4|≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment
11103353|NCT01602614|BG004|Baseline|Total|Total of all reporting groups
11103354|NCT01602614|FG000|Participant Flow|Group 1|≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
11103355|NCT01602614|FG001|Participant Flow|Group 2|≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
11103356|NCT01602614|FG002|Participant Flow|Group 3|≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
11103357|NCT01602614|FG003|Participant Flow|Group 4|≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
11103358|NCT01602614|OG000|Outcome|Group 1|≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
11103359|NCT01602614|OG001|Outcome|Group 2|≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment
11103360|NCT01602614|OG002|Outcome|Group 3|≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
11103361|NCT01602614|OG003|Outcome|Group 4|≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment
11103362|NCT01602614|OG000|Outcome|Group 1|≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
11103363|NCT01602614|OG001|Outcome|Group 2|≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
11103364|NCT01602614|OG002|Outcome|Group 3|≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
11103365|NCT01602614|OG003|Outcome|Group 4|≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
11103366|NCT01602614|EG000|Reported Event|Group 1|≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
11103367|NCT01602614|EG001|Reported Event|Group 2|≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment
11103368|NCT01602614|EG002|Reported Event|Group 3|≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
11103369|NCT01602614|EG003|Reported Event|Group 4|≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment
11103370|NCT01602679|BG000|Baseline|Oral Micronized Progesterone Suspension, Then Placebo|"Participants first received oral micronized progesterone (100 mg p.o.) suspension. After a washout period of approximately 20 days, they then received Placebo.~oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects"
11103371|NCT01602679|BG001|Baseline|Placebo, Then Oral Micronized Progesterone Suspension|"Participants first received Placebo. After a washout period of approximately 20 days, they then received oral micronized progesterone suspension. Placebo contains only inert ingredients and is not expected to exert any direct physiological effects~Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension"
11103372|NCT01602679|BG002|Baseline|Total|Total of all reporting groups
11103373|NCT01602679|FG000|Participant Flow|Oral Micronized Progesterone Suspension, Then Placebo|"Participants first received oral micronized progesterone (100 mg p.o.) suspension. After a washout period of approximately 20 days, they then received placebo.~oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension"
11103374|NCT01602679|FG001|Participant Flow|Placebo, Then Oral Micronized Progesterone Suspension|"Participants first received Placebo. After a washout period of approximately 20 days, they then received oral micronized progesterone suspension. Placebo contains only inert ingredients and is not expected to exert any direct physiological effects~Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects"
11103375|NCT01602679|OG000|Outcome|Oral Micronized Progesterone Suspension|"oral micronized progesterone (100 mg p.o.) suspension~oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension"
11103376|NCT01602679|OG001|Outcome|Placebo|"Placebo contains only inert ingredients and is not expected to exert any direct physiological effects~Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects"
11103377|NCT01602679|EG000|Reported Event|Oral Micronized Progesterone Suspension|Oral micronized progesterone (100 mg) suspension
11103378|NCT01602679|EG001|Reported Event|Placebo|Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
11103379|NCT01602692|BG000|Baseline|Tumescent Solution With Dilute Epinephrine|"Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.~Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only"
11103380|NCT01602692|BG001|Baseline|Tumescent Solution With Dilute Lidocaine and Epinephrine|"Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).~Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)"
11103381|NCT01602692|BG002|Baseline|Total|Total of all reporting groups
11103382|NCT01602692|FG000|Participant Flow|Tumescent Solution With Dilute Epinephrine|"Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.~Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only"
11103383|NCT01602692|FG001|Participant Flow|Tumescent Solution With Dilute Lidocaine and Epinephrine|"Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).~Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)"
11103384|NCT01602692|OG000|Outcome|Tumescent Solution With Dilute Epinephrine|"Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.~Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only"
11103385|NCT01602692|OG001|Outcome|Tumescent Solution With Dilute Lidocaine and Epinephrine|"Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).~Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)"
11103386|NCT01602692|OG000|Outcome|Tumescent Solution With Dilute Epinephrine|Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction. Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
11103387|NCT01602692|OG001|Outcome|Tumescent Solution With Dilute Lidocaine and Epinephrine|Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000). Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
11103388|NCT01602692|OG000|Outcome|Tumescent Solution With Dilute Epinephrine|"Subjects in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.~Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only"
11103389|NCT01602692|OG001|Outcome|Tumescent Solution With Dilute Lidocaine and Epinephrine|"Subjects in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).~Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)"
11103390|NCT01602692|EG000|Reported Event|Tumescent Solution With Dilute Epinephrine|"Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.~Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only"
11103391|NCT01602692|EG001|Reported Event|Tumescent Solution With Dilute Lidocaine and Epinephrine|"Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).~Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)"
11103392|NCT01602731|BG000|Baseline|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
11103393|NCT01602731|FG000|Participant Flow|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
11103394|NCT01602731|OG000|Outcome|Before AMDD|Adherence was measured by 30-day pill count before the use of AMDD
11103395|NCT01602731|OG001|Outcome|After AMDD|Adherence was measured with the use of the AMDD as a 30-day pill count
11103396|NCT01602731|OG000|Outcome|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
11103397|NCT01602731|EG000|Reported Event|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
11103398|NCT01602744|BG000|Baseline|Controll|The medications in this arm will not be screened.
11103399|NCT01602744|BG001|Baseline|Intervention STOPP/START|Screening medications with STOPP/START critera
11103400|NCT01602744|BG002|Baseline|Total|Total of all reporting groups
11103401|NCT01602744|FG000|Participant Flow|Controll|The medications in this arm will not be screened.
11103402|NCT01602744|FG001|Participant Flow|Intervention STOPP/START|Screening medications with STOPP/START critera
11103403|NCT01602744|OG000|Outcome|Controll|The medications in this arm will not be screened.
11103404|NCT01602744|OG001|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
11103405|NCT01602744|EG000|Reported Event|Controll|The medications in this arm will not be screened.
11103406|NCT01602744|EG001|Reported Event|Intervention STOPP/START|Screening medications with STOPP/START critera
11103407|NCT01602965|BG000|Baseline|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.~Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
11103408|NCT01602965|BG001|Baseline|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.~Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
11103409|NCT01602965|BG002|Baseline|Total|Total of all reporting groups
11103410|NCT01602965|FG000|Participant Flow|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.~Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
11103411|NCT01602965|FG001|Participant Flow|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.~Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
11103412|NCT01602965|OG000|Outcome|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.~Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
11103413|NCT01602965|OG001|Outcome|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.~Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
11103414|NCT01602965|EG000|Reported Event|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.~Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
11103415|NCT01602965|EG001|Reported Event|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.~Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
11103416|NCT01603056|BG000|Baseline|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
11103417|NCT01603056|BG001|Baseline|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
11103418|NCT01603056|BG002|Baseline|Total|Total of all reporting groups
11103419|NCT01603056|FG000|Participant Flow|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
11103420|NCT01603056|FG001|Participant Flow|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
11103421|NCT01603056|OG000|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
11103422|NCT01603056|OG001|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
11103423|NCT01603056|EG000|Reported Event|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
11103424|NCT01603056|EG001|Reported Event|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
11103425|NCT01603082|BG000|Baseline|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
11103426|NCT01603082|BG001|Baseline|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
11103427|NCT01603082|BG002|Baseline|Total|Total of all reporting groups
11103428|NCT01603082|FG000|Participant Flow|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
11103429|NCT01603082|FG001|Participant Flow|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
11103430|NCT01603082|OG000|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
11103431|NCT01603082|OG001|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
11103432|NCT01603082|EG000|Reported Event|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
11103433|NCT01603082|EG001|Reported Event|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
11103434|NCT01603277|BG000|Baseline|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
11103435|NCT01603277|BG001|Baseline|Normal Saline|Placebo: Normal Saline
11103436|NCT01603277|BG002|Baseline|Total|Total of all reporting groups
11103437|NCT01603277|FG000|Participant Flow|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
11103438|NCT01603277|FG001|Participant Flow|Normal Saline|Placebo: Normal Saline
11103439|NCT01603277|OG000|Outcome|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
11103440|NCT01603277|OG001|Outcome|Normal Saline|Placebo: Normal Saline
11103441|NCT01603277|EG000|Reported Event|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
11103442|NCT01603277|EG001|Reported Event|Normal Saline|Placebo: Normal Saline
11103443|NCT01603355|BG000|Baseline|Tocilizumab|"Tocilizumab: Intravenous tocilizumab:~Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks"
11103444|NCT01603355|FG000|Participant Flow|Tocilizumab|"Tocilizumab: Intravenous tocilizumab:~Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks"
11103445|NCT01603355|OG000|Outcome|Tocilizumab|"Tocilizumab: Intravenous tocilizumab:~Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks"
11103446|NCT01603355|EG000|Reported Event|Tocilizumab|"Tocilizumab: Intravenous tocilizumab:~Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks"
11103447|NCT01603368|BG000|Baseline|Probiotic|Lactobacillus reuteri
11103448|NCT01603368|BG001|Baseline|Placebo|
11103449|NCT01603368|BG002|Baseline|Total|Total of all reporting groups
11103450|NCT01603368|FG000|Participant Flow|Lactobacillus Reuteri|"Lactobacillus reuteri DSM 17938, 125 million bacteria/day~Lactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day"
11103451|NCT01603368|FG001|Participant Flow|Placebo|"The same oil drops as the active study product but without Lactobacillus reuteri~Placebo: Oil drops without Lactobacillus reuteri"
11103452|NCT01603368|OG000|Outcome|Lactobacillus Reuteri|"Lactobacillus reuteri DSM 17938, 125 million bacteria/day~Lactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day"
11103453|NCT01603368|OG001|Outcome|Placebo|"The same oil drops as the active study product but without Lactobacillus reuteri~Placebo: Oil drops without Lactobacillus reuteri"
11103454|NCT01603368|EG000|Reported Event|Lactobacillus Reuteri|"Lactobacillus reuteri DSM 17938, 125 million bacteria/day~Lactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day"
11103455|NCT01603368|EG001|Reported Event|Placebo|"The same oil drops as the active study product but without Lactobacillus reuteri~Placebo: Oil drops without Lactobacillus reuteri"
11103456|NCT01603420|BG000|Baseline|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103457|NCT01603420|BG001|Baseline|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103458|NCT01603420|BG002|Baseline|Total|Total of all reporting groups
11103459|NCT01603420|FG000|Participant Flow|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103460|NCT01603420|FG001|Participant Flow|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103461|NCT01603420|OG000|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103462|NCT01603420|OG001|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103463|NCT01603420|OG000|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103464|NCT01603420|OG001|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103465|NCT01603420|OG001|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103466|NCT01603420|EG000|Reported Event|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103467|NCT01603420|EG001|Reported Event|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
11103468|NCT01603459|BG000|Baseline|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
11103469|NCT01603459|FG000|Participant Flow|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
11103470|NCT01603459|OG000|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
11103471|NCT01603459|OG001|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
11103472|NCT01603459|OG002|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
11103473|NCT01603459|OG003|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
11103474|NCT01603459|OG004|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
11103475|NCT01603459|OG005|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
11103476|NCT01603459|OG000|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
11103477|NCT01603459|OG001|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
11103478|NCT01603459|OG002|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
11103479|NCT01603459|OG000|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
11103480|NCT01603459|OG001|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
11103481|NCT01603459|OG002|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
11103482|NCT01603459|OG000|Outcome|IncobotulinumtoxinA (Xeomin): Timeframe 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
11103483|NCT01603459|OG001|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
11103484|NCT01603459|OG002|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
11103485|NCT01603459|OG000|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
11103486|NCT01603459|OG000|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
11103487|NCT01603459|OG002|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
11103488|NCT01603459|OG000|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
11103489|NCT01603459|EG000|Reported Event|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
11103490|NCT01603602|BG000|Baseline|BOTOX® 6 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
11103491|NCT01603602|BG001|Baseline|BOTOX® 3 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
11103492|NCT01603602|BG002|Baseline|Placebo|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
11103493|NCT01603602|BG003|Baseline|Total|Total of all reporting groups
11103494|NCT01603602|FG000|Participant Flow|BOTOX® 6 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
11103495|NCT01603602|FG001|Participant Flow|BOTOX® 3 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
11103496|NCT01603602|FG002|Participant Flow|Placebo|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
11103497|NCT01603602|OG000|Outcome|BOTOX® 6 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
11103498|NCT01603602|OG001|Outcome|BOTOX® 3 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
11103499|NCT01603602|OG002|Outcome|Placebo|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
11103500|NCT01603602|EG000|Reported Event|BOTOX® 6 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
11103501|NCT01603602|EG001|Reported Event|BOTOX® 3 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
11103502|NCT01603602|EG002|Reported Event|Placebo|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
11103503|NCT01603615|BG000|Baseline|BOTOX®|Participants received a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in previous study.
11103504|NCT01603615|FG000|Participant Flow|BOTOX®|Participants received a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in previous study.
11103505|NCT01603615|OG000|Outcome|BOTOX®|Participants received a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in previous study.
11103506|NCT01603615|EG000|Reported Event|BOTOX®|Participants received a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in previous study.
11103507|NCT01603628|BG000|Baseline|BOTOX® 8 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).
11103508|NCT01603628|BG001|Baseline|BOTOX® 4 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.
11103509|NCT01603628|BG002|Baseline|Placebo|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.
11103510|NCT01603628|BG003|Baseline|Total|Total of all reporting groups
11103511|NCT01603628|FG000|Participant Flow|BOTOX® 8 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 units (U) per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).
11103512|NCT01603628|FG001|Participant Flow|BOTOX® 4 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.
11103513|NCT01603628|FG002|Participant Flow|Placebo|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.
11103514|NCT01603628|OG000|Outcome|BOTOX® 8 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).
11103515|NCT01603628|OG001|Outcome|BOTOX® 4 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.
11103516|NCT01603628|OG002|Outcome|Placebo|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.
11103517|NCT01603628|EG000|Reported Event|BOTOX® 8 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).
11103518|NCT01603628|EG001|Reported Event|BOTOX® 4 U/kg|Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.
11103519|NCT01603628|EG002|Reported Event|Placebo|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.
11126486|NCT01733680|FG001|Participant Flow|Placebo|"Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI~Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement"
11224508|NCT02360475|FG000|Participant Flow|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11103520|NCT01603641|BG000|Baseline|BOTOX®|Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study.
11103521|NCT01603641|FG000|Participant Flow|BOTOX®|Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study.
11103522|NCT01603641|OG000|Outcome|BOTOX®|Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study.
11103523|NCT01603641|EG000|Reported Event|BOTOX®|Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study.
11103524|NCT01603875|BG000|Baseline|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103525|NCT01603875|BG001|Baseline|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103526|NCT01603875|BG002|Baseline|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103527|NCT01603875|BG003|Baseline|Total|Total of all reporting groups
11103528|NCT01603875|FG000|Participant Flow|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103529|NCT01603875|FG001|Participant Flow|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103530|NCT01603875|FG002|Participant Flow|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103531|NCT01603875|OG000|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103532|NCT01603875|OG001|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103533|NCT01603875|OG002|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103534|NCT01603875|EG000|Reported Event|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103535|NCT01603875|EG001|Reported Event|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103536|NCT01603875|EG002|Reported Event|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
11103537|NCT01603940|BG000|Baseline|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
11103538|NCT01603940|BG001|Baseline|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
11103539|NCT01603940|BG002|Baseline|Total|Total of all reporting groups
11103540|NCT01603940|FG000|Participant Flow|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
11103541|NCT01603940|FG001|Participant Flow|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
11103542|NCT01603940|OG000|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
11103543|NCT01603940|OG001|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
11103544|NCT01603940|EG000|Reported Event|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
11103545|NCT01603940|EG001|Reported Event|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
11103546|NCT01604109|BG000|Baseline|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
11103547|NCT01604109|BG001|Baseline|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
11103548|NCT01604109|BG002|Baseline|Total|Total of all reporting groups
11103549|NCT01604109|FG000|Participant Flow|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
11103550|NCT01604109|FG001|Participant Flow|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
11103551|NCT01604109|OG000|Outcome|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
11103552|NCT01604109|OG001|Outcome|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
11103553|NCT01604109|EG000|Reported Event|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
11103554|NCT01604109|EG001|Reported Event|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
11103555|NCT01604122|BG000|Baseline|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
11103556|NCT01604122|BG001|Baseline|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
11103557|NCT01604122|BG002|Baseline|Total|Total of all reporting groups
11103558|NCT01604122|FG000|Participant Flow|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
11103559|NCT01604122|FG001|Participant Flow|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
11103560|NCT01604122|OG000|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
11103561|NCT01604122|OG001|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
11103562|NCT01604122|OG000|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
11103563|NCT01604122|EG000|Reported Event|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
11103564|NCT01604122|EG001|Reported Event|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
11103565|NCT01604265|BG000|Baseline|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
11103566|NCT01604265|BG001|Baseline|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
11103567|NCT01604265|BG002|Baseline|Total|Total of all reporting groups
11103568|NCT01604265|FG000|Participant Flow|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
11103569|NCT01604265|FG001|Participant Flow|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
11103570|NCT01604265|OG000|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
11103571|NCT01604265|OG001|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
11103572|NCT01604265|EG000|Reported Event|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
11103573|NCT01604265|EG001|Reported Event|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
11103574|NCT01604278|BG000|Baseline|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
11103575|NCT01604278|BG001|Baseline|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
11103576|NCT01604278|BG002|Baseline|Total|Total of all reporting groups
11103577|NCT01604278|FG000|Participant Flow|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
11103578|NCT01604278|FG001|Participant Flow|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
11103579|NCT01604278|OG000|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
11103580|NCT01604278|OG001|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
11103581|NCT01604278|EG000|Reported Event|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
11103582|NCT01604278|EG001|Reported Event|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
11103583|NCT01604291|BG000|Baseline|Peginterferon Alfa-2a + Ribavirin|Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103584|NCT01604291|BG001|Baseline|Peginterferon Alfa-2a + Ribavirin + Telaprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Teleprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103585|NCT01604291|BG002|Baseline|Peginterferon Alfa-2a + Ribavirin + Boceprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103586|NCT01604291|BG003|Baseline|No Information on Treatment Allocation|Participants for which Treatment Allocation Data is Unavailable
11103587|NCT01604291|BG004|Baseline|Total|Total of all reporting groups
11103588|NCT01604291|FG000|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103589|NCT01604291|FG001|Participant Flow|Peginterferon Alfa-2a + Ribavirin + Telaprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Teleprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103590|NCT01604291|FG002|Participant Flow|Peginterferon Alfa-2a + Ribavirin + Boceprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103591|NCT01604291|FG003|Participant Flow|No Information on Treatment Allocation|Participants for which Treatment Allocation Data is Unavailable.
11103592|NCT01604291|OG000|Outcome|Peginterferon Alfa-2a + Ribavirin|Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103593|NCT01604291|OG001|Outcome|Peginterferon Alfa-2a + Ribavirin + Telaprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103594|NCT01604291|OG002|Outcome|Peginterferon Alfa-2a + Ribavirin + Boceprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103595|NCT01604291|OG000|Outcome|All Participants|Participants who had dual or triple therapy as part of their drug regimen at the discretion of the investigator in accordance with the local prescribing information at the time of the study.
11103596|NCT01604291|OG000|Outcome|Peginterferon Alfa-2a + Ribvavirin|Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103597|NCT01604291|OG001|Outcome|Peginterferon Alfa-2a + Ribavirin +Telaprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information
11103598|NCT01604291|OG002|Outcome|Peginterferon Alfa-2a + Ribavirin + Boceprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103599|NCT01604291|OG000|Outcome|Peginterferon Alfa-2a + Ribavirin +Telaprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103600|NCT01604291|OG001|Outcome|Peginterferon Alfa-2a + Ribavirin + Boceprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103601|NCT01604291|OG001|Outcome|Peginterferon Alfa-2a + Ribavirin +Telaprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103602|NCT01604291|OG001|Outcome|Peginterferon Alfa-2a + Ribavirin + Boceprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103603|NCT01604291|OG001|Outcome|Peginterferon Alfa-2a + Ribavirin + Telaprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103604|NCT01604291|OG002|Outcome|Peginterferon Alfa-2a +Ribavirin + Boceprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103605|NCT01604291|EG000|Reported Event|Peginterferon Alfa-2a + Ribavirin|Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103606|NCT01604291|EG001|Reported Event|Peginterferon Alfa-2a + Ribavirin +Telaprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Teleprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103607|NCT01604291|EG002|Reported Event|Peginterferon Alfa-2a + Ribavirin + Boceprevir|Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
11103608|NCT01604343|BG000|Baseline|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103609|NCT01604343|BG001|Baseline|Sirukumab 50 mg q4w|All participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103610|NCT01604343|BG002|Baseline|Sirukumab 100 mg q2w|All participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103611|NCT01604343|BG003|Baseline|Total|Total of all reporting groups
11103612|NCT01604343|FG000|Participant Flow|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week (W) 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103613|NCT01604343|FG001|Participant Flow|Placebo to 50 mg q4w Due to EE/LE/CO|Participants who were assigned to placebo group and who met EE at Week 18 or LE at Week 40 or CO at Week 52 were re-randomized to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103614|NCT01604343|FG002|Participant Flow|Sirukumab 50 mg q4w|All participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103615|NCT01604343|FG003|Participant Flow|Placebo to 100 mg q2w Due to EE/LE/CO|Participants who were assigned to placebo group and who met EE at Week 18 or LE at Week 40 or CO at Week 52 were re-randomized to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103616|NCT01604343|FG004|Participant Flow|Sirukumab 100 mg q2w|All participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103617|NCT01604343|OG000|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103618|NCT01604343|OG001|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
11103619|NCT01604343|OG002|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
11103620|NCT01604343|EG000|Reported Event|Week 0 to Week 120-Placebo|Participants received matching placebo from week 0 to week 50, every 2 weeks (q2w) until either early escape (EE) at Week 18 or late escape (LE) at Week 40 or crossover (CO) at Week 52 and were rerandomized to subcutaneous (SC) sirukumab 50 mg q4w or sirukumab 100 mg q2w dose regimens up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11224509|NCT02360475|FG001|Participant Flow|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11103621|NCT01604343|EG001|Reported Event|W0 to W120-Placebo to Sirukumab 50 mg q4w Due to EE/LE or CO|Participants who received placebo in the placebo controlled period were rerandomized (due to EE at Week 18 or LE at Week 40 or CO at Week 52) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103622|NCT01604343|EG002|Reported Event|W0 to W120- Sirukumab 50 mg q4w|Participants received 50 mg of sirukumab SC injections at Weeks 0, 4, and q4w through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103623|NCT01604343|EG003|Reported Event|W0 to W120- Placebo to Sirukumab 100 mg q2w Due to EE/LE or CO|Participants who received placebo in the placebo controlled period were rerandomized (due to EE at Week 18 or LE at Week 40 or CO at Week 52) to receive subcutaneous (SC) sirukumab 100 mg q2w dose up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103624|NCT01604343|EG004|Reported Event|W0 to W120-Sirukumab 100 mg q2w|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2 and q2w throught Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
11103625|NCT01604408|BG000|Baseline|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
11103626|NCT01604408|BG001|Baseline|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
11103627|NCT01604408|BG002|Baseline|Total|Total of all reporting groups
11103628|NCT01604408|FG000|Participant Flow|LY2495655|Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.
11103629|NCT01604408|FG001|Participant Flow|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
11103630|NCT01604408|OG000|Outcome|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
10846745|NCT00279708|BG000|Baseline|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
11103631|NCT01604408|OG001|Outcome|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
11103632|NCT01604408|EG000|Reported Event|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
11103633|NCT01604408|EG001|Reported Event|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
11103634|NCT01604772|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
11103635|NCT01604772|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
11103636|NCT01604772|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|
11103637|NCT01604772|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
11103638|NCT01604772|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
11103639|NCT01604785|BG000|Baseline|Experimental Treatment Group|"Propofol at subanesthetic dose via IV push~Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses"
11103640|NCT01604785|BG001|Baseline|Standard Treatment Group|"Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion~Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide"
11103641|NCT01604785|BG002|Baseline|Total|Total of all reporting groups
11103642|NCT01604785|FG000|Participant Flow|Experimental Treatment Group|"Propofol at subanesthetic dose via IV push~Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses~Total enrollment = 37 subjects"
11103643|NCT01604785|FG001|Participant Flow|Standard Treatment Group|"Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion~Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide~Total enrollment = 37 subjects"
11103644|NCT01604785|OG000|Outcome|Experimental Treatment Group|"Propofol at subanesthetic dose via IV push~Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses~Total enrollment = 30 subjects"
11103645|NCT01604785|OG001|Outcome|Standard Treatment Group|"Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion~Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide~Total enrollment = 36 subjects"
11103646|NCT01604785|EG000|Reported Event|Experimental Treatment Group|"Propofol at subanesthetic dose via IV push~Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses"
11103647|NCT01604785|EG001|Reported Event|Standard Treatment Group|"Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion~Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide"
11103648|NCT01604824|BG000|Baseline|PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)|Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103649|NCT01604824|BG001|Baseline|PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)|Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103650|NCT01604824|BG002|Baseline|PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)|Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103651|NCT01604824|BG003|Baseline|PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)|Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103652|NCT01604824|BG004|Baseline|Total|Total of all reporting groups
11103653|NCT01604824|FG000|Participant Flow|PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)|Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103654|NCT01604824|FG001|Participant Flow|PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)|Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103655|NCT01604824|FG002|Participant Flow|PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)|Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103656|NCT01604824|FG003|Participant Flow|PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)|Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103657|NCT01604824|FG004|Participant Flow|PCSK9 GOFm (Cohort 1: Group A and Group B)|Participants with a GOFm in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC, Q2W for an additional 3 years.
11103658|NCT01604824|FG005|Participant Flow|PCSK9 GOFm/ApoB LOFm (Cohort 2: Group C and Group D)|Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103659|NCT01604824|OG000|Outcome|PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)|Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103660|NCT01604824|OG001|Outcome|PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)|Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103661|NCT01604824|OG002|Outcome|PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)|Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103662|NCT01604824|OG003|Outcome|PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)|Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103663|NCT01604824|EG000|Reported Event|PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)|Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103664|NCT01604824|EG001|Reported Event|PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)|Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103665|NCT01604824|EG002|Reported Event|PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)|Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103666|NCT01604824|EG003|Reported Event|PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2:Group D)|Subjects with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Afterwards, subjects continued in an open-label extension period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103667|NCT01604824|EG004|Reported Event|OLE Period: PCSK9 GOFm (Cohort 1) Group A & Group B|Subjects with a GOFm in PCSK9 gene (Cohort 1): alirocumab 150 mg subcutaneous (SC) injection at Week 0 (Day 1), Week 2 (Day 15), Weeks 4, 6 and 10 (matching placebo at Week 8, 12 and 14) during the double-blind period (Group A) or at Week 2 (Day 15), Weeks 4, 6, 8 and 12 (matching placebo at Week 0 [Day 1], Weeks 10 and 14) during the double-blind period (Group B). Afterwards, subjects continued in an OLE period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103668|NCT01604824|EG005|Reported Event|OLE Period: PCSK9 GOFm/ ApoB LOFm (Cohort 2) Group C & Group D|Subjects with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2): alirocumab 150 mg SC injection at Week 0 (Day 1), Week 2 (Day 15), Weeks 4, 6 and 10 (matching placebo at Weeks 8, 12 and 14) during the double-blind period (Group C) or at Week 2 (Day 15), Weeks 4, 6, 8 and 12 (matching placebo at Week 0 [Day 1], 10 and 14) during the double-blind period (Group D). Afterwards, subjects continued in an OLE period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
11103669|NCT01604850|BG000|Baseline|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
11103670|NCT01604850|BG001|Baseline|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
11103671|NCT01604850|BG002|Baseline|Total|Total of all reporting groups
11103672|NCT01604850|FG000|Participant Flow|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
11103673|NCT01604850|FG001|Participant Flow|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
11103674|NCT01604850|OG000|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
11103675|NCT01604850|OG001|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
11103676|NCT01604850|EG000|Reported Event|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
11103677|NCT01604850|EG001|Reported Event|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
11103678|NCT01604941|BG000|Baseline|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
11103679|NCT01604941|BG001|Baseline|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
11103680|NCT01604941|BG002|Baseline|Total|Total of all reporting groups
11103681|NCT01604941|FG000|Participant Flow|SPD602 50mg/mg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
11103682|NCT01604941|FG001|Participant Flow|SPD602 75mg/kg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
11103683|NCT01604941|FG002|Participant Flow|SPD602 50mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
11103684|NCT01604941|FG003|Participant Flow|SPD602 75mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
11103685|NCT01604941|FG004|Participant Flow|SPD602 50mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 50 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
11103686|NCT01604941|FG005|Participant Flow|SPD602 75mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 75 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
11103687|NCT01604941|OG000|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
11103688|NCT01604941|OG001|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
11103689|NCT01604941|EG000|Reported Event|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
11103690|NCT01604941|EG001|Reported Event|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
11103691|NCT01605032|BG000|Baseline|Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)|"CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4.~TRANSPLANT: Patients undergo autologous PBSCT on day 0.~Busulfan: Given IV~Melphalan: Given IV~Bortezomib: Given IV~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT~Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT"
11103692|NCT01605032|FG000|Participant Flow|Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)|"CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4.~TRANSPLANT: Patients undergo autologous PBSCT on day 0.~Busulfan: Given IV~Melphalan: Given IV~Bortezomib: Given IV~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT~Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT"
11103693|NCT01605032|OG000|Outcome|Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)|"CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4.~TRANSPLANT: Patients undergo autologous PBSCT on day 0.~Busulfan: Given IV~Melphalan: Given IV~Bortezomib: Given IV~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT~Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT"
11103694|NCT01605032|EG000|Reported Event|Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)|"CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4.~TRANSPLANT: Patients undergo autologous PBSCT on day 0.~Busulfan: Given IV~Melphalan: Given IV~Bortezomib: Given IV~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT~Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT"
11103695|NCT01605071|BG000|Baseline|Early Postmenopausal|"Postmenopausal women within 6 years of last menses who never used estrogen-based hormone therapy~Estradiol: 1 week of transdermal estradiol (0.15mg)~1 week of transdermal placebo"
11103696|NCT01605071|BG001|Baseline|Late Postmenopausal|"Postmenopausal women more than 10 years since last menses who never used estrogen-based hormone therapy~Estradiol: 1 week of transdermal estradiol (0.15mg)~1 week of transdermal placebo"
11103697|NCT01605071|BG002|Baseline|Total|Total of all reporting groups
11103698|NCT01605071|FG000|Participant Flow|Early Postmenopausal|"Postmenopausal women within 6 years of last menses who never used estrogen-based hormone therapy~Estradiol: 1 week of transdermal estradiol (0.15mg)~1 week of transdermal placebo"
11103699|NCT01605071|FG001|Participant Flow|Late Postmenopausal|"Postmenopausal women more than 10 years since last menses who never used estrogen-based hormone therapy~Estradiol: 1 week of transdermal estradiol (0.15mg)~1 week of transdermal placebo"
11103700|NCT01605071|OG000|Outcome|Early Postmenopausal|"Postmenopausal women within 6 years of last menses who never used estrogen-based hormone therapy~Estradiol: 1 week of transdermal estradiol (0.15mg)~1 week of transdermal placebo"
11103701|NCT01605071|OG001|Outcome|Late Postmenopausal|"Postmenopausal women more than 10 years since last menses who never used estrogen-based hormone therapy~Estradiol: 1 week of transdermal estradiol (0.15mg)~1 week of transdermal placebo"
11103702|NCT01605071|OG000|Outcome|Early Postmenopausal|Postmenopausal women within 6 years of last menses who never used estrogen-based hormone therapy
11103703|NCT01605071|OG001|Outcome|Late Postmenopausal|Postmenopausal women more than 10 years since last menses who never used estrogen-based hormone therapy
11103704|NCT01605071|EG000|Reported Event|Placebo|1 week of transdermal placebo
11103705|NCT01605071|EG001|Reported Event|Estrogen|Estradiol: 1 week of transdermal estradiol (0.15mg)
11103706|NCT01605097|BG000|Baseline|HDR Interstitial Brachytherapy|"HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion~HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy"
11103707|NCT01605097|FG000|Participant Flow|High Dose Rate (HDR) Interstitial Brachytherapy|"HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion~HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy"
11103708|NCT01605097|OG000|Outcome|High Dose Rate (HDR) Interstitial Brachytherapy|"HDR prostate brachytherapy with dose escalation to 1250 centiGray (cGy) to the MRI-defined dominant intraprostatic lesion~HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy"
11103709|NCT01605097|OG000|Outcome|HDR Interstitial Brachytherapy|"HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion~HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy"
11103710|NCT01605097|EG000|Reported Event|HDR Interstitial Brachytherapy|"HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion~HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy"
11103711|NCT01605136|BG000|Baseline|Afamelanotide|"One 16mg subcutaneous implant every 2 months for 6 months.~Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months."
11103712|NCT01605136|BG001|Baseline|Placebo|"One placebo subcutaneous implant every 2 months for 6 months.~Placebo: One placebo subcutaneous implant every 2 months for 6 months"
11103713|NCT01605136|BG002|Baseline|Total|Total of all reporting groups
11103714|NCT01605136|FG000|Participant Flow|Afamelanotide|"One 16mg subcutaneous implant every 2 months for 6 months.~Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months."
11103715|NCT01605136|FG001|Participant Flow|Placebo|"One placebo subcutaneous implant every 2 months for 6 months.~Placebo: One placebo subcutaneous implant every 2 months for 6 months"
11103716|NCT01605136|OG000|Outcome|Afamelanotide|Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months.
11103717|NCT01605136|OG001|Outcome|Placebo|Placebo: One placebo subcutaneous implant every 2 months for 6 months
11103718|NCT01605136|EG000|Reported Event|Afamelanotide|"One 16mg subcutaneous implant every 2 months for 6 months.~Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months."
11103719|NCT01605136|EG001|Reported Event|Placebo|"One placebo subcutaneous implant every 2 months for 6 months.~Placebo: One placebo subcutaneous implant every 2 months for 6 months"
11103720|NCT01605227|BG000|Baseline|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
11103721|NCT01605227|BG001|Baseline|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
11103722|NCT01605227|BG002|Baseline|Total|Total of all reporting groups
11103723|NCT01605227|FG000|Participant Flow|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
11103724|NCT01605227|FG001|Participant Flow|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
11103725|NCT01605227|OG000|Outcome|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
11103726|NCT01605227|OG001|Outcome|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
11103727|NCT01605227|EG000|Reported Event|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
11103728|NCT01605227|EG001|Reported Event|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
11103729|NCT01605292|BG000|Baseline|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
11103730|NCT01605292|BG001|Baseline|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
11103731|NCT01605292|BG002|Baseline|Total|Total of all reporting groups
11103732|NCT01605292|FG000|Participant Flow|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
11103733|NCT01605292|FG001|Participant Flow|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
11103734|NCT01605292|OG000|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
11103735|NCT01605292|OG001|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
11103736|NCT01605292|EG000|Reported Event|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
11103737|NCT01605292|EG001|Reported Event|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
11103738|NCT01605396|BG000|Baseline|Ridaforolimus + Dalotuzumab + Exemestane|Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.
11103739|NCT01605396|BG001|Baseline|Ridaforolimus + Exemestane|Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
11103740|NCT01605396|BG002|Baseline|Total|Total of all reporting groups
11103741|NCT01605396|FG000|Participant Flow|Ridaforolimus + Dalotuzumab + Exemestane|Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.
11103742|NCT01605396|FG001|Participant Flow|Ridaforolimus + Exemestane|Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
11103743|NCT01605396|OG000|Outcome|Ridaforolimus + Dalotuzumab + Exemestane|Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.
11103744|NCT01605396|OG001|Outcome|Ridaforolimus + Exemestane|Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
11103745|NCT01605396|EG000|Reported Event|Ridaforolimus + Dalotuzumab + Exemestane|Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.
11103746|NCT01605396|EG001|Reported Event|Ridaforolimus + Exemestane|Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
11224510|NCT02360475|FG002|Participant Flow|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11103747|NCT01605435|BG000|Baseline|Ghrelin|"Dose finding with each participant receiving placebo and three doses of ghrelin, separated by 3-7 days~Ghrelin: The first three participants will receive 2 mcg/kg as a single subcutaneous dose at Visit 3, 5 mcg/kg as a single subcutaneous dose at Visit 4, and 10 mcg/Kg as a single subcutaneous dose at visit 5. There will be 3-10 days between visits. The next three participants will receive either the same dosing at the first three, a regimen that includes an intermediate dose (e.g., 7.5 mcg/kg), or higher (e.g., 12, 15, and 18 mcg/kg) doses."
11103748|NCT01605435|FG000|Participant Flow|Initial Dosing Group|Visit 1: Placebo Visit 2: 2 ug/kg ghrelin Visit 3: 5 ug/kg ghrelin Visit 4: 10 ug/kg ghrelin
11103749|NCT01605435|FG001|Participant Flow|Second Dosing Group|Visit 1: Placebo Visit 2: 5 ug/kg ghrelin Visit 3: 7.5 ug/kg ghrelin Visit 4: 10 ug/kg ghrelin
11103750|NCT01605435|OG000|Outcome|Placebo|All 5 subjects received s.c. placebo at visit 1.
11103751|NCT01605435|OG001|Outcome|2ug/kg|The first two participants received 2ug/kg of s.c. ghrelin at visit 2.
11103752|NCT01605435|OG002|Outcome|5ug/kg|The first two participants received 5ug/kg of s.c. ghrelin at visit 3. The final three participants received 5ug/kg of s.c. ghrelin at visits 2.
11103753|NCT01605435|OG003|Outcome|7.5ug/kg|The final three participants received 7.5ug/kg of s.c. ghrelin at visit 3.
11103754|NCT01605435|OG004|Outcome|10ug/kg|The first two participants received 10ug/kg of s.c. ghrelin at visit 4. The final three participants received 10ug/kg of s.c. ghrelin at visit 4.
11103755|NCT01605435|OG001|Outcome|2 mcg/kg|The first two participants received 2ug/kg of s.c. ghrelin at visit 2.
11103756|NCT01605435|OG002|Outcome|5mcg/kg|The first two participants received 5ug/kg of s.c. ghrelin at visit 3. The final three participants received 5ug/kg of s.c. ghrelin at visits 2.
11103757|NCT01605435|OG003|Outcome|7.5mcg/kg|The final three participants received 7.5ug/kg of s.c. ghrelin at visit 3.
11103758|NCT01605435|OG004|Outcome|10mcg/kg|The first two participants received 10ug/kg of s.c. ghrelin at visit 4. The final three participants received 10ug/kg of s.c. ghrelin at visit 4.
11103759|NCT01605435|OG001|Outcome|2mcg/kg|The first two participants received 2ug/kg of s.c. ghrelin at visit 2.
11103760|NCT01605435|EG000|Reported Event|Placebo|Visit 1 for all five subjects placebo injected s.c. at time 0
11103761|NCT01605435|EG001|Reported Event|2mcg/kg|Visit 2 for the first two subjects 2mcg/kg ghrelin injected s.c at time 0
11103762|NCT01605435|EG002|Reported Event|5mcg/kg|Visit 3 for the first two subjects Visit 2 for the last three subjects 5mcg/kg ghrelin injected s.c. at time 0
11103763|NCT01605435|EG003|Reported Event|7.5mcg/kg|Visit 3 for the last three subjects 7.5mcg/kg ghrelin injected at time 0
11103764|NCT01605435|EG004|Reported Event|10mcg/kg|Visit 4 for all five subjects
11103765|NCT01605461|BG000|Baseline|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
11103766|NCT01605461|FG000|Participant Flow|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
11103767|NCT01605461|OG000|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
11103768|NCT01605461|EG000|Reported Event|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
11103769|NCT01605539|BG000|Baseline|Control|"Subjects received pills that resemble the Cannabidiol capsule but did not have its properties.~Control: Subjects receivd a harmless, inactive pill to compare and validate the results of the other arms of the study"
11103770|NCT01605539|BG001|Baseline|CBD Group|"The two arms (400 mg and 800 mg of Cannabidiol) were combined for analysis because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
11103771|NCT01605539|BG002|Baseline|Total|Total of all reporting groups
11103772|NCT01605539|FG000|Participant Flow|Control|"Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study"
11103773|NCT01605539|FG001|Participant Flow|CBD 400 Group|"Subjects will receive 400 mg of cannabidiol~Subjects in Arm CBD 400 will receive 400 mg of Cannabidiol in each of the three test sessions"
11103774|NCT01605539|FG002|Participant Flow|CBD 800 Group|Subjects in Arm CBD 800 will receive 800 mg of Cannabidiol in each of the three test sessions
11103775|NCT01605539|OG000|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
11103776|NCT01605539|OG001|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
11103777|NCT01605539|OG000|Outcome|Control|"Subjects received pills that resembled the Cannabidiol capsule but did not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
11103778|NCT01605539|OG001|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD will receive 400 mg or 800mg of Cannabidiol in each of the three test sessions"
11103779|NCT01605539|OG001|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
11103780|NCT01605539|EG000|Reported Event|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
11103781|NCT01605539|EG001|Reported Event|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
11103782|NCT01605552|BG000|Baseline|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
11103783|NCT01605552|BG001|Baseline|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
11103784|NCT01605552|BG002|Baseline|Total|Total of all reporting groups
11103785|NCT01605552|FG000|Participant Flow|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
11103786|NCT01605552|FG001|Participant Flow|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
11103787|NCT01605552|OG000|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
11103788|NCT01605552|OG001|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
11103789|NCT01605552|EG000|Reported Event|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
11103790|NCT01605552|EG001|Reported Event|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
11103791|NCT01605669|BG000|Baseline|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
11103792|NCT01605669|FG000|Participant Flow|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
11103793|NCT01605669|OG000|Outcome|Mean Pressure Gradient >=30mmHg (Positive)|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
11103794|NCT01605669|OG001|Outcome|Mean Pressure Gradient <30mmHg (Negative)|
11103795|NCT01605669|EG000|Reported Event|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
11103796|NCT01605799|BG000|Baseline|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
11103797|NCT01605799|BG001|Baseline|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
11103798|NCT01605799|BG002|Baseline|Total|Total of all reporting groups
11103799|NCT01605799|FG000|Participant Flow|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
11103800|NCT01605799|FG001|Participant Flow|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
11103801|NCT01605799|OG000|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
11103802|NCT01605799|OG001|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
11103803|NCT01605799|EG000|Reported Event|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
11103804|NCT01605799|EG001|Reported Event|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
11103805|NCT01605825|BG000|Baseline|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
11103806|NCT01605825|BG001|Baseline|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
11103807|NCT01605825|BG002|Baseline|Total|Total of all reporting groups
11103808|NCT01605825|FG000|Participant Flow|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
11103809|NCT01605825|FG001|Participant Flow|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
11103810|NCT01605825|OG000|Outcome|Placebo|
11103811|NCT01605825|OG001|Outcome|Dalfampridine-ER|
11103812|NCT01605825|EG000|Reported Event|Placebo|
11103813|NCT01605825|EG001|Reported Event|Dalfampridine-ER|
11103814|NCT01605877|BG000|Baseline|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
11103815|NCT01605877|FG000|Participant Flow|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
11103816|NCT01605877|OG000|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103817|NCT01605877|OG001|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103818|NCT01605877|OG002|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103819|NCT01605877|OG003|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103820|NCT01605877|OG004|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103821|NCT01605877|OG005|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103822|NCT01605877|OG001|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103823|NCT01605877|OG002|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103824|NCT01605877|OG003|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103825|NCT01605877|OG000|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103826|NCT01605877|OG001|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103827|NCT01605877|OG000|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103828|NCT01605877|OG001|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103829|NCT01605877|OG002|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103830|NCT01605877|OG003|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103831|NCT01605877|OG004|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103832|NCT01605877|OG000|Outcome|SN6AD2, as Measured With CSV-1000|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103833|NCT01605877|OG001|Outcome|SN6AD2, as Measured With VCTS|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103834|NCT01605877|OG000|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
11103835|NCT01605877|EG000|Reported Event|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
11103836|NCT01605890|BG000|Baseline|Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate|"emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.~raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID."
11103837|NCT01605890|FG000|Participant Flow|Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate|"emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.~raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID."
11103838|NCT01605890|OG000|Outcome|Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate|"emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.~raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID."
11103839|NCT01605890|EG000|Reported Event|Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate|"emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.~raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID."
11103840|NCT01605903|BG000|Baseline|Treatment With Ibuprofen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.~Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
11103841|NCT01605903|BG001|Baseline|Treatment With Acetaminophen|"Children will be randomly assigned to either the treatment arm or active comparator prior to surgery. Children in the active comparator group (Acetaminophen) will receive grape flavored 160 mg/5 ml acetaminophen. Acetaminophen will be dispensed at 15 mg/kg (max dose 650/mg) Q6.~Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
11103842|NCT01605903|BG002|Baseline|Total|Total of all reporting groups
11103843|NCT01605903|FG000|Participant Flow|Treatment With Ibuprofen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
11103844|NCT01605903|FG001|Participant Flow|Treatment With Acetaminophen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
11103845|NCT01605903|OG000|Outcome|Treatment With Ibuprofen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
11103846|NCT01605903|OG001|Outcome|Treatment With Acetaminophen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
11103847|NCT01605903|EG000|Reported Event|Treatment With Ibuprofen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
11103848|NCT01605903|EG001|Reported Event|Treatment With Acetaminophen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
11103849|NCT01605916|BG000|Baseline|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
11103850|NCT01605916|BG001|Baseline|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
11103851|NCT01605916|BG002|Baseline|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
11103852|NCT01605916|BG003|Baseline|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
11103853|NCT01605916|BG004|Baseline|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
11103854|NCT01605916|BG005|Baseline|Total|Total of all reporting groups
11103855|NCT01605916|FG000|Participant Flow|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
11103856|NCT01605916|FG001|Participant Flow|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
11103857|NCT01605916|FG002|Participant Flow|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
11103858|NCT01605916|FG003|Participant Flow|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
11103859|NCT01605916|FG004|Participant Flow|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
11103860|NCT01605916|OG000|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
11103861|NCT01605916|OG001|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
11103862|NCT01605916|OG002|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
11103863|NCT01605916|OG003|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
11103864|NCT01605916|OG004|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
11103865|NCT01605916|OG004|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
11103866|NCT01605916|EG000|Reported Event|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
11103867|NCT01605916|EG001|Reported Event|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
11103868|NCT01605916|EG002|Reported Event|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
11103869|NCT01605916|EG003|Reported Event|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
11103870|NCT01605916|EG004|Reported Event|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
11103871|NCT01605942|BG000|Baseline|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
11103872|NCT01605942|BG001|Baseline|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
11103873|NCT01605942|BG002|Baseline|Total|Total of all reporting groups
11103874|NCT01605942|FG000|Participant Flow|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
11103875|NCT01605942|FG001|Participant Flow|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
11103876|NCT01605942|OG000|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
11103877|NCT01605942|OG001|Outcome|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
11103878|NCT01605942|EG000|Reported Event|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
11103879|NCT01605942|EG001|Reported Event|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
11103880|NCT01606007|BG000|Baseline|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
11103881|NCT01606007|BG001|Baseline|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
11103882|NCT01606007|BG002|Baseline|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
11103883|NCT01606007|BG003|Baseline|Total|Total of all reporting groups
11103884|NCT01606007|FG000|Participant Flow|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
11103885|NCT01606007|FG001|Participant Flow|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
11103886|NCT01606007|FG002|Participant Flow|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
11103887|NCT01606007|OG000|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
11103888|NCT01606007|OG001|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
11103889|NCT01606007|OG002|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
11103890|NCT01606007|EG000|Reported Event|SAXA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
11103891|NCT01606007|EG001|Reported Event|DAPA + MET|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
11103892|NCT01606007|EG002|Reported Event|SAXA + DAPA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
11103893|NCT01606124|BG000|Baseline|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
11103894|NCT01606124|BG001|Baseline|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
11103895|NCT01606124|BG002|Baseline|Total|Total of all reporting groups
11103896|NCT01606124|FG000|Participant Flow|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
11103897|NCT01606124|FG001|Participant Flow|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
11103898|NCT01606124|OG000|Outcome|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
11103899|NCT01606124|OG001|Outcome|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
11103900|NCT01606124|EG000|Reported Event|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
11103901|NCT01606124|EG001|Reported Event|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
11103902|NCT01606137|BG000|Baseline|GW-1000-02|Active treatment
11103903|NCT01606137|FG000|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
11103904|NCT01606137|OG000|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
11103905|NCT01606137|EG000|Reported Event|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
11103906|NCT01606176|BG000|Baseline|GW-1000-02|Active treatment.
11103907|NCT01606176|BG001|Baseline|Placebo|Placebo control.
11103908|NCT01606176|BG002|Baseline|Total|Total of all reporting groups
11103909|NCT01606176|FG000|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg).
11103910|NCT01606176|FG001|Participant Flow|Placebo|Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
11103911|NCT01606176|OG000|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
11103912|NCT01606176|OG001|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
11103913|NCT01606176|EG000|Reported Event|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
11103914|NCT01606176|EG001|Reported Event|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
11103915|NCT01606189|BG000|Baseline|All Study Treatments: GW-1000-02, GW-2000-02 and Placebo|As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo.
11103916|NCT01606189|FG000|Participant Flow|GW-1000-02 First, Then GW-2000-02, Then Placebo|"GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
11103917|NCT01606189|FG001|Participant Flow|GW-2000-02 First, Then GW-1000-02, Then Placebo|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
11103918|NCT01606189|FG002|Participant Flow|Placebo First, Then GW-1000-02, Then GW-2000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
11103919|NCT01606189|FG003|Participant Flow|GW-1000-02 First, Then Placebo, Then GW-2000-02|"GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
11103920|NCT01606189|FG004|Participant Flow|Placebo First, Then GW-2000-02, Then GW-1000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
11103921|NCT01606189|FG005|Participant Flow|GW-2000-02 First, Then Placebo, Then GW-1000-02|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
11103922|NCT01606189|OG000|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
11103923|NCT01606189|OG001|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
11103924|NCT01606189|OG002|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
11103925|NCT01606189|EG000|Reported Event|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
11103926|NCT01606189|EG001|Reported Event|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
11103927|NCT01606189|EG002|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
11103928|NCT01606202|BG000|Baseline|GW-1000-02|Active treatment.
11103929|NCT01606202|BG001|Baseline|Placebo|Placebo control.
11103930|NCT01606202|BG002|Baseline|Total|Total of all reporting groups
11103931|NCT01606202|FG000|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
11103932|NCT01606202|FG001|Participant Flow|Placebo|Placebo control.The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
11103933|NCT01606202|OG000|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11103934|NCT01606202|OG001|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
11103935|NCT01606202|EG000|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11103936|NCT01606202|EG001|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
11103937|NCT01606228|BG000|Baseline|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
11103938|NCT01606228|FG000|Participant Flow|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
11103939|NCT01606228|OG000|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
11103940|NCT01606228|EG000|Reported Event|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
11103941|NCT01606254|BG000|Baseline|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
11103942|NCT01606254|BG001|Baseline|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
11103943|NCT01606254|BG002|Baseline|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
11103944|NCT01606254|BG003|Baseline|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
11103945|NCT01606254|BG004|Baseline|Total|Total of all reporting groups
11103946|NCT01606254|FG000|Participant Flow|Paliperidone Palmitate 50 mg|Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64.
11103947|NCT01606254|FG001|Participant Flow|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
11103948|NCT01606254|FG002|Participant Flow|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
11103949|NCT01606254|FG003|Participant Flow|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
11103950|NCT01606254|OG000|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
11103951|NCT01606254|OG001|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
11103952|NCT01606254|OG002|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
11103953|NCT01606254|OG003|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
11103954|NCT01606254|EG000|Reported Event|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
11103955|NCT01606254|EG001|Reported Event|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
11103956|NCT01606254|EG002|Reported Event|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
11103957|NCT01606254|EG003|Reported Event|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
11103958|NCT01606306|BG000|Baseline|Crossover Sequence 1|daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
11103959|NCT01606306|BG001|Baseline|Crossover Sequence 2|daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
11103960|NCT01606306|BG002|Baseline|Crossover Sequence 3|daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
11103961|NCT01606306|BG003|Baseline|Crossover Sequence 4|daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
11103962|NCT01606306|BG004|Baseline|Crossover Sequence 5|as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
11103963|NCT01606306|BG005|Baseline|Crossover Sequence 6|as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
11103964|NCT01606306|BG006|Baseline|Total|Total of all reporting groups
11103965|NCT01606306|FG000|Participant Flow|Crossover Sequence 1|daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
11103966|NCT01606306|FG001|Participant Flow|Crossover Sequence 2|daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
11103967|NCT01606306|FG002|Participant Flow|Crossover Sequence 3|daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
11103968|NCT01606306|FG003|Participant Flow|Crossover Sequence 4|daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
11103969|NCT01606306|FG004|Participant Flow|Crossover Sequence 5|as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
11103970|NCT01606306|FG005|Participant Flow|Crossover Sequence 6|as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
11103971|NCT01606306|OG000|Outcome|All Evaluable Participants|Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period. Because placebo washouts were not performed, the data collected during the first two weeks of each period were not included in the analysis of ACDs. Days with missing diary data were also excluded from ACD determination.
11103972|NCT01606306|EG000|Reported Event|Daily ICS|Daily inhaled corticosteroid (ICS) treatment
11103973|NCT01606306|EG001|Reported Event|As-needed ICS|As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.
11103974|NCT01606306|EG002|Reported Event|Daily LTRA|Daily leukotriene receptor antagonist (LTRA) treatment
11103975|NCT01606319|BG000|Baseline|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
11103976|NCT01606319|BG001|Baseline|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
11103977|NCT01606319|BG002|Baseline|Total|Total of all reporting groups
11103978|NCT01606319|FG000|Participant Flow|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
11103979|NCT01606319|FG001|Participant Flow|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
11103980|NCT01606319|OG000|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
11103981|NCT01606319|OG001|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
11103982|NCT01606319|EG000|Reported Event|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
11103983|NCT01606319|EG001|Reported Event|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
11103984|NCT01606670|BG000|Baseline|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
11103985|NCT01606670|FG000|Participant Flow|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
11103986|NCT01606670|OG000|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
11103987|NCT01606670|EG000|Reported Event|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
11103988|NCT01606735|BG000|Baseline|342 mcg|IBI-10090: dexamethasone
11103989|NCT01606735|BG001|Baseline|517 mcg|IBI-10090: dexamethasone
11103990|NCT01606735|BG002|Baseline|697 mcg|IBI-10090: dexamethasone
11103991|NCT01606735|BG003|Baseline|Total|Total of all reporting groups
11103992|NCT01606735|FG000|Participant Flow|342 mcg|IBI-10090: dexamethasone
11103993|NCT01606735|FG001|Participant Flow|517 mcg|IBI-10090: dexamethasone
11103994|NCT01606735|FG002|Participant Flow|697 mcg|IBI-10090: dexamethasone
11103995|NCT01606735|OG000|Outcome|342 mcg|IBI-10090: dexamethasone
11103996|NCT01606735|OG001|Outcome|517 mcg|IBI-10090: dexamethasone
11103997|NCT01606735|OG002|Outcome|697 mcg|IBI-10090: dexamethasone
11103998|NCT01606735|EG000|Reported Event|342 mcg|IBI-10090: dexamethasone
11103999|NCT01606735|EG001|Reported Event|517 mcg|IBI-10090: dexamethasone
11104000|NCT01606735|EG002|Reported Event|697 mcg|IBI-10090: dexamethasone
11126487|NCT01733680|OG000|Outcome|Amiloride|"Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.~Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.~amiloride: Subjects will take either amiloride hydrochloride or placebo for 8 weeks.~Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement"
11126488|NCT01733680|OG001|Outcome|Placebo|"Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI~Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement"
11126489|NCT01733680|OG000|Outcome|Arm 1-Amiloride|Amiloride was administered for 8 weeks. 5 mg for 2 weeks, 10 mg for 3 weeks and 15 mg for 3 weeks
11126490|NCT01733680|OG001|Outcome|Arm 2-Placebo|Subjects were given placebo for 8 weeks
11126491|NCT01733680|OG000|Outcome|Arm 1-Amiloride|Subjects received amiloride hydrochloride for 8 weeks. 5 mg/day for 2 weeks, 10 mg/day for 3 weeks, and 15 mg/day for 3 weeks.
11126492|NCT01733680|OG001|Outcome|Arm 2-Placebo|Subjects received placebo for 8 weeks
11126493|NCT01733680|EG000|Reported Event|Amiloride|"Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.~Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.~amiloride: Subjects will take either amiloride hydrochloride or placebo for 8 weeks.~Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement"
11126494|NCT01733680|EG001|Reported Event|Placebo|"Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI~Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement"
11126495|NCT01733732|BG000|Baseline|Systane Balance|One drop in each eye 4 times a day for 30 days
11126496|NCT01733732|BG001|Baseline|Systane Gel|One drop in each eye 4 times a day for 30 days
11126497|NCT01733732|BG002|Baseline|Total|Total of all reporting groups
11126498|NCT01733732|FG000|Participant Flow|Systane Balance|One drop in each eye 4 times a day for 30 days
11126499|NCT01733732|FG001|Participant Flow|Systane Gel|One drop in each eye 4 times a day for 30 days
11126500|NCT01733732|OG000|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
11126501|NCT01733732|OG001|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
11126502|NCT01733732|OG000|Outcome|Systane Balance, Day 0|One drop in each eye 4 times a day for 30 days
11126503|NCT01733732|OG001|Outcome|Systane Balance, Day 14|One drop in each eye 4 times a day for 30 days
11126504|NCT01733732|OG002|Outcome|Systane Balance, Day 30|One drop in each eye 4 times a day for 30 days
11126505|NCT01733732|OG003|Outcome|Systane Gel, Day 0|One drop in each eye 4 times a day for 30 days
11126506|NCT01733732|OG004|Outcome|Systane Gel, Day 14|One drop in each eye 4 times a day for 30 days
11126507|NCT01733732|OG005|Outcome|Systane Gel, Day 30|One drop in each eye 4 times a day for 30 days
11126508|NCT01733732|OG000|Outcome|Systane Balance, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
11126509|NCT01733732|OG001|Outcome|Systane Balance, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
11126510|NCT01733732|OG002|Outcome|Systane Gel, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
11126511|NCT01733732|OG003|Outcome|Systane Gel, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
11126512|NCT01733732|EG000|Reported Event|Systane Balance|One drop in each eye 4 times a day for 30 days
11126513|NCT01733732|EG001|Reported Event|Systane Gel|One drop in each eye 4 times a day for 30 days
11126514|NCT01733745|BG000|Baseline|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
11126515|NCT01733745|BG001|Baseline|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
11104001|NCT01606748|BG000|Baseline|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104002|NCT01606748|BG001|Baseline|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104003|NCT01606748|BG002|Baseline|Total|Total of all reporting groups
11104004|NCT01606748|FG000|Participant Flow|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (IV) infusion at an absolute dose of 800 milligrams (mg). Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/square meter (m2).~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104005|NCT01606748|FG001|Participant Flow|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab drug product manufactured using a new and comparable necitumumab drug substance (Process D drug product).~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104006|NCT01606748|OG000|Outcome|Necitumumab Cohort 1 Day 3 Run-in|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
11104007|NCT01606748|OG001|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
11104008|NCT01606748|OG000|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-In|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
11104009|NCT01606748|OG001|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
11104010|NCT01606748|OG000|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
11104011|NCT01606748|OG001|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
11104012|NCT01606748|OG000|Outcome|Necitumumab Cohort 1 Day 3 Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
11104013|NCT01606748|OG001|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
11104014|NCT01606748|OG000|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104015|NCT01606748|OG001|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104016|NCT01606748|OG000|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104017|NCT01606748|OG001|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104018|NCT01606748|OG000|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
11104019|NCT01606748|OG000|Outcome|Necitumumab Cohort 1 Day 3 PK Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
11126516|NCT01733745|BG002|Baseline|Total|Total of all reporting groups
11126517|NCT01733745|FG000|Participant Flow|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
11104020|NCT01606748|EG000|Reported Event|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104021|NCT01606748|EG001|Reported Event|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
11104022|NCT01606761|BG000|Baseline|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.
11104023|NCT01606761|BG001|Baseline|Sirukumab 50 mg q4w|All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104024|NCT01606761|BG002|Baseline|Sirukumab 100 mg q2w|All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104025|NCT01606761|BG003|Baseline|Total|Total of all reporting groups
11104026|NCT01606761|FG000|Participant Flow|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.
11104027|NCT01606761|FG001|Participant Flow|Sirukumab 50 mg q4w|All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104028|NCT01606761|FG002|Participant Flow|Sirukumab 100 mg q2w|All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104029|NCT01606761|FG003|Participant Flow|Placebo to 50 mg q4w Due to EE or CO|Participants who received matching placebo in the placebo controlled period were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104030|NCT01606761|FG004|Participant Flow|Placebo to 100 mg q2w Due to EE or CO|Participants who received matching placebo in the placebo controlled period were re-randomized (due to EE at Week 18 or CO at Week 24) to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104031|NCT01606761|OG000|Outcome|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
11104032|NCT01606761|OG001|Outcome|Sirukumab 50 mg|Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
11104033|NCT01606761|OG002|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
11104034|NCT01606761|EG000|Reported Event|Week (W) 24-Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossover (CO) at Week 24.
11104035|NCT01606761|EG001|Reported Event|W24 to W52-Placebo to 50 mg q4w Due to EE or CO|Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 52.
11104036|NCT01606761|EG002|Reported Event|W52-Sirukumab 50 mg q4w|Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
11104037|NCT01606761|EG003|Reported Event|W24 to W52-Placebo to 100 mg q2w Due to EE or CO|Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 100 mg q4w dose regimen up to Week 52.
10846746|NCT00279708|BG001|Baseline|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
11104038|NCT01606761|EG004|Reported Event|W52-Sirukumab 100 mg q2w|Participants received sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 52.
11104039|NCT01606761|EG005|Reported Event|W52 to W68-Placebo|Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104040|NCT01606761|EG006|Reported Event|W52 to W68-Placebo to 50 mg q4w Due to EE or CO|Participants who discontinued or completed sirukumab 50 mg q4w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104041|NCT01606761|EG007|Reported Event|W52 to W68-Sirukumab 50 mg q4w|Participants who discontinued or completed sirukumab 50 mg q4w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104042|NCT01606761|EG008|Reported Event|W52 to W68-Placebo to 100 mg q2w Due to EE or CO|Participants who discontinued or completed sirukumab 100 mg q2w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104043|NCT01606761|EG009|Reported Event|W52 to W68-Sirukumab 100 mg q2w|Participants who discontinued or completed sirukumab 100 mg q2w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
11104044|NCT01606787|BG000|Baseline|Mannitol Arm|"This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.~mannitol: After induction of general anesthesia Normosol or Lactated Ringers , at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The treatment arm will receive a standard dose of 12.5 grams of mannitol (200 cc of a 6.25% mannitol solution) intravenously completely infused through an existing intravenous access catheter within 30 minutes prior to renal artery clamping."
11104045|NCT01606787|BG001|Baseline|Placebo Arm|"This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.~placebo: After induction of general anesthesia Normosol or Lactated Ringers at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The placebo arm will receive 200cc of normal saline completely infused within 30 minutes prior to renal artery clamping."
11104046|NCT01606787|BG002|Baseline|Total|Total of all reporting groups
11104047|NCT01606787|FG000|Participant Flow|Mannitol Arm|"This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.~mannitol: After induction of general anesthesia Normosol or Lactated Ringers , at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The treatment arm will receive a standard dose of 12.5 grams of mannitol (200 cc of a 6.25% mannitol solution) intravenously completely infused through an existing intravenous access catheter within 30 minutes prior to renal artery clamping."
11104048|NCT01606787|FG001|Participant Flow|Placebo Arm|"This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.~placebo: After induction of general anesthesia Normosol or Lactated Ringers at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The placebo arm will receive 200cc of normal saline completely infused within 30 minutes prior to renal artery clamping."
11104049|NCT01606787|OG000|Outcome|Mannitol Arm|"This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.~mannitol: After induction of general anesthesia Normosol or Lactated Ringers , at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The treatment arm will receive a standard dose of 12.5 grams of mannitol (200 cc of a 6.25% mannitol solution) intravenously completely infused through an existing intravenous access catheter within 30 minutes prior to renal artery clamping."
11104050|NCT01606787|OG001|Outcome|Placebo Arm|"This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.~placebo: After induction of general anesthesia Normosol or Lactated Ringers at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The placebo arm will receive 200cc of normal saline completely infused within 30 minutes prior to renal artery clamping."
11104051|NCT01606787|EG000|Reported Event|Mannitol Arm|"This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.~mannitol: After induction of general anesthesia Normosol or Lactated Ringers , at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The treatment arm will receive a standard dose of 12.5 grams of mannitol (200 cc of a 6.25% mannitol solution) intravenously completely infused through an existing intravenous access catheter within 30 minutes prior to renal artery clamping."
11104052|NCT01606787|EG001|Reported Event|Placebo Arm|"This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.~placebo: After induction of general anesthesia Normosol or Lactated Ringers at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The placebo arm will receive 200cc of normal saline completely infused within 30 minutes prior to renal artery clamping."
11104053|NCT01606800|BG000|Baseline|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
11104054|NCT01606800|BG001|Baseline|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
11104055|NCT01606800|BG002|Baseline|Total|Total of all reporting groups
11104056|NCT01606800|FG000|Participant Flow|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
11104057|NCT01606800|FG001|Participant Flow|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
11104058|NCT01606800|OG000|Outcome|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
11104059|NCT01606800|OG001|Outcome|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
11104060|NCT01606800|EG000|Reported Event|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
11104061|NCT01606800|EG001|Reported Event|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
11104062|NCT01606852|BG000|Baseline|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
11104063|NCT01606852|BG001|Baseline|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
11104064|NCT01606852|BG002|Baseline|Total|Total of all reporting groups
11104065|NCT01606852|FG000|Participant Flow|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
11104066|NCT01606852|FG001|Participant Flow|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
11104067|NCT01606852|OG000|Outcome|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
11126518|NCT01733745|FG001|Participant Flow|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
11126519|NCT01733745|OG000|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
10846747|NCT00279708|BG002|Baseline|Total|Total of all reporting groups
11104068|NCT01606852|OG001|Outcome|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
11104069|NCT01606852|EG000|Reported Event|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
11104070|NCT01606852|EG001|Reported Event|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
11104071|NCT01607073|BG000|Baseline|Open Label Adjunctive Add on|"open label adjunctive add on of verapamil to existing medications. dosing begins at 1 mg/kg/d and increases weekly to target of 4 mg/kg/d in divided doses (three times/day)~Verapamil: Verapamil will be prepared as a solution. A 50mg/ml oral suspension may be made with immediate release tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus will be used.~Children will start on a 4 weeks titration period:~Week 1: 1mg/kg/day divided BID Week 2: 2mg/kg/day divided BID or TID Week 3: 3mg/kg/day divided BID or TID Week 4: 4mg/kg/day divided TID~In event of adverse events, and in consultation with the family and treating physician, the dosage may be decreased to 2mg/kg/day and remain at that dose for the remainder of the study."
11104072|NCT01607073|FG000|Participant Flow|Adjunctive Verapamil|Participants taking verapamil for Dravet syndrome
11104073|NCT01607073|OG000|Outcome|Week 8 Baseline|Week 8 visit - 8 weeks of baseline seizure data collected
11104074|NCT01607073|OG001|Outcome|Week 12 Verapamil 4mg/kg/Day|Participants have titrated up to 4mg/kg/day of verapamil
11104075|NCT01607073|OG000|Outcome|Week 8 Baseline|Collected number of seizures at baseline before participants were taking verapamil.
11104076|NCT01607073|OG001|Outcome|Week 12 Verapamil 4mg/kg/Day|Participants taking verapamil for 4 weeks post baseline.
11104077|NCT01607073|EG000|Reported Event|Open Label Adjunctive Add on|"open label adjunctive add on of verapamil to existing medications. dosing begins at 1 mg/kg/d and increases weekly to target of 4 mg/kg/d in divided doses (three times/day)~Verapamil: Verapamil will be prepared as a solution. A 50mg/ml oral suspension may be made with immediate release tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus will be used.~Children will start on a 4 weeks titration period:~Week 1: 1mg/kg/day divided BID Week 2: 2mg/kg/day divided BID or TID Week 3: 3mg/kg/day divided BID or TID Week 4: 4mg/kg/day divided TID~In event of adverse events, and in consultation with the family and treating physician, the dosage may be decreased to 2mg/kg/day and remain at that dose for the remainder of the study."
11104078|NCT01607112|BG000|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104079|NCT01607112|BG001|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104080|NCT01607112|BG002|Baseline|Total|Total of all reporting groups
11104081|NCT01607112|FG000|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104082|NCT01607112|FG001|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104083|NCT01607112|OG000|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104084|NCT01607112|OG001|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104085|NCT01607112|OG000|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104086|NCT01607112|OG001|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104087|NCT01607112|OG000|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104088|NCT01607112|OG001|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104089|NCT01607112|EG000|Reported Event|Adult Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104090|NCT01607112|EG001|Reported Event|Elderly Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11104091|NCT01607203|BG000|Baseline|HCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
11104092|NCT01607203|BG001|Baseline|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
11104093|NCT01607203|BG002|Baseline|Total|Total of all reporting groups
11104094|NCT01607203|FG000|Participant Flow|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
11104095|NCT01607203|FG001|Participant Flow|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
11104096|NCT01607203|OG000|Outcome|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
11104097|NCT01607203|OG001|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
11104098|NCT01607203|OG000|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
11104099|NCT01607203|EG000|Reported Event|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
11104100|NCT01607203|EG001|Reported Event|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
11104101|NCT01607255|BG000|Baseline|Water (Exchange) Method|"Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.~water (exchange) method: Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions."
11104102|NCT01607255|BG001|Baseline|Water (Exchange) Plus Dye Method|"Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions~Indigo carmine: 0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy~water (exchange) plus dye method: Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions"
11104103|NCT01607255|BG002|Baseline|Air Method|"The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.~air method: The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated."
11104104|NCT01607255|BG003|Baseline|Total|Total of all reporting groups
11104105|NCT01607255|FG000|Participant Flow|Water (Exchange) Method|"Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.~water (exchange) method: Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions."
11104106|NCT01607255|FG001|Participant Flow|Water (Exchange) Plus Dye Method|"Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions~Indigo carmine: 0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy~water (exchange) plus dye method: Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions"
11126520|NCT01733745|OG001|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
11126521|NCT01733745|EG000|Reported Event|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
11104107|NCT01607255|FG002|Participant Flow|Air Method|"The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.~air method: The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated."
11104108|NCT01607255|OG000|Outcome|Water (Exchange) Method|"Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.~water (exchange) method: Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions."
11104109|NCT01607255|OG001|Outcome|Water (Exchange) Plus Dye Method|"Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions~Indigo carmine: 0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy~water (exchange) plus dye method: Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions"
11104110|NCT01607255|OG002|Outcome|Air Method|"The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.~air method: The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated."
11104111|NCT01607255|EG000|Reported Event|Water (Exchange) Method|"Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.~water (exchange) method: Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions."
11104112|NCT01607255|EG001|Reported Event|Water (Exchange) Plus Dye Method|"Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions~Indigo carmine: 0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy~water (exchange) plus dye method: Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions"
11104113|NCT01607255|EG002|Reported Event|Air Method|"The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.~air method: The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated."
11104114|NCT01607346|BG000|Baseline|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
11104115|NCT01607346|FG000|Participant Flow|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
11104116|NCT01607346|OG000|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
11104117|NCT01607346|EG000|Reported Event|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
11104118|NCT01607398|BG000|Baseline|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
11104119|NCT01607398|BG001|Baseline|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
11104120|NCT01607398|BG002|Baseline|Total|Total of all reporting groups
11104121|NCT01607398|FG000|Participant Flow|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
11104122|NCT01607398|FG001|Participant Flow|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
11104123|NCT01607398|OG000|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
11104124|NCT01607398|OG001|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
11104125|NCT01607398|EG000|Reported Event|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
11104126|NCT01607398|EG001|Reported Event|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
11104127|NCT01607411|BG000|Baseline|Overall|All randomized participants who received atleast one dose of the study treatments
11104128|NCT01607411|FG000|Participant Flow|Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 grams (g) ± 0.1g of NaF toothpaste(1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104129|NCT01607411|FG001|Participant Flow|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104130|NCT01607411|FG002|Participant Flow|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104131|NCT01607411|FG003|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104132|NCT01607411|OG000|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104133|NCT01607411|OG001|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104134|NCT01607411|OG002|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104135|NCT01607411|OG003|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104136|NCT01607411|EG000|Reported Event|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104137|NCT01607411|EG001|Reported Event|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104138|NCT01607411|EG002|Reported Event|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104139|NCT01607411|EG003|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
11104140|NCT01607450|BG000|Baseline|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
11104141|NCT01607450|BG001|Baseline|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104142|NCT01607450|BG002|Baseline|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104143|NCT01607450|BG003|Baseline|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104144|NCT01607450|BG004|Baseline|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104145|NCT01607450|BG005|Baseline|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
11104146|NCT01607450|BG006|Baseline|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
11104147|NCT01607450|BG007|Baseline|Total|Total of all reporting groups
11104148|NCT01607450|FG000|Participant Flow|Lean Placebo|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
11104149|NCT01607450|FG001|Participant Flow|Lean GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104150|NCT01607450|FG002|Participant Flow|Type 2 DM GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104151|NCT01607450|FG003|Participant Flow|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104152|NCT01607450|FG004|Participant Flow|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104153|NCT01607450|FG005|Participant Flow|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
11104154|NCT01607450|FG006|Participant Flow|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104155|NCT01607450|OG000|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
11104156|NCT01607450|OG001|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104157|NCT01607450|OG002|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104158|NCT01607450|OG003|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104159|NCT01607450|OG004|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104160|NCT01607450|OG005|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
11104161|NCT01607450|OG006|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
11104162|NCT01607450|OG001|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104163|NCT01607450|OG002|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104164|NCT01607450|OG004|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104165|NCT01607450|OG005|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
11104166|NCT01607450|OG006|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
11104167|NCT01607450|EG000|Reported Event|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
11104168|NCT01607450|EG001|Reported Event|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104169|NCT01607450|EG002|Reported Event|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
11104170|NCT01607450|EG003|Reported Event|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11104171|NCT01607450|EG004|Reported Event|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
11007828|NCT01093183|FG000|Participant Flow|Phase I Treatment (Lenalidomide and Cyclophosphamide)|"Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~lenalidomide and cyclophosphamide: Given PO"
11007829|NCT01093183|FG001|Participant Flow|Phase II Treatment (Lenalidomide and Cyclophosphamide)|"Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~lenalidomide and cyclophosphamide: Given PO"
11007830|NCT01093183|OG000|Outcome|Treatment (Lenalidomide and Cyclophosphamide)|"Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~lenalidomide and cyclophosphamide: Given PO"
11007831|NCT01093183|EG000|Reported Event|Treatment (Lenalidomide and Cyclophosphamide)|"Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~lenalidomide and cyclophosphamide: Given PO"
11007832|NCT01093222|BG000|Baseline|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11007833|NCT01093222|FG000|Participant Flow|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11007834|NCT01093222|OG000|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11007835|NCT01093222|EG000|Reported Event|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11007836|NCT01093417|BG000|Baseline|Placebo|15 participants were randomized to matching placebo for 12 weeks
11007837|NCT01093417|BG001|Baseline|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
11007838|NCT01093417|BG002|Baseline|Total|Total of all reporting groups
11007839|NCT01093417|FG000|Participant Flow|Placebo|15 participants were randomized to matching placebo for 12 weeks
11007840|NCT01093417|FG001|Participant Flow|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
11007841|NCT01093417|OG000|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
11007842|NCT01093417|OG001|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
11007843|NCT01093417|EG000|Reported Event|Placebo|15 participants were randomized to matching placebo for 12 weeks
11007844|NCT01093417|EG001|Reported Event|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
11007845|NCT01093469|BG000|Baseline|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
11007846|NCT01093469|BG001|Baseline|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
11007847|NCT01093469|BG002|Baseline|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
11007848|NCT01093469|BG003|Baseline|Total|Total of all reporting groups
11007849|NCT01093469|FG000|Participant Flow|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
11007850|NCT01093469|FG001|Participant Flow|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
11007851|NCT01093469|FG002|Participant Flow|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
11007852|NCT01093469|OG000|Outcome|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
11007853|NCT01093469|OG001|Outcome|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
11007854|NCT01093469|OG002|Outcome|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
11007855|NCT01093469|EG000|Reported Event|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
11007856|NCT01093469|EG001|Reported Event|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
11007857|NCT01093469|EG002|Reported Event|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
11007858|NCT01093482|BG000|Baseline|Mechanically Ventilated Patients|"Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.~Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour."
11007859|NCT01093482|FG000|Participant Flow|Mechanically Ventilated Patients|"Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.~Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour."
11007860|NCT01093482|OG000|Outcome|Mechanically Ventilated Patients|"Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.~Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour."
11104172|NCT01607450|EG005|Reported Event|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
11104173|NCT01607450|EG006|Reported Event|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
11104174|NCT01607476|BG000|Baseline|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104175|NCT01607476|BG001|Baseline|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104176|NCT01607476|BG002|Baseline|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104177|NCT01607476|BG003|Baseline|Total|Total of all reporting groups
11104178|NCT01607476|FG000|Participant Flow|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104179|NCT01607476|FG001|Participant Flow|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104180|NCT01607476|FG002|Participant Flow|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104181|NCT01607476|OG000|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104182|NCT01607476|OG001|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104183|NCT01607476|OG002|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104184|NCT01607476|EG000|Reported Event|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104185|NCT01607476|EG001|Reported Event|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104186|NCT01607476|EG002|Reported Event|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
11104187|NCT01607554|BG000|Baseline|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
11104188|NCT01607554|FG000|Participant Flow|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
11104189|NCT01607554|OG000|Outcome|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
11104190|NCT01607554|EG000|Reported Event|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
11104191|NCT01607593|BG000|Baseline|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians.
11104192|NCT01607593|FG000|Participant Flow|SERTRALINE|Participants with post-traumatic stress disorder (PTSD) who were treated with sertraline as instructed by physicians
11104193|NCT01607593|OG000|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
11104194|NCT01607593|EG000|Reported Event|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians
11104195|NCT01607645|BG000|Baseline|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
11104196|NCT01607645|BG001|Baseline|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
11104197|NCT01607645|BG002|Baseline|Total|Total of all reporting groups
11104198|NCT01607645|FG000|Participant Flow|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
11104199|NCT01607645|FG001|Participant Flow|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
11104200|NCT01607645|OG000|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
11104201|NCT01607645|OG001|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
11104202|NCT01607645|EG000|Reported Event|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
11104203|NCT01607645|EG001|Reported Event|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
11104204|NCT01607658|BG000|Baseline|Placebo|"Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event~Placebo: placebo intranasal gel administered prn, 2-8 hours before a planned sexual event"
11104205|NCT01607658|BG001|Baseline|Low Dose TBS-2|"Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn~Low dose TBS-2: Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104206|NCT01607658|BG002|Baseline|Medium Dose TBS-2|"Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn~Medium dose TBS-2: Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104207|NCT01607658|BG003|Baseline|High Dose TBS-2|"High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn~High dose TBS-2: High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104208|NCT01607658|BG004|Baseline|Total|Total of all reporting groups
11104209|NCT01607658|FG000|Participant Flow|Placebo|"Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event~Placebo: placebo intranasal gel administered prn, 2-8 hours before a planned sexual event"
11104210|NCT01607658|FG001|Participant Flow|Low Dose TBS-2|"Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn~Low dose TBS-2: Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104211|NCT01607658|FG002|Participant Flow|Medium Dose TBS-2|"Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn~Medium dose TBS-2: Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104212|NCT01607658|FG003|Participant Flow|High Dose TBS-2|"High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn~High dose TBS-2: High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104213|NCT01607658|OG000|Outcome|Placebo|"Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event~Placebo: placebo intranasal gel administered prn, 2-8 hours before a planned sexual event"
11104214|NCT01607658|OG001|Outcome|Low Dose TBS-2|"Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn~Low dose TBS-2: Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104215|NCT01607658|OG002|Outcome|Medium Dose TBS-2|"Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn~Medium dose TBS-2: Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104216|NCT01607658|OG003|Outcome|High Dose TBS-2|"High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn~High dose TBS-2: High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104217|NCT01607658|EG000|Reported Event|Placebo|"Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event~Placebo: placebo intranasal gel administered prn, 2-8 hours before a planned sexual event"
11104218|NCT01607658|EG001|Reported Event|Low Dose TBS-2|"Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn~Low dose TBS-2: Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104219|NCT01607658|EG002|Reported Event|Medium Dose TBS-2|"Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn~Medium dose TBS-2: Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104220|NCT01607658|EG003|Reported Event|High Dose TBS-2|"High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn~High dose TBS-2: High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event"
11104221|NCT01607853|BG000|Baseline|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
11104222|NCT01607853|FG000|Participant Flow|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
11104223|NCT01607853|OG000|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
11104224|NCT01607853|OG001|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
11104225|NCT01607853|OG002|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
11104226|NCT01607853|OG003|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
11104227|NCT01607853|EG000|Reported Event|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
11104228|NCT01607892|BG000|Baseline|Diffuse Large B-cell Lymphoma (DLBCL)|Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
11104229|NCT01607892|BG001|Baseline|Non-Hodgkin Lymphoma (NHL) Excluding DLBCL|Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
11104230|NCT01607892|BG002|Baseline|Multiple Myeloma (MM)|Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
11104231|NCT01607892|BG003|Baseline|Acute Myeloid Leukemia (AML)|Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
11104232|NCT01607892|BG004|Baseline|Other Hematological Malignancies (ALL, CML and CLL)|Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
11104233|NCT01607892|BG005|Baseline|Total|Total of all reporting groups
11104234|NCT01607892|FG000|Participant Flow|Diffuse Large B-cell Lymphoma (DLBCL)|Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
11104235|NCT01607892|FG001|Participant Flow|Non-Hodgkin Lymphoma (NHL) Excluding DLBCL|Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
11104236|NCT01607892|FG002|Participant Flow|Multiple Myeloma (MM)|Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
11104237|NCT01607892|FG003|Participant Flow|Acute Myeloid Leukemia (AML)|Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
11104238|NCT01607892|FG004|Participant Flow|Other Hematological Malignancies (ALL, CML and CLL)|Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
11104239|NCT01607892|OG000|Outcome|Diffuse Large B-cell Lymphoma (DLBCL)|Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
11104240|NCT01607892|OG001|Outcome|Non-Hodgkin Lymphoma (NHL) Excluding DLBCL|Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
11126522|NCT01733745|EG001|Reported Event|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
11126523|NCT01733758|BG000|Baseline|Placebo|Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
11126524|NCT01733758|BG001|Baseline|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
11104241|NCT01607892|OG002|Outcome|Multiple Myeloma (MM)|Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
11104242|NCT01607892|OG003|Outcome|Acute Myeloid Leukemia (AML)|Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
11104243|NCT01607892|OG004|Outcome|Other Hematological Malignancies (ALL, CML and CLL)|Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
11104244|NCT01607892|OG000|Outcome|Advanced Hematological Malignancies.|Participants received selinexor doses of <= 12 mg/m^2, post oral for all cycles 3 times weekly for Weeks 1 and 3 in schedule 1; >12 mg/m^2 3 times weekly for Weeks 2 and 4 in schedule 2; >=30 mg/m^2 on Day 1 and 3 in schedule 3; >= 23 mg/m^2 on Day 1 and Day 2 for a 28-day cycle in schedule 4; >= 30 mg/m^2 on Day 1 and 4 in schedule 5; >= 35 mg/m^2 combined with dexamethasone 20 mg on Day 1 and 3 in schedule 6; >= 45 mg/m^2 once-weekly in schedule 7; >= 40 mg/m^2 twice-weekly for first 2 weeks on Days 1, 3, 8, and 10 followed by an 11-day treatment-free interval in schedule 8; >= 30 mg/m^2 twice weekly for 3 weeks in 28-day cycle followed by fixed dose of 375 mg/m^2 Rituximab in schedule 9; 55 mg/m^2 twice-weekly on Days 1, 3, 8, and 10 followed by 18-day treatment-free interval in schedule 10; 40, 60, 80 mg (group A, group B, group C) twice weekly during the first 3 weeks, on Days 1, 3, 8, 10, 15 and 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
11104245|NCT01607892|OG000|Outcome|Selinexor (3 mg/m^2)|Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
11104246|NCT01607892|OG001|Outcome|Selinexor (6 mg/m^2)|Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
11104247|NCT01607892|OG002|Outcome|Selinexor (12 mg/m^2)|Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
11104248|NCT01607892|OG003|Outcome|Selinexor (16.8 mg/m^2)|Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
11104249|NCT01607892|OG004|Outcome|Selinexor (23 mg/m^2)|Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
11104250|NCT01607892|OG005|Outcome|Selinexor (30 mg/m^2)|Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
11104251|NCT01607892|OG006|Outcome|Selinexor (35 mg/m^2)|Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
11104252|NCT01607892|OG007|Outcome|Selinexor (40 mg/m^2)|Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
11104253|NCT01607892|OG008|Outcome|Selinexor (46 mg/m^2)|Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
11104254|NCT01607892|OG009|Outcome|Selinexor (55 mg/m^2)|Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
11104255|NCT01607892|OG010|Outcome|Selinexor (60 mg/m^2)|Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
11104256|NCT01607892|OG011|Outcome|Selinexor (70 mg/m^2)|Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
11104257|NCT01607892|OG012|Outcome|Selinexor (80 mg/m^2)|Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
11126525|NCT01733758|BG002|Baseline|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
11126526|NCT01733758|BG003|Baseline|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
11126527|NCT01733758|BG004|Baseline|Total|Total of all reporting groups
11104258|NCT01607892|EG000|Reported Event|Diffuse Large B-cell Lymphoma (DLBCL)|Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
11104259|NCT01607892|EG001|Reported Event|Non-Hodgkin Lymphoma (NHL) Excluding DLBCL|Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
11104260|NCT01607892|EG002|Reported Event|Multiple Myeloma (MM)|Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
11104261|NCT01607892|EG003|Reported Event|Acute Myeloid Leukemia (AML)|Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
11104262|NCT01607892|EG004|Reported Event|Other Hematological Malignancies (ALL, CML and CLL)|Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
11104263|NCT01607905|BG000|Baseline|Arm A (Colorectal Cancer)|Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 milligrams per meter square (mg/m^2) 3 times weekly (TIW) during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m^2 once weekly (QW) up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104264|NCT01607905|BG001|Baseline|Arm B (Gynecological Cancer)|Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11126528|NCT01733758|FG000|Participant Flow|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52.
11126529|NCT01733758|FG001|Participant Flow|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
10846748|NCT00279708|FG000|Participant Flow|Intervention Group (Atorvastatin)|Atorvastatin Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
11104265|NCT01607905|BG002|Baseline|Arm C (Squamous Cell Cancer)|Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104266|NCT01607905|BG003|Baseline|Arm D (Castrate-resistant Prostate Cancer)|Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104267|NCT01607905|BG004|Baseline|Arm E (Glioblastoma Multiforme)|Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104268|NCT01607905|BG005|Baseline|Arm F (Melanoma)|Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104269|NCT01607905|BG006|Baseline|Arm G (Other Solid Tumors)|Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104270|NCT01607905|BG007|Baseline|Total|Total of all reporting groups
11104271|NCT01607905|FG000|Participant Flow|Arm A (Colorectal Cancer)|Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 milligrams per meter square (mg/m^2) 3 times weekly (TIW) during Weeks 1 and 3, twice weekly (BIW) during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m^2 once weekly (QW) up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104272|NCT01607905|FG001|Participant Flow|Arm B (Gynecological Cancer)|Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104273|NCT01607905|FG002|Participant Flow|Arm C (Squamous Cell Cancer)|Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11126530|NCT01733758|FG002|Participant Flow|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
11126531|NCT01733758|FG003|Participant Flow|Open Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
11104274|NCT01607905|FG003|Participant Flow|Arm D (Castrate-resistant Prostate Cancer)|Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104275|NCT01607905|FG004|Participant Flow|Arm E (Glioblastoma Multiforme)|Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104276|NCT01607905|FG005|Participant Flow|Arm F (Melanoma)|Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104277|NCT01607905|FG006|Participant Flow|Arm G (Other Solid Tumors)|Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104278|NCT01607905|OG000|Outcome|Arm A (Colorectal Cancer)|Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104279|NCT01607905|OG001|Outcome|Arm B (Gynecological Cancer)|Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104280|NCT01607905|OG002|Outcome|Arm C (Squamous Cell Cancer)|Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104281|NCT01607905|OG003|Outcome|Arm D (Castrate-resistant Prostate Cancer)|Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104282|NCT01607905|OG004|Outcome|Arm E (Glioblastoma Multiforme)|Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11004238|NCT01076049|BG001|Baseline|Irrisept Device System|"For subjects randomized to the investigational group, Irrisept was used.~Irrisept Delivery System: Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression.~Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits."
11004239|NCT01076049|BG002|Baseline|Randomization Unknown|
11004240|NCT01076049|BG003|Baseline|Total|Total of all reporting groups
11004241|NCT01076049|FG000|Participant Flow|Standard of Care (SoC)|The type of irrigation solution and method used as SoC was determined by the participating emergency department physician. The SoC method was used at the initial and 48-hour follow-up visit.
11004242|NCT01076049|FG001|Participant Flow|Irrisept Delivery System|"Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.~Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression."
11004243|NCT01076049|FG002|Participant Flow|Randomization Unknown|The randomization group (SoC or Irrisept) is unknown for 1 subject.
11004244|NCT01076049|OG000|Outcome|Standard of Care (SoC)|"For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).~Standard of Care (SoC): The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits."
11004245|NCT01076049|OG001|Outcome|Irrisept Device System|"For subjects randomized to the investigational group, Irrisept was used.~Irrisept Delivery System: Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression.~Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits."
11004246|NCT01076049|OG002|Outcome|Randomization Unknown|
11004247|NCT01076049|OG000|Outcome|Standard of Care (SoC)|The type of irrigation solution and method used as SoC was determined by the participating emergency department physician. The SoC method was used at the initial and 48-hour follow-up visit.
11004248|NCT01076049|OG001|Outcome|Irrisept Delivery System|"Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.~Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression."
11004249|NCT01076049|EG000|Reported Event|Standard of Care (SoC)|The type of irrigation solution and method used as SoC was determined by the participating emergency department physician. The SoC method was used at the initial and 48-hour follow-up visit.
11004250|NCT01076049|EG001|Reported Event|Irrisept Delivery System|"Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.~Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression."
11004251|NCT01076049|EG002|Reported Event|Randomization Unknown|There are records of an additional subject completing the study, but no randomization information was available.
11004252|NCT01076075|BG000|Baseline|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
11004253|NCT01076075|BG001|Baseline|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
11004254|NCT01076075|BG002|Baseline|Total|Total of all reporting groups
11004255|NCT01076075|FG000|Participant Flow|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
11004256|NCT01076075|FG001|Participant Flow|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
11004257|NCT01076075|OG000|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg
11004258|NCT01076075|OG001|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
11004259|NCT01076075|OG000|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
11004260|NCT01076075|OG000|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
11004261|NCT01076075|OG001|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
11004262|NCT01076075|EG000|Reported Event|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
11004263|NCT01076075|EG001|Reported Event|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
11004264|NCT01076088|BG000|Baseline|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
11004265|NCT01076088|BG001|Baseline|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
11004266|NCT01076088|BG002|Baseline|Metformin 500 mg|Metformin 500 mg twice daily
11004267|NCT01076088|BG003|Baseline|Metformin 850|Metformin 850 mg twice daily
11004268|NCT01076088|BG004|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
11104283|NCT01607905|OG005|Outcome|Arm F (Melanoma)|Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104284|NCT01607905|OG006|Outcome|Arm G (Other Solid Tumors)|Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104285|NCT01607905|OG000|Outcome|Arms A to G: Overall Solid Tumor Malignancies|Participants with colorectal cancer with liver metastasis, gynecological cancer, squamous cell cancer, CRPC, GBM, melanoma, other solid tumors received oral selinexor as a single agent in eight schedules, schedule 1. ≤12 mg/m^2 TIW in Weeks 1 and 3, BIW in Weeks 2 and 4, schedule 2. >12 mg/m^2 TIW in Weeks 1 and 3, BIW in Weeks 2 and 4, schedule 3. ≥ 30 mg/m^2 BIW (Days 1 and 3), schedule 4. ≥20 mg/m^2 BIW (Days 1 and 2), schedule 5. ≥35 mg/m^2 BIW (Days 1 and 4), schedule 6. ≥20 mg/m^2 BIW (Days 1 and 4), schedule 7. ≥50 mg/m^2 once weekly (QW), schedule 8. ≥45 mg/m^2 BIW (Days 1 and 3) until disease progression, death, or unacceptable toxicity.
11104286|NCT01607905|OG000|Outcome|Selinexor Dose: 3 mg/m^2|Participants received 3 milligram per square meter (mg/m^2) of selinexor for Cycle1 Day1.
11104287|NCT01607905|OG001|Outcome|Selinexor Dose: 6 mg/m^2|Participants received single oral dose of 6 mg/m^2 Selinexor for Cycle1 Day1.
11104288|NCT01607905|OG002|Outcome|Selinexor Dose: 12 mg/m^2|Participants received single oral dose of 12 mg/m^2 Selinexor for Cycle1 Day1.
11104289|NCT01607905|OG003|Outcome|Selinexor Dose: 16.8 mg/m^2|Participants received single oral dose of 16.8 mg/m^2 Selinexor for Cycle1 Day1.
11104290|NCT01607905|OG004|Outcome|Selinexor Dose: 20 mg/m^2|Participants received single oral dose of 20 mg/m^2 Selinexor for Cycle1 Day1.
11104291|NCT01607905|OG005|Outcome|Selinexor Dose: 23 mg/m^2|Participants received single oral dose of 23 mg/m^2 Selinexor for Cycle1Day1.
11104292|NCT01607905|OG006|Outcome|Selinexor Dose: 28 mg/m^2|Participants received single oral dose of 28 mg/m^2 Selinexor for Cycle1 Day1.
11104293|NCT01607905|OG007|Outcome|Selinexor Dose: 30 mg/m^2|Participants received single oral dose of 30 mg/m^2 Selinexor for Cycle1 Day1.
11104294|NCT01607905|OG008|Outcome|Selinexor Dose: 35 mg/m^2|Participants received single oral dose of 35 mg/m^2 Selinexor for Cycle1 Day1.
11104295|NCT01607905|OG009|Outcome|Selinexor Dose: 39 mg/m^2|Participants received single oral dose of 39 mg/m^2 Selinexor for Cycle1 Day1.
11104296|NCT01607905|OG010|Outcome|Selinexor Dose: 40 mg/m^2|Participants received single oral dose of 40 mg/m^2 Selinexor for Cycle1 Day1.
11104297|NCT01607905|OG011|Outcome|Selinexor Dose: 45 mg/m^2|Participants received single oral dose of 45 mg/m^2 Selinexor for Cycle1 Day1.
11104298|NCT01607905|OG012|Outcome|Selinexor Dose: 50 mg/m^2|Participants received single oral dose of 50 mg/m^2 Selinexor for Cycle1 Day1.
11104299|NCT01607905|OG013|Outcome|Selinexor Dose: 55 mg/m^2|Participants received single oral dose of 55 mg/m^2 Selinexor for Cycle1 Day1.
11104300|NCT01607905|OG014|Outcome|Selinexor Dose: 58 mg/m^2|Participants received single oral dose of 58 mg/m^2 Selinexor for Cycle1 Day1.
11104301|NCT01607905|OG015|Outcome|Selinexor Dose: 65 mg/m^2|Participants received single oral dose of 65 mg/m^2 Selinexor for Cycle1 Day1.
11104302|NCT01607905|OG016|Outcome|Selinexor Dose: 70 mg/m^2|Participants received single oral dose of 70 mg/m^2 Selinexor for Cycle1 Day1.
11104303|NCT01607905|OG017|Outcome|Selinexor Dose: 80 mg/m^2|Participants received single oral dose of 80 mg/m^2 Selinexor for Cycle1 Day1.
11104304|NCT01607905|OG018|Outcome|Selinexor Dose: 85 mg/m^2|Participants received single oral dose of 85 mg/m^2 Selinexor for Cycle1 Day1.
11104305|NCT01607905|OG000|Outcome|Selinexor Dose: 3 mg/m^2|Participants received 3 mg/m^2 of selinexor for Cycle1 Day1.
11104306|NCT01607905|OG005|Outcome|Selinexor Dose: 23 mg/m^2|Participants received single oral dose of 23 mg/m^2 Selinexor for Cycle1 Day1.
11104307|NCT01607905|OG007|Outcome|Selinexor Dose: 30 mg/m^2|Participants received single oral dose of 30 mg/m^2 Selinexor for Cycle1Day1.
11104308|NCT01607905|OG000|Outcome|Selinexor Dose: 3 Milligram Per Square Meter (mg/m2)|Participants received 3 mg/m2 of selinexor for Cycle1Day1.
11104309|NCT01607905|OG001|Outcome|Selinexor Dose: 6 mg/m2|Participants received single oral dose of 6 mg/m2 Selinexor for Cycle1Day1.
11104310|NCT01607905|OG002|Outcome|Selinexor Dose: 12 mg/m2|Participants received single oral dose of 12 mg/m2 Selinexor for Cycle1Day1.
11104311|NCT01607905|OG003|Outcome|Selinexor Dose: 16.8 mg/m2|Participants received single oral dose of 16.8 mg/m2 Selinexor for Cycle1Day1.
11104312|NCT01607905|OG004|Outcome|Selinexor Dose: 20 mg/m2|Participants received single oral dose of 20 mg/m2 Selinexor for Cycle1Day1.
11104313|NCT01607905|OG005|Outcome|Selinexor Dose: 23 mg/m2|Participants received single oral dose of 23 mg/m2 Selinexor for Cycle1Day1.
11104314|NCT01607905|OG006|Outcome|Selinexor Dose: 28 mg/m2|Participants received single oral dose of 28 mg/m2 Selinexor for Cycle1Day1.
11104315|NCT01607905|OG007|Outcome|Selinexor Dose: 30 mg/m2|Participants received single oral dose of 30 mg/m2 Selinexor for Cycle1Day1.
11104316|NCT01607905|OG008|Outcome|Selinexor Dose: 35 mg/m2|Participants received single oral dose of 35 mg/m2 Selinexor for Cycle1Day1.
11104317|NCT01607905|OG009|Outcome|Selinexor Dose: 39 mg/m2|Participants received single oral dose of 39 mg/m2 Selinexor for Cycle1Day1.
11104318|NCT01607905|OG010|Outcome|Selinexor Dose: 40 mg/m2|Participants received single oral dose of 40 mg/m2 Selinexor for Cycle1Day1.
11104319|NCT01607905|OG011|Outcome|Selinexor Dose: 45 mg/m2|Participants received single oral dose of 45 mg/m2 Selinexor for Cycle1Day1.
11104320|NCT01607905|OG012|Outcome|Selinexor Dose: 50 mg/m2|Participants received single oral dose of 50 mg/m2 Selinexor for Cycle1Day1.
11104321|NCT01607905|OG013|Outcome|Selinexor Dose: 55 mg/m2|Participants received single oral dose of 55 mg/m2 Selinexor for Cycle1Day1.
11104322|NCT01607905|OG014|Outcome|Selinexor Dose: 58 mg/m2|Participants received single oral dose of 58 mg/m2 Selinexor for Cycle1Day1.
11104323|NCT01607905|OG015|Outcome|Selinexor Dose: 65 mg/m2|Participants received single oral dose of 65 mg/m2 Selinexor for Cycle1Day1.
11104324|NCT01607905|OG016|Outcome|Selinexor Dose: 70 mg/m2|Participants received single oral dose of 70 mg/m2 Selinexor for Cycle1Day1.
11104325|NCT01607905|OG017|Outcome|Selinexor Dose: 80 mg/m2|Participants received single oral dose of 80 mg/m2 Selinexor for Cycle1Day1.
11104326|NCT01607905|OG018|Outcome|Selinexor Dose: 85 mg/m2|Participants received single oral dose of 85 mg/m2 Selinexor for Cycle1Day1.
11104327|NCT01607905|EG000|Reported Event|Arm A (Colorectal Cancer)|Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104328|NCT01607905|EG001|Reported Event|Arm B (Gynecological Cancer)|Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104329|NCT01607905|EG002|Reported Event|Arm C (Squamous Cell Cancer)|Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104330|NCT01607905|EG003|Reported Event|Arm D (Castrate-resistant Prostate Cancer)|Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104331|NCT01607905|EG004|Reported Event|Arm E (Glioblastoma Multiforme)|Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104332|NCT01607905|EG005|Reported Event|Arm F (Melanoma)|Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11104333|NCT01607905|EG006|Reported Event|Arm G (Other Solid Tumors)|Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
11126532|NCT01733758|OG000|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
11126533|NCT01733758|OG001|Outcome|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
11104334|NCT01607957|BG000|Baseline|TAS-102|Participants received TAS-102 orally with a starting dose of 35 mg/m^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
11104335|NCT01607957|BG001|Baseline|Placebo|Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
11104336|NCT01607957|BG002|Baseline|Total|Total of all reporting groups
11104337|NCT01607957|FG000|Participant Flow|TAS-102|Participants received TAS-102 orally with a starting dose of 35 milligram per meter square per dose (mg/m^2/dose) twice daily (BID) based on body surface area (BSA) along with best supportive care (BSC). The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7. The treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
11104338|NCT01607957|FG001|Participant Flow|Placebo|Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7. The treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
11104339|NCT01607957|OG000|Outcome|TAS-102|Participants received TAS-102 orally with a starting dose of 35 mg/m^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
11104340|NCT01607957|OG001|Outcome|Placebo|Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
11104341|NCT01607957|EG000|Reported Event|TAS-102|Participants received TAS-102 orally with a starting dose of 35 mg/m^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
11104342|NCT01607957|EG001|Reported Event|Placebo|Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
11104343|NCT01608061|BG000|Baseline|DBS-f on|"DBS-f on~DBS-f on: deep brain stimulation of the fornix"
11104344|NCT01608061|BG001|Baseline|DBS-f Off|"DBS-f off~DBS-f off: deep brain stimulation of the fornix turned off"
11104345|NCT01608061|BG002|Baseline|Total|Total of all reporting groups
11104346|NCT01608061|FG000|Participant Flow|DBS-f on|"DBS-f on~DBS-f on: deep brain stimulation of the fornix"
11104347|NCT01608061|FG001|Participant Flow|DBS-f Off|"DBS-f off~DBS-f off: deep brain stimulation of the fornix turned off"
11104348|NCT01608061|OG000|Outcome|All Implanted Subject|All implanted subjects are included in this group.
11104349|NCT01608061|OG000|Outcome|DBS-f on|"DBS-f on~DBS-f on: deep brain stimulation of the fornix"
11104350|NCT01608061|OG001|Outcome|DBS-f Off|"DBS-f off~DBS-f off: deep brain stimulation of the fornix turned off"
11104351|NCT01608061|EG000|Reported Event|DBS-f on|"DBS-f on~DBS-f on: deep brain stimulation of the fornix"
11104352|NCT01608061|EG001|Reported Event|DBS-f Off|"DBS-f off~DBS-f off: deep brain stimulation of the fornix turned off"
11104353|NCT01608087|BG000|Baseline|BI 695502 (T)|Subjects were administered a single dose of 25 milligram per millilitre (mg/mL) BI 695502 concentrate for solution for infusion.
11104354|NCT01608087|BG001|Baseline|United States (US)-Licensed Avastin® (R1)|Subjects were administered a single dose of 25 milligram per millilitre (mg/mL) US-licensed Avastin® solution for intravenous infusion.
11104355|NCT01608087|BG002|Baseline|European Union (EU)-Approved Avastin® (R2)|Subjects were administered a single dose of 25 microgram per millilitre (mg/mL) EU-approved Avastin® concentrate for solution for infusion.
11104356|NCT01608087|BG003|Baseline|Total|Total of all reporting groups
11104357|NCT01608087|FG000|Participant Flow|BI 695502 (T)|Subjects were administered a single dose of 25 milligram per millilitre (mg/mL) BI 695502 concentrate for solution for infusion.
11104358|NCT01608087|FG001|Participant Flow|United States (US)-Licensed Avastin® (R1)|Subjects were administered a single dose of 25 milligram per millilitre (mg/mL) US-licensed Avastin® solution for intravenous infusion.
11104359|NCT01608087|FG002|Participant Flow|European Union (EU)-Approved Avastin® (R2)|Subjects were administered a single dose of 25 microgram per millilitre (mg/mL) EU-approved Avastin® concentrate for solution for infusion.
11104360|NCT01608087|OG000|Outcome|BI 695502 (T)|Subjects were administered a single dose of 25 milligram per millilitre (mg/mL) BI 695502 concentrate for solution for infusion.
11104361|NCT01608087|OG001|Outcome|United States (US)-Licensed Avastin® (R1)|Subjects were administered a single dose of 25 milligram per millilitre (mg/mL) US-licensed Avastin® solution for intravenous infusion.
11104362|NCT01608087|OG002|Outcome|European Union (EU)-Approved Avastin® (R2)|Subjects were administered a single dose of 25 microgram per millilitre (mg/mL) EU-approved Avastin® concentrate for solution for infusion.
11104363|NCT01608087|EG000|Reported Event|BI 695502 (T)|Subjects were administered a single dose of 25 milligram per millilitre (mg/mL) BI 695502 concentrate for solution for infusion.
11104364|NCT01608087|EG001|Reported Event|United States (US)-Licensed Avastin® (R1)|Subjects were administered a single dose of 25 milligram per millilitre (mg/mL) US-licensed Avastin® solution for intravenous infusion.
11104365|NCT01608087|EG002|Reported Event|European Union (EU)-Approved Avastin® (R2)|Subjects were administered a single dose of 25 microgram per millilitre(mg/mL) EU-approved Avastin® concentrate for solution for infusion.
11104366|NCT01608100|BG000|Baseline|ARCHITECT STAT High Sensitive Troponin I Assay Testing|All subjects will have their blood tested by the investigational ARCHITECT STAT High Sensitive Troponin I assay. Specimens were collected at 11 emergency departments from 1,101 subjects presenting to the emergency department with symptoms consistent with acute coronary syndrome (ACS). All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care.
11104367|NCT01608100|FG000|Participant Flow|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.~ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.~Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
11104368|NCT01608100|OG000|Outcome|Area Under the Curve in K2 EDTA|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
11104369|NCT01608100|OG001|Outcome|Area Under the Curve in Lithium Heparin Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
11104370|NCT01608100|OG002|Outcome|Area Under the Curve in Serum Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
11104371|NCT01608100|OG000|Outcome|30-day Prognosis for K2 EDTA Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
11104372|NCT01608100|OG001|Outcome|90-day Prognosis for K2 EDTA Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
11104373|NCT01608100|OG002|Outcome|30-day Prognosis for Lithium Heparin Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
11104374|NCT01608100|OG003|Outcome|90-day Prognosis for Lithium Heparin Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
11104375|NCT01608100|OG004|Outcome|30-day Prognosis for Serum Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
11104376|NCT01608100|OG005|Outcome|90-day Prognosis for Serum Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
11104377|NCT01608100|OG000|Outcome|Sensitivity in K2 EDTA|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
11104378|NCT01608100|OG001|Outcome|Sensitivity in Lithium Heparin Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
11104379|NCT01608100|OG002|Outcome|Sensitivity in Serum Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
11104380|NCT01608100|OG000|Outcome|Specificity in K2 EDTA|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
11104381|NCT01608100|OG001|Outcome|Specificity in Lithium Heparin Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
11104382|NCT01608100|OG002|Outcome|Specificity in Serum Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
11104383|NCT01608100|OG000|Outcome|Negative Predictive Value in K2 EDTA|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
11104384|NCT01608100|OG001|Outcome|Negative Predictive Value in Lithium Heparin Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
11104385|NCT01608100|OG002|Outcome|Negative Predictive Value in Serum Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
11104386|NCT01608100|OG000|Outcome|Positive Predictive Value in K2 EDTA|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
11104387|NCT01608100|OG001|Outcome|Positive Predictive Value in Lithium Heparin Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
11104388|NCT01608100|OG002|Outcome|Positive Predictive Value in Serum Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
11104389|NCT01608100|EG000|Reported Event|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.~ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.~Results obtained will be used to assess the prognosis of subjects with a troponin result for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
11104390|NCT01608295|BG000|Baseline|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
11104391|NCT01608295|BG001|Baseline|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
11104392|NCT01608295|BG002|Baseline|Total|Total of all reporting groups
11104393|NCT01608295|FG000|Participant Flow|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
11104394|NCT01608295|FG001|Participant Flow|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
11104395|NCT01608295|OG000|Outcome|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
11104396|NCT01608295|OG001|Outcome|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
11104397|NCT01608295|OG000|Outcome|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
11126534|NCT01733758|OG002|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
11126535|NCT01733758|OG003|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
11126536|NCT01733758|OG001|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
11104398|NCT01608295|OG001|Outcome|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
11104399|NCT01608295|OG000|Outcome|Vilazodone and Paroxetine|Subjects randomized to receive vilazodone relative to subjects randomized to receive paroxetine.
11104400|NCT01608295|EG000|Reported Event|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
11104401|NCT01608295|EG001|Reported Event|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
11104402|NCT01608308|BG000|Baseline|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
11104403|NCT01608308|BG001|Baseline|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
11104404|NCT01608308|BG002|Baseline|Total|Total of all reporting groups
11104405|NCT01608308|FG000|Participant Flow|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
11104406|NCT01608308|FG001|Participant Flow|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
11104407|NCT01608308|OG000|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
11104408|NCT01608308|OG001|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
11104409|NCT01608308|EG000|Reported Event|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
11104410|NCT01608308|EG001|Reported Event|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
11104411|NCT01608321|BG000|Baseline|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11104412|NCT01608321|BG001|Baseline|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
11104413|NCT01608321|BG002|Baseline|Total|Total of all reporting groups
11104414|NCT01608321|FG000|Participant Flow|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11126537|NCT01733758|EG000|Reported Event|Placebo - Before Switch|(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24.
11104415|NCT01608321|FG001|Participant Flow|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
11104416|NCT01608321|OG000|Outcome|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11104417|NCT01608321|OG001|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
11104418|NCT01608321|EG000|Reported Event|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11104419|NCT01608321|EG001|Reported Event|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
11104420|NCT01608490|BG000|Baseline|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
11104421|NCT01608490|BG001|Baseline|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
11104422|NCT01608490|BG002|Baseline|Total|Total of all reporting groups
11104423|NCT01608490|FG000|Participant Flow|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
11104424|NCT01608490|FG001|Participant Flow|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
11104425|NCT01608490|OG000|Outcome|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
11104426|NCT01608490|OG001|Outcome|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
11104427|NCT01608490|EG000|Reported Event|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
11104428|NCT01608490|EG001|Reported Event|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
11104429|NCT01608659|BG000|Baseline|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
11104430|NCT01608659|FG000|Participant Flow|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
11104431|NCT01608659|OG000|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
11104432|NCT01608659|EG000|Reported Event|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
11104433|NCT01608672|BG000|Baseline|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
11104434|NCT01608672|FG000|Participant Flow|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
11104435|NCT01608672|OG000|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
11104436|NCT01608672|EG000|Reported Event|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
11104437|NCT01608724|BG000|Baseline|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
11104438|NCT01608724|FG000|Participant Flow|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
11104439|NCT01608724|OG000|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
11104440|NCT01608724|EG000|Reported Event|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
11104441|NCT01608815|BG000|Baseline|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104442|NCT01608815|BG001|Baseline|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104443|NCT01608815|BG002|Baseline|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104444|NCT01608815|BG003|Baseline|Total|Total of all reporting groups
11104445|NCT01608815|FG000|Participant Flow|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104446|NCT01608815|FG001|Participant Flow|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104447|NCT01608815|FG002|Participant Flow|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104448|NCT01608815|OG000|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104449|NCT01608815|OG001|Outcome|Dolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104450|NCT01608815|OG002|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104451|NCT01608815|OG001|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
11104452|NCT01608815|EG000|Reported Event|Adults (Group 1)|Participants ≥18 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
11104453|NCT01608815|EG001|Reported Event|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
11104454|NCT01608815|EG002|Reported Event|Children (Group 3)|Participants 2 to 11 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
11104455|NCT01608971|BG000|Baseline|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
11104456|NCT01608971|BG001|Baseline|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
11104457|NCT01608971|BG002|Baseline|Total|Total of all reporting groups
11104458|NCT01608971|FG000|Participant Flow|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
11104459|NCT01608971|FG001|Participant Flow|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
11104460|NCT01608971|OG000|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
11104461|NCT01608971|OG001|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
11104462|NCT01608971|OG000|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
11104463|NCT01608971|OG001|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
11104464|NCT01608971|EG000|Reported Event|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
11104465|NCT01608971|EG001|Reported Event|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
11104466|NCT01609010|BG000|Baseline|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
11104467|NCT01609010|BG001|Baseline|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
11104468|NCT01609010|BG002|Baseline|Total|Total of all reporting groups
11104469|NCT01609010|FG000|Participant Flow|Rituximab Monotherapy|Participants rituximab received 375 milligrams per square meter (mg/m^2), intravenously (IV), once weekly for 4 weeks. Participants who achieved minor response (MR), partial response (PR), or complete response (CR) after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
11104470|NCT01609010|FG001|Participant Flow|Rituximab + Interferon (IFN)|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-alpha2a (IFN-α2a), 3 million international units per day (MIU/day), subcutaneously (SC), during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
11104471|NCT01609010|OG000|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
11104472|NCT01609010|OG001|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
11104473|NCT01609010|EG000|Reported Event|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
11104474|NCT01609010|EG001|Reported Event|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
11104475|NCT01609023|BG000|Baseline|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
11104476|NCT01609023|FG000|Participant Flow|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
11104477|NCT01609023|OG000|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
11104478|NCT01609023|EG000|Reported Event|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
11104479|NCT01609062|BG000|Baseline|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
11104480|NCT01609062|BG001|Baseline|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
11104481|NCT01609062|BG002|Baseline|Total|Total of all reporting groups
11104482|NCT01609062|FG000|Participant Flow|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
11104483|NCT01609062|FG001|Participant Flow|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
11104484|NCT01609062|OG000|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
11104485|NCT01609062|OG001|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
11104486|NCT01609062|OG002|Outcome|All Subjects|Both groups combined
11104487|NCT01609062|EG000|Reported Event|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
11104488|NCT01609062|EG001|Reported Event|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
11126538|NCT01733758|EG001|Reported Event|Placebo - After Switch|(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
11126539|NCT01733758|EG002|Reported Event|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
11126540|NCT01733758|EG003|Reported Event|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
11126541|NCT01733758|EG004|Reported Event|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
11126542|NCT01733953|BG000|Baseline|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
11126543|NCT01733953|BG001|Baseline|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
11126544|NCT01733953|BG002|Baseline|Total|Total of all reporting groups
11126545|NCT01733953|FG000|Participant Flow|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
11126546|NCT01733953|FG001|Participant Flow|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
11126547|NCT01733953|OG000|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
11126548|NCT01733953|OG001|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
11126549|NCT01733953|EG000|Reported Event|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
11126550|NCT01733953|EG001|Reported Event|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
11126551|NCT01734161|BG000|Baseline|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
11126552|NCT01734161|BG001|Baseline|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
11126553|NCT01734161|BG002|Baseline|Total|Total of all reporting groups
11126554|NCT01734161|FG000|Participant Flow|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
11126555|NCT01734161|FG001|Participant Flow|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
11126556|NCT01734161|OG000|Outcome|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
11126557|NCT01734161|OG001|Outcome|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
11126558|NCT01734161|EG000|Reported Event|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
11104489|NCT01609218|BG000|Baseline|All Participants|This was 2-period crossover study. Participants received single oral doses of LY2140023 on 2 different occasions: 1) 80 mg LY2140023 administered alone (Treatment A) and 2) 80 mg LY2140023 administered and followed 1 hour later by a single oral dose of 75 g aqueous activated charcoal (Treatment B). Participants were randomly assigned to treatment sequence AB or BA.
11004269|NCT01076088|BG005|Baseline|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
11004270|NCT01076088|BG006|Baseline|Total|Total of all reporting groups
11004271|NCT01076088|FG000|Participant Flow|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
11004272|NCT01076088|FG001|Participant Flow|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
11004273|NCT01076088|FG002|Participant Flow|Metformin 500 mg|Metformin 500 mg twice daily
11004274|NCT01076088|FG003|Participant Flow|Metformin 850|Metformin 850 mg twice daily
11004275|NCT01076088|FG004|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
11004276|NCT01076088|FG005|Participant Flow|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
11004277|NCT01076088|OG000|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
11004278|NCT01076088|OG001|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
11004279|NCT01076088|OG002|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
11004280|NCT01076088|OG003|Outcome|Metformin 850 mg|Metformin 850 mg twice daily
11004281|NCT01076088|OG004|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
11004282|NCT01076088|OG005|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
11004283|NCT01076088|OG003|Outcome|Metformin 850|Metformin 850 mg twice daily
11004284|NCT01076088|EG000|Reported Event|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
11004285|NCT01076088|EG001|Reported Event|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
11004286|NCT01076088|EG002|Reported Event|Metformin 500 mg|Metformin 500 mg twice daily
11004287|NCT01076088|EG003|Reported Event|Metformin 850|Metformin 850 mg twice daily
11004288|NCT01076088|EG004|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
11004289|NCT01076088|EG005|Reported Event|Placebo|Matching placebo to sitagliptin and/or metformin. Population excludes 1 participant who did not receive any study medication.
11004290|NCT01076153|BG000|Baseline|Klacid MR|The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.
11004291|NCT01076153|FG000|Participant Flow|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
11004292|NCT01076153|OG000|Outcome|Klacid MR (Total Number Recovered)|Male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR who were in the recovered population.
11004293|NCT01076153|OG001|Outcome|Klacid MR (URTI, Recovered)|Participants in the recovered population who had a diagnosis of upper respiratory tract infection (URTI) at study entry.
11004294|NCT01076153|OG002|Outcome|Klacid MR (LRTI, Recovered)|Participants in the recovered population who had a diagnosis of lower respiratory tract infection (LRTI) at study entry.
11004295|NCT01076153|OG003|Outcome|Klacid MR (URTI and LRTI, Recovered)|Participants in the recovered population who had a diagnosis of both upper and lower respiratory tract infections at study entry.
11004296|NCT01076153|OG000|Outcome|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
11004297|NCT01076153|EG000|Reported Event|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
11004298|NCT01076166|BG000|Baseline|Klacid Granules (Total)|The per-protocol population (308 participants) of male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
11004299|NCT01076166|FG000|Participant Flow|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
11004300|NCT01076166|OG000|Outcome|Klacid Granules (Total Number Recovered)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information who were in the recovered population.
11004301|NCT01076166|OG001|Outcome|Klacid Granules (Bronchitis, Recovered)|Participants in the recovered population who had a diagnosis of bronchitis at study entry.
11004302|NCT01076166|OG002|Outcome|Klacid Granules (Pneumonia, Recovered)|Participants in the recovered population who had a diagnosis of pneumonia at study entry.
11004303|NCT01076166|OG000|Outcome|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
11004304|NCT01076166|EG000|Reported Event|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
11004305|NCT01076179|BG000|Baseline|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
11004306|NCT01076179|FG000|Participant Flow|HIV-infected Participants|Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists
11004307|NCT01076179|OG000|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
11104490|NCT01609218|FG000|Participant Flow|First LY2140023 Alone, Then LY2140023 + Activated Charcoal|"Period 1: Single oral dose of 80 milligrams (mg) LY2140023 administered alone~Period 2: Single oral dose of 80 mg LY2140023 followed 1 hour later by single oral dose of 75 grams (g) aqueous activated charcoal~There was a washout period of at least 3 days between dosing occasions."
11004308|NCT01076179|OG000|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
11004309|NCT01076179|EG000|Reported Event|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
11004310|NCT01076192|BG000|Baseline|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
11004311|NCT01076192|FG000|Participant Flow|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
11004312|NCT01076192|OG000|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
11004313|NCT01076192|OG000|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice
11004314|NCT01076192|EG000|Reported Event|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
11004315|NCT01076205|BG000|Baseline|Adalimumab|Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
11004316|NCT01076205|FG000|Participant Flow|Adalimumab|Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
11004317|NCT01076205|OG000|Outcome|Adalimumab|Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
11004318|NCT01076205|OG000|Outcome|Baseline|Month 0 - at enrollment
11004319|NCT01076205|OG001|Outcome|Month 3|3 months after enrollment
11004320|NCT01076205|OG002|Outcome|Month 6|6 months after enrollment
11004321|NCT01076205|OG003|Outcome|Month 12|12 months after enrollment
11004322|NCT01076205|OG004|Outcome|Month 24|24 months after enrollment
11004323|NCT01076205|OG005|Outcome|Month 36|36 months after enrollment
11004324|NCT01076205|OG006|Outcome|Month 48|48 months after enrollment
11004325|NCT01076205|OG007|Outcome|Month 60|60 months after enrollment
11004326|NCT01076205|OG001|Outcome|Month 6|6 months after enrollment
11004327|NCT01076205|OG002|Outcome|Month 12|12 months after enrollment
11004328|NCT01076205|OG003|Outcome|Month 24|24 months after enrollment
11004329|NCT01076205|OG004|Outcome|Month 36|36 months after enrollment
11004330|NCT01076205|OG005|Outcome|Month 48|48 months after enrollment
11004331|NCT01076205|OG006|Outcome|Month 60|60 months after enrollment
11004332|NCT01076205|OG001|Outcome|Any Visit|From baseline to month 60
11004333|NCT01076205|OG000|Outcome|Month 3|3 months after enrollment
11004334|NCT01076205|EG000|Reported Event|Adalimumab|Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
11004335|NCT01076231|BG000|Baseline|Arm I|"Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity.~Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy.~proton beam radiation therapy~cisplatin: Given IV~etoposide: Given IV~therapeutic conventional surgery"
11004336|NCT01076231|FG000|Participant Flow|Arm I|"Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity.~Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy.~proton beam radiation therapy~cisplatin: Given IV~etoposide: Given IV~therapeutic conventional surgery"
11004337|NCT01076231|OG000|Outcome|Arm I|"Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity.~Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy.~proton beam radiation therapy~cisplatin: Given IV~etoposide: Given IV~therapeutic conventional surgery"
11004338|NCT01076231|EG000|Reported Event|Arm I|"Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity.~Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy.~proton beam radiation therapy~cisplatin: Given IV~etoposide: Given IV~therapeutic conventional surgery"
11004339|NCT01076244|BG000|Baseline|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
11004340|NCT01076244|FG000|Participant Flow|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
11004341|NCT01076244|OG000|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
11004342|NCT01076244|EG000|Reported Event|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
11104491|NCT01609218|FG001|Participant Flow|First LY2140023 + Activated Charcoal, Then LY2140023 Alone|"Period 1: Single oral dose of 80 mg LY2140023 followed 1 hour later by single oral dose of 75 g aqueous activated charcoal~Period 2: Single oral dose of 80 mg LY2140023 administered alone~There was a washout period of at least 3 days between dosing occasions."
11104492|NCT01609218|OG000|Outcome|80 mg LY2140023|Single oral dose of 80 mg LY2140023 administered alone
11104493|NCT01609218|OG001|Outcome|80 mg LY2140023 + 75 g Aqueous Activated Charcoal|Single oral dose of 80 mg LY2140023 followed 1 hour later by single oral dose of 75 g aqueous activated charcoal
11104494|NCT01609218|EG000|Reported Event|80 mg LY2140023|Single oral dose of 80 mg LY2140023 administered alone
11104495|NCT01609218|EG001|Reported Event|80 mg LY2140023 + 75 g Aqueous Activated Charcoal|Single oral dose of 80 mg LY2140023 followed 1 hour later by single oral dose of 75 g aqueous activated charcoal
11104496|NCT01609257|BG000|Baseline|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
11104497|NCT01609257|BG001|Baseline|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
11104498|NCT01609257|BG002|Baseline|Total|Total of all reporting groups
11104499|NCT01609257|FG000|Participant Flow|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
11104500|NCT01609257|FG001|Participant Flow|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
11104501|NCT01609257|OG000|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
11104502|NCT01609257|OG001|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
11104503|NCT01609257|OG000|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
11104504|NCT01609257|OG001|Outcome|Placebo_Not Ill|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
11104505|NCT01609257|OG001|Outcome|Placebo_Not Infected|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
11104506|NCT01609257|EG000|Reported Event|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
11104507|NCT01609257|EG001|Reported Event|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
11104508|NCT01609296|BG000|Baseline|Clinical Cohort ITT|
11104509|NCT01609296|FG000|Participant Flow|Clinical Cohort ITT|
11104510|NCT01609296|OG000|Outcome|Clinical Cohort ITT|
11104511|NCT01609296|OG000|Outcome|Imaging Cohort ITT|
11104512|NCT01609296|OG000|Outcome|150mm DEB ITT Cohort|
11104513|NCT01609296|OG000|Outcome|Clinical Cohort ITT|Death, Major Target Limb Amputation, Clinically-driven TVR, Thrombosis
11104514|NCT01609296|OG000|Outcome|150 mm DEB ITT Cohort|
11104515|NCT01609296|EG000|Reported Event|Clinical Cohort 60M|Events through the entire 60 months follow-up period are included
11104516|NCT01609348|BG000|Baseline|Venlafaxine|"225 mg daily over 12 weeks~Venlafaxine: 225 mg daily for 12 weeks"
11104517|NCT01609348|BG001|Baseline|Sugar Pill|Placebo: Capsule matching active drug to be taken once a day for 12 weeks
11104518|NCT01609348|BG002|Baseline|Total|Total of all reporting groups
11104519|NCT01609348|FG000|Participant Flow|Venlafaxine|"225 mg daily over 12 weeks~Venlafaxine: 225 mg daily for 12 weeks"
11104520|NCT01609348|FG001|Participant Flow|Sugar Pill|Placebo: Capsule matching active drug to be taken once a day for 12 weeks
11104521|NCT01609348|OG000|Outcome|Venlafaxine|"225 mg daily over 12 weeks~Venlafaxine: 225 mg daily for 12 weeks"
11104522|NCT01609348|OG001|Outcome|Sugar Pill|Placebo: Capsule matching active drug to be taken once a day for 12 weeks
11104523|NCT01609348|EG000|Reported Event|Venlafaxine|"225 mg daily over 12 weeks~Venlafaxine: 225 mg daily for 12 weeks"
11104524|NCT01609348|EG001|Reported Event|Sugar Pill|Placebo: Capsule matching active drug to be taken once a day for 12 weeks
11104525|NCT01609478|BG000|Baseline|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104526|NCT01609478|BG001|Baseline|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104527|NCT01609478|BG002|Baseline|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104528|NCT01609478|BG003|Baseline|Total|Total of all reporting groups
11104529|NCT01609478|FG000|Participant Flow|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104530|NCT01609478|FG001|Participant Flow|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104531|NCT01609478|FG002|Participant Flow|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104532|NCT01609478|OG000|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104533|NCT01609478|OG001|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104534|NCT01609478|OG002|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104535|NCT01609478|EG000|Reported Event|Indacaterol Acetate 75 mcg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104536|NCT01609478|EG001|Reported Event|Indacaterol Acetate 150 mcg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104537|NCT01609478|EG002|Reported Event|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
11104538|NCT01609543|BG000|Baseline|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
11104539|NCT01609543|FG000|Participant Flow|Erlotinib Hydrochloride|Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
11104540|NCT01609543|OG000|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity, or consent withdrawal, whichever occurred first up to 34 months.
11104541|NCT01609543|OG000|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
11104542|NCT01609543|EG000|Reported Event|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
11104543|NCT01609556|BG000|Baseline|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)|Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104544|NCT01609556|BG001|Baseline|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)|Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104545|NCT01609556|BG002|Baseline|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104546|NCT01609556|BG003|Baseline|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104547|NCT01609556|BG004|Baseline|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)|Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104548|NCT01609556|BG005|Baseline|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104549|NCT01609556|BG006|Baseline|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104550|NCT01609556|BG007|Baseline|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104551|NCT01609556|BG008|Baseline|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)|Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104552|NCT01609556|BG009|Baseline|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)|Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104553|NCT01609556|BG010|Baseline|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)|Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104554|NCT01609556|BG011|Baseline|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)|Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104555|NCT01609556|BG012|Baseline|Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)|Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104556|NCT01609556|BG013|Baseline|Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)|Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104557|NCT01609556|BG014|Baseline|Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)|Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104558|NCT01609556|BG015|Baseline|Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)|Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104559|NCT01609556|BG016|Baseline|Total|Total of all reporting groups
11104560|NCT01609556|FG000|Participant Flow|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)|Participants received mirvetuximab soravtansine 0.15 milligrams (mg)/kilogram (kg) intravenous (IV) infusion on Day 1 of every 21-day (every 3 weeks [Q3W]) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104561|NCT01609556|FG001|Participant Flow|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)|Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104562|NCT01609556|FG002|Participant Flow|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104563|NCT01609556|FG003|Participant Flow|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104564|NCT01609556|FG004|Participant Flow|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)|Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104565|NCT01609556|FG005|Participant Flow|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104566|NCT01609556|FG006|Participant Flow|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104567|NCT01609556|FG007|Participant Flow|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104568|NCT01609556|FG008|Participant Flow|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)|Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104569|NCT01609556|FG009|Participant Flow|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)|Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104570|NCT01609556|FG010|Participant Flow|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)|Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104571|NCT01609556|FG011|Participant Flow|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)|Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104572|NCT01609556|FG012|Participant Flow|Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)|Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (maximum tolerated dose [MTD]) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11126559|NCT01734161|EG001|Reported Event|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
11126560|NCT01734239|BG000|Baseline|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
11126561|NCT01734239|BG001|Baseline|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
11104573|NCT01609556|FG013|Participant Flow|Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)|Participants with folate receptor 1 (FOLR1)-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104574|NCT01609556|FG014|Participant Flow|Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)|Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104575|NCT01609556|FG015|Participant Flow|Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)|Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104576|NCT01609556|OG000|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)|Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104577|NCT01609556|OG001|Outcome|Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)|Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104578|NCT01609556|OG000|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)|Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104579|NCT01609556|OG001|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)|Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104580|NCT01609556|OG002|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104581|NCT01609556|OG003|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104582|NCT01609556|OG004|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)|Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104583|NCT01609556|OG005|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104584|NCT01609556|OG006|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104585|NCT01609556|OG007|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104586|NCT01609556|OG008|Outcome|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)|Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104587|NCT01609556|OG009|Outcome|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)|Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104588|NCT01609556|OG010|Outcome|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)|Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11126562|NCT01734239|BG002|Baseline|Total|Total of all reporting groups
11104589|NCT01609556|OG011|Outcome|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)|Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104590|NCT01609556|OG012|Outcome|Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)|Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104591|NCT01609556|OG013|Outcome|Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)|Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104592|NCT01609556|OG014|Outcome|Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)|Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104593|NCT01609556|OG015|Outcome|Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)|Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104594|NCT01609556|OG000|Outcome|Mirvetuximab Soravtansine 6.0 mg/kg AIBW|Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
11104595|NCT01609556|OG000|Outcome|Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)|Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104596|NCT01609556|OG001|Outcome|Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)|Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104597|NCT01609556|OG002|Outcome|Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)|Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104598|NCT01609556|OG003|Outcome|Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)|Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104599|NCT01609556|EG000|Reported Event|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)|Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104600|NCT01609556|EG001|Reported Event|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)|Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104601|NCT01609556|EG002|Reported Event|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104602|NCT01609556|EG003|Reported Event|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104603|NCT01609556|EG004|Reported Event|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)|Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11126563|NCT01734239|FG000|Participant Flow|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
11104604|NCT01609556|EG005|Reported Event|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104605|NCT01609556|EG006|Reported Event|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104606|NCT01609556|EG007|Reported Event|Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)|Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104607|NCT01609556|EG008|Reported Event|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)|Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104608|NCT01609556|EG009|Reported Event|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)|Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104609|NCT01609556|EG010|Reported Event|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)|Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104610|NCT01609556|EG011|Reported Event|Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)|Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104611|NCT01609556|EG012|Reported Event|Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)|Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104612|NCT01609556|EG013|Reported Event|Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)|Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104613|NCT01609556|EG014|Reported Event|Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)|Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104614|NCT01609556|EG015|Reported Event|Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)|Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
11104615|NCT01609582|BG000|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
11104616|NCT01609582|BG001|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
11104617|NCT01609582|BG002|Baseline|Total|Total of all reporting groups
11104618|NCT01609582|FG000|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
11104619|NCT01609582|FG001|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
11104620|NCT01609582|OG000|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
11104621|NCT01609582|OG001|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
11104622|NCT01609582|EG000|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
11104623|NCT01609582|EG001|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
11104624|NCT01609933|BG000|Baseline|2-DAA + PegIFN/RBV|2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
11104625|NCT01609933|FG000|Participant Flow|2-DAA + PegIFN/RBV|2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
11126564|NCT01734239|FG001|Participant Flow|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
11104626|NCT01609933|OG000|Outcome|2-DAA + PegIFN/RBV|2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks followed by pegIFN and RBV alone for an additional 24 weeks.
11104627|NCT01609933|OG000|Outcome|2-DAA + PegIFN/RBV|2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
11104628|NCT01609933|OG000|Outcome|2-DAA + PegIFN/RBV|2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID).
11104629|NCT01609933|EG000|Reported Event|2-DAA + PegIFN/RBV|2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
11104630|NCT01610011|BG000|Baseline|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
11104631|NCT01610011|BG001|Baseline|Glycine Administration GLDC Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
11104632|NCT01610011|BG002|Baseline|Total|Total of all reporting groups
11104633|NCT01610011|FG000|Participant Flow|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
11104634|NCT01610011|FG001|Participant Flow|Glycine Administration GLDC Mutation Subjects|Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics. Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage.
11104635|NCT01610011|OG000|Outcome|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
11104636|NCT01610011|OG001|Outcome|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
11104637|NCT01610011|EG000|Reported Event|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
11104638|NCT01610011|EG001|Reported Event|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
11104639|NCT01610037|BG000|Baseline|QVA149|110/50 µg capsules for inhalation, o.d
11104640|NCT01610037|BG001|Baseline|Tiotropium|18 μg capsules for inhalation, o.d
11104641|NCT01610037|BG002|Baseline|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
11104642|NCT01610037|BG003|Baseline|Total|Total of all reporting groups
11104643|NCT01610037|FG000|Participant Flow|QVA149|110/50 µg capsules for inhalation, o.d
11104644|NCT01610037|FG001|Participant Flow|Tiotropium|18 μg capsules for inhalation, o.d
11104645|NCT01610037|FG002|Participant Flow|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
11104646|NCT01610037|OG000|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
11104647|NCT01610037|OG001|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
11104648|NCT01610037|OG002|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
11104649|NCT01610037|EG000|Reported Event|QVA 149|110/50 µg capsules for inhalation, o.d
11104650|NCT01610037|EG001|Reported Event|Tiotropium|18 μg capsules for inhalation, o.d
11104651|NCT01610037|EG002|Reported Event|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
11104652|NCT01610063|BG000|Baseline|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
11104653|NCT01610063|BG001|Baseline|Unguided|Treatment as usual
11104654|NCT01610063|BG002|Baseline|Total|Total of all reporting groups
11104655|NCT01610063|FG000|Participant Flow|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
11104656|NCT01610063|FG001|Participant Flow|Unguided|Treatment as usual
11104657|NCT01610063|OG000|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
11104658|NCT01610063|OG001|Outcome|Unguided|Treatment as usual
11104659|NCT01610063|EG000|Reported Event|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
11104660|NCT01610063|EG001|Reported Event|Unguided|Treatment as usual
11104661|NCT01610076|BG000|Baseline|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
11104662|NCT01610076|BG001|Baseline|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
11104663|NCT01610076|BG002|Baseline|Total|Total of all reporting groups
11104664|NCT01610076|FG000|Participant Flow|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
11104665|NCT01610076|FG001|Participant Flow|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
11104666|NCT01610076|OG000|Outcome|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
11104667|NCT01610076|OG001|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
11104668|NCT01610076|OG000|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
11104669|NCT01610076|EG000|Reported Event|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
11104670|NCT01610076|EG001|Reported Event|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
11104671|NCT01610154|BG000|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg QD for 12 weeks
11104672|NCT01610154|FG000|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg QD for 12 weeks
11104673|NCT01610154|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg QD
11104674|NCT01610154|OG000|Outcome|Non-obese Group|BMI<25 kg/m2
11104675|NCT01610154|OG001|Outcome|Obese Group|BMI≥25 kg/m2
11104676|NCT01610154|EG000|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg QD
11104677|NCT01610167|BG000|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104678|NCT01610167|BG001|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104679|NCT01610167|BG002|Baseline|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104680|NCT01610167|BG003|Baseline|Total|Total of all reporting groups
11104681|NCT01610167|FG000|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104682|NCT01610167|FG001|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104683|NCT01610167|FG002|Participant Flow|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104684|NCT01610167|OG000|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104685|NCT01610167|OG001|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104686|NCT01610167|OG002|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104687|NCT01610167|EG000|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104688|NCT01610167|EG001|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104689|NCT01610167|EG002|Reported Event|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
11104690|NCT01610206|BG000|Baseline|Gemcitabine|Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
11104691|NCT01610206|BG001|Baseline|Gemcitabine + Pazopanib|"Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.~pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles"
11104692|NCT01610206|BG002|Baseline|Total|Total of all reporting groups
11104693|NCT01610206|FG000|Participant Flow|Gemcitabine|Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
11104694|NCT01610206|FG001|Participant Flow|Gemcitabine + Pazopanib|"Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.~pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles"
11104695|NCT01610206|OG000|Outcome|Gemcitabine|Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
11126565|NCT01734239|OG000|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
11104696|NCT01610206|OG001|Outcome|Gemcitabine + Pazopanib|"Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.~pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles"
11104697|NCT01610206|EG000|Reported Event|Gemcitabine|Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
11104698|NCT01610206|EG001|Reported Event|Gemcitabine + Pazopanib|"Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.~pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles"
11104699|NCT01610271|BG000|Baseline|Control|The Air Barrier System will NOT be employed throughout the surgical procedure for this group of patients.
11104700|NCT01610271|BG001|Baseline|Air Barrier System|The Air Barrier System will be employed throughout the surgical procedure for this group of patients.
11104701|NCT01610271|BG002|Baseline|Total|Total of all reporting groups
11104702|NCT01610271|FG000|Participant Flow|Air Barrier System|"The Air Barrier System will be employed throughout the surgical procedure for this group of patients.~Air Barrier System (Nimbic): ABS is a device that emits a stream of purified air over the surgical site creating a barrier that prevents the intrusion of bacteria."
11104703|NCT01610271|FG001|Participant Flow|Control|The Air Barrier System will not be used during the surgical procedure for this group of patients.
11104704|NCT01610271|OG000|Outcome|Control|The Air Barrier System will not be used during the surgical procedure for this group of patients.
11104705|NCT01610271|OG001|Outcome|Air Barrier System|"The Air Barrier System will be employed throughout the surgical procedure for this group of patients.~Air Barrier System: ABS is a device that emits a stream of purified air over the surgical site creating a barrier that prevents the intrusion of bacteria."
11104706|NCT01610271|OG000|Outcome|Control|The Air Barrier System will NOT be employed throughout the surgical procedure for this group of patients.
11104707|NCT01610271|OG001|Outcome|Air Barrier System|The Air Barrier System will be employed throughout the surgical procedure for this group of patients.
11104708|NCT01610271|EG000|Reported Event|Control|The Air Barrier System will NOT be employed throughout the surgical procedure for this group of patients.
11104709|NCT01610271|EG001|Reported Event|Air Barrier System|The Air Barrier System will be employed throughout the surgical procedure for this group of patients.
11104710|NCT01610284|BG000|Baseline|BKM120 100mg + Fulvestrant|BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
11104711|NCT01610284|BG001|Baseline|Placebo + Fulvestrant|BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
11104712|NCT01610284|BG002|Baseline|Total|Total of all reporting groups
11104713|NCT01610284|FG000|Participant Flow|BKM120 100mg + Fulvestrant|BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
11104714|NCT01610284|FG001|Participant Flow|Placebo + Fulvestrant|BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
11104715|NCT01610284|OG000|Outcome|BKM120 100mg + Fulvestrant|BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
11104716|NCT01610284|OG001|Outcome|Placebo + Fulvestrant|BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
11104717|NCT01610284|EG000|Reported Event|BKM120 100 mg + Fulvestrant|BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
11104718|NCT01610284|EG001|Reported Event|Placebo + Fulvestrant|BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
11104719|NCT01610297|BG000|Baseline|ICL670|Oral dose of ICL670 at 10 mg/kg daily
11104720|NCT01610297|FG000|Participant Flow|ICL670|Oral dose of ICL670 at 10 mg/kg daily
11104721|NCT01610297|OG000|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
11104722|NCT01610297|EG000|Reported Event|ICL670|Oral dose of ICL670 at 10 mg/kg daily
11104723|NCT01610336|BG000|Baseline|INC280 100 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104724|NCT01610336|BG001|Baseline|INC280 200 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104725|NCT01610336|BG002|Baseline|INC280 400 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104726|NCT01610336|BG003|Baseline|INC280 800 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104727|NCT01610336|BG004|Baseline|INC280 200 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104728|NCT01610336|BG005|Baseline|INC280 400 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104729|NCT01610336|BG006|Baseline|INC280 600 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104730|NCT01610336|BG007|Baseline|INC280 200 mg Tab BID Phase Ib|tab=tablet; BID=twice daily
11104731|NCT01610336|BG008|Baseline|INC280 400 mg Tab BID Phase Ib|tab=tablet; BID=twice daily
11104732|NCT01610336|BG009|Baseline|INC280 400 mg Cap BID Phase II|cap=capsule; BID=twice daily
11104733|NCT01610336|BG010|Baseline|INC280 400 mg Tab BID Phase II|tab=tablet; BID=twice daily
11104734|NCT01610336|BG011|Baseline|Total|Total of all reporting groups
11104735|NCT01610336|FG000|Participant Flow|INC280 100 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104736|NCT01610336|FG001|Participant Flow|INC280 200 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104737|NCT01610336|FG002|Participant Flow|INC280 400 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104738|NCT01610336|FG003|Participant Flow|INC280 800 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104739|NCT01610336|FG004|Participant Flow|INC280 200 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104740|NCT01610336|FG005|Participant Flow|INC280 400 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104741|NCT01610336|FG006|Participant Flow|INC280 600 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104742|NCT01610336|FG007|Participant Flow|INC280 200 mg Tab BID Phase Ib|tab=tablet; BID=twice daily
11104743|NCT01610336|FG008|Participant Flow|INC280 400 mg Tab BID Phase Ib|tab=tablet; BID=twice daily
11104744|NCT01610336|FG009|Participant Flow|INC280 400 mg Cap BID Phase II|cap=capsule; BID=twice daily
11104745|NCT01610336|FG010|Participant Flow|INC280 400 mg Tab BID Phase II|tab=tablet; BID=twice daily
11104746|NCT01610336|OG000|Outcome|INC280 100 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104747|NCT01610336|OG001|Outcome|INC280 200 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104748|NCT01610336|OG002|Outcome|INC280 400 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104749|NCT01610336|OG003|Outcome|INC280 800 mg Cap QD Phase Ib|cap=capsule; QD=once daily
11104750|NCT01610336|OG004|Outcome|INC280 200 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104751|NCT01610336|OG005|Outcome|INC280 400 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104752|NCT01610336|OG006|Outcome|INC280 600 mg Cap BID Phase Ib|cap=capsule; BID=twice daily
11104753|NCT01610336|OG007|Outcome|INC280 200 mg Tab BID Phase Ib|tab=tablet; BID=twice daily
11104754|NCT01610336|OG008|Outcome|INC280 400 mg Tab BID Phase Ib|tab=tablet; BID=twice daily
11104755|NCT01610336|OG000|Outcome|INC280 400 mg Cap BID Phase II|cap=capsule; BID=twice daily
11104756|NCT01610336|OG001|Outcome|INC280 400 mg Tab BID Phase II|tab=tablet; BID=twice daily
11104757|NCT01610336|OG009|Outcome|INC280 400 mg Cap BID Phase II|cap=capsule; BID=twice daily
11104758|NCT01610336|OG010|Outcome|INC280 400 mg Tab BID Phase II|tab=tablet; BID=twice daily
11104759|NCT01610336|OG009|Outcome|mg Cap BID Phase II|cap=capsule; BID=twice daily
11104760|NCT01610336|OG010|Outcome|INC280 400 mg Tab BID Phase II|
11104761|NCT01610336|EG000|Reported Event|100 mg Cap QD (Ph Ib)|100 mg Cap QD (Ph Ib)
11104762|NCT01610336|EG001|Reported Event|200 mg Cap QD (Ph Ib)|200 mg Cap QD (Ph Ib)
11104763|NCT01610336|EG002|Reported Event|400 mg Cap QD (Ph Ib)|400 mg Cap QD (Ph Ib)
11104764|NCT01610336|EG003|Reported Event|800 mg Cap QD (Ph Ib)|800 mg Cap QD (Ph Ib)
11104765|NCT01610336|EG004|Reported Event|200 mg Cap BID (Ph Ib)|200 mg Cap BID (Ph Ib)
11104766|NCT01610336|EG005|Reported Event|400 mg Cap BID (Ph Ib)|400 mg Cap BID (Ph Ib)
11104767|NCT01610336|EG006|Reported Event|600 mg Cap BID (Ph Ib)|600 mg Cap BID (Ph Ib)
11104768|NCT01610336|EG007|Reported Event|200 mg Tab BID (Ph Ib)|200 mg Tab BID (Ph Ib)
11104769|NCT01610336|EG008|Reported Event|400 mg Tab BID (Ph Ib)|400 mg Tab BID (Ph Ib)
11104770|NCT01610336|EG009|Reported Event|400 mg Cap BID (Ph II)|400 mg Cap BID (Ph II)
11104771|NCT01610336|EG010|Reported Event|400 mg Tab BID (Ph II)|400 mg Tab BID (Ph II)
11104772|NCT01610414|BG000|Baseline|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
11104773|NCT01610414|BG001|Baseline|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
11104774|NCT01610414|BG002|Baseline|Total|Total of all reporting groups
11104775|NCT01610414|FG000|Participant Flow|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
11104776|NCT01610414|FG001|Participant Flow|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
11104777|NCT01610414|OG000|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
11104778|NCT01610414|OG001|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
11104779|NCT01610414|OG002|Outcome|No Group|Subjects who were not assigned to any group (subjects from pre-vaccination visit).
11104780|NCT01610414|EG000|Reported Event|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
11104781|NCT01610414|EG001|Reported Event|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
11104782|NCT01610427|BG000|Baseline|HIV-1 Group|Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
11104783|NCT01610427|FG000|Participant Flow|HIV-1 Group|Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
11104784|NCT01610427|OG000|Outcome|HIV-1 Group|Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
11104785|NCT01610427|EG000|Reported Event|HIV-1 Group|Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
11104786|NCT01610453|BG000|Baseline|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
11104787|NCT01610453|FG000|Participant Flow|Results From Transperineal Scan|"Primiparous women with prolonged labours was eligible for the study. Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK and Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway participated.~Ultrasound examination: a transperineal sonography was done when prolonged labor was diagnosed. Prolonged labor was diagnosed in accordance with WHO recommendations in Stavanger and in accordance with NICE guidelines in Cambridge"
11104788|NCT01610453|OG000|Outcome|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
11104789|NCT01610453|OG000|Outcome|Transabdominal Ultrasound|Fetal head position was assessed using a transabdominal scan
11104790|NCT01610453|EG000|Reported Event|Transabdominal and Transperineal Sonography|Fetal head position was assessed using a transabdominal scan and fetal station was assessed by transperineal scan
11126566|NCT01734239|OG001|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
11126567|NCT01734239|EG000|Reported Event|Pneumovax™ 23|Participants received a single 0.5 mL intramuscular injection on Day 1
11104791|NCT01610492|BG000|Baseline|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
11104792|NCT01610492|FG000|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
11104793|NCT01610492|OG000|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
11104794|NCT01610492|EG000|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
11104795|NCT01610557|BG000|Baseline|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104796|NCT01610557|BG001|Baseline|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104797|NCT01610557|BG002|Baseline|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104798|NCT01610557|BG003|Baseline|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104799|NCT01610557|BG004|Baseline|Total|Total of all reporting groups
11104800|NCT01610557|FG000|Participant Flow|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104801|NCT01610557|FG001|Participant Flow|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104802|NCT01610557|FG002|Participant Flow|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104803|NCT01610557|FG003|Participant Flow|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
10846749|NCT00279708|FG001|Participant Flow|Control Group (Placebo)|Placebo In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
11104804|NCT01610557|FG004|Participant Flow|Ranibizumab/Bevacizumab As Needed|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~53 participants attended at least one follow-up visit in the post-36-week extension phase: 49 participants who had one eye enrolled and 4 participants who had two eyes enrolled."
11104805|NCT01610557|OG000|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
11104806|NCT01610557|OG001|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
11104807|NCT01610557|EG000|Reported Event|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104808|NCT01610557|EG001|Reported Event|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104809|NCT01610557|EG002|Reported Event|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104810|NCT01610557|EG003|Reported Event|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
11104811|NCT01610557|EG004|Reported Event|Ranibizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis.~Participants with one eye assigned in either Group 1 or Group 2 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom two eyes were assigned (bilateral participants) are not included."
11104812|NCT01610557|EG005|Reported Event|Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~Participants with one eye assigned in either Group 3 or Group 4 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom two eyes were assigned (bilateral participants) are not included."
11104813|NCT01610557|EG006|Reported Event|Ranibizumab and Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~Participants with two eyes assigned who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom one eye was assigned (unilateral participants) are not included."
11104814|NCT01610570|BG000|Baseline|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
11104815|NCT01610570|BG001|Baseline|Phase 1 Dose Level 1|Dose Escalation Phase 13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
11126568|NCT01734317|BG000|Baseline|Mepilex Transfer Ag|
11126569|NCT01734317|FG000|Participant Flow|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
11104816|NCT01610570|BG002|Baseline|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
11104817|NCT01610570|BG003|Baseline|Phase 2|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
11104818|NCT01610570|BG004|Baseline|Total|Total of all reporting groups
11104819|NCT01610570|FG000|Participant Flow|Phase I Dose Level -1|"Dose Escalation Phase~9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
11104820|NCT01610570|FG001|Participant Flow|Phase 1 Dose Level 1|"Dose Escalation Phase~13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
11104821|NCT01610570|FG002|Participant Flow|Phase 1 Dose Level 2|"Dose Escalation Phase~17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
11104822|NCT01610570|FG003|Participant Flow|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
11104823|NCT01610570|OG000|Outcome|Phase I Dose Level -1|Dose Escalation Ph 9.0 mcg/kg dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104824|NCT01610570|OG001|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11126570|NCT01734317|OG000|Outcome|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
11104825|NCT01610570|OG002|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104826|NCT01610570|OG000|Outcome|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104827|NCT01610570|OG003|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104828|NCT01610570|OG000|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104829|NCT01610570|OG000|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104830|NCT01610570|OG001|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104831|NCT01610570|OG002|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11126571|NCT01734317|OG000|Outcome|Pain Measure|
11126572|NCT01734317|EG000|Reported Event|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
11104832|NCT01610570|OG000|Outcome|Phase I Dose Level 1 & Phase II Expansion Phase|Dose levels 13.0 and 17.5 mcg/kg. dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104833|NCT01610570|EG000|Reported Event|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104834|NCT01610570|EG001|Reported Event|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104835|NCT01610570|EG002|Reported Event|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104836|NCT01610570|EG003|Reported Event|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
11104837|NCT01610596|BG000|Baseline|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
11104838|NCT01610596|BG001|Baseline|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
11104839|NCT01610596|BG002|Baseline|Total|Total of all reporting groups
11104840|NCT01610596|FG000|Participant Flow|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
11104841|NCT01610596|FG001|Participant Flow|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
11104842|NCT01610596|OG000|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
11104843|NCT01610596|OG001|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
11104844|NCT01610596|EG000|Reported Event|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
11104845|NCT01610596|EG001|Reported Event|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
11104846|NCT01610687|BG000|Baseline|GW-1000-02|Active treatment
11104847|NCT01610687|FG000|Participant Flow|GW-1000-02|GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
11104848|NCT01610687|OG000|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
11104849|NCT01610687|EG000|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
11104850|NCT01610700|BG000|Baseline|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104851|NCT01610700|BG001|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
11104852|NCT01610700|BG002|Baseline|Total|Total of all reporting groups
11104853|NCT01610700|FG000|Participant Flow|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104854|NCT01610700|FG001|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
11104855|NCT01610700|OG000|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104856|NCT01610700|OG001|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
11104857|NCT01610700|OG000|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104858|NCT01610700|EG000|Reported Event|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104859|NCT01610700|EG001|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
11104860|NCT01610713|BG000|Baseline|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104861|NCT01610713|BG001|Baseline|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104862|NCT01610713|BG002|Baseline|Total|Total of all reporting groups
11104863|NCT01610713|FG000|Participant Flow|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104864|NCT01610713|FG001|Participant Flow|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104865|NCT01610713|OG000|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104866|NCT01610713|OG001|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104867|NCT01610713|EG000|Reported Event|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104868|NCT01610713|EG001|Reported Event|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
11104869|NCT01610752|BG000|Baseline|SmartMoms-Clinic|"If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.~SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits."
11104870|NCT01610752|BG001|Baseline|SmartMoms-Phone|"If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.~SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits."
11104871|NCT01610752|BG002|Baseline|Physician Directed|If picked for this group, you will receive weight management advice from your physician's office.
11104872|NCT01610752|BG003|Baseline|Total|Total of all reporting groups
11104873|NCT01610752|FG000|Participant Flow|SmartMoms-Clinic|"If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.~SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits."
11104874|NCT01610752|FG001|Participant Flow|SmartMoms-Phone|"If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.~SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits."
11104875|NCT01610752|FG002|Participant Flow|Physician Directed|If picked for this group, you will receive weight management advice from your physician's office.
11104876|NCT01610752|OG000|Outcome|SmartMoms-Clinic|"If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.~SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits."
11104877|NCT01610752|OG001|Outcome|SmartMoms-Phone|"If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.~SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits."
11104878|NCT01610752|OG002|Outcome|Physician Directed|If picked for this group, you will receive weight management advice from your physician's office.
11104879|NCT01610752|EG000|Reported Event|SmartMoms-Clinic|"If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.~SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits."
11104880|NCT01610752|EG001|Reported Event|SmartMoms-Phone|"If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.~SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits."
11104881|NCT01610752|EG002|Reported Event|Physician Directed|If picked for this group, you will receive weight management advice from your physician's office.
11104882|NCT01610791|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
11104883|NCT01610791|FG000|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg), intravenously (IV), once every 4 weeks for a total of 6 infusions.
11104884|NCT01610791|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
11104885|NCT01610791|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
11104886|NCT01611090|BG000|Baseline|Ibrutinib+BR|Participants received ibrutinib 420 milligram (mg) (3 * 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
11104887|NCT01611090|BG001|Baseline|Placebo+BR|Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
11104888|NCT01611090|BG002|Baseline|Total|Total of all reporting groups
11104889|NCT01611090|FG000|Participant Flow|Ibrutinib+BR|Participants received ibrutinib 420 milligram (mg) (3 * 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
11104890|NCT01611090|FG001|Participant Flow|Placebo+BR|Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
11104891|NCT01611090|FG002|Participant Flow|Crossover to Ibrutinib|Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg [3 * 140 mg capsules] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.
11104892|NCT01611090|OG000|Outcome|Ibrutinib+BR|Participants received ibrutinib 420 milligram (mg) (3 * 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
10879524|NCT00458341|FG001|Participant Flow|Ataluren 10, 10, and 20 mg/kg, Then Ataluren 4, 4, and 8 mg/kg|During Cycle 1, participants received ataluren at 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. Then, the participants crossed over to the other ataluren dose regimen (ataluren 4, 4, and 8 mg/kg) for Cycle 2.
11104893|NCT01611090|OG001|Outcome|Placebo+BR|Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
11104894|NCT01611090|EG000|Reported Event|Ibrutinib+BR|Participants received ibrutinib 420 milligram (mg) (3 * 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
11104895|NCT01611090|EG001|Reported Event|Placebo+BR|Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
11104896|NCT01611090|EG002|Reported Event|Crossover to Ibrutinib|Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg [3 * 140 mg capsules] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.
11104897|NCT01611155|BG000|Baseline|Arm I (Venlafaxine)|Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.
11104898|NCT01611155|BG001|Baseline|Arm II (Placebo)|Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
11104899|NCT01611155|BG002|Baseline|Total|Total of all reporting groups
11104900|NCT01611155|FG000|Participant Flow|Arm I (Venlafaxine)|Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.
11104901|NCT01611155|FG001|Participant Flow|Arm II (Placebo)|Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
11104902|NCT01611155|OG000|Outcome|Arm I (Venlafaxine)|Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.
11104903|NCT01611155|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
11104904|NCT01611155|EG000|Reported Event|Arm I (Venlafaxine)|Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.
11104905|NCT01611155|EG001|Reported Event|Arm II (Placebo)|Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
11104906|NCT01611194|BG000|Baseline|HBO2 at 1.5 Atomspheres Absolute (ATA)|"Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.~Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week."
11126573|NCT01734382|BG000|Baseline|Part 1: Tocilizumab (TCZ) Q2W|Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants < 30 kg; 8 mg/kg for participants >/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study.
11224511|NCT02360475|FG003|Participant Flow|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11104907|NCT01611194|BG001|Baseline|Sham Control (1.2 Atomspheres)|"Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).~Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs)."
11104908|NCT01611194|BG002|Baseline|Total|Total of all reporting groups
11104909|NCT01611194|FG000|Participant Flow|HBO2 at 1.5 Atomspheres Absolute (ATA)|"Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.~Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week."
11104910|NCT01611194|FG001|Participant Flow|Sham Control (1.2 Atomspheres)|"Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).~Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs)."
11104911|NCT01611194|OG000|Outcome|HBO2 at 1.5 Atomspheres Absolute (ATA)|"Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.~Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week."
11104912|NCT01611194|OG001|Outcome|Sham Control (1.2 Atomspheres)|"Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).~Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs)."
11104913|NCT01611194|EG000|Reported Event|HBO2 at 1.5 Atomspheres Absolute (ATA)|"Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.~Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week."
11104914|NCT01611194|EG001|Reported Event|Sham Control (1.2 Atomspheres)|"Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).~Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs)."
11104915|NCT01611259|BG000|Baseline|Rituximab and Lenalidomide|Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.
11104916|NCT01611259|FG000|Participant Flow|Rituximab and Lenalidomide|Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.
11104917|NCT01611259|OG000|Outcome|Rituximab and Lenalidomide|Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.
11104918|NCT01611259|EG000|Reported Event|Rituximab and Lenalidomide|Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.
11104919|NCT01611298|BG000|Baseline|Single Arm: Tetanus Toxoid|"SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest~Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.~Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).~Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection."
11104920|NCT01611298|FG000|Participant Flow|Single Arm: Tetanus Toxoid|"SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest~Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.~Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).~Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection."
11104921|NCT01611298|OG000|Outcome|Single Arm: Tetanus Toxoid|"SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest~Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.~Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).~Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection."
11104922|NCT01611298|EG000|Reported Event|Single Arm: Tetanus Toxoid|"SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest~Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.~Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).~Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection."
11104923|NCT01611454|BG000|Baseline|XPF Thyroid Collar|"Administration of the XPF Thyroid Collar.~XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions."
11104924|NCT01611454|BG001|Baseline|Equivalent Collar|"Administration of the Standard 0.5mm lead-equivalent thyroid collar.~Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions."
11104925|NCT01611454|BG002|Baseline|Total|Total of all reporting groups
11104926|NCT01611454|FG000|Participant Flow|XPF Thyroid Collar|"Administration of the XPF Thyroid Collar.~XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions."
11104927|NCT01611454|FG001|Participant Flow|Equivalent Collar|"Administration of the Standard 0.5mm lead-equivalent thyroid collar.~Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions."
11104928|NCT01611454|OG000|Outcome|XPF Thyroid Collar|"Administration of the XPF Thyroid Collar.~XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions."
11104929|NCT01611454|OG001|Outcome|Equivalent Collar|"Administration of the Standard 0.5mm lead-equivalent thyroid collar.~Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions."
11104930|NCT01611454|OG000|Outcome|Dose Measured Outside Collar|Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. It will be measured based on uSv's.
11104931|NCT01611454|OG001|Outcome|Dose Measured Inside Collar|Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. It will be measured based on uSv's.
11104932|NCT01611454|OG000|Outcome|Dose Measured Outside Cap|Radiation exposure will be monitored with radiation detectors outside the cap, which the participant is required to wear. It will be measured based on uSv's.
11104933|NCT01611454|OG001|Outcome|Dose Measured Inside Cap|Radiation exposure will be monitored with radiation detectors inside the cap, which the participant is required to wear. It will be measured based on uSv's.
11104934|NCT01611454|EG000|Reported Event|XPF Thyroid Collar|"Administration of the XPF Thyroid Collar.~XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions."
11104935|NCT01611454|EG001|Reported Event|Equivalent Collar|"Administration of the Standard 0.5mm lead-equivalent thyroid collar.~Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions."
11104936|NCT01611558|BG000|Baseline|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
11104937|NCT01611558|FG000|Participant Flow|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
11104938|NCT01611558|OG000|Outcome|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
11104939|NCT01611558|OG000|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
11104940|NCT01611558|EG000|Reported Event|10 mg/kg Ipilimumab|
11104941|NCT01611571|BG000|Baseline|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
11104942|NCT01611571|BG001|Baseline|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
11104943|NCT01611571|BG002|Baseline|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
11104944|NCT01611571|BG003|Baseline|Total|Total of all reporting groups
11104945|NCT01611571|FG000|Participant Flow|Active Risedronate + Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
11104946|NCT01611571|FG001|Participant Flow|Active Risedronte + Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
11104947|NCT01611571|FG002|Participant Flow|Placebo Risedronate + Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
11104948|NCT01611571|OG000|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
11104949|NCT01611571|OG001|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
11104950|NCT01611571|OG002|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
11104951|NCT01611571|EG000|Reported Event|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
11104952|NCT01611571|EG001|Reported Event|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
11104953|NCT01611571|EG002|Reported Event|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
11104954|NCT01611662|BG000|Baseline|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
11104955|NCT01611662|FG000|Participant Flow|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
11104956|NCT01611662|OG000|Outcome|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
11104957|NCT01611662|EG000|Reported Event|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
11104958|NCT01611779|BG000|Baseline|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
11104959|NCT01611779|FG000|Participant Flow|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
11104960|NCT01611779|OG000|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
11104961|NCT01611779|EG000|Reported Event|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
11224512|NCT02360475|OG000|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11104962|NCT01611792|BG000|Baseline|Stabilization|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
11104963|NCT01611792|BG001|Baseline|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
11104964|NCT01611792|BG002|Baseline|Total|Total of all reporting groups
11104965|NCT01611792|FG000|Participant Flow|Low Back Pain|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
11104966|NCT01611792|FG001|Participant Flow|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
11104967|NCT01611792|OG000|Outcome|Stabilization|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
11104968|NCT01611792|OG001|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
11104969|NCT01611792|OG000|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
11126574|NCT01734382|BG001|Baseline|Part 2: TCZ IV 12 mg/kg Q3W/Q4W|Participants with weight < 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.
11104970|NCT01611792|EG000|Reported Event|Stabilization|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
11104971|NCT01611792|EG001|Reported Event|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
11104972|NCT01611857|BG000|Baseline|Tivantinib+FOLFOX Dose Escalation|"Tivantinib: (120 mg, 240 mg, or 360 mg) orally, twice daily on Days 1-14 of each 2 week cycle.~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
11104973|NCT01611857|BG001|Baseline|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.~Treatment continued until disease progression or unacceptable toxicity."
11104974|NCT01611857|BG002|Baseline|Total|Total of all reporting groups
11104975|NCT01611857|FG000|Participant Flow|Tivantinib + FOLFOX Dose Escalation|"Tivantinib: (120 mg; 240 mg; or 360 mg) orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle;~FOLFOX: [5-Fluorouracil (5-FU) 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2] on Day 1 each cycle."
11104976|NCT01611857|FG001|Participant Flow|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle.~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle."
11104977|NCT01611857|OG000|Outcome|Tivantinib 120 mg (PO BID) + FOLFOX|"Tivantinib 120 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
11104978|NCT01611857|OG001|Outcome|Tivantinib 240 mg (PO BID) + FOLFOX|"Tivantinib 240 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
11104979|NCT01611857|OG002|Outcome|Tivantinib 360 mg (PO BID) + FOLFOX|"Tivantinib 360 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
11104980|NCT01611857|OG000|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
11104981|NCT01611857|EG000|Reported Event|Tivantinib+FOLFOX Dose Escalation|Tivantinib: orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle; FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle.
11104982|NCT01611857|EG001|Reported Event|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.~Treatment continued until disease progression or unacceptable toxicity."
11104983|NCT01611935|BG000|Baseline|Vasopressin|"Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg~Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours."
11104984|NCT01611935|BG001|Baseline|Normal Saline|"An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.~Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours."
11104985|NCT01611935|BG002|Baseline|Total|Total of all reporting groups
11104986|NCT01611935|FG000|Participant Flow|Vasopressin|"Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg~Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours."
11104987|NCT01611935|FG001|Participant Flow|Normal Saline|"An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.~Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours."
11104988|NCT01611935|OG000|Outcome|Vasopressin|"Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg~Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours."
11104989|NCT01611935|OG001|Outcome|Normal Saline|"An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.~Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours."
11104990|NCT01611935|EG000|Reported Event|Vasopressin|"Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg~Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours."
11104991|NCT01611935|EG001|Reported Event|Normal Saline|"An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.~Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours."
11104992|NCT01611948|BG000|Baseline|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11104993|NCT01611948|BG001|Baseline|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11104994|NCT01611948|BG002|Baseline|Total|Total of all reporting groups
11104995|NCT01611948|FG000|Participant Flow|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11104996|NCT01611948|FG001|Participant Flow|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11104997|NCT01611948|OG000|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11104998|NCT01611948|OG001|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11104999|NCT01611948|EG000|Reported Event|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11105000|NCT01611948|EG001|Reported Event|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11105001|NCT01611974|BG000|Baseline|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105002|NCT01611974|BG001|Baseline|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105003|NCT01611974|BG002|Baseline|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105004|NCT01611974|BG003|Baseline|Total|Total of all reporting groups
11105005|NCT01611974|FG000|Participant Flow|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105006|NCT01611974|FG001|Participant Flow|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105007|NCT01611974|FG002|Participant Flow|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105008|NCT01611974|OG000|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105009|NCT01611974|OG001|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105010|NCT01611974|OG002|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105011|NCT01611974|EG000|Reported Event|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105012|NCT01611974|EG001|Reported Event|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105013|NCT01611974|EG002|Reported Event|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
11105014|NCT01612000|BG000|Baseline|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105015|NCT01612000|BG001|Baseline|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105016|NCT01612000|BG002|Baseline|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
11105017|NCT01612000|BG003|Baseline|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105018|NCT01612000|BG004|Baseline|Total|Total of all reporting groups
11105019|NCT01612000|FG000|Participant Flow|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105020|NCT01612000|FG001|Participant Flow|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105021|NCT01612000|FG002|Participant Flow|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
11105022|NCT01612000|FG003|Participant Flow|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105023|NCT01612000|OG000|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105024|NCT01612000|OG001|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105025|NCT01612000|OG002|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
11105026|NCT01612000|OG003|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105027|NCT01612000|EG000|Reported Event|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105028|NCT01612000|EG001|Reported Event|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105029|NCT01612000|EG002|Reported Event|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
11105030|NCT01612000|EG003|Reported Event|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11105031|NCT01612156|BG000|Baseline|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
11105032|NCT01612156|BG001|Baseline|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
11105033|NCT01612156|BG002|Baseline|Total|Total of all reporting groups
11105034|NCT01612156|FG000|Participant Flow|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
11105035|NCT01612156|FG001|Participant Flow|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
11105036|NCT01612156|OG000|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
11105037|NCT01612156|OG001|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
11105038|NCT01612156|EG000|Reported Event|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
11105039|NCT01612156|EG001|Reported Event|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
11105040|NCT01612221|BG000|Baseline|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
11105041|NCT01612221|BG001|Baseline|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
11105042|NCT01612221|BG002|Baseline|Total|Total of all reporting groups
11105043|NCT01612221|FG000|Participant Flow|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
11105044|NCT01612221|FG001|Participant Flow|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
11105045|NCT01612221|OG000|Outcome|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
11105046|NCT01612221|OG001|Outcome|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
11105047|NCT01612221|EG000|Reported Event|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
11105048|NCT01612221|EG001|Reported Event|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
11105049|NCT01612494|BG000|Baseline|Normal Saline|
11105050|NCT01612494|BG001|Baseline|Hypertonic Saline|
11105051|NCT01612494|BG002|Baseline|Total|Total of all reporting groups
11105052|NCT01612494|FG000|Participant Flow|Normal Saline|
11105053|NCT01612494|FG001|Participant Flow|Hypertonic Saline|
11105054|NCT01612494|OG000|Outcome|Normal Saline|
11105055|NCT01612494|OG001|Outcome|Hypertonic Saline|
11105056|NCT01612494|EG000|Reported Event|Normal Saline|
11105057|NCT01612494|EG001|Reported Event|Hypertonic Saline|
11105058|NCT01612546|BG000|Baseline|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
11105059|NCT01612546|FG000|Participant Flow|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
11105060|NCT01612546|OG000|Outcome|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
11105061|NCT01612546|EG000|Reported Event|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
11105062|NCT01612676|BG000|Baseline|Infusion Regimen 1|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105063|NCT01612676|BG001|Baseline|Infusion Regimen 2|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105064|NCT01612676|BG002|Baseline|Infusion Regimen 3|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105065|NCT01612676|BG003|Baseline|Infusion Regimen 4|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105066|NCT01612676|BG004|Baseline|Total|Total of all reporting groups
11105067|NCT01612676|FG000|Participant Flow|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105068|NCT01612676|FG001|Participant Flow|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105069|NCT01612676|FG002|Participant Flow|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105070|NCT01612676|FG003|Participant Flow|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105071|NCT01612676|OG000|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105072|NCT01612676|OG001|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105073|NCT01612676|OG002|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105074|NCT01612676|OG003|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105075|NCT01612676|OG000|Outcome|Full Analysis Set|The full analysis data set (FAS) comprised data from all dosed patients.
11105076|NCT01612676|EG000|Reported Event|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105077|NCT01612676|EG001|Reported Event|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105078|NCT01612676|EG002|Reported Event|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105079|NCT01612676|EG003|Reported Event|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
11105080|NCT01612676|EG004|Reported Event|Total|Summation of adverse events in all treatment arms
11105081|NCT01612702|BG000|Baseline|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
11105082|NCT01612702|BG001|Baseline|Control|No dexamethasone
11105083|NCT01612702|BG002|Baseline|Total|Total of all reporting groups
11105084|NCT01612702|FG000|Participant Flow|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
11105085|NCT01612702|FG001|Participant Flow|Control|No dexamethasone
11105086|NCT01612702|OG000|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
11105087|NCT01612702|OG001|Outcome|Control|No dexamethasone
11105088|NCT01612702|EG000|Reported Event|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
11105089|NCT01612702|EG001|Reported Event|Control|No dexamethasone
11105090|NCT01612767|BG000|Baseline|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105091|NCT01612767|FG000|Participant Flow|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105092|NCT01612767|OG000|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105093|NCT01612767|OG000|Outcome|PRO-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105094|NCT01612767|OG000|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105095|NCT01612767|OG001|Outcome|PRO-Kinetic Energy Stent - 12 Months|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105096|NCT01612767|OG002|Outcome|PRO-Kinetic Energy Stent - 24 Months|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105097|NCT01612767|OG003|Outcome|PRO-Kinetic Energy Stent - 36 Months|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105098|NCT01612767|OG000|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105099|NCT01612767|OG001|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105100|NCT01612767|OG002|Outcome|PRO-Kinetic Energy Stent - 12 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105101|NCT01612767|OG003|Outcome|PRO-Kinetic Energy Stent - 24 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105102|NCT01612767|OG004|Outcome|PRO-Kinetic Energy Stent - 36 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105103|NCT01612767|OG002|Outcome|Pro-Kinetic Energy Stent - 12 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105104|NCT01612767|OG003|Outcome|Pro-Kinetic Energy Stent - 24 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105105|NCT01612767|OG004|Outcome|Pro-Kinetic Energy Stent - 36 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105106|NCT01612767|OG003|Outcome|PRO-Kinetic Energy Stent -24 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105107|NCT01612767|OG000|Outcome|Pro-Kinetic Energy Stent - Baseline|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105108|NCT01612767|OG001|Outcome|PRO-Kinetic Energy Stent - Discharge|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105109|NCT01612767|OG002|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105110|NCT01612767|OG003|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105111|NCT01612767|OG004|Outcome|PRO-Kinetic Energy Stent - 12 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105112|NCT01612767|OG005|Outcome|PRO-Kinetic Energy Stent - 24 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105113|NCT01612767|OG006|Outcome|PRO-Kinetic Energy Stent - 36 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105114|NCT01612767|EG000|Reported Event|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
11105115|NCT01612780|BG000|Baseline|Balloon Sinus Dilation|Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
11105116|NCT01612780|FG000|Participant Flow|Balloon Sinus Dilation|Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
11105117|NCT01612780|OG000|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
11105118|NCT01612780|EG000|Reported Event|Balloon Sinus Dilation|Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
11105119|NCT01612793|BG000|Baseline|AlphaCore Active Device|"AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.~AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization"
11105120|NCT01612793|BG001|Baseline|AlphaCore Sham Device|"AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.~AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization"
11105121|NCT01612793|BG002|Baseline|Total|Total of all reporting groups
11105122|NCT01612793|FG000|Participant Flow|AlphaCore Active Device|"AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.~AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization"
11105123|NCT01612793|FG001|Participant Flow|AlphaCore Sham Device|"AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.~AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization"
11105124|NCT01612793|OG000|Outcome|AlphaCore Active Device|"AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.~AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization"
11105125|NCT01612793|OG001|Outcome|AlphaCore Sham Device|"AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.~AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization"
11105126|NCT01612793|EG000|Reported Event|AlphaCore Active Device|"AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.~AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization"
11105127|NCT01612793|EG001|Reported Event|AlphaCore Sham Device|"AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.~AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization"
11105128|NCT01612858|BG000|Baseline|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
11105129|NCT01612858|BG001|Baseline|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
11105130|NCT01612858|BG002|Baseline|Total|Total of all reporting groups
11105131|NCT01612858|FG000|Participant Flow|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
11105132|NCT01612858|FG001|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
11105133|NCT01612858|OG000|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
11105134|NCT01612858|OG001|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
11105135|NCT01612858|EG000|Reported Event|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
11105136|NCT01612858|EG001|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
11105137|NCT01612884|BG000|Baseline|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
11105138|NCT01612884|BG001|Baseline|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
11105139|NCT01612884|BG002|Baseline|Total|Total of all reporting groups
11105140|NCT01612884|FG000|Participant Flow|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
11105141|NCT01612884|FG001|Participant Flow|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
11105142|NCT01612884|OG000|Outcome|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
11105143|NCT01612884|OG001|Outcome|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
11105144|NCT01612884|EG000|Reported Event|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
11105145|NCT01612884|EG001|Reported Event|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
11105146|NCT01613014|BG000|Baseline|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
11105147|NCT01613014|BG001|Baseline|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
11105148|NCT01613014|BG002|Baseline|Total|Total of all reporting groups
11105149|NCT01613014|FG000|Participant Flow|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
11105150|NCT01613014|FG001|Participant Flow|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
11105151|NCT01613014|OG000|Outcome|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
11105152|NCT01613014|OG001|Outcome|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
11105153|NCT01613014|EG000|Reported Event|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
11105154|NCT01613014|EG001|Reported Event|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
11105155|NCT01613027|BG000|Baseline|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
11105156|NCT01613027|FG000|Participant Flow|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
11105157|NCT01613027|OG000|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
11105158|NCT01613027|EG000|Reported Event|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
11105159|NCT01613131|BG000|Baseline|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
11105160|NCT01613131|BG001|Baseline|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
11105161|NCT01613131|BG002|Baseline|Total|Total of all reporting groups
11105162|NCT01613131|FG000|Participant Flow|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
11105163|NCT01613131|FG001|Participant Flow|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
11105164|NCT01613131|OG000|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
11105165|NCT01613131|OG001|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
11105166|NCT01613131|EG000|Reported Event|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
11105167|NCT01613131|EG001|Reported Event|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
11105168|NCT01613222|BG000|Baseline|Pulse Oximetry Monitoring|Pulse Oximetry Monitoring Single Arm
11105169|NCT01613222|FG000|Participant Flow|Pulse Oximetry Monitoring|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105170|NCT01613222|OG000|Outcome|Pulse Oximetry Monitoring Using SpO@ Sensors|Pulse oximetry measurement using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105171|NCT01613222|EG000|Reported Event|TS-AAW Sensor + 3900 Oximeter|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105172|NCT01613222|EG001|Reported Event|TS-AAW Sensor + B40 Patient Monitor|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105173|NCT01613222|EG002|Reported Event|TS-AAW Sensor + Carescape V100 With TruSignal V2 SpO2 Board|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105174|NCT01613222|EG003|Reported Event|TS-AAW Sensor + Carescape V100|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105175|NCT01613222|EG004|Reported Event|TS-AAW Sensor + EPRESTN|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105176|NCT01613222|EG005|Reported Event|TS-AAW Sensor + M-NESTPR|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105177|NCT01613222|EG006|Reported Event|TS-AAW Sensor + M-OSAT|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105178|NCT01613222|EG007|Reported Event|TS-AAW Sensor + TruSat|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105179|NCT01613222|EG008|Reported Event|TS-AAW Sensor + TuffSat|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105180|NCT01613222|EG009|Reported Event|TS-SA-D Sensor + Carescape V100 With TruSignal V2 SpO2 Board|Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
11105181|NCT01613248|BG000|Baseline|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105182|NCT01613248|BG001|Baseline|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105183|NCT01613248|BG002|Baseline|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105184|NCT01613248|BG003|Baseline|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105185|NCT01613248|BG004|Baseline|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105186|NCT01613248|BG005|Baseline|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105187|NCT01613248|BG006|Baseline|Total|Total of all reporting groups
11105188|NCT01613248|FG000|Participant Flow|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105189|NCT01613248|FG001|Participant Flow|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105190|NCT01613248|FG002|Participant Flow|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105191|NCT01613248|FG003|Participant Flow|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105192|NCT01613248|FG004|Participant Flow|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105193|NCT01613248|FG005|Participant Flow|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105194|NCT01613248|OG000|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105195|NCT01613248|OG001|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105196|NCT01613248|OG002|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105197|NCT01613248|OG003|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105198|NCT01613248|OG004|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105199|NCT01613248|OG005|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105200|NCT01613248|EG000|Reported Event|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105201|NCT01613248|EG001|Reported Event|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105202|NCT01613248|EG002|Reported Event|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105203|NCT01613248|EG003|Reported Event|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105204|NCT01613248|EG004|Reported Event|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11105205|NCT01613248|EG005|Reported Event|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
11004343|NCT01076270|BG000|Baseline|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
11004344|NCT01076270|FG000|Participant Flow|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
11004345|NCT01076270|OG000|Outcome|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
11004346|NCT01076270|EG000|Reported Event|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
11004347|NCT01076283|BG000|Baseline|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
11004348|NCT01076283|BG001|Baseline|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
11004349|NCT01076283|BG002|Baseline|Total|Total of all reporting groups
11004350|NCT01076283|FG000|Participant Flow|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
11004351|NCT01076283|FG001|Participant Flow|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
11004352|NCT01076283|OG000|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
11004353|NCT01076283|OG001|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
11004354|NCT01076283|EG000|Reported Event|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
11004355|NCT01076283|EG001|Reported Event|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
11004356|NCT01076296|BG000|Baseline|Total for All Groups Assessed|Subjects assessed for LV function using both VScan and a clinical examination.
11004357|NCT01076296|FG000|Participant Flow|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
11004358|NCT01076296|FG001|Participant Flow|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
11004359|NCT01076296|FG002|Participant Flow|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
11004360|NCT01076296|FG003|Participant Flow|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
11004361|NCT01076296|FG004|Participant Flow|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
11004362|NCT01076296|FG005|Participant Flow|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
11004363|NCT01076296|FG006|Participant Flow|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
11004364|NCT01076296|FG007|Participant Flow|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
11004365|NCT01076296|OG000|Outcome|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
11004366|NCT01076296|OG001|Outcome|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
11004367|NCT01076296|OG002|Outcome|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
11004368|NCT01076296|OG003|Outcome|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
11004369|NCT01076296|OG004|Outcome|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension.
11004370|NCT01076296|OG005|Outcome|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension.
11004371|NCT01076296|OG006|Outcome|Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD.
11004372|NCT01076296|OG007|Outcome|No Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD.
11105206|NCT01613313|BG000|Baseline|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105207|NCT01613313|BG001|Baseline|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105208|NCT01613313|BG002|Baseline|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105209|NCT01613313|BG003|Baseline|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105210|NCT01613313|BG004|Baseline|Total|Total of all reporting groups
11105211|NCT01613313|FG000|Participant Flow|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105212|NCT01613313|FG001|Participant Flow|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105213|NCT01613313|FG002|Participant Flow|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105214|NCT01613313|FG003|Participant Flow|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105215|NCT01613313|OG000|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105216|NCT01613313|OG001|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105217|NCT01613313|OG002|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105218|NCT01613313|OG003|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105219|NCT01613313|EG000|Reported Event|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105220|NCT01613313|EG001|Reported Event|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105221|NCT01613313|EG002|Reported Event|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105222|NCT01613313|EG003|Reported Event|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
11105223|NCT01613326|BG000|Baseline|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
11105224|NCT01613326|BG001|Baseline|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
11105225|NCT01613326|BG002|Baseline|Total|Total of all reporting groups
11105226|NCT01613326|FG000|Participant Flow|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
11105227|NCT01613326|FG001|Participant Flow|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
11105228|NCT01613326|OG000|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
11105229|NCT01613326|OG001|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
11105230|NCT01613326|EG000|Reported Event|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
11105231|NCT01613326|EG001|Reported Event|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
11105232|NCT01613339|BG000|Baseline|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
11105233|NCT01613339|BG001|Baseline|Control|No specific treatment.
11105234|NCT01613339|BG002|Baseline|Total|Total of all reporting groups
11105235|NCT01613339|FG000|Participant Flow|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
11105236|NCT01613339|FG001|Participant Flow|Control|No specific treatment.
11105237|NCT01613339|OG000|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
11004373|NCT01076296|EG000|Reported Event|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
11004374|NCT01076296|EG001|Reported Event|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
11004375|NCT01076296|EG002|Reported Event|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
11004376|NCT01076296|EG003|Reported Event|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
11004377|NCT01076296|EG004|Reported Event|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
11004378|NCT01076296|EG005|Reported Event|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
11004379|NCT01076296|EG006|Reported Event|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
11004380|NCT01076296|EG007|Reported Event|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
11004381|NCT01076335|BG000|Baseline|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
11004382|NCT01076335|FG000|Participant Flow|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
11004383|NCT01076335|OG000|Outcome|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
11004384|NCT01076335|EG000|Reported Event|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
11004385|NCT01076348|BG000|Baseline|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
11004386|NCT01076348|FG000|Participant Flow|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
11004387|NCT01076348|OG000|Outcome|Medtronic 4965 Epicardial Lead|Subjects who were implanted with at least 1 model 4965 lead.
11004388|NCT01076348|EG000|Reported Event|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
11004389|NCT01076361|BG000|Baseline|All Enrolled Patients|All patients who were enrolled and implanted with a Model 4968 Lead
11004390|NCT01076361|FG000|Participant Flow|Model 4968 Leads|A total of 631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.
11004391|NCT01076361|OG000|Outcome|Model 4968 Lead Survival Probability|Model 4968 is steroid-eluting bipolar epicardial pacing lead. Participants implanted with Model 4968 lead their data will be obtained for long-term safety and lead events, includes the survival probability for the Model 4968.
11004392|NCT01076361|EG000|Reported Event|Model 4968 Participants|All Model 4968 participants in the analysis cohort
11004393|NCT01076400|BG000|Baseline|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
11004394|NCT01076400|FG000|Participant Flow|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
11004395|NCT01076400|FG001|Participant Flow|Part 2: MK-1775 + Topotecan/Cisplatin|Part 2: MK-1775 capsules will be administered at the dose determined in Part 1 twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1.
11004396|NCT01076400|FG002|Participant Flow|Part 2: Placebo to MK-1775 + Topotecan/Cisplatin|Part 2: Placebo to MK-1775 capsules will be administered twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1.
11004397|NCT01076400|OG000|Outcome|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
11004398|NCT01076400|EG000|Reported Event|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
11105238|NCT01613339|OG001|Outcome|Control|No specific treatment.
11105239|NCT01613339|EG000|Reported Event|Body Awareness Therapy, Control|group training. Controls were asked to continue with their lifestyle.
11105240|NCT01613378|BG000|Baseline|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
11105241|NCT01613378|FG000|Participant Flow|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
11105242|NCT01613378|OG000|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
11105243|NCT01613378|EG000|Reported Event|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
11105244|NCT01613417|BG000|Baseline|ProHance Then Gadovist/Gadavist|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
11105245|NCT01613417|BG001|Baseline|Gadovist/Gadavist Then ProHance|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
11105246|NCT01613417|BG002|Baseline|Total|Total of all reporting groups
11105247|NCT01613417|FG000|Participant Flow|Sequence 1 (ProHance Then Gadovist/Gadavist)|Patients randomized to receive ProHance first
11105248|NCT01613417|FG001|Participant Flow|Sequence 2 (Gadovist/Gadavist Then ProHance)|Patients randomized to receive Gadovist/Gadavist first
11105249|NCT01613417|OG000|Outcome|Reader 1|Paired exams reviewed by Reader 1
11105250|NCT01613417|OG001|Outcome|Reader 2|Paired exams reviewed by Reader 2
11105251|NCT01613417|OG002|Outcome|Reader 3|Paired exams reviewed by Reader 3
11105252|NCT01613417|OG000|Outcome|Reader 1|Lesions reviewed by Reader 1
11105253|NCT01613417|OG001|Outcome|Reader 2|Lesions reviewed by Reader 2
11105254|NCT01613417|OG002|Outcome|Reader 3|Lesions reviewed by Reader 3
11105255|NCT01613417|OG000|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
11105256|NCT01613417|OG001|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
11105257|NCT01613417|OG002|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
11105258|NCT01613417|OG003|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
11105259|NCT01613417|OG004|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
11105260|NCT01613417|OG005|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
11105261|NCT01613417|EG000|Reported Event|Safety Population (ProHance)|All enrolled patients who received a randomized injection of ProHance
11105262|NCT01613417|EG001|Reported Event|Safety Population (Gadovist/Gadavist)|All enrolled patients who received a randomized injection of Gadovist/Gadavist
11105263|NCT01613599|BG000|Baseline|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
11105264|NCT01613599|FG000|Participant Flow|Rituximab|Participants with granulomatosis with polyangiitis (GPA) (Wegener's granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
11105265|NCT01613599|OG000|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
11105266|NCT01613599|EG000|Reported Event|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years
11105267|NCT01613716|BG000|Baseline|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
11105268|NCT01613716|FG000|Participant Flow|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
11105269|NCT01613716|OG000|Outcome|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
11105270|NCT01613716|EG000|Reported Event|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
11105271|NCT01613768|BG000|Baseline|Treatment (Eribulin Mesylate)|Patients receive Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11105272|NCT01613768|FG000|Participant Flow|Treatment (Eribulin Mesylate)|Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11105273|NCT01613768|OG000|Outcome|Treatment (Eribulin Mesylate)|Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11105274|NCT01613768|OG000|Outcome|Treatment (Eribulin Mesylate)|"Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
11105275|NCT01613768|EG000|Reported Event|Treatment (Eribulin Mesylate)|Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11105276|NCT01614093|BG000|Baseline|Oxytocin vs Placebo|Participants rated themselves as significantly less hungry when administered OT (M=36.37, SD=21.0) than placebo (M=44.81, SD=28.6) at 60 min. post-preload, F(5, 15)=8.05, p=0.012.
11105277|NCT01614093|FG000|Participant Flow|Oxytocin/ Placebo|Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
11004399|NCT01076452|BG000|Baseline|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11004400|NCT01076452|BG001|Baseline|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11004401|NCT01076452|BG002|Baseline|Total|Total of all reporting groups
11004402|NCT01076452|FG000|Participant Flow|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11004403|NCT01076452|FG001|Participant Flow|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11004404|NCT01076452|OG000|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11004405|NCT01076452|OG001|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11004406|NCT01076452|EG000|Reported Event|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11004407|NCT01076452|EG001|Reported Event|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11004408|NCT01076504|BG000|Baseline|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
11004409|NCT01076504|FG000|Participant Flow|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
11004410|NCT01076504|OG000|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
11004411|NCT01076504|EG000|Reported Event|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
11004412|NCT01076543|BG000|Baseline|Phase I, All Histologies, Lenalidomide 15 mg|Patients receive lenalidomide 15 mg PO on days 1-21 and25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004413|NCT01076543|BG001|Baseline|Phase I, All Histologies, Lenalidomide 20 mg|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004414|NCT01076543|BG002|Baseline|Phase I, All Histologies, Lenalidomide 25 mg|Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004415|NCT01076543|BG003|Baseline|Phase II, Diffuse Large B-Cell Subtype|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004416|NCT01076543|BG004|Baseline|Phase II, Follicular Subtype|Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004417|NCT01076543|BG005|Baseline|Phase II, Lymphoma NOS|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004418|NCT01076543|BG006|Baseline|Total|Total of all reporting groups
11004419|NCT01076543|FG000|Participant Flow|Phase I, All Histologies, Lenalidomide 15 mg|Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004420|NCT01076543|FG001|Participant Flow|Phase I, All Histologies, Lenalidomide 20 mg|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004421|NCT01076543|FG002|Participant Flow|Phase I, All Histologies, Lenalidomide 25 mg|Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004422|NCT01076543|FG003|Participant Flow|Phase II, Diffuse Large B-Cell Subtype|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004423|NCT01076543|FG004|Participant Flow|Phase II, Follicular Subtype|Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004424|NCT01076543|FG005|Participant Flow|Phase II, Lymphoma NOS|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004425|NCT01076543|OG000|Outcome|Phase I, All Histologies, Lenalidomide 15 mg|Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11105278|NCT01614093|OG000|Outcome|Oxytocin/Placebo|Each participant received intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
11105279|NCT01614093|EG000|Reported Event|Oxytocin|Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
11105280|NCT01614093|EG001|Reported Event|Placebo|Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
11105281|NCT01614210|BG000|Baseline|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
11105282|NCT01614210|FG000|Participant Flow|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
11105283|NCT01614210|OG000|Outcome|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
11105284|NCT01614210|EG000|Reported Event|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
11105285|NCT01614249|BG000|Baseline|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
11105286|NCT01614249|BG001|Baseline|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the intervention group, participants received a dietary supplement of Omega Via fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits to resupply the soft-gels, monitoring of side effects and compliance and data collection.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Each participants took three soft gels of fish oil omega-3 fatty acid per day, each containing more EPA (0.715 grams) than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
11105287|NCT01614249|BG002|Baseline|Total|Total of all reporting groups
11105288|NCT01614249|FG000|Participant Flow|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
11105289|NCT01614249|FG001|Participant Flow|Fish Oil Omega-3 EPA-rich Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
11105290|NCT01614249|OG000|Outcome|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
11105291|NCT01614249|OG001|Outcome|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
11105292|NCT01614249|EG000|Reported Event|Soybean Oil Soft Gels|"Participants on this arm received a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.~Soybean oil soft gels: Each participant received OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
11105293|NCT01614249|EG001|Reported Event|Fish Oil Omega-3 EPA-rich Soft Gels|"Participants received OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.~Fish oil omega-3 EPA-rich soft gels: A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels was taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits."
11105294|NCT01614392|BG000|Baseline|High Velocity Low Force Power Training|Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
11105295|NCT01614392|BG001|Baseline|Low Velocity High Force Power Training|Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
11105296|NCT01614392|BG002|Baseline|Total|Total of all reporting groups
11105297|NCT01614392|FG000|Participant Flow|High Velocity Low Force Power Training|Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
11105298|NCT01614392|FG001|Participant Flow|Low Velocity High Force Power Training|Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
11105299|NCT01614392|OG000|Outcome|Power Training Performed at Low External Resistance|High velocity low force power training performed at low external resistance (40% of the 1repetition maximum strength (RM)[LO]
11105300|NCT01614392|OG001|Outcome|Power Training Performed at High External Resistance|Low velocity high force power training performed at high external resistance (70% of the 1 repetition maximum (RM) [HI])
11105301|NCT01614392|EG000|Reported Event|High Velocity Low Force Power Training|Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
11105302|NCT01614392|EG001|Reported Event|Low Velocity High Force Power Training|Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
11105303|NCT01614457|BG000|Baseline|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
11105304|NCT01614457|BG001|Baseline|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
11105305|NCT01614457|BG002|Baseline|Total|Total of all reporting groups
11105306|NCT01614457|FG000|Participant Flow|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
11105307|NCT01614457|FG001|Participant Flow|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
11105308|NCT01614457|OG000|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
11105309|NCT01614457|OG001|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
11105310|NCT01614457|EG000|Reported Event|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
11105311|NCT01614457|EG001|Reported Event|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
11105312|NCT01614470|BG000|Baseline|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
11105313|NCT01614470|BG001|Baseline|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
11105314|NCT01614470|BG002|Baseline|Total|Total of all reporting groups
11105315|NCT01614470|FG000|Participant Flow|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
11105316|NCT01614470|FG001|Participant Flow|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
11105317|NCT01614470|FG002|Participant Flow|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
11105318|NCT01614470|OG000|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
11105319|NCT01614470|OG001|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
11105320|NCT01614470|OG000|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
11105321|NCT01614470|OG000|Outcome|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
11105322|NCT01614470|EG000|Reported Event|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
11105323|NCT01614470|EG001|Reported Event|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
11105324|NCT01614470|EG002|Reported Event|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
11105325|NCT01614509|BG000|Baseline|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
11105326|NCT01614509|BG001|Baseline|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
11105327|NCT01614509|BG002|Baseline|Total|Total of all reporting groups
11105328|NCT01614509|FG000|Participant Flow|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
11105329|NCT01614509|FG001|Participant Flow|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
11105330|NCT01614509|OG000|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
11105331|NCT01614509|OG001|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
11105332|NCT01614509|EG000|Reported Event|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
11105333|NCT01614509|EG001|Reported Event|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
11105334|NCT01614574|BG000|Baseline|VPRIV® (15-60 U/kg)|Administered as an intravenous (IV) infusion over a 60 minute period.
11105335|NCT01614574|FG000|Participant Flow|VPRIV® (15-60 U/kg)|Administered as an intravenous (IV) infusion over a 60 minute period.
11105336|NCT01614574|OG000|Outcome|VPRIV® (15-60 U/kg)|Administered as an intravenous (IV) infusion over a 60 minute period.
11105337|NCT01614574|EG000|Reported Event|VPRIV® (15-60 U/kg)|Administered as an intravenous (IV) infusion over a 60 minute period.
11105338|NCT01614600|BG000|Baseline|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
11105339|NCT01614600|FG000|Participant Flow|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
11105340|NCT01614600|OG000|Outcome|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
11105341|NCT01614600|EG000|Reported Event|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
11105342|NCT01614613|BG000|Baseline|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
11105343|NCT01614613|FG000|Participant Flow|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal:safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips.
11105344|NCT01614613|OG000|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
11105345|NCT01614613|OG000|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
11105346|NCT01614613|EG000|Reported Event|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. Subgroup 1 goal:safely decrease subject glucose levels during the visit. Subgroup 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
11105347|NCT01614743|BG000|Baseline|Group 1 - IncobotulinumtoxinA|Experimental injection given at baseline and Week 16
11105348|NCT01614743|BG001|Baseline|Group 2 - Bacteriostatic Saline|Placebo at baseline, incobotulinumtoxinA at 16 weeks
11105349|NCT01614743|BG002|Baseline|Total|Total of all reporting groups
11105350|NCT01614743|FG000|Participant Flow|IncobotulinumtoxinA at Baseline and Week 16|IncobotulinumtoxinA: Experimental injection given at baseline and Week 16
11105351|NCT01614743|FG001|Participant Flow|Placebo at Baseline, Then incobotulinumtoxinA at 16 Weeks|Bacteriostatic saline: Placebo at baseline, incobotulinumtoxinA at 16 weeks
11105352|NCT01614743|OG000|Outcome|Group 1 - IncobotulinumtoxinA|IncobotulinumtoxinA: Experimental injection given at baseline and Week 16
11105353|NCT01614743|OG001|Outcome|Group 2 - Bacteriostatic Saline|Bacteriostatic saline: Placebo at baseline, incobotulinumtoxinA at 16 weeks
11105354|NCT01614743|EG000|Reported Event|Group 1 - IncobotulinumtoxinA|Experimental injection given at baseline and Week 16
11105355|NCT01614743|EG001|Reported Event|Group 2 - Bacteriostatic Saline|Placebo at baseline, incobotulinumtoxinA at 16 weeks
11105356|NCT01614769|BG000|Baseline|All Participants|All randomized participants
11105357|NCT01614769|FG000|Participant Flow|Placebo → Glimepiride 2 mg → Glimepiride 4 mg|Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
11105358|NCT01614769|FG001|Participant Flow|Glimepiride 2 mg → Glimepiride 4 mg → Placebo|Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
11105359|NCT01614769|FG002|Participant Flow|Glimepiride 4 mg → Placebo → Glimepiride 2 mg|Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
11105360|NCT01614769|FG003|Participant Flow|Placebo → Glimepiride 4 mg → Glimepiride 2 mg|Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
11105361|NCT01614769|FG004|Participant Flow|Glimepiride 2 mg → Placebo → Glimepiride 4 mg|Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
11105362|NCT01614769|FG005|Participant Flow|Glimepiride 4 mg → Glimepiride 2 mg → Placebo|Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
11105363|NCT01614769|OG000|Outcome|Placebo|Participants received placebo in a treatment period.
11105364|NCT01614769|OG001|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
11105365|NCT01614769|OG002|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
11105366|NCT01614769|EG000|Reported Event|Placebo|Participants received placebo in a treatment period.
11105367|NCT01614769|EG001|Reported Event|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
11105368|NCT01614769|EG002|Reported Event|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
11105369|NCT01614795|BG000|Baseline|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105370|NCT01614795|BG001|Baseline|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105371|NCT01614795|BG002|Baseline|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11224513|NCT02360475|OG001|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
10846750|NCT00279708|OG000|Outcome|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
11105372|NCT01614795|BG003|Baseline|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105373|NCT01614795|BG004|Baseline|Total|Total of all reporting groups
11105374|NCT01614795|FG000|Participant Flow|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105375|NCT01614795|FG001|Participant Flow|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105376|NCT01614795|FG002|Participant Flow|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105377|NCT01614795|FG003|Participant Flow|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105378|NCT01614795|OG000|Outcome|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105379|NCT01614795|OG001|Outcome|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105380|NCT01614795|OG002|Outcome|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105381|NCT01614795|OG003|Outcome|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105382|NCT01614795|OG000|Outcome|Treatment (Cixutumumab, Temsirolimus)|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~Cixutumumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV"
11105383|NCT01614795|EG000|Reported Event|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105384|NCT01614795|EG001|Reported Event|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105385|NCT01614795|EG002|Reported Event|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105386|NCT01614795|EG003|Reported Event|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
11105387|NCT01614821|BG000|Baseline|Treatment Arm|"PCI-32765; ibrutinib~PCI-32765: Taken orally, once daily in the morning"
11105388|NCT01614821|FG000|Participant Flow|Treatment Arm|"PCI-32765; ibrutinib~PCI-32765: Taken orally, once daily in the morning"
11105389|NCT01614821|OG000|Outcome|Treatment Arm|"PCI-32765; ibrutinib~PCI-32765: Taken orally, once daily in the morning"
11105390|NCT01614821|EG000|Reported Event|Treatment Arm|"PCI-32765; ibrutinib~PCI-32765: Taken orally, once daily in the morning"
11105391|NCT01614847|BG000|Baseline|Arm 1. Isotonic Hyaluronate Artificial Tear FIRST|Per sequence. Four subject, chosen at random, will receive isotonic hyaluronate artificial tear in Session 1. After a 24-hour washout period, they will return for Session 2, when they will receive saline eye drops.
11105392|NCT01614847|BG001|Baseline|Arm 2. Normal Saline FIRST|Per sequence. The four remaining subject (see comments to left), will receive saline eye drops in Session 1. After a 24-hour washout period, they will return for Session 2, when they will receive isotonic hyaluronate artificial tears.
11105393|NCT01614847|BG002|Baseline|Total|Total of all reporting groups
11105394|NCT01614847|FG000|Participant Flow|Group 1: Four Subjects Who Received Drop A on Day 1|All eight subject received Drop A (hyaluronate) on one day and Drop B (saline) on the other day. Subjects #1, 2, 3, 4 received Drop A on Day 1 and Drop B on Day 2.
11105395|NCT01614847|FG001|Participant Flow|Group 2: Four Subjects Who Received Drop B on Day 1|All eight subject received Drop A (hyaluronate) on one day and Drop B (saline) on the other day. Subjects #5, 6, 7, 8 received Drop B on Day 1 and Drop A on Day 2.
11105396|NCT01614847|OG000|Outcome|5 Minutes|Mean* change in tear osmolarity (mOsmol/L) from baseline 5 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (*Mean of change values measured for right and left eyes.)
11105397|NCT01614847|OG001|Outcome|20 Minutes|Mean* change in tear osmolarity (mOsmol/L) from baseline 20 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (*Mean of change values measured for right and left eyes.)
11105398|NCT01614847|OG002|Outcome|35 Minutes|Mean* change in tear osmolarity (mOsmol/L) from baseline 35 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (*Mean of change values measured for right and left eyes.)
11105399|NCT01614847|OG003|Outcome|50 Minutes|Mean* change in tear osmolarity (mOsmol/L) from baseline 50 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (*Mean of change values measured for right and left eyes.)
11105400|NCT01614847|OG004|Outcome|65 Minutes|Mean* change in tear osmolarity (mOsmol/L) from baseline 65 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (*Mean of change values measured for right and left eyes.)
11105401|NCT01614847|OG005|Outcome|80 Minutes|Mean* change in tear osmolarity (mOsmol/L) from baseline 80 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (*Mean of change values measured for right and left eyes.)
11105402|NCT01614847|OG006|Outcome|95 Minutes|Mean* change in tear osmolarity (mOsmol/L) from baseline 95 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (*Mean of change values measured for right and left eyes.)
11105403|NCT01614847|EG000|Reported Event|Isotonic Hyaluronate Artificial Tear|At random, subjects will receive isotonic hyaluraonate artificial tear or a control (normal saline).
11105404|NCT01614847|EG001|Reported Event|Normal Saline|Subject not assigned to Arm1 (experimental group) were assigned to this group during Session 1. Twenty-four hours later subjects were assigned to the alternate groups (cross-over).
11105405|NCT01614886|BG000|Baseline|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
11105406|NCT01614886|BG001|Baseline|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
11105407|NCT01614886|BG002|Baseline|Total|Total of all reporting groups
11105408|NCT01614886|FG000|Participant Flow|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
11105409|NCT01614886|FG001|Participant Flow|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
11105410|NCT01614886|OG000|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
11105411|NCT01614886|OG001|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
11105412|NCT01614886|EG000|Reported Event|Rivastigmine Patch 1-step|Rivastigmine patch 1-step
11105413|NCT01614886|EG001|Reported Event|Rivastigmine Patch 3-step|Rivastigmine patch 3-step
11105414|NCT01614925|BG000|Baseline|Emdogain|"Periodontal surgery with the additional use of Straumann® Emdogain~Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain"
11105415|NCT01614925|BG001|Baseline|Periodontal Surgery|"Periodontal surgery alone~Periodontal surgery: Periodontal surgery alone"
11105416|NCT01614925|BG002|Baseline|Total|Total of all reporting groups
11105417|NCT01614925|FG000|Participant Flow|Emdogain|"Periodontal surgery with the additional use of Straumann® Emdogain~Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain"
11105418|NCT01614925|FG001|Participant Flow|Periodontal Surgery|"Periodontal surgery alone~Periodontal surgery: Periodontal surgery alone"
11105419|NCT01614925|OG000|Outcome|Emdogain|"Periodontal surgery with the additional use of Straumann® Emdogain~Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain"
11105420|NCT01614925|OG001|Outcome|Periodontal Surgery|"Periodontal surgery alone~Periodontal surgery: Periodontal surgery alone"
11105421|NCT01614925|EG000|Reported Event|Emdogain|"Periodontal surgery with the additional use of Straumann® Emdogain~Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain"
11105422|NCT01614925|EG001|Reported Event|Periodontal Surgery|"Periodontal surgery alone~Periodontal surgery: Periodontal surgery alone"
11105423|NCT01615120|BG000|Baseline|GTx-758 125mg|"one GTx-758 tablet orally administered daily~GTx-758 125 mg: One 125 mg tablet once a day"
11105424|NCT01615120|BG001|Baseline|GTx-758 250 mg|"two GTx-758 tablets orally administered daily~GTx-758 250 mg: two 125 mg tablets once daily"
11105425|NCT01615120|BG002|Baseline|Total|Total of all reporting groups
11105426|NCT01615120|FG000|Participant Flow|GTx-758 125mg|"one GTx-758 tablet orally administered daily~GTx-758 125 mg: One 125 mg tablet once a day"
11105427|NCT01615120|FG001|Participant Flow|GTx-758 250 mg|"two GTx-758 tablets orally administered daily~GTx-758 250 mg: two 125 mg tablets once daily"
11105428|NCT01615120|OG000|Outcome|GTx-758 125mg|"one GTx-758 tablet orally administered daily~GTx-758 125 mg: One 125 mg tablet once a day"
11105429|NCT01615120|OG001|Outcome|GTx-758 250 mg|"two GTx-758 tablets orally administered daily~GTx-758 250 mg: two 125 mg tablets once daily"
11105430|NCT01615120|EG000|Reported Event|GTx-758 125mg|"one GTx-758 tablet orally administered daily~GTx-758 125 mg: One 125 mg tablet once a day"
11105431|NCT01615120|EG001|Reported Event|GTx-758 250 mg|"two GTx-758 tablets orally administered daily~GTx-758 250 mg: two 125 mg tablets once daily"
11105432|NCT01615198|BG000|Baseline|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
11105433|NCT01615198|BG001|Baseline|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
11105434|NCT01615198|BG002|Baseline|Total|Total of all reporting groups
11105435|NCT01615198|FG000|Participant Flow|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
11105436|NCT01615198|FG001|Participant Flow|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
11105437|NCT01615198|OG000|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
11105438|NCT01615198|OG001|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
11105439|NCT01615198|EG000|Reported Event|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
11105440|NCT01615198|EG001|Reported Event|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
11105441|NCT01615263|BG000|Baseline|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
11105442|NCT01615263|BG001|Baseline|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
11105443|NCT01615263|BG002|Baseline|Total|Total of all reporting groups
11105444|NCT01615263|FG000|Participant Flow|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
11105445|NCT01615263|FG001|Participant Flow|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
11105446|NCT01615263|OG000|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
11105447|NCT01615263|OG001|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
11105448|NCT01615263|EG000|Reported Event|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
11105449|NCT01615263|EG001|Reported Event|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9F, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
11105450|NCT01615328|BG000|Baseline|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
11105451|NCT01615328|BG001|Baseline|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
11105452|NCT01615328|BG002|Baseline|Total|Total of all reporting groups
11105453|NCT01615328|FG000|Participant Flow|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
11105454|NCT01615328|FG001|Participant Flow|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
11105455|NCT01615328|OG000|Outcome|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
11105456|NCT01615328|OG001|Outcome|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
11105457|NCT01615328|OG000|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.~Cervios ChronOs: The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure."
11105458|NCT01615328|OG001|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.~Bonion: The ACDF surgery will be carried out with Bonion after randomization procedure."
11105459|NCT01615328|OG000|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.~Cervios ChronOs: The ACDF surgery will be caried out with Cervios ChronOs after randomization procedure."
11105460|NCT01615328|OG001|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.~Bonion: The ACDF surgery will be caried out with Bonion after randomization procedure."
11105461|NCT01615328|EG000|Reported Event|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
11105462|NCT01615328|EG001|Reported Event|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
11105463|NCT01615367|BG000|Baseline|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
11105464|NCT01615367|BG001|Baseline|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
11105465|NCT01615367|BG002|Baseline|Total|Total of all reporting groups
11105466|NCT01615367|FG000|Participant Flow|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
11105467|NCT01615367|FG001|Participant Flow|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.~Participants randomized to TAU who complete the first 20 weeks of the study will have the option to receive NEW Tx. TAU participants who chose to receive NEW Tx (the waitlist group) will follow the same procedures as the NEW Tx group over an additional 20 weeks. Assessment data was collected but not analyzed."
11105468|NCT01615367|OG000|Outcome|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
11105469|NCT01615367|OG001|Outcome|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
11105470|NCT01615367|EG000|Reported Event|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
11105471|NCT01615367|EG001|Reported Event|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
11105472|NCT01615484|BG000|Baseline|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
11105473|NCT01615484|BG001|Baseline|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
11105474|NCT01615484|BG002|Baseline|Total|Total of all reporting groups
11105475|NCT01615484|FG000|Participant Flow|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
11105476|NCT01615484|FG001|Participant Flow|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
11105477|NCT01615484|OG000|Outcome|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
11105478|NCT01615484|OG001|Outcome|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
11105479|NCT01615484|EG000|Reported Event|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
11105480|NCT01615484|EG001|Reported Event|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
11105481|NCT01615731|BG000|Baseline|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
11105482|NCT01615731|BG001|Baseline|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
11105483|NCT01615731|BG002|Baseline|Total|Total of all reporting groups
11105484|NCT01615731|FG000|Participant Flow|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
11105485|NCT01615731|FG001|Participant Flow|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
11105486|NCT01615731|OG000|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
11105487|NCT01615731|OG001|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
11105488|NCT01615731|EG000|Reported Event|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
11105489|NCT01615731|EG001|Reported Event|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
11105490|NCT01615809|BG000|Baseline|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization was 10 ml (50 mg) twice a week for the first week, and then from the second week onwards was reduced to 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count demonstrated to be greater than or equal to 1500 cells/mm3."
11105491|NCT01615809|FG000|Participant Flow|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
11105492|NCT01615809|OG000|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
11105493|NCT01615809|EG000|Reported Event|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
11105494|NCT01615822|BG000|Baseline|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
11348278|NCT04194008|EG000|Reported Event|Nerivio Device Treatment|"Treatment with active Nerivio device~Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
11348279|NCT04191668|BG000|Baseline|PSG and NightOwl|"Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.~NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device"
11348280|NCT04191668|FG000|Participant Flow|PSG and NightOwl|"Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.~NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device"
11348281|NCT04191668|OG000|Outcome|PSG and NightOwl|"Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.~NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device"
11105495|NCT01615822|BG001|Baseline|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
11105496|NCT01615822|BG002|Baseline|Placebo|Placebo
11105497|NCT01615822|BG003|Baseline|Total|Total of all reporting groups
11105498|NCT01615822|FG000|Participant Flow|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
11105499|NCT01615822|FG001|Participant Flow|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
11105500|NCT01615822|FG002|Participant Flow|Placebo|Placebo
11105501|NCT01615822|OG000|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension~OZ439 100mg: OZ439 100mg oral suspension, single dose"
11105502|NCT01615822|OG001|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet~OZ439 100mg: OZ439 100mg oral suspension, single dose~MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
11105503|NCT01615822|OG002|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension~OZ439 400mg: OZ439 400mg oral suspension, single dose"
11105504|NCT01615822|OG003|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets~OZ439 400mg: OZ439 400mg oral suspension, single dose~MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
11105505|NCT01615822|OG000|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
11105506|NCT01615822|OG001|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
11105507|NCT01615822|EG000|Reported Event|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
11105508|NCT01615822|EG001|Reported Event|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
11348282|NCT04191668|EG000|Reported Event|PSG and NightOwl|"Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.~NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device"
11348283|NCT04189081|BG000|Baseline|Water Control|"Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~Water Control: negative control"
11105509|NCT01615822|EG002|Reported Event|Placebo|Placebo
11105510|NCT01615939|BG000|Baseline|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
11105511|NCT01615939|BG001|Baseline|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
11105512|NCT01615939|BG002|Baseline|Total|Total of all reporting groups
11105513|NCT01615939|FG000|Participant Flow|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
11105514|NCT01615939|FG001|Participant Flow|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
11105515|NCT01615939|OG000|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
11105516|NCT01615939|OG001|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
11105517|NCT01615939|EG000|Reported Event|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
11105518|NCT01615939|EG001|Reported Event|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
11105519|NCT01616056|BG000|Baseline|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
11105520|NCT01616056|FG000|Participant Flow|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
11105521|NCT01616056|OG000|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
11105522|NCT01616056|EG000|Reported Event|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
11126575|NCT01734382|BG002|Baseline|Part 2: TCZ IV 8 mg/kg Q3W/Q4W|Participants with weight >/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.
11126576|NCT01734382|BG003|Baseline|Total|Total of all reporting groups
11126577|NCT01734382|FG000|Participant Flow|Part 1: Tocilizumab (TCZ) Q2W|Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants < 30 kg; 8 mg/kg for participants >/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study.
11126578|NCT01734382|FG001|Participant Flow|Part 2: TCZ IV 12 mg/kg Q3W/Q4W|Participants with weight < 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.
11126579|NCT01734382|FG002|Participant Flow|Part 2: TCZ IV 8 mg/kg Q3W/Q4W|Participants with weight >/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.
11105523|NCT01616082|BG000|Baseline|Ovweight/Obese With no Drug|"After screening, overweight (obese subjects (BMI >27 - ≤40.0) subjects (n=35) will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.~Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks."
11105524|NCT01616082|BG001|Baseline|Overweigh/Obese With Phentermine|"After screening, obese subjects (BMI >27- ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.~Low Calorie Diet (LCD): See prior information.~Phentermine: See prior information.~Protection Against Risk: See prior information.~."
11105525|NCT01616082|BG002|Baseline|Total|Total of all reporting groups
11105526|NCT01616082|FG000|Participant Flow|Overweight/Obese With no Drug|"After screening, overweight (obese subjects (BMI<27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.~Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. LCD period= continuous for 8 weeks."
11105527|NCT01616082|FG001|Participant Flow|Overweight/Obese With Phentermine|"After screening, overweight/obese (BMI 27.0-≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.~Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. LCD period = continuous for 8 weeks.~Phentermine: Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD."
11105528|NCT01616082|OG000|Outcome|Overweight/Obese With no Drug|"After screening, overweight (obese subjects (BMI >27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.~Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks."
11105529|NCT01616082|OG001|Outcome|Overweight/ Obese With Phentermine|"After screening, obese subjects (BMI >27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.~Low Calorie Diet (LCD): See prior information.~Phentermine: See prior information.~Protection Against Risk: See prior information.~."
11105530|NCT01616082|OG000|Outcome|Overweight/ Obese With no Drug|"After screening, overweight (obese subjects (BMI >27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.~Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks."
11105531|NCT01616082|EG000|Reported Event|Overweight/Obese With no Drug|"After screening, overweight (obese subjects (BMI >27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.~Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks."
11105532|NCT01616082|EG001|Reported Event|Overwight/Obese With Phentermine|"After screening, obese subjects (BMI >27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.~Low Calorie Diet (LCD)~Phentermine"
11105533|NCT01616160|BG000|Baseline|Nasal Polyps Subjects|"Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.~mometasone furoate: 2 sprays/nostril BID"
11105534|NCT01616160|FG000|Participant Flow|Nasal Polyps Subjects|"Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.~mometasone furoate: 2 sprays/nostril BID"
11105535|NCT01616160|OG000|Outcome|Nasal Polyps Subjects|"Intervention: Each subject received Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.~mometasone furoate: 2 sprays/nostril twice daily"
11105536|NCT01616160|EG000|Reported Event|Nasal Polyps Subjects|"Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.~mometasone furoate: 2 sprays/nostril BID"
11105537|NCT01616173|BG000|Baseline|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
11105538|NCT01616173|BG001|Baseline|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
11105539|NCT01616173|BG002|Baseline|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
11105540|NCT01616173|BG003|Baseline|Total|Total of all reporting groups
11105541|NCT01616173|FG000|Participant Flow|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
11105542|NCT01616173|FG001|Participant Flow|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
11105543|NCT01616173|FG002|Participant Flow|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
11105544|NCT01616173|OG000|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
11105545|NCT01616173|OG001|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
11105546|NCT01616173|OG002|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
11105547|NCT01616173|EG000|Reported Event|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
11105548|NCT01616173|EG001|Reported Event|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
11105549|NCT01616173|EG002|Reported Event|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
11105550|NCT01616459|BG000|Baseline|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105551|NCT01616459|BG001|Baseline|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105552|NCT01616459|BG002|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105553|NCT01616459|BG003|Baseline|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
11105554|NCT01616459|BG004|Baseline|Total|Total of all reporting groups
11105555|NCT01616459|FG000|Participant Flow|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105556|NCT01616459|FG001|Participant Flow|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
10846751|NCT00279708|OG001|Outcome|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study: Placebo vs. Atorvastatin
11105557|NCT01616459|FG002|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105558|NCT01616459|FG003|Participant Flow|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105559|NCT01616459|OG000|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105560|NCT01616459|OG001|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105561|NCT01616459|OG002|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105562|NCT01616459|OG003|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
11105563|NCT01616459|OG001|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105564|NCT01616459|OG001|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
10846752|NCT00279708|EG000|Reported Event|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
11105565|NCT01616459|OG000|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105566|NCT01616459|OG003|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105567|NCT01616459|OG003|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105568|NCT01616459|EG000|Reported Event|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105569|NCT01616459|EG001|Reported Event|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105570|NCT01616459|EG002|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
11105571|NCT01616459|EG003|Reported Event|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
11105572|NCT01616563|BG000|Baseline|Diet and Exercise Intervention|A combined diet and exercise program tailored to individuals incorporating behavioural modification support
11105573|NCT01616563|FG000|Participant Flow|Diet and Exercise Intervention|A combined diet and exercise program tailored to individuals incorporating behavioural modification support
11105574|NCT01616563|OG000|Outcome|Diet and Exercise Intervention|A combined diet and exercise program tailored to individuals incorporating behavioural modification support
11105575|NCT01616563|OG000|Outcome|Diet and Exercise Intervention|A combined diet and exercise program tailored to individuals incorporating behavioural modification support.
10846753|NCT00279708|EG001|Reported Event|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
11126580|NCT01734382|OG000|Outcome|Part 2: TCZ IV 12 mg/kg Q3W|Participants received tocilizumab 12 mg/kg IV infusions Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria.
11105576|NCT01616563|EG000|Reported Event|Diet and Exercise Intervention|"A combined diet and exercise program tailored to individuals incorporating behavioural modification support~Dietary Intervention: Nutrition assessment, review of the basic principles of dietary intervention for metabolic syndrome with an emphasis on the clinical risk factors identified for each individual, joint goal setting to determine what dietary changes are feasible, considering intention and barriers to dietary behaviour change.~Exercise Prescription and Fitness Program: Exercise tests (aerobic fitness, muscular and flexibility tests) recommended by the Canadian Society of Exercise Physiology (CSEP), followed by an individualized exercise plan including fitness assessments."
11105577|NCT01616576|BG000|Baseline|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
11105578|NCT01616576|BG001|Baseline|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
11105579|NCT01616576|BG002|Baseline|Total|Total of all reporting groups
11105580|NCT01616576|FG000|Participant Flow|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
11105581|NCT01616576|FG001|Participant Flow|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
11105582|NCT01616576|OG000|Outcome|Group A and Group B Data Pooled|Data from Group A (n=18) and Group B (n=18) were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B; Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B. The resulting mean Control score was subtracted from the mean Experimental score to yield a paired difference score (i.e. Experimental - Control = paired difference score). The paired difference score (n=36) is reported below for each listening condition.
11105583|NCT01616576|OG001|Outcome|Control|Data from Group A and Group B were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B.
11105584|NCT01616576|OG002|Outcome|Experimental|Data from Group A and Group B were pooled for the statistical analyses. Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B.
11105585|NCT01616576|OG000|Outcome|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
11105586|NCT01616576|OG001|Outcome|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
11105587|NCT01616576|EG000|Reported Event|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition for the second week.~Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
11105588|NCT01616576|EG001|Reported Event|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
11105589|NCT01616654|BG000|Baseline|CD5789 25 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
11105590|NCT01616654|BG001|Baseline|CD5789 50 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
11105591|NCT01616654|BG002|Baseline|CD5789 100 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
11105592|NCT01616654|BG003|Baseline|Tazarotene 0.1% Gel|Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
11105593|NCT01616654|BG004|Baseline|Vehicle Cream|Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
10846754|NCT00279812|BG000|Baseline|Placebo|"Placebo~Selenomethionine (supplement) and selenium enriched onions"
11105594|NCT01616654|BG005|Baseline|Total|Total of all reporting groups
11105595|NCT01616654|FG000|Participant Flow|CD5789 25 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
11105596|NCT01616654|FG001|Participant Flow|CD5789 50 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
11105597|NCT01616654|FG002|Participant Flow|CD5789 100 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
11105598|NCT01616654|FG003|Participant Flow|Tazarotene 0.1% Gel|Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
11105599|NCT01616654|FG004|Participant Flow|Vehicle Cream|Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
11105600|NCT01616654|OG000|Outcome|CD5789 25 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
11105601|NCT01616654|OG001|Outcome|CD5789 50 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
11105602|NCT01616654|OG002|Outcome|CD5789 100 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
11105603|NCT01616654|OG003|Outcome|Tazarotene 0.1% Gel|Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
11105604|NCT01616654|OG004|Outcome|CD5789 Vehicle Cream|Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
11105605|NCT01616654|OG004|Outcome|Vehicle Cream|Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
11105606|NCT01616654|EG000|Reported Event|CD5789 25 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
11105607|NCT01616654|EG001|Reported Event|CD5789 50 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
11105608|NCT01616654|EG002|Reported Event|CD5789 100 mcg/g Cream|Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
11105609|NCT01616654|EG003|Reported Event|Tazarotene 0.1% Gel|Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
11105610|NCT01616654|EG004|Reported Event|CD5789 Vehicle Cream|Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
11105611|NCT01616693|BG000|Baseline|Zinc and Probiotic|"Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.~Probiotic: A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.~Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105612|NCT01616693|BG001|Baseline|Zinc Alone|"Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.~Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105613|NCT01616693|BG002|Baseline|Probiotic Alone|"Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Probiotic: A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.~Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105614|NCT01616693|BG003|Baseline|Placebo|"Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.~Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105615|NCT01616693|BG004|Baseline|Total|Total of all reporting groups
11105616|NCT01616693|FG000|Participant Flow|Zinc and Probiotic|"Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.~Probiotic: A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.~Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11126581|NCT01734382|OG001|Outcome|Part 2: TCZ IV 8 mg/kg Q3W|Participants received tocilizumab 8 mg/kg IV infusions Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria.
11126582|NCT01734382|OG002|Outcome|Part 2: TCZ IV 12 mg/kg Q4W|Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg Q4W up to Week 52 in Part 2 of the study.
11105617|NCT01616693|FG001|Participant Flow|Zinc Alone|"Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.~Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105618|NCT01616693|FG002|Participant Flow|Probiotic Alone|"Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Probiotic: A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.~Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105619|NCT01616693|FG003|Participant Flow|Placebo|"Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.~Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105620|NCT01616693|OG000|Outcome|Zinc and Probiotic|"Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.~Probiotic: A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.~Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105621|NCT01616693|OG001|Outcome|Zinc Alone|"Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.~Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105622|NCT01616693|OG002|Outcome|Probiotic Alone|"Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Probiotic: A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.~Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105623|NCT01616693|OG003|Outcome|Placebo|"Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.~Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105624|NCT01616693|OG004|Outcome|Zinc|All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)
11105625|NCT01616693|OG005|Outcome|No Zinc|All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)
11105626|NCT01616693|OG006|Outcome|Probiotic|All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)
11105627|NCT01616693|OG007|Outcome|No Probiotic|All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)
11105628|NCT01616693|EG000|Reported Event|Zinc and Probiotic|"Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.~Probiotic: A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.~Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105629|NCT01616693|EG001|Reported Event|Zinc Alone|"Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Zinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.~Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105630|NCT01616693|EG002|Reported Event|Probiotic Alone|"Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Probiotic: A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.~Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105631|NCT01616693|EG003|Reported Event|Placebo|"Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.~Probiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.~Zinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.~Rotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.~Oral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks."
11105632|NCT01616771|BG000|Baseline|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
11105633|NCT01616771|FG000|Participant Flow|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
11105634|NCT01616771|OG000|Outcome|Macintosh Laryngoscope|After induction of anesthesia, Macintosh laryngoscope was inserted into mouth and C&L grade was checked.
11105635|NCT01616771|OG001|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
11105636|NCT01616771|OG000|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
11105637|NCT01616771|OG001|Outcome|Smaller Sized GVL|The C&L grade was reassessed by smaller sized GVL, after removal of GVL selected by weight
11105638|NCT01616771|EG000|Reported Event|Macintosh Laryngoscope|C&L grade assessment by Macintosh laryngoscope, after induction of anesthesia
11105639|NCT01616771|EG001|Reported Event|GVL Selected by Weight|C&L grade assessment by GVL selected by weight, after removal of Macintosh laryngoscope
11105640|NCT01616771|EG002|Reported Event|Smaller Sized GVL|C&L grade assessment by smaller sized GVL, after removal of GVL selected by weight
10846755|NCT00279812|BG001|Baseline|50ug Selenium Enriched Yeast|Selenomethionine supplement (50ug/d Se) for 12 weeks
10846756|NCT00279812|BG002|Baseline|100ug Selenium Enriched Yeast|Selenomethionine supplement (100ug/d Se) for 12 weeks
11105641|NCT01616953|BG000|Baseline|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
11105642|NCT01616953|BG001|Baseline|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
11105643|NCT01616953|BG002|Baseline|Total|Total of all reporting groups
11105644|NCT01616953|FG000|Participant Flow|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
11105645|NCT01616953|FG001|Participant Flow|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
11105646|NCT01616953|OG000|Outcome|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
11126583|NCT01734382|OG003|Outcome|Part 2: TCZ IV 8 mg/kg Q4W|Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.
10846757|NCT00279812|BG003|Baseline|200ug Selenium Enriched Yeast|Selenomethionine supplement (200ug/d Se) for 12 weeks
11105647|NCT01616953|OG001|Outcome|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
11105648|NCT01616953|EG000|Reported Event|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
11105649|NCT01616953|EG001|Reported Event|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
11105650|NCT01617005|BG000|Baseline|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
11105651|NCT01617005|FG000|Participant Flow|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
11105652|NCT01617005|OG000|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
11105653|NCT01617005|EG000|Reported Event|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
11105654|NCT01617070|BG000|Baseline|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan~One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)~Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
11105655|NCT01617070|FG000|Participant Flow|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan~One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)~Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
11105656|NCT01617070|OG000|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
11105657|NCT01617070|OG001|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
11105658|NCT01617070|OG002|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
11105659|NCT01617070|OG003|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
11105660|NCT01617070|EG000|Reported Event|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
10846758|NCT00279812|BG004|Baseline|Control Onion|3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
10846759|NCT00279812|BG005|Baseline|Enriched Onion|3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
11105661|NCT01617070|EG001|Reported Event|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
11105662|NCT01617070|EG002|Reported Event|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
11105663|NCT01617070|EG003|Reported Event|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
11105664|NCT01617083|BG000|Baseline|Azithromycin|"Antibiotic used to treat infections.~Azithromycin: Antibiotic used to treat infections"
11105665|NCT01617083|BG001|Baseline|Placebo|"Compound thickening agent with sugar and flavor additives.~Placebo: Thickening compound with sugar and flavoring"
11105666|NCT01617083|BG002|Baseline|Not Randomized|Participants only completed the baseline assessments but did not receive treatment.
11105667|NCT01617083|BG003|Baseline|Total|Total of all reporting groups
11105668|NCT01617083|FG000|Participant Flow|Azithromycin|"Antibiotic used to treat infections.~Azithromycin: Antibiotic used to treat infections"
11105669|NCT01617083|FG001|Participant Flow|Placebo|"Compound thickening agent with sugar and flavor additives.~Placebo: Thickening compound with sugar and flavoring"
11105670|NCT01617083|FG002|Participant Flow|Not Randomized|Participants consented to participate in the study. They completed baseline assessments but did not randomize to treatment.
11105671|NCT01617083|OG000|Outcome|Azithromycin|"Antibiotic used to treat infections.~Azithromycin: Antibiotic used to treat infections"
11105672|NCT01617083|OG001|Outcome|Placebo|"Compound thickening agent with sugar and flavor additives.~Placebo: Thickening compound with sugar and flavoring"
11105673|NCT01617083|OG002|Outcome|Not Randomized|Participants consented to participate in the study. They completed baseline assessments but did not randomize to treatment.
11105674|NCT01617083|EG000|Reported Event|Azithromycin|This group was assigned to receive azithromycin (antibiotic).
11105675|NCT01617083|EG001|Reported Event|Placebo|This group was assigned to receive placebo (compound thickening agent with sugar and flavor additives - not active treatment).
11105676|NCT01617148|BG000|Baseline|Single Group|Subjects were included in the study if they met the following criteria: (1) active subfoveal choroidal neovascularization secondary to exudative AMD confirmed by fluorescein angiography (2) E-ETDRS vision of 25 to 80 letters (Snellen equivalent of ~20/25 to 20/320) (3) at least one prior injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab (Avastin and Lucentis, respectively; Genentech Inc, South San Francisco, CA, USA) within 3 months of enrollment, and (4) had an initial response on optical coherence tomography (OCT) defined as a decrease of retinal edema and/or subretinal fluid to anti-VEGF injections followed by recurrent increase in fluid on OCT (further defined as intraretinal, cystoid, subretinal fluid, or worsening pigment epithelial detachment) or the presence of a new hemorrhage on clinical examination.
11105677|NCT01617148|FG000|Participant Flow|Single Group|Subjects were included in the study if they met the following criteria: (1) active subfoveal choroidal neovascularization secondary to exudative Age-related Macular Degeneration (AMD) confirmed by fluorescein angiography (2) E-ETDRS vision of 25 to 80 letters (Snellen equivalent of ~20/25 to 20/320) (3) at least one prior injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab (Avastin and Lucentis, respectively; Genentech Inc, South San Francisco, California, USA) within 3 months of enrollment, and (4) had an initial response on optical coherence tomography (OCT) defined as a decrease of retinal edema and/or subretinal fluid to anti-Vascular Endothelial Growth Factor (anti-VEGF) injections followed by recurrent increase in fluid on OCT (further defined as intraretinal, cystoid, subretinal fluid, or worsening pigment epithelial detachment) or the presence of a new hemorrhage on clinical examination.
11105678|NCT01617148|OG000|Outcome|Single Group|Subjects were included in the study if they met the following criteria: (1) active subfoveal choroidal neovascularization secondary to exudative AMD confirmed by fluorescein angiography (2) E-ETDRS vision of 25 to 80 letters (Snellen equivalent of ~20/25 to 20/320) (3) at least one prior injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab (Avastin and Lucentis, respectively; Genentech Inc, South San Francisco, CA, USA) within 3 months of enrollment, and (4) had an initial response on optical coherence tomography (OCT) defined as a decrease of retinal edema and/or subretinal fluid to anti-VEGF injections followed by recurrent increase in fluid on OCT (further defined as intraretinal, cystoid, subretinal fluid, or worsening pigment epithelial detachment) or the presence of a new hemorrhage on clinical examination.
11105679|NCT01617148|OG000|Outcome|Single Group|Subjects were included in the study if they met the following criteria: (1) active subfoveal choroidal neovascularization secondary to exudative Age-related Macular Degeneration (AMD) confirmed by fluorescein angiography (2) E-ETDRS vision of 25 to 80 letters (Snellen equivalent of ~20/25 to 20/320) (3) at least one prior injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab (Avastin and Lucentis, respectively; Genentech Inc, South San Francisco, California, USA) within 3 months of enrollment, and (4) had an initial response on optical coherence tomography (OCT) defined as a decrease of retinal edema and/or subretinal fluid to anti-Vascular Endothelial Growth Factor (anti-VEGF) injections followed by recurrent increase in fluid on OCT (further defined as intraretinal, cystoid, subretinal fluid, or worsening pigment epithelial detachment) or the presence of a new hemorrhage on clinical examination.
11105680|NCT01617148|EG000|Reported Event|Single Group|Subjects were included in the study if they met the following criteria: (1) active subfoveal choroidal neovascularization secondary to exudative AMD confirmed by fluorescein angiography (2) E-ETDRS vision of 25 to 80 letters (Snellen equivalent of ~20/25 to 20/320) (3) at least one prior injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab (Avastin and Lucentis, respectively; Genentech Inc, South San Francisco, CA, USA) within 3 months of enrollment, and (4) had an initial response on optical coherence tomography (OCT) defined as a decrease of retinal edema and/or subretinal fluid to anti-VEGF injections followed by recurrent increase in fluid on OCT (further defined as intraretinal, cystoid, subretinal fluid, or worsening pigment epithelial detachment) or the presence of a new hemorrhage on clinical examination.
11105681|NCT01617369|BG000|Baseline|Hypertonic Saline|"2.8% NaCl~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
11105682|NCT01617369|FG000|Participant Flow|Hypertonic Saline|"2.8% NaCl~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
11105683|NCT01617369|OG000|Outcome|Acute Hypertonic Saline Effect|"2.8% NaCl inhaled 30 minutes before MCC scan performed~Hypertonic Saline: 2.8% NaCl x 4ml via Pari LC STAR jet nebulizer"
11105684|NCT01617369|OG001|Outcome|Sustained Hypertonic Saline Effect|"2.8% NaCl Inhaled 4 hours before mucociliary clearance measured~Hypertonic saline = 2.8% NaCl x 4 ml delivered via Pari LC STAR jet nebulizer"
11105685|NCT01617369|EG000|Reported Event|Acute Hypertonic Saline Effect|"2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured.~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
11105686|NCT01617369|EG001|Reported Event|Sustained Hypertonic Saline Effect|"2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured.~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
11105687|NCT01617421|BG000|Baseline|Yoga|This study used Hatha yoga (influenced by Integral, Iyengar, and Kripalu yoga) which includes postures (asanas), breathing techniques (pranayama) and meditation [9]. Biweekly, 60-minute, bilingual yoga classes were offered for 8 weeks at a yoga studio in Washington, DC. Classes were kept small (3-10 participants) to allow for pose modifications as needed for each participant. Participants were given instructions, bilingual manuals, and yoga equipment to encourage home practice. Participants were asked to keep journals to document the frequency and duration of home practice and their experience while on the study. After the last class, a yoga DVD and a list of local yoga studios were given to encourage continued practice.
11126584|NCT01734382|OG000|Outcome|Part 1: Tocilizumab (TCZ) Q2W|Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants < 30 kg; 8 mg/kg for participants >/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study.
11105688|NCT01617421|FG000|Participant Flow|Yoga|This study used Hatha yoga (influenced by Integral, Iyengar, and Kripalu yoga) which includes postures (asanas), breathing techniques (pranayama) and meditation [9]. Biweekly, 60-minute, bilingual yoga classes were offered for 8 weeks at a yoga studio in Washington, DC. Classes were kept small (3-10 participants) to allow for pose modifications as needed for each participant. Participants were given instructions, bilingual manuals, and yoga equipment to encourage home practice. Participants were asked to keep journals to document the frequency and duration of home practice and their experience while on the study. After the last class, a yoga DVD and a list of local yoga studios were given to encourage continued practice.
11105689|NCT01617421|OG000|Outcome|Yoga|This study used Hatha yoga (influenced by Integral, Iyengar, and Kripalu yoga) which includes postures (asanas), breathing techniques (pranayama) and meditation [9]. Biweekly, 60-minute, bilingual yoga classes were offered for 8 weeks at a yoga studio in Washington, DC. Classes were kept small (3-10 participants) to allow for pose modifications as needed for each participant. Participants were given instructions, bilingual manuals, and yoga equipment to encourage home practice. Participants were asked to keep journals to document the frequency and duration of home practice and their experience while on the study. After the last class, a yoga DVD and a list of local yoga studios were given to encourage continued practice.
11105690|NCT01617421|EG000|Reported Event|Yoga|This study used Hatha yoga (influenced by Integral, Iyengar, and Kripalu yoga) which includes postures (asanas), breathing techniques (pranayama) and meditation [9]. Biweekly, 60-minute, bilingual yoga classes were offered for 8 weeks at a yoga studio in Washington, DC. Classes were kept small (3-10 participants) to allow for pose modifications as needed for each participant. Participants were given instructions, bilingual manuals, and yoga equipment to encourage home practice. Participants were asked to keep journals to document the frequency and duration of home practice and their experience while on the study. After the last class, a yoga DVD and a list of local yoga studios were given to encourage continued practice.
11105691|NCT01617434|BG000|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
11105692|NCT01617434|BG001|Baseline|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
11105693|NCT01617434|BG002|Baseline|Total|Total of all reporting groups
11105694|NCT01617434|FG000|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
11105695|NCT01617434|FG001|Participant Flow|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
11105696|NCT01617434|OG000|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
11105697|NCT01617434|OG001|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
11105698|NCT01617434|EG000|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
11105699|NCT01617434|EG001|Reported Event|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
11105700|NCT01617447|BG000|Baseline|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
11105701|NCT01617447|BG001|Baseline|Placebo|Placebo were orally administered once daily for 8 weeks.
11105702|NCT01617447|BG002|Baseline|Total|Total of all reporting groups
11105703|NCT01617447|FG000|Participant Flow|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
11105704|NCT01617447|FG001|Participant Flow|Placebo|Placebo were orally administered once daily for 8 weeks.
11105705|NCT01617447|OG000|Outcome|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
11105706|NCT01617447|OG001|Outcome|Placebo|Placebo were orally administered once daily for 8 weeks.
11105707|NCT01617447|EG000|Reported Event|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
11105708|NCT01617447|EG001|Reported Event|Placebo|Placebo were orally administered once daily for 8 weeks.
11105709|NCT01617460|BG000|Baseline|Aripiprazole|"Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.~The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner."
11105710|NCT01617460|FG000|Participant Flow|Aripiprazole|"Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.~The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner."
11105711|NCT01617460|OG000|Outcome|Aripiprazole|"Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.~The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner."
11105712|NCT01617460|EG000|Reported Event|Aripiprazole|"Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.~The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner."
11105713|NCT01617577|BG000|Baseline|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
11105714|NCT01617577|BG001|Baseline|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
11105715|NCT01617577|BG002|Baseline|Total|Total of all reporting groups
11105716|NCT01617577|FG000|Participant Flow|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
11105717|NCT01617577|FG001|Participant Flow|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
11105718|NCT01617577|OG000|Outcome|G-CSF|All participants received G-CSF either in the first or second phase of the crossover
11105719|NCT01617577|OG001|Outcome|Placebo|All participants received placebo either in the first or second phase of crossover
11105720|NCT01617577|OG000|Outcome|G-CSF and Placebo|All participants received G-CSF and placebo in crossover order
11105721|NCT01617577|EG000|Reported Event|Placebo|subjects who received placebo in either phase of the study
11105722|NCT01617577|EG001|Reported Event|G-CSF|participants who received GCSF injecitons during first or second phase
11105723|NCT01617603|BG000|Baseline|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105724|NCT01617603|BG001|Baseline|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105725|NCT01617603|BG002|Baseline|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105726|NCT01617603|BG003|Baseline|Total|Total of all reporting groups
11105727|NCT01617603|FG000|Participant Flow|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105728|NCT01617603|FG001|Participant Flow|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105729|NCT01617603|FG002|Participant Flow|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105730|NCT01617603|OG000|Outcome|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105731|NCT01617603|OG001|Outcome|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105732|NCT01617603|OG002|Outcome|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105733|NCT01617603|EG000|Reported Event|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105734|NCT01617603|EG001|Reported Event|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105735|NCT01617603|EG002|Reported Event|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
11105736|NCT01617629|BG000|Baseline|Cvac Treatment Group|"Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
11105737|NCT01617629|FG000|Participant Flow|Cvac Treatment Group|"Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
11105738|NCT01617629|OG000|Outcome|Cvac Treatment Group|"Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
11105739|NCT01617629|EG000|Reported Event|Cvac Treatment Group|"Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
11105740|NCT01617655|BG000|Baseline|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
11105741|NCT01617655|BG001|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
11105742|NCT01617655|BG002|Baseline|Total|Total of all reporting groups
11105743|NCT01617655|FG000|Participant Flow|Placebo Q2W|Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
11105744|NCT01617655|FG001|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
11105745|NCT01617655|OG000|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
11105746|NCT01617655|OG001|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
11105747|NCT01617655|OG000|Outcome|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 78 weeks).
11105748|NCT01617655|OG001|Outcome|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 78 weeks).
11105749|NCT01617655|EG000|Reported Event|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 71 weeks).
10846760|NCT00279812|BG006|Baseline|Total|Total of all reporting groups
11105750|NCT01617655|EG001|Reported Event|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 68 weeks).
11105751|NCT01617668|BG000|Baseline|Paclitaxel With LCL161|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105752|NCT01617668|BG001|Baseline|Paclitaxel Without LCL161|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105753|NCT01617668|BG002|Baseline|Total|Total of all reporting groups
11105754|NCT01617668|FG000|Participant Flow|Paclitaxel With LCL161 (Positive Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105755|NCT01617668|FG001|Participant Flow|Paclitaxel Without LCL161 (Positive Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105756|NCT01617668|FG002|Participant Flow|Paclitaxel With LCL161 (Negative Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105757|NCT01617668|FG003|Participant Flow|Paclitaxel Without LCL161 (Negative Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105758|NCT01617668|OG000|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105759|NCT01617668|OG001|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105760|NCT01617668|OG002|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105761|NCT01617668|OG003|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105762|NCT01617668|OG000|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm who received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
11105763|NCT01617668|OG000|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
11105764|NCT01617668|OG000|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
11105765|NCT01617668|OG001|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
11105766|NCT01617668|OG000|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105767|NCT01617668|OG000|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
11105768|NCT01617668|EG000|Reported Event|LCL161+PACLITAXEL|Patients randomized to the experimental arm for gene expression signature positive/negative received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105769|NCT01617668|EG001|Reported Event|PACLITAXEL|Patients randomized to the control arm for gene expression signature positive/negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
11105770|NCT01617681|BG000|Baseline|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
11105771|NCT01617681|BG001|Baseline|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
11105772|NCT01617681|BG002|Baseline|Non-CKD Patients Valsartan 0.25 mg/kg|Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
11105773|NCT01617681|BG003|Baseline|Non-CKD Patients Valsartan 4 mg/kg|Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
11105774|NCT01617681|BG004|Baseline|Total|Total of all reporting groups
11105775|NCT01617681|FG000|Participant Flow|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
10846761|NCT00279812|FG000|Participant Flow|Placebo|"Placebo~Selenomethionine (supplement) and selenium enriched onions"
10846762|NCT00279812|FG001|Participant Flow|50ug Selenium Enriched Yeast|Selenomethionine supplement (50ug/d Se) for 12 weeks
11105776|NCT01617681|FG001|Participant Flow|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
11105777|NCT01617681|FG002|Participant Flow|Non-CKD Patients Valsartan 0.25 mg/kg|Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
11105778|NCT01617681|FG003|Participant Flow|Non-CKD Patients Valsartan 4 mg/kg|Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
11105779|NCT01617681|FG004|Participant Flow|Valsartan 1 mg/kg (Period 2)|Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
11105780|NCT01617681|OG000|Outcome|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
11105781|NCT01617681|OG001|Outcome|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
11105782|NCT01617681|OG002|Outcome|Non-CKD Patients Valsartan 0.25 mg/kg|Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
11105783|NCT01617681|OG003|Outcome|Non-CKD Patients Valsartan 4 mg/kg|Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
11105784|NCT01617681|EG000|Reported Event|Valsartan 0.25 mg/kg|All Patients CKD & Non-CKD: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
11105785|NCT01617681|EG001|Reported Event|Valsartan 4.0 mg/kg|All Patients CKD & Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
11105786|NCT01617681|EG002|Reported Event|All Open Label Patients|Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
11105787|NCT01617967|BG000|Baseline|Patisiran 0.010 mg/kg Q4W|Participants received 0.010 mg/kg of patisiran (ALN-TTR02) every four weeks (Q4W).
11105788|NCT01617967|BG001|Baseline|Patisiran 0.050 mg/kg Q4W|Participants received 0.050 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105789|NCT01617967|BG002|Baseline|Patisiran 0.150 mg/kg Q4W|Participants received 0.150 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105790|NCT01617967|BG003|Baseline|Patisiran 0.300 mg/kg Q4W|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105791|NCT01617967|BG004|Baseline|Patisiran 0.300 mg/kg Q3W|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks (Q3W).
11105792|NCT01617967|BG005|Baseline|Patisiran 0.300 mg/kg Q3W Alternative|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks with alternative premedication regimen.
11105793|NCT01617967|BG006|Baseline|Total|Total of all reporting groups
11105794|NCT01617967|FG000|Participant Flow|Patisiran 0.010 mg/kg Q4W|Participants received 0.010 mg/kg of patisiran (ALN-TTR02) every four weeks (Q4W).
11105795|NCT01617967|FG001|Participant Flow|Patisiran 0.050 mg/kg Q4W|Participants received 0.050 mg/kg of patisiran (ALN-TTR02) every four weeks.
10846763|NCT00279812|FG002|Participant Flow|100ug Selenium Enriched Yeast|Selenomethionine supplement (100ug/d Se) for 12 weeks
11105796|NCT01617967|FG002|Participant Flow|Patisiran 0.150 mg/kg Q4W|Participants received 0.150 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105797|NCT01617967|FG003|Participant Flow|Patisiran 0.300 mg/kg Q4W|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105798|NCT01617967|FG004|Participant Flow|Patisiran 0.300 mg/kg Q3W|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks (Q3W).
11105799|NCT01617967|FG005|Participant Flow|Patisiran 0.300 mg/kg Q3W Alternative|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks with alternative premedication regimen.
11105800|NCT01617967|OG000|Outcome|Patisiran 0.010 mg/kg Q4W|Participants received 0.010 mg/kg of patisiran (ALN-TTR02) every four weeks (Q4W).
11105801|NCT01617967|OG001|Outcome|Patisiran 0.050 mg/kg Q4W|Participants received 0.050 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105802|NCT01617967|OG002|Outcome|Patisiran 0.150 mg/kg Q4W|Participants received 0.150 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105803|NCT01617967|OG003|Outcome|Patisiran 0.300 mg/kg Q4W|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105804|NCT01617967|OG004|Outcome|Patisiran 0.300 mg/kg Q3W|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks (Q3W).
11105805|NCT01617967|OG005|Outcome|Patisiran 0.300 mg/kg Q3W Alternative|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks with alternative premedication regimen.
11105806|NCT01617967|OG004|Outcome|All Patisiran 0.300 mg/kg Q3W|All participants, who received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks irrespective of premedication regimen.
11105807|NCT01617967|EG000|Reported Event|Patisiran 0.010 mg/kg Q4W|Participants received 0.010 mg/kg of patisiran (ALN-TTR02) every four weeks (Q4W).
11105808|NCT01617967|EG001|Reported Event|Patisiran 0.050 mg/kg Q4W|Participants received 0.050 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105809|NCT01617967|EG002|Reported Event|Patisiran 0.150 mg/kg Q4W|Participants received 0.150 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105810|NCT01617967|EG003|Reported Event|Patisiran 0.300 mg/kg Q4W|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every four weeks.
11105811|NCT01617967|EG004|Reported Event|Patisiran 0.300 mg/kg Q3W|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks (Q3W).
11105812|NCT01617967|EG005|Reported Event|Patisiran 0.300 mg/kg Q3W Alternative|Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks with alternative premedication regimen.
11105813|NCT01618019|BG000|Baseline|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
11105814|NCT01618019|BG001|Baseline|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
11105815|NCT01618019|BG002|Baseline|Total|Total of all reporting groups
11105816|NCT01618019|FG000|Participant Flow|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
11105817|NCT01618019|FG001|Participant Flow|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
11105818|NCT01618019|OG000|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
11105819|NCT01618019|OG001|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
11105820|NCT01618019|EG000|Reported Event|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
11105821|NCT01618019|EG001|Reported Event|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
10879525|NCT00458341|OG000|Outcome|Ataluren 4, 4, and 8 mg/kg, Then Ataluren 10, 10, and 20 mg/kg|During Cycle 1, participants received ataluren at 4 mg/kg in the morning, 4 mg/kg at midday, and 8 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. Then, the participants crossed over to the other ataluren dose regimen (ataluren 10, 10, and 20 mg/kg) for Cycle 2.
11105822|NCT01618162|BG000|Baseline|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
11105823|NCT01618162|BG001|Baseline|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
11105824|NCT01618162|BG002|Baseline|Total|Total of all reporting groups
11105825|NCT01618162|FG000|Participant Flow|IDegLira|In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
11105826|NCT01618162|FG001|Participant Flow|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
11105827|NCT01618162|OG000|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
11105828|NCT01618162|OG001|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
11105829|NCT01618162|EG000|Reported Event|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
11224514|NCT02360475|OG002|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11105830|NCT01618162|EG001|Reported Event|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
11105831|NCT01618214|BG000|Baseline|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
11105832|NCT01618214|BG001|Baseline|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
11105833|NCT01618214|BG002|Baseline|Total|Total of all reporting groups
11105834|NCT01618214|FG000|Participant Flow|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
11105835|NCT01618214|FG001|Participant Flow|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
11105836|NCT01618214|OG000|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
11105837|NCT01618214|OG001|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
11105838|NCT01618214|EG000|Reported Event|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
11105839|NCT01618214|EG001|Reported Event|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
11224515|NCT02360475|OG003|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
10846764|NCT00279812|FG003|Participant Flow|200ug Selenium Enriched Yeast|Selenomethionine supplement (200ug/d Se) for 12 weeks
10846765|NCT00279812|FG004|Participant Flow|Control Onion|3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
10846766|NCT00279812|FG005|Participant Flow|Enriched Onion|3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
10846767|NCT00279812|OG000|Outcome|Placebo|"Placebo~Selenomethionine (supplement) and selenium enriched onions"
11105840|NCT01618227|BG000|Baseline|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
11105841|NCT01618227|BG001|Baseline|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
11105842|NCT01618227|BG002|Baseline|Total|Total of all reporting groups
11105843|NCT01618227|FG000|Participant Flow|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
11105844|NCT01618227|FG001|Participant Flow|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
11105845|NCT01618227|OG000|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
11105846|NCT01618227|OG001|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
11105847|NCT01618227|EG000|Reported Event|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
11105848|NCT01618227|EG001|Reported Event|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
11105849|NCT01618240|BG000|Baseline|Baseline Population|Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital.
11105850|NCT01618240|FG000|Participant Flow|Long-term Ventilated Subjects|Long-term (>10 days hours) ventilated subjects were included.
11105851|NCT01618240|OG000|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
11105852|NCT01618240|EG000|Reported Event|Long-term Ventilated Subjects|30 consented long-term ventilated patients
10846768|NCT00279812|OG001|Outcome|50ug Selenium Enriched Yeast|Selenomethionine supplement (50ug/d Se) for 12 weeks
11105853|NCT01618266|BG000|Baseline|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
11105854|NCT01618266|FG000|Participant Flow|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
11105855|NCT01618266|OG000|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
11105856|NCT01618266|EG000|Reported Event|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
11105857|NCT01618305|BG000|Baseline|Arm A (Women)|"Pregnant women received ZDV/3TC + EFV~Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.~Efavirenz: Participants received one 600 mg tablet of efavirenz each night from entry through delivery."
11105858|NCT01618305|BG001|Baseline|Arm B (Women)|"Pregnant women received ZDV/3TC + RAL~Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.~Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery."
11105859|NCT01618305|BG002|Baseline|Total|Total of all reporting groups
11224516|NCT02360475|EG000|Reported Event|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11105860|NCT01618305|FG000|Participant Flow|Arm A (Women)|"Pregnant women received ZDV/3TC + EFV~Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.~Efavirenz: Participants received one 600 mg tablet of efavirenz each night from entry through delivery."
11105861|NCT01618305|FG001|Participant Flow|Arm B (Women)|"Pregnant women received ZDV/3TC + RAL~Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.~Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery."
11105862|NCT01618305|OG000|Outcome|Arm A (Women)|"Pregnant women received ZDV/3TC + EFV~Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.~Efavirenz: Participants received one 600 mg tablet of efavirenz each night from entry through delivery."
11105863|NCT01618305|OG001|Outcome|Arm B (Women)|"Pregnant women received ZDV/3TC + RAL~Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.~Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery."
11105864|NCT01618305|OG000|Outcome|Arm A (Infants)|Infants born to women in Arm A; infants received no study intervention.
11105865|NCT01618305|OG001|Outcome|Arm B (Infants)|Infants born to women in Arm B; infants received no study intervention.
11105866|NCT01618305|EG000|Reported Event|Arm A (Women)|"Pregnant women received ZDV/3TC + EFV~Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.~Efavirenz: Participants received one 600 mg tablet of efavirenz each night from entry through delivery."
11105867|NCT01618305|EG001|Reported Event|Arm B (Women)|"Pregnant women received ZDV/3TC + RAL~Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.~Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery."
11105868|NCT01618305|EG002|Reported Event|Arm A (Infants)|Infants born to women in Arm A; infants received no study intervention.
11105869|NCT01618305|EG003|Reported Event|Arm B (Infants)|Infants born to women in Arm B; infants received no study intervention.
11105870|NCT01618344|BG000|Baseline|Participants|All participants
11105871|NCT01618344|FG000|Participant Flow|Smart-phone Medication Reminder Application|All participants were provided with the medication reminder application, and were instructed on how to program the application based on their individual medication dosing schedules. At the scheduled times, the application prompted participants to take their medications.
11105872|NCT01618344|OG000|Outcome|Participants|All participants
11105873|NCT01618344|EG000|Reported Event|Participants|All participants
11105874|NCT01618422|BG000|Baseline|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin.
11105875|NCT01618422|BG001|Baseline|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
11105876|NCT01618422|BG002|Baseline|Total|Total of all reporting groups
11105877|NCT01618422|FG000|Participant Flow|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
11105878|NCT01618422|FG001|Participant Flow|DOTS Plus|"The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.~Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and"
11105879|NCT01618422|OG000|Outcome|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
11105880|NCT01618422|OG001|Outcome|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
11105881|NCT01618422|EG000|Reported Event|DOTS Strategy|The DOTS strategy (current strategy) consists of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment. The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin (2HRZE/4HR or 2HRZS/4HR). In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used (2HRZES/1HRZE/5HRE).
11105882|NCT01618422|EG001|Reported Event|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
11105883|NCT01618669|BG000|Baseline|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105884|NCT01618669|BG001|Baseline|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105885|NCT01618669|BG002|Baseline|Total|Total of all reporting groups
11105886|NCT01618669|FG000|Participant Flow|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT myocardial perfusion imaging (MPI). One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
10846769|NCT00279812|OG002|Outcome|100ug Selenium Enriched Yeast|Selenomethionine supplement (100ug/d Se) for 12 weeks
10846770|NCT00279812|OG003|Outcome|200ug Selenium Enriched Yeast|Selenomethionine supplement (200ug/d Se) for 12 weeks
10846771|NCT00279812|OG004|Outcome|Control Onion|3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
10846772|NCT00279812|OG005|Outcome|Enriched Onion|3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
10846773|NCT00279812|EG000|Reported Event|Placebo|"Placebo~Selenomethionine (supplement) and selenium enriched onions"
10846774|NCT00279812|EG001|Reported Event|50ug Selenium Enriched Yeast|Selenomethionine supplement (50ug/d Se) for 12 weeks
10846775|NCT00279812|EG002|Reported Event|100ug Selenium Enriched Yeast|Selenomethionine supplement (100ug/d Se) for 12 weeks
10846776|NCT00279812|EG003|Reported Event|200ug Selenium Enriched Yeast|Selenomethionine supplement (200ug/d Se) for 12 weeks
10846777|NCT00279812|EG004|Reported Event|Control Onion|3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
10846778|NCT00279812|EG005|Reported Event|Enriched Onion|3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
10846779|NCT00279916|BG000|Baseline|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
10846780|NCT00279916|BG001|Baseline|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
10846781|NCT00279916|BG002|Baseline|Total|Total of all reporting groups
10846782|NCT00279916|FG000|Participant Flow|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
10846783|NCT00279916|FG001|Participant Flow|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
10846784|NCT00279916|OG000|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
11105887|NCT01618669|FG001|Participant Flow|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105888|NCT01618669|OG000|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105889|NCT01618669|OG001|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105890|NCT01618669|OG000|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105891|NCT01618669|OG001|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105892|NCT01618669|OG002|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105893|NCT01618669|OG003|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105894|NCT01618669|OG000|Outcome|REG APEX: MPI 2 SDS 0-6|Participants in the Regadenoson After Peak Exercise (APEX) group who had an SDS from 0 to 6 on their second stress scan.
11105895|NCT01618669|OG001|Outcome|REG APEX: MPI 2 7-13|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS from 7 to 13 on their second stress scan.
11105896|NCT01618669|OG002|Outcome|REG APEX: MPI 2 SDS ≥ 14|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS ≥ 14 on their second stress scan.
11105897|NCT01618669|OG003|Outcome|REG Alone: MPI 2 SDS 0-6|Participants in the Regadenoson (REG) Alone group who had an SDS from 0 to 6 on their second stress scan.
11105898|NCT01618669|OG004|Outcome|REG Alone: MPI 2 SDS 7-13|Participants in the Regadenoson (REG) Alone group who had an SDS from 7 to 13 on their second stress scan.
11105899|NCT01618669|OG005|Outcome|REG Alone: MPI 2 SDS ≥ 14|Participants in the Regadenoson (REG) Alone group who had an SDS ≥ 14 on their second stress scan.
11105900|NCT01618669|EG000|Reported Event|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105901|NCT01618669|EG001|Reported Event|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
10846785|NCT00279916|OG001|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
10846786|NCT00279916|EG000|Reported Event|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
10846787|NCT00279916|EG001|Reported Event|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
10846788|NCT00279955|BG000|Baseline|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
10846789|NCT00279955|BG001|Baseline|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
10846790|NCT00279955|BG002|Baseline|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
10846791|NCT00279955|BG003|Baseline|Total|Total of all reporting groups
10846792|NCT00279955|FG000|Participant Flow|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
10846793|NCT00279955|FG001|Participant Flow|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
10846794|NCT00279955|FG002|Participant Flow|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
10846795|NCT00279955|OG000|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
11105902|NCT01618669|EG002|Reported Event|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105903|NCT01618669|EG003|Reported Event|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
11105904|NCT01618695|BG000|Baseline|Core Phase: Placebo|Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
11105905|NCT01618695|BG001|Baseline|Core Phase: Perampanel 4 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105906|NCT01618695|BG002|Baseline|Core Phase: Perampanel 8 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105907|NCT01618695|BG003|Baseline|Core Phase: Perampanel 12 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105908|NCT01618695|BG004|Baseline|Total|Total of all reporting groups
11105909|NCT01618695|FG000|Participant Flow|Core Phase: Placebo; Extension Phase: up to 12 mg Perampanel|Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks) in the Core Phase. Participants received placebo in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 2 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
11105910|NCT01618695|FG001|Participant Flow|Core Phase: Perampanel 4 mg; Extension Phase: up to 12 mg Perampanel|Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally, once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period in Core Phase was 19 weeks. Participants received the same dose of perampanel 4 mg in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 4 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
11105911|NCT01618695|FG002|Participant Flow|Core Phase: Perampanel 8 mg; Extension Phase: up to 12 mg Perampanel|Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally, once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 8 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 8 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
11105912|NCT01618695|FG003|Participant Flow|Core Phase/Extension Phase: up to 12 mg Perampanel|Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally, once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 12 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period) and continued receiving perampanel 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
10846796|NCT00279955|OG001|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
11105913|NCT01618695|OG000|Outcome|Placebo|Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
11105914|NCT01618695|OG001|Outcome|Perampanel 4 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105915|NCT01618695|OG002|Outcome|Perampanel 8 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105916|NCT01618695|OG003|Outcome|Perampanel 12 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105917|NCT01618695|EG000|Reported Event|Core Phase: Placebo|Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
11105918|NCT01618695|EG001|Reported Event|Core Phase: Perampanel 4 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105919|NCT01618695|EG002|Reported Event|Core Phase: Perampanel 8 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105920|NCT01618695|EG003|Reported Event|Core Phase: Perampanel 12 mg|Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
11105921|NCT01618695|EG004|Reported Event|Extension Phase: Perampanel 12 mg|Participants received the same dose of perampanel in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). This dose was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). Participants who received perampanel matched-placebo in Core Phase were given perampanel 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). All participants were allowed to have their dose down or up titrated until an optimal dose was reached. A maintenance period was followed by conversion period in which participants received perampanel dose of 12 mg, orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country.
11105922|NCT01618708|BG000|Baseline|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
11105923|NCT01618708|BG001|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
11105924|NCT01618708|BG002|Baseline|Total|Total of all reporting groups
11105925|NCT01618708|FG000|Participant Flow|Placebo|Single 6 mL intraarticular (IA) injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
11105926|NCT01618708|FG001|Participant Flow|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
11105927|NCT01618708|OG000|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
11105928|NCT01618708|OG001|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
11105929|NCT01618708|OG000|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
11105930|NCT01618708|EG000|Reported Event|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
11105931|NCT01618708|EG001|Reported Event|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
11105932|NCT01618838|BG000|Baseline|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
11224517|NCT02360475|EG001|Reported Event|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11105933|NCT01618838|FG000|Participant Flow|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
11105934|NCT01618838|OG000|Outcome|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
11105935|NCT01618838|OG000|Outcome|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the Planning Treatment Volume (PTV) and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
11105936|NCT01618838|EG000|Reported Event|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
11105937|NCT01618864|BG000|Baseline|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
11105938|NCT01618864|FG000|Participant Flow|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
11105939|NCT01618864|OG000|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
11105940|NCT01618864|OG001|Outcome|Luxe Treatment Group at 8 Weeks|GAI assessment by investigator at 8 weeks.
11105941|NCT01618864|OG000|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by assessment.
11105942|NCT01618864|OG001|Outcome|Luxe Treatment Group at 8 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks and assessment at week 8.
11105943|NCT01618864|OG000|Outcome|Luxe Treatment Group at 4 Weeks|Subjects with rosacea were evaluated by the investigator and a score provided according to a validated rosacea scale for improvement in features of rosacea such as flushing.
11105944|NCT01618864|OG001|Outcome|Luxe Treatment Group at 8 Weeks|Evaluation of rosacea after 8 weeks of treatment.
11105945|NCT01618864|EG000|Reported Event|Treatment Group|All treated subjects were evaluated for adverse events during the study.
11105946|NCT01618916|BG000|Baseline|1.0 mg/kg LY3015014 Q2W|LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105947|NCT01618916|BG001|Baseline|1.0 mg/kg LY3015014 Q4W|LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105948|NCT01618916|BG002|Baseline|3.0 mg/kg LY3015014 Q2W|LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105949|NCT01618916|BG003|Baseline|3.0 mg/kg LY3015014 Q4W|LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105950|NCT01618916|BG004|Baseline|Placebo Q2W|Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105951|NCT01618916|BG005|Baseline|Placebo Q4W|Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105952|NCT01618916|BG006|Baseline|Total|Total of all reporting groups
11105953|NCT01618916|FG000|Participant Flow|1.0 mg/kg LY3015014 Q2W|LY3015014: 1.0 milligrams per kilogram (mg/kg) given as subcutaneous (SC) injection every 2 weeks (Q2W) on Days 1, 15, and 29 for a total of 3 doses.
11105954|NCT01618916|FG001|Participant Flow|1.0 mg/kg LY3015014 Q4W|LY3015014: 1.0 mg/kg given as SC injection every 4 weeks (Q4W) on Days 1 and 29 for a total of 2 doses.
11105955|NCT01618916|FG002|Participant Flow|3.0 mg/kg LY3015014 Q2W|LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105956|NCT01618916|FG003|Participant Flow|3.0 mg/kg LY3015014 Q4W|LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105957|NCT01618916|FG004|Participant Flow|Placebo Q2W|Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105958|NCT01618916|FG005|Participant Flow|Placebo Q4W|Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105959|NCT01618916|OG000|Outcome|1.0 mg/kg LY3015014 Q2W|LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105960|NCT01618916|OG001|Outcome|1.0 mg/kg LY3015014 Q4W|LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105961|NCT01618916|OG002|Outcome|3.0 mg/kg LY3015014 Q2W|LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105962|NCT01618916|OG003|Outcome|3.0 mg/kg LY3015014 Q4W|LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105963|NCT01618916|OG004|Outcome|Placebo Q2W Plus Placebo Q4W|Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses and Q4W on Days 1 and 29 for a total of 2 doses.
11105964|NCT01618916|EG000|Reported Event|1.0 mg/kg LY3015014 Q2W|LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105965|NCT01618916|EG001|Reported Event|1.0 mg/kg LY3015014 Q4W|LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105966|NCT01618916|EG002|Reported Event|3.0 mg/kg LY3015014 Q2W|LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
10846797|NCT00279955|EG000|Reported Event|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
11105967|NCT01618916|EG003|Reported Event|3.0 mg/kg LY3015014 Q4W|LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105968|NCT01618916|EG004|Reported Event|Placebo Q2W|Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
11105969|NCT01618916|EG005|Reported Event|Placebo Q4W|Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
11105970|NCT01618942|BG000|Baseline|Male Subjects|grouped by gender
11105971|NCT01618942|BG001|Baseline|Female Subjects|grouped by gender
11105972|NCT01618942|BG002|Baseline|Total|Total of all reporting groups
11105973|NCT01618942|FG000|Participant Flow|Male Subjects|grouped by gender and applied with hand-held pressure algometer with differen
11105974|NCT01618942|FG001|Participant Flow|Female Subjects|grouped by gender grouped by gender and applied with hand-held pressure algometer with differen
11105975|NCT01618942|OG000|Outcome|Male Subjects|grouped by gender
11105976|NCT01618942|OG001|Outcome|Female Subjects|grouped by gender
11105977|NCT01618942|EG000|Reported Event|Male Subjects|grouped by gender
11105978|NCT01618942|EG001|Reported Event|Female Subjects|grouped by gender
11105979|NCT01618955|BG000|Baseline|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
11105980|NCT01618955|BG001|Baseline|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
11105981|NCT01618955|BG002|Baseline|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
11105982|NCT01618955|BG003|Baseline|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
11105983|NCT01618955|BG004|Baseline|Total|Total of all reporting groups
11105984|NCT01618955|FG000|Participant Flow|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
11105985|NCT01618955|FG001|Participant Flow|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
11105986|NCT01618955|FG002|Participant Flow|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
11105987|NCT01618955|FG003|Participant Flow|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
11105988|NCT01618955|OG000|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
11105989|NCT01618955|OG001|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
11105990|NCT01618955|OG002|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
11105991|NCT01618955|OG003|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
11105992|NCT01618955|EG000|Reported Event|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
11105993|NCT01618955|EG001|Reported Event|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
11105994|NCT01618955|EG002|Reported Event|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
11105995|NCT01618955|EG003|Reported Event|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
11105996|NCT01618968|BG000|Baseline|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11105997|NCT01618968|BG001|Baseline|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11105998|NCT01618968|BG002|Baseline|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11105999|NCT01618968|BG003|Baseline|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106000|NCT01618968|BG004|Baseline|Total|Total of all reporting groups
11106001|NCT01618968|FG000|Participant Flow|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106002|NCT01618968|FG001|Participant Flow|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106003|NCT01618968|FG002|Participant Flow|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106004|NCT01618968|FG003|Participant Flow|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106005|NCT01618968|OG000|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
11106006|NCT01618968|OG001|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
11106007|NCT01618968|OG002|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
11106008|NCT01618968|EG000|Reported Event|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106009|NCT01618968|EG001|Reported Event|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106010|NCT01618968|EG002|Reported Event|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106011|NCT01618968|EG003|Reported Event|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
11106012|NCT01619059|BG000|Baseline|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
11106013|NCT01619059|BG001|Baseline|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
11106014|NCT01619059|BG002|Baseline|Total|Total of all reporting groups
11106015|NCT01619059|FG000|Participant Flow|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
11106016|NCT01619059|FG001|Participant Flow|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
11106017|NCT01619059|OG000|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
11106018|NCT01619059|OG001|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
11106019|NCT01619059|EG000|Reported Event|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
11106020|NCT01619059|EG001|Reported Event|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
11106021|NCT01619410|BG000|Baseline|Linezolid|Linezolid: Linezolid 600 mg every 12 hours for 7 days
11106022|NCT01619410|BG001|Baseline|Clindamycin|Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
11106023|NCT01619410|BG002|Baseline|Total|Total of all reporting groups
11106024|NCT01619410|FG000|Participant Flow|Linezolid|Linezolid: Linezolid 600 mg every 12 hours for 7 days
11106025|NCT01619410|FG001|Participant Flow|Clindamycin|Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
11106026|NCT01619410|OG000|Outcome|Linezolid|Linezolid: Linezolid 600 mg every 12 hours for 7 days
11106027|NCT01619410|OG001|Outcome|Clindamycin|Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
11106028|NCT01619410|EG000|Reported Event|Linezolid|Linezolid: Linezolid 600 mg every 12 hours for 7 days
11106029|NCT01619410|EG001|Reported Event|Clindamycin|Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
11106030|NCT01619423|BG000|Baseline|FOLFOX6 + 0,9% NaCl (Part 2a+2b)|"Placebo= 0.9% NaCl; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~Placebo (0,9% NaCl): Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106031|NCT01619423|BG001|Baseline|FOLFOX6 + PledOx 2 µmol/kg (Part 1, 2a+2b)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106032|NCT01619423|BG002|Baseline|FOLFOX6 + PledOx 5 µmol/kg (Part 1, 2b)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (5 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106033|NCT01619423|BG003|Baseline|FOLFOX6 + PledOx 10 µmol/kg (Part 1, 2a)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (10 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106034|NCT01619423|BG004|Baseline|Total|Total of all reporting groups
11106035|NCT01619423|FG000|Participant Flow|FOLFOX6 + 0,9% NaCl (Part 2a+2b)|"Placebo= 0.9% NaCl; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~Placebo (0,9% NaCl): Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106036|NCT01619423|FG001|Participant Flow|FOLFOX6 + PledOx 2 µmol/kg (Part 1, 2a+2b)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106037|NCT01619423|FG002|Participant Flow|FOLFOX6 + PledOx 5 µmol/kg (Part 1, 2b)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (5 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106038|NCT01619423|FG003|Participant Flow|FOLFOX6 + PledOx 10 µmol/kg (Part 1, 2a)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (10 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106039|NCT01619423|OG000|Outcome|Placebo|Control group
11106040|NCT01619423|OG001|Outcome|FOLFOX6 + PledOx 2 µmol/kg|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106041|NCT01619423|OG002|Outcome|FOLFOX6 + PledOx 5+10 µmol/kg|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~Combined PledOx (5 and 10 µmol/kg groups): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106042|NCT01619423|OG003|Outcome|FOLFOX6 + PledOx 2+5+10 µmol/kg|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~Combined PledOx (2, 5 and 10 µmol/kg groups): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106043|NCT01619423|EG000|Reported Event|FOLFOX6 + 0,9% NaCl (Part 2a+2b)|"Placebo= 0.9% NaCl; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~Placebo (0,9% NaCl): Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106044|NCT01619423|EG001|Reported Event|Part 1 (Dose Escalation)|Part 1 is an open dose-escalation part with the doses 2, 5 and 10 µmol/kg of PledOx with the active ingridient calmangafodipir
11106045|NCT01619423|EG002|Reported Event|FOLFOX6 + PledOx 2 µmol/kg (Part 2a+2b)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106046|NCT01619423|EG003|Reported Event|FOLFOX6 + PledOx 5 µmol/kg (Part 2b)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (5 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106047|NCT01619423|EG004|Reported Event|FOLFOX6 + PledOx 10 µmol/kg (Part 2a)|"PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.~PledOx (10 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles."
11106048|NCT01619579|BG000|Baseline|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
11106049|NCT01619579|BG001|Baseline|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
11106050|NCT01619579|BG002|Baseline|Total|Total of all reporting groups
11106051|NCT01619579|FG000|Participant Flow|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily.
11106052|NCT01619579|FG001|Participant Flow|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily.
11106053|NCT01619579|OG000|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
11106054|NCT01619579|OG001|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
11106055|NCT01619579|EG000|Reported Event|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
11106056|NCT01619579|EG001|Reported Event|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
11106057|NCT01619774|BG000|Baseline|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
11106058|NCT01619774|FG000|Participant Flow|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
11106059|NCT01619774|OG000|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
11106060|NCT01619774|EG000|Reported Event|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
11106061|NCT01619787|BG000|Baseline|Lean Participants|"Participants whose baseline BMI is less than 25.~All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
11106062|NCT01619787|BG001|Baseline|Overweight/Obese Participants|"Participants whose baseline BMI is greater than or equal to 25.~All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
11106063|NCT01619787|BG002|Baseline|Total|Total of all reporting groups
11106064|NCT01619787|FG000|Participant Flow|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
11106065|NCT01619787|OG000|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
11106066|NCT01619787|OG001|Outcome|Lean Participants|Participants with BMI less than 25.
11106067|NCT01619787|OG002|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
11106068|NCT01619787|EG000|Reported Event|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy, along with the Three Factor Eating Questionnaire were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
11106069|NCT01619839|BG000|Baseline|100 mg NKTR-181|"100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days.~NKTR-181"
11106070|NCT01619839|BG001|Baseline|200 mg NKTR-181|"200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days.~NKTR-181"
11106071|NCT01619839|BG002|Baseline|300 mg NKTR-181|"300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days~NKTR-181"
11106072|NCT01619839|BG003|Baseline|400 mg NKTR-181|"400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days~NKTR-181"
11106073|NCT01619839|BG004|Baseline|Placebo|"Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.~Placebo: Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181"
11106074|NCT01619839|BG005|Baseline|Total|Total of all reporting groups
11106075|NCT01619839|FG000|Participant Flow|100 mg NKTR-181|"100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days.~NKTR-181"
11106076|NCT01619839|FG001|Participant Flow|200 mg NKTR-181|"200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days.~NKTR-181"
11106077|NCT01619839|FG002|Participant Flow|300 mg NKTR-181|"300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days~NKTR-181"
11106078|NCT01619839|FG003|Participant Flow|400 mg NKTR-181|"400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days~NKTR-181"
11106079|NCT01619839|FG004|Participant Flow|Placebo|"Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.~Placebo: Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181"
11106080|NCT01619839|OG000|Outcome|NKTR-181|Patients who received at least one dose of NKTR-181
11106081|NCT01619839|OG001|Outcome|Placebo|Patients given placebo
11106082|NCT01619839|EG000|Reported Event|100 mg NKTR-181|"100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days.~NKTR-181"
11106083|NCT01619839|EG001|Reported Event|200 mg NKTR-181|"200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days.~NKTR-181"
11106084|NCT01619839|EG002|Reported Event|300 mg NKTR-181|"300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days~NKTR-181"
11106085|NCT01619839|EG003|Reported Event|400 mg NKTR-181|"400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days~NKTR-181"
11106086|NCT01619839|EG004|Reported Event|Placebo|"Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.~Placebo: Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181"
11106087|NCT01619852|BG000|Baseline|Group L|"Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.~Group L (lidocaine): Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure."
11106088|NCT01619852|BG001|Baseline|.9% Normal Saline Placebo|".9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.~.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure."
11106089|NCT01619852|BG002|Baseline|Total|Total of all reporting groups
11106090|NCT01619852|FG000|Participant Flow|Lidocaine (Group L)|Lidocaine (Group L) will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.
11106091|NCT01619852|FG001|Participant Flow|.9% Normal Saline Placebo|".9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.~.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure."
11106092|NCT01619852|OG000|Outcome|Group L|"Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.~Group L (lidocaine): Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure."
11106093|NCT01619852|OG001|Outcome|.9% Normal Saline Placebo|".9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.~.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure."
11106094|NCT01619852|OG000|Outcome|Lidocaine (Group L)|"Lidocaine (Group L) will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.~Lidocaine (Group L): will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure."
11106095|NCT01619852|EG000|Reported Event|Group L|"Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.~Group L (lidocaine): Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure."
11106096|NCT01619852|EG001|Reported Event|.9% Normal Saline Placebo|".9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.~.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure."
11106097|NCT01619865|BG000|Baseline|68Ga-DOTATOC PET/CT|"68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors~68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV."
11106098|NCT01619865|FG000|Participant Flow|68Ga-DOTATOC PET/CT|"68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors~68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV."
11106099|NCT01619865|OG000|Outcome|68Ga-DOTATOC PET/CT|"68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors~68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV."
11106100|NCT01619865|OG000|Outcome|68Ga-DOTATOC PET/CT|"68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors~68Ga-DOTATOC PET/CT: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV."
11106101|NCT01619865|EG000|Reported Event|68Ga-DOTATOC PET/CT|"68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors~68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV."
11106102|NCT01619878|BG000|Baseline|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
11106103|NCT01619878|FG000|Participant Flow|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
11106104|NCT01619878|OG000|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
11106105|NCT01619878|EG000|Reported Event|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
11106106|NCT01619982|BG000|Baseline|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or at 12 hours if patient younger than 1 month of age."
11106107|NCT01619982|BG001|Baseline|Cefazolin 30 mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
11106108|NCT01619982|BG002|Baseline|Total|Total of all reporting groups
11106109|NCT01619982|FG000|Participant Flow|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or at 12 hours if patient younger than 1 month of age."
11106110|NCT01619982|FG001|Participant Flow|Cefazolin 30 mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
11106111|NCT01619982|OG000|Outcome|Cefazolin 25mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
11106112|NCT01619982|OG001|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
11106113|NCT01619982|OG000|Outcome|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
11106114|NCT01619982|OG001|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
11106115|NCT01619982|OG000|Outcome|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
11106116|NCT01619982|OG001|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin pre-operative prophylaxis: Cefazolin 30 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (30mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
11106117|NCT01619982|EG000|Reported Event|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
11106118|NCT01619982|EG001|Reported Event|Cefazolin30 mg/kg Body Weight|Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
11106119|NCT01620047|BG000|Baseline|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106120|NCT01620047|BG001|Baseline|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106121|NCT01620047|BG002|Baseline|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106122|NCT01620047|BG003|Baseline|Total|Total of all reporting groups
11106123|NCT01620047|FG000|Participant Flow|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106124|NCT01620047|FG001|Participant Flow|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106125|NCT01620047|FG002|Participant Flow|Intravenous Fentanyl|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106126|NCT01620047|OG000|Outcome|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106127|NCT01620047|OG001|Outcome|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106128|NCT01620047|OG002|Outcome|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
10846798|NCT00279955|EG001|Reported Event|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
11106129|NCT01620047|EG000|Reported Event|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106130|NCT01620047|EG001|Reported Event|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106131|NCT01620047|EG002|Reported Event|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
11106132|NCT01620060|BG000|Baseline|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
11106133|NCT01620060|FG000|Participant Flow|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
11106134|NCT01620060|OG000|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
11106135|NCT01620060|EG000|Reported Event|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
11106136|NCT01620086|BG000|Baseline|Patients|Patients with Schizophrenia who meet entry criteria for the study and get stimulation over temporal cortex.
11106137|NCT01620086|BG001|Baseline|Controls|These subjects are normal controls without schizophrenia who get stimulation over the vertex.
11106138|NCT01620086|BG002|Baseline|Total|Total of all reporting groups
11106139|NCT01620086|FG000|Participant Flow|Controls: Baseline, 1Hz Sham, 1 Hz Active Over Vertex|These subjects are normal controls without schizophrenia who receive baseline testing, then sham rTMS, and then active 1Hz rTMS. All stimulation is for two days and delivered over the control site located at the vertex.
11106140|NCT01620086|FG001|Participant Flow|Patients: Baseline, Control Site, & 1Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz located over the control site at the vertex, and then were randomized to receive 1 Hz over the treatment site in temporal cortex before receiving 10 Hz over the treatment site in temporal cortex. All stimulation is delivered for four days.
11106141|NCT01620086|FG002|Participant Flow|Patients: Baseline, Control Site, 10Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz over the control site at the vertex, and then were randomized to receive 10 Hz over the treatment site in temporal cortex before receiving 1 Hz over the treatment site in temporal cortex. All treatment is for four days.
11106142|NCT01620086|OG000|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
11106143|NCT01620086|OG001|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
11106144|NCT01620086|OG002|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
11106145|NCT01620086|OG003|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
11106146|NCT01620086|OG004|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
11106147|NCT01620086|EG000|Reported Event|Patients|These are schizophrenic patients who meet entry criteria for the study.
11106148|NCT01620086|EG001|Reported Event|Controls|These subjects are normal controls without schizophrenia.
11106149|NCT01620138|BG000|Baseline|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated clinically by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
11126585|NCT01734382|OG001|Outcome|Part 2: TCZ IV 12 mg/kg Q3W/Q4W|Participants with weight < 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.
11106150|NCT01620138|BG001|Baseline|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
11106151|NCT01620138|BG002|Baseline|Total|Total of all reporting groups
11106152|NCT01620138|FG000|Participant Flow|Pasireotide|"Non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~Patients with a nonfunctioning pituitary adenoma (NFPA), treatment will be started at least 3 months after neurosurgery. The efficacy will be evaluated by MRI 6 months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After 4 weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for 6 months."
11106153|NCT01620138|FG001|Participant Flow|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
11106154|NCT01620138|OG000|Outcome|Pasireotide|"For non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
11106155|NCT01620138|OG001|Outcome|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
11106156|NCT01620138|EG000|Reported Event|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed immediately before and six months after the onset of pasireotide . The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
11106157|NCT01620138|EG001|Reported Event|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
11106158|NCT01620177|BG000|Baseline|Overall Study|Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated.
11224518|NCT02360475|EG002|Reported Event|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11106159|NCT01620177|FG000|Participant Flow|Overall Study|Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated. There will be six study visits where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals & Clinics) the night before dosing. At each visit subjects will be receive one of the following six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of cannabis.
11106160|NCT01620177|OG000|Outcome|Cannabis - THC|Data from all dosing conditions combined to estimate the effect of THC concentrations using a regression equation.
11106161|NCT01620177|OG001|Outcome|Alcohol - BrAC (Breath Alcohol Concentration)|Data from all dosing conditions combined to estimate the effect of BrACconcentrations using a regression equation.
11106162|NCT01620177|OG002|Outcome|THC x BrAC|Data from all dosing conditions combined to estimate the interactive effect of THC and BrAC concentrations using a regression equation.
11106163|NCT01620177|OG000|Outcome|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106164|NCT01620177|OG001|Outcome|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106165|NCT01620177|OG002|Outcome|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106166|NCT01620177|OG003|Outcome|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106167|NCT01620177|OG004|Outcome|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106168|NCT01620177|OG005|Outcome|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106169|NCT01620177|EG000|Reported Event|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106170|NCT01620177|EG001|Reported Event|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106171|NCT01620177|EG002|Reported Event|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106172|NCT01620177|EG003|Reported Event|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106173|NCT01620177|EG004|Reported Event|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106174|NCT01620177|EG005|Reported Event|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
11106175|NCT01620190|BG000|Baseline|Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11106176|NCT01620190|FG000|Participant Flow|Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11106177|NCT01620190|OG000|Outcome|Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11106178|NCT01620190|EG000|Reported Event|Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11106179|NCT01620216|BG000|Baseline|Group I (Dasatinib)|"Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11106180|NCT01620216|BG001|Baseline|Group II (Sutinib Malate)|"Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sunitinib: Given PO~Sunitinib Malate: Given PO"
11106181|NCT01620216|BG002|Baseline|Group III (Sorafenib Tosylate)|"Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sorafenib: Given PO~Sorafenib Tosylate: Given PO"
11106182|NCT01620216|BG003|Baseline|Group IV (Ponatinib Hydrochloride)|"Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Ponatinib: Given PO~Ponatinib Hydrochloride: Given PO"
11106183|NCT01620216|BG004|Baseline|Group V (Pacritinib)|"Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pacritinib: Given PO~Pharmacological Study: Correlative studies"
11106184|NCT01620216|BG005|Baseline|Group VI (Ruxolitinib)|"Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Ruxolitinib: Given PO"
11106185|NCT01620216|BG006|Baseline|Group VII (Idelalisib)|"Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Idelalisib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11106186|NCT01620216|BG007|Baseline|Total|Total of all reporting groups
11106187|NCT01620216|FG000|Participant Flow|Group I (Dasatinib)|"Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11106188|NCT01620216|FG001|Participant Flow|Group II (Sutinib Malate)|"Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sunitinib: Given PO~Sunitinib Malate: Given PO"
11106189|NCT01620216|FG002|Participant Flow|Group III (Sorafenib Tosylate)|"Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sorafenib: Given PO~Sorafenib Tosylate: Given PO"
11106190|NCT01620216|FG003|Participant Flow|Group IV (Ponatinib Hydrochloride)|"Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Ponatinib: Given PO~Ponatinib Hydrochloride: Given PO"
11106191|NCT01620216|FG004|Participant Flow|Group V (Pacritinib)|"Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pacritinib: Given PO~Pharmacological Study: Correlative studies"
11224519|NCT02360475|EG003|Reported Event|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
11106192|NCT01620216|FG005|Participant Flow|Group VI (Ruxolitinib)|"Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Ruxolitinib: Given PO"
11106193|NCT01620216|FG006|Participant Flow|Group VII (Idelalisib)|"Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Idelalisib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11106194|NCT01620216|OG000|Outcome|Group I (Dasatinib)|"Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11106195|NCT01620216|OG001|Outcome|Group II (Sutinib Malate)|"Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sunitinib: Given PO~Sunitinib Malate: Given PO"
11106196|NCT01620216|OG002|Outcome|Group III (Sorafenib Tosylate)|"Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sorafenib: Given PO~Sorafenib Tosylate: Given PO"
11106197|NCT01620216|OG003|Outcome|Group IV (Ponatinib Hydrochloride)|"Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Ponatinib: Given PO~Ponatinib Hydrochloride: Given PO"
11106198|NCT01620216|OG004|Outcome|Group V (Pacritinib)|"Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pacritinib: Given PO~Pharmacological Study: Correlative studies"
11106199|NCT01620216|OG005|Outcome|Group VI (Ruxolitinib)|"Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Ruxolitinib: Given PO"
11106200|NCT01620216|OG006|Outcome|Group VII (Idelalisib)|"Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Idelalisib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11106201|NCT01620216|EG000|Reported Event|Group I (Dasatinib)|"Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11106202|NCT01620216|EG001|Reported Event|Group II (Sunitinib Malate)|"Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sunitinib: Given PO~Sunitinib Malate: Given PO"
11106203|NCT01620216|EG002|Reported Event|Group III (Sorafenib Tosylate)|"Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sorafenib: Given PO~Sorafenib Tosylate: Given PO"
11106204|NCT01620216|EG003|Reported Event|Group IV (Ponatinib Hydrochloride)|"Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Ponatinib: Given PO~Ponatinib Hydrochloride: Given PO"
11106205|NCT01620216|EG004|Reported Event|Group V (Pacritinib)|"Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pacritinib: Given PO~Pharmacological Study: Correlative studies"
11106206|NCT01620216|EG005|Reported Event|Group VI (Ruxolitinib)|"Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Ruxolitinib: Given PO"
11106207|NCT01620216|EG006|Reported Event|Group VII (Idelalisib)|"Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening~Idelalisib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11106208|NCT01620255|BG000|Baseline|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106209|NCT01620255|BG001|Baseline|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106210|NCT01620255|BG002|Baseline|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106211|NCT01620255|BG003|Baseline|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106212|NCT01620255|BG004|Baseline|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106213|NCT01620255|BG005|Baseline|Total|Total of all reporting groups
11106214|NCT01620255|FG000|Participant Flow|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106215|NCT01620255|FG001|Participant Flow|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106216|NCT01620255|FG002|Participant Flow|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106217|NCT01620255|FG003|Participant Flow|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106218|NCT01620255|FG004|Participant Flow|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106219|NCT01620255|OG000|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106220|NCT01620255|OG001|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106221|NCT01620255|OG002|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106222|NCT01620255|OG003|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106223|NCT01620255|OG004|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11336505|NCT03567291|FG000|Participant Flow|TEV-50717|All participants underwent TEV-50717 dose titration in this study. They received 6 mg of TEV-50717 with food on the evening of day 1. The titration scheme and maximum dose were determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study.
11106224|NCT01620255|EG000|Reported Event|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106225|NCT01620255|EG001|Reported Event|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106226|NCT01620255|EG002|Reported Event|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106227|NCT01620255|EG003|Reported Event|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106228|NCT01620255|EG004|Reported Event|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
11106229|NCT01620489|BG000|Baseline|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
11106230|NCT01620489|BG001|Baseline|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
11106231|NCT01620489|BG002|Baseline|Total|Total of all reporting groups
11106232|NCT01620489|FG000|Participant Flow|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
11106233|NCT01620489|FG001|Participant Flow|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
11106234|NCT01620489|OG000|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
11106235|NCT01620489|OG001|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
11106236|NCT01620489|EG000|Reported Event|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
11106237|NCT01620489|EG001|Reported Event|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
11106238|NCT01620528|BG000|Baseline|Placebo|Placebo BID for the 6-month Treatment Period
11106239|NCT01620528|BG001|Baseline|Elagolix 150 mg QD|Elagolix 150 mg QD for the 6-month Treatment Period
11106240|NCT01620528|BG002|Baseline|Elagolix 200 mg BID|Elagolix 200 mg BID for the 6-month Treatment Period
10846799|NCT00279955|EG002|Reported Event|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
11106241|NCT01620528|BG003|Baseline|Total|Total of all reporting groups
11106242|NCT01620528|FG000|Participant Flow|Placebo|Placebo twice daily (BID) for the 6-month Treatment Period
11106243|NCT01620528|FG001|Participant Flow|Elagolix 150 mg QD|Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
11106244|NCT01620528|FG002|Participant Flow|Elagolix 200 mg BID|Elagolix 200 mg BID for the 6-month Treatment Period
11106245|NCT01620528|OG000|Outcome|Placebo|Placebo BID for the 6-month Treatment Period
11106246|NCT01620528|OG001|Outcome|Elagolix 150 mg QD|Elagolix 150 mg QD for the 6-month Treatment Period
11106247|NCT01620528|OG002|Outcome|Elagolix 200 mg BID|Elagolix 200 mg BID for the 6-month Treatment Period
11106248|NCT01620528|EG000|Reported Event|Placebo|Placebo BID for the 6-month Treatment Period
11106249|NCT01620528|EG001|Reported Event|Elagolix 150 MG QD|Elagolix 150 mg QD for the 6-month Treatment Period
11106250|NCT01620528|EG002|Reported Event|Elagolix 200 MG BID|Elagolix 200 mg BID for the 6-month Treatment Period
11106251|NCT01620567|BG000|Baseline|Chickpeas/Potatoes|1 cup chickpeas/potatoes for 6 months
11106252|NCT01620567|BG001|Baseline|Avocados|1 avocado/day for 6 months
11106253|NCT01620567|BG002|Baseline|Total|Total of all reporting groups
11106254|NCT01620567|FG000|Participant Flow|Chickpeas/Potatoes|1 cup of chickpeas/potatoes for 6 months
11106255|NCT01620567|FG001|Participant Flow|Avocados|1 avocado/day for 6 months
11106256|NCT01620567|OG000|Outcome|Chickpeas/Potatoes|1 potato/day or 1 cup chickpeas for 6 months
11106257|NCT01620567|OG001|Outcome|Avocados|1 avocado/day for 6 months
11106258|NCT01620567|OG000|Outcome|Chickpeas/Potatoes|"1 potato/day or 1 cup chickpeas~potato or chickpea: 1 cup potatoes or chickpeas/day for 6 months"
11106259|NCT01620567|OG001|Outcome|Avocados|"1 avocados/day~avocado: 1 avocado/day for 6 months"
11106260|NCT01620567|OG000|Outcome|Chickpeas/Potatoes|1 cup of chickpeas/potatoes for 6 months
11106261|NCT01620567|EG000|Reported Event|Chickpeas/Potatoes|1 cup chickpeas/potatoes for 6 months
11106262|NCT01620567|EG001|Reported Event|Avocados|"avocados~1 avocado/day for 6 months"
11106263|NCT01620593|BG000|Baseline|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
11106264|NCT01620593|BG001|Baseline|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
11106265|NCT01620593|BG002|Baseline|Total|Total of all reporting groups
11106266|NCT01620593|FG000|Participant Flow|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
11106267|NCT01620593|FG001|Participant Flow|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
11106268|NCT01620593|OG000|Outcome|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
11106269|NCT01620593|OG001|Outcome|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
11106270|NCT01620593|EG000|Reported Event|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
11106271|NCT01620593|EG001|Reported Event|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
11106272|NCT01620762|BG000|Baseline|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
11106273|NCT01620762|BG001|Baseline|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
11106274|NCT01620762|BG002|Baseline|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
11106275|NCT01620762|BG003|Baseline|Total|Total of all reporting groups
11106276|NCT01620762|FG000|Participant Flow|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
11106277|NCT01620762|FG001|Participant Flow|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
11106278|NCT01620762|FG002|Participant Flow|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
11106279|NCT01620762|OG000|Outcome|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
11106280|NCT01620762|OG001|Outcome|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
11106281|NCT01620762|OG002|Outcome|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
11106282|NCT01620762|EG000|Reported Event|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
11106283|NCT01620762|EG001|Reported Event|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
11106284|NCT01620762|EG002|Reported Event|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
11106285|NCT01620983|BG000|Baseline|Pain Coping Skills Training|"The pain coping skills training will be delivered by physical therapists in eight one-hour sessions by telephone over a 2-month perioperative period. Patients will be taught a variety of skills designed to improve maladaptive pain related thoughts and actions to enhance recovery following arthroplasty.~Pain Coping Skills Training"
11106286|NCT01620983|BG001|Baseline|Arthritis Education|"The eight one-hour perioperative arthritis education sessions will be delivered by nurse educators via telephone and will use a presentation and discussion format. Figures and discussion sessions will present information on the nature of arthritis, what to expect following knee arthroplasty, treatment of osteoarthritis, the role of exercise, joint protection and making future treatment decisions.~Arthritis Education"
11106287|NCT01620983|BG002|Baseline|Usual Care|"Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.~Usual Care"
11106288|NCT01620983|BG003|Baseline|Total|Total of all reporting groups
11106289|NCT01620983|FG000|Participant Flow|Pain Coping Skills Training|"The pain coping skills training will be delivered by physical therapists in eight one-hour sessions by telephone over a 2-month perioperative period. Patients will be taught a variety of skills designed to improve maladaptive pain related thoughts and actions to enhance recovery following arthroplasty.~Pain Coping Skills Training"
11106290|NCT01620983|FG001|Participant Flow|Arthritis Education|"The eight one-hour perioperative arthritis education sessions will be delivered by nurse educators via telephone and will use a presentation and discussion format. Figures and discussion sessions will present information on the nature of arthritis, what to expect following knee arthroplasty, treatment of osteoarthritis, the role of exercise, joint protection and making future treatment decisions.~Arthritis Education"
11106291|NCT01620983|FG002|Participant Flow|Usual Care|"Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.~Usual Care"
11106292|NCT01620983|OG000|Outcome|Pain Coping Skills Training|"The pain coping skills training will be delivered by physical therapists in eight one-hour sessions by telephone over a 2-month perioperative period. Patients will be taught a variety of skills designed to improve maladaptive pain related thoughts and actions to enhance recovery following arthroplasty.~Pain Coping Skills Training"
11106293|NCT01620983|OG001|Outcome|Arthritis Education|"The eight one-hour perioperative arthritis education sessions will be delivered by nurse educators via telephone and will use a presentation and discussion format. Figures and discussion sessions will present information on the nature of arthritis, what to expect following knee arthroplasty, treatment of osteoarthritis, the role of exercise, joint protection and making future treatment decisions.~Arthritis Education"
11106294|NCT01620983|OG002|Outcome|Usual Care|"Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.~Usual Care"
11106295|NCT01620983|EG000|Reported Event|Pain Coping Skills Training|"The pain coping skills training will be delivered by physical therapists in eight one-hour sessions by telephone over a 2-month perioperative period. Patients will be taught a variety of skills designed to improve maladaptive pain related thoughts and actions to enhance recovery following arthroplasty.~Pain Coping Skills Training"
11106296|NCT01620983|EG001|Reported Event|Arthritis Education|"The eight one-hour perioperative arthritis education sessions will be delivered by nurse educators via telephone and will use a presentation and discussion format. Figures and discussion sessions will present information on the nature of arthritis, what to expect following knee arthroplasty, treatment of osteoarthritis, the role of exercise, joint protection and making future treatment decisions.~Arthritis Education"
11106297|NCT01620983|EG002|Reported Event|Usual Care|"Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.~Usual Care"
11106298|NCT01621009|BG000|Baseline|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
11106299|NCT01621009|BG001|Baseline|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
11106300|NCT01621009|BG002|Baseline|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
11106301|NCT01621009|BG003|Baseline|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
11106302|NCT01621009|BG004|Baseline|Total|Total of all reporting groups
11106303|NCT01621009|FG000|Participant Flow|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
11106304|NCT01621009|FG001|Participant Flow|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
11106305|NCT01621009|FG002|Participant Flow|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
11106306|NCT01621009|FG003|Participant Flow|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
11106307|NCT01621009|OG000|Outcome|Bupropion + Counseling|"Active bupropion + 8 weeks counseling: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.~Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
11106308|NCT01621009|OG001|Outcome|Bupropion, No Counseling|Active bupropion, No counseling: Medications: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only.
11106309|NCT01621009|OG002|Outcome|Placebo + Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.~Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
11106310|NCT01621009|OG003|Outcome|Placebo, No Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.~No cessation counseling, medication management and assessment only."
11106311|NCT01621009|EG000|Reported Event|Placebo Medication|Medications: Pre-quit - one placebo pill for 3 days before quit day, then one placebo pill twice a day 4 days before quit day for 8 weeks after the quit date.
11106312|NCT01621009|EG001|Reported Event|Active Medication|Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.
11106313|NCT01621126|BG000|Baseline|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
11106314|NCT01621126|FG000|Participant Flow|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
11106315|NCT01621126|OG000|Outcome|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
11106316|NCT01621126|EG000|Reported Event|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
11106317|NCT01621178|BG000|Baseline|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106318|NCT01621178|BG001|Baseline|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106319|NCT01621178|BG002|Baseline|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106320|NCT01621178|BG003|Baseline|Total|Total of all reporting groups
11106321|NCT01621178|FG000|Participant Flow|Insulin Glargine|Insulin glargine was administered subcutaneously (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106322|NCT01621178|FG001|Participant Flow|0.75 mg Dulaglutide|0.75 milligram (mg) of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106323|NCT01621178|FG002|Participant Flow|1.5 mg Dulaglutide|1.5 mg of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106324|NCT01621178|OG000|Outcome|Insulin Glargine|Insulin glargine was administered subcutaneous (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106325|NCT01621178|OG001|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106326|NCT01621178|OG002|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106327|NCT01621178|OG000|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106328|NCT01621178|OG000|Outcome|Insulin Glargine|Insulin glargine administered SC to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106329|NCT01621178|OG001|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106330|NCT01621178|OG002|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106331|NCT01621178|EG000|Reported Event|Insulin Glargine|Insulin glargine administered SC to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106332|NCT01621178|EG001|Reported Event|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106333|NCT01621178|EG002|Reported Event|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
11106334|NCT01621191|BG000|Baseline|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
11106335|NCT01621191|FG000|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to a 60-milligram (mg) dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
11106336|NCT01621191|OG000|Outcome|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
11106337|NCT01621191|OG000|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
10878605|NCT00453362|FG000|Participant Flow|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET (2-deoxy-2-[18F]fluoro-D-glucose-Positron Emission Tomogrpahy)and FLT-PET (3'-deoxy-3'-[18F]fluorothymidine-Positron Emission Tomogrpahy) scans.~FDG-PET intravenous injection dosage was based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose was 7 mCi."
10878606|NCT00453362|OG000|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
10878607|NCT00453362|OG001|Outcome|Erlotinib_ FDG Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
10878608|NCT00453362|OG000|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi."
11106338|NCT01621191|EG000|Reported Event|60 mg Duloxetine|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
11106339|NCT01621230|BG000|Baseline|Bupivacaine Plus Fentanyl|Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.
11106340|NCT01621230|BG001|Baseline|Fentanyl Only|Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.
11106341|NCT01621230|BG002|Baseline|Total|Total of all reporting groups
11106342|NCT01621230|FG000|Participant Flow|Bupivacaine Plus Fentanyl|Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.
11106343|NCT01621230|FG001|Participant Flow|Fentanyl Only|Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.
11004426|NCT01076543|OG001|Outcome|Phase I, All Histologies, Lenalidomide 20 mg|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004427|NCT01076543|OG002|Outcome|Phase I, All Histologies, Lenalidomide 25 mg|Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004428|NCT01076543|OG003|Outcome|Phase II, Diffuse Large B-Cell Subtype|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004429|NCT01076543|OG004|Outcome|Phase II, Follicular Subtype|Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004430|NCT01076543|OG005|Outcome|Phase II, Lymphoma NOS|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004431|NCT01076543|OG000|Outcome|Phase I, All Histologies, Lenalidomide 15 mg|Patients receive lenalidomide 15 mg PO on days 1-21 and25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004432|NCT01076543|EG000|Reported Event|Phase I, All Histologies, Lenalidomide 15 mg|Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004433|NCT01076543|EG001|Reported Event|Phase I, All Histologies, Lenalidomide 20 mg|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004434|NCT01076543|EG002|Reported Event|Phase I, All Histologies, Lenalidomide 25 mg|Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004435|NCT01076543|EG003|Reported Event|Phase II, Diffuse Large B-Cell Subtype|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004436|NCT01076543|EG004|Reported Event|Phase II, Follicular Subtype|Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004437|NCT01076543|EG005|Reported Event|Phase II, Lymphoma NOS|Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
11004438|NCT01076647|BG000|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
11004439|NCT01076647|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
11004440|NCT01076647|BG002|Baseline|Total|Total of all reporting groups
11004441|NCT01076647|FG000|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
11004442|NCT01076647|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
11004443|NCT01076647|OG000|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
11004444|NCT01076647|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
11004445|NCT01076647|EG000|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
11004446|NCT01076647|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
11004447|NCT01076686|BG000|Baseline|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004448|NCT01076686|BG001|Baseline|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004449|NCT01076686|BG002|Baseline|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
11004450|NCT01076686|BG003|Baseline|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004451|NCT01076686|BG004|Baseline|Total|Total of all reporting groups
11004452|NCT01076686|FG000|Participant Flow|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004453|NCT01076686|FG001|Participant Flow|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004454|NCT01076686|FG002|Participant Flow|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
11004455|NCT01076686|FG003|Participant Flow|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004456|NCT01076686|OG000|Outcome|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11106344|NCT01621230|OG000|Outcome|Group I (Bupivacaine)|Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.
11004457|NCT01076686|OG001|Outcome|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004458|NCT01076686|OG002|Outcome|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
11004459|NCT01076686|OG003|Outcome|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004460|NCT01076686|EG000|Reported Event|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004461|NCT01076686|EG001|Reported Event|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004462|NCT01076686|EG002|Reported Event|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
11004463|NCT01076686|EG003|Reported Event|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
11004464|NCT01076959|BG000|Baseline|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
11004465|NCT01076959|FG000|Participant Flow|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
11004466|NCT01076959|OG000|Outcome|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
11004467|NCT01076959|OG000|Outcome|Physician Response Rating|The full analysis set was used to determine the physicians' overall response rating.
11004468|NCT01076959|OG000|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response according to DAS 28 (improvement > 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
11004469|NCT01076959|OG001|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
11004470|NCT01076959|OG002|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement <0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
11004471|NCT01076959|OG003|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
11004472|NCT01076959|OG000|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
11004473|NCT01076959|OG001|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
11004474|NCT01076959|OG002|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
11004475|NCT01076959|OG003|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
11004476|NCT01076959|OG000|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 4.at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
11004477|NCT01076959|OG001|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
11004478|NCT01076959|OG002|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
11004479|NCT01076959|OG003|Outcome|Effective Rate-Sum of Patients With Good and Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
11004480|NCT01076959|EG000|Reported Event|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
11004481|NCT01076972|BG000|Baseline|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
11004482|NCT01076972|FG000|Participant Flow|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
11004483|NCT01076972|OG000|Outcome|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
11004484|NCT01076972|OG000|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
11004485|NCT01076972|OG001|Outcome|Lopinavir/Ritonavir: Treatment-Experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
11106345|NCT01621230|OG001|Outcome|Group II (No Bupivacaine)|Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.
11106346|NCT01621230|OG000|Outcome|Epidural Bupivacaine Plus Fentanyl (Bupivacaine)|"A continuous epidural infusion of bupivacaine plus fentanyl during the second stage (i.e. 10 cm dilation) of labor. Epidural infusion are 10 ml/hr basal infusion plus 5 ml/hr demand dose via patient-controlled epidural analgesia (PCEA). Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed .~Epidural Bupivacaine plus fentanyl: The subjects will receive 0.125% bupivacaine with fentanyl 2 mcg/mL at a rate of 10 mL/hr."
11106347|NCT01621230|OG000|Outcome|Epidural Fentanyl|"A continuous epidural infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 ml/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 mL/hr for pain. Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed.~Epidural fentanyl: The subjects will receive epidural fentanyl 10 mcg/mL with the rate of 10mL/hr."
11106348|NCT01621230|OG001|Outcome|Epidural Bupivacaine Plus Fentanyl (Bupivacaine)|"A continuous epidural infusion of bupivacaine plus fentanyl during the second stage (i.e. 10 cm dilation) of labor. Epidural infusion are 10 ml/hr basal infusion plus 5 ml/hr demand dose via patient-controlled epidural analgesia (PCEA). Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed .~Epidural Bupivacaine plus fentanyl: The subjects will receive 0.125% bupivacaine with fentanyl 2 mcg/mL at a rate of 10 mL/hr."
11106349|NCT01621230|EG000|Reported Event|Bupivacaine Plus Fentanyl|A continuous epidural infusion of bupivacaine plus fentanyl during the second stage (i.e. 10 cm dilation) of labor at a rate of 10 ml/hr basal infusion plus 5 ml/hr demand dose via patient-controlled epidural analgesia (PCEA). Subjects were allowed to receive intravenous meperidine 25 mg for breakthrough pain as needed.
11106350|NCT01621230|EG001|Reported Event|Fentanyl Alone|A continuous infusion of fentanyl 10 mcg/mL at a basal infusion rate of 10 ml/hr. and a demand dose of 5 ml/hr for pain. Subjects received intravenous meperidine 25 mg for breakthrough pain as needed.
11106351|NCT01621477|BG000|Baseline|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
11106352|NCT01621477|FG000|Participant Flow|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
10846800|NCT00280059|BG000|Baseline|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
11106353|NCT01621477|OG000|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
11106354|NCT01621477|EG000|Reported Event|Treatment|Study participants (excluding donors) who were enrolled to receive treatment with clofarabine, cytarabine, busulfan, plerixafor, cyclophosphamide, antithymocyte globulin (rabbit), stem cells, tacrolimus, and mycophenolate mofetil. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
11106355|NCT01621490|BG000|Baseline|N3 60 M Naive|Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; 30M = 30 minute infusion; NAIVE = Anti-CTLA4 Naive
11106356|NCT01621490|BG001|Baseline|N3 60M Prog|Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed;
11106357|NCT01621490|BG002|Baseline|N1 60M + I3 90M, W2|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W2 = Week 2 Biopsy
11106358|NCT01621490|BG003|Baseline|N1 60M + I3 90M, W4|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W4 = Week 4 Biopsy
11106359|NCT01621490|BG004|Baseline|N1 60M +I3 90M, WU|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; WU = Unknown Week Biopsy;
11106360|NCT01621490|BG005|Baseline|N1 30M + I3 30M Non-BM|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106361|NCT01621490|BG006|Baseline|N3 30M Non-BM|Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases
11106362|NCT01621490|BG007|Baseline|N1 30M +I3 30M BM|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106363|NCT01621490|BG008|Baseline|N3 30M BM|Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106364|NCT01621490|BG009|Baseline|Total|Total of all reporting groups
11106365|NCT01621490|FG000|Participant Flow|N3 60 M Naive|Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; 30M = 30 minute infusion; NAIVE = Anti-CTLA4 Naive
11106366|NCT01621490|FG001|Participant Flow|N3 60M Prog|Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed
11106367|NCT01621490|FG002|Participant Flow|N1 60M + I3 90M, W2|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W2 = Week 2 Biopsy
11106368|NCT01621490|FG003|Participant Flow|N1 60M + I3 90M, W4|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W4 = Week 4 Biopsy
11106369|NCT01621490|FG004|Participant Flow|N1 60M +I3 90M, WU|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; WU = Unknown Week Biopsy;
11106370|NCT01621490|FG005|Participant Flow|N1 30M + I3 30M Non-BM|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106371|NCT01621490|FG006|Participant Flow|N3 30M Non-BM|Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases
11106372|NCT01621490|FG007|Participant Flow|N1 30M +I3 30M BM|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106373|NCT01621490|FG008|Participant Flow|N3 30M BM|Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106374|NCT01621490|OG000|Outcome|N3 60M Naive|Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive
11004486|NCT01076972|OG001|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 418 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
11004487|NCT01076972|OG000|Outcome|Lopinavir/Ritonavir: Baseline Category A|The subgroup of patients who were classified as CDC Category A at Baseline (prior to treatment with lopinavir/ritonavir).
11004488|NCT01076972|OG001|Outcome|Lopinavir/Ritonavir: Baseline Category B|The subgroup of participants who were classified as CDC Category B at Baseline (prior to treatment with lopinavir/ritonavir).
11004489|NCT01076972|OG002|Outcome|Lopinavir/Ritonavir: Baseline Category C|The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).
11004490|NCT01076972|OG003|Outcome|Lopinavir/Ritonavir: Baseline Category P-0|The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).
11004491|NCT01076972|OG004|Outcome|Lopinavir/Ritonavir: Baseline Category P-1|The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).
11004492|NCT01076972|OG005|Outcome|Lopinavir/Ritonavir: Baseline Category P-2|The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).
11004493|NCT01076972|OG006|Outcome|Lopinavir/Ritonavir: Baseline Category Unknown|The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
11004494|NCT01076972|EG000|Reported Event|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
11004495|NCT01076985|BG000|Baseline|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
11004496|NCT01076985|FG000|Participant Flow|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
11004497|NCT01076985|OG000|Outcome|Lopinavir/Ritonavir|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
11004498|NCT01076985|OG001|Outcome|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection and participated in this noninterventional, post-marketing observational study.
11004499|NCT01076985|EG000|Reported Event|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
11004500|NCT01076985|EG001|Reported Event|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.
11106375|NCT01621490|OG001|Outcome|N3 60M PROG|Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Progressed
11004501|NCT01077024|BG000|Baseline|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
11004502|NCT01077024|BG001|Baseline|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
11004503|NCT01077024|BG002|Baseline|Total|Total of all reporting groups
11004504|NCT01077024|FG000|Participant Flow|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
11004505|NCT01077024|FG001|Participant Flow|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
11004506|NCT01077024|OG000|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
11004507|NCT01077024|OG001|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
11004508|NCT01077024|EG000|Reported Event|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
11004509|NCT01077024|EG001|Reported Event|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
11004510|NCT01077050|BG000|Baseline|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
11004511|NCT01077050|FG000|Participant Flow|Only One Arm in the Study, Thus Not Applicable.|
11004512|NCT01077050|OG000|Outcome|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
11004513|NCT01077050|EG000|Reported Event|Biopsied Skin Lesions|"Any adverse advent that occured on a skin/lesion site for whom there had been any contact between the subject's skin and investigational device (SciBase III).~Note that multiple adverse event occured on some subjects. In total 36 Adverse Events were reported on 28 subjects."
11004514|NCT01077063|BG000|Baseline|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
11004515|NCT01077063|BG001|Baseline|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
11004516|NCT01077063|BG002|Baseline|Total|Total of all reporting groups
11004517|NCT01077063|FG000|Participant Flow|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
11004518|NCT01077063|FG001|Participant Flow|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
11004519|NCT01077063|OG000|Outcome|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
11004520|NCT01077063|OG001|Outcome|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
11004521|NCT01077063|EG000|Reported Event|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
11004522|NCT01077063|EG001|Reported Event|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
11004523|NCT01077076|BG000|Baseline|Entire Study Population|
11004524|NCT01077076|FG000|Participant Flow|Zegerid/Prilosec/Placebo|Participants received Zegerid over-the-counter (OTC) Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
11004525|NCT01077076|FG001|Participant Flow|Zegerid/Placebo/Prilosec|Participants received Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
11004526|NCT01077076|FG002|Participant Flow|Prilosec/Zegerid/Placebo|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
11004527|NCT01077076|FG003|Participant Flow|Prilosec/Placebo/Zegerid|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
11004528|NCT01077076|FG004|Participant Flow|Placebo/Zegerid/Prilosec|Participants received Placebo Capsules in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
11004529|NCT01077076|FG005|Participant Flow|Placebo/Prilosec/Zegerid|Participants received Placebo Capsules in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
11004530|NCT01077076|OG000|Outcome|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
11004531|NCT01077076|OG001|Outcome|Prilosec OTC Tablets|20 mg-equivalent omeprazole
11004532|NCT01077076|OG002|Outcome|Placebo Capsules|
11004533|NCT01077076|EG000|Reported Event|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
11004534|NCT01077076|EG001|Reported Event|Prilosec OTC Tablets|20 mg-equivalent omeprazole
11004535|NCT01077076|EG002|Reported Event|Placebo Capsules|
11004536|NCT01077128|BG000|Baseline|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
11004537|NCT01077128|FG000|Participant Flow|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
11004538|NCT01077128|OG000|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
11004539|NCT01077128|OG001|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
11004540|NCT01077128|OG002|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
11004541|NCT01077128|OG003|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
11004542|NCT01077128|OG000|Outcome|DLQI Score Change by PGA Response Group- Month 1|All eligible patients with psoriasis treated with Adalimumab
11004543|NCT01077128|OG001|Outcome|DLQI Score Change by PGA Response Group- Month 4|All eligible patients with psoriasis treated with Adalimumab
11004544|NCT01077128|OG002|Outcome|DLQI Score Change by PGA Response Group- Month 8|All eligible patients with psoriasis treated with Adalimumab
11004545|NCT01077128|OG003|Outcome|DLQI Score Change by PGA Response Group- Month 12|All eligible patients with psoriasis treated with Adalimumab
11004546|NCT01077128|OG004|Outcome|DLQI Score Change Baseline to Month 12- Attica|All eligible patients with psoriasis treated with Adalimumab
11004547|NCT01077128|OG005|Outcome|DLQI Score Change Baseline to Month 12- Central Greece|All eligible patients with psoriasis treated with Adalimumab
11004548|NCT01077128|OG006|Outcome|DLQI Score Change Baseline to Month 12- Central Macedonia|All eligible patients with psoriasis treated with Adalimumab
11004549|NCT01077128|OG007|Outcome|DLQI Score Change Baseline to Month 12- Crete|All eligible patients with psoriasis treated with Adalimumab
11004550|NCT01077128|OG008|Outcome|DLQI Score Change Baseline to Month 12- East Macedonia/Thrace|All eligible patients with psoriasis treated with Adalimumab
11004551|NCT01077128|OG009|Outcome|DLQI Score Change Baseline to Month 12- Epirus|All eligible patients with psoriasis treated with Adalimumab
11106376|NCT01621490|OG002|Outcome|N1 60M + I3 90M|Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute
11106377|NCT01621490|OG003|Outcome|N1 30M + I3 30M Non-BM|Treatment Group: Part 3: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106378|NCT01621490|OG004|Outcome|N3 30M Non-BM|Treatment Group: Part 3: Nivolumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106379|NCT01621490|OG005|Outcome|N1 30M + I3 30M BM|Treatment Group: Part 4: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106380|NCT01621490|OG006|Outcome|N3 30M BM|Treatment Group: Part 4: Nivolumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106381|NCT01621490|OG007|Outcome|N1+ I3 Non-BM|Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases
11106382|NCT01621490|OG008|Outcome|Naive Nivo Mono|Nivolumab Monotherapy CTLA-4 Naive
11106383|NCT01621490|OG009|Outcome|All Nivo|Treatment Group: All Nivolumab Monotherapy
11106384|NCT01621490|OG010|Outcome|All Combo|Treatment Group: All Combination Therapy
11106385|NCT01621490|OG011|Outcome|Total|All treatments
11106386|NCT01621490|OG002|Outcome|N1 60M + I3 90M W2|Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute Infusion Week 2 Biopsy
11106387|NCT01621490|OG003|Outcome|N1 60M + I3 90M W4|Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute Infusion Week 4 Biopsy
11106388|NCT01621490|OG004|Outcome|N1 30M + I3 30M Non-BM|Treatment Group: Part 3: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106389|NCT01621490|OG005|Outcome|N3 30M Non-BM|Treatment Group: Part 3: Nivolumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106390|NCT01621490|OG006|Outcome|N3 30M + I3 30M BM|Treatment Group: Part 4: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106391|NCT01621490|OG007|Outcome|N3 30M BM|Treatment Group: Part 4: Nivolumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106392|NCT01621490|OG008|Outcome|Nivo Mono|Treatment Group: Part 1: Regular Infusion Nivolumab Mono
11106393|NCT01621490|OG009|Outcome|Nivo Mono Reduced Infusion|Treatment Group: Reduced Infusion Nivolumab Monotherapy
11106394|NCT01621490|OG010|Outcome|Week 2 Biopsy Combo|Treatment Group: Week 2 Biopsy Combo
11106395|NCT01621490|OG011|Outcome|Week 2 Biopsy Non-BM Combo|Treatment Group: Week 2 Biopsy Non-Brain Metastases Combo
11106396|NCT01621490|OG012|Outcome|Naive Nivo Mono Non-BM|Treatment Group: Naive Nivolumab Mono Non-Brain Metastases
11106397|NCT01621490|OG013|Outcome|N1 + I3 Non-BM|Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases
11106398|NCT01621490|OG000|Outcome|N3 60M Naive|N3 = Nivolumab 3mg/kg;60M = 60 minute infusion; NAIVE = Anti-CTLA4 Naive
11106399|NCT01621490|OG001|Outcome|N3 60M PROG|N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion;PROG = Anti-CTLA4 Progressed
11106400|NCT01621490|OG002|Outcome|N1 60M + I3 90M|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion
11106401|NCT01621490|OG003|Outcome|N1 30M + I3 30M Non-BM|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106402|NCT01621490|OG004|Outcome|N3 30M Non-BM|N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106403|NCT01621490|OG005|Outcome|N1 30M + I3 30M BM|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106404|NCT01621490|OG006|Outcome|N3 30M BM|N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106405|NCT01621490|OG007|Outcome|N3 60M|N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion
11106406|NCT01621490|OG008|Outcome|N3 30M|N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion
11106407|NCT01621490|OG009|Outcome|N1 30M + I3 30M|N3 = Nivolumab 3mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion
11106408|NCT01621490|OG010|Outcome|N3 NAIVE|N3 = Nivolumab 3mg/kg; NAIVE = Anti-CTLA4 Naive
11106409|NCT01621490|OG011|Outcome|All N3|N3 = Nivolumab 3mg/kg
11106410|NCT01621490|OG012|Outcome|Total|All treatments
11106411|NCT01621490|OG000|Outcome|N3 60M Naive|Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive
11106412|NCT01621490|OG001|Outcome|N3 60M Prog|Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Progressed
11106413|NCT01621490|OG002|Outcome|N1 60M + I3 90M|Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute Infusion
11106414|NCT01621490|OG003|Outcome|N1 30M + I3 30M Non-BM|Part 3: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106415|NCT01621490|OG004|Outcome|N3 30M Non-BM|Part 3: Nivolumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106416|NCT01621490|OG005|Outcome|N1 30M I3 30M BM|Part 4: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106417|NCT01621490|OG006|Outcome|N3 30M BM|Part 4: Nivolumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106418|NCT01621490|OG007|Outcome|Nivo Mono|Part 1: Regular Infusion Nivolumab Mono
11106419|NCT01621490|OG008|Outcome|Reduced Nivo Mono|Reduced Infusion Nivolumab Mono
11106420|NCT01621490|OG009|Outcome|Reduced Combo|Reduced Infusion Combo
11106421|NCT01621490|OG010|Outcome|Naive Nivo Mono|Naive Nivolumab Mono
11106422|NCT01621490|OG011|Outcome|All Nivo Mono|All Nivolumab Mono
11106423|NCT01621490|OG012|Outcome|All Combo|All Combinations
11106424|NCT01621490|OG013|Outcome|Total|All treatments
11106425|NCT01621490|OG000|Outcome|N3 60M NAIVE|Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; NAIVE = Anti-CTLA4 Naive
11106426|NCT01621490|OG002|Outcome|N1 60M +I3 90M|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion
11106427|NCT01621490|OG003|Outcome|N1 30M + I3 30M Non-BM|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106428|NCT01621490|OG004|Outcome|N3 30M Non-BM|Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases;
11106429|NCT01621490|OG005|Outcome|N1 30M + I3 30M BM|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg;30M = 30 minute infusion; BM = Brain metastases
11106430|NCT01621490|OG008|Outcome|N3 30M|N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion
11106431|NCT01621490|OG009|Outcome|N1 30M + I3 30M|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion
11004552|NCT01077128|OG010|Outcome|DLQI Score Change Baseline to Month 12- Ionian Islands|All eligible patients with psoriasis treated with Adalimumab
11004553|NCT01077128|OG011|Outcome|DLQI Score Change Baseline to Month 12- North Aegean|All eligible patients with psoriasis treated with Adalimumab
11004554|NCT01077128|OG012|Outcome|DLQI Score Change Baseline to Month 12- Peloponnese|All eligible patients with psoriasis treated with Adalimumab
11004555|NCT01077128|OG013|Outcome|DLQI Score Change Baseline to Month 12- South Aegean|All eligible patients with psoriasis treated with Adalimumab
11004556|NCT01077128|OG014|Outcome|DLQI Score Change Baseline to Month 12- Thessaly|All eligible patients with psoriasis treated with Adalimumab
11004557|NCT01077128|OG015|Outcome|DLQI Score Change Baseline to Month 12- West Greece|All eligible patients with psoriasis treated with Adalimumab
11004558|NCT01077128|OG016|Outcome|DLQI Score Change Baseline to Month 12- West Macedonia|All eligible patients with psoriasis treated with Adalimumab
11004559|NCT01077128|OG000|Outcome|EQ5D- Mobility- Baseline|All eligible patients with psoriasis treated with Adalimumab
11004560|NCT01077128|OG001|Outcome|EQ5D- Mobility- Month 1|All eligible patients with psoriasis treated with Adalimumab
11004561|NCT01077128|OG002|Outcome|EQ5D- Mobility- Month 4|All eligible patients with psoriasis treated with Adalimumab
11004562|NCT01077128|OG003|Outcome|EQ5D- Mobility- Month 8|All eligible patients with psoriasis treated with Adalimumab
11004563|NCT01077128|OG004|Outcome|EQ5D- Mobility- Month 12|All eligible patients with psoriasis treated with Adalimumab
11004564|NCT01077128|OG005|Outcome|EQ5D- Self-care- Baseline|All eligible patients with psoriasis treated with Adalimumab
11004565|NCT01077128|OG006|Outcome|EQ5D- Self-care- Month 1|All eligible patients with psoriasis treated with Adalimumab
11004566|NCT01077128|OG007|Outcome|EQ5D- Self-care- Month 4|All eligible patients with psoriasis treated with Adalimumab
11004567|NCT01077128|OG008|Outcome|EQ5D- Self-care- Month 8|All eligible patients with psoriasis treated with Adalimumab
11004568|NCT01077128|OG009|Outcome|EQ5D- Self-care- Month 12|All eligible patients with psoriasis treated with Adalimumab
11004569|NCT01077128|OG010|Outcome|EQ5D- Usual Activities- Baseline|All eligible patients with psoriasis treated with Adalimumab
11004570|NCT01077128|OG011|Outcome|EQ5D- Usual Activities- Month 1|All eligible patients with psoriasis treated with Adalimumab
11004571|NCT01077128|OG012|Outcome|EQ5D- Usual Activities- Month 4|All eligible patients with psoriasis treated with Adalimumab
11004572|NCT01077128|OG013|Outcome|EQ5D- Usual Activities- Month 8|All eligible patients with psoriasis treated with Adalimumab
11004573|NCT01077128|OG014|Outcome|EQ5D- Usual Activities- Month 12|All eligible patients with psoriasis treated with Adalimumab
11004574|NCT01077128|OG015|Outcome|EQ5D- Pain/Discomfort- Baseline|All eligible patients with psoriasis treated with Adalimumab
11004575|NCT01077128|OG016|Outcome|EQ5D- Pain/Discomfort- Month 1|All eligible patients with psoriasis treated with Adalimumab
11004576|NCT01077128|OG017|Outcome|EQ5D- Pain/Discomfort- Month 4|All eligible patients with psoriasis treated with Adalimumab
11004577|NCT01077128|OG018|Outcome|EQ5D- Pain/Discomfort- Month 8|All eligible patients with psoriasis treated with Adalimumab
11004578|NCT01077128|OG019|Outcome|EQ5D- Pain/Discomfort- Month 12|All eligible patients with psoriasis treated with Adalimumab
11004579|NCT01077128|OG020|Outcome|EQ5D- Anxiety/Depression- Baseline|All eligible patients with psoriasis treated with Adalimumab
11004580|NCT01077128|OG021|Outcome|EQ5D- Anxiety/Depression- Month 1|All eligible patients with psoriasis treated with Adalimumab
11004581|NCT01077128|OG022|Outcome|EQ5D- Anxiety/Depression- Month 4|All eligible patients with psoriasis treated with Adalimumab
11004582|NCT01077128|OG023|Outcome|EQ5D- Anxiety/Depression- Month 8|All eligible patients with psoriasis treated with Adalimumab
11004583|NCT01077128|OG024|Outcome|EQ5D- Anxiety/Depression- Month 12|All eligible patients with psoriasis treated with Adalimumab
11004584|NCT01077128|OG000|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 1|All eligible patients with psoriasis treated with Adalimumab
11004585|NCT01077128|OG001|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 4|All eligible patients with psoriasis treated with Adalimumab
11004586|NCT01077128|OG002|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 8|All eligible patients with psoriasis treated with Adalimumab
11004587|NCT01077128|OG003|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 12|All eligible patients with psoriasis treated with Adalimumab
11004588|NCT01077128|OG000|Outcome|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab were followed for the long term use and safety of Adalimumab. For more detailed information, please see the Adverse Events section.
11004589|NCT01077128|EG000|Reported Event|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
11004590|NCT01077154|BG000|Baseline|Placebo|Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
11004591|NCT01077154|BG001|Baseline|Denosumab|Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
11004592|NCT01077154|BG002|Baseline|Total|Total of all reporting groups
11004593|NCT01077154|FG000|Participant Flow|Placebo|Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
11004594|NCT01077154|FG001|Participant Flow|Denosumab|Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
11004595|NCT01077154|OG000|Outcome|Placebo|Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
11004596|NCT01077154|OG001|Outcome|Denosumab|Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
11004597|NCT01077154|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
11004598|NCT01077154|EG001|Reported Event|Denosumab|Participants received denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
11004599|NCT01077193|BG000|Baseline|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
11004600|NCT01077193|FG000|Participant Flow|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
11004601|NCT01077193|OG000|Outcome|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
11004602|NCT01077193|EG000|Reported Event|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
11004603|NCT01077258|BG000|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
11004604|NCT01077258|FG000|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
11004605|NCT01077258|OG000|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
11004606|NCT01077258|OG000|Outcome|Month 0|Baseline
11004607|NCT01077258|OG001|Outcome|Month 3|3 months after inclusion
11004608|NCT01077258|OG002|Outcome|Month 6|6 months after inclusion
11004609|NCT01077258|OG003|Outcome|Month 9|9 months after inclusion
11004610|NCT01077258|OG004|Outcome|Month 12|12 months after inclusion
11004611|NCT01077258|OG005|Outcome|Month 18|18 months after inclusion
11004612|NCT01077258|OG006|Outcome|Month 24|24 months after inclusion
11004613|NCT01077258|OG004|Outcome|Month 18|18 months after inclusion
11004614|NCT01077258|OG005|Outcome|Month 24|24 months after inclusion
11004615|NCT01077258|EG000|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
11004616|NCT01077271|BG000|Baseline|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
11004617|NCT01077271|BG001|Baseline|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
11004618|NCT01077271|BG002|Baseline|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
11004619|NCT01077271|BG003|Baseline|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
11004620|NCT01077271|BG004|Baseline|Total|Total of all reporting groups
11004621|NCT01077271|FG000|Participant Flow|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
11004622|NCT01077271|OG000|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
11004623|NCT01077271|OG001|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
11004624|NCT01077271|OG002|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
11106432|NCT01621490|OG001|Outcome|N3 60M Prog|N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion;PROG = Anti-CTLA4 Progressed;
11106433|NCT01621490|OG002|Outcome|N1 60M+I3 90M|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion
11106434|NCT01621490|OG004|Outcome|N3 30M Non-BM|N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases;
11106435|NCT01621490|OG005|Outcome|N3 30M + I3 30M BM|N3 = Nivolumab 3mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106436|NCT01621490|OG007|Outcome|N1 + I3 Non-BM|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases
11106437|NCT01621490|OG008|Outcome|N3 Naive|N3 = Nivolumab 3mg/kg; NAIVE = Anti-CTLA4 Naive
11106438|NCT01621490|OG009|Outcome|N3 Only|N3 = Nivolumab 3mg/kg
11106439|NCT01621490|OG010|Outcome|N1 + I3|All combination treatments
11106440|NCT01621490|OG001|Outcome|N3 60M PROG|N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion;PROG = Anti-CTLA4 Progressed;
11106441|NCT01621490|OG003|Outcome|N1 30M + I3 30M NON-BM|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106442|NCT01621490|OG004|Outcome|N3 30M NON-BM|N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106443|NCT01621490|OG005|Outcome|N1 30M + I3 30M BM|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases
11106444|NCT01621490|OG007|Outcome|N1 + I3 NON-BM|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases
11106445|NCT01621490|OG008|Outcome|N3 NAIVE|N3 = Nivolumab 3mg/kg; NAIVE = Anti-CTLA4 Naive
11106446|NCT01621490|OG009|Outcome|All N3|N3 = Nivolumab 3mg/kg
11106447|NCT01621490|OG010|Outcome|N1 + I3|All combination
11106448|NCT01621490|OG000|Outcome|N3 60M NAIVE|Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive
11106449|NCT01621490|OG001|Outcome|N3 60M PROG|Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Progressed
11106450|NCT01621490|OG002|Outcome|N1 60M + I3 (Nivo ADA|Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute
11106451|NCT01621490|OG003|Outcome|N1 60M + I3 90M (Ipi ADA)|Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute
11106452|NCT01621490|OG004|Outcome|N1 30M + I3 30M Non-BM (Nivo ADA)|Part 3: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106453|NCT01621490|OG005|Outcome|N1 30M + I3 30M Non-BM (Ipi ADA)|Part 3: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106454|NCT01621490|OG006|Outcome|N3 30M Non-BM|Part 3: Nivolumab 3 mg/kg 30 Minute Infusion Non-Brain Metastases
11106455|NCT01621490|OG007|Outcome|N1 30M + I3 30M (Nivo ADA)|Part 4: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106456|NCT01621490|OG008|Outcome|N1 30M + I3 30M (Ipi ADA)|Part 4: Nivolumab 1 mg/kg 30 Minute Infusion + Ipilimumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106457|NCT01621490|OG009|Outcome|N3 30M BM|Part 4: Nivolumab 3 mg/kg 30 Minute Infusion Brain Metastases
11106458|NCT01621490|OG010|Outcome|Total (Nivo ADA)|Total (All Nivolumab or Nivolumab + Ipilimumab Treated Subjects with Baseline and at Least One Post-Baseline Assessment)
11106459|NCT01621490|OG011|Outcome|Total (Ipi ADA)|Total (All Nivolumab or Nivolumab + Ipilimumab Treated Subjects with Baseline and at Least One Post-Baseline Assessment)
11106460|NCT01621490|OG000|Outcome|N3 60M NAIVE, W4|Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; NAIVE = Anti-CTLA4 Naive
11106461|NCT01621490|OG001|Outcome|N3 60M PROG, W4|Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed;
11106462|NCT01621490|OG002|Outcome|N1 60M + I3 90M, W2|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W2 = Week 2 Biopsy;
11106463|NCT01621490|OG003|Outcome|N1 60M + I3 90M, W4|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; 30M = 30 minute infusion; W4 = Week 4 Biopsy;
11106464|NCT01621490|OG004|Outcome|N1 60M + I3 90M, WU|Treatment Group: N3 = Nivolumab 3mg/kg; N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; WU = Unknown Week Biopsy
11106465|NCT01621490|OG005|Outcome|N1 30M + I3 30M NON-BM|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases
11106466|NCT01621490|OG006|Outcome|N3 30M NON-BM, W2|Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; W2 = Week 2 Biopsy
11106467|NCT01621490|OG007|Outcome|N1 30M + I3 30M BM, W2|Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; W2 = Week 2 Biopsy
11106468|NCT01621490|OG008|Outcome|N3 30M BM, W2|Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; W2 = Week 2 Biopsy
11106469|NCT01621490|OG009|Outcome|N3 60M, W4|N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; W4 = Week 4 Biopsy
11106470|NCT01621490|OG010|Outcome|N3 30M, W2|Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; W2 = Week 2 Biopsy
11106471|NCT01621490|OG011|Outcome|N1 + I3, W2|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; W2 = Week 2 Biopsy
11106472|NCT01621490|OG012|Outcome|N1 + I3 W2, NON-BM|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; W2 = Week 2 Biopsy; BM = Brain metastases
11106473|NCT01621490|OG013|Outcome|N3 NAIVE, NON-BM|N3 = Nivolumab 3mg/kg; NAIVE = Anti-CTLA4 Naive; BM = Brain metastases
11106474|NCT01621490|OG014|Outcome|N1 + I3 NON-BM|N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases
11106475|NCT01621490|OG015|Outcome|Total|All treatments
11106476|NCT01621490|EG000|Reported Event|UNPLANNED|Unplanned
11106477|NCT01621490|EG001|Reported Event|NIV3-NAIVE|Treatment Group: NIV3 = Nivolumab 3mg/kg; NAIVE = Anti-CTLA4 Naive
11106478|NCT01621490|EG002|Reported Event|NIV3-PROG|Treatment Group: NIV3 = Nivolumab 3mg/kg; PROG = Anti-CTLA4 Progressed
11106479|NCT01621490|EG003|Reported Event|NIV1+IPI3 P2|Treatment Group:NIV1 = Nivolumab 1mg/kg; IPI3 = Ipilimumab 3 mg/kg; P2 = Part 2
11106480|NCT01621490|EG004|Reported Event|NIV1+IPI3 P3|Treatment Group: NIV1 = Nivolumab 1mg/kg; IPI3 = Ipilimumab 3 mg/kg; P3 = Part 3
11106481|NCT01621490|EG005|Reported Event|NIV3-Q2W P3|Treatment Group: NIV3 = Nivolumab 3mg/kg; Q2W = every 2 weeks; P3 = Part 3
11106482|NCT01621490|EG006|Reported Event|IPI3-Q3W P3|Treatment Group: IPI3 = Ipilimumab 3 mg/kg; Q3W = Every 3 weeks; P3 = Part 3
11106483|NCT01621490|EG007|Reported Event|NIV1+IPI3 P4|Treatment Group: NIV1 = Nivolumab 1mg/kg; IPI3 = Ipilimumab 3 mg/kg; P4 = Part 4
11106484|NCT01621490|EG008|Reported Event|NIV3-Q2W P4|Treatment Group: N3 = Nivolumab 3mg/kg; Q2W = Every 2 weeks; P4 = Part 4
11106485|NCT01621542|BG000|Baseline|WT2725 0.3 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106486|NCT01621542|BG001|Baseline|WT2725 0.9 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106487|NCT01621542|BG002|Baseline|WT2725 3.0 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106488|NCT01621542|BG003|Baseline|WT2725 9 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106489|NCT01621542|BG004|Baseline|WT2725 18 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106490|NCT01621542|BG005|Baseline|WT2725 27 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106491|NCT01621542|BG006|Baseline|Total|Total of all reporting groups
11106492|NCT01621542|FG000|Participant Flow|WT2725 0.3 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106493|NCT01621542|FG001|Participant Flow|WT2725 0.9 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106494|NCT01621542|FG002|Participant Flow|WT2725 3.0 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106495|NCT01621542|FG003|Participant Flow|WT2725 9 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106496|NCT01621542|FG004|Participant Flow|WT2725 18 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106497|NCT01621542|FG005|Participant Flow|WT2725 27 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106498|NCT01621542|OG000|Outcome|WT2725 0.3 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106499|NCT01621542|OG001|Outcome|WT2725 0.9 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106500|NCT01621542|OG002|Outcome|WT2725 3.0 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106501|NCT01621542|OG003|Outcome|WT2725 9 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106502|NCT01621542|OG004|Outcome|WT2725 18 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106503|NCT01621542|OG005|Outcome|WT2725 27 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106504|NCT01621542|EG000|Reported Event|WT2725 0.3 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106505|NCT01621542|EG001|Reported Event|WT2725 0.9 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106506|NCT01621542|EG002|Reported Event|WT2725 3.0 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106507|NCT01621542|EG003|Reported Event|WT2725 9 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106508|NCT01621542|EG004|Reported Event|WT2725 18 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106509|NCT01621542|EG005|Reported Event|WT2725 27 mg|WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
11106510|NCT01621633|BG000|Baseline|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
11106511|NCT01621633|BG001|Baseline|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
11106512|NCT01621633|BG002|Baseline|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
10846801|NCT00280059|BG001|Baseline|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
11106513|NCT01621633|BG003|Baseline|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
11106514|NCT01621633|BG004|Baseline|Total|Total of all reporting groups
11106515|NCT01621633|FG000|Participant Flow|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
11106516|NCT01621633|FG001|Participant Flow|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
11106517|NCT01621633|FG002|Participant Flow|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
11106518|NCT01621633|FG003|Participant Flow|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
11106519|NCT01621633|OG000|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
11106520|NCT01621633|OG001|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
11106521|NCT01621633|OG002|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
11106522|NCT01621633|OG003|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
11106523|NCT01621633|EG000|Reported Event|Moderate Hepatic Impaired Patients|Moderate hepatic impaired patients
11106524|NCT01621633|EG001|Reported Event|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
11106525|NCT01621633|EG002|Reported Event|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
11106526|NCT01621633|EG003|Reported Event|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
11106527|NCT01621672|BG000|Baseline|Revlimid|Revlimid: 10 mg/day in the morning same time each day
11106528|NCT01621672|BG001|Baseline|Observation|No treatment
11106529|NCT01621672|BG002|Baseline|Total|Total of all reporting groups
11106530|NCT01621672|FG000|Participant Flow|Revlimid|Revlimid: 10 mg/day in the morning same time each day
11106531|NCT01621672|FG001|Participant Flow|Observation|No treatment
11106532|NCT01621672|OG000|Outcome|Revlimid|Revlimid: 10 mg/day in the morning same time each day
11106533|NCT01621672|OG001|Outcome|Observation|No treatment
11106534|NCT01621672|EG000|Reported Event|Revlimid|Revlimid: 10 mg/day in the morning same time each day
11106535|NCT01621672|EG001|Reported Event|Observation|No treatment
11106536|NCT01621776|BG000|Baseline|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
11106537|NCT01621776|BG001|Baseline|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
10846802|NCT00280059|BG002|Baseline|Total|Total of all reporting groups
11106538|NCT01621776|BG002|Baseline|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
11106539|NCT01621776|BG003|Baseline|Total|Total of all reporting groups
11106540|NCT01621776|FG000|Participant Flow|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
11106541|NCT01621776|FG001|Participant Flow|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
11106542|NCT01621776|FG002|Participant Flow|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
11106543|NCT01621776|OG000|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
11106544|NCT01621776|OG001|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
11106545|NCT01621776|OG002|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
11106546|NCT01621776|EG000|Reported Event|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
11106547|NCT01621776|EG001|Reported Event|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
11106548|NCT01621776|EG002|Reported Event|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
11106549|NCT01621802|BG000|Baseline|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106550|NCT01621802|BG001|Baseline|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106551|NCT01621802|BG002|Baseline|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
11106552|NCT01621802|BG003|Baseline|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106553|NCT01621802|BG004|Baseline|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
11106554|NCT01621802|BG005|Baseline|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106555|NCT01621802|BG006|Baseline|Total|Total of all reporting groups
11106556|NCT01621802|FG000|Participant Flow|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106557|NCT01621802|FG001|Participant Flow|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106558|NCT01621802|FG002|Participant Flow|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
11106559|NCT01621802|FG003|Participant Flow|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106560|NCT01621802|FG004|Participant Flow|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
11106561|NCT01621802|FG005|Participant Flow|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106562|NCT01621802|OG000|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106563|NCT01621802|OG001|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106564|NCT01621802|OG002|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
11106565|NCT01621802|OG003|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106566|NCT01621802|OG004|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
11106567|NCT01621802|OG005|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106568|NCT01621802|OG001|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-RII (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106569|NCT01621802|OG003|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106570|NCT01621802|OG005|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106571|NCT01621802|EG000|Reported Event|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106572|NCT01621802|EG001|Reported Event|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
11106573|NCT01621802|EG002|Reported Event|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
11106574|NCT01621802|EG003|Reported Event|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106575|NCT01621802|EG004|Reported Event|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
11106576|NCT01621802|EG005|Reported Event|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11106577|NCT01621880|BG000|Baseline|Bevacizumab|"Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity."
11106578|NCT01621880|BG001|Baseline|Corticosteroid|"Patients in the corticosteroid group were treated with methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped.~Corticosteroid: Patients in the corticosteroid group were treated with methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped."
11106579|NCT01621880|BG002|Baseline|Total|Total of all reporting groups
11106580|NCT01621880|FG000|Participant Flow|Bevacizumab|"Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity."
11106581|NCT01621880|FG001|Participant Flow|Corticosteroid|"Patients in the corticosteroid group were treated with methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped.~Corticosteroid: Patients in the corticosteroid group were treated with intravenous pulsed-steroid therapy: methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped."
11106582|NCT01621880|OG000|Outcome|Bevacizumab|"Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity."
11106583|NCT01621880|OG001|Outcome|Corticosteroid|"Patients in the corticosteroid group were treated with methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped.~Corticosteroid: Patients in the corticosteroid group were treated with intravenous pulsed-steroid therapy: methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped."
11336506|NCT03567291|FG001|Participant Flow|Randomized TEV-50717|Participants were randomized to their current dose of TEV-50717, which was administered during the Part B Randomized Drug Withdrawal (RW) 2-week period.
11336507|NCT03567291|FG002|Participant Flow|Randomized Placebo|Participants were randomized to placebo, which was administered during the Part B Randomized Drug Withdrawal (RW) 2-week period only.
11106584|NCT01621880|OG001|Outcome|Corticosteroid|"Patients in the corticosteroid group were treated methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped.~Corticosteroid: Patients in the corticosteroid group were treated with intravenous pulsed-steroid therapy: methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped."
11106585|NCT01621880|EG000|Reported Event|Bevacizumab|"Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity."
11106586|NCT01621880|EG001|Reported Event|Corticosteroid|"Patients in the corticosteroid group were treated with methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped.~Corticosteroid: Patients in the corticosteroid group were treated with intravenous pulsed-steroid therapy: methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped."
11106587|NCT01622010|BG000|Baseline|Standard Care With Video Enhancement|"Allied Health Education Class Option: An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.~Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.~Keeping the Beat with Physiotherapy: Heart Failure edition: Educational DVD covering the basics of physiotherapy education for the patient with heart failure."
11106588|NCT01622010|BG001|Baseline|Standard Care|"Allied Health Education Class Option: An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.~Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription."
11106589|NCT01622010|BG002|Baseline|Total|Total of all reporting groups
11106590|NCT01622010|FG000|Participant Flow|Standard Care With Video Enhancement|"Allied Health Education Class Option: An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.~Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.~Keeping the Beat with Physiotherapy: Heart Failure edition: Educational DVD covering the basics of physiotherapy education for the patient with heart failure."
11106591|NCT01622010|FG001|Participant Flow|Standard Care|"Allied Health Education Class Option: An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.~Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription."
11106592|NCT01622010|OG000|Outcome|Standard Care With Video Enhancement|"Allied Health Education Class Option: An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.~Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.~Keeping the Beat with Physiotherapy: Heart Failure edition: Educational DVD covering the basics of physiotherapy education for the patient with heart failure."
10845998|NCT00272168|BG001|Baseline|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
11106593|NCT01622010|OG001|Outcome|Standard Care|"Allied Health Education Class Option: An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.~Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription."
11106594|NCT01622010|OG000|Outcome|Standard Care With Video Enhancement|"Allied Health Education Class Option~Physiotherapy treatment intervention on referral~Keeping the Beat with Physiotherapy: Heart Failure edition: Educational DVD"
11106595|NCT01622010|OG001|Outcome|Standard Care|"Allied Health Education Class Option~Physiotherapy treatment intervention on referral"
11126586|NCT01734382|OG002|Outcome|Part 2: TCZ IV 8 mg/kg Q3W/Q4W|Participants with weight >/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.
11106596|NCT01622010|EG000|Reported Event|Standard Care With Video Enhancement|"Allied Health Education Class Option: An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.~Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.~Keeping the Beat with Physiotherapy: Heart Failure edition: Educational DVD covering the basics of physiotherapy education for the patient with heart failure."
11106597|NCT01622010|EG001|Reported Event|Standard Care|"Allied Health Education Class Option: An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.~Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription."
11106598|NCT01622231|BG000|Baseline|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
11106599|NCT01622231|FG000|Participant Flow|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
11106600|NCT01622231|OG000|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
11106601|NCT01622231|EG000|Reported Event|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
11106602|NCT01622257|BG000|Baseline|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
11106603|NCT01622257|BG001|Baseline|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
11106604|NCT01622257|BG002|Baseline|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
11106605|NCT01622257|BG003|Baseline|Total|Total of all reporting groups
11106606|NCT01622257|FG000|Participant Flow|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
11106607|NCT01622257|FG001|Participant Flow|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
11106608|NCT01622257|FG002|Participant Flow|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
11106609|NCT01622257|OG000|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
11106610|NCT01622257|OG001|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
11106611|NCT01622257|OG002|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
11106612|NCT01622257|EG000|Reported Event|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
11106613|NCT01622257|EG001|Reported Event|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
11106614|NCT01622257|EG002|Reported Event|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
11106615|NCT01622296|BG000|Baseline|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
11106616|NCT01622296|FG000|Participant Flow|Lidocaine First, Then Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
11106617|NCT01622296|FG001|Participant Flow|Buffered Lidocaine First, Then Lidocaine|buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
11106618|NCT01622296|OG000|Outcome|Lidocaine|2% lidocaine with 1:100,000 ppm epinephrine
11106619|NCT01622296|OG001|Outcome|Buffered Lidocaine|2% buffered lidocaine with 1:100,000 ppm epinephrine
10845999|NCT00272168|BG002|Baseline|Total|Total of all reporting groups
11106620|NCT01622296|EG000|Reported Event|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
11106621|NCT01622348|BG000|Baseline|IMO-3100 at 0.16 mg/kg|"IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection~IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection"
11106622|NCT01622348|BG001|Baseline|IMO-3100 at 0.32 mg/kg|"IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection~IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection"
11106623|NCT01622348|BG002|Baseline|Placebo|"Saline for Injection~Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL"
11106624|NCT01622348|BG003|Baseline|Total|Total of all reporting groups
11106625|NCT01622348|FG000|Participant Flow|IMO-3100 at 0.16 mg/kg|"IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection~IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection"
11106626|NCT01622348|FG001|Participant Flow|IMO-3100 at 0.32 mg/kg|"IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection~IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection"
11106627|NCT01622348|FG002|Participant Flow|Placebo|"Saline for Injection~Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL"
11106628|NCT01622348|OG000|Outcome|IMO-3100 at 0.16 mg/kg|"IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection~IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection"
11004625|NCT01077271|OG003|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
11004626|NCT01077271|OG004|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
11004627|NCT01077271|OG000|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
11004628|NCT01077271|OG001|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
11004629|NCT01077271|OG002|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
11004630|NCT01077271|OG003|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
11004631|NCT01077271|EG000|Reported Event|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
11004632|NCT01077284|BG000|Baseline|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
11004633|NCT01077284|BG001|Baseline|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
11004634|NCT01077284|BG002|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
11004635|NCT01077284|BG003|Baseline|Total|Total of all reporting groups
11004636|NCT01077284|FG000|Participant Flow|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
11004637|NCT01077284|FG001|Participant Flow|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
11004638|NCT01077284|FG002|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
11004639|NCT01077284|OG000|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
11004640|NCT01077284|OG001|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
11004641|NCT01077284|OG002|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
11004642|NCT01077284|EG000|Reported Event|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
11004643|NCT01077284|EG001|Reported Event|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
11004644|NCT01077284|EG002|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
11004645|NCT01077310|BG000|Baseline|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
11004646|NCT01077310|BG001|Baseline|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
11004647|NCT01077310|BG002|Baseline|Total|Total of all reporting groups
11004648|NCT01077310|FG000|Participant Flow|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
11004649|NCT01077310|FG001|Participant Flow|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
11004650|NCT01077310|OG000|Outcome|Intramuscular Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
11004651|NCT01077310|OG001|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
11004652|NCT01077310|OG000|Outcome|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
11106629|NCT01622348|OG001|Outcome|IMO-3100 at 0.32 mg/kg|"IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection~IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection"
11106630|NCT01622348|OG002|Outcome|Placebo|"Saline for Injection~Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL"
11106631|NCT01622348|EG000|Reported Event|IMO-3100 at 0.16 mg/kg|"IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection~IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection"
11106632|NCT01622348|EG001|Reported Event|IMO-3100 at 0.32 mg/kg|"IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection~IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection"
11106633|NCT01622348|EG002|Reported Event|Placebo|"Saline for Injection~Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL"
11106634|NCT01622543|BG000|Baseline|Folfox Plus Bevacizumab and Reolysin|Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
11106635|NCT01622543|BG001|Baseline|Folfox Plus Bevacizumab|Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
11106636|NCT01622543|BG002|Baseline|Total|Total of all reporting groups
11106637|NCT01622543|FG000|Participant Flow|Folfox Plus Bevacizumab and Reolysin|Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab infusion on day 1 of a 14 day cycle (IV bevacizumab 5mg/kg over 1 hour, oxaliplatin 85mg/m^2 and leucovorin 400 mg/m^2 concurrently over 2 hours, bolus fluorouracil 400 mg/m^2 after leucovorin, and continuous infusion of fluorouracil 2400 mg/m^2 over 46 hours) and reolysin 3x10^10 TCID_50 over 1 hour on days 1-5 of cycle 2, 4, 6, 8 and alternate cycles thereafter.
11106638|NCT01622543|FG001|Participant Flow|Folfox Plus Bevacizumab|Folfox plus Bevacizumab: FOLFOX6/bevacizumab infusion on day 1 of a 14 day cycle (IV bevacizumab 5mg/kg over 1 hour, oxaliplatin 85mg/m^2 and leucovorin 400 mg/m^2 concurrently over 2 hours, bolus fluorouracil 400 mg/m^2 after leucovorin, and continuous infusion of fluorouracil 2400 mg/m^2 over 46 hours).
11106639|NCT01622543|OG000|Outcome|Folfox Plus Bevacizumab and Reolysin|Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
11106640|NCT01622543|OG001|Outcome|Folfox Plus Bevacizumab|Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
11106641|NCT01622543|EG000|Reported Event|Folfox Plus Bevacizumab and Reolysin|Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
11106642|NCT01622543|EG001|Reported Event|Folfox Plus Bevacizumab|Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
11106643|NCT01622569|BG000|Baseline|Placebo|Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106644|NCT01622569|BG001|Baseline|OPN-375 100 μg BID|OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106645|NCT01622569|BG002|Baseline|OPN-375 200 μg BID|OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
10846000|NCT00272168|FG000|Participant Flow|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
11106646|NCT01622569|BG003|Baseline|OPN-375 400 μg BID|OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106647|NCT01622569|BG004|Baseline|Total|Total of all reporting groups
11106648|NCT01622569|FG000|Participant Flow|Placebo|Matching placebo BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
11106649|NCT01622569|FG001|Participant Flow|100 μg OPN-375|OPN-375 100 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
11106650|NCT01622569|FG002|Participant Flow|200 μg OPN-375|OPN-375 200 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
11106651|NCT01622569|FG003|Participant Flow|400 μg EDS-FLU|OPN-375 400 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
11106652|NCT01622569|OG000|Outcome|Placebo|Matching Placebo Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106653|NCT01622569|OG001|Outcome|OPN-375 100 μg BID|OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106654|NCT01622569|OG002|Outcome|OPN-375 200 μg BID|OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106655|NCT01622569|OG003|Outcome|OPN-375 400 μg BID|OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106656|NCT01622569|OG000|Outcome|Placebo|Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106657|NCT01622569|OG001|Outcome|OPN-375 100 μg Twice Daily|100 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106658|NCT01622569|OG002|Outcome|OPN-375 200 μg Twice Daily|200 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106659|NCT01622569|OG003|Outcome|OPN-375 400 μg Twice Daily|OPN-375 400 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106660|NCT01622569|OG003|Outcome|OPN-375 400 μg Twice Daily|400 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
11106661|NCT01622569|OG000|Outcome|Placebo|Matching placebo BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
11106662|NCT01622569|OG001|Outcome|100 μg OPN-375|OPN-375 100 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
11106663|NCT01622569|OG002|Outcome|200 μg OPN-375|OPN-375 200 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
11106664|NCT01622569|OG003|Outcome|400 μg EDS-FLU|OPN-375 400 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
11106665|NCT01622569|EG000|Reported Event|Placebo (Double-Blind Phase)|100 μg BID or 200 μg BID or 400 μg Matching Placebo BID x 16 weeks
11106666|NCT01622569|EG001|Reported Event|OPN-375 100 μg BID (Double-Blind Phase)|OPN-375 100 μg BID x 16 weeks
11106667|NCT01622569|EG002|Reported Event|OPN-375 200 μg BID (Double-Blind Phase)|OPN-375 200 μg BID x 16 weeks
11106668|NCT01622569|EG003|Reported Event|OPN-375 400 μg BID (Double-Blind Phase)|OPN-375 400 μg BID x 16 weeks
11106669|NCT01622569|EG004|Reported Event|OPN-375 400 μg (Open-Label Phase)|OPN-375 400 μg BID x 8 weeks
11106670|NCT01622660|BG000|Baseline|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.~Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
11106671|NCT01622660|FG000|Participant Flow|Gemcitabine and Pazopanib|Chemotherapy naïve participants with advanced/metastatic urothelial carcinoma ineligible for Cisplatin-based chemotherapy
11106672|NCT01622660|OG000|Outcome|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.~Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
11106673|NCT01622660|EG000|Reported Event|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.~Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
11106674|NCT01622673|BG000|Baseline|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
11106675|NCT01622673|BG001|Baseline|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106676|NCT01622673|BG002|Baseline|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106677|NCT01622673|BG003|Baseline|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106678|NCT01622673|BG004|Baseline|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106679|NCT01622673|BG005|Baseline|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106680|NCT01622673|BG006|Baseline|Total|Total of all reporting groups
11106681|NCT01622673|FG000|Participant Flow|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
11106682|NCT01622673|FG001|Participant Flow|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106683|NCT01622673|FG002|Participant Flow|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106684|NCT01622673|FG003|Participant Flow|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106685|NCT01622673|FG004|Participant Flow|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106686|NCT01622673|FG005|Participant Flow|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
11106687|NCT01622673|OG000|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
11106688|NCT01622673|OG001|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
11106689|NCT01622673|OG002|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
11106690|NCT01622673|OG001|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
11106691|NCT01622673|OG002|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
11106692|NCT01622673|OG001|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
11106693|NCT01622673|OG003|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
11106694|NCT01622673|OG004|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
11106695|NCT01622673|OG001|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of AE assessment
11106696|NCT01622673|OG002|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of AE assessment
11106697|NCT01622673|OG003|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of AE assessment
11106698|NCT01622673|OG004|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of AE assessment
11106699|NCT01622673|EG000|Reported Event|Raltegravir|Raltegravir 400 mg every 12 hours
11106700|NCT01622673|EG001|Reported Event|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
11106701|NCT01622673|EG002|Reported Event|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
11106702|NCT01622673|EG003|Reported Event|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
11106703|NCT01622673|EG004|Reported Event|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
11106704|NCT01622699|BG000|Baseline|Transcutaneous Bilirubin Measurements|patients that were randomized to get bilirubine measurements through the transcutaneous bilirubinometer
11106705|NCT01622699|BG001|Baseline|Visual Assessment of Neonatal Jaundice|patients that were randomized NOT to get bilirubinemeasurements through the transcutaneous bilirubinometer
11106706|NCT01622699|BG002|Baseline|Total|Total of all reporting groups
11106707|NCT01622699|FG000|Participant Flow|Transcutaneous Bilirubin Measurements|patients that were randomized to get bilirubinemeasurements through the transcutaneous bilirubinometer
11106708|NCT01622699|FG001|Participant Flow|Visual Assessment of Neonatal Jaundice|pateients that were randomized to the standrad treatemnt, thus withoutthe use of the transcutaneous bilirubinometer
11336508|NCT03567291|FG003|Participant Flow|TEV-50717 Re-titration and Maintenance|Participants who were randomized to placebo during the withdrawal period were re-titrated to their TEV-50717 maintenance dose. Participants who were randomized to TEV-50717 continued their maintenance dose.
11106709|NCT01622699|OG000|Outcome|Transcutaneous Bilirubin Measurements|"In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer~Transcutaneous Bilirubinometer: If a baby is jaundiced, the ward-nurse will perform a transcutaneous bilirubin measurement. It takes about 5 seconds to perform the measurement at the forehead or sternum of the baby. The device is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. This is not an invasive procedure: A light-reflection is used to measure transcutaneous bilirubin."
11106710|NCT01622699|OG001|Outcome|Visual Assessment of Neonatal Jaundice|"In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician~visual assessment of neonatal jaundice: To detect newborns with jaundice (who will possibly meet the criteria for phototherapy) there have been international guidelines formulated by the American Academy of Pediatrics. The standard of care at the neonatal- and maternity ward of our hospital to detect those newborns is visual assessment according to these guidelines."
11106711|NCT01622699|EG000|Reported Event|Transcutaneous Measurement|patients that were randomized to get bilirubinemeasurements through the transcutaneous bilirubinometer
11106712|NCT01622699|EG001|Reported Event|Visual Assessment of Neonatal Jaundice|patients that were randomized NOT to get bilirubinemeasurements through the transcutaneous bilirubinometer
11106713|NCT01623037|BG000|Baseline|CoolSculpting Treatment Group|"The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol.~The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration."
11106714|NCT01623037|FG000|Participant Flow|CoolSculpting Treatment Group|"The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol.~The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration."
11106715|NCT01623037|OG000|Outcome|CoolSculpting Treatment Group|"The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol.~The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration."
11106716|NCT01623037|OG000|Outcome|Operator Feedback on CoolCurve Applicator|The operator assessed the fit and tissue draw into each of 2 applicators. The assessment was done using a multiple choice questionnaire for each applicator type.
11106717|NCT01623037|OG001|Outcome|Operator Feedback on CoolCurve + Applicator|The operator assessed the fit and tissue draw into each of 2 applicators. The assessment was done using a multiple choice questionnaire for each applicator type.
11106718|NCT01623037|EG000|Reported Event|CoolSculpting Treatment Group|"The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol.~The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration."
11106719|NCT01623050|BG000|Baseline|SinuSys Dilation System|"Maxillary Sinus Dilation~SinuSys Dilation System: Sinuplasty"
11106720|NCT01623050|FG000|Participant Flow|SinuSys Dilation System|Maxillary Sinus Dilation
11106721|NCT01623050|OG000|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
11106722|NCT01623050|EG000|Reported Event|SinuSys Dilation System|Maxillary Sinus Dilation
11106723|NCT01623115|BG000|Baseline|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
11106724|NCT01623115|BG001|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
11106725|NCT01623115|BG002|Baseline|Total|Total of all reporting groups
11106726|NCT01623115|FG000|Participant Flow|Placebo|Placebo for alirocumab subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
11106727|NCT01623115|FG001|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
11106728|NCT01623115|OG000|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
11106729|NCT01623115|OG001|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
11106730|NCT01623115|EG000|Reported Event|Placebo|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 72 weeks).
11106731|NCT01623115|EG001|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W on top of stable LMT (mean exposure of 72 weeks).
11106732|NCT01623154|BG000|Baseline|BreathTek UBT|Comparison of urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300. UBiT-IR300 is the FDA approved device.
11106733|NCT01623154|FG000|Participant Flow|Urea Hydrolysis Rate (UHR)|"Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT -IR300~Same patients will be tested on both the POCone and UBiT-IR300"
11106734|NCT01623154|OG000|Outcome|Urea Hydrolysis Rate (UHR) Values|Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone compared to the the approved device, UBiT-IR300. Three regression analyses completed (Deming, Passing-Bablok and Regular regression).
11106735|NCT01623154|OG000|Outcome|UBiT-IR300|This is the FDA approved device.
11106736|NCT01623154|OG001|Outcome|POCone|This is the device being tested and compared to the FDA approved device.
11106737|NCT01623154|EG000|Reported Event|Pranactin Citric Solution|At each visit, each subject provided baseline breath samples by exhaling into the mouthpiece of the 3 Baseline bags (Blue bags, labeled A,B, C according to collection order), received one 4 oz administration of Pranctin Citric solution (mixed in water, drink using a straw), waited 15 minutes and provided the Post-Dose breath samples (Pink bags, labeled A, B, C). The Blue and Pink bags were paired and tested in no particular order on each instrument. The subjects who tested positive for H.pylori underwent a second set of tests 28 days after completion of eradication therapy.
11106738|NCT01623271|BG000|Baseline|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
11106739|NCT01623271|FG000|Participant Flow|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
11106740|NCT01623271|OG000|Outcome|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
11106741|NCT01623271|EG000|Reported Event|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
11106742|NCT01623310|BG000|Baseline|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
11106743|NCT01623310|FG000|Participant Flow|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
11106744|NCT01623310|OG000|Outcome|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
11106745|NCT01623310|EG000|Reported Event|Fluticasone|"400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device~Fluticasone Proprionate using OptiNose Device"
11106746|NCT01623323|BG000|Baseline|OPN-375|OPN-375 400 mcg/twice daily
11106747|NCT01623323|FG000|Participant Flow|OPN-375|OPN-375 400 mcg/twice daily
11106748|NCT01623323|OG000|Outcome|OPN-375|OPN-375 400 mcg/twice daily
11106749|NCT01623323|EG000|Reported Event|OPN-375|OPN-375 400 mcg/twice daily
11106750|NCT01623466|BG000|Baseline|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
11106751|NCT01623466|BG001|Baseline|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
11106752|NCT01623466|BG002|Baseline|Total|Total of all reporting groups
11106753|NCT01623466|FG000|Participant Flow|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
11106754|NCT01623466|FG001|Participant Flow|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
11106755|NCT01623466|OG000|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
11106756|NCT01623466|OG001|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
11106757|NCT01623466|EG000|Reported Event|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
11106758|NCT01623466|EG001|Reported Event|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
11126587|NCT01734382|EG000|Reported Event|Part 1: Tocilizumab (TCZ) Q2W|Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants < 30 kg; 8 mg/kg for participants >/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study.
11126588|NCT01734382|EG001|Reported Event|Part 2: TCZ IV 12 mg/kg Q3W/Q4W|Participants with weight < 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.
11126589|NCT01734382|EG002|Reported Event|Part 2: TCZ IV 8 mg/kg Q3W/Q4W|Participants with weight >/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.
11126590|NCT01734395|BG000|Baseline|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
11126591|NCT01734395|FG000|Participant Flow|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
11126592|NCT01734395|OG000|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
11126593|NCT01734395|EG000|Reported Event|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
11126594|NCT01734434|BG000|Baseline|Maternal Subjects (Dominican Republic)|Pregnant women who were enrolled in Dominican Republic.
11126595|NCT01734434|BG001|Baseline|Maternal Subjects (Panama)|Pregnant women who were enrolled in Panama.
11126596|NCT01734434|BG002|Baseline|Maternal Subjects (South Africa)|Pregnant women who were enrolled in South Africa.
11126597|NCT01734434|BG003|Baseline|Maternal Subjects (Mozambique)|Pregnant women who were enrolled in Mozambique.
11126598|NCT01734434|BG004|Baseline|Total|Total of all reporting groups
11126599|NCT01734434|FG000|Participant Flow|Maternal Subjects (Dominican Republic)|Pregnant women who were enrolled in Dominican Republic.
11126600|NCT01734434|FG001|Participant Flow|Maternal Subjects (Panama)|Pregnant women who were enrolled in Panama.
11126601|NCT01734434|FG002|Participant Flow|Maternal Subjects (South Africa)|Pregnant women who were enrolled in South Africa.
11126602|NCT01734434|FG003|Participant Flow|Maternal Subjects (Mozambique)|Pregnant women who were enrolled in Mozambique.
11126603|NCT01734434|OG000|Outcome|Maternal Subjects (Dominican Republic)|Pregnant women who were enrolled in Dominican Republic.
11106759|NCT01623479|BG000|Baseline|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
11106760|NCT01623479|FG000|Participant Flow|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
11106761|NCT01623479|OG000|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
11106762|NCT01623479|EG000|Reported Event|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
11106763|NCT01623531|BG000|Baseline|RiaSTAP|"Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula~Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)"
11106764|NCT01623531|BG001|Baseline|Intravenous Saline|"Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula~Placebo: Intravenous saline will be infused with the same volume of the study drug."
11106765|NCT01623531|BG002|Baseline|Total|Total of all reporting groups
11106766|NCT01623531|FG000|Participant Flow|RiaSTAP|"Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula~Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)"
11106767|NCT01623531|FG001|Participant Flow|Intravenous Saline|"Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula~Placebo: Intravenous saline will be administered with the same volume as study drug"
11106768|NCT01623531|OG000|Outcome|RiaSTAP|"Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula~Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)"
11106769|NCT01623531|OG001|Outcome|Intravenous Saline|"Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula~Placebo: Intravenous placebo will be infused with the same volume as the study drug."
11106770|NCT01623531|OG001|Outcome|Intravenous Saline|"Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula~Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)"
11106771|NCT01623531|OG001|Outcome|Intravenous Saline|"Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula~Placebo: Intravenous saline will be administered with the same volume as study drug"
11106772|NCT01623531|OG001|Outcome|Intravenous Saline|"Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula~Placebo: Intravenous saline will be infused with the same volume as the study drug."
11106773|NCT01623531|EG000|Reported Event|RiaSTAP|"Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula~Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)"
11106774|NCT01623531|EG001|Reported Event|Intravenous Saline|"Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula~Placebo: Intravenous placebo will be infused with the same volume as the study drug."
11106775|NCT01623596|BG000|Baseline|Fingolimod|fingolimod 0.5 mg once a day
11106776|NCT01623596|BG001|Baseline|Disease Modifying Therapy (MS_DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
11106777|NCT01623596|BG002|Baseline|Total|Total of all reporting groups
11106778|NCT01623596|FG000|Participant Flow|Fingolimod|fingolimod 0.5 mg once a day
11106779|NCT01623596|FG001|Participant Flow|Disease Modifying Therapy|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
11106780|NCT01623596|OG000|Outcome|Fingolimod|fingolimod 0.5 mg once a day
11106781|NCT01623596|OG001|Outcome|Disease Modifying Therapy (MS-DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
11106782|NCT01623596|OG001|Outcome|Disease Modifying Therapy|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
11106783|NCT01623596|OG001|Outcome|Disease Modifying Therapy (DS-DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
10846803|NCT00280059|FG000|Participant Flow|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
11106784|NCT01623596|EG000|Reported Event|Fingolimod|Fingolimod
11106785|NCT01623596|EG001|Reported Event|MS DMT|MS DMT
11106786|NCT01623739|BG000|Baseline|Type 1 Implant Placement|"Implant is placed immediately following tooth extraction in one surgical procedure~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
11106787|NCT01623739|BG001|Baseline|Type 2 Implant Placement|"Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
11106788|NCT01623739|BG002|Baseline|Total|Total of all reporting groups
11106789|NCT01623739|FG000|Participant Flow|Type 1 Implant Placement|"Implant is placed immediately following tooth extraction in one surgical procedure~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
11106790|NCT01623739|FG001|Participant Flow|Type 2 Implant Placement|"Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
11106791|NCT01623739|OG000|Outcome|Type 1 Implant Placement|"Implant is placed immediately following tooth extraction in one surgical procedure~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
11106792|NCT01623739|OG001|Outcome|Type 2 Implant Placement|"Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
11106793|NCT01623739|OG000|Outcome|Radiographic Bone Level|Radiography is used to measure amount of bone
11106794|NCT01623739|EG000|Reported Event|Type 1 Implant Placement|"Implant is placed immediately following tooth extraction in one surgical procedure~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
11106795|NCT01623739|EG001|Reported Event|Type 2 Implant Placement|"Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
11106796|NCT01623752|BG000|Baseline|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106797|NCT01623752|BG001|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106798|NCT01623752|BG002|Baseline|Participants With Unclear Diagnosis|Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106799|NCT01623752|BG003|Baseline|Total|Total of all reporting groups
11106800|NCT01623752|FG000|Participant Flow|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106801|NCT01623752|FG001|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106802|NCT01623752|FG002|Participant Flow|Participants With Unclear Diagnosis|Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106803|NCT01623752|OG000|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106804|NCT01623752|OG001|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106805|NCT01623752|OG000|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106806|NCT01623752|OG002|Outcome|Participants With Unclear Diagnosis|Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106807|NCT01623752|EG000|Reported Event|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11126604|NCT01734434|OG001|Outcome|Maternal Subjects (Panama)|Pregnant women who were enrolled in Panama.
11126605|NCT01734434|OG002|Outcome|Maternal Subjects (South Africa)|Pregnant women who were enrolled in South Africa.
11126606|NCT01734434|OG003|Outcome|Maternal Subjects (Mozambique)|Pregnant women who were enrolled in Mozambique.
11106808|NCT01623752|EG001|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106809|NCT01623752|EG002|Reported Event|Participants With Unclear Diagnosis|Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
11106810|NCT01623830|BG000|Baseline|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
11106811|NCT01623830|BG001|Baseline|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
11106812|NCT01623830|BG002|Baseline|Total|Total of all reporting groups
11106813|NCT01623830|FG000|Participant Flow|Reactivation + VRE|"Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.~Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
11106814|NCT01623830|FG001|Participant Flow|Neutral Cue + VRE|"VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.~Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
11106815|NCT01623830|OG000|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
11106816|NCT01623830|OG001|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
11106817|NCT01623830|EG000|Reported Event|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
11106818|NCT01623830|EG001|Reported Event|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
11106819|NCT01623869|BG000|Baseline|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11106820|NCT01623869|FG000|Participant Flow|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11106821|NCT01623869|OG000|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11106822|NCT01623869|EG000|Reported Event|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11106823|NCT01624090|BG000|Baseline|Dose Level 1 - 30 mcg/kg Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity."
11106824|NCT01624090|BG001|Baseline|Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity."
11106825|NCT01624090|BG002|Baseline|Dose Level -1 - 25 mcg/kg Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle)."
11106826|NCT01624090|BG003|Baseline|Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle)."
11106827|NCT01624090|BG004|Baseline|Total|Total of all reporting groups
11106828|NCT01624090|FG000|Participant Flow|Dose Level 1 - 30 mcg/kg Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity."
11106829|NCT01624090|FG001|Participant Flow|Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity."
11106830|NCT01624090|FG002|Participant Flow|Dose Level -1 - 25 mcg/kg Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle)."
11106831|NCT01624090|FG003|Participant Flow|Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle)."
11106832|NCT01624090|OG000|Outcome|Dose Level 1 - 30 mcg/kg Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity."
11106833|NCT01624090|OG001|Outcome|Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity."
11106834|NCT01624090|OG002|Outcome|Dose Level -1 - 25 mcg/kg Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle)."
11106835|NCT01624090|OG003|Outcome|Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle)."
11106836|NCT01624090|EG000|Reported Event|Dose Level 1 - 30 mcg/kg Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity."
11106837|NCT01624090|EG001|Reported Event|Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity."
11106838|NCT01624090|EG002|Reported Event|Dose Level -1 - 25 mcg/kg Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle)."
11106839|NCT01624090|EG003|Reported Event|Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy|"Single agent intravenous (IV) mithramycin~Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle)."
11106840|NCT01624142|BG000|Baseline|HoFH|Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
11106841|NCT01624142|BG001|Baseline|Severe FH|Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
11106842|NCT01624142|BG002|Baseline|Total|Total of all reporting groups
11106843|NCT01624142|FG000|Participant Flow|HoFH|Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
11106844|NCT01624142|FG001|Participant Flow|Severe FH|Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
11106845|NCT01624142|OG000|Outcome|HoFH|Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
11106846|NCT01624142|OG001|Outcome|Severe FH|Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
11106847|NCT01624142|EG000|Reported Event|HoFH|Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
11106848|NCT01624142|EG001|Reported Event|Severe FH|Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
11106849|NCT01624142|EG002|Reported Event|Total|Participants received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
11106850|NCT01624168|BG000|Baseline|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
11106851|NCT01624168|BG001|Baseline|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
11106852|NCT01624168|BG002|Baseline|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
11106853|NCT01624168|BG003|Baseline|Total|Total of all reporting groups
11106854|NCT01624168|FG000|Participant Flow|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
11106855|NCT01624168|FG001|Participant Flow|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
11126607|NCT01734434|OG000|Outcome|Maternal Subjects(Dominican Republic)|pregnant women who were enrolled in Dominican Republic.
11106856|NCT01624168|FG002|Participant Flow|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
11106857|NCT01624168|OG000|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
11106858|NCT01624168|OG001|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
11106859|NCT01624168|OG002|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
11106860|NCT01624168|EG000|Reported Event|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
11106861|NCT01624168|EG001|Reported Event|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
11106862|NCT01624168|EG002|Reported Event|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
11106863|NCT01624194|BG000|Baseline|Oxytocin Nasal Spray|Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
11106864|NCT01624194|BG001|Baseline|Placebo Nasal Spray|Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
11106865|NCT01624194|BG002|Baseline|Total|Total of all reporting groups
11106866|NCT01624194|FG000|Participant Flow|Oxytocin Nasal Spray|Oxytocin nasal spray: 24IU twice daily (BID) (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
11106867|NCT01624194|FG001|Participant Flow|Placebo Nasal Spray|Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
11106868|NCT01624194|OG000|Outcome|Oxytocin Nasal Spray|Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
11106869|NCT01624194|OG001|Outcome|Placebo Nasal Spray|Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
11106870|NCT01624194|OG000|Outcome|Oxytocin Nasal Spray|Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice
11106871|NCT01624194|EG000|Reported Event|Oxytocin Nasal Spray|Oxytocin nasal spray: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice for 4-weeks.
11106872|NCT01624194|EG001|Reported Event|Placebo Nasal Spray|Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
10846804|NCT00280059|FG001|Participant Flow|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
11106873|NCT01624233|BG000|Baseline|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
11106874|NCT01624233|FG000|Participant Flow|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).~Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks."
11106875|NCT01624233|OG000|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
11106876|NCT01624233|OG000|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).~Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks."
11106877|NCT01624233|EG000|Reported Event|LY2439821 80mg-Combined Induction and Maintenance Periods|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
11106878|NCT01624233|EG001|Reported Event|LY2439821 80mg-Drug-Free Period|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
11126608|NCT01734434|OG001|Outcome|Maternal Subjects(Panama)|pregnant women who were enrolled in Panama.
11126609|NCT01734434|OG002|Outcome|Maternal Subjects (South Africa)|pregnant women who were enrolled in South Africa.
11004653|NCT01077310|OG000|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
11004654|NCT01077310|OG001|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
11004655|NCT01077310|OG002|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
11004656|NCT01077310|OG003|Outcome|Placebo, Received 4-6 Injections|
11004657|NCT01077310|EG000|Reported Event|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
11004658|NCT01077310|EG001|Reported Event|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
11004659|NCT01077323|BG000|Baseline|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
11004660|NCT01077323|BG001|Baseline|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
11004661|NCT01077323|BG002|Baseline|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
11004662|NCT01077323|BG003|Baseline|Total|Total of all reporting groups
11004663|NCT01077323|FG000|Participant Flow|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
11004664|NCT01077323|FG001|Participant Flow|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
11004665|NCT01077323|FG002|Participant Flow|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
11004666|NCT01077323|OG000|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
11004667|NCT01077323|OG001|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
11004668|NCT01077323|OG002|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
11004669|NCT01077323|EG000|Reported Event|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
11004670|NCT01077323|EG001|Reported Event|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
11106879|NCT01624233|EG002|Reported Event|LY2439821 80mg-Retreatment Period|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
11106880|NCT01624233|EG003|Reported Event|LY2439821 80mg-Post-Treatment Follow-Up Period|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
11106881|NCT01624259|BG000|Baseline|LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
11106882|NCT01624259|BG001|Baseline|Liraglutide|"Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
11106883|NCT01624259|BG002|Baseline|Total|Total of all reporting groups
11106884|NCT01624259|FG000|Participant Flow|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
11106885|NCT01624259|FG001|Participant Flow|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
11106886|NCT01624259|OG000|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
11106887|NCT01624259|OG001|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
11106888|NCT01624259|OG000|Outcome|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
11106889|NCT01624259|OG001|Outcome|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
11106890|NCT01624259|EG000|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
11106891|NCT01624259|EG001|Reported Event|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
11106892|NCT01624350|BG000|Baseline|Permacol Collagen Paste|
11106893|NCT01624350|FG000|Participant Flow|Permacol Collagen Paste|
11106894|NCT01624350|OG000|Outcome|Permacol Collagen Paste|
11106895|NCT01624350|OG000|Outcome|Permacol Collagen Paste - 3 Month Follow up|
11106896|NCT01624350|OG001|Outcome|Permacol Collagen Paste - 12 Month Follow up|
11106897|NCT01624350|OG000|Outcome|Baseline - Pre-operatively|
11106898|NCT01624350|OG001|Outcome|Permacol Collagen Paste - 3 Month Post-op|
11106899|NCT01624350|OG002|Outcome|Permacol Collagen Paste - 6 Month Post-op|
11106900|NCT01624350|OG003|Outcome|Permacol Collagen Paste - 12 Month Post-op|
11106901|NCT01624350|OG000|Outcome|Permacol Collagen Paste - 3 Month Post-op|
11106902|NCT01624350|OG001|Outcome|Permacol Collagen Paste - 6 Month Post-op|
11106903|NCT01624350|OG002|Outcome|Permacol Collagen Paste - 12 Month Post-op|
11106904|NCT01624350|OG000|Outcome|First Visit|
11106905|NCT01624350|OG001|Outcome|Last Visit|
11106906|NCT01624350|OG000|Outcome|Baseline|
11106907|NCT01624350|OG001|Outcome|Permacol Collagen Paste - 1 Month Post-op|
11106908|NCT01624350|OG002|Outcome|Permacol Collagen Paste - 3 Month Post-op|
11106909|NCT01624350|OG003|Outcome|Permacol Collagen Paste - 6 Month Post-op|
11106910|NCT01624350|OG004|Outcome|Permacol Collagen Paste - 12 Month Post-op|
11106911|NCT01624350|EG000|Reported Event|Permacol Collagen Paste|
11106912|NCT01624363|BG000|Baseline|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
11106913|NCT01624363|FG000|Participant Flow|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
11106914|NCT01624363|OG000|Outcome|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
11106915|NCT01624363|EG000|Reported Event|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
11106916|NCT01624467|BG000|Baseline|Necitumumab|800 mg necitumumab, administered once per week IV
11106917|NCT01624467|FG000|Participant Flow|Necitumumab|800 milligram (mg) necitumumab, administered once per week as an intravenous infusion (IV)
11106918|NCT01624467|OG000|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
11106919|NCT01624467|OG000|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
11106920|NCT01624467|OG001|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
11106921|NCT01624467|EG000|Reported Event|Necitumumab|800 mg necitumumab, administered once per week as an intravenous infusion (IV)
11106922|NCT01624506|BG000|Baseline|Magnetic Sphincter Augmentation|Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
11106923|NCT01624506|BG001|Baseline|Fundoplication|Patients treated with laparoscopic fundoplication
11106924|NCT01624506|BG002|Baseline|Total|Total of all reporting groups
11106925|NCT01624506|FG000|Participant Flow|Magnetic Sphincter Augmentation|Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
11106926|NCT01624506|FG001|Participant Flow|Fundoplication|Patients treated with laparoscopic fundoplication
11106927|NCT01624506|OG000|Outcome|Magnetic Sphincter Augmentation|Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
11106928|NCT01624506|OG001|Outcome|Fundoplication|Patients treated with laparoscopic fundoplication
11106929|NCT01624506|EG000|Reported Event|Magnetic Sphincter Augmentation|Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
11106930|NCT01624506|EG001|Reported Event|Fundoplication|Patients treated with laparoscopic fundoplication
11106931|NCT01624662|BG000|Baseline|Placebo|Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks
11106932|NCT01624662|BG001|Baseline|OPN-375 100 mcg|OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks
11106933|NCT01624662|BG002|Baseline|OPN-375 200 mcg|OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks
11106934|NCT01624662|BG003|Baseline|OPN-375 400 mcg|OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks
11106935|NCT01624662|BG004|Baseline|Total|Total of all reporting groups
11106936|NCT01624662|FG000|Participant Flow|Placebo|Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
11106937|NCT01624662|FG001|Participant Flow|OPN-375 100 mcg|OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
11106938|NCT01624662|FG002|Participant Flow|OPN-375 200 mcg|OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
11106939|NCT01624662|FG003|Participant Flow|OPN-375 400 mcg|OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
11106940|NCT01624662|OG000|Outcome|Placebo|Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
11106941|NCT01624662|OG001|Outcome|OPN-375 100 mcg|OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
11106942|NCT01624662|OG002|Outcome|OPN-375 200 mcg|OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
11106943|NCT01624662|OG003|Outcome|OPN-375 400 mcg|OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
11106944|NCT01624662|OG002|Outcome|OPN 375 200 mcg|OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
11106945|NCT01624662|OG003|Outcome|OPN 375 400 mcg|OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
11106946|NCT01624662|OG000|Outcome|Placebo|Matched placebo BID x 16 weeks
11106947|NCT01624662|OG001|Outcome|100 mcg Fluticasone Proprionate|100 mcg fluticasone propionate BID x 16 weeks
11106948|NCT01624662|OG002|Outcome|200 mcg Fluticasone Proprionate|200 mcg fluticasone propionate BID x 16 weeks
11106949|NCT01624662|OG003|Outcome|400 mcg Fluticasone Prioprionate|400 mcg fluticasone propionate BID x 16 weeks
11106950|NCT01624662|OG000|Outcome|Placebo|Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
11106951|NCT01624662|OG001|Outcome|OPN-375 100 mcg|OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
11106952|NCT01624662|OG002|Outcome|OPN-375 200 mcg|OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
11106953|NCT01624662|OG003|Outcome|OPN-375 400 mcg|OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
11106954|NCT01624662|EG000|Reported Event|Placebo (Double-blind Phase)|Matched placebo BID x 16 weeks
11106955|NCT01624662|EG001|Reported Event|OPN-375 100 mcg (Double-blind Phase)|OPN-375 100 mcg BID x 16 weeks
11106956|NCT01624662|EG002|Reported Event|OPN-375 200 mcg (Double-blind Phase)|OPN-375 200 mcg BID x 16 weeks
11106957|NCT01624662|EG003|Reported Event|OPN-375 400 mcg (Double-blind Phase)|OPN-375 400 mcg BID x 16 weeks
11106958|NCT01624662|EG004|Reported Event|OPN-375 400 mcg (Open-label Phase)|OPN-375 400 mcg (open-label) BID x 8 weeks
11106959|NCT01624870|BG000|Baseline|All Enrolled|All subjects enrolled in the study
11106960|NCT01624870|FG000|Participant Flow|All Enrolled|All subjects who enrolled in the study
11106961|NCT01624870|OG000|Outcome|CoreValve Implant Depth ≤6mm|Enrolled subjects implanted with a CoreValve device at an implant depth of ≤6mm
11106962|NCT01624870|OG001|Outcome|CoreValve Implant Depth >6mm|Enrolled subjects with a CoreVavle device at an implant depth of >6mm
11106963|NCT01624870|OG000|Outcome|All Implanted|All subjects who were implanted with the CoreValve device. All subjects in whom the procedure was attempted were implanted with the CoreVave device.
11106964|NCT01624870|EG000|Reported Event|All Implanted|All subjects who were implanted with the CoreValve device. All subjects in whom the procedure was attempted were implanted with the CoreVave device.
11106965|NCT01624740|BG000|Baseline|Low Rate Followed By High Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
11106966|NCT01624740|BG001|Baseline|High Rate Followed By Low Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
11106967|NCT01624740|BG002|Baseline|Total|Total of all reporting groups
11106968|NCT01624740|FG000|Participant Flow|Low Rate Followed By High Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
11106969|NCT01624740|FG001|Participant Flow|High Rate Followed By Low Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
11106970|NCT01624740|OG000|Outcome|Low Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 2 Hz as either a first or second intervention.
11106971|NCT01624740|OG001|Outcome|High Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 1200 Hz as either a first or second intervention.
11106972|NCT01624740|EG000|Reported Event|Trial Lead Insertion|All subjects (n = 20) underwent a lead insertion procedure prior to beginning Period 1 of stimulation. Two of these subjects did not proceed to Period 1 due to insertion difficulties.
11106973|NCT01624740|EG001|Reported Event|Low Frequency Stimulation|Stimulation was given at 2 Hz.
11106974|NCT01624740|EG002|Reported Event|High Frequency Stimulation|Stimulation was given at 1200 Hz.
11106975|NCT01624948|BG000|Baseline|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
11106976|NCT01624948|BG001|Baseline|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
11106977|NCT01624948|BG002|Baseline|Total|Total of all reporting groups
11106978|NCT01624948|FG000|Participant Flow|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo mycophenolic acid (MPA) discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
11106979|NCT01624948|FG001|Participant Flow|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BK polyomavirus (BKV) infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
11106980|NCT01624948|OG000|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
11106981|NCT01624948|OG001|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
11106982|NCT01624948|OG000|Outcome|Reached Primary Endpoint|>50% reduction of BKV viruria and/or clearance of BKV viremia
11106983|NCT01624948|OG001|Outcome|Failed to Reach Primary Endpoint|
11106984|NCT01624948|OG000|Outcome|Rejection|Any biopsy-proven rejection episode
11106985|NCT01624948|OG001|Outcome|No Rejection|No biopsy-proven rejection episode
11106986|NCT01624948|EG000|Reported Event|Everolimus+Tacrolimus/Prednisone|Everolimus: MPA discontinuation with the addition of Zortress (everolimus) to current regimen of tacrolimus and prednisone; Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
11106987|NCT01624948|EG001|Reported Event|Standard of Care: 50% Reduction of MPA|Mycophenolic acid dose reduction: continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
11106988|NCT01624974|BG000|Baseline|MK-1029 150 mg + ML → Placebo + ML|Participants received 4 weeks of MK-1029 150 mg QD + ML 10 mg QD in Period III and Placebo + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
11126610|NCT01734434|OG003|Outcome|Maternal Subjects(Mozambique)|pregnant women who were enrolled in Mozambique.
11126611|NCT01734434|OG000|Outcome|Infants (Dominican Republic)|Infants born to pregnant women who were enrolled in Dominican Republic, brought to study site for 90-day follow up.
11004671|NCT01077323|EG002|Reported Event|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
11004672|NCT01077362|BG000|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
11004673|NCT01077362|BG001|Baseline|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
11004674|NCT01077362|BG002|Baseline|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
11004675|NCT01077362|BG003|Baseline|Total|Total of all reporting groups
11004676|NCT01077362|FG000|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
11004677|NCT01077362|FG001|Participant Flow|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
11004678|NCT01077362|FG002|Participant Flow|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
11004679|NCT01077362|OG000|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
11004680|NCT01077362|OG001|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
11004681|NCT01077362|OG002|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
11004682|NCT01077362|OG003|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
11004683|NCT01077362|EG000|Reported Event|Placebo: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
11004684|NCT01077362|EG001|Reported Event|Ustekinumab 45 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
11004685|NCT01077362|EG002|Reported Event|Ustekinumab 90 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
11004686|NCT01077362|EG003|Reported Event|Placebo: Weeks 16-24|Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16.
11004687|NCT01077362|EG004|Reported Event|Placebo -> Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
11004688|NCT01077362|EG005|Reported Event|Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
11004689|NCT01077362|EG006|Reported Event|Ustekinumab 90 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
11004690|NCT01077375|BG000|Baseline|Placebo|Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
11004691|NCT01077375|BG001|Baseline|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration.~One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population."
11004692|NCT01077375|BG002|Baseline|Total|Total of all reporting groups
11004693|NCT01077375|FG000|Participant Flow|Placebo|Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
11004694|NCT01077375|FG001|Participant Flow|Milnacipran|Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration.
11004695|NCT01077375|OG000|Outcome|Placebo|Intent-to-treat (ITT) Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
11004696|NCT01077375|OG001|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
11004697|NCT01077375|OG000|Outcome|Placebo|Intent-to-treat Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
11004698|NCT01077375|OG001|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)"
11004699|NCT01077375|EG000|Reported Event|Placebo|Double-blind Safety Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
11004700|NCT01077375|EG001|Reported Event|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
11004701|NCT01077401|BG000|Baseline|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
11004702|NCT01077401|BG001|Baseline|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
11004703|NCT01077401|BG002|Baseline|Total|Total of all reporting groups
11004704|NCT01077401|FG000|Participant Flow|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
11004705|NCT01077401|FG001|Participant Flow|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
11004706|NCT01077401|OG000|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
11004707|NCT01077401|OG001|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
11004708|NCT01077401|EG000|Reported Event|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
11004709|NCT01077401|EG001|Reported Event|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
11004710|NCT01077518|BG000|Baseline|Ofa + Benda (Arm A)|ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days
11004711|NCT01077518|BG001|Baseline|Benda (Arm B)|Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
11004712|NCT01077518|BG002|Baseline|Total|Total of all reporting groups
11004713|NCT01077518|FG000|Participant Flow|Ofa + Benda (Arm A)|ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days
11004714|NCT01077518|FG001|Participant Flow|Benda (Arm B)|Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
11004715|NCT01077518|FG002|Participant Flow|Optional Ofa|Participants from the Benda arm who opted for optional ofatumumab therapy post disease progression.
11004716|NCT01077518|OG000|Outcome|Ofa + Benda (Arm A)|ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days
11004717|NCT01077518|OG001|Outcome|Benda (Arm B)|Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
11004718|NCT01077518|OG000|Outcome|Optional Ofa|Eligible benda arm participants who were offered optional ofatumumab following disease progression
11126612|NCT01734434|OG001|Outcome|Infants (Panama)|Infants born to pregnant women who were enrolled in Panama, brought to study site for 90-day follow up.
11004719|NCT01077518|EG000|Reported Event|Ofa + Benda (Arm A)|ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days
11004720|NCT01077518|EG001|Reported Event|Benda (Arm B)|Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
11004721|NCT01077518|EG002|Reported Event|Optional Ofa|Eligible benda arm participants who were offered optional ofatumumab following disease progression
11004722|NCT01077518|EG003|Reported Event|Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa|All participants in the Ofa + Benda arm and in the Benda only arm
11004723|NCT01077544|BG000|Baseline|Group 1|1 year to < 10 years pediatric patients
11004724|NCT01077544|BG001|Baseline|Group 2|>= 10 years to <18 years pediatric patients
11004725|NCT01077544|BG002|Baseline|Total|Total of all reporting groups
11004726|NCT01077544|FG000|Participant Flow|Group 1|1 year to < 10 years pediatric patients
11004727|NCT01077544|FG001|Participant Flow|Group 2|>= 10 years to <18 years pediatric patients
11004728|NCT01077544|OG000|Outcome|Group 1|1 year to < 10 years pediatric patients
11004729|NCT01077544|OG001|Outcome|Group 2|>= 10 years to <18 years pediatric patients
11004730|NCT01077544|EG000|Reported Event|Group 1|1 year to < 10 years pediatric patients
11004731|NCT01077544|EG001|Reported Event|Group 2|>= 10 years to <18 years pediatric patients
11004732|NCT01077596|BG000|Baseline|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
11004733|NCT01077596|BG001|Baseline|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
11004734|NCT01077596|BG002|Baseline|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
11004735|NCT01077596|BG003|Baseline|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
11004736|NCT01077596|BG004|Baseline|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
11004737|NCT01077596|BG005|Baseline|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
11004738|NCT01077596|BG006|Baseline|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
11004739|NCT01077596|BG007|Baseline|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
11004740|NCT01077596|BG008|Baseline|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
11004741|NCT01077596|BG009|Baseline|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
11004742|NCT01077596|BG010|Baseline|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
11004743|NCT01077596|BG011|Baseline|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
11004744|NCT01077596|BG012|Baseline|Total|Total of all reporting groups
11004745|NCT01077596|FG000|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
11004746|NCT01077596|FG001|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
11004747|NCT01077596|FG002|Participant Flow|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
11004748|NCT01077596|FG003|Participant Flow|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
11004749|NCT01077596|FG004|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
11004750|NCT01077596|FG005|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
11004751|NCT01077596|FG006|Participant Flow|Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
11004752|NCT01077596|FG007|Participant Flow|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
11004753|NCT01077596|FG008|Participant Flow|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
11004754|NCT01077596|FG009|Participant Flow|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
11004755|NCT01077596|FG010|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
11004756|NCT01077596|FG011|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
11004757|NCT01077596|OG000|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
11126613|NCT01734434|OG002|Outcome|Infants (South Africa)|Infants born to pregnant women who were enrolled in South Africa, brought to study site for 90-day follow up.
11004758|NCT01077596|OG001|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
11004759|NCT01077596|OG002|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
11004760|NCT01077596|OG003|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
11004761|NCT01077596|OG004|Outcome|Other Antidepressants, Regular Use|"Regular other antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date"
11106989|NCT01624974|BG001|Baseline|Placebo + ML → MK-1029 150 mg + ML|Participants received 4 weeks of Placebo QD + ML 10 mg QD in Period III and MK-1029 150 mg QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
11106990|NCT01624974|BG002|Baseline|Total|Total of all reporting groups
11004762|NCT01077596|OG002|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
11004763|NCT01077596|OG004|Outcome|Other Antidepressants, Regular Use|Regular 'other' antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
11004764|NCT01077596|EG000|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
11004765|NCT01077596|EG001|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
11004766|NCT01077596|EG002|Reported Event|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
11004767|NCT01077596|EG003|Reported Event|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
11004768|NCT01077596|EG004|Reported Event|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
11004769|NCT01077596|EG005|Reported Event|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
11004770|NCT01077596|EG006|Reported Event|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
11004771|NCT01077596|EG007|Reported Event|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
11004772|NCT01077596|EG008|Reported Event|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
11004773|NCT01077596|EG009|Reported Event|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
11004774|NCT01077596|EG010|Reported Event|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
11004775|NCT01077596|EG011|Reported Event|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
11004776|NCT01077622|BG000|Baseline|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
11004777|NCT01077622|FG000|Participant Flow|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
11004778|NCT01077622|OG000|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
11004779|NCT01077622|EG000|Reported Event|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
11004780|NCT01077713|BG000|Baseline|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
11004781|NCT01077713|BG001|Baseline|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
11004782|NCT01077713|BG002|Baseline|Total|Total of all reporting groups
11004783|NCT01077713|FG000|Participant Flow|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
11004784|NCT01077713|FG001|Participant Flow|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
11004785|NCT01077713|OG000|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
11004786|NCT01077713|OG001|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
11004787|NCT01077713|EG000|Reported Event|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
11004788|NCT01077713|EG001|Reported Event|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
11004789|NCT01077739|BG000|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
11004790|NCT01077739|BG001|Baseline|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
11004791|NCT01077739|BG002|Baseline|Total|Total of all reporting groups
11004792|NCT01077739|FG000|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1; oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1; and capecitabine 1000 mg/m^2, orally (PO), twice daily (BID) on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
11004793|NCT01077739|FG001|Participant Flow|Bevacizumab + 5-fluorouracil/Oxaliplatin/Leucovorin (FOLFOX)|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-fluorouracil [5-FU] plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
11004794|NCT01077739|OG000|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
11004795|NCT01077739|OG001|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
11004796|NCT01077739|EG000|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
11004797|NCT01077739|EG001|Reported Event|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
11004798|NCT01077804|BG000|Baseline|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
11004799|NCT01077804|FG000|Participant Flow|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
11004800|NCT01077804|OG000|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
11004801|NCT01077804|EG000|Reported Event|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
11004802|NCT01077856|BG000|Baseline|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
11004803|NCT01077856|BG001|Baseline|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
11004804|NCT01077856|BG002|Baseline|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
11004805|NCT01077856|BG003|Baseline|Total|Total of all reporting groups
11004806|NCT01077856|FG000|Participant Flow|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
11004807|NCT01077856|FG001|Participant Flow|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
11004808|NCT01077856|FG002|Participant Flow|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
11004809|NCT01077856|OG000|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
11004810|NCT01077856|OG001|Outcome|Denmark Participants 2007, After Gardasil Licensure|
11004811|NCT01077856|OG002|Outcome|Denmark Participants 2008 After Gardasil Licensure|
11004812|NCT01077856|OG003|Outcome|Denmark Participants 2009 After Gardasil Licensure|
11004813|NCT01077856|OG004|Outcome|Denmark Participants 2010 After Gardasil Licensure|
11004814|NCT01077856|OG005|Outcome|Denmark Participants 2011 After Gardasil Licensure|
11004815|NCT01077856|OG000|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
11004816|NCT01077856|OG001|Outcome|Norway Participants 2007, After Gardasil Licensure|
11004817|NCT01077856|OG002|Outcome|Norway Participants 2008 After Gardasil Licensure|
11004818|NCT01077856|OG003|Outcome|Norway Participants 2009 After Gardasil Licensure|
11004819|NCT01077856|OG004|Outcome|Norway Participants 2010 After Gardasil Licensure|
11004820|NCT01077856|OG005|Outcome|Norway Participants 2011 After Gardasil Licensure|
11004821|NCT01077856|OG000|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
11004822|NCT01077856|OG001|Outcome|Sweden Participants 2007, After Gardasil Licensure|
11004823|NCT01077856|OG002|Outcome|Sweden Participants 2008 After Gardasil Licensure|
11004824|NCT01077856|OG003|Outcome|Sweden Participants 2009 After Gardasil Licensure|
11004825|NCT01077856|OG004|Outcome|Sweden Participants 2010 After Gardasil Licensure|
11004826|NCT01077856|OG005|Outcome|Sweden Participants 2011 After Gardasil Licensure|
11004827|NCT01077856|OG001|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
11004828|NCT01077856|OG002|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
11004829|NCT01077856|OG003|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
11004830|NCT01077856|OG004|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
11004831|NCT01077856|OG005|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
11004832|NCT01077856|OG000|Outcome|Babies Born to Denmark Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Denmark participants who received Gardasil during pregnancy
11004833|NCT01077856|OG001|Outcome|Babies Born to Denmark Participants|Live babies born between 2007 and 2011 to Denmark participants in the general population, including participants who did and did not receive Gardasil
11004834|NCT01077856|OG002|Outcome|Babies Born to Norway Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Norway participants who received Gardasil during pregnancy
11004835|NCT01077856|OG003|Outcome|Babies Born to Norway Participants|Live babies born between 2007 and 2011 to Norway participants in the general population, including participants who did and did not receive Gardasil
11004836|NCT01077856|OG004|Outcome|Babies Born to Sweden Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Sweden participants who received Gardasil during pregnancy
11004837|NCT01077856|OG005|Outcome|Babies Born to Sweden Participants|Live babies born between 2007 and 2011 to Sweden participants in the general population, including participants who did and did not received Gardasil
11004838|NCT01077856|OG000|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
11004839|NCT01077856|OG001|Outcome|Denmark Participants Who Did Not Receive Gardasil|
11004840|NCT01077856|OG002|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
11004841|NCT01077856|OG003|Outcome|Norway Participants Who Did Not Receive Gardasil|
11004842|NCT01077856|OG004|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
11004843|NCT01077856|OG005|Outcome|Sweden Participants Who Did Not Receive Gardasil|
11004844|NCT01077856|EG000|Reported Event|Denmark Participants|All Denmark study participants
11004845|NCT01077856|EG001|Reported Event|Norway Participants|All Norway study participants
11004846|NCT01077856|EG002|Reported Event|Sweden Participants|All Sweden study participants
11004847|NCT01077921|BG000|Baseline|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
11004848|NCT01077921|BG001|Baseline|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period
11004849|NCT01077921|BG002|Baseline|Total|Total of all reporting groups
11004850|NCT01077921|FG000|Participant Flow|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
11004851|NCT01077921|FG001|Participant Flow|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period.
11004852|NCT01077921|OG000|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
11004853|NCT01077921|OG001|Outcome|Placebo|All subjects completing the placebo treatment phase.
11004854|NCT01077921|OG001|Outcome|Placebo|All subjects completing placebo treatment phase.
11126614|NCT01734434|OG003|Outcome|Infants (Mozambique)|Infants born to pregnant women who were enrolled in Mozambique, brought to study site for 90-day follow up.
11004855|NCT01077921|EG000|Reported Event|Propranolol|Propranolol: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
11004856|NCT01077921|EG001|Reported Event|Placebo|Placebo: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
11004857|NCT01077960|BG000|Baseline|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
11004858|NCT01077960|FG000|Participant Flow|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
11004859|NCT01077960|OG000|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
11004860|NCT01077960|EG000|Reported Event|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
11004861|NCT01077973|BG000|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004862|NCT01077973|BG001|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11004863|NCT01077973|BG002|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004864|NCT01077973|BG003|Baseline|Total|Total of all reporting groups
11004865|NCT01077973|FG000|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004866|NCT01077973|FG001|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11004867|NCT01077973|FG002|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004868|NCT01077973|OG000|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004869|NCT01077973|OG001|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11004870|NCT01077973|OG000|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11004871|NCT01077973|OG001|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004872|NCT01077973|OG002|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004873|NCT01077973|EG000|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004874|NCT01077973|EG001|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11004875|NCT01077973|EG002|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11004876|NCT01078090|BG000|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
11004877|NCT01078090|FG000|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
11004878|NCT01078090|OG000|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
11004879|NCT01078090|OG000|Outcome|Month 0|Baseline
11004880|NCT01078090|OG001|Outcome|Month 3|3 months after inclusion
11004881|NCT01078090|OG002|Outcome|Month 6|6 months after inclusion
11004882|NCT01078090|OG003|Outcome|Month 12|12 months after inclusion
11004883|NCT01078090|OG004|Outcome|Month 18|18 months after inclusion
11004884|NCT01078090|OG005|Outcome|Month 24|24 months after inclusion
11004885|NCT01078090|OG006|Outcome|Month 30|30 months after inclusion
11004886|NCT01078090|OG007|Outcome|Month 36|36 months after inclusion
11004887|NCT01078090|OG008|Outcome|Month 48|48 months after inclusion
11004888|NCT01078090|OG009|Outcome|Month 60|60 months after inclusion
11004889|NCT01078090|OG001|Outcome|Month 6|6 months after inclusion
11004890|NCT01078090|OG002|Outcome|Month 18|18 months after inclusion
11004891|NCT01078090|OG003|Outcome|Month 24|24 months after inclusion
11004892|NCT01078090|OG004|Outcome|Month 30|30 months after inclusion
11004893|NCT01078090|EG000|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
11004894|NCT01078116|BG000|Baseline|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
11004895|NCT01078116|FG000|Participant Flow|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
11004896|NCT01078116|OG000|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
11004897|NCT01078116|EG000|Reported Event|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
11004898|NCT01078155|BG000|Baseline|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
11004899|NCT01078155|FG000|Participant Flow|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-tumor necrosis factor (TNF) was taken prior to a participant's enrollment in the study.
11004900|NCT01078155|OG000|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
11004901|NCT01078155|EG000|Reported Event|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
11004902|NCT01078168|BG000|Baseline|Acitretin|"oral, 30 mg per day, day 1-28~Acitretin: 30mg per day from Day 1 to Day 28"
11004903|NCT01078168|BG001|Baseline|Placebo|"oral, day 1-28~Placebo: Placebo"
11004904|NCT01078168|BG002|Baseline|Total|Total of all reporting groups
11004905|NCT01078168|FG000|Participant Flow|Acitretin|"oral, 30 mg per day, day 1-28~Acitretin: 30mg per day from Day 1 to Day 28"
11004906|NCT01078168|FG001|Participant Flow|Placebo|"oral, day 1-28~Placebo: Placebo"
11004907|NCT01078168|OG000|Outcome|Acitretin|"oral, 30 mg per day, day 1-28~Acitretin: 30mg per day from Day 1 to Day 28"
11004908|NCT01078168|OG001|Outcome|Placebo|"oral, day 1-28~Placebo: Placebo"
11004909|NCT01078168|EG000|Reported Event|Acitretin|"oral, 30 mg per day, day 1-28~Acitretin: 30mg per day from Day 1 to Day 28"
11004910|NCT01078168|EG001|Reported Event|Placebo|"oral, day 1-28~Placebo: Placebo"
11004911|NCT01078207|BG000|Baseline|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
11004912|NCT01078207|FG000|Participant Flow|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
11004913|NCT01078207|OG000|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
11004914|NCT01078207|EG000|Reported Event|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
11004915|NCT01078220|BG000|Baseline|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
11004916|NCT01078220|FG000|Participant Flow|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
11004917|NCT01078220|OG000|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
11004918|NCT01078220|OG001|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
11004919|NCT01078220|OG000|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
11004920|NCT01078220|OG000|Outcome|Autoimmune Safety Population|Any female with at least 12 months of membership at a MCO prior to their first dose of Gardasil, in order to exclude pre-existing conditions prior to their first dose of Gardasil.
11004921|NCT01078220|EG000|Reported Event|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
11126615|NCT01734434|EG000|Reported Event|Maternal Subjects (Dominican Republic)|Pregnant women who were enrolled in Dominican Republic.
11004922|NCT01078233|BG000|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
11004923|NCT01078233|BG001|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
11004924|NCT01078233|BG002|Baseline|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
11004925|NCT01078233|BG003|Baseline|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
11004926|NCT01078233|BG004|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
11004927|NCT01078233|BG005|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
11004928|NCT01078233|BG006|Baseline|Total|Total of all reporting groups
11004929|NCT01078233|FG000|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
11004930|NCT01078233|FG001|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
11004931|NCT01078233|FG002|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
11004932|NCT01078233|FG003|Participant Flow|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
11004933|NCT01078233|FG004|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
11004934|NCT01078233|FG005|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
11004935|NCT01078233|OG000|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
11004936|NCT01078233|OG001|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
11004937|NCT01078233|OG002|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
11004938|NCT01078233|EG000|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
11106991|NCT01624974|FG000|Participant Flow|MK-1029 + ML → Placebo + ML|Participants received 4 weeks of MK-1029 150 mg QD + ML 10 mg QD in Period III and Placebo + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.
11106992|NCT01624974|FG001|Participant Flow|Placebo + ML → MK-1029 + ML|Participants received 4 weeks of Placebo QD + ML 10 mg QD in Period III and MK-1029 150 mg QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.
11106993|NCT01624974|OG000|Outcome|MK-1029 + ML|Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
11106994|NCT01624974|OG001|Outcome|Placebo + ML|Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
11106995|NCT01624974|OG001|Outcome|Placebo + ML|Participants received 4 weeks treatment with placebo QD + ML 10 mg QD in Period III or V. Period IV was a 4-week wash-out period during which participants received single-blind placebo QD and open-label ML 10 mg QD.
11106996|NCT01624974|EG000|Reported Event|MK 1029 + ML|Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.
11106997|NCT01624974|EG001|Reported Event|Placebo + ML|Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.
11106998|NCT01625000|BG000|Baseline|MP-214 3mg|MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
11106999|NCT01625000|BG001|Baseline|MP-214 6mg|MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
11107000|NCT01625000|BG002|Baseline|MP-214 9mg|MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
11107001|NCT01625000|BG003|Baseline|Risperidone 4mg|Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
11107002|NCT01625000|BG004|Baseline|Placebo|Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
11107003|NCT01625000|BG005|Baseline|Total|Total of all reporting groups
11107004|NCT01625000|FG000|Participant Flow|MP-214 3mg|MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
11107005|NCT01625000|FG001|Participant Flow|MP-214 6mg|MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
11107006|NCT01625000|FG002|Participant Flow|MP-214 9mg|MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
11107007|NCT01625000|FG003|Participant Flow|Risperidone 4mg|Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
11107008|NCT01625000|FG004|Participant Flow|Placebo|Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
11107009|NCT01625000|OG000|Outcome|MP-214 3mg|MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
11107010|NCT01625000|OG001|Outcome|MP-214 6mg|MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
11107011|NCT01625000|OG002|Outcome|MP-214 9mg|MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
11107012|NCT01625000|OG003|Outcome|Risperidone 4mg|Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
11107013|NCT01625000|OG004|Outcome|Placebo|Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
11107014|NCT01625000|EG000|Reported Event|MP-214 3mg|MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
11107015|NCT01625000|EG001|Reported Event|MP-214 6mg|MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
11107016|NCT01625000|EG002|Reported Event|MP-214 9mg|MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
11107017|NCT01625000|EG003|Reported Event|Risperidone 4mg|Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
11107018|NCT01625000|EG004|Reported Event|Placebo|Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
11107019|NCT01625013|BG000|Baseline|Synvisc-One|Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
11107020|NCT01625013|FG000|Participant Flow|Synvisc-One|Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
11107021|NCT01625013|OG000|Outcome|Synvisc-One|Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
11107022|NCT01625013|OG000|Outcome|Synvisc-One Second Injection|Synvisc-One (G-F 20): Synvisc G-F 20 will be injected a second time in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out until three years from their first injection. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for a total of 3 years.
11107023|NCT01625013|EG000|Reported Event|Synvisc-One|Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
11107024|NCT01625091|BG000|Baseline|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
11107025|NCT01625091|BG001|Baseline|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
11107026|NCT01625091|BG002|Baseline|Total|Total of all reporting groups
11107027|NCT01625091|FG000|Participant Flow|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
11107028|NCT01625091|FG001|Participant Flow|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
11107029|NCT01625091|OG000|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
11107030|NCT01625091|OG001|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
11107031|NCT01625091|EG000|Reported Event|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
11107032|NCT01625091|EG001|Reported Event|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
11107033|NCT01625104|BG000|Baseline|Group 1: Agressive Intervention|"Hospitals were randomized to an aggressive intervention strategy or to business as usual. The hospitals randomized to the aggressive intervention strategy underwent the following:~Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.~Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers~Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing~Written plan from sites detailing plans to change processes of care."
11107034|NCT01625104|BG001|Baseline|Group 2: Control Strategy|"Hospitals randomized to the control group were instructed to conduct business as usual.~Business as usual was described as site specific protocol for treatment of STEMI patient +/- any ongoing quality improvement efforts. No specific recommendations were given to sites from the coordinating center."
11107035|NCT01625104|BG002|Baseline|Total|Total of all reporting groups
11107036|NCT01625104|FG000|Participant Flow|Group 1: Agressive Strategy|"Hospitals were randomized to an aggressive intervention strategy or to business as usual. The hospitals randomized to the aggressive intervention strategy underwent the following:~Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.~Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers~Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing~Written plan from sites detailing plans to change processes of care."
11107037|NCT01625104|FG001|Participant Flow|Group 2: Control|"Hospitals randomized to the control group were instructed to conduct business as usual."
11107038|NCT01625104|OG000|Outcome|Group 1: Aggressive Stategy|
11107039|NCT01625104|OG001|Outcome|Group 2: Control Strategy|"Hospitals randomized to the control group were instructed to conduct business as usual."
11107040|NCT01625104|EG000|Reported Event|Group 1: Agressive Intervention|"Hospitals were randomized to an aggressive intervention strategy or to business as usual. The hospitals randomized to the aggressive intervention strategy underwent the following:~Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.~Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers~Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing~Written plan from sites detailing plans to change processes of care."
11107041|NCT01625104|EG001|Reported Event|Group 2: Control Strategy|"Hospitals randomized to the control group were instructed to conduct business as usual.~Business as usual was defined as normal protocol for treatment of STEMI patients at each individual site +/- quality improvement efforts. No contact or advice was given to the sites from the coordinating center."
11107042|NCT01625169|BG000|Baseline|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.~There is only one arm- all pregnant women enrolled into the study will receive Etravirine 200mg PO bid for 14 days postpartum"
11107043|NCT01625169|FG000|Participant Flow|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
11126616|NCT01734434|EG001|Reported Event|Maternal Subjects (Panama)|Pregnant women who were enrolled in Panama.
11107044|NCT01625169|OG000|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
11107045|NCT01625169|EG000|Reported Event|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
11107046|NCT01625182|BG000|Baseline|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
11107047|NCT01625182|BG001|Baseline|Placebo|Participants received matching placebo to Fingolimod orally once daily.
11107048|NCT01625182|BG002|Baseline|Total|Total of all reporting groups
11107049|NCT01625182|FG000|Participant Flow|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
11107050|NCT01625182|FG001|Participant Flow|Placebo|Participants received matching placebo to Fingolimod orally once daily.
11107051|NCT01625182|OG000|Outcome|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
11107052|NCT01625182|OG001|Outcome|Placebo|Participants received matching placebo to Fingolimod orally once daily.
11107053|NCT01625182|EG000|Reported Event|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
11107054|NCT01625182|EG001|Reported Event|Placebo|Participants received matching placebo to Fingolimod orally once daily.
11107055|NCT01625182|EG002|Reported Event|Overall Participants|
11107056|NCT01625221|BG000|Baseline|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
11107057|NCT01625221|FG000|Participant Flow|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
11107058|NCT01625221|OG000|Outcome|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
11107059|NCT01625221|EG000|Reported Event|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
10846805|NCT00280059|OG000|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
11107060|NCT01625338|BG000|Baseline|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11107061|NCT01625338|BG001|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11107062|NCT01625338|BG002|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
11107063|NCT01625338|BG003|Baseline|Total|Total of all reporting groups
11107064|NCT01625338|FG000|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11107065|NCT01625338|FG001|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11107066|NCT01625338|FG002|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
11107067|NCT01625338|OG000|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11107068|NCT01625338|OG001|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11107069|NCT01625338|OG002|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
11107070|NCT01625338|EG000|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11107071|NCT01625338|EG001|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11107072|NCT01625338|EG002|Reported Event|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
11107073|NCT01625377|BG000|Baseline|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
11107074|NCT01625377|BG001|Baseline|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
11107075|NCT01625377|BG002|Baseline|Total|Total of all reporting groups
11107076|NCT01625377|FG000|Participant Flow|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
11107077|NCT01625377|FG001|Participant Flow|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
11107078|NCT01625377|OG000|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
11107079|NCT01625377|OG001|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
11107080|NCT01625377|EG000|Reported Event|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
11107081|NCT01625377|EG001|Reported Event|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
11107082|NCT01625416|BG000|Baseline|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
11107083|NCT01625416|BG001|Baseline|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
11107084|NCT01625416|BG002|Baseline|Total|Total of all reporting groups
11107085|NCT01625416|FG000|Participant Flow|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
11107086|NCT01625416|FG001|Participant Flow|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
11107087|NCT01625416|OG000|Outcome|Stepped Care Management|All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
11107088|NCT01625416|OG001|Outcome|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
11126617|NCT01734434|EG002|Reported Event|Maternal Subjects (South Africa)|Pregnant women who were enrolled in South Africa.
11126618|NCT01734434|EG003|Reported Event|Maternal Subjects (Mozambique)|Pregnant women who were enrolled in Mozambique.
11336509|NCT03567291|OG000|Outcome|TEV-50717|All participants underwent TEV-50717 dose titration in this study. They received 6 mg of TEV-50717 with food on the evening of day 1. The titration scheme and maximum dose were determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study.
11107089|NCT01625416|OG000|Outcome|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
11107090|NCT01625416|EG000|Reported Event|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
11107091|NCT01625416|EG001|Reported Event|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
11107092|NCT01625455|BG000|Baseline|Placebo Then Aprepitant|These subjects received placebo during the first week and then crossed over to aprepitant for the second week.
11107093|NCT01625455|BG001|Baseline|Aprepitant Then Placebo.|These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
11107094|NCT01625455|BG002|Baseline|Total|Total of all reporting groups
11107095|NCT01625455|FG000|Participant Flow|Placebo Then Aprepitant|These subjects received placebo during the first week and then crossed over to aprepitant for the second week.
11107096|NCT01625455|FG001|Participant Flow|Aprepitant Then Placebo.|These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
11107097|NCT01625455|OG000|Outcome|Aprepitant|"Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.~Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days."
11107098|NCT01625455|OG001|Outcome|Placebo|"Matching placebo will be given in place of aprepitant~Placebo: Placebo will be given orally for a total of 7 days."
11107099|NCT01625455|EG000|Reported Event|Placebo|
11107100|NCT01625455|EG001|Reported Event|Aprepitant|
11107101|NCT01625507|BG000|Baseline|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008"
11107102|NCT01625507|FG000|Participant Flow|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
11107103|NCT01625507|OG000|Outcome|All Participants|T2D patients comparing post- to pre-intervention
11107104|NCT01625507|OG000|Outcome|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
11107105|NCT01625507|EG000|Reported Event|All Participants|T2D diabetes patients
11107106|NCT01625689|BG000|Baseline|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
11107107|NCT01625689|BG001|Baseline|Placebo|Inactive placebo was identical to the SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
11107108|NCT01625689|BG002|Baseline|Total|Total of all reporting groups
11107109|NCT01625689|FG000|Participant Flow|Serum Institute of India, Ltd. (SIIL) LAIV|The Serum Institute of India, Ltd. (SIIL) live attenuated influenza vaccine (LAIV) (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
11107110|NCT01625689|FG001|Participant Flow|Placebo|Inactive placebo was identical to SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
11107111|NCT01625689|OG000|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
11107112|NCT01625689|OG001|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
11107113|NCT01625689|EG000|Reported Event|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
11107114|NCT01625689|EG001|Reported Event|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
11336510|NCT03567291|OG000|Outcome|Randomized TEV-50717|Participants were randomized to their current dose of TEV-50717, which was administered during the Part B Randomized Drug Withdrawal (RW) 2-week period.
11336511|NCT03567291|OG001|Outcome|Randomized Placebo|Participants were randomized to placebo, which was administered during the Part B Randomized Drug Withdrawal (RW) 2-week period only.
11107115|NCT01625845|BG000|Baseline|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
11107116|NCT01625845|BG001|Baseline|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
11107117|NCT01625845|BG002|Baseline|Total|Total of all reporting groups
11107118|NCT01625845|FG000|Participant Flow|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
11107119|NCT01625845|FG001|Participant Flow|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
11107120|NCT01625845|OG000|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
11107121|NCT01625845|OG001|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
11107122|NCT01625845|EG000|Reported Event|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
11107123|NCT01625845|EG001|Reported Event|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
11107124|NCT01625897|BG000|Baseline|MP-214 1.5-9mg|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
11107125|NCT01625897|BG001|Baseline|Risperidone 2-12mg|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
11107126|NCT01625897|BG002|Baseline|Total|Total of all reporting groups
11107127|NCT01625897|FG000|Participant Flow|MP-214 1.5-9mg|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
11107128|NCT01625897|FG001|Participant Flow|Risperidone 2-12mg|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
11107129|NCT01625897|OG000|Outcome|MP-214 1.5-9mg|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
11107130|NCT01625897|OG001|Outcome|Risperidone 2-12mg|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
11107131|NCT01625897|EG000|Reported Event|MP-214 1.5-9mg|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
11107132|NCT01625897|EG001|Reported Event|Risperidone 2-12mg|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
11107133|NCT01625910|BG000|Baseline|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.~There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
11107134|NCT01625910|BG001|Baseline|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
11107135|NCT01625910|BG002|Baseline|Total|Total of all reporting groups
11107136|NCT01625910|FG000|Participant Flow|Intervention - Behavioral Counseling|The intervention group received management patterned after the
11107137|NCT01625910|FG001|Participant Flow|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
11107138|NCT01625910|OG000|Outcome|Intervention - Behavioral Counseling|The intervention group received management patterned after the
11107139|NCT01625910|OG001|Outcome|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
11107140|NCT01625910|OG000|Outcome|Intervention Group|"The survey done at baseline and follow-up asked about daily cans of sugar-sweetened beverages.~Estimate is for Change in cans of sugar sweetened beverages per day"
11107141|NCT01625910|OG001|Outcome|Control|Change in cans of sugar sweetened beverages per day
11107142|NCT01625910|EG000|Reported Event|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.~There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
11107143|NCT01625910|EG001|Reported Event|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
11107144|NCT01625923|BG000|Baseline|Olanzapine|Olanzapine
11107145|NCT01625923|FG000|Participant Flow|Olanzapine|Subjects were enrolled to receive olanzapine open-label for 8 weeks. Subjects were initially started on olanzapine 2.5 mg by mouth daily at bedtime. Subjects returned on days 7 and 14 to determine response to medication. Medication dose was increased to 5 mg on day 7 and 10 mg on day 14, respectively, if there was incomplete symptom response, which was defined as a mean change in GCSI-DD score < 0.5 from baseline.
11107146|NCT01625923|OG000|Outcome|Olanzapine|Subjects were enrolled to receive olanzapine open-label for 8 weeks. Subjects were initially started on olanzapine 2.5 mg by mouth daily at bedtime. Subjects returned on days 7 and 14 to determine response to medication. Medication dose was increased to 5 mg on day 7 and 10 mg on day 14, respectively, if there was incomplete symptom response, which was defined as a mean change in GCSI-DD score < 0.5 from baseline.
11107147|NCT01625923|OG000|Outcome|Olanzapine|"An open-label pilot study of 20 consecutive subjects ages 18 - 70 with documented delayed gastric emptying within the past 2 years and history of nausea, vomiting, bloating, anorexia, early satiation, post-prandial fullness, and weight loss for at least 6 months without structural or organic cause will be enrolled.~Olanzapine: Subjects will initially start on olanzapine 2.5 mg per mouth daily. Subjects will return on days 7 and 14 to determine response to medication and medication dose can be increased to 5 mg and 10 mg, respectively, based on incomplete symptom response (mean change GCSI-DD < 0.5). The total dose of olanzapine will not exceed 10 mg daily during this study and subjects will continue on treatment for a total of 8 weeks."
11107148|NCT01625923|EG000|Reported Event|Olanzapine|Olanzapine
11107149|NCT01625988|BG000|Baseline|LY2951742|LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107150|NCT01625988|BG001|Baseline|Placebo|Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107151|NCT01625988|BG002|Baseline|Total|Total of all reporting groups
11107152|NCT01625988|FG000|Participant Flow|LY2951742|LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107153|NCT01625988|FG001|Participant Flow|Placebo|Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107154|NCT01625988|OG000|Outcome|LY2951742|LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107155|NCT01625988|OG001|Outcome|Placebo|Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107156|NCT01625988|OG000|Outcome|LY2951742|LY2951742 (LY): 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107157|NCT01625988|EG000|Reported Event|LY2951742 Treatment Period|LY2951742: 150 mg, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107158|NCT01625988|EG001|Reported Event|Placebo Treatment Period|Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
11107159|NCT01625988|EG002|Reported Event|LY2951742 Posttreatment Period|LY2951742: The LY2951742 posttreatment period reporting group includes participants who received 150 mg LY2951742, completed the 12-week treatment period, and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period.
11336512|NCT03567291|EG000|Reported Event|Total|All participants underwent TEV-50717 dose titration in this study. They received 6 mg of TEV-50717 with food on the evening of day 1. The titration scheme and maximum dose were determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study.
11107160|NCT01625988|EG003|Reported Event|Placebo Posttreatment Period|Placebo: The Placebo posttreatment period reporting group includes participants who received 0.9% Sodium Chloride, USP; completed the 12-week treatment period; and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period.
11107161|NCT01626092|BG000|Baseline|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
11107162|NCT01626092|FG000|Participant Flow|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
11107163|NCT01626092|OG000|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
11107164|NCT01626092|EG000|Reported Event|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
11107165|NCT01626118|BG000|Baseline|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
11107166|NCT01626118|BG001|Baseline|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
11107167|NCT01626118|BG002|Baseline|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
11107168|NCT01626118|BG003|Baseline|Placebo|Placebo Group
11107169|NCT01626118|BG004|Baseline|Total|Total of all reporting groups
11107170|NCT01626118|FG000|Participant Flow|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
11107171|NCT01626118|FG001|Participant Flow|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
11107172|NCT01626118|FG002|Participant Flow|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
11107173|NCT01626118|FG003|Participant Flow|Placebo|Placebo Group
11107174|NCT01626118|OG000|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
11107175|NCT01626118|OG001|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
11107176|NCT01626118|OG002|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
11107177|NCT01626118|OG003|Outcome|Placebo|Placebo Group
11107178|NCT01626118|EG000|Reported Event|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
11107179|NCT01626118|EG001|Reported Event|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
11107180|NCT01626118|EG002|Reported Event|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
11107181|NCT01626118|EG003|Reported Event|Placebo|Placebo Group
11107182|NCT01626352|BG000|Baseline|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6"
11107183|NCT01626352|FG000|Participant Flow|Bendamustine/Ofatumumab|"All patients will receive ofatumumab and bendamustine as an intravenous (IV) infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6"
11107184|NCT01626352|OG000|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6"
11107185|NCT01626352|OG000|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6.~Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6.~Ofatumumab: Patients will receive as an IV infusion ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6"
11107186|NCT01626352|OG000|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6 (see Figure 1).~Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length).~Ofatumumab: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length)."
11107187|NCT01626352|OG000|Outcome|Bendamustine/Ofatumumab|"All patients will receive ofatumumab and bendamustine as an intravenous (IV) infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6"
11107188|NCT01626352|EG000|Reported Event|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6 (see Figure 1).~Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length).~Ofatumumab: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length)."
11107189|NCT01626391|BG000|Baseline|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
11107190|NCT01626391|BG001|Baseline|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
11107191|NCT01626391|BG002|Baseline|Total|Total of all reporting groups
11107192|NCT01626391|FG000|Participant Flow|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
11107193|NCT01626391|FG001|Participant Flow|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
11107194|NCT01626391|OG000|Outcome|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
11107195|NCT01626391|OG001|Outcome|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
11107196|NCT01626391|EG000|Reported Event|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
11107197|NCT01626391|EG001|Reported Event|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
11107198|NCT01626456|BG000|Baseline|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
11107199|NCT01626456|BG001|Baseline|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
11107200|NCT01626456|BG002|Baseline|Total|Total of all reporting groups
11107201|NCT01626456|FG000|Participant Flow|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
11107202|NCT01626456|FG001|Participant Flow|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
11107203|NCT01626456|OG000|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
11107204|NCT01626456|OG001|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
11107205|NCT01626456|OG000|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
11107206|NCT01626456|OG001|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
11107207|NCT01626456|OG002|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
11107208|NCT01626456|OG003|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
11107209|NCT01626456|OG004|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
11107210|NCT01626456|OG000|Outcome|PBO-440 mg|Subjects who received placebo in the base study and low dose in the current study
11107211|NCT01626456|OG001|Outcome|441-441 mg|Subjects who received low dose in the base study and in the current study.
11107212|NCT01626456|OG003|Outcome|882-882 mg|Subjects who received high dose in the base study and the current study.
11107213|NCT01626456|OG004|Outcome|De Novo|Subjects who did not participate in the base study.
11107214|NCT01626456|EG000|Reported Event|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
11107215|NCT01626456|EG001|Reported Event|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
11107216|NCT01626495|BG000|Baseline|CART-19 T Cells|"The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.~CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose."
11107217|NCT01626495|FG000|Participant Flow|CART-19 T Cells|"The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.~CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose."
11107218|NCT01626495|OG000|Outcome|CART-19 T Cells|"The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.~CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose."
11107219|NCT01626495|EG000|Reported Event|CART-19 T Cells|"The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.~CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose."
11107220|NCT01626664|BG000|Baseline|KW-0761|"anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)~KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression"
11107221|NCT01626664|BG001|Baseline|Investigator's Choice|"Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP~Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression~gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression~DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression"
11107222|NCT01626664|BG002|Baseline|Total|Total of all reporting groups
11107223|NCT01626664|FG000|Participant Flow|KW-0761|"anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)~KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression"
11107224|NCT01626664|FG001|Participant Flow|Investigator's Choice|"Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP~Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression~gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression~DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression"
11107225|NCT01626664|FG002|Participant Flow|IC Original Then Crossover to KW-0761|Subjects who were randomized to the Investigator's Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
11107226|NCT01626664|OG000|Outcome|KW-0761|"anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)~KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression"
11107227|NCT01626664|OG001|Outcome|Investigator's Choice|"Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP~Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression~gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression~DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression"
11107228|NCT01626664|EG000|Reported Event|KW-0761|"anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)~KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression"
11107229|NCT01626664|EG001|Reported Event|Investigator's Choice|"Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP~Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression~gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression~DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression"
11107230|NCT01626664|EG002|Reported Event|IC Original Then Crossover to KW-0761|Subjects who were randomized to the Investigator's Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
11107231|NCT01626690|BG000|Baseline|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
11107232|NCT01626690|BG001|Baseline|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
11107233|NCT01626690|BG002|Baseline|Total|Total of all reporting groups
11107234|NCT01626690|FG000|Participant Flow|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
11107235|NCT01626690|FG001|Participant Flow|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
11107236|NCT01626690|OG000|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
11107237|NCT01626690|OG001|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
11107238|NCT01626690|OG000|Outcome|Temporal Artery Thermometer|Patient temperature at time of incision as measured by temporal artery thermometer.
11107239|NCT01626690|OG001|Outcome|SpotOn (3M) Temperature Readings.|Patient temperature at time of incision as measured by SpotOn (3M) temperature monitoring system.
11107240|NCT01626690|EG000|Reported Event|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
11107241|NCT01626690|EG001|Reported Event|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
11107242|NCT01626820|BG000|Baseline|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
11107243|NCT01626820|BG001|Baseline|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
11107244|NCT01626820|BG002|Baseline|Total|Total of all reporting groups
11107245|NCT01626820|FG000|Participant Flow|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
11107246|NCT01626820|FG001|Participant Flow|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm at Day 0
11107247|NCT01626820|OG000|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
11107248|NCT01626820|OG001|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
11107249|NCT01626820|OG001|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
11107250|NCT01626820|EG000|Reported Event|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
11107251|NCT01626820|EG001|Reported Event|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
11107252|NCT01626859|BG000|Baseline|MP-214 3mg|MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
11107253|NCT01626859|BG001|Baseline|MP-214 6mg|MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
11107254|NCT01626859|BG002|Baseline|MP-214 9mg|MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
11107255|NCT01626859|BG003|Baseline|Total|Total of all reporting groups
11107256|NCT01626859|FG000|Participant Flow|MP-214 3mg|MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
11107257|NCT01626859|FG001|Participant Flow|MP-214 6mg|MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
11107258|NCT01626859|FG002|Participant Flow|MP-214 9mg|MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
11107259|NCT01626859|OG000|Outcome|MP-214 3mg|MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
11107260|NCT01626859|OG001|Outcome|MP-214 6mg|MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
11107261|NCT01626859|OG002|Outcome|MP-214 9mg|MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
11107262|NCT01626859|EG000|Reported Event|MP-214 3mg|MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
11107263|NCT01626859|EG001|Reported Event|MP-214 6mg|MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
11107264|NCT01626859|EG002|Reported Event|MP-214 9mg|MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
10846806|NCT00280059|OG001|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
11107265|NCT01626872|BG000|Baseline|MP-214 3mg|
11107266|NCT01626872|BG001|Baseline|MP-214 6mg|
11107267|NCT01626872|BG002|Baseline|MP-214 9mg|
11107268|NCT01626872|BG003|Baseline|Total|Total of all reporting groups
11107269|NCT01626872|FG000|Participant Flow|MP-214 3mg|
11107270|NCT01626872|FG001|Participant Flow|MP-214 6mg|
11107271|NCT01626872|FG002|Participant Flow|MP-214 9mg|
11107272|NCT01626872|OG000|Outcome|MP-214 3mg|
11107273|NCT01626872|OG001|Outcome|MP-214 6mg|
11107274|NCT01626872|OG002|Outcome|MP-214 9mg|
11107275|NCT01626872|EG000|Reported Event|MP-214 3mg|
11107276|NCT01626872|EG001|Reported Event|MP-214 6mg|
11107277|NCT01626872|EG002|Reported Event|MP-214 9mg|
11107278|NCT01626885|BG000|Baseline|MP-214 1.5-9 mg|MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
11107279|NCT01626885|FG000|Participant Flow|MP-214 1.5-9 mg|MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
11107280|NCT01626885|OG000|Outcome|MP-214 1.5-9 mg|MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
11107281|NCT01626885|EG000|Reported Event|MP-214 1.5-9 mg|MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
11107282|NCT01626989|BG000|Baseline|All Study Participants|All study participants that signed consent.
11107283|NCT01626989|FG000|Participant Flow|Screening Population|All patients that signed consent are considered for the screening population.
11107284|NCT01626989|FG001|Participant Flow|BiPAP Auto SV Advanced First, Then BiPAP Auto SV 4|Participants received the Philips BiPAP Auto SV Advanced for one night, then received the BiPAP Auto SV 4 for one night.
11107285|NCT01626989|FG002|Participant Flow|BiPAP Auto SV 4 First, Then BiPAP Auto SV Advanced|Participants received the Philips BiPAP Auto SV 4 for one night, then received the BiPAP Auto SV Advanced for one night
11107286|NCT01626989|OG000|Outcome|Continous Positive Airway Pressure Titriation|Baseline Polysomnograph (PSG) to qualify for randomization.
11107287|NCT01626989|OG001|Outcome|BiPAP Auto SV Advanced|"BiPAP auto SV Advanced~BiPAP auto Advanced: Auto Servo Ventilation Device"
11107288|NCT01626989|OG002|Outcome|BiPAP Auto SV 4|"Auto Servo Ventilation Device~BiPAP auto SV4: Auto Servo Ventilation Device"
11107289|NCT01626989|OG000|Outcome|Continous Positive Airway Pressure Titriation|Baseline PSG to qualify for randomization.
11107290|NCT01626989|EG000|Reported Event|All Participants|All Study participants that were consented to the study.
11107291|NCT01626989|EG001|Reported Event|BiPAP Auto SV Advanced|All participants that received the Philips BiPAP Auto SV Advanced.
11107292|NCT01626989|EG002|Reported Event|BiPAP Auto SV 4|All participants that received the Philips BiPAP Auto SV 4.
11107293|NCT01627002|BG000|Baseline|Part A|
11107294|NCT01627002|BG001|Baseline|Part B|
11107295|NCT01627002|BG002|Baseline|Total|Total of all reporting groups
11107296|NCT01627002|FG000|Participant Flow|Part A PA401 0.1 mg|
11107297|NCT01627002|FG001|Participant Flow|Part A PA401 0.3 mg|
11107298|NCT01627002|FG002|Participant Flow|Part A PA401 1.0 mg|
11107299|NCT01627002|FG003|Participant Flow|Part A PA401 3.0 mg|
11107300|NCT01627002|FG004|Participant Flow|Part A PA401 10 mg|
11107301|NCT01627002|FG005|Participant Flow|Part A Placebo|
11107302|NCT01627002|FG006|Participant Flow|Part B PA401 1.0 mg|PA401 1.0 mg was administered 30 minutes after lipopolysaccharide challenge
11107303|NCT01627002|FG007|Participant Flow|Part B PA401 3.0 mg|PA401 3.0 mg was administered 30 minutes after lipopolysaccharide challenge
11107304|NCT01627002|FG008|Participant Flow|Part B Placebo|Placebo was administered 30 minutes after lipopolysaccharide challenge
11107305|NCT01627002|OG000|Outcome|Part A PA401 0.1 mg|
11107306|NCT01627002|OG001|Outcome|Part A PA401 0.3 mg|
11107307|NCT01627002|OG002|Outcome|Part A PA401 1.0 mg|
11107308|NCT01627002|OG003|Outcome|Part A PA401 3.0 mg|
11107309|NCT01627002|OG004|Outcome|Part A PA401 10 mg|
11107310|NCT01627002|OG005|Outcome|Part A Placebo|
11107311|NCT01627002|OG006|Outcome|Part B PA401 1.0 mg|
11107312|NCT01627002|OG007|Outcome|Part B PA401 3.0 mg|
11107313|NCT01627002|OG008|Outcome|Part B Placebo|
11107314|NCT01627002|OG000|Outcome|Part A PA401 1.0 mg|
11107315|NCT01627002|OG001|Outcome|Part A PA401 3.0 mg|
11107316|NCT01627002|OG002|Outcome|Part B PA401 1.0 mg|
11107317|NCT01627002|OG003|Outcome|Part B PA401 3.0 mg|
11107318|NCT01627002|OG000|Outcome|Part B 3.0 mg PA401|
11107319|NCT01627002|OG001|Outcome|Part B 1.0 mg PA401|
11107320|NCT01627002|OG002|Outcome|Part B Placebo|
11107321|NCT01627002|EG000|Reported Event|Part A PA401 0.1 mg|
11107322|NCT01627002|EG001|Reported Event|Part A PA401 0.3 mg|
11107323|NCT01627002|EG002|Reported Event|Part A PA401 1.0 mg|
11107324|NCT01627002|EG003|Reported Event|Part A PA401 3.0 mg|
11107325|NCT01627002|EG004|Reported Event|Part A PA401 10 mg|
11107326|NCT01627002|EG005|Reported Event|Part A Placebo|
11107327|NCT01627002|EG006|Reported Event|Part B PA401 1.0 mg|
11107328|NCT01627002|EG007|Reported Event|Part B PA401 3.0 mg|
11107329|NCT01627002|EG008|Reported Event|Part B Placebo|
11107330|NCT01627067|BG000|Baseline|Everolimus + Exemestane + Metformin|Exemestane 25 mg by mouth once a day daily for 28, Everolimus 10 mg by mouth once a day daily for 28, days and Metformin upto 1000 mg by mouth twice a day daily for 28 days cycle.
11107331|NCT01627067|FG000|Participant Flow|Everolimus + Exemestane + Metformin|Exemestane 25 mg by mouth once a day daily for 28, Everolimus 10 mg by mouth once a day daily for 28, days and Metformin upto 1000 mg by mouth twice a day daily for 28 days cycle.
11107332|NCT01627067|OG000|Outcome|Everolimus + Exemestane + Metformin|Exemestane 25 mg by mouth once a day daily for 28, Everolimus 10 mg by mouth once a day daily for 28, days and Metformin upto 1000 mg by mouth twice a day daily for 28 days cycle.
11107333|NCT01627067|OG000|Outcome|Compare PFS Between Obese and Overweight Participants|obese patient ( n=11; BMI >/=25 kg/m2) and overweight patients (n=11; BMI </=25 kg/m2)
11107334|NCT01627067|OG000|Outcome|Compare OS Between Obese Patient and Overweight Participants|obese patients( n=11; BMI >/=25 kg/m2) and overweight patients (n=11; BMI </=25 kg/m2)
11107335|NCT01627067|EG000|Reported Event|Everolimus + Exemestane + Metformin|Exemestane 25 mg by mouth once a day daily for 28, Everolimus 10 mg by mouth once a day daily for 28, days and Metformin upto 1000 mg by mouth twice a day daily for 28 days cycle.
11107336|NCT01627249|BG000|Baseline|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
11107337|NCT01627249|BG001|Baseline|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
11107338|NCT01627249|BG002|Baseline|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
11107339|NCT01627249|BG003|Baseline|Total|Total of all reporting groups
11107340|NCT01627249|FG000|Participant Flow|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
11107341|NCT01627249|FG001|Participant Flow|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
11107342|NCT01627249|FG002|Participant Flow|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
11107343|NCT01627249|OG000|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
11107344|NCT01627249|OG001|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
11107345|NCT01627249|OG002|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
11107346|NCT01627249|EG000|Reported Event|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
11107347|NCT01627249|EG001|Reported Event|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
11107348|NCT01627249|EG002|Reported Event|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
11107349|NCT01627288|BG000|Baseline|Boost Radiation: Dose Level 1|2.4 Gy X 25 fractions = 60 Gy
11107350|NCT01627288|BG001|Baseline|Boost Radiation: Dose Level 2|2.6 Gy X 25 fractions = 65 Gy
11107351|NCT01627288|BG002|Baseline|Boost Radiation: Dose Level 3|2.8 Gy x 25 fractions = 70 Gy
11107352|NCT01627288|BG003|Baseline|Boost Radiation Dose Level 0|"If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below.~Dose level 0: 2.2 Gy X 25 fractions = 55 Gy"
11107353|NCT01627288|BG004|Baseline|Total|Total of all reporting groups
11107354|NCT01627288|FG000|Participant Flow|Boost Radiation: Dose Level 1|2.4 Gy X 25 fractions = 60 Gy
11107355|NCT01627288|FG001|Participant Flow|Boost Radiation: Dose Level 2|2.6 Gy X 25 fractions = 65 Gy
11107356|NCT01627288|FG002|Participant Flow|Boost Radiation: Dose Level 3|2.8 Gy x 25 fractions = 70 Gy
11107357|NCT01627288|FG003|Participant Flow|Boost Radiation Dose Level 0|"If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below.~Dose level 0: 2.2 Gy X 25 fractions = 55 Gy"
11107358|NCT01627288|OG000|Outcome|Treatment Arm|Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).
11107359|NCT01627288|OG000|Outcome|Combined Treatment Arms|Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=3), or 2.8 Gy x 25 fractions = 70 Gy (N=6).
11107360|NCT01627288|OG001|Outcome|Boost Radiation: Dose Level 1 (60 Gy)|Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction
11107361|NCT01627288|OG002|Outcome|Boost Radiation: Dose Level 2 (65)|Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction
11107362|NCT01627288|OG003|Outcome|Boost Radiation: Dose Level 3 (70Gy)|Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction
11107363|NCT01627288|OG002|Outcome|Boost Radiation: Dose Level 2 (65)|Dose level 1 consists of a total 65Gy given in 2.6 Gy per fraction
11107364|NCT01627288|OG003|Outcome|Boost Radiation: Dose Level 3 (70Gy)|Dose level 1 consists of a total 70Gy given in 2.8 Gy per fraction
11107365|NCT01627288|EG000|Reported Event|Dose Level 1|Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3)
11107366|NCT01627288|EG001|Reported Event|Dose Level 2|2.6 Gy X 25 fractions = 65 Gy (N=3),
11107367|NCT01627288|EG002|Reported Event|Dose Level 3|2.8 Gy x 25 fractions = 70 Gy (N=6)
11107368|NCT01627327|BG000|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
11107369|NCT01627327|BG001|Baseline|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
11107370|NCT01627327|BG002|Baseline|Total|Total of all reporting groups
11107371|NCT01627327|FG000|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) inhalation once daily (OD) via a dry powder inhaler (DPI) and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
11107372|NCT01627327|FG001|Participant Flow|TIO 18 µg OD|Participants received tiotropium bromide (TIO) 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
11107373|NCT01627327|OG000|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
11107374|NCT01627327|OG001|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
11107375|NCT01627327|EG000|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
11107376|NCT01627327|EG001|Reported Event|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
10846807|NCT00280059|OG000|Outcome|Pregabalin 150 mg/Day|Pregabalin 150 mg/day administered twice daily (BID)
10846808|NCT00280059|OG001|Outcome|Pregabalin 300 mg/Day|Pregabalin 300 mg/day administered BID
11107377|NCT01627340|BG000|Baseline|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
11107378|NCT01627340|BG001|Baseline|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
11107379|NCT01627340|BG002|Baseline|Total|Total of all reporting groups
11107380|NCT01627340|FG000|Participant Flow|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
11107381|NCT01627340|FG001|Participant Flow|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
11107382|NCT01627340|OG000|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
11107383|NCT01627340|OG001|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
11107384|NCT01627340|OG000|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of EngerixTM-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
11107385|NCT01627340|OG001|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of EngerixTM-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
11107386|NCT01627340|EG000|Reported Event|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
11107387|NCT01627340|EG001|Reported Event|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
11107388|NCT01627691|BG000|Baseline|REPRISE II and Extension Overall|"Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.~Lotus Valve System: - bioprosthetic bovine pericardial aortic valve~- delivery system"
11107389|NCT01627691|FG000|Participant Flow|REPRISE II and Extension Overall|"Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.~Lotus Valve System: - bioprosthetic bovine pericardial aortic valve~- delivery system"
11107390|NCT01627691|OG000|Outcome|REPRISE II and Extension Overall|"Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.~Lotus Valve System: - bioprosthetic bovine pericardial aortic valve~- delivery system"
11107391|NCT01627691|EG000|Reported Event|REPRISE II and Extension Overall|"Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.~Lotus Valve System: - bioprosthetic bovine pericardial aortic valve~- delivery system"
11107392|NCT01627782|BG000|Baseline|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
11107393|NCT01627782|BG001|Baseline|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
11107394|NCT01627782|BG002|Baseline|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
11107395|NCT01627782|BG003|Baseline|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
11107396|NCT01627782|BG004|Baseline|Total|Total of all reporting groups
11107397|NCT01627782|FG000|Participant Flow|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
11107398|NCT01627782|FG001|Participant Flow|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
11107399|NCT01627782|FG002|Participant Flow|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
11107400|NCT01627782|FG003|Participant Flow|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
11107401|NCT01627782|OG000|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
11107402|NCT01627782|OG001|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
11107403|NCT01627782|OG002|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
11107404|NCT01627782|OG003|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
11107405|NCT01627782|OG000|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
11107406|NCT01627782|OG001|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
11107407|NCT01627782|EG000|Reported Event|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
11107408|NCT01627782|EG001|Reported Event|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
11107409|NCT01627782|EG002|Reported Event|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
11107410|NCT01627782|EG003|Reported Event|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
11107411|NCT01627860|BG000|Baseline|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
10846809|NCT00280059|OG002|Outcome|Pregabalin 450 mg/Day|Pregabalin 450 mg/day administered BID
11107412|NCT01627860|BG001|Baseline|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
11107413|NCT01627860|BG002|Baseline|Total|Total of all reporting groups
11107414|NCT01627860|FG000|Participant Flow|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
11107415|NCT01627860|FG001|Participant Flow|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
11107416|NCT01627860|OG000|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
11107417|NCT01627860|OG001|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
11107418|NCT01627860|EG000|Reported Event|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
11107419|NCT01627860|EG001|Reported Event|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
11107420|NCT01628016|BG000|Baseline|Attentional Bias Modification Training|Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. The task was a modified dot-probe task, in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. Each session consists of 218 trials, and the time to complete a training session is 12 minutes (4 sessions a week, roughly one session every other day with for each session).
11107421|NCT01628016|BG001|Baseline|Placebo Training|.Participants complete 8 sessions of placebo training(PT) during a two-week period.The placebo training procedure is a classic dot probe task in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.Each session consists of 218 trials, and the time to complete a PT session is approximately 12 minutes as well.The stimuli is identical to ABM condition.
11107422|NCT01628016|BG002|Baseline|Assessment-only Control|Participants only complete assessment at each point time.
11107423|NCT01628016|BG003|Baseline|Total|Total of all reporting groups
11107424|NCT01628016|FG000|Participant Flow|Attentional Bias Modification Training|"Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes (4 sessions a week, roughly one session every other day with for each session).~a word dot-probe task for training procedure: In the word dot-probe task for training procedure of attention bias modification, 90% of the targets appeared at the neutral word position and 10% at the sad word position.In the placebo condition, the targets appeared with equal probability"
11107425|NCT01628016|FG001|Participant Flow|Placebo Training|"Participants complete 8 sessions of placebo training(PT) during a two-week period. Placebo training is a classic dot probe task, in which a probe appears after either of the locations that the two stimuli (i.e. one is the depressive cue and the other is neutral) were presented, with the same frequencies. In the PT condition, each session also consists of 218 trials, and the time to complete a PT session is approximately 10 minutes as well.~a word dot-probe task for training procedure: In the word dot-probe task for training procedure of attention bias modification, 90% of the targets appeared at the neutral word position and 10% at the sad word position.In the placebo condition, the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.All participants in ABM and placebo conditions received eight 12-min training sessions over a 2-week period.During each session, participants completed 216 word dot-probe trials."
11107426|NCT01628016|FG002|Participant Flow|Blank Control|Participants only complete assessment at each point time.
11107427|NCT01628016|OG000|Outcome|Attentional Bias Modification Training|The training procedure of attention bias modification is a modified dot-probe task,in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes (4 sessions a week, roughly one session every other day with for each session).
11107428|NCT01628016|OG001|Outcome|Placebo Training|Placebo training procedure is a classic dot probe task, in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.Participants complete 8 sessions of placebo training(PT) during a two-week period and each session consists of 218 trials.The stimuli was identical to the ABM condition.
11107429|NCT01628016|OG002|Outcome|Blank Control|Participants only complete assessment at each point time.
11107430|NCT01628016|OG000|Outcome|Attentional Bias Modification Training|Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes (4 sessions a week, roughly one session every other day with for each session).
11107431|NCT01628016|OG001|Outcome|Placebo Training|Participants complete 8 sessions of placebo training(PT) during a two-week period.
11107432|NCT01628016|EG000|Reported Event|Attentional Bias Modification Training|Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes (4 sessions a week, roughly one session every other day with for each session).
11107433|NCT01628016|EG001|Reported Event|Placebo Training|Participants complete 8 sessions of placebo training(PT) during a two-week period. Placebo training is a classic dot probe task, in which a probe appears after either of the locations that the two stimuli (i.e. one is the depressive cue and the other is neutral) were presented, with the same frequencies. In the PT condition, each session also consists of 218 trials, and the time to complete a PT session is approximately 10 minutes as well.
11107434|NCT01628016|EG002|Reported Event|Blank Control|Participants only complete assessment at each point time.
11107435|NCT01628042|BG000|Baseline|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107436|NCT01628042|BG001|Baseline|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107437|NCT01628042|BG002|Baseline|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107438|NCT01628042|BG003|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107439|NCT01628042|BG004|Baseline|Total|Total of all reporting groups
11107440|NCT01628042|FG000|Participant Flow|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107441|NCT01628042|FG001|Participant Flow|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107442|NCT01628042|FG002|Participant Flow|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107443|NCT01628042|FG003|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107444|NCT01628042|OG000|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107445|NCT01628042|OG001|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107446|NCT01628042|OG002|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
10846810|NCT00280059|OG003|Outcome|Pregabalin 600 mg/Day|Pregabalin 600 mg/day administered BID
11107447|NCT01628042|OG003|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107448|NCT01628042|EG000|Reported Event|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107449|NCT01628042|EG001|Reported Event|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107450|NCT01628042|EG002|Reported Event|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
10846811|NCT00280059|OG004|Outcome|Lamotrigine 100 mg/Day|Lamotrigine 100 mg/day administered BID
10846812|NCT00280059|OG005|Outcome|Lamotrigine 200 mg/Day|Lamotrigine 200 mg/day administered BID
11107451|NCT01628042|EG003|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
11107452|NCT01628107|BG000|Baseline|Epoetin Hospira|Participants were enrolled to receive Epoetin Hospira intravenous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
11107453|NCT01628107|FG000|Participant Flow|Epoetin Hospira|Participants were enrolled to receive Epoetin Hospira intravenous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
11107454|NCT01628107|OG000|Outcome|Epoetin Hospira|Participants were enrolled to receive Epoetin Hospira intravenous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
11107455|NCT01628107|EG000|Reported Event|Epoetin Hospira|Participants were enrolled to receive Epoetin Hospira intravenous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
11107456|NCT01628120|BG000|Baseline|Epoetin Hospira|Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
11107457|NCT01628120|FG000|Participant Flow|Epoetin Hospira|Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
11107458|NCT01628120|OG000|Outcome|Epoetin Hospira|Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
11107459|NCT01628120|EG000|Reported Event|Epoetin Hospira|Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
11107460|NCT01628159|BG000|Baseline|Lutonix Drug Coated Balloon|"Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter~Lutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon"
11107461|NCT01628159|FG000|Participant Flow|Lutonix Drug Coated Balloon|"Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter~Lutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon"
11107462|NCT01628159|OG000|Outcome|Lutonix Drug Coated Balloon|"Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter~Lutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon"
11107463|NCT01628159|EG000|Reported Event|Lutonix Drug Coated Balloon|"Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter~Lutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon"
11107464|NCT01628198|BG000|Baseline|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
11107465|NCT01628198|FG000|Participant Flow|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
11107466|NCT01628198|OG000|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
11107467|NCT01628198|EG000|Reported Event|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
11107468|NCT01628250|BG000|Baseline|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
11107469|NCT01628250|BG001|Baseline|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
11107470|NCT01628250|BG002|Baseline|Total|Total of all reporting groups
11107471|NCT01628250|FG000|Participant Flow|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
11107472|NCT01628250|FG001|Participant Flow|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
11107473|NCT01628250|OG000|Outcome|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
11107474|NCT01628250|OG001|Outcome|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
11107475|NCT01628250|EG000|Reported Event|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
11107476|NCT01628250|EG001|Reported Event|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
11107477|NCT01628367|BG000|Baseline|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
11107478|NCT01628367|BG001|Baseline|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
11107479|NCT01628367|BG002|Baseline|Total|Total of all reporting groups
11107480|NCT01628367|FG000|Participant Flow|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
11107481|NCT01628367|FG001|Participant Flow|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
10846813|NCT00280059|OG006|Outcome|Lamotrigine 400 mg/Day|Lamotrigine 400 mg/day administered BID
11107482|NCT01628367|OG000|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
11107483|NCT01628367|OG001|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
11107484|NCT01628367|EG000|Reported Event|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
11107485|NCT01628367|EG001|Reported Event|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
11107486|NCT01628393|BG000|Baseline|Placebo|Participants received placebo capsules by mouth (PO) daily during the 24-week placebo-controlled treatment period.
11107487|NCT01628393|BG001|Baseline|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.
11107488|NCT01628393|BG002|Baseline|Ozanimod 1 mg|Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.
11107489|NCT01628393|BG003|Baseline|Total|Total of all reporting groups
11107490|NCT01628393|FG000|Participant Flow|Placebo|Participants received placebo capsules by mouth (PO) daily during the 24-week placebo-controlled treatment period.
11107491|NCT01628393|FG001|Participant Flow|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension phase and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks of treatment.
11107492|NCT01628393|FG002|Participant Flow|Ozanimod 1 mg|Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension phase and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks of treatment.
11107493|NCT01628393|FG003|Participant Flow|Placebo / Ozanimod 0.5 mg|Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg PO daily during the blinded extension period for 96 weeks.
11107494|NCT01628393|FG004|Participant Flow|Placebo / Ozanimod 1 mg|Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg PO daily during the blinded extension period for 96 weeks.
11107495|NCT01628393|OG000|Outcome|Placebo|Participants received placebo capsules PO daily during the 24-week placebo-controlled period.
11107496|NCT01628393|OG001|Outcome|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.
11107497|NCT01628393|OG002|Outcome|Ozanimod 1 mg|Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.
11107498|NCT01628393|OG000|Outcome|Placebo / Ozanimod 0.5 mg|Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.
11107499|NCT01628393|OG001|Outcome|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.
11107500|NCT01628393|OG002|Outcome|Placebo / Ozanimod 1 mg|Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.
11107501|NCT01628393|OG003|Outcome|Ozanimod 1 mg|Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
11107502|NCT01628393|EG000|Reported Event|Placebo-Controlled Period: Placebo|Participants received placebo capsules PO daily during the 24-week placebo-controlled period.
11107503|NCT01628393|EG001|Reported Event|Placebo-Controlled Period: Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled period.
11107504|NCT01628393|EG002|Reported Event|Placebo-Controlled Period: Ozanimod 1.0 mg|Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled period.
11107505|NCT01628393|EG003|Reported Event|Extension Period: Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg capsules PO daily during the blinded extension period (Weeks 25 to 120).
10846814|NCT00280059|OG007|Outcome|Lamotrigine 500 mg/Day|Lamotrigine 500 mg/day administered BID
11107506|NCT01628393|EG004|Reported Event|Extension Period: Ozanimod 1.0 mg|Participants received ozanimod 1 mg capsules PO daily during the blinded extension period (Weeks 25 to 120).
11107507|NCT01628510|BG000|Baseline|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
11107508|NCT01628510|BG001|Baseline|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
11107509|NCT01628510|BG002|Baseline|Total|Total of all reporting groups
11107510|NCT01628510|FG000|Participant Flow|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
11107511|NCT01628510|FG001|Participant Flow|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
11107512|NCT01628510|OG000|Outcome|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
11107513|NCT01628510|OG001|Outcome|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
11107514|NCT01628510|OG000|Outcome|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional NICU Positioning: These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper®"
11107515|NCT01628510|OG001|Outcome|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when the infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
11107516|NCT01628510|EG000|Reported Event|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
11107517|NCT01628510|EG001|Reported Event|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
11107518|NCT01628523|BG000|Baseline|Entire Cohort|Characteristics of mechanically ventilated ED patients
11107519|NCT01628523|FG000|Participant Flow|All ED Patients Requiring Mechanical Ventilation|Assessed for mechanical ventilation parameters, predictors of ARDS in the patients without ARDS in the ED (n=204), and outcome differences between all patients with ARDS (n=45) and those not progressing to ARDS (n= 174). These 45 patients includes the 15 patients with ARDS in the ED and the 30 participants with incident ARDS after ED admission.
11107520|NCT01628523|OG000|Outcome|Entire Cohort|Characteristics of mechanically ventilated ED patients
11107521|NCT01628523|OG000|Outcome|ARDS After Admission|Among the patients without ARDS while in the ED, these patients were analyzed for ARDS incidence after admission
11107522|NCT01628523|EG000|Reported Event|All ED Patients Requiring Mechanical Ventilation|For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube.: Mechanical ventilation via an endotracheal tube or tracheostomy tube
11107523|NCT01628549|BG000|Baseline|Placebo|Two placebo capsules matching P005672-HCl, taken orally each day
11107524|NCT01628549|BG001|Baseline|P005672-HCl Approximately 0.75 mg/kg/Day|One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
11107525|NCT01628549|BG002|Baseline|P005672-HCl Approximately 1.5 mg/kg/Day|Two P005672-HCl 50 mg capsules, taken orally each day
11107526|NCT01628549|BG003|Baseline|P005672-HCl Approximately 3.0 mg/kg/Day|Two P005672-HCl 100 mg capsules, taken orally each day
11107527|NCT01628549|BG004|Baseline|Total|Total of all reporting groups
11107528|NCT01628549|FG000|Participant Flow|Placebo|Two placebo capsules matching P005672-HCl, taken orally each day
11107529|NCT01628549|FG001|Participant Flow|P005672-HCl Approximately 0.75 mg/kg/Day|One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
11107530|NCT01628549|FG002|Participant Flow|P005672-HCl Approximately 1.5 mg/kg/Day|Two P005672-HCl 50 mg capsules, taken orally each day
11107531|NCT01628549|FG003|Participant Flow|P005672-HCl Approximately 3.0 mg/kg/Day|Two P005672-HCl 100 mg capsules, taken orally each day
11107532|NCT01628549|OG000|Outcome|Placebo|Two placebo capsules matching P005672-HCl, taken orally each day
11107533|NCT01628549|OG001|Outcome|P005672-HCl Approximately 0.75 mg/kg/Day|One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
11107534|NCT01628549|OG002|Outcome|P005672-HCl Approximately 1.5 mg/kg/Day|Two P005672-HCl 50 mg capsules, taken orally each day
11107535|NCT01628549|OG003|Outcome|P005672-HCl Approximately 3.0 mg/kg/Day|Two P005672-HCl 100 mg capsules, taken orally each day
11107536|NCT01628549|EG000|Reported Event|Placebo|Two placebo capsules matching P005672-HCl, taken orally each day
11107537|NCT01628549|EG001|Reported Event|P005672-HCl Approximately 0.75 mg/kg/Day|One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
11107538|NCT01628549|EG002|Reported Event|P005672-HCl Approximately 1.5 mg/kg/Day|Two P005672-HCl 50 mg capsules, taken orally each day
11107539|NCT01628549|EG003|Reported Event|P005672-HCl Approximately 3.0 mg/kg/Day|Two P005672-HCl 100 mg capsules, taken orally each day
11107540|NCT01628588|BG000|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
11107541|NCT01628588|FG000|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
11107542|NCT01628588|OG000|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
11107543|NCT01628588|EG000|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
11107544|NCT01628601|BG000|Baseline|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
11107545|NCT01628601|FG000|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
11107546|NCT01628601|OG000|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
11107547|NCT01628601|EG000|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
11107548|NCT01628614|BG000|Baseline|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
11107549|NCT01628614|FG000|Participant Flow|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
11107550|NCT01628614|OG000|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
11107551|NCT01628614|EG000|Reported Event|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
11107552|NCT01628692|BG000|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
11107553|NCT01628692|BG001|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107554|NCT01628692|BG002|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107555|NCT01628692|BG003|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
11107556|NCT01628692|BG004|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
11107557|NCT01628692|BG005|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
11107558|NCT01628692|BG006|Baseline|Total|Total of all reporting groups
11107559|NCT01628692|FG000|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
11107560|NCT01628692|FG001|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107561|NCT01628692|FG002|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107562|NCT01628692|FG003|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
11107563|NCT01628692|FG004|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
11107564|NCT01628692|FG005|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
11107565|NCT01628692|OG000|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
11107566|NCT01628692|OG001|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107567|NCT01628692|OG002|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107568|NCT01628692|OG003|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
11107569|NCT01628692|OG004|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
11107570|NCT01628692|OG005|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
11107571|NCT01628692|OG003|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107572|NCT01628692|OG005|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
11107573|NCT01628692|OG001|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up
11107574|NCT01628692|OG000|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
11107575|NCT01628692|OG001|Outcome|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107576|NCT01628692|OG002|Outcome|Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
11107577|NCT01628692|EG000|Reported Event|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
11107578|NCT01628692|EG001|Reported Event|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
11107579|NCT01628692|EG002|Reported Event|Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
11107580|NCT01628718|BG000|Baseline|CPT-C|"Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions.~Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of non-recovery in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these stuck points and progress toward recovery."
11107581|NCT01628718|BG001|Baseline|Adaptive Disclosure (AD)|"Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions.~Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction."
11107582|NCT01628718|BG002|Baseline|Total|Total of all reporting groups
11107583|NCT01628718|FG000|Participant Flow|CPT-C|"Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions.~Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of non-recovery in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these stuck points and progress toward recovery."
11107584|NCT01628718|FG001|Participant Flow|Adaptive Disclosure (AD)|"Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions.~Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction."
11107585|NCT01628718|OG000|Outcome|CPT-C|"Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions.~Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of non-recovery in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these stuck points and progress toward recovery."
11107586|NCT01628718|OG001|Outcome|Adaptive Disclosure (AD)|"Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions.~Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction."
11107587|NCT01628718|EG000|Reported Event|CPT-C|"Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions.~Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of non-recovery in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these stuck points and progress toward recovery."
11107588|NCT01628718|EG001|Reported Event|Adaptive Disclosure (AD)|"Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions.~Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction."
11107589|NCT01628848|BG000|Baseline|SPM 962|SPM 962 transdermal patch
11107590|NCT01628848|BG001|Baseline|Placebo|Placebo transdermal patch
11107591|NCT01628848|BG002|Baseline|Total|Total of all reporting groups
11107592|NCT01628848|FG000|Participant Flow|SPM 962|SPM 962 transdermal patch
11107593|NCT01628848|FG001|Participant Flow|Placebo|Placebo transdermal patch
11107594|NCT01628848|OG000|Outcome|SPM 962|SPM 962 transdermal patch
11107595|NCT01628848|OG001|Outcome|Placebo|Placebo transdermal patch
11107596|NCT01628848|EG000|Reported Event|SPM 962|SPM 962 transdermal patch
11107597|NCT01628848|EG001|Reported Event|Placebo|Placebo transdermal patch
10846815|NCT00280059|EG000|Reported Event|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
11107598|NCT01628874|BG000|Baseline|EMLA Cream, Then Placebo Via J-Tip|Patients in this arm received 1g EMLA cream (lidocaine 2.5% and prilocaine 2.5%) placed on the lumbar puncture site for a minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL NS placebo injection via the J-Tip at the lumbar puncture site.
11107599|NCT01628874|BG001|Baseline|Placebo Cream, Then Lidocaine Via J-Tip|Participants in this arm had placebo cream placed on the lumbar puncture site for minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL (5mg) of 1% lidocaine injection via the J-Tip at the lumbar puncture site.
11107600|NCT01628874|BG002|Baseline|Total|Total of all reporting groups
11107601|NCT01628874|FG000|Participant Flow|EMLA Cream, Then Placebo Via J-Tip|Patients in this arm received 1g EMLA cream (lidocaine 2.5% and prilocaine 2.5%) placed on the lumbar puncture site for a minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL NS placebo injection via the J-Tip at the lumbar puncture site.
11107602|NCT01628874|FG001|Participant Flow|Placebo Cream, Then Lidocaine Via J-Tip|Participants in this arm had placebo cream placed on the lumbar puncture site for minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL (5mg) of 1% lidocaine injection via the J-Tip at the lumbar puncture site.
11107603|NCT01628874|OG000|Outcome|EMLA Cream, Then Placebo Via J-Tip|Patients in this arm received 1g EMLA cream (lidocaine 2.5% and prilocaine 2.5%) placed on the lumbar puncture site for a minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL NS placebo injection via the J-Tip at the lumbar puncture site.
11107604|NCT01628874|OG001|Outcome|Placebo Cream, Then Lidocaine Via J-Tip|Participants in this arm had placebo cream placed on the lumbar puncture site for minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL (5mg) of 1% lidocaine injection via the J-Tip at the lumbar puncture site.
11107605|NCT01628874|EG000|Reported Event|EMLA Cream, Then Placebo Via J-Tip|Patients in this arm received 1g EMLA cream (lidocaine 2.5% and prilocaine 2.5%) placed on the lumbar puncture site for a minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL NS placebo injection via the J-Tip at the lumbar puncture site.
11107606|NCT01628874|EG001|Reported Event|Placebo Cream, Then Lidocaine Via J-Tip|Participants in this arm had placebo cream placed on the lumbar puncture site for minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL (5mg) of 1% lidocaine injection via the J-Tip at the lumbar puncture site.
11107607|NCT01628913|BG000|Baseline|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
11107608|NCT01628913|BG001|Baseline|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
11107609|NCT01628913|BG002|Baseline|Total|Total of all reporting groups
11107610|NCT01628913|FG000|Participant Flow|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
11107611|NCT01628913|FG001|Participant Flow|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
11107612|NCT01628913|OG000|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
11107613|NCT01628913|OG001|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
11107614|NCT01628913|EG000|Reported Event|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
11107615|NCT01628913|EG001|Reported Event|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
11107616|NCT01628926|BG000|Baseline|SPM 962|SPM 962 transdermal patch
11107617|NCT01628926|BG001|Baseline|Ropinirole|Ropinirole tablet
11107618|NCT01628926|BG002|Baseline|Placebo|SPM962 placebo patch and Ropinirole placebo tab
11107619|NCT01628926|BG003|Baseline|Total|Total of all reporting groups
11107620|NCT01628926|FG000|Participant Flow|SPM 962|SPM 962 transdermal patch
11107621|NCT01628926|FG001|Participant Flow|Ropinirole|Ropinirole tablet
11107622|NCT01628926|FG002|Participant Flow|Placebo|SPM962 placebo patch and Ropinirole placebo tab
11107623|NCT01628926|OG000|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
11107624|NCT01628926|OG001|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
11107625|NCT01628926|OG002|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
11107626|NCT01628926|OG002|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
11107627|NCT01628926|EG000|Reported Event|SPM 962|SPM 962 transdermal patch
11107628|NCT01628926|EG001|Reported Event|Ropinirole|Ropinirole tablet
11107629|NCT01628926|EG002|Reported Event|Placebo|SPM962 placebo patch and Ropinirole placebo tab
11107630|NCT01628965|BG000|Baseline|SPM 962|SPM 962 transdermal patch
11107631|NCT01628965|FG000|Participant Flow|SPM 962|SPM 962 transdermal patch
11107632|NCT01628965|OG000|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
11107633|NCT01628965|EG000|Reported Event|SPM 962|SPM 962 transdermal patch
11107634|NCT01629134|BG000|Baseline|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
11107635|NCT01629134|FG000|Participant Flow|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
11107636|NCT01629134|OG000|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
11107637|NCT01629134|EG000|Reported Event|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
11107638|NCT01629290|BG000|Baseline|Varnish and Placebo|Three dental varnishes with 5% NaF active ingredient and placebo bland varnish containing no NaF
11107639|NCT01629290|FG000|Participant Flow|Varnishes and Placebo|"Three dental varnishes with 5% NaF active ingredient (Enamel Pro, Duraphat and Vanish) and one bland varnish with no NaF applied to each subject at four timepoints.~Each of the 15 participants received each of the four treatments, but the order followed was randomly arranged to be different, so there were twelve different patterns of assignment. Because all participants completed all four interventions, and the order was different for each, milestones are not used to indicate participation in each treatment, as that might imply a sequence, rather than simply that they received that intervention."
11107640|NCT01629290|OG000|Outcome|Enamel Pro|Dental varnish with 5% NaF active ingredient
11107641|NCT01629290|OG001|Outcome|Duraphat|Dental varnish with 5% NaF active ingredient
11107642|NCT01629290|OG002|Outcome|Vanish|Dental varnish with 5% NaF active ingredient
11107643|NCT01629290|OG003|Outcome|Placebo|Bland varnish containing no NaF
11107644|NCT01629290|EG000|Reported Event|Enamel Pro|Dental varnish with 5% NaF active ingredient
11107645|NCT01629290|EG001|Reported Event|Placebo|Placebo bland varnish containing no NaF
11107646|NCT01629290|EG002|Reported Event|Duraphat|Dental varnish with 5% NaF active ingredient
11107647|NCT01629290|EG003|Reported Event|Vanish|Dental varnish with 5% NaF active ingredient
11107648|NCT01629381|BG000|Baseline|Rivaroxaban|"Oral Rivaroxaban 10 mg od for 7 days~Rivaroxaban: 10 mg os once daily for 1 week"
11107649|NCT01629381|BG001|Baseline|Placebo|"oral placebo od for 7 days~placebo: 10 mg os once daily for 1 week"
11107650|NCT01629381|BG002|Baseline|Total|Total of all reporting groups
11107651|NCT01629381|FG000|Participant Flow|Rivaroxaban|"Oral Rivaroxaban 10 mg od for 7 days~Rivaroxaban: 10 mg os once daily for 1 week"
11107652|NCT01629381|FG001|Participant Flow|Placebo|"oral placebo od for 7 days~placebo: 10 mg os once daily for 1 week"
11107653|NCT01629381|OG000|Outcome|Rivaroxaban|"Oral Rivaroxaban 10 mg od for 7 days~Rivaroxaban: 10 mg os once daily for 1 week"
11107654|NCT01629381|OG001|Outcome|Placebo|"oral placebo od for 7 days~placebo: 10 mg os once daily for 1 week"
11107655|NCT01629381|OG000|Outcome|Placebo|No major bleeding events were observed during the study period.
11107656|NCT01629381|OG001|Outcome|Rivaroxaban 10 mg for 7 Days|No major bleeding events were observed during the study period.
11107657|NCT01629381|OG000|Outcome|Placebo|oral placebo od for 7 days placebo: 10 mg os once daily for 1 week
11107658|NCT01629381|OG001|Outcome|Rivaroxaban 10 mg for 7 Days|Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week
11107659|NCT01629381|EG000|Reported Event|Placebo|oral placebo od for 7 days placebo: 10 mg os once daily for 1 week
11107660|NCT01629381|EG001|Reported Event|Rivaroxaban 10 mg for 7 Days|Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week
11107661|NCT01629563|BG000|Baseline|Ulipristal Acetate (PGL4001) 5mg|PGL4001 5 mg: PGL4001 5 mg daily administration
11107662|NCT01629563|BG001|Baseline|Ulipristal Acetate (PGL4001) 10mg|PGL4001 10 mg: PGL4001 10mg daily administration
11107663|NCT01629563|BG002|Baseline|Total|Total of all reporting groups
11107664|NCT01629563|FG000|Participant Flow|Ulipristal Acetate (PGL4001) 5mg|PGL4001 5 mg: PGL4001 5 mg daily administration
11107665|NCT01629563|FG001|Participant Flow|Ulipristal Acetate (PGL4001) 10mg|PGL4001 10 mg: PGL4001 10mg daily administration
11107666|NCT01629563|OG000|Outcome|Ulipristal Acetate (PGL4001) 5mg|PGL4001 5 mg: PGL4001 5 mg daily administration
11107667|NCT01629563|OG001|Outcome|Ulipristal Acetate (PGL4001) 10mg|PGL4001 10 mg: PGL4001 10mg daily administration
11107668|NCT01629563|EG000|Reported Event|Ulipristal Acetate (PGL4001) 5mg|PGL4001 5 mg: PGL4001 5 mg daily administration
11107669|NCT01629563|EG001|Reported Event|Ulipristal Acetate (PGL4001) 10mg|PGL4001 10 mg: PGL4001 10mg daily administration
11107670|NCT01629589|BG000|Baseline|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
11107671|NCT01629589|BG001|Baseline|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
11107672|NCT01629589|BG002|Baseline|Total|Total of all reporting groups
11107673|NCT01629589|FG000|Participant Flow|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
11107674|NCT01629589|FG001|Participant Flow|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
11107675|NCT01629589|OG000|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
11107676|NCT01629589|OG001|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
11107677|NCT01629589|EG000|Reported Event|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
11107678|NCT01629589|EG001|Reported Event|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
11107679|NCT01629615|BG000|Baseline|BKM120|BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
11107680|NCT01629615|FG000|Participant Flow|BKM120|BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
11107681|NCT01629615|OG000|Outcome|BKM120|BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
11107682|NCT01629615|EG000|Reported Event|BKM120|BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
11107683|NCT01629667|BG000|Baseline|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
11107684|NCT01629667|BG001|Baseline|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
11107685|NCT01629667|BG002|Baseline|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
11107686|NCT01629667|BG003|Baseline|Total|Total of all reporting groups
11107687|NCT01629667|FG000|Participant Flow|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
11107688|NCT01629667|FG001|Participant Flow|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
11107689|NCT01629667|FG002|Participant Flow|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
11107690|NCT01629667|OG000|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
11107691|NCT01629667|OG001|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
11107692|NCT01629667|OG002|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
11107693|NCT01629667|OG000|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
11107694|NCT01629667|OG001|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
11107695|NCT01629667|EG000|Reported Event|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
11107696|NCT01629667|EG001|Reported Event|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
11107697|NCT01629667|EG002|Reported Event|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
11107698|NCT01629693|BG000|Baseline|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
11107699|NCT01629693|BG001|Baseline|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
11107700|NCT01629693|BG002|Baseline|Total|Total of all reporting groups
11107701|NCT01629693|FG000|Participant Flow|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
11107702|NCT01629693|FG001|Participant Flow|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
11107703|NCT01629693|OG000|Outcome|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
11107704|NCT01629693|OG001|Outcome|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
11107705|NCT01629693|EG000|Reported Event|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
11107706|NCT01629693|EG001|Reported Event|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
11107707|NCT01629706|BG000|Baseline|Overall|All enrolled participants
11107708|NCT01629706|FG000|Participant Flow|PureVision/Habitual|Phase 1: Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for two hours and four hours at a time, separate days, with Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in the fellow eye. Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care.
11107709|NCT01629706|OG000|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
11107710|NCT01629706|OG001|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
11107711|NCT01629706|OG000|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
11107712|NCT01629706|OG001|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
11107713|NCT01629706|EG000|Reported Event|PureVision|Balafilcon A contact lenses worn in Phase 1
11107714|NCT01629706|EG001|Reported Event|Habitual|Habitual contact lenses worn in Phase 2
11107715|NCT01629771|BG000|Baseline|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
11107716|NCT01629771|BG001|Baseline|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
11107717|NCT01629771|BG002|Baseline|Total|Total of all reporting groups
11107718|NCT01629771|FG000|Participant Flow|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
11107719|NCT01629771|FG001|Participant Flow|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
11107720|NCT01629771|OG000|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
11107721|NCT01629771|OG001|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
11107722|NCT01629771|EG000|Reported Event|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
11107723|NCT01629771|EG001|Reported Event|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
11107724|NCT01629784|BG000|Baseline|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
11107725|NCT01629784|FG000|Participant Flow|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
11107726|NCT01629784|OG000|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
11107727|NCT01629784|OG001|Outcome|Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
11107728|NCT01629784|OG000|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
11107729|NCT01629784|OG001|Outcome|Three Months Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
11107730|NCT01629784|EG000|Reported Event|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
11107731|NCT01629797|BG000|Baseline|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
11107732|NCT01629797|FG000|Participant Flow|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
11107733|NCT01629797|OG000|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
11107734|NCT01629797|OG001|Outcome|Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
11107735|NCT01629797|OG000|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
11107736|NCT01629797|OG001|Outcome|Two Months Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
11107737|NCT01629797|EG000|Reported Event|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
11107738|NCT01629823|BG000|Baseline|CPAP Less Than 1 cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107739|NCT01629823|BG001|Baseline|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107740|NCT01629823|BG002|Baseline|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107741|NCT01629823|BG003|Baseline|Total|Total of all reporting groups
11107742|NCT01629823|FG000|Participant Flow|CPAP Less Than 1 cm Water (H₂O)|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
11107743|NCT01629823|FG001|Participant Flow|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
11107744|NCT01629823|FG002|Participant Flow|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
11107745|NCT01629823|OG000|Outcome|CPAP Less Than 1 cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107746|NCT01629823|OG001|Outcome|CPAP 5cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107747|NCT01629823|OG002|Outcome|CPAP 10cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107748|NCT01629823|EG000|Reported Event|CPAP Less Than 1 cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107749|NCT01629823|EG001|Reported Event|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107750|NCT01629823|EG002|Reported Event|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
11107751|NCT01629862|BG000|Baseline|Active CPAP|"Therapeutic continuous positive airway pressure (CPAP).~Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia)."
11107752|NCT01629862|BG001|Baseline|Sham CPAP|"Sham (non-therapeutic) continuous positive airway pressure.~Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia)."
11107753|NCT01629862|BG002|Baseline|Total|Total of all reporting groups
11107754|NCT01629862|FG000|Participant Flow|Active CPAP|"Therapeutic continuous positive airway pressure (CPAP).~Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia)."
11107755|NCT01629862|FG001|Participant Flow|Sham CPAP|"Sham (non-therapeutic) continuous positive airway pressure.~Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia)."
11107756|NCT01629862|OG000|Outcome|Active CPAP|"Therapeutic continuous positive airway pressure (CPAP).~Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia)."
11107757|NCT01629862|OG001|Outcome|Sham CPAP|"Sham (non-therapeutic) continuous positive airway pressure.~Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia)."
11107758|NCT01629862|EG000|Reported Event|Active CPAP|"Therapeutic continuous positive airway pressure (CPAP).~Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia)."
11107759|NCT01629862|EG001|Reported Event|Sham CPAP|"Sham (non-therapeutic) continuous positive airway pressure.~Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia)."
11107760|NCT01629953|BG000|Baseline|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
11107761|NCT01629953|BG001|Baseline|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
11107762|NCT01629953|BG002|Baseline|Total|Total of all reporting groups
11107763|NCT01629953|FG000|Participant Flow|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
11107764|NCT01629953|FG001|Participant Flow|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
11107765|NCT01629953|OG000|Outcome|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
11107766|NCT01629953|OG001|Outcome|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
11107767|NCT01629953|EG000|Reported Event|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
11107768|NCT01629953|EG001|Reported Event|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
11107769|NCT01629966|BG000|Baseline|Placebo|Dose-matched placebo one per day, oral administration
11107770|NCT01629966|BG001|Baseline|Vilazadone 20mg|Vilazodone 20mg once per day, oral administration.
11107771|NCT01629966|BG002|Baseline|Vilazodone 40mg|Vilazodone 40mg once per day, oral administration
11107772|NCT01629966|BG003|Baseline|Total|Total of all reporting groups
11107773|NCT01629966|FG000|Participant Flow|Placebo|Dose-matched placebo one per day, oral administration
11107774|NCT01629966|FG001|Participant Flow|Vilazadone 20mg|Vilazodone 20mg once per day, oral administration.
11107775|NCT01629966|FG002|Participant Flow|Vilazodone 40mg|Vilazodone 40mg once per day, oral administration
11107776|NCT01629966|OG000|Outcome|Placebo|Dose-matched placebo one per day, oral administration
11107777|NCT01629966|OG001|Outcome|Vilazadone 20mg|Vilazodone 20mg once per day, oral administration.
11107778|NCT01629966|OG002|Outcome|Vilazodone 40mg|Vilazodone 40mg once per day, oral administration
11107779|NCT01629966|EG000|Reported Event|Placebo|Dose-matched placebo one per day, oral administration
11107780|NCT01629966|EG001|Reported Event|Vilazadone 20mg|Vilazodone 20mg once per day, oral administration.
11107781|NCT01629966|EG002|Reported Event|Vilazodone 40mg|Vilazodone 40mg once per day, oral administration
11126623|NCT01734525|BG000|Baseline|Anidulafungin|"Patients at risk will receive therapy with anidulafungin~Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards"
11126624|NCT01734525|FG000|Participant Flow|Anidulafungin|"Patients at risk will receive therapy with anidulafungin~Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards"
11126625|NCT01734525|OG000|Outcome|Anidulafungin|"Patients at risk will receive therapy with anidulafungin~Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards"
11126626|NCT01734525|EG000|Reported Event|One Arm|"Patients at risk will receive therapy with anidulafungin~Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards"
11126627|NCT01734551|BG000|Baseline|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
11126628|NCT01734551|BG001|Baseline|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
11126629|NCT01734551|BG002|Baseline|Total|Total of all reporting groups
11126630|NCT01734551|FG000|Participant Flow|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
11126631|NCT01734551|FG001|Participant Flow|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
11107782|NCT01630109|BG000|Baseline|Metoclopramide 5 mg|Pro-motility agent
11107783|NCT01630109|BG001|Baseline|Metoclopramide 10 mg|Pro-motility agent
11107784|NCT01630109|BG002|Baseline|Placebo Control|Placebo to be used as the control group
11107785|NCT01630109|BG003|Baseline|Total|Total of all reporting groups
11107786|NCT01630109|FG000|Participant Flow|Metoclopramide 5 mg|Pro-motility agent
11107787|NCT01630109|FG001|Participant Flow|Metoclopramide 10 mg|Pro-motility agent
11107788|NCT01630109|FG002|Participant Flow|Placebo Control|Placebo to be used as the control group
11107789|NCT01630109|OG000|Outcome|Metoclopramide 5 mg|Pro-motility agent
11107790|NCT01630109|OG001|Outcome|Metoclopramide 10 mg|Pro-motility agent
11107791|NCT01630109|OG002|Outcome|Placebo Control|Placebo to be used as the control group
11107792|NCT01630109|OG000|Outcome|Metoclopramide 5 mg (Diabetics)|Pro-motility agent given to diabetic patients
11107793|NCT01630109|OG001|Outcome|Metoclopramide 10 mg (Diabetics)|Pro-motility agent given to diabetic patients
11107794|NCT01630109|OG002|Outcome|Placebo Control (Diabetics)|Placebo to be used as the control group in diabetic patients
11107795|NCT01630109|OG003|Outcome|Metoclopramide 5 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
11107796|NCT01630109|OG004|Outcome|Metoclopramide 10 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
11107797|NCT01630109|OG005|Outcome|Placebo (Non-diabetic)|Placebo control given to non-diabetics
11107798|NCT01630109|EG000|Reported Event|Metoclopramide 5 mg|Pro-motility agent
11107799|NCT01630109|EG001|Reported Event|Metoclopramide 10 mg|Pro-motility agent
11107800|NCT01630109|EG002|Reported Event|Placebo Control|Placebo to be used as the control group
11107801|NCT01630135|BG000|Baseline|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
11107802|NCT01630135|BG001|Baseline|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
11107803|NCT01630135|BG002|Baseline|Total|Total of all reporting groups
11107804|NCT01630135|FG000|Participant Flow|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
11107805|NCT01630135|FG001|Participant Flow|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
11107806|NCT01630135|OG000|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
11107807|NCT01630135|OG001|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
11107808|NCT01630135|EG000|Reported Event|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
11107809|NCT01630135|EG001|Reported Event|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
11107810|NCT01630200|BG000|Baseline|Roflumilast|"Active arm including patients who receive the study drug (500µg Roflumilast once daily)~Roflumilast: Roflumilast coated tablet, 500µg oral application, once daily in the morning"
11107811|NCT01630200|BG001|Baseline|Placebo|"Control arm including patients who receive the placebo tablet (once daily)~Placebo: Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning"
11107812|NCT01630200|BG002|Baseline|Total|Total of all reporting groups
11107813|NCT01630200|FG000|Participant Flow|Roflumilast|"Active arm including patients who receive the study drug (500µg Roflumilast once daily)~Roflumilast: Roflumilast coated tablet, 500µg oral application, once daily in the morning"
11107814|NCT01630200|FG001|Participant Flow|Placebo|"Control arm including patients who receive the placebo tablet (once daily)~Placebo: Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning"
11107815|NCT01630200|OG000|Outcome|Roflumilast|"Active arm including patients who receive the study drug (500µg Roflumilast once daily)~Roflumilast: Roflumilast coated tablet, 500µg oral application, once daily in the morning"
11107816|NCT01630200|OG001|Outcome|Placebo|"Control arm including patients who receive the placebo tablet (once daily)~Placebo: Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning"
11107817|NCT01630200|EG000|Reported Event|Roflumilast|"Active arm including patients who receive the study drug (500µg Roflumilast once daily)~Roflumilast: Roflumilast coated tablet, 500µg oral application, once daily in the morning"
11107818|NCT01630200|EG001|Reported Event|Placebo|"Control arm including patients who receive the placebo tablet (once daily)~Placebo: Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning"
11107819|NCT01630616|BG000|Baseline|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
11107820|NCT01630616|BG001|Baseline|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
11107821|NCT01630616|BG002|Baseline|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
11107822|NCT01630616|BG003|Baseline|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
11107823|NCT01630616|BG004|Baseline|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
11107824|NCT01630616|BG005|Baseline|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
11107825|NCT01630616|BG006|Baseline|Total|Total of all reporting groups
11107826|NCT01630616|FG000|Participant Flow|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
11107827|NCT01630616|FG001|Participant Flow|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
11107828|NCT01630616|FG002|Participant Flow|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
11107829|NCT01630616|FG003|Participant Flow|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
11107830|NCT01630616|FG004|Participant Flow|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
11107831|NCT01630616|FG005|Participant Flow|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
11107832|NCT01630616|OG000|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
11107833|NCT01630616|OG001|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
11107834|NCT01630616|OG002|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
11107835|NCT01630616|OG003|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
11107836|NCT01630616|OG004|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
11107837|NCT01630616|OG003|Outcome|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
11107838|NCT01630616|OG004|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
11107839|NCT01630616|OG005|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
11107840|NCT01630616|OG001|Outcome|Adolescents Odanacatib 50|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
11107841|NCT01630616|EG000|Reported Event|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
11107842|NCT01630616|EG001|Reported Event|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
11107843|NCT01630616|EG002|Reported Event|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
11107844|NCT01630616|EG003|Reported Event|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
11107845|NCT01630616|EG004|Reported Event|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
11107846|NCT01630616|EG005|Reported Event|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
11107847|NCT01630694|BG000|Baseline|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
11107848|NCT01630694|BG001|Baseline|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
11107849|NCT01630694|BG002|Baseline|Total|Total of all reporting groups
11107850|NCT01630694|FG000|Participant Flow|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
11107851|NCT01630694|FG001|Participant Flow|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
11107852|NCT01630694|OG000|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
11107853|NCT01630694|OG001|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
11107854|NCT01630694|EG000|Reported Event|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
11107855|NCT01630694|EG001|Reported Event|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
11107856|NCT01630811|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) or Placebo tablet (matching Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg)
11107857|NCT01630811|FG000|Participant Flow|Nuedexta First Placebo Second|Participants first received Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. After a washout period of 4 weeks, they then received Placebo tablet (matching Neudexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
11107858|NCT01630811|FG001|Participant Flow|Placebo First Nuedexta Second|Participants first received Placebo tablet (matching Neudexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. After a washout period of 4 weeks, they then received Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
11107859|NCT01630811|OG000|Outcome|Nuedexta|Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
11107860|NCT01630811|OG001|Outcome|Placebo|Oral, one time daily for 7 days.
11107861|NCT01630811|OG001|Outcome|Placebo|Placebo tablet equivalent to Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
11107862|NCT01630811|OG001|Outcome|Placebo|Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
11107863|NCT01630811|EG000|Reported Event|Nuedexta|Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
11107864|NCT01630811|EG001|Reported Event|Placebo|Placebo tablet equivalent to Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
11107865|NCT01630889|BG000|Baseline|Roxadustat|Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
11107866|NCT01630889|FG000|Participant Flow|Roxadustat|Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 grams (g)/deciliter (dL). However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining hemoglobin (Hb) then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
11107867|NCT01630889|OG000|Outcome|Roxadustat|Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
11107868|NCT01630889|EG000|Reported Event|Roxadustat|Participants previously randomized to roxadustat received roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments were implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 g/dL. However, if a participant, at any dose, experienced an event of excessive hematopoiesis then the participant's dose was immediately reduced, or an event of rapidly declining Hb then the participant's dose was immediately increased. Participants were permitted to receive roxadustat for up to 8 years.
11107869|NCT01631071|BG000|Baseline|Elderly Subjects Aged Over 60 Years|
11107870|NCT01631071|BG001|Baseline|Adults From 18 to 60 Years Old Inclusive|
11107871|NCT01631071|BG002|Baseline|Total|Total of all reporting groups
11107872|NCT01631071|FG000|Participant Flow|Elderly Subjects Aged Over 60 Years|
11107873|NCT01631071|FG001|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
11107874|NCT01631071|OG000|Outcome|Elderly Subjects Aged Over 60 Years|
11107875|NCT01631071|OG001|Outcome|Adults From 18 to 60 Years Old Inclusive|
11107876|NCT01631071|EG000|Reported Event|Elderly Subjects Aged Over 60 Years|
11107877|NCT01631071|EG001|Reported Event|Adults From 18 to 60 Years Old Inclusive|
11107878|NCT01631110|BG000|Baseline|Elderly Subjects Aged Over 60 Years|
11107879|NCT01631110|BG001|Baseline|Adults From 18 to 60 Years Old Inclusive|
11107880|NCT01631110|BG002|Baseline|Total|Total of all reporting groups
11107881|NCT01631110|FG000|Participant Flow|Elderly Subjects Aged Over 60 Years|
11107882|NCT01631110|FG001|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
11107883|NCT01631110|OG000|Outcome|Elderly Subjects Aged Over 60 Years|
11107884|NCT01631110|OG001|Outcome|Adults From 18 to 60 Years Old Inclusive|
11107885|NCT01631110|EG000|Reported Event|Elderly Subjects Aged Over 60 Years|
11107886|NCT01631110|EG001|Reported Event|Adults From 18 to 60 Years Old Inclusive|
11107887|NCT01631149|BG000|Baseline|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
11107888|NCT01631149|BG001|Baseline|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
11107889|NCT01631149|BG002|Baseline|Total|Total of all reporting groups
11107890|NCT01631149|FG000|Participant Flow|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
11107891|NCT01631149|FG001|Participant Flow|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
11107892|NCT01631149|OG000|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
11107893|NCT01631149|OG001|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
11107894|NCT01631149|EG000|Reported Event|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
11107895|NCT01631149|EG001|Reported Event|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
11107896|NCT01631188|BG000|Baseline|Aortic Valve Replacement|"During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.~Minimally Invasive Aortic Valve: Patients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.~Minimally Invasive Aortic Valve Surgery: The Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine~Manipulation in OR surgical technique: Endovent and pacing wire when coming off cardiopulmonary bypass"
11107897|NCT01631188|FG000|Participant Flow|Aortic Valve Replacement|"During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.~Minimally Invasive Aortic Valve: Patients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.~Minimally Invasive Aortic Valve Surgery: The Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine~Manipulation in OR surgical technique: Endovent and pacing wire when coming off cardiopulmonary bypass"
11107898|NCT01631188|OG000|Outcome|Aortic Valve Replacement|"During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.~Minimally Invasive Aortic Valve: Patients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.~Minimally Invasive Aortic Valve Surgery: The Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine~Manipulation in OR surgical technique: Endovent and pacing wire when coming off cardiopulmonary bypass"
11107899|NCT01631188|EG000|Reported Event|Aortic Valve Replacement|"During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.~Minimally Invasive Aortic Valve: Patients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.~Minimally Invasive Aortic Valve Surgery: The Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine~Manipulation in OR surgical technique: Endovent and pacing wire when coming off cardiopulmonary bypass"
11107900|NCT01631214|BG000|Baseline|Alendronate/Alendronate|Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
11107901|NCT01631214|BG001|Baseline|Romosozumab/Alendronate|Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
11107902|NCT01631214|BG002|Baseline|Total|Total of all reporting groups
11107903|NCT01631214|FG000|Participant Flow|Alendronate/Alendronate|Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
11107904|NCT01631214|FG001|Participant Flow|Romosozumab/Alendronate|Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
11107905|NCT01631214|OG000|Outcome|Alendronate/Alendronate|Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
11107906|NCT01631214|OG001|Outcome|Romosozumab/Alendronate|Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
11107907|NCT01631214|EG000|Reported Event|Double-blind Period: Alendronate 70 mg QW|Participants received 70 mg alendronate once a week (QW) and placebo to romosozumab subcutaneously once a month for 12 months during the double-blind treatment period.
11107908|NCT01631214|EG001|Reported Event|Double-blind Period: Romosozumab 210 mg QM|Participants received 210 mg romosozumab subcutaneously once a month (QM) and placebo to alendronate orally once a week for the first 12 months during the double-blind treatment period.
11107909|NCT01631214|EG002|Reported Event|Overall Study: Alendronate / Alendronate|Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
11107910|NCT01631214|EG003|Reported Event|Overall Study: Romosozumab / Alendronate|Participants received 210 romosozumab mg subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
11107911|NCT01631227|BG000|Baseline|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
11107912|NCT01631227|BG001|Baseline|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
11107913|NCT01631227|BG002|Baseline|Total|Total of all reporting groups
11107914|NCT01631227|FG000|Participant Flow|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
11107915|NCT01631227|FG001|Participant Flow|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
11107916|NCT01631227|OG000|Outcome|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
11107917|NCT01631227|OG001|Outcome|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
11107918|NCT01631227|EG000|Reported Event|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
11107919|NCT01631227|EG001|Reported Event|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
11107920|NCT01631331|BG000|Baseline|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
11107921|NCT01631331|FG000|Participant Flow|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
11107922|NCT01631331|OG000|Outcome|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
11107923|NCT01631331|OG000|Outcome|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
11107924|NCT01631331|EG000|Reported Event|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
11107925|NCT01631435|BG000|Baseline|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
11107926|NCT01631435|FG000|Participant Flow|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
11107927|NCT01631435|OG000|Outcome|"# Casesclassified as Active CD is Likely by CE"|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the CD capsule endoscopy(CE).~Active Crohn's disease included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as Non active Crohn's disease."
11107928|NCT01631435|OG001|Outcome|"# Casesclassified as Active CD is Likely by IC"|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the Ileo colonoscopy (IC) procedure.~Active Crohn's disease included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as Non active Crohn's disease."
11107929|NCT01631435|EG000|Reported Event|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
11107930|NCT01631474|BG000|Baseline|Low-dose Active, BID|"low dose of CB-03-01, 0.1% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107931|NCT01631474|BG001|Baseline|Medium-dose Active, BID|"medium dose of CB-03-01, 0.5% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107932|NCT01631474|BG002|Baseline|High-dose Active, QD|"high dose of CB-03-01, 1% applied once a day~CB-03-01: Topical cream, applied once a day"
11107933|NCT01631474|BG003|Baseline|High-dose Active, BID|"high dose of CB-03-01, 1% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107934|NCT01631474|BG004|Baseline|Vehicle, QD or BID|"vehicle cream, applied once or twice a day~Vehicle: Topical cream, applied once or twice a day"
11107935|NCT01631474|BG005|Baseline|Total|Total of all reporting groups
11107936|NCT01631474|FG000|Participant Flow|Low-dose Active, BID|"low dose of CB-03-01, 0.1% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107937|NCT01631474|FG001|Participant Flow|Medium-dose Active, BID|"medium dose of CB-03-01, 0.5% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107938|NCT01631474|FG002|Participant Flow|High-dose Active, QD|"high dose of CB-03-01, 1% applied once a day~CB-03-01: Topical cream, applied once a day"
11107939|NCT01631474|FG003|Participant Flow|High-dose Active, BID|"high dose of CB-03-01, 1% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107940|NCT01631474|FG004|Participant Flow|Vehicle, QD or BID|"vehicle cream, applied once or twice a day~Vehicle: Topical cream, applied once or twice a day"
11107941|NCT01631474|OG000|Outcome|Low-dose Active, BID|"low dose of CB-03-01, 0.1% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107942|NCT01631474|OG001|Outcome|Medium-dose Active, BID|"medium dose of CB-03-01, 0.5% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107943|NCT01631474|OG002|Outcome|High-dose Active, QD|"high dose of CB-03-01, 1% applied once a day~CB-03-01: Topical cream, applied once a day"
11107944|NCT01631474|OG003|Outcome|High-dose Active, BID|"high dose of CB-03-01, 1% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107945|NCT01631474|OG004|Outcome|Vehicle, QD or BID|"vehicle cream, applied once or twice a day~Vehicle: Topical cream, applied once or twice a day"
11107946|NCT01631474|EG000|Reported Event|Low-dose Active, BID|"low dose of CB-03-01, 0.1% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107947|NCT01631474|EG001|Reported Event|Medium-dose Active, BID|"medium dose of CB-03-01, 0.5% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107948|NCT01631474|EG002|Reported Event|High-dose Active, QD|"high dose of CB-03-01, 1% applied once a day~CB-03-01: Topical cream, applied once a day"
11107949|NCT01631474|EG003|Reported Event|High-dose Active, BID|"high dose of CB-03-01, 1% applied twice a day~CB-03-01: Topical cream, applied twice a day"
11107950|NCT01631474|EG004|Reported Event|Vehicle, QD or BID|"vehicle cream, applied once or twice a day~Vehicle: Topical cream, applied once or twice a day"
11107951|NCT01631552|BG000|Baseline|SG 8mg/kg|Participants received sacituzumab govitecan-hziy 8 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107952|NCT01631552|BG001|Baseline|SG 10 mg/kg|Participants received sacituzumab govitecan-hziy 10 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107953|NCT01631552|BG002|Baseline|SG 12 mg/kg|Participants received sacituzumab govitecan-hziy 12 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107954|NCT01631552|BG003|Baseline|SG 18 mg/kg|Participants received sacituzumab govitecan-hziy 18 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107955|NCT01631552|BG004|Baseline|Total|Total of all reporting groups
11107956|NCT01631552|FG000|Participant Flow|Sacituzumab Govitecan-hziy (SG) 8 mg/kg|Participants received sacituzumab govitecan-hziy (SG) 8 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107957|NCT01631552|FG001|Participant Flow|SG 10 mg/kg|Participants received sacituzumab govitecan-hziy 10 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107958|NCT01631552|FG002|Participant Flow|SG 12 mg/kg|Participants received sacituzumab govitecan-hziy 12 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107959|NCT01631552|FG003|Participant Flow|SG 18 mg/kg|Participants received sacituzumab govitecan-hziy 18 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107960|NCT01631552|OG000|Outcome|TNBC Target Population|Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
11107961|NCT01631552|OG001|Outcome|HR+/HER2- mBC Population|Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as Hormone receptor-positive/Human epidermal growth factor receptor 2-negative (HR+/HER2-), had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
11107962|NCT01631552|OG002|Outcome|mUC Population|Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
11107963|NCT01631552|OG003|Outcome|Overall Safety Population (OSP)|Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.
11107964|NCT01631552|OG001|Outcome|HR+/HER2- mBC Population|Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
11107965|NCT01631552|OG000|Outcome|TNBC Target Population (TNBC Population)|Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
11107966|NCT01631552|OG001|Outcome|HR+/HER2- mBC Population (Non-TNBC)|Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
11107967|NCT01631552|OG001|Outcome|HR+/HER2- mBC Population|Overall, 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
11107968|NCT01631552|OG000|Outcome|SG 10 mg/kg|"Participants included adults with the following tumor types:~cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non-triple-negative breast cancer, triple-negative breast cancer, and metastatic urothelial cancer.~All participants received SG 10 mg/kg of body weight by IV infusion on Days 1 and 8 of a 21-day treatment cycle."
11107969|NCT01631552|EG000|Reported Event|Overall Safety Population|All participants who were enrolled in the study and received one dose of sacituzumab govitecan-hziy (SG) at dose level of either 8 mg/kg, 10 mg/kg, 12 mg/kg, or 18 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
11107970|NCT01631630|BG000|Baseline|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
11107971|NCT01631630|BG001|Baseline|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
11107972|NCT01631630|BG002|Baseline|Total|Total of all reporting groups
11107973|NCT01631630|FG000|Participant Flow|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
11107974|NCT01631630|FG001|Participant Flow|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
11107975|NCT01631630|OG000|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
11107976|NCT01631630|OG001|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
11107977|NCT01631630|EG000|Reported Event|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
11107978|NCT01631630|EG001|Reported Event|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
11107979|NCT01631656|BG000|Baseline|Azelaic Acid Left Side Plus Laser|"Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2."
11107980|NCT01631656|BG001|Baseline|Azelaic Acid Right Side Plus Laser|"Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2."
11107981|NCT01631656|BG002|Baseline|Total|Total of all reporting groups
11107982|NCT01631656|FG000|Participant Flow|Azelaic Acid Left Side Plus Laser|"Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2."
11107983|NCT01631656|FG001|Participant Flow|Azelaic Acid Right Side Plus Laser|"Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2."
11107984|NCT01631656|OG000|Outcome|Azelaic Acid Plus Laser|"Azelaic acid 15% twice daily for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser of half the face, once at Week 2."
11107985|NCT01631656|OG001|Outcome|LASER ONLY|Laser treatment with no azelaic acid on one side of face
11107986|NCT01631656|EG000|Reported Event|Azelaic Acid Plus Laser|Azelaic acid 15% twice daily for 6 weeks on one side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.
11107987|NCT01631656|EG001|Reported Event|Laser Only|Laser treatment with no azelaic acid on one side of face
11107988|NCT01631682|BG000|Baseline|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
11107989|NCT01631682|BG001|Baseline|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10 minute break and subsequently extinction~Reactivation: subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
11107990|NCT01631682|BG002|Baseline|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
11107991|NCT01631682|BG003|Baseline|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
11107992|NCT01631682|BG004|Baseline|Total|Total of all reporting groups
11107993|NCT01631682|FG000|Participant Flow|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
11107994|NCT01631682|FG001|Participant Flow|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
11107995|NCT01631682|FG002|Participant Flow|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
11107996|NCT01631682|FG003|Participant Flow|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
11107997|NCT01631682|OG000|Outcome|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
11107998|NCT01631682|OG001|Outcome|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
11107999|NCT01631682|OG002|Outcome|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
11108000|NCT01631682|OG003|Outcome|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
11108001|NCT01631682|EG000|Reported Event|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
11108002|NCT01631682|EG001|Reported Event|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
11108003|NCT01631682|EG002|Reported Event|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
11108004|NCT01631682|EG003|Reported Event|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
11108005|NCT01631747|BG000|Baseline|Usual Care Group|"Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.~Usual Care Group: Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics."
11108006|NCT01631747|BG001|Baseline|Lifestyle Intervention Group|"Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer~Lifestyle Intervention Group: Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer"
11108007|NCT01631747|BG002|Baseline|Total|Total of all reporting groups
11108008|NCT01631747|FG000|Participant Flow|Usual Care Group|"Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.~Usual Care Group: Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics."
11108009|NCT01631747|FG001|Participant Flow|Lifestyle Intervention Group|"Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer~Lifestyle Intervention Group: Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer"
11108010|NCT01631747|OG000|Outcome|Usual Care Group|"Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.~Usual Care Group: Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics."
11108011|NCT01631747|OG001|Outcome|Lifestyle Intervention Group|"Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer~Lifestyle Intervention Group: Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer"
11108012|NCT01631747|OG001|Outcome|Lifestyle Intervention Group|"Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer~Lifestyle Intervention Group: Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer"
11108013|NCT01631747|EG000|Reported Event|Usual Care Group|"Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.~Usual Care Group: Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics."
11108014|NCT01631747|EG001|Reported Event|Lifestyle Intervention Group|"Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer~Lifestyle Intervention Group: Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer"
11108015|NCT01631812|BG000|Baseline|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
11108016|NCT01631812|FG000|Participant Flow|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
11108017|NCT01631812|OG000|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
11108018|NCT01631812|EG000|Reported Event|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
11108019|NCT01631825|BG000|Baseline|SPM 962|SPM 962 transdermal patch
11108020|NCT01631825|FG000|Participant Flow|SPM 962|SPM 962 transdermal patch
11108021|NCT01631825|OG000|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
11108022|NCT01631825|EG000|Reported Event|SPM 962|SPM 962 transdermal patch
11108023|NCT01631864|BG000|Baseline|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
11108024|NCT01631864|BG001|Baseline|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
11108025|NCT01631864|BG002|Baseline|Total|Total of all reporting groups
11108026|NCT01631864|FG000|Participant Flow|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
11108027|NCT01631864|FG001|Participant Flow|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
11108028|NCT01631864|OG000|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
11108029|NCT01631864|OG001|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
11108030|NCT01631864|EG000|Reported Event|LCZ696|LCZ696 400 mg plus placebo to Amlodipine once daily for 8 weeks
11108031|NCT01631864|EG001|Reported Event|Amlodipine|Amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
11108032|NCT01631929|BG000|Baseline|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
11108033|NCT01631929|BG001|Baseline|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
11108034|NCT01631929|BG002|Baseline|Total|Total of all reporting groups
11108035|NCT01631929|FG000|Participant Flow|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
11108036|NCT01631929|FG001|Participant Flow|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
11108037|NCT01631929|OG000|Outcome|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
11108038|NCT01631929|OG001|Outcome|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
11108039|NCT01631929|EG000|Reported Event|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
11108040|NCT01631929|EG001|Reported Event|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
11126632|NCT01734551|OG000|Outcome|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
11108041|NCT01632150|BG000|Baseline|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
11108042|NCT01632150|FG000|Participant Flow|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
11108043|NCT01632150|OG000|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
11108044|NCT01632150|OG000|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
11108045|NCT01632150|OG000|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
11108046|NCT01632150|OG000|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
11108047|NCT01632150|EG000|Reported Event|All Treated Subjects|
11108048|NCT01632202|BG000|Baseline|Seprafilm Slurry|"The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that we will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, we anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.~Seprafilm: Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC)."
11108049|NCT01632202|BG001|Baseline|Placebo|"For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.~Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline."
11108050|NCT01632202|BG002|Baseline|Total|Total of all reporting groups
11126633|NCT01734551|OG001|Outcome|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
11108051|NCT01632202|FG000|Participant Flow|Seprafilm Slurry|"The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that we will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, we anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.~Seprafilm: Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC)."
11108052|NCT01632202|FG001|Participant Flow|Placebo|"For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.~Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline."
11108053|NCT01632202|OG000|Outcome|Seprafilm Slurry|"The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that we will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, we anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.~Seprafilm: Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC)."
11108054|NCT01632202|OG001|Outcome|Placebo|"For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.~Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline."
11108055|NCT01632202|EG000|Reported Event|Seprafilm Slurry|"The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that we will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, we anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.~Seprafilm: Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC)."
11108056|NCT01632202|EG001|Reported Event|Placebo|"For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.~Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline."
11108057|NCT01632215|BG000|Baseline|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
11108058|NCT01632215|BG001|Baseline|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
11108059|NCT01632215|BG002|Baseline|Total|Total of all reporting groups
11108060|NCT01632215|FG000|Participant Flow|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
11108061|NCT01632215|FG001|Participant Flow|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
11108062|NCT01632215|OG000|Outcome|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
11108063|NCT01632215|OG001|Outcome|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
11108064|NCT01632215|EG000|Reported Event|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
11108065|NCT01632215|EG001|Reported Event|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
11108066|NCT01632241|BG000|Baseline|Placebo to Belimumab 10 mg/kg|In double-blinded phase, participants received matching placebo to belimumab administered as intravenous (IV) infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 milligram per kilogram (mg/kg) administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
11108067|NCT01632241|BG001|Baseline|Belimumab 10 mg/kg to Belimumab 10 mg/kg|In double-blinded phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
11108068|NCT01632241|BG002|Baseline|Total|Total of all reporting groups
11108069|NCT01632241|FG000|Participant Flow|Placebo to Belimumab 10 mg/kg|In double-blinded phase, participants received matching placebo to belimumab administered as intravenous (IV) infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 milligram per kilogram (mg/kg) administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
11108070|NCT01632241|FG001|Participant Flow|Belimumab 10 mg/kg to Belimumab 10 mg/kg|In double-blinded phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
11108071|NCT01632241|OG000|Outcome|Placebo (DB Phase)|In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
11108072|NCT01632241|OG001|Outcome|Belimumab 10 mg/kg (DB Phase)|In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
11108073|NCT01632241|OG000|Outcome|Placebo to Belimumab 10 mg/kg (OL Phase)|In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
11108074|NCT01632241|OG001|Outcome|Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)|In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
11108075|NCT01632241|OG001|Outcome|Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)|In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
11108076|NCT01632241|OG000|Outcome|Placebo to Belimumab 10 mg/kg (OL Phase)|In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
11108077|NCT01632241|EG000|Reported Event|Placebo (DB Phase)|In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
11108078|NCT01632241|EG001|Reported Event|Belimumab 10 mg/kg (DB Phase)|In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
11108079|NCT01632241|EG002|Reported Event|Placebo to Belimumab 10 mg/kg (OL Phase)|In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
11108080|NCT01632241|EG003|Reported Event|Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)|In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
11108081|NCT01632267|BG000|Baseline|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
11108082|NCT01632267|FG000|Participant Flow|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
11108083|NCT01632267|OG000|Outcome|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
11108084|NCT01632267|EG000|Reported Event|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
11108085|NCT01632280|BG000|Baseline|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
11108086|NCT01632280|BG001|Baseline|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
11108087|NCT01632280|BG002|Baseline|Total|Total of all reporting groups
11108088|NCT01632280|FG000|Participant Flow|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
11108089|NCT01632280|FG001|Participant Flow|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
11108090|NCT01632280|OG000|Outcome|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
11108091|NCT01632280|OG001|Outcome|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
11108092|NCT01632280|EG000|Reported Event|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
10846816|NCT00280059|EG001|Reported Event|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
11108093|NCT01632280|EG001|Reported Event|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
11108094|NCT01632306|BG000|Baseline|LY2090314 + Gemcitabine|LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m²) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
11108095|NCT01632306|BG001|Baseline|LY2090314 + FOLFOX|LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.
11108096|NCT01632306|BG002|Baseline|Total|Total of all reporting groups
11108097|NCT01632306|FG000|Participant Flow|LY2090314 + Gemcitabine|LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m²) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
11108098|NCT01632306|FG001|Participant Flow|LY2090314 + FOLFOX|LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.
11108099|NCT01632306|FG002|Participant Flow|LY2090314 + Gemcitabine + Nab-paclitaxel|LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m² gemcitabine + 125 mg/m² nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment.
11108100|NCT01632306|OG000|Outcome|LY2090314 + Gemcitabine|LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m²) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
11108101|NCT01632306|OG001|Outcome|LY2090314 + FOLFOX|LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.
11108102|NCT01632306|EG000|Reported Event|LY2090314 + Gemcitabine|LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m²) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
11108103|NCT01632306|EG001|Reported Event|LY2090314 + FOLFOX|LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.
11108104|NCT01632345|BG000|Baseline|Doravirine 25 mg: Part I/II Combined|Doravirine 25 mg once daily plus TRUVADA once daily
11108105|NCT01632345|BG001|Baseline|Doravirine 50 mg Part I/II Combined|Doravirine 50 mg once daily plus TRUVADA once daily
11108106|NCT01632345|BG002|Baseline|Doravirine 100 mg: Part I/II Combined|Doravirine 100 mg once daily plus TRUVADA once daily
11108107|NCT01632345|BG003|Baseline|Doravirine 200 mg: Part I/II Combined|Doravirine 200 mg once daily plus TRUVADA once daily
11108108|NCT01632345|BG004|Baseline|Efavirenz 600 mg: Part I/II Combined|Efavirenz 600 mg once daily plus TRUVADA once daily
11108109|NCT01632345|BG005|Baseline|Total|Total of all reporting groups
11108110|NCT01632345|FG000|Participant Flow|Part I: Doravirine 25 mg|Doravirine 25 mg once daily plus TRUVADA once daily in Part I
11108111|NCT01632345|FG001|Participant Flow|Part I: Doravirine 50 mg|Doravirine 50 mg once daily plus TRUVADA once daily in Part I
11108112|NCT01632345|FG002|Participant Flow|Part I: Doravirine 100 mg|Doravirine 100 mg once daily plus TRUVADA once daily in Part I
11108113|NCT01632345|FG003|Participant Flow|Part I: Doravirine 200 mg|Doravirine 200 mg once daily plus TRUVADA once daily in Part I
11108114|NCT01632345|FG004|Participant Flow|Part I: Efavirenz 600 mg|Efavirenz 600 mg once daily plus TRUVADA once daily in Part I
11108115|NCT01632345|FG005|Participant Flow|Part II: Doravirine 100 mg|Doravirine 100 mg once daily plus TRUVADA once daily in Part II
11108116|NCT01632345|FG006|Participant Flow|Part II: Efavirenz 600 mg|Efavirenz 600 mg once daily plus TRUVADA once daily in Part II
11108117|NCT01632345|OG000|Outcome|Doravirine 25 mg: Part I|Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
11108118|NCT01632345|OG001|Outcome|Doravirine 50 mg: Part I|Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
11108119|NCT01632345|OG002|Outcome|Doravirine 100 mg : Part I|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
11108120|NCT01632345|OG003|Outcome|Doravirine 200 mg: Part I|Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
11108121|NCT01632345|OG004|Outcome|Efavirenz 600 mg: Part I|Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
11108122|NCT01632345|OG002|Outcome|Doravirine 100 mg: Part I|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
11108123|NCT01632345|OG000|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
11108124|NCT01632345|OG001|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
11108125|NCT01632345|EG000|Reported Event|Doravirine 25 mg (n=40)|Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
11108126|NCT01632345|EG001|Reported Event|Doravirine 50 mg (n=43)|Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
11108127|NCT01632345|EG002|Reported Event|Doravirine 100 mg (n=108)|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I & Part II (Combined)
11108128|NCT01632345|EG003|Reported Event|Doravirine 200 mg (n=41)|Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
11108129|NCT01632345|EG004|Reported Event|Efavirenz 600 mg: Part I (n=108)|Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I & Part II (Combined)
11108130|NCT01632423|BG000|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
11108131|NCT01632423|FG000|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
11108132|NCT01632423|OG000|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
11108133|NCT01632423|EG000|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
11108134|NCT01632566|BG000|Baseline|25 mg LY3031207|Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
11108135|NCT01632566|BG001|Baseline|75 mg LY3031207 and Simvastatin|Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108136|NCT01632566|BG002|Baseline|225 mg LY3031207 and Simvastatin|Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
11108137|NCT01632566|BG003|Baseline|Placebo With or Without Simvastatin|Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108138|NCT01632566|BG004|Baseline|400 mg Celecoxib With or Without Simvastatin|Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108139|NCT01632566|BG005|Baseline|Total|Total of all reporting groups
11108140|NCT01632566|FG000|Participant Flow|25 mg LY3031207|Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
11108141|NCT01632566|FG001|Participant Flow|75 mg LY3031207 and Simvastatin|Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108142|NCT01632566|FG002|Participant Flow|225 mg LY3031207 and Simvastatin|Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
11108143|NCT01632566|FG003|Participant Flow|Placebo With or Without Simvastatin|Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108144|NCT01632566|FG004|Participant Flow|400 mg Celecoxib With or Without Simvastatin|Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108145|NCT01632566|OG000|Outcome|25 mg LY3031207|Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
11108146|NCT01632566|OG001|Outcome|75 mg LY3031207 and Simvastatin|Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108147|NCT01632566|OG002|Outcome|225 mg LY3031207 and Simvastatin|Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
11108148|NCT01632566|OG003|Outcome|Placebo With or Without Simvastatin|Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108149|NCT01632566|OG004|Outcome|400 mg Celecoxib With or Without Simvastatin|Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108150|NCT01632566|OG005|Outcome|10 mg Simvastatin|Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
11108151|NCT01632566|OG000|Outcome|10 mg Simvastatin Day -3|Oral administration of 10 mg open-label simvastatin on Day -3 for participants randomized to 75 mg LY3031207, 225 mg LY3031207, placebo, or celecoxib.
11108152|NCT01632566|OG001|Outcome|10 mg Simvastatin Day 28|Oral administration of 10 mg open-label simvastatin on Day 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207, placebo, or celecoxib.
11108153|NCT01632566|EG000|Reported Event|Placebo With or Without Simvastatin|Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
10846817|NCT00280150|BG000|Baseline|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
10846818|NCT00280150|BG001|Baseline|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
11108154|NCT01632566|EG001|Reported Event|25 mg LY3031207|Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
11108155|NCT01632566|EG002|Reported Event|75 mg LY3031207 and Simvastatin|Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108156|NCT01632566|EG003|Reported Event|225 mg LY3031207 and Simvastatin|Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
11108157|NCT01632566|EG004|Reported Event|400 mg Celecoxib With or Without Simvastatin|Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
11108158|NCT01632566|EG005|Reported Event|10 mg Simvastatin|Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
11108159|NCT01632579|BG000|Baseline|Entire Study Population|Depending on the cohort and period, participants received either an LY3023703 capsule (0.1-mg, 0.5-mg, 2.5-mg, 10-mg, 30-mg, or 60-mg strength) or placebo administered orally once in Periods 1 and 2. In Period 3, participants were administered 400 mg celecoxib, orally. Each dose of study drug was followed by a washout period of at least 3 weeks.
11108160|NCT01632579|FG000|Participant Flow|Cohort 1 Sequence 1|"Participants received LY3023703, placebo and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: 0.1 mg LY3023703 in week 1, Period 2: Placebo in week 4 and Period 3: 400mg celecoxib in week 8."
11108161|NCT01632579|FG001|Participant Flow|Cohort 1 Sequence 2|"Participants received LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: 0.1 mg LY3023703 in week 1, Period 2: 10 mg LY3023703 in week 4 and Period 3: 400mg celecoxib in week 7."
11108162|NCT01632579|FG002|Participant Flow|Cohort 1 Sequence 3|"Participants received placebo, LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: Placebo in week 1, Period 2: 10 mg LY3023703 in week 4 and Period 3: 400mg celecoxib in week 7."
11108163|NCT01632579|FG003|Participant Flow|Cohort 2 Sequence 1|"Participants received LY3023703, placebo and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: 0.5 mg LY3023703 in week 2, Period 2: Placebo in week 5 and Period 3: 400mg celecoxib in week 8."
11108164|NCT01632579|FG004|Participant Flow|Cohort 2 Sequence 2|"Participants received LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: 0.5 mg LY3023703 in week 2, Period 2: 30 mg LY3023703 in week 5 and Period 3: 400mg celecoxib in week 8."
11108165|NCT01632579|FG005|Participant Flow|Cohort 2 Sequence 3|"Participants received placebo, LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: Placebo in week 2, Period 2: 30 mg LY3023703 in week 5 and Period 3: 400mg celecoxib in week 8."
11108166|NCT01632579|FG006|Participant Flow|Cohort 3 Sequence 1|"Participants received LY3023703, placebo and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: 2.5 mg LY3023703 in week 3, Period 2: Placebo in week 6 and Period 3: 400mg celecoxib in week 9."
11108167|NCT01632579|FG007|Participant Flow|Cohort 3 Sequence 2|"Participants received LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: 2.5 mg LY3023703 in week 3, Period 2: 60 mg LY3023703 in week 6 and Period 3: 400mg celecoxib in week 9."
11108168|NCT01632579|FG008|Participant Flow|Cohort 3 Sequence 3|"Participants received placebo, LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.~Period 1: Placebo in week 3, Period 2: 60 mg LY3023703 in week 6 and Period 3: 400mg celecoxib in week 9."
11108169|NCT01632579|OG000|Outcome|Placebo|Matched placebo capsules administered orally in Periods 1 or 2.
11108170|NCT01632579|OG001|Outcome|0.1 mg LY3023703|0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
11108171|NCT01632579|OG002|Outcome|0.5 mg LY3023703|0.5-mg LY3023703 capsule administered orally, once in Period 1.
11108172|NCT01632579|OG003|Outcome|2.5 mg LY3023703|2.5-mg LY3023703 capsule administered orally, once in Period 1.
11108173|NCT01632579|OG004|Outcome|10 mg LY3023703|10-mg LY3023703 capsule administered orally, once in Period 2.
11108174|NCT01632579|OG005|Outcome|30 mg LY3023703|30-mg LY3023703 capsule administered orally, once in Period 2.
11108175|NCT01632579|OG006|Outcome|60 mg LY3023703|60-mg LY3023703 capsule administered orally, once in Period 2.
11108176|NCT01632579|OG007|Outcome|Celecoxib|400-mg celecoxib dose (two 200-mg celecoxib capsules) administered orally, once in Period 3.
11108177|NCT01632579|OG000|Outcome|0.1 mg LY3023703|0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
10846819|NCT00280150|BG002|Baseline|Cohort 3|Bevacizumab + Erlotinib 150 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
11108178|NCT01632579|OG001|Outcome|0.5 mg LY3023703|0.5-mg LY3023703 capsule administered orally, once in Period 1.
11108179|NCT01632579|OG002|Outcome|2.5 mg LY3023703|2.5-mg LY3023703 capsule administered orally, once in Period 1.
11108180|NCT01632579|OG003|Outcome|10 mg LY3023703|10-mg LY3023703 capsule administered orally, once in Period 2.
11108181|NCT01632579|OG004|Outcome|30 mg LY3023703|30-mg LY3023703 capsule administered orally, once in Period 2.
11108182|NCT01632579|OG005|Outcome|60 mg LY3023703|60-mg LY3023703 capsule administered orally, once in Period 2.
11108183|NCT01632579|EG000|Reported Event|Placebo|Matched placebo capsules administered orally in Periods 1 or 2.
11108184|NCT01632579|EG001|Reported Event|LY3023703 0.1 mg|0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
11108185|NCT01632579|EG002|Reported Event|LY3023703 0.5 mg|0.5-mg LY3023703 capsule administered orally, once in Period 1.
11108186|NCT01632579|EG003|Reported Event|LY3023703 2.5 mg|2.5-mg LY3023703 capsule administered orally, once in Period 1.
11108187|NCT01632579|EG004|Reported Event|LY3023703 10 mg|10-mg LY3023703 capsule administered orally, once in Period 2.
11108188|NCT01632579|EG005|Reported Event|LY3023703 30 mg|30-mg LY3023703 capsule administered orally, once in Period 2.
11108189|NCT01632579|EG006|Reported Event|LY3023703 60 mg|60-mg LY3023703 capsule administered orally, once in Period 2.
11108190|NCT01632579|EG007|Reported Event|Celecoxib|400-mg celecoxib capsule, administered orally, once in Period 3.
11108191|NCT01632683|BG000|Baseline|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
11108192|NCT01632683|BG001|Baseline|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
11108193|NCT01632683|BG002|Baseline|Total|Total of all reporting groups
11108194|NCT01632683|FG000|Participant Flow|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
11108195|NCT01632683|FG001|Participant Flow|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
11108196|NCT01632683|OG000|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
11108197|NCT01632683|OG001|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
11108198|NCT01632683|EG000|Reported Event|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
11108199|NCT01632683|EG001|Reported Event|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
11108200|NCT01632709|BG000|Baseline|Sympathetic Nerve Block of Bupivacaine|
11108201|NCT01632709|BG001|Baseline|Dry Needling at Sympathetic Ganglion|
11108202|NCT01632709|BG002|Baseline|Neuroma Injection of Bupivacaine|
11108203|NCT01632709|BG003|Baseline|Dry Needling at the Neuroma|
11108204|NCT01632709|BG004|Baseline|Total|Total of all reporting groups
11108205|NCT01632709|FG000|Participant Flow|Sympathetic Nerve Block of Bupivacaine|
11108206|NCT01632709|FG001|Participant Flow|Dry Needling at Sympathetic Ganglion|
11108207|NCT01632709|FG002|Participant Flow|Neuroma Injection of Bupivacaine|
11108208|NCT01632709|FG003|Participant Flow|Dry Needling at the Neuroma|
11108209|NCT01632709|OG000|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
11108210|NCT01632709|OG001|Outcome|Dry Needling|Placebo: Dry needling
11108211|NCT01632709|OG002|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
11108212|NCT01632709|OG003|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
11108213|NCT01632709|EG000|Reported Event|Placebo/Sham Injection|
11108214|NCT01632709|EG001|Reported Event|Treatment Group|
11108215|NCT01632735|BG000|Baseline|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
11108216|NCT01632735|BG001|Baseline|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
11108217|NCT01632735|BG002|Baseline|Total|Total of all reporting groups
11108218|NCT01632735|FG000|Participant Flow|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
11108219|NCT01632735|FG001|Participant Flow|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
11108220|NCT01632735|OG000|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
11108221|NCT01632735|OG001|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
11108222|NCT01632735|EG000|Reported Event|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
11108223|NCT01632735|EG001|Reported Event|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
11108224|NCT01632800|BG000|Baseline|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
11108225|NCT01632800|FG000|Participant Flow|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
11108226|NCT01632800|OG000|Outcome|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
11108227|NCT01632800|EG000|Reported Event|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
11108228|NCT01632891|BG000|Baseline|LPV/R-based ART|Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
11108229|NCT01632891|BG001|Baseline|nNRTI-based ART|Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
11108230|NCT01632891|BG002|Baseline|Total|Total of all reporting groups
11108231|NCT01632891|FG000|Participant Flow|LPV/R-based ART|Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
11108232|NCT01632891|FG001|Participant Flow|nNRTI-based ART|Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
11108233|NCT01632891|OG000|Outcome|LPV/R-based ART|Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
11108234|NCT01632891|OG001|Outcome|nNRTI-based ART|Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
11108235|NCT01632891|OG000|Outcome|nNRTI-based ART, Not Cleared|Randomized to nNRTI based ART with continued Pf SCP at day 15
11108236|NCT01632891|OG001|Outcome|nNRTI-based ART, Cleared|Randomized to nNRTI based ART with clearance of Pf SCP at day 15
11108237|NCT01632891|OG002|Outcome|LPV/R-based ART, Not Cleared|Randomized to LPV/r based ART with continued Pf SCP at day 15
11108238|NCT01632891|OG003|Outcome|LPV/R-based ART, Cleared|Randomized to LPV/r based ART with clearance of Pf SCP at day 15
11108239|NCT01632891|EG000|Reported Event|LPV/R-based ART|Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
11108240|NCT01632891|EG001|Reported Event|nNRTI-based ART|Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
11108241|NCT01632904|BG000|Baseline|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
11108242|NCT01632904|BG001|Baseline|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
11108243|NCT01632904|BG002|Baseline|Total|Total of all reporting groups
11108244|NCT01632904|FG000|Participant Flow|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
11108245|NCT01632904|FG001|Participant Flow|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
11108246|NCT01632904|OG000|Outcome|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
11108247|NCT01632904|OG001|Outcome|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
11108248|NCT01632904|EG000|Reported Event|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
11108249|NCT01632904|EG001|Reported Event|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
11108250|NCT01632995|BG000|Baseline|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
11108251|NCT01632995|FG000|Participant Flow|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
11108252|NCT01632995|OG000|Outcome|Participants Assessed for Participation|All participants who were assessed for study participation
11108253|NCT01632995|OG000|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
11108254|NCT01632995|OG000|Outcome|Participants With DBS Testing|All study participants who had at least 1 DBS result
11108255|NCT01632995|EG000|Reported Event|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
11108256|NCT01633060|BG000|Baseline|BKM120 100mg + Fulvestrant|BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
11108257|NCT01633060|BG001|Baseline|Placebo + Fulvestrant|BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
11108258|NCT01633060|BG002|Baseline|Total|Total of all reporting groups
11108259|NCT01633060|FG000|Participant Flow|BKM120 100mg + Fulvestrant|BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
11108260|NCT01633060|FG001|Participant Flow|Placebo + Fulvestrant|BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
11108261|NCT01633060|OG000|Outcome|BKM120 100mg + Fulvestrant|BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
11108262|NCT01633060|OG001|Outcome|Placebo + Fulvestrant|BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
11108263|NCT01633060|EG000|Reported Event|BKM120 100 mg + Fulvestrant|BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol test.
11108264|NCT01633060|EG001|Reported Event|Placebo + Fulvestrant|BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
11108265|NCT01633060|EG002|Reported Event|All Patients|All Patients
11108266|NCT01633112|BG000|Baseline|FTY720 0.5 mg|Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months
11108267|NCT01633112|BG001|Baseline|FTY720 0.25 mg|Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months
11108268|NCT01633112|BG002|Baseline|GA 20 mg|Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
11108269|NCT01633112|BG003|Baseline|Total|Total of all reporting groups
11108270|NCT01633112|FG000|Participant Flow|FTY720 0.5 mg|Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months
10846820|NCT00280150|BG003|Baseline|Phase II|Bevacizumab + Erlotinib100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
11108271|NCT01633112|FG001|Participant Flow|FTY720 0.25 mg|Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months
11108272|NCT01633112|FG002|Participant Flow|GA 20 mg|Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
11108273|NCT01633112|OG000|Outcome|FTY720 0.5 mg|Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months
11108274|NCT01633112|OG001|Outcome|FTY720 0.25 mg|Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months
11108275|NCT01633112|OG002|Outcome|GA 20 mg|Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
11108276|NCT01633112|EG000|Reported Event|Fingolimod 0.5 mg|Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months
11108277|NCT01633112|EG001|Reported Event|FTY 0.25 mg|Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months
11108278|NCT01633112|EG002|Reported Event|GA 20 mg|Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months
11108279|NCT01633112|EG003|Reported Event|All@Patients|All patients in the trial
11108280|NCT01633320|BG000|Baseline|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
11108281|NCT01633320|BG001|Baseline|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
11108282|NCT01633320|BG002|Baseline|Total|Total of all reporting groups
11108283|NCT01633320|FG000|Participant Flow|NRS<=3 (no or Mild Pain)|Patients with numerical rating pain scale <=3 at arrival in PACU
11108284|NCT01633320|FG001|Participant Flow|NRS>3 (Moderate to Severe Pain)|Patients with numerical rating scale pain score >3 at arrival in PACU
11108285|NCT01633320|OG000|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
11108286|NCT01633320|OG001|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
11108287|NCT01633320|EG000|Reported Event|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
11108288|NCT01633320|EG001|Reported Event|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
11108289|NCT01633398|BG000|Baseline|HFrEF|ejection fraction <40%
10846821|NCT00280150|BG004|Baseline|Total|Total of all reporting groups
11108290|NCT01633398|BG001|Baseline|HFpEF|ejection fraction ≥50%
11108291|NCT01633398|BG002|Baseline|Total|Total of all reporting groups
11108292|NCT01633398|FG000|Participant Flow|HFrEF|ejection fraction <40%
11108293|NCT01633398|FG001|Participant Flow|HFpEF|ejection fraction ≥50%
11108294|NCT01633398|OG000|Outcome|HFrEF|ejection fraction <40%
11108295|NCT01633398|OG001|Outcome|HFpEF|ejection fraction ≥50%
11108296|NCT01633398|EG000|Reported Event|HFrEF|ejection fraction <40%
11108297|NCT01633398|EG001|Reported Event|HFpEF|ejection fraction ≥50%
11108298|NCT01633788|BG000|Baseline|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
11108299|NCT01633788|BG001|Baseline|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
11108300|NCT01633788|BG002|Baseline|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
11108301|NCT01633788|BG003|Baseline|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
11108302|NCT01633788|BG004|Baseline|Total|Total of all reporting groups
11108303|NCT01633788|FG000|Participant Flow|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
11108304|NCT01633788|FG001|Participant Flow|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
11108305|NCT01633788|FG002|Participant Flow|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
11108306|NCT01633788|FG003|Participant Flow|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
11108307|NCT01633788|OG000|Outcome|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
11108308|NCT01633788|OG001|Outcome|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
11108309|NCT01633788|OG002|Outcome|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
11108310|NCT01633788|OG003|Outcome|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
11108311|NCT01633788|EG000|Reported Event|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
11108312|NCT01633788|EG001|Reported Event|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
11108313|NCT01633788|EG002|Reported Event|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
11108314|NCT01633788|EG003|Reported Event|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
11108315|NCT01633827|BG000|Baseline|Study Group|"This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions.~During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject demographics for the 20 remaining unselected patients are shown below."
11108316|NCT01633827|FG000|Participant Flow|Placebo and Air First, Then Eszopiclone and Oxygen|Subjects will receive both a sugar pill and room air during two overnight sleep studies first and subsequently eszopiclone 3 mg with oxygen (FiO2 0.4) after a washout period of 1 week.
11108317|NCT01633827|FG001|Participant Flow|Eszopiclone and Oxygen First, Then Placebo and Air|Subjects will receive both eszopiclone and medical grade oxygen (FIO2 0.4) during two overnight sleep studies, after a washout period of 1 week they will receive placebo and air during two overnight sleep studies
11108318|NCT01633827|OG000|Outcome|Placebo Data|These result reports the minimum ventilation that can be tolerated before an arousal from sleep under placebo and room air administration
11108319|NCT01633827|OG001|Outcome|Treatment Data|These result reports the minimum ventilation that can be tolerated before an arousal from sleep under the conditions of oxygen and a sedative.
11108320|NCT01633827|OG000|Outcome|Placebo Data|These results report the ventilatory control sensitivity (i.e., loop gain) during placebo and room air administration
11108321|NCT01633827|OG001|Outcome|Treatment Data|These result report the ventilatory control sensitivity (i.e., loop gain) during eszopiclone and oxygen administration
11108322|NCT01633827|OG000|Outcome|Placebo Data|These results represent the ventilation through a passive airway (when pharyngeal dilator muscles are not recruited) at atmospheric pressure and eupneic ventilatory drive during the administration of placebo and room air
11108323|NCT01633827|OG001|Outcome|Treatment Data|These results represent the ventilation through a passive airway (when pharyngeal dilator muscles are not recruited) at atmospheric pressure and eupneic ventilatory drive during eszopiclone and oxygen administration
11108324|NCT01633827|OG000|Outcome|Placebo Data|These results represent the ventilation through a active airway (when pharyngeal dilator muscles maximally recruited) at atmospheric pressure during the administration of placebo and room air
11108325|NCT01633827|OG001|Outcome|Treatment Data|These results represent the ventilation through a active airway (when pharyngeal dilator muscles maximally recruited) at atmospheric pressure during eszopiclone and oxygen administration
11108326|NCT01633827|OG000|Outcome|Placebo Data|This result reports the AHI under the conditions of room air and a placebo tablet.
11108327|NCT01633827|OG001|Outcome|Treatment Data|This result reports the AHI under the conditions of oxygen and eszopiclone
11108328|NCT01633827|EG000|Reported Event|Study Group|This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions
11108329|NCT01633853|BG000|Baseline|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
11108330|NCT01633853|BG001|Baseline|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
11108331|NCT01633853|BG002|Baseline|Total|Total of all reporting groups
11108332|NCT01633853|FG000|Participant Flow|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
11108333|NCT01633853|FG001|Participant Flow|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
11108334|NCT01633853|OG000|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
11108335|NCT01633853|OG001|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
11108336|NCT01633853|OG000|Outcome|Vitamin D2 Treatment|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
11108337|NCT01633853|EG000|Reported Event|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
11108338|NCT01633853|EG001|Reported Event|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
11108339|NCT01633892|BG000|Baseline|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
11108340|NCT01633892|FG000|Participant Flow|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
11108341|NCT01633892|OG000|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
10846822|NCT00280150|FG000|Participant Flow|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy
11108342|NCT01633892|EG000|Reported Event|Fat Grafting|"Autologous fat grafting is a potential solution. Grafting of autologous fat tissue is a minimally invasive surgical technique that starts with the harvest of fat tissue from the abdomen or thighs using liposuction through incisions less than 5mm in length. The lipoaspirate is then processed to concentrate the adipose fraction and reinjected into the donor site. This surgical procedure involves the immediate transplantation of a patient's own tissue in a single operative procedure. It has the advantages of:~Minimal access incisions~Ability to transfer significant amounts of tissue (hundreds of grams of tissue)~Can be used in setting of previous surgical procedures and presence of hardware~Usually performed as outpatient procedure~Minimal donor site morbidity at graft harvest site~Low risk compared with more invasive surgical procedures~Can be repeated multiple times, if necessary, even using the same donor site"
11108343|NCT01633944|BG000|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
11108344|NCT01633944|BG001|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
11108345|NCT01633944|BG002|Baseline|Total|Total of all reporting groups
11108346|NCT01633944|FG000|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
11108347|NCT01633944|FG001|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
11108348|NCT01633944|FG002|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
11108349|NCT01633944|OG000|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
11108350|NCT01633944|OG001|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
11108351|NCT01633944|OG000|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
11108352|NCT01633944|EG000|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 75, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration treatment phase
11108353|NCT01633944|EG001|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
11108354|NCT01633944|EG002|Reported Event|DB Placebo Film|Placebo buccal film, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
11108355|NCT01634100|BG000|Baseline|Study Overall|This was a randomised, 3-way crossover trial. 18 patients were randomised to one of six treatment sequences and treated. It was an open label trial in which each treatment period lasted 4 days with a washout period of at least 7 days between each.
11108356|NCT01634100|FG000|Participant Flow|Empa Alone / Empa + Rifampicin / Empa + Probenecid|"Patients were administered three treatments in the following order:~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
11108357|NCT01634100|FG001|Participant Flow|Empa Alone / Empa + Probenecid / Empa + Rifampicin|"Patients were administered three treatments in the following order:~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
11108358|NCT01634100|FG002|Participant Flow|Empa + Rifampicin / Empa Alone / Empa + Probenecid|"Patients were administered three treatments in the following order:~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
11108359|NCT01634100|FG003|Participant Flow|Empa + Rifampicin / Empa + Probenecid / Empa Alone|"Patients were administered three treatments in the following order:~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa Alone (A single dose of 10mg of empagliflozin (empa))"
11108360|NCT01634100|FG004|Participant Flow|Empa + Probenecid / Empa Alone / Empa + Rifampicin|"Patients were administered three treatments in the following order:~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
11108361|NCT01634100|FG005|Participant Flow|Empa + Probenecid / Empa + Rifampicin / Empa Alone|"Patients were administered three treatments in the following order:~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa Alone (A single dose of 10mg of empagliflozin (empa))"
11108362|NCT01634100|OG000|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
11108363|NCT01634100|OG001|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
11108364|NCT01634100|OG002|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
10846823|NCT00280150|FG001|Participant Flow|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
11108365|NCT01634100|EG000|Reported Event|Empa Alone|A single dose of 10mg of empagliflozin (empa).
11108366|NCT01634100|EG001|Reported Event|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
11108367|NCT01634100|EG002|Reported Event|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
11108368|NCT01634113|BG000|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
11108369|NCT01634113|BG001|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
11108370|NCT01634113|BG002|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
11108371|NCT01634113|BG003|Baseline|Total|Total of all reporting groups
11108372|NCT01634113|FG000|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
11108373|NCT01634113|FG001|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
11108374|NCT01634113|FG002|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
11108375|NCT01634113|OG000|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
11108376|NCT01634113|OG001|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
11108377|NCT01634113|OG002|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
11108378|NCT01634113|EG000|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
11108379|NCT01634113|EG001|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
11108380|NCT01634113|EG002|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
11108381|NCT01634139|BG000|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108382|NCT01634139|BG001|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108383|NCT01634139|BG002|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108384|NCT01634139|BG003|Baseline|Total|Total of all reporting groups
11108385|NCT01634139|FG000|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
10846824|NCT00280150|FG002|Participant Flow|Cohort 3|Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
11108386|NCT01634139|FG001|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108387|NCT01634139|FG002|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108388|NCT01634139|OG000|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108389|NCT01634139|OG001|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108390|NCT01634139|OG002|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108391|NCT01634139|EG000|Reported Event|Placebo|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108392|NCT01634139|EG001|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108393|NCT01634139|EG002|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108394|NCT01634152|BG000|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108395|NCT01634152|BG001|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108396|NCT01634152|BG002|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108397|NCT01634152|BG003|Baseline|Total|Total of all reporting groups
11108398|NCT01634152|FG000|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108399|NCT01634152|FG001|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108400|NCT01634152|FG002|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108401|NCT01634152|OG000|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108402|NCT01634152|OG001|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108403|NCT01634152|OG002|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108404|NCT01634152|EG000|Reported Event|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108405|NCT01634152|EG001|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108406|NCT01634152|EG002|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
11108407|NCT01634165|BG000|Baseline|All Participants|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016, or 0.6 U/kg LY2963016, or 0.3 U/kg Lantus, or 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
11108408|NCT01634165|FG000|Participant Flow|0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
11108409|NCT01634165|FG001|Participant Flow|0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
11108410|NCT01634165|FG002|Participant Flow|0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY|Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
11108411|NCT01634165|FG003|Participant Flow|0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY|Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
11108412|NCT01634165|OG000|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
10846825|NCT00280150|FG003|Participant Flow|Phase II|Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
11108413|NCT01634165|OG001|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
11108414|NCT01634165|OG002|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
11108415|NCT01634165|OG003|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
11108416|NCT01634165|EG000|Reported Event|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
11108417|NCT01634165|EG001|Reported Event|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
11108418|NCT01634165|EG002|Reported Event|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
11108419|NCT01634165|EG003|Reported Event|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
11108420|NCT01634178|BG000|Baseline|Apremilast|Participants received one dose of 30 mg apremilast administered under fasted conditions and one dose of 30 mg apremilast after a full fat meal.
11108421|NCT01634178|FG000|Participant Flow|Sequence 1: Apremilast Fasted / Fed|Participants were randomized to receive a single 30 mg apremilast tablet administered under fasted conditions in Period 1 and a single 30 mg apremilast tablet administered after a high fat meal in Period 2.
11108422|NCT01634178|FG001|Participant Flow|Sequence 2: Apremilast Fed / Fasted|Participants were randomized to receive a single 30 mg apremilast tablet administered after a high fat meal in Period 1 and a single 30 mg apremilast tablet administered under fasted conditions in Period 2.
11108423|NCT01634178|OG000|Outcome|Apremilast - Fasted|Participants received a single 30 mg apremilast tablet administered under fasted conditions.
11108424|NCT01634178|OG001|Outcome|Apremilast - Fed|Participants received a single 30 mg apremilast tablet administered after a high fat meal.
11108425|NCT01634178|EG000|Reported Event|Apremilast - Fasted|Participants received a single 30 mg apremilast tablet administered under fasted conditions.
11108426|NCT01634178|EG001|Reported Event|Apremilast - Fed|Participants received a single 30 mg apremilast tablet administered after a high fat meal.
11108427|NCT01634178|EG002|Reported Event|Total|Participants received one dose of 30 mg apremilast administered under fasted conditions and one dose of 30 mg apremilast after a full fat meal.
11108428|NCT01634191|BG000|Baseline|Young Males|Men aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
11108429|NCT01634191|BG001|Baseline|Young Females|Women aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
10846826|NCT00280150|OG000|Outcome|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy
11108430|NCT01634191|BG002|Baseline|Elderly Males|Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108431|NCT01634191|BG003|Baseline|Elderly Females|Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108432|NCT01634191|BG004|Baseline|Total|Total of all reporting groups
11108433|NCT01634191|FG000|Participant Flow|Young: Apremilast 30 mg|Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
11108434|NCT01634191|FG001|Participant Flow|Elderly: Apremilast 30 mg|Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108435|NCT01634191|OG000|Outcome|Young: Apremilast|Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
11108436|NCT01634191|OG001|Outcome|Elderly: Apremilast|Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108437|NCT01634191|OG000|Outcome|Young Males|Men aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
11108438|NCT01634191|OG001|Outcome|Young Females|Women aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
11108439|NCT01634191|OG002|Outcome|Elderly Males|Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108440|NCT01634191|OG003|Outcome|Elderly Females|Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108441|NCT01634191|OG000|Outcome|Males (Combined)|Male participants received a single oral dose of 30 mg apremilast on Day 1.
11108442|NCT01634191|OG001|Outcome|Females (Combined)|Female participants received a single oral dose of 30 mg apremilast on Day 1.
11108443|NCT01634191|EG000|Reported Event|Young Males|Men aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
11108444|NCT01634191|EG001|Reported Event|Young Females|Women aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
11108445|NCT01634191|EG002|Reported Event|Young (Total)|Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
11108446|NCT01634191|EG003|Reported Event|Elderly Males|Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108447|NCT01634191|EG004|Reported Event|Elderly Females|Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108448|NCT01634191|EG005|Reported Event|Elderly (Total)|Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
11108449|NCT01634191|EG006|Reported Event|Overall Total|All study participants received a single oral dose of 30 mg apremilast on Day 1.
11108450|NCT01634243|BG000|Baseline|Early-stage Parkinson's Disease|
11108451|NCT01634243|BG001|Baseline|Advanced Parkinson's Disease|
11108452|NCT01634243|BG002|Baseline|Total|Total of all reporting groups
11108453|NCT01634243|FG000|Participant Flow|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
11108454|NCT01634243|FG001|Participant Flow|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
11108455|NCT01634243|OG000|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
11108456|NCT01634243|OG001|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
11108457|NCT01634243|EG000|Reported Event|Early-stage Parkinson's Disease|
11108458|NCT01634243|EG001|Reported Event|Advanced Parkinson's Disease|
11108459|NCT01634256|BG000|Baseline|Fermented Curcuma|
11108460|NCT01634256|BG001|Baseline|Placebo|
11108461|NCT01634256|BG002|Baseline|Total|Total of all reporting groups
11108462|NCT01634256|FG000|Participant Flow|Fermented Turmeric|"Fermented turmeric(3times/day, 6capsules/day, 3g/day) for 12weeks~Fermented curcuma : Powdered Curcuma longa L., was produced through the fermentation of Aspergillus oryzae to 25 ˚ C for 36 hours."
11108463|NCT01634256|FG001|Participant Flow|Placebo|"Placebo(3times/day, 6capsules/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Fermented turmeric."
11108464|NCT01634256|OG000|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
10846827|NCT00280150|OG001|Outcome|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
11108465|NCT01634256|OG001|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
11108466|NCT01634256|EG000|Reported Event|Fermented Curcuma|Oral intake fermented curcuma (3.0g/day) for 12weeks.
11108467|NCT01634256|EG001|Reported Event|Placebo|Oral intake placebo(3.0g/day) for 12weeks
11108468|NCT01634269|BG000|Baseline|MDT-2111 TAVI 23 mm|Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
11108469|NCT01634269|FG000|Participant Flow|MDT-2111 TAVI 23 mm|Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
11108470|NCT01634269|OG000|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.
11108471|NCT01634269|OG001|Outcome|Iliofemoral Implanted Subjects|The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
11108472|NCT01634269|OG000|Outcome|As Treated Subjects|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
11108473|NCT01634269|OG000|Outcome|As Treated (AT) Subjects With Index Procedure|The (AT) population with Index Procedure was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo placed, or monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
11108474|NCT01634269|OG000|Outcome|As Treated Subjects With Index Procedure|The (AT) population with Index Procedure was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo placed, or monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
11108475|NCT01634269|EG000|Reported Event|Iliofemoral (As Treated Subjects)|The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients implanted with Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
11108476|NCT01634269|EG001|Reported Event|Direct Aortic (As Treated Subjects)|For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in overseas (EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
11108477|NCT01634269|EG002|Reported Event|All Subjects (As Treated Subjects)|This includes subjects from all access approaches, iliofemoral and direct aortic who were implanted with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
11108478|NCT01634360|BG000|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
11108479|NCT01634360|BG001|Baseline|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
11108480|NCT01634360|BG002|Baseline|Total|Total of all reporting groups
11108481|NCT01634360|FG000|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
11108482|NCT01634360|FG001|Participant Flow|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
11108483|NCT01634360|OG000|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
11108484|NCT01634360|OG001|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
11108485|NCT01634360|EG000|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
11108486|NCT01634360|EG001|Reported Event|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
11108487|NCT01634555|BG000|Baseline|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
11108488|NCT01634555|FG000|Participant Flow|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 milligrams per square meter (mg/m²) administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each 2-week cycle"
11108489|NCT01634555|OG000|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
11108490|NCT01634555|OG000|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
11108491|NCT01634555|EG000|Reported Event|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 mg/kg, administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
11108492|NCT01634620|BG000|Baseline|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
11108493|NCT01634620|FG000|Participant Flow|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
11108494|NCT01634620|OG000|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
11108495|NCT01634620|OG000|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
11108496|NCT01634620|OG000|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
11108497|NCT01634620|OG001|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
11108498|NCT01634620|OG002|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
11108499|NCT01634620|OG002|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
11108500|NCT01634620|EG000|Reported Event|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
11108501|NCT01634659|BG000|Baseline|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
11108502|NCT01634659|BG001|Baseline|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
11108503|NCT01634659|BG002|Baseline|Total|Total of all reporting groups
11108504|NCT01634659|FG000|Participant Flow|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
11108505|NCT01634659|FG001|Participant Flow|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
11108506|NCT01634659|OG000|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
11108507|NCT01634659|OG001|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
11108508|NCT01634659|EG000|Reported Event|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
11108509|NCT01634659|EG001|Reported Event|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
11108510|NCT01634854|BG000|Baseline|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
11108511|NCT01634854|BG001|Baseline|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
11108512|NCT01634854|BG002|Baseline|Total|Total of all reporting groups
11108513|NCT01634854|FG000|Participant Flow|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
11108514|NCT01634854|FG001|Participant Flow|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
11108515|NCT01634854|OG000|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
11108516|NCT01634854|OG001|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
11108517|NCT01634854|EG000|Reported Event|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
11108518|NCT01634854|EG001|Reported Event|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
11108519|NCT01635062|BG000|Baseline|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
10846828|NCT00280150|OG002|Outcome|Cohort 3|Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
10846829|NCT00280150|OG003|Outcome|Phase II|Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
11108520|NCT01635062|BG001|Baseline|Placebo|"Subjects will receive placebo for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
11108521|NCT01635062|BG002|Baseline|Total|Total of all reporting groups
11108522|NCT01635062|FG000|Participant Flow|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
11108523|NCT01635062|FG001|Participant Flow|Placebo|"Subjects will receive placebo for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
11108524|NCT01635062|OG000|Outcome|Calcitriol|Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
11108525|NCT01635062|OG001|Outcome|Placebo|Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
11108526|NCT01635062|OG000|Outcome|Calcitriol|Subjects have their renal plasma flow assessed at baseline while sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat renal plasma flow assessments again while sodium loaded.
11108527|NCT01635062|OG001|Outcome|Placebo|Subjects have their renal plasma flow assessed at baseline while sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat renal plasma flow assessments again while sodium loaded.
11108528|NCT01635062|OG000|Outcome|Calcitriol|Subjects have their urine protein assessed at baseline while sodium sodium loaded and again following 3 weeks of randomization to calcitriol (up to 0.75 mcg daily) or placebo.
11108529|NCT01635062|OG001|Outcome|Placebo|Subjects have their urine protein assessed at baseline while sodium sodium loaded and again following 3 weeks of randomization to calcitriol (up to 0.75 mcg daily) or placebo.
11108530|NCT01635062|EG000|Reported Event|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Calcitriol: Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks."
11108531|NCT01635062|EG001|Reported Event|Placebo|"Subjects will receive placebo for 3 weeks.~Placebo: Subjects will receive placebo for 3 weeks."
11108532|NCT01635101|BG000|Baseline|Low Dose Acetaminophen|Participants received a low dose of acetaminophen for 24 hours
10846830|NCT00280150|OG000|Outcome|Induction Therapy|Percentage of all patients receiving induction therapy
10846831|NCT00280150|OG001|Outcome|Concurrent Therapy|Percentage of all patients receiving concurrent therapy
11108533|NCT01635101|BG001|Baseline|High Dose Acetaminophen|Participants receive a high dose of acetaminophen for 24 hours
11108534|NCT01635101|BG002|Baseline|Placebo|Participants receive matching placebo for 24 hours
11108535|NCT01635101|BG003|Baseline|Total|Total of all reporting groups
11108536|NCT01635101|FG000|Participant Flow|Low Dose Acetaminophen|Participants receive a low dose of acetaminophen for 24 hours
11108537|NCT01635101|FG001|Participant Flow|High Dose Acetaminophen|Participants receive a high dose of acetaminophen for 24 hours
11108538|NCT01635101|FG002|Participant Flow|Placebo|Participants receive matching placebo administered intravenously for 24 hours
11108539|NCT01635101|OG000|Outcome|Low Dose Acetaminophen|Participants receive a low dose of acetaminophen for 24 hours
11108540|NCT01635101|OG001|Outcome|High Dose Acetaminophen|Participants receive a high dose of acetaminophen for 24 hours
11108541|NCT01635101|OG002|Outcome|Placebo|Participants receive matching placebo for 24 hours
11108542|NCT01635101|OG000|Outcome|Low Dose Acetaminophen|Participants receive low dose acetaminophen for 24 hours
11108543|NCT01635101|OG001|Outcome|High Dose Acetaminophen|Participants receive high dose acetaminophen for 24 hours
11108544|NCT01635101|OG002|Outcome|Placebo|Participants receive placebo for 24 hours
11108545|NCT01635101|EG000|Reported Event|Low Dose Acetaminophen|Participants receive a low dose of acetaminophen for 24 hours
11108546|NCT01635101|EG001|Reported Event|High Dose Acetaminophen|Participants receive a high dose of acetaminophen for 24 hours
11108547|NCT01635101|EG002|Reported Event|Placebo|Participants receive matching placebo for 24 hours
11108548|NCT01635153|BG000|Baseline|Protein Calorie Supplement Plus Micronutrient|Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein
11108549|NCT01635153|BG001|Baseline|Micronutrient Alone|Micronutrient: Dar-vite Multivitamin
11108550|NCT01635153|BG002|Baseline|Total|Total of all reporting groups
11108551|NCT01635153|FG000|Participant Flow|Protein Calorie Supplement Plus Micronutrient|Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein
11108552|NCT01635153|FG001|Participant Flow|Micronutrient Alone|Micronutrient: Dar-vite Multivitamin
11108553|NCT01635153|OG000|Outcome|Protein Calorie Supplement Plus Micronutrient|Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein
11108554|NCT01635153|OG001|Outcome|Micronutrient Alone|Micronutrient: Dar-vite Multivitamin
11108555|NCT01635153|EG000|Reported Event|Protein Calorie Supplement Plus Micronutrient|Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein
11108556|NCT01635153|EG001|Reported Event|Micronutrient Alone|Micronutrient: Dar-vite Multivitamin
11108557|NCT01635218|BG000|Baseline|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
11108558|NCT01635218|BG001|Baseline|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
11108559|NCT01635218|BG002|Baseline|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
11108560|NCT01635218|BG003|Baseline|Total|Total of all reporting groups
11108561|NCT01635218|FG000|Participant Flow|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
11108562|NCT01635218|FG001|Participant Flow|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
11108563|NCT01635218|FG002|Participant Flow|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
11108564|NCT01635218|OG000|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
11108565|NCT01635218|OG001|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
11108566|NCT01635218|OG002|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
11108567|NCT01635218|EG000|Reported Event|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
11108568|NCT01635218|EG001|Reported Event|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded could be repeated at week 4."
11108569|NCT01635218|EG002|Reported Event|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
11108570|NCT01635244|BG000|Baseline|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108571|NCT01635244|BG001|Baseline|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108572|NCT01635244|BG002|Baseline|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108573|NCT01635244|BG003|Baseline|Total|Total of all reporting groups
11108574|NCT01635244|FG000|Participant Flow|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108575|NCT01635244|FG001|Participant Flow|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108576|NCT01635244|FG002|Participant Flow|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
10846832|NCT00280150|OG000|Outcome|Overall Study|This includes patients from all cohorts.
10846833|NCT00280150|OG000|Outcome|Overall Study|All 45 patients were included in the summary of efficacy outcomes.
11108577|NCT01635244|OG000|Outcome|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108578|NCT01635244|OG001|Outcome|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108579|NCT01635244|OG002|Outcome|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108580|NCT01635244|EG000|Reported Event|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108581|NCT01635244|EG001|Reported Event|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108582|NCT01635244|EG002|Reported Event|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
11108583|NCT01635283|BG000|Baseline|Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)|"Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.~tumor lysate-pulsed autologous dendritic cell vaccine: Given ID~laboratory biomarker analysis: Correlative studies"
11108584|NCT01635283|FG000|Participant Flow|Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)|"Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.~tumor lysate-pulsed autologous dendritic cell vaccine: Given ID~laboratory biomarker analysis: Correlative studies"
11108585|NCT01635283|OG000|Outcome|Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)|"Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.~tumor lysate-pulsed autologous dendritic cell vaccine: Given ID~laboratory biomarker analysis: Correlative studies"
11108586|NCT01635283|OG000|Outcome|%CD8+/Field|
11108587|NCT01635283|OG001|Outcome|%PD-1+/Field|
11108588|NCT01635283|OG002|Outcome|%PD-L1+/Field|
11108589|NCT01635283|EG000|Reported Event|Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)|"Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.~tumor lysate-pulsed autologous dendritic cell vaccine: Given ID~laboratory biomarker analysis: Correlative studies"
11108590|NCT01635439|BG000|Baseline|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
11108591|NCT01635439|BG001|Baseline|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
11108592|NCT01635439|BG002|Baseline|Total|Total of all reporting groups
11108593|NCT01635439|FG000|Participant Flow|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
11108594|NCT01635439|FG001|Participant Flow|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
11108595|NCT01635439|OG000|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
11108596|NCT01635439|OG001|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
11108597|NCT01635439|EG000|Reported Event|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
11108598|NCT01635439|EG001|Reported Event|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
11108599|NCT01635504|BG000|Baseline|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
11108600|NCT01635504|FG000|Participant Flow|Botulinum Toxin A|Botulinum toxin A 50 units per side of the posterior cheek enlargement, injected into the masseter muscle and parotid gland (10 units into 5 points of the posterior cheek enlargement per side, giving a total of 100 units per patient)
11108601|NCT01635504|OG000|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
11108602|NCT01635504|EG000|Reported Event|HIV Posterior Cheek Enlargement Group|Injected with botulinum toxin A
11108603|NCT01635764|BG000|Baseline|EW/EW/EW|All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
11108604|NCT01635764|BG001|Baseline|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
11108605|NCT01635764|BG002|Baseline|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
11108606|NCT01635764|BG003|Baseline|PBO/EW/EW|All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
11108607|NCT01635764|BG004|Baseline|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
11108608|NCT01635764|BG005|Baseline|Total|Total of all reporting groups
11108609|NCT01635764|FG000|Participant Flow|Adalimumab Every Week|Adalimumab 40 mg every week.
11108610|NCT01635764|OG000|Outcome|EW/EW/EW|All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
11108611|NCT01635764|OG001|Outcome|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
11108612|NCT01635764|OG002|Outcome|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
11108613|NCT01635764|OG000|Outcome|PBO/EW/EW|All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
11108614|NCT01635764|OG000|Outcome|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
11108615|NCT01635764|OG000|Outcome|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
11108616|NCT01635764|OG001|Outcome|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
11108617|NCT01635764|OG002|Outcome|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
11108618|NCT01635764|EG000|Reported Event|All Adalimumab|Participants who received at least 1 dose of adalimumab (40 mg every week) in M12-555.
11108619|NCT01635855|BG000|Baseline|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
11108620|NCT01635855|FG000|Participant Flow|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
11108621|NCT01635855|OG000|Outcome|Belotero|Belotero®: Hyaluronic acid dermal filler
11108622|NCT01635855|EG000|Reported Event|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
11108623|NCT01635881|BG000|Baseline|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
11108624|NCT01635881|FG000|Participant Flow|Emerge|Single arm with investigational Emerge™ 1.20 mm percutaneous transluminal coronary angioplasty (PTCA) Dilatation Catheter
11108625|NCT01635881|OG000|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
11108626|NCT01635881|EG000|Reported Event|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
11108627|NCT01635920|BG000|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
11108628|NCT01635920|BG001|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
11108629|NCT01635920|BG002|Baseline|Total|Total of all reporting groups
11108630|NCT01635920|FG000|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
11108631|NCT01635920|FG001|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
11108632|NCT01635920|OG000|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
11108633|NCT01635920|OG001|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
11108634|NCT01635920|OG000|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with print worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
11108635|NCT01635920|EG000|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
10846834|NCT00280150|EG000|Reported Event|Overall Study|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. This includes patients from all cohorts.
11108636|NCT01635920|EG001|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
11108637|NCT01635933|BG000|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11108638|NCT01635933|BG001|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11108639|NCT01635933|BG002|Baseline|Total|Total of all reporting groups
11108640|NCT01635933|FG000|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11108641|NCT01635933|FG001|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11108642|NCT01635933|OG000|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11108643|NCT01635933|OG001|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11108644|NCT01635933|EG000|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11108645|NCT01635933|EG001|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11108646|NCT01635998|BG000|Baseline|Renal Sympathetic Denervation PLUS Catheter Ablation|"Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.~Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation."
11108647|NCT01635998|BG001|Baseline|Routine Catheter Abation|Routine catheter ablation of atrial fibrillation only.
11108648|NCT01635998|BG002|Baseline|Total|Total of all reporting groups
11108649|NCT01635998|FG000|Participant Flow|Renal Sympathetic Denervation PLUS Catheter Ablation|"Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.~Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation."
11108650|NCT01635998|FG001|Participant Flow|Routine Catheter Abation|Routine catheter ablation of atrial fibrillation only.
11108651|NCT01635998|OG000|Outcome|Renal Sympathetic Denervation PLUS Catheter Ablation|"Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.~Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation."
11108652|NCT01635998|OG001|Outcome|Routine Catheter Abation|Routine catheter ablation of atrial fibrillation only.
11108653|NCT01635998|EG000|Reported Event|Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti|"Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.~Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation."
11108654|NCT01635998|EG001|Reported Event|Routine Catheter Abation|Routine catheter ablation of atrial fibrillation only.
11108655|NCT01636063|BG000|Baseline|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
11108656|NCT01636063|BG001|Baseline|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
11108657|NCT01636063|BG002|Baseline|Total|Total of all reporting groups
11108658|NCT01636063|FG000|Participant Flow|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
11108659|NCT01636063|FG001|Participant Flow|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
11108660|NCT01636063|OG000|Outcome|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
11108661|NCT01636063|OG001|Outcome|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
11108662|NCT01636063|EG000|Reported Event|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
11108663|NCT01636063|EG001|Reported Event|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
11108664|NCT01636076|BG000|Baseline|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
11108665|NCT01636076|BG001|Baseline|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
11108666|NCT01636076|BG002|Baseline|Total|Total of all reporting groups
11108667|NCT01636076|FG000|Participant Flow|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
11108668|NCT01636076|FG001|Participant Flow|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
11108669|NCT01636076|OG000|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
11108670|NCT01636076|OG001|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
11108671|NCT01636076|OG000|Outcome|QMF149 (Analyte Mometasone Furoate)|Assay Analyte: MOMETASONE FUROATE, component of QMF 149 mixture
11108672|NCT01636076|OG001|Outcome|QMF149 (Analyte Indacaterol Acetate)|Assay Analyte: QAB149 (Indacaterol acetate), component of QMF 149 mixture
11108673|NCT01636076|OG000|Outcome|QMF149 Analyte: Mometasone Furoate|Mometasone furoate as part of QMF149F
11108674|NCT01636076|OG001|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
11108675|NCT01636076|OG000|Outcome|QMF 149 Anaylyte: Mometasone Furorate|Mometasone furoate as a component of QMF149F
11108676|NCT01636076|OG000|Outcome|QMF149 Analyte Mometasone Furoate|QMF149 Mometasone furoate analyte from mixture
11108677|NCT01636076|OG001|Outcome|QMF149 Analyte QAB149|QMF149 analyte QAB149 ( indacaterol acetate)
11108678|NCT01636076|EG000|Reported Event|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
11108679|NCT01636076|EG001|Reported Event|SALM/FLUT|SALM/FLUT
11108680|NCT01636102|BG000|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
11108681|NCT01636102|BG001|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
11108682|NCT01636102|BG002|Baseline|Total|Total of all reporting groups
11108683|NCT01636102|FG000|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
11108684|NCT01636102|FG001|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
11108685|NCT01636102|OG000|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
11108686|NCT01636102|OG001|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
11108687|NCT01636102|OG000|Outcome|18 - 60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
11108688|NCT01636102|EG000|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
11108689|NCT01636102|EG001|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
11108690|NCT01636206|BG000|Baseline|Placebo|
11108691|NCT01636206|BG001|Baseline|Lifitegrast|
11108692|NCT01636206|BG002|Baseline|Total|Total of all reporting groups
11108693|NCT01636206|FG000|Participant Flow|Placebo|
11108694|NCT01636206|FG001|Participant Flow|Lifitegrast|
11108695|NCT01636206|OG000|Outcome|Placebo|
11108696|NCT01636206|OG001|Outcome|Lifitegrast|
11108697|NCT01636206|EG000|Reported Event|Placebo|
11108698|NCT01636206|EG001|Reported Event|Lifitegrast|
11108699|NCT01636284|BG000|Baseline|JX-594 Recombinant Vaccina GM-CSF|"JX-594 recombinant vaccina GM-CSF~JX-594 recombinant vaccina GM-CSF: Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal."
11108700|NCT01636284|FG000|Participant Flow|JX-594 Recombinant Vaccina GM-CSF|"JX-594 recombinant vaccina GM-CSF~JX-594 recombinant vaccina GM-CSF: Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal."
11108701|NCT01636284|OG000|Outcome|JX-594 Recombinant Vaccina GM-CSF|"JX-594 recombinant vaccina GM-CSF~JX-594 recombinant vaccina GM-CSF: Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal."
11108702|NCT01636284|EG000|Reported Event|JX-594 Recombinant Vaccina GM-CSF|"JX-594 recombinant vaccina GM-CSF~JX-594 recombinant vaccina GM-CSF: Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal."
11108703|NCT01636297|BG000|Baseline|Forced Exercise|Forced exercise: Exercise on a stationary bicycle, driven by a motor controlled by an algorithm, to force an individual to pedal faster than their voluntary cadence, 3 times per week for 8 weeks
11108704|NCT01636297|BG001|Baseline|Voluntary Exercise|Voluntary exercise: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks
11108705|NCT01636297|BG002|Baseline|No Exercise|No-exercise/control: No exercise intervention is given. This group serves as a control group.
11108706|NCT01636297|BG003|Baseline|Total|Total of all reporting groups
11108707|NCT01636297|FG000|Participant Flow|Forced Exercise|Forced exercise: Exercise on a stationary cycle, controlled by motor , to augment voluntary rate by 35%
11108708|NCT01636297|FG001|Participant Flow|Voluntary Exercise|Voluntary exercise: Exercise on a stationary bicycle without motor assistance
11108709|NCT01636297|FG002|Participant Flow|No Exercise|No-exercise/control: No exercise intervention is given. This group serves as a control group.
11108710|NCT01636297|OG000|Outcome|Forced Exercise|Forced exercise: Exercise on a stationary bicycle, driven by a motor controlled by an algorithm, to force an individual to pedal faster than their voluntary cadence, 3 times per week for 8 weeks
11108711|NCT01636297|OG001|Outcome|Voluntary Exercise|Voluntary exercise: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks
11108712|NCT01636297|OG002|Outcome|No Exercise|No-exercise/control: No exercise intervention is given. This group serves as a control group.
11108713|NCT01636297|OG000|Outcome|Forced Exercise|Forced exercise: Exercise on a stationary cycle, controlled by a motor to augment voluntary rate by 35%
11108714|NCT01636297|OG001|Outcome|Voluntary Exercise|Voluntary exercise: Exercise on a stationary cycle without motor assistance
11108715|NCT01636297|EG000|Reported Event|Forced Exercise|Forced exercise: Exercise on a stationary cycle that was controlled by a motor to augment voluntary rate by 35%
11108716|NCT01636297|EG001|Reported Event|Voluntary Exercise|Voluntary exercise: Exercise on a stationary cycle without motor assistance
11108717|NCT01636297|EG002|Reported Event|No Exercise|No-exercise/control: No exercise intervention is given. This group serves as a control group.
11108718|NCT01636362|BG000|Baseline|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
11108719|NCT01636362|FG000|Participant Flow|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
11108720|NCT01636362|OG000|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
11108721|NCT01636362|EG000|Reported Event|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
11108722|NCT01636414|BG000|Baseline|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
11108723|NCT01636414|BG001|Baseline|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
11108724|NCT01636414|BG002|Baseline|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
11108725|NCT01636414|BG003|Baseline|Total|Total of all reporting groups
11108726|NCT01636414|FG000|Participant Flow|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
11108727|NCT01636414|FG001|Participant Flow|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
11108728|NCT01636414|FG002|Participant Flow|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
11108729|NCT01636414|OG000|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
11108730|NCT01636414|OG001|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
11108731|NCT01636414|OG002|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
11108732|NCT01636414|EG000|Reported Event|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
11108733|NCT01636414|EG001|Reported Event|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
11108734|NCT01636414|EG002|Reported Event|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
11108735|NCT01636453|BG000|Baseline|Liberty Stent Arm|"Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months~Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months"
11108736|NCT01636453|FG000|Participant Flow|Liberty Stent Arm|"Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months~Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months"
11108737|NCT01636453|OG000|Outcome|Liberty Stent Arm|"Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months~Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months"
11108738|NCT01636453|EG000|Reported Event|Liberty Stent Arm|"Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months~Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months"
11108739|NCT01636661|BG000|Baseline|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
11108740|NCT01636661|BG001|Baseline|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
11108741|NCT01636661|BG002|Baseline|Total|Total of all reporting groups
11108742|NCT01636661|FG000|Participant Flow|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
11108743|NCT01636661|FG001|Participant Flow|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
11108744|NCT01636661|OG000|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
11108745|NCT01636661|OG001|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
11108746|NCT01636661|EG000|Reported Event|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
11108747|NCT01636661|EG001|Reported Event|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
11108748|NCT01636687|BG000|Baseline|AIN457 150 mg|Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
11108749|NCT01636687|BG001|Baseline|AIN457 300 mg|Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
11108750|NCT01636687|BG002|Baseline|Placebo|placebo secukinumab (2 s.c. injections) at each dosing
11108751|NCT01636687|BG003|Baseline|Total|Total of all reporting groups
11108752|NCT01636687|FG000|Participant Flow|AIN457 150 mg|Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
11108753|NCT01636687|FG001|Participant Flow|AIN457 300 mg|Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
11108754|NCT01636687|FG002|Participant Flow|Placebo - AIN457 150 mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
11108755|NCT01636687|FG003|Participant Flow|Placebo - AIN457 300mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
11108756|NCT01636687|FG004|Participant Flow|Placebo|placebo secukinumab (2 s.c. injections) at each dosing
11108757|NCT01636687|OG000|Outcome|AIN457 150 mg|Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
11108758|NCT01636687|OG001|Outcome|AIN457 300 mg|Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
11108759|NCT01636687|OG002|Outcome|Placebo|placebo secukinumab (2 s.c. injections) at each dosing
11108760|NCT01636687|OG002|Outcome|Placebo - AIN457 150 mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
11108761|NCT01636687|OG003|Outcome|Placebo - AIN457 300 mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
11108762|NCT01636687|OG004|Outcome|Placebo|placebo secukinumab (2 s.c. injections) at each dosing
11108763|NCT01636687|OG003|Outcome|Placebo - AIN457 300mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
11108764|NCT01636687|OG002|Outcome|Placebo-AIN457 150 mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
11108765|NCT01636687|OG003|Outcome|Placebo - AIN457 300mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
11108766|NCT01636687|OG004|Outcome|Placebo|Placebo secukinumab (2 s.c. injections) at each dosing
11108767|NCT01636687|EG000|Reported Event|Induction AIN457 150 mg|Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
11108768|NCT01636687|EG001|Reported Event|Induction AIN457 300 mg|Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
11108769|NCT01636687|EG002|Reported Event|Induction Placebo|placebo secukinumab (2 s.c. injections) at each dosing
11108770|NCT01636687|EG003|Reported Event|Entire Any AIN457 150 mg|Includes all patients in the AIN457 150 mg and in the placebo- AIN457 150 mg treatment groups.
11108771|NCT01636687|EG004|Reported Event|Entire Any AIN457 300 mg|Includes all patients in the AIN457 300 mg and in the placebo- AIN457 300 mg treatment groups.
11108772|NCT01636687|EG005|Reported Event|Entire Placebo|placebo secukinumab (2 s.c. injections) at each dosing
11108773|NCT01636713|BG000|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
11108774|NCT01636713|BG001|Baseline|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
11108775|NCT01636713|BG002|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
11108776|NCT01636713|BG003|Baseline|Total|Total of all reporting groups
11108777|NCT01636713|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
11108778|NCT01636713|FG001|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
11108779|NCT01636713|FG002|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
11108780|NCT01636713|OG000|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
11108781|NCT01636713|OG001|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
11108782|NCT01636713|OG002|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
11108783|NCT01636713|EG000|Reported Event|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
11108784|NCT01636713|EG001|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
11108785|NCT01636713|EG002|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
11108786|NCT01636765|BG000|Baseline|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
11108787|NCT01636765|FG000|Participant Flow|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
11108788|NCT01636765|OG000|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
11108789|NCT01636765|EG000|Reported Event|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
11108790|NCT01636778|BG000|Baseline|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
11108791|NCT01636778|FG000|Participant Flow|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
11108792|NCT01636778|FG001|Participant Flow|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
11108793|NCT01636778|FG002|Participant Flow|Eltrombopag + Antiviral Therapy: Follow-up Period After Part|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
11108794|NCT01636778|OG000|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
11108795|NCT01636778|OG000|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
11108796|NCT01636778|OG000|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
11108797|NCT01636778|EG000|Reported Event|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of &lt;80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained &lt;100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
11108798|NCT01636778|EG001|Reported Event|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
11108799|NCT01636778|EG002|Reported Event|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
11108800|NCT01636882|BG000|Baseline|CVA21|Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals CVA21
11108801|NCT01636882|FG000|Participant Flow|CVA21|Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
11108802|NCT01636882|OG000|Outcome|CVA21|Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
11108803|NCT01636882|EG000|Reported Event|CVA21|Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
11108804|NCT01636934|BG000|Baseline|Minocycline|Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.
11108805|NCT01636934|BG001|Baseline|Placebo|Placebo 100 mg twice a day during during standard of care chemoradiation plus additional follow up for 5 weeks, for a total of 12 weeks.
11108806|NCT01636934|BG002|Baseline|Total|Total of all reporting groups
11108807|NCT01636934|FG000|Participant Flow|Minocycline|Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.
11108808|NCT01636934|FG001|Participant Flow|Placebo|Placebo 100 mg twice a day during during standard of care chemoradiation plus additional follow up for 5 weeks, for a total of 12 weeks.
11108809|NCT01636934|OG000|Outcome|Minocycline|Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.
11108810|NCT01636934|OG001|Outcome|Placebo|Placebo 100 mg twice a day during during standard of care chemoradiation plus additional follow up for 5 weeks, for a total of 12 weeks.
11108811|NCT01636934|EG000|Reported Event|Minocycline|Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.
11108812|NCT01636934|EG001|Reported Event|Placebo|Placebo 100 mg twice a day during during standard of care chemoradiation plus additional follow up for 5 weeks, for a total of 12 weeks.
11108813|NCT01636947|BG000|Baseline|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
11108814|NCT01636947|BG001|Baseline|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
11108815|NCT01636947|BG002|Baseline|Total|Total of all reporting groups
11108816|NCT01636947|FG000|Participant Flow|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
11108817|NCT01636947|FG001|Participant Flow|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
11108818|NCT01636947|OG000|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
11108819|NCT01636947|OG001|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
11108820|NCT01636947|EG000|Reported Event|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
11108821|NCT01636947|EG001|Reported Event|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
11108822|NCT01636960|BG000|Baseline|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
11108823|NCT01636960|FG000|Participant Flow|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
11108824|NCT01636960|OG000|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
11108825|NCT01636960|EG000|Reported Event|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
11108826|NCT01636986|BG000|Baseline|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
11108827|NCT01636986|BG001|Baseline|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
11108828|NCT01636986|BG002|Baseline|Total|Total of all reporting groups
11108829|NCT01636986|FG000|Participant Flow|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
11108830|NCT01636986|FG001|Participant Flow|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
11108831|NCT01636986|OG000|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
11108832|NCT01636986|OG001|Outcome|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
11108833|NCT01636986|EG000|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
11108834|NCT01636986|EG001|Reported Event|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
11126634|NCT01734551|EG000|Reported Event|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
11126635|NCT01734551|EG001|Reported Event|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
11126636|NCT01734655|BG000|Baseline|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
11126637|NCT01734655|FG000|Participant Flow|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices in either a focus group format (the first 11 participants) or cognitive interview format (the last 29 participants).
11126638|NCT01734655|OG000|Outcome|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
11126639|NCT01734655|OG000|Outcome|All Participants|All Participants
11126640|NCT01734655|OG000|Outcome|All Participants|all participants
11108835|NCT01637077|BG000|Baseline|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
11108836|NCT01637077|BG001|Baseline|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
11108837|NCT01637077|BG002|Baseline|Total|Total of all reporting groups
11108838|NCT01637077|FG000|Participant Flow|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
11108839|NCT01637077|FG001|Participant Flow|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
11108840|NCT01637077|OG000|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
11108841|NCT01637077|OG001|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
11108842|NCT01637077|EG000|Reported Event|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
11108843|NCT01637077|EG001|Reported Event|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
11108844|NCT01637090|BG000|Baseline|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
11108845|NCT01637090|FG000|Participant Flow|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
11108846|NCT01637090|OG000|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
11108847|NCT01637090|EG000|Reported Event|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
11108848|NCT01637142|BG000|Baseline|Oral 80 mg LY2140023 on Two Separate Occasions|"Participants received a single oral dose of 80 mg LY2140023 (parent compound) on 2 separate occasions.~In Treatment Period 1, a single oral dose of 80 mg LY2140023 followed by a single 2-hour IV infusion of approximately 100 µg LY2140023 containing approximately 100 nCi [14C]-LY2140023.~In Treatment Period 2, a single oral dose of 80 mg LY2140023 followed by a single 2-hour IV infusion of approximately 100 µg LY404039 (active metabolite) containing approximately 100 nCi [14C]-LY404039.~There was a washout period of at least 3 days between Treatment Period 1 and Treatment Period 2."
11108849|NCT01637142|FG000|Participant Flow|Oral 80 mg LY2140023 on Two Separate Occasions|"Participants received a single oral dose of 80 milligrams (mg) LY2140023 (parent compound) on 2 separate occasions.~In Treatment Period 1, a single oral dose of 80 mg LY2140023 followed by a single 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nanocuries (nCi) [14C]-LY2140023.~In Treatment Period 2, a single oral dose of 80 mg LY2140023 followed by a single 2-hour IV infusion of approximately 100 µg LY404039 (active metabolite) containing approximately 100 nCi [14C]-LY404039.~There was a washout period of at least 3 days between Treatment Period 1 and Treatment Period 2."
11108850|NCT01637142|OG000|Outcome|Oral 80 mg LY2140023 and IV LY2140023/[14C]-LY2140023|In Treatment Period 1, a single oral dose of 80 mg LY2140023 followed by a single 2-hour IV infusion of approximately 100 µg LY2140023 containing approximately 100 nCi [14C]-LY2140023.
11108851|NCT01637142|OG000|Outcome|Oral 80 mg LY2140023 and IV LY404039/[14C]-LY404039|In Treatment Period 2, a single oral dose of 80 mg LY2140023 (parent compound) followed by a single 2-hour IV infusion of approximately 100 µg LY404039 (active metabolite) containing approximately 100 nCi [14C]-LY404039.
11108852|NCT01637142|EG000|Reported Event|Oral 80 mg LY2140023 and IV LY2140023/[14C]-LY2140023|Treatment Period 1: On Day 1, a single oral dose of 80 mg LY2140023 (parent compound) followed by a single 2-hour IV infusion of approximately 100 µg LY2140023 containing approximately 100 nCi [14C]-LY2140023.
11108853|NCT01637142|EG001|Reported Event|Oral 80 mg LY2140023 and IV LY404039/[14C]-LY404039|Treatment Period 2: On Day 1, a single oral dose of 80 mg LY2140023 (parent compound) followed by a single 2-hour IV infusion of approximately 100 µg LY404039 (active metabolite) containing approximately 100 nCi [14C]-LY404039.
11108854|NCT01637246|BG000|Baseline|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
11108855|NCT01637246|FG000|Participant Flow|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
11108856|NCT01637246|OG000|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
11108857|NCT01637246|EG000|Reported Event|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
11108858|NCT01637272|BG000|Baseline|SOM230|Subjects with dumping syndrome treated with pasireotide
11108859|NCT01637272|FG000|Participant Flow|SOM230|Subjects with dumping syndrome treated with pasireotide
11108860|NCT01637272|OG000|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
11108861|NCT01637272|OG000|Outcome|SOM230- 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M)followed by pasireotide LAR (3M) for a total of 6 months
11108862|NCT01637272|OG001|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
11108863|NCT01637272|OG001|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
11108864|NCT01637272|OG002|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
11108865|NCT01637272|OG002|Outcome|SOM230 - 8 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
11108866|NCT01637272|OG000|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
11108867|NCT01637272|OG001|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
11108868|NCT01637272|OG002|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
11108869|NCT01637272|OG003|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
11108870|NCT01637272|OG000|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
11108871|NCT01637272|OG001|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
11108872|NCT01637272|OG002|Outcome|SOM LAR 30mg|Subjects with dumping syndrome treated with pasireotide LAR 30mg
11108873|NCT01637272|OG003|Outcome|SOM LAR 40mg|Subjects with dumping syndrome treated with pasireotide LAR 40mg
11108874|NCT01637272|OG004|Outcome|SOM LAR 60mg|Subjects with dumping syndrome treated with pasireotide LAR 60mg
11108875|NCT01637272|EG000|Reported Event|s.c. Phase|s.c. phase was made up of subjects with dumping syndrome who entered the study and were treated with pasireotide s.c.
11108876|NCT01637272|EG001|Reported Event|LAR Phase|LAR phase was made up of subjects with dumping syndrome who completed the s.c. phase, entered the LAR phase and were treated with pasireotide LAR
11108877|NCT01637402|BG000|Baseline|All Patients Who Received Treatment|"Abiraterone Acetate: Standard dose: 1,000 mg, once daily, oral administration~Increased dose offered after week 12 evaluation to participants who progressed after decline on standard dose: 1,000 mg, twice daily, oral administration~Prednisone: 5 mg, twice daily, oral administration"
11108878|NCT01637402|FG000|Participant Flow|Standard Dose|Abiraterone 1000 mg once daily Prednisone 5 mg twice daily
11108879|NCT01637402|FG001|Participant Flow|Escalated Dose|Abiraterone 1000 mg twice daily Prednisone 5 mg twice daily
11108880|NCT01637402|OG000|Outcome|Dose Escalation|"Dose Escalation (until PSA decrease of at least 30% after 12 weeks):~Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily"
11108881|NCT01637402|OG000|Outcome|Dose Escalation (CTCAE Grade 1)|Worst grade adverse event with CTCAE Grade 1 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
11108882|NCT01637402|OG001|Outcome|Dose Escalation (CTCAE Grade 2)|Worst grade adverse event with CTCAE Grade 2 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
11108883|NCT01637402|OG002|Outcome|Dose Escalation (CTCAE Grade 3)|Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
11108884|NCT01637402|OG003|Outcome|Dose Escalation (CTCAE Grade 4)|Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
11108885|NCT01637402|OG000|Outcome|Dose Escalation|Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
11108886|NCT01637402|OG000|Outcome|Concentration at First Draw on Standard Dose Therapy (4 Weeks)|Plasma Abiraterone concentration at 4 weeks for patients on standard dose
11108887|NCT01637402|OG001|Outcome|Concentration at Time of Disease Progression on Standard Dose|Plasma Abiraterone concentration at time of disease progression on standard dose
11108888|NCT01637402|OG002|Outcome|Concentration at Time of Response to Increased-dose|Plasma Abiraterone concentration at the time of a response to increased-dose Abiraterone Acetate
11108889|NCT01637402|OG003|Outcome|Concentration at Time of Disease Progression on Increased Dose|Plasma Abiraterone concentration at the time of disease progression on increased-dose therapy.
11108890|NCT01637402|OG000|Outcome|Standard Dose|"Standard Dose until progression:~Abiraterone 1,000 mg, once daily, Prednisone 5 mg twice daily"
11108891|NCT01637402|OG001|Outcome|Dose Escalation|"Dose Escalation (until PSA decrease of at least 30% after 12 weeks):~Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily"
11108892|NCT01637402|OG000|Outcome|Testosterone in Primary Resistant (STD)|Testosterone levels in patients without > 30% PSA decline during standard dose therapy.
11108893|NCT01637402|OG001|Outcome|Testosterone in Responders (STD)|Testosterone levels in patients with > 30% PSA decline during standard dose therapy
11108894|NCT01637402|OG000|Outcome|DHEA in Primary Resistant (STD)|DHEA levels in patients without > 30% PSA decline during standard dose therapy.
11108895|NCT01637402|OG001|Outcome|DHEA in Responders (STD)|DHEA levels in patients with > 30% PSA decline during standard dose therapy.
11108896|NCT01637402|OG001|Outcome|Dose-Escalation|"Dose Escalation (until PSA decrease of at least 30% after 12 weeks):~Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily"
11108897|NCT01637402|OG000|Outcome|DHEA-S in Primary Resistant (STD)|DHEA-S levels in patients without > 30% PSA decline during standard dose therapy.
11108898|NCT01637402|OG001|Outcome|DHEA-S in Responders (STD)|DHEA-S levels in patients with > 30% PSA decline during standard dose therapy.
11108899|NCT01637402|OG000|Outcome|Androstenedione in Primary Resistant (STD)|Androstenedione levels in patients without > 30% PSA decline during standard dose therapy.
11108900|NCT01637402|OG001|Outcome|Androstenedione in Responders (STD)|Androstenedione levels in patients with > 30% PSA decline during standard dose therapy.
11108901|NCT01637402|EG000|Reported Event|Standard Dose Therapy|Abiraterone 1000 mg daily, Prednisone 5 mg twice daily
11108902|NCT01637402|EG001|Reported Event|Dose Escalation|"Dose Escalation (until PSA decrease of at least 30% after 12 weeks):~Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily"
11108903|NCT01637584|BG000|Baseline|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
11108904|NCT01637584|BG001|Baseline|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
11108905|NCT01637584|BG002|Baseline|Total|Total of all reporting groups
11108906|NCT01637584|FG000|Participant Flow|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
11108907|NCT01637584|FG001|Participant Flow|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
11108908|NCT01637584|OG000|Outcome|Prazosin -Placebo|Difference in relative brain glucose metabolism between states and pre-to-post treatment for participants randomized to prazosin after adjusting for non-significant changes in the placebo group.
11108909|NCT01637584|OG000|Outcome|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
11108910|NCT01637584|OG001|Outcome|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
11108911|NCT01637584|EG000|Reported Event|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
11108912|NCT01637584|EG001|Reported Event|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
11108913|NCT01637623|BG000|Baseline|Losartan|"Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic and blood pressure within range.~Losartan: Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic."
11108914|NCT01637623|BG001|Baseline|Allopurinol|"Allopurinol 300 mg daily for 6 weeks~Allopurinol: Allopurinol 300 mg daily for 6 weeks"
11108915|NCT01637623|BG002|Baseline|Placebo|"Placebo capsule daily for 6 weeks~Placebo: Placebo capsule daily for 6 weeks"
11108916|NCT01637623|BG003|Baseline|Total|Total of all reporting groups
11108917|NCT01637623|FG000|Participant Flow|Losartan|"Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic and blood pressure within range.~Losartan: Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic."
11108918|NCT01637623|FG001|Participant Flow|Allopurinol|"Allopurinol 300 mg daily for 6 weeks~Allopurinol: Allopurinol 300 mg daily for 6 weeks"
11108919|NCT01637623|FG002|Participant Flow|Placebo|"Placebo capsule daily for 6 weeks~Placebo: Placebo capsule daily for 6 weeks"
11108920|NCT01637623|OG000|Outcome|Losartan|"Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic and blood pressure within range.~Losartan: Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic."
11108921|NCT01637623|OG001|Outcome|Allopurinol|"Allopurinol 300 mg daily for 6 weeks~Allopurinol: Allopurinol 300 mg daily for 6 weeks"
11108922|NCT01637623|OG002|Outcome|Placebo|"Placebo capsule daily for 6 weeks~Placebo: Placebo capsule daily for 6 weeks"
11108923|NCT01637623|EG000|Reported Event|Losartan|"Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic and blood pressure within range.~Losartan: Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic."
11108924|NCT01637623|EG001|Reported Event|Allopurinol|"Allopurinol 300 mg daily for 6 weeks~Allopurinol: Allopurinol 300 mg daily for 6 weeks"
11108925|NCT01637623|EG002|Reported Event|Placebo|"Placebo capsule daily for 6 weeks~Placebo: Placebo capsule daily for 6 weeks"
11108926|NCT01637870|BG000|Baseline|Negative Pressure Pump|Will have the Prevena negative pressure wound system placed at the time of surgery.
11108927|NCT01637870|FG000|Participant Flow|Negative Pressure Pump|Will have the Prevena negative pressure wound system placed at the time of surgery.
11108928|NCT01637870|OG000|Outcome|Negative Pressure Pump|Will have the Prevena negative pressure wound system placed at the time of surgery.
11108929|NCT01637870|EG000|Reported Event|Negative Pressure Pump|"Will have the Prevena negative pressure wound system placed at the time of surgery.~Prevena negative pressure wound system: Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication"
11108930|NCT01637922|BG000|Baseline|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
11108931|NCT01637922|BG001|Baseline|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
11108932|NCT01637922|BG002|Baseline|Total|Total of all reporting groups
11108933|NCT01637922|FG000|Participant Flow|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
11108934|NCT01637922|FG001|Participant Flow|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
11108935|NCT01637922|OG000|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
11108936|NCT01637922|OG001|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
11108937|NCT01637922|OG000|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
11108938|NCT01637922|EG000|Reported Event|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
11108939|NCT01637922|EG001|Reported Event|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
11108940|NCT01637935|BG000|Baseline|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
11108941|NCT01637935|BG001|Baseline|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
11108942|NCT01637935|BG002|Baseline|Total|Total of all reporting groups
11108943|NCT01637935|FG000|Participant Flow|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
11108944|NCT01637935|FG001|Participant Flow|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
11108945|NCT01637935|OG000|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
11108946|NCT01637935|OG001|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
11108947|NCT01637935|EG000|Reported Event|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
11108948|NCT01637935|EG001|Reported Event|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
11108949|NCT01637961|BG000|Baseline|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
11108950|NCT01637961|FG000|Participant Flow|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
11108951|NCT01637961|OG000|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
11108952|NCT01637961|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
11108953|NCT01637961|OG001|Outcome|Grade 1 (CTCAE v 4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
11108954|NCT01637961|OG002|Outcome|Grade 2 (CTCAE v 4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
11108955|NCT01637961|OG003|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
11108956|NCT01637961|OG004|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
11108957|NCT01637961|OG005|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
11108958|NCT01637961|EG000|Reported Event|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
11108959|NCT01638000|BG000|Baseline|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
11108960|NCT01638000|BG001|Baseline|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
11108961|NCT01638000|BG002|Baseline|Total|Total of all reporting groups
11108962|NCT01638000|FG000|Participant Flow|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
11108963|NCT01638000|FG001|Participant Flow|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
11108964|NCT01638000|OG000|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
11108965|NCT01638000|OG001|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
11108966|NCT01638000|EG000|Reported Event|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
11108967|NCT01638000|EG001|Reported Event|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
11108968|NCT01638013|BG000|Baseline|Participants Who Completed 015K-CL-RAJ1|Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108969|NCT01638013|BG001|Baseline|Participants Who Completed 015K-CL-RAJ3|Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108970|NCT01638013|BG002|Baseline|Participants Who Completed 015K-CL-RAJ4|Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108971|NCT01638013|BG003|Baseline|Total|Total of all reporting groups
11108972|NCT01638013|FG000|Participant Flow|Participants Who Completed 015K-CL-RAJ1|Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108973|NCT01638013|FG001|Participant Flow|Participants Who Completed 015K-CL-RAJ3|Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108974|NCT01638013|FG002|Participant Flow|Participants Who Completed 015K-CL-RAJ4|Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108975|NCT01638013|OG000|Outcome|Participants Who Completed 015K-CL-RAJ1|Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108976|NCT01638013|OG001|Outcome|Participants Who Completed 015K-CL-RAJ3|Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108977|NCT01638013|OG002|Outcome|Participants Who Completed 015K-CL-RAJ4|Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11348284|NCT04189081|BG001|Baseline|Experimental Mouth Rinse|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11108978|NCT01638013|OG000|Outcome|Participants Who Completed 015K-CL-RAJ1|Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108979|NCT01638013|OG000|Outcome|Participants Who Completed 015K-CL-RAJ3|Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108980|NCT01638013|OG001|Outcome|Participants Who Completed 015K-CL-RAJ4|Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108981|NCT01638013|OG000|Outcome|Participants Who Completed 015K-CL-RAJ1|Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108982|NCT01638013|EG000|Reported Event|Participants Who Completed 015K-CL-RAJ1|Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108983|NCT01638013|EG001|Reported Event|Participants Who Completed 015K-CL-RAJ3|Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108984|NCT01638013|EG002|Reported Event|Participants Who Completed 015K-CL-RAJ4|Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
11108985|NCT01638052|BG000|Baseline|0.25% Bupivacaine|This is our standard of care concentration
11108986|NCT01638052|BG001|Baseline|0.25% Bupivacaine + Clonidine|"These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.~0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine"
11108987|NCT01638052|BG002|Baseline|Total|Total of all reporting groups
11108988|NCT01638052|FG000|Participant Flow|0.25% Bupivacaine|This is our standard of care concentration
11108989|NCT01638052|FG001|Participant Flow|0.25% Bupivacaine + Clonidine|"These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.~0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine"
11108990|NCT01638052|OG000|Outcome|0.25% Bupivacaine|This is our standard of care concentration
11108991|NCT01638052|OG001|Outcome|0.25% Bupivacaine + Clonidine|"These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.~0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine"
11108992|NCT01638052|EG000|Reported Event|0.25% Bupivacaine|This is our standard of care concentration
11108993|NCT01638052|EG001|Reported Event|0.25% Bupivacaine + Clonidine|"These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.~0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine"
11108994|NCT01638312|BG000|Baseline|"HIV Infected Patients"|The people had infected HIV
11108995|NCT01638312|BG001|Baseline|"Healthy Controls"|The people didn't have infected HIV
11108996|NCT01638312|BG002|Baseline|Total|Total of all reporting groups
11108997|NCT01638312|FG000|Participant Flow|"HIV Infected Patients"|The people had infected HIV
11108998|NCT01638312|FG001|Participant Flow|"Healthy Controls"|The people didn't have infected HIV
11108999|NCT01638312|OG000|Outcome|"HIV Infected Patients"|20 There are six medication negative response, referring to a recent comparison of the value of the blood virus date, there are three items detected waveform error, the remaining non-medication of 14, there are two detection waveform is negative; positive predictive value = 60%
11109000|NCT01638312|OG001|Outcome|"Healthy Controls"|"Healthy people~Graphical analysis of healthy people 1.7 of 30 healthy people were positive in waveform, and 23 were negative, the negative predictive value was 76.67%.~2.Healthy people was subjective judgments of participants, no other test as proof.~3.Graphical analysis of HIV-infected subjects"
11109001|NCT01638312|EG000|Reported Event|"HIV Infected Patients"|Serious and Other (Not Including Serious) Adverse Events were not collected
11109002|NCT01638312|EG001|Reported Event|"Healthy Controls"|Serious and Other (Not Including Serious) Adverse Events were not collected
11109003|NCT01638390|BG000|Baseline|Treatment of Myopia|"The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.~Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D."
11109004|NCT01638390|FG000|Participant Flow|Treatment of Myopia|"The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.~Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D."
11109005|NCT01638390|OG000|Outcome|Treatment of Myopia|"The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.~Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D."
11109006|NCT01638390|OG000|Outcome|Treatment of Myopia|The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
11109007|NCT01638390|OG000|Outcome|Treatment of Myopia|Participants within 1.00 D change
11109008|NCT01638390|OG000|Outcome|Treatment of Myopia|The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D
11109009|NCT01638390|OG000|Outcome|Treatment of Myopia|Reported Adverse Events
11109010|NCT01638390|OG000|Outcome|Treatment of Myopia|Change in contrast sensitivity
11109011|NCT01638390|OG000|Outcome|Treatment of Myopia|Participants within 0.50 D change
11109012|NCT01638390|OG000|Outcome|Treatment of Myopia|Quality of Vision Score Change from Preoperative
11109013|NCT01638390|EG000|Reported Event|Treatment of Myopia|"The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.~Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D."
11109014|NCT01638416|BG000|Baseline|Arm B (Short Term Storage)|"Blood Transfusion Freshest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109015|NCT01638416|BG001|Baseline|Standard of Care (Long Term Storage)|"Blood Transfusion Standard of care- oldest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109016|NCT01638416|BG002|Baseline|Total|Total of all reporting groups
11109017|NCT01638416|FG000|Participant Flow|Arm B (Short Term Storage)|"Blood Transfusion Freshest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109018|NCT01638416|FG001|Participant Flow|Standard of Care (Long-term Storage)|"Blood Transfusion Standard of care- oldest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109019|NCT01638416|OG000|Outcome|Arm B (Short Term Storage)|"Blood Transfusion Freshest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109020|NCT01638416|OG001|Outcome|Standard of Care (Long Term Storage)|"Blood Transfusion Standard of care- oldest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109021|NCT01638416|OG001|Outcome|Standard of Care (Long-term Storage)|"Blood Transfusion Standard of care- oldest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109022|NCT01638416|EG000|Reported Event|Arm B (Short Term Storage)|"Blood Transfusion Freshest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109023|NCT01638416|EG001|Reported Event|Standard of Care (Long Term Storage)|"Blood Transfusion Standard of care- oldest blood.~Blood transfusion: Blood transfusion in ICU patients aged 18 and over."
11109024|NCT01638429|BG000|Baseline|Obese/Overweight, Prediabetic Methane Positive Subjects|"Neomycin Rifaximin~Neomycin: Neomycin: 500mg po bid for 10 days~Rifaximin: Rifaximin: 550mg po tid for 10 days"
11109025|NCT01638429|FG000|Participant Flow|Obese/Overweight, Prediabetic Methane Positive Subjects|"Neomycin Rifaximin~Neomycin: Neomycin: 500mg po bid for 10 days~Rifaximin: Rifaximin: 550mg po tid for 10 days"
11109026|NCT01638429|OG000|Outcome|Obese/Overweight, Prediabetic Methane Positive|"Neomycin Rifaximin~Neomycin: Neomycin: 500mg po bid for 10 days~Rifaximin: Rifaximin: 550mg po tid for 10 days"
11109027|NCT01638429|OG000|Outcome|Methane Eradicators|Subjects who eradicated methane on breath test following antibiotic treatment
11109028|NCT01638429|OG001|Outcome|Methane Non-Eradicators|Subjects who did not eradicate methane on breath test following antibiotic treatment
11109029|NCT01638429|OG000|Outcome|Total Study Population|All subjects (methane eradicators and non-eradicators)
11109030|NCT01638429|OG001|Outcome|Methane Eradicators|Subjects who eradicated methane on breath test following antibiotic treatment
11109031|NCT01638429|EG000|Reported Event|Obese/Overweight, Prediabetic Methane Positive Subjects|"Neomycin Rifaximin~Neomycin: Neomycin: 500mg po bid for 10 days~Rifaximin: Rifaximin: 550mg po tid for 10 days"
11109032|NCT01638468|BG000|Baseline|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
11109033|NCT01638468|FG000|Participant Flow|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
11109034|NCT01638468|OG000|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
11109035|NCT01638468|EG000|Reported Event|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
11109036|NCT01638507|BG000|Baseline|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
11109037|NCT01638507|FG000|Participant Flow|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
11109038|NCT01638507|OG000|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
11109039|NCT01638507|OG000|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
11109040|NCT01638507|OG000|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
11109041|NCT01638507|EG000|Reported Event|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
11109042|NCT01638546|BG000|Baseline|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
11109043|NCT01638546|BG001|Baseline|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
11109044|NCT01638546|BG002|Baseline|Total|Total of all reporting groups
11109045|NCT01638546|FG000|Participant Flow|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
11109046|NCT01638546|FG001|Participant Flow|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
11109047|NCT01638546|OG000|Outcome|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
11109048|NCT01638546|OG001|Outcome|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
11109049|NCT01638546|OG000|Outcome|Arm I (Veliparib and Temozolomide)|Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.
11109050|NCT01638546|OG001|Outcome|Arm II (Placebo and Temozolomide)|Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.
11109051|NCT01638546|EG000|Reported Event|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
11109052|NCT01638546|EG001|Reported Event|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
11109053|NCT01638559|BG000|Baseline|Participants That Initiated Immunosuppression Withdrawal (ISW)|Pediatric liver transplant recipients with stable liver tests (ALT and GGT), no evidence of rejection in the preceding 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
11109054|NCT01638559|FG000|Participant Flow|Participants That Initiated Immunosuppression Withdrawal (ISW)|Pediatric liver transplant recipients with stable liver tests (ALT and GGT), no evidence of rejection in the preceding 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal..
11109055|NCT01638559|OG000|Outcome|Participants That Initiated Immunosuppression Withdrawal (ISW)|Pediatric liver transplant recipients with stable liver tests (ALT and GGT), no evidence of rejection in the preceding 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal..
11109056|NCT01638559|OG000|Outcome|Participants That Initiated Immunosuppression Withdrawal (ISW)|Pediatric liver transplant recipients with stable liver tests (ALT and GGT), no evidence of rejection in the preceding 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
11109057|NCT01638559|OG000|Outcome|Participants That Increased IS Dosing or Restarted IS|Pediatric liver transplant recipients with stable liver tests (ALT and GGT), no evidence of rejection in the preceding 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression (IS) withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful IS withdrawal. These participants either failed IS withdrawal or restarted IS after completing withdrawal.
11109058|NCT01638559|OG000|Outcome|Participants That Experienced BPAR|A subset of the participants that Initiated Immunosuppression Withdrawal (ISW) and experienced biopsy-proved acute rejection (BPAR) with elevated liver function tests at the time of the biopsy were examined for this endpoint.
11109059|NCT01638559|OG000|Outcome|Participants With Adverse Events of BPAR or Clinical Rejection|All participants that initiated withdrawal were at risk for a rejection event and are included in the denominator of the proportion. Participants that had one or more adverse events of Biopsy-Proven Acute Rejection (BPAR) or Clinical Rejection and were treated with each specific treatment regimen are included in the numerator.
11109060|NCT01638559|OG000|Outcome|Participants That Discontinued Immunosuppression Withdrawal|A subset of the Participants that Initiated Withdrawal and discontinued Immunosuppression Withdrawal (ISW) prior to completing withdrawal.
11109061|NCT01638559|OG000|Outcome|Participants That Had Both Screening and End-of-Study Biopsies|Pediatric liver transplant recipients with stable liver tests (ALT and GGT), no evidence of rejection in the preceding 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
11109062|NCT01638559|OG000|Outcome|Participants Deemed Tolerant by Trial Definition|Pediatric liver transplant recipients with stable liver tests (ALT and GGT), no evidence of rejection in the preceding 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
11109063|NCT01638559|OG000|Outcome|Participants That Discontinued Immunosuppression Withdrawal|A subset of the Participants that Initiated Withdrawal and discontinued Immunosuppression Withdrawal prior to completing withdrawal.
11109064|NCT01638559|OG000|Outcome|Participants Not Deemed Tolerant by the Trial Definition|All participants not deemed tolerant by the trial definition either due to discontinuing IS withdrawal or completing withdrawal but not meeting the criteria for tolerance on the primary endpoint biopsy.
11109065|NCT01638559|OG000|Outcome|Participants Were Operationally Tolerant|Participants that Completed Withdrawal and were Operationally Tolerant
11109066|NCT01638559|OG001|Outcome|Participants Who Were Not Operationally Tolerant|Participants who were not operationally tolerant.
11109067|NCT01638559|EG000|Reported Event|All Enrolled Participants|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
11109068|NCT01638819|BG000|Baseline|Autologous Cord Blood Stem Cells First/Placebo Second|"Autologous Cord Blood Stem Cells: One infusion of 60 ml syringe of study product~Placebo: Saline"
11109069|NCT01638819|BG001|Baseline|Placebo First/Autologous Cord Blood Stem Cells Second|"Autologous Cord Blood Stem Cells: One infusion of 60 ml syringe of study product~Placebo: Saline"
11109070|NCT01638819|BG002|Baseline|Total|Total of all reporting groups
11109071|NCT01638819|FG000|Participant Flow|Autologous Cord Blood Stem Cells First/Placebo Second|"Autologous Cord Blood Stem Cells: One infusion of 60 ml syringe of study product~Placebo: Saline"
11109072|NCT01638819|FG001|Participant Flow|Placebo First/Autologous Cord Blood Stem Cells Second|"Autologous Cord Blood Stem Cells: One infusion of 60 ml syringe of study product~Placebo: Saline"
11109073|NCT01638819|OG000|Outcome|Autologous Cord Blood Stem Cells|Autologous Cord Blood Stem Cells: One infusion of 60 ml syringe of study product
11109074|NCT01638819|OG001|Outcome|Placebo|Placebo: Saline
11109075|NCT01638819|EG000|Reported Event|All Participants|Adverse events were measured for all participants throughout the study and not by arm since both arms received stem cell cord blood infusion.
11109076|NCT01639001|BG000|Baseline|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit. The maximum duration of crizotinib treatment was 324.4 weeks.
11109077|NCT01639001|BG001|Baseline|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks.
11109078|NCT01639001|BG002|Baseline|Total|Total of all reporting groups
11109079|NCT01639001|FG000|Participant Flow|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit. The maximum duration of crizotinib treatment was 324.4 weeks.
11109080|NCT01639001|FG001|Participant Flow|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks.
11109081|NCT01639001|OG000|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit. The maximum duration of crizotinib treatment was 324.4 weeks.
11109082|NCT01639001|OG001|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks.
11109083|NCT01639001|OG000|Outcome|Participants With Positive ALK FISH Status|Participants in the Molecular Profiling Evaluable population that had positive ALK FISH results.
11109084|NCT01639001|OG001|Outcome|Participants With Negative ALK FISH Status|Participants in the Molecular Profiling Evaluable population that had negative ALK FISH results.
11109085|NCT01639001|EG000|Reported Event|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit. The maximum duration of crizotinib treatment was 324.4 weeks.
11109086|NCT01639001|EG001|Reported Event|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks.
11109087|NCT01639040|BG000|Baseline|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
11109088|NCT01639040|BG001|Baseline|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
11109089|NCT01639040|BG002|Baseline|Total|Total of all reporting groups
11109090|NCT01639040|FG000|Participant Flow|Placebo QW|Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days.
11109091|NCT01639040|FG001|Participant Flow|Dupilumab 300 mg QW|Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
11109092|NCT01639040|OG000|Outcome|Placebo QW|Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days
11109093|NCT01639040|OG001|Outcome|Dupilumab 300 mg QW|Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
11109094|NCT01639040|OG000|Outcome|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
11109095|NCT01639040|OG001|Outcome|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
11109096|NCT01639040|OG000|Outcome|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
11109097|NCT01639040|EG000|Reported Event|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
11109098|NCT01639040|EG001|Reported Event|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
11109099|NCT01639144|BG000|Baseline|Receiving PRP and PPP.|"Administration of PRP and PPP to surgical site.~PRP and PPP: Autogenous PRP and PPP"
11109100|NCT01639144|BG001|Baseline|Control|Group not receiving autogenous PRP and PPP.
11109101|NCT01639144|BG002|Baseline|Total|Total of all reporting groups
11109102|NCT01639144|FG000|Participant Flow|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
11109103|NCT01639144|FG001|Participant Flow|Control|Group not receiving autogenous PRP and PPP.
11109104|NCT01639144|OG000|Outcome|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
11109105|NCT01639144|OG001|Outcome|Control|Group not receiving autogenous PRP and PPP.
11109106|NCT01639144|EG000|Reported Event|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
11109107|NCT01639144|EG001|Reported Event|Control|Group not receiving autogenous PRP and PPP.
11109108|NCT01639157|BG000|Baseline|All Study Participants|Subjects were maintained on oral buspirone (10 mg administered 3 times daily) or placebo for 6 days each during the study in random order.
11109109|NCT01639157|FG000|Participant Flow|Buspirone Then Placebo|Subjects were maintained on 30 mg buspirone daily for 6 days, then they were crossed over to placebo daily for 6 days.
11109110|NCT01639157|FG001|Participant Flow|Placebo Then Buspirone|Subjects were maintained on placebo daily for 6 days, then they were crossed over to 30 mg buspirone daily for 6 days.
11109111|NCT01639157|OG000|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
11109112|NCT01639157|OG001|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
11109113|NCT01639157|EG000|Reported Event|Buspirone|"Subjects will be maintained on buspirone.~Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order. These subjects will be the same as those who are maintained on placebo (i.e., the study uses a within-subjects design)."
11109114|NCT01639157|EG001|Reported Event|Placebo|"Subjects will be maintained on placebo.~Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order.These subjects will be the same as those who are maintained on buspirone (i.e., the study uses a within-subjects design)."
11109115|NCT01639222|BG000|Baseline|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.~Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
11109116|NCT01639222|FG000|Participant Flow|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.~Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
11109117|NCT01639222|OG000|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
11109118|NCT01639222|OG001|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
11109119|NCT01639222|EG000|Reported Event|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
11109120|NCT01639222|EG001|Reported Event|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
11109121|NCT01639339|BG000|Baseline|Placebo to Belimumab 10 mg/kg|Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
11109122|NCT01639339|BG001|Baseline|Belimumab 10 mg/kg to Belimumab 10|Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
11109123|NCT01639339|BG002|Baseline|Total|Total of all reporting groups
11109124|NCT01639339|FG000|Participant Flow|Placebo to Belimumab 10 mg/kg|Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
11109125|NCT01639339|FG001|Participant Flow|Belimumab 10 mg/kg to Belimumab 10|Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
11109126|NCT01639339|OG000|Outcome|Placebo|Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
11109127|NCT01639339|OG001|Outcome|Belimumab 10 mg/kg|Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
11109128|NCT01639339|OG000|Outcome|Placebo to Belimumab 10 mg/kg|Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
11109129|NCT01639339|OG001|Outcome|Belimumab 10 mg/kg to Belimumab 10 mg/kg|Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
11109130|NCT01639339|EG000|Reported Event|Placebo|Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
11109131|NCT01639339|EG001|Reported Event|Belimumab 10 mg/kg|Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
11109132|NCT01639339|EG002|Reported Event|Placebo to Belimumab 10 mg/kg|Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
11109133|NCT01639339|EG003|Reported Event|Belimumab 10 mg/kg to Belimumab 10 mg/kg|Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
11109134|NCT01639352|BG000|Baseline|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
11109135|NCT01639352|FG000|Participant Flow|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
11109136|NCT01639352|OG000|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
11109137|NCT01639352|EG000|Reported Event|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
11109138|NCT01639443|BG000|Baseline|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
11109139|NCT01639443|BG001|Baseline|Control|Patients who are scheduled routinely
11109140|NCT01639443|BG002|Baseline|Total|Total of all reporting groups
11109141|NCT01639443|FG000|Participant Flow|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
11109142|NCT01639443|FG001|Participant Flow|Control|Patients who are scheduled routinely
11109143|NCT01639443|OG000|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
11109144|NCT01639443|OG001|Outcome|Control|Patients who are scheduled routinely
11109145|NCT01639443|EG000|Reported Event|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
11109146|NCT01639443|EG001|Reported Event|Control|Patients who are scheduled routinely
11109147|NCT01639469|BG000|Baseline|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
11109148|NCT01639469|BG001|Baseline|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
11109149|NCT01639469|BG002|Baseline|Total|Total of all reporting groups
11109150|NCT01639469|FG000|Participant Flow|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
11109151|NCT01639469|FG001|Participant Flow|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
11109152|NCT01639469|OG000|Outcome|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
11109153|NCT01639469|OG001|Outcome|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
11109154|NCT01639469|EG000|Reported Event|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
11109155|NCT01639469|EG001|Reported Event|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
11109156|NCT01639495|BG000|Baseline|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
11109157|NCT01639495|FG000|Participant Flow|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
10879526|NCT00458341|OG001|Outcome|Ataluren 10, 10, and 20 mg/kg, Then Ataluren 4, 4, and 8 mg/kg|During Cycle 1, participants received ataluren at 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. Then, the participants crossed over to the other ataluren dose regimen (ataluren 4, 4, and 8 mg/kg) for Cycle 2.
11109158|NCT01639495|OG000|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
11109159|NCT01639495|EG000|Reported Event|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
11109160|NCT01639560|BG000|Baseline|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
11109161|NCT01639560|BG001|Baseline|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
11109162|NCT01639560|BG002|Baseline|Total|Total of all reporting groups
11109163|NCT01639560|FG000|Participant Flow|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
11109164|NCT01639560|FG001|Participant Flow|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
11109165|NCT01639560|OG000|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
11109166|NCT01639560|OG001|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
11109167|NCT01639560|EG000|Reported Event|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
11109168|NCT01639560|EG001|Reported Event|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
11109169|NCT01639599|BG000|Baseline|Dexamethasone|"dexamethasone 5mg iv during anesthesia induction~Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction"
11109170|NCT01639599|BG001|Baseline|Dexamethasone, Haloperiol 1mg|"dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia~Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg"
11109171|NCT01639599|BG002|Baseline|Dexamethasone + Haloperidol 2mg|"dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia~Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg"
11109172|NCT01639599|BG003|Baseline|Total|Total of all reporting groups
11109173|NCT01639599|FG000|Participant Flow|Dexamethasone|"dexamethasone 5mg iv during anesthesia induction~Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction"
11109174|NCT01639599|FG001|Participant Flow|Dexamethasone, Haloperiol 1mg|"dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia~Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg"
11109175|NCT01639599|FG002|Participant Flow|Dexamethasone + Haloperidol 2mg|"dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia~Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg"
11109176|NCT01639599|OG000|Outcome|Dexamethasone|"dexamethasone 5mg iv during anesthesia induction~Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction"
11109177|NCT01639599|OG001|Outcome|Dexamethasone, Haloperiol 1mg|"dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia~Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg"
11109178|NCT01639599|OG002|Outcome|Dexamethasone + Haloperidol 2mg|"dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia~Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg"
11109179|NCT01639599|EG000|Reported Event|Dexamethasone|"dexamethasone 5mg iv during anesthesia induction~Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction"
11109180|NCT01639599|EG001|Reported Event|Dexamethasone, Haloperiol 1mg|"dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia~Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg"
11109181|NCT01639599|EG002|Reported Event|Dexamethasone + Haloperidol 2mg|"dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia~Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg"
11109182|NCT01639664|BG000|Baseline|High Doses CPFA|High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization.
11109183|NCT01639664|BG001|Baseline|Control Group|Standard practice
11109184|NCT01639664|BG002|Baseline|Total|Total of all reporting groups
11109185|NCT01639664|FG000|Participant Flow|High Doses CPFA|High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization and on each of the subsequent days in which the patient is still in septic-shock condition.
11109186|NCT01639664|FG001|Participant Flow|Control Group|standard practice
11109187|NCT01639664|OG000|Outcome|High Doses CPFA|High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization.
11109188|NCT01639664|OG001|Outcome|Control|Standard practice
11109189|NCT01639664|OG001|Outcome|Control Group|Standard practice
11109190|NCT01639664|EG000|Reported Event|High Doses CPFA|"High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization.~High doses CPFA: High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization."
11109191|NCT01639664|EG001|Reported Event|Control Group|standard practice
11109192|NCT01639703|BG000|Baseline|All Included Patients|All patients included in the study.
11109193|NCT01639703|FG000|Participant Flow|CT Perfusion|Xenetix-CT perfusion imaging: Injection of 50 ml of Xenetix
11109194|NCT01639703|OG000|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed for CT perfusion parameters, 47 were well differentiated according to WHO classification.
11109195|NCT01639703|OG001|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
11109196|NCT01639703|OG000|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
11109197|NCT01639703|OG000|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification
11109198|NCT01639703|OG000|Outcome|Glutamine Synthetase 0%|Absence of glutamine synthetase labelling
11109199|NCT01639703|OG001|Outcome|Glutamine Synthetase 1-10%|Quantification of glutamine synthetase labelling from 1 to 10%
11109200|NCT01639703|OG002|Outcome|Glutamine Synthetase 10-50%|Quantification of glutamine synthetase labelling from 10 to 50%
11109201|NCT01639703|OG003|Outcome|Glutamine Synthetase >50%|Quantification of glutamine synthetase labelling greater than 50%
11109202|NCT01639703|OG000|Outcome|CD31 0%|Absence of CD31 labelling
11109203|NCT01639703|OG001|Outcome|CD31 1-10%|Quantification of CD31 labelling from 1 to 10%
11109204|NCT01639703|OG002|Outcome|CD31 10-50%|Quantification of CD31 labelling from 10 to 50%
11109205|NCT01639703|OG003|Outcome|CD31 >50%|Quantification of CD31 labelling greater than 50%
11109206|NCT01639703|OG000|Outcome|CD31 0%|Absence of glutamine synthetase labelling
11109207|NCT01639703|EG000|Reported Event|Safety Set|All included patients receiving at least one injection of Xenetix, regardless of the quantity. This set was used for safety analyses.
11109208|NCT01639729|BG000|Baseline|Treatment A, Followed by Treatment B, C and D in Random Order|Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) Sequence 1: A, B, C, D Sequence 2: A, B, D, C Sequence 3: A, C, B, D Sequence 4: A, C, D, B Sequence 5: A, D, B, C Sequence 6: A, D, C, B A 48-hour washout period separated each treatment period. The washout began with the start of dosing.
11109209|NCT01639729|FG000|Participant Flow|Sequence 1: Treatment A, B, C, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
11109210|NCT01639729|FG001|Participant Flow|Sequence 2: A, B, D, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
11109211|NCT01639729|FG002|Participant Flow|Sequence 3: Treatment A, C, B, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
11109212|NCT01639729|FG003|Participant Flow|Sequence 4: Treatment A, C, D, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
11109213|NCT01639729|FG004|Participant Flow|Sequence Five: Treatments A, D, B, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
11109214|NCT01639729|FG005|Participant Flow|Sequence 6: Treatments A, D, C, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
11109215|NCT01639729|OG000|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
11109216|NCT01639729|OG001|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
11109217|NCT01639729|OG002|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
11109218|NCT01639729|OG003|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
11109219|NCT01639729|EG000|Reported Event|Sufentanil IV|Sufentanil : 15 mcg IV
11109220|NCT01639729|EG001|Reported Event|Sufentanil NanoTab Buccal|Sufentanil : 15 mcg buccal
11109221|NCT01639729|EG002|Reported Event|Sufentanil NanoTab Sublingual|Sufentanil : 15 mcg sublingaul
11109222|NCT01639729|EG003|Reported Event|Sufentanil NanoTab Oral|Sufentanil : 15 mcg oral
11109223|NCT01639742|BG000|Baseline|All Participants|All participants who had new texture round breast implants surgically implanted.
11109224|NCT01639742|FG000|Participant Flow|All Participants|All participants who had new texture round breast implants surgically implanted.
11109225|NCT01639742|OG000|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
11109226|NCT01639742|EG000|Reported Event|All Participants|All participants who had new texture round breast implants surgically implanted.
11109227|NCT01639755|BG000|Baseline|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
11109228|NCT01639755|FG000|Participant Flow|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
11109229|NCT01639755|OG000|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
11109230|NCT01639755|EG000|Reported Event|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
11109231|NCT01639833|BG000|Baseline|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
11109232|NCT01639833|BG001|Baseline|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
11109233|NCT01639833|BG002|Baseline|Total|Total of all reporting groups
11109234|NCT01639833|FG000|Participant Flow|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
11109235|NCT01639833|FG001|Participant Flow|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
11109236|NCT01639833|OG000|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
11109237|NCT01639833|OG001|Outcome|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
11109238|NCT01639833|EG000|Reported Event|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
11109239|NCT01639833|EG001|Reported Event|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
11109240|NCT01639872|BG000|Baseline|Clozapine|"The blinded CLOZ will be titrated on a recommended standard schedule, supervised by a study physician (or other prescriber) who can make the necessary adjustments to account for symptom control and tolerability. The titration is recommended to begin at 12.5 mg and then increase while the open-label base antipsychotic is tapered with a recommended goal of decreasing the base antipsychotic by 25% each week. If clinically tolerated, the target dose of CLOZ is 400 mg/day.~Clozapine: Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day"
11109241|NCT01639872|BG001|Baseline|Risperidone|"The blinded RISP will also be titrated in the first weeks, using a titration schedule, with a target dose of 4 mg/day, while the open label base antipsychotic is tapered in a similar fashion.~Risperidone: Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day"
11109242|NCT01639872|BG002|Baseline|Total|Total of all reporting groups
11109243|NCT01639872|FG000|Participant Flow|Clozapine|"The blinded CLOZ will be titrated on a recommended standard schedule, supervised by a study physician (or other prescriber) who can make the necessary adjustments to account for symptom control and tolerability. The titration is recommended to begin at 12.5 mg and then increase while the open-label base antipsychotic is tapered with a recommended goal of decreasing the base antipsychotic by 25% each week. If clinically tolerated, the target dose of CLOZ is 400 mg/day.~Clozapine: Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day"
11109244|NCT01639872|FG001|Participant Flow|Risperidone|"The blinded RISP will also be titrated in the first weeks, using a titration schedule, with a target dose of 4 mg/day, while the open label base antipsychotic is tapered in a similar fashion.~Risperidone: Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day"
11109245|NCT01639872|OG000|Outcome|Clozapine|"The blinded CLOZ will be titrated on a recommended standard schedule, supervised by a study physician (or other prescriber) who can make the necessary adjustments to account for symptom control and tolerability. The titration is recommended to begin at 12.5 mg and then increase while the open-label base antipsychotic is tapered with a recommended goal of decreasing the base antipsychotic by 25% each week. If clinically tolerated, the target dose of CLOZ is 400 mg/day.~Clozapine: Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day"
10846835|NCT00280241|BG000|Baseline|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
11109246|NCT01639872|OG001|Outcome|Risperidone|"The blinded RISP will also be titrated in the first weeks, using a titration schedule, with a target dose of 4 mg/day, while the open label base antipsychotic is tapered in a similar fashion.~Risperidone: Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day"
11109247|NCT01639872|EG000|Reported Event|Clozapine|"The blinded CLOZ will be titrated on a recommended standard schedule, supervised by a study physician (or other prescriber) who can make the necessary adjustments to account for symptom control and tolerability. The titration is recommended to begin at 12.5 mg and then increase while the open-label base antipsychotic is tapered with a recommended goal of decreasing the base antipsychotic by 25% each week. If clinically tolerated, the target dose of CLOZ is 400 mg/day.~Clozapine: Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day"
11109248|NCT01639872|EG001|Reported Event|Risperidone|"The blinded RISP will also be titrated in the first weeks, using a titration schedule, with a target dose of 4 mg/day, while the open label base antipsychotic is tapered in a similar fashion.~Risperidone: Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day"
11109249|NCT01640054|BG000|Baseline|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
11109250|NCT01640054|FG000|Participant Flow|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
11109251|NCT01640054|OG000|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
11109252|NCT01640054|EG000|Reported Event|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
11109253|NCT01640171|BG000|Baseline|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow Eye:~Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
11109254|NCT01640171|FG000|Participant Flow|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye Same as above plus Xylocaine 2% SC"
11109255|NCT01640171|OG000|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
11109256|NCT01640171|EG000|Reported Event|Topical Anesthesia|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
11109257|NCT01640171|EG001|Reported Event|Subconjunctival Anesthesia|"Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
11109258|NCT01640184|BG000|Baseline|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
11109259|NCT01640184|BG001|Baseline|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
11109260|NCT01640184|BG002|Baseline|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
11109261|NCT01640184|BG003|Baseline|Total|Total of all reporting groups
11109262|NCT01640184|FG000|Participant Flow|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
11109263|NCT01640184|FG001|Participant Flow|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
11109264|NCT01640184|FG002|Participant Flow|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
11109265|NCT01640184|OG000|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
11109266|NCT01640184|OG001|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
11109267|NCT01640184|OG002|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
10879527|NCT00458341|EG000|Reported Event|Ataluren 4, 4, and 8 mg/kg|Participants received ataluren at 4 milligrams in the morning, 4 mg/kg at midday, and 8 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment.
11109268|NCT01640184|OG000|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
11109269|NCT01640184|OG001|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
11109270|NCT01640184|OG000|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
11109271|NCT01640184|EG000|Reported Event|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
11109272|NCT01640184|EG001|Reported Event|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
11109273|NCT01640184|EG002|Reported Event|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
11109274|NCT01640197|BG000|Baseline|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
11109275|NCT01640197|BG001|Baseline|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
11109276|NCT01640197|BG002|Baseline|Total|Total of all reporting groups
11109277|NCT01640197|FG000|Participant Flow|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
11109278|NCT01640197|FG001|Participant Flow|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
11109279|NCT01640197|OG000|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
11109280|NCT01640197|OG001|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
11109281|NCT01640197|EG000|Reported Event|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
11109282|NCT01640197|EG001|Reported Event|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
11109283|NCT01640249|BG000|Baseline|Cohort 1 (Sequence 1)|"Participants received LY3006072 and Placebo capsules as per below dosing schedules.~Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo"
11109284|NCT01640249|BG001|Baseline|Cohort 1 (Sequence 2)|"Participants received LY3006072 and Placebo capsules as per below dosing schedules.~Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072"
11109285|NCT01640249|BG002|Baseline|Cohort 1 (Sequence 3)|"Participants received LY3006072 and Placebo capsules as per below dosing schedule.~Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072"
11109286|NCT01640249|BG003|Baseline|Cohort 1 (Sequence 4)|"Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule.~Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072"
11109287|NCT01640249|BG004|Baseline|Cohort 2 (Sequence 1)|"Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule.~Period 1: Placebo and Period 2: 20 mg LY3006072"
11109288|NCT01640249|BG005|Baseline|Cohort 2 (Sequence 2)|"Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule.~Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072"
11109289|NCT01640249|BG006|Baseline|Cohort 2 (Sequence 3)|"Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule.~Period 1: 3 mg LY3006072 and Period 2: Placebo"
11109290|NCT01640249|BG007|Baseline|Total|Total of all reporting groups
11109291|NCT01640249|FG000|Participant Flow|Cohort 1 (Sequence 1)|"Participants received LY3006072 and Placebo capsules as per below dosing schedules.~Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo"
11109292|NCT01640249|FG001|Participant Flow|Cohort 1 (Sequence 2)|"Participants received LY3006072 and Placebo capsules as per below dosing schedules.~Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072"
11109293|NCT01640249|FG002|Participant Flow|Cohort 1 Sequence 3|"Participants received LY3006072 and Placebo capsules as per below dosing schedule.~Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072"
11109294|NCT01640249|FG003|Participant Flow|Cohort 1 Sequence 4|"Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule.~Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072"
11109295|NCT01640249|FG004|Participant Flow|Cohort 2 (Sequence 1)|"Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule.~Period 1: Placebo and Period 2: 20 mg LY3006072"
11109296|NCT01640249|FG005|Participant Flow|Cohort 2 (Sequence 2)|"Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule.~Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072"
11109297|NCT01640249|FG006|Participant Flow|Cohort 2 (Sequence 3)|"Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule.~Period 1: 3 mg LY3006072 and Period 2: Placebo"
11109298|NCT01640249|OG000|Outcome|Placebo|Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109299|NCT01640249|OG001|Outcome|1 mg LY3006072|Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109300|NCT01640249|OG002|Outcome|3 mg LY3006072|Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109301|NCT01640249|OG003|Outcome|10 mg LY3006072|Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109302|NCT01640249|OG004|Outcome|20 mg LY3006072|Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109303|NCT01640249|OG005|Outcome|40 mg LY3006072|Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109304|NCT01640249|OG000|Outcome|1 mg LY3006072|Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109305|NCT01640249|OG001|Outcome|3 mg LY3006072|Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109306|NCT01640249|OG002|Outcome|10 mg LY3006072|Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109307|NCT01640249|OG003|Outcome|20 mg LY3006072|Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109308|NCT01640249|OG004|Outcome|40 mg LY3006072|Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109309|NCT01640249|EG000|Reported Event|Placebo|Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109310|NCT01640249|EG001|Reported Event|1 mg LY3006072|Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109311|NCT01640249|EG002|Reported Event|3 mg LY3006072|Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109312|NCT01640249|EG003|Reported Event|10 mg LY3006072|Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109313|NCT01640249|EG004|Reported Event|20 mg LY3006072|Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109314|NCT01640249|EG005|Reported Event|40 mg LY3006072|Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
11109315|NCT01640288|BG000|Baseline|Normal Subjects|"Subjects with Normal Lung Function by Pulmonary Function Tests (e.g. Spirometry) with or without smoking as a risk factor (non-smokers, ex-smokers, current smokers)~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109316|NCT01640288|BG001|Baseline|Subjects With COPD|"Subjects diagnosed with COPD by GOLD criteria.~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109317|NCT01640288|BG002|Baseline|Total|Total of all reporting groups
11109318|NCT01640288|FG000|Participant Flow|Normal Subjects|"Subjects with Normal Lung Function by Pulmonary Function Tests (e.g. Spirometry) with or without smoking as a risk factor (non-smokers, ex-smokers, current smokers)~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109319|NCT01640288|FG001|Participant Flow|Subjects With COPD|"Subjects diagnosed with COPD by GOLD criteria.~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109320|NCT01640288|OG000|Outcome|Normal Subjects|"Subjects with Normal Lung Function by Pulmonary Function Tests (e.g. Spirometry) with or without smoking as a risk factor (non-smokers, ex-smokers, current smokers)~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109321|NCT01640288|OG001|Outcome|Subjects With COPD|"Subjects diagnosed with COPD by GOLD criteria, specifically FEV1/FVC.~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109322|NCT01640288|OG001|Outcome|Subjects With COPD|"Subjects diagnosed with COPD by GOLD criteria.~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109323|NCT01640288|EG000|Reported Event|Normal Subjects|"Subjects with Normal Lung Function by Pulmonary Function Tests (e.g. Spirometry) with or without smoking as a risk factor (non-smokers, ex-smokers, current smokers)~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109324|NCT01640288|EG001|Reported Event|Subjects With COPD|"Subjects diagnosed with COPD by GOLD criteria.~Perfluorinated Gas/Oxygen Mixture: 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour~High Resolution CT of the Chest: High Resolution CT of the Chest, single visit"
11109325|NCT01640314|BG000|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
11109326|NCT01640314|BG001|Baseline|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
11109327|NCT01640314|BG002|Baseline|Total|Total of all reporting groups
11109328|NCT01640314|FG000|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
11109329|NCT01640314|FG001|Participant Flow|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
11109330|NCT01640314|OG000|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
11109331|NCT01640314|OG001|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
11109332|NCT01640314|EG000|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
11109333|NCT01640314|EG001|Reported Event|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
11109334|NCT01640327|BG000|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
11109335|NCT01640327|BG001|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
11109336|NCT01640327|BG002|Baseline|Total|Total of all reporting groups
11109337|NCT01640327|FG000|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
11109338|NCT01640327|FG001|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
11109339|NCT01640327|OG000|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
11109340|NCT01640327|OG001|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
11109341|NCT01640327|EG000|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
11109342|NCT01640327|EG001|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
11109343|NCT01640340|BG000|Baseline|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
11109344|NCT01640340|BG001|Baseline|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
11109345|NCT01640340|BG002|Baseline|Total|Total of all reporting groups
11109346|NCT01640340|FG000|Participant Flow|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg days 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
11109347|NCT01640340|FG001|Participant Flow|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
11109348|NCT01640340|OG000|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
11109349|NCT01640340|OG001|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
11109350|NCT01640340|EG000|Reported Event|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
11109351|NCT01640340|EG001|Reported Event|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
11109352|NCT01640353|BG000|Baseline|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
11109353|NCT01640353|FG000|Participant Flow|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
11109354|NCT01640353|OG000|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
11109355|NCT01640353|EG000|Reported Event|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
11109356|NCT01640366|BG000|Baseline|PICO Negative Pressure Wound Therapy/Standard of Care Dressing|PICO (single-use Negative Pressure Wound Therapy system [su-NPWT]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
11109357|NCT01640366|FG000|Participant Flow|PICO Negative Pressure Wound Therapy/Standard of Care Dressing|PICO (single-use Negative Pressure Wound Therapy system [su-NPWT]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
11109358|NCT01640366|OG000|Outcome|PICO Negative Pressure Wound Therapy/Standard of Care Dressing|PICO (single-use Negative Pressure Wound Therapy system [su-NPWT]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
11109359|NCT01640366|OG000|Outcome|PICO Negative Pressure Wound Therapy|PICO: Single-use Negative Pressure Wound Therapy system (su-NPWT)
11109360|NCT01640366|EG000|Reported Event|PICO Negative Pressure Wound Therapy|PICO: Single-use Negative Pressure Wound Therapy system (su-NPWT)
11109361|NCT01640366|EG001|Reported Event|Standard of Care Dressing Arm|Adhesive Skin Closure Strips, e.g. STERI-Strips, or alternatively a non-adherent dry dressing if Adhesive Skin Closure Strips was not deemed appropriate by the Principle Investigator at that center.
11109362|NCT01640379|BG000|Baseline|Intervention|Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
11109363|NCT01640379|BG001|Baseline|Control|Participants receive enhanced standard of care
11109364|NCT01640379|BG002|Baseline|Total|Total of all reporting groups
11109365|NCT01640379|FG000|Participant Flow|Intervention|Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
11109366|NCT01640379|FG001|Participant Flow|Control|Participants receive enhanced standard of care
11109367|NCT01640379|OG000|Outcome|TECH-N|"Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support~Technology Enhanced Community Health Nursing: -Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)~-Enhanced community health nursing visit on day 3-5, includes DEBI STI/HIV prevention component (Sister to Sister Teen)"
11109368|NCT01640379|OG001|Outcome|Control|Participants receive enhanced standard of care
11109369|NCT01640379|OG000|Outcome|TECH-N|"Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support~Technology Enhanced Community Health Nursing: -Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)~-Enhanced community health nursing visit on day 3-5, includes evidence-based STI/HIV prevention component (Sister to Sister Teen)"
11109370|NCT01640379|EG000|Reported Event|Intervention|Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
11109371|NCT01640379|EG001|Reported Event|Control|Participants receive enhanced standard of care
11109372|NCT01640548|BG000|Baseline|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
11109373|NCT01640548|FG000|Participant Flow|Rheumatoid Arthritis (RA) Cohort|Participants on biologic disease modifying anti-rheumatic drug (bDMARD) monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
11109374|NCT01640548|OG000|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
11109375|NCT01640548|EG000|Reported Event|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
11109376|NCT01640808|BG000|Baseline|NIK-333(Peretinoin)|NIK-333(peretinoin): 600mg (8 x 75mg capsules) orally, twice a day
11109377|NCT01640808|BG001|Baseline|Placebo|Placebo: Placebo (8 x Placebo capsules) orally, twice a day
11109378|NCT01640808|BG002|Baseline|Total|Total of all reporting groups
11109379|NCT01640808|FG000|Participant Flow|NIK-333(Peretinoin)|NIK-333(peretinoin): 600mg (8 x 75mg capsules) orally, twice a day
11109380|NCT01640808|FG001|Participant Flow|Placebo|Placebo: Placebo (8 x Placebo capsules) orally, twice a day
11109381|NCT01640808|OG000|Outcome|NIK-333(Peretinoin)|NIK-333(peretinoin): 600mg (8 x 75mg capsules) orally, twice a day
11109382|NCT01640808|OG001|Outcome|Placebo|Placebo: Placebo (8 x Placebo capsules) orally, twice a day
11109383|NCT01640808|EG000|Reported Event|NIK-333(Peretinoin)|NIK-333(peretinoin): 600mg (8 x 75mg capsules) orally, twice a day
11109384|NCT01640808|EG001|Reported Event|Placebo|Placebo: Placebo (8 x Placebo capsules) orally, twice a day
11109385|NCT01640834|BG000|Baseline|100 mg LY2409021|"LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.~Placebo: 2 capsules, administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109386|NCT01640834|BG001|Baseline|300 mg LY2409021|"LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109387|NCT01640834|BG002|Baseline|Placebo|"Placebo: 3 capsules administered as a single oral dose on Day 2.~Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3."
11109388|NCT01640834|BG003|Baseline|Total|Total of all reporting groups
11109389|NCT01640834|FG000|Participant Flow|100 mg LY2409021|"LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.~Placebo: 2 capsules, administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109390|NCT01640834|FG001|Participant Flow|300 mg LY2409021|"LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109391|NCT01640834|FG002|Participant Flow|Placebo|"Placebo: 3 capsules administered as a single oral dose on Day 2.~Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3."
11109392|NCT01640834|OG000|Outcome|100 mg LY2409021|"LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.~Placebo: 2 capsules, administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109393|NCT01640834|OG001|Outcome|300 mg LY2409021|"LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109394|NCT01640834|OG002|Outcome|Placebo|"Placebo: 3 capsules administered as a single oral dose on Day 2.~Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3."
11109395|NCT01640834|OG000|Outcome|100 mg LY2409021|"LY2409021: 100 milligrams (mg), capsule, administered as a single oral dose on Day 2.~Placebo: 2 capsules, administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109396|NCT01640834|OG001|Outcome|300 mg LY2409021|"LY2409021: 300 milligrams (mg), capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109397|NCT01640834|EG000|Reported Event|100 mg LY2409021|"LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.~Placebo: 2 capsules, administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109398|NCT01640834|EG001|Reported Event|300 mg LY2409021|"LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.~Glucagon: 1 mg administered via intramuscular injection on Day 3."
11109399|NCT01640834|EG002|Reported Event|Placebo|"Placebo: 3 capsules administered as a single oral dose on Day 2.~Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3."
11109400|NCT01640873|BG000|Baseline|MK-8655 80 mg/MK-8655 320 mg|Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
11109401|NCT01640873|BG001|Baseline|Placebo|Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
11109402|NCT01640873|BG002|Baseline|Total|Total of all reporting groups
11109403|NCT01640873|FG000|Participant Flow|MK-8655 80 mg/MK-8655 320 mg|Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
11109404|NCT01640873|FG001|Participant Flow|Placebo|Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
11109405|NCT01640873|OG000|Outcome|MK-8655 80 mg/MK-8655 320 mg|Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
11109406|NCT01640873|OG001|Outcome|Placebo|Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
11109407|NCT01640873|EG000|Reported Event|MK-8655 80 mg/MK-8655 320 mg|Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
11109408|NCT01640873|EG001|Reported Event|Placebo|Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
11109409|NCT01640925|BG000|Baseline|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
11109410|NCT01640925|BG001|Baseline|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
11109411|NCT01640925|BG002|Baseline|Total|Total of all reporting groups
11109412|NCT01640925|FG000|Participant Flow|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
11109413|NCT01640925|FG001|Participant Flow|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
11109414|NCT01640925|OG000|Outcome|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
11109415|NCT01640925|OG001|Outcome|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
11109416|NCT01640925|EG000|Reported Event|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
11109417|NCT01640925|EG001|Reported Event|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
11109418|NCT01640951|BG000|Baseline|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
11109419|NCT01640951|BG001|Baseline|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
11109420|NCT01640951|BG002|Baseline|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
11109421|NCT01640951|BG003|Baseline|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
11109422|NCT01640951|BG004|Baseline|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
11109423|NCT01640951|BG005|Baseline|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
11109424|NCT01640951|BG006|Baseline|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
11109425|NCT01640951|BG007|Baseline|AIN300 OL|AIN457 300 mg Open-label (OL)
11109426|NCT01640951|BG008|Baseline|Total|Total of all reporting groups
11109427|NCT01640951|FG000|Participant Flow|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
11109428|NCT01640951|FG001|Participant Flow|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
11109429|NCT01640951|FG002|Participant Flow|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
11109430|NCT01640951|FG003|Participant Flow|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
11109431|NCT01640951|FG004|Participant Flow|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
11109432|NCT01640951|FG005|Participant Flow|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
11109433|NCT01640951|FG006|Participant Flow|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
11109434|NCT01640951|FG007|Participant Flow|AIN300 OL|AIN457 300 mg Open-label (OL)
11109435|NCT01640951|OG000|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
11109436|NCT01640951|OG001|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
11109437|NCT01640951|OG002|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
11109438|NCT01640951|OG003|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
11109439|NCT01640951|OG004|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
11109440|NCT01640951|OG005|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
11109441|NCT01640951|OG006|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
11109442|NCT01640951|OG007|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
11109443|NCT01640951|OG002|Outcome|AIN150FI (NSW+SW)|AIN457 150 mg - Fixed Interval combined non-switch and switch
11109444|NCT01640951|OG003|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
11109445|NCT01640951|OG004|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
11109446|NCT01640951|OG005|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
11109447|NCT01640951|OG006|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
11109448|NCT01640951|OG007|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
11109449|NCT01640951|OG008|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
11109450|NCT01640951|EG000|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
11109451|NCT01640951|EG001|Reported Event|Any AIN457 300 mg|Any AIN457 300 mg
11109452|NCT01640951|EG002|Reported Event|Any AIN457 Dose|Any AIN457 dose
11109453|NCT01640964|BG000|Baseline|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
11109454|NCT01640964|BG001|Baseline|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
11109455|NCT01640964|BG002|Baseline|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
11109456|NCT01640964|BG003|Baseline|Total|Total of all reporting groups
11109457|NCT01640964|FG000|Participant Flow|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
11109458|NCT01640964|FG001|Participant Flow|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
11109459|NCT01640964|FG002|Participant Flow|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
11109460|NCT01640964|OG000|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
11109461|NCT01640964|OG000|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
11109462|NCT01640964|OG000|Outcome|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
11109463|NCT01640964|OG001|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
11109464|NCT01640964|EG000|Reported Event|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
11109465|NCT01640964|EG001|Reported Event|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
11109466|NCT01640964|EG002|Reported Event|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
11109467|NCT01641042|BG000|Baseline|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
11109468|NCT01641042|BG001|Baseline|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
11109469|NCT01641042|BG002|Baseline|Total|Total of all reporting groups
11109470|NCT01641042|FG000|Participant Flow|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
11109471|NCT01641042|FG001|Participant Flow|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
11109472|NCT01641042|OG000|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
11109473|NCT01641042|OG001|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
11109474|NCT01641042|EG000|Reported Event|Nimenrix At-risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
11109475|NCT01641042|EG001|Reported Event|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
11109476|NCT01641081|BG000|Baseline|Overall Study Population|All patients participating in the crossover study
11109477|NCT01641081|FG000|Participant Flow|Sequence 1|24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer; Placebo Pressair; Formoterol 12 μg Pressair; Formoterol 6 μg Pressair
11109478|NCT01641081|FG001|Participant Flow|Sequence 2|12 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Placebo Pressair
11109479|NCT01641081|FG002|Participant Flow|Sequence 3|Formoterol 12 μg Pressair; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Placebo Pressair; 24 μg Foradil Aerolizer
11109480|NCT01641081|FG003|Participant Flow|Sequence 4|Formoterol 6 μg Pressair; Placebo Pressair; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer
11109481|NCT01641081|FG004|Participant Flow|Sequence 5|Placebo Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 12 μg Pressair
11109482|NCT01641081|FG005|Participant Flow|Sequence 6|Formoterol 6 μg Pressair; Formoterol 12 μg Pressair; Placebo Pressair; 12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer
11109483|NCT01641081|FG006|Participant Flow|Sequence 7|Placebo Pressair; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer
11109484|NCT01641081|FG007|Participant Flow|Sequence 8|24 μg Foradil Aerolizer; Placebo Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Formoterol 12 μg Pressair
11109485|NCT01641081|FG008|Participant Flow|Sequence 9|12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; Placebo Pressair; Formoterol 6 μg Pressair
11109486|NCT01641081|FG009|Participant Flow|Sequence 10|Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Placebo Pressair
11109487|NCT01641081|OG000|Outcome|Foradil 24 μg|Administered via Aerolizer
11109488|NCT01641081|OG001|Outcome|Foradil 12 μg|Administered via Aerolizer
11109489|NCT01641081|OG002|Outcome|Formoterol 12 μg|Administered via Pressair
11109490|NCT01641081|OG003|Outcome|Formoterol 6 μg|Administered via Pressair
11109491|NCT01641081|OG004|Outcome|Placebo|Administered via Pressair
11109492|NCT01641081|EG000|Reported Event|Foradil 24 μg|Administered via Aerolizer
11109493|NCT01641081|EG001|Reported Event|Foradil 12 μg|Administered via Aerolizer
11109494|NCT01641081|EG002|Reported Event|Formoterol 12 μg|Administered via Pressair
11109495|NCT01641081|EG003|Reported Event|Formoterol 6 μg|Administered via Pressair
11109496|NCT01641081|EG004|Reported Event|Placebo|Administered via Pressair
11109497|NCT01641120|BG000|Baseline|All Study Participants|Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle
11109498|NCT01641120|FG000|Participant Flow|25 Gauge or 30 Gauge Needle|Avonex: Intramuscular injection administered using 25 gauge needle weeks 1, 4, and 5 and 30 gauge needle on weeks 2 and 3.
11109499|NCT01641120|OG000|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
11109500|NCT01641120|OG001|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
11109501|NCT01641120|OG001|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
11109502|NCT01641120|EG000|Reported Event|25 Gauge|The same subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
11109503|NCT01641120|EG001|Reported Event|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
11109504|NCT01641133|BG000|Baseline|Synflorix Group|Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
11109505|NCT01641133|BG001|Baseline|Prevnar 1 Group|Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
11109506|NCT01641133|BG002|Baseline|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
11109507|NCT01641133|BG003|Baseline|Total|Total of all reporting groups
11109508|NCT01641133|FG000|Participant Flow|Synflorix Group|Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
11109509|NCT01641133|FG001|Participant Flow|Prevnar 1 Group|Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
11109510|NCT01641133|FG002|Participant Flow|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
11109511|NCT01641133|OG000|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
11109512|NCT01641133|OG001|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
11109513|NCT01641133|OG002|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
11109514|NCT01641133|EG000|Reported Event|Synflorix Group|Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
11109515|NCT01641133|EG001|Reported Event|Prevnar 1 Group|Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
11109516|NCT01641133|EG002|Reported Event|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
11109517|NCT01641159|BG000|Baseline|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
11109518|NCT01641159|BG001|Baseline|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
11109519|NCT01641159|BG002|Baseline|Total|Total of all reporting groups
11109520|NCT01641159|FG000|Participant Flow|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
11109521|NCT01641159|FG001|Participant Flow|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
11109522|NCT01641159|OG000|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
11109523|NCT01641159|OG001|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
11109524|NCT01641159|EG000|Reported Event|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
11109525|NCT01641159|EG001|Reported Event|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
11109526|NCT01641198|BG000|Baseline|Configuration 1|Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3
11109527|NCT01641198|BG001|Baseline|Configuration 2|Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4
11109528|NCT01641198|BG002|Baseline|Configuration 3|Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
11109529|NCT01641198|BG003|Baseline|Total|Total of all reporting groups
11109530|NCT01641198|FG000|Participant Flow|Configuration 1|Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3
11109531|NCT01641198|FG001|Participant Flow|Configuration 2|Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4
11109532|NCT01641198|FG002|Participant Flow|Configuration 3|Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
11109533|NCT01641198|OG000|Outcome|Configuration 1|Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3
11109534|NCT01641198|OG001|Outcome|Configuration 2|Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4
11109535|NCT01641198|OG002|Outcome|Configuration 3|Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
11109536|NCT01641198|OG002|Outcome|Configuration 3|Surgical placement of devices (implants): B at sites1 and 4, SW at site 3, SC at sites 2 and 5
11109537|NCT01641198|EG000|Reported Event|Configuration 1|Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3
11109538|NCT01641198|EG001|Reported Event|Configuration 2|Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4
11109539|NCT01641198|EG002|Reported Event|Configuration 3|Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
11109540|NCT01641237|BG000|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments.
11109541|NCT01641237|FG000|Participant Flow|Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
11109542|NCT01641237|FG001|Participant Flow|NaF Dentifrice (1150ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
11109543|NCT01641237|FG002|Participant Flow|NaF Dentifrice (250ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
11109544|NCT01641237|FG003|Participant Flow|Placebo Dentifrice (0ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
11109545|NCT01641237|OG000|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
11109546|NCT01641237|OG001|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
11109547|NCT01641237|OG002|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
11109548|NCT01641237|OG003|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
11109549|NCT01641237|EG000|Reported Event|NaF Dentifrice (1426 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated.
11109550|NCT01641237|EG001|Reported Event|NaF Dentifrice (1150 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated.
11109551|NCT01641237|EG002|Reported Event|NaF Dentifrice (250 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated.
11109552|NCT01641237|EG003|Reported Event|Placebo Dentifrice (0 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated.
11109553|NCT01641367|BG000|Baseline|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
11109554|NCT01641367|BG001|Baseline|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
11109555|NCT01641367|BG002|Baseline|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
11109556|NCT01641367|BG003|Baseline|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
11109557|NCT01641367|BG004|Baseline|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
11109558|NCT01641367|BG005|Baseline|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
11109559|NCT01641367|BG006|Baseline|Total|Total of all reporting groups
11109560|NCT01641367|FG000|Participant Flow|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
11109561|NCT01641367|FG001|Participant Flow|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
11109562|NCT01641367|FG002|Participant Flow|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
11109563|NCT01641367|FG003|Participant Flow|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
11109564|NCT01641367|FG004|Participant Flow|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
11109565|NCT01641367|FG005|Participant Flow|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
11109566|NCT01641367|FG006|Participant Flow|Cell Phone Intervention (CPI) + Standard of Care (SOC)|"The CPI was a simple interactive system (Short Message Service [SMS] Reminder and Flashback System) to identify non-adherence soon after it occurred and, in response, a site-based culturally relevant algorithm for managing barriers to adherence. Reminders were sent daily for the first 8 weeks on study, then three times per week for the next 8 weeks, and then weekly through to 48 weeks after study entry. Participants were expected to respond (flashback) to each reminder. Failure to respond, triggered the system to alert the site to contact the participant. Sites were instructed to contact the participant if they missed any three flashbacks over two weeks during the daily messaging period, any two missed flashbacks over two weeks of the three times a week messaging period, and any two missed flashbacks over two weeks during the weekly messaging period. Additionally, sites were instructed to continue the local standard of care practices for managing adherence barriers."
11109567|NCT01641367|FG007|Participant Flow|Standard of Care (SOC)|Sites were instructed to continue the local standard of care practices for managing adherence barriers.
11109568|NCT01641367|OG000|Outcome|Overall Study|Entire enrolled population spanning all arms and interventions.
11109569|NCT01641367|OG001|Outcome|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
11109570|NCT01641367|OG002|Outcome|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
11109571|NCT01641367|OG003|Outcome|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
11109572|NCT01641367|OG004|Outcome|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
11109573|NCT01641367|OG005|Outcome|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
11109574|NCT01641367|OG006|Outcome|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
11109575|NCT01641367|OG000|Outcome|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
11109576|NCT01641367|OG001|Outcome|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
11348285|NCT04189081|BG002|Baseline|Positive Control|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11109577|NCT01641367|OG002|Outcome|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
11109578|NCT01641367|OG003|Outcome|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
11109579|NCT01641367|OG004|Outcome|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
11109580|NCT01641367|OG005|Outcome|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
11109581|NCT01641367|OG000|Outcome|Cell Phone Intervention (CPI) + Standard of Care (SOC)|"The CPI was a simple interactive system (Short Message Service [SMS] Reminder and Flashback System) to identify non-adherence soon after it occurred and, in response, a site-based culturally relevant algorithm for managing barriers to adherence. Reminders were sent daily for the first 8 weeks on study, then three times per week for the next 8 weeks, and then weekly through to 48 weeks after study entry. Participants were expected to respond (flashback) to each reminder. Failure to respond, triggered the system to alert the site to contact the participant. Sites were instructed to contact the participant if they missed any three flashbacks over two weeks during the daily messaging period, any two missed flashbacks over two weeks of the three times a week messaging period, and any two missed flashbacks over two weeks during the weekly messaging period. Additionally, sites were instructed to continue the local standard of care practices for managing adherence barriers."
11109582|NCT01641367|OG001|Outcome|Standard of Care (SOC)|Sites were instructed to continue the local standard of care practices for managing adherence barriers.
11109583|NCT01641367|EG000|Reported Event|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
11109584|NCT01641367|EG001|Reported Event|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
11109585|NCT01641367|EG002|Reported Event|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
11109586|NCT01641367|EG003|Reported Event|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
11109587|NCT01641367|EG004|Reported Event|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
11109588|NCT01641367|EG005|Reported Event|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
11348286|NCT04189081|BG003|Baseline|Total|Total of all reporting groups
11109589|NCT01641380|BG000|Baseline|Intervention|"Youth assigned to the DepoText intervention arm also received a welcome text message, daily text appointment reminders using the Compliance for Life (CFL) ™ short messaging system (SMS) platform starting 72 hours before the clinical visit with the option to cease messages by responding (yes or no) with their plans to attend the visit. If the patient responded no to appointment reminders, then an email was automatically sent to the nurse case manager who contacted the patient to reschedule the appointment. Intervention adolescents also received prescheduled health messages regarding condom use for STI prevention, healthy weight management, encouragement to call the nurse for problems, and an STI screening reminder."
11109590|NCT01641380|BG001|Baseline|Control|Standard of care
11109591|NCT01641380|BG002|Baseline|Total|Total of all reporting groups
11109592|NCT01641380|FG000|Participant Flow|Control|Adolescents in the Control Arm received standard of care. They continue to receive the DepoProvera injections through scheduled appointment, but would not receive a call from the nurse case manager regarding DepoProvera appointments until they have missed their scheduled DepoProvera appointment.
11109593|NCT01641380|FG001|Participant Flow|Text Messaging Intervention|"Adolescents in the intervention arm receive text message reminders for appointments and positive sexual health messages regarding use of DepoProvera in between scheduled appointments. They are encouraged to seek care for assistance with obtaining condoms and/or if they are having problems with the medication.~Text Messaging Intervention:~Online enrollment in the Compliance for Life® (CFL) system through iReminder)~Welcome Message 24 hrs after enrollment~Appointment Reminder prior to 3 month injection cycles~Monthly health reminders i. Condom use ii. Weight control iii. Side Effect Management 5.6-month STD testing reminder~6.Call for missed appointment or no reply to appointment reminder (or other text message)"
11109594|NCT01641380|OG000|Outcome|Intervention|"Youth assigned to the DepoText intervention arm also received a welcome text message, daily text appointment reminders using the Compliance for Life (CFL) ™ short messaging system (SMS) platform starting 72 hours before the clinical visit with the option to cease messages by responding (yes or no) with their plans to attend the visit. If the patient responded no to appointment reminders, then an email was automatically sent to the nurse case manager who contacted the patient to reschedule the appointment. Intervention adolescents also received prescheduled health messages regarding condom use for STI prevention, healthy weight management, encouragement to call the nurse for problems, and an STI screening reminder."
11109595|NCT01641380|OG001|Outcome|Control|Standard of care
11109596|NCT01641380|OG000|Outcome|Eligible Participants|Eligible participants among those approached for participation.
11109597|NCT01641380|EG000|Reported Event|Control|Adolescents in the Control Arm received standard of care. They continue to receive the DepoProvera injections through scheduled appointment, but would not receive a call from the nurse case manager regarding DepoProvera appointments until they have missed their scheduled DepoProvera appointment.
11109598|NCT01641380|EG001|Reported Event|Text Messaging Intervention|"Adolescents in the intervention arm receive text message reminders for appointments and positive sexual health messages regarding use of DepoProvera in between scheduled appointments. They are encouraged to seek care for assistance with obtaining condoms and/or if they are having problems with the medication.~Text Messaging Intervention:~Online enrollment in the Compliance for Life® (CFL) system through iReminder)~Welcome Message 24 hrs after enrollment~Appointment Reminder prior to 3 month injection cycles~Monthly health reminders i. Condom use ii. Weight control iii. Side Effect Management 5.6-month STD testing reminder~6.Call for missed appointment or no reply to appointment reminder (or other text message)"
11109599|NCT01641445|BG000|Baseline|Topiramate|Topiramate (200 mg) taken orally daily
11109600|NCT01641445|BG001|Baseline|Sugar Pill|"Placebo (sugar pill) taken orally daily"
11109601|NCT01641445|BG002|Baseline|Total|Total of all reporting groups
11109602|NCT01641445|FG000|Participant Flow|Topiramate|Topiramate (200 mg) taken orally daily
11109603|NCT01641445|FG001|Participant Flow|Sugar Pill|"Placebo (sugar pill) taken orally daily"
11109604|NCT01641445|OG000|Outcome|Topiramate|Topiramate (200 mg) taken orally daily
11109605|NCT01641445|OG001|Outcome|Sugar Pill|"Placebo (sugar pill) taken orally daily"
11109606|NCT01641445|EG000|Reported Event|Topiramate|Topiramate (200 mg) taken orally daily
11109607|NCT01641445|EG001|Reported Event|Sugar Pill|"Placebo (sugar pill) taken orally daily"
11109608|NCT01641471|BG000|Baseline|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
11109609|NCT01641471|BG001|Baseline|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
11109610|NCT01641471|BG002|Baseline|Total|Total of all reporting groups
11109611|NCT01641471|FG000|Participant Flow|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
11109612|NCT01641471|FG001|Participant Flow|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
11109613|NCT01641471|OG000|Outcome|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
11109614|NCT01641471|OG001|Outcome|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
11109615|NCT01641471|EG000|Reported Event|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
11109616|NCT01641471|EG001|Reported Event|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
11109617|NCT01641640|BG000|Baseline|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
11109618|NCT01641640|FG000|Participant Flow|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
11109619|NCT01641640|OG000|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
11109620|NCT01641640|EG000|Reported Event|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
11109621|NCT01641653|BG000|Baseline|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
11109622|NCT01641653|BG001|Baseline|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
11109623|NCT01641653|BG002|Baseline|Total|Total of all reporting groups
11109624|NCT01641653|FG000|Participant Flow|Placebo|"half of the patients will receive placebo (normal saline 2mL) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
11109625|NCT01641653|FG001|Participant Flow|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
11109626|NCT01641653|OG000|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
11109627|NCT01641653|OG001|Outcome|Midazolam|One half of subjects will recieveMidazolam: 1-2.5 mg IV
11109628|NCT01641653|OG001|Outcome|Midazolam|half of subjects will receive Midazolam: 1-2.5 mgIV prior to entering the OR
11109629|NCT01641653|OG000|Outcome|Placebo|subjects will receive 2cc. Normal Saline prior to entering the OR
11109630|NCT01641653|OG001|Outcome|Midazolam|subjects will receive midazolam 1.5-2mg prior to entering the OR
11109631|NCT01641653|EG000|Reported Event|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
11109632|NCT01641653|EG001|Reported Event|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
11109633|NCT01641692|BG000|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments :~UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo."
11109634|NCT01641692|FG000|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
11109635|NCT01641692|FG001|Participant Flow|UMEC 15.6 µg QD|Participants received umeclidinium bromide (UMEC) 15.6 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109636|NCT01641692|FG002|Participant Flow|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109637|NCT01641692|FG003|Participant Flow|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109638|NCT01641692|FG004|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109639|NCT01641692|FG005|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109640|NCT01641692|FG006|Participant Flow|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
11109641|NCT01641692|FG007|Participant Flow|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
11109642|NCT01641692|OG000|Outcome|All Study Treatments|The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments : UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo.
11109643|NCT01641692|OG000|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
11109644|NCT01641692|OG001|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109645|NCT01641692|OG002|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109646|NCT01641692|OG003|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109647|NCT01641692|OG004|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109648|NCT01641692|OG005|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109649|NCT01641692|OG006|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
11109650|NCT01641692|OG007|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
11109651|NCT01641692|EG000|Reported Event|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
11109652|NCT01641692|EG001|Reported Event|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109653|NCT01641692|EG002|Reported Event|UMEC 31.5 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109654|NCT01641692|EG003|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109655|NCT01641692|EG004|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109656|NCT01641692|EG005|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
11109657|NCT01641692|EG006|Reported Event|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
11109658|NCT01641692|EG007|Reported Event|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
11109659|NCT01641809|BG000|Baseline|GSK1265744 10 mg|Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109660|NCT01641809|BG001|Baseline|GSK1265744 30 mg|Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109661|NCT01641809|BG002|Baseline|GSK1265744 60 mg|Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109662|NCT01641809|BG003|Baseline|Efavirenz 600 mg|Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
11109663|NCT01641809|BG004|Baseline|Total|Total of all reporting groups
11109664|NCT01641809|FG000|Participant Flow|GSK1265744 10 mg|Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109665|NCT01641809|FG001|Participant Flow|GSK1265744 30 mg|Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109666|NCT01641809|FG002|Participant Flow|GSK1265744 60 mg|Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109667|NCT01641809|FG003|Participant Flow|Efavirenz 600 mg|Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
11109668|NCT01641809|OG000|Outcome|GSK1265744 10 mg|Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109669|NCT01641809|OG001|Outcome|GSK1265744 30 mg|Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109670|NCT01641809|OG002|Outcome|GSK1265744 60 mg|Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
11109671|NCT01641809|OG003|Outcome|Efavirenz 600 mg|Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
11109672|NCT01641809|EG000|Reported Event|GSK1265744 10 mg (Induction Phase)|Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.
11109673|NCT01641809|EG001|Reported Event|GSK1265744 30 mg (Induction Phase)|Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.
11109674|NCT01641809|EG002|Reported Event|GSK1265744 60 mg (Induction Phase)|Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.
11109675|NCT01641809|EG003|Reported Event|Efavirenz 600 mg (Induction Phase)|Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.
11109676|NCT01641809|EG004|Reported Event|GSK1265744 10 mg (Maintenance Phase)|Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.
11109677|NCT01641809|EG005|Reported Event|GSK1265744 30 mg (Maintenance Phase)|Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.
11109678|NCT01641809|EG006|Reported Event|GSK1265744 60 mg (Maintenance Phase)|Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.
11109679|NCT01641809|EG007|Reported Event|Efavirenz 600 mg (Maintenance Phase)|Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily.
11109680|NCT01641809|EG008|Reported Event|GSK1265744 10 mg (Open-label Phase)|Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.
11109681|NCT01641809|EG009|Reported Event|GSK1265744 30 mg (Open-label Phase)|Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.
11109682|NCT01641809|EG010|Reported Event|GSK1265744 60 mg (Open-label Phase)|Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.
11109683|NCT01641809|EG011|Reported Event|Efavirenz 600mg (Open-label Phase)|Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
11109684|NCT01641822|BG000|Baseline|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
11109685|NCT01641822|BG001|Baseline|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
11109686|NCT01641822|BG002|Baseline|Total|Total of all reporting groups
11109687|NCT01641822|FG000|Participant Flow|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
11109688|NCT01641822|FG001|Participant Flow|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
11109689|NCT01641822|FG002|Participant Flow|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
11109690|NCT01641822|OG000|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
11109691|NCT01641822|OG001|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
11109692|NCT01641822|EG000|Reported Event|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
11109693|NCT01641822|EG001|Reported Event|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
11109694|NCT01641822|EG002|Reported Event|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
11109695|NCT01641835|BG000|Baseline|Normals|No eye disease.
11109696|NCT01641835|FG000|Participant Flow|Normals|No eye disease.
11109697|NCT01641835|OG000|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
11109698|NCT01641835|EG000|Reported Event|Normals|No adverse events were reported.
11109699|NCT01641861|BG000|Baseline|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
11109700|NCT01641861|BG001|Baseline|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
11109701|NCT01641861|BG002|Baseline|Total|Total of all reporting groups
11109702|NCT01641861|FG000|Participant Flow|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
11109703|NCT01641861|FG001|Participant Flow|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
11109704|NCT01641861|OG000|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
11109705|NCT01641861|OG001|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
11109706|NCT01641861|EG000|Reported Event|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
11109707|NCT01641861|EG001|Reported Event|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
11109708|NCT01641900|BG000|Baseline|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
11109709|NCT01641900|BG001|Baseline|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
11109710|NCT01641900|BG002|Baseline|Total|Total of all reporting groups
11109711|NCT01641900|FG000|Participant Flow|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
11109712|NCT01641900|FG001|Participant Flow|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
11109713|NCT01641900|OG000|Outcome|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
11109714|NCT01641900|OG001|Outcome|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
11109715|NCT01641900|EG000|Reported Event|Placebo With Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Placebo Intervention.
11109716|NCT01641900|EG001|Reported Event|Placebo Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Placebo Intervention.
11109717|NCT01641900|EG002|Reported Event|3mg Eszopiclone With Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Drug Intervention.
11109718|NCT01641900|EG003|Reported Event|3mg Eszopiclone Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Drug Intervention.
11109719|NCT01641926|BG000|Baseline|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
11109720|NCT01641926|BG001|Baseline|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
11109721|NCT01641926|BG002|Baseline|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
11109722|NCT01641926|BG003|Baseline|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
11109723|NCT01641926|BG004|Baseline|Total|Total of all reporting groups
11109724|NCT01641926|FG000|Participant Flow|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
11109725|NCT01641926|FG001|Participant Flow|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
11109726|NCT01641926|FG002|Participant Flow|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
11109727|NCT01641926|FG003|Participant Flow|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
11109728|NCT01641926|OG000|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
11109729|NCT01641926|OG001|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
11109730|NCT01641926|OG002|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
11109731|NCT01641926|OG003|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
11109732|NCT01641926|EG000|Reported Event|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
11109733|NCT01641926|EG001|Reported Event|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
11109734|NCT01641926|EG002|Reported Event|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
11109735|NCT01641926|EG003|Reported Event|HBeAG(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
11109736|NCT01641939|BG000|Baseline|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109737|NCT01641939|BG001|Baseline|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109738|NCT01641939|BG002|Baseline|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109739|NCT01641939|BG003|Baseline|Total|Total of all reporting groups
11109740|NCT01641939|FG000|Participant Flow|Standard Taxane Therapy|Docetaxel was administered at 75 milligram per meter square (mg/m^2) intravenously (IV) on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109741|NCT01641939|FG001|Participant Flow|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109742|NCT01641939|FG002|Participant Flow|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109743|NCT01641939|OG000|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109744|NCT01641939|OG001|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109745|NCT01641939|OG001|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109746|NCT01641939|OG002|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109747|NCT01641939|OG000|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109748|NCT01641939|EG000|Reported Event|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109749|NCT01641939|EG001|Reported Event|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109750|NCT01641939|EG002|Reported Event|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
11109751|NCT01641952|BG000|Baseline|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
11109752|NCT01641952|FG000|Participant Flow|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
11109753|NCT01641952|OG000|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
11109754|NCT01641952|EG000|Reported Event|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
11109755|NCT01641978|BG000|Baseline|Neurologic Level|Neurologic patients
11109756|NCT01641978|FG000|Participant Flow|Neurologic Level|Neurologic patients
11109757|NCT01641978|OG000|Outcome|Neurologic Level|Neurologic patients
11109758|NCT01641978|OG000|Outcome|Severe|patients with GCS < 9 points
11109759|NCT01641978|OG001|Outcome|Moderate|patients with GCS 9 - 12 points
10846836|NCT00280241|FG000|Participant Flow|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
11109760|NCT01641978|OG002|Outcome|Slight|patients with GCS > 12 points
11109761|NCT01641978|OG000|Outcome|Critical Care Time Experience|Influence of work experience in the evaluation of neurological patients
11109762|NCT01641978|EG000|Reported Event|Neurologic Level|Neurologic patients
11109763|NCT01641991|BG000|Baseline|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
11109764|NCT01641991|BG001|Baseline|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109765|NCT01641991|BG002|Baseline|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109766|NCT01641991|BG003|Baseline|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109767|NCT01641991|BG004|Baseline|Total|Total of all reporting groups
11109768|NCT01641991|FG000|Participant Flow|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
11109769|NCT01641991|FG001|Participant Flow|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109770|NCT01641991|FG002|Participant Flow|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109771|NCT01641991|FG003|Participant Flow|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109772|NCT01641991|OG000|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
11109773|NCT01641991|OG001|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109774|NCT01641991|OG002|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109775|NCT01641991|OG003|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109776|NCT01641991|OG001|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109777|NCT01641991|OG002|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109778|NCT01641991|OG000|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109779|NCT01641991|EG000|Reported Event|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
11109780|NCT01641991|EG001|Reported Event|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109781|NCT01641991|EG002|Reported Event|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109782|NCT01641991|EG003|Reported Event|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
11109783|NCT01642056|BG000|Baseline|EPI-743, Then Placebo|Received EPI-743, 15mg/kg up to a maximum dose of 200 mg orally or via gastric tube three times daily with meals, then placebo three times daily orally or via gastric tube with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant.
11109784|NCT01642056|BG001|Baseline|Placebo, Then EPI-743|Received Placebo three times daily orally or via gastric tube with meals, then EPI-743, 15mg/kg up to a maximum dose of 200 mg three times daily orally or via gastric tube with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant.
11109785|NCT01642056|BG002|Baseline|Total|Total of all reporting groups
11109786|NCT01642056|FG000|Participant Flow|EPI-743, Then Placebo|Received EPI-743, 15mg/kg up to a maximum dose of 200 mg orally or via gastric tube three times daily with meals, then placebo three times daily orally or via gastric tube with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant.
11109787|NCT01642056|FG001|Participant Flow|Placebo, Then EPI-743|Received Placebo three times daily orally or via gastric tube with meals, then EPI-743, 15mg/kg up to a maximum dose of 200 mg three times daily orally or via gastric tube with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant.
11109788|NCT01642056|OG000|Outcome|EPI-743, Then Placebo|Received EPI-743, 15mg/kg up to a maximum dose of 200 mg orally or via gastric tube three times daily with meals, then placebo three times daily orally or via gastric tube with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant.
11109789|NCT01642056|OG001|Outcome|Placebo, Then EPI-743|Received Placebo three times daily orally or via gastric tube with meals, then EPI-743, 15mg/kg up to a maximum dose of 200 mg three times daily orally or via gastric tube with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant.
11109790|NCT01642056|EG000|Reported Event|EPI-743|Received EPI-743, 15mg/kg up to a maximum dose of 200 mg orally or via gastric tube three times daily with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant.
11109791|NCT01642056|EG001|Reported Event|Placebo|Received Placebo three times daily orally or via gastric tube with meals.
11109792|NCT01642082|BG000|Baseline|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Dalantercept: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11109793|NCT01642082|FG000|Participant Flow|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
11109794|NCT01642082|OG000|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
11109795|NCT01642082|OG000|Outcome|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Dalantercept: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11109796|NCT01642082|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
11109797|NCT01642082|OG001|Outcome|Grade 1 (CTCAE v4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
11109798|NCT01642082|OG002|Outcome|Grade 2 (CTCAE v4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
11109799|NCT01642082|OG003|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology version 4.0
11109800|NCT01642082|OG004|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
11109801|NCT01642082|OG005|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
11109802|NCT01642082|EG000|Reported Event|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
11109803|NCT01642147|BG000|Baseline|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
11109804|NCT01642147|BG001|Baseline|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
11109805|NCT01642147|BG002|Baseline|Total|Total of all reporting groups
11109806|NCT01642147|FG000|Participant Flow|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
11109807|NCT01642147|FG001|Participant Flow|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
11109808|NCT01642147|OG000|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
11109809|NCT01642147|OG001|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
11109810|NCT01642147|EG000|Reported Event|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
11109811|NCT01642147|EG001|Reported Event|Craniotomy Group|Randomly chosen patients undergoing selective craniotomy surgery. Transcranial Doppler measures,jugular venous bulb catheterization, radial artery catheterization, and craniotomy under general anesthesia will be performed.
11109812|NCT01642212|BG000|Baseline|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109813|NCT01642212|BG001|Baseline|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109814|NCT01642212|BG002|Baseline|Total|Total of all reporting groups
11109815|NCT01642212|FG000|Participant Flow|Single-blind Placebo|Eligible participants entered a 4-week, single-blind, placebo baseline period. Participants ingested the first dose of placebo in the clinic in the presence of study center personnel, and the remaining doses were ingested at home. Participants took placebo twice daily (bid); once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109816|NCT01642212|FG001|Participant Flow|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109817|NCT01642212|FG002|Participant Flow|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109818|NCT01642212|FG003|Participant Flow|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
11109819|NCT01642212|FG004|Participant Flow|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
11109820|NCT01642212|OG000|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109821|NCT01642212|OG001|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109822|NCT01642212|EG000|Reported Event|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109823|NCT01642212|EG001|Reported Event|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2mg OBS (formulation MB-9) 2 mg twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
11109824|NCT01642212|EG002|Reported Event|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
10846001|NCT00272168|FG001|Participant Flow|Arm 2: Control|"Supportive Treatment for Serious Mental Illness (control)~Supportive Treatment for Serious Mental Illness (SMI): Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
11109825|NCT01642212|EG003|Reported Event|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
11109826|NCT01642238|BG000|Baseline|Antithrombotic Effects|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) using a randomized, two-treatment, two-period, cross-over design in healthy volunteers.
11109827|NCT01642238|FG000|Participant Flow|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
11109828|NCT01642238|FG001|Participant Flow|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
11109829|NCT01642238|OG000|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
11109830|NCT01642238|OG001|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
11109831|NCT01642238|EG000|Reported Event|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
11109832|NCT01642238|EG001|Reported Event|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
11109833|NCT01642251|BG000|Baseline|Phase I|The phase I portion of the study was designed to determine the recommended dose for veliparib for the phase II portion of the trial. A total of 9 patients were treated on the phase I study. A total of 3 dose levels of veliparib were planned: 60mg (level 1), 100gm (level 2) and 40mg (level -1). 1 cycle=3 weeks, maximum of 4 cycles.
11109834|NCT01642251|BG001|Baseline|Phase II: Arm D (Veliparib)|"Patients receive veliparib PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Etoposide: Given IV~Veliparib: Given PO"
10878609|NCT00453362|OG000|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
10878610|NCT00453362|OG001|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
10878611|NCT00453362|OG000|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
10878612|NCT00453362|OG000|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
11109835|NCT01642251|BG002|Baseline|Phase II: Arm E (Placebo)|"Patients receive placebo PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Etoposide: Given IV~Placebo: placebo of Veliparib"
10878613|NCT00453362|OG001|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
10878614|NCT00453362|OG000|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
11109836|NCT01642251|BG003|Baseline|Total|Total of all reporting groups
11109837|NCT01642251|FG000|Participant Flow|Phase I: Arm A (Dose Level 1)|The phase I portion of the study was designed to determine the recommended dose for veliparib for the phase II portion of the trial. A total of 9 patients were treated on the phase I study. A total of 3 dose levels of veliparib were planned: 60mg (level 1), 100gm (level 2) and 40mg (level -1). 1 cycle=3 weeks, maximum of 4 cycles.
11109838|NCT01642251|FG001|Participant Flow|Phase I: Arm B (Dose Level II)|The phase I portion of the study was designed to determine the recommended dose for veliparib for the phase II portion of the trial. A total of 9 patients were treated on the phase I study. A total of 3 dose levels of veliparib were planned: 60mg (level 1), 100gm (level 2) and 40mg (level -1). 1 cycle=3 weeks, maximum of 4 cycles.
11109839|NCT01642251|FG002|Participant Flow|Phase II: Arm D (Veliparib)|"Patients receive veliparib PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Etoposide: Given IV~Veliparib: Given PO"
11109840|NCT01642251|FG003|Participant Flow|Phase II: Arm E (Placebo)|"Patients receive placebo PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Etoposide: Given IV~Placebo: placebo of Veliparib"
11109841|NCT01642251|OG000|Outcome|Phase I|The phase I portion of the study was designed to determine the recommended dose for veliparib for the phase II portion of the trial. A total of 9 patients were treated on the phase I study. A total of 3 dose levels of veliparib were planned: 60mg (level 1), 100gm (level 2) and 40mg (level -1). 1 cycle=3 weeks, maximum of 4 cycles.
11109842|NCT01642251|OG000|Outcome|Phase II: Arm D (Veliparib)|"Patients receive veliparib PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Etoposide: Given IV~Veliparib: Given PO"
11109843|NCT01642251|OG001|Outcome|Phase II: Arm E (Placebo)|"Patients receive placebo PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Etoposide: Given IV~Placebo: placebo of Veliparib"
11109844|NCT01642251|EG000|Reported Event|Phase I: Arm A (Dose Level 1)|The phase I portion of the study was designed to determine the recommended dose for veliparib for the phase II portion of the trial. A total of 9 patients were treated on the phase I study. A total of 3 dose levels of veliparib were planned: 60mg (level 1), 100gm (level 2) and 40mg (level -1). 1 cycle=3 weeks, maximum of 4 cycles.
11109845|NCT01642251|EG001|Reported Event|Phase I: Arm B (Dose Level 2)|The phase I portion of the study was designed to determine the recommended dose for veliparib for the phase II portion of the trial. A total of 9 patients were treated on the phase I study. A total of 3 dose levels of veliparib were planned: 60mg (level 1), 100gm (level 2) and 40mg (level -1). 1 cycle=3 weeks, maximum of 4 cycles.
11109846|NCT01642251|EG002|Reported Event|Phase II: Arm D (Veliparib)|"Patients receive veliparib PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV Etoposide: Given IV Veliparib: Given PO"
11109847|NCT01642251|EG003|Reported Event|Phase II: Arm E (Placebo)|"Patients receive placebo PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV Etoposide: Given IV Placebo: placebo of Veliparib"
11109848|NCT01642277|BG000|Baseline|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5mg daily solifenacin (with an option to increase to 10mg daily solifenacin at 4 weeks) for the treatment of urinary urge incontinence (UUI).
11109849|NCT01642277|BG001|Baseline|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
11109850|NCT01642277|BG002|Baseline|Total|Total of all reporting groups
11109851|NCT01642277|FG000|Participant Flow|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
11109852|NCT01642277|FG001|Participant Flow|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
11109853|NCT01642277|OG000|Outcome|Urinary Urge Incontinence|Women who received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
11109854|NCT01642277|OG000|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
11109855|NCT01642277|OG001|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
11109856|NCT01642277|EG000|Reported Event|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
11109857|NCT01642277|EG001|Reported Event|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
11109858|NCT01642407|BG000|Baseline|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Weeks 4, 8, and 16 in Part 1 of the study. Participants who completed Part 1 and required continuing treatment with Sildenafil, received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Weeks 28, 40, 52 and thereafter every 12 weeks until Sildenafil obtained marketing approval (up to a maximum of 119.6 weeks). Participants with <= 20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with > 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
11348287|NCT04189081|FG000|Participant Flow|Water Control|"Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~Water Control: negative control"
11109859|NCT01642407|FG000|Participant Flow|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Weeks 4, 8, and 16 in Part 1 of the study. Participants who completed Part 1 and required continuing treatment with Sildenafil, received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Weeks 28, 40, 52 and thereafter every 12 weeks until Sildenafil obtained marketing approval (up to a maximum of 119.6 weeks). Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
11109860|NCT01642407|OG000|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Weeks 4, 8, and 16 in Part 1 of the study. Participants who completed Part 1 and required continuing treatment with Sildenafil, received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Weeks 28, 40, 52 and thereafter every 12 weeks until Sildenafil obtained marketing approval (up to a maximum of 119.6 weeks). Participants with <= 20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with > 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
11109861|NCT01642407|EG000|Reported Event|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Weeks 4, 8, and 16 in Part 1 of the study. Participants who completed Part 1 and required continuing treatment with Sildenafil, received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Weeks 28, 40, 52 and thereafter every 12 weeks until Sildenafil obtained marketing approval (up to a maximum of 119.6 weeks). Participants with <= 20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with > 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
11109862|NCT01642485|BG000|Baseline|All Study Participants|Subjects participating in the study attended for screening, two treatment periods (periods 1 and 2) of 4 assessment days each and a follow-up visit. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day -1) and treatment days (days 1-3). Moxifloxacin was given in fasted condition or with Continental breakfast, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. No wash-out was required between the other treatments investigated. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
11109863|NCT01642485|FG000|Participant Flow|Sequence 1|"Period1:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
11109864|NCT01642485|FG001|Participant Flow|Sequence 2|"Period1:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
11109865|NCT01642485|FG002|Participant Flow|Sequence 3|"Period1:~Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
11109866|NCT01642485|FG003|Participant Flow|Sequence 4|"Period1:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
11109867|NCT01642485|FG004|Participant Flow|Sequence 5|"Period1:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fasted"
11109868|NCT01642485|FG005|Participant Flow|Sequence 6|"Period1:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fasted"
11109869|NCT01642485|FG006|Participant Flow|Sequence 7|"Period1:~Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fasted"
11109870|NCT01642485|FG007|Participant Flow|Sequence 8|"Period1:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fasted"
11109871|NCT01642485|OG000|Outcome|Fasted Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fasted conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day -1) and treatment days (days 1-3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
11109872|NCT01642485|OG001|Outcome|Fed Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fed conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day -1) and treatment days (days 1-3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
11109873|NCT01642485|OG000|Outcome|FDA Breakfast|FDA breakfast: Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.
11109874|NCT01642485|OG001|Outcome|Continental Breakfast|"Continental breakfast: High carbohydrate breakfast (>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.~QTcF change from a baseline presented."
11109875|NCT01642485|OG002|Outcome|Placebo at Baseline|a baseline QTcF measured on Day -1 of each period
11109876|NCT01642485|OG000|Outcome|Moxifloxacin 400 mg Fasted|The highest change was at 2.5h time point, which is presented here.
11109877|NCT01642485|OG001|Outcome|Placebo|Time matched absolute value for QTcF for placebo treatment.
11109878|NCT01642485|OG000|Outcome|Insulin Clamp|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
11109879|NCT01642485|OG001|Outcome|Glucose|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
11109880|NCT01642485|OG002|Outcome|C-peptide|A euglycaemic/hyperinsulinaemic clamp involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous glucose and insulin production, and as a result reducing the release of C-peptides. This technique will firstly test whether hyperinsulinaemia has an effect on QT interval, and secondly whether C-peptide levels play any role in the proposed effect on the QT interval.
11109881|NCT01642485|OG000|Outcome|Caucasian Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (1h)
11109882|NCT01642485|OG001|Outcome|Caucasian Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
11109883|NCT01642485|OG002|Outcome|Japanese Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
11109884|NCT01642485|OG003|Outcome|Japanese Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
11109885|NCT01642485|EG000|Reported Event|Moxifloxacin 400 mg Fasted|"Moxifloxacin fasted: One single dose of 400mg moxifloxacin after fasting - This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies.~No significant other Adverse Events have been reported."
11109886|NCT01642485|EG001|Reported Event|Moxifloxacin 400 mg Fed|"Moxifloxacin with food: Currently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.~No significant other Adverse Events have been reported."
11109887|NCT01642589|BG000|Baseline|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
11109888|NCT01642589|BG001|Baseline|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
11109889|NCT01642589|BG002|Baseline|Total|Total of all reporting groups
11109890|NCT01642589|FG000|Participant Flow|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
11109891|NCT01642589|FG001|Participant Flow|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
11109892|NCT01642589|OG000|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
11109893|NCT01642589|OG001|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
11109894|NCT01642589|EG000|Reported Event|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
10846002|NCT00272168|OG000|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
11109895|NCT01642589|EG001|Reported Event|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
11109896|NCT01642602|BG000|Baseline|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
11109897|NCT01642602|FG000|Participant Flow|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
11109898|NCT01642602|OG000|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
11109899|NCT01642602|EG000|Reported Event|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
11109900|NCT01642615|BG000|Baseline|All Participants|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks in the Open Label Healing Phase. Participants with healing of EE were eligible to participate in the Maintenance Phase.
11109901|NCT01642615|FG000|Participant Flow|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
11109902|NCT01642615|FG001|Participant Flow|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
11109903|NCT01642615|FG002|Participant Flow|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
11109904|NCT01642615|OG000|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
11109905|NCT01642615|OG000|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
11109906|NCT01642615|OG001|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
11109907|NCT01642615|EG000|Reported Event|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
11109908|NCT01642615|EG001|Reported Event|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
11109909|NCT01642615|EG002|Reported Event|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
11109910|NCT01642914|BG000|Baseline|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109911|NCT01642914|BG001|Baseline|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109912|NCT01642914|BG002|Baseline|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109913|NCT01642914|BG003|Baseline|Total|Total of all reporting groups
11109914|NCT01642914|FG000|Participant Flow|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109915|NCT01642914|FG001|Participant Flow|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109916|NCT01642914|FG002|Participant Flow|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109917|NCT01642914|OG000|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109918|NCT01642914|OG001|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109919|NCT01642914|OG001|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109920|NCT01642914|OG002|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109921|NCT01642914|OG002|Outcome|Linaclotide 290 Micrograms|Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast
11109922|NCT01642914|EG000|Reported Event|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109923|NCT01642914|EG001|Reported Event|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109924|NCT01642914|EG002|Reported Event|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
11109925|NCT01643044|BG000|Baseline|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
11109926|NCT01643044|BG001|Baseline|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
11109927|NCT01643044|BG002|Baseline|Total|Total of all reporting groups
11109928|NCT01643044|FG000|Participant Flow|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
10879528|NCT00458341|EG001|Reported Event|Ataluren 10, 10, and 20 mg/kg|Participants received ataluren at 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment.
11109929|NCT01643044|FG001|Participant Flow|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
11109930|NCT01643044|OG000|Outcome|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
11109931|NCT01643044|OG001|Outcome|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
11109932|NCT01643044|EG000|Reported Event|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
11109933|NCT01643044|EG001|Reported Event|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
11126641|NCT01734655|OG000|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
11126642|NCT01734655|EG000|Reported Event|All Participants|Pregnant women who were overweight or obese and 18-40 yrs of age.
11126643|NCT01734746|BG000|Baseline|Sentinel Node Procedure|"Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.~blue dye and radioactive tracer"
11126644|NCT01734746|FG000|Participant Flow|Sentinel Node Procedure|"Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.~blue dye and radioactive tracer"
11126645|NCT01734746|OG000|Outcome|Sentinel Node Procedure|Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.
11126646|NCT01734746|OG000|Outcome|Sentinel Node Procedure|"Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.~blue dye and radioactive tracer"
11126647|NCT01734746|EG000|Reported Event|Sentinel Node Procedure|"Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.~blue dye and radioactive tracer"
11126648|NCT01734772|BG000|Baseline|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
11126649|NCT01734772|BG001|Baseline|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
11126650|NCT01734772|BG002|Baseline|Total|Total of all reporting groups
11126651|NCT01734772|FG000|Participant Flow|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
11126652|NCT01734772|FG001|Participant Flow|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
10846003|NCT00272168|OG001|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
11126653|NCT01734772|OG000|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
11109934|NCT01643213|BG000|Baseline|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
11109935|NCT01643213|BG001|Baseline|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
11109936|NCT01643213|BG002|Baseline|Total|Total of all reporting groups
11109937|NCT01643213|FG000|Participant Flow|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
11109938|NCT01643213|FG001|Participant Flow|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
11109939|NCT01643213|OG000|Outcome|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
11109940|NCT01643213|OG001|Outcome|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
11109941|NCT01643213|EG000|Reported Event|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
11109942|NCT01643213|EG001|Reported Event|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
11109943|NCT01643382|BG000|Baseline|Tight Glucose Control|"Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip.~Insulin: Insulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL"
11109944|NCT01643382|BG001|Baseline|Standard Glucose Control|"Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar.~Insulin, Asp(B28)-: Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level."
11109945|NCT01643382|BG002|Baseline|Total|Total of all reporting groups
11109946|NCT01643382|FG000|Participant Flow|Tight Glucose Control|"Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip.~Insulin: Insulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL"
11109947|NCT01643382|FG001|Participant Flow|Standard Glucose Control|"Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar.~Insulin, Asp(B28)-: Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level."
11109948|NCT01643382|OG000|Outcome|Tight Glucose Control|"Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip.~Insulin: Insulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL"
11109949|NCT01643382|OG001|Outcome|Standard Glucose Control|"Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar.~Insulin, Asp(B28)-: Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level."
11109950|NCT01643382|EG000|Reported Event|Tight Glucose Control|"Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip.~Insulin: Insulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL"
11109951|NCT01643382|EG001|Reported Event|Standard Glucose Control|"Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar.~Insulin, Asp(B28)-: Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level."
10846004|NCT00272168|EG000|Reported Event|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
11109952|NCT01643408|BG000|Baseline|Safety Population|All patients who received at least one dose of Erwinaze
11109953|NCT01643408|FG000|Participant Flow|Safety Population|All participants who received at least 1 dose of Erwinaze
11109954|NCT01643408|OG000|Outcome|Open-Label Erwinaze|asparaginase Erwinia chrysanthemi
11109955|NCT01643408|EG000|Reported Event|Safety Population|All participants who received at least 1 dose of Erwinaze
11109956|NCT01643473|BG000|Baseline|Attention Control|"Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes~Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes"
11109957|NCT01643473|BG001|Baseline|Tailored Adherence Intervention|"Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers~Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles."
11109958|NCT01643473|BG002|Baseline|Total|Total of all reporting groups
11109959|NCT01643473|FG000|Participant Flow|Attention Control|"Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes~Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes"
11109960|NCT01643473|FG001|Participant Flow|Tailored Adherence Intervention|"Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers~Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles."
11109961|NCT01643473|OG000|Outcome|Attention Control|"Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes~Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes"
11004939|NCT01078233|EG001|Reported Event|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
11004940|NCT01078233|EG002|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
11004941|NCT01078246|BG000|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
11004942|NCT01078246|BG001|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
11004943|NCT01078246|BG002|Baseline|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
11004944|NCT01078246|BG003|Baseline|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
11004945|NCT01078246|BG004|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
11004946|NCT01078246|BG005|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
11004947|NCT01078246|BG006|Baseline|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
11004948|NCT01078246|BG007|Baseline|Total|Total of all reporting groups
11004949|NCT01078246|FG000|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
11004950|NCT01078246|FG001|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
11004951|NCT01078246|FG002|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
11004952|NCT01078246|FG003|Participant Flow|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
11004953|NCT01078246|FG004|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
11004954|NCT01078246|FG005|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
11004955|NCT01078246|FG006|Participant Flow|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
11004956|NCT01078246|OG000|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
11004957|NCT01078246|OG001|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
11004958|NCT01078246|OG002|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
11004959|NCT01078246|EG000|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
11004960|NCT01078246|EG001|Reported Event|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
11109962|NCT01643473|OG001|Outcome|Tailored Adherence Intervention|"Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers~Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles."
11109963|NCT01643473|EG000|Reported Event|Attention Control|"Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes~Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes"
11109964|NCT01643473|EG001|Reported Event|Tailored Adherence Intervention|"Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers~Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles."
11109965|NCT01643616|BG000|Baseline|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
11109966|NCT01643616|BG001|Baseline|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
11109967|NCT01643616|BG002|Baseline|Total|Total of all reporting groups
11109968|NCT01643616|FG000|Participant Flow|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
11109969|NCT01643616|FG001|Participant Flow|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
11109970|NCT01643616|OG000|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
11109971|NCT01643616|OG001|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
11109972|NCT01643616|EG000|Reported Event|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
11109973|NCT01643616|EG001|Reported Event|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
11109974|NCT01643668|BG000|Baseline|BuClo RIC + SCT|"BuClo RIC SCT~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
11109975|NCT01643668|FG000|Participant Flow|BuClo RIC + SCT|"BuClo RIC SCT~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
11109976|NCT01643668|OG000|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
10879529|NCT00458393|BG000|Baseline|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
11109977|NCT01643668|EG000|Reported Event|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
11109978|NCT01643707|BG000|Baseline|Phase I|Phase I served as a control period during which physicians assessed and treated subjects per their site's standard care practice. Phase I of the study was to understand the current pathways at hospital for SND patient screening & management.
11109979|NCT01643707|BG001|Baseline|Phase II|In Phase II, investigators completed an educational workshop, were given access to the IMPROVE Brady toolkit and encouraged to adapt tools from this kit to create a practice-specific process improvement implementation. The toolkit included: a physician training seminar, a diagnostic algorithm, patient education materials, a list of available therapy options, and/or information regarding the benefits and risks associated with the therapy options.
11109980|NCT01643707|BG002|Baseline|Total|Total of all reporting groups
11109981|NCT01643707|FG000|Participant Flow|Phase I|Phase I served as a control period during which physicians assessed and treated subjects per their site's standard care practice.
11109982|NCT01643707|FG001|Participant Flow|Phase II|In Phase 2, investigators completed an educational workshop, were given access to the IMPROVE Brady toolkit and encouraged to adapt tools from this kit to create a practice-specific process improvement implementation.
11109983|NCT01643707|OG000|Outcome|Phase 1|Control subjects in the South Asia Region.
11109984|NCT01643707|OG001|Outcome|Phase 2|Treatment subjects in the South Asia Region
11109985|NCT01643707|OG000|Outcome|Phase 1|Control subjects in South Asia Region with an SND Diagnosis
11109986|NCT01643707|OG001|Outcome|Phase 2|Treatment subjects in South Asia Region with an SND Diagnosis
11109987|NCT01643707|OG000|Outcome|Phase 2 QoL Cohort|Subjects with QoL scores at implant and 6 Months
11109988|NCT01643707|EG000|Reported Event|Phase I|Characterize the current management of patients presenting with possible sinus node dysfunction
11109989|NCT01643707|EG001|Reported Event|Phase II|Assess the effect of critical care pathways, education and comprehensive disease state management on the adoption of ACC/AHA/HRS and ESC indications and therapies for sinus node dysfunction.
11109990|NCT01643772|BG000|Baseline|Oxycodone Hydrochloride Single Dose(5mg)|Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
11109991|NCT01643772|BG001|Baseline|Oxycodone Hydrochloride Single Dose(10mg)|Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
11109992|NCT01643772|BG002|Baseline|Oxycodone Hydrochloride Single Dose(20mg)|Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
11109993|NCT01643772|BG003|Baseline|Oxycodone Hydrochloride Multiple Dose(10mg)|Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
11109994|NCT01643772|BG004|Baseline|Total|Total of all reporting groups
11109995|NCT01643772|FG000|Participant Flow|Oxycodone Hydrochloride Single Dose(5mg)|Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
11109996|NCT01643772|FG001|Participant Flow|Oxycodone Hydrochloride Single Dose(10mg)|Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
11109997|NCT01643772|FG002|Participant Flow|Oxycodone Hydrochloride Single Dose(20mg)|Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
11109998|NCT01643772|FG003|Participant Flow|Oxycodone Hydrochloride Multiple Dose|Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
11109999|NCT01643772|OG000|Outcome|Oxycodone Hydrochloride Single Dose 5 mg|Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
11110000|NCT01643772|OG001|Outcome|Oxycodone Hydrochloride Single Dose 10 mg|Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
11110001|NCT01643772|OG002|Outcome|Oxycodone Hydrochloride Single Dose 20 mg|Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
11110002|NCT01643772|OG000|Outcome|Oxycodone Hydrochloride Multiple Dose|Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
11110003|NCT01643772|OG000|Outcome|Oxycodone Hydrochloride Multiple Dose 10 mg|Group 2: multiple dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
11110004|NCT01643772|OG000|Outcome|Oxycodone Hydrochloride Single Dose 10 mg|Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
11110005|NCT01643772|EG000|Reported Event|Oxycodone Hydrochloride Single Dose(5mg)|Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
11110006|NCT01643772|EG001|Reported Event|Oxycodone Hydrochloride Single Dose(10mg)|Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
11110007|NCT01643772|EG002|Reported Event|Oxycodone Hydrochloride Single Dose(20mg)|Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
11110008|NCT01643772|EG003|Reported Event|Oxycodone Hydrochloride Multiple Dose(10mg)|Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
11110009|NCT01643798|BG000|Baseline|Pretreatment & Stimulation|Outside of the 3T magnetic resonance imaging (MRI) scanner, participants underwent resting motor threshold assessment, left dorsolateral prefrontal cortex localization and preliminary pain testing. Next, participants were placed in the scanner for baseline pain testing. After baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive approximately 10 ml intravenous naloxone (0.1mg/kg) or saline immediately prior to 20 minutes of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20 minutes of real left DLPFC rTMS. Participants then returned to the scanner for the final block test.
11110010|NCT01643798|FG000|Participant Flow|Saline and Stimulation, Then Naloxone and Stimulation|Participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 0.1 mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
11110011|NCT01643798|FG001|Participant Flow|Naloxone and Stimulation, Then Saline and Stimulation|Participants received an intravenous infusion of 0.1mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
11110012|NCT01643798|OG000|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
11110013|NCT01643798|OG001|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
11126654|NCT01734772|OG001|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
11126655|NCT01734772|OG002|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
11110014|NCT01643798|OG002|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
11110015|NCT01643798|OG003|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
11110016|NCT01643798|OG000|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
11110017|NCT01643798|OG001|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
11110018|NCT01643798|OG002|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
11110019|NCT01643798|OG003|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
11110020|NCT01643798|EG000|Reported Event|Pretreatment & Stimulation|
11110021|NCT01643850|BG000|Baseline|MCS110 10 mg/kg (PART A)|Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
11110022|NCT01643850|BG001|Baseline|Placebo (PART A)|Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
11110023|NCT01643850|BG002|Baseline|MCS110 10 mg/kg (PART B)|Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
11110024|NCT01643850|BG003|Baseline|Placebo/10mg/kg (PART B)|Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110025|NCT01643850|BG004|Baseline|MCS110 3 mg/kg (Part C)|Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110026|NCT01643850|BG005|Baseline|MCS110 5 mg/kg (Part C)|Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11126656|NCT01734772|OG003|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
10848759|NCT00291343|OG001|Outcome|Tritanrix-HepB/Hiberix+Mencevax ACWY Group|Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
11110027|NCT01643850|BG006|Baseline|MCS110 10 mg/kg (Part C)|Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110028|NCT01643850|BG007|Baseline|MCS110 3 mg/kg & MCS110 10mg/kg (Part C)|Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
11110029|NCT01643850|BG008|Baseline|MCS110 5 mg/kg & MCS110 10mg/kg (PART C)|Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
11110030|NCT01643850|BG009|Baseline|Total|Total of all reporting groups
11110031|NCT01643850|FG000|Participant Flow|MCS110 10 mg/kg (PART A)|Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
11110032|NCT01643850|FG001|Participant Flow|Placebo (PART A)|Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
11110033|NCT01643850|FG002|Participant Flow|MCS110 10 mg/kg (PART B)|Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
11110034|NCT01643850|FG003|Participant Flow|Placebo/10mg/kg (PART B)|Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110035|NCT01643850|FG004|Participant Flow|MCS110 3 mg/kg (Part C)|Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110036|NCT01643850|FG005|Participant Flow|MCS110 5 mg/kg (Part C)|Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110037|NCT01643850|FG006|Participant Flow|MCS110 10 mg/kg (Part C)|Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110038|NCT01643850|FG007|Participant Flow|MCS110 3 mg/kg & MCS110 10mg/kg (Part C)|Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
11110039|NCT01643850|FG008|Participant Flow|MCS110 5 mg/kg & MCS110 10mg/kg (PART C)|Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
11110040|NCT01643850|OG000|Outcome|Placebo (PART ABC4)|Single dose placebo from PART A and B
11110041|NCT01643850|OG001|Outcome|MCS110 3 mg/kg (PART ABC4)|Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
11110042|NCT01643850|OG002|Outcome|MCS110 5 mg/kg (PART ABC4)|Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
11110043|NCT01643850|OG003|Outcome|MCS110 10 mg/kg (PART ABC4)|Single dose MCS110 10 mg/kg
11110044|NCT01643850|OG000|Outcome|MCS110 3 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 3 mg/kg
11110045|NCT01643850|OG001|Outcome|MCS110 5 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110046|NCT01643850|OG002|Outcome|MCS110 10 mg/kg (PART BC)|Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
11110047|NCT01643850|OG003|Outcome|MCS110 3 mg/kg & MCS110 10mg/kg (Part C)|Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
11110048|NCT01643850|OG004|Outcome|MCS110 5 mg/kg & MCS110 10mg/kg (Part C)|Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
11110049|NCT01643850|OG000|Outcome|MCS110 3 mg/kg (PART BC)|Participants received multiple monthly doses of MCS110 3 mg/kg
11110050|NCT01643850|OG001|Outcome|MCS110 5 mg/kg (PART BC)|Participants received multiple monthly doses of MCS110 5 mg/kg
11110051|NCT01643850|OG003|Outcome|MCS110 3 mg/kg & MCS110 10mg/kg (Part BC)|Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
11110052|NCT01643850|OG004|Outcome|MCS110 5 mg/kg & MCS110 10mg/kg (Part BC)|Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
11110053|NCT01643850|OG000|Outcome|MCS110 10 mg/kg (PART A)|Participants received a single dose of 10mg/kg on day 1 administered by i.v. infusion.
11110054|NCT01643850|OG001|Outcome|Placebo (PART A)|Participants received single dose placebo to match MCS110 10mg/kg (i.v. infusion)
11110055|NCT01643850|OG002|Outcome|MCS110 10 mg/kg (PART B)|Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
11110056|NCT01643850|OG003|Outcome|Placebo (PART B)|Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg. Subset of MCS110 (Part B)
11110057|NCT01643850|OG004|Outcome|MCS110 3 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 3 mg/kg
11110058|NCT01643850|OG005|Outcome|MCS110 5 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110059|NCT01643850|OG006|Outcome|MCS110 10 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
11110060|NCT01643850|OG000|Outcome|MCS110 10 mg/kg (PART A)|Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
11110061|NCT01643850|OG001|Outcome|MCS110 10 mg/kg (PART B)|Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
11110062|NCT01643850|OG002|Outcome|Placebo/10 mg kg (PART B)|Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
11110063|NCT01643850|OG003|Outcome|MCS110 3 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
11110064|NCT01643850|OG004|Outcome|MCS110 5 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110065|NCT01643850|OG005|Outcome|MCS110 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
11110066|NCT01643850|OG001|Outcome|Placebo/MCS110 10mg/kg (PART A)|Participants received single dose placebo to match MCS110 10 mg/k
11110067|NCT01643850|OG003|Outcome|Placebo/10 mg kg (PART B)|Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
11110068|NCT01643850|OG004|Outcome|MCS110 3 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
11110069|NCT01643850|OG006|Outcome|MCS110 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
11110070|NCT01643850|OG000|Outcome|MCS110 10 mg/kg (PART ABC4)|Participants received a single dose of MCS110 10 mg/kg
11110071|NCT01643850|OG001|Outcome|Placebo (PARTS A and B)|PART A: Participants received single dose placebo to match MCS110 10mg/kg (i.v. infusion). PART B: Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg.
11110072|NCT01643850|OG000|Outcome|MCS110 10 mg/kg (PART A)|Participants received a single dose of 10mg/kg on day 1 administered by regular infusion.
11110073|NCT01643850|OG001|Outcome|Placebo (PART A)|Participants received single dose placebo to match MCS110 10 mg/kg
11110074|NCT01643850|OG003|Outcome|Placebo (PART B)|Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg
10879530|NCT00458393|BG001|Baseline|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
11110075|NCT01643850|OG005|Outcome|MCS110 5 mg/kg (Part C)|Participants received multiple monthly doses of MCS110 5 mg/kg
11110076|NCT01643850|OG006|Outcome|MCS110 10 mg/kg (Part C)|Participants received multiple monthly doses of MCS110 10 mg/kg
11110077|NCT01643850|OG007|Outcome|MCS110 3 mg/kg & MCS110 10mg/kg (Part C)|Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
11110078|NCT01643850|OG008|Outcome|MCS110 5 mg/kg & MCS110 10mg/kg (PART C)|Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
11110079|NCT01643850|OG000|Outcome|MCS110 3 mg/kg (Part BC)|Participants received multiple monthly doses of MCS110 3 mg/kg
11110080|NCT01643850|OG001|Outcome|MCS110 5 mg/kg (Part BC)|Participants received multiple monthly doses of MCS110 5 mg/kg
11110081|NCT01643850|OG002|Outcome|MCS110 10 mg/kg (Part BC)|Participants received multiple monthly doses of MCS110 10 mg/kg
11110082|NCT01643850|OG003|Outcome|MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)|Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
11110083|NCT01643850|OG004|Outcome|MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)|Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
11110084|NCT01643850|OG003|Outcome|MCS110 3 mg/kg & MCS110 10 mg/kg (PART BC)|Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
11110085|NCT01643850|OG004|Outcome|MCS110 5 mg/kg & MCS110 10 mg/kg (PART BC)|Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
11110086|NCT01643850|OG000|Outcome|MCS110 10mg/kg (PART B)|Participants received multiple monthly doses of MCS110 10 mg/kg
11110087|NCT01643850|OG001|Outcome|MCS110 3 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 3 mg/kg
11110088|NCT01643850|OG002|Outcome|MCS110 5 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 5 mg/k. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110089|NCT01643850|OG003|Outcome|MCS110 10 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 10 mg/kg
11110090|NCT01643850|OG004|Outcome|MCS110 3/10 mg/kg (PART C)|Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses
11110091|NCT01643850|OG005|Outcome|MCS110 5/10 mg/kg (PART C)|Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
11110092|NCT01643850|OG002|Outcome|MCS110 3 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 5 mg/kg
11110093|NCT01643850|OG003|Outcome|MCS110 5 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 5 mg/k. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110094|NCT01643850|OG004|Outcome|MCS110 10 mg/kg (PART C)|Participants received multiple monthly doses of MCS110 10 mg/kg )
11110095|NCT01643850|OG005|Outcome|MCS110 3 mg/kg & MCS110 10mg/kg (PART C)|Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 3 mg/kg
11110096|NCT01643850|OG006|Outcome|MCS110 5 mg/kg & MCS110 10mg/kg (PART C)|Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
11110097|NCT01643850|EG000|Reported Event|MCS110 10 mg/kg (PART A)|Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
11110098|NCT01643850|EG001|Reported Event|Placebo (PART A)|Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
11110099|NCT01643850|EG002|Reported Event|MCS110 10mg/kg (PART B)|MCS110 10 mg/kg (i.v. infusion)
11110100|NCT01643850|EG003|Reported Event|Placebo/10mg/kg (PART B)|Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
11110101|NCT01643850|EG004|Reported Event|MCS110 3mg/kg (PART C)|MCS110 3 mg/kg (i.v. infusion)
11110102|NCT01643850|EG005|Reported Event|MCS110 5mg/kg (PART C)|MCS110 5 mg/kg (i.v. infusion)
11110103|NCT01643850|EG006|Reported Event|MCS110 10mg/kg (PART C)|MCS110 10 mg/kg (i.v. infusion)
11110104|NCT01643876|BG000|Baseline|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
11110105|NCT01643876|FG000|Participant Flow|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
11110106|NCT01643876|OG000|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
10879531|NCT00458393|BG002|Baseline|Total|Total of all reporting groups
11110107|NCT01643876|EG000|Reported Event|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
11110108|NCT01643902|BG000|Baseline|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
11110109|NCT01643902|FG000|Participant Flow|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~rt-PA: IV rt-PA 0.9 mg/kg minimum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target foor to needle time of 60 minutes or less from ED arrival."
11110110|NCT01643902|OG000|Outcome|IV Rt-PA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from Emergency department (ED) arrival."
11110111|NCT01643902|OG000|Outcome|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
11110112|NCT01643902|EG000|Reported Event|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
11110113|NCT01643928|BG000|Baseline|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
11110114|NCT01643928|BG001|Baseline|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
11126657|NCT01734772|OG004|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
11126658|NCT01734772|EG000|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
11110115|NCT01643928|BG002|Baseline|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
11110116|NCT01643928|BG003|Baseline|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
11110117|NCT01643928|BG004|Baseline|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
11110118|NCT01643928|BG005|Baseline|Total|Total of all reporting groups
11110119|NCT01643928|FG000|Participant Flow|PF-05280586/PF-05280586/PF-05280586|This group received intravenous (IV) rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
11110120|NCT01643928|FG001|Participant Flow|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
11110121|NCT01643928|FG002|Participant Flow|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
11110122|NCT01643928|FG003|Participant Flow|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
11110123|NCT01643928|FG004|Participant Flow|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
11110124|NCT01643928|OG000|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
11110125|NCT01643928|OG001|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
11110126|NCT01643928|OG002|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
11110127|NCT01643928|OG003|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
11110128|NCT01643928|OG004|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
11110129|NCT01643928|OG005|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
11110130|NCT01643928|OG006|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
11110131|NCT01643928|OG003|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
11110132|NCT01643928|OG004|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
11110133|NCT01643928|OG000|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110134|NCT01643928|OG001|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110135|NCT01643928|OG002|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110136|NCT01643928|OG003|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11110137|NCT01643928|OG004|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110138|NCT01643928|OG000|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11126659|NCT01734772|EG001|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
11126660|NCT01734772|EG002|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg once on day 4.
11110139|NCT01643928|OG001|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110140|NCT01643928|OG002|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110141|NCT01643928|OG003|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11110142|NCT01643928|OG004|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110143|NCT01643928|OG000|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110144|NCT01643928|OG001|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110145|NCT01643928|OG002|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110146|NCT01643928|OG003|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11110147|NCT01643928|OG004|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110148|NCT01643928|EG000|Reported Event|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11126661|NCT01734772|EG003|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
11126662|NCT01734772|EG004|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
11110149|NCT01643928|EG001|Reported Event|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110150|NCT01643928|EG002|Reported Event|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110151|NCT01643928|EG003|Reported Event|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11110152|NCT01643928|EG004|Reported Event|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110153|NCT01643928|EG005|Reported Event|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110154|NCT01643928|EG006|Reported Event|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110155|NCT01643928|EG007|Reported Event|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110156|NCT01643928|EG008|Reported Event|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11110157|NCT01643928|EG009|Reported Event|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110158|NCT01643928|EG010|Reported Event|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11126663|NCT01734785|BG000|Baseline|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11126664|NCT01734785|BG001|Baseline|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
10879532|NCT00458393|FG000|Participant Flow|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
11110159|NCT01643928|EG011|Reported Event|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110160|NCT01643928|EG012|Reported Event|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110161|NCT01643928|EG013|Reported Event|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11110162|NCT01643928|EG014|Reported Event|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
11110163|NCT01644058|BG000|Baseline|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
11110164|NCT01644058|FG000|Participant Flow|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
11110165|NCT01644058|OG000|Outcome|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
11110166|NCT01644058|OG000|Outcome|Immediate Loading|"Immediate loading of 2 endo-osseous mandibular implants~Immediate loading"
11110167|NCT01644058|EG000|Reported Event|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
11110168|NCT01644149|BG000|Baseline|PharmaJet Stratis Injector|"Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector~Stratis Jet Injector: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine~2011-2012 Fluzone trivalent inactivated influenza vaccine"
11110169|NCT01644149|BG001|Baseline|Needle and Syringe|"Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe~Needle and Syringe: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine~2011-2012 Fluzone trivalent inactivated influenza vaccine"
11110170|NCT01644149|BG002|Baseline|Total|Total of all reporting groups
11110171|NCT01644149|FG000|Participant Flow|Stratis Jet Injector|"Patients assigned to this arm will receive Fluzone trivalent inactivated influenza vaccine administered using the STRATIS needle-free injection device. Fluzone vaccine (2011-2012 formulation): Patients will receive a single intramuscular injection of 0.5 ml of Fluzone vaccine in the deltoid region.~STRATIS needle-free injection device"
11110172|NCT01644149|FG001|Participant Flow|Needle-Syringe|"Patients assigned to this arm will receive Fluzone trivalent inactivated influenza vaccine administered using a needle and syringe. Fluzone vaccine (2011-2012 formulation): Patients will receive a single intramuscular injection of 0.5 ml of Fluzone vaccine in the deltoid region.~Needle-Syringe"
11110173|NCT01644149|OG000|Outcome|Stratis Jet Injector|"Patients assigned to this arm will receive Fluzone vaccine administered using the PharmaJet (PJ) STRATIS needle-free injection device.~Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
11110174|NCT01644149|OG001|Outcome|Needle and Syringe|"Patients assigned to this arm will receive Fluzone vaccine administered using needle and syringe.~Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.~Needle-Syringe."
11110175|NCT01644149|OG000|Outcome|Stratis Jet Injector|"Patients assigned to this arm will receive Fluzone vaccine administered using the PJ STRATIS needle-free injection device.~Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
11110176|NCT01644149|EG000|Reported Event|PharmaJet Stratis Injector|"Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector~Stratis Jet Injector: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine~2011-2012 Fluzone trivalent inactivated influenza vaccine"
11110177|NCT01644149|EG001|Reported Event|Needle and Syringe|"Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe~Needle and Syringe: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine~2011-2012 Fluzone trivalent inactivated influenza vaccine"
11110178|NCT01644175|BG000|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
10879533|NCT00458393|FG001|Participant Flow|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
11110179|NCT01644175|BG001|Baseline|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110180|NCT01644175|BG002|Baseline|Total|Total of all reporting groups
11110181|NCT01644175|FG000|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.
11110182|NCT01644175|FG001|Participant Flow|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110183|NCT01644175|OG000|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
11110184|NCT01644175|OG001|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110185|NCT01644175|EG000|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 45 weeks).
11110186|NCT01644175|EG001|Reported Event|Alirocumab 75 /up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 46 weeks).
11110187|NCT01644188|BG000|Baseline|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110188|NCT01644188|BG001|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
11110189|NCT01644188|BG002|Baseline|Total|Total of all reporting groups
11110190|NCT01644188|FG000|Participant Flow|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid- Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) level ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110191|NCT01644188|FG001|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
11110192|NCT01644188|OG000|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110193|NCT01644188|OG001|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
11110194|NCT01644188|EG000|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 /up to 150 mg Q2W added to stable LMT (mean exposition of 90 weeks).
11110195|NCT01644188|EG001|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg added to stable LMT (mean exposition of 90 weeks).
11110196|NCT01644240|BG000|Baseline|TD-8954 Dose 1|TD-8954: Intravenous infusion
11110197|NCT01644240|BG001|Baseline|Placebo|Placebo - saline: Intravenous infusion
10878615|NCT00453362|OG001|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
11110198|NCT01644240|BG002|Baseline|TD-8954 Dose 2|TD-8954: Intravenous infusion
11110199|NCT01644240|BG003|Baseline|Total|Total of all reporting groups
11110200|NCT01644240|FG000|Participant Flow|TD-8954 Dose 1|TD-8954: Intravenous infusion
11110201|NCT01644240|FG001|Participant Flow|Placebo|Placebo - saline: Intravenous infusion
11110202|NCT01644240|FG002|Participant Flow|TD-8954 Dose 2|TD-8954: Intravenous infusion
11110203|NCT01644240|OG000|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
11110204|NCT01644240|OG001|Outcome|Placebo|Placebo - saline: Intravenous infusion
10879534|NCT00458393|OG000|Outcome|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
10879535|NCT00458393|OG001|Outcome|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
11110205|NCT01644240|OG002|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
11110206|NCT01644240|EG000|Reported Event|TD-8954 Dose 1|TD-8954: Intravenous infusion
11110207|NCT01644240|EG001|Reported Event|Placebo|Placebo - saline: Intravenous infusion
11110208|NCT01644240|EG002|Reported Event|TD-8954 Dose 2|TD-8954: Intravenous infusion
11110209|NCT01644292|BG000|Baseline|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
11110210|NCT01644292|FG000|Participant Flow|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
11110211|NCT01644292|OG000|Outcome|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
11110212|NCT01644292|EG000|Reported Event|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
11110213|NCT01644331|BG000|Baseline|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
11110214|NCT01644331|BG001|Baseline|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
11110215|NCT01644331|BG002|Baseline|Total|Total of all reporting groups
11110216|NCT01644331|FG000|Participant Flow|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
11110217|NCT01644331|FG001|Participant Flow|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
11110218|NCT01644331|OG000|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
11110219|NCT01644331|OG001|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
11110220|NCT01644331|EG000|Reported Event|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
11110221|NCT01644331|EG001|Reported Event|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
11110222|NCT01644396|BG000|Baseline|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
11110223|NCT01644396|FG000|Participant Flow|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
11110224|NCT01644396|OG000|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
11110225|NCT01644396|OG000|Outcome|Adalimumab|Number of participants with adverse events
11110226|NCT01644396|EG000|Reported Event|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
10879536|NCT00458393|OG000|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
10879537|NCT00458393|OG001|Outcome|Placebo|Daily oral placebo
11110227|NCT01644474|BG000|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
11110228|NCT01644474|BG001|Baseline|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110229|NCT01644474|BG002|Baseline|Total|Total of all reporting groups
11110230|NCT01644474|FG000|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks.
11110231|NCT01644474|FG001|Participant Flow|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110232|NCT01644474|OG000|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
11110233|NCT01644474|OG001|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11110234|NCT01644474|EG000|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg (mean exposure of 22 weeks).
11110235|NCT01644474|EG001|Reported Event|Alirocumab 75/Up150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W (mean exposure of 22 weeks).
11110236|NCT01644500|BG000|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
11110237|NCT01644500|BG001|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
11110238|NCT01644500|BG002|Baseline|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
11110239|NCT01644500|BG003|Baseline|Total|Total of all reporting groups
11110240|NCT01644500|FG000|Participant Flow|1.5 mg Dulaglutide|1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
11110241|NCT01644500|FG001|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
11110242|NCT01644500|FG002|Participant Flow|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
11110243|NCT01644500|OG000|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
11110244|NCT01644500|OG001|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
11110245|NCT01644500|OG002|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
11110246|NCT01644500|EG000|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
11110247|NCT01644500|EG001|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
11110248|NCT01644500|EG002|Reported Event|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
11110249|NCT01644565|BG000|Baseline|All Study Cohorts|Baseline data within Final Clinical Study Report was not broken out by groups or cohorts. No randomization was presented to detail which subject was in which group or cohort. Data is presented as it was detailed in the FCSR.
11110250|NCT01644565|FG000|Participant Flow|Group A-1|"Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE"
11110251|NCT01644565|FG001|Participant Flow|Group A-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5"
11110252|NCT01644565|FG002|Participant Flow|Group A-3|"Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42~Modified E. coli heat labile enterotoxin LTR192G"
11110253|NCT01644565|FG003|Participant Flow|Group B-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110254|NCT01644565|FG004|Participant Flow|Group B-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5~Modified E. coli heat labile enterotoxin LTR192G"
11110255|NCT01644565|FG005|Participant Flow|Group C-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110256|NCT01644565|FG006|Participant Flow|Group C-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5~Modified E. coli heat labile enterotoxin LTR192G"
11110257|NCT01644565|FG007|Participant Flow|Group D-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110258|NCT01644565|FG008|Participant Flow|Group D-2|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110259|NCT01644565|OG000|Outcome|Group A-1|"Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE"
11110260|NCT01644565|OG001|Outcome|Group A-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5"
11110261|NCT01644565|OG002|Outcome|Group A-3|"Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42~Modified E. coli heat labile enterotoxin LTR192G"
11110262|NCT01644565|OG003|Outcome|Group B-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110263|NCT01644565|OG004|Outcome|Group B-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5~Modified E. coli heat labile enterotoxin LTR192G"
11110264|NCT01644565|OG005|Outcome|Group C-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110265|NCT01644565|OG006|Outcome|Group C-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5~Modified E. coli heat labile enterotoxin LTR192G"
11110266|NCT01644565|OG007|Outcome|Group D-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110267|NCT01644565|OG008|Outcome|Group D-2|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110268|NCT01644565|EG000|Reported Event|Group A-1|"Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE"
11110269|NCT01644565|EG001|Reported Event|Group A-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5"
11110270|NCT01644565|EG002|Reported Event|Group A-3|"Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42~Modified E. coli heat labile enterotoxin LTR192G"
11110271|NCT01644565|EG003|Reported Event|Group B-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
10848760|NCT00291343|EG000|Reported Event|Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group|Subjects previously primed with 3 doses of Tritanrix-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
11110272|NCT01644565|EG004|Reported Event|Group B-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5~Modified E. coli heat labile enterotoxin LTR192G"
11110273|NCT01644565|EG005|Reported Event|Group C-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110274|NCT01644565|EG006|Reported Event|Group C-2|"Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5~Modified E. coli heat labile enterotoxin LTR192G"
11110275|NCT01644565|EG007|Reported Event|Group D-1|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110276|NCT01644565|EG008|Reported Event|Group D-2|"Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42~Recombinant fimbrial adhesin dscCfaE~Modified E. coli heat labile enterotoxin LTR192G"
11110277|NCT01644617|BG000|Baseline|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
11110278|NCT01644617|BG001|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
11110279|NCT01644617|BG002|Baseline|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
11110280|NCT01644617|BG003|Baseline|Total|Total of all reporting groups
11110281|NCT01644617|FG000|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
11110282|NCT01644617|FG001|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
11110283|NCT01644617|FG002|Participant Flow|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
11110284|NCT01644617|OG000|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
11110285|NCT01644617|OG001|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
11110286|NCT01644617|OG002|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
11110287|NCT01644617|EG000|Reported Event|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
11110288|NCT01644617|EG001|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
11110289|NCT01644617|EG002|Reported Event|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
11110290|NCT01644643|BG000|Baseline|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
11110291|NCT01644643|BG001|Baseline|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
11110292|NCT01644643|BG002|Baseline|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
11110293|NCT01644643|BG003|Baseline|cUTI:CAZ-AVI|cUTI: CAZ-AVI
11110294|NCT01644643|BG004|Baseline|Total|Total of all reporting groups
11110295|NCT01644643|FG000|Participant Flow|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
11110296|NCT01644643|FG001|Participant Flow|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
11110297|NCT01644643|FG002|Participant Flow|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
11110298|NCT01644643|FG003|Participant Flow|cUTI:CAZ-AVI|cUTI: CAZ-AVI
11110299|NCT01644643|OG000|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
11110300|NCT01644643|OG001|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
11110301|NCT01644643|OG002|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
11110302|NCT01644643|OG003|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
11110303|NCT01644643|OG000|Outcome|CAZ (1)|15 mins before/after dose
11110304|NCT01644643|OG001|Outcome|AVI (1)|15 mins before/after dose
11110305|NCT01644643|OG002|Outcome|CAZ (2)|30-90 mins after dose
11110306|NCT01644643|OG003|Outcome|AVI (2)|30-90 mins after dose
11110307|NCT01644643|OG004|Outcome|CAZ (3)|300-360 mins after dose
11110308|NCT01644643|OG005|Outcome|AVI (3)|300-360 mins after dose
11110309|NCT01644643|EG000|Reported Event|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
11110310|NCT01644643|EG001|Reported Event|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
11110311|NCT01644643|EG002|Reported Event|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
11110312|NCT01644643|EG003|Reported Event|cUTI:CAZ-AVI|cUTI: CAZ-AVI
11126665|NCT01734785|BG002|Baseline|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11126666|NCT01734785|BG003|Baseline|Total|Total of all reporting groups
11110313|NCT01644695|BG000|Baseline|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
11110314|NCT01644695|FG000|Participant Flow|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
11110315|NCT01644695|OG000|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
11110316|NCT01644695|EG000|Reported Event|All Participants|No participant was excempt from this measure.
11110317|NCT01644734|BG000|Baseline|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
11110318|NCT01644734|FG000|Participant Flow|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
11110319|NCT01644734|OG000|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
11110320|NCT01644734|EG000|Reported Event|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
11110321|NCT01644890|BG000|Baseline|NK105|received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
11110322|NCT01644890|BG001|Baseline|Paclitaxel|received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
11110323|NCT01644890|BG002|Baseline|Total|Total of all reporting groups
11110324|NCT01644890|FG000|Participant Flow|NK105|received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
11110325|NCT01644890|FG001|Participant Flow|Paclitaxel|received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
11110326|NCT01644890|OG000|Outcome|NK105|received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
11110327|NCT01644890|OG001|Outcome|Paclitaxel|received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
11110328|NCT01644890|EG000|Reported Event|NK105|received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
11110329|NCT01644890|EG001|Reported Event|Paclitaxel|received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
11110330|NCT01645059|BG000|Baseline|Disseminated Her 2+ Breast Cancer|
11110331|NCT01645059|FG000|Participant Flow|Disseminated Her 2+ Breast Cancer|
11110332|NCT01645059|OG000|Outcome|Disseminated Her 2+ Breast Cancer|
11110333|NCT01645059|OG000|Outcome|Disseminated HER 2 + Breast Cancer|
11110334|NCT01645059|OG000|Outcome|Trastuzumab Adjuvant Treatment|
11110335|NCT01645059|OG001|Outcome|No Trastuzumab Adjuvant Treatment|
11110336|NCT01645059|OG000|Outcome|Taxanes First Line Treatment|
11110337|NCT01645059|OG001|Outcome|No Taxanes First Line Treatment|
11110338|NCT01645059|EG000|Reported Event|Disseminated Her 2+ Breast Cancer|
11110339|NCT01645098|BG000|Baseline|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
11110340|NCT01645098|BG001|Baseline|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
11110341|NCT01645098|BG002|Baseline|Total|Total of all reporting groups
11110342|NCT01645098|FG000|Participant Flow|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
11110343|NCT01645098|FG001|Participant Flow|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
11110344|NCT01645098|OG000|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
11110345|NCT01645098|OG001|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
11110346|NCT01645098|EG000|Reported Event|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
11110347|NCT01645098|EG001|Reported Event|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
11110348|NCT01645111|BG000|Baseline|Clevidipine|Clevidipine
11110349|NCT01645111|FG000|Participant Flow|Clevidipine|Clevidipine
11110350|NCT01645111|OG000|Outcome|Clevidipine|Clevidipine
11110351|NCT01645111|EG000|Reported Event|Clevidipine|Clevidipine
11110352|NCT01645176|BG000|Baseline|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
11110353|NCT01645176|FG000|Participant Flow|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
11110354|NCT01645176|OG000|Outcome|Osteoarthritis of Knee|Change in MRI synovitis
11110355|NCT01645176|EG000|Reported Event|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
11110356|NCT01645280|BG000|Baseline|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
11110357|NCT01645280|BG001|Baseline|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110358|NCT01645280|BG002|Baseline|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
11110359|NCT01645280|BG003|Baseline|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110360|NCT01645280|BG004|Baseline|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110361|NCT01645280|BG005|Baseline|Total|Total of all reporting groups
11110362|NCT01645280|FG000|Participant Flow|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
11110363|NCT01645280|FG001|Participant Flow|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110364|NCT01645280|FG002|Participant Flow|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
10879538|NCT00458393|EG000|Reported Event|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
11110365|NCT01645280|FG003|Participant Flow|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110366|NCT01645280|FG004|Participant Flow|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110367|NCT01645280|OG000|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
11110368|NCT01645280|OG001|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110369|NCT01645280|OG002|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
11110370|NCT01645280|OG003|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110371|NCT01645280|OG004|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110372|NCT01645280|EG000|Reported Event|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
11110373|NCT01645280|EG001|Reported Event|Placebo (Early Escape)|Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate.
11110374|NCT01645280|EG002|Reported Event|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110375|NCT01645280|EG003|Reported Event|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
11110376|NCT01645280|EG004|Reported Event|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110377|NCT01645280|EG005|Reported Event|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
11110378|NCT01645306|BG000|Baseline|Placebo|"Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Placebo: single intravenous injection"
11110379|NCT01645306|BG001|Baseline|40 mg Revacept|"40 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Revacept: single intravenous injection"
11110380|NCT01645306|BG002|Baseline|120 mg Revacept|"120 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Revacept: single intravenous injection"
11110381|NCT01645306|BG003|Baseline|Total|Total of all reporting groups
11110382|NCT01645306|FG000|Participant Flow|Placebo|"Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Placebo: single intravenous injection"
11110383|NCT01645306|FG001|Participant Flow|40 mg Revacept|"40 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Revacept: single intravenous injection"
11110384|NCT01645306|FG002|Participant Flow|120 mg Revacept|"120 mg in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Revacept: single intravenous injection"
11110385|NCT01645306|OG000|Outcome|Placebo|"Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Placebo: single intravenous injection"
11110386|NCT01645306|OG001|Outcome|40 mg Revacept|"in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Revacept: single intravenous injection"
11110387|NCT01645306|OG002|Outcome|120 mg Revacept|"in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Revacept: single intravenous injection"
11110388|NCT01645306|EG000|Reported Event|Placebo|"Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Placebo: single intravenous injection"
11110389|NCT01645306|EG001|Reported Event|40 mg Revacept|"in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Revacept: single intravenous injection"
11110390|NCT01645306|EG002|Reported Event|120 mg Revacept|"in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol~Revacept: single intravenous injection"
11110391|NCT01645735|BG000|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
11110392|NCT01645735|BG001|Baseline|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
11110393|NCT01645735|BG002|Baseline|Total|Total of all reporting groups
11110394|NCT01645735|FG000|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
11110395|NCT01645735|FG001|Participant Flow|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
11110396|NCT01645735|OG000|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
11110397|NCT01645735|OG001|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
11110398|NCT01645735|OG001|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV q24 plus vancomycin 15mg/kg IV q12h initially and then dose adjusted based on trough concentrations
11110399|NCT01645735|EG000|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
11110400|NCT01645735|EG001|Reported Event|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
11110401|NCT01645930|BG000|Baseline|Ixazomib+Lenalidomide+Dexamethasone|Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
11110402|NCT01645930|FG000|Participant Flow|Ixazomib+Lenalidomide+Dexamethasone|Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
11110403|NCT01645930|OG000|Outcome|Ixazomib+Lenalidomide+Dexamethasone|Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
10879539|NCT00458393|EG001|Reported Event|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
11110404|NCT01645930|EG000|Reported Event|Ixazomib+Lenalidomide+Dexamethasone|Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
11110405|NCT01646021|BG000|Baseline|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
11110406|NCT01646021|BG001|Baseline|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
11110407|NCT01646021|BG002|Baseline|Total|Total of all reporting groups
11110408|NCT01646021|FG000|Participant Flow|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
11110409|NCT01646021|FG001|Participant Flow|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
11110410|NCT01646021|OG000|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
11110411|NCT01646021|OG001|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
11110412|NCT01646021|EG000|Reported Event|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
11110413|NCT01646021|EG001|Reported Event|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
10879540|NCT00458406|BG000|Baseline|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
11110414|NCT01646073|BG000|Baseline|Placebo|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B
11110415|NCT01646073|BG001|Baseline|Adalimumab Eow|Participants were started on adalimumab 40 mg every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
11110416|NCT01646073|BG002|Baseline|Total|Total of all reporting groups
11110417|NCT01646073|FG000|Participant Flow|Placebo|Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B
11110418|NCT01646073|FG001|Participant Flow|Adalimumab Eow|Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
11110419|NCT01646073|OG000|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
11110420|NCT01646073|OG001|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
11110421|NCT01646073|OG000|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
11110422|NCT01646073|OG001|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
11110423|NCT01646073|EG000|Reported Event|Double-blind Placebo|Participants were started on placebo in Period A (Week 0 to Week 12)
11110424|NCT01646073|EG001|Reported Event|Double-blind Adalimumab Eow|Participants were started on adalimumab eow in Period A (Week 0 to Week 12)
11110425|NCT01646073|EG002|Reported Event|Any Adalimumab|Participants that received at least one dose of adalimumab during Period A or Period B
11110426|NCT01646125|BG000|Baseline|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
11110427|NCT01646125|BG001|Baseline|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
11110428|NCT01646125|BG002|Baseline|Total|Total of all reporting groups
11110429|NCT01646125|FG000|Participant Flow|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
11110430|NCT01646125|FG001|Participant Flow|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
11110431|NCT01646125|OG000|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
11110432|NCT01646125|OG001|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
11110433|NCT01646125|EG000|Reported Event|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
11110434|NCT01646125|EG001|Reported Event|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
11110435|NCT01646125|EG002|Reported Event|Total|Total
11110436|NCT01646138|BG000|Baseline|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
11110437|NCT01646138|BG001|Baseline|10^4 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^4 TCID50 administered intranasally.
11110438|NCT01646138|BG002|Baseline|10^5 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^5 TCID50 administered intranasally.
11110439|NCT01646138|BG003|Baseline|10^6 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^6 TCID50 administered intranasally.
11110440|NCT01646138|BG004|Baseline|10^7 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^7 TCID50 administered intranasally.
11110441|NCT01646138|BG005|Baseline|Total|Total of all reporting groups
11110442|NCT01646138|FG000|Participant Flow|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
11110443|NCT01646138|FG001|Participant Flow|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
11110444|NCT01646138|FG002|Participant Flow|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
11110445|NCT01646138|FG003|Participant Flow|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
11110446|NCT01646138|FG004|Participant Flow|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
11110447|NCT01646138|OG000|Outcome|10^3 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^3 TCID 50 administered intranasally.
11110448|NCT01646138|OG001|Outcome|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
11110449|NCT01646138|OG002|Outcome|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
11110450|NCT01646138|OG003|Outcome|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
11110451|NCT01646138|OG004|Outcome|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
11110452|NCT01646138|EG000|Reported Event|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
11110453|NCT01646138|EG001|Reported Event|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
11110454|NCT01646138|EG002|Reported Event|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
11110455|NCT01646138|EG003|Reported Event|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
11110456|NCT01646138|EG004|Reported Event|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
11110457|NCT01646151|BG000|Baseline|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
11110458|NCT01646151|FG000|Participant Flow|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
11110459|NCT01646151|OG000|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
11110460|NCT01646151|EG000|Reported Event|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
11110461|NCT01646177|BG000|Baseline|Placebo|Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
11110462|NCT01646177|BG001|Baseline|50 mg Etanercept|Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
11110463|NCT01646177|BG002|Baseline|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
11110464|NCT01646177|BG003|Baseline|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
11110465|NCT01646177|BG004|Baseline|Total|Total of all reporting groups
11110466|NCT01646177|FG000|Participant Flow|Placebo|Placebo (PBO) for ixekizumab (Week 0) given as 2 subcutaneous (SC) injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
11110467|NCT01646177|FG001|Participant Flow|50 mg Etanercept (ETN)|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
11110468|NCT01646177|FG002|Participant Flow|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
11110469|NCT01646177|FG003|Participant Flow|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
11110470|NCT01646177|FG004|Participant Flow|PBO/IXE80Q4W|Participants who received placebo during the induction period and received 80 mg ixekizumab SC injection every four weeks (IXE80Q4W) in the Long-term extension period.
11110471|NCT01646177|FG005|Participant Flow|ETN/IXE80Q4W|Participants who received Etanercept during the induction period and received IXE80Q4W in the long-term extension period.
11110472|NCT01646177|FG006|Participant Flow|IXE80Q4W/IXE80Q4W|Participants who received 80 mg ixe Q4W during the induction period and received IXE80Q4W in the long-term extension period.
11110473|NCT01646177|FG007|Participant Flow|IXE80Q2W/IXE80Q4W|Participants who received 80 mg ixe Q2W (IXE80Q2W) during the induction period and received IXE80Q4W in the long-term extension period.
11110474|NCT01646177|FG008|Participant Flow|PBO Follow-Up Period|Participants who received PBO in the Induction Period and entered the Post-Treatment Follow-up Period.
11110475|NCT01646177|FG009|Participant Flow|ETN Follow-Up Period|Participants who received etanercept (ETN) in the Induction Period and entered the Post-Treatment Follow-up Period.
11110476|NCT01646177|FG010|Participant Flow|IXE80Q4W Follow-Up Period|Participants who received 80 mg ixe Q4W in the Induction Period and entered the Post-Treatment Follow-up Period.
10879541|NCT00458406|BG001|Baseline|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
10879542|NCT00458406|BG002|Baseline|Total|Total of all reporting groups
11110477|NCT01646177|FG011|Participant Flow|IXE80Q2W Follow-Up Period|Participants who received 80 mg ixe Q2W in the Induction Period and entered the Post-Treatment Follow-up Period.
11110478|NCT01646177|OG000|Outcome|Placebo|Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
11110479|NCT01646177|OG001|Outcome|50 mg Etanercept|Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
11110480|NCT01646177|OG002|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
11110481|NCT01646177|OG003|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
11110482|NCT01646177|OG001|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
11110483|NCT01646177|OG003|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
11110484|NCT01646177|EG000|Reported Event|Placebo|Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 (Q2W) until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).
11110485|NCT01646177|EG001|Reported Event|50 mg Etanercept|Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
11110486|NCT01646177|EG002|Reported Event|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
11110487|NCT01646177|EG003|Reported Event|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
11110488|NCT01646177|EG004|Reported Event|PBO/IXE80Q4W Long-Term Extension|Participants who received placebo during the induction period and received 80 mg ixekizumab SC injection every four weeks (IXE80Q4W) in the Long-term extension period.
11110489|NCT01646177|EG005|Reported Event|ETN/IXE80Q4W Long-Term Extension|Participants who received Etanercept during the induction period and received IXE80Q4W in the long-term extension period.
11110490|NCT01646177|EG006|Reported Event|IXE80Q4W/IXE80Q4W Long-Term Extension|Participants who received 80 mg ixe Q4W during the induction period and received IXE80Q4W in the long-term extension period.
11110491|NCT01646177|EG007|Reported Event|IXE80Q2W/IXE80Q4W Long-Term Extension|Participants who received 80 mg ixe Q2W (IXE80Q2W) during the induction period and received IXE80Q4W in the long-term extension period.
11110492|NCT01646177|EG008|Reported Event|PBO Follow-Up Period|Participants who received PBO in the Induction Period and entered the Post-Treatment Follow-up Period.
11110493|NCT01646177|EG009|Reported Event|ETN Follow-Up Period|Participants who received ETN in the Induction Period and entered the Post-Treatment Follow-up Period.
11110494|NCT01646177|EG010|Reported Event|IXE80Q4W Follow-Up|Participants who received 80 mg ixe Q4W in the Induction Period and entered the Post-Treatment Follow-up Period.
11110495|NCT01646177|EG011|Reported Event|IXE80Q2W Follow-Up|Participants who received 80 mg ixe Q2W in the Induction Period and entered the Post-Treatment Follow-up Period.
11110496|NCT01646203|BG000|Baseline|1.25 mg/kg LY3022859|Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
11110497|NCT01646203|BG001|Baseline|12.5 mg LY3022859|Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
11110498|NCT01646203|BG002|Baseline|25 mg LY3022859|Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
11110499|NCT01646203|BG003|Baseline|Total|Total of all reporting groups
11110500|NCT01646203|FG000|Participant Flow|1.25 mg/kg LY3022859|Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
11110501|NCT01646203|FG001|Participant Flow|12.5 mg LY3022859|Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
11110502|NCT01646203|FG002|Participant Flow|25 mg LY3022859|Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
11110503|NCT01646203|OG000|Outcome|1.25 mg/kg LY3022859|Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
11110504|NCT01646203|OG001|Outcome|12.5 mg LY3022859|Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
11110505|NCT01646203|OG002|Outcome|25 mg LY3022859|Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
11110506|NCT01646203|OG000|Outcome|All Participants Receiving a Flat Dose|"12.5 mg LY3022859 Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.~25 mg LY3022859 Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles."
11110507|NCT01646203|OG000|Outcome|All Participants Receiving a Weight-Based Dose|1.25 mg/kg LY3022859 Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
11110508|NCT01646203|OG002|Outcome|25 mg LY3022859|Cohort 2: 25mg IV once Q2W during 6-week treatment cycles.
11110509|NCT01646203|OG000|Outcome|12.5 mg LY3022859|Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
11110510|NCT01646203|OG001|Outcome|25 mg LY3022859|Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.
11110511|NCT01646203|EG000|Reported Event|1.25 mg/kg LY3022859|Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.
11110512|NCT01646203|EG001|Reported Event|12.5 mg LY3022859|Cohorts 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.
11110513|NCT01646203|EG002|Reported Event|25 mg LY3022859|Cohorts 2: 25 mg IV once Q2W during 6-week treatment cycles.
11110514|NCT01646216|BG000|Baseline|Split-belt Treadmill Exercise|"Split-belt treadmill training~Split belt treadmill: A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds."
11110515|NCT01646216|BG001|Baseline|Tied-belt Treadmill Exercise|"Tied-belt treadmill training~The treadmill is run like a typical treadmill that is seen in the gym except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds are set to move at the same speed, making this treadmill training group similar to any regular treadmill."
11110516|NCT01646216|BG002|Baseline|Total|Total of all reporting groups
11126667|NCT01734785|FG000|Participant Flow|Empagliflozin 25 mg|Patients received 1 fixed dose combination (FDC) Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11110517|NCT01646216|FG000|Participant Flow|Split-belt Treadmill Exercise|"Split-belt treadmill training~Split belt treadmill: A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds."
11110518|NCT01646216|FG001|Participant Flow|Tied-belt Treadmill Exercise|"Tied-belt treadmill training~The treadmill is run like a typical treadmill that is seen in the gym except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds are set to move at the same speed, making this treadmill training group similar to any regular treadmill."
11110519|NCT01646216|OG000|Outcome|Split-belt, Mild Disability|Subjects trained on split belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There were two subjects in this group.
11110520|NCT01646216|OG001|Outcome|Split-belt, Moderate Disability|Subjects trained on split belt treadmill. Subjects in the moderate disability group had baseline walking speeds of 0.4 m/s to 0.8 m/s. There were two subjects in this group.
11110521|NCT01646216|OG002|Outcome|Split-belt Severe Disability|Subjects trained on split belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were two subjects in this group.
11110522|NCT01646216|OG003|Outcome|Tied-belt, Severe Disability|Subjects trained on tied belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were three subjects in this group.
11110523|NCT01646216|OG004|Outcome|Tied-belt Mild Disability|Subjects trained on tied belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There was one subject in this group.
11110524|NCT01646216|OG004|Outcome|Tied-belt Mild Disability|Subjects trained on tied belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There was one subject in this group
11110525|NCT01646216|EG000|Reported Event|Split-belt Treadmill Exercise|"Split-belt treadmill training~Split belt treadmill: A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds."
11110526|NCT01646216|EG001|Reported Event|Tied-belt Treadmill Exercise|Tied-belt treadmill training The treadmill is run like a typical treadmill that is seen in the gym except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds are set to move at the same speed, making this treadmill training group similar to any regular treadmill.
11110527|NCT01646255|BG000|Baseline|Placebo|Subjects randomized to placebo received matching placebo patches.
11110528|NCT01646255|BG001|Baseline|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
11110529|NCT01646255|BG002|Baseline|Total Title|
11110530|NCT01646255|FG000|Participant Flow|Placebo|Subjects randomized to placebo received matching placebo patches.
11110531|NCT01646255|FG001|Participant Flow|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
11110532|NCT01646255|OG000|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
11110533|NCT01646255|OG001|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
11110534|NCT01646255|OG001|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
11110535|NCT01646255|EG000|Reported Event|Placebo|"Placebo, daily doses, placebo Group~Subjects randomized to placebo will receive matching placebo patches."
11110536|NCT01646255|EG001|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group~Subjects will receive rotigotine or placebo patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo is achieved. A combination of patches (rotigotine or matching placebo) will be applied for subjects who require a dose > 8 mg/ 24 h. Each dose level is maintained for 1 week."
11110537|NCT01646268|BG000|Baseline|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
11110538|NCT01646268|BG001|Baseline|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
11110539|NCT01646268|BG002|Baseline|Total|Total of all reporting groups
11110540|NCT01646268|FG000|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
11110541|NCT01646268|FG001|Participant Flow|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
11110542|NCT01646268|OG000|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
11110543|NCT01646268|OG001|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
11110544|NCT01646268|EG000|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
11110545|NCT01646268|EG001|Reported Event|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
11110546|NCT01646320|BG000|Baseline|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
11110547|NCT01646320|BG001|Baseline|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
11110548|NCT01646320|BG002|Baseline|Total|Total of all reporting groups
11110549|NCT01646320|FG000|Participant Flow|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
11110550|NCT01646320|FG001|Participant Flow|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
11110551|NCT01646320|OG000|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
11110552|NCT01646320|OG001|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
11110553|NCT01646320|EG000|Reported Event|DAPA + SAXA + MET|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
11110554|NCT01646320|EG001|Reported Event|PLA + SAXA + MET|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
11110555|NCT01646346|BG000|Baseline|4D Conformal Image-Guided Partial Breast RT|"This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.~4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days."
11110556|NCT01646346|FG000|Participant Flow|4D Conformal Image-Guided Partial Breast RT|"This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.~4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days."
11110557|NCT01646346|OG000|Outcome|4D Conformal Image-Guided Partial Breast RT|"This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.~4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days."
11110558|NCT01646346|EG000|Reported Event|4D Conformal Image-Guided Partial Breast RT|"This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.~4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days."
11110559|NCT01646385|BG000|Baseline|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up.
11110560|NCT01646385|BG001|Baseline|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
11110561|NCT01646385|BG002|Baseline|Total|Total of all reporting groups
11110562|NCT01646385|FG000|Participant Flow|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up.
11110563|NCT01646385|FG001|Participant Flow|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
11126668|NCT01734785|FG001|Participant Flow|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11110564|NCT01646385|OG000|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up.
11110565|NCT01646385|OG001|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
11110566|NCT01646385|EG000|Reported Event|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up.
11110567|NCT01646385|EG001|Reported Event|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
11110568|NCT01646398|BG000|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
11110569|NCT01646398|BG001|Baseline|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
11110570|NCT01646398|BG002|Baseline|Total|Total of all reporting groups
11110571|NCT01646398|FG000|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
11110572|NCT01646398|FG001|Participant Flow|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
11110573|NCT01646398|OG000|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
11110574|NCT01646398|OG001|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
10878616|NCT00453362|OG001|Outcome|Erlotinib_ FDG Non-Responder|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
11110575|NCT01646398|EG000|Reported Event|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
11110576|NCT01646398|EG001|Reported Event|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
11110577|NCT01646645|BG000|Baseline|Group I|"This is a single-arm non-randomized single institution phase 2 trial, designed to evaluate the therapeutic activity of CMVpp65-CTLs generated from seropositive HSCT donors when adoptively transferred into transplant recipients with persistent CMV infection or viremia. Patients eligible for this trial will be consenting recipients of related or unrelated HSCT who have an active CMV infection or persistent CMV viremia for ≥ 2 weeks despite treatment with anti-viral agents or who cannot be maintained on anti-viral therapy due to treatment related toxicity.~CMV-pp65 CTLs: Patients will be treated with CMVpp65-CTLs derived from their transplant donor. These will be patients with CMV seropositive transplant donors who have previously provided leukocytes for generation of CMVpp65-CTL and for whom such CMVpp65-CTL are available. The T-cells to be infused will be selected based on criteria mentioned in section 4.0 from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 106 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement."
11110578|NCT01646645|FG000|Participant Flow|Group I|"This is a single-arm non-randomized single institution phase 2 trial, designed to evaluate the therapeutic activity of CMVpp65-CTLs generated from seropositive HSCT donors when adoptively transferred into transplant recipients with persistent CMV infection or viremia. Patients eligible for this trial will be consenting recipients of related or unrelated HSCT who have an active CMV infection or persistent CMV viremia for ≥ 2 weeks despite treatment with anti-viral agents or who cannot be maintained on anti-viral therapy due to treatment related toxicity.~CMV-pp65 CTLs: Patients will be treated with CMVpp65-CTLs derived from their transplant donor. These will be patients with CMV seropositive transplant donors who have previously provided leukocytes for generation of CMVpp65-CTL and for whom such CMVpp65-CTL are available. The T-cells to be infused will be selected based on criteria mentioned in section 4.0 from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 106 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement."
11126669|NCT01734785|FG002|Participant Flow|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11126670|NCT01734785|FG003|Participant Flow|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
11110579|NCT01646645|OG000|Outcome|Group I|"This is a single-arm non-randomized single institution phase 2 trial, designed to evaluate the therapeutic activity of CMVpp65-CTLs generated from seropositive HSCT donors when adoptively transferred into transplant recipients with persistent CMV infection or viremia. Patients eligible for this trial will be consenting recipients of related or unrelated HSCT who have an active CMV infection or persistent CMV viremia for ≥ 2 weeks despite treatment with anti-viral agents or who cannot be maintained on anti-viral therapy due to treatment related toxicity.~CMV-pp65 CTLs: Patients will be treated with CMVpp65-CTLs derived from their transplant donor. These will be patients with CMV seropositive transplant donors who have previously provided leukocytes for generation of CMVpp65-CTL and for whom such CMVpp65-CTL are available. The T-cells to be infused will be selected based on criteria mentioned in section 4.0 from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 106 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement."
11110580|NCT01646645|EG000|Reported Event|Group I|"This is a single-arm non-randomized single institution phase 2 trial, designed to evaluate the therapeutic activity of CMVpp65-CTLs generated from seropositive HSCT donors when adoptively transferred into transplant recipients with persistent CMV infection or viremia. Patients eligible for this trial will be consenting recipients of related or unrelated HSCT who have an active CMV infection or persistent CMV viremia for ≥ 2 weeks despite treatment with anti-viral agents or who cannot be maintained on anti-viral therapy due to treatment related toxicity.~CMV-pp65 CTLs: Patients will be treated with CMVpp65-CTLs derived from their transplant donor. These will be patients with CMV seropositive transplant donors who have previously provided leukocytes for generation of CMVpp65-CTL and for whom such CMVpp65-CTL are available. The T-cells to be infused will be selected based on criteria mentioned in section 4.0 from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 106 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement."
11110581|NCT01646671|BG000|Baseline|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
11110582|NCT01646671|BG001|Baseline|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
11110583|NCT01646671|BG002|Baseline|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
11110584|NCT01646671|BG003|Baseline|Total|Total of all reporting groups
11110585|NCT01646671|FG000|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
11110586|NCT01646671|FG001|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
11110587|NCT01646671|FG002|Participant Flow|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
11110588|NCT01646671|OG000|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
11110589|NCT01646671|OG001|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
11110590|NCT01646671|OG002|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
11110591|NCT01646671|OG003|Outcome|Total Participants|All participants who were treated
11110592|NCT01646671|EG000|Reported Event|LCZ 200 mg|LCZ 200 mg
11110593|NCT01646671|EG001|Reported Event|LCZ 400 mg|LCZ 400 mg
11110594|NCT01646671|EG002|Reported Event|LCZ 400 mg + Other HTN Medications|LCZ 400 mg + other HTN medications
11110595|NCT01646671|EG003|Reported Event|Total Participants|All participants who were treated
11110596|NCT01646762|BG000|Baseline|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
11110597|NCT01646762|FG000|Participant Flow|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
11110598|NCT01646762|OG000|Outcome|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
11110599|NCT01646762|EG000|Reported Event|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
11110600|NCT01646827|BG000|Baseline|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
11110601|NCT01646827|BG001|Baseline|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
11110602|NCT01646827|BG002|Baseline|Total|Total of all reporting groups
11110603|NCT01646827|FG000|Participant Flow|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
11110604|NCT01646827|FG001|Participant Flow|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
11110605|NCT01646827|OG000|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
11110606|NCT01646827|OG001|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
11110607|NCT01646827|EG000|Reported Event|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single aripiprazole IM depot (400 mg) injection in the deltoid muscle.
11110608|NCT01646827|EG001|Reported Event|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single aripiprazole IM depot (400 mg) injection in the gluteal muscle.
11110609|NCT01647217|BG000|Baseline|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
11110610|NCT01647217|BG001|Baseline|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
11110611|NCT01647217|BG002|Baseline|Total|Total of all reporting groups
11110612|NCT01647217|FG000|Participant Flow|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
11110613|NCT01647217|FG001|Participant Flow|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
11110614|NCT01647217|OG000|Outcome|Terpinen-4-ol Treatment Arm|"10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
11110615|NCT01647217|OG001|Outcome|Placepo Pads Contol Arm|"10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
11110616|NCT01647217|OG000|Outcome|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
11110617|NCT01647217|OG001|Outcome|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
11110618|NCT01647217|EG000|Reported Event|Terpinen-4-ol Treatment Arm|"10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
11110619|NCT01647217|EG001|Reported Event|Placepo Pads Contol Arm|"10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
11110620|NCT01647282|BG000|Baseline|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
11110621|NCT01647282|BG001|Baseline|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
11110622|NCT01647282|BG002|Baseline|Total|Total of all reporting groups
11110623|NCT01647282|FG000|Participant Flow|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
11110624|NCT01647282|FG001|Participant Flow|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
11110625|NCT01647282|OG000|Outcome|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
11110626|NCT01647282|OG001|Outcome|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
11110627|NCT01647282|EG000|Reported Event|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
11110628|NCT01647282|EG001|Reported Event|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
11110629|NCT01647438|BG000|Baseline|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
11110630|NCT01647438|BG001|Baseline|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
11110631|NCT01647438|BG002|Baseline|Total|Total of all reporting groups
11110632|NCT01647438|FG000|Participant Flow|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
11110633|NCT01647438|FG001|Participant Flow|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
11110634|NCT01647438|OG000|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
11110635|NCT01647438|OG001|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
11110636|NCT01647438|EG000|Reported Event|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
11110637|NCT01647438|EG001|Reported Event|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
11110638|NCT01647464|BG000|Baseline|Contrast Administration|Patients undergoing contrast-enhanced echo.
11110639|NCT01647464|FG000|Participant Flow|Contrast Administration|Patients undergoing contrast-enhanced echo.
11110640|NCT01647464|OG000|Outcome|Contrast Administration|Patients undergoing contrast-enhanced echo.
11110641|NCT01647464|EG000|Reported Event|Contrast Administration|Patients undergoing contrast-enhanced echo.
11110642|NCT01647516|BG000|Baseline|Placebo|Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
11110643|NCT01647516|BG001|Baseline|Ozanimod Hydrochloride 0.5 mg|Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.
11110644|NCT01647516|BG002|Baseline|Ozanimod Hydrochloride 1 mg|Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.
11110645|NCT01647516|BG003|Baseline|Total|Total of all reporting groups
11110646|NCT01647516|FG000|Participant Flow|Placebo|Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
11110647|NCT01647516|FG001|Participant Flow|Ozanimod Hydrochloride 0.5 mg|Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.
11110648|NCT01647516|FG002|Participant Flow|Ozanimod Hydrochloride 1 mg|Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.
11110649|NCT01647516|FG003|Participant Flow|Open-Label Treatment Period (OLP): Placebo/Ozanimod|Participants who received placebo capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and receive 1 mg ozanimod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
11110650|NCT01647516|FG004|Participant Flow|OLP: Ozanimod 0.5 mg/Ozanimod 1 mg|Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
11110651|NCT01647516|FG005|Participant Flow|OLP: Ozanimod 1 mg/Ozanimod 1 mg|Participants who received 1 mg ozanimod capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and continue to receive 1 mg ozaninod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
11110652|NCT01647516|OG000|Outcome|Placebo|Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).
11110653|NCT01647516|OG001|Outcome|Ozanimod Hydrochloride 0.5 mg|Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.
11110654|NCT01647516|OG002|Outcome|Ozanimod Hydrochloride 1 mg|Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.
11110655|NCT01647516|OG000|Outcome|Ozanimod|Participants who completed the induction period and were non-responders at Week 8 and those who completed the maintenance period or experienced a disease relapse entered the open label treatment period (OLP) and received 1 mg ozaninod daily up to 6 years. Participants who did not show clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
11110656|NCT01647516|EG000|Reported Event|Induction Period: Placebo|Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9).
11110657|NCT01647516|EG001|Reported Event|Induction Period: Ozanimod HCL 0.5 mg|Participants received 0.5 mg ozanimod capsules daily during the induction period (weeks 0 to 9).
11110658|NCT01647516|EG002|Reported Event|Induction Period: Ozanimod HCL 1 mg|Participants received 1 mg ozanimod capsules daily during the induction period (weeks 0 to 9).
11110659|NCT01647516|EG003|Reported Event|Maintenance Period: Placebo|Participants originally assigned to placebo who completed the induction period and were responders at week 8 continued to receive placebo in the maintenance period. Participants received identically matching placebo capsules daily during the maintenance period (weeks 9-32).
11110660|NCT01647516|EG004|Reported Event|Maintenance Period: Ozanimod HCL 0.5 mg|Participants originally assigned to ozanimod 0.5 mg who completed the induction period and were responders at week 8 continued to receive ozanimod 0.5 mg daily in the maintenance period. Participants received 0.5 mg ozanimod capsules daily during the maintenance period (weeks 9 to 32).
11110661|NCT01647516|EG005|Reported Event|Maintenance Period: Ozanimod HCL 1 mg|Participants originally assigned to ozanimod 1 mg who completed the induction period and were responders at week 8 continued to receive ozanimod 0.5 mg daily in the maintenance period. Participants received 1 mg ozanimod capsules daily during the maintenance period (weeks 9 to 32).
11110662|NCT01647516|EG006|Reported Event|Open-Label Treatment Period (OLP): Placebo/Ozanimod|Participants who received placebo capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and receive 1 mg ozanimod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
11110663|NCT01647516|EG007|Reported Event|OLP: Ozanimod 0.5 mg/Ozanimod 1 mg|Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
11110664|NCT01647516|EG008|Reported Event|OLP: Ozanimod 1mg/Ozanimod 1 mg|Participants who received 1 mg ozanimod capsules and completed the induction period and were non-responders at Week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and continue to receive 1 mg ozaninod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
11110665|NCT01647542|BG000|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
11110666|NCT01647542|BG001|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
11110667|NCT01647542|BG002|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
11110668|NCT01647542|BG003|Baseline|Total|Total of all reporting groups
11110669|NCT01647542|FG000|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
11110670|NCT01647542|FG001|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
11110671|NCT01647542|FG002|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
11110672|NCT01647542|OG000|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
11110673|NCT01647542|OG001|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
11110674|NCT01647542|OG002|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
11110675|NCT01647542|EG000|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
11110676|NCT01647542|EG001|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
11110677|NCT01647542|EG002|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
11110678|NCT01647581|BG000|Baseline|Clip|"A clip is been placed at the polypectomy site.~Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size"
11110679|NCT01647581|BG001|Baseline|No Clip|"A hemoclip is not placed at the site of the polypectomy.~NO hemoclip placement: No hemoclip placement (placebo / sham)"
11110680|NCT01647581|BG002|Baseline|Total|Total of all reporting groups
11110681|NCT01647581|FG000|Participant Flow|Clip|"A clip is been placed at the polypectomy site.~Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size"
11110682|NCT01647581|FG001|Participant Flow|No Clip|"A hemoclip is not placed at the site of the polypectomy.~NO hemoclip placement: No hemoclip placement (placebo / sham)"
11110683|NCT01647581|OG000|Outcome|Clip|"A clip is been placed at the polypectomy site.~Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size"
11110684|NCT01647581|OG001|Outcome|No Clip|"A hemoclip is not placed at the site of the polypectomy.~NO hemoclip placement: No hemoclip placement (placebo / sham)"
11110685|NCT01647581|EG000|Reported Event|Clip|"A clip is been placed at the polypectomy site.~Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size"
11110686|NCT01647581|EG001|Reported Event|No Clip|"A hemoclip is not placed at the site of the polypectomy.~NO hemoclip placement: No hemoclip placement (placebo / sham)"
11110687|NCT01647711|BG000|Baseline|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110688|NCT01647711|BG001|Baseline|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110689|NCT01647711|BG002|Baseline|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110690|NCT01647711|BG003|Baseline|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110691|NCT01647711|BG004|Baseline|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110692|NCT01647711|BG005|Baseline|Total|Total of all reporting groups
11110693|NCT01647711|FG000|Participant Flow|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110694|NCT01647711|FG001|Participant Flow|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110695|NCT01647711|FG002|Participant Flow|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110696|NCT01647711|FG003|Participant Flow|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110697|NCT01647711|FG004|Participant Flow|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110698|NCT01647711|OG000|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110699|NCT01647711|OG001|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110700|NCT01647711|OG002|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110701|NCT01647711|OG003|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110702|NCT01647711|OG004|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110703|NCT01647711|OG000|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110704|NCT01647711|EG000|Reported Event|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110705|NCT01647711|EG001|Reported Event|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110706|NCT01647711|EG002|Reported Event|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110707|NCT01647711|EG003|Reported Event|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110708|NCT01647711|EG004|Reported Event|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
11110709|NCT01647711|EG005|Reported Event|All Participants|All treated participants included in the study.
11110710|NCT01647737|BG000|Baseline|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
11110711|NCT01647737|BG001|Baseline|Placebo|"Xylitol~Green tea lozenge: 4-6 times daily"
11110712|NCT01647737|BG002|Baseline|Total|Total of all reporting groups
11110713|NCT01647737|FG000|Participant Flow|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
11110714|NCT01647737|FG001|Participant Flow|Placebo|Xylitol lozenge 4 - 6 times daily
11110715|NCT01647737|OG000|Outcome|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
11110716|NCT01647737|OG001|Outcome|Placebo|Xylitol lozenge 4 - 6 times daily
11110717|NCT01647737|EG000|Reported Event|MighTeaFlow|"4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks~MighTeaFlow: 4-6 times daily"
11110718|NCT01647737|EG001|Reported Event|Xylitol|"4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks~Xylitol: 4-6 times daily"
11110719|NCT01647945|BG000|Baseline|Placebo|Placebo: placebo pill
11110720|NCT01647945|BG001|Baseline|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
11110721|NCT01647945|BG002|Baseline|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
11110722|NCT01647945|BG003|Baseline|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
11110723|NCT01647945|BG004|Baseline|Total|Total of all reporting groups
11110724|NCT01647945|FG000|Participant Flow|Placebo|Placebo: placebo pill
11110725|NCT01647945|FG001|Participant Flow|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
11110726|NCT01647945|FG002|Participant Flow|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
11110727|NCT01647945|FG003|Participant Flow|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
11110728|NCT01647945|OG000|Outcome|Placebo|Placebo: placebo pill
11110729|NCT01647945|OG001|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
11110730|NCT01647945|OG002|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
11110731|NCT01647945|OG003|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
11110732|NCT01647945|EG000|Reported Event|Placebo|Placebo: placebo pill
11110733|NCT01647945|EG001|Reported Event|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
11110734|NCT01647945|EG002|Reported Event|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
11110735|NCT01647945|EG003|Reported Event|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
11110736|NCT01647958|BG000|Baseline|Treatment Arm|"Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.~EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication"
11110737|NCT01647958|BG001|Baseline|Control|Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
11110738|NCT01647958|BG002|Baseline|Total|Total of all reporting groups
11110739|NCT01647958|FG000|Participant Flow|Treatment Arm|"Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.~EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication"
11110740|NCT01647958|FG001|Participant Flow|Control|Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
11110741|NCT01647958|OG000|Outcome|Treatment Arm|"Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.~EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication"
11110742|NCT01647958|OG001|Outcome|Control|Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
11110743|NCT01647958|OG001|Outcome|Control Arm|Participants taking standard dose PPI
11110744|NCT01647958|OG001|Outcome|Control Arm|Participants taking maximum dose PPIs during Initial Study.
11110745|NCT01647958|OG000|Outcome|Treatment Arm|"Transoral incisionless esophagogastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.~EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication"
11110746|NCT01647958|OG001|Outcome|Control Arm|Patients taking standard daily dose of PPIs
11110747|NCT01647958|OG001|Outcome|Control Arm|Patients who received Crossover TIF after 6-month initial study follow-up
11110748|NCT01647958|OG000|Outcome|Treatment Arm|"Transoral incisionless esophagogastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.~EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication~NOTE: This Arm now includes Control arm patients, making one cohort of patients for the Extended Follow up Phase of the study."
11110749|NCT01647958|OG001|Outcome|Control Arm|Patients who received Crossover TIF after 6-month initial study follow-up. NOTE: These patients will be added to the Treatment arm patients to become one cohort of patients for Extended Follow-up Phase.
11110750|NCT01647958|OG001|Outcome|Control Arm|Patients who received Crossover TIF after 6-month initial study follow-up. NOTE: These patients will be added to the Treatment arm patients to become one cohort of patients for Extended Follow-up Phase. The value entered in this section is 0.
11110751|NCT01647958|OG000|Outcome|Treatment Arm|"Transoral incisionless esophagogastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.~EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication~NOTE: This Arm now includes Treatment arm plus Control arm patients, making one cohort of patients for the Extended Follow up Phase of the study."
11110752|NCT01647958|EG000|Reported Event|Treatment Arm|"Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.~EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication"
11110753|NCT01647958|EG001|Reported Event|Control|Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
11110754|NCT01648101|BG000|Baseline|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110755|NCT01648101|BG001|Baseline|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110756|NCT01648101|BG002|Baseline|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110757|NCT01648101|BG003|Baseline|Total|Total of all reporting groups
11126671|NCT01734785|OG000|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11126672|NCT01734785|OG001|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11110758|NCT01648101|FG000|Participant Flow|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110759|NCT01648101|FG001|Participant Flow|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110760|NCT01648101|FG002|Participant Flow|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110761|NCT01648101|OG000|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110762|NCT01648101|OG001|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110763|NCT01648101|OG002|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110764|NCT01648101|OG000|Outcome|Overall Study Arm|
11110765|NCT01648101|OG001|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110766|NCT01648101|OG002|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110767|NCT01648101|OG003|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110768|NCT01648101|EG000|Reported Event|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110769|NCT01648101|EG001|Reported Event|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110770|NCT01648101|EG002|Reported Event|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
11110771|NCT01648140|BG000|Baseline|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
11110772|NCT01648140|BG001|Baseline|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110773|NCT01648140|BG002|Baseline|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110774|NCT01648140|BG003|Baseline|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110775|NCT01648140|BG004|Baseline|Total|Total of all reporting groups
11110776|NCT01648140|FG000|Participant Flow|GSK2336805 40 mg, G1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
11110777|NCT01648140|FG001|Participant Flow|GSK2336805 60 mg, G1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110778|NCT01648140|FG002|Participant Flow|Telaprevir, G1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110779|NCT01648140|FG003|Participant Flow|GSK2336805 60 mg, G4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110780|NCT01648140|OG000|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
11110781|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110782|NCT01648140|OG002|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110783|NCT01648140|OG003|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110784|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110785|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
11110786|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
11110787|NCT01648140|OG000|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.
11110788|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2divided doses with food.
11110789|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.
11110790|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110791|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11126673|NCT01734785|OG002|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11110792|NCT01648140|OG001|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110793|NCT01648140|EG000|Reported Event|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
11110794|NCT01648140|EG001|Reported Event|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110795|NCT01648140|EG002|Reported Event|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110796|NCT01648140|EG003|Reported Event|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
11110797|NCT01648166|BG000|Baseline|Lung Cancer Cases|"subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky~Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia"
11110798|NCT01648166|BG001|Baseline|Control Subjects|"subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky~Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia"
11110799|NCT01648166|BG002|Baseline|Total|Total of all reporting groups
11110800|NCT01648166|FG000|Participant Flow|Lung Cancer Cases|"subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky~Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia"
11110801|NCT01648166|FG001|Participant Flow|Control Subjects|"subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky~Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia"
11110802|NCT01648166|OG000|Outcome|Lung Cancer Cases|"subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky~Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia"
11110803|NCT01648166|OG001|Outcome|Control Subjects|"subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky~Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia"
11110804|NCT01648166|EG000|Reported Event|Lung Cancer Cases|"subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky~Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia"
11110805|NCT01648166|EG001|Reported Event|Control Subjects|"subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky~Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia"
11110806|NCT01648283|BG000|Baseline|Methadone Arm|"Intravenous racemic methadone HCl, 6.0 mg bolus~Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg~racemic methadone HC1: IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg~Oral deuterated racemic methadone HCl,: 11 mg capsule once"
11110807|NCT01648283|FG000|Participant Flow|Methadone Arm|"Intravenous racemic methadone HCl, 6.0 mg bolus~Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg~racemic methadone HC1: IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg~Oral deuterated racemic methadone HCl,: 11 mg capsule once"
11110808|NCT01648283|OG000|Outcome|CYP2B6*1/*1|Oral R-methadone HCl
11110809|NCT01648283|OG001|Outcome|CYP2B6*1/*6|Oral R-methadone
11110810|NCT01648283|OG002|Outcome|CYP2B6*6/*6|Oral R-methadone
11110811|NCT01648283|EG000|Reported Event|Methadone Arm|"Intravenous racemic methadone HCl, 6.0 mg bolus~Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg~racemic methadone HC1: IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg~Oral deuterated racemic methadone HCl,: 11 mg capsule once"
11110812|NCT01648322|BG000|Baseline|80 µg/kg/Dose of F-627|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110813|NCT01648322|BG001|Baseline|240 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110814|NCT01648322|BG002|Baseline|320 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110815|NCT01648322|BG003|Baseline|Neulasta® (Pegfilgrastim)|"Given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
11110816|NCT01648322|BG004|Baseline|Total|Total of all reporting groups
11110817|NCT01648322|FG000|Participant Flow|80 µg/kg/Dose of F-627|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110818|NCT01648322|FG001|Participant Flow|240 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110819|NCT01648322|FG002|Participant Flow|320 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110820|NCT01648322|FG003|Participant Flow|Neulasta® (Pegfilgrastim)|"Given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
11110821|NCT01648322|OG000|Outcome|80 µg/kg/Dose of F-627(TC)|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110822|NCT01648322|OG001|Outcome|240 µg/kg/Dose of F-627 (TC)|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110823|NCT01648322|OG002|Outcome|320 µg/kg/Dose of F-627 (TC)|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110824|NCT01648322|OG003|Outcome|Neulasta® (Pegfilgrastim) (TC)|"Neulasta fixed dose of 6mg given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
11110825|NCT01648322|OG004|Outcome|240 µg/kg/Dose of F-627 (TAC)|"This dose of F-627 given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110826|NCT01648322|OG005|Outcome|320 µg/kg/Dose of F-627 (TAC)|"This dose of F-627 given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110827|NCT01648322|OG006|Outcome|Neulasta® (Pegfilgrastim) (TAC)|"Neulasta fixed dose of 6mg given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110828|NCT01648322|OG000|Outcome|80 µg/kg/Dose of F-627|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110829|NCT01648322|OG001|Outcome|240 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110830|NCT01648322|OG002|Outcome|320 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110831|NCT01648322|OG003|Outcome|Neulasta® (Pegfilgrastim)|"Given to subjects receiving TC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
11110832|NCT01648322|OG004|Outcome|240 µg/kg/Dose of F-627- TAC|"This dose of F-627 given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110833|NCT01648322|OG005|Outcome|320 µg/kg/Dose of F-627 -TAC|"This dose of F-627 given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110834|NCT01648322|OG006|Outcome|Neulasta® (Pegfilgrastim) -TAC|"Given to subjects receiving TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle"
11110835|NCT01648322|OG001|Outcome|240 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110836|NCT01648322|OG002|Outcome|320 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110837|NCT01648322|OG003|Outcome|Neulasta® (Pegfilgrastim)|"Given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
11110838|NCT01648322|OG000|Outcome|240 µg/kg/Dose of F-627- TAC|"This dose of F-627 given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110839|NCT01648322|OG001|Outcome|320 µg/kg/Dose of F-627 -TAC|"This dose of F-627 given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110840|NCT01648322|OG002|Outcome|Neulasta® (Pegfilgrastim) -TAC|"Given to subjects receiving TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle"
11110841|NCT01648322|EG000|Reported Event|80 µg/kg/Dose of F-627|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110842|NCT01648322|EG001|Reported Event|240 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110843|NCT01648322|EG002|Reported Event|320 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
11110844|NCT01648322|EG003|Reported Event|Neulasta® (Pegfilgrastim)|"Neulasta fixed dose of 6mg given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
11110845|NCT01648348|BG000|Baseline|Phase I: Bev + TRC105 (Dose 0-2)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 3/5/7 mg/kg IV) of course 1 and days 1 (as 6/8/10 mg/kg IV)and 8 (as 6/8/10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110846|NCT01648348|BG001|Baseline|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110847|NCT01648348|BG002|Baseline|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110848|NCT01648348|BG003|Baseline|Total|Total of all reporting groups
11110849|NCT01648348|FG000|Participant Flow|Phase I: Bev + TRC105 (Dose 0, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 3 mg/kg IV) of course 1 and days 1 (as 6 mg/kg IV)and 8 (as 6 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110850|NCT01648348|FG001|Participant Flow|Phase I: Bev + TRC105 (Dose 1, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 5 mg/kg IV) of course 1 and days 1 (as 8 mg/kg IV)and 8 (as 8 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110851|NCT01648348|FG002|Participant Flow|Phase I: Bev + TRC105 (Dose 2, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110852|NCT01648348|FG003|Participant Flow|Phase I: Bev + TRC105 (Dose 2, Cohort B)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110853|NCT01648348|FG004|Participant Flow|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110854|NCT01648348|FG005|Participant Flow|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110855|NCT01648348|OG000|Outcome|Phase I: Bev + TRC105 (Dose 0, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 3 mg/kg IV) of course 1 and days 1 (as 6 mg/kg IV)and 8 (as 6 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110856|NCT01648348|OG001|Outcome|Phase I: Bev + TRC105 (Dose 1, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 5 mg/kg IV) of course 1 and days 1 (as 8 mg/kg IV)and 8 (as 8 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110857|NCT01648348|OG002|Outcome|Phase I: Bev + TRC105 (Dose 2, Cohort A + B)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110858|NCT01648348|OG000|Outcome|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110859|NCT01648348|OG001|Outcome|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110860|NCT01648348|EG000|Reported Event|Phase I: Bev + TRC105 (Dose 0, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 3 mg/kg IV) of course 1 and days 1 (as 6 mg/kg IV)and 8 (as 6 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110861|NCT01648348|EG001|Reported Event|Phase I: Bev + TRC105 (Dose 1, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 5 mg/kg IV) of course 1 and days 1 (as 8 mg/kg IV)and 8 (as 8 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110862|NCT01648348|EG002|Reported Event|Phase I: Bev + TRC105 (Dose 2, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110863|NCT01648348|EG003|Reported Event|Phase I: Bev + TRC105 (Dose 2, Cohort B)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110864|NCT01648348|EG004|Reported Event|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110865|NCT01648348|EG005|Reported Event|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
11110866|NCT01648452|BG000|Baseline|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
11110867|NCT01648452|FG000|Participant Flow|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
11110868|NCT01648452|OG000|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
11110869|NCT01648452|OG000|Outcome|Untreated Control Eye|
11110870|NCT01648452|EG000|Reported Event|NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed reflect the primary outcome endpoint of adverse events reported within 6 months post-implantation.
11110871|NCT01648452|EG001|Reported Event|NT-501 CNTF-releasing Implant Events > 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed are adverse events reported after the primary outcome endpoint of 6 months post-implantation.
11110872|NCT01648491|BG000|Baseline|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
11110873|NCT01648491|FG000|Participant Flow|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
11110874|NCT01648491|OG000|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
11110875|NCT01648491|OG000|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
11110876|NCT01648491|EG000|Reported Event|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
11110877|NCT01648530|BG000|Baseline|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
11110878|NCT01648530|FG000|Participant Flow|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
11110879|NCT01648530|OG000|Outcome|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
11110880|NCT01648530|OG000|Outcome|Participants With Episodic Migraine|Participants who returned completed internet survey with Episodic Migraine defined as <15 headache days/month. No intervention was administered in this study.
11110881|NCT01648530|OG001|Outcome|Participants With Chronic Migraine|Participants who returned completed internet survey with Chronic Migraine defined as ≥15 headache days/month. No intervention was administered in this study.
11110882|NCT01648530|EG000|Reported Event|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
11110883|NCT01648582|BG000|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110884|NCT01648582|BG001|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110885|NCT01648582|BG002|Baseline|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110886|NCT01648582|BG003|Baseline|Total|Total of all reporting groups
11110887|NCT01648582|FG000|Participant Flow|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110888|NCT01648582|FG001|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110889|NCT01648582|FG002|Participant Flow|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
11110890|NCT01648582|OG000|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110891|NCT01648582|OG001|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110892|NCT01648582|OG002|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110893|NCT01648582|OG000|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110894|NCT01648582|OG001|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110895|NCT01648582|OG002|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
11110896|NCT01648582|EG000|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110897|NCT01648582|EG001|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
11110898|NCT01648582|EG002|Reported Event|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
11110899|NCT01648699|BG000|Baseline|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
11110900|NCT01648699|FG000|Participant Flow|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
11110901|NCT01648699|OG000|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
11110902|NCT01648699|OG001|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
11110903|NCT01648699|OG002|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
11110904|NCT01648699|OG003|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
11110905|NCT01648699|OG004|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
11110906|NCT01648699|OG005|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
11110907|NCT01648699|OG006|Outcome|OROS Hydromorphone 36 mg|OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
11110908|NCT01648699|OG006|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
11110909|NCT01648699|OG007|Outcome|OROS Hydromorphone (No Dose Indicated)|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
11110910|NCT01648699|OG000|Outcome|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
11110911|NCT01648699|EG000|Reported Event|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
11110912|NCT01648764|BG000|Baseline|40 mg LY - Arm A Dose Escalation|40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110913|NCT01648764|BG001|Baseline|50 mg LY - Arm A Dose Escalation|50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110914|NCT01648764|BG002|Baseline|60 mg LY - Arm A Dose Escalation|60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110915|NCT01648764|BG003|Baseline|70 mg LY - Arm A Dose Escalation|70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28 -ay treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110916|NCT01648764|BG004|Baseline|80 mg LY - Arm A Dose Escalation|80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110917|NCT01648764|BG005|Baseline|90 mg LY - Arm A Dose Escalation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110918|NCT01648764|BG006|Baseline|100 mg LY - Arm A Dose Escalation|100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110919|NCT01648764|BG007|Baseline|40 mg LY - Arm B Dose Escalation|40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110920|NCT01648764|BG008|Baseline|50 mg LY - Arm B Dose Escalation|50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110921|NCT01648764|BG009|Baseline|60 mg LY - Arm B Dose Escalation|60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110922|NCT01648764|BG010|Baseline|70 mg LY - Arm B Dose Escalation|70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110923|NCT01648764|BG011|Baseline|80 mg LY - Arm B Dose Escalation|80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110924|NCT01648764|BG012|Baseline|90 mg LY - Arm B Dose Escalation|90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110925|NCT01648764|BG013|Baseline|90 mg LY2334737 - Arm A Dose Confirmation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110926|NCT01648764|BG014|Baseline|Total|Total of all reporting groups
11110927|NCT01648764|FG000|Participant Flow|40 mg LY - Arm A Dose Escalation|40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110928|NCT01648764|FG001|Participant Flow|50 mg LY - Arm A Dose Escalation|50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110929|NCT01648764|FG002|Participant Flow|60 mg LY - Arm A Dose Escalation|60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110930|NCT01648764|FG003|Participant Flow|70 mg LY - Arm A Dose Escalation|70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110931|NCT01648764|FG004|Participant Flow|80 mg LY - Arm A Dose Escalation|80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110932|NCT01648764|FG005|Participant Flow|90 mg LY - Arm A Dose Escalation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110933|NCT01648764|FG006|Participant Flow|100 mg LY - Arm A Dose Escalation|100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110934|NCT01648764|FG007|Participant Flow|40 mg LY - Arm B Dose Escalation|40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110935|NCT01648764|FG008|Participant Flow|50 mg LY - Arm B Dose Escalation|50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110936|NCT01648764|FG009|Participant Flow|60 mg LY - Arm B Dose Escalation|60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110937|NCT01648764|FG010|Participant Flow|70 mg LY - Arm B Dose Escalation|70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110938|NCT01648764|FG011|Participant Flow|80 mg LY - Arm B Dose Escalation|80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110939|NCT01648764|FG012|Participant Flow|90 mg LY - Arm B Dose Escalation|90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110940|NCT01648764|FG013|Participant Flow|90 mg LY - Arm A Dose Confirmation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110941|NCT01648764|OG000|Outcome|LY2334737|LY2334737 was administered as 2 Arms A and B. Participants in treatment Arm A were administered LY2334737 orally in escalating doses of 40 to 100 milligrams (mg) of LY2334737 every other day for 21 days followed by 7 days without study drug. Participants in treatment Arm B were administered LY2334737 orally in escalating doses of 40 to 90 mg every day for 7 days followed by 7 days without study drug and then repeated. Both treatment cycles were 28 days.
11110942|NCT01648764|OG000|Outcome|40 mg LY - Arm A Dose Escalation|40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110943|NCT01648764|OG001|Outcome|50 mg LY - Arm A Dose Escalation|50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110944|NCT01648764|OG002|Outcome|60 mg LY - Arm A Dose Escalation|60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110945|NCT01648764|OG003|Outcome|70 mg LY - Arm A Dose Escalation|70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110946|NCT01648764|OG004|Outcome|80 mg LY - Arm A Dose Escalation|80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110947|NCT01648764|OG005|Outcome|90 mg LY - Arm A Dose Escalation and Dose Confirmation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110948|NCT01648764|OG006|Outcome|100 mg LY - Arm A Dose Escalation|100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110949|NCT01648764|OG007|Outcome|40 mg LY - Arm B Dose Escalation|40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110950|NCT01648764|OG008|Outcome|50 mg LY - Arm B Dose Escalation|50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110951|NCT01648764|OG009|Outcome|60 mg LY - Arm B Dose Escalation|60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110952|NCT01648764|OG010|Outcome|70 mg LY - Arm B Dose Escalation|70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110953|NCT01648764|OG011|Outcome|80 mg LY - Arm B Dose Escalation|80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110954|NCT01648764|OG012|Outcome|90 mg LY - Arm B Dose Escalation|90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110955|NCT01648764|OG000|Outcome|40 mg LY - Arm A Dose Escalation|40 milligram (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110956|NCT01648764|OG005|Outcome|90 mg LY - Arm A Dose Escalation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110957|NCT01648764|OG013|Outcome|90 mg LY - Arm A Dose Confirmation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110958|NCT01648764|OG013|Outcome|90 mg LY - Arm A Dose Confirmation|90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110959|NCT01648764|EG000|Reported Event|40 mg LY - Arm A Dose Escalation|40 milligrams (mg) LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110960|NCT01648764|EG001|Reported Event|50 mg LY - Arm A Dose Escalation|50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110961|NCT01648764|EG002|Reported Event|60 mg LY - Arm A Dose Escalation|60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110962|NCT01648764|EG003|Reported Event|70 mg LY - Arm A Dose Escalation|70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110963|NCT01648764|EG004|Reported Event|80 mg LY - Arm A Dose Escalation|80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110964|NCT01648764|EG005|Reported Event|90 mg LY - Arm A Dose Escalation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110965|NCT01648764|EG006|Reported Event|100 mg LY - Arm A Dose Escalation|100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110966|NCT01648764|EG007|Reported Event|40 mg LY - Arm B Dose Escalation|40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110967|NCT01648764|EG008|Reported Event|50 mg LY - Arm B Dose Escalation|50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110968|NCT01648764|EG009|Reported Event|60 mg LY - Arm B Dose Escalation|60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110969|NCT01648764|EG010|Reported Event|70 mg LY - Arm B Dose Escalation|70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110970|NCT01648764|EG011|Reported Event|80 mg LY - Arm B Dose Escalation|80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110971|NCT01648764|EG012|Reported Event|90 mg LY - Arm B Dose Escalation|90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110972|NCT01648764|EG013|Reported Event|90 mg LY - Arm A Dose Confirmation|90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
11110973|NCT01648790|BG000|Baseline|All Participants|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® formulation (ODT1) or orally disintegrating tablet containing Magnasweet® formulation (ODT2) given either on top of tongue or dispersed in water administered in either the fasted or fed state. 2 mg prasugrel ODT2 given on top of tongue in the fasted state.
11110974|NCT01648790|FG000|Participant Flow|Sequence 1|Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast
11110975|NCT01648790|FG001|Participant Flow|Sequence 2|Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed
11110976|NCT01648790|FG002|Participant Flow|Sequence 3|Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast
11110977|NCT01648790|FG003|Participant Flow|Sequence 4|Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast
11110978|NCT01648790|FG004|Participant Flow|Sequence 5|Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast
11110979|NCT01648790|OG000|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
11110980|NCT01648790|OG001|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
11110981|NCT01648790|OG002|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
11110982|NCT01648790|OG003|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
11110983|NCT01648790|OG004|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
11110984|NCT01648790|EG000|Reported Event|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
11110985|NCT01648790|EG001|Reported Event|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
11110986|NCT01648790|EG002|Reported Event|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
11110987|NCT01648790|EG003|Reported Event|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
11110988|NCT01648790|EG004|Reported Event|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
10848761|NCT00291343|EG001|Reported Event|Tritanrix-HepB/Hiberix+Mencevax ACWY Group|Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
11110989|NCT01648920|BG000|Baseline|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
11126674|NCT01734785|EG000|Reported Event|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11110990|NCT01648920|FG000|Participant Flow|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
11110991|NCT01648920|OG000|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
11110992|NCT01648920|EG000|Reported Event|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
11110993|NCT01648959|BG000|Baseline|Dexmedetomidine Infusion and iEEG Activity|"5 patients included in this study underwent bi-temporal implantation, and were shown to have unilateral hippocampal seizure onsets.~iEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose."
11110994|NCT01648959|FG000|Participant Flow|iEEG Activity|iEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose.
11110995|NCT01648959|OG000|Outcome|iEEG Activity|Data are presented as power spectral density, also referred to as the power spectrum or spectrum which quantifies the frequency distribution of energy or power within a signal.
11110996|NCT01648959|EG000|Reported Event|iEEG Activity|iEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose.
11110997|NCT01649180|BG000|Baseline|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
11110998|NCT01649180|FG000|Participant Flow|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
11110999|NCT01649180|OG000|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
11111000|NCT01649180|EG000|Reported Event|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
11111001|NCT01649232|BG000|Baseline|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
11111002|NCT01649232|BG001|Baseline|Controls|Healthy people that not receive tDCS
11111003|NCT01649232|BG002|Baseline|Total|Total of all reporting groups
11111004|NCT01649232|FG000|Participant Flow|Active tDCS|"Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days.~55 % of subjects led the anode in temporal lobe (60% right temporal lobe and 40% in left temporal lobe). 8 % of subjects led de anode in parietal lobe (80 % in left hemisphere), and the rest of subjets 37 % of them led the anodo in frontal and prefrontal lobe (55 % in right frontal lobe and 45 % in left frontal lobe)."
11111005|NCT01649232|FG001|Participant Flow|Controls|Healthy people that not receive tDCS
11111006|NCT01649232|OG000|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
11111007|NCT01649232|OG001|Outcome|Control Group|Healthy people that not receive tDCS
11111008|NCT01649232|OG001|Outcome|Controls|Healthy people that not receive tDCS
11111009|NCT01649232|OG002|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
11111010|NCT01649232|OG003|Outcome|Controls at 3 Months|Healthy people that not receive tDCS
11111011|NCT01649232|OG003|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
11111012|NCT01649232|OG000|Outcome|Active tDCS Group|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
11111013|NCT01649232|OG002|Outcome|Active tDCS at 3 Months|l Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
11111014|NCT01649232|EG000|Reported Event|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
11111015|NCT01649232|EG001|Reported Event|Controls|Healthy people that not receive tDCS
11111016|NCT01649271|BG000|Baseline|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111017|NCT01649271|BG001|Baseline|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111018|NCT01649271|BG002|Baseline|Total|Total of all reporting groups
11111019|NCT01649271|FG000|Participant Flow|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111020|NCT01649271|FG001|Participant Flow|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111021|NCT01649271|OG000|Outcome|Phase Ia: Afatinib +Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111022|NCT01649271|OG000|Outcome|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111023|NCT01649271|OG001|Outcome|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111024|NCT01649271|EG000|Reported Event|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111025|NCT01649271|EG001|Reported Event|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
11111026|NCT01649297|BG000|Baseline|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
11111027|NCT01649297|BG001|Baseline|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
11111028|NCT01649297|BG002|Baseline|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
11111029|NCT01649297|BG003|Baseline|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
11111030|NCT01649297|BG004|Baseline|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
11111031|NCT01649297|BG005|Baseline|Total|Total of all reporting groups
11111032|NCT01649297|FG000|Participant Flow|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
11111033|NCT01649297|FG001|Participant Flow|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
11111034|NCT01649297|FG002|Participant Flow|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
11111035|NCT01649297|FG003|Participant Flow|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
11111036|NCT01649297|FG004|Participant Flow|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
11111037|NCT01649297|OG000|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
11111038|NCT01649297|OG001|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
11111039|NCT01649297|OG002|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
11111040|NCT01649297|OG003|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
11111041|NCT01649297|OG004|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
11111042|NCT01649297|EG000|Reported Event|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
11111043|NCT01649297|EG001|Reported Event|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
11111044|NCT01649297|EG002|Reported Event|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
11111045|NCT01649297|EG003|Reported Event|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
11111046|NCT01649297|EG004|Reported Event|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
11111047|NCT01649362|BG000|Baseline|Control Group|no prefeeding oral stimulation
11111048|NCT01649362|BG001|Baseline|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
11111049|NCT01649362|BG002|Baseline|Total|Total of all reporting groups
11111050|NCT01649362|FG000|Participant Flow|Control Group|no prefeeding oral stimulation
11111051|NCT01649362|FG001|Participant Flow|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
11111052|NCT01649362|OG000|Outcome|Control Group|no prefeeding oral stimulation
11111053|NCT01649362|OG001|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
11111054|NCT01649362|EG000|Reported Event|Control Group|no prefeeding oral stimulation
11111055|NCT01649362|EG001|Reported Event|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
11111056|NCT01649375|BG000|Baseline|Secukinumab 75 mg|Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
11111057|NCT01649375|BG001|Baseline|Secukinumab 150 mg|Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
11111058|NCT01649375|BG002|Baseline|Placebo|Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
11111059|NCT01649375|BG003|Baseline|Total|Total of all reporting groups
11111060|NCT01649375|FG000|Participant Flow|Secukinumab 75 mg|Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
11111061|NCT01649375|FG001|Participant Flow|Secukinumab 150 mg|Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
11111062|NCT01649375|FG002|Participant Flow|Placebo|Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
11111063|NCT01649375|FG003|Participant Flow|Placebo - Secukinumab 75 mg|Placebo patients re-randomized to secukinumab 75 mg subcutaneous injection every 4 weeks starting from week 16.
11111064|NCT01649375|FG004|Participant Flow|Placebo - Secukinumab 150 mg|Placebo patients re-randomized to secukinumab 150 mg subcutaneous injection every 4 weeks starting from week 16.
11111065|NCT01649375|OG000|Outcome|Secukinumab 75 mg|Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
11111066|NCT01649375|OG001|Outcome|Secukinumab 150 mg|Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
11111067|NCT01649375|OG002|Outcome|Placebo|Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
11111068|NCT01649375|EG000|Reported Event|Any Secukinumab 75 mg|Includes patients originally randomized to secukinumab 75 mg at baseline and placebo patients who were re-randomized to secukinumab 75 mg at week 16 (AEs occurring after re-randomization).
11111069|NCT01649375|EG001|Reported Event|Any Secukinumab 150 mg|Includes patients originally randomized to secukinumab 150 mg at baseline, placebo patients re-randomized to secukinumab 150 mg at Week 16 (AEs occuring after re-randomization) and patients who up-titrated from secukinumab 75 mg to 150 mg (AEs occurring after up-titration).
11111070|NCT01649375|EG002|Reported Event|Placebo|Includes patients originally randomized to Placebo for AEs until the time of re-randomization (Week 16) to Secukinumab
11111071|NCT01649427|BG000|Baseline|Tacrolimus Hexal®|Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
11111072|NCT01649427|BG001|Baseline|Prograf®|Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
11111073|NCT01649427|BG002|Baseline|Total|Total of all reporting groups
11111074|NCT01649427|FG000|Participant Flow|Tacrolimus Hexal®|Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
11111075|NCT01649427|FG001|Participant Flow|Prograf®|Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
11111076|NCT01649427|OG000|Outcome|Tacrolimus Hexal®|Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
11111077|NCT01649427|OG001|Outcome|Prograf®|Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
11111078|NCT01649427|EG000|Reported Event|Tacrolimus Hexal|Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
11111079|NCT01649427|EG001|Reported Event|Prograf|Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
11111080|NCT01649557|BG000|Baseline|Prior Brexiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111081|NCT01649557|BG001|Baseline|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111082|NCT01649557|BG002|Baseline|Prior Apripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111083|NCT01649557|BG003|Baseline|Total|Total of all reporting groups
11111084|NCT01649557|FG000|Participant Flow|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111085|NCT01649557|FG001|Participant Flow|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111086|NCT01649557|FG002|Participant Flow|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111087|NCT01649557|OG000|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111088|NCT01649557|OG001|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111089|NCT01649557|OG002|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111090|NCT01649557|EG000|Reported Event|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111091|NCT01649557|EG001|Reported Event|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111092|NCT01649557|EG002|Reported Event|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
11111093|NCT01649596|BG000|Baseline|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
11111094|NCT01649596|BG001|Baseline|Control|"Standard of care, warm blankets~Standard of care - warm blankets"
11111095|NCT01649596|BG002|Baseline|Total|Total of all reporting groups
11111096|NCT01649596|FG000|Participant Flow|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
11111097|NCT01649596|FG001|Participant Flow|Control|Standard of care warm blankets
11111098|NCT01649596|OG000|Outcome|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
11111099|NCT01649596|OG001|Outcome|Control|Standard of care warm blankets
11111100|NCT01649596|EG000|Reported Event|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
11111101|NCT01649596|EG001|Reported Event|Control|Standard of care warm blankets
11111102|NCT01649609|BG000|Baseline|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
11111103|NCT01649609|BG001|Baseline|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
11111104|NCT01649609|BG002|Baseline|Total|Total of all reporting groups
11111105|NCT01649609|FG000|Participant Flow|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
11111106|NCT01649609|FG001|Participant Flow|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
11111107|NCT01649609|OG000|Outcome|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
11111108|NCT01649609|OG001|Outcome|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
11111109|NCT01649609|EG000|Reported Event|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
11111110|NCT01649609|EG001|Reported Event|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
11111111|NCT01649765|BG000|Baseline|Placebo|Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care
11111112|NCT01649765|BG001|Baseline|Belimumab 10 mg/kg|Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
11111113|NCT01649765|BG002|Baseline|Total|Total of all reporting groups
11111114|NCT01649765|FG000|Participant Flow|Placebo|Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
11111115|NCT01649765|FG001|Participant Flow|Belimumab 10 mg/kg|Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
11111116|NCT01649765|OG000|Outcome|Placebo|Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
11111117|NCT01649765|OG001|Outcome|Belimumab 10 mg/kg|Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
11111118|NCT01649765|OG000|Outcome|Belimumab 10 mg/kg|Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
11111119|NCT01649765|EG000|Reported Event|Placebo|Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care
11111120|NCT01649765|EG001|Reported Event|Belimumab 10 mg/kg|Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
11111121|NCT01649791|BG000|Baseline|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
11111122|NCT01649791|FG000|Participant Flow|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
11111123|NCT01649791|OG000|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
11111124|NCT01649791|EG000|Reported Event|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
11111125|NCT01649804|BG000|Baseline|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
11111126|NCT01649804|FG000|Participant Flow|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
11111127|NCT01649804|OG000|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
11111128|NCT01649804|EG000|Reported Event|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
11111129|NCT01649856|BG000|Baseline|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
11111130|NCT01649856|BG001|Baseline|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
11111131|NCT01649856|BG002|Baseline|Total|Total of all reporting groups
11126675|NCT01734785|EG001|Reported Event|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
11126676|NCT01734785|EG002|Reported Event|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
10848762|NCT00291447|BG000|Baseline|Cohort 1|"Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11111132|NCT01649856|FG000|Participant Flow|Rituximab Subcutaneous (SC)|Participants with previously untreated, cluster of differentiation (CD) 20-positive diffuse large B-cell lymphoma (DLBCL) received up to 8 cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 milligrams per meter-squared (mg/m^2) via IV infusion; subsequent doses were given as 1400 milligrams (mg) via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved complete response (CR) or complete response unconfirmed (CRu) after 4 cycles, but all participants received a full 8 cycles of rituximab.
11111133|NCT01649856|FG001|Participant Flow|Rituximab Intravenous (IV)|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
11111134|NCT01649856|OG000|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
11111135|NCT01649856|OG001|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
11111136|NCT01649856|EG000|Reported Event|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
11111137|NCT01649856|EG001|Reported Event|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
11111138|NCT01649869|BG000|Baseline|Placebo|"27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks~Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks"
11111139|NCT01649869|BG001|Baseline|Active|"27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks~Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks."
11111140|NCT01649869|BG002|Baseline|Total|Total of all reporting groups
11111141|NCT01649869|FG000|Participant Flow|Placebo|"27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks~Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks"
11111142|NCT01649869|FG001|Participant Flow|Active|"27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks~Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks."
11111143|NCT01649869|OG000|Outcome|Placebo|"27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks~Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks"
11111144|NCT01649869|OG001|Outcome|Active|"27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks~Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks."
11111145|NCT01649869|OG000|Outcome|Randomized Group|Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
11111146|NCT01649869|OG000|Outcome|Randomized Group|Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir orally twice a day for 6 weeks
11111147|NCT01649869|EG000|Reported Event|Placebo|"27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks~Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks"
11111148|NCT01649869|EG001|Reported Event|Active|"27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks~Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks."
11111149|NCT01649947|BG000|Baseline|Cohort 1: Bevacizumab Eligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine will be given as a"
11111150|NCT01649947|BG001|Baseline|Cohort 2: Bevacizumab Ineligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily"
11111151|NCT01649947|BG002|Baseline|Total|Total of all reporting groups
11111152|NCT01649947|FG000|Participant Flow|Cohort 1: Bevacizumab Eligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine will be given as a"
11111153|NCT01649947|FG001|Participant Flow|Cohort 2: Bevacizumab Ineligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily"
11111154|NCT01649947|OG000|Outcome|Cohort 2: Bevacizumab Ineligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel was given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily)"
11111155|NCT01649947|OG001|Outcome|Cohort 1: Bevacizumab Eligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel was given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine 600 mg BID"
11126677|NCT01734785|EG003|Reported Event|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
11111156|NCT01649947|OG000|Outcome|Cohort 2: Bevacizumab Ineligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel was given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID."
11111157|NCT01649947|EG000|Reported Event|Cohort 1: Bevacizumab Eligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine will be given as a"
11111158|NCT01649947|EG001|Reported Event|Cohort 2: Bevacizumab Ineligible Patients|"Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID~Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).~Cycles every 3 weeks for 4-6 Cycles.~Prior to receiving paclitaxel, all patients will receive the following premedication:~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)~Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.~Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily"
11111159|NCT01650194|BG000|Baseline|Enzalutamide + Abiraterone + Prednisone|Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
11111160|NCT01650194|FG000|Participant Flow|Enzalutamide + Abiraterone + Prednisone|Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
11111161|NCT01650194|OG000|Outcome|Enzalutamide + Abiraterone + Prednisone|Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
11111162|NCT01650194|OG000|Outcome|Enzalutamide + Abiraterone + Prednisone|Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily. DHT bone data were not collected.
11111163|NCT01650194|EG000|Reported Event|Enzalutamide + Abiraterone + Prednisone|Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
11111164|NCT01650246|BG000|Baseline|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
11111165|NCT01650246|FG000|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
11111166|NCT01650246|OG000|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
11111167|NCT01650246|EG000|Reported Event|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
11111168|NCT01650259|BG000|Baseline|Trazenta® Tablets|Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
11111169|NCT01650259|BG001|Baseline|Other OAD|Patients with type 2 diabetes mellitus who were treated with any other oral antidiabetic monotherapy except Trazenta® tablets
11111170|NCT01650259|BG002|Baseline|Total|Total of all reporting groups
11111171|NCT01650259|FG000|Participant Flow|Trazenta® Tablets|Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
11111172|NCT01650259|FG001|Participant Flow|Other OAD|Patients with type 2 diabetes mellitus who were treated with any other oral antidiabetic monotherapy except Trazenta® tablets
11111173|NCT01650259|OG000|Outcome|Trazenta® Tablets|Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
11111174|NCT01650259|EG000|Reported Event|Trazenta® Tablets|Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation.
11126678|NCT01734811|BG000|Baseline|Placebo|"The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation~Biological vaccine: daily spray (2 puff of 100 µL) for six months"
11126679|NCT01734811|BG001|Baseline|Biological Vaccine|"The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation~Biological vaccine: daily spray (2 puff of 100 µL) for six months"
11126680|NCT01734811|BG002|Baseline|Total|Total of all reporting groups
11126681|NCT01734811|FG000|Participant Flow|Placebo|"The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation~Biological vaccine: daily spray (2 puff of 100 µL) for six months"
10846005|NCT00272168|EG001|Reported Event|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
11111175|NCT01650298|BG000|Baseline|Control|Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor.
11111176|NCT01650298|BG001|Baseline|Tailored Anticoagulation|"Tailored Anticoagulation (TAC): Anticoagulation to be stopped/started per device information. Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed.~Drug (Direct thrombin or Factor Xa inhibitor): Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden)."
11111177|NCT01650298|BG002|Baseline|Total|Total of all reporting groups
11111178|NCT01650298|FG000|Participant Flow|Anticoagulation Taken as Prescribed by Doctor|Anticoagulation presciption will be taken per physician's discretion
11111179|NCT01650298|FG001|Participant Flow|Anticoagulation to be Stopped/Started Per Device Information|"Other: The physician will manage the patient's anticoagulation medication by weekly remote monitoring device transmissions~Drug (Direct thrombin or Factor Xa inhibitor): Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden)."
11111180|NCT01650298|OG000|Outcome|Control|Anticoagulation medication was per doctor's discretion / standard of care (continuous coagulation)
11111181|NCT01650298|OG001|Outcome|Tailored Anticoagulation|Anticoagulation medication was based on patient's AT/AF information from device
11111182|NCT01650298|EG000|Reported Event|Anticoagulation Taken as Prescribed by Doctor|Anticoagulation medication was per doctor's discretion
11111183|NCT01650298|EG001|Reported Event|Anticoagulation to be Stopped/Started Per Device Information|Anticoagulation medication was based on patient's AT/AF information from device
11111184|NCT01650324|BG000|Baseline|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
11111185|NCT01650324|BG001|Baseline|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
11111186|NCT01650324|BG002|Baseline|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
11111187|NCT01650324|BG003|Baseline|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
11111188|NCT01650324|BG004|Baseline|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
11111189|NCT01650324|BG005|Baseline|Total|Total of all reporting groups
11111190|NCT01650324|FG000|Participant Flow|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
11111191|NCT01650324|FG001|Participant Flow|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
11111192|NCT01650324|FG002|Participant Flow|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
11111193|NCT01650324|FG003|Participant Flow|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
11111194|NCT01650324|FG004|Participant Flow|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
11111195|NCT01650324|OG000|Outcome|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
11111196|NCT01650324|OG001|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
11111197|NCT01650324|OG002|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
11111198|NCT01650324|OG003|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
11111199|NCT01650324|OG004|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
11111200|NCT01650324|OG000|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
11111201|NCT01650324|OG001|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
11111202|NCT01650324|OG002|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
11111203|NCT01650324|OG003|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
11111204|NCT01650324|OG000|Outcome|Placebo|Participants received a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg or 600 mg.
10846006|NCT00272311|BG000|Baseline|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
10846007|NCT00272311|BG001|Baseline|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
11111205|NCT01650324|EG000|Reported Event|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
11111206|NCT01650324|EG001|Reported Event|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
11111207|NCT01650324|EG002|Reported Event|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
11111208|NCT01650324|EG003|Reported Event|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
11111209|NCT01650324|EG004|Reported Event|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
11111210|NCT01650402|BG000|Baseline|Intensive|"Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg~Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg"
11111211|NCT01650402|BG001|Baseline|Standard|"Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg~Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg"
11111212|NCT01650402|BG002|Baseline|Total|Total of all reporting groups
11111213|NCT01650402|FG000|Participant Flow|Intensive|"Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg~Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg"
11111214|NCT01650402|FG001|Participant Flow|Standard|"Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg~Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg"
11111215|NCT01650402|OG000|Outcome|Intensive|"Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg~Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg"
11111216|NCT01650402|OG001|Outcome|Standard|"Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg~Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg"
11111217|NCT01650402|EG000|Reported Event|Intensive|"Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg~Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg"
11111218|NCT01650402|EG001|Reported Event|Standard|"Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg~Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg"
11111219|NCT01650519|BG000|Baseline|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
11111220|NCT01650519|BG001|Baseline|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
11111221|NCT01650519|BG002|Baseline|Total|Total of all reporting groups
11111222|NCT01650519|FG000|Participant Flow|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
11111223|NCT01650519|FG001|Participant Flow|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
11111224|NCT01650519|OG000|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
11111225|NCT01650519|OG001|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
11111226|NCT01650519|EG000|Reported Event|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
11111227|NCT01650519|EG001|Reported Event|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
11111228|NCT01650545|BG000|Baseline|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
11111229|NCT01650545|BG001|Baseline|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
11111230|NCT01650545|BG002|Baseline|Total|Total of all reporting groups
11111231|NCT01650545|FG000|Participant Flow|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
11111232|NCT01650545|FG001|Participant Flow|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
11111233|NCT01650545|OG000|Outcome|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
11111234|NCT01650545|OG001|Outcome|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
11111235|NCT01650545|OG000|Outcome|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug~Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin"
11111236|NCT01650545|OG001|Outcome|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone.~Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well.~standard immune suppression, oral: conventional drug~Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin"
11111237|NCT01650545|EG000|Reported Event|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
11111238|NCT01650545|EG001|Reported Event|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
11111239|NCT01650558|BG000|Baseline|Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis|Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
11111240|NCT01650558|BG001|Baseline|Chloroquine (CQ) Prophylaxis|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg..
11111241|NCT01650558|BG002|Baseline|Discontinuation of Standard of Care (Control Arm)|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
11111242|NCT01650558|BG003|Baseline|Total|Total of all reporting groups
11111243|NCT01650558|FG000|Participant Flow|Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis|Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
11111244|NCT01650558|FG001|Participant Flow|Chloroquine (CQ) Prophylaxis|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
11111245|NCT01650558|FG002|Participant Flow|Discontinuation of Standard of Care (Control Arm)|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
11111246|NCT01650558|OG000|Outcome|Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis|Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
11111247|NCT01650558|OG001|Outcome|Chloroquine (CQ) Prophylaxis|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
11111248|NCT01650558|OG002|Outcome|Discontinuation of Standard of Care (Control Arm)|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
11111249|NCT01650558|OG001|Outcome|Chloroquine (CQ) Prophylaxis|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg..
11111250|NCT01650558|EG000|Reported Event|Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis|Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).
11111251|NCT01650558|EG001|Reported Event|Chloroquine (CQ) Prophylaxis|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.
11111252|NCT01650558|EG002|Reported Event|Discontinuation of Standard of Care (Control Arm)|Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.
11111253|NCT01650584|BG000|Baseline|ISTA Tears|"Sterile ophthalmic solution~ISTA Tears: sterile ophthalmic solution used in the right eye"
11111254|NCT01650584|BG001|Baseline|Systane|"Sterile ophthalmic solution~Systane: Sterile ophthalmic solution used in the left eye"
10846008|NCT00272311|BG002|Baseline|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
11111255|NCT01650584|BG002|Baseline|Total|Total of all reporting groups
11111256|NCT01650584|FG000|Participant Flow|Overall|Each participant has 2 eyes. There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total).
11111257|NCT01650584|OG000|Outcome|Overall Participants|
11111258|NCT01650584|EG000|Reported Event|ISTA Tears|"Sterile ophthalmic solution~ISTA Tears: sterile ophthalmic solution used in the right eye"
11111259|NCT01650584|EG001|Reported Event|Systane|"Sterile ophthalmic solution~Systane: Sterile ophthalmic solution used in the left eye"
11111260|NCT01650636|BG000|Baseline|Cognitive Behavioral Stress Management|Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
11111261|NCT01650636|BG001|Baseline|Health Information|Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
11111262|NCT01650636|BG002|Baseline|Total|Total of all reporting groups
11111263|NCT01650636|FG000|Participant Flow|Cognitive Behavioral Stress Management|Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
11111264|NCT01650636|FG001|Participant Flow|Health Information|Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
11111265|NCT01650636|OG000|Outcome|Cognitive Behavioral Stress Management|Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
11111266|NCT01650636|OG001|Outcome|Health Information|Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
11111267|NCT01650636|EG000|Reported Event|Cognitive Behavioral Stress Management|Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
11111268|NCT01650636|EG001|Reported Event|Health Information|Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
11111269|NCT01650779|BG000|Baseline|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
11111270|NCT01650779|FG000|Participant Flow|Agalsidase Beta|Commercially available agalsidase beta (Fabrazyme ®) 1.0 milligram per kilogram (mg/kg) administered as an intravenous infusion every 2 weeks (q2w) up to Month 6.
11111271|NCT01650779|OG000|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
11111272|NCT01650779|EG000|Reported Event|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion every 2 weeks up to Month 6.
11111273|NCT01650805|BG000|Baseline|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
11111274|NCT01650805|BG001|Baseline|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
11111275|NCT01650805|BG002|Baseline|Total|Total of all reporting groups
11111276|NCT01650805|FG000|Participant Flow|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
11111277|NCT01650805|FG001|Participant Flow|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
11111278|NCT01650805|OG000|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
11111279|NCT01650805|OG001|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
11111280|NCT01650805|EG000|Reported Event|Ponatinib 45 mg|ponatinib: 45 mg tablet, taken orally once daily
11111281|NCT01650805|EG001|Reported Event|Imatinib 400 mg|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
11111282|NCT01650831|BG000|Baseline|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
11111283|NCT01650831|FG000|Participant Flow|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
11111284|NCT01650831|OG000|Outcome|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
11111285|NCT01650831|OG000|Outcome|Marketed BreathID Positive|Cleared BreathID subjects that were found to be positive for H.pylori
11111286|NCT01650831|OG001|Outcome|Marketed BreathID Negative|Cleared BreathID subjects that were found to be negative for H.pylori
11111287|NCT01650831|OG000|Outcome|Positive Modified BreathID|The amount of subjects that produced positive results for H.pylori with modified BreathID.
11111288|NCT01650831|OG001|Outcome|Negative Modified BreathID|The amount of subjects that produced negative results for H.pylori with modified BreathID.
11111289|NCT01650831|EG000|Reported Event|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
11111290|NCT01650844|BG000|Baseline|School-based Telemedicine Enhanced Asthma Mangement Group|"We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.~School-Based Telemedicine Enhanced Asthma Management"
11111291|NCT01650844|BG001|Baseline|Enhanced Usual Care Group|"Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.~Enhanced Usual Care"
11111292|NCT01650844|BG002|Baseline|Total|Total of all reporting groups
11126682|NCT01734811|FG001|Participant Flow|Biological Vaccine|"The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation~Biological vaccine: daily spray (2 puff of 100 µL) for six months"
11111293|NCT01650844|FG000|Participant Flow|School-based Telemedicine Enhanced Asthma Mangement Group|"We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.~School-Based Telemedicine Enhanced Asthma Management"
11111294|NCT01650844|FG001|Participant Flow|Enhanced Usual Care Group|"Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.~Enhanced Usual Care"
11111295|NCT01650844|OG000|Outcome|School-based Telemedicine Enhanced Asthma Mangement Group|"We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.~School-Based Telemedicine Enhanced Asthma Management"
11111296|NCT01650844|OG001|Outcome|Enhanced Usual Care Group|"Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.~Enhanced Usual Care"
11111297|NCT01650844|EG000|Reported Event|School-based Telemedicine Enhanced Asthma Mangement Group|"We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.~School-Based Telemedicine Enhanced Asthma Management"
11111298|NCT01650844|EG001|Reported Event|Enhanced Usual Care Group|"Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.~Enhanced Usual Care"
11111299|NCT01651000|BG000|Baseline|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11111300|NCT01651000|BG001|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11111301|NCT01651000|BG002|Baseline|Total|Total of all reporting groups
11111302|NCT01651000|FG000|Participant Flow|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11111303|NCT01651000|FG001|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11111304|NCT01651000|OG000|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11111305|NCT01651000|OG001|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11111306|NCT01651000|EG000|Reported Event|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11111307|NCT01651000|EG001|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11111308|NCT01651039|BG000|Baseline|Panobinostat, Lenalidomide and Dexamethasone|"All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.~Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15."
11111309|NCT01651039|FG000|Participant Flow|Panobinostat, Lenalidomide and Dexamethasone|"All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.~Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15."
11111310|NCT01651039|OG000|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
11111311|NCT01651039|EG000|Reported Event|All Subjects|Adverse events collected for all subjects who signed consent.
11111312|NCT01651052|BG000|Baseline|Aortic Bioprosthesis, Model 11000|"Aortic valve replacement therapy~Heart Valve Surgery: Implant of an aortic valve, Model 11000"
11111313|NCT01651052|FG000|Participant Flow|Aortic Bioprosthesis, Model 11000|"Aortic valve replacement therapy~Heart Valve Surgery: Implant of an aortic valve, Model 11000"
11111314|NCT01651052|OG000|Outcome|Aortic Bioprosthesis, Model 11000|"Aortic valve replacement therapy~Heart Valve Surgery: Implant of an aortic valve, Model 11000"
11111315|NCT01651052|EG000|Reported Event|Aortic Bioprosthesis, Model 11000|"Aortic valve replacement therapy~Heart Valve Surgery: Implant of an aortic valve, Model 11000"
11111316|NCT01651078|BG000|Baseline|Main Cohort|Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who already scheduled for NeuroBlate procedure.
11111317|NCT01651078|FG000|Participant Flow|NeuroBlate Procedure|Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who underwent the NeuroBlate procedure
11111318|NCT01651078|OG000|Outcome|NeuroBlate Procedure|Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who already scheduled for NeuroBlate procedure.
11111319|NCT01651078|EG000|Reported Event|Main Cohort|Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who already scheduled for NeuroBlate procedure.
11111320|NCT01651104|BG000|Baseline|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
11111321|NCT01651104|FG000|Participant Flow|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
11111322|NCT01651104|OG000|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
11111323|NCT01651104|EG000|Reported Event|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
11111324|NCT01651117|BG000|Baseline|Stage 1 Usual Care|Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
11111325|NCT01651117|BG001|Baseline|Stage 1 Peer Mentoring|"Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.~For stage 2, they will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months."
11111326|NCT01651117|BG002|Baseline|Stage 2 Usual Care|Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
11111327|NCT01651117|BG003|Baseline|Stage 2 Peer Mentoring FFM (From Former Mentee)|Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
11111328|NCT01651117|BG004|Baseline|Total|Total of all reporting groups
11111329|NCT01651117|FG000|Participant Flow|Stage 1 Usual Care|Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
11126683|NCT01734811|OG000|Outcome|Placebo|"The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation~Biological vaccine: daily spray (2 puff of 100 µL) for six months"
10846009|NCT00272311|BG003|Baseline|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
10846010|NCT00272311|BG004|Baseline|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
11111330|NCT01651117|FG001|Participant Flow|Stage 1 Peer Mentoring|"Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.~For stage 2, they will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months."
11111331|NCT01651117|FG002|Participant Flow|Stage 2 Usual Care|Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
11111332|NCT01651117|FG003|Participant Flow|Stage 2 Peer Mentoring FFM (From Former Mentee)|Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
11111333|NCT01651117|OG000|Outcome|Stage 1 Usual Care|Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
11111334|NCT01651117|OG001|Outcome|Stage 1 Peer Mentoring|Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
11111335|NCT01651117|OG000|Outcome|Stage 2 Usual Care|Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
11111336|NCT01651117|OG001|Outcome|Stage 2 Peer Mentoring FFM (From Former Mentee)|Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
11111337|NCT01651117|OG000|Outcome|Stage 2 Non-mentor|Patients who received peer mentoring in stage 1 who were randomized to no further treatment.
11111338|NCT01651117|OG001|Outcome|Stage 2 Mentor|Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
11111339|NCT01651117|OG000|Outcome|Stage 1 Usual Care|Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
11111340|NCT01651117|EG000|Reported Event|Usual Care Stage 1|No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
10846011|NCT00272311|BG005|Baseline|Total|Total of all reporting groups
10846012|NCT00272311|FG000|Participant Flow|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
11111341|NCT01651117|EG001|Reported Event|Peer Mentoring|Participants in this arm will be mentored for 6 months by a veteran who was once in poor control but is now in good control. They will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.
11111342|NCT01651117|EG002|Reported Event|Peer Mentoring FFM (From Former Mentee)|Participants in this arm will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
11111343|NCT01651117|EG003|Reported Event|Usual Care Stage 2|No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
11111344|NCT01651195|BG000|Baseline|Probiotic Tablet (Military Recruits)|"Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks~Probiotic"
11111345|NCT01651195|BG001|Baseline|Placebo Tablet (Military Recruits)|"Chrystalline celluloce 2 x 2, 3 weeks~Placebo"
11111346|NCT01651195|BG002|Baseline|Probiotic Tablet (Reserve Officer Candidates)|"Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks~Probiotic"
11111347|NCT01651195|BG003|Baseline|Placebo Tablet (Reserve Officer Candidates)|"Chrystalline celluloce 2 x 2, 3 weeks~Placebo"
11111348|NCT01651195|BG004|Baseline|Total|Total of all reporting groups
11111349|NCT01651195|FG000|Participant Flow|Probiotic Tablet (Military Recruits)|"Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks~Probiotic"
11111350|NCT01651195|FG001|Participant Flow|Placebo Tablet (Military Recruits)|"Chrystalline celluloce 2 x 2, 3 weeks~Placebo"
11111351|NCT01651195|FG002|Participant Flow|Probiotic Tablet (Reserve Officer Candidates)|"Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks~Probiotic"
11111352|NCT01651195|FG003|Participant Flow|Placebo Tablet (Reserve Officer Candidates)|"Chrystalline celluloce 2 x 2, 3 weeks~Placebo"
11111353|NCT01651195|OG000|Outcome|Probiotic Tablet (Military Recruits)|Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks
11111354|NCT01651195|OG001|Outcome|Placebo Tablet (Military Recruits)|Crystalline cellulose 2 x 2, 3 weeks
11111355|NCT01651195|OG002|Outcome|Probiotic Tablet (Reserve Officer Candidates)|Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks
11111356|NCT01651195|OG003|Outcome|Placebo Tablet (Reserve Officer Candidates)|Crystalline cellulose 2 x 2, 3 weeks
11111357|NCT01651195|OG000|Outcome|Probiotic Tablet (Military Recruits)|"Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks~Probiotic"
11111358|NCT01651195|OG001|Outcome|Placebo Tablet (Military Recruits)|"Crystalline cellulose 2 x 2, 3 weeks~Placebo"
11111359|NCT01651195|OG002|Outcome|Probiotic Tablet (Reserve Officer Candidates)|"Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks~Probiotic"
11111360|NCT01651195|OG003|Outcome|Placebo Tablet (Reserve Officer Candidates)|"Crystalline cellulose 2 x 2, 3 weeks~Placebo"
11111361|NCT01651195|EG000|Reported Event|Probiotic Tablet (Military Recruits)|"Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks~Probiotic"
11111362|NCT01651195|EG001|Reported Event|Placebo Tablet (Military Recruits)|"Chrystalline celluloce 2 x 2, 3 weeks~Placebo"
11111363|NCT01651195|EG002|Reported Event|Probiotic Tablet (Reserve Officer Candidates)|"Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks~Probiotic"
11111364|NCT01651195|EG003|Reported Event|Placebo Tablet (Reserve Officer Candidates)|"Chrystalline celluloce 2 x 2, 3 weeks~Placebo"
11111365|NCT01651208|BG000|Baseline|Motivational Interviewing (MINT)|The MINT intervention will consist of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Contentedness, Self-Efficacy theory, and the Stages of Change model.
11111366|NCT01651208|BG001|Baseline|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
11111367|NCT01651208|BG002|Baseline|Total|Total of all reporting groups
11111368|NCT01651208|FG000|Participant Flow|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
11111369|NCT01651208|FG001|Participant Flow|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
11111370|NCT01651208|OG000|Outcome|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
11111371|NCT01651208|OG001|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
11111372|NCT01651208|OG000|Outcome|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.~Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
11111373|NCT01651208|EG000|Reported Event|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.~Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
11111374|NCT01651208|EG001|Reported Event|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
11111375|NCT01651260|BG000|Baseline|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
11111376|NCT01651260|FG000|Participant Flow|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
11111377|NCT01651260|OG000|Outcome|Hollister Endotracheal (ET) Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
11111378|NCT01651260|OG000|Outcome|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
11111379|NCT01651260|EG000|Reported Event|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
11111380|NCT01651351|BG000|Baseline|Cohort 1|Day 1: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Day 15: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Placebo: Human albumin 2.5%: Intravenous administration
11111381|NCT01651351|BG001|Baseline|Cohort 2|Day 1: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Day 15: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Placebo: Human albumin 2.5%: Intravenous administration
11111382|NCT01651351|BG002|Baseline|Total|Total of all reporting groups
11111383|NCT01651351|FG000|Participant Flow|Cohort 1|Day 1: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Day 15: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration. Placebo: Human albumin 2.5%: Intravenous administration
11111384|NCT01651351|FG001|Participant Flow|Cohort 2|Day 1: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Day 15: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration. Placebo: Human albumin 2.5%: Intravenous administration
11111385|NCT01651351|OG000|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
11111386|NCT01651351|OG001|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
11111387|NCT01651351|OG000|Outcome|All Study Participants|
11111388|NCT01651351|EG000|Reported Event|GLASSIA Infusion Rate- 0.04 mL/kg/Min|Participants who received simultaneous infusions of: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min
11111389|NCT01651351|EG001|Reported Event|GLASSIA Infusion Rate- 0.2 mL/kg/Min|Participants who received simultaneous infusions of: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min
11111390|NCT01651442|BG000|Baseline|Non-drug Sleep Therapy 1|Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
11111391|NCT01651442|BG001|Baseline|Sleep Medication 1|Zolpidem: 5mg or 10mg
11111392|NCT01651442|BG002|Baseline|Total|Total of all reporting groups
11111393|NCT01651442|FG000|Participant Flow|Non-drug Sleep Therapy 1|Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
11111394|NCT01651442|FG001|Participant Flow|Sleep Medication 1|Zolpidem: 5mg or 10mg
11111395|NCT01651442|FG002|Participant Flow|Non-drug Sleep Therapy 2 Following Non-drug Sleep Therapy 1|Cognitive Therapy: Cognitive restructuring, constructive worry, behavioral experiments presented in four sessions.
11111396|NCT01651442|FG003|Participant Flow|Sleep Medication 2 Following Sleep Medication 1|Trazodone: 50mg to 150mg
11111397|NCT01651442|FG004|Participant Flow|Non-drug Sleep Therapy 1 Following Sleep Medication 1|Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
11111398|NCT01651442|FG005|Participant Flow|Sleep Medication 1 Following Non-drug Sleep Therapy 1|Zolpidem: 5mg or 10mg
11111399|NCT01651442|OG000|Outcome|Non-drug Sleep Therapy 1|Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
11111400|NCT01651442|OG001|Outcome|Sleep Medication 1|Zolpidem: 5mg or 10mg
11111401|NCT01651442|OG002|Outcome|Sleep Medication 1 Plus Non-drug Sleep Therapy 1|Zolpidem Plus Behavioral Therapy
11111402|NCT01651442|OG003|Outcome|Sleep Medication 1 Plus Sleep Medication 2|Zolpidem Plus Trazodone
11111403|NCT01651442|OG004|Outcome|Non-drug Sleep Therapy 1 Plus Non-drug Sleep Therapy 1|Behavioral Therapy Plus Cognitive Therapy
11111404|NCT01651442|OG005|Outcome|Non-drug Sleep Therapy 1 Plus Sleep Medication 1|Behavioral Therapy Plus Zolpidem
11111405|NCT01651442|EG000|Reported Event|Non-drug Sleep Therapy 1|Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
11111406|NCT01651442|EG001|Reported Event|Sleep Medication 1|Zolpidem: 5mg or 10mg
11111407|NCT01651442|EG002|Reported Event|Non-drug Sleep Therapy 2|Cognitive Therapy: Cognitive restructuring, constructive worry, behavioral experiments presented in four sessions.
11111408|NCT01651442|EG003|Reported Event|Sleep Medication 2|Trazodone: 50mg to 150mg
11111409|NCT01651780|BG000|Baseline|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
11111410|NCT01651780|BG001|Baseline|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
11111411|NCT01651780|BG002|Baseline|Total|Total of all reporting groups
11111412|NCT01651780|FG000|Participant Flow|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during transcatheter aortic valve replacement (TAVR). It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
11111413|NCT01651780|FG001|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
11111414|NCT01651780|OG000|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
10846013|NCT00272311|FG001|Participant Flow|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
10846014|NCT00272311|FG002|Participant Flow|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
10846015|NCT00272311|FG003|Participant Flow|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
11111415|NCT01651780|OG001|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
11111416|NCT01651780|OG000|Outcome|Bivalirudin: First Half of Study Site's Enrolled Participants|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site's enrolled participants, and only sites with more than 20 participants are included in this analysis.
11126684|NCT01734811|OG001|Outcome|Biological Vaccine|"The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation~Biological vaccine: daily spray (2 puff of 100 µL) for six months"
11126685|NCT01734811|EG000|Reported Event|Placebo|"The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation~Biological vaccine: daily spray (2 puff of 100 µL) for six months"
11111417|NCT01651780|OG001|Outcome|Bivalirudin: Second Half of Study Site's Enrolled Participants|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site's enrolled participants, and only sites with more than 20 participants are included in this analysis.
11111418|NCT01651780|OG002|Outcome|UFH: First Half of Study Site's Enrolled Participants|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site's enrolled participants, and only sites with more than 20 participants are included in this analysis.
11111419|NCT01651780|OG003|Outcome|UFH: Second Half of Study Site's Enrolled Participants|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site's enrolled participants, and only sites with more than 20 participants are included in this analysis.
11111420|NCT01651780|EG000|Reported Event|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
11111421|NCT01651780|EG001|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
11111422|NCT01651793|BG000|Baseline|All Completed Participants|These baseline data represent all participants who completed the trial (n = 23). Data are presented as means and standard deviations where appropriate.
11111423|NCT01651793|FG000|Participant Flow|Caffeinated Cocoa, Cocoa, Caffeine, Placebo|Order: Caffeinated cocoa, cocoa, caffeine, Placebo; 6 participants were randomized to this order.
11111424|NCT01651793|FG001|Participant Flow|Cocoa, Caffeine, Placebo, Caffeinated Cocoa|Order: Cocoa, Caffeine, Placebo, Caffeinated Cocoa; 6 participants were randomize to receive treatment in this order.
11111425|NCT01651793|FG002|Participant Flow|Caffeine, Placebo, Caffeinated Cocoa, Cocoa|Order: Caffeine, Placebo, Caffeinated cocoa, Cocoa; 6 participants were randomized to receive treatment in this order.
11111426|NCT01651793|FG003|Participant Flow|Placebo, Caffeinated Cocoa, Cocoa, Caffeine|Order: Placebo, Caffeinated cocoa, Cocoa, Caffeine; 6 participants were randomized to receive treatment in this order.
11111427|NCT01651793|OG000|Outcome|Pre-test|Baseline measures, pre consumption of beverages.
11111428|NCT01651793|OG001|Outcome|Post-test 1|21-47 minutes post consumption.
11111429|NCT01651793|OG002|Outcome|Post-test 2|57-83 minutes post consumption.
11111430|NCT01651793|OG003|Outcome|Post-test 3|93-119 minutes post consumption.
11111431|NCT01651793|OG000|Outcome|Pre-test|Mood measure at baseline.
10846016|NCT00272311|FG004|Participant Flow|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
11111432|NCT01651793|OG001|Outcome|Post-test 1|22-48 minutes post consumption.
11111433|NCT01651793|OG002|Outcome|Post-test 2|60-86 minutes post consumption.
11111434|NCT01651793|OG003|Outcome|Post-test 3|98-124 minutes post consumption.
11111435|NCT01651793|EG000|Reported Event|Caffeinated Cocoa|"High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle~Active comparator 1: High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle"
10846017|NCT00272311|OG000|Outcome|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
10846018|NCT00272311|OG001|Outcome|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
10846019|NCT00272311|OG002|Outcome|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
11111436|NCT01651793|EG001|Reported Event|Cocoa|"High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle~Active comparator 2: High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle"
11111437|NCT01651793|EG002|Reported Event|Cafeine|"Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle~Active comparator 4: Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle"
11111438|NCT01651793|EG003|Reported Event|Placebo|"No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle~Inactive comparator: No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle"
11111439|NCT01651806|BG000|Baseline|Female Patients Receiving a Uniform Dose of TA|"Female Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.~Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA."
11111440|NCT01651806|BG001|Baseline|Female Weighted Dose of TA Patients|"Female Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.~Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given"
11111441|NCT01651806|BG002|Baseline|Control|Historical cohort of primary TKAs performed by senior author, none of which received TA.
11111442|NCT01651806|BG003|Baseline|Male Patients Receiving a Uniform Dose of TA|"Male Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.~Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA."
11126686|NCT01734811|EG001|Reported Event|Biological Vaccine|"The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation~Biological vaccine: daily spray (2 puff of 100 µL) for six months"
11111443|NCT01651806|BG004|Baseline|Male Weighted Dose of TA Patients|"Male Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.~Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given"
11111444|NCT01651806|BG005|Baseline|Total|Total of all reporting groups
11111445|NCT01651806|FG000|Participant Flow|Female Uniform Single Dose TA Patient|"Female patients receiving a single dose (1gram) of TA during TKA. Includes all female patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
11111446|NCT01651806|FG001|Participant Flow|Female Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
11111447|NCT01651806|FG002|Participant Flow|Control|"Historical cohort of primary TKAs performed by BL, none of which received TA.~A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651."
11111448|NCT01651806|FG003|Participant Flow|Male Uniform Single Dose TA Patient|"Male patients receiving a single dose (1gram) of TA during TKA. Includes all male patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
11111449|NCT01651806|FG004|Participant Flow|Male Weighted Dose TA Patient|"Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
11111450|NCT01651806|OG000|Outcome|Female Uniform Single Dose TA Patient|"Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
11111451|NCT01651806|OG001|Outcome|Female Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
11111452|NCT01651806|OG002|Outcome|Control|Historical cohort of primary TKAs performed by BL, none of which received TA.
11111453|NCT01651806|OG003|Outcome|Male Uniform Single Dose TA|"Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
11111454|NCT01651806|OG004|Outcome|Male Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
11111455|NCT01651806|OG004|Outcome|Male Weighted Dose TA|"Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
11111456|NCT01651806|EG000|Reported Event|Female Uniform Single Dose TA Patient|"Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
11111457|NCT01651806|EG001|Reported Event|Female Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
11111458|NCT01651806|EG002|Reported Event|Control|Historical cohort of primary TKAs performed by BL, none of which received TA.
11111459|NCT01651806|EG003|Reported Event|Male Uniform Single Dose TA Patient|"Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
11111460|NCT01651806|EG004|Reported Event|Male Weighted Dose TA|"Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
11111461|NCT01651936|BG000|Baseline|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
11111462|NCT01651936|BG001|Baseline|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
11111463|NCT01651936|BG002|Baseline|Total|Total of all reporting groups
11111464|NCT01651936|FG000|Participant Flow|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
10846020|NCT00272311|OG003|Outcome|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
10846021|NCT00272311|OG004|Outcome|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
11111465|NCT01651936|FG001|Participant Flow|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
11111466|NCT01651936|FG002|Participant Flow|Extension Study: MK-8457|MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study.
11111467|NCT01651936|OG000|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
11111468|NCT01651936|OG001|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
11111469|NCT01651936|EG000|Reported Event|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
11111470|NCT01651936|EG001|Reported Event|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
11111471|NCT01651936|EG002|Reported Event|Extension Study: MK-8457|MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study
11111472|NCT01651949|BG000|Baseline|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111473|NCT01651949|BG001|Baseline|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111474|NCT01651949|BG002|Baseline|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111475|NCT01651949|BG003|Baseline|Total|Total of all reporting groups
11111476|NCT01651949|FG000|Participant Flow|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111477|NCT01651949|FG001|Participant Flow|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111478|NCT01651949|FG002|Participant Flow|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111479|NCT01651949|OG000|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111480|NCT01651949|OG001|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111481|NCT01651949|OG002|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111482|NCT01651949|OG000|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111483|NCT01651949|EG000|Reported Event|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111484|NCT01651949|EG001|Reported Event|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11111485|NCT01652001|BG000|Baseline|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
10846022|NCT00272311|EG000|Reported Event|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
11111486|NCT01652001|BG001|Baseline|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
11111487|NCT01652001|BG002|Baseline|Total|Total of all reporting groups
11111488|NCT01652001|FG000|Participant Flow|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
11111489|NCT01652001|FG001|Participant Flow|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
11111490|NCT01652001|OG000|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
11111491|NCT01652001|OG001|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
11111492|NCT01652001|EG000|Reported Event|Malic Acid 1%|Patients treated with Malic Acid 1%
11111493|NCT01652001|EG001|Reported Event|Control|Patients treated with a placebo
11111494|NCT01652040|BG000|Baseline|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
11111495|NCT01652040|BG001|Baseline|Testosterone Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
11111496|NCT01652040|BG002|Baseline|Total|Total of all reporting groups
11111497|NCT01652040|FG000|Participant Flow|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
11111498|NCT01652040|FG001|Participant Flow|Testosterone Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
11111499|NCT01652040|OG000|Outcome|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
11111500|NCT01652040|OG001|Outcome|Testosteroe Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
11111501|NCT01652040|OG001|Outcome|Testosterone Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
11111502|NCT01652040|EG000|Reported Event|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
11111503|NCT01652040|EG001|Reported Event|Testosterone Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
11111504|NCT01652287|BG000|Baseline|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
11111505|NCT01652287|BG001|Baseline|Control|yogurt cultured with starter YF-L702
11111506|NCT01652287|BG002|Baseline|Total|Total of all reporting groups
11111507|NCT01652287|FG000|Participant Flow|BB-12|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
11111508|NCT01652287|FG001|Participant Flow|Control|yogurt cultured with starter YF-L702
11111509|NCT01652287|OG000|Outcome|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
11111510|NCT01652287|OG001|Outcome|Control|yogurt cultured with starter YF-L702
11111511|NCT01652287|EG000|Reported Event|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
11111512|NCT01652287|EG001|Reported Event|Control|yogurt cultured with starter YF-L702
11111513|NCT01652469|BG000|Baseline|A: Erlotinib|"Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.~Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle."
11111514|NCT01652469|BG001|Baseline|B: Docetaxel|"Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.~Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days."
11111515|NCT01652469|BG002|Baseline|Total|Total of all reporting groups
11111516|NCT01652469|FG000|Participant Flow|A: Erlotinib|"Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.~Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle."
11111517|NCT01652469|FG001|Participant Flow|B: Docetaxel|"Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.~Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days."
11111518|NCT01652469|OG000|Outcome|A: Erlotinib|"Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.~Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle."
11111519|NCT01652469|OG001|Outcome|B: Docetaxel|"Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.~Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days."
11111520|NCT01652469|EG000|Reported Event|A: Erlotinib|"Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.~Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle."
11111521|NCT01652469|EG001|Reported Event|B: Docetaxel|"Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.~Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days."
11111522|NCT01652495|BG000|Baseline|Methylprednisolone Acetate|Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate
11111523|NCT01652495|BG001|Baseline|Triamcinolone Acetonide|Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide
11111524|NCT01652495|BG002|Baseline|Total|Total of all reporting groups
11111525|NCT01652495|FG000|Participant Flow|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
11111526|NCT01652495|FG001|Participant Flow|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
11111527|NCT01652495|OG000|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
11111528|NCT01652495|OG001|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
11111529|NCT01652495|OG000|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate"
11111530|NCT01652495|OG001|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide"
11111531|NCT01652495|EG000|Reported Event|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
11111532|NCT01652495|EG001|Reported Event|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
11111533|NCT01652573|BG000|Baseline|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
11111534|NCT01652573|BG001|Baseline|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
11111535|NCT01652573|BG002|Baseline|Total|Total of all reporting groups
11111536|NCT01652573|FG000|Participant Flow|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
10846023|NCT00272311|EG001|Reported Event|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
11111537|NCT01652573|FG001|Participant Flow|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
11111538|NCT01652573|OG000|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
11111539|NCT01652573|OG001|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
11111540|NCT01652573|EG000|Reported Event|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
11111541|NCT01652573|EG001|Reported Event|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
11111542|NCT01652664|BG000|Baseline|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
11111543|NCT01652664|BG001|Baseline|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
11111544|NCT01652664|BG002|Baseline|Total|Total of all reporting groups
11111545|NCT01652664|FG000|Participant Flow|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
11111546|NCT01652664|FG001|Participant Flow|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
11111547|NCT01652664|OG000|Outcome|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
11111548|NCT01652664|OG001|Outcome|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
11111549|NCT01652664|EG000|Reported Event|Pre-Treatment|All enrolled participants
11111550|NCT01652664|EG001|Reported Event|Travoprost|All participants who received travoprost with vehicle
11111551|NCT01652664|EG002|Reported Event|Timolol|All participants who received timolol; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
11111552|NCT01652690|BG000|Baseline|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
11111553|NCT01652690|BG001|Baseline|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
11111554|NCT01652690|BG002|Baseline|Total|Total of all reporting groups
11111555|NCT01652690|FG000|Participant Flow|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
11111556|NCT01652690|FG001|Participant Flow|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
11111557|NCT01652690|OG000|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
11111558|NCT01652690|OG001|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
11111559|NCT01652690|EG000|Reported Event|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
11111560|NCT01652690|EG001|Reported Event|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
11111561|NCT01652703|BG000|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11111562|NCT01652703|BG001|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11111563|NCT01652703|BG002|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11111564|NCT01652703|BG003|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11111565|NCT01652703|BG004|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11111566|NCT01652703|BG005|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11111567|NCT01652703|BG006|Baseline|Total|Total of all reporting groups
11111568|NCT01652703|FG000|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11111569|NCT01652703|FG001|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11111570|NCT01652703|FG002|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11111571|NCT01652703|FG003|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11111572|NCT01652703|FG004|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11111573|NCT01652703|FG005|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11111574|NCT01652703|OG000|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11111575|NCT01652703|OG001|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11111576|NCT01652703|OG002|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
10846024|NCT00272311|EG002|Reported Event|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
11111577|NCT01652703|OG003|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11111578|NCT01652703|OG004|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11111579|NCT01652703|OG005|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11111580|NCT01652703|EG000|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11111581|NCT01652703|EG001|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11111582|NCT01652703|EG002|Reported Event|Evolocumab Q2W 70 MG|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11111583|NCT01652703|EG003|Reported Event|Evolocumab Q2W 140 MG|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11111584|NCT01652703|EG004|Reported Event|Evolocumab Q4W 280 MG|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11111585|NCT01652703|EG005|Reported Event|Evolocumab Q4W 420 MG|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11111586|NCT01652716|BG000|Baseline|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
11111587|NCT01652716|BG001|Baseline|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
11111588|NCT01652716|BG002|Baseline|Total|Total of all reporting groups
11111589|NCT01652716|FG000|Participant Flow|Experimental: Exenatide Once Weekly (QWS) Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
11111590|NCT01652716|FG001|Participant Flow|Active Comparator: Exenatide Twice Daily (BID)|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
11111591|NCT01652716|OG000|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
11111592|NCT01652716|OG001|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
11111593|NCT01652716|EG000|Reported Event|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)
11111594|NCT01652716|EG001|Reported Event|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
11111595|NCT01652729|BG000|Baseline|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
11111596|NCT01652729|BG001|Baseline|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
11111597|NCT01652729|BG002|Baseline|Placebo Comparator: Placebo|Placebo oral tablet once daily
11111598|NCT01652729|BG003|Baseline|Total|Total of all reporting groups
11111599|NCT01652729|FG000|Participant Flow|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
11111600|NCT01652729|FG001|Participant Flow|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
11111601|NCT01652729|FG002|Participant Flow|Placebo Comparator: Placebo|Placebo oral tablet once daily
11111602|NCT01652729|OG000|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
11111603|NCT01652729|OG001|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
11111604|NCT01652729|OG002|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
10846025|NCT00272311|EG003|Reported Event|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
10846026|NCT00272311|EG004|Reported Event|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
11111605|NCT01652729|EG000|Reported Event|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
11111606|NCT01652729|EG001|Reported Event|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
11111607|NCT01652729|EG002|Reported Event|Placebo Comparator: Placebo|Placebo oral tablet once daily
11111608|NCT01652872|BG000|Baseline|Hb-Based Titration Group|Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
11111609|NCT01652872|BG001|Baseline|Fixed Dose Group|Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
11111610|NCT01652872|BG002|Baseline|Total|Total of all reporting groups
11111611|NCT01652872|FG000|Participant Flow|Hb-Based Titration Group|Participants received darbepoetin alfa as a subcutaneous (SC) injection once every 4 weeks (Q4W) for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb rate of rise (ROR), and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 grams/deciliter (g/dL) or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 micrograms/kilogram (mcg/kg) and the protocol specified doses ranged from 10 to 300 mcg.
11126687|NCT01734850|BG000|Baseline|Cohort 1 (CSL202 With No Busulfan)|Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
10846027|NCT00272337|BG000|Baseline|1 of 5 Randomized Treatment Arms|81 mg Aspirin
10846028|NCT00272337|BG001|Baseline|2 of 5 Randomized Treatment Arms|162 mg Aspirin
11111612|NCT01652872|FG001|Participant Flow|Fixed Dose Group|Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
11111613|NCT01652872|OG000|Outcome|Hb-Based Titration Group|Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
11111614|NCT01652872|OG001|Outcome|Fixed Dose Group|Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
11111615|NCT01652872|EG000|Reported Event|Hb-Based Titration Group|Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
11111616|NCT01652872|EG001|Reported Event|Fixed Dose Group|Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
11111617|NCT01652885|BG000|Baseline|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
11111618|NCT01652885|FG000|Participant Flow|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate atopic dermatitis (AD), twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
11111619|NCT01652885|OG000|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
11111620|NCT01652885|EG000|Reported Event|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
11111621|NCT01652976|BG000|Baseline|Treatment Arm|"Dasatinib and mFOLFOX6~Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle~mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle"
11111622|NCT01652976|FG000|Participant Flow|Dasatinib and mFOLFOX6|"Dasatinib and mFOLFOX6~Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle~mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle"
11111623|NCT01652976|OG000|Outcome|Dasatinib and mFOLFOX6|"Dasatinib and mFOLFOX6~Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle~mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle"
11111624|NCT01652976|EG000|Reported Event|Treatment Arm|"Dasatinib and mFOLFOX6~Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle~mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle"
11111625|NCT01653028|BG000|Baseline|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111626|NCT01653028|BG001|Baseline|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111627|NCT01653028|BG002|Baseline|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111628|NCT01653028|BG003|Baseline|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111629|NCT01653028|BG004|Baseline|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111630|NCT01653028|BG005|Baseline|Total|Total of all reporting groups
10846029|NCT00272337|BG002|Baseline|3 of 5 Randomized Treatment Arms|325 mg Aspirin
11111631|NCT01653028|FG000|Participant Flow|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111632|NCT01653028|FG001|Participant Flow|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10846030|NCT00272337|BG003|Baseline|4 of 5 Randomized Treatment Arms|650 mg Aspirin
10846031|NCT00272337|BG004|Baseline|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
11111633|NCT01653028|FG002|Participant Flow|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111634|NCT01653028|FG003|Participant Flow|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111635|NCT01653028|FG004|Participant Flow|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111636|NCT01653028|OG000|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111637|NCT01653028|OG001|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111638|NCT01653028|OG002|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111639|NCT01653028|OG003|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111640|NCT01653028|OG004|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111641|NCT01653028|EG000|Reported Event|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111642|NCT01653028|EG001|Reported Event|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111643|NCT01653028|EG002|Reported Event|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111644|NCT01653028|EG003|Reported Event|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111645|NCT01653028|EG004|Reported Event|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11111646|NCT01653132|BG000|Baseline|All Study Participants|Participants who received either Placebo, 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each) and submandibular ( 0.3 ml each), or Incobotulinum Toxin A 100 units, 20 units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
11111647|NCT01653132|FG000|Participant Flow|Placebo First, Then Incobotulinum Toxin A|sterile, preservative free 0.9% saline, 1 ml of saline into the parotid and submandibular glands in first intervention period
11111648|NCT01653132|FG001|Participant Flow|Incobotulinum Toxin A First, Then Placebo|Incobotulinum toxin, 100 units, diluted in 1 ml 0.9% sterile saline. 20 units (0.2 ml) were injected into each parotid gland and 30 units (0.3 ml) into each submandibular gland using anatomical landmarks
11111649|NCT01653132|OG000|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
11111650|NCT01653132|OG001|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
11111651|NCT01653132|OG000|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
11111652|NCT01653132|OG001|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
11111653|NCT01653132|OG000|Outcome|Incobotulinum Toxin A|"Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks~Incobotulinum Toxin A: Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks"
11111654|NCT01653132|OG001|Outcome|Placebo|"Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .~Placebo: Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands ."
11111655|NCT01653132|EG000|Reported Event|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each) and submandibular (30 units, 0.3ml each) glands of subjects
11111656|NCT01653132|EG001|Reported Event|Placebo|Sterile, preservative free 0.9% saline, 1 mL injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
11111657|NCT01653158|BG000|Baseline|Entire Study Population|Includes all enrolled participants who received single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously at each cycle (1 cycle = 21 days).
11111658|NCT01653158|FG000|Participant Flow|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111659|NCT01653158|FG001|Participant Flow|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111660|NCT01653158|FG002|Participant Flow|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
10846032|NCT00272337|BG005|Baseline|Total|Total of all reporting groups
11111661|NCT01653158|FG003|Participant Flow|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111662|NCT01653158|FG004|Participant Flow|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111663|NCT01653158|FG005|Participant Flow|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111664|NCT01653158|FG006|Participant Flow|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111665|NCT01653158|FG007|Participant Flow|CP-751,871 20 mg/kg + Docetaxel|"In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days).~In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1."
11111666|NCT01653158|OG000|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111667|NCT01653158|OG000|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
11111668|NCT01653158|OG000|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
11111669|NCT01653158|OG000|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111670|NCT01653158|OG001|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111671|NCT01653158|OG002|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111672|NCT01653158|OG003|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111673|NCT01653158|OG004|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111674|NCT01653158|OG005|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111675|NCT01653158|OG006|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111676|NCT01653158|OG007|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
11111677|NCT01653158|OG007|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111678|NCT01653158|OG003|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111679|NCT01653158|EG000|Reported Event|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111680|NCT01653158|EG001|Reported Event|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111681|NCT01653158|EG002|Reported Event|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111682|NCT01653158|EG003|Reported Event|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
10846033|NCT00272337|FG000|Participant Flow|1 of 5 Randomized Treatment Arms|81 mg Aspirin
11111683|NCT01653158|EG004|Reported Event|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111684|NCT01653158|EG005|Reported Event|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111685|NCT01653158|EG006|Reported Event|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
11111686|NCT01653158|EG007|Reported Event|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
11111687|NCT01653210|BG000|Baseline|Female T1DM|Premenopausal women with menstrual cycles, 18-55 years of age, who have been diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is prohibited.
11111688|NCT01653210|FG000|Participant Flow|Female T1DM|Premenopausal women with menstrual cycles, 18-55 years of age, who have been diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is prohibited.
11111689|NCT01653210|OG000|Outcome|Female T1DM|Premenopausal women with menstrual cycles, 18-55 years of age, who have been diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is prohibited.
11111690|NCT01653210|EG000|Reported Event|Female T1DM|Twelve premenopausal women with menstrual cycles, 18-55 years of age, who have been diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is prohibited.
11111691|NCT01653262|BG000|Baseline|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
11111692|NCT01653262|FG000|Participant Flow|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
11111693|NCT01653262|OG000|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
11111694|NCT01653262|EG000|Reported Event|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
11111695|NCT01653288|BG000|Baseline|Coping Coach|"Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.~Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help."
11111696|NCT01653288|BG001|Baseline|Coping Coach Waitlist Control|"Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.~Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help."
11111697|NCT01653288|BG002|Baseline|Total|Total of all reporting groups
10846034|NCT00272337|FG001|Participant Flow|2 of 5 Randomized Treatment Arms|162 mg Aspirin
11111698|NCT01653288|FG000|Participant Flow|Coping Coach|"Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.~Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help."
11111699|NCT01653288|FG001|Participant Flow|Coping Coach Waitlist Control|"Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.~Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help."
11111700|NCT01653288|OG000|Outcome|Coping Coach|"Usage data reported for baseline to week 6~Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks."
11111701|NCT01653288|OG001|Outcome|Coping Coach Waitlist Control|"Usage data reported for weeks 12 to 18 (i.e when this arm had access to the online intervention)~Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks."
11111702|NCT01653288|OG000|Outcome|Coping Coach|"Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.~Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help."
11111703|NCT01653288|OG001|Outcome|Coping Coach Waitlist Control|"Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.~Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help."
11111704|NCT01653288|EG000|Reported Event|Coping Coach|"Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.~Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help."
11111705|NCT01653288|EG001|Reported Event|Coping Coach Waitlist Control|"Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.~Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help."
11111706|NCT01653327|BG000|Baseline|Cohort|All individuals participating in the trial.
11111707|NCT01653327|FG000|Participant Flow|All Study Participants|"Ketamine: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.~The placebo consisted of 4 ml of cherry syrup and 1 ml of normal saline."
11111708|NCT01653327|OG000|Outcome|Ketamine|Ketamine: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
11111709|NCT01653327|OG001|Outcome|Placebo|The placebo consisted of 4 ml of cherry syrup and 1 ml of normal saline.
11111710|NCT01653327|EG000|Reported Event|Ketamine|Ketamine: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
11111711|NCT01653327|EG001|Reported Event|Placebo|The placebo will consist of 4 ml of cherry syrup and 1 ml of normal saline.
11111712|NCT01653405|BG000|Baseline|Intervention Group|VA patients receiving anticoagulation clinic services at 8 sites in VISN 1.
11111713|NCT01653405|BG001|Baseline|Control Group|VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.
11111714|NCT01653405|BG002|Baseline|Total|Total of all reporting groups
11111715|NCT01653405|FG000|Participant Flow|VISN1 (Intervention Group)|VA patients receiving care at anticoagulation clinics at 8 sites within VISN 1
11111716|NCT01653405|FG001|Participant Flow|Outside VISN1 (Control Group)|VA patients receiving care at anticoagulation clinics at 116 sites outside of VISN 1.
11111717|NCT01653405|OG000|Outcome|Intervention Group|VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.
11111718|NCT01653405|OG001|Outcome|Control Group|VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.
11111719|NCT01653405|EG000|Reported Event|VISN1 (Intervention Group)|
11111720|NCT01653405|EG001|Reported Event|Outside VISN1 (Control Group)|
11111721|NCT01653418|BG000|Baseline|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
11111722|NCT01653418|FG000|Participant Flow|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
11111723|NCT01653418|OG000|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
11111724|NCT01653418|EG000|Reported Event|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
11111725|NCT01653509|BG000|Baseline|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
11111726|NCT01653509|BG001|Baseline|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
11111727|NCT01653509|BG002|Baseline|Total|Total of all reporting groups
11111728|NCT01653509|FG000|Participant Flow|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
11111729|NCT01653509|FG001|Participant Flow|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
11111730|NCT01653509|OG000|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
11111731|NCT01653509|OG001|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
11111732|NCT01653509|OG000|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
11111733|NCT01653509|OG001|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
11111734|NCT01653509|EG000|Reported Event|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area.
11111735|NCT01653509|EG001|Reported Event|Placebo Patch|Participants applied single placebo patch to the cold sore area.
11111736|NCT01653587|BG000|Baseline|Transradial Approach|"Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis~Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines."
11111737|NCT01653587|BG001|Baseline|Transfemoral Approach|"Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis~Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines."
11111738|NCT01653587|BG002|Baseline|Total|Total of all reporting groups
11111739|NCT01653587|FG000|Participant Flow|Transradial Approach|"Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis~Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines."
11111740|NCT01653587|FG001|Participant Flow|Transfemoral Approach|"Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis~Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines."
11111741|NCT01653587|OG000|Outcome|Transradial Approach|"Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis~Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines."
11111742|NCT01653587|OG001|Outcome|Transfemoral Approach|"Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis~Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines."
11111743|NCT01653587|EG000|Reported Event|Transradial Approach|"Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis~Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines."
11111744|NCT01653587|EG001|Reported Event|Transfemoral Approach|"Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis~Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines."
11111745|NCT01653704|BG000|Baseline|Active Management of Crises Scenario|"participants assigned to actively manage a crisis scenario~active role: active role in managing crisis scenario"
11111746|NCT01653704|BG001|Baseline|Observer Role in Crisis Scenario|"Observational role in management of crises scenario~observational role: observational role in crisis scenario"
11111747|NCT01653704|BG002|Baseline|Total|Total of all reporting groups
11111748|NCT01653704|FG000|Participant Flow|Active Management of Crises Scenario|"participants assigned to actively manage a crisis scenario~active role: active role in managing crisis scenario"
11111749|NCT01653704|FG001|Participant Flow|Observer Role in Crisis Scenario|"Observational role in management of crises scenario~observational role: observational role in crisis scenario"
11111750|NCT01653704|OG000|Outcome|Active Management of Crises Scenario|"participants assigned to actively manage a crisis scenario~active role: active role in managing crisis scenario"
11111751|NCT01653704|OG001|Outcome|Observer Role in Crisis Scenario|"Observational role in management of crises scenario~observational role: observational role in crisis scenario"
11111752|NCT01653704|EG000|Reported Event|Active Management of Crises Scenario|"participants assigned to actively manage a crisis scenario~active role: active role in managing crisis scenario"
10846035|NCT00272337|FG002|Participant Flow|3 of 5 Randomized Treatment Arms|325 mg Aspirin
10846036|NCT00272337|FG003|Participant Flow|4 of 5 Randomized Treatment Arms|650 mg Aspirin
11111753|NCT01653704|EG001|Reported Event|Observer Role in Crisis Scenario|"Observational role in management of crises scenario~observational role: observational role in crisis scenario"
11111754|NCT01653743|BG000|Baseline|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
11111755|NCT01653743|BG001|Baseline|Urinary Human Chorionic Gonadotropin (u-hCG)|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
11111756|NCT01653743|BG002|Baseline|Total|Total of all reporting groups
11111757|NCT01653743|FG000|Participant Flow|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
11111758|NCT01653743|FG001|Participant Flow|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
11111759|NCT01653743|OG000|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
11111760|NCT01653743|OG001|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
11111761|NCT01653743|EG000|Reported Event|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
11111762|NCT01653743|EG001|Reported Event|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
11111763|NCT01653782|BG000|Baseline|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
11111764|NCT01653782|BG001|Baseline|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
11111765|NCT01653782|BG002|Baseline|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 2 hours, twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
11111766|NCT01653782|BG003|Baseline|Total|Total of all reporting groups
10878617|NCT00453362|OG000|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight no to exceed 15 mCi."
11111767|NCT01653782|FG000|Participant Flow|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
11111768|NCT01653782|FG001|Participant Flow|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
11111769|NCT01653782|FG002|Participant Flow|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes of intructor-led yoga each week) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
11111770|NCT01653782|OG000|Outcome|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
11111771|NCT01653782|OG001|Outcome|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
11111772|NCT01653782|OG002|Outcome|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes each week of instructor-led yoga) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
11111773|NCT01653782|EG000|Reported Event|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
11111774|NCT01653782|EG001|Reported Event|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
11111775|NCT01653782|EG002|Reported Event|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
11111776|NCT01653847|BG000|Baseline|Group 1: Tacrolimus With MMF.|"This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.~Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL."
11111777|NCT01653847|BG001|Baseline|Group 2: Tacrolimus With Everolimus|"This group will receive a low dose Tacrolimus with concentration controlled Everolimus~Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is < 3 ng/mL, or reduced if the trough level is > 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC)."
11111778|NCT01653847|BG002|Baseline|Total|Total of all reporting groups
11111779|NCT01653847|FG000|Participant Flow|Group 1: Tacrolimus With MMF.|"This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.~Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL."
11111780|NCT01653847|FG001|Participant Flow|Group 2: Tacrolimus With Everolimus|"This group will receive a low dose Tacrolimus with concentration controlled Everolimus~Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is < 3 ng/mL, or reduced if the trough level is > 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC)."
11111781|NCT01653847|OG000|Outcome|Group 1: Tacrolimus With MMF.|"This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.~Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL."
11126688|NCT01734850|BG001|Baseline|Cohort 2 (CSL202 With 1 Busulfan Dose)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11126689|NCT01734850|BG002|Baseline|Cohort 3 (CSL202 With 2 Busulfan Doses)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11126690|NCT01734850|BG003|Baseline|Total|Total of all reporting groups
11111782|NCT01653847|OG001|Outcome|Group 2: Tacrolimus With Everolimus|"This group will receive a low dose Tacrolimus with concentration controlled Everolimus~Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is < 3 ng/mL, or reduced if the trough level is > 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC)."
11111783|NCT01653847|EG000|Reported Event|Group 1: Tacrolimus With MMF.|"This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.~Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL."
11111784|NCT01653847|EG001|Reported Event|Group 2: Tacrolimus With Everolimus|"This group will receive a low dose Tacrolimus with concentration controlled Everolimus~Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is < 3 ng/mL, or reduced if the trough level is > 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC)."
11111785|NCT01653912|BG000|Baseline|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
11111786|NCT01653912|BG001|Baseline|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
11111787|NCT01653912|BG002|Baseline|Total|Total of all reporting groups
11111788|NCT01653912|FG000|Participant Flow|Phase 1 (Dose Escalation)-Cohort 1: GSK2110183 50 mg|GSK2110183 50 mg capsule by mouth daily in combination with carboplatin Area Under the Curve (AUC) 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
11111789|NCT01653912|FG001|Participant Flow|Phase 1 (Dose Escalation)-Cohort 1.5: GSK2110183 75 mg|GSK2110183 75 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
11111790|NCT01653912|FG002|Participant Flow|Phase 1 (Dose Escalation)-Cohort 2: GSK2110183 100 mg|GSK2110183 100 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
11111791|NCT01653912|FG003|Participant Flow|Phase 1 (Dose Escalation)-Cohort 3: GSK2110183 125 mg|GSK2110183 125 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
11111792|NCT01653912|FG004|Participant Flow|Phase 1 (Dose Escalation)-Cohort 4: GSK2110183 150 mg|GSK2110183 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
11111793|NCT01653912|FG005|Participant Flow|Phase 2 (Treatment Group): GSK2110183 125 mg (MTD)|The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
11111794|NCT01653912|OG000|Outcome|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
11111795|NCT01653912|OG000|Outcome|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
11111796|NCT01653912|EG000|Reported Event|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
11111797|NCT01653912|EG001|Reported Event|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
11111798|NCT01653964|BG000|Baseline|Molecular Breast Imaging|"Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.~Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)"
11111799|NCT01653964|FG000|Participant Flow|Molecular Breast Imaging|Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 millicurie (mCi) Tc-99m sestamibi.
11111800|NCT01653964|OG000|Outcome|Molecular Breast Imaging|Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.
11111801|NCT01653964|EG000|Reported Event|Molecular Breast Imaging|"Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.~Molecular breast imaging: Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)"
11111802|NCT01654068|BG000|Baseline|Radiation Therapy to Local Spine Metastasis|"Conformal High Dose Intensity Modulated Radiation Therapy~Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons"
11111803|NCT01654068|FG000|Participant Flow|Radiation Therapy to Local Spine Metastasis|"Conformal High Dose Intensity Modulated Radiation Therapy~Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons"
11111804|NCT01654068|OG000|Outcome|Radiation Therapy to Local Spine Metastasis|"Conformal High Dose Intensity Modulated Radiation Therapy~Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons"
11111805|NCT01654068|EG000|Reported Event|Radiation Therapy to Local Spine Metastasis|"Conformal High Dose Intensity Modulated Radiation Therapy~Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons"
11111806|NCT01654107|BG000|Baseline|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
11111807|NCT01654107|BG001|Baseline|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
11111808|NCT01654107|BG002|Baseline|Total|Total of all reporting groups
11111809|NCT01654107|FG000|Participant Flow|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
11111810|NCT01654107|FG001|Participant Flow|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
11111811|NCT01654107|OG000|Outcome|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
11111812|NCT01654107|OG001|Outcome|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
11111813|NCT01654107|EG000|Reported Event|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
11111814|NCT01654107|EG001|Reported Event|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
11111815|NCT01654224|BG000|Baseline|HD IIV|Frail adults 65 years and older who received Fluzone High Dose intramuscularly
11111816|NCT01654224|BG001|Baseline|SD IIV|Frail adults 65 years and older who received Fluzone Standard Dose intramuscularly
11111817|NCT01654224|BG002|Baseline|Total|Total of all reporting groups
11111818|NCT01654224|FG000|Participant Flow|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
11111819|NCT01654224|FG001|Participant Flow|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
11111820|NCT01654224|OG000|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
11111821|NCT01654224|OG001|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
11111822|NCT01654224|EG000|Reported Event|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
11111823|NCT01654224|EG001|Reported Event|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
11111824|NCT01654250|BG000|Baseline|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111825|NCT01654250|BG001|Baseline|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111826|NCT01654250|BG002|Baseline|Total|Total of all reporting groups
11111827|NCT01654250|FG000|Participant Flow|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111828|NCT01654250|FG001|Participant Flow|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111829|NCT01654250|OG000|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111830|NCT01654250|OG001|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111831|NCT01654250|OG000|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111832|NCT01654250|EG000|Reported Event|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111833|NCT01654250|EG001|Reported Event|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
11111834|NCT01654263|BG000|Baseline|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
11111835|NCT01654263|BG001|Baseline|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
11111836|NCT01654263|BG002|Baseline|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111837|NCT01654263|BG003|Baseline|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111838|NCT01654263|BG004|Baseline|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111839|NCT01654263|BG005|Baseline|IIBB: Age 65-74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111840|NCT01654263|BG006|Baseline|Total|Total of all reporting groups
11111841|NCT01654263|FG000|Participant Flow|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
11111842|NCT01654263|FG001|Participant Flow|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
11111843|NCT01654263|FG002|Participant Flow|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111844|NCT01654263|FG003|Participant Flow|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111845|NCT01654263|FG004|Participant Flow|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111846|NCT01654263|FG005|Participant Flow|IIBB: Age 65 - 74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111847|NCT01654263|OG000|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
11111848|NCT01654263|OG001|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111849|NCT01654263|OG002|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111850|NCT01654263|EG000|Reported Event|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
10846037|NCT00272337|FG004|Participant Flow|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
10846038|NCT00272337|OG000|Outcome|1 of 5 Randomized Treatment Arms|81 mg Aspirin
11111851|NCT01654263|EG001|Reported Event|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
11111852|NCT01654263|EG002|Reported Event|IIA: Previous PPSV23, Age 55-64, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111853|NCT01654263|EG003|Reported Event|IIB: Previous PPSV23, Age 65-74, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111854|NCT01654263|EG004|Reported Event|IIAA: Previous PPSV23, Age 55-64, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111855|NCT01654263|EG005|Reported Event|IIBB: Previous PPSV23, Age 65-74, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
11111856|NCT01654276|BG000|Baseline|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
11111857|NCT01654276|FG000|Participant Flow|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
11111858|NCT01654276|OG000|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
11111859|NCT01654276|EG000|Reported Event|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
11111860|NCT01654289|BG000|Baseline|Mindfulness Meditation|"Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.~Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation retreat on a weekend day at the end of week 6 will allow participants to practice their skills."
11111861|NCT01654289|BG001|Baseline|Exercise|"The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).~Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice."
11111862|NCT01654289|BG002|Baseline|Wait-list Control|"Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as experimental participants."
11111863|NCT01654289|BG003|Baseline|Total|Total of all reporting groups
11111864|NCT01654289|FG000|Participant Flow|Mindfulness Meditation|"Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.~Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation retreat on a weekend day at the end of week 6 will allow participants to practice their skills."
11111865|NCT01654289|FG001|Participant Flow|Exercise|"The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).~Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice."
11111866|NCT01654289|FG002|Participant Flow|Wait-list Control|"Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as experimental participants."
11111867|NCT01654289|OG000|Outcome|Mindfulness Meditation|"Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.~Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation retreat on a weekend day at the end of week 6 will allow participants to practice their skills."
11126691|NCT01734850|FG000|Participant Flow|Cohort 1 (CSL202 With No Busulfan)|Cal-1 modified Hematopoietic stem/progenitor cells (HSPC) and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
11126692|NCT01734850|FG001|Participant Flow|Cohort 2 (CSL202 With 1 Busulfan Dose)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11126693|NCT01734850|FG002|Participant Flow|Cohort 3 (CSL202 With 2 Busulfan Doses)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
10846039|NCT00272337|OG001|Outcome|2 of 5 Randomized Treatment Arms|162 mg Aspirin
10846040|NCT00272337|OG002|Outcome|3 of 5 Randomized Treatment Arms|325 mg Aspirin
11111868|NCT01654289|OG001|Outcome|Exercise|"The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).~Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice."
11111869|NCT01654289|OG002|Outcome|Wait-list Control|"Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as experimental participants."
11111870|NCT01654289|EG000|Reported Event|Mindfulness Meditation|"Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.~Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation retreat on a weekend day at the end of week 6 will allow participants to practice their skills."
11111871|NCT01654289|EG001|Reported Event|Exercise|"The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).~Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice."
11111872|NCT01654289|EG002|Reported Event|Wait-list Control|"Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as experimental participants."
11111873|NCT01654302|BG000|Baseline|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7).
11111874|NCT01654302|BG001|Baseline|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
11111875|NCT01654302|BG002|Baseline|Total|Total of all reporting groups
11111876|NCT01654302|FG000|Participant Flow|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).
11111877|NCT01654302|FG001|Participant Flow|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
11111878|NCT01654302|OG000|Outcome|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
11111879|NCT01654302|OG001|Outcome|Inactive Patch|placebo: placebo
11111880|NCT01654302|EG000|Reported Event|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
11111881|NCT01654302|EG001|Reported Event|Inactive Patch|placebo: placebo
11111882|NCT01654380|BG000|Baseline|Part A|All participants who received at least 1 dose of study drug in Part A of the study.
11111883|NCT01654380|BG001|Baseline|Part B|All participants who received at least 1 dose of study drug in Part B of the study.
11111884|NCT01654380|BG002|Baseline|Total|Total of all reporting groups
11111885|NCT01654380|FG000|Participant Flow|Part A, Cohort A: LY2605541 First, Then Insulin Glargine|"LY2605541: Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours.~Insulin glargine: Healthy participants received 30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4"
11111886|NCT01654380|FG001|Participant Flow|Part A, Cohort B: LY2605541 First, Then Insulin Glargine|"LY2605541: Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours.~Insulin glargine: Healthy participants received 20 mU/m^2/min administered IV over 8 hours in Period 4"
11111887|NCT01654380|FG002|Participant Flow|Part B: LY2605541|LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours.
11111888|NCT01654380|FG003|Participant Flow|Part B: Insulin Glargine|Insulin glargine: Participants with T1DM received 10 mU/m^2/min in 1 of 4 Periods and received 20 mU/m^2/min in 1 of 4 Periods, administered IV over 8 hours.
11111889|NCT01654380|OG000|Outcome|15.3 mU/Min LY2605541|LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods in Part B, administered IV for up to 8 hours
11111890|NCT01654380|OG001|Outcome|74.1 mU/Min LY2605541|LY2605541: Participants with T1DM received 74.1 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours
11111891|NCT01654380|OG002|Outcome|10 mU/m^2/Min Insulin Glargine|Insulin glargine: Participants with T1DM received 10 mU/m^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
11111892|NCT01654380|OG003|Outcome|20 mU/m^2/Min Insulin Glargine|Insulin glargine: Participants with T1DM received 20 mU/m^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
11111893|NCT01654380|EG000|Reported Event|Part A, Cohort A: 5.1 mU/Min LY2605541|LY2605541: Healthy participants received 5.1 mU/min in Period 1, administered IV over 8 hours
11111894|NCT01654380|EG001|Reported Event|Part A, Cohort A: 10.2 mU/Min LY2605541|LY2605541: Healthy participants received 10.2 mU/min in Period 2, administered IV over 8 hours
11126694|NCT01734850|OG000|Outcome|Cohort 1 (CSL202 With No Busulfan)|Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
11111895|NCT01654380|EG002|Reported Event|Part A, Cohort A or Cohort B: 15.3 mU/Min LY2605541|LY2605541: Healthy participants received 15.3 mU/min in Period 3 of Part A Cohort A and 15.3 mU/min in Period 1 of Part A Cohort B, administered IV over 8 hours
11111896|NCT01654380|EG003|Reported Event|Part A, Cohort A: 30 mU/m^2/Min Insulin Glargine|Insulin glargine: Healthy participants received 30 mU/m^2/min administered IV over 8 hours in Period 4
11111897|NCT01654380|EG004|Reported Event|Part A, Cohort B: 37.0 mU/Min LY2605541|LY2605541: Healthy participants received 37.0 mU/min in Period 2 administered IV over 8 hours
11111898|NCT01654380|EG005|Reported Event|Part A, Cohort B: 74.1 mU/Min LY2605541|LY2605541: Healthy participants received 74.1 mU/min in Period 3, administered IV over 8 hours
11111899|NCT01654380|EG006|Reported Event|Part A, Cohort B: 20 mU/m^2/Min Insulin Glargine|Insulin glargine: Healthy participants received 20 mU/m^2/min administered IV over 8 hours in Period 4
11111900|NCT01654380|EG007|Reported Event|Part B: 15.3 mU/Min LY2605541|LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours
11111901|NCT01654380|EG008|Reported Event|Part B: 74.1 mU/Min LY2605541|LY2605541: Participants with T1DM received 74.1 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours
11111902|NCT01654380|EG009|Reported Event|Part B: 10 mU/m^2/Min Insulin Glargine|Insulin glargine: Participants with T1DM received 10 mU/m^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
11111903|NCT01654380|EG010|Reported Event|Part B: 20 mU/m^2/Min Insulin Glargine|Insulin glargine: Participants with T1DM received 20 mU/m^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
11111904|NCT01654445|BG000|Baseline|Tenecteplase 0.1 mg/kg|25 patients treated with 0.1 mg/kg intravenous tenecteplase
11111905|NCT01654445|BG001|Baseline|Tenecteplase 0.25 mg/kg|25 patients treated with 0.25 mg/kg intravenous tenecteplase
11111906|NCT01654445|BG002|Baseline|Total|Total of all reporting groups
11111907|NCT01654445|FG000|Participant Flow|Tenecteplase 0.1 mg/kg|25 patients treated with 0.1 mg/kg intravenous tenecteplase
11111908|NCT01654445|FG001|Participant Flow|Tenecteplase 0.25 mg/kg|25 patients treated with 0.25 mg/kg intravenous tenecteplase
11111909|NCT01654445|OG000|Outcome|Tenecteplase 0.1 mg/kg|25 patients treated with 0.1 mg/kg intravenous tenecteplase
11111910|NCT01654445|OG001|Outcome|Tenecteplase 0.25 mg/kg|25 patients treated with 0.25 mg/kg intravenous tenecteplase
11111911|NCT01654445|EG000|Reported Event|Tenecteplase 0.1 mg/kg|25 patients treated with 0.1 mg/kg intravenous tenecteplase
11111912|NCT01654445|EG001|Reported Event|Tenecteplase 0.25 mg/kg|25 patients treated with 0.25 mg/kg intravenous tenecteplase
11111913|NCT01654523|BG000|Baseline|Treatment Arm|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
11111914|NCT01654523|FG000|Participant Flow|Awareness Enhancement and Monitoring Device|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
11111915|NCT01654523|OG000|Outcome|Awareness Enhancement and Monitoring Device|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
11111916|NCT01654523|EG000|Reported Event|Treatment Arm|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
11111917|NCT01654536|BG000|Baseline|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
11111918|NCT01654536|BG001|Baseline|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
11111919|NCT01654536|BG002|Baseline|Total|Total of all reporting groups
11111920|NCT01654536|FG000|Participant Flow|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
11111921|NCT01654536|FG001|Participant Flow|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
11111922|NCT01654536|OG000|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
11111923|NCT01654536|OG001|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
11111924|NCT01654536|OG000|Outcome|Ciclesonide Nasal Aerosol|"Zetona (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
11111925|NCT01654536|EG000|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
11111926|NCT01654536|EG001|Reported Event|Ciclesonide Nasal Spray|"ciclesonide nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
11111927|NCT01654549|BG000|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
11111928|NCT01654549|BG001|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
11111929|NCT01654549|BG002|Baseline|Total|Total of all reporting groups
11111930|NCT01654549|FG000|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
11111931|NCT01654549|FG001|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
11111932|NCT01654549|OG000|Outcome|Liver Fat Content in H.Pylori Eradication at Baseline|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at baseline
11111933|NCT01654549|OG001|Outcome|Liver Fat Content in H.Pylori Eradication at 8 Weeks|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at 8 weeks
11111934|NCT01654549|OG002|Outcome|Liver Fat Content in Lifestyle Modification at Baseline|Liver fat content in lifestyle modification group at baseline
11111935|NCT01654549|OG003|Outcome|Liver Fat Content in Lifestyle Modification at 8 Weeks|Liver fat content in lifestyle modification group at 8 weeks
11111936|NCT01654549|OG004|Outcome|Liver Fat Content Change in H.Pylori Eradication|The change of liver fat content from baseline to the end of study in H.pylori eradication group
11111937|NCT01654549|OG005|Outcome|Liver Fat Content Change in Lifestyle Modification|The change of liver fat content from baseline to the end of study in lifestyle modification group
11111938|NCT01654549|EG000|Reported Event|H. Pylori Eradication|Helicobacter pylori eradication
11111939|NCT01654549|EG001|Reported Event|No Intervention|Lifestyle modification
11111940|NCT01654601|BG000|Baseline|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
11111941|NCT01654601|BG001|Baseline|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
11111942|NCT01654601|BG002|Baseline|Total|Total of all reporting groups
11111943|NCT01654601|FG000|Participant Flow|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
11111944|NCT01654601|FG001|Participant Flow|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
11111945|NCT01654601|OG000|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
11111946|NCT01654601|OG001|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
11111947|NCT01654601|EG000|Reported Event|A Group|1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose
11111948|NCT01654601|EG001|Reported Event|B Group|1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose
11111949|NCT01654666|BG000|Baseline|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111950|NCT01654666|BG001|Baseline|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111951|NCT01654666|BG002|Baseline|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111952|NCT01654666|BG003|Baseline|Total|Total of all reporting groups
11111953|NCT01654666|FG000|Participant Flow|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111954|NCT01654666|FG001|Participant Flow|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111955|NCT01654666|FG002|Participant Flow|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111956|NCT01654666|OG000|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111957|NCT01654666|OG001|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111958|NCT01654666|OG002|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111959|NCT01654666|EG000|Reported Event|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111960|NCT01654666|EG001|Reported Event|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111961|NCT01654666|EG002|Reported Event|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
11111962|NCT01654796|BG000|Baseline|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
11111963|NCT01654796|BG001|Baseline|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
11111964|NCT01654796|BG002|Baseline|Crossover Arm|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
11111965|NCT01654796|BG003|Baseline|Total|Total of all reporting groups
11111966|NCT01654796|FG000|Participant Flow|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
11111967|NCT01654796|FG001|Participant Flow|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
11111968|NCT01654796|FG002|Participant Flow|Sham LFMS First, Then Active LFMS|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
11111969|NCT01654796|OG000|Outcome|Phase 1 Active LFMS|Participants in this group receive Active LFMS treatment for 2 days in Phase 1.
11111970|NCT01654796|OG001|Outcome|Phase 1 Sham LFMS|Participants in this group received Sham LFMS treatment for 2 days in Phase 1.
11111971|NCT01654796|OG002|Outcome|Phase 2 Active LFMS|Participants in this group received Active LFMS treatment for 2 days in Phase 2.
11111972|NCT01654796|OG003|Outcome|Phase 2 Sham LFMS|Participants in this group received Sham LFMS treatment for 2 days in Phase 2.
11111973|NCT01654796|EG000|Reported Event|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
11111974|NCT01654796|EG001|Reported Event|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
11111975|NCT01654796|EG002|Reported Event|Crossover Arm|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
10846041|NCT00272337|OG003|Outcome|4 of 5 Randomized Treatment Arms|650 mg Aspirin
10846042|NCT00272337|OG004|Outcome|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
11111976|NCT01654861|BG000|Baseline|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
11111977|NCT01654861|FG000|Participant Flow|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
11111978|NCT01654861|OG000|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
11111979|NCT01654861|EG000|Reported Event|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
11111980|NCT01654887|BG000|Baseline|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
11111981|NCT01654887|BG001|Baseline|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
11111982|NCT01654887|BG002|Baseline|Total|Total of all reporting groups
11111983|NCT01654887|FG000|Participant Flow|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
11111984|NCT01654887|FG001|Participant Flow|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
11111985|NCT01654887|OG000|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
11111986|NCT01654887|OG001|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
11111987|NCT01654887|OG000|Outcome|Lung Ultrasound|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
11111988|NCT01654887|EG000|Reported Event|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
11111989|NCT01654887|EG001|Reported Event|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
11111990|NCT01655043|BG000|Baseline|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
11111991|NCT01655043|FG000|Participant Flow|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
11111992|NCT01655043|OG000|Outcome|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
11111993|NCT01655043|EG000|Reported Event|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
11111994|NCT01655069|BG000|Baseline|Children Treated With Placebo in 905-CL-076|Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
11111995|NCT01655069|BG001|Baseline|Children Treated With Solifenacin in 905-CL-076|Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
11111996|NCT01655069|BG002|Baseline|Adolescents Treated With Placebo in 905-CL-076|Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
11111997|NCT01655069|BG003|Baseline|Adolescents Treated With Solifenacin in 905-CL-076|Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
11111998|NCT01655069|BG004|Baseline|Total|Total of all reporting groups
11111999|NCT01655069|FG000|Participant Flow|Children Treated With Placebo in 905-CL-076|Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
11112000|NCT01655069|FG001|Participant Flow|Children Treated With Solifenacin in 905-CL-076|Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
11112001|NCT01655069|FG002|Participant Flow|Adolescents Treated With Placebo in 905-CL-076|Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
11112002|NCT01655069|FG003|Participant Flow|Adolescents Treated With Solifenacin in 905-CL-076|Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
11126695|NCT01734850|OG001|Outcome|Cohort 2 (CSL202 With 1 Busulfan Dose)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11112003|NCT01655069|OG000|Outcome|Children (Aged 5 to Less Than 12 Years)|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
11112004|NCT01655069|OG001|Outcome|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
11112005|NCT01655069|OG000|Outcome|Children (Aged 5 to Less Than 12 Years)|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults
11112006|NCT01655069|OG000|Outcome|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
11112007|NCT01655069|EG000|Reported Event|Children (Aged 5 to Less Than 12 Years|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
11112008|NCT01655069|EG001|Reported Event|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
11112009|NCT01655329|BG000|Baseline|Radiologists|Board Certified Radiologists
11112010|NCT01655329|FG000|Participant Flow|Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images. The radiologists reviewed each radiograph using one or the alternate presentation
11112011|NCT01655329|OG000|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
11112012|NCT01655329|OG001|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
11112013|NCT01655329|OG000|Outcome|Reading Time Estimate by Radiologists|The modified image will reduce reading time.
11112014|NCT01655329|OG001|Outcome|Pleural Drain Visibility|Pleural drains are easier to see on the standard image.
11112015|NCT01655329|OG002|Outcome|Venous Catheters|Venous catheters easier to see on modified image
11112016|NCT01655329|OG003|Outcome|Cardiac Related Wires|Cardiac related wires are easier to see on the standard image
11112017|NCT01655329|OG004|Outcome|Overall Image Quality|Overall image quality is superior on the standard image
11112018|NCT01655329|OG005|Outcome|Image Quality Radioopaque Regions|Image quality in the opaque image areas is superior on the confirm image
11112019|NCT01655329|OG006|Outcome|Confidence on Line Placement|The modified image increased my confidence with respect to line placement
11112020|NCT01655329|OG007|Outcome|Need for Window/Level Manipulation|The standard image required less window/level manipulation
11112021|NCT01655329|OG008|Outcome|Confidence on Tube Placement|The confirm image increases my confidence with respect to tube placement.
11112022|NCT01655329|EG000|Reported Event|Radiologists|
11112023|NCT01655381|BG000|Baseline|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
11112024|NCT01655381|FG000|Participant Flow|Tocilizumab|Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks.
11112025|NCT01655381|OG000|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
11112026|NCT01655381|OG000|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
11112027|NCT01655381|EG000|Reported Event|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
11112028|NCT01655498|BG000|Baseline|All Subjects|All subjects who completed the fitting process (a screening criteria) and entered the treatment period.
11112029|NCT01655498|FG000|Participant Flow|All Subjects|All subjects who completed the fitting process and entered the treatment period, comprised the Intent-to-treat population.
11112030|NCT01655498|OG000|Outcome|Subjects Fit With the VBC Device [ITT]|ITT cohort is defined as all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period
11112031|NCT01655498|OG001|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
11112032|NCT01655498|OG000|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
11112033|NCT01655498|OG000|Outcome|ITT Cohort [N=61]|All subjects who entered the Treatment Period.
11112034|NCT01655498|EG000|Reported Event|ITT Cohort [N=61]|Adverse Events reported during the Screening and 1-Month Treatment Period.
11112035|NCT01655563|BG000|Baseline|Standard Dosing Arm|"Patients in the standard arm will receive standard starting dose of tacrolimus that is clinically used i.e. 0.1 mg/kg/dose twice a day.~Tacrolimus: Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5."
11112036|NCT01655563|BG001|Baseline|Pharmacogenetic Arm|Patients in the pharmacogenetic arm will receive a starting dose that is assigned based on age and CYP3A5 expressor status. Patients that are CYP3A5 expressors will receive the higher end of the dose range compared to non-expressors as described in Table 1. All doses recommended in Table 1 represent clinically acceptable and safe dose ranges used at our institution. This proposed pharmacogenetic dosing algorithm is derived from a validated algorithm published in pediatric renal transplant patients.
11112037|NCT01655563|BG002|Baseline|Total|Total of all reporting groups
11112038|NCT01655563|FG000|Participant Flow|Standard Dosing Arm|"Patients in the standard arm will receive standard starting dose of tacrolimus that is clinically used i.e. 0.1 mg/kg/dose twice a day.~Tacrolimus: Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5."
11112039|NCT01655563|FG001|Participant Flow|Pharmacogenetic Arm|"Patients in the pharmacogenetic arm will receive a starting dose that is assigned based on age and CYP3A5 expressor status. Patients that are CYP3A5 expressors will receive the higher end of the dose range compared to non-expressors. All doses recommended represent clinically acceptable and safe dose ranges used at our institution.~CYP3A5 non-expressor starting dose:~Greater than 6 years of age - 0.075 mg/kg/dose q12 hours; Less than or equal to 6 years of age - 0.1 mg/kg/dose q12 hours~CYP3A5 expressor starting dose:~Greater than 6 years of age - 0.15 mg/kg/dose q12 hours; Less than or equal to 6 years of age - 0.2 mg/kg/dose q12 hours"
11112040|NCT01655563|OG000|Outcome|Standard Dosing Arm|"Patients in the standard arm will receive standard starting dose of tacrolimus that is clinically used i.e. 0.1 mg/kg/dose twice a day.~Tacrolimus: Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5."
11112041|NCT01655563|OG001|Outcome|Pharmacogenetic Arm|"Patients in the pharmacogenetic arm will receive a starting dose that is assigned based on age and CYP3A5 expressor status. Patients that are CYP3A5 expressors will receive the higher end of the dose range compared to non-expressors. All doses recommended represent clinically acceptable and safe dose ranges used at our institution.~CYP3A5 non-expressor starting dose:~Greater than 6 years of age - 0.075 mg/kg/dose q12 hours; Less than or equal to 6 years of age - 0.1 mg/kg/dose q12 hours~CYP3A5 expressor starting dose:~Greater than 6 years of age - 0.15 mg/kg/dose q12 hours; Less than or equal to 6 years of age - 0.2 mg/kg/dose q12 hours"
11112042|NCT01655563|EG000|Reported Event|Standard Dosing Arm|"Patients in the standard arm will receive standard starting dose of tacrolimus that is clinically used i.e. 0.1 mg/kg/dose twice a day.~Tacrolimus: Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5."
11112043|NCT01655563|EG001|Reported Event|Pharmacogenetic Arm|Patients in the pharmacogenetic arm will receive a starting dose that is assigned based on age and CYP3A5 expressor status. Patients that are CYP3A5 expressors will receive the higher end of the dose range compared to non-expressors as described in Table 1. All doses recommended in Table 1 represent clinically acceptable and safe dose ranges used at our institution. This proposed pharmacogenetic dosing algorithm is derived from a validated algorithm published in pediatric renal transplant patients.
11112044|NCT01655693|BG000|Baseline|Doxorubicin Transdrug (DT) at 20 mg/m2|DT was infused over 6 hours through the intravenous (IV) route at dose of 20 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112045|NCT01655693|BG001|Baseline|Doxorubicin Transdrug at 30 mg/m2|DT was infused over 6 hours through the IV route at dose of 30 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112046|NCT01655693|BG002|Baseline|Best Standard of Care|Patients randomized in the control group received treatment according to the investigator's choice, until disease progression or unacceptable toxicity.
11112047|NCT01655693|BG003|Baseline|Total|Total of all reporting groups
11112048|NCT01655693|FG000|Participant Flow|Doxorubicin Transdrug (DT) at 20 mg/m2|DT was infused over 6 hours through the intravenous (IV) route at dose of 20 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112049|NCT01655693|FG001|Participant Flow|Doxorubicin Transdrug at 30 mg/m2|DT was infused over 6 hours through the IV route at dose of 30 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112050|NCT01655693|FG002|Participant Flow|Best Standard of Care|Patients randomized in the control group received treatment according to the investigator's choice, until disease progression or unacceptable toxicity.
11112051|NCT01655693|OG000|Outcome|Doxorubicin Transdrug (DT) 20 mg/m2 Group|DT was infused over 6 hours through the intravenous route at dose of 20 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112052|NCT01655693|OG001|Outcome|Doxorubicin Transdrug at 30 mg/m2|DT was infused over 6 hours through the IV route at dose of 30 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112053|NCT01655693|OG002|Outcome|Doxorubicin Transdrug Pooled|The DT 20 mg/m2 and 30 mg/m2 treatment group were pooled together for OS comparison to Best Standard of Care (BCS) for initial study.
11112054|NCT01655693|OG003|Outcome|Best Standard of Care (BSC)|Patients randomized in the control group received treatment according to the investigator's choice, until disease progression or unacceptable toxicity in initial study.
11112055|NCT01655693|OG000|Outcome|Doxorubicin Transdrug (DT) at 20 mg/m2|DT was infused over 6 hours through the intravenous (IV) route at dose of 20 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112056|NCT01655693|OG002|Outcome|Doxorubicin Transdrug Pooled|The DT 20 mg/m2 and 30 mg/m2 treatment group were pooled together for PFS comparison to BCS.
11112057|NCT01655693|OG003|Outcome|Best Standard of Care|Patients randomized in the control group received treatment according to the investigator's choice, until disease progression or unacceptable toxicity.
11112058|NCT01655693|OG001|Outcome|Doxorubicin Transdrug at 30 mg/m2|"DT will be infused over 6 hours through the IV route at dose of 30 mg/m2 on Day 1 and will be repeated every 4 weeks until disease progression or unacceptable toxicity~Doxorubicin"
11112059|NCT01655693|OG002|Outcome|Doxorubicin Transdrug Pooled|The DT 20 mg/m2 and 30 mg/m2 treatment group were pooled together for ORR comparison to BCS.
11112060|NCT01655693|OG003|Outcome|Best Standard of Care|"Patients randomized in the control group will receive treatment according to the investigator's choice, until disease progression or unacceptable toxicity~Best Standard of Care"
11112061|NCT01655693|OG002|Outcome|Best Standard of Care (BSC)|Patients randomized in the control group received treatment according to the investigator's choice, until disease progression or unacceptable toxicity.
11112062|NCT01655693|OG000|Outcome|Doxorubicin Transdrug (DT) 20 mg/m2|DT was infused over 6 hours through the intravenous (IV) route at dose of 20 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112063|NCT01655693|OG001|Outcome|Doxorubicin Transdrug 30 mg/m2|DT was infused over 6 hours through the IV route at dose of 30 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112064|NCT01655693|EG000|Reported Event|Doxorubicin Transdrug (DT) at 20 mg/m2|DT was infused over 6 hours through the intravenous (IV) route at dose of 20 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112065|NCT01655693|EG001|Reported Event|Doxorubicin Transdrug at 30 mg/m2|DT was infused over 6 hours through the IV route at dose of 30 mg/m2 on Day 1 and was repeated every 4 weeks until disease progression or unacceptable toxicity.
11112066|NCT01655693|EG002|Reported Event|Best Standard of Care|Patients randomized in the control group received treatment according to the investigator's choice, until disease progression or unacceptable toxicity.
11112067|NCT01655719|BG000|Baseline|Pioglitazone Treatment|Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
11112068|NCT01655719|FG000|Participant Flow|Pioglitazone Treatment|"If eligible, subjects can participate in 1 or both parts of this study as follows:~Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.~Part 2: A secondary protocol is then available to subjects who complete the main initial study with less than complete response per RECIST. They can undergo a radioiodine scan to see if the treatment with pioglitazone has sensitized their disease to radioiodine. If it has - they can pursue the radioiodine treatment.~Pioglitazone"
11112069|NCT01655719|OG000|Outcome|Pioglitazone Treatment|Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
11112070|NCT01655719|EG000|Reported Event|Pioglitazone Treatment|Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
11112071|NCT01655823|BG000|Baseline|Placebo (Twice Daily)|"Placebo for injection (1 ml volume), twice a day for four consecutive days.~Placebo: Sham treatment acting as control arm"
11112072|NCT01655823|BG001|Baseline|Low Dose Tetrodotoxin (Twice Daily)|"Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112073|NCT01655823|BG002|Baseline|Mid-range Dose of Tetrodotoxin (Twice Daily)|"Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112074|NCT01655823|BG003|Baseline|Max Dose Tetrodotoxin (Once Daily)|"Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.~Placebo: Sham treatment acting as control arm~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112075|NCT01655823|BG004|Baseline|Max Dose Tetrodotoxin (Twice Daily)|"Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112076|NCT01655823|BG005|Baseline|Total|Total of all reporting groups
11112077|NCT01655823|FG000|Participant Flow|Placebo (Twice Daily)|"Placebo for injection (1 ml volume), twice a day for four consecutive days.~Placebo: Sham treatment acting as control arm"
11112078|NCT01655823|FG001|Participant Flow|Low Dose Tetrodotoxin (Twice Daily)|"Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112079|NCT01655823|FG002|Participant Flow|Mid-range Dose of Tetrodotoxin (Twice Daily)|"Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112080|NCT01655823|FG003|Participant Flow|Max Dose Tetrodotoxin (Once Daily)|"Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.~Placebo: Sham treatment acting as control arm~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112081|NCT01655823|FG004|Participant Flow|Max Dose Tetrodotoxin (Twice Daily)|"Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112082|NCT01655823|OG000|Outcome|Placebo (Twice Daily)|"Placebo for injection (1 ml volume), twice a day for four consecutive days.~Placebo: Sham treatment acting as control arm"
11112083|NCT01655823|OG001|Outcome|Low Dose Tetrodotoxin (Twice Daily)|"Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112084|NCT01655823|OG002|Outcome|Mid-range Dose of Tetrodotoxin (Twice Daily)|"Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112085|NCT01655823|OG003|Outcome|Max Dose Tetrodotoxin (Once Daily)|"Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.~Placebo: Sham treatment acting as control arm~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112086|NCT01655823|OG004|Outcome|Max Dose Tetrodotoxin (Twice Daily)|"Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112087|NCT01655823|EG000|Reported Event|Placebo (Twice Daily)|"Placebo for injection (1 ml volume), twice a day for four consecutive days.~Placebo: Sham treatment acting as control arm"
11112088|NCT01655823|EG001|Reported Event|Low Dose Tetrodotoxin (Twice Daily)|"Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112089|NCT01655823|EG002|Reported Event|Mid-range Dose of Tetrodotoxin (Twice Daily)|"Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112090|NCT01655823|EG003|Reported Event|Max Dose Tetrodotoxin (Once Daily)|"Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.~Placebo: Sham treatment acting as control arm~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112091|NCT01655823|EG004|Reported Event|Max Dose Tetrodotoxin (Twice Daily)|"Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.~Tetrodotoxin: Comparison of different dosages of Tetrodotoxin"
11112092|NCT01655901|BG000|Baseline|Video Game Condition|"Playing Kinect~Playing Xbox 360~Sitting on a chair (control)"
11112093|NCT01655901|FG000|Participant Flow|Kinect, Then Xbox360, Then Sitting|Participants played Kinect for 1 hour at 10:20am. After a wash-out period of 1 week, they then played Xbox360 for 1 hour at 10:20am. After a second wash-out period of 1 week they then sat on a chair for 1 hour at 10:20am.
11112094|NCT01655901|FG001|Participant Flow|Kinect, Then Sitting, Then Xbox360|Participants played Kinect for 1 hour at 10:20am. After a wash-out period of 1 week, they then sat on a chair for 1 hour at 10:20am. After a second wash-out period of 1 week they then played Xbox360 for 1 hour at 10:20am.
11112095|NCT01655901|FG002|Participant Flow|Xbox360, Then Sitting, Then Kinect|Participants played Xbox360 for 1 hour at 10:20am. After a wash-out period of 1 week, they then sat on a chair for 1 hour at 10:20am. After a second wash-out period of 1 week they then played Kinect for 1 hour at 10:20am.
11112096|NCT01655901|FG003|Participant Flow|Xbox360, Then Kinect, Then Sitting|Participants played Xbox360 for 1 hour at 10:20am. After a wash-out period of 1 week, they then played Kinect for 1 hour at 10:20am. After a second wash-out period of 1 week they then sat on a chair for 1 hour at 10:20am.
10846043|NCT00272337|EG000|Reported Event|1 of 5 Randomized Treatment Arms|81 mg Aspirin
11112097|NCT01655901|FG004|Participant Flow|Sitting, Then Kinect, Then Xbox360|Participants sat on a chair for 1 hour at 10:20am. After a wash-out period of 1 week, they then played Kinect for 1 hour at 10:20am. After a second wash-out period of 1 week they then played Xbox360 for 1 hour at 10:20am.
11112098|NCT01655901|FG005|Participant Flow|Sitting, Then Xbox360, Then Kinect|Participants sat on a chair for 1 hour at 10:20am. After a wash-out period of 1 week, they then played Xbox360 for 1 hour at 10:20am. After a second wash-out period of 1 week they then played Kinect for 1 hour at 10:20am.
11112099|NCT01655901|OG000|Outcome|All Study Participants|Active video gaming (Kinect) Passive video gaming (Xbox360) Sitting on a chair (control)
11112100|NCT01655901|OG000|Outcome|All Study Participants|"Active video gaming (Kinect)~Passive video gaming (Xbox360)~Resting (control)"
11112101|NCT01655901|OG000|Outcome|All Study Participants|"Active video gaming (Kinect)~Passive video gaming (Xbox)~Resting (control)"
11112102|NCT01655901|OG000|Outcome|All Study Participants|"Active video gaming (Kinect)~Passive video gaming (Xbox 360)~Resting (control)"
11112103|NCT01655901|EG000|Reported Event|Kinect|Participants played Kinect for 1 hour at 10:20am.
11112104|NCT01655901|EG001|Reported Event|Xbox360|Participants played Xbox360 for 1 hour at 10:20am.
11112105|NCT01655901|EG002|Reported Event|Sitting|Participants sat for 1 hour at 10:20am.
11112106|NCT01656031|BG000|Baseline|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
11112107|NCT01656031|FG000|Participant Flow|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
11112108|NCT01656031|OG000|Outcome|High-Dose Cytarabine and Clofarabine|
11112109|NCT01656031|EG000|Reported Event|High-Dose Cytarabine and Clofarabine|
11112110|NCT01656161|BG000|Baseline|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
11112111|NCT01656161|FG000|Participant Flow|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
11112112|NCT01656161|OG000|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
11112113|NCT01656161|OG000|Outcome|PK/PD Subset|Pharmacokinetic/pharmacodynamic (PK/PD) subset of 15 participants included in the ITT analysis set.
11112114|NCT01656161|OG000|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
11112115|NCT01656161|OG000|Outcome|PK/PD Subset of 15 Participants|Pharmacokinetic/pharmacodynamic subset of 15 participants who received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
11112116|NCT01656161|EG000|Reported Event|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
11112117|NCT01656187|BG000|Baseline|Memantine, Then Placebo|"Participants received Memantine 10 mg capsule twice/day for 24 weeks, then underwent a 4-week washout period, then received memantine-matched placebo capsule twice/day for 24 weeks.~Memantine oral capsule was initiated at 5 mg/day at Week 0, then titrated to 5 mg twice/day at Week 2, then increased to 10 mg in the morning and 5 mg in the evening at Week 3, and then to 10 mg twice/day at Weeks 4-24. For the participants in the Placebo, then Memantine arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52).~Memantine-matched oral Placebo capsule was initiated at Week 0 and maintained Weeks 0-24 in a manner consistent with the active drug titration schedule. The number of placebo capsules matched the number of active drug capsules at each titration checkpoint. For the participants in the Memantine, then Placebo arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52)."
11112118|NCT01656187|BG001|Baseline|Placebo, Then Memantine|"Participants received Placebo capsule (matching Memantine 10 mg capsule) twice/day for 24 weeks. After a washout period of 4 weeks, they received Memantine 10 mg capsule twice a day for 24 weeks.~Memantine oral capsule was initiated at 5 mg/day at Week 0, then titrated to 5 mg twice a day at Week 2, then increased to 10 mg in the morning and 5 mg in the evening at Week 3, and then to 10 mg twice a day (intervention dose) at Weeks 4-24. For the participants in the Placebo, then Memantine arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52).~Memantine-matched oral Placebo capsule was initiated at Week 0 and maintained Weeks 0-24 in a manner consistent with the active drug titration schedule. The number of placebo capsules matched the number of active drug capsules at each titration checkpoint. For the participants in the Memantine, then Placebo arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52)."
11112119|NCT01656187|BG002|Baseline|Total|Total of all reporting groups
11112120|NCT01656187|FG000|Participant Flow|Memantine, Then Placebo|Participants first received Memantine 10 mg capsule twice a day for 24 weeks. After a washout period of 4 weeks, they then received Placebo capsule (matching Memantine 10 mg capsule) twice a day for 24 weeks
11112121|NCT01656187|FG001|Participant Flow|Placebo, Then Memantine|Participants first received Placebo capsule (matching Memantine 10 mg capsule) twice a day for 24 weeks. After a washout period of 4 weeks, they then received Memantine 10 mg capsule twice a day for 24 weeks.
11112122|NCT01656187|OG000|Outcome|Memantine|Participants who received Memantine 10 mg capsule twice per day in either the first or last 24 weeks of the study.
11112123|NCT01656187|OG001|Outcome|Placebo|Participants who received placebo capsule (matching Memantine 10 mg) twice per day in either the first or last 24 weeks of the study.
11112124|NCT01656187|EG000|Reported Event|Memantine|Participants who received Memantine 10 mg capsule twice per day for 24 weeks.
11112125|NCT01656187|EG001|Reported Event|Placebo|Participants who received Placebo capsule (matching Memantine 10 mg capsule) twice per day for 24 weeks.
11112126|NCT01656200|BG000|Baseline|Vaccine|"Single dose live attenuated Japanese encephalitis vaccine SA14-14-2~Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2"
11112127|NCT01656200|FG000|Participant Flow|Vaccine|"Single dose live attenuated Japanese encephalitis vaccine SA14-14-2~Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2"
11112128|NCT01656200|OG000|Outcome|Vaccine|"Single dose live attenuated Japanese encephalitis vaccine SA14-14-2~Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2"
11112129|NCT01656200|EG000|Reported Event|Vaccine|"Single dose live attenuated Japanese encephalitis vaccine SA14-14-2~Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2"
10846044|NCT00272337|EG001|Reported Event|2 of 5 Randomized Treatment Arms|162 mg Aspirin
10846045|NCT00272337|EG002|Reported Event|3 of 5 Randomized Treatment Arms|325 mg Aspirin
10846046|NCT00272337|EG003|Reported Event|4 of 5 Randomized Treatment Arms|650 mg Aspirin
11112130|NCT01656252|BG000|Baseline|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
11112131|NCT01656252|FG000|Participant Flow|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
11112132|NCT01656252|OG000|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
11112133|NCT01656252|OG001|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
11112134|NCT01656252|OG002|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
11112135|NCT01656252|EG000|Reported Event|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
11112136|NCT01656304|BG000|Baseline|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
11112137|NCT01656304|FG000|Participant Flow|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
11112138|NCT01656304|OG000|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
11112139|NCT01656304|EG000|Reported Event|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
11112140|NCT01656395|BG000|Baseline|MK-1029 10 mg|Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
11112141|NCT01656395|BG001|Baseline|MK-1029 30 mg|Participants receive MK-1029 30 mg tablets QD for 12 weeks
11112142|NCT01656395|BG002|Baseline|MK-1029 60 mg|Participants receive MK-1029 two 30 mg tablets QD for 12 weeks
11112143|NCT01656395|BG003|Baseline|MK-1029 150 mg|Participants receive MK-1029 150 mg tablets QD for 12 weeks
11112144|NCT01656395|BG004|Baseline|Montelukast 10 mg|Participants receive Montelukast 10 mg tablets QD for 12 weeks
11112145|NCT01656395|BG005|Baseline|Placebo|Participants receive Placebo tablets QD for 12 weeks
11112146|NCT01656395|BG006|Baseline|Total|Total of all reporting groups
11112147|NCT01656395|FG000|Participant Flow|MK-1029 10 mg|Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
11112148|NCT01656395|FG001|Participant Flow|MK-1029 30 mg|Participants receive MK-1029 30 mg tablets QD for 12 weeks
11112149|NCT01656395|FG002|Participant Flow|MK-1029 60 mg|Participants receive MK-1029 two 30 mg tablets QD for 12 weeks
11112150|NCT01656395|FG003|Participant Flow|MK-1029 150 mg|Participants receive MK-1029 150 mg tablets QD for 12 weeks
11112151|NCT01656395|FG004|Participant Flow|Montelukast 10 mg|Participants receive Montelukast 10 mg tablets QD for 12 weeks
11112152|NCT01656395|FG005|Participant Flow|Placebo|Participants receive Placebo tablets QD for 12 weeks
11112153|NCT01656395|FG006|Participant Flow|MK-1029 1 mg or 3 mg|Participants were to receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD. No participants were enrolled in this arm.
11112154|NCT01656395|FG007|Participant Flow|Montelukast 10 mg + MK-1029|Participants were to receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD. No participants were enrolled in this arm.
11112155|NCT01656395|OG000|Outcome|MK-1029 10 mg|Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
11112156|NCT01656395|OG001|Outcome|MK-1029 30 mg|Participants receive MK-1029 30 mg tablets QD for 12 weeks
11112157|NCT01656395|OG002|Outcome|MK-1029 60 mg|Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
11112158|NCT01656395|OG003|Outcome|MK-1029 150 mg|Participants will receive MK-1029 150 mg tablets QD for 12 weeks
11112159|NCT01656395|OG004|Outcome|Montelukast 10 mg|Participants will receive Montelukast 10 mg tablets QD for 12 weeks
11112160|NCT01656395|OG005|Outcome|Placebo|Participants will receive Placebo tablets QD for 12 weeks
11112161|NCT01656395|EG000|Reported Event|MK-1029 10 mg|Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
11112162|NCT01656395|EG001|Reported Event|MK-1029 30 mg|Participants receive MK-1029 30 mg tablets QD for 12 weeks
11112163|NCT01656395|EG002|Reported Event|MK-1029 60 mg|Participants receive MK-1029 two 30 mg tablets QD for 12 weeks
11112164|NCT01656395|EG003|Reported Event|MK-1029 150 mg|Participants receive MK-1029 150 mg tablets QD for 12 weeks
11112165|NCT01656395|EG004|Reported Event|Montelukast 10 mg|Participants receive Montelukast 10 mg tablets QD for 12 weeks
11112166|NCT01656395|EG005|Reported Event|Placebo|Participants receive Placebo tablets QD for 12 weeks
11112167|NCT01656408|BG000|Baseline|Panel A - Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
11112168|NCT01656408|BG001|Baseline|Panel B - Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
11112169|NCT01656408|BG002|Baseline|Panel C - Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
11112170|NCT01656408|BG003|Baseline|Panel D - Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
11112171|NCT01656408|BG004|Baseline|Panel E - Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
11112172|NCT01656408|BG005|Baseline|Panel F - Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
11112173|NCT01656408|BG006|Baseline|Panel G - Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
11112174|NCT01656408|BG007|Baseline|Panel H - Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
11112175|NCT01656408|BG008|Baseline|Panel I - Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
11112176|NCT01656408|BG009|Baseline|Panel J - Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
11112177|NCT01656408|BG010|Baseline|Total|Total of all reporting groups
11112178|NCT01656408|FG000|Participant Flow|Panel A - Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
11112179|NCT01656408|FG001|Participant Flow|Panel B - Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
11112180|NCT01656408|FG002|Participant Flow|Panel C - Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
11112181|NCT01656408|FG003|Participant Flow|Panel D - Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
11112182|NCT01656408|FG004|Participant Flow|Panel E - Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
11112183|NCT01656408|FG005|Participant Flow|Panel F - Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
11112184|NCT01656408|FG006|Participant Flow|Panel G - Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
11112185|NCT01656408|FG007|Participant Flow|Panel H - Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
11112186|NCT01656408|FG008|Participant Flow|Panel I - Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
11112187|NCT01656408|FG009|Participant Flow|Panel J - Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
11112188|NCT01656408|OG000|Outcome|Panel A - MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
11112189|NCT01656408|OG001|Outcome|Panel B - MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
11112190|NCT01656408|OG002|Outcome|Panel C - MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
11112191|NCT01656408|OG003|Outcome|Panel D - MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
11112192|NCT01656408|OG004|Outcome|Panel E - MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
11112193|NCT01656408|OG005|Outcome|Panel F - MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
11112194|NCT01656408|OG006|Outcome|Panel G - MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
11112195|NCT01656408|OG007|Outcome|Panel H - MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
11112196|NCT01656408|OG008|Outcome|Panel I - MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
11112197|NCT01656408|OG009|Outcome|Panel J - MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
11112198|NCT01656408|OG010|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
11112199|NCT01656408|OG011|Outcome|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
11112200|NCT01656408|OG012|Outcome|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
11112201|NCT01656408|OG004|Outcome|Panel A/B/C/D - Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
11112202|NCT01656408|OG000|Outcome|Panel E - MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
11112203|NCT01656408|OG001|Outcome|Panel E - Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
11112204|NCT01656408|OG000|Outcome|Panel F - MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
11112205|NCT01656408|OG001|Outcome|Panel F - Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
11112206|NCT01656408|OG000|Outcome|Panel G - MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
11112207|NCT01656408|OG001|Outcome|Panel G - Placebo|Placebo once daily on Days 1-28
11112208|NCT01656408|OG000|Outcome|Panel H - MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
11112209|NCT01656408|OG001|Outcome|Panel H - Placebo|Placebo once daily on Days 1-10
11112210|NCT01656408|OG000|Outcome|Panel I - MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
11112211|NCT01656408|OG001|Outcome|Panel I - Placebo|Placebo once daily on Days 1-28
11112212|NCT01656408|OG000|Outcome|Panel J - MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
11112213|NCT01656408|OG001|Outcome|Panel J - Placebo|Placebo once daily on Days 1-28
11112214|NCT01656408|OG000|Outcome|Panel E - MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
11112215|NCT01656408|OG001|Outcome|Panel F - MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
11112216|NCT01656408|OG000|Outcome|Panel E - MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
11112217|NCT01656408|OG001|Outcome|Panel F - MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
11112218|NCT01656408|OG001|Outcome|Panel J - MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
11112219|NCT01656408|EG000|Reported Event|Panel A - MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
11112220|NCT01656408|EG001|Reported Event|Panel B - MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
11112221|NCT01656408|EG002|Reported Event|Panel C - MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
11112222|NCT01656408|EG003|Reported Event|Panel D - MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
11112223|NCT01656408|EG004|Reported Event|Panel E - MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
11112224|NCT01656408|EG005|Reported Event|Panel F - MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
11112225|NCT01656408|EG006|Reported Event|Panel G - MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
11112226|NCT01656408|EG007|Reported Event|Panel H - MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
11112227|NCT01656408|EG008|Reported Event|Panel I - MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
11112228|NCT01656408|EG009|Reported Event|Panel J - MK-8150 10/20 mgEdit|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
11112229|NCT01656408|EG010|Reported Event|Placebo (Panel A - J)|Combines participants who received placebo in all panels
11112230|NCT01656408|EG011|Reported Event|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
11112231|NCT01656408|EG012|Reported Event|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
11112232|NCT01656460|BG000|Baseline|Stereotactic Radiation|stereotactic
11112233|NCT01656460|FG000|Participant Flow|Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
11112234|NCT01656460|FG001|Participant Flow|Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
11112235|NCT01656460|FG002|Participant Flow|Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
11112236|NCT01656460|FG003|Participant Flow|Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
11112237|NCT01656460|OG000|Outcome|Arm 1-Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
11112238|NCT01656460|OG001|Outcome|Arm 2-Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
11112239|NCT01656460|OG002|Outcome|Arm 3-Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
11112240|NCT01656460|OG003|Outcome|Arm 4-Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
11112241|NCT01656460|EG000|Reported Event|Arm 1-Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
11112242|NCT01656460|EG001|Reported Event|Arm 2-Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
11112243|NCT01656460|EG002|Reported Event|Arm 3-Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
11112244|NCT01656460|EG003|Reported Event|Arm 4-Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
11112245|NCT01656629|BG000|Baseline|Teriparatide|"teriparatide 20 mcg sq for 3 months~Teriparatide: 20 mcg subq daily for 3 months"
11112246|NCT01656629|BG001|Baseline|Alendronate|"70 mg po weekly for 3 months~Alendronate: 70 mg weekly for 3 months"
11112247|NCT01656629|BG002|Baseline|Calcium and Vitamin D|"calcium 630 mg vitamin D 500 units daily for 3 months~calcium and vitamin D"
11112248|NCT01656629|BG003|Baseline|Total|Total of all reporting groups
11112249|NCT01656629|FG000|Participant Flow|Teriparatide|"teriparatide 20 mcg sq for 3 months~Teriparatide: 20 mcg subq daily for 3 months"
11112250|NCT01656629|FG001|Participant Flow|Alendronate|"70 mg po weekly for 3 months~Alendronate: 70 mg weekly for 3 months"
11112251|NCT01656629|FG002|Participant Flow|Calcium and Vitamin D|"calcium 630 mg vitamin D 500 units daily for 3 months~calcium and vitamin D"
11112252|NCT01656629|OG000|Outcome|Teriparatide|"teriparatide 20 mcg sq for 3 months~Teriparatide: 20 mcg subq daily for 3 months"
11112253|NCT01656629|OG001|Outcome|Alendronate|"70 mg po weekly for 3 months~Alendronate: 70 mg weekly for 3 months"
11112254|NCT01656629|OG002|Outcome|Calcium and Vitamin D|"calcium 630 mg vitamin D 500 units daily for 3 months~calcium and vitamin D"
11112255|NCT01656629|EG000|Reported Event|Teriparatide|"teriparatide 20 mcg sq for 3 months~Teriparatide: 20 mcg subq daily for 3 months"
11112256|NCT01656629|EG001|Reported Event|Alendronate|"70 mg po weekly for 3 months~Alendronate: 70 mg weekly for 3 months"
11112257|NCT01656629|EG002|Reported Event|Calcium and Vitamin D|"calcium 630 mg vitamin D 500 units daily for 3 months~calcium and vitamin D"
11112258|NCT01656733|BG000|Baseline|Placebo Inhaler|Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
11112259|NCT01656733|BG001|Baseline|Nicotrol Inhaler|Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
11112260|NCT01656733|BG002|Baseline|Total|Total of all reporting groups
11112261|NCT01656733|FG000|Participant Flow|Placebo Inhaler|"Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper~Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper."
11112262|NCT01656733|FG001|Participant Flow|Nicotrol Inhaler|"Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.~Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper."
11112263|NCT01656733|OG000|Outcome|Placebo Inhaler|Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
11112264|NCT01656733|OG001|Outcome|Nicotrol Inhaler|Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
11112265|NCT01656733|EG000|Reported Event|Placebo Inhaler|"Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper~Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper."
11112266|NCT01656733|EG001|Reported Event|Nicotrol Inhaler|"Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.~Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper."
11112267|NCT01656759|BG000|Baseline|Control Group|Control group. Will not receive the fibrin spray.
11112268|NCT01656759|BG001|Baseline|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
11112269|NCT01656759|BG002|Baseline|Total|Total of all reporting groups
11112270|NCT01656759|FG000|Participant Flow|Control Group|Control group. Will not receive the fibrin spray.
11112271|NCT01656759|FG001|Participant Flow|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
11112272|NCT01656759|OG000|Outcome|Control Group|Control group. Will not receive the fibrin spray.
11112273|NCT01656759|OG001|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
11112274|NCT01656759|EG000|Reported Event|Control Group|Control group. Will not receive the fibrin spray.
11112275|NCT01656759|EG001|Reported Event|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
11112276|NCT01656772|BG000|Baseline|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
11112277|NCT01656772|BG001|Baseline|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
11112278|NCT01656772|BG002|Baseline|Total|Total of all reporting groups
11112279|NCT01656772|FG000|Participant Flow|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
11112280|NCT01656772|FG001|Participant Flow|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
11112281|NCT01656772|OG000|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
11112282|NCT01656772|OG001|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
11112283|NCT01656772|EG000|Reported Event|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
11112284|NCT01656772|EG001|Reported Event|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
11126696|NCT01734850|OG002|Outcome|Cohort 3 (CSL202 With 2 Busulfan Doses)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11126697|NCT01734850|OG002|Outcome|Cohort 3 (CSL202 With 2 Busulfan Doses)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11126698|NCT01734850|OG000|Outcome|Cohort 2 (CSL202 With 1 Busulfan Dose)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
10846047|NCT00272337|EG004|Reported Event|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
11126699|NCT01734850|OG001|Outcome|Cohort 3 (CSL202 With 2 Busulfan Doses)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11126700|NCT01734850|EG000|Reported Event|Cohort 1 (CSL202 With No Busulfan)|Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
11126701|NCT01734850|EG001|Reported Event|Cohort 2 (CSL202 With 1 Busulfan Dose)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11126702|NCT01734850|EG002|Reported Event|Cohort 3 (CSL202 With 2 Busulfan Doses)|"Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant~Busulfan: Intravenous busulfan"
11126703|NCT01734889|BG000|Baseline|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
11126704|NCT01734889|FG000|Participant Flow|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
11126705|NCT01734889|OG000|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
11126706|NCT01734889|OG000|Outcome|Age <5 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
11126707|NCT01734889|EG000|Reported Event|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
11112285|NCT01656850|BG000|Baseline|Almond Diet First, Then NCEP Diet|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
11112286|NCT01656850|BG001|Baseline|NCEP Diet First, Then Almond Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
11112287|NCT01656850|BG002|Baseline|Total|Total of all reporting groups
11112288|NCT01656850|FG000|Participant Flow|Whole Almonds First, Then NCEP Diet|run in 2 weeks, whole almonds diet Intervention (3 months), Washout (2 weeks), and then NCEP diet Intervention (3 months)
11112289|NCT01656850|FG001|Participant Flow|NCEP Diet First, Then Whole Almonds Diet|run in 2 weeks, NCEP diet Intervention (3 months), Washout (2 weeks), whole almonds Intervention (3 months)
11112290|NCT01656850|OG000|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
11112291|NCT01656850|OG001|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
11112292|NCT01656850|OG000|Outcome|Con Before|before consuming NCEP step II diet
11112293|NCT01656850|OG001|Outcome|Con After|after consuming NCEP step II diet for 3 months
11112294|NCT01656850|OG002|Outcome|Alm Before|before consuming almond diet
11112295|NCT01656850|OG003|Outcome|Alm After|after consuming almond diet for 3 months
11112296|NCT01656850|EG000|Reported Event|Whole Almond Diet|participants received experiment diet containing 20% calorie from whole almond
11112297|NCT01656850|EG001|Reported Event|NCEP Diet|participants received NCEP diet for 3 months
11112298|NCT01656889|BG000|Baseline|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
10846048|NCT00272779|BG000|Baseline|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
11112299|NCT01656889|BG001|Baseline|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
11112300|NCT01656889|BG002|Baseline|Total|Total of all reporting groups
11112301|NCT01656889|FG000|Participant Flow|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
11112302|NCT01656889|FG001|Participant Flow|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
11112303|NCT01656889|OG000|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
11112304|NCT01656889|OG001|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
11112305|NCT01656889|EG000|Reported Event|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
11112306|NCT01656889|EG001|Reported Event|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
11112307|NCT01656967|BG000|Baseline|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
11112308|NCT01656967|BG001|Baseline|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
11112309|NCT01656967|BG002|Baseline|Total|Total of all reporting groups
11112310|NCT01656967|FG000|Participant Flow|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
11112311|NCT01656967|FG001|Participant Flow|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
11112312|NCT01656967|OG000|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
11112313|NCT01656967|OG001|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
11112314|NCT01656967|OG000|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera~first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
11112315|NCT01656967|OG001|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use~first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
11112316|NCT01656967|OG000|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, the patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I/aScope 2: Once ventilation is achieved, the patients in group A will be intubated through the shaft of Aura-I via the the Ambu aScope."
11112317|NCT01656967|OG001|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use: The patients in group B will be intubated by ETT via the Intubating LMA as is standard procedure."
11112318|NCT01656967|EG000|Reported Event|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
11112319|NCT01656967|EG001|Reported Event|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
11112320|NCT01657019|BG000|Baseline|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
11112321|NCT01657019|FG000|Participant Flow|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
11112322|NCT01657019|OG000|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
11112323|NCT01657019|EG000|Reported Event|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
11112324|NCT01657032|BG000|Baseline|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
11112325|NCT01657032|BG001|Baseline|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
11112326|NCT01657032|BG002|Baseline|Total|Total of all reporting groups
11112327|NCT01657032|FG000|Participant Flow|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
11112328|NCT01657032|FG001|Participant Flow|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
11112329|NCT01657032|OG000|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
11112330|NCT01657032|OG001|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
11112331|NCT01657032|EG000|Reported Event|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
11126708|NCT01734902|BG000|Baseline|Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)|Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
11112332|NCT01657032|EG001|Reported Event|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
11112333|NCT01657162|BG000|Baseline|Abaloparatide-SC/Alendronate|Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 mcg SC daily for 18 months.
11112334|NCT01657162|BG001|Baseline|Placebo/Alendronate|Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months.
11112335|NCT01657162|BG002|Baseline|Total|Total of all reporting groups
11112336|NCT01657162|FG000|Participant Flow|Abaloparatide-SC/Alendronate|Participants received 70 milligrams (mg) of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 micrograms (mcg) subcutaneous (SC) daily for 18 months.
11112337|NCT01657162|FG001|Participant Flow|Placebo/Alendronate|Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months.
11112338|NCT01657162|OG000|Outcome|Abaloparatide-SC/Alendronate|Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 mcg SC daily for 18 months.
11112339|NCT01657162|OG001|Outcome|Placebo/Alendronate|Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months.
11112340|NCT01657162|EG000|Reported Event|Abaloparatide-SC/Alendronate|Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 mcg SC daily for 18 months.
11112341|NCT01657162|EG001|Reported Event|Placebo/Alendronate|Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months.
11112342|NCT01657253|BG000|Baseline|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
11112343|NCT01657253|BG001|Baseline|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
11112344|NCT01657253|BG002|Baseline|Total|Total of all reporting groups
11112345|NCT01657253|FG000|Participant Flow|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
11112346|NCT01657253|FG001|Participant Flow|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
11112347|NCT01657253|OG000|Outcome|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
11112348|NCT01657253|OG001|Outcome|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
11112349|NCT01657253|EG000|Reported Event|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
11112350|NCT01657253|EG001|Reported Event|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
11112351|NCT01657266|BG000|Baseline|PRO-155|"Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution~Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye~Maintenance therapy: 1 drop 3 times a day for 30 days~PRO-155: Pre-medication (before surgery) and maintenance treatment."
11112352|NCT01657266|BG001|Baseline|Nevanac|"Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension~Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye~Maintenance therapy: 1 drop 3 times a day for 30 days~Nevanac: Pre-medication (before surgery) and maintenance treatment."
10878618|NCT00453362|OG000|Outcome|Overall Study Participants|"All Participants who underwent any FLT-PET scan during the study (including screening) were included in the analysis.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
11112353|NCT01657266|BG002|Baseline|Total|Total of all reporting groups
11112354|NCT01657266|FG000|Participant Flow|PRO-155|"Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution~Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye~Maintenance therapy: 1 drop 3 times a day for 30 days~PRO-155: Pre-medication (before surgery) and maintenance treatment."
11112355|NCT01657266|FG001|Participant Flow|Nevanac|"Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension~Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye~Maintenance therapy: 1 drop 3 times a day for 30 days~Nevanac: Pre-medication (before surgery) and maintenance treatment."
11112356|NCT01657266|OG000|Outcome|PRO-155|"Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution~Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye~Maintenance therapy: 1 drop 3 times a day for 30 days~PRO-155: Pre-medication (before surgery) and maintenance treatment."
11112357|NCT01657266|OG001|Outcome|Nevanac|"Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension~Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye~Maintenance therapy: 1 drop 3 times a day for 30 days~Nevanac: Pre-medication (before surgery) and maintenance treatment."
11112358|NCT01657266|EG000|Reported Event|PRO-155|"Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution~Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye~Maintenance therapy: 1 drop 3 times a day for 30 days~PRO-155: Pre-medication (before surgery) and maintenance treatment."
11112359|NCT01657266|EG001|Reported Event|Nevanac|"Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension~Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye~Maintenance therapy: 1 drop 3 times a day for 30 days~Nevanac: Pre-medication (before surgery) and maintenance treatment."
11112360|NCT01657292|BG000|Baseline|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
11112361|NCT01657292|FG000|Participant Flow|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
11112362|NCT01657292|OG000|Outcome|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
11112363|NCT01657292|EG000|Reported Event|Entire Study Population - Systemic AEs|All patients treated with Oleogel-S10 and Octenilin® wound gel. Systemic AEs which are not localized to the wound application site are reported under this arm.
11112364|NCT01657292|EG001|Reported Event|Oleogel-S10 Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Oleogel-S10 wound half are reported under this arm.
11112365|NCT01657292|EG002|Reported Event|Octenilin Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Octenilin® wound half are reported under this arm.
11112366|NCT01657292|EG003|Reported Event|Localized AE Both Wound Halves|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred at both the Octenilin® wound half and Oleogel-S10 wound half in one patient are reported under this arm.
11112367|NCT01657305|BG000|Baseline|Entire Study Population|Intra-individual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing only. Non-adhesive wound dressings, specifically soft silicone faced polyurethane foam dressings (e.g., Mepilex®), represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of 1 mm (0.04 inches) and wound dressings were changed at least every 3 to 4 days. Study treatment continued until both wound halves were closed (at least 95% epithelialised) or ended at Day 28.
11112368|NCT01657305|FG000|Participant Flow|Entire Study Population|Intraindividual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One wound half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing (intra-individual comparison). Non-adhesive wound dressings such as soft silicone-faced polyurethane foam dressings (e.g., Mepilex®) represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of approximately 1 mm or 0.04 inches. Treatment was repeated and wound dressings were changed at least every 3 to 4 days until wound closure (at least 95% epithelialisation) was achieved or the end of treatment was reached at Day 28.
11112369|NCT01657305|OG000|Outcome|Entire Study Population|All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
11112370|NCT01657305|OG000|Outcome|Oleogel-S10, Non-adhesive Wound Dressing|"A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Oleogel-S10, non-adhesive wound dressing: 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
11112371|NCT01657305|OG001|Outcome|Non-adhesive Wound Dressing Only|"A STSG donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound Dressings are Standard of care (SOC) in the Treatment of STSG donor sites. Wound Dressings were changed every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Non-adhesive wound dressing only: Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
11112372|NCT01657305|OG000|Outcome|Investigator Asssessment Day 7|Efficacy as assessed by investigator at Day 7
11112373|NCT01657305|OG001|Outcome|Investigator Assessment Day 14|Efficacy as assessed by investigator at Day 14
11112374|NCT01657305|OG002|Outcome|Investigator Assessment Day 21|Efficacy as assessed by investigator at Day 21
11112375|NCT01657305|OG003|Outcome|Investigator Assessment Day 28|Efficacy as assessed by investigator at Day 28
11112376|NCT01657305|OG004|Outcome|Investigator Assessment End of Treatment|Efficacy as assessed by investigator at End of Treatment (EoT)
11112377|NCT01657305|OG005|Outcome|Participant Assessment Day 7|Efficacy as assessed by participant at Day 7
11112378|NCT01657305|OG006|Outcome|Participant Assessment Day 14|Efficacy as assessed by participant at Day 14
11112379|NCT01657305|OG007|Outcome|Participant Assessment Day 21|Efficacy as assessed by participant at Day 21
11112380|NCT01657305|OG008|Outcome|Participant Assessment Day 28|Efficacy as assessed by participant at Day 28
11112381|NCT01657305|OG009|Outcome|Participant Assessment EoT|Efficacy as assessed by participant at EoT
11112382|NCT01657305|OG000|Outcome|Texture at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to texture at 3 months follow-up
11112383|NCT01657305|OG001|Outcome|Hair Growth at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to hair growth at 3 months follow-up
11112384|NCT01657305|OG002|Outcome|Pigmentation at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to pigmentation at 3 months follow-up
11112385|NCT01657305|OG003|Outcome|Redness at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to redness at 3 months follow-up
11112386|NCT01657305|OG004|Outcome|Texture at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to texture at 12 months follow-up
11112387|NCT01657305|OG005|Outcome|Hair Growth at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to hair growth at 12 months follow-up
11112388|NCT01657305|OG006|Outcome|Pigmentation at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to pigmentation at 12 months follow-up
11112389|NCT01657305|OG007|Outcome|Redness at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to redness at 12 months follow-up
11112390|NCT01657305|OG000|Outcome|Investigator Asssessment Day 7|Tolerability as assessed by investigator at Day 7
11112391|NCT01657305|OG001|Outcome|Investigator Assessment Day 14|Tolerability as assessed by investigator at Day 14
11112392|NCT01657305|OG002|Outcome|Investigator Assessment Day 21|Tolerability as assessed by investigator at Day 21
11112393|NCT01657305|OG003|Outcome|Investigator Assessment Day 28|Tolerability as assessed by investigator at Day 28
11112394|NCT01657305|OG004|Outcome|Investigator Assessment End of Treatment|Tolerability as assessed by investigator at End of Treatment (EoT)
11112395|NCT01657305|OG005|Outcome|Participant Assessment Day 7|Tolerability as assessed by participant at Day 7
11112396|NCT01657305|OG006|Outcome|Participant Assessment Day 14|Tolerability as assessed by participant at Day 14
11112397|NCT01657305|OG007|Outcome|Participant Assessment Day 21|Tolerability as assessed by participant at Day 21
11112398|NCT01657305|OG008|Outcome|Participant Assessment Day 28|Tolerability as assessed by participant at Day 28
11112399|NCT01657305|OG009|Outcome|Participant Assessment EoT|Tolerability as assessed by participant at EoT
11112400|NCT01657305|OG000|Outcome|Day 0 (Pre-dose)|Plasma samples collected at the day of STSG surgery prior to first treatment with study medication
11112401|NCT01657305|OG001|Outcome|Treatment Period|Plasma samples collected at Day 7, Day 14, Day 21 or at end of treatment (day of wound closure or Day 28)
11112402|NCT01657305|OG000|Outcome|Entire Study Population|All participants who were randomized and treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only.
11112403|NCT01657305|EG000|Reported Event|Entire Study Population - Systemic Adverse Events (AE)|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. AEs not localized to any wound application site by the investigator are reported in this arm.
11112404|NCT01657305|EG001|Reported Event|Oleogel-S10 Localized AE|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the Oleogel-S10 wound half are reported in this arm.
11112405|NCT01657305|EG002|Reported Event|Non-adhesive Wound Wound Dressing Localized AE|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the wound half treated only with non-adhesive wound dressing are reported in this arm.
11112406|NCT01657305|EG003|Reported Event|Localized AE Both Wound Halves|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred at both the Oleogel-S10 wound half and the non-adhesive wound dressing only half in one patient are reported in this arm.
11112407|NCT01657344|BG000|Baseline|Patients Visits to the Emergency Department|There are no arms for this study. We are collecting all electronic patient data for all patients that present to the Emergency Department. Quality performance measures are constructed directly from the data in the registry.
11112408|NCT01657344|FG000|Participant Flow|CHOP Base Emergency Department (ED) Patients|All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021.
11112409|NCT01657344|FG001|Participant Flow|Cincinnati Children's Hospital Medical Center (CCHMC) Base ED|All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021.
11112410|NCT01657344|FG002|Participant Flow|CCHMC Satellite ED|All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021.
11112411|NCT01657344|FG003|Participant Flow|Children's National Medical Center (CNMC) Base ED|All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021.
11112412|NCT01657344|FG004|Participant Flow|CNMC Satellite ED|All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021.
11112413|NCT01657344|FG005|Participant Flow|The Children's Hospital Colorado Base ED|All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021.
11112414|NCT01657344|FG006|Participant Flow|The Children's Hospital Colorado Satellite ED|All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021.
11112415|NCT01657344|OG000|Outcome|CHOP Base Emergency Department (ED)|All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED.
11112416|NCT01657344|OG001|Outcome|Cincinnati Children's Hospital Medical Center (CCHMC) Base ED|All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED.
10846049|NCT00272779|BG001|Baseline|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
10846050|NCT00272779|BG002|Baseline|Total|Total of all reporting groups
11112417|NCT01657344|OG002|Outcome|CCHMC Satellite ED|All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED.
11112418|NCT01657344|OG003|Outcome|Children's National Medical Center (CNMC) Base ED|All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED.
11112419|NCT01657344|OG004|Outcome|CNMC Satellite ED|All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED.
11112420|NCT01657344|OG005|Outcome|The Children's Hospital Colorado Base ED|All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED.
11112421|NCT01657344|OG006|Outcome|The Children's Hospital Colorado Satellite ED|All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED.
11112422|NCT01657344|EG000|Reported Event|ED Patients|All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED.
11112423|NCT01657370|BG000|Baseline|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112424|NCT01657370|BG001|Baseline|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112425|NCT01657370|BG002|Baseline|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112426|NCT01657370|BG003|Baseline|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112427|NCT01657370|BG004|Baseline|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112428|NCT01657370|BG005|Baseline|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112429|NCT01657370|BG006|Baseline|Total|Total of all reporting groups
11112430|NCT01657370|FG000|Participant Flow|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112431|NCT01657370|FG001|Participant Flow|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112432|NCT01657370|FG002|Participant Flow|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112433|NCT01657370|FG003|Participant Flow|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112434|NCT01657370|FG004|Participant Flow|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112435|NCT01657370|FG005|Participant Flow|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112436|NCT01657370|OG000|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112437|NCT01657370|OG001|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112438|NCT01657370|OG002|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112439|NCT01657370|OG003|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112440|NCT01657370|OG004|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112441|NCT01657370|OG000|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112442|NCT01657370|OG001|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112443|NCT01657370|OG002|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112444|NCT01657370|OG003|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112445|NCT01657370|OG004|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112446|NCT01657370|OG005|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112447|NCT01657370|EG000|Reported Event|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112448|NCT01657370|EG001|Reported Event|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112449|NCT01657370|EG002|Reported Event|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112450|NCT01657370|EG003|Reported Event|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112451|NCT01657370|EG004|Reported Event|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112452|NCT01657370|EG005|Reported Event|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
11112453|NCT01657461|BG000|Baseline|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
11112454|NCT01657461|BG001|Baseline|IV t-PA|IV infusion of tPA
11112455|NCT01657461|BG002|Baseline|Total|Total of all reporting groups
11112456|NCT01657461|FG000|Participant Flow|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
11112457|NCT01657461|FG001|Participant Flow|IV t-PA|IV infusion of tPA
11112458|NCT01657461|OG000|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
11112459|NCT01657461|OG001|Outcome|IV t-PA|IV infusion of tPA
11112460|NCT01657461|EG000|Reported Event|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
11112461|NCT01657461|EG001|Reported Event|IV t-PA|IV infusion of tPA
11112462|NCT01657617|BG000|Baseline|Radiation Therapy|"Boost Stereotactic Body Radiation Therapy~Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:~Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.~Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy."
11112463|NCT01657617|FG000|Participant Flow|Radiation Therapy|"Boost Stereotactic Body Radiation Therapy~Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:~Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.~Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy."
11112464|NCT01657617|OG000|Outcome|Radiation Therapy|"Boost Stereotactic Body Radiation Therapy~Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:~Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.~Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy."
11112465|NCT01657617|EG000|Reported Event|Radiation Therapy|"Boost Stereotactic Body Radiation Therapy~Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:~Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.~Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy."
11112466|NCT01657760|BG000|Baseline|Alcohol Dependent|DSM-IV alcohol dependent
11112467|NCT01657760|BG001|Baseline|Healthy Control|participants with no Axis I illness or substance use disorder
11112468|NCT01657760|BG002|Baseline|Total|Total of all reporting groups
11126709|NCT01734902|BG001|Baseline|Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)|Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
11126710|NCT01734902|BG002|Baseline|Total|Total of all reporting groups
11112469|NCT01657760|FG000|Participant Flow|Alcohol Dependent Citalopram First Placebo Second|"DSM-IV alcohol dependent participants.~Qualifying participants were invited back for three subsequent visits: a structural MRI scan, and two study medication/[18F]-fallypride PET scanning days (citalopram 40 mg iv, or saline placebo, double-blinded, administered in counter-balancing order) more than 1 week apart. All completing participants had breathalyzer-confirmed exhaled alcohol concentration of 0, and low alcohol withdrawal scores (confirming no intoxication and minimal alcohol withdrawal symptoms) on all study visits (see below). On study medication/PET scanning days, the following procedures were completed in order: 1. Breathalyzer, withdrawal, and psychiatric symptomatology screening; 2. Intravenous citalopram (or saline placebo) infusion (1 h). 3. Cue-induced craving assessment (~20 minutes). 4. [18F]-fallypride PET scanning (~3 h)."
11112470|NCT01657760|FG001|Participant Flow|Alcohol Dependent Placebo First Citalopram Second|"DSM-IV alcohol dependent participants.~Qualifying participants were invited back for three subsequent visits: a structural MRI scan, and two study medication/[18F]-fallypride PET scanning days (citalopram 40 mg iv, or saline placebo, double-blinded, administered in counter-balancing order) more than 1 week apart. All completing participants had breathalyzer-confirmed exhaled alcohol concentration of 0, and low alcohol withdrawal scores (confirming no intoxication and minimal alcohol withdrawal symptoms) on all study visits (see below). On study medication/PET scanning days, the following procedures were completed in order: 1. Breathalyzer, withdrawal, and psychiatric symptomatology screening; 2. Intravenous citalopram (or saline placebo) infusion (1 h). 3. Cue-induced craving assessment (~20 minutes). 4. [18F]-fallypride PET scanning (~3 h)."
11112471|NCT01657760|FG002|Participant Flow|Healthy Control Citalopram First Placebo Second|"participants with no Axis I mental illness or substance use disorder.~Same procedures as AD group"
11112472|NCT01657760|FG003|Participant Flow|Healthy Control Placebo First Citalopram Second|"participants with no Axis I mental illness or substance use disorder.~Same procedures as AD group"
11112473|NCT01657760|OG000|Outcome|Alcohol Dependent Citalopram Infusion|"40 mg citalopram in 250 ml saline infused over 1 hour, in a double-blind, crossover study, with infusion days at least 2 weeks apart.~citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design."
11112474|NCT01657760|OG001|Outcome|Alcohol Dependent Placebo|"Intravenous saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart.~citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design."
11112475|NCT01657760|OG002|Outcome|Healthy Control Citalopram Infusion|"40 mg citalopram in 250 ml saline infused over 1 hour, in a double-blind, crossover study, with infusion days at least 2 weeks apart.~citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design."
11112476|NCT01657760|OG003|Outcome|Healthy Control Placebo Infusion|"Intravenous saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart.~citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design."
11112477|NCT01657760|OG000|Outcome|Alcohol Dependent Citalopram Infusion|DSM-IV alcohol dependent
11112478|NCT01657760|OG001|Outcome|Healthy Control Citalopram Infusion|participants with no Axis I illness or substance use disorder
11112479|NCT01657760|OG002|Outcome|Alcohol Dependent Placebo Infusion|DSM-IV alcohol dependent
11112480|NCT01657760|OG003|Outcome|Healthy Control Placebo Infusion|participants with no Axis I illness or substance use disorder
11112481|NCT01657760|EG000|Reported Event|Placebo|"Intravenous saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart.~citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design."
11112482|NCT01657760|EG001|Reported Event|Citalopram Infusion|"40 mg citalopram in 250 ml saline infused over 1 hour, in a double-blind, crossover study, with infusion days at least 2 weeks apart.~citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design."
11112483|NCT01657799|BG000|Baseline|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112484|NCT01657799|BG001|Baseline|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112485|NCT01657799|BG002|Baseline|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112486|NCT01657799|BG003|Baseline|Total|Total of all reporting groups
11112487|NCT01657799|FG000|Participant Flow|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112488|NCT01657799|FG001|Participant Flow|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112489|NCT01657799|FG002|Participant Flow|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112490|NCT01657799|OG000|Outcome|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112491|NCT01657799|OG001|Outcome|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112492|NCT01657799|OG002|Outcome|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112493|NCT01657799|EG000|Reported Event|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112494|NCT01657799|EG001|Reported Event|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112495|NCT01657799|EG002|Reported Event|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
11112496|NCT01657877|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics.
11112497|NCT01657877|FG000|Participant Flow|Overall Participants|"In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:~Dentifrice containing 1500 parts per million (ppm) as sodium monofluorophosphate (SMFP) + 5% calcium sodium phosphosilicate (CSP)~Dentifrice containing 1500 ppm fluoride as SMFP + 0% CSP~Dentifrice containing 500 ppm fluoride as SMFP + 0% CSP~Dentifrice containing 0 ppm fluoride + 0% CSP~Dentifrice containing 0 ppm fluoride + 5% CSP. The participants applied the given dentifrice as per their treatment group to a toothbrush and brushed their natural teeth twice daily for one timed minute. There was a washout period of 6 days between each treatment period."
11112498|NCT01657877|OG000|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112499|NCT01657877|OG001|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112500|NCT01657877|OG002|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112501|NCT01657877|OG000|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112502|NCT01657877|OG001|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112503|NCT01657877|OG002|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112504|NCT01657877|OG003|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112505|NCT01657877|OG004|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112506|NCT01657877|OG000|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112507|NCT01657877|OG001|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 5 % CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112508|NCT01657877|EG000|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112509|NCT01657877|EG001|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112510|NCT01657877|EG002|Reported Event|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112511|NCT01657877|EG003|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112512|NCT01657877|EG004|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
11112513|NCT01657903|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
11112514|NCT01657903|FG000|Participant Flow|Overall|This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.
11112515|NCT01657903|OG000|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
11112516|NCT01657903|OG001|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
11112517|NCT01657903|OG002|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
11112518|NCT01657903|OG003|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
11112519|NCT01657903|OG003|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
11112520|NCT01657903|EG000|Reported Event|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 parts per million of fluoride as NaF and 5% w/w KNO3.
11112521|NCT01657903|EG001|Reported Event|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
11112522|NCT01657903|EG002|Reported Event|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
11112523|NCT01657903|EG003|Reported Event|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
11112524|NCT01658020|BG000|Baseline|DW224|Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days
11112525|NCT01658020|BG001|Baseline|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
11112526|NCT01658020|BG002|Baseline|Total|Total of all reporting groups
11112527|NCT01658020|FG000|Participant Flow|DW224|Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily
11112528|NCT01658020|FG001|Participant Flow|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7days
11112529|NCT01658020|OG000|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
11112530|NCT01658020|OG001|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
11112531|NCT01658020|OG001|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily 7 days
11112532|NCT01658020|EG000|Reported Event|DW224|"Zabofloxacin Tablet 400mg given by oral administration~Moxifloxacin Tablet 400mg: multiple-dose"
11112533|NCT01658020|EG001|Reported Event|Avelox|"Moxifloxacin Tablet 400mg given by oral administration~Zabofloxacin Tablet 400mg: multiple-dose"
11112534|NCT01658059|BG000|Baseline|All Study Population|cross over design. Group 1 got homeopathic remedy on the first dental treatment, and placebo on the second treatment. Group 2 got placebo on the first dental treatment, homeopathic remedy on the second treatment
11112535|NCT01658059|FG000|Participant Flow|Homeopathic Remedy First, Then Placebo|Homeopathic Remedy first, washout period and then Placebo
11112536|NCT01658059|FG001|Participant Flow|Placebo First, Then Homeopathic Remedy|Placebo first, washout period and then Homeopathic Remedy
11112537|NCT01658059|OG000|Outcome|Homeopathic Remedy|Group 1 got homeopathic remedy on the first dental treatment . Group 2 got homeopathic remedy on the second treatment.
11112538|NCT01658059|OG001|Outcome|Placebo|Group 2 got placebo on the first dental treatment . Group 1 got placebo on the second treatment.
11112539|NCT01658059|EG000|Reported Event|Homeopathic Remedy|Cross over design. Group 1 got homeopathic remedy on the first dental treatment. Group 2 got homeopathic remedy on the second treatment.
11112540|NCT01658059|EG001|Reported Event|Placebo|Cross over design. Group 1 got placebo on the second dental treatment. Group 2 got placebo on the first treatment.
11112541|NCT01658072|BG000|Baseline|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
11112542|NCT01658072|BG001|Baseline|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
11112543|NCT01658072|BG002|Baseline|Total|Total of all reporting groups
11112544|NCT01658072|FG000|Participant Flow|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
11112545|NCT01658072|FG001|Participant Flow|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
11112546|NCT01658072|OG000|Outcome|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
11112547|NCT01658072|OG001|Outcome|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
11112548|NCT01658072|EG000|Reported Event|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
11112549|NCT01658072|EG001|Reported Event|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
11112550|NCT01658150|BG000|Baseline|Isradipine|Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. Isradipine as utilized in this trial will be administered twice daily. Isradipine will be titrated as follows: baseline (week 0) 5 mg/day BID; Week 2 increase to 10 mg/day BID if 5 mg was well-tolerated. Dosing will be flexible based on side effects with a maximum=10 mg/day. If 5 mg cannot be tolerated, the subject will be discontinued.
11112551|NCT01658150|FG000|Participant Flow|Isradipine|Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. isradipine as utilized in this trial will be administered twice daily. Isradipine will be titrated as follows: baseline (week 0) 5 mg/day BID; Week 2 increase to 10 mg/day BID if 5 mg was well-tolerated. Dosing will be flexible based on side effects with a maximum=10 mg/day. If 5 mg cannot be tolerated, the subject will be discontinued.
11112552|NCT01658150|OG000|Outcome|Isradipine|Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. Isradipine as utilized in this trial will be administered twice daily. Isradipine will be titrated as follows: baseline (week 0) 5 mg/day BID; Week 2 increase to 10 mg/day BID if 5 mg was well-tolerated. Dosing will be flexible based on side effects with a maximum=10 mg/day. If 5 mg cannot be tolerated, the subject will be discontinued.
11112553|NCT01658150|OG000|Outcome|Isradipine|Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. Need dosage information.
11112554|NCT01658150|EG000|Reported Event|Isradipine|Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. isradipine as utilized in this trial will be administered twice daily. Isradipine will be titrated as follows: baseline (week 0) 5 mg/day BID; Week 2 increase to 10 mg/day BID if 5 mg was well-tolerated. Dosing will be flexible based on side effects with a maximum=10 mg/day. If 5 mg cannot be tolerated, the subject will be discontinued.
11112555|NCT01658228|BG000|Baseline|Donepezil Treatment Group|"For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.~Donepezil: Donepezil 5mg will be given for 6 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg per day is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease."
11112556|NCT01658228|BG001|Baseline|Placebo Treatment Group|"For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.~Placebo: A placebo capsule will be given to randomized subjects for the starting at week 16 and continuing for the remainder of the study. This group will not receive donepezil as treatment."
11112557|NCT01658228|BG002|Baseline|Total|Total of all reporting groups
11112558|NCT01658228|FG000|Participant Flow|Donepezil Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.
11112559|NCT01658228|FG001|Participant Flow|Placebo Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.
11112560|NCT01658228|OG000|Outcome|Donepezil Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.
11112561|NCT01658228|OG001|Outcome|Placebo Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.
11112562|NCT01658228|EG000|Reported Event|Donepezil Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.
11112563|NCT01658228|EG001|Reported Event|Placebo Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.
11112564|NCT01658436|BG000|Baseline|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
11112565|NCT01658436|FG000|Participant Flow|BEZ235 300 mg|Oral BEZ235 300 mg bid was investigated in stage 1 of study
11112566|NCT01658436|FG001|Participant Flow|BEZ235 400 mg Bid|Oral BEZ235 400 mg bid was investigated in stage 1 of study
11112567|NCT01658436|OG000|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
11112568|NCT01658436|EG000|Reported Event|BEZ235 300 mg Bid|BEZ235 300 mg bid
11112569|NCT01658436|EG001|Reported Event|BEZ235 400 mg Bid|BEZ235 400 mg bid
11112570|NCT01658514|BG000|Baseline|Normal|Normal Renal Function = eGFR ≥90 mL/min/1.73 m²
11112571|NCT01658514|BG001|Baseline|Mild RI|Mild Renal Impairment = eGFR ≥60 to <90 mL/min/1.73 m²
11112572|NCT01658514|BG002|Baseline|Moderate RI|Moderate Renal Impairment = eGFR ≥30 to <60 mL/min/1.73 m²
11112573|NCT01658514|BG003|Baseline|Severe RI|Severe Renal Impairment = eGFR ≥15 to <30 mL/min/1.73 m²
11112574|NCT01658514|BG004|Baseline|Total|Total of all reporting groups
11112575|NCT01658514|FG000|Participant Flow|Sequence ABC|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
11112576|NCT01658514|FG001|Participant Flow|Sequence CAB|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
11112577|NCT01658514|FG002|Participant Flow|Sequence BCA|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
11112578|NCT01658514|OG000|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
11112579|NCT01658514|OG001|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
11112580|NCT01658514|EG000|Reported Event|Placebo|One dose of Placebo
11112581|NCT01658514|EG001|Reported Event|Met DR|One dose of 1000 mg Metformin Delayed-Release
11112582|NCT01658514|EG002|Reported Event|Met XR|One dose of 1000 mg Metformin Extended-Release
11112583|NCT01658579|BG000|Baseline|HOE901-U300 Morning Then Evening|HOE901-U300 SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
11112584|NCT01658579|BG001|Baseline|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
11112585|NCT01658579|BG002|Baseline|Lantus Morning Then Evening|Lantus SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
11112586|NCT01658579|BG003|Baseline|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
11112587|NCT01658579|BG004|Baseline|Total|Total of all reporting groups
11112588|NCT01658579|FG000|Participant Flow|HOE901-U300 Morning Then Evening|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L) (80-130 milligram per deciliter [mg/dL]).
11112589|NCT01658579|FG001|Participant Flow|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80-130 mg/dL).
11112590|NCT01658579|FG002|Participant Flow|Lantus Morning Then Evening|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80-130 mg/dL).
11112591|NCT01658579|FG003|Participant Flow|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80-130 mg/dL).
11112592|NCT01658579|OG000|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
11112593|NCT01658579|OG001|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
11112594|NCT01658579|EG000|Reported Event|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
11112595|NCT01658579|EG001|Reported Event|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
11112596|NCT01658657|BG000|Baseline|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
11112597|NCT01658657|BG001|Baseline|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
11112598|NCT01658657|BG002|Baseline|Total|Total of all reporting groups
11112599|NCT01658657|FG000|Participant Flow|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
11112600|NCT01658657|FG001|Participant Flow|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
11112601|NCT01658657|OG000|Outcome|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
11112602|NCT01658657|OG001|Outcome|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
11112603|NCT01658657|EG000|Reported Event|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
11112604|NCT01658657|EG001|Reported Event|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
11112605|NCT01658735|BG000|Baseline|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
11112606|NCT01658735|BG001|Baseline|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
11112607|NCT01658735|BG002|Baseline|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
11112608|NCT01658735|BG003|Baseline|Total|Total of all reporting groups
11112609|NCT01658735|FG000|Participant Flow|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
11112610|NCT01658735|FG001|Participant Flow|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
11112611|NCT01658735|FG002|Participant Flow|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
11112612|NCT01658735|OG000|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
11112613|NCT01658735|OG001|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
11112614|NCT01658735|OG002|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
11112615|NCT01658735|EG000|Reported Event|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
11112616|NCT01658735|EG001|Reported Event|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
11112617|NCT01658735|EG002|Reported Event|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
11112618|NCT01658839|BG000|Baseline|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
11112619|NCT01658839|FG000|Participant Flow|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
11112620|NCT01658839|OG000|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
11112621|NCT01658839|EG000|Reported Event|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
11112622|NCT01658904|BG000|Baseline|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112623|NCT01658904|BG001|Baseline|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112624|NCT01658904|BG002|Baseline|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112625|NCT01658904|BG003|Baseline|Total|Total of all reporting groups
11112626|NCT01658904|FG000|Participant Flow|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112627|NCT01658904|FG001|Participant Flow|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112628|NCT01658904|FG002|Participant Flow|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112629|NCT01658904|OG000|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112630|NCT01658904|OG001|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112631|NCT01658904|OG002|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112632|NCT01658904|OG000|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
11112633|NCT01658904|OG001|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
11112634|NCT01658904|OG002|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
11112635|NCT01658904|EG000|Reported Event|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112636|NCT01658904|EG001|Reported Event|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112637|NCT01658904|EG002|Reported Event|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
11112638|NCT01658943|BG000|Baseline|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11112639|NCT01658943|BG001|Baseline|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11112640|NCT01658943|BG002|Baseline|Total|Total of all reporting groups
11112641|NCT01658943|FG000|Participant Flow|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11112642|NCT01658943|FG001|Participant Flow|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11112643|NCT01658943|OG000|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11112644|NCT01658943|OG001|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11112645|NCT01658943|EG000|Reported Event|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11112646|NCT01658943|EG001|Reported Event|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11112647|NCT01658995|BG000|Baseline|Post ESI Implant - Doxycycline|Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
11112648|NCT01658995|BG001|Baseline|Post ESI Implant - Placebo|Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
11112649|NCT01658995|BG002|Baseline|Total|Total of all reporting groups
11112650|NCT01658995|FG000|Participant Flow|Post ESI Implant - Doxycycline|Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
11112651|NCT01658995|FG001|Participant Flow|Post ESI Implant - Placebo|Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
11112652|NCT01658995|OG000|Outcome|Post ESI Implant - Doxycycline|Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
11112653|NCT01658995|OG001|Outcome|Post ESI Implant - Placebo|Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
11112654|NCT01658995|EG000|Reported Event|Post ESI Implant - Doxycycline|Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
11112655|NCT01658995|EG001|Reported Event|Post ESI Implant - Placebo|Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
11112656|NCT01659021|BG000|Baseline|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
11112657|NCT01659021|BG001|Baseline|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
11112658|NCT01659021|BG002|Baseline|Total|Total of all reporting groups
11112659|NCT01659021|FG000|Participant Flow|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone."
11112660|NCT01659021|FG001|Participant Flow|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone."
11112661|NCT01659021|OG000|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
11112662|NCT01659021|OG001|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
11112663|NCT01659021|OG000|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone."
11112664|NCT01659021|OG001|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone."
11112665|NCT01659021|OG000|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Participants in this group had 17p deletion and/or TP53 mutation."
11112666|NCT01659021|OG001|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Participants in this group had 17p deletion and/or TP53 mutation."
11112667|NCT01659021|EG000|Reported Event|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone."
11112668|NCT01659021|EG001|Reported Event|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone."
11112669|NCT01659125|BG000|Baseline|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
11112670|NCT01659125|FG000|Participant Flow|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
11112671|NCT01659125|OG000|Outcome|OCFighter Participants|Participants who initiated treatment
11112672|NCT01659125|EG000|Reported Event|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
11112673|NCT01659255|BG000|Baseline|Tirabrutinib 20 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 20 mg once daily.
11112674|NCT01659255|BG001|Baseline|Tirabrutinib 40 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
11112675|NCT01659255|BG002|Baseline|Tirabrutinib 80 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
11112676|NCT01659255|BG003|Baseline|Tirabrutinib 160 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
11112677|NCT01659255|BG004|Baseline|Tirabrutinib 320 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
11112678|NCT01659255|BG005|Baseline|Tirabrutinib 400 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
11112679|NCT01659255|BG006|Baseline|Tirabrutinib 500 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
11112680|NCT01659255|BG007|Baseline|Tirabrutinib 600 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
11112681|NCT01659255|BG008|Baseline|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
11112682|NCT01659255|BG009|Baseline|Tirabrutinib 20 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 20 mg once daily.
11112683|NCT01659255|BG010|Baseline|Tirabrutinib 40 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
11112684|NCT01659255|BG011|Baseline|Tirabrutinib 80 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
11112685|NCT01659255|BG012|Baseline|Tirabrutinib 160 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
11112686|NCT01659255|BG013|Baseline|Tirabrutinib 320 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
11112687|NCT01659255|BG014|Baseline|Tirabrutinib 480 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
11112688|NCT01659255|BG015|Baseline|Tirabrutinib 600 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
11112689|NCT01659255|BG016|Baseline|Tirabrutinib 240 mg Twice Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
11112690|NCT01659255|BG017|Baseline|Total|Total of all reporting groups
11112691|NCT01659255|FG000|Participant Flow|Tirabrutinib 20 mg Once Daily (CLL)|Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily.
11112692|NCT01659255|FG001|Participant Flow|Tirabrutinib 40 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
11112693|NCT01659255|FG002|Participant Flow|Tirabrutinib 80 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
11112694|NCT01659255|FG003|Participant Flow|Tirabrutinib 160 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
11112695|NCT01659255|FG004|Participant Flow|Tirabrutinib 320 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
11112696|NCT01659255|FG005|Participant Flow|Tirabrutinib 400 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
11112697|NCT01659255|FG006|Participant Flow|Tirabrutinib 500 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
11112698|NCT01659255|FG007|Participant Flow|Tirabrutinib 600 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
11112699|NCT01659255|FG008|Participant Flow|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
11112700|NCT01659255|FG009|Participant Flow|Tirabrutinib 20 mg Once Daily (NHL)|Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily.
11112701|NCT01659255|FG010|Participant Flow|Tirabrutinib 40 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
11112702|NCT01659255|FG011|Participant Flow|Tirabrutinib 80 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
11112703|NCT01659255|FG012|Participant Flow|Tirabrutinib 160 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
11112704|NCT01659255|FG013|Participant Flow|Tirabrutinib 320 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
11112705|NCT01659255|FG014|Participant Flow|Tirabrutinib 480 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
11112706|NCT01659255|FG015|Participant Flow|Tirabrutinib 600 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
11112707|NCT01659255|FG016|Participant Flow|Tirabrutinib 240 mg Twice Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
11112708|NCT01659255|OG000|Outcome|Tirabrutinib 20 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 20 mg once daily.
11112709|NCT01659255|OG001|Outcome|Tirabrutinib 40 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
11112710|NCT01659255|OG002|Outcome|Tirabrutinib 80 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
11112711|NCT01659255|OG003|Outcome|Tirabrutinib 160 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
11112712|NCT01659255|OG004|Outcome|Tirabrutinib 320 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
11112713|NCT01659255|OG005|Outcome|Tirabrutinib 400 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
11112714|NCT01659255|OG006|Outcome|Tirabrutinib 500 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
11112715|NCT01659255|OG007|Outcome|Tirabrutinib 600 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
11112716|NCT01659255|OG008|Outcome|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
11112717|NCT01659255|OG009|Outcome|Tirabrutinib 20 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 20 mg once daily.
11112718|NCT01659255|OG010|Outcome|Tirabrutinib 40 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
11112719|NCT01659255|OG011|Outcome|Tirabrutinib 80 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
11112720|NCT01659255|OG012|Outcome|Tirabrutinib 160 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
11112721|NCT01659255|OG013|Outcome|Tirabrutinib 320 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
11112722|NCT01659255|OG014|Outcome|Tirabrutinib 480 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
11112723|NCT01659255|OG015|Outcome|Tirabrutinib 600 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
11112724|NCT01659255|OG016|Outcome|Tirabrutinib 240 mg Twice Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
11112725|NCT01659255|OG000|Outcome|Chronic Lymphocytic Leukaemia|Participants with relapsed/refractory CLL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112726|NCT01659255|OG001|Outcome|NHL Subtype FL|Participants with NHL subtype follicular lymphoma (FL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112727|NCT01659255|OG002|Outcome|NHL Subtype SLL|Participants with NHL subtype small lymphocytic lymphoma (SLL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112728|NCT01659255|OG003|Outcome|NHL Subtype WM|Participants with NHL subtype Waldenstrom macroglobulinemia (WM) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112729|NCT01659255|OG004|Outcome|NHL Subtype MZL|Participants with NHL subtype marginal zone lymphoma (MZL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112730|NCT01659255|OG005|Outcome|NHL Subtype DLBCL|Participants with NHL subtype diffuse large B-cell lymphoma (DLBCL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112731|NCT01659255|OG006|Outcome|NHL Subtype MCL|Participants with NHL subtype mantle cell lymphoma (MCL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112732|NCT01659255|OG000|Outcome|Tirabrutinib 20 mg Once Daily (CLL or NHL)|Participants with relapsed/refractory CLL or NHL received tirabrutinib 20 mg once daily.
11112733|NCT01659255|OG001|Outcome|Tirabrutinib 40 mg Once Daily (CLL or NHL)|Participants with relapsed/refractory CLL or NHL received tirabrutinib 40 mg once daily.
11112734|NCT01659255|OG002|Outcome|Tirabrutinib 80 mg Once Daily (CLL or NHL)|Participants with relapsed/refractory CLL or NHL received tirabrutinib 80 mg once daily.
11112735|NCT01659255|OG003|Outcome|Tirabrutinib 160 mg Once Daily (CLL or NHL)|Participants with relapsed/refractory CLL or NHL received tirabrutinib 160 mg once daily.
11112736|NCT01659255|OG004|Outcome|Tirabrutinib 320 mg Once Daily (CLL or NHL)|Participants with relapsed/refractory CLL or NHL received tirabrutinib 320 mg once daily.
11112737|NCT01659255|OG006|Outcome|Tirabrutinib 480 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
11112738|NCT01659255|OG007|Outcome|Tirabrutinib 500 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
11112739|NCT01659255|OG008|Outcome|Tirabrutinib 600 mg Once Daily (CLL or NHL)|Participants with relapsed/refractory CLL or NHL received tirabrutinib 600 mg once daily.
11112740|NCT01659255|OG009|Outcome|Tirabrutinib 240 mg Twice Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
11112741|NCT01659255|OG010|Outcome|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
11112742|NCT01659255|EG000|Reported Event|Chronic Lymphocytic Leukaemia|Participants with relapsed/refractory CLL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112743|NCT01659255|EG001|Reported Event|Non-Hodgkin's Lymphoma|Participants with relapsed/refractory NHL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
11112744|NCT01659268|BG000|Baseline|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
11112745|NCT01659268|BG001|Baseline|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
11112746|NCT01659268|BG002|Baseline|Total|Total of all reporting groups
11112747|NCT01659268|FG000|Participant Flow|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
11112748|NCT01659268|FG001|Participant Flow|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
11112749|NCT01659268|OG000|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
11112750|NCT01659268|OG001|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
11112751|NCT01659268|EG000|Reported Event|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
11112752|NCT01659268|EG001|Reported Event|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
11112753|NCT01659320|BG000|Baseline|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
11112754|NCT01659320|FG000|Participant Flow|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
11112755|NCT01659320|OG000|Outcome|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
11112756|NCT01659320|EG000|Reported Event|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
11112757|NCT01659567|BG000|Baseline|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
11112758|NCT01659567|FG000|Participant Flow|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
11112759|NCT01659567|OG000|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
11112760|NCT01659567|EG000|Reported Event|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
11112761|NCT01659736|BG000|Baseline|TMS Therapy|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112762|NCT01659736|BG001|Baseline|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112763|NCT01659736|BG002|Baseline|Total|Total of all reporting groups
11112764|NCT01659736|FG000|Participant Flow|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112765|NCT01659736|FG001|Participant Flow|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112766|NCT01659736|OG000|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112767|NCT01659736|OG001|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112768|NCT01659736|OG000|Outcome|TMS- Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112769|NCT01659736|OG001|Outcome|TMS- Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112770|NCT01659736|EG000|Reported Event|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112771|NCT01659736|EG001|Reported Event|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
11112772|NCT01659853|BG000|Baseline|Overall Study|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
11112773|NCT01659853|FG000|Participant Flow|CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15%|"Subjects were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
11112774|NCT01659853|FG001|Participant Flow|Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle|"Subjects were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
11112775|NCT01659853|OG000|Outcome|CD07805/47 Gel 0.5% and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
11112776|NCT01659853|OG001|Outcome|Azelaic Acid Gel 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
11112777|NCT01659853|OG000|Outcome|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
11112778|NCT01659853|OG001|Outcome|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
11112779|NCT01659853|EG000|Reported Event|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
11112780|NCT01659853|EG001|Reported Event|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
11112781|NCT01659866|BG000|Baseline|Cipro-susceptible|"Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy~Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy"
11112782|NCT01659866|BG001|Baseline|Cipro-resistant|"Patients with ciprofloxacin-resistant bacteria on their rectal swab will receive one of the following drugs:~trimethoprim-sulfamethoxazole 1 double strength tablet orally 2 hours before the procedure and again 12 hours later~cefuroxime 500 mg orally 2 hours before the procedure then again 12 hours later~ceftriaxone 500 mg intramuscularly 2 hours before the procedure~gentamicin 2mg/kg intramuscularly 2 hours before the procedure~amikacin 5 mg/kg intramuscularly 2 hours before the procedure~aztreonam 500 mg intramuscularly 2 hours before the procedure~imipenem 500 mg intramuscularly 2 hours before the procedure~ceftriaxone 2000 mg intravenously 1 hour before the procedure~gentamicin 2 mg/kg intravenously 1 hour before the procedure~amikacin 5mg/kg intravenously 1 hour before the procedure~aztreonam 2000 mg intravenously 1 hour before the procedure~imipenem 1000 mg intravenously 1 hour before the procedure"
11112783|NCT01659866|BG002|Baseline|Total|Total of all reporting groups
10846051|NCT00272779|FG000|Participant Flow|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
11112784|NCT01659866|FG000|Participant Flow|Cipro-susceptible|"Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy~Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy"
11126711|NCT01734902|FG000|Participant Flow|Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)|Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
11112785|NCT01659866|FG001|Participant Flow|Cipro-resistant|"Patients with ciprofloxacin-resistant bacteria on their rectal swab will receive one of the following drugs:~trimethoprim-sulfamethoxazole 1 double strength tablet orally 2 hours before the procedure and again 12 hours later~cefuroxime 500 mg orally 2 hours before the procedure then again 12 hours later~ceftriaxone 500 mg intramuscularly 2 hours before the procedure~gentamicin 2mg/kg intramuscularly 2 hours before the procedure~amikacin 5 mg/kg intramuscularly 2 hours before the procedure~aztreonam 500 mg intramuscularly 2 hours before the procedure~imipenem 500 mg intramuscularly 2 hours before the procedure~ceftriaxone 2000 mg intravenously 1 hour before the procedure~gentamicin 2 mg/kg intravenously 1 hour before the procedure~amikacin 5mg/kg intravenously 1 hour before the procedure~aztreonam 2000 mg intravenously 1 hour before the procedure~imipenem 1000 mg intravenously 1 hour before the procedure"
11112786|NCT01659866|OG000|Outcome|Cipro-susceptible|"Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy~Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy"
11112787|NCT01659866|OG001|Outcome|Cipro-resistant|"Patients with ciprofloxacin-resistant bacteria on their rectal swab will receive one of the following drugs:~trimethoprim-sulfamethoxazole 1 double strength tablet orally 2 hours before the procedure and again 12 hours later~cefuroxime 500 mg orally 2 hours before the procedure then again 12 hours later~ceftriaxone 500 mg intramuscularly 2 hours before the procedure~gentamicin 2mg/kg intramuscularly 2 hours before the procedure~amikacin 5 mg/kg intramuscularly 2 hours before the procedure~aztreonam 500 mg intramuscularly 2 hours before the procedure~imipenem 500 mg intramuscularly 2 hours before the procedure~ceftriaxone 2000 mg intravenously 1 hour before the procedure~gentamicin 2 mg/kg intravenously 1 hour before the procedure~amikacin 5mg/kg intravenously 1 hour before the procedure~aztreonam 2000 mg intravenously 1 hour before the procedure~imipenem 1000 mg intravenously 1 hour before the procedure"
11112788|NCT01659866|EG000|Reported Event|Cipro-susceptible|"Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy~Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy"
11112789|NCT01659866|EG001|Reported Event|Cipro-resistant|"Patients with ciprofloxacin-resistant bacteria on their rectal swab will receive one of the following drugs:~trimethoprim-sulfamethoxazole 1 double strength tablet orally 2 hours before the procedure and again 12 hours later~cefuroxime 500 mg orally 2 hours before the procedure then again 12 hours later~ceftriaxone 500 mg intramuscularly 2 hours before the procedure~gentamicin 2mg/kg intramuscularly 2 hours before the procedure~amikacin 5 mg/kg intramuscularly 2 hours before the procedure~aztreonam 500 mg intramuscularly 2 hours before the procedure~imipenem 500 mg intramuscularly 2 hours before the procedure~ceftriaxone 2000 mg intravenously 1 hour before the procedure~gentamicin 2 mg/kg intravenously 1 hour before the procedure~amikacin 5mg/kg intravenously 1 hour before the procedure~aztreonam 2000 mg intravenously 1 hour before the procedure~imipenem 1000 mg intravenously 1 hour before the procedure"
11112790|NCT01659996|BG000|Baseline|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
11112791|NCT01659996|BG001|Baseline|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
11112792|NCT01659996|BG002|Baseline|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
11112793|NCT01659996|BG003|Baseline|Total|Total of all reporting groups
11112794|NCT01659996|FG000|Participant Flow|Menactra Vaccine Group|All participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
11112795|NCT01659996|FG001|Participant Flow|Menactra + Pentacel Vaccine Group|All participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
11112796|NCT01659996|FG002|Participant Flow|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
11112797|NCT01659996|OG000|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
11112798|NCT01659996|OG001|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
11112799|NCT01659996|OG002|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
11112800|NCT01659996|OG000|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
11112801|NCT01659996|OG002|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
11112802|NCT01659996|EG000|Reported Event|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
11112803|NCT01659996|EG001|Reported Event|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
11112804|NCT01659996|EG002|Reported Event|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
11112805|NCT01660022|BG000|Baseline|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 160 mg
11112806|NCT01660022|BG001|Baseline|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 480 mg
11112807|NCT01660022|BG002|Baseline|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 1440 mg
11112808|NCT01660022|BG003|Baseline|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300 mg / PQP 1440 mg
11112809|NCT01660022|BG004|Baseline|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800 mg / PQP 1440 mg
11112810|NCT01660022|BG005|Baseline|Placebo|Cohorts 1, 2, 3, 4 and 5
11112811|NCT01660022|BG006|Baseline|Total|Total of all reporting groups
11112812|NCT01660022|FG000|Participant Flow|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg / PQP 160mg
11112813|NCT01660022|FG001|Participant Flow|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 480mg
11112814|NCT01660022|FG002|Participant Flow|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 1440mg
11112815|NCT01660022|FG003|Participant Flow|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300mg+PQP 1440mg
11112816|NCT01660022|FG004|Participant Flow|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800mg+PQP 1440mg
11112817|NCT01660022|FG005|Participant Flow|Placebo|Cohorts 1, 2, 3, 4 and 5
11112818|NCT01660022|OG000|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
11112819|NCT01660022|OG001|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
11112820|NCT01660022|OG002|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
11112821|NCT01660022|OG003|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
11112822|NCT01660022|OG004|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
11112823|NCT01660022|OG005|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
11112824|NCT01660022|OG006|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
11112825|NCT01660022|OG007|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
11112826|NCT01660022|OG008|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
11112827|NCT01660022|OG009|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
11112828|NCT01660022|OG000|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
11112829|NCT01660022|OG001|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
11112830|NCT01660022|OG002|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
11112831|NCT01660022|OG003|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
11112832|NCT01660022|OG004|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
11112833|NCT01660022|EG000|Reported Event|OZ439 100mg|Cohorts 1, 2 and 3 OZ439 100mg
11112834|NCT01660022|EG001|Reported Event|OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
11112835|NCT01660022|EG002|Reported Event|OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
11112836|NCT01660022|EG003|Reported Event|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
11112837|NCT01660022|EG004|Reported Event|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
11112838|NCT01660022|EG005|Reported Event|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
11112839|NCT01660022|EG006|Reported Event|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
11112840|NCT01660022|EG007|Reported Event|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
11112841|NCT01660022|EG008|Reported Event|Placebo|Cohorts 1, 2, 3, 4 and 5
11112842|NCT01660191|BG000|Baseline|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
11112843|NCT01660191|BG001|Baseline|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
11112844|NCT01660191|BG002|Baseline|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
11112845|NCT01660191|BG003|Baseline|Total|Total of all reporting groups
11112846|NCT01660191|FG000|Participant Flow|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
11112847|NCT01660191|FG001|Participant Flow|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
11112848|NCT01660191|FG002|Participant Flow|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
11112849|NCT01660191|OG000|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
11112850|NCT01660191|OG001|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
11112851|NCT01660191|OG002|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
11112852|NCT01660191|EG000|Reported Event|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
11112853|NCT01660191|EG001|Reported Event|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
11112854|NCT01660191|EG002|Reported Event|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
11112855|NCT01660230|BG000|Baseline|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112856|NCT01660230|BG001|Baseline|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112857|NCT01660230|BG002|Baseline|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112858|NCT01660230|BG003|Baseline|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112859|NCT01660230|BG004|Baseline|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112860|NCT01660230|BG005|Baseline|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112861|NCT01660230|BG006|Baseline|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112862|NCT01660230|BG007|Baseline|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112863|NCT01660230|BG008|Baseline|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112864|NCT01660230|BG009|Baseline|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112865|NCT01660230|BG010|Baseline|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112866|NCT01660230|BG011|Baseline|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
11112867|NCT01660230|BG012|Baseline|Total|Total of all reporting groups
11112868|NCT01660230|FG000|Participant Flow|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112869|NCT01660230|FG001|Participant Flow|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112870|NCT01660230|FG002|Participant Flow|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112871|NCT01660230|FG003|Participant Flow|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112872|NCT01660230|FG004|Participant Flow|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112873|NCT01660230|FG005|Participant Flow|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112874|NCT01660230|FG006|Participant Flow|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112875|NCT01660230|FG007|Participant Flow|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112876|NCT01660230|FG008|Participant Flow|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112877|NCT01660230|FG009|Participant Flow|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112878|NCT01660230|FG010|Participant Flow|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112879|NCT01660230|FG011|Participant Flow|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
11112880|NCT01660230|OG000|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112881|NCT01660230|OG001|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112882|NCT01660230|OG002|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112883|NCT01660230|OG003|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112884|NCT01660230|OG004|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112885|NCT01660230|OG005|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112886|NCT01660230|OG006|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112887|NCT01660230|OG007|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
11112888|NCT01660230|OG000|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112889|NCT01660230|OG001|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112890|NCT01660230|OG002|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112891|NCT01660230|OG003|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112892|NCT01660230|OG004|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
11112893|NCT01660230|EG000|Reported Event|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112894|NCT01660230|EG001|Reported Event|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112895|NCT01660230|EG002|Reported Event|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112896|NCT01660230|EG003|Reported Event|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112897|NCT01660230|EG004|Reported Event|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112898|NCT01660230|EG005|Reported Event|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112899|NCT01660230|EG006|Reported Event|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112900|NCT01660230|EG007|Reported Event|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112901|NCT01660230|EG008|Reported Event|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112902|NCT01660230|EG009|Reported Event|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112903|NCT01660230|EG010|Reported Event|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
11112904|NCT01660230|EG011|Reported Event|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
11112905|NCT01660256|BG000|Baseline|OPC-12759 Solution|One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks.
11112906|NCT01660256|BG001|Baseline|Placebo|One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks.
11112907|NCT01660256|BG002|Baseline|OPC-12759 Suspension|One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks.
11112908|NCT01660256|BG003|Baseline|Total|Total of all reporting groups
11112909|NCT01660256|FG000|Participant Flow|OPC-12759 Solution|One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks.
11112910|NCT01660256|FG001|Participant Flow|Placebo|One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks.
11112911|NCT01660256|FG002|Participant Flow|OPC-12759 Suspension|One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks.
11112912|NCT01660256|OG000|Outcome|OPC-12759 Solution|One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks.
11112913|NCT01660256|OG001|Outcome|Placebo|One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks.
11112914|NCT01660256|OG002|Outcome|OPC-12759 Suspension|One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks.
11112915|NCT01660256|EG000|Reported Event|OPC-12759 Solution|One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks.
11112916|NCT01660256|EG001|Reported Event|Placebo|One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks.
11112917|NCT01660256|EG002|Reported Event|OPC-12759 Suspension|One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks.
11112918|NCT01660321|BG000|Baseline|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
11112919|NCT01660321|FG000|Participant Flow|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
11112920|NCT01660321|OG000|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
11112921|NCT01660321|EG000|Reported Event|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
11112922|NCT01660334|BG000|Baseline|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
11112923|NCT01660334|FG000|Participant Flow|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
11112924|NCT01660334|OG000|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
11112925|NCT01660334|EG000|Reported Event|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
11112926|NCT01660412|BG000|Baseline|All Study Participants|"Subjects were randomized into 1 of 2 sequence groups (A and B):~Sequence group A. The first injection administered was the standard-of-care (SOC) solution followed by the pH-altered solution. The remaining injections were randomly assigned as either SOC solution or pH-altered.~Sequence group B. The first injection administered was the pHaltered solution followed by the SOC solution. The remaining injections were randomly assigned as either SOC solution or pH-altered."
11112927|NCT01660412|FG000|Participant Flow|pH Altered First|"The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.~ph Altered first: For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given."
11112928|NCT01660412|FG001|Participant Flow|Standard of Care First|"The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.~Standard of Care First: For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40."
11112929|NCT01660412|OG000|Outcome|Standard of Care Injection|Approximately 1mc 99mTc-SC
11112930|NCT01660412|OG001|Outcome|PH Altered Injection|a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc
11112931|NCT01660412|EG000|Reported Event|Standard of Care Injection|Approximately 1mc 99mTc-SC
11112932|NCT01660412|EG001|Reported Event|PH Altered Injection|a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc
11112933|NCT01660672|BG000|Baseline|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
11112934|NCT01660672|FG000|Participant Flow|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
11112935|NCT01660672|OG000|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
11112936|NCT01660672|OG000|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
11112937|NCT01660672|EG000|Reported Event|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. This dose was effective in 7/7 children."
11112938|NCT01660698|BG000|Baseline|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
11112939|NCT01660698|BG001|Baseline|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
11112940|NCT01660698|BG002|Baseline|Total|Total of all reporting groups
11112941|NCT01660698|FG000|Participant Flow|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
11112942|NCT01660698|FG001|Participant Flow|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
11112943|NCT01660698|OG000|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
11112944|NCT01660698|OG001|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
11112945|NCT01660698|EG000|Reported Event|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
11112946|NCT01660698|EG001|Reported Event|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
11112947|NCT01660711|BG000|Baseline|FOLFIRINOX Chemotherapy|All participants.
11112948|NCT01660711|FG000|Participant Flow|FOLFIRINOX Chemotherapy|"5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1~Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery.~5 Fluorouracil: 2400 mg/m2 by continuous intravenous infusion over 46 hours~Leucovorin: 400 mg/m2 by IV infusion over 2 hours~Irinotecan: 180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)~Oxaliplatin: 85 mg/m² IV infusion on Day 1 over 2 hours"
11112949|NCT01660711|OG000|Outcome|FOLFIRINOX Chemotherapy|"5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1~Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery.~5 Fluorouracil: 2400 mg/m2 by continuous intravenous infusion over 46 hours~Leucovorin: 400 mg/m2 by IV infusion over 2 hours~Irinotecan: 180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)~Oxaliplatin: 85 mg/m² IV infusion on Day 1 over 2 hours"
11112950|NCT01660711|EG000|Reported Event|FOLFIRINOX Chemotherapy|FOLFIRINOX chemotherapy in all participants.
11112951|NCT01660737|BG000|Baseline|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
11112952|NCT01660737|FG000|Participant Flow|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
11112953|NCT01660737|OG000|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
11112954|NCT01660737|EG000|Reported Event|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
11112955|NCT01660763|BG000|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
11112956|NCT01660763|BG001|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
11112957|NCT01660763|BG002|Baseline|Total|Total of all reporting groups
11112958|NCT01660763|FG000|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
11112959|NCT01660763|FG001|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
11112960|NCT01660763|OG000|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
11112961|NCT01660763|OG001|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
11112962|NCT01660763|EG000|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
11112963|NCT01660763|EG001|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
11112964|NCT01660802|BG000|Baseline|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
11112965|NCT01660802|BG001|Baseline|Sham|Sham administered in the study eye on Day 1.
11112966|NCT01660802|BG002|Baseline|Total|Total of all reporting groups
11112967|NCT01660802|FG000|Participant Flow|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
11112968|NCT01660802|FG001|Participant Flow|Sham|Sham administered in the study eye on Day 1.
11112969|NCT01660802|OG000|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
11112970|NCT01660802|OG001|Outcome|Sham|Sham administered in the study eye on Day 1.
11112971|NCT01660802|EG000|Reported Event|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
11112972|NCT01660802|EG001|Reported Event|Sham|Sham administered in the study eye on Day 1.
11112973|NCT01660815|BG000|Baseline|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
11112974|NCT01660815|FG000|Participant Flow|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
11112975|NCT01660815|OG000|Outcome|50-kg Model|Radiation dose estimate using a 50-kg model.
11112976|NCT01660815|OG001|Outcome|70-kg Model|Radiation dose estimate using a 70-kg model.
11112977|NCT01660815|EG000|Reported Event|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
11112978|NCT01660893|BG000|Baseline|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
11112979|NCT01660893|BG001|Baseline|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
11112980|NCT01660893|BG002|Baseline|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
11112981|NCT01660893|BG003|Baseline|Total|Total of all reporting groups
11112982|NCT01660893|FG000|Participant Flow|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
11112983|NCT01660893|FG001|Participant Flow|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
11112984|NCT01660893|FG002|Participant Flow|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
11112985|NCT01660893|OG000|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
11112986|NCT01660893|OG001|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
11112987|NCT01660893|OG002|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
11112988|NCT01660893|EG000|Reported Event|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
11112989|NCT01660893|EG001|Reported Event|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
11112990|NCT01660893|EG002|Reported Event|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
11112991|NCT01660906|BG000|Baseline|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
11112992|NCT01660906|FG000|Participant Flow|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
11112993|NCT01660906|OG000|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
11112994|NCT01660906|EG000|Reported Event|Dasatinib|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
11112995|NCT01661062|BG000|Baseline|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
11112996|NCT01661062|FG000|Participant Flow|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
11112997|NCT01661062|OG000|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
11112998|NCT01661062|EG000|Reported Event|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
11112999|NCT01661088|BG000|Baseline|Study Treatment|"Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.~Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.~Patients without metastatic disease were offered surgical exploration."
11113000|NCT01661088|FG000|Participant Flow|Study Treatment|"Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.~Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.~Patients without metastatic disease were offered surgical exploration."
11113001|NCT01661088|OG000|Outcome|Study Treatment|"Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.~Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.~Patients without metastatic disease were offered surgical exploration."
11113002|NCT01661088|EG000|Reported Event|Study Treatment|"Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.~Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.~Patients without metastatic disease were offered surgical exploration."
11113003|NCT01661114|BG000|Baseline|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
11113004|NCT01661114|FG000|Participant Flow|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
11113005|NCT01661114|OG000|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
11113006|NCT01661114|EG000|Reported Event|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
11113007|NCT01661140|BG000|Baseline|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label MTX for 24 weeks.
11113008|NCT01661140|FG000|Participant Flow|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label methotrexate (MTX) for 24 weeks, which was the initial phase of the study.
11113009|NCT01661140|FG001|Participant Flow|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
11113010|NCT01661140|FG002|Participant Flow|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
11113011|NCT01661140|OG000|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
11113012|NCT01661140|OG001|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
11113013|NCT01661140|OG001|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy..
11113014|NCT01661140|EG000|Reported Event|Initial Phase|"At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks, which is the initial phase of the study.~Adverse events in this reporting group are those occurring in the open-label phase only."
11113015|NCT01661140|EG001|Reported Event|Methotrexate (MTX) Tapering Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.~Adverse events in this reporting group are those occurring in the double-blind phase only."
11113016|NCT01661140|EG002|Reported Event|Methotrexate (MTX) Maintenance Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.~Adverse events in this reporting group are those occurring in the double-blind phase only."
11113017|NCT01661179|BG000|Baseline|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
11113018|NCT01661179|FG000|Participant Flow|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
11113019|NCT01661179|OG000|Outcome|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
11113020|NCT01661179|EG000|Reported Event|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
11113021|NCT01661205|BG000|Baseline|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
11113022|NCT01661205|FG000|Participant Flow|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
11113023|NCT01661205|OG000|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
11113024|NCT01661205|EG000|Reported Event|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
11113025|NCT01661270|BG000|Baseline|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
11113026|NCT01661270|BG001|Baseline|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
11113027|NCT01661270|BG002|Baseline|Total|Total of all reporting groups
11113028|NCT01661270|FG000|Participant Flow|Placebo|Placebo for aflibercept intravenous (IV) infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
11113029|NCT01661270|FG001|Participant Flow|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
11113030|NCT01661270|OG000|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
11113031|NCT01661270|OG001|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
11113032|NCT01661270|EG000|Reported Event|Placebo Only|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
11113033|NCT01661270|EG001|Reported Event|Aflibercept Only|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
11113034|NCT01661270|EG002|Reported Event|Mixed Administration (Placebo and Aflibercept)|Participants who were originally randomized to receive either Placebo or Aflibercept, actually received both the treatment (Placebo and Aflibercept).
11113035|NCT01661283|BG000|Baseline|Treatment|"Everolimus (2.5, 5, and 10 mg tablets) was administered at 10 mg per dose once daily at the same time on a continuous dosing schedule.~Bevacizumab (400 mg vials) was administered at 10 mg/kg as intravenous infusion over 30-90 minutes every 2 weeks (days 1 and 15).~One treatment cycle was 28 days."
11113036|NCT01661283|FG000|Participant Flow|Treatment|"Everolimus (2.5, 5, and 10 mg tablets) was administered at 10 mg per dose once daily at the same time on a continuous dosing schedule.~Bevacizumab (400 mg vials) was administered at 10 mg/kg as intravenous infusion over 30-90 minutes every 2 weeks (days 1 and 15).~One treatment cycle was 28 days."
11113037|NCT01661283|OG000|Outcome|Treatment|"Everolimus (2.5, 5, and 10 mg tablets) was administered at 10 mg per dose once daily at the same time on a continuous dosing schedule.~Bevacizumab (400 mg vials) was administered at 10 mg/kg as intravenous infusion over 30-90 minutes every 2 weeks (days 1 and 15).~One treatment cycle was 28 days."
11113038|NCT01661283|EG000|Reported Event|Treatment|"Everolimus (2.5, 5, and 10 mg tablets) was administered at 10 mg per dose once daily at the same time on a continuous dosing schedule.~Bevacizumab (400 mg vials) was administered at 10 mg/kg as intravenous infusion over 30-90 minutes every 2 weeks (days 1 and 15).~One treatment cycle was 28 days."
11113039|NCT01661595|BG000|Baseline|Sildenafil, Then Placebo|Sildenafil (50mg/day) daily for weeks 0-4, then Placebo daily weeks 5-8.
11113040|NCT01661595|BG001|Baseline|Tadalfil, Then Placebo|Tadalafil (10mg/day) daily for weeks 0-4, then Placebo daily for weeks 5-8.
11113041|NCT01661595|BG002|Baseline|Placebo, Then Sildenafil|Placebo daily for weeks 0-4, then Sildenafil (50mg/day) daily for weeks 5-8.
11113042|NCT01661595|BG003|Baseline|Placebo, Then Tadalafil|Placebo daily for weeks 0-4, then Tadalafil (10mg/day) daily for weeks 5-8.
11113043|NCT01661595|BG004|Baseline|Total|Total of all reporting groups
11113044|NCT01661595|FG000|Participant Flow|Sildenafil, Then Placebo|Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.
11113045|NCT01661595|FG001|Participant Flow|Tadalfil, Then Placebo|Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.
11113046|NCT01661595|FG002|Participant Flow|Placebo, Then Sildenafil|Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.
11113047|NCT01661595|FG003|Participant Flow|Placebo, Then Tadalafil|Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.
11113048|NCT01661595|OG000|Outcome|Sildenafil, Then Placebo|"50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8.~Sildenafil: 50 mg/day for 4 weeks~Placebo: Placebo 1 capsule per day for four weeks."
11113049|NCT01661595|OG001|Outcome|Tadalafil, Then Placebo|"10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8.~tadalafil: 10 mg/day for 4 weeks.~Placebo: Placebo 1 capsule per day for four weeks."
11113050|NCT01661595|OG002|Outcome|Placebo, Then Sildenafil|"Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8.~Sildenafil: 50 mg/day for 4 weeks~Placebo: Placebo 1 capsule per day for four weeks."
11113051|NCT01661595|OG003|Outcome|Placebo, Then Tadalafil|"Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8.~tadalafil: 10 mg/day for 4 weeks.~Placebo: Placebo 1 capsule per day for four weeks."
11113052|NCT01661595|OG000|Outcome|Sildenafil / Placebo|"50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8.~Sildenafil: 50 mg/day for 4 weeks~Placebo: Placebo 1 capsule per day for four weeks."
11113053|NCT01661595|OG001|Outcome|Tadalafil / Placebo|"10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8.~tadalafil: 10 mg/day for 4 weeks.~Placebo: Placebo 1 capsule per day for four weeks."
11113054|NCT01661595|OG002|Outcome|Placebo / Sildenafil|"Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8.~Sildenafil: 50 mg/day for 4 weeks~Placebo: Placebo 1 capsule per day for four weeks."
11113055|NCT01661595|OG003|Outcome|Placebo / Tadalafil|"Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8.~tadalafil: 10 mg/day for 4 weeks.~Placebo: Placebo 1 capsule per day for four weeks."
11113056|NCT01661595|OG000|Outcome|Sildenafil, Then Placebo|Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.
11113057|NCT01661595|OG001|Outcome|Tadalfil, Then Placebo|Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.
11113058|NCT01661595|OG002|Outcome|Placebo, Then Sildenafil|Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.
11113059|NCT01661595|OG003|Outcome|Placebo, Then Tadalafil|Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.
11113060|NCT01661595|EG000|Reported Event|Sildenafil|Sildenafil (50mg/day) daily for 4 weeks.
11113061|NCT01661595|EG001|Reported Event|Tadalfil|Tadalafil (10mg/day) daily for 4 weeks.
11113062|NCT01661595|EG002|Reported Event|Placebo|Placebo daily for week 4 weeks.
11113063|NCT01661621|BG000|Baseline|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
11113064|NCT01661621|BG001|Baseline|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
11113065|NCT01661621|BG002|Baseline|Total|Total of all reporting groups
11113066|NCT01661621|FG000|Participant Flow|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
11113067|NCT01661621|FG001|Participant Flow|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
11113068|NCT01661621|OG000|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
11113069|NCT01661621|OG001|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
11113070|NCT01661621|EG000|Reported Event|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
11113071|NCT01661621|EG001|Reported Event|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
11113072|NCT01661686|BG000|Baseline|Insertion of a Partially Covered SEMS|Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
11113073|NCT01661686|BG001|Baseline|Insertion of a Fully Covered SEMS|Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
11113074|NCT01661686|BG002|Baseline|Total|Total of all reporting groups
11113075|NCT01661686|FG000|Participant Flow|Insertion of a Partially Covered SEMS|Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
11113076|NCT01661686|FG001|Participant Flow|Insertion of a Fully Covered SEMS|Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
11113077|NCT01661686|OG000|Outcome|Insertion of a Partially Covered SEMS|Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
11113078|NCT01661686|OG001|Outcome|Insertion of a Fully Covered SEMS|Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
11113079|NCT01661686|EG000|Reported Event|Insertion of a Partially Covered SEMS|Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
11113080|NCT01661686|EG001|Reported Event|Insertion of a Fully Covered SEMS|Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
11113081|NCT01661712|BG000|Baseline|Sham Stimulation First, Then Transcutaneous Electrical Stimula|"The patient will undergo a sleep study and continuous transcutaneous electrical stimulation will be administered during the night. After 3 days of wash out the patient will undergo a sleep study with the sham intervention and no continuous transcutaneous electrical stimulation will be administered.~An identical setup to the intervention will be used with the software indicating stimulation to keep staff blinded to the intervention.~Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation&Technology ltd., Petersfield, UK): The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external PC or laptop via a visual interface.~It stimulates the pharyngeal dilator muscles in order to reduce sleep apnoea."
11113082|NCT01661712|BG001|Baseline|Transcutaneous Electrical Stimulation First, Then Sham Stimula|"The patient will undergo a sleep study with Sham stimulation. After 3 days of wash out the patient will will undergo a sleep study and continuous transcutaneous electrical stimulation will be administered during the night An identical setup to the intervention will be used with the software indicating stimulation to keep staff blinded to the intervention.~Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation&Technology ltd., Petersfield, UK): The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external PC or laptop via a visual interface.~It stimulates the pharyngeal dilator muscles in order to reduce sleep apnoea."
11113083|NCT01661712|BG002|Baseline|Total|Total of all reporting groups
11113084|NCT01661712|FG000|Participant Flow|Sham Stimulation, Then True Stimulation|"The patient will 1st undergo a sleep study with Sham stimulation. An identical setup to the intervention will be used with the software indicating stimulation to keep staff blinded to the intervention.~Then patients will undergo a washout period (>3nights) and return for a 2nd sleep study on true stimulation to complete the trial.~Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation&Technology Ltd., Petersfield, UK):~The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external personal computer (PC) or laptop via a visual interface. It stimulates the pharyngeal dilator muscles to reduce sleep apnoea."
11113085|NCT01661712|FG001|Participant Flow|Transcutaneous Electrical Stimulation, Then Sham Stimulation|"The patient will undergo the 1st sleep study with continuous transcutaneous electrical stimulation.~Then patients will undergo a washout period (>3nights) and return for a 2nd sleep study on sham stimulation to complete the trial.~Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation&Technology ltd., Petersfield, UK):~The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external PC or laptop via a visual interface. It stimulates the pharyngeal dilator muscles to reduce sleep apnoea."
11113086|NCT01661712|OG000|Outcome|Sham Stimulation|patients that underwent the Sham stimulation night study
11113087|NCT01661712|OG001|Outcome|Active Treatment|Patients that underwent the stimulation overnight sleep study
11113088|NCT01661712|OG000|Outcome|Sham Stimulation|sham stimulation night
11113089|NCT01661712|OG001|Outcome|Transcutaneous Electrical Stimulation|Transcutaneous electrical stimulation night
11113090|NCT01661712|OG000|Outcome|Transcutaneous Electrical Stimulation|"Transcutaneous electrical stimulation: the patient will undergo a sleep study and continuous transcutaneous electrical stimulation during the night (active treatment).~Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation&Technology ltd., Petersfield, UK): The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external PC or laptop via a visual interface.~It stimulates the pharyngeal dilator muscles in order to reduce sleep apnoea."
11113091|NCT01661712|OG001|Outcome|Sham Stimulation|"Sham stimulation: the patient will undergo a sleep study with Sham stimulation. An identical setup to the intervention will be used with the software indicating stimulation to keep staff blinded to the intervention (Modes are labelled A and B for real and sham stimulation and observers will not be able to tell the difference on the screen).~Sham stimulation (SOSATS device, MORGAN Innovation&Technology ltd., Petersfield, UK): The patient will undergo a sleep study with sham transcutaneous electrical stimulation. The setup will be identical to the intervention, but a blinded mode in the software application will stop triggering electrical current despite indicating on the monitor that stimulation is being applied."
11113092|NCT01661712|OG000|Outcome|Transcutaneous Electrical Stimulation|Transcutaneous electrical stimulation night
11113093|NCT01661712|OG001|Outcome|Sham Stimulation|Sham stimulation night
11113094|NCT01661712|EG000|Reported Event|Sham Stimulation|patients that underwent the Sham stimulation night study
11113095|NCT01661712|EG001|Reported Event|Active Treatment|Patients that underwent the stimulation overnight sleep study
11113096|NCT01661764|BG000|Baseline|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113097|NCT01661764|BG001|Baseline|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113098|NCT01661764|BG002|Baseline|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113099|NCT01661764|BG003|Baseline|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113100|NCT01661764|BG004|Baseline|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113101|NCT01661764|BG005|Baseline|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113102|NCT01661764|BG006|Baseline|Total|Total of all reporting groups
11113103|NCT01661764|FG000|Participant Flow|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113104|NCT01661764|FG001|Participant Flow|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113105|NCT01661764|FG002|Participant Flow|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113106|NCT01661764|FG003|Participant Flow|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113107|NCT01661764|FG004|Participant Flow|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113108|NCT01661764|FG005|Participant Flow|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113109|NCT01661764|OG000|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113110|NCT01661764|OG001|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113111|NCT01661764|OG002|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113112|NCT01661764|OG003|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113113|NCT01661764|OG004|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113114|NCT01661764|OG005|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113115|NCT01661764|EG000|Reported Event|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113116|NCT01661764|EG001|Reported Event|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113117|NCT01661764|EG002|Reported Event|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113118|NCT01661764|EG003|Reported Event|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113119|NCT01661764|EG004|Reported Event|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
11113120|NCT01661764|EG005|Reported Event|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
11113121|NCT01661790|BG000|Baseline|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
11113122|NCT01661790|BG001|Baseline|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
11113123|NCT01661790|BG002|Baseline|Total|Total of all reporting groups
11113124|NCT01661790|FG000|Participant Flow|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,each 2 week"
11113125|NCT01661790|FG001|Participant Flow|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
11113126|NCT01661790|OG000|Outcome|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
11113127|NCT01661790|OG001|Outcome|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
11113128|NCT01661790|EG000|Reported Event|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
11113129|NCT01661790|EG001|Reported Event|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
11113130|NCT01661933|BG000|Baseline|Gluten Micro-challenge|Single arm, vertical. All twelve healthy adults enrolled subjects were successfully inoculated with hookworm and there was no serious adverse response. Individual hemoglobin levels were all normal and the group mean had significantly increased unexpectedly at completion of the study. Histology was not graded until after low-dose challenge but retrospectively confirmed enrollment Marsh scores of M0-8, M1-1, M2-2 and M3a-1. All participants were complying with a gluten-free diet, were symptomatically well and had a normal anti-tTG.
11113131|NCT01661933|FG000|Participant Flow|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
11113132|NCT01661933|OG000|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, assessments including histology were performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
11113133|NCT01661933|OG000|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
11113134|NCT01661933|OG000|Outcome|Necator Americanus, Pre-gluten Challenge|Single arm, vertical. Ten of 12 participants enrolled based on symptomatic tolerance of gluten and satisfactory histology during and after micro-challenge. 2 were withdrawn pre-GC-1g, one who was symptomatically intolerant of gluten and one who had M3a after micro-challenge. Pre-GC1g scores.
11113135|NCT01661933|EG000|Reported Event|Gluten Micro-challenge|Single arm, longitudinal study of responses to escalating gluten doses in people with celiac disease after infection with Necator americanus, a human hookworm.
11113136|NCT01661946|BG000|Baseline|Bevacizumab|
11113137|NCT01661946|BG001|Baseline|Ranibizumab|
11113138|NCT01661946|BG002|Baseline|Total|Total of all reporting groups
11113139|NCT01661946|FG000|Participant Flow|Ranibizumab|"intravitreal injection of 0.5mg ranibizumab in usual fashion~Ranibizumab: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use"
11113140|NCT01661946|FG001|Participant Flow|Bevacizumab|"intravitreal injection of 1.25mg bevacizumab in usual fashion~Bevacizumab: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema."
11113141|NCT01661946|OG000|Outcome|Ranibizumab|"intravitreal injection of 0.5mg ranibizumab in usual fashion~Ranibizumab: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use"
11113142|NCT01661946|OG001|Outcome|Bevacizumab|"intravitreal injection of 1.25mg bevacizumab in usual fashion~Bevacizumab: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema."
11113143|NCT01661946|EG000|Reported Event|Ranibizumab|"intravitreal injection of 0.5mg ranibizumab in usual fashion~Ranibizumab: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use"
11113144|NCT01661946|EG001|Reported Event|Bevacizumab|"intravitreal injection of 1.25mg bevacizumab in usual fashion~Bevacizumab: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema."
11113145|NCT01661972|BG000|Baseline|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
11113146|NCT01661972|BG001|Baseline|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
11113147|NCT01661972|BG002|Baseline|Total|Total of all reporting groups
11113148|NCT01661972|FG000|Participant Flow|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
11113149|NCT01661972|FG001|Participant Flow|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
11113150|NCT01661972|OG000|Outcome|Phase 1|Aflibercept 6 mg/kg given intravenously every 3 weeks. Capecitabine was given at 850mg/m2 for the first cohort and at 1000mg/m2 for the second cohort.
11113151|NCT01661972|OG000|Outcome|Phase 1 Cohort 1|Capecitabine 850mg/m2 given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
11113152|NCT01661972|OG001|Outcome|Phase 1 Cohort 2|Capecitabine 1000 mg/m2 given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
11113153|NCT01661972|OG000|Outcome|Phase 2|Capecitabine at the recommended dose based on Phase 1, given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
11113154|NCT01661972|EG000|Reported Event|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
11113155|NCT01661972|EG001|Reported Event|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
11113156|NCT01662024|BG000|Baseline|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures"
11113157|NCT01662024|FG000|Participant Flow|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period."
11113158|NCT01662024|OG000|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period."
11113159|NCT01662024|OG000|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. D"
11113160|NCT01662024|OG000|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
11113161|NCT01662024|OG000|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures"
11113162|NCT01662024|EG000|Reported Event|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
11113163|NCT01662063|BG000|Baseline|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
11113164|NCT01662063|BG001|Baseline|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
11113165|NCT01662063|BG002|Baseline|Total|Total of all reporting groups
11113166|NCT01662063|FG000|Participant Flow|Subcutaneous (SC) Tocilizumab (TCZ) Every 2 Weeks (Q2W)|Participants with moderate to severe rheumatoid arthritis (RA) who completed treatment with SC or intravenous (IV) TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this long-term extension (LTE) study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 milligrams (mg) Q2W.
11113167|NCT01662063|FG001|Participant Flow|SC TCZ Every Week (QW)|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
11113168|NCT01662063|FG002|Participant Flow|Not Treated|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) were enrolled in this LTE study for an additional 96 weeks. Participants who met Screening criteria but did not receive treatment were excluded from analysis and reported in a separate arm.
11113169|NCT01662063|OG000|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
11113170|NCT01662063|OG001|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
11113171|NCT01662063|OG000|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
11113172|NCT01662063|OG000|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
11113173|NCT01662063|EG000|Reported Event|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
11113174|NCT01662063|EG001|Reported Event|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
11113175|NCT01662115|BG000|Baseline|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
11113176|NCT01662115|BG001|Baseline|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
11113177|NCT01662115|BG002|Baseline|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
11113178|NCT01662115|BG003|Baseline|Total|Total of all reporting groups
11113179|NCT01662115|FG000|Participant Flow|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
11113180|NCT01662115|FG001|Participant Flow|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
11113181|NCT01662115|FG002|Participant Flow|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
11113182|NCT01662115|OG000|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
11113183|NCT01662115|OG001|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
11113184|NCT01662115|OG002|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
11113185|NCT01662115|EG000|Reported Event|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
11113186|NCT01662115|EG001|Reported Event|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
11113187|NCT01662115|EG002|Reported Event|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
11113188|NCT01662297|BG000|Baseline|Quetiapine|"Veterans remaining on quetiapine for insomnia.~Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia."
11113189|NCT01662297|BG001|Baseline|Trazodone|"Veterans switching from quetiapine to trazodone for the treatment of insomnia.~Trazodone: Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily."
11113190|NCT01662297|BG002|Baseline|Total|Total of all reporting groups
11113191|NCT01662297|FG000|Participant Flow|Quetiapine|"Veterans remaining on quetiapine for insomnia.~Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia."
11113192|NCT01662297|FG001|Participant Flow|Trazodone|"Veterans switching from quetiapine to trazodone for the treatment of insomnia.~Trazodone: Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily."
11113193|NCT01662297|OG000|Outcome|Quetiapine|"Veterans remaining on quetiapine for insomnia.~Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia."
11113194|NCT01662297|OG001|Outcome|Trazodone|"Veterans switching from quetiapine to trazodone for the treatment of insomnia.~Trazodone: Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily."
11113195|NCT01662297|EG000|Reported Event|Quetiapine|"Veterans remaining on quetiapine for insomnia.~Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia."
11113196|NCT01662297|EG001|Reported Event|Trazodone|"Veterans switching from quetiapine to trazodone for the treatment of insomnia.~Trazodone: Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily."
11113197|NCT01662310|BG000|Baseline|Entire Study Population|All the participants who were enrolled.
11113198|NCT01662310|FG000|Participant Flow|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
11113199|NCT01662310|FG001|Participant Flow|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
11113200|NCT01662310|FG002|Participant Flow|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
11113201|NCT01662310|FG003|Participant Flow|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
11113202|NCT01662310|FG004|Participant Flow|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
11113203|NCT01662310|OG000|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
11113204|NCT01662310|OG001|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
11113205|NCT01662310|OG000|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
11113206|NCT01662310|OG000|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
11113207|NCT01662310|OG001|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
11113208|NCT01662310|EG000|Reported Event|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
11113209|NCT01662310|EG001|Reported Event|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
11113210|NCT01662310|EG002|Reported Event|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
11113211|NCT01662310|EG003|Reported Event|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
11113212|NCT01662310|EG004|Reported Event|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
11113213|NCT01662336|BG000|Baseline|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
11113214|NCT01662336|FG000|Participant Flow|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with lopinavir / ritonavir (LPV/r; Kaletra®) and participation in the Kaletra Adherence Support Assistance (KASA) program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
11113215|NCT01662336|OG000|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
11113216|NCT01662336|OG000|Outcome|Baseline|
11113217|NCT01662336|OG001|Outcome|Month 6|
11113218|NCT01662336|OG002|Outcome|Month 12|
11113219|NCT01662336|OG000|Outcome|Month 6|
11113220|NCT01662336|OG001|Outcome|Month 12|
11113221|NCT01662336|EG000|Reported Event|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
11113222|NCT01662362|BG000|Baseline|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
11113223|NCT01662362|FG000|Participant Flow|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
11113224|NCT01662362|OG000|Outcome|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
11113225|NCT01662362|OG000|Outcome|Testing Donor Specimens With ESA Chagas|Test blood donor specimens that are ABBOTT PRISM Chagas Nonreactive with ESA Chagas. These specimens will be unidentified specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.
11113226|NCT01662362|EG000|Reported Event|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
11113227|NCT01662440|BG000|Baseline|R/JE - Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
11113228|NCT01662440|BG001|Baseline|R/JE - Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
11113229|NCT01662440|BG002|Baseline|R - Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
11113230|NCT01662440|BG003|Baseline|JE - Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
11113231|NCT01662440|BG004|Baseline|Total|Total of all reporting groups
11113232|NCT01662440|FG000|Participant Flow|R/JE - Conv|Subjects received Rabies and Japanese Encephalitis (JE) vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
11113233|NCT01662440|FG001|Participant Flow|R/JE - Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
11113234|NCT01662440|FG002|Participant Flow|R - Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
11113235|NCT01662440|FG003|Participant Flow|JE - Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
11113236|NCT01662440|OG000|Outcome|R/JE - Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
11113237|NCT01662440|OG001|Outcome|R - Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
11113238|NCT01662440|OG001|Outcome|JE - Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
11113239|NCT01662440|OG000|Outcome|R/JE - Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
11113240|NCT01662440|OG001|Outcome|JE - Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
11113241|NCT01662440|OG001|Outcome|JE - Conv|Group Description Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
11113242|NCT01662440|OG001|Outcome|R/JE - Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
11113243|NCT01662440|OG002|Outcome|R - Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
11113244|NCT01662440|OG002|Outcome|JE - Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
11113245|NCT01662440|OG003|Outcome|JE - Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
11113246|NCT01662440|OG000|Outcome|R/JE - Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
11113247|NCT01662440|OG001|Outcome|R/JE - Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
11113248|NCT01662440|OG002|Outcome|R - Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
11113249|NCT01662440|OG003|Outcome|JE - Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
11113250|NCT01662440|EG000|Reported Event|R/JE - Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
11113251|NCT01662440|EG001|Reported Event|R/JE - Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
10848763|NCT00291447|BG001|Baseline|Cohort 2|"Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11113252|NCT01662440|EG002|Reported Event|R - Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
11113253|NCT01662440|EG003|Reported Event|JE - Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
11113254|NCT01662492|BG000|Baseline|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
11113255|NCT01662492|BG001|Baseline|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
11113256|NCT01662492|BG002|Baseline|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
11113257|NCT01662492|BG003|Baseline|Total|Total of all reporting groups
11113258|NCT01662492|FG000|Participant Flow|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
11113259|NCT01662492|FG001|Participant Flow|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
11113260|NCT01662492|FG002|Participant Flow|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
11113261|NCT01662492|OG000|Outcome|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
11113262|NCT01662492|OG001|Outcome|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
11113263|NCT01662492|OG002|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
11113264|NCT01662492|EG000|Reported Event|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
11113265|NCT01662492|EG001|Reported Event|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
11113266|NCT01662492|EG002|Reported Event|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
11113267|NCT01662505|BG000|Baseline|V 350 mg|Patients received 350 milligram (mg) of volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours.
11113268|NCT01662505|BG001|Baseline|V 400 mg|Patients received 400 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113269|NCT01662505|BG002|Baseline|V 450 mg|Patients received 450 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113270|NCT01662505|BG003|Baseline|Total|Total of all reporting groups
11113271|NCT01662505|FG000|Participant Flow|V 350 mg|Patients received 350 milligram (mg) of volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours.
11113272|NCT01662505|FG001|Participant Flow|V 400 mg|Patients received 400 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113273|NCT01662505|FG002|Participant Flow|V 450 mg|Patients received 450 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113274|NCT01662505|OG000|Outcome|V 350 mg|Patients received 350 milligram (mg) of volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours.
11113275|NCT01662505|OG001|Outcome|V 400 mg|Patients received 400 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113276|NCT01662505|OG002|Outcome|V 450 mg|Patients received 450 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113277|NCT01662505|OG000|Outcome|Volasertib|Patients received volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113278|NCT01662505|EG000|Reported Event|V 350 mg|Patients received 350 milligram (mg) of Volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours.
11113279|NCT01662505|EG001|Reported Event|V 400 mg|Patients received 400 mg of Volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113280|NCT01662505|EG002|Reported Event|V 450 mg|Patients received 450 mg of Volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
11113281|NCT01662531|BG000|Baseline|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
11113282|NCT01662531|BG001|Baseline|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
11113283|NCT01662531|BG002|Baseline|Total|Total of all reporting groups
11113284|NCT01662531|FG000|Participant Flow|rIX-FP|"Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.~rIX-FP: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)"
11113285|NCT01662531|OG000|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
11113286|NCT01662531|OG001|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
11113287|NCT01662531|OG002|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
11113288|NCT01662531|EG000|Reported Event|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
11113289|NCT01662583|BG000|Baseline|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
11113290|NCT01662583|BG001|Baseline|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
11113291|NCT01662583|BG002|Baseline|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
11113292|NCT01662583|BG003|Baseline|Total|Total of all reporting groups
11113293|NCT01662583|FG000|Participant Flow|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
11113294|NCT01662583|FG001|Participant Flow|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
11113295|NCT01662583|FG002|Participant Flow|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
11113296|NCT01662583|OG000|Outcome|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
11113297|NCT01662583|OG001|Outcome|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
11113298|NCT01662583|OG002|Outcome|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
11113299|NCT01662583|EG000|Reported Event|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
11113300|NCT01662583|EG001|Reported Event|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
11113301|NCT01662583|EG002|Reported Event|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
11113302|NCT01662635|BG000|Baseline|Demographics and Clinical Features of Overall Population|The baseline characteristics of our population were on basis of the presence or absence of ALK gene.
11113303|NCT01662635|FG000|Participant Flow|Determination of ALK by FISH, IHC and RT-qPCR|"The only inclusion criterion was the availability of tissue for biomarker studies.~We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); using the commercially mouse monoclonal ALK antibody for IHC and . Variants 1, 2, 3a, 4 and 5. The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies)"
11113304|NCT01662635|OG000|Outcome|FISH Test|We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); Abbott Molecular, Abbott Park, IL, USA). Slide washing, and counterstaining by DAPI were done following the manufacturer´s protocol (Abbott Molecular, Abbott Park, IL, USA).
11113305|NCT01662635|OG001|Outcome|IHC Test|using the commercially mouse monoclonal ALK antibody (dilution 1:25, clone 5A4; Abcam, Cambridge, UK), with OptiView DAB detection Kit (Ventana, Tucson, Arizona, USA). ALK IHC was performed according to the protocols provided by the antibody.
11113306|NCT01662635|OG002|Outcome|RT-qPCR Test|The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies) and the following Taqman assays: Hs03654556_ft (E13;A20), Hs03654557_ft (E20;A20), Hs03654558_ft (E6;A20), Hs03654560_ft (E17;A20), and Hs03654559_ft (E18;A20). Hs02758991_ft (GAPDH) assays, whose expression levels are known to be nearly stable among lung tumors
11113307|NCT01662635|EG000|Reported Event|Adverse Events Not Collected|"Serious and Other were not collected/assessed in this observational study."
11113308|NCT01662648|BG000|Baseline|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
11113309|NCT01662648|BG001|Baseline|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
11113310|NCT01662648|BG002|Baseline|Total|Total of all reporting groups
11113311|NCT01662648|FG000|Participant Flow|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
11113312|NCT01662648|FG001|Participant Flow|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
11113313|NCT01662648|OG000|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
11113314|NCT01662648|OG001|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
11113315|NCT01662648|EG000|Reported Event|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
11113316|NCT01662648|EG001|Reported Event|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
11113317|NCT01662752|BG000|Baseline|Indocyanine Green|"Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging~Indocyanine green: Please see arm description"
11113318|NCT01662752|FG000|Participant Flow|Indocyanine Green|Single inject a fluorescent dye (indocyanine green) adjacent to the tumour. The dye will then be seen as it fluoresces in the light form the near infrared spectrum that can be used at the time of the laparoscopic (keyhole) surgery. An endoscope is placed in the colon (colonoscopy) during surgery and the tracer fluorescent agent is injected around the tumour. The mesentery in which the lymph nodes draining the tumour are located will then be examined by laparoscopy as it is expected that fluorescence will be identified within approximately 5 minutes of the injection.
11113319|NCT01662752|OG000|Outcome|Indocyanine Green|"Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging~Indocyanine green: Please see arm description"
11113320|NCT01662752|EG000|Reported Event|Indocyanine Green|"Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging~Indocyanine green: Please see arm description"
11113321|NCT01662765|BG000|Baseline|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry."
11113322|NCT01662765|BG001|Baseline|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
11113323|NCT01662765|BG002|Baseline|Total|Total of all reporting groups
11113324|NCT01662765|FG000|Participant Flow|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
11126712|NCT01734902|FG001|Participant Flow|Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)|Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
11113325|NCT01662765|FG001|Participant Flow|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
11113326|NCT01662765|OG000|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
11113327|NCT01662765|OG001|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
11113328|NCT01662765|OG000|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.~Surgery: modified umbilectomy"
11113329|NCT01662765|OG001|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
11113330|NCT01662765|OG000|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
11113331|NCT01662765|OG001|Outcome|Surgery|Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
11113332|NCT01662765|OG001|Outcome|Surgery|Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
11113333|NCT01662765|EG000|Reported Event|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
11113334|NCT01662765|EG001|Reported Event|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture."
11113335|NCT01662778|BG000|Baseline|All Participants|All participants, crossover study
11113336|NCT01662778|FG000|Participant Flow|First Monodisperse Fluticasone Propionate 6.0 Microns|First 50 micrograms of Monodisperse Fluticasone Propionate delivered as 6.0 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 1.5microns, next is Placebo STAG, and Metered dose inhaler of Fluticasone Propionate last
11113337|NCT01662778|FG001|Participant Flow|First Monodisperse Fluticasone Propionate 1.5microns|First 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns, next is Placebo STAG, and Metered dose inhaler of Fluticasone Propionate last
11113338|NCT01662778|FG002|Participant Flow|First Placebo STAG|First Placebo STAG, then 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns, and Metered dose inhaler of Fluticasone Propionate last
11113339|NCT01662778|FG003|Participant Flow|First Metered Dose Inhaler of Fluticasone Propionate|First Metered dose inhaler of Fluticasone Propionate, then Placebo STAG, then 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, and 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns last
11113340|NCT01662778|OG000|Outcome|Monodisperse FP 1.5um|"50 mg of monodisperse Fluticasone Propionate delivered as 1.5 microns aerosol followed by AMP PC20 challenge test~AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)"
11113341|NCT01662778|OG001|Outcome|Monodisperse FP 6.0um|"50 mg of monodisperse Fluticasone Propionate delivered as 6.0 microns aerosol followed by AMP PC20 challenge test~AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)"
11113342|NCT01662778|OG002|Outcome|Placebo STAG|"No active drug, just solvent delivered from STAG followed by AMP PC20 challenge test~AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)"
11113343|NCT01662778|OG003|Outcome|MDI FP|"Fluticasone Propionate , Metered dose inhaler, 250 mg dose followed by AMP PC20 challenge test~AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)"
11113344|NCT01662778|OG000|Outcome|Monodisperse Fluticasone Propionate 6.0 Microns|"50 micrograms of monodisperse Fluticasone Propionate delivered as 6.0 micrometers~Fluticasone Propionate 50 micrograms: Drug: Fluticasone Propionate Dose 50 micrograms (total dose), Monodisperse aerosol with two differemt particle size of drug (1.5, 6.0 microns) generated by Spinning Top Aerosol Generator (STAG)"
11126713|NCT01734902|OG000|Outcome|Hyoscine Butylbromide Drops (T)|Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.
11113345|NCT01662778|OG001|Outcome|Monodisperse Fluticasone Propionate 1.5microns|"50 micrograms of monodisperse Fluticasone Propionate delivered as 1.5 micrometers~Fluticasone Propionate 50 micrograms: Drug: Fluticasone Propionate Dose 50 micrograms (total dose), Monodisperse aerosol with two differemt particle size of drug (1.5, 6.0 microns) generated by Spinning Top Aerosol Generator (STAG)"
11113346|NCT01662778|OG002|Outcome|Placebo STAG|"No active drug, just solvent delivered from STAG~Placebo monodisperse aerosol dose: Solvent only delivered, no drug"
11113347|NCT01662778|OG003|Outcome|Metered Dose Inhaler of Fluticasone Propionate|"Fluticasone Propionate Inhaled, Metered dose inhaler, 250 micrograms dose (total dose)~Inhaled, Metered dose inhaler, 250 micrograms dose (total dose): Inhaled, Metered dose inhaler, 250 micrograms dose (total dose), delivered via spacer"
11113348|NCT01662778|EG000|Reported Event|Monodisperse FP 1.5um|"50 mg of monodisperse Fluticasone Propionate delivered as 1.5 microns aerosol followed by AMP PC20 challenge test~1.5 microns at 50mg: STAG generated monodisperse 1.5micron particles"
11113349|NCT01662778|EG001|Reported Event|Monodisperse FP 6.0um|"50 mg of monodisperse Fluticasone Propionate delivered as 6.0 microns aerosol followed by AMP PC20 challenge test~6 microns at 50mg: STAG generated monodisperse 6 micron particles"
11113350|NCT01662778|EG002|Reported Event|Placebo STAG|"No active drug, just solvent delivered from STAG followed by AMP PC20 challenge test~Placebo Comparator: No drug just solvent"
11113351|NCT01662778|EG003|Reported Event|MDI FP|"Fluticasone Propionate , Metered dose inhaler, 250 mg dose followed by AMP PC20 challenge test~MDI FP"
11113352|NCT01662791|BG000|Baseline|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
11113353|NCT01662791|BG001|Baseline|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
11113354|NCT01662791|BG002|Baseline|Total|Total of all reporting groups
11113355|NCT01662791|FG000|Participant Flow|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
11113356|NCT01662791|FG001|Participant Flow|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day; they did not take part in the second part of the study.
11113357|NCT01662791|OG000|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
11113358|NCT01662791|OG001|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
11113359|NCT01662791|EG000|Reported Event|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
11113360|NCT01662791|EG001|Reported Event|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
11113361|NCT01662856|BG000|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
11113362|NCT01662856|BG001|Baseline|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
11113363|NCT01662856|BG002|Baseline|Total|Total of all reporting groups
11113364|NCT01662856|FG000|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
11113365|NCT01662856|FG001|Participant Flow|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
11113366|NCT01662856|OG000|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
11113367|NCT01662856|OG001|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
11113368|NCT01662856|EG000|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
11113369|NCT01662856|EG001|Reported Event|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
11113370|NCT01662882|BG000|Baseline|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
11113371|NCT01662882|BG001|Baseline|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
11113372|NCT01662882|BG002|Baseline|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
11113373|NCT01662882|BG003|Baseline|Total|Total of all reporting groups
11113374|NCT01662882|FG000|Participant Flow|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
11113375|NCT01662882|FG001|Participant Flow|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
11113376|NCT01662882|FG002|Participant Flow|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
11113377|NCT01662882|OG000|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
11113378|NCT01662882|OG001|Outcome|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
11113379|NCT01662882|OG002|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
11113380|NCT01662882|EG000|Reported Event|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
11113381|NCT01662882|EG001|Reported Event|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
11113382|NCT01662882|EG002|Reported Event|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
11113383|NCT01662895|BG000|Baseline|Deferoxamine|"Deferoxamine mesylate supplied in vials containing 2 gm of sterile, lyophilized, powdered deferoxamine mesylate. The drug will be reconstituted for injection, by dissolving in 20 ml of sterile water. The reconstituted drug will be further diluted in normal saline to achieve a final concentration of 7.5 mg per ml.~Deferoxamine: Deferoxamine mesylate(62 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset."
11113384|NCT01662895|BG001|Baseline|Normal Saline|"0.9% sodium chloride~Normal saline: This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset."
11113385|NCT01662895|BG002|Baseline|Total|Total of all reporting groups
11113386|NCT01662895|FG000|Participant Flow|Deferoxamine|"Deferoxamine mesylate supplied in vials containing 2 gm of sterile, lyophilized, powdered deferoxamine mesylate. The drug will be reconstituted for injection, by dissolving in 20 ml of sterile water. The reconstituted drug will be further diluted in normal saline to achieve a final concentration of 7.5 mg per ml.~Deferoxamine: Deferoxamine mesylate(62 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset."
11113387|NCT01662895|FG001|Participant Flow|Normal Saline|"0.9% sodium chloride~Normal saline: This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset."
11113388|NCT01662895|OG000|Outcome|Deferoxamine|"Deferoxamine mesylate supplied in vials containing 2 gm of sterile, lyophilized, powdered deferoxamine mesylate. The drug will be reconstituted for injection, by dissolving in 20 ml of sterile water. The reconstituted drug will be further diluted in normal saline to achieve a final concentration of 7.5 mg per ml.~Deferoxamine: Deferoxamine mesylate(62 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset."
11113389|NCT01662895|OG001|Outcome|Normal Saline|"0.9% sodium chloride~Normal saline: This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset."
11113390|NCT01662895|EG000|Reported Event|Deferoxamine|"Deferoxamine mesylate supplied in vials containing 2 gm of sterile, lyophilized, powdered deferoxamine mesylate. The drug will be reconstituted for injection, by dissolving in 20 ml of sterile water. The reconstituted drug will be further diluted in normal saline to achieve a final concentration of 7.5 mg per ml.~Deferoxamine: Deferoxamine mesylate(62 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset."
11113391|NCT01662895|EG001|Reported Event|Normal Saline|"0.9% sodium chloride~Normal saline: This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset."
11113392|NCT01662908|BG000|Baseline|Edoxaban|Participants treated with edoxaban
11113393|NCT01662908|BG001|Baseline|Warfarin|Participants treated with warfarin
11113394|NCT01662908|BG002|Baseline|Total|Total of all reporting groups
11113395|NCT01662908|FG000|Participant Flow|Edoxaban|Participants treated with edoxaban
11113396|NCT01662908|FG001|Participant Flow|Warfarin|Participants treated with warfarin
11113397|NCT01662908|OG000|Outcome|Edoxaban|Participants treated with edoxaban
11113398|NCT01662908|OG001|Outcome|Warfarin|Participants treated with warfarin
11113399|NCT01662908|EG000|Reported Event|Edoxaban|Participants treated with edoxaban
11113400|NCT01662908|EG001|Reported Event|Warfarin|Participants treated with warfarin
11113401|NCT01662960|BG000|Baseline|Mirror Therapy: High Functioning|"4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.~High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50."
11113402|NCT01662960|BG001|Baseline|Mirror Therapy: Low Functioning|"4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.~Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29."
11113403|NCT01662960|BG002|Baseline|Divider Therapy: High Functioning|"4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.~High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50."
11113404|NCT01662960|BG003|Baseline|Divider Therapy: Low Functioning|"4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.~Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29."
11113405|NCT01662960|BG004|Baseline|Total|Total of all reporting groups
11126714|NCT01734902|OG001|Outcome|Buscopan® Tablet (R)|Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.
11113406|NCT01662960|FG000|Participant Flow|Mirror Therapy: High Functioning|"4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.~High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50."
11113407|NCT01662960|FG001|Participant Flow|Mirror Therapy: Low Functioning|"4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.~Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29."
11113408|NCT01662960|FG002|Participant Flow|Divider Therapy: High Functioning|"4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.~High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50."
11113409|NCT01662960|FG003|Participant Flow|Divider Therapy: Low Functioning|"4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.~Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29."
11113410|NCT01662960|OG000|Outcome|Mirror Therapy: High Functioning|"4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.~High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50."
11113411|NCT01662960|OG001|Outcome|Mirror Therapy: Low Functioning|"4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.~Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29."
11113412|NCT01662960|OG002|Outcome|Divider Therapy: High Functioning|"4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.~High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50."
11113413|NCT01662960|OG003|Outcome|Divider Therapy: Low Functioning|"4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.~Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29."
11113414|NCT01662960|EG000|Reported Event|Mirror Therapy: High Functioning|"4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.~High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50."
11113415|NCT01662960|EG001|Reported Event|Mirror Therapy: Low Functioning|"4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.~Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29."
11113416|NCT01662960|EG002|Reported Event|Divider Therapy: High Functioning|"4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.~High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50."
11113417|NCT01662960|EG003|Reported Event|Divider Therapy: Low Functioning|"4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.~Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29."
11113418|NCT01662986|BG000|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
11113419|NCT01662986|BG001|Baseline|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler
11113420|NCT01662986|BG002|Baseline|Total|Total of all reporting groups
11113421|NCT01662986|FG000|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
11113422|NCT01662986|FG001|Participant Flow|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler
11113423|NCT01662986|OG000|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
11113424|NCT01662986|OG001|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler
11113425|NCT01662986|EG000|Reported Event|Placebo|Patient to receive one placebo inhalation powder capsule once daily in the morning via HandiHaler
11113426|NCT01662986|EG001|Reported Event|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler
11113427|NCT01662999|BG000|Baseline|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
11113428|NCT01662999|BG001|Baseline|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
11113429|NCT01662999|BG002|Baseline|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
11113430|NCT01662999|BG003|Baseline|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
11113431|NCT01662999|BG004|Baseline|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
11113432|NCT01662999|BG005|Baseline|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
11113433|NCT01662999|BG006|Baseline|Total|Total of all reporting groups
11113434|NCT01662999|FG000|Participant Flow|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|"Single dose of:~Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
11113435|NCT01662999|FG001|Participant Flow|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|"Single dose of:~Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
11113436|NCT01662999|FG002|Participant Flow|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|"Single dose of:~Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
11113437|NCT01662999|FG003|Participant Flow|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|"Single dose of:~Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral"
11113438|NCT01662999|FG004|Participant Flow|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|"Single dose of:~Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
11113439|NCT01662999|FG005|Participant Flow|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|"Single dose of:~Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet"
11113440|NCT01662999|OG000|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
11113441|NCT01662999|OG001|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
11113442|NCT01662999|OG000|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
11113443|NCT01662999|OG000|Outcome|10mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
11113444|NCT01662999|OG000|Outcome|5 mg Saxagliptin|Treatment A: Single dose Saxagliptin 5mg, Tablet, Oral.
11113445|NCT01662999|OG000|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
11113446|NCT01662999|OG000|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
11113447|NCT01662999|OG000|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
11113448|NCT01662999|OG000|Outcome|5 mg Saxagliptin|Treatment A: Single saxagliptin 5mg, Tablet, Oral.
11113449|NCT01662999|OG001|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
11113450|NCT01662999|OG000|Outcome|Treatment A: Saxagliptin 5mg|Treatment A: Single dose oral tablet of 5 mg saxagliptin..
11113451|NCT01662999|OG001|Outcome|Treatment B: Dapagliflozin 10mg|Treatment B: A single oral tablet dose of 10 mg Dapagliflozin.
11113452|NCT01662999|OG002|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin..
11113453|NCT01662999|OG000|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
11113454|NCT01662999|OG001|Outcome|Treatment B: Dapagliflozin 10mg|A single oral tablet dose of 10 mg Dapagliflozin.
11113455|NCT01662999|OG002|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
11113456|NCT01662999|OG001|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
11113457|NCT01662999|OG001|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
11113458|NCT01662999|OG002|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
11113459|NCT01662999|OG000|Outcome|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
11113460|NCT01662999|OG001|Outcome|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
11113461|NCT01662999|OG002|Outcome|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
11113462|NCT01662999|OG003|Outcome|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
11113463|NCT01662999|OG004|Outcome|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
11113464|NCT01662999|OG005|Outcome|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
11113465|NCT01662999|EG000|Reported Event|Treatment A: Saxagliptin 5mg|Saxagliptin 5mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
11113466|NCT01662999|EG001|Reported Event|Treatment B: Dapagliflozin 10mg|Dapagliflozin 10mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
11113467|NCT01662999|EG002|Reported Event|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, Once daily, 1 day in each of 3 periods.
11126715|NCT01734902|EG000|Reported Event|Hyoscine Butylbromide Drops (T)|Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.
11126716|NCT01734902|EG001|Reported Event|Buscopan® Tablet (R)|Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.
11113468|NCT01663012|BG000|Baseline|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
11113469|NCT01663012|FG000|Participant Flow|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
11113470|NCT01663012|OG000|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
11113471|NCT01663012|EG000|Reported Event|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
11113472|NCT01663103|BG000|Baseline|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
11113473|NCT01663103|BG001|Baseline|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
11113474|NCT01663103|BG002|Baseline|Total|Total of all reporting groups
11113475|NCT01663103|FG000|Participant Flow|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
11113476|NCT01663103|FG001|Participant Flow|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
11113477|NCT01663103|OG000|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
11113478|NCT01663103|OG001|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
11113479|NCT01663103|OG000|Outcome|Rilonacept: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at baseline.
11113480|NCT01663103|OG001|Outcome|Rilonacept: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at 12 weeks.
11113481|NCT01663103|OG002|Outcome|Placebo: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
11113482|NCT01663103|OG003|Outcome|Placebo: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
11113483|NCT01663103|EG000|Reported Event|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
11113484|NCT01663103|EG001|Reported Event|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
11113485|NCT01663233|BG000|Baseline|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
11113486|NCT01663233|BG001|Baseline|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
11113487|NCT01663233|BG002|Baseline|Total|Total of all reporting groups
11113488|NCT01663233|FG000|Participant Flow|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
11113489|NCT01663233|FG001|Participant Flow|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
11113490|NCT01663233|OG000|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
11113491|NCT01663233|OG001|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
11113492|NCT01663233|EG000|Reported Event|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
11113493|NCT01663233|EG001|Reported Event|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
11113494|NCT01663259|BG000|Baseline|Cetuximab + Radiotherapy|Patients received a single loading dose public) of cetuximab 400 mg/m (Day 0), then weekly cetuximab 250 mg/m concurrent with radiation. Within approximately 4 days after first (loading) dose of cetuximab, patients received radiation administered as 70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes.
11113495|NCT01663259|FG000|Participant Flow|Cetuximab + Radiotherapy|Patients received a single loading dose public) of cetuximab 400 mg/m (Day 0), then weekly cetuximab 250 mg/m concurrent with radiation. Within approximately 4 days after first (loading) dose of cetuximab, patients received radiation administered as 70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes.
11113496|NCT01663259|OG000|Outcome|Cetuximab + Radiotherapy|Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
11113497|NCT01663259|EG000|Reported Event|Cetuximab|Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
11113498|NCT01663272|BG000|Baseline|Cabozantinib With Gemcitabine|Patients received daily oral cabozantinib, at 20mg or 40mg, administered days -7 until disease progression, intolerable adverse event(s) or patient choice AND Gemcitabine at 800mg/m^2 or 1000mg/m^2 administered intravenously on days 1, 8, and 15 every 28 days.
11113499|NCT01663272|FG000|Participant Flow|Dose Level -1|"20 mg of cabozantinib PO daily administered days -7 until disease progression, intolerable adverse event(s) or patient choice.~800mg/m^2 of gemcitabine administered intravenously on days 1, 8, and 15 every 28 days."
11113500|NCT01663272|FG001|Participant Flow|Dose Level 1|"20 mg of cabozantinib PO daily administered days -7 until disease progression, intolerable adverse event(s) or patient choice.~1000mg/m^2 of gemcitabine administered intravenously on days 1, 8, and 15 every 28 days."
11113501|NCT01663272|FG002|Participant Flow|Dose Level 2|"40 mg of cabozantinib PO daily administered days -7 until disease progression, intolerable adverse event(s) or patient choice.~1000mg/m^2 of gemcitabine administered intravenously on days 1, 8, and 15 every 28 days."
11113502|NCT01663272|OG000|Outcome|Cabozantinib With Gemcitabine|"The Study Treatment Period will consist of continued treatment during which time patients will receive cabozantinib and gemcitabine until either disease progression or the occurrence of unacceptable drug-related toxicity~Cabozantinib: Daily oral cabozantinib (20mg OR 40mg) administered days -7 until disease progression, intolerable adverse event(s) or patient choice.~Gemcitabine: Gemcitabine (800mg/m^2 OR 1000mg/m^2) administered intravenously on days 1, 8, and 15 every 28 days."
11113503|NCT01663272|EG000|Reported Event|Cabozantinib With Gemcitabine|Adverse events were pooled for all treated patients and were not collected by dose level. Patients received daily oral cabozantinib, at 20mg or 40mg, administered days -7 until disease progression, intolerable adverse event(s) or patient choice AND Gemcitabine at 800mg/m^2 or 1000mg/m^2 administered intravenously on days 1, 8, and 15 every 28 days.
11113504|NCT01663363|BG000|Baseline|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
11113505|NCT01663363|FG000|Participant Flow|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
11113506|NCT01663363|OG000|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
11113507|NCT01663363|EG000|Reported Event|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
11113508|NCT01663402|BG000|Baseline|Placebo|Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.
11113509|NCT01663402|BG001|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).
11113510|NCT01663402|BG002|Baseline|Total|Total of all reporting groups
11113511|NCT01663402|FG000|Participant Flow|Placebo|Placebo (for alirocumab) SC injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.
11113512|NCT01663402|FG001|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).
11113513|NCT01663402|OG000|Outcome|Placebo|Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.
11113514|NCT01663402|OG001|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).
11113515|NCT01663402|EG000|Reported Event|Placebo|Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.
11113516|NCT01663402|EG001|Reported Event|Alirocumab|Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).
11113517|NCT01663506|BG000|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
11113518|NCT01663506|FG000|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
11113519|NCT01663506|OG000|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
11113520|NCT01663506|EG000|Reported Event|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
11113521|NCT01663532|BG000|Baseline|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
11113522|NCT01663532|BG001|Baseline|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
11113523|NCT01663532|BG002|Baseline|Total|Total of all reporting groups
11113524|NCT01663532|FG000|Participant Flow|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
11113525|NCT01663532|FG001|Participant Flow|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
11113526|NCT01663532|OG000|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
11113527|NCT01663532|OG001|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
11113528|NCT01663532|EG000|Reported Event|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
11113529|NCT01663532|EG001|Reported Event|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
11113530|NCT01663623|BG000|Baseline|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
11113531|NCT01663623|BG001|Baseline|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
11113532|NCT01663623|BG002|Baseline|Total|Total of all reporting groups
11113533|NCT01663623|FG000|Participant Flow|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
11113534|NCT01663623|FG001|Participant Flow|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
11113535|NCT01663623|OG000|Outcome|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
11113536|NCT01663623|OG001|Outcome|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
11113537|NCT01663623|EG000|Reported Event|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
11113538|NCT01663623|EG001|Reported Event|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
11113539|NCT01663636|BG000|Baseline|SMS Vaccine|Mothers will be sent an SMS message reminding them to come for their scheduled vaccines 1 week prior to the date of 2nd and 3rd doses
11113540|NCT01663636|BG001|Baseline|Usual Care|Mothers under usual care will serve as a control
11113541|NCT01663636|BG002|Baseline|Total|Total of all reporting groups
11113542|NCT01663636|FG000|Participant Flow|SMS Vaccine|Parent or guardian will be sent an SMS message reminding them to bring in their infant(s) for the infant(s) scheduled vaccines 1 week prior to the date of 2nd and 3rd doses.
11113543|NCT01663636|FG001|Participant Flow|Usual Care|Parent or guardian and their infants who are under usual care (no SMS) will serve as a control group.
11113544|NCT01663636|OG000|Outcome|SMS Vaccine|Mothers will be sent an SMS message reminding them to come for their scheduled vaccines 1 week prior to the date of 2nd and 3rd doses
11113545|NCT01663636|OG001|Outcome|Usual Care|Mothers under usual care will serve as a control
11113546|NCT01663636|EG000|Reported Event|SMS Vaccine|Mothers will be sent an SMS message reminding them to come for their scheduled vaccines 1 week prior to the date of 2nd and 3rd doses
11113547|NCT01663636|EG001|Reported Event|Usual Care|Mothers under usual care will serve as a control
11113548|NCT01663714|BG000|Baseline|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
11113549|NCT01663714|FG000|Participant Flow|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared [mg/m^2]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
11113550|NCT01663714|OG000|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
11113551|NCT01663714|EG000|Reported Event|Period After CVP|Par. received 6 cycles of chemotherapy as follows: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; intravenous Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days
11113552|NCT01663714|EG001|Reported Event|Period After Dosimetric and Therapeutic Dose|After receiving Cyclophosphamide, Vincristine, and Prednisone, par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose.
11113553|NCT01663714|EG002|Reported Event|Combined Regimen Period|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
11113554|NCT01663727|BG000|Baseline|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
11113555|NCT01663727|BG001|Baseline|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
11113556|NCT01663727|BG002|Baseline|Total|Total of all reporting groups
11113557|NCT01663727|FG000|Participant Flow|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
11113558|NCT01663727|FG001|Participant Flow|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
11113559|NCT01663727|OG000|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
11113560|NCT01663727|OG001|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
11113561|NCT01663727|EG000|Reported Event|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
11113562|NCT01663727|EG001|Reported Event|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
11113563|NCT01663740|BG000|Baseline|Cohort A: Partcipants Who Received Valganciclovir|Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
11113564|NCT01663740|BG001|Baseline|Cohort B: Untreated Participants|Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
10846052|NCT00272779|FG001|Participant Flow|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
11113565|NCT01663740|BG002|Baseline|Total|Total of all reporting groups
11113566|NCT01663740|FG000|Participant Flow|Cohort A: Partcipants Who Received Valganciclovir|Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
11113567|NCT01663740|FG001|Participant Flow|Cohort B: Untreated Participants|Participants with donor negative (D-)/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
11113568|NCT01663740|OG000|Outcome|Cohort A: Partcipants Who Received Valganciclovir|Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
11113569|NCT01663740|OG001|Outcome|Cohort B: Untreated Participants|Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
11113570|NCT01663740|EG000|Reported Event|Cohort A: Partcipants Who Received Valganciclovir|Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
11113571|NCT01663740|EG001|Reported Event|Cohort B: Untreated Participants|Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
11113572|NCT01663779|BG000|Baseline|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.~Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
11113573|NCT01663779|BG001|Baseline|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization~Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
11113574|NCT01663779|BG002|Baseline|Total|Total of all reporting groups
11113575|NCT01663779|FG000|Participant Flow|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.~Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
11113576|NCT01663779|FG001|Participant Flow|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization~Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
11113577|NCT01663779|OG000|Outcome|Ultrasound|ultrasound atery
11113578|NCT01663779|OG001|Outcome|Palpation|palpation artery
11113579|NCT01663779|EG000|Reported Event|Ultrasound|ultrasound artery
11113580|NCT01663779|EG001|Reported Event|Palpation|palpation artery
11113581|NCT01663857|BG000|Baseline|Phase 1b: Cohort 1: LY2228820 +Gemcitabine+Carboplatin|"Cohort 1:LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6).~Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10.~Carboplatin area under the concentration curve administered intravenously (IV) over 30 minutes (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3.~Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6)."
11113582|NCT01663857|BG001|Baseline|Phase 1b: Cohort 2: LY2228820 +Gemcitabine+Carboplatin|"Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6).~Gemcitabine 1000 mg/m2 administered IV over 30 min on Days 3 and 10.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.~Cohort 2:LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)."
11113583|NCT01663857|BG002|Baseline|Arm A: LY2228820 + Gemcitabine + Carboplatin|"Arm A:LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6).~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.~Arm A:LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)."
11113584|NCT01663857|BG003|Baseline|Arm B Placebo + Gemcitabine +Carboplatin|"Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle (Cycles 1-6).~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.~Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)."
11113585|NCT01663857|BG004|Baseline|Total|Total of all reporting groups
11113586|NCT01663857|FG000|Participant Flow|Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin|"Cohort 1:LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6).~Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10 of a 21-day cycle.~Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.~Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)."
11113587|NCT01663857|FG001|Participant Flow|Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin|"Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10 of a 21-day cycle.~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.~Cohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)."
11113588|NCT01663857|FG002|Participant Flow|Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin|"Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.~Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113589|NCT01663857|FG003|Participant Flow|Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin|"Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.~Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113590|NCT01663857|OG000|Outcome|LY2228820 + Gemcitabine + Carboplatin|"Cohort 1 : LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)~Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10~Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3~Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3~Cohort 1 and 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113591|NCT01663857|OG000|Outcome|LY2228820 + Gemcitabine +Carboplatin|"Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of 21-day cycles.~Gemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of 21-day cycles.~Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)"
11113592|NCT01663857|OG001|Outcome|Placebo + Gemcitabine + Carboplatin|"Arm B: Placebo orally every 12 hrs. on Days 1-10 of 21-day cycles.~Gemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. n Day 3 of 21-day cycles.~Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)"
11113593|NCT01663857|OG000|Outcome|LY2228820 + Gemcitabine +Carboplatin|"Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.~Gemcitabine 1000 mg/m2 IV over 30 min.(+ 15 min.) on Days 3 and 10 of a 21-day cycle.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day.~Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)."
11113594|NCT01663857|OG001|Outcome|Placebo + Gemcitabine + Carboplatin|"Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.~Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)"
11113595|NCT01663857|OG000|Outcome|LY2228820 + Gemcitabine +Carboplatin|"Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day.~Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)."
11113596|NCT01663857|OG000|Outcome|200 mg LY2228820|"Phase 1b (Cohort 1) and Phase 2 (Arm A): LY2228820 200 mg administered orally every 12 hours on Days 1-10, Cycles 1-6 of a 21 day cycle.~."
11113597|NCT01663857|OG001|Outcome|300 mg LY2228820|Phase 1b (Cohort 2) and Phase 2 (Arm A) in the maintenance portion with LY2228820 300 mg administered orally every 12 hours on Days 1-14 Cycle 7+ of a 28-day cycle.
11113598|NCT01663857|OG000|Outcome|LY2228820 + Gemcitabine +Carboplatin|"Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day.~Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113599|NCT01663857|OG001|Outcome|Placebo + Gemcitabine + Carboplatin|"Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.~Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113600|NCT01663857|EG000|Reported Event|Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin|"Cohort 1: LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)~Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10~Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3~Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113601|NCT01663857|EG001|Reported Event|Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin|"Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3~Cohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113602|NCT01663857|EG002|Reported Event|Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin|"Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3~Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113603|NCT01663857|EG003|Reported Event|Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin|"Arm B: Placebo orally every 12 hrs. on Days 1-10~Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10~Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3~Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)"
11113604|NCT01663896|BG000|Baseline|Optical Coherence Tomography (OCT)|Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
11113605|NCT01663896|FG000|Participant Flow|Optical Coherence Tomography (OCT)|Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
11113606|NCT01663896|OG000|Outcome|Optical Coherence Tomography (OCT)|A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
11113607|NCT01663896|OG000|Outcome|Optical Coherence Tomography (OCT)|Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
11113608|NCT01663896|EG000|Reported Event|Optical Coherence Tomography (OCT)|Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
11113609|NCT01663922|BG000|Baseline|All Participants|Descriptive analysis of combined groups
11113610|NCT01663922|FG000|Participant Flow|Group A (St John's Wort Then Boceprevir)|"St John's Wort, (SJW) for 14 days (1-14)~[wash out for 7 days (15-21)]~SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)~[wash out for 7 days (36-42)]~boceprevir from day 52 to day 56"
11113611|NCT01663922|FG001|Participant Flow|Group B (Boceprevir Then St John's Wort)|"Boceprevir for 5 days (10-14)~[wash out for 7 days (15-21)]~SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)~[wash out for 7 days (36-42)~SJW from day 43 to day 56"
11113612|NCT01663922|OG000|Outcome|All Participants|Combined analysis of both group sequences
11113613|NCT01663922|EG000|Reported Event|Group A|St John's Wort first
11113614|NCT01663922|EG001|Reported Event|Group B|Boceprevir first
11113615|NCT01663935|BG000|Baseline|Levodopa/Carbidopa 4mg/kg/Day|"Treatment drug taken orally three times daily~Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug."
11113616|NCT01663935|FG000|Participant Flow|Levodopa/Carbidopa 4mg/kg/Day|"Treatment drug taken orally three times daily~Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug."
11113617|NCT01663935|OG000|Outcome|Levodopa/Carbidopa 4mg/kg/Day|"Treatment drug taken orally three times daily~Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug."
11113618|NCT01663935|EG000|Reported Event|Levodopa/Carbidopa 4mg/kg/Day|"Treatment drug taken orally three times daily~Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug."
11113619|NCT01663987|BG000|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
11113620|NCT01663987|BG001|Baseline|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
11113621|NCT01663987|BG002|Baseline|Total|Total of all reporting groups
11113622|NCT01663987|FG000|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
11113623|NCT01663987|FG001|Participant Flow|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
11113624|NCT01663987|OG000|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
11113625|NCT01663987|OG001|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
11113626|NCT01663987|EG000|Reported Event|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
11113627|NCT01663987|EG001|Reported Event|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
11113628|NCT01664039|BG000|Baseline|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
11113629|NCT01664039|BG001|Baseline|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
11113630|NCT01664039|BG002|Baseline|Total|Total of all reporting groups
11113631|NCT01664039|FG000|Participant Flow|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
11113632|NCT01664039|FG001|Participant Flow|LUMIGAN|One drop to the study eye(s) once a day in the evening, for 6 months
11113633|NCT01664039|OG000|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
11113634|NCT01664039|OG001|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
11113635|NCT01664039|EG000|Reported Event|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
11113636|NCT01664039|EG001|Reported Event|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
11113637|NCT01664052|BG000|Baseline|ESS505-A|Bilateral placement of Essure 505A (BAY1454033) insert (with minimal PET fiber).
11113638|NCT01664052|BG001|Baseline|ESS305/ESS505|Unilateral placement of Essure 505 (BAY1454033) insert (PET-inclusive) and Contralateral placement of the current commercial Essure device Essure 305 (BAY1454032)
11113639|NCT01664052|BG002|Baseline|Total|Total of all reporting groups
11113640|NCT01664052|FG000|Participant Flow|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
11113641|NCT01664052|FG001|Participant Flow|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
11113642|NCT01664052|OG000|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
11113643|NCT01664052|OG001|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
11113644|NCT01664052|OG002|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
11113645|NCT01664052|EG000|Reported Event|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
11113646|NCT01664052|EG001|Reported Event|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
11113647|NCT01664078|BG000|Baseline|InCraft® - AAA Stent Graft System|"Intervention: Endovascular AAA repair using the InCraft device~Endovascular AAA repair with InCraft®"
11113648|NCT01664078|FG000|Participant Flow|InCraft® - AAA Stent Graft System|"Intervention: Endovascular AAA repair using the InCraft device~Endovascular AAA repair with InCraft®"
11113649|NCT01664078|OG000|Outcome|InCraft® - AAA Stent Graft System|"Intervention: Endovascular AAA repair using the InCraft device~Endovascular AAA repair with InCraft®"
11113650|NCT01664078|OG000|Outcome|Site-reported Procedure-related AEs Through 1 Month|procedure-related complications were tabulated as secondary safety endpoints
11113651|NCT01664078|OG001|Outcome|Site-reported Procedure-related AEs Through 180 Days|procedure-related complications were tabulated as secondary safety endpoints
11113652|NCT01664078|OG002|Outcome|Site-reported Procedure-related AEs Through 360 Days|procedure-related complications were tabulated as secondary safety endpoints
11113653|NCT01664078|OG003|Outcome|Site-reported Procedure-related AEs Through 2 Years|procedure-related complications were tabulated as secondary safety endpoints
11113654|NCT01664078|OG004|Outcome|Site-reported Procedure-related AEs Through 3 Years|procedure-related complications were tabulated as secondary safety endpoints
11113655|NCT01664078|OG005|Outcome|Site-reported Procedure-related AEs Through 4 Years|procedure-related complications were tabulated as secondary safety endpoints
11113656|NCT01664078|OG006|Outcome|Site-reported Procedure-related AEs Through 5 Years|procedure-related complications were tabulated as secondary safety endpoints
11113657|NCT01664078|OG000|Outcome|Aneurysm-related Morality Through 1 Month|Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.
11113658|NCT01664078|OG001|Outcome|Aneurysm-related Morality Through 180 Days|Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.
11113659|NCT01664078|OG002|Outcome|Aneurysm-related Morality Through 360 Days|Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.
11113660|NCT01664078|OG003|Outcome|Aneurysm-related Morality Through 2 Years|Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.
11113661|NCT01664078|OG004|Outcome|Aneurysm-related Morality Through 3 Years|Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.
11113662|NCT01664078|OG005|Outcome|Aneurysm-related Morality Through 4 Years|Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.
11113663|NCT01664078|OG006|Outcome|Aneurysm-related Morality Through 5 Years|Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.
11113664|NCT01664078|OG000|Outcome|Secondary Intervention Through 1 Month|The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
11113665|NCT01664078|OG001|Outcome|Secondary Intervention Through 180 Days|The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
11113666|NCT01664078|OG002|Outcome|Secondary Intervention Through 360 Days|The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
11113667|NCT01664078|OG003|Outcome|Secondary Intervention Through 2 Years|The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
11113668|NCT01664078|OG004|Outcome|Secondary Intervention Through 3 Years|The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
11113669|NCT01664078|OG005|Outcome|Secondary Intervention Through 4 Years|The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
11113670|NCT01664078|OG006|Outcome|Secondary Intervention Through 5 Years|The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
10846053|NCT00272779|OG000|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
11113671|NCT01664078|OG000|Outcome|MAEs Through 180 Days|All MAEs are site-reported then adjudicated by the CEC.
11113672|NCT01664078|OG001|Outcome|MAEs Through 360 Days|All MAEs are site-reported then adjudicated by the CEC.
11113673|NCT01664078|OG002|Outcome|MAEs Through 2 Years|All MAEs are site-reported then adjudicated by the CEC.
11113674|NCT01664078|OG003|Outcome|MAEs Through 3 Years|All MAEs are site-reported then adjudicated by the CEC.
11113675|NCT01664078|OG004|Outcome|MAEs Through 4 Years|All MAEs are site-reported then adjudicated by the CEC.
11113676|NCT01664078|OG005|Outcome|MAEs Through 5 Years|All MAEs are site-reported then adjudicated by the CEC.
11348288|NCT04189081|FG001|Participant Flow|Experimental Mouth Rinse|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11113677|NCT01664078|OG000|Outcome|Device-related Events Through 1 Month|Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.
11113678|NCT01664078|OG001|Outcome|Device-related Events Through 180 Days|Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.
11113679|NCT01664078|OG002|Outcome|Device-related Events Through 360 Days|Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.
11113680|NCT01664078|OG003|Outcome|Device-related Events Through 2 Years|Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.
11113681|NCT01664078|OG004|Outcome|Device-related Events Through 3 Years|Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.
11113682|NCT01664078|OG005|Outcome|Device-related Events Through 4 Years|Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.
11113683|NCT01664078|OG006|Outcome|Device-related Events Through 5 Years|Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.
11113684|NCT01664078|OG000|Outcome|Technical Success|Technical success confirmed by CT or other imaging modality
11113685|NCT01664078|OG000|Outcome|Length of Hospital Stay (Days) Post Index Procedure|Length of hospital stay (days) post index procedure as part of the clinical utility measure
11113686|NCT01664078|OG000|Outcome|Length of Intensive Care Unit (ICU) Stay (Hours) Post Index pr|Length of Intensive Care Unit (ICU) stay (hours) post index pr as part of the clinical utility measure
11113687|NCT01664078|OG000|Outcome|Length of the Index Procedure (Minutes)|Length of the Index Procedure (Minutes) as part of the clinical utility measure
11113688|NCT01664078|OG000|Outcome|Pain Post-Operatively at Baseline|Pain post-operatively as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up
11113689|NCT01664078|OG001|Outcome|Pain Post-Operatively at 1-Month|Pain post-operatively were compared to baseline values, as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up
11113690|NCT01664078|OG002|Outcome|Pain Post-Operatively at 6-Months|Pain post-operatively were compared to baseline values, as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up
11113691|NCT01664078|OG003|Outcome|Pain Post-Operatively at 1-Year|Pain post-operatively were compared to baseline values, as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up
11113692|NCT01664078|OG000|Outcome|Physical Functioning Post-operatively at Baseline|Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up
11113693|NCT01664078|OG001|Outcome|Physical Functioning Post-operatively at 1 Month|Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up
11113694|NCT01664078|OG002|Outcome|Physical Functioning Post-operatively at 6 Month|Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up
11113695|NCT01664078|OG003|Outcome|Physical Functioning Post-operatively at 1 Year|Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up
11113696|NCT01664078|EG000|Reported Event|InCraft|Infrarenal Abdominal Aortic Aneurysm Stent Graft System
11113697|NCT01664091|BG000|Baseline|Tissue Expander and Acellular Dermal Matrix|"immediate reconstruction with a TE and ADM followed by PMRT~radiation: The prescribed chest-wall dose will be 50 - 50.4 Gy in 25-28 fractions, given once daily over 5-7 weeks."
11126717|NCT01734993|BG000|Baseline|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
11113698|NCT01664091|FG000|Participant Flow|TE-ADM With PMRT|Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.
11113699|NCT01664091|OG000|Outcome|TE-ADM With PMRT|Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT.
11113700|NCT01664091|OG000|Outcome|TE-ADM With PMRT|Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.
11113701|NCT01664091|EG000|Reported Event|TE-ADM With PMRT|Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.
11113702|NCT01664104|BG000|Baseline|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
11113703|NCT01664104|FG000|Participant Flow|Rheumatoid Arthritis (RA) Participants|Participants with moderate or severe RA who were under tocilizumab (TCZ) treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
11113704|NCT01664104|OG000|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
11113705|NCT01664104|OG000|Outcome|RA Participants|Participants with moderate or severe RA were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.
11113706|NCT01664104|OG000|Outcome|RA Participants|Participants with moderate or severe RA who were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.
11113707|NCT01664104|EG000|Reported Event|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
11113708|NCT01664117|BG000|Baseline|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
11113709|NCT01664117|FG000|Participant Flow|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
11113710|NCT01664117|OG000|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
11113711|NCT01664117|OG000|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
11113712|NCT01664117|OG000|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
11113713|NCT01664117|OG001|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
11113714|NCT01664117|EG000|Reported Event|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
11113715|NCT01664130|BG000|Baseline|Treatment (SBRT)|"Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.~stereotactic body radiation therapy: Undergo SBRT~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11113716|NCT01664130|FG000|Participant Flow|Treatment (SBRT)|"Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.~stereotactic body radiation therapy: Undergo SBRT~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11113717|NCT01664130|OG000|Outcome|Treatment (SBRT)|"Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.~stereotactic body radiation therapy: Undergo SBRT~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11113718|NCT01664130|OG000|Outcome|Baseline|Before treatment
11113719|NCT01664130|OG001|Outcome|After Treatment (SBRT)|"After treatment (SBRT)~Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.~stereotactic body radiation therapy: Undergo SBRT~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11113720|NCT01664130|OG000|Outcome|Baseline|Before treatment.
11113721|NCT01664130|EG000|Reported Event|Treatment (SBRT)|"Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.~stereotactic body radiation therapy: Undergo SBRT~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11113722|NCT01664247|BG000|Baseline|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
11113723|NCT01664247|BG001|Baseline|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject's choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
11113724|NCT01664247|BG002|Baseline|Total|Total of all reporting groups
11113725|NCT01664247|FG000|Participant Flow|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
11113726|NCT01664247|FG001|Participant Flow|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject's choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
11113727|NCT01664247|OG000|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
11113728|NCT01664247|OG001|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject's choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
11113729|NCT01664247|EG000|Reported Event|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
11113730|NCT01664247|EG001|Reported Event|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject's choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
11113731|NCT01664494|BG000|Baseline|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
11113732|NCT01664494|FG000|Participant Flow|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
11113733|NCT01664494|OG000|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
11113734|NCT01664494|EG000|Reported Event|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
11113735|NCT01664533|BG000|Baseline|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
11113736|NCT01664533|FG000|Participant Flow|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
11113737|NCT01664533|OG000|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
11113738|NCT01664533|OG000|Outcome|Erlotinib|"Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.~Erlotinib: Erlotinib was supplied as tablets in the retail product Tarceva."
11113739|NCT01664533|EG000|Reported Event|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
11113740|NCT01664559|BG000|Baseline|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
11113741|NCT01664559|BG001|Baseline|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
11113742|NCT01664559|BG002|Baseline|Total|Total of all reporting groups
11113743|NCT01664559|FG000|Participant Flow|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
11113744|NCT01664559|FG001|Participant Flow|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
11113745|NCT01664559|OG000|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
11113746|NCT01664559|OG001|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
11113747|NCT01664559|EG000|Reported Event|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
11113748|NCT01664559|EG001|Reported Event|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
11113749|NCT01664624|BG000|Baseline|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
11113750|NCT01664624|BG001|Baseline|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
11113751|NCT01664624|BG002|Baseline|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
11113752|NCT01664624|BG003|Baseline|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
11113753|NCT01664624|BG004|Baseline|Total|Total of all reporting groups
11113754|NCT01664624|FG000|Participant Flow|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
11113755|NCT01664624|FG001|Participant Flow|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
11113756|NCT01664624|FG002|Participant Flow|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
11113757|NCT01664624|FG003|Participant Flow|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
11113758|NCT01664624|OG000|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
11113759|NCT01664624|OG001|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
11113760|NCT01664624|OG002|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
11113761|NCT01664624|OG003|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
11113762|NCT01664624|EG000|Reported Event|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
11113763|NCT01664624|EG001|Reported Event|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
11113764|NCT01664624|EG002|Reported Event|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
11113765|NCT01664624|EG003|Reported Event|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
11113766|NCT01664741|BG000|Baseline|Nicotine Patch - Transdermal|"21 mg nicotine patch~Nicotine patch - transdermal"
11113767|NCT01664741|BG001|Baseline|Placebo NRT|"Matching placebo patch~placebo"
11113768|NCT01664741|BG002|Baseline|Healthy Non-smoker Comparison|Demographically-matched women and men who have never smoked
11113769|NCT01664741|BG003|Baseline|Total|Total of all reporting groups
11113770|NCT01664741|FG000|Participant Flow|Nicotine Patch - Transdermal|"21 mg nicotine patch~Nicotine patch - transdermal"
11113771|NCT01664741|FG001|Participant Flow|Placebo NRT|"Matching placebo patch~placebo"
11113772|NCT01664741|FG002|Participant Flow|Healthy Non-smoker Comparison|Demographically-matched women and men who have never smoked
11113773|NCT01664741|OG000|Outcome|Nicotine Patch - Transdermal|"21 mg nicotine patch~Nicotine patch - transdermal"
11113774|NCT01664741|OG001|Outcome|Placebo NRT|"Matching placebo patch~placebo"
11113775|NCT01664741|OG002|Outcome|Healthy Non-smoker Comparison|Demographically-matched women and men who have never smoked
11113776|NCT01664741|EG000|Reported Event|Nicotine Patch - Transdermal|"21 mg nicotine patch~Nicotine patch - transdermal"
11113777|NCT01664741|EG001|Reported Event|Placebo NRT|"Matching placebo patch~placebo"
11113778|NCT01664793|BG000|Baseline|Intervention Group|Children in 10 diverse pediatric and family medicine practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
11113779|NCT01664793|BG001|Baseline|Control Group|Children in 10 diverse pediatric and family practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
11113780|NCT01664793|BG002|Baseline|Total|Total of all reporting groups
11113781|NCT01664793|FG000|Participant Flow|Intervention Group|"Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the Intervention group; n=49,039.~Intervention sites will use the 4 Pillars toolkit along with early season vaccine to promote increases in childhood influenza vaccination."
11113782|NCT01664793|FG001|Participant Flow|Control Group|Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the control group; n=38,626. They will receive the 4 Pillars Toolkit and early season vaccine in Year 2.
11113783|NCT01664793|OG000|Outcome|Intervention Group|Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.
11113784|NCT01664793|OG001|Outcome|Control Group|Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.
11113785|NCT01664793|OG000|Outcome|Intervention Group|2 respondents in each of 10 diverse pediatric and family medicine practices.
11113786|NCT01664793|OG001|Outcome|Control Group|This group did not rate effectiveness of the intervention.
11113787|NCT01664793|EG000|Reported Event|Intervention Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
11113788|NCT01664793|EG001|Reported Event|Control Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
11113789|NCT01664806|BG000|Baseline|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
11113790|NCT01664806|BG001|Baseline|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
11113791|NCT01664806|BG002|Baseline|Total|Total of all reporting groups
11113792|NCT01664806|FG000|Participant Flow|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
11113793|NCT01664806|FG001|Participant Flow|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
11113794|NCT01664806|OG000|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
11113795|NCT01664806|OG001|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
11113796|NCT01664806|EG000|Reported Event|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
11113797|NCT01664806|EG001|Reported Event|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
11113798|NCT01664858|BG000|Baseline|3T CMR-guided Management|"Patient to be managed according to the results of 3T CMR imaging~3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging~X-Ray coronary angiography: X-Ray coronary angiography~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test ."
11113799|NCT01664858|BG001|Baseline|SPECT-guided Management|"Patients to be managed according to the results of SPECT~SPECT: SPECT: Single Photon Emission Computed Tomography~X-Ray coronary angiography: X-Ray coronary angiography~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test ."
11113800|NCT01664858|BG002|Baseline|NICE-guidelines Based Management|"Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.~10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography~SPECT: SPECT: Single Photon Emission Computed Tomography~CT calcium score: CT calcium score~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .~CT coronary angiography: CT coronary angiography~X-Ray coronary angiography: X-Ray coronary angiography"
11113801|NCT01664858|BG003|Baseline|Total|Total of all reporting groups
11113802|NCT01664858|FG000|Participant Flow|3T CMR-guided Management|"Patient to be managed according to the results of 3T CMR imaging~3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging~X-Ray coronary angiography: X-Ray coronary angiography"
11113803|NCT01664858|FG001|Participant Flow|SPECT-guided Management|"Patients to be managed according to the results of SPECT~SPECT: SPECT: Single Photon Emission Computed Tomography~X-Ray coronary angiography: X-Ray coronary angiography"
11113804|NCT01664858|FG002|Participant Flow|NICE-guidelines Based Management|"Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.~10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography~SPECT: SPECT: Single Photon Emission Computed Tomography~CT calcium score: CT calcium score~CT coronary angiography: CT coronary angiography~X-Ray coronary angiography: X-Ray coronary angiography"
11113805|NCT01664858|OG000|Outcome|3T CMR-guided Management|"Patient to be managed according to the results of 3T CMR imaging~3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging~X-Ray coronary angiography: X-Ray coronary angiography~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test ."
11113806|NCT01664858|OG001|Outcome|SPECT-guided Management|"Patients to be managed according to the results of SPECT~SPECT: SPECT: Single Photon Emission Computed Tomography~X-Ray coronary angiography: X-Ray coronary angiography~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test ."
11113807|NCT01664858|OG002|Outcome|NICE-guidelines Based Management|"Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.~10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography~SPECT: SPECT: Single Photon Emission Computed Tomography~CT calcium score: CT calcium score~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .~CT coronary angiography: CT coronary angiography~X-Ray coronary angiography: X-Ray coronary angiography"
10878619|NCT00453362|EG000|Reported Event|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~After 14 days and after 56 days of treatment with Erlotinib, participants underwent FDG-PET and FLT-PET scans. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi."
11113808|NCT01664858|OG000|Outcome|3T CMR-guided Management|"Patient to be managed according to the results of 3T CMR imaging~3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging~X-Ray coronary angiography: X-Ray coronary angiography"
11113809|NCT01664858|OG001|Outcome|SPECT-guided Management|"Patients to be managed according to the results of SPECT~SPECT: SPECT: Single Photon Emission Computed Tomography~X-Ray coronary angiography: X-Ray coronary angiography"
11113810|NCT01664858|OG002|Outcome|NICE-guidelines Based Management|"Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.~10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography~SPECT: SPECT: Single Photon Emission Computed Tomography~CT calcium score: CT calcium score~CT coronary angiography: CT coronary angiography~X-Ray coronary angiography: X-Ray coronary angiography"
11113811|NCT01664858|EG000|Reported Event|3T CMR-guided Management|"Patient to be managed according to the results of 3T CMR imaging~3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging~X-Ray coronary angiography: X-Ray coronary angiography~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test ."
11113812|NCT01664858|EG001|Reported Event|SPECT-guided Management|"Patients to be managed according to the results of SPECT~SPECT: SPECT: Single Photon Emission Computed Tomography~X-Ray coronary angiography: X-Ray coronary angiography~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test ."
11113813|NCT01664858|EG002|Reported Event|NICE-guidelines Based Management|"Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.~10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography~SPECT: SPECT: Single Photon Emission Computed Tomography~CT calcium score: CT calcium score~Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .~CT coronary angiography: CT coronary angiography~X-Ray coronary angiography: X-Ray coronary angiography"
11113814|NCT01664897|BG000|Baseline|Treatment (Erlotinib Hydrochloride)|"Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11113815|NCT01664897|FG000|Participant Flow|Treatment (Erlotinib Hydrochloride)|"Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11113816|NCT01664897|OG000|Outcome|Treatment (Erlotinib Hydrochloride)|"Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11113817|NCT01664897|EG000|Reported Event|Treatment (Erlotinib Hydrochloride)|"Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11113818|NCT01664923|BG000|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.
11113819|NCT01664923|BG001|Baseline|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.
11113820|NCT01664923|BG002|Baseline|Total|Total of all reporting groups
11113821|NCT01664923|FG000|Participant Flow|Enzalutamide|Participants received enzalutamide 160 milligram (mg), self-administered as four 40-mg capsules, and 1 bicalutamide matching placebo capsule once per day, by mouth for up to 29 months in double blind (DB) phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules once per day by mouth for up to 36 months in open label phase.
11113822|NCT01664923|FG001|Participant Flow|Bicalutamide Then Enzalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide matching placebo capsules for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth for up to 36 months in open label phase.
11113823|NCT01664923|OG000|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.
11113824|NCT01664923|OG001|Outcome|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.
11113825|NCT01664923|OG000|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, and 1 bicalutamide matching placebo capsule once per day, by mouth for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules once per day by mouth for up to 36 months in open label phase.
11113826|NCT01664923|OG001|Outcome|DB Phase: Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide matching placebo capsules for up to 29 months in DB phase.
11113827|NCT01664923|OG002|Outcome|Open Label Phase: Bicalutamide Crossover to Enzalutamide|Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.
11113828|NCT01664923|EG000|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received same treatment for up to 36 months in open label phase.
11113829|NCT01664923|EG001|Reported Event|DB Phase: Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules for up to 29 months in DB phase.
11113830|NCT01664923|EG002|Reported Event|Open Label Phase: Bicalutamide Crossover to Enzalutamide|Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.
11113831|NCT01664949|BG000|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
11113832|NCT01664949|BG001|Baseline|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
11113833|NCT01664949|BG002|Baseline|Total|Total of all reporting groups
11113834|NCT01664949|FG000|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
11113835|NCT01664949|FG001|Participant Flow|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
11113836|NCT01664949|OG000|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
11113837|NCT01664949|OG001|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
11113838|NCT01664949|EG000|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
11113839|NCT01664949|EG001|Reported Event|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
11113840|NCT01664975|BG000|Baseline|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
11113841|NCT01664975|BG001|Baseline|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
11113842|NCT01664975|BG002|Baseline|Total|Total of all reporting groups
11113843|NCT01664975|FG000|Participant Flow|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
11113844|NCT01664975|FG001|Participant Flow|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
11113845|NCT01664975|OG000|Outcome|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
11113846|NCT01664975|OG001|Outcome|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
11113847|NCT01664975|EG000|Reported Event|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
11113848|NCT01664975|EG001|Reported Event|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
11113849|NCT01665040|BG000|Baseline|Neurostimulation for Chronic Pain|"Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.~Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial.~Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan."
11113850|NCT01665040|FG000|Participant Flow|Neurostimulation for Chronic Pain|"Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.~Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial.~Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan."
11113851|NCT01665040|OG000|Outcome|Neurostimulation for Chronic Pain|"Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.~Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial.~Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan."
11113852|NCT01665040|EG000|Reported Event|Neurostimulation for Chronic Pain|"Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.~Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial.~Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan."
11113853|NCT01665053|BG000|Baseline|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
11113854|NCT01665053|BG001|Baseline|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
11113855|NCT01665053|BG002|Baseline|Total|Total of all reporting groups
11113856|NCT01665053|FG000|Participant Flow|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
11113857|NCT01665053|FG001|Participant Flow|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
11113858|NCT01665053|OG000|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
11113859|NCT01665053|OG001|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
11113860|NCT01665053|EG000|Reported Event|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
11113861|NCT01665053|EG001|Reported Event|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
11113862|NCT01665092|BG000|Baseline|Control|"Normal saline~placebo"
11113863|NCT01665092|BG001|Baseline|Carnitine Low|"Levo-Carnitine 6g~Levo-Carnitine"
11113864|NCT01665092|BG002|Baseline|Carnitine Medium|"Levo-Carnitine 12 g~Levo-Carnitine"
11113865|NCT01665092|BG003|Baseline|Carnitine High|"Levo-Carnitine 18 g~Levo-Carnitine"
11113866|NCT01665092|BG004|Baseline|Total|Total of all reporting groups
11113867|NCT01665092|FG000|Participant Flow|Control|"Normal saline~placebo"
11113868|NCT01665092|FG001|Participant Flow|Carnitine Low|"Levo-Carnitine 6g~Levo-Carnitine"
11113869|NCT01665092|FG002|Participant Flow|Carnitine Medium|"Levo-Carnitine 12 g~Levo-Carnitine"
11113870|NCT01665092|FG003|Participant Flow|Carnitine High|"Levo-Carnitine 18 g~Levo-Carnitine"
11113871|NCT01665092|OG000|Outcome|Control|"Normal saline~placebo"
11113872|NCT01665092|OG001|Outcome|Carnitine Low|"Levo-Carnitine 6g~Levo-Carnitine"
11113873|NCT01665092|OG002|Outcome|Carnitine Medium|"Levo-Carnitine 12 g~Levo-Carnitine"
11113874|NCT01665092|OG003|Outcome|Carnitine High|"Levo-Carnitine 18 g~Levo-Carnitine"
11113875|NCT01665092|EG000|Reported Event|Control|"Normal saline~placebo"
11113876|NCT01665092|EG001|Reported Event|Carnitine Low|"Levo-Carnitine 6g~Levo-Carnitine"
11113877|NCT01665092|EG002|Reported Event|Carnitine Medium|"Levo-Carnitine 12 g~Levo-Carnitine"
11113878|NCT01665092|EG003|Reported Event|Carnitine High|"Levo-Carnitine 18 g~Levo-Carnitine"
11113879|NCT01665157|BG000|Baseline|Low-residue Diet Package (Enimaclin®) and 2L PEG|Low-residue diet package with normal amount of 2L PEG-ELS
10846054|NCT00272779|OG001|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
11113880|NCT01665157|BG001|Baseline|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount of 2L PEG-ELS
11113881|NCT01665157|BG002|Baseline|Low-residue Diet (Enimaclin®) Package and 1.5L PEG|Low-residue diet package with normal amount of 1.5L PEG-ELS
11113882|NCT01665157|BG003|Baseline|Total|Total of all reporting groups
11113883|NCT01665157|FG000|Participant Flow|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
11113884|NCT01665157|FG001|Participant Flow|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
11113885|NCT01665157|FG002|Participant Flow|Low-residue Diet Package and 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
11113886|NCT01665157|OG000|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
11113887|NCT01665157|OG001|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
11113888|NCT01665157|OG002|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
11113889|NCT01665157|OG002|Outcome|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with reduced volume low volume 1.5L PEG-ELS
11113890|NCT01665157|OG002|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
11113891|NCT01665157|OG002|Outcome|Low-residue Diet Package and 1.5 L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
11113892|NCT01665157|OG001|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with 2L PEG-ELS
11113893|NCT01665157|OG002|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with reduced volume 1.5L PEG-ELS
11113894|NCT01665157|EG000|Reported Event|Low-residue Diet Package|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
11113895|NCT01665157|EG001|Reported Event|Self-controlled Diet|Self-controlled diet with normal amount 2L PEG-ELS
11113896|NCT01665157|EG002|Reported Event|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
11113897|NCT01665170|BG000|Baseline|Placebo|Placebo arm
11113898|NCT01665170|BG001|Baseline|Verum|Verum arm - Pascoflair 425mg
11113899|NCT01665170|BG002|Baseline|Total|Total of all reporting groups
11113900|NCT01665170|FG000|Participant Flow|Placebo|Placebo arm, 3 x 1 tablet per every day for 3 days
10846055|NCT00272779|OG000|Outcome|All Participants With Pharmacogenetic Blood Samples|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
11113901|NCT01665170|FG001|Participant Flow|Verum|Verum arm - Pascoflair 425mg, 3 x 1 tablet per every day for 3 days
11113902|NCT01665170|OG000|Outcome|Placebo|Placebo arm
11113903|NCT01665170|OG001|Outcome|Verum|Verum arm - Pascoflair 425mg
11113904|NCT01665170|OG000|Outcome|Verum|Verum arm - Pascoflair 425mg
11113905|NCT01665170|OG001|Outcome|Placebo|Placebo arm
11113906|NCT01665170|EG000|Reported Event|Placebo|Placebo arm
11113907|NCT01665170|EG001|Reported Event|Verum|Verum arm - Pascoflair 425mg
11113908|NCT01665430|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
11113909|NCT01665430|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks (q4w) up to 104 weeks.
11113910|NCT01665430|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
11113911|NCT01665430|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
11113912|NCT01665508|BG000|Baseline|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
11113913|NCT01665508|FG000|Participant Flow|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
11113914|NCT01665508|OG000|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)"
11113915|NCT01665508|OG001|Outcome|Baseline|results prior to nebivolol start
11113916|NCT01665508|OG000|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
11113917|NCT01665508|OG001|Outcome|Baseline|results off nebivolol
11113918|NCT01665508|OG000|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~this data was incomplete and not useful for analysis"
11113919|NCT01665508|OG001|Outcome|Baseline|results without nebivolol
11113920|NCT01665508|EG000|Reported Event|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
11113921|NCT01665599|BG000|Baseline|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
11113922|NCT01665599|FG000|Participant Flow|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
11113923|NCT01665599|OG000|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
11113924|NCT01665599|EG000|Reported Event|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
11113925|NCT01665768|BG000|Baseline|Everolimus and Rituximab|"Everolimus daily for one year and IV rituximab four times during that year.~Everolimus: The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL. Previously the study allowed for starting doses of 5mg and 10mg; the starting dose was reduced in subsequent amendments due to a high incidence of dose reductions. 2.5mg was the most frequent daily dose for all patients, and the entire population was analyzed as one arm.~Rituximab: 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)"
11113926|NCT01665768|FG000|Participant Flow|Everolimus and Rituximab|"Everolimus daily for one year and IV rituximab four times during that year.~Everolimus: The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL. Previously the study allowed for starting doses of 5mg and 10mg; the starting dose was reduced in subsequent amendments due to a high incidence of dose reductions. 2.5mg was the most frequent daily dose for all patients, and the entire population was analyzed as one arm.~Rituximab: 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)"
11113927|NCT01665768|OG000|Outcome|Everolimus and Rituximab|"Everolimus daily for one year and IV rituximab four times during that year.~Everolimus: The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL. Previously the study allowed for starting doses of 5mg and 10mg; the starting dose was reduced in subsequent amendments due to a high incidence of dose reductions. 2.5mg was the most frequent daily dose for all patients, and the entire population was analyzed as one arm.~Rituximab: 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)"
11113928|NCT01665768|EG000|Reported Event|Everolimus and Rituximab|"Everolimus daily for one year and IV rituximab four times during that year.~Everolimus: The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL. Previously the study allowed for starting doses of 5mg and 10mg; the starting dose was reduced in subsequent amendments due to a high incidence of dose reductions. 2.5mg was the most frequent daily dose for all patients, and the entire population was analyzed as one arm.~Rituximab: 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)"
11113929|NCT01665807|BG000|Baseline|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
11113930|NCT01665807|BG001|Baseline|Repeat Self-administered Intradermal|"Self-administration (2) of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
11113931|NCT01665807|BG002|Baseline|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
11113932|NCT01665807|BG003|Baseline|Total|Total of all reporting groups
11113933|NCT01665807|FG000|Participant Flow|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
11113934|NCT01665807|FG001|Participant Flow|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
11113935|NCT01665807|FG002|Participant Flow|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
11113936|NCT01665807|OG000|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
11113937|NCT01665807|OG001|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
11113938|NCT01665807|OG002|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
11113939|NCT01665807|EG000|Reported Event|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
11113940|NCT01665807|EG001|Reported Event|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
11113941|NCT01665807|EG002|Reported Event|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
11113942|NCT01665872|BG000|Baseline|Cognitive-Behavioral Group Therapy|Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador
11113943|NCT01665872|BG001|Baseline|Standard of Care - Cognitive-Behavioral Group Therapy|Stress Management Class delivered in public housing sites by only a clinician
11113944|NCT01665872|BG002|Baseline|Total|Total of all reporting groups
11113945|NCT01665872|FG000|Participant Flow|Cognitive-Behavioral Group Therapy|"8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention co-facilitated by mental health clinician and a Community Mental Health Ambassador (peer).~Cognitive-Behavioral Group Therapy: CBT Group"
11113946|NCT01665872|FG001|Participant Flow|Standard of Care - Cognitive-Behavioral Group Therapy|"8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention administered by mental health clinician.~Cognitive-Behavioral Group Therapy: CBT Group"
11113947|NCT01665872|OG000|Outcome|Cognitive-Behavioral Group Therapy|Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador
11113948|NCT01665872|OG001|Outcome|Standard of Care - Cognitive-Behavioral Group Therapy|Stress Management Class delivered in public housing sites by only a clinician
11113949|NCT01665872|EG000|Reported Event|Cognitive-Behavioral Group Therapy|Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador
11113950|NCT01665872|EG001|Reported Event|Standard of Care - Cognitive-Behavioral Group Therapy|Stress Management Class delivered in public housing sites by only a clinician
11113951|NCT01665911|BG000|Baseline|All Participants|"1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design~Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design"
11113952|NCT01665911|FG000|Participant Flow|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:~. 1.5 mg Sodium Fluoride in 100 ml milk: .~1.5 mg Sodium Fluoride in 200 ml milk~3.0 mg Sodium Fluoride in 100 ml milk~3.0 mg Sodium Fluoride in 200 ml milk~0 mg fluoride in 200 ml milk"
11113953|NCT01665911|OG000|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
11113954|NCT01665911|OG000|Outcome|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:~. 1.5 mg Sodium Fluoride in 100 ml milk: .~1.5 mg Sodium Fluoride in 200 ml milk~3.0 mg Sodium Fluoride in 100 ml milk~3.0 mg Sodium Fluoride in 200 ml milk~0 mg fluoride in 200 ml milk"
11113955|NCT01665911|EG000|Reported Event|Arm/Group All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design~Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design."
11113956|NCT01665950|BG000|Baseline|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
11113957|NCT01665950|BG001|Baseline|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
11113958|NCT01665950|BG002|Baseline|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
11113959|NCT01665950|BG003|Baseline|Total|Total of all reporting groups
11113960|NCT01665950|FG000|Participant Flow|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
11113961|NCT01665950|FG001|Participant Flow|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
11113962|NCT01665950|FG002|Participant Flow|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
11113963|NCT01665950|OG000|Outcome|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
11348289|NCT04189081|FG002|Participant Flow|Positive Control|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11113964|NCT01665950|OG001|Outcome|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
11113965|NCT01665950|OG002|Outcome|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
11113966|NCT01665950|EG000|Reported Event|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
11113967|NCT01665950|EG001|Reported Event|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
11113968|NCT01665950|EG002|Reported Event|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
11113969|NCT01666002|BG000|Baseline|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
11113970|NCT01666002|BG001|Baseline|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
11113971|NCT01666002|BG002|Baseline|Total|Total of all reporting groups
11113972|NCT01666002|FG000|Participant Flow|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture."
11113973|NCT01666002|FG001|Participant Flow|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
11113974|NCT01666002|OG000|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~After 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49)."
11113975|NCT01666002|OG001|Outcome|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
11113976|NCT01666002|OG000|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
11113977|NCT01666002|EG000|Reported Event|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~No patients reported complications or adverse events after 2 sessions."
11113978|NCT01666002|EG001|Reported Event|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
11113979|NCT01666119|BG000|Baseline|BEMA Buprenorphine NX Films|"BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.~BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively."
11113980|NCT01666119|FG000|Participant Flow|BEMA Buprenorphine NX Films|"BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).~BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg)."
11113981|NCT01666119|OG000|Outcome|BEMA Buprenorphine/NX Films|BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
11113982|NCT01666119|EG000|Reported Event|BEMA Buprenorphine NX Films|"BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.~BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively."
11113983|NCT01666197|BG000|Baseline|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
11113984|NCT01666197|BG001|Baseline|Placebo|placebo: placebo
11113985|NCT01666197|BG002|Baseline|Total|Total of all reporting groups
11113986|NCT01666197|FG000|Participant Flow|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
11113987|NCT01666197|FG001|Participant Flow|Placebo|placebo: placebo
11113988|NCT01666197|OG000|Outcome|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
11113989|NCT01666197|OG001|Outcome|Placebo|placebo: placebo
11113990|NCT01666197|EG000|Reported Event|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
11113991|NCT01666197|EG001|Reported Event|Placebo|placebo: placebo
11113992|NCT01666210|BG000|Baseline|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
11113993|NCT01666210|BG001|Baseline|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
11113994|NCT01666210|BG002|Baseline|Total|Total of all reporting groups
11113995|NCT01666210|FG000|Participant Flow|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
11113996|NCT01666210|FG001|Participant Flow|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
11113997|NCT01666210|OG000|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
11113998|NCT01666210|OG001|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
11113999|NCT01666210|EG000|Reported Event|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
11114000|NCT01666210|EG001|Reported Event|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
11114001|NCT01666314|BG000|Baseline|Placebo + Orteronel 200 mg (Japan)|Orteronel placebo-matching tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
11114002|NCT01666314|BG001|Baseline|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114003|NCT01666314|BG002|Baseline|Placebo + Orteronel 300 mg (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114004|NCT01666314|BG003|Baseline|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114005|NCT01666314|BG004|Baseline|Placebo + Orteronel 200 mg (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114006|NCT01666314|BG005|Baseline|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114007|NCT01666314|BG006|Baseline|Placebo + Orteronel 400 mg (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114008|NCT01666314|BG007|Baseline|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114009|NCT01666314|BG008|Baseline|Total|Total of all reporting groups
11114010|NCT01666314|FG000|Participant Flow|Placebo + Orteronel 200 mg (Japan)|Orteronel placebo-matching tablets or Orteronel 200 mg, tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
11114011|NCT01666314|FG001|Participant Flow|Placebo + Orteronel 300 mg (Japan)|Orteronel placebo-matching tablets or Orteronel 300 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114012|NCT01666314|FG002|Participant Flow|Placebo + Orteronel 200 mg (Ex-Japan)|Orteronel placebo-matching tablets, or Orteronel 200 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114013|NCT01666314|FG003|Participant Flow|Placebo + Orteronel 400 mg (Ex-Japan)|Orteronel placebo-matching tablets, or Orteronel 400 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114014|NCT01666314|OG000|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114015|NCT01666314|OG001|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114016|NCT01666314|OG000|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114017|NCT01666314|OG001|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114018|NCT01666314|OG000|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114019|NCT01666314|OG001|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114020|NCT01666314|OG002|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114021|NCT01666314|OG003|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114022|NCT01666314|OG004|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114023|NCT01666314|OG005|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114024|NCT01666314|OG000|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114025|NCT01666314|OG002|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114026|NCT01666314|OG003|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114027|NCT01666314|OG001|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan and ex-Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114028|NCT01666314|EG000|Reported Event|Placebo|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114029|NCT01666314|EG001|Reported Event|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114030|NCT01666314|EG002|Reported Event|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114031|NCT01666314|EG003|Reported Event|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114032|NCT01666314|EG004|Reported Event|Orteronel 400mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
11114033|NCT01666444|BG000|Baseline|Pegylated Liposomal Doxorubicin (PLD) + Placebo|Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo
11114034|NCT01666444|BG001|Baseline|Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)|Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
11114035|NCT01666444|BG002|Baseline|Total|Total of all reporting groups
11114036|NCT01666444|FG000|Participant Flow|Pegylated Liposomal Doxorubicin (PLD) + Placebo|Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo
11114037|NCT01666444|FG001|Participant Flow|Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)|Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
11114038|NCT01666444|OG000|Outcome|Pegylated Liposomal Doxorubicin (PLD) + Placebo|Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo
11114039|NCT01666444|OG001|Outcome|Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)|Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
11114040|NCT01666444|EG000|Reported Event|Pegylated Liposomal Doxorubicin (PLD) + Placebo|Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo
11114041|NCT01666444|EG001|Reported Event|Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)|Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
11114042|NCT01666652|BG000|Baseline|TDENV-PIV alum1|"1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with Alum adjuvant"
11114043|NCT01666652|BG001|Baseline|TDENV-PIV alum4|"4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~4 µg TDENV-PIV with Alum adjuvant"
11114044|NCT01666652|BG002|Baseline|TDENV-PIV AS01E1|"1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with AS01E1 adjuvant"
11114045|NCT01666652|BG003|Baseline|TDENV-PIV AS03B1|"1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with AS03B1 adjuvant"
11114046|NCT01666652|BG004|Baseline|Placebo|"Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days~Phosphate buffered saline"
11114047|NCT01666652|BG005|Baseline|Total|Total of all reporting groups
11114048|NCT01666652|FG000|Participant Flow|TDENV-PIV alum1|"1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with Alum adjuvant"
11114049|NCT01666652|FG001|Participant Flow|TDENV-PIV alum4|"4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~4 µg TDENV-PIV with Alum adjuvant"
11114050|NCT01666652|FG002|Participant Flow|TDENV-PIV AS01E1|"1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with AS01E1 adjuvant"
11114051|NCT01666652|FG003|Participant Flow|TDENV-PIV AS03B1|"1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with AS03B1 adjuvant"
11114052|NCT01666652|FG004|Participant Flow|Placebo|"Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days~Phosphate buffered saline"
11114053|NCT01666652|OG000|Outcome|TDENV-PIV alum1|"1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with Alum adjuvant"
11114054|NCT01666652|OG001|Outcome|TDENV-PIV alum4|"4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~4 µg TDENV-PIV with Alum adjuvant"
11114055|NCT01666652|OG002|Outcome|TDENV-PIV AS01E1|"1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with AS01E1 adjuvant"
11114056|NCT01666652|OG003|Outcome|TDENV-PIV AS03B1|"1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with AS03B1 adjuvant"
11114057|NCT01666652|OG004|Outcome|Placebo|"Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days~Phosphate buffered saline"
11114058|NCT01666652|EG000|Reported Event|TDENV-PIV alum1|"1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with Alum adjuvant"
11114059|NCT01666652|EG001|Reported Event|TDENV-PIV alum4|"4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~4 µg TDENV-PIV with Alum adjuvant"
11114060|NCT01666652|EG002|Reported Event|TDENV-PIV AS01E1|"1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with AS01E1 adjuvant"
11114061|NCT01666652|EG003|Reported Event|TDENV-PIV AS03B1|"1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days~1 µg TDENV-PIV with AS03B1 adjuvant"
11114062|NCT01666652|EG004|Reported Event|Placebo|"Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days~Phosphate buffered saline"
11114063|NCT01666730|BG000|Baseline|Treatment (Metformin Hydrochloride, FOLFOX)|"Patients receive metformin hydrochloride PO BID on days 1-14 and FOLFOX therapy comprising leucovorin calcium IV over 120 minutes, fluorouracil IV continuously over 46 hours, and oxaliplatin IV over 120 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~laboratory biomarker analysis: Correlative studies"
11348290|NCT04189081|OG000|Outcome|Water Control|"Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~Water Control: negative control"
11114064|NCT01666730|FG000|Participant Flow|Treatment (Metformin Hydrochloride, FOLFOX)|"Patients receive metformin hydrochloride PO BID on days 1-14 and FOLFOX therapy comprising leucovorin calcium IV over 120 minutes, fluorouracil IV continuously over 46 hours, and oxaliplatin IV over 120 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~laboratory biomarker analysis: Correlative studies"
11114065|NCT01666730|OG000|Outcome|Treatment (Metformin Hydrochloride, FOLFOX)|"Patients receive metformin hydrochloride PO BID on days 1-14 and FOLFOX therapy comprising leucovorin calcium IV over 120 minutes, fluorouracil IV continuously over 46 hours, and oxaliplatin IV over 120 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~laboratory biomarker analysis: Correlative studies"
11114066|NCT01666730|EG000|Reported Event|Treatment (Metformin Hydrochloride, FOLFOX)|"Patients receive metformin hydrochloride PO BID on days 1-14 and FOLFOX therapy comprising leucovorin calcium IV over 120 minutes, fluorouracil IV continuously over 46 hours, and oxaliplatin IV over 120 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~laboratory biomarker analysis: Correlative studies"
11114067|NCT01666782|BG000|Baseline|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
11348291|NCT04189081|OG001|Outcome|Experimental Mouth Rinse|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11348292|NCT04189081|OG002|Outcome|Positive Control|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11348293|NCT04189081|EG000|Reported Event|Water Control|"Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~Water Control: negative control"
11348294|NCT04189081|EG001|Reported Event|Experimental Mouth Rinse|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11348295|NCT04189081|EG002|Reported Event|Positive Control|"dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.~dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces."
11348296|NCT04186780|BG000|Baseline|Intervention Group|"Intervention group: patients with borderline cholesterol consumed two cereal bars with Shiitake per day for 66 days.~Shiitake cereal bar: patients with borderline cholesterol exposed to bars with Shiitake"
11348297|NCT04186780|BG001|Baseline|Placebo Group|"Patients with borderline cholesterol consumed two placebo cereal bars for 66 days.~Cereal bar: patients with borderline cholesterol exposed to placebo cereal bars."
11348298|NCT04186780|BG002|Baseline|Total|Total of all reporting groups
11348299|NCT04186780|FG000|Participant Flow|Intervention Group|"Intervention group: patients with borderline cholesterol consumed two cereal bars with Shiitake per day for 66 days.~Shiitake cereal bar: patients with borderline cholesterol exposed to bars with Shiitake"
11348300|NCT04186780|FG001|Participant Flow|Placebo Group|"Patients with borderline cholesterol consumed two placebo cereal bars for 66 days.~Placebo cereal bar: patients with borderline cholesterol exposed to cereal bars without Shiitake."
11348301|NCT04186780|OG000|Outcome|Placebo Group|Participants received two placebo food bars/day to consume for 66 days. Placebo: Placebo food bars with 25 g each.
11348302|NCT04186780|OG001|Outcome|Intervention Group|Participants received two shiitake food bars/day to consume for 66 days. Intervention group: Shiitake bars with 25 g each.
11348303|NCT04186780|OG000|Outcome|Placebo Group|Participants received two placebo bars/day to consume for 66 days. Placebo group: Bars with 25 g each.
11348304|NCT04186780|OG001|Outcome|Intervention Group|Participants received two shiitake bars/day to consume for 66 days. Intervention: Shiitake bars with 25 g each.
11348305|NCT04186780|EG000|Reported Event|Intervention Group|"Intervention group: patients with borderline cholesterol consumed two cereal bars with Shiitake per day for 66 days.~The patients can manifest allergy to ingredients the bars"
11348306|NCT04186780|EG001|Reported Event|Placebo Group|"Patients with borderline cholesterol consumed two placebo cereal bars for 66 days.~The patients can manifest allergy to ingredients the bars."
11348307|NCT04186806|BG000|Baseline|3M Spray Then Biotene Spray|3M Dry Mouth Moisturizing Spray then Biotene Dry Mouth Moisturizing Spray
11348308|NCT04186806|BG001|Baseline|Biotene Spray Then 3M Spray|Biotene Dry Mouth Moisturizing Spray then 3M Dry Mouth Moisturizing Spray
11348309|NCT04186806|BG002|Baseline|Total|Total of all reporting groups
11348310|NCT04186806|FG000|Participant Flow|3M Dry Mouth Moisturizing Spray Then Biotene Moisturizing Mouth Spray|"Dry Mouth Agent: 3M Dry Mouth Moisturizing Spray: 20 ml bottle~or~Dry Mouth Agent: Biotene Moisturizing Mouth Spray: 44 ml bottle"
11348311|NCT04186806|FG001|Participant Flow|Biotene Moisturizing Mouth Spray Then 3M Dry Mouth Moisturizing Spray|"Dry mouth agent: Biotene Moisturizing Mouth Spray: 44 ml bottle~or~Dry mouth agent: 3M Dry Mouth Moisturizing Spray: 20 ml bottle"
11348312|NCT04186806|OG000|Outcome|3M(TM) Dry Mouth Moisturizing Spray|"Dry mouth agent~3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle~Distilled water: 15 ml"
11348313|NCT04186806|OG001|Outcome|Biotene Moisturizing Mouth Spray|"Dry mouth agent~Biotene Moisturizing Mouth Spray: 44.3 ml bottle~Distilled water: 15 ml"
11348314|NCT04186806|OG000|Outcome|3M Dry Mouth Moisturizing Spray|"Dry mouth agent~3M Dry Mouth Moisturizing Spray: 20 ml bottle~Distilled water: 15 ml"
11348315|NCT04186806|EG000|Reported Event|3M(TM) Dry Mouth Moisturizing Spray|"Dry mouth agent~3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle~Distilled water: 15 ml"
11348316|NCT04186806|EG001|Reported Event|Biotene Moisturizing Mouth Spray|"Dry mouth agent~Biotene Moisturizing Mouth Spray: 44.3 ml bottle~Distilled water: 15 ml"
11348317|NCT04186481|BG000|Baseline|Minitac Ti 2.0 Suture Anchor|"Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor~MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand."
11348318|NCT04186481|FG000|Participant Flow|Minitac Ti 2.0 Suture Anchor|"Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor~MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand."
11348319|NCT04186481|OG000|Outcome|Minitac Ti 2.0 Suture Anchor|"Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor~MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand."
11114068|NCT01666782|BG001|Baseline|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
11114069|NCT01666782|BG002|Baseline|Total|Total of all reporting groups
11114070|NCT01666782|FG000|Participant Flow|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
11114071|NCT01666782|FG001|Participant Flow|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
11114072|NCT01666782|OG000|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
11114073|NCT01666782|OG001|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
11114074|NCT01666782|EG000|Reported Event|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
11114075|NCT01666782|EG001|Reported Event|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
11114076|NCT01666912|BG000|Baseline|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
11114077|NCT01666912|BG001|Baseline|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
11114078|NCT01666912|BG002|Baseline|Total|Total of all reporting groups
11114079|NCT01666912|FG000|Participant Flow|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
11114080|NCT01666912|FG001|Participant Flow|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
11114081|NCT01666912|OG000|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
11348320|NCT04186481|EG000|Reported Event|Minitac Ti 2.0 Suture Anchor|"Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor~MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand."
11114082|NCT01666912|OG001|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
11114083|NCT01666912|EG000|Reported Event|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
11114084|NCT01666912|EG001|Reported Event|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
11114085|NCT01666951|BG000|Baseline|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
11114086|NCT01666951|BG001|Baseline|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
11114087|NCT01666951|BG002|Baseline|Total|Total of all reporting groups
11114088|NCT01666951|FG000|Participant Flow|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
11114089|NCT01666951|FG001|Participant Flow|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
11114090|NCT01666951|OG000|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
11114091|NCT01666951|OG001|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
11114092|NCT01666951|EG000|Reported Event|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
11114093|NCT01666951|EG001|Reported Event|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
11114094|NCT01667029|BG000|Baseline|All Study Participants|"Participants who were randomized to either Group A or Group B:~Group A: Placebo daily for two weeks, washout period of one week, sulfasalazine for 2 week period Group B: Sulfasalazine daily for two weeks, washout period of one week, placebo for 2 week period."
11114095|NCT01667029|FG000|Participant Flow|Sulfasalazine Then Placebo|Sulfasalazine (1 g oral twice daily) for two weeks, washout period of one week, placebo for 2 week period
11114096|NCT01667029|FG001|Participant Flow|Placebo Then Sulfasalazine|Oral placebo pill twice daily for two weeks, washout period of one week, sulfasalazine for 2 week period
11114097|NCT01667029|OG000|Outcome|Sulfasalazine|"1 g oral twice daily for 2 weeks~Sulfasalazine"
11114098|NCT01667029|OG001|Outcome|Placebo|"oral placebo pill twice daily for two weeks.~placebo"
11114099|NCT01667029|EG000|Reported Event|Sulfasalazine|"1 g oral twice daily for 2 weeks~Sulfasalazine"
11114100|NCT01667029|EG001|Reported Event|Placebo|"oral placebo pill twice daily for two weeks.~placebo"
11114101|NCT01667107|BG000|Baseline|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
11114102|NCT01667107|BG001|Baseline|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
11114103|NCT01667107|BG002|Baseline|Total|Total of all reporting groups
11114104|NCT01667107|FG000|Participant Flow|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
11114105|NCT01667107|FG001|Participant Flow|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
11114106|NCT01667107|OG000|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
11114107|NCT01667107|OG001|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
11114108|NCT01667107|EG000|Reported Event|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
11114109|NCT01667107|EG001|Reported Event|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
11348321|NCT04184999|BG000|Baseline|Intracameral Dexamethasone + Post-operative Topical Prednisolone|"dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone~dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid~Prednisolone Acetate: topical ophthalmic drop"
11348322|NCT04184999|BG001|Baseline|Post-operative Topical Prednisolone|"topical ophthalmic prednisolone acetate~Prednisolone Acetate: topical ophthalmic drop"
11114110|NCT01667224|BG000|Baseline|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
11114111|NCT01667224|BG001|Baseline|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
11114112|NCT01667224|BG002|Baseline|Total|Total of all reporting groups
11114113|NCT01667224|FG000|Participant Flow|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
11114114|NCT01667224|FG001|Participant Flow|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
11114115|NCT01667224|OG000|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
11114116|NCT01667224|OG001|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
11114117|NCT01667224|OG000|Outcome|Actiponin(450mg/Day) for 12week|Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.
11114118|NCT01667224|OG001|Outcome|Placebo (450mg/Day) for 12 Week|Placebo: Amount and calorie of placebo are same with Actiponin
11114119|NCT01667224|EG000|Reported Event|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
11114120|NCT01667224|EG001|Reported Event|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
11114121|NCT01667250|BG000|Baseline|GammaCore Active Device|"Subjects will use an Active GammaCore Device~GammaCore Active Device"
11114122|NCT01667250|BG001|Baseline|GammaCore Sham Device|Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
11114123|NCT01667250|BG002|Baseline|Total|Total of all reporting groups
11114124|NCT01667250|FG000|Participant Flow|GammaCore Active Device|"Subjects will use an Active GammaCore Device~GammaCore Active Device"
11114125|NCT01667250|FG001|Participant Flow|GammaCore Sham Device|Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
11114126|NCT01667250|FG002|Participant Flow|No Treatment (run-in, Enrollment Period)|The run-in period was 1 month, Subject who did not fulfill the inclusion and/or exclusion criteria was not randomized to the treatment groups
11114127|NCT01667250|OG000|Outcome|GammaCore Active Device|"Subjects will use an Active GammaCore Device~GammaCore Active Device"
11114128|NCT01667250|OG001|Outcome|GammaCore Sham Device|Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
11114129|NCT01667250|OG000|Outcome|GammaCore Active Device|Subjects will use an Active GammaCore Device GammaCore Active Device
11114130|NCT01667250|EG000|Reported Event|GammaCore Active Device|"Subjects will use an Active GammaCore Device~GammaCore Active Device"
11114131|NCT01667250|EG001|Reported Event|GammaCore Sham Device|Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
11114132|NCT01667406|BG000|Baseline|Kisspeptin-54 1.6 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg
11114133|NCT01667406|BG001|Baseline|Kispeptin-54 3.2 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
11114134|NCT01667406|BG002|Baseline|Kisspeptin-54 6.4 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
11114135|NCT01667406|BG003|Baseline|Kisspeptin-54 12.8 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg
11114136|NCT01667406|BG004|Baseline|OHSS - Kisspeptin-54 3.2 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
11114137|NCT01667406|BG005|Baseline|OHSS - Kisspeptin-54 6.4 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
11114138|NCT01667406|BG006|Baseline|OHSS - Kisspeptin-54 9.6 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg
11114139|NCT01667406|BG007|Baseline|OHSS - Kisspeptin-54 12.8 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg
11114140|NCT01667406|BG008|Baseline|Kisspeptin-54 9.6 + 9.6|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later
11114141|NCT01667406|BG009|Baseline|Kisspeptin-54 9.6 + Saline|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
11114142|NCT01667406|BG010|Baseline|Total|Total of all reporting groups
11114143|NCT01667406|FG000|Participant Flow|Kisspeptin-54 1.6 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg
11114144|NCT01667406|FG001|Participant Flow|Kispeptin-54 3.2 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
11114145|NCT01667406|FG002|Participant Flow|Kisspeptin-54 6.4 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
11348323|NCT04184999|BG002|Baseline|Total|Total of all reporting groups
11114146|NCT01667406|FG003|Participant Flow|Kisspeptin-54 12.8 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg
11114147|NCT01667406|FG004|Participant Flow|OHSS - Kisspeptin-54 3.2 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
11114148|NCT01667406|FG005|Participant Flow|OHSS - Kisspeptin-54 6.4 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
11114149|NCT01667406|FG006|Participant Flow|OHSS - Kisspeptin-54 9.6 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg
11114150|NCT01667406|FG007|Participant Flow|OHSS - Kisspeptin-54 12.8 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg
11114151|NCT01667406|FG008|Participant Flow|Kisspeptin-54 9.6 + 9.6|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later
11114152|NCT01667406|FG009|Participant Flow|Kisspeptin-54 9.6 + Saline|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
11114153|NCT01667406|OG000|Outcome|Kisspeptin-54 1.6 Nmol/kg Single|Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.
11114154|NCT01667406|OG001|Outcome|Kisspeptin-54 3.2nmol/kg Single|Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.
11114155|NCT01667406|OG002|Outcome|Kisspeptin-54 6.4 Nmol/kg Single|Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.
11114156|NCT01667406|OG003|Outcome|Kisspeptin-54 12.8nmol/kg Single|Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.
11114157|NCT01667406|OG004|Outcome|Kisspeptin-54, OHSS 3.2nmol/Kg Single|Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.
11114158|NCT01667406|OG005|Outcome|Kisspeptin-54, OHSS 6.4nmol/Kg Single|Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.
11114159|NCT01667406|OG006|Outcome|Kisspeptin-54, OHSS 9.6nmol/Kg Single|Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.
11114160|NCT01667406|OG007|Outcome|Kisspeptin-54, OHSS 12.8nmol/Kg Single|Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.
11114161|NCT01667406|OG008|Outcome|Kisspeptin-54 OHSS, 9.6 + 9.6|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later
11114162|NCT01667406|OG009|Outcome|Kisspeptin-54 OHSS, 9.6 + Saline|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
11114163|NCT01667406|OG000|Outcome|KP-54 1.6nmol/kg Single|Participants undergoing IV treatment with trigger dose 1.6nmol/kg had blood level of luteinising hormone (LH) measured at T=0
11114164|NCT01667406|OG001|Outcome|KP-54 3.2nmol/kg Single|Participants undergoing IV treatment with trigger dose 3.2nmol/kg had blood level of luteinising hormone (LH) measured at T=0
11114165|NCT01667406|OG002|Outcome|KP-54 6.4nmol/kg Single|Participants undergoing IV treatment with trigger dose 6.4nmol/kg had blood level of luteinising hormone (LH) measured at T=0
11114166|NCT01667406|OG003|Outcome|KP-54 12.8nmol/kg Single|Participants undergoing IV treatment with trigger dose 12.8nmol/kg had blood level of luteinising hormone (LH) measured at T=0
11114167|NCT01667406|OG004|Outcome|KP-54 OHSS 3.2nmol/kg Single|Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 3.2nmol/kg had blood level of luteinising hormone (LH) measured at T=0
11114168|NCT01667406|OG005|Outcome|KP-54 OHSS 6.4nmol/kg Single|Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 6.4nmol/kg had blood level of luteinising hormone (LH) measured at T=0
11114169|NCT01667406|OG006|Outcome|KP-54 OHSS 9.6nmol/kg|Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 9.6nmol/kg had blood level of luteinising hormone (LH) measured at T=0
11114170|NCT01667406|OG007|Outcome|KP-54 OHSS 12.8nmol/kg Single|Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 12.8nmol/kg had blood level of luteinising hormone (LH) measured at T=0
11114171|NCT01667406|OG008|Outcome|KP-54 OHSS 9.6 +9.6 Nmol/kg|Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 9.6nmol/kg followed by another injection of KP-54 9.6nmol/kg 10 hours later, had blood level of luteinising hormone (LH) measured at T=0
11114172|NCT01667406|OG009|Outcome|KP-54 OHSS 9.6 + Saline|Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 9.6nmol/kg followed by another injection of saline10 hours later, had blood level of luteinising hormone (LH) measured at T=0
11114173|NCT01667406|OG000|Outcome|Kisspeptin-54, 1.6 Single|"Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg~Kisspeptin 1.6nmol/kg: single kisspeptin dose 1.6 nmol/kg subcutaneously"
11114174|NCT01667406|OG001|Outcome|Kisspeptin-54, 3.2 Single|"Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg~Kisspeptin 3.2nmol/kg: single kisspeptin dose 3.2 nmol/kg subcutaneously"
11114175|NCT01667406|OG002|Outcome|Kisspeptin-54, 6.4 Single|"Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg~Kisspeptin 6.4nmol/kg: single kisspeptin dose 6.4 nmol/kg subcutaneously"
11114176|NCT01667406|OG003|Outcome|Kisspeptin-54, 12.8 Single|"Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg~Kisspeptin 12.8nmol/kg: single kisspeptin dose 12.8 nmol/kg subcutaneously"
11114177|NCT01667406|OG004|Outcome|Kisspeptin-54 OHSS, 3.2 Single|"Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg~Kisspeptin 3.2nmol/kg: single kisspeptin dose 3.2 nmol/kg subcutaneously"
11114178|NCT01667406|OG005|Outcome|Kisspeptin-54 OHSS, 6.4 Single|"Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg~Kisspeptin 6.4nmol/kg: single kisspeptin dose 6.4 nmol/kg subcutaneously"
11114179|NCT01667406|OG006|Outcome|Kisspeptin-54 OHSS, 9.6 Single|"Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg~Kisspeptin 9.6nmol/kg: single kisspeptin dose 9.6 nmol/kg subcutaneously"
11114180|NCT01667406|OG007|Outcome|Kisspeptin-54 OHSS, 12.8 Single|"Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg~Kisspeptin 12.8nmol/kg: single kisspeptin dose 12.8 nmol/kg subcutaneously"
11114181|NCT01667406|OG008|Outcome|Kisspeptin-54 OHSS, 9.6 + 9.6|"Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later~Kisspeptin 9.6 nmol/kg double: kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously"
11114182|NCT01667406|OG009|Outcome|Kisspeptin-54 OHSS, 9.6 + Saline|"Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later~Kisspeptin 9.6 nmol/kg + saline: kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart"
11114183|NCT01667406|OG000|Outcome|Kisspeptin-54 1.6 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg
11114184|NCT01667406|OG001|Outcome|Kispeptin-54 3.2 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
11114185|NCT01667406|OG002|Outcome|Kisspeptin-54 6.4 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
11114186|NCT01667406|OG003|Outcome|Kisspeptin-54 12.8 Single|Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg
11114187|NCT01667406|OG004|Outcome|OHSS - Kisspeptin-54 3.2 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
11114188|NCT01667406|OG005|Outcome|OHSS - Kisspeptin-54 6.4 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
11114189|NCT01667406|OG006|Outcome|OHSS - Kisspeptin-54 9.6 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg
11114190|NCT01667406|OG007|Outcome|OHSS - Kisspeptin-54 12.8 Single|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg
11114191|NCT01667406|OG008|Outcome|Kisspeptin-54 9.6 + 9.6|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later
11114192|NCT01667406|OG009|Outcome|Kisspeptin-54 9.6 + Saline|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
11114193|NCT01667406|EG000|Reported Event|KP-54 1.6nmol/kg Single|Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.
11114194|NCT01667406|EG001|Reported Event|KP-54 3.2nmol/kg Single|Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.
11114195|NCT01667406|EG002|Reported Event|KP-54 6.4nmol/kg Single|Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.
11114196|NCT01667406|EG003|Reported Event|KP-54 12.8nmol/kg Single|Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.
11114197|NCT01667406|EG004|Reported Event|KP-54 OHSS 3.2nmol/kg Single|Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.
11114198|NCT01667406|EG005|Reported Event|KP-54 OHSS 6.4nmol/kg Single|Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.
11114199|NCT01667406|EG006|Reported Event|KP-54 OHSS 9.6nmol/kg Single|Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.
11114200|NCT01667406|EG007|Reported Event|KP-54 OHSS 12.8nmol/kg Single|Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.
11114201|NCT01667406|EG008|Reported Event|KP-54 OHSS 9.6 + 9.6 Nmol/kg|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later
11114202|NCT01667406|EG009|Reported Event|KP-54 OHSS 9.6nmol/kg + Saline|Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
11114203|NCT01667419|BG000|Baseline|Cohort 1 Vemurafenib|Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
11114204|NCT01667419|BG001|Baseline|Cohort 1 Placebo|Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
11114205|NCT01667419|BG002|Baseline|Cohort 2 Vemurafenib|Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
11114206|NCT01667419|BG003|Baseline|Cohort 2 Placebo|Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
11114207|NCT01667419|BG004|Baseline|Total|Total of all reporting groups
11114208|NCT01667419|FG000|Participant Flow|Cohort 1 Vemurafenib|Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 milligrams (mg) twice daily, in 28-day cycles, for up to 52 weeks
11114209|NCT01667419|FG001|Participant Flow|Cohort 1 Placebo|Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
11114210|NCT01667419|FG002|Participant Flow|Cohort 2 Vemurafenib|Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
11114211|NCT01667419|FG003|Participant Flow|Cohort 2 Placebo|Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
11114212|NCT01667419|OG000|Outcome|Cohort 1 Vemurafenib|Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
11114213|NCT01667419|OG001|Outcome|Cohort 1 Placebo|Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
11114214|NCT01667419|OG002|Outcome|Cohort 2 Vemurafenib|Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
11114215|NCT01667419|OG003|Outcome|Cohort 2 Placebo|Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
11114216|NCT01667419|OG001|Outcome|Cohort 2 Vemurafenib|Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
11114217|NCT01667419|EG000|Reported Event|Cohort 1 Vemurafenib|Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
11114218|NCT01667419|EG001|Reported Event|Cohort 1 Placebo|Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
11114219|NCT01667419|EG002|Reported Event|Cohort 2 Vemurafenib|Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
11114220|NCT01667419|EG003|Reported Event|Cohort 2 Placebo|Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
11114221|NCT01667432|BG000|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
11114222|NCT01667432|FG000|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
11114223|NCT01667432|OG000|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
11114224|NCT01667432|EG000|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
11114225|NCT01667471|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
11114226|NCT01667471|FG000|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg intravenously (IV) every 4 weeks up to 104 weeks or until tocilizumab was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA).
11114227|NCT01667471|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
11114228|NCT01667471|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
11114229|NCT01667471|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
11114230|NCT01667536|BG000|Baseline|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
11114231|NCT01667536|FG000|Participant Flow|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
11114232|NCT01667536|OG000|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
11114233|NCT01667536|OG000|Outcome|Drug: 99mTc-MIP-1404|20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
11114234|NCT01667536|OG000|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
11114235|NCT01667536|OG001|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
11114236|NCT01667536|EG000|Reported Event|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
11114237|NCT01667549|BG000|Baseline|1M0.5|"Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114238|NCT01667549|BG001|Baseline|1M1.5|"Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114239|NCT01667549|BG002|Baseline|1M2.5|"Mothers will receive the intervention for one month beginning when their infants are 2.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114240|NCT01667549|BG003|Baseline|3M0.5|"Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
10846056|NCT00272779|EG000|Reported Event|ATV/RTV/Tenofovir/Emtricitabine|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
11114241|NCT01667549|BG004|Baseline|Control|Mothers will not receive the intervention.
11114242|NCT01667549|BG005|Baseline|Total|Total of all reporting groups
11114243|NCT01667549|FG000|Participant Flow|1M0.5|"Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114244|NCT01667549|FG001|Participant Flow|1M1.5|"Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114245|NCT01667549|FG002|Participant Flow|1M2.5|Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
11114246|NCT01667549|FG003|Participant Flow|3M0.5|"Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114247|NCT01667549|FG004|Participant Flow|Control|Mothers will not receive the intervention.
11114248|NCT01667549|OG000|Outcome|1M0.5|"Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114249|NCT01667549|OG001|Outcome|1M1.5|"Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114250|NCT01667549|OG002|Outcome|1M2.5|Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
11114251|NCT01667549|OG003|Outcome|3M0.5|"Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114252|NCT01667549|OG004|Outcome|Control|Mothers will not receive the intervention.
11114253|NCT01667549|OG000|Outcome|1M0.5|"Mothers received the intervention for 1 month beginning when their infant was 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114254|NCT01667549|OG001|Outcome|1M1.5|"Mothers received the intervention for 1 month beginning when their infant was 1.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114255|NCT01667549|OG002|Outcome|1M2.5|"Mothers received the intervention for 1 month beginning when their infant was 2.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114256|NCT01667549|OG003|Outcome|3M0.5|"Mothers received the intervention for 3 months beginning when their infant was 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114257|NCT01667549|OG004|Outcome|Control|Mothers did not receive the intervention.
11114258|NCT01667549|EG000|Reported Event|1M0.5|"Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114259|NCT01667549|EG001|Reported Event|1M1.5|"Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114260|NCT01667549|EG002|Reported Event|1M2.5|Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
11114261|NCT01667549|EG003|Reported Event|3M0.5|"Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.~Intervention: Timing of Diet and Flavor Experience~Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience."
11114262|NCT01667549|EG004|Reported Event|Control|Mothers will not receive the intervention.
11114263|NCT01667562|BG000|Baseline|Baseline Population|Participants with advanced or metastatic NSCLC were tested for EGFR mutations and enrolled in the study.
11114264|NCT01667562|FG000|Participant Flow|Diagnostic Phase|Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study.
11114265|NCT01667562|FG001|Participant Flow|Erlotinib|Erlotinib was administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
11114266|NCT01667562|OG000|Outcome|Erlotinib|Erlotinib was administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
11114267|NCT01667562|OG000|Outcome|Diagnostic Phase|Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study.
10846057|NCT00272779|EG001|Reported Event|LPV/RTV/Tenofovir/Emtricitabine|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
11114268|NCT01667562|EG000|Reported Event|Erlotinib|Erlotinib was administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
11114269|NCT01667679|BG000|Baseline|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril.
11114270|NCT01667679|BG001|Baseline|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally.
11114271|NCT01667679|BG002|Baseline|Total|Total of all reporting groups
11114272|NCT01667679|FG000|Participant Flow|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period (TP) 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
11114273|NCT01667679|FG001|Participant Flow|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
11114274|NCT01667679|OG000|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
11114275|NCT01667679|OG001|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
11114276|NCT01667679|OG000|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
11114277|NCT01667679|OG001|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
11114278|NCT01667679|EG000|Reported Event|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
11114279|NCT01667679|EG001|Reported Event|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
11114280|NCT01667731|BG000|Baseline|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
11114281|NCT01667731|BG001|Baseline|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
11114282|NCT01667731|BG002|Baseline|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
11114283|NCT01667731|BG003|Baseline|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
11114284|NCT01667731|BG004|Baseline|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
11114285|NCT01667731|BG005|Baseline|Total|Total of all reporting groups
11114286|NCT01667731|FG000|Participant Flow|SOF+RBV 12 Wk GT 2 TN|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)
11114287|NCT01667731|FG001|Participant Flow|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
11114288|NCT01667731|FG002|Participant Flow|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)
11114289|NCT01667731|FG003|Participant Flow|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
11114290|NCT01667731|FG004|Participant Flow|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
11114291|NCT01667731|OG000|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
11114292|NCT01667731|OG001|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
11114293|NCT01667731|OG002|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
11114294|NCT01667731|OG003|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
11114295|NCT01667731|OG004|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
11114296|NCT01667731|OG000|Outcome|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
11114297|NCT01667731|OG001|Outcome|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
11114298|NCT01667731|OG002|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
11114299|NCT01667731|EG000|Reported Event|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
11114300|NCT01667731|EG001|Reported Event|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
11114301|NCT01667731|EG002|Reported Event|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
11114302|NCT01667796|BG000|Baseline|MS Subjects|Female subjects with MS
11114303|NCT01667796|BG001|Baseline|Healthy Controls|Female subjects without MS
11114304|NCT01667796|BG002|Baseline|Total|Total of all reporting groups
11114305|NCT01667796|FG000|Participant Flow|Multiple Sclerosis (MS) Subjects|MS patients
11114306|NCT01667796|FG001|Participant Flow|Healthy Controls|Healthy control subjects
11114307|NCT01667796|OG000|Outcome|MS Subjects|Female subjects with MS
11114308|NCT01667796|OG001|Outcome|Healthy Controls|Female subjects without MS
11114309|NCT01667796|OG000|Outcome|MS Subjects|MS patients
11114310|NCT01667796|OG001|Outcome|Healthy Controls|Healthy control subjects
11114311|NCT01667796|OG000|Outcome|Gene Expression: MS vs HC|Gene expression analyses have been cancelled as a secondary outcome as laboratory techniques developed since the original study was started indicated that whole blood gene expression is unlikely to be informative.
11114312|NCT01667796|OG000|Outcome|Multiple Sclerosis (MS) Subjects|MS patients
11114313|NCT01667796|EG000|Reported Event|MS Subjects|MS patients
11114314|NCT01667796|EG001|Reported Event|Healthy Controls|Healthy control subjects
11114315|NCT01667848|BG000|Baseline|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
11114316|NCT01667848|BG001|Baseline|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
11114317|NCT01667848|BG002|Baseline|Total|Total of all reporting groups
11114318|NCT01667848|FG000|Participant Flow|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
11114319|NCT01667848|FG001|Participant Flow|Group B: Insufflation With Warm Gas|Insufflation with warm gas during laparoscopic cholecystectomy
11114320|NCT01667848|OG000|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
11114321|NCT01667848|OG001|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
11114322|NCT01667848|EG000|Reported Event|Group A|Insufflation with cold gas during laparoscopic cholecystectomy
11114323|NCT01667848|EG001|Reported Event|Group B|Insufflation with warm gas during laparoscopic cholecystectomy
11114324|NCT01667900|BG000|Baseline|Part A-Healthy|Part A (single-dose, 3 treatment period, crossover design) involved overtly healthy participants only. Each participant received single doses of placebo and 2 of the 3 dulaglutide doses (0.5, 0.75, and 1.5 mg), in 3 treatment periods, such that placebo was administered SQ to all 16 participants and 0.5, 0.75, and 1.5 mg dulaglutide was administered SQ to 10, 11, and 11 participants, respectively. There was a washout period of at least 28 days between doses.
11114325|NCT01667900|BG001|Baseline|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114326|NCT01667900|BG002|Baseline|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114327|NCT01667900|BG003|Baseline|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114328|NCT01667900|BG004|Baseline|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114329|NCT01667900|BG005|Baseline|Total|Total of all reporting groups
11114330|NCT01667900|FG000|Participant Flow|First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ)~Period 2: placebo administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
11114331|NCT01667900|FG001|Participant Flow|First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
11114332|NCT01667900|FG002|Participant Flow|First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
11114333|NCT01667900|FG003|Participant Flow|First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
11114334|NCT01667900|FG004|Participant Flow|First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
11114335|NCT01667900|FG005|Participant Flow|First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
11114336|NCT01667900|FG006|Participant Flow|First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
11114337|NCT01667900|FG007|Participant Flow|First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
11114338|NCT01667900|FG008|Participant Flow|First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
11114339|NCT01667900|FG009|Participant Flow|First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
11114340|NCT01667900|FG010|Participant Flow|First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
11114341|NCT01667900|FG011|Participant Flow|First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
11114342|NCT01667900|FG012|Participant Flow|First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
11348324|NCT04184999|FG000|Participant Flow|Intracameral Dexamethasone + Postoperative Topical Prednisolone|"dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone~dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid~Prednisolone Acetate: topical ophthalmic drop for 3 weeks"
11114343|NCT01667900|FG013|Participant Flow|First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
11114344|NCT01667900|FG014|Participant Flow|First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
11114345|NCT01667900|FG015|Participant Flow|First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
11114346|NCT01667900|FG016|Participant Flow|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B
11114347|NCT01667900|FG017|Participant Flow|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114348|NCT01667900|FG018|Participant Flow|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114349|NCT01667900|FG019|Participant Flow|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114350|NCT01667900|OG000|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
11114351|NCT01667900|OG001|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
11114352|NCT01667900|OG002|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
11114353|NCT01667900|OG003|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114354|NCT01667900|OG004|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114355|NCT01667900|OG005|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114356|NCT01667900|OG000|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114357|NCT01667900|OG001|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114358|NCT01667900|OG002|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114359|NCT01667900|OG003|Outcome|Placebo (Part B-T2DM|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
11114360|NCT01667900|EG000|Reported Event|Placebo (Part A-Healthy)|"Placebo administered once SQ to healthy participants in 1 of 3 treatment periods~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
11114361|NCT01667900|EG001|Reported Event|0.5 mg Dulaglutide (Part A-Healthy)|"0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
11114362|NCT01667900|EG002|Reported Event|0.75 mg Dulaglutide (Part A-Healthy)|"0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
11114363|NCT01667900|EG003|Reported Event|1.5 mg Dulaglutide (Part A-Healthy)|"1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
11114364|NCT01667900|EG004|Reported Event|Placebo (Part B-T2DM)|"Placebo administered to participants with T2DM once weekly SQ for 4 weeks~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
11114365|NCT01667900|EG005|Reported Event|0.5 mg Dulaglutide (Part B-T2DM)|"0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
11114366|NCT01667900|EG006|Reported Event|0.75 mg Dulaglutide (Part B-T2DM)|"0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
11114367|NCT01667900|EG007|Reported Event|1.5 mg Dulaglutide (Part B-T2DM)|"1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
11114368|NCT01667926|BG000|Baseline|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
11114369|NCT01667926|BG001|Baseline|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
11114370|NCT01667926|BG002|Baseline|Total|Total of all reporting groups
11114371|NCT01667926|FG000|Participant Flow|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
11114372|NCT01667926|FG001|Participant Flow|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
11114373|NCT01667926|FG002|Participant Flow|Screen Fail/No Baseline|"Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria.~Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions."
11114374|NCT01667926|OG000|Outcome|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
11114375|NCT01667926|OG001|Outcome|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
11114376|NCT01667926|EG000|Reported Event|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
11114377|NCT01667926|EG001|Reported Event|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
11114378|NCT01667978|BG000|Baseline|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
11114379|NCT01667978|BG001|Baseline|Control|"o PI therapy, control group~Norethindrone acetate"
11114380|NCT01667978|BG002|Baseline|Total|Total of all reporting groups
11114381|NCT01667978|FG000|Participant Flow|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate~16 HIV positive on PI (atazanavir ritonavir 10, darunovir, lopinavir)"
11114382|NCT01667978|FG001|Participant Flow|Control|"no PI therapy, control group~Norethindrone acetate~17 controls (4 no ARV)"
11114383|NCT01667978|OG000|Outcome|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
11114384|NCT01667978|OG001|Outcome|Control|"o PI therapy, control group~Norethindrone acetate"
11114385|NCT01667978|EG000|Reported Event|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
11114386|NCT01667978|EG001|Reported Event|Control|"o PI therapy, control group~Norethindrone acetate"
11114387|NCT01668004|BG000|Baseline|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
11114388|NCT01668004|FG000|Participant Flow|GLM 50 mg|Golimumab (GLM) given subcutaneously at a dose of 50 mg once monthly for up to 12 months
11114389|NCT01668004|OG000|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
11114390|NCT01668004|OG001|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
11114391|NCT01668004|OG000|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
11114392|NCT01668004|EG000|Reported Event|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
11114393|NCT01668017|BG000|Baseline|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21- day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114394|NCT01668017|BG001|Baseline|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114395|NCT01668017|BG002|Baseline|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114396|NCT01668017|BG003|Baseline|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114397|NCT01668017|BG004|Baseline|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114398|NCT01668017|BG005|Baseline|Total|Total of all reporting groups
11114399|NCT01668017|FG000|Participant Flow|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 milligram (mg) twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114400|NCT01668017|FG001|Participant Flow|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114401|NCT01668017|FG002|Participant Flow|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114402|NCT01668017|FG003|Participant Flow|Part 1: Pimasertib 30 mg in Hepatocellular Carcinoma (HCC)|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114403|NCT01668017|FG004|Participant Flow|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114404|NCT01668017|OG000|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114405|NCT01668017|OG001|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11348325|NCT04184999|FG001|Participant Flow|Postoperative Topical Prednisolone|postoperative topical prednisolone for 3 weeks
11114406|NCT01668017|OG002|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
11114407|NCT01668017|OG003|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
11114408|NCT01668017|OG004|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
11114409|NCT01668017|OG002|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114410|NCT01668017|OG003|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114411|NCT01668017|OG004|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114412|NCT01668017|OG000|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114413|NCT01668017|OG003|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114414|NCT01668017|OG000|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114415|NCT01668017|OG000|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 milligram (mg) twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114416|NCT01668017|OG000|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114417|NCT01668017|OG001|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114418|NCT01668017|OG002|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114419|NCT01668017|OG002|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with HCC were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114420|NCT01668017|OG003|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114421|NCT01668017|OG004|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11348326|NCT04184999|OG000|Outcome|Intracameral Dexamethasone|intracameral dexamethasone + postoperative prednisolone acetate for 3 weeks
11348327|NCT04184999|OG001|Outcome|Postoperative Prednisolone Acetate|postoperative prednisolone acetate for 3 weeks
11114422|NCT01668017|OG000|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg twice a day (BID) until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114423|NCT01668017|OG003|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114424|NCT01668017|EG000|Reported Event|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114425|NCT01668017|EG001|Reported Event|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114426|NCT01668017|EG002|Reported Event|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11348328|NCT04184999|EG000|Reported Event|Intracameral Dexamethasone + Postoperative Prednisolone Acetate|intracameral dexamethasone 9% injection at the time of cataract surgery + standard postoperative prednisolone acetate regimen
11348329|NCT04184999|EG001|Reported Event|Postoperative Prednisolone Acetate Regimen|standard postoperative prednisolone acetate regimen
11348330|NCT04184271|BG000|Baseline|38% Silver Diamine Fluoride|"38% silver diamine fluoride, topical, 1 drop, single application~38% silver diamine fluoride: Topical application of SDF to teeth"
11348331|NCT04184271|FG000|Participant Flow|38% Silver Diamine Fluoride|"38% silver diamine fluoride, topical, 1 drop, single application~38% silver diamine fluoride: Topical application of SDF to teeth"
11114427|NCT01668017|EG003|Reported Event|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114428|NCT01668017|EG004|Reported Event|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
11114429|NCT01668030|BG000|Baseline|All Study Participants|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.~Enzymatic treatment versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
11114430|NCT01668030|FG000|Participant Flow|Bacitracin Treated Side of Face|Bacitractin was applied to one side of face.
11114431|NCT01668030|FG001|Participant Flow|Enzymatic Agent Treatment Side of Face|Enzymatic agent applied to cheek
11114432|NCT01668030|OG000|Outcome|Bacitracin Treated Side of Face|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.~Enzymatic agent versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
11114433|NCT01668030|OG001|Outcome|Enzymatic Agent Treatment Side of Face|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.~Enzymatic agent versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
11114434|NCT01668030|EG000|Reported Event|All Study Participants|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.~Enzymatic treatment versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
11114435|NCT01668173|BG000|Baseline|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
11114436|NCT01668173|FG000|Participant Flow|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
11114437|NCT01668173|OG000|Outcome|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
11114438|NCT01668173|EG000|Reported Event|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
11114439|NCT01668355|BG000|Baseline|SMI-PACT|Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model to coordinate and address physical health needs.
11114440|NCT01668355|BG001|Baseline|Usual Care|Usual Primary Care
11114441|NCT01668355|BG002|Baseline|Total|Total of all reporting groups
11114442|NCT01668355|FG000|Participant Flow|SMI-PACT|"Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).~An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness."
11114443|NCT01668355|FG001|Participant Flow|Usual Care|Usual Primary Care
11114444|NCT01668355|OG000|Outcome|SMI-PACT|"Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness~Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness."
11114445|NCT01668355|OG001|Outcome|Usual Care|Usual Primary Care
11114446|NCT01668355|OG000|Outcome|SMI-PACT|"Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).~An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness."
11114447|NCT01668355|EG000|Reported Event|SMI-PACT|Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model to coordinate and address physical health needs.
11114448|NCT01668355|EG001|Reported Event|Usual Care|Usual Primary Care
11114449|NCT01668537|BG000|Baseline|LF Formulation|"Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart~LF formulation of MVA-BN®"
11114450|NCT01668537|BG001|Baseline|FD Formulation|"Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart~FD formulation of MVA-BN®"
11114451|NCT01668537|BG002|Baseline|Total|Total of all reporting groups
11114452|NCT01668537|FG000|Participant Flow|LF Formulation|"Liquid Frozen (LF) formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, subcutaneous (s.c.), 4 weeks apart~LF formulation of MVA-BN®"
11114453|NCT01668537|FG001|Participant Flow|FD Formulation|"Freeze Dried (FD) formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart~FD formulation of MVA-BN®"
11114454|NCT01668537|OG000|Outcome|LF Formulation|"Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart~LF formulation of MVA-BN®"
11114455|NCT01668537|OG001|Outcome|FD Formulation|"Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart~FD formulation of MVA-BN®"
11114456|NCT01668537|EG000|Reported Event|LF Formulation|"Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart~LF formulation of MVA-BN®"
11114457|NCT01668537|EG001|Reported Event|FD Formulation|"Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart~FD formulation of MVA-BN®"
11114458|NCT01668589|BG000|Baseline|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114459|NCT01668589|BG001|Baseline|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114460|NCT01668589|BG002|Baseline|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114461|NCT01668589|BG003|Baseline|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114462|NCT01668589|BG004|Baseline|Total|Total of all reporting groups
11114463|NCT01668589|FG000|Participant Flow|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114464|NCT01668589|FG001|Participant Flow|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114465|NCT01668589|FG002|Participant Flow|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114466|NCT01668589|FG003|Participant Flow|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114467|NCT01668589|OG000|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114468|NCT01668589|OG001|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114469|NCT01668589|OG002|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114470|NCT01668589|OG003|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
11114471|NCT01668589|EG000|Reported Event|Germany|Prolia 60 mg SC Q6M
11114472|NCT01668589|EG001|Reported Event|Austria|Prolia 60 mg SC Q6M
11114473|NCT01668589|EG002|Reported Event|Greece|Prolia 60 mg SC Q6M
11114474|NCT01668589|EG003|Reported Event|Belgium|Prolia 60 mg SC Q6M
11114475|NCT01668602|BG000|Baseline|Cohort 1 - FastFES Training|Participants in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).
11114476|NCT01668602|BG001|Baseline|Cohort 2 - FastFES and Fast Walking|Participants in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking.
11114477|NCT01668602|BG002|Baseline|Total|Total of all reporting groups
11114478|NCT01668602|FG000|Participant Flow|Cohort 1 - FastFES Training|Participants with chronic stroke in Cohort 1 will receive 18 training sessions of fast walking on a treadmill plus Functional Electrical Stimulation (FastFES).
11114479|NCT01668602|FG001|Participant Flow|Cohort 2 - FastFES and Fast Walking|Participants with chronic stroke in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking on a treadmill.
11114480|NCT01668602|OG000|Outcome|Three Sessions of FastFES|Cohort 2 participants after having three sessions of FastFES
11114481|NCT01668602|OG001|Outcome|Three Sessions of Fast Walking|Cohort 2 participants after having three sessions of Fast Walking
11114482|NCT01668602|OG000|Outcome|FastFES Training|Participants in Cohort 1 receiving 18 sessions of FastFES Training.
11114483|NCT01668602|EG000|Reported Event|Cohort 1 - 18 Sessions of FastFES Training|Participants in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).
11114484|NCT01668602|EG001|Reported Event|Cohort 2 - Three Sessions of FastFES|Participants in Cohort 2 during training sessions of FastFES.
11114485|NCT01668602|EG002|Reported Event|Cohort 2 - Three Sessions of Fast Walking|Participants in Cohort 2 during training sessions of Fast Walking.
11114486|NCT01668628|BG000|Baseline|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dia;ysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
11114487|NCT01668628|BG001|Baseline|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
10848764|NCT00291447|BG002|Baseline|Cohort 3|"Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11114488|NCT01668628|BG002|Baseline|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
11114489|NCT01668628|BG003|Baseline|Total|Total of all reporting groups
11114490|NCT01668628|FG000|Participant Flow|Incident Peritoneal Dialysis(PD) Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
11114491|NCT01668628|FG001|Participant Flow|Prevalent Peritoneal Dialysis (PD) Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
11114492|NCT01668628|FG002|Participant Flow|Prevalent Hemodialysis (HD) Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
11114493|NCT01668628|OG000|Outcome|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
11114494|NCT01668628|OG001|Outcome|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
11114495|NCT01668628|OG002|Outcome|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
11114496|NCT01668628|OG000|Outcome|Normohydration Group|Peritoneal dialysis patients with baseline -2L<OH value <+2L
11114497|NCT01668628|OG001|Outcome|Overhydration Group|Peritoneal dialysis patients with baseline OH value >+2L
11114498|NCT01668628|OG000|Outcome|Normohydration Group|Hemodialysis patients with baseline -2L<OH value <+2L
11114499|NCT01668628|OG001|Outcome|Overhydration Group|Hemodialysis patients with baseline OH value >+2L
11114500|NCT01668628|EG000|Reported Event|Incident PD Patients|First treatment for ESRD by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is CAPD or APD and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
11114501|NCT01668628|EG001|Reported Event|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
11114502|NCT01668628|EG002|Reported Event|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
11114503|NCT01668654|BG000|Baseline|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
11114504|NCT01668654|FG000|Participant Flow|Retigabine/Ezogabine TID|Participants (par.) received retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams(mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
11114505|NCT01668654|OG000|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
11114506|NCT01668654|EG000|Reported Event|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability) over the course of this long-term open-label extension study. Physicians used their clinical judgment in making dose adjustments. Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
11114507|NCT01668667|BG000|Baseline|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
11114508|NCT01668667|BG001|Baseline|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
11114509|NCT01668667|BG002|Baseline|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
10846058|NCT00272792|BG000|Baseline|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
11114510|NCT01668667|BG003|Baseline|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
11114511|NCT01668667|BG004|Baseline|Total|Total of all reporting groups
11114512|NCT01668667|FG000|Participant Flow|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
11114513|NCT01668667|FG001|Participant Flow|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
11114514|NCT01668667|FG002|Participant Flow|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
11114515|NCT01668667|FG003|Participant Flow|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
11114516|NCT01668667|OG000|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
11114517|NCT01668667|OG001|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
11114518|NCT01668667|OG002|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
11114519|NCT01668667|OG003|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
11114520|NCT01668667|EG000|Reported Event|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
11114521|NCT01668667|EG001|Reported Event|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
11114522|NCT01668667|EG002|Reported Event|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
11114523|NCT01668667|EG003|Reported Event|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PMmatching placebo.
11114524|NCT01668797|BG000|Baseline|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
11114525|NCT01668797|BG001|Baseline|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
11114526|NCT01668797|BG002|Baseline|Total|Total of all reporting groups
11114527|NCT01668797|FG000|Participant Flow|Phase A (Conversion Phase)|The purpose of the open-label conversion phase was 2-fold: 1) to cross-titrate the participants current antipsychotic treatment to brexpiprazole monotherapy over a period of 1 to 4 weeks and 2) to allow washout of prohibited medications in preparation for the stabilization phase.
11114528|NCT01668797|FG001|Participant Flow|Phase B (Stabilization Phase)|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
11114529|NCT01668797|FG002|Participant Flow|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
11114530|NCT01668797|FG003|Participant Flow|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
11114531|NCT01668797|OG000|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
11114532|NCT01668797|OG001|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
11114533|NCT01668797|EG000|Reported Event|Single Blind Stabilization Phase|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
11114534|NCT01668797|EG001|Reported Event|Brexpiprazole (Double-blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
11114535|NCT01668797|EG002|Reported Event|Placebo (Double-blnd Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
11114536|NCT01668836|BG000|Baseline|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
11114537|NCT01668836|BG001|Baseline|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
11114538|NCT01668836|BG002|Baseline|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
11114539|NCT01668836|BG003|Baseline|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
11114540|NCT01668836|BG004|Baseline|Total|Total of all reporting groups
11114541|NCT01668836|FG000|Participant Flow|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
11114542|NCT01668836|FG001|Participant Flow|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
11114543|NCT01668836|FG002|Participant Flow|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
11114544|NCT01668836|FG003|Participant Flow|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
11114545|NCT01668836|OG000|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
11114546|NCT01668836|OG001|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
11114547|NCT01668836|OG002|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
11114548|NCT01668836|OG003|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
11114549|NCT01668836|OG000|Outcome|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
11114550|NCT01668836|OG001|Outcome|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
11114551|NCT01668836|OG002|Outcome|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
11114552|NCT01668836|OG003|Outcome|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
11114553|NCT01668836|OG002|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
11114554|NCT01668836|OG003|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
11114555|NCT01668836|EG000|Reported Event|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
11114556|NCT01668836|EG001|Reported Event|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
11114557|NCT01668836|EG002|Reported Event|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
11114558|NCT01668836|EG003|Reported Event|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
11114559|NCT01668966|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
11114560|NCT01668966|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) every 4 weeks for up to 104 weeks.
11114561|NCT01668966|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
11114562|NCT01668966|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
11114563|NCT01669096|BG000|Baseline|GSK 692342 Group|Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
11114564|NCT01669096|FG000|Participant Flow|GSK 692342 Group|Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
11114565|NCT01669096|OG000|Outcome|GSK 692342 Group|Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
11114566|NCT01669096|EG000|Reported Event|GSK 692342 Group|Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
11114567|NCT01669122|BG000|Baseline|Safety Population|Baseline measurements were performed for safety population which included all participants in the study who were dispensed at least one of the study treatment. Out of 40 randomized participants, one participant did not receive any treatment and was lost to follow-up.
11114568|NCT01669122|FG000|Participant Flow|Total Participants|
11114569|NCT01669122|OG000|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
11114570|NCT01669122|OG001|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
11114571|NCT01669122|OG002|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
11114572|NCT01669122|OG003|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
11114573|NCT01669122|OG000|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A was administered orally as a single dose treatment.
11114574|NCT01669122|EG000|Reported Event|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
11114575|NCT01669122|EG001|Reported Event|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
11114576|NCT01669122|EG002|Reported Event|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
11114577|NCT01669122|EG003|Reported Event|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
11114578|NCT01669174|BG000|Baseline|BYM338|30 mg/kg
10846059|NCT00272792|BG001|Baseline|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
11114579|NCT01669174|BG001|Baseline|Placebo|Placebo to BYM338 30mg/kg
11114580|NCT01669174|BG002|Baseline|Total|Total of all reporting groups
10846060|NCT00272792|BG002|Baseline|Total|Total of all reporting groups
11114581|NCT01669174|FG000|Participant Flow|BYM338|30 mg/kg
11114582|NCT01669174|FG001|Participant Flow|Placebo|Placebo to BYM338 30mg/kg
11114583|NCT01669174|OG000|Outcome|BYM338|30 mg/kg
11114584|NCT01669174|OG001|Outcome|Placebo|Placebo to BYM338 30mg/kg
11114585|NCT01669174|EG000|Reported Event|BYM338 30mg/kg|BYM338 30mg/kg
11114586|NCT01669174|EG001|Reported Event|Placebo|Placebo to BYM338 30mg/kg
11114587|NCT01669343|BG000|Baseline|Post-menopausal Women Using Adjuvant Letrozole|Part A: All patients enrolled, on standard of care letrozole; Part B: All patients with BMI>=25 who completed Part A, on a double dose of letrozole
11114588|NCT01669343|FG000|Participant Flow|Post-menopausal Women Using Adjuvant Letrozole|Part A: All patients enrolled, on standard of care letrozole; Part B: All patients with BMI>=25 who completed Part A, on a double dose of letrozole
11114589|NCT01669343|OG000|Outcome|Post-menopausal Women Using Adjuvant Letrozole|"Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants~Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period."
11114590|NCT01669343|OG000|Outcome|Post-menopausal Women Using Adjuvant Letrozole|"Part B Double Dose Letrozole in overweight/obese participants~Part B: In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period."
11114591|NCT01669343|OG000|Outcome|Post-menopausal Women Using Adjuvant Letrozole|Part A: All patients enrolled, on standard of care letrozole
11114592|NCT01669343|OG000|Outcome|Part B|Part B: Patients With BMI>=25, on double dose of letrozole
11114593|NCT01669343|EG000|Reported Event|Full Study|Adverse events collected during part A, 29 days of monitored adherence to standard of care letrozole and Part B .
11126718|NCT01734993|FG000|Participant Flow|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 long term extension (LTE) study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of greater than [>] 1.2 points) were administered tocilizumab (TCZ) in this long-term extension study, at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
11126719|NCT01734993|OG000|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
11348332|NCT04184271|OG000|Outcome|38% Silver Diamine Fluoride|"38% silver diamine fluoride, topical, 1 drop, single application~38% silver diamine fluoride: Topical application of SDF to teeth"
11348333|NCT04184271|EG000|Reported Event|38% Silver Diamine Fluoride|"38% silver diamine fluoride, topical, 1 drop, single application~38% silver diamine fluoride: Topical application of SDF to teeth"
11114594|NCT01669421|BG000|Baseline|Alpha-1 Antitrypsin (Human)|"Alpha-1 Antitrypsin (human) 120 mg per kg per week for 4 weeks~Alpha-1 Antitrypsin (human): Comparison of Zemaira (Alpha 1 Antitrypsin Human) 120 mg/kg/weekly for four weeks versus 2 phases with same drug administered at standard doses of 60 mg/kg/weekly for four weeks each"
11114595|NCT01669421|FG000|Participant Flow|Studied Population|All patients belong to one study arm. First they received standard dose augmentation therapy (60 mg/kg/week) x 4 weeks, then they receive experimental double dose (120 mg/kg/week) x 4 weeks and finally return to standard dose (60 mg/kg/week) for 4 additional weeks.
11114596|NCT01669421|OG000|Outcome|Alpha-1 Antitrypsin (Human) Standard Dose Baseline|Alpha-1 Antitrypsin (human) 60 mg per kg per week for 4 weeks. Study week 4
11114597|NCT01669421|OG001|Outcome|Alpha-1 Antitrypsin (Human) Double Dose|Alpha-1 Antitrypsin (human) 120 mg/kg per week for 4 weeks. Study week 8
11114598|NCT01669421|OG002|Outcome|Alpha-1 Antitrypsin (Human) Standard Dose|4 weeks on A1PI at 60 mg/kg per week after the other 2 phases. Collected@ study week 12
11114599|NCT01669421|OG000|Outcome|Alpha-1 Antitrypsin (Human) Standard Dose Baseline|Alpha-1 Antitrypsin (human) 60 mg per kg per week for 4 weeks
11114600|NCT01669421|OG001|Outcome|Alpha-1 Antitrypsin (Human) Double Dose|A1PI at 120 mg/kg per week for 4 weeks after subjects received 4 weeks standard dose
11114601|NCT01669421|OG002|Outcome|Alpha-1 Antitrypsin (Human) Standard Dose|60 mg/kg per week after the prior 2 phases
11114602|NCT01669421|OG000|Outcome|Alpha-1 Antitrypsin (Human) Standard Dose Baseline|Alpha-1 Antitrypsin (human) 60 mg/kg per week for 4 weeks (measure at week 4)
11114603|NCT01669421|OG001|Outcome|Alpha-1 Antitrypsin (Human) Double Dose|A1PI at 120 mg/kg per week x 4 weeks (measure at week 8)
11114604|NCT01669421|OG002|Outcome|Alpha-1 Antitrypsin (Human) Standard Dose|A1PI at 60 mg/kg per week after double dose (measured at week 12)
11114605|NCT01669421|EG000|Reported Event|Phase 1: Standard Dose|Standard dose (60 mg/kg/week) Weeks1-4
11114606|NCT01669421|EG001|Reported Event|Phase 2: Double Dose|Double dose (120 mg/kg/week) weeks 4-8
11114607|NCT01669421|EG002|Reported Event|Phase 3: Standard Dose|Standard dose (60 mg/kg/week) weeks 8-12
11114608|NCT01669434|BG000|Baseline|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
11114609|NCT01669434|BG001|Baseline|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
11114610|NCT01669434|BG002|Baseline|Total|Total of all reporting groups
11114611|NCT01669434|FG000|Participant Flow|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or day before surgery, whenever the last preoperative dose would normally occur."
11114612|NCT01669434|FG001|Participant Flow|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
11114613|NCT01669434|OG000|Outcome|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
11114614|NCT01669434|OG001|Outcome|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
11114615|NCT01669434|EG000|Reported Event|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
11114616|NCT01669434|EG001|Reported Event|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
11114617|NCT01669538|BG000|Baseline|Galantamine|"Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.~Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.~Galantamine"
11114618|NCT01669538|BG001|Baseline|Placebo|"Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.~Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.~Placebo"
11114619|NCT01669538|BG002|Baseline|Total|Total of all reporting groups
11126720|NCT01734993|OG000|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
11114620|NCT01669538|FG000|Participant Flow|Galantamine|"Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.~Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.~Galantamine"
11114621|NCT01669538|FG001|Participant Flow|Placebo|"Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.~Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.~Placebo"
11114622|NCT01669538|OG000|Outcome|Galantamine|"Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.~Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.~Galantamine"
11114623|NCT01669538|OG001|Outcome|Placebo|"Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.~Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.~Placebo"
11114624|NCT01669538|EG000|Reported Event|Galantamine|"Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.~Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.~Galantamine"
11114625|NCT01669538|EG001|Reported Event|Placebo|"Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.~Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.~Placebo"
11114626|NCT01669577|BG000|Baseline|Severe Trauma Patients|Hypotensive Patients (SBP<90mmHg), severe TBI, high energy traumas All patients must have calculated ISS >15 to be included and a written informed consent should be available
11114627|NCT01669577|FG000|Participant Flow|Severe Trauma Patients|"intervention : analysis of blood samples~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR collection of vital signs, blood chemistry; severity scores and intensive care unit(ICU) LOS(length of stay) were recorded"
11114628|NCT01669577|OG000|Outcome|Severe Trauma Patients|"intervention : analysis of blood samples; vital signs and clinical outcomes recorded~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
11114629|NCT01669577|EG000|Reported Event|Severe Trauma Patients|"intervention : analysis of blood samples~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
11114630|NCT01669603|BG000|Baseline|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
11114631|NCT01669603|BG001|Baseline|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
11114632|NCT01669603|BG002|Baseline|Total|Total of all reporting groups
11114633|NCT01669603|FG000|Participant Flow|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
11114634|NCT01669603|FG001|Participant Flow|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
11114635|NCT01669603|OG000|Outcome|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
11114636|NCT01669603|OG001|Outcome|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
11114637|NCT01669603|EG000|Reported Event|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
11114638|NCT01669603|EG001|Reported Event|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
11114639|NCT01669629|BG000|Baseline|All Subjects|All subjects who were enrolled in the study.
11114640|NCT01669629|FG000|Participant Flow|Delefilcon A \ Etafilcon A|"6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear~delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.~etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
11114641|NCT01669629|FG001|Participant Flow|Etafilcon A \ Delefilcon A|"6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear~delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.~etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
11114642|NCT01669629|OG000|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
11114643|NCT01669629|OG001|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
11114644|NCT01669629|EG000|Reported Event|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
11114645|NCT01669629|EG001|Reported Event|Etafilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
11114646|NCT01669642|BG000|Baseline|Fracture Reduction Group 2-5 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114647|NCT01669642|BG001|Baseline|Fracture Reduction Group 6-11 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114648|NCT01669642|BG002|Baseline|Fracture Reduction Group 12-17 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114649|NCT01669642|BG003|Baseline|Abscess Drainage Group 2-5 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114650|NCT01669642|BG004|Baseline|Abscess Drainage Group 6-11 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
10848765|NCT00291447|BG003|Baseline|Cohort 4|"Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11114651|NCT01669642|BG005|Baseline|Total|Total of all reporting groups
11114652|NCT01669642|FG000|Participant Flow|Fracture Reduction Group 2-5 Years|children between 2-5 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.
11114653|NCT01669642|FG001|Participant Flow|Fracture Reduction Group 6-11 Years|children between 6-11 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.
11114654|NCT01669642|FG002|Participant Flow|Fracture Reduction Group 12-17 Years|children between 12-17 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.
11114655|NCT01669642|FG003|Participant Flow|Abscess Drainage Group 2-5 Years|children between 2-5 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.
11114656|NCT01669642|FG004|Participant Flow|Abscess Drainage Group 6-11 Years|children between 6-11 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.
11114657|NCT01669642|FG005|Participant Flow|Abscess Drainage Group 12-17 Years|children between 12-17 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.
11114658|NCT01669642|OG000|Outcome|Fracture Reduction Group 2-5 Years|children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
11114659|NCT01669642|OG001|Outcome|Fracture Reduction Group 6-11 Years|children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
11114660|NCT01669642|OG002|Outcome|Fracture Reduction Group 12-17 Years|children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
11114661|NCT01669642|OG003|Outcome|Abscess Drainage Group 2-5 Years|children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
11114662|NCT01669642|OG004|Outcome|Abscess Drainage Group 6-11 Years|children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
11114663|NCT01669642|OG000|Outcome|Fracture Reduction Group 2-5 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114664|NCT01669642|OG001|Outcome|Fracture Reduction Group 6-11 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114665|NCT01669642|OG002|Outcome|Fracture Reduction Group 12-17 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114666|NCT01669642|OG003|Outcome|Abscess Drainage Group 2-5 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114667|NCT01669642|OG004|Outcome|Abscess Drainage Group 6-11 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114668|NCT01669642|EG000|Reported Event|Fracture Reduction Group 2-5 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114669|NCT01669642|EG001|Reported Event|Fracture Reduction Group 6-11 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114670|NCT01669642|EG002|Reported Event|Fracture Reduction Group 12-17 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114671|NCT01669642|EG003|Reported Event|Abscess Drainage Group 2-5 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114672|NCT01669642|EG004|Reported Event|Abscess Drainage Group 6-11 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
11114673|NCT01669720|BG000|Baseline|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
11114674|NCT01669720|BG001|Baseline|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
11114675|NCT01669720|BG002|Baseline|Total|Total of all reporting groups
11114676|NCT01669720|FG000|Participant Flow|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
11114677|NCT01669720|FG001|Participant Flow|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
11114678|NCT01669720|OG000|Outcome|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
11114679|NCT01669720|OG001|Outcome|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
11114680|NCT01669720|EG000|Reported Event|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
11114681|NCT01669720|EG001|Reported Event|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
11114682|NCT01669785|BG000|Baseline|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin. Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114683|NCT01669785|BG001|Baseline|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114684|NCT01669785|BG002|Baseline|Group C|NUPRO Classic Prophy Paste.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.Leave in contact for 60 seconds, rinse with water and expectorate.
11114685|NCT01669785|BG003|Baseline|Total|Total of all reporting groups
11114686|NCT01669785|FG000|Participant Flow|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114687|NCT01669785|FG001|Participant Flow|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114688|NCT01669785|FG002|Participant Flow|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
10848766|NCT00291447|BG004|Baseline|Total|Total of all reporting groups
11114689|NCT01669785|OG000|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114690|NCT01669785|OG001|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114691|NCT01669785|OG002|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
10848767|NCT00291447|FG000|Participant Flow|Cohort 1|"Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11114692|NCT01669785|OG000|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114693|NCT01669785|EG000|Reported Event|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114694|NCT01669785|EG001|Reported Event|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
11114695|NCT01669785|EG002|Reported Event|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
11114696|NCT01669798|BG000|Baseline|BIBF 1120|"BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.~BIBF 1120: PO 200mg BID"
11114697|NCT01669798|FG000|Participant Flow|BIBF 1120|"BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.~BIBF 1120: PO 200mg BID"
11114698|NCT01669798|OG000|Outcome|BIBF 1120|"BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.~BIBF 1120: PO 200mg BID"
11114699|NCT01669798|EG000|Reported Event|BIBF 1120|"BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.~BIBF 1120: PO 200mg BID"
11114700|NCT01669811|BG000|Baseline|D961H 20 mg BID|D961H 20 mg twice Daily
11114701|NCT01669811|BG001|Baseline|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
11114702|NCT01669811|BG002|Baseline|Total|Total of all reporting groups
11114703|NCT01669811|FG000|Participant Flow|D961H 20 mg BID|Hard capsule containing 22.3 mg of D961H as enteric coated pellets
11114704|NCT01669811|FG001|Participant Flow|D961H 20 mg QD + Placebo|Hard capsule unidentifiable to D961H capsule 20 mg
11114705|NCT01669811|OG000|Outcome|D961H 20mg Bid|D961H 20mg twice daily
11114706|NCT01669811|OG001|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
11114707|NCT01669811|EG000|Reported Event|D961H 20 mg BID|D961H 20 mg twice Daily
11114708|NCT01669811|EG001|Reported Event|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
11114709|NCT01669863|BG000|Baseline|Use of ECMO in Non-intubated Patients|ECMO group
11114710|NCT01669863|FG000|Participant Flow|Use of ECMO in Non-intubated Patients|"ECMO used in non-intubated patients with ARDS~ECMO~ECMO in non-intubated patients"
11114711|NCT01669863|OG000|Outcome|Use of ECMO in Non-intubated Patients|"ECMO will be used in non-intubated patients with ARDS~ECMO~ECMO in non-intubated patients"
11114712|NCT01669863|OG000|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
11114713|NCT01669863|EG000|Reported Event|Use of ECMO in Non-intubated Patients|Patients on ECMO
11114714|NCT01669902|BG000|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
11114715|NCT01669902|FG000|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
11114716|NCT01669902|OG000|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
11114717|NCT01669902|EG000|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
11114718|NCT01669928|BG000|Baseline|Morning Medication, Then Evening|"Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, then cross over to antihypertensive medication in the evening (between 18.00 and 23.00) for 6 months.~Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication."
11114719|NCT01669928|BG001|Baseline|Evening Medication, Then Morning|"Anti hypertensive medication in the evening (between 18.00 and 23.00) for 6 months, then cross over to antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months,~Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication."
11114720|NCT01669928|BG002|Baseline|Total|Total of all reporting groups
11114721|NCT01669928|FG000|Participant Flow|Morning Medication, Then Evening|"Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, then cross over to antihypertensive medication in the evening (between 18.00 and 23.00) for 6 months.~Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication."
11114722|NCT01669928|FG001|Participant Flow|Evening Medication, Then Morning|"Anti hypertensive medication in the evening (between 18.00 and 23.00) for 6 months, then cross over to antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months,~Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication."
11114723|NCT01669928|OG000|Outcome|Morning Medication|Antihypertensive medication in the morning (between 06.00 and 11.00)
11114724|NCT01669928|OG001|Outcome|Evening Medication|Anti hypertensive medication in the evening (between 18.00 and 23.00)
11114725|NCT01669928|OG000|Outcome|Morning Medication|"Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months~Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication."
11114726|NCT01669928|OG001|Outcome|Evening Medication|"Anti hypertensive medication in the evening~Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication."
11114727|NCT01669928|EG000|Reported Event|Morning Medication|Antihypertensive medication in the morning (between 06.00 and 11.00)
11114728|NCT01669928|EG001|Reported Event|Evening Medication|Anti hypertensive medication in the evening (between 18.00 and 23.00)
11114729|NCT01670019|BG000|Baseline|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
11114730|NCT01670019|BG001|Baseline|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
11114731|NCT01670019|BG002|Baseline|Total|Total of all reporting groups
11114732|NCT01670019|FG000|Participant Flow|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
11348334|NCT04183231|BG000|Baseline|Anti-caries Varnish|"topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application~Anti-caries varnish: topical tooth varnish"
11114733|NCT01670019|FG001|Participant Flow|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
11114734|NCT01670019|OG000|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
11114735|NCT01670019|OG001|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
11114736|NCT01670019|EG000|Reported Event|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
11114737|NCT01670019|EG001|Reported Event|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
11114738|NCT01670045|BG000|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
11114739|NCT01670045|FG000|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
11114740|NCT01670045|OG000|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
11114741|NCT01670045|EG000|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA and the DAS28 joint scores who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
11114742|NCT01670097|BG000|Baseline|Intervention Group (Dexamethasone)|Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
11114743|NCT01670097|BG001|Baseline|Controlled Group (Placebo)|Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
11114744|NCT01670097|BG002|Baseline|Total|Total of all reporting groups
11114745|NCT01670097|FG000|Participant Flow|Intervention Group (Dexamethasone)|Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
11114746|NCT01670097|FG001|Participant Flow|Controlled Group (Placebo)|Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
11114747|NCT01670097|OG000|Outcome|Intervention Group (Dexamethasone)|Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
11114748|NCT01670097|OG001|Outcome|Controlled Group (Placebo)|Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
11114749|NCT01670097|EG000|Reported Event|Intervention Group (Dexamethasone)|Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
11114750|NCT01670097|EG001|Reported Event|Controlled Group (Placebo)|Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
11114751|NCT01670110|BG000|Baseline|Pasireotide LAR (SOM230)|"Active Pasireotide LAR~Pasireotide LAR: Injectible, 60mg per month"
11114752|NCT01670110|BG001|Baseline|Placebo Injection|Placebo: To be injected once per month
11114753|NCT01670110|BG002|Baseline|Total|Total of all reporting groups
11114754|NCT01670110|FG000|Participant Flow|Pasireotide LAR (SOM230)|"Active Pasireotide LAR~Pasireotide LAR: Injectible, 60mg per month"
11114755|NCT01670110|FG001|Participant Flow|Placebo Injection|Placebo: To be injected once per month
11114756|NCT01670110|OG000|Outcome|Pasireotide LAR (SOM230)|"Active Pasireotide LAR~Pasireotide LAR: Injectible, 60mg per month"
11114757|NCT01670110|OG001|Outcome|Placebo Injection|Placebo: To be injected once per month
11114758|NCT01670110|EG000|Reported Event|Pasireotide LAR (SOM230)|"Active Pasireotide LAR~Pasireotide LAR: Injectible, 60mg per month"
11114759|NCT01670110|EG001|Reported Event|Placebo Injection|Placebo: To be injected once per month
11114760|NCT01670188|BG000|Baseline|Pneumatic SCD|Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
11114761|NCT01670188|BG001|Baseline|Non-SCD Group|Patients enrolled in this group received standard care.
11114762|NCT01670188|BG002|Baseline|Total|Total of all reporting groups
11114763|NCT01670188|FG000|Participant Flow|Pneumatic SCD|Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
11114764|NCT01670188|FG001|Participant Flow|Non-SCD Group|Patients enrolled in this group received standard care.
11114765|NCT01670188|OG000|Outcome|Pneumatic SCD|Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
11114766|NCT01670188|OG001|Outcome|Non-SCD Group|Patients enrolled in this group received standard care.
11114767|NCT01670188|EG000|Reported Event|Pneumatic SCD|Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
11114768|NCT01670188|EG001|Reported Event|Non-SCD Group|Patients enrolled in this group received standard care.
11114769|NCT01670201|BG000|Baseline|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
11114770|NCT01670201|FG000|Participant Flow|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
11114771|NCT01670201|OG000|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
11114772|NCT01670201|EG000|Reported Event|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
11114773|NCT01670279|BG000|Baseline|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
11114774|NCT01670279|BG001|Baseline|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
11114775|NCT01670279|BG002|Baseline|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
11114776|NCT01670279|BG003|Baseline|Total|Total of all reporting groups
11114777|NCT01670279|FG000|Participant Flow|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
11114778|NCT01670279|FG001|Participant Flow|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
11114779|NCT01670279|FG002|Participant Flow|Brexpiprazole-Cohort 3|In the titration phase, participants were to receive 0.5 mg brexpiprazole or placebo QD for 7 days, followed by 1 mg brexpiprazole or placebo QD for 7 days, and then 2 mg brexpiprazole or placebo QD for 7 days. In the fixed dose phase, participants were to receive 3 mg brexpiprazole or placebo QD for 14 days. However, Cohort 3 was not conducted due to safety and tolerability results from Cohorts 1 and 2.
10846061|NCT00272792|FG000|Participant Flow|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
11114780|NCT01670279|FG003|Participant Flow|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
11114781|NCT01670279|OG000|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
11114782|NCT01670279|OG001|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
11114783|NCT01670279|OG002|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
11114784|NCT01670279|EG000|Reported Event|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
11114785|NCT01670279|EG001|Reported Event|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
11114786|NCT01670279|EG002|Reported Event|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
11114787|NCT01670292|BG000|Baseline|Experimental: HVLA-SM|"Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
11114788|NCT01670292|FG000|Participant Flow|Experimental: HVLA-SM|"Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation~Participants receive treatments of HVLA-SM to the lumbar spine in the side-lying position. Treatment frequency is twice per week for 6 weeks."
11114789|NCT01670292|OG000|Outcome|Experimental: HVLA-SM|"Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
10878620|NCT00453388|BG000|Baseline|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878621|NCT00453388|BG001|Baseline|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878622|NCT00453388|BG002|Baseline|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878623|NCT00453388|BG003|Baseline|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878624|NCT00453388|BG004|Baseline|Total|Total of all reporting groups
10878625|NCT00453388|FG000|Participant Flow|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878626|NCT00453388|FG001|Participant Flow|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878627|NCT00453388|FG002|Participant Flow|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878628|NCT00453388|FG003|Participant Flow|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10879543|NCT00458406|FG000|Participant Flow|Bi-Flex|"Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study. Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.~Of the N=56 assessed subjects, N=43 were enrolled into the Bi-Flex arm."
11004961|NCT01078246|EG002|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
11004962|NCT01078298|BG000|Baseline|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
11004963|NCT01078298|BG001|Baseline|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
11004964|NCT01078298|BG002|Baseline|Total|Total of all reporting groups
11004965|NCT01078298|FG000|Participant Flow|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
11004966|NCT01078298|FG001|Participant Flow|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
11004967|NCT01078298|OG000|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
11004968|NCT01078298|OG001|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
11004969|NCT01078298|EG000|Reported Event|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
11004970|NCT01078298|EG001|Reported Event|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
11004971|NCT01078363|BG000|Baseline|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
11004972|NCT01078363|BG001|Baseline|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
11004973|NCT01078363|BG002|Baseline|Total|Total of all reporting groups
11004974|NCT01078363|FG000|Participant Flow|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
11004975|NCT01078363|FG001|Participant Flow|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
11004976|NCT01078363|OG000|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
11004977|NCT01078363|OG001|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
11004978|NCT01078363|OG000|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril: Use of a ACE ( angiotension converting enzyme) inhibitors post heart Transplant for Blood pressure control."
11004979|NCT01078363|OG001|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~Placebo: Use of a placebo post heart Transplant for Blood pressure control."
11004980|NCT01078363|EG000|Reported Event|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
11004981|NCT01078363|EG001|Reported Event|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
11007861|NCT01093482|EG000|Reported Event|Mechanically Ventilated Patients|"Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.~Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour."
11007862|NCT01093521|BG000|Baseline|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
11007863|NCT01093521|FG000|Participant Flow|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
11004982|NCT01078376|BG000|Baseline|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
11004983|NCT01078376|BG001|Baseline|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
11004984|NCT01078376|BG002|Baseline|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
11004985|NCT01078376|BG003|Baseline|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
11004986|NCT01078376|BG004|Baseline|Total|Total of all reporting groups
11004987|NCT01078376|FG000|Participant Flow|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
11004988|NCT01078376|FG001|Participant Flow|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
11004989|NCT01078376|FG002|Participant Flow|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
11004990|NCT01078376|FG003|Participant Flow|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
11004991|NCT01078376|OG000|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
11004992|NCT01078376|OG001|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
11004993|NCT01078376|OG002|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
11004994|NCT01078376|OG003|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
11004995|NCT01078376|OG004|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
11004996|NCT01078376|OG005|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
11004997|NCT01078376|OG006|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
11004998|NCT01078376|EG000|Reported Event|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
11004999|NCT01078376|EG001|Reported Event|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
11005000|NCT01078376|EG002|Reported Event|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
11005001|NCT01078376|EG003|Reported Event|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
11005002|NCT01078389|BG000|Baseline|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
11005003|NCT01078389|BG001|Baseline|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
11005004|NCT01078389|BG002|Baseline|Total|Total of all reporting groups
11005005|NCT01078389|FG000|Participant Flow|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
11005006|NCT01078389|FG001|Participant Flow|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
11005007|NCT01078389|OG000|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
11005008|NCT01078389|OG001|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
11005009|NCT01078389|EG000|Reported Event|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
11005010|NCT01078389|EG001|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
11005011|NCT01078402|BG000|Baseline|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
11005012|NCT01078402|BG001|Baseline|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
11005013|NCT01078402|BG002|Baseline|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
11005014|NCT01078402|BG003|Baseline|Total|Total of all reporting groups
11005015|NCT01078402|FG000|Participant Flow|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
11005016|NCT01078402|FG001|Participant Flow|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
11005017|NCT01078402|FG002|Participant Flow|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
11005018|NCT01078402|OG000|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
11005019|NCT01078402|OG000|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
11005020|NCT01078402|OG001|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
11005021|NCT01078402|OG001|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
11005022|NCT01078402|OG002|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
11005023|NCT01078402|OG003|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
11005024|NCT01078402|EG000|Reported Event|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
10846062|NCT00272792|FG001|Participant Flow|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
11005025|NCT01078402|EG001|Reported Event|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
11005026|NCT01078402|EG002|Reported Event|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
11005027|NCT01078402|EG003|Reported Event|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
11005028|NCT01078441|BG000|Baseline|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
11005029|NCT01078441|FG000|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
11005030|NCT01078441|OG000|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
11005031|NCT01078441|EG000|Reported Event|Combination Chemotherapy|Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
11005032|NCT01078545|BG000|Baseline|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
11005033|NCT01078545|FG000|Participant Flow|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
11005034|NCT01078545|OG000|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
11005035|NCT01078545|EG000|Reported Event|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
11005036|NCT01078558|BG000|Baseline|Participants With RA|Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005037|NCT01078558|BG001|Baseline|Participants With PsA|Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005038|NCT01078558|BG002|Baseline|Participants With AS|Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005039|NCT01078558|BG003|Baseline|Total|Total of all reporting groups
11005040|NCT01078558|FG000|Participant Flow|Participants With RA|Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005041|NCT01078558|FG001|Participant Flow|Participants With PsA|Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005042|NCT01078558|FG002|Participant Flow|Participants With AS|Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005043|NCT01078558|OG000|Outcome|Participants With RA|Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005044|NCT01078558|OG001|Outcome|Participants With PsA|Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005045|NCT01078558|OG002|Outcome|Participants With AS|Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005046|NCT01078558|OG000|Outcome|Participants With PsA|Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005047|NCT01078558|OG000|Outcome|Participants With AS|Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005048|NCT01078558|EG000|Reported Event|All Participants|Participants diagnosed with RA, PsA or AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
11005049|NCT01078571|BG000|Baseline|Adalimumab (Humira)|
11005050|NCT01078571|FG000|Participant Flow|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
11005051|NCT01078571|OG000|Outcome|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
11005052|NCT01078571|OG000|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
11005053|NCT01078571|OG001|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
11005054|NCT01078571|OG001|Outcome|Adalimumab (Treatment for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
11005055|NCT01078571|OG000|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time four months or less before the baseline visit were classified as de novo participants."
11005056|NCT01078571|OG001|Outcome|Adalimumab (Treated for Greater Than 4 Months|Participants who had been taking adalimumab for 4 months or longer.
11005057|NCT01078571|EG000|Reported Event|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
11005058|NCT01078584|BG000|Baseline|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005059|NCT01078584|FG000|Participant Flow|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005060|NCT01078584|OG000|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005061|NCT01078584|OG001|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005062|NCT01078584|OG000|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005063|NCT01078584|OG001|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
11005064|NCT01078584|OG002|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
11005065|NCT01078584|OG000|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005066|NCT01078584|OG000|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005067|NCT01078584|OG000|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
11005068|NCT01078584|OG002|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005069|NCT01078584|OG003|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
11005070|NCT01078584|OG000|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
11005071|NCT01078584|OG001|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
11005072|NCT01078584|OG003|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
11007864|NCT01093521|OG000|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day"
11005073|NCT01078584|OG001|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
11005074|NCT01078584|EG000|Reported Event|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
11005075|NCT01078623|BG000|Baseline|Overall Study Population|All patients randomized into the study
11005076|NCT01078623|FG000|Participant Flow|Sequence 1|FDC 200/6 μg - FDC 200/12 μg - Aclidinium 200 μg - Formoterol 12 μg
11005077|NCT01078623|FG001|Participant Flow|Sequence 2|FDC 200/12 - Aclidinium 200 - Formoterol 12 - Placebo
11005078|NCT01078623|FG002|Participant Flow|Sequence 3|Aclidinium 200 - Formoterol 12 - Placebo - FDC 200/6
11005079|NCT01078623|FG003|Participant Flow|Sequence 4|Formoterol 12 - Placebo - FDC 200/6 - FDC 200/12
11005080|NCT01078623|FG004|Participant Flow|Sequence 5|Placebo - FDC 200/6 - FDC 200/12 - Aclidinium 200
11005081|NCT01078623|FG005|Participant Flow|Sequence 6|FDC 200/6 - Aclidinium 200 - Placebo - FDC 200/12
11005082|NCT01078623|FG006|Participant Flow|Sequence 7|FDC 200/12 - Formoterol 12 - FDC 200/6 - Aclidinium 200
11005083|NCT01078623|FG007|Participant Flow|Sequence 8|Aclidinium 200 - Placebo - FDC 200/12 - Formoterol 12
11005084|NCT01078623|FG008|Participant Flow|Sequence 9|Formoterol 12 - FDC 200/6 - Aclidinium 200 - Placebo
11005085|NCT01078623|FG009|Participant Flow|Sequence 10|Placebo - FDC 200/12 - Formoterol 12 - FDC 200/6
11005086|NCT01078623|FG010|Participant Flow|Sequence 11|FDC 200/6 - Formoterol 12 - FDC 200/12 - Placebo
11005087|NCT01078623|FG011|Participant Flow|Sequence 12|FDC 200/12 - Placebo - Aclidinium 200 - FDC 200/6
11005088|NCT01078623|FG012|Participant Flow|Sequence 13|Aclidinium 200 - FDC 200/6 - Formoterol 12 - FDC 200/12
11005089|NCT01078623|FG013|Participant Flow|Sequence 14|Formoterol 12 - FDC 200/12 - Placebo - Aclidinium 200
11005090|NCT01078623|FG014|Participant Flow|Sequence 15|Placebo - Aclidinium 200 - FDC 200/6 - Formoterol 12
11005091|NCT01078623|FG015|Participant Flow|Sequence 16|FDC 200/6 - Placebo - Formoterol 12 - Aclidinium 200
11005092|NCT01078623|FG016|Participant Flow|Sequence 17|FDC 200/12 - FDC 200/6 - Placebo - Formoterol 12
11005093|NCT01078623|FG017|Participant Flow|Sequence 18|Aclidinium 200 - FDC 200/12 - FDC 200/6 - Placebo
11005094|NCT01078623|FG018|Participant Flow|Sequence 19|Formoterol 12 - Aclidinium 200 - FDC 200/12 - FDC 200/6
11005095|NCT01078623|FG019|Participant Flow|Sequence 20|Placebo - Formoterol 12 - Aclidinium 200 - FDC 200/12
11005096|NCT01078623|OG000|Outcome|Placebo|Placebo twice daily
11005097|NCT01078623|OG001|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
11005098|NCT01078623|OG002|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
11005099|NCT01078623|OG003|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
11005100|NCT01078623|OG004|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
11005101|NCT01078623|EG000|Reported Event|Placebo|Placebo twice daily
11005102|NCT01078623|EG001|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
11005103|NCT01078623|EG002|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
11005104|NCT01078623|EG003|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
11005105|NCT01078623|EG004|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
11005106|NCT01078675|BG000|Baseline|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
11005107|NCT01078675|BG001|Baseline|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
11005108|NCT01078675|BG002|Baseline|Total|Total of all reporting groups
11005109|NCT01078675|FG000|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
11005110|NCT01078675|FG001|Participant Flow|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
11005111|NCT01078675|OG000|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
11005112|NCT01078675|OG000|Outcome|Rosuvastatin|Rosuvastatin 10 mg
11005113|NCT01078675|OG001|Outcome|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
11005114|NCT01078675|EG000|Reported Event|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
11005115|NCT01078753|BG000|Baseline|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
11005116|NCT01078753|BG001|Baseline|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
11005117|NCT01078753|BG002|Baseline|Total|Total of all reporting groups
11005118|NCT01078753|FG000|Participant Flow|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
11005119|NCT01078753|FG001|Participant Flow|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
11005120|NCT01078753|OG000|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
11005121|NCT01078753|OG001|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
11005122|NCT01078753|EG000|Reported Event|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
11005123|NCT01078753|EG001|Reported Event|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
11005124|NCT01078805|BG000|Baseline|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
11005125|NCT01078805|FG000|Participant Flow|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
11005126|NCT01078805|OG000|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
11005127|NCT01078805|EG000|Reported Event|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
11005128|NCT01078909|BG000|Baseline|300mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
11005129|NCT01078909|BG001|Baseline|600mg Fish Oil (EPA+DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
11005130|NCT01078909|BG002|Baseline|900mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 65 month supplementation period
11005131|NCT01078909|BG003|Baseline|1800mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
11005132|NCT01078909|BG004|Baseline|Placebo|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
11005133|NCT01078909|BG005|Baseline|Total|Total of all reporting groups
11005134|NCT01078909|FG000|Participant Flow|300mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
11005135|NCT01078909|FG001|Participant Flow|600mg Fish Oil (EPA+DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
11005136|NCT01078909|FG002|Participant Flow|900mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
11005137|NCT01078909|FG003|Participant Flow|1800mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
11005138|NCT01078909|FG004|Participant Flow|Placebo|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
11005139|NCT01078909|OG000|Outcome|300mg Fish Oil (EPA + DHA) Supplement|
11005140|NCT01078909|OG001|Outcome|600mg Fish Oil (EPA+DHA) Supplement|
11005141|NCT01078909|OG002|Outcome|900mg Fish Oil (EPA + DHA) Supplement|
11005142|NCT01078909|OG003|Outcome|1800mg Fish Oil (EPA + DHA) Supplement|
11005143|NCT01078909|OG004|Outcome|Placebo|
11005144|NCT01078909|EG000|Reported Event|300 mg/d EPA + DHA (Fish Oil) Supplement|
11005145|NCT01078909|EG001|Reported Event|600 mg/d EPA + DHA (Fish Oil) Supplement|
11005146|NCT01078909|EG002|Reported Event|900 mg/d EPA + DHA (Fish Oil) Supplement|
11005147|NCT01078909|EG003|Reported Event|1800 mg/d EPA + DHA (Fish Oil) Supplement|
11005148|NCT01078909|EG004|Reported Event|0 mg/d EPA + DHA (Placebo)|
11005149|NCT01078922|BG000|Baseline|Ofatumumab|The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
11005150|NCT01078922|FG000|Participant Flow|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
11005151|NCT01078922|OG000|Outcome|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
11007865|NCT01093521|OG001|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day"
11114790|NCT01670292|OG000|Outcome|HVLA-SM at Baseline|"Results at Baseline~Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
11005152|NCT01078922|OG000|Outcome|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.~Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
11005153|NCT01078922|EG000|Reported Event|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.~Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
11005154|NCT01078974|BG000|Baseline|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
11005155|NCT01078974|FG000|Participant Flow|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
11005156|NCT01078974|OG000|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
11005157|NCT01078974|EG000|Reported Event|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
11005158|NCT01079130|BG000|Baseline|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
11005159|NCT01079130|BG001|Baseline|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005160|NCT01079130|BG002|Baseline|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005161|NCT01079130|BG003|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005162|NCT01079130|BG004|Baseline|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005163|NCT01079130|BG005|Baseline|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005164|NCT01079130|BG006|Baseline|Total|Total of all reporting groups
11005165|NCT01079130|FG000|Participant Flow|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
11005166|NCT01079130|FG001|Participant Flow|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
10848768|NCT00291447|FG001|Participant Flow|Cohort 2|"Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11005167|NCT01079130|FG002|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005168|NCT01079130|FG003|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005169|NCT01079130|FG004|Participant Flow|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005170|NCT01079130|FG005|Participant Flow|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005171|NCT01079130|OG000|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
11005172|NCT01079130|OG001|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005173|NCT01079130|OG002|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005174|NCT01079130|OG003|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005175|NCT01079130|OG004|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005176|NCT01079130|OG005|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005177|NCT01079130|EG000|Reported Event|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
11005178|NCT01079130|EG001|Reported Event|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005179|NCT01079130|EG002|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005180|NCT01079130|EG003|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005181|NCT01079130|EG004|Reported Event|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11005182|NCT01079130|EG005|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
11114791|NCT01670292|OG001|Outcome|HVLA-SM After 2 Weeks|There is only one group/arm, this is the data for the same group of participants after two weeks.
11114792|NCT01670292|OG002|Outcome|HVLA-SM After 6 Weeks|There is only one group/arm, this is the data for the same group of participants after six weeks.
11114793|NCT01670292|OG000|Outcome|Anterior-Posterior (X)|All participants are in this group, this simply defines the mean force/moment in the X direction.
11114794|NCT01670292|OG001|Outcome|Side-to-Side (Y)|All participants are in this group, this simply defines the mean force/moment in the Y direction.
11114795|NCT01670292|OG002|Outcome|Head-to-Toe (Z)|All participants are in this group, this simply defines the mean force/moment in the Z direction.
11114796|NCT01670292|OG003|Outcome|Combined|All participants are in this group, this simply defines the mean Combined force/moment (C).
11114797|NCT01670292|OG000|Outcome|HVLA-SM at Baseline|"Result at baseline. Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
11114798|NCT01670292|EG000|Reported Event|Experimental: HVLA-SM*|"Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
11114799|NCT01670487|BG000|Baseline|Vapocoolant (Pain Ease Medium Stream)|Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin
11114800|NCT01670487|BG001|Baseline|Nature's Tears|Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin
11114801|NCT01670487|BG002|Baseline|Total|Total of all reporting groups
11114802|NCT01670487|FG000|Participant Flow|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
11114803|NCT01670487|FG001|Participant Flow|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.~Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
11114804|NCT01670487|OG000|Outcome|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
11114805|NCT01670487|OG001|Outcome|Placebo (Nature's Tears)|Application of the stream steadily for 4 to 10 seconds
10848769|NCT00291447|FG002|Participant Flow|Cohort 3|"Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11114806|NCT01670487|EG000|Reported Event|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
11114807|NCT01670487|EG001|Reported Event|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.~Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
11114808|NCT01670526|BG000|Baseline|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
11114809|NCT01670526|BG001|Baseline|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
11114810|NCT01670526|BG002|Baseline|Total|Total of all reporting groups
11114811|NCT01670526|FG000|Participant Flow|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
11114812|NCT01670526|FG001|Participant Flow|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
11114813|NCT01670526|OG000|Outcome|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
11114814|NCT01670526|OG001|Outcome|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
11114815|NCT01670526|EG000|Reported Event|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
11114816|NCT01670526|EG001|Reported Event|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
11114817|NCT01670721|BG000|Baseline|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
11114818|NCT01670721|FG000|Participant Flow|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
11114819|NCT01670721|OG000|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
11114820|NCT01670721|EG000|Reported Event|Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment (maximum exposure: Week 99).
11114821|NCT01670760|BG000|Baseline|Zero-Heat-Flux|"This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.~Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature."
11114822|NCT01670760|FG000|Participant Flow|Zero-Heat-Flux|"This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.~Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature."
11114823|NCT01670760|OG000|Outcome|Zero-Heat-Flux|"This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.~Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature."
11114824|NCT01670760|EG000|Reported Event|Zero-Heat-Flux|"This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.~Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature."
11114825|NCT01670825|BG000|Baseline|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
11114826|NCT01670825|BG001|Baseline|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
11114827|NCT01670825|BG002|Baseline|Total|Total of all reporting groups
11114828|NCT01670825|FG000|Participant Flow|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
11114829|NCT01670825|FG001|Participant Flow|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
11114830|NCT01670825|OG000|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
11114831|NCT01670825|OG001|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
11114832|NCT01670825|OG000|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve~Local anethestic injection"
11114833|NCT01670825|OG001|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve~Local anethestic injection"
11114834|NCT01670825|EG000|Reported Event|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
11114835|NCT01670825|EG001|Reported Event|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
11114836|NCT01671007|BG000|Baseline|Dabigatran Etexilate - Baseline|"Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114837|NCT01671007|BG001|Baseline|Vitamin K Antagonist (VKA) - Baseline|"Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114838|NCT01671007|BG002|Baseline|Rivaroxaban - Baseline|"Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114839|NCT01671007|BG003|Baseline|Apixaban - Baseline|"Patients who were prescribed Apixaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11348335|NCT04183231|FG000|Participant Flow|Anti-caries Varnish|"topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application~Anti-caries varnish: topical tooth varnish"
11114840|NCT01671007|BG004|Baseline|Edoxaban - Baseline|"Patients who were prescribed Edoxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114841|NCT01671007|BG005|Baseline|Acetylsalicylic Acid (ASA) - Baseline|"Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114842|NCT01671007|BG006|Baseline|Antiplts Other Than ASA - Baseline|"Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114843|NCT01671007|BG007|Baseline|No Treatment - Baseline|"Patients who were prescribed no treatment at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114844|NCT01671007|BG008|Baseline|Combinations With Oral Anticoagulants - Baseline|"Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients were not included in the safety analysis as no specific treatment can be defined.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114845|NCT01671007|BG009|Baseline|Total|Total of all reporting groups
11114846|NCT01671007|FG000|Participant Flow|Dabigatran Etexilate - Baseline|"Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114847|NCT01671007|FG001|Participant Flow|Vitamin K Antagonist (VKA) - Baseline|"Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114848|NCT01671007|FG002|Participant Flow|Rivaroxaban - Baseline|"Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114849|NCT01671007|FG003|Participant Flow|Apixaban - Baseline|"Patients who were prescribed Apixaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114850|NCT01671007|FG004|Participant Flow|Edoxaban - Baseline|"Patients who were prescribed Edoxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114851|NCT01671007|FG005|Participant Flow|Acetylsalicylic Acid (ASA) - Baseline|"Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11348336|NCT04183231|OG000|Outcome|Anti-caries Varnish|"topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application~Anti-caries varnish: topical tooth varnish"
11114852|NCT01671007|FG006|Participant Flow|Antiplts Other Than ASA - Baseline|"Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114853|NCT01671007|FG007|Participant Flow|No Treatment - Baseline|"Patients who were prescribed no treatment at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114854|NCT01671007|FG008|Participant Flow|Combinations With Oral Anticoagulants - Baseline|"Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients were not included in the safety analysis as no specific treatment can be defined.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114855|NCT01671007|OG000|Outcome|Dabigatran Etexilate - Baseline|"Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114856|NCT01671007|OG001|Outcome|Vitamin K Antagonist (VKA) - Baseline|"Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11114857|NCT01671007|EG000|Reported Event|Dabigatran Etexilate - at Least Once During the Study|"All patients received at least once dabigatran etexilate during the study were included in the group. Adverse events which happened when the patients received dabigatran etexilate were reported in this group.~Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11114858|NCT01671007|EG001|Reported Event|Vitamin K Antagonist (VKA) - at Least Once During the Study|"All patients received at least once Vitamin K Antagonist (VKA) during the study were included in the group. Adverse events which happened when the patients received Vitamin K Antagonist (VKA) were reported in this group.~Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11114859|NCT01671007|EG002|Reported Event|Rivaroxaban - at Least Once During the Study|"All patients received at least once Rivaroxaban during the study were included in the group. Adverse events which happened when the patients received Rivaroxaban were reported in this group.~Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11114860|NCT01671007|EG003|Reported Event|Apixaban - at Least Once During the Study|"All patients received at least once Apixaban during the study were included in the group. Adverse events which happened when the patients received Apixaban were reported in this group.~Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11114861|NCT01671007|EG004|Reported Event|Edoxaban - at Least Once During the Study|"All patients received at least once Edoxaban during the study were included in the group. Adverse events which happened when the patients received Edoxaban were reported in this group.~Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse event happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11114862|NCT01671007|EG005|Reported Event|Acetylsalicylic Acid (ASA) - at Least Once During the Study|"All patients received at least once Acetylsalicylic acid (ASA) during the study were included in the group. Adverse events which happened when the patients received Acetylsalicylic acid (ASA) were reported in this group.~Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
10879544|NCT00458406|FG001|Participant Flow|CPAP|"Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.~Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.~In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.~Of the N=56 assessed subjects, N=13 were enrolled into the CPAP arm."
10879545|NCT00458406|OG000|Outcome|Bi-Flex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
10879546|NCT00458406|OG001|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
11005183|NCT01079143|BG000|Baseline|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
11005184|NCT01079143|BG001|Baseline|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
11005185|NCT01079143|BG002|Baseline|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005186|NCT01079143|BG003|Baseline|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005187|NCT01079143|BG004|Baseline|Total|Total of all reporting groups
11005188|NCT01079143|FG000|Participant Flow|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
11005189|NCT01079143|FG001|Participant Flow|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
11005190|NCT01079143|FG002|Participant Flow|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005191|NCT01079143|FG003|Participant Flow|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005192|NCT01079143|OG000|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
11005193|NCT01079143|OG001|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005194|NCT01079143|OG001|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
11005195|NCT01079143|OG002|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005196|NCT01079143|OG003|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005197|NCT01079143|OG000|Outcome|Yes- Fibrosis Progression|Participants who experienced fibrosis progression based on IF/TA (univariate analysis)
11005198|NCT01079143|OG001|Outcome|No- No Fibrosis Progression|Participants who did not experience fibrosis progression based on IF/TA (univariate analysis)
11005199|NCT01079143|OG000|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
11005200|NCT01079143|OG001|Outcome|Neoral|Between transplantation adn randomization, all patients have received Neoral. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic.
11005201|NCT01079143|OG001|Outcome|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005202|NCT01079143|EG000|Reported Event|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
11005203|NCT01079143|EG001|Reported Event|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
11005204|NCT01079182|BG000|Baseline|Ankylosing Spondylitis|Participants with ankylosing spondylitis
11005205|NCT01079182|FG000|Participant Flow|Ankylosing Spondylitis|Participants with ankylosing spondylitis
11005206|NCT01079182|OG000|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
11005207|NCT01079182|EG000|Reported Event|Ankylosing Spondylitis|Participants with ankylosing spondylitis
11005208|NCT01079195|BG000|Baseline|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
11005209|NCT01079195|FG000|Participant Flow|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
11005210|NCT01079195|OG000|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
10879547|NCT00458406|OG000|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
11005211|NCT01079195|EG000|Reported Event|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
11005212|NCT01079234|BG000|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
11005213|NCT01079234|BG001|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
11005214|NCT01079234|BG002|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
11005215|NCT01079234|BG003|Baseline|Total|Total of all reporting groups
11005216|NCT01079234|FG000|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
11005217|NCT01079234|FG001|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
11005218|NCT01079234|FG002|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
11005219|NCT01079234|FG003|Participant Flow|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
11005220|NCT01079234|OG000|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
11005221|NCT01079234|OG001|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
11005222|NCT01079234|OG002|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
11005223|NCT01079234|OG000|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
11005224|NCT01079234|OG001|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
11005225|NCT01079234|EG000|Reported Event|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
11005226|NCT01079234|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
11005227|NCT01079299|BG000|Baseline|IPC Plus Standard Compression|
11005228|NCT01079299|BG001|Baseline|Standard Compression Alone|
11005229|NCT01079299|BG002|Baseline|Total|Total of all reporting groups
11005230|NCT01079299|FG000|Participant Flow|IPC Plus Standard Compression|
11005231|NCT01079299|FG001|Participant Flow|Standard Compression Alone|
11005232|NCT01079299|OG000|Outcome|IPC Plus Standard Compression|
11005233|NCT01079299|OG001|Outcome|Standard Compression Alone|
11005234|NCT01079299|EG000|Reported Event|IPC Plus Standard Compression|
11005235|NCT01079299|EG001|Reported Event|Standard Compression Alone|
11005236|NCT01079390|BG000|Baseline|High Dose Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005237|NCT01079390|BG001|Baseline|Low Dose Acupuncture|"two needles will be applied.~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005238|NCT01079390|BG002|Baseline|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005239|NCT01079390|BG003|Baseline|Total|Total of all reporting groups
11005240|NCT01079390|FG000|Participant Flow|High Dose Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005241|NCT01079390|FG001|Participant Flow|Low Dose Acupuncture|"two needles will be applied.~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005242|NCT01079390|FG002|Participant Flow|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005243|NCT01079390|OG000|Outcome|High Dose Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005244|NCT01079390|OG001|Outcome|Low Dose Acupuncture|"two needles will be applied.~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005245|NCT01079390|OG002|Outcome|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005246|NCT01079390|OG000|Outcome|Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high or low dose."
11005247|NCT01079390|OG001|Outcome|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive sham acupuncture treatment."
11005248|NCT01079390|EG000|Reported Event|High Dose Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005249|NCT01079390|EG001|Reported Event|Low Dose Acupuncture|"two needles will be applied.~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005250|NCT01079390|EG002|Reported Event|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
11005251|NCT01079663|BG000|Baseline|Chlorhexidine Chip (Periochip®)|"PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate~Chlorhexidine 2.5 mg"
11005252|NCT01079663|BG001|Baseline|Placebo Chip|Placebo chip
11005253|NCT01079663|BG002|Baseline|Total|Total of all reporting groups
11005254|NCT01079663|FG000|Participant Flow|Chlorhexidine Chip (Periochip®)|"PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate~Chlorhexidine 2.5 mg"
11005255|NCT01079663|FG001|Participant Flow|Placebo Chip|Placebo chip
11005256|NCT01079663|OG000|Outcome|Chlorhexidine Chip (Periochip®)|"PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate~Chlorhexidine 2.5 mg"
11005257|NCT01079663|OG001|Outcome|Placebo Chip|Placebo chip
11005258|NCT01079663|EG000|Reported Event|Chlorhexidine Chip (Periochip®)|"PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate~Chlorhexidine 2.5 mg"
11005259|NCT01079663|EG001|Reported Event|Placebo Chip|Placebo chip
11005260|NCT01079741|BG000|Baseline|Poly-ICLC 0.35 mg|Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
11005261|NCT01079741|BG001|Baseline|Poly-ICLC 0.70 mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
11005262|NCT01079741|BG002|Baseline|Poly-ICLC 1.4mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
11005263|NCT01079741|BG003|Baseline|NY-ESO-1 Protein and Poly-ICLC|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
11005264|NCT01079741|BG004|Baseline|NY-ESO-1 Protein, Poly-ICLC and Montanide|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
11005265|NCT01079741|BG005|Baseline|Total|Total of all reporting groups
11005266|NCT01079741|FG000|Participant Flow|Poly-ICLC 0.35mg|Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
11005267|NCT01079741|FG001|Participant Flow|Poly-ICLC 0.7mg|Cohort 2 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
11005268|NCT01079741|FG002|Participant Flow|Poly-ICLC 1.4mg|Cohort 3 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
11005269|NCT01079741|FG003|Participant Flow|NY-ESO-1 Protein and Poly-ICLC|Phase 2, Arm 1 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
11005270|NCT01079741|FG004|Participant Flow|NY-ESO-1 Protein, Poly-ICLC and Montanide|Phase 2, Arm 2 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
11005271|NCT01079741|OG000|Outcome|Poly-ICLC 0.35 mg|Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
11005272|NCT01079741|OG001|Outcome|Poly-ICLC 0.70 mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
11005273|NCT01079741|OG002|Outcome|Poly-ICLC 1.4mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
11005274|NCT01079741|OG000|Outcome|NY-ESO-1 Protein and Poly-ICLC|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
11005275|NCT01079741|OG001|Outcome|NY-ESO-1 Protein, Poly-ICLC and Montanide|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
11005276|NCT01079741|EG000|Reported Event|Poly-ICLC 0.35 mg|Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
11005277|NCT01079741|EG001|Reported Event|Poly-ICLC 0.70 mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
11005278|NCT01079741|EG002|Reported Event|Poly-ICLC 1.4mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
11005279|NCT01079741|EG003|Reported Event|Phase 2, Arm 1|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
11005280|NCT01079741|EG004|Reported Event|Phase 2, Arm 2|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
11005281|NCT01079806|BG000|Baseline|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response.
11005282|NCT01079806|BG001|Baseline|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
11005283|NCT01079806|BG002|Baseline|Total|Total of all reporting groups
11005284|NCT01079806|FG000|Participant Flow|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response.
11005285|NCT01079806|FG001|Participant Flow|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
11005286|NCT01079806|OG000|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response.
11005287|NCT01079806|OG001|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
11005288|NCT01079806|OG000|Outcome|Blinded and Open-Label (All ETV)|Randomized ETV subjects combined with PBO-randomized subjects who received open-label ETV
11005289|NCT01079806|OG000|Outcome|Blinded and Open-Label (All ETV)|All ETV group during long-term follow-up that show increased ALT (alanine aminotransferase)
11005290|NCT01079806|EG000|Reported Event|ETV (Entecavir)|Subjects received 0.015 milligram per kilogram per day (mg/kg/day) (up to a maximum dose of 0.5 mg/day) ETV as oral solution or tablets, once daily (QD).
11005291|NCT01079806|EG001|Reported Event|PLACEBO|Subjects received ETV matched placebo as oral solution or tablets, QD.
11005292|NCT01079832|BG000|Baseline|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
11005293|NCT01079832|FG000|Participant Flow|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
11005294|NCT01079832|OG000|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
11005295|NCT01079832|EG000|Reported Event|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
11005296|NCT01079936|BG000|Baseline|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005297|NCT01079936|BG001|Baseline|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005298|NCT01079936|BG002|Baseline|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005299|NCT01079936|BG003|Baseline|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005300|NCT01079936|BG004|Baseline|Total|Total of all reporting groups
11005301|NCT01079936|FG000|Participant Flow|Phase I: Lenalidomide + High-Dose Melphalan|Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005302|NCT01079936|FG001|Participant Flow|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005303|NCT01079936|FG002|Participant Flow|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005304|NCT01079936|FG003|Participant Flow|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005305|NCT01079936|FG004|Participant Flow|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005306|NCT01079936|OG000|Outcome|Lenalidomide + High-Dose Melphalan|"Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.~Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2~Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion~Stem Cell Infusion: Stem cell infusion on Day 0."
11005307|NCT01079936|OG000|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005308|NCT01079936|OG001|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005309|NCT01079936|OG002|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005310|NCT01079936|OG003|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005311|NCT01079936|EG000|Reported Event|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005312|NCT01079936|EG001|Reported Event|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005313|NCT01079936|EG002|Reported Event|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11005314|NCT01079936|EG003|Reported Event|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
11007866|NCT01093521|OG000|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
11007867|NCT01093521|EG000|Reported Event|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
11007868|NCT01093534|BG000|Baseline|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
11114863|NCT01671007|EG006|Reported Event|Antiplts Other Than ASA - at Least Once During the Study|"All patients received at least once Antiplts other than Acetylsalicylic acid (ASA) during the study were included in the group. Adverse events which happened when the patients received Antiplts other than ASA were reported in this group.~Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11114864|NCT01671059|BG000|Baseline|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
11114865|NCT01671059|FG000|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
11114866|NCT01671059|OG000|Outcome|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
11114867|NCT01671059|OG000|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
11114868|NCT01671059|EG000|Reported Event|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
11114869|NCT01671085|BG000|Baseline|1.0 mg/kg of LY3015014|LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions (Q4W) (Days 1 and 29).
11114870|NCT01671085|BG001|Baseline|Placebo|Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
11114871|NCT01671085|BG002|Baseline|Total|Total of all reporting groups
11114872|NCT01671085|FG000|Participant Flow|1.0 mg/kg of LY3015014|LY3015014: 1.0 milligram per kilogram (mg/kg) of LY3015014 subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
11114873|NCT01671085|FG001|Participant Flow|Placebo|Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
11114874|NCT01671085|OG000|Outcome|1.0 mg/kg of LY3015014|LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29).
11114875|NCT01671085|OG001|Outcome|Placebo|Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
11114876|NCT01671085|OG001|Outcome|Placebo|Placebo: 0.9% sodium chloride injection given SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
11114877|NCT01671085|EG000|Reported Event|1.0 mg/kg of LY3015014|LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29).
11114878|NCT01671085|EG001|Reported Event|Placebo|Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
11114879|NCT01671111|BG000|Baseline|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
11114880|NCT01671111|FG000|Participant Flow|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 milligram per kilogram per day (mg/kg/day) (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
10846063|NCT00272792|OG000|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
11114881|NCT01671111|OG000|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
11114882|NCT01671111|EG000|Reported Event|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
10879548|NCT00458406|OG001|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
11114883|NCT01671176|BG000|Baseline|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
11114884|NCT01671176|FG000|Participant Flow|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
11114885|NCT01671176|OG000|Outcome|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
10879549|NCT00458406|OG000|Outcome|BiFlex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
11005315|NCT01079949|BG000|Baseline|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
11005316|NCT01079949|BG001|Baseline|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
11005317|NCT01079949|BG002|Baseline|Total|Total of all reporting groups
11005318|NCT01079949|FG000|Participant Flow|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
11005319|NCT01079949|FG001|Participant Flow|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
11005320|NCT01079949|OG000|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
11005321|NCT01079949|OG001|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
11005322|NCT01079949|EG000|Reported Event|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
11005323|NCT01079949|EG001|Reported Event|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
11005324|NCT01079962|BG000|Baseline|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
11005325|NCT01079962|BG001|Baseline|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
11005326|NCT01079962|BG002|Baseline|Total|Total of all reporting groups
11005327|NCT01079962|FG000|Participant Flow|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
11005328|NCT01079962|FG001|Participant Flow|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
11114886|NCT01671176|EG000|Reported Event|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
11114887|NCT01671280|BG000|Baseline|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
11114888|NCT01671280|FG000|Participant Flow|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
11114889|NCT01671280|OG000|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
11114890|NCT01671280|EG000|Reported Event|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
11114891|NCT01671293|BG000|Baseline|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
11114892|NCT01671293|BG001|Baseline|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
11114893|NCT01671293|BG002|Baseline|Total|Total of all reporting groups
11114894|NCT01671293|FG000|Participant Flow|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
11114895|NCT01671293|FG001|Participant Flow|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
11114896|NCT01671293|OG000|Outcome|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
11114897|NCT01671293|OG001|Outcome|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
11114898|NCT01671293|EG000|Reported Event|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
11114899|NCT01671293|EG001|Reported Event|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
10846064|NCT00272792|OG001|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
11114900|NCT01671319|BG000|Baseline|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
11114901|NCT01671319|FG000|Participant Flow|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
11114902|NCT01671319|OG000|Outcome|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
11114903|NCT01671319|EG000|Reported Event|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
11114904|NCT01671332|BG000|Baseline|Docetaxel|"Docetaxel: IV over 60 minutes, 75 mg/m2~Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm."
11114905|NCT01671332|BG001|Baseline|Docetaxel Plus Suramin|"Suramin: IV over 30 minutes~Docetaxel: IV over 60 minutes. 56 mg/m2"
11114906|NCT01671332|BG002|Baseline|Total|Total of all reporting groups
11114907|NCT01671332|FG000|Participant Flow|Docetaxel|"Docetaxel: IV over 60 minutes, 75 mg/m2~Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm."
11114908|NCT01671332|FG001|Participant Flow|Docetaxel Plus Suramin|"Suramin: IV over 30 minutes~Docetaxel: IV over 60 minutes. 56 mg/m2"
11114909|NCT01671332|OG000|Outcome|Docetaxel|"Docetaxel: IV over 60 minutes, 75 mg/m2~Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm."
10846065|NCT00272792|EG000|Reported Event|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
11114910|NCT01671332|OG001|Outcome|Docetaxel Plus Suramin|"Suramin: IV over 30 minutes~Docetaxel: IV over 60 minutes. 56 mg/m2"
11114911|NCT01671332|EG000|Reported Event|Docetaxel|"Docetaxel: IV over 60 minutes, 75 mg/m2~Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm."
11114912|NCT01671332|EG001|Reported Event|Docetaxel Plus Suramin|"Suramin: IV over 30 minutes~Docetaxel: IV over 60 minutes. 56 mg/m2"
11114913|NCT01671345|BG000|Baseline|Intervention|"Patients randomized to the intervention view the intervention video.~Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence."
11114914|NCT01671345|BG001|Baseline|Control|"Patients randomized to control view an informative video about diet and nutrition of similar length.~Control: Attention control."
11114915|NCT01671345|BG002|Baseline|Total|Total of all reporting groups
11114916|NCT01671345|FG000|Participant Flow|Intervention|"Patients randomized to the intervention view the intervention video.~Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence."
11114917|NCT01671345|FG001|Participant Flow|Control|"Patients randomized to control view an informative video about diet and nutrition of similar length.~Control: Attention control."
11114918|NCT01671345|OG000|Outcome|Intervention|"Patients randomized to the intervention view the intervention video.~Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence."
11114919|NCT01671345|OG001|Outcome|Control|"Patients randomized to control view an informative video about diet and nutrition of similar length.~Control: Attention control"
11114920|NCT01671345|OG000|Outcome|Intervention|"Patients randomized to the intervention view the intervention video~Intervention Video: A video intervention delivered prior to patients' visit 2 with primary care physician designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence"
11114921|NCT01671345|OG000|Outcome|Intervention|"Patients randomized to the intervention view the intervention video~Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence."
11114922|NCT01671345|OG001|Outcome|Control|"Patients randomized to control view an informative video about diet and nutrition of similar length~Control: Attention control"
11114923|NCT01671345|EG000|Reported Event|Intervention|"Patients randomized to the intervention view the intervention video.~Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence."
11114924|NCT01671345|EG001|Reported Event|Control|"Patients randomized to control will view an informative video about diet and nutrition of similar length.~Control: Attention control."
11114925|NCT01671423|BG000|Baseline|Prednisone|"In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.~Prednisone: See Prednisone arm description"
11114926|NCT01671423|BG001|Baseline|Placebo|"In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.~Placebo: See Placebo arm description"
11114927|NCT01671423|BG002|Baseline|Total|Total of all reporting groups
11114928|NCT01671423|FG000|Participant Flow|Prednisone|"In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.~Prednisone: See Prednisone arm description"
11114929|NCT01671423|FG001|Participant Flow|Placebo|"In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.~Placebo: See Placebo arm description"
11114930|NCT01671423|OG000|Outcome|Prednisone|"In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.~Prednisone: See Prednisone arm description"
11114931|NCT01671423|OG001|Outcome|Placebo|"In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.~Placebo: See Placebo arm description"
11114932|NCT01671423|EG000|Reported Event|Prednisone|"In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.~Prednisone: See Prednisone arm description"
11114933|NCT01671423|EG001|Reported Event|Placebo|"In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.~Placebo: See Placebo arm description"
11114934|NCT01671488|BG000|Baseline|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
11114935|NCT01671488|FG000|Participant Flow|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
11114936|NCT01671488|OG000|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
11114937|NCT01671488|EG000|Reported Event|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
11114938|NCT01671605|BG000|Baseline|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
11114939|NCT01671605|BG001|Baseline|Controls|Controls with normal kidney function (Control)
11114940|NCT01671605|BG002|Baseline|Total|Total of all reporting groups
11114941|NCT01671605|FG000|Participant Flow|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
11114942|NCT01671605|FG001|Participant Flow|Controls|Controls with normal kidney function (Control)
11114943|NCT01671605|OG000|Outcome|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
11114944|NCT01671605|OG001|Outcome|Controls|Controls with normal kidney function (Control)
11114945|NCT01671605|EG000|Reported Event|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
11114946|NCT01671605|EG001|Reported Event|Controls|Controls with normal kidney function (Control)
11114947|NCT01671748|BG000|Baseline|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
11114948|NCT01671748|BG001|Baseline|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
11114949|NCT01671748|BG002|Baseline|Total|Total of all reporting groups
11114950|NCT01671748|FG000|Participant Flow|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
10879550|NCT00458406|OG000|Outcome|BiFlex|Change in Obstructive Sleep Apnea (OSA) 18 score in participants on BiFlex
11114951|NCT01671748|FG001|Participant Flow|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
11114952|NCT01671748|OG000|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
11114953|NCT01671748|OG001|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
11114954|NCT01671748|EG000|Reported Event|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
11114955|NCT01671748|EG001|Reported Event|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
11114956|NCT01671839|BG000|Baseline|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
11114957|NCT01671839|FG000|Participant Flow|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
11114958|NCT01671839|OG000|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
11114959|NCT01671839|OG000|Outcome|Subcutaneous Tissue Release - 3 Years|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
11114960|NCT01671839|OG001|Outcome|Subcutaneous Tissue Release - 5 Years|
11114961|NCT01671839|EG000|Reported Event|Subcutaneous Tissue Release - 3 Years|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
11114962|NCT01671839|EG001|Reported Event|Subcutaneous Tissue Release - Years 4-5|
11114963|NCT01672294|BG000|Baseline|Caregiver Outlook - Caregiver|Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
11114964|NCT01672294|BG001|Baseline|Caregiver Outlook - Patient|Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
11114965|NCT01672294|BG002|Baseline|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
11114966|NCT01672294|BG003|Baseline|Relaxation Meditation - Patient|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD..
11114967|NCT01672294|BG004|Baseline|Total|Total of all reporting groups
11114968|NCT01672294|FG000|Participant Flow|Caregiver Outlook - Caregiver|"Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Topics included life review, issues of forgiveness and heritage and legacy."
11114969|NCT01672294|FG001|Participant Flow|Caregiver Outlook - Patient|"Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Topics included life review, issues of forgiveness and heritage and legacy."
11114970|NCT01672294|FG002|Participant Flow|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
11114971|NCT01672294|FG003|Participant Flow|Relaxation Meditation - Patient|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
11114972|NCT01672294|OG000|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
11114973|NCT01672294|OG001|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
11114974|NCT01672294|OG000|Outcome|Caregiver Outlook - Patient|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
11114975|NCT01672294|OG001|Outcome|Relaxation Meditation - Patient|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
11114976|NCT01672294|EG000|Reported Event|Caregiver Outlook - Caregiver|Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy.
11114977|NCT01672294|EG001|Reported Event|Caregiver Outlook - Patient|Patients of the caregivers in the Outlook Intervention arm.
11114978|NCT01672294|EG002|Reported Event|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
11114979|NCT01672294|EG003|Reported Event|Relaxation Meditation - Patient|Patients of the caregivers in the Attention Control arm.
11114980|NCT01672658|BG000|Baseline|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
11114981|NCT01672658|BG001|Baseline|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
11114982|NCT01672658|BG002|Baseline|Total|Total of all reporting groups
10878629|NCT00453388|OG000|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878630|NCT00453388|OG001|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878631|NCT00453388|OG002|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878632|NCT00453388|OG003|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878633|NCT00453388|EG000|Reported Event|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878634|NCT00453388|EG001|Reported Event|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878635|NCT00453388|EG002|Reported Event|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878636|NCT00453388|EG003|Reported Event|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
10878637|NCT00453479|BG000|Baseline|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
10879551|NCT00458406|OG001|Outcome|CPAP|Change in Obstructive Sleep Apnea (OSA) 18 score in participants on CPAP
10879552|NCT00458406|OG000|Outcome|BiFlex|Change in QOL from baseline to 3 months
10879553|NCT00458406|OG001|Outcome|CPAP|Change in QOL from baseline to 3 months
11114983|NCT01672658|FG000|Participant Flow|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
11114984|NCT01672658|FG001|Participant Flow|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
11114985|NCT01672658|OG000|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
11114986|NCT01672658|OG001|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
11114987|NCT01672658|EG000|Reported Event|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
11114988|NCT01672658|EG001|Reported Event|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
11114989|NCT01672710|BG000|Baseline|Niacin, Exercise, Sauna,|plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
11114990|NCT01672710|BG001|Baseline|no Intervention|treatment as usual for 4 weeks
11114991|NCT01672710|BG002|Baseline|Total|Total of all reporting groups
11114992|NCT01672710|FG000|Participant Flow|Niacin, Exercise, Sauna,|plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
11114993|NCT01672710|FG001|Participant Flow|no Intervention|waitlisted group receives treatment as usual for 4 weeks
11114994|NCT01672710|OG000|Outcome|Niacin, Exercise, Sauna,|plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
11114995|NCT01672710|OG001|Outcome|no Intervention|
11114996|NCT01672710|EG000|Reported Event|Niacin, Exercise, Sauna|the immediate intervention group (n=22) completed the step in 4 weeks,
11114997|NCT01672710|EG001|Reported Event|no Intervention Waitlist|received only usual care, followed by (n=10) crossed over to receive the intervention for a 4 week period
11114998|NCT01672723|BG000|Baseline|Naltrexone First and Placebo First|Includes groups randomized to receive naltrexone first and placebo first.
11114999|NCT01672723|FG000|Participant Flow|Naltrexone First, Then Placebo|Participants took 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) followed by a 10-day washout period and finally, 4 matched placebo pills for another 4 days.
11115000|NCT01672723|FG001|Participant Flow|Placebo First, Then Naltrexone|Participants took 4 placebo pills over 4 days (one pill a day), followed by a 10-day washout period, followed by 4 naltrexone pills for 4 days (25 mg on days 1 and 2, 50mg on days 3 and 4)
11115001|NCT01672723|OG000|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
11115002|NCT01672723|OG001|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
11126721|NCT01734993|EG000|Reported Event|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
11115003|NCT01672723|EG000|Reported Event|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
11115004|NCT01672723|EG001|Reported Event|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
11115005|NCT01672736|BG000|Baseline|ASP7487, Velcade, Dexamethasone|"ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg~ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration"
11115006|NCT01672736|FG000|Participant Flow|ASP7487, Velcade, Dexamethasone|"ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg~ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration"
11115007|NCT01672736|OG000|Outcome|ASP7487, Velcade, Dexamethasone|"ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg~ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration"
11115008|NCT01672736|EG000|Reported Event|ASP7487, Velcade, Dexamethasone|"ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg~ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration"
11115009|NCT01672788|BG000|Baseline|Overall Study|Total number of patients randomised and treated in the study. This was an open-label, randomized, 4-way crossover trial. 36 patients were randomised to one of 4 treatment sequences and treated. Each treatment period consisted of a single dose of medication followed by 72hours of pharmacokinetic sampling, with a washout of at least 7 days between treatment periods.
11115010|NCT01672788|FG000|Participant Flow|T1 / R1 / T2 / R2|"Patients received the 4 treatments in the following order:~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)"
11115011|NCT01672788|FG001|Participant Flow|R1 / T1 / R2 / T2|"Patients received the 4 treatments in the following order:~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)"
11115012|NCT01672788|FG002|Participant Flow|T2 / R2 / T1 / R1|"Patients received the 4 treatments in the following order:~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)"
11115013|NCT01672788|FG003|Participant Flow|R2 / T2 / R1 / T1|"Patients received the 4 treatments in the following order:~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)"
11115014|NCT01672788|OG000|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
11115015|NCT01672788|OG001|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
11115016|NCT01672788|OG002|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
11115017|NCT01672788|OG003|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
11115018|NCT01672788|EG000|Reported Event|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
11115019|NCT01672788|EG001|Reported Event|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
11115020|NCT01672788|EG002|Reported Event|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
11115021|NCT01672788|EG003|Reported Event|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
11115022|NCT01672801|BG000|Baseline|Placebo|"All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes~Placebo: oral administration"
11115023|NCT01672801|BG001|Baseline|Nimodipine|"All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes~Nimodipine: oral administration"
11115024|NCT01672801|BG002|Baseline|Total|Total of all reporting groups
11115025|NCT01672801|FG000|Participant Flow|Placebo|"All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes~Placebo: oral administration"
11115026|NCT01672801|FG001|Participant Flow|Nimodipine|"All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes~Nimodipine: oral administration"
11115027|NCT01672801|OG000|Outcome|Placebo|"All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes~Placebo: oral administration"
11115028|NCT01672801|OG001|Outcome|Nimodipine|"All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes~Nimodipine: oral administration"
11115029|NCT01672801|EG000|Reported Event|Placebo|"All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes~Placebo: oral administration"
11115030|NCT01672801|EG001|Reported Event|Nimodipine|"All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes~Nimodipine: oral administration"
11115031|NCT01672827|BG000|Baseline|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images.
11115032|NCT01672827|FG000|Participant Flow|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to show the PET Image Interpretations among investigators. The study did not enroll the blinded image Readers.
11115033|NCT01672827|OG000|Outcome|Sensitivity %|Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.
10879554|NCT00458406|EG000|Reported Event|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
11115034|NCT01672827|OG000|Outcome|Inter-Reader Agreement|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images.
11115035|NCT01672827|OG000|Outcome|Specificity %|Specificity of the blinded visual PET Image Interpretations without Anatomic Images.
11115036|NCT01672827|EG000|Reported Event|[18F]Flutemetamol|No adverse event data collected because no subjects were dosed in this study , therefore no subjects were at risk.
11115037|NCT01672853|BG000|Baseline|SIM 75 mg|SIM 75 mg subcutaneous injections weekly for 96 weeks
11115038|NCT01672853|BG001|Baseline|SIM 125 mg|SIM 125 mg subcutaneous injections weekly for 96 weeks
11115039|NCT01672853|BG002|Baseline|Placebo|Placebo subcutaneous injections weekly for 96 weeks
11115040|NCT01672853|BG003|Baseline|Total|Total of all reporting groups
11115041|NCT01672853|FG000|Participant Flow|SIM 75 mg|Simtuzumab (SIM) 75 mg subcutaneous injections weekly for 96 weeks
11115042|NCT01672853|FG001|Participant Flow|SIM 125 mg|SIM 125 mg subcutaneous injections weekly for 96 weeks
11115043|NCT01672853|FG002|Participant Flow|Placebo|Placebo subcutaneous injections weekly for 96 weeks
11115044|NCT01672853|OG000|Outcome|SIM 75 mg|SIM 75 mg subcutaneous injections weekly for 96 weeks
11115045|NCT01672853|OG001|Outcome|SIM 125 mg|SIM 125 mg subcutaneous injections weekly for 96 weeks
11115046|NCT01672853|OG002|Outcome|Placebo|Placebo subcutaneous injections weekly for 96 weeks
11115047|NCT01672853|EG000|Reported Event|SIM 75 mg|SIM 75 mg subcutaneous injections weekly for 96 weeks
11115048|NCT01672853|EG001|Reported Event|SIM 125 mg|SIM 125 mg subcutaneous injections weekly for 96 weeks
11115049|NCT01672853|EG002|Reported Event|Placebo|Placebo subcutaneous injections weekly for 96 weeks
11115050|NCT01672866|BG000|Baseline|SIM 75 mg|Blinded Phase: Participants received SIM 75 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115051|NCT01672866|BG001|Baseline|SIM 125 mg|Blinded Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115052|NCT01672866|BG002|Baseline|Placebo|Blinded Phase: Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115053|NCT01672866|BG003|Baseline|Total|Total of all reporting groups
11115054|NCT01672866|FG000|Participant Flow|SIM 75 mg|Blinded Phase: Participants received simtuzumab (SIM) 75 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115055|NCT01672866|FG001|Participant Flow|SIM 125 mg|Blinded Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115056|NCT01672866|FG002|Participant Flow|Placebo|Blinded Phase: Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115057|NCT01672866|OG000|Outcome|SIM 75 mg|Blinded Phase: Participants received SIM 75 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115058|NCT01672866|OG001|Outcome|SIM 125 mg|Blinded Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115059|NCT01672866|OG002|Outcome|Placebo|Blinded Phase: Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.
11115060|NCT01672866|OG001|Outcome|SIM 125 mg|Blinded Phase: Participants received SIM 125 mg subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg subcutaneous injection weekly for up to an additional 240 weeks.
11115061|NCT01672866|EG000|Reported Event|Blinded Phase: SIM 75 mg|Adverse events reported in this group occurred during the Blinded Phase. Participants received SIM 75 mg via subcutaneous injection weekly for up to 240 weeks.
11115062|NCT01672866|EG001|Reported Event|Blinded Phase: SIM 125 mg|Adverse events reported in this group occurred during the Blinded Phase. Participants received SIM 125 mg via subcutaneous injection weekly for up to 240 weeks.
11115063|NCT01672866|EG002|Reported Event|Blinded Phase: Placebo|Adverse events reported in this group occurred during the Blinded Phase. Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks.
11115064|NCT01672866|EG003|Reported Event|Open-Label Phase: SIM 125 mg|All participants who completed the Blinded Phase through the Week 240 visit, or were ongoing at the time the study stopped, or who had progressed cirrhosis of the liver, were offered the opportunity to receive open-label SIM for up to 240 additional weeks. Additionally, participants who developed confirmed progression to cirrhosis prior to completing the Blinded Phase were eligible to roll over into the open-label phase. Adverse events reported in this group occurred during the Open-Label Phase. All participants received fixed-dose open-label SIM 125 mg via subcutaneous injection every week for up to 240 weeks.
11115065|NCT01672879|BG000|Baseline|SIM 200 mg|"Blinded Phase: Participants received SIM 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115066|NCT01672879|BG001|Baseline|SIM 700 mg|"Blinded Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115067|NCT01672879|BG002|Baseline|Placebo|"Blinded Phase: Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115068|NCT01672879|BG003|Baseline|Total|Total of all reporting groups
10848770|NCT00291447|FG003|Participant Flow|Cohort 4|"Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11115069|NCT01672879|FG000|Participant Flow|SIM 200 mg|"Blinded Phase: Participants received simtuzumab (SIM) 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115070|NCT01672879|FG001|Participant Flow|SIM 700 mg|"Blinded Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115071|NCT01672879|FG002|Participant Flow|Placebo|"Blinded Phase: Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115072|NCT01672879|OG000|Outcome|SIM 200 mg|"Blinded Phase: Participants received SIM 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115073|NCT01672879|OG001|Outcome|SIM 700 mg|"Blinded Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115074|NCT01672879|OG002|Outcome|Placebo|"Blinded Phase: Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.~Open-Label Phase: Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks."
11115075|NCT01672879|EG000|Reported Event|Blinded Phase: SIM 200 mg|Adverse events recorded in this group occurred during the Blinded Phase. Participants received SIM 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.
11115076|NCT01672879|EG001|Reported Event|Blinded Phase: SIM 700 mg|Adverse events recorded in this group occurred during the Blinded Phase. Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.
11115077|NCT01672879|EG002|Reported Event|Blinded Phase: Placebo|Adverse events recorded in this group occurred during the Blinded Phase. Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.
11115078|NCT01672879|EG003|Reported Event|Open-Label Phase: SIM 700 mg|All participants who completed the randomized phase through the Week 240 visit, or who had an adjudicated clinical event prior to completing the randomized phase, were offered the opportunity to receive open-label SIM for up to 240 additional weeks. Adverse events recorded in this group occurred during the Open-Label Phase. All participants received fixed-dose open-label SIM 700 mg intravenous infusions every 2 weeks for up to 240 weeks.
11115079|NCT01672957|BG000|Baseline|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
11115080|NCT01672957|FG000|Participant Flow|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.
11115081|NCT01672957|OG000|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
11115082|NCT01672957|EG000|Reported Event|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
11115083|NCT01672970|BG000|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
11115084|NCT01672970|FG000|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria, in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
11115085|NCT01672970|OG000|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
11115086|NCT01672970|EG000|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
11115087|NCT01672983|BG000|Baseline|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115088|NCT01672983|BG001|Baseline|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115089|NCT01672983|BG002|Baseline|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
11115090|NCT01672983|BG003|Baseline|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
11115091|NCT01672983|BG004|Baseline|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115092|NCT01672983|BG005|Baseline|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115093|NCT01672983|BG006|Baseline|Total|Total of all reporting groups
10846066|NCT00272792|EG001|Reported Event|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
11115094|NCT01672983|FG000|Participant Flow|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115095|NCT01672983|FG001|Participant Flow|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115096|NCT01672983|FG002|Participant Flow|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
11115097|NCT01672983|FG003|Participant Flow|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
11115098|NCT01672983|FG004|Participant Flow|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115099|NCT01672983|FG005|Participant Flow|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
10879555|NCT00458406|EG001|Reported Event|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
11115100|NCT01672983|OG000|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11005329|NCT01079962|OG000|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
11005330|NCT01079962|OG001|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
11005331|NCT01079962|EG000|Reported Event|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
11005332|NCT01079962|EG001|Reported Event|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
11005333|NCT01079988|BG000|Baseline|Cyclosporin|Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
11005334|NCT01079988|BG001|Baseline|Retinoids|Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
11005335|NCT01079988|BG002|Baseline|Systemic Corticosteroids|Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
11005336|NCT01079988|BG003|Baseline|Methotrexate|Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
11005337|NCT01079988|BG004|Baseline|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
11005338|NCT01079988|BG005|Baseline|Total|Total of all reporting groups
11005339|NCT01079988|FG000|Participant Flow|Cyclosporin|Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
11005340|NCT01079988|FG001|Participant Flow|Retinoids|Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
11005341|NCT01079988|FG002|Participant Flow|Systemic Corticosteroids|Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
11005342|NCT01079988|FG003|Participant Flow|Methotrexate|Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
11005343|NCT01079988|FG004|Participant Flow|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
11005344|NCT01079988|OG000|Outcome|Cyclosporin|Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
11005345|NCT01079988|OG001|Outcome|Retinoids|Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
11005346|NCT01079988|OG002|Outcome|Systemic Corticosteroids|Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
11005347|NCT01079988|OG003|Outcome|Methotrexate|Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
11005348|NCT01079988|OG004|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
11005349|NCT01079988|EG000|Reported Event|Cyclosporin|Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
11005350|NCT01079988|EG001|Reported Event|Retinoids|Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
11005351|NCT01079988|EG002|Reported Event|Systemic Corticosteroids|Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
11005352|NCT01079988|EG003|Reported Event|Methotrexate|Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
11005353|NCT01079988|EG004|Reported Event|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
11005354|NCT01080118|BG000|Baseline|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
11005355|NCT01080118|BG001|Baseline|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
11005356|NCT01080118|BG002|Baseline|Total|Total of all reporting groups
11005357|NCT01080118|FG000|Participant Flow|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
11005358|NCT01080118|FG001|Participant Flow|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
11005359|NCT01080118|FG002|Participant Flow|Rigid Laryngoscope Patients|Patients who were intubated using the rigid laryngoscope by the medical student of intern.
11115101|NCT01672983|OG001|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115102|NCT01672983|OG002|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
11115103|NCT01672983|OG003|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
11115104|NCT01672983|OG004|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115105|NCT01672983|OG005|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115106|NCT01672983|OG000|Outcome|Arm 1 + Arm 5|Arm 1: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 5: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115107|NCT01672983|OG001|Outcome|Arm 2 + Arm 6|Arm 2: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 6: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115108|NCT01672983|OG000|Outcome|Arm 1|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
11115109|NCT01672983|OG001|Outcome|Arm 2|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
11115110|NCT01672983|OG002|Outcome|Arm 3|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
11115111|NCT01672983|OG003|Outcome|Arm 4|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
11115112|NCT01672983|OG004|Outcome|Arm 5|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
11115113|NCT01672983|OG005|Outcome|Arm 6|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
11115114|NCT01672983|EG000|Reported Event|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115115|NCT01672983|EG001|Reported Event|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115116|NCT01672983|EG002|Reported Event|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
11115117|NCT01672983|EG003|Reported Event|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
11115118|NCT01672983|EG004|Reported Event|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115119|NCT01672983|EG005|Reported Event|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
11115120|NCT01672996|BG000|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
11115121|NCT01672996|BG001|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
11115122|NCT01672996|BG002|Baseline|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
11115123|NCT01672996|BG003|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
11115124|NCT01672996|BG004|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
11115125|NCT01672996|BG005|Baseline|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
11115126|NCT01672996|BG006|Baseline|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
11115127|NCT01672996|BG007|Baseline|Total|Total of all reporting groups
11115128|NCT01672996|FG000|Participant Flow|Arm 1 - Ioforminol 160mgI/mL|"Single administration of Ioforminol 160mgI/mL given to the subject.~Ioforminol 160 mgI/mL: Given as s single administration to the subject"
11115129|NCT01672996|FG001|Participant Flow|Arm 2 - Ioforminol 200mgI/mL|"Given as a single administration to the subject~Ioforminol 200 mgI/mL: Given as a single administration to the subject"
11115130|NCT01672996|FG002|Participant Flow|Arm 3 - Iopamidol 300mgI/mL|"Given as a single administration to the subject~Iopamidol 300 mgI/mL: Given as a single administration to the subject"
11115131|NCT01672996|OG000|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
11115132|NCT01672996|OG001|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
11115133|NCT01672996|OG002|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
11115134|NCT01672996|OG003|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
11115135|NCT01672996|OG004|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
11115136|NCT01672996|OG005|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
11115137|NCT01672996|OG006|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
11115138|NCT01672996|EG000|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
11115139|NCT01672996|EG001|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
11115140|NCT01672996|EG002|Reported Event|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
11115141|NCT01672996|EG003|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
11115142|NCT01672996|EG004|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
11115143|NCT01672996|EG005|Reported Event|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
11115144|NCT01672996|EG006|Reported Event|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
11115145|NCT01673009|BG000|Baseline|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
11115146|NCT01673009|FG000|Participant Flow|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
11115147|NCT01673009|OG000|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
11115148|NCT01673009|EG000|Reported Event|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
11115149|NCT01673022|BG000|Baseline|IC Green Arm|"One arm only: Receives IC Green for testing of study objective~IC Green: IC Green"
11115150|NCT01673022|FG000|Participant Flow|IC-GREEN® (Indocyanine Green) Arm|"One arm only: Receives IC-GREEN® (Indocyanine green) for testing of study objective~IC-GREEN®: Indocyanine green"
11115151|NCT01673022|OG000|Outcome|IC Green (Indocyanine Green) Arm|"One arm only: Receives IC Green (indocyanine green) )for testing of study objective~IC Green: IC Green (indocyanine green)"
11115152|NCT01673022|EG000|Reported Event|IC Green Arm|"One arm only: Receives IC Green for testing of study objective~IC Green: IC Green"
11115153|NCT01673113|BG000|Baseline|Treatment|Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device
11115154|NCT01673113|BG001|Baseline|Control|The untreated flank of each subject served as the internal control.
11115155|NCT01673113|BG002|Baseline|Total|Total of all reporting groups
11115156|NCT01673113|FG000|Participant Flow|Treatment|Subjects were randomized to have either left or right flank treated with cryolipolysis.
11115157|NCT01673113|FG001|Participant Flow|Control|The untreated flank of each subject served as internal control.
11115158|NCT01673113|OG000|Outcome|Treatment|Cryolipolysis treated flanks had vibration sensory testing done within 48-72 hours after treatment.
11115159|NCT01673113|OG001|Outcome|Control|Untreated flanks of each subject had vibration sensory testing done within 48-72 hours after treatment.
11115160|NCT01673113|OG000|Outcome|Treatment|Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device
11115161|NCT01673113|OG001|Outcome|Control|The untreated flank of each subject served as the internal control.
11115162|NCT01673113|EG000|Reported Event|Cryolipolysis|"Zeltiq CoolSculpting device: This is an FDA approved cooling device used for non-invasive and selective reduction of fat around the flanks, an area commonly referred to as the love handles."
11115163|NCT01673126|BG000|Baseline|Anodal tDCS First|Patients received anodal tDCS during 20 minutes. Then, washout of 2days. Then sham tDCS.
11115164|NCT01673126|BG001|Baseline|Sham tDCS First|Patients received sham tDCS during 20 minutes. Then, washout of 2days. Then andoal tDCS.
11115165|NCT01673126|BG002|Baseline|Total|Total of all reporting groups
11115166|NCT01673126|FG000|Participant Flow|Anodal tDCS|Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS.
11115167|NCT01673126|FG001|Participant Flow|Sham tDCS|Sham tDCS during first, then 2 days of washout, then anodal tDCS.
11115168|NCT01673126|OG000|Outcome|Anodal tDCS First|"Patients received anodal tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).~Then, a washout period (2days). Then sham tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
11115169|NCT01673126|OG001|Outcome|Sham tDCS First|"Patients received sham tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).~Then, a washout period (2days). Then anodal tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
11115170|NCT01673126|EG000|Reported Event|Anodal tDCS|"Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)~Anodal tDCS: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)"
11115171|NCT01673126|EG001|Reported Event|Sham tDCS|"Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.~sham tDCS: Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation."
11115172|NCT01673178|BG000|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
11115173|NCT01673178|BG001|Baseline|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
11115174|NCT01673178|BG002|Baseline|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
10846067|NCT00272844|BG000|Baseline|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
11115175|NCT01673178|BG003|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115176|NCT01673178|BG004|Baseline|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115177|NCT01673178|BG005|Baseline|Total|Total of all reporting groups
11115178|NCT01673178|FG000|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
11115179|NCT01673178|FG001|Participant Flow|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
11115180|NCT01673178|FG002|Participant Flow|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115181|NCT01673178|FG003|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115182|NCT01673178|FG004|Participant Flow|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115183|NCT01673178|OG000|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
11115184|NCT01673178|OG001|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
11115185|NCT01673178|OG002|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115186|NCT01673178|OG003|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115187|NCT01673178|OG004|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115188|NCT01673178|OG000|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
11115189|NCT01673178|OG001|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115190|NCT01673178|OG002|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115191|NCT01673178|OG003|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115192|NCT01673178|EG000|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
11115193|NCT01673178|EG001|Reported Event|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
11115194|NCT01673178|EG002|Reported Event|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115195|NCT01673178|EG003|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115196|NCT01673178|EG004|Reported Event|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
11115197|NCT01673191|BG000|Baseline|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
11115198|NCT01673191|BG001|Baseline|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
11115199|NCT01673191|BG002|Baseline|Total|Total of all reporting groups
11115200|NCT01673191|FG000|Participant Flow|OZURDEX Intraocular Implant|"OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg~Dexamethasone intravitreal implant"
11115201|NCT01673191|FG001|Participant Flow|Steroid Plus NSAID Eye Drop Combination Therapy|"NSAID eye drop: Acular LS Steriod eye drop: Pred Forte~Steroid plus NSAID eye drop combination therapy"
11115202|NCT01673191|OG000|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
11115203|NCT01673191|OG001|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
11115204|NCT01673191|EG000|Reported Event|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
11126722|NCT01735175|BG000|Baseline|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11115205|NCT01673191|EG001|Reported Event|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
11115206|NCT01673256|BG000|Baseline|SJM Confirm ICM Observational Group|SJM Confirm ICM
11115207|NCT01673256|FG000|Participant Flow|SJM Confirm ICM Observational Group|SJM Confirm ICM
11115208|NCT01673256|OG000|Outcome|SJM Confirm ICM Observational Group|SJM Confirm ICM
11115209|NCT01673256|EG000|Reported Event|SJM Confirm ICM Observational Group|SJM Confirm ICM
11115210|NCT01673282|BG000|Baseline|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
11115211|NCT01673282|BG001|Baseline|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
11115212|NCT01673282|BG002|Baseline|Total Title|
11115213|NCT01673282|FG000|Participant Flow|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
11115214|NCT01673282|FG001|Participant Flow|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
11115215|NCT01673282|OG000|Outcome|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
11115216|NCT01673282|OG001|Outcome|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
11115217|NCT01673282|EG000|Reported Event|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
11115218|NCT01673282|EG001|Reported Event|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
11115219|NCT01673347|BG000|Baseline|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
11115220|NCT01673347|FG000|Participant Flow|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
11115221|NCT01673347|OG000|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
11115222|NCT01673347|EG000|Reported Event|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
11115223|NCT01673373|BG000|Baseline|iCAST™ RX Stent System|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
11115224|NCT01673373|FG000|Participant Flow|iCAST™ RX Stent System|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
11115225|NCT01673373|OG000|Outcome|iCAST™ RX Stent System|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
11115226|NCT01673373|EG000|Reported Event|iCAST™ RX Stent System|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
11115227|NCT01673386|BG000|Baseline|Overall Study|Subjects randomized to Arm 1, received 1.5 mg oral tivozanib daily on a 3 week on/1 week off schedule for 12 weeks (3 cycles) followed by 50 mg oral sunitinib daily on a 4 week on/2 week off schedule for 12 weeks (2 cycles). Subjects randomized to Arm 2, received 50 mg oral sunitinib daily on a 4 week on/2 weeks off schedule for 12 weeks followed by 1.5 mg oral tivozanib daily on a 3 week on/1 week off schedule.
11115228|NCT01673386|FG000|Participant Flow|Tivozanib First, Then Sunitinib|Subject randomized to this arm received 1.5 mg oral tivozanib hydrochloride (drug 1) daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib (drug 2) daily on a 4 weeks on/2 weeks off schedule for 12 weeks.
11115229|NCT01673386|FG001|Participant Flow|Sunitinib First, Then Tivosanib|Subject randomized to this arm received 50 mg oral sunitinib (drug 1) daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride (drug 2) daily on a 3 weeks on/1 week off schedule for 12 weeks.
11115230|NCT01673386|OG000|Outcome|Tivozanib|Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
11115231|NCT01673386|OG001|Outcome|Sunitinib|Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
11115232|NCT01673386|EG000|Reported Event|Tivozanib|Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
11115233|NCT01673386|EG001|Reported Event|Sunitinib|Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
11115234|NCT01673490|BG000|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
11115235|NCT01673490|FG000|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
11348337|NCT04183231|EG000|Reported Event|Anti-caries Varnish|"topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application~Anti-caries varnish: topical tooth varnish"
11005360|NCT01080118|FG003|Participant Flow|Video Laryngoscope Patients|Patients who were intubated using the video laryngoscope by interns or medical student.
11005361|NCT01080118|OG000|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
11005362|NCT01080118|OG001|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
11005363|NCT01080118|EG000|Reported Event|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
11005364|NCT01080118|EG001|Reported Event|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
11005365|NCT01080131|BG000|Baseline|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
11005366|NCT01080131|BG001|Baseline|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
11005367|NCT01080131|BG002|Baseline|Total|Total of all reporting groups
11005368|NCT01080131|FG000|Participant Flow|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
11005369|NCT01080131|FG001|Participant Flow|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
11005370|NCT01080131|OG000|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
11005371|NCT01080131|OG001|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
11005372|NCT01080131|OG000|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
11005373|NCT01080131|OG000|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
11005374|NCT01080131|OG001|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
11005375|NCT01080131|OG000|Outcome|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
11007869|NCT01093534|BG001|Baseline|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
11007870|NCT01093534|BG002|Baseline|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
11005376|NCT01080131|OG001|Outcome|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
11005377|NCT01080131|OG002|Outcome|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
11005378|NCT01080131|OG003|Outcome|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.~Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
11005379|NCT01080131|OG004|Outcome|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
11005380|NCT01080131|OG005|Outcome|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
11005381|NCT01080131|OG000|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
11005382|NCT01080131|OG001|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
11005383|NCT01080131|OG000|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
11005384|NCT01080131|OG001|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
11005385|NCT01080131|OG000|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the Ccre study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
11005386|NCT01080131|EG000|Reported Event|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
11005387|NCT01080131|EG001|Reported Event|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
11005388|NCT01080131|EG002|Reported Event|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
11005389|NCT01080131|EG003|Reported Event|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.~Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
11005390|NCT01080131|EG004|Reported Event|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
11007871|NCT01093534|BG003|Baseline|Total|Total of all reporting groups
11007872|NCT01093534|FG000|Participant Flow|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
11005391|NCT01080131|EG005|Reported Event|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
11005392|NCT01080209|BG000|Baseline|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
11005393|NCT01080209|BG001|Baseline|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
11005394|NCT01080209|BG002|Baseline|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
11005395|NCT01080209|BG003|Baseline|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
11005396|NCT01080209|BG004|Baseline|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
11005397|NCT01080209|BG005|Baseline|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
11005398|NCT01080209|BG006|Baseline|Sham|Patients who received sham in a previous study.
11005399|NCT01080209|BG007|Baseline|Total|Total of all reporting groups
11005400|NCT01080209|FG000|Participant Flow|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
11005401|NCT01080209|FG001|Participant Flow|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
11005402|NCT01080209|FG002|Participant Flow|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
11005403|NCT01080209|FG003|Participant Flow|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
11005404|NCT01080209|FG004|Participant Flow|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
11005405|NCT01080209|FG005|Participant Flow|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
11005406|NCT01080209|FG006|Participant Flow|Sham|Patients who received sham in a previous study.
11005407|NCT01080209|OG000|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
11005408|NCT01080209|OG001|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
11005409|NCT01080209|OG002|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
11005410|NCT01080209|OG003|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
11005411|NCT01080209|OG004|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
11005412|NCT01080209|OG005|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
11005413|NCT01080209|OG006|Outcome|Sham|Patients who received sham in a previous study.
10846068|NCT00272844|FG000|Participant Flow|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
11005414|NCT01080209|EG000|Reported Event|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
11005415|NCT01080209|EG001|Reported Event|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
11005416|NCT01080209|EG002|Reported Event|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
11005417|NCT01080209|EG003|Reported Event|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
11005418|NCT01080209|EG004|Reported Event|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
11005419|NCT01080209|EG005|Reported Event|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
11005420|NCT01080209|EG006|Reported Event|Sham|Patients who received sham in a previous study.
11005421|NCT01080248|BG000|Baseline|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
11005422|NCT01080248|FG000|Participant Flow|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
11005423|NCT01080248|OG000|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
11005424|NCT01080248|EG000|Reported Event|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
11005425|NCT01080261|BG000|Baseline|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
11005426|NCT01080261|FG000|Participant Flow|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
11005427|NCT01080261|OG000|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
11005428|NCT01080261|EG000|Reported Event|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
11005429|NCT01080300|BG000|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
11005430|NCT01080300|BG001|Baseline|Sugar Pill|Placebo 1800 mg
11005431|NCT01080300|BG002|Baseline|Total|Total of all reporting groups
11005432|NCT01080300|FG000|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
11005433|NCT01080300|FG001|Participant Flow|Sugar Pill|Placebo 1800 mg
11005434|NCT01080300|OG000|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
11005435|NCT01080300|OG001|Outcome|Sugar Pill|Placebo 1800 mg
11115236|NCT01673490|OG000|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
11115237|NCT01673490|EG000|Reported Event|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
11115238|NCT01673568|BG000|Baseline|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
11115239|NCT01673568|BG001|Baseline|no Abdominal Binder|no abdominal binder was warn
11115240|NCT01673568|BG002|Baseline|Total|Total of all reporting groups
11115241|NCT01673568|FG000|Participant Flow|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
11115242|NCT01673568|FG001|Participant Flow|no Abdominal Binder|no abdominal binder
11115243|NCT01673568|OG000|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
11115244|NCT01673568|OG001|Outcome|no Abdominal Binder|no abdominal binder
11115245|NCT01673568|EG000|Reported Event|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
11115246|NCT01673568|EG001|Reported Event|no Abdominal Binder|no abdominal binder
11115247|NCT01673594|BG000|Baseline|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
11115248|NCT01673594|BG001|Baseline|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
11115249|NCT01673594|BG002|Baseline|Total|Total of all reporting groups
11115250|NCT01673594|FG000|Participant Flow|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
11115251|NCT01673594|FG001|Participant Flow|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
11115252|NCT01673594|OG000|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
11115253|NCT01673594|OG001|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
11115254|NCT01673594|EG000|Reported Event|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
11115255|NCT01673594|EG001|Reported Event|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
11348338|NCT04182958|BG000|Baseline|Overall: (14C)-OPC-61815|Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
11115256|NCT01673646|BG000|Baseline|Pasireotide LAR 20mg|Enrolled patients were randomized to 20mg pasireotide LAR.
11115257|NCT01673646|BG001|Baseline|Pasireotide LAR 40mg|Enrolled patients were randomized to 40mg pasireotide LAR.
11115258|NCT01673646|BG002|Baseline|Pasireotide LAR 60mg|Enrolled patients were randomized to 60mg pasireotide LAR.
11115259|NCT01673646|BG003|Baseline|Total|Total of all reporting groups
11115260|NCT01673646|FG000|Participant Flow|Pasireotide LAR 20mg|Enrolled patients were randomized to 20mg pasireotide LAR.
11115261|NCT01673646|FG001|Participant Flow|Pasireotide LAR 40mg|Enrolled patients were randomized to 40mg pasireotide LAR.
11115262|NCT01673646|FG002|Participant Flow|Pasireotide LAR 60mg|Enrolled patients were randomized to 60mg pasireotide LAR.
11115263|NCT01673646|OG000|Outcome|Pasireotide LAR - All Participants|All patients randomized regardless of pasireotide LAR dose.
11115264|NCT01673646|OG000|Outcome|Pasireotide LAR 20mg|Enrolled patients were randomized to 20mg pasireotide LAR.
11115265|NCT01673646|OG001|Outcome|Pasireotide LAR 40mg|Enrolled patients were randomized to 40mg pasireotide LAR.
11115266|NCT01673646|OG002|Outcome|Pasireotide LAR 60mg|Enrolled patients were randomized to 60mg pasireotide LAR.
11115267|NCT01673646|OG000|Outcome|SSA Uncontrolled|Somatostatin analogue (SSA) uncontrolled population composes of patients who were pre-treated with SSA for >= 12 weeks.
11348339|NCT04182958|FG000|Participant Flow|Overall: (14C)-OPC-61815|Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
11348340|NCT04182958|OG000|Outcome|Overall: (14C)-OPC-61815|Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
11005436|NCT01080300|OG000|Outcome|Gabapentin Extended Release|"Active treatment~Gabapentin Extended Release: Gabapentin ER 1800mg daily"
11005437|NCT01080300|OG001|Outcome|Placebo|"Placebo~Placebo: Sugar pill"
11005438|NCT01080300|EG000|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
11005439|NCT01080300|EG001|Reported Event|Sugar Pill|Placebo 1800 mg
11005440|NCT01080326|BG000|Baseline|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
11005441|NCT01080326|FG000|Participant Flow|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
11005442|NCT01080326|OG000|Outcome|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
11005443|NCT01080326|EG000|Reported Event|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
11005444|NCT01080391|BG000|Baseline|Lenalidomide and Dexamethasone (Rd)|Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
11005445|NCT01080391|BG001|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
11005446|NCT01080391|BG002|Baseline|Total|Total of all reporting groups
11005447|NCT01080391|FG000|Participant Flow|Lenalidomide and Dexamethasone (Rd)|Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
11005448|NCT01080391|FG001|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
11005449|NCT01080391|OG000|Outcome|Lenalidomide and Dexamethasone (Rd)|Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
11005450|NCT01080391|OG001|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
11005451|NCT01080391|EG000|Reported Event|Lenalidomide and Dexamethasone (Rd)|Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
11007873|NCT01093534|FG001|Participant Flow|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
11115268|NCT01673646|OG001|Outcome|Others|Patients who were pre-treated with SSA for < 12 weeks or were not pre-treated with SSA are considered as others.
11115269|NCT01673646|EG000|Reported Event|Pasireotide LAR 20mg|Enrolled patients were randomized to 20mg pasireotide LAR.
11115270|NCT01673646|EG001|Reported Event|Pasireotide LAR 40mg|Enrolled patients were randomized to 40mg pasireotide LAR.
11115271|NCT01673646|EG002|Reported Event|Pasireotide LAR 60mg|Enrolled patients were randomized to 60mg pasireotide LAR.
11115272|NCT01673646|EG003|Reported Event|Pasireotide LAR - All Participants (All Patieents)|Patients who were randomized to the study - regardless of whether they were in the Core or Extension phase.
11115273|NCT01673698|BG000|Baseline|ReShape Duo Balloon|"ReShape Duo Balloon~ReShape Duo balloon~Diet counseling~Exercise counseling"
10846069|NCT00272844|OG000|Outcome|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
11115274|NCT01673698|BG001|Baseline|Sham Comparator|"Sham Comparator~Diet counseling~Exercise counseling"
11115275|NCT01673698|BG002|Baseline|Total|Total of all reporting groups
11115276|NCT01673698|FG000|Participant Flow|ReShape Duo Balloon|"ReShape Duo Balloon~ReShape Duo balloon~Diet counseling~Exercise counseling"
11115277|NCT01673698|FG001|Participant Flow|Sham Comparator|"Sham Comparator~Diet counseling~Exercise counseling"
11115278|NCT01673698|OG000|Outcome|Treatment|Treatment group
11115279|NCT01673698|OG001|Outcome|Control|Control group
11115280|NCT01673698|OG000|Outcome|Intent-to-Treat|Intent-to-Treat population
11115281|NCT01673698|EG000|Reported Event|Treatment Subjects|Subjects who were randomized and received a balloon during weeks 0-24
11115282|NCT01673698|EG001|Reported Event|Control Subjects|Subjects who were randomized to diet and exercise counseling only during weeks 0-24
11115283|NCT01673802|BG000|Baseline|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
11115284|NCT01673802|FG000|Participant Flow|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
11115285|NCT01673802|OG000|Outcome|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
11115286|NCT01673802|EG000|Reported Event|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
11115287|NCT01673828|BG000|Baseline|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days~Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
11115288|NCT01673828|BG001|Baseline|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days~Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
11115289|NCT01673828|BG002|Baseline|Total|Total of all reporting groups
11115290|NCT01673828|FG000|Participant Flow|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days~Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
11115291|NCT01673828|FG001|Participant Flow|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days~Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
11115292|NCT01673828|OG000|Outcome|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days~Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
11115293|NCT01673828|OG001|Outcome|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days~Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
11115294|NCT01673828|EG000|Reported Event|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days~Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
11005452|NCT01080391|EG001|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
11005453|NCT01080625|BG000|Baseline|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
11005454|NCT01080625|BG001|Baseline|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
11005455|NCT01080625|BG002|Baseline|Control|10 ml of normal saline is administered at the time of reperfusion
11005456|NCT01080625|BG003|Baseline|Total|Total of all reporting groups
11005457|NCT01080625|FG000|Participant Flow|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
11005458|NCT01080625|FG001|Participant Flow|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
11005459|NCT01080625|FG002|Participant Flow|Control|10 ml of normal saline is administered at the time of reperfusion
11005460|NCT01080625|OG000|Outcome|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
11005461|NCT01080625|OG001|Outcome|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
11005462|NCT01080625|OG002|Outcome|Control|10 ml of normal saline is administered at the time of reperfusion
11005463|NCT01080625|EG000|Reported Event|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
11005464|NCT01080625|EG001|Reported Event|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
11005465|NCT01080625|EG002|Reported Event|Control|10 ml of normal saline is administered at the time of reperfusion
11005466|NCT01080677|BG000|Baseline|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
11005467|NCT01080677|BG001|Baseline|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
11005468|NCT01080677|BG002|Baseline|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
11005469|NCT01080677|BG003|Baseline|Total|Total of all reporting groups
11005470|NCT01080677|FG000|Participant Flow|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
11005471|NCT01080677|FG001|Participant Flow|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
11005472|NCT01080677|FG002|Participant Flow|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
11005473|NCT01080677|OG000|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
11005474|NCT01080677|OG001|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
11005475|NCT01080677|OG002|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
11005476|NCT01080677|EG000|Reported Event|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
11005477|NCT01080677|EG001|Reported Event|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
11005478|NCT01080677|EG002|Reported Event|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
11005479|NCT01080716|BG000|Baseline|Part 1/Arm 1 of Study: WRSS1 Vaccine|"WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei~Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1"
11005480|NCT01080716|BG001|Baseline|Part 1/Arm 2 of Study: Placebo Vaccine|Placebo comparator
11005481|NCT01080716|BG002|Baseline|Part 2/Arm 1 of Study: S. Sonnei 53G|10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
11005482|NCT01080716|BG003|Baseline|Part 2/Arm 2 of Study: S Sonnei 53G (Controls)|10 subjects (naïve controls) given S. sonnei 53G
11005483|NCT01080716|BG004|Baseline|Total|Total of all reporting groups
11005484|NCT01080716|FG000|Participant Flow|Arm 1: WRSS1 Vaccine|WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S. sonnei
11005485|NCT01080716|FG001|Participant Flow|Arm 1: Placebo Vaccine|Placebo comparator
11005486|NCT01080716|FG002|Participant Flow|Arm 2: S. Sonnei 53G|10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given S. sonnei 53G
11005487|NCT01080716|FG003|Participant Flow|Arm 2: S. Sonnei 53G (Naive Subjects)|10 naïve controls given S. sonnei 53G
11005488|NCT01080716|OG000|Outcome|Part 1/Arm 1 of Study: WRSS1 Vaccine|"WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei~Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1"
11005489|NCT01080716|OG001|Outcome|Part 1/Arm 2 of Study: Placebo Vaccine|Placebo comparator
11005490|NCT01080716|OG002|Outcome|Part 2/Arm 1 of Study: S. Sonnei 53G|10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
11005491|NCT01080716|OG003|Outcome|Part 2/Arm 2 of Study: S Sonnei 53G (Controls)|10 subjects (naïve controls) given S. sonnei 53G
11005492|NCT01080716|OG000|Outcome|Part 2/Arm 1 of Study: S. Sonnei 53G|10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
11005493|NCT01080716|OG001|Outcome|Part 2/Arm 2 of Study: S Sonnei 53G (Controls)|10 subjects (naïve controls) given S. sonnei 53G
11005494|NCT01080716|OG000|Outcome|Subjects From Part 1 of Study|Analysis of abnormal clinical laboratory values in subjects from Part 1 of study
11005495|NCT01080716|OG001|Outcome|Subjects From Part 2 of Study|Analysis of abnormal clinical laboratory values in subjects from Part 2 of study
11005496|NCT01080716|EG000|Reported Event|Part 1/Arm 1 of Study: WRSS1 Vaccine|"WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei~Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1"
11005497|NCT01080716|EG001|Reported Event|Part 1/Arm 2: Placebo|Placebo comparator
11005498|NCT01080716|EG002|Reported Event|Part 2/Arm 1 of Study: S. Sonnei 53G|10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
11005499|NCT01080716|EG003|Reported Event|Part 2/Arm 2 of Study: S Sonnei 53G (Controls)|10 subjects (naïve controls) given S. sonnei 53G
11115295|NCT01673828|EG001|Reported Event|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days~Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
11115296|NCT01673854|BG000|Baseline|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
11115297|NCT01673854|FG000|Participant Flow|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
11115298|NCT01673854|OG000|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
11115299|NCT01673854|EG000|Reported Event|Vemurafenib, 960 mg + Ipilimumab,10 mg/kg ab|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
11115300|NCT01673893|BG000|Baseline|ST Elevation Myocardial Infarction|"The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.~1st Group/Cohort - STEMI: ST elevation myocardial infarction"
11115301|NCT01673893|BG001|Baseline|Non ST Elevation Myocardial Infarction/ACS/UNSTABLE ANGINA|"The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.~2nd Group/Cohort - NSTEMI: Non-ST elevation myocardial infarction/ACS/Unstable Angina"
11115302|NCT01673893|BG002|Baseline|Total|Total of all reporting groups
11115303|NCT01673893|FG000|Participant Flow|Readmission Results|"The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.~ClearWay™ Rx catheter"
11115304|NCT01673893|OG000|Outcome|No. Re-admission Within 30-days Post Pci|No. of Re-admission within 30-days post pci
11115305|NCT01673893|OG001|Outcome|No. of Cardiovascular Admissions Within 30-days|No. of Cardiovascular Admissions within 30-days: not preplanned, not elective
11115306|NCT01673893|OG002|Outcome|No. of Patients Compliant With DAPT|No. of patients compliant with Dual Anti Platelet Therapy
11115307|NCT01673893|EG000|Reported Event||Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed on 7 participants with re-admissions within 30 days post pci and 3 participants who had Cardiovascular Admissions within 30-days that were not preplanned or elective. Re-admissions were captured for data purposes only, not followed.
11115308|NCT01673919|BG000|Baseline|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
11115309|NCT01673919|FG000|Participant Flow|Tocilizumab (8 mg/kg)|Eligible participants received tocilizumab (TCZ) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in France, whichever came first.
11115310|NCT01673919|OG000|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
11115311|NCT01673919|EG000|Reported Event|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
11115312|NCT01673984|BG000|Baseline|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
11115313|NCT01673984|BG001|Baseline|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
11115314|NCT01673984|BG002|Baseline|Total|Total of all reporting groups
11115315|NCT01673984|FG000|Participant Flow|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
11115316|NCT01673984|FG001|Participant Flow|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
11115317|NCT01673984|OG000|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
11115318|NCT01673984|OG001|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
11115319|NCT01673984|EG000|Reported Event|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
11115320|NCT01673984|EG001|Reported Event|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
11115321|NCT01674010|BG000|Baseline|All Study Participants|
11115322|NCT01674010|FG000|Participant Flow|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
11115323|NCT01674010|FG001|Participant Flow|Phase 2 Placebo|Double Blind Randomization (Phase 2)
11115324|NCT01674010|FG002|Participant Flow|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
11115325|NCT01674010|OG000|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
11115326|NCT01674010|OG001|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
11115327|NCT01674010|OG002|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
11115328|NCT01674010|EG000|Reported Event|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
11115329|NCT01674010|EG001|Reported Event|Phase 2 Placebo|Double Blind Randomization (Phase 2)
11115330|NCT01674010|EG002|Reported Event|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
11115331|NCT01674062|BG000|Baseline|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
11115332|NCT01674062|BG001|Baseline|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
11115333|NCT01674062|BG002|Baseline|Total|Total of all reporting groups
11115334|NCT01674062|FG000|Participant Flow|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via intravenous (IV) infusion as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 milligrams (mg) followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
11115335|NCT01674062|FG001|Participant Flow|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
11115336|NCT01674062|OG000|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
11115337|NCT01674062|OG000|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
11115338|NCT01674062|EG000|Reported Event|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
11115339|NCT01674062|EG001|Reported Event|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
11115340|NCT01674478|BG000|Baseline|Microlipid and Fish Oil Group|"This group will be given early enteral lipid supplementation with Microlipid and fish oil.~Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis."
11115341|NCT01674478|BG001|Baseline|Microlipid Group|"This group will be given early enteral lipid supplementation only with Microlipid.~Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis."
11115342|NCT01674478|BG002|Baseline|Total|Total of all reporting groups
11115343|NCT01674478|FG000|Participant Flow|Microlipid and Fish Oil Group|"This group will be given early enteral lipid supplementation with Microlipid and fish oil.~Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis."
11115344|NCT01674478|FG001|Participant Flow|Microlipid Group|"This group will be given early enteral lipid supplementation only with Microlipid.~Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis."
11115345|NCT01674478|OG000|Outcome|Microlipid and Fish Oil Group|"This group will be given early enteral lipid supplementation with Microlipid and fish oil.~Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis."
11115346|NCT01674478|OG001|Outcome|Microlipid Group|"This group will be given early enteral lipid supplementation only with Microlipid.~Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis."
11115347|NCT01674478|EG000|Reported Event|Microlipid and Fish Oil Group|"This group will be given early enteral lipid supplementation with Microlipid and fish oil.~Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis."
11115348|NCT01674478|EG001|Reported Event|Microlipid Group|"This group will be given early enteral lipid supplementation only with Microlipid.~Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis."
11115349|NCT01674569|BG000|Baseline|Dose Escalation of X-82 and Ranibizumab Rescue|"Groups of participants were assigned to 1 of 6 X-82 doses over 24weeks,with an additional 4 weeks for follow-up. The dose escalated from one level to the next in the absence of any dose-limiting toxicity (DLT) defined as a drug-related safety event during the first 2 weeks of treatment that was severe enough to require removal of the participant from the study.~The escalating X82 oral dose regimens were 50 mg alternate days, 50 mg daily, 100 mg alternate days, 100mg daily, 200mg daily, and 300mg daily."
11115350|NCT01674569|FG000|Participant Flow|50 mg X82 Alternate Days|Participants were assigned to 50 mg X-82 on alternate days for 24 weeks. After treatment discontinuation subjects were followed for an additional 4 weeks.
11115351|NCT01674569|FG001|Participant Flow|50 mg X82 QD|Participants were assigned to 50 mg X-82 QD for 24 weeks. After treatment discontinuation subjects were followed for an additional 4 weeks.
11115352|NCT01674569|FG002|Participant Flow|100 mg X82 on Alternate Days|Participants were assigned to 100 mg X-82 on alternate days for 24 weeks. After treatment discontinuation subjects were followed for an additional 4 weeks.
11115353|NCT01674569|FG003|Participant Flow|100 mg X82 QD|Participants were assigned to 100 mg X-82 QD for 24 weeks. After treatment discontinuation subjects were followed for an additional 4 weeks.
11115354|NCT01674569|FG004|Participant Flow|200 mg X82 QD|Participants were assigned to 200 mg X-82 QD for 24 weeks. After treatment discontinuation subjects were followed for an additional 4 weeks.
11115355|NCT01674569|FG005|Participant Flow|300 mg X82 QD|Participants were assigned to 300 mg X-82 QD for 24 weeks. After treatment discontinuation subjects were followed for an additional 4 weeks.
11115356|NCT01674569|OG000|Outcome|All Completers|All subjects who successfully completed 6 months of treatment with oral X82
11115357|NCT01674569|EG000|Reported Event|Dose Escalation of X-82 and Ranibizumab Rescue|"Groups of participants were assigned to 1 of 6 X-82 doses over 24 weeks,with an additional 4 weeks for follow-up. The dose escalated from one level to the next in the absence of any dose-limiting toxicity (DLT) defined as a drug-related safety event during the first 2 weeks of treatment that was severe enough to require removal of the participant from the study.~The escalating X82 oral dose regimens were 50 mg alternate days, 50 mg daily, 100 mg alternate days, 100mg daily, 200mg daily, and 300mg daily."
11115358|NCT01674621|BG000|Baseline|Abaloparatide Transdermal (50 mcg)|Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
11115359|NCT01674621|BG001|Baseline|Abaloparatide Transdermal (100 mcg)|Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
11115360|NCT01674621|BG002|Baseline|Abaloparatide Transdermal (150 mcg)|Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
11115361|NCT01674621|BG003|Baseline|Abaloparatide Injection (80 mcg)|Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
11115362|NCT01674621|BG004|Baseline|Abaloparatide Transdermal Placebo (0 mcg)|Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
11115363|NCT01674621|BG005|Baseline|Total|Total of all reporting groups
11115364|NCT01674621|FG000|Participant Flow|Abaloparatide Transdermal (50 mcg)|Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
11115365|NCT01674621|FG001|Participant Flow|Abaloparatide Transdermal (100 mcg)|Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
11115366|NCT01674621|FG002|Participant Flow|Abaloparatide Transdermal (150 mcg)|Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
11115367|NCT01674621|FG003|Participant Flow|Abaloparatide Injection (80 mcg)|Abaloparatide-Subcutaneous (SC) Injection - 80 mcg daily injections for up to 6 months
11115368|NCT01674621|FG004|Participant Flow|Abaloparatide Transdermal Placebo (0 mcg)|Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
11115369|NCT01674621|OG000|Outcome|Abaloparatide Transdermal (50 mcg)|Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
11115370|NCT01674621|OG001|Outcome|Abaloparatide Transdermal (100 mcg)|Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
11115371|NCT01674621|OG002|Outcome|Abaloparatide Transdermal (150 mcg)|Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
11115372|NCT01674621|OG003|Outcome|Abaloparatide Injection (80 mcg)|Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
11115373|NCT01674621|OG004|Outcome|Abaloparatide Transdermal Placebo (0 mcg)|Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
11115374|NCT01674621|OG000|Outcome|Abaloparatide Transdermal (50 mcg)|Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
11115375|NCT01674621|EG000|Reported Event|Abaloparatide Transdermal (50 mcg)|Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
11115376|NCT01674621|EG001|Reported Event|Abaloparatide Transdermal (100 mcg)|Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
11115377|NCT01674621|EG002|Reported Event|Abaloparatide Transdermal (150 mcg)|Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
11115378|NCT01674621|EG003|Reported Event|Abaloparatide Injection (80 mcg)|Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
11115379|NCT01674621|EG004|Reported Event|Abaloparatide Transdermal Placebo (0 mcg)|Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
11115380|NCT01674634|BG000|Baseline|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
11115381|NCT01674634|FG000|Participant Flow|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
11115382|NCT01674634|OG000|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
11115383|NCT01674634|OG000|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the metacarpophalangeal (MP) joint cord
11115384|NCT01674634|OG001|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the proximal interphalangeal (PIP) joint cord
11115385|NCT01674634|OG000|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the MP joint cord
11115386|NCT01674634|OG001|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the PIP joint cord
11115387|NCT01674634|EG000|Reported Event|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
11115388|NCT01674647|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
11115389|NCT01674647|BG001|Baseline|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
11115390|NCT01674647|BG002|Baseline|Total|Total of all reporting groups
11126723|NCT01735175|BG001|Baseline|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11126724|NCT01735175|BG002|Baseline|Total|Total of all reporting groups
11126725|NCT01735175|FG000|Participant Flow|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11007874|NCT01093534|FG002|Participant Flow|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
11007875|NCT01093534|OG000|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
11007876|NCT01093534|OG001|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
11007877|NCT01093534|OG002|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
11007878|NCT01093534|OG003|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
11007879|NCT01093534|EG000|Reported Event|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
11007880|NCT01093534|EG001|Reported Event|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
11007881|NCT01093534|EG002|Reported Event|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
11007898|NCT01093586|BG000|Baseline|Arm I|PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
11007899|NCT01093586|FG000|Participant Flow|Arm I|PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
11007900|NCT01093586|OG000|Outcome|Arm I|PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
11007901|NCT01093586|EG000|Reported Event|Arm I|PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
11007902|NCT01093599|BG000|Baseline|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
11007903|NCT01093599|BG001|Baseline|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
11007904|NCT01093599|BG002|Baseline|Total|Total of all reporting groups
11115391|NCT01674647|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
11115392|NCT01674647|FG001|Participant Flow|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
11115393|NCT01674647|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
11115394|NCT01674647|OG001|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
11115395|NCT01674647|EG000|Reported Event|Rivaroxaban (Xarelto; BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
11115396|NCT01674647|EG001|Reported Event|Vitamin K Antagonist|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
11115397|NCT01674712|BG000|Baseline|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
11115398|NCT01674712|BG001|Baseline|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
11115399|NCT01674712|BG002|Baseline|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
11115400|NCT01674712|BG003|Baseline|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
11115401|NCT01674712|BG004|Baseline|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
11115402|NCT01674712|BG005|Baseline|Total|Total of all reporting groups
11115403|NCT01674712|FG000|Participant Flow|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
11115404|NCT01674712|FG001|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
11115405|NCT01674712|FG002|Participant Flow|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
11115406|NCT01674712|FG003|Participant Flow|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
11115407|NCT01674712|FG004|Participant Flow|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
11115408|NCT01674712|OG000|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
11115409|NCT01674712|OG001|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
11115410|NCT01674712|OG002|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
11115411|NCT01674712|OG003|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
11115412|NCT01674712|OG004|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
11115413|NCT01674712|EG000|Reported Event|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
11115414|NCT01674712|EG001|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
11115415|NCT01674712|EG002|Reported Event|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
11115416|NCT01674712|EG003|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
11115417|NCT01674712|EG004|Reported Event|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
11115418|NCT01674725|BG000|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11115419|NCT01674725|BG001|Baseline|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
11115420|NCT01674725|BG002|Baseline|Total|Total of all reporting groups
11115421|NCT01674725|FG000|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11115422|NCT01674725|FG001|Participant Flow|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
11115423|NCT01674725|OG000|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11115424|NCT01674725|OG001|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
11115425|NCT01674725|EG000|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11115426|NCT01674725|EG001|Reported Event|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
11115427|NCT01675050|BG000|Baseline|Cyproheptadine Then Placebo|4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
11115428|NCT01675050|BG001|Baseline|Placebo Then Cyproheptadine|4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
10878638|NCT00453479|BG001|Baseline|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
11115429|NCT01675050|BG002|Baseline|Total|Total of all reporting groups
11115430|NCT01675050|FG000|Participant Flow|Cyproheptadine First, Then Placebo|4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
11115431|NCT01675050|FG001|Participant Flow|Sugar Pill First, Than Cyproheptadine|4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
11115432|NCT01675050|OG000|Outcome|All Participants Post Cyproheptadine|
11115433|NCT01675050|OG001|Outcome|All Participants Post Placebo|
11115434|NCT01675050|EG000|Reported Event|Cyproheptadine|All participants while on Cyproheptadine.
11115435|NCT01675050|EG001|Reported Event|Placebo|All participants while on Placebo.
11115436|NCT01675063|BG000|Baseline|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
11115437|NCT01675063|FG000|Participant Flow|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
11115438|NCT01675063|OG000|Outcome|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
11115439|NCT01675063|EG000|Reported Event|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
10878639|NCT00453479|BG002|Baseline|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10878640|NCT00453479|BG003|Baseline|Total|Total of all reporting groups
10878641|NCT00453479|FG000|Participant Flow|Placebo|Participants entered into Cohort I received single inhaled dose of dry powder inhaler (DPI) of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) and was formulated with lactose only as a vehicle to make 12.5 milligrams (mg).
10878642|NCT00453479|FG001|Participant Flow|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 micrograms (µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10878643|NCT00453479|FG002|Participant Flow|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10878644|NCT00453479|OG000|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
10878645|NCT00453479|OG001|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10878646|NCT00453479|OG002|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10878647|NCT00453479|OG000|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10878648|NCT00453479|OG001|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10878649|NCT00453479|EG000|Reported Event|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
10878650|NCT00453479|EG001|Reported Event|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10878651|NCT00453479|EG002|Reported Event|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
10879556|NCT00458484|BG000|Baseline|Series 1/Dose Level 1: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions: 6 Gy x 4 fractions total dose of 24 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879557|NCT00458484|BG001|Baseline|Series 1/Dose Level 2: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions: 8 Gy x 4 fractions total dose of 32 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879558|NCT00458484|BG002|Baseline|Series 1/Dose Level 3: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions: 10 Gy x 4 fractions total dose of 40 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879559|NCT00458484|BG003|Baseline|Series 1/Dose Level 4: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions: 12 Gy x 4 fractions total dose of 48 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879566|NCT00458484|FG002|Participant Flow|Series 1/Dose Level 3: Stereotactic Radiosurgery|"Dose Level 3: Radiation will be delivered in 4 fractions:~10 Gy x 4 fractions: Total of 40 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
11115440|NCT01675128|BG000|Baseline|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115441|NCT01675128|BG001|Baseline|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115442|NCT01675128|BG002|Baseline|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
11115443|NCT01675128|BG003|Baseline|Total|Total of all reporting groups
11115444|NCT01675128|FG000|Participant Flow|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115445|NCT01675128|FG001|Participant Flow|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115446|NCT01675128|FG002|Participant Flow|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
11115447|NCT01675128|OG000|Outcome|All Phase I Participants|ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115448|NCT01675128|OG000|Outcome|All Phase I Participants|Irinotecan 160 (and 180) mg/m^2 every other week.
11115449|NCT01675128|OG000|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
11115450|NCT01675128|OG000|Outcome|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115451|NCT01675128|OG001|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115452|NCT01675128|OG002|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
11115453|NCT01675128|OG000|Outcome|Phase I Dose Level 2|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115454|NCT01675128|OG001|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
11115455|NCT01675128|OG000|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115456|NCT01675128|OG000|Outcome|Phase I Dose Level I & Phase I Dose Level II|"Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.~Phase I Dose Level II Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks."
11115457|NCT01675128|EG000|Reported Event|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115458|NCT01675128|EG001|Reported Event|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
11115459|NCT01675128|EG002|Reported Event|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
11115460|NCT01675141|BG000|Baseline|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
11115461|NCT01675141|FG000|Participant Flow|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
11115462|NCT01675141|OG000|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
11115463|NCT01675141|EG000|Reported Event|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
11115464|NCT01675154|BG000|Baseline|Placebo/Placebo at First Intervention Period|"Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals.~Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals."
11115465|NCT01675154|BG001|Baseline|Orlistat/Placebo at First Intervention Period|Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals were administered.
11115466|NCT01675154|BG002|Baseline|Orlistat Placebo /Slx-4090 at First Intervention Period|Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals were administered
11115467|NCT01675154|BG003|Baseline|Orlistat/SLx-4090 at First Intervention Period|Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals were administered.
11115468|NCT01675154|BG004|Baseline|Total|Total of all reporting groups
11115469|NCT01675154|FG000|Participant Flow|SLx-4090 Placebo/Orlistat Placebo First|"First, SLx-4090 (placebo) is dosed as 4 tablets of 50 mg, three times per day with meals.~Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat Placebo: Given for 4 weeks"
11115470|NCT01675154|FG001|Participant Flow|Orlistat/SLx-4090 Placebo|"Then, Orlistat two capsules 60 mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50 mg each, three times per day with meals were administered~SLx-4090 placebo: Given for 4 weeks~Orlistat: Given for 4 weeks"
11115471|NCT01675154|FG002|Participant Flow|Orlistat Placebo /SLx-4090|"Then, Orlistat placebo 2 capsules, 60 mg each three times per day with meals. SLx-4090 4 tablets, 50 mg each. three times per day with meals were administered~Orlistat Placebo: Given for 4 weeks~SLx-4090: Given for 4 weeks"
11115472|NCT01675154|FG003|Participant Flow|Orlistat/SLx-4090|"Then, Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50 mg each, three times per day with meals were administered~Orlistat: Given for 4 weeks~SLx-4090: Given for 4 weeks"
11115473|NCT01675154|OG000|Outcome|SLx-4090 Placebo/Orlistat Placebo|"Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals.~Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat Placebo: Given for 4 weeks"
11115474|NCT01675154|OG001|Outcome|Orlistat/Placebo|"Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat: Given for 4 weeks"
11115475|NCT01675154|OG002|Outcome|Orlistat Placebo /Slx-4090|"Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals.~Orlistat Placebo: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115476|NCT01675154|OG003|Outcome|Orlistat/SLx-4090|"Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.~Orlistat: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115477|NCT01675154|EG000|Reported Event|1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo|"Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals.~Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat Placebo: Given for 4 weeks"
11115478|NCT01675154|EG001|Reported Event|1st Intervention Period:Orlistat/Placebo|"Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat: Given for 4 weeks"
11115479|NCT01675154|EG002|Reported Event|1st Intervention Period:Orlistat Placebo /Slx-4090|"Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals.~Orlistat Placebo: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115480|NCT01675154|EG003|Reported Event|1st Intervention Period:Orlistat/SLx-4090|"Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.~Orlistat: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115481|NCT01675154|EG004|Reported Event|2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo|"Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals.~Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat Placebo: Given for 4 weeks"
11115482|NCT01675154|EG005|Reported Event|2nd Intervention Period:Orlistat/Placebo|"Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat: Given for 4 weeks"
11115483|NCT01675154|EG006|Reported Event|2nd Intervention Period:Orlistat Placebo /Slx-4090|"Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.~Orlistat: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115484|NCT01675154|EG007|Reported Event|2nd Intervention Period:Orlistat/SLx-4090|"Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.~Orlistat: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115485|NCT01675154|EG008|Reported Event|3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo|"Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals.~Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat Placebo: Given for 4 weeks"
11115486|NCT01675154|EG009|Reported Event|3rd Intervention Period:Orlistat/Placebo|"Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat: Given for 4 weeks"
11115487|NCT01675154|EG010|Reported Event|3rd Intervention Period:Orlistat Placebo /Slx-4090|"Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.~Orlistat: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115488|NCT01675154|EG011|Reported Event|3rd Intervention Period:Orlistat/SLx-4090|"Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.~Orlistat: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115489|NCT01675154|EG012|Reported Event|4th Intervention Period:SLx-4090 Placebo/Orlistat Placebo|"Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals.~Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat Placebo: Given for 4 weeks"
11115490|NCT01675154|EG013|Reported Event|4th Intervention Period:Orlistat/Placebo|"Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals.~SLx-4090 placebo: Given for 4 weeks~Orlistat: Given for 4 weeks"
11115491|NCT01675154|EG014|Reported Event|4th Intervention Period:Orlistat Placebo /Slx-4090|"Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.~Orlistat: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115492|NCT01675154|EG015|Reported Event|4th Intervention Period:Orlistat/SLx-4090|"Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.~Orlistat: Given for 4 weeks~Slx-4090: Given for 4 weeks"
11115493|NCT01675167|BG000|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11115494|NCT01675167|BG001|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11115495|NCT01675167|BG002|Baseline|Total|Total of all reporting groups
11115496|NCT01675167|FG000|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
11115497|NCT01675167|FG001|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11115498|NCT01675167|FG002|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11115499|NCT01675167|OG000|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11115500|NCT01675167|OG001|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11115501|NCT01675167|OG000|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
11115502|NCT01675167|EG000|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
11115503|NCT01675167|EG001|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
11115504|NCT01675167|EG002|Reported Event|DB Placebo Film|Placebo buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
11115505|NCT01675297|BG000|Baseline|Risendronate/Cholecalciferol Combination|"Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months~Risedronate/Cholecalciferol combination: Risendronate/Cholecalciferol combination once a week"
11115506|NCT01675297|BG001|Baseline|Risedronate|"Sedron tablet: one tablet once a week for 12months~Risedronate: Risedronate once a week"
11115507|NCT01675297|BG002|Baseline|Total|Total of all reporting groups
11115508|NCT01675297|FG000|Participant Flow|Risendronate/Cholecalciferol Combination|"Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.~Risedronate/Cholecalciferol combination: once a week"
11115509|NCT01675297|FG001|Participant Flow|Risedronate|"Active comparator: Administer Risendronate one tablet once a week for 12months.~Risedronate: once a week"
11115510|NCT01675297|OG000|Outcome|Risendronate/Cholecalciferol Combination|"Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.~Risedronate/Cholecalciferol combination: once a week"
11115511|NCT01675297|OG001|Outcome|Risedronate|"Active comparator: Administer Risendronate one tablet once a week for 12months.~Risedronate: once a week"
11115512|NCT01675297|EG000|Reported Event|Risendronate/Cholecalciferol Combination|"Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.~Risedronate/Cholecalciferol combination: once a week"
11115513|NCT01675297|EG001|Reported Event|Risedronate|"Active comparator: Administer Risendronate one tablet once a week for 12months.~Risedronate: once a week"
11115514|NCT01675427|BG000|Baseline|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
11115515|NCT01675427|FG000|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
11115516|NCT01675427|OG000|Outcome|Naive: IL28B rs12979860 Cysteine-Cysteine (CC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
11115517|NCT01675427|OG001|Outcome|Naive: IL28B rs12979860 Threonine-Cysteine (TC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
11115518|NCT01675427|OG002|Outcome|Naive: IL28B rs12979860 Threonine-Threonine (TT)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
11115519|NCT01675427|OG000|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
11115520|NCT01675427|OG001|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
11115521|NCT01675427|OG002|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
11115522|NCT01675427|OG000|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
11115523|NCT01675427|OG001|Outcome|Naive: IL28B rs8099917 Threonine-Glycine (TG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
11115524|NCT01675427|OG002|Outcome|Naive: IL28B rs8099917 Glycine-Glycine (GG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
11115525|NCT01675427|OG000|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
11115526|NCT01675427|OG001|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
11115527|NCT01675427|OG002|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
11115528|NCT01675427|OG000|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
11115529|NCT01675427|OG001|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
11115530|NCT01675427|OG002|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
11115531|NCT01675427|OG001|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
11115532|NCT01675427|OG002|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
11115533|NCT01675427|OG000|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
11115534|NCT01675427|OG001|Outcome|Naive: ITPA rs7270101 Alanine-Cysteine (AC)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
11115535|NCT01675427|OG002|Outcome|Naive: ITPA rs7270101 Alanine-Alanine (AA)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
11115536|NCT01675427|OG000|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
11115537|NCT01675427|OG001|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
11115538|NCT01675427|OG002|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
11115539|NCT01675427|OG000|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
11115540|NCT01675427|OG001|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
11115541|NCT01675427|OG002|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
11115542|NCT01675427|OG000|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
11115543|NCT01675427|OG001|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
11115544|NCT01675427|OG002|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
11115545|NCT01675427|OG001|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
11115546|NCT01675427|OG002|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
11115547|NCT01675427|EG000|Reported Event|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
11115548|NCT01675453|BG000|Baseline|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
11115549|NCT01675453|BG001|Baseline|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
11115550|NCT01675453|BG002|Baseline|Total|Total of all reporting groups
11115551|NCT01675453|FG000|Participant Flow|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
11115552|NCT01675453|FG001|Participant Flow|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
11115553|NCT01675453|OG000|Outcome|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
11115554|NCT01675453|OG001|Outcome|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
11115555|NCT01675453|EG000|Reported Event|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
11115556|NCT01675453|EG001|Reported Event|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
11115557|NCT01675492|BG000|Baseline|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
11115558|NCT01675492|FG000|Participant Flow|Wave-front Guided LASIK|Vision correction for a mixed astigmatism refraction
11115559|NCT01675492|OG000|Outcome|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction
11115560|NCT01675492|OG000|Outcome|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
11115561|NCT01675492|EG000|Reported Event|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
11115562|NCT01675531|BG000|Baseline|Oxycodone/Naloxone|"Targin~Targin: Single arm for Targin"
11115563|NCT01675531|FG000|Participant Flow|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
11115564|NCT01675531|OG000|Outcome|Oxycodone/Naloxone|"Targin~Targin: Single arm for Targin"
11115565|NCT01675531|OG000|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
11115566|NCT01675531|EG000|Reported Event|Oxycodone/Naloxone|"Targin(Oxycodone/Naloxone)~Targin: Single arm for Targin"
11115567|NCT01675544|BG000|Baseline|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
11115568|NCT01675544|FG000|Participant Flow|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
11115569|NCT01675544|OG000|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
11115570|NCT01675544|EG000|Reported Event|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
11126726|NCT01735175|FG001|Participant Flow|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11126727|NCT01735175|OG000|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11126728|NCT01735175|OG001|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11126729|NCT01735175|EG000|Reported Event|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11126730|NCT01735175|EG001|Reported Event|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11126731|NCT01735201|BG000|Baseline|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
11126732|NCT01735201|BG001|Baseline|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
11126733|NCT01735201|BG002|Baseline|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
11126734|NCT01735201|BG003|Baseline|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
11126735|NCT01735201|BG004|Baseline|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
11126736|NCT01735201|BG005|Baseline|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
11126737|NCT01735201|BG006|Baseline|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
11126738|NCT01735201|BG007|Baseline|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
11126739|NCT01735201|BG008|Baseline|Total|Total of all reporting groups
11126740|NCT01735201|FG000|Participant Flow|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
11126741|NCT01735201|FG001|Participant Flow|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
11126742|NCT01735201|FG002|Participant Flow|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
11126743|NCT01735201|FG003|Participant Flow|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
11126744|NCT01735201|FG004|Participant Flow|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
11126745|NCT01735201|FG005|Participant Flow|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
11126746|NCT01735201|FG006|Participant Flow|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
11126747|NCT01735201|FG007|Participant Flow|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
11126748|NCT01735201|OG000|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
11126749|NCT01735201|OG001|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
11126750|NCT01735201|OG002|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
11126751|NCT01735201|OG003|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
11126752|NCT01735201|OG004|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
11126753|NCT01735201|OG005|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
11126754|NCT01735201|OG006|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
11126755|NCT01735201|OG007|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
11126756|NCT01735201|EG000|Reported Event|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
11126757|NCT01735201|EG001|Reported Event|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
11126758|NCT01735201|EG002|Reported Event|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
11126759|NCT01735201|EG003|Reported Event|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
11126760|NCT01735201|EG004|Reported Event|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
11126761|NCT01735201|EG005|Reported Event|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
11126762|NCT01735201|EG006|Reported Event|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
11126763|NCT01735201|EG007|Reported Event|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
11115571|NCT01675596|BG000|Baseline|TAVR With SAPIEN XT THV|"SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.~TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects"
11115572|NCT01675596|FG000|Participant Flow|TAVR With SAPIEN XT THV|"SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.~TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects"
11115573|NCT01675596|OG000|Outcome|TAVR With SAPIEN XT THV|"SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.~TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects"
11115574|NCT01675596|EG000|Reported Event|TAVR With SAPIEN XT THV|"SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.~TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects"
11115575|NCT01675622|BG000|Baseline|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
11115576|NCT01675622|BG001|Baseline|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
11115577|NCT01675622|BG002|Baseline|Total|Total of all reporting groups
11115578|NCT01675622|FG000|Participant Flow|Oxycodone Capsules for Cancer Pain|"Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days. All patients completed the double-blind treatment entered into period 2.~period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets."
11115579|NCT01675622|FG001|Participant Flow|Morphine Tablets for Cancer Pain|"Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours. All patients completed the double-blind treatment entered into period 2.~period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets."
11115580|NCT01675622|OG000|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
11115581|NCT01675622|OG001|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
11115582|NCT01675622|EG000|Reported Event|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
11115583|NCT01675622|EG001|Reported Event|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
11115584|NCT01675635|BG000|Baseline|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours"
11115585|NCT01675635|BG001|Baseline|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
11115586|NCT01675635|BG002|Baseline|Total|Total of all reporting groups
11115587|NCT01675635|FG000|Participant Flow|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
11115588|NCT01675635|FG001|Participant Flow|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
11115589|NCT01675635|OG000|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
11115590|NCT01675635|OG001|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
11115591|NCT01675635|OG000|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
11115592|NCT01675635|OG001|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage:20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
11115593|NCT01675635|OG000|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours"
11115594|NCT01675635|OG001|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
11115595|NCT01675635|OG001|Outcome|Morphine Tablet:|"To determine the efficacy and safety of Morphine tablet.~dosage: 20mg dosage form: tablet; frequency: every 6h; duration: 24 hours."
11115596|NCT01675635|EG000|Reported Event|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours"
11115597|NCT01675635|EG001|Reported Event|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
11115598|NCT01675661|BG000|Baseline|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
11115599|NCT01675661|BG001|Baseline|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
11115600|NCT01675661|BG002|Baseline|Total|Total of all reporting groups
11115601|NCT01675661|FG000|Participant Flow|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
11115602|NCT01675661|FG001|Participant Flow|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
11115603|NCT01675661|OG000|Outcome|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
11115604|NCT01675661|OG001|Outcome|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
11115605|NCT01675661|EG000|Reported Event|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
11115606|NCT01675661|EG001|Reported Event|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
11115607|NCT01675765|BG000|Baseline|Immunotherapy Plus Chemotherapy|"Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)~Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)~Weeks 23 and 26: CRS-207~Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression~Immunotherapy plus chemotherapy: live attenuated double deleted Lm"
11115608|NCT01675765|BG001|Baseline|Immunotherapy With Cyclophosphamide Plus Chemotherapy|"Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)~Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)~Weeks 23 and 26: cyclophosphamide one day before CRS-207~Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression~Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm"
11115609|NCT01675765|BG002|Baseline|Total|Total of all reporting groups
10878652|NCT00453895|BG000|Baseline|Sunitinib|"Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.~treatment will continue until progressive disease or unacceptable toxicity~Sunitinib :"
10878653|NCT00453895|FG000|Participant Flow|Sunitinib|"Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.~treatment will continue until progressive disease or unacceptable toxicity~Sunitinib :"
10878654|NCT00453895|OG000|Outcome|Sunitinib|"Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.~treatment will continue until progressive disease or unacceptable toxicity~Sunitinib :"
10878655|NCT00453895|EG000|Reported Event|Sunitinib|"Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.~treatment will continue until progressive disease or unacceptable toxicity~Sunitinib :"
10878656|NCT00453921|BG000|Baseline|Placebo Both Conditions|Placebo as both treatments: Placebo capsules and Placebo Memory and Attention Training
10878657|NCT00453921|BG001|Baseline|Active Drug/Active Therapy|"Methylphenidate: Dosage dependent on weight~Memory and Attention Training: Weekly Memory and Attention Training with at home practice."
10878658|NCT00453921|BG002|Baseline|Active Drug/Placebo Therapy|Methylphenidate: Dosage dependent on weight
10878659|NCT00453921|BG003|Baseline|Placebo Drug/Active Therapy|Memory and Attention Training: Weekly Memory and Attention Training with at home practice.
10878660|NCT00453921|BG004|Baseline|Total|Total of all reporting groups
10878661|NCT00453921|FG000|Participant Flow|Placebo Both Conditions|"Placebo Capsule and Placebo Memory and Attention Training (Placebo as both conditions)~Placebo as both treatments: Placebo capsules and Placebo Memory and Attention Training"
10878662|NCT00453921|FG001|Participant Flow|Active Drug/Active Therapy|"Methylphenidate capsules and Memory and Attention Training (Active Med/Active therapy)~Methylphenidate: Dosage dependent on weight~Memory and Attention Training: Weekly Memory and Attention Training with at home practice."
10878663|NCT00453921|FG002|Participant Flow|Active Drug/Placebo Therapy|"Methylphenidate capsules and Placebo Memory and Attention Training (Active Med/Placebo therapy)~Methylphenidate: Dosage dependent on weight"
10878664|NCT00453921|FG003|Participant Flow|Placebo Drug/Active Therapy|"Placebo capsules and Memory and Attention Training (Placebo Med/Active therapy)~Memory and Attention Training: Weekly Memory and Attention Training with at home practice."
10878665|NCT00453921|OG000|Outcome|Placebo Both Conditions|Placebo as both treatments: Placebo capsules and Placebo Memory and Attention Training
10878666|NCT00453921|OG001|Outcome|Active Drug/Active Therapy|"Methylphenidate: Dosage dependent on weight~Memory and Attention Training: Weekly Memory and Attention Training with at home practice."
10878667|NCT00453921|OG002|Outcome|Active Drug/Placebo Therapy|Methylphenidate: Dosage dependent on weight
10878668|NCT00453921|OG003|Outcome|Placebo Drug/Active Therapy|Memory and Attention Training: Weekly Memory and Attention Training with at home practice.
10878669|NCT00453921|OG000|Outcome|Placebo Both Conditions|"Placebo Capsule and Placebo Memory and Attention Training (Placebo as both conditions)~Placebo as both treatments: Placebo capsules and Placebo Memory and Attention Training"
10878670|NCT00453921|OG001|Outcome|Active Drug/Active Therapy|"Methylphenidate capsules and Memory and Attention Training (Active Med/Active therapy)~Methylphenidate: Dosage dependent on weight~Memory and Attention Training: Weekly Memory and Attention Training with at home practice."
10878671|NCT00453921|OG002|Outcome|Active Drug/Placebo Therapy|"Methylphenidate capsules and Placebo Memory and Attention Training (Active Med/Placebo therapy)~Methylphenidate: Dosage dependent on weight"
10878672|NCT00453921|OG003|Outcome|Placebo Drug/Active Therapy|"Placebo capsules and Memory and Attention Training (Placebo Med/Active therapy)~Memory and Attention Training: Weekly Memory and Attention Training with at home practice."
10878673|NCT00453921|EG000|Reported Event|Placebo Both Conditions|"Placebo Capsule and Placebo Memory and Attention Training (Placebo as both conditions)~Placebo as both treatments: Placebo capsules and Placebo Memory and Attention Training"
10878674|NCT00453921|EG001|Reported Event|Active Med/Active Therapy|"Methylphenidate capsules and Memory and Attention Training (Active Med/Active therapy)~Methylphenidate: Dosage dependent on weight~Memory and Attention Training: Weekly Memory and Attention Training with at home practice."
10878675|NCT00453921|EG002|Reported Event|Active Med/Placebo Therapy|"Methylphenidate capsules and Placebo Memory and Attention Training (Active Med/Placebo therapy)~Methylphenidate: Dosage dependent on weight"
10878676|NCT00453921|EG003|Reported Event|Placebo Med/Active Therapy|"Placebo capsules and Memory and Attention Training (Placebo Med/Active therapy)~Memory and Attention Training: Weekly Memory and Attention Training with at home practice."
10878677|NCT00453973|BG000|Baseline|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
10878678|NCT00453973|BG001|Baseline|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
10878679|NCT00453973|BG002|Baseline|Pooled AF37702 Inj.|
10878680|NCT00453973|FG000|Participant Flow|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
10878681|NCT00453973|FG001|Participant Flow|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
10878682|NCT00453973|OG000|Outcome|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
11115610|NCT01675765|FG000|Participant Flow|Immunotherapy Plus Chemotherapy|"Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)~Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)~Weeks 23 and 26: CRS-207~Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression~Immunotherapy plus chemotherapy: live attenuated double deleted Lm"
11115611|NCT01675765|FG001|Participant Flow|Immunotherapy With Cyclophosphamide Plus Chemotherapy|"Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)~Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)~Weeks 23 and 26: cyclophosphamide one day before CRS-207~Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression~Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm"
11115612|NCT01675765|OG000|Outcome|Immunotherapy Plus Chemotherapy|"Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)~Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)~Weeks 23 and 26: CRS-207~Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression~Immunotherapy plus chemotherapy: live attenuated double deleted Lm"
11115613|NCT01675765|OG001|Outcome|Immunotherapy With Cyclophosphamide Plus Chemotherapy|"Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)~Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)~Weeks 23 and 26: cyclophosphamide one day before CRS-207~Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression~Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm"
11115614|NCT01675765|EG000|Reported Event|Immunotherapy Plus Chemotherapy|"Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)~Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)~Weeks 23 and 26: CRS-207~Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression~Immunotherapy plus chemotherapy: live attenuated double deleted Lm"
11115615|NCT01675765|EG001|Reported Event|Immunotherapy With Cyclophosphamide Plus Chemotherapy|"Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)~Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)~Weeks 23 and 26: cyclophosphamide one day before CRS-207~Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression~Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm"
11115616|NCT01675778|BG000|Baseline|Hydromorphone|Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
11115617|NCT01675778|FG000|Participant Flow|Hydromorphone|Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
11115618|NCT01675778|OG000|Outcome|Hydromorphone|Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
11115619|NCT01675778|OG000|Outcome|Hydromorphone|"Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone. Pain scale change, patients' satisfaction, requirements for additional pain medications, side effects and adverse events will be recorded at 15 and 30 minutes. Patients' weight and height will be measured. Age, gender, and race/ethnicity will also be recorded. Blood draw for genetic study will be performed.~Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects"
11115620|NCT01675778|EG000|Reported Event|Hydromorphone|Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
11115621|NCT01675830|BG000|Baseline|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
11115622|NCT01675830|FG000|Participant Flow|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
11115623|NCT01675830|OG000|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
11115624|NCT01675830|EG000|Reported Event|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
11115625|NCT01675882|BG000|Baseline|Viaskin Peanut 50 μg|Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115626|NCT01675882|BG001|Baseline|Viaskin Peanut 100 μg|Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115627|NCT01675882|BG002|Baseline|Viaskin Peanut 250 μg|Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115628|NCT01675882|BG003|Baseline|Placebo|Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115629|NCT01675882|BG004|Baseline|Total|Total of all reporting groups
11115630|NCT01675882|FG000|Participant Flow|Viaskin Peanut 50 μg|Participants applied 1 new Viaskin® Peanut (DBV712) 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115631|NCT01675882|FG001|Participant Flow|Viaskin Peanut 100 μg|Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115632|NCT01675882|FG002|Participant Flow|Viaskin Peanut 250 μg|Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115633|NCT01675882|FG003|Participant Flow|Placebo|Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115634|NCT01675882|OG000|Outcome|Viaskin Peanut 50 μg|Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115635|NCT01675882|OG001|Outcome|Viaskin Peanut 100 μg|Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115636|NCT01675882|OG002|Outcome|Viaskin Peanut 250 μg|Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115637|NCT01675882|OG003|Outcome|Placebo|Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115638|NCT01675882|EG000|Reported Event|Viaskin Peanut 50 μg|Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115639|NCT01675882|EG001|Reported Event|Viaskin Peanut 100 μg|Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115640|NCT01675882|EG002|Reported Event|Viaskin Peanut 250 μg|Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115641|NCT01675882|EG003|Reported Event|Placebo|Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
11115642|NCT01676012|BG000|Baseline|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
11115643|NCT01676012|FG000|Participant Flow|Five Types of Bronchoscopy|"Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
11115644|NCT01676012|OG000|Outcome|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
11115645|NCT01676012|EG000|Reported Event|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
11115646|NCT01676116|BG000|Baseline|Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)|Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern.
11115647|NCT01676116|BG001|Baseline|Liraglutide or Exenatide + OADs|Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern.
11115648|NCT01676116|BG002|Baseline|Total|Total of all reporting groups
11115649|NCT01676116|FG000|Participant Flow|Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)|Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern.
11115650|NCT01676116|FG001|Participant Flow|Liraglutide or Exenatide + OADs|Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern.
11115651|NCT01676116|OG000|Outcome|Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)|Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern.
11115652|NCT01676116|OG001|Outcome|Liraglutide or Exenatide + OADs|Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern.
11115653|NCT01676116|EG000|Reported Event|Insulin Degludec/Liraglutide +OADs|Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Insulin degludec/liraglutide was dosed on an individual basis. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern.
11115654|NCT01676116|EG001|Reported Event|Liraglutide or Exenatide + OADs|Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern.
11115655|NCT01676220|BG000|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
11115656|NCT01676220|BG001|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
11115657|NCT01676220|BG002|Baseline|Total|Total of all reporting groups
11348341|NCT04182958|EG000|Reported Event|Overall: (14C)-OPC-61815|Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.
11115658|NCT01676220|FG000|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
11348342|NCT04179838|BG000|Baseline|Sleep-Deprived First, Then Non-Sleep Deprived|Participants will first be tested after 1 night with partial sleep deprivation (sleep-deprived, 4 h sleep). After a washout period of 4 weeks, they will be tested again after 1 night with normal sleep (non-sleep deprived, 8 h sleep).
11348343|NCT04179838|BG001|Baseline|Non-Sleep Deprived First, Then Sleep-deprived|Participants will first be tested after 1 night with normal sleep (non-sleep deprived, 8 h sleep). After a washout period of 4 weeks, they will be tested again after 1 night with partial sleep deprivation (sleep-deprived, 4 h sleep).
11005500|NCT01080794|BG000|Baseline|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005501|NCT01080794|BG001|Baseline|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005502|NCT01080794|BG002|Baseline|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005503|NCT01080794|BG003|Baseline|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005504|NCT01080794|BG004|Baseline|Total|Total of all reporting groups
11005505|NCT01080794|FG000|Participant Flow|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005506|NCT01080794|FG001|Participant Flow|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005507|NCT01080794|FG002|Participant Flow|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11348344|NCT04179838|BG002|Baseline|Total|Total of all reporting groups
11115659|NCT01676220|FG001|Participant Flow|Lantus (Insulin Glargine)|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
11115660|NCT01676220|OG000|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
11115661|NCT01676220|OG001|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
11115662|NCT01676220|OG000|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
11115663|NCT01676220|OG001|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
11115664|NCT01676220|EG000|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
11115665|NCT01676220|EG001|Reported Event|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
11115666|NCT01676298|BG000|Baseline|*1/*1 CYP2C19 Genotype|
11115667|NCT01676298|BG001|Baseline|*1/*2 CYP2C19 Genotype|
11115668|NCT01676298|BG002|Baseline|*2/*2 CYP2C19 Genotype|
11115669|NCT01676298|BG003|Baseline|*3/*1 CYP2C19 Genotype|
11115670|NCT01676298|BG004|Baseline|*1/*17 CYP2C19 Genotype|
11115671|NCT01676298|BG005|Baseline|*17/*17 CYP2C19 Genotype|
11115672|NCT01676298|BG006|Baseline|*2/*3 CYP2C19 Genotype|
11115673|NCT01676298|BG007|Baseline|*2/*17 CYP2C19 Genotype|
11115674|NCT01676298|BG008|Baseline|Total|Total of all reporting groups
11115675|NCT01676298|FG000|Participant Flow|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115676|NCT01676298|FG001|Participant Flow|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115677|NCT01676298|FG002|Participant Flow|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115678|NCT01676298|FG003|Participant Flow|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115679|NCT01676298|FG004|Participant Flow|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115680|NCT01676298|FG005|Participant Flow|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115681|NCT01676298|FG006|Participant Flow|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115682|NCT01676298|FG007|Participant Flow|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115683|NCT01676298|OG000|Outcome|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115684|NCT01676298|OG001|Outcome|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115685|NCT01676298|OG002|Outcome|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115686|NCT01676298|OG003|Outcome|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115687|NCT01676298|OG004|Outcome|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115688|NCT01676298|OG005|Outcome|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115689|NCT01676298|OG006|Outcome|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115690|NCT01676298|OG007|Outcome|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
11115691|NCT01676298|EG000|Reported Event|*1/*1 CYP2C19 Genotype|
11115692|NCT01676298|EG001|Reported Event|*1/*2 CYP2C19 Genotype|
11115693|NCT01676298|EG002|Reported Event|*2/*2 CYP2C19 Genotype|
11115694|NCT01676298|EG003|Reported Event|*3/*1 CYP2C19 Genotype|
11115695|NCT01676298|EG004|Reported Event|*1/*17 CYP2C19 Genotype|
11115696|NCT01676298|EG005|Reported Event|*17/*17 CYP2C19 Genotype|
11115697|NCT01676298|EG006|Reported Event|*2/*3 CYP2C19 Genotype|
11115698|NCT01676298|EG007|Reported Event|*2/*17 CYP2C19 Genotype|
11115699|NCT01676311|BG000|Baseline|Huperzine A|"Huperzine A will be administered to patients, titrating dose up from 100mcg/day to 600mcg per day over the course of 20 days - and remaining on the dose of 600mcg/day for the remainder of the drug phase (64 days) - for a total of 12 weeks on Huperzine A.~Huperzine A: Huperzine A will be administered for 12 weeks as outlined in the Arm Description"
11115700|NCT01676311|BG001|Baseline|Placebo|"Placebo will be administered to patients at the same frequency/intervals as the experimental arm (Huperzine-A).~Placebo: Placebo Arm (blinded randomization) for Huperzine A Intervention"
11115701|NCT01676311|BG002|Baseline|Total|Total of all reporting groups
11115702|NCT01676311|FG000|Participant Flow|Huperzine A|"Huperzine A will be administered to patients, titrating dose up from 100mcg/day to 600mcg per day over the course of 20 days - and remaining on the dose of 600mcg/day for the remainder of the drug phase (64 days) - for a total of 12 weeks on Huperzine A.~Huperzine A: Huperzine A will be administered for 12 weeks as outlined in the Arm Description"
11115703|NCT01676311|FG001|Participant Flow|Placebo|"Placebo will be administered to patients at the same frequency/intervals as the experimental arm (Huperzine-A).~Placebo: Placebo Arm (blinded randomization) for Huperzine A Intervention"
11115704|NCT01676311|OG000|Outcome|Huperzine A|"Huperzine A will be administered to patients, titrating dose up from 100mcg/day to 600mcg per day over the course of 20 days - and remaining on the dose of 600mcg/day for the remainder of the drug phase (64 days) - for a total of 12 weeks on Huperzine A.~Huperzine A: Huperzine A will be administered for 12 weeks as outlined in the Arm Description"
11115705|NCT01676311|OG001|Outcome|Placebo|"Placebo will be administered to patients at the same frequency/intervals as the experimental arm (Huperzine-A).~Placebo: Placebo Arm (blinded randomization) for Huperzine A Intervention"
11115706|NCT01676311|EG000|Reported Event|Huperzine A|"Huperzine A will be administered to patients, titrating dose up from 100mcg/day to 600mcg per day over the course of 20 days - and remaining on the dose of 600mcg/day for the remainder of the drug phase (64 days) - for a total of 12 weeks on Huperzine A.~Huperzine A: Huperzine A will be administered for 12 weeks as outlined in the Arm Description"
11115707|NCT01676311|EG001|Reported Event|Placebo|"Placebo will be administered to patients at the same frequency/intervals as the experimental arm (Huperzine-A).~Placebo: Placebo Arm (blinded randomization) for Huperzine A Intervention"
11115708|NCT01676415|BG000|Baseline|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
11115709|NCT01676415|BG001|Baseline|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
11115710|NCT01676415|BG002|Baseline|Total|Total of all reporting groups
11115711|NCT01676415|FG000|Participant Flow|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
11115712|NCT01676415|FG001|Participant Flow|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
11115713|NCT01676415|OG000|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
11115714|NCT01676415|OG001|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
11115715|NCT01676415|EG000|Reported Event|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
11115716|NCT01676415|EG001|Reported Event|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
11115717|NCT01676532|BG000|Baseline|Students Attending SBHC|"Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.~Students attending SBHC: School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC"
11115718|NCT01676532|FG000|Participant Flow|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
11115719|NCT01676532|OG000|Outcome|Students Attending SBHC|Students who were enrolled at the SBHC and then attended the SBHC
11115720|NCT01676532|OG000|Outcome|Number of Students Attending SBHC With New Treatment Plans|The total number of students who attended SBHC that had new treatment plans proposed
11115721|NCT01676532|OG000|Outcome|Number of Students Attending SBHC With New Diagnoses|Porportion of students attending SBHC with new diagnoses
11115722|NCT01676532|OG000|Outcome|Number of Referrals Made for Students Attending SBHC|Types and number of referrals made for students attending SBHC.
11115723|NCT01676532|OG000|Outcome|Number of Students From Sprucecourt Who Enrolled in SBHC|From the total number of students who enrolled in the SBHC, the number of students from the host school (Sprucecourt) was calculated
11115724|NCT01676532|OG000|Outcome|Sprucecourt Public School Vs Other Participating Schools|The number of students from the host school of the SBHC and other participating schools
11348345|NCT04179838|FG000|Participant Flow|Sleep-Deprived First, Then Non-Sleep Deprived|Participants will first be tested after 1 night with partial sleep deprivation (sleep-deprived, 4 h sleep). After a washout period of 4 weeks, they will be tested again after 1 night with normal sleep (non-sleep deprived, 8 h sleep).
11115725|NCT01676532|EG000|Reported Event|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
11348346|NCT04179838|FG001|Participant Flow|Non-Sleep Deprived First, Then Sleep-deprived|Participants will first be tested after 1 night with normal sleep (non-sleep deprived, 8 h sleep). After a washout period of 4 weeks, they will be tested again after 1 night with partial sleep deprivation (sleep-deprived, 4 h sleep).
11115726|NCT01676714|BG000|Baseline|Dovitinib|"500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.~Dovitinib"
11115727|NCT01676714|FG000|Participant Flow|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
11115728|NCT01676714|OG000|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
11115729|NCT01676714|OG000|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
11115730|NCT01676714|EG000|Reported Event|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
11115731|NCT01676727|BG000|Baseline|All Enrolled|All subjects enrolled in the trial
11115732|NCT01676727|FG000|Participant Flow|All Enrolled|All subjects enrolled in the trial
11115733|NCT01676727|OG000|Outcome|Implanted Population|All subjects who were implanted with the CoreValve.
11115734|NCT01676727|OG000|Outcome|Implanted Population|All subjects who were implanted with the CoreValve
11115735|NCT01676727|EG000|Reported Event|Implanted Population|all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach
11115736|NCT01676831|BG000|Baseline|Topical Resiquimod 0.06%|"Topical resiquimod 0.06% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will be 3 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.~Topical resiquimod 0.06%: topical resiquimod 0.06% dosing frequency begins at 3 times per week and evaluated every two weeks. Will be applied for a total of 8 weeks followed by 4 weeks rest and then followed by another 8 weeks of application with another 4 weeks rest."
11115737|NCT01676831|BG001|Baseline|Topical Resiquimod 0.03%|"Topical resiquimod 0.03% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will begin 5 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.~topical resiquimod 0.03%: topical resiquimod 0.03% applied initially 5 times weekly for 8 weeks with adjustments up or down based upon tolerability followed by 4 weeks rest followed by another 8 weeks of treatment followed by another 4 week rest period."
11115738|NCT01676831|BG002|Baseline|Total|Total of all reporting groups
11115739|NCT01676831|FG000|Participant Flow|Topical Resiquimod 0.06%|"Topical resiquimod 0.06% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will be 3 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.~Topical resiquimod 0.06%: topical resiquimod 0.06% dosing frequency begins at 3 times per week and evaluated every two weeks. Will be applied for a total of 8 weeks followed by 4 weeks rest and then followed by another 8 weeks of application with another 4 weeks rest."
11115740|NCT01676831|FG001|Participant Flow|Topical Resiquimod 0.03%|"Topical resiquimod 0.03% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will begin 5 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.~topical resiquimod 0.03%: topical resiquimod 0.03% applied initially 5 times weekly for 8 weeks with adjustments up or down based upon tolerability followed by 4 weeks rest followed by another 8 weeks of treatment followed by another 4 week rest period."
11115741|NCT01676831|OG000|Outcome|Topical Resiquimod 0.06%|"Topical resiquimod 0.06% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will be 3 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.~Topical resiquimod 0.06%: topical resiquimod 0.06% dosing frequency begins at 3 times per week and evaluated every two weeks. Will be applied for a total of 8 weeks followed by 4 weeks rest and then followed by another 8 weeks of application with another 4 weeks rest."
11115742|NCT01676831|OG001|Outcome|Topical Resiquimod 0.03%|"Topical resiquimod 0.03% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will begin 5 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.~topical resiquimod 0.03%: topical resiquimod 0.03% applied initially 5 times weekly for 8 weeks with adjustments up or down based upon tolerability followed by 4 weeks rest followed by another 8 weeks of treatment followed by another 4 week rest period."
11348347|NCT04179838|OG000|Outcome|Sleep-Deprived|Participants who were sleep-deprived in either the first or the second phase of the study.
11348348|NCT04179838|OG001|Outcome|Non-Sleep Deprived|Participants who were non-sleep deprived in either the first or the second phase of the study.
11348349|NCT04179838|EG000|Reported Event|Sleep-Deprived|Participants who were sleep-deprived in either the first or the second phase of the study.
11348350|NCT04179838|EG001|Reported Event|Non-Sleep Deprived|Participants who were non-sleep deprived in either the first or the second phase of the study.
11005508|NCT01080794|FG003|Participant Flow|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005509|NCT01080794|OG000|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005510|NCT01080794|OG001|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005511|NCT01080794|OG002|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005512|NCT01080794|OG003|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005513|NCT01080794|EG000|Reported Event|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005514|NCT01080794|EG001|Reported Event|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11115743|NCT01676831|EG000|Reported Event|Topical Resiquimod 0.06%|"Topical resiquimod 0.06% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will be 3 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.~Topical resiquimod 0.06%: topical resiquimod 0.06% dosing frequency begins at 3 times per week and evaluated every two weeks. Will be applied for a total of 8 weeks followed by 4 weeks rest and then followed by another 8 weeks of application with another 4 weeks rest."
11115744|NCT01676831|EG001|Reported Event|Topical Resiquimod 0.03%|"Topical resiquimod 0.03% will be applied in dosing frequencies that are periodically adjusted to tolerability. Dosing frequency will begin 5 times a week. The dosing frequency may be adjusted (1,2,3,5,or 7times per week) based on the physician assessment of tolerability. Treatment will occur for 8 weeks followed by 4 weeks rest followed by another 8 weeks of treatment with 4 weeks rest. At 24 weeks a final evaluation will be performed. Those with a partial response at week 24 will have the option to continue therapy for up to another 12 weeks.~topical resiquimod 0.03%: topical resiquimod 0.03% applied initially 5 times weekly for 8 weeks with adjustments up or down based upon tolerability followed by 4 weeks rest followed by another 8 weeks of treatment followed by another 4 week rest period.~13 patients were consented and enrolled. 1 patient dropped out of the clinical study this patient was in the 0.03% arm of the study. As such 5 patients were measured for adverse events"
11115745|NCT01676896|BG000|Baseline|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
11115746|NCT01676896|BG001|Baseline|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
11115747|NCT01676896|BG002|Baseline|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
11115748|NCT01676896|BG003|Baseline|Total|Total of all reporting groups
11115749|NCT01676896|FG000|Participant Flow|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
11115750|NCT01676896|FG001|Participant Flow|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
11115751|NCT01676896|FG002|Participant Flow|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
11115752|NCT01676896|OG000|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
10846070|NCT00272844|EG000|Reported Event|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
11115753|NCT01676896|OG001|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
11115754|NCT01676896|OG002|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
11115755|NCT01676896|EG000|Reported Event|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
11115756|NCT01676896|EG001|Reported Event|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
11115757|NCT01676896|EG002|Reported Event|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
11115758|NCT01676909|BG000|Baseline|Living Well|Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
11115759|NCT01676909|BG001|Baseline|Medical Illness Education and Support Group|The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
11115760|NCT01676909|BG002|Baseline|Total|Total of all reporting groups
11115761|NCT01676909|FG000|Participant Flow|Living Well|Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
11115762|NCT01676909|FG001|Participant Flow|Medical Illness Education and Support Group|The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
11115763|NCT01676909|OG000|Outcome|Living Well|Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
11115764|NCT01676909|OG001|Outcome|Medical Illness Education and Support Group|The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
11115765|NCT01676909|OG000|Outcome|Living Well|Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months..
11115766|NCT01676909|OG000|Outcome|Living Well|Living Well (LW) will be implemented as a 12-session, peer-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
11115767|NCT01676909|EG000|Reported Event|Living Well|Living Well (LW) will be implemented as a 12-session, peer-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
11115768|NCT01676909|EG001|Reported Event|Medical Illness Education and Support Group|The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
11115769|NCT01677182|BG000|Baseline|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
11115770|NCT01677182|BG001|Baseline|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
11115771|NCT01677182|BG002|Baseline|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
11115772|NCT01677182|BG003|Baseline|Total|Total of all reporting groups
11115773|NCT01677182|FG000|Participant Flow|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
11115774|NCT01677182|FG001|Participant Flow|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
11115775|NCT01677182|FG002|Participant Flow|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
10878683|NCT00453973|OG001|Outcome|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
11115776|NCT01677182|OG000|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
11115777|NCT01677182|OG001|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
11115778|NCT01677182|OG002|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
11115779|NCT01677182|EG000|Reported Event|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
11115780|NCT01677182|EG001|Reported Event|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
11115781|NCT01677182|EG002|Reported Event|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
11115782|NCT01677195|BG000|Baseline|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
11115783|NCT01677195|BG001|Baseline|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
11115784|NCT01677195|BG002|Baseline|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
11115785|NCT01677195|BG003|Baseline|Total|Total of all reporting groups
11115786|NCT01677195|FG000|Participant Flow|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
11115787|NCT01677195|FG001|Participant Flow|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
11115788|NCT01677195|FG002|Participant Flow|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
11115789|NCT01677195|OG000|Outcome|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
11115790|NCT01677195|OG001|Outcome|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
11115791|NCT01677195|OG002|Outcome|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
11115792|NCT01677195|EG000|Reported Event|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
11115793|NCT01677195|EG001|Reported Event|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
11115794|NCT01677195|EG002|Reported Event|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
11115795|NCT01677286|BG000|Baseline|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
11115796|NCT01677286|FG000|Participant Flow|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
11115797|NCT01677286|OG000|Outcome|Cardiomyopathy|Patients with predominant amyloid involvement of the heart.
11115798|NCT01677286|OG000|Outcome|Amyloid Nephropathy|Patients with predominant amyloid kidney involvement at enrollment.
11115799|NCT01677286|OG000|Outcome|Amyloid Nephropathy: Proteinuria (g/Day)|Patients with predominant amyloid kidney involvement at enrollment.
11115800|NCT01677286|EG000|Reported Event|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth was administered to subjects for 12 months, if tolerated.
11115801|NCT01677299|BG000|Baseline|Sequence BCAD|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
11115802|NCT01677299|BG001|Baseline|Sequence ABDC|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
11115803|NCT01677299|BG002|Baseline|Sequence CDBA|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
11115804|NCT01677299|BG003|Baseline|Sequence DACB|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
11115805|NCT01677299|BG004|Baseline|Total|Total of all reporting groups
11115806|NCT01677299|FG000|Participant Flow|Sequence 1: BCAD|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
11115807|NCT01677299|FG001|Participant Flow|Sequence 2: ABDC|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
11115808|NCT01677299|FG002|Participant Flow|Sequence 3: CDBA|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
11115809|NCT01677299|FG003|Participant Flow|Sequence 4: DACB|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
11115810|NCT01677299|OG000|Outcome|1000 mg EFB0026|BID
11115811|NCT01677299|OG001|Outcome|1000 mg EFB0027|BID
11115812|NCT01677299|OG002|Outcome|500 mg EFB0027|BID
11115813|NCT01677299|OG003|Outcome|500 mg EFB0026 + 1000 mg EFB0027|BID
11115814|NCT01677299|OG000|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
11115815|NCT01677299|OG001|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
11115816|NCT01677299|OG002|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
11115817|NCT01677299|OG003|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
11115818|NCT01677299|EG000|Reported Event|1000 mg EFB0026 BID|A: Metformin immediate release BID
11115819|NCT01677299|EG001|Reported Event|1000 mg EFB0027 BID|B: Metformin delayed release BID
11115820|NCT01677299|EG002|Reported Event|500 mg EFB0027 BID|C: Metformin delayed release BID
11115821|NCT01677299|EG003|Reported Event|500 mg EFB0026 BID Plus 1000 mg EFB0027 BID|D: Metformin immediate plus Metformin delayed release
11115822|NCT01677312|BG000|Baseline|19G FNA Needle|"Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.~Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.~Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed."
11115823|NCT01677312|BG001|Baseline|25G FNA Needle|"Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.~Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.~Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed."
11115824|NCT01677312|BG002|Baseline|Total|Total of all reporting groups
11115825|NCT01677312|FG000|Participant Flow|19G FNA Needle|19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
11115826|NCT01677312|FG001|Participant Flow|25G FNA Needle|25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
11115827|NCT01677312|OG000|Outcome|19G FNA Needle|19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
11115828|NCT01677312|OG001|Outcome|25G FNA Needle|25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
11115829|NCT01677312|EG000|Reported Event|19G FNA Needle|19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
11115830|NCT01677312|EG001|Reported Event|25G FNA Needle|25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
11115831|NCT01677377|BG000|Baseline|Cohort 1, RBP-7000 60 mg|Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
11115832|NCT01677377|BG001|Baseline|Cohort 2, RBP-7000 90 mg|Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
11115833|NCT01677377|BG002|Baseline|Cohort 3, RBP-7000 120 mg|Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
11115834|NCT01677377|BG003|Baseline|Total|Total of all reporting groups
11115835|NCT01677377|FG000|Participant Flow|Cohort 1, RBP-7000 60 mg|Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
11115836|NCT01677377|FG001|Participant Flow|Cohort 2, RBP-7000 90 mg|Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
11115837|NCT01677377|FG002|Participant Flow|Cohort 3, RBP-7000 120 mg|Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
11115838|NCT01677377|OG000|Outcome|Cohort 1, RBP-7000 60 mg|Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
11115839|NCT01677377|OG001|Outcome|Cohort 2, RBP-7000 90 mg|Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
11115840|NCT01677377|OG002|Outcome|Cohort 3, RBP-7000 120 mg|Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
11115841|NCT01677377|EG000|Reported Event|Cohort 1, RBP-7000 60 mg|Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
11115842|NCT01677377|EG001|Reported Event|Cohort 2, RBP-7000 90 mg|Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
11115843|NCT01677377|EG002|Reported Event|Cohort 3, RBP-7000 120 mg|Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
11115844|NCT01677507|BG000|Baseline|Baseline of Entire Population|Both arms are included because the study design was a cross over intent to treat with glaucoma medications. All participants were treated with both medications.
11115845|NCT01677507|FG000|Participant Flow|Timolol Followed by Latanoprost|"To compare the variation in response to timolol between individuals~Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to timolol 0.5%, then washout.~Period 2 is to test for variation in eye pressure response to latanoprost 0.005%."
11115846|NCT01677507|FG001|Participant Flow|Latanoprost Followed by Timolol|"To compare the variation in response to latanoprost between individuals~Variation in eye pressure response to timolol and latanoprost treatment:~Arm 1 initial period is to test for variation in eye pressure response to latanoprost 0.005%, then washout.~Period 2 is to test for variation in eye pressure response to timolol 0.5%."
11115847|NCT01677507|OG000|Outcome|Timolol|To characterize the response to timolol in all participants.
11115848|NCT01677507|OG001|Outcome|Latanoprost|To characterize the response to latanoprost in all participants.
11115849|NCT01677507|OG000|Outcome|Timolol|All participants while on timolol and during a post-timolol washout
11115850|NCT01677507|OG001|Outcome|Latanoprost|All participants while on latanoprost and during a post-latanoprost washout
11115851|NCT01677507|EG000|Reported Event|Timolol|All participants while on timolol and during a post-timolol washout
11115852|NCT01677507|EG001|Reported Event|Latanoprost|All participants while on latanoprost and during a post-latanoprost washout
11115853|NCT01677624|BG000|Baseline|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
11115854|NCT01677624|FG000|Participant Flow|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
11115855|NCT01677624|OG000|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
11115856|NCT01677624|EG000|Reported Event|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
11115857|NCT01677741|BG000|Baseline|Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115858|NCT01677741|BG001|Baseline|Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115859|NCT01677741|BG002|Baseline|Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115860|NCT01677741|BG003|Baseline|Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115861|NCT01677741|BG004|Baseline|Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)|Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115862|NCT01677741|BG005|Baseline|Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)|Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115863|NCT01677741|BG006|Baseline|Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)|Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115864|NCT01677741|BG007|Baseline|Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)|Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115865|NCT01677741|BG008|Baseline|Total|Total of all reporting groups
11115866|NCT01677741|FG000|Participant Flow|Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115867|NCT01677741|FG001|Participant Flow|Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115868|NCT01677741|FG002|Participant Flow|Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115869|NCT01677741|FG003|Participant Flow|Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115870|NCT01677741|FG004|Participant Flow|Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)|Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115871|NCT01677741|FG005|Participant Flow|Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)|Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115872|NCT01677741|FG006|Participant Flow|Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)|Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115873|NCT01677741|FG007|Participant Flow|Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)|Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115874|NCT01677741|OG000|Outcome|Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115875|NCT01677741|OG001|Outcome|Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115876|NCT01677741|OG002|Outcome|Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115877|NCT01677741|OG003|Outcome|Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11126764|NCT01735214|BG000|Baseline|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
10878684|NCT00453973|EG000|Reported Event|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
11115878|NCT01677741|OG004|Outcome|Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg|All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
11115879|NCT01677741|OG005|Outcome|Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg|All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.
11115880|NCT01677741|OG000|Outcome|Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)|Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115881|NCT01677741|OG001|Outcome|Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)|Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115882|NCT01677741|OG002|Outcome|Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)|Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115883|NCT01677741|OG003|Outcome|Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)|Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115884|NCT01677741|OG000|Outcome|Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115885|NCT01677741|OG001|Outcome|Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115886|NCT01677741|OG002|Outcome|Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115887|NCT01677741|OG003|Outcome|Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)|Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115888|NCT01677741|OG004|Outcome|All LGG Subjects at Recommended Phase 2 Dose (RP2D)|All LGG patients who have been assigned to Recommended Phase II Dose (RP2D) across Part 1 and Part 2.
11115889|NCT01677741|OG005|Outcome|All LGG Subjects|All LGG subjects in the study
11115890|NCT01677741|OG002|Outcome|Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)|Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115891|NCT01677741|OG003|Outcome|All HGG Subjects at Recommended Phase 2 Dose (RP2D)|All HGG patients who have been assigned to Recommended Phase II Dose (RP2D) across Part 1 and Part 2.
11115892|NCT01677741|OG004|Outcome|All HGG Subjects|All HGG subjects in the study
11115893|NCT01677741|OG000|Outcome|Part 1 and Part 2 - All Participants With PK Data|Participants in the study (all doses and all tumor types) with available pharmacokinetic data
11115894|NCT01677741|OG004|Outcome|Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)|Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115895|NCT01677741|OG005|Outcome|Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)|Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115896|NCT01677741|OG006|Outcome|Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)|Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115897|NCT01677741|OG007|Outcome|Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)|Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115898|NCT01677741|EG000|Reported Event|Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115899|NCT01677741|EG001|Reported Event|Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115900|NCT01677741|EG002|Reported Event|Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115901|NCT01677741|EG003|Reported Event|Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)|Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.
11115902|NCT01677741|EG004|Reported Event|Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)|Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115903|NCT01677741|EG005|Reported Event|Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)|Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115904|NCT01677741|EG006|Reported Event|Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)|Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115905|NCT01677741|EG007|Reported Event|Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)|Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
11115906|NCT01677767|BG000|Baseline|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
11115907|NCT01677767|FG000|Participant Flow|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
11115908|NCT01677767|OG000|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
11115909|NCT01677767|OG000|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
11115910|NCT01677767|OG000|Outcome|C.E.R.A.|Participants with chronic renal anemia who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.
11115911|NCT01677767|EG000|Reported Event|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
11115912|NCT01677858|BG000|Baseline|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115913|NCT01677858|BG001|Baseline|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115914|NCT01677858|BG002|Baseline|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115915|NCT01677858|BG003|Baseline|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115916|NCT01677858|BG004|Baseline|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115917|NCT01677858|BG005|Baseline|Total|Total of all reporting groups
11115918|NCT01677858|FG000|Participant Flow|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115919|NCT01677858|FG001|Participant Flow|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115920|NCT01677858|FG002|Participant Flow|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115921|NCT01677858|FG003|Participant Flow|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115922|NCT01677858|FG004|Participant Flow|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115923|NCT01677858|OG000|Outcome|Phase 1 Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115924|NCT01677858|OG001|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115925|NCT01677858|OG002|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115926|NCT01677858|OG003|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115927|NCT01677858|OG000|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115928|NCT01677858|OG004|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115929|NCT01677858|OG005|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115930|NCT01677858|OG000|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
11115931|NCT01677858|OG001|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
11115932|NCT01677858|OG002|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
11115933|NCT01677858|EG000|Reported Event|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115934|NCT01677858|EG001|Reported Event|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115935|NCT01677858|EG002|Reported Event|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115936|NCT01677858|EG003|Reported Event|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115937|NCT01677858|EG004|Reported Event|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
11115938|NCT01677910|BG000|Baseline|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115939|NCT01677910|BG001|Baseline|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115940|NCT01677910|BG002|Baseline|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115941|NCT01677910|BG003|Baseline|Total|Total of all reporting groups
11115942|NCT01677910|FG000|Participant Flow|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115943|NCT01677910|FG001|Participant Flow|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115944|NCT01677910|FG002|Participant Flow|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115945|NCT01677910|FG003|Participant Flow|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
11115946|NCT01677910|OG000|Outcome|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115947|NCT01677910|OG001|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115948|NCT01677910|OG002|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
11115949|NCT01677910|OG000|Outcome|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
10846071|NCT00272961|BG000|Baseline|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
10846072|NCT00272961|BG001|Baseline|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
11115950|NCT01677910|EG000|Reported Event|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period.
11115951|NCT01677910|EG001|Reported Event|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period.
11115952|NCT01677910|EG002|Reported Event|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the double-blind treatment period.
11115953|NCT01677910|EG003|Reported Event|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
11115954|NCT01677936|BG000|Baseline|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
11115955|NCT01677936|BG001|Baseline|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
11115956|NCT01677936|BG002|Baseline|Total|Total of all reporting groups
11115957|NCT01677936|FG000|Participant Flow|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
11115958|NCT01677936|FG001|Participant Flow|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
10846073|NCT00272961|BG002|Baseline|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
11115959|NCT01677936|OG000|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
11115960|NCT01677936|OG001|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
11115961|NCT01677936|EG000|Reported Event|Raisin|Raisin group
11115962|NCT01677936|EG001|Reported Event|Snacks|Snack group
11115963|NCT01677988|BG000|Baseline|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
11115964|NCT01677988|FG000|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
11115965|NCT01677988|OG000|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
11115966|NCT01677988|OG000|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
11115967|NCT01677988|EG000|Reported Event|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
11115968|NCT01678131|BG000|Baseline|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
11115969|NCT01678131|BG001|Baseline|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115970|NCT01678131|BG002|Baseline|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115971|NCT01678131|BG003|Baseline|Total|Total of all reporting groups
11115972|NCT01678131|FG000|Participant Flow|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
11115973|NCT01678131|FG001|Participant Flow|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115974|NCT01678131|FG002|Participant Flow|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115975|NCT01678131|OG000|Outcome|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115976|NCT01678131|OG001|Outcome|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115977|NCT01678131|OG002|Outcome|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115978|NCT01678131|EG000|Reported Event|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
11115979|NCT01678131|EG001|Reported Event|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115980|NCT01678131|EG002|Reported Event|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
11115981|NCT01678144|BG000|Baseline|Medtentia Annuloplasty Ring (MAR)|"Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)~Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)"
11115982|NCT01678144|FG000|Participant Flow|Medtentia Annuloplasty Ring (MAR)|All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR).
11115983|NCT01678144|OG000|Outcome|Medtentia Annuloplasty Ring (MAR)|Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
11115984|NCT01678144|EG000|Reported Event|Medtentia Annuloplasty Ring (MAR)|Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
11115985|NCT01678196|BG000|Baseline|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
11115986|NCT01678196|BG001|Baseline|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
11348788|NCT04147611|BG000|Baseline|Remote Microphone (RM) Technology Group|"The RM technology group will limited to the pediatrics participants.~Participants will be tested separately on the three following conditions:~Bone Conduction Device (BAHA) only~BAHA + Wireless Audio-Streaming Accessory~BAHA + Digital Adaptive RM System~BAHA: Participant's pediatric bone conduction hearing device.~Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.~Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid."
11115987|NCT01678196|BG002|Baseline|Total|Total of all reporting groups
11115988|NCT01678196|FG000|Participant Flow|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
11115989|NCT01678196|FG001|Participant Flow|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
11115990|NCT01678196|OG000|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
11115991|NCT01678196|OG001|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
11115992|NCT01678196|EG000|Reported Event|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
11115993|NCT01678196|EG001|Reported Event|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
11115994|NCT01678209|BG000|Baseline|Control Group fMRI Scans Only|Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
11115995|NCT01678209|BG001|Baseline|Atomoxetine Arm|These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
11115996|NCT01678209|BG002|Baseline|Methylphenidate Arm|Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
11115997|NCT01678209|BG003|Baseline|Total|Total of all reporting groups
11115998|NCT01678209|FG000|Participant Flow|Control Group fMRI Scans Only|Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
11115999|NCT01678209|FG001|Participant Flow|Atomoxetine Arm|These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
11116000|NCT01678209|FG002|Participant Flow|Methylphenidate Arm|Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
11116001|NCT01678209|OG000|Outcome|Control Group fMRI Scans Only|Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
11116002|NCT01678209|OG001|Outcome|Atomoxetine Arm|These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
11116003|NCT01678209|OG002|Outcome|Methylphenidate Arm|Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
11116004|NCT01678209|EG000|Reported Event|fMRI Scans|Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
11116005|NCT01678209|EG001|Reported Event|Atomoxetine Arm|These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
11116006|NCT01678209|EG002|Reported Event|Methylphenidate Arm|Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
11116007|NCT01678313|BG000|Baseline|Study Group|Doxazosin 4 mg daily plus celecoxib 200 mg daily, complete 3 month therapy N=64(91.4%)
11116008|NCT01678313|BG001|Baseline|Control Group|Doxazosin 4 mg alone everyday, complete 3 month therapy N=58(82.9%)
11116009|NCT01678313|BG002|Baseline|Total|Total of all reporting groups
11116010|NCT01678313|FG000|Participant Flow|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
11116011|NCT01678313|FG001|Participant Flow|Control Group|Doxazosin 4 mg every day (QD)
11116012|NCT01678313|OG000|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
11116013|NCT01678313|OG001|Outcome|Control Group|Doxazosin 4 mg every day (QD)
11116014|NCT01678313|EG000|Reported Event|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
11116015|NCT01678313|EG001|Reported Event|Control Group|Doxazosin 4 mg every day (QD)
11116016|NCT01678443|BG000|Baseline|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
11116017|NCT01678443|FG000|Participant Flow|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
11116018|NCT01678443|OG000|Outcome|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
11116019|NCT01678443|EG000|Reported Event|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
11116020|NCT01678560|BG000|Baseline|Usual Care|"These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.~Monitoring every 3 months by face-to-face visits"
11116021|NCT01678560|BG001|Baseline|Wireless Care|"These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.~Frequent remote monitoring"
11116022|NCT01678560|BG002|Baseline|Total|Total of all reporting groups
11116023|NCT01678560|FG000|Participant Flow|Usual Care|"These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.~Monitoring every 3 months by face-to-face visits"
11116024|NCT01678560|FG001|Participant Flow|Wireless Care|"These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.~Frequent remote monitoring"
11116025|NCT01678560|OG000|Outcome|Usual Care|"These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.~Monitoring every 3 months by face-to-face visits"
11116026|NCT01678560|OG001|Outcome|Wireless Care|"These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.~Frequent remote monitoring"
11116027|NCT01678560|OG000|Outcome|Initially Adherent Subjects|Subjects who became Adherent to the PAP treatment according to the CMS criteria within the first 3 months of treatment
11116028|NCT01678560|OG001|Outcome|Initially Non-Adherent Subjects|Subjects who remained Non-Adherent to the PAP treatment according to the CMS criteria within the first 3 months of treatment
11116029|NCT01678560|OG000|Outcome|AHI More Than 20|subjects who had more than 20 respiratory events per hour during the initial sleep study
11116030|NCT01678560|OG001|Outcome|AHI Less Than 20|subjects who had less than 20 respiratory events per hour during the initial sleep study
11116031|NCT01678560|EG000|Reported Event|Usual Care|"These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.~Monitoring every 3 months by face-to-face visits"
11116032|NCT01678560|EG001|Reported Event|Wireless Care|"These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.~Frequent remote monitoring"
11116033|NCT01678794|BG000|Baseline|Candesartan|Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
11116034|NCT01678794|BG001|Baseline|Placebo|Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
11116035|NCT01678794|BG002|Baseline|Total|Total of all reporting groups
11116036|NCT01678794|FG000|Participant Flow|Candesartan|Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
11116037|NCT01678794|FG001|Participant Flow|Placebo|Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
11116038|NCT01678794|OG000|Outcome|Candesartan|Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
11116039|NCT01678794|OG001|Outcome|Placebo|Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
11116040|NCT01678794|EG000|Reported Event|Candesartan|Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
11116041|NCT01678794|EG001|Reported Event|Placebo|Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
11116042|NCT01678807|BG000|Baseline|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
11116043|NCT01678807|BG001|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
11116044|NCT01678807|BG002|Baseline|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
11116045|NCT01678807|BG003|Baseline|Total|Total of all reporting groups
11116046|NCT01678807|FG000|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
11116047|NCT01678807|FG001|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
11116048|NCT01678807|FG002|Participant Flow|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
11116049|NCT01678807|OG000|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
11116050|NCT01678807|OG001|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
11116051|NCT01678807|OG002|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
11116052|NCT01678807|EG000|Reported Event|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
11116053|NCT01678807|EG001|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
11116054|NCT01678807|EG002|Reported Event|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
11116055|NCT01678820|BG000|Baseline|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116056|NCT01678820|BG001|Baseline|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116057|NCT01678820|BG002|Baseline|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116058|NCT01678820|BG003|Baseline|Total|Total of all reporting groups
11116059|NCT01678820|FG000|Participant Flow|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116060|NCT01678820|FG001|Participant Flow|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116061|NCT01678820|FG002|Participant Flow|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116062|NCT01678820|OG000|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116063|NCT01678820|OG001|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116064|NCT01678820|OG002|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116065|NCT01678820|OG001|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116066|NCT01678820|EG000|Reported Event|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116067|NCT01678820|EG001|Reported Event|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116068|NCT01678820|EG002|Reported Event|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
11116069|NCT01678846|BG000|Baseline|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
11116070|NCT01678846|BG001|Baseline|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
11116071|NCT01678846|BG002|Baseline|Total|Total of all reporting groups
11116072|NCT01678846|FG000|Participant Flow|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
11116073|NCT01678846|FG001|Participant Flow|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
11116074|NCT01678846|OG000|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
11116075|NCT01678846|OG001|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
11126765|NCT01735214|FG000|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
11116076|NCT01678846|EG000|Reported Event|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
11116077|NCT01678846|EG001|Reported Event|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
11116078|NCT01678885|BG000|Baseline|Sub-study 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
11116079|NCT01678885|BG001|Baseline|Sub-study 2|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
11116080|NCT01678885|BG002|Baseline|Total|Total of all reporting groups
11116081|NCT01678885|FG000|Participant Flow|Phase I Sub-study 1 - Dig Photo First, Then IDEEA & Actical|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
11116082|NCT01678885|FG001|Participant Flow|Phase 1 Sub-study 1 - IDEEA & Actical First, Then Dig Photo|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
11116083|NCT01678885|FG002|Participant Flow|Phase 1 Sub Study 2 - Dig Photo First, Then Sensewear|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
11116084|NCT01678885|FG003|Participant Flow|Phase I Sub Study 2 - Sensewear First, Then Digital Photo|Phase 1- sensewear First, Then Digital Photography
11116085|NCT01678885|FG004|Participant Flow|Phase 2- Low-Calorie Diet|"Participants from sub-study 1 and 2 had the chance to receive the low-calorie diet based on their eligibility; i.e., BMI level.~Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected."
11116086|NCT01678885|OG000|Outcome|Phase 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
11116087|NCT01678885|OG000|Outcome|Phase II|Participants who complete Phase I of the study received a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan was a 1000-1150 kcal/day diet composed of Health One shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data was collected.
11116088|NCT01678885|OG000|Outcome|All Participants|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
11116089|NCT01678885|OG000|Outcome|All Participants|All study participants were included in these analyses
11116090|NCT01678885|EG000|Reported Event|Sub-study 1|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
11116091|NCT01678885|EG001|Reported Event|Sub-study 2|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
11116092|NCT01678898|BG000|Baseline|0.2 mg/kg|"PRX-102 0.2 mg/kg every 2 weeks~PRX-102"
11116093|NCT01678898|BG001|Baseline|1 mg/kg|"PRX-102 1 mg/kg every 2 weeks~PRX-102"
11116094|NCT01678898|BG002|Baseline|2 mg/kg|"PRX-102 2 mg/kg every 2 weeks~PRX-102"
11116095|NCT01678898|BG003|Baseline|Total|Total of all reporting groups
11116096|NCT01678898|FG000|Participant Flow|0.2 mg/kg|"PRX-102 0.2 mg/kg every 2 weeks~PRX-102"
11116097|NCT01678898|FG001|Participant Flow|1 mg/kg|"PRX-102 1 mg/kg every 2 weeks~PRX-102"
11116098|NCT01678898|FG002|Participant Flow|2 mg/kg|"PRX-102 2 mg/kg every 2 weeks~PRX-102"
11116099|NCT01678898|OG000|Outcome|Safety Group|The safety population in the study included 18 patients: 6 patients in the 0.2 mg/kg treatment group, 8 patients in the 1.0 mg/kg, and 4 patients in the 2.0 mg/kg treatment groups.
11116100|NCT01678898|OG001|Outcome|0.2 mg/kg|PRX-102 0.2 mg/kg every 2 weeks
11116101|NCT01678898|OG002|Outcome|1.0 mg/kg|PRX-102 1.0 mg/kg every 2 weeks
11116102|NCT01678898|OG003|Outcome|2.0 mg/kg|PRX-102 2.0 mg/kg every 2 weeks
11116103|NCT01678898|OG000|Outcome|0.2 mg/kg|"PRX-102 0.2 mg/kg every 2 weeks~PRX-102"
11116104|NCT01678898|OG001|Outcome|1 mg/kg|"PRX-102 1 mg/kg every 2 weeks~PRX-102"
11116105|NCT01678898|OG002|Outcome|2 mg/kg|"PRX-102 2 mg/kg every 2 weeks~PRX-102"
11116106|NCT01678898|OG003|Outcome|Efficacy Group|The efficacy group includes all the subjects that completed the study.
11116107|NCT01678898|OG004|Outcome|Phenotypically Classic Fabry Patients|Patients who are phenotypically classic Fabry Patients.
11116108|NCT01678898|OG000|Outcome|Pegunigalsidase Alfa Reporting Group|All 16 patients in the efficacy group, including both phenotypically classic Fabry patients and non classic Fabry patients.
11116109|NCT01678898|OG001|Outcome|Phenotypically Classic Fabry Patients|10 patients who are phenotypically classic Fabry patients.
11116110|NCT01678898|OG004|Outcome|Phenotypically Classic Fabry Patients|Patients who are phenotypically classic Fabry patients.
11116111|NCT01678898|EG000|Reported Event|0.2 mg/kg|PRX-102 0.2 mg/kg every 2 weeks
11116112|NCT01678898|EG001|Reported Event|1 mg/kg|PRX-102 1.0 mg/kg every 2 weeks
11116113|NCT01678898|EG002|Reported Event|2 mg/kg|PRX-102 2.0 mg/kg every 2 weeks
11116114|NCT01678911|BG000|Baseline|All Subjects|All randomized subjects
11116115|NCT01678911|FG000|Participant Flow|Placebo, Then Gralise|Subjects may receive a pill with no medicine.
11116116|NCT01678911|FG001|Participant Flow|Gralise Then Placebo|"Gralise (a long acting gabapentinoid)~Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of wash-out before repeating the above procedure for the other arm of the study (placebo or medication)."
11116117|NCT01678911|OG000|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
11116118|NCT01678911|OG001|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
11116119|NCT01678911|EG000|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
11116120|NCT01678911|EG001|Reported Event|Gralise|"Gralise (a long acting gabapentinoid)~Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of wash-out before repeating the above procedure for the other arm of the study (placebo or medication)."
11116121|NCT01678924|BG000|Baseline|AGN 214868 130µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116122|NCT01678924|BG001|Baseline|AGN 214868 65µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116123|NCT01678924|BG002|Baseline|AGN 214868 32.5µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116124|NCT01678924|BG003|Baseline|Placebo|Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
11116125|NCT01678924|BG004|Baseline|Total|Total of all reporting groups
11116126|NCT01678924|FG000|Participant Flow|AGN 214868 130µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116127|NCT01678924|FG001|Participant Flow|AGN 214868 65µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116128|NCT01678924|FG002|Participant Flow|AGN 214868 32.5µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116129|NCT01678924|FG003|Participant Flow|Placebo|Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
11116130|NCT01678924|OG000|Outcome|AGN 214868 65µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116131|NCT01678924|OG001|Outcome|AGN 214868 32.5µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116132|NCT01678924|OG002|Outcome|Placebo|Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
11116133|NCT01678924|OG000|Outcome|AGN 214868 130µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116134|NCT01678924|OG001|Outcome|Placebo|Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
11116135|NCT01678924|EG000|Reported Event|AGN 214868 130µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116136|NCT01678924|EG001|Reported Event|AGN 214868 65µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116137|NCT01678924|EG002|Reported Event|AGN 214868 32.5µg|Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
11116138|NCT01678924|EG003|Reported Event|Placebo|Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
11116139|NCT01678976|BG000|Baseline|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
11116140|NCT01678976|BG001|Baseline|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
11116141|NCT01678976|BG002|Baseline|Total|Total of all reporting groups
11116142|NCT01678976|FG000|Participant Flow|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
11116143|NCT01678976|FG001|Participant Flow|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
11116144|NCT01678976|OG000|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL Eslicarbazepine acetate
11116145|NCT01678976|OG001|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
11116146|NCT01678976|OG000|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL, Eslicarbazepine acetate
11116147|NCT01678976|OG000|Outcome|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
11116148|NCT01678976|OG001|Outcome|Oxcarbazepine|Oxcarbazepine, Trileptal
11116149|NCT01678976|EG000|Reported Event|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
11116150|NCT01678976|EG001|Reported Event|Oxcarbazepine|Oxcarbazepine, Trileptal
11116151|NCT01679002|BG000|Baseline|Group A|BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
11116152|NCT01679002|BG001|Baseline|Group B|BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 450 mg od
11116153|NCT01679002|BG002|Baseline|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 450 mg od - BIA 2-093 450 mg bid
11116154|NCT01679002|BG003|Baseline|Total|Total of all reporting groups
11116155|NCT01679002|FG000|Participant Flow|Group A|"BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.~BIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid"
11116156|NCT01679002|FG001|Participant Flow|Group B|"BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period~BIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od"
11116157|NCT01679002|FG002|Participant Flow|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
11116158|NCT01679002|OG000|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
11116159|NCT01679002|OG001|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
11116160|NCT01679002|OG002|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
11116161|NCT01679002|EG000|Reported Event|BIA 2-093 900 mg|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
11116162|NCT01679002|EG001|Reported Event|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
11116163|NCT01679002|EG002|Reported Event|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
11116164|NCT01679028|BG000|Baseline|Placebo Group A|Placebo 150mg single dose
11116165|NCT01679028|BG001|Baseline|T89 Group A|T89 150mg single dose
11116166|NCT01679028|BG002|Baseline|Placebo Group B|Placebo 300mg single dose
11116167|NCT01679028|BG003|Baseline|T89 Group B|T89 300mg single dose
11116168|NCT01679028|BG004|Baseline|Placebo Group C|Placebo 225mg bid for 14 days
11116169|NCT01679028|BG005|Baseline|T89 Group C|T89 225mg bid for 14 days
11116170|NCT01679028|BG006|Baseline|Total|Total of all reporting groups
11116171|NCT01679028|FG000|Participant Flow|Placebo Group A|Placebo 150mg single dose
11116172|NCT01679028|FG001|Participant Flow|T89 Group A|T89 150mg single dose
11116173|NCT01679028|FG002|Participant Flow|Placebo Group B|Placebo 300mg single dose
11116174|NCT01679028|FG003|Participant Flow|T89 Group B|T89 300mg single dose
11116175|NCT01679028|FG004|Participant Flow|Placebo Group C|Placebo 225mg bid for 14 days
11116176|NCT01679028|FG005|Participant Flow|T89 Group C|T89 225mg bid for 14 days
11116177|NCT01679028|OG000|Outcome|Placebo Group A|150 mg placebo; single dose
11116178|NCT01679028|OG001|Outcome|T89 Group A|150mg T89; Single dose
11116179|NCT01679028|OG002|Outcome|Placebo Group B|300mg Placebo; single dose
11116180|NCT01679028|OG003|Outcome|T89 Group B|300mg T89; single dose
11116181|NCT01679028|OG004|Outcome|Placebo Group C|225mg bid for 10 days
11116182|NCT01679028|OG005|Outcome|T89 Group C|T89 225mg bid for 10 days
11116183|NCT01679028|EG000|Reported Event|Placebo Group A|150 mg Placebo Single dose
11116184|NCT01679028|EG001|Reported Event|T89 Group A|150mg T89 single dose
11116185|NCT01679028|EG002|Reported Event|Placebo Group B|300mg Placebo single dose
11116186|NCT01679028|EG003|Reported Event|T89 Group B|300mg T89 single dose
11116187|NCT01679028|EG004|Reported Event|Placebo Group C|Placebo 225mg bid for 14 days
11116188|NCT01679028|EG005|Reported Event|T89 Group C|T89 225mf bid for 14 days
11116189|NCT01679197|BG000|Baseline|Treatment|"Metreleptin~Metreleptin"
11116190|NCT01679197|FG000|Participant Flow|Treatment|"Metreleptin~Metreleptin"
11116191|NCT01679197|OG000|Outcome|Treatment|"Metreleptin~Metreleptin"
11116192|NCT01679197|OG000|Outcome|Liver Function AST|
11116193|NCT01679197|OG001|Outcome|Liver Function ALT|
11116194|NCT01679197|OG000|Outcome|Cholesterol, Total mg/dL|Lipid measurement
11116195|NCT01679197|OG001|Outcome|Triglycerides mg/dL|Lipid measurement
11116196|NCT01679197|OG002|Outcome|HDL Cholesterol mg/dL|Lipid measurement
11116197|NCT01679197|OG003|Outcome|LDL mg/dL|Lipid measurement
11116198|NCT01679197|EG000|Reported Event|Treatment|"Metreleptin~Metreleptin"
11116199|NCT01679236|BG000|Baseline|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
11116200|NCT01679236|BG001|Baseline|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
11116201|NCT01679236|BG002|Baseline|Total|Total of all reporting groups
11116202|NCT01679236|FG000|Participant Flow|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
11126766|NCT01735214|OG000|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
11126767|NCT01735214|EG000|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
11116203|NCT01679236|FG001|Participant Flow|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
11116204|NCT01679236|OG000|Outcome|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
11116205|NCT01679236|OG001|Outcome|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
11116206|NCT01679236|EG000|Reported Event|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
11116207|NCT01679236|EG001|Reported Event|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
11116208|NCT01679301|BG000|Baseline|Participants|All Participants enrolled in the study
11116209|NCT01679301|FG000|Participant Flow|Participants|All Participants enrolled in the study
11116210|NCT01679301|FG001|Participant Flow|Continuous Dose Then Pulse Dose ('Sleep Mode')|"Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.~Continuous Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose."
11116211|NCT01679301|FG002|Participant Flow|Pulse Dose ('Sleep Mode') Then Continuous Dose|Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator Pulse Dose (Sleep Mode): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
11116212|NCT01679301|OG000|Outcome|Continuous Dose|"Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.~Continuous Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose."
11116213|NCT01679301|OG001|Outcome|Pulse Dose ('Sleep Mode')|"Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator~Pulse Dose (Sleep Mode): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose."
11116214|NCT01679301|EG000|Reported Event|Continuous Dose|"Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.~Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose"
11116215|NCT01679301|EG001|Reported Event|Pulse Dose ('Sleep Mode')|"Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator~Pulse Dose (Sleep Mode): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose."
11116216|NCT01679314|BG000|Baseline|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
11116217|NCT01679314|BG001|Baseline|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
11116218|NCT01679314|BG002|Baseline|Total|Total of all reporting groups
11116219|NCT01679314|FG000|Participant Flow|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
11116220|NCT01679314|FG001|Participant Flow|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
11116221|NCT01679314|OG000|Outcome|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
11116222|NCT01679314|OG001|Outcome|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
11116223|NCT01679314|OG000|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
11116224|NCT01679314|OG001|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
11116225|NCT01679314|OG000|Outcome|Active AlphaCore Device|"Active AlphaCore Device~Each study group will go under the same treatment regimen and assessments."
11116226|NCT01679314|OG001|Outcome|Sham AlphaCore Device|"Sham AlphaCore Device~Each study group will go under the same treatment regimen and assessments."
11116227|NCT01679314|EG000|Reported Event|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
11116228|NCT01679314|EG001|Reported Event|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
11116229|NCT01679405|BG000|Baseline|Dose Level 1|30 mg BIBW 2992, Gemcitabine (1.000 mg/m² BSA i.v.)/Cisplatin (25 mg/m² BSA i.v.)
11116230|NCT01679405|BG001|Baseline|Dose Level -1|30 mg BIBW 2992, Gemcitabine (800 mg/m² BSA i.v.)/Cisplatin (20 mg/m² BSA i.v.)
11116231|NCT01679405|BG002|Baseline|Total|Total of all reporting groups
11116232|NCT01679405|FG000|Participant Flow|Dose Level 1|30 mg BIBW 2992, Gemcitabine (1.000 mg/m² BSA i.v.)/Cisplatin (25 mg/m² BSA i.v.)
11116233|NCT01679405|FG001|Participant Flow|Dose Level -1|30 mg BIBW 2992, Gemcitabine (800 mg/m² BSA i.v.)/Cisplatin (20 mg/m² BSA i.v.)
11116234|NCT01679405|OG000|Outcome|Dose Level 1|30 mg BIBW 2992, Gemcitabine (1.000 mg/m² BSA i.v.)/Cisplatin (25 mg/m² BSA i.v.)
11116235|NCT01679405|OG001|Outcome|Dose Level -1|30 mg BIBW 2992, Gemcitabine (800 mg/m² BSA i.v.)/Cisplatin (20 mg/m² BSA i.v.)
11116236|NCT01679405|EG000|Reported Event|Dose Level 1|30 mg BIBW 2992, Gemcitabine (1.000 mg/m² BSA i.v.)/Cisplatin (25 mg/m² BSA i.v.)
11116237|NCT01679405|EG001|Reported Event|Dose Level -1|30 mg BIBW 2992, Gemcitabine (800 mg/m² BSA i.v.)/Cisplatin (20 mg/m² BSA i.v.)
11116238|NCT01679600|BG000|Baseline|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
11116239|NCT01679600|BG001|Baseline|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
11116240|NCT01679600|BG002|Baseline|Total|Total of all reporting groups
11116241|NCT01679600|FG000|Participant Flow|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
11116242|NCT01679600|FG001|Participant Flow|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
11116243|NCT01679600|OG000|Outcome|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
11116244|NCT01679600|OG001|Outcome|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
11116245|NCT01679600|EG000|Reported Event|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
11116246|NCT01679600|EG001|Reported Event|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
11116247|NCT01679613|BG000|Baseline|Overall Study|This was a randomised, open-label trial in healthy male subjects with a 2-way cross-over Pilot part, followed by a 2-way cross-over Main part. Subjects participated either in the Pilot part with 2 treatments (A and B) given in 1 of the 2 treatment sequences (A_B and B_A) or in the Main part with also 2 treatments (C and D) given in 1 of the 2 treatment sequences (C_D and D_C). Nintedanib administrations of the 2 respective treatments (A and B or C and D) were to be separated by a wash-out period of at least 14 days. The Pilot part was separated from the Main part by at least 3 weeks to allow for interim analysis
11116248|NCT01679613|FG000|Participant Flow|Nintedanib (Pilot Part)/ Nintedanib+Ketoconazole (Pilot Part)|Nintedanib 50mg was given as a single dose (Treatment A). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B)
11116249|NCT01679613|FG001|Participant Flow|Nintedanib+Ketoconazole (Pilot Part)/ Nintedanib (Pilot Part)|Ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose (Treatment A).
11116250|NCT01679613|FG002|Participant Flow|Nintedanib (Main Part)/ Nintedanib+Ketoconazole (Main Part)|Based on the results from the Pilot part, nintedanib 50mg was given as a single dose (Treatment C). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D)
11126768|NCT01735279|BG000|Baseline|Placebo|placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.
11126769|NCT01735279|BG001|Baseline|Omega3|omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
11116251|NCT01679613|FG003|Participant Flow|Nintedanib+Ketoconazole (Main Part)/ Nintedanib (Main Part)|Ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose, based on the results from the Pilot part (Treatment C).
11116252|NCT01679613|OG000|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
11116253|NCT01679613|OG001|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
11116254|NCT01679613|EG000|Reported Event|Ketoconazole|In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2
11116255|NCT01679613|EG001|Reported Event|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
11116256|NCT01679613|EG002|Reported Event|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
11116257|NCT01680016|BG000|Baseline|Zagreb|Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
11116258|NCT01680016|BG001|Baseline|Essen|Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116259|NCT01680016|BG002|Baseline|Total|Total of all reporting groups
11116260|NCT01680016|FG000|Participant Flow|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
11116261|NCT01680016|FG001|Participant Flow|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116262|NCT01680016|FG002|Participant Flow|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
11116263|NCT01680016|FG003|Participant Flow|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116264|NCT01680016|OG000|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
11116265|NCT01680016|OG001|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116266|NCT01680016|OG000|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
11116267|NCT01680016|OG001|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116268|NCT01680016|OG000|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
11116269|NCT01680016|OG001|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116270|NCT01680016|OG002|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
11116271|NCT01680016|OG003|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116272|NCT01680016|OG004|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
11116273|NCT01680016|OG005|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116274|NCT01680016|OG000|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
11116275|NCT01680016|OG001|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116276|NCT01680016|OG002|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
11116277|NCT01680016|OG003|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116278|NCT01680016|OG004|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
11116279|NCT01680016|OG005|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
11116280|NCT01680016|EG000|Reported Event|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
11116281|NCT01680016|EG001|Reported Event|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
11116282|NCT01680016|EG002|Reported Event|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
11116283|NCT01680016|EG003|Reported Event|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
11116284|NCT01680159|BG000|Baseline|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116285|NCT01680159|BG001|Baseline|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116286|NCT01680159|BG002|Baseline|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116287|NCT01680159|BG003|Baseline|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116288|NCT01680159|BG004|Baseline|Total|Total of all reporting groups
11116289|NCT01680159|FG000|Participant Flow|TA-650|"During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either efficacy attenuated or efficacy maintained at week 8 of the normal dose period)."
11116290|NCT01680159|OG000|Outcome|Overall|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116291|NCT01680159|OG001|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116292|NCT01680159|OG002|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116293|NCT01680159|OG003|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116294|NCT01680159|OG004|Outcome|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116295|NCT01680159|OG000|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116296|NCT01680159|OG000|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116297|NCT01680159|OG000|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
11116298|NCT01680159|EG000|Reported Event|TA-650（Normal Dose Period）Overall|Overall(Plaque Psoriasis・Psoriatic Arthritis)
11116299|NCT01680159|EG001|Reported Event|TA-650（Normal Dose Period）Plaque Psoriasis|Plaque Psoriasis
11116300|NCT01680159|EG002|Reported Event|TA-650（Normal Dose Period）Psoriatic Arthritis|Psoriatic Arthritis
11116301|NCT01680159|EG003|Reported Event|TA-650（Dose Escalation Period）Overall|Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma)
11116302|NCT01680159|EG004|Reported Event|TA-650（Dose Escalation Period）Plaque Psoriasis|Plaque Psoriasis
11116303|NCT01680159|EG005|Reported Event|TA-650（Dose Escalation Period）Psoriatic Arthritis|Psoriatic Arthritis
11116304|NCT01680159|EG006|Reported Event|TA-650（Dose Escalation Period）Pustular Psoriasis|Pustular Psoriasis
11116305|NCT01680159|EG007|Reported Event|TA-650（Dose Escalation Period）Psoriatic Erythroderma|Psoriatic Erythroderma
11116306|NCT01680159|EG008|Reported Event|TA-650（Entire Evaluation Period）Plaque Psoriasis|Plaque Psoriasis
11116307|NCT01680159|EG009|Reported Event|TA-650（Entire Evaluation Period）Psoriatic Arthritis|Psoriatic Arthritis
11116308|NCT01680172|BG000|Baseline|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
11116309|NCT01680172|BG001|Baseline|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
11116310|NCT01680172|BG002|Baseline|Total|Total of all reporting groups
11116311|NCT01680172|FG000|Participant Flow|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
11116312|NCT01680172|FG001|Participant Flow|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
11116313|NCT01680172|OG000|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
11116314|NCT01680172|OG001|Outcome|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
11116315|NCT01680172|EG000|Reported Event|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
11116316|NCT01680172|EG001|Reported Event|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
11116317|NCT01680328|BG000|Baseline|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
11116318|NCT01680328|FG000|Participant Flow|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
11116319|NCT01680328|OG000|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
11116320|NCT01680328|OG001|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
11116321|NCT01680328|OG002|Outcome|Injection Volume 1600 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116322|NCT01680328|OG003|Outcome|Injection Volume 1200 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116323|NCT01680328|OG004|Outcome|Injection Volume 800 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116324|NCT01680328|OG005|Outcome|Injection Volume 400 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116325|NCT01680328|OG006|Outcome|Injection Speed at 450 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116326|NCT01680328|OG007|Outcome|Injection Speed at 300 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116327|NCT01680328|OG008|Outcome|Injection Speed at 150 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116328|NCT01680328|OG000|Outcome|Injection Volume of 1600 μL|Acceptance of pain was assessed in each subject for all injections.
11116329|NCT01680328|OG001|Outcome|Injection Volume of 1200 μL|Acceptance of pain was assessed in each subject for all injections.
11116330|NCT01680328|OG002|Outcome|Injection Volume of 800 μL|Acceptance of pain was assessed in each subject for all injections.
11116331|NCT01680328|OG003|Outcome|Injection Volume of 400 μL|Acceptance of pain was assessed in each subject for all injections.
11116332|NCT01680328|OG000|Outcome|Injection Speed at 450 μL/s|Acceptance of pain was assessed in each subject for all injections.
11116333|NCT01680328|OG001|Outcome|Injection Speed at 300 μL/s|Acceptance of pain was assessed in each subject for all injections.
11116334|NCT01680328|OG002|Outcome|Injection Speed at 150 μL/s|Acceptance of pain was assessed in each subject for all injections.
11116335|NCT01680328|OG000|Outcome|Thighs|Acceptance of pain was assessed in each subject for all injections in the thighs.
11116336|NCT01680328|OG001|Outcome|Abdomen|Acceptance of pain was assessed in each subject for all injections in the abdomen.
11116337|NCT01680328|OG000|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
11116338|NCT01680328|OG001|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116339|NCT01680328|OG002|Outcome|Injection Volume 1200 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116340|NCT01680328|OG003|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11126770|NCT01735279|BG002|Baseline|Total|Total of all reporting groups
11116341|NCT01680328|OG004|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116342|NCT01680328|OG005|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116343|NCT01680328|OG006|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116344|NCT01680328|OG007|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116345|NCT01680328|OG000|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
11116346|NCT01680328|OG002|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116347|NCT01680328|OG003|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116348|NCT01680328|OG004|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116349|NCT01680328|OG005|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116350|NCT01680328|OG006|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
11116351|NCT01680328|EG000|Reported Event|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
11116352|NCT01680341|BG000|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
11116353|NCT01680341|BG001|Baseline|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
11116354|NCT01680341|BG002|Baseline|Total|Total of all reporting groups
11116355|NCT01680341|FG000|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
11126771|NCT01735279|FG000|Participant Flow|Placebo|placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses.
11126772|NCT01735279|FG001|Participant Flow|Omega3|omega 3 capsules 1,000 mg fish oil taken as 3 daily doses. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
11116356|NCT01680341|FG001|Participant Flow|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
11116357|NCT01680341|OG000|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
11116358|NCT01680341|OG001|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
11116359|NCT01680341|EG000|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
11116360|NCT01680341|EG001|Reported Event|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
11116361|NCT01680458|BG000|Baseline|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
11116362|NCT01680458|FG000|Participant Flow|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
11116363|NCT01680458|OG000|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
11116364|NCT01680458|EG000|Reported Event|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
11116365|NCT01680497|BG000|Baseline|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
11116366|NCT01680497|FG000|Participant Flow|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
11116367|NCT01680497|OG000|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
10879567|NCT00458484|FG003|Participant Flow|Series 1/Dose Level 4: Stereotactic Radiosurgery|"Dose Level 4: Radiation will be delivered in 4 fractions:~12 Gy x 4 fractions: Total of 48 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
11116368|NCT01680497|EG000|Reported Event|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
11116369|NCT01680549|BG000|Baseline|Gabapentin|"Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.~Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days."
11116370|NCT01680549|BG001|Baseline|Placebo|"Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days~Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days."
11116371|NCT01680549|BG002|Baseline|Total|Total of all reporting groups
11116372|NCT01680549|FG000|Participant Flow|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
11116373|NCT01680549|FG001|Participant Flow|Placebo|Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
11116374|NCT01680549|OG000|Outcome|Placebo|Placebo- Comparator
11116375|NCT01680549|OG001|Outcome|Gabapentin|Active pain medicine
11116376|NCT01680549|OG000|Outcome|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
11116377|NCT01680549|OG001|Outcome|Placebo|Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
11116378|NCT01680549|OG000|Outcome|Placebo|Placebo- comparator
11116379|NCT01680549|OG001|Outcome|Gabapentin|Active pain control Medicine
11116380|NCT01680549|OG000|Outcome|Placebo|Placebo comparator
11116381|NCT01680549|OG001|Outcome|Gabapentin|Active pain control medicine
11116382|NCT01680549|EG000|Reported Event|Placebo|placebo comparator
11116383|NCT01680549|EG001|Reported Event|Gabapentin|Active pain control medicine
11116384|NCT01680640|BG000|Baseline|Synbiotic|"Fructo-oligosaccharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day).~Synbiotic: The synbiotic to be used is fructo-oligosaccharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day)."
11116385|NCT01680640|BG001|Baseline|Maltodextrin|"4 grams of maltodextrin daily.~Maltodextrin"
11116386|NCT01680640|BG002|Baseline|Total|Total of all reporting groups
11116387|NCT01680640|FG000|Participant Flow|Synbiotic|"Fructo-oligosaccharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day).~Synbiotic: The synbiotic to be used is fructo-oligosachharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day)."
11116388|NCT01680640|FG001|Participant Flow|Maltodextrin|"4 grams of maltodextrin daily.~Maltodextrin"
11116389|NCT01680640|OG000|Outcome|Synbiotic|"Fructo-oligosaccharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day).~Synbiotic: The synbiotic to be used is fructo-oligosaccharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day)."
11116390|NCT01680640|OG001|Outcome|Maltodextrin|"4 grams of maltodextrin daily.~Maltodextrin"
11116391|NCT01680640|EG000|Reported Event|Synbiotic|"Fructo-oligosaccharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day).~Synbiotic: The synbiotic to be used is fructo-oligosaccharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day)."
11116392|NCT01680640|EG001|Reported Event|Maltodextrin|"4 grams of maltodextrin daily.~Maltodextrin"
11116393|NCT01680653|BG000|Baseline|All Participants|The subjects were enrolled at three camps for diabetes; from each camp approximately 20 subjects were enrolled. There were two locations, one hosting two sessions. Each camp was approximately 5-6 days in length. Campers wore a continuous glucose sensor every day they were in the study. On alternate nights they had remote monitoring, this defined the primary treatment arms: remote monitoring or no remote monitoring. On alternating days of remote monitoring hypoglycemia was treated with either mini glucagon or carbohydrates, this was a secondary randomization.
11116394|NCT01680653|FG000|Participant Flow|All Participants|The subjects participated in three camps; each camp had approximately 20 subjects. There were two locations, one hosting two sessions. Each camp was approximately 5-6 days in length. Campers wore the device on alternating days, and hypoglycemia was treated with either mini glucagon or carbohydrates.
11116395|NCT01680653|OG000|Outcome|Remote Monitoring|"Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.~Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 units glucagon.~Mini-glucagon: Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age~Remote monitoring: Provides real-time continuous glucose monitoring"
11116396|NCT01680653|OG001|Outcome|Control|"Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.~Administration of carbohydrate per camp protocol to treat nocturnal hypoglycemia. Expected treatment is 15-45g.~Remote monitoring: Provides real-time continuous glucose monitoring~Carbohydrates and remote monitoring: 16 grams of carbohydrate with remote monitoring"
11116397|NCT01680653|OG000|Outcome|Remote Monitoring|"Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.~Remote monitoring: Provides real-time continuous glucose monitoring"
11116398|NCT01680653|OG001|Outcome|Control (no Remote Monitoring)|Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.
11116399|NCT01680653|OG000|Outcome|Remote Monitoring|Subjects who were on the device during the night (remotely monitored)
11116400|NCT01680653|OG001|Outcome|Control|Subjects who were not being remotely monitored (not on the device)
11116401|NCT01680653|EG000|Reported Event|Remote Monitoring|All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.
11116402|NCT01680653|EG001|Reported Event|Control (no Remote Monitoring)|All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.
11116403|NCT01680666|BG000|Baseline|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
11116404|NCT01680666|BG001|Baseline|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
11116405|NCT01680666|BG002|Baseline|Total|Total of all reporting groups
11116406|NCT01680666|FG000|Participant Flow|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
11116407|NCT01680666|FG001|Participant Flow|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
11116408|NCT01680666|OG000|Outcome|Landmark Technique|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
11116409|NCT01680666|OG001|Outcome|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
11116410|NCT01680666|OG000|Outcome|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
11116411|NCT01680666|EG000|Reported Event|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
11116412|NCT01680666|EG001|Reported Event|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
11116413|NCT01680783|BG000|Baseline|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.~Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
11116414|NCT01680783|BG001|Baseline|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure~Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
11116415|NCT01680783|BG002|Baseline|Total|Total of all reporting groups
11116416|NCT01680783|FG000|Participant Flow|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.~Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
11116417|NCT01680783|FG001|Participant Flow|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure~Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
11116418|NCT01680783|OG000|Outcome|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.~Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
11116419|NCT01680783|OG001|Outcome|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure~Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
11116420|NCT01680783|EG000|Reported Event|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.~Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
11116421|NCT01680783|EG001|Reported Event|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure~Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
11116422|NCT01680835|BG000|Baseline|Study Cohort|All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
11116423|NCT01680835|FG000|Participant Flow|Study Cohort|All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
11116424|NCT01680835|OG000|Outcome|Study Cohort|All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
11116425|NCT01680835|EG000|Reported Event|Study Cohort|All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
11116426|NCT01680848|BG000|Baseline|JDPBRN Dentists|"Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.~The JDPBRN aims to allow dentists to investigate research questions and share experiences and expertise and recruited its members from the JDPBRN website."
11116427|NCT01680848|FG000|Participant Flow|JDPBRN Dentists|Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.
11116428|NCT01680848|OG000|Outcome|High Caries Risk|The proportion of dentists who indicated surgical intervention into enamel was 74% (N = 138) in the high-caries-risk scenario.
11116429|NCT01680848|EG000|Reported Event|This is an Observational Study|This is an observational study. We don't have two arms.
11116430|NCT01680861|BG000|Baseline|Tacrolimus/Everolimus|our experimental maintenance arm.
11116431|NCT01680861|BG001|Baseline|Tacrolimus/EC-MPS|our standard maintenance arm.
11116432|NCT01680861|BG002|Baseline|Total|Total of all reporting groups
11116433|NCT01680861|FG000|Participant Flow|Tacrolimus/Everolimus|our experimental maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target 12-hr Everolimus trough level: 3-8 ng/mL.
11116434|NCT01680861|FG001|Participant Flow|Tacrolimus/EC-MPS|our standard maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target EC-MPS dose: 720 mg PO BID (as tolerated).
11116435|NCT01680861|OG000|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
11116436|NCT01680861|OG001|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
11116437|NCT01680861|OG000|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
11116438|NCT01680861|OG001|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
11116439|NCT01680861|EG000|Reported Event|Tacrolimus/Everolimus|our experimental maintenance arm
11116440|NCT01680861|EG001|Reported Event|Tacrolimus/EC-MPS|our standard maintenance arm
11116441|NCT01680887|BG000|Baseline|Varenicline|"Oral 1.0 mg BID.~Varenicline"
11116442|NCT01680887|BG001|Baseline|Placebo|"Oral 1.0 mg BID.~Placebo"
11116443|NCT01680887|BG002|Baseline|Total|Total of all reporting groups
11116444|NCT01680887|FG000|Participant Flow|Varenicline|"Oral 1.0 mg BID.~Varenicline"
11116445|NCT01680887|FG001|Participant Flow|Placebo|"Oral 1.0 mg BID.~Placebo"
11116446|NCT01680887|OG000|Outcome|Varenicline|"Oral 1.0 mg BID.~Varenicline"
11116447|NCT01680887|OG001|Outcome|Placebo|"Oral 1.0 mg BID.~Placebo"
11116448|NCT01680887|EG000|Reported Event|Varenicline|varenicline 2 mg daily
11116449|NCT01680887|EG001|Reported Event|Placebo|Identical placebo capsules
11116450|NCT01680900|BG000|Baseline|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
11116451|NCT01680900|BG001|Baseline|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
11116452|NCT01680900|BG002|Baseline|Total|Total of all reporting groups
11126773|NCT01735279|OG000|Outcome|Placebo|placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.
11116453|NCT01680900|FG000|Participant Flow|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
11116454|NCT01680900|FG001|Participant Flow|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
11116455|NCT01680900|OG000|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
11116456|NCT01680900|OG001|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
11116457|NCT01680900|EG000|Reported Event|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
11116458|NCT01680900|EG001|Reported Event|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
11116459|NCT01680991|BG000|Baseline|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
11116460|NCT01680991|BG001|Baseline|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116461|NCT01680991|BG002|Baseline|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116462|NCT01680991|BG003|Baseline|Total|Total of all reporting groups
11116463|NCT01680991|FG000|Participant Flow|CLL: 1000 mg Obinutuzumab|Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
11116464|NCT01680991|FG001|Participant Flow|DLBCL: 1000 mg Obinutuzumab|Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116465|NCT01680991|FG002|Participant Flow|FL: 1000 mg Obinutuzumab|Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116466|NCT01680991|OG000|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
11116467|NCT01680991|OG001|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116468|NCT01680991|OG002|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116469|NCT01680991|OG000|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116470|NCT01680991|OG001|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116471|NCT01680991|EG000|Reported Event|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
11116472|NCT01680991|EG001|Reported Event|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116473|NCT01680991|EG002|Reported Event|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
11116474|NCT01681004|BG000|Baseline|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
11116475|NCT01681004|BG001|Baseline|Non-Surgical Management|"Medications, SI joint injection, physical therapy and RF ablation of SI joint~Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
11116476|NCT01681004|BG002|Baseline|Total|Total of all reporting groups
11116477|NCT01681004|FG000|Participant Flow|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
11116478|NCT01681004|FG001|Participant Flow|Non-Surgical Management|"Medications, SI joint injection, physical therapy and RF ablation of SI joint~Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
11116479|NCT01681004|OG000|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
11116480|NCT01681004|OG001|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM with reporting to 6 months only.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
11005515|NCT01080794|EG002|Reported Event|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005516|NCT01080794|EG003|Reported Event|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
11005517|NCT01080807|BG000|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
11005518|NCT01080807|BG001|Baseline|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
11005519|NCT01080807|BG002|Baseline|Total|Total of all reporting groups
11005520|NCT01080807|FG000|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
11005521|NCT01080807|FG001|Participant Flow|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
11005522|NCT01080807|OG000|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
11005523|NCT01080807|OG001|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
11005524|NCT01080807|EG000|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
11116481|NCT01681004|OG001|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
11116482|NCT01681004|OG001|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
11116483|NCT01681004|OG001|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months..~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
11116484|NCT01681004|OG001|Outcome|Non-Surgical Management|This arm includes all subjects randomized to NSM. Many of these subjects crossed over to treatment after 6 months of NSM.
11116485|NCT01681004|EG000|Reported Event|iFuse Implant System|Surgical placement of iFuse implants in the affected SI joint iFuse Implant System: Placement of iFuse implant system via surgery
11116486|NCT01681004|EG001|Reported Event|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months~Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation."
11116487|NCT01681030|BG000|Baseline|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11116488|NCT01681030|BG001|Baseline|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
11116489|NCT01681030|BG002|Baseline|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
11116490|NCT01681030|BG003|Baseline|Total|Total of all reporting groups
11116491|NCT01681030|FG000|Participant Flow|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11116492|NCT01681030|FG001|Participant Flow|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
11116493|NCT01681030|FG002|Participant Flow|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
11116494|NCT01681030|OG000|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11116495|NCT01681030|OG001|Outcome|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
11116496|NCT01681030|OG002|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
11116497|NCT01681030|EG000|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11116498|NCT01681030|EG001|Reported Event|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
11116499|NCT01681030|EG002|Reported Event|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
11116500|NCT01681069|BG000|Baseline|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
11116501|NCT01681069|BG001|Baseline|Placebo|"2 tablets twice a day~Placebo"
11116502|NCT01681069|BG002|Baseline|Total|Total of all reporting groups
11116503|NCT01681069|FG000|Participant Flow|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
11116504|NCT01681069|FG001|Participant Flow|Placebo|"2 tablets twice a day~Placebo"
11116505|NCT01681069|OG000|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
11116506|NCT01681069|OG001|Outcome|Placebo|"2 tablets twice a day~Placebo"
11116507|NCT01681069|EG000|Reported Event|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
11116508|NCT01681069|EG001|Reported Event|Placebo|"2 tablets twice a day~Placebo"
11116509|NCT01681095|BG000|Baseline|Standard Cold Blood Cardioplegia|"55 participants were randomized to Standard cold blood cardioplegia. Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
11116510|NCT01681095|BG001|Baseline|Custiodiol HTK|"55 participants were randomized to Custodiol HTK. Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
11116511|NCT01681095|BG002|Baseline|Total|Total of all reporting groups
11116512|NCT01681095|FG000|Participant Flow|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
11116513|NCT01681095|FG001|Participant Flow|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
11116514|NCT01681095|OG000|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
11116515|NCT01681095|OG001|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
11116516|NCT01681095|EG000|Reported Event|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
11116517|NCT01681095|EG001|Reported Event|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
11116518|NCT01681121|BG000|Baseline|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
11116519|NCT01681121|BG001|Baseline|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
11116520|NCT01681121|BG002|Baseline|Total|Total of all reporting groups
11116521|NCT01681121|FG000|Participant Flow|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
11116522|NCT01681121|FG001|Participant Flow|Placebo|Placebo to match ADX-N05 to be taken once a day for 12 weeks
11116523|NCT01681121|OG000|Outcome|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
11116524|NCT01681121|OG001|Outcome|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
11116525|NCT01681121|OG000|Outcome|ADX-N05|ADX-N05 to be taken once a day for 12 weeks
11116526|NCT01681121|OG001|Outcome|Placebo|Placebo to match ADX-N05 to be taken once a day for 12 weeks
11116527|NCT01681121|EG000|Reported Event|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
11116528|NCT01681121|EG001|Reported Event|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
11116529|NCT01681186|BG000|Baseline|Part A, Cohort 1, Sequence 1|50-milligram (mg) LY2940680 capsule in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study
11116530|NCT01681186|BG001|Baseline|Part A, Cohort 1, Sequence 2|50-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116531|NCT01681186|BG002|Baseline|Part A, Cohort 1, Sequence 3|Placebo in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116532|NCT01681186|BG003|Baseline|Part A, Cohort 2, Sequence 4|100-mg LY2940680 capsule in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116533|NCT01681186|BG004|Baseline|Part A, Cohort 2, Sequence 5|100-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116534|NCT01681186|BG005|Baseline|Part A, Cohort 2, Sequence 6|Placebo in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116535|NCT01681186|BG006|Baseline|Part B, Cohort 3, Sequence 1|100-mg LY2940680 capsule in fasted state in Period 1, then100-mg LY2940680 tablet in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
11116536|NCT01681186|BG007|Baseline|Part B, Cohort 3, Sequence 2|100-mg LY2940680 tablet in fasted state in Period 1, then 100-mg LY2940680 capsule in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
11116537|NCT01681186|BG008|Baseline|Total|Total of all reporting groups
11116538|NCT01681186|FG000|Participant Flow|Part A, Cohort 1, Sequence 1|50-milligram (mg) LY2940680 capsule in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116539|NCT01681186|FG001|Participant Flow|Part A, Cohort 1, Sequence 2|50-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116540|NCT01681186|FG002|Participant Flow|Part A, Cohort 1, Sequence 3|Placebo in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116541|NCT01681186|FG003|Participant Flow|Part A, Cohort 2, Sequence 4|100-mg LY2940680 capsule in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116542|NCT01681186|FG004|Participant Flow|Part A, Cohort 2, Sequence 5|100-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116543|NCT01681186|FG005|Participant Flow|Part A, Cohort 2, Sequence 6|Placebo in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
11116544|NCT01681186|FG006|Participant Flow|Part B, Cohort 3, Sequence 1|100-mg LY2940680 capsule in fasted state in Period 1, then100-mg LY2940680 tablet in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
11116545|NCT01681186|FG007|Participant Flow|Part B, Cohort 3, Sequence 2|100-mg LY2940680 tablet in fasted state in Period 1, then 100-mg LY2940680 capsule in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
11116546|NCT01681186|OG000|Outcome|Placebo Capsule (Fasted)|Placebo capsule given once orally in fasted state during Part A of the study.
11116547|NCT01681186|OG001|Outcome|50-mg LY2940680 Capsule (Fasted)|50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116548|NCT01681186|OG002|Outcome|100-mg LY2940680 Capsule (Fasted) Part A|100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116549|NCT01681186|OG003|Outcome|100-mg LY2940680 Capsule (Fasted) Part B|100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
11116550|NCT01681186|OG004|Outcome|100-mg LY2940680 Tablet (Fasted)|100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
11116551|NCT01681186|OG005|Outcome|100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)|100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole [proton pump inhibitor(PPI)] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
11116552|NCT01681186|OG006|Outcome|100-mg LY2940680 Tablet (Fed)|100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
11116553|NCT01681186|OG007|Outcome|200-mg LY2940680 Capsule (Fasted)|200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116554|NCT01681186|OG008|Outcome|400-mg LY2940680 Capsule (Fasted)|400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116555|NCT01681186|OG000|Outcome|100-mg LY2940680 Capsule (Fasted)|100-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part B of the study.
11116556|NCT01681186|OG001|Outcome|100-mg LY2940680 Tablet (Fasted)|100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
11116557|NCT01681186|OG002|Outcome|100-mg LY2940680 Tablet (Fed)|100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
11116558|NCT01681186|OG003|Outcome|100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)|100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole [proton pump inhibitor (PPI)] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
11116559|NCT01681186|OG000|Outcome|50-mg LY2940680 Capsule (Fasted)|50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116560|NCT01681186|OG001|Outcome|100-mg LY2940680 Capsule (Fasted)|100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116561|NCT01681186|OG002|Outcome|200-mg LY2940680 Capsule (Fasted)|200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116562|NCT01681186|OG003|Outcome|400-mg LY2940680 Capsule (Fasted)|400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116563|NCT01681186|OG002|Outcome|100-mg LY2940680 Tablet (Fed)|100-mg LY2940680 tablet administered once orally in fed state during Part B of the study.
11116564|NCT01681186|OG003|Outcome|100-mg LY2940680 Tablet (Fasted) PPI|100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. Participants were administered 30 mg lansoprazole (proton pump inhibitor (PPI)) once-daily (QD).
11116565|NCT01681186|OG003|Outcome|100-mg LY2940680 Tablet (Fasted) PPI|100-mg LY2940680 tablet administered once orally in fasted state during Part A of the study. Participants were administered 30 mg lansoprazole (proton pump inhibitor (PPI)) once-daily (QD).
11116566|NCT01681186|EG000|Reported Event|Placebo Capsule (Fasted)|Placebo capsule given once orally in fasted state during Part A of the study.
11116567|NCT01681186|EG001|Reported Event|50-mg LY2940680 Capsule (Fasted)|50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116568|NCT01681186|EG002|Reported Event|100-mg LY2940680 Capsule (Fasted) Part A or Part B|100-mg LY2940680 capsule administered once orally in fasted state during Part A or Part B of the study.
11116569|NCT01681186|EG003|Reported Event|100 mg LY2940680 Tablet (Fasted)|100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
11116570|NCT01681186|EG004|Reported Event|100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)|100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole [proton pump inhibitor (PPI)] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
11116571|NCT01681186|EG005|Reported Event|100-mg LY2940680 Tablet (Fed)|100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
11116572|NCT01681186|EG006|Reported Event|200-mg LY2940680 Capsule (Fasted)|200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116573|NCT01681186|EG007|Reported Event|400-mg LY2940680 Capsule (Fasted)|400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
11116574|NCT01681212|BG000|Baseline|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
11116575|NCT01681212|FG000|Participant Flow|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression, unacceptable toxicity, or withdrawal of consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
11116576|NCT01681212|OG000|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
11116577|NCT01681212|EG000|Reported Event|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
11116578|NCT01681277|BG000|Baseline|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
11116579|NCT01681277|BG001|Baseline|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116580|NCT01681277|BG002|Baseline|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11126774|NCT01735279|OG001|Outcome|Omega3|omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
11116581|NCT01681277|BG003|Baseline|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116582|NCT01681277|BG004|Baseline|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
11116583|NCT01681277|BG005|Baseline|Total|Total of all reporting groups
11116584|NCT01681277|FG000|Participant Flow|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
11116585|NCT01681277|FG001|Participant Flow|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116586|NCT01681277|FG002|Participant Flow|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116587|NCT01681277|FG003|Participant Flow|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116588|NCT01681277|FG004|Participant Flow|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
11116589|NCT01681277|OG000|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
11116590|NCT01681277|OG001|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116591|NCT01681277|OG002|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116592|NCT01681277|OG003|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116593|NCT01681277|OG004|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
11116594|NCT01681277|OG000|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116595|NCT01681277|OG001|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116596|NCT01681277|OG002|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116597|NCT01681277|OG003|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
11116598|NCT01681277|EG000|Reported Event|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
11126775|NCT01735279|EG000|Reported Event|Placebo Group n= 29|placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.
11116599|NCT01681277|EG001|Reported Event|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116600|NCT01681277|EG002|Reported Event|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116601|NCT01681277|EG003|Reported Event|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
11116602|NCT01681277|EG004|Reported Event|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
11116603|NCT01681368|BG000|Baseline|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
11116604|NCT01681368|FG000|Participant Flow|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
11116605|NCT01681368|OG000|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
11116606|NCT01681368|EG000|Reported Event|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
11116607|NCT01681433|BG000|Baseline|Experimental: Arm A|"OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone~OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV~Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily~Prednisone: Standard therapy: Prednisone 10-20 mg PO daily"
11116608|NCT01681433|BG001|Baseline|Control Arm: Arm B|"Continuation of standard therapy with abiraterone acetate and prednisone~Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily~Prednisone: Standard therapy: Prednisone 10-20 mg PO daily"
11116609|NCT01681433|BG002|Baseline|Total|Total of all reporting groups
11116610|NCT01681433|FG000|Participant Flow|Experimental: Arm A|"OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone~OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV~Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily~Prednisone: Standard therapy: Prednisone 10-20 mg PO daily"
11116611|NCT01681433|FG001|Participant Flow|Control Arm: Arm B|"Continuation of standard therapy with abiraterone acetate and prednisone~Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily~Prednisone: Standard therapy: Prednisone 10-20 mg PO daily"
11116612|NCT01681433|OG000|Outcome|Experimental: Arm A|"OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone~OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV~Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily~Prednisone: Standard therapy: Prednisone 10-20 mg PO daily"
11116613|NCT01681433|OG001|Outcome|Control Arm: Arm B|"Continuation of standard therapy with abiraterone acetate and prednisone~Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily~Prednisone: Standard therapy: Prednisone 10-20 mg PO daily"
11116614|NCT01681433|EG000|Reported Event|Experimental: Arm A|"OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone~OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV~Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily~Prednisone: Standard therapy: Prednisone 10-20 mg PO daily"
11116615|NCT01681433|EG001|Reported Event|Control Arm: Arm B|"Continuation of standard therapy with abiraterone acetate and prednisone~Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily~Prednisone: Standard therapy: Prednisone 10-20 mg PO daily"
11116616|NCT01681472|BG000|Baseline|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
11116617|NCT01681472|BG001|Baseline|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
11116618|NCT01681472|BG002|Baseline|Modufolin 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116619|NCT01681472|BG003|Baseline|Modufolin 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116620|NCT01681472|BG004|Baseline|Total|Total of all reporting groups
11116621|NCT01681472|FG000|Participant Flow|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
11116622|NCT01681472|FG001|Participant Flow|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
11116623|NCT01681472|FG002|Participant Flow|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116624|NCT01681472|FG003|Participant Flow|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116625|NCT01681472|OG000|Outcome|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
11116626|NCT01681472|OG001|Outcome|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
11116627|NCT01681472|OG002|Outcome|Modufolin 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116628|NCT01681472|OG003|Outcome|Modufolin 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116629|NCT01681472|OG000|Outcome|L-LV(200)|Levoleucovorin 200 mg/m2
11116630|NCT01681472|OG001|Outcome|L-LV(60)|Levoleucovorin 60 mg/m2
11116631|NCT01681472|OG002|Outcome|Mod(200)|Modufolin 200 mg/m2
11116632|NCT01681472|OG003|Outcome|Mod(60)|Modufolin 60 mg/m2
11116633|NCT01681472|OG000|Outcome|Modufolin 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116634|NCT01681472|OG001|Outcome|Modufolin 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116635|NCT01681472|OG002|Outcome|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
11116636|NCT01681472|OG003|Outcome|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
11116637|NCT01681472|OG003|Outcome|Modufolin mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116638|NCT01681472|EG000|Reported Event|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
11116639|NCT01681472|EG001|Reported Event|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
11116640|NCT01681472|EG002|Reported Event|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116641|NCT01681472|EG003|Reported Event|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
11116642|NCT01681511|BG000|Baseline|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
11116643|NCT01681511|BG001|Baseline|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
11116644|NCT01681511|BG002|Baseline|Total|Total of all reporting groups
11116645|NCT01681511|FG000|Participant Flow|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
11116646|NCT01681511|FG001|Participant Flow|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
11116647|NCT01681511|OG000|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
11116648|NCT01681511|OG001|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
11116649|NCT01681511|EG000|Reported Event|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
11116650|NCT01681511|EG001|Reported Event|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
11116651|NCT01681576|BG000|Baseline|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
11116652|NCT01681576|BG001|Baseline|Valsartan 320mg|Period 1: 4 weeks treatment with Valsartan 320mg QD, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with LCZ696 400mg QD
11116653|NCT01681576|BG002|Baseline|Total|Total of all reporting groups
11116654|NCT01681576|FG000|Participant Flow|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
11116655|NCT01681576|FG001|Participant Flow|Valsartan Followed by LCZ696|Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
11116656|NCT01681576|OG000|Outcome|LCZ696 - ALL|LCZ696 400mg QD
11116657|NCT01681576|OG001|Outcome|Valsartan -ALL|Valsartan 320mg QD
11116658|NCT01681576|OG000|Outcome|LCZ696 - ALL|LCZ696 400mg
11116659|NCT01681576|OG001|Outcome|Valsartan - ALL|Valsartan 320mg QD
11116660|NCT01681576|EG000|Reported Event|LCZ696 400 mg QD|LCZ696 400 mg QD
11116661|NCT01681576|EG001|Reported Event|Valsartan 320 mg QD|Valsartan 320 mg QD
11126776|NCT01735279|EG001|Reported Event|Omega3 Group n= 29|omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
11116662|NCT01681628|BG000|Baseline|Thought Field Therapy (TFT)|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 months later"
11116663|NCT01681628|BG001|Baseline|Wait List|"Delayed intervention.~No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 mo the later."
11116664|NCT01681628|BG002|Baseline|Total|Total of all reporting groups
11116665|NCT01681628|FG000|Participant Flow|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
11116666|NCT01681628|FG001|Participant Flow|Wait List|"Delayed intervention.~No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
11116667|NCT01681628|OG000|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
11116668|NCT01681628|OG001|Outcome|Wait List: no Therapy|"No thought field therapy intervention prior to assessment after one week (pre-test 2).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
11116669|NCT01681628|OG002|Outcome|Wait-list: Thought Field Therapy|"Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
11116670|NCT01681628|OG001|Outcome|Wait List no Treatment|"No intervention prior to assessment after one week (pre-test 2).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
11116671|NCT01681628|OG002|Outcome|Wait List: Thought Field Therapy|After two control assessments at times 1 and 2, the wait list group were treated and re-assessed one week later at time 3. Non-attenders at time 3 were excluded from analysis.
11116672|NCT01681628|OG000|Outcome|Wait List Group|Those in the wait list, who had attended for their second immediate pre-treatment assessment and attended for assessment 19 months later.
11116673|NCT01681628|EG000|Reported Event|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 months later"
11116674|NCT01681771|BG000|Baseline|Cogntive Behaviour Therapy|"Internet based Cognitive behaviour therapy during 9 weeks~Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional."
11116675|NCT01681771|BG001|Baseline|Discussion Group|"Internet moderated discussion group during 9 weeks~Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.~Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others."
11116676|NCT01681771|BG002|Baseline|Total|Total of all reporting groups
11116677|NCT01681771|FG000|Participant Flow|Cogntive Behaviour Therapy|"Internet based Cognitive behaviour therapy during 9 weeks~Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional."
11116678|NCT01681771|FG001|Participant Flow|Discussion Group|"Internet moderated discussion group during 9 weeks~Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.~Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others."
11116679|NCT01681771|OG000|Outcome|Cogntive Behaviour Therapy|"Internet based Cognitive behaviour therapy during 9 weeks~Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional."
11116680|NCT01681771|OG001|Outcome|Discussion Group|"Internet moderated discussion group during 9 weeks~Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.~Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others."
11116681|NCT01681771|EG000|Reported Event|Cognitive Behavoural Therapy|
11116682|NCT01681771|EG001|Reported Event|Discussion Group|
11116683|NCT01681810|BG000|Baseline|14Nitrogen Sodium Nitrite|"sodium nitrite 40 mg three times a day for 12 weeks~14Nitrogen Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times a day for 12 weeks"
11116684|NCT01681810|FG000|Participant Flow|14Nitrogen Sodium Nitrite|"sodium nitrite 40 mg three times a day for 12 weeks~14Nitrogen Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times a day for 12 weeks"
11116685|NCT01681810|OG000|Outcome|14Nitrogen Sodium Nitrite|"sodium nitrite 40 mg three times a day for 12 weeks~14Nitrogen Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times a day for 12 weeks"
11116686|NCT01681810|EG000|Reported Event|14Nitrogen Sodium Nitrite|"sodium nitrite 40 mg three times a day for 12 weeks~14Nitrogen Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times a day for 12 weeks"
11116687|NCT01681836|BG000|Baseline|Entire Study Population|Includes groups randomized to received oral 15N-labeled sodium nitrate first and sodium nitrite first.
11116688|NCT01681836|FG000|Participant Flow|Oral 15N-labeled Sodium Nitrate, Then Sodium Nitrite|Oral 15N-labeled sodium nitrate 1,000 mg once in first intervention period and oral 15N-labeled sodium nitrite 20 mg once in second intervention period (after washout period)
11116689|NCT01681836|FG001|Participant Flow|Oral 15N-labeled Sodium Nitrite, Then Sodium Nitrate|Oral 15N-labeled sodium nitrite 20 mg once in first intervention period and oral 15N-labeled sodium nitrate 1,000 mg once in second intervention period (after washout period)
11116690|NCT01681836|OG000|Outcome|Oral 15N-labeled Sodium Nitrate|Oral 15N-labeled sodium nitrate 1,000 mg once in either first intervention period or second intervention period
11116691|NCT01681836|OG001|Outcome|Oral 15N-labeled Sodium Nitrite|Oral 15N-labeled sodium nitrite 20 mg once in either first intervention period or second intervention period
11116692|NCT01681836|EG000|Reported Event|Oral 15N-labeled Sodium Nitrate|Oral 15N-labeled sodium nitrate 1,000 mg once in either first intervention period or second intervention period
11116693|NCT01681836|EG001|Reported Event|Oral 15N-labeled Sodium Nitrite|Oral 15N-labeled sodium nitrite 20 mg once in either first intervention period or second intervention period
11116694|NCT01681849|BG000|Baseline|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116695|NCT01681849|BG001|Baseline|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116696|NCT01681849|BG002|Baseline|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116697|NCT01681849|BG003|Baseline|Total|Total of all reporting groups
11116698|NCT01681849|FG000|Participant Flow|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116699|NCT01681849|FG001|Participant Flow|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116700|NCT01681849|FG002|Participant Flow|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116701|NCT01681849|OG000|Outcome|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116702|NCT01681849|OG001|Outcome|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11126777|NCT01735396|BG000|Baseline|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
11126778|NCT01735396|FG000|Participant Flow|Abiraterone Acetate|"Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.~Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily"
11116703|NCT01681849|EG000|Reported Event|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116704|NCT01681849|EG001|Reported Event|Placebo Group|"Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116705|NCT01681849|EG002|Reported Event|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
11116706|NCT01681992|BG000|Baseline|Inv_MMR_Min Group|Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116707|NCT01681992|BG001|Baseline|Inv_MMR_Med Group|Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116708|NCT01681992|BG002|Baseline|Com_MMR Group|Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116709|NCT01681992|BG003|Baseline|Total|Total of all reporting groups
11116710|NCT01681992|FG000|Participant Flow|Inv_MMR_Min Group|Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116711|NCT01681992|FG001|Participant Flow|Inv_MMR_Med Group|Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116712|NCT01681992|FG002|Participant Flow|Com_MMR Group|Subjects received one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116713|NCT01681992|OG000|Outcome|Inv_MMR_Min Group|Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116714|NCT01681992|OG001|Outcome|Inv_MMR_Med Group|Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116715|NCT01681992|OG002|Outcome|Com_MMR Group|Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116716|NCT01681992|EG000|Reported Event|Inv_MMR_Min Group|Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116717|NCT01681992|EG001|Reported Event|Inv_MMR_Med Group|Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116718|NCT01681992|EG002|Reported Event|Com_MMR Group|Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11116719|NCT01682031|BG000|Baseline|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
11116720|NCT01682031|BG001|Baseline|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
11116721|NCT01682031|BG002|Baseline|Total|Total of all reporting groups
11116722|NCT01682031|FG000|Participant Flow|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
11116723|NCT01682031|FG001|Participant Flow|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
11116724|NCT01682031|OG000|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
11116725|NCT01682031|OG001|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
11116726|NCT01682031|EG000|Reported Event|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
11116727|NCT01682031|EG001|Reported Event|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
11116728|NCT01682044|BG000|Baseline|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
11116729|NCT01682044|FG000|Participant Flow|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
11116730|NCT01682044|OG000|Outcome|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
11116731|NCT01682044|EG000|Reported Event|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
11116732|NCT01682083|BG000|Baseline|Dabrafenib and Trametinib Combination Therapy|Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
11116733|NCT01682083|BG001|Baseline|Dabrafenib and Trametinib Placebos|Subjects received matching placebos orally for 12 months
11116734|NCT01682083|BG002|Baseline|Total|Total of all reporting groups
11116735|NCT01682083|FG000|Participant Flow|Dabrafenib and Trametinib Combination Therapy|Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
11116736|NCT01682083|FG001|Participant Flow|Dabrafenib and Trametinib Placebos|Subjects received matching placebos orally for 12 months
11116737|NCT01682083|OG000|Outcome|Dabrafenib and Trametinib Combination Therapy|Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
11116738|NCT01682083|OG001|Outcome|Dabrafenib and Trametinib Placebos|Subjects received matching placebos orally for 12 months
11116739|NCT01682083|EG000|Reported Event|Dabrafenib + Trametinib Combination Therapy|Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
11116740|NCT01682083|EG001|Reported Event|Dabrafenib and Trametinib Placebos|Subjects received matching placebos orally for 12 months
11116741|NCT01682135|BG000|Baseline|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 2. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
11116742|NCT01682135|BG001|Baseline|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 3. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
11116743|NCT01682135|BG002|Baseline|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
11116744|NCT01682135|BG003|Baseline|Total|Total of all reporting groups
11116745|NCT01682135|FG000|Participant Flow|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
11116746|NCT01682135|FG001|Participant Flow|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
11116747|NCT01682135|FG002|Participant Flow|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
11116748|NCT01682135|OG000|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
11116749|NCT01682135|OG001|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
11116750|NCT01682135|OG002|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
11116751|NCT01682135|OG000|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
11116752|NCT01682135|OG002|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
11116753|NCT01682135|EG000|Reported Event|Cohort 1 - 6mg/kg/2w Ramucirumab|6mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
11116754|NCT01682135|EG001|Reported Event|Cohort 2 - 10mg/kg/3w Ramucirumab|10mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
11116755|NCT01682135|EG002|Reported Event|Cohort 3 - 8mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
11126779|NCT01735396|OG000|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
11126780|NCT01735396|EG000|Reported Event|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
11116756|NCT01682148|BG000|Baseline|NMJ Targeted|NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116757|NCT01682148|BG001|Baseline|Current Clinical Practice|Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116758|NCT01682148|BG002|Baseline|Total|Total of all reporting groups
11116759|NCT01682148|FG000|Participant Flow|NMJ Targeted|Neuromuscular junction (NMJ) targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116760|NCT01682148|FG001|Participant Flow|Current Clinical Practice|Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116761|NCT01682148|OG000|Outcome|NMJ Targeted (ITT Population)|NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116762|NCT01682148|OG001|Outcome|Current Clinical Practice (ITT Population)|Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116763|NCT01682148|OG002|Outcome|NMJ Targeted (PP Population)|NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116764|NCT01682148|OG003|Outcome|Current Clinical Practice (PP Population)|Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116765|NCT01682148|OG000|Outcome|NMJ Targeted|NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116766|NCT01682148|OG001|Outcome|Current Clinical Practice|Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116767|NCT01682148|OG000|Outcome|Number of Investigators Who Responded|Investigator preference for using the NMJ Targeted versus the Current Clinical Practice technique was requested at each of the 20 sites (20 Investigators).
11116768|NCT01682148|EG000|Reported Event|NMJ Targeted|NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
11116769|NCT01682148|EG001|Reported Event|Current Clinical Practice|Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment .
11116770|NCT01682213|BG000|Baseline|Dabrafenib|"This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation.~Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days."
11116771|NCT01682213|FG000|Participant Flow|Dabrafenib|"This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation.~Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days."
11116772|NCT01682213|OG000|Outcome|Dabrafenib|"This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation.~Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days."
11116773|NCT01682213|OG000|Outcome|Dabrafenib|This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation.
11116774|NCT01682213|EG000|Reported Event|Dabrafenib|This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation.
11116775|NCT01682460|BG000|Baseline|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
11116776|NCT01682460|FG000|Participant Flow|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
11116777|NCT01682460|OG000|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
11116778|NCT01682460|EG000|Reported Event|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
11116779|NCT01682512|BG000|Baseline|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116780|NCT01682512|BG001|Baseline|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116781|NCT01682512|BG002|Baseline|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116782|NCT01682512|BG003|Baseline|Total|Total of all reporting groups
11116783|NCT01682512|FG000|Participant Flow|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116784|NCT01682512|FG001|Participant Flow|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116785|NCT01682512|FG002|Participant Flow|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116786|NCT01682512|OG000|Outcome|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116787|NCT01682512|OG001|Outcome|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116788|NCT01682512|OG002|Outcome|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116789|NCT01682512|EG000|Reported Event|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116790|NCT01682512|EG001|Reported Event|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116791|NCT01682512|EG002|Reported Event|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
11116792|NCT01682538|BG000|Baseline|Overall Study|All treatment arms
11116793|NCT01682538|FG000|Participant Flow|All Treatment Groups|"All participants received all study treatments in a randomized fashion. Subjects were allocated to one of the following treatment sequences (2 subjects to each sequence):~A B C; B C A; C A B; C B A; A C B; B A C where A=Orfadin capsules, single dose, 30 mg; B=Orfadin suspension, single dose 30 mg, fasting; C=Orfadin suspension, single dose 30 mg, fed"
11116794|NCT01682538|OG000|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
11116795|NCT01682538|OG001|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
11116796|NCT01682538|OG000|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
11116797|NCT01682538|OG001|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
11116798|NCT01682538|OG002|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
11116799|NCT01682538|OG001|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
11116800|NCT01682538|OG002|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
11116801|NCT01682538|OG001|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
11116802|NCT01682538|OG002|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
11116803|NCT01682538|OG001|Outcome|Orfadin Suspension, Fasting|Orfadin suspension, 4 mg/mL, single dose, 30 mg (7.5 mL)
11116804|NCT01682538|EG000|Reported Event|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
11116805|NCT01682538|EG001|Reported Event|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
11116806|NCT01682538|EG002|Reported Event|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
11116807|NCT01682603|BG000|Baseline|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
11116808|NCT01682603|FG000|Participant Flow|Botulinum Toxin A|Botulinum toxin A (BoNT-A) (BOTOX 300U)
11116809|NCT01682603|OG000|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
11116810|NCT01682603|OG000|Outcome|Pre-Autonomic Dysreflexia|Baseline Autonomic dysreflexia
11116811|NCT01682603|OG001|Outcome|Pre-Non Autonomic Dysreflexia|Baseline Non autonomic dysreflexia
11116812|NCT01682603|EG000|Reported Event|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
11116813|NCT01682642|BG000|Baseline|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
11116814|NCT01682642|BG001|Baseline|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
11116815|NCT01682642|BG002|Baseline|Total|Total of all reporting groups
11116816|NCT01682642|FG000|Participant Flow|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment.
11116817|NCT01682642|FG001|Participant Flow|Vaporization Only|After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).
11116818|NCT01682642|OG000|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
11116819|NCT01682642|OG001|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
11116820|NCT01682642|OG000|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVF treatment.
11116821|NCT01682642|OG000|Outcome|Zoladex|
11116822|NCT01682642|OG000|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVFtreatment.
11116823|NCT01682642|OG001|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
11116824|NCT01682642|OG000|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start IVF treatment.
11116825|NCT01682642|OG000|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following ivf treatment.
11116826|NCT01682642|EG000|Reported Event|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
11116827|NCT01682642|EG001|Reported Event|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
11116828|NCT01682681|BG000|Baseline|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
11116829|NCT01682681|FG000|Participant Flow|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
11116830|NCT01682681|OG000|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
11116831|NCT01682681|EG000|Reported Event|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
11116832|NCT01682720|BG000|Baseline|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.
11116833|NCT01682720|BG001|Baseline|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
11116834|NCT01682720|BG002|Baseline|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
11116835|NCT01682720|BG003|Baseline|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
11116836|NCT01682720|BG004|Baseline|Total|Total of all reporting groups
11116837|NCT01682720|FG000|Participant Flow|Placebo 12 Weeks (GT2/3)|Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.
11116838|NCT01682720|FG001|Participant Flow|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
11116839|NCT01682720|FG002|Participant Flow|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
11116840|NCT01682720|FG003|Participant Flow|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
11116841|NCT01682720|OG000|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
11116842|NCT01682720|OG001|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
11116843|NCT01682720|OG002|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
11116844|NCT01682720|OG000|Outcome|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
11116845|NCT01682720|OG001|Outcome|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
11116846|NCT01682720|EG000|Reported Event|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
11116847|NCT01682720|EG001|Reported Event|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
11116848|NCT01682720|EG002|Reported Event|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
11116849|NCT01682759|BG000|Baseline|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
11116850|NCT01682759|BG001|Baseline|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
11116851|NCT01682759|BG002|Baseline|Total|Total of all reporting groups
11116852|NCT01682759|FG000|Participant Flow|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
11116853|NCT01682759|FG001|Participant Flow|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
11116854|NCT01682759|OG000|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
11116855|NCT01682759|OG001|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
11116856|NCT01682759|EG000|Reported Event|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
11116857|NCT01682759|EG001|Reported Event|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
11116858|NCT01682811|BG000|Baseline|Experimental: Part 1 Levulan Injection|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 3 hr incubation, and by Levulan treated lesions after 3 or 24 hr incubation.
11116859|NCT01682811|BG001|Baseline|Part 1 Levulan Painting|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 3 hr incubation, and by Levulan treated lesions and 3 or 24 hr incubation.
11116860|NCT01682811|BG002|Baseline|Part 1 Levulan Painted Twice|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation.
11116861|NCT01682811|BG003|Baseline|Part 1 Levulan Painted Twice With Microneedling|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. All lesions prepared with microneedling.
11116862|NCT01682811|BG004|Baseline|Part 2 Dose Level 1 50 J/cm^2|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116863|NCT01682811|BG005|Baseline|Part 2 Dose Level 2 100 J/cm^2|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116864|NCT01682811|BG006|Baseline|Part 2 Dose Level 3 200 J/cm^2|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 - 200 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116865|NCT01682811|BG007|Baseline|Total|Total of all reporting groups
11116866|NCT01682811|FG000|Participant Flow|Part 1 Levulan Injection|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 3 hr incubation, and by Levulan treated lesions after 3 or 24 hr incubation.
11116867|NCT01682811|FG001|Participant Flow|Part 1 Levulan Painting|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 3 hr incubation, and by Levulan treated lesions and 3 or 24 hr incubation.
11116868|NCT01682811|FG002|Participant Flow|Experimental: Part 1 Levulan Painted Twice|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation.
11116869|NCT01682811|FG003|Participant Flow|Part 1 Levulan Painted Twice With Microneedling|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. All lesions prepared with microneedling.
11116870|NCT01682811|FG004|Participant Flow|Part 2 Dose Level 1 50 J/cm^2|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116871|NCT01682811|FG005|Participant Flow|Part 2 Dose Level 2 100 J/cm^2|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116872|NCT01682811|FG006|Participant Flow|Part 2 Dose Level 3 200 J/cm^2|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 - 200 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116873|NCT01682811|OG000|Outcome|Part 1 Levulan Injection Control Lesions|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 24 hr incubation.
11116874|NCT01682811|OG001|Outcome|Part 1 Levulan Injection Treated Lesions 3 Hours|5-aminolevulinic acid uptake by treated lesions after Levulan injection and 3 hr incubation.
11116875|NCT01682811|OG002|Outcome|Part 1 Levulan Injection Treated Lesions 24 Hours|5-aminolevulinic acid uptake by treated lesions after Levulan injection and 24 hr incubation.
11116876|NCT01682811|OG003|Outcome|Part 1 Levulan Paint Control Lesions|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 24 hr incubation.
11116877|NCT01682811|OG004|Outcome|Part 1 Levulan Paint Treated Lesions 3 Hours|5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 3 hr incubation.
11116878|NCT01682811|OG005|Outcome|Part 1 Levulan Paint Treated Lesions 24 Hours|5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 24 hr incubation.
11116879|NCT01682811|OG006|Outcome|Part 1 Levulan Painted Twice Control Lesions|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice and 3 hr incubation.
11116880|NCT01682811|OG007|Outcome|Part 1 Levulan Painted Twice Treated Lesions|5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice and 3 hr incubation.
11116881|NCT01682811|OG008|Outcome|Part 1 Levulan Painted Twice Control Lesions With Microneedling|5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
11116882|NCT01682811|OG009|Outcome|Part 1 Levulan Painted Twice Treated Lesions With Microneedling|5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
11116883|NCT01682811|OG000|Outcome|All Participants|All participants who received at least 1 dose of 633 nm red light, either at 50 J/cm^2, 100 J/cm^2, or 200 J/cm^2.
11116884|NCT01682811|OG000|Outcome|Part 2 Dose Level 1 50 J/cm^2 Control|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116885|NCT01682811|OG001|Outcome|Part 2 Dose Level 1 50 J/cm^2 Treated|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116886|NCT01682811|OG000|Outcome|Part 2 Levulan (5-aminolevulinic Acid) Photodynamic Therapy.|"Levulan (5-aminolevulinic acid) photodynamic therapy. 2-18 adult subjects with 3-8 lesions per (Levulan or control) group per subject. Controls will consist of lesions treated with vehicle only and light illumination, and will be paired with treatment lesions by the study doctor. Control lesions will be treated on the same subject as study lesions. Levulan will be incubated for 3-24 hours under occlusion, then gently rinsed with water and patted dry. Photoactivation of lesions treated with Levulan is then accomplished with 630 nm red light illumination. 630 nm light will be applied for varying periods of time in order to achieve a dose of 25, 50, or 100 J/cm2. There will be one treatment session per subject. Treatments will include a minimum of three test lesions and an additional three control lesions.~Subjects will be seen at 24-48 hrs (48-72 hrs after Levulan application), and two weeks to one month after treatment at which times evaluation regarding dose toxicity will be made. Evaluations will include direct measurement of lesions, pain score, and cosmetic improvement (patient satisfaction).~At the 2 day follow up visit, tumors will be punch biopsied, samples preserved in paraffin or formalin, and evaluated for cell death using TUNEL assays, H & E staining, or other methods."
11116887|NCT01682811|EG000|Reported Event|Part 1 Levulan (5-aminolevulinic Acid) Uptake.|Tumors will be incubated with Levulan or vehicle under occlusion for 3 or 24 hrs. A minimum of three tumors per treatment or control group will be treated on the same subject. Tumors will then be excised in the normal manner. Tumors will be sectioned vertically and checked for PpIX using fluorescence microscopy.
11116888|NCT01682811|EG001|Reported Event|Experimental: Part 2 Dose Level 1 50 J/cm^2|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116889|NCT01682811|EG002|Reported Event|Part 2 Dose Level 2 100 J/cm^2|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
11116890|NCT01682837|BG000|Baseline|All Study Participants|Participants received the following study drug in random order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
11116891|NCT01682837|FG000|Participant Flow|All Study Participants|Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.
11116892|NCT01682837|OG000|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
11116893|NCT01682837|OG001|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
11116894|NCT01682837|OG002|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
11116895|NCT01682837|OG003|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
11116896|NCT01682837|EG000|Reported Event|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
11116897|NCT01682837|EG001|Reported Event|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
11116898|NCT01682837|EG002|Reported Event|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
11116899|NCT01682837|EG003|Reported Event|Placebo Phase|Participants undergoing the Placebo phase of the study.
11116900|NCT01682863|BG000|Baseline|QVA149 27.5/12.5 ug Bid|
11116901|NCT01682863|BG001|Baseline|QVA149 27.5/25 ug Bid|
11116902|NCT01682863|BG002|Baseline|QAB149 75 ug od|
11116903|NCT01682863|BG003|Baseline|Total|Total of all reporting groups
11116904|NCT01682863|FG000|Participant Flow|QVA149 27.5/12.5 ug Bid|
11116905|NCT01682863|FG001|Participant Flow|QVA149 27.5/25 ug Bid|
11116906|NCT01682863|FG002|Participant Flow|QAB149 75 ug od|
11116907|NCT01682863|OG000|Outcome|QVA149 27.5/12.5 ug Bid|
11116908|NCT01682863|OG001|Outcome|QVA149 27.5/25 ug Bid|
11116909|NCT01682863|OG002|Outcome|QAB149 75 ug od|
11116910|NCT01682863|EG000|Reported Event|QVA149 27.5/12.5 ug Bid|
11116911|NCT01682863|EG001|Reported Event|QVA149 27.5/25 ug Bid|
11116912|NCT01682863|EG002|Reported Event|QAB75|QVA149 27.5/25 μg capsules
11116913|NCT01682876|BG000|Baseline|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
11116914|NCT01682876|BG001|Baseline|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
11116915|NCT01682876|BG002|Baseline|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
11116916|NCT01682876|BG003|Baseline|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
11116917|NCT01682876|BG004|Baseline|Total|Total of all reporting groups
11116918|NCT01682876|FG000|Participant Flow|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
11116919|NCT01682876|FG001|Participant Flow|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
11116920|NCT01682876|FG002|Participant Flow|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
11116921|NCT01682876|FG003|Participant Flow|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
11116922|NCT01682876|OG000|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
11116923|NCT01682876|OG001|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
11116924|NCT01682876|OG002|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
11116925|NCT01682876|OG003|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
11116926|NCT01682876|OG000|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
11116927|NCT01682876|OG001|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
11116928|NCT01682876|EG000|Reported Event|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
11116929|NCT01682876|EG001|Reported Event|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
11116930|NCT01682876|EG002|Reported Event|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
11116931|NCT01682876|EG003|Reported Event|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
11116932|NCT01682876|EG004|Reported Event|Total|Total Population
11116933|NCT01682954|BG000|Baseline|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
11116934|NCT01682954|BG001|Baseline|Usual Care|Usual care from primary care physician
11116935|NCT01682954|BG002|Baseline|Total|Total of all reporting groups
11116936|NCT01682954|FG000|Participant Flow|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
11116937|NCT01682954|FG001|Participant Flow|Usual Care|Usual care from primary care physician
11116938|NCT01682954|OG000|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
11116939|NCT01682954|OG001|Outcome|Usual Care|Usual care from primary care physician
11116940|NCT01682954|EG000|Reported Event|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
11116941|NCT01682954|EG001|Reported Event|Usual Care|Usual care from primary care physician
11116942|NCT01683019|BG000|Baseline|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
11116943|NCT01683019|BG001|Baseline|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
11116944|NCT01683019|BG002|Baseline|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
11116945|NCT01683019|BG003|Baseline|Total|Total of all reporting groups
11116946|NCT01683019|FG000|Participant Flow|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
11116947|NCT01683019|FG001|Participant Flow|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
11116948|NCT01683019|FG002|Participant Flow|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
11116949|NCT01683019|OG000|Outcome|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
11116950|NCT01683019|OG001|Outcome|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
11116951|NCT01683019|OG002|Outcome|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
11116952|NCT01683019|EG000|Reported Event|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
11116953|NCT01683019|EG001|Reported Event|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
11116954|NCT01683019|EG002|Reported Event|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
11116955|NCT01683058|BG000|Baseline|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
11116956|NCT01683058|FG000|Participant Flow|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
11116957|NCT01683058|OG000|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
11116958|NCT01683058|OG000|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
11116959|NCT01683058|EG000|Reported Event|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
11116960|NCT01683071|BG000|Baseline|(Part 1) EXPAREL 67 mg|5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116961|NCT01683071|BG001|Baseline|(Part 1) EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116962|NCT01683071|BG002|Baseline|(Part 1) EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
11116963|NCT01683071|BG003|Baseline|(Part 1) Placebo|20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116964|NCT01683071|BG004|Baseline|(Part 2) EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
11116965|NCT01683071|BG005|Baseline|(Part 2) Placebo|20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116966|NCT01683071|BG006|Baseline|Total|Total of all reporting groups
11116967|NCT01683071|FG000|Participant Flow|(Part 1) EXPAREL 67 mg|5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116968|NCT01683071|FG001|Participant Flow|(Part 1) EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116969|NCT01683071|FG002|Participant Flow|(Part 1) EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
11116970|NCT01683071|FG003|Participant Flow|(Part 1) Placebo|20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116971|NCT01683071|FG004|Participant Flow|(Part 2) EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
11116972|NCT01683071|FG005|Participant Flow|(Part 2) Placebo|20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116973|NCT01683071|OG000|Outcome|(Part 1) EXPAREL 67 mg|"5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively~EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg"
11116974|NCT01683071|OG001|Outcome|(Part 1) EXPAREL 133 mg|"10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively~EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg"
11116975|NCT01683071|OG002|Outcome|(Part 1) EXPAREL 266 mg|"20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively~EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg"
11116976|NCT01683071|OG003|Outcome|(Part 1) Placebo|"20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively~Placebo: Normal saline 20 mL"
11116977|NCT01683071|OG004|Outcome|(Part 2) EXPAREL 266 mg|"20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively~EXPAREL: EXPAREL 67 mg, 133 mg, or 266 mg"
11116978|NCT01683071|OG005|Outcome|(Part 2) Placebo|"20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively~Placebo: Normal saline 20 mL"
11116979|NCT01683071|OG000|Outcome|(Part 1) EXPAREL 67 mg|5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116980|NCT01683071|OG001|Outcome|(Part 1) EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116981|NCT01683071|OG002|Outcome|(Part 1) EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
11348351|NCT04179461|BG000|Baseline|Personalized Treatment|"Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.~Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.~Cholecalciferol: Oral administration~antihistamine: Oral administration~Azithromycin: Oral administration~emollient cream: Topical~Fluticasone Propionate: Nasal spray~Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."
11116982|NCT01683071|OG003|Outcome|(Part 1) Placebo|20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116983|NCT01683071|OG004|Outcome|(Part 2) EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
11116984|NCT01683071|OG005|Outcome|(Part 2) Placebo|20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116985|NCT01683071|EG000|Reported Event|(Part 1) EXPAREL 67 mg|5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116986|NCT01683071|EG001|Reported Event|(Part 1) EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116987|NCT01683071|EG002|Reported Event|(Part 1) EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
11116988|NCT01683071|EG003|Reported Event|(Part 1) Placebo|20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116989|NCT01683071|EG004|Reported Event|(Part 2) EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
11116990|NCT01683071|EG005|Reported Event|(Part 2) Placebo|20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
11116991|NCT01683266|BG000|Baseline|HOE901--U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
11116992|NCT01683266|BG001|Baseline|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
11116993|NCT01683266|BG002|Baseline|Total|Total of all reporting groups
11116994|NCT01683266|FG000|Participant Flow|HOE901--U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
11116995|NCT01683266|FG001|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
11116996|NCT01683266|OG000|Outcome|HOE901--U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
11116997|NCT01683266|OG001|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
11116998|NCT01683266|EG000|Reported Event|HOE901--U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
11116999|NCT01683266|EG001|Reported Event|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
11117000|NCT01683331|BG000|Baseline|Insulin Treatment for Hyperglycemia|NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG > 240, NPH initiation: 14, dose increases by 4; For pts. with CPG > 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG > 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG > 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG <60 mg/dl, NPH initiation: 0, ½ of previous dose.
11117001|NCT01683331|BG001|Baseline|Standard of Care|Patients assigned in this arm will receive standard of care following their kidney transplantation.
11117002|NCT01683331|BG002|Baseline|Total|Total of all reporting groups
11117003|NCT01683331|FG000|Participant Flow|Insulin Treatment for Hyperglycemia|NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG > 240, NPH initiation: 14, dose increases by 4; For pts. with CPG > 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG > 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG > 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG <60 mg/dl, NPH initiation: 0, ½ of previous dose.
11117004|NCT01683331|FG001|Participant Flow|Standard of Care|Patients assigned in this arm will receive standard of care following their kidney transplantation.
11117005|NCT01683331|OG000|Outcome|Insulin Treatment for Hyperglycemia|NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG > 240, NPH initiation: 14, dose increases by 4; For pts. with CPG > 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG > 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG > 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG <60 mg/dl, NPH initiation: 0, ½ of previous dose.
11117006|NCT01683331|OG001|Outcome|Standard of Care|Patients assigned in this arm will receive standard of care following their kidney transplantation.
11117007|NCT01683331|EG000|Reported Event|Insulin Treatment for Hyperglycemia|NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG > 240, NPH initiation: 14, dose increases by 4; For pts. with CPG > 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG > 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG > 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG <60 mg/dl, NPH initiation: 0, ½ of previous dose.
11117008|NCT01683331|EG001|Reported Event|Standard of Care|Patients assigned in this arm will receive standard of care following their kidney transplantation.
11117009|NCT01683383|BG000|Baseline|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
11117010|NCT01683383|BG001|Baseline|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
11117011|NCT01683383|BG002|Baseline|Total|Total of all reporting groups
11117012|NCT01683383|FG000|Participant Flow|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
11117013|NCT01683383|FG001|Participant Flow|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
11117014|NCT01683383|OG000|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
11117015|NCT01683383|OG001|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
11117016|NCT01683383|EG000|Reported Event|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
11117017|NCT01683383|EG001|Reported Event|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
11117018|NCT01683409|BG000|Baseline|Placebo|Placebo administered PO QD.
11117019|NCT01683409|BG001|Baseline|Baricitinib 0.75/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
11117020|NCT01683409|BG002|Baseline|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
11117021|NCT01683409|BG003|Baseline|Baricitinib 1.5 mg/1 mg QD|Baricitinib 1.5 mg or 1 mg administered PO QD.
11117022|NCT01683409|BG004|Baseline|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 administered PO QD.
11117023|NCT01683409|BG005|Baseline|Total|Total of all reporting groups
11117024|NCT01683409|FG000|Participant Flow|Placebo|Placebo administered orally (PO) once a day (QD).
11117025|NCT01683409|FG001|Participant Flow|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
11117026|NCT01683409|FG002|Participant Flow|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO twice a day (BID).
11117027|NCT01683409|FG003|Participant Flow|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
11117028|NCT01683409|FG004|Participant Flow|Baricitinib 4 mg/2.75 mg|Baricitinib 4 milligram (mg) or 2.75 mg administered PO QD.
11117029|NCT01683409|OG000|Outcome|Placebo|Placebo administered PO QD.
11117030|NCT01683409|OG001|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
11117031|NCT01683409|OG002|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
11117032|NCT01683409|OG003|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
11117033|NCT01683409|OG004|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
11117034|NCT01683409|OG000|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
11117035|NCT01683409|OG001|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
11117036|NCT01683409|OG002|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
11117037|NCT01683409|OG003|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
11117038|NCT01683409|EG000|Reported Event|Placebo|Placebo administered PO QD.
11117039|NCT01683409|EG001|Reported Event|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
11117040|NCT01683409|EG002|Reported Event|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
11117041|NCT01683409|EG003|Reported Event|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
11117042|NCT01683409|EG004|Reported Event|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
11117043|NCT01683409|EG005|Reported Event|Placebo - Washout 1|Placebo administered PO QD.
11117044|NCT01683409|EG006|Reported Event|Baricitinib 0.75 mg/0.5 mg QD - Washout 1|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
11117045|NCT01683409|EG007|Reported Event|Baricitinib 0.75 mg/0.5 mg BID - Washout 1|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
11117046|NCT01683409|EG008|Reported Event|Baricitinib 1.5 mg/1 mg - Washout 1|Baricitinib 1.5 mg or 1 mg administered PO QD.
11117047|NCT01683409|EG009|Reported Event|Baricitinib 4 mg/2.75 mg - Washout 1|Baricitinib 4 mg or 2.75 mg administered PO QD.
11117048|NCT01683409|EG010|Reported Event|Placebo Washout 2|Placebo administered PO QD.
11117049|NCT01683409|EG011|Reported Event|Baricitinib 0.75 mg/0.5 mg QD - Washout 2|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
11117050|NCT01683409|EG012|Reported Event|Baricitinib 0.75 mg/0.5 mg BID - Washout 2|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
11117051|NCT01683409|EG013|Reported Event|Baricitinib 1.5 mg/1 mg - Washout 2|Baricitinib 1.5 mg or 1 mg administered PO QD.
11117052|NCT01683409|EG014|Reported Event|Baricitinib 4 mg/2.75 mg - Washout 2|Baricitinib 4 mg or 2.75 mg administered PO QD.
11117053|NCT01683422|BG000|Baseline|Proton Radiation|"Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine Gemcitabine 1000 mg/m2 iv, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed.~Post-proton chemotherapy: To be started in 4 to 6 weeks after completion of proton chemotherapy. Oxaliplatin 130 mg/m2 po bid on days 2 to 15 for 14 days. The CapOx regimen (Capcitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles.~Radiation: Proton Radiation"
11117054|NCT01683422|FG000|Participant Flow|Proton Radiation|"Proton, Gemcitabine, Erlotinib, Capecitabine: Gemcitabine 1000 mg/m2 iv, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed.~Post-proton chemotherapy: To be started in 4 to 6 weeks after completion of proton chemotherapy. Oxaliplatin 130 mg/m2 po bid on days 2 to 15 for 14 days. The CapOx regimen (Capcitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles.~Proton Radiation"
11117055|NCT01683422|OG000|Outcome|Proton Radiation|"Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine Gemcitabine 1000 mg/m2 iv, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed.~Post-proton chemotherapy: To be started in 4 to 6 weeks after completion of proton chemotherapy. Oxaliplatin 130 mg/m2 po bid on days 2 to 15 for 14 days. The CapOx regimen (Capcitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles.~Radiation: Proton Radiation"
11117056|NCT01683422|EG000|Reported Event|Proton Radiation|"Gemcitabine 1000 mg/m2 iv, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed.~Post-proton chemotherapy: To be started in 4 to 6 weeks after completion of proton chemotherapy. Oxaliplatin 130 mg/m2 po bid on days 2 to 15 for 14 days. The CapOx regimen (Capcitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles."
11117057|NCT01683526|BG000|Baseline|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
11117058|NCT01683526|BG001|Baseline|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
11117059|NCT01683526|BG002|Baseline|Total|Total of all reporting groups
11117060|NCT01683526|FG000|Participant Flow|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
11117061|NCT01683526|FG001|Participant Flow|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
11117062|NCT01683526|OG000|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
11117063|NCT01683526|OG001|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
11117064|NCT01683526|EG000|Reported Event|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
11117065|NCT01683526|EG001|Reported Event|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
11117066|NCT01683565|BG000|Baseline|Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement|"Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA)~+ Gamma-Linolenic acid (GLA) + Oleic Acid (OA)~LCPUFA oil supplement: 2.5mL per day for 90 days~Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg"
11117067|NCT01683565|BG001|Baseline|Canola Oil Placebo|Canola Oil Placebo: 2.5mL per day for 90 days
11117068|NCT01683565|BG002|Baseline|Total|Total of all reporting groups
11117069|NCT01683565|FG000|Participant Flow|Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement|"Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA)~+ Gamma-Linolenic acid (GLA) + Oleic Acid (OA)~LCPUFA oil supplement: 2.5mL per day for 90 days~Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg"
11117070|NCT01683565|FG001|Participant Flow|Canola Oil Placebo|Canola Oil Placebo: 2.5mL per day for 90 days
11117071|NCT01683565|OG000|Outcome|Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement|"Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA)~+ Gamma-Linolenic acid (GLA) + Oleic Acid (OA)~LCPUFA oil supplement: 2.5mL per day for 90 days~Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg"
11117072|NCT01683565|OG001|Outcome|Canola Oil Placebo|Canola Oil Placebo: 2.5mL per day for 90 days
11117073|NCT01683565|OG000|Outcome|Long Chain Polyunsaturated Fatty Acids (LCPUFA) Supplement|"Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA)~+ Gamma-Linolenic acid (GLA) + Oleic Acid (OA)~LCPUFA oil supplement: 2.5mL per day for 90 days~Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)"
11117074|NCT01683565|OG000|Outcome|LCPUFA Oil Supplement|"EPA + DHA + GLA + OA oil supplement~LCPUFA oil supplement: 2.5mL per day for 90 days~Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)"
11117075|NCT01683565|EG000|Reported Event|LCPUFA Oil Supplement|"EPA + DHA + GLA + OA oil supplement~LCPUFA oil supplement: 2.5mL per day for 90 days~Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)"
11117076|NCT01683565|EG001|Reported Event|Canola Oil Placebo|Canola Oil Placebo: 2.5mL per day for 90 days
11117077|NCT01683604|BG000|Baseline|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
11117078|NCT01683604|FG000|Participant Flow|Rheumatoid Arthritis (RA) Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
11117079|NCT01683604|OG000|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
11117080|NCT01683604|OG001|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
11117081|NCT01683604|OG002|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
11117082|NCT01683604|OG003|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
11117083|NCT01683604|OG004|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
11117084|NCT01683604|OG003|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
11117085|NCT01683604|EG000|Reported Event|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
11117086|NCT01683630|BG000|Baseline|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
11117087|NCT01683630|BG001|Baseline|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
11117088|NCT01683630|BG002|Baseline|Total|Total of all reporting groups
11117089|NCT01683630|FG000|Participant Flow|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
11117090|NCT01683630|FG001|Participant Flow|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
11117091|NCT01683630|OG000|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
11117092|NCT01683630|OG001|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
11117093|NCT01683630|EG000|Reported Event|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
11117094|NCT01683630|EG001|Reported Event|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
11117095|NCT01683812|BG000|Baseline|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
11117096|NCT01683812|FG000|Participant Flow|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
11117097|NCT01683812|OG000|Outcome|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
11117098|NCT01683812|EG000|Reported Event|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
11117099|NCT01683838|BG000|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
11117100|NCT01683838|BG001|Baseline|Placebo|Placebo : Placebo
11117101|NCT01683838|BG002|Baseline|Total|Total of all reporting groups
11117102|NCT01683838|FG000|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
11117103|NCT01683838|FG001|Participant Flow|Placebo|Placebo : Placebo
11117104|NCT01683838|OG000|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
11117105|NCT01683838|OG001|Outcome|Placebo|Placebo : Placebo
11117106|NCT01683838|EG000|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
11117107|NCT01683838|EG001|Reported Event|Placebo|Placebo : Placebo
11117108|NCT01683994|BG000|Baseline|Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117109|NCT01683994|BG001|Baseline|Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117110|NCT01683994|BG002|Baseline|Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117111|NCT01683994|BG003|Baseline|Ph II Arm A: Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID)
11117112|NCT01683994|BG004|Baseline|Ph II Arm B: Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD)
11117113|NCT01683994|BG005|Baseline|Total|Total of all reporting groups
11117114|NCT01683994|FG000|Participant Flow|Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117115|NCT01683994|FG001|Participant Flow|Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117116|NCT01683994|FG002|Participant Flow|Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117117|NCT01683994|FG003|Participant Flow|Ph II Arm A: Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID)
11117118|NCT01683994|FG004|Participant Flow|Ph II Arm B: Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD)
11117119|NCT01683994|OG000|Outcome|Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117120|NCT01683994|OG001|Outcome|Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117121|NCT01683994|OG002|Outcome|Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117122|NCT01683994|OG003|Outcome|Ph II Arm A: Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID)
11117123|NCT01683994|OG004|Outcome|Ph II Arm B: Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD)
11117124|NCT01683994|OG000|Outcome|Ph I Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 20 mg, 40mg, and 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117125|NCT01683994|OG000|Outcome|Ph I Dose Level 1: Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 20mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117126|NCT01683994|OG001|Outcome|Ph I Dose Level 2: Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 40mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117127|NCT01683994|OG002|Outcome|Ph I Dose Level 3: Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 60mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117128|NCT01683994|OG003|Outcome|Ph II Arm A Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID)
11117129|NCT01683994|OG004|Outcome|Ph II Arm B: Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID); Cabozantinib: 40mg by mouth (PO) everyday (QD)
11117130|NCT01683994|EG000|Reported Event|Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117131|NCT01683994|EG001|Reported Event|Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117132|NCT01683994|EG002|Reported Event|Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
11117133|NCT01683994|EG003|Reported Event|Ph II Arm A: Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID)
11117134|NCT01683994|EG004|Reported Event|Ph II Arm B: Cabozantinib + Docetaxel + Prednisone|Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD)
11117135|NCT01684007|BG000|Baseline|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
11117136|NCT01684007|BG001|Baseline|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
11117137|NCT01684007|BG002|Baseline|Total|Total of all reporting groups
11117138|NCT01684007|FG000|Participant Flow|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
11117139|NCT01684007|FG001|Participant Flow|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
11117140|NCT01684007|OG000|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
11117141|NCT01684007|OG001|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
11117142|NCT01684007|EG000|Reported Event|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
11117143|NCT01684007|EG001|Reported Event|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
11117144|NCT01684020|BG000|Baseline|ARTISS Human Fibrin Sealant|"Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.~ARTISS human fibrin sealant"
11117145|NCT01684020|BG001|Baseline|Standard of Care|Fixation of the skin flap created during external rhinoplasty will use the standard of care
11117146|NCT01684020|BG002|Baseline|Total|Total of all reporting groups
11117147|NCT01684020|FG000|Participant Flow|ARTISS Human Fibrin Sealant|"Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.~ARTISS human fibrin sealant"
11117148|NCT01684020|FG001|Participant Flow|Standard of Care|Fixation of the skin flap created during external rhinoplasty will use the standard of care
11117149|NCT01684020|OG000|Outcome|ARTISS Human Fibrin Sealant|"Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.~ARTISS human fibrin sealant"
11117150|NCT01684020|OG001|Outcome|Standard of Care|Fixation of the skin flap created during external rhinoplasty will use the standard of care
11117151|NCT01684020|EG000|Reported Event|ARTISS Human Fibrin Sealant|"Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.~ARTISS human fibrin sealant"
11117152|NCT01684020|EG001|Reported Event|Standard of Care|Fixation of the skin flap created during external rhinoplasty will use the standard of care
11117153|NCT01684033|BG000|Baseline|PureMoist / Biotrue|Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.
11117154|NCT01684033|FG000|Participant Flow|PureMoist - Biotrue|Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
11117155|NCT01684033|FG001|Participant Flow|Biotrue - PureMoist|Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
11117156|NCT01684033|OG000|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
11117157|NCT01684033|OG001|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
11117158|NCT01684033|EG000|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
11117159|NCT01684033|EG001|Reported Event|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
11117160|NCT01684046|BG000|Baseline|PureMoist / RevitaLens|Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment.
11117161|NCT01684046|FG000|Participant Flow|PureMoist - RevitaLens|Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
11117162|NCT01684046|FG001|Participant Flow|RevitaLens - PureMoist|RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
11117163|NCT01684046|OG000|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
11117164|NCT01684046|OG001|Outcome|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
11117165|NCT01684046|EG000|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
11117166|NCT01684046|EG001|Reported Event|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
11117167|NCT01684202|BG000|Baseline|OPC-41061 3.75 mg|Orally administered at 3.75 mg once daily in maintenance period.
11117168|NCT01684202|BG001|Baseline|OPC-41061 7.5 mg|Orally administered at 7.5 mg once daily in maintenance period.
11117169|NCT01684202|BG002|Baseline|OPC-41061 15 mg|Orally administered at 15 mg once daily in maintenance period.
11117170|NCT01684202|BG003|Baseline|OPC-41061 30 mg|Orally administered at 30 mg once daily in maintenance period.
11117171|NCT01684202|BG004|Baseline|Total|Total of all reporting groups
11117172|NCT01684202|FG000|Participant Flow|OPC-41061 3.75 mg|Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
11117173|NCT01684202|FG001|Participant Flow|OPC-41061 7.5 mg|Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
11117174|NCT01684202|FG002|Participant Flow|OPC-41061 15 mg|Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
11117175|NCT01684202|FG003|Participant Flow|OPC-41061 30 mg|Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
11117176|NCT01684202|OG000|Outcome|OPC-41061 3.75 mg|Orally administered at 3.75 mg once daily in maintenance period.
11117177|NCT01684202|OG001|Outcome|OPC-41061 7.5 mg|Orally administered at 7.5 mg once daily in maintenance period.
11117178|NCT01684202|OG002|Outcome|OPC-41061 15 mg|Orally administered at 15 mg once daily in maintenance period.
11117179|NCT01684202|OG003|Outcome|OPC-41061 30 mg|Orally administered at 30 mg once daily in maintenance period.
11117180|NCT01684202|EG000|Reported Event|OPC-41061 3.75 mg|Orally administered at 3.75 mg once daily in maintenance period.
11117181|NCT01684202|EG001|Reported Event|OPC-41061 7.5 mg|Orally administered at 7.5 mg once daily in maintenance period.
11117182|NCT01684202|EG002|Reported Event|OPC-41061 15 mg|Orally administered at 15 mg once daily in maintenance period.
11117183|NCT01684202|EG003|Reported Event|OPC-41061 30 mg|Orally administered at 30 mg once daily in maintenance period.
11117184|NCT01684215|BG000|Baseline|PD-0332991 100 mg: Dose Escalation Cohort|In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11007905|NCT01093599|FG000|Participant Flow|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
11007906|NCT01093599|FG001|Participant Flow|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
11007907|NCT01093599|OG000|Outcome|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
11007908|NCT01093599|OG001|Outcome|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
11007909|NCT01093599|EG000|Reported Event|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
11007910|NCT01093599|EG001|Reported Event|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
11007911|NCT01093625|BG000|Baseline|Investigational Silicone Hydrogel Contact Lens|Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group.
11007912|NCT01093625|BG001|Baseline|Spectacles|Subjects are randomized to this Control Group.
11007913|NCT01093625|BG002|Baseline|Total|Total of all reporting groups
11007914|NCT01093625|FG000|Participant Flow|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
11007915|NCT01093625|FG001|Participant Flow|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
11007916|NCT01093625|OG000|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
11007917|NCT01093625|OG001|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
11007918|NCT01093625|EG000|Reported Event|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
11007919|NCT01093625|EG001|Reported Event|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
11007920|NCT01093651|BG000|Baseline|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
11007921|NCT01093651|BG001|Baseline|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
11007922|NCT01093651|BG002|Baseline|Total|Total of all reporting groups
11007923|NCT01093651|FG000|Participant Flow|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
11007924|NCT01093651|FG001|Participant Flow|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
11007925|NCT01093651|OG000|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
11007926|NCT01093651|OG001|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
11007927|NCT01093651|EG000|Reported Event|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
11007928|NCT01093651|EG001|Reported Event|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
11007929|NCT01093690|BG000|Baseline|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
11007930|NCT01093690|BG001|Baseline|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
11007931|NCT01093690|BG002|Baseline|Total|Total of all reporting groups
11117185|NCT01684215|BG001|Baseline|PD-0332991 125 mg: Dose Escalation Cohort|In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117186|NCT01684215|BG002|Baseline|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|In Phase1-Part 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117187|NCT01684215|BG003|Baseline|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|In Phase 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117188|NCT01684215|BG004|Baseline|Total|Total of all reporting groups
11117189|NCT01684215|FG000|Participant Flow|PD-0332991 100 mg: Dose Escalation Cohort|In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117190|NCT01684215|FG001|Participant Flow|PD-0332991 125 mg: Dose Escalation Cohort|In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117191|NCT01684215|FG002|Participant Flow|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|In Phase1-Part 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117192|NCT01684215|FG003|Participant Flow|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|In Phase 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117193|NCT01684215|OG000|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117194|NCT01684215|OG001|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117195|NCT01684215|OG000|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|In Phase1-Part 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117196|NCT01684215|OG000|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|In Phase 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117197|NCT01684215|OG002|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|In Phase 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117198|NCT01684215|OG002|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|In Phase1-Part 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117199|NCT01684215|OG003|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|In Phase 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117200|NCT01684215|EG000|Reported Event|PD-0332991 100 mg: Dose Escalation Cohort|In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117201|NCT01684215|EG001|Reported Event|PD-0332991 125 mg: Dose Escalation Cohort|In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117202|NCT01684215|EG002|Reported Event|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|In Phase1-Part 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117203|NCT01684215|EG003|Reported Event|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|In Phase 2, participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
11117204|NCT01684410|BG000|Baseline|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
11117205|NCT01684410|BG001|Baseline|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
11117206|NCT01684410|BG002|Baseline|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
11117207|NCT01684410|BG003|Baseline|Total|Total of all reporting groups
11117208|NCT01684410|FG000|Participant Flow|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
11117209|NCT01684410|FG001|Participant Flow|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
11117210|NCT01684410|FG002|Participant Flow|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
11117211|NCT01684410|OG000|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
11117212|NCT01684410|OG001|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
11117213|NCT01684410|OG002|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
11117214|NCT01684410|EG000|Reported Event|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
11117215|NCT01684410|EG001|Reported Event|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
11117216|NCT01684410|EG002|Reported Event|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
11117217|NCT01684423|BG000|Baseline|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
11117218|NCT01684423|BG001|Baseline|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
11117219|NCT01684423|BG002|Baseline|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
11117220|NCT01684423|BG003|Baseline|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
11117221|NCT01684423|BG004|Baseline|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
11117222|NCT01684423|BG005|Baseline|Total|Total of all reporting groups
11117223|NCT01684423|FG000|Participant Flow|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
11117224|NCT01684423|FG001|Participant Flow|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
11117225|NCT01684423|FG002|Participant Flow|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
11117226|NCT01684423|FG003|Participant Flow|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
11117227|NCT01684423|FG004|Participant Flow|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
11117228|NCT01684423|OG000|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
11117229|NCT01684423|OG001|Outcome|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
11117230|NCT01684423|OG002|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
11117231|NCT01684423|OG003|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
11117232|NCT01684423|OG004|Outcome|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
11117233|NCT01684423|OG001|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
11117234|NCT01684423|OG002|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
11117235|NCT01684423|EG000|Reported Event|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
11117236|NCT01684423|EG001|Reported Event|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
11117237|NCT01684423|EG002|Reported Event|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
11117238|NCT01684423|EG003|Reported Event|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
11117239|NCT01684423|EG004|Reported Event|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
11117240|NCT01684436|BG000|Baseline|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
11117241|NCT01684436|FG000|Participant Flow|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
11117242|NCT01684436|OG000|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
11117243|NCT01684436|EG000|Reported Event|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
11117244|NCT01684566|BG000|Baseline|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
11117245|NCT01684566|BG001|Baseline|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
11117246|NCT01684566|BG002|Baseline|Total|Total of all reporting groups
11117247|NCT01684566|FG000|Participant Flow|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
11117248|NCT01684566|FG001|Participant Flow|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
11117249|NCT01684566|OG000|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
11117250|NCT01684566|OG001|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
11117251|NCT01684566|EG000|Reported Event|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
11117252|NCT01684566|EG001|Reported Event|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
11117253|NCT01684592|BG000|Baseline|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
11117254|NCT01684592|BG001|Baseline|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
11117255|NCT01684592|BG002|Baseline|Total|Total of all reporting groups
11117256|NCT01684592|FG000|Participant Flow|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from Maryland Women's Clinic (MWC) during pregnancy. The 5 A's brief intervention was modified by the American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
11117257|NCT01684592|FG001|Participant Flow|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
11117258|NCT01684592|OG000|Outcome|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
11117259|NCT01684592|OG001|Outcome|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
11117260|NCT01684592|EG000|Reported Event|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
11117261|NCT01684592|EG001|Reported Event|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
11117262|NCT01684748|BG000|Baseline|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.~Olmesartan medoxomil"
11348352|NCT04179461|FG000|Participant Flow|Personalized Treatment|"Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.~Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.~Cholecalciferol: Oral administration~antihistamine: Oral administration~Azithromycin: Oral administration~emollient cream: Topical~Fluticasone Propionate: Nasal spray~Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."
11117263|NCT01684748|BG001|Baseline|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
11117264|NCT01684748|BG002|Baseline|Total|Total of all reporting groups
11117265|NCT01684748|FG000|Participant Flow|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.~Olmesartan medoxomil"
11117266|NCT01684748|FG001|Participant Flow|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
11117267|NCT01684748|OG000|Outcome|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
11117268|NCT01684748|OG001|Outcome|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
11117269|NCT01684748|EG000|Reported Event|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
11117270|NCT01684748|EG001|Reported Event|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
11117271|NCT01684839|BG000|Baseline|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
11117272|NCT01684839|FG000|Participant Flow|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
11117273|NCT01684839|OG000|Outcome|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
11117274|NCT01684839|EG000|Reported Event|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
11117275|NCT01684878|BG000|Baseline|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
11117276|NCT01684878|BG001|Baseline|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
11117277|NCT01684878|BG002|Baseline|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
11117278|NCT01684878|BG003|Baseline|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
11117279|NCT01684878|BG004|Baseline|Total|Total of all reporting groups
11117280|NCT01684878|FG000|Participant Flow|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
11117281|NCT01684878|FG001|Participant Flow|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
11117282|NCT01684878|FG002|Participant Flow|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
11117283|NCT01684878|FG003|Participant Flow|Part 2: Placebo+Chemotherapy|Participants received pertuzumab-matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
11117284|NCT01684878|OG000|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
11117285|NCT01684878|OG001|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
11117286|NCT01684878|OG000|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
11117287|NCT01684878|OG001|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
11117288|NCT01684878|EG000|Reported Event|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
11117289|NCT01684878|EG001|Reported Event|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
11117290|NCT01684878|EG002|Reported Event|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
11117291|NCT01684878|EG003|Reported Event|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
11117292|NCT01684917|BG000|Baseline|Exercise|"An overweight/dysglycemic group~4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks"
11117293|NCT01684917|BG001|Baseline|Diet|overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks
11117294|NCT01684917|BG002|Baseline|Exercise, Control|An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
11117295|NCT01684917|BG003|Baseline|Diet, Control|overweight/ obese subjects with normal glucose metabolism for 12 weeks
11117296|NCT01684917|BG004|Baseline|Total|Total of all reporting groups
11117297|NCT01684917|FG000|Participant Flow|Exercise|"An overweight/dysglycemic group~4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks"
11117298|NCT01684917|FG001|Participant Flow|Diet|"overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks.~Energy intake was matched with estimated energy expenditure"
11117299|NCT01684917|FG002|Participant Flow|Exercise, Control|An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
11117300|NCT01684917|FG003|Participant Flow|Diet, Control|"overweight/ obese subjects with normal glucose metabolism for 12 weeks~Energy intake was matched with estimated energy expenditure"
11117301|NCT01684917|OG000|Outcome|Exercise|"An overweight/dysglycemic group~4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks"
11117302|NCT01684917|OG001|Outcome|Diet|overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks
11117303|NCT01684917|OG002|Outcome|Exercise, Control|An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
11117304|NCT01684917|OG003|Outcome|Diet, Control|overweight/ obese subjects with normal glucose metabolism for 12 weeks
11117305|NCT01684917|EG000|Reported Event|Exercise|"An overweight/dysglycemic group~4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks"
11117306|NCT01684917|EG001|Reported Event|Diet|overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks
11117307|NCT01684917|EG002|Reported Event|Exercise, Control|An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
11117308|NCT01684917|EG003|Reported Event|Diet, Control|overweight/ obese subjects with normal glucose metabolism for 12 weeks
11117309|NCT01684930|BG000|Baseline|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
11126781|NCT01735617|BG000|Baseline|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
11117310|NCT01684930|BG001|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
11117311|NCT01684930|BG002|Baseline|Total|Total of all reporting groups
11117312|NCT01684930|FG000|Participant Flow|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
11117313|NCT01684930|FG001|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
11117314|NCT01684930|OG000|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
11117315|NCT01684930|OG001|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
11117316|NCT01684930|EG000|Reported Event|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
11117317|NCT01684930|EG001|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
11117318|NCT01684943|BG000|Baseline|Multiplex Pharmacokinetic Profiling|"Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin~Multiplex pharmacokinetic profiling"
11117319|NCT01684943|BG001|Baseline|Continuous Insulin Monitoring|"Continuous insulin monitoring of insulin lispro~Continuous insulin monitoring"
11117320|NCT01684943|BG002|Baseline|Multiplex PK Profiling and Continuous Insulin Monitoring|Participated in both study phases, the multiplex PK profiling visits and the CIM visits
11117321|NCT01684943|BG003|Baseline|Total|Total of all reporting groups
11117322|NCT01684943|FG000|Participant Flow|Multiplex Pharmacokinetic (PK) Profiling|"Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin~Multiplex pharmacokinetic profiling"
11117323|NCT01684943|FG001|Participant Flow|Continuous Insulin Monitoring (CIM)|"Continuous insulin monitoring of insulin lispro~Continuous insulin monitoring"
11117324|NCT01684943|FG002|Participant Flow|Multiplex PK Profiling and Continuous Insulin Monitoring|Subjects that participated in both the multiplex PK profiling experiments and the continuous insulin monitoring experiments
11117325|NCT01684943|OG000|Outcome|All Participants|All participants who completed the MultiPK visits
11117326|NCT01684943|OG000|Outcome|Experiment #3|This includes the data from experiment #3. Only 2 of the 4 experiments conducted under the Continuous Insulin Monitoring sub-study protocol produced usable data for analysis. Those two experiments are both reported here.
11117327|NCT01684943|OG001|Outcome|Experiment #4|This includes the data from experiment #4. Only 2 of the 4 experiments conducted under the Continuous Insulin Monitoring sub-study protocol produced usable data for analysis. Those two experiments are both reported here.
11117328|NCT01684943|OG000|Outcome|Participants Using the Faster Insulin|Participants who were using the insulin analog at baseline that we determined had a faster tmax for this individual
11117329|NCT01684943|OG001|Outcome|Participants Using the Slower Insulin|Participants who were using the insulin analog at baseline that we determined had a slower tmax for this individual
11117330|NCT01684943|OG002|Outcome|Participants Where the Two Insulins Were the Same|Participants who we determined had no difference in the tmax between the two analogs
11117331|NCT01684943|OG000|Outcome|Subjects Using Insulin With a Tmax < 60 Minutes|Participants who were using the insulin analog at baseline that we determined had a tmax of less than 60 minutes for this individual.
11117332|NCT01684943|OG001|Outcome|Subjects Using Insulin With a Tmax of > 60 Minutes|Participants who were using the insulin analog at baseline that we determined had a tmax of more than 60 minutes for this individual.
11117333|NCT01684943|EG000|Reported Event|Multiplex Pharmacokinetic Profiling Only|"Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin. This only includes subjects that participated in the Multiplex PK profiling part of the protocol and not the continuous insulin monitoring part of the protocol.~Multiplex pharmacokinetic profiling"
11117334|NCT01684943|EG001|Reported Event|Continuous Insulin Monitoring Only|"Continuous insulin monitoring of insulin lispro. This only includes subjects that participated in the continuous insulin monitoring part of the protocol and did not participate in the Multiplex PK profiling part of the protocol.~Continuous insulin monitoring"
11117335|NCT01684943|EG002|Reported Event|Both Multiplex PK and Continuous Insulin Monitoring|Participants that enrolled and completed both parts of the trial.
11117336|NCT01685021|BG000|Baseline|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)"
11117337|NCT01685021|FG000|Participant Flow|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
11117338|NCT01685021|OG000|Outcome|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
11117339|NCT01685021|EG000|Reported Event|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
11117340|NCT01685047|BG000|Baseline|Patient Population|Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
11117341|NCT01685047|FG000|Participant Flow|Patient Population|Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
11117342|NCT01685047|OG000|Outcome|Patient Population|Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
11117343|NCT01685047|EG000|Reported Event|Patient Population|Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
11117344|NCT01685060|BG000|Baseline|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
11117345|NCT01685060|FG000|Participant Flow|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
11117346|NCT01685060|OG000|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
11117347|NCT01685060|EG000|Reported Event|LDK378 750 mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
11117348|NCT01685073|BG000|Baseline|Zolpidem|"Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder~Zolpidem extended-release: nightly administration of zolpidem extended-release~MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants"
11117349|NCT01685073|BG001|Baseline|Placebo|"Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder~MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants"
11117350|NCT01685073|BG002|Baseline|Total|Total of all reporting groups
11117351|NCT01685073|FG000|Participant Flow|Zolpidem|"Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder~Zolpidem extended-release: nightly administration of zolpidem extended-release~MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants"
11117352|NCT01685073|FG001|Participant Flow|Placebo|"Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder~MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants"
11117353|NCT01685073|OG000|Outcome|Zolpidem|"Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder~Zolpidem extended-release: nightly administration of zolpidem extended-release~MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants"
11117354|NCT01685073|OG001|Outcome|Placebo|"Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder~MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants"
11117355|NCT01685073|EG000|Reported Event|Zolpidem|"Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder~Zolpidem extended-release: nightly administration of zolpidem extended-release~MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants"
11117356|NCT01685073|EG001|Reported Event|Placebo|"Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder~MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants"
11117357|NCT01685138|BG000|Baseline|LDK378 (Ceritinib)|Participants on this arm took oral LDK378 750 mg once daily.
11117358|NCT01685138|FG000|Participant Flow|LDK378 (Ceritinib)|Participants on this arm took oral LDK378 750 mg once daily.
11117359|NCT01685138|OG000|Outcome|LDK378 (Ceritinib)|Participants on this arm took oral LDK378 750 mg once daily.
11117360|NCT01685138|EG000|Reported Event|LDK378 Ceritinib)|Participants on this arm took oral LDK378 750 mg once daily.
11117361|NCT01685203|BG000|Baseline|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
11117362|NCT01685203|BG001|Baseline|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
11117363|NCT01685203|BG002|Baseline|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
11117364|NCT01685203|BG003|Baseline|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
11117365|NCT01685203|BG004|Baseline|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
11117366|NCT01685203|BG005|Baseline|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
11117367|NCT01685203|BG006|Baseline|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
11117368|NCT01685203|BG007|Baseline|Total|Total of all reporting groups
11117369|NCT01685203|FG000|Participant Flow|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
11117370|NCT01685203|FG001|Participant Flow|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
11117371|NCT01685203|FG002|Participant Flow|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
11117372|NCT01685203|FG003|Participant Flow|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
11117373|NCT01685203|FG004|Participant Flow|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
11117374|NCT01685203|FG005|Participant Flow|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
11117375|NCT01685203|FG006|Participant Flow|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
11117376|NCT01685203|OG000|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
11117377|NCT01685203|OG001|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
11117378|NCT01685203|OG002|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
11117379|NCT01685203|OG003|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
11117380|NCT01685203|OG004|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
11117381|NCT01685203|OG005|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
11117382|NCT01685203|OG006|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
11117383|NCT01685203|EG000|Reported Event|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
11117384|NCT01685203|EG001|Reported Event|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
11117385|NCT01685203|EG002|Reported Event|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
11117386|NCT01685203|EG003|Reported Event|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
11117387|NCT01685203|EG004|Reported Event|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants
11117388|NCT01685203|EG005|Reported Event|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
11117389|NCT01685203|EG006|Reported Event|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
11117390|NCT01685216|BG000|Baseline|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
11117391|NCT01685216|FG000|Participant Flow|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
11117392|NCT01685216|OG000|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
11117393|NCT01685216|EG000|Reported Event|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
11117394|NCT01685229|BG000|Baseline|Balloon Sinus Dilation|Subjects with chronic sinusitis electing to have a balloon sinus dilation
11117395|NCT01685229|BG001|Baseline|Medical Management|Subjects with chronic sinusitis electing to continue medical therapy
11117396|NCT01685229|BG002|Baseline|Total|Total of all reporting groups
11117397|NCT01685229|FG000|Participant Flow|Balloon Sinus Dilation|Subjects with chronic sinusitis electing to have a balloon sinus dilation
11117398|NCT01685229|FG001|Participant Flow|Medical Management|Subjects with chronic sinusitis electing to continue medical therapy
11117399|NCT01685229|OG000|Outcome|Balloon Sinus Dilation|Subjects with chronic sinusitis electing to have a balloon sinus dilation
11117400|NCT01685229|OG001|Outcome|Medical Management|Subjects with chronic sinusitis electing to continue medical therapy
11117401|NCT01685229|OG000|Outcome|Medical Management|Subjects with chronic sinusitis electing to continue medical therapy
11117402|NCT01685229|OG001|Outcome|In-Office|BSD subjects treated in an office setting
11117403|NCT01685229|OG002|Outcome|Operating Room|BSD subjects treating in an Operating Room venue
11117404|NCT01685229|EG000|Reported Event|Balloon Sinus Dilation|Subjects with chronic sinusitis electing to have a balloon sinus dilation
11117405|NCT01685229|EG001|Reported Event|Medical Management|Subjects with chronic sinusitis electing to continue medical therapy
11117406|NCT01685242|BG000|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11117407|NCT01685242|BG001|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11117408|NCT01685242|BG002|Baseline|Total|Total of all reporting groups
11117409|NCT01685242|FG000|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11117410|NCT01685242|FG001|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11117411|NCT01685242|OG000|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11117412|NCT01685242|OG001|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11117413|NCT01685242|EG000|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11117414|NCT01685242|EG001|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11117415|NCT01685320|BG000|Baseline|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
11117416|NCT01685320|BG001|Baseline|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
11117417|NCT01685320|BG002|Baseline|Total|Total of all reporting groups
11117418|NCT01685320|FG000|Participant Flow|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
11117419|NCT01685320|FG001|Participant Flow|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
11117420|NCT01685320|OG000|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
11117421|NCT01685320|OG001|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
11117422|NCT01685320|EG000|Reported Event|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
11117423|NCT01685320|EG001|Reported Event|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
11117424|NCT01685372|BG000|Baseline|Fluzone High Dose|"Fluzone High Dose 0.5 mL intramuscularly (IM) given once~Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm"
11117425|NCT01685372|BG001|Baseline|Fluzone Standard Dose|"Fluzone 0.5mL IM given once~Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm"
11117426|NCT01685372|BG002|Baseline|Total|Total of all reporting groups
11117427|NCT01685372|FG000|Participant Flow|Fluzone High Dose|A single-dose of high-dose influenza vaccine was administered to subjects randomized to this arm at T1
11117428|NCT01685372|FG001|Participant Flow|Fluzone Standard Dose|A single-dose of standard-dose influenza vaccine was administered to subjects randomized to this arm at T1
11117429|NCT01685372|OG000|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
11117430|NCT01685372|OG001|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
11117431|NCT01685372|EG000|Reported Event|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
11117432|NCT01685372|EG001|Reported Event|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
11117433|NCT01685411|BG000|Baseline|Allogeneic Hematopoietic Stem Cell Transplant|Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion
11117434|NCT01685411|FG000|Participant Flow|Allogeneic Hematopoietic Stem Cell Transplant|Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
11117435|NCT01685411|OG000|Outcome|Allogeneic Hematopoietic Stem Cell Transplant|Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
11117436|NCT01685411|EG000|Reported Event|Allogeneic Hematopoietic Stem Cell Transplant|Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
11117437|NCT01685437|BG000|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
11117438|NCT01685437|FG000|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
11117439|NCT01685437|OG000|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
11117440|NCT01685437|EG000|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
11117441|NCT01685463|BG000|Baseline|Transcranial Magnetic Stimulation|"Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.~Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.~Electrical stimulation instead."
11117442|NCT01685463|BG001|Baseline|Sham Transcranial Magnetic Stimulation|"Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.~Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS."
11117443|NCT01685463|BG002|Baseline|Total|Total of all reporting groups
11117444|NCT01685463|FG000|Participant Flow|Transcranial Magnetic Stimulation|"Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.~Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.~Electrical stimulation instead."
11117445|NCT01685463|FG001|Participant Flow|Sham Transcranial Magnetic Stimulation|"Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.~Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS."
11117446|NCT01685463|OG000|Outcome|Transcranial Magnetic Stimulation|"Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.~Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.~Electrical stimulation instead."
11117447|NCT01685463|OG001|Outcome|Sham Transcranial Magnetic Stimulation|"Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.~Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS."
11117448|NCT01685463|EG000|Reported Event|Transcranial Magnetic Stimulation|"Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.~Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.~Electrical stimulation instead."
11117449|NCT01685463|EG001|Reported Event|Sham Transcranial Magnetic Stimulation|"Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.~Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS."
11117450|NCT01685567|BG000|Baseline|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
11117451|NCT01685567|FG000|Participant Flow|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
11117452|NCT01685567|OG000|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
11117453|NCT01685567|EG000|Reported Event|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
11117454|NCT01685684|BG000|Baseline|Oxycodone DETERx (Double-blind Maintenance Phase)|
11117455|NCT01685684|BG001|Baseline|Placebo (Double-blind Maintenance Phase)|
11117456|NCT01685684|BG002|Baseline|Total|Total of all reporting groups
11117457|NCT01685684|FG000|Participant Flow|Oxycodone DETERx (Titration Phase)|Achieve a stable Oxycodone DETERx dose of 40-160 mg total daily dose.
11117458|NCT01685684|FG001|Participant Flow|Oxycodone DETERx (Double-blind Maintenance Phase)|Oxycodone DETERx: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
11117459|NCT01685684|FG002|Participant Flow|Placebo (Double-blind Maintenance Phase)|Placebo: Placebo, divided into 2 doses, q12h
11117460|NCT01685684|OG000|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
11117461|NCT01685684|OG001|Outcome|Placebo (Double-blind Maintenance Phase)|
11117462|NCT01685684|EG000|Reported Event|Screening|Serious Adverse Event (SAE) collection started during screening.
11117463|NCT01685684|EG001|Reported Event|Oxycodone DETERx (Titration Phase)|
11117464|NCT01685684|EG002|Reported Event|Oxycodone DETERx (Double-blind Maintenance Phase)|
11117465|NCT01685684|EG003|Reported Event|Placebo (Double-blind Maintenance Phase)|
11117466|NCT01685697|BG000|Baseline|Laerdal Mask|"Mask ventilation with a Laerdal face mask~Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.~Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group."
11117467|NCT01685697|BG001|Baseline|F&P Mask|"Mask ventilation with a F&P face mask~Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.~Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group."
11117468|NCT01685697|BG002|Baseline|Total|Total of all reporting groups
11117469|NCT01685697|FG000|Participant Flow|Laerdal Mask|"Mask ventilation with a Laerdal face mask~Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.~Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group."
11117470|NCT01685697|FG001|Participant Flow|F&P Mask|"Mask ventilation with a F&P face mask~Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.~Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group."
11117471|NCT01685697|OG000|Outcome|Laerdal Mask|Potentially eligible infants were randomized immediately prior to delivery and then received PPV as clinically necessary with either the F&P ∅35mm or ∅42mm F&P mask.
11117472|NCT01685697|OG001|Outcome|F&P Mask|Potentially eligible infants were randomized immediately prior to delivery and then received PPV as clinically necessary with either the F&P ∅35mm or ∅42mm F&P mask.
11117473|NCT01685697|EG000|Reported Event|Laerdal Mask|"Mask ventilation with a Laerdal face mask~Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.~Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group."
11117474|NCT01685697|EG001|Reported Event|F&P Mask|"Mask ventilation with a F&P face mask~Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.~Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group."
11117475|NCT01685801|BG000|Baseline|IPIP|Detailed reporting group description is provided in Participant Flow module.
11117476|NCT01685801|BG001|Baseline|IPPI|Detailed reporting group description is provided in Participant Flow module.
11117477|NCT01685801|BG002|Baseline|PIIP|Detailed reporting group description is provided in Participant Flow module.
11117478|NCT01685801|BG003|Baseline|PIPI|Detailed reporting group description is provided in Participant Flow module.
11117479|NCT01685801|BG004|Baseline|Total|Total of all reporting groups
11117480|NCT01685801|FG000|Participant Flow|Ivacaftor, Placebo, Ivacaftor, Placebo (IPIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
11117481|NCT01685801|FG001|Participant Flow|Ivacaftor, Placebo, Placebo, Ivacaftor (IPPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
11117482|NCT01685801|FG002|Participant Flow|Placebo, Ivacaftor, Ivacaftor, Placebo (PIIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
11117483|NCT01685801|FG003|Participant Flow|Placebo, Ivacaftor, Placebo, Ivacaftor (PIPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
11117484|NCT01685801|OG000|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
11117485|NCT01685801|OG001|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
11117486|NCT01685801|OG002|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
11117487|NCT01685801|OG003|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
11117488|NCT01685801|OG001|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 1.
11117489|NCT01685801|OG003|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 2.
11117490|NCT01685801|OG000|Outcome|Open-Label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
11117491|NCT01685801|OG000|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours in open-label period (8 weeks) after washout period 2.
11117492|NCT01685801|OG000|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
11117493|NCT01685801|OG000|Outcome|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
11117494|NCT01685801|OG001|Outcome|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
11117495|NCT01685801|OG002|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
11117496|NCT01685801|EG000|Reported Event|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
11117497|NCT01685801|EG001|Reported Event|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
11117498|NCT01685801|EG002|Reported Event|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
11117499|NCT01685840|BG000|Baseline|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
11117500|NCT01685840|BG001|Baseline|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
11117501|NCT01685840|BG002|Baseline|Total|Total of all reporting groups
11117502|NCT01685840|FG000|Participant Flow|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
11117503|NCT01685840|FG001|Participant Flow|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
11117504|NCT01685840|OG000|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
11117505|NCT01685840|OG001|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
11117506|NCT01685840|OG000|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
11117507|NCT01685840|OG001|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
11117508|NCT01685840|EG000|Reported Event|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
11117509|NCT01685840|EG001|Reported Event|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
11117510|NCT01685983|BG000|Baseline|Abiraterone Acetate|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
11117511|NCT01685983|FG000|Participant Flow|Abiraterone Acetate|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
11117512|NCT01685983|OG000|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
11117513|NCT01685983|EG000|Reported Event|Abiraterone Acetate|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
11117514|NCT01685996|BG000|Baseline|Zonisamide|Participants receive zonisamide + varenicline for smoking cessation
11117515|NCT01685996|BG001|Baseline|Placebo|Participants receive placebo + varenicline for smoking cessation
11117516|NCT01685996|BG002|Baseline|Total|Total of all reporting groups
11117517|NCT01685996|FG000|Participant Flow|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
11117518|NCT01685996|FG001|Participant Flow|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
11117519|NCT01685996|OG000|Outcome|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
11117520|NCT01685996|OG001|Outcome|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
11117521|NCT01685996|EG000|Reported Event|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
11117522|NCT01685996|EG001|Reported Event|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
11117523|NCT01686152|BG000|Baseline|Investigational Test Product|Imiquimod Cream, 3.75% (Teva)
11117524|NCT01686152|BG001|Baseline|Reference Listed Drug|Zyclara® (imiquimod Cream), 3.75% (Medicis)
11117525|NCT01686152|BG002|Baseline|Vehicle|Vehicle of Test Product (Teva)
11117526|NCT01686152|BG003|Baseline|Total|Total of all reporting groups
11117527|NCT01686152|FG000|Participant Flow|Investigational Test Product|Imiquimod Cream, 3.75% (Teva)
11117528|NCT01686152|FG001|Participant Flow|Reference Listed Drug|Zyclara® (imiquimod Cream), 3.75% (Medicis)
11117529|NCT01686152|FG002|Participant Flow|Vehicle|Vehicle of Test Product (Teva)
11117530|NCT01686152|OG000|Outcome|Investigational Test Product|Imiquimod Cream, 3.75% (Teva)
11117531|NCT01686152|OG001|Outcome|Reference Listed Drug|Zyclara® (imiquimod Cream), 3.75% (Medicis)
11117532|NCT01686152|OG002|Outcome|Vehicle|Vehicle of Test Product (Teva)
11117533|NCT01686152|EG000|Reported Event|Investigational Test Product|Imiquimod Cream, 3.75% (Teva)
11117534|NCT01686152|EG001|Reported Event|Reference Listed Drug|Zyclara® (imiquimod Cream), 3.75% (Medicis)
11117535|NCT01686152|EG002|Reported Event|Vehicle|Vehicle of Test Product (Teva)
11117536|NCT01686165|BG000|Baseline|PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle|Treatment with PXD101 will be administered intravenously** at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
11117537|NCT01686165|FG000|Participant Flow|PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle|Treatment with PXD101 will be administered intravenously** at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
11117538|NCT01686165|OG000|Outcome|PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle|Treatment with PXD101 will be administered intravenously** at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
11117539|NCT01686165|EG000|Reported Event|PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle|Treatment with PXD101 will be administered intravenously** at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
11117540|NCT01686373|BG000|Baseline|Activa Dose II Real tDCS|"Actual delivery of electrical stimulation~Activa Dose II Real tDCS"
11117541|NCT01686373|BG001|Baseline|Activa Dose II Sham tDCS|"Sham delivery of electrical stimulation~Activa Dose II Sham tDCS"
11117542|NCT01686373|BG002|Baseline|Total|Total of all reporting groups
11117543|NCT01686373|FG000|Participant Flow|Activa Dose II Real tDCS|"Actual delivery of electrical stimulation~Activa Dose II Real tDCS"
11117544|NCT01686373|FG001|Participant Flow|Activa Dose II Sham tDCS|"Sham delivery of electrical stimulation~Activa Dose II Sham tDCS"
11117545|NCT01686373|OG000|Outcome|Activa Dose II Real tDCS|"Actual delivery of electrical stimulation~Activa Dose II Real tDCS"
11117546|NCT01686373|OG001|Outcome|Activa Dose II Sham tDCS|"Sham delivery of electrical stimulation~Activa Dose II Sham tDCS"
11117547|NCT01686373|EG000|Reported Event|Activa Dose II Real tDCS|"Actual delivery of electrical stimulation~Activa Dose II Real tDCS"
11117548|NCT01686373|EG001|Reported Event|Activa Dose II Sham tDCS|"Sham delivery of electrical stimulation~Activa Dose II Sham tDCS"
11117549|NCT01686438|BG000|Baseline|Control|Non-active intervention of sleep education delivered in-person
11117550|NCT01686438|BG001|Baseline|CBT-I In-person|Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
11117551|NCT01686438|BG002|Baseline|CBT-I Telehealth|Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
11117552|NCT01686438|BG003|Baseline|Total|Total of all reporting groups
11117553|NCT01686438|FG000|Participant Flow|Control|Non-active intervention of sleep education delivered in-person
11117554|NCT01686438|FG001|Participant Flow|CBT-I In-person|Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
11117555|NCT01686438|FG002|Participant Flow|CBT-I Telehealth|Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
11117556|NCT01686438|OG000|Outcome|CBT-I In-person|Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
11117557|NCT01686438|OG001|Outcome|CBT-I Telehealth|Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
11117558|NCT01686438|OG000|Outcome|Control|Non-active intervention of sleep education delivered in-person
11117559|NCT01686438|OG001|Outcome|CBT-I In-person|Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
11117560|NCT01686438|OG002|Outcome|CBT-I Telehealth|Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
11117561|NCT01686438|EG000|Reported Event|Control|Non-active intervention of sleep education delivered in-person
11117562|NCT01686438|EG001|Reported Event|CBT-I In-person|Cognitive behavior therapy for insomnia (CBT-I) delivered in-person
11117563|NCT01686438|EG002|Reported Event|CBT-I Telehealth|Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing
11117564|NCT01686451|BG000|Baseline|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
11117565|NCT01686451|BG001|Baseline|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
11117566|NCT01686451|BG002|Baseline|Total|Total of all reporting groups
11117567|NCT01686451|FG000|Participant Flow|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
11117568|NCT01686451|FG001|Participant Flow|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
11117569|NCT01686451|OG000|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
11117570|NCT01686451|OG001|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
11117571|NCT01686451|OG002|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
11117572|NCT01686451|OG003|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
11117573|NCT01686451|EG000|Reported Event|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
11117574|NCT01686451|EG001|Reported Event|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
11117575|NCT01686503|BG000|Baseline|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117576|NCT01686503|BG001|Baseline|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117577|NCT01686503|BG002|Baseline|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117578|NCT01686503|BG003|Baseline|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117579|NCT01686503|BG004|Baseline|Total|Total of all reporting groups
11117580|NCT01686503|FG000|Participant Flow|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117581|NCT01686503|FG001|Participant Flow|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117582|NCT01686503|FG002|Participant Flow|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117583|NCT01686503|FG003|Participant Flow|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117584|NCT01686503|OG000|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117585|NCT01686503|OG001|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117586|NCT01686503|OG002|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117587|NCT01686503|OG003|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117588|NCT01686503|EG000|Reported Event|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117589|NCT01686503|EG001|Reported Event|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117590|NCT01686503|EG002|Reported Event|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117591|NCT01686503|EG003|Reported Event|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
11117592|NCT01686568|BG000|Baseline|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
11117593|NCT01686568|BG001|Baseline|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
11117594|NCT01686568|BG002|Baseline|Total|Total of all reporting groups
11117595|NCT01686568|FG000|Participant Flow|Omega-3|Patients in this group will receive oral supplementation with EPA + Docosahexaenoic acid (DHA) (3.9grams/day) for 6 months.
11117596|NCT01686568|FG001|Participant Flow|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
11117597|NCT01686568|OG000|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
11117598|NCT01686568|OG001|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
11117599|NCT01686568|EG000|Reported Event|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
11117600|NCT01686568|EG001|Reported Event|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
11117601|NCT01686581|BG000|Baseline|BOTOX®|BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.
11117602|NCT01686581|FG000|Participant Flow|BOTOX®|BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.
11117603|NCT01686581|OG000|Outcome|BOTOX®|BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.
11117604|NCT01686581|EG000|Reported Event|BOTOX®|BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.
11117605|NCT01686633|BG000|Baseline|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117606|NCT01686633|BG001|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117607|NCT01686633|BG002|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117608|NCT01686633|BG003|Baseline|Total|Total of all reporting groups
11117609|NCT01686633|FG000|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder once daily (OD) in the evening from a dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117610|NCT01686633|FG001|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117611|NCT01686633|FG002|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117612|NCT01686633|OG000|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117613|NCT01686633|OG001|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117614|NCT01686633|OG002|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117615|NCT01686633|EG000|Reported Event|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117616|NCT01686633|EG001|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117617|NCT01686633|EG002|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11117618|NCT01686646|BG000|Baseline|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
11117619|NCT01686646|BG001|Baseline|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
11117620|NCT01686646|BG002|Baseline|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
11117621|NCT01686646|BG003|Baseline|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
11117622|NCT01686646|BG004|Baseline|Total|Total of all reporting groups
11117623|NCT01686646|FG000|Participant Flow|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 milligrams [mg] ) and caffeine (65 mg) tablets were dissolved in 200 milliliter (mL) of water and administered orally.
11117624|NCT01686646|FG001|Participant Flow|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
11117625|NCT01686646|FG002|Participant Flow|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
11117626|NCT01686646|FG003|Participant Flow|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
11117627|NCT01686646|OG000|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
11117628|NCT01686646|OG001|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
11117629|NCT01686646|OG002|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
11117630|NCT01686646|OG003|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
11117631|NCT01686646|EG000|Reported Event|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
11117632|NCT01686646|EG001|Reported Event|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
11117633|NCT01686646|EG002|Reported Event|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
11117634|NCT01686646|EG003|Reported Event|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
11117635|NCT01686750|BG000|Baseline|Integrated Care Centers|"Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.~HIV voluntary counseling and testing & staging~Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy~Substance abuse counseling~Sexually transmitted infection screening and treatment~Access to free antiretroviral therapy and adherence support~Peer community outreach"
11117636|NCT01686750|BG001|Baseline|Standard Services|In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
11117637|NCT01686750|BG002|Baseline|Total|Total of all reporting groups
11117638|NCT01686750|FG000|Participant Flow|Integrated Care Centers|"Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.~HIV voluntary counseling and testing & staging~Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy~Substance abuse counseling~Sexually transmitted infection screening and treatment~Access to free antiretroviral therapy and adherence support~Peer community outreach"
11117639|NCT01686750|FG001|Participant Flow|Standard Services|In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
11117640|NCT01686750|OG000|Outcome|Integrated Care Centers|"Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.~HIV voluntary counseling and testing & staging~Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy~Substance abuse counseling~Sexually transmitted infection screening and treatment~Access to free antiretroviral therapy and adherence support~Peer community outreach"
11117641|NCT01686750|OG001|Outcome|Standard Services|In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
11117642|NCT01686750|OG000|Outcome|Integrated Care Centers|"Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.~HIV voluntary counseling and testing & staging~Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy~Substance abuse counseling~Sexually transmitted infection screening and treatment~Access to free antiretroviral therapy and adherence support~Peer community outreach~Integrated care centers"
11005525|NCT01080807|EG001|Reported Event|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
11005526|NCT01080976|BG000|Baseline|Primary Care Physicians|
11005527|NCT01080976|BG001|Baseline|Diabetologists|
11005528|NCT01080976|BG002|Baseline|Total|Total of all reporting groups
11005529|NCT01080976|FG000|Participant Flow|Primary Care Physicians|
11005530|NCT01080976|FG001|Participant Flow|Diabetologists|
11005531|NCT01080976|OG000|Outcome|Primary Care Physicians|Doctors from General Practice
11005532|NCT01080976|OG001|Outcome|Diabetologists|Doctors Specialized in Diabetes
11005533|NCT01080976|EG000|Reported Event|Primary Care Physicians|
11005534|NCT01080976|EG001|Reported Event|Diabetologists|
11005535|NCT01081041|BG000|Baseline|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005536|NCT01081041|BG001|Baseline|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005537|NCT01081041|BG002|Baseline|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005538|NCT01081041|BG003|Baseline|Total|Total of all reporting groups
11005539|NCT01081041|FG000|Participant Flow|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005540|NCT01081041|FG001|Participant Flow|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005541|NCT01081041|FG002|Participant Flow|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005542|NCT01081041|OG000|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
11005543|NCT01081041|OG001|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
11007932|NCT01093690|FG000|Participant Flow|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
11007933|NCT01093690|FG001|Participant Flow|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
11007934|NCT01093690|OG000|Outcome|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
11007935|NCT01093690|OG001|Outcome|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
11007936|NCT01093690|EG000|Reported Event|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
11007937|NCT01093690|EG001|Reported Event|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
11007938|NCT01093755|BG000|Baseline|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
11007939|NCT01093755|BG001|Baseline|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
11007940|NCT01093755|BG002|Baseline|Total|Total of all reporting groups
11007941|NCT01093755|FG000|Participant Flow|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
11007942|NCT01093755|FG001|Participant Flow|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
11007943|NCT01093755|OG000|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
11007944|NCT01093755|OG001|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
11007945|NCT01093755|EG000|Reported Event|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
11007946|NCT01093755|EG001|Reported Event|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
11007947|NCT01093794|BG000|Baseline|All Participants|
11007948|NCT01093794|FG000|Participant Flow|1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~Co-administration of 50 mg sitagliptin and 500 mg metformin~sitagliptin/metformin 50 mg/500 mg FDC tablet~sitagliptin/metformin 50 mg/850 mg FDC tablet~Co-administration of 50 mg sitagliptin and 850 mg metformin"
11007949|NCT01093794|FG001|Participant Flow|2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~sitagliptin/metformin 50 mg/500 mg FDC tablet~Co-administration of 50 mg sitagliptin and 850 mg metformin~Co-administration of 50 mg sitagliptin and 500mg metformin~sitagliptin/metformin 50 mg/850 mg FDC tablet"
11007950|NCT01093794|FG002|Participant Flow|3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~Co-administration of 50 mg sitagliptin and 850 mg metformin~sitagliptin/metformin 50 mg/850 mg FDC tablet~sitagliptin/metformin 50 mg/500 mg FDC tablet~Co-administration of 50 mg sitagliptin and 500mg metformin"
11007951|NCT01093794|FG003|Participant Flow|4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~sitagliptin/metformin 50 mg/850 mg FDC tablet~Co-administration of 50 mg sitagliptin and 500 mg metformin~Co-administration of 50 mg sitagliptin and 850 mg metformin~sitagliptin/metformin 50 mg/500 mg FDC tablet"
11007952|NCT01093794|OG000|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
11007953|NCT01093794|OG001|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
11007954|NCT01093794|OG002|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
11007955|NCT01093794|OG003|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
11007956|NCT01093794|EG000|Reported Event|Sit 50 mg + Met 500 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 500 mg metformin.
11007957|NCT01093794|EG001|Reported Event|Sit/Met 50 mg/500 mg FDC|AEs reported in participants after administration of the sitagliptin/metformin 50 mg/500 mg fixed dose combination (FDC) tablet.
11007958|NCT01093794|EG002|Reported Event|Sit 50 mg + Met 850 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 850 mg metformin.
11007959|NCT01093794|EG003|Reported Event|Sit/Met 50 mg/850 mg FDC|AEs reported in participants after administration of sitagliptin 50 mg/metformin 850 mg FDC tablet.
11007960|NCT01093885|BG000|Baseline|Open Label: Medication Ambrisentan|"Open label study of Ambrisentan.~Ambrisentan will begin at 5mg daily for the first month.~Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week. Subjects will continue their present dose and schedule of disease modifying/antifibrotic medication for the duration of the study.~Ambrisentan: Drug is dispensed in tablet form. Ambrisentan with anti-fibrotic to assess benefit on skin~Dosing of ambrisentan will begin at 5mg daily for the first month. Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week."
11117643|NCT01686750|OG000|Outcome|Integrated Care Centers|"Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.~HIV voluntary counseling and testing & staging~Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy~Substance abuse counseling~Sexually transmitted infection screening and treatment~Access to free antiretroviral therapy and adherence support~Peer community outreach"
11117644|NCT01686750|EG000|Reported Event|Integrated Care Centers|"Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.~HIV voluntary counseling and testing & staging~Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy~Substance abuse counseling~Sexually transmitted infection screening and treatment~Access to free antiretroviral therapy and adherence support~Peer community outreach"
11117645|NCT01686750|EG001|Reported Event|Standard Services|In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
11117646|NCT01686828|BG000|Baseline|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117647|NCT01686828|BG001|Baseline|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117648|NCT01686828|BG002|Baseline|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117649|NCT01686828|BG003|Baseline|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
11117650|NCT01686828|BG004|Baseline|Total|Total of all reporting groups
11117651|NCT01686828|FG000|Participant Flow|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117652|NCT01686828|FG001|Participant Flow|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117653|NCT01686828|FG002|Participant Flow|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117654|NCT01686828|FG003|Participant Flow|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
11117655|NCT01686828|OG000|Outcome|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117656|NCT01686828|OG001|Outcome|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117657|NCT01686828|OG002|Outcome|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117658|NCT01686828|OG003|Outcome|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
11005544|NCT01081041|OG001|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI),|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
11005545|NCT01081041|OG000|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005546|NCT01081041|OG001|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
11005547|NCT01081041|OG002|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
11005548|NCT01081041|OG000|Outcome|All Participants (Cetuximab)|"United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~OR~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly."
11005549|NCT01081041|OG001|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
11005550|NCT01081041|EG000|Reported Event|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005551|NCT01081041|EG001|Reported Event|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005552|NCT01081041|EG002|Reported Event|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11005553|NCT01081132|BG000|Baseline|PLACEBO|Orally administered a once-daily dose
11005554|NCT01081132|BG001|Baseline|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
11005555|NCT01081132|BG002|Baseline|Total|Total of all reporting groups
11005556|NCT01081132|FG000|Participant Flow|PLACEBO|Orally administered a once-daily dose
11005557|NCT01081132|FG001|Participant Flow|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
11005558|NCT01081132|OG000|Outcome|PLACEBO|Orally administered a once-daily dose
11005559|NCT01081132|OG001|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
11005560|NCT01081132|EG000|Reported Event|PLACEBO|Orally administered a once-daily dose
11005561|NCT01081132|EG001|Reported Event|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
11005562|NCT01081145|BG000|Baseline|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
11005563|NCT01081145|FG000|Participant Flow|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
11005564|NCT01081145|FG001|Participant Flow|Placebo|Administered as a once-daily oral dose
11005565|NCT01081145|OG000|Outcome|Placebo|Administered as a once-daily oral dose
11005566|NCT01081145|OG001|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
11117659|NCT01686828|OG000|Outcome|Acyline + Placebo Gel + Placebo Pills|Acyline (300 mg/kg, subcutaneous injection at weeks 0, 2) + placebo gel + oral placebo pills daily. This treatment regimen resulted in medical castration.
11117660|NCT01686828|OG001|Outcome|Acyline + Testosterone Gel (1.25g/d) + Placebo Pills|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily placebo pills. This group was intended to have low-normal levels of serum testosterone and estradiol.
11117661|NCT01686828|OG002|Outcome|Acyline + Testosterone Gel (5g/d) + Placebo Pills|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily placebo pills. This group was intended to have normal, physiologic levels of serum testosterone and estradiol.
11117662|NCT01686828|OG003|Outcome|Acyline + Testosterone Gel (5g/d) + Letrozole|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily letrozole (pills). This group was intended to have normal levels of serum testosterone with selective estrogen deficiency.
11117663|NCT01686828|EG000|Reported Event|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117664|NCT01686828|EG001|Reported Event|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117665|NCT01686828|EG002|Reported Event|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
11117666|NCT01686828|EG003|Reported Event|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
11117667|NCT01686932|BG000|Baseline|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
11117668|NCT01686932|BG001|Baseline|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
11117669|NCT01686932|BG002|Baseline|Total|Total of all reporting groups
11117670|NCT01686932|FG000|Participant Flow|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
11117671|NCT01686932|FG001|Participant Flow|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
11117672|NCT01686932|OG000|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
11117673|NCT01686932|OG001|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
11117674|NCT01686932|EG000|Reported Event|Vildagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
11117675|NCT01686932|EG001|Reported Event|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
11117676|NCT01686958|BG000|Baseline|MR-Guided Transurethral US Ablation|"MR-Guided Transurethral US Ablation of Prostate Tissue~MR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue."
11117677|NCT01686958|FG000|Participant Flow|MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue|"Technology developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.~Study is a prospective, multi-center, single arm trial conducted in US, Canada and Europe. All subjects received the same treatment.~Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation."
11117678|NCT01686958|OG000|Outcome|MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue|"The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.~Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation."
11117679|NCT01686958|OG000|Outcome|MR-Guided Transurethral Ultrasound of Prostate Tissue Ablation|"The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.~Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation."
11117680|NCT01686958|EG000|Reported Event|MR-Guided Transurethral US Ablation|"MR-Guided Transurethral US Ablation of Prostate Tissue~MR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue."
11117681|NCT01687036|BG000|Baseline|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
11117682|NCT01687036|FG000|Participant Flow|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (single treatment during visit 3)."
11117683|NCT01687036|OG000|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
11117684|NCT01687036|EG000|Reported Event|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
11117685|NCT01687088|BG000|Baseline|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
11117686|NCT01687088|BG001|Baseline|Controls|No significant headache or disability as defined by migraine disability scale.
11117687|NCT01687088|BG002|Baseline|Total|Total of all reporting groups
11117688|NCT01687088|FG000|Participant Flow|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
11117689|NCT01687088|FG001|Participant Flow|Controls|No significant headache or disability as defined by migraine disability scale.
11117690|NCT01687088|OG000|Outcome|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
11117691|NCT01687088|OG001|Outcome|Controls|No significant headache or disability as defined by migraine disability scale.
11117692|NCT01687088|EG000|Reported Event|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
11117693|NCT01687088|EG001|Reported Event|Controls|No significant headache or disability as defined by migraine disability scale.
11117694|NCT01687101|BG000|Baseline|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
11117695|NCT01687101|FG000|Participant Flow|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
11117696|NCT01687101|OG000|Outcome|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
11117697|NCT01687101|EG000|Reported Event|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
11117698|NCT01687114|BG000|Baseline|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
11117699|NCT01687114|FG000|Participant Flow|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
11117700|NCT01687114|OG000|Outcome|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
11117701|NCT01687114|EG000|Reported Event|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
11117702|NCT01687166|BG000|Baseline|Blazer Open-Irrigated Ablation Catheter|"Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system~Blazer Open-Irrigated Ablation Catheter (Boston Scientific)"
11117703|NCT01687166|BG001|Baseline|Control|"FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.~FDA Approved Open-Irrigated Ablation Catheter"
11117704|NCT01687166|BG002|Baseline|Blazer Open-Irrigated Ablation Catheter Roll-In|Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)
11117705|NCT01687166|BG003|Baseline|Control Roll-In|"Non-Randomized Subjects treated with an FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.~FDA Approved Open-Irrigated Ablation Catheter"
11117706|NCT01687166|BG004|Baseline|Total|Total of all reporting groups
11117707|NCT01687166|FG000|Participant Flow|Blazer Open-Irrigated Ablation Catheter|"Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system~Blazer Open-Irrigated Ablation Catheter (Boston Scientific)"
11117708|NCT01687166|FG001|Participant Flow|Control|"FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.~FDA Approved Open-Irrigated Ablation Catheter"
11117709|NCT01687166|FG002|Participant Flow|Blazer Open-Irrigated Ablation Catheter Roll-In|Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)
11117710|NCT01687166|FG003|Participant Flow|Control Roll-In|"Non-Randomized Subjects treated with an FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.~FDA Approved Open-Irrigated Ablation Catheter"
11117711|NCT01687166|OG000|Outcome|Blazer Open-Irrigated Ablation Catheter|"Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system~Blazer Open-Irrigated Ablation Catheter (Boston Scientific)"
11117712|NCT01687166|OG001|Outcome|Control|"FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.~FDA Approved Open-Irrigated Ablation Catheter"
11117713|NCT01687166|EG000|Reported Event|Blazer Open-Irrigated Ablation Catheter Randomized|"Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system~Blazer Open-Irrigated Ablation Catheter (Boston Scientific)"
11117714|NCT01687166|EG001|Reported Event|FDA Approved Open-Irrigated Ablation Catheter Randomized|"FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.~FDA Approved Open-Irrigated Ablation Catheter"
11117715|NCT01687166|EG002|Reported Event|Blazer Open-Irrigated Ablation Catheter Roll-In|"Roll-In Cases for Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system~Blazer Open-Irrigated Ablation Catheter (Boston Scientific)"
11117716|NCT01687166|EG003|Reported Event|FDA Approved Open-Irrigated Ablation Catheter Roll-In|"Roll-In Cases for FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.~FDA Approved Open-Irrigated Ablation Catheter"
11117717|NCT01687179|BG000|Baseline|Sirolimus and Hydroxychloroquine|"Subjects will take sirolimus at an initial dose of 2mg followed by dose adjustment to keep sirolimus trough levels between 5-15ng/ml consistent with the effective dose in the MILES trial. In addition to sirolimus subjects will receive hydroxychloroquine at 200 mg daily or twice a day for 6 months, depending on time of enrollment into the study, following a standard phase I dose escalation.~sirolimus and hydroxychloroquine: This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken orally daily."
11117718|NCT01687179|FG000|Participant Flow|Sirolimus and Hydroxychloroquine 200 mg|This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and hydroxychloroquine 200 mg taken orally daily.
11117719|NCT01687179|FG001|Participant Flow|Sirolimus and HydroxyChloroquine 400 mg|Once safety is established with the lower dose, (Sirolimus and Hydroxychloroquine 200 mg), subjects will receive Sirolimus 2 mg (adjusted to keep trough levels between 5 to 15 ng/ml) and hydroxychloroquine 200 mg twice a day.
11117720|NCT01687179|OG000|Outcome|Sirolimus and Hydroxychloroquine 200 mg|This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and hydroxychloroquine 200 mg taken orally daily. Safety of the drug combination was assessed by the occurrence of adverse events in these 3 patients.
11117721|NCT01687179|OG001|Outcome|Sirolimus and Hydroxychloroquine 400 mg|Once safety is established with the lower dose, (Sirolimus and Hydroxychloroquine 200 mg), subjects will receive Sirolimus 2 mg (adjusted to keep trough levels between 5 to 15 ng/ml) and hydroxychloroquine 200 mg twice a day. Safety of this dose was assessed by the occurrence of adverse events in these 10 patients.
11117722|NCT01687179|EG000|Reported Event|Sirolimus and Hydroxychloroquine 200 mg|This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and hydroxychloroquine 200 mg taken orally daily.
11117723|NCT01687179|EG001|Reported Event|Sirolimus and Hydroxychloroquine 400 mg|Once safety is established with the lower dose, (Sirolimus and Hydroxychloroquine 200 mg), subjects will receive Sirolimus 2 mg (adjusted to keep trough levels between 5 to 15 ng/ml) and hydroxychloroquine 200 mg twice a day.
11117724|NCT01687218|BG000|Baseline|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117725|NCT01687218|BG001|Baseline|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117726|NCT01687218|BG002|Baseline|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117727|NCT01687218|BG003|Baseline|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117728|NCT01687218|BG004|Baseline|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117729|NCT01687218|BG005|Baseline|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117730|NCT01687218|BG006|Baseline|Total|Total of all reporting groups
11117731|NCT01687218|FG000|Participant Flow|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11126782|NCT01735617|FG000|Participant Flow|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
11117732|NCT01687218|FG001|Participant Flow|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117733|NCT01687218|FG002|Participant Flow|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117734|NCT01687218|FG003|Participant Flow|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117735|NCT01687218|FG004|Participant Flow|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117736|NCT01687218|FG005|Participant Flow|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
11117737|NCT01687218|OG000|Outcome|Product 1|Oral (Daily FTC/TDF)
11117738|NCT01687218|OG001|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
11117739|NCT01687218|OG002|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
11117740|NCT01687218|EG000|Reported Event|Product 1|Oral (Daily FTC/TDF)
11117741|NCT01687218|EG001|Reported Event|Product 2|Rectal (Daily TFV RG 1% gel)
11117742|NCT01687218|EG002|Reported Event|Product 3|Rectal (RAI-associated TFV RG 1% gel)
11117743|NCT01687244|BG000|Baseline|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11vps/ml of rAd-IFN/Syn3 arm.
11117744|NCT01687244|BG001|Baseline|rAd-IFN Dose 3x10^11 Vps/ml|Patients were randomly assigned to the 3x10^11vps/ml of rAd-IFN/Syn3 arm.
11117745|NCT01687244|BG002|Baseline|Total|Total of all reporting groups
11117746|NCT01687244|FG000|Participant Flow|rAd-IFN Dose 1x10^11vps/ml|"Patients were randomized to the 1x10^11vps/ml rAd-IFN/Syn3 arm.~A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations."
11117747|NCT01687244|FG001|Participant Flow|rAd-IFN Dose 3x10^11 Vps/ml|"Patients were randomized to the 3x10^11vps/ml rAd-IFN/Syn3 arm.~A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations."
11117748|NCT01687244|OG000|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Subjects were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
11117749|NCT01687244|OG001|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
11117750|NCT01687244|OG000|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11vps/ml rAd-IFN/Syn3 arm.
11117751|NCT01687244|OG001|Outcome|rAd-IFN Dose 3x10^11 Vps/ml|Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
11117752|NCT01687244|OG000|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
11117753|NCT01687244|OG000|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|"Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.~."
11117754|NCT01687244|OG000|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
11117755|NCT01687244|OG000|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
11117756|NCT01687244|OG001|Outcome|rAd-IFN Dose 3x10^11vps/ml|Subjects were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
11117757|NCT01687244|OG001|Outcome|rAd-IFN Dose 3x10^11vps/mL|Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
11117758|NCT01687244|EG000|Reported Event|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomized to the 1x10^11 vps/ml INSTILADRIN arm.
11117759|NCT01687244|EG001|Reported Event|rAd-IFN Dose 3x10^11vps/ml|Patients were randomized the 3x10^11 vps/ml INSTILADRIN arm.
11117760|NCT01687257|BG000|Baseline|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
11117761|NCT01687257|BG001|Baseline|SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
11117762|NCT01687257|BG002|Baseline|Total|Total of all reporting groups
11117763|NCT01687257|FG000|Participant Flow|SOF+RBV (Group 1)|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
11117764|NCT01687257|FG001|Participant Flow|Observation/SOF+RBV (Group 2; Not Treated)|This reporting group only includes participants who were randomized to the Observation/SOF+RBV group who discontinued study prior to receiving study drug.
11117765|NCT01687257|FG002|Participant Flow|Observation/SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
11117766|NCT01687257|OG000|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
11117767|NCT01687257|OG001|Outcome|Observation Period (Group 2)|24 weeks of observation
11117768|NCT01687257|OG002|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
11117769|NCT01687257|OG001|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
11117770|NCT01687257|OG000|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
11117771|NCT01687257|OG002|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 48 weeks
11117772|NCT01687257|OG003|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 48 weeks in both Groups 1 and 2
11117773|NCT01687257|OG002|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
11117774|NCT01687257|OG003|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
11117775|NCT01687257|EG000|Reported Event|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
11117776|NCT01687257|EG001|Reported Event|Observation Period Only (Group 2)|This reporting group includes participants who were randomized to the Observation/SOF+RBV group and received up to 24 weeks of observation.
11117777|NCT01687257|EG002|Reported Event|SOF+RBV Treatment Only (Group 2)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
11117778|NCT01687270|BG000|Baseline|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
11117779|NCT01687270|FG000|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
11117780|NCT01687270|OG000|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
11117781|NCT01687270|EG000|Reported Event|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
11117782|NCT01687283|BG000|Baseline|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
11117783|NCT01687283|BG001|Baseline|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
11117784|NCT01687283|BG002|Baseline|Total|Total of all reporting groups
11117785|NCT01687283|FG000|Participant Flow|FP 1 mg BID|Participants received Fluticasone propionate (FP) oral inhalation (inhal) solution (sol'n) 1 milligram (mg) twice daily (BID) via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
11117786|NCT01687283|FG001|Participant Flow|BUD 2 mg BID|Participants received Budesonide (BUD) oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
11117787|NCT01687283|OG000|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
11117788|NCT01687283|OG001|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
11117789|NCT01687283|EG000|Reported Event|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
11117790|NCT01687283|EG001|Reported Event|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
11117791|NCT01687296|BG000|Baseline|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
11117792|NCT01687296|BG001|Baseline|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
11117793|NCT01687296|BG002|Baseline|Total|Total of all reporting groups
11126783|NCT01735617|OG000|Outcome|Chronocort|Chronocort Modified Release Capsules 10 mg twice-daily.
11126784|NCT01735617|OG000|Outcome|Chroncort|Chronocort Modified Release Capsules 10mg twice-daily
11005567|NCT01081145|OG000|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
11005568|NCT01081145|EG000|Reported Event|Guanfacine Hydrochloride (Open-Label Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
11005569|NCT01081145|EG001|Reported Event|Placebo (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose
11005570|NCT01081145|EG002|Reported Event|Guanfacine Hydrochloride (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
11005571|NCT01081249|BG000|Baseline|Active Drug|"placebo~intranasal oxytocin: single dose of 40 IU intranasal oxytocin or similar volume of placebo~placebo: single dose of 40 IU intranasal oxytocin or similar volume of placebo"
11005572|NCT01081249|FG000|Participant Flow|Oxytocin Then Placebo|Participants received a single dose of 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a similar dose of intranasal placebo.
11005573|NCT01081249|FG001|Participant Flow|Placebo Then Oxytocin|Participants received a single dose of intranasal placebo prior to the first psychotherapy session; prior to the second psychotherapy session the participants received a single dose of 40 IU intranasal oxytocin.
11005574|NCT01081249|OG000|Outcome|Placebo|A dose of intranasal placebo was administered prior to the psychotherapy session.
11005575|NCT01081249|OG001|Outcome|Active Drug|A dose of 40 IU intranasal oxytocin was administered prior to the psychotherapy session.
11005576|NCT01081249|EG000|Reported Event|Placebo Then Oxytocin|Participants received intranasal placebo spray prior to the first psychotherapy session; prior to the second psychotherapy session they received 40 IU intranasal oxytocin.
11005577|NCT01081249|EG001|Reported Event|Oxytocin Then Placebo|Participants received 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a comparable dose of intranasal placebo spray.
11005578|NCT01081301|BG000|Baseline|Living With Hope Program|"The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
11005579|NCT01081301|FG000|Participant Flow|Living With Hope Program|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
11005580|NCT01081301|OG000|Outcome|Living With Hope Program [Baseline]|
11005581|NCT01081301|OG001|Outcome|Living With Hope Program [Day 7]|
11005582|NCT01081301|OG002|Outcome|Living With Hope Program [Day 14]|
11005583|NCT01081301|OG003|Outcome|Living With Hope Program [3 Months]|
11005584|NCT01081301|OG004|Outcome|Living With Hope Program [6 Months]|
11005585|NCT01081301|OG005|Outcome|Living With Hope Program [12 Months]|
11005586|NCT01081301|OG000|Outcome|Living With Hope Program [Baseline]|Baseline Measure
11005587|NCT01081301|OG001|Outcome|Living With Hope Program [Day 7]|"Day 7 Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
11005588|NCT01081301|OG002|Outcome|Living With Hope Program [Day 14]|"Day 14 Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
11005589|NCT01081301|OG003|Outcome|Living With Hope Program [3 Months]|"3 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
11005590|NCT01081301|OG004|Outcome|Living With Hope Program [6 Months]|"6 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
11005591|NCT01081301|OG005|Outcome|Living With Hope Program [12 Months]|"12 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
11126785|NCT01735617|OG000|Outcome|Chronocort|Chronocort Modified Release Capsules 10mg twice-daily
11117794|NCT01687296|FG000|Participant Flow|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution twice daily (BID) 2x0.5 milligrams (mg)/millilitres (mL) via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
11117795|NCT01687296|FG001|Participant Flow|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kilogram (kg) per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
11117796|NCT01687296|OG000|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
11117797|NCT01687296|OG001|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
11117798|NCT01687296|EG000|Reported Event|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
11117799|NCT01687296|EG001|Reported Event|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
11117800|NCT01687387|BG000|Baseline|IPH2102 at 1 mg/kg|"lirilumab (IPH2102/BMS986015) at 1 mg/kg~IPH2102 at 1 mg/kg: every 4 weeks"
11117801|NCT01687387|BG001|Baseline|IPH2102 at 0.1 mg/kg|"lirilumab (IPH2102/BMS986015) at 0.1 mg/kg~IPH2102 at 0.1 mg/kg: every 3 months~Placebo (normal saline solution): every 4 weeks"
11117802|NCT01687387|BG002|Baseline|Placebo (Normal Saline Solution)|"Normal saline solution~Placebo (normal saline solution): every 4 weeks"
11117803|NCT01687387|BG003|Baseline|Total|Total of all reporting groups
11117804|NCT01687387|FG000|Participant Flow|IPH2102 at 1 mg/kg|"lirilumab (IPH2102/BMS986015) at 1 mg/kg~IPH2102 at 1 mg/kg: every 4 weeks"
11117805|NCT01687387|FG001|Participant Flow|IPH2102 at 0.1 mg/kg|"lirilumab (IPH2102/BMS986015) at 0.1 mg/kg~IPH2102 at 0.1 mg/kg: every 3 months~Placebo (normal saline solution): every 4 weeks"
11117806|NCT01687387|FG002|Participant Flow|Placebo (Normal Saline Solution)|"Normal saline solution~Placebo (normal saline solution): every 4 weeks"
11117807|NCT01687387|OG000|Outcome|IPH2102 at 1 mg/kg|"lirilumab (IPH2102/BMS986015) at 1 mg/kg~IPH2102 at 1 mg/kg: every 4 weeks"
11117808|NCT01687387|OG001|Outcome|IPH2102 at 0.1 mg/kg|"lirilumab (IPH2102/BMS986015) at 0.1 mg/kg~IPH2102 at 0.1 mg/kg: every 3 months~Placebo (normal saline solution): every 4 weeks"
11117809|NCT01687387|OG002|Outcome|Placebo (Normal Saline Solution)|"Normal saline solution~Placebo (normal saline solution): every 4 weeks"
11117810|NCT01687387|EG000|Reported Event|IPH2102 at 1 mg/kg|"lirilumab (IPH2102/BMS986015) at 1 mg/kg~IPH2102 at 1 mg/kg: every 4 weeks"
11117811|NCT01687387|EG001|Reported Event|IPH2102 at 0.1 mg/kg|"lirilumab (IPH2102/BMS986015) at 0.1 mg/kg~IPH2102 at 0.1 mg/kg: every 3 months~Placebo (normal saline solution): every 4 weeks"
11117812|NCT01687387|EG002|Reported Event|Placebo (Normal Saline Solution)|"Normal saline solution~Placebo (normal saline solution): every 4 weeks"
10878685|NCT00453973|EG001|Reported Event|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
11117813|NCT01687400|BG000|Baseline|Decitabine|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11117814|NCT01687400|FG000|Participant Flow|Decitabine|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11117815|NCT01687400|OG000|Outcome|Decitabine (Participants With Response of CR/CRi/mCR/PR)|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11117816|NCT01687400|OG001|Outcome|Decitabine (Participants With Response of SD/PD)|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11117817|NCT01687400|OG000|Outcome|Decitabine|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11005592|NCT01081301|OG000|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
11005593|NCT01081301|EG000|Reported Event|Living With Hope Program [Baseline]|
11005594|NCT01081301|EG001|Reported Event|Living With Hope Program [Day 7]|
11005595|NCT01081301|EG002|Reported Event|Living With Hope Program [Day 14]|
11005596|NCT01081301|EG003|Reported Event|Living With Hope Program [3 Months]|
11005597|NCT01081301|EG004|Reported Event|Living With Hope Program [6 Months]|
11005598|NCT01081301|EG005|Reported Event|Living With Hope Program [12 Months]|
11005599|NCT01081626|BG000|Baseline|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
11005600|NCT01081626|BG001|Baseline|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
11005601|NCT01081626|BG002|Baseline|Total|Total of all reporting groups
11005602|NCT01081626|FG000|Participant Flow|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
11005603|NCT01081626|FG001|Participant Flow|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
11005604|NCT01081626|OG000|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
11005605|NCT01081626|OG001|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
11005606|NCT01081626|EG000|Reported Event|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
11005607|NCT01081626|EG001|Reported Event|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
11005608|NCT01081665|BG000|Baseline|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
11005609|NCT01081665|FG000|Participant Flow|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
11005610|NCT01081665|OG000|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
11005611|NCT01081665|EG000|Reported Event|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
11005612|NCT01081678|BG000|Baseline|Placebo|Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005613|NCT01081678|BG001|Baseline|Romosozumab 70 mg|Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005614|NCT01081678|BG002|Baseline|Romosozumab 140 mg|Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005615|NCT01081678|BG003|Baseline|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005616|NCT01081678|BG004|Baseline|Total|Total of all reporting groups
11005617|NCT01081678|FG000|Participant Flow|Placebo|Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005618|NCT01081678|FG001|Participant Flow|Romosozumab 70 mg|Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005619|NCT01081678|FG002|Participant Flow|Romosozumab 140 mg|Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005620|NCT01081678|FG003|Participant Flow|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005621|NCT01081678|OG000|Outcome|Placebo|Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005622|NCT01081678|OG001|Outcome|Romosozumab 70 mg|Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005623|NCT01081678|OG002|Outcome|Romosozumab 140 mg|Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005624|NCT01081678|OG003|Outcome|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005625|NCT01081678|EG000|Reported Event|Placebo|Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005626|NCT01081678|EG001|Reported Event|Romosozumab 70 mg|Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005627|NCT01081678|EG002|Reported Event|Romosozumab 140 mg|Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005628|NCT01081678|EG003|Reported Event|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
11005629|NCT01081769|BG000|Baseline|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
11005630|NCT01081769|BG001|Baseline|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
11005631|NCT01081769|BG002|Baseline|Total|Total of all reporting groups
11005632|NCT01081769|FG000|Participant Flow|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
11005633|NCT01081769|FG001|Participant Flow|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
11005634|NCT01081769|OG000|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
11005635|NCT01081769|OG001|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
11005636|NCT01081769|EG000|Reported Event|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
11005637|NCT01081769|EG001|Reported Event|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
11005638|NCT01081795|BG000|Baseline|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005639|NCT01081795|BG001|Baseline|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005640|NCT01081795|BG002|Baseline|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005641|NCT01081795|BG003|Baseline|Total|Total of all reporting groups
11005642|NCT01081795|FG000|Participant Flow|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005643|NCT01081795|FG001|Participant Flow|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005644|NCT01081795|FG002|Participant Flow|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005645|NCT01081795|OG000|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005646|NCT01081795|OG001|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005647|NCT01081795|OG002|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005648|NCT01081795|EG000|Reported Event|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11117818|NCT01687400|OG000|Outcome|Decitabine (CR/CRi/mCR)|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11117819|NCT01687400|OG001|Outcome|Decitabine (PR/SD/PD)|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11117820|NCT01687400|EG000|Reported Event|Decitabine (First 50 Enrolled Patients)|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11117821|NCT01687400|EG001|Reported Event|Decitabine (Remainder of Enrolled Patients n=64)|Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
11117822|NCT01687413|BG000|Baseline|Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117823|NCT01687413|BG001|Baseline|Radiotherapy, Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117824|NCT01687413|BG002|Baseline|Total|Total of all reporting groups
11117825|NCT01687413|FG000|Participant Flow|Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117826|NCT01687413|FG001|Participant Flow|Radiotherapy, Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117827|NCT01687413|OG000|Outcome|Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117828|NCT01687413|OG001|Outcome|Radiotherapy, Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117829|NCT01687413|OG000|Outcome|Baseline - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117830|NCT01687413|OG001|Outcome|Baseline - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117831|NCT01687413|OG002|Outcome|1 Month - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117832|NCT01687413|OG003|Outcome|1 Month - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
10878686|NCT00453986|BG000|Baseline|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
10878687|NCT00453986|BG001|Baseline|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
11117833|NCT01687413|OG004|Outcome|6 Months - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117834|NCT01687413|OG005|Outcome|6 Months - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117835|NCT01687413|OG006|Outcome|12 Months - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117836|NCT01687413|OG007|Outcome|12 Months - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117837|NCT01687413|OG008|Outcome|24 Months - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117838|NCT01687413|OG009|Outcome|24 Months - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117839|NCT01687413|OG004|Outcome|12 Months - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117840|NCT01687413|OG005|Outcome|12 Months - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117841|NCT01687413|OG006|Outcome|24 Months - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117842|NCT01687413|OG007|Outcome|24 Months - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117843|NCT01687413|OG002|Outcome|12 Months - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117844|NCT01687413|OG003|Outcome|12 Months - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117845|NCT01687413|OG004|Outcome|24 Months - Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117846|NCT01687413|OG005|Outcome|24 Months - Radiotherapy + Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117847|NCT01687413|EG000|Reported Event|Radiotherapy|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117848|NCT01687413|EG001|Reported Event|Radiotherapy, Cisplatin|"Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)~Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).~Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways"
11117849|NCT01687478|BG000|Baseline|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
11117850|NCT01687478|BG001|Baseline|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
11117851|NCT01687478|BG002|Baseline|Total|Total of all reporting groups
11117852|NCT01687478|FG000|Participant Flow|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
11117853|NCT01687478|FG001|Participant Flow|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
11117854|NCT01687478|OG000|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
11117855|NCT01687478|OG001|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
11117856|NCT01687478|EG000|Reported Event|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
11117857|NCT01687478|EG001|Reported Event|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
11117858|NCT01687595|BG000|Baseline|HerpV + QS-21|Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
11117859|NCT01687595|BG001|Baseline|Placebo|Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
11117860|NCT01687595|BG002|Baseline|Total|Total of all reporting groups
11117861|NCT01687595|FG000|Participant Flow|HerpV + QS-21|Participants received a combination of HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
11117862|NCT01687595|FG001|Participant Flow|Placebo|Participants received placebo (phosphate buffered saline [PBS]) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
11117863|NCT01687595|OG000|Outcome|HerpV + QS-21|Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
11117864|NCT01687595|OG001|Outcome|Placebo|Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
11117865|NCT01687595|EG000|Reported Event|HerpV + QS-21|Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
11117866|NCT01687595|EG001|Reported Event|Placebo|Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
11117867|NCT01687673|BG000|Baseline|Treatment|"Combination temsirolimus plus sorafenib~Temsirolimus: 10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.~Sorafenib:: 200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion."
11117868|NCT01687673|FG000|Participant Flow|Treatment|"Combination temsirolimus plus sorafenib~Temsirolimus: 10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.~Sorafenib:: 200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion."
11117869|NCT01687673|OG000|Outcome|Treatment|"Combination temsirolimus plus sorafenib~Temsirolimus: 10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.~Sorafenib:: 200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion."
11117870|NCT01687673|EG000|Reported Event|Treatment|"Combination temsirolimus plus sorafenib~Temsirolimus: 10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.~Sorafenib:: 200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion."
11126786|NCT01735617|OG000|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
11126787|NCT01735617|EG000|Reported Event|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
11126788|NCT01735630|BG000|Baseline|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
11126789|NCT01735630|BG001|Baseline|Placebo|"Matched placebo BID for 12 weeks~Placebo"
11126790|NCT01735630|BG002|Baseline|Total|Total of all reporting groups
11126791|NCT01735630|FG000|Participant Flow|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
11126792|NCT01735630|FG001|Participant Flow|Placebo|"Matched placebo BID for 12 weeks~Placebo"
11126793|NCT01735630|OG000|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
11126794|NCT01735630|OG001|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
11126795|NCT01735630|EG000|Reported Event|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
11126796|NCT01735630|EG001|Reported Event|Placebo|"Matched placebo BID for 12 weeks~Placebo"
11126797|NCT01735877|BG000|Baseline|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
11126798|NCT01735877|BG001|Baseline|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
11126799|NCT01735877|BG002|Baseline|Total|Total of all reporting groups
11126800|NCT01735877|FG000|Participant Flow|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
11126801|NCT01735877|FG001|Participant Flow|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
11126802|NCT01735877|OG000|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
11126803|NCT01735877|OG001|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
11126804|NCT01735877|EG000|Reported Event|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
11117871|NCT01687712|BG000|Baseline|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117872|NCT01687712|BG001|Baseline|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117873|NCT01687712|BG002|Baseline|Total|Total of all reporting groups
11117874|NCT01687712|FG000|Participant Flow|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117875|NCT01687712|FG001|Participant Flow|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117876|NCT01687712|OG000|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117877|NCT01687712|OG001|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117878|NCT01687712|EG000|Reported Event|AFOLIA - Cycle 1|Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117879|NCT01687712|EG001|Reported Event|Gonal-f® RFF - Cycle 1|Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117880|NCT01687712|EG002|Reported Event|AFOLIA - Cycle 2|Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117881|NCT01687712|EG003|Reported Event|Gonal-f® RFF - Cycle 2|Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117882|NCT01687712|EG004|Reported Event|AFOLIA - Cycle 3|Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117883|NCT01687712|EG005|Reported Event|Gonal-f® RFF - Cycle 3|Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
11117884|NCT01687790|BG000|Baseline|Molecular Breast Imaging|molecular breast imaging (Discovery)
11117885|NCT01687790|FG000|Participant Flow|Molecular Breast Imaging|molecular breast imaging (Discovery)
11117886|NCT01687790|OG000|Outcome|Molecular Breast Imaging|Participants received molecular breast imaging before biopsy
11117887|NCT01687790|OG000|Outcome|Molecular Breast Imaging|molecular breast imaging (Discovery)
11117888|NCT01687790|EG000|Reported Event|Molecular Breast Imaging|molecular breast imaging (Discovery)
11117889|NCT01687972|BG000|Baseline|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
11117890|NCT01687972|BG001|Baseline|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
11117891|NCT01687972|BG002|Baseline|Total|Total of all reporting groups
11117892|NCT01687972|FG000|Participant Flow|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
11117893|NCT01687972|FG001|Participant Flow|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
11117894|NCT01687972|OG000|Outcome|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
11117895|NCT01687972|OG001|Outcome|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
11117896|NCT01687972|EG000|Reported Event|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
11117897|NCT01687972|EG001|Reported Event|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
11117898|NCT01687998|BG000|Baseline|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
11117899|NCT01687998|BG001|Baseline|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
11117900|NCT01687998|BG002|Baseline|Total|Total of all reporting groups
11117901|NCT01687998|FG000|Participant Flow|Evacetrapib|Evacetrapib 130 milligram (mg) tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).
11117902|NCT01687998|FG001|Participant Flow|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.
11117903|NCT01687998|OG000|Outcome|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
11117904|NCT01687998|OG001|Outcome|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
11117905|NCT01687998|EG000|Reported Event|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
11117906|NCT01687998|EG001|Reported Event|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
11117907|NCT01688037|BG000|Baseline|Double-Blind Placebo, Then Open-Label 50mg|"Double-Blind Period: Participants first received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
11117908|NCT01688037|BG001|Baseline|Double-Blind 50mg, Then Open-Label 50mg|"Double-Blind Period: Participants first received valbenazine 50mg capsule once daily for 6 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
11117909|NCT01688037|BG002|Baseline|Double-Blind 100mg/50mg, Then Open-Label 50mg|"Double-Blind Period: Participants first received valbenazine 100mg capsule once daily for 2 weeks, then they received valbenazine 50mg capsule once daily for 4 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
11117910|NCT01688037|BG003|Baseline|Total|Total of all reporting groups
11117911|NCT01688037|FG000|Participant Flow|Double-Blind Placebo, Then Open-Label 50mg|"Double-Blind Period: Participants first received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
11117912|NCT01688037|FG001|Participant Flow|Double-Blind 50mg, Then Open-Label 50mg|"Double-Blind Period: Participants first received valbenazine 50mg capsule once daily for 6 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
11117913|NCT01688037|FG002|Participant Flow|Double-Blind 100mg/50mg, Then Open-Label 50mg|"Double-Blind Period: Participants first received valbenazine 100mg capsule once daily for 2 weeks, then they received valbenazine 50mg capsule once daily for 4 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
11117914|NCT01688037|OG000|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.
11117915|NCT01688037|OG001|Outcome|All Valbenazine|Includes participants who received valbenazine 50mg capsule once daily for 6 weeks and participants who received valbenazine 100mg capsule once daily for 2 weeks, then 50mg capsule once daily for 4 weeks (a total of 6 weeks).
11117916|NCT01688037|OG001|Outcome|Valbenazine 50mg and Valbenazine 100mg Then 50mg|Includes participants who received valbenazine 50mg capsule once daily for 6 weeks and participants who received valbenazine 100mg capsule once daily for 2 weeks, then 50mg capsule once daily for 4 weeks (a total of 6 weeks).
11117917|NCT01688037|OG001|Outcome|Valbenazine 50mg|Participants received valbenazine 50mg capsule once daily for 2 weeks.
11117918|NCT01688037|OG002|Outcome|Valbenazine 100mg|Participants received valbenazine 100mg capsule once daily for 2 weeks.
11117919|NCT01688037|EG000|Reported Event|Double-Blind 50mg|Double-Blind Period: Participants received valbenazine 50mg capsule once daily for 6 weeks.
11117920|NCT01688037|EG001|Reported Event|Double-Blind 100mg/50mg|Double-Blind Period: Participants received valbenazine 100mg capsule once daily for 2 weeks, then they received valbenazine 50mg capsule once daily for 4 weeks.
11117921|NCT01688037|EG002|Reported Event|Double-Blind Placebo|Double-Blind Period: Participants received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.
11117922|NCT01688037|EG003|Reported Event|Open-Label 50mg|Open-Label Period: Participants who completed the double-blind period entered the open-label period to receive valbenazine 50mg capsule for an additional 6 weeks of treatment.
11117923|NCT01688037|EG004|Reported Event|Follow-Up|Participants who completed the open-label period entered the 4-week follow-up period.
11117924|NCT01688050|BG000|Baseline|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft
11117925|NCT01688050|FG000|Participant Flow|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft
11117926|NCT01688050|OG000|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft
11117927|NCT01688050|EG000|Reported Event|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft
11117928|NCT01688102|BG000|Baseline|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
11117929|NCT01688102|BG001|Baseline|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
11117930|NCT01688102|BG002|Baseline|Total|Total of all reporting groups
11117931|NCT01688102|FG000|Participant Flow|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
11117932|NCT01688102|FG001|Participant Flow|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
11005649|NCT01081795|EG001|Reported Event|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005650|NCT01081795|EG002|Reported Event|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
11005651|NCT01081834|BG000|Baseline|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
11005652|NCT01081834|BG001|Baseline|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
11005653|NCT01081834|BG002|Baseline|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
11005654|NCT01081834|BG003|Baseline|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
11005655|NCT01081834|BG004|Baseline|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks.
11005656|NCT01081834|BG005|Baseline|Total|Total of all reporting groups
11005657|NCT01081834|FG000|Participant Flow|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
11005658|NCT01081834|FG001|Participant Flow|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
11005659|NCT01081834|FG002|Participant Flow|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
11005660|NCT01081834|FG003|Participant Flow|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
11005661|NCT01081834|FG004|Participant Flow|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
11005662|NCT01081834|OG000|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
11005663|NCT01081834|OG001|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
11005664|NCT01081834|OG002|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
11005665|NCT01081834|OG000|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
11005666|NCT01081834|OG001|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
11005667|NCT01081834|OG002|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
11005668|NCT01081834|OG000|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
11005669|NCT01081834|OG000|Outcome|Placebo|In the Main study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
11005670|NCT01081834|OG002|Outcome|Canagliflozin 300 mg|In the High Glycemic substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
11005671|NCT01081834|EG000|Reported Event|Main Study (Baseline to Week 26): Placebo|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26.
11005672|NCT01081834|EG001|Reported Event|Main Study (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
11005673|NCT01081834|EG002|Reported Event|Main Study (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
11005674|NCT01081834|EG003|Reported Event|Main Study (Baseline to Week 52): Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52.
11005675|NCT01081834|EG004|Reported Event|Main Study (Baseline to Week 52): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
11005676|NCT01081834|EG005|Reported Event|Main Study (Baseline to Week 52): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
11005677|NCT01081834|EG006|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
11005678|NCT01081834|EG007|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
11117933|NCT01688102|OG000|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
11117934|NCT01688102|OG001|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
11117935|NCT01688102|EG000|Reported Event|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
11117936|NCT01688102|EG001|Reported Event|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
11117937|NCT01688141|BG000|Baseline|Control|Usual care
11117938|NCT01688141|BG001|Baseline|Enhanced Management|"Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed.~Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care."
11117939|NCT01688141|BG002|Baseline|Total|Total of all reporting groups
11117940|NCT01688141|FG000|Participant Flow|Control|Usual care
11117941|NCT01688141|FG001|Participant Flow|Enhanced Management|"Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed.~Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care."
11117942|NCT01688141|OG000|Outcome|Control|Usual care
11117943|NCT01688141|OG001|Outcome|Enhanced Management|"Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed.~Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care."
11117944|NCT01688141|EG000|Reported Event|Control|Usual care
11117945|NCT01688141|EG001|Reported Event|Enhanced Management|"Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed.~Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care."
11117946|NCT01688310|BG000|Baseline|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
11117947|NCT01688310|BG001|Baseline|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
11117948|NCT01688310|BG002|Baseline|Total|Total of all reporting groups
11117949|NCT01688310|FG000|Participant Flow|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
11117950|NCT01688310|FG001|Participant Flow|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
11117951|NCT01688310|OG000|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
11117952|NCT01688310|OG001|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
11117953|NCT01688310|OG000|Outcome|Senior Physicians|Physicians who had extensive prior experience performing open surgical circumcisions.
11117954|NCT01688310|OG001|Outcome|Junior Physicians|Physicians who had very limited prior experience performing open surgical circumcisions.
11117955|NCT01688310|EG000|Reported Event|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
11117956|NCT01688310|EG001|Reported Event|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
11117957|NCT01688336|BG000|Baseline|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
11117958|NCT01688336|FG000|Participant Flow|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
11117959|NCT01688336|OG000|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
11117960|NCT01688336|OG000|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
11117961|NCT01688336|EG000|Reported Event|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
11117962|NCT01688466|BG000|Baseline|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
11117963|NCT01688466|BG001|Baseline|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
11117964|NCT01688466|BG002|Baseline|Total|Total of all reporting groups
11117965|NCT01688466|FG000|Participant Flow|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
11117966|NCT01688466|FG001|Participant Flow|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
11117967|NCT01688466|OG000|Outcome|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
11117968|NCT01688466|OG001|Outcome|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
11117969|NCT01688466|EG000|Reported Event|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
11117970|NCT01688466|EG001|Reported Event|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
11117971|NCT01688596|BG000|Baseline|No Treatment|"The No Treatment group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine."
11117972|NCT01688596|BG001|Baseline|Bupivacaine|"The Bupivacaine Arm includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.~Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case."
11117973|NCT01688596|BG002|Baseline|Total|Total of all reporting groups
11117974|NCT01688596|FG000|Participant Flow|No Treatment|"The No Treatment group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine."
11117975|NCT01688596|FG001|Participant Flow|Bupivacaine|"The Bupivacaine Arm includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.~Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case."
11117976|NCT01688596|OG000|Outcome|No Treatment|"The No Treatment group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine."
11117977|NCT01688596|OG001|Outcome|Bupivacaine|"The Bupivacaine Arm includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.~Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case."
11117978|NCT01688596|EG000|Reported Event|No Treatment|"The No Treatment group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine."
11117979|NCT01688596|EG001|Reported Event|Bupivacaine|"The Bupivacaine Arm includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.~Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case."
11117980|NCT01688609|BG000|Baseline|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11117981|NCT01688609|FG000|Participant Flow|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11117982|NCT01688609|OG000|Outcome|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11117983|NCT01688609|EG000|Reported Event|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11117984|NCT01688635|BG000|Baseline|LY2963016 and US-approved Lantus|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study; Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
11117985|NCT01688635|FG000|Participant Flow|LY/Lantus/LY/Lantus|"A single 0.5-units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.~A single 0.5-U/kg dose of US-approved Lantus (Lantus) administered subcutaneously during Periods 2 and 4.~There was at least a 7-day washout between treatment periods."
11117986|NCT01688635|FG001|Participant Flow|Lantus/LY/Lantus/LY|"A single 0.5-U/kg dose of US-approved Lantus administered subcutaneously during Periods 1 and 3.~A single 0.5-U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.~There was at least a 7-day washout between treatment periods."
11117987|NCT01688635|OG000|Outcome|LY2963016|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
11117988|NCT01688635|OG001|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
11117989|NCT01688635|OG000|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
11117990|NCT01688635|EG000|Reported Event|LY2963016|"Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between the treatment periods."
11117991|NCT01688635|EG001|Reported Event|US-approved Lantus|"Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between the treatment periods."
11117992|NCT01688726|BG000|Baseline|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
11117993|NCT01688726|BG001|Baseline|Minims Saline|One drop 4 times a day for a continuous period of 1 month
11117994|NCT01688726|BG002|Baseline|Total|Total of all reporting groups
11117995|NCT01688726|FG000|Participant Flow|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
11117996|NCT01688726|FG001|Participant Flow|Minims Saline|One drop 4 times a day for a continuous period of 1 month
11117997|NCT01688726|OG000|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
11117998|NCT01688726|OG001|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
11117999|NCT01688726|OG000|Outcome|SYSTANE BALANCE/Right Eye|One drop 4 times a day for 1 month
11118000|NCT01688726|OG001|Outcome|SYSTANE BALANCE/Left Eye|One drop 4 times a day for 1 month
11118001|NCT01688726|OG002|Outcome|Minims Saline/Right Eye|One drop 4 times a day for 1 month
11118002|NCT01688726|OG003|Outcome|Minims Saline/Left Eye|One drop 4 times a day for 1 month
11118003|NCT01688726|EG000|Reported Event|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
11118004|NCT01688726|EG001|Reported Event|Minims Saline|One drop 4 times a day for a continuous period of 1 month
11118005|NCT01688739|BG000|Baseline|Healthy: Placebo|Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
11118006|NCT01688739|BG001|Baseline|Healthy: Erenumab 1 mg SC|Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
11118007|NCT01688739|BG002|Baseline|Healthy: Erenumab 7 mg SC|Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
11118008|NCT01688739|BG003|Baseline|Healthy: Erenumab 21 mg SC|Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
11118009|NCT01688739|BG004|Baseline|Healthy: Erenumab 70 mg SC|Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
11118010|NCT01688739|BG005|Baseline|Healthy: Erenumab 140 mg SC|Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118011|NCT01688739|BG006|Baseline|Healthy: Erenumab 140 mg IV|Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
11118012|NCT01688739|BG007|Baseline|Healthy: Erenumab 210 mg SC|Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
11118013|NCT01688739|BG008|Baseline|Migraine: Placebo|Participants with migraine received a single dose of placebo administered by subcutaneous injection.
11118014|NCT01688739|BG009|Baseline|Migraine: Erenumab 140 mg SC|Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118015|NCT01688739|BG010|Baseline|Total|Total of all reporting groups
11118016|NCT01688739|FG000|Participant Flow|Healthy: Placebo|Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
11118017|NCT01688739|FG001|Participant Flow|Healthy: Erenumab 1 mg SC|Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
11118018|NCT01688739|FG002|Participant Flow|Healthy: Erenumab 7 mg SC|Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
11118019|NCT01688739|FG003|Participant Flow|Healthy: Erenumab 21 mg SC|Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
11118020|NCT01688739|FG004|Participant Flow|Healthy: Erenumab 70 mg SC|Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
11118021|NCT01688739|FG005|Participant Flow|Healthy: Erenumab 140 mg SC|Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118022|NCT01688739|FG006|Participant Flow|Healthy: Erenumab 140 mg IV|Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
11118023|NCT01688739|FG007|Participant Flow|Healthy: Erenumab 210 mg SC|Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
11118024|NCT01688739|FG008|Participant Flow|Migraine: Placebo|Participants with migraine received a single dose of placebo administered by subcutaneous injection.
11118025|NCT01688739|FG009|Participant Flow|Migraine: Erenumab 140 mg SC|Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118026|NCT01688739|OG000|Outcome|Healthy: Placebo|Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
11118027|NCT01688739|OG001|Outcome|Healthy: Erenumab 1 mg SC|Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
11118028|NCT01688739|OG002|Outcome|Healthy: Erenumab 7 mg SC|Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
11118029|NCT01688739|OG003|Outcome|Healthy: Erenumab 21 mg SC|Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
11118030|NCT01688739|OG004|Outcome|Healthy: Erenumab 70 mg SC|Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
11118031|NCT01688739|OG005|Outcome|Healthy: Erenumab 140 mg SC|Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118032|NCT01688739|OG006|Outcome|Healthy: Erenumab 140 mg IV|Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
11118033|NCT01688739|OG007|Outcome|Healthy: Erenumab 210 mg SC|Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
11118034|NCT01688739|OG008|Outcome|Migraine: Placebo|Participants with migraine received a single dose of placebo administered by subcutaneous injection.
11118035|NCT01688739|OG009|Outcome|Migraine: Erenumab 140 mg SC|Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118036|NCT01688739|OG000|Outcome|Healthy: Erenumab 1 mg SC|Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
11118037|NCT01688739|OG001|Outcome|Healthy: Erenumab 7 mg SC|Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
11118038|NCT01688739|OG002|Outcome|Healthy: Erenumab 21 mg SC|Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
11118039|NCT01688739|OG003|Outcome|Healthy: Erenumab 70 mg SC|Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
11118040|NCT01688739|OG004|Outcome|Healthy: Erenumab 140 mg SC|Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118041|NCT01688739|OG005|Outcome|Healthy: Erenumab 140 mg IV|Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
11118042|NCT01688739|OG006|Outcome|Healthy: Erenumab 210 mg SC|Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
11118043|NCT01688739|OG007|Outcome|Migraine: Erenumab 140 mg SC|Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118044|NCT01688739|EG000|Reported Event|Healthy: Placebo|Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
11118045|NCT01688739|EG001|Reported Event|Healthy: Erenumab 1 mg SC|Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
11118046|NCT01688739|EG002|Reported Event|Healthy: Erenumab 7 mg SC|Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
11118047|NCT01688739|EG003|Reported Event|Healthy: Erenumab 21 mg SC|Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
11118048|NCT01688739|EG004|Reported Event|Healthy: Erenumab 70 mg SC|Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
11118049|NCT01688739|EG005|Reported Event|Healthy: Erenumab 140 mg SC|Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118050|NCT01688739|EG006|Reported Event|Healthy: Erenumab 140 mg IV|Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
11118051|NCT01688739|EG007|Reported Event|Healthy: Erenumab 210 mg SC|Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
11118052|NCT01688739|EG008|Reported Event|Migraine: Placebo|Participants with migraine received a single dose of placebo administered by subcutaneous injection.
11118053|NCT01688739|EG009|Reported Event|Migraine: Erenumab 140 mg SC|Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
11118054|NCT01688830|BG000|Baseline|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
11118055|NCT01688830|BG001|Baseline|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118056|NCT01688830|BG002|Baseline|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118057|NCT01688830|BG003|Baseline|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118058|NCT01688830|BG004|Baseline|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118059|NCT01688830|BG005|Baseline|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118060|NCT01688830|BG006|Baseline|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118061|NCT01688830|BG007|Baseline|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
11118062|NCT01688830|BG008|Baseline|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
11118063|NCT01688830|BG009|Baseline|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
11118064|NCT01688830|BG010|Baseline|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
11118065|NCT01688830|BG011|Baseline|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
11118066|NCT01688830|BG012|Baseline|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
11118067|NCT01688830|BG013|Baseline|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118068|NCT01688830|BG014|Baseline|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
11118069|NCT01688830|BG015|Baseline|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118070|NCT01688830|BG016|Baseline|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118071|NCT01688830|BG017|Baseline|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118072|NCT01688830|BG018|Baseline|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118073|NCT01688830|BG019|Baseline|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118074|NCT01688830|BG020|Baseline|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118075|NCT01688830|BG021|Baseline|Total|Total of all reporting groups
11118076|NCT01688830|FG000|Participant Flow|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
11118077|NCT01688830|FG001|Participant Flow|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118078|NCT01688830|FG002|Participant Flow|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118079|NCT01688830|FG003|Participant Flow|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118080|NCT01688830|FG004|Participant Flow|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118081|NCT01688830|FG005|Participant Flow|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118082|NCT01688830|FG006|Participant Flow|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118083|NCT01688830|FG007|Participant Flow|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
11118084|NCT01688830|FG008|Participant Flow|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
11118085|NCT01688830|FG009|Participant Flow|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
11118086|NCT01688830|FG010|Participant Flow|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
11118087|NCT01688830|FG011|Participant Flow|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
11118088|NCT01688830|FG012|Participant Flow|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
11118089|NCT01688830|FG013|Participant Flow|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118090|NCT01688830|FG014|Participant Flow|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
11118091|NCT01688830|FG015|Participant Flow|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118092|NCT01688830|FG016|Participant Flow|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118093|NCT01688830|FG017|Participant Flow|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118094|NCT01688830|FG018|Participant Flow|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118095|NCT01688830|FG019|Participant Flow|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118096|NCT01688830|FG020|Participant Flow|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118097|NCT01688830|OG000|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118098|NCT01688830|OG001|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118099|NCT01688830|OG002|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118100|NCT01688830|OG003|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118101|NCT01688830|OG004|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118102|NCT01688830|OG005|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118103|NCT01688830|OG006|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
11118104|NCT01688830|OG007|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
11118105|NCT01688830|OG008|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
11118106|NCT01688830|OG009|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
11118107|NCT01688830|OG010|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
11118108|NCT01688830|OG011|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118109|NCT01688830|OG012|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
11118110|NCT01688830|OG013|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118111|NCT01688830|OG014|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118112|NCT01688830|OG015|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118113|NCT01688830|OG016|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118114|NCT01688830|OG000|Outcome|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
11118115|NCT01688830|OG001|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118116|NCT01688830|OG002|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118117|NCT01688830|OG003|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118118|NCT01688830|OG004|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
11118119|NCT01688830|OG005|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118120|NCT01688830|OG006|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118121|NCT01688830|OG007|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
11118122|NCT01688830|OG008|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
11118123|NCT01688830|OG009|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
11118124|NCT01688830|OG010|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
11118125|NCT01688830|OG011|Outcome|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
11118126|NCT01688830|OG012|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
11118127|NCT01688830|OG013|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
11118128|NCT01688830|OG014|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
11118129|NCT01688830|OG015|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118130|NCT01688830|OG016|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118131|NCT01688830|OG017|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118132|NCT01688830|OG018|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118133|NCT01688830|OG019|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118134|NCT01688830|OG020|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118135|NCT01688830|OG000|Outcome|DE (Dose Groups 14-16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
11118136|NCT01688830|OG001|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118137|NCT01688830|OG002|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118138|NCT01688830|OG003|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118139|NCT01688830|OG004|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118140|NCT01688830|OG005|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
11118141|NCT01688830|OG006|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118142|NCT01688830|OG007|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118143|NCT01688830|OG000|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118144|NCT01688830|OG001|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118145|NCT01688830|OG002|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118146|NCT01688830|OG003|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118147|NCT01688830|OG004|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118148|NCT01688830|OG005|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118149|NCT01688830|OG001|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118150|NCT01688830|OG002|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118151|NCT01688830|OG003|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118152|NCT01688830|OG000|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118153|NCT01688830|OG001|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118154|NCT01688830|EG000|Reported Event|Placebo 1 h|One single intravenous long infusion (1 h) of Idarucizumab Placebo
11118155|NCT01688830|EG001|Reported Event|20 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
11118156|NCT01688830|EG002|Reported Event|60 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
11118157|NCT01688830|EG003|Reported Event|200 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
11118158|NCT01688830|EG004|Reported Event|600 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
11118159|NCT01688830|EG005|Reported Event|1.2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
11118160|NCT01688830|EG006|Reported Event|2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
11118161|NCT01688830|EG007|Reported Event|3 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
11118162|NCT01688830|EG008|Reported Event|4 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
11118163|NCT01688830|EG009|Reported Event|6 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
11118164|NCT01688830|EG010|Reported Event|8 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
11118165|NCT01688830|EG011|Reported Event|Placebo 5min|One single intravenous short infusion (5 min) of Idarucizumab Placebo
11118166|NCT01688830|EG012|Reported Event|1 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
11118167|NCT01688830|EG013|Reported Event|2 g Idarucizumab 5min|Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
11118168|NCT01688830|EG014|Reported Event|4 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
11118169|NCT01688830|EG015|Reported Event|DE (Dose Groups 14-16)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose groups 14-16
11118170|NCT01688830|EG016|Reported Event|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118171|NCT01688830|EG017|Reported Event|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1g of Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118172|NCT01688830|EG018|Reported Event|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118173|NCT01688830|EG019|Reported Event|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118174|NCT01688830|EG020|Reported Event|DE (Dose Groups 17)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose group 17
11118175|NCT01688830|EG021|Reported Event|DE+ Placebo|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118176|NCT01688830|EG022|Reported Event|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118177|NCT01688830|EG023|Reported Event|DE+ 5 g|"One single intravenous short infusion (5 min) of 5 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118178|NCT01688830|EG024|Reported Event|DE+ 5 g + 2.5 g Idarucizumab|"Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
11118179|NCT01688843|BG000|Baseline|INGEVITY Lead|INGEVITY lead implant
11118180|NCT01688843|FG000|Participant Flow|INGEVITY Study Participants|Each participant was allowed to have up to 2 INGEVITY leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.
11118181|NCT01688843|OG000|Outcome|INGEVITY Lead|Implanted/Attempted Leads
11118182|NCT01688843|OG000|Outcome|INGEVITY Lead|INGEVITY lead implant
11118183|NCT01688843|OG000|Outcome|INGEVITY Lead|"INGEVITY lead implant~INGEVITY lead"
11118184|NCT01688843|EG000|Reported Event|INGEVITY Study Participants|
11118185|NCT01688856|BG000|Baseline|Arm+Hand CCFES|"Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session."
11118186|NCT01688856|BG001|Baseline|Hand CCFES|"Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session."
11118187|NCT01688856|BG002|Baseline|Arm+Hand Cyclic NMES|"Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session."
11118188|NCT01688856|BG003|Baseline|Total|Total of all reporting groups
11118189|NCT01688856|FG000|Participant Flow|Arm+Hand CCFES|"Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session."
11005679|NCT01081873|BG000|Baseline|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. Age was available for 2,691 patients only; age was missing for 23 patients who were thus not included in the age results.
11005680|NCT01081873|FG000|Participant Flow|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
11005681|NCT01081873|OG000|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
11005682|NCT01081873|OG001|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
11005683|NCT01081873|OG002|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
11005684|NCT01081873|OG003|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
11005685|NCT01081873|OG004|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
11005686|NCT01081873|OG005|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
11005687|NCT01081873|OG006|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
11005688|NCT01081873|OG007|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
11005689|NCT01081873|OG008|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
11005690|NCT01081873|OG009|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
11005691|NCT01081873|OG000|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
11005692|NCT01081873|OG001|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
11005693|NCT01081873|OG002|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
11005694|NCT01081873|OG003|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
11005695|NCT01081873|OG004|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
11005696|NCT01081873|OG005|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
11005697|NCT01081873|OG006|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
11005698|NCT01081873|OG007|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
11005699|NCT01081873|OG008|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
11005700|NCT01081873|OG009|Outcome|Advanced Prostate Cancer Participants - Use at Any Visit|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had used any of the treatments at any visit.
11005701|NCT01081873|OG000|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
10878688|NCT00453986|BG002|Baseline|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
11005702|NCT01081873|OG000|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a tissue type recorded at Baseline.
11005703|NCT01081873|OG000|Outcome|Advanced Prostate Cancer Participants - Rectal Examination|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via rectal examination.
11005704|NCT01081873|OG001|Outcome|Advanced Prostate Cancer Participants - Prostate Biopsy|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via a prostate biopsy.
11005705|NCT01081873|OG002|Outcome|Advanced Prostate Cancer Participants - Echograph|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via an echograph (hyperechogenic zones).
11005706|NCT01081873|OG003|Outcome|Advanced Prostate Cancer Participants - MRI|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via MRI.
11005707|NCT01081873|EG000|Reported Event|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
11005708|NCT01081912|BG000|Baseline|Open-label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label)
11005709|NCT01081912|FG000|Participant Flow|Conversion/Titration Phase - Open-Label|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
11005710|NCT01081912|FG001|Participant Flow|Double-Blind Treatment Phase|"Treatment Phase: Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
11005711|NCT01081912|FG002|Participant Flow|Double-Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.~Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
11005712|NCT01081912|OG000|Outcome|Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
11005713|NCT01081912|OG001|Outcome|Placebo Comparator|Placebo: Capsules, no active substance, shells identical to active comparator capsules
11005714|NCT01081912|EG000|Reported Event|Open-Label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
11005715|NCT01081912|EG001|Reported Event|Double Blind Treatment Phase: Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
11005716|NCT01081912|EG002|Reported Event|Double Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.~Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
11005717|NCT01082081|BG000|Baseline|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
11005718|NCT01082081|BG001|Baseline|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
11005719|NCT01082081|BG002|Baseline|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
11005720|NCT01082081|BG003|Baseline|Total|Total of all reporting groups
11005721|NCT01082081|FG000|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (total dose= 1000 mg), with 150 milliliter (mL) of water through oral route.
11005722|NCT01082081|FG001|Participant Flow|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
11005723|NCT01082081|FG002|Participant Flow|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
11005724|NCT01082081|OG000|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
11005725|NCT01082081|OG001|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
11005726|NCT01082081|OG002|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
11005727|NCT01082081|EG000|Reported Event|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
11005728|NCT01082081|EG001|Reported Event|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
11005729|NCT01082081|EG002|Reported Event|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
11005730|NCT01082159|BG000|Baseline|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
11005731|NCT01082159|FG000|Participant Flow|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
11005732|NCT01082159|OG000|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
11005733|NCT01082159|OG000|Outcome|Lumbar Decompression|Single arm cohort having percutaneous lumbar decompression using the mild Device Kit.
11005734|NCT01082159|EG000|Reported Event|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
11005735|NCT01082328|BG000|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
11005736|NCT01082328|FG000|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
11005737|NCT01082328|OG000|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
11005738|NCT01082328|EG000|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
11005739|NCT01082367|BG000|Baseline|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
11005740|NCT01082367|BG001|Baseline|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
11005741|NCT01082367|BG002|Baseline|Total|Total of all reporting groups
11005742|NCT01082367|FG000|Participant Flow|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
11005743|NCT01082367|FG001|Participant Flow|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
11005744|NCT01082367|OG000|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
11005745|NCT01082367|OG001|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
11005746|NCT01082367|EG000|Reported Event|DB TOBI|DB TOBI
11005747|NCT01082367|EG001|Reported Event|DB Placebo|DB Placebo
11005748|NCT01082367|EG002|Reported Event|OL TOBI (Core)|OL TOBI (core)
11005749|NCT01082367|EG003|Reported Event|Off-treatment (Core)|Off-treatment (core)
11005750|NCT01082367|EG004|Reported Event|OL TOBI (Follow-up)|OL TOBI (follow-up)
11005751|NCT01082367|EG005|Reported Event|Off-treatment (Follow-up)|Off-treatment (follow-up)
11005752|NCT01082380|BG000|Baseline|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
11005753|NCT01082380|FG000|Participant Flow|PF-02341066 250 mg|Single oral dose of PF-02341066 250 milligram (mg) containing 100 micro-curie (μCi) Carbon -14[14C].
11005754|NCT01082380|OG000|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
11118190|NCT01688856|FG001|Participant Flow|Hand CCFES|"Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session."
11118191|NCT01688856|FG002|Participant Flow|Arm+Hand Cyclic NMES|"Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session."
11118192|NCT01688856|OG000|Outcome|Arm+Hand CCFES|"Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session."
11118193|NCT01688856|OG001|Outcome|Hand CCFES|"Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session."
11118194|NCT01688856|OG002|Outcome|Arm+Hand Cyclic NMES|"Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session."
11118195|NCT01688856|EG000|Reported Event|Arm+Hand CCFES|"Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session."
11118196|NCT01688856|EG001|Reported Event|Hand CCFES|"Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session."
11118197|NCT01688856|EG002|Reported Event|Arm+Hand Cyclic NMES|"Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.~Electrical stimulator: The 12-week treatment period consists of two components:~Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)~Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session."
11118198|NCT01688882|BG000|Baseline|QGE031|QGE031 240 mg Q2W s.c.
11118199|NCT01688882|BG001|Baseline|Placebo|Placebo to Match Q2W s.c.
11118200|NCT01688882|BG002|Baseline|Total|Total of all reporting groups
11118201|NCT01688882|FG000|Participant Flow|QGE031|QGE031 240 mg Q2W s.c.
11118202|NCT01688882|FG001|Participant Flow|Placebo|Placebo to Match Q2W s.c.
11118203|NCT01688882|OG000|Outcome|QGE031|QGE031 240 mg Q2W s.c.
11118204|NCT01688882|OG001|Outcome|Placebo|Placebo to Match Q2W s.c.
11118205|NCT01688882|EG000|Reported Event|QGE031|QGE031 240 mg Q2W s.c
11118206|NCT01688882|EG001|Reported Event|Placebo|Placebo to Match Q2W s.c.
11118207|NCT01688882|EG002|Reported Event|Open Label QGE031|Open Label QGE031 Q2W s.c.
11118208|NCT01688882|EG003|Reported Event|Follow-up Period: QGE031|Follow-up Period after completion of Part 1 QGE031 240 mg Q2W s.c.
11118209|NCT01688882|EG004|Reported Event|Follow-up Period: Placebo|Follow-up Period after completion of Part 1 Placebo to Match Q2W s.c.
11118210|NCT01688882|EG005|Reported Event|Follow-up Period: Open Label QGE031|Follow-up Period after completion of Part 1 Open Label QGE031 Q2W s.c.
11118211|NCT01688895|BG000|Baseline|Adult Patients With EPP/XLP|Individuals with a documented diagnosis of Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
11118212|NCT01688895|FG000|Participant Flow|Adult Patients With EPP/XLP|Individuals with a documented diagnosis of Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
11118213|NCT01688895|OG000|Outcome|Adult Patients With EPP/XLP|Individuals with a documented diagnosis of Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
11118214|NCT01688895|EG000|Reported Event|Adult Patients With EPP/XLP|Individuals with a documented diagnosis of Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
11118215|NCT01688921|BG000|Baseline|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
11118216|NCT01688921|BG001|Baseline|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
11118217|NCT01688921|BG002|Baseline|Total|Total of all reporting groups
11118218|NCT01688921|FG000|Participant Flow|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
11118219|NCT01688921|FG001|Participant Flow|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
11118220|NCT01688921|OG000|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
11118221|NCT01688921|OG001|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
11118222|NCT01688921|OG000|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
11118223|NCT01688921|EG000|Reported Event|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
11118224|NCT01688921|EG001|Reported Event|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
11118225|NCT01688973|BG000|Baseline|Arm I (Tivantinib)|"Patients receive tivantinib PO BID on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11118226|NCT01688973|BG001|Baseline|Arm II (Tivantinib and Erlotinib Hydrochloride)|"Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11118227|NCT01688973|BG002|Baseline|Total|Total of all reporting groups
11118228|NCT01688973|FG000|Participant Flow|Arm I (Tivantinib)|"Patients receive tivantinib PO BID on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11118229|NCT01688973|FG001|Participant Flow|Arm II (Tivantinib and Erlotinib Hydrochloride)|"Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11118230|NCT01688973|OG000|Outcome|Arm I (Tivantinib)|"Patients receive tivantinib PO BID on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11118231|NCT01688973|OG001|Outcome|Arm II (Tivantinib and Erlotinib Hydrochloride)|"Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11118232|NCT01688973|OG000|Outcome|Pooled Arms|Pooled treatment arms for translational medicine objectives. Arms were pooled due to no difference in response rate between the two arms.
11118233|NCT01688973|EG000|Reported Event|Arm I (Tivantinib)|"Patients receive tivantinib PO BID on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11118234|NCT01688973|EG001|Reported Event|Arm II (Tivantinib and Erlotinib Hydrochloride)|"Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11118235|NCT01688999|BG000|Baseline|Cohort 1 - (Urothelial Progressive Disease)|Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118236|NCT01688999|BG001|Baseline|Cohort 2 (Bone-only)|Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118237|NCT01688999|BG002|Baseline|Cohort 3 (Rare Histologies)|Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118238|NCT01688999|BG003|Baseline|Total|Total of all reporting groups
11118239|NCT01688999|FG000|Participant Flow|Cohort 1 - (Urothelial Progressive Disease)|Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118240|NCT01688999|FG001|Participant Flow|Cohort 2 (Bone-only)|Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118241|NCT01688999|FG002|Participant Flow|Cohort 3 (Rare Histologies)|Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118242|NCT01688999|OG000|Outcome|Cohort 1 - (Urothelial Progressive Disease)|Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118243|NCT01688999|OG001|Outcome|Cohort 2 (Bone-only)|Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118244|NCT01688999|OG002|Outcome|Cohort 3 (Rare Histologies)|Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
11118245|NCT01688999|OG000|Outcome|All Participants|"Cohort 1 - (urothelial progressive disease) Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.~Cohort 2 (Bone-only) Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.~Cohort 3 (Rare histologies) Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis."
11118246|NCT01688999|EG000|Reported Event|All Participants|"Cohort 1 - (urothelial progressive disease) Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.~Cohort 2 (Bone-only) Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.~Cohort 3 (Rare histologies) Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis."
11005755|NCT01082380|EG000|Reported Event|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
11005756|NCT01082575|BG000|Baseline|Major Surgery|Post Operative patients
11005757|NCT01082575|FG000|Participant Flow|Major Surgery|Post Operative patients
11005758|NCT01082575|OG000|Outcome|General Care Floor|Observational General Care Floor Group
11005759|NCT01082575|EG000|Reported Event|Major Surgery|Post Operative patients
11005760|NCT01082588|BG000|Baseline|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
11005761|NCT01082588|BG001|Baseline|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
11005762|NCT01082588|BG002|Baseline|Total|Total of all reporting groups
11005763|NCT01082588|FG000|Participant Flow|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
11005764|NCT01082588|FG001|Participant Flow|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
11005765|NCT01082588|OG000|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
11005766|NCT01082588|OG001|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
11005767|NCT01082588|EG000|Reported Event|Pravastatin|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks~Pravastatin: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
11005768|NCT01082588|EG001|Reported Event|Placebo|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks~Placebo: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
11005769|NCT01082614|BG000|Baseline|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
11005770|NCT01082614|BG001|Baseline|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
11005771|NCT01082614|BG002|Baseline|Total|Total of all reporting groups
11005772|NCT01082614|FG000|Participant Flow|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
11005773|NCT01082614|FG001|Participant Flow|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
11005774|NCT01082614|OG000|Outcome|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
11005775|NCT01082614|OG001|Outcome|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
11005776|NCT01082614|EG000|Reported Event|Standard Fluid Management|
11005777|NCT01082614|EG001|Reported Event|Goal Directed Therapy|
11005778|NCT01082640|BG000|Baseline|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
11005779|NCT01082640|BG001|Baseline|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
11005780|NCT01082640|BG002|Baseline|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
11005781|NCT01082640|BG003|Baseline|Total|Total of all reporting groups
11005782|NCT01082640|FG000|Participant Flow|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
11005783|NCT01082640|FG001|Participant Flow|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
11005784|NCT01082640|FG002|Participant Flow|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
11005785|NCT01082640|OG000|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
11005786|NCT01082640|OG001|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
11005787|NCT01082640|OG002|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
11005788|NCT01082640|OG000|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
11005789|NCT01082640|OG001|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
11005790|NCT01082640|OG002|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
11005791|NCT01082640|EG000|Reported Event|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
11005792|NCT01082640|EG001|Reported Event|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
11005793|NCT01082640|EG002|Reported Event|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
11118247|NCT01689155|BG000|Baseline|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
11118248|NCT01689155|FG000|Participant Flow|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
11118249|NCT01689155|OG000|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
11118250|NCT01689155|OG001|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
11118251|NCT01689155|EG000|Reported Event|Menactra Vaccine Recipients|Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
11118252|NCT01689207|BG000|Baseline|Part A: Placebo|Placebo
11118253|NCT01689207|BG001|Baseline|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
11118254|NCT01689207|BG002|Baseline|Part B: Placebo|Placebo
11118255|NCT01689207|BG003|Baseline|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
11118256|NCT01689207|BG004|Baseline|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
11118257|NCT01689207|BG005|Baseline|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
11118258|NCT01689207|BG006|Baseline|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
11118259|NCT01689207|BG007|Baseline|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
11118260|NCT01689207|BG008|Baseline|Part C: Placebo|Placebo
11118261|NCT01689207|BG009|Baseline|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
11118262|NCT01689207|BG010|Baseline|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
11118263|NCT01689207|BG011|Baseline|Total|Total of all reporting groups
11118264|NCT01689207|FG000|Participant Flow|Part A: Placebo|Placebo
11118265|NCT01689207|FG001|Participant Flow|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
11118266|NCT01689207|FG002|Participant Flow|Part B: Placebo|Placebo
11118267|NCT01689207|FG003|Participant Flow|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
11118268|NCT01689207|FG004|Participant Flow|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
11118269|NCT01689207|FG005|Participant Flow|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
11118270|NCT01689207|FG006|Participant Flow|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
11118271|NCT01689207|FG007|Participant Flow|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
11118272|NCT01689207|FG008|Participant Flow|Part C: Placebo|Placebo
11118273|NCT01689207|FG009|Participant Flow|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
11118274|NCT01689207|FG010|Participant Flow|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
11118275|NCT01689207|OG000|Outcome|Part A: Placebo|Placebo
11118276|NCT01689207|OG001|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
11118277|NCT01689207|OG002|Outcome|Part B: Placebo|Placebo
11118278|NCT01689207|OG003|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
11118279|NCT01689207|OG004|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
11118280|NCT01689207|OG005|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
11118281|NCT01689207|OG006|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
11118282|NCT01689207|OG007|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
11118283|NCT01689207|OG008|Outcome|Part C: Placebo|Placebo
11118284|NCT01689207|OG009|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
11118285|NCT01689207|OG010|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
11118286|NCT01689207|OG011|Outcome|Part A: Aztreonam (ATM) 2000mg|Crossover period ATm 2000mg
11118287|NCT01689207|OG012|Outcome|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
11118288|NCT01689207|OG013|Outcome|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
11118289|NCT01689207|EG000|Reported Event|Part A: Placebo|Placebo
11118290|NCT01689207|EG001|Reported Event|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
11118291|NCT01689207|EG002|Reported Event|Part B: Placebo|Placebo
11118292|NCT01689207|EG003|Reported Event|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
11118293|NCT01689207|EG004|Reported Event|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
11118294|NCT01689207|EG005|Reported Event|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
11118295|NCT01689207|EG006|Reported Event|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
11118296|NCT01689207|EG007|Reported Event|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
11118297|NCT01689207|EG008|Reported Event|Part C: Placebo|Placebo
11118298|NCT01689207|EG009|Reported Event|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
11118299|NCT01689207|EG010|Reported Event|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
11118300|NCT01689207|EG011|Reported Event|Part A: Aztreonam (ATM) 2000mg|Crossover period ATM 2000mg
11118301|NCT01689207|EG012|Reported Event|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
11118302|NCT01689207|EG013|Reported Event|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
11118303|NCT01689324|BG000|Baseline|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
11118304|NCT01689324|FG000|Participant Flow|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
11118305|NCT01689324|OG000|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
11118306|NCT01689324|EG000|Reported Event|Study Group|Participants received a single booster dose of Tdap vaccine on Day 0.
11118307|NCT01689337|BG000|Baseline|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
11118308|NCT01689337|FG000|Participant Flow|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
11118309|NCT01689337|OG000|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
11118310|NCT01689337|OG000|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
11118311|NCT01689337|OG000|Outcome|AS902330, 100 mcg|AS902330 was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
11118312|NCT01689337|EG000|Reported Event|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
11118313|NCT01689350|BG000|Baseline|Control Group|45 cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.
11118314|NCT01689350|BG001|Baseline|Experimental Group|47 cases in experimental group were genotyped as extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM）with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.
11118315|NCT01689350|BG002|Baseline|Total|Total of all reporting groups
11118316|NCT01689350|FG000|Participant Flow|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
11118317|NCT01689350|FG001|Participant Flow|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
11118318|NCT01689350|OG000|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
11118319|NCT01689350|OG001|Outcome|Control Group|CPA medication was according to the traditional experiences.
11118320|NCT01689350|EG000|Reported Event|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
11118321|NCT01689350|EG001|Reported Event|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
11118322|NCT01689363|BG000|Baseline|Total Study Population|Subjects received four intradermal injections of study drug (two injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL), one injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL), one injection of 0.02 mL saline) in a random order at four locations on the subjects' forearms.
11118323|NCT01689363|FG000|Participant Flow|H, N, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
11118324|NCT01689363|FG001|Participant Flow|H, N, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
11118325|NCT01689363|FG002|Participant Flow|H, P, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
11118326|NCT01689363|FG003|Participant Flow|H, P, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
11118327|NCT01689363|FG004|Participant Flow|N, H, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
11118328|NCT01689363|FG005|Participant Flow|N, H, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
11126805|NCT01735877|EG001|Reported Event|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
11118329|NCT01689363|FG006|Participant Flow|P, H, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
11118330|NCT01689363|FG007|Participant Flow|P, H, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
11118331|NCT01689363|OG000|Outcome|Per-Protocol Population (PPP)|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments
11118332|NCT01689363|OG000|Outcome|Intent-to-Treat Population (ITT)|Subjects who have been randomized
11118333|NCT01689363|OG000|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
11118334|NCT01689363|OG001|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
11118335|NCT01689363|OG002|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
11118336|NCT01689363|EG000|Reported Event|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
11118337|NCT01689363|EG001|Reported Event|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
11118338|NCT01689363|EG002|Reported Event|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
11118339|NCT01689363|EG003|Reported Event|All Arms|Cannot identify which study drug may be associated with the ADE because the subject received all four injections almost at the same time
11118340|NCT01689441|BG000|Baseline|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
11118341|NCT01689441|BG001|Baseline|Placebo|"Normal saline 2cc IV x 1~Placebo"
11118342|NCT01689441|BG002|Baseline|Total|Total of all reporting groups
11118343|NCT01689441|FG000|Participant Flow|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
11118344|NCT01689441|FG001|Participant Flow|Placebo|"Normal saline 2cc IV x 1~Placebo"
11118345|NCT01689441|OG000|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
11118346|NCT01689441|OG001|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
11118347|NCT01689441|EG000|Reported Event|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
11118348|NCT01689441|EG001|Reported Event|Placebo|"Normal saline 2cc IV x 1~Placebo"
11118349|NCT01689532|BG000|Baseline|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
11118350|NCT01689532|BG001|Baseline|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
11118351|NCT01689532|BG002|Baseline|Total|Total of all reporting groups
11118352|NCT01689532|FG000|Participant Flow|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
11118353|NCT01689532|FG001|Participant Flow|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
11118354|NCT01689532|OG000|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
11118355|NCT01689532|OG001|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
11118356|NCT01689532|EG000|Reported Event|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
11118357|NCT01689532|EG001|Reported Event|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
11118358|NCT01689649|BG000|Baseline|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
11118359|NCT01689649|FG000|Participant Flow|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
11118360|NCT01689649|OG000|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
11118361|NCT01689649|EG000|Reported Event|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral (PO) in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
11118362|NCT01689701|BG000|Baseline|Hizikia Fusiformis Extract|"Hizikia Fusiformis extract(1.3g/d) for 12weeks~Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated"
11118363|NCT01689701|BG001|Baseline|Placebo|"Placebo(1.3g/day) for 4weeks~Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract."
11118364|NCT01689701|BG002|Baseline|Total|Total of all reporting groups
11118365|NCT01689701|FG000|Participant Flow|Hizikia Fusiformis Extract|"Hizikia Fusiformis extract(1.3g/d) for 12weeks~Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated"
11118366|NCT01689701|FG001|Participant Flow|Placebo|"Placebo(1.3g/day) for 4weeks~Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract."
11118367|NCT01689701|OG000|Outcome|Hizikia Fusiformis Extract|"Hizikia Fusiformis extract(1.3g/d) for 12weeks~Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated"
11118368|NCT01689701|OG001|Outcome|Placebo|"Placebo(1.3g/day) for 4weeks~Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract."
11118369|NCT01689701|EG000|Reported Event|Hizikia Fusiformis Extract|"Hizikia Fusiformis extract(1.3g/d) for 12weeks~Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated"
11118370|NCT01689701|EG001|Reported Event|Placebo|"Placebo(1.3g/day) for 4weeks~Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract."
11118371|NCT01689779|BG000|Baseline|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
11118372|NCT01689779|BG001|Baseline|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
11118373|NCT01689779|BG002|Baseline|Total|Total of all reporting groups
11118374|NCT01689779|FG000|Participant Flow|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
11118375|NCT01689779|FG001|Participant Flow|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
11118376|NCT01689779|OG000|Outcome|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
11118377|NCT01689779|OG001|Outcome|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
11118378|NCT01689779|EG000|Reported Event|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
11118379|NCT01689779|EG001|Reported Event|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
11118380|NCT01689857|BG000|Baseline|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
11118381|NCT01689857|BG001|Baseline|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
11118382|NCT01689857|BG002|Baseline|Total|Total of all reporting groups
11118383|NCT01689857|FG000|Participant Flow|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
11118384|NCT01689857|FG001|Participant Flow|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
11118385|NCT01689857|OG000|Outcome|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
11118386|NCT01689857|OG001|Outcome|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
11118387|NCT01689857|EG000|Reported Event|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
11118388|NCT01689857|EG001|Reported Event|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
11118389|NCT01690000|BG000|Baseline|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
11118390|NCT01690000|BG001|Baseline|Placebo|Identical placebo given nightly for 12 months
11118391|NCT01690000|BG002|Baseline|Total|Total of all reporting groups
11118392|NCT01690000|FG000|Participant Flow|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
11118393|NCT01690000|FG001|Participant Flow|Placebo|Identical placebo given nightly for 12 months
11118394|NCT01690000|OG000|Outcome|Melatonin1+3|"1+3 mg melatonin nightly~Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
11118395|NCT01690000|OG001|Outcome|Placebo|"Identical placebo given nightly~Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
11118396|NCT01690000|EG000|Reported Event|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
11118397|NCT01690000|EG001|Reported Event|Placebo|Identical placebo given nightly for 12 months
11118398|NCT01690052|BG000|Baseline|All Participants|"Two interventions were assembled:~For the first intervention, the SEQUENCE was cevimeline (30mg three times a day) for 4 weeks and then Pilocarpine (5 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week.~For the second intervention, the SEQUENCE was Pilocarpine (5mg three times a day) or 4 weeks and then Cevimeline (30 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week."
11118399|NCT01690052|FG000|Participant Flow|Cevimeline First, Then Pilocarpine|Cevimeline First then Pilocarpine: Cevimeline (30mg three times a day) for 4 weeks (First intervention period) and then pilocarpine (5 mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
11118400|NCT01690052|FG001|Participant Flow|Pilocarpine First, Then Cevimeline|Pilocarpine First then Cevimeline: Pilocarpine (5 mg three times a day) for 4 weeks (first intervention period) and then Cevimeline (30mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
11118401|NCT01690052|OG000|Outcome|Cevimeline|Cevimeline 30mg administered three times a day in first intervention period or second intervention period for 4 weeks.
11118402|NCT01690052|OG001|Outcome|Pilocarpine|Pilocarpine 5 mg administered three times a day in either first intervention period or second intervention period
11118403|NCT01690052|EG000|Reported Event|Cevimeline Then Pilocarpine (Intervention 1)|Cevimeline then pilocarpine One week washout period
11118404|NCT01690052|EG001|Reported Event|Pilocarpine Then Cevimeline (Intervention 2)|Pilocarpine then cevimeline One week washout period
11118405|NCT01690117|BG000|Baseline|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer's Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
11118406|NCT01690117|BG001|Baseline|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
11118407|NCT01690117|BG002|Baseline|Total|Total of all reporting groups
11118408|NCT01690117|FG000|Participant Flow|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer's Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
11118409|NCT01690117|FG001|Participant Flow|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
11118410|NCT01690117|OG000|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer's Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
11118411|NCT01690117|OG001|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
11118412|NCT01690117|OG000|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer's Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
11118413|NCT01690117|OG001|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
11118414|NCT01690117|EG000|Reported Event|Intervention Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
11118415|NCT01690117|EG001|Reported Event|Control Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
11118416|NCT01690130|BG000|Baseline|Transcranial Magnetic Stimulation, Then Sham|"Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.~Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain."
11118417|NCT01690130|BG001|Baseline|Sham Transcranial Magnetic Stimulation, Then TMS|"Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)~Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.~Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS."
11118418|NCT01690130|BG002|Baseline|Total|Total of all reporting groups
11118419|NCT01690130|FG000|Participant Flow|Transcranial Magnetic Stimulation, Then Sham|"Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.~Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain."
11118420|NCT01690130|FG001|Participant Flow|Sham Transcranial Magnetic Stimulation, Then TMS|"Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)~Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.~Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS."
11118421|NCT01690130|OG000|Outcome|Transcranial Magnetic Stimulation|"Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.~Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain."
11126806|NCT01735916|BG000|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
11126807|NCT01735916|BG001|Baseline|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
11126808|NCT01735916|BG002|Baseline|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
11118422|NCT01690130|OG001|Outcome|Sham Transcranial Magnetic Stimulation|"Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)~Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.~Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS."
11118423|NCT01690130|EG000|Reported Event|Transcranial Magnetic Stimulation|"Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.~Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain."
11118424|NCT01690130|EG001|Reported Event|Sham Transcranial Magnetic Stimulation|"Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)~Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.~Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS."
11118425|NCT01690143|BG000|Baseline|Carfilzomib + High Dose Melphalan|"Single arm.~Carfilzomib: Subjects will receive the appropriate dose of carfilzomib (according to assigned cohort in phase 1 and at the determined MTD in phase 2) on days -3 and -2. Carfilzomib will be infused over 30 minutes. Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs.~Melphalan: Subjects will receive 200 mg/m2 of intravenous melphalan on Day -2. Administered as an intravenous push or a fast infusion according to institutional standard operating procedure (SOP). Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs."
11118426|NCT01690143|FG000|Participant Flow|Carfilzomib + High Dose Melphalan|"Single arm.~Carfilzomib: Subjects will receive the appropriate dose of carfilzomib (according to assigned cohort in phase 1 and at the determined MTD in phase 2) on days -3 and -2. Carfilzomib will be infused over 30 minutes. Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs.~Melphalan: Subjects will receive 200 mg/m2 of intravenous melphalan on Day -2. Administered as an intravenous push or a fast infusion according to institutional standard operating procedure (SOP). Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs."
11118427|NCT01690143|OG000|Outcome|Patients Undergoing Transplantation|All patients who receive transplant in the phase 1 of the study
11118428|NCT01690143|OG000|Outcome|Patients Undergoing Transplantation|All patients who receive transplant in the phase 1+2 of the study
11118429|NCT01690143|EG000|Reported Event|Patients Undergoing Transplantation|All patients who receive transplant in the phase 1+2 of the study
11118430|NCT01690273|BG000|Baseline|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
11118431|NCT01690273|BG001|Baseline|Stretching in AS|"stretching exercises~stretching exercise: 30 minutes, twice a week for sixteen weeks."
11118432|NCT01690273|BG002|Baseline|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises~stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
11118433|NCT01690273|BG003|Baseline|Total|Total of all reporting groups
11118434|NCT01690273|FG000|Participant Flow|Ankylosing Spondylitis Control|control group, no intervention in ankylosing spondylitis patients
11118435|NCT01690273|FG001|Participant Flow|Mobility in Ankylosing Spondylitis|"mobility exercises~mobility exercise: 30 minutes, twice a week"
11118436|NCT01690273|FG002|Participant Flow|Mobility and Elastic Resistance Exercise in AS|"mobility, plus elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
11118437|NCT01690273|OG000|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
11118438|NCT01690273|OG001|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
11118439|NCT01690273|OG002|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
11118440|NCT01690273|OG000|Outcome|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
11118441|NCT01690273|OG001|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week for sixteen weeks."
11118442|NCT01690273|OG002|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
11118443|NCT01690273|OG000|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
11118444|NCT01690273|EG000|Reported Event|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
11126809|NCT01735916|BG003|Baseline|Total|Total of all reporting groups
11118445|NCT01690273|EG001|Reported Event|Stretching in AS|"stretching exercises~stretching exercise: 30 minutes, twice a week for sixteen weeks."
11118446|NCT01690273|EG002|Reported Event|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises~stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
11118447|NCT01690520|BG000|Baseline|Arm I (Standard of Care)|"CONDITIONING REGIMEN: One of two possible conditioning regimens is chosen by the attending physician: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6., and undergo high dose TBI BID on days -4 to -1 OR Patients receive fludarabine phosphate IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo middle intensity TBI QD on days -2 to -1.~TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0.~GVHD PROPHYLAXIS: Patients receive cyclosporine IV over 1 hour BID (adults) or TID (children) or PO on days -3 to 100 with taper beginning on day 101. Patients also receive MMF IV TID a day on days 0-7 then may receive MMF PO TID. Patients remain on MMF TID for a minimum of 30 days, and then may begin a taper if there is no evidence of GVHD and are well-engrafted from one donor unit.~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given IV or PO~Thiotepa: Given IV~Total-Body Irradiation: Undergo high dose or middle intensity TBI~Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant"
11118448|NCT01690520|BG001|Baseline|Arm II (Experimental)|"CONDITIONING REGIMEN: Patients receive the conditioning regimen chosen by the attending physician as in Standard of Care Arm.~TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0. Patients also undergo infusion of ex vivo-expanded cord blood progenitor cell infusion at least 4 hours after completion of UCB transplant.~GVHD PROPHYLAXIS: Patients receive cyclosporine IV or PO and mycophenolate mofetil IV or PO as in Standard of Care Arm.~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion: Given IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given IV or PO~Thiotepa: Given IV~Total-Body Irradiation: Undergo high dose or middle intensity TBI~Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant"
11118449|NCT01690520|BG002|Baseline|Total|Total of all reporting groups
11118450|NCT01690520|FG000|Participant Flow|Arm I (Standard of Care)|"CONDITIONING REGIMEN: One of two possible conditioning regimens is chosen by the attending physician: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6., and undergo high dose TBI BID on days -4 to -1 OR Patients receive fludarabine phosphate IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo middle intensity TBI QD on days -2 to -1.~TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0.~GVHD PROPHYLAXIS: Patients receive cyclosporine IV over 1 hour BID (adults) or TID (children) or PO on days -3 to 100 with taper beginning on day 101. Patients also receive MMF IV TID a day on days 0-7 then may receive MMF PO TID. Patients remain on MMF TID for a minimum of 30 days, and then may begin a taper if there is no evidence of GVHD and are well-engrafted from one donor unit.~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given IV or PO~Thiotepa: Given IV~Total-Body Irradiation: Undergo high dose or middle intensity TBI~Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant"
11118451|NCT01690520|FG001|Participant Flow|Arm II (Experimental)|"CONDITIONING REGIMEN: Patients receive the conditioning regimen chosen by the attending physician as in Standard of Care Arm.~TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0. Patients also undergo infusion of ex vivo-expanded cord blood progenitor cell infusion at least 4 hours after completion of UCB transplant.~GVHD PROPHYLAXIS: Patients receive cyclosporine IV or PO and mycophenolate mofetil IV or PO as in Standard of Care Arm.~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion: Given IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given IV or PO~Thiotepa: Given IV~Total-Body Irradiation: Undergo high dose or middle intensity TBI~Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant"
11118452|NCT01690520|OG000|Outcome|Arm I (Standard of Care)|"CONDITIONING REGIMEN: One of two possible conditioning regimens is chosen by the attending physician: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6., and undergo high dose TBI BID on days -4 to -1 OR Patients receive fludarabine phosphate IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo middle intensity TBI QD on days -2 to -1.~TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0.~GVHD PROPHYLAXIS: Patients receive cyclosporine IV over 1 hour BID (adults) or TID (children) or PO on days -3 to 100 with taper beginning on day 101. Patients also receive MMF IV TID a day on days 0-7 then may receive MMF PO TID. Patients remain on MMF TID for a minimum of 30 days, and then may begin a taper if there is no evidence of GVHD and are well-engrafted from one donor unit.~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given IV or PO~Thiotepa: Given IV~Total-Body Irradiation: Undergo high dose or middle intensity TBI~Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant"
11118453|NCT01690520|OG001|Outcome|Arm II (Experimental)|"CONDITIONING REGIMEN: Patients receive the conditioning regimen chosen by the attending physician as in Standard of Care Arm.~TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0. Patients also undergo infusion of ex vivo-expanded cord blood progenitor cell infusion at least 4 hours after completion of UCB transplant.~GVHD PROPHYLAXIS: Patients receive cyclosporine IV or PO and mycophenolate mofetil IV or PO as in Standard of Care Arm.~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion: Given IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given IV or PO~Thiotepa: Given IV~Total-Body Irradiation: Undergo high dose or middle intensity TBI~Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant"
11126810|NCT01735916|FG000|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
11118454|NCT01690520|EG000|Reported Event|Arm I (Standard of Care)|"CONDITIONING REGIMEN: One of two possible conditioning regimens is chosen by the attending physician: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6., and undergo high dose TBI BID on days -4 to -1 OR Patients receive fludarabine phosphate IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo middle intensity TBI QD on days -2 to -1.~TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0.~GVHD PROPHYLAXIS: Patients receive cyclosporine IV over 1 hour BID (adults) or TID (children) or PO on days -3 to 100 with taper beginning on day 101. Patients also receive MMF IV TID a day on days 0-7 then may receive MMF PO TID. Patients remain on MMF TID for a minimum of 30 days, and then may begin a taper if there is no evidence of GVHD and are well-engrafted from one donor unit.~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given IV or PO~Thiotepa: Given IV~Total-Body Irradiation: Undergo high dose or middle intensity TBI~Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant"
11118455|NCT01690520|EG001|Reported Event|Arm II (Experimental)|"CONDITIONING REGIMEN: Patients receive the conditioning regimen chosen by the attending physician as in Standard of Care Arm.~TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0. Patients also undergo infusion of ex vivo-expanded cord blood progenitor cell infusion at least 4 hours after completion of UCB transplant.~GVHD PROPHYLAXIS: Patients receive cyclosporine IV or PO and mycophenolate mofetil IV or PO as in Standard of Care Arm.~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion: Given IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given IV or PO~Thiotepa: Given IV~Total-Body Irradiation: Undergo high dose or middle intensity TBI~Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant"
11118456|NCT01690546|BG000|Baseline|BUP/VLNXT to VIVITROL|
11118457|NCT01690546|FG000|Participant Flow|BUP/VLNXT to VIVITROL|
11118458|NCT01690546|OG000|Outcome|BUP/VLNXT to VIVITROL|
11118459|NCT01690546|EG000|Reported Event|BUP/VLNXT to VIVITROL|
11118460|NCT01690663|BG000|Baseline|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
11118461|NCT01690663|BG001|Baseline|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
11118462|NCT01690663|BG002|Baseline|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
11118463|NCT01690663|BG003|Baseline|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
11118464|NCT01690663|BG004|Baseline|Total|Total of all reporting groups
11118465|NCT01690663|FG000|Participant Flow|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
11118466|NCT01690663|FG001|Participant Flow|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
11118467|NCT01690663|FG002|Participant Flow|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
11118468|NCT01690663|FG003|Participant Flow|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
11118469|NCT01690663|OG000|Outcome|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
11118470|NCT01690663|OG001|Outcome|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
11118471|NCT01690663|OG002|Outcome|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
11118472|NCT01690663|OG003|Outcome|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
11118473|NCT01690663|EG000|Reported Event|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
11118474|NCT01690663|EG001|Reported Event|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
11118475|NCT01690663|EG002|Reported Event|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
11118476|NCT01690663|EG003|Reported Event|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
11118477|NCT01690923|BG000|Baseline|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
11118478|NCT01690923|FG000|Participant Flow|Nasal Mask First, Then Pillows Mask|"Sequence 1: Nasal mask first, then Pillows mask~[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
11118479|NCT01690923|FG001|Participant Flow|Pillows Mask First, Then Nasal Mask|"Sequence 2: Pillows mask first, then Nasal mask~[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
11118480|NCT01690923|OG000|Outcome|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
11118481|NCT01690923|EG000|Reported Event|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
11118482|NCT01690988|BG000|Baseline|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118483|NCT01690988|BG001|Baseline|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
11118484|NCT01690988|BG002|Baseline|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118485|NCT01690988|BG003|Baseline|Total|Total of all reporting groups
11118486|NCT01690988|FG000|Participant Flow|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118487|NCT01690988|FG001|Participant Flow|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
11118488|NCT01690988|FG002|Participant Flow|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118489|NCT01690988|OG000|Outcome|Ketamine (0.5 mg/kg and 1 mg/kg)|"Both the 0.5 mg/kg and the 1mg/kg doses groups of Ketamine were combined for analysis)~Low dose Ketamine (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118490|NCT01690988|OG001|Outcome|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
11118491|NCT01690988|OG000|Outcome|Ketamine (0.5 mg/kg )|"Low dose ketamine (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118492|NCT01690988|OG002|Outcome|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction anesthesia or administration of sedative medications."
11118493|NCT01690988|OG000|Outcome|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118494|NCT01690988|OG002|Outcome|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118495|NCT01690988|EG000|Reported Event|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118496|NCT01690988|EG001|Reported Event|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
11118497|NCT01690988|EG002|Reported Event|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
11118498|NCT01691014|BG000|Baseline|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
11118499|NCT01691014|BG001|Baseline|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118500|NCT01691014|BG002|Baseline|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
10878689|NCT00453986|BG003|Baseline|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
11118501|NCT01691014|BG003|Baseline|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118502|NCT01691014|BG004|Baseline|Total|Total of all reporting groups
11118503|NCT01691014|FG000|Participant Flow|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
11118504|NCT01691014|FG001|Participant Flow|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118505|NCT01691014|FG002|Participant Flow|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118506|NCT01691014|FG003|Participant Flow|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118507|NCT01691014|OG000|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
11118508|NCT01691014|OG001|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118509|NCT01691014|OG002|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118510|NCT01691014|OG003|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118511|NCT01691014|EG000|Reported Event|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
11118512|NCT01691014|EG001|Reported Event|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118513|NCT01691014|EG002|Reported Event|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118514|NCT01691014|EG003|Reported Event|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
11118515|NCT01691027|BG000|Baseline|Crossover Design. All Subjects Undergo All Treatments.|Each participating subject will have three training modules on a tablet computer: scotoma awareness, line and curve tracing, and video games. The order of modules will be different for different groups of subjects. Training on a module will cease when the subject reaches a performance criterion. Retinal assessments will occur after each training module completion.
11118516|NCT01691027|FG000|Participant Flow|Visuo-motor Training for Low Vision|All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games
11118517|NCT01691027|OG000|Outcome|Visuo-motor Training|Participants undergo training on three modules, (1)scotoma awareness, (2) line and curve tracing, and (3) video games. SLO assessments of changes in fine manual task performance was measured by an improvement in mean maze tracing and printing score. Improvement in visuo-motor control was measured by stylus ellipse area and stylus-PRL distance before and after training.
11118518|NCT01691027|OG000|Outcome|SLO Measurements Pre and Post-training|"All subjects trained on two computer-based training modules. SLO assessment of changes in fine manual task performance and in retinal functional geography was done before training and after each training module~SLO measurements pre and post-training"
11118519|NCT01691027|EG000|Reported Event|Subjects With Bilateral AMD, no Foveal Vision and 20/60 Vision|"Crossover design. All subjects undergo all treatments.~Practice tracing objects and printing with a stylus on a tablet computer: Subjects will have three training modules on a tablet computer: scotoma awareness, line and curve tracing, and video games. The order of modules will be different for different groups of subjects. Training on a module will cease when the subject reaches a performance criterion. Retinal assessments will occur after each training module completion."
11118520|NCT01691092|BG000|Baseline|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
11118521|NCT01691092|FG000|Participant Flow|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
11118522|NCT01691092|OG000|Outcome|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
11118523|NCT01691092|EG000|Reported Event|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
11118524|NCT01691105|BG000|Baseline|Academic Detailing (AD)|Standard of care for patients who are smokers and admitted to the hospital.
11118525|NCT01691105|BG001|Baseline|AD + Integrated Tobacco Order Set|"Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center~AD + Integrated Tobacco Order Set: Physician will have access to:~NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center"
11118526|NCT01691105|BG002|Baseline|Total|Total of all reporting groups
11118527|NCT01691105|FG000|Participant Flow|Academic Detailing (AD)|Standard of care for patients who are smokers and admitted to the hospital.
11118528|NCT01691105|FG001|Participant Flow|AD + Integrated Tobacco Order Set|"Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center~AD + Integrated Tobacco Order Set: Physician will have access to:~NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center"
11118529|NCT01691105|OG000|Outcome|Academic Detailing (AD)|Standard of care for patients who are smokers and admitted to the hospital.
11118530|NCT01691105|OG001|Outcome|AD + Integrated Tobacco Order Set|"Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center~AD + Integrated Tobacco Order Set: Physician will have access to:~NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center"
11118531|NCT01691105|EG000|Reported Event|Academic Detailing (AD)|Standard of care for patients who are smokers and admitted to the hospital.
11118532|NCT01691105|EG001|Reported Event|AD + Integrated Tobacco Order Set|"Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center~AD + Integrated Tobacco Order Set: Physician will have access to:~NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center"
11118533|NCT01691248|BG000|Baseline|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
11118534|NCT01691248|BG001|Baseline|Placebo|Placebo tablet once daily for no longer than 40 days
11118535|NCT01691248|BG002|Baseline|Total|Total of all reporting groups
11118536|NCT01691248|FG000|Participant Flow|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
11118537|NCT01691248|FG001|Participant Flow|Placebo|Placebo tablet once daily for no longer than 40 days
11118538|NCT01691248|OG000|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
11118539|NCT01691248|OG001|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
11118540|NCT01691248|EG000|Reported Event|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
11118541|NCT01691248|EG001|Reported Event|Placebo|Placebo tablet once daily for no longer than 40 days
11118542|NCT01691313|BG000|Baseline|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
11118543|NCT01691313|BG001|Baseline|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
11118544|NCT01691313|BG002|Baseline|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
11118545|NCT01691313|BG003|Baseline|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
11118546|NCT01691313|BG004|Baseline|Total|Total of all reporting groups
11118547|NCT01691313|FG000|Participant Flow|Vanoxerine 200mg|"vanoxerine 200 mg (2x 100mg oral capsules)~Vanoxerine: single oral dose"
11118548|NCT01691313|FG001|Participant Flow|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
11118549|NCT01691313|FG002|Participant Flow|Vanoxerine 300mg|vanoxerine 300 mg (3x 100 mg oral capsules) single oral dose
11118550|NCT01691313|FG003|Participant Flow|Vanoxerine 400mg|vanoxerine 400 mg (4x100mg oral capsules) single oral dose
11118551|NCT01691313|OG000|Outcome|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
11118552|NCT01691313|OG001|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
11118553|NCT01691313|OG002|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
11118554|NCT01691313|OG003|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
11118555|NCT01691313|EG000|Reported Event|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
11118556|NCT01691313|EG001|Reported Event|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
11118557|NCT01691313|EG002|Reported Event|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
11118558|NCT01691313|EG003|Reported Event|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
11118559|NCT01691326|BG000|Baseline|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
11118560|NCT01691326|BG001|Baseline|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
11118561|NCT01691326|BG002|Baseline|Total|Total of all reporting groups
11118562|NCT01691326|FG000|Participant Flow|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
11118563|NCT01691326|FG001|Participant Flow|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses 0.5 mL of Fluzone vaccine
11118564|NCT01691326|OG000|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
11118565|NCT01691326|OG001|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
11118566|NCT01691326|OG000|Outcome|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
11118567|NCT01691326|OG001|Outcome|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
11118568|NCT01691326|EG000|Reported Event|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
11118569|NCT01691326|EG001|Reported Event|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
11118570|NCT01691339|BG000|Baseline|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
11118571|NCT01691339|BG001|Baseline|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
11118572|NCT01691339|BG002|Baseline|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
11118573|NCT01691339|BG003|Baseline|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
11118574|NCT01691339|BG004|Baseline|Total|Total of all reporting groups
11118575|NCT01691339|FG000|Participant Flow|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
11118576|NCT01691339|FG001|Participant Flow|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
11118577|NCT01691339|FG002|Participant Flow|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
11118578|NCT01691339|FG003|Participant Flow|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
11118579|NCT01691339|OG000|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
11118580|NCT01691339|OG001|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
11118581|NCT01691339|OG002|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
11118582|NCT01691339|OG003|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
11118583|NCT01691339|EG000|Reported Event|Fluzone Vaccine (Group 1)|'Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly'
11118584|NCT01691339|EG001|Reported Event|Fluzone Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
11118585|NCT01691339|EG002|Reported Event|Fluzone Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
11118586|NCT01691339|EG003|Reported Event|Fluzone High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
11118587|NCT01691378|BG000|Baseline|WtoH Intervention|Window to Hope: Psychotherapy consists of 10 2-hour sessions for a maximum dose delivered of 20 hours. Therapy consists of small groups of up to 2 participants.
11118588|NCT01691378|BG001|Baseline|Waitlist Control|"Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment, 3 months after Time 1 baseline.~Waitlist Control arm baseline values reported from the Time 1 assessment"
11118589|NCT01691378|BG002|Baseline|Total|Total of all reporting groups
11118590|NCT01691378|FG000|Participant Flow|WtoH Intervention|Window to Hope: Psychotherapy consists of 10 2-hour sessions for a maximum dose delivered of 20 hours. Therapy consists of small groups of up to 2 participants.
11118591|NCT01691378|FG001|Participant Flow|Waitlist Control|Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment, 3 months after Time 1 baseline.
11118592|NCT01691378|OG000|Outcome|WtoH Intervention|Window to Hope: Psychotherapy consists of 10 2-hour sessions for a maximum dose delivered of 20 hours. Therapy consists of small groups of up to 2 participants.
11118593|NCT01691378|OG001|Outcome|Waitlist Control|Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment.
11118594|NCT01691378|EG000|Reported Event|WtoH Intervention|Window to Hope: Psychotherapy consists of 10 2-hour sessions for a maximum dose delivered of 20 hours. Therapy consists of small groups of up to 2 participants.
11118595|NCT01691378|EG001|Reported Event|Waitlist Control|Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment, 3 months after Time 1 baseline.
11118596|NCT01691430|BG000|Baseline|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
11118597|NCT01691430|BG001|Baseline|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
11118598|NCT01691430|BG002|Baseline|Total|Total of all reporting groups
11118599|NCT01691430|FG000|Participant Flow|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
11118600|NCT01691430|FG001|Participant Flow|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
11118601|NCT01691430|OG000|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
11118602|NCT01691430|OG001|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
11118603|NCT01691430|EG000|Reported Event|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
11118604|NCT01691430|EG001|Reported Event|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
11118605|NCT01691482|BG000|Baseline|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
11118606|NCT01691482|FG000|Participant Flow|A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2|Participants received albuterol (4 puffs; 90 micrograms [µg] per puff)/salbutamol (A/S) (4 puffs; 100 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via a metered-dose inhaler (MDI) during treatment period 1 (TP1) then, ipratropium followed by A/S at the same doses via an MDI in treatment period 2 (TP2).
11118607|NCT01691482|FG001|Participant Flow|Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2|Participants received Ipratropium (4 puffs; 20 µg per puff) followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) (A/S) via a MDI in TP1, then A/S followed by ipratropium at the same doses via an MDI in TP2.
11118608|NCT01691482|OG000|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
11118609|NCT01691482|OG001|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
11118610|NCT01691482|OG000|Outcome|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
11118611|NCT01691482|OG001|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
11118612|NCT01691482|EG000|Reported Event|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
11118613|NCT01691508|BG000|Baseline|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118614|NCT01691508|BG001|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118615|NCT01691508|BG002|Baseline|Total|Total of all reporting groups
11118616|NCT01691508|FG000|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118617|NCT01691508|FG001|Participant Flow|Mepolizumab 100mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118618|NCT01691508|OG000|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118619|NCT01691508|OG001|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118620|NCT01691508|EG000|Reported Event|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118621|NCT01691508|EG001|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118622|NCT01691521|BG000|Baseline|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118623|NCT01691521|BG001|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11126811|NCT01735916|FG001|Participant Flow|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
11118624|NCT01691521|BG002|Baseline|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118625|NCT01691521|BG003|Baseline|Total|Total of all reporting groups
11118626|NCT01691521|FG000|Participant Flow|Placebo|Participants received placebo intravenously (IV) plus placebo subcutaneously (SC) every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118627|NCT01691521|FG001|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118628|NCT01691521|FG002|Participant Flow|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118629|NCT01691521|OG000|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118630|NCT01691521|OG001|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118631|NCT01691521|OG002|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118632|NCT01691521|OG002|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
11118633|NCT01691521|EG000|Reported Event|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118634|NCT01691521|EG001|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
11118635|NCT01691521|EG002|Reported Event|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
10878690|NCT00453986|BG004|Baseline|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
10878691|NCT00453986|BG005|Baseline|Total|Total of all reporting groups
10878692|NCT00453986|FG000|Participant Flow|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
11118636|NCT01691534|BG000|Baseline|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118637|NCT01691534|BG001|Baseline|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
11118638|NCT01691534|BG002|Baseline|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118639|NCT01691534|BG003|Baseline|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118640|NCT01691534|BG004|Baseline|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
11118641|NCT01691534|BG005|Baseline|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
11118642|NCT01691534|BG006|Baseline|Rifafour|Rifafour on Days 1 to 14, dosed by weight
11118643|NCT01691534|BG007|Baseline|Total|Total of all reporting groups
11118644|NCT01691534|FG000|Participant Flow|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118645|NCT01691534|FG001|Participant Flow|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
11118646|NCT01691534|FG002|Participant Flow|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118647|NCT01691534|FG003|Participant Flow|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118648|NCT01691534|FG004|Participant Flow|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
11118649|NCT01691534|FG005|Participant Flow|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
11118650|NCT01691534|FG006|Participant Flow|Rifafour|Rifafour on Days 1 to 14, dosed by weight
11118651|NCT01691534|OG000|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118652|NCT01691534|OG001|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
11118653|NCT01691534|OG002|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118654|NCT01691534|OG003|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118655|NCT01691534|OG004|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
11118656|NCT01691534|OG005|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
11118657|NCT01691534|OG006|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
11118658|NCT01691534|OG005|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-1414
11118659|NCT01691534|EG000|Reported Event|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118660|NCT01691534|EG001|Reported Event|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
11118661|NCT01691534|EG002|Reported Event|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118662|NCT01691534|EG003|Reported Event|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
11118663|NCT01691534|EG004|Reported Event|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
11118664|NCT01691534|EG005|Reported Event|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
10878693|NCT00453986|FG001|Participant Flow|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
11118665|NCT01691534|EG006|Reported Event|Rifafour|Rifafour on Days 1 to 14, dosed by weight
11118666|NCT01691560|BG000|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
11118667|NCT01691560|BG001|Baseline|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
11118668|NCT01691560|BG002|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
11118669|NCT01691560|BG003|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
11118670|NCT01691560|BG004|Baseline|Total|Total of all reporting groups
11118671|NCT01691560|FG000|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate
11118672|NCT01691560|FG001|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
11118673|NCT01691560|FG002|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
11118674|NCT01691560|FG003|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
11118675|NCT01691560|OG000|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
11118676|NCT01691560|OG001|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
11118677|NCT01691560|OG002|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
11118678|NCT01691560|OG003|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
11118679|NCT01691560|EG000|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
11118680|NCT01691560|EG001|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
11118681|NCT01691560|EG002|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
11118682|NCT01691560|EG003|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
11118683|NCT01691612|BG000|Baseline|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
11118684|NCT01691612|FG000|Participant Flow|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
11118685|NCT01691612|OG000|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
11118686|NCT01691612|EG000|Reported Event|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
11118687|NCT01691690|BG000|Baseline|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11118688|NCT01691690|BG001|Baseline|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11118689|NCT01691690|BG002|Baseline|Total|Total of all reporting groups
11118690|NCT01691690|FG000|Participant Flow|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11118691|NCT01691690|FG001|Participant Flow|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11118692|NCT01691690|OG000|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11118693|NCT01691690|OG001|Outcome|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11118694|NCT01691690|OG001|Outcome|Saline Placebo Infused Intraoperatively|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11126812|NCT01735916|FG002|Participant Flow|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
10878694|NCT00453986|FG002|Participant Flow|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
11118695|NCT01691690|OG000|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction..~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg).~Midazolam: Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.~Sevoflurane: Sevoflurane for anesthesia induction.~Nitrous Oxide/Oxygen: Combination of NO2 & O2 for anesthesia induction.~Propofol: Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.~Morphine: Morphine 0.1 mg/kg given prior to intubation.~Ondansetron: Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.~Dexamethasone: Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis."
11118696|NCT01691690|OG001|Outcome|Saline Placebo Infused Intraoperatively|"For this arm Morphine will be administered to manage pain.~Normal Saline Flush: Saline placebo will be infused intraoperatively.~Midazolam: Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.~Sevoflurane: Sevoflurane for anesthesia induction.~Nitrous Oxide/Oxygen: Combination of NO2 & O2 for anesthesia induction.~Propofol: Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.~Morphine: Morphine 0.1 mg/kg given prior to intubation.~Ondansetron: Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.~Dexamethasone: Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis."
11118697|NCT01691690|EG000|Reported Event|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11118698|NCT01691690|EG001|Reported Event|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
11118699|NCT01691768|BG000|Baseline|Intervention|"1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118700|NCT01691768|BG001|Baseline|Control|"monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118701|NCT01691768|BG002|Baseline|Total|Total of all reporting groups
11118702|NCT01691768|FG000|Participant Flow|Intervention|"1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118703|NCT01691768|FG001|Participant Flow|Control|"monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118704|NCT01691768|OG000|Outcome|Intervention|"1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118705|NCT01691768|OG001|Outcome|Control|"monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118706|NCT01691768|OG000|Outcome|Intervention|"1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of Quality Improvement methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118707|NCT01691768|EG000|Reported Event|Intervention|"1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118708|NCT01691768|EG001|Reported Event|Control|"monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics~1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
11118709|NCT01691781|BG000|Baseline|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
11118710|NCT01691781|BG001|Baseline|Normals|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
11118711|NCT01691781|BG002|Baseline|Total|Total of all reporting groups
11118712|NCT01691781|FG000|Participant Flow|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
11118713|NCT01691781|FG001|Participant Flow|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
11118714|NCT01691781|OG000|Outcome|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
11118715|NCT01691781|OG001|Outcome|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
11118716|NCT01691781|EG000|Reported Event|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
11118717|NCT01691781|EG001|Reported Event|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
11118718|NCT01691794|BG000|Baseline|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118719|NCT01691794|BG001|Baseline|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118720|NCT01691794|BG002|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118721|NCT01691794|BG003|Baseline|Total|Total of all reporting groups
11118722|NCT01691794|FG000|Participant Flow|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118723|NCT01691794|FG001|Participant Flow|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118724|NCT01691794|FG002|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118725|NCT01691794|OG000|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118726|NCT01691794|OG001|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118727|NCT01691794|OG002|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118728|NCT01691794|EG000|Reported Event|B/L Weight 15 to Less Than 20 kg|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118729|NCT01691794|EG001|Reported Event|B/L Weight 20 to Less Than 40 kg|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118730|NCT01691794|EG002|Reported Event|B/L Weight Greater Than and Equal 40 kg|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
11118731|NCT01691820|BG000|Baseline|Group S+|CMV seropositive subjects, aged 10-17 years at enrollment in the study.
11118732|NCT01691820|BG001|Baseline|Group S-|CMV seronegative subjects, aged 10-17 years at enrollment in the study.
11118733|NCT01691820|BG002|Baseline|Total|Total of all reporting groups
11118734|NCT01691820|FG000|Participant Flow|Group S+|Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.
11118735|NCT01691820|FG001|Participant Flow|Group S-|Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.
11118736|NCT01691820|OG000|Outcome|Group S+|CMV seropositive subjects aged between 10-17 years at enrollment in the study.
11118737|NCT01691820|OG000|Outcome|Group S+|CMV seropositive subjects aged between 10-17 years at enrolment in the study.
11118738|NCT01691820|OG000|Outcome|Group S+|CMV seropositive subjects, aged between 10-17 years at enrollment in the study.
11118739|NCT01691820|OG000|Outcome|Group S+|CCMV seropositive subjects aged between 10-17 years at enrollment in the study.
11118740|NCT01691820|OG000|Outcome|Group S+|CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.
11118741|NCT01691820|OG000|Outcome|Group S-|CMV seronegative subjects, aged between 10-17 years at enrollment in the study.
11118742|NCT01691820|EG000|Reported Event|Group S+|CMV seropositive subjects aged 10-17 years at enrollment in the study.
11118743|NCT01691820|EG001|Reported Event|Group S-|CMV seronegative subjects aged 10-17 years at enrollment in the study.
11118744|NCT01691833|BG000|Baseline|Vitamin D|"Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.~Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D."
11118745|NCT01691833|BG001|Baseline|Placebo|"Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.~Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D."
11118746|NCT01691833|BG002|Baseline|Normovitaminosis|Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
11118747|NCT01691833|BG003|Baseline|Total|Total of all reporting groups
11118748|NCT01691833|FG000|Participant Flow|Hypovitaminosis- Vitamin D Group|"Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.~Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D."
11118749|NCT01691833|FG001|Participant Flow|Hypovitaminosis- Placebo Group|"Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.~Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D."
11118750|NCT01691833|FG002|Participant Flow|Normovitaminosis|Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
11118751|NCT01691833|OG000|Outcome|Hypovitaminosis- Vitamin D Group|"Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.~Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D."
11118752|NCT01691833|OG001|Outcome|Hypovitaminosis- Placebo Group|"Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.~Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D."
11118753|NCT01691833|OG002|Outcome|Normovitaminosis|Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
11118754|NCT01691833|EG000|Reported Event|Hypovitaminosis- Vitamin D Group|"Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.~Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D."
11118755|NCT01691833|EG001|Reported Event|Hypovitaminosis- Placebo Group|"Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.~Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D."
11118756|NCT01691833|EG002|Reported Event|Normovitaminosis|Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
11118757|NCT01691859|BG000|Baseline|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
11118758|NCT01691859|FG000|Participant Flow|Mepolizumab 100 mg|Participants received 100 milligram (mg) of mepolizumab injected subcutaneously (SC) once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
11005794|NCT01082874|BG000|Baseline|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005795|NCT01082874|BG001|Baseline|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005796|NCT01082874|BG002|Baseline|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005797|NCT01082874|BG003|Baseline|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005798|NCT01082874|BG004|Baseline|Total|Total of all reporting groups
11005799|NCT01082874|FG000|Participant Flow|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005800|NCT01082874|FG001|Participant Flow|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005801|NCT01082874|FG002|Participant Flow|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005802|NCT01082874|FG003|Participant Flow|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005803|NCT01082874|OG000|Outcome|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005804|NCT01082874|OG001|Outcome|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005805|NCT01082874|OG002|Outcome|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005806|NCT01082874|OG003|Outcome|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005807|NCT01082874|EG000|Reported Event|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005808|NCT01082874|EG001|Reported Event|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005809|NCT01082874|EG002|Reported Event|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11118759|NCT01691859|OG000|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
11118760|NCT01691859|EG000|Reported Event|Mepolizumab|Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.
11118761|NCT01691885|BG000|Baseline|Per Protocol Population|All participants received placebo or FF/VI 100/25 µg in either of the two treatment periods QD, each morning from a DPI. Treatment periods lasted 7 days up to a maximum of 14 days for each period. The two treatments were separated by a wash out period of 7 days, up to a maximum of 9 days.
11118762|NCT01691885|FG000|Participant Flow|Placebo Then FF/VI|Participants entering Treatment Period 1 received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period participants entered Treatment Period 2 and received Fluticasone Furoate/Vilanerol (FF/VI) 100/25 micrograms (µg), QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
11118763|NCT01691885|FG001|Participant Flow|FF/VI Then Placebo|Participants entering Treatment Period 1 received FF/VI 100/25 µg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period, participants entered Treatment Period 2 and received matching placebo QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
11118764|NCT01691885|OG000|Outcome|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
11118765|NCT01691885|OG001|Outcome|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
11118766|NCT01691885|EG000|Reported Event|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
11118767|NCT01691885|EG001|Reported Event|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
11118768|NCT01691898|BG000|Baseline|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with relapsed or refractory [r/r] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118769|NCT01691898|BG001|Baseline|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118770|NCT01691898|BG002|Baseline|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
11118771|NCT01691898|BG003|Baseline|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
10878695|NCT00453986|FG003|Participant Flow|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
11118772|NCT01691898|BG004|Baseline|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118773|NCT01691898|BG005|Baseline|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118774|NCT01691898|BG006|Baseline|Total|Total of all reporting groups
11118775|NCT01691898|FG000|Participant Flow|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with relapsed or refractory (r/r) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118776|NCT01691898|FG001|Participant Flow|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118777|NCT01691898|FG002|Participant Flow|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
11118778|NCT01691898|FG003|Participant Flow|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118779|NCT01691898|FG004|Participant Flow|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118780|NCT01691898|FG005|Participant Flow|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118781|NCT01691898|OG000|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118782|NCT01691898|OG001|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118783|NCT01691898|OG002|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118784|NCT01691898|OG003|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118785|NCT01691898|OG004|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
11118786|NCT01691898|OG000|Outcome|Cohort E (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118787|NCT01691898|OG001|Outcome|Cohort E (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118788|NCT01691898|OG002|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118789|NCT01691898|OG003|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118790|NCT01691898|OG000|Outcome|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118791|NCT01691898|OG001|Outcome|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118792|NCT01691898|OG002|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
11118793|NCT01691898|OG003|Outcome|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118794|NCT01691898|OG004|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118795|NCT01691898|OG005|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118796|NCT01691898|OG000|Outcome|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118797|NCT01691898|OG001|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118798|NCT01691898|OG002|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118799|NCT01691898|OG000|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118800|NCT01691898|OG001|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118801|NCT01691898|OG000|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118802|NCT01691898|OG001|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118803|NCT01691898|OG000|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
11118804|NCT01691898|OG001|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11126813|NCT01735916|OG000|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
11126814|NCT01735916|OG001|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
11118805|NCT01691898|EG000|Reported Event|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with relapsed or refractory [r/r] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118806|NCT01691898|EG001|Reported Event|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
11118807|NCT01691898|EG002|Reported Event|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
11118808|NCT01691898|EG003|Reported Event|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118809|NCT01691898|EG004|Reported Event|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118810|NCT01691898|EG005|Reported Event|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
11118811|NCT01691950|BG000|Baseline|Reconstruction|Those who have undergone limb reconstruction following lower limb trauma
11118812|NCT01691950|BG001|Baseline|Control|Healthy volunteers
11118813|NCT01691950|BG002|Baseline|Total|Total of all reporting groups
11118814|NCT01691950|FG000|Participant Flow|Reconstruction|Those who have undergone limb reconstruction following lower limb trauma
11118815|NCT01691950|FG001|Participant Flow|Control|Healthy volunteers
11118816|NCT01691950|OG000|Outcome|Reconstruction|Those who have undergone limb reconstruction following lower limb trauma
11118817|NCT01691950|OG001|Outcome|Control|Healthy volunteers
11118818|NCT01691950|EG000|Reported Event|Reconstruction|Those who have undergone limb reconstruction following lower limb trauma
11118819|NCT01691950|EG001|Reported Event|Control|Healthy volunteers
11118820|NCT01692119|BG000|Baseline|Regular, Pharmacy-based Intervention|"providing medication in weekly dosing aids and regular contacts with the local pharmacy~Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:~Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.~Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician."
11118821|NCT01692119|BG001|Baseline|Usual Care|usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
11118822|NCT01692119|BG002|Baseline|Total|Total of all reporting groups
11118823|NCT01692119|FG000|Participant Flow|Regular, Pharmacy-based Intervention|"providing medication in weekly dosing aids and regular contacts with the local pharmacy~Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:~Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.~Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician."
11118824|NCT01692119|FG001|Participant Flow|Usual Care|usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
11118825|NCT01692119|OG000|Outcome|Regular, Pharmacy-based Intervention|"providing medication in weekly dosing aids and regular contacts with the local pharmacy~Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:~Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.~Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician."
11118826|NCT01692119|OG001|Outcome|Usual Care|usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
11118827|NCT01692119|EG000|Reported Event|Regular, Pharmacy-based Intervention|"providing medication in weekly dosing aids and regular contacts with the local pharmacy~Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:~Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.~Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician."
11118828|NCT01692119|EG001|Reported Event|Usual Care|usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
11118829|NCT01692197|BG000|Baseline|E7070 and Idarubicin and Cytarabine|"E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:~Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).~Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days)."
11118830|NCT01692197|FG000|Participant Flow|E7070 and Idarubicin and Cytarabine|"E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:~Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).~Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days)."
11118831|NCT01692197|OG000|Outcome|E7070 and Idarubicin and Cytarabine|"E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:~Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).~Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days)."
11118832|NCT01692197|OG000|Outcome|E7070 + Idarubicin + Cytarabine|"E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.~E7070: 400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.~Idarubicin: 8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).~Cytarabine: 1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).~Dexamethasone: 10 mg by vein daily for 3 - 4 days with cytarabine."
11118833|NCT01692197|EG000|Reported Event|E7070 and Idarubicin and Cytarabine|"E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:~Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).~Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days)."
11118834|NCT01692275|BG000|Baseline|Site: WRNMMC - UMC|"Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118835|NCT01692275|BG001|Baseline|Site: WRNMMC - UMC + Chiropractic Care|"Site: Walter Reed National Military Medical Center (WR)~Medical care (UMC) plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118836|NCT01692275|BG002|Baseline|Site: NHP - UMC|"Site: Naval Hospital Pensacola~Conventional medical care only/Usual Medical Care (UMC)~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118837|NCT01692275|BG003|Baseline|Site: NHP - UMC + Chiropractic Care|"Site: Naval Hospital Pensacola~Medical care (UMC) plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11126815|NCT01735916|EG000|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
11118838|NCT01692275|BG004|Baseline|Site: NMCSD - UMC|"Site: Naval Medical Center San Diego~Conventional medical care only/Usual Medical Care (UMC)~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118839|NCT01692275|BG005|Baseline|Site: NMCSD - UMC + Chiropractic Care|"Site: Naval Medical Center San Diego~Medical care (UMC) plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118840|NCT01692275|BG006|Baseline|Total|Total of all reporting groups
11118841|NCT01692275|FG000|Participant Flow|Medical Care + Chiropractic Care|"Medical care plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118842|NCT01692275|FG001|Participant Flow|Conventional Medical Care Only|"Conventional medical care only~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118843|NCT01692275|OG000|Outcome|Site: WRNMMC - UMC|"Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118844|NCT01692275|OG001|Outcome|Site: WRNMMC - UMC + Chiropractic Care|"Site: Walter Reed National Military Medical Center (WR)~Medical care (UMC) plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118845|NCT01692275|OG002|Outcome|Site: NHP - UMC|"Site: Naval Hospital Pensacola~Conventional medical care only/Usual Medical Care (UMC)~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118846|NCT01692275|OG003|Outcome|Site: NHP - UMC + Chiropractic Care|"Site: Naval Hospital Pensacola~Medical care (UMC) plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118847|NCT01692275|OG004|Outcome|Site: NMCSD - UMC|"Site: Naval Medical Center San Diego~Conventional medical care only/Usual Medical Care (UMC)~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118848|NCT01692275|OG005|Outcome|Site: NMCSD - UMC + Chiropractic Care|"Site: Naval Medical Center San Diego~Medical care (UMC) plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118849|NCT01692275|OG000|Outcome|WR - UMC|Walter Reed National Military Medical Center (WR) - Usual Medical Care
11118850|NCT01692275|OG001|Outcome|WR - UMC + CC|Walter Reed National Military Medical Center - Usual Medical Care + Chiropractic Care group
11118851|NCT01692275|OG002|Outcome|Pensacola - UMC|Naval Hospital Pensacola - Usual Medical Care group
11118852|NCT01692275|OG003|Outcome|Pensacola - UMC + CC|Naval Hospital Pensacola - Usual Medical Care + Chiropractic Care group
11118853|NCT01692275|OG004|Outcome|San Diego - UMC|Naval Medical Center San Diego - Usual Medical Care group
11118854|NCT01692275|OG005|Outcome|San Diego - UMC + CC|Naval Medical Center San Diego - Usual Medical Care + Chiropractic Care group
11118855|NCT01692275|OG006|Outcome|All Sites - UMC|"All 3 sites combined (WRNMMC, NHP, NMCSD)~Conventional medical care only/Usual Medical Care (UMC)~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118856|NCT01692275|OG007|Outcome|All Sites Combined - UMC + Chiropractic Care|"All 3 sites combined (WRNMMC, NHP, NMCSD)~Medical care (UMC) plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118857|NCT01692275|EG000|Reported Event|Usual Medical Care|"Conventional medical care only/usual medical care (UMC)~Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
11118858|NCT01692275|EG001|Reported Event|UMC + Chiropractic Care|"Medical care plus chiropractic manipulative therapy~Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic."
10846074|NCT00272961|BG003|Baseline|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
11118859|NCT01692301|BG000|Baseline|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
11118860|NCT01692301|BG001|Baseline|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
11118861|NCT01692301|BG002|Baseline|Total|Total of all reporting groups
11118862|NCT01692301|FG000|Participant Flow|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
11118863|NCT01692301|FG001|Participant Flow|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
11118864|NCT01692301|OG000|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
11118865|NCT01692301|OG001|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
11118866|NCT01692301|EG000|Reported Event|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
11118867|NCT01692301|EG001|Reported Event|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
11118868|NCT01692340|BG000|Baseline|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118869|NCT01692340|BG001|Baseline|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118870|NCT01692340|BG002|Baseline|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118871|NCT01692340|BG003|Baseline|Total|Total of all reporting groups
11118872|NCT01692340|FG000|Participant Flow|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118873|NCT01692340|FG001|Participant Flow|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118874|NCT01692340|FG002|Participant Flow|Istotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118875|NCT01692340|OG000|Outcome|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118876|NCT01692340|OG001|Outcome|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118877|NCT01692340|OG000|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118878|NCT01692340|OG001|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118879|NCT01692340|OG002|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118880|NCT01692340|EG000|Reported Event|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118881|NCT01692340|EG001|Reported Event|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
11118882|NCT01692496|BG000|Baseline|Pazopanib|"Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision.~Pazopanib: Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision."
11118883|NCT01692496|FG000|Participant Flow|Pazopanib|"Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision.~Pazopanib: Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision."
11118884|NCT01692496|OG000|Outcome|Pazopanib|"Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision.~Pazopanib: Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision."
11118885|NCT01692496|EG000|Reported Event|Pazopanib|"Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision.~Pazopanib: Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision."
11118886|NCT01692626|BG000|Baseline|Investigational Cream/Placebo Cream|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
11118887|NCT01692626|FG000|Participant Flow|Left Side Investigational Cream/Placebo Cream on Right Side|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
11118888|NCT01692626|FG001|Participant Flow|Right Side Investigational Cream / Placebo on Left Side|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
11118889|NCT01692626|OG000|Outcome|Left sidePimecrolimus Cream|The left side of the face that the Pimecrolimus Cream was applied.
11118890|NCT01692626|OG001|Outcome|The Right Side the Pimecrolimus Cream|The right side of the face that the pimecrolimus cream was applied.
11118891|NCT01692626|EG000|Reported Event|Investigational Cream/Placebo Cream|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
11118892|NCT01692730|BG000|Baseline|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
11118893|NCT01692730|BG001|Baseline|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
11118894|NCT01692730|BG002|Baseline|Total|Total of all reporting groups
11118895|NCT01692730|FG000|Participant Flow|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
11118896|NCT01692730|FG001|Participant Flow|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
11118897|NCT01692730|OG000|Outcome|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
11118898|NCT01692730|OG001|Outcome|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
11118899|NCT01692730|EG000|Reported Event|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
11118900|NCT01692730|EG001|Reported Event|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
11118901|NCT01692743|BG000|Baseline|Standard of Care|Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
11118902|NCT01692743|BG001|Baseline|Weekly Home Monitoring|"Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.~Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met."
11118903|NCT01692743|BG002|Baseline|Home Monitoring Every Other Week|"Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.~Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met."
11118904|NCT01692743|BG003|Baseline|Total|Total of all reporting groups
11118905|NCT01692743|FG000|Participant Flow|Standard of Care|Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
11118906|NCT01692743|FG001|Participant Flow|Weekly Home Monitoring|"Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.~Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met."
11118907|NCT01692743|FG002|Participant Flow|Home Monitoring Every Other Week|"Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.~Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met."
11118908|NCT01692743|OG000|Outcome|Standard of Care|Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
11118909|NCT01692743|OG001|Outcome|Weekly Home Monitoring|"Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.~Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met."
11118910|NCT01692743|OG002|Outcome|Home Monitoring Every Other Week|"Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.~Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met."
11118911|NCT01692743|EG000|Reported Event|Standard of Care|Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
11126816|NCT01735916|EG001|Reported Event|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
11126817|NCT01735916|EG002|Reported Event|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
11118912|NCT01692743|EG001|Reported Event|Weekly Home Monitoring|"Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.~Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met."
11118913|NCT01692743|EG002|Reported Event|Home Monitoring Every Other Week|"Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.~Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met."
11348353|NCT04179461|OG000|Outcome|Personalized Treatment|"Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.~Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.~Cholecalciferol: Oral administration~antihistamine: Oral administration~Azithromycin: Oral administration~emollient cream: Topical~Fluticasone Propionate: Nasal spray~Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."
11348354|NCT04179461|EG000|Reported Event|Personalized Treatment|"Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.~Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.~Cholecalciferol: Oral administration~antihistamine: Oral administration~Azithromycin: Oral administration~emollient cream: Topical~Fluticasone Propionate: Nasal spray~Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."
11348355|NCT04179474|BG000|Baseline|Part 1 (Intervention A Then B Then D)|Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11348356|NCT04179474|BG001|Baseline|Part 2 (Intervention A Then C Then D)|Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11348357|NCT04179474|BG002|Baseline|Total|Total of all reporting groups
11348358|NCT04179474|FG000|Participant Flow|Part 1 (Intervention A Then B Then D)|Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11348359|NCT04179474|FG001|Participant Flow|Part 2 (Intervention A Then C Then D)|Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11348360|NCT04179474|OG000|Outcome|Part 1: Ubrogepant Alone|Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
11348361|NCT04179474|OG001|Outcome|Part 1: Ubrogepant in Combination With Erenumab|Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
11348362|NCT04179474|OG000|Outcome|Part 2: Ubrogepant Alone|Participants received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
11348363|NCT04179474|OG001|Outcome|Part 2: Ubrogepant in Combination With Galcanezumab|Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
11348364|NCT04179474|OG000|Outcome|Part 2: Ubrogepant Alone|Participant received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasting conditions.
11118914|NCT01692756|BG000|Baseline|Kenalog or Placebo|"Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.~Kenalog or placebo"
11118915|NCT01692756|BG001|Baseline|Kenalog Then Placebo|"Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.~Kenalog then Placebo"
11118916|NCT01692756|BG002|Baseline|Kenalog Only|"Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®~Kenalog"
11118917|NCT01692756|BG003|Baseline|Placebo|"subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.~Placebo"
11118918|NCT01692756|BG004|Baseline|Total|Total of all reporting groups
11118919|NCT01692756|FG000|Participant Flow|Kenalog or Placebo|"Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.~Kenalog or placebo"
11118920|NCT01692756|FG001|Participant Flow|Kenalog Then Placebo|"Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.~Kenalog then Placebo"
11118921|NCT01692756|FG002|Participant Flow|Kenalog Only|"Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®~Kenalog"
11118922|NCT01692756|FG003|Participant Flow|Placebo|"subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.~Placebo"
11118923|NCT01692756|OG000|Outcome|Kenalog or Placebo|"Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.~Kenalog or placebo"
11118924|NCT01692756|OG001|Outcome|Kenalog Then Placebo|"Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.~Kenalog then Placebo"
11118925|NCT01692756|OG002|Outcome|Kenalog Only|"Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®~Kenalog"
11118926|NCT01692756|OG003|Outcome|Placebo|"subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.~Placebo"
11118927|NCT01692756|EG000|Reported Event|Kenalog or Placebo|"Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.~Kenalog or placebo"
11118928|NCT01692756|EG001|Reported Event|Kenalog Then Placebo|"Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.~Kenalog then Placebo"
11118929|NCT01692756|EG002|Reported Event|Kenalog Only|"Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®~Kenalog"
11118930|NCT01692756|EG003|Reported Event|Placebo|"subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.~Placebo"
11118931|NCT01692782|BG000|Baseline|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily"
11118932|NCT01692782|BG001|Baseline|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 8mg once daily"
11118933|NCT01692782|BG002|Baseline|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
11118934|NCT01692782|BG003|Baseline|Total|Total of all reporting groups
11118935|NCT01692782|FG000|Participant Flow|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
11118936|NCT01692782|FG001|Participant Flow|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
11118937|NCT01692782|FG002|Participant Flow|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
11118938|NCT01692782|OG000|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
11118939|NCT01692782|OG001|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
11118940|NCT01692782|OG002|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
11118941|NCT01692782|EG000|Reported Event|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
11118942|NCT01692782|EG001|Reported Event|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
11118943|NCT01692782|EG002|Reported Event|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
11118944|NCT01692938|BG000|Baseline|No Retinal Disease|
11118945|NCT01692938|BG001|Baseline|Retinal Disease|
11118946|NCT01692938|BG002|Baseline|Total|Total of all reporting groups
11118947|NCT01692938|FG000|Participant Flow|No Retinal Disease|
11118948|NCT01692938|FG001|Participant Flow|Retinal Disease|
11118949|NCT01692938|OG000|Outcome|No Retinal Disease|
11118950|NCT01692938|OG001|Outcome|Retinal Disease|
11118951|NCT01692938|EG000|Reported Event|No Retinal Disease|
11118952|NCT01692938|EG001|Reported Event|Retinal Disease|
11118953|NCT01692951|BG000|Baseline|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118954|NCT01692951|BG001|Baseline|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118955|NCT01692951|BG002|Baseline|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11126818|NCT01735981|BG000|Baseline|Dance Dance Revolution Exercise, Then Hand Held Video Game (Control)|Participants first completed the video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance. Then participated in a hand held video game as the control activity.
11118956|NCT01692951|BG003|Baseline|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118957|NCT01692951|BG004|Baseline|Total|Total of all reporting groups
11118958|NCT01692951|FG000|Participant Flow|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118959|NCT01692951|FG001|Participant Flow|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118960|NCT01692951|FG002|Participant Flow|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118961|NCT01692951|FG003|Participant Flow|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118962|NCT01692951|OG000|Outcome|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118963|NCT01692951|OG001|Outcome|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118964|NCT01692951|OG002|Outcome|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118965|NCT01692951|OG003|Outcome|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118966|NCT01692951|EG000|Reported Event|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118967|NCT01692951|EG001|Reported Event|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118968|NCT01692951|EG002|Reported Event|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118969|NCT01692951|EG003|Reported Event|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
11118970|NCT01692964|BG000|Baseline|InflammaDry|"Patients suspected of having dry eye will be tested with the InflammaDry.~InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears."
11118971|NCT01692964|FG000|Participant Flow|InflammaDry|"Patients suspected of having dry eye will be tested with the InflammaDry.~InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears."
11118972|NCT01692964|OG000|Outcome|InflammaDry (Sensitivity)|Looking for the percentage of true positives as compared to clinical assessment.
11348365|NCT04179474|OG000|Outcome|Part 1 (Intervention A Then B Then D)|Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11005810|NCT01082874|EG003|Reported Event|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
11005811|NCT01082939|BG000|Baseline|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
11005812|NCT01082939|FG000|Participant Flow|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
11005813|NCT01082939|OG000|Outcome|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
11005814|NCT01082939|EG000|Reported Event|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
11005815|NCT01082952|BG000|Baseline|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
11005816|NCT01082952|BG001|Baseline|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
11005817|NCT01082952|BG002|Baseline|Total|Total of all reporting groups
11005818|NCT01082952|FG000|Participant Flow|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
11005819|NCT01082952|FG001|Participant Flow|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
11005820|NCT01082952|OG000|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
11005821|NCT01082952|OG001|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
11005822|NCT01082952|EG000|Reported Event|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
11005823|NCT01082952|EG001|Reported Event|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
11005824|NCT01082965|BG000|Baseline|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
11005825|NCT01082965|BG001|Baseline|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
11005826|NCT01082965|BG002|Baseline|Total|Total of all reporting groups
11005827|NCT01082965|FG000|Participant Flow|Donepezil|Donepezil 5 milligram (mg) tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
11005828|NCT01082965|FG001|Participant Flow|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
11005829|NCT01082965|OG000|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
11005830|NCT01082965|OG001|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
11005831|NCT01082965|EG000|Reported Event|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
11005832|NCT01082965|EG001|Reported Event|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
11005833|NCT01083121|BG000|Baseline|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
11005834|NCT01083121|FG000|Participant Flow|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
11005835|NCT01083121|OG000|Outcome|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
11005836|NCT01083121|OG000|Outcome|Rheumatoid Arthritis|Participants with moderately to severely active rheumatoid arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
11005837|NCT01083121|OG001|Outcome|Psoriatic Arthritis|Participants with active and progressive psoriatic arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
11005838|NCT01083121|OG002|Outcome|Ankylosing Spondylitis|Participants with severe active ankylosing spondylitis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
11005839|NCT01083121|OG003|Outcome|Crohn's Disease|Participants with severely active Crohn's disease who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
11005840|NCT01083121|EG000|Reported Event|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
11005841|NCT01083160|BG000|Baseline|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
11005842|NCT01083160|FG000|Participant Flow|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
11118973|NCT01692964|OG001|Outcome|Inflammadry (Specificity)|Looking for the percentage of true negatives as compared to clinical assessment.
11118974|NCT01692964|EG000|Reported Event|InflammaDry|"Patients suspected of having dry eye will be tested with the InflammaDry.~InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears."
11118975|NCT01693029|BG000|Baseline|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
11118976|NCT01693029|BG001|Baseline|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
11118977|NCT01693029|BG002|Baseline|Total|Total of all reporting groups
11118978|NCT01693029|FG000|Participant Flow|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
11118979|NCT01693029|FG001|Participant Flow|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
11118980|NCT01693029|OG000|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
11118981|NCT01693029|OG001|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
11118982|NCT01693029|EG000|Reported Event|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
11118983|NCT01693029|EG001|Reported Event|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
11118984|NCT01693068|BG000|Baseline|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
11118985|NCT01693068|BG001|Baseline|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
11118986|NCT01693068|BG002|Baseline|Total|Total of all reporting groups
11118987|NCT01693068|FG000|Participant Flow|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
11118988|NCT01693068|FG001|Participant Flow|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
11118989|NCT01693068|FG002|Participant Flow|Pimasertib (Crossover)|Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
11118990|NCT01693068|OG000|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
11118991|NCT01693068|OG001|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
11118992|NCT01693068|OG002|Outcome|Pimasertib (Crossover)|Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
11118993|NCT01693068|EG000|Reported Event|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
11118994|NCT01693068|EG001|Reported Event|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
11118995|NCT01693068|EG002|Reported Event|Pimasertib (Crossover)|Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
11118996|NCT01693120|BG000|Baseline|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
11118997|NCT01693120|FG000|Participant Flow|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
11118998|NCT01693120|OG000|Outcome|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
11118999|NCT01693120|EG000|Reported Event|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
11119000|NCT01693185|BG000|Baseline|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
11119001|NCT01693185|BG001|Baseline|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
11119002|NCT01693185|BG002|Baseline|Total|Total of all reporting groups
11119003|NCT01693185|FG000|Participant Flow|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
11119004|NCT01693185|FG001|Participant Flow|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
11119005|NCT01693185|OG000|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
11119006|NCT01693185|OG001|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
11119007|NCT01693185|EG000|Reported Event|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
11119008|NCT01693185|EG001|Reported Event|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
11348366|NCT04179474|OG001|Outcome|Part 2 (Intervention A Then C Then D)|Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11348367|NCT04179474|OG000|Outcome|Part 1: Intervention A (Ubrogepant)|Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
11119009|NCT01693250|BG000|Baseline|Fitbit Ultra|"Adolescents in the intervention group will receive a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.~fitbit Ultra: Participants will be asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet."
11119010|NCT01693250|BG001|Baseline|Pedometer|"After completion of the baseline assessments, adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.~Pedometer: adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months."
11119011|NCT01693250|BG002|Baseline|Total|Total of all reporting groups
11119012|NCT01693250|FG000|Participant Flow|Fitbit Ultra|"A total of 23 adolescents in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.~fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet."
11119013|NCT01693250|FG001|Participant Flow|Pedometer|"A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.~Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months."
11119014|NCT01693250|OG000|Outcome|Fitbit Ultra|"Participants in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.~fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet."
11119015|NCT01693250|OG001|Outcome|Pedometer|"After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.~Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months."
11119016|NCT01693250|OG000|Outcome|Fitbit Ultra|"A total of 23 adolescents in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.~fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet."
11119017|NCT01693250|OG001|Outcome|Pedometer|"A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.~Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months."
11348368|NCT04179474|OG001|Outcome|Part 1: Intervention B (Erenumab)|Intervention B (erenumab 140 mg) single SC injection on Day 8.
11348369|NCT04179474|OG002|Outcome|Part 1: Intervention D (Ubrogepant)|Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11119018|NCT01693250|EG000|Reported Event|Fitbit Ultra|"A total of 23 adolescents in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.~fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet."
11119019|NCT01693250|EG001|Reported Event|Pedometer|"A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.~Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months."
11119020|NCT01693523|BG000|Baseline|Minocycline|"Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.~Minocycline: 100 mg by mouth two times a day (200 mg/day).~Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit."
11119021|NCT01693523|BG001|Baseline|Placebo|"Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.~Placebo: Matching placebo capsules by mouth twice a day.~Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit."
11119022|NCT01693523|BG002|Baseline|Observational|Non Intervention
11119023|NCT01693523|BG003|Baseline|Total|Total of all reporting groups
11119024|NCT01693523|FG000|Participant Flow|Minocycline|"Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.~Minocycline: 100 mg by mouth two times a day (200 mg/day).~Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit."
11119025|NCT01693523|FG001|Participant Flow|Placebo|"Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.~Placebo: Matching placebo capsules by mouth twice a day.~Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit."
11119026|NCT01693523|FG002|Participant Flow|Observational|No Intervention
11119027|NCT01693523|OG000|Outcome|Minocycline|"Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.~Minocycline: 100 mg by mouth two times a day (200 mg/day).~Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit."
11119028|NCT01693523|OG001|Outcome|Placebo|"Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.~Placebo: Matching placebo capsules by mouth twice a day.~Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit."
11119029|NCT01693523|OG002|Outcome|Observational|No Intervention
11119030|NCT01693523|EG000|Reported Event|Minocycline|"Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.~Minocycline: 100 mg by mouth two times a day (200 mg/day).~Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit."
11119031|NCT01693523|EG001|Reported Event|Placebo|"Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.~Placebo: Matching placebo capsules by mouth twice a day.~Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit."
11119032|NCT01693562|BG000|Baseline|Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)|Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119033|NCT01693562|BG001|Baseline|Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)|Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119034|NCT01693562|BG002|Baseline|Escalation Cohort (MEDI4736 1 mg/kg Q2W)|Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119035|NCT01693562|BG003|Baseline|Escalation Cohort (MEDI4736 3 mg/kg Q2W)|Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119036|NCT01693562|BG004|Baseline|Escalation Cohort (MEDI4736 10 mg/kg Q2W)|Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11348370|NCT04179474|OG003|Outcome|Part 2: Intervention A (Ubrogepant)|Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
11119037|NCT01693562|BG005|Baseline|Escalation Cohort (MEDI4736 15 mg/kg Q3W)|Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119038|NCT01693562|BG006|Baseline|Exploration Durvalumab 20 mg/kg (Q4W)|Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119039|NCT01693562|BG007|Baseline|Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119040|NCT01693562|BG008|Baseline|Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119041|NCT01693562|BG009|Baseline|Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119042|NCT01693562|BG010|Baseline|Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)|Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119043|NCT01693562|BG011|Baseline|Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119044|NCT01693562|BG012|Baseline|Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119045|NCT01693562|BG013|Baseline|Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119046|NCT01693562|BG014|Baseline|Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119047|NCT01693562|BG015|Baseline|Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119048|NCT01693562|BG016|Baseline|Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119049|NCT01693562|BG017|Baseline|Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119050|NCT01693562|BG018|Baseline|Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119051|NCT01693562|BG019|Baseline|Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)|Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119052|NCT01693562|BG020|Baseline|Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11348371|NCT04179474|OG004|Outcome|Part 2: Intervention C (Galcanezumab)|Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
11348372|NCT04179474|OG005|Outcome|Part 2: Intervention D (Ubrogepant)|Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11119053|NCT01693562|BG021|Baseline|Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)|Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119054|NCT01693562|BG022|Baseline|Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119055|NCT01693562|BG023|Baseline|Total|Total of all reporting groups
11119056|NCT01693562|FG000|Participant Flow|Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)|Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119057|NCT01693562|FG001|Participant Flow|Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)|Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119058|NCT01693562|FG002|Participant Flow|Escalation Cohort (MEDI4736 1 mg/kg Q2W)|Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119059|NCT01693562|FG003|Participant Flow|Escalation Cohort (MEDI4736 3 mg/kg Q2W)|Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119060|NCT01693562|FG004|Participant Flow|Escalation Cohort (MEDI4736 10 mg/kg Q2W)|Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119061|NCT01693562|FG005|Participant Flow|Escalation Cohort (MEDI4736 15 mg/kg Q3W)|Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119062|NCT01693562|FG006|Participant Flow|Exploration Durvalumab 20 mg/kg (Q4W)|Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119063|NCT01693562|FG007|Participant Flow|Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119064|NCT01693562|FG008|Participant Flow|Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119065|NCT01693562|FG009|Participant Flow|Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119066|NCT01693562|FG010|Participant Flow|Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)|Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119067|NCT01693562|FG011|Participant Flow|Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11348373|NCT04179474|EG000|Reported Event|Part 1: Intervention A (Ubrogepant)|Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
11119068|NCT01693562|FG012|Participant Flow|Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11348374|NCT04179474|EG001|Reported Event|Part 1: Intervention B (Erenumab)|Intervention B (erenumab 140 mg) single SC injection on Day 8.
11348375|NCT04179474|EG002|Reported Event|Part 1: Intervention D (Ubrogepant)|Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11348376|NCT04179474|EG003|Reported Event|Part 2; Intervention A (Ubrogepant)|Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
11119069|NCT01693562|FG013|Participant Flow|Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119070|NCT01693562|FG014|Participant Flow|Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119071|NCT01693562|FG015|Participant Flow|Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119072|NCT01693562|FG016|Participant Flow|Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119073|NCT01693562|FG017|Participant Flow|Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119074|NCT01693562|FG018|Participant Flow|Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119075|NCT01693562|FG019|Participant Flow|Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)|Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119076|NCT01693562|FG020|Participant Flow|Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119077|NCT01693562|FG021|Participant Flow|Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)|Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119078|NCT01693562|FG022|Participant Flow|Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119079|NCT01693562|OG000|Outcome|Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)|Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119080|NCT01693562|OG001|Outcome|Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)|Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first
11119081|NCT01693562|OG002|Outcome|Escalation Cohort (MEDI4736 1 mg/kg Q2W)|Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119082|NCT01693562|OG003|Outcome|Escalation Cohort (MEDI4736 3 mg/kg Q2W)|Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
11119083|NCT01693562|OG004|Outcome|Escalation Cohort (MEDI4736 10 mg/kg Q2W)|Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
11119084|NCT01693562|OG005|Outcome|Escalation Cohort (MEDI4736 15 mg/kg Q3W)|Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119085|NCT01693562|OG004|Outcome|Escalation Cohort (MEDI4736 15 mg/kg Q3W)|Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119086|NCT01693562|OG005|Outcome|Exploration Cohort (MEDI4736 20 mg/kg Q4W)|Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119087|NCT01693562|OG006|Outcome|Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)|Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
11119088|NCT01693562|OG000|Outcome|Expansion Non-squamous NSCLC 3L+ Cohort|Participants with non-squamous NSCLC who had received 2 or more lines of prior therapy (3L+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119089|NCT01693562|OG000|Outcome|Expansion Squamous NSCLC 2L+ Cohort|Participants with squamous NSCLC who had received at least 1 line of prior therapy (2L+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119090|NCT01693562|OG001|Outcome|Expansion Squamous NSCLC 3L+ Cohort|Participants with squamous NSCLC who had received 2 or more lines of prior therapy (3L+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119091|NCT01693562|OG000|Outcome|Expansion UC PD-L1 High 2L+ Cohort|Participants with UC (post-platinum PD-L1 status high) who had received at least 1 line of prior therapy (2L+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119092|NCT01693562|OG004|Outcome|Escalation Cohort (MEDI4736 10 mg/kg Q2W)|Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119093|NCT01693562|OG006|Outcome|Exploration Cohort (MEDI4736 20 mg/kg Q4W)|Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119094|NCT01693562|OG000|Outcome|Total Escalation/Exploration Cohort|Participants received IV infusion of MEDI4736 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg Q2W, and 15 mg/kg Q3W in the dose-escalation phase; and 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119095|NCT01693562|OG001|Outcome|Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119096|NCT01693562|OG002|Outcome|Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119097|NCT01693562|OG003|Outcome|Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119098|NCT01693562|OG004|Outcome|Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)|Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119099|NCT01693562|OG005|Outcome|Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119100|NCT01693562|OG006|Outcome|Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119101|NCT01693562|OG007|Outcome|Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11348377|NCT04179474|EG004|Reported Event|Part 2: Intervention C (Galcanezumab)|Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
11119102|NCT01693562|OG008|Outcome|Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119103|NCT01693562|OG009|Outcome|Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119104|NCT01693562|OG010|Outcome|Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119105|NCT01693562|OG011|Outcome|Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119106|NCT01693562|OG012|Outcome|Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119107|NCT01693562|OG013|Outcome|Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)|Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119108|NCT01693562|OG014|Outcome|Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119109|NCT01693562|OG015|Outcome|Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)|Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119110|NCT01693562|OG016|Outcome|Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119111|NCT01693562|OG000|Outcome|Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)|Participants with SCCHN received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119112|NCT01693562|OG001|Outcome|Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with NSCLC received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119113|NCT01693562|OG000|Outcome|Total Escalation/Exploration Cohort|Participants received IV infusion of MEDI4736 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg Q2W, and 15 mg/kg Q3W in the dose-escalation phase; and 20 mg/kg Q4W in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119114|NCT01693562|OG000|Outcome|Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)|Participants with squamous SCCHN received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119115|NCT01693562|OG000|Outcome|Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119116|NCT01693562|OG001|Outcome|Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119117|NCT01693562|OG002|Outcome|Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11348378|NCT04179474|EG005|Reported Event|Part 2: Intervention D (Ubrogepant)|Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
11119118|NCT01693562|OG003|Outcome|Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)|Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119119|NCT01693562|OG004|Outcome|Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119120|NCT01693562|OG005|Outcome|Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119121|NCT01693562|OG006|Outcome|Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119122|NCT01693562|OG007|Outcome|Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119123|NCT01693562|OG008|Outcome|Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119124|NCT01693562|OG009|Outcome|Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119125|NCT01693562|OG010|Outcome|Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119126|NCT01693562|OG011|Outcome|Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119127|NCT01693562|OG012|Outcome|Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)|Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119128|NCT01693562|OG013|Outcome|Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119129|NCT01693562|OG014|Outcome|Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)|Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119130|NCT01693562|OG015|Outcome|Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119131|NCT01693562|OG000|Outcome|Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with NSCLC received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119132|NCT01693562|OG000|Outcome|Expansion UC PD-L1 Low/Negative Cohort|Participants with UC (PD-L1 status low/Negative) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119133|NCT01693562|OG001|Outcome|Expansion UC Total Cohort|Participants with UC (Total PD-L1 status - high, low/Negative, and unknown) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119134|NCT01693562|OG002|Outcome|Expansion UC PD-L1 High Cohort|Participants with UC (PD-L1 status high) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11005843|NCT01083160|OG000|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
11005844|NCT01083160|EG000|Reported Event|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
11005845|NCT01083173|BG000|Baseline|Overall Study|The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks.
11005846|NCT01083173|FG000|Participant Flow|Main Surveillance|The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks.
11005847|NCT01083173|FG001|Participant Flow|Long-term Surveillance|The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.
11005848|NCT01083173|OG000|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
11005849|NCT01083173|OG001|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
11005850|NCT01083173|OG000|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
11005851|NCT01083173|OG001|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
11005852|NCT01083173|OG000|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
11005853|NCT01083173|EG000|Reported Event|Main Surveillance|All participants who received at least one dose of Kaletra
11005854|NCT01083173|EG001|Reported Event|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
11005855|NCT01083186|BG000|Baseline|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
11005856|NCT01083186|FG000|Participant Flow|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
11005857|NCT01083186|OG000|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
11005858|NCT01083186|OG000|Outcome|Participants Within the iPTH Target Range|Number of participants with iPTH levels within the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
11005859|NCT01083186|OG001|Outcome|Participants Out of the iPTH Target Range|Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
11005860|NCT01083186|OG000|Outcome|Participants Within the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
11005861|NCT01083186|OG001|Outcome|Participants Outside of the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
11005862|NCT01083186|OG000|Outcome|Participants Within the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
11005863|NCT01083186|OG001|Outcome|Participants Outside of the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
11005864|NCT01083186|OG000|Outcome|No Albuminuria at Month 6|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
11005865|NCT01083186|OG001|Outcome|Trace Albuminuria at Month 6|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
11005866|NCT01083186|OG002|Outcome|"+ Albuminuria at Month 6"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
11005867|NCT01083186|OG003|Outcome|"++ Albuminuria at Month 6"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
11005868|NCT01083186|OG004|Outcome|"+++ Albuminuria at Month 6"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
11005869|NCT01083186|OG000|Outcome|No Albuminuria at Month 12|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
11005870|NCT01083186|OG001|Outcome|Trace Albuminuria at Month 12|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
11005871|NCT01083186|OG002|Outcome|"+ Albuminuria at Month 12"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
11005872|NCT01083186|OG003|Outcome|"++ Albuminuria at Month 12"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
11005873|NCT01083186|OG004|Outcome|"+++ Albuminuria at Month 12"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
11005874|NCT01083186|OG000|Outcome|CKD Stage 2|Participants with chronic kidney disease stage 2 (eGFR 60-89 mL/min/1.73m^2) with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
11005875|NCT01083186|OG001|Outcome|CKD Stage 3|Participants with chronic kidney disease stage 3 (eGFR 30-59 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
11005876|NCT01083186|OG002|Outcome|CKD Stage 4|Participants with chronic kidney disease stage 4 (eGFR 15-29 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
11005877|NCT01083186|OG003|Outcome|CKD Stage 5|Participants with chronic kidney disease stage 5 (eGFR <15 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
11005878|NCT01083186|EG000|Reported Event|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
11005879|NCT01083199|BG000|Baseline|AMS CONTINUUM™ Device|
11005880|NCT01083199|FG000|Participant Flow|AMS CONTINUUM™ Device|
11005881|NCT01083199|OG000|Outcome|Continuum Device|
11005882|NCT01083199|OG000|Outcome|AMS CONTINUUM™ Device|
11005883|NCT01083199|EG000|Reported Event|AMS CONTINUUM™ Device|
11005884|NCT01083316|BG000|Baseline|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose intravenous (IV) Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
11005885|NCT01083316|FG000|Participant Flow|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
11005886|NCT01083316|OG000|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
11005887|NCT01083316|OG000|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Dexamethasone: Induction:~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Melphalan: Conditioning:~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
11005888|NCT01083316|EG000|Reported Event|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
11005889|NCT01083368|BG000|Baseline|Dose Level 1|Temsirolimus 20 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
11005890|NCT01083368|BG001|Baseline|Dose Level 2|Temsirolimus 25 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
11005891|NCT01083368|BG002|Baseline|Total|Total of all reporting groups
11005892|NCT01083368|FG000|Participant Flow|Dose Level -1|"Temsirolimus 15 mg IV q wk with Bevacizumab 5 mg/kg IV q 2 wks~This is a de-escalation dose levels and no participants ended up receiving this dose level."
11005893|NCT01083368|FG001|Participant Flow|Dose Level 0|"Temsirolimus 15 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks~This is a de-escalation dose levels, and no participants ended up receiving this dose level."
11005894|NCT01083368|FG002|Participant Flow|Dose Level 1|Temsirolimus 20 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
11005895|NCT01083368|FG003|Participant Flow|Dose Level 2|Temsirolimus 25 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
11119135|NCT01693562|OG000|Outcome|Expansion UC PD-L1 High Cohort|Participants with UC (PD-L1 status high) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11005896|NCT01083368|OG000|Outcome|Dose Levels 1 and 2|"Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~bevacizumab: Given IV~polymorphism analysis: Correlative studies~laboratory biomarker analysis: Correlative studies"
11005897|NCT01083368|OG000|Outcome|Dose Level 2|Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
11005898|NCT01083368|OG000|Outcome|Combination of Temsirolimus and AVASTIN|"Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~bevacizumab: Given IV~polymorphism analysis: Correlative studies~laboratory biomarker analysis: Correlative studies"
11005899|NCT01083368|OG000|Outcome|Arm 1: Combination of Temsirolimus and AVASTIN|"Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~bevacizumab: Given IV~polymorphism analysis: Correlative studies~laboratory biomarker analysis: Correlative studies"
11005900|NCT01083368|EG000|Reported Event|Dose Level 1|"Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~bevacizumab: Given IV~polymorphism analysis: Correlative studies~laboratory biomarker analysis: Correlative studies"
11005901|NCT01083368|EG001|Reported Event|Dose Level 2|"Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~bevacizumab: Given IV~polymorphism analysis: Correlative studies"
11005902|NCT01083485|BG000|Baseline|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
11005903|NCT01083485|BG001|Baseline|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
11005904|NCT01083485|BG002|Baseline|Total|Total of all reporting groups
11005905|NCT01083485|FG000|Participant Flow|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
11005906|NCT01083485|FG001|Participant Flow|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
11005907|NCT01083485|OG000|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.4
11005908|NCT01083485|OG001|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.1
11005909|NCT01083485|OG000|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
11005910|NCT01083485|OG001|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
11005911|NCT01083485|EG000|Reported Event|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
11005912|NCT01083485|EG001|Reported Event|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
11005913|NCT01083576|BG000|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
11005914|NCT01083576|BG001|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
11005915|NCT01083576|BG002|Baseline|Total|Total of all reporting groups
11005916|NCT01083576|FG000|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
11005917|NCT01083576|FG001|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
11005918|NCT01083576|OG000|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
11005919|NCT01083576|OG001|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
11005920|NCT01083576|OG000|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
11005921|NCT01083576|EG000|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
11005922|NCT01083576|EG001|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
11005923|NCT01083602|BG000|Baseline|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
11005924|NCT01083602|FG000|Participant Flow|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
11005925|NCT01083602|OG000|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
11005926|NCT01083602|EG000|Reported Event|PAN + BTZ + Dex|PAN + BTZ + Dex
11005927|NCT01083628|BG000|Baseline|Group CBT With Text Messaging Adjunct|Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
11005928|NCT01083628|BG001|Baseline|Group CBT for Depression|Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
11005929|NCT01083628|BG002|Baseline|Total|Total of all reporting groups
11005930|NCT01083628|FG000|Participant Flow|Group CBT With Text Messaging Adjunct|Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
11005931|NCT01083628|FG001|Participant Flow|Group CBT for Depression|Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
11005932|NCT01083628|OG000|Outcome|Group CBT With Text Messaging Adjunct|Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
11005933|NCT01083628|OG001|Outcome|Group CBT for Depression|Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
11005934|NCT01083628|EG000|Reported Event|Group CBT With Text Messaging Adjunct|Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
11005935|NCT01083628|EG001|Reported Event|Group CBT for Depression|Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
11005936|NCT01083641|BG000|Baseline|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
11119136|NCT01693562|OG001|Outcome|Expansion UC PD-L1 Low/Negative Cohort|Participants with UC (PD-L1 status low/Negative) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119137|NCT01693562|EG000|Reported Event|Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)|Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119138|NCT01693562|EG001|Reported Event|Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)|Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119139|NCT01693562|EG002|Reported Event|Escalation Cohort (MEDI4736 1 mg/kg Q2W)|Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119140|NCT01693562|EG003|Reported Event|Escalation Cohort (MEDI4736 3 mg/kg Q2W)|Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119141|NCT01693562|EG004|Reported Event|Escalation Cohort (MEDI4736 10 mg/kg Q2W)|Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119142|NCT01693562|EG005|Reported Event|Escalation Cohort (MEDI4736 15 mg/kg Q3W)|Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119143|NCT01693562|EG006|Reported Event|Exploration Durvalumab 20 mg/kg (Q4W)|Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119144|NCT01693562|EG007|Reported Event|Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119145|NCT01693562|EG008|Reported Event|Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119146|NCT01693562|EG009|Reported Event|Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119147|NCT01693562|EG010|Reported Event|Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)|Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119148|NCT01693562|EG011|Reported Event|Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
10848771|NCT00291447|OG000|Outcome|Cohort 1|"Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11119149|NCT01693562|EG012|Reported Event|Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119150|NCT01693562|EG013|Reported Event|Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119151|NCT01693562|EG014|Reported Event|Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11005937|NCT01083641|FG000|Participant Flow|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
11005938|NCT01083641|OG000|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
11005939|NCT01083641|EG000|Reported Event|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
11005940|NCT01083654|BG000|Baseline|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~ST Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by an enrolled member of the Menominee Tribe but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling."
11005941|NCT01083654|BG001|Baseline|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)"
11005942|NCT01083654|BG002|Baseline|Total|Total of all reporting groups
11005943|NCT01083654|FG000|Participant Flow|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
11005944|NCT01083654|FG001|Participant Flow|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
11005945|NCT01083654|OG000|Outcome|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
11005946|NCT01083654|OG001|Outcome|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
11007961|NCT01093885|FG000|Participant Flow|Open Label: Medication Ambrisentan|"Open label study of Ambrisentan.~Ambrisentan will begin at 5mg daily for the first month.~Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week. Subjects will continue their present dose and schedule of disease modifying/antifibrotic medication for the duration of the study.~Ambrisentan: Drug is dispensed in tablet form. Ambrisentan with anti-fibrotic to assess benefit on skin~Dosing of ambrisentan will begin at 5mg daily for the first month. Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week."
11119152|NCT01693562|EG015|Reported Event|Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119153|NCT01693562|EG016|Reported Event|Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119154|NCT01693562|EG017|Reported Event|Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)|Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119155|NCT01693562|EG018|Reported Event|Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119156|NCT01693562|EG019|Reported Event|Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)|Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119157|NCT01693562|EG020|Reported Event|Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119158|NCT01693562|EG021|Reported Event|Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)|Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119159|NCT01693562|EG022|Reported Event|Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)|Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
11119160|NCT01693614|BG000|Baseline|DLBCL Cohort|Diffuse large B-cell lymphoma cohort
11119161|NCT01693614|BG001|Baseline|MCL Cohort|Mantle cell lymphoma cohort
11119162|NCT01693614|BG002|Baseline|FL Cohort|Follicular lymphoma cohort
11119163|NCT01693614|BG003|Baseline|Total|Total of all reporting groups
11119164|NCT01693614|FG000|Participant Flow|DLBCL Cohort|Diffuse large B-cell lymphoma cohort
11119165|NCT01693614|FG001|Participant Flow|MCL Cohort|Mantle cell lymphoma cohort
11119166|NCT01693614|FG002|Participant Flow|FL Cohort|Follicular lymphoma cohort
11119167|NCT01693614|OG000|Outcome|DLBCL Cohort|Diffuse large B-cell lymphoma cohort
11119168|NCT01693614|OG001|Outcome|MCL Cohort|Mantle cell lymphoma cohort
11119169|NCT01693614|OG002|Outcome|FL Cohort|Follicular lymphoma cohort
11119170|NCT01693614|OG001|Outcome|FL Cohort|Follicular lymphoma cohort
11119171|NCT01693614|EG000|Reported Event|DLBCL Cohort|DLBCL
11119172|NCT01693614|EG001|Reported Event|MCL Cohort|MCL
11119173|NCT01693614|EG002|Reported Event|FL Cohort|FL
11119174|NCT01693900|BG000|Baseline|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
11119175|NCT01693900|BG001|Baseline|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
11119176|NCT01693900|BG002|Baseline|Total|Total of all reporting groups
11119177|NCT01693900|FG000|Participant Flow|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
11119178|NCT01693900|FG001|Participant Flow|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
11119179|NCT01693900|OG000|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
11119180|NCT01693900|OG001|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
11119181|NCT01693900|EG000|Reported Event|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
11119182|NCT01693900|EG001|Reported Event|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
11119183|NCT01694108|BG000|Baseline|BCG-vaccine|SSI strain 1331 standard dose
11119184|NCT01694108|BG001|Baseline|Control Children|No intervention
11119185|NCT01694108|BG002|Baseline|Total|Total of all reporting groups
11119186|NCT01694108|FG000|Participant Flow|BCG-vaccine|
11119187|NCT01694108|FG001|Participant Flow|Control Children (no Intervention)|
11119188|NCT01694108|OG000|Outcome|BCG-vaccine|
11119189|NCT01694108|OG001|Outcome|Control Children (no Intervention)|
11119190|NCT01694108|OG000|Outcome|BCG-vaccine|SSI strain 1331 standard dose
11119191|NCT01694108|OG001|Outcome|Control Children|No intervention
11119192|NCT01694108|OG000|Outcome|BCG-vaccine|SS! strain 1331 standard dose
11119193|NCT01694108|OG000|Outcome|Participating Mothers|Mothers who decided to let their child participate in the study
11119194|NCT01694108|OG001|Outcome|Declining Mothers|Mothers who decided not to let their child participate in the study
11119195|NCT01694108|OG000|Outcome|Telephone|Randomized to receive information about the study by telephone
11119196|NCT01694108|OG001|Outcome|Face-to-face|Randomized to receive information about the study by standard face-to-face consultation.
11119197|NCT01694108|EG000|Reported Event|BCG-vaccine|
11119198|NCT01694108|EG001|Reported Event|Control Children (no Intervention)|
11119199|NCT01694121|BG000|Baseline|MEN Count|"3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.~MEN Count: The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period."
11119200|NCT01694121|BG001|Baseline|Comparison|"An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.~Comparison: general health intervention for men, not inclusive of HIV or relationship health"
11119201|NCT01694121|BG002|Baseline|Total|Total of all reporting groups
11119202|NCT01694121|FG000|Participant Flow|MEN Count|"3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.~MEN Count: The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period."
11119203|NCT01694121|FG001|Participant Flow|Comparison|"An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.~Comparison: general health intervention for men, not inclusive of HIV or relationship health"
11119204|NCT01694121|OG000|Outcome|MEN Count|"3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.~MEN Count: The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period."
11119205|NCT01694121|OG001|Outcome|Comparison|"An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.~Comparison: general health intervention for men, not inclusive of HIV or relationship health"
11119206|NCT01694121|EG000|Reported Event|MEN Count|"3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.~MEN Count: The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period."
11119207|NCT01694121|EG001|Reported Event|Comparison|"An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.~Comparison: general health intervention for men, not inclusive of HIV or relationship health"
11119208|NCT01694186|BG000|Baseline|Sham Injection|"Sham injection~Sham injection"
11119209|NCT01694186|BG001|Baseline|FAI Insert|"FAI insert (0.18 mg fluocinolone acetonide)~FAI insert"
11119210|NCT01694186|BG002|Baseline|Total|Total of all reporting groups
11119211|NCT01694186|FG000|Participant Flow|Sham Injection|"sham injection~Sham injection"
11119212|NCT01694186|FG001|Participant Flow|FAI Insert|"FAI insert (0.18 mg fluocinolone acetonide)~FAI insert"
11119213|NCT01694186|OG000|Outcome|Sham Injection|"sham injection~Sham injection The sham applicator was an empty 1-mL syringe attached to a blunt 14-gauge needle; it did not contain an FAI insert. During study Day 1, the sham applicator was gently pressed against the study eye to provide the subject with the perception that an intravitreal injection was being performed. This procedure was performed to mask study subjects to their assigned treatment."
11119214|NCT01694186|OG001|Outcome|FAI Insert|"FAI insert (0.18 mg fluocinolone acetonide) One treatment (FAI injection) was administered on Day 1 to each subject. The Fluocinolone Acetonide Intravitreal Insert (FAI insert) is an injectable intravitreal sustained-release FA delivery system preloaded into an injection device. Each insert contained a drug core of FA as the active ingredient within a cylindrical polyimide polymer tube 3.5-mm long with an external diameter of 0.37 mm.~The dose delivered in the FAI insert was 0.18 mg fluocinolone acetonide delivered into the vitreous humor for 36 months. The FAI insert was administered to the study eye by injection through the pars plana using a preloaded applicator with a 25-gauge needle."
11119215|NCT01694186|EG000|Reported Event|Sham Injection|"sham injection~Sham injection"
11119216|NCT01694186|EG001|Reported Event|FAI Insert|"FAI insert (0.18 mg fluocinolone acetonide)~FAI insert"
11119217|NCT01694199|BG000|Baseline|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
11119218|NCT01694199|BG001|Baseline|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
11119219|NCT01694199|BG002|Baseline|Total|Total of all reporting groups
11119220|NCT01694199|FG000|Participant Flow|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
11119221|NCT01694199|FG001|Participant Flow|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
11119222|NCT01694199|OG000|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
11119223|NCT01694199|OG001|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
11348379|NCT04178590|BG000|Baseline|All Study Participants|Study participants randomly assigned to receive two different treatments in cross- over study design : scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin and Scaling and root planing in conjunction with saline
11119224|NCT01694199|EG000|Reported Event|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
11119225|NCT01694199|EG001|Reported Event|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
11126819|NCT01735981|BG001|Baseline|Hand Held Video Game (Control), Then Dance Dance Revolution Exercise|Individuals first participated in the control group: a hand-held video game. Then completed the video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance.
11126820|NCT01735981|BG002|Baseline|Total|Total of all reporting groups
11126821|NCT01735981|FG000|Participant Flow|Dance Dance Revolution Exercise, Then Hand Held Video Game (Control)|Participants first completed the video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance. Then participated in a hand held video game as the control activity.
11126822|NCT01735981|FG001|Participant Flow|Hand Held Video Game (Control), Then Dance Dance Revolution Exercise|Individuals first participated in the control group: a hand-held video game. Then completed the video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance.
11126823|NCT01735981|OG000|Outcome|Dance Dance Revolution Exercise|All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.
11126824|NCT01735981|OG001|Outcome|Hand Held Video Game (Control)|All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
11126825|NCT01735981|OG000|Outcome|Video Game Exercise|"Video game exercise using Dance Dance Revolution~Video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance"
11126826|NCT01735981|OG001|Outcome|Control|"hand-held video game control~hand-held video game: hand-held video games"
11126827|NCT01735981|EG000|Reported Event|Dance Dance Revolution Exercise|All participants who were initially enrolled into the group with the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.
11126828|NCT01735981|EG001|Reported Event|Hand Held Video Game (Control)|All participants that who were initially enrolled into the control group with the hand-held video game control for the first 6 weeks or the second 6 weeks of the study.
11126829|NCT01735994|BG000|Baseline|Healthy Weight Intervention|"Eating Disorder Prevention Program~Healthy Weight: Eating Disorder Prevention Program for Athletes"
11126830|NCT01735994|BG001|Baseline|Brochure Wait List|"Brochure wait list control group~Brochure: Brochure on the Female athlete triad"
11126831|NCT01735994|BG002|Baseline|Total|Total of all reporting groups
11126832|NCT01735994|FG000|Participant Flow|Healthy Weight Intervention|"Eating Disorder Prevention Program~Healthy Weight: Eating Disorder Prevention Program for Athletes"
11126833|NCT01735994|FG001|Participant Flow|Brochure Wait List|"Brochure wait list control group~Brochure: Brochure on the Female athlete triad"
11119226|NCT01694420|BG000|Baseline|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
11119227|NCT01694420|FG000|Participant Flow|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
11119228|NCT01694420|OG000|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
11119229|NCT01694420|EG000|Reported Event|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
11119230|NCT01694433|BG000|Baseline|Calcipotriene Cream|"The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.~Calcipotriene: 1g daily BID"
11119231|NCT01694433|BG001|Baseline|Placebo|"The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.~Placebo: 1g daily BID"
11119232|NCT01694433|BG002|Baseline|Total|Total of all reporting groups
11119233|NCT01694433|FG000|Participant Flow|Calcipotriene Cream|"The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.~Calcipotriene: 1g daily BID"
11119234|NCT01694433|FG001|Participant Flow|Placebo|"The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.~Placebo: 1g daily BID"
11119235|NCT01694433|OG000|Outcome|Calcipotriene Cream|"The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.~Calcipotriene: 1g daily BID"
11119236|NCT01694433|OG001|Outcome|Placebo|"The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.~Placebo: 1g daily BID"
11119237|NCT01694433|EG000|Reported Event|Calcipotriene Cream|"The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.~Calcipotriene: 1g daily BID"
11119238|NCT01694433|EG001|Reported Event|Placebo|"The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.~Placebo: 1g daily BID"
11119239|NCT01694485|BG000|Baseline|Placebo|Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119240|NCT01694485|BG001|Baseline|Abrilumab 7 mg Q4W|Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119241|NCT01694485|BG002|Baseline|Abrilumab 21 mg Q4W|Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119242|NCT01694485|BG003|Baseline|Abrilumab 70 mg Q4W|Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119243|NCT01694485|BG004|Baseline|Abrilumab 210 mg|Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119244|NCT01694485|BG005|Baseline|Total|Total of all reporting groups
11119245|NCT01694485|FG000|Participant Flow|Placebo/Abrilumab 210 mg Q3M|"Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks."
11119246|NCT01694485|FG001|Participant Flow|Abrilumab 7 mg Q4W/Abrilumab 210 mg Q3M|"Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks."
11119247|NCT01694485|FG002|Participant Flow|Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M|"Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks."
11119248|NCT01694485|FG003|Participant Flow|Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M|"Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks."
11119249|NCT01694485|FG004|Participant Flow|Abrilumab 210 mg/Abrilumab 210 mg Q3M|"Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks."
11119250|NCT01694485|OG000|Outcome|Placebo|Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119251|NCT01694485|OG001|Outcome|Abrilumab 7 mg Q4W|Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119252|NCT01694485|OG002|Outcome|Abrilumab 21 mg Q4W|Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119253|NCT01694485|OG003|Outcome|Abrilumab 70 mg Q4W|Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119254|NCT01694485|OG004|Outcome|Abrilumab 210 mg|Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119255|NCT01694485|EG000|Reported Event|DB Period: Placebo|Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind (DB) treatment period.
11119256|NCT01694485|EG001|Reported Event|DB Period: Abrilumab 7 mg Q4W|Participants received 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
11119257|NCT01694485|EG002|Reported Event|DB Period: Abrilumab 21 mg Q4W|Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119258|NCT01694485|EG003|Reported Event|DB Period: Abrilumab 70 mg Q4W|Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119259|NCT01694485|EG004|Reported Event|DB Period: Abrilumab 210 mg|Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119260|NCT01694485|EG005|Reported Event|OL Period: Placebo/Abrilumab 210 mg Q3M|Participants who received placebo during the double-blind treatment period received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks during the open-label (OL) treatment period.
11119261|NCT01694485|EG006|Reported Event|OL Period: Abrilumab 7 mg Q4W/210 mg Q3M|Participants who received 7 mg abrilumab Q4W in the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
11119262|NCT01694485|EG007|Reported Event|OL Period: Abrilumab 21 mg Q4W/210 mg Q3M|During the open-label period, participants who received 21 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks.
11119263|NCT01694485|EG008|Reported Event|OL Period: Abrilumab 70 mg Q4W/210 mg Q3M|Participants who received 70 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
11119264|NCT01694485|EG009|Reported Event|OL Period: Abrilumab 210 mg/210 mg Q3M|Participants who received 210 mg abrilumab during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
11119265|NCT01694563|BG000|Baseline|Atrial Fibrillation|"Patients with non-paroxysmal atrial fibrillation (persistent or longstanding persistent)who are scheduled to undergo elective concomitant open, on-pump cardiac surgical procedure and the Maze IV ablation procedure. This single arm registry is designed to monitor the AtriCure Synergy Ablation System for continued safety and efficacy during the peri-procedural and long term phase during commercial use.~Synergy Ablation System: Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following:~Coronary Artery Bypass Grafting (CABG)~Mitral valve repair or replacement~Aortic valve repair or replacement~Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria."
11119266|NCT01694563|FG000|Participant Flow|Atrial Fibrillation|Subjects enrolled exhibited the following types of Atrial fibrillation: Non-Paroxysmal, Persistent, and Long-Standing Persistent
11119267|NCT01694563|OG000|Outcome|36 Months Post-operatively|The primary effectiveness outcome is defined as the proportion of patients free from AF (i.e. no episodes lasting > 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) while off Class I and III antiarrhythmic drugs for at least 4 weeks as determined by an independent core lab assessment of 48 hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 36 months postoperatively.
11119268|NCT01694563|OG000|Outcome|12 Months Post-operatively|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.
11119269|NCT01694563|OG001|Outcome|24 Months Post-operatively|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.
11119270|NCT01694563|OG002|Outcome|36 Months Post-operatively|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.
11119271|NCT01694563|EG000|Reported Event|Treatment Arm|Patients with non-paroxysmal atrial fibrillation ………..
11119272|NCT01694641|BG000|Baseline|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
11119273|NCT01694641|BG001|Baseline|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
11119274|NCT01694641|BG002|Baseline|Total|Total of all reporting groups
11119275|NCT01694641|FG000|Participant Flow|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
11119276|NCT01694641|FG001|Participant Flow|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
11119277|NCT01694641|OG000|Outcome|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
11119278|NCT01694641|OG001|Outcome|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
11119279|NCT01694641|OG000|Outcome|Time-lapse Morphokinetic Evaluation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos in a petri dish that allows individual assessment (Primo Vision Dish) are placed onto an automated time-lapse equipment in an incubator. The time-lapse equipment performs imaging in 10 minutes intervals. The software is presenting the up-to-date images and allows the operator to assess the time-lapse movie of the developmental history of the embryos to perform annotations and apply evaluation/selection algorithm. This morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection, which actually describes the intervention.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
11119280|NCT01694641|EG000|Reported Event|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
11119281|NCT01694641|EG001|Reported Event|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
11119282|NCT01694667|BG000|Baseline|Omega-3|Participants randomized to omega-3
11119283|NCT01694667|BG001|Baseline|Placebo|Participants randomized to placebo
11119284|NCT01694667|BG002|Baseline|Total|Total of all reporting groups
11119285|NCT01694667|FG000|Participant Flow|Omega-3 Fatty Acids|"Omega-3 fatty acids will be delivered in orange-flavored pudding packets and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~29 participants allocated to this group."
11119286|NCT01694667|FG001|Participant Flow|Placebo|"Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil.~Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~28 participants allocated to this group."
11119287|NCT01694667|OG000|Outcome|Omega-3|Participants randomized to omega-3
11119288|NCT01694667|OG001|Outcome|Placebo|Participants randomized to placebo
11119289|NCT01694667|EG000|Reported Event|Omega-3|Participants randomized to omega-3
11119290|NCT01694667|EG001|Reported Event|Placebo|Participants randomized to placebo
11119291|NCT01694706|BG000|Baseline|Entire Study Population|"All subjects received all tested treatments in a randomised, open label, 3-way cross over study. The treatments were:~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Drug administrations were separated by a washout period of at least 14 days"
11119292|NCT01694706|FG000|Participant Flow|Faldaprevir/Faldaprevir+ OMP/Faldaprevir Fed|"Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration.~Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less."
11119293|NCT01694706|FG001|Participant Flow|Faldaprevir Fed/ Faldaprevir/ Faldaprevir+ OMP|"Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)~faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir."
11126834|NCT01735994|OG000|Outcome|Healthy Weight Intervention|"Eating Disorder Prevention Program~Healthy Weight: Eating Disorder Prevention Program for Athletes"
11126835|NCT01735994|OG001|Outcome|Brochure Wait List|"Brochure wait list control group~Brochure: Brochure on the Female athlete triad"
11126836|NCT01735994|EG000|Reported Event|Healthy Weight Intervention|"Eating Disorder Prevention Program~Healthy Weight: Eating Disorder Prevention Program for Athletes"
11126837|NCT01735994|EG001|Reported Event|Brochure Wait List|"Brochure wait list control group~Brochure: Brochure on the Female athlete triad"
11119294|NCT01694706|FG002|Participant Flow|Faldaprevir+ OMP/ Faldaprevir Fed/ Faldaprevir|"Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration"
11119295|NCT01694706|OG000|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
11119296|NCT01694706|OG001|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
11119297|NCT01694706|OG002|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
11119298|NCT01694706|EG000|Reported Event|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
11119299|NCT01694706|EG001|Reported Event|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
11119300|NCT01694706|EG002|Reported Event|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast
11119301|NCT01694706|EG003|Reported Event|Omeprazole|40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
11119302|NCT01694771|BG000|Baseline|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
11119303|NCT01694771|BG001|Baseline|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
11119304|NCT01694771|BG002|Baseline|Total|Total of all reporting groups
11119305|NCT01694771|FG000|Participant Flow|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
11119306|NCT01694771|FG001|Participant Flow|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
11119307|NCT01694771|OG000|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
11119308|NCT01694771|OG001|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
11119309|NCT01694771|EG000|Reported Event|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
11119310|NCT01694771|EG001|Reported Event|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
11119311|NCT01694966|BG000|Baseline|Methylene Blue MMX® 200mg|"Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule~Methylene Blue MMX®"
11119312|NCT01694966|BG001|Baseline|Methylene Blue MMX® 100mg|"Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule~Methylene Blue MMX®~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
11119313|NCT01694966|BG002|Baseline|Placebo|"Oral dose, 8 Placebo tablets over a 4hr schedule~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
11119314|NCT01694966|BG003|Baseline|Total|Total of all reporting groups
11119315|NCT01694966|FG000|Participant Flow|Methylene Blue MMX® 200mg|"Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule~Methylene Blue MMX®"
11119316|NCT01694966|FG001|Participant Flow|Methylene Blue MMX® 100mg|"Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule~Methylene Blue MMX®~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
11119317|NCT01694966|FG002|Participant Flow|Placebo|"Oral dose, 8 Placebo tablets over a 4hr schedule~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
11119318|NCT01694966|OG000|Outcome|Methylene Blue MMX® 200mg|"Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule~Methylene Blue MMX®"
11119319|NCT01694966|OG001|Outcome|Methylene Blue MMX® 100mg|"Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule~Methylene Blue MMX®~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
11119320|NCT01694966|OG002|Outcome|Placebo|"Oral dose, 8 Placebo tablets over a 4hr schedule~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
11119321|NCT01694966|EG000|Reported Event|Methylene Blue MMX® 200mg|"Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule~Methylene Blue MMX®"
11119322|NCT01694966|EG001|Reported Event|Methylene Blue MMX® 100mg|"Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule~Methylene Blue MMX®~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
11119323|NCT01694966|EG002|Reported Event|Placebo|"Oral dose, 8 Placebo tablets over a 4hr schedule~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
11119324|NCT01695044|BG000|Baseline|Arm 1: PSMA ADC Chemotherapy-experienced|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
11119325|NCT01695044|BG001|Baseline|Arm 2: PSMA ADC Chemotherapy-naive|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
11119326|NCT01695044|BG002|Baseline|Total|Total of all reporting groups
11119327|NCT01695044|FG000|Participant Flow|Arm 1: PSMA ADC|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
11119328|NCT01695044|OG000|Outcome|PSMA ADC Chemotherapy-experienced|"Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
11119329|NCT01695044|OG001|Outcome|Chemotherapy-naive|"Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
11119330|NCT01695044|OG000|Outcome|PSMA ADC Chemotherapy-experienced|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
11119331|NCT01695044|OG001|Outcome|Chemotherapy-naive|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
11119332|NCT01695044|EG000|Reported Event|PSMA ADC Chemotherapy-experienced|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
11119333|NCT01695044|EG001|Reported Event|Chemotherapy-naive|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
11119334|NCT01695135|BG000|Baseline|Placebo + Prednisone (Double-blind)|Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
11119335|NCT01695135|BG001|Baseline|Abiraterone Acetate + Prednisone (Double-blind)|Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
11119336|NCT01695135|BG002|Baseline|Total|Total of all reporting groups
10848772|NCT00291447|OG001|Outcome|Cohort 2|"Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11119337|NCT01695135|FG000|Participant Flow|Placebo + Prednisone (Double-blind [DB])|Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
11119338|NCT01695135|FG001|Participant Flow|Abiraterone Acetate + Prednisone (Double-blind)|Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
11119339|NCT01695135|FG002|Participant Flow|Placebo + Prednisone (DB) to AA + Prednisone (Open-label)|Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
11119340|NCT01695135|FG003|Participant Flow|AA + Prednisone to AA + Prednisone (Open-label)|Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
11119341|NCT01695135|OG000|Outcome|Placebo + Prednisone (Double-blind)|Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
11119342|NCT01695135|OG001|Outcome|Abiraterone Acetate + Prednisone (Double-blind)|Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
11119343|NCT01695135|EG000|Reported Event|Placebo + Prednisone (Double-blind)|Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
11126838|NCT01736085|BG000|Baseline|Material Group|Subjects will receive self-help materials
11119344|NCT01695135|EG001|Reported Event|Abiraterone Acetate + Prednisone (Double-blind)|Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
11119345|NCT01695135|EG002|Reported Event|Placebo + Prednisone (DB) to AA + Prednisone (Open-label)|Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
11119346|NCT01695135|EG003|Reported Event|AA + Prednisone to AA + Prednisone (Open-label)|Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
11119347|NCT01695239|BG000|Baseline|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
11119348|NCT01695239|BG001|Baseline|ADA Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
11119349|NCT01695239|BG002|Baseline|Ixe Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119350|NCT01695239|BG003|Baseline|Ixe Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119351|NCT01695239|BG004|Baseline|Total|Total of all reporting groups
11119352|NCT01695239|FG000|Participant Flow|Placebo (PBO)|Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.
11119353|NCT01695239|FG001|Participant Flow|Adalimumab (ADA) Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
11119354|NCT01695239|FG002|Participant Flow|Ixe Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119355|NCT01695239|FG003|Participant Flow|Ixe Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119356|NCT01695239|FG004|Participant Flow|Inadequate Responders (IR)/Ixe Q4W|Placebo Week 16 inadequate responders (IRs) re-randomized to ixekizumab 80 mg every 4 weeks (Q4W) received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab Q4W IRs received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.
11119357|NCT01695239|FG005|Participant Flow|IR/Ixe Q2W|Placebo IRs re-randomized to ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab 80 mg Q2W IRs received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.
11119358|NCT01695239|FG006|Participant Flow|IR PBO Washout|Adalimumab Q2W IRs re-randomized to ixekizumab 80 mg Q4W or ixekizumab 80 mg Q2W. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 16. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 18 to Week 22. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24.
11119359|NCT01695239|FG007|Participant Flow|PBO Washout|Adalimumab Q2W participants re-randomized to ixekizumab 80 mg Q4W or ixekizumab Q2W Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 24. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 26 to Week 30. Participants received a dose of 80 mg of ixekizumab given as 1 SC injection at Week 32.
11119360|NCT01695239|FG008|Participant Flow|Ixe Q4W/Ixe Q4W|Participants continuing on 1 injection of ixekizumab 80 mg Q4W starting on Week 24 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 28 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 32 and ending on Week 156 alternating with placebo injections Q4W starting on Week 34 and ending on Week 154.
11119361|NCT01695239|FG009|Participant Flow|Ixe Q2W/Ixe Q2W|Participants continuing on 1 injection of ixekizumab 80 mg Q2W starting on Week 24 and ending on Week 156. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg Q2W at Week 16 and Week 24. Placebo washout participants who re-randomized at Week 16 receive a starting dose of 160 mg ixekizumab given as 2 SC injections of 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 28 and ending on Week 156. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 32 and ending on Week 156.
11119362|NCT01695239|FG010|Participant Flow|Placebo Post-Treatment Follow-up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.
11119363|NCT01695239|FG011|Participant Flow|Adalimumab Post-Treatment Follow-up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.
11119364|NCT01695239|FG012|Participant Flow|Ixekizumab 80mg Q4W Post-Treatment Follow-up Period|Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.
11119365|NCT01695239|FG013|Participant Flow|Ixekizumab 80mg Q2W Post-Treatment Follow-up Period|Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
11119366|NCT01695239|OG000|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
11119367|NCT01695239|OG001|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
11119368|NCT01695239|OG002|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119369|NCT01695239|OG003|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119370|NCT01695239|OG001|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119371|NCT01695239|OG002|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119372|NCT01695239|EG000|Reported Event|Placebo (PBO) Double-Blind Period|Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.
11119373|NCT01695239|EG001|Reported Event|Adalimumab (ADA) Double-Blind Period|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24
11119374|NCT01695239|EG002|Reported Event|Ixe Q2W Double-Blind Period|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119375|NCT01695239|EG003|Reported Event|Ixe Q4W Double-Blind Period|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W or Placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11348380|NCT04178590|FG000|Participant Flow|All Study Participants|Study participants randomly assigned to receive two different treatments in cross - over study design: Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin and Scaling and root planing in conjunction with saline
11119376|NCT01695239|EG004|Reported Event|IR IXE Q4W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
11119377|NCT01695239|EG005|Reported Event|IR IXE Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119378|NCT01695239|EG006|Reported Event|IR PBO Washout|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
11119379|NCT01695239|EG007|Reported Event|PBO Washout|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
11119380|NCT01695239|EG008|Reported Event|IXE Q4W|"Ixekizumab every 4 weeks (IxeQ4W) and IR IxeQ4W participants received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 24 to Week 156.~Placebo and IR placebo (PBO) Washout participants re-randomized to Ixekizumab 80 mg Q4W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of alternating placebo for ixekizumab or ixekizumab Q2W from Week 26 to Week 156.~PBO Washout participants re-randomized to ixekizumab 80 mg Q4W received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 32 to Week 156."
11119381|NCT01695239|EG009|Reported Event|IXE Q2W|"Ixekizumab Q2W (IxeQ2W) and IR IxeQ2W participants received one SC injection of 80 mg of ixekizumab Q2W from Week 24 to Week 156.~Placebo and IR PBO Washout participants re-randomized to Ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 26 to Week 156.~PBO Washout participants re-randomized to ixekizumab 80 mg Q2W received one SC injection of 80 mg of ixekizumab Q2W from Week 32 to Week 156."
11119382|NCT01695239|EG010|Reported Event|PBO Post-Treatment Follow-Up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.
11119383|NCT01695239|EG011|Reported Event|Adalimumab Post-Treatment Follow-up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.
11119384|NCT01695239|EG012|Reported Event|IXE Q4W Post-Treatment Follow-up Period|Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.
11119385|NCT01695239|EG013|Reported Event|IXE Q2W Post-Treatment Follow-up Period|Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
11119386|NCT01695291|BG000|Baseline|Placebo|"Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.~Placebo: A placebo pill will be administered BID for 12 weeks."
11119387|NCT01695291|BG001|Baseline|Minocycline Augmentation|"Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.~Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks."
11119388|NCT01695291|BG002|Baseline|Total|Total of all reporting groups
11119389|NCT01695291|FG000|Participant Flow|Placebo|"Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.~Placebo: A placebo pill will be administered twice a day (BID) for 12 weeks."
11119390|NCT01695291|FG001|Participant Flow|Minocycline Augmentation|"Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.~Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks."
11119391|NCT01695291|OG000|Outcome|Placebo|"Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.~Placebo: A placebo pill will be administered BID for 12 weeks."
11348381|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin
11119392|NCT01695291|OG001|Outcome|Minocycline Augmentation|"Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.~Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks."
11119393|NCT01695291|EG000|Reported Event|Placebo|"Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.~Placebo: A placebo pill will be administered BID for 12 weeks."
11119394|NCT01695291|EG001|Reported Event|Minocycline Augmentation|"Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.~Minocycline: Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks."
11119395|NCT01695304|BG000|Baseline|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
11119396|NCT01695304|BG001|Baseline|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
11119397|NCT01695304|BG002|Baseline|Total|Total of all reporting groups
11119398|NCT01695304|FG000|Participant Flow|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
11119399|NCT01695304|FG001|Participant Flow|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
11119400|NCT01695304|OG000|Outcome|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
11119401|NCT01695304|OG001|Outcome|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
11119402|NCT01695304|OG000|Outcome|Intervention Group|Intervention group who received ceramic water filters
11119403|NCT01695304|OG001|Outcome|Control Group|Control Group who did not receive ceramic water filters (until after the trial ended)
11119404|NCT01695304|EG000|Reported Event|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
11119405|NCT01695304|EG001|Reported Event|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
11119406|NCT01695330|BG000|Baseline|Subcutaneous Bortezomib|
11119407|NCT01695330|FG000|Participant Flow|Subcutaneous Bortezomib|patients with MM who received treatment with a SC bortezomib-containing combination. The patients were required to have received a prior IV bortezomib containing combination regimen that differs from the SC bortezomib-containing treatment.
11119408|NCT01695330|FG001|Participant Flow||This is one-arm study.
11119409|NCT01695330|OG000|Outcome|Subcutaneous Bortezomib|Patients with MM who received treatment with a SC bortezomib-containing combination
11119410|NCT01695330|EG000|Reported Event|Subcutaneous Bortezomib|Bortezomib was administered SC at a dose of 1.0 mg/m2. Doses were administered on days 1, 4, 8, and 11 of a 28-day cycle. When administered subcutaneously, sites for each injection (thigh or abdomen) were rotated and reported. All other drugs used in combination with the SC bortezomib were recorded in the Case Report Forms along with their corresponding doses and schedules.
11119411|NCT01695369|BG000|Baseline|Overall Study Participants|Senofilcon A and Comfilcon A
11119412|NCT01695369|FG000|Participant Flow|Overall Study Participants|Senofilcon A and Comfilcon A
11119413|NCT01695369|OG000|Outcome|Comfilcon A|comfilcon A (CooperVision Biofinity®Sphere)
11119414|NCT01695369|OG001|Outcome|Senofilcon A|Senofilcon A (Vistakon Acuvue® Oasys)
11119415|NCT01695369|EG000|Reported Event|Overall Study Participants|Senofilcon A and Comfilcon A
11119416|NCT01695369|EG001|Reported Event|Comfilcon A|Comfilcon A / CooperVision Biofinity Sphere
11119417|NCT01695473|BG000|Baseline|Neoadjuvant BKM120|Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in OR scheduling, up to 7 additional days of BKM120 may be administered prior to surgery.
11119418|NCT01695473|FG000|Participant Flow|Neoadjuvant BKM120|Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in OR scheduling, up to 7 additional days of BKM120 may be administered prior to surgery.
11119419|NCT01695473|OG000|Outcome|Neoadjuvant BKM120|Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in OR scheduling, up to 7 additional days of BKM120 may be administered prior to surgery.
11119420|NCT01695473|OG000|Outcome|Neoadjuvant BKM120|"Twenty four men will receive 2 weeks of daily BKM120 prior to having radical prostatectomy~BKM120: Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in OR scheduling, up to 7 additional days of BKM120 may be administered prior to surgery."
11119421|NCT01695473|EG000|Reported Event|Neoadjuvant BKM120|Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in OR scheduling, up to 7 additional days of BKM120 may be administered prior to surgery.
11119422|NCT01695668|BG000|Baseline|Lotemax|Loteprednol Etabonate 0.5%
11119423|NCT01695668|BG001|Baseline|Restasis|Cyclosporine
11119424|NCT01695668|BG002|Baseline|Total|Total of all reporting groups
11119425|NCT01695668|FG000|Participant Flow|Lotemax|Loteprednol Etabonate 0.5%
11119426|NCT01695668|FG001|Participant Flow|Restasis|Cyclosporine
11119427|NCT01695668|OG000|Outcome|Lotemax|Loteprednol Etabonate 0.5%
11119428|NCT01695668|OG001|Outcome|Restasis|Cyclosporine
11119429|NCT01695668|EG000|Reported Event|Lotemax|"Loteprednol Etabonate 0.5%~Lotemax"
11119430|NCT01695668|EG001|Reported Event|Restasis|"Cyclosporine~Restasis"
11119431|NCT01695746|BG000|Baseline|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
11119432|NCT01695746|FG000|Participant Flow|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
11119433|NCT01695746|OG000|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
11119434|NCT01695746|OG000|Outcome|C.E.R.A (Continuous Erythropoietin Receptor Activator)|Participants with chronic renal anemia Stage III-IV, not on dialysis, receiving therapy with C.E.R.A. according to routine clinical practice were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 μg/kg of C.E.R.A once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 μg either once monthly; or 60, 100, or 180 μg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
11119435|NCT01695746|EG000|Reported Event|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
11119436|NCT01695772|BG000|Baseline|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
11119437|NCT01695772|FG000|Participant Flow|Bevacizumab|Participants received standard 5-Flurouracil (5-FU) based chemotherapy plus bevacizumab 5 milligrams per kilograms (mg/kg) intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
11348382|NCT04178590|OG001|Outcome|SRP + Placebo|The side of the mouth which will be treated with scaling and root planing in conjunction with saline
11119438|NCT01695772|OG000|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
11119439|NCT01695772|EG000|Reported Event|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
11119440|NCT01695954|BG000|Baseline|Arm A: (Pitavastatin and Efavirenz)|Subjects assigned to Arm A will receive pitavastatin 2 mg at bedtime and efavirenz 600 mg at bedtime.
11119441|NCT01695954|BG001|Baseline|Arm B: (Pitavastatin and Ritonavir-boosted Darunavir)|Subjects assigned to Arm B will receive pitavastatin 2 mg daily and darunavir 800 mg with ritonavir 100 mg daily.
11119442|NCT01695954|BG002|Baseline|Total|Total of all reporting groups
11119443|NCT01695954|FG000|Participant Flow|Arm A: (Pitavastatin and Efavirenz)|Subjects assigned to Arm A will receive pitavastatin 2 mg at bedtime and efavirenz 600 mg at bedtime.
11119444|NCT01695954|FG001|Participant Flow|Arm B: (Pitavastatin and Ritonavir-boosted Darunavir)|Subjects assigned to Arm B will receive pitavastatin 2 mg daily and darunavir 800 mg with ritonavir 100 mg daily.
11119445|NCT01695954|OG000|Outcome|Arm A: (Pitavastatin and Efavirenz)|Subjects assigned to Arm A will receive pitavastatin 2 mg at bedtime for the first 4 days, then efavirenz 600 mg at bedtime for the next 10 days and both pitavastatin 2 mg and efavirenz 600 mg at bedtime for the final 4 days. Blood will be drawn on days 0, 4, 14 and 18.
11119446|NCT01695954|OG001|Outcome|Arm B: (Pitavastatin and Darunavir)|Subjects in arm will receive pitavastatin 2 mg daily for the first 4 days, then darunavir 400 mg x 2 tabs and ritonavir 100 mg x 1 tab daily for the next 10 days and will receive both pitavastatin 2 mg and darunavir 400 mg x 2 tabs and ritonavir 100 mg x 1 tab daily for the final 4 days. Blood will be drawn on days 0, 4, 14, and 18.
11119447|NCT01695954|OG000|Outcome|Arm A: (Pitavastatin and Efavirenz)|Subjects assigned to Arm A will receive pitavastatin 2 mg at bedtime and efavirenz 600 mg at bedtime.
11119448|NCT01695954|OG001|Outcome|Arm B: (Pitavastatin and Ritonavir-boosted Darunavir)|Subjects assigned to Arm B will receive pitavastatin 2 mg daily and darunavir 800 mg with ritonavir 100 mg daily.
11119449|NCT01695954|EG000|Reported Event|Arm A: (Pitavastatin and Efavirenz)|Subjects assigned to Arm A will receive pitavastatin 2 mg at bedtime and efavirenz 600 mg at bedtime.
11119450|NCT01695954|EG001|Reported Event|Arm B: (Pitavastatin and Ritonavir-boosted Darunavir)|Subjects assigned to Arm B will receive pitavastatin 2 mg daily and darunavir 800 mg with ritonavir 100 mg daily.
11119451|NCT01695993|BG000|Baseline|Arm 1|Patients will receive only standard care
11119452|NCT01695993|BG001|Baseline|Arm 2|"Handout without expectancy- enhancing component~Relaxation MP3 without expectancy-enhancing component~Acupressure bands"
11119453|NCT01695993|BG002|Baseline|Arm 3|"Handout with expectancy- enhancing component~Relaxation MP3 with expectancy-enhancing component~Acupressure bands"
11119454|NCT01695993|BG003|Baseline|Total|Total of all reporting groups
11119455|NCT01695993|FG000|Participant Flow|Arm 1|Patients receive standard care only
11119456|NCT01695993|FG001|Participant Flow|Arm 2|"Handout without expectancy- enhancing component Relaxation MP3 without expectancy-enhancing component~- Acupressure bands"
11119457|NCT01695993|FG002|Participant Flow|Arm 3|Handout with expectancy- enhancing component Relaxation MP3 with expectancy- enhancing component Acupressure bands
11119458|NCT01695993|OG000|Outcome|Standard Care|Patients receive only standard care
11119459|NCT01695993|OG001|Outcome|Expectancy-Neutral Condition|"Handout without expectancy- enhancing component~Relaxation MP3 without expectancy-enhancing component~Acupressure bands"
11119460|NCT01695993|OG002|Outcome|Expectancy-Enhancing Condition|"Handout with expectancy-enhancing component~Relaxation MP3 with expectancy-enhancing component~Acupressure bands"
11119461|NCT01695993|EG000|Reported Event|Arm 1|Patients will receive only standard care
11119462|NCT01695993|EG001|Reported Event|Arm 2|"Patients receive:~Handout without expectancy- enhancing component~Relaxation MP3 without expectancy-enhancing component~Acupressure bands"
11119463|NCT01695993|EG002|Reported Event|Arm 3|"Patients receive:~Handout with expectancy- enhancing component~Relaxation MP3 with expectancy-enhancing component~Acupressure bands"
11119464|NCT01696032|BG000|Baseline|Stage 1: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119465|NCT01696032|BG001|Baseline|Stage 1: Guadecitabine+Carboplatin 45 mg/m2|Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
11119466|NCT01696032|BG002|Baseline|Stage 2: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119467|NCT01696032|BG003|Baseline|Stage 2: Treatment Choice|Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion. Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
11119468|NCT01696032|BG004|Baseline|Total|Total of all reporting groups
11119469|NCT01696032|FG000|Participant Flow|Stage 1: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119470|NCT01696032|FG001|Participant Flow|Stage 1: Guadecitabine+Carboplatin 45 mg/m2|Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
11119471|NCT01696032|FG002|Participant Flow|Stage 2: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119472|NCT01696032|FG003|Participant Flow|Stage 2: Treatment Choice|Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); pegylated liposomal doxorubicin (PLD) (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion). Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
11119473|NCT01696032|OG000|Outcome|Stage 1: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119474|NCT01696032|OG001|Outcome|Stage 1: Guadecitabine+Carboplatin 45 mg/m2|Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
11119475|NCT01696032|OG000|Outcome|Stage 2: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119476|NCT01696032|OG001|Outcome|Stage 2: Treatment Choice|Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
11119477|NCT01696032|OG002|Outcome|Stage 2: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119478|NCT01696032|OG003|Outcome|Stage 2: Treatment Choice|Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
11119479|NCT01696032|OG004|Outcome|Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2|Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
11119480|NCT01696032|EG000|Reported Event|Stage 1: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119481|NCT01696032|EG001|Reported Event|Stage 1: Guadecitabine+Carboplatin 45 mg/m2|Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
11119482|NCT01696032|EG002|Reported Event|Stage 2: Guadecitabine+Carboplatin 30 mg/m2|Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
11119483|NCT01696032|EG003|Reported Event|Stage 2: Treatment Choice|Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
11119484|NCT01696032|EG004|Reported Event|Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2|Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
11119485|NCT01696045|BG000|Baseline|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
11119486|NCT01696045|BG001|Baseline|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
11119487|NCT01696045|BG002|Baseline|Total|Total of all reporting groups
11119488|NCT01696045|FG000|Participant Flow|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
11119489|NCT01696045|FG001|Participant Flow|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
11119490|NCT01696045|OG000|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
11119491|NCT01696045|OG001|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
11119492|NCT01696045|EG000|Reported Event|IPILIMUMAB 3 MG/KG|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
11119493|NCT01696045|EG001|Reported Event|IPILIMUMAB 10 MG/KG|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
11119494|NCT01696058|BG000|Baseline|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
11119495|NCT01696058|BG001|Baseline|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
11119496|NCT01696058|BG002|Baseline|Total|Total of all reporting groups
11119497|NCT01696058|FG000|Participant Flow|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
11119498|NCT01696058|FG001|Participant Flow|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
10848773|NCT00291447|OG002|Outcome|Cohort 3|"Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11119499|NCT01696058|OG000|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
11119500|NCT01696058|OG001|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
11119501|NCT01696058|EG000|Reported Event|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
11119502|NCT01696058|EG001|Reported Event|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
11119503|NCT01696071|BG000|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
11119504|NCT01696071|FG000|Participant Flow|Tio R2.5 Twice Daily (BID) / Tio R5 Once Daily (QD)|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.~Treatment 1: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium-Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg) Treatment 2: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium-Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg)"
11119505|NCT01696071|FG001|Participant Flow|Tio R5 QD / Tio R2.5 BID|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.~Treatment 1: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium-Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg) Treatment 2: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium-Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg)"
11119506|NCT01696071|OG000|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with inhaled corticosteroid (iCS).
11119507|NCT01696071|OG001|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
11119508|NCT01696071|OG000|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
11119509|NCT01696071|EG000|Reported Event|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
11119510|NCT01696071|EG001|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
11119511|NCT01696084|BG000|Baseline|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
11119512|NCT01696084|BG001|Baseline|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
11119513|NCT01696084|BG002|Baseline|Total|Total of all reporting groups
11119514|NCT01696084|FG000|Participant Flow|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
11119515|NCT01696084|FG001|Participant Flow|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
11119516|NCT01696084|OG000|Outcome|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
11119517|NCT01696084|OG001|Outcome|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
11119518|NCT01696084|EG000|Reported Event|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
11119519|NCT01696084|EG001|Reported Event|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
11119520|NCT01696188|BG000|Baseline|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
11119521|NCT01696188|BG001|Baseline|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plan approach.~interscalene nerve catheter"
11119522|NCT01696188|BG002|Baseline|Total|Total of all reporting groups
11119523|NCT01696188|FG000|Participant Flow|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
11119524|NCT01696188|FG001|Participant Flow|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
11119525|NCT01696188|OG000|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
11119526|NCT01696188|OG001|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
11119527|NCT01696188|EG000|Reported Event|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
11119528|NCT01696188|EG001|Reported Event|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
11119529|NCT01696214|BG000|Baseline|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
11119530|NCT01696214|BG001|Baseline|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.~Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
11119531|NCT01696214|BG002|Baseline|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
11119532|NCT01696214|BG003|Baseline|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
11119533|NCT01696214|BG004|Baseline|Total|Total of all reporting groups
11119534|NCT01696214|FG000|Participant Flow|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
11119535|NCT01696214|FG001|Participant Flow|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.~Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks"
11119536|NCT01696214|FG002|Participant Flow|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
11119537|NCT01696214|FG003|Participant Flow|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
11119538|NCT01696214|OG000|Outcome|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.~ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks."
11119539|NCT01696214|OG001|Outcome|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.~Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks"
11119540|NCT01696214|OG002|Outcome|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.~Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks."
11119541|NCT01696214|OG003|Outcome|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo"
11119542|NCT01696214|OG000|Outcome|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and placebo montelukast.~ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks."
11119543|NCT01696214|OG001|Outcome|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.~Theophylline 400 mg: Participants will be assigned to theophylline once a day for 24 weeks"
11119544|NCT01696214|OG002|Outcome|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.~Montelukast 10mg: Participants will be assigned to montelukast once a day for 24 weeks."
11119545|NCT01696214|OG003|Outcome|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.~Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo"
11119546|NCT01696214|OG000|Outcome|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
11119547|NCT01696214|OG001|Outcome|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.~Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks"
11119548|NCT01696214|OG002|Outcome|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
11119549|NCT01696214|OG003|Outcome|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
11119550|NCT01696214|EG000|Reported Event|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
11119551|NCT01696214|EG001|Reported Event|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.~Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
11119552|NCT01696214|EG002|Reported Event|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
11119553|NCT01696214|EG003|Reported Event|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
11119554|NCT01696279|BG000|Baseline|Overall Study|Study was conducted in 3 parts, participants aged 10 to 12 years received 500 milligram (mg) and greater than (>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder respectively during part 1, followed by part 2 during which participants received calcium carbonate tablet for 8 weeks until a maximum daily dose of 6500 mg was reached (part 2a-Treatment period 1) and then received lanthanum carbonate oral powder for 8 weeks until a daily dose of 1500 mg was reached (part 2a-Treatment period 2). Eligible participants received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg, which was titrated bi-weekly until a daily dose of 3000 mg was achieved (part 2b). Participants who completed part 2 continued the same treatment for additional 6 months during the part 3.
11119555|NCT01696279|FG000|Participant Flow|Part 1: Single Dose Lanthanum Carbonate|Participants aged 10 to 12 years received 500 milligram (mg) and greater than (>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder in the morning following breakfast.
11119556|NCT01696279|FG001|Participant Flow|Part 2a: Calcium Carbonate, Then Lanthanum Carbonate (8 Weeks)|Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks calcium carbonate, followed by 3 weeks of washout period (if necessary). At the end of first 8-week treatment period of part 2a, participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks lanthanum carbonate treatment period.
11119557|NCT01696279|FG002|Participant Flow|Part 2b: Lanthanum Carbonate (8 Weeks)|Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
11119558|NCT01696279|FG003|Participant Flow|Part 3: Lanthanum Carbonate (6 Months)|Participants who completed in Part 2 (2a or 2b) could continue to receive lanthanum carbonate for an additional 6 months. Dosage of lanthanum carbonate was determined by the investigator based on serum phosphate levels taken at each study visit up to a maximum dose of 3000 mg/day.
11119559|NCT01696279|OG000|Outcome|Part 2 + Part 3: Lanthanum Carbonate|Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
11119560|NCT01696279|OG000|Outcome|Part 2: Calcium Carbonate|Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).
11119561|NCT01696279|OG001|Outcome|Part 2: Lanthanum Carbonate|Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
11348383|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|"Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin~SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing at baseline - the assessment after 1 month."
11119562|NCT01696279|OG001|Outcome|Part 2 + Part 3: Lanthanum Carbonate|Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
11119563|NCT01696279|EG000|Reported Event|Part 1: Lanthanum Carbonate|Participants aged 10 to 12 years received 500 mg and greater than (>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder.
11119564|NCT01696279|EG001|Reported Event|Part 2: Calcium Carbonate|Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).
11119565|NCT01696279|EG002|Reported Event|Part 2 + Part 3: Lanthanum Carbonate|Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
11119566|NCT01696357|BG000|Baseline|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
11119567|NCT01696357|BG001|Baseline|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
11119568|NCT01696357|BG002|Baseline|Total|Total of all reporting groups
11119569|NCT01696357|FG000|Participant Flow|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
11119570|NCT01696357|FG001|Participant Flow|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
11119571|NCT01696357|OG000|Outcome|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
11119572|NCT01696357|OG001|Outcome|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
11119573|NCT01696357|EG000|Reported Event|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
11119574|NCT01696357|EG001|Reported Event|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
11119575|NCT01696396|BG000|Baseline|Placebo|Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119576|NCT01696396|BG001|Baseline|Abrilumab 21 mg Q4W|Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
11119577|NCT01696396|BG002|Baseline|Abrilumab 70 mg Q4W|Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119578|NCT01696396|BG003|Baseline|Abrilumab 210 mg|Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119579|NCT01696396|BG004|Baseline|Total|Total of all reporting groups
11119580|NCT01696396|FG000|Participant Flow|Placebo/Abrilumab 210 mg Q3M|"Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks."
11119581|NCT01696396|FG001|Participant Flow|Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M|"Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks."
11119582|NCT01696396|FG002|Participant Flow|Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M|"Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks."
11119583|NCT01696396|FG003|Participant Flow|Abrilumab 210 mg/Abrilumab 210 mg Q3M|"Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.~During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks."
11119584|NCT01696396|OG000|Outcome|Placebo|Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119585|NCT01696396|OG001|Outcome|Abrilumab 21 mg Q4W|Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
11119586|NCT01696396|OG002|Outcome|Abrilumab 70 mg Q4W|Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119587|NCT01696396|OG003|Outcome|Abrilumab 210 mg|Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119588|NCT01696396|EG000|Reported Event|DB Period: Placebo|Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind (DB) treatment period.
11119589|NCT01696396|EG001|Reported Event|DB Period: Abrilumab 21 mg Q4W|Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119590|NCT01696396|EG002|Reported Event|DB Period: Abrilumab 70 mg Q4W|Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119591|NCT01696396|EG003|Reported Event|DB Period: Abrilumab 210 mg|Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
11119592|NCT01696396|EG004|Reported Event|OL Period: Placebo/Abrilumab 210 mg Q3M|Participants who received placebo during the double-blind treatment period received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks during the open-label (OL) treatment period.
11119593|NCT01696396|EG005|Reported Event|OL Period: Abrilumab 21 mg Q4W/210 mg Q3M|During the open-label period, participants who received 21 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks.
11119594|NCT01696396|EG006|Reported Event|OL Period: Abrilumab 70 mg Q4W/210 mg Q3M|Participants who received 70 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
11119595|NCT01696396|EG007|Reported Event|Period: Abrilumab 210 mg/210 mg Q3M|Participants who received 210 mg abrilumab during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
11119596|NCT01696643|BG000|Baseline|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
11119597|NCT01696643|BG001|Baseline|Placebo|Placebo, administered orally, BID for 52 weeks
11119598|NCT01696643|BG002|Baseline|Total|Total of all reporting groups
11119599|NCT01696643|FG000|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks
11119600|NCT01696643|FG001|Participant Flow|Placebo|Placebo, administered orally, BID for 52 weeks
11119601|NCT01696643|OG000|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
11119602|NCT01696643|OG001|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
11119603|NCT01696643|EG000|Reported Event|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
11119604|NCT01696643|EG001|Reported Event|Placebo|Placebo, administered orally, BID for 52 weeks
11119605|NCT01696695|BG000|Baseline|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
11119606|NCT01696695|FG000|Participant Flow|Metastatic Colorectal Carcinoma (mCRC) Participants|Newly diagnosed metastatic colorectal carcinoma (mCRC) participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
11119607|NCT01696695|OG000|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
11119608|NCT01696695|EG000|Reported Event|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
11119609|NCT01696760|BG000|Baseline|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
11119610|NCT01696760|BG001|Baseline|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
11119611|NCT01696760|BG002|Baseline|Total|Total of all reporting groups
11119612|NCT01696760|FG000|Participant Flow|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
11119613|NCT01696760|FG001|Participant Flow|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
11119614|NCT01696760|OG000|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
11119615|NCT01696760|OG001|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
11119616|NCT01696760|EG000|Reported Event|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
11119617|NCT01696760|EG001|Reported Event|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
11119618|NCT01696773|BG000|Baseline|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28
11119619|NCT01696773|BG001|Baseline|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28
11119620|NCT01696773|BG002|Baseline|Total|Total of all reporting groups
11119621|NCT01696773|FG000|Participant Flow|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed
11119622|NCT01696773|FG001|Participant Flow|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.
11119623|NCT01696773|OG000|Outcome|Tangerine Tomato Juice|"Tangerine tomato juice will be fed~Tangerine tomato juice: Post-prandial feeding study"
11119624|NCT01696773|OG001|Outcome|Red Tomato Juice|"Red tomato juice will be fed~Red tomato juice: Post-prandial feeding study"
11119625|NCT01696773|EG000|Reported Event|Tangerine Tomato Juice|"Tangerine tomato juice will be fed~Tangerine tomato juice: Post-prandial feeding study"
11119626|NCT01696773|EG001|Reported Event|Red Tomato Juice|"Red tomato juice will be fed~Red tomato juice: Post-prandial feeding study"
11119627|NCT01696877|BG000|Baseline|Degarelix|"Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow."
11119628|NCT01696877|BG001|Baseline|Cyclophosphamide, GVAX and Degarelix|"Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.~Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.~GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer"
11119629|NCT01696877|BG002|Baseline|Total|Total of all reporting groups
11119630|NCT01696877|FG000|Participant Flow|Degarelix|"Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow."
11119631|NCT01696877|FG001|Participant Flow|Cyclophosphamide, GVAX and Degarelix|"Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.~Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.~GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer"
11119632|NCT01696877|OG000|Outcome|Degarelix|"Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow."
11119633|NCT01696877|OG001|Outcome|Cyclophosphamide, GVAX and Degarelix|"Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.~Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.~GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer"
11119634|NCT01696877|OG001|Outcome|Cyclophosphamide, GVAX and Degarelix|"Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.~Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.~GVAX: GVAX is granulocytemacrophage -colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer"
11119635|NCT01696877|OG001|Outcome|Cyclophosphamide, GVAX and Degarelix|"Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.~Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.~GVAX: GVAX is Granulocyte-macrophage-colony stimulating factor-secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer"
11119636|NCT01696877|EG000|Reported Event|Degarelix|"Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow."
11119637|NCT01696877|EG001|Reported Event|Cyclophosphamide, GVAX and Degarelix|"Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.~degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.~Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.~GVAX: GVAX is GM-CSF-secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer"
11348384|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing at baseline. The assessment after 1 month."
11348385|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|"Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin~SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing at baseline - the assessment after 3 months."
11119638|NCT01696929|BG000|Baseline|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
11119639|NCT01696929|FG000|Participant Flow|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of Tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of Tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacological Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
11119640|NCT01696929|OG000|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
11119641|NCT01696929|EG000|Reported Event|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
11119642|NCT01696942|BG000|Baseline|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
11119643|NCT01696942|BG001|Baseline|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
11119644|NCT01696942|BG002|Baseline|Total|Total of all reporting groups
11119645|NCT01696942|FG000|Participant Flow|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
11119646|NCT01696942|FG001|Participant Flow|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
11119647|NCT01696942|OG000|Outcome|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
11119648|NCT01696942|OG001|Outcome|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
11119649|NCT01696942|EG000|Reported Event|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
11119650|NCT01696942|EG001|Reported Event|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
11119651|NCT01696955|BG000|Baseline|Arm I (Cetuximab and Tivantinib)|"Patients receive cetuximab 500mg/m2 IV over 60-120 minutes on days 1 and 15 and tivantinib 360mg PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV~Tivantinib: Given PO"
11119652|NCT01696955|BG001|Baseline|Arm II (Cetuximab)|"Patients receive cetuximab 500mg/m2 IV over 60-120 minutes on days 1 and 15. Patients who fail (progress) on cetuximab as a single agent may then receive single agent tivantinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV"
11119653|NCT01696955|BG002|Baseline|Total|Total of all reporting groups
11119654|NCT01696955|FG000|Participant Flow|Arm I (Cetuximab and Tivantinib)|"Patients receive cetuximab 500mg/m2 IV over 60-120 minutes on days 1 and 15 and tivantinib 360mg PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV~Tivantinib: Given PO"
11119655|NCT01696955|FG001|Participant Flow|Arm II (Cetuximab)|"Patients receive cetuximab 500 mg/m2 IV over 60-120 minutes on days 1 and 15. Patients who fail (progress) on cetuximab as a single agent may then receive single agent tivantinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV"
11119656|NCT01696955|OG000|Outcome|Arm I (Cetuximab and Tivantinib)|"Patients receive cetuximab 500mg/m2 IV over 60-120 minutes on days 1 and 15 and tivantinib 360mg PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV~Tivantinib: Given PO"
11119657|NCT01696955|OG001|Outcome|Arm II (Cetuximab)|"Patients receive cetuximab 500mg/m2 IV over 60-120 minutes on days 1 and 15. Patients who fail (progress) on cetuximab as a single agent may then receive single agent tivantinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV"
11119658|NCT01696955|OG000|Outcome|Arm I (Cetuximab and Tivantinib)|"Patients receive cetuximab 500 mg/m2 IV over 60-120 minutes on days 1 and 15 and tivantinib 360 mg PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV~Tivantinib: Given PO"
11119659|NCT01696955|OG001|Outcome|Arm II (Cetuximab)|"Patients receive cetuximab 500 mg/m2 IV over 60-120 minutes on days 1 and 15. Patients who fail (progress) on cetuximab as a single agent may then receive single agent tivantinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV"
11119660|NCT01696955|OG000|Outcome|Arm I (Cetuximab and Tivantinib)|"Patients receive cetuximab 500 mg/m2 IV over 60-120 minutes on days 1 and 15 and tivantinib 360mg PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV~Tivantinib: Given PO"
11119661|NCT01696955|OG000|Outcome|Arm I (Cetuximab and Tivantinib)|"Patients receive cetuximab IV over 60-120 minutes on days 1 and 15 and tivantinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
11119662|NCT01696955|OG001|Outcome|Arm II (Cetuximab)|"Patients receive cetuximab IV over 60-120 minutes on days 1 and 15. Patients who fail cetuximab as a single agent may receive single agent tivantinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11119663|NCT01696955|OG001|Outcome|Tivantinib After Cetuximab Failure|ARQ 197 (tivantinib) 360mg PO BID on days 1-28.
11119664|NCT01696955|EG000|Reported Event|Arm I (Cetuximab and Tivantinib)|"Patients receive cetuximab 500mg/m2 IV over 60-120 minutes on days 1 and 15 and tivantinib 360mg PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV~Tivantinib: Given PO"
11119665|NCT01696955|EG001|Reported Event|Arm II (Cetuximab)|"Patients receive cetuximab 500mg/m2 IV over 60-120 minutes on days 1 and 15. Patients who fail (progress) on cetuximab as a single agent may then receive single agent tivantinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cetuximab: Given IV"
11119666|NCT01696955|EG002|Reported Event|Single-agent Tivantinib After Failure of Cetuximab|Patients receive cetuximab 500mg/m2 IV over 60-120 minutes on days 1 and 15.
11348386|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing at baseline - the assessment after 3 months."
11119697|NCT01697319|BG000|Baseline|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
11119698|NCT01697319|FG000|Participant Flow|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
11119699|NCT01697319|OG000|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
11119700|NCT01697319|EG000|Reported Event|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
11119701|NCT01697345|BG000|Baseline|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
11119702|NCT01697345|FG000|Participant Flow|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
11119703|NCT01697345|OG000|Outcome|FSFI Total Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
11119704|NCT01697345|OG001|Outcome|FSFI Total Score (Postteset)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
11119705|NCT01697345|OG000|Outcome|FSFI Desire Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
11348387|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|"Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin~SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing at baseline - the assessment after 6 month."
11119706|NCT01697345|OG001|Outcome|FSFI Desire Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
11119707|NCT01697345|OG000|Outcome|FSFI Arousal Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
11119708|NCT01697345|OG001|Outcome|FSFI Arousal Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
11119709|NCT01697345|OG000|Outcome|FSFI Lubrication Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
11119710|NCT01697345|OG001|Outcome|FSFI Lubrication Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
11119711|NCT01697345|OG000|Outcome|FSFI Orgasm Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
11119712|NCT01697345|OG001|Outcome|FSFI Orgasm Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
11119713|NCT01697345|OG000|Outcome|FSFI Satisfaction Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
11119714|NCT01697345|OG001|Outcome|FSFI Satisfaction Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
11119715|NCT01697345|OG000|Outcome|FSFI Pain Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
11119716|NCT01697345|OG001|Outcome|FSFI Pain Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
11119717|NCT01697345|OG000|Outcome|Continued Vaginal Testosterone Therapy|Participants who chose to continue vaginal testosterone therapy upon completion of the study.
11119718|NCT01697345|OG001|Outcome|Did Not Continue Vaginal Testosterone Therapy|Participants who chose not to continue vaginal testosterone upon completion of the study.
11119719|NCT01697345|EG000|Reported Event|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
11119720|NCT01697358|BG000|Baseline|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
11119721|NCT01697358|BG001|Baseline|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
11119722|NCT01697358|BG002|Baseline|Total|Total of all reporting groups
11119723|NCT01697358|FG000|Participant Flow|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
11119724|NCT01697358|FG001|Participant Flow|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
11119725|NCT01697358|OG000|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
11119726|NCT01697358|OG001|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
11119727|NCT01697358|EG000|Reported Event|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
11119728|NCT01697358|EG001|Reported Event|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
11119729|NCT01697449|BG000|Baseline|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
11119730|NCT01697449|FG000|Participant Flow|Colorectal Cancer (CRC) Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
11119731|NCT01697449|OG000|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
11119732|NCT01697449|OG000|Outcome|Resectable/Potentially Resectable CRC at Baseline|Participants with resectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
11119733|NCT01697449|OG001|Outcome|Unresectable CRC at Baseline|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
11119734|NCT01697449|OG000|Outcome|Unresectable|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
11119735|NCT01697449|EG000|Reported Event|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
11119736|NCT01697462|BG000|Baseline|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
11119737|NCT01697462|FG000|Participant Flow|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
11119738|NCT01697462|OG000|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
11119739|NCT01697462|EG000|Reported Event|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
11119740|NCT01697501|BG000|Baseline|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
11119741|NCT01697501|FG000|Participant Flow|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
11119742|NCT01697501|OG000|Outcome|"CC"|at IL28B genotype rs12979860
11119743|NCT01697501|OG001|Outcome|"TC"|at IL28B genotype rs12979860
11119744|NCT01697501|OG002|Outcome|"TT"|at IL28B genotype rs12979860
11119745|NCT01697501|OG003|Outcome|"TC+TT"|at IL28B genotype rs12979860
11119746|NCT01697501|OG004|Outcome|"Overall"|at IL28B genotype rs12979860
11119747|NCT01697501|OG000|Outcome|"TT"|at IL28B genotype rs8099917
11119748|NCT01697501|OG001|Outcome|"GT"|at IL28B genotype rs8099917
11119749|NCT01697501|OG002|Outcome|"GG"|at IL28B genotype rs8099917
11119750|NCT01697501|OG003|Outcome|"GT+GG"|at IL28B genotype rs8099917
11119751|NCT01697501|OG004|Outcome|"Overall"|at IL28B genotype rs8099917
11119752|NCT01697501|EG000|Reported Event|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
11348388|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing at baseline. The assessment after 6 month."
11119753|NCT01697579|BG000|Baseline|Fosaprepitant 5 mg/Kg-Cycle 1|Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119754|NCT01697579|BG001|Baseline|Fosaprepitant 3 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119755|NCT01697579|BG002|Baseline|Fosaprepitant 1.2 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119756|NCT01697579|BG003|Baseline|Fosaprepitant 0.4 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119757|NCT01697579|BG004|Baseline|Placebo Control-Cycle 1|Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119758|NCT01697579|BG005|Baseline|Total|Total of all reporting groups
11119759|NCT01697579|FG000|Participant Flow|Fosaprepitant 5 mg/Kg-Cycle 1|Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119760|NCT01697579|FG001|Participant Flow|Fosaprepitant 3 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119761|NCT01697579|FG002|Participant Flow|Fosaprepitant 1.2 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119762|NCT01697579|FG003|Participant Flow|Fosaprepitant 0.4 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119763|NCT01697579|FG004|Participant Flow|Placebo Control-Cycle 1|Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119764|NCT01697579|FG005|Participant Flow|Fosaprepitant 5 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
11119765|NCT01697579|FG006|Participant Flow|Fosaprepitant 3 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
11119766|NCT01697579|OG000|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119767|NCT01697579|OG000|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119768|NCT01697579|OG001|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119769|NCT01697579|OG002|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119770|NCT01697579|OG003|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119771|NCT01697579|OG000|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119772|NCT01697579|OG001|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119773|NCT01697579|OG002|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119774|NCT01697579|OG003|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119775|NCT01697579|OG000|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119776|NCT01697579|OG001|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119777|NCT01697579|OG002|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
11119778|NCT01697579|OG000|Outcome|Fosaprepitant 5 mg/Kg-Cycle 1|Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119779|NCT01697579|OG001|Outcome|Fosaprepitant 3 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119780|NCT01697579|OG002|Outcome|Fosaprepitant 1.2 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119781|NCT01697579|OG003|Outcome|Fosaprepitant 0.4 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119782|NCT01697579|OG004|Outcome|Placebo Control-Cycle 1|Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119783|NCT01697579|OG000|Outcome|Fosaprepitant 5 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
11119784|NCT01697579|OG001|Outcome|Fosaprepitant 3 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
11119785|NCT01697579|EG000|Reported Event|Fosaprepitant 0.4 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119786|NCT01697579|EG001|Reported Event|Fosaprepitant 1.2 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119787|NCT01697579|EG002|Reported Event|Fosaprepitant 3 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11119788|NCT01697579|EG003|Reported Event|Fosaprepitant 5 mg/Kg-Cycle 1|Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11119789|NCT01697579|EG004|Reported Event|Placebo Control-Cycle 1|Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
11348389|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing
11005947|NCT01083654|EG000|Reported Event|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
11005948|NCT01083654|EG001|Reported Event|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
11005949|NCT01083667|BG000|Baseline|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
11005950|NCT01083667|FG000|Participant Flow|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
11005951|NCT01083667|OG000|Outcome|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
11005952|NCT01083667|EG000|Reported Event|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
11005953|NCT01083680|BG000|Baseline|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
11005954|NCT01083680|FG000|Participant Flow|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
11005955|NCT01083680|OG000|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
11005956|NCT01083680|EG000|Reported Event|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
11005957|NCT01083693|BG000|Baseline|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
11005958|NCT01083693|BG001|Baseline|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
11005959|NCT01083693|BG002|Baseline|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
11005960|NCT01083693|BG003|Baseline|Total|Total of all reporting groups
11005961|NCT01083693|FG000|Participant Flow|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
11005962|NCT01083693|FG001|Participant Flow|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
11005963|NCT01083693|FG002|Participant Flow|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
11005964|NCT01083693|OG000|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
11005965|NCT01083693|OG001|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
11005966|NCT01083693|OG002|Outcome|Total|
11005967|NCT01083693|OG002|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
11005968|NCT01083693|OG003|Outcome|Total|
11005969|NCT01083693|OG000|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
11005970|NCT01083693|EG000|Reported Event|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
11005971|NCT01083693|EG001|Reported Event|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
11005972|NCT01083693|EG002|Reported Event|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
11005973|NCT01083693|EG003|Reported Event|Total|
11005974|NCT01083706|BG000|Baseline|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
11348390|NCT04178590|OG001|Outcome|SRP + Placebo|"The side of the mouth which will be treated with scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing"
11119790|NCT01697579|EG005|Reported Event|Fosaprepitant 3 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
11119791|NCT01697579|EG006|Reported Event|Fosaprepitant 5 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
11119792|NCT01697592|BG000|Baseline|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
11119793|NCT01697592|BG001|Baseline|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119794|NCT01697592|BG002|Baseline|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
11119795|NCT01697592|BG003|Baseline|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119796|NCT01697592|BG004|Baseline|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119797|NCT01697592|BG005|Baseline|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
11119798|NCT01697592|BG006|Baseline|Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119799|NCT01697592|BG007|Baseline|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study.
11119800|NCT01697592|BG008|Baseline|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119801|NCT01697592|BG009|Baseline|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119802|NCT01697592|BG010|Baseline|Total|Total of all reporting groups
11119803|NCT01697592|FG000|Participant Flow|Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
11119804|NCT01697592|FG001|Participant Flow|Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119805|NCT01697592|FG002|Participant Flow|Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
11119806|NCT01697592|FG003|Participant Flow|Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119807|NCT01697592|FG004|Participant Flow|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
11119808|NCT01697592|FG005|Participant Flow|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
11119809|NCT01697592|FG006|Participant Flow|Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119810|NCT01697592|FG007|Participant Flow|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
11119811|NCT01697592|FG008|Participant Flow|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119812|NCT01697592|FG009|Participant Flow|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119813|NCT01697592|OG000|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
11119814|NCT01697592|OG001|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119815|NCT01697592|OG002|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
11119816|NCT01697592|OG003|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119817|NCT01697592|OG004|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119818|NCT01697592|OG005|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
11119819|NCT01697592|OG006|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119820|NCT01697592|OG007|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
11119821|NCT01697592|OG008|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119822|NCT01697592|OG009|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119823|NCT01697592|OG000|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
11119824|NCT01697592|OG001|Outcome|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119825|NCT01697592|OG002|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
11119826|NCT01697592|OG003|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119827|NCT01697592|OG004|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119828|NCT01697592|OG005|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued prestudy basal medication of SU throughout the duration of the study."
11119829|NCT01697592|OG006|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued pre-study basal medication of Gln throughout the duration of the study."
11119830|NCT01697592|OG007|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG throughout the duration of the study.
11119831|NCT01697592|OG008|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119832|NCT01697592|OG009|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119833|NCT01697592|OG007|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG. throughout the duration of the study.
11119834|NCT01697592|OG006|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln. throughout the duration of the study.
11119835|NCT01697592|EG000|Reported Event|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
11119836|NCT01697592|EG001|Reported Event|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119837|NCT01697592|EG002|Reported Event|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
11119838|NCT01697592|EG003|Reported Event|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119839|NCT01697592|EG004|Reported Event|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119840|NCT01697592|EG005|Reported Event|Placebo/ABM (Phase A)|Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.
11119841|NCT01697592|EG006|Reported Event|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
11119842|NCT01697592|EG007|Reported Event|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
11119843|NCT01697592|EG008|Reported Event|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
11119844|NCT01697592|EG009|Reported Event|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
11119845|NCT01697592|EG010|Reported Event|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
11119846|NCT01697592|EG011|Reported Event|Omarigliptin 25mg/ABM (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued any prestudy basal medications throughout the duration of the study."
11119847|NCT01697696|BG000|Baseline|NVA237|12.5 μg twice-daily
11119848|NCT01697696|BG001|Baseline|QAB149|75 μg once-daily
11119849|NCT01697696|BG002|Baseline|Total|Total of all reporting groups
11119850|NCT01697696|FG000|Participant Flow|NVA237|12.5 μg twice-daily
11119851|NCT01697696|FG001|Participant Flow|QAB149|75 μg once-daily
11119852|NCT01697696|OG000|Outcome|NVA237|12.5 μg twice-daily
11119853|NCT01697696|OG001|Outcome|QAB149|75 μg once-daily
11119854|NCT01697696|EG000|Reported Event|NVA237|12.5 μg twice-daily
11119855|NCT01697696|EG001|Reported Event|QAB149|75 μg once-daily
11119856|NCT01697709|BG000|Baseline|Placebo|"Placebo medication~Placebo: placebo capsules"
11119857|NCT01697709|BG001|Baseline|Quetiapine|"Quetiapine treatment~Quetiapine: Quetiapine pharmacotherapy for cannabis dependence"
11119858|NCT01697709|BG002|Baseline|Total|Total of all reporting groups
11119859|NCT01697709|FG000|Participant Flow|Placebo|"Placebo medication~Placebo: placebo capsules"
11119860|NCT01697709|FG001|Participant Flow|Quetiapine|"Quetiapine treatment~Quetiapine: Quetiapine pharmacotherapy for cannabis dependence"
11119861|NCT01697709|OG000|Outcome|Placebo|"Placebo medication~Placebo: placebo capsules"
11119862|NCT01697709|OG001|Outcome|Quetiapine|"Quetiapine treatment~Quetiapine: Quetiapine pharmacotherapy for cannabis dependence"
11119863|NCT01697709|EG000|Reported Event|Placebo|"Placebo medication~Placebo: placebo capsules"
11119864|NCT01697709|EG001|Reported Event|Quetiapine|"Quetiapine treatment~Quetiapine: Quetiapine pharmacotherapy for cannabis dependence"
11119865|NCT01697748|BG000|Baseline|Telfa Pad Dressing|"Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.~Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7."
11119866|NCT01697748|BG001|Baseline|Silver-impregnated Dressing|"Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.~Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7."
11119867|NCT01697748|BG002|Baseline|Total|Total of all reporting groups
11119868|NCT01697748|FG000|Participant Flow|Telfa Pad Dressing|"Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.~Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7."
11119869|NCT01697748|FG001|Participant Flow|Silver-impregnated Dressing|"Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.~Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7."
11119870|NCT01697748|OG000|Outcome|Telfa Pad Dressing|"Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.~Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7."
11119871|NCT01697748|OG001|Outcome|Silver-impregnated Dressing|"Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.~Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7."
11119872|NCT01697748|EG000|Reported Event|Telfa Pad Dressing|"Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.~Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7."
11119873|NCT01697748|EG001|Reported Event|Silver-impregnated Dressing|"Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.~Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7."
11119874|NCT01697956|BG000|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
11119875|NCT01697956|BG001|Baseline|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
11119876|NCT01697956|BG002|Baseline|Total|Total of all reporting groups
11119877|NCT01697956|FG000|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
11119878|NCT01697956|FG001|Participant Flow|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
11119879|NCT01697956|OG000|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
11119880|NCT01697956|OG001|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
11119881|NCT01697956|OG000|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
11119882|NCT01697956|OG001|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
11119883|NCT01697956|OG000|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
11119884|NCT01697956|OG001|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
11119885|NCT01697956|OG002|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
11119886|NCT01697956|OG003|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
11119887|NCT01697956|EG000|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
11119888|NCT01697956|EG001|Reported Event|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
11119889|NCT01697969|BG000|Baseline|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
11119890|NCT01697969|FG000|Participant Flow|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
11119891|NCT01697969|OG000|Outcome|Left Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
11119892|NCT01697969|OG001|Outcome|Right Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
11119893|NCT01697969|EG000|Reported Event|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
11119894|NCT01698008|BG000|Baseline|Mobile Application Diabetes Doctor|The intervention group sent blood glucoses once a month using the mobile phone app, Diabetes Doctor. Subjects were seen at initial, 3 month, and 6 month visits. They received HbA1c on each visit. After 3 months, a Diabetes Quality of Life (QOL)survey was completed. A Usability and Satisfaction of Diabetes Doctor (USDD) survey was given to assess use of the mobile app. At the 3 month interval the control group will be given the opportunity to use the mobile application. QOL and USDD was given at the conclusion of the study.
11119895|NCT01698008|BG001|Baseline|Standard of Care Group|This group did not use the mobile app to communicate with their physician about their blood sugars. They continued with their current care.
11119896|NCT01698008|BG002|Baseline|Total|Total of all reporting groups
11119897|NCT01698008|FG000|Participant Flow|Mobile Application Diabetes Doctor|This group was given the opportunity to use the mobile app: Diabetes Doctor to send in blood sugars to communicate with their physician.
11119898|NCT01698008|FG001|Participant Flow|Standard of Care Group|This group continued to communicate with their physician regarding their blood sugars as per standard of care and routine clinic follow ups. No intervention was made.
11119899|NCT01698008|OG000|Outcome|Mobile Application Diabetes Doctor|This group was given the opportunity to use the mobile app Diabetes Doctor to communicate with their physician about their blood sugars.
11119900|NCT01698008|OG001|Outcome|Standard of Care|This group followed standard of care, did not use the mobile app Diabetes Doctor.
11119901|NCT01698008|EG000|Reported Event|Mobile Application Diabetes Doctor|This group used the mobile app Diabetes Doctor to communicate with their physicians about their blood sugars.
11119902|NCT01698008|EG001|Reported Event|Standard of Care|This group did not use the mobile app Diabetes Doctor to communicate with their physicians.
11119903|NCT01698268|BG000|Baseline|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.~TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
11119904|NCT01698268|BG001|Baseline|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.~Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
11119905|NCT01698268|BG002|Baseline|Total|Total of all reporting groups
11119906|NCT01698268|FG000|Participant Flow|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.~TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
11119907|NCT01698268|FG001|Participant Flow|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.~Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
11119908|NCT01698268|OG000|Outcome|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.~TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
11119909|NCT01698268|OG001|Outcome|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.~Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
11119910|NCT01698268|EG000|Reported Event|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.~TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
11119911|NCT01698268|EG001|Reported Event|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.~Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
11119912|NCT01698320|BG000|Baseline|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
11119913|NCT01698320|BG001|Baseline|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
11119914|NCT01698320|BG002|Baseline|Total|Total of all reporting groups
11119915|NCT01698320|FG000|Participant Flow|All Enrolled Subjects|Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.
11119916|NCT01698320|FG001|Participant Flow|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
11119917|NCT01698320|FG002|Participant Flow|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
11119918|NCT01698320|OG000|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
11119919|NCT01698320|OG001|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
11119920|NCT01698320|EG000|Reported Event|Albuterol MDPI - Double-blind Period|Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.
11119921|NCT01698320|EG001|Reported Event|Placebo MDPI - Double-blind Period|Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.
11119922|NCT01698320|EG002|Reported Event|Albuterol MDPI (Formerly Placebo) - Open Label Period|After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
11119923|NCT01698320|EG003|Reported Event|Albuterol MDPI (Formerly Albuterol) - Open Label Period|After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
11119924|NCT01698333|BG000|Baseline|122-0551|122-0551: Applied twice daily for 2 weeks
11119925|NCT01698333|FG000|Participant Flow|122-0551|122-0551: Applied twice daily for 2 weeks
11119926|NCT01698333|OG000|Outcome|122-0551|122-0551: Applied twice daily for 2 weeks
11119927|NCT01698333|EG000|Reported Event|122-0551|122-0551: Applied twice daily for 2 weeks
11119928|NCT01698463|BG000|Baseline|Identify Patients at Risk/Exercise Prescription|"The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.~Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls."
11119929|NCT01698463|FG000|Participant Flow|Identify Patients at Risk/Exercise Prescription|The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist.Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.
11119930|NCT01698463|OG000|Outcome|Identify Patients at Risk/Exercise Prescription|"The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.~Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls."
11119931|NCT01698463|EG000|Reported Event|Identify Patients at Risk/Exercise Prescription|"The intervention was delivered in two visits and two follow-up phone calls. Physician identifies that the patient is at risk of falls or fractures Visit one: individualized exercise prescription by a physiotherapist. Visit two: motivational interviewing (behavioural counselling) by kinesiologist Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.~Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes: The intervention was delivered in two visits and two follow-up phone calls."
11119932|NCT01698502|BG000|Baseline|Trained|Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
11119933|NCT01698502|BG001|Baseline|Untrained|Healthy, sedentary (Maximal oxygen uptake (VO2max), ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
11119934|NCT01698502|BG002|Baseline|Total|Total of all reporting groups
11119935|NCT01698502|FG000|Participant Flow|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
11119936|NCT01698502|FG001|Participant Flow|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
11119937|NCT01698502|OG000|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
11119938|NCT01698502|OG001|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
11119939|NCT01698502|EG000|Reported Event|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
11119940|NCT01698502|EG001|Reported Event|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
11119941|NCT01698528|BG000|Baseline|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
11119942|NCT01698528|BG001|Baseline|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
11119943|NCT01698528|BG002|Baseline|Total|Total of all reporting groups
11119944|NCT01698528|FG000|Participant Flow|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
11119945|NCT01698528|FG001|Participant Flow|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
11119946|NCT01698528|OG000|Outcome|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
11119947|NCT01698528|OG001|Outcome|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
11119948|NCT01698528|EG000|Reported Event|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
11119949|NCT01698528|EG001|Reported Event|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
11119950|NCT01698554|BG000|Baseline|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119951|NCT01698554|BG001|Baseline|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119952|NCT01698554|BG002|Baseline|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119953|NCT01698554|BG003|Baseline|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119954|NCT01698554|BG004|Baseline|Total|Total of all reporting groups
11119955|NCT01698554|FG000|Participant Flow|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119956|NCT01698554|FG001|Participant Flow|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119957|NCT01698554|FG002|Participant Flow|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119958|NCT01698554|FG003|Participant Flow|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119959|NCT01698554|OG000|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119960|NCT01698554|OG001|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119961|NCT01698554|OG002|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119962|NCT01698554|OG003|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119963|NCT01698554|EG000|Reported Event|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119964|NCT01698554|EG001|Reported Event|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119965|NCT01698554|EG002|Reported Event|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119966|NCT01698554|EG003|Reported Event|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
11119967|NCT01698684|BG000|Baseline|Placebo|Placebo: One dose 15 minutes before attempting intercourse
11119968|NCT01698684|BG001|Baseline|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
11119969|NCT01698684|BG002|Baseline|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
11119970|NCT01698684|BG003|Baseline|Total|Total of all reporting groups
11119971|NCT01698684|FG000|Participant Flow|Placebo|Placebo: One dose 15 minutes before attempting intercourse
11119972|NCT01698684|FG001|Participant Flow|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
11119973|NCT01698684|FG002|Participant Flow|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
11119974|NCT01698684|OG000|Outcome|Placebo|Placebo: One dose 15 minutes before attempting intercourse
11119975|NCT01698684|OG001|Outcome|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
11119976|NCT01698684|OG002|Outcome|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
11119977|NCT01698684|EG000|Reported Event|Placebo|Placebo: One dose 15 minutes before attempting intercourse
11119978|NCT01698684|EG001|Reported Event|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
11119979|NCT01698684|EG002|Reported Event|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
11119980|NCT01698710|BG000|Baseline|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
11119981|NCT01698710|FG000|Participant Flow|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
11119982|NCT01698710|OG000|Outcome|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
11119983|NCT01698710|EG000|Reported Event|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
11119984|NCT01698775|BG000|Baseline|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
11005975|NCT01083706|FG000|Participant Flow|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
11005976|NCT01083706|OG000|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
11005977|NCT01083706|EG000|Reported Event|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
11005978|NCT01083732|BG000|Baseline|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005979|NCT01083732|BG001|Baseline|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005980|NCT01083732|BG002|Baseline|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005981|NCT01083732|BG003|Baseline|Total|Total of all reporting groups
11005982|NCT01083732|FG000|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years):|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005983|NCT01083732|FG001|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005984|NCT01083732|FG002|Participant Flow|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005985|NCT01083732|OG000|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005986|NCT01083732|OG001|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005987|NCT01083732|OG002|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005988|NCT01083732|OG000|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005989|NCT01083732|OG001|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005990|NCT01083732|OG000|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation).
11005991|NCT01083732|EG000|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005992|NCT01083732|EG001|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005993|NCT01083732|EG002|Reported Event|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
11005994|NCT01083758|BG000|Baseline|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
11005995|NCT01083758|FG000|Participant Flow|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
11005996|NCT01083758|OG000|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
11119985|NCT01698775|BG001|Baseline|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
11119986|NCT01698775|BG002|Baseline|Total|Total of all reporting groups
11119987|NCT01698775|FG000|Participant Flow|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
11119988|NCT01698775|FG001|Participant Flow|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
11119989|NCT01698775|OG000|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
11119990|NCT01698775|OG001|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
11119991|NCT01698775|OG000|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
11119992|NCT01698775|OG001|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
11119993|NCT01698775|EG000|Reported Event|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
11119994|NCT01698775|EG001|Reported Event|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
11119995|NCT01698775|EG002|Reported Event|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
11119996|NCT01698775|EG003|Reported Event|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
11119997|NCT01698801|BG000|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
11119998|NCT01698801|FG000|Participant Flow|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
11119999|NCT01698801|OG000|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason."
11120000|NCT01698801|OG000|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
11120001|NCT01698801|EG000|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle~Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle"
11120002|NCT01698814|BG000|Baseline|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
11120003|NCT01698814|BG001|Baseline|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
11120004|NCT01698814|BG002|Baseline|Total|Total of all reporting groups
11120005|NCT01698814|FG000|Participant Flow|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
11120006|NCT01698814|FG001|Participant Flow|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
11120007|NCT01698814|OG000|Outcome|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
11120008|NCT01698814|OG001|Outcome|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
11120009|NCT01698814|EG000|Reported Event|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
11120010|NCT01698814|EG001|Reported Event|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
11348391|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing at baseline - the assessment after 1 month."
11005997|NCT01083758|EG000|Reported Event|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
11005998|NCT01083810|BG000|Baseline|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
11005999|NCT01083810|BG001|Baseline|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
11006000|NCT01083810|BG002|Baseline|Non-B|Participants infected with non-B subtypes of HIV-1.
11006001|NCT01083810|BG003|Baseline|Total|Total of all reporting groups
11006002|NCT01083810|FG000|Participant Flow|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
11006003|NCT01083810|FG001|Participant Flow|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
11006004|NCT01083810|FG002|Participant Flow|Non-B|Participants infected with non-B subtypes of HIV-1.
11006005|NCT01083810|OG000|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
11006006|NCT01083810|OG001|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
11006007|NCT01083810|OG002|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
11006008|NCT01083810|EG000|Reported Event|HIV-infected Patients|Participants with HIV-1 infection, pooled from 3 studies in different populations conducted in parallel: KAL1RO (therapy-naive, NCT01083810, n=137), KAL2RO /KAL5RO (pre-treated, NCT01083836, n=92), and KAL6RO (non-B subtype, NCT01081470, n=55).
11006009|NCT01083849|BG000|Baseline|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006010|NCT01083849|BG001|Baseline|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006011|NCT01083849|BG002|Baseline|Total|Total of all reporting groups
11006012|NCT01083849|FG000|Participant Flow|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006013|NCT01083849|FG001|Participant Flow|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006014|NCT01083849|OG000|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006015|NCT01083849|OG000|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006016|NCT01083849|OG001|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006017|NCT01083849|OG000|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006018|NCT01083849|OG001|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006019|NCT01083849|EG000|Reported Event|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006020|NCT01083849|EG001|Reported Event|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
11006021|NCT01083901|BG000|Baseline|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
11006022|NCT01083901|BG001|Baseline|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
11006023|NCT01083901|BG002|Baseline|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
11006024|NCT01083901|BG003|Baseline|Total|Total of all reporting groups
11006025|NCT01083901|FG000|Participant Flow|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
11006026|NCT01083901|FG001|Participant Flow|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
11120011|NCT01698879|BG000|Baseline|Cohort 1, Version 1.0|"Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):~GO: 6 mg/m^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.~If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered."
11120012|NCT01698879|BG001|Baseline|Cohort 1, Version 2.0|"Mylotarg: Cohort 1 (20 evaluable patients):~GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4.~Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120013|NCT01698879|BG002|Baseline|Cohort 2|"Cohort 2 (20 evaluable patients):~G-CSF: 150 mcg/m^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1.~Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO."
11120014|NCT01698879|BG003|Baseline|Total|Total of all reporting groups
11120015|NCT01698879|FG000|Participant Flow|Cohort 1 Version 1.0|"Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):~GO: 6 mg/m^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.~If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered."
11120016|NCT01698879|FG001|Participant Flow|Cohort 1 Version 2.0|"Idarubicin, cytarabine, Mylotarg~Mylotarg: Cohort 1 (20 evaluable patients):~GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120017|NCT01698879|FG002|Participant Flow|Cohort 2|"Cohort 2 (20 evaluable patients):~G-CSF: 150 mcg/m^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1.~Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO."
11120018|NCT01698879|OG000|Outcome|Cohort 1, Version 1.0|"Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):~GO: 6 mg/m^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.~If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered."
11120019|NCT01698879|OG001|Outcome|Cohort 1, Version 2.0|"Mylotarg: Cohort 1 (20 evaluable patients):~GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120020|NCT01698879|OG002|Outcome|Cohort 2|"Cohort 2 (20 evaluable patients):~G-CSF: 150 mcg/m^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1.~Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO."
11120021|NCT01698879|OG000|Outcome|Cohort 1, Version 1.0|Initial 5 patients of cohort 1 (closed due toxicity)
11120022|NCT01698879|OG001|Outcome|Cohort 1, Version 2.0|"Idarubicin, cytarabine, Mylotarg~Mylotarg: Cohort 1 (20 evaluable patients):~GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120023|NCT01698879|OG001|Outcome|Cohort 1 Version 2.0|"Mylotarg: Cohort 1 (20 evaluable patients):~GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120024|NCT01698879|OG000|Outcome|Cohort 1, Version 2.0|"Idarubicin, cytarabine, Mylotarg.~Mylotarg: Cohort 1 (20 evaluable patients):~GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120025|NCT01698879|OG001|Outcome|Cohort 2|"Cohort 2 (20 evaluable patients):~G-CSF: 150 mcg/m^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1.~Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO."
11120026|NCT01698879|OG000|Outcome|Cohort 1|"Idarubicin, cytarabine, Mylotarg, G-CSF.~Mylotarg: Cohort 1 (20 evaluable patients):~GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120027|NCT01698879|EG000|Reported Event|Cohort 1|"Idarubicin, cytarabine, Mylotarg, G-CSF.~Mylotarg: Cohort 1 (20 evaluable patients):~GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120028|NCT01698879|EG001|Reported Event|Cohort 2|"Cohort 2 (20 evaluable patients):~G-CSF: 150 mcg/m^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1.~Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO."
11120029|NCT01698879|EG002|Reported Event|5 Patients Treated in Trial With Prrotocol Version 1.0|"Idarubicin, cytarabine, Mylotarg, G-CSF.~Mylotarg::~GO: 5 mg/m^2 (maximum 10 mg), IV infusion, 2 hours, day 1. If no adequate response, GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1.~Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO."
11120030|NCT01699022|BG000|Baseline|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
11120031|NCT01699022|FG000|Participant Flow|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
11120032|NCT01699022|OG000|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
11120033|NCT01699022|OG000|Outcome|Cyclofem|
11120034|NCT01699022|EG000|Reported Event|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
11120035|NCT01699087|BG000|Baseline|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
11120036|NCT01699087|FG000|Participant Flow|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
11120037|NCT01699087|OG000|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
11120038|NCT01699087|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11120039|NCT01699087|EG001|Reported Event|PRK ALLEGRETTO|All subjects who underwent PRK surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
11120040|NCT01699178|BG000|Baseline|Oral Testosterone Undecanoate|"Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.~Oral testosterone undecanoate: Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID"
11120041|NCT01699178|BG001|Baseline|Transdermal Testosterone Gel (AndroGel)|"Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months~Transdermal testosterone gel (AndroGel): Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD"
11120042|NCT01699178|BG002|Baseline|Total|Total of all reporting groups
11120043|NCT01699178|FG000|Participant Flow|Oral Testosterone Undecanoate|Oral testosterone undecanoate 100-300 mg T BID, for 12 months.
11120044|NCT01699178|FG001|Participant Flow|Transdermal Testosterone Gel (AndroGel)|Transdermal testosterone gel 2.5-10 g/applied once daily for 12 months
11120045|NCT01699178|OG000|Outcome|Oral TU|Subjects treated with Oral TU
11120046|NCT01699178|OG001|Outcome|Transdermal T-gel|Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.
11120047|NCT01699178|EG000|Reported Event|Oral TU|Subjects treated with Oral TU with a measurement taken after approximately 365 days of treatment are used for safety laboratory values for comparisons to baseline. All subjects who received at least one dose of study drug were included in the reporting of treatment emergent adverse events.
11120048|NCT01699178|EG001|Reported Event|Transdermal T-gel|Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment are used for safety laboratory values for comparisons to baseline. All subjects who received at least one dose of study drug were included in the reporting of treatment emergent adverse events.
11120049|NCT01699373|BG000|Baseline|Ultrasound-assisted|Pre-procedural ultrasound scan performed
11120050|NCT01699373|BG001|Baseline|Manual Palpation|
11120051|NCT01699373|BG002|Baseline|Total|Total of all reporting groups
11120052|NCT01699373|FG000|Participant Flow|Ultrasound-assisted|Pre-procedural ultrasound scan performed
11120053|NCT01699373|FG001|Participant Flow|Manual Palpation|
11120054|NCT01699373|OG000|Outcome|Ultrasound-assisted|Pre-procedural ultrasound scan performed
11120055|NCT01699373|OG001|Outcome|Manual Palpation|
11120056|NCT01699373|EG000|Reported Event|Ultrasound-assisted|Pre-procedural ultrasound scan performed
11120057|NCT01699373|EG001|Reported Event|Manual Palpation|
11120058|NCT01699503|BG000|Baseline|Screening Group|"Subjects who are randomized into the screening arm of the study will be screened by the Memory Impairment Screen(MIS). Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.~Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver."
11120059|NCT01699503|BG001|Baseline|No Screening|Subjects who are randomized into the non-screening arm will receive the usual standard of care.
11120060|NCT01699503|BG002|Baseline|Total|Total of all reporting groups
11120061|NCT01699503|FG000|Participant Flow|Screening Group|"Subjects who are randomized into the screening arm of the study will be screened by the Memory Impairment Screen (MIS). Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.~Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver."
11120062|NCT01699503|FG001|Participant Flow|No Screening|Subjects who are randomized into the non-screening arm will receive the usual standard of care.
11120063|NCT01699503|OG000|Outcome|Screening Group|"Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.~Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver."
11120064|NCT01699503|OG001|Outcome|No Screening|Subjects who are randomized into the non-screening arm will receive the usual standard of care.
11120065|NCT01699503|EG000|Reported Event|Screening Group|"Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.~Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver."
11120066|NCT01699503|EG001|Reported Event|No Screening|Subjects who are randomized into the non-screening arm will receive the usual standard of care.
11120067|NCT01699542|BG000|Baseline|Metal Stent|"The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.~WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell"
11120068|NCT01699542|BG001|Baseline|Bougie Dilation|"Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.~Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference"
11120069|NCT01699542|BG002|Baseline|Total|Total of all reporting groups
11120070|NCT01699542|FG000|Participant Flow|Metal Stent|"The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.~WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell"
11120071|NCT01699542|FG001|Participant Flow|Bougie Dilation|"Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.~Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference"
11120072|NCT01699542|OG000|Outcome|Metal Stent|"The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.~WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell"
11120073|NCT01699542|OG001|Outcome|Bougie Dilation|"Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.~Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference"
11120074|NCT01699542|EG000|Reported Event|Metal Stent|"The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.~WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell"
11120075|NCT01699542|EG001|Reported Event|Bougie Dilation|"Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.~Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference"
11120076|NCT01699607|BG000|Baseline|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year.
11120077|NCT01699607|BG001|Baseline|Nonsmoker Subjects|Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year.
11120078|NCT01699607|BG002|Baseline|Total|Total of all reporting groups
11120079|NCT01699607|FG000|Participant Flow|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day for the past year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
11120080|NCT01699607|FG001|Participant Flow|Nonsmoking Subjects|Nonsmokers are subjects who have smoked less than 40 cigarettes in their lifetime, and none within the last year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
11120081|NCT01699607|OG000|Outcome|Smoking Subjects|Cigarette smokers. These are subjects who smoke at least 10 cigarettes per day for the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan.
11120082|NCT01699607|OG001|Outcome|Nonsmoking Subjects|Nonsmokers. These are subjects who smoked less than 40 cigarettes in their lifetime and none in the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan
11120083|NCT01699607|EG000|Reported Event|Amphetamine|"There is only one arm to the study. All subjects will receive amphetamine.~Amphetamine: All subjects will receive amphetamine to induce elevated dopamine levels in the brain."
11120084|NCT01699685|BG000|Baseline|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
11120085|NCT01699685|BG001|Baseline|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
11120086|NCT01699685|BG002|Baseline|Total|Total of all reporting groups
11120087|NCT01699685|FG000|Participant Flow|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
11120088|NCT01699685|FG001|Participant Flow|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
11120089|NCT01699685|OG000|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
11120090|NCT01699685|OG001|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
11120091|NCT01699685|EG000|Reported Event|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
11120092|NCT01699685|EG001|Reported Event|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
11120093|NCT01699698|BG000|Baseline|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
11120094|NCT01699698|BG001|Baseline|Control|Normal cohort
11120095|NCT01699698|BG002|Baseline|Total|Total of all reporting groups
11120096|NCT01699698|FG000|Participant Flow|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
11120097|NCT01699698|FG001|Participant Flow|Control|Normal cohort
11120098|NCT01699698|OG000|Outcome|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
11120099|NCT01699698|OG001|Outcome|Control|Normal cohort
11120100|NCT01699698|OG000|Outcome|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
11120101|NCT01699698|EG000|Reported Event|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
11120102|NCT01699698|EG001|Reported Event|Normal|Normal cohort
11120103|NCT01699750|BG000|Baseline|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
11120104|NCT01699750|BG001|Baseline|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
11120105|NCT01699750|BG002|Baseline|Total|Total of all reporting groups
11120106|NCT01699750|FG000|Participant Flow|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
11120107|NCT01699750|FG001|Participant Flow|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
11120108|NCT01699750|OG000|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
11120109|NCT01699750|OG001|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
11120110|NCT01699750|OG000|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
11120111|NCT01699750|OG001|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
11120112|NCT01699750|OG002|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
11120113|NCT01699750|OG003|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
11120114|NCT01699750|EG000|Reported Event|AIR OPTIX AQUA|Lotrafilcon B contact lenses worn for 60 days, replaced monthly
11120115|NCT01699750|EG001|Reported Event|ACUVUE OASYS With HYDRACLEAR|Senofilcon A contact lenses worn for 60 days, replaced biweekly
11120116|NCT01699763|BG000|Baseline|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
11120117|NCT01699763|FG000|Participant Flow|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
11120118|NCT01699763|OG000|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
11120119|NCT01699763|EG000|Reported Event|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
11120120|NCT01699789|BG000|Baseline|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
11348392|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing at baseline -the assessment after 3 months."
11126839|NCT01736085|BG001|Baseline|Materials Plus Voucher|"Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches~Voucher: Subjects will receive a voucher for nicotine patches.~Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date."
11348393|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|"Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin~SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing at baseline - the assessment after 6 months."
11348394|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing at baseline. The assessment after 6 months."
11006027|NCT01083901|FG002|Participant Flow|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
11006028|NCT01083901|OG000|Outcome|Acetaminophen and Resistance Exercise Training|
11006029|NCT01083901|OG001|Outcome|Ibuprofen and Resistance Exercise Training|
11006030|NCT01083901|OG002|Outcome|Placebo and Resistance Exercise Training|
11006031|NCT01083901|EG000|Reported Event|Acetaminophen and Resistance Exercise Training|
11006032|NCT01083901|EG001|Reported Event|Ibuprofen and Resistance Exercise Traininig|
11006033|NCT01083901|EG002|Reported Event|Placebo and Resistance Exercise Training|
11006034|NCT01083979|BG000|Baseline|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
11006035|NCT01083979|FG000|Participant Flow|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
11006036|NCT01083979|OG000|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
11006037|NCT01083979|EG000|Reported Event|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
11006038|NCT01084005|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
11006039|NCT01084005|BG001|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006040|NCT01084005|BG002|Baseline|Total|Total of all reporting groups
11006041|NCT01084005|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
11006042|NCT01084005|FG001|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006043|NCT01084005|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
11006044|NCT01084005|OG001|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006045|NCT01084005|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
11006046|NCT01084005|EG001|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006047|NCT01084083|BG000|Baseline|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
11006048|NCT01084083|FG000|Participant Flow|Overall|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
11006049|NCT01084083|OG000|Outcome|Primary Study Population|The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
11006050|NCT01084083|OG000|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
11006051|NCT01084083|EG000|Reported Event|All Treated Patients|"Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.~Adverse events data were reported for all patients received at least one dose of protocol therapy."
11006052|NCT01084135|BG000|Baseline|20 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
11006053|NCT01084135|BG001|Baseline|20 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
11006054|NCT01084135|BG002|Baseline|12 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
11006055|NCT01084135|BG003|Baseline|12 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
11006056|NCT01084135|BG004|Baseline|Total|Total of all reporting groups
11120121|NCT01699789|BG001|Baseline|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
11120122|NCT01699789|BG002|Baseline|Total|Total of all reporting groups
11120123|NCT01699789|FG000|Participant Flow|Resources for Services RS|"The RS condition offers time-limited technical assistance to individual agencies, coupled with outreach from a community engagement specialty, to participate in structured reviews of components of the Quality Improvement (QI) Program Intervention as implemented by the RS Expert Team.~QI Program: The quality improvement program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~RS Expert Team: The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. T"
11120124|NCT01699789|FG001|Participant Flow|Community Engagement and Planning CEP|"The CEP arm supported 4 months of planning for the CEP Council consisting of representatives from all assigned programs in biweekly 2 hour meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites were provided with enrolled client lists.~QI Program: The QI program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~CEP Council: The CEP Council was supported by a workbook de"
11120125|NCT01699789|OG000|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
11120126|NCT01699789|OG001|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
11120127|NCT01699789|OG000|Outcome|Resources for Services RS|"The RS condition offers time-limited technical assistance to individual agencies, coupled with outreach from a community engagement specialty, to participate in structured reviews of components of the Quality Improvement (QI) Program Intervention as implemented by the RS Expert Team.~QI Program: The quality improvement program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~RS Expert Team: The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. T"
11120128|NCT01699789|OG001|Outcome|Community Engagement and Planning CEP|"The CEP arm supported 4 months of planning for the CEP Council consisting of representatives from all assigned programs in biweekly 2 hour meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites were provided with enrolled client lists.~QI Program: The QI program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~CEP Council: The CEP Council was supported by a workbook de"
11348395|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin
11348396|NCT04178590|OG001|Outcome|SRP + Placebo|Scaling and root planing in conjunction with saline
11120129|NCT01699789|EG000|Reported Event|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
11120130|NCT01699789|EG001|Reported Event|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
11120131|NCT01699815|BG000|Baseline|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
11120132|NCT01699815|BG001|Baseline|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
11120133|NCT01699815|BG002|Baseline|Total|Total of all reporting groups
11120134|NCT01699815|FG000|Participant Flow|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
11120135|NCT01699815|FG001|Participant Flow|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
11120136|NCT01699815|OG000|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
11120137|NCT01699815|OG001|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
11120138|NCT01699815|EG000|Reported Event|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended for OfirmevTM administration.~Acetaminophen"
11120139|NCT01699815|EG001|Reported Event|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
11120140|NCT01699867|BG000|Baseline|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
11120141|NCT01699867|FG000|Participant Flow|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
11120142|NCT01699867|OG000|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
11120143|NCT01699867|EG000|Reported Event|All Patients (Single-arm)|All enrolled study patients.
11120144|NCT01700036|BG000|Baseline|Treatment Arm|"Alpha-1-Antitrypsin (AAT) for the treatment of Steroid Refractory Acute Graft vs Host Disease.~Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28. A second course of treatment will not be given."
11120145|NCT01700036|FG000|Participant Flow|Treatment Arm|"Alpha-1-Antitrypsin (AAT) for the treatment of Steroid Refractory Acute Graft vs Host Disease.~Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28. A second course of treatment will not be given."
11120146|NCT01700036|OG000|Outcome|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
11120147|NCT01700036|EG000|Reported Event|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
11120148|NCT01700049|BG000|Baseline|Open Label Oral Vismodegib|"This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.~vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24."
11348397|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|"Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin~SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing at baseline - the assessment after 6 months"
11120149|NCT01700049|FG000|Participant Flow|Open Label Oral Vismodegib|"This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma (BCC).~vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24."
11348398|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing at baseline - the assessment after 6 months"
11120150|NCT01700049|OG000|Outcome|Open Label Oral Vismodegib|"This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.~vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24."
11120151|NCT01700049|OG000|Outcome|Open Label Oral Vismodegib|This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma. vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
11120152|NCT01700049|EG000|Reported Event|Open Label Oral Vismodegib|"This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.~vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24."
11120153|NCT01700140|BG000|Baseline|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120154|NCT01700140|BG001|Baseline|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120155|NCT01700140|BG002|Baseline|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120156|NCT01700140|BG003|Baseline|Total|Total of all reporting groups
11120157|NCT01700140|FG000|Participant Flow|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120158|NCT01700140|FG001|Participant Flow|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120159|NCT01700140|FG002|Participant Flow|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120160|NCT01700140|OG000|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120161|NCT01700140|OG001|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120162|NCT01700140|OG002|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120163|NCT01700140|OG000|Outcome|Placebo Patch|"Placebo 15 cm2 patch was applied to subjects in placebo group and low dose group.~Placebo 25 cm2 patch was applied to subjects in placebo group."
11120164|NCT01700140|OG001|Outcome|SyB D-0701 15 cm2 Patch|SyB D-0701 15 cm2 patch (11.25 mg) was applied to subjects in high dose group.
11120165|NCT01700140|OG002|Outcome|SyB D-0701 25 cm2 Patch|SyB D-0701 25 cm2 patch (18.75 mg) was applied to subjects in low dose group and high dose group.
11120166|NCT01700140|EG000|Reported Event|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120167|NCT01700140|EG001|Reported Event|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120168|NCT01700140|EG002|Reported Event|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
11120169|NCT01700179|BG000|Baseline|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
11120170|NCT01700179|FG000|Participant Flow|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per the label) for Days 1-84.~ACH-0143102~Ribavirin"
11120171|NCT01700179|OG000|Outcome|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
11120172|NCT01700179|EG000|Reported Event|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
11120173|NCT01700192|BG000|Baseline|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
11120174|NCT01700192|BG001|Baseline|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
11120175|NCT01700192|BG002|Baseline|Total|Total of all reporting groups
11120176|NCT01700192|FG000|Participant Flow|MK-8237|Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.
11120177|NCT01700192|FG001|Participant Flow|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
11120178|NCT01700192|OG000|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
11120179|NCT01700192|OG001|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
11120180|NCT01700192|EG000|Reported Event|MK-8237 12 DU|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
11120181|NCT01700192|EG001|Reported Event|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
11120182|NCT01700205|BG000|Baseline|Type of Formula: CMF|"infant is randomized to feed standard cow milk infant formula [CMF] during first year of life~Type of Formula: infant formula"
11120183|NCT01700205|BG001|Baseline|Type of Formula: EHF|"infant is randomized to feed extensively hydrolyzed protein infant formula [EHF] first year of life~Type of Formula: infant formula"
11120184|NCT01700205|BG002|Baseline|Total|Total of all reporting groups
11120185|NCT01700205|FG000|Participant Flow|Type of Formula: CMF|"infant is randomized to feed standard cow milk formula during first year of life~Type of Formula: infant formula"
11120186|NCT01700205|FG001|Participant Flow|Type of Formula: EHF|"infant is randomized to feed extensively hydrolyzed infant formula during first year of life~Type of Formula: infant formula"
11120187|NCT01700205|OG000|Outcome|Type of Formula: CMF|"Infant is randomized to be fed standard cow milk formula during first year of life~Type of Formula: CMF"
11120188|NCT01700205|OG001|Outcome|Type of Formula: EHF|"Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life~Type of Formula: EHF"
11120189|NCT01700205|EG000|Reported Event|Type of Formula: CMF|"infant is randomized to feed standard cow milk formula during first year of life~Type of Formula: infant formula"
11120190|NCT01700205|EG001|Reported Event|Type of Formula: EHF|"infant is randomized to feed extensively hydrolyzed infant formula during first year of life~Type of Formula: infant formula"
11120191|NCT01700335|BG000|Baseline|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
11120192|NCT01700335|FG000|Participant Flow|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
11120193|NCT01700335|FG001|Participant Flow|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
11120194|NCT01700335|OG000|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
11120195|NCT01700335|OG001|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
11120196|NCT01700335|OG000|Outcome|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
11120197|NCT01700335|EG000|Reported Event|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
11120198|NCT01700335|EG001|Reported Event|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
11120199|NCT01700387|BG000|Baseline|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120200|NCT01700387|BG001|Baseline|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120201|NCT01700387|BG002|Baseline|Total|Total of all reporting groups
11348399|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|"Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin~SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing at baseline - the assessment after 1 month"
11348400|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing at baseline - the assessment after 1 month"
11120202|NCT01700387|FG000|Participant Flow|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs (every night at bedtime) Week 2: topiramate 25 mg bid (twice a day) Week 3: topiramate 25 mg q am (every day before noon) + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120203|NCT01700387|FG001|Participant Flow|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs (every night at bedtime) Week 2: 1 tab bid (twice daily) Week 3: 1 tab q am (every day before noon) + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120204|NCT01700387|OG000|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120205|NCT01700387|OG001|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120206|NCT01700387|OG000|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120207|NCT01700387|OG001|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120208|NCT01700387|OG000|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.~Topiramate: Subjects randomized to the onabotulinumtoxinA + topiramate group will receive:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate"
11120209|NCT01700387|OG001|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.~Placebo: Subjects randomized to the onabotulinumtoxinA + placebo group will receive:~Week 1: placebo 25 mg qhs Week 2: placebo 25 mg bid Week 3: placebo 25 mg q am + placebo 50 mg qhs Week 4: placebo 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period."
11120210|NCT01700387|EG000|Reported Event|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120211|NCT01700387|EG001|Reported Event|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
11120212|NCT01700517|BG000|Baseline|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
11120213|NCT01700517|BG001|Baseline|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
11120214|NCT01700517|BG002|Baseline|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
11120215|NCT01700517|BG003|Baseline|Total|Total of all reporting groups
11120216|NCT01700517|FG000|Participant Flow|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
11120217|NCT01700517|FG001|Participant Flow|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
11120218|NCT01700517|FG002|Participant Flow|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
11120219|NCT01700517|OG000|Outcome|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
11120220|NCT01700517|OG001|Outcome|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
11120221|NCT01700517|OG002|Outcome|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
11348401|NCT04178590|OG000|Outcome|SRP + Injectable Platelet-Rich Fibrin|"Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin~SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing"
11120222|NCT01700517|EG000|Reported Event|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
11120223|NCT01700517|EG001|Reported Event|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
11348402|NCT04178590|OG001|Outcome|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline application during scaling and root planing"
11006057|NCT01084135|FG000|Participant Flow|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
11006058|NCT01084135|FG001|Participant Flow|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
11006059|NCT01084135|OG000|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
11006060|NCT01084135|OG001|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
11006061|NCT01084135|EG000|Reported Event|20 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
11006062|NCT01084135|EG001|Reported Event|20 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
11006063|NCT01084135|EG002|Reported Event|12 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
11006064|NCT01084135|EG003|Reported Event|12 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
11006065|NCT01084148|BG000|Baseline|V0034CR01B|"cream~V0034CR01B"
11006066|NCT01084148|BG001|Baseline|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
11006067|NCT01084148|BG002|Baseline|Total|Total of all reporting groups
11006068|NCT01084148|FG000|Participant Flow|V0034CR01B|"cream~V0034CR01B"
11006069|NCT01084148|FG001|Participant Flow|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
11006070|NCT01084148|OG000|Outcome|V0034CR01B|"cream~V0034CR01B"
11006071|NCT01084148|OG001|Outcome|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
11006072|NCT01084148|OG000|Outcome|V0034CR01B|"cream~V0034CR01B for 28 days (Period I), then treatment free-follow-up (up for 21 days if non persisting lesion and non relapsing lesions (Period II)), then V0034CR01B for 84 days (Period III)"
11006073|NCT01084148|OG001|Outcome|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle for 28 days (Period I), then treatment free-follow-up (up for 21 days if non persisting lesion and non relapsing lesions (Period II)), then V0034CR01B for 84 days (Period III)"
11006074|NCT01084148|EG000|Reported Event|V0034CR01B|"cream~V0034CR01B"
11006075|NCT01084148|EG001|Reported Event|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
11006076|NCT01084174|BG000|Baseline|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
11006077|NCT01084174|BG001|Baseline|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
11006078|NCT01084174|BG002|Baseline|Total|Total of all reporting groups
11006079|NCT01084174|FG000|Participant Flow|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
11006080|NCT01084174|FG001|Participant Flow|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
11006081|NCT01084174|OG000|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
11006082|NCT01084174|OG001|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
11006083|NCT01084174|EG000|Reported Event|Active SLIT/Placebo OIT|Adverse event information is based on percentages of doses. There were 4578 total doses in the Active SLIT/Placebo OIT treatment arm
11006084|NCT01084174|EG001|Reported Event|Active OIT/Placebo SLIT|Adverse event information is based on percentages of doses. There were 4049 total doses in the Active OIT/Placebo SLIT treatment arm
11348403|NCT04178590|EG000|Reported Event|SRP + Injectable Platelet-Rich Fibrin|"Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin~SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing"
11348404|NCT04178590|EG001|Reported Event|SRP + Placebo|"Scaling and root planing in conjunction with saline~SRP + placebo: Saline as adjunct to scaling and root planing"
11348405|NCT04177862|BG000|Baseline|Sublingual Sufentanil|"Single dose of sublingual sufentanil for acute pain.~Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet"
11348406|NCT04177862|BG001|Baseline|IV Fentanyl|"single dose of IV fentanyl for acute pain.~IV Fentanyl: 50 mcg of IV fentanyl"
11348407|NCT04177862|BG002|Baseline|Total|Total of all reporting groups
11006085|NCT01084239|BG000|Baseline|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
11006086|NCT01084239|BG001|Baseline|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
11006087|NCT01084239|BG002|Baseline|Total|Total of all reporting groups
11006088|NCT01084239|FG000|Participant Flow|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
11006089|NCT01084239|FG001|Participant Flow|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
11006090|NCT01084239|OG000|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
11006091|NCT01084239|OG001|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
11006092|NCT01084239|OG000|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
11006093|NCT01084239|OG001|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
11006094|NCT01084239|EG000|Reported Event|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
11006095|NCT01084239|EG001|Reported Event|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
11006096|NCT01084265|BG000|Baseline|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
11006097|NCT01084265|FG000|Participant Flow|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
11006098|NCT01084265|OG000|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
11006099|NCT01084265|EG000|Reported Event|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
11007962|NCT01093885|OG000|Outcome|Open Label: Medication Ambrisentan|"Open label study of Ambrisentan.~Ambrisentan will begin at 5mg daily for the first month.~Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week. Subjects will continue their present dose and schedule of disease modifying/antifibrotic medication for the duration of the study.~Ambrisentan: Drug is dispensed in tablet form. Ambrisentan with anti-fibrotic to assess benefit on skin~Dosing of ambrisentan will begin at 5mg daily for the first month. Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week."
11006100|NCT01084278|BG000|Baseline|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006101|NCT01084278|BG001|Baseline|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006102|NCT01084278|BG002|Baseline|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006103|NCT01084278|BG003|Baseline|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006104|NCT01084278|BG004|Baseline|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
11006105|NCT01084278|BG005|Baseline|Total|Total of all reporting groups
11006106|NCT01084278|FG000|Participant Flow|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006107|NCT01084278|FG001|Participant Flow|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006108|NCT01084278|FG002|Participant Flow|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006109|NCT01084278|FG003|Participant Flow|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006110|NCT01084278|FG004|Participant Flow|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
11006111|NCT01084278|OG000|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
11006112|NCT01084278|OG001|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
11006113|NCT01084278|OG002|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
11006114|NCT01084278|OG003|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
11006115|NCT01084278|OG004|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
11006116|NCT01084278|OG005|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
11006117|NCT01084278|OG000|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
11006118|NCT01084278|EG000|Reported Event|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006119|NCT01084278|EG001|Reported Event|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006120|NCT01084278|EG002|Reported Event|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006121|NCT01084278|EG003|Reported Event|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
11006122|NCT01084278|EG004|Reported Event|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
11006123|NCT01084499|BG000|Baseline|Femara First, Then Peratra (Sequence 1)|Participants first received a branded letrozole (reference - Femara), then a generic letrozole (test - Peratra). Each treatment period was separated by a 5-week washout period.
11006124|NCT01084499|BG001|Baseline|Peratra First, Then Femara (Sequence 2)|Participants first received a generic letrozole (test - Peratra), then a branded letrozole (reference - Femara). Each treatment period was separated by a 5-week washout period.
11006125|NCT01084499|BG002|Baseline|Total|Total of all reporting groups
11006126|NCT01084499|FG000|Participant Flow|Femara First, Then Peratra (Sequence 1)|Participants first received a branded letrozole (reference - Femara), then a generic letrozole (test - Peratra). Each treatment period was separated by a 5-week washout period.
11348408|NCT04177862|FG000|Participant Flow|Sublingual Sufentanil|"Single dose of sublingual sufentanil for acute pain.~Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet"
11006127|NCT01084499|FG001|Participant Flow|Peratra First, Then Femara (Sequence 2)|Participants first received a generic letrozole (test - Peratra), then branded letrozole (reference - Femara). Each treatment period was separated by a 5-week washout period.
11006128|NCT01084499|OG000|Outcome|Peratra|The group of participants who were administered Peratra.
11006129|NCT01084499|OG001|Outcome|Femara|The group of participants who were administered Femara.
11006130|NCT01084499|EG000|Reported Event|Peratra|The group of participants who were administered Peratra.
11006131|NCT01084499|EG001|Reported Event|Femara|The group of participants who were administered Femara.
11006132|NCT01084538|BG000|Baseline|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
11006133|NCT01084538|FG000|Participant Flow|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
11120224|NCT01700517|EG002|Reported Event|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
11120225|NCT01700530|BG000|Baseline|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
11120226|NCT01700530|BG001|Baseline|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
11120227|NCT01700530|BG002|Baseline|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
11120228|NCT01700530|BG003|Baseline|Total|Total of all reporting groups
11120229|NCT01700530|FG000|Participant Flow|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
11120230|NCT01700530|FG001|Participant Flow|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
11120231|NCT01700530|FG002|Participant Flow|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
11120232|NCT01700530|OG000|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
11120233|NCT01700530|OG001|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
11120234|NCT01700530|OG002|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
11120235|NCT01700530|EG000|Reported Event|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
11120236|NCT01700530|EG001|Reported Event|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
11120237|NCT01700530|EG002|Reported Event|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
11120238|NCT01700621|BG000|Baseline|Measles-rubella and Rotavirus Vaccines|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age~Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120239|NCT01700621|BG001|Baseline|Measles-rubella Vaccine|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120240|NCT01700621|BG002|Baseline|Total|Total of all reporting groups
11120241|NCT01700621|FG000|Participant Flow|Measles-rubella and Rotavirus Vaccines|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age~Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120242|NCT01700621|FG001|Participant Flow|Measles-rubella Vaccine|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120243|NCT01700621|OG000|Outcome|Measles-rubella and Rotavirus Vaccines|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age~Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120244|NCT01700621|OG001|Outcome|Measles-rubella Vaccine|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120245|NCT01700621|OG000|Outcome|Measles-rubella and Rotavirus Vaccine|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age~Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120246|NCT01700621|EG000|Reported Event|Measles-rubella and Rotavirus Vaccines|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age~Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120247|NCT01700621|EG001|Reported Event|Measles-rubella Vaccine|"receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age~measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine"
11120248|NCT01700725|BG000|Baseline|Nasal Irrigation - Xylitol|Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
11120249|NCT01700725|BG001|Baseline|Nasal Irrigation - Saline|Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
11120250|NCT01700725|BG002|Baseline|Control Group|Control group subjects continue to use routine care only
11120251|NCT01700725|BG003|Baseline|Total|Total of all reporting groups
11120252|NCT01700725|FG000|Participant Flow|Nasal Irrigation - Xylitol|Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
11120253|NCT01700725|FG001|Participant Flow|Nasal Irrigation - Saline|Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
11120254|NCT01700725|FG002|Participant Flow|Control Group|Control group subjects continue to use routine care only
11348409|NCT04177862|FG001|Participant Flow|IV Fentanyl|"single dose of IV fentanyl for acute pain.~IV Fentanyl: 50 mcg of IV fentanyl"
11120255|NCT01700725|OG000|Outcome|Nasal Irrigation - Xylitol|Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
11120256|NCT01700725|OG001|Outcome|Nasal Irrigation - Saline|Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
11120257|NCT01700725|OG002|Outcome|Control Group|Control group subjects continue to use routine care only
11120258|NCT01700725|EG000|Reported Event|Nasal Irrigation - Xylitol|Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
11120259|NCT01700725|EG001|Reported Event|Nasal Irrigation - Saline|Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
11120260|NCT01700725|EG002|Reported Event|Control Group|Control group subjects continue to use routine care only
11120261|NCT01700816|BG000|Baseline|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
11120262|NCT01700816|BG001|Baseline|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
11120263|NCT01700816|BG002|Baseline|Total|Total of all reporting groups
11120264|NCT01700816|FG000|Participant Flow|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
11120265|NCT01700816|FG001|Participant Flow|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
11120266|NCT01700816|OG000|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
11120267|NCT01700816|OG001|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
11120268|NCT01700816|EG000|Reported Event|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
11120269|NCT01700816|EG001|Reported Event|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
11120270|NCT01700829|BG000|Baseline|Midazolam|"0.02 mg/kg, I.V. (in the vein)~Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes"
11120271|NCT01700829|BG001|Baseline|Ketamine|"0.5 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes"
11120272|NCT01700829|BG002|Baseline|Total|Total of all reporting groups
11120273|NCT01700829|FG000|Participant Flow|Midazolam|"0.02 mg/kg, I.V. (in the vein)~Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes"
11120274|NCT01700829|FG001|Participant Flow|Ketamine|"0.5 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes"
11120275|NCT01700829|OG000|Outcome|Midazolam|Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
11120276|NCT01700829|OG001|Outcome|Ketamine|Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
11120277|NCT01700829|EG000|Reported Event|Midazolam|"0.02 mg/kg, I.V. (in the vein)~Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes"
11120278|NCT01700829|EG001|Reported Event|Ketamine|"0.5 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes"
11120279|NCT01700907|BG000|Baseline|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
11120280|NCT01700907|BG001|Baseline|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
11120281|NCT01700907|BG002|Baseline|Total|Total of all reporting groups
11120282|NCT01700907|FG000|Participant Flow|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
11120283|NCT01700907|FG001|Participant Flow|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
11120284|NCT01700907|OG000|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
11120285|NCT01700907|OG001|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
11120286|NCT01700907|EG000|Reported Event|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
11120287|NCT01700907|EG001|Reported Event|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
11120288|NCT01700959|BG000|Baseline|Melatonin: NI Without DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120289|NCT01700959|BG001|Baseline|Placebo: NI Without DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120290|NCT01700959|BG002|Baseline|Melatonin: NI With DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120291|NCT01700959|BG003|Baseline|Placebo: NI With DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120292|NCT01700959|BG004|Baseline|Melatonin: No NI With DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120293|NCT01700959|BG005|Baseline|Placebo: No NI With DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120294|NCT01700959|BG006|Baseline|Total|Total of all reporting groups
11120295|NCT01700959|FG000|Participant Flow|Melatonin: NI Without DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120296|NCT01700959|FG001|Participant Flow|Placebo: NI Without DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120297|NCT01700959|FG002|Participant Flow|Melatonin: NI With DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120298|NCT01700959|FG003|Participant Flow|Placebo: NI With DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120299|NCT01700959|FG004|Participant Flow|Melatonin: No NI With DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120300|NCT01700959|FG005|Participant Flow|Placebo: No NI With DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120301|NCT01700959|OG000|Outcome|Melatonin: NI Without DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120302|NCT01700959|OG001|Outcome|Placebo: NI Without DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120303|NCT01700959|OG002|Outcome|Melatonin: NI With DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120304|NCT01700959|OG003|Outcome|Placebo: NI With DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120305|NCT01700959|OG004|Outcome|Melatonin: No NI With DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120306|NCT01700959|OG005|Outcome|Placebo: No NI With DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120307|NCT01700959|OG000|Outcome|Melatonin: NI With DSOL (Actigraphy)|"Data by participant actigraphy. Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120308|NCT01700959|OG001|Outcome|Melatonin: NI With DSOL (Self-report)|"Data by participant self-report. Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120309|NCT01700959|EG000|Reported Event|Melatonin: NI Without DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120310|NCT01700959|EG001|Reported Event|Placebo: NI Without DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120311|NCT01700959|EG002|Reported Event|Melatonin: NI With DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120312|NCT01700959|EG003|Reported Event|Placebo: NI With DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11120313|NCT01700959|EG004|Reported Event|Melatonin: No NI With DSOL|"Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.~melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night."
11120314|NCT01700959|EG005|Reported Event|Placebo: No NI With DSOL|"Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.~placebo: Placebo tablets to match the melatonin will be comprised of inert substances."
11126840|NCT01736085|BG002|Baseline|Materials Plus Patches|"Subjects will receive self-help materials and a 2 week's worth of nicotine patches~Nicotine patches: Subjects will receive nicotine patches directly sent to their home.~Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date."
11126841|NCT01736085|BG003|Baseline|Counseling|"Subjects will receive up to 5 sessions of telephone counseling~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling"
11126842|NCT01736085|BG004|Baseline|Counseling Plus Voucher|"Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling~Voucher: Subjects will receive a voucher for nicotine patches.~Subjects ra"
11126843|NCT01736085|BG005|Baseline|Counseling Plus Patches|"Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling~Nicotine patches: Subjects will receive nicotine patches directly sent to their home.~Subj"
11126844|NCT01736085|BG006|Baseline|Total|Total of all reporting groups
11126845|NCT01736085|FG000|Participant Flow|Material Group|Subjects will receive self-help materials
11126846|NCT01736085|FG001|Participant Flow|Materials Plus Voucher|"Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches~Voucher: Subjects will receive a voucher for nicotine patches.~Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date."
11126847|NCT01736085|FG002|Participant Flow|Materials Plus Patches|"Subjects will receive self-help materials and a 2 week's worth of nicotine patches~Nicotine patches: Subjects will receive nicotine patches directly sent to their home.~Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date."
11126848|NCT01736085|FG003|Participant Flow|Counseling|"Subjects will receive up to 5 sessions of telephone counseling~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling"
11224441|NCT02360124|EG000|Reported Event|Control|"instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
11348410|NCT04177862|OG000|Outcome|Sublingual Sufentanil|"Single dose of sublingual sufentanil for acute pain.~Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet"
11120315|NCT01700985|BG000|Baseline|122-0551|122-0551: Applied twice daily for two weeks
11120316|NCT01700985|BG001|Baseline|Vehicle|Vehicle: Applied twice daily for two weeks
11120317|NCT01700985|BG002|Baseline|Total|Total of all reporting groups
11120318|NCT01700985|FG000|Participant Flow|122-0551|122-0551: Applied twice daily for two weeks
11120319|NCT01700985|FG001|Participant Flow|Vehicle|Vehicle: Applied twice daily for two weeks
11120320|NCT01700985|OG000|Outcome|122-0551|122-0551: Applied twice daily for two weeks
11120321|NCT01700985|OG001|Outcome|Vehicle|Vehicle: Applied twice daily for two weeks
11120322|NCT01700985|EG000|Reported Event|122-0551|122-0551: Applied twice daily for two weeks
11120323|NCT01700985|EG001|Reported Event|Vehicle|Vehicle: Applied twice daily for two weeks
11120324|NCT01701011|BG000|Baseline|PRCI-monitoring Group|"Coping intervention, Daily Record Keeping, Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
11120325|NCT01701011|BG001|Baseline|Monitoring-control Group|"DRK and Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
11120326|NCT01701011|BG002|Baseline|Routine Care Control Group|"Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
11120327|NCT01701011|BG003|Baseline|Total|Total of all reporting groups
11120328|NCT01701011|FG000|Participant Flow|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
11120329|NCT01701011|FG001|Participant Flow|Monitoring-control Group|Daily Record Keeping and Questionnaires
11120330|NCT01701011|FG002|Participant Flow|Routine Care Control Group|Patients receive only questionnaires
11120331|NCT01701011|OG000|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
11120332|NCT01701011|OG001|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
11120333|NCT01701011|OG002|Outcome|Routine Care Control Group|patients receive questionnaires
11120334|NCT01701011|OG002|Outcome|Routine Care Control Group|Patients receive only questionnaires
11120335|NCT01701011|EG000|Reported Event|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
11120336|NCT01701011|EG001|Reported Event|Monitoring-control Group|Daily Record Keeping and Questionnaires
11120337|NCT01701011|EG002|Reported Event|Routine Care Control Group|patients received questionnaires
11120338|NCT01701024|BG000|Baseline|ACYC|ACYC active, topically applied to the face for 12 weeks
11120339|NCT01701024|BG001|Baseline|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
11120340|NCT01701024|BG002|Baseline|Total|Total of all reporting groups
11120341|NCT01701024|FG000|Participant Flow|ACYC|ACYC active, topically applied to the face for 12 weeks
11120342|NCT01701024|FG001|Participant Flow|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
11120343|NCT01701024|OG000|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
11120344|NCT01701024|OG001|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
11120345|NCT01701024|EG000|Reported Event|ACYC|ACYC active, topically applied to the face for 12 weeks
11120346|NCT01701024|EG001|Reported Event|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
11120347|NCT01701037|BG000|Baseline|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
11120348|NCT01701037|FG000|Participant Flow|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
11120349|NCT01701037|OG000|Outcome|Dabrafenib and Trametinib|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
11120350|NCT01701037|OG000|Outcome|Dabrafenib and Trametinib|
11120351|NCT01701037|EG000|Reported Event|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
11120352|NCT01701063|BG000|Baseline|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120353|NCT01701063|BG001|Baseline|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120354|NCT01701063|BG002|Baseline|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120355|NCT01701063|BG003|Baseline|Total|Total of all reporting groups
11120356|NCT01701063|FG000|Participant Flow|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram [mg/kg] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved extended rapid virologic response (eRVR) or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.
11120357|NCT01701063|FG001|Participant Flow|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120358|NCT01701063|FG002|Participant Flow|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120359|NCT01701063|OG000|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120360|NCT01701063|OG001|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120361|NCT01701063|OG002|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120362|NCT01701063|OG000|Outcome|Overall Participants|Participants aged 3 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 to 18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120363|NCT01701063|EG000|Reported Event|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120364|NCT01701063|EG001|Reported Event|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120365|NCT01701063|EG002|Reported Event|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
11120366|NCT01701102|BG000|Baseline|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120367|NCT01701102|BG001|Baseline|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120368|NCT01701102|BG002|Baseline|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120369|NCT01701102|BG003|Baseline|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11348411|NCT04177862|OG001|Outcome|IV Fentanyl|"single dose of IV fentanyl for acute pain.~IV Fentanyl: 50 mcg of IV fentanyl"
11348412|NCT04177862|OG000|Outcome|Sublingual Sufentanil|"Single dose of sublingual sufentanil for acute pain.~Sublingual Sufentanil: 30 mcg of sublingual sufentanil"
11120370|NCT01701102|BG004|Baseline|Total|Total of all reporting groups
11120371|NCT01701102|FG000|Participant Flow|Mepivacaine 37.5 mg|Mepivacaine (37.5 mg)
11120372|NCT01701102|FG001|Participant Flow|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)
11120373|NCT01701102|FG002|Participant Flow|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)
11120374|NCT01701102|FG003|Participant Flow|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)
11120375|NCT01701102|OG000|Outcome|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120376|NCT01701102|OG001|Outcome|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120377|NCT01701102|OG002|Outcome|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120378|NCT01701102|OG003|Outcome|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120379|NCT01701102|EG000|Reported Event|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120380|NCT01701102|EG001|Reported Event|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120381|NCT01701102|EG002|Reported Event|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11120382|NCT01701102|EG003|Reported Event|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
11348413|NCT04177862|EG000|Reported Event|Sublingual Sufentanil|"Single dose of sublingual sufentanil for acute pain.~Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet"
11120383|NCT01701115|BG000|Baseline|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
11120384|NCT01701115|BG001|Baseline|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
11120385|NCT01701115|BG002|Baseline|Total|Total of all reporting groups
11120386|NCT01701115|FG000|Participant Flow|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
11120387|NCT01701115|FG001|Participant Flow|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
11120388|NCT01701115|OG000|Outcome|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
11120389|NCT01701115|OG001|Outcome|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
11120390|NCT01701115|EG000|Reported Event|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
11120391|NCT01701115|EG001|Reported Event|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
11120392|NCT01701193|BG000|Baseline|L-Alanyl/L-Glutamine- Laparoscopic|"Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy.~L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements."
11120393|NCT01701193|BG001|Baseline|Physiological Saline- Laparoscopic|"Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy.~Physiologic saline: Placebo"
11120394|NCT01701193|BG002|Baseline|L-Alanyl/L-Glutamine- Laparotomy|"Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy).~L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements."
11120395|NCT01701193|BG003|Baseline|Physiological Saline- Laparotomy|"Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy).~Physiologic saline: Placebo"
11120396|NCT01701193|BG004|Baseline|Total|Total of all reporting groups
11120397|NCT01701193|FG000|Participant Flow|L-Alanyl/L-Glutamine- Laparoscopic|"Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy.~L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements."
11120398|NCT01701193|FG001|Participant Flow|Physiological Saline- Laparoscopic|"Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy.~Physiologic saline: Placebo"
11120399|NCT01701193|FG002|Participant Flow|L-Alanyl/L-Glutamine- Laparotomy|Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy).
11120400|NCT01701193|FG003|Participant Flow|Physiological Saline- Laparotomy|Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy).
11120401|NCT01701193|OG000|Outcome|L-Alanyl/L-Glutamine- Laparoscopic|"Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy.~L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements."
11120402|NCT01701193|OG001|Outcome|Physiological Saline- Laparoscopic|"Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy.~Physiologic saline: Placebo"
11120403|NCT01701193|OG002|Outcome|L-Alanyl/L-Glutamine- Laparotomy|"Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy).~L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements."
11120404|NCT01701193|OG003|Outcome|Physiological Saline- Laparotomy|"Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy).~Physiologic saline: Placebo"
11120405|NCT01701193|OG000|Outcome|L-Alanyl/L-Glutamine|"Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy.~L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements."
11120406|NCT01701193|OG001|Outcome|Physiological Saline|"Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy.~Physiologic saline: Placebo"
11120407|NCT01701193|OG003|Outcome|Physiological Saline- Laparotomy|"Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy)~Physiologic saline: Placebo"
11120408|NCT01701193|EG000|Reported Event|L-Alanyl/L-Glutamine- Laparoscopic|"Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy.~L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements."
11120409|NCT01701193|EG001|Reported Event|Physiological Saline- Laparoscopic|"Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy.~Physiologic saline: Placebo"
11120410|NCT01701193|EG002|Reported Event|L-Alanyl/L-Glutamine- Laparotomy|"Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy).~L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements."
11120411|NCT01701193|EG003|Reported Event|Physiological Saline -Laparotomy|"Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy).~Physiologic saline: Placebo"
11348414|NCT04177862|EG001|Reported Event|IV Fentanyl|"single dose of IV fentanyl for acute pain.~IV Fentanyl: 50 mcg of IV fentanyl"
11120412|NCT01701245|BG000|Baseline|Standard of Care|No intervention, standard of care
11120413|NCT01701245|BG001|Baseline|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
11120414|NCT01701245|BG002|Baseline|Total|Total of all reporting groups
11120415|NCT01701245|FG000|Participant Flow|Standard of Care|No intervention, standard of care
11120416|NCT01701245|FG001|Participant Flow|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
11120417|NCT01701245|OG000|Outcome|Standard of Care|No intervention, standard of care
11120418|NCT01701245|OG001|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
11120419|NCT01701245|EG000|Reported Event|Standard of Care|No intervention, standard of care
11120420|NCT01701245|EG001|Reported Event|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
11120421|NCT01701258|BG000|Baseline|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
11120422|NCT01701258|BG001|Baseline|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
11120423|NCT01701258|BG002|Baseline|CSA/RES Group|"Subjects with a history of CSA but no psychopathology (resilient group; CSA/RES)."
11120424|NCT01701258|BG003|Baseline|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
11120425|NCT01701258|BG004|Baseline|Total|Total of all reporting groups
11120426|NCT01701258|FG000|Participant Flow|All Participants|All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.
11120427|NCT01701258|FG001|Participant Flow|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
11120428|NCT01701258|FG002|Participant Flow|Control-amisulpride (fMRI Session)|After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
11120429|NCT01701258|FG003|Participant Flow|Control-placebo (fMRI Session)|After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
11120430|NCT01701258|FG004|Participant Flow|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode .
11120431|NCT01701258|FG005|Participant Flow|MDD-amisulpride (fMRI Session)|After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
11120432|NCT01701258|FG006|Participant Flow|MDD-placebo (fMRI Session)|After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
11120433|NCT01701258|FG007|Participant Flow|CSA/RES|"Subjects with a history of CSA but no psychopathology (resilient group; CSA/RES)."
11120434|NCT01701258|FG008|Participant Flow|CSA/RES-amisulpride (fMRI Session)|"After the screening visit, eligible subjects with a history of CSA but no psychopathology (resilient group; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session."
11120435|NCT01701258|FG009|Participant Flow|CSA/RES-placebo (fMRI Session)|"After the screening visit, eligible subjects with a history of CSA but no psychopathology (resilient group; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session."
11120436|NCT01701258|FG010|Participant Flow|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA).
11120437|NCT01701258|FG011|Participant Flow|CSA/MDD-amisulpride (fMRI Session)|After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.
11120438|NCT01701258|FG012|Participant Flow|CSA/MDD-placebo (fMRI Session)|"After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.~Many eligible CSA/MDD baseline participants did not complete this session."
11120439|NCT01701258|OG000|Outcome|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
11120440|NCT01701258|OG001|Outcome|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
11120441|NCT01701258|OG002|Outcome|CSA/RES Group|"Subjects with a history of CSA but no psychopathology (resilient group; CSA/RES)."
11120442|NCT01701258|OG003|Outcome|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
11120443|NCT01701258|OG000|Outcome|CSA/MDD-amisulpride|"Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
11120444|NCT01701258|OG001|Outcome|CSA/MDD-placebo|"Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
11120445|NCT01701258|OG002|Outcome|CSA/RES-amisulpride|"Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
11120446|NCT01701258|OG003|Outcome|CSA/RES-placebo|"Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
11120447|NCT01701258|OG004|Outcome|MDD-amisulpride|"Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
11120448|NCT01701258|OG005|Outcome|MDD-placebo|"Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
11120449|NCT01701258|OG006|Outcome|Control-amisulpride|"Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
11120450|NCT01701258|OG007|Outcome|Control-placebo|"Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
11120451|NCT01701258|EG000|Reported Event|All Participants|All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.
11120452|NCT01701258|EG001|Reported Event|All Baseline Participants|Participants that were eligible for the study after the screening visit (session 1). These participants were invited to participate in the other study sessions.
11120453|NCT01701258|EG002|Reported Event|Control Group|Control subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
11120454|NCT01701258|EG003|Reported Event|Control-amisulpride (fMRI Session)|After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
11120455|NCT01701258|EG004|Reported Event|Control-placebo (fMRI Session)|After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
11120456|NCT01701258|EG005|Reported Event|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
11120457|NCT01701258|EG006|Reported Event|MDD-amisulpride (fMRI Session)|After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
10878696|NCT00453986|FG004|Participant Flow|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
10878697|NCT00453986|OG000|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
10878698|NCT00453986|OG001|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
10878699|NCT00453986|OG002|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
10878700|NCT00453986|OG000|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
10878701|NCT00453986|OG001|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of Fluarix vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
10878702|NCT00453986|OG000|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
10878703|NCT00453986|OG001|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
10878704|NCT00453986|OG002|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
10878705|NCT00453986|OG000|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
10878706|NCT00453986|OG001|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
10878707|NCT00453986|OG001|Outcome|Nimenrix (Flu Cohort) Group|Group Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
10878708|NCT00453986|EG000|Reported Event|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
11120458|NCT01701258|EG007|Reported Event|MDD-placebo (fMRI Session)|After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
11120459|NCT01701258|EG008|Reported Event|CSA/RES|"Subjects with a history of CSA but no psychopathology (resilient group; CSA/RES). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions."
11120460|NCT01701258|EG009|Reported Event|CSA/RES-amisulpride (fMRI Session)|"After the screening visit, eligible subjects with a history of CSA but no psychopathology (resilient group; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session."
11120461|NCT01701258|EG010|Reported Event|CSA/RES-placebo (fMRI Session)|"After the screening visit, eligible subjects with a history of CSA but no psychopathology (resilient group; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session."
11120462|NCT01701258|EG011|Reported Event|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
11120463|NCT01701258|EG012|Reported Event|CSA/MDD-amisulpride (fMRI Session)|After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.
11120464|NCT01701258|EG013|Reported Event|CSA/MDD-placebo (fMRI Session)|"After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.~Many eligible CSA/MDD baseline participants did not complete this session."
11120465|NCT01701271|BG000|Baseline|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
11120466|NCT01701271|FG000|Participant Flow|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
11120467|NCT01701271|OG000|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
11120468|NCT01701271|OG000|Outcome|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
11120469|NCT01701271|EG000|Reported Event|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
11120470|NCT01701362|BG000|Baseline|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
11120471|NCT01701362|BG001|Baseline|Placebo|Participants randomized to receive placebo
11120472|NCT01701362|BG002|Baseline|Total|Total of all reporting groups
11120473|NCT01701362|FG000|Participant Flow|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
11120474|NCT01701362|FG001|Participant Flow|Placebo|Participants randomized to receive placebo
11348415|NCT04176406|BG000|Baseline|Enrolled Participants|The following numbers represent the baseline characteristics for the participants enrolled in the study, who performed only the behavioral task. None of these participants received rTMS
11348416|NCT04176406|FG000|Participant Flow|rTMS Over a Node Within the Fronto-parietal Network|"excitatory 5Hz rTMS will be applied over a node within the fronto-parietal network, defined via network analysis.~rTMS: excitatory 5Hz rTMS will be used"
10878709|NCT00453986|EG001|Reported Event|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
10878710|NCT00453986|EG002|Reported Event|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
10878711|NCT00453999|BG000|Baseline|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
10878712|NCT00453999|BG001|Baseline|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
11348417|NCT04176406|FG001|Participant Flow|Sham rTMS Over a Node Within the Fronto-parietal Network|"electrical sham coil applied over a node within the fronto-parietal network.~Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11006134|NCT01084538|OG000|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
11006135|NCT01084538|EG000|Reported Event|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
11006136|NCT01084551|BG000|Baseline|Placebo|0 mg/day for 13 weeks
11006137|NCT01084551|BG001|Baseline|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
11006138|NCT01084551|BG002|Baseline|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
11006139|NCT01084551|BG003|Baseline|Total|Total of all reporting groups
11006140|NCT01084551|FG000|Participant Flow|Placebo|0 mg/day for 13 weeks
11006141|NCT01084551|FG001|Participant Flow|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
11006142|NCT01084551|FG002|Participant Flow|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
11006143|NCT01084551|OG000|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
11006144|NCT01084551|OG001|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
11006145|NCT01084551|OG002|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
11006146|NCT01084551|EG000|Reported Event|Placebo|0 mg/day for 13 weeks
11006147|NCT01084551|EG001|Reported Event|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
11006148|NCT01084551|EG002|Reported Event|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
11006149|NCT01084603|BG000|Baseline|Overall Study|Full Safety Set
11006150|NCT01084603|FG000|Participant Flow|Overall Study|Full Safety Set
11006151|NCT01084603|OG000|Outcome|Oral Nicotine 1|1 administration of 1 mg
11006152|NCT01084603|OG001|Outcome|Oral Nicotine 2|2 administrations of 1 mg
11006153|NCT01084603|OG002|Outcome|Oral Nicotine 4|4 administrations of 1 mg
11006154|NCT01084603|OG003|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
11006155|NCT01084603|OG004|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
11006156|NCT01084603|OG000|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
11006157|NCT01084603|EG000|Reported Event|Oral Nicotine 1|1 administration of 1 mg
11006158|NCT01084603|EG001|Reported Event|Oral Nicotine 2|2 administrations of 1 mg
11006159|NCT01084603|EG002|Reported Event|Oral Nicotine 4|4 administrations of 1 mg
11006160|NCT01084603|EG003|Reported Event|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
11006161|NCT01084603|EG004|Reported Event|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
11006162|NCT01084655|BG000|Baseline|Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 200 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
11006163|NCT01084655|BG001|Baseline|Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
11006164|NCT01084655|BG002|Baseline|Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT).
11006165|NCT01084655|BG003|Baseline|Total|Total of all reporting groups
11006166|NCT01084655|FG000|Participant Flow|Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 200 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
11006167|NCT01084655|FG001|Participant Flow|Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
11006168|NCT01084655|FG002|Participant Flow|Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT).
11006169|NCT01084655|OG000|Outcome|Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 200 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
11120475|NCT01701362|OG000|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
11120476|NCT01701362|OG001|Outcome|Placebo|Participants randomized to receive placebo
11120477|NCT01701362|EG000|Reported Event|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
11120478|NCT01701362|EG001|Reported Event|Placebo|Participants randomized to receive placebo
11120479|NCT01701375|BG000|Baseline|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
11120480|NCT01701375|FG000|Participant Flow|Arm 1|"PD 0332991 125 was given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
11120481|NCT01701375|OG000|Outcome|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
11120482|NCT01701375|EG000|Reported Event|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
11120483|NCT01701401|BG000|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
11120484|NCT01701401|BG001|Baseline|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
11120485|NCT01701401|BG002|Baseline|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
11120486|NCT01701401|BG003|Baseline|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
11120487|NCT01701401|BG004|Baseline|Total|Total of all reporting groups
11120488|NCT01701401|FG000|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks
11120489|NCT01701401|FG001|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
11120490|NCT01701401|FG002|Participant Flow|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
11120491|NCT01701401|FG003|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
11120492|NCT01701401|OG000|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
11120493|NCT01701401|OG001|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
11120494|NCT01701401|OG002|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
11120495|NCT01701401|OG003|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
11120496|NCT01701401|EG000|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
11120497|NCT01701401|EG001|Reported Event|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
11120498|NCT01701401|EG002|Reported Event|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
11120499|NCT01701401|EG003|Reported Event|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
11120500|NCT01701414|BG000|Baseline|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
11120501|NCT01701414|BG001|Baseline|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
11120502|NCT01701414|BG002|Baseline|Total|Total of all reporting groups
11224442|NCT02360124|EG001|Reported Event|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
11120503|NCT01701414|FG000|Participant Flow|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
11120504|NCT01701414|FG001|Participant Flow|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
11120505|NCT01701414|OG000|Outcome|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
11120506|NCT01701414|OG001|Outcome|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
11120507|NCT01701414|EG000|Reported Event|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
11120508|NCT01701414|EG001|Reported Event|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
11120509|NCT01701505|BG000|Baseline|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120510|NCT01701505|BG001|Baseline|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
11120511|NCT01701505|BG002|Baseline|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
11120512|NCT01701505|BG003|Baseline|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120513|NCT01701505|BG004|Baseline|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
11120514|NCT01701505|BG005|Baseline|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120515|NCT01701505|BG006|Baseline|Total|Total of all reporting groups
11120516|NCT01701505|FG000|Participant Flow|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.
11120517|NCT01701505|FG001|Participant Flow|Cohort A: 12-17 Years Mid-Dose (200uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.
11120518|NCT01701505|FG002|Participant Flow|Cohort A: 12-17 Years HighDose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.
11120519|NCT01701505|FG003|Participant Flow|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120520|NCT01701505|FG004|Participant Flow|Cohort B: 7-11 Years Med Dose|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
11120521|NCT01701505|FG005|Participant Flow|Cohort C: 3-6 Years Low Dose|"120uL of Kovacaine Mist, as 2 sprays of 60uL~120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each"
11348418|NCT04176406|FG002|Participant Flow|rTMS Over the DLPFC|"excitatory 5Hz rTMS will be applied over the dorso-lateral prefrontal cortex showing the strongest fMRI activation.~rTMS: excitatory 5Hz rTMS will be used"
10878713|NCT00453999|BG002|Baseline|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
11120522|NCT01701505|OG000|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120523|NCT01701505|OG001|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
11120524|NCT01701505|OG002|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
11120525|NCT01701505|OG003|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120526|NCT01701505|OG004|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
11120527|NCT01701505|OG005|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120528|NCT01701505|OG000|Outcome|Kovacaine Mist High Dose|"400uL of Kovacaine Mist, as 2 sprays of 200uL.~400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each."
11120529|NCT01701505|OG001|Outcome|Kovacaine Mist Mid Dose|"200uL of Kovacaine Mist, as 2 sprays of 100uL.~200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each."
11120530|NCT01701505|OG002|Outcome|Kovacaine Mist Low Dose|"120uL of Kovacaine Mist, as 2 sprays of 60uL.~120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each."
11120531|NCT01701505|EG000|Reported Event|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120532|NCT01701505|EG001|Reported Event|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
11120533|NCT01701505|EG002|Reported Event|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
11120534|NCT01701505|EG003|Reported Event|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120535|NCT01701505|EG004|Reported Event|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
11120536|NCT01701505|EG005|Reported Event|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
11120537|NCT01701973|BG000|Baseline|Participants From All Groups|Data was collected as one group
11120538|NCT01701973|FG000|Participant Flow|Aim 1: Sitagliptin, Then Placebo|In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo.
11120539|NCT01701973|FG001|Participant Flow|Aim 1: Placebo, Then Sitagliptin|In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo.
11120540|NCT01701973|FG002|Participant Flow|Aim 2: Sitagliptin + Placebo,Then Sitagliptin + LNMMA|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either L-NMMA (L-N-Monomethyl-arginine) versus placebo.
11120541|NCT01701973|FG003|Participant Flow|Aim 2:Sitagliptin + LNMMA, Then Sitagliptin + Placebo|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either L-NMMA (L-N-Monomethyl-arginine) versus placebo.
11120542|NCT01701973|FG004|Participant Flow|Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Pegvisomant|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
11120543|NCT01701973|FG005|Participant Flow|Aim 2: Sitagliptin + Pegvisomant, Then Sitagliptin + Placebo|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
11120544|NCT01701973|FG006|Participant Flow|Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Exendin 9-39|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.
11120545|NCT01701973|FG007|Participant Flow|Aim 2: Sitagliptin + Exendin 9-39, Then Sitagliptin + Placebo|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.
11120546|NCT01701973|OG000|Outcome|Aim 1: Sitagliptin,Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
11120547|NCT01701973|OG001|Outcome|Aim 1: Placebo, Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
11120548|NCT01701973|OG002|Outcome|Aim 1: Sitagliptin, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
11120549|NCT01701973|OG003|Outcome|Aim 1: Placebo, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
11120550|NCT01701973|OG000|Outcome|Aim 1: Sitagliptin,Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm vascular resistance (FVR) was assessed during a 3 hour period following arginine stimulation.
11120551|NCT01701973|OG001|Outcome|Aim 1: Placebo, Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm vascular resistance (FVR) was assessed during a 3 hour period following arginine stimulation.
11120552|NCT01701973|OG002|Outcome|Aim 1: Sitagliptin, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm vascular resistance (FVR) was assessed during a 3 hour period following arginine stimulation.
11120553|NCT01701973|OG003|Outcome|Aim 1: Placebo, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm vascular resistance (FVR) was assessed during a 3 hour period following arginine stimulation.
11120554|NCT01701973|OG000|Outcome|Aim 1: Sitagliptin,Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm blood flow was assessed during a 3 hour period following arginine stimulation.
11120555|NCT01701973|OG001|Outcome|Aim 1: Placebo, Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm blood flow was assessed during a 3 hour period following arginine stimulation.
11120556|NCT01701973|OG002|Outcome|Aim 1: Sitagliptin, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm blood flow was assessed during a 3 hour period following arginine stimulation.
11120557|NCT01701973|OG003|Outcome|Aim 1: Placebo, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm blood flow was assessed during a 3 hour period following arginine stimulation.
11120558|NCT01701973|OG000|Outcome|Aim 2: Sitagliptin and LNMMA, Female Participants|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120559|NCT01701973|OG001|Outcome|Aim 2: Sitagliptin and Placebo, Females in LNMMA Group|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120560|NCT01701973|OG002|Outcome|Aim 2: Sitagliptin and LNMMA, Male Participants|Two of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120561|NCT01701973|OG003|Outcome|Aim 2: Sitagliptin and Placebo, Males in LNMMA Group|Two of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120562|NCT01701973|OG004|Outcome|Aim 2: Sitagliptin and Pegvisomant, Female Participants|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
11120563|NCT01701973|OG005|Outcome|Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
11120564|NCT01701973|OG006|Outcome|Aim 2: Sitagliptin and Exendin 9-39, Female Participants|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120565|NCT01701973|OG007|Outcome|Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120566|NCT01701973|OG008|Outcome|Aim 2: Sitagliptin and Exendin 9-39, Male Participant|One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120567|NCT01701973|OG009|Outcome|Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group|One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120568|NCT01701973|OG000|Outcome|Aim 2: Sitagliptin and LNMMA, Female Participants|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus LNMMA and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120569|NCT01701973|OG001|Outcome|Aim 2: Sitagliptin and Placebo, Females in LNMMA Group|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus LNMMA and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120570|NCT01701973|OG005|Outcome|Aim 2: Sitagliptin & Placebo,Females in Pegvisomant Group|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
11120571|NCT01701973|OG008|Outcome|Aim 2: Sitagliptin and Exendin 9-39, Male Participant|One of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120572|NCT01701973|OG009|Outcome|Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group|One of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120573|NCT01701973|OG000|Outcome|Aim 1: Sitagliptin,Female Participants|Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. tPA levels were assessed during a 3 hour period following arginine stimulation.
11120574|NCT01701973|OG001|Outcome|Aim 1: Placebo, Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. tPA levels were assessed during a 3 hour period following arginine stimulation.
11120575|NCT01701973|OG002|Outcome|Aim 1: Sitagliptin, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. tPA levels were assessed during a 3 hour period following arginine stimulation.
11120576|NCT01701973|OG003|Outcome|Aim 1: Placebo, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. tPA levels were assessed during a 3 hour period following arginine stimulation.
11120577|NCT01701973|OG000|Outcome|Aim 2: Sitagliptin and Placebo, Females in Pegvisomant Group|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120578|NCT01701973|OG001|Outcome|Aim 2: Sitagliptin and Pegvisomant, Female Participants|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion.
11120579|NCT01701973|EG000|Reported Event|Sitagliptin|Healthy lean adults completed a double blinded cross over study in which they took sitagliptin vs. placebo separated by a wash-out.
11120580|NCT01701973|EG001|Reported Event|Placebo|Healthy lean adults completed a double blinded cross over study in which they took sitagliptin vs. placebo separated by a wash-out.
11120581|NCT01701973|EG002|Reported Event|Sitagliptin Plus Pegvisomant|Five women from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus pre-treatment with pegvisomant.
11120582|NCT01701973|EG003|Reported Event|Sitagliptin Plus LNMMA|9 participants from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus L-N-mono-methylarginine (LNMMA).
11120583|NCT01701973|EG004|Reported Event|Sitagliptin Plus Exendin 9-39|8 participants from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus Exendin 9-39.
11120584|NCT01701999|BG000|Baseline|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
11120585|NCT01701999|BG001|Baseline|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
11120586|NCT01701999|BG002|Baseline|Total|Total of all reporting groups
11120587|NCT01701999|FG000|Participant Flow|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
11120588|NCT01701999|FG001|Participant Flow|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
11120589|NCT01701999|OG000|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
11120590|NCT01701999|OG001|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
11120591|NCT01701999|EG000|Reported Event|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
11120592|NCT01701999|EG001|Reported Event|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
11120593|NCT01702025|BG000|Baseline|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
11120594|NCT01702025|BG001|Baseline|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
11120595|NCT01702025|BG002|Baseline|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
11120596|NCT01702025|BG003|Baseline|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
11120597|NCT01702025|BG004|Baseline|Total|Total of all reporting groups
11120598|NCT01702025|FG000|Participant Flow|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
11120599|NCT01702025|FG001|Participant Flow|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
11120600|NCT01702025|FG002|Participant Flow|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
11120601|NCT01702025|FG003|Participant Flow|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
11120602|NCT01702025|OG000|Outcome|Normoxia Placebo|Placebo: single dose Normoxia
11120603|NCT01702025|OG001|Outcome|Hypoxia Placebo|Placebo: single dose hypoxia
11120604|NCT01702025|OG002|Outcome|Normoxia Aminophylline|Aminophylline:single dose Normoxia
11120605|NCT01702025|OG003|Outcome|Hypoxia Aminophylline|Aminophylline:single dose hypoxia
11120606|NCT01702025|OG004|Outcome|Normoxia Methazolamide|Methazolamide single dose Normoxia
11120607|NCT01702025|OG005|Outcome|Hypoxia Methazolamide|Methazolamide: single dose hypoxia
11120608|NCT01702025|OG006|Outcome|Normoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose normoxia
11120609|NCT01702025|OG007|Outcome|Hypoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose hypoxia
11120610|NCT01702025|EG000|Reported Event|Placebo|"Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia~."
11120611|NCT01702025|EG001|Reported Event|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
11120612|NCT01702025|EG002|Reported Event|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia
11120613|NCT01702025|EG003|Reported Event|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
11120614|NCT01702233|BG000|Baseline|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120615|NCT01702233|BG001|Baseline|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
10878714|NCT00453999|BG003|Baseline|Total|Total of all reporting groups
11120616|NCT01702233|BG002|Baseline|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120617|NCT01702233|BG003|Baseline|Total|Total of all reporting groups
11120618|NCT01702233|FG000|Participant Flow|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120619|NCT01702233|FG001|Participant Flow|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
11120620|NCT01702233|FG002|Participant Flow|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120621|NCT01702233|OG000|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120622|NCT01702233|OG001|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
11120623|NCT01702233|OG001|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120624|NCT01702233|OG002|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120625|NCT01702233|EG000|Reported Event|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120626|NCT01702233|EG001|Reported Event|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
11120627|NCT01702233|EG002|Reported Event|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
11120628|NCT01702246|BG000|Baseline|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
11120629|NCT01702246|FG000|Participant Flow|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
11120630|NCT01702246|OG000|Outcome|Baseline|prior to treatment with simvastatin
11120631|NCT01702246|OG001|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
11120632|NCT01702246|OG000|Outcome|Baseline Cholesterol|mean cholesterol level (mmol/L) prior to treatment with simvastatin
11120633|NCT01702246|OG001|Outcome|Simvastatin Treatment|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
11120634|NCT01702246|EG000|Reported Event|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
11120635|NCT01702259|BG000|Baseline|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
11120636|NCT01702259|BG001|Baseline|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
11120637|NCT01702259|BG002|Baseline|Total|Total of all reporting groups
11120638|NCT01702259|FG000|Participant Flow|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light."
11120639|NCT01702259|FG001|Participant Flow|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
11120640|NCT01702259|OG000|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
11120641|NCT01702259|OG001|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
11120642|NCT01702259|EG000|Reported Event|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
11120643|NCT01702259|EG001|Reported Event|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
11120644|NCT01702298|BG000|Baseline|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
11120645|NCT01702298|FG000|Participant Flow|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
11120646|NCT01702298|OG000|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
11120647|NCT01702298|EG000|Reported Event|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
11120648|NCT01702311|BG000|Baseline|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
11120649|NCT01702311|BG001|Baseline|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
11120650|NCT01702311|BG002|Baseline|Total|Total of all reporting groups
11120651|NCT01702311|FG000|Participant Flow|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
11120652|NCT01702311|FG001|Participant Flow|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
11120653|NCT01702311|OG000|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
11120654|NCT01702311|OG001|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
11120655|NCT01702311|OG000|Outcome|no Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
11120656|NCT01702311|OG001|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
11120657|NCT01702311|OG001|Outcome|no Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
11348419|NCT04176406|FG003|Participant Flow|Sham rTMS Over the DLPFC|"electrical sham coil applied over the DLPFC.~Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11120658|NCT01702311|EG000|Reported Event|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
11120659|NCT01702311|EG001|Reported Event|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
11120660|NCT01702363|BG000|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
11120661|NCT01702363|FG000|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
11120662|NCT01702363|OG000|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
11120663|NCT01702363|OG000|Outcome|MEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
11120664|NCT01702363|EG000|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
11120665|NCT01702428|BG000|Baseline|INV_MMR_L1 Group|Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120666|NCT01702428|BG001|Baseline|INV_MMR_L2 Group|Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120667|NCT01702428|BG002|Baseline|INV_MMR_L3 Group|Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11348420|NCT04176406|OG000|Outcome|Sham rTMS Over the DLPFC|"electrical sham coil applied over the DLPFC.~Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11120668|NCT01702428|BG003|Baseline|COM_MMR Group|Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
11120669|NCT01702428|BG004|Baseline|Total|Total of all reporting groups
11120670|NCT01702428|FG000|Participant Flow|INV_MMR_L1 Group|Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120671|NCT01702428|FG001|Participant Flow|INV_MMR_L2 Group|Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120672|NCT01702428|FG002|Participant Flow|INV_MMR_L3 Group|Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120673|NCT01702428|FG003|Participant Flow|COM_MMR Group|Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
11120674|NCT01702428|OG000|Outcome|INV_MMR _L1 Group|Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120675|NCT01702428|OG001|Outcome|INV_MMR _L2 Group|Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120676|NCT01702428|OG002|Outcome|INV_MMR _L3 Group|Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120677|NCT01702428|OG000|Outcome|INV_MMR_L1 Group|Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120678|NCT01702428|OG001|Outcome|INV_MMR_L2 Group|Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120679|NCT01702428|OG002|Outcome|INV_MMR_L3 Group|Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120680|NCT01702428|OG000|Outcome|INV_MMR Group|This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
11348421|NCT04176406|OG000|Outcome|rTMS Over a Node Within the Fronto-parietal Network|"excitatory 5Hz rTMS will be applied over a node within the fronto-parietal network, defined via network analysis.~rTMS: excitatory 5Hz rTMS will be used"
11120681|NCT01702428|OG001|Outcome|COM_MMR Group|Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
11120682|NCT01702428|OG003|Outcome|INV_MMR Group|This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
11120683|NCT01702428|OG004|Outcome|COM_MMR Group|Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
11120684|NCT01702428|EG000|Reported Event|INV_MMR_L1 Group|Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120685|NCT01702428|EG001|Reported Event|INV_MMR_L2 Group|Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120686|NCT01702428|EG002|Reported Event|INV_MMR_L3 Group|Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
11120687|NCT01702428|EG003|Reported Event|INV_MMR Group|This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
11120688|NCT01702428|EG004|Reported Event|COM_MMR Group|Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
11120689|NCT01702454|BG000|Baseline|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120690|NCT01702454|BG001|Baseline|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120691|NCT01702454|BG002|Baseline|Total|Total of all reporting groups
11120692|NCT01702454|FG000|Participant Flow|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120693|NCT01702454|FG001|Participant Flow|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120694|NCT01702454|OG000|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120695|NCT01702454|OG001|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11348422|NCT04176406|OG001|Outcome|Sham rTMS Over a Node Within the Fronto-parietal Network|"electrical sham coil applied over a node within the fronto-parietal network.~Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11348423|NCT04176406|OG002|Outcome|rTMS Over the DLPFC|"excitatory 5Hz rTMS will be applied over the dorso-lateral prefrontal cortex showing the strongest fMRI activation.~rTMS: excitatory 5Hz rTMS will be used"
11120696|NCT01702454|OG000|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NC T01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120697|NCT01702454|OG000|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
11120698|NCT01702454|OG001|Outcome|Fluarix Quadrivalent Unprimed Group|SuSubjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120699|NCT01702454|EG000|Reported Event|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120700|NCT01702454|EG001|Reported Event|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
11120701|NCT01702519|BG000|Baseline|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
11120702|NCT01702519|BG001|Baseline|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
11120703|NCT01702519|BG002|Baseline|Total|Total of all reporting groups
11120704|NCT01702519|FG000|Participant Flow|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
11120705|NCT01702519|FG001|Participant Flow|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
11120706|NCT01702519|OG000|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
11120707|NCT01702519|OG001|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
11120708|NCT01702519|OG000|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours
11120709|NCT01702519|OG001|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with reference adhesive, for 24 hours
11120710|NCT01702519|OG000|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
11120711|NCT01702519|OG001|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
11120712|NCT01702519|EG000|Reported Event|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
11120713|NCT01702519|EG001|Reported Event|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours
11120714|NCT01702532|BG000|Baseline|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
11120715|NCT01702532|BG001|Baseline|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes).
11120716|NCT01702532|BG002|Baseline|Total|Total of all reporting groups
11120717|NCT01702532|FG000|Participant Flow|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
11120718|NCT01702532|FG001|Participant Flow|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
11120719|NCT01702532|OG000|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
11120720|NCT01702532|OG001|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes)
11120721|NCT01702532|OG001|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes).
11348424|NCT04176406|OG003|Outcome|Sham rTMS Over the DLPFC|"electrical sham coil applied over the DLPFC.~Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11120722|NCT01702532|EG000|Reported Event|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
11120723|NCT01702532|EG001|Reported Event|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
11120724|NCT01702558|BG000|Baseline|Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120725|NCT01702558|BG001|Baseline|Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120726|NCT01702558|BG002|Baseline|Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape|In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11348425|NCT04176406|EG000|Reported Event|rTMS Over a Node Within the Fronto-parietal Network|"excitatory 5Hz rTMS will be applied over a node within the fronto-parietal network, defined via network analysis.~rTMS: excitatory 5Hz rTMS will be used"
11120727|NCT01702558|BG003|Baseline|Phase 2 (mBC): T-DM1 + Cape|In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120728|NCT01702558|BG004|Baseline|Phase 2 (mBC): T-DM1|In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.
11120729|NCT01702558|BG005|Baseline|Total|Total of all reporting groups
11120730|NCT01702558|FG000|Participant Flow|Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine (T-DM1) at a dose of 3.6 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine (Cape) at a dose level (DL) of 750 milligrams per meter squared (mg/m^2) via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, disease progression (PD), death, reasons deemed by the treating physician, or study termination by the sponsor.
11120731|NCT01702558|FG001|Participant Flow|Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120732|NCT01702558|FG002|Participant Flow|Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape|In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120733|NCT01702558|FG003|Participant Flow|Phase 2 (mBC): T-DM1 + Cape|In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
10878715|NCT00453999|FG000|Participant Flow|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
11120734|NCT01702558|FG004|Participant Flow|Phase 2 (mBC): T-DM1|In Phase 2, participants (with mBC) who were randomized in this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.
11120735|NCT01702558|OG000|Outcome|Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120736|NCT01702558|OG001|Outcome|Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120737|NCT01702558|OG000|Outcome|Phase 1 (mBC) Cohort 1: T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine at a dose level of 700 or 750 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120738|NCT01702558|OG000|Outcome|Phase 2 (mBC): T-DM1 + Cape|In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120739|NCT01702558|OG001|Outcome|Phase 2 (mBC): T-DM1|In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.
11120740|NCT01702558|OG000|Outcome|Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape|In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11348426|NCT04176406|EG001|Reported Event|Sham rTMS Over a Node Within the Fronto-parietal Network|"electrical sham coil applied over a node within the fronto-parietal network.~Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
10878716|NCT00453999|FG001|Participant Flow|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
10878717|NCT00453999|FG002|Participant Flow|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
11120741|NCT01702558|EG000|Reported Event|Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120742|NCT01702558|EG001|Reported Event|Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape|In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 [on Day 2 for Cycle 1] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120743|NCT01702558|EG002|Reported Event|Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape|In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120744|NCT01702558|EG003|Reported Event|Phase 2 (mBC): T-DM1 + Cape|In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
11120745|NCT01702558|EG004|Reported Event|Phase 2 (mBC): T-DM1|In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.
11120746|NCT01702844|BG000|Baseline|Nab Paclitaxel|"Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle~Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15"
11120747|NCT01702844|FG000|Participant Flow|Nab Paclitaxel|"Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle~Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15"
11120748|NCT01702844|OG000|Outcome|Nab Paclitaxel|"Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle~Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15"
11120749|NCT01702844|EG000|Reported Event|Nab Paclitaxel|"Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle~Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15"
11120750|NCT01702961|BG000|Baseline|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells~BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
11120751|NCT01702961|FG000|Participant Flow|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
11120752|NCT01702961|OG000|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
11120753|NCT01702961|EG000|Reported Event|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
11120754|NCT01702987|BG000|Baseline|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
11120755|NCT01702987|BG001|Baseline|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
11120756|NCT01702987|BG002|Baseline|Total|Total of all reporting groups
11120757|NCT01702987|FG000|Participant Flow|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
11120758|NCT01702987|FG001|Participant Flow|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
11120759|NCT01702987|OG000|Outcome|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
11120760|NCT01702987|OG001|Outcome|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
11120761|NCT01702987|EG000|Reported Event|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
11348427|NCT04176406|EG002|Reported Event|rTMS Over the DLPFC|"excitatory 5Hz rTMS will be applied over the dorso-lateral prefrontal cortex showing the strongest fMRI activation.~rTMS: excitatory 5Hz rTMS will be used"
11120762|NCT01702987|EG001|Reported Event|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
11120763|NCT01703000|BG000|Baseline|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
11120764|NCT01703000|FG000|Participant Flow|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
11120765|NCT01703000|OG000|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
11120766|NCT01703000|EG000|Reported Event|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
11120767|NCT01703039|BG000|Baseline|Sertraline + Riluzole|"sertraline 100 mg po daily and riluzole 50 mg po bid~Riluzole~Sertraline"
11120768|NCT01703039|BG001|Baseline|Sertraline + Placebo|"sertraline 100 mg po daily and placebo~Sertraline~placebo"
11120769|NCT01703039|BG002|Baseline|Total|Total of all reporting groups
11120770|NCT01703039|FG000|Participant Flow|Sertraline + Riluzole|"sertraline 100 mg po daily and riluzole 50 mg po bid~Riluzole~Sertraline"
11120771|NCT01703039|FG001|Participant Flow|Sertraline + Placebo|"sertraline 100 mg po daily and placebo~Sertraline~placebo"
11120772|NCT01703039|OG000|Outcome|Sertraline + Riluzole|sert 100mg po daily and riluzole...
11120773|NCT01703039|OG001|Outcome|Sertraline + Placebo|sert 100mg po daily and placebo...
11120774|NCT01703039|OG000|Outcome|Sertraline + Riluzole|"sertraline 100 mg po daily and riluzole 50 mg po bid~Riluzole~Sertraline"
11120775|NCT01703039|OG001|Outcome|Sertraline + Placebo|"sertraline 100 mg po daily and placebo~Sertraline~placebo"
11120776|NCT01703039|EG000|Reported Event|Sertraline + Riluzole|"sertraline 100 mg po daily and riluzole 50 mg po bid~Riluzole~Sertraline"
11120777|NCT01703039|EG001|Reported Event|Sertraline + Placebo|"sertraline 100 mg po daily and placebo~Sertraline~placebo"
11120778|NCT01703065|BG000|Baseline|Cabozantinib in Metastatic CRPC|"Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120779|NCT01703065|BG001|Baseline|Cabozantinib in Non-metastatic CRPC|"Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120780|NCT01703065|BG002|Baseline|Total|Total of all reporting groups
11120781|NCT01703065|FG000|Participant Flow|Cabozantinib in Metastatic CRPC|"Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120782|NCT01703065|FG001|Participant Flow|Cabozantinib in Non-metastatic CRPC|"Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120783|NCT01703065|OG000|Outcome|Cabozantinib in Non-metastatic CRPC|"Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120784|NCT01703065|OG000|Outcome|Cabozantinib in Metastatic CRPC|"Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120785|NCT01703065|OG001|Outcome|Cabozantinib in Non-metastatic CRPC|"Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120786|NCT01703065|EG000|Reported Event|Cabozantinib in Metastatic CRPC|"Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120787|NCT01703065|EG001|Reported Event|Cabozantinib in Non-metastatic CRPC|"Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.~Cabozantinib: Given orally once a day"
11120788|NCT01703091|BG000|Baseline|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
11120789|NCT01703091|BG001|Baseline|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
11120790|NCT01703091|BG002|Baseline|Total|Total of all reporting groups
11120791|NCT01703091|FG000|Participant Flow|Ramucirumab Plus Docetaxel|Ramucirumab 10 milligrams/kilogram (mg/kg) administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 milligrams/square meter (mg/m2) administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
11120792|NCT01703091|FG001|Participant Flow|Placebo Plus Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
11120793|NCT01703091|OG000|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
11120794|NCT01703091|OG001|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
11120795|NCT01703091|EG000|Reported Event|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
11120796|NCT01703091|EG001|Reported Event|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
11120797|NCT01703117|BG000|Baseline|Placebo|Matching placebo twice a day
11120798|NCT01703117|BG001|Baseline|Riluzole|Riluzole 50mg twice a day
11120799|NCT01703117|BG002|Baseline|Total|Total of all reporting groups
11120800|NCT01703117|FG000|Participant Flow|Riluzole|Riluzole 50mg twice a day
11120801|NCT01703117|FG001|Participant Flow|Placebo|Matching placebo twice a day
11120802|NCT01703117|OG000|Outcome|Placebo|Matching placebo twice a day
11120803|NCT01703117|OG001|Outcome|Riluzole|Riluzole 50mg twice a day
11120804|NCT01703117|OG000|Outcome|Riluzole|Riluzole 50mg twice a day
11120805|NCT01703117|OG001|Outcome|Placebo|Matching placebo twice a day
11120806|NCT01703117|EG000|Reported Event|Riluzole|Riluzole 50mg twice a day
11120807|NCT01703117|EG001|Reported Event|Placebo|Matching placebo twice a day
11120808|NCT01703169|BG000|Baseline|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
11120809|NCT01703169|FG000|Participant Flow|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
11120810|NCT01703169|OG000|Outcome|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
11348428|NCT04176406|EG003|Reported Event|Sham rTMS Over the DLPFC|"electrical sham coil applied over the DLPFC.~Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11348429|NCT04175262|BG000|Baseline|Sunitinib Following Immune-oncologic Therapy|Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
11348430|NCT04175262|FG000|Participant Flow|Sunitinib Following Immune-oncologic Therapy|Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
11120811|NCT01703169|EG000|Reported Event|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
11120812|NCT01703208|BG000|Baseline|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
11120813|NCT01703208|BG001|Baseline|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
11120814|NCT01703208|BG002|Baseline|Total|Total of all reporting groups
11120815|NCT01703208|FG000|Participant Flow|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
11120816|NCT01703208|FG001|Participant Flow|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
11120817|NCT01703208|OG000|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
11120818|NCT01703208|OG001|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
11120819|NCT01703208|EG000|Reported Event|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
11120820|NCT01703208|EG001|Reported Event|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
11120821|NCT01703221|BG000|Baseline|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
11120822|NCT01703221|BG001|Baseline|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
11120823|NCT01703221|BG002|Baseline|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
11120824|NCT01703221|BG003|Baseline|Total|Total of all reporting groups
11120825|NCT01703221|FG000|Participant Flow|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
11120826|NCT01703221|FG001|Participant Flow|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
11120827|NCT01703221|FG002|Participant Flow|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
11120828|NCT01703221|OG000|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
11120829|NCT01703221|OG001|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
11120830|NCT01703221|OG002|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
11120831|NCT01703221|OG000|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
11120832|NCT01703221|OG001|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
11120833|NCT01703221|OG002|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
11120834|NCT01703221|EG000|Reported Event|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
11120835|NCT01703221|EG001|Reported Event|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
11120836|NCT01703221|EG002|Reported Event|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
11120837|NCT01703221|EG003|Reported Event|Omarigliptin (Phase A + B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
11120838|NCT01703221|EG004|Reported Event|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
11120839|NCT01703221|EG005|Reported Event|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
11120840|NCT01703260|BG000|Baseline|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
11120841|NCT01703260|BG001|Baseline|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
11120842|NCT01703260|BG002|Baseline|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
11120843|NCT01703260|BG003|Baseline|Total|Total of all reporting groups
11120844|NCT01703260|FG000|Participant Flow|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
11120845|NCT01703260|FG001|Participant Flow|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
11120846|NCT01703260|FG002|Participant Flow|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
11120847|NCT01703260|OG000|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
11120848|NCT01703260|OG001|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
11120849|NCT01703260|OG002|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
11120850|NCT01703260|EG000|Reported Event|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
11120851|NCT01703260|EG001|Reported Event|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
11120852|NCT01703260|EG002|Reported Event|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
11120853|NCT01703286|BG000|Baseline|Total Participants|All study participants
11120854|NCT01703286|FG000|Participant Flow|Pbo/ G1-4/ L 5|Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
11120855|NCT01703286|FG001|Participant Flow|L 5/ G 1-4/ Pbo|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days
11120856|NCT01703286|FG002|Participant Flow|G 1-4/ L 5/ Pbo|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days
11120857|NCT01703286|FG003|Participant Flow|G1-4/ Pbo/ L 5|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
11120858|NCT01703286|FG004|Participant Flow|Pbo/ L 5/ G1-4|Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
11120859|NCT01703286|FG005|Participant Flow|L 5/ Pbo/ G1-4/|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
11120860|NCT01703286|OG000|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
11120861|NCT01703286|OG001|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
11120862|NCT01703286|OG002|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
11120863|NCT01703286|OG003|Outcome|REP - Linagliptin 5 mg|Residual effect period - Linagliptin 5 mg
11120864|NCT01703286|OG004|Outcome|REP - Glimepiride 1-4 mg|Residual effect period - Glimepiride 1-4 mg
11120865|NCT01703286|OG005|Outcome|Rep - Placebo|Residual effect period - Placebo
11120866|NCT01703286|EG000|Reported Event|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
11120867|NCT01703286|EG001|Reported Event|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
11120868|NCT01703286|EG002|Reported Event|Placebo|Placebo: matching Linagliptin or Glimepiride given once daily over 28 days
11120869|NCT01703507|BG000|Baseline|Arm A (Ipilimumab and Whole Brain Radiation Therapy)|"Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.~Ipilimumab: Given IV~Whole-Brain Radiation Therapy (WBRT): Undergo WBRT"
11120870|NCT01703507|BG001|Baseline|Arm B (Ipilimumab and Stereotactic Radiosurgery)|"Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.~Ipilimumab: Given IV~Stereotactic Radiosurgery (SRS): Undergo SRS"
11120871|NCT01703507|BG002|Baseline|Total|Total of all reporting groups
11120872|NCT01703507|FG000|Participant Flow|Arm A (Ipilimumab and Whole Brain Radiation Therapy)|"Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.~Ipilimumab: Given IV~Whole-Brain Radiation Therapy (WBRT): Undergo WBRT"
11120873|NCT01703507|FG001|Participant Flow|Arm B (Ipilimumab and Stereotactic Radiosurgery)|"Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.~Ipilimumab: Given IV~Stereotactic Radiosurgery (SRS): Undergo SRS"
11120874|NCT01703507|OG000|Outcome|Arm A (Ipilimumab and Whole Brain Radiation Therapy)|"Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.~Ipilimumab: Given IV~Whole-Brain Radiation Therapy (WBRT): Undergo WBRT"
11120875|NCT01703507|OG001|Outcome|Arm B (Ipilimumab and Stereotactic Radiosurgery)|"Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.~Ipilimumab: Given IV~Stereotactic Radiosurgery (SRS): Undergo SRS"
11120876|NCT01703507|EG000|Reported Event|Arm A (Ipilimumab and Whole Brain Radiation Therapy)|"Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.~Ipilimumab: Given IV~Whole-Brain Radiation Therapy (WBRT): Undergo WBRT"
11120877|NCT01703507|EG001|Reported Event|Arm B (Ipilimumab and Stereotactic Radiosurgery)|"Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.~Ipilimumab: Given IV~Stereotactic Radiosurgery (SRS): Undergo SRS"
11120878|NCT01703598|BG000|Baseline|DBS Surgery|"Single arm~Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes~DBS surgery: Placement of DBS electrodes"
11120879|NCT01703598|FG000|Participant Flow|DBS Surgery|"Single arm~Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes~DBS surgery: Placement of DBS electrodes"
11120880|NCT01703598|OG000|Outcome|DBS Surgery|"Single arm~Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes~DBS surgery: Placement of DBS electrodes"
11120881|NCT01703598|EG000|Reported Event|DBS Surgery|"Single arm~Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes~DBS surgery: Placement of DBS electrodes"
11120882|NCT01703663|BG000|Baseline|All Participants|
11120883|NCT01703663|FG000|Participant Flow|EPAP Therapy First Night, Then Control Night|During the first night, the subject was assigned to wear EPAP. During the second night, the subject did not wear EPAP (control night). During both nights, sleep disordered breathing was monitored with the WatchPAT device.
11120884|NCT01703663|FG001|Participant Flow|Control Night First Night, EPAP Therapy Second Night|During the first night, the subject was assigned to no EPAP (control night). During the second night, the subject was assigned to wear EPAP. During both nights, sleep disordered breathing was monitored with the WatchPAT device.
11120885|NCT01703663|OG000|Outcome|EPAP Night|Raw data from EPAP night (not taking into account period effect).
11120886|NCT01703663|OG001|Outcome|Control Night|Raw data from control night (not taking into account period effect).
11120887|NCT01703663|EG000|Reported Event|EPAP Night|
11120888|NCT01703663|EG001|Reported Event|Control Night|
11120889|NCT01703702|BG000|Baseline|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
11120890|NCT01703702|BG001|Baseline|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
11120891|NCT01703702|BG002|Baseline|Total|Total of all reporting groups
11120892|NCT01703702|FG000|Participant Flow|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
11120893|NCT01703702|FG001|Participant Flow|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
11120894|NCT01703702|OG000|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
11120895|NCT01703702|OG001|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
11120896|NCT01703702|OG000|Outcome|Mild Impairment AB+|Patients diagnosed with a cognitive status of mild impairment and AB+ scan result.
11120897|NCT01703702|OG001|Outcome|Mild Impairment AB-|Patients diagnosed with a cognitive status of mild impairment and AB- scan result.
11120898|NCT01703702|OG000|Outcome|Intervention Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their baseline clinical diagnosis.
11120899|NCT01703702|OG001|Outcome|Control Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their initial diagnosis
11120900|NCT01703702|OG000|Outcome|Intervention Scan/Diagnosis Concordant|Intervention arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
11120901|NCT01703702|OG001|Outcome|Control Scan/Diagnosis Concordant|Control arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
11120902|NCT01703702|EG000|Reported Event|Safety Population|620 patients received florbetapir (18F) and comprise the Safety Population.
11120903|NCT01703741|BG000|Baseline|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
11120904|NCT01703741|FG000|Participant Flow|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
11120905|NCT01703741|OG000|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
11120906|NCT01703741|EG000|Reported Event|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 during the 000023 study. The dose was further down titrated based on serum testosterone levels. Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
11120907|NCT01703819|BG000|Baseline|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to~-30 minutes~Neurexan®"
11120908|NCT01703819|BG001|Baseline|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
11120909|NCT01703819|BG002|Baseline|Total|Total of all reporting groups
11120910|NCT01703819|FG000|Participant Flow|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
11120911|NCT01703819|FG001|Participant Flow|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
11120912|NCT01703819|OG000|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
11120913|NCT01703819|OG001|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
11120914|NCT01703819|EG000|Reported Event|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
11120915|NCT01703819|EG001|Reported Event|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
11120916|NCT01703832|BG000|Baseline|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
11120917|NCT01703832|BG001|Baseline|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
11120918|NCT01703832|BG002|Baseline|Total|Total of all reporting groups
11120919|NCT01703832|FG000|Participant Flow|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
11120920|NCT01703832|FG001|Participant Flow|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
11120921|NCT01703832|OG000|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
11120922|NCT01703832|OG001|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
10878718|NCT00453999|OG000|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
11120923|NCT01703832|EG000|Reported Event|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
11120924|NCT01703832|EG001|Reported Event|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
11120925|NCT01703845|BG000|Baseline|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120926|NCT01703845|BG001|Baseline|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120927|NCT01703845|BG002|Baseline|Total|Total of all reporting groups
11120928|NCT01703845|FG000|Participant Flow|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120929|NCT01703845|FG001|Participant Flow|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120930|NCT01703845|OG000|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120931|NCT01703845|OG001|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120932|NCT01703845|OG000|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120933|NCT01703845|OG001|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120934|NCT01703845|EG000|Reported Event|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11120935|NCT01703845|EG001|Reported Event|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
11224443|NCT02360124|EG002|Reported Event|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
11224444|NCT02360215|BG000|Baseline|HA-WBRT + Memantine|Whole brain radiation therapy (WBRT) and memantine
11224445|NCT02360215|BG001|Baseline|WBRT + Memantine|Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) and memantine
11120936|NCT01703858|BG000|Baseline|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
11120937|NCT01703858|BG001|Baseline|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
11120938|NCT01703858|BG002|Baseline|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
11120939|NCT01703858|BG003|Baseline|Total|Total of all reporting groups
11120940|NCT01703858|FG000|Participant Flow|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
11120941|NCT01703858|FG001|Participant Flow|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
11120942|NCT01703858|FG002|Participant Flow|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
11120943|NCT01703858|OG000|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
11120944|NCT01703858|OG001|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
11120945|NCT01703858|OG002|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
11120946|NCT01703858|OG003|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
11120947|NCT01703858|OG004|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
11120948|NCT01703858|EG000|Reported Event|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
11120949|NCT01703858|EG001|Reported Event|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
11120950|NCT01703858|EG002|Reported Event|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
11120951|NCT01703858|EG003|Reported Event|Pantoprazole 40mg|Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
11224446|NCT02360215|BG002|Baseline|Total|Total of all reporting groups
11224447|NCT02360215|FG000|Participant Flow|HA-WBRT + Memantine|Whole brain radiation therapy (WBRT) and memantine
11120952|NCT01703858|EG004|Reported Event|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
11120953|NCT01703858|EG005|Reported Event|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
11120954|NCT01703988|BG000|Baseline|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
11120955|NCT01703988|BG001|Baseline|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
11120956|NCT01703988|BG002|Baseline|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
11120957|NCT01703988|BG003|Baseline|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
11120958|NCT01703988|BG004|Baseline|Total|Total of all reporting groups
11120959|NCT01703988|FG000|Participant Flow|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, intrathecal (IT) injection
11120960|NCT01703988|FG001|Participant Flow|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
11120961|NCT01703988|FG002|Participant Flow|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
11120962|NCT01703988|FG003|Participant Flow|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
11120963|NCT01703988|OG000|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
11120964|NCT01703988|OG001|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
11120965|NCT01703988|OG002|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
11120966|NCT01703988|OG003|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
11120967|NCT01703988|OG000|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
11120968|NCT01703988|EG000|Reported Event|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
11120969|NCT01703988|EG001|Reported Event|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
11120970|NCT01703988|EG002|Reported Event|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
11120971|NCT01703988|EG003|Reported Event|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
11120972|NCT01704079|BG000|Baseline|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11120973|NCT01704079|BG001|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11120974|NCT01704079|BG002|Baseline|Total|Total of all reporting groups
11120975|NCT01704079|FG000|Participant Flow|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11120976|NCT01704079|FG001|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11120977|NCT01704079|OG000|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11120978|NCT01704079|OG001|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11120979|NCT01704079|EG000|Reported Event|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11120980|NCT01704079|EG001|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
11120981|NCT01704196|BG000|Baseline|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
11120982|NCT01704196|BG001|Baseline|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
11120983|NCT01704196|BG002|Baseline|Total|Total of all reporting groups
11120984|NCT01704196|FG000|Participant Flow|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
11120985|NCT01704196|FG001|Participant Flow|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
11120986|NCT01704196|OG000|Outcome|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
11120987|NCT01704196|OG001|Outcome|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
10845262|NCT00266032|BG000|Baseline|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
11120988|NCT01704196|EG000|Reported Event|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
11120989|NCT01704196|EG001|Reported Event|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
11120990|NCT01704261|BG000|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
11120991|NCT01704261|BG001|Baseline|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
11120992|NCT01704261|BG002|Baseline|Total|Total of all reporting groups
11120993|NCT01704261|FG000|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
11120994|NCT01704261|FG001|Participant Flow|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
11120995|NCT01704261|OG000|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
11120996|NCT01704261|OG001|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
11120997|NCT01704261|EG000|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
11120998|NCT01704261|EG001|Reported Event|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
11120999|NCT01704287|BG000|Baseline|Pembrolizumab 2 mg/kg|Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121000|NCT01704287|BG001|Baseline|Pembrolizumab 10 mg/kg|Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121001|NCT01704287|BG002|Baseline|Investigator-Choice Chemotherapy (ICC)|Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121002|NCT01704287|BG003|Baseline|Total|Total of all reporting groups
10878719|NCT00453999|OG001|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
11121003|NCT01704287|FG000|Participant Flow|Pembrolizumab 2 mg/kg|Participants were initially randomized to receive pembrolizumab 2 mg/kg intravenously (IV) once every 3 weeks (Q3W). With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121004|NCT01704287|FG001|Participant Flow|Pembrolizumab 10 mg/kg|Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121005|NCT01704287|FG002|Participant Flow|Investigator-Choice Chemotherapy (ICC)|Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121006|NCT01704287|FG003|Participant Flow|ICC→Pembrolizumab 2 mg/kg|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121007|NCT01704287|FG004|Participant Flow|ICC→Pembrolizumab 10 mg/kg|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121008|NCT01704287|OG000|Outcome|Pembrolizumab 2 mg/kg|Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121009|NCT01704287|OG001|Outcome|Pembrolizumab 10 mg/kg|Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121010|NCT01704287|OG002|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121011|NCT01704287|OG000|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121012|NCT01704287|OG001|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121013|NCT01704287|OG002|Outcome|ICC Only|Participants were randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121014|NCT01704287|OG003|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121015|NCT01704287|OG004|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121016|NCT01704287|OG005|Outcome|ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121017|NCT01704287|OG006|Outcome|ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121018|NCT01704287|EG000|Reported Event|Investigator-Choice Chemotherapy (ICC) Only|Participants received 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the final analysis. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11224448|NCT02360215|FG001|Participant Flow|WBRT + Memantine|Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) and memantine
11224449|NCT02360215|OG000|Outcome|HA-WBRT + Memantine|Whole brain radiation therapy (WBRT) and memantine
11121019|NCT01704287|EG001|Reported Event|ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab)|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121020|NCT01704287|EG002|Reported Event|ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab)|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121021|NCT01704287|EG003|Reported Event|Pembrolizumab 2 mg/kg|Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121022|NCT01704287|EG004|Reported Event|Pembrolizumab 10 mg/kg|Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
11121023|NCT01704287|EG005|Reported Event|ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)|Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121024|NCT01704287|EG006|Reported Event|ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)|Participants who were initiall randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
11121025|NCT01704456|BG000|Baseline|Mindfulness-based Cognitive Therapy (MBCT)|"Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.~Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain."
11121026|NCT01704456|BG001|Baseline|Cognitive Behavioural Therapy (CBT)|"Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.~Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training."
11121027|NCT01704456|BG002|Baseline|Total|Total of all reporting groups
11121028|NCT01704456|FG000|Participant Flow|Mindfulness-based Cognitive Therapy (MBCT)|"Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.~Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain."
11121029|NCT01704456|FG001|Participant Flow|Cognitive Behavioural Therapy (CBT)|"Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.~Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training."
11224450|NCT02360215|OG001|Outcome|WBRT + Memantine|Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) and memantine
11121030|NCT01704456|OG000|Outcome|Mindfulness-based Cognitive Therapy (MBCT)|"Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.~Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain."
11121031|NCT01704456|OG001|Outcome|Cognitive Behavioural Therapy (CBT)|"Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.~Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training."
11121032|NCT01704456|EG000|Reported Event|Mindfulness-based Cognitive Therapy (MBCT)|"Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.~Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain."
11121033|NCT01704456|EG001|Reported Event|Cognitive Behavioural Therapy (CBT)|"Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.~Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training."
11121034|NCT01704495|BG000|Baseline|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
11121035|NCT01704495|BG001|Baseline|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
11121036|NCT01704495|BG002|Baseline|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
11121037|NCT01704495|BG003|Baseline|Placebo|Placebo oral capsules self-administred twice daily
11121038|NCT01704495|BG004|Baseline|Total|Total of all reporting groups
11121039|NCT01704495|FG000|Participant Flow|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
11121040|NCT01704495|FG001|Participant Flow|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
11121041|NCT01704495|FG002|Participant Flow|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
11121042|NCT01704495|FG003|Participant Flow|Placebo|Placebo oral capsules self-administred twice daily
11121043|NCT01704495|OG000|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
11121044|NCT01704495|OG001|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
11121045|NCT01704495|OG002|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
11121046|NCT01704495|OG003|Outcome|Placebo|Placebo oral capsules self-administred twice daily
11121047|NCT01704495|EG000|Reported Event|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
11121048|NCT01704495|EG001|Reported Event|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
11121049|NCT01704495|EG002|Reported Event|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
11121050|NCT01704495|EG003|Reported Event|Placebo|Placebo oral capsules self-administered twice daily
11121051|NCT01704521|BG000|Baseline|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin.
11121052|NCT01704521|BG001|Baseline|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin.
11121053|NCT01704521|BG002|Baseline|Total|Total of all reporting groups
11121054|NCT01704521|FG000|Participant Flow|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
11121055|NCT01704521|FG001|Participant Flow|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
11121056|NCT01704521|OG000|Outcome|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
10878720|NCT00453999|OG002|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
11121057|NCT01704521|OG001|Outcome|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration PegInterferon + Ribavirin
11121058|NCT01704521|EG000|Reported Event|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
11121059|NCT01704521|EG001|Reported Event|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
11121060|NCT01704599|BG000|Baseline|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
11121061|NCT01704599|FG000|Participant Flow|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
11121062|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
11121063|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis evaluated at week 0 on no systemic psoriasis medication; weeks 16 after 16 weeks adalimumab and 28 after 16 weeks adalimumab then 12 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
11121064|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis evaluated at after week 16 of study on or after of adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and vitamin B12 or during the 10 weeks after that.
11121065|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult 18-65 year old adults with moderate to severe plaque psoriasis with adverse event documented sometime during the 28 week study plus telephone call day 70 post week 28 visit either with knowledge of serious event of adverse event documented from data taken weeks 4 and 16 on adalimumab alone and week 28 after 16 weeks on adalimumab plus 12 weeks on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12 and a telephone call day 70 post week 28 study visit and a telephone call day 70 post week 28 visit.
11121066|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication; week 16 on adalimumab for 16 weeks and then week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
11121067|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis with subject serum levels to be measured weeks 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab and then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
11121068|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult subjects ages 18-65 with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication ,week 16 after 16 wqeeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus folic acid 5 mg. vitamin B6 100 mg and vitamin B12 1000 mcg daily assessing CBC with diferential for increase, decrease and no change.
11121069|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adult 18-65 year old moderate to severe plaque psoriasis patients with levels measured weeks 0,16 and 28 in 4 subjects; weeks 0 and 16 in one subject, weeks 16 and 28 in one subject and week 0 only in 2 subjects.
11121070|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 all with moderate to severe plaque psoriasis. Week 0 (on no systemic psoriasis medication), Week 16 ( 16 weeks adalimumab), Week 28 ( 16 weeks on adalimumab plus 12 weeks on adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12 daily.
11121071|NCT01704599|OG000|Outcome|Humira Plus 3 B Vitamins|adults 18-65 with plaque psoriasis (moderate to severe) measured at week 0 on no systemic psoriasis medication; week 16 after 16 weeks adalimumab and at 28 weeks after 16 weeks adalimumab plus 12 weeks folic acid, vitamin B6 and B12.
11121072|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis.
11121073|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 years with moderate to severe plaque psoriasis measured at week 16 after 16 weeks adalimumab and week 28 after 28 weeks adalimumab annd 12 weeks on adalimumab, folic acid 5 mg, 100 mg B6 and 1000 mcg B12.
11121074|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab and daily 5 mg folic acid 100 mg vitamin B6 and 1000 mcg B12.
11121075|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages18-65 with moderate to severe plaque psoriasis tested at week 0 on no systemic psoriasis therapy; week 16 after 16 weeks of adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12.
11121076|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|One adult psoriasis subject age 23 with moderate to severe plaque psoriasis with pregnanacy test on enrollment on no systemic psoriasis therapy.
11121077|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Subjects were adults with moderate to severe plaque psoriasis with test to be measured week 0 on no systemic psoriasis medication, week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
11121078|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Temperature measurements in adults ages 18-65 with moderate to severe plaque psoriasis at week16 on adalimuamb and week 28 temperatures on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
11121079|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults age 18-65 yearswith moderate to severe plaque psoriasis measured at week 0 of study on no systemic psoriasis medication.
11121080|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis. Weight measurement were in pounds measured at Weeks 16 and 28.
11121081|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages 18-65 with moderate to severe plaque psoriasis with PASI measured week 0 on no systemic psoriasis medication, weeks 4 and 16 after 4 and 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab and 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12 ranked by calculated Body Mass Index (BMI) week 0.
11121082|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue. Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
11121083|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks."
11121084|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject."
11121085|NCT01704599|OG000|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks (week 28)."
11121086|NCT01704599|EG000|Reported Event|Humira Then Humira Plus 3 B Vitamins|Pneumonia while on adaimumab and before the adalimumab plus B vitamins were begun.prior to vitamins
11121087|NCT01704651|BG000|Baseline|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
11121088|NCT01704651|BG001|Baseline|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
11121089|NCT01704651|BG002|Baseline|Total|Total of all reporting groups
11121090|NCT01704651|FG000|Participant Flow|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
11121091|NCT01704651|FG001|Participant Flow|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
11121092|NCT01704651|OG000|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
11121093|NCT01704651|OG001|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
11121094|NCT01704651|EG000|Reported Event|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
11121095|NCT01704651|EG001|Reported Event|Placebo|Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..
10878721|NCT00453999|OG001|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
11121096|NCT01704755|BG000|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
11121097|NCT01704755|BG001|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
11121098|NCT01704755|BG002|Baseline|Total|Total of all reporting groups
11121099|NCT01704755|FG000|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
11121100|NCT01704755|FG001|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
11121101|NCT01704755|OG000|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
11121102|NCT01704755|OG001|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
11121103|NCT01704755|EG000|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
11224451|NCT02360215|OG001|Outcome|WBRT + Memantin|Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) and memantine
11121104|NCT01704755|EG001|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
11121105|NCT01704781|BG000|Baseline|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
11121106|NCT01704781|BG001|Baseline|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
11121107|NCT01704781|BG002|Baseline|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
11121108|NCT01704781|BG003|Baseline|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121109|NCT01704781|BG004|Baseline|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121110|NCT01704781|BG005|Baseline|Total|Total of all reporting groups
11121111|NCT01704781|FG000|Participant Flow|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
11121112|NCT01704781|FG001|Participant Flow|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
11121113|NCT01704781|FG002|Participant Flow|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
11121114|NCT01704781|FG003|Participant Flow|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121115|NCT01704781|FG004|Participant Flow|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121116|NCT01704781|OG000|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
11121117|NCT01704781|OG001|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
11121118|NCT01704781|OG002|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
11121119|NCT01704781|OG000|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121120|NCT01704781|OG001|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121121|NCT01704781|OG003|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121122|NCT01704781|OG004|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121123|NCT01704781|EG000|Reported Event|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
11121124|NCT01704781|EG001|Reported Event|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
11121125|NCT01704781|EG002|Reported Event|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
11224452|NCT02360215|EG000|Reported Event|HA-WBRT + Memantine|Whole brain radiation therapy (WBRT) and memantine
11121126|NCT01704781|EG003|Reported Event|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121127|NCT01704781|EG004|Reported Event|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
11121128|NCT01704846|BG000|Baseline|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
11121129|NCT01704846|BG001|Baseline|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
11121130|NCT01704846|BG002|Baseline|Total|Total of all reporting groups
11121131|NCT01704846|FG000|Participant Flow|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
11121132|NCT01704846|FG001|Participant Flow|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
11121133|NCT01704846|OG000|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
11121134|NCT01704846|OG001|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
11121135|NCT01704846|EG000|Reported Event|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
11121136|NCT01704846|EG001|Reported Event|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
11121137|NCT01704976|BG000|Baseline|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
11121138|NCT01704976|BG001|Baseline|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
11121139|NCT01704976|BG002|Baseline|Total|Total of all reporting groups
11121140|NCT01704976|FG000|Participant Flow|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
11121141|NCT01704976|FG001|Participant Flow|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
11121142|NCT01704976|OG000|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
11121143|NCT01704976|OG001|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
11121144|NCT01704976|EG000|Reported Event|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
11121145|NCT01704976|EG001|Reported Event|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
11121146|NCT01705080|BG000|Baseline|A - EnligHTN for Severe Resistant HTN|"Office systolic Blood Pressure ≥160 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11224453|NCT02360215|EG001|Reported Event|WBRT + Memantin|Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) and memantine
11224454|NCT02360228|BG000|Baseline|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
11224455|NCT02360228|BG001|Baseline|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
11224456|NCT02360228|BG002|Baseline|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
11224457|NCT02360228|BG003|Baseline|Total|Total of all reporting groups
11121147|NCT01705080|BG001|Baseline|B - EnligHTN for Resistant HTN|"Office systolic Blood Pressure ≥140 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121148|NCT01705080|BG002|Baseline|C - EnligHTN for Resistant HTN & CKD|"Office systolic Blood Pressure ≥140 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated ≥15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121149|NCT01705080|BG003|Baseline|Total|Total of all reporting groups
11121150|NCT01705080|FG000|Participant Flow|A - EnligHTN for Severe Resistant HTN|"Office systolic Blood Pressure ≥160 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121151|NCT01705080|FG001|Participant Flow|B - EnligHTN for Resistant HTN|"Office systolic Blood Pressure ≥140 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121152|NCT01705080|FG002|Participant Flow|C - EnligHTN for Resistant HTN & CKD|"Office systolic Blood Pressure ≥140 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated ≥15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121153|NCT01705080|OG000|Outcome|A - EnligHTN for Severe Resistant HTN|"Office systolic Blood Pressure ≥160 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121154|NCT01705080|OG001|Outcome|B - EnligHTN for Resistant HTN|"Office systolic Blood Pressure ≥140 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121155|NCT01705080|OG002|Outcome|C - EnligHTN for Resistant HTN & CKD|"Office systolic Blood Pressure ≥140 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated ≥15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
10878722|NCT00453999|EG000|Reported Event|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
11121156|NCT01705080|EG000|Reported Event|A - EnligHTN for Severe Resistant HTN|"Office systolic Blood Pressure ≥160 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121157|NCT01705080|EG001|Reported Event|B - EnligHTN for Resistant HTN|"Office systolic Blood Pressure ≥140 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121158|NCT01705080|EG002|Reported Event|C - EnligHTN for Resistant HTN & CKD|"Office systolic Blood Pressure ≥140 mmHg~Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.~Participant has an estimated ≥15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula~EnligHTN: Renal artery ablation with EnligHTN system used for all groups"
11121159|NCT01705145|BG000|Baseline|Ivacaftor|"Part A: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.~Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
11121160|NCT01705145|FG000|Participant Flow|Ivacaftor|"Part A: Ivacaftor 50 milligram (mg) (for participants weighing less than [<] 14 kilograms [kg]) or 75 mg (for participants weighing greater than or equal to [>=] 14 kg) every 12 hours (q12h) from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.~Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
11121161|NCT01705145|OG000|Outcome|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
11121162|NCT01705145|OG001|Outcome|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
11121163|NCT01705145|OG002|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
11121164|NCT01705145|OG000|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
11121165|NCT01705145|OG001|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
11121166|NCT01705145|OG002|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
11121167|NCT01705145|OG000|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
11121168|NCT01705145|OG000|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
11121169|NCT01705145|EG000|Reported Event|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
11121170|NCT01705145|EG001|Reported Event|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
11121171|NCT01705145|EG002|Reported Event|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
11121172|NCT01705145|EG003|Reported Event|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
11121173|NCT01705145|EG004|Reported Event|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
11121174|NCT01705145|EG005|Reported Event|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
11121175|NCT01705236|BG000|Baseline|Fingolimod - Longitudinal Assessment|No study drug was provided. Fingolimod was to be prescribed according to local label. The decision to prescribe fingolimod was to be made independent of this study.
11121176|NCT01705236|FG000|Participant Flow|Fingolimod - Longitudinal Assessment|No study drug was provided. Fingolimod was to be prescribed according to local label. The decision to prescribe fingolimod was to be made independent of this study.
11121177|NCT01705236|OG000|Outcome|Fingolimod - Longitudinal Assessment|No study drug was provided. Fingolimod was to be prescribed according to local label. The decision to prescribe fingolimod was to be made independent of this study.
11121178|NCT01705236|EG000|Reported Event|Fingolimod - Longitudinal Assessment|No study drug was provided. Fingolimod was to be prescribed according to local label. The decision to prescribe fingolimod was to be made independent of this study.
11121179|NCT01705288|BG000|Baseline|Control Group (Standard Laparotomy)|"Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.~Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital~intravenous narcotics: given for pain management after surgery per physician orders~standard anesthesia: inhalant or intravenous during surgery"
11121180|NCT01705288|BG001|Baseline|Rapid Recovery Group|"Protocol for rapid recovery laparotomy procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.~Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital~regional anesthesia: given by spinal or epidural infusion~Non-steroidal anti-inflammatory drugs: given for pain management after surgery"
11121181|NCT01705288|BG002|Baseline|Total|Total of all reporting groups
11121182|NCT01705288|FG000|Participant Flow|Control Group (Standard Laparotomy)|"Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.~Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital~intravenous narcotics: given for pain management after surgery per physician orders~standard anesthesia: inhalant or intravenous during surgery"
11224458|NCT02360228|FG000|Participant Flow|tACS (Alpha)|"10Hz transcranial alternating current stimulation (tACS) at the alpha frequency with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
11121183|NCT01705288|FG001|Participant Flow|Rapid Recovery Group|"Protocol for rapid recovery laparotomy procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.~Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital~regional anesthesia: given by spinal or epidural infusion~Non-steroidal anti-inflammatory drugs: given for pain management after surgery"
11121184|NCT01705288|OG000|Outcome|Control Group (Standard Laparotomy)|"Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.~Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital~intravenous narcotics: given for pain management after surgery per physician orders~standard anesthesia: inhalant or intravenous during surgery"
11121185|NCT01705288|OG001|Outcome|Rapid Recovery Group|"Protocol for rapid recovery laparotomy procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.~Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital~regional anesthesia: given by spinal or epidural infusion~Non-steroidal anti-inflammatory drugs: given for pain management after surgery"
11121186|NCT01705288|EG000|Reported Event|Control Group (Standard Laparotomy)|"Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.~Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital~intravenous narcotics: given for pain management after surgery per physician orders~standard anesthesia: inhalant or intravenous during surgery"
11121187|NCT01705288|EG001|Reported Event|Rapid Recovery Group|"Protocol for rapid recovery laparotomy procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.~Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital~regional anesthesia: given by spinal or epidural infusion~Non-steroidal anti-inflammatory drugs: given for pain management after surgery"
11121188|NCT01705496|BG000|Baseline|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
11121189|NCT01705496|FG000|Participant Flow|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
11121190|NCT01705496|OG000|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
11121191|NCT01705496|EG000|Reported Event|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
11121192|NCT01705509|BG000|Baseline|CPET Control / CPET With Ranexa|Enrolled patients will undergo a CPET evaluation. Beta Blockers will be held day prior to and day of CPET. The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg B ID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy. CPET results before and after therapy will undergo a statistical comparison. The initial off treatment CPET measurement will serve as the control to assess changes found during therapy. No medication changes or revascularization procedures will occur during the study.
11121193|NCT01705509|FG000|Participant Flow|CPET Control / CPET With Ranexa|The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy. CPET results before and after therapy will undergo a statistical comparison.
11121194|NCT01705509|OG000|Outcome|Control|"All patients who meet the criteria of ischemia will receive ranolazine after enrollment. The initial CPET will serve as the control. The second CPET after 30-days of therapy will serve as the therapy arm. CPET parameters will be assessed and compared both on and off therapy.~Ranolazine: The intervention will be ranolazine therapy after the initial CPET. The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy. CPET results before and after therapy will undergo a statistical comparison. The initial off treatment CPET measurement will serve as the control to assess changes found during therapy."
11224459|NCT02360228|FG001|Participant Flow|tDCS|2mA transcranial direct current stimulation (tDCS) for 20 minutes twice daily
11121195|NCT01705509|EG000|Reported Event|CPET Control / CPET With Ranexa|The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy.
11121196|NCT01705574|BG000|Baseline|Double-Blind STB to Open-Label STB|"Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks~Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks."
11121197|NCT01705574|BG001|Baseline|Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD|"Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks~Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and either receive open-label GEN 150/150/200/10 mg FDC or open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks."
11121198|NCT01705574|BG002|Baseline|Total|Total of all reporting groups
11121199|NCT01705574|FG000|Participant Flow|Double-Blind STB to Open-Label STB|"Double-Blind (DB) Phase: Stribild® (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) 150/150/200/300 mg fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + Truvada® (TVD; emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) placebo orally once daily with food for 48 weeks~Open-Label Extension (OLE) Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks."
11121200|NCT01705574|FG001|Participant Flow|Double-Blind ATV+RTV+TVD|Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
11121201|NCT01705574|FG002|Participant Flow|Double-Blind ATV+RTV+TVD to Open-Label GEN|"Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks~Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label (OL) Genvoya® (GEN; elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; E/C/F/TAF) 150/150/200/10 mg FDC orally once daily with food for 48 weeks."
11121202|NCT01705574|FG003|Participant Flow|Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD|"Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks~Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks."
11121203|NCT01705574|OG000|Outcome|Double-Blind STB|Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
11121204|NCT01705574|OG001|Outcome|Double-Blind ATV+RTV+TVD|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + TVD (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
11121205|NCT01705574|OG001|Outcome|Double-Blind ATV+RTV+TVD|Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
11121206|NCT01705574|OG000|Outcome|ALL STB|"Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks~Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had option to receive open-label STB FDC orally once daily with food for 48 weeks."
11121207|NCT01705574|OG000|Outcome|Open-Label GEN|Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
11121208|NCT01705574|OG001|Outcome|Open-Label ATV+RTV+TVD|Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
11121209|NCT01705574|OG000|Outcome|Open-Label STB|Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
11121210|NCT01705574|OG001|Outcome|Open-Label GEN|Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
11121211|NCT01705574|OG002|Outcome|Open-Label ATV + RTV + TVD|Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
10878723|NCT00453999|EG001|Reported Event|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
11121212|NCT01705574|EG000|Reported Event|Double-Blind: STB|Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
11121213|NCT01705574|EG001|Reported Event|Double-Blind: ATV+RTV+TVD|Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
11121214|NCT01705574|EG002|Reported Event|DB STB to OL STB|Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
11121215|NCT01705574|EG003|Reported Event|DB ATV+RTV+TVD to OL GEN|Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
11121216|NCT01705574|EG004|Reported Event|DB ATV+RTV+TVD to OL ATV+RTV+TVD|Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC orally once daily with food for 48 weeks.
11121217|NCT01705587|BG000|Baseline|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
11121218|NCT01705587|BG001|Baseline|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
11121219|NCT01705587|BG002|Baseline|Total|Total of all reporting groups
11121220|NCT01705587|FG000|Participant Flow|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
11121221|NCT01705587|FG001|Participant Flow|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
11121222|NCT01705587|OG000|Outcome|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
11121223|NCT01705587|OG001|Outcome|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
11121224|NCT01705587|EG000|Reported Event|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
11121225|NCT01705587|EG001|Reported Event|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
11121226|NCT01705652|BG000|Baseline|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. Minimum of 30 days and maximum of 80 days before surgery. The final dose is taken the day before surgery.
11121227|NCT01705652|BG001|Baseline|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. Minimum of 30 days and maximum of 60 days prior to the start of radiation therapy and then during treatment. The final dose is taken the last day of radiation.
11121228|NCT01705652|BG002|Baseline|Total|Total of all reporting groups
11121229|NCT01705652|FG000|Participant Flow|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
11121230|NCT01705652|FG001|Participant Flow|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
11121231|NCT01705652|OG000|Outcome|Radiation Group|Nexrutine by mouth three times per day for a minimum of 30 days and a maximum of 60 days prior to the start of radiation therapy and during treatment. The final dose will be taken the last day of radiation.
11121232|NCT01705652|OG001|Outcome|Surgery Group|Nexrutine by mouth three times per day prior to surgery for a minimum of 30 days and maximum of 80 days. The final dose is taken the day before surgery.
11121233|NCT01705652|EG000|Reported Event|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
11121234|NCT01705652|EG001|Reported Event|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
11121235|NCT01705691|BG000|Baseline|Arm 1: Paclitaxel Then AC|"Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles~Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks~Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles~Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles"
11121236|NCT01705691|BG001|Baseline|Arm 2: Eribulin Then AC|"Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles~Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles~Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles~Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles"
11121237|NCT01705691|BG002|Baseline|Total|Total of all reporting groups
11121238|NCT01705691|FG000|Participant Flow|Arm 1: Paclitaxel Then AC|"Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles~Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks~Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles~Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles"
11348431|NCT04175262|OG000|Outcome|Sunitinib Following Immune-oncologic Therapy|Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
10878724|NCT00453999|EG002|Reported Event|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
11121239|NCT01705691|FG001|Participant Flow|Arm 2: Eribulin Then AC|"Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles~Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles~Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles~Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles"
11121240|NCT01705691|OG000|Outcome|Arm 1: Paclitaxel Then AC|"Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles~Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks~Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles~Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles"
11121241|NCT01705691|OG001|Outcome|Arm 2: Eribulin Then AC|"Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles~Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles~Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles~Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles"
11121242|NCT01705691|EG000|Reported Event|Arm 1: Paclitaxel Then AC|"Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles~Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks~Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles~Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles"
11121243|NCT01705691|EG001|Reported Event|Arm 2: Eribulin Then AC|"Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles~Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles~Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles~Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles"
11121244|NCT01705717|BG000|Baseline|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
11121245|NCT01705717|BG001|Baseline|HCV - Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
11121246|NCT01705717|BG002|Baseline|Total|Total of all reporting groups
11121247|NCT01705717|FG000|Participant Flow|Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
11121248|NCT01705717|FG001|Participant Flow|Hepatitis C Virus (HCV) - Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
11121249|NCT01705717|OG000|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
11121250|NCT01705717|OG001|Outcome|HCV - Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
11121251|NCT01705717|EG000|Reported Event|All Participants|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC or HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
11121252|NCT01705730|BG000|Baseline|Tocilizumab|Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
11121253|NCT01705730|FG000|Participant Flow|Tocilizumab|Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
11121254|NCT01705730|OG000|Outcome|Tocilizumab|Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
11121255|NCT01705730|EG000|Reported Event|Tocilizumab|Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
11121256|NCT01705964|BG000|Baseline|IM Epinephrine 1:1000|"IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.~IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle."
11121257|NCT01705964|BG001|Baseline|No Intervention|"A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.~No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group."
11121258|NCT01705964|BG002|Baseline|Total|Total of all reporting groups
11121259|NCT01705964|FG000|Participant Flow|IM Epinephrine 1:1000|"IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.~IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle."
11121260|NCT01705964|FG001|Participant Flow|No Intervention|"A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.~No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group."
11224460|NCT02360228|FG002|Participant Flow|Sham Stimulation|Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.
11121261|NCT01705964|OG000|Outcome|IM Epinephrine 1:1000|"IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.~IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle."
11121262|NCT01705964|OG001|Outcome|No Intervention|"A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.~No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group."
11121263|NCT01705964|EG000|Reported Event|IM Epinephrine 1:1000|"IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.~IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle."
11121264|NCT01705964|EG001|Reported Event|No Intervention|"A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.~No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group."
11121265|NCT01706003|BG000|Baseline|In-Office Group|People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches
11121266|NCT01706003|BG001|Baseline|Telemedicine Group|People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
11121267|NCT01706003|BG002|Baseline|Total|Total of all reporting groups
11121268|NCT01706003|FG000|Participant Flow|In-Office Group|People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches
11121269|NCT01706003|FG001|Participant Flow|Telemedicine Group|People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
11121270|NCT01706003|OG000|Outcome|In-Office Group|People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches
11121271|NCT01706003|OG001|Outcome|Telemedicine Group|People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
11121272|NCT01706003|EG000|Reported Event|In-Office Group|People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches
11121273|NCT01706003|EG001|Reported Event|Telemedicine Group|People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
11121274|NCT01706081|BG000|Baseline|Acupuncture|"Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.~Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation."
11121275|NCT01706081|BG001|Baseline|Wait-list|"Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.~Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints."
11121276|NCT01706081|BG002|Baseline|Total|Total of all reporting groups
11121277|NCT01706081|FG000|Participant Flow|Acupuncture|"Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.~Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation."
11121278|NCT01706081|FG001|Participant Flow|Wait-list|"Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.~Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints."
11121279|NCT01706081|OG000|Outcome|Acupuncture|"Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.~Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation."
11121280|NCT01706081|OG001|Outcome|Wait-list|"Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.~Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints."
11224461|NCT02360228|OG000|Outcome|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
11224462|NCT02360228|OG001|Outcome|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
11224463|NCT02360228|OG002|Outcome|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
10878725|NCT00454051|BG000|Baseline|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
11121281|NCT01706081|EG000|Reported Event|Acupuncture|"Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.~Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation."
11121282|NCT01706081|EG001|Reported Event|Wait-list|"Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.~Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints."
11121283|NCT01706146|BG000|Baseline|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
11121284|NCT01706146|FG000|Participant Flow|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
11121285|NCT01706146|OG000|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
11121286|NCT01706146|EG000|Reported Event|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
11121287|NCT01706159|BG000|Baseline|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
11121288|NCT01706159|BG001|Baseline|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
11121289|NCT01706159|BG002|Baseline|Total|Total of all reporting groups
11121290|NCT01706159|FG000|Participant Flow|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
11121291|NCT01706159|FG001|Participant Flow|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
11121292|NCT01706159|OG000|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
11121293|NCT01706159|OG001|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
11121294|NCT01706159|EG000|Reported Event|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
11121295|NCT01706159|EG001|Reported Event|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
11121296|NCT01706198|BG000|Baseline|Usual Care|Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
11121297|NCT01706198|BG001|Baseline|FF/VI|Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
11121298|NCT01706198|BG002|Baseline|Total|Total of all reporting groups
11121299|NCT01706198|FG000|Participant Flow|Usual Care|Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
11121300|NCT01706198|FG001|Participant Flow|FF/VI|Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
11121301|NCT01706198|OG000|Outcome|Usual Care|Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
11121302|NCT01706198|OG001|Outcome|FF/VI|Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
11121303|NCT01706198|EG000|Reported Event|Usual Care|Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
11348432|NCT04175262|EG000|Reported Event|Sunitinib Following Immune-oncologic Therapy|Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
10878726|NCT00454051|BG001|Baseline|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
11121304|NCT01706198|EG001|Reported Event|FF/VI|Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
11121305|NCT01706250|BG000|Baseline|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
11121306|NCT01706250|FG000|Participant Flow|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
11121307|NCT01706250|OG000|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% benzyl peroxide [BPO]) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (the side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
11121308|NCT01706250|OG001|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
11121309|NCT01706250|OG000|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wk. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
11121310|NCT01706250|OG000|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
11121311|NCT01706250|OG001|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
11121312|NCT01706250|OG000|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-weeks (Wk). The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
11121313|NCT01706250|EG000|Reported Event|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
11121314|NCT01706263|BG000|Baseline|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
11224464|NCT02360228|EG000|Reported Event|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
11224465|NCT02360228|EG001|Reported Event|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
11224466|NCT02360228|EG002|Reported Event|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
11348433|NCT04171102|BG000|Baseline|Short Term Post-implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation
11121315|NCT01706263|FG000|Participant Flow|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II™ 2.5 percent (%) benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
11121316|NCT01706263|OG000|Outcome|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
11121317|NCT01706263|OG000|Outcome|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule..
11121318|NCT01706263|EG000|Reported Event|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
11121319|NCT01706328|BG000|Baseline|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
11121320|NCT01706328|BG001|Baseline|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
11121321|NCT01706328|BG002|Baseline|Total|Total of all reporting groups
11121322|NCT01706328|FG000|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo twice a day (one inhalation from a multi-dose powder inhaler [MPI] and one inhalation from a dry powder inhaler [DPI] in the morning; one inhalation from an MPI in the evening). In addition, all participants received supplemental albuterol (salbutamol) (via a metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
11121323|NCT01706328|FG001|Participant Flow|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
11121324|NCT01706328|FG002|Participant Flow|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
11121325|NCT01706328|OG000|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
11121326|NCT01706328|OG001|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
11121327|NCT01706328|EG000|Reported Event|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
11121328|NCT01706328|EG001|Reported Event|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
10878727|NCT00454051|BG002|Baseline|Total|Total of all reporting groups
11121329|NCT01706458|BG000|Baseline|Sipuleucel-T|"Patients receive sipuleucel-T IV on weeks 0, 2, and 4.~sipuleucel-T: Given IV"
11121330|NCT01706458|BG001|Baseline|Sipuleucel-T With DNA Vaccine|"Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.~sipuleucel-T: Given IV~DNA Vaccine: Given ID"
11121331|NCT01706458|BG002|Baseline|Total|Total of all reporting groups
11121332|NCT01706458|FG000|Participant Flow|Sipuleucel-T|"Patients receive sipuleucel-T IV on weeks 0, 2, and 4.~sipuleucel-T: Given IV"
11121333|NCT01706458|FG001|Participant Flow|Sipuleucel-T With DNA Vaccine|"Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.~sipuleucel-T: Given IV~DNA Vaccine: Given ID"
11121334|NCT01706458|OG000|Outcome|Sipuleucel-T|"Patients receive sipuleucel-T IV on weeks 0, 2, and 4.~sipuleucel-T: Given IV"
11121335|NCT01706458|OG001|Outcome|Sipuleucel-T With DNA Vaccine|"Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.~sipuleucel-T: Given IV~DNA Vaccine: Given ID"
11121336|NCT01706458|EG000|Reported Event|Sipuleucel-T|"Patients receive sipuleucel-T IV on weeks 0, 2, and 4.~sipuleucel-T: Given IV"
11121337|NCT01706458|EG001|Reported Event|Sipuleucel-T With DNA Vaccine|"Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.~sipuleucel-T: Given IV~DNA Vaccine: Given ID"
11121338|NCT01706497|BG000|Baseline|Post-cardiac Surgery PICU Admissions|Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
11121339|NCT01706497|FG000|Participant Flow|Post-cardiac Surgery PICU Admissions|Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
11121340|NCT01706497|OG000|Outcome|Post-cardiac Surgery PICU Admissions|Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
11121341|NCT01706497|EG000|Reported Event|Post-cardiac Surgery PICU Admissions|Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
11121342|NCT01706536|BG000|Baseline|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
11121343|NCT01706536|BG001|Baseline|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
11121344|NCT01706536|BG002|Baseline|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
11121345|NCT01706536|BG003|Baseline|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
11121346|NCT01706536|BG004|Baseline|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
11121347|NCT01706536|BG005|Baseline|Total|Total of all reporting groups
11121348|NCT01706536|FG000|Participant Flow|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
11121349|NCT01706536|FG001|Participant Flow|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
11121350|NCT01706536|FG002|Participant Flow|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
11121351|NCT01706536|FG003|Participant Flow|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
11121352|NCT01706536|FG004|Participant Flow|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
11121353|NCT01706536|OG000|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
11121354|NCT01706536|OG001|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
11121355|NCT01706536|OG002|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
11121356|NCT01706536|OG003|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
11121357|NCT01706536|OG004|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
11121358|NCT01706536|OG000|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo AM + Placebo PM"
11121359|NCT01706536|EG000|Reported Event|Placebo|"Placebo AM + Placebo PM~Placebo AM + Placebo PM"
11121360|NCT01706536|EG001|Reported Event|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
11121361|NCT01706536|EG002|Reported Event|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
11121362|NCT01706536|EG003|Reported Event|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
11121363|NCT01706536|EG004|Reported Event|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
11121364|NCT01706549|BG000|Baseline|Postoperative Pain|Observational study on posthysterectomy pain
11121365|NCT01706549|FG000|Participant Flow|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
11121366|NCT01706549|OG000|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
11121367|NCT01706549|EG000|Reported Event|Posthysterectomy Pain|This was an observational study, thus no adverse events were collected.
11121368|NCT01706575|BG000|Baseline|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
11348434|NCT04171102|BG001|Baseline|Mid Term Post-implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation
11121369|NCT01706575|FG000|Participant Flow|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
11121370|NCT01706575|OG000|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
11121371|NCT01706575|EG000|Reported Event|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
11121372|NCT01706588|BG000|Baseline|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121373|NCT01706588|BG001|Baseline|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121374|NCT01706588|BG002|Baseline|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121375|NCT01706588|BG003|Baseline|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121376|NCT01706588|BG004|Baseline|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121377|NCT01706588|BG005|Baseline|Total|Total of all reporting groups
11121378|NCT01706588|FG000|Participant Flow|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121379|NCT01706588|FG001|Participant Flow|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121380|NCT01706588|FG002|Participant Flow|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121381|NCT01706588|FG003|Participant Flow|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121382|NCT01706588|FG004|Participant Flow|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121383|NCT01706588|OG000|Outcome|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121384|NCT01706588|OG001|Outcome|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121385|NCT01706588|OG002|Outcome|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121386|NCT01706588|OG003|Outcome|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121387|NCT01706588|OG004|Outcome|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121388|NCT01706588|EG000|Reported Event|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121389|NCT01706588|EG001|Reported Event|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121390|NCT01706588|EG002|Reported Event|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121391|NCT01706588|EG003|Reported Event|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121392|NCT01706588|EG004|Reported Event|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
11121393|NCT01706666|BG000|Baseline|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
11121394|NCT01706666|BG001|Baseline|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
11121395|NCT01706666|BG002|Baseline|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
11121396|NCT01706666|BG003|Baseline|Total|Total of all reporting groups
11121397|NCT01706666|FG000|Participant Flow|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
11121398|NCT01706666|FG001|Participant Flow|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
11121399|NCT01706666|FG002|Participant Flow|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
11121400|NCT01706666|OG000|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
11121401|NCT01706666|OG001|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
11121402|NCT01706666|OG002|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
11121403|NCT01706666|EG000|Reported Event|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
11121404|NCT01706666|EG001|Reported Event|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
11121405|NCT01706666|EG002|Reported Event|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
11121406|NCT01706770|BG000|Baseline|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
11121407|NCT01706770|BG001|Baseline|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
11121408|NCT01706770|BG002|Baseline|Total|Total of all reporting groups
11121409|NCT01706770|FG000|Participant Flow|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
11121410|NCT01706770|FG001|Participant Flow|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
11121411|NCT01706770|OG000|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
11121412|NCT01706770|OG001|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
11121413|NCT01706770|EG000|Reported Event|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
11121414|NCT01706770|EG001|Reported Event|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
10878728|NCT00454051|FG000|Participant Flow|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
11121415|NCT01706822|BG000|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
11121416|NCT01706822|FG000|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
11121417|NCT01706822|OG000|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
11121418|NCT01706822|EG000|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
11121419|NCT01706926|BG000|Baseline|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
11121420|NCT01706926|BG001|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121421|NCT01706926|BG002|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121422|NCT01706926|BG003|Baseline|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121423|NCT01706926|BG004|Baseline|Total|Total of all reporting groups
11121424|NCT01706926|FG000|Participant Flow|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
11121425|NCT01706926|FG001|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121426|NCT01706926|FG002|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121427|NCT01706926|FG003|Participant Flow|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121428|NCT01706926|OG000|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
11121429|NCT01706926|OG001|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121430|NCT01706926|OG002|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121431|NCT01706926|OG003|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121432|NCT01706926|OG000|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121433|NCT01706926|OG001|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121434|NCT01706926|OG002|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121435|NCT01706926|EG000|Reported Event|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
11121436|NCT01706926|EG001|Reported Event|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121437|NCT01706926|EG002|Reported Event|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121438|NCT01706926|EG003|Reported Event|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11121439|NCT01706952|BG000|Baseline|Cocaine/Adrenaline|"Three cotton neuropatties will be placed in each nostril. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
11121440|NCT01706952|FG000|Participant Flow|Cocaine/Adrenaline|"Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).~Three cotton neuropatties will be placed in each side of the nostril. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose."
11121441|NCT01706952|OG000|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
11121442|NCT01706952|OG001|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
11121443|NCT01706952|EG000|Reported Event|Cocaine|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
11121444|NCT01706952|EG001|Reported Event|Adrenaline|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
11121445|NCT01706965|BG000|Baseline|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
11121446|NCT01706965|BG001|Baseline|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
10878729|NCT00454051|FG001|Participant Flow|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
11121447|NCT01706965|BG002|Baseline|Total|Total of all reporting groups
11121448|NCT01706965|FG000|Participant Flow|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
11121449|NCT01706965|FG001|Participant Flow|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
11121450|NCT01706965|OG000|Outcome|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
11121451|NCT01706965|OG001|Outcome|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
10878730|NCT00454051|OG000|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
10878731|NCT00454051|OG001|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
11121452|NCT01706965|EG000|Reported Event|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
11121453|NCT01706965|EG001|Reported Event|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
11121454|NCT01706978|BG000|Baseline|Soft Tissue Trephination|"Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the bone trephination or soft tissue trephination groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.~Soft Tissue Trephination"
11121455|NCT01706978|BG001|Baseline|Bone Trephination|"Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the bone trephination or soft tissue trephination groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.~Bone Trephination"
11121456|NCT01706978|BG002|Baseline|Total|Total of all reporting groups
11121457|NCT01706978|FG000|Participant Flow|Soft Tissue Trephination|"Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the bone trephination or soft tissue trephination groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.~Soft Tissue Trephination"
11121458|NCT01706978|FG001|Participant Flow|Bone Trephination|"Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the bone trephination or soft tissue trephination groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.~Bone Trephination"
11121459|NCT01706978|OG000|Outcome|Soft Tissue Trephination|"Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the bone trephination or soft tissue trephination groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.~Soft Tissue Trephination"
11121460|NCT01706978|OG001|Outcome|Bone Trephination|"Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the bone trephination or soft tissue trephination groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.~Bone Trephination"
11121461|NCT01706978|EG000|Reported Event|Soft Tissue Trephination|"Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the bone trephination or soft tissue trephination groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.~Soft Tissue Trephination"
11121462|NCT01706978|EG001|Reported Event|Bone Trephination|"Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the bone trephination or soft tissue trephination groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.~Bone Trephination"
11126849|NCT01736085|FG004|Participant Flow|Counseling Plus Voucher|"Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling~Voucher: Subjects will receive a voucher for nicotine patches.~Subjects ra"
11348435|NCT04171102|BG002|Baseline|Long Term Post-implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation
11348436|NCT04171102|BG003|Baseline|Total|Total of all reporting groups
11348437|NCT04171102|FG000|Participant Flow|Neonervegenesis in ProFlor Hernia Implant in the Short Term|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation
11121463|NCT01707004|BG000|Baseline|Decitabine + Bone Marrow Transplant|Pre-transplant Decitabine followed by Bone Marrow Transplant.
11121464|NCT01707004|FG000|Participant Flow|Decitabine + Bone Marrow Transplant|Pre-transplant Decitabine followed by Bone Marrow Transplant.
11121465|NCT01707004|OG000|Outcome|Decitabine + Bone Marrow Transplant|Pre-transplant Decitabine followed by Bone Marrow Transplant.
11121466|NCT01707004|EG000|Reported Event|Decitabine (N=20)|Pre-transplant Decitabine
11121467|NCT01707004|EG001|Reported Event|Transplant (N=17)|Pre-transplant Decitabine followed by Bone Marrow Transplant
11121468|NCT01707030|BG000|Baseline|Intervention: Computer-Based Brief Alcohol Intervention|"Receiving a web-based brief intervention for alcohol problems~Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.~Intervention participants will also receive usual care.~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121469|NCT01707030|BG001|Baseline|Control: Treatment as Usual|"In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121470|NCT01707030|BG002|Baseline|Total|Total of all reporting groups
11121471|NCT01707030|FG000|Participant Flow|Web-Based BAI Arm|"Receiving a web-based brief intervention for alcohol problems~Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms."
11121472|NCT01707030|FG001|Participant Flow|Usual Care Arm|"In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121473|NCT01707030|OG000|Outcome|BAI Arm|"Receiving a web-based brief intervention for alcohol problems~Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121474|NCT01707030|OG001|Outcome|Usual Care|"In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121475|NCT01707030|OG000|Outcome|Intervention: Web Based BAI|"Receiving a web-based brief intervention for alcohol problems~Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121476|NCT01707030|OG001|Outcome|Control: Usual Care|"In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121477|NCT01707030|OG000|Outcome|Web-Based BAI Arm|"Receiving a web-based brief intervention for alcohol problems~Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms."
11121478|NCT01707030|OG001|Outcome|Usual Care Arm|"In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121479|NCT01707030|EG000|Reported Event|Intervention: Web-Based BAI Arm|"Receiving a web-based brief intervention for alcohol problems~Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms."
11121480|NCT01707030|EG001|Reported Event|Control: Usual Care Arm|"In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls~Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems."
11121481|NCT01707043|BG000|Baseline|Taclonex Scalp Suspension First, the Taclonex Ointment|All subjects will use Taclonex Scalp Suspension first to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Ointment for 3 days.There is no washout between products.
11121482|NCT01707043|BG001|Baseline|Taclonex Ointment First Then Taclonex Scalp Suspension|All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.
11121483|NCT01707043|BG002|Baseline|Total|Total of all reporting groups
11121484|NCT01707043|FG000|Participant Flow|Taclonex Scalp Suspension First, Then Taclonex Ointment|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.~Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products."
11121485|NCT01707043|FG001|Participant Flow|Taclonex Ointment First, Then Taclonex Scalp Suspension|All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.
11121486|NCT01707043|OG000|Outcome|Taclonex Scalp Suspension First Then Taclonex Ointment|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.~Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products."
11121487|NCT01707043|OG001|Outcome|Taclonex Ointment First, Then Taclonex Scalp Suspension|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.~Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products."
11121488|NCT01707043|EG000|Reported Event|Taclonex Ointment|All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas In this arm, subject will give a preference rating for Taclonex Ointment
11121489|NCT01707043|EG001|Reported Event|Taclonex Scalp Suspension|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days.~In this arm, subjects will give a preference rating for the Suspension"
11121490|NCT01707095|BG000|Baseline|Bundling of Cords|"The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.~Bundling of cords: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy."
11121491|NCT01707095|BG001|Baseline|Unbundling of Cords|"The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another~Unbundling of cords: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another"
11121492|NCT01707095|BG002|Baseline|Total|Total of all reporting groups
11121493|NCT01707095|FG000|Participant Flow|Bundled|Active electrode cord and camera cord parallel
11121494|NCT01707095|FG001|Participant Flow|Unbundled / Separated|Active electrode cord and camera cord separated
11121495|NCT01707095|OG000|Outcome|Bundled|Active electrode cord and camera cord parallel
11121496|NCT01707095|OG001|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
11121497|NCT01707095|EG000|Reported Event|Bundled|Active electrode cord and camera cord parallel
11121498|NCT01707095|EG001|Reported Event|Unbundled / Separated|Active electrode cord and camera cord separated
11121499|NCT01707108|BG000|Baseline|Dental Implants|"Rehabilitation of missing teeth with Dental Implant (MIS Technologies)~Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants"
11121500|NCT01707108|FG000|Participant Flow|Dental Implants|"Patients with missing teeth that are indicated for rehabilitation with Dental Implants (MIS Technologies) will be recruited. All the implants needed in the surgical area of the recruited patients will be allowed into the study~Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants"
11121501|NCT01707108|OG000|Outcome|Dental Implants|"Rehabilitation of missing teeth with Dental Implant (MIS Technologies)~Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants"
11121502|NCT01707108|OG000|Outcome|Dental Implants|"Patients with missing teeth that are indicated for rehabilitation with Dental Implants (MIS Technologies) will be recruited. All the implants needed in the surgical area of the recruited patients will be allowed into the study~Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants"
11121503|NCT01707108|EG000|Reported Event|Dental Implants|"Rehabilitation of missing teeth with Dental Implant (MIS Technologies)~Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants"
11121504|NCT01707147|BG000|Baseline|Trajenta (Linagliptin) 5 mg|Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
11121505|NCT01707147|FG000|Participant Flow|Trajenta (Linagliptin) 5 mg|Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
11121506|NCT01707147|OG000|Outcome|Trajenta (Linagliptin) 5 mg|Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
11121507|NCT01707147|EG000|Reported Event|Trajenta (Linagliptin) 5 mg|Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
11121508|NCT01707225|BG000|Baseline|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
11121509|NCT01707225|FG000|Participant Flow|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
11121510|NCT01707225|OG000|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
11348438|NCT04171102|FG001|Participant Flow|Neonervegenesis in ProFlor Hernia Implant in the Mid Term|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation
11348439|NCT04171102|FG002|Participant Flow|Neonervegenesis in ProFlor Hernia Implant in the Long Term|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation
11121511|NCT01707225|EG000|Reported Event|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
11121512|NCT01707238|BG000|Baseline|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
11121513|NCT01707238|BG001|Baseline|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
11121514|NCT01707238|BG002|Baseline|Total|Total of all reporting groups
11121515|NCT01707238|FG000|Participant Flow|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
11121516|NCT01707238|FG001|Participant Flow|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
11121517|NCT01707238|OG000|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
11121518|NCT01707238|OG001|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
11121519|NCT01707238|OG000|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.).
11121520|NCT01707238|EG000|Reported Event|Stenfilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
11121521|NCT01707238|EG001|Reported Event|Etafilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
11121522|NCT01707290|BG000|Baseline|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet, q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
11121523|NCT01707290|BG001|Baseline|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
11121524|NCT01707290|BG002|Baseline|Total|Total of all reporting groups
11121525|NCT01707290|FG000|Participant Flow|Ivacaftor Arm|Participants who received Ivacaftor 150 milligram (mg) tablet and/or Placebo matched to Ivacaftor tablet, every 12 hours (q12h) in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
11121526|NCT01707290|FG001|Participant Flow|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
11121527|NCT01707290|OG000|Outcome|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
11121528|NCT01707290|OG000|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
11121529|NCT01707290|OG001|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
11121530|NCT01707290|OG002|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
11121531|NCT01707290|OG000|Outcome|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet, orally, q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
10878732|NCT00454051|EG000|Reported Event|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
11121532|NCT01707290|EG000|Reported Event|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
11348440|NCT04171102|OG000|Outcome|Short Term Post Implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post implantation
11121533|NCT01707290|EG001|Reported Event|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
11121534|NCT01707368|BG000|Baseline|All Eligible Patients|Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
11121535|NCT01707368|FG000|Participant Flow|All Eligible Patients|Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
11121536|NCT01707368|OG000|Outcome|All Eligible Patients|Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
11121537|NCT01707368|EG000|Reported Event|All Eligible Patients|Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
11121538|NCT01707381|BG000|Baseline|All Study Participants|Participants who were randomized to receive either latanoprostene ophthalmic solution 0.024% or timolol maleate 0.5%
11121539|NCT01707381|FG000|Participant Flow|Timolol Maleate Cross Over to BOL-303259X|Participants first recieved timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. Thereafter they received BOL-303259X once in the evening for 4 weeks.
11121540|NCT01707381|FG001|Participant Flow|BOL-303259-X Crossover to Timolol Maleate|Participants first received BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. Thereafter, they received timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
11121541|NCT01707381|OG000|Outcome|Timolol Maleate|"Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.~Timolol maleate: Topical ophthalmic solution"
11121542|NCT01707381|OG001|Outcome|BOL-303259-X|"BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.~BOL-303259-X: Topical ophthalmic solution"
11121543|NCT01707381|EG000|Reported Event|Timolol Maleate|"Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.~Timolol maleate: Topical ophthalmic solution"
11121544|NCT01707381|EG001|Reported Event|BOL-303259-X|"BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.~BOL-303259-X: Topical ophthalmic solution"
11121545|NCT01707420|BG000|Baseline|Placebo|Placebo group
11121546|NCT01707420|BG001|Baseline|Gabapentin|Gabapentin
11121547|NCT01707420|BG002|Baseline|Total|Total of all reporting groups
11121548|NCT01707420|FG000|Participant Flow|Placebo Group|Participants received placebo prior to tonsillectomy
11121549|NCT01707420|FG001|Participant Flow|Gabapentin Group|Participants received gabapentin prior to tonsillectomy
11121550|NCT01707420|OG000|Outcome|Placebo Group|Participants received placebo prior to tonsillectomy
11121551|NCT01707420|OG001|Outcome|Gabapentin Group|Participants received gabapentin prior to tonsillectomy
11121552|NCT01707420|OG000|Outcome|Gabapentin Group|"The gabapentin (treatment) group was given gabapentin, at a single dose of 20 mg/kg, 60 min prior to surgery in liquid form of less than 0.4 mL/kg total volume.~This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid gabapentin given 60 minutes prior to surgery for post-op pain management in healthy pediatric tonsillectomy/adenoidectomy patients."
11121553|NCT01707420|OG001|Outcome|Placebo Group|Participants randomized to the placebo arm will received a single dose of placebo, an identical appearing mixture of sweetener, thickener, and water of equal volume, also given 60 min prior to surgery.
11121554|NCT01707420|EG000|Reported Event|Placebo|Placebo group
11121555|NCT01707420|EG001|Reported Event|Gabapentin|Gabapentin group
11121556|NCT01707472|BG000|Baseline|Simtuzumab in HIV Participants|Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
11121557|NCT01707472|BG001|Baseline|Simtuzumab in HCV Participants|Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
11121558|NCT01707472|BG002|Baseline|Simtuzumab in HIV/HCV Co-Infected Participants|Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
11121559|NCT01707472|BG003|Baseline|Total|Total of all reporting groups
11121560|NCT01707472|FG000|Participant Flow|Simtuzumab in HIV Participants|Participants with human immunodeficiency virus (HIV) received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
11121561|NCT01707472|FG001|Participant Flow|Simtuzumab in HCV Participants|Participants with hepatitis C virus (HCV) received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
11121562|NCT01707472|FG002|Participant Flow|Simtuzumab in HIV/HCV Co-Infected Participants|Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
11121563|NCT01707472|OG000|Outcome|Simtuzumab in HIV Participants|Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
11121564|NCT01707472|OG001|Outcome|Simtuzumab in HCV Participants|Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
11121565|NCT01707472|OG002|Outcome|Simtuzumab in HIV/HCV Co-Infected Participants|Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
11121566|NCT01707472|EG000|Reported Event|Simtuzumab in HIV Participants|Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
11121567|NCT01707472|EG001|Reported Event|Simtuzumab in HCV Participants|Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
11121568|NCT01707472|EG002|Reported Event|Simtuzumab in HIV/HCV Co-Infected Participants|Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
11121569|NCT01707654|BG000|Baseline|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
11121570|NCT01707654|FG000|Participant Flow|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
11121571|NCT01707654|OG000|Outcome|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
11121572|NCT01707654|EG000|Reported Event|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
11121573|NCT01707667|BG000|Baseline|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
11121574|NCT01707667|BG001|Baseline|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
11121575|NCT01707667|BG002|Baseline|Total|Total of all reporting groups
11121576|NCT01707667|FG000|Participant Flow|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
11121577|NCT01707667|FG001|Participant Flow|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
11121578|NCT01707667|OG000|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
11121579|NCT01707667|OG001|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
11121580|NCT01707667|EG000|Reported Event|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
11121581|NCT01707667|EG001|Reported Event|Polyethylene Glycol|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
11121582|NCT01707693|BG000|Baseline|Lifestyle Physical Activity Intervention|"the women will be randomized to either the LPA Intervention (n=60) or Information/Attention Comparison (I/A, n=60) groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer & LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.~Lifestyle Physical Activity Intervention: Behavioral counseling"
11121583|NCT01707693|BG001|Baseline|Information/Attention Comparison|"the women will be randomized to either the LPA Intervention (n=60) or Information/Attention Comparison (I/A, n=60) groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer & LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.~Information / Attention Comparison: Information and attention comparison"
11121584|NCT01707693|BG002|Baseline|Total|Total of all reporting groups
11121585|NCT01707693|FG000|Participant Flow|Physical Activity Motivational Interviewing Counseling INTERV|"Received educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.~This is the active intervention group"
11121586|NCT01707693|FG001|Participant Flow|Information/Attention Without Counseling CONTROL|"Received informational/educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of overall health (without counseling).~This is the Control Group"
11121587|NCT01707693|OG000|Outcome|Physical Activity Motivational Interviewing Counseling INTERV|"Received educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.~This is the active intervention group"
11121588|NCT01707693|OG001|Outcome|Information/Attention Without Counseling CONTROL|"Received informational/educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of overall health (without counseling).~This is the Control Group"
11121589|NCT01707693|OG001|Outcome|Information/Attention Without Counseling CONTROL|"Information/Attention without Counseling CONTROL Received informational/educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of overall health (without counseling).~This is the Control Group"
11121590|NCT01707693|EG000|Reported Event|Physical Activitiy Motiviational Interviewing Counseling INTER|"Received educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency.~This is the active intervention group"
11121591|NCT01707693|EG001|Reported Event|Information/Attention Without Counseling CONTROL|"Received informational/educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of overall health (without counseling).~This is the Control Group"
11121592|NCT01707992|BG000|Baseline|Placebo-Controlled Phase: Placebo|Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.
11121593|NCT01707992|BG001|Baseline|Placebo-Controlled Phase: Laquinimod 0.6 mg|Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
11121594|NCT01707992|BG002|Baseline|Placebo-Controlled Phase: Laquinimod 1.2 mg|Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.
11121595|NCT01707992|BG003|Baseline|Total|Total of all reporting groups
11121596|NCT01707992|FG000|Participant Flow|Placebo-Controlled Phase: Placebo|Participants received 2 capsules of placebo (matched to laquinimod 0.6 milligrams [mg]) once daily orally for up to 24 months.
11121597|NCT01707992|FG001|Participant Flow|Placebo-Controlled Phase: Laquinimod 0.6 mg|Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
11121598|NCT01707992|FG002|Participant Flow|Placebo-Controlled Phase: Laquinimod 1.2 mg|Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.
11121599|NCT01707992|FG003|Participant Flow|Active Treatment Phase: Laquinimod 0.6 mg|Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.
11121600|NCT01707992|FG004|Participant Flow|Active Treatment Phase: Laquinimod 1.2 mg|Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.
11121601|NCT01707992|FG005|Participant Flow|Active Treatment Phase: Off Drug|Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 continued to the active-treatment phase off drug for 24 months.
11121602|NCT01707992|OG000|Outcome|Placebo-Controlled Phase: Placebo|Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.
11121603|NCT01707992|OG001|Outcome|Placebo-Controlled Phase: Laquinimod 0.6 mg|Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
11121604|NCT01707992|OG002|Outcome|Placebo-Controlled Phase: Laquinimod 1.2 mg|Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.
11121605|NCT01707992|OG000|Outcome|Active Treatment Phase: Laquinimod 0.6 mg|Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.
11121606|NCT01707992|OG001|Outcome|Active Treatment Phase: Laquinimod 1.2 mg|Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.
11121607|NCT01707992|EG000|Reported Event|Placebo-Controlled Phase: Laquinimod 0.6 mg|Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
11121608|NCT01707992|EG001|Reported Event|Placebo-Controlled Phase: Laquinimod 1.2 mg|Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.
11121609|NCT01707992|EG002|Reported Event|Placebo-Controlled Phase: Placebo|Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.
11121610|NCT01707992|EG003|Reported Event|Active Treatment Phase: Early Laquinimod 0.6 mg|Participants who completed the placebo-controlled phase on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.
11121611|NCT01707992|EG004|Reported Event|Active Treatment Phase: Early Laquinimod 1.2 mg|Participants who completed the placebo-controlled phase on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.
11121612|NCT01707992|EG005|Reported Event|Active Treatment Phase: Off Drug|Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016, continued to the active-treatment phase off drug for 24 months.
10878733|NCT00454051|EG001|Reported Event|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
11348441|NCT04171102|OG001|Outcome|Mid Term Post Implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post implantation
10878734|NCT00454116|BG000|Baseline|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
11121613|NCT01707992|EG006|Reported Event|Active Treatment Phase: From Placebo to Laquinimod 0.6 mg|Participants who completed the placebo-controlled phase on placebo treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.
11121614|NCT01707992|EG007|Reported Event|Active Treatment Phase: From Placebo to Laquinimod 1.2 mg|Participants who completed the placebo-controlled phase on placebo treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.
11121615|NCT01708122|BG000|Baseline|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
11121616|NCT01708122|BG001|Baseline|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
11121617|NCT01708122|BG002|Baseline|Total|Total of all reporting groups
11121618|NCT01708122|FG000|Participant Flow|Placebo|"Subjects will receive 0.1 mL of intranasal saline as placebo.~saline: Sodium Chloride 0.9% intranasal spray"
11121619|NCT01708122|FG001|Participant Flow|Fentanyl|Subjects receiving either 50mcg or 100mcg
11121620|NCT01708122|OG000|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
11121621|NCT01708122|OG001|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
11121622|NCT01708122|EG000|Reported Event|Fentanyl|"Subjects receiving either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)~Fentanyl: 100 mcg in 1 mL intranasal spray"
11121623|NCT01708122|EG001|Reported Event|Placebo|"Subjects receiving either 0.5mL or 1 mL intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
11348442|NCT04171102|OG002|Outcome|Long Term Post-implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post implantation
11121624|NCT01708161|BG000|Baseline|BYL 200mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121625|NCT01708161|BG001|Baseline|BYL 300mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121626|NCT01708161|BG002|Baseline|BYL 350mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121627|NCT01708161|BG003|Baseline|HR+BC - Phase II|Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breast carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg.
11121628|NCT01708161|BG004|Baseline|Ovarian - Phase II|Patients with PIK3CA mutated or amplified ovarian cancer were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg
11121629|NCT01708161|BG005|Baseline|Non-HR+BC/Ovarian - Phase II|Patients with other than Breast and Ovarian cancer treated in the phase II part
11121630|NCT01708161|BG006|Baseline|Total|Total of all reporting groups
11121631|NCT01708161|FG000|Participant Flow|BYL 200mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121632|NCT01708161|FG001|Participant Flow|BYL 300mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121633|NCT01708161|FG002|Participant Flow|BYL 350mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121634|NCT01708161|FG003|Participant Flow|HR+BC - Phase II|Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breast carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg.
11121635|NCT01708161|FG004|Participant Flow|Ovarian - Phase II|Patients with PIK3CA mutated or amplified ovarian cancer were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg
10878735|NCT00454116|BG001|Baseline|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
11121636|NCT01708161|FG005|Participant Flow|Non-HR+BC/Ovarian - Phase II|Patients with other than Breast and Ovarian cancer treated in the phase II part
11121637|NCT01708161|OG000|Outcome|BYL 200mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121638|NCT01708161|OG001|Outcome|BYL 300mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121639|NCT01708161|OG002|Outcome|BYL 350mg + AMG 12mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121640|NCT01708161|OG000|Outcome|HR+BC - Phase II|Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breast carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg.
11121641|NCT01708161|OG001|Outcome|Ovarian - Phase II|Patients with PIK3CA mutated or amplified ovarian cancer were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg
11121642|NCT01708161|OG002|Outcome|All Patients - Phase|"The total column All patients includes a patient with non-HR+BC and non-Ovarian cancer treated in the Phase II part."
11121643|NCT01708161|OG002|Outcome|All Patients - Phase II|"The total column All patients includes a patient with non-HR+BC and non-Ovarian cancer treated in the Phase II part."
11121644|NCT01708161|EG000|Reported Event|BYL 200mg + AMG 12 mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121645|NCT01708161|EG001|Reported Event|BYL 300mg + AMG 12 mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121646|NCT01708161|EG002|Reported Event|BYL 350mg + AMG 12 mg/kg|BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors
11121647|NCT01708161|EG003|Reported Event|HR + BC - Phase II|Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breat carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg
11121648|NCT01708161|EG004|Reported Event|Ovarian - Phase II|Patients with other than Breast and Ovarian cancer treated in the phase II
11121649|NCT01708174|BG000|Baseline|Sonidegib (LDE225) Children|500 mg/m2 orally
11121650|NCT01708174|BG001|Baseline|Sonidegib (LDE225) Adults|600 mg orally
11121651|NCT01708174|BG002|Baseline|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
11121652|NCT01708174|BG003|Baseline|Total|Total of all reporting groups
11121653|NCT01708174|FG000|Participant Flow|Sonidegib (LDE225) Children|500 mg/m2 orally
11121654|NCT01708174|FG001|Participant Flow|Sonidegib (LDE225) Adults|600 mg orally
11121655|NCT01708174|FG002|Participant Flow|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
10878736|NCT00454116|BG002|Baseline|Placebo Plus FOLFIRI|placebo plus FOLFIRI
10878737|NCT00454116|BG003|Baseline|Total|Total of all reporting groups
10878738|NCT00454116|FG000|Participant Flow|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
10878739|NCT00454116|FG001|Participant Flow|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
11121656|NCT01708174|OG000|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
11121657|NCT01708174|OG001|Outcome|Sonidegib (LDE225) Adults|600 mg orally
11121658|NCT01708174|OG002|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
11121659|NCT01708174|EG000|Reported Event|Sonidegib (LDE225) Children|500 mg/m2 orally
11121660|NCT01708174|EG001|Reported Event|Sonidegib (LDE225) Adults|600 mg orally
11121661|NCT01708174|EG002|Reported Event|Sonidegib (Total)|Sonidegib (Total)
11121662|NCT01708174|EG003|Reported Event|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
11121663|NCT01708187|BG000|Baseline|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
11121664|NCT01708187|BG001|Baseline|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
11121665|NCT01708187|BG002|Baseline|Total|Total of all reporting groups
11121666|NCT01708187|FG000|Participant Flow|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
11121667|NCT01708187|FG001|Participant Flow|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
11121668|NCT01708187|OG000|Outcome|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
11121669|NCT01708187|OG001|Outcome|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
11121670|NCT01708187|EG000|Reported Event|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
11121671|NCT01708187|EG001|Reported Event|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
11121672|NCT01708213|BG000|Baseline|Dermal Filler - Aline HA|"Single armed study~Aline HA: Implantable dermal filler"
11121673|NCT01708213|FG000|Participant Flow|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
11121674|NCT01708213|OG000|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
11121675|NCT01708213|EG000|Reported Event|Dermal Filler - Aline HA|To evaluate the safety and performance of Aline HA to treat mild to severe wrinkles in adult subjects
11121676|NCT01708278|BG000|Baseline|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121677|NCT01708278|BG001|Baseline|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121678|NCT01708278|BG002|Baseline|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121679|NCT01708278|BG003|Baseline|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121680|NCT01708278|BG004|Baseline|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121681|NCT01708278|BG005|Baseline|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121682|NCT01708278|BG006|Baseline|Total|Total of all reporting groups
11121683|NCT01708278|FG000|Participant Flow|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121684|NCT01708278|FG001|Participant Flow|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121685|NCT01708278|FG002|Participant Flow|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121686|NCT01708278|FG003|Participant Flow|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121687|NCT01708278|FG004|Participant Flow|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121688|NCT01708278|FG005|Participant Flow|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121689|NCT01708278|OG000|Outcome|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121690|NCT01708278|OG001|Outcome|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11348443|NCT04171102|EG000|Reported Event|Short Term Post-implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation
10878740|NCT00454116|FG002|Participant Flow|Placebo Plus FOLFIRI|placebo plus FOLFIRI
10878741|NCT00454116|OG000|Outcome|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
10878742|NCT00454116|OG001|Outcome|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
11121691|NCT01708278|OG002|Outcome|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121692|NCT01708278|OG003|Outcome|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121693|NCT01708278|OG004|Outcome|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121694|NCT01708278|OG005|Outcome|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121695|NCT01708278|EG000|Reported Event|Sugar Chew-Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121696|NCT01708278|EG001|Reported Event|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121697|NCT01708278|EG002|Reported Event|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121698|NCT01708278|EG003|Reported Event|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
11121699|NCT01708278|EG004|Reported Event|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121700|NCT01708278|EG005|Reported Event|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
11121701|NCT01708291|BG000|Baseline|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
11121702|NCT01708291|BG001|Baseline|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
11121703|NCT01708291|BG002|Baseline|Total|Total of all reporting groups
11121704|NCT01708291|FG000|Participant Flow|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
11121705|NCT01708291|FG001|Participant Flow|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
11121706|NCT01708291|OG000|Outcome|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
11121707|NCT01708291|OG001|Outcome|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
11121708|NCT01708291|EG000|Reported Event|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
11121709|NCT01708291|EG001|Reported Event|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
11121710|NCT01708317|BG000|Baseline|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
11121711|NCT01708317|FG000|Participant Flow|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
11121712|NCT01708317|OG000|Outcome|Historical Control|Participants seen in SLCH ED in 2010 that met ACASI inclusion/exclusion criteria
11121713|NCT01708317|OG001|Outcome|Initial Education Period|Participants seen in SLCH ED Jan 1 - April 17 2011 during initial education period that met ACASI inclusion/exclusion criteria
11121714|NCT01708317|OG002|Outcome|ACASI + Education|Participants seen in SLCH ED April 18 - Dec 20 2011 that met ACASI inclusion/exclusion criteria. During this period education continued and ACASI enrollment was conducted.
11121715|NCT01708317|OG003|Outcome|Final Education Period|Participants seen in SLCH ED Dec 21, 2011 through March 2012 that met ACASI inclusion/exclusion criteria. During this period education continued and no ACASI enrollment was conducted.
11121716|NCT01708317|EG000|Reported Event|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
11121717|NCT01708525|BG000|Baseline|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
11121718|NCT01708525|FG000|Participant Flow|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
11121719|NCT01708525|OG000|Outcome|Untreated Tissue|Heavy water labeled tissue NOT receiving an Ultherapy® Treatment
11121720|NCT01708525|OG001|Outcome|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera® System Treatment: Focused ultrasound energy delivered below the surface of the skin"
11121721|NCT01708525|EG000|Reported Event|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
11121722|NCT01708590|BG000|Baseline|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.~210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)~placebo: Placebo administered subcutaneous (SC)"
11121723|NCT01708590|BG001|Baseline|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.~140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)~placebo: Placebo administered subcutaneous (SC)"
11121724|NCT01708590|BG002|Baseline|Placebo|"Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)~placebo: Placebo administered subcutaneous (SC)"
11121725|NCT01708590|BG003|Baseline|Total|Total of all reporting groups
11121726|NCT01708590|FG000|Participant Flow|Induction Phase: 210 mg Brodalumab|Administered by subcutaneous (SC) injection until week 12. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)
11121727|NCT01708590|FG001|Participant Flow|Induction Phase: 140 mg Brodalumab|Administered by subcutaneous (SC) injection until week 12. 140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)
11121728|NCT01708590|FG002|Participant Flow|Induction Phase: Placebo|Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)
11121729|NCT01708590|FG003|Participant Flow|Withdrawal Phase: Placebo (140mg)|Administered SC injection Week 12 - Week 52
11121730|NCT01708590|FG004|Participant Flow|Withdrawal Phase: 140mg Brodalumab Q2W|Administered SC injection, Week 12 - Week 52
11121731|NCT01708590|FG005|Participant Flow|Withdrawal Phase: Placebo (210mg)|Administered SC, Week 12 - Week 52
10878743|NCT00454116|OG002|Outcome|Placebo Plus FOLFIRI|placebo plus FOLFIRI
11121732|NCT01708590|FG006|Participant Flow|Withdrawl Phase: 210mg Brodalumab Q2W|Administered SC injection, Week 12- Week 16
11121733|NCT01708590|OG000|Outcome|Induction Phase: 210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.~210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)~placebo: Placebo administered subcutaneous (SC)"
11121734|NCT01708590|OG001|Outcome|Induction Phase: 140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.~140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)~placebo: Placebo administered subcutaneous (SC)"
11121735|NCT01708590|OG002|Outcome|Induction Phase: Placebo|Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)
11121736|NCT01708590|OG002|Outcome|Induction Phase: Placebo|"Administered by SC injection until week 12.~placebo: Placebo administered subcutaneous (SC)"
11121737|NCT01708590|OG000|Outcome|Withdrawal Phase: Placebo (140mg)|Administered SC injection Week 12 - Week 52
11121738|NCT01708590|OG001|Outcome|Withdrawal Phase: 140mg Brodalumab Q2W|Administered SC injection, Week 12 - Week 52
11121739|NCT01708590|OG002|Outcome|Withdrawal Phase: Placebo (210mg)|Administered SC, Week 12 - Week 52
11121740|NCT01708590|OG003|Outcome|Withdrawl Phase: 210mg Brodalumab Q2W|Administered SC injection, Week 12- Week 16
11121741|NCT01708590|EG000|Reported Event|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.~210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)~placebo: Placebo administered subcutaneous (SC)"
11121742|NCT01708590|EG001|Reported Event|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.~140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)~placebo: Placebo administered subcutaneous (SC)"
11121743|NCT01708590|EG002|Reported Event|Placebo|"Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)~placebo: Placebo administered subcutaneous (SC)"
11121744|NCT01708603|BG000|Baseline|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~210 mg brodalumab: 210 mg brodalumab administered SC"
11121745|NCT01708603|BG001|Baseline|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~140 mg brodalumab: 140 mg brodalumab administered SC"
11121746|NCT01708603|BG002|Baseline|Ustekinumab|"Administered by subcutaneous (SC) injection per the labeled dosing regimen.~ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen."
11121747|NCT01708603|BG003|Baseline|Placebo|"Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered SC~placebo: Placebo administered SC"
11121748|NCT01708603|BG004|Baseline|Total|Total of all reporting groups
11121749|NCT01708603|FG000|Participant Flow|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~210 mg brodalumab: 210 mg brodalumab administered SC"
11121750|NCT01708603|FG001|Participant Flow|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~140 mg brodalumab: 140 mg brodalumab administered SC"
11121751|NCT01708603|FG002|Participant Flow|Ustekinumab|"Administered by subcutaneous (SC) injection per the labeled dosing regimen.~ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen."
11121752|NCT01708603|FG003|Participant Flow|Placebo|"Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered SC~placebo: Placebo administered SC"
11121753|NCT01708603|OG000|Outcome|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~210 mg brodalumab: 210 mg brodalumab administered SC"
11121754|NCT01708603|OG001|Outcome|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~140 mg brodalumab: 140 mg brodalumab administered SC"
11121755|NCT01708603|OG002|Outcome|Placebo|"Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered SC~placebo: Placebo administered SC"
11121756|NCT01708603|OG003|Outcome|Ustekinumab|Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
11121757|NCT01708603|OG002|Outcome|Placebo|Brodalumab Placebo
11121758|NCT01708603|OG000|Outcome|Brodalumab 210mg|Brodalumab 210mg Q2W
11121759|NCT01708603|OG001|Outcome|Brodalumab 140mg|Brodalumab 140mg Q2W
11121760|NCT01708603|OG002|Outcome|Placebo|Brodalumab placebo
11121761|NCT01708603|OG003|Outcome|Ustekinumab|Ustekinumab administered in a dose of 45mg in a prefilled syringe of 0.5mL
11121762|NCT01708603|EG000|Reported Event|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~210 mg brodalumab: 210 mg brodalumab administered SC"
11121763|NCT01708603|EG001|Reported Event|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~140 mg brodalumab: 140 mg brodalumab administered SC"
11121764|NCT01708603|EG002|Reported Event|Ustekinumab|"Administered by subcutaneous (SC) injection per the labeled dosing regimen.~ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen."
11121765|NCT01708603|EG003|Reported Event|Placebo|"Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered SC~placebo: Placebo administered SC"
11121766|NCT01708629|BG000|Baseline|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~210 mg brodalumab: 210 mg brodalumab administered SC"
11121767|NCT01708629|BG001|Baseline|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~140 mg brodalumab: 140 mg brodalumab administered SC"
11121768|NCT01708629|BG002|Baseline|Ustekinumab|"Administered by subcutaneous (SC) injection per the labeled dosing regimen.~ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen."
11121769|NCT01708629|BG003|Baseline|Placebo|"Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered SC~placebo: placebo administered SC"
11121770|NCT01708629|BG004|Baseline|Total|Total of all reporting groups
11121771|NCT01708629|FG000|Participant Flow|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~210 mg brodalumab: 210 mg brodalumab administered SC"
11121772|NCT01708629|FG001|Participant Flow|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~140 mg brodalumab: 140 mg brodalumab administered SC"
11121773|NCT01708629|FG002|Participant Flow|Ustekinumab|"Administered by subcutaneous (SC) injection per the labeled dosing regimen.~ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen."
11121774|NCT01708629|FG003|Participant Flow|Placebo|"Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered SC~placebo: placebo administered SC"
11121775|NCT01708629|OG000|Outcome|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~210 mg brodalumab: 210 mg brodalumab administered SC"
11121776|NCT01708629|OG001|Outcome|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~140 mg brodalumab: 140 mg brodalumab administered SC"
11121777|NCT01708629|OG002|Outcome|Placebo|"Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered SC~placebo: placebo administered SC"
11121778|NCT01708629|OG003|Outcome|Ustekinumab|Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
11121779|NCT01708629|EG000|Reported Event|210 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~210 mg brodalumab: 210 mg brodalumab administered SC"
11121780|NCT01708629|EG001|Reported Event|140 mg Brodalumab|"Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.~140 mg brodalumab: 140 mg brodalumab administered SC"
11121781|NCT01708629|EG002|Reported Event|Placebo|"Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.~210 mg brodalumab: 210 mg brodalumab administered SC~placebo: placebo administered SC"
11121782|NCT01708629|EG003|Reported Event|Ustekinumab|Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
11121783|NCT01708902|BG000|Baseline|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
11121784|NCT01708902|BG001|Baseline|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
11121785|NCT01708902|BG002|Baseline|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
11121786|NCT01708902|BG003|Baseline|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
11121787|NCT01708902|BG004|Baseline|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
11121788|NCT01708902|BG005|Baseline|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
11121789|NCT01708902|BG006|Baseline|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
11121790|NCT01708902|BG007|Baseline|Total|Total of all reporting groups
11121791|NCT01708902|FG000|Participant Flow|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
11121792|NCT01708902|FG001|Participant Flow|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.
11121793|NCT01708902|FG002|Participant Flow|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.
11121794|NCT01708902|FG003|Participant Flow|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
11121795|NCT01708902|FG004|Participant Flow|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
11121796|NCT01708902|FG005|Participant Flow|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.~(Data up to week 12)"
11121797|NCT01708902|FG006|Participant Flow|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
11121798|NCT01708902|OG000|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
11121799|NCT01708902|OG001|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
11121800|NCT01708902|OG002|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
11121801|NCT01708902|OG003|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
11121802|NCT01708902|OG004|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
11121803|NCT01708902|OG000|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
11121804|NCT01708902|OG001|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
11121805|NCT01708902|EG000|Reported Event|Main: Linagliptin 5mg QD|Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.
11121806|NCT01708902|EG001|Reported Event|Main: Metformin 500mg BID|Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.
11121807|NCT01708902|EG002|Reported Event|Main: Metformin 1000mg BID|Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.
11121808|NCT01708902|EG003|Reported Event|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
11121809|NCT01708902|EG004|Reported Event|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
11121810|NCT01708902|EG005|Reported Event|APG: Linagliptin 5mg QD up to Week 12|"Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
11121811|NCT01708902|EG006|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
11121812|NCT01708902|EG007|Reported Event|APG: Linagliptin 5mg After Week 12|Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24
11121813|NCT01708902|EG008|Reported Event|APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12|Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.
11121814|NCT01708902|EG009|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~Data from week 12 to week 24."
11121815|NCT01708915|BG000|Baseline|Placebo|Patients treated with placebo ointment
11121816|NCT01708915|BG001|Baseline|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
11121817|NCT01708915|BG002|Baseline|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
11121818|NCT01708915|BG003|Baseline|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
11121819|NCT01708915|BG004|Baseline|Total|Total of all reporting groups
11121820|NCT01708915|FG000|Participant Flow|Placebo|Patients treated with placebo ointment
11121821|NCT01708915|FG001|Participant Flow|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
11121822|NCT01708915|FG002|Participant Flow|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
11121823|NCT01708915|FG003|Participant Flow|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
11121824|NCT01708915|OG000|Outcome|Placebo|Patients treated with placebo ointment
11121825|NCT01708915|OG001|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
11121826|NCT01708915|OG002|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
11121827|NCT01708915|OG003|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
11121828|NCT01708915|EG000|Reported Event|Placebo|Patients treated with placebo ointment
11121829|NCT01708915|EG001|Reported Event|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
11121830|NCT01708915|EG002|Reported Event|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
11121831|NCT01708915|EG003|Reported Event|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide alone
11121832|NCT01708967|BG000|Baseline|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)"
11121833|NCT01708967|BG001|Baseline|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter"
11121834|NCT01708967|BG002|Baseline|Total|Total of all reporting groups
11121835|NCT01708967|FG000|Participant Flow|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
11121836|NCT01708967|FG001|Participant Flow|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
11121837|NCT01708967|OG000|Outcome|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
11121838|NCT01708967|OG001|Outcome|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
11224520|NCT02360488|BG000|Baseline|Telerehabilitation Therapy|"The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.~Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions."
11121839|NCT01708967|EG000|Reported Event|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
11121840|NCT01708967|EG001|Reported Event|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
11121841|NCT01709032|BG000|Baseline|Deferasirox and Deferiprone|Deferasirox and deferiprone
11121842|NCT01709032|FG000|Participant Flow|Deferasirox and Deferiprone|Deferasirox and deferiprone
11121843|NCT01709032|OG000|Outcome|Deferasirox and Deferiprone|Deferasirox and deferiprone
11121844|NCT01709032|OG000|Outcome|Deferasirox and Deferiprone Combination Chelation|Deferasirox and deferiprone
11121845|NCT01709032|EG000|Reported Event|Deferasirox and Deferiprone|Deferasirox and deferiprone
11121846|NCT01709084|BG000|Baseline|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
11121847|NCT01709084|BG001|Baseline|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
11121848|NCT01709084|BG002|Baseline|Total|Total of all reporting groups
11121849|NCT01709084|FG000|Participant Flow|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
11121850|NCT01709084|FG001|Participant Flow|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
11121851|NCT01709084|OG000|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
11121852|NCT01709084|OG001|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
11121853|NCT01709084|EG000|Reported Event|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
11121854|NCT01709084|EG001|Reported Event|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
11121855|NCT01709110|BG000|Baseline|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
11121856|NCT01709110|BG001|Baseline|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
11121857|NCT01709110|BG002|Baseline|Total|Total of all reporting groups
11121858|NCT01709110|FG000|Participant Flow|Teriparatide|"Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
11121859|NCT01709110|FG001|Participant Flow|Risedronate|"Risedronate 35 milligram (mg) administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
11121860|NCT01709110|OG000|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
11121861|NCT01709110|OG001|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
11121862|NCT01709110|EG000|Reported Event|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
11121863|NCT01709110|EG001|Reported Event|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
11121864|NCT01709149|BG000|Baseline|Did Not Complete Open-label Lead-in Treatment|Tirasemtiv 125 mg oral capsules administered twice daily for 7 days. This group started open-label treatment but discontinued early and did not receive double-blind treatment.
11121865|NCT01709149|BG001|Baseline|Double-blind Treatment: Placebo|Placebo oral capsules administered twice daily for a total of 12 weeks of double-blind dosing.
11121866|NCT01709149|BG002|Baseline|Double-blind Treatment: Tirasemtiv|Tirasemtiv 125 mg oral capsules administered twice daily, which was up- or down-titrated over 3 to 4 weeks to the patient's maximum tolerated dose (MTD) to a maximum of 250 mg twice daily. Patients then remained at their MTD for an additional 9 weeks, for a total of 12 weeks of double-blind dosing.
11348444|NCT04171102|EG001|Reported Event|Mid Term Post-implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation
11121867|NCT01709149|BG003|Baseline|Total|Total of all reporting groups
11121868|NCT01709149|FG000|Participant Flow|Open-label lead-in Treatment: Tirasemtiv|Tirasemtiv 125 mg oral capsules administered twice daily for 7 days prior to randomization to the Double-blind treatment period.
11121869|NCT01709149|FG001|Participant Flow|Double-blind Treatment: Placebo|Placebo oral capsules administered twice daily for a total of 12 weeks of double-blind dosing.
11121870|NCT01709149|FG002|Participant Flow|Double-blind Treatment: Tirasemtiv|Tirasemtiv 125 mg oral capsules administered twice daily. Minimum dose was 125 mg bid and patients were up- or down-titrated over 3 to 4 weeks to the patient's maximum tolerated dose (MTD) to a maximum of 250 mg twice daily. Patients then remained at their MTD for an additional 9 weeks, for a total of 12 weeks of double-blind dosing.
11121871|NCT01709149|OG000|Outcome|Placebo|Placebo oral capsules administered twice daily for a total of 12 weeks of double-blind dosing.
11121872|NCT01709149|OG001|Outcome|Tirasemtiv|Tirasemtiv 125 mg oral capsules administered twice daily, which was up- or down-titrated over 3 to 4 weeks to the patient's maximum tolerated dose (MTD) to a maximum of 250 mg twice daily. Patients then remained at their MTD for an additional 9 weeks, for a total of 12 weeks of double-blind dosing.
11121873|NCT01709149|EG000|Reported Event|Open-label lead-in Treatment: Tirasemtiv|Tirasemtiv 125 mg oral capsules administered twice daily for 7 days prior to randomization to the Double-blind treatment period.
11121874|NCT01709149|EG001|Reported Event|Double-blind Treatment: Placebo|Placebo oral capsules administered twice daily for a total of 12 weeks of double-blind dosing.
11121875|NCT01709149|EG002|Reported Event|Double-blind Treatment: Tirasemtiv|Tirasemtiv 125 mg oral capsules administered twice daily, which was up- or down-titrated over 3 to 4 weeks to the patient's maximum tolerated dose (MTD) to a maximum of 250 mg twice daily. Patients then remained at their MTD for an additional 9 weeks, for a total of 12 weeks of double-blind dosing.
11121876|NCT01709162|BG000|Baseline|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
11121877|NCT01709162|BG001|Baseline|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
11121878|NCT01709162|BG002|Baseline|Total|Total of all reporting groups
11121879|NCT01709162|FG000|Participant Flow|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
11121880|NCT01709162|FG001|Participant Flow|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
11121881|NCT01709162|OG000|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
11121882|NCT01709162|OG001|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
11121883|NCT01709162|EG000|Reported Event|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, by intravenous infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
11121884|NCT01709162|EG001|Reported Event|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
11121885|NCT01709227|BG000|Baseline|Furosemide|Patients randomized to receive furosemide
11121886|NCT01709227|BG001|Baseline|Peritoneal Dialysis|Patients randomized to receive peritoneal dialysis
11121887|NCT01709227|BG002|Baseline|Total|Total of all reporting groups
11121888|NCT01709227|FG000|Participant Flow|Furosemide|"Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service.~Furosemide: Patients randomized to the furosemide arm are given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix"
11121889|NCT01709227|FG001|Participant Flow|Peritoneal Dialysis|"Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management will be directed by CICU attending and Nephrology service~Peritoneal Dialysis: Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service.~One potential outcome during use of a peritoneal dialysis catheter is the development of a Pleural Peritoneal communication. In this event, dialysis fluid is instilled in the peritoneum and then leaks into the pleural space through a defect in the diaphragm. This fluid is then drained out of a surgical chest tube. This impairs the ability to perform peritoneal dialysis and thus is a reason to not complete the randomized arm."
11121890|NCT01709227|OG000|Outcome|Furosemide|Patients randomized to furosemide
11121891|NCT01709227|OG001|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
11121892|NCT01709227|OG001|Outcome|Peritoneal Dialysis|Patients randomized to PD
11121893|NCT01709227|EG000|Reported Event|Furosemide|Patients randomized to furosemide
11121894|NCT01709227|EG001|Reported Event|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
11121895|NCT01709305|BG000|Baseline|Overall Study|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20).
11121896|NCT01709305|FG000|Participant Flow|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.
11348445|NCT04171102|EG002|Reported Event|Long Term Post-implantation|Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation
11121897|NCT01709305|FG001|Participant Flow|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 552 participants randomized to this arm in Phase 2.
11121898|NCT01709305|FG002|Participant Flow|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants randomized to this arm in Phase 2.
11121899|NCT01709305|FG003|Participant Flow|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 556 participants randomized to this arm in Phase 2.
11121900|NCT01709305|FG004|Participant Flow|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combinatino therapy for 24 weeks (Week 20 through Week 44). There were 554 participants randomized to this arm in Phase 2.
11121901|NCT01709305|OG000|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
11121902|NCT01709305|OG001|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
11121903|NCT01709305|OG002|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
11121904|NCT01709305|OG003|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
11121905|NCT01709305|OG000|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 501 participants that contributed to the week 44 analysis.
11121906|NCT01709305|OG001|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 502 participants that contributed to the week 44 analysis.
11121907|NCT01709305|OG002|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 551 participants that contributed to the week 44 analysis.
11121908|NCT01709305|OG003|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants that contributed to the week 44 analysis.
11121909|NCT01709305|EG000|Reported Event|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).
11121910|NCT01709305|EG001|Reported Event|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
11121911|NCT01709305|EG002|Reported Event|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
11121912|NCT01709305|EG003|Reported Event|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
11121913|NCT01709305|EG004|Reported Event|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
11121914|NCT01709383|BG000|Baseline|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
11121915|NCT01709383|BG001|Baseline|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
11121916|NCT01709383|BG002|Baseline|Total|Total of all reporting groups
11121917|NCT01709383|FG000|Participant Flow|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
11121918|NCT01709383|FG001|Participant Flow|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
11121919|NCT01709383|OG000|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
11121920|NCT01709383|OG001|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
11348446|NCT04174638|BG000|Baseline|Intervention Group|The intervention group was given 15 minute motivational interviewing for four month period, one session education at the first motivational interviewing and educational booklet based on Watson Human Care Theory.
11348447|NCT04174638|BG001|Baseline|Control Group|The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
11348448|NCT04174638|BG002|Baseline|Total|Total of all reporting groups
11121921|NCT01709383|OG000|Outcome|Transcranial Direct Current Stimulation|"TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period~Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period."
11121922|NCT01709383|OG001|Outcome|Sham Stimulation|"Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.~Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period."
11121923|NCT01709383|EG000|Reported Event|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
11121924|NCT01709383|EG001|Reported Event|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
11121925|NCT01709409|BG000|Baseline|Curosurf (Group 1)|"Surfactant(Curosurf in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. The treatment dose for Curosurf® is 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There is a maximum of 3 doses in the study.~Curosurf-Group1: Maximum of 3 doses are administered to infants diagnosed with RDS."
11121926|NCT01709409|BG001|Baseline|BLES (Group 2)|"Surfactant(BLES in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. For BLES the recommended dose is 5 ml/kg. given by endotracheal method. There is a maximum of 3 doses in the study.~BLES-group 2: Maximum of 3 doses are administered to infants with RDS"
11121927|NCT01709409|BG002|Baseline|Total|Total of all reporting groups
11121928|NCT01709409|FG000|Participant Flow|Curosurf (Group 1)|Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.
11121929|NCT01709409|FG001|Participant Flow|BLES (Group 2)|Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
11121930|NCT01709409|OG000|Outcome|Curosurf (Group 1)|Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.
11121931|NCT01709409|OG001|Outcome|BLES (Group 2)|Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
11121932|NCT01709409|EG000|Reported Event|Curosurf (Group 1)|Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.
11121933|NCT01709409|EG001|Reported Event|BLES (Group 2)|Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
11121934|NCT01709422|BG000|Baseline|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
11121935|NCT01709422|BG001|Baseline|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
11121936|NCT01709422|BG002|Baseline|Total|Total of all reporting groups
11121937|NCT01709422|FG000|Participant Flow|Propofol|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
11121938|NCT01709422|FG001|Participant Flow|Conventional|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
11121939|NCT01709422|OG000|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.
11121940|NCT01709422|OG001|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit.
11121941|NCT01709422|OG000|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation (moderate to deep sedation ) without maximum limit
11121942|NCT01709422|OG001|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3minutes to maintain the desired level of sedation (moderate to deep sedation ) without maximum limit.
11348449|NCT04174638|FG000|Participant Flow|Intervention Group|The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring.
10878744|NCT00454116|EG000|Reported Event|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
11121943|NCT01709422|EG000|Reported Event|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
11121944|NCT01709422|EG001|Reported Event|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
11121945|NCT01709474|BG000|Baseline|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
11121946|NCT01709474|BG001|Baseline|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
11121947|NCT01709474|BG002|Baseline|Total|Total of all reporting groups
11121948|NCT01709474|FG000|Participant Flow|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
11121949|NCT01709474|FG001|Participant Flow|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
11121950|NCT01709474|OG000|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
11121951|NCT01709474|OG001|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
11121952|NCT01709474|EG000|Reported Event|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
11121953|NCT01709474|EG001|Reported Event|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
11121954|NCT01709500|BG000|Baseline|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
11121955|NCT01709500|BG001|Baseline|Placebo|Placebo matched to alirocumab SC injection for 78--week treatment duration.
10845263|NCT00266032|BG001|Baseline|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
10845264|NCT00266032|BG002|Baseline|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
11121956|NCT01709500|BG002|Baseline|Total|Total of all reporting groups
11121957|NCT01709500|FG000|Participant Flow|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
11121958|NCT01709500|FG001|Participant Flow|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
11121959|NCT01709500|OG000|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
11121960|NCT01709500|OG001|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
11121961|NCT01709500|EG000|Reported Event|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
11121962|NCT01709500|EG001|Reported Event|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
11121963|NCT01709513|BG000|Baseline|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable lipid-modifying therapy (LMT).
11121964|NCT01709513|BG001|Baseline|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
11121965|NCT01709513|BG002|Baseline|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
11121966|NCT01709513|BG003|Baseline|Total|Total of all reporting groups
11121967|NCT01709513|FG000|Participant Flow|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable LMT.
11121968|NCT01709513|FG001|Participant Flow|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
11121969|NCT01709513|FG002|Participant Flow|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
11121970|NCT01709513|OG000|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
11121971|NCT01709513|OG001|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
11348450|NCT04174638|FG001|Participant Flow|Control Group|The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
11121972|NCT01709513|OG001|Outcome|Alirocumab 75/ up to 150|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
11121973|NCT01709513|OG000|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
11121974|NCT01709513|OG001|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
11121975|NCT01709513|OG002|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
11121976|NCT01709513|EG000|Reported Event|Atorvastatin|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 22 weeks added to stable LMT.
11121977|NCT01709513|EG001|Reported Event|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo for alirocumab SC injection Q2W for 22 weeks added to stable LMT.
11121978|NCT01709513|EG002|Reported Event|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 22 weeks and placebo for atorvastatin/ezetimibe over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL--C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
11121979|NCT01709578|BG000|Baseline|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121980|NCT01709578|BG001|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121981|NCT01709578|BG002|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121982|NCT01709578|BG003|Baseline|Total|Total of all reporting groups
11121983|NCT01709578|FG000|Participant Flow|Placebo q2w|Placebo matched to sarilumab subcutaneous (SC) injection once every 2 weeks (q2w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks.
11121984|NCT01709578|FG001|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121985|NCT01709578|FG002|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121986|NCT01709578|OG000|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121987|NCT01709578|OG001|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121988|NCT01709578|OG002|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121989|NCT01709578|EG000|Reported Event|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121990|NCT01709578|EG001|Reported Event|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121991|NCT01709578|EG002|Reported Event|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11121992|NCT01709695|BG000|Baseline|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
11121993|NCT01709695|BG001|Baseline|Placebo Group|Flexible dose titration of placebo
11121994|NCT01709695|BG002|Baseline|Total|Total of all reporting groups
11121995|NCT01709695|FG000|Participant Flow|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
11121996|NCT01709695|FG001|Participant Flow|Placebo Group|Flexible dose titration of placebo
11121997|NCT01709695|OG000|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
11121998|NCT01709695|OG001|Outcome|Placebo Group|Flexible dose titration of placebo
11121999|NCT01709695|EG000|Reported Event|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
11122000|NCT01709695|EG001|Reported Event|Placebo Group|Flexible dose titration of placebo
11122001|NCT01709708|BG000|Baseline|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
11122002|NCT01709708|BG001|Baseline|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
11122003|NCT01709708|BG002|Baseline|Total|Total of all reporting groups
11122004|NCT01709708|FG000|Participant Flow|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
11122005|NCT01709708|FG001|Participant Flow|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
11122006|NCT01709708|OG000|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
11122007|NCT01709708|OG001|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
11122008|NCT01709708|OG001|Outcome|Saline|"Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.~Saline: Saline"
11122009|NCT01709708|EG000|Reported Event|Marcaine|"Marcaine (Group A) will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
11122010|NCT01709708|EG001|Reported Event|Saline|Saline (Group B) will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
11122011|NCT01709721|BG000|Baseline|Hydromorphone Hydrochloride (Randomized/Double-Blind)|"Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.~Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone"
11122012|NCT01709721|BG001|Baseline|Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)|Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump
11122013|NCT01709721|BG002|Baseline|Not Randomized (Open Label Only)|"Enrolled but Not Randomized, dropped out during Open Label phase. Open Label treatment only of their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.~Hydromorphone Hydrochloride: Opioid for chronic pain~Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride"
11122014|NCT01709721|BG003|Baseline|Total|Total of all reporting groups
11122015|NCT01709721|FG000|Participant Flow|Hydromorphone Hydrochloride (Randomized/Double-Blind)|"Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.~Hydromorphone Hydrochloride: Opioid for chronic pain~Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride"
11122016|NCT01709721|FG001|Participant Flow|Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)|"Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump~Hydromorphone Hydrochloride: Opioid for chronic pain~Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride"
11122017|NCT01709721|FG002|Participant Flow|Not Randomized (Open Label Only)|"Enrolled but Not Randomized, dropped out during Open Label phase. Open Label treatment only of their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.~Hydromorphone Hydrochloride: Opioid for chronic pain~Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride"
11122018|NCT01709721|OG000|Outcome|Hydromorphone Hydrochloride (Randomized/Double-Blind)|"Subjects on hydromorphone hydrochloride for the duration of therapy.~Hydromorphone Hydrochloride: Opioid for chronic pain~Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone"
11122019|NCT01709721|OG001|Outcome|Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)|"Hydromorphone Hydrochloride/Control Titrated Downward~Hydromorphone Hydrochloride: Opioid for chronic pain~Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone"
11122020|NCT01709721|EG000|Reported Event|Hydromorphone Hydrochloride (Randomized/Double-Blind)|"Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.~Hydromorphone Hydrochloride: Opioid for chronic pain~Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride"
11122021|NCT01709721|EG001|Reported Event|Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)|"Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump~Hydromorphone Hydrochloride: Opioid for chronic pain~Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride"
11122022|NCT01709721|EG002|Reported Event|Not Randomized (Open Label Only)|Enrolled but not randomized [Entered Open Label Phase includes visits from Day 1 until date of randomization (Day 84)]
11122023|NCT01709721|EG003|Reported Event|All Subjects|Total serious adverse events from Day 1 through end of study
11122024|NCT01709747|BG000|Baseline|Hydromorphone Hydrochloride|"Hydromorphone hydrochloride 0.1 mg/day to 10 mg/day based in dose titration, by intrathecal administration, 12 months safety evaluation~Hydromorphone Hydrochloride: Opioid for chronic pain~Programmable Implantable pump: Device: Programmable Implantable pump~Programmable Implantable pump delivering intrathecal hydromorphone"
11122025|NCT01709747|FG000|Participant Flow|Hydromorphone Hydrochloride|"Hydromorphone hydrochloride concentrations of 2mg/mL and 10 mg/mL for 0.1 mg/day to 10 mg/day based in dose titration, by intrathecal administration, 12 months safety evaluation~Hydromorphone Hydrochloride: Opioid for chronic pain~Programmable Implantable pump: Device: Programmable Implantable pump~Programmable Implantable pump delivering intrathecal hydromorphone"
11122026|NCT01709747|OG000|Outcome|Hydromorphone Hydrochloride|"Hydromorphone hydrochloride concentrations of 2 mg/mL and 10 mg/mL for 0.1 mg/day to 10 mg/day based in dose titration, by intrathecal administration, 12 months safety evaluation~Hydromorphone Hydrochloride: Opioid for chronic pain~Programmable Implantable pump: Device: Programmable Implantable pump~Programmable Implantable pump delivering intrathecal hydromorphone"
11122027|NCT01709747|OG000|Outcome|Hydromorphone Hydrochloride|"Hydromorphone hydrochloride concentrations of 2mg/mL and 10 mg/mL for 0.1 mg/day to 10 mg/day based in dose titration, by intrathecal administration, 12 months safety evaluation~Hydromorphone Hydrochloride: Opioid for chronic pain~Programmable Implantable pump: Device: Programmable Implantable pump~Programmable Implantable pump delivering intrathecal hydromorphone"
10845265|NCT00266032|BG003|Baseline|Total|Total of all reporting groups
10878745|NCT00454116|EG001|Reported Event|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
10878746|NCT00454116|EG002|Reported Event|Placebo Plus FOLFIRI|placebo plus FOLFIRI
11122028|NCT01709747|EG000|Reported Event|Hydromorphone Hydrochloride|"Hydromorphone hydrochloride concentrations of 2mg/mL and 10 mg/mL for 0.1 mg/day to 10 mg/day based in dose titration, by intrathecal administration, 12 months safety evaluation~Hydromorphone Hydrochloride: Opioid for chronic pain~Programmable Implantable pump: Device: Programmable Implantable pump~Programmable Implantable pump delivering intrathecal hydromorphone"
11122029|NCT01709786|BG000|Baseline|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
11122030|NCT01709786|FG000|Participant Flow|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
11122031|NCT01709786|OG000|Outcome|Radical-7 Hemoglobin|Radical-7 hemoglobin measurement
11122032|NCT01709786|OG001|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
11122033|NCT01709786|OG000|Outcome|iSTAT Hemoglobin|iSTAT hemoglobin measurement
11122034|NCT01709786|EG000|Reported Event|Radical-7 vs. CBC|All patients: Difference between Radical-Y hemoglobin measurement and CBC hemoglobin measurement
11122035|NCT01709799|BG000|Baseline|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
11122036|NCT01709799|BG001|Baseline|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
11122037|NCT01709799|BG002|Baseline|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
11122038|NCT01709799|BG003|Baseline|Total|Total of all reporting groups
11122039|NCT01709799|FG000|Participant Flow|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
11122040|NCT01709799|FG001|Participant Flow|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
11122041|NCT01709799|FG002|Participant Flow|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
11348451|NCT04174638|OG000|Outcome|Intervention Group|The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring.
10845266|NCT00266032|FG000|Participant Flow|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
11122042|NCT01709799|OG000|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
11122043|NCT01709799|OG001|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
11122044|NCT01709799|OG002|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
11122045|NCT01709799|EG000|Reported Event|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
11122046|NCT01709799|EG001|Reported Event|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
11122047|NCT01709799|EG002|Reported Event|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
11122048|NCT01709838|BG000|Baseline|Deferasirox|All patients were treated with 10mg/kg/day deferasirox with dose adjustments after 4 weeks of treatment according to baseline Liver Iron Concentration (LIC).
11122049|NCT01709838|FG000|Participant Flow|Deferasirox|All patients were treated with 10mg/kg/day deferasirox with dose adjustments after 4 weeks of treatment according to baseline Liver Iron Concentration (LIC).
11122050|NCT01709838|OG000|Outcome|Deferasirox|All patients were treated with 10mg/kg/day deferasirox with dose adjustments after 4 weeks of treatment according to baseline Liver Iron Concentration (LIC).
11122051|NCT01709838|EG000|Reported Event|Chinese|This group was comprised of Chinese participants only
11122052|NCT01709838|EG001|Reported Event|Non-Chinese|This group was comprised of non- Chinese participants only
11122053|NCT01709838|EG002|Reported Event|All Patients|This group was comprised of all patients: Chinese and non-Chinese participants
10878747|NCT00454142|BG000|Baseline|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
11122054|NCT01709864|BG000|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11122055|NCT01709864|BG001|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
11122056|NCT01709864|BG002|Baseline|Total|Total of all reporting groups
10878748|NCT00454142|FG000|Participant Flow|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
11122057|NCT01709864|FG000|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11122058|NCT01709864|FG001|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
11122059|NCT01709864|OG000|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11122060|NCT01709864|OG001|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
11122061|NCT01709864|EG000|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11122062|NCT01709864|EG001|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
11122063|NCT01709903|BG000|Baseline|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
11122064|NCT01709903|BG001|Baseline|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
11122065|NCT01709903|BG002|Baseline|Total|Total of all reporting groups
11122066|NCT01709903|FG000|Participant Flow|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
11122067|NCT01709903|FG001|Participant Flow|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
11122068|NCT01709903|OG000|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
11122069|NCT01709903|OG001|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
11122070|NCT01709903|EG000|Reported Event|QVA149 110mcg/50mcg|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
11122071|NCT01709903|EG001|Reported Event|Salmeterol/Fluticasone 50mcg/500mcg|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
11122072|NCT01710020|BG000|Baseline|Entire Study Population|Includes all participants enrolled in the study.
11122073|NCT01710020|FG000|Participant Flow|CP-690,550 (10 mg OPC)|Single oral dose of CP-690,550 10 milligram (mg) oral powder for constitution (OPC) 1 to 2 hours (hrs) post-hemodialysis in Period 1 followed by single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2. A washout period of at least 14 days was maintained between each intervention period.
11122074|NCT01710020|OG000|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
11348452|NCT04174638|OG001|Outcome|Control Group|The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
11122075|NCT01710020|OG000|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
11122076|NCT01710020|EG000|Reported Event|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
11122077|NCT01710020|EG001|Reported Event|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
11122078|NCT01710033|BG000|Baseline|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
11122079|NCT01710033|BG001|Baseline|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
11122080|NCT01710033|BG002|Baseline|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
11122081|NCT01710033|BG003|Baseline|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
11122082|NCT01710033|BG004|Baseline|Total|Total of all reporting groups
11122083|NCT01710033|FG000|Participant Flow|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (mycophenolate mofetil [MMF] with or without calcineurin inhibitor [cyclosporine {CsA} or tacrolimus {TAC}]) as per local clinical practice in Stage 1.
11122084|NCT01710033|FG001|Participant Flow|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
11122085|NCT01710033|FG002|Participant Flow|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
11122086|NCT01710033|FG003|Participant Flow|CP-690,550 30 mg, Stage 1|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1.
11122087|NCT01710033|FG004|Participant Flow|CP-690,550 30 mg, Stage 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 2.
11122088|NCT01710033|OG000|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
11122089|NCT01710033|OG001|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
11122090|NCT01710033|OG002|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
11122091|NCT01710033|OG000|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
11122092|NCT01710033|OG001|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
11122093|NCT01710033|OG002|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
11122094|NCT01710033|OG003|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
11122095|NCT01710033|EG000|Reported Event|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
11122096|NCT01710033|EG001|Reported Event|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
11122097|NCT01710033|EG002|Reported Event|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
11122098|NCT01710033|EG003|Reported Event|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
11122099|NCT01710046|BG000|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
11122100|NCT01710046|BG001|Baseline|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
11122101|NCT01710046|BG002|Baseline|Total|Total of all reporting groups
11122102|NCT01710046|FG000|Participant Flow|Tofacitinib 10 Milligrams (mg) Twice Daily (BID)|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
11122103|NCT01710046|FG001|Participant Flow|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
11122104|NCT01710046|OG000|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
11122105|NCT01710046|OG001|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
11122106|NCT01710046|EG000|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
11122107|NCT01710046|EG001|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
11122108|NCT01710137|BG000|Baseline|Varenicline|"12 weeks of active varenicline + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Varenicline~Smoking Cessation Counseling"
11122109|NCT01710137|BG001|Baseline|Placebo|"12 weeks of placebo + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Placebo~Smoking Cessation Counseling"
11122110|NCT01710137|BG002|Baseline|Total|Total of all reporting groups
11122111|NCT01710137|FG000|Participant Flow|Varenicline|"12 weeks of active varenicline + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Varenicline~Smoking Cessation Counseling"
11122112|NCT01710137|FG001|Participant Flow|Placebo|"12 weeks of placebo + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Placebo~Smoking Cessation Counseling"
11122113|NCT01710137|OG000|Outcome|Varenicline|"12 weeks of active varenicline + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Varenicline~Smoking Cessation Counseling"
11122114|NCT01710137|OG001|Outcome|Placebo|"12 weeks of placebo + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Placebo~Smoking Cessation Counseling"
11122115|NCT01710137|EG000|Reported Event|Varenicline|"12 weeks of active varenicline + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Varenicline~Smoking Cessation Counseling"
11122116|NCT01710137|EG001|Reported Event|Placebo|"12 weeks of placebo + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Placebo~Smoking Cessation Counseling"
11122117|NCT01710254|BG000|Baseline|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
11122118|NCT01710254|FG000|Participant Flow|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
11122119|NCT01710254|OG000|Outcome|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
11122120|NCT01710254|EG000|Reported Event|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
11122121|NCT01710306|BG000|Baseline|Outreach|To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. That is, VA existing outreach by existing OEF/OIF/OND transition patient advocates.
11122122|NCT01710306|BG001|Baseline|Study Concierge Nurse Case Manager (NCM)|To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
11122123|NCT01710306|BG002|Baseline|Total|Total of all reporting groups
11122124|NCT01710306|FG000|Participant Flow|Outreach|To evaluate and test differences in VA initiation and use for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. That is, VA usual outreach by existing OEF/OIF/OND transition patient advocates.
11122125|NCT01710306|FG001|Participant Flow|Study Concierge Nurse Case Manager (NCM)|"To evaluate and test differences in VA initiation (did they seek VA care - new or return visit) and for participants who screen positive for PTSD they will be randomly assigned to either: 1)Study nurse case manager (NCM) or outreach as usual..~NCM: Nurse care manager interventions will consist of telephone delivered shared decision protocols with participants compared to OEF/OIF/OND outreach as usual."
11122126|NCT01710306|OG000|Outcome|Outreach|To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
11122127|NCT01710306|OG001|Outcome|Nurse Care Manger Intervention Arm|To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
11122128|NCT01710306|OG001|Outcome|Nurse Care Manager (NCM)|"To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.~Nurse Care Manager (NCM): Nurse care manager interventions with telephone implemented shared decision making protocol compared to outreach as usual OEF/OIF/OND outreach."
11122129|NCT01710306|EG000|Reported Event|Outreach|To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
11122130|NCT01710306|EG001|Reported Event|Study Concierge Nurse Case Manager (NCM)|To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
11122131|NCT01710332|BG000|Baseline|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
11122132|NCT01710332|BG001|Baseline|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
11122133|NCT01710332|BG002|Baseline|Total|Total of all reporting groups
11122134|NCT01710332|FG000|Participant Flow|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
11122135|NCT01710332|FG001|Participant Flow|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
11122136|NCT01710332|OG000|Outcome|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
11122137|NCT01710332|OG001|Outcome|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
11122138|NCT01710332|EG000|Reported Event|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
11122139|NCT01710332|EG001|Reported Event|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
11122140|NCT01710345|BG000|Baseline|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
11122141|NCT01710345|BG001|Baseline|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
11122142|NCT01710345|BG002|Baseline|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
11122143|NCT01710345|BG003|Baseline|Total|Total of all reporting groups
11122144|NCT01710345|FG000|Participant Flow|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
11122145|NCT01710345|FG001|Participant Flow|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
11122146|NCT01710345|FG002|Participant Flow|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
11122147|NCT01710345|OG000|Outcome|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
11122148|NCT01710345|OG001|Outcome|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
11122149|NCT01710345|OG002|Outcome|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
11122150|NCT01710345|EG000|Reported Event|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
11122151|NCT01710345|EG001|Reported Event|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
11122152|NCT01710345|EG002|Reported Event|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
11122153|NCT01710358|BG000|Baseline|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.~At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background methotrexate (MTX) therapy throughout study."
11122154|NCT01710358|BG001|Baseline|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
11122155|NCT01710358|BG002|Baseline|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX) therapy throughout study."
11122156|NCT01710358|BG003|Baseline|Total|Total of all reporting groups
11122157|NCT01710358|FG000|Participant Flow|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.~At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background methotrexate (MTX) therapy throughout study."
11122158|NCT01710358|FG001|Participant Flow|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
11122159|NCT01710358|FG002|Participant Flow|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
11122160|NCT01710358|OG000|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
11122161|NCT01710358|OG001|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
11122162|NCT01710358|OG002|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
11122163|NCT01710358|OG002|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who are were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants will continued to take background MTX therapy throughout study."
11122164|NCT01710358|OG001|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib will continue to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants will continue to take background MTX therapy throughout study."
11122165|NCT01710358|OG002|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 52.~Participants will continue to take background MTX therapy throughout study."
11122166|NCT01710358|OG001|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study.~."
11122167|NCT01710358|OG001|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study.~Baricitinib: Administered orally"
11122168|NCT01710358|OG000|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52
11122169|NCT01710358|EG000|Reported Event|Placebo Treatment A|"Placebo Treatment A (week 0-24).~Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.~At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
11122170|NCT01710358|EG001|Reported Event|Baricitinib Treatment A|"Baricitinib Treatment A (week 0-24).~Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52."
11122171|NCT01710358|EG002|Reported Event|Adalimumab Treatment A|"Adalimumab Treatment A (week 0-24).~Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
11122172|NCT01710358|EG003|Reported Event|Placebo Treatment B|"Placebo Treatment B (week 24-52).~Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.~At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
11122173|NCT01710358|EG004|Reported Event|BaricitinibTreatment B|"Baricitinib Treatment B (week 24-52).~Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52."
11122174|NCT01710358|EG005|Reported Event|Adalimumab Treatment B|"Adalimumab Treatment B (week 24-52).~Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
11122175|NCT01710358|EG006|Reported Event|Rescue|Baricitinib 4 mg administered PO QD through Week 52 (Week 16-52).
11122176|NCT01710358|EG007|Reported Event|Placebo Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11122177|NCT01710358|EG008|Reported Event|Baricitinib Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Participants who were rescued or switched to Baricitinib 4 mg.
11122178|NCT01710358|EG009|Reported Event|Adalimumab Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11122179|NCT01710501|BG000|Baseline|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122180|NCT01710501|BG001|Baseline|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122181|NCT01710501|BG002|Baseline|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122182|NCT01710501|BG003|Baseline|Total|Total of all reporting groups
11122183|NCT01710501|FG000|Participant Flow|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122184|NCT01710501|FG001|Participant Flow|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122185|NCT01710501|FG002|Participant Flow|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122186|NCT01710501|OG000|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122187|NCT01710501|OG001|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122188|NCT01710501|OG002|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122189|NCT01710501|EG000|Reported Event|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122190|NCT01710501|EG001|Reported Event|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122191|NCT01710501|EG002|Reported Event|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
11122192|NCT01710514|BG000|Baseline|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
11122193|NCT01710514|BG001|Baseline|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
11122194|NCT01710514|BG002|Baseline|Total|Total of all reporting groups
11122195|NCT01710514|FG000|Participant Flow|FE 999913 100 mg BID|"FE 999913 100 mg vaginal tablet BID~FE 999913 vaginal tablet"
11122196|NCT01710514|FG001|Participant Flow|FE 999913 100 mg TID|"FE 999913 100 mg vaginal tablet TID~FE 999913 vaginal tablet"
11122197|NCT01710514|OG000|Outcome|FE999913 000072 (BID/TID)|Data pooled from both BID and TID groups
11122198|NCT01710514|OG000|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
11122199|NCT01710514|OG001|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
11122200|NCT01710514|OG002|Outcome|FE 999913 Total|Data pooled from BID and TID groups
11122201|NCT01710514|EG000|Reported Event|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
11122202|NCT01710514|EG001|Reported Event|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
11122203|NCT01710514|EG002|Reported Event|FE 999913 Total|Data pooled from BID and TID groups
11122204|NCT01710527|BG000|Baseline|Treatment T-Metformin 500 mg + Treatment R-Glucophage 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet) or treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
11122205|NCT01710527|FG000|Participant Flow|Treatment T-Metformin 500mg, Then Treatment R-Glucophage 500mg|Participants received one tablet of treatment T (Metformin 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 minutes (min) for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment R (Glucophage 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 ante meridiem (am) and 8:30 am on Day 1 (dosing day) of each study period.
11122206|NCT01710527|FG001|Participant Flow|Treatment R-Glucophage 500mg, Then Treatment T-Metformin 500mg|Participants received one tablet of treatment R (Glucophage 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment T (Metformin 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period.
11122207|NCT01710527|OG000|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
11122208|NCT01710527|OG001|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
11122209|NCT01710527|EG000|Reported Event|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
11122210|NCT01710527|EG001|Reported Event|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
11122211|NCT01710657|BG000|Baseline|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
11122212|NCT01710657|BG001|Baseline|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
11122213|NCT01710657|BG002|Baseline|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
11122214|NCT01710657|BG003|Baseline|Total|Total of all reporting groups
11122215|NCT01710657|FG000|Participant Flow|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
11122216|NCT01710657|FG001|Participant Flow|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
11122217|NCT01710657|FG002|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
11122218|NCT01710657|OG000|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
11122219|NCT01710657|OG001|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
11122220|NCT01710657|OG002|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
11122221|NCT01710657|EG000|Reported Event|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
11122222|NCT01710657|EG001|Reported Event|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
11122223|NCT01710657|EG002|Reported Event|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
11122224|NCT01710709|BG000|Baseline|Phase C: Open-label IM Depot Maintenance Phase|All de novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. Aripiprazole IM depot injections were administered every 4 weeks for a maximum of 52 weeks. Flexible dosing with aripiprazole IM depot 300 mg and 400 mg was permitted as often as necessary during the open-label treatment period. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. For participants who completed Trial 31-08-250 (some of whom had received double-blind placebo), the use of supplemental oral aripiprazole for the first ≤ 2 weeks was at the investigator's discretion based on the clinical status of the participant.
11122225|NCT01710709|FG000|Participant Flow|Phase C: Open-Label IM Depot Maintenance Phase|All de novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. Aripiprazole IM depot injections were administered every 4 weeks for a maximum of 52 weeks. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. Note: Data for Open-label aripiprazole IM depot maintenance phase (Phase C) is presented in the table below which included both rollover participants (those who had completed Trial 31-08-250 and entered into the Open-label aripiprazole IM depot maintenance phase directly) and de novo participants (ie, those who did not participate in Trial 31-08-250 and went through Screening phase, Conversion Phase, and Oral aripiprazole stabilization phase).
11336513|NCT03567382|BG000|Baseline|High-risk Mothers|"Mothers with high-risk HBV (defined as viral load >10^6 and/or HBeAg positivity) will be treated with tenofovir disoproxil fumarate (TDF) to further reduce the risk of vertical transmission of HBV. All HBV-exposed infants (regardless of mother's status of high- or low-risk HBV) will receive monovalent HBV vaccine within 24 hours of life.~Tenofovir Disoproxil Fumarate: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.~Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life."
11122226|NCT01710709|OG000|Outcome|Phase C: Open-label IM Depot Maintenance Phase|All de novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. Aripiprazole IM depot injections were administered every 4 weeks for a maximum of 52 weeks. Flexible dosing with aripiprazole IM depot 300 mg and 400 mg was permitted as often as necessary during the open-label treatment period. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. For participants who completed Trial 31-08-250 (some of whom had received double-blind placebo), the use of supplemental oral aripiprazole for the first ≤ 2 weeks was at the investigator's discretion based on the clinical status of the participant.
11122227|NCT01710709|OG000|Outcome|Phase C: Open-label IM Depot Maintenance Phase|All de novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. Aripiprazole IM depot injections were administered every 4 weeks for a maximum of 52 weeks. Flexible dosing with aripiprazole IM depot 300 mg and 400 mg was permitted as often as necessary during the open-label treatment period. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. For participants who completed Trial 31-08-250 (some of whom had received double-blind placebo), the use of supplemental oral aripiprazole for the first ≤ 2 weeks was at the investigator's discretion based on the clinical status of the participant. Results using last observation carried forward (LOCF) were presented.
11122228|NCT01710709|EG000|Reported Event|Phase C: Open-Label IM Depot Maintenance Phase|All de novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. Aripiprazole IM depot injections were administered every 4 weeks for a maximum of 52 weeks. Flexible dosing with aripiprazole IM depot 300 mg and 400 mg was permitted as often as necessary during the open-label treatment period. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. For participants who completed Trial 31-08-250 (some of whom had received double-blind placebo), the use of supplemental oral aripiprazole for the first ≤ 2 weeks was at the investigator's discretion based on the clinical status of the participant.
11122229|NCT01710787|BG000|Baseline|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
11122230|NCT01710787|BG001|Baseline|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
11122231|NCT01710787|BG002|Baseline|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
11122232|NCT01710787|BG003|Baseline|Total|Total of all reporting groups
11122233|NCT01710787|FG000|Participant Flow|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
11122234|NCT01710787|FG001|Participant Flow|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
11122235|NCT01710787|FG002|Participant Flow|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
11122236|NCT01710787|OG000|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
11122237|NCT01710787|OG001|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
11122238|NCT01710787|OG002|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
11122239|NCT01710787|EG000|Reported Event|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
11122240|NCT01710787|EG001|Reported Event|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
11122241|NCT01710787|EG002|Reported Event|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
11122242|NCT01710800|BG000|Baseline|All Study Participants|Patients will be randomized to receive either PPI or placebo (sequence 1) and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes. Sequence 2 (placebo or PPI) will be administered followed by repeat 24 hour pH with impedance.
11122243|NCT01710800|FG000|Participant Flow|First Intervention (7 Days), Second Intervention (7 Days)|Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.
11122244|NCT01710800|OG000|Outcome|Placebo Arm|Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes
11122245|NCT01710800|OG001|Outcome|Esomeprazole|Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
11122246|NCT01710800|EG000|Reported Event|Placebo Arm|
11122247|NCT01710800|EG001|Reported Event|PPI Arm|
11122248|NCT01710839|BG000|Baseline|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
11122249|NCT01710839|BG001|Baseline|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
11122250|NCT01710839|BG002|Baseline|Total|Total of all reporting groups
11122251|NCT01710839|FG000|Participant Flow|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
11122252|NCT01710839|FG001|Participant Flow|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
11122253|NCT01710839|OG000|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
11122254|NCT01710839|OG001|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
11122255|NCT01710839|EG000|Reported Event|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
11122256|NCT01710839|EG001|Reported Event|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
11122257|NCT01710891|BG000|Baseline|Direct Laryngoscopy|"Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.~Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood."
11122258|NCT01710891|BG001|Baseline|CMAC|"Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance~CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope"
11122259|NCT01710891|BG002|Baseline|Total|Total of all reporting groups
11122260|NCT01710891|FG000|Participant Flow|Direct Laryngoscopy|"Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.~Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood."
11122261|NCT01710891|FG001|Participant Flow|CMAC|"Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance~CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope"
11122262|NCT01710891|OG000|Outcome|Direct Laryngoscopy|"Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.~Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood."
11122263|NCT01710891|OG001|Outcome|CMAC|"Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance~CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope"
11122264|NCT01710891|EG000|Reported Event|Direct Laryngoscopy|"Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.~Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood."
11122265|NCT01710891|EG001|Reported Event|CMAC|"Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance~CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope"
11122266|NCT01711177|BG000|Baseline|Normal Control|"Normal patient placebo~placebo: Placebo"
11122267|NCT01711177|BG001|Baseline|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
11122268|NCT01711177|BG002|Baseline|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
11122269|NCT01711177|BG003|Baseline|Total|Total of all reporting groups
11122270|NCT01711177|FG000|Participant Flow|Normal Control|"Normal patient placebo~placebo: Placebo"
11122271|NCT01711177|FG001|Participant Flow|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
11122272|NCT01711177|FG002|Participant Flow|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
11122273|NCT01711177|OG000|Outcome|Normal Control|"Normal patient placebo~placebo: Placebo"
11122274|NCT01711177|OG001|Outcome|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
11122275|NCT01711177|OG002|Outcome|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
11122276|NCT01711177|EG000|Reported Event|Normal Control|"Normal patient placebo~placebo: Placebo"
11122277|NCT01711177|EG001|Reported Event|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
11122278|NCT01711177|EG002|Reported Event|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
11122279|NCT01711216|BG000|Baseline|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
11122280|NCT01711216|FG000|Participant Flow|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
11122281|NCT01711216|OG000|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
11122282|NCT01711216|EG000|Reported Event|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
11122283|NCT01711294|BG000|Baseline|19G Flex Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)~19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle."
11122284|NCT01711294|BG001|Baseline|22G Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)~22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle."
11122285|NCT01711294|BG002|Baseline|19G Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)~19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle."
11122286|NCT01711294|BG003|Baseline|Total|Total of all reporting groups
11122287|NCT01711294|FG000|Participant Flow|19G Flex Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)~19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle."
11122288|NCT01711294|FG001|Participant Flow|22G Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)~22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle."
11122289|NCT01711294|FG002|Participant Flow|19G Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)~19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle."
11122290|NCT01711294|OG000|Outcome|19G Flex Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)~19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle."
11122291|NCT01711294|OG001|Outcome|22G Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)~22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle."
11122292|NCT01711294|OG002|Outcome|19G Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)~19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle."
11122293|NCT01711294|EG000|Reported Event|19G Flex Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)~19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle."
11122294|NCT01711294|EG001|Reported Event|22G Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)~22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle."
11122295|NCT01711294|EG002|Reported Event|19G Needle|"Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)~19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle."
11122296|NCT01711359|BG000|Baseline|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122297|NCT01711359|BG001|Baseline|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122298|NCT01711359|BG002|Baseline|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122299|NCT01711359|BG003|Baseline|Total|Total of all reporting groups
11122300|NCT01711359|FG000|Participant Flow|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122301|NCT01711359|FG001|Participant Flow|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122302|NCT01711359|FG002|Participant Flow|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122303|NCT01711359|OG000|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122304|NCT01711359|OG001|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122305|NCT01711359|OG002|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122306|NCT01711359|OG000|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122307|NCT01711359|EG000|Reported Event|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122308|NCT01711359|EG001|Reported Event|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122309|NCT01711359|EG002|Reported Event|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
11122310|NCT01711359|EG003|Reported Event|Rescue Period|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52.
11122311|NCT01711359|EG004|Reported Event|Methotrexate - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11122312|NCT01711359|EG005|Reported Event|Baricitinib - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11122313|NCT01711359|EG006|Reported Event|Baricitinib + MTX - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib + MTX.
11122314|NCT01711372|BG000|Baseline|ADHD Group|"Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities.~Groundskeeper Game: The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes."
11122315|NCT01711372|BG001|Baseline|Control Group|"Controls played a go/no go task on Sifteo Cubes to asses for attentional capabilities.~Groundskeeper Game: The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes."
11122316|NCT01711372|BG002|Baseline|Total|Total of all reporting groups
11122317|NCT01711372|FG000|Participant Flow|ADHD Group|Patients with ADHD played a go/no go task on Sifteo cubes to assess for attentional capabilities. Groundskeeper Game: The Groundskeeper game is a go/no-go task that captures reaction time and movement using the accelerometers and touch capabilities on the Sanvello cubes.
11122318|NCT01711372|FG001|Participant Flow|Control Group|Controls played a go/no go task on Sifteo cubes to assess for attentional capabilities. Groundskeeper Game: The Groundskeeper game is a go/no-go task that captures reaction time and movement using the accelerometers and touch capabilities on the Sanvello cubes.
11122319|NCT01711372|OG000|Outcome|All Participants in the Study With and Without ADHD|Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.
11122320|NCT01711372|EG000|Reported Event|ADHD Group|"Patient with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities.~Groundskeeper Game: The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo Cubes."
11122321|NCT01711372|EG001|Reported Event|Control Group|"Patient with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities.~Groundskeeper Game: The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo Cubes."
11122322|NCT01711424|BG000|Baseline|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
11122323|NCT01711424|FG000|Participant Flow|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
11122324|NCT01711424|OG000|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
11122325|NCT01711424|EG000|Reported Event|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
11122326|NCT01711619|BG000|Baseline|SQS+OMM|Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)
11122327|NCT01711619|BG001|Baseline|OMM Alone|Optimized Medical Management alone (OMM)
11122328|NCT01711619|BG002|Baseline|Total|Total of all reporting groups
11122329|NCT01711619|FG000|Participant Flow|SQS+OMM|Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)
11122330|NCT01711619|FG001|Participant Flow|OMM Alone|Optimized Medical Management alone (OMM)
11122331|NCT01711619|OG000|Outcome|SQS+OMM|Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)
11122332|NCT01711619|OG001|Outcome|OMM Alone|Optimized Medical Management alone (OMM)
11122333|NCT01711619|EG000|Reported Event|SQS+OMM|Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)
11122334|NCT01711619|EG001|Reported Event|OMM Alone|Optimized Medical Management alone (OMM)
11122335|NCT01711645|BG000|Baseline|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
11122336|NCT01711645|FG000|Participant Flow|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
11122337|NCT01711645|OG000|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
11122338|NCT01711645|EG000|Reported Event|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
11348453|NCT04174638|OG000|Outcome|"Intervention Group"|"The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring.~Motivational Interviewing and Education Based on Watson's Theory of Human Caring: The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. The intervention performed before the hemodialysis session in a separate room in the hemodialysis unit."
11348454|NCT04174638|OG001|Outcome|"Control Group"|The control group received routine hemodialysis treatment and nursing care in the hemodialysis unit.
11348455|NCT04174638|OG001|Outcome|Control Group|The control group received routine hemodialysis treatment and nursing care in the hemodialysis unit
11348456|NCT04174638|EG000|Reported Event|Intervention Group|The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring.
11348457|NCT04174638|EG001|Reported Event|Control Group|The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
11348458|NCT04174313|BG000|Baseline|VILI VORTEX|Participants who evolved with VILI vortex clinical criteria
11122339|NCT01711658|BG000|Baseline|IMRT + Cisplatin + Placebo|"IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m^2 administered intravenously on days 8 and 29~Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT"
11122340|NCT01711658|BG001|Baseline|IMRT + Cisplatin + Lapatinib|"IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m^2 administered intravenously on days 8 and 29~Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT"
11348459|NCT04174313|BG001|Baseline|No VILI VORTEX|Participants who evolved without clinical criteria for VILI vortex
11348460|NCT04174313|BG002|Baseline|Total|Total of all reporting groups
11122341|NCT01711658|BG002|Baseline|Total|Total of all reporting groups
11122342|NCT01711658|FG000|Participant Flow|IMRT + Cisplatin + Placebo|"Intensity Modulated Radiation Therapy (IMRT), 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m^2 administered intravenously on days 8 and 29~Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT"
11122343|NCT01711658|FG001|Participant Flow|IMRT + Cisplatin + Lapatinib|"IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m^2 administered intravenously on days 8 and 29~Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT"
11122344|NCT01711658|OG000|Outcome|IMRT + Cisplatin + Placebo|"IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m^2 administered intravenously on days 8 and 29~Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT"
11122345|NCT01711658|OG001|Outcome|IMRT + Cisplatin + Lapatinib|"IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m^2 administered intravenously on days 8 and 29~Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT"
11348461|NCT04174313|FG000|Participant Flow|VILI VORTEX|Clinical categorization of patients with SARS-CoV-2 with VILI vortex
11348462|NCT04174313|FG001|Participant Flow|NO VILI VORTEX|Clinical categorization of patients with SARS-CoV-2 without VILI vortex
11348463|NCT04174313|OG000|Outcome|VILI VORTEX|Patients who evolved with clinical criteria of VILI VORTEX
11348464|NCT04174313|OG001|Outcome|No VILI VORTEX|Patients who evolved without clinical criteria of VILI VORTEX
11348465|NCT04174313|OG000|Outcome|No VILI VORTEX|Participants who evolved without clinical criteria for VILI vortex
11348466|NCT04174313|OG001|Outcome|VILI VORTEX|Participants who evolved with VILI vortex clinical criteria
11348467|NCT04174313|OG000|Outcome|VILI VORTEX|Participants who evolved with VILI vortex clinical criteria
11348468|NCT04174313|OG001|Outcome|No VILI VORTEX|Participants who evolved without clinical criteria for VILI vortex
11122346|NCT01711658|EG000|Reported Event|IMRT + Cisplatin + Placebo|"IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m^2 administered intravenously on days 8 and 29~Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT"
11122347|NCT01711658|EG001|Reported Event|IMRT + Cisplatin + Lapatinib|"IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m^2 administered intravenously on days 8 and 29~Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT"
11122348|NCT01711736|BG000|Baseline|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122349|NCT01711736|BG001|Baseline|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122350|NCT01711736|BG002|Baseline|Total|Total of all reporting groups
11122351|NCT01711736|FG000|Participant Flow|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122352|NCT01711736|FG001|Participant Flow|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122353|NCT01711736|OG000|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122354|NCT01711736|OG001|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122355|NCT01711736|OG000|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122356|NCT01711736|EG000|Reported Event|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122357|NCT01711736|EG001|Reported Event|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
11122358|NCT01711853|BG000|Baseline|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
11122359|NCT01711853|FG000|Participant Flow|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
11122360|NCT01711853|OG000|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
11122361|NCT01711853|EG000|Reported Event|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
11122362|NCT01711866|BG000|Baseline|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
11122363|NCT01711866|FG000|Participant Flow|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
11348469|NCT04174313|EG000|Reported Event|VILI VORTEX|SARS-CoV-2 patients who evolved with VILI VORTEX
10845267|NCT00266032|FG001|Participant Flow|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
11122364|NCT01711866|OG000|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
11122365|NCT01711866|EG000|Reported Event|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
11122366|NCT01711918|BG000|Baseline|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
11122367|NCT01711918|FG000|Participant Flow|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
11122368|NCT01711918|OG000|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
11122369|NCT01711918|EG000|Reported Event|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
11122370|NCT01711983|BG000|Baseline|Test Device|ASD closure with the GORE® CARDIOFORM Septal Occluder
11122371|NCT01711983|FG000|Participant Flow|Test Device|"ASD closure with the GORE® CARDIOFORM Septal Occluder~Percutaneous Atrial Septal Defect Closure"
11122372|NCT01711983|OG000|Outcome|Test Device|ASD closure with the GORE® CARDIOFORM Septal Occluder
11122373|NCT01711983|EG000|Reported Event|Test Device|ASD closure with the GORE® CARDIOFORM Septal Occluder
11122374|NCT01712009|BG000|Baseline|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
11122375|NCT01712009|BG001|Baseline|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
11122376|NCT01712009|BG002|Baseline|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
11122377|NCT01712009|BG003|Baseline|Total|Total of all reporting groups
11122378|NCT01712009|FG000|Participant Flow|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
11122379|NCT01712009|FG001|Participant Flow|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
11122380|NCT01712009|FG002|Participant Flow|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
11122381|NCT01712009|OG000|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
11122382|NCT01712009|OG001|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
11122383|NCT01712009|OG002|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
11122384|NCT01712009|EG000|Reported Event|No Prophylactic Intervention|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
11122385|NCT01712009|EG001|Reported Event|Naproxen 500mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
11122386|NCT01712009|EG002|Reported Event|Loratadine 10mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
11122387|NCT01712061|BG000|Baseline|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
11122388|NCT01712061|BG001|Baseline|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
11122389|NCT01712061|BG002|Baseline|Total|Total of all reporting groups
11122390|NCT01712061|FG000|Participant Flow|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
11122391|NCT01712061|FG001|Participant Flow|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
11122392|NCT01712061|FG002|Participant Flow|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
11122393|NCT01712061|OG000|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
11122394|NCT01712061|OG001|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
11122395|NCT01712061|OG000|Outcome|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
11122396|NCT01712061|OG001|Outcome|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
11122397|NCT01712061|EG000|Reported Event|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
11122398|NCT01712061|EG001|Reported Event|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
11122399|NCT01712061|EG002|Reported Event|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
11122400|NCT01712074|BG000|Baseline|Not Randomized|Participants who have been discontinued during the Placebo Run-In period
11122401|NCT01712074|BG001|Baseline|PF-05212377 30 mg: Double Blind Period|All participants entered the double blind period and received PF-05212377 30 mg
11122402|NCT01712074|BG002|Baseline|Placebo: Double Blind Period|All participants entered the double blind period and received placebo
11122403|NCT01712074|BG003|Baseline|Total|Total of all reporting groups
11122404|NCT01712074|FG000|Participant Flow|Placebo Run-In|Participants that received placebo during the 4-week single blind placebo run-in period
11122405|NCT01712074|FG001|Participant Flow|PF-05212377 30 mg: Double Blind Period|All participants that received PF-05212377 30 mg during the 12-week double blind period
11122406|NCT01712074|FG002|Participant Flow|Placebo: Double Blind Period|All participants that received placebo during the 12-week double blind period
11122407|NCT01712074|OG000|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
11122408|NCT01712074|OG001|Outcome|Placebo|All participants who received placebo contributing to the analysis during the double blind period
11122409|NCT01712074|OG001|Outcome|Placebo|All participants receiving placebo during double blind period
11122410|NCT01712074|OG001|Outcome|Placebo|All participants receiving placebo with non-missing clinical laboratory data during double blind period
11348470|NCT04174313|EG001|Reported Event|NO VILI VORTEX|SARS-CoV-2 patients who evolved without VILI VORTEX
11122411|NCT01712074|OG001|Outcome|Placebo|All participants who received placebo with non-missing ECG data during the double blind period
11122412|NCT01712074|OG001|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
11122413|NCT01712074|OG001|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
11122414|NCT01712074|OG000|Outcome|Placebo Run-in|All participants assigned to the placebo run-in period
11122415|NCT01712074|OG001|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
11122416|NCT01712074|OG002|Outcome|Placebo|All participants received placebo during double blind period
11122417|NCT01712074|EG000|Reported Event|Placebo Run-In|Participants received placebo during the single blind placebo run-in period
11122418|NCT01712074|EG001|Reported Event|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
11122419|NCT01712074|EG002|Reported Event|Placebo|All participants receiving placebo during double blind period
11122420|NCT01712178|BG000|Baseline|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
11122421|NCT01712178|BG001|Baseline|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
11122422|NCT01712178|BG002|Baseline|Total|Total of all reporting groups
11122423|NCT01712178|FG000|Participant Flow|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
11122424|NCT01712178|FG001|Participant Flow|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
11122425|NCT01712178|OG000|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
11122426|NCT01712178|OG001|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
11122427|NCT01712178|EG000|Reported Event|New Formulation of Adalimumab 40 mg Every Other Week|
11122428|NCT01712178|EG001|Reported Event|Current Formulation Adalimumab 40 mg Every Other Week|
11122429|NCT01712204|BG000|Baseline|Placebo Capsule BID|Placebo Capsule BID for 16 Weeks
11122430|NCT01712204|BG001|Baseline|AC-201 50mg Capsule BID|AC-201 50mg Capsule BID for 16 Weeks
11122431|NCT01712204|BG002|Baseline|Total|Total of all reporting groups
11122432|NCT01712204|FG000|Participant Flow|Placebo|Placebo Capsule BID for 16 Weeks
11122433|NCT01712204|FG001|Participant Flow|AC-201|AC-201 50mg Capsule BID for 16 Weeks
11122434|NCT01712204|OG000|Outcome|Placebo|"Placebo Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
11122435|NCT01712204|OG001|Outcome|AC-201|"AC-201 50mg Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
11122436|NCT01712204|EG000|Reported Event|Placebo|"Placebo Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
11122437|NCT01712204|EG001|Reported Event|AC-201|"AC-201 50mg Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
11122438|NCT01712230|BG000|Baseline|Placebo|"Monthly placebo injections for 6 months~Placebo: Placebo"
11122439|NCT01712230|BG001|Baseline|GnRH Agonist|"Monthly GnRH agonist injections for 6 months~GnRH agonist: Drug: leuprolide acetate~Other Names:~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months"
11122440|NCT01712230|BG002|Baseline|GnRH Agonist + Exercise|"Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention~GnRH agonist: Drug: leuprolide acetate~Other Names:~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months~Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months"
11122441|NCT01712230|BG003|Baseline|Total|Total of all reporting groups
11122442|NCT01712230|FG000|Participant Flow|Placebo|"Monthly placebo injections for 6 months~Placebo: Placebo"
11122443|NCT01712230|FG001|Participant Flow|GnRH Agonist|"Monthly GnRH agonist injections for 6 months~GnRH agonist: Drug: leuprolide acetate~Other Names:~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months"
11122444|NCT01712230|FG002|Participant Flow|GnRH Agonist + Exercise|"Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention~GnRH agonist: Drug: leuprolide acetate~Other Names:~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months~Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months"
11122445|NCT01712230|OG000|Outcome|Placebo|"Monthly placebo injections for 6 months~Placebo: Placebo"
11122446|NCT01712230|OG001|Outcome|GnRH Agonist|"Monthly GnRH agonist injections for 6 months~GnRH agonist: Drug: leuprolide acetate~Other Names:~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months"
11122447|NCT01712230|OG002|Outcome|GnRH Agonist + Exercise|"Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention~GnRH agonist: Drug: leuprolide acetate~Other Names:~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months~Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months"
11122448|NCT01712230|EG000|Reported Event|Placebo|"Monthly placebo injections for 6 months~Placebo: Placebo"
11122449|NCT01712230|EG001|Reported Event|GnRH Agonist|"Monthly GnRH agonist injections for 6 months~GnRH agonist: Drug: leuprolide acetate~Other Names:~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months"
11122450|NCT01712230|EG002|Reported Event|GnRH Agonist + Exercise|"Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention~GnRH agonist: Drug: leuprolide acetate~Other Names:~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months~Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months"
11122451|NCT01712256|BG000|Baseline|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
11122452|NCT01712256|FG000|Participant Flow|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
11122453|NCT01712256|OG000|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
11122454|NCT01712256|EG000|Reported Event|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
11122455|NCT01712334|BG000|Baseline|All Participants|All participants received dornase alfa (Pulmozyme) inhaled once daily by the Pari eRapid nebulizer or the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then crossed over to use the other nebulizer in Treatment Period 2 for 2 weeks.
11122456|NCT01712334|FG000|Participant Flow|eRapid Nebulizer Then Jet Nebulizer|"Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 2.~."
11348471|NCT04173429|BG000|Baseline|Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group|"Nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months.~Nadroparin calciumsubcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3."
11348472|NCT04173429|BG001|Baseline|Control Group|No anticoagulation therapy.
11348473|NCT04173429|BG002|Baseline|Total|Total of all reporting groups
11122457|NCT01712334|FG001|Participant Flow|Jet Nebulizer Then eRapid Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 2.
11122458|NCT01712334|OG000|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
11122459|NCT01712334|OG001|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
11122460|NCT01712334|EG000|Reported Event|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
11122461|NCT01712334|EG001|Reported Event|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
11122462|NCT01712360|BG000|Baseline|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
11122463|NCT01712360|BG001|Baseline|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
11122464|NCT01712360|BG002|Baseline|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
11122465|NCT01712360|BG003|Baseline|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
11122466|NCT01712360|BG004|Baseline|Total|Total of all reporting groups
11122467|NCT01712360|FG000|Participant Flow|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
11122468|NCT01712360|FG001|Participant Flow|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
11122469|NCT01712360|FG002|Participant Flow|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
11122470|NCT01712360|FG003|Participant Flow|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
11122471|NCT01712360|OG000|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
11122472|NCT01712360|OG001|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
11122473|NCT01712360|OG002|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
11122474|NCT01712360|OG003|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
11122475|NCT01712360|OG000|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
11122476|NCT01712360|OG001|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
11122477|NCT01712360|OG002|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
11122478|NCT01712360|OG003|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
11122479|NCT01712360|OG004|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
11122480|NCT01712360|OG005|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
11122481|NCT01712360|EG000|Reported Event|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
11122482|NCT01712360|EG001|Reported Event|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
11122483|NCT01712360|EG002|Reported Event|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
11122484|NCT01712360|EG003|Reported Event|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
11122485|NCT01712399|BG000|Baseline|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
11122486|NCT01712399|FG000|Participant Flow|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
11122487|NCT01712399|OG000|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
11122488|NCT01712399|EG000|Reported Event|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
11122489|NCT01712438|BG000|Baseline|Human-cl rhFVIII|The safety (SAF) and intent-to-treat (ITT) population consists all patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
11122490|NCT01712438|FG000|Participant Flow|Human-cl rhFVIII|"Of the total number of patients that started in the study, the safety (SAF) and intent-to-treat (ITT) population received at least one treatment with Human-cl rhFVIII.~Prophylactic treatment dose given to all patients in the PROPH population (all patients who received at least one administration of Human cI rhFVIII with prophylaxis documented as the reason for treatment): 20-50 IU/FVIII/kg body weight (BW)).~On-demand treatment of bleeding episodes (BEs) dose given to the BLEED population (all patients with bleeding episodes treated with Human cI rhFVIII): 20-30 IU FVIII/kg BW (minor haemorrhage), 30-40 IU FVIII/kg BW (moderate to major haemorrhage) or 40-60 IU FVIII/kg BW (major to life-threatening haemorrhage). Surgical prophylaxis dose given to the SURG population (all patients with surgeries performed under Human cI rhFVIII treatment): 25-30 IU FVIII/kg BW (minor surgeries) or 40-60 IU FVIII/kg BW (major surgeries)."
11122491|NCT01712438|OG000|Outcome|SAF/ITT Population|All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
11122492|NCT01712438|OG000|Outcome|PROPH Population|All patients who received at least one prophylactic treatment with Human-cl rhFVIII (n=103).
11122493|NCT01712438|OG000|Outcome|BLEED Population|All patients that experienced at least one bleeding episode that was treated with Human-cl rhFVIII (n=94).
11122494|NCT01712438|OG000|Outcome|Minor Surgeries|All patients that had minor surgeries performed under Human-cl rhFVIII treatment (n=13)
11122495|NCT01712438|OG001|Outcome|Major Surgeries|All patients that had major surgeries performed under Human-cl rhFVIII treatment (n=11)
11122496|NCT01712438|OG002|Outcome|All Surgeries|All patients that had surgeries performed under Human-cl rhFVIII treatment (n=24)
11122497|NCT01712438|EG000|Reported Event|SAF/ITT Population|All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
11122498|NCT01712516|BG000|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
11122499|NCT01712516|BG001|Baseline|QAB149|27.5 ug b.i.d.
11122500|NCT01712516|BG002|Baseline|NVA237|12.5 ug b.i.d.
11122501|NCT01712516|BG003|Baseline|Placebo|b.i.d.
11122502|NCT01712516|BG004|Baseline|Total|Total of all reporting groups
11122503|NCT01712516|FG000|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
11122504|NCT01712516|FG001|Participant Flow|QAB149|27.5 ug b.i.d.
11122505|NCT01712516|FG002|Participant Flow|NVA237|12.5 ug b.i.d.
11122506|NCT01712516|FG003|Participant Flow|Placebo|b.i.d.
11122507|NCT01712516|OG000|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
11122508|NCT01712516|OG001|Outcome|QAB149|27.5 ug b.i.d.
11122509|NCT01712516|OG002|Outcome|NVA237|12.5 ug b.i.d.
11122510|NCT01712516|OG003|Outcome|Placebo|b.i.d.
11122511|NCT01712516|EG000|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
11122512|NCT01712516|EG001|Reported Event|QAB149|27.5 ug b.i.d.
11122513|NCT01712516|EG002|Reported Event|NVA237|12.5 ug b.i.d.
11122514|NCT01712516|EG003|Reported Event|Placebo|b.i.d.
11122515|NCT01712685|BG000|Baseline|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
11122516|NCT01712685|FG000|Participant Flow|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
11122517|NCT01712685|OG000|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
11122518|NCT01712685|EG000|Reported Event|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
11126850|NCT01736085|FG005|Participant Flow|Counseling Plus Patches|"Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling~Nicotine patches: Subjects will receive nicotine patches directly sent to their home.~Subj"
11126851|NCT01736085|OG000|Outcome|Usual Care|no provision of free nicotine replacement therapy (NRT)
11126852|NCT01736085|OG001|Outcome|Voucher|Free nicotine replacement through a voucher system
11126853|NCT01736085|OG002|Outcome|Patches|nicotine replacement sent directly
11126854|NCT01736085|EG000|Reported Event|Material Group|Subjects will receive self-help materials
11126855|NCT01736085|EG001|Reported Event|Materials Plus Voucher|"Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches~Voucher: Subjects will receive a voucher for nicotine patches.~Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date."
11126856|NCT01736085|EG002|Reported Event|Materials Plus Patches|"Subjects will receive self-help materials and a 2 week's worth of nicotine patches~Nicotine patches: Subjects will receive nicotine patches directly sent to their home.~Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date."
11126857|NCT01736085|EG003|Reported Event|Counseling|"Subjects will receive up to 5 sessions of telephone counseling~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling"
11126858|NCT01736085|EG004|Reported Event|Counseling Plus Voucher|"Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling~Voucher: Subjects will receive a voucher for nicotine patches.~Subjects ra"
11336514|NCT03567382|BG001|Baseline|Low-risk Mothers|"Mothers with low risk HBV (defined as a viral load <10^6 and negative HBeAg) will not receive tenofovir disoproxil fumarate therapy during or after pregnancy. Their infants will still receive monovalent HBV vaccine within 24 hours of life.~Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life."
11336515|NCT03567382|BG002|Baseline|Total|Total of all reporting groups
11122519|NCT01712711|BG000|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
11122520|NCT01712711|BG001|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
11122521|NCT01712711|BG002|Baseline|Total|Total of all reporting groups
11122522|NCT01712711|FG000|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
11122523|NCT01712711|FG001|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
11122524|NCT01712711|OG000|Outcome|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
11122525|NCT01712711|OG001|Outcome|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
11122526|NCT01712711|EG000|Reported Event|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
11122527|NCT01712711|EG001|Reported Event|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
11122528|NCT01712776|BG000|Baseline|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
11122529|NCT01712776|BG001|Baseline|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
11122530|NCT01712776|BG002|Baseline|Total|Total of all reporting groups
11122531|NCT01712776|FG000|Participant Flow|Placebo (Normal Saline, Nature&Apos;s Tears)|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
11122532|NCT01712776|FG001|Participant Flow|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
11122533|NCT01712776|OG000|Outcome|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
11122534|NCT01712776|OG001|Outcome|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
11122535|NCT01712776|EG000|Reported Event|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
11122536|NCT01712776|EG001|Reported Event|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
11122537|NCT01712984|BG000|Baseline|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
11122538|NCT01712984|BG001|Baseline|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
11122539|NCT01712984|BG002|Baseline|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
11122540|NCT01712984|BG003|Baseline|Total|Total of all reporting groups
11122541|NCT01712984|FG000|Participant Flow|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
11122542|NCT01712984|FG001|Participant Flow|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
11122543|NCT01712984|FG002|Participant Flow|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
11122544|NCT01712984|OG000|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
11122545|NCT01712984|OG001|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
11122546|NCT01712984|OG002|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
11122547|NCT01712984|EG000|Reported Event|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
11122548|NCT01712984|EG001|Reported Event|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
11122549|NCT01712984|EG002|Reported Event|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
11224521|NCT02360488|BG001|Baseline|In-Clinic Therapy|"The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education.~In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions."
11122550|NCT01713036|BG000|Baseline|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
11122551|NCT01713036|FG000|Participant Flow|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [mcgCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
11122552|NCT01713036|OG000|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
11122553|NCT01713036|OG000|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
11122554|NCT01713036|OG000|Outcome|Pimasertib|Part A: For assessment of mass balance, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
11122555|NCT01713036|OG000|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
11122556|NCT01713036|OG000|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
11122557|NCT01713036|OG000|Outcome|Pimasertib|Part B : Subjects received 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
11122558|NCT01713036|OG000|Outcome|Pimasertib|Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [μCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
11122559|NCT01713036|EG000|Reported Event|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the IV tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 μCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
11122560|NCT01713283|BG000|Baseline|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
11122561|NCT01713283|BG001|Baseline|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
11122562|NCT01713283|BG002|Baseline|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
11122563|NCT01713283|BG003|Baseline|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
11122564|NCT01713283|BG004|Baseline|Total|Total of all reporting groups
11122565|NCT01713283|FG000|Participant Flow|SOF+RBV 12 Wk|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
11122566|NCT01713283|FG001|Participant Flow|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11122567|NCT01713283|OG000|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
11122568|NCT01713283|OG001|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
11122569|NCT01713283|OG002|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
11122570|NCT01713283|OG003|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
11122571|NCT01713283|OG000|Outcome|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
11122572|NCT01713283|OG001|Outcome|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11122573|NCT01713283|EG000|Reported Event|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
11122574|NCT01713283|EG001|Reported Event|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11122575|NCT01713348|BG000|Baseline|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
11122576|NCT01713348|BG001|Baseline|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
11122577|NCT01713348|BG002|Baseline|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
11122578|NCT01713348|BG003|Baseline|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
11122579|NCT01713348|BG004|Baseline|Total|Total of all reporting groups
11122580|NCT01713348|FG000|Participant Flow|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
11122581|NCT01713348|FG001|Participant Flow|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
11122582|NCT01713348|FG002|Participant Flow|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
11122583|NCT01713348|FG003|Participant Flow|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
11122584|NCT01713348|OG000|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
11122585|NCT01713348|OG001|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
11122586|NCT01713348|OG002|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
11122587|NCT01713348|OG003|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
11122588|NCT01713348|EG000|Reported Event|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
11122589|NCT01713348|EG001|Reported Event|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
11122590|NCT01713348|EG002|Reported Event|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
11122591|NCT01713348|EG003|Reported Event|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
11122592|NCT01713400|BG000|Baseline|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
11122593|NCT01713400|BG001|Baseline|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
11122594|NCT01713400|BG002|Baseline|Total|Total of all reporting groups
11224522|NCT02360488|BG002|Baseline|Total|Total of all reporting groups
11122595|NCT01713400|FG000|Participant Flow|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
11122596|NCT01713400|FG001|Participant Flow|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
11122597|NCT01713400|OG000|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
11122598|NCT01713400|OG001|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
11122599|NCT01713400|EG000|Reported Event|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
11122600|NCT01713400|EG001|Reported Event|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
11122601|NCT01713530|BG000|Baseline|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
11122602|NCT01713530|BG001|Baseline|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
11122603|NCT01713530|BG002|Baseline|Total|Total of all reporting groups
11348474|NCT04173429|FG000|Participant Flow|Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group|Nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months Nadroparin calcium, warfarin: Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
11348475|NCT04173429|FG001|Participant Flow|Control Group|No anticoagulation therapy.
11122604|NCT01713530|FG000|Participant Flow|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
11122605|NCT01713530|FG001|Participant Flow|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
11122606|NCT01713530|OG000|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
11122607|NCT01713530|OG001|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
11122608|NCT01713530|EG000|Reported Event|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
11122609|NCT01713530|EG001|Reported Event|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
11122610|NCT01713582|BG000|Baseline|AL 10 mg QD 14-21|Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
11122611|NCT01713582|BG001|Baseline|AL 20 mg QD 14-21|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122612|NCT01713582|BG002|Baseline|AL 40 mg QD 14-21|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122613|NCT01713582|BG003|Baseline|AL 20 mg BID 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122614|NCT01713582|BG004|Baseline|AL 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122615|NCT01713582|BG005|Baseline|AL 40 mg BID 14-21|Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
11122616|NCT01713582|BG006|Baseline|AL 120 mg QD 14-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122617|NCT01713582|BG007|Baseline|AL 120 mg QD 21-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122618|NCT01713582|BG008|Baseline|AL 160 mg QD 14-21|Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122619|NCT01713582|BG009|Baseline|AML de Novo 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122620|NCT01713582|BG010|Baseline|AML/MDS 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122621|NCT01713582|BG011|Baseline|OHM 10 mg QD 21-21|Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122622|NCT01713582|BG012|Baseline|OHM 20 mg QD 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122623|NCT01713582|BG013|Baseline|OHM 40 mg QD 21-21|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122624|NCT01713582|BG014|Baseline|OHM 80 mg QD 21-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122625|NCT01713582|BG015|Baseline|OHM 40 mg BID 21-21|Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122626|NCT01713582|BG016|Baseline|OHM 120 mg QD 21-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122627|NCT01713582|BG017|Baseline|OHM 120 mg QD 14-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122628|NCT01713582|BG018|Baseline|OHM 120 mg QD 5-7|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
11122629|NCT01713582|BG019|Baseline|OHM 120 mg QD 7-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
11122630|NCT01713582|BG020|Baseline|OHM/DLBCL 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122631|NCT01713582|BG021|Baseline|Total|Total of all reporting groups
11122632|NCT01713582|FG000|Participant Flow|AL 10 mg QD 14-21|Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
11122633|NCT01713582|FG001|Participant Flow|AL 20 mg QD 14-21|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
10878749|NCT00454142|OG000|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
10878750|NCT00454142|OG000|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
10878751|NCT00454142|OG000|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
10878752|NCT00454142|EG000|Reported Event|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
10878753|NCT00454181|BG000|Baseline|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
10878754|NCT00454181|BG001|Baseline|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
10878755|NCT00454181|BG002|Baseline|Total|Total of all reporting groups
10878756|NCT00454181|FG000|Participant Flow|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
10878757|NCT00454181|FG001|Participant Flow|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
10878758|NCT00454181|OG000|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
10878759|NCT00454181|OG001|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
10878760|NCT00454181|EG000|Reported Event|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
10878761|NCT00454181|EG001|Reported Event|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
10878762|NCT00454194|BG000|Baseline|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
10878763|NCT00454194|BG001|Baseline|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
10878764|NCT00454194|BG002|Baseline|Total|Total of all reporting groups
10878765|NCT00454194|FG000|Participant Flow|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
10878766|NCT00454194|FG001|Participant Flow|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
10878767|NCT00454194|OG000|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
11122634|NCT01713582|FG002|Participant Flow|AL 40 mg QD 14-21|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122635|NCT01713582|FG003|Participant Flow|AL 20 mg BID 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122636|NCT01713582|FG004|Participant Flow|AL 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122637|NCT01713582|FG005|Participant Flow|AL 40 mg BID 14-21|Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
11122638|NCT01713582|FG006|Participant Flow|AL 120 mg QD 14-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122639|NCT01713582|FG007|Participant Flow|AL 120 mg QD 21-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122640|NCT01713582|FG008|Participant Flow|AL 160 mg QD 14-21|Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122641|NCT01713582|FG009|Participant Flow|AML de Novo 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122642|NCT01713582|FG010|Participant Flow|AML/MDS 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122643|NCT01713582|FG011|Participant Flow|OHM 10 mg QD 21-21|Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122644|NCT01713582|FG012|Participant Flow|OHM 20 mg QD 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122645|NCT01713582|FG013|Participant Flow|OHM 40 mg QD 21-21|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122646|NCT01713582|FG014|Participant Flow|OHM 80 mg QD 21-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122647|NCT01713582|FG015|Participant Flow|OHM 40 mg BID 21-21|Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122648|NCT01713582|FG016|Participant Flow|OHM 120 mg QD 21-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122649|NCT01713582|FG017|Participant Flow|OHM 120 mg QD 14-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
10878768|NCT00454194|OG001|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
10878769|NCT00454194|EG000|Reported Event|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
10878770|NCT00454194|EG001|Reported Event|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
10878771|NCT00454207|BG000|Baseline|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878772|NCT00454207|BG001|Baseline|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
11122650|NCT01713582|FG018|Participant Flow|OHM 120 mg QD 5-7|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
11122651|NCT01713582|FG019|Participant Flow|OHM 120 mg QD 7-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
11122652|NCT01713582|FG020|Participant Flow|OHM/DLBCL 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122653|NCT01713582|OG000|Outcome|AL 10 mg QD 14-21|Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
11122654|NCT01713582|OG001|Outcome|AL 20 mg QD 14-21|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122655|NCT01713582|OG002|Outcome|AL 40 mg QD 14-21|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122656|NCT01713582|OG003|Outcome|AL 20 mg BID 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122657|NCT01713582|OG004|Outcome|AL 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122658|NCT01713582|OG005|Outcome|AL 40 mg BID 14-21|Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
11122659|NCT01713582|OG006|Outcome|AL 120 mg QD 14-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122660|NCT01713582|OG007|Outcome|AL 120 mg QD 21-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122661|NCT01713582|OG008|Outcome|AL 160 mg QD 14-21|Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122662|NCT01713582|OG009|Outcome|AML de Novo 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122663|NCT01713582|OG010|Outcome|AML/MDS 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122664|NCT01713582|OG011|Outcome|OHM 10 mg QD 21-21|Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
10878773|NCT00454207|BG002|Baseline|Total|Total of all reporting groups
11122665|NCT01713582|OG012|Outcome|OHM 20 mg QD 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122666|NCT01713582|OG013|Outcome|OHM 40 mg QD 21-21|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122667|NCT01713582|OG014|Outcome|OHM 80 mg QD 21-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122668|NCT01713582|OG015|Outcome|OHM 40 mg BID 21-21|Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122669|NCT01713582|OG016|Outcome|OHM 120 mg QD 21-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122670|NCT01713582|OG017|Outcome|OHM 120 mg QD 14-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122671|NCT01713582|OG018|Outcome|OHM 120 mg QD 5-7|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
11122672|NCT01713582|OG019|Outcome|OHM 120 mg QD 7-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
11122673|NCT01713582|OG020|Outcome|OHM/DLBCL 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122674|NCT01713582|OG000|Outcome|AL 10 mg QD 14-21|Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122675|NCT01713582|OG003|Outcome|AL 20 mg BID 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122676|NCT01713582|OG000|Outcome|10 mg QD Dose Escalation Cohort|Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state.
11122677|NCT01713582|OG001|Outcome|20 mg QD Dose Escalation Cohort|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state.
11122678|NCT01713582|OG002|Outcome|40 mg QD Dose Escalation Cohort|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state.
11122679|NCT01713582|OG003|Outcome|20 mg BID Dose Escalation Cohort|Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.
11122680|NCT01713582|OG004|Outcome|80 mg QD Dose Escalation Cohort|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.
11122681|NCT01713582|OG005|Outcome|40 mg BID Dose Escalation Cohort|Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.
11122682|NCT01713582|OG006|Outcome|120 mg QD Dose Escalation Cohort|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state.
11122683|NCT01713582|OG007|Outcome|160 mg QD Dose Escalation Cohort|Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state.
11122684|NCT01713582|OG008|Outcome|80 mg QD Expansion Cohort|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.
11122685|NCT01713582|OG000|Outcome|10 mg QD Dose Escalation Cohort|Participants received 10 mg MK-8628/OTX015 administered PO, QD in a fasted state.
11122686|NCT01713582|OG008|Outcome|80 mg QD Expansion Cohort|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state..
11122687|NCT01713582|OG002|Outcome|40 mg QD Dose Escalation Cohort|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state..
11122688|NCT01713582|EG000|Reported Event|AL 10 mg QD 14-21|Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
11122689|NCT01713582|EG001|Reported Event|AL 20 mg QD 14-21|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122690|NCT01713582|EG002|Reported Event|AL 40 mg QD 14-21|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122691|NCT01713582|EG003|Reported Event|AL 20 mg BID 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122692|NCT01713582|EG004|Reported Event|AL 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122693|NCT01713582|EG005|Reported Event|AL 40 mg BID 14-21|Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
11122694|NCT01713582|EG006|Reported Event|AL 120 mg QD 14-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122695|NCT01713582|EG007|Reported Event|AL 120 mg QD 21-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122696|NCT01713582|EG008|Reported Event|AL 160 mg QD 14-21|Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122697|NCT01713582|EG009|Reported Event|AML de Novo 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122698|NCT01713582|EG010|Reported Event|AML/MDS 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122699|NCT01713582|EG011|Reported Event|OHM 10 mg QD 21-21|Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122700|NCT01713582|EG012|Reported Event|OHM 20 mg QD 21-21|Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122701|NCT01713582|EG013|Reported Event|OHM 40 mg QD 21-21|Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122702|NCT01713582|EG014|Reported Event|OHM 40 mg BID 21-21|Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
11122703|NCT01713582|EG015|Reported Event|OHM 120 mg QD 21-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122704|NCT01713582|EG016|Reported Event|OHM 120 mg QD 14-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122705|NCT01713582|EG017|Reported Event|OHM 120 mg QD 5-7|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
11122706|NCT01713582|EG018|Reported Event|OHM 120 mg QD 7-21|Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
11122707|NCT01713582|EG019|Reported Event|OHM/DLBCL 80 mg QD 14-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
11122708|NCT01713582|EG020|Reported Event|OHM 80 mg QD 21-21|Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
11122709|NCT01713608|BG000|Baseline|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
11122710|NCT01713608|BG001|Baseline|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
11122711|NCT01713608|BG002|Baseline|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
11122712|NCT01713608|BG003|Baseline|Placebo|Placebo to match OZ439 PIB for oral suspension
11122713|NCT01713608|BG004|Baseline|Total|Total of all reporting groups
11122714|NCT01713608|FG000|Participant Flow|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
11122715|NCT01713608|FG001|Participant Flow|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
11122716|NCT01713608|FG002|Participant Flow|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
11122717|NCT01713608|FG003|Participant Flow|Placebo|Placebo to match OZ439 PIB for oral suspension
11122718|NCT01713608|OG000|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
11122719|NCT01713608|OG001|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
11122720|NCT01713608|OG002|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
11122721|NCT01713608|EG000|Reported Event|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
11122722|NCT01713608|EG001|Reported Event|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
11122723|NCT01713608|EG002|Reported Event|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
11122724|NCT01713608|EG003|Reported Event|Placebo|Placebo to match OZ439 PIB for oral suspension
11122725|NCT01713621|BG000|Baseline|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
11122726|NCT01713621|BG001|Baseline|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
11122727|NCT01713621|BG002|Baseline|Total|Total of all reporting groups
11122728|NCT01713621|FG000|Participant Flow|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
11122729|NCT01713621|FG001|Participant Flow|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
11122730|NCT01713621|OG000|Outcome|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
11122731|NCT01713621|OG001|Outcome|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
11122732|NCT01713621|EG000|Reported Event|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
11122733|NCT01713621|EG001|Reported Event|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
11122734|NCT01713660|BG000|Baseline|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
11122735|NCT01713660|FG000|Participant Flow|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
11122736|NCT01713660|OG000|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
11122737|NCT01713660|EG000|Reported Event|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
11122738|NCT01713686|BG000|Baseline|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
11122739|NCT01713686|FG000|Participant Flow|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
11122740|NCT01713686|OG000|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
11122741|NCT01713686|EG000|Reported Event|Ulthera System Treatment|"A single triple depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
11122742|NCT01713868|BG000|Baseline|Safe Sleep Edu and Breastfeeding mHealth|"Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging~Safe Sleep Nursery Education: Nursery-based program for safe sleep~Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email."
11122743|NCT01713868|BG001|Baseline|Breastfeeding Edu and Safe Sleep mHealth|"Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging~Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding~Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email."
11122744|NCT01713868|BG002|Baseline|Safe Sleep Edu and Safe Sleep mHealth|"Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging~Safe Sleep Nursery Education: Nursery-based program for safe sleep~Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email."
11122745|NCT01713868|BG003|Baseline|Breastfeed Edu and Breastfeed mHealth|"Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging~Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding~Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email."
11122746|NCT01713868|BG004|Baseline|Total|Total of all reporting groups
11122747|NCT01713868|FG000|Participant Flow|Safe Sleep Edu and Breastfeeding mHealth|"Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging~Safe Sleep Nursery Education: Nursery-based program for safe sleep~Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email."
11122748|NCT01713868|FG001|Participant Flow|Breastfeeding Edu and Safe Sleep mHealth|"Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging~Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding~Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email."
11122749|NCT01713868|FG002|Participant Flow|Safe Sleep Edu and Safe Sleep mHealth|"Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging~Safe Sleep Nursery Education: Nursery-based program for safe sleep~Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email."
11122750|NCT01713868|FG003|Participant Flow|Breastfeed Edu and Breastfeed mHealth|"Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging~Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding~Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email."
11122751|NCT01713868|OG000|Outcome|Safe Sleep Edu and Breastfeeding mHealth|"Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging~Safe Sleep Nursery Education: Nursery-based program for safe sleep~Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email."
11122752|NCT01713868|OG001|Outcome|Breastfeeding Edu and Safe Sleep mHealth|"Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging~Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding~Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email."
11122753|NCT01713868|OG002|Outcome|Safe Sleep Edu and Safe Sleep mHealth|"Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging~Safe Sleep Nursery Education: Nursery-based program for safe sleep~Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email."
11122754|NCT01713868|OG003|Outcome|Breastfeed Edu and Breastfeed mHealth|"Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging~Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding~Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email."
11122755|NCT01713868|OG000|Outcome|Control|Received mHealth breastfeeding
11122756|NCT01713868|OG001|Outcome|mHealth Safe Sleep|Received mHealth safe sleep
11122757|NCT01713868|EG000|Reported Event|Safe Sleep Edu and Breastfeeding mHealth|"Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging~Safe Sleep Nursery Education: Nursery-based program for safe sleep~Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email."
11122758|NCT01713868|EG001|Reported Event|Breastfeeding Edu and Safe Sleep mHealth|"Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging~Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding~Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email."
11122759|NCT01713868|EG002|Reported Event|Safe Sleep Edu and Safe Sleep mHealth|"Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging~Safe Sleep Nursery Education: Nursery-based program for safe sleep~Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email."
11122760|NCT01713868|EG003|Reported Event|Breastfeed Edu and Breastfeed mHealth|"Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging~Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding~Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email."
11122761|NCT01713933|BG000|Baseline|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
11122762|NCT01713933|FG000|Participant Flow|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
11122763|NCT01713933|OG000|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
11122764|NCT01713933|EG000|Reported Event|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
11122765|NCT01713946|BG000|Baseline|Everolimus LT Target of 3 to 7 ng/mL|Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
11122766|NCT01713946|BG001|Baseline|Everolimus HT Target of 9 to 15 ng/mL|Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
11122767|NCT01713946|BG002|Baseline|Placebo|Participants were randomized to receive placebo dispersible tablets for oral suspension.
11122768|NCT01713946|BG003|Baseline|Total|Total of all reporting groups
11122769|NCT01713946|FG000|Participant Flow|Everolimus LT Target of 3 to 7 ng/mL|Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
11122770|NCT01713946|FG001|Participant Flow|Everolimus HT Target of 9 to 15 ng/mL|Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
11348476|NCT04173429|OG000|Outcome|Nadroparin Calcium-warfarin Sequential Therapy Group|"nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months~Low molecular weight heparin (LMWH), warfarin: Low molecular weight heparin subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months(LMWH-warfarin group). INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3."
11348477|NCT04173429|OG001|Outcome|Control Group|No anticoagulation therapy.
10845268|NCT00266032|FG002|Participant Flow|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
11122771|NCT01713946|FG002|Participant Flow|Placebo|Participants who received placebo dispersible tablets for oral suspension at study start and switched to everolimus in Extension.
11122772|NCT01713946|OG000|Outcome|Everolimus LT Target of 3 to 7 ng/mL|Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
11122773|NCT01713946|OG001|Outcome|Everolimus HT Target of 9 to 15 ng/mL|Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
11122774|NCT01713946|OG002|Outcome|Placebo|Participants were randomized to receive placebo dispersible tablets for oral suspension.
11122775|NCT01713946|OG003|Outcome|Everolimus Long Term Evaluation (LTE)|Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.
11122776|NCT01713946|OG000|Outcome|<3 ng/mL|Observed TN-Cmin concentration during the maintenance of the core phase: <3 ng/mL
11122777|NCT01713946|OG001|Outcome|3-7 ng/mL|Observed TN-Cmin concentration during the maintenance of the core phase:3 - 7 ng/mL
11122778|NCT01713946|OG002|Outcome|>7-<9 ng/mL|Observed TN-Cmin concentration during the maintenance of the core phase: >7 - <9 ng/mL
11122779|NCT01713946|OG003|Outcome|9-15 ng/mL|Observed TN-Cmin concentration during the maintenance of the core phase: 9 - 15 ng/mL
11122780|NCT01713946|OG004|Outcome|>15 ng/mL|Observed TN-Cmin concentration during the maintenance of the core phase: >15 ng/mL
11122781|NCT01713946|OG000|Outcome|Valporic Acid|Antiepileptic drug
11122782|NCT01713946|OG001|Outcome|Carbamazepine|antiepileptic drug
11122783|NCT01713946|OG002|Outcome|Clobazam|antiepileptic drug
11122784|NCT01713946|OG003|Outcome|N-desmethylclobazam|antiepileptic drug
11122785|NCT01713946|OG004|Outcome|Topiramate|antiepileptic drug
11122786|NCT01713946|OG005|Outcome|TRI477|antiepileptic drug
11122787|NCT01713946|OG006|Outcome|TRI476|antiepileptic drug
11122788|NCT01713946|OG007|Outcome|Clonazepam|antiepileptic drug
11122789|NCT01713946|OG008|Outcome|Zonisamide|antiepileptic drug
11122790|NCT01713946|OG009|Outcome|Phenobarbital|antiepileptic drug
11122791|NCT01713946|OG010|Outcome|Phenytoin|antiepileptic drug
11122792|NCT01713946|EG000|Reported Event|Everolimus LT Target of 3 to 7 ng/mL|Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
11122793|NCT01713946|EG001|Reported Event|Everolimus HT Target of 9 to 15 ng/mL|Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
11122794|NCT01713946|EG002|Reported Event|Everolimus Start Ext|Participants who received placebo dispersible tablets for oral suspension at study start and switched to everolimus in Extension.
11122795|NCT01713946|EG003|Reported Event|Everolimus All|Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.
11122796|NCT01713998|BG000|Baseline|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
11122797|NCT01713998|BG001|Baseline|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
11348478|NCT04173429|OG000|Outcome|Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group|Nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months Nadroparin calcium, warfarin: Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
11122798|NCT01713998|BG002|Baseline|Group C|Subjects received Ultherapy® treatment using standard (highest) energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer used at the second highest energy setting on one side of the upper face and the 7-4.5mm transducer at the standard (highest) energy setting on the contralateral side of the upper face.
11122799|NCT01713998|BG003|Baseline|Total|Total of all reporting groups
11122800|NCT01713998|FG000|Participant Flow|Group A|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face.
11122801|NCT01713998|FG001|Participant Flow|Group B|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face.
11122802|NCT01713998|FG002|Participant Flow|Group C|Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face.
11122803|NCT01713998|OG000|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
11122804|NCT01713998|OG001|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
11122805|NCT01713998|OG002|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
11122806|NCT01713998|OG002|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted) second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7 MHz transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4 MHz transducer at the second highest energy setting and the corresponding lower face side.
11122807|NCT01713998|OG002|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
11122808|NCT01713998|EG000|Reported Event|Study Population|Includes all subjects meeting entrance criteria, consented for participation, enrolled and randomized.
11122809|NCT01714024|BG000|Baseline|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122810|NCT01714024|BG001|Baseline|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122811|NCT01714024|BG002|Baseline|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122812|NCT01714024|BG003|Baseline|Total|Total of all reporting groups
11122813|NCT01714024|FG000|Participant Flow|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122814|NCT01714024|FG001|Participant Flow|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122815|NCT01714024|FG002|Participant Flow|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122816|NCT01714024|OG000|Outcome|Healthy/Tantalum|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
11122817|NCT01714024|OG001|Outcome|Healthy/Titanium|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
11122818|NCT01714024|OG002|Outcome|Osteopenic/Tantalum|"Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
11122819|NCT01714024|OG003|Outcome|Osteopenic/Titanium|"Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
11122820|NCT01714024|OG004|Outcome|Diabetic/Tantalum|"Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
11122821|NCT01714024|OG005|Outcome|Diabetic/Titanium|"Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
11122822|NCT01714024|OG000|Outcome|Healthy Tantalum|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122823|NCT01714024|OG001|Outcome|Heathy Titanium|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122824|NCT01714024|OG002|Outcome|Diabetic Tantalum|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks"
11122825|NCT01714024|OG003|Outcome|Diabetic Titanium|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122826|NCT01714024|OG004|Outcome|Osteoporosis Tantalum|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122827|NCT01714024|OG005|Outcome|Osteoporosis Titanium|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122828|NCT01714024|EG000|Reported Event|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122829|NCT01714024|EG001|Reported Event|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122830|NCT01714024|EG002|Reported Event|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
11122831|NCT01714063|BG000|Baseline|All Study Participants|All participants that were consented to the study were considered.
11122832|NCT01714063|FG000|Participant Flow|Pressurized Metered-Dose Inhaler|All participants that were consented to use the Pressurized Metered-Dose Inhaler in this study were considered.
11122833|NCT01714063|OG000|Outcome|Age 5-6.5|"Group 1 will consist of 16 children aged 5-6.5 years~Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler"
11122834|NCT01714063|OG001|Outcome|Aged 6.6- 8 Years|"Group 2 will consist of 16 children aged 6.6- 8 years~Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler"
11122835|NCT01714063|OG000|Outcome|All Participants|Data among all participants were compared for the coordinated and uncoordinated effort
11122836|NCT01714063|OG000|Outcome|Coordinated Effort|Data among all participants were compared for the coordinated maneuver.
11122837|NCT01714063|OG001|Outcome|Uncoordinated Effort|Data among all participants were compared for the uncoordinated maneuver.
11122838|NCT01714063|EG000|Reported Event|All Study Participants|All participants that were consented to the study were considered.
11122839|NCT01714232|BG000|Baseline|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
11122840|NCT01714232|FG000|Participant Flow|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
11122841|NCT01714232|OG000|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
11122842|NCT01714232|EG000|Reported Event|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
11122843|NCT01714310|BG000|Baseline|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 3.
11122844|NCT01714310|BG001|Baseline|Fluoxetine|Randomized participants who competed open-label lisdexamfetamine titration from baseline through week 3, who continued to meet eligibility criteria, and then proceeded to adjunctive fluoxetine therapy from week 4 through week 12.
11122845|NCT01714310|BG002|Baseline|Placebo|Randomized participants who competed open-label lisdexamfetamine titration from baseline through week 3, who continued to meet eligibility criteria, and then proceeded to adjunctive placebo from week 4 through week 12.
11122846|NCT01714310|BG003|Baseline|Total|Total of all reporting groups
11122847|NCT01714310|FG000|Participant Flow|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.
11122848|NCT01714310|FG001|Participant Flow|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.
11122849|NCT01714310|FG002|Participant Flow|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing to the end of study week 4.
11122850|NCT01714310|OG000|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
11122851|NCT01714310|OG001|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
11122852|NCT01714310|OG002|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
11122853|NCT01714310|OG000|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at end of study week 4 6 continuing through week 12.
11122854|NCT01714310|OG001|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at end of study week 4 and continuing through week.
11122855|NCT01714310|OG002|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine at study visits 2-6.
11122856|NCT01714310|OG000|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing tp week 12.
11122857|NCT01714310|OG001|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 and continuing through week 12.
11122858|NCT01714310|OG002|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
11122859|NCT01714310|OG002|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through week 4.
11122860|NCT01714310|OG001|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 though week 12.
11122861|NCT01714310|OG000|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.
11122862|NCT01714310|OG001|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.
11122863|NCT01714310|EG000|Reported Event|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 and continuing though week 12.
11122864|NCT01714310|EG001|Reported Event|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through week 12.
11122865|NCT01714310|EG002|Reported Event|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 4.
11122866|NCT01714323|BG000|Baseline|Standard Care|"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.~Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."
11122867|NCT01714323|BG001|Baseline|Sustained Care|"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.~Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."
11122868|NCT01714323|BG002|Baseline|Total|Total of all reporting groups
11122869|NCT01714323|FG000|Participant Flow|Standard Care|"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.~Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."
11122870|NCT01714323|FG001|Participant Flow|Sustained Care|"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.~Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."
11348479|NCT04173429|EG000|Reported Event|Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group|Nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months Nadroparin calcium, warfarin: Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
11122871|NCT01714323|OG000|Outcome|Standard Care|"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.~Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."
11122872|NCT01714323|OG001|Outcome|Sustained Care|"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.~Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."
11122873|NCT01714323|EG000|Reported Event|Standard Care|"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.~Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."
11122874|NCT01714323|EG001|Reported Event|Sustained Care|"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.~Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."
11122875|NCT01714336|BG000|Baseline|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
11122876|NCT01714336|BG001|Baseline|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
11122877|NCT01714336|BG002|Baseline|Total|Total of all reporting groups
11122878|NCT01714336|FG000|Participant Flow|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
11122879|NCT01714336|FG001|Participant Flow|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
11122880|NCT01714336|OG000|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
11122881|NCT01714336|OG001|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
11122882|NCT01714336|EG000|Reported Event|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
11122883|NCT01714336|EG001|Reported Event|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
11122884|NCT01714492|BG000|Baseline|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
10848774|NCT00291447|OG003|Outcome|Cohort 4|"Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11122885|NCT01714492|FG000|Participant Flow|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
11122886|NCT01714492|OG000|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
11122887|NCT01714492|OG000|Outcome|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
11122888|NCT01714492|EG000|Reported Event|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
11122889|NCT01714505|BG000|Baseline|Open and Closed Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.~Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
11122890|NCT01714505|FG000|Participant Flow|Open-Loop Then Closed-Loop Control|"Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings.~Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia."
11122891|NCT01714505|FG001|Participant Flow|Closed-Loop Then Open-Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.~Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
11122892|NCT01714505|OG000|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
11122893|NCT01714505|OG001|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
11122894|NCT01714505|EG000|Reported Event|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
11122895|NCT01714505|EG001|Reported Event|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
11122896|NCT01714544|BG000|Baseline|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
11122897|NCT01714544|FG000|Participant Flow|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
11122898|NCT01714544|OG000|Outcome|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
11122899|NCT01714544|EG000|Reported Event|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
11122900|NCT01714609|BG000|Baseline|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
11122901|NCT01714609|BG001|Baseline|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
11122902|NCT01714609|BG002|Baseline|Total|Total of all reporting groups
11122903|NCT01714609|FG000|Participant Flow|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
11122904|NCT01714609|FG001|Participant Flow|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
11122905|NCT01714609|OG000|Outcome|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
11122906|NCT01714609|OG001|Outcome|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
11122907|NCT01714609|EG000|Reported Event|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
11122908|NCT01714609|EG001|Reported Event|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
11122909|NCT01714635|BG000|Baseline|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
11122910|NCT01714635|BG001|Baseline|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
11122911|NCT01714635|BG002|Baseline|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
11122912|NCT01714635|BG003|Baseline|Total|Total of all reporting groups
11122913|NCT01714635|FG000|Participant Flow|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
11122914|NCT01714635|FG001|Participant Flow|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
11122915|NCT01714635|FG002|Participant Flow|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
11122916|NCT01714635|OG000|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
11122917|NCT01714635|OG001|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
11122918|NCT01714635|OG002|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
11122919|NCT01714635|EG000|Reported Event|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
11122920|NCT01714635|EG001|Reported Event|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
11122921|NCT01714635|EG002|Reported Event|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
11122922|NCT01714687|BG000|Baseline|Balloon Sinus Dilation|Subjects treated with balloon sinus dilation
11122923|NCT01714687|BG001|Baseline|Medical Therapy|Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
11122924|NCT01714687|BG002|Baseline|Total|Total of all reporting groups
11122925|NCT01714687|FG000|Participant Flow|Balloon Sinus Dilation|Subjects treated with balloon sinus dilation
11122926|NCT01714687|FG001|Participant Flow|Medical Therapy|Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
11122927|NCT01714687|OG000|Outcome|Balloon Sinus Dilation|Subjects treated with balloon sinus dilation
11122928|NCT01714687|OG001|Outcome|Medical Therapy|Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
11122929|NCT01714687|OG000|Outcome|Medical Therapy|Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
11122930|NCT01714687|OG001|Outcome|Balloon Sinus Dilation|Subjects treated with balloon sinus dilation
11122931|NCT01714687|EG000|Reported Event|Balloon Sinus Dilation|Subjects treated with balloon sinus dilation
11122932|NCT01714687|EG001|Reported Event|Medical Therapy|Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
11122933|NCT01714726|BG000|Baseline|Placebo|Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
11122934|NCT01714726|BG001|Baseline|Experimental: MEDI2070 700mg|Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
11122935|NCT01714726|BG002|Baseline|Total|Total of all reporting groups
11122936|NCT01714726|FG000|Participant Flow|Placebo|Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
11122937|NCT01714726|FG001|Participant Flow|Experimental: MEDI2070 700mg|Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
11122938|NCT01714726|FG002|Participant Flow|Placebo/MEDI2070 210mg|Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
11122939|NCT01714726|FG003|Participant Flow|MEDI2070 700mg/MEDI2070 210mg|Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
11122940|NCT01714726|OG000|Outcome|Placebo|Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
11122941|NCT01714726|OG001|Outcome|Experimental: MEDI2070 700mg|Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
11348480|NCT04173429|EG001|Reported Event|Control Group|No anticoagulation therapy.
11122942|NCT01714726|OG002|Outcome|Placebo/MEDI2070 210mg|Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
11122943|NCT01714726|OG003|Outcome|MEDI2070 700mg/MEDI2070 210mg|Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
11122944|NCT01714726|EG000|Reported Event|Placebo|Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
11122945|NCT01714726|EG001|Reported Event|Experimental: MEDI2070 700mg|Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
11122946|NCT01714726|EG002|Reported Event|Placebo/MEDI2070 210mg|Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
11122947|NCT01714726|EG003|Reported Event|MEDI2070 700mg/MEDI2070 210mg|Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
11122948|NCT01714804|BG000|Baseline|Prospective|"Accell Evo3~Accell Evo3 prospective study arm"
11122949|NCT01714804|BG001|Baseline|Retrospective|"Infuse~rh-BMP2 retrospective study arm"
11122950|NCT01714804|BG002|Baseline|Total|Total of all reporting groups
11122951|NCT01714804|FG000|Participant Flow|Accell Evo3|Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
11122952|NCT01714804|FG001|Participant Flow|Infuse|Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space. Subjects in this treatment arm were historical controls and were not enrolled in this study.
11122953|NCT01714804|OG000|Outcome|Accell Evo3|Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 to S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
11122954|NCT01714804|OG001|Outcome|Infuse|Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 to S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.
11122955|NCT01714804|OG000|Outcome|Accell Evo3|Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
11122956|NCT01714804|OG001|Outcome|Infuse|Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space. Subjects in this treatment arm were historical controls and were not enrolled in this study.
11122957|NCT01714804|EG000|Reported Event|Accell Evo3|Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
11122958|NCT01714804|EG001|Reported Event|Infuse|Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.
11122959|NCT01714921|BG000|Baseline|ICD Patients|Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product
11122960|NCT01714921|FG000|Participant Flow|ICD Patients (Single Arm Study)|Patients with an indication for an Implantable Cardioverter/Defibrillator (ICD) implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product
11122961|NCT01714921|OG000|Outcome|ICD Patients (Single Arm Study)|Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product
11122962|NCT01714921|OG000|Outcome|ICD Patients|Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product
11122963|NCT01714921|EG000|Reported Event|ICD Patients (Single Arm Study)|Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product
11122964|NCT01714947|BG000|Baseline|Alisertib|Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).
11122965|NCT01714947|FG000|Participant Flow|Alisertib|Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).
11122966|NCT01714947|OG000|Outcome|Alisertib|Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).
11122967|NCT01714947|EG000|Reported Event|Alisertib|Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).
11122968|NCT01715064|BG000|Baseline|Control|non-exercise control consisting of movie watching.
11122969|NCT01715064|BG001|Baseline|Exercise|1 hour of moderate intensity exercise.
11122970|NCT01715064|BG002|Baseline|Total|Total of all reporting groups
11122971|NCT01715064|FG000|Participant Flow|Control (1hr of Viewing Emotionally Neutral Movie)|non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral.
11122972|NCT01715064|FG001|Participant Flow|Exercise (1hr of Mixed-modality Exercise)|1 hour of moderate intensity exercise. The session included 5- min warm-up, 25-min of resistance training, 25-min of aerobic training, and 5-min cool-down. Each session was led by a personal trainer and supervised by an exercise physiologist.
11122973|NCT01715064|OG000|Outcome|Control|non-exercise control consisting of movie watching.
11122974|NCT01715064|OG001|Outcome|Exercise|1 hour of moderate intensity exercise.
11122975|NCT01715064|EG000|Reported Event|Control|non-exercise control consisting of movie watching.
11122976|NCT01715064|EG001|Reported Event|Exercise|1 hour of moderate intensity exercise.
11122977|NCT01715129|BG000|Baseline|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
11122978|NCT01715129|FG000|Participant Flow|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
11122979|NCT01715129|OG000|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
11122980|NCT01715129|EG000|Reported Event|Triptorelin Pamoate 11.25 mg|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
11122981|NCT01715207|BG000|Baseline|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
11122982|NCT01715207|BG001|Baseline|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
11122983|NCT01715207|BG002|Baseline|Total|Total of all reporting groups
11122984|NCT01715207|FG000|Participant Flow|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
11122985|NCT01715207|FG001|Participant Flow|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
11122986|NCT01715207|OG000|Outcome|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
11122987|NCT01715207|OG001|Outcome|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
11122988|NCT01715207|OG000|Outcome|Atenolol and Aliskiren|Aliskiren (Norvatis) 300mg oral tablet
11122989|NCT01715207|OG001|Outcome|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Control group baseline 24 Weeks Central PWV (m/s)(26) by MRI regional PWV A (level 1-2) 3.8 (1.7) 3.6 (1.23) PWV-total (level 1-4) 5.0 (1.03) 4.9 (1.24)"
11122990|NCT01715207|EG000|Reported Event|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Treatment (n=14) Overall rate of adverse events 12 (85.7%) moderate to severe cases 0 generalized symptoms 8 (57.1%) gastrointestinal symptoms 4 (28.6%) lung problems 0 cardiovascular symptoms 3 (21.4%) central nervous system symptoms 5 (35.7%) Eye, nose, throat symptoms 4 (28.6%) gynecologic problems 1 (7.1%) problems of extremities 1 (7.1%)"
11122991|NCT01715207|EG001|Reported Event|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Control (n=14) Overall rate of adverse events 10 (71.4%) moderate to severe cases 2 (14.3%) generalized symptoms 4 (28.6%) gastrointestinal symptoms 3 (21.4%) lung problems 1 (7.1%) cardiovascular symptoms 0 central nervous system symptoms 1 (7.1%) Eye, nose, throat symptoms 1 (7.1%) gynecologic problems 1 (7.1%) problems of extremities 2 (14.3%)"
11122992|NCT01715233|BG000|Baseline|Metastatic Esophageal, Gastroesophageal & Gastric Cancer|"Participants receive modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.~Docetaxel: Modified Docetaxel 40mg/m2 on Day 1~Leucovorin: Leucovorin 400mg/m2 on Day 1~Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2~Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3"
11122993|NCT01715233|FG000|Participant Flow|Metastatic Esophageal, Gastroesophageal & Gastric Cancer|"Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.~Docetaxel: Modified Docetaxel 40mg/m2 on Day 1~Leucovorin: Leucovorin 400mg/m2 on Day 1~Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2~Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3"
11122994|NCT01715233|OG000|Outcome|Metastatic Esophageal, Gastroesophageal & Gastric Cancer.|"Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.~Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3"
11122995|NCT01715233|OG000|Outcome|Metastatic Esophageal, Gastroesophageal And Gastric Cancer.|"Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.~Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3"
11122996|NCT01715233|EG000|Reported Event|Metastatic Esophageal, Gastroesophageal & Gastric Cancer|"Patients received modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.~Docetaxel: Modified Docetaxel 40mg/m2 on Day 1~Leucovorin: Leucovorin 400mg/m2 on Day 1~Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2~Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3"
11122997|NCT01715298|BG000|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11122998|NCT01715298|BG001|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11122999|NCT01715298|BG002|Baseline|Total|Total of all reporting groups
11123000|NCT01715298|FG000|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11123001|NCT01715298|FG001|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11123002|NCT01715298|OG000|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11123003|NCT01715298|OG001|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11123004|NCT01715298|EG000|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11348481|NCT04173741|BG000|Baseline|Group A|"Patients who stayed in passive leg rise position for 3 minutes~USG measurement: IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done."
11348482|NCT04173741|BG001|Baseline|Group B|"Patients who stayed in passive leg rise position for 1 minute~USG measurement: IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done."
11348483|NCT04173741|BG002|Baseline|Total|Total of all reporting groups
11123005|NCT01715298|EG001|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
11123006|NCT01715415|BG000|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
11123007|NCT01715415|BG001|Baseline|Placebo|Double-blind placebo for 12 weeks
11123008|NCT01715415|BG002|Baseline|Total|Total of all reporting groups
11123009|NCT01715415|FG000|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
11123010|NCT01715415|FG001|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
11123011|NCT01715415|OG000|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
11123012|NCT01715415|OG001|Outcome|Placebo|Double-blind placebo for 12 weeks
11123013|NCT01715415|EG000|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
11123014|NCT01715415|EG001|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
11123015|NCT01715415|EG002|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
11348484|NCT04173741|FG000|Participant Flow|Leg Rise Position - 3 Minutes|"Patients who stayed in passive leg rise position for 3 minutes~Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done."
11123016|NCT01715571|BG000|Baseline|Viberect Treatment|Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
11123017|NCT01715571|FG000|Participant Flow|Viberect Treatment|Single-center, non-randomized, single-arm study The Viberect device was used for 7-10 minutes at least 3 times each week, at least 24 hours apart, 4 weeks period
11123018|NCT01715571|OG000|Outcome|Viberect Treatment|Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
11123019|NCT01715571|EG000|Reported Event|Viberect Treatment|Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
11123020|NCT01715805|BG000|Baseline|Placebo + ADT Lead-in|Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
11123021|NCT01715805|FG000|Participant Flow|Placebo + ADT Lead-in|Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
11123022|NCT01715805|FG001|Participant Flow|Placebo + ADT (Double-Blind)|Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
11123023|NCT01715805|FG002|Participant Flow|Cariprazine + ADT (Double-Blind)|Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
11123024|NCT01715805|FG003|Participant Flow|Placebo + ADT (Continued Treatment)|Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.
11123025|NCT01715805|OG000|Outcome|Placebo + ADT (Double-Blind)|Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
11123026|NCT01715805|OG001|Outcome|Cariprazine + ADT (Double-Blind)|Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
11123027|NCT01715805|EG000|Reported Event|Placebo + ADT Lead-in|Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
11123028|NCT01715805|EG001|Reported Event|Placebo + ADT (Double-Blind)|Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
11123029|NCT01715805|EG002|Reported Event|Cariprazine + ADT (Double-Blind)|Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
11123030|NCT01715805|EG003|Reported Event|Placebo + ADT (Continued Treatment)|Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.
11123031|NCT01715831|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
10848775|NCT00291447|OG001|Outcome|Cohort 2|"Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806:ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11123032|NCT01715831|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
11123033|NCT01715831|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
11123034|NCT01715831|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
11123035|NCT01715857|BG000|Baseline|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
11123036|NCT01715857|FG000|Participant Flow|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
11123037|NCT01715857|OG000|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
11123038|NCT01715857|EG000|Reported Event|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
11123039|NCT01715883|BG000|Baseline|Sodium Nitrite|"Sodium Nitrite will be administered at three time points:~At the time of organ procurement, a pre-prepared syringe of sodium nitrite will be added to each of the 2.8 Liter bags of Perfadex solution to flush the donor lungs.~At the time of transplant just prior to reperfusion of lungs, , the donor lungs are flushed with a cold pneumoplegia solution after the bronchial (1st) anastomosis and with warm pneumoplegia solution after the portal vein (3rd, last) anastomosis. The drug will be added to pneumoplegia solution just prior to both the flushes.~Sodium Nitrite will be delivered intravenously to the recipient immediately prior to lung reperfusion as a single infusion at rate of 4 mL/min for the first 30 min, followed by 2.2 mL/min for the next 60 min.~Sodium Nitrite: Same as the details in Arm Description."
11123040|NCT01715883|FG000|Participant Flow|Sodium Nitrite|"Sodium Nitrite will be administered at three time points:~At the time of organ procurement, a pre-prepared syringe of sodium nitrite will be added to each of the 2.8 Liter bags of Perfadex solution to flush the donor lungs.~At the time of transplant just prior to reperfusion of lungs, , the donor lungs are flushed with a cold pneumoplegia solution after the bronchial (1st) anastomosis and with warm pneumoplegia solution after the portal vein (3rd, last) anastomosis. The drug will be added to pneumoplegia solution just prior to both the flushes.~Sodium Nitrite will be delivered intravenously to the recipient immediately prior to lung reperfusion as a single infusion at rate of 4 mL/min for the first 30 min, followed by 2.2 mL/min for the next 60 min.~Sodium Nitrite: Same as the details in Arm Description."
11123041|NCT01715883|OG000|Outcome|Sodium Nitrite|"Sodium Nitrite will be administered at three time points:~At the time of organ procurement, a pre-prepared syringe of sodium nitrite will be added to each of the 2.8L bags of Perfadex solution to flush the donor lungs.~At the time of transplant just prior to reperfusion of lungs, , the donor lungs are flushed with a cold pneumoplegia solution after the bronchial (1st) anastomosis and with warm pneumoplegia solution after the PV (3rd, last) anastomosis. The drug will be added to pneumoplegia solution just prior to both the flushes.~Sodium Nitrite will be delivered intravenously to the recipient immediately prior to lung reperfusion as a single infusion at rate of 4 mL/min for the first 30 min, followed by 2.2 mL/min for the next 60 min.~Sodium Nitrite: Same as the details in Arm Description."
11123042|NCT01715883|OG000|Outcome|Sodium Nitrite|"Sodium Nitrite will be administered at three time points:~At the time of organ procurement, a pre-prepared syringe of sodium nitrite will be added to each of the 2.8L bags of Perfadex solution to flush the donor lungs.~At the time of transplant just prior to reperfusion of lungs, the donor lungs are flushed with a cold pneumoplegia solution after the bronchial (1st) anastomosis and with warm pneumoplegia solution after the PV (3rd, last) anastomosis. The drug will be added to pneumoplegia solution just prior to both the flushes.~Sodium Nitrite will be delivered intravenously to the recipient immediately prior to lung reperfusion as a single infusion at rate of 4 mL/min for the first 30 min, followed by 2.2 mL/min for the next 60 min.~Sodium Nitrite: Same as the details in Arm Description."
11123043|NCT01715883|EG000|Reported Event|Sodium Nitrite|"Sodium Nitrite will be administered at three time points:~At the time of organ procurement, a pre-prepared syringe of sodium nitrite will be added to each of the 2.8L bags of Perfadex solution to flush the donor lungs.~At the time of transplant just prior to reperfusion of lungs, , the donor lungs are flushed with a cold pneumoplegia solution after the bronchial (1st) anastomosis and with warm pneumoplegia solution after the PV (3rd, last) anastomosis. The drug will be added to pneumoplegia solution just prior to both the flushes.~Sodium Nitrite will be delivered intravenously to the recipient immediately prior to lung reperfusion as a single infusion at rate of 4 mL/min for the first 30 min, followed by 2.2 mL/min for the next 60 min.~Sodium Nitrite: Same as the details in Arm Description."
11123044|NCT01715896|BG000|Baseline|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123045|NCT01715896|BG001|Baseline|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123046|NCT01715896|BG002|Baseline|Total|Total of all reporting groups
11123047|NCT01715896|FG000|Participant Flow|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123048|NCT01715896|FG001|Participant Flow|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123049|NCT01715896|OG000|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123050|NCT01715896|OG001|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123051|NCT01715896|OG000|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123052|NCT01715896|EG000|Reported Event|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123053|NCT01715896|EG001|Reported Event|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
11123054|NCT01715948|BG000|Baseline|A Comparison Between Wireless CROS and BAHD for SSD|"Participants who have been implanted with a BAHD over the past three years will be given a two-week trial period with a CROS hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.~CROS hearing aid: BAHD users will be fitted with the CROS hearing aid for a two-week trial period. Their hearing abilities with the CROS hearing aid will be compared to their hearing abilities with their BAHD over a two-week period."
11123055|NCT01715948|FG000|Participant Flow|Contralateral Routing of Signals (CROS) Hearing Aid|"Participants who have been implanted with a bone-anchored hearing device (BAHD) over the past three years will be given a two-week trial period with a Contralateral Routing of Signals (CROS) hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.~Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries."
11123056|NCT01715948|OG000|Outcome|QuickSIN Noise to Better Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.
11123057|NCT01715948|OG001|Outcome|QuickSIN Noise to Better Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.
11123058|NCT01715948|OG002|Outcome|QuickSIN Noise to Better Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.
11123059|NCT01715948|OG003|Outcome|QuickSIN Noise to Poorer Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.
11123060|NCT01715948|OG004|Outcome|QuickSIN Noise to Poorer Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.
11123061|NCT01715948|OG005|Outcome|QuickSIN Noise to Poorer Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.
11123062|NCT01715948|OG000|Outcome|WRS Noise to Better Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the better ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
11123063|NCT01715948|OG001|Outcome|WRS Noise to Poorer Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
11123064|NCT01715948|OG002|Outcome|WRS in Quiet to Poorer Ear|Word recognition was tested with no noise (quiet) with words presented at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
11123065|NCT01715948|OG000|Outcome|SSQ Subscale - Speech (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
11123066|NCT01715948|OG001|Outcome|SSQ Subscale - Speech (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
11123067|NCT01715948|OG002|Outcome|SSQ Subscale - Spatial (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
11123068|NCT01715948|OG003|Outcome|SSQ Subscale - Spatial (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
11123069|NCT01715948|OG004|Outcome|SSQ Subscale - Qualities (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
11123070|NCT01715948|OG005|Outcome|SSQ Subscale - Qualities (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
11123071|NCT01715948|EG000|Reported Event|BAHD|The intervention during which the BAHD was trialed as part of the cross-over design
11123072|NCT01715948|EG001|Reported Event|CROS Aid|The intervention during which the CROS aid was trialed as part of the cross-over design
11123073|NCT01716013|BG000|Baseline|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
11123074|NCT01716013|BG001|Baseline|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
11123075|NCT01716013|BG002|Baseline|Total|Total of all reporting groups
11123076|NCT01716013|FG000|Participant Flow|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
11123077|NCT01716013|FG001|Participant Flow|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
11123078|NCT01716013|OG000|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
11123079|NCT01716013|OG001|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
11123080|NCT01716013|EG000|Reported Event|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
11123081|NCT01716013|EG001|Reported Event|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
11123082|NCT01716039|BG000|Baseline|Placebo|"Participants randomized to receive placebo at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123083|NCT01716039|BG001|Baseline|MTX 12.5 mg|"Participants randomized to receive Methotrexate 12.5 mg at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab:18 weekly doses of adalimumab"
11123084|NCT01716039|BG002|Baseline|MTX 25 mg|"Participants randomized to receive Methotrexate 25.0 mg at Week 00 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123085|NCT01716039|BG003|Baseline|Total|Total of all reporting groups
11123086|NCT01716039|FG000|Participant Flow|Placebo|"Participants randomized to receive placebo at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123087|NCT01716039|FG001|Participant Flow|MTX 12.5 mg|"Participants randomized to receive Methotrexate 12.5 mg at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
10846075|NCT00272961|BG004|Baseline|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
10846076|NCT00272961|BG005|Baseline|Total|Total of all reporting groups
11123088|NCT01716039|FG002|Participant Flow|MTX 25 mg|"Participants randomized to receive Methotrexate 25.0 mg at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123089|NCT01716039|OG000|Outcome|Placebo|"Participants randomized to receive placebo at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks.~Adalimumab: 18 weekly doses of adalimumab"
11123090|NCT01716039|OG001|Outcome|MTX 12.5mg|"Participants randomized to receive Methotrexate 12.5 mg at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks.~Adalimumab: 18 weekly doses of adalimumab"
11123091|NCT01716039|OG002|Outcome|MTX 25 mg|"Participants randomized to receive Methotrexate 25.0 mg at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123092|NCT01716039|OG001|Outcome|MTX 12.5 mg|"Participants randomized to receive Methotrexate 12.5 mg at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123093|NCT01716039|OG002|Outcome|MTX 25 mg|"Participants randomized to receive Methotrexate 25.0 mg at Week 0(two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123094|NCT01716039|EG000|Reported Event|Placebo|"Participants randomized to receive placebo at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123095|NCT01716039|EG001|Reported Event|MTX 12.5 mg|"Participants randomized to receive Methotrexate 12.5 mg at Week 0 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab: 18 weekly doses of adalimumab"
11123096|NCT01716039|EG002|Reported Event|MTX 25 mg|"Participants randomized to receive Methotrexate 25.0 mg at Week 00 (two weeks prior to the initiation of adalimumab induction therapy) and then every week for 18 weeks~Adalimumab:18 weekly doses of adalimumab"
11123097|NCT01716104|BG000|Baseline|Afalaza|Afalaza (2 tablets twice a day): Safety and Efficiency
11123098|NCT01716104|BG001|Baseline|Placebo|Placebo (2 tablets twice a day): Safety and Efficiency
11123099|NCT01716104|BG002|Baseline|Total|Total of all reporting groups
11123100|NCT01716104|FG000|Participant Flow|Afalaza|"Afalaza (2 tablets twice a day) One tablet contains: affinity purified antibodies to endothelial nitric oxide synthase - 0.006g*, affinity purified antibodies to prostate-specific antigen - 0.006g*.~*applied onto isomalt crystals as a mixture of three active aqueous-alcoholic dilutions of the drug substance - diluted 100^12, 100^30, 100^50 times, respectively.~Excipients: lactose monohydrate; microcrystalline cellulose; magnesium stearate."
11123101|NCT01716104|FG001|Participant Flow|Placebo|Placebo (2 tablets twice a day)
11123102|NCT01716104|OG000|Outcome|Afalaza|Afalaza (2 tablets twice a day): Safety and Efficacy
11123103|NCT01716104|OG001|Outcome|Placebo|Placebo (2 tablets twice a day): Safety and Efficacy
11123104|NCT01716104|EG000|Reported Event|Afalaza|Afalaza (2 tablets twice a day): Safety and Efficiency
11123105|NCT01716104|EG001|Reported Event|Placebo|Placebo (2 tablets twice a day): Safety and Efficiency
11123106|NCT01716156|BG000|Baseline|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
11123107|NCT01716156|BG001|Baseline|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
11123108|NCT01716156|BG002|Baseline|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
11123109|NCT01716156|BG003|Baseline|Total|Total of all reporting groups
11123110|NCT01716156|FG000|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
11123111|NCT01716156|FG001|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
11123112|NCT01716156|FG002|Participant Flow|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
11123113|NCT01716156|OG000|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
11123114|NCT01716156|OG001|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
11123115|NCT01716156|OG000|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
11123116|NCT01716156|OG001|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
11123117|NCT01716156|OG000|Outcome|Grazoprevir 100 mg + RBV HCV GT1a|This group consisted of all participants with HCV GT1a infection pooled across treatment arms.
11123118|NCT01716156|OG001|Outcome|Grazoprevir 100 mg + RBV HCV GT1non-a|This group consisted of all participants with HCV GT1non-a infection, pooled across treatment arms.
10846077|NCT00272961|FG000|Participant Flow|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
11123119|NCT01716156|OG001|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
11123120|NCT01716156|OG002|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
11123121|NCT01716156|EG000|Reported Event|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
11123122|NCT01716156|EG001|Reported Event|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
11123123|NCT01716169|BG000|Baseline|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
11123124|NCT01716169|FG000|Participant Flow|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
11123125|NCT01716169|OG000|Outcome|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
11123126|NCT01716169|OG001|Outcome|Standard of Care Dressing - Chronic Wound|Standard of Care dressings will be applied to one chronic wound
11123127|NCT01716169|EG000|Reported Event|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
11123128|NCT01716169|EG001|Reported Event|Standard of Care - Chronic Wound|Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound.
11123129|NCT01716195|BG000|Baseline|Response Adapted Chemoradiation|"Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel~Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel."
11123130|NCT01716195|FG000|Participant Flow|Response Adapted Chemoradiation|"Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel~Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel."
11123131|NCT01716195|OG000|Outcome|Response Adapted Chemoradiation|"Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel~Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel."
11123132|NCT01716195|EG000|Reported Event|Response Adapted Chemoradiation|"Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel~Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel."
11123133|NCT01716208|BG000|Baseline|Ofatumumab + Fresh Frozen Plasma|"Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).~Ofatumumab + Fresh Frozen Plasma"
11123134|NCT01716208|FG000|Participant Flow|Ofatumumab + Fresh Frozen Plasma|"Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).~Ofatumumab + Fresh Frozen Plasma"
11123135|NCT01716208|OG000|Outcome|Ofatumumab + Fresh Frozen Plasma|"Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).~Ofatumumab + Fresh Frozen Plasma"
11123136|NCT01716208|EG000|Reported Event|Ofatumumab + Fresh Frozen Plasma|"Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).~Ofatumumab + Fresh Frozen Plasma"
11123137|NCT01716221|BG000|Baseline|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
11123138|NCT01716221|FG000|Participant Flow|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
11123139|NCT01716221|OG000|Outcome|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day or 50mg Bupropion & 10mg Citalopram taken orally one time per day~bupropion & Citalopram"
11123140|NCT01716221|OG001|Outcome|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day~Bupropion & Placebo"
11123141|NCT01716221|OG002|Outcome|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day~Placebo & Citalopram"
11123142|NCT01716221|OG003|Outcome|Placebo & Placebo|"Placebo & Placebo taken orally one time per day~Placebo & Placebo"
11123143|NCT01716221|OG004|Outcome|Baseline|unblinded 100mg Bupropion & 20mg Citalopram
11123144|NCT01716221|OG000|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
11123145|NCT01716221|OG001|Outcome|Citalopram (Week 5)|
11123146|NCT01716221|OG002|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
11123147|NCT01716221|OG003|Outcome|Bupropion Only (Week 15)|
11123148|NCT01716221|OG004|Outcome|Bupropion + Citalopram (Week 20)|
11123149|NCT01716221|EG000|Reported Event|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day~bupropion & Citalopram"
11123150|NCT01716221|EG001|Reported Event|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day~Bupropion & Placebo"
11123151|NCT01716221|EG002|Reported Event|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day~Placebo & Citalopram"
11123152|NCT01716221|EG003|Reported Event|Placebo & Placebo|"Placebo & Placebo taken orally one time per day~Placebo & Placebo"
11123153|NCT01716234|BG000|Baseline|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123154|NCT01716234|BG001|Baseline|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123155|NCT01716234|BG002|Baseline|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123156|NCT01716234|BG003|Baseline|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123157|NCT01716234|BG004|Baseline|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123158|NCT01716234|BG005|Baseline|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123159|NCT01716234|BG006|Baseline|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123160|NCT01716234|BG007|Baseline|Total|Total of all reporting groups
11123161|NCT01716234|FG000|Participant Flow|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123162|NCT01716234|FG001|Participant Flow|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123163|NCT01716234|FG002|Participant Flow|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123164|NCT01716234|FG003|Participant Flow|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123165|NCT01716234|FG004|Participant Flow|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123166|NCT01716234|FG005|Participant Flow|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123167|NCT01716234|FG006|Participant Flow|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123168|NCT01716234|OG000|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123169|NCT01716234|OG001|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123170|NCT01716234|OG002|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123171|NCT01716234|OG003|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123172|NCT01716234|OG004|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123173|NCT01716234|OG005|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123174|NCT01716234|OG006|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123175|NCT01716234|EG000|Reported Event|POS 12 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123176|NCT01716234|EG001|Reported Event|POS 12 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123177|NCT01716234|EG002|Reported Event|POS 18 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123178|NCT01716234|EG003|Reported Event|POS 18 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
11123179|NCT01716234|EG004|Reported Event|POS 18 TID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123180|NCT01716234|EG005|Reported Event|POS 18 TID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123181|NCT01716234|EG006|Reported Event|POS 12 TID 3 Months to <2 Yrs|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11123182|NCT01716455|BG000|Baseline|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123183|NCT01716455|BG001|Baseline|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123184|NCT01716455|BG002|Baseline|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123185|NCT01716455|BG003|Baseline|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123186|NCT01716455|BG004|Baseline|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123187|NCT01716455|BG005|Baseline|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123188|NCT01716455|BG006|Baseline|Total|Total of all reporting groups
11123189|NCT01716455|FG000|Participant Flow|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123190|NCT01716455|FG001|Participant Flow|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123191|NCT01716455|FG002|Participant Flow|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123192|NCT01716455|FG003|Participant Flow|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123193|NCT01716455|FG004|Participant Flow|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123194|NCT01716455|FG005|Participant Flow|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123195|NCT01716455|OG000|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123196|NCT01716455|OG001|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123197|NCT01716455|OG002|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123198|NCT01716455|OG003|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123199|NCT01716455|OG004|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123200|NCT01716455|OG005|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123201|NCT01716455|EG000|Reported Event|Impaired Renal Function|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123202|NCT01716455|EG001|Reported Event|Matched Healthy Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123203|NCT01716455|EG002|Reported Event|Healthy Elderly Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
11123204|NCT01716468|BG000|Baseline|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
11123205|NCT01716468|FG000|Participant Flow|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
11123206|NCT01716468|OG000|Outcome|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
11123207|NCT01716468|EG000|Reported Event|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
11123208|NCT01716520|BG000|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
11123209|NCT01716520|FG000|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
11123210|NCT01716520|FG001|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11123211|NCT01716520|FG002|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11123212|NCT01716520|FG003|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11123213|NCT01716520|FG004|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11123214|NCT01716520|FG005|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11123215|NCT01716520|OG000|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11123216|NCT01716520|OG001|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11123217|NCT01716520|OG002|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11123218|NCT01716520|EG000|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11123219|NCT01716520|EG001|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11123220|NCT01716520|EG002|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11123221|NCT01716533|BG000|Baseline|Recurrence Group|Male or female subjects aged 18 years or older at the time of enrolment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.
11123222|NCT01716533|BG001|Baseline|Sustained Response Group|Male or female subjects aged 18 years or older at the time of enrolment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
11123223|NCT01716533|BG002|Baseline|Failure to Antibiotic Group|Male or female subjects aged 18 years or older at the time of enrolment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.
11123224|NCT01716533|BG003|Baseline|Unclassified Group|Male or female subjects aged 18 years or older at the time of enrolment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.
11123225|NCT01716533|BG004|Baseline|Total|Total of all reporting groups
11123226|NCT01716533|FG000|Participant Flow|Recurrence Group|Male or female subjects aged 18 years or older at the time of enrolment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.
11123227|NCT01716533|FG001|Participant Flow|Sustained Response Group|Male or female subjects aged 18 years or older at the time of enrolment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
11123228|NCT01716533|FG002|Participant Flow|Failure to Antibiotic Group|Male or female subjects aged 18 years or older at the time of enrolment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.
11123229|NCT01716533|FG003|Participant Flow|Unclassified Group|Male or female subjects aged 18 years or older at the time of enrolment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.
11123230|NCT01716533|OG000|Outcome|Recurrence Group|Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.
11123231|NCT01716533|OG001|Outcome|Sustained Response Group|Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
11123232|NCT01716533|OG002|Outcome|Failure to Antibiotic Group|Male or female subjects aged 18 years or older at the time of enrolment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.
11123233|NCT01716533|OG003|Outcome|Unclassified Group|Male or female subjects aged 18 years or older at the time of enrollment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.
11123234|NCT01716533|OG000|Outcome|Recurrence Group|Male or female subjects aged 18 years or older at the time of enrolment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.
11123235|NCT01716533|OG001|Outcome|Sustained Response Group|Male or female subjects aged 18 years or older at the time of enrolment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
11123236|NCT01716533|OG003|Outcome|Unclassified Group|Male or female subjects aged 18 years or older at the time of enrolment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.
11123237|NCT01716533|OG002|Outcome|Failure to Antibiotic Group|Male or female subjects aged 18 years or older at the time of enrollment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.
11123238|NCT01716533|EG000|Reported Event|Recurrence Group|Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.
11123239|NCT01716533|EG001|Reported Event|Sustained Response Group|Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
11123240|NCT01716533|EG002|Reported Event|Failure to Antibiotic Group|Male or female subjects aged 18 years or older at the time of enrolment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.
11123241|NCT01716533|EG003|Reported Event|Unclassified Group|Male or female subjects aged 18 years or older at the time of enrolment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.
11123242|NCT01716559|BG000|Baseline|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
11123243|NCT01716559|FG000|Participant Flow|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta (NeoRecormon) subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
11123244|NCT01716559|OG000|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
11123245|NCT01716559|EG000|Reported Event|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
11123246|NCT01716585|BG000|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11123247|NCT01716585|BG001|Baseline|Placebo|Double-blind placebo for 12 weeks
11123248|NCT01716585|BG002|Baseline|Total|Total of all reporting groups
11123249|NCT01716585|FG000|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11123250|NCT01716585|FG001|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11123251|NCT01716585|OG000|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11123252|NCT01716585|OG001|Outcome|Placebo|Double-blind placebo for 12 weeks
11123253|NCT01716585|EG000|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11123254|NCT01716585|EG001|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
11123255|NCT01716585|EG002|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11123256|NCT01716663|BG000|Baseline|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
11123257|NCT01716663|FG000|Participant Flow|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
11123258|NCT01716663|OG000|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
11123259|NCT01716663|EG000|Reported Event|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
11123260|NCT01716715|BG000|Baseline|Cabozantinib|Cabozantinib 60 mg oral daily continously
11123261|NCT01716715|BG001|Baseline|Paclitaxel|Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
11123262|NCT01716715|BG002|Baseline|Total|Total of all reporting groups
11123263|NCT01716715|FG000|Participant Flow|Cabozantinib|Cabozantinib 60 mg oral daily continously
11123264|NCT01716715|FG001|Participant Flow|Paclitaxel|Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
11123265|NCT01716715|OG000|Outcome|Cabozantinib|Cabozantinib 60 mg oral daily continously
11123266|NCT01716715|OG001|Outcome|Paclitaxel|Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
11123267|NCT01716715|OG000|Outcome|Grade 3 and Above on Cabozantinib|Grade 3 and above toxicities for participants on Cabozantinib 60 mg oral daily continously
11123268|NCT01716715|OG001|Outcome|Grade 3 and Above on Paclitaxel|Grade 3 toxicities for participants on Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
11123269|NCT01716715|EG000|Reported Event|Cabozantinib|Cabozantinib 60 mg oral daily continously
11123270|NCT01716715|EG001|Reported Event|Paclitaxel|Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
11123271|NCT01716754|BG000|Baseline|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
11123272|NCT01716754|BG001|Baseline|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
11123273|NCT01716754|BG002|Baseline|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
11123274|NCT01716754|BG003|Baseline|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab.
11123275|NCT01716754|BG004|Baseline|Total|Total of all reporting groups
11123276|NCT01716754|FG000|Participant Flow|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
11123277|NCT01716754|FG001|Participant Flow|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
11123278|NCT01716754|FG002|Participant Flow|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
11123279|NCT01716754|FG003|Participant Flow|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab.
11123280|NCT01716754|OG000|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
11123281|NCT01716754|OG001|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
11123282|NCT01716754|OG002|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
11123283|NCT01716754|EG000|Reported Event|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
11123284|NCT01716754|EG001|Reported Event|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
11123285|NCT01716754|EG002|Reported Event|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
11123286|NCT01716754|EG003|Reported Event|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab
11123287|NCT01717001|BG000|Baseline|ConforMIS|Patients with ConforMIS implants
11123288|NCT01717001|BG001|Baseline|Standard Total Knee Implant|Patients implanted with standard total knee implant
11123289|NCT01717001|BG002|Baseline|Total|Total of all reporting groups
11123290|NCT01717001|FG000|Participant Flow|ConforMIS|Patients with ConforMIS implants
11123291|NCT01717001|FG001|Participant Flow|Standard Total Knee Implant|Patients implanted with standard total knee implant
11123292|NCT01717001|OG000|Outcome|ConforMIS|Patients with ConforMIS implants
11123293|NCT01717001|OG001|Outcome|Standard Total Knee Implant|Patients implanted with standard total knee implant
11123294|NCT01717001|EG000|Reported Event|ConforMIS|Patients with ConforMIS implants
11123295|NCT01717001|EG001|Reported Event|Standard Total Knee Implant|Patients implanted with standard total knee implant
11123296|NCT01717014|BG000|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
11123297|NCT01717014|FG000|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
11123298|NCT01717014|OG000|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
11123299|NCT01717014|EG000|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
11123300|NCT01717040|BG000|Baseline|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
11123301|NCT01717040|BG001|Baseline|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
11123302|NCT01717040|BG002|Baseline|Total|Total of all reporting groups
11123303|NCT01717040|FG000|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
11123304|NCT01717040|FG001|Participant Flow|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
11123305|NCT01717040|OG000|Outcome|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
11123306|NCT01717040|OG001|Outcome|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
11123307|NCT01717040|EG000|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
11123308|NCT01717040|EG001|Reported Event|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
11123309|NCT01717053|BG000|Baseline|Abiraterone+Radiotherapy+ADT|Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
11123310|NCT01717053|FG000|Participant Flow|Abiraterone+Radiotherapy+ADT|Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
11123311|NCT01717053|OG000|Outcome|Abiraterone+Radiotherapy+ADT|Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
11123312|NCT01717053|EG000|Reported Event|Abiraterone+Radiotherapy+ADT|Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
11123313|NCT01717209|BG000|Baseline|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
11123314|NCT01717209|FG000|Participant Flow|Combined Nitric Oxide and Prostacyclin|Inhaled nitric oxide (iNO; 20 ppm continuously) and inhaled prostacyclin (iPGI2; 0.05 micrograms/kg/min continuously)
11123315|NCT01717209|OG000|Outcome|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
11123316|NCT01717209|EG000|Reported Event|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
11123317|NCT01717287|BG000|Baseline|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
11123318|NCT01717287|BG001|Baseline|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
11123319|NCT01717287|BG002|Baseline|Total|Total of all reporting groups
11123320|NCT01717287|FG000|Participant Flow|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
11123321|NCT01717287|FG001|Participant Flow|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
11123322|NCT01717287|OG000|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
11123323|NCT01717287|OG001|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
11123324|NCT01717287|EG000|Reported Event|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
11123325|NCT01717287|EG001|Reported Event|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
11123326|NCT01717313|BG000|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
11123327|NCT01717313|BG001|Baseline|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
11123328|NCT01717313|BG002|Baseline|Total|Total of all reporting groups
11123329|NCT01717313|FG000|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
11123330|NCT01717313|FG001|Participant Flow|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
11123331|NCT01717313|OG000|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
11123332|NCT01717313|OG001|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
11123333|NCT01717313|EG000|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
11123334|NCT01717313|EG001|Reported Event|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
11123335|NCT01717326|BG000|Baseline|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123336|NCT01717326|BG001|Baseline|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123337|NCT01717326|BG002|Baseline|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123338|NCT01717326|BG003|Baseline|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123339|NCT01717326|BG004|Baseline|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123340|NCT01717326|BG005|Baseline|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123341|NCT01717326|BG006|Baseline|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123342|NCT01717326|BG007|Baseline|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123343|NCT01717326|BG008|Baseline|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123344|NCT01717326|BG009|Baseline|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
11123345|NCT01717326|BG010|Baseline|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123346|NCT01717326|BG011|Baseline|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11006170|NCT01084655|OG001|Outcome|Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
11006171|NCT01084655|OG002|Outcome|Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT).
11006172|NCT01084655|OG000|Outcome|Phase 2 Cycle 1: Docetaxel 75 mg/m^2 + Prednisone 5 mg|Docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of Treatment Cycle 1.
11006173|NCT01084655|OG001|Outcome|Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of Treatment Cycle 2.
11006174|NCT01084655|OG000|Outcome|Phase 2 Cycle 1: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel 400 mg, tablets, orally, BID, on Day 21 of Treatment Cycle 1 along with docetaxel 75 mg/m^2, injection, intravenously on Day 1 and prednisone 5 mg, tablets, orally, BID from Day 1 up to Day 21 of Treatment Cycle 1.
11006175|NCT01084655|OG000|Outcome|Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT).
11006176|NCT01084655|EG000|Reported Event|Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 200 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
11006177|NCT01084655|EG001|Reported Event|Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
11006178|NCT01084655|EG002|Reported Event|Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone|Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT).
11006179|NCT01084668|BG000|Baseline|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
11006180|NCT01084668|FG000|Participant Flow|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
11006181|NCT01084668|OG000|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
11006182|NCT01084668|OG000|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
11006183|NCT01084668|OG001|Outcome|Subgroup With Nail Psoriasis|Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
11006184|NCT01084668|EG000|Reported Event|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
11006185|NCT01084694|BG000|Baseline|Autologous Transplant|50 pairs of autologous patients and their caregivers were enrolled
11006186|NCT01084694|BG001|Baseline|Allogeneic Transplant|50 pairs of allogeneic patients and their caregivers were enrolled
11006187|NCT01084694|BG002|Baseline|Total|Total of all reporting groups
11006188|NCT01084694|FG000|Participant Flow|Patients Undergoing Autologous Transplant|50% of patients enrolled in this study will be undergoing autologous transplant with one primary caregiver.
11006189|NCT01084694|FG001|Participant Flow|Patients Undergoing Allogeneic Transplant|50% of patients enrolled in this study will be undergoing allogeneic transplant with one primary caregiver.
11006190|NCT01084694|OG000|Outcome|Autologous Transplant Recipients|patients receiving autologous transplant
11006191|NCT01084694|OG001|Outcome|Allogeneic Transplant Recipients|patients receiving allogeneic transplants
11006192|NCT01084694|OG000|Outcome|Autologous Transplant Recipients|patients receiving an autologous transplant
11006193|NCT01084694|OG001|Outcome|Allogeneic Transplant Recipients|Patients receiving an allogeneic transplant
11006194|NCT01084694|OG000|Outcome|Autologous Transplant Recipients|Patients receiving autologous transplant
11006195|NCT01084694|OG001|Outcome|Allogeneic Transplant Recipients|Patients receiving allogeneic transplants
11006196|NCT01084694|OG000|Outcome|Caregivers for Autologous Transplant Recipients|Caregivers of patients who had autologous transplants
11006197|NCT01084694|OG001|Outcome|Caregivers for Allogeneic Transplant Recipients|Caregivers for patients who were receiving an allogeneic transplant
11006198|NCT01084694|EG000|Reported Event|Patients Undergoing Autologous Transplant|Patients undergoing autologous transplant
11006199|NCT01084694|EG001|Reported Event|Patients Undergoing Allogeneic Transplant|Patients undergoing allogeneic transplant
11006200|NCT01084694|EG002|Reported Event|Caregivers for Patients Undergoing Autologous Transplant|Caregivers for patients undergoing autologous transplant. Only emotional distress was monitored for the caregivers.
11123347|NCT01717326|BG012|Baseline|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123348|NCT01717326|BG013|Baseline|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
11123349|NCT01717326|BG014|Baseline|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123350|NCT01717326|BG015|Baseline|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123351|NCT01717326|BG016|Baseline|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123352|NCT01717326|BG017|Baseline|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
11123353|NCT01717326|BG018|Baseline|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123354|NCT01717326|BG019|Baseline|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123355|NCT01717326|BG020|Baseline|Total|Total of all reporting groups
11123356|NCT01717326|FG000|Participant Flow|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123357|NCT01717326|FG001|Participant Flow|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123358|NCT01717326|FG002|Participant Flow|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123359|NCT01717326|FG003|Participant Flow|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123360|NCT01717326|FG004|Participant Flow|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123361|NCT01717326|FG005|Participant Flow|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123362|NCT01717326|FG006|Participant Flow|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123363|NCT01717326|FG007|Participant Flow|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123364|NCT01717326|FG008|Participant Flow|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123365|NCT01717326|FG009|Participant Flow|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
11123366|NCT01717326|FG010|Participant Flow|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123367|NCT01717326|FG011|Participant Flow|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123368|NCT01717326|FG012|Participant Flow|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123369|NCT01717326|FG013|Participant Flow|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
11123370|NCT01717326|FG014|Participant Flow|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123371|NCT01717326|FG015|Participant Flow|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123372|NCT01717326|FG016|Participant Flow|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123373|NCT01717326|FG017|Participant Flow|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
11123374|NCT01717326|FG018|Participant Flow|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123375|NCT01717326|FG019|Participant Flow|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123376|NCT01717326|OG000|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123377|NCT01717326|OG001|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123378|NCT01717326|OG002|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123379|NCT01717326|OG003|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123380|NCT01717326|OG004|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123381|NCT01717326|OG005|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123382|NCT01717326|OG006|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123383|NCT01717326|OG007|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123384|NCT01717326|OG008|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123385|NCT01717326|OG009|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
11123386|NCT01717326|OG010|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123387|NCT01717326|OG011|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123388|NCT01717326|OG012|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123389|NCT01717326|OG013|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
11123390|NCT01717326|OG014|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123391|NCT01717326|OG015|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123392|NCT01717326|OG016|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123393|NCT01717326|OG017|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
11123394|NCT01717326|OG018|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123395|NCT01717326|OG019|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123396|NCT01717326|EG000|Reported Event|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123397|NCT01717326|EG001|Reported Event|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123398|NCT01717326|EG002|Reported Event|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123399|NCT01717326|EG003|Reported Event|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123400|NCT01717326|EG004|Reported Event|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123401|NCT01717326|EG005|Reported Event|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123402|NCT01717326|EG006|Reported Event|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123403|NCT01717326|EG007|Reported Event|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123404|NCT01717326|EG008|Reported Event|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123405|NCT01717326|EG009|Reported Event|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
11123406|NCT01717326|EG010|Reported Event|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123407|NCT01717326|EG011|Reported Event|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123408|NCT01717326|EG012|Reported Event|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123409|NCT01717326|EG013|Reported Event|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
11123410|NCT01717326|EG014|Reported Event|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123411|NCT01717326|EG015|Reported Event|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
11123412|NCT01717326|EG016|Reported Event|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123413|NCT01717326|EG017|Reported Event|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
11123414|NCT01717326|EG018|Reported Event|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123415|NCT01717326|EG019|Reported Event|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
11123416|NCT01717391|BG000|Baseline|FLT PET/CT|"FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.~Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow."
10846078|NCT00272961|FG001|Participant Flow|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
10846079|NCT00272961|FG002|Participant Flow|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
11123417|NCT01717391|FG000|Participant Flow|FLT PET/CT|"FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.~Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow."
11123418|NCT01717391|OG000|Outcome|Basline FLT PET/CT (All Subjects)|FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
11123419|NCT01717391|OG000|Outcome|FLT PET/CT|"FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.~Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow."
11123420|NCT01717391|OG000|Outcome|Bone-marrow Sparing Radiation Therapy (IMRT)|Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
11123421|NCT01717391|EG000|Reported Event|FLT PET/CT|"FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.~Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow."
11123422|NCT01717456|BG000|Baseline|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
11123423|NCT01717456|BG001|Baseline|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
11123424|NCT01717456|BG002|Baseline|Total|Total of all reporting groups
11123425|NCT01717456|FG000|Participant Flow|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
11123426|NCT01717456|FG001|Participant Flow|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
11123427|NCT01717456|OG000|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
11123428|NCT01717456|OG001|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
11123429|NCT01717456|OG000|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
11123430|NCT01717456|EG000|Reported Event|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [Mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
11123431|NCT01717456|EG001|Reported Event|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
11123432|NCT01717521|BG000|Baseline|Women Scheduled for Abdominal Hysterectomies.|Inclusion criteria : >18yrs, ASA 1-3, Scheduled for abdominal hysterectomies under general anesthesia
11123433|NCT01717521|FG000|Participant Flow|Women, Scheduled for Abdominal Hysterectomy|Women 18 years of age or older, of American Society of Anesthesiology Physical Status I-III scheduled for an abdominal hysterectomy under general anesthesia
11123434|NCT01717521|OG000|Outcome|Single Group|Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
11123435|NCT01717521|EG000|Reported Event|Single Group w Intervention|no adverse events were observed
11123436|NCT01717638|BG000|Baseline|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123437|NCT01717638|BG001|Baseline|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123438|NCT01717638|BG002|Baseline|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123439|NCT01717638|BG003|Baseline|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123440|NCT01717638|BG004|Baseline|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123441|NCT01717638|BG005|Baseline|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123442|NCT01717638|BG006|Baseline|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123443|NCT01717638|BG007|Baseline|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123444|NCT01717638|BG008|Baseline|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123445|NCT01717638|BG009|Baseline|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123446|NCT01717638|BG010|Baseline|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123447|NCT01717638|BG011|Baseline|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123448|NCT01717638|BG012|Baseline|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123449|NCT01717638|BG013|Baseline|Total|Total of all reporting groups
11123450|NCT01717638|FG000|Participant Flow|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123451|NCT01717638|FG001|Participant Flow|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123452|NCT01717638|FG002|Participant Flow|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123453|NCT01717638|FG003|Participant Flow|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123454|NCT01717638|FG004|Participant Flow|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123455|NCT01717638|FG005|Participant Flow|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123456|NCT01717638|FG006|Participant Flow|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123457|NCT01717638|FG007|Participant Flow|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123458|NCT01717638|FG008|Participant Flow|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123459|NCT01717638|FG009|Participant Flow|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123460|NCT01717638|FG010|Participant Flow|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123461|NCT01717638|FG011|Participant Flow|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123462|NCT01717638|FG012|Participant Flow|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123463|NCT01717638|OG000|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123464|NCT01717638|OG001|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123465|NCT01717638|OG002|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123466|NCT01717638|OG003|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123467|NCT01717638|OG004|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123468|NCT01717638|OG005|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123469|NCT01717638|OG006|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123470|NCT01717638|OG007|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123471|NCT01717638|OG008|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123472|NCT01717638|OG009|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123473|NCT01717638|OG000|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123474|NCT01717638|OG001|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123475|NCT01717638|OG002|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123476|NCT01717638|OG003|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123477|NCT01717638|OG003|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123478|NCT01717638|OG000|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123479|NCT01717638|OG000|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123480|NCT01717638|OG000|Outcome|B48 50 (After 1st Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123481|NCT01717638|OG001|Outcome|B48 50 (After 2nd Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123482|NCT01717638|EG000|Reported Event|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123483|NCT01717638|EG001|Reported Event|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123484|NCT01717638|EG002|Reported Event|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123485|NCT01717638|EG003|Reported Event|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123486|NCT01717638|EG004|Reported Event|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123487|NCT01717638|EG005|Reported Event|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123488|NCT01717638|EG006|Reported Event|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123489|NCT01717638|EG007|Reported Event|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123490|NCT01717638|EG008|Reported Event|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123491|NCT01717638|EG009|Reported Event|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123492|NCT01717638|EG010|Reported Event|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123493|NCT01717638|EG011|Reported Event|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
11123494|NCT01717638|EG012|Reported Event|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
11123495|NCT01717742|BG000|Baseline|Intervention (tPA & DNase)|Intrapleural tPA, 4 mg, followed by DNase (Roche), 5 mg
11123496|NCT01717742|BG001|Baseline|Placebo (tPA & Placebo)|Intrapleural tPA (Roche), 4 mg, followed by 5 mL of normal saline
11123497|NCT01717742|BG002|Baseline|Total|Total of all reporting groups
11123498|NCT01717742|FG000|Participant Flow|tPA (Tissue Plasminogen Activator) and Placebo|"tPA: Intrapleural administration of tPA 4 mg in 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days~Placebo: Intrapleural administration of normal saline 10 ml (≤10 kg) or 20 ml (>10 kg)"
11123499|NCT01717742|FG001|Participant Flow|tPA (Tissue Plasminogen Activator) and DNase|"tPA: Intrapleural administration of tPA 4 mg in 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days~DNase: Intrapleural administration of DNase 5 mg diluted to 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days"
11123500|NCT01717742|OG000|Outcome|Intervention|Intervention group received intrapleural tPA, 4 mg, followed by DNase (Roche), 5 mg
11123501|NCT01717742|OG001|Outcome|Control|Control group received intrapleural tPA (Roche), 4 mg, followed by 5 mL of normal saline
11123502|NCT01717742|EG000|Reported Event|Intervention|Intervention group received ) intrapleural tPA, 4 mg, followed by DNase (Roche), 5 mg
11123503|NCT01717742|EG001|Reported Event|Control|Control group received intrapleural tPA (Roche), 4 mg, followed by 5 mL of normal saline
11123504|NCT01717768|BG000|Baseline|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123505|NCT01717768|BG001|Baseline|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123506|NCT01717768|BG002|Baseline|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123507|NCT01717768|BG003|Baseline|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123508|NCT01717768|BG004|Baseline|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123509|NCT01717768|BG005|Baseline|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123510|NCT01717768|BG006|Baseline|Part 4 Cohort 1: 60 mg BID/ 60 mg TID|"Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123511|NCT01717768|BG007|Baseline|Part 4 Cohort 2: 90 mg BID/ 90 mg TID|"Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123512|NCT01717768|BG008|Baseline|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123513|NCT01717768|BG009|Baseline|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123514|NCT01717768|BG010|Baseline|Total|Total of all reporting groups
11123515|NCT01717768|FG000|Participant Flow|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11006201|NCT01084694|EG003|Reported Event|Caregivers for Patients Undergoing Allogeneic Transplants|Caregivers for patients undergoing allogeneic transplant. Only emotional distress was monitored for the caregivers
11006202|NCT01084707|BG000|Baseline|All Randomized Subjects|All subjects randomized into the trial, e.g., Full Analysis Set
11006203|NCT01084707|FG000|Participant Flow|Overall Study|All subjects randomized into the trial
11006204|NCT01084707|OG000|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
11006205|NCT01084707|OG001|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
11006206|NCT01084707|OG002|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
11006207|NCT01084707|OG003|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
11006208|NCT01084707|OG004|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
11006209|NCT01084707|EG000|Reported Event|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
11006210|NCT01084707|EG001|Reported Event|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
11006211|NCT01084707|EG002|Reported Event|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
11006212|NCT01084707|EG003|Reported Event|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
11006213|NCT01084707|EG004|Reported Event|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
11006214|NCT01084759|BG000|Baseline|Etoposide and Testosterone|Patients will receive an intramuscular gluteal injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).On the day of testosterone injection (i.e. day 1 of each cycle) patients will begin therapy with oral etoposide at a dose of 100 mg/day given in divided doses (one 50 mg etoposide capsule q 12 h) for 14 consecutive days.
11006215|NCT01084759|FG000|Participant Flow|Testosterone|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
11006216|NCT01084759|OG000|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
11006217|NCT01084759|EG000|Reported Event|Treatment Group|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
11006218|NCT01084772|BG000|Baseline|VISIONAIRE Instrumentation|"TKA with VISIONAIRE instrumentation~Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy."
11006219|NCT01084772|BG001|Baseline|Standard Instrumentation|"TKA with standard instrumentation~Total Knee Arthroplasty was performed using conventional instrumentation."
11006220|NCT01084772|BG002|Baseline|Total|Total of all reporting groups
11006221|NCT01084772|FG000|Participant Flow|VISIONAIRE Instrumentation|"TKA with VISIONAIRE instrumentation~Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy."
11006222|NCT01084772|FG001|Participant Flow|Standard Instrumentation|"TKA with standard instrumentation~Total Knee Arthroplasty was performed using conventional instrumentation."
11006223|NCT01084772|OG000|Outcome|VISIONAIRE Instrumentation|"TKA with VISIONAIRE instrumentation~Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy."
11006224|NCT01084772|OG001|Outcome|Standard Instrumentation|"TKA with standard instrumentation~Total Knee Arthroplasty was performed using conventional instrumentation."
11006225|NCT01084772|EG000|Reported Event|VISIONAIRE Instrumentation|"TKA with VISIONAIRE instrumentation~Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy."
11006226|NCT01084772|EG001|Reported Event|Standard Instrumentation|"TKA with standard instrumentation~Total Knee Arthroplasty was performed using conventional instrumentation."
11006227|NCT01085006|BG000|Baseline|Tranexamic Acid|
11006228|NCT01085006|BG001|Baseline|Normal Saline Infusion|
11006229|NCT01085006|BG002|Baseline|Total|Total of all reporting groups
11006230|NCT01085006|FG000|Participant Flow|Tranexamic Acid|
11006231|NCT01085006|FG001|Participant Flow|Normal Saline Infusion|
11006232|NCT01085006|OG000|Outcome|Tranexamic Acid|
11006233|NCT01085006|OG001|Outcome|Normal Saline Infusion|
11006234|NCT01085006|EG000|Reported Event|Tranexamic Acid|
11006235|NCT01085006|EG001|Reported Event|Normal Saline Infusion|
11006236|NCT01085045|BG000|Baseline|All Subjects|All Baseline Subjects
11006237|NCT01085045|FG000|Participant Flow|Overall Study|Sentinel patients were the first 4 patients enrolled to receive one week of treatment with either GFF MDI 72/9.6mcg, GFF MDI 36/9.6 mcg, GP MDI 36 mcg or FF MDI 9.6 mcg because this was the first time GFF MDI was administered to patients with COPD, the sentinel patients provided additional assurance of safety.9.6
11006238|NCT01085045|OG000|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
11006239|NCT01085045|OG001|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
11006240|NCT01085045|OG002|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
11006241|NCT01085045|OG003|Outcome|Spiriva 18 μg|Spiriva 18 μg
11006242|NCT01085045|OG004|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
11006243|NCT01085045|OG005|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
11006244|NCT01085045|OG006|Outcome|Foradil 12 μg|Foradil 12 μg
11006245|NCT01085045|OG003|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
11006246|NCT01085045|OG004|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
11006247|NCT01085045|OG005|Outcome|Foradil 12 μg|Foradil 12 μg
11006248|NCT01085045|EG000|Reported Event|GP/FF MDI 72/9.6 μg|GP/FF MDI 72/9.6 μg (PT003)
11006249|NCT01085045|EG001|Reported Event|GP/FF MDI 36/9.6 μg|GP/FF MDI 36/9.6 μg (PT003)
11006250|NCT01085045|EG002|Reported Event|GP MDI 36 μg|GP MDI 36 μg (PT001)
11006251|NCT01085045|EG003|Reported Event|Spiriva|Handihaler 18 μg
11006252|NCT01085045|EG004|Reported Event|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
11006253|NCT01085045|EG005|Reported Event|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
11006254|NCT01085045|EG006|Reported Event|Placebo|Placebo MDI
11006255|NCT01085045|EG007|Reported Event|Foradil Aerolizer|Foradil Aerolizer 12 μg
11006256|NCT01085136|BG000|Baseline|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
11006257|NCT01085136|FG000|Participant Flow|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
11006258|NCT01085136|FG001|Participant Flow|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
11006259|NCT01085136|FG002|Participant Flow|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
11006260|NCT01085136|OG000|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
11006261|NCT01085136|OG001|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
11006262|NCT01085136|OG000|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
11006263|NCT01085136|OG001|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
11006264|NCT01085136|OG002|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
11006265|NCT01085136|EG000|Reported Event|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
11006266|NCT01085136|EG001|Reported Event|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
11006267|NCT01085136|EG002|Reported Event|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
11006268|NCT01085201|BG000|Baseline|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006269|NCT01085201|BG001|Baseline|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006270|NCT01085201|BG002|Baseline|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006271|NCT01085201|BG003|Baseline|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006272|NCT01085201|BG004|Baseline|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006273|NCT01085201|BG005|Baseline|Total|Total of all reporting groups
11006274|NCT01085201|FG000|Participant Flow|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006275|NCT01085201|FG001|Participant Flow|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006276|NCT01085201|FG002|Participant Flow|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006277|NCT01085201|FG003|Participant Flow|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006278|NCT01085201|FG004|Participant Flow|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006279|NCT01085201|OG000|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006280|NCT01085201|OG001|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006281|NCT01085201|OG002|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006282|NCT01085201|OG003|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006283|NCT01085201|OG004|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006284|NCT01085201|OG000|Outcome|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006285|NCT01085201|OG001|Outcome|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006286|NCT01085201|OG002|Outcome|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006287|NCT01085201|OG003|Outcome|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006288|NCT01085201|OG004|Outcome|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006289|NCT01085201|EG000|Reported Event|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006290|NCT01085201|EG001|Reported Event|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006291|NCT01085201|EG002|Reported Event|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006292|NCT01085201|EG003|Reported Event|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006293|NCT01085201|EG004|Reported Event|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
11006294|NCT01085214|BG000|Baseline|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
11006295|NCT01085214|FG000|Participant Flow|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
11006296|NCT01085214|OG000|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
11006297|NCT01085214|EG000|Reported Event|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
11006298|NCT01085318|BG000|Baseline|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
11006299|NCT01085318|BG001|Baseline|Arm 2 Healthy Control|Healthy Control
11006300|NCT01085318|BG002|Baseline|Total|Total of all reporting groups
11006301|NCT01085318|FG000|Participant Flow|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
11006302|NCT01085318|FG001|Participant Flow|Arm 2 Healthy Control|Healthy Control
11006303|NCT01085318|OG000|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
11006304|NCT01085318|OG001|Outcome|Arm 2 Healthy Control|Healthy Control
11006305|NCT01085318|EG000|Reported Event|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
11006306|NCT01085318|EG001|Reported Event|Arm 2 Healthy Control|Healthy Control
11006307|NCT01085331|BG000|Baseline|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11123516|NCT01717768|FG001|Participant Flow|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123517|NCT01717768|FG002|Participant Flow|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123518|NCT01717768|FG003|Participant Flow|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123519|NCT01717768|FG004|Participant Flow|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
11123520|NCT01717768|FG005|Participant Flow|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
11123521|NCT01717768|FG006|Participant Flow|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123522|NCT01717768|FG007|Participant Flow|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days~TSX-002 are capsules with testosterone as the active ingredient."
11123523|NCT01717768|FG008|Participant Flow|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123524|NCT01717768|FG009|Participant Flow|Part 4 Cohort 2: 90 mg TID|Oral TSX-002 90 mg TID for 15 days
11123525|NCT01717768|FG010|Participant Flow|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123526|NCT01717768|FG011|Participant Flow|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123527|NCT01717768|OG000|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123528|NCT01717768|OG001|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123529|NCT01717768|OG002|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123530|NCT01717768|OG003|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123531|NCT01717768|OG004|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
11123532|NCT01717768|OG005|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123533|NCT01717768|OG006|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123534|NCT01717768|OG007|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123535|NCT01717768|OG008|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123536|NCT01717768|OG000|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
11123537|NCT01717768|OG001|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
11123538|NCT01717768|OG002|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
11123539|NCT01717768|EG000|Reported Event|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123540|NCT01717768|EG001|Reported Event|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123541|NCT01717768|EG002|Reported Event|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123542|NCT01717768|EG003|Reported Event|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123543|NCT01717768|EG004|Reported Event|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123544|NCT01717768|EG005|Reported Event|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123545|NCT01717768|EG006|Reported Event|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123546|NCT01717768|EG007|Reported Event|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123547|NCT01717768|EG008|Reported Event|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123548|NCT01717768|EG009|Reported Event|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123549|NCT01717768|EG010|Reported Event|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123550|NCT01717768|EG011|Reported Event|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
11123551|NCT01717859|BG000|Baseline|Tocilizumab|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123552|NCT01717859|FG000|Participant Flow|Tocilizumab|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123553|NCT01717859|OG000|Outcome|Mean Change of Total Power Doppler Synovitis Score 3 Month|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123554|NCT01717859|OG000|Outcome|Mean Change of Total Power Doppler Synovitis Score 6 Month|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123555|NCT01717859|OG000|Outcome|Mean Change Total B-mode Synovial Hypertrophy Score 3 Month|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123556|NCT01717859|OG000|Outcome|Mean Change Total B-mode Synovial Hypertrophy Score 6 Month|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123557|NCT01717859|OG000|Outcome|Mean Change in DAS28/ESR 3 Month|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123558|NCT01717859|OG000|Outcome|Mean Change in DAS28/ESR 6 Month|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123559|NCT01717859|OG000|Outcome|Mean Change in CDAI 3 Month|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123560|NCT01717859|OG000|Outcome|Mean Change in CDAI 6 Month|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123561|NCT01717859|EG000|Reported Event|Tocilizumab|"All subjects will receive tocilizumab.~Tocilizumab: All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg."
11123562|NCT01717872|BG000|Baseline|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
11123563|NCT01717872|BG001|Baseline|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
11123564|NCT01717872|BG002|Baseline|Total|Total of all reporting groups
11123565|NCT01717872|FG000|Participant Flow|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
11123566|NCT01717872|FG001|Participant Flow|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
11123567|NCT01717872|OG000|Outcome|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
11123568|NCT01717872|OG001|Outcome|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
11123569|NCT01717872|OG000|Outcome|Miller Blade Lifting the Epiglottis|Miller blade was inserted under the epiglottis to lift it to view the glottic opening
11123570|NCT01717872|OG001|Outcome|Miller Blade Lifting the Tongue|Miller blade was inserted under the tongue (above the epiglottis) to view the glottic opening
11123571|NCT01717872|OG000|Outcome|MAC Blade Lifting the Tongue|The MAC blade was inserted under the tongue and lifted to view the percent glottic opening
11123572|NCT01717872|OG001|Outcome|MAC Blade Lifting the Epiglottis|The MAC blade was inserted under the epiglottis and lift to view the percent glottic opening
11123573|NCT01717872|EG000|Reported Event|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
11123574|NCT01717872|EG001|Reported Event|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
11123575|NCT01717898|BG000|Baseline|Abiraterone/Prednisone + BEZ235|"In Phase I, a dose escalation of BEZ235 will be performed using a standard 3 + 3 design to determine the maximum tolerated dose (MTD) of BEZ235 given in combination with continuous fixed doses of Abiraterone Acetate and prednisone. This BEZ235 dose will be used in the phase II portion of the study.~BEZ235: BEZ235 - 200 mg, 300 mg, or 400 mg; po, BID. BEZ235 will be supplied in 200 mg, 300 mg, and 400 mg sachets packaged in boxes.~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po. Abiraterone Acetate is supplied in 250 mg white tablets, four tablets are to be taken with a full glass of water on an empty stomach once daily."
11123576|NCT01717898|FG000|Participant Flow|Phase I: BEZ235 200 mg|"Dose level 1:~200 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily~Abiraterone acetate: 1000 mg, PO daily"
11123577|NCT01717898|FG001|Participant Flow|Phase I: BEZ235 300 mg|"Dose level 2:~300 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily.~Abiraterone acetate: 1000 mg, PO daily"
11123578|NCT01717898|FG002|Participant Flow|Phase I: BEZ235 400 mg|"Dose level 3:~400 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po."
11123579|NCT01717898|FG003|Participant Flow|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
11123580|NCT01717898|OG000|Outcome|Phase I: BEZ235 200 mg|"Dose level 1:~200 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
11123581|NCT01717898|OG001|Outcome|Phase I: BEZ235 300 mg|"Dose level 2:~300 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
11123582|NCT01717898|OG002|Outcome|Phase I: BEZ235 400 mg|"Dose level 3:~400 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po."
11123583|NCT01717898|OG003|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
11123584|NCT01717898|OG000|Outcome|BEZ235|Trough concentration of BEZ235 when used in combination with Abiraterone plus Prednisone.
11123585|NCT01717898|OG001|Outcome|Abiraterone Acetate|Trough concentration of Abiraterone acetate when used in combination with BEZ235 plus Prednisone.
11123586|NCT01717898|OG000|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
11006308|NCT01085331|BG001|Baseline|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006309|NCT01085331|BG002|Baseline|Total|Total of all reporting groups
11006310|NCT01085331|FG000|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 milligrams per day (mg/day) once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2.) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006311|NCT01085331|FG001|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; Irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006312|NCT01085331|OG000|Outcome|Pimasertib+FOLFIRI (Overall)|Pimasertib was administered orally once daily 45 mg/day and 60 mg/day on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006313|NCT01085331|OG000|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006314|NCT01085331|OG001|Outcome|Part 2 or Phase 2 Randomized Part: Placebo +FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006315|NCT01085331|OG000|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006316|NCT01085331|OG001|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006317|NCT01085331|OG001|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006318|NCT01085331|EG000|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006319|NCT01085331|EG001|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
11006320|NCT01085344|BG000|Baseline|Factor VIII|"escalating dose Factor VIII~Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS): escalating dose prophylaxis~Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS): escalating dose"
11006321|NCT01085344|FG000|Participant Flow|Factor VIII|"escalating dose Factor VIII~Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS): escalating dose prophylaxis~Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS): escalating dose"
11006322|NCT01085344|OG000|Outcome|Factor VIII|"escalating dose Factor VIII~Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS): escalating dose prophylaxis~Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS): escalating dose"
11006323|NCT01085344|EG000|Reported Event|Factor VIII|"escalating dose Factor VIII~Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS): escalating dose prophylaxis~Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS): escalating dose"
11006324|NCT01085357|BG000|Baseline|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
11006325|NCT01085357|BG001|Baseline|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
11006326|NCT01085357|BG002|Baseline|Total|Total of all reporting groups
11006327|NCT01085357|FG000|Participant Flow|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
11006328|NCT01085357|FG001|Participant Flow|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
11006329|NCT01085357|OG000|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
11006330|NCT01085357|OG001|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
11006331|NCT01085357|EG000|Reported Event|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
11006332|NCT01085357|EG001|Reported Event|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
11006333|NCT01085500|BG000|Baseline|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
11006334|NCT01085500|BG001|Baseline|Current Practice|General surgery residents will undergo training according to current practice.
11006335|NCT01085500|BG002|Baseline|Total|Total of all reporting groups
11006336|NCT01085500|FG000|Participant Flow|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
11006337|NCT01085500|FG001|Participant Flow|Current Practice|General surgery residents will undergo training according to current practice.
11006338|NCT01085500|OG000|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
11006339|NCT01085500|OG001|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
11006340|NCT01085500|EG000|Reported Event|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
11006341|NCT01085500|EG001|Reported Event|Current Practice|General surgery residents will undergo training according to current practice.
11006342|NCT01085513|BG000|Baseline|Patients|"Patients previously indicated for manometry~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
11006343|NCT01085513|BG001|Baseline|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
11006344|NCT01085513|BG002|Baseline|Total|Total of all reporting groups
11006345|NCT01085513|FG000|Participant Flow|Patients|Patients previously indicated for manometry
11006346|NCT01085513|FG001|Participant Flow|Healthy Volunteers|Healthy volunteers
11006347|NCT01085513|OG000|Outcome|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
11006348|NCT01085513|OG001|Outcome|Patients|"Patients previously indicated for manometry~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
11006349|NCT01085513|EG000|Reported Event|Patients|"Patients previously indicated for manometry~Two Moderate adverse events not related to studies procedure were reported within this study: abdominal pain and nausea.~In one case (i.e., abdominal pain) emergency visit occurred and the adverse events was resolved within four days."
11006350|NCT01085513|EG001|Reported Event|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
11006351|NCT01085539|BG000|Baseline|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
11006352|NCT01085539|FG000|Participant Flow|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
11006353|NCT01085539|OG000|Outcome|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
11006354|NCT01085539|EG000|Reported Event|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
11006355|NCT01085591|BG000|Baseline|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
11006356|NCT01085591|BG001|Baseline|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
11006357|NCT01085591|BG002|Baseline|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
11006358|NCT01085591|BG003|Baseline|Total|Total of all reporting groups
11006359|NCT01085591|FG000|Participant Flow|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
11006360|NCT01085591|FG001|Participant Flow|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
11006361|NCT01085591|FG002|Participant Flow|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
11006362|NCT01085591|OG000|Outcome|CB-183,315, 125mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
11006363|NCT01085591|OG001|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
11006364|NCT01085591|OG002|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
11006365|NCT01085591|OG000|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
11006366|NCT01085591|EG000|Reported Event|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
11006367|NCT01085591|EG001|Reported Event|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
11006368|NCT01085591|EG002|Reported Event|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
11006369|NCT01085630|BG000|Baseline|Arm A (Observation)|Patients undergo observation until disease progression.
11006370|NCT01085630|BG001|Baseline|Arm B (Pemetrexed)|Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
11006371|NCT01085630|BG002|Baseline|Total|Total of all reporting groups
11006372|NCT01085630|FG000|Participant Flow|Arm A (Observation)|Patients undergo observation until disease progression.
11006373|NCT01085630|FG001|Participant Flow|Arm B (Pemetrexed)|Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
11006374|NCT01085630|OG000|Outcome|Arm A (Observation)|Patients undergo observation until disease progression.
11006375|NCT01085630|OG001|Outcome|Arm B (Pemetrexed)|Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
11006376|NCT01085630|OG000|Outcome|Arm B (Pemetrexed)|Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
11006377|NCT01085630|EG000|Reported Event|Arm B (Pemetrexed)|Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
11006378|NCT01085682|BG000|Baseline|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
11006379|NCT01085682|BG001|Baseline|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
11006380|NCT01085682|BG002|Baseline|Total|Total of all reporting groups
11006381|NCT01085682|FG000|Participant Flow|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
11006382|NCT01085682|FG001|Participant Flow|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
11006383|NCT01085682|OG000|Outcome|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
11006384|NCT01085682|OG001|Outcome|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
11006385|NCT01085682|EG000|Reported Event|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
11006386|NCT01085682|EG001|Reported Event|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
11006387|NCT01085734|BG000|Baseline|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
11006388|NCT01085734|BG001|Baseline|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
11006389|NCT01085734|BG002|Baseline|Total|Total of all reporting groups
11006390|NCT01085734|FG000|Participant Flow|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros
11006391|NCT01085734|FG001|Participant Flow|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
11006392|NCT01085734|OG000|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
11123587|NCT01717898|EG000|Reported Event|Phase I: Abiraterone/Prednisone + BEZ235 200 mg|Study was terminated during Phase I, Dose level 1 due to toxicity.
11123588|NCT01717976|BG000|Baseline|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
11123589|NCT01717976|BG001|Baseline|Control|usual care
11123590|NCT01717976|BG002|Baseline|Total|Total of all reporting groups
11123591|NCT01717976|FG000|Participant Flow|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
11123592|NCT01717976|FG001|Participant Flow|Control|usual care
11123593|NCT01717976|OG000|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
11123594|NCT01717976|OG001|Outcome|Control|usual care
11123595|NCT01717976|EG000|Reported Event|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
11123596|NCT01717976|EG001|Reported Event|Control|usual care
11123597|NCT01717989|BG000|Baseline|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
11123598|NCT01717989|FG000|Participant Flow|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
11123599|NCT01717989|OG000|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
11123600|NCT01717989|OG000|Outcome|Q4 2010|Fourth quarter (Q4) 2010
11123601|NCT01717989|OG001|Outcome|Q1 2011|First quarter (Q1), 2011
11123602|NCT01717989|OG002|Outcome|Q2 2011|Second quarter (Q2), 2011
11123603|NCT01717989|OG003|Outcome|Q3 2011|Third quarter (Q3) 2011
11123604|NCT01717989|OG004|Outcome|Q4 2011|Fourth quarter, 2011
11123605|NCT01717989|OG000|Outcome|Q4 2010|Fourth quarter, 2010
11123606|NCT01717989|OG001|Outcome|Q1 2011|First quarter 2011
11123607|NCT01717989|OG002|Outcome|Q2 2011|Second quarter, 2011
11123608|NCT01717989|OG003|Outcome|Q3 2011|Third quarter, 2011
11123609|NCT01717989|OG000|Outcome|December 2010|
11123610|NCT01717989|OG001|Outcome|March 2011|
11123611|NCT01717989|OG002|Outcome|June 2011|
11123612|NCT01717989|OG003|Outcome|September 2011|
11123613|NCT01717989|OG004|Outcome|December 2011|
11123614|NCT01717989|OG000|Outcome|2010|From June through December 2010
11123615|NCT01717989|EG000|Reported Event|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
11123616|NCT01718028|BG000|Baseline|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
11123617|NCT01718028|BG001|Baseline|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
11123618|NCT01718028|BG002|Baseline|Total|Total of all reporting groups
11123619|NCT01718028|FG000|Participant Flow|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
11123620|NCT01718028|FG001|Participant Flow|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
11123621|NCT01718028|OG000|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
11123622|NCT01718028|OG001|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
11123623|NCT01718028|EG000|Reported Event|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
11123624|NCT01718028|EG001|Reported Event|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
11123625|NCT01718353|BG000|Baseline|Docetaxel + Prednisone (Treatment A)|Docetaxel 75 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4 switched to Cabazitaxel 25mg/m^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant's refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant's refusal of further study treatment.
11123626|NCT01718353|BG001|Baseline|Cabazitaxel + Prednisone (Treatment B)|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4 switched to Docetaxel 75mg/m^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant's refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant's refusal of further study treatment.
11123627|NCT01718353|BG002|Baseline|Total|Total of all reporting groups
11123628|NCT01718353|FG000|Participant Flow|Docetaxel + Prednisone (Treatment A)|Docetaxel 75 mg/m^2 intravenous (IV) infusion on Day 1 of Cycle 1 and every 3 weeks (q3w) thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% prostate-specific antigen (PSA) reduction from baseline at the end of Cycle 4 switched to Cabazitaxel 25mg/m^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), death, unacceptable toxicity or participant's refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant's refusal of further study treatment.
11123629|NCT01718353|FG001|Participant Flow|Cabazitaxel + Prednisone (Treatment B)|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4 switched to Docetaxel 75mg/m^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant's refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant's refusal of further study treatment.
11123630|NCT01718353|OG000|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant's refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant's refusal of further study treatment.
11123631|NCT01718353|OG000|Outcome|Overall Population (AR-target Agent Treated)|Participants having prior treatment experience with a high potency AR targeted agent (AR signaling inhibitor or CYP 17) before this study.
11123632|NCT01718353|OG001|Outcome|Overall Population (Non AR-target Agent Treated)|Participants not having prior treatment experience with a high potency AR targeted agent (AR signaling inhibitor or CYP 17 inhibitor) before this study.
11123633|NCT01718353|EG000|Reported Event|Docetaxel + Prednisone (Treatment A) - Throughout|Docetaxel 75 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment throughout until DP, death, unacceptable toxicity or participant's refusal of further study treatment.
11123634|NCT01718353|EG001|Reported Event|Cabazitaxel + Prednisone (Treatment B) - Throughout|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment throughout until DP, death, unacceptable toxicity or participant's refusal of further study treatment.
11123635|NCT01718353|EG002|Reported Event|Switched Population (Treatment A to B or Treatment B to A)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4 switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant's refusal of further study treatment.
11123636|NCT01718483|BG000|Baseline|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
11123637|NCT01718483|BG001|Baseline|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
11123638|NCT01718483|BG002|Baseline|Total|Total of all reporting groups
11123639|NCT01718483|FG000|Participant Flow|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily, for up to 12 weeks.
11123640|NCT01718483|FG001|Participant Flow|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 milligram (mg) administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
11123641|NCT01718483|OG000|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
11123642|NCT01718483|OG001|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
11123643|NCT01718483|EG000|Reported Event|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
11123644|NCT01718483|EG001|Reported Event|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
11123645|NCT01718509|BG000|Baseline|PLACEBO|
11123646|NCT01718509|BG001|Baseline|SPD489|
11123647|NCT01718509|BG002|Baseline|Total|Total of all reporting groups
11123648|NCT01718509|FG000|Participant Flow|PLACEBO|Administered once-daily, orally, for up to 12 weeks
11123649|NCT01718509|FG001|Participant Flow|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
10846080|NCT00272961|FG003|Participant Flow|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
11123650|NCT01718509|OG000|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
11123651|NCT01718509|OG001|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
11123652|NCT01718509|EG000|Reported Event|PLACEBO|Administered once-daily, orally, for up to 12 weeks
11123653|NCT01718509|EG001|Reported Event|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
11123654|NCT01718522|BG000|Baseline|Intervention Group|Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).
11123655|NCT01718522|FG000|Participant Flow|Intervention Group|Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)
11123656|NCT01718522|OG000|Outcome|Intervention Group|Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).
11123657|NCT01718522|OG000|Outcome|Intervention Group|Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)
11123658|NCT01718522|OG000|Outcome|Intervention Group|Patients treated with Sensor-augmented pump therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).
11123659|NCT01718522|OG000|Outcome|Intervention Group|"Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).~sensor augmented pump (SaP)"
11123660|NCT01718522|EG000|Reported Event|Intervention Group|Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).
11123661|NCT01718535|BG000|Baseline|*1/*1 CYP2C19 Genotype|
11123662|NCT01718535|BG001|Baseline|*1/*2 CYP2C19 Genotype|
11123663|NCT01718535|BG002|Baseline|*2/*2 CYP2C19 Genotype|
11123664|NCT01718535|BG003|Baseline|*1/*3 CYP2C19 Genotype|
11123665|NCT01718535|BG004|Baseline|*3/*3 CYP2C19 Genotype|
11123666|NCT01718535|BG005|Baseline|*1/*17 CYP2C19 Genotype|
11123667|NCT01718535|BG006|Baseline|*17/*17 CYP2C19 Genotype|
11123668|NCT01718535|BG007|Baseline|*2/*3 CYP2C19 Genotype|
11123669|NCT01718535|BG008|Baseline|*2/*17 CYP2C19 Genotype|
11123670|NCT01718535|BG009|Baseline|*3/*17 CYP2C19 Genotype|
11123671|NCT01718535|BG010|Baseline|Total|Total of all reporting groups
11123672|NCT01718535|FG000|Participant Flow|*1/*1 CYP2C19 Genotype|
11123673|NCT01718535|FG001|Participant Flow|*1/*2 CYP2C19 Genotype|
11123674|NCT01718535|FG002|Participant Flow|*2/*2 CYP2C19 Genotype|
11123675|NCT01718535|FG003|Participant Flow|*1/*3 CYP2C19 Genotype|
11123676|NCT01718535|FG004|Participant Flow|*3/*3 CYP2C19 Genotype|
11123677|NCT01718535|FG005|Participant Flow|*1/*17 CYP2C19 Genotype|
11123678|NCT01718535|FG006|Participant Flow|*17/*17 CYP2C19 Genotype|
11123679|NCT01718535|FG007|Participant Flow|*2/*3 CYP2C19 Genotype|
11123680|NCT01718535|FG008|Participant Flow|*2/*17 CYP2C19 Genotype|
11123681|NCT01718535|FG009|Participant Flow|*3/*17 CYP2C19 Genotype|
11123682|NCT01718535|OG000|Outcome|*1/*1 CYP2C19 Genotype|
11123683|NCT01718535|OG001|Outcome|*1/*2 CYP2C19 Genotype|
11123684|NCT01718535|OG002|Outcome|*2/*2 CYP2C19 Genotype|
11123685|NCT01718535|OG003|Outcome|*1/*3 CYP2C19 Genotype|
11123686|NCT01718535|OG004|Outcome|*3/*3 CYP2C19 Genotype|
11123687|NCT01718535|OG005|Outcome|*1/*17 CYP2C19 Genotype|
11123688|NCT01718535|OG006|Outcome|*17/*17 CYP2C19 Genotype|
11123689|NCT01718535|OG007|Outcome|*2/*3 CYP2C19 Genotype|
11123690|NCT01718535|OG008|Outcome|*2/*17 CYP2C19 Genotype|
11123691|NCT01718535|OG009|Outcome|*3/*17 CYP2C19 Genotype|
11123692|NCT01718535|EG000|Reported Event|*1/*1 CYP2C19 Genotype|
11123693|NCT01718535|EG001|Reported Event|*1/*2 CYP2C19 Genotype|
11123694|NCT01718535|EG002|Reported Event|*2/*2 CYP2C19 Genotype|
11123695|NCT01718535|EG003|Reported Event|*1/*3 CYP2C19 Genotype|
11123696|NCT01718535|EG004|Reported Event|*3/*3 CYP2C19 Genotype|
11123697|NCT01718535|EG005|Reported Event|*1/*17 CYP2C19 Genotype|
11123698|NCT01718535|EG006|Reported Event|*17/*17 CYP2C19 Genotype|
11123699|NCT01718535|EG007|Reported Event|*2/*3 CYP2C19 Genotype|
11123700|NCT01718535|EG008|Reported Event|*2/*17 CYP2C19 Genotype|
11123701|NCT01718535|EG009|Reported Event|*3/*17 CYP2C19 Genotype|
11123702|NCT01718691|BG000|Baseline|Low-grade B-cell Non-Hodgkin's Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
11123703|NCT01718691|BG001|Baseline|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
11123704|NCT01718691|BG002|Baseline|Total|Total of all reporting groups
11123705|NCT01718691|FG000|Participant Flow|Low-grade B-cell Non-Hodgkin's Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
11123706|NCT01718691|FG001|Participant Flow|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
11123707|NCT01718691|OG000|Outcome|Low-grade B-cell Non-Hodgkin's Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
11123708|NCT01718691|OG001|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
11123709|NCT01718691|OG002|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
11123710|NCT01718691|OG000|Outcome|Low-grade B-cell Non-Hodgkin's Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
11123711|NCT01718691|OG001|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
11123712|NCT01718691|OG002|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
11123713|NCT01718691|OG000|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
11123714|NCT01718691|OG000|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
11123715|NCT01718691|EG000|Reported Event|SyB L-0501＋Rituximab|"Drug: SyB L-0501~A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.~Drug: rituximab~A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0."
11123716|NCT01719003|BG000|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
11123717|NCT01719003|BG001|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
11123718|NCT01719003|BG002|Baseline|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
11123719|NCT01719003|BG003|Baseline|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
11123720|NCT01719003|BG004|Baseline|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
11123721|NCT01719003|BG005|Baseline|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
11123722|NCT01719003|BG006|Baseline|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
11123723|NCT01719003|BG007|Baseline|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
11123724|NCT01719003|BG008|Baseline|Total|Total of all reporting groups
11123725|NCT01719003|FG000|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
11123726|NCT01719003|FG001|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
11123727|NCT01719003|FG002|Participant Flow|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
11006393|NCT01085734|OG001|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
11006394|NCT01085734|OG000|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
11006395|NCT01085734|EG000|Reported Event|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
11006396|NCT01085734|EG001|Reported Event|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
11006397|NCT01085760|BG000|Baseline|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
11006398|NCT01085760|BG001|Baseline|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
11006399|NCT01085760|BG002|Baseline|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
11006400|NCT01085760|BG003|Baseline|High Dose Metronidazole|metronidazole 500 mg 3 times a day
11006401|NCT01085760|BG004|Baseline|Total|Total of all reporting groups
11006402|NCT01085760|FG000|Participant Flow|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
11006403|NCT01085760|FG001|Participant Flow|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
11006404|NCT01085760|FG002|Participant Flow|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
11006405|NCT01085760|FG003|Participant Flow|High Dose Metronidazole|metronidazole 500 mg 3 times a day
11006406|NCT01085760|OG000|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
11006407|NCT01085760|OG001|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
11006408|NCT01085760|OG002|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
11006409|NCT01085760|OG003|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
11006410|NCT01085760|EG000|Reported Event|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
11006411|NCT01085760|EG001|Reported Event|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
11006412|NCT01085760|EG002|Reported Event|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
11006413|NCT01085760|EG003|Reported Event|High Dose Metronidazole|metronidazole 500 mg 3 times a day
11006414|NCT01085786|BG000|Baseline|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
11006415|NCT01085786|BG001|Baseline|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
11006416|NCT01085786|BG002|Baseline|Total|Total of all reporting groups
11006417|NCT01085786|FG000|Participant Flow|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
11006418|NCT01085786|FG001|Participant Flow|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
11006419|NCT01085786|OG000|Outcome|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
11006420|NCT01085786|OG001|Outcome|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
11006421|NCT01085786|EG000|Reported Event|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
11006422|NCT01085786|EG001|Reported Event|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
11006423|NCT01085812|BG000|Baseline|Open Label Levomilnacipran ER|40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing.
11006424|NCT01085812|FG000|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing.
11006425|NCT01085812|FG001|Participant Flow|Levomilnacipran ER|40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.
11006426|NCT01085812|OG000|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing.
11006427|NCT01085812|OG001|Outcome|Levomilnacipran ER|40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing.
11006428|NCT01085812|EG000|Reported Event|Open Label Levomilnacipran ER|40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing.
11006429|NCT01085812|EG001|Reported Event|Placebo - Double Blind Treatment|Matching placebo capsules, oral administration, once daily dosing.
11006430|NCT01085812|EG002|Reported Event|Levomilnacipran ER - Double Blind Treatment|40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing.
11006431|NCT01085825|BG000|Baseline|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
11006432|NCT01085825|BG001|Baseline|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
11006433|NCT01085825|BG002|Baseline|Total|Total of all reporting groups
11123728|NCT01719003|FG003|Participant Flow|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
11123729|NCT01719003|FG004|Participant Flow|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
11123730|NCT01719003|FG005|Participant Flow|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
11123731|NCT01719003|FG006|Participant Flow|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
11123732|NCT01719003|FG007|Participant Flow|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
11123733|NCT01719003|FG008|Participant Flow|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
11123734|NCT01719003|OG000|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
11123735|NCT01719003|OG001|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
11123736|NCT01719003|OG002|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
11123737|NCT01719003|OG003|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
11123738|NCT01719003|OG004|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
11123739|NCT01719003|OG005|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
11123740|NCT01719003|OG006|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
11123741|NCT01719003|OG007|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
11123742|NCT01719003|EG000|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
11123743|NCT01719003|EG001|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
11123744|NCT01719003|EG002|Reported Event|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
11123745|NCT01719003|EG003|Reported Event|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
11123746|NCT01719003|EG004|Reported Event|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
11123747|NCT01719003|EG005|Reported Event|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
11123748|NCT01719003|EG006|Reported Event|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
11123749|NCT01719003|EG007|Reported Event|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
11123750|NCT01719003|EG008|Reported Event|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
11123751|NCT01719172|BG000|Baseline|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
11123752|NCT01719172|FG000|Participant Flow|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
11123753|NCT01719172|OG000|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
11123754|NCT01719172|EG000|Reported Event|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
11123755|NCT01719224|BG000|Baseline|Total Study Population (N=55)|Fifty-five patients were enrolled within 48 hours after delivery from two newborn family units at MGH hospital.
11123756|NCT01719224|FG000|Participant Flow|Experimental: Elevated Position, Then Non-Elevated Position|In the beginning of the study night, participants were placed in a sleeping position at 45 degrees upper body elevation. After 3.5h, a study member changed the patients bed to a non-elevated position. We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen during the study night.
11123757|NCT01719224|FG001|Participant Flow|Experimental: Non-Elevated Position, Then Elevated Position|In the beginning of the study night, participants were placed in a non-elevated sleeping position. After 3.5h, a study member changed the patients bed to a 45 degrees upper body position. We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen during the study night.
11123758|NCT01719224|OG000|Outcome|Elevated Upper Body Position|"We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.~elevated body position: 45 degrees elevated upper body position"
11123759|NCT01719224|OG001|Outcome|Non-elevated Upper Body Position|"We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.~Supine body position: non-elevated upper body position"
11123760|NCT01719224|OG000|Outcome|Sitting Position|Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a sitting position
11123761|NCT01719224|OG001|Outcome|Non-elevated Position|Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a non-elevated (supine) position.
11123762|NCT01719224|OG002|Outcome|45 Degree Elevation|Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a non-elevated (supine) position.
11123763|NCT01719224|EG000|Reported Event|Elevated Body Position|"We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.~elevated body position: 45 degrees elevated upper body position"
11123764|NCT01719224|EG001|Reported Event|Supine Body Position|"We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.~supine body position: non-elevated upper body position"
11123765|NCT01719367|BG000|Baseline|All Participants|all participants
11123766|NCT01719367|FG000|Participant Flow|Atenolol: Ancestral Alleles|"Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.~participants have Ancestral Alleles"
11123767|NCT01719367|FG001|Participant Flow|Atenolol: Variant Carriers|"Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.~participants have Variant Carriers"
11123768|NCT01719367|OG000|Outcome|Atenolol: Ancestral Alleles|"Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.~These patients have Ancestral Alleles"
11123769|NCT01719367|OG001|Outcome|Atenolol: Variant Carriers|"Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.~These patients have Variant Carriers"
11123770|NCT01719367|EG000|Reported Event|Atenolol: Ancestral Alleles|"Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.~These patients have Ancestral Alleles"
11123771|NCT01719367|EG001|Reported Event|Atenolol: Variant Carriers|"Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.~These patients have Variant Carriers"
11123772|NCT01719380|BG000|Baseline|Phase 1b: LGX818 100 mg + Cetuximab|Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123773|NCT01719380|BG001|Baseline|Phase 1b: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123774|NCT01719380|BG002|Baseline|Phase 1b: LGX818 400 mg + Cetuximab|Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123775|NCT01719380|BG003|Baseline|Phase 1b: LGX818 450 mg + Cetuximab|Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123776|NCT01719380|BG004|Baseline|Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab|Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123777|NCT01719380|BG005|Baseline|Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab|Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123778|NCT01719380|BG006|Baseline|Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123779|NCT01719380|BG007|Baseline|Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab|Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123780|NCT01719380|BG008|Baseline|Phase 2: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123781|NCT01719380|BG009|Baseline|Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123782|NCT01719380|BG010|Baseline|Total|Total of all reporting groups
11123783|NCT01719380|FG000|Participant Flow|Phase 1b: LGX818 100 mg + Cetuximab|Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123784|NCT01719380|FG001|Participant Flow|Phase 1b: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123785|NCT01719380|FG002|Participant Flow|Phase 1b: LGX818 400 mg + Cetuximab|Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123786|NCT01719380|FG003|Participant Flow|Phase 1b: LGX818 450 mg + Cetuximab|Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123787|NCT01719380|FG004|Participant Flow|Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab|Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123788|NCT01719380|FG005|Participant Flow|Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab|Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123789|NCT01719380|FG006|Participant Flow|Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123790|NCT01719380|FG007|Participant Flow|Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab|Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123791|NCT01719380|FG008|Participant Flow|Phase 2: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123792|NCT01719380|FG009|Participant Flow|Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123793|NCT01719380|OG000|Outcome|Phase 1b: LGX818 100 mg + Cetuximab|Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123794|NCT01719380|OG001|Outcome|Phase 1b: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123795|NCT01719380|OG002|Outcome|Phase 1b: LGX818 400 mg + Cetuximab|Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123796|NCT01719380|OG003|Outcome|Phase 1b: LGX818 450 mg + Cetuximab|Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123797|NCT01719380|OG004|Outcome|Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab|Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123798|NCT01719380|OG005|Outcome|Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab|Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123799|NCT01719380|OG006|Outcome|Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123800|NCT01719380|OG007|Outcome|Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab|Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123801|NCT01719380|OG000|Outcome|Phase 2: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123802|NCT01719380|OG001|Outcome|Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123803|NCT01719380|OG008|Outcome|Phase 2: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123804|NCT01719380|OG009|Outcome|Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123805|NCT01719380|OG000|Outcome|Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab|Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123806|NCT01719380|OG001|Outcome|Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab|Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123807|NCT01719380|OG002|Outcome|Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123808|NCT01719380|OG003|Outcome|Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab|Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123809|NCT01719380|OG004|Outcome|Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123810|NCT01719380|EG000|Reported Event|Phase 1b: LGX818 100 mg + Cetuximab|Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123811|NCT01719380|EG001|Reported Event|Phase 1b: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123812|NCT01719380|EG002|Reported Event|Phase 1b: LGX818 400 mg + Cetuximab|Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123813|NCT01719380|EG003|Reported Event|Phase 1b: LGX818 450 mg + Cetuximab|Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123814|NCT01719380|EG004|Reported Event|Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab|Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123815|NCT01719380|EG005|Reported Event|Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab|Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123816|NCT01719380|EG006|Reported Event|Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123817|NCT01719380|EG007|Reported Event|Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab|Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123818|NCT01719380|EG008|Reported Event|Phase 2: LGX818 200 mg + Cetuximab|Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123819|NCT01719380|EG009|Reported Event|Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab|Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
11123820|NCT01719653|BG000|Baseline|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123821|NCT01719653|BG001|Baseline|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123822|NCT01719653|BG002|Baseline|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123823|NCT01719653|BG003|Baseline|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
11123824|NCT01719653|BG004|Baseline|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
11123825|NCT01719653|BG005|Baseline|Total|Total of all reporting groups
11123826|NCT01719653|FG000|Participant Flow|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123827|NCT01719653|FG001|Participant Flow|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123828|NCT01719653|FG002|Participant Flow|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123829|NCT01719653|FG003|Participant Flow|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
11123830|NCT01719653|FG004|Participant Flow|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
11123831|NCT01719653|OG000|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123832|NCT01719653|OG001|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123833|NCT01719653|OG002|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123834|NCT01719653|OG003|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
11123835|NCT01719653|OG004|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
11123836|NCT01719653|EG000|Reported Event|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123837|NCT01719653|EG001|Reported Event|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123838|NCT01719653|EG002|Reported Event|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
11123839|NCT01719653|EG003|Reported Event|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
11123840|NCT01719653|EG004|Reported Event|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
11123841|NCT01719757|BG000|Baseline|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
11123842|NCT01719757|FG000|Participant Flow|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
11123843|NCT01719757|OG000|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
11123844|NCT01719757|OG000|Outcome|Investigator|For overall satisfaction assessement of oxycodone/naloxone by investigator
11123845|NCT01719757|OG001|Outcome|Subject|For overall satisfaction assessement of oxycodone/naloxone by subject
11123846|NCT01719757|EG000|Reported Event|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
11123847|NCT01719783|BG000|Baseline|LAIV H5N2|Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
11123848|NCT01719783|BG001|Baseline|Placebo|two doses of placebo solution intranasal
11123849|NCT01719783|BG002|Baseline|Total|Total of all reporting groups
11123850|NCT01719783|FG000|Participant Flow|LAIV H5N2|Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
11123851|NCT01719783|FG001|Participant Flow|Placebo|two doses of placebo solution provided intranasally
11123852|NCT01719783|OG000|Outcome|Dose 1: Vaccine|Received dose 1 of vaccine
11123853|NCT01719783|OG001|Outcome|Dose 1: Placebo|Received Dose 1 of Placebo
11123854|NCT01719783|OG002|Outcome|Dose 2: Vaccine|Received Dose 2 of vaccine
11123855|NCT01719783|OG003|Outcome|Dose 2: Placebo|Received Dose 2 of placebo
11123856|NCT01719783|OG000|Outcome|Day 1|Shedding 1 day after first dose was administered
11123857|NCT01719783|OG001|Outcome|Day 2|Shedding 2 days after first dose was administered
11123858|NCT01719783|OG002|Outcome|Day 3|Shedding 3 days after dose was administered
11123859|NCT01719783|OG003|Outcome|Day 4|Shedding 4 days after dose was administered
11123860|NCT01719783|OG004|Outcome|Day 5|Shedding 5 days after dose was administered
11123861|NCT01719783|OG005|Outcome|Day 6|Shedding 6 days after dose was administered
11123862|NCT01719783|OG000|Outcome|LAIV H5N2|Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
11123863|NCT01719783|OG001|Outcome|Placebo|two doses of placebo solution provided intranasally
11123864|NCT01719783|OG004|Outcome|Dose 1 or 2: Vaccine|Received dose 1 or 2 of vaccine
11123865|NCT01719783|OG005|Outcome|Dose 1 or 2: Placebo|Received dose 1 or 2 of placebo
11123866|NCT01719783|OG000|Outcome|Dose 1: Vaccine|After receiving dose 1 of vaccine
11123867|NCT01719783|OG001|Outcome|Dose 1: Placebo|After receiving Dose 1 of Placebo
11123868|NCT01719783|OG002|Outcome|Dose 2: Vaccine|After receiving Dose 2 of vaccine
11123869|NCT01719783|OG003|Outcome|Dose 2: Placebo|After receiving Dose 2 of placebo
11123870|NCT01719783|OG004|Outcome|Dose 1 or 2: Vaccine|After receiving dose 1 or 2 of vaccine
11123871|NCT01719783|OG005|Outcome|Dose 1 or 2: Placebo|After receiving dose 1 or 2 of placebo
11123872|NCT01719783|EG000|Reported Event|Dose 1: Vaccine|Received dose 1 of vaccine
11123873|NCT01719783|EG001|Reported Event|Dose 1: Placebo|Received Dose 1 of Placebo
11123874|NCT01719783|EG002|Reported Event|Dose 2: Vaccine|Received Dose 2 of vaccine
11123875|NCT01719783|EG003|Reported Event|Dose 2: Placebo|Received Dose 2 of placebo
11123876|NCT01719861|BG000|Baseline|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
11123877|NCT01719861|FG000|Participant Flow|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
11123878|NCT01719861|OG000|Outcome|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
11123879|NCT01719861|OG000|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
11123880|NCT01719861|EG000|Reported Event|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
11123881|NCT01719900|BG000|Baseline|Pulse Fibre|"The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.~Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving."
11123882|NCT01719900|BG001|Baseline|Control|"The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.~Control: Control biscuit with no yellow pea hull fibre."
11123883|NCT01719900|BG002|Baseline|Total|Total of all reporting groups
11123884|NCT01719900|FG000|Participant Flow|Pulse Fibre|"The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.~Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving."
11123885|NCT01719900|FG001|Participant Flow|Control|"The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.~Control: Control biscuit with no yellow pea hull fibre."
11123886|NCT01719900|OG000|Outcome|Pulse Fibre|"The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.~Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving."
11123887|NCT01719900|OG001|Outcome|Control|"The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.~Control: Control biscuit with no yellow pea hull fibre."
11123888|NCT01719900|EG000|Reported Event|Pulse Fibre|"The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.~Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving."
11123889|NCT01719900|EG001|Reported Event|Control|"The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.~Control: Control biscuit with no yellow pea hull fibre."
11126859|NCT01736085|EG005|Reported Event|Counseling Plus Patches|"Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.~Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling~Nicotine patches: Subjects will receive nicotine patches directly sent to their home.~Subj"
11126860|NCT01736124|BG000|Baseline|Computerized Cognitive Training (CCT)|Randomly selected subjects perform adaptive computerized cognitive training (CCT) program, CognifitTM], involving a variety of computer games tailored to address their personal cognitive deficits. Cognifit is a web-accessed CCT program designed to improve cognition by targeting the user's weaker cognitive functions. The challenge at each session was adapted according to the user's prior performance and a cognitive score pertaining to the specific session was provided. Participants were instructed to have sessions three times per week for eight weeks, with at least one day of rest between sessions, for a total of 24 sessions. Each 20 minute session included a unique combination of three games accessing a variety of cognitive abilities.
11126861|NCT01736124|BG001|Baseline|Active Control|As for the CCT intervention group, these randomly selected subjects performed three games each session from the same set of Cognifit computer games over the same eight week schedule. The activity differed only in the program did not target training games nor adaptive in their level of challenge based on prior performance and no cognitive score was provided at the end of the session.
11126862|NCT01736124|BG002|Baseline|Total|Total of all reporting groups
11126863|NCT01736124|FG000|Participant Flow|Computerized Cognitive Training (CCT)|"Randomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits.~computerized cognitive training: A variety of computer games tailored to address their personal cognitive deficits."
11126864|NCT01736124|FG001|Participant Flow|Active Control|"Randomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills.~control games: A variety of computer games that are engaging but not designed to enhance cognitive skills"
11126865|NCT01736124|OG000|Outcome|Adaptive CCT|Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
11126866|NCT01736124|OG001|Outcome|Active Control|Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
11126867|NCT01736124|OG000|Outcome|Computerized Cognitive Training (CCT)|"Randomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits.~computerized cognitive training: A variety of computer games tailored to address their personal cognitive deficits."
11123890|NCT01720043|BG000|Baseline|All Participants|"All participants enrolled~Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
11123891|NCT01720043|FG000|Participant Flow|All Participants|Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
11123892|NCT01720043|OG000|Outcome|All Participants|"All participants enrolled~Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
11123893|NCT01720043|EG000|Reported Event|All Participants|"All participants enrolled~Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
11123894|NCT01720069|BG000|Baseline|Dose 1 VR506 50 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123895|NCT01720069|BG001|Baseline|Dose 2 VR506 250 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123896|NCT01720069|BG002|Baseline|Dose 3 VR506 500 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123897|NCT01720069|BG003|Baseline|Total|Total of all reporting groups
11123898|NCT01720069|FG000|Participant Flow|Dose 1 VR506 50 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123899|NCT01720069|FG001|Participant Flow|Dose 2 VR506 250 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123900|NCT01720069|FG002|Participant Flow|Dose 3 VR506 500 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123901|NCT01720069|OG000|Outcome|Dose 1 VR506 50 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123902|NCT01720069|OG001|Outcome|Dose 2 VR506 250 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123903|NCT01720069|OG002|Outcome|Dose 3 VR506 500 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123904|NCT01720069|EG000|Reported Event|Dose 1 VR506 50 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123905|NCT01720069|EG001|Reported Event|Dose 2 VR506 250 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123906|NCT01720069|EG002|Reported Event|Dose 3 VR506 500 mcg|"VR506 inhalation powder delivered via a new dry powder inhaler device~VR506: VR506 inhalation powder delivered via a new dry powder inhaler device"
11123907|NCT01720173|BG000|Baseline|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
11123908|NCT01720173|FG000|Participant Flow|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
11123909|NCT01720173|OG000|Outcome|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
11123910|NCT01720173|EG000|Reported Event|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
11123911|NCT01720225|BG000|Baseline|Decitabine|"Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.~Decitabine: 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days."
11123912|NCT01720225|BG001|Baseline|Azacitidine|"Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.~Azacitidine: 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days."
11123913|NCT01720225|BG002|Baseline|Total|Total of all reporting groups
11123914|NCT01720225|FG000|Participant Flow|Decitabine|"Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.~Decitabine: 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days."
11123915|NCT01720225|FG001|Participant Flow|Azacitidine|"Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.~Azacitidine: 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days."
11123916|NCT01720225|OG000|Outcome|Decitabine|"Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.~Decitabine: 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days."
11123917|NCT01720225|OG001|Outcome|Azacitidine|"Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.~Azacitidine: 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days."
11123918|NCT01720225|EG000|Reported Event|Decitabine|"Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.~Decitabine: 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days."
11123919|NCT01720225|EG001|Reported Event|Azacitidine|"Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.~Azacitidine: 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days."
11123920|NCT01720251|BG000|Baseline|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
11123921|NCT01720251|BG001|Baseline|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
11123922|NCT01720251|BG002|Baseline|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
11123923|NCT01720251|BG003|Baseline|Total|Total of all reporting groups
11123924|NCT01720251|FG000|Participant Flow|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
11123925|NCT01720251|FG001|Participant Flow|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
11123926|NCT01720251|FG002|Participant Flow|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
11123927|NCT01720251|OG000|Outcome|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
11123928|NCT01720251|OG001|Outcome|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
11123929|NCT01720251|OG002|Outcome|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
11123930|NCT01720251|EG000|Reported Event|Placebo|All patients having received at least one injection of Placebo (Safety Set)
11123931|NCT01720251|EG001|Reported Event|Allert 50 µg|All patients having received at least one injection of Allert 50 µg (Safety Set)
11123932|NCT01720251|EG002|Reported Event|AllerT 100 µg|All patients having received at least one injection of Allert 100 µg (Safety Set)
11123933|NCT01720264|BG000|Baseline|Sitagliptin|Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
11123934|NCT01720264|FG000|Participant Flow|Sitagliptin|Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation (TBI) or Chemotherapy only.
11123935|NCT01720264|OG000|Outcome|Sitagliptin|Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
11123936|NCT01720264|EG000|Reported Event|Sitagliptin|Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
11123937|NCT01720277|BG000|Baseline|High-Dose Vaccine for Residents|NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
11123938|NCT01720277|BG001|Baseline|Standard-dose for Residents|NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
11123939|NCT01720277|BG002|Baseline|Total|Total of all reporting groups
11123940|NCT01720277|FG000|Participant Flow|High-Dose Vaccine for Residents|NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
11123941|NCT01720277|FG001|Participant Flow|Standard-dose for Residents|NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
11123942|NCT01720277|OG000|Outcome|High-Dose Vaccine for Residents|NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
11123943|NCT01720277|OG001|Outcome|Standard-dose for Residents|NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
11123944|NCT01720277|OG000|Outcome|HD Fluzone Vaccine|"NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.~HD Fluzone Vaccine: Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV)."
11123945|NCT01720277|OG001|Outcome|SD Fluzone Vaccine|"NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.~SD Fluzone Vaccine: Nursing home residents are allocated to receive standard trivalent vaccine (TIV)."
11123946|NCT01720277|EG000|Reported Event|High-Dose Vaccine for Residents|NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
11123947|NCT01720277|EG001|Reported Event|Standard-dose for Residents|NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
11123948|NCT01720316|BG000|Baseline|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
11123949|NCT01720316|BG001|Baseline|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
11123950|NCT01720316|BG002|Baseline|Total|Total of all reporting groups
11123951|NCT01720316|FG000|Participant Flow|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
11123952|NCT01720316|FG001|Participant Flow|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
11123953|NCT01720316|OG000|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
11123954|NCT01720316|OG001|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
11123955|NCT01720316|OG000|Outcome|Baseline|Composite Score at Baseline
11123956|NCT01720316|OG001|Outcome|Composite Score on Glycine, Double-blind|"Glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks Double-blind~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
11123957|NCT01720316|OG002|Outcome|Composite Score on Placebo|"placebo, TID dosing, 6 weeks Double-blind~placebo"
11123958|NCT01720316|OG003|Outcome|Composite Score on Glycine, Open-label|"glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
11006434|NCT01085825|FG000|Participant Flow|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
11006435|NCT01085825|FG001|Participant Flow|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
11006436|NCT01085825|OG000|Outcome|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
11006437|NCT01085825|OG001|Outcome|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
11006438|NCT01085825|EG000|Reported Event|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
11006439|NCT01085825|EG001|Reported Event|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
11006440|NCT01085903|BG000|Baseline|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
11006441|NCT01085903|BG001|Baseline|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline, CPS, and Post CPS and then are randomized to modafinil or placebo.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
11006442|NCT01085903|BG002|Baseline|Total|Total of all reporting groups
11006443|NCT01085903|FG000|Participant Flow|Normal Subjects Baseline|"Normal subjects are persons without stroke who receive baseline, Cold Pressor Stimulation (CPS), Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
11006444|NCT01085903|FG001|Participant Flow|Stroke Subjects: Placebo Then Modafinil|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
11006445|NCT01085903|FG002|Participant Flow|Stroke Subjects: Modafinil Then Placebo|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
11006446|NCT01085903|OG000|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."
11006447|NCT01085903|OG001|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."
11006448|NCT01085903|OG002|Outcome|Stroke Subjects: Modafinil|Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
11006449|NCT01085903|OG003|Outcome|Stroke Subjects: Placebo|Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
11006450|NCT01085903|OG004|Outcome|Stroke Subjects Placebo vs Modafinil|"Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
11006451|NCT01085903|OG001|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."
11006452|NCT01085903|OG002|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
11006453|NCT01085903|OG003|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
11123959|NCT01720316|OG000|Outcome|Glycine Then Placebo|"Glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks Double-blind~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
11123960|NCT01720316|OG001|Outcome|Placebo Then Glycine|"placebo, TID dosing, 6 weeks Double-blind~placebo"
11123961|NCT01720316|OG000|Outcome|Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine|Brain glycine/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
11123962|NCT01720316|OG001|Outcome|Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine|Brain glycine/CR ratio at baseline and week 6 of glycine for one participant
11123963|NCT01720316|OG000|Outcome|Subject1: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine|Brain glutamate/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
11123964|NCT01720316|OG001|Outcome|Subject2: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine|Brain glutamate/CR ratio at baseline and week 6 of glycine for one participant: Subject 2
11123965|NCT01720316|OG000|Outcome|Subject1: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine|Brain GABA/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
11123966|NCT01720316|OG001|Outcome|Subject2: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine|Brain GABA/CR ratio at baseline and week 6 of glycine for one participant: Subject 2
11123967|NCT01720316|OG000|Outcome|Auditory ERPs Latency (ms) Baseline: Subject 1|Subject1: Auditory ERPs (latency) baseline
11123968|NCT01720316|OG001|Outcome|Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (latency) week 6 of glycine
11123969|NCT01720316|OG002|Outcome|Auditory ERPs Latency (ms) Baseline: Subject 2|Subject2: Auditory ERPs (latency) baseline
11123970|NCT01720316|OG003|Outcome|Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (latency) week 6 of glycine
11123971|NCT01720316|OG000|Outcome|Glycine|"Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks~glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
11123972|NCT01720316|OG001|Outcome|Placebo|"placebo, TID dosing, 6 weeks~placebo"
11123973|NCT01720316|OG000|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 1|Subject1: Auditory ERPs (amplitude) baseline
11123974|NCT01720316|OG001|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (amplitude) week 6 of glycine
11123975|NCT01720316|OG002|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 2|Subject2: Auditory ERPs (amplitude) baseline
11123976|NCT01720316|OG003|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (amplitude) week 6 of glycine
11123977|NCT01720316|OG000|Outcome|Auditory ERPs Gamma Baseline: Subject 1|Subject1: Auditory ERPs (gamma phase locking) baseline
11123978|NCT01720316|OG001|Outcome|Auditory ERPs Gamma 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (gamma phase locking) week 6 of glycine
11123979|NCT01720316|OG002|Outcome|Auditory ERPs Gamma Baseline: Subject 2|Subject2: Auditory ERPs (gamma phase locking) baseline
11123980|NCT01720316|OG003|Outcome|Auditory ERPs Gamma 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (gamma phase locking) week 6 of glycine
11123981|NCT01720316|EG000|Reported Event|Glycine|"Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks~glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
11123982|NCT01720316|EG001|Reported Event|Placebo|"placebo, TID dosing, 6 weeks~placebo"
11123983|NCT01720446|BG000|Baseline|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
11123984|NCT01720446|BG001|Baseline|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123985|NCT01720446|BG002|Baseline|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
11123986|NCT01720446|BG003|Baseline|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123987|NCT01720446|BG004|Baseline|Total|Total of all reporting groups
11123988|NCT01720446|FG000|Participant Flow|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
11123989|NCT01720446|FG001|Participant Flow|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123990|NCT01720446|FG002|Participant Flow|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
11123991|NCT01720446|FG003|Participant Flow|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123992|NCT01720446|OG000|Outcome|Semaglutide|Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123993|NCT01720446|OG001|Outcome|Placebo|Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123994|NCT01720446|OG000|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
11123995|NCT01720446|OG001|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123996|NCT01720446|OG002|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
11123997|NCT01720446|OG003|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123998|NCT01720446|OG002|Outcome|Placebo|Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11123999|NCT01720446|EG000|Reported Event|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
11124000|NCT01720446|EG001|Reported Event|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11124001|NCT01720446|EG002|Reported Event|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
11124002|NCT01720446|EG003|Reported Event|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
11124003|NCT01720524|BG000|Baseline|IV Sildenafil|Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124004|NCT01720524|BG001|Baseline|Placebo|Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124005|NCT01720524|BG002|Baseline|Total|Total of all reporting groups
11124006|NCT01720524|FG000|Participant Flow|IV Sildenafil|Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124007|NCT01720524|FG001|Participant Flow|Placebo|Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124008|NCT01720524|OG000|Outcome|IV Sildenafil|Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124009|NCT01720524|OG001|Outcome|Placebo|Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124010|NCT01720524|EG000|Reported Event|Part A: IV Sildenafil|Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124011|NCT01720524|EG001|Reported Event|Part A: Placebo|Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124012|NCT01720524|EG002|Reported Event|Part B: IV Sildenafil|Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124013|NCT01720524|EG003|Reported Event|Part B: Placebo|Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
11124014|NCT01720602|BG000|Baseline|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
11124015|NCT01720602|FG000|Participant Flow|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
11124016|NCT01720602|OG000|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
11124017|NCT01720602|EG000|Reported Event|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
11124018|NCT01720667|BG000|Baseline|Intravenous Levetiracetam|"Intravenous levetiracetam 40 to 60 mg/kg loading dose. 10 mg/kg 8 hourly maintenance~Intravenous levetiracetam: Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure."
11124019|NCT01720667|BG001|Baseline|Intravenous Phenobarbital|"Intravenous phenobarbital 20 to 40 mg/kg load. 1.5 mg/kg 8 hourly maintenance~Intravenous phenobarbital: Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load."
11124020|NCT01720667|BG002|Baseline|Total|Total of all reporting groups
11124021|NCT01720667|FG000|Participant Flow|Intravenous Levetiracetam|Intravenous levetiracetam 40 - 60 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg LEV infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with PHB 20 mg/kg. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance LEV 10 mg/kg/dose given IV q8 hours continued for five days.
11124022|NCT01720667|FG001|Participant Flow|Intravenous Phenobarbital|Intravenous phenobarbital 20 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg PHB infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with LEV 40 mg/kg first. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance 1.5 mg/kg PHB mg/kg/dose given IV q8 hours continued for five days.
11124023|NCT01720667|OG000|Outcome|Intravenous Levetiracetam|Intravenous levetiracetam 40 - 60 mg/kg loading dose & 10 mg/kg 8 hourly maintenance
11124024|NCT01720667|OG001|Outcome|Intravenous Phenobarbital|Intravenous phenobarbital 20 - 40 mg/kg loading dose & 1.5 mg/kg 8 hourly maintenance.
11124025|NCT01720667|OG000|Outcome|Intravenous Levetiracetam|Intravenous levetiracetam 40 mg/kg loading dose & 10 mg/kg 8 hourly maintenance
11124026|NCT01720667|OG001|Outcome|Intravenous Phenobarbital|Intravenous phenobarbital 20 mg/kg loading dose & 1.5 mg/kg 8 hourly maintenance.
11124027|NCT01720667|EG000|Reported Event|Intravenous Phenobarbital|Intravenous phenobarbital 20 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg PHB infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with LEV 40 mg/kg first. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance 1.5 mg/kg PHB mg/kg/dose given IV q8 hours continued for five days.
11124028|NCT01720667|EG001|Reported Event|Intravenous Levetiracetam|Intravenous levetiracetam 40 - 60 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg LEV infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with PHB 20 mg/kg. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance LEV 10 mg/kg/dose given IV q8 hours continued for five days.
11124029|NCT01720797|BG000|Baseline|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
11124030|NCT01720797|BG001|Baseline|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
11124031|NCT01720797|BG002|Baseline|Total|Total of all reporting groups
11124032|NCT01720797|FG000|Participant Flow|Micro-osteoperforation|"Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.~Micro-osteoperforation: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.~Anesthestic: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.~Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
11124033|NCT01720797|FG001|Participant Flow|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
11124034|NCT01720797|OG000|Outcome|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
11124035|NCT01720797|OG001|Outcome|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
11124036|NCT01720797|EG000|Reported Event|Micro-osteoperforation|Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
11124037|NCT01720797|EG001|Reported Event|Non Micro-osteoperforation|"Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.~Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
11124038|NCT01721044|BG000|Baseline|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124039|NCT01721044|BG001|Baseline|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124040|NCT01721044|BG002|Baseline|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124041|NCT01721044|BG003|Baseline|Total|Total of all reporting groups
11124042|NCT01721044|FG000|Participant Flow|Placebo|Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
11124043|NCT01721044|FG001|Participant Flow|Baricitinib 2 mg|Baricitinib 2 milligram (mg) administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124044|NCT01721044|FG002|Participant Flow|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124045|NCT01721044|OG000|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124046|NCT01721044|OG001|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124047|NCT01721044|OG001|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124048|NCT01721044|OG002|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124049|NCT01721044|OG000|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
11124050|NCT01721044|OG001|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
11124051|NCT01721044|OG002|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
11124052|NCT01721044|OG001|Outcome|Baricitinib 2 mg|baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
11124053|NCT01721044|OG000|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group.~Participants continued to take background cDMARD therapy throughout study."
11124054|NCT01721044|OG001|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.~Participants continued to take background cDMARD therapy throughout study."
11124055|NCT01721044|EG000|Reported Event|Placebo -Treatment Period|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124056|NCT01721044|EG001|Reported Event|Baricitinib 2 mg - Treatment Period|Baricitinib 2mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124057|NCT01721044|EG002|Reported Event|Baricitinib 4 mg - Treatment Period|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124058|NCT01721044|EG003|Reported Event|Rescue Period|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124059|NCT01721044|EG004|Reported Event|Placebo - Follow Up Period|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11124060|NCT01721044|EG005|Reported Event|Baricitinib 2 mg - Follow Up Period|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11124061|NCT01721044|EG006|Reported Event|Baricitinib 4 mg - Follow Up Period|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11124062|NCT01721057|BG000|Baseline|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124063|NCT01721057|BG001|Baseline|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
11124064|NCT01721057|BG002|Baseline|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
11124065|NCT01721057|BG003|Baseline|Total|Total of all reporting groups
11124066|NCT01721057|FG000|Participant Flow|Placebo|"Placebo administered orally (PO) once daily (QD)through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
11124067|NCT01721057|FG001|Participant Flow|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124068|NCT01721057|FG002|Participant Flow|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124069|NCT01721057|FG003|Participant Flow|Rescue|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124070|NCT01721057|FG004|Participant Flow|Placebo-Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11124071|NCT01721057|FG005|Participant Flow|Baricitinib 2 mg- Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11124072|NCT01721057|FG006|Participant Flow|Baricitinib 4 mg- Follow Up|"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.~Includes participants who were rescued to Baricitinib 4 mg."
11124073|NCT01721057|OG000|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD)through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
11124074|NCT01721057|OG001|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124075|NCT01721057|OG002|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124076|NCT01721057|OG000|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
11124077|NCT01721057|OG001|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124078|NCT01721057|OG002|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124079|NCT01721057|OG000|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
11124080|NCT01721057|OG001|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continued to take background cDMARD therapy throughout study."
11124081|NCT01721057|OG002|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
11124082|NCT01721057|OG000|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
11124083|NCT01721057|OG001|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
11124084|NCT01721057|OG002|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
11124085|NCT01721057|OG000|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
11124086|NCT01721057|OG000|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
11124087|NCT01721057|OG002|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants will continue to take background cDMARD therapy throughout study."
11124088|NCT01721057|OG002|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24.~Participants will continue to take background cDMARD therapy throughout study."
11124089|NCT01721057|OG000|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
11124090|NCT01721057|OG001|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
11124091|NCT01721057|EG000|Reported Event|Placebo-Treatment Period|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
11124092|NCT01721057|EG001|Reported Event|Baricitinib 2 Mg-Treatment Period|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124093|NCT01721057|EG002|Reported Event|Baricitinib 4 Mg-Treatment Period|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
11124094|NCT01721057|EG003|Reported Event|Rescue|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
11124095|NCT01721057|EG004|Reported Event|Placebo-Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11124096|NCT01721057|EG005|Reported Event|Baricitinib 2 mg- Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
11124097|NCT01721057|EG006|Reported Event|Baricitinib 4 mg- Follow Up|"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.~Includes participants who were rescued to Baricitinib 4 mg."
11124098|NCT01721070|BG000|Baseline|SUF NT 15 mcg Then 3 Days of Ketoconazole and SUF NT 15 mcg|"Period 1: SUF NT 15 mcg administered once sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.~Period 2: Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
11124099|NCT01721070|FG000|Participant Flow|SUF NT 15 mcg Followed by Ketoconazole 400 mg + SUF NT 15 mcg|"Period 1: One SUF NT 15 mcg administered sublingually followed by Period 2.~Period 2: Ketoconazole 400 mg given daily for three days; One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT 15 mcg dosing to block the opioid effects of the sufentanil."
11124100|NCT01721070|OG000|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
11124101|NCT01721070|OG001|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given orally daily for three days. One SUF NT 15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
11124102|NCT01721070|OG001|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
11124103|NCT01721070|EG000|Reported Event|SUF NT 15 mcg|"One SUF NT 15 mcg administered sublingually.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
11124104|NCT01721070|EG001|Reported Event|Ketoconazole 400 mg + SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
11124105|NCT01721096|BG000|Baseline|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
11124106|NCT01721096|BG001|Baseline|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
11124107|NCT01721096|BG002|Baseline|Total|Total of all reporting groups
11124108|NCT01721096|FG000|Participant Flow|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
11124109|NCT01721096|FG001|Participant Flow|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
11124110|NCT01721096|OG000|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
11124111|NCT01721096|OG001|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
11124112|NCT01721096|OG000|Outcome|XIENCE PRIME - Long Length (LL)|"Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length).There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.~XIENCE PRIME - Long Length (LL): Long Length"
11124113|NCT01721096|OG001|Outcome|XIENCE PRIME - Core Size|"Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.~XIENCE PRIME - Core Size: Core Size"
11124114|NCT01721096|OG000|Outcome|XIENCE PRIME - Long Length (LL)|"Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.~."
11124115|NCT01721096|EG000|Reported Event|XIENCE PRIME - Long Length (LL) and Core Size (CS)|The study has 2 arms depending upon the size of stent used for the treatment: Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length), whereas Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
11124116|NCT01721109|BG000|Baseline|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
11124117|NCT01721109|FG000|Participant Flow|EVG/COBI/FTC/TDF|Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) (150/150/200/300 mg) single-tablet regimen (STR) administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase.
11124118|NCT01721109|OG000|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
11124119|NCT01721109|EG000|Reported Event|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
11124120|NCT01721161|BG000|Baseline|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124121|NCT01721161|BG001|Baseline|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124122|NCT01721161|BG002|Baseline|Total|Total of all reporting groups
11124123|NCT01721161|FG000|Participant Flow|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124124|NCT01721161|FG001|Participant Flow|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124125|NCT01721161|OG000|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124126|NCT01721161|OG001|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124127|NCT01721161|OG000|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124128|NCT01721161|EG000|Reported Event|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124129|NCT01721161|EG001|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
11124130|NCT01721200|BG000|Baseline|Decision Support Tool|"This study will examine the efficacy of a web-based educational decision support tool.~Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis"
11124131|NCT01721200|BG001|Baseline|Usual Care|"Usual Care Group will receive their biologic drug teaching from their rheumatologist.~Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care."
11124132|NCT01721200|BG002|Baseline|Total|Total of all reporting groups
11124133|NCT01721200|FG000|Participant Flow|Decision Support Tool|"This study will examine the efficacy of a web-based educational decision support tool.~Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis"
11124134|NCT01721200|FG001|Participant Flow|Usual Care|"Usual Care Group will receive their biologic drug teaching from their rheumatologist.~Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care."
11124135|NCT01721200|OG000|Outcome|Intervention Group|Randomized to view the decision support tool.
11124136|NCT01721200|OG001|Outcome|Control|Usual Care
11124137|NCT01721200|OG000|Outcome|1 Intervention|
11124138|NCT01721200|OG001|Outcome|Control|
11124139|NCT01721200|OG000|Outcome|Intervention Group|
11124140|NCT01721200|OG000|Outcome|Usual Care|"Usual Care Group will receive their biologic drug teaching from their rheumatologist.~Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care."
11124141|NCT01721200|OG001|Outcome|Decision Support Tool|"This study will examine the efficacy of a web-based educational decision support tool.~Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis"
11124142|NCT01721200|EG000|Reported Event|Usual Care|"Usual Care Group will receive their biologic drug teaching from their rheumatologist.~Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care."
11124143|NCT01721200|EG001|Reported Event|Decision Support Tool|"This study will examine the efficacy of a web-based educational decision support tool.~Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis"
11124144|NCT01721226|BG000|Baseline|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
11124145|NCT01721226|BG001|Baseline|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
11124146|NCT01721226|BG002|Baseline|Total|Total of all reporting groups
11124147|NCT01721226|FG000|Participant Flow|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
11124148|NCT01721226|FG001|Participant Flow|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
11124149|NCT01721226|OG000|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
11124150|NCT01721226|OG001|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
11124151|NCT01721226|EG000|Reported Event|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
11126868|NCT01736124|OG001|Outcome|Active Control|"Randomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills.~control games: A variety of computer games that are engaging but not designed to enhance cognitive skills"
11124152|NCT01721226|EG001|Reported Event|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
11124153|NCT01721317|BG000|Baseline|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
11124154|NCT01721317|BG001|Baseline|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
11124155|NCT01721317|BG002|Baseline|Total|Total of all reporting groups
11124156|NCT01721317|FG000|Participant Flow|Placebo|Participants received matching ezogabine/retigabine IR placebo orally three times a day (TID) in equally or unequally divided doses.
11124157|NCT01721317|FG001|Participant Flow|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 milligrams (mg)/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
11124158|NCT01721317|OG000|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
11124159|NCT01721317|OG001|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
11124160|NCT01721317|EG000|Reported Event|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
11124161|NCT01721317|EG001|Reported Event|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
11124162|NCT01721330|BG000|Baseline|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
11124163|NCT01721330|BG001|Baseline|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
11124164|NCT01721330|BG002|Baseline|Total|Total of all reporting groups
11124165|NCT01721330|FG000|Participant Flow|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
11124166|NCT01721330|FG001|Participant Flow|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
11124167|NCT01721330|OG000|Outcome|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
11124168|NCT01721330|OG001|Outcome|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
11124169|NCT01721330|EG000|Reported Event|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
11124170|NCT01721330|EG001|Reported Event|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
11124171|NCT01721369|BG000|Baseline|Transient Loss of Consciousness (T-LOC)|Patients with transient loss of consciousness (T-LOC)
11124172|NCT01721369|FG000|Participant Flow|Transient Loss of Consciousness (T-LOC)|Patient with transient loss of consciousness (T-LOC)
11124173|NCT01721369|OG000|Outcome|Transient Loss of Consciousness (T-LOC)|Patients with transient loss of consciousness (T-LOC)
11124174|NCT01721369|EG000|Reported Event|Transient Loss of Consciousness (T-LOC)|Patient with transient loss of consciousness (T-LOC)
11124175|NCT01721408|BG000|Baseline|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
11124176|NCT01721408|BG001|Baseline|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
11124177|NCT01721408|BG002|Baseline|Total|Total of all reporting groups
11124178|NCT01721408|FG000|Participant Flow|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
11124179|NCT01721408|FG001|Participant Flow|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
11124180|NCT01721408|OG000|Outcome|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
11124181|NCT01721408|OG001|Outcome|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
11124182|NCT01721408|EG000|Reported Event|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
11124183|NCT01721408|EG001|Reported Event|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
11124184|NCT01721447|BG000|Baseline|Echo Arm|"Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent~Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus."
11124185|NCT01721447|FG000|Participant Flow|Echo Arm|"Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent~Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus."
11124186|NCT01721447|OG000|Outcome|Pre-Contrast|Standard trans-esophageal echocardiography imaging prior to injection of Optison contrast
11124187|NCT01721447|OG001|Outcome|Post-Contrast|Trans-esophageal echocardiography imaging following injection of Optison contrast
11124188|NCT01721447|EG000|Reported Event|Echo Arm|"Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent~Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus."
11124189|NCT01721460|BG000|Baseline|Dexmedetomidine During MER|"Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.~Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved."
11124190|NCT01721460|FG000|Participant Flow|Dexmedetomidine During MER|"Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.~Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved."
11124191|NCT01721460|OG000|Outcome|Dexmedetomidine Modulation of MER|Change in RMS value between baseline (awake) and maximal sedation during dexmedetomidine administration.
11124192|NCT01721460|OG000|Outcome|Dexmedetomidine During MER|"Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.~Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved."
11124193|NCT01721460|OG000|Outcome|Dexmedetomidine During MER|Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.
11124194|NCT01721460|EG000|Reported Event|Treatment|"Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.~Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved."
11124195|NCT01721473|BG000|Baseline|Non-smokers|People who did not smoke.
11124196|NCT01721473|BG001|Baseline|Smokers Methol|People who smoke menthol cigarettes.
11124197|NCT01721473|BG002|Baseline|Smokers Non Menthol|People who smoke non menthol cigarettes.
11124198|NCT01721473|BG003|Baseline|Smokers Without Comorbidities|People who smoke but do not have heavy caffeine or marijuana use.
11124199|NCT01721473|BG004|Baseline|Smokers With Caffeine|People who smoke and have heavy caffeine use.
11124200|NCT01721473|BG005|Baseline|Smokers With Marijuana|People who smoke who have heavy marijuana use
11124201|NCT01721473|BG006|Baseline|Total|Total of all reporting groups
11124202|NCT01721473|FG000|Participant Flow|Non-smokers|People who did not smoke or use heavy caffeine or marijuana
11124203|NCT01721473|FG001|Participant Flow|Menthol Smokers|People who smoke menthol cigarettes.
11124204|NCT01721473|FG002|Participant Flow|Non-menthol Smokers|People who smoke non-menthol cigarettes
11124205|NCT01721473|FG003|Participant Flow|Smokers Without Comorbidities|People who smoke without heavy caffeine or marijuana use.
11124206|NCT01721473|FG004|Participant Flow|Smokers With Caffeine|People who smoke and have heavy caffeine use.
11124207|NCT01721473|FG005|Participant Flow|Smokers With Marijuana|People who smoke and heavily use marijuana.
11124208|NCT01721473|OG000|Outcome|Smoker vs. Non Smoker|menthol smoker vs. non-menthol smoker vs. non smoker (w/o caffeine and marijuana) vs. smoker (w/o caffeine and marijuana) vs. smoker w/ caffeine use vs. smoker w/ marijuana use
11124209|NCT01721473|EG000|Reported Event|Non-smokers|Participants who did not smoke.
11124210|NCT01721473|EG001|Reported Event|Smokers Methol|Participants who smoked menthol cigarettes.
11124211|NCT01721473|EG002|Reported Event|Smokers Non Menthol|Participants who smoked non menthol cigarettes
11124212|NCT01721473|EG003|Reported Event|Smokers Without Comorbidities|Participants who smoked without heavy use of caffeine or marijuana.
11124213|NCT01721473|EG004|Reported Event|Smokers With Caffeine|Participants who smoked with heavy caffeine use.
11124214|NCT01721473|EG005|Reported Event|Smokers With Marijuana|Participants who smoked with heavy marijuana use.
11124215|NCT01721486|BG000|Baseline|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
11124216|NCT01721486|BG001|Baseline|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
11124217|NCT01721486|BG002|Baseline|Total|Total of all reporting groups
11124218|NCT01721486|FG000|Participant Flow|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
11124219|NCT01721486|FG001|Participant Flow|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
11124220|NCT01721486|OG000|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
11124221|NCT01721486|OG001|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
11124222|NCT01721486|EG000|Reported Event|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
11124223|NCT01721486|EG001|Reported Event|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
11124224|NCT01721564|BG000|Baseline|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
11124225|NCT01721564|FG000|Participant Flow|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
11124226|NCT01721564|OG000|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
11124227|NCT01721564|EG000|Reported Event|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
11124228|NCT01721603|BG000|Baseline|Dabrafenib Given in Combination With Gamma Knife Radiosurgery|"All patients will receive continuous, oral dosing of dabrafenib at a starting dose of 150 mg twice daily until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity~Dabrafenib: 150mg capsule by mouth twice daily~Gamma Knife Radiosurgery: This will be delivered using Gamma Knife technology. Patients will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases."
11124229|NCT01721603|FG000|Participant Flow|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
11124230|NCT01721603|OG000|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
11124231|NCT01721603|EG000|Reported Event|Dabrafenib With Gamma Knife Radiosurgery|"Dabrafenib: 150mg capsule by mouth twice daily until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity~Gamma Knife Radiosurgery: This will be delivered using Gamma Knife technology. Patients will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases."
11124232|NCT01721681|BG000|Baseline|Human Coagulation FACTOR X|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
11124233|NCT01721681|FG000|Participant Flow|Overall Study|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
11124234|NCT01721681|OG000|Outcome|Overall Study|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
11124235|NCT01721681|EG000|Reported Event|Human Coagulation FACTOR X|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
11124236|NCT01721772|BG000|Baseline|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
11124237|NCT01721772|BG001|Baseline|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
11124238|NCT01721772|BG002|Baseline|Total|Total of all reporting groups
11124239|NCT01721772|FG000|Participant Flow|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
11124240|NCT01721772|FG001|Participant Flow|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
11124241|NCT01721772|OG000|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
11124242|NCT01721772|OG001|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
11124243|NCT01721772|EG000|Reported Event|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
11124244|NCT01721772|EG001|Reported Event|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
11124245|NCT01721837|BG000|Baseline|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
11124246|NCT01721837|FG000|Participant Flow|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).
11124247|NCT01721837|OG000|Outcome|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
11124248|NCT01721837|EG000|Reported Event|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
11124249|NCT01721876|BG000|Baseline|Placebo + Low-dose Cytarabine|Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
11124250|NCT01721876|BG001|Baseline|Volasertib + Low-dose Cytarabine|Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
11124251|NCT01721876|BG002|Baseline|Total|Total of all reporting groups
11124252|NCT01721876|FG000|Participant Flow|Placebo + Low-dose Cytarabine|Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
11124253|NCT01721876|FG001|Participant Flow|Volasertib + Low-dose Cytarabine|Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
11124254|NCT01721876|OG000|Outcome|Placebo + Low-dose Cytarabine|Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
11124255|NCT01721876|OG001|Outcome|Volasertib + Low-dose Cytarabine|Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
11124256|NCT01721876|EG000|Reported Event|Subjects Assigned to Placebo + Low-dose Cytarabine|Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
11124257|NCT01721876|EG001|Reported Event|Subjects Assigned to Volasertib + Low-dose Cytarabine|Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.
11124258|NCT01721954|BG000|Baseline|mFOLFOX6 Plus SIRT|"Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.~FOLFOX6m~SIR-Spheres microspheres"
11124259|NCT01721954|BG001|Baseline|mFOLFOX6 Alone|"Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.~FOLFOX6m"
11124260|NCT01721954|BG002|Baseline|Total|Total of all reporting groups
11124261|NCT01721954|FG000|Participant Flow|mFOLFOX6 Plus SIRT|"Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.~FOLFOX6m~SIR-Spheres microspheres"
11124262|NCT01721954|FG001|Participant Flow|mFOLFOX6 Alone|"Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.~FOLFOX6m"
11124263|NCT01721954|OG000|Outcome|mFOLFOX6 Plus SIRT|"Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.~FOLFOX6m~SIR-Spheres microspheres"
11124264|NCT01721954|OG001|Outcome|mFOLFOX6 Alone|"Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.~FOLFOX6m"
11124265|NCT01721954|EG000|Reported Event|mFOLFOX6 Plus SIRT|"Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.~FOLFOX6m~SIR-Spheres microspheres"
11124266|NCT01721954|EG001|Reported Event|mFOLFOX6 Alone|"Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.~FOLFOX6m"
11124267|NCT01721967|BG000|Baseline|Ranolazine|Ranolazine, 500 mg for 60 days
11124268|NCT01721967|FG000|Participant Flow|Ranolazine|Ranolazine, 500 mg for 60 days
11006454|NCT01085903|OG004|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
11006455|NCT01085903|OG001|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."
11006456|NCT01085903|OG002|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
11006457|NCT01085903|OG003|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
11006458|NCT01085903|OG004|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
11006459|NCT01085903|OG000|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline and CPS conditions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."
11006460|NCT01085903|OG004|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patientseal for three days administered only to stroke patients"
11006461|NCT01085903|EG000|Reported Event|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months"
11006462|NCT01085903|EG001|Reported Event|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months"
11006463|NCT01085968|BG000|Baseline|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
11006464|NCT01085968|BG001|Baseline|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
11006465|NCT01085968|BG002|Baseline|Total|Total of all reporting groups
11006466|NCT01085968|FG000|Participant Flow|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
11006467|NCT01085968|FG001|Participant Flow|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
11006468|NCT01085968|OG000|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
11006469|NCT01085968|OG001|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
11006470|NCT01085968|EG000|Reported Event|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
11006471|NCT01085968|EG001|Reported Event|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
11006472|NCT01086033|BG000|Baseline|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
11124269|NCT01721967|OG000|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
11124270|NCT01721967|EG000|Reported Event|Ranolazine|Ranolazine, 500 mg for 60 days
11124271|NCT01722045|BG000|Baseline|Open Label IAI|Intravitreal Aflibercept Injection (IAI)
11124272|NCT01722045|FG000|Participant Flow|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
11124273|NCT01722045|OG000|Outcome|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
11124274|NCT01722045|EG000|Reported Event|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
11124275|NCT01722071|BG000|Baseline|Participants|Each participant will complete baseline assessments prior to being studied using fMRI
11124276|NCT01722071|FG000|Participant Flow|Placebo Then Oxytocin|"These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin).~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
11124277|NCT01722071|FG001|Participant Flow|Oxytocin Then Placebo|"These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo).~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
11124278|NCT01722071|OG000|Outcome|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
11124279|NCT01722071|OG001|Outcome|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
11124280|NCT01722071|EG000|Reported Event|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
11124281|NCT01722071|EG001|Reported Event|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
11124282|NCT01722097|BG000|Baseline|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
11124283|NCT01722097|BG001|Baseline|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
11124284|NCT01722097|BG002|Baseline|Total|Total of all reporting groups
11124285|NCT01722097|FG000|Participant Flow|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
11124286|NCT01722097|FG001|Participant Flow|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
11124287|NCT01722097|OG000|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
11124288|NCT01722097|OG001|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
11124289|NCT01722097|EG000|Reported Event|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
11124290|NCT01722097|EG001|Reported Event|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
11124291|NCT01722162|BG000|Baseline|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
11124292|NCT01722162|BG001|Baseline|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
11124293|NCT01722162|BG002|Baseline|Total|Total of all reporting groups
11124294|NCT01722162|FG000|Participant Flow|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
11124295|NCT01722162|FG001|Participant Flow|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
11124296|NCT01722162|OG000|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
11124297|NCT01722162|OG001|Outcome|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
11124298|NCT01722162|EG000|Reported Event|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
11124299|NCT01722162|EG001|Reported Event|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
11124300|NCT01722266|BG000|Baseline|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
11124301|NCT01722266|BG001|Baseline|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124302|NCT01722266|BG002|Baseline|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124303|NCT01722266|BG003|Baseline|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124304|NCT01722266|BG004|Baseline|Total|Total of all reporting groups
11124305|NCT01722266|FG000|Participant Flow|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
11124306|NCT01722266|FG001|Participant Flow|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124307|NCT01722266|FG002|Participant Flow|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124308|NCT01722266|FG003|Participant Flow|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124309|NCT01722266|OG000|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
11124310|NCT01722266|OG001|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124311|NCT01722266|OG002|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124312|NCT01722266|OG003|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124313|NCT01722266|EG000|Reported Event|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
11124314|NCT01722266|EG001|Reported Event|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11006473|NCT01086033|FG000|Participant Flow|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
11006474|NCT01086033|OG000|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
11006475|NCT01086033|OG000|Outcome|Good Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Good Response per EULAR criteria.
11006476|NCT01086033|OG001|Outcome|Moderate Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
11006477|NCT01086033|OG002|Outcome|No Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
11006478|NCT01086033|EG000|Reported Event|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
11006479|NCT01086150|BG000|Baseline|Healthy Control Patients|"Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006480|NCT01086150|BG001|Baseline|Type I or Type II Diabetes With Painful Diabetic Neuropathy|"18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006481|NCT01086150|BG002|Baseline|Patients With Non-painful Diabetic Peripheral Neuropathy|"18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006482|NCT01086150|BG003|Baseline|Total|Total of all reporting groups
11006483|NCT01086150|FG000|Participant Flow|Healthy Control Patients|"Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006484|NCT01086150|FG001|Participant Flow|Type I or Type II Diabetes With Painful Diabetic Neuropathy|"18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006485|NCT01086150|FG002|Participant Flow|Patients With Non-painful Diabetic Peripheral Neuropathy|"18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006486|NCT01086150|OG000|Outcome|Healthy Control Patients|"Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006487|NCT01086150|OG001|Outcome|Type I or Type II Diabetes With Painful Diabetic Neuropathy|"18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006488|NCT01086150|OG002|Outcome|Patients With Non-painful Diabetic Peripheral Neuropathy|"18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006489|NCT01086150|EG000|Reported Event|Healthy Control Patients|"Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006490|NCT01086150|EG001|Reported Event|Type I or Type II Diabetes With Painful Diabetic Neuropathy|"18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11124315|NCT01722266|EG002|Reported Event|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124316|NCT01722266|EG003|Reported Event|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
11124317|NCT01722292|BG000|Baseline|Phase 1b: 100 mg LY2940680 + C +E|"100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.~Maintenance:~Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation."
11124318|NCT01722292|BG001|Baseline|Phase 1b: 200 mg LY2940680 + C + E|"200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.~Maintenance:~Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation."
11124319|NCT01722292|BG002|Baseline|Phase 1b: 400 mg LY2940680 + C + E|"400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.~Maintenance:~Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation."
11124320|NCT01722292|BG003|Baseline|Total|Total of all reporting groups
11124321|NCT01722292|FG000|Participant Flow|Phase 1b: 100 mg LY2940680 + C + E|"100 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.~Maintenance:~Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation."
11124322|NCT01722292|FG001|Participant Flow|Phase 1b: 200 mg LY2940680 + C + E|"200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.~Maintenance:~Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation."
11124323|NCT01722292|FG002|Participant Flow|Phase 1B: 400 mg LY2940680 + C + E|"400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.~Maintenance:~Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation."
11124324|NCT01722292|OG000|Outcome|Phase 1b|"Cohort 1:~100 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.~Cohort 2:~200 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.~Cohort 3:~400 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124325|NCT01722292|OG000|Outcome|Phase 2: 400 mg LY2940680 + C+ E|"400 mg LY2940680 administered orally QD cycles 1-6 (21 day cycle).~(AUC) 5 carboplatin (C) administered by IV infusion on day 1 each cycle.~100 mg/m^2 etoposide (E) administered by IV infusion on days 1, 2, 3 of each cycle, followed by a single agent of LY2940680."
11124326|NCT01722292|OG001|Outcome|Phase 2: Placebo + C + E|"Placebo administered orally QD for 6 cycles.~(AUC) 5 carboplatin administered by IV infusion on day 1 of each cycle.~100 mg/m^2 etoposide administered by IV infusion on days 1, 2, 3 of each cycle."
11124327|NCT01722292|OG000|Outcome|Phase 1b: 100 mg LY2940680 + C + E|"100 mg LY2940680 administered orally once daily (QD) for 6 cycles.~100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124328|NCT01722292|OG001|Outcome|Phase 1b: 200 mg LY2940680 + C + E|"200 mg LY2940680 administered orally once daily (QD) for 6 cycles.~100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124329|NCT01722292|OG002|Outcome|Phase 1B: 400 mg LY2940680 + C + E|"400 mg LY2940680 administered orally once daily (QD) for 6 cycles.~100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124330|NCT01722292|OG000|Outcome|Phase 1b: LY2940680 + C + E|"LY2940680 administered orally once daily (QD) for 6 cycles.~100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124331|NCT01722292|OG000|Outcome|Phase 1b: 100 mg LY2940680 + C+ E|"100 mg LY2940680 administered orally once daily (QD) for 6 cycles.~100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124332|NCT01722292|OG001|Outcome|Phase 1b: 200 mg LY2940680 + C+ E|"200 mg LY2940680 administered orally once daily (QD) for 6 cycles.~100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124333|NCT01722292|OG002|Outcome|Phase 1b: 400 mg LY2940680 + C+ E|"400 mg LY2940680 administered orally once daily (QD) for 6 cycles.~100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124334|NCT01722292|OG000|Outcome|Phase 1b: LY2940680 + C+ E|"LY2940680 administered orally once daily (QD) for 6 cycles.~100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124335|NCT01722292|OG000|Outcome|Phase 1b: 100 mg LY2940680 + C+ E|"100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124336|NCT01722292|OG001|Outcome|Phase 1b: 200 mg LY2940680 + C+ E|"200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124337|NCT01722292|OG002|Outcome|Phase 1b: 400 mg LY2940680 + C+ E|"400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124338|NCT01722292|OG000|Outcome|Phase 1b: 100 mg LY2940680|"100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124339|NCT01722292|OG001|Outcome|Phase 1b: 200 mg LY2940680|"200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124340|NCT01722292|OG002|Outcome|Phase 1b: 400 mg LY2940680|"400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124341|NCT01722292|OG000|Outcome|Phase 2: 400 mg LY2940680 + C+ E|"400 mg LY2940680 administered orally QD cycles 1-6 (21 day cycle)~(AUC) 5 carboplatin (C) administered by IV infusion on day 1 each cycle.~100 mg/m^2 etoposide (E) administered by IV infusion on days 1, 2, 3 of each cycle, followed by a single agent of LY2940680."
11124342|NCT01722292|OG000|Outcome|Phase 2: Placebo + C + E|"Induction: Cycles 1-6 (21 day cycles) Placebo administered orally once daily in combination with etoposide 100 mg/m^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.~Maintenance: Cycles 7+ (21 day cycles) Placebo administered orally once daily. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation."
11124343|NCT01722292|OG001|Outcome|Phase 2: LY2940680 + C+ E|"Induction: Cycles 1-6 (21 day cycles) LY2940680 (dose to be determined in Phase 1b portion) administered orally once daily in combination with etoposide 100 mg/m^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.~Maintenance: Cycles 7+ (21 day cycles). LY2940680 (dose to be determined in Phase 1 portion) administered orally once daily."
11124344|NCT01722292|EG000|Reported Event|Phase 1b: 100 mg LY2940680 + C + E|"100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124345|NCT01722292|EG001|Reported Event|Phase 1b: 200 mg LY2940680 + C + E|"200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124346|NCT01722292|EG002|Reported Event|Phase 1b: 400 mg LY2940680 + C + E|"400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.~Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle."
11124347|NCT01722318|BG000|Baseline|Plecanatide 0.3mg|"Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124348|NCT01722318|BG001|Baseline|Plecanatide 1.0mg|"Plecanatide 1.0mg one tablet by mouth daily for 12 weeks~Plecanatide"
11124349|NCT01722318|BG002|Baseline|Plecanatide 3.0mg|"Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124350|NCT01722318|BG003|Baseline|Plecanatide 9.0mg|"Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124351|NCT01722318|BG004|Baseline|Placebo|"Placebo, one tablet by mouth daily for 12 weeks~Placebo"
11124352|NCT01722318|BG005|Baseline|Total|Total of all reporting groups
11124353|NCT01722318|FG000|Participant Flow|Plecanatide 0.3mg|"Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124354|NCT01722318|FG001|Participant Flow|Plecanatide 1.0mg|"Plecanatide 1.0mg one tablet by mouth daily for 12 weeks~Plecanatide"
11124355|NCT01722318|FG002|Participant Flow|Plecanatide 3.0mg|"Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124356|NCT01722318|FG003|Participant Flow|Plecanatide 9.0mg|"Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124357|NCT01722318|FG004|Participant Flow|Placebo|"Placebo, one tablet by mouth daily for 12 weeks~Placebo"
11124358|NCT01722318|OG000|Outcome|Plecanatide 0.3mg|Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
11124359|NCT01722318|OG001|Outcome|Plecanatide 1.0mg|Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
11124360|NCT01722318|OG002|Outcome|Plecanatide 3.0mg|Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
11124361|NCT01722318|OG003|Outcome|Plecanatide 9.0mg|Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
11124362|NCT01722318|OG004|Outcome|Placebo|Placebo, one tablet by mouth daily for 12 weeks
11124363|NCT01722318|EG000|Reported Event|Plecanatide 0.3mg|"Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124364|NCT01722318|EG001|Reported Event|Plecanatide 1.0mg|"Plecanatide 1.0mg one tablet by mouth daily for 12 weeks~Plecanatide"
11124365|NCT01722318|EG002|Reported Event|Plecanatide 3.0mg|"Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124366|NCT01722318|EG003|Reported Event|Plecanatide 9.0mg|"Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks~Plecanatide"
11124367|NCT01722318|EG004|Reported Event|Placebo|"Placebo, one tablet by mouth daily for 12 weeks~Placebo"
11124368|NCT01722435|BG000|Baseline|OST Completers|"The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients' state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or - if patients stayed in treatment - at the end of the 18-months study period).~At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone)."
11124369|NCT01722435|FG000|Participant Flow|OST Completers|"Patients who are likely to complete OST during the next 12 or 18 months~Opiate Substitution Treatment"
10846081|NCT00272961|FG004|Participant Flow|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
11124370|NCT01722435|OG000|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
11124371|NCT01722435|OG000|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months.
11124372|NCT01722435|OG000|Outcome|OST Completers|Patients completed OST during 12 or 18 months.
11124373|NCT01722435|OG000|Outcome|OST Drop-outs|Patients dropped out of OST during 12 or 18 months.
11124374|NCT01722435|OG000|Outcome|Still in OST Completers|Patients still in OST during the whole study period.
11124375|NCT01722435|EG000|Reported Event|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
11124376|NCT01722487|BG000|Baseline|Ibrutinib|Ibrutinib 420 mg daily.
11124377|NCT01722487|BG001|Baseline|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
11124378|NCT01722487|BG002|Baseline|Total|Total of all reporting groups
11124379|NCT01722487|FG000|Participant Flow|Ibrutinib|Ibrutinib 420 mg daily.
11124380|NCT01722487|FG001|Participant Flow|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
11124381|NCT01722487|OG000|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
11124382|NCT01722487|OG001|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
11124383|NCT01722487|OG001|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
11124384|NCT01722487|EG000|Reported Event|PCI-32765|Ibrutinib 420 mg daily.
11124385|NCT01722487|EG001|Reported Event|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
11124386|NCT01722552|BG000|Baseline|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
11124387|NCT01722552|FG000|Participant Flow|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
11124388|NCT01722552|OG000|Outcome|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
11124389|NCT01722552|OG001|Outcome|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
11124390|NCT01722552|EG000|Reported Event|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
11124391|NCT01722552|EG001|Reported Event|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
11124392|NCT01722604|BG000|Baseline|Brinzolamide 1% Ophthalmic Suspension|"ophthalmic suspension~brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension"
11124393|NCT01722604|BG001|Baseline|Azopt 1% Ophthalmic Suspension|"Ophthalmic suspension~Azopt 1%: Azopt 1%, RLD"
11124394|NCT01722604|BG002|Baseline|Total|Total of all reporting groups
11124395|NCT01722604|FG000|Participant Flow|Brinzolamide 1% Ophthalmic Suspension|"ophthalmic suspension~brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension"
11124396|NCT01722604|FG001|Participant Flow|Azopt 1% Ophthalmic Suspension|"Ophthalmic suspension~Azopt 1%: Azopt 1%, RLD"
11124397|NCT01722604|OG000|Outcome|Brinzolamide 1% Ophthalmic Suspension|"ophthalmic suspension~brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension"
11124398|NCT01722604|OG001|Outcome|Azopt 1% Ophthalmic Suspension|"Ophthalmic suspension~Azopt 1%: Azopt 1%, RLD"
11124399|NCT01722604|EG000|Reported Event|Brinzolamide 1% Ophthalmic Suspension|"ophthalmic suspension~brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension"
11124400|NCT01722604|EG001|Reported Event|Azopt 1% Ophthalmic Suspension|"Ophthalmic suspension~Azopt 1%: Azopt 1%, RLD"
11124401|NCT01722643|BG000|Baseline|MAxIM|This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.
11124402|NCT01722643|BG001|Baseline|Usual Care|Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
11124403|NCT01722643|BG002|Baseline|Total|Total of all reporting groups
11124404|NCT01722643|FG000|Participant Flow|MAxIM|This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.
10846082|NCT00272961|OG000|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
11124405|NCT01722643|FG001|Participant Flow|Usual Care|Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
11124406|NCT01722643|OG000|Outcome|MAxIM|This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.
11124407|NCT01722643|OG001|Outcome|Usual Care|Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
11124408|NCT01722643|EG000|Reported Event|MAxIM|This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.
11124409|NCT01722643|EG001|Reported Event|Usual Care|Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
11124410|NCT01722669|BG000|Baseline|Quercetin 500 mg (ARM A1)|Single dose of quercetin PK/PD analysis
11124411|NCT01722669|BG001|Baseline|Isoquercetin 500 mg (ARM B1)|Single dose of isoquercetin PK/PD analysis
11124412|NCT01722669|BG002|Baseline|Quercetin 500 mg + Ascorbic Acid (ARM A2)|Single dose of quercetin + ascorbic acid PK/PD analysis
11124413|NCT01722669|BG003|Baseline|Isoquercetin 500 mg + Ascorbic Acid (ARM B2)|Single dose of isqouercetin +ascorbic acid PK/PD analysis
11124414|NCT01722669|BG004|Baseline|Isoquercetin 1000 mg + Ascorbic Acid (ARM C)|single dose isoquercetin + ascorbic acid PK/PD analyses
11124415|NCT01722669|BG005|Baseline|Antiphospholipid Antibody (ARM D)|single dose isoquercetin +ascorbic acid in patients with antiphospholipid antibodies
11124416|NCT01722669|BG006|Baseline|Total|Total of all reporting groups
11124417|NCT01722669|FG000|Participant Flow|Quercetin 500mg (ARM A1)|Single dose PK/PD analyses of quercetin 500 mg
11124418|NCT01722669|FG001|Participant Flow|Isoquercetin 500mg (ARM B1)|Single dose PK/PD of isoquercetin 500 mg
11124419|NCT01722669|FG002|Participant Flow|Quercetin 500 mg + Ascorbic Acid (ARM A2)|Single dose quercetin with 500 mg + ascorbic acid pk/pd analyses
11124420|NCT01722669|FG003|Participant Flow|Isoquercetin 500 mg + Ascorbic Acid (ARM B2)|Single dose isoquercetin 500 mg + ascorbic acid pk/pd analyses
11124421|NCT01722669|FG004|Participant Flow|Isoquercetin 1000 mg + Ascorbic Acid (ARM C)|Single dose isoquercetin + 1000 mg ascorbic acid
11124422|NCT01722669|FG005|Participant Flow|Antiphospholipid Antibody Cohort (ARM D)|Single dose isoquercetin 1000 mg + 1000 mg ascorbic acid in patients with antiphospholipid antibodies
11124423|NCT01722669|OG000|Outcome|Quercetin 500 mg (ARM A1)|Single dose, measurement of plasma quercetin aglycone
11124424|NCT01722669|OG001|Outcome|Isoquercetin 500 mg (ARM B1)|Single dose, measurement of plasma quercetin aglycone
11124425|NCT01722669|OG002|Outcome|Quercetin 500 mg + Ascorbic Acid (ARM A2)|Single dose, measurement of plasma quercetin aglycone
11124426|NCT01722669|OG003|Outcome|Isoquercetin 500 mg + Ascorbic Acid (ARM B2)|Single dose, measurement of plasma quercetin aglycone
11124427|NCT01722669|OG004|Outcome|Isoquercetin 1000 mg + Ascorbic Acid (ARM C)|Single dose, measurement of plasma quercetin aglycone
11124428|NCT01722669|OG000|Outcome|Quercetin 500 mg (ARM A1)|PDI activity measured by DiESSG assay at 0 and 2 hours
11124429|NCT01722669|OG001|Outcome|Isoquercetin 500 mg (ARM B1)|PDI activity measured by DiESSG assay at 0 and 2 hours
11124430|NCT01722669|OG002|Outcome|Quercetin 500 mg + Ascorbic Acid (ARM A2)|PDI activity measured by DiESSG assay at 0 and 2 hours
11124431|NCT01722669|OG003|Outcome|Isoquercetin 500 mg + Ascorbic Acid (ARM B2)|PDI activity measured by DiESSG assay at 0 and 2 hours
11124432|NCT01722669|OG004|Outcome|Isoquercetin 1000 mg + Ascorbic Acid (ARM C)|PDI activity measured by DiESSG assay at 0 and 2 hours
11124433|NCT01722669|OG000|Outcome|Isoquercetin 1000 mg + Ascorbic Acid (ARM C)|Thrombin induced thrombin generation measured before and after isoquercetin + Ascorbic acid at time 0 and 4 hours
11124434|NCT01722669|OG001|Outcome|Antiphospholipid Antibody (ARM D)|Thrombin induced thrombin generation measured at time 0 and 4 hours following isoquercetin 1000 mg
11124435|NCT01722669|EG000|Reported Event|Quercetin 500 mg (ARM A1)|Toxicity over 24 hours following single dose
11124436|NCT01722669|EG001|Reported Event|Isoquercetin 500 mg (ARM B1)|Toxicity over 24 hours following single dose
11124437|NCT01722669|EG002|Reported Event|Quercetin 500 mg + Ascorbic Acid (ARM A2)|Toxicity over 24 hours following single dose of combined quercetin and ascorbic acid
11124438|NCT01722669|EG003|Reported Event|Isoquercetin 500 mg + Ascorbic Acid (ARM B2)|Toxicity over 24 hours following single dose of combined isoquercetin and ascorbic acid
11124439|NCT01722669|EG004|Reported Event|Isoquercetin 1000 mg + Ascorbic Acid (ARM C)|Toxicity over 24 hours following single dose of isoquercetin
11124440|NCT01722669|EG005|Reported Event|Antiphospholipid Antibody (ARM D)|Toxicity over 24 hours following single dose of isoquercetin
11124441|NCT01722734|BG000|Baseline|Control|Patients in this group received only a generic malaria information message (use bed nets) at the end of the study.
11124442|NCT01722734|BG001|Baseline|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
11124443|NCT01722734|BG002|Baseline|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
11124444|NCT01722734|BG003|Baseline|Total|Total of all reporting groups
11124445|NCT01722734|FG000|Participant Flow|Control|Control group participants received only a message after five days informing them about the importance of using bed nets for malaria. No reminders to take ACTs were sent.
11124446|NCT01722734|FG001|Participant Flow|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
11124447|NCT01722734|FG002|Participant Flow|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
11124448|NCT01722734|OG000|Outcome|Control|Subjects in this group received only one generic malaria message (use bed nets) at the end of the study.
11124449|NCT01722734|OG001|Outcome|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
11124450|NCT01722734|OG002|Outcome|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
11124451|NCT01722734|EG000|Reported Event|Control|Patients in this group received only a generic malaria message at the end of the study.
11124452|NCT01722734|EG001|Reported Event|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
11124453|NCT01722734|EG002|Reported Event|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
11124454|NCT01722877|BG000|Baseline|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery. Patients were eligible for the study only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5 ischemia, and at least one patent infrapopliteal runoff vessel. Patients were excluded if they were not able to give informed consent, had a creatinine level >2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure.The JetStream was used as a first modality of treatment, no other debulking devices, cutting/scoring balloons, or cryogenic balloons were allowed.
11124455|NCT01722877|FG000|Participant Flow|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
11124456|NCT01722877|OG000|Outcome|JetStream Atherectomy|"Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.~JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery."
11124457|NCT01722877|OG000|Outcome|JetStream Atherectomy|"Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.~25 patients in the Jetstream ISR study had a duplex Ultrasound to evaluate for patency of treated vessel at 6 months. Remaining patients did not have a DUS."
11124458|NCT01722877|OG000|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
11124459|NCT01722877|EG000|Reported Event|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
11124460|NCT01722994|BG000|Baseline|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
11124461|NCT01722994|BG001|Baseline|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
11124462|NCT01722994|BG002|Baseline|Total|Total of all reporting groups
11124463|NCT01722994|FG000|Participant Flow|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
11124464|NCT01722994|FG001|Participant Flow|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
11124465|NCT01722994|OG000|Outcome|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
11124466|NCT01722994|OG001|Outcome|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
11124467|NCT01722994|OG000|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
11124468|NCT01722994|OG001|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
11124469|NCT01722994|EG000|Reported Event|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
11124470|NCT01722994|EG001|Reported Event|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
11124471|NCT01723072|BG000|Baseline|Omalizumab|Omalizumab once a month via subcutaneous injection.
11124472|NCT01723072|BG001|Baseline|Placebo|Placebo of omalizumab once a month via subcutaneous injection
11124473|NCT01723072|BG002|Baseline|Total|Total of all reporting groups
11124474|NCT01723072|FG000|Participant Flow|Omalizumab|Omalizumab once a month via subcutaneous injection.
11124475|NCT01723072|FG001|Participant Flow|Placebo|Placebo of omalizumab once a month via subcutaneous injection
11124476|NCT01723072|OG000|Outcome|Omalizumab|Omalizumab once a month via subcutaneous injection.
11124477|NCT01723072|OG001|Outcome|Placebo|Placebo of omalizumab once a month via subcutaneous injection
11124478|NCT01723072|EG000|Reported Event|Omalizumab|Omalizumab once a month via subcutaneous injection.
11124479|NCT01723072|EG001|Reported Event|Placebo|Placebo of omalizumab once a month via subcutaneous injection
11124480|NCT01723163|BG000|Baseline|Intervention|"Abstinence Reinforcement Therapy (ART)~Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)"
11124481|NCT01723163|BG001|Baseline|Control|"Telephone Counseling~Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)"
11124482|NCT01723163|BG002|Baseline|Total|Total of all reporting groups
11124483|NCT01723163|FG000|Participant Flow|Intervention|"Abstinence Reinforcement Therapy (ART)~Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)"
11124484|NCT01723163|FG001|Participant Flow|Control|"Telephone Counseling~Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)"
11124485|NCT01723163|OG000|Outcome|Intervention|"Abstinence Reinforcement Therapy (ART)~Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)"
11124486|NCT01723163|OG001|Outcome|Control|"Telephone Counseling~Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)"
11124487|NCT01723163|EG000|Reported Event|Intervention|"Abstinence Reinforcement Therapy (ART)~Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)"
11124488|NCT01723163|EG001|Reported Event|Control|"Telephone Counseling~Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)"
11124489|NCT01723228|BG000|Baseline|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
11124490|NCT01723228|BG001|Baseline|Placebo|Placebo oral tablets once daily for 24 weeks
11124491|NCT01723228|BG002|Baseline|Total|Total of all reporting groups
11124492|NCT01723228|FG000|Participant Flow|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
11124493|NCT01723228|FG001|Participant Flow|Placebo|Placebo oral tablets once daily for 24 weeks
11124494|NCT01723228|OG000|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
11124495|NCT01723228|OG001|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
11124496|NCT01723228|EG000|Reported Event|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
11124497|NCT01723228|EG001|Reported Event|Placebo|Placebo oral tablets once daily for 24 weeks
11124498|NCT01723254|BG000|Baseline|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124499|NCT01723254|BG001|Baseline|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124500|NCT01723254|BG002|Baseline|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124501|NCT01723254|BG003|Baseline|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124502|NCT01723254|BG004|Baseline|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124503|NCT01723254|BG005|Baseline|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124504|NCT01723254|BG006|Baseline|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124505|NCT01723254|BG007|Baseline|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
11124506|NCT01723254|BG008|Baseline|Total|Total of all reporting groups
11124507|NCT01723254|FG000|Participant Flow|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124508|NCT01723254|FG001|Participant Flow|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124509|NCT01723254|FG002|Participant Flow|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124510|NCT01723254|FG003|Participant Flow|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124511|NCT01723254|FG004|Participant Flow|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124512|NCT01723254|FG005|Participant Flow|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124513|NCT01723254|FG006|Participant Flow|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124514|NCT01723254|FG007|Participant Flow|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
11124515|NCT01723254|OG000|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
11124516|NCT01723254|OG001|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
11124517|NCT01723254|OG002|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
11124518|NCT01723254|OG003|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
11124519|NCT01723254|OG004|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
11124520|NCT01723254|OG005|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
11124521|NCT01723254|OG006|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
11124522|NCT01723254|OG007|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
11124523|NCT01723254|EG000|Reported Event|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124524|NCT01723254|EG001|Reported Event|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124525|NCT01723254|EG002|Reported Event|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124526|NCT01723254|EG003|Reported Event|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124527|NCT01723254|EG004|Reported Event|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124528|NCT01723254|EG005|Reported Event|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124529|NCT01723254|EG006|Reported Event|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
11124530|NCT01723254|EG007|Reported Event|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
11124531|NCT01723384|BG000|Baseline|Naltrexone|"Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.~Intermittent Oral Naltrexone"
11124532|NCT01723384|BG001|Baseline|Placebo|"Intermittent oral placebo to be taken on an as-needed basis for 8 weeks~Placebo"
11124533|NCT01723384|BG002|Baseline|Total|Total of all reporting groups
11124534|NCT01723384|FG000|Participant Flow|Naltrexone|"Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.~Intermittent Oral Naltrexone"
11124535|NCT01723384|FG001|Participant Flow|Placebo|"Intermittent oral placebo to be taken on an as-needed basis for 8 weeks~Placebo"
11124536|NCT01723384|OG000|Outcome|Naltrexone|Naltrexone
11124537|NCT01723384|OG001|Outcome|Placebo|Placebo
11124538|NCT01723384|EG000|Reported Event|Naltrexone|Naltrexone
11124539|NCT01723384|EG001|Reported Event|Placebo|Placebo
11124540|NCT01723397|BG000|Baseline|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
11124541|NCT01723397|BG001|Baseline|Placebo Spray, Then Nasaleze Spray|"This group first received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
11124542|NCT01723397|BG002|Baseline|Total|Total of all reporting groups
11124543|NCT01723397|FG000|Participant Flow|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
11124544|NCT01723397|FG001|Participant Flow|Placebo Spray, Then Nasaleze Spray|"This group first received Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
11124545|NCT01723397|OG000|Outcome|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
11124546|NCT01723397|OG001|Outcome|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
11124547|NCT01723397|EG000|Reported Event|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
11124548|NCT01723397|EG001|Reported Event|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
11124549|NCT01723514|BG000|Baseline|Healthy: Placebo|Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
11124550|NCT01723514|BG001|Baseline|Healthy: Erenumab 21 mg|Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124551|NCT01723514|BG002|Baseline|Healthy: Erenumab 70 mg|Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124552|NCT01723514|BG003|Baseline|Healthy: Erenumab 140 mg|Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124553|NCT01723514|BG004|Baseline|Healthy: Erenumab 280/210 mg|Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
11124554|NCT01723514|BG005|Baseline|Migraine: Placebo|Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
11124555|NCT01723514|BG006|Baseline|Migraine: Erenumab 21 mg|Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124556|NCT01723514|BG007|Baseline|Migraine: Erenumab 140 mg|Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124557|NCT01723514|BG008|Baseline|Total|Total of all reporting groups
11124558|NCT01723514|FG000|Participant Flow|Healthy: Placebo|Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
11124559|NCT01723514|FG001|Participant Flow|Healthy: Erenumab 21 mg|Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124560|NCT01723514|FG002|Participant Flow|Healthy: Erenumab 70 mg|Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124561|NCT01723514|FG003|Participant Flow|Healthy: Erenumab 140 mg|Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124562|NCT01723514|FG004|Participant Flow|Healthy: Erenumab 280/210 mg|Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
11124563|NCT01723514|FG005|Participant Flow|Migraine: Placebo|Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
11124564|NCT01723514|FG006|Participant Flow|Migraine: Erenumab 21 mg|Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124565|NCT01723514|FG007|Participant Flow|Migraine: Erenumab 140 mg|Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124566|NCT01723514|OG000|Outcome|Healthy: Placebo|Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
11124567|NCT01723514|OG001|Outcome|Healthy: Erenumab 21 mg|Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124568|NCT01723514|OG002|Outcome|Healthy: Erenumab 70 mg|Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124569|NCT01723514|OG003|Outcome|Healthy: Erenumab 140 mg|Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124570|NCT01723514|OG004|Outcome|Healthy: Erenumab 280/210 mg|Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
11124571|NCT01723514|OG005|Outcome|Migraine: Placebo|Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
11124572|NCT01723514|OG006|Outcome|Migraine: Erenumab 21 mg|Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124573|NCT01723514|OG007|Outcome|Migraine: Erenumab 140 mg|Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124574|NCT01723514|EG000|Reported Event|Healthy: Placebo|Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
11124575|NCT01723514|EG001|Reported Event|Healthy: Erenumab 21 mg|Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124576|NCT01723514|EG002|Reported Event|Healthy: Erenumab 70 mg|Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124577|NCT01723514|EG003|Reported Event|Healthy: Erenumab 140 mg|Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124578|NCT01723514|EG004|Reported Event|Healthy: Erenumab 280/210 mg|Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
11124579|NCT01723514|EG005|Reported Event|Migraine: Placebo|Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
11124580|NCT01723514|EG006|Reported Event|Migraine: Erenumab 21 mg|Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124581|NCT01723514|EG007|Reported Event|Migraine: Erenumab 140 mg|Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
11124582|NCT01723696|BG000|Baseline|Placebo Tablet+Prenatal Vitamin|"A daily placebo tablet~Placebo tablet+prenatal vitamin"
11124583|NCT01723696|BG001|Baseline|Vitamin C +Prenatal Vitamin|Vitamin C +prenatal vitamin: Pregnant smoking women will be randomized to daily vitamin C (500 mg) versus daily placebo
11124584|NCT01723696|BG002|Baseline|Total|Total of all reporting groups
11124585|NCT01723696|FG000|Participant Flow|Placebo Tablet+Prenatal Vitamin|Participants in this arm were to take a daily placebo tablet+prenatal vitamin. Placebo tablets contained microcrystalline cellulose and 100 mg of citric acid to mimic the taste of Vitamin C.
11124586|NCT01723696|FG001|Participant Flow|Vitamin C +Prenatal Vitamin|Vitamin C +prenatal vitamin: Pregnant smoking women will be randomized to daily vitamin C (500 mg) versus daily placebo
11124587|NCT01723696|OG000|Outcome|Placebo Tablet+Prenatal Vitamin|"A daily placebo tablet~Placebo tablet+prenatal vitamin"
11124588|NCT01723696|OG001|Outcome|Vitamin C +Prenatal Vitamin|Vitamin C +prenatal vitamin: Pregnant smoking women will be randomized to daily vitamin C (500 mg) versus daily placebo
11124589|NCT01723696|EG000|Reported Event|Maternal/Fetal (Placebo)|"A daily placebo tablet~Placebo tablet+prenatal vitamin"
11124590|NCT01723696|EG001|Reported Event|Maternal/Fetal (Vitamin C)|Vitamin C +prenatal vitamin: Pregnant smoking women will be randomized to daily vitamin C (500 mg) versus daily placebo
11124591|NCT01723696|EG002|Reported Event|Infant (Placebo)|Infants of mothers in the Placebo group, who took a daily placebo + prenatal vitamin.
11124592|NCT01723696|EG003|Reported Event|Infant (Vitamin C)|Infants of mothers in the Vitamin C group, who took daily vitamin C (500 mg) and a prenatal vitamin
11124593|NCT01723722|BG000|Baseline|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
11124594|NCT01723722|BG001|Baseline|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
11124595|NCT01723722|BG002|Baseline|Total|Total of all reporting groups
11124596|NCT01723722|FG000|Participant Flow|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
11124597|NCT01723722|FG001|Participant Flow|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
11124598|NCT01723722|OG000|Outcome|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
11124599|NCT01723722|OG001|Outcome|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
11124600|NCT01723722|EG000|Reported Event|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
11124601|NCT01723722|EG001|Reported Event|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
11124602|NCT01723826|BG000|Baseline|PCP PL - OLE CREN SC - OLE CREN IV|Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
11124603|NCT01723826|BG001|Baseline|PCP PL - OLE CREN IV|Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
11124604|NCT01723826|BG002|Baseline|PCP CREN SC - OLE CREN SC - OLE CREN IV|Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
11124605|NCT01723826|BG003|Baseline|PCP CREN IV - OLE CREN IV|Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
11124606|NCT01723826|BG004|Baseline|Total|Total of all reporting groups
11124607|NCT01723826|FG000|Participant Flow|PCP PL - OLE CREN SC - OLE CREN IV|Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
11124608|NCT01723826|FG001|Participant Flow|PCP PL - OLE CREN IV|Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
11124609|NCT01723826|FG002|Participant Flow|PCP CREN SC - OLE CREN SC - OLE CREN IV|Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
11124610|NCT01723826|FG003|Participant Flow|PCP CREN IV - OLE CREN IV|Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
11124611|NCT01723826|OG000|Outcome|PCP PL - OLE CREN SC - OLE CREN IV|Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
11124612|NCT01723826|OG001|Outcome|PCP PL - OLE CREN IV|Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
11124613|NCT01723826|OG002|Outcome|PCP CREN - OLE CREN SC -OLE CREN IV|Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
11124614|NCT01723826|OG003|Outcome|PCP CREN - OLE CREN IV|Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
11124615|NCT01723826|EG000|Reported Event|PCP PL - OLE CREN SC - OLE CREN IV|Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
11124616|NCT01723826|EG001|Reported Event|PCP PL - OLE CREN IV|Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
11124617|NCT01723826|EG002|Reported Event|PCP CREN SC - OLE CREN SC - OLE CREN IV|Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
11124618|NCT01723826|EG003|Reported Event|PCP CREN IV - OLE CREN IV|Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
11124619|NCT01723904|BG000|Baseline|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
11124620|NCT01723904|FG000|Participant Flow|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
11124621|NCT01723904|OG000|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
11124622|NCT01723904|EG000|Reported Event|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
11124623|NCT01724021|BG000|Baseline|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124624|NCT01724021|BG001|Baseline|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124625|NCT01724021|BG002|Baseline|Total|Total of all reporting groups
11124626|NCT01724021|FG000|Participant Flow|Arm A|Participants in Arm A received one cycle of rituximab 375 milligram per metre square (mg/m^2) intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124627|NCT01724021|FG001|Participant Flow|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124628|NCT01724021|OG000|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124629|NCT01724021|OG001|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124630|NCT01724021|OG000|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124631|NCT01724021|OG001|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124632|NCT01724021|EG000|Reported Event|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124633|NCT01724021|EG001|Reported Event|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
11124634|NCT01724060|BG000|Baseline|Gastric Bypass|Patients due for gastric bypass surgery
11124635|NCT01724060|BG001|Baseline|Gastric Banding|Patients due for gastric banding
11124636|NCT01724060|BG002|Baseline|Sleeve Gastrectomy|Patients due for sleeve gastrectomy
11124637|NCT01724060|BG003|Baseline|Endobarrier|Patients due to undergo endoscopic Endobarrier insertion
11124638|NCT01724060|BG004|Baseline|Exenatide|Patients due to be commenced on Exenatide
11124639|NCT01724060|BG005|Baseline|Liraglutide|Patients due to be commenced on Liraglutide
11124640|NCT01724060|BG006|Baseline|Lifestyle|Patients due to be commenced on a lifestyle intervention programme
11124641|NCT01724060|BG007|Baseline|Elective Surgery or Endoscopy|Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy
11124642|NCT01724060|BG008|Baseline|Total|Total of all reporting groups
11124643|NCT01724060|FG000|Participant Flow|Gastric Bypass|Patients due for gastric bypass surgery
11124644|NCT01724060|FG001|Participant Flow|Gastric Banding|Patients due for gastric banding
11124645|NCT01724060|FG002|Participant Flow|Sleeve Gastrectomy|Patients due for sleeve gastrectomy
11124646|NCT01724060|FG003|Participant Flow|Endobarrier|Patients due to undergo endoscopic Endobarrier insertion
11124647|NCT01724060|FG004|Participant Flow|Exenatide|Patients due to be commenced on Exenatide
11124648|NCT01724060|FG005|Participant Flow|Liraglutide|Patients due to be commenced on Liraglutide
11124649|NCT01724060|FG006|Participant Flow|Lifestyle|Patients due to be commenced on a lifestyle intervention programme
11124650|NCT01724060|FG007|Participant Flow|Elective Surgery or Endoscopy|Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy
11124651|NCT01724060|OG000|Outcome|Gastric Bypass|Patients due for gastric bypass surgery
11124652|NCT01724060|OG001|Outcome|Gastric Banding|Patients due for gastric banding
11124653|NCT01724060|OG002|Outcome|Sleeve Gastrectomy|Patients due for sleeve gastrectomy
11124654|NCT01724060|OG003|Outcome|Endobarrier|Patients due to undergo endoscopic Endobarrier insertion
11124655|NCT01724060|OG004|Outcome|Exenatide|Patients due to be commenced on Exenatide
11124656|NCT01724060|OG005|Outcome|Liraglutide|Patients due to be commenced on Liraglutide
11124657|NCT01724060|OG006|Outcome|Lifestyle|Patients due to be commenced on a lifestyle intervention programme
11124658|NCT01724060|OG007|Outcome|Elective Surgery or Endoscopy|Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy
11124659|NCT01724060|EG000|Reported Event|Gastric Bypass|Patients due for gastric bypass surgery.
11124660|NCT01724060|EG001|Reported Event|Gastric Banding|Patients due for gastric banding.
11124661|NCT01724060|EG002|Reported Event|Sleeve Gastrectomy|Patients due for sleeve gastrectomy.
11124662|NCT01724060|EG003|Reported Event|EndoBarrier|Patients due to undergo endoscopic Endobarrier insertion.
11124663|NCT01724060|EG004|Reported Event|Exenatide|Patients due to be commenced on Exenatide.
11124664|NCT01724060|EG005|Reported Event|Liraglutide|Patients due to be commenced on Liraglutide.
11124665|NCT01724060|EG006|Reported Event|Lifestyle|Patients due to be commenced on a lifestyle intervention programme.
11124666|NCT01724060|EG007|Reported Event|Elective Surgery or Endoscopy|Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy. No adverse events recorded.
11124667|NCT01724177|BG000|Baseline|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
11124668|NCT01724177|FG000|Participant Flow|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
11124669|NCT01724177|OG000|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
11124670|NCT01724177|OG000|Outcome|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
11124671|NCT01724177|EG000|Reported Event|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
11124672|NCT01724216|BG000|Baseline|Single Arm|Magnetic Resonance Image Collection Using Innovative Pulse Sequences
11124673|NCT01724216|FG000|Participant Flow|Single Arm|Magnetic Resonance Images Collected Using Innovative Pulse Sequences :
11124674|NCT01724216|OG000|Outcome|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
11006491|NCT01086150|EG002|Reported Event|Patients With Non-painful Diabetic Peripheral Neuropathy|"18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.~Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.~Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove."
11006492|NCT01086215|BG000|Baseline|Limb Ischemia|Patients presenting with limb ischemia for treatment
11006493|NCT01086215|BG001|Baseline|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
11006494|NCT01086215|BG002|Baseline|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
11006495|NCT01086215|BG003|Baseline|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
11006496|NCT01086215|BG004|Baseline|Total|Total of all reporting groups
11006497|NCT01086215|FG000|Participant Flow|Limb Ischemia|Patients presenting with limb ischemia for treatment
11006498|NCT01086215|FG001|Participant Flow|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
11006499|NCT01086215|FG002|Participant Flow|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
11124675|NCT01724216|EG000|Reported Event|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
11124676|NCT01724359|BG000|Baseline|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
11006500|NCT01086215|FG003|Participant Flow|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
11006501|NCT01086215|OG000|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
11006502|NCT01086215|OG001|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
11006503|NCT01086215|OG002|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
11006504|NCT01086215|OG003|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
11006505|NCT01086215|EG000|Reported Event|Limb Ischemia|Patients presenting with limb ischemia for treatment
11006506|NCT01086215|EG001|Reported Event|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
11006507|NCT01086215|EG002|Reported Event|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
11006508|NCT01086215|EG003|Reported Event|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
11006509|NCT01086228|BG000|Baseline|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
11006510|NCT01086228|FG000|Participant Flow|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
11006511|NCT01086228|OG000|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
11006512|NCT01086228|EG000|Reported Event|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
11006513|NCT01086358|BG000|Baseline|All Completed Study Participants|"Participants received their usual prescribed triptan or Treximet, depending on the randomization schedule.~Usual prescribed triptan: usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan"
11006514|NCT01086358|FG000|Participant Flow|Usual Prescribed Triptan First|Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 60, with 30 in each sequence, would power the study at 86%.
11006515|NCT01086358|FG001|Participant Flow|Treximet Arm First|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%."
11006516|NCT01086358|OG000|Outcome|Arm 1 - Triptan|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan"
11006517|NCT01086358|OG001|Outcome|Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg"
11006518|NCT01086358|EG000|Reported Event|Usual Prescribed Triptan|Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.
11124677|NCT01724359|FG000|Participant Flow|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
11124678|NCT01724359|OG000|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
11124679|NCT01724359|OG000|Outcome|Patients at Baseline: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
11124680|NCT01724359|OG001|Outcome|Patients at Week 26: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
11124681|NCT01724359|EG000|Reported Event|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
11124682|NCT01724489|BG000|Baseline|Growth Hormone|"Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.~Growth hormone"
11124683|NCT01724489|BG001|Baseline|Placebo|"Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.~Placebo"
11124684|NCT01724489|BG002|Baseline|Total|Total of all reporting groups
11124685|NCT01724489|FG000|Participant Flow|Growth Hormone|Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered up to 18 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.
11124686|NCT01724489|FG001|Participant Flow|Placebo|Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self administered sub-cutaneous daily for 18 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
11124687|NCT01724489|OG000|Outcome|Growth Hormone|Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered up to 18 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.
11124688|NCT01724489|OG001|Outcome|Placebo|Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self administered sub-cutaneous daily for 18 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
11124689|NCT01724489|EG000|Reported Event|Growth Hormone|"Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.~Growth hormone"
11124690|NCT01724489|EG001|Reported Event|Placebo|"Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.~Placebo"
11124691|NCT01724528|BG000|Baseline|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
11124692|NCT01724528|BG001|Baseline|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
11124693|NCT01724528|BG002|Baseline|Total|Total of all reporting groups
11124694|NCT01724528|FG000|Participant Flow|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
11124695|NCT01724528|FG001|Participant Flow|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
11124696|NCT01724528|OG000|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
11124697|NCT01724528|OG001|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
11124698|NCT01724528|EG000|Reported Event|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
11124699|NCT01724528|EG001|Reported Event|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
11124700|NCT01725126|BG000|Baseline|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
11224523|NCT02360488|FG000|Participant Flow|Telerehabilitation Therapy|"The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.~Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions."
11124701|NCT01725126|BG001|Baseline|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
11124702|NCT01725126|BG002|Baseline|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 milligram (mg) once daily by subcutaneous injection during the Treatment period along with placebo.
11124703|NCT01725126|BG003|Baseline|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
11124704|NCT01725126|BG004|Baseline|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
11124705|NCT01725126|BG005|Baseline|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
11124706|NCT01725126|BG006|Baseline|Total|Total of all reporting groups
11124707|NCT01725126|FG000|Participant Flow|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 gram (g) kit twice daily (BID) for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 milliliter (mL) of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 milligram (mg) immediate release (IR) tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
11124708|NCT01725126|FG001|Participant Flow|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
11124709|NCT01725126|FG002|Participant Flow|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 milligram (mg) once daily by subcutaneous injection during the Treatment period along with placebo.
11336351|NCT03565315|FG003|Participant Flow|Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11124710|NCT01725126|FG003|Participant Flow|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
11124711|NCT01725126|FG004|Participant Flow|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
11124712|NCT01725126|FG005|Participant Flow|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
11124713|NCT01725126|OG000|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
11124714|NCT01725126|OG001|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
11124715|NCT01725126|OG000|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 milligram (mg) once daily by subcutaneous injection during the Treatment period along with placebo.
11124716|NCT01725126|OG001|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
11124717|NCT01725126|OG002|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
11336352|NCT03565315|OG000|Outcome|Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group|"10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1."
10846083|NCT00272961|OG001|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
11124718|NCT01725126|OG003|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
11124719|NCT01725126|OG000|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
11124720|NCT01725126|OG003|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15g to 40g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
11124721|NCT01725126|OG002|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo as once daily or BID.
11124722|NCT01725126|OG003|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
11124723|NCT01725126|OG000|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg immediate release (IR) tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
11124724|NCT01725126|OG000|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
11124725|NCT01725126|OG001|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
10846084|NCT00272961|OG002|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
10848776|NCT00291447|EG000|Reported Event|Cohort 1|"Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11124726|NCT01725126|OG003|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 1 5g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
11124727|NCT01725126|OG000|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
11124728|NCT01725126|EG000|Reported Event|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID or 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
11124729|NCT01725126|EG001|Reported Event|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
11124730|NCT01725126|EG002|Reported Event|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
11124731|NCT01725126|EG003|Reported Event|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
11124732|NCT01725126|EG004|Reported Event|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
11124733|NCT01725126|EG005|Reported Event|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
11124734|NCT01725217|BG000|Baseline|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
11124735|NCT01725217|BG001|Baseline|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
11124736|NCT01725217|BG002|Baseline|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
11124737|NCT01725217|BG003|Baseline|Total|Total of all reporting groups
11124738|NCT01725217|FG000|Participant Flow|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
11124739|NCT01725217|FG001|Participant Flow|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
11124740|NCT01725217|FG002|Participant Flow|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
11124741|NCT01725217|OG000|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
11124742|NCT01725217|OG000|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
11124743|NCT01725217|OG001|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
11124744|NCT01725217|OG002|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
11124745|NCT01725217|OG001|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
11124746|NCT01725217|OG002|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
11124747|NCT01725217|OG003|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
11124748|NCT01725217|OG000|Outcome|≥2 to ≤5 Years|Subjects ≥2 to ≤5 years of age who received one vaccination of MenACWY-CRM
11124749|NCT01725217|OG001|Outcome|≥2 to ≤3 Years|Subjects ≥2 to ≤3 years of age who received one vaccination of MenACWY-CRM
11124750|NCT01725217|OG000|Outcome|Overall (≥6 Years)|All subjects ≥6 years of age who received one vaccination of MenACWY-CRM
11124751|NCT01725217|OG001|Outcome|≥6 to ≤10 Years|Subjects ≥6 to ≤10 years of age who received one vaccination of MenACWY-CRM
11124752|NCT01725217|EG000|Reported Event|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
11124753|NCT01725217|EG001|Reported Event|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
11124754|NCT01725217|EG002|Reported Event|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
11124755|NCT01725217|EG003|Reported Event|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
11124756|NCT01725282|BG000|Baseline|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
11124757|NCT01725282|BG001|Baseline|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
11124758|NCT01725282|BG002|Baseline|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
11124759|NCT01725282|BG003|Baseline|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
11124760|NCT01725282|BG004|Baseline|Total|Total of all reporting groups
11124761|NCT01725282|FG000|Participant Flow|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
11124762|NCT01725282|FG001|Participant Flow|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
11124763|NCT01725282|FG002|Participant Flow|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
11124764|NCT01725282|FG003|Participant Flow|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
11124765|NCT01725282|OG000|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
11124766|NCT01725282|OG001|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
11124767|NCT01725282|OG002|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
11124768|NCT01725282|OG003|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
11124769|NCT01725282|EG000|Reported Event|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
11124770|NCT01725282|EG001|Reported Event|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
11124771|NCT01725282|EG002|Reported Event|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
11124772|NCT01725282|EG003|Reported Event|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
11124773|NCT01725308|BG000|Baseline|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
11124774|NCT01725308|BG001|Baseline|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
11124775|NCT01725308|BG002|Baseline|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
11124776|NCT01725308|BG003|Baseline|Total|Total of all reporting groups
11006519|NCT01086358|EG001|Reported Event|Treximet Arm|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%."
11006520|NCT01086384|BG000|Baseline|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11006521|NCT01086384|BG001|Baseline|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11006522|NCT01086384|BG002|Baseline|Total|Total of all reporting groups
11006523|NCT01086384|FG000|Participant Flow|FP 250 µg/ICS|Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
11006524|NCT01086384|FG001|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11006525|NCT01086384|FG002|Participant Flow|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11006526|NCT01086384|OG000|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11006527|NCT01086384|OG001|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11006528|NCT01086384|EG000|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11006529|NCT01086384|EG001|Reported Event|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11006530|NCT01086410|BG000|Baseline|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
11006531|NCT01086410|BG001|Baseline|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
11006532|NCT01086410|BG002|Baseline|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
11006533|NCT01086410|BG003|Baseline|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
11006534|NCT01086410|BG004|Baseline|Total|Total of all reporting groups
11006535|NCT01086410|FG000|Participant Flow|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
11006536|NCT01086410|FG001|Participant Flow|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
11006537|NCT01086410|FG002|Participant Flow|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
11124777|NCT01725308|FG000|Participant Flow|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124778|NCT01725308|FG001|Participant Flow|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124779|NCT01725308|FG002|Participant Flow|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124780|NCT01725308|OG000|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
11124781|NCT01725308|OG001|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
11124782|NCT01725308|OG002|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
11124783|NCT01725308|OG000|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124784|NCT01725308|OG001|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124785|NCT01725308|OG002|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124786|NCT01725308|OG002|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
11124787|NCT01725308|EG000|Reported Event|Treatment Period I: Placebo|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124788|NCT01725308|EG001|Reported Event|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124789|NCT01725308|EG002|Reported Event|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124790|NCT01725308|EG003|Reported Event|Treatment Period I + II: Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124791|NCT01725308|EG004|Reported Event|Treatment Period I + II: FK949E 150 mg / FK949E|Participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124792|NCT01725308|EG005|Reported Event|Treatment Period I + II: FK949E 300 mg / FK949E|Participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
11124793|NCT01725386|BG000|Baseline|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
11124794|NCT01725386|BG001|Baseline|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
11124795|NCT01725386|BG002|Baseline|Total|Total of all reporting groups
11124796|NCT01725386|FG000|Participant Flow|Monotherapy|Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice.
11124797|NCT01725386|FG001|Participant Flow|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
11124798|NCT01725386|OG000|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
11124799|NCT01725386|OG001|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
11124800|NCT01725386|EG000|Reported Event|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
11124801|NCT01725386|EG001|Reported Event|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
11124802|NCT01725451|BG000|Baseline|Testosterone 2% Solution|Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
11124803|NCT01725451|FG000|Participant Flow|Sequence 1|30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
11124804|NCT01725451|FG001|Participant Flow|Sequence 2|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
11124805|NCT01725451|FG002|Participant Flow|Sequence 3|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
11336353|NCT03565315|OG001|Outcome|Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1."
11124806|NCT01725451|FG003|Participant Flow|Sequence 4|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
11124807|NCT01725451|OG000|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
11124808|NCT01725451|OG001|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
11124809|NCT01725451|OG002|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
11124810|NCT01725451|OG003|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
11124811|NCT01725451|OG004|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
11124812|NCT01725451|OG005|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
11124813|NCT01725451|OG002|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution .
11124814|NCT01725451|EG000|Reported Event|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
11124815|NCT01725451|EG001|Reported Event|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
11124816|NCT01725451|EG002|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
11124817|NCT01725451|EG003|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
11124818|NCT01725451|EG004|Reported Event|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
11124819|NCT01725451|EG005|Reported Event|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
11124820|NCT01725529|BG000|Baseline|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
11124821|NCT01725529|BG001|Baseline|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
11124822|NCT01725529|BG002|Baseline|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
11124823|NCT01725529|BG003|Baseline|Total|Total of all reporting groups
11124824|NCT01725529|FG000|Participant Flow|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
11124825|NCT01725529|FG001|Participant Flow|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
11124826|NCT01725529|FG002|Participant Flow|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
11124827|NCT01725529|OG000|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
11124828|NCT01725529|OG001|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
11124829|NCT01725529|OG002|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
11124830|NCT01725529|EG000|Reported Event|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
11124831|NCT01725529|EG001|Reported Event|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
11124832|NCT01725529|EG002|Reported Event|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
11124833|NCT01725750|BG000|Baseline|Bright White Light (BWL)|"Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6 x 5 x 1) and lightweight (8 oz.) box."
11124834|NCT01725750|BG001|Baseline|Dim Red Light (DRL)|Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
11124835|NCT01725750|BG002|Baseline|Total|Total of all reporting groups
11124836|NCT01725750|FG000|Participant Flow|Bright White Light (BWL)|"Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6 x 5 x 1) and lightweight (8 oz.) box."
11124837|NCT01725750|FG001|Participant Flow|Dim Red Light (DRL)|Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
11124838|NCT01725750|OG000|Outcome|Bright White Light (BWL)|"Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6 x 5 x 1) and lightweight (8 oz.) box."
11124839|NCT01725750|OG001|Outcome|Dim Red Light (DRL)|Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
11124840|NCT01725750|OG000|Outcome|Bright White Light (BWL)|"Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6 x 5 x 1) and lightweight (8 oz.) box.~Bright White Light (BWL): Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18 from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box."
11124841|NCT01725750|OG001|Outcome|Dim Red Light (DRL)|"Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.~Dim Red Light (DRL): A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18 from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box."
11124842|NCT01725750|EG000|Reported Event|Bright White Light (BWL)|"Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6 x 5 x 1) and lightweight (8 oz.) box."
11124843|NCT01725750|EG001|Reported Event|Dim Red Light (DRL)|Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
11124844|NCT01725815|BG000|Baseline|HARP Intervention|HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.
11124845|NCT01725815|BG001|Baseline|No Intervention: Control|Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
11124846|NCT01725815|BG002|Baseline|Total|Total of all reporting groups
11124847|NCT01725815|FG000|Participant Flow|HARP Intervention|HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.
11124848|NCT01725815|FG001|Participant Flow|No Intervention: Control|Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
11124849|NCT01725815|OG000|Outcome|HARP Intervention|HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.
11124850|NCT01725815|OG001|Outcome|No Intervention: Control|Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
11124851|NCT01725815|EG000|Reported Event|HARP Intervention|HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.
11124852|NCT01725815|EG001|Reported Event|No Intervention: Control|Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
11124853|NCT01725984|BG000|Baseline|AdVance|Subjects previously implanted with the AdVance Male Sling
11124854|NCT01725984|BG001|Baseline|AdVance XP|Subjects previously implanted with the AdVance XP male sling
11124855|NCT01725984|BG002|Baseline|Total|Total of all reporting groups
11124856|NCT01725984|FG000|Participant Flow|AdVance|Subjects previously implanted with the AdVance Male Sling
11124857|NCT01725984|FG001|Participant Flow|AdVance XP|Subjects previously implanted with the AdVance XP male sling
11124858|NCT01725984|OG000|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
11124859|NCT01725984|OG001|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
11124860|NCT01725984|EG000|Reported Event|AdVance|Subjects implanted with the AdVance Male Sling
11124861|NCT01725984|EG001|Reported Event|AdVance XP|Subjects implanted with the AdVance XP Male Sling
11124862|NCT01726023|BG000|Baseline|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
11124863|NCT01726023|BG001|Baseline|Meropenem|Meropenem powder for solution for infusion 1000mg
11124864|NCT01726023|BG002|Baseline|Total|Total of all reporting groups
11124865|NCT01726023|FG000|Participant Flow|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
11124866|NCT01726023|FG001|Participant Flow|Meropenem|Meropenem powder for solution for infusion 1000mg
11124867|NCT01726023|OG000|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
11124868|NCT01726023|OG001|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
11124869|NCT01726023|OG000|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
11124870|NCT01726023|OG000|Outcome|Ceftazidime(1)|15 minutes before or after
11124871|NCT01726023|OG001|Outcome|Avibactam(1)|15 minutes before or after
11124872|NCT01726023|OG002|Outcome|Ceftazidime(2)|30-90 minutes after
11124873|NCT01726023|OG003|Outcome|Avibactam(2)|30-90 minutes after
11124874|NCT01726023|OG004|Outcome|Ceftazidime(3)|300-360 minutes after
11124875|NCT01726023|OG005|Outcome|Avibactam(3)|300-360 minutes after
11124876|NCT01726023|EG000|Reported Event|CAZ-AVI Plus Metronidazole|
11124877|NCT01726023|EG001|Reported Event|Meropenem|Meropenem powder for solution for infusion 1000mg
11124878|NCT01726036|BG000|Baseline|Gomco Circumcision Clamp|"Gomco circumcision clamp used for neonatal circumcision.~Gomco Circumcision Clamp"
11124879|NCT01726036|BG001|Baseline|Mogen Circumcision Clamp|"Mogen circumcision clamp used for neonatal circumcision.~Mogen Circumcision Clamp"
11124880|NCT01726036|BG002|Baseline|Total|Total of all reporting groups
11124881|NCT01726036|FG000|Participant Flow|Gomco Circumcision Clamp|"Gomco circumcision clamp used for neonatal circumcision.~Gomco Circumcision Clamp"
11124882|NCT01726036|FG001|Participant Flow|Mogen Circumcision Clamp|"Mogen circumcision clamp used for neonatal circumcision.~Mogen Circumcision Clamp"
11124883|NCT01726036|OG000|Outcome|Gomco Circumcision Clamp|"Gomco circumcision clamp used for neonatal circumcision.~Gomco Circumcision Clamp"
11124884|NCT01726036|OG001|Outcome|Mogen Circumcision Clamp|"Mogen circumcision clamp used for neonatal circumcision.~Mogen Circumcision Clamp"
11124885|NCT01726036|EG000|Reported Event|Gomco Circumcision Clamp|"Gomco circumcision clamp used for neonatal circumcision.~Gomco Circumcision Clamp"
11124886|NCT01726036|EG001|Reported Event|Mogen Circumcision Clamp|"Mogen circumcision clamp used for neonatal circumcision.~Mogen Circumcision Clamp"
11124887|NCT01726049|BG000|Baseline|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
11124888|NCT01726049|BG001|Baseline|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
11124889|NCT01726049|BG002|Baseline|Total|Total of all reporting groups
11124890|NCT01726049|FG000|Participant Flow|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
11124891|NCT01726049|FG001|Participant Flow|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
11124892|NCT01726049|OG000|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
11124893|NCT01726049|OG001|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
11124894|NCT01726049|EG000|Reported Event|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
11124895|NCT01726049|EG001|Reported Event|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
11124896|NCT01726270|BG000|Baseline|All Subjects|"Part 1 included subjects who answer the self-selection question, probing question and follow-up questions.~Part 2 included subjects who self-selected to use the product, purchase the product and took at least one dose of drug and participate in at least 1 phone interview."
11124897|NCT01726270|FG000|Participant Flow|All Subjects|"Part 1 included subjects who answer the self-selection question, probing question and follow-up questions.~Part 2 included subjects who self-selected to use the product, purchase the product and took at least one dose of drug and participate in at least 1 phone interview."
11124898|NCT01726270|OG000|Outcome|Tamsulosin Hydrochloride|Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
11124899|NCT01726270|EG000|Reported Event|EVAL-SS|Evaluable Analysis Set for Self-Selection (EVAL-SS): The EVAL-SS included all subjects who answered the self-selection question, probing question and follow-up questions (Part 1).
11124900|NCT01726270|EG001|Reported Event|Treated Set|Treated Set (TS): The TS included all subjects who self-selected to use the product, purchased the product, and then took at least one dose of drug (Part 2).
11124901|NCT01726270|EG002|Reported Event|FAS-AUS|Full Analysis Set for Actual Use Decision (FAS-AUS): The FAS-AUS included all subjects who self-selected to use the product, purchased the product, took at least one dose of drug and participated in at least 1 phone interview (Part 2).
11124902|NCT01726335|BG000|Baseline|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
11124903|NCT01726335|FG000|Participant Flow|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
11124904|NCT01726335|OG000|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
11124905|NCT01726335|EG000|Reported Event|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
11124906|NCT01726504|BG000|Baseline|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.~The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.~Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
11124907|NCT01726504|BG001|Baseline|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
11124908|NCT01726504|BG002|Baseline|Total|Total of all reporting groups
11124909|NCT01726504|FG000|Participant Flow|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.~The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.~Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
11124910|NCT01726504|FG001|Participant Flow|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
11124911|NCT01726504|OG000|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
11126869|NCT01736124|EG000|Reported Event|Computerized Cognitive Training (CCT)|Randomly selected subjects perform adaptive computerized cognitive training (CCT) program, CognifitTM], involving a variety of computer games tailored to address their personal cognitive deficits. Cognifit is a web-accessed CCT program designed to improve cognition by targeting the user's weaker cognitive functions. The challenge at each session was adapted according to the user's prior performance and a cognitive score pertaining to the specific session was provided. Participants were instructed to have sessions three times per week for eight weeks, with at least one day of rest between sessions, for a total of 24 sessions. Each 20 minute session included a unique combination of three games accessing a variety of cognitive abilities.
11124912|NCT01726504|OG001|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
11124913|NCT01726504|EG000|Reported Event|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
11124914|NCT01726504|EG001|Reported Event|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
11124915|NCT01726517|BG000|Baseline|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
11124916|NCT01726517|BG001|Baseline|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
11124917|NCT01726517|BG002|Baseline|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
11124918|NCT01726517|BG003|Baseline|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
11124919|NCT01726517|BG004|Baseline|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
11124920|NCT01726517|BG005|Baseline|Total|Total of all reporting groups
11124921|NCT01726517|FG000|Participant Flow|LDV/SOF 8 Weeks (TN)|Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks.
11124922|NCT01726517|FG001|Participant Flow|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks.
11124923|NCT01726517|FG002|Participant Flow|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
11124924|NCT01726517|FG003|Participant Flow|LDV/SOF 12 Weeks (TE)|Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
11124925|NCT01726517|FG004|Participant Flow|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
11124926|NCT01726517|OG000|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
11124927|NCT01726517|OG001|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
11124928|NCT01726517|OG002|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
11124929|NCT01726517|OG003|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
11124930|NCT01726517|OG004|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
11124931|NCT01726517|EG000|Reported Event|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
11124932|NCT01726517|EG001|Reported Event|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
11124933|NCT01726517|EG002|Reported Event|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
11124934|NCT01726517|EG003|Reported Event|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
11124935|NCT01726517|EG004|Reported Event|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
11124936|NCT01726621|BG000|Baseline|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
11006538|NCT01086410|FG003|Participant Flow|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
11006539|NCT01086410|OG000|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
11006540|NCT01086410|OG001|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
11006541|NCT01086410|OG002|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
11006542|NCT01086410|OG003|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
11006543|NCT01086410|EG000|Reported Event|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
11006544|NCT01086410|EG001|Reported Event|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
11006545|NCT01086410|EG002|Reported Event|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
11006546|NCT01086410|EG003|Reported Event|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
11006547|NCT01086423|BG000|Baseline|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
11006548|NCT01086423|BG001|Baseline|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
11006549|NCT01086423|BG002|Baseline|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
11006550|NCT01086423|BG003|Baseline|Total|Total of all reporting groups
11006551|NCT01086423|FG000|Participant Flow|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
11006552|NCT01086423|FG001|Participant Flow|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
11006553|NCT01086423|FG002|Participant Flow|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
11006554|NCT01086423|OG000|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
11006555|NCT01086423|OG001|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
11006556|NCT01086423|OG002|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
11006557|NCT01086423|EG000|Reported Event|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
11124937|NCT01726621|FG000|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
11124938|NCT01726621|OG000|Outcome|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
11124939|NCT01726621|EG000|Reported Event|Insulin Dependent Diabetics|"Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter~Medtronic MiniMed 620G or 640G Insulin Pump: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks."
11124940|NCT01726673|BG000|Baseline|tDCS + Robotic Arm Therapy|"Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)~Transcranial Direct Current Stimulation (tDCS)"
11124941|NCT01726673|BG001|Baseline|tDCS Sham + Robotic Arm Therapy|"Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)~Placebo sham"
11124942|NCT01726673|BG002|Baseline|Total|Total of all reporting groups
11124943|NCT01726673|FG000|Participant Flow|tDCS + Robotic Arm Therapy|"Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)~Transcranial Direct Current Stimulation (tDCS)"
11124944|NCT01726673|FG001|Participant Flow|tDCS Sham + Robotic Arm Therapy|"Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).~Placebo sham"
11124945|NCT01726673|OG000|Outcome|tDCS + Robotic Arm Therapy|"Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)~Transcranial Direct Current Stimulation (tDCS)"
11124946|NCT01726673|OG001|Outcome|tDCS Sham + Robotic Arm Therapy|"Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).~Placebo sham"
11124947|NCT01726673|EG000|Reported Event|tDCS + Robotic Arm Therapy|"Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)~Transcranial Direct Current Stimulation (tDCS)"
11124948|NCT01726673|EG001|Reported Event|tDCS Sham + Robotic Arm Therapy|"Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).~Placebo sham"
11124949|NCT01726738|BG000|Baseline|BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors|BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
11124950|NCT01726738|FG000|Participant Flow|BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors|BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the Recommend Phase 2 Dose (RP2D) determined in the Phase I/II study (BRF113220): trametinib 2mg once a day (QD) and dabrafenib 150 mg twice a day (BID) on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
10846085|NCT00272961|OG003|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
11124951|NCT01726738|OG000|Outcome|BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors|BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
11124952|NCT01726738|EG000|Reported Event|BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors|BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
11124953|NCT01726803|BG000|Baseline|Usual Care|Usual Care: The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress.
11124954|NCT01726803|BG001|Baseline|Early Physical Therapy With Usual Care|The Early Physical Therapy arm will receive the same advice and education intervention received by the usual care group and will be referred to receive 4 sessions of physical therapy during the first 4 weeks. The physical therapy protocol involves spinal manipulation and exercise.
11124955|NCT01726803|BG002|Baseline|Total|Total of all reporting groups
10878774|NCT00454207|FG000|Participant Flow|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
11006558|NCT01086423|EG001|Reported Event|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
11006559|NCT01086423|EG002|Reported Event|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
11006560|NCT01086475|BG000|Baseline|D-cycloserine|"Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions~D-cycloserine: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions"
11006561|NCT01086475|BG001|Baseline|Placebo|"Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions~Placebo: Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions"
11006562|NCT01086475|BG002|Baseline|Total|Total of all reporting groups
11006563|NCT01086475|FG000|Participant Flow|D-cycloserine|Subjects who received d-cycloserine
11006564|NCT01086475|FG001|Participant Flow|Placebo|Subjects who received placebo
11006565|NCT01086475|OG000|Outcome|D-cycloserine|Subjects who received d-cycloserine
11006566|NCT01086475|OG001|Outcome|Placebo|Subjects who received placebo
11006567|NCT01086475|EG000|Reported Event|D-cycloserine|Subjects who received d-cycloserine
11006568|NCT01086475|EG001|Reported Event|Placebo|Subjects who received placebo
11006569|NCT01086540|BG000|Baseline|Rituximab|Rituximab (a monoclonal antibody to CD20) was administered as two IV infusions, 1000 mg each, given two weeks apart at Day 0 and Week 2. Participants were pre-treated with corticosteroids, diphenhydramine, and acetaminophen. The appearance of the packaging and solutions used to administer rituximab/placebo was identical in both study arms.
11006570|NCT01086540|BG001|Baseline|Placebo|Placebo was administered as two IV infusions, given two weeks apart at Day 0 and Week 2. Participants were pre-treated with corticosteroids, diphenhydramine, and acetaminophen. The appearance of the packaging and solutions used to administer rituximab/placebo was identical in both study arms.
11006571|NCT01086540|BG002|Baseline|Total|Total of all reporting groups
11006572|NCT01086540|FG000|Participant Flow|Rituximab|Rituximab (a monoclonal antibody to CD20) was administered as two IV infusions, 1000 mg each, given two weeks apart at Day 0 and Week 2. Participants were pre-treated with corticosteroids, diphenhydramine, and acetaminophen. The appearance of the packaging and solutions used to administer rituximab/placebo was identical in both study arms.
11006573|NCT01086540|FG001|Participant Flow|Placebo|Placebo was administered as two IV infusions, given two weeks apart at Day 0 and Week 2. Participants were pre-treated with corticosteroids, diphenhydramine, and acetaminophen. The appearance of the packaging and solutions used to administer rituximab/placebo was identical in both study arms.
11006574|NCT01086540|OG000|Outcome|Rituximab|Rituximab (a monoclonal antibody to CD20) was administered as two IV infusions, 1000 mg each, given two weeks apart at Day 0 and Week 2. Participants were pre-treated with corticosteroids, diphenhydramine, and acetaminophen. The appearance of the packaging and solutions used to administer rituximab/placebo was identical in both study arms.
11006575|NCT01086540|OG001|Outcome|Placebo|Placebo was administered as two IV infusions, given two weeks apart at Day 0 and Week 2. Participants were pre-treated with corticosteroids, diphenhydramine, and acetaminophen. The appearance of the packaging and solutions used to administer rituximab/placebo was identical in both study arms.
11006576|NCT01086540|EG000|Reported Event|Rituximab|Rituximab (a monoclonal antibody to CD20) was administered as two IV infusions, 1000 mg each, given two weeks apart at Day 0 and Week 2. Participants were pre-treated with corticosteroids, diphenhydramine, and acetaminophen. The appearance of the packaging and solutions used to administer rituximab/placebo was identical in both study arms.
11006577|NCT01086540|EG001|Reported Event|Placebo|Placebo was administered as two IV infusions, given two weeks apart at Day 0 and Week 2. Participants were pre-treated with corticosteroids, diphenhydramine, and acetaminophen. The appearance of the packaging and solutions used to administer rituximab/placebo was identical in both study arms.
11006578|NCT01086605|BG000|Baseline|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11006579|NCT01086605|BG001|Baseline|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11006580|NCT01086605|BG002|Baseline|Total|Total of all reporting groups
11006581|NCT01086605|FG000|Participant Flow|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11006582|NCT01086605|FG001|Participant Flow|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11006583|NCT01086605|OG000|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11006584|NCT01086605|OG001|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11124956|NCT01726803|FG000|Participant Flow|Usual Care|Usual care arm will receive management as recommended by practice guidelines and directed by the primary care provider. The recommended stepped care approach is used with initial management of advice and education only and no referral to physical therapy during the initial 4 weeks.
11124957|NCT01726803|FG001|Participant Flow|Early Physical Therapy With Usual Care|The Early Physical Therapy arm will receive the same advice and education intervention received by the usual care group and will be referred to receive 4 sessions of physical therapy during the first 4 weeks. The physical therapy protocol involves spinal manipulation and exercise.
11124958|NCT01726803|OG000|Outcome|Usual Care|"Usual care arm will receive management as recommended by practice guidelines and directed by the primary care provider. The recommended stepped care approach is used with initial management of advice and education only and no referral to physical therapy during the initial 4 weeks.~Early Physical Therapy: The early physical therapy arm includes 4 total sessions. The first 2 sessions include use of thrust spinal manipulation with exercises for range of motion and strengthening of the spine. The final 2 sessions include the exercise component only.~Usual Care: The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress."
11124959|NCT01726803|OG001|Outcome|Early Physical Therapy|"The Early Physical Therapy arm will receive the same advice and education intervention received by the usual care group and will be referred to receive 4 sessions of physical therapy during the first 4 weeks. The physical therapy protocol involves spinal manipulation and exercise.~Usual Care: The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress."
11124960|NCT01726803|EG000|Reported Event|Usual Care|"Usual care arm will receive management as recommended by practice guidelines and directed by the primary care provider. The recommended stepped care approach is used with initial management of advice and education only and no referral to physical therapy during the initial 4 weeks.~Early Physical Therapy: The early physical therapy arm includes 4 total sessions. The first 2 sessions include use of thrust spinal manipulation with exercises for range of motion and strengthening of the spine. The final 2 sessions include the exercise component only.~Usual Care: The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress."
11124961|NCT01726803|EG001|Reported Event|Early Physical Therapy|"The Early Physical Therapy arm will receive the same advice and education intervention received by the usual care group and will be referred to receive 4 sessions of physical therapy during the first 4 weeks. The physical therapy protocol involves spinal manipulation and exercise.~Usual Care: The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress."
11124962|NCT01727024|BG000|Baseline|All Randomized Participants|All participants who were randomized either to sequence 1 or sequence 2
11124963|NCT01727024|FG000|Participant Flow|Indacaterol Breezhaler® First, Then Tiotropium Respimat®|In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
11124964|NCT01727024|FG001|Participant Flow|Tiotropium Respimat® First, Then Indacaterol Breezhaler®|In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
11124965|NCT01727024|OG000|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
11124966|NCT01727024|OG001|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
11124967|NCT01727024|EG000|Reported Event|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
11124968|NCT01727024|EG001|Reported Event|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
11124969|NCT01727089|BG000|Baseline|Arm I (Bevacizumab)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11124970|NCT01727089|BG001|Baseline|Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105)|"Patients receive 10 mg\kg bevacizumab as in Arm I and anti-endoglin monoclonal antibody TRC105 10 mg\kg IV over 1-4 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Anti-Endoglin Chimeric Monoclonal Antibody TRC105: Given IV~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11124971|NCT01727089|BG002|Baseline|Total|Total of all reporting groups
11124972|NCT01727089|FG000|Participant Flow|Arm I (Bevacizumab)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10845269|NCT00266032|OG000|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
11124973|NCT01727089|FG001|Participant Flow|Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105)|"Patients receive 10 mg\kg bevacizumab as in Arm I and anti-endoglin monoclonal antibody TRC105 10 mg\kg IV over 1-4 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Anti-Endoglin Chimeric Monoclonal Antibody TRC105: Given IV~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11124974|NCT01727089|OG000|Outcome|Arm I (Bevacizumab)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11124975|NCT01727089|OG001|Outcome|Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105)|"Patients receive 10 mg\kg bevacizumab as in Arm I and anti-endoglin monoclonal antibody TRC105 10 mg\kg IV over 1-4 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Anti-Endoglin Chimeric Monoclonal Antibody TRC105: Given IV~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11124976|NCT01727089|EG000|Reported Event|Arm I (Bevacizumab)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11124977|NCT01727089|EG001|Reported Event|Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105)|"Patients receive 10 mg\kg bevacizumab as in Arm I and anti-endoglin monoclonal antibody TRC105 10 mg\kg IV over 1-4 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Anti-Endoglin Chimeric Monoclonal Antibody TRC105: Given IV~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11124978|NCT01727141|BG000|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
11124979|NCT01727141|BG001|Baseline|QAB149|27.5 ug b.i.d.
11124980|NCT01727141|BG002|Baseline|NVA237|12.5 ug b.i.d.
11124981|NCT01727141|BG003|Baseline|Placebo|b.i.d
11124982|NCT01727141|BG004|Baseline|Total|Total of all reporting groups
11124983|NCT01727141|FG000|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
11124984|NCT01727141|FG001|Participant Flow|QAB149|27.5 ug b.i.d.
11124985|NCT01727141|FG002|Participant Flow|NVA237|12.5 ug b.i.d.
11124986|NCT01727141|FG003|Participant Flow|Placebo|b.i.d
11124987|NCT01727141|OG000|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
11124988|NCT01727141|OG001|Outcome|QAB149|27.5 ug b.i.d.
11124989|NCT01727141|OG002|Outcome|NVA237|12.5 ug b.i.d.
11124990|NCT01727141|OG003|Outcome|Placebo|b.i.d
11124991|NCT01727141|EG000|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
11124992|NCT01727141|EG001|Reported Event|QAB149|27.5 ug b.i.d.
11124993|NCT01727141|EG002|Reported Event|NVA237|12.5 ug b.i.d.
11124994|NCT01727141|EG003|Reported Event|Placebo|b.i.d
11124995|NCT01727154|BG000|Baseline|Sipuleucel-T|Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
11124996|NCT01727154|FG000|Participant Flow|Sipuleucel-T|Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
11124997|NCT01727154|OG000|Outcome|Sipuleucel-T|Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
11124998|NCT01727154|EG000|Reported Event|Sipuleucel-T|Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
11124999|NCT01727180|BG000|Baseline|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
11125000|NCT01727180|FG000|Participant Flow|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
11125001|NCT01727180|OG000|Outcome|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
11125002|NCT01727180|EG000|Reported Event|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
11125003|NCT01727258|BG000|Baseline|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
11125004|NCT01727258|BG001|Baseline|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
11125005|NCT01727258|BG002|Baseline|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
11125006|NCT01727258|BG003|Baseline|Total|Total of all reporting groups
11125007|NCT01727258|FG000|Participant Flow|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
11125008|NCT01727258|FG001|Participant Flow|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
11125009|NCT01727258|FG002|Participant Flow|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
11125010|NCT01727258|OG000|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
11125011|NCT01727258|OG001|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
11125012|NCT01727258|OG002|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
11125013|NCT01727258|EG000|Reported Event|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
11006585|NCT01086605|OG000|Outcome|Arm I/Group A + Arm II/Group B|"Arm I/Group A: Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Arm II/Group B: Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
11006586|NCT01086605|EG000|Reported Event|Arm I/Group A|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11006587|NCT01086605|EG001|Reported Event|Arm II/Group B|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11006588|NCT01086761|BG000|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
11006589|NCT01086761|BG001|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
11006590|NCT01086761|BG002|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
11006591|NCT01086761|BG003|Baseline|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
11006592|NCT01086761|BG004|Baseline|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
11006593|NCT01086761|BG005|Baseline|Total|Total of all reporting groups
11006594|NCT01086761|FG000|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
11006595|NCT01086761|FG001|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
11006596|NCT01086761|FG002|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
11006597|NCT01086761|FG003|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
11006598|NCT01086761|FG004|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
11006599|NCT01086761|FG005|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
11006600|NCT01086761|OG000|Outcome|MP0112|Single intravitreal injection of MP0112 in the study eye of one of the following doses: 0.04 mg, 0.15 mg, 0.4 mg, 1.0 mg or 2.0 mg.
11006601|NCT01086761|OG000|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
11006602|NCT01086761|OG001|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
11006603|NCT01086761|OG002|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
11006604|NCT01086761|OG003|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
11006605|NCT01086761|OG004|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
11006606|NCT01086761|EG000|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
11006607|NCT01086761|EG001|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
11006608|NCT01086761|EG002|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
11006609|NCT01086761|EG003|Reported Event|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
11006610|NCT01086761|EG004|Reported Event|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
11006611|NCT01086852|BG000|Baseline|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
11006612|NCT01086852|FG000|Participant Flow|Active Treatment With FACTOR X|Four subjects underwent 4 major surgeries with active treatment (FACTOR X)
11006613|NCT01086852|OG000|Outcome|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
11006614|NCT01086852|OG000|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
11006615|NCT01086852|EG000|Reported Event|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
11006616|NCT01086969|BG000|Baseline|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
11006617|NCT01086969|BG001|Baseline|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
11006618|NCT01086969|BG002|Baseline|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
11006619|NCT01086969|BG003|Baseline|Total|Total of all reporting groups
11006620|NCT01086969|FG000|Participant Flow|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
11006621|NCT01086969|FG001|Participant Flow|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
11006622|NCT01086969|FG002|Participant Flow|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
11006623|NCT01086969|OG000|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
11006624|NCT01086969|OG001|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
11006625|NCT01086969|OG002|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
11006626|NCT01086969|EG000|Reported Event|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
11006627|NCT01086969|EG001|Reported Event|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
11006628|NCT01086969|EG002|Reported Event|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
11006629|NCT01087489|BG000|Baseline|All Study Participants|Each participant was randomly assigned to receive either anesthetic preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.
11006630|NCT01087489|FG000|Participant Flow|Bilateral|Participants were given bilateral injections with 4% lidocaine prep in one eye and 3.5% lidocaine gel in the other.
11006631|NCT01087489|FG001|Participant Flow|Unilateral|Each participant was randomly assigned to receive an intravitreal injection with 4% lidocaine prep on one visit and 3.5% lidocaine gel on the next visit.
11006632|NCT01087489|OG000|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
11006633|NCT01087489|OG001|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
11006634|NCT01087489|EG000|Reported Event|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
11006635|NCT01087489|EG001|Reported Event|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
11006636|NCT01087502|BG000|Baseline|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
11006637|NCT01087502|BG001|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006638|NCT01087502|BG002|Baseline|Total|Total of all reporting groups
11006639|NCT01087502|FG000|Participant Flow|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
11006640|NCT01087502|FG001|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006641|NCT01087502|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
11006642|NCT01087502|OG001|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006643|NCT01087502|OG000|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
11006644|NCT01087502|OG000|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006645|NCT01087502|EG000|Reported Event|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
11006646|NCT01087502|EG001|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
11006647|NCT01087528|BG000|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
11006648|NCT01087528|FG000|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
11006649|NCT01087528|OG000|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
11006650|NCT01087528|OG000|Outcome|PillCam COLON|All subjects received ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy. Results compare capsule vs. colonoscopy.
11006651|NCT01087528|OG001|Outcome|Standard Colonoscopy|All subjects received ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy. Results compare capsule vs. colonoscopy.
11006652|NCT01087528|EG000|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
11006653|NCT01087541|BG000|Baseline|Intervention|Behavioural program of education for health professionals of the study
11006654|NCT01087541|BG001|Baseline|Control Group|Usual healthcare of diabetics patients
11006655|NCT01087541|BG002|Baseline|Total|Total of all reporting groups
11006656|NCT01087541|FG000|Participant Flow|Intervention|Behavioural program of education for health professionals of the study
11006657|NCT01087541|FG001|Participant Flow|Control Group|Usual healthcare of diabetics patients
11006658|NCT01087541|OG000|Outcome|Intervention|Behavioural program of education for health professionals of the study
11006659|NCT01087541|OG001|Outcome|Control Group|Usual healthcare of diabetics patients
11006660|NCT01087541|EG000|Reported Event|Intervention Group|Intervention group: educational program
11006661|NCT01087541|EG001|Reported Event|Control Group|Usual healthcare
11006662|NCT01087723|BG000|Baseline|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
11125014|NCT01727258|EG001|Reported Event|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
11125015|NCT01727258|EG002|Reported Event|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
11336354|NCT03565315|OG002|Outcome|Overall 10E8VLS Groups|Total number of participants who received an SC injection of 10E8VLS alone - Groups 1 and 2 only received 10E8VLS
11006663|NCT01087723|BG001|Baseline|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI."
11006664|NCT01087723|BG002|Baseline|Total|Total of all reporting groups
11006665|NCT01087723|FG000|Participant Flow|Bivalirudin|Given immediately upon enrolment as an intravenous (IV) bolus of 0.75 milligrams/kilogram (mg/kg), followed immediately by an infusion of 1.75 mg/kg/hour (mg/kg/h). This infusion was to be run continuously until completion of percutaneous coronary intervention (PCI), at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
11006666|NCT01087723|FG001|Participant Flow|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of ST segment elevation acute coronary syndrome (STE-ACS ), not including bivalirudin: unfractionated heparin (UFH) (100 international units/kg [IU/kg] without glycoprotein IIb/IIIa inhibitor [GPI] and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-micrograms/kilogram [μg/kg] IV boluses with a 10-minute [min] interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or low molecular weight heparin (LMWH) with or without GPI and is referred to as heparins with optional GPI."
11006667|NCT01087723|OG000|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
11006668|NCT01087723|OG001|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI."
11006669|NCT01087723|EG000|Reported Event|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
11006670|NCT01087723|EG001|Reported Event|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI."
11006671|NCT01087736|BG000|Baseline|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
11006672|NCT01087736|BG001|Baseline|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
11006673|NCT01087736|BG002|Baseline|Total|Total of all reporting groups
11006674|NCT01087736|FG000|Participant Flow|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
11006675|NCT01087736|FG001|Participant Flow|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
11006676|NCT01087736|OG000|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
11125016|NCT01727297|BG000|Baseline|Reveal Implantable Cardiac Monitor Implant Attempted|Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
11125017|NCT01727297|FG000|Participant Flow|Reveal Implantable Cardiac Monitor Implant Attempted|Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
11125018|NCT01727297|FG001|Participant Flow|No Reveal Implantable Cardiac Monitor Implant Attempt|Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor
11125019|NCT01727297|OG000|Outcome|Primary Objective Analysis Cohort|Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), who also (1) have post-implant device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal ICM implant, and (4) satisfy the Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled) (CHADS2) inclusion criteria for the study (CHADS2 score of 3 or higher, or a CHADS2 score of 2 along with chronic obstructive pulmonary disease, sleep apnea, renal impairment, or coronary artery disease)
11125020|NCT01727297|OG000|Outcome|AF Predictors Analysis Cohort: AF Episodes|Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), and who (1) have post-implant ICM device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal implant, and (4) experienced an AF episode lasting at least 6 minutes during follow-up.
11125021|NCT01727297|OG001|Outcome|AF Predictors Analysis Cohort: No AF Episodes|Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), and who (1) have post-implant ICM device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal implant, and (4) did not experience an AF episode lasting at least 6 minutes during follow-up.
11125022|NCT01727297|OG000|Outcome|First Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a follow-up visit in which new AF episodes were diagnosed"
11125023|NCT01727297|OG001|Outcome|Second Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 2nd follow-up visit in which new AF episodes were diagnosed"
11125024|NCT01727297|OG002|Outcome|Third Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 3rd follow-up visit in which new AF episodes were diagnosed"
11125025|NCT01727297|OG003|Outcome|Fourth Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 4th follow-up visit in which new AF episodes were diagnosed"
11125026|NCT01727297|OG004|Outcome|Fifth Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 5th follow-up visit in which new AF episodes were diagnosed"
11125027|NCT01727297|OG005|Outcome|Sixth Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 6th follow-up visit in which new AF episodes were diagnosed"
11125028|NCT01727297|EG000|Reported Event|Reveal Implantable Cardiac Monitor Implant Attempted|Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
11125029|NCT01727297|EG001|Reported Event|No Reveal Implantable Cardiac Monitor Implant Attempt|Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor
11125030|NCT01727336|BG000|Baseline|Part 1 Dalantercept 0.6 mg/kg|Dose escalation cohort 1: dalantercept 0.6 mg/kg
11125031|NCT01727336|BG001|Baseline|Part 1 Dalantercept 0.9 mg/kg|Dose escalation cohort 2: dalantercept 0.9 mg/kg
11125032|NCT01727336|BG002|Baseline|Part 1 Dalantercept 1.2 mg/kg|Dose escalation cohort 3: dalantercept 1.2 mg/kg
11125033|NCT01727336|BG003|Baseline|Part 1 Dalantercept 1.5 mg/kg|Dose escalation cohort 4: dalantercept 1.5 mg/kg
11125034|NCT01727336|BG004|Baseline|Part 2 Dalantercept 0.9 mg/kg Plus Axitinib|Subcutaneous (SC) injection of Dalantercept once every 3 weeks and oral axitinib 5 mg BID for continuous dosing.
11125035|NCT01727336|BG005|Baseline|Placebo Plus Axitinib|Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing
11125036|NCT01727336|BG006|Baseline|Total|Total of all reporting groups
11125037|NCT01727336|FG000|Participant Flow|Part 1 Dalantercept 0.6 mg/kg|Dose escalation cohort 1: dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID
11125038|NCT01727336|FG001|Participant Flow|Part 1 Dalantercept 0.9 mg/kg|Dose escalation cohort 2: dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID
11125039|NCT01727336|FG002|Participant Flow|Part 1: Dalantercept 1.2 mg/kg|Part 1 cohort 3: dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID
11125040|NCT01727336|FG003|Participant Flow|Part 1: Dalantercept 1.5 mg/kg|Dose escalation cohort 4: dalantercept 1.5 mg/kg
11125041|NCT01727336|FG004|Participant Flow|Part 2: Dalantercept 0.9 mg/kg Plus Axitinib|Subcutaneous (SC) injection of Dalantercept once every 3 weeks and oral axitinib 5 mg PO BID for continuous dosing.
11125042|NCT01727336|FG005|Participant Flow|Part 2: Placebo Plus Axitinib|Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg PO BID for continuous dosing
11125043|NCT01727336|OG000|Outcome|Part 1 Dalantercept 0.6 mg/kg|Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID
11125044|NCT01727336|OG001|Outcome|Part 1 Dalantercept 0.9 mg/kg|Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID
11125045|NCT01727336|OG002|Outcome|Part 1 Dalantercept 1.2 mg/kg|Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID
11125046|NCT01727336|OG003|Outcome|Part 1 Dalantercept 1.5 mg/kg|Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
11125047|NCT01727336|OG000|Outcome|Part 2: Dalantercept 0.9 mg/kg Plus Axitinib|Subcutaneous (SC) injection of Dalantercept 0.9 mg/kg once every 3 weeks and Oral axitinib 5 mg BID for continuous dosing.
11125048|NCT01727336|OG001|Outcome|Part 2: Placebo Plus Axitinib|Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing
11125049|NCT01727336|OG000|Outcome|Part 1 Dalantercept 0.6 mg/kg|Dose escalation cohort 1: dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID
11125050|NCT01727336|OG001|Outcome|Part 1 Dalantercept 0.9 mg/kg|Dose escalation cohort 2: dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID
11125051|NCT01727336|OG002|Outcome|Part 1: Dalantercept 1.2 mg/kg|Part 1 cohort 3: dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID
11125052|NCT01727336|OG000|Outcome|Part 2: Dalantercept 0.9 mg/kg Plus Axitinib|Subcutaneous (SC) injection of Dalantercept 0.9 mg/kg once every 3 weeks and oral axitinib 5 mg BID for continuous dosing.
11125053|NCT01727336|OG000|Outcome|Dalantercept 0.9 mg/kg Plus Axitinib|Subcutaneous (SC) injection of Dalantercept 0.9 mg/kg once every 3 weeks and oral axitinib 5 mg BID for continuous dosing.
11125054|NCT01727336|OG000|Outcome|Part 1 Participants|Pooled number of Part 1 participants across the dose escalation groups 0.6 mg/kg (N=6), 0.9 mg/kg (N=9) and 1.2 mg/kg (N=14); total N=29 subjects
11125055|NCT01727336|EG000|Reported Event|Part 1: Dalantercept 0.6 mg/kg|Part 1 cohort 1: dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID
11125056|NCT01727336|EG001|Reported Event|Part 1: Dalantercept 0.9 mg/kg|Part 1 cohort 1: dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID
11125057|NCT01727336|EG002|Reported Event|Part 1: Dalantercept 1.2 mg/kg|Part 1 cohort 1: dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID
11125058|NCT01727336|EG003|Reported Event|Part 1: Dalantercept 1.5 mg/kg|Part 1 cohort 1: dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
11125059|NCT01727336|EG004|Reported Event|Part 2: Dalantercept 0.9 mg/kg Plus Axitinib|Subcutaneous (SC) injection of Dalantercept 0.9 mg/kg once every 3 weeks and oral axitinib 5 mg BID for continuous dosing.
11125060|NCT01727336|EG005|Reported Event|Part 2: Placebo Plus Axitinib|Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing
11126870|NCT01736124|EG001|Reported Event|Active Control|As for the CCT intervention group, these randomly selected subjects performed three games each session from the same set of Cognifit computer games over the same eight week schedule. The activity differed only in the program did not target training games nor adaptive in their level of challenge based on prior performance and no cognitive score was provided at the end of the session.
11126871|NCT01736176|BG000|Baseline|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
11126872|NCT01736176|FG000|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|Participants had a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.
11126873|NCT01736176|OG000|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
11126874|NCT01736176|OG000|Outcome|Week 1-4|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure through week 4.
11126875|NCT01736176|OG001|Outcome|Overall|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure and no more than 30 days after the end of the LCIG Treatment Period.
11126876|NCT01736176|OG000|Outcome|Week 12|
11126877|NCT01736176|OG001|Outcome|Week 60|
11126878|NCT01736176|EG000|Reported Event|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
11126879|NCT01736189|BG000|Baseline|Participants Treated With Adalimumab|40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks
11126880|NCT01736189|FG000|Participant Flow|Participants Treated With Adalimumab|40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks
11126881|NCT01736189|OG000|Outcome|Participants Treated With Adalimumab|40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks
11126882|NCT01736189|EG000|Reported Event|Participants Treated With Adalimumab|40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks
11125061|NCT01727414|BG000|Baseline|Inattentive Type|
11125062|NCT01727414|BG001|Baseline|Combined Type|
11125063|NCT01727414|BG002|Baseline|Total|Total of all reporting groups
11125064|NCT01727414|FG000|Participant Flow|Inattentive Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.~Placebo: capsule, frequency - each AM, duration - 1 week"
11125065|NCT01727414|FG001|Participant Flow|Combined Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.~OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
11125066|NCT01727414|OG000|Outcome|Inattentive Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.~OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
11125067|NCT01727414|OG001|Outcome|Combined Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.~OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
11125068|NCT01727414|EG000|Reported Event|Inattentive Type|Children meeting DSM-IV criteria for ADHD-inattentive type.
11125069|NCT01727414|EG001|Reported Event|Combined Type|Children meeting DSM-IV criteria for ADHD-combined type.
11125070|NCT01727505|BG000|Baseline|Study Population|"This is a crossover study. Infants were randomly assigned to one of two sequences.~Sequence A consisted of 24 hours of Conventional Mechanical Ventilation followed by 24 hours of Volume Guarantee Ventilation.~Sequence B consisted of 24 hours of Volume Guarantee Ventilation followed by 24 hours of Conventional Mechanical Ventilation."
11125071|NCT01727505|FG000|Participant Flow|Sequence A: Conventional-Volume Guarantee|"This is a crossover study. Each patient is randomly assigned to one of two sequences.~Sequence A consisted of a 24-hour period during which the infant received conventional mechanical ventilation followed by a 24 hour period during which the infant received volume guarantee ventilation."
11125072|NCT01727505|FG001|Participant Flow|Sequence B: Volume Guarantee-Conventional|"This is a crossover study. Each patient is randomly assigned to one of two sequences.~Sequence B consisted of a 24-hour period during which the infant received volume guarantee ventilation followed by a 24 hour period during which the infant received conventional mechanical ventilation."
11125073|NCT01727505|OG000|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
11125074|NCT01727505|OG001|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
11125075|NCT01727505|EG000|Reported Event|Conventional Mechanical Ventilation Period|"This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~These data represent the 24 hours of Conventional Mechanical Ventilation."
11125076|NCT01727505|EG001|Reported Event|Volume Guarantee Ventilation Period|"This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~These data represent the 24 hours of Volume Guarantee Ventilation."
11125077|NCT01727700|BG000|Baseline|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
11125078|NCT01727700|BG001|Baseline|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
11125079|NCT01727700|BG002|Baseline|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
11125080|NCT01727700|BG003|Baseline|Total|Total of all reporting groups
11125081|NCT01727700|FG000|Participant Flow|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
11125082|NCT01727700|FG001|Participant Flow|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
11125083|NCT01727700|FG002|Participant Flow|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
11126883|NCT01736215|BG000|Baseline|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
11006677|NCT01087736|OG001|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
11006678|NCT01087736|EG000|Reported Event|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
11006679|NCT01087736|EG001|Reported Event|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
11006680|NCT01087762|BG000|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
11006681|NCT01087762|BG001|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
11006682|NCT01087762|BG002|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
11006683|NCT01087762|BG003|Baseline|Total Title|
11006684|NCT01087762|FG000|Participant Flow|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
11006685|NCT01087762|FG001|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
11006686|NCT01087762|FG002|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
11006687|NCT01087762|FG003|Participant Flow|All CZP 200 mg|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
11006688|NCT01087762|FG004|Participant Flow|All CZP 400 mg|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
11006689|NCT01087762|OG000|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
11006690|NCT01087762|OG001|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
11006691|NCT01087762|OG002|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
11006692|NCT01087762|OG003|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
11006693|NCT01087762|EG000|Reported Event|All CZP 200 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
11125084|NCT01727700|OG000|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
11125085|NCT01727700|OG001|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
11125086|NCT01727700|OG002|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
11125087|NCT01727700|EG000|Reported Event|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
11125088|NCT01727700|EG001|Reported Event|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
11125089|NCT01727700|EG002|Reported Event|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
11125090|NCT01727713|BG000|Baseline|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
11125091|NCT01727713|FG000|Participant Flow|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
11125092|NCT01727713|OG000|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
11125093|NCT01727713|EG000|Reported Event|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
11125094|NCT01727726|BG000|Baseline|Brexpiprazole + ADT|"Brexpiprazole, flexible dose and assigned ADT~Brexpiprazole: tablet/capsule"
11125095|NCT01727726|BG001|Baseline|Seroquel XR + ADT|"Seroquel XR, flexible dose and assigned ADT~Seroquel XR: tablet/capsule"
11125096|NCT01727726|BG002|Baseline|Placebo + ADT|"Matching Placebo and assigned ADT~Placebo: tablet/capsule"
11125097|NCT01727726|BG003|Baseline|Total|Total of all reporting groups
11125098|NCT01727726|FG000|Participant Flow|Brexpiprazole + ADT|"Brexpiprazole, flexible dose and assigned ADT~Brexpiprazole: tablet/capsule at 1 mg, 2 mg, 3 mg."
11125099|NCT01727726|FG001|Participant Flow|Seroquel XR + ADT|"Seroquel XR, flexible dose and assigned ADT~Seroquel XR: tablet/capsule at 50 mg, 150 mg, 300 mg."
11125100|NCT01727726|FG002|Participant Flow|Placebo + ADT|"Matching Placebo and assigned ADT~Placebo: tablet/capsule"
11125101|NCT01727726|OG000|Outcome|Brexpiprazole + ADT|"Brexpiprazole, flexible dose and assigned ADT~Brexpiprazole: tablet/capsule"
11125102|NCT01727726|OG001|Outcome|Seroquel XR + ADT|"Seroquel XR, flexible dose and assigned ADT~Seroquel XR: tablet/capsule"
11125103|NCT01727726|OG002|Outcome|Placebo + ADT|"Matching Placebo and assigned ADT~Placebo: tablet/capsule"
11125104|NCT01727726|EG000|Reported Event|Brexpiprazole + ADT|"Brexpiprazole, flexible dose and assigned ADT~Brexpiprazole: tablet/capsule"
11125105|NCT01727726|EG001|Reported Event|Seroquel XR + ADT|"Seroquel XR, flexible dose and assigned ADT~Seroquel XR: tablet/capsule"
11125106|NCT01727726|EG002|Reported Event|Placebo + ADT|"Matching Placebo and assigned ADT~Placebo: tablet/capsule"
11125107|NCT01727765|BG000|Baseline|Experimental|"6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength~inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure."
11125108|NCT01727765|BG001|Baseline|Sham Comparator|"6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.~inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure."
11125109|NCT01727765|BG002|Baseline|Total|Total of all reporting groups
11126884|NCT01736215|FG000|Participant Flow|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
11126885|NCT01736215|OG000|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
11125110|NCT01727765|FG000|Participant Flow|Experimental|"6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength~inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure."
11125111|NCT01727765|FG001|Participant Flow|Sham Comparator|"6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.~inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure."
11125112|NCT01727765|OG000|Outcome|Experimental|Undertook 6 weeks of real IMT
11125113|NCT01727765|OG001|Outcome|Sham|undertook 6 weeks of sham IMT
11125114|NCT01727765|EG000|Reported Event|Experimental|"6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength~inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure."
11125115|NCT01727765|EG001|Reported Event|Sham Comparator|"6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.~inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure."
11125116|NCT01727791|BG000|Baseline|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
11125117|NCT01727791|FG000|Participant Flow|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
11125118|NCT01727791|OG000|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
11125119|NCT01727791|EG000|Reported Event|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
11125120|NCT01727895|BG000|Baseline|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
11125121|NCT01727895|BG001|Baseline|Control Group|No intervention
11125122|NCT01727895|BG002|Baseline|Total|Total of all reporting groups
11125123|NCT01727895|FG000|Participant Flow|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
11125124|NCT01727895|FG001|Participant Flow|Control Group|No intervention
11125125|NCT01727895|OG000|Outcome|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
11125126|NCT01727895|OG001|Outcome|Control Group|No intervention
11125127|NCT01727895|EG000|Reported Event|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
11125128|NCT01727895|EG001|Reported Event|Control Group|No intervention
11125129|NCT01728077|BG000|Baseline|Brivaracetam Focal Epilepsy|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day.
11125130|NCT01728077|BG001|Baseline|Brivaracetam Generalized Epilepsy|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day.
11125131|NCT01728077|BG002|Baseline|Total Title|
11125132|NCT01728077|FG000|Participant Flow|Brivaracetam Focal Epilepsy|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day.
11126886|NCT01736215|EG000|Reported Event|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
11006694|NCT01087762|EG001|Reported Event|All CZP 400 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
11006695|NCT01087762|EG002|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg.
11006696|NCT01087762|EG003|Reported Event|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
11006697|NCT01087775|BG000|Baseline|Cognitive Training|"Plasticity Based Adaptive Cognitive Remediation (PACR)~Cognitive Training: Plasticity Based Adaptive Cognitive Remediation (PACR)"
11006698|NCT01087775|FG000|Participant Flow|Cognitive Training|"Plasticity Based Adaptive Cognitive Remediation (PACR)~Cognitive Training: Plasticity Based Adaptive Cognitive Remediation (PACR)"
11006699|NCT01087775|OG000|Outcome|Treatment|Treatment Arm
11006700|NCT01087775|OG000|Outcome|Cognitive Training|"Plasticity Based Adaptive Cognitive Remediation (PACR)~Cognitive Training: Plasticity Based Adaptive Cognitive Remediation (PACR)"
11006701|NCT01087775|EG000|Reported Event|Cognitive Training|"Plasticity Based Adaptive Cognitive Remediation (PACR)~Cognitive Training: Plasticity Based Adaptive Cognitive Remediation (PACR)"
11006702|NCT01087788|BG000|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
11006703|NCT01087788|BG001|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
11006704|NCT01087788|BG002|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
11006705|NCT01087788|BG003|Baseline|Total Title|
11006706|NCT01087788|FG000|Participant Flow|Placebo|"Matching Placebo (PBO) to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
11006707|NCT01087788|FG001|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
11006708|NCT01087788|FG002|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
11006709|NCT01087788|OG000|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
11006710|NCT01087788|OG001|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
11006711|NCT01087788|OG002|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
11006712|NCT01087788|OG003|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
11006713|NCT01087788|EG000|Reported Event|All CZP 200 mg Q2W|"This arm includes all subjects who were randomized to CZP 200 mg Q2W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 200 mg Q2W.~Subjects received one injection of 200 mg CZP and one injection of Placebo every two weeks to maintain the study blind."
11006714|NCT01087788|EG001|Reported Event|All CZP 400 mg Q4W|"This arm includes all subjects who were randomized to CZP 400 mg Q4W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 400 mg Q4W.~Subjects received two injections of Placebo every four weeks in between the two injections of 200 mg CZP to maintain the study blind."
11006715|NCT01087788|EG002|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg Q2W and arm All CZP 400 mg Q4W.
11006716|NCT01087801|BG000|Baseline|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
11006717|NCT01087801|BG001|Baseline|Placebo|Saline for Injection 0.1 mL/kg IV
11006718|NCT01087801|BG002|Baseline|Total|Total of all reporting groups
11006719|NCT01087801|FG000|Participant Flow|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
11126887|NCT01736241|BG000|Baseline|2 mg LY3053102|LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
11006720|NCT01087801|FG001|Participant Flow|Placebo|Saline for Injection 0.1 mL/kg IV
11006721|NCT01087801|OG000|Outcome|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
11006722|NCT01087801|OG001|Outcome|Placebo|Saline for Injection 0.1 mL/kg IV
11006723|NCT01087801|EG000|Reported Event|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
11006724|NCT01087801|EG001|Reported Event|Placebo|Saline for Injection 0.1 mL/kg IV
11006725|NCT01087814|BG000|Baseline|Efavirenz|Both arms received both versions of the drug during the course of the study.
11006726|NCT01087814|BG001|Baseline|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
11006727|NCT01087814|BG002|Baseline|Total|Total of all reporting groups
11006728|NCT01087814|FG000|Participant Flow|Efavirenz First, Then Over-encapsulated Efavirenz|This arm received efavirenz for five days, then over-encapsulated efavirenz for five days.
11006729|NCT01087814|FG001|Participant Flow|Over-encapsulated Efavirenz First, Then Efavirenz|This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.
11006730|NCT01087814|OG000|Outcome|Efavirenz (Tablet)|All subjects took efavirenz.
11006731|NCT01087814|OG001|Outcome|Over-encapsulated Efavirenz|All subjects took over-encapsulated efavirenz.
11006732|NCT01087814|EG000|Reported Event|Efavirenz|Both arms received both versions of the drug during the course of the study.
11006733|NCT01087814|EG001|Reported Event|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
11006734|NCT01087905|BG000|Baseline|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
11006735|NCT01087905|BG001|Baseline|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
11006736|NCT01087905|BG002|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
11006737|NCT01087905|BG003|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
11006738|NCT01087905|BG004|Baseline|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
11006739|NCT01087905|BG005|Baseline|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
11006740|NCT01087905|BG006|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
11006741|NCT01087905|BG007|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
11006742|NCT01087905|BG008|Baseline|Total|Total of all reporting groups
11006743|NCT01087905|FG000|Participant Flow|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
11006744|NCT01087905|FG001|Participant Flow|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
11006745|NCT01087905|FG002|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
11006746|NCT01087905|FG003|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
11006747|NCT01087905|FG004|Participant Flow|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
11006748|NCT01087905|FG005|Participant Flow|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
11006749|NCT01087905|FG006|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
11006750|NCT01087905|FG007|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
11006751|NCT01087905|OG000|Outcome|Two Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
11006752|NCT01087905|OG001|Outcome|Six Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
11006753|NCT01087905|OG002|Outcome|NRT Monotherapy (Nicotine Patch Only)|Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
11006754|NCT01087905|OG003|Outcome|NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)|Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
11006755|NCT01087905|OG004|Outcome|Standard Cessation Counseling (No CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
11006756|NCT01087905|OG005|Outcome|Standard Cessation Counseling Plus CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
11006757|NCT01087905|OG000|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
11006758|NCT01087905|OG001|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
11006759|NCT01087905|OG002|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
11006760|NCT01087905|OG003|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
11006761|NCT01087905|EG000|Reported Event|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
11006762|NCT01087905|EG001|Reported Event|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
11006763|NCT01087905|EG002|Reported Event|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
11006764|NCT01087905|EG003|Reported Event|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
11006765|NCT01087918|BG000|Baseline|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
11006766|NCT01087918|BG001|Baseline|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
11006767|NCT01087918|BG002|Baseline|Total|Total of all reporting groups
11006768|NCT01087918|FG000|Participant Flow|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
11006769|NCT01087918|FG001|Participant Flow|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
11006770|NCT01087918|OG000|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
11006771|NCT01087918|OG001|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
11006772|NCT01087918|OG000|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week
11006773|NCT01087918|OG001|Outcome|Strength Training|16 sessions of 45 minutes of strength training 4 times a week
11006774|NCT01087918|OG000|Outcome|First RAGT, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
11006775|NCT01087918|OG001|Outcome|First Strength Training, Then RAGT|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
11125133|NCT01728077|FG001|Participant Flow|Brivaracetam Generalized Epilepsy|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day.
11125134|NCT01728077|OG000|Outcome|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
11125135|NCT01728077|OG001|Outcome|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
11125136|NCT01728077|OG000|Outcome|Brivaracetam Focal Epilepsy (EAS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
11125137|NCT01728077|EG000|Reported Event|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
11125138|NCT01728077|EG001|Reported Event|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
11125139|NCT01728116|BG000|Baseline|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
11125140|NCT01728116|BG001|Baseline|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
11125141|NCT01728116|BG002|Baseline|Total|Total of all reporting groups
11125142|NCT01728116|FG000|Participant Flow|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.
11125143|NCT01728116|FG001|Participant Flow|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.
11125144|NCT01728116|OG000|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
11125145|NCT01728116|OG001|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
11125146|NCT01728116|OG000|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
11125147|NCT01728116|EG000|Reported Event|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
11125148|NCT01728116|EG001|Reported Event|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
11125149|NCT01728194|BG000|Baseline|MDD (Escitalopram Tx)|"Target dose 20mg for 12 weeks~Escitalopram: 20 mg target dose for 12 weeks"
11125150|NCT01728194|BG001|Baseline|Control|No treatment (healthy comparison participants with no history or presence of psychiatric disorder)
11125151|NCT01728194|BG002|Baseline|Total|Total of all reporting groups
11125152|NCT01728194|FG000|Participant Flow|MDD (Escitalopram Tx)|"Target dose 20mg for 12 weeks~Escitalopram: 20 mg target dose for 12 weeks"
11125153|NCT01728194|FG001|Participant Flow|Control|No treatment (healthy comparison participants with no history or presence of psychiatric disorder)
11125154|NCT01728194|OG000|Outcome|Escitalopram|Patients diagnosed with MDD receiving 12-week Escitalopram intervention
11125155|NCT01728194|OG001|Outcome|Control|No Intervention / Non-psychiatric comparison participants
11125156|NCT01728194|EG000|Reported Event|MDD (Escitalopram Tx)|"Target dose 20mg for 12 weeks~Escitalopram: 20 mg target dose for 12 weeks"
11125157|NCT01728194|EG001|Reported Event|Control|No treatment (healthy comparison participants with no history or presence of psychiatric disorder)
11125158|NCT01728246|BG000|Baseline|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
11125159|NCT01728246|BG001|Baseline|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
11125160|NCT01728246|BG002|Baseline|Total|Total of all reporting groups
11125161|NCT01728246|FG000|Participant Flow|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
11125162|NCT01728246|FG001|Participant Flow|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
11125163|NCT01728246|OG000|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
11125164|NCT01728246|OG001|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
11125165|NCT01728246|EG000|Reported Event|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
11125166|NCT01728246|EG001|Reported Event|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
11125167|NCT01728324|BG000|Baseline|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
11125168|NCT01728324|BG001|Baseline|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
11125169|NCT01728324|BG002|Baseline|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
10845270|NCT00266032|OG001|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
11125170|NCT01728324|BG003|Baseline|Total|Total of all reporting groups
11125171|NCT01728324|FG000|Participant Flow|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
11125172|NCT01728324|FG001|Participant Flow|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
11125173|NCT01728324|FG002|Participant Flow|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
11125174|NCT01728324|OG000|Outcome|24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
11125175|NCT01728324|OG001|Outcome|16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
11125176|NCT01728324|OG000|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
11125177|NCT01728324|OG001|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
11125178|NCT01728324|OG002|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
11125179|NCT01728324|EG000|Reported Event|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
11125180|NCT01728324|EG001|Reported Event|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
11125181|NCT01728324|EG002|Reported Event|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
11125182|NCT01728337|BG000|Baseline|Xeomin and Dysport|Xeomin® was injected on the one side of the forehead and Dysport® was injected on the other side of the forehead.
11125183|NCT01728337|FG000|Participant Flow|Dysport and Xeomin|Dysport® was injected on the one side of the forehead and Xeomin® was injected on the other side of the forehead.
11125184|NCT01728337|OG000|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
11125185|NCT01728337|OG001|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
11125186|NCT01728337|EG000|Reported Event|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
11125187|NCT01728337|EG001|Reported Event|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
11126888|NCT01736241|BG001|Baseline|7 mg LY3053102|LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
11125188|NCT01728376|BG000|Baseline|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125189|NCT01728376|BG001|Baseline|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125190|NCT01728376|BG002|Baseline|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125191|NCT01728376|BG003|Baseline|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125192|NCT01728376|BG004|Baseline|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125193|NCT01728376|BG005|Baseline|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125194|NCT01728376|BG006|Baseline|Total|Total of all reporting groups
11125195|NCT01728376|FG000|Participant Flow|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125196|NCT01728376|FG001|Participant Flow|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125197|NCT01728376|FG002|Participant Flow|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125198|NCT01728376|FG003|Participant Flow|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125199|NCT01728376|FG004|Participant Flow|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125200|NCT01728376|FG005|Participant Flow|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125201|NCT01728376|OG000|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125202|NCT01728376|OG001|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125203|NCT01728376|OG002|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125204|NCT01728376|OG003|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11126889|NCT01736241|BG002|Baseline|20 mg LY3053102|LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
11125205|NCT01728376|OG004|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125206|NCT01728376|OG005|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125207|NCT01728376|EG000|Reported Event|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125208|NCT01728376|EG001|Reported Event|Comparator - 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125209|NCT01728376|EG002|Reported Event|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125210|NCT01728376|EG003|Reported Event|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125211|NCT01728376|EG004|Reported Event|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
11125212|NCT01728376|EG005|Reported Event|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
11125213|NCT01728454|BG000|Baseline|Placebo|Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.
11125214|NCT01728454|BG001|Baseline|Telapristone Acetate 6 mg|Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.
11125215|NCT01728454|BG002|Baseline|Telapristone Acetate 12 mg|Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
11125216|NCT01728454|BG003|Baseline|Total|Total of all reporting groups
11125217|NCT01728454|FG000|Participant Flow|Placebo|Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 milligrams (mg)/day separated by an off-drug interval (ODI) in Stage 3.
11125218|NCT01728454|FG001|Participant Flow|Telapristone Acetate 6 mg|Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.
11125219|NCT01728454|FG002|Participant Flow|Telapristone Acetate 12 mg|Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
11125220|NCT01728454|OG000|Outcome|Placebo|Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.
11125221|NCT01728454|OG001|Outcome|Telapristone Acetate 6 mg|Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.
11125222|NCT01728454|OG002|Outcome|Telapristone Acetate 12 mg|Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
11125223|NCT01728454|EG000|Reported Event|Placebo (Stage 2)|Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.
11125224|NCT01728454|EG001|Reported Event|Telapristone Acetate 6 mg (Stage 2)|Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.
11125225|NCT01728454|EG002|Reported Event|Telapristone Acetate 12 mg (Stage 2)|Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
11125226|NCT01728454|EG003|Reported Event|Placebo:Telapristone Acetate 12 mg (Stage 3)|Eligible participants who received placebo in Stage 2 and opted to receive up to 2 additional 16-week cycles of telapristone acetate (Proellex®) 12 mg/day in Stage 3.
11125227|NCT01728454|EG004|Reported Event|Telapristone Acetate 6 mg (Stage 3)|Eligible participants who received telapristone acetate 6 mg in Stage 2 and opted to receive up to 2 additional 16-week cycles of telapristone acetate (Proellex®) 6 mg/day in Stage 3.
11125228|NCT01728454|EG005|Reported Event|Telapristone Acetate 12 mg (Stage 3)|Eligible participants who received telapristone acetate 12 mg in Stage 2 and opted to receive 2 additional 16-week cycles of telapristone acetate (Proellex®) 12 mg/day in Stage 3.
11125229|NCT01728584|BG000|Baseline|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
11125230|NCT01728584|BG001|Baseline|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
11125231|NCT01728584|BG002|Baseline|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
11125232|NCT01728584|BG003|Baseline|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
11125233|NCT01728584|BG004|Baseline|Total|Total of all reporting groups
11125234|NCT01728584|FG000|Participant Flow|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
11125235|NCT01728584|FG001|Participant Flow|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
11125236|NCT01728584|FG002|Participant Flow|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts [PTCs])/Standard insufflation pressure (starting pressure of 12 mmHg).
11125237|NCT01728584|FG003|Participant Flow|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
11125238|NCT01728584|OG000|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
11125239|NCT01728584|OG001|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
11125240|NCT01728584|OG002|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
11125241|NCT01728584|OG003|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
11125242|NCT01728584|OG000|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
10845271|NCT00266032|OG002|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
10848777|NCT00291447|EG001|Reported Event|Cohort 2|"Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11125243|NCT01728584|OG001|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
11125244|NCT01728584|OG002|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
11125245|NCT01728584|OG003|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
11125246|NCT01728584|EG000|Reported Event|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
11125247|NCT01728584|EG001|Reported Event|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
11125248|NCT01728584|EG002|Reported Event|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
11125249|NCT01728584|EG003|Reported Event|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
11125250|NCT01728623|BG000|Baseline|Lenvatinib (Arm 1)|Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 1 included participants with DTC.
11125251|NCT01728623|BG001|Baseline|Lenvatinib (Arm 2)|Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
11125252|NCT01728623|BG002|Baseline|Lenvatinib (Arm 3)|Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
11125253|NCT01728623|BG003|Baseline|Total|Total of all reporting groups
11125254|NCT01728623|FG000|Participant Flow|Arm 4: Lenvatinib (MTC, DTC, ATC)|Participants received 24 milligram (mg) lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (differentiated thyroid cancer [DTC], medullary thyroid cancer [MTC], and anaplastic thyroid cancer [ATC]).
11125255|NCT01728623|OG000|Outcome|Arm 4: Lenvatinib (DTC, MTC, ATC)|Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
11125256|NCT01728623|OG000|Outcome|Lenvatinib (Arm 1)|Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 1 included participants with DTC.
11125257|NCT01728623|OG001|Outcome|Lenvatinib (Arm 2)|Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
11125258|NCT01728623|OG002|Outcome|Lenvatinib (Arm 3)|Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
11125259|NCT01728623|EG000|Reported Event|Arm 4: Lenvatinib (DTC, MTC, ATC)|Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
11125260|NCT01728636|BG000|Baseline|Tranexamic Acid|"Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period~Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure"
11125261|NCT01728636|BG001|Baseline|Placebo|"Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course~Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure"
11125262|NCT01728636|BG002|Baseline|Total|Total of all reporting groups
11125263|NCT01728636|FG000|Participant Flow|Tranexamic Acid|"Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period~Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure"
11125264|NCT01728636|FG001|Participant Flow|Placebo|"Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course~Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure"
11125265|NCT01728636|OG000|Outcome|Tranexamic Acid|"Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period~Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure"
11125266|NCT01728636|OG001|Outcome|Placebo|"Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course~Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure"
11125267|NCT01728636|EG000|Reported Event|Tranexamic Acid|"Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period~Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure"
11125268|NCT01728636|EG001|Reported Event|Placebo|"Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course~Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure"
11125269|NCT01728779|BG000|Baseline|Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)|"Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.~Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days.~Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered"
11125270|NCT01728779|FG000|Participant Flow|Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)|"Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.~Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days.~Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered"
10878775|NCT00454207|FG001|Participant Flow|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
10878776|NCT00454207|OG000|Outcome|Sildenafil: Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878777|NCT00454207|OG000|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878778|NCT00454207|OG000|Outcome|Sildenafil:Part I , Functional Class at Baseline: I|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were I. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878779|NCT00454207|OG001|Outcome|Sildenafil:Part I, Functional Class at Baseline: II|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
11126890|NCT01736241|BG003|Baseline|50 mg LY3053102|LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
10878780|NCT00454207|OG002|Outcome|Sildenafil, Part I, Functional Class at Baseline: III|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878781|NCT00454207|OG003|Outcome|Sildenafil, Part I, Functional Class at Baseline:IV|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878782|NCT00454207|OG000|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
11006776|NCT01087918|EG000|Reported Event|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
11006777|NCT01087918|EG001|Reported Event|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
11006778|NCT01087931|BG000|Baseline|Bupivacaine|"This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site.~Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site."
11006779|NCT01087931|BG001|Baseline|Saline|"This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site.~Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site."
11006780|NCT01087931|BG002|Baseline|Total|Total of all reporting groups
11006781|NCT01087931|FG000|Participant Flow|Bupivacaine|"This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site.~Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site."
11006782|NCT01087931|FG001|Participant Flow|Saline|"This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site.~Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site."
11006783|NCT01087931|OG000|Outcome|Bupivacaine|"This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site.~Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site."
11006784|NCT01087931|OG001|Outcome|Saline|"This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site.~Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site."
11006785|NCT01087931|EG000|Reported Event|Bupivacaine|"This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site.~Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site."
11006786|NCT01087931|EG001|Reported Event|Saline|"This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site.~Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site."
11125271|NCT01728779|OG000|Outcome|Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)|"Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.~Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days.~Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered"
11125272|NCT01728779|EG000|Reported Event|Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)|"Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.~Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days.~Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered"
11125273|NCT01728792|BG000|Baseline|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
11125274|NCT01728792|BG001|Baseline|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
11125275|NCT01728792|BG002|Baseline|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
11125276|NCT01728792|BG003|Baseline|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
11125277|NCT01728792|BG004|Baseline|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
11125278|NCT01728792|BG005|Baseline|Total|Total of all reporting groups
11125279|NCT01728792|FG000|Participant Flow|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
11125280|NCT01728792|FG001|Participant Flow|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
11125281|NCT01728792|FG002|Participant Flow|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
11125282|NCT01728792|FG003|Participant Flow|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
11125283|NCT01728792|FG004|Participant Flow|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
11125284|NCT01728792|OG000|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
11125285|NCT01728792|OG001|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
11125286|NCT01728792|OG002|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
11125287|NCT01728792|OG003|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
11125288|NCT01728792|OG004|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
11125289|NCT01728792|EG000|Reported Event|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
11125290|NCT01728792|EG001|Reported Event|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
11125291|NCT01728792|EG002|Reported Event|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
11125292|NCT01728792|EG003|Reported Event|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
11125293|NCT01728792|EG004|Reported Event|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
10848778|NCT00291447|EG002|Reported Event|Cohort 3|"Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11125294|NCT01728805|BG000|Baseline|KW-0761|"anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)~KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression"
11125295|NCT01728805|BG001|Baseline|Vorinostat|"vorinostat 400 mg once daily~Vorinostat"
11125296|NCT01728805|BG002|Baseline|Total|Total of all reporting groups
11125297|NCT01728805|FG000|Participant Flow|KW-0761|"anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)~KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression"
11125298|NCT01728805|FG001|Participant Flow|Vorinostat|"vorinostat 400 mg once daily~Vorinostat"
11125299|NCT01728805|FG002|Participant Flow|Vorinostat Original Then Crossover to KW-0761|Subjects who were randomized to vorinostat could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
11125300|NCT01728805|OG000|Outcome|KW-0761|"anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)~KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression"
11125301|NCT01728805|OG001|Outcome|Vorinostat|"vorinostat 400 mg once daily~Vorinostat"
11125302|NCT01728805|EG000|Reported Event|KW-0761|"anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)~KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression"
11125303|NCT01728805|EG001|Reported Event|Vorinostat|"vorinostat 400 mg once daily~Vorinostat"
11125304|NCT01728805|EG002|Reported Event|Vorinostat Original Then Crossover to KW-0761|Subjects who were randomized to vorinostat could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
11125305|NCT01728844|BG000|Baseline|Beta-tricalcium Phosphate Alone|beta-tricalcium phosphate + placebo vehicle
11006787|NCT01087944|BG000|Baseline|Overall|Participants received PEG-IFN alfa-2a 180 mcg SC once a week either AI or PFS for the first 3 weeks and then switched to the other method of injection for an additional 3 weeks. Participants also received ribavirin according to standard of care per the investigator's judgment.
11006788|NCT01087944|FG000|Participant Flow|Sequence 1 (Auto-Injector Then Pre-filled Syringe)|Participants received Peginterferon alfa-2a (PEG-IFN) 180 microgram (mcg) /0.5 milliliter (mL) subcutaneously once a week using autoinjector from Week 1-3 in Treatment Period 1 and using pre-filled syringe from Week 4-6 in Treatment Period 2.
11006789|NCT01087944|FG001|Participant Flow|Sequence 2 (Pre-filled Syringe Then Auto-Injector)|Participants received PEG-IFN 180 mcg /0.5 mL subcutaneously once a week using pre-filled syringe from Week 1-3 in Treatment Period 1 and using autoinjector from Week 4-6 in Treatment Period 2.
11006790|NCT01087944|OG000|Outcome|Autoinjector|The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
11006791|NCT01087944|OG001|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
11006792|NCT01087944|EG000|Reported Event|Autoinjector|The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
11006793|NCT01087944|EG001|Reported Event|Pre-filled Syringe|The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
11006794|NCT01087957|BG000|Baseline|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
11006795|NCT01087957|BG001|Baseline|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
11006796|NCT01087957|BG002|Baseline|Total|Total of all reporting groups
11006797|NCT01087957|FG000|Participant Flow|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
11006798|NCT01087957|FG001|Participant Flow|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
11006799|NCT01087957|OG000|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
11006800|NCT01087957|OG001|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
11006801|NCT01087957|EG000|Reported Event|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
11006802|NCT01087957|EG001|Reported Event|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
11006803|NCT01087970|BG000|Baseline|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
11006804|NCT01087970|FG000|Participant Flow|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
11006805|NCT01087970|OG000|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
11006806|NCT01087970|EG000|Reported Event|Cetuximab + Pemetrexed + Carboplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
11125306|NCT01728844|BG001|Baseline|GFeBGS 0.1%|GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
11006807|NCT01087970|EG001|Reported Event|Cetuximab + Pemetrexed + Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
11006808|NCT01087996|BG000|Baseline|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
11006809|NCT01087996|BG001|Baseline|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
11006810|NCT01087996|BG002|Baseline|Total|Total of all reporting groups
11006811|NCT01087996|FG000|Participant Flow|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
11006812|NCT01087996|FG001|Participant Flow|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
11006813|NCT01087996|OG000|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
11006814|NCT01087996|OG001|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
11006815|NCT01087996|EG000|Reported Event|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
11006816|NCT01087996|EG001|Reported Event|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
11006817|NCT01088048|BG000|Baseline|Idelalisib + Rituximab|"Participants with CLL and iNHL received treatments as follows:~Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2~Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2"
11125307|NCT01728844|BG002|Baseline|GFeBGS 0.3%|GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
11125308|NCT01728844|BG003|Baseline|GFeGBS 0.4%|GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
11125309|NCT01728844|BG004|Baseline|Total|Total of all reporting groups
11125310|NCT01728844|FG000|Participant Flow|Beta-tricalcium Phosphate Alone|beta-tricalcium phosphate + placebo vehicle
11125311|NCT01728844|FG001|Participant Flow|GFeBGS 0.1%|GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
11125312|NCT01728844|FG002|Participant Flow|GFeBGS 0.3%|GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
11125313|NCT01728844|FG003|Participant Flow|GFeGBS 0.4%|GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
11125314|NCT01728844|OG000|Outcome|Beta-tricalcium Phosphate Alone|beta-tricalcium phosphate + placebo vehicle
11125315|NCT01728844|OG001|Outcome|GFeBGS 0.1%|GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
11125316|NCT01728844|OG002|Outcome|GFeBGS 0.3%|GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
11125317|NCT01728844|OG003|Outcome|GFeGBS 0.4%|GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
11125318|NCT01728844|EG000|Reported Event|Beta-tricalcium Phosphate Alone|beta-tricalcium phosphate + placebo vehicle
11125319|NCT01728844|EG001|Reported Event|GFeBGS 0.1%|GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
11125320|NCT01728844|EG002|Reported Event|GFeBGS 0.3%|GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
11125321|NCT01728844|EG003|Reported Event|GFeGBS 0.4%|GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
11125322|NCT01729026|BG000|Baseline|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
11125323|NCT01729026|BG001|Baseline|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
11125324|NCT01729026|BG002|Baseline|Total|Total of all reporting groups
11125325|NCT01729026|FG000|Participant Flow|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
11125326|NCT01729026|FG001|Participant Flow|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
11125327|NCT01729026|OG000|Outcome|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
11125328|NCT01729026|OG001|Outcome|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
11125329|NCT01729026|OG000|Outcome|Shelter Dog Adoption|Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
11125330|NCT01729026|OG000|Outcome|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a San Antonio Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog.~Following adoption, Veterans and their dogs will receive 8 weeks of free obedience training provided by a veterinarian,"
11126891|NCT01736241|BG004|Baseline|150 mg LY3053102|LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
11006818|NCT01088048|BG001|Baseline|Idelalisib + Bendamustine|"Participants with CLL and iNHL received treatments as follows:~Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006819|NCT01088048|BG002|Baseline|Idelalisib + Everolimus|"Participants with MCL received treatments as follows:~Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle"
11006820|NCT01088048|BG003|Baseline|Idelalisib + Bortezomib|"Participants with MCL received treatments as follows:~Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle"
11006821|NCT01088048|BG004|Baseline|Idelalisib + Rituximab + Bendamustine|"Participants with CLL, iNHL and MCL received treatments as follows:~Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6~Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006822|NCT01088048|BG005|Baseline|Idelalisib + Ofatumumab|"Participants with CLL received treatments as follows:~Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))"
11006823|NCT01088048|BG006|Baseline|Idelalisib + Fludarabine|"Participants with CLL received treatments as follows:~Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6"
11006824|NCT01088048|BG007|Baseline|Idelalisib + Chlorambucil|"Participants with CLL received treatments as follows:~Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11006825|NCT01088048|BG008|Baseline|Idelalisib + Rituximab + Chlorambucil|"Participants with CLL received treatments as follows:~Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11006826|NCT01088048|BG009|Baseline|Idelalisib + Rituximab + Lenalidomide|"Participants with CLL and iNHL received treatments as follows:~Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles"
11006827|NCT01088048|BG010|Baseline|Total|Total of all reporting groups
11006828|NCT01088048|FG000|Participant Flow|Idelalisib + Rituximab|"Participants with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (iNHL) received treatments as follows:~Cohort 1a: Idelalisib (IDELA) 100 mg orally twice daily (BID) on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 intravenously (IV) on Days 1, 8, 15 & 22, Cycles 1 & 2~Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2"
11006829|NCT01088048|FG001|Participant Flow|Idelalisib + Bendamustine|"Participants with CLL and iNHL received treatments as follows:~Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006830|NCT01088048|FG002|Participant Flow|Idelalisib + Everolimus|"Participants with mantle cell lymphoma (MCL) received treatments as follows:~Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle"
11006831|NCT01088048|FG003|Participant Flow|Idelalisib + Bortezomib|"Participants with MCL received treatments as follows:~Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle"
11126892|NCT01736241|BG005|Baseline|405 mg LY3053102|LY3053102: A single dose of 405 mg, administered subcutaneously.
11126893|NCT01736241|BG006|Baseline|Placebo|Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort.
11125331|NCT01729026|OG001|Outcome|Wait-list, Then Adoption After 3 Months|After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a San Antonio Humane Society adoption counselor and study staff and take it home to live with them The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive 8 weeks of free obedience training by a veterinarian.
11125332|NCT01729026|EG000|Reported Event|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
11125333|NCT01729026|EG001|Reported Event|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
11125334|NCT01729039|BG000|Baseline|Gaze Stability (GS)|"Gaze Stability group intervention includes standard balance rehabilitation plus vestibular-specific exercises.~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Vestibular-specific exercises: Gaze stability exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target."
11125335|NCT01729039|BG001|Baseline|Control (CON)|"Control group intervention includes standard balance rehabilitation plus placebo eye exercises.~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Control exercises: Placebo eye exercises consist of saccadic eye movements while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation."
11125336|NCT01729039|BG002|Baseline|Total|Total of all reporting groups
11125337|NCT01729039|FG000|Participant Flow|Gaze Stability|"Standard balance rehabilitation plus Vestibular-specific exercises~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Vestibular-specific exercises: Gaze stability exercises are performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target."
11125338|NCT01729039|FG001|Participant Flow|Control|"Standard balance rehabilitation plus Placebo eye exercises~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Control: Placebo exercises consist of saccadic eye movements while the head is stationary and are performed by the control group (CON). These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation."
11125339|NCT01729039|OG000|Outcome|Gaze Stability|"Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target."
11126894|NCT01736241|BG007|Baseline|Total|Total of all reporting groups
10846086|NCT00272961|OG004|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
11125340|NCT01729039|OG001|Outcome|Control|"Control group (CON) intervention includes standard balance rehabilitation plus placebo eye exercises.~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation."
11125341|NCT01729039|OG000|Outcome|Gaze Stability|"Standard balance rehabilitation plus Vestibular-specific exercises~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Vestibular-specific exercises: Gaze stability exercises are performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target."
11125342|NCT01729039|OG001|Outcome|Control|"Standard balance rehabilitation plus Placebo eye exercises~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Control: Placebo exercises consist of saccadic eye movements while the head is stationary and are performed by the control group (CON). These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation."
11125343|NCT01729039|OG001|Outcome|Control|"Control (CON) group intervention includes standard balance rehabilitation plus placebo eye exercises.~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation."
11125344|NCT01729039|EG000|Reported Event|Gaze Stability|"Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target."
11125345|NCT01729039|EG001|Reported Event|Control|"Control group (CON intervention includes standard balance rehabilitation plus placebo eye exercises.~Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.~Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation."
11125346|NCT01729156|BG000|Baseline|Healthy Controls|"Healthy controls receiving 1000 mg metformin twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
11125347|NCT01729156|BG001|Baseline|Placebo|"Placebo~Placebo: 2 tablets twice daily in 3 months"
11125348|NCT01729156|BG002|Baseline|Metformin|"Metformin Teva, 1000 mg twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
10846087|NCT00272961|EG000|Reported Event|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
11125349|NCT01729156|BG003|Baseline|Total|Total of all reporting groups
11125350|NCT01729156|FG000|Participant Flow|Healthy Controls|"Healthy controls receiving 1000 mg metformin twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
11125351|NCT01729156|FG001|Participant Flow|Placebo|"Placebo~Placebo: 2 tablets twice daily in 3 months"
11125352|NCT01729156|FG002|Participant Flow|Metformin|"Metformin Teva, 1000 mg twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
11125353|NCT01729156|OG000|Outcome|Healthy Controls|"Healthy controls receiving 1000 mg metformin twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
11125354|NCT01729156|OG001|Outcome|Placebo|"Placebo~Placebo: 2 tablets twice daily in 3 months"
11125355|NCT01729156|OG002|Outcome|Metformin|"Metformin Teva, 1000 mg twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
11125356|NCT01729156|OG002|Outcome|Metformin|"Metformin Sandoz, 1000 mg twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
11125357|NCT01729156|EG000|Reported Event|Healthy Controls|"Healthy controls receiving 1000 mg metformin twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
11125358|NCT01729156|EG001|Reported Event|Placebo|"Placebo~Placebo: 2 tablets twice daily in 3 months"
11125359|NCT01729156|EG002|Reported Event|Metformin|"Metformin Teva, 1000 mg twice daily for 3 months~Metformin: 1000 mg metformin twice daily in 3 months"
11125360|NCT01729208|BG000|Baseline|Dual Focus Soft Contact Lens|"Dual Focus Soft Contact Lens~Dual Focus Soft Contact Lens"
11125361|NCT01729208|BG001|Baseline|Single Vision Soft Contact Lens|"Single Vision Soft Contact Lens~Single Vision Soft Contact Lens"
11125362|NCT01729208|BG002|Baseline|Total|Total of all reporting groups
11125363|NCT01729208|FG000|Participant Flow|Dual Focus Soft Contact Lens|"Dual Focus Soft Contact Lens~Dual Focus Soft Contact Lens"
11125364|NCT01729208|FG001|Participant Flow|Single Vision Soft Contact Lens|"Single Vision Soft Contact Lens~Single Vision Soft Contact Lens"
11125365|NCT01729208|OG000|Outcome|Dual Focus Soft Contact Lens|"Dual Focus Soft Contact Lens~Dual Focus Soft Contact Lens"
11125366|NCT01729208|OG001|Outcome|Single Vision Soft Contact Lens|"Single Vision Soft Contact Lens~Single Vision Soft Contact Lens"
11125367|NCT01729208|EG000|Reported Event|Dual Focus Soft Contact Lens|"Dual Focus Soft Contact Lens~Dual Focus Soft Contact Lens"
11125368|NCT01729208|EG001|Reported Event|Single Vision Soft Contact Lens|"Single Vision Soft Contact Lens~Single Vision Soft Contact Lens"
11125369|NCT01729247|BG000|Baseline|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
11125370|NCT01729247|FG000|Participant Flow|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
11125371|NCT01729247|OG000|Outcome|Low ACT Score|Participants who had an asthma control test (ACT) score of <=19, which indicates less well-controlled asthma
11125372|NCT01729247|OG001|Outcome|High ACT Score|Participants who had an asthma control test (ACT) score of >19, which indicates well-controlled asthma
11125373|NCT01729247|OG000|Outcome|ICS Use|Participants that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
11125374|NCT01729247|OG001|Outcome|No ICS Use|Participants that did not use inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
11125375|NCT01729247|OG000|Outcome|Low Airway Inflammation|As categorized by physician assessment
11125376|NCT01729247|OG001|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
11125377|NCT01729247|OG002|Outcome|High Airway Inflammation|As categorized by physician assessment
11125378|NCT01729247|OG000|Outcome|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
11125379|NCT01729247|EG000|Reported Event|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
11125380|NCT01729338|BG000|Baseline|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
11125381|NCT01729338|FG000|Participant Flow|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
11125382|NCT01729338|OG000|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
11126895|NCT01736241|FG000|Participant Flow|2 mg LY3053102|LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
11126896|NCT01736241|FG001|Participant Flow|7 mg LY3053102|LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
11125383|NCT01729338|EG000|Reported Event|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
11125384|NCT01729494|BG000|Baseline|Group A|"Alemtuzumab + belatacept + mycophenolate mofetil /Enteric coated mycophenolate sodium + early cessation of steroids~Alemtuzumab: Alemtuzumab will be dosed on day of transplant (Study Day 1) at dose of 30 mg given intravenously (IV) over a period of 2 hours after induction of anesthesia. Methylprednisolone IV will be administered 30-60 minutes prior to the administration of alemtuzumab.~Belatacept: Belatacept will be administered via intravenous (IV) infusion according to the FDA approved dosage recommendations. Subjects randomized to belatacept arms will receive the first dose of IV belatacept (10 mg/kg) within 12-24 hours post reperfusion. The second dose will be given between post-transplant days 4 -6 (Study Days 5-7), and then study days 14, 28, 56, and 84 (12 weeks) and then subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial at 24 months (104 weeks). Study Day 1 is the day of transplant."
11125385|NCT01729494|BG001|Baseline|Group B|"Rabbit antithymocyte globulin + belatacept + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids~rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.~Belatacept: Belatacept is administered via intravenous (IV) infusion according to the FDA label"
11125386|NCT01729494|BG002|Baseline|Group C|"Rabbit antithymocyte globulin + tacrolimus + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids~rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.~Tacrolimus: Tacrolimus will be administered orally twice daily (BID)."
11125387|NCT01729494|BG003|Baseline|Total|Total of all reporting groups
11125388|NCT01729494|FG000|Participant Flow|Group A|"Alemtuzumab + belatacept + mycophenolate mofetil /Enteric coated mycophenolate sodium + early cessation of steroids~Alemtuzumab: Alemtuzumab will be dosed on day of transplant (Study Day 1) at dose of 30 mg given intravenously (IV) over a period of 2 hours after induction of anesthesia. Methylprednisolone IV will be administered 30-60 minutes prior to the administration of alemtuzumab.~Belatacept: Belatacept will be administered via intravenous (IV) infusion according to the FDA approved dosage recommendations. Subjects randomized to belatacept arms will receive the first dose of IV belatacept (10 mg/kg) within 12-24 hours post reperfusion. The second dose will be given between post-transplant days 4 -6 (Study Days 5-7), and then study days 14, 28, 56, and 84 (12 weeks) and then subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial at 24 months (104 weeks). Study Day 1 is the day of transplant."
11125389|NCT01729494|FG001|Participant Flow|Group B|"Rabbit antithymocyte globulin + belatacept + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids~rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.~Belatacept: Belatacept is administered via intravenous (IV) infusion according to the FDA label."
11126897|NCT01736241|FG002|Participant Flow|20 mg LY3053102|LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
11126898|NCT01736241|FG003|Participant Flow|50 mg LY3053102|LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
11126899|NCT01736241|FG004|Participant Flow|150 mg LY3053102|LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
10846088|NCT00272961|EG001|Reported Event|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
10846089|NCT00272961|EG002|Reported Event|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
11125390|NCT01729494|FG002|Participant Flow|Group C|"Rabbit antithymocyte globulin + tacrolimus + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids~rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.~Tacrolimus: Tacrolimus will be administered orally twice daily (BID)."
11125391|NCT01729494|OG000|Outcome|Group A|"Alemtuzumab + belatacept + mycophenolate mofetil /Enteric coated mycophenolate sodium + early cessation of steroids~Alemtuzumab: Alemtuzumab will be dosed on day of transplant (Study Day 1) at dose of 30 mg given intravenously (IV) over a period of 2 hours after induction of anesthesia. Methylprednisolone IV will be administered 30-60 minutes prior to the administration of alemtuzumab.~Belatacept: Belatacept will be administered via intravenous (IV) infusion according to the FDA approved dosage recommendations. Subjects randomized to belatacept arms will receive the first dose of IV belatacept (10 mg/kg) within 12-24 hours post reperfusion. The second dose will be given between post-transplant days 4 -6 (Study Days 5-7), and then study days 14, 28, 56, and 84 (12 weeks) and then subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial at 24 months (104 weeks). Study Day 1 is the day of transplant."
11125392|NCT01729494|OG001|Outcome|Group B|"Rabbit antithymocyte globulin + belatacept + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids~rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.~Belatacept: Belatacept is administered via intravenous (IV) infusion according to the FDA label"
11125393|NCT01729494|OG002|Outcome|Group C|"Rabbit antithymocyte globulin + tacrolimus + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids~rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.~Tacrolimus: Tacrolimus will be administered orally twice daily (BID)."
11125394|NCT01729494|EG000|Reported Event|Group A|"Alemtuzumab + belatacept + mycophenolate mofetil /Enteric coated mycophenolate sodium + early cessation of steroids~Alemtuzumab: Alemtuzumab will be dosed on day of transplant (Study Day 1) at dose of 30 mg given intravenously (IV) over a period of 2 hours after induction of anesthesia. Methylprednisolone IV will be administered 30-60 minutes prior to the administration of alemtuzumab.~Belatacept: Belatacept will be administered via intravenous (IV) infusion according to the FDA approved dosage recommendations. Subjects randomized to belatacept arms will receive the first dose of IV belatacept (10 mg/kg) within 12-24 hours post reperfusion. The second dose will be given between post-transplant days 4 -6 (Study Days 5-7), and then study days 14, 28, 56, and 84 (12 weeks) and then subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial at 24 months (104 weeks). Study Day 1 is the day of transplant."
11125395|NCT01729494|EG001|Reported Event|Group B|"Rabbit antithymocyte globulin + belatacept + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids~rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.~Belatacept: Belatacept is administered via intravenous (IV) infusion according to the FDA label"
11125396|NCT01729494|EG002|Reported Event|Group C|"Rabbit antithymocyte globulin + tacrolimus + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids~rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.~Tacrolimus: Tacrolimus will be administered orally twice daily (BID)."
11125397|NCT01729559|BG000|Baseline|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
11126900|NCT01736241|FG005|Participant Flow|405 mg LY3053102|LY3053102: A single dose of 405 mg, administered subcutaneously.
11125398|NCT01729559|BG001|Baseline|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
11125399|NCT01729559|BG002|Baseline|Total|Total of all reporting groups
11125400|NCT01729559|FG000|Participant Flow|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
11125401|NCT01729559|FG001|Participant Flow|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
11125402|NCT01729559|OG000|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
11125403|NCT01729559|OG001|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
11125404|NCT01729559|EG000|Reported Event|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
11125405|NCT01729559|EG001|Reported Event|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
11125406|NCT01729598|BG000|Baseline|Valproic Acid|"Valproic acid 250 mg or 500mg by mouth twice daily.~Valproic Acid: generic valproic acid tablets packaged in placebo-matched capsules."
11125407|NCT01729598|BG001|Baseline|Placebo|"Placebo capsule by mouth twice daily.~Placebo: Placebo capsule without active study medication in identical capsules as experimental medicine."
11125408|NCT01729598|BG002|Baseline|Total|Total of all reporting groups
11125409|NCT01729598|FG000|Participant Flow|Valproic Acid|"Valproic acid 250 mg or 500mg by mouth twice daily.~Valproic Acid: generic valproic acid tablets packaged in placebo-matched capsules."
11125410|NCT01729598|FG001|Participant Flow|Placebo|"Placebo capsule by mouth twice daily.~Placebo: Placebo capsule without active study medication in identical capsules as experimental medicine."
11125411|NCT01729598|OG000|Outcome|Valproic Acid|"Valproic acid 250 mg or 500mg by mouth twice daily.~Valproic Acid: generic valproic acid tablets packaged in placebo-matched capsules."
11125412|NCT01729598|OG001|Outcome|Placebo|"Placebo capsule by mouth twice daily.~Placebo: Placebo capsule without active study medication in identical capsules as experimental medicine."
11125413|NCT01729598|EG000|Reported Event|Valproic Acid|"Valproic acid 250 mg or 500mg by mouth twice daily.~Valproic Acid: generic valproic acid tablets packaged in placebo-matched capsules."
11125414|NCT01729598|EG001|Reported Event|Placebo|"Placebo capsule by mouth twice daily.~Placebo: Placebo capsule without active study medication in identical capsules as experimental medicine."
11125415|NCT01729728|BG000|Baseline|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125416|NCT01729728|BG001|Baseline|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125417|NCT01729728|BG002|Baseline|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125418|NCT01729728|BG003|Baseline|Total|Total of all reporting groups
11125419|NCT01729728|FG000|Participant Flow|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight)
11125420|NCT01729728|FG001|Participant Flow|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
11125421|NCT01729728|FG002|Participant Flow|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight)
11125422|NCT01729728|OG000|Outcome|Tapentadol Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
11125423|NCT01729728|OG000|Outcome|Visual Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125424|NCT01729728|OG000|Outcome|McGrath Color Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125425|NCT01729728|OG001|Outcome|McGrath Color Analog Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125426|NCT01729728|OG000|Outcome|Faces Pain Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
11125427|NCT01729728|OG001|Outcome|Faces Pain Scale: Young Children|Single Dose of Tapentadol Oral Solution in Children Age 3 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight). The children aged 2 were assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale and not the 6-point Faces Pain Scale - Revised.
11125428|NCT01729728|OG000|Outcome|Face, Legs, Activity, Cry, Consolability Scale|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125429|NCT01729728|OG000|Outcome|Sum of Pain Intensity Differences|"The sum of pain intensity difference over 4 hours (SPID4) were calculated as the weighted sum of the scheduled pain intensity difference collected up to 4 hours after tapentadol oral solution administration.~The time elapsed (in hours) since the previous measurement is multiplied with the pain intensity difference (PID) at the respective time, and defines the weight in the calculation of the weighted sum of pain intensity differences."
11125430|NCT01729728|OG000|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
11125431|NCT01729728|OG000|Outcome|Tapentadol Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
11125432|NCT01729728|OG000|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
11125433|NCT01729728|OG000|Outcome|Tapentadol Serum Concentrations: Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
11125434|NCT01729728|OG000|Outcome|Tapentadol-O-glucuronide Serum Concentrations Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
11125435|NCT01729728|OG000|Outcome|Tapentadol Serum Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
11125436|NCT01729728|OG000|Outcome|Tapentadol-O-glucuronide Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
11125437|NCT01729728|OG000|Outcome|Tapentadol Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125438|NCT01729728|OG000|Outcome|Respiratory Rates: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125439|NCT01729728|OG001|Outcome|Respiratory Rates: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125440|NCT01729728|OG002|Outcome|Respiratory Rates: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125441|NCT01729728|OG000|Outcome|Oxygen Saturation: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125442|NCT01729728|OG001|Outcome|Oxygen Saturation: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125443|NCT01729728|OG002|Outcome|Oxygen Saturation: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125444|NCT01729728|OG000|Outcome|Blood Pressure: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125445|NCT01729728|OG001|Outcome|Blood Pressure: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
10846090|NCT00272961|EG003|Reported Event|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
11125446|NCT01729728|OG002|Outcome|Blood Pressure: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125447|NCT01729728|OG000|Outcome|ECG Changes: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125448|NCT01729728|OG001|Outcome|ECG Changes: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125449|NCT01729728|OG002|Outcome|ECG Changes: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125450|NCT01729728|OG000|Outcome|ECG Heart Rate Change: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125451|NCT01729728|OG001|Outcome|ECG Heart Rate Change: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125452|NCT01729728|OG002|Outcome|ECG Heart Rate Change: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125453|NCT01729728|OG000|Outcome|Tapentadol Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125454|NCT01729728|OG000|Outcome|Number of TEAEs: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
11125455|NCT01729728|OG001|Outcome|Number of TEAEs: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
11125456|NCT01729728|OG002|Outcome|Number of TEAEs: Young and Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 6 years of age.
11125457|NCT01729728|OG000|Outcome|Adolescents With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125458|NCT01729728|OG001|Outcome|Older Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125459|NCT01729728|OG002|Outcome|Young and Very Young Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125460|NCT01729728|OG000|Outcome|Tapentadol Non-Compartmental PK Parameter: Tmax|Tapentadol oral solution single dose (1mg/kg body weight) of participants aged 12 years to less than 18 years old.
11125461|NCT01729728|OG000|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125462|NCT01729728|OG000|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125463|NCT01729728|OG000|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Tmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125464|NCT01729728|OG000|Outcome|Hemoglobin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125465|NCT01729728|OG001|Outcome|Hemoglobin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125466|NCT01729728|OG002|Outcome|Hemoglobin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125467|NCT01729728|OG000|Outcome|Hematocrit: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125468|NCT01729728|OG001|Outcome|Hematocrit: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125469|NCT01729728|OG002|Outcome|Hematocrit: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125470|NCT01729728|OG000|Outcome|Mean Corpuscular Volume: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125471|NCT01729728|OG001|Outcome|Mean Corpuscular Volume: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125472|NCT01729728|OG002|Outcome|Mean Corpuscular Volume: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
10848779|NCT00291447|EG003|Reported Event|Cohort 4|"Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.~ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells."
11125473|NCT01729728|OG000|Outcome|Platelet Count: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125474|NCT01729728|OG001|Outcome|Platelet Count: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125475|NCT01729728|OG002|Outcome|Platelet Count: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125476|NCT01729728|OG000|Outcome|Leukocyte Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125477|NCT01729728|OG001|Outcome|Leukocyte Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125478|NCT01729728|OG002|Outcome|Leukocyte Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125479|NCT01729728|OG000|Outcome|Blood Glucose Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125480|NCT01729728|OG001|Outcome|Blood Glucose Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125481|NCT01729728|OG002|Outcome|Blood Glucose Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125482|NCT01729728|OG000|Outcome|Blood Sodium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125483|NCT01729728|OG001|Outcome|Blood Sodium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125484|NCT01729728|OG002|Outcome|Blood Sodium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125485|NCT01729728|OG000|Outcome|Blood Potassium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125486|NCT01729728|OG001|Outcome|Blood Potassium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125487|NCT01729728|OG002|Outcome|Blood Potassium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125488|NCT01729728|OG000|Outcome|Blood Calcium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125489|NCT01729728|OG001|Outcome|Blood Calcium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125490|NCT01729728|OG002|Outcome|Blood Calcium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125491|NCT01729728|OG000|Outcome|Blood Chloride Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125492|NCT01729728|OG001|Outcome|Blood Chloride Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125493|NCT01729728|OG002|Outcome|Blood Chloride Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125494|NCT01729728|OG000|Outcome|Blood Phosphate Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125495|NCT01729728|OG001|Outcome|Blood Phosphate Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125496|NCT01729728|OG002|Outcome|Blood Phosphate Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125497|NCT01729728|OG000|Outcome|BUN Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125498|NCT01729728|OG001|Outcome|BUN Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125499|NCT01729728|OG002|Outcome|BUN Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125500|NCT01729728|OG000|Outcome|Creatinine Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125501|NCT01729728|OG001|Outcome|Creatinine Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125502|NCT01729728|OG002|Outcome|Creatinine Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125503|NCT01729728|OG000|Outcome|AST Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125504|NCT01729728|OG001|Outcome|AST Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125505|NCT01729728|OG002|Outcome|AST Activity: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125506|NCT01729728|OG000|Outcome|Triglycerides Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125507|NCT01729728|OG001|Outcome|Triglycerides Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125508|NCT01729728|OG002|Outcome|Triglycerides Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125509|NCT01729728|OG000|Outcome|Albumin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125510|NCT01729728|OG001|Outcome|Albumin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125511|NCT01729728|OG002|Outcome|Albumin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125512|NCT01729728|OG000|Outcome|Urate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125513|NCT01729728|OG001|Outcome|Urate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125514|NCT01729728|OG002|Outcome|Urate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125515|NCT01729728|OG000|Outcome|Glomerular Filtration Rate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125516|NCT01729728|OG001|Outcome|Glomerular Filtration Rate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125517|NCT01729728|OG002|Outcome|Glomerular Filtration Rate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125518|NCT01729728|OG000|Outcome|Specific Gravity Urine: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125519|NCT01729728|OG001|Outcome|Specific Gravity Urine: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
10848780|NCT00291499|BG000|Baseline|Chondroitin 4&6 Sulfate (Condrosulf)|Chondroitin 4&6 sulfate (Condrosulf): 800 mg/day for 6 months
11125520|NCT01729728|OG002|Outcome|Specific Gravity Urine: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125521|NCT01729728|OG000|Outcome|Urine pH: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125522|NCT01729728|OG001|Outcome|Urine pH: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125523|NCT01729728|OG002|Outcome|Urine pH: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125524|NCT01729728|OG000|Outcome|ALT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125525|NCT01729728|OG001|Outcome|ALT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125526|NCT01729728|OG002|Outcome|ALT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125527|NCT01729728|OG000|Outcome|GGT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125528|NCT01729728|OG001|Outcome|GGT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125529|NCT01729728|OG002|Outcome|GGT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125530|NCT01729728|OG000|Outcome|Bilirubin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125531|NCT01729728|OG001|Outcome|Bilirubin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125532|NCT01729728|OG002|Outcome|Bilirubin Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125533|NCT01729728|OG000|Outcome|LDH Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
10845272|NCT00266032|EG000|Reported Event|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
11125534|NCT01729728|OG001|Outcome|LDH Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125535|NCT01729728|OG002|Outcome|LDH Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125536|NCT01729728|OG000|Outcome|Protein Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125537|NCT01729728|OG001|Outcome|Protein Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125538|NCT01729728|OG002|Outcome|Protein Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125539|NCT01729728|OG000|Outcome|CK Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125540|NCT01729728|OG001|Outcome|CK Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125541|NCT01729728|OG002|Outcome|CK Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125542|NCT01729728|OG000|Outcome|ALP Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125543|NCT01729728|OG001|Outcome|ALP Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125544|NCT01729728|OG002|Outcome|ALP Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125545|NCT01729728|OG000|Outcome|TL Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125546|NCT01729728|OG001|Outcome|TL Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125547|NCT01729728|OG002|Outcome|TL Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125548|NCT01729728|EG000|Reported Event|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125549|NCT01729728|EG001|Reported Event|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125550|NCT01729728|EG002|Reported Event|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
11125551|NCT01729819|BG000|Baseline|Combination|"Tolterodine tartrate extended release capsules (4 mg) + Desmopressin orally disintegrating tablets (25 µg)~Tolterodine tartrate extended release capsules~Desmopressin orally disintegrating tablets"
11125552|NCT01729819|BG001|Baseline|Tolterodine|"Tolterodine tartrate extended release capsules (4 mg)+ Placebo orally disintegrating tablets~Tolterodine tartrate extended release capsules~Placebo orally disintegrating tablets"
11125553|NCT01729819|BG002|Baseline|Total|Total of all reporting groups
11125554|NCT01729819|FG000|Participant Flow|Combination|"Tolterodine tartrate extended release capsules (4 mg) + Desmopressin orally disintegrating tablets (25 μg)~Tolterodine tartrate extended release capsules~Desmopressin orally disintegrating tablets"
11125555|NCT01729819|FG001|Participant Flow|Tolterodine|"Tolterodine tartrate extended release capsules (4 mg) + Placebo orally disintegrating tablets~Tolterodine tartrate extended release capsules~Placebo orally disintegrating tablets"
11125556|NCT01729819|OG000|Outcome|Combination|"Tolterodine tartrate extended release capsules (4 mg)+ Desmopressin orally disintegrating tablets (25 μg)~Tolterodine tartrate extended release capsules~Desmopressin orally disintegrating tablets"
11125557|NCT01729819|OG001|Outcome|Tolterodine|"Tolterodine tartrate extended release capsules (4 mg) + Placebo orally disintegrating tablets~Tolterodine tartrate extended release capsules~Placebo orally disintegrating tablets"
11125558|NCT01729819|OG000|Outcome|Combination|"Tolterodine tartrate extended release capsules (4 mg) + Desmopressin orally disintegrating tablets (25 μg)~Tolterodine tartrate extended release capsules~Desmopressin orally disintegrating tablets"
11125559|NCT01729819|OG000|Outcome|Combination|"Tolterodine tartrate extended release capsules (4 mg) + Desmopressin orally disintegrating tablets (25 µg)~Tolterodine tartrate extended release capsules~Desmopressin orally disintegrating tablets"
11125560|NCT01729819|OG000|Outcome|Treatment Difference (Combination-tolterodine)|Change in mean number of nocturnal voids between combination (desmopressin [25 µg] + tolterodine [4 mg]) and tolterodine (4 mg) was estimated at month 1, month 2, month 3 and overall during the three months
11125561|NCT01729819|EG000|Reported Event|Combination|"Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets~Tolterodine tartrate extended release capsules~Desmopressin orally disintegrating tablets"
11125562|NCT01729819|EG001|Reported Event|Tolterodine|"Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets~Tolterodine tartrate extended release capsules~Placebo orally disintegrating tablets"
11125563|NCT01729845|BG000|Baseline|Dose Level 1: 5-Days of Decitabine-MEC|"Patients receive decitabine IV days -9 to -5 (dose level 1).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11125564|NCT01729845|BG001|Baseline|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11125565|NCT01729845|BG002|Baseline|Dose Level 3: 10-Days of Decitabine-MEC|"Patients receive decitabine IV days -14 to -5 (dose level 3).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11125566|NCT01729845|BG003|Baseline|Total|Total of all reporting groups
11125567|NCT01729845|FG000|Participant Flow|Dose Level 1: 5-Days of Decitabine-MEC|"Patients receive decitabine IV days -9 to -5 (dose level 1).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Mitoxantrone Hydrochloride: Given IV"
11125568|NCT01729845|FG001|Participant Flow|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Mitoxantrone Hydrochloride: Given IV"
11125569|NCT01729845|FG002|Participant Flow|Dose Level 3: 10-days of Decitabine-MEC|"Patients receive decitabine IV days -14 to -5 (dose level 3).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV"
11125570|NCT01729845|OG000|Outcome|Dose Level 1: 5-Days of Decitabine-MEC|"Patients receive decitabine IV days -9 to -5 (dose level 1). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV~Decitabine: Given IV~Etoposide: Given IV~Mitoxantrone Hydrochloride: Given IV"
11126901|NCT01736241|FG006|Participant Flow|Placebo|Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort.
11126902|NCT01736241|OG000|Outcome|2 mg LY3053102|LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously.
11125571|NCT01729845|OG001|Outcome|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV"
11125572|NCT01729845|OG002|Outcome|Dose Level 3: 10-Days of Decitabine-MEC|"Patients receive decitabine IV days -14 to -5 (dose level 1).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV"
11125573|NCT01729845|OG000|Outcome|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV"
11125574|NCT01729845|OG000|Outcome|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV on days -11 to -5 (dose level 2)~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Mitoxantrone Hydrochloride: Given IV"
11125575|NCT01729845|EG000|Reported Event|Dose Level 1: 5-Days of Decitabine-MEC|"Patients receive decitabine IV days -9 to -5 (dose level 1).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV"
11125576|NCT01729845|EG001|Reported Event|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV"
11125577|NCT01729845|EG002|Reported Event|Dose Level 3: 10-days of Decitabine-MEC|"Patients receive decitabine IV days -14 to -5 (dose level 3).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV"
11125578|NCT01729871|BG000|Baseline|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
11125579|NCT01729871|BG001|Baseline|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
11125580|NCT01729871|BG002|Baseline|Total|Total of all reporting groups
11125581|NCT01729871|FG000|Participant Flow|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
11125582|NCT01729871|FG001|Participant Flow|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
11125583|NCT01729871|OG000|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
11125584|NCT01729871|OG001|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
11125585|NCT01729871|EG000|Reported Event|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
11125586|NCT01729871|EG001|Reported Event|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
11125587|NCT01729923|BG000|Baseline|Treatment (Capecitabine, Celecoxib, Radiation Therapy)|"Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.~RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.~ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Celecoxib: Given PO~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy~Stereotactic Radiosurgery: Undergo stereotactic radiosurgery~Therapeutic Conventional Surgery: Undergo surgical resection"
11126903|NCT01736241|OG001|Outcome|7 mg LY3053102|LY3053102: A single dose of 7 mg, administered subcutaneously.
11126904|NCT01736241|OG002|Outcome|20 mg LY3053102|LY3053102: A single dose of 20 mg, administered subcutaneously.
11126905|NCT01736241|OG003|Outcome|50 mg LY3053102|LY3053102: A single dose of 50 mg, administered subcutaneously.
11126906|NCT01736241|OG004|Outcome|150 mg LY3053102|LY3053102: A single dose of 150 mg, administered subcutaneously.
11126907|NCT01736241|OG005|Outcome|405 mg LY3053102|LY3053102: A single dose of 405 mg, administered subcutaneously.
11126908|NCT01736241|OG006|Outcome|Placebo|Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort.
11125588|NCT01729923|FG000|Participant Flow|Treatment (Capecitabine, Celecoxib, Radiation Therapy)|"Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.~RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.~ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Celecoxib: Given PO~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy~Stereotactic Radiosurgery: Undergo stereotactic radiosurgery~Therapeutic Conventional Surgery: Undergo surgical resection"
11125589|NCT01729923|OG000|Outcome|Capecitabine and Celecoxib|Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
11125590|NCT01729923|EG000|Reported Event|Treatment (Capecitabine, Celecoxib, Radiation Therapy)|"Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.~RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.~ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Celecoxib: Given PO~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy~Stereotactic Radiosurgery: Undergo stereotactic radiosurgery~Therapeutic Conventional Surgery: Undergo surgical resection"
11125591|NCT01730040|BG000|Baseline|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
11125592|NCT01730040|BG001|Baseline|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
11125593|NCT01730040|BG002|Baseline|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125594|NCT01730040|BG003|Baseline|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
11125595|NCT01730040|BG004|Baseline|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
11125596|NCT01730040|BG005|Baseline|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
11125597|NCT01730040|BG006|Baseline|Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125598|NCT01730040|BG007|Baseline|Total|Total of all reporting groups
11125599|NCT01730040|FG000|Participant Flow|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
11125600|NCT01730040|FG001|Participant Flow|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
11125601|NCT01730040|FG002|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125602|NCT01730040|FG003|Participant Flow|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
11126909|NCT01736241|OG000|Outcome|2 mg LY3053102|LY3053102: A single dose of 2 mg, administered subcutaneously.
11125603|NCT01730040|FG004|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
11125604|NCT01730040|FG005|Participant Flow|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
11125605|NCT01730040|FG006|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125606|NCT01730040|OG000|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
11125607|NCT01730040|OG001|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
11125608|NCT01730040|OG002|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125609|NCT01730040|OG003|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
11125610|NCT01730040|OG004|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
11125611|NCT01730040|OG005|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
11125612|NCT01730040|OG006|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125613|NCT01730040|EG000|Reported Event|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
11125614|NCT01730040|EG001|Reported Event|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
11125615|NCT01730040|EG002|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up¬-titrated to 150 mg Q2W from Week 12 when LDL-¬C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125616|NCT01730040|EG003|Reported Event|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
11125617|NCT01730040|EG004|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
11125618|NCT01730040|EG005|Reported Event|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.
11125619|NCT01730040|EG006|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11126910|NCT01736241|EG000|Reported Event|2 mg LY3053102|LY3053102: A single dose of 2 mg, administered subcutaneously.
11125620|NCT01730053|BG000|Baseline|Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.
11125621|NCT01730053|BG001|Baseline|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
11125622|NCT01730053|BG002|Baseline|Alirocumab 75/up to 150 + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125623|NCT01730053|BG003|Baseline|Rosuvastatin 40 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
11125624|NCT01730053|BG004|Baseline|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
11125625|NCT01730053|BG005|Baseline|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125626|NCT01730053|BG006|Baseline|Total|Total of all reporting groups
11125627|NCT01730053|FG000|Participant Flow|Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.
11125628|NCT01730053|FG001|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
11125629|NCT01730053|FG002|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125630|NCT01730053|FG003|Participant Flow|Rosuvastatin 40 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
11125631|NCT01730053|FG004|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
10848781|NCT00291499|BG001|Baseline|Placebo|Placebo: 800 mg placebo/day for 6 months
10848782|NCT00291499|BG002|Baseline|Total|Total of all reporting groups
10848783|NCT00291499|FG000|Participant Flow|Chondroitin 4&6 Sulfate (Condrosulf)|Chondroitin 4&6 sulfate (Condrosulf): 800 mg/day for 6 months
10848784|NCT00291499|FG001|Participant Flow|Placebo|Placebo: 800 mg placebo/day for 6 months
10848785|NCT00291499|OG000|Outcome|Chondroitin 4&6 Sulfate (Condrosulf)|Chondroitin 4&6 sulfate (Condrosulf): 800 mg/day for 6 months
10848786|NCT00291499|OG001|Outcome|Placebo|Placebo: 800 mg placebo/day for 6 months
10848787|NCT00291499|EG000|Reported Event|Chondroitin 4&6 Sulfate (Condrosulf)|Chondroitin 4&6 sulfate (Condrosulf): 800 mg/day for 6 months
10848788|NCT00291499|EG001|Reported Event|Placebo|Placebo: 800 mg placebo/day for 6 months
10848789|NCT00291551|BG000|Baseline|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
10848790|NCT00291551|FG000|Participant Flow|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
10848791|NCT00291551|OG000|Outcome|Non-randomized, Single Arm, Treatment|
10848792|NCT00291551|OG000|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
10848793|NCT00291551|EG000|Reported Event|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
10848794|NCT00291577|BG000|Baseline|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
10848795|NCT00291577|FG000|Participant Flow|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
10848796|NCT00291577|OG000|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
10878783|NCT00454207|OG000|Outcome|Sildenafil:Part II, Functional Class at Baseline: I|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were I. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878784|NCT00454207|OG001|Outcome|Sildenafil:Part II, Functional Class at Baseline: II|Consists of participants who newly entered the study from Part II period in Week 0, and whose who functional class at baseline were II. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878785|NCT00454207|OG002|Outcome|Sildenafil: Part II, Functional Class at Baseline: III|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were III. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878786|NCT00454207|OG003|Outcome|Sildenafil: Part II, Functional Class at Baseline: IV|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were IV. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878787|NCT00454207|OG000|Outcome|Sildenafil: Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
11125632|NCT01730053|FG005|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125633|NCT01730053|OG000|Outcome|Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.
11125634|NCT01730053|OG001|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
11125635|NCT01730053|OG002|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125636|NCT01730053|OG003|Outcome|Rosuvastatin 40 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
11125637|NCT01730053|OG004|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
11125638|NCT01730053|OG005|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125639|NCT01730053|OG005|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125640|NCT01730053|EG000|Reported Event|Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.
11125641|NCT01730053|EG001|Reported Event|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
11126911|NCT01736241|EG001|Reported Event|7 mg LY3053102|LY3053102: A single dose of 7 mg, administered subcutaneously.
11126912|NCT01736241|EG002|Reported Event|20 mg LY3053102|LY3053102: A single dose of 20 mg, administered subcutaneously.
11126913|NCT01736241|EG003|Reported Event|50 mg LY3053102|LY3053102: A single dose of 50 mg, administered subcutaneously.
10878788|NCT00454207|OG000|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
11125642|NCT01730053|EG002|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125643|NCT01730053|EG003|Reported Event|Rosuvastatin 40 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
11125644|NCT01730053|EG004|Reported Event|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
11125645|NCT01730053|EG005|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
11125646|NCT01730339|BG000|Baseline|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
11125647|NCT01730339|BG001|Baseline|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
11125648|NCT01730339|BG002|Baseline|Total|Total of all reporting groups
11125649|NCT01730339|FG000|Participant Flow|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
11125650|NCT01730339|FG001|Participant Flow|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
11125651|NCT01730339|OG000|Outcome|Group 1: PF-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
11125652|NCT01730339|OG001|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
11125653|NCT01730339|OG002|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
11125654|NCT01730339|OG003|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
11125655|NCT01730339|OG000|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
11125656|NCT01730339|OG001|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast
11125657|NCT01730339|OG002|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
11125658|NCT01730339|OG003|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, also received 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
11125659|NCT01730339|OG001|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
11125660|NCT01730339|OG000|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm, (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
11125661|NCT01730339|OG001|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
11125662|NCT01730339|OG000|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
11125663|NCT01730339|EG000|Reported Event|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
11125664|NCT01730339|EG001|Reported Event|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
11125665|NCT01730378|BG000|Baseline|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
11125666|NCT01730378|BG001|Baseline|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
11125667|NCT01730378|BG002|Baseline|Total|Total of all reporting groups
11125668|NCT01730378|FG000|Participant Flow|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
11125669|NCT01730378|FG001|Participant Flow|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
11125670|NCT01730378|OG000|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
11125671|NCT01730378|OG000|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
11125672|NCT01730378|OG001|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
11125673|NCT01730378|EG000|Reported Event|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
11125674|NCT01730378|EG001|Reported Event|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
11125675|NCT01730534|BG000|Baseline|Dapa 10 mg|Dapagliflozin 10 mg tablets administered orally once daily
11125676|NCT01730534|BG001|Baseline|Placebo|Matching placebo for dapagliflozin 10 mg administered orally once daily
11125677|NCT01730534|BG002|Baseline|Total|Total of all reporting groups
11125678|NCT01730534|FG000|Participant Flow|Dapa 10 mg|Dapagliflozin 10 mg tablets administered orally once daily
11125679|NCT01730534|FG001|Participant Flow|Placebo|Matching placebo for dapagliflozin 10 mg administered orally once daily
11125680|NCT01730534|OG000|Outcome|Dapa 10 mg|Dapagliflozin 10 mg tablets administered orally once daily
11125681|NCT01730534|OG001|Outcome|Placebo|Matching placebo for dapagliflozin 10 mg administered orally once daily
11125682|NCT01730534|EG000|Reported Event|Dapa 10 mg|Description (Arm-group)
11125683|NCT01730534|EG001|Reported Event|Placebo|Description (Arm-group)
11125684|NCT01730586|BG000|Baseline|Abraxane|Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
11125685|NCT01730586|FG000|Participant Flow|Abraxane|Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
11125686|NCT01730586|OG000|Outcome|CIMP-high Colorectal Cancer|Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
11125687|NCT01730586|OG001|Outcome|Small Bowel Adenocarcinoma (SBA)|Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
11125688|NCT01730586|OG001|Outcome|Small Bowel Adenocarcinoma|Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
11125689|NCT01730586|EG000|Reported Event|Abraxane|Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
11125690|NCT01730729|BG000|Baseline|Treatment (Cabergoline)|"Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~cabergoline: Given orally"
11125691|NCT01730729|FG000|Participant Flow|Treatment (Cabergoline)|"Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~cabergoline: Given orally"
11125692|NCT01730729|OG000|Outcome|Treatment (Cabergoline)|"Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~cabergoline: Given orally"
11125693|NCT01730729|EG000|Reported Event|Treatment (Cabergoline)|"Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~cabergoline: Given orally"
11125694|NCT01730846|BG000|Baseline|Placebo|"Placebo~Placebo controlled"
11125695|NCT01730846|BG001|Baseline|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
11125696|NCT01730846|BG002|Baseline|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
11125697|NCT01730846|BG003|Baseline|Total|Total of all reporting groups
11125698|NCT01730846|FG000|Participant Flow|Placebo|"Placebo~Placebo controlled"
11125699|NCT01730846|FG001|Participant Flow|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
11125700|NCT01730846|FG002|Participant Flow|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
11125701|NCT01730846|OG000|Outcome|Placebo|"Placebo~Placebo controlled"
11125702|NCT01730846|OG001|Outcome|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
11125703|NCT01730846|OG002|Outcome|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
11125704|NCT01730846|EG000|Reported Event|Placebo|"Placebo~Placebo controlled"
11125705|NCT01730846|EG001|Reported Event|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
11125706|NCT01730846|EG002|Reported Event|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
11125707|NCT01730872|BG000|Baseline|Prednisolone|"Prednisolone Sodium Phosphate Ophthalmic Solution, 1%~Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days."
11125708|NCT01730872|BG001|Baseline|Placebo|"Tears Naturale II Ophthalmic Solution, 1%~Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days"
11125709|NCT01730872|BG002|Baseline|Saline|A group of three allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization.
11125710|NCT01730872|BG003|Baseline|Total|Total of all reporting groups
11125711|NCT01730872|FG000|Participant Flow|Prednisolone|"Prednisolone Sodium Phosphate Ophthalmic Solution, 1%~Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days."
11125712|NCT01730872|FG001|Participant Flow|Placebo|"Tears Naturale II Ophthalmic Solution, 1%~Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days"
11125713|NCT01730872|FG002|Participant Flow|Control|Subjects received CAC using saline instead of allergen
11125714|NCT01730872|OG000|Outcome|Prednisolone|"Prednisolone Sodium Phosphate Ophthalmic Solution, 1%~Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days."
11125715|NCT01730872|OG001|Outcome|Placebo|"Tears Naturale II Ophthalmic Solution, 1%~Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days"
11125716|NCT01730872|EG000|Reported Event|Prednisolone|"Prednisolone Sodium Phosphate Ophthalmic Solution, 1%~Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days."
11125717|NCT01730872|EG001|Reported Event|Placebo|"Tears Naturale II Ophthalmic Solution, 1%~Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days"
11125718|NCT01730872|EG002|Reported Event|Saline|A group of five allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization.
11125719|NCT01730950|BG000|Baseline|Bevacizumab|Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125720|NCT01730950|BG001|Baseline|Bevacizumab + RT|Radiation therapy (35Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125721|NCT01730950|BG002|Baseline|Total|Total of all reporting groups
11125722|NCT01730950|FG000|Participant Flow|Bevacizumab|Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125723|NCT01730950|FG001|Participant Flow|Bevacizumab + RT|Radiation therapy (35Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125724|NCT01730950|OG000|Outcome|Bevacizumab|Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125725|NCT01730950|OG001|Outcome|Bevacizumab + RT|Radiation therapy (35 Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125726|NCT01730950|OG000|Outcome|Bevacizumab + RT|Radiation therapy (35 Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125727|NCT01730950|EG000|Reported Event|Bevacizumab|Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125728|NCT01730950|EG001|Reported Event|Bevacizumab + RT|Radiation therapy (35Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
11125729|NCT01731002|BG000|Baseline|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
11125730|NCT01731002|BG001|Baseline|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
11125731|NCT01731002|BG002|Baseline|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
11125732|NCT01731002|BG003|Baseline|Total|Total of all reporting groups
11125733|NCT01731002|FG000|Participant Flow|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
11125734|NCT01731002|FG001|Participant Flow|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
11125735|NCT01731002|FG002|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
11125736|NCT01731002|OG000|Outcome|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
11125737|NCT01731002|OG001|Outcome|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
11125738|NCT01731002|OG002|Outcome|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
11125739|NCT01731002|EG000|Reported Event|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
11125740|NCT01731002|EG001|Reported Event|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
11125741|NCT01731002|EG002|Reported Event|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
11125742|NCT01731041|BG000|Baseline|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
11125743|NCT01731041|BG001|Baseline|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
11125744|NCT01731041|BG002|Baseline|Total|Total of all reporting groups
11126914|NCT01736241|EG004|Reported Event|150 mg LY3053102|LY3053102: A single dose of 150 mg, administered subcutaneously.
11125745|NCT01731041|FG000|Participant Flow|Ticagrelor 180mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
11125746|NCT01731041|FG001|Participant Flow|Ticagrelor 90mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
11125747|NCT01731041|OG000|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
11125748|NCT01731041|OG001|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
11125749|NCT01731041|EG000|Reported Event|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
11125750|NCT01731041|EG001|Reported Event|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
11125751|NCT01731119|BG000|Baseline|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
11125752|NCT01731119|FG000|Participant Flow|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
11125753|NCT01731119|OG000|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
11125754|NCT01731119|EG000|Reported Event|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
11125755|NCT01731171|BG000|Baseline|Probiotic Supplement|"The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.~Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily"
11125756|NCT01731171|BG001|Baseline|Inert Compound|"The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.~Inert Compound: Probiotic identical placebo 1 tablet by mouth daily"
11125757|NCT01731171|BG002|Baseline|Total|Total of all reporting groups
11125758|NCT01731171|FG000|Participant Flow|Probiotic Supplement|"The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.~Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily"
11125759|NCT01731171|FG001|Participant Flow|Inert Compound|"The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.~Inert Compound: Probiotic identical placebo 1 tablet by mouth daily"
11126915|NCT01736241|EG005|Reported Event|405 mg LY3053102|LY3053102: A single dose of 405 mg, administered subcutaneously.
11006832|NCT01088048|FG004|Participant Flow|Idelalisib + Rituximab + Bendamustine|"Participants with CLL, iNHL and MCL received treatments as follows:~Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6~Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006833|NCT01088048|FG005|Participant Flow|Idelalisib + Ofatumumab|"Participants with CLL received treatments as follows:~Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))"
11006834|NCT01088048|FG006|Participant Flow|Idelalisib + Fludarabine|"Participants with CLL received treatments as follows:~Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6"
11006835|NCT01088048|FG007|Participant Flow|Idelalisib + Chlorambucil|"Participants with CLL received treatments as follows:~Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11006836|NCT01088048|FG008|Participant Flow|Idelalisib + Rituximab + Chlorambucil|"Participants with CLL received treatments as follows:~Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11006837|NCT01088048|FG009|Participant Flow|Idelalisib + Rituximab + Lenalidomide|"Participants with CLL and iNHL received treatments as follows:~Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles"
11006838|NCT01088048|OG000|Outcome|Idelalisib + Rituximab|"Participants with chronic CLL and iNHL received treatments as follows:~Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2~Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2"
11006839|NCT01088048|OG001|Outcome|Idelalisib + Bendamustine|"Participants with CLL and iNHL received treatments as follows:~Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006840|NCT01088048|OG002|Outcome|Idelalisib + Everolimus|"Participants with MCL received treatments as follows:~Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle"
11006841|NCT01088048|OG003|Outcome|Idelalisib + Bortezomib|"Participants with MCL received treatments as follows:~Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle"
11006842|NCT01088048|OG004|Outcome|Idelalisib + Rituximab + Bendamustine|"Participants with CLL, iNHL and MCL received treatments as follows:~Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6~Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006843|NCT01088048|OG005|Outcome|Idelalisib + Ofatumumab|"Participants with CLL received treatments as follows:~Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))"
11006844|NCT01088048|OG006|Outcome|Idelalisib + Fludarabine|"Participants with CLL received treatments as follows:~Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6"
11006845|NCT01088048|OG007|Outcome|Idelalisib + Chlorambucil|"Participants with CLL received treatments as follows:~Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11006846|NCT01088048|OG008|Outcome|Idelalisib + Rituximab + Chlorambucil|"Participants with CLL received treatments as follows:~Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11125760|NCT01731171|OG000|Outcome|Probiotic Supplement|"The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.~Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily"
11125761|NCT01731171|OG001|Outcome|Inert Compound|"The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.~Inert Compound: Probiotic identical placebo 1 tablet by mouth daily"
11125762|NCT01731171|EG000|Reported Event|Probiotic Supplement|"The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.~Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily"
11125763|NCT01731171|EG001|Reported Event|Inert Compound|"The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.~Inert Compound: Probiotic identical placebo 1 tablet by mouth daily"
11125764|NCT01731470|BG000|Baseline|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
11125765|NCT01731470|FG000|Participant Flow|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
11125766|NCT01731470|OG000|Outcome|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
11125767|NCT01731470|EG000|Reported Event|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
11125768|NCT01731600|BG000|Baseline|Younger Children (0 - 5 Years)|Participants (0 - 5 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). Prophylaxis: N8-GP as a single bolus iv injection 60 IU/kg twice weekly. Treatment of bleeding episodes: N8-GP ranging from 20-75 IU/kg, according to severity and location of bleeding episode. The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days). After completion of main phase, subjects could continue until the end of the extension phase, which was defined as LPLV. All subjects continued twice weekly or every third day prophylaxis regimen in extension phase as prescribed for main phase. However, after 12 months treatment with N8-GP (main phase+extension phase) the investigator was permitted to prescribe extra coverage before physical activities.
11125769|NCT01731600|BG001|Baseline|Older Children (6 - 11 Years)|Participants (6 - 11 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). Prophylaxis: N8-GP as a single bolus iv injection 60 IU/kg twice weekly. Treatment of bleeding episodes: N8-GP ranging from 20-75 IU/kg, according to severity and location of bleeding episode. The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days). After completion of main phase, subjects could continue until the end of the extension phase, which was defined as LPLV. All subjects continued twice weekly or every third day prophylaxis regimen in extension phase as prescribed for main phase. However, after 12 months treatment with N8-GP (main phase+extension phase) the investigator was permitted to prescribe extra coverage before physical activities.
11125770|NCT01731600|BG002|Baseline|Total|Total of all reporting groups
11125771|NCT01731600|FG000|Participant Flow|Younger Children (0 - 5 Years)|Participants (0 - 5 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). Prophylaxis: N8-GP as a single bolus iv injection 60 IU/kg twice weekly. Treatment of bleeding episodes: N8-GP ranging from 20-75 IU/kg, according to severity and location of bleeding episode. The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days). After completion of main phase, subjects could continue until the end of the extension phase, which was defined as LPLV. All subjects continued twice weekly or every third day prophylaxis regimen in extension phase as prescribed for main phase. However, after 12 months treatment with N8-GP (main phase+extension phase) the investigator was permitted to prescribe extra coverage before physical activities.
11125772|NCT01731600|FG001|Participant Flow|Older Children (6 - 11 Years)|Participants (6 - 11 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). Prophylaxis: N8-GP as a single bolus iv injection 60 IU/kg twice weekly. Treatment of bleeding episodes: N8-GP ranging from 20-75 IU/kg, according to severity and location of bleeding episode. The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days). After completion of main phase, subjects could continue until the end of the extension phase, which was defined as LPLV. All subjects continued twice weekly or every third day prophylaxis regimen in extension phase as prescribed for main phase. However, after 12 months treatment with N8-GP (main phase+extension phase) the investigator was permitted to prescribe extra coverage before physical activities.
11125773|NCT01731600|OG000|Outcome|Younger Children (0 - 5 Years) [Main Trial]|Participants (0 - 5 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days).
11125774|NCT01731600|OG001|Outcome|Older Children (6 - 11 Years) [Main Trial]|Participants (6 - 11 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days).
11125775|NCT01731600|OG002|Outcome|Younger Children (0 - 5 Years) [Full Trial]|Participants (0 - 5 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days). After completion of main phase, subjects could continue until the end of the extension phase, which was defined as LPLV. All subjects continued twice weekly or every third day prophylaxis regimen in extension phase as prescribed for main phase. However, after 12 months treatment with N8-GP (main phase+extension phase) the investigator was permitted to prescribe extra coverage before physical activities.
11126916|NCT01736241|EG006|Reported Event|Placebo|Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort.
11125776|NCT01731600|OG003|Outcome|Older Children (6 - 11 Years) [Full Trial]|Participants (6 - 11 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days). After completion of main phase, subjects could continue until the end of the extension phase, which was defined as LPLV. All subjects continued twice weekly or every third day prophylaxis regimen in extension phase as prescribed for main phase. However, after 12 months treatment with N8-GP (main phase+extension phase) the investigator was permitted to prescribe extra coverage before physical activities.
11125777|NCT01731600|OG000|Outcome|Younger Children (0 - 5 Years) [Full Trial]|Participants (0 - 5 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days). After completion of main phase, subjects could continue until the end of the extension phase, which was defined as LPLV. All subjects continued twice weekly or every third day prophylaxis regimen in extension phase as prescribed for main phase. However, after 12 months treatment with N8-GP (main phase+extension phase) the investigator was permitted to prescribe extra coverage before physical activities.
11125778|NCT01731600|OG001|Outcome|Older Children (6 - 11 Years) [Full Trial]|Participants (6 - 11 years) previously treated with FVIII received N8-GP (prophylaxis or treatment of bleeding episodes). The trial consisted of main and extension phase. Duration of main phase for each subject was approximately 26 weeks (50 exposure days). After completion of main phase, subjects could continue until the end of the extension phase, which was defined as LPLV. All subjects continued twice weekly or every third day prophylaxis regimen in extension phase as prescribed for main phase. However, after 12 months treatment with N8-GP (main phase+extension phase) the investigator was permitted to prescribe extra coverage before physical activities.
11125779|NCT01731600|EG000|Reported Event|Younger Children£(0-5 Years)|
11125780|NCT01731600|EG001|Reported Event|Older Children£(6-11 Years)|
11125781|NCT01731678|BG000|Baseline|Transcranial Magnetic Stimulation|The standardized treatment location is the left DLPFC. Anatomical T1 images from the pre-intervention MRI were loaded into our neuronavigation software (Brainsight2, Rogue Research, Montreal). The coil was placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) consisted of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
11125782|NCT01731678|FG000|Participant Flow|Transcranial Magnetic Stimulation|The standardized treatment location is the left DLPFC. Anatomical T1 images from the pre-intervention MRI were loaded into our neuronavigation software (Brainsight2, Rogue Research, Montreal). The coil was placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) consisted of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
11125783|NCT01731678|OG000|Outcome|Transcranial Magnetic Stimulation|The standardized treatment location is the left DLPFC. Anatomical T1 images from the pre-intervention MRI were loaded into our neuronavigation software (Brainsight2, Rogue Research, Montreal). The coil was placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) consisted of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
11125784|NCT01731678|EG000|Reported Event|Transcranial Magnetic Stimulation|The standardized treatment location is the left DLPFC. Anatomical T1 images from the pre-intervention MRI were loaded into our neuronavigation software (Brainsight2, Rogue Research, Montreal). The coil was placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) consisted of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
11125785|NCT01731691|BG000|Baseline|α1 Proteinase Inhibitor in HIV Disease|"α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks~α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.~The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group."
11125786|NCT01731691|BG001|Baseline|Placebo in HIV Disease|"Placebos weekly for 8 weeks~Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.~The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group."
11125787|NCT01731691|BG002|Baseline|Uninfected Controls|"Blood collection only for 8 weeks~The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group."
11125788|NCT01731691|BG003|Baseline|Total|Total of all reporting groups
11125789|NCT01731691|FG000|Participant Flow|α1 Proteinase Inhibitor in HIV Disease|"α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks~α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers."
11125790|NCT01731691|FG001|Participant Flow|Placebo in HIV Disease|"Placebos weekly for 8 weeks~Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers."
11125791|NCT01731691|FG002|Participant Flow|Uninfected Controls|Blood collection only for 8 weeks
11125792|NCT01731691|OG000|Outcome|α1 Proteinase Inhibitor in HIV Disease|"α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks~α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.~The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group."
11125793|NCT01731691|OG001|Outcome|Placebo in HIV Disease|"Placebos weekly for 8 weeks~Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.~The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group."
11125794|NCT01731691|OG002|Outcome|Uninfected Controls|"Blood collection only for 8 weeks~The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group."
11125795|NCT01731691|OG000|Outcome|α1 Proteinase Inhibitor in HIV Disease|"α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks~α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers."
11125796|NCT01731691|OG001|Outcome|Placebo in HIV Disease|"Placebos weekly for 8 weeks~Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers."
11125797|NCT01731691|OG002|Outcome|Uninfected Controls|Blood collection only for 8 weeks
11125798|NCT01731691|EG000|Reported Event|α1 Proteinase Inhibitor in HIV Disease|"α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks~α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers."
11125799|NCT01731691|EG001|Reported Event|Placebo in HIV Disease|"Placebos weekly for 8 weeks~Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers."
11125800|NCT01731691|EG002|Reported Event|Uninfected Controls|Blood collection only for 8 weeks
11125801|NCT01731886|BG000|Baseline|Arm A: Low-dose Dexamethasone + Stem Cell Transplantation|Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
11125802|NCT01731886|BG001|Baseline|Arm B: Low-dose Dexamethasone|Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
11125803|NCT01731886|BG002|Baseline|Total|Total of all reporting groups
11125804|NCT01731886|FG000|Participant Flow|Arm A: Low-dose Dexamethasone + Stem Cell Transplantation|"Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).~Autologous peripheral blood stem cell transplant: Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.~Lenalidomide: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.~Dexamethasone: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.~Stem cell collection: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.~Melphalan: Subjects undergoing autologous peripheral blood stem cell transplant will receive"
11125805|NCT01731886|FG001|Participant Flow|Arm B: Low-dose Dexamethasone|"Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).~Lenalidomide: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.~Dexamethasone: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.~Stem cell collection: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.~Cyclophosphamide: Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.~Mesna: Mesna will be provided with the cyclophosphamide."
11125806|NCT01731886|OG000|Outcome|Arm A: Low-dose Dexamethasone + Stem Cell Transplantation|Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
11125807|NCT01731886|OG001|Outcome|Arm B: Low-dose Dexamethasone|Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
11125808|NCT01731886|OG001|Outcome|Arm B: Low-dose Dexamethasone|"Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).~Only includes subjects who received drug."
11125809|NCT01731886|EG000|Reported Event|Arm A: Low-dose Dexamethasone + Stem Cell Transplantation|Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
11125810|NCT01731886|EG001|Reported Event|Arm B: Low-dose Dexamethasone|"Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).~Only includes subjects who received drug."
11006847|NCT01088048|OG009|Outcome|Idelalisib + Rituximab + Lenalidomide|"Participants with CLL and iNHL received treatments as follows:~Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles"
11006848|NCT01088048|OG000|Outcome|Idelalisib 100 mg (Cohort 1)|"Participants analyzed for this group included participants from Cohort 1 (subcohort 1a and 1b) who received the treatments as follows:~Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2~Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycle 1 - 6"
11006849|NCT01088048|OG001|Outcome|Idelalisib 150 mg (Cohorts 2 and 3)|"Participants analyzed for this group included participants from Cohort 2a, 2b, 3a, 3b, 3c, 3e, 3f, 3g who received the treatments as follows:~Cohort 2a: IDELA 150 mg orally (po) BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, D8, D15, & D22, C1 & C2~Cohort 2b: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m^2 IV, D1 & D2, C1 - C6~Cohorts 3a and 3b: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, C1 - C6 + bendamustine 90 mg/m^2 (Cohort 3a only) IV, D1 & D2, C1 - C6 + bendamustine 70 mg/m^2 (Cohort 3b only) IV on D1 & D2, C1 - C6~Cohort 3c: IDELA 150 mg po BID, D1 - D28 of each cycle + ofatumumab 12 doses (300 mg (D1 or D2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))~Cohort 3d: IDELA 150 mg po BID, D1 - D28 of each cycle + fludarabine 40 mg/m^2 po D1 - D5, C1 - C6~Cohort 3e: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, D8, D15, & D22, C1 & C2~Cohorts 3f and 3g: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m^2 (cohort 3f only) IV, D1 & D2, C1 - C6 + bendamustine 70 mg/m^2 (Cohort 3g only) IV, D1 & D2, C1 - C6~C= Cycle D= Day Cycle length= 28 days"
11006850|NCT01088048|OG002|Outcome|Idelalisib 150 mg (Cohort 5)|"Participants analyzed for this group included participants from Cohort 5 (subcohorts 5a, 5b, and 5c) who received the treatments as follows:~Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle~Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle~Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006851|NCT01088048|OG000|Outcome|Idelalisib 150 mg (Cohort 4)|"Participants analyzed for this group included participants from Cohort 4 (subcohorts 4a and 4b) who received the treatments as follows:~Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006852|NCT01088048|OG000|Outcome|Idelalisib 150 mg (Cohort 6)|"Participants analyzed for this group included participants from Cohort 6 (subcohorts 6a and 6b) who received the treatments as follows~Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12~Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11006853|NCT01088048|OG000|Outcome|Idelalisib 150 mg (Cohort 7)|"Participants analyzed for this group included participants from Cohort 7 (subcohorts 7a, 7b, and 7c) who received the treatments as follows:~Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles"
11006854|NCT01088048|OG000|Outcome|Idelalisib 100 mg (Cohort 1a, 1b)|"Participants analyzed for this group included participants from Cohort 1 who received the treatments as follows:~Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2~Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11007963|NCT01093885|OG000|Outcome|Open Label: Medication Ambrisentan|"Open label study of Ambrisentan.~Ambrisentan will begin at 5mg daily for the first month.~Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week. Subjects will continue their present dose and schedule of disease modifying/antifibrotic medication for the duration of the study.~** Dose escalation was attempted however none of the patients were able to increase. Therefore all subjects remained on 5 mg daily throughout the study.~Ambrisentan: Drug is dispensed in tablet form. Ambrisentan with anti-fibrotic to assess benefit on skin~Dosing of ambrisentan will begin at 5mg daily for the first month. Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week."
11125811|NCT01731912|BG000|Baseline|Degarelix|Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
11125812|NCT01731912|FG000|Participant Flow|Degarelix|Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
11125813|NCT01731912|OG000|Outcome|Degarelix|Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
11125814|NCT01731912|EG000|Reported Event|Degarelix|Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
11125815|NCT01731938|BG000|Baseline|Fibrin Sealant (FS) Grifols Part I|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
11125816|NCT01731938|BG001|Baseline|Surgicel® Part I|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
11125817|NCT01731938|BG002|Baseline|Fibrin Sealant (FS) Grifols Part II|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
11125818|NCT01731938|BG003|Baseline|Surgicel® Part II|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
11125819|NCT01731938|BG004|Baseline|Total|Total of all reporting groups
11125820|NCT01731938|FG000|Participant Flow|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
11125821|NCT01731938|FG001|Participant Flow|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
11125822|NCT01731938|OG000|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
11125823|NCT01731938|OG001|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
11125824|NCT01731938|OG000|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
11125825|NCT01731938|EG000|Reported Event|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
11125826|NCT01731938|EG001|Reported Event|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
11125827|NCT01731951|BG000|Baseline|Arm A: Imetelstat 9.4 mg/kg (MF)|Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125828|NCT01731951|BG001|Baseline|Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)|Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11126917|NCT01736254|BG000|Baseline|All Participants|"All participants were assigned to the following treatment regimen:~Period 1: Single oral dose of 600 mg gemfibrozil in the morning of Day 1.~Period 2: Oral doses of 130 mg evacetrapib QD for 11 days (Days 2 to 12).~Period 3: Oral doses of 600 mg gemfibrozil BID and 130 mg evacetrapib QD for 10 days (Days 13 to 22), with a single dose of 600 mg gemfibrozil on Day 23."
11006855|NCT01088048|OG001|Outcome|Idelalisib 150 mg (Cohorts 2a, 2b, 3a, 3c, 3d, 3e, 3f, 3g, 4a, 4b)|"Participants included for analysis received treatments as follows:~Cohort 2a: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, D8, D15, & D22, C1 & C2~Cohort 2b: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m^2 IV, D1 & D2, C1 - C6~Cohorts 3a and 3b: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, C1 - C6 + bendamustine 90 mg/m^2 (Cohort 3a only) IV, D1 & D2, C1 - C6 + bendamustine 70 mg/m^2 (Cohort 3b only) IV on D1 & D2, C1 - C6~Cohort 3c: IDELA 150 mg po BID, D1 - D28 of each cycle + ofatumumab 12 doses (300 mg (D1 or D2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))~Cohort 3d: IDELA 150 mg po BID, D1 - D28 of each cycle + fludarabine 40 mg/m^2 po D1 - D5, C1 - C6~Cohort 3e: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, D8, D15, & D22, C1 & C2~Cohorts 3f and 3g: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m^2 (Cohort 3f only) IV, D1 & D2, C1 - C6 + bendamustine 70 mg/m^2 (Cohort 3g only) IV, D1 & D2, C1 - C6~Cohort 4a: IDELA 150 mg po BID, D1 - D28 of each cycle (starting C2 D1) + rituximab 375 mg/m^2 IV, D1, D8, D15, & D22, C1 & C2~Cohort 4b: IDELA 150 mg po BID, D1 - D28 of each cycle (starting C2, D3) + bendamustine 90 mg/m^2 IV, D1 & D2, C1 - C6~C= Cycle D= Day Cycle length= 28 days"
11006856|NCT01088048|OG000|Outcome|Bendamustine (Cohorts 1b, 2b, 3a, 3b, 3f, 3g, 4b, 5c)|"Participants included for analysis received treatments as follows:~Cohort 1b: IDELA 100 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 2b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3a: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6~Cohort 3f: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3g: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 4b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 5c: IDELA 150 mg po BID on Days 1 - 28 + rituximab 375 mg/m^2 IV on Day 1, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2, Cycles 1 - 6 (Cycle length= 28 days)"
11006857|NCT01088048|OG000|Outcome|Everolimus (Cohort 5a)|"Participants analyzed for this group included participants from Cohort 5 (subcohort 5a) who received the treatments as follows:~Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle"
11006858|NCT01088048|OG000|Outcome|Lenalidomide (Cohort 7a, 7b, 7c)|"Participants analyzed for this group included participants from Cohort 7 (subcohorts 7a, 7b, and 7c) who received the treatments as follows:~Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles"
11006859|NCT01088048|EG000|Reported Event|Idelalisib + Rituximab|"Participants with chronic CLL and iNHL received treatments as follows:~Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2~Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2~Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2"
11006860|NCT01088048|EG001|Reported Event|Idelalisib + Bendamustine|"Participants with CLL and iNHL received treatments as follows:~Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11006861|NCT01088048|EG002|Reported Event|Idelalisib + Everolimus|"Participants with MCL received treatments as follows:~Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle"
11006862|NCT01088048|EG003|Reported Event|Idelalisib + Bortezomib|"Participants with MCL received treatments as follows:~Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle"
11006863|NCT01088048|EG004|Reported Event|Idelalisib + Rituximab + Bendamustine|"Participants with CLL, iNHL and MCL received treatments as follows:~Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6~Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6~Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6"
11125829|NCT01731951|BG002|Baseline|Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)|Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125830|NCT01731951|BG003|Baseline|Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])|Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125831|NCT01731951|BG004|Baseline|Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])|Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125832|NCT01731951|BG005|Baseline|Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)|Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125833|NCT01731951|BG006|Baseline|Total|Total of all reporting groups
11125834|NCT01731951|FG000|Participant Flow|Arm A: Imetelstat 9.4 mg/kg (MF)|Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 milligram per kilogram (mg/kg), intravenously (IV) as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125835|NCT01731951|FG001|Participant Flow|Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)|Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125836|NCT01731951|FG002|Participant Flow|Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)|Participants with blast-phase myelofibrosis/acute myeloid leukemia (MF/AML) received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125837|NCT01731951|FG003|Participant Flow|Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])|Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
10845273|NCT00266032|EG001|Reported Event|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
11125838|NCT01731951|FG004|Participant Flow|Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])|Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125839|NCT01731951|FG005|Participant Flow|Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)|Participants with either myelodysplastic syndromes/ myeloproliferative neoplasm (MDS/MPN) or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125840|NCT01731951|OG000|Outcome|Arm A: Imetelstat 9.4 mg/kg (MF)|Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125841|NCT01731951|OG001|Outcome|Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)|Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125842|NCT01731951|OG002|Outcome|Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])|Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125843|NCT01731951|OG003|Outcome|Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])|Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125844|NCT01731951|OG000|Outcome|Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)|Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125845|NCT01731951|OG000|Outcome|Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)|Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125846|NCT01731951|OG002|Outcome|Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)|Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125847|NCT01731951|OG003|Outcome|Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])|Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125848|NCT01731951|OG004|Outcome|Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])|Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125849|NCT01731951|OG005|Outcome|Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)|Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125850|NCT01731951|EG000|Reported Event|Arm A: Imetelstat 9.4 mg/kg (MF)|Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125851|NCT01731951|EG001|Reported Event|Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)|Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125852|NCT01731951|EG002|Reported Event|Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia|Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125853|NCT01731951|EG003|Reported Event|Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])|Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11126918|NCT01736254|FG000|Participant Flow|All Participants|"All participants were assigned to the following treatment regimen:~Period 1: Single oral dose of 600 milligrams (mg) gemfibrozil in the morning of Day 1.~Period 2: Oral doses of 130 mg evacetrapib once a day (QD) for 11 days (Days 2 to 12).~Period 3: Oral doses of 600 mg gemfibrozil twice a day (BID) and 130 mg evacetrapib QD for 10 days (Days 13 to 22), with a single dose of 600 mg gemfibrozil on Day 23."
11126919|NCT01736254|OG000|Outcome|Evacetrapib|Oral doses of 130 mg evacetrapib QD for 10 days (Day 2 through Day 12).
11125854|NCT01731951|EG004|Reported Event|Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])|Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125855|NCT01731951|EG005|Reported Event|Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)|Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).
11125856|NCT01731990|BG000|Baseline|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
11125857|NCT01731990|BG001|Baseline|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
11125858|NCT01731990|BG002|Baseline|Total|Total of all reporting groups
11125859|NCT01731990|FG000|Participant Flow|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
11125860|NCT01731990|FG001|Participant Flow|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
11125861|NCT01731990|OG000|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
11125862|NCT01731990|OG001|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
11125863|NCT01731990|EG000|Reported Event|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
11125864|NCT01731990|EG001|Reported Event|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
11125865|NCT01732107|BG000|Baseline|Dovitinib|"Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.~Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2."
11125866|NCT01732107|FG000|Participant Flow|Dovitinib|"Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.~Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2."
11125867|NCT01732107|OG000|Outcome|Dovitinib|"Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.~Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2."
11125868|NCT01732107|EG000|Reported Event|Dovitinib|"Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.~Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2."
11125869|NCT01732263|BG000|Baseline|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125870|NCT01732263|BG001|Baseline|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125871|NCT01732263|BG002|Baseline|Total|Total of all reporting groups
11125872|NCT01732263|FG000|Participant Flow|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125873|NCT01732263|FG001|Participant Flow|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125874|NCT01732263|OG000|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125875|NCT01732263|OG001|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125876|NCT01732263|OG002|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125877|NCT01732263|OG003|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125878|NCT01732263|OG004|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125879|NCT01732263|OG005|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
11125880|NCT01732263|EG000|Reported Event|Hepatic Impairment|
11125881|NCT01732263|EG001|Reported Event|Matched Healthy Subjects|
11125882|NCT01732406|BG000|Baseline|Acomegaly With Pegvisomant|Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.
11125883|NCT01732406|BG001|Baseline|Acromegaly With Somatostatin Analog|Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly
11125884|NCT01732406|BG002|Baseline|Active Acromegaly|Patients not on drugs for treatment of acromegaly
11125885|NCT01732406|BG003|Baseline|Total|Total of all reporting groups
11125886|NCT01732406|FG000|Participant Flow|Acomegaly With Pegvisomant|Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.
11125887|NCT01732406|FG001|Participant Flow|Acromegaly With Somatostatin Analog|Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly
11125888|NCT01732406|FG002|Participant Flow|Active Acromegaly|Patients not on drugs for treatment of acromegaly
11125889|NCT01732406|OG000|Outcome|Acromegaly With Pegvisomant|No adverse events were experienced in this study.
11125890|NCT01732406|OG001|Outcome|Acromegaly With Somatostatin Analog|No adverse events were experienced in this study.
11125891|NCT01732406|OG002|Outcome|Active Acromegaly|No adverse events were experienced in this study.
11125892|NCT01732406|OG000|Outcome|Acomegaly With Pegvisomant|Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.
11125893|NCT01732406|OG001|Outcome|Acromegaly With Somatostatin Analog|Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly
11125894|NCT01732406|OG002|Outcome|Active Acromegaly|Patients not on drugs for treatment of acromegaly
11125895|NCT01732406|OG000|Outcome|Acromegaly With Pegvisomant|Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.
11125896|NCT01732406|EG000|Reported Event|Acromegaly on Pegvisomant|Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.
11125897|NCT01732406|EG001|Reported Event|Acromegaly on Somatostatin Analog|Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly.
11125898|NCT01732406|EG002|Reported Event|Active Acromegaly|Patients receiving no medications to treat active acromegaly.
11125899|NCT01732419|BG000|Baseline|Home-based Training|"After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.~Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.~Home-based training: Home-based exercise training for cardiac patients."
11125900|NCT01732419|BG001|Baseline|Centre-based Training|"Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.~Centre-based training: Usual exercise training in an outpatient setting."
11125901|NCT01732419|BG002|Baseline|Total|Total of all reporting groups
11125902|NCT01732419|FG000|Participant Flow|Home-based Training|"After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.~Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.~Home-based training: Home-based exercise training for cardiac patients."
11125903|NCT01732419|FG001|Participant Flow|Centre-based Training|"Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.~Centre-based training: Usual exercise training in an outpatient setting."
11126920|NCT01736254|OG001|Outcome|Evacetrapib + Gemfibrozil|Oral doses of 600 mg gemfibrozil BID and 130 mg evacetrapib QD for 10 days (Day 13 through Day 22). Single oral dose of 600 mg gemfibrozil on Day 23.
11126921|NCT01736254|OG000|Outcome|Gemfibrozil|Single oral dose of 600 mg gemfibrozil on Day 1.
11125904|NCT01732419|OG000|Outcome|Home-based Training|"After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.~Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.~Home-based training: Home-based exercise training for cardiac patients."
11125905|NCT01732419|OG001|Outcome|Centre-based Training|"Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.~Centre-based training: Usual exercise training in an outpatient setting."
11125906|NCT01732419|EG000|Reported Event|Home-based Training|"After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.~Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.~Home-based training: Home-based exercise training for cardiac patients."
11125907|NCT01732419|EG001|Reported Event|Centre-based Training|"Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.~Centre-based training: Usual exercise training in an outpatient setting."
11125908|NCT01732445|BG000|Baseline|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician's discretion, patients may continue treatment past 6 courses if they are without disease progression.
11125909|NCT01732445|FG000|Participant Flow|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician's discretion, patients may continue treatment past 6 courses if they are without disease progression.
11125910|NCT01732445|OG000|Outcome|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician's discretion, patients may continue treatment past 6 courses if they are without disease progression.
11125911|NCT01732445|EG000|Reported Event|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician's discretion, patients may continue treatment past 6 courses if they are without disease progression.
11125912|NCT01732458|BG000|Baseline|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.
10878789|NCT00454207|OG000|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
10878790|NCT00454207|OG000|Outcome|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
10878791|NCT00454207|EG000|Reported Event|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
11125913|NCT01732458|BG001|Baseline|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125914|NCT01732458|BG002|Baseline|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125915|NCT01732458|BG003|Baseline|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
11125916|NCT01732458|BG004|Baseline|Total|Total of all reporting groups
11125917|NCT01732458|FG000|Participant Flow|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.
11125918|NCT01732458|FG001|Participant Flow|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125919|NCT01732458|FG002|Participant Flow|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125920|NCT01732458|FG003|Participant Flow|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
11125921|NCT01732458|OG000|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
11125922|NCT01732458|OG000|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
11125923|NCT01732458|OG000|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
11125924|NCT01732458|OG000|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
11125925|NCT01732458|OG000|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
11125926|NCT01732458|OG000|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
11125927|NCT01732458|OG000|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
11125928|NCT01732458|OG000|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
11125929|NCT01732458|OG000|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
11125930|NCT01732458|OG000|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
11125931|NCT01732458|OG000|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
11125932|NCT01732458|OG000|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
11125933|NCT01732458|OG000|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125934|NCT01732458|OG001|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125935|NCT01732458|OG002|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125936|NCT01732458|OG003|Outcome|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
11125937|NCT01732458|EG000|Reported Event|Aprepitant 125 mg Adult Equivalent (Dose 1)|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125938|NCT01732458|EG001|Reported Event|Aprepitant 40 mg Adult Equivalent (Dose 2)|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11125939|NCT01732458|EG002|Reported Event|Aprepitant 10 mg Adult Equivalent (Dose 3)|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
11126922|NCT01736254|EG000|Reported Event|Gemfibrozil|Single oral dose of 600 mg gemfibrozil on Day 1.
10878792|NCT00454246|BG000|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
11006864|NCT01088048|EG005|Reported Event|Idelalisib + Ofatumumab|"Participants with CLL received treatments as follows:~Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))"
11006865|NCT01088048|EG006|Reported Event|Idelalisib + Fludarabine|"Participants with CLL received treatments as follows:~Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6"
11006866|NCT01088048|EG007|Reported Event|Idelalisib + Chlorambucil|"Participants with CLL received treatments as follows:~Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11006867|NCT01088048|EG008|Reported Event|Idelalisib + Rituximab + Chlorambucil|"Participants with CLL received treatments as follows:~Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12"
11006868|NCT01088048|EG009|Reported Event|Idelalisib + Rituximab + Lenalidomide|"Participants with CLL and iNHL received treatments as follows:~Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles~Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles"
11006869|NCT01088243|BG000|Baseline|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
11006870|NCT01088243|BG001|Baseline|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
11006871|NCT01088243|BG002|Baseline|Total|Total of all reporting groups
11006872|NCT01088243|FG000|Participant Flow|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
11006873|NCT01088243|FG001|Participant Flow|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
11006874|NCT01088243|OG000|Outcome|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
11006875|NCT01088243|OG001|Outcome|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
11006876|NCT01088243|EG000|Reported Event|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
11006877|NCT01088243|EG001|Reported Event|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
11006878|NCT01088295|BG000|Baseline|Telmisartan|Telmisartan 40mg po daily for 24 weeks
11006879|NCT01088295|FG000|Participant Flow|Telmisartan|Telmisartan 40mg po daily for 24 weeks
11006880|NCT01088295|OG000|Outcome|Telmisartan|Telmisartan 40mg po daily for 24 weeks
11006881|NCT01088295|EG000|Reported Event|Telmisartan|
11006882|NCT01088399|BG000|Baseline|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
11006883|NCT01088399|BG001|Baseline|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
11006884|NCT01088399|BG002|Baseline|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
11006885|NCT01088399|BG003|Baseline|Total|Total of all reporting groups
11006886|NCT01088399|FG000|Participant Flow|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
11006887|NCT01088399|FG001|Participant Flow|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
11006888|NCT01088399|FG002|Participant Flow||It is not known whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
11006889|NCT01088399|OG000|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
11006890|NCT01088399|OG001|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
11006891|NCT01088399|OG002|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
11006892|NCT01088399|EG000|Reported Event|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
11006893|NCT01088399|EG001|Reported Event|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
11125940|NCT01732458|EG003|Reported Event|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
11125941|NCT01732471|BG000|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
11125942|NCT01732471|FG000|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
11125943|NCT01732471|OG000|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
11125944|NCT01732471|EG000|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
11125945|NCT01732484|BG000|Baseline|Cataract Surgery|eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL
11125946|NCT01732484|FG000|Participant Flow|Patients Included|
11125947|NCT01732484|OG000|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
11125948|NCT01732484|OG001|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
11125949|NCT01732484|EG000|Reported Event|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
11125950|NCT01732484|EG001|Reported Event|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
11125951|NCT01732510|BG000|Baseline|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
11125952|NCT01732510|BG001|Baseline|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125953|NCT01732510|BG002|Baseline|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125954|NCT01732510|BG003|Baseline|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125955|NCT01732510|BG004|Baseline|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
11125956|NCT01732510|BG005|Baseline|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125957|NCT01732510|BG006|Baseline|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
11125958|NCT01732510|BG007|Baseline|Total|Total of all reporting groups
11125959|NCT01732510|FG000|Participant Flow|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
11125960|NCT01732510|FG001|Participant Flow|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125961|NCT01732510|FG002|Participant Flow|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125962|NCT01732510|FG003|Participant Flow|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125963|NCT01732510|FG004|Participant Flow|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
11125964|NCT01732510|FG005|Participant Flow|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125965|NCT01732510|FG006|Participant Flow|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
11125966|NCT01732510|OG000|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
11125967|NCT01732510|OG001|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125968|NCT01732510|OG002|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125969|NCT01732510|OG003|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125970|NCT01732510|OG004|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
11125971|NCT01732510|OG005|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125972|NCT01732510|OG006|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
11125973|NCT01732510|OG000|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125974|NCT01732510|OG001|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
11125975|NCT01732510|OG004|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. No participant met criteria for inclusion in the evaluable population.
11125976|NCT01732510|EG000|Reported Event|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125977|NCT01732510|EG001|Reported Event|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125978|NCT01732510|EG002|Reported Event|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125979|NCT01732510|EG003|Reported Event|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125980|NCT01732510|EG004|Reported Event|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
11125981|NCT01732510|EG005|Reported Event|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
11125982|NCT01732510|EG006|Reported Event|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
11006894|NCT01088399|EG002|Reported Event||It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
11006895|NCT01088412|BG000|Baseline|Treated|Treatment with Humatrope for improvement of growth.
11006896|NCT01088412|BG001|Baseline|Untreated|No treatment with Humatrope in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder.
11006897|NCT01088412|BG002|Baseline|Unknown|Treatment with Humatrope unknown.
11006898|NCT01088412|BG003|Baseline|Total|Total of all reporting groups
11006899|NCT01088412|FG000|Participant Flow|Treated|Treatment with Humatrope for improvement of growth. Growth Hormone (GH) product.
11006900|NCT01088412|FG001|Participant Flow|Untreated|No treatment with Humatrope in participants with a history of neoplasia or in those with any short stature homeobox containing gene (SHOX) deficiency-related disorder .
11006901|NCT01088412|FG002|Participant Flow||Treatment with Humatrope unknown.
11006902|NCT01088412|OG000|Outcome|Treated|"Participants treated with somatropin for improvement of growth~Somatropin (recombinant deoxyribonucleic acid [rDNA] origin): Dose, frequency and duration at discretion of attending physician."
11006903|NCT01088412|OG000|Outcome|Treated|"Participants treated with Humatrope for improvement of growth~Humatrope (rDNA origin): Dose, frequency and duration at discretion of attending physician."
11006904|NCT01088412|OG000|Outcome|Treated|"Participants treated with somatropin for improvement of growth~Somatropin (rDNA origin): Dose, frequency and duration at discretion of attending physician."
11006905|NCT01088412|OG000|Outcome|Treated|Participants treated with somatropin for improvement of growth with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
11006906|NCT01088412|OG001|Outcome|Untreated|Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
11006907|NCT01088412|OG002|Outcome|Unknown|Treatment with somatropin unknown.
11006908|NCT01088412|EG000|Reported Event|Treated|Treatment with Humatrope for improvement of growth.
11006909|NCT01088412|EG001|Reported Event|Untreated|No treatment with somatropin in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder.
11006910|NCT01088412|EG002|Reported Event||Treatment with Humatrope unknown.
11006911|NCT01088438|BG000|Baseline|Contextualization Workshop|A four-hour course on contextualization.
11006912|NCT01088438|BG001|Baseline|Control|No intervention
11006913|NCT01088438|BG002|Baseline|Total|Total of all reporting groups
11006914|NCT01088438|FG000|Participant Flow|Contextualization Workshop|A four-hour course on contextualization.
11006915|NCT01088438|FG001|Participant Flow|Control|No intervention
11006916|NCT01088438|OG000|Outcome|Contextualization Workshop|A four-hour course on contextualization.
11006917|NCT01088438|OG001|Outcome|Control|No intervention
11006918|NCT01088438|EG000|Reported Event|Contextualization Workshop|A four-hour course on contextualization.
11006919|NCT01088438|EG001|Reported Event|Control|No intervention
11006920|NCT01088464|BG000|Baseline|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006921|NCT01088464|BG001|Baseline|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006922|NCT01088464|BG002|Baseline|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006923|NCT01088464|BG003|Baseline|Total|Total of all reporting groups
11006924|NCT01088464|FG000|Participant Flow|Cohort 1: Necitumumab|Necitumumab 600 milligrams (mg) administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006925|NCT01088464|FG001|Participant Flow|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006926|NCT01088464|FG002|Participant Flow|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006927|NCT01088464|OG000|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006928|NCT01088464|OG001|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006929|NCT01088464|OG002|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006930|NCT01088464|EG000|Reported Event|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11126923|NCT01736254|EG001|Reported Event|Evacetrapib|Oral doses of 130 mg evacetrapib QD for 10 days (Day 2 through Day 12).
11006931|NCT01088464|EG001|Reported Event|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006932|NCT01088464|EG002|Reported Event|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
11006933|NCT01088503|BG000|Baseline|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
11006934|NCT01088503|BG001|Baseline|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
11006935|NCT01088503|BG002|Baseline|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
11006936|NCT01088503|BG003|Baseline|Total|Total of all reporting groups
11006937|NCT01088503|FG000|Participant Flow|Prasugrel|Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
11006938|NCT01088503|FG001|Participant Flow|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
11006939|NCT01088503|FG002|Participant Flow|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
11006940|NCT01088503|OG000|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
11006941|NCT01088503|OG001|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
11006942|NCT01088503|OG001|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
11006943|NCT01088503|EG000|Reported Event|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
11006944|NCT01088529|BG000|Baseline|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
11006945|NCT01088529|BG001|Baseline|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
11006946|NCT01088529|BG002|Baseline|Total|Total of all reporting groups
11006947|NCT01088529|FG000|Participant Flow|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
11006948|NCT01088529|FG001|Participant Flow|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
11006949|NCT01088529|OG000|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
11006950|NCT01088529|OG001|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
11006951|NCT01088529|EG000|Reported Event|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
11125983|NCT01732536|BG000|Baseline|Treatment|"In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200mcg) once daily"
11125984|NCT01732536|BG001|Baseline|Control|"In-office bilateral sham procedure~Mometasone furoate nasal spray (200mcg) once daily"
11125985|NCT01732536|BG002|Baseline|Total|Total of all reporting groups
11125986|NCT01732536|FG000|Participant Flow|Treatment|In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
11125987|NCT01732536|FG001|Participant Flow|Control|In-office bilateral sham procedure
11125988|NCT01732536|OG000|Outcome|Treatment|"In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200mcg) once daily"
11125989|NCT01732536|OG001|Outcome|Control|"In-office bilateral sham procedure~Mometasone furoate nasal spray (200mcg) once daily"
11125990|NCT01732536|OG000|Outcome|S8 Sinus Implant|"In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200mcg) once daily"
11125991|NCT01732536|OG000|Outcome|S8 Sinus Implant|"Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg)~S8 Sinus Implant: Bilateral in-office placement of S8 sinus implant with 1350 mcg of mometasone furoate and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily"
11125992|NCT01732536|OG001|Outcome|Control|"Bilateral in-office sham procedure in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg)~Sham procedure: Bilateral in-office sham procedure and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily"
11125993|NCT01732536|EG000|Reported Event|Treatment|"In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200mcg) once daily"
11125994|NCT01732536|EG001|Reported Event|Control|"In-office bilateral sham procedure~Mometasone furoate nasal spray (200mcg) once daily"
11125995|NCT01732549|BG000|Baseline|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
11125996|NCT01732549|BG001|Baseline|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
11125997|NCT01732549|BG002|Baseline|Total|Total of all reporting groups
11125998|NCT01732549|FG000|Participant Flow|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
11125999|NCT01732549|FG001|Participant Flow|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
11126000|NCT01732549|OG000|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
11126001|NCT01732549|OG001|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
11126002|NCT01732549|OG000|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
11126003|NCT01732549|EG000|Reported Event|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
11126004|NCT01732549|EG001|Reported Event|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
11126005|NCT01732588|BG000|Baseline|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
11126006|NCT01732588|BG001|Baseline|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A)
11126007|NCT01732588|BG002|Baseline|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
11126008|NCT01732588|BG003|Baseline|Total|Total of all reporting groups
11126009|NCT01732588|FG000|Participant Flow|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
11126010|NCT01732588|FG001|Participant Flow|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A).
11126011|NCT01732588|FG002|Participant Flow|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
11126012|NCT01732588|OG000|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
11126013|NCT01732588|OG001|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
11126014|NCT01732588|OG002|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
11126015|NCT01732588|EG000|Reported Event|Regimen A - 120mg OZ439 PIB|Single oral dose of 120 mg OZ439 as powder in bottle (PIB) formulation.
11126016|NCT01732588|EG001|Reported Event|Regimen B - 120 mg OZ439 IR Caplet|Single oral dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
11126017|NCT01732588|EG002|Reported Event|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate administered orally via the Enterion capsule
11126018|NCT01732640|BG000|Baseline|All Study Participants|Eligible patients will begin with a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126019|NCT01732640|FG000|Participant Flow|20 mg Afatinib|Eligible patients will begin a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126020|NCT01732640|FG001|Participant Flow|30 mg Afatinib|Eligible patients will begin a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126021|NCT01732640|OG000|Outcome|All Study Participants|14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, Eligible patients will begin with a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126022|NCT01732640|OG000|Outcome|All Study Particpants|Eligible patients will begin with a 4-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126023|NCT01732640|OG000|Outcome|20 mg Afatinib|Eligible patients will begin a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126024|NCT01732640|OG001|Outcome|30 mg Afatinib|Eligible patients will begin a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126924|NCT01736254|EG002|Reported Event|Evacetrapib + Gemfibrozil|Oral doses of 600 mg gemfibrozil BID and 130 mg evacetrapib QD for 10 days (Day 13 through Day 22). Single oral dose of 600 mg gemfibrozil on Day 23.
11126925|NCT01736267|BG000|Baseline|Non-NF2 ABI Surgery|Placement of an Auditory Brainstem Implant (ABI) device
11126926|NCT01736267|FG000|Participant Flow|Non-NF2 ABI Surgery|Placement of an Auditory Brainstem Implant (ABI) device
11126025|NCT01732640|OG000|Outcome|Study Arm|"14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.~Afatinib: Afatinib will be supplied as film-coated tablets. Available dosage strengths will be 20, 30, or 40 mg. Tablets will be supplied in HDPE, child-resistant, tamper-evident bottles.~Paclitaxel: Induction chemotherapy: 175 mg/m2 day 1 every 21 days for"
11126026|NCT01732640|OG000|Outcome|All Study Participants|Eligible patients will begin with a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126027|NCT01732640|EG000|Reported Event|20 mg Afatinib|Eligible patients will begin with a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126028|NCT01732640|EG001|Reported Event|30 mg Afatinib|Eligible patients will begin with a 14-day lead-in period with afatinib alone. This will be followed immediately by 2 cycles of induction chemotherapy (IC) with carboplatin AUC 6 IV Day 1, paclitaxel 175mg/m2 IV Day 1, and oral afatinib as a continuous daily dosing. Each cycle is repeated every 21 days. After completion of 2 cycles of IC, patients will be assessed for response by CT/MRI and clinical exam. After the induction, all patients will receive Intensity Modulated Radiation Therapy (IMRT) with weekly cisplatin 40mg/m2 IV. Chemoradiotherapy (CRT) will begin 2-3 weeks after the completion of the second cycle of IC. The patients will be evaluated with a MRI or CT, and FDG PET approximately 12 weeks after completion of CRT.
11126029|NCT01732692|BG000|Baseline|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
11126030|NCT01732692|BG001|Baseline|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
11126031|NCT01732692|BG002|Baseline|Total|Total of all reporting groups
11126032|NCT01732692|FG000|Participant Flow|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
11126033|NCT01732692|FG001|Participant Flow|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
11126034|NCT01732692|OG000|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
11126035|NCT01732692|OG001|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
11126036|NCT01732692|EG000|Reported Event|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
11126037|NCT01732692|EG001|Reported Event|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
11126038|NCT01732718|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Atorvastatin 40 mg or Placebo (matching Atorvastatin 40 mg)
11126039|NCT01732718|FG000|Participant Flow|Atorvastatin, Then Placebo|"Participants first received Atorvastatin 40 mg tablets once daily for 6 weeks. After a washout period of 4 weeks, they then received placebo (matching Atorvastatin 40 mg tablets) once daily for 6 weeks.~Atorvastatin: 40 mg tablet by mouth daily for 6 weeks~Placebo: Matching placebo tablet by mouth daily for 6 weeks"
11126040|NCT01732718|FG001|Participant Flow|Placebo, Then Atorvastatin|"Participants first received Placebo (matching Atorvastatin 40 mg tablets) once daily for 6 weeks. After a washout period of 4 weeks, they then received Atorvastatin 40 mg tablets once daily for 6 weeks.~Atorvastatin: 40 mg tablet by mouth daily for 6 weeks~Placebo: Matching placebo tablet by mouth daily for 6 weeks"
11126041|NCT01732718|OG000|Outcome|Atorvastatin|Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention
11126042|NCT01732718|OG001|Outcome|Placebo|Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention
11126043|NCT01732718|OG000|Outcome|Baseline-Atorvastatin|Participants receiving Atorvastatin 40 mg tablets once daily for 6 weeks
11126044|NCT01732718|OG001|Outcome|Week 4-Atorvastatin|Participants receiving Atorvastatin 40 mg tablets once daily for 6 weeks
11126045|NCT01732718|OG002|Outcome|Week 6-Atorvastatin|Participants receiving Atorvastatin 40 mg tablets once daily for 6 weeks
11126046|NCT01732718|OG003|Outcome|Baseline-Placebo|Participants receiving Placebo once daily for 6 weeks
11126047|NCT01732718|OG004|Outcome|Week 4-Placebo|Participants receiving Placebo once daily for 6 weeks
11126048|NCT01732718|OG005|Outcome|Week 6-Placebo|Participants receiving Placebo once daily for 6 weeks
11126049|NCT01732718|EG000|Reported Event|Atorvastatin|Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention
11126050|NCT01732718|EG001|Reported Event|Placebo|Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention
10845274|NCT00266032|EG002|Reported Event|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
11006952|NCT01088529|EG001|Reported Event|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
11006953|NCT01088646|BG000|Baseline|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
11006954|NCT01088646|FG000|Participant Flow|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
11006955|NCT01088646|OG000|Outcome|Pillcam Express Capsule Delivery System|The delivery system is comprised of three parts: a catheter, a syringe and a capsule holder.
11006956|NCT01088646|OG000|Outcome|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
11006957|NCT01088646|EG000|Reported Event|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
11006958|NCT01088672|BG000|Baseline|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
11006959|NCT01088672|FG000|Participant Flow|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
11006960|NCT01088672|OG000|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
11006961|NCT01088672|EG000|Reported Event|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
11006962|NCT01088711|BG000|Baseline|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
11006963|NCT01088711|BG001|Baseline|T2D Participants (Panel B)|Obese participants with T2D received once-weekly omarigliptin or placebo for 4 weeks.
11006964|NCT01088711|BG002|Baseline|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
11006965|NCT01088711|BG003|Baseline|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
11006966|NCT01088711|BG004|Baseline|Total|Total of all reporting groups
11006967|NCT01088711|FG000|Participant Flow|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
11006968|NCT01088711|FG001|Participant Flow|Healthy - Placebo|Obese healthy participants received once-weekly placebo for 4 weeks.
11006969|NCT01088711|FG002|Participant Flow|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
11006970|NCT01088711|FG003|Participant Flow|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
11006971|NCT01088711|OG000|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
11006972|NCT01088711|OG001|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
11006973|NCT01088711|OG002|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
11006974|NCT01088711|OG003|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
11006975|NCT01088711|OG000|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
11006976|NCT01088711|OG001|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
11006977|NCT01088711|EG000|Reported Event|Omarigliptin 50 mg Healthy (Panel A)|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks.
11006978|NCT01088711|EG001|Reported Event|Placebo Healthy (Panel A)|Obese healthy participants received once-weekly placebo for 4 weeks.
11006979|NCT01088711|EG002|Reported Event|Omarigliptin 50 mg T2D (Panel B)|Obese T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
11006980|NCT01088711|EG003|Reported Event|Placebo T2D (Panel B)|Obese T2D participants received once-weekly placebo for 4 weeks.
11006981|NCT01088984|BG000|Baseline|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
11126051|NCT01732757|BG000|Baseline|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
11126052|NCT01732757|BG001|Baseline|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
11126053|NCT01732757|BG002|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
11126054|NCT01732757|BG003|Baseline|Total|Total of all reporting groups
11126055|NCT01732757|FG000|Participant Flow|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
11126056|NCT01732757|FG001|Participant Flow|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
11126057|NCT01732757|FG002|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
11126058|NCT01732757|OG000|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
11126059|NCT01732757|OG001|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
11126060|NCT01732757|OG002|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
11126061|NCT01732757|EG000|Reported Event|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
11126062|NCT01732757|EG001|Reported Event|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
11126063|NCT01732757|EG002|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
11126064|NCT01732770|BG000|Baseline|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
11126065|NCT01732770|BG001|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
11126066|NCT01732770|BG002|Baseline|Total|Total of all reporting groups
11126067|NCT01732770|FG000|Participant Flow|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
11126068|NCT01732770|FG001|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
11126069|NCT01732770|OG000|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
11126070|NCT01732770|OG001|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
11126071|NCT01732770|EG000|Reported Event|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
11126072|NCT01732770|EG001|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
11126073|NCT01732783|BG000|Baseline|Panitumumab + FOLFOX First-line|Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).
11126074|NCT01732783|BG001|Baseline|Panitumumab + FOLFIRI Second-line|Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).
11126075|NCT01732783|BG002|Baseline|Panitumumab + FOLFIRI First-line|Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
11126076|NCT01732783|BG003|Baseline|Total|Total of all reporting groups
11126077|NCT01732783|FG000|Participant Flow|Panitumumab + FOLFOX First-line|Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).
11126078|NCT01732783|FG001|Participant Flow|Panitumumab + FOLFIRI Second-line|Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).
11126079|NCT01732783|FG002|Participant Flow|Panitumumab + FOLFIRI First-line|Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
11126080|NCT01732783|OG000|Outcome|Panitumumab + FOLFOX First-line|Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).
11126081|NCT01732783|OG001|Outcome|Panitumumab + FOLFIRI Second-line|Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).
11126082|NCT01732783|OG002|Outcome|Panitumumab + FOLFIRI First-line|Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
11126927|NCT01736267|OG000|Outcome|Non-NF2 ABI Surgery|Placement of an Auditory Brainstem Implant (ABI) device
11126083|NCT01732783|EG000|Reported Event|Panitumumab + FOLFOX First-line|Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).
11126084|NCT01732783|EG001|Reported Event|Panitumumab + FOLFIRI Second-line|Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).
11126085|NCT01732783|EG002|Reported Event|Panitumumab + FOLFIRI First-line|Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
11126086|NCT01732796|BG000|Baseline|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
11126087|NCT01732796|BG001|Baseline|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
11126088|NCT01732796|BG002|Baseline|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
11126089|NCT01732796|BG003|Baseline|Total|Total of all reporting groups
11126090|NCT01732796|FG000|Participant Flow|16 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
11126091|NCT01732796|FG001|Participant Flow|24 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
11126092|NCT01732796|FG002|Participant Flow|24 wk CR FDV+DBV+RBV|600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
11126093|NCT01732796|OG000|Outcome|24 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
11126094|NCT01732796|OG001|Outcome|16 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
11126095|NCT01732796|OG000|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
11126096|NCT01732796|OG001|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
11126097|NCT01732796|OG002|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
11126098|NCT01732796|EG000|Reported Event|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
11126099|NCT01732796|EG001|Reported Event|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
11126100|NCT01732796|EG002|Reported Event|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
11126928|NCT01736267|EG000|Reported Event|Non-NF2 ABI Surgery|Placement of an Auditory Brainstem Implant (ABI) device
11126929|NCT01736358|BG000|Baseline|Intranasal Ketoralac|"A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril.~Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery"
11126930|NCT01736358|BG001|Baseline|Placebo|"A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril.~Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery"
11126931|NCT01736358|BG002|Baseline|Total|Total of all reporting groups
11126932|NCT01736358|FG000|Participant Flow|Intranasal Ketoralac|"A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril.~Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery"
11126933|NCT01736358|FG001|Participant Flow|Placebo|"A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril.~Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery"
11126934|NCT01736358|OG000|Outcome|Intranasal Ketoralac|"A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril.~Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery"
11126935|NCT01736358|OG001|Outcome|Placebo|"A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril.~Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery"
11126936|NCT01736358|EG000|Reported Event|Intranasal Ketoralac|"A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril.~Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery"
11126101|NCT04537234|BG000|Baseline|Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
11126102|NCT04537234|BG001|Baseline|Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)|Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
11126103|NCT04537234|BG002|Baseline|Total|Total of all reporting groups
11126104|NCT04537234|FG000|Participant Flow|Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.
11126105|NCT04537234|FG001|Participant Flow|Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)|Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
11126106|NCT04537234|OG000|Outcome|Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
11126107|NCT04537234|OG001|Outcome|Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)|Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
11126108|NCT04537234|EG000|Reported Event|Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
11126109|NCT04537234|EG001|Reported Event|Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)|Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
11126110|NCT04371471|BG000|Baseline|Patient With Covid-19|"Patient with clinical signs of CoV-2-SARS infection and signs of severity~STC-19 score: Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)"
11126111|NCT04371471|FG000|Participant Flow|Patient With Covid-19|"Patient with clinical signs of CoV-2-SARS infection and signs of severity~STC-19 score: Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)"
11126112|NCT04371471|OG000|Outcome|Alive Within 29 Days of Hospitalization|"Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2.~Still living at day 29 after hospitalization"
11126113|NCT04371471|OG001|Outcome|Death Within 29 Days of Hospitalization|"Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2.~Death due to coronavirus disease (COVID-19) was defined as death prior to day 29.~Any deaths from day 29 days onward were considered as death from complications of COVID-19."
11126114|NCT04371471|OG001|Outcome|Death Within 29 Days of Hospitalization|"Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2.~Death due to COVID-19 was defined as death prior to day 29. Any deaths from day 29 days onward were considered as death from complications of COVID-19."
11126115|NCT04371471|EG000|Reported Event|Patient With Covid-19|"Patient with clinical signs of CoV-2-SARS infection and signs of severity~STC-19 score: Score calculated by an algorithm using biomarkers"
11126116|NCT04172701|BG000|Baseline|LAMA|Chronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015.
11126117|NCT04172701|BG001|Baseline|ICS/LABA|Chronic obstructive pulmonary disease (COPD) patients who were prescribed a fixed-dose combination (FDC) of inhaled corticosteroid (ICS)/long-acting beta agonists (LABA) between 01 January 2005 and 30 April 2015.
11126118|NCT04172701|BG002|Baseline|Total|Total of all reporting groups
11126119|NCT04172701|FG000|Participant Flow|LAMA|Chronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015.
11126120|NCT04172701|FG001|Participant Flow|ICS/LABA|Chronic obstructive pulmonary disease (COPD) patients who were prescribed a fixed-dose combination (FDC) of inhaled corticosteroid (ICS)/long-acting beta agonists (LABA) between 01 January 2005 and 30 April 2015.
11126121|NCT04172701|OG000|Outcome|LAMA|Chronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015.
11126122|NCT04172701|OG001|Outcome|ICS/LABA|Chronic obstructive pulmonary disease (COPD) patients who were prescribed a fixed-dose combination (FDC) of inhaled corticosteroid (ICS)/long-acting beta agonists (LABA) between 01 January 2005 and 30 April 2015.
11126123|NCT04172701|EG000|Reported Event|LAMA|"Chronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015.~Participants were matched 1:1 ('LAMA' : 'ICS/LABAs') using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation."
11126124|NCT04172701|EG001|Reported Event|ICS/LABA|"Chronic obstructive pulmonary disease (COPD) patients who were prescribed a fixed-dose combination (FDC) of inhaled corticosteroid (ICS)/long-acting beta agonists (LABA) between 01 January 2005 and 30 April 2015.~Participants were matched 1:1 ('LAMA' : 'ICS/LABAs') using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation."
11126125|NCT03813199|BG000|Baseline|ABX464 50mg + Methotrexate|"Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks~+ methotrexate~ABX464 50mg: ABX464 is a new anti-inflammatory drug~Matching Placebo: placebo matching with ABX464~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126126|NCT03813199|BG001|Baseline|ABX464 100mg + Methotrexate|"Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks~+ methotrexate~ABX464 100mg: ABX464 is a new anti-inflammatory drug~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126127|NCT03813199|BG002|Baseline|Placebo + Methotrexate|"Participants will receive two capsules of matching placebo once daily for 12 weeks~+ methotrexate~Matching Placebo: placebo matching with ABX464~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126128|NCT03813199|BG003|Baseline|Total|Total of all reporting groups
11126129|NCT03813199|FG000|Participant Flow|ABX464 50mg + Methotrexate|"Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks~+ methotrexate~ABX464 50mg: ABX464 is a new anti-inflammatory drug~Matching Placebo: placebo matching with ABX464~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126130|NCT03813199|FG001|Participant Flow|ABX464 100mg + Methotrexate|"Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks~+ methotrexate~ABX464 100mg: ABX464 is a new anti-inflammatory drug~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126131|NCT03813199|FG002|Participant Flow|Placebo + Methotrexate|"Participants will receive two capsules of matching placebo once daily for 12 weeks~+ methotrexate~Matching Placebo: placebo matching with ABX464~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126132|NCT03813199|OG000|Outcome|ABX464 50mg + Methotrexate|"Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks~+ methotrexate~ABX464 50mg: ABX464 is a new anti-inflammatory drug~Matching Placebo: placebo matching with ABX464~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126133|NCT03813199|OG001|Outcome|ABX464 100mg + Methotrexate|"Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks~+ methotrexate~ABX464 100mg: ABX464 is a new anti-inflammatory drug~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126134|NCT03813199|OG002|Outcome|Placebo + Methotrexate|"Participants will receive two capsules of matching placebo once daily for 12 weeks~+ methotrexate~Matching Placebo: placebo matching with ABX464~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126135|NCT03813199|EG000|Reported Event|ABX464 50mg + Methotrexate|"Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks~+ methotrexate~ABX464 50mg: ABX464 is a new anti-inflammatory drug~Matching Placebo: placebo matching with ABX464~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126136|NCT03813199|EG001|Reported Event|ABX464 100mg + Methotrexate|"Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks~+ methotrexate~ABX464 100mg: ABX464 is a new anti-inflammatory drug~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126137|NCT03813199|EG002|Reported Event|Placebo + Methotrexate|"Participants will receive two capsules of matching placebo once daily for 12 weeks~+ methotrexate~Matching Placebo: placebo matching with ABX464~Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study"
11126937|NCT01736358|EG001|Reported Event|Placebo|"A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril.~Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery"
11126938|NCT01736397|BG000|Baseline|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
11126939|NCT01736397|BG001|Baseline|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
11126940|NCT01736397|BG002|Baseline|Total|Total of all reporting groups
11126941|NCT01736397|FG000|Participant Flow|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
11126942|NCT01736397|FG001|Participant Flow|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
11126943|NCT01736397|OG000|Outcome|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
11126944|NCT01736397|OG001|Outcome|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
11126945|NCT01736397|EG000|Reported Event|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
11126946|NCT01736397|EG001|Reported Event|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
11126947|NCT01736475|BG000|Baseline|Prophylaxis|
11126948|NCT01736475|BG001|Baseline|On-demand|
11126949|NCT01736475|BG002|Baseline|Total|Total of all reporting groups
11126950|NCT01736475|FG000|Participant Flow|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
11126951|NCT01736475|FG001|Participant Flow|On-demand|10 to 60 ± 5 IU/kg
11126952|NCT01736475|OG000|Outcome|Prophylaxis|
11126953|NCT01736475|OG001|Outcome|On-demand|
11126954|NCT01736475|OG000|Outcome|Participants With a Bleeding Episode|All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens.
11126955|NCT01736475|OG000|Outcome|Prophylaxis|Break-through bleeds during prophylaxis
11126956|NCT01736475|OG000|Outcome|All Study Participants|
11126957|NCT01736475|OG000|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
11126958|NCT01736475|OG000|Outcome|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
11126959|NCT01736475|OG001|Outcome|On-demand|10 to 60 ± 5 IU/kg
11126960|NCT01736475|OG000|Outcome|Prophylaxis|Participants with both baseline and study completion HAEMO-SYM scores
11126961|NCT01736475|OG001|Outcome|On-demand|Participants with both baseline and study completion HAEMO-SYM scores
11126138|NCT03478956|BG000|Baseline|Etrolizumab Q4W|Etrolizumab 1.5 milligrams per kilogram of body weight (mg/kg) was administered by subcutaneous (SC) injection once every 4 weeks (Q4W) for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment period plus 8-week safety follow-up). Participants were then given the option to participate in the 312-week open-label extension (OLE) treatment phase with etrolizumab 1.5 mg/kg SC Q4W followed by the 104-week safety surveillance phase (no etrolizumab treatment) to monitor for progressive multifocal leukoencephalopathy (PML). All participants who chose not to enter the OLE phase after the 24-week randomized treatment phase entered the 104-week PML monitoring phase.
11126139|NCT03478956|BG001|Baseline|Etrolizumab Q8W|Etrolizumab 3.0 mg/kg was administered by subcutaneous (SC) injection once every 8 weeks (Q8W) for a total of 2 doses. Participants were then given the option to participate in the 312-week open-label extension (OLE) treatment phase with etrolizumab 1.5 mg/kg SC Q4W followed by the 104-week safety surveillance phase (no etrolizumab treatment) to monitor for progressive multifocal leukoencephalopathy (PML). All participants who chose not to enter the OLE phase after the 24-week randomized treatment phase entered the 104-week PML monitoring phase.
11126140|NCT03478956|BG002|Baseline|Total|Total of all reporting groups
11126141|NCT03478956|FG000|Participant Flow|Etrolizumab Q4W|Etrolizumab 1.5 milligrams per kilogram of body weight (mg/kg) was administered by subcutaneous (SC) injection once every 4 weeks (Q4W) for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment period plus 8-week safety follow-up). Participants were then given the option to participate in the 312-week open-label extension (OLE) treatment phase with etrolizumab 1.5 mg/kg SC Q4W followed by the 104-week safety surveillance phase (no etrolizumab treatment) to monitor for progressive multifocal leukoencephalopathy (PML). All participants who chose not to enter the OLE phase after the 24-week randomized treatment phase entered the 104-week PML monitoring phase.
11126142|NCT03478956|FG001|Participant Flow|Etrolizumab Q8W|Etrolizumab 3.0 mg/kg was administered by subcutaneous (SC) injection once every 8 weeks (Q8W) for a total of 2 doses. Participants were then given the option to participate in the 312-week open-label extension (OLE) treatment phase with etrolizumab 1.5 mg/kg SC Q4W followed by the 104-week safety surveillance phase (no etrolizumab treatment) to monitor for progressive multifocal leukoencephalopathy (PML). All participants who chose not to enter the OLE phase after the 24-week randomized treatment phase entered the 104-week PML monitoring phase.
11126143|NCT03478956|OG000|Outcome|Etrolizumab Q4W|Etrolizumab 1.5 milligrams per kilogram of body weight (mg/kg) was administered by subcutaneous (SC) injection once every 4 weeks (Q4W) for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment period plus 8-week safety follow-up). Participants were then given the option to participate in the 312-week open-label extension (OLE) treatment phase with etrolizumab 1.5 mg/kg SC Q4W followed by the 104-week safety surveillance phase (no etrolizumab treatment) to monitor for progressive multifocal leukoencephalopathy (PML). All participants who chose not to enter the OLE phase after the 24-week randomized treatment phase entered the 104-week PML monitoring phase.
11126144|NCT03478956|OG001|Outcome|Etrolizumab Q8W|Etrolizumab 3.0 mg/kg was administered by subcutaneous (SC) injection once every 8 weeks (Q8W) for a total of 2 doses. Participants were then given the option to participate in the 312-week open-label extension (OLE) treatment phase with etrolizumab 1.5 mg/kg SC Q4W followed by the 104-week safety surveillance phase (no etrolizumab treatment) to monitor for progressive multifocal leukoencephalopathy (PML). All participants who chose not to enter the OLE phase after the 24-week randomized treatment phase entered the 104-week PML monitoring phase.
11126145|NCT03478956|EG000|Reported Event|Etrolizumab Q4W|Etrolizumab 1.5 milligrams per kilogram of body weight (mg/kg) was administered by subcutaneous (SC) injection once every 4 weeks (Q4W) for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment period plus 8-week safety follow-up). Participants were then given the option to participate in the 312-week open-label extension (OLE) treatment phase with etrolizumab 1.5 mg/kg SC Q4W followed by the 104-week safety surveillance phase (no etrolizumab treatment) to monitor for progressive multifocal leukoencephalopathy (PML). All participants who chose not to enter the OLE phase after the 24-week randomized treatment phase entered the 104-week PML monitoring phase.
11126146|NCT03478956|EG001|Reported Event|Etrolizumab Q8W|Etrolizumab 3.0 mg/kg was administered by subcutaneous (SC) injection once every 8 weeks (Q8W) for a total of 2 doses. Participants were then given the option to participate in the 312-week open-label extension (OLE) treatment phase with etrolizumab 1.5 mg/kg SC Q4W followed by the 104-week safety surveillance phase (no etrolizumab treatment) to monitor for progressive multifocal leukoencephalopathy (PML). All participants who chose not to enter the OLE phase after the 24-week randomized treatment phase entered the 104-week PML monitoring phase.
11126147|NCT03348930|BG000|Baseline|Tolcapone/Placebo|"Each subject will have a 4 week treatment phase with Tolcapone and a 4 week placebo phase before or after Tolcapone phase depending on randomization.~Tolcapone 200 MG: All eligible study subjects will go through a 2-week treatment phase during which they will begin tolcapone at 100mg twice a day."
11126148|NCT03348930|FG000|Participant Flow|Tolcapone, Then Placebo|Each subject will have a 2 week active treatment phase first with Tolcapone (100mg, twice a day), followed by a one-week washout period, followed by a 2 week treatment phase with a Tolcapone-matched placebo tablet.
11126149|NCT03348930|FG001|Participant Flow|Placebo, Then Tolcapone|Each subject will have a 2 week active treatment phase first with a Tolcapone-matched placebo, followed by a one-week washout period, followed by a 2 week active treatment phase with Tolcapone (100mg, twice a day).
11126150|NCT03348930|OG000|Outcome|Tolcapone|Tolcapone 200 MG: All eligible study subjects will go through a 2-week treatment phase (either during the first two weeks or last two weeks of the study) during which they will begin tolcapone at 100mg twice a day.
11126151|NCT03348930|OG001|Outcome|Placebo|All eligible study subjects will go through a 2-week phase (either during the first two weeks or last two weeks of the study) during which they will begin the tolcapone-matched placebo twice a day.
11126152|NCT03348930|EG000|Reported Event|Tolcapone|Subjects received 100mg of tolcapone twice a day for two weeks either starting after the baseline visit, or starting after the 1-week washout period.
11126153|NCT03348930|EG001|Reported Event|Placebo|Subjects received tolcapone-matched placebo twice a day for two weeks either starting after the baseline visit, or starting after the 1-week washout period.
11126154|NCT03282240|BG000|Baseline|High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
11126155|NCT03282240|BG001|Baseline|High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)|Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
11126156|NCT03282240|BG002|Baseline|High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)|Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
11126157|NCT03282240|BG003|Baseline|Total|Total of all reporting groups
11126158|NCT03282240|FG000|Participant Flow|High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants randomized to receive a single injection of 0.7 mL high dose quadrivalent influenza vaccine (QIV-HD) by intramuscular (IM) route at Day 0.
11126159|NCT03282240|FG001|Participant Flow|High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)|Participants randomized to receive a single injection of 0.5 mL licensed high dose trivalent influenza vaccine (TIV-HD1) by IM route at Day 0.
11126160|NCT03282240|FG002|Participant Flow|High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)|Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0.
11126161|NCT03282240|OG000|Outcome|High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
11126162|NCT03282240|OG001|Outcome|High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)|Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
11126163|NCT03282240|OG002|Outcome|High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)|Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
11126164|NCT03282240|OG003|Outcome|High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)|Participants randomized to receive either a single injection of 0.5 mL licensed TIV-HD1 or investigational TIV-HD2 by IM route at Day 0.
11126165|NCT03282240|OG002|Outcome|High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)|Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0.
11126166|NCT03282240|OG000|Outcome|High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.
11126167|NCT03282240|EG000|Reported Event|High-Dose Quadrivalent Influenza Vaccine (QIV-HD)|Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.
11126168|NCT03282240|EG001|Reported Event|High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)|Participants randomized to receive a single injection of the licensed high dose TIV-HD1 by IM route at Day 0.
11126169|NCT03282240|EG002|Reported Event|High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)|Participants randomized to receive a single injection of the investigational TIV-HD2 by IM route at Day 0.
11126170|NCT03260868|BG000|Baseline|Virtual|Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.
11126171|NCT03260868|BG001|Baseline|Traditional|Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
11126172|NCT03260868|BG002|Baseline|Total|Total of all reporting groups
11126173|NCT03260868|FG000|Participant Flow|Virtual|Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.
11126174|NCT03260868|FG001|Participant Flow|Traditional|Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
11126175|NCT03260868|OG000|Outcome|Virtual|Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.
11126176|NCT03260868|OG001|Outcome|Traditional|Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
11126177|NCT03260868|EG000|Reported Event|Virtual|Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.
11126178|NCT03260868|EG001|Reported Event|Traditional|Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
11126179|NCT03245580|BG000|Baseline|Arm 1 -Modified Wet Suction|"Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction~Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease."
11126180|NCT03245580|BG001|Baseline|Arm 2- Slow Pull|"Intervention: Procedure Core Liver Biopsy Technique: Slow Pull~Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease."
11126181|NCT03245580|BG002|Baseline|Total|Total of all reporting groups
11126182|NCT03245580|FG000|Participant Flow|Arm 1 -Modified Wet Suction|"Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction~Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease."
11126183|NCT03245580|FG001|Participant Flow|Arm 2- Slow Pull|"Intervention: Procedure Core Liver Biopsy Technique: Slow Pull~Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease."
11126184|NCT03245580|OG000|Outcome|Arm 1 -Modified Wet Suction|"Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction~Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease."
11126962|NCT01736475|OG000|Outcome|Prophylaxis|Participants with both baseline and study completion SF-36 Scores
11126185|NCT03245580|OG001|Outcome|Arm 2- Slow Pull|"Intervention: Procedure Core Liver Biopsy Technique: Slow Pull~Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease."
11126186|NCT03245580|EG000|Reported Event|Arm 1 -Modified Wet Suction|"Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction~Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease."
11126187|NCT03245580|EG001|Reported Event|Arm 2- Slow Pull|"Intervention: Procedure Core Liver Biopsy Technique: Slow Pull~Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease."
11126188|NCT03157037|BG000|Baseline|Imlifidase|"IdeS intravenous infusion 0.25 mg/kg body weight (BW) intravenous infusion~HMed-IdeS: One dose of 0.25 mg/kg BW HMed-IdeS on study day 1"
11126189|NCT03157037|FG000|Participant Flow|Treatment HMed-IdeS|A single dose of IdeS (imlifidase) 0.25 mg/kg body weight (BW) intravenous infusion on study Day 1
11126190|NCT03157037|OG000|Outcome|Dialysis Dependent at Baseline|Patients who were dialysis dependent at baseline
11126191|NCT03157037|OG001|Outcome|Dialysis Independent at Baseline|Patients who were dialysis independent at baseline
11126192|NCT03157037|OG002|Outcome|All Patients|All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
11126193|NCT03157037|OG000|Outcome|All Patients|All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
11126194|NCT03157037|OG002|Outcome|All Patients|All patients irrespective of dialysis dependency at baseline and at 6 months
11126195|NCT03157037|OG002|Outcome|All Patients|All patients irrespective of dialysis dependency at baseline
11126196|NCT03157037|OG000|Outcome|All Patients|All patients (i.e., irrespective of dialysis dependency at baseline)
11126197|NCT03157037|OG000|Outcome|14 Biopsies Collected From 10 Patients in the Study|10 biopsies were collected before imlifidase administration and 4 biopsies were collected after imlifidase administration
11126198|NCT03157037|EG000|Reported Event|Safety Analysis Set|All patients who have received imlifidase.
11126199|NCT03143218|BG000|Baseline|SMC With SP+AQ|"Administration of RABIPUR® in Year 1 and Hepatitis A vaccine in Year 2 and 3, followed by 4 cycles of SMC with sulphadoxine/pyrimethamine plus amodiaquine in Year 1,2 and 3.~RABIPUR®: Year 1 (2017) Three doses of rabies vaccine (April, May, June) Year 2 and 3 (2018/19) One dose of Hepatitis A vaccine (June)~SMC with SP+AQ: Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses."
11126200|NCT03143218|BG001|Baseline|RTS,S/AS01|"Administration of the malaria vaccine RTS,S/AS01 followed by 4 cycles of SMC with placebo in Year 1,2 and 3.~RTS,S/AS01: Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)~SMC placebo: Year 1, 2 and 3(2017/18/19) Four cycles of SMC placebo during the malaria transmission season"
11126201|NCT03143218|BG002|Baseline|RTS,S/AS01 PLUS SMC With SP+AQ|"Administration of the malaria vaccine RTS,S/AS01 followed by 4 cycles of SMC with sulphadoxine/pyrimethamine plus amodiaquine in Year 1,2 and 3.~RTS,S/AS01: Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)~SMC with SP+AQ: Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses."
11126202|NCT03143218|BG003|Baseline|Total|Total of all reporting groups
11126203|NCT03143218|FG000|Participant Flow|SMC With SP+AQ|"Administration of RABIPUR® in Year 1 and Hepatitis A vaccine in Year 2 and 3, followed by 4 cycles of SMC with sulphadoxine/pyrimethamine plus amodiaquine in Year 1,2 and 3.~RABIPUR®: Year 1 (2017) Three doses of rabies vaccine (April, May, June) Year 2 and 3 (2018/19) One dose of Hepatitis A vaccine (June)~SMC with SP+AQ: Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses."
11126204|NCT03143218|FG001|Participant Flow|RTS,S/AS01|"Administration of the malaria vaccine RTS,S/AS01 followed by 4 cycles of SMC with placebo in Year 1,2 and 3.~RTS,S/AS01: Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)~SMC placebo: Year 1, 2 and 3(2017/18/19) Four cycles of SMC placebo during the malaria transmission season"
11126205|NCT03143218|FG002|Participant Flow|RTS,S/AS01 PLUS SMC With SP+AQ|"Administration of the malaria vaccine RTS,S/AS01 followed by 4 cycles of SMC with sulphadoxine/pyrimethamine plus amodiaquine in Year 1,2 and 3.~RTS,S/AS01: Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)~SMC with SP+AQ: Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses."
11126206|NCT03143218|OG000|Outcome|SMC With SP+AQ|"Administration of RABIPUR® in Year 1 and Hepatitis A vaccine in Year 2 and 3, followed by 4 cycles of SMC with sulphadoxine/pyrimethamine plus amodiaquine in Year 1,2 and 3.~RABIPUR®: Year 1 (2017) Three doses of rabies vaccine (April, May, June) Year 2 and 3 (2018/19) One dose of Hepatitis A vaccine (June)~SMC with SP+AQ: Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses."
11126207|NCT03143218|OG001|Outcome|RTS,S/AS01|"Administration of the malaria vaccine RTS,S/AS01 followed by 4 cycles of SMC with placebo in Year 1,2 and 3.~RTS,S/AS01: Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)~SMC placebo: Year 1, 2 and 3(2017/18/19) Four cycles of SMC placebo during the malaria transmission season"
11126963|NCT01736475|OG001|Outcome|On-demand|Participants with both baseline and study completion SF-36 Scores
11126964|NCT01736475|OG000|Outcome|Pharmacokinetic Analysis Participants|
11126965|NCT01736475|OG001|Outcome|On-deamand|
11126208|NCT03143218|OG002|Outcome|RTS,S/AS01 PLUS SMC With SP+AQ|"Administration of the malaria vaccine RTS,S/AS01 followed by 4 cycles of SMC with sulphadoxine/pyrimethamine plus amodiaquine in Year 1,2 and 3.~RTS,S/AS01: Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)~SMC with SP+AQ: Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses."
11126209|NCT03143218|EG000|Reported Event|SMC With SP+AQ|"Administration of RABIPUR® in Year 1 and Hepatitis A vaccine in Year 2 and 3, followed by 4 cycles of SMC with sulphadoxine/pyrimethamine plus amodiaquine in Year 1,2 and 3.~RABIPUR®: Year 1 (2017) Three doses of rabies vaccine (April, May, June) Year 2 and 3 (2018/19) One dose of Hepatitis A vaccine (June)~SMC with SP+AQ: Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses."
11126210|NCT03143218|EG001|Reported Event|RTS,S/AS01|"Administration of the malaria vaccine RTS,S/AS01 followed by 4 cycles of SMC with placebo in Year 1,2 and 3.~RTS,S/AS01: Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)~SMC placebo: Year 1, 2 and 3(2017/18/19) Four cycles of SMC placebo during the malaria transmission season"
11126211|NCT03143218|EG002|Reported Event|RTS,S/AS01 PLUS SMC With SP+AQ|"Administration of the malaria vaccine RTS,S/AS01 followed by 4 cycles of SMC with sulphadoxine/pyrimethamine plus amodiaquine in Year 1,2 and 3.~RTS,S/AS01: Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)~SMC with SP+AQ: Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses."
11126212|NCT03128931|BG000|Baseline|Test Group|"The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .~Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor."
11126213|NCT03128931|FG000|Participant Flow|Test Group|"The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .~Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor."
11126214|NCT03128931|OG000|Outcome|Test Group|"The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .~Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor."
11126215|NCT03128931|EG000|Reported Event|Test Group|"The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .~Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor."
11126966|NCT01736475|EG000|Reported Event|All Study Participants|All study participants were analyzed in a single arm/group.
11126967|NCT01736527|BG000|Baseline|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
11126968|NCT01736527|FG000|Participant Flow|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
11126969|NCT01736527|OG000|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
11126970|NCT01736527|EG000|Reported Event|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
11126971|NCT01736540|BG000|Baseline|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
11126972|NCT01736540|FG000|Participant Flow|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
11126973|NCT01736540|OG000|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
11126974|NCT01736540|OG001|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
11126975|NCT01736540|OG002|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
11126976|NCT01736540|OG003|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
11126977|NCT01736540|OG004|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
11126978|NCT01736540|EG000|Reported Event|Thalassaemia Major|Subset of overall participants with thalassemia major
11126979|NCT01736540|EG001|Reported Event|Myelodysplastic Syndrome (MDS)|Subset of overall participants with MDS
11126980|NCT01736540|EG002|Reported Event|Other Anaemia|Subset of overall participants with other types of anaemias
11126981|NCT01736540|EG003|Reported Event|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
11126982|NCT01736553|BG000|Baseline|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
11126983|NCT01736553|BG001|Baseline|Healthy Controls|Healthy control infants
11126984|NCT01736553|BG002|Baseline|Total|Total of all reporting groups
11126985|NCT01736553|FG000|Participant Flow|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
11126986|NCT01736553|FG001|Participant Flow|Healthy Controls|Healthy control infants
11126987|NCT01736553|OG000|Outcome|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
11126988|NCT01736553|OG001|Outcome|Healthy Controls|Healthy control infants
11126989|NCT01736553|OG000|Outcome|Correlation With TIMPSI|
11126990|NCT01736553|OG001|Outcome|Correlation With CHOP-INTEND|
11126991|NCT01736553|OG000|Outcome|Correlation With CHOP-INTEND|
11126992|NCT01736553|OG001|Outcome|Correlation With TIMPSI|
11126216|NCT02498392|BG000|Baseline|Placebo|All participants received matching placebo tablets orally once daily (qd) during the double blind lead-in period. Participants were then assessed for response according to criteria based on reduction from lead-in baseline in Hamilton depression rating scale (HDRS17) and continued to receive adjunctive matching placebo tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126217|NCT02498392|BG001|Baseline|JNJ-42165279 25 mg|Participants receiving matching placebo tablets during the double blind lead-in period were randomized to receive JNJ-42165279 25 milligrams (mg) tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126218|NCT02498392|BG002|Baseline|Total|Total of all reporting groups
11126219|NCT02498392|FG000|Participant Flow|Placebo|All participants received matching placebo tablets orally once daily (qd) during the double blind lead-in period. Participants were then assessed for response according to criteria based on reduction from lead-in baseline in Hamilton depression rating scale (HDRS17) and continued to receive adjunctive matching placebo tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126220|NCT02498392|FG001|Participant Flow|JNJ-42165279 25 mg|Participants receiving matching placebo tablets during the double blind lead-in period were randomized to receive JNJ-42165279 25 milligrams (mg) tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126221|NCT02498392|OG000|Outcome|Placebo|All participants received matching placebo tablets orally once daily (qd) during the double blind lead-in period. Participants were then assessed for response according to criteria based on reduction from lead-in baseline in Hamilton depression rating scale (HDRS17) and continued to receive adjunctive matching placebo tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126222|NCT02498392|OG001|Outcome|JNJ-42165279 25 mg|Participants receiving matching placebo tablets during the double blind lead-in period were randomized to receive JNJ-42165279 25 milligrams (mg) tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126223|NCT02498392|OG000|Outcome|JNJ-42165279 25 mg|Participants receiving matching placebo tablets during the double blind lead-in period were randomized to receive JNJ-42165279 25 milligrams (mg) tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126224|NCT02498392|EG000|Reported Event|Double-blind (DB) Lead-in Period: Placebo|All participants received matching placebo tablets orally once daily (qd) during the double blind lead-in period.
11126225|NCT02498392|EG001|Reported Event|DB Treatment + Withdrawal Period: Placebo|All participants received matching placebo tablets orally qd during the double blind lead-in period. Participants were then assessed for response according to criteria based on reduction from lead-in baseline in Hamilton depression rating scale (HDRS17) and continued to receive adjunctive matching placebo tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126226|NCT02498392|EG002|Reported Event|DB Treatment + Withdrawal Period: JNJ-42165279 25 mg|Participants receiving matching placebo tablets during the double blind lead-in period were randomized to receive JNJ-42165279 25 milligrams (mg) tablets orally qd for 6 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period prior to Week 11 entered the withdrawal period and were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific participant.
11126227|NCT02478775|BG000|Baseline|Experimental: Frequent Blood Sampling, Degarelix|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.~BMI = 18.5 to 24.9 BMI"
11126228|NCT02478775|BG001|Baseline|Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.~Normal weight participants = 18.5 to 24.9 BMI"
10845293|NCT00266279|BG000|Baseline|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
11126229|NCT02478775|BG002|Baseline|Experimental: Frequent Blood Sampling, Cetrorelix: Obese|"Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.~Obese participants = BMI of >30"
11126230|NCT02478775|BG003|Baseline|Total|Total of all reporting groups
11007964|NCT01093885|EG000|Reported Event|Open Label: Medication Ambrisentan|"Open label study of Ambrisentan.~Ambrisentan will begin at 5mg daily for the first month.~Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week. Subjects will continue their present dose and schedule of disease modifying/antifibrotic medication for the duration of the study.~Ambrisentan: Drug is dispensed in tablet form. Ambrisentan with anti-fibrotic to assess benefit on skin~Dosing of ambrisentan will begin at 5mg daily for the first month. Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week."
11007965|NCT01093976|BG000|Baseline|Dronabinol|Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
11007966|NCT01093976|FG000|Participant Flow|Dronabinol|Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
11007967|NCT01093976|OG000|Outcome|Dronabinol|Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
11007968|NCT01093976|EG000|Reported Event|Dronabinol|Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
11007969|NCT01094106|BG000|Baseline|Ropivacaine 0,75%|"Patients undergoing caesarean section under spinal anaesthesia~Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h"
11007970|NCT01094106|BG001|Baseline|NaCl 0,9%|"Patients undergoing caesarean section under spinal anaesthesia~NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h"
11007971|NCT01094106|BG002|Baseline|Total|Total of all reporting groups
11007972|NCT01094106|FG000|Participant Flow|Ropivacaine 0,75%|"Postoperative wound infusion 15 mg /h / 48h~Ropivacaine 0,75%: Postoperative wound infusion 2 ml/ h/ 48h"
11007973|NCT01094106|FG001|Participant Flow|NaCl 0,9%|"Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h~NaCl 0,9%: Postoperative wound infusion 2 ml/h/48h"
11007974|NCT01094106|OG000|Outcome|Ropivacaine 0,75%|"Patients undergoing caesarean section under spinal anaesthesia~Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h"
11007975|NCT01094106|OG001|Outcome|NaCl 0,9%|"Patients undergoing caesarean section under spinal anaesthesia~NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h"
11007976|NCT01094106|EG000|Reported Event|Ropivacaine 0,75%|"Patients undergoing caesarean section under spinal anaesthesia~Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h"
11007977|NCT01094106|EG001|Reported Event|NaCl 0,9%|"Patients undergoing caesarean section under spinal anaesthesia~NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h"
11007978|NCT01094119|BG000|Baseline|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
11007979|NCT01094119|BG001|Baseline|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
11007980|NCT01094119|BG002|Baseline|Total|Total of all reporting groups
10848980|NCT00293202|OG000|Outcome|Etanercept|"Active comparator: Etanercept 25 mg injection twice a week~Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week for a total of 52 weeks."
11007981|NCT01094119|FG000|Participant Flow|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
11007982|NCT01094119|FG001|Participant Flow|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
11007983|NCT01094119|OG000|Outcome|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
11007984|NCT01094119|OG001|Outcome|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
11007985|NCT01094119|EG000|Reported Event|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
11007986|NCT01094119|EG001|Reported Event|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
11007987|NCT01094171|BG000|Baseline|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
11007988|NCT01094171|FG000|Participant Flow|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
11007989|NCT01094171|OG000|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
11007990|NCT01094171|EG000|Reported Event|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
11007991|NCT01094184|BG000|Baseline|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
11007992|NCT01094184|BG001|Baseline|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
11007993|NCT01094184|BG002|Baseline|Total|Total of all reporting groups
11007994|NCT01094184|FG000|Participant Flow|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
11127009|NCT01736566|BG000|Baseline|Family History + Whole Genome Sequencing: Primary Care|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator, in the Extension phase of the study all participants are in the Experimental Arm."
11127010|NCT01736566|BG001|Baseline|Family History Only: Primary Care|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Standard of Care Only: Doctors and their patients receive a Family History report only"
11127011|NCT01736566|BG002|Baseline|Family History + Whole Genome Sequencing - Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator, in the Extension phase of the study all participants are in the Experimental Arm."
11127012|NCT01736566|BG003|Baseline|Family History Only: Cardiology|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Family History Only: Doctors and their patients receive a Family History report only"
11127013|NCT01736566|BG004|Baseline|Extension Cohort|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~In the main study, participants are randomized between Experimental and Comparator. For the Extension cohort, all participants receive whole genome sequencing."
11127014|NCT01736566|BG005|Baseline|Total|Total of all reporting groups
11127015|NCT01736566|FG000|Participant Flow|Family History + Whole Genome Sequencing: Primary Care|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Standard of Care + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient."
11127016|NCT01736566|FG001|Participant Flow|Family History Only: Primary Care|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Standard of Care Only: Doctors and their patients receive a Family History report only"
11127017|NCT01736566|FG002|Participant Flow|Family History + Whole Genome Sequencing: Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator, in the Extension phase of the study all participants are in the Experimental Arm."
11127018|NCT01736566|FG003|Participant Flow|Family History Only: Cardiology|Doctors and their patients receive an Annotated Family History Report only. Active Comparator: Family History Only: Doctors and their patients receive a Family History report only
11127019|NCT01736566|FG004|Participant Flow|Extension Cohort|"Family History + Whole Genome Sequencing (Genome Report): Doctors and their African American patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient."
11127020|NCT01736566|OG000|Outcome|Family History + Whole Genome Sequencing: Primary Care|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator, in the Extension phase of the study all participants are in the Experimental Arm."
11127021|NCT01736566|OG001|Outcome|Family History Only: Primary Care|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Standard of Care Only: Doctors and their patients receive a Family History report only"
10848981|NCT00293202|OG001|Outcome|Placebo|"No Drug: Saline injection twice a week~Hemodialysis patients will receive Saline by subcutaneous injection twice a week for a total of 52 weeks"
11007995|NCT01094184|FG001|Participant Flow|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
11007996|NCT01094184|OG000|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
11007997|NCT01094184|OG001|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
11007998|NCT01094184|EG000|Reported Event|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
11007999|NCT01094184|EG001|Reported Event|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
11008000|NCT01094288|BG000|Baseline|Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 10 mg, enteric-coated tablets (ECT), orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 28 cycles, or until the occurrence of PD, unmanageable adverse events (AEs) or withdrawal of consent.
11008001|NCT01094288|BG001|Baseline|Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008002|NCT01094288|BG002|Baseline|Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008003|NCT01094288|BG003|Baseline|Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008004|NCT01094288|BG004|Baseline|Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008005|NCT01094288|BG005|Baseline|Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008006|NCT01094288|BG006|Baseline|Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008007|NCT01094288|BG007|Baseline|Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF|Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008008|NCT01094288|BG008|Baseline|Total|Total of all reporting groups
11008009|NCT01094288|FG000|Participant Flow|Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 10 mg, enteric-coated tablets (ECT), orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 28 cycles, or until the occurrence of PD, unmanageable adverse events (AEs) or withdrawal of consent.
11008010|NCT01094288|FG001|Participant Flow|Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008011|NCT01094288|FG002|Participant Flow|Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008012|NCT01094288|FG003|Participant Flow|Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008013|NCT01094288|FG004|Participant Flow|Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008014|NCT01094288|FG005|Participant Flow|Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008015|NCT01094288|FG006|Participant Flow|Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008016|NCT01094288|FG007|Participant Flow|Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF|Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008017|NCT01094288|OG000|Outcome|Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 10 mg, enteric-coated tablets (ECT), orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 28 cycles, or until the occurrence of PD, unmanageable adverse events (AEs) or withdrawal of consent.
11008018|NCT01094288|OG001|Outcome|Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008019|NCT01094288|OG002|Outcome|Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008020|NCT01094288|OG003|Outcome|Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008021|NCT01094288|OG004|Outcome|Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008022|NCT01094288|OG005|Outcome|Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008023|NCT01094288|OG006|Outcome|Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008024|NCT01094288|OG007|Outcome|Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF|Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008025|NCT01094288|OG000|Outcome|Alisertib 10 mg|Alisertib 10 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 of each cycle (21-day cycle).
11008026|NCT01094288|OG001|Outcome|Alisertib 20 mg|Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2.
11008027|NCT01094288|OG002|Outcome|Alisertib 30 mg|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2. Assessment was performed on Day 5 if alisertib was given on a 5 day schedule.
11008028|NCT01094288|OG003|Outcome|Alisertib 40 mg|Alisertib 40 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2. Assessment was performed on Day 5 if alisertib was given on a 5 day schedule.
11008029|NCT01094288|EG000|Reported Event|Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 10 mg, enteric-coated tablets (ECT), orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 28 cycles, or until the occurrence of PD, unmanageable adverse events (AEs) or withdrawal of consent.
11127022|NCT01736566|OG002|Outcome|Family History + Whole Genome Sequencing - Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator Arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127023|NCT01736566|OG003|Outcome|Family History Only: Cardiology|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Standard of Care Only: Doctors and their patients receive a Family History report only"
11127024|NCT01736566|OG004|Outcome|Extension Cohort|"Family History + Whole Genome Sequencing (Genome Report): Doctors and their African American patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient."
11127025|NCT01736566|OG000|Outcome|Family History + Whole Genome Sequencing: Primary Care|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator Arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127026|NCT01736566|OG001|Outcome|Family History + Whole Genome Sequencing - Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator Arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127027|NCT01736566|OG002|Outcome|Extension Cohort|"Standard of Care + Whole Genome Sequencing (Genome Report): Doctors and their African American patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient."
11127028|NCT01736566|OG001|Outcome|Family History Only: Primary Care|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Family History Only: Doctors and their patients receive a Family History report only"
11127029|NCT01736566|OG002|Outcome|Family History + Whole Genome Sequencing - Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127030|NCT01736566|OG003|Outcome|Family History Only: Cardiology|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Family History Only: Doctors and their patients receive a Family History report only"
11127031|NCT01736566|OG004|Outcome|Extension Cohort|"Standard of Care + Whole Genome Sequencing (Genome Report): Doctors and their African American patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient."
11149540|NCT01871441|BG000|Baseline|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
11008030|NCT01094288|EG001|Reported Event|Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008031|NCT01094288|EG002|Reported Event|Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008032|NCT01094288|EG003|Reported Event|Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008033|NCT01094288|EG004|Reported Event|Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008034|NCT01094288|EG005|Reported Event|Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008035|NCT01094288|EG006|Reported Event|Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF|Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008036|NCT01094288|EG007|Reported Event|Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF|Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent.
11008037|NCT01094301|BG000|Baseline|Enrolled Subjects|This group includes subjects that were consented, met eligibility criteria, and received Leads.
11008038|NCT01094301|FG000|Participant Flow|Enrolled Subjects|This group includes subjects that were consented, met eligibility criteria, and received Leads.
11008039|NCT01094301|OG000|Outcome|Trial Stage Subjects|Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
11008040|NCT01094301|OG000|Outcome|Implant Stage Subjects (Subjects Who Received SPR IPG Implant)|Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
11008041|NCT01094301|OG000|Outcome|Enrolled Subjects|This group includes subjects that were consented, met eligibility criteria, and received Leads.
11008042|NCT01094301|EG000|Reported Event|Enrolled Subjects|This group includes subjects that were consented, met eligibility criteria, and received Leads.
11008043|NCT01094522|BG000|Baseline|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11008044|NCT01094522|BG001|Baseline|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11008045|NCT01094522|BG002|Baseline|Total|Total of all reporting groups
11008046|NCT01094522|FG000|Participant Flow|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11008047|NCT01094522|FG001|Participant Flow|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11127032|NCT01736566|OG000|Outcome|Family History + Whole Genome Sequencing: Primary Care|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Active Comparator, in the Extension phase of the study all participants are in the Experimental Arm."
11127033|NCT01736566|OG002|Outcome|Family History + Whole Genome Sequencing: Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Active Comparator arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127034|NCT01736566|OG003|Outcome|Family History Only: Cardiology|"Doctors and their patients receive an Annotated Family History Report only.~Placebo Comparator: Family History Only: Doctors and their patients receive a Family History report only"
11127035|NCT01736566|OG000|Outcome|Family History + Whole Genome Sequencing: Primary Care|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127036|NCT01736566|OG001|Outcome|Family History + Whole Genome Sequencing - Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127037|NCT01736566|OG002|Outcome|Family History + Whole Genome Sequencing - Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which containd genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127038|NCT01736566|EG000|Reported Event|Family History + Whole Genome Sequencing: Primary Care|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator arms, in the Extension phase of the study all participants are in the Experimental Arm."
11127039|NCT01736566|EG001|Reported Event|Family History Only: Primary Care|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Family History Only: Doctors and their patients receive a Family History report only."
11127040|NCT01736566|EG002|Reported Event|Family History + Whole Genome Sequencing: Cardiology|"Doctors and their patients receive a Genome Report and an Annotated Family History Report.~Main Study Experimental: Family History + Whole Genome Sequencing (Genome Report): Doctors and their patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.~Extension Phase: Experimental: Family History + Whole Genome Sequencing (Genome Report)~*In the main study participants are randomized between Experimental and Comparator arms, in the Extension phase of the study all participants are in the Experimental Arm."
10879571|NCT00458484|OG000|Outcome|Series 1: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879572|NCT00458484|OG001|Outcome|Series 2: Stereotactic Radiosurgery|"Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879573|NCT00458484|OG000|Outcome|Series 1/Dose Level 1: Stereotactic Radiosurgery|"Dose Level I: Radiation will be delivered in 4 fractions:~6 Gy x 4 fractions: Total of 24 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
10879574|NCT00458484|OG001|Outcome|Series 1/Dose Level 2: Stereotactic Radiosurgery|"Dose Level 2: Radiation will be delivered in 4 fractions:~8 Gy x 4 fractions: Total of 32 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
10879575|NCT00458484|OG002|Outcome|Series 1/Dose Level 3: Stereotactic Radiosurgery|"Dose Level 3: Radiation will be delivered in 4 fractions:~10 Gy x 4 fractions: Total of 40 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
10879576|NCT00458484|OG003|Outcome|Series 1/Dose Level 4: Stereotactic Radiosurgery|"Dose Level 4: Radiation will be delivered in 4 fractions:~12 Gy x 4 fractions: Total of 48 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
10879577|NCT00458484|OG004|Outcome|Series 2/Dose Level 1: Stereotactic Radiosurgery|"Dose Level I: Radiation will be delivered in 3 fractions:~16 Gy X 3 fractions: Total of 48 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
10879578|NCT00458484|OG005|Outcome|Series 2/Dose Level 2: Stereotactic Radiosurgery|"Dose Level 2: Radiation will be delivered in 3 fractions:~18 Gy x 3 fractions: Total of 54 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
10887357|NCT00500110|EG000|Reported Event|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
11008048|NCT01094522|OG000|Outcome|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11008049|NCT01094522|OG000|Outcome|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11008050|NCT01094522|OG001|Outcome|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11008051|NCT01094522|EG000|Reported Event|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11127041|NCT01736566|EG003|Reported Event|Family History Only: Cardiology|"Doctors and their patients receive an Annotated Family History Report only.~Active Comparator: Family History Only: Doctors and their patients receive a Family History report only"
11127042|NCT01736566|EG004|Reported Event|Extension Cohort|"Family History + Whole Genome Sequencing (Genome Report): Doctors and their African American patients receive a Genome Report and a Family History Report.~There are two sections of the Genome Report:~The General Genome Report, which includes highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.~The Cardiac Risk Supplement, which contains genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient."
11127043|NCT01736579|BG000|Baseline|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
11127044|NCT01736579|BG001|Baseline|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
11127045|NCT01736579|BG002|Baseline|Total|Total of all reporting groups
11127046|NCT01736579|FG000|Participant Flow|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
11127047|NCT01736579|FG001|Participant Flow|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
11127048|NCT01736579|OG000|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
11127049|NCT01736579|OG001|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
11127050|NCT01736579|EG000|Reported Event|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks.
11127051|NCT01736579|EG001|Reported Event|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks.
11127052|NCT01736657|BG000|Baseline|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
11127053|NCT01736657|FG000|Participant Flow|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
11127054|NCT01736657|OG000|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
11127055|NCT01736657|EG000|Reported Event|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
11127056|NCT01736683|BG000|Baseline|Sotatercept 0.1 mg/kg|Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
11127057|NCT01736683|BG001|Baseline|Sotatercept 0.3 mg/kg|Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
11127058|NCT01736683|BG002|Baseline|Sotatercept 0.5 mg/kg|Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
11127059|NCT01736683|BG003|Baseline|Sotatercept 1.0 mg/kg|Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
11127060|NCT01736683|BG004|Baseline|Sotatercept 2.0 mg/kg|Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
11127061|NCT01736683|BG005|Baseline|Total|Total of all reporting groups
11127062|NCT01736683|FG000|Participant Flow|Sotatercept 0.1 mg/kg|Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
11127063|NCT01736683|FG001|Participant Flow|Sotatercept 0.3 mg/kg|Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
11127064|NCT01736683|FG002|Participant Flow|Sotatercept 0.5 mg/kg|Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
11127065|NCT01736683|FG003|Participant Flow|Sotatercept 1.0 mg/kg|Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
11127066|NCT01736683|FG004|Participant Flow|Sotatercept 2.0 mg/kg|Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
11127067|NCT01736683|OG000|Outcome|Sotatercept 0.1 mg/kg|Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
11127068|NCT01736683|OG001|Outcome|Sotatercept 0.3 mg/kg|Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
11127069|NCT01736683|OG002|Outcome|Sotatercept 0.5 mg/kg|Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
11127070|NCT01736683|OG003|Outcome|Sotatercept 1.0 mg/kg|Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
11127071|NCT01736683|OG004|Outcome|Sotatercept 2.0 mg/kg|Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
11127072|NCT01736683|OG002|Outcome|Sotatercept 0.5 mg/kg|Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/ kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
11127073|NCT01736683|OG003|Outcome|Sotatercept 1.0 mg/kg|Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/ kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
11127074|NCT01736683|EG000|Reported Event|Sotatercept 0.1 mg/kg|Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
11127075|NCT01736683|EG001|Reported Event|Sotatercept 0.3 mg/kg|Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
11127076|NCT01736683|EG002|Reported Event|Sotatercept 0.5 mg/kg|Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/ kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
11341982|NCT03694548|OG000|Outcome|Part A Survey Adolescent Patients With SCD and Chronic Pain|"Adolescent Patients with Sickle Cell Disease (SCD) and chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.~Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program."
11341983|NCT03694548|OG000|Outcome|Part A Survey Adolescent Patients With SCD and Chronic Pain|"Part A: Adolescent Patients with Sickle Cell Disease (SCD) and chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.~Participants from Part A Group 1 had the opportunity to enroll in Part B to receive eight in-person instructor-led group yoga sessions. Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions."
11008052|NCT01094522|EG001|Reported Event|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
11008053|NCT01094548|BG000|Baseline|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
11008054|NCT01094548|BG001|Baseline|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
11008055|NCT01094548|BG002|Baseline|Total|Total of all reporting groups
11008056|NCT01094548|FG000|Participant Flow|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
11008057|NCT01094548|FG001|Participant Flow|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
11008058|NCT01094548|OG000|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
11008059|NCT01094548|OG001|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration in Weeks 1 and 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
11008060|NCT01094548|OG001|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg/m^2) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
11067007|NCT01394718|BG000|Baseline|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
11008061|NCT01094548|OG001|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
11008062|NCT01094548|EG000|Reported Event|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
11008063|NCT01094548|EG001|Reported Event|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
11008064|NCT01094574|BG000|Baseline|Alfentanil - Placebo - Propanolol|Participant(s) were randomized to receive an intravenous infusion of alfentanil, normal saline, and propanolol on 3 consecutive study days.
11008065|NCT01094574|BG001|Baseline|Propranolol - Placebo - Alfentanil|Participants were randomized to receive an intravenous infusion of propanolol, normal saline, and alfentanil on 3 consecutive study days.
11008066|NCT01094574|BG002|Baseline|Placebo - Propanolol - Alfentanil|Participants were randomized to receive an intravenous infusion of normal saline, propanolol, and alfentanil on 3 consecutive study days.
11008067|NCT01094574|BG003|Baseline|Alfentanil - Propanolol - Placebo|Participants were randomized to receive an intravenous infusion of alfentanil, propanolol, and normal saline on 3 consecutive study days.
11008068|NCT01094574|BG004|Baseline|Propranolol - Alfentanil - Placebo|Participants were randomized to receive an intravenous infusion of propanolol, alfentanil, and normal saline on 3 consecutive study days.
11008069|NCT01094574|BG005|Baseline|Placebo -Alfentanil - Propanolol|Participants were randomized to receive an intravenous infusion of normal saline, alfentanil, and propanolol on 3 consecutive study days.
11008070|NCT01094574|BG006|Baseline|Total|Total of all reporting groups
11008071|NCT01094574|FG000|Participant Flow|Alfentanil Day 1, Placebo Day 2, and Propranolol Day 3|"Day 1: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
11008072|NCT01094574|FG001|Participant Flow|Propranolol Day 1, Placebo Day 2, and Alfentanil Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 3: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
11008073|NCT01094574|FG002|Participant Flow|Placebo Day 1, Propranolol Day 2, and Alfentanil Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
10887358|NCT00500149|BG000|Baseline|Entire Study Population|
11008074|NCT01094574|FG003|Participant Flow|Alfentanil Day 1, Propranolol Day 2, and Palcebo Day 3|"Day 1: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
11008075|NCT01094574|FG004|Participant Flow|Propranolol Day 1, Alfentanil Day 2, and Placebo Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 2: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
11008076|NCT01094574|FG005|Participant Flow|Placebo Day 1, Alfentanil Day 2, and Propranolol Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 2: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
11008077|NCT01094574|OG000|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
11008078|NCT01094574|OG001|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
11008079|NCT01094574|OG002|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
11008080|NCT01094574|EG000|Reported Event|Alfentanil - Placebo - Propanolol|"An infusion of alfentanil 100ng/ml was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
11008081|NCT01094574|EG001|Reported Event|Propranolol - Placebo - Alfentanil|"An infusion of propranolol 30ng/ml was administered over 3 hours on study day 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
11008082|NCT01094574|EG002|Reported Event|Placebo - Propanolol - Alfentanil|"An infusion of normal saline was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
11008083|NCT01094574|EG003|Reported Event|Alfentanil - Propanolol - Placebo|"An infusion of alfentanil 100ng/ml was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
11127077|NCT01736683|EG003|Reported Event|Sotatercept 1.0 mg/kg|Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/ kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
11127078|NCT01736683|EG004|Reported Event|Sotatercept 2.0 mg/kg|Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
11127079|NCT01736696|BG000|Baseline|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
11127080|NCT01736696|BG001|Baseline|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127081|NCT01736696|BG002|Baseline|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127082|NCT01736696|BG003|Baseline|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127083|NCT01736696|BG004|Baseline|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
11127084|NCT01736696|BG005|Baseline|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
11127085|NCT01736696|BG006|Baseline|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
11127086|NCT01736696|BG007|Baseline|Total|Total of all reporting groups
11127087|NCT01736696|FG000|Participant Flow|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
11127088|NCT01736696|FG001|Participant Flow|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127089|NCT01736696|FG002|Participant Flow|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127090|NCT01736696|FG003|Participant Flow|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127091|NCT01736696|FG004|Participant Flow|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
11127092|NCT01736696|FG005|Participant Flow|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
11127093|NCT01736696|FG006|Participant Flow|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
11127094|NCT01736696|OG000|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
11127095|NCT01736696|OG001|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127096|NCT01736696|OG002|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127097|NCT01736696|OG003|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127098|NCT01736696|OG004|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
11127099|NCT01736696|OG005|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
11127100|NCT01736696|OG006|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
11127101|NCT01736696|OG000|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
11127102|NCT01736696|OG001|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
11127103|NCT01736696|OG000|Outcome|All CP-690,550 Treated Participants|Included all participants who received either CP-690,550 OPC or CP-690,550 tablets for 14 days.
11127104|NCT01736696|OG001|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127105|NCT01736696|OG002|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
11127106|NCT01736696|OG001|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127107|NCT01736696|OG002|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127108|NCT01736696|OG003|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
11127109|NCT01736696|EG000|Reported Event|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
11127110|NCT01736696|EG001|Reported Event|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127111|NCT01736696|EG002|Reported Event|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127112|NCT01736696|EG003|Reported Event|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
11127113|NCT01736696|EG004|Reported Event|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
11127114|NCT01736696|EG005|Reported Event|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
11127115|NCT01736696|EG006|Reported Event|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
11127116|NCT01736852|BG000|Baseline|CRB Plus Pitocin|"CRB: Labor induction using the CRB~Pitocin: Labor induction using Pitocin"
11127117|NCT01736852|BG001|Baseline|Pitocin|Pitocin: Labor induction using Pitocin
11127118|NCT01736852|BG002|Baseline|Total|Total of all reporting groups
11127119|NCT01736852|FG000|Participant Flow|CRB Plus Pitocin|"CRB: Labor induction using the CRB~Pitocin: Labor induction using Pitocin"
11127120|NCT01736852|FG001|Participant Flow|Pitocin|Pitocin: Labor induction using Pitocin
11127121|NCT01736852|OG000|Outcome|CRB Plus Pitocin|"CRB: Labor induction using the CRB~Pitocin: Labor induction using Pitocin"
11127122|NCT01736852|OG001|Outcome|Pitocin|Pitocin: Labor induction using Pitocin
11127123|NCT01736852|EG000|Reported Event|CRB Plus Pitocin|"CRB: Labor induction using the CRB~Pitocin: Labor induction using Pitocin"
11127124|NCT01736852|EG001|Reported Event|Pitocin|Pitocin: Labor induction using Pitocin
11127125|NCT01736865|BG000|Baseline|Placebo|"One placebo pill daily for 1 year~Placebo"
11127126|NCT01736865|BG001|Baseline|Cholecalciferol|"One cholecalciferol pill daily for 1 year~Cholecalciferol"
11127127|NCT01736865|BG002|Baseline|Total|Total of all reporting groups
11127128|NCT01736865|FG000|Participant Flow|Placebo|"One placebo pill daily for 1 year~Placebo"
11127129|NCT01736865|FG001|Participant Flow|Cholecalciferol|"One cholecalciferol pill daily for 1 year~Cholecalciferol"
11127130|NCT01736865|OG000|Outcome|Placebo|"One placebo pill daily for 1 year~Placebo"
11127131|NCT01736865|OG001|Outcome|Cholecalciferol|"One cholecalciferol pill daily for 1 year~Cholecalciferol"
11127132|NCT01736865|EG000|Reported Event|Placebo|"One placebo pill daily for 1 year~Placebo"
11127133|NCT01736865|EG001|Reported Event|Cholecalciferol|"One cholecalciferol pill daily for 1 year~Cholecalciferol"
11127134|NCT01736917|BG000|Baseline|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
11127135|NCT01736917|FG000|Participant Flow|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
11127136|NCT01736917|OG000|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
11127137|NCT01736917|OG000|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
11127138|NCT01736917|OG000|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
11127139|NCT01736917|EG000|Reported Event|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
11127140|NCT01736930|BG000|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11127141|NCT01736930|FG000|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11127142|NCT01736930|OG000|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
11127143|NCT01736930|OG001|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11127144|NCT01736930|EG000|Reported Event|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
11127145|NCT01736930|EG001|Reported Event|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11127146|NCT01736943|BG000|Baseline|Bortezomib + Doxil|"Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).~Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.~Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle."
11127147|NCT01736943|FG000|Participant Flow|Bortezomib + Doxil|"Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).~Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.~Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle."
11127148|NCT01736943|OG000|Outcome|Bortezomib + Doxil|"Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).~Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.~Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle."
11127149|NCT01736943|EG000|Reported Event|Bortezomib + Doxil|"Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).~Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.~Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle."
11127150|NCT01737268|BG000|Baseline|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
11127151|NCT01737268|FG000|Participant Flow|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
11127152|NCT01737268|OG000|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
11127153|NCT01737268|OG000|Outcome|FK949E Elderly Participant|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period
11008084|NCT01094574|EG004|Reported Event|Propranolol - Alfentanil - Placebo|"An infusion of propranolol 30ng/ml was administered over 3 hours on study day 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
11008085|NCT01094574|EG005|Reported Event|Placebo -Alfentanil - Propanolol|"An infusion of normal saline was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
11008086|NCT01094704|BG000|Baseline|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
11008087|NCT01094704|BG001|Baseline|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
11008088|NCT01094704|BG002|Baseline|Total|Total of all reporting groups
11008089|NCT01094704|FG000|Participant Flow|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
11008090|NCT01094704|FG001|Participant Flow|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
11008091|NCT01094704|OG000|Outcome|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
11008092|NCT01094704|OG001|Outcome|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
11008093|NCT01094704|EG000|Reported Event|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
11008094|NCT01094704|EG001|Reported Event|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
11008095|NCT01094717|BG000|Baseline|Acitretin and Excimer|excimer vs sham excimer: half of lesions will be treated with excimer laser; half of lesions will be treated with sham excimer (opaque cover on the laser device)
11008096|NCT01094717|BG001|Baseline|Tazarotene and Excimer|excimer vs sham excimer: half of lesions will be treated with excimer laser; half of lesions will be treated with sham excimer (opaque cover on the laser device)
11008097|NCT01094717|BG002|Baseline|Total|Total of all reporting groups
11008098|NCT01094717|FG000|Participant Flow|Acitretin and Excimer|Patients treated with acitretin 25 mg daily and active excimer laser to lesions on one half of the body (side assigned to active laser) and sham excimer laser (opaque cover on laser lens)to lesions on the other half of the body (side assigned to sham laser).
11008099|NCT01094717|FG001|Participant Flow|Tazarotene Gel and Excimer Laser|patients in this group applied tazarotene 0.1% gel to all lesions and active excimer laser used to treat lesions on one half of the body (side assigned to active laser) and sham excimer laser (opaque cover applied over laser lens) used to treat lesions on the other half of the body (side assigned to sham laser).
11008100|NCT01094717|OG000|Outcome|Acitretin and Excimer|patients received acitretin 25 mg daily and active excimer laser excimer twice weekly to lesions on one of half of the body that was assigned to active laser (left or right determined by randomization)
11008101|NCT01094717|OG001|Outcome|Acitretin and Sham (Placebo) Excimer|patients received acitretin 25 mg daily and sham (placebo) excimer twice weekly to lesions on one of half of the body that was assigned to sham (left or right determined by randomization)
11008102|NCT01094717|OG002|Outcome|Tazarotene Gel and Excimer Laser|patients received topical tazarotene gel 0.1% applied to all lesions daily, and active excimer laser excimer twice weekly to lesions on one of half of the body that was assigned to active laser (left or right determined by randomization)
11008103|NCT01094717|OG003|Outcome|Tazarotene Gel and Sham (Placebo) Excimer|patients receive tazarotene gel 0.1% applied daily to all lesions, and sham excimer twice weekly to lesions on one of half of the body that was assigned to sham (left or right determined by randomization)
11008104|NCT01094717|OG000|Outcome|Acitretin and Excimer|"patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to one side of the body and sham excimer (placebo) to the to the other side of body.~excimer vs sham excimer: half of lesions will be treated with excimer laser; half of lesions will be treated with sham excimer (opaque cover on the laser device)"
11008105|NCT01094717|OG001|Outcome|Acitretin and Sham Excimer Laser|patients treated with acitretin 25 mg and sham excimer laser.
11008106|NCT01094717|OG002|Outcome|Tazarotene and Excimer|"patients enrolled in the tazarotene arm will be treated with topical tazarotene 0.1% gel and excimer (active) to one side of the body and sham excimer (placebo) to the to the other side of body.~excimer vs sham excimer: half of lesions will be treated with excimer laser; half of lesions will be treated with sham excimer (opaque cover on the laser device)"
11008107|NCT01094717|OG003|Outcome|Tazarotene and Sham Excimer Laser|patients receiving tazotene gel 0.1% and sham excimer laser to half of body.
11008108|NCT01094717|OG000|Outcome|Acitretin and Active Excimer Laser|"patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions.~excimer laser (active): Lesions on randomly assigned left or right side of body were treated with active excimer laser by an increasing dose level per a standard of care protocol.~Acitretin 25 MG: Patients assigned to this intervention took oral acitretin 25 mg daily."
11008109|NCT01094717|OG001|Outcome|Acitretin and Sham Excimer Laser|"Patients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of body psoriasis lesions.~excimer laser (sham): Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).~Acitretin 25 MG: Patients assigned to this intervention took oral acitretin 25 mg daily."
11127154|NCT01737268|EG000|Reported Event|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
11127155|NCT01737281|BG000|Baseline|Proactive Outreach|Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer.
11127156|NCT01737281|BG001|Baseline|Usual Care|Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion.
11127157|NCT01737281|BG002|Baseline|Total|Total of all reporting groups
11127158|NCT01737281|FG000|Participant Flow|Proactive Outreach|"Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy.~Proactive outreach: Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling."
11127159|NCT01737281|FG001|Participant Flow|Usual Care|"Usual smoking cessation care from clinical staff~Usual care: Usual smoking cessation care from VA clinical staff."
11127160|NCT01737281|OG000|Outcome|Proactive Outreach|Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer.
11127161|NCT01737281|OG001|Outcome|Usual Care|Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion.
11127162|NCT01737281|EG000|Reported Event|Intervention Arm|Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer.
11127163|NCT01737281|EG001|Reported Event|Control Arm|Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion.
11149541|NCT01871441|FG000|Participant Flow|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
11149542|NCT01871441|OG000|Outcome|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28."
11149543|NCT01871441|OG000|Outcome|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
11149544|NCT01871441|EG000|Reported Event|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
11149545|NCT01871506|BG000|Baseline|Standard Treatment (ST)|"Participants randomized to standard treatment will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.~(2) 3 Weekly Follow-up Counseling Sessions: ST Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.~(3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects."
11127164|NCT01737398|BG000|Baseline|Inotersen|Participants received 3 SC doses of 300 mg inotersen during Week 1, followed by once-weekly SC administration for 64 weeks.
11127165|NCT01737398|BG001|Baseline|Placebo|Participants received 3 SC doses of placebo during Week 1, followed by once-weekly SC administration for 64 weeks.
11127166|NCT01737398|BG002|Baseline|Total|Total of all reporting groups
11127167|NCT01737398|FG000|Participant Flow|Inotersen|Participants received 3 subcutaneous (SC) doses of 300 milligrams (mg) inotersen during Week 1, followed by once-weekly SC administration for 64 weeks.
11127168|NCT01737398|FG001|Participant Flow|Placebo|Participants received 3 SC doses of placebo during Week 1, followed by once-weekly SC administration for 64 weeks.
11127169|NCT01737398|OG000|Outcome|Inotersen|Participants received 3 SC doses of 300 mg inotersen during Week 1, followed by once-weekly SC administration for 64 weeks.
11127170|NCT01737398|OG001|Outcome|Placebo|Participants received 3 SC doses of placebo during Week 1, followed by once-weekly SC administration for 64 weeks.
11127171|NCT01737398|OG000|Outcome|Inotersen 300 mg IM Negative|Participants received 3 SC doses of 300 mg inotersen during Week 1, followed by once-weekly SC administration for 64 weeks, and had a negative immunogenicity (IM) status.
11127172|NCT01737398|OG001|Outcome|Inotersen 300 mg IM Positive|Participants received 3 SC doses of 300 mg inotersen during Week 1, followed by once-weekly SC administration for 64 weeks, and had a positive IM status.
11127173|NCT01737398|OG000|Outcome|Inotersen 300 mg IM Negative|Participants received 3 SC doses of 300 mg inotersen during Week 1, followed by once-weekly SC administration for 64 weeks, and had a negative IM status.
11127174|NCT01737398|EG000|Reported Event|Inotersen|Participants received 3 SC doses of 300 mg inotersen during Week 1, followed by once-weekly SC administration for 64 weeks.
11127175|NCT01737398|EG001|Reported Event|Placebo|Participants received 3 SC doses of placebo during Week 1, followed by once-weekly SC administration for 64 weeks.
11127176|NCT01737593|BG000|Baseline|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
11127177|NCT01737593|BG001|Baseline|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127178|NCT01737593|BG002|Baseline|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127179|NCT01737593|BG003|Baseline|Total|Total of all reporting groups
11127180|NCT01737593|FG000|Participant Flow|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
11127181|NCT01737593|FG001|Participant Flow|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127182|NCT01737593|FG002|Participant Flow|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127183|NCT01737593|OG000|Outcome|Acetaminophen by Rectum (PR)|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
11127184|NCT01737593|OG001|Outcome|Acetaminophen by Mouth (PO) - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127185|NCT01737593|OG002|Outcome|Acetaminophen by Mouth (PO) - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127186|NCT01737593|OG000|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
11127187|NCT01737593|OG001|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127188|NCT01737593|OG002|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127189|NCT01737593|EG000|Reported Event|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
11127190|NCT01737593|EG001|Reported Event|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127191|NCT01737593|EG002|Reported Event|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
11127192|NCT01737684|BG000|Baseline|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11127193|NCT01737684|BG001|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
11127194|NCT01737684|BG002|Baseline|Total|Total of all reporting groups
11127195|NCT01737684|FG000|Participant Flow|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11127196|NCT01737684|FG001|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
11127197|NCT01737684|FG002|Participant Flow|Participants With Mild Hepatic Insufficiencey|Participants with mild hepatic insufficiency were to receive a single oral dose of vibegron 100 mg.
11127198|NCT01737684|OG000|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11127199|NCT01737684|OG001|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
11127200|NCT01737684|EG000|Reported Event|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
11127201|NCT01737684|EG001|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
11127202|NCT01737697|BG000|Baseline|Acute Phase: Placebo TID|Participants administered placebo three times daily (TID) orally as suspension for first 48 hours.
11127203|NCT01737697|BG001|Baseline|Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID|Participants administered ZS 1.25 g TID as suspension orally for first 48 hours.
11127204|NCT01737697|BG002|Baseline|Acute Phase: ZS 2.5 g TID|Participants administered ZS 2.5 g TID as suspension orally for first 48 hours.
11127205|NCT01737697|BG003|Baseline|Acute Phase: ZS 5 g TID|Participants administered ZS 5 g TID as suspension orally for first 48 hours.
11127206|NCT01737697|BG004|Baseline|Acute Phase: ZS 10 TID|Participants administered ZS 10 g TID as suspension orally for first 48 hours.
11127207|NCT01737697|BG005|Baseline|Total|Total of all reporting groups
11127208|NCT01737697|FG000|Participant Flow|Acute Phase: Placebo|Participants administered placebo as suspension orally three times a day (TID) for first 48 hours.
11127209|NCT01737697|FG001|Participant Flow|Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID|Participants administered ZS 1.25 g TID as suspension orally for first 48 hours.
11127210|NCT01737697|FG002|Participant Flow|Acute Phase: ZS 2.5 g TID|Participants administered ZS 2.5 g TID as suspension orally for first 48 hours.
11127211|NCT01737697|FG003|Participant Flow|Acute Phase: ZS 5 g TID|Participants administered ZS 5 g TID as suspension orally for first 48 hours.
11127212|NCT01737697|FG004|Participant Flow|Acute Phase: ZS 10 TID|Participants administered ZS 10 g TID as suspension orally for first 48 hours.
11127213|NCT01737697|FG005|Participant Flow|Subacute Phase: Placebo Matched to ZS 1.25g QD|Participants who received ZS 1.25 g TID in the acute phase and administered placebo as suspension once daily (QD) for 12 days.
11127214|NCT01737697|FG006|Participant Flow|Subacute Phase: ZS 1.25 g QD|Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days.
11127215|NCT01737697|FG007|Participant Flow|Subacute Phase: Placebo Matched to ZS 2.5 g QD|Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127216|NCT01737697|FG008|Participant Flow|Subacute Phase: ZS 2.5 g QD|Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
11127217|NCT01737697|FG009|Participant Flow|Subacute Phase: Placebo Matched to ZS 5 g QD|Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127218|NCT01737697|FG010|Participant Flow|Subacute Phase: ZS 5 g QD|Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days.
11127219|NCT01737697|FG011|Participant Flow|Subacute Phase: Placebo Matched to ZS 10 g QD|Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127220|NCT01737697|FG012|Participant Flow|Subacute Phase: ZS 10 g QD|Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days.
11127221|NCT01737697|FG013|Participant Flow|Subacute Phase: ZS 1.25 (Acute Phase: Placebo)|Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days.
11127222|NCT01737697|FG014|Participant Flow|Subacute Phase: ZS 2.5 g (Acute Phase: Placebo)|Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
11127223|NCT01737697|OG000|Outcome|Acute Phase: Placebo TID|Participants administered placebo three times daily (TID) orally as suspension for first 48 hours.
11127224|NCT01737697|OG001|Outcome|Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID|Participants administered ZS 1.25 g TID as suspension orally for first 48 hours.
11127225|NCT01737697|OG002|Outcome|Acute Phase: ZS 2.5 g TID|Participants administered ZS 2.5 g TID as suspension orally for first 48 hours.
11127226|NCT01737697|OG003|Outcome|Acute Phase: ZS 5 g TID|Participants administered ZS 5 g TID as suspension orally for first 48 hours.
11127227|NCT01737697|OG004|Outcome|Acute Phase: ZS 10 g TID|Participants administered ZS 10 g TID as suspension orally for first 48 hours.
11127228|NCT01737697|OG000|Outcome|Subacute Phase: Placebo Matched to ZS 1.25 g QD|Participants who received ZS 1.25 g TID in the acute phase and received placebo matched to ZS 1.25 g QD for 12 days.
11127229|NCT01737697|OG001|Outcome|Subacute Phase: ZS 1.25 g QD|Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days.
11127230|NCT01737697|OG002|Outcome|Subacute Phase: Placebo Matched to ZS 2.5 g QD|Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127231|NCT01737697|OG003|Outcome|Subacute Phase: ZS 2.5 g QD|Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
11127232|NCT01737697|OG004|Outcome|Subacute Phase: Placebo Matched to ZS 5 g QD|Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127233|NCT01737697|OG005|Outcome|Subacute Phase: ZS 5 g QD|Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days.
11127234|NCT01737697|OG006|Outcome|Subacute Phase: Placebo Matched to ZS 10 g QD|Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127235|NCT01737697|OG007|Outcome|Subacute Phase: ZS 10 g QD|Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days.
11127236|NCT01737697|OG008|Outcome|Subacute Phase: ZS 1.25 (Acute Phase: Placebo)|Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days.
11127237|NCT01737697|OG009|Outcome|Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo)|Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
11127238|NCT01737697|OG009|Outcome|Subacute Phase: ZS 2.5 g (Acute Phase: Placebo)|Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
11127239|NCT01737697|EG000|Reported Event|Acute Phase: Placebo TID|Participants administered placebo three times daily (TID) orally as suspension for first 48 hours.
11127240|NCT01737697|EG001|Reported Event|Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID|Participants administered ZS 1.25 g TID as suspension orally for first 48 hours.
11127241|NCT01737697|EG002|Reported Event|Acute Phase: ZS 2.5 g TID|Participants administered ZS 2.5 g TID as suspension orally for first 48 hours.
11127242|NCT01737697|EG003|Reported Event|Acute Phase: ZS 5 g TID|Participants administered ZS 5 g TID as suspension orally for first 48 hours.
11127243|NCT01737697|EG004|Reported Event|Acute Phase: ZS 10 TID|Participants administered ZS 10 g TID as suspension orally for first 48 hours.
11127244|NCT01737697|EG005|Reported Event|Subacute Phase: Placebo Matched to ZS 1.25g QD|Participants who received ZS 1.25 g TID in the acute phase and administered placebo as suspension once daily (QD) for 12 days.
11127245|NCT01737697|EG006|Reported Event|Subacute Phase: ZS 1.25 g QD|Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days.
11127246|NCT01737697|EG007|Reported Event|Subacute Phase: Placebo Matched to ZS 2.5 g QD|Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127247|NCT01737697|EG008|Reported Event|Subacute Phase: ZS 2.5 g QD|Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
11127248|NCT01737697|EG009|Reported Event|Subacute Phase: Placebo Matched to ZS 5 g QD|Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127249|NCT01737697|EG010|Reported Event|Subacute Phase: ZS 5 g QD|Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days.
11127250|NCT01737697|EG011|Reported Event|Subacute Phase: Placebo Matched to ZS 10 g QD|Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days.
11127251|NCT01737697|EG012|Reported Event|Subacute Phase: ZS 10 g QD|Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days.
11127252|NCT01737697|EG013|Reported Event|Subacute Phase: ZS 1.25 g QD (Acute Phase: Placebo)|Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days.
11127253|NCT01737697|EG014|Reported Event|Subacute Phase: ZS 2.5 g QD (Acute Phase; Placebo)|Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
11127254|NCT01737710|BG000|Baseline|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127255|NCT01737710|BG001|Baseline|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127256|NCT01737710|BG002|Baseline|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
11127257|NCT01737710|BG003|Baseline|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
11127258|NCT01737710|BG004|Baseline|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127259|NCT01737710|BG005|Baseline|Total|Total of all reporting groups
11127260|NCT01737710|FG000|Participant Flow|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127261|NCT01737710|FG001|Participant Flow|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127262|NCT01737710|FG002|Participant Flow|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
11127263|NCT01737710|FG003|Participant Flow|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
11127264|NCT01737710|FG004|Participant Flow|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127265|NCT01737710|OG000|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127266|NCT01737710|OG001|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127267|NCT01737710|OG000|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127268|NCT01737710|OG001|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
11127269|NCT01737710|EG000|Reported Event|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127270|NCT01737710|EG001|Reported Event|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127271|NCT01737710|EG002|Reported Event|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
11127272|NCT01737710|EG003|Reported Event|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
11127273|NCT01737710|EG004|Reported Event|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
11127274|NCT01737762|BG000|Baseline|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
11127275|NCT01737762|BG001|Baseline|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
11127276|NCT01737762|BG002|Baseline|Total|Total of all reporting groups
11127277|NCT01737762|FG000|Participant Flow|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
11127278|NCT01737762|FG001|Participant Flow|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
11127279|NCT01737762|OG000|Outcome|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
11127280|NCT01737762|OG001|Outcome|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
11127281|NCT01737762|EG000|Reported Event|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
11127282|NCT01737762|EG001|Reported Event|Vehicle|"Vehicle Control(fibrinogen solution & thrombin solution without cells)~Vehicle"
11127283|NCT01737840|BG000|Baseline|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
11127284|NCT01737840|BG001|Baseline|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
11127285|NCT01737840|BG002|Baseline|Total|Total of all reporting groups
11127286|NCT01737840|FG000|Participant Flow|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
11127287|NCT01737840|FG001|Participant Flow|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
11127288|NCT01737840|OG000|Outcome|Pantoprazole|Intravenous pantoprazole 40 mg
11127289|NCT01737840|OG001|Outcome|Ranitidine|Intravenous ranitidine 50 mg
11127290|NCT01737840|OG000|Outcome|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
11127291|NCT01737840|OG001|Outcome|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
11127292|NCT01737840|EG000|Reported Event|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
11127293|NCT01737840|EG001|Reported Event|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
11127294|NCT01737879|BG000|Baseline|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
11127295|NCT01737879|FG000|Participant Flow|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
11127296|NCT01737879|OG000|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
11127297|NCT01737879|EG000|Reported Event|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
11127298|NCT01737931|BG000|Baseline|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
11127299|NCT01737931|BG001|Baseline|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
11127300|NCT01737931|BG002|Baseline|No-treatment|No treatment to the application sites after the patch removal
11127301|NCT01737931|BG003|Baseline|Total|Total of all reporting groups
11127302|NCT01737931|FG000|Participant Flow|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
11127303|NCT01737931|FG001|Participant Flow|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
11127304|NCT01737931|FG002|Participant Flow|No-treatment|No treatment to the application sites after the patch removal
11127305|NCT01737931|OG000|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
11127306|NCT01737931|OG001|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
11127307|NCT01737931|OG002|Outcome|No-treatment|No treatment to the application sites after the patch removal
11127308|NCT01737931|EG000|Reported Event|Over-all|"In this study, all the subjects were received SPM962 with the same dose and regimen during the acceleration and dose-escalation periods and then they were randomized into one of the three groups after removal of SPM962 to evaluate recovery of skin reaction caused by SPM962 using either steroids, antihistamine or no treatment.~Since AEs mainly occurred in the acceleration and dose-escalation periods when SPM962 were used, AEs are shown in one group."
11127309|NCT01737944|BG000|Baseline|10mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
11127310|NCT01737944|BG001|Baseline|15mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
11127311|NCT01737944|BG002|Baseline|20mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
11127312|NCT01737944|BG003|Baseline|25mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
11127313|NCT01737944|BG004|Baseline|Total|Total of all reporting groups
11127314|NCT01737944|FG000|Participant Flow|10mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
11127315|NCT01737944|FG001|Participant Flow|15mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
11127316|NCT01737944|FG002|Participant Flow|20mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
11127317|NCT01737944|FG003|Participant Flow|25mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
11127318|NCT01737944|OG000|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
11127319|NCT01737944|OG001|Outcome|Treatment Arm B|SC injection of MTX without the device
11127320|NCT01737944|OG002|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
11127321|NCT01737944|EG000|Reported Event|10mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
11127322|NCT01737944|EG001|Reported Event|15mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
11127323|NCT01737944|EG002|Reported Event|20mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
11127324|NCT01737944|EG003|Reported Event|25mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
11127325|NCT01737996|BG000|Baseline|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
11127326|NCT01737996|BG001|Baseline|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
11127327|NCT01737996|BG002|Baseline|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
11127328|NCT01737996|BG003|Baseline|Total|Total of all reporting groups
11127329|NCT01737996|FG000|Participant Flow|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
11127330|NCT01737996|FG001|Participant Flow|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
11127331|NCT01737996|FG002|Participant Flow|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
11127332|NCT01737996|OG000|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
11127333|NCT01737996|OG001|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
11127334|NCT01737996|OG000|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
11127335|NCT01737996|EG000|Reported Event|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
11127336|NCT01737996|EG001|Reported Event|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
11127337|NCT01737996|EG002|Reported Event|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
11127338|NCT01738191|BG000|Baseline|Atomoxetine|"The study drug target dose is Atomoxetine (ATM) 80 milligram (mg) per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.~Atomoxetine: The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily."
11127339|NCT01738191|BG001|Baseline|Placebo|"Patients in the placebo arm will follow the same titration schedule as those in the active arm. Patients will titrate up to target dose by starting 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose to 80mg daily.~Placebo"
11127340|NCT01738191|BG002|Baseline|Total|Total of all reporting groups
11127341|NCT01738191|FG000|Participant Flow|Atomoxetine|"The study drug target dose is Atomoxetine (ATM) 80 milligram (mg) per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.~Atomoxetine: The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily."
11127342|NCT01738191|FG001|Participant Flow|Placebo|"Patients in the placebo arm will follow the same titration schedule as those in the active arm. Patients will titrate up to target dose by starting 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose to 80mg daily.~Placebo"
11127343|NCT01738191|OG000|Outcome|Atomoxetine|"The study drug target dose is Atomoxetine (ATM) 80 milligram (mg) per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.~Atomoxetine: The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily."
11127344|NCT01738191|OG001|Outcome|Placebo|"Patients in the placebo arm will follow the same titration schedule as those in the active arm. Patients will titrate up to target dose by starting 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose to 80mg daily.~Placebo"
11127345|NCT01738191|EG000|Reported Event|Atomoxetine|"The study drug target dose is Atomoxetine (ATM) 80 milligram (mg) per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.~Atomoxetine: The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily."
11127346|NCT01738191|EG001|Reported Event|Placebo|"Patients in the placebo arm will follow the same titration schedule as those in the active arm. Patients will titrate up to target dose by starting 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose to 80mg daily.~Placebo"
11127347|NCT01738321|BG000|Baseline|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
11127348|NCT01738321|BG001|Baseline|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
11127349|NCT01738321|BG002|Baseline|Total|Total of all reporting groups
11127350|NCT01738321|FG000|Participant Flow|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
11127351|NCT01738321|FG001|Participant Flow|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
11127352|NCT01738321|OG000|Outcome|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
11127353|NCT01738321|OG001|Outcome|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
11127354|NCT01738321|EG000|Reported Event|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
11127355|NCT01738321|EG001|Reported Event|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
11127356|NCT01738438|BG000|Baseline|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
11127357|NCT01738438|FG000|Participant Flow|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
11127358|NCT01738438|OG000|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
11127359|NCT01738438|EG000|Reported Event|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
11127360|NCT01738477|BG000|Baseline|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
11127361|NCT01738477|BG001|Baseline|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
11127362|NCT01738477|BG002|Baseline|Total|Total of all reporting groups
11127363|NCT01738477|FG000|Participant Flow|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
11127364|NCT01738477|FG001|Participant Flow|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
11127365|NCT01738477|OG000|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
11127366|NCT01738477|OG001|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
11127367|NCT01738477|OG000|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
11127368|NCT01738477|OG001|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
11127369|NCT01738477|EG000|Reported Event|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
11127370|NCT01738477|EG001|Reported Event|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
11127371|NCT01738503|BG000|Baseline|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
11127372|NCT01738503|BG001|Baseline|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
11127373|NCT01738503|BG002|Baseline|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127374|NCT01738503|BG003|Baseline|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
11127375|NCT01738503|BG004|Baseline|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127376|NCT01738503|BG005|Baseline|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127377|NCT01738503|BG006|Baseline|Total|Total of all reporting groups
11127378|NCT01738503|FG000|Participant Flow|SUBUTEX|Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL. Those who did not complete this period, did not continue into the Treatment period.
11127379|NCT01738503|FG001|Participant Flow|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
11127380|NCT01738503|FG002|Participant Flow|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
11127381|NCT01738503|FG003|Participant Flow|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127382|NCT01738503|FG004|Participant Flow|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
11127383|NCT01738503|FG005|Participant Flow|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127384|NCT01738503|FG006|Participant Flow|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127385|NCT01738503|OG000|Outcome|SUBUTEX Only|Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL and did not continue into the Treatment period.
11127386|NCT01738503|OG001|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
11127387|NCT01738503|OG002|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
11127388|NCT01738503|OG003|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127389|NCT01738503|OG004|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
11127390|NCT01738503|OG005|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127391|NCT01738503|OG006|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127392|NCT01738503|OG000|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
11127393|NCT01738503|OG001|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
11127394|NCT01738503|OG002|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127395|NCT01738503|OG003|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
11127396|NCT01738503|OG004|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127397|NCT01738503|OG005|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127398|NCT01738503|EG000|Reported Event|SUBUTEX Only|Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL and did not continue into the Treatment period.
11127399|NCT01738503|EG001|Reported Event|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
11127400|NCT01738503|EG002|Reported Event|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
11127401|NCT01738503|EG003|Reported Event|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127402|NCT01738503|EG004|Reported Event|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
11127403|NCT01738503|EG005|Reported Event|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 112 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127404|NCT01738503|EG006|Reported Event|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
11127405|NCT01738581|BG000|Baseline|rTMS + Sensorimotor Retraining, rTMS + CTL|"Repetitive transcranial magnetic (rTMS) stimulation and sensorimotor retraining for the first phase, then rTMS with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
11127406|NCT01738581|BG001|Baseline|rTMS + CTL, rTMS + Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation (rTMS) with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion for the first phase, then rTMS with sensorimotor retraining.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
11127407|NCT01738581|BG002|Baseline|Total|Total of all reporting groups
11127408|NCT01738581|FG000|Participant Flow|rTMS + SMR, Then rTMS + CTL|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
11127409|NCT01738581|FG001|Participant Flow|rTMS + CTL, Then rTMS + SMR|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
11127410|NCT01738581|OG000|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
11127411|NCT01738581|OG001|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
11127412|NCT01738581|EG000|Reported Event|rTMS With Sensorimotor Retraining, Then rTMS With CTL|"Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining for first phase, then rTMS with control (CTL) therapy.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
11127413|NCT01738581|EG001|Reported Event|rTMS With CTL, Then rTMS With Sensorimotor Retrain|"Repetitive transcranial magnetic stimulation (rTMS) with control (CTL) non-specific therapy that includes stretching, massage, range of motion for first phase, then rTMS with sensorimotor retraining for second phase.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
11127414|NCT01738594|BG000|Baseline|Arm A, Cohort 1 (Carfilzomib)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.~carfilzomib: Given IV laboratory biomarker analysis: Correlative studies"
11127415|NCT01738594|BG001|Baseline|Arm B Cohort 1 (Carfilzomib + Romidepsin)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle. carfilzomib: Given IV romidepsin: Given IV laboratory biomarker analysis: Correlative studies"
11127416|NCT01738594|BG002|Baseline|Arm B Cohort 2 (Carfilzomib + Romidepsin)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 45 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle. carfilzomib: Given IV romidepsin: Given IV laboratory biomarker analysis: Correlative studies"
11127417|NCT01738594|BG003|Baseline|Total|Total of all reporting groups
11127418|NCT01738594|FG000|Participant Flow|Arm A, Cohort -1 (Carfilzomib)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.~carfilzomib: Given IV~laboratory biomarker analysis: Correlative studies"
11127419|NCT01738594|FG001|Participant Flow|Arm A, Cohort 1 (Carfilzomib)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.~carfilzomib: Given IV~laboratory biomarker analysis: Correlative studies"
11127420|NCT01738594|FG002|Participant Flow|Arm A, Cohort 2 (Carfilzomib)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 45 mg/m2.~carfilzomib: Given IV~laboratory biomarker analysis: Correlative studies"
11127421|NCT01738594|FG003|Participant Flow|Arm A, Cohort 3 (Carfilzomib)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 56 mg/m2.~carfilzomib: Given IV~laboratory biomarker analysis: Correlative studies"
11127422|NCT01738594|FG004|Participant Flow|Arm B Cohort -1 (Carfilzomib + Romidepsin)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127423|NCT01738594|FG005|Participant Flow|Arm B Cohort 1 (Carfilzomib + Romidepsin|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127424|NCT01738594|FG006|Participant Flow|Arm B Cohort 2 (Carfilzomib + Romidepsin)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 45 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127425|NCT01738594|FG007|Participant Flow|Arm B Cohort 3 (Carfilzomib + Romidepsin)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 56 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127426|NCT01738594|OG000|Outcome|Arm A, Cohort 1 (Carfilzomib)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.~carfilzomib: Given IV~laboratory biomarker analysis: Correlative studies"
11127427|NCT01738594|OG001|Outcome|Arm B Cohort -1 (Carfilzomib + Romidepsin)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127428|NCT01738594|OG002|Outcome|Arm B Cohort 1 (Carfilzomib + Romidepsin|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127429|NCT01738594|OG000|Outcome|Arm A (Carfilzomib)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16.~carfilzomib: Given IV~laboratory biomarker analysis: Correlative studies"
11127430|NCT01738594|OG001|Outcome|Arm B (Carfilzomib, Romidepsin)|"Patients receive carfilzomib as in Arm A and romidepsin IV over 4 hours on days 1, 8, and 15.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127431|NCT01738594|EG000|Reported Event|Arm A, Cohort 1 (Carfilzomib)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.~carfilzomib: Given IV~laboratory biomarker analysis: Correlative studies"
11127432|NCT01738594|EG001|Reported Event|Arm B Cohort -1 (Carfilzomib + Romidepsin)|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127433|NCT01738594|EG002|Reported Event|Arm B Cohort 1 (Carfilzomib + Romidepsin|"Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.~Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.~and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.~carfilzomib: Given IV~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11127434|NCT01738646|BG000|Baseline|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
11127435|NCT01738646|FG000|Participant Flow|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
11127436|NCT01738646|OG000|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
11127437|NCT01738646|OG000|Outcome|Vorinostat & Bevacizumab|"Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.~Vorinostat~Bevacizumab"
11127438|NCT01738646|EG000|Reported Event|Vorinostat & Bevacizumab|Patients will be evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
11127439|NCT01738672|BG000|Baseline|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
11127440|NCT01738672|FG000|Participant Flow|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
11127441|NCT01738672|OG000|Outcome|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
11127442|NCT01738672|EG000|Reported Event|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
11127443|NCT01738737|BG000|Baseline|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
11127444|NCT01738737|BG001|Baseline|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
11127445|NCT01738737|BG002|Baseline|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
11127446|NCT01738737|BG003|Baseline|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
11127447|NCT01738737|BG004|Baseline|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
11127448|NCT01738737|BG005|Baseline|Total|Total of all reporting groups
11127449|NCT01738737|FG000|Participant Flow|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
11127450|NCT01738737|FG001|Participant Flow|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 9 points of application of placebo laser per knee (frontal faces, lateral and medial)"
11127451|NCT01738737|FG002|Participant Flow|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
11127452|NCT01738737|FG003|Participant Flow|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)"
11127453|NCT01738737|FG004|Participant Flow|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
11127454|NCT01738737|OG000|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
11127455|NCT01738737|OG001|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
11127456|NCT01738737|OG002|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
11127457|NCT01738737|OG003|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
11127458|NCT01738737|OG004|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
11127459|NCT01738737|EG000|Reported Event|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
11127460|NCT01738737|EG001|Reported Event|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
11127461|NCT01738737|EG002|Reported Event|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
11127462|NCT01738737|EG003|Reported Event|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
11127463|NCT01738737|EG004|Reported Event|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
11127464|NCT01738750|BG000|Baseline|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
11127465|NCT01738750|BG001|Baseline|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
11127466|NCT01738750|BG002|Baseline|Total|Total of all reporting groups
11127467|NCT01738750|FG000|Participant Flow|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
11127468|NCT01738750|FG001|Participant Flow|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
11127469|NCT01738750|OG000|Outcome|Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
11127470|NCT01738750|OG001|Outcome|No Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
11127471|NCT01738750|OG000|Outcome|Dollar Information Included|"Group of patients that will receive dollars information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Dollars Information Included"
11127472|NCT01738750|OG001|Outcome|No Dollar Information Included|Group of patients that will not receive dollar information for the laparoscopic and open surgical procedures prior to choice of procedure.
11127473|NCT01738750|EG000|Reported Event|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
11127474|NCT01738750|EG001|Reported Event|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
11127475|NCT01738919|BG000|Baseline|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
11127476|NCT01738919|BG001|Baseline|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
11127477|NCT01738919|BG002|Baseline|Total|Total of all reporting groups
11127478|NCT01738919|FG000|Participant Flow|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
11127479|NCT01738919|FG001|Participant Flow|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique"
11127480|NCT01738919|OG000|Outcome|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
11127481|NCT01738919|OG001|Outcome|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
11127482|NCT01738919|OG000|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
11127483|NCT01738919|OG001|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
11127484|NCT01738919|EG000|Reported Event|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
11127485|NCT01738919|EG001|Reported Event|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique"
11127486|NCT01738971|BG000|Baseline|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
11127487|NCT01738971|BG001|Baseline|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
11127488|NCT01738971|BG002|Baseline|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
11127489|NCT01738971|BG003|Baseline|Total|Total of all reporting groups
11127490|NCT01738971|FG000|Participant Flow|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
11127491|NCT01738971|FG001|Participant Flow|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
11127492|NCT01738971|FG002|Participant Flow|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
11127493|NCT01738971|OG000|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
11127494|NCT01738971|OG001|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
11127495|NCT01738971|OG002|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
11127496|NCT01738971|EG000|Reported Event|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
11127497|NCT01738971|EG001|Reported Event|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
11127498|NCT01738971|EG002|Reported Event|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
11127499|NCT01738984|BG000|Baseline|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
11127500|NCT01738984|BG001|Baseline|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
11127501|NCT01738984|BG002|Baseline|Total|Total of all reporting groups
11127502|NCT01738984|FG000|Participant Flow|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
11127503|NCT01738984|FG001|Participant Flow|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
11127504|NCT01738984|OG000|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
11127505|NCT01738984|OG001|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
11127506|NCT01738984|EG000|Reported Event|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
11127507|NCT01738984|EG001|Reported Event|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
11127508|NCT01739231|BG000|Baseline|Part A: ACE527 Alone|Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
11127509|NCT01739231|BG001|Baseline|Part A: ACE527 Plus dmLT|Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
11127510|NCT01739231|BG002|Baseline|Part A: Placebo|Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
11127511|NCT01739231|BG003|Baseline|Part B: ACE527 Alone|Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months and participated in Part B of the study.
11127512|NCT01739231|BG004|Baseline|Part B: ACE527 Plus dmLT|Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months and participated in Part B of the study.
11127513|NCT01739231|BG005|Baseline|Part B: Control|Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months and participated in Part B of the study, plus additional participants who did not participate in Part A.
11127514|NCT01739231|BG006|Baseline|Total|Total of all reporting groups
11127515|NCT01739231|FG000|Participant Flow|ACE527 Alone|In Part A, subjects received three oral doses of ACE527 at 0, 1, and 2 months. For Part B of the study, eligible subjects who expressed interest of the study were administered H10407 challenge strain 5-7 months after the three-dose vaccination series.
11127516|NCT01739231|FG001|Participant Flow|ACE527 Plus dmLT|In Part A, subjects received three oral doses of ACE527 with mucosal adjuvant (dmLT) at 0, 1, and 2 months. For Part B of the study, eligible subjects who expressed interest of the study were administered H10407 challenge strain 5-7 months after the three-dose vaccination series.
11127517|NCT01739231|FG002|Participant Flow|Control: Part A and B|In Part A, subjects received three oral doses of CeraVacx placebo at 0, 1, and 2 months. For Part B of the study, eligible subjects who expressed interest of the study, plus participants who had not participated in Part A, were administered H10407 challenge strain 5-7 months after the three-dose vaccination series.
11127518|NCT01739231|FG003|Participant Flow|Control: Part B Only|Participants who were recruited after Part A of the study, for Part B. Participants were administered H10407 challenge strain concurrently with other subjects in Part B.
11127519|NCT01739231|OG000|Outcome|Part A: ACE527 Alone|Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
11127520|NCT01739231|OG001|Outcome|Part A: ACE527 Plus dmLT|Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
11127521|NCT01739231|OG002|Outcome|Part A: Placebo|Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
11127522|NCT01739231|OG000|Outcome|Part A: Placebo|Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
11127523|NCT01739231|OG001|Outcome|Part A: ACE527 Alone|Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
11127524|NCT01739231|OG002|Outcome|Part A: ACE527 Plus dmLT|Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
11127525|NCT01739231|OG000|Outcome|Part B: ACE527 Alone|Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series).
11127526|NCT01739231|OG001|Outcome|Part B: ACE527 Plus dmLT|Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series).
11127527|NCT01739231|OG002|Outcome|Part B: Control|Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series), plus additional participants who did not participate in Part A.
11127528|NCT01739231|OG002|Outcome|Part B: Placebo|Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series), plus additional participants who did not participate in Part A.
11127529|NCT01739231|EG000|Reported Event|Part A: ACE527 Alone|Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
11127530|NCT01739231|EG001|Reported Event|Part A: ACE527 Plus dmLT|Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
11127531|NCT01739231|EG002|Reported Event|Part A: Placebo|Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
11127532|NCT01739231|EG003|Reported Event|Part B: ACE527 Alone|Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series).
11127533|NCT01739231|EG004|Reported Event|Part B: ACE527 Plus dmLT|Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series).
11127534|NCT01739231|EG005|Reported Event|Part B: Control|Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series), plus additional participants who did not participate in Part A.
11127535|NCT01739309|BG000|Baseline|Abemaciclib|200 mg Abemaciclib was administered orally every 12 hours on days 1 through 28 of a 28-day cycle
11127536|NCT01739309|FG000|Participant Flow|Abemaciclib|200 milligram (mg) of Abemaciclib was administered orally every 12 hours on days 1 through 28 of a 28-day cycle
11127537|NCT01739309|OG000|Outcome|Abemaciclib|200 mg Abemaciclib was administered orally every 12 hours on days 1 through 28 of a 28-day cycle.
11127538|NCT01739309|OG000|Outcome|Abemaciclib|200 mg Abemaciclib was administered orally every 12 hours on days 1 through 28 of a 28-day cycle
11127539|NCT01739309|OG000|Outcome|Abemaciclib|200 mg was Abemaciclib administered orally every 12 hours on days 1 through 28 of a 28-day cycle.
11127540|NCT01739309|EG000|Reported Event|Abemaciclib|200 milligram (mg) Abemaciclib administered orally every 12 hours on days 1 through 28 of a 28-day cycle
11127541|NCT01739335|BG000|Baseline|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
11127542|NCT01739335|BG001|Baseline|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
11127543|NCT01739335|BG002|Baseline|Total|Total of all reporting groups
11127544|NCT01739335|FG000|Participant Flow|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
11127545|NCT01739335|FG001|Participant Flow|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
11127546|NCT01739335|OG000|Outcome|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
11127547|NCT01739335|OG001|Outcome|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
11127548|NCT01739335|OG000|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo
11127549|NCT01739335|OG001|Outcome|Sugar Pill|Placebo (sugar pill) for one week
11127550|NCT01739335|OG000|Outcome|Mifepristone 600 mg/Day|600 mg/day mifepristone for one week
11127551|NCT01739335|OG000|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
11127552|NCT01739335|EG000|Reported Event|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
11127553|NCT01739335|EG001|Reported Event|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
11127554|NCT01739348|BG000|Baseline|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
11127555|NCT01739348|BG001|Baseline|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127556|NCT01739348|BG002|Baseline|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127557|NCT01739348|BG003|Baseline|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127558|NCT01739348|BG004|Baseline|Total|Total of all reporting groups
11127559|NCT01739348|FG000|Participant Flow|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
11127560|NCT01739348|FG001|Participant Flow|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127561|NCT01739348|FG002|Participant Flow|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127562|NCT01739348|FG003|Participant Flow|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127563|NCT01739348|OG000|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
11127564|NCT01739348|OG001|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127565|NCT01739348|OG002|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127566|NCT01739348|OG003|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127567|NCT01739348|EG000|Reported Event|Arm A. Verubecestat 12 mg [Part I]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study).
11127568|NCT01739348|EG001|Reported Event|Arm B. Verubecestat 40 mg [Part I]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study).
11127569|NCT01739348|EG002|Reported Event|Arm C. Verubecestat 60mg/40mg [Part I]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks).
11127570|NCT01739348|EG003|Reported Event|Arm D. Placebo [Part I]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study).
11127571|NCT01739348|EG004|Reported Event|Arm A. Verubecestat 12 mg [Part II]|[Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
11127572|NCT01739348|EG005|Reported Event|Arm B. Verubecestat 40 mg [Part II]|[Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127573|NCT01739348|EG006|Reported Event|Arm C. Verubecestat 40 mg [Part II]|[Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127574|NCT01739348|EG007|Reported Event|Arm D. Verubecestat 40 mg [Part II]|[Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
11127575|NCT01739361|BG000|Baseline|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
11127576|NCT01739361|BG001|Baseline|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
11127577|NCT01739361|BG002|Baseline|Total|Total of all reporting groups
11127578|NCT01739361|FG000|Participant Flow|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
11127579|NCT01739361|FG001|Participant Flow|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
11127580|NCT01739361|OG000|Outcome|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
11127581|NCT01739361|OG001|Outcome|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
11127582|NCT01739361|EG000|Reported Event|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
11127583|NCT01739361|EG001|Reported Event|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
11127584|NCT01739400|BG000|Baseline|DB-macitentan|All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received macitentan in the DB study (AC-055-305, NCT01743001).
11127585|NCT01739400|BG001|Baseline|DB-placebo|All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received placebo in the DB study (AC-055-305, NCT01743001).
11127586|NCT01739400|BG002|Baseline|Total|Total of all reporting groups
11127587|NCT01739400|FG000|Participant Flow|DB-macitentan|All subjects treated with macitentan in the DB study (AC-055-305, NCT01743001).
11127588|NCT01739400|FG001|Participant Flow|DB-placebo|All subjects treated with placebo in the DB study (AC-055-305, NCT01743001).
11127589|NCT01739400|OG000|Outcome|DB-macitentan|All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received macitentan in the DB study (AC-055-305, NCT01743001).
11127590|NCT01739400|OG001|Outcome|DB-placebo|All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received placebo in the DB study (AC-055-305, NCT01743001).
11127591|NCT01739400|EG000|Reported Event|All-enrolled Analysis Set|The all-enrolled analysis set includes all subjects enrolled in AC-055-308 / MAESTRO-OL (217 subjects total). All subjects received a film-coated tablet with 10mg mactientan to be taken orally on a daily basis.
11127592|NCT01739595|BG000|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11127593|NCT01739595|BG001|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11127594|NCT01739595|BG002|Baseline|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
11127595|NCT01739595|BG003|Baseline|Total|Total of all reporting groups
11127596|NCT01739595|FG000|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11127597|NCT01739595|FG001|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11127598|NCT01739595|FG002|Participant Flow|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
11127599|NCT01739595|OG000|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11127600|NCT01739595|OG001|Outcome|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
11127601|NCT01739595|EG000|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11127602|NCT01739595|EG001|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11127603|NCT01739595|EG002|Reported Event|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
11127604|NCT01739699|BG000|Baseline|Acetaminophen|"Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.~Acetaminophen"
11127605|NCT01739699|BG001|Baseline|Placebo|"Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.~Placebo"
11127606|NCT01739699|BG002|Baseline|Total|Total of all reporting groups
11127607|NCT01739699|FG000|Participant Flow|Acetaminophen|"Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.~Acetaminophen"
11127608|NCT01739699|FG001|Participant Flow|Placebo|"Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.~Placebo"
11127609|NCT01739699|OG000|Outcome|Acetaminophen|"Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.~Acetaminophen"
11127610|NCT01739699|OG001|Outcome|Placebo|"Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.~Placebo"
11127611|NCT01739699|EG000|Reported Event|Acetaminophen|"Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.~Acetaminophen"
11127612|NCT01739699|EG001|Reported Event|Placebo|"Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.~Placebo"
11127613|NCT01739764|BG000|Baseline|Vemurafenib 480mg BID|Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127614|NCT01739764|BG001|Baseline|Vemurafenib 720mg BID|Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127615|NCT01739764|BG002|Baseline|Vemurafenib 960mg BID|Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127616|NCT01739764|BG003|Baseline|Total|Total of all reporting groups
11127617|NCT01739764|FG000|Participant Flow|Vemurafenib 480mg BID|Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127618|NCT01739764|FG001|Participant Flow|Vemurafenib 720mg BID|Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127619|NCT01739764|FG002|Participant Flow|Vemurafenib 960mg BID|Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127620|NCT01739764|OG000|Outcome|Vemurafenib 480mg BID|Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127621|NCT01739764|OG001|Outcome|Vemurafenib 720mg BID|Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127622|NCT01739764|OG002|Outcome|Vemurafenib 960mg BID|Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127623|NCT01739764|EG000|Reported Event|Vemurafenib 480mg BID|Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127624|NCT01739764|EG001|Reported Event|Vemurafenib 720mg BID|Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127625|NCT01739764|EG002|Reported Event|Vemurafenib 960mg BID|Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
11127626|NCT01739790|BG000|Baseline|Sugar Pill|"Identical placebo pills twice daily for 8 weeks Placebo pills manufactured to mimic appearance of intervention drug n-acetylcysteine and prescribed with identical frequency and duration.~Placebo: Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration."
11127627|NCT01739790|BG001|Baseline|N-Acetylcysteine|"1800 mg twice daily for 8 weeks~N-Acetylcysteine: 1800 mg twice daily for 8 weeks"
11127628|NCT01739790|BG002|Baseline|Total|Total of all reporting groups
11127629|NCT01739790|FG000|Participant Flow|Placebo|Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
11127630|NCT01739790|FG001|Participant Flow|N-Acetylcysteine|1800 mg twice daily for 8 weeks
11127631|NCT01739790|OG000|Outcome|Placebo|Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
11127632|NCT01739790|OG001|Outcome|N-Acetylcysteine|1800 mg twice daily for 8 weeks
11127633|NCT01739790|EG000|Reported Event|Placebo|Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
11127634|NCT01739790|EG001|Reported Event|N-Acetylcysteine|1800 mg twice daily for 8 weeks
11127635|NCT01739803|BG000|Baseline|Intervention Group|Behavioral contract intervention
11127636|NCT01739803|BG001|Baseline|Control Group|No intervention
11127637|NCT01739803|BG002|Baseline|Total|Total of all reporting groups
11127638|NCT01739803|FG000|Participant Flow|Intervention Group|"Behavioral contract intervention.~Each participant in the intervention group met with the study pharmacist to negotiate and sign an immunosuppressant therapy (IST) adherence contract at baseline. Each intervention participant met with the study pharmacist at 3-, 6-, and 9-months post-enrollment to review his or her contract, discuss progress toward reaching the contract's goal of achieving the highest possible IST adherence, update terms of the contract if needed, and re-sign the contract for the next three-month period. At the 12-month post-enrollment meeting, the contract was terminated.~The contract included: (a) motivation(s) for achieving adherence; (b) barriers that may interfere with achieving adherence and possible solutions to overcome barriers; (c) social support available such as a significant other who may assist in following the dosing schedule; (d) tools/strategies to follow the dosing schedule; and (e) possible consequences of nonadherence"
11127639|NCT01739803|FG001|Participant Flow|Control Group|"No intervention.~The control group received standard specialty pharmacy care, which included mail or telephone reminders of monthly medication refills and an adherence packet consisting of adherence-focused educational pamphlets and a pillbox"
11127640|NCT01739803|OG000|Outcome|Intervention Group|Behavioral contract intervention
11127641|NCT01739803|OG001|Outcome|Control Group|No intervention
11127642|NCT01739803|EG000|Reported Event|Intervention Group|Behavioral contract intervention
11127643|NCT01739803|EG001|Reported Event|Control Group|No intervention
11127644|NCT01739933|BG000|Baseline|Dexmedetomidine|"Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 5 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.~Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a goal or target Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr.~Dexmedetomidine: For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 0.75 mcg/kg/hr of dexmedetomidine. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee."
11127645|NCT01739933|BG001|Baseline|Propofol|"Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 10 mg/mL propofol. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.~Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a goal or target Richmond Agitation Sedation Score set by the managing clinical team. For patients in the propofol group, dose will range from 5-50 mcg/kg/min.~Propofol: For patients in the propofol group, dose will range from 5-50 mcg/kg/min. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 25 mcg/kg/min of propofol. This dose range has been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee."
11127646|NCT01739933|BG002|Baseline|Total|Total of all reporting groups
11127647|NCT01739933|FG000|Participant Flow|Dexmedetomidine|"Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 5 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.~Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a goal or target Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr.~Dexmedetomidine: For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 0.75 mcg/kg/hr of dexmedetomidine. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee."
11127648|NCT01739933|FG001|Participant Flow|Propofol|"Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 10 mg/mL propofol. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.~Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a goal or target Richmond Agitation Sedation Score set by the managing clinical team. For patients in the propofol group, dose will range from 5-50 mcg/kg/min.~Propofol: For patients in the propofol group, dose will range from 5-50 mcg/kg/min. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 25 mcg/kg/min of propofol. This dose range has been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee."
11127649|NCT01739933|OG000|Outcome|Dexmedetomidine|"Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 5 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.~Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a goal or target Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr.~Dexmedetomidine: For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 0.75 mcg/kg/hr of dexmedetomidine. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee."
11127650|NCT01739933|OG001|Outcome|Propofol|"Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 10 mg/mL propofol. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.~Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a goal or target Richmond Agitation Sedation Score set by the managing clinical team. For patients in the propofol group, dose will range from 5-50 mcg/kg/min.~Propofol: For patients in the propofol group, dose will range from 5-50 mcg/kg/min. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 25 mcg/kg/min of propofol. This dose range has been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee."
11127651|NCT01739933|EG000|Reported Event|Dexmedetomidine|"Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 5 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.~Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a goal or target Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr.~Dexmedetomidine: For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 0.75 mcg/kg/hr of dexmedetomidine. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee."
11127652|NCT01739933|EG001|Reported Event|Propofol|"Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 10 mg/mL propofol. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.~Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a goal or target Richmond Agitation Sedation Score set by the managing clinical team. For patients in the propofol group, dose will range from 5-50 mcg/kg/min.~Propofol: For patients in the propofol group, dose will range from 5-50 mcg/kg/min. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 25 mcg/kg/min of propofol. This dose range has been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee."
11127653|NCT01740089|BG000|Baseline|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
11127654|NCT01740089|BG001|Baseline|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
11127655|NCT01740089|BG002|Baseline|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
11127656|NCT01740089|BG003|Baseline|Total|Total of all reporting groups
11127657|NCT01740089|FG000|Participant Flow|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
11127658|NCT01740089|FG001|Participant Flow|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
11127659|NCT01740089|FG002|Participant Flow|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
11127660|NCT01740089|OG000|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
11127661|NCT01740089|OG001|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
11127662|NCT01740089|OG002|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
11127663|NCT01740089|OG000|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
11127664|NCT01740089|OG001|Outcome|PegIntron (n=50)|
11127665|NCT01740089|EG000|Reported Event|Algeron (n=101)|The safety analysis included 101 patients received at least 1 dose of Algeron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [severe depression by the Beck's scale before the first injection], who was withdrawn from the mITT-analysis)
11127666|NCT01740089|EG001|Reported Event|PegIntron (n=50)|
11127667|NCT01740128|BG000|Baseline|Multimodal Then Treadmill Training|"Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
11127668|NCT01740128|BG001|Baseline|Treadmill Then Multimodal Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
11127669|NCT01740128|BG002|Baseline|Total|Total of all reporting groups
11127670|NCT01740128|FG000|Participant Flow|Multimodal Then Treadmill Training|"Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
11127671|NCT01740128|FG001|Participant Flow|Treadmill Then Multimodal Training|"Participants will undergo body weight supported treadmill training using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
11127672|NCT01740128|OG000|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
11127673|NCT01740128|OG001|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
11127674|NCT01740128|EG000|Reported Event|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
11127675|NCT01740128|EG001|Reported Event|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
11127676|NCT01740206|BG000|Baseline|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
11127677|NCT01740206|BG001|Baseline|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
11127678|NCT01740206|BG002|Baseline|Total|Total of all reporting groups
11127679|NCT01740206|FG000|Participant Flow|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
11127680|NCT01740206|FG001|Participant Flow|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
11127681|NCT01740206|OG000|Outcome|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
11127682|NCT01740206|OG001|Outcome|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
11127683|NCT01740206|EG000|Reported Event|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
11127684|NCT01740206|EG001|Reported Event|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
11127685|NCT01740258|BG000|Baseline|Bevaczimab, Radiation Therapy, Temozolomide|"In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.~If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.~If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.~If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.~Radiation Therapy~Temozolomide~Bevacizumab"
11149546|NCT01871506|BG001|Baseline|Intensive Treatment (IT)|"Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive:~Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).~Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication [varenicline, bupropion, or combination NRT (patch + lozenge)] at no cost to the participant.~Intensive Counseling: The IT model includes all components of the ST as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication."
11149547|NCT01871506|BG002|Baseline|Total|Total of all reporting groups
11127686|NCT01740258|FG000|Participant Flow|Bevaczimab, Radiation Therapy, Temozolomide|"In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.~If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.~If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.~If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.~Radiation Therapy~Temozolomide~Bevacizumab"
11127687|NCT01740258|OG000|Outcome|Bevaczimab, Radiation Therapy, Temozolomide|"In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.~If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.~If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.~If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.~Radiation Therapy~Temozolomide~Bevacizumab"
11127688|NCT01740258|EG000|Reported Event|Bevaczimab, Radiation Therapy, Temozolomide|"In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.~If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.~If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.~If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.~Radiation Therapy~Temozolomide~Bevacizumab"
11127689|NCT01740323|BG000|Baseline|Placebo|"Placebo~Placebo: daily placebo for 6 weeks"
11127690|NCT01740323|BG001|Baseline|Curcumin|"500 mg BID~Curcumin: 500 mg BID"
11127691|NCT01740323|BG002|Baseline|Total|Total of all reporting groups
11127692|NCT01740323|FG000|Participant Flow|Placebo|"Placebo~Placebo: daily placebo for 6 weeks"
11127693|NCT01740323|FG001|Participant Flow|Curcumin|"500 mg BID~Curcumin: 500 mg BID"
11127694|NCT01740323|OG000|Outcome|Placebo|"Placebo~Placebo: daily placebo for 6 weeks"
11127695|NCT01740323|OG001|Outcome|Curcumin|"500 mg BID~Curcumin: 500 mg BID"
11127696|NCT01740323|EG000|Reported Event|Placebo|"Placebo~Placebo: daily placebo for 6 weeks"
11127697|NCT01740323|EG001|Reported Event|Curcumin|"500 mg BID~Curcumin: 500 mg BID"
11127698|NCT01740362|BG000|Baseline|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
11127699|NCT01740362|BG001|Baseline|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127700|NCT01740362|BG002|Baseline|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127701|NCT01740362|BG003|Baseline|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127702|NCT01740362|BG004|Baseline|Total|Total of all reporting groups
11127703|NCT01740362|FG000|Participant Flow|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
11127704|NCT01740362|FG001|Participant Flow|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127705|NCT01740362|FG002|Participant Flow|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127706|NCT01740362|FG003|Participant Flow|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127707|NCT01740362|OG000|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
11127708|NCT01740362|OG001|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127709|NCT01740362|OG002|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127710|NCT01740362|OG003|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11224528|NCT02360488|EG001|Reported Event|In-Clinic Therapy|"The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education.~In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions."
11224529|NCT02360605|BG000|Baseline|Automated Telephone Reminder Arm|"Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.~automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.~Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1."
11224530|NCT02360605|BG001|Baseline|Prevention Coordinator Arm|"Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.~Prevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.~Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly reminder letter and then a FIT kit will be mailed the following week. Follow-up calls will follow year 1 procedure."
11224531|NCT02360605|BG002|Baseline|Total|Total of all reporting groups
11224532|NCT02360605|FG000|Participant Flow|Automated Telephone Reminder Arm|"Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.~automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.~Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1."
11224533|NCT02360605|FG001|Participant Flow|Prevention Coordinator Arm|"Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.~Prevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.~Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly reminder letter and then a FIT kit will be mailed the following week. Follow-up calls will follow year 1 procedure."
11224534|NCT02360605|OG000|Outcome|Automated Telephone Reminder Arm|"Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.~automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.~Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1."
11224535|NCT02360605|OG001|Outcome|Prevention Coordinator Arm|"Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.~prevention coordinator: patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed"
11341984|NCT03694548|OG000|Outcome|Part B Yoga Program|"Participants enrolled in Part B will receive eight in-person instructor-led group yoga sessions.~Yoga program: Instructor-led group yoga sessions (Part B): Participants enrolled in Part B will receive eight in-person instructor-led group yoga sessions. Proposed yoga session will comprise of poses, breathing exercises, and guided relaxation."
11127711|NCT01740362|EG000|Reported Event|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
11127712|NCT01740362|EG001|Reported Event|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127713|NCT01740362|EG002|Reported Event|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127714|NCT01740362|EG003|Reported Event|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
11127715|NCT01740388|BG000|Baseline|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
11127716|NCT01740388|BG001|Baseline|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
11127717|NCT01740388|BG002|Baseline|Total|Total of all reporting groups
11127718|NCT01740388|FG000|Participant Flow|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
11127719|NCT01740388|FG001|Participant Flow|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
11127720|NCT01740388|OG000|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
11127721|NCT01740388|OG001|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
11127722|NCT01740388|EG000|Reported Event|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
11127723|NCT01740388|EG001|Reported Event|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
11127724|NCT01740401|BG000|Baseline|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
11127725|NCT01740401|FG000|Participant Flow|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
11127726|NCT01740401|OG000|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
11127727|NCT01740401|EG000|Reported Event|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimuab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
11127728|NCT01740414|BG000|Baseline|MN-166 (Formerly AV411)|Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo. The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then placebo). Data are only from participants who completed both phases of the study.
11127729|NCT01740414|BG001|Baseline|Placebo|Patient began maintenance on placebo medication prior to maintenance active medication (MN-166, formerly AV411). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo, then MN-166). Data are only from participants who completed both phases of the study.
11127730|NCT01740414|BG002|Baseline|Total|Total of all reporting groups
11127731|NCT01740414|FG000|Participant Flow|MN-166 First|Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo.The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then Placebo).
11127732|NCT01740414|FG001|Participant Flow|Placebo First|Patient began maintenance on placebo medication prior to switching to the active medication condition(MN-166). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo then MN-166).
11127733|NCT01740414|OG000|Outcome|MN-166 + Oxy 0 mg|The Effects of 0 mg of oxycodone while under MN-166 maintenance.
11127734|NCT01740414|OG001|Outcome|MN-166 + Oxy 15 mg|The Effects of 15 mg of oxycodone while under MN-166 maintenance.
11127735|NCT01740414|OG002|Outcome|MN-166 + Oxy 30 mg|The Effects of 30 mg of oxycodone while under MN-166 maintenance.
11127736|NCT01740414|OG003|Outcome|Placebo + Oxy 0 mg|The Effects of 0 mg of oxycodone while under placebo maintenance.
11127737|NCT01740414|OG004|Outcome|Placebo + Oxy 15 mg|The Effects of 15 mg of oxycodone while under placebo maintenance.
11127738|NCT01740414|OG005|Outcome|Placebo + Oxy 30 mg|The Effects of 30 mg of oxycodone while under placebo maintenance.
11127739|NCT01740414|OG003|Outcome|Placebo Oxy 0 mg|The Effects of 0 mg of oxycodone while under placebo maintenance.
11127740|NCT01740414|EG000|Reported Event|MN-166 (Formerly AV411)|"Patient is receiving study drug (MN-166) first~MN-166 (formerly AV411): in one study arm, 50mg MN-166 BID are administered daily for 20 days"
11127741|NCT01740414|EG001|Reported Event|Placebo|"Patient is receiving placebo first.~placebo: In the placebo arm, the patients receive placebo for 20 days"
11127742|NCT01740440|BG000|Baseline|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
11127743|NCT01740440|FG000|Participant Flow|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
11127744|NCT01740440|OG000|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
11127745|NCT01740440|OG000|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face: BMR Face used in accordance with manufacturer IFU"
11127746|NCT01740440|EG000|Reported Event|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
11127747|NCT01740713|BG000|Baseline|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
11127748|NCT01740713|BG001|Baseline|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
11127749|NCT01740713|BG002|Baseline|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
11127750|NCT01740713|BG003|Baseline|Total|Total of all reporting groups
11127751|NCT01740713|FG000|Participant Flow|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
11127752|NCT01740713|FG001|Participant Flow|Deferiprone 50 mg/kg/da|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
11127753|NCT01740713|FG002|Participant Flow|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
11127754|NCT01740713|OG000|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
11127755|NCT01740713|OG000|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
11127756|NCT01740713|OG001|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
11127757|NCT01740713|OG002|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
11127758|NCT01740713|OG000|Outcome|Safety Population|patients who may experience adverse events occurred before or after treatment
11127759|NCT01740713|EG000|Reported Event|Deferiprone 25mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
11127760|NCT01740713|EG001|Reported Event|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
11127761|NCT01740713|EG002|Reported Event|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
11127762|NCT01740726|BG000|Baseline|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
11127763|NCT01740726|BG001|Baseline|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
11127764|NCT01740726|BG002|Baseline|Total|Total of all reporting groups
11127765|NCT01740726|FG000|Participant Flow|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
11341985|NCT03694548|OG000|Outcome|Part B Yoga Program|Participants from Part A Group 1 had the opportunity to enroll in Part B to receive eight in-person instructor-led group yoga sessions. Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions.
11127766|NCT01740726|FG001|Participant Flow|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
11127767|NCT01740726|OG000|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
11127768|NCT01740726|OG001|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
11127769|NCT01740726|EG000|Reported Event|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
11127770|NCT01740726|EG001|Reported Event|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
11127771|NCT01740791|BG000|Baseline|Placebo|Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
11127772|NCT01740791|BG001|Baseline|Velpatasvir 5 mg|Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127773|NCT01740791|BG002|Baseline|Velpatasvir 25 mg|Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127774|NCT01740791|BG003|Baseline|Velpatasvir 50 mg|Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127775|NCT01740791|BG004|Baseline|Velpatasvir 100 mg|Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
11127776|NCT01740791|BG005|Baseline|Velpatasvir 150 mg|Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127777|NCT01740791|BG006|Baseline|Total|Total of all reporting groups
11127778|NCT01740791|FG000|Participant Flow|Placebo|Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
11127779|NCT01740791|FG001|Participant Flow|Velpatasvir 5 mg|Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127780|NCT01740791|FG002|Participant Flow|Velpatasvir 25 mg|Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127781|NCT01740791|FG003|Participant Flow|Velpatasvir 50 mg|Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127782|NCT01740791|FG004|Participant Flow|Velpatasvir 100 mg|Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
11127783|NCT01740791|FG005|Participant Flow|Velpatasvir 150 mg|Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127784|NCT01740791|OG000|Outcome|Placebo|Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
11127785|NCT01740791|OG001|Outcome|Velpatasvir 5 mg|Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127786|NCT01740791|OG002|Outcome|Velpatasvir 25 mg|Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127787|NCT01740791|OG003|Outcome|Velpatasvir 50 mg|Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127788|NCT01740791|OG004|Outcome|Velpatasvir 100 mg|Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
11127789|NCT01740791|OG005|Outcome|Velpatasvir 150 mg|Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127790|NCT01740791|OG001|Outcome|Velpatasvir 5 mg (GT 1a)|Participants with genotype (GT) 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127791|NCT01740791|OG002|Outcome|Velpatasvir 25 mg (GT 1a)|Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127792|NCT01740791|OG003|Outcome|Velpatasvir 50 mg (GT 1a)|Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127793|NCT01740791|OG004|Outcome|Velpatasvir 100 mg (GT 1a)|Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
11127794|NCT01740791|OG005|Outcome|Velpatasvir 150 mg (GT 1a)|Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127795|NCT01740791|OG006|Outcome|Velpatasvir 150 mg (GT 1b)|Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127796|NCT01740791|OG007|Outcome|Velpatasvir 150 mg (GT 2)|Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127797|NCT01740791|OG008|Outcome|Velpatasvir 25 mg (GT 3)|Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127798|NCT01740791|OG009|Outcome|Velpatasvir 50 mg (GT 3)|Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127799|NCT01740791|OG010|Outcome|Velpatasvir 150 mg (GT 3)|Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127800|NCT01740791|OG011|Outcome|Velpatasvir 150 mg (GT 4)|Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127801|NCT01740791|OG001|Outcome|Velpatasvir 5 mg (GT 1a)|Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127802|NCT01740791|OG000|Outcome|Placebo (IL28B Genotype CC)|Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
11127803|NCT01740791|OG001|Outcome|Velpatasvir 5 mg (GT 1a) (IL28B Genotype CC)|Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127804|NCT01740791|OG002|Outcome|Velpatasvir 25 mg (GT 1a) (IL28B Genotype CC)|Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127805|NCT01740791|OG003|Outcome|Velpatasvir 50 mg (GT 1a) (IL28B Genotype CC)|Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127806|NCT01740791|OG004|Outcome|Velpatasvir 100 mg (GT 1a) (IL28B Genotype CC)|Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
11127807|NCT01740791|OG005|Outcome|Velpatasvir 150 mg (GT 1a) (IL28B Genotype CC)|Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127808|NCT01740791|OG006|Outcome|Velpatasvir 150 mg (GT 1b) (IL28B Genotype CC)|Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127809|NCT01740791|OG007|Outcome|Velpatasvir 150 mg (GT 2) (IL28B Genotype CC)|Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127810|NCT01740791|OG008|Outcome|Velpatasvir 25 mg (GT 3) (IL28B Genotype CC)|Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127811|NCT01740791|OG009|Outcome|Velpatasvir 50 mg (GT 3) (IL28B Genotype CC)|Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127812|NCT01740791|OG010|Outcome|Velpatasvir 150 mg (GT 3) (IL28B Genotype CC)|Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127813|NCT01740791|OG011|Outcome|Velpatasvir 150 mg (GT 4) (IL28B Genotype CC)|Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127814|NCT01740791|OG012|Outcome|Placebo (IL28B Genotype Non-CC)|Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
11127815|NCT01740791|OG013|Outcome|Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)|Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127816|NCT01740791|OG014|Outcome|Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)|Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127817|NCT01740791|OG015|Outcome|Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)|Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127818|NCT01740791|OG016|Outcome|Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)|Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
11127819|NCT01740791|OG017|Outcome|Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)|Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127820|NCT01740791|OG018|Outcome|Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)|Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127821|NCT01740791|OG019|Outcome|Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)|Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127822|NCT01740791|OG020|Outcome|Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)|Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127823|NCT01740791|OG021|Outcome|Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)|Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127824|NCT01740791|OG022|Outcome|Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)|Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127825|NCT01740791|OG023|Outcome|Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)|Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127826|NCT01740791|OG000|Outcome|Velpatasvir 5 mg|Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127827|NCT01740791|OG001|Outcome|Velpatasvir 25 mg|Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127828|NCT01740791|OG002|Outcome|Velpatasvir 50 mg|Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127829|NCT01740791|OG003|Outcome|Velpatasvir 100 mg|Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
11127830|NCT01740791|OG004|Outcome|Velpatasvir 150 mg|Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127831|NCT01740791|EG000|Reported Event|Placebo|Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
11127832|NCT01740791|EG001|Reported Event|Velpatasvir 5 mg|Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
11127833|NCT01740791|EG002|Reported Event|Velpatasvir 25 mg|Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
11127834|NCT01740791|EG003|Reported Event|Velpatasvir 50 mg|Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
11127835|NCT01740791|EG004|Reported Event|Velpatasvir 100 mg|Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
11127836|NCT01740791|EG005|Reported Event|Velpatasvir 150 mg|Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
11127837|NCT01740817|BG000|Baseline|All Study Participants|Participants who were randomized to receive either lipid or saline
11127838|NCT01740817|FG000|Participant Flow|Lipid Then Saline|Intralipid 20% 30 ml/h for 48 h, then saline 30 ml/h for 48 h
11127839|NCT01740817|FG001|Participant Flow|Saline Then Lipid|Saline infusion 30 ml/h for 48 h, then lipid 30 ml/h for 48 h
11127840|NCT01740817|OG000|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
11127841|NCT01740817|OG001|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
11127842|NCT01740817|EG000|Reported Event|Saline|Intralipid infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then saline 30 ml/h for 48 h
11127843|NCT01740817|EG001|Reported Event|Intralipid|Saline infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then Intralipid 30 ml/h for 48 h
11127844|NCT01741012|BG000|Baseline|Gardasil|"Single treatment arm:~0.5 ml single dose Gardasil vaccine given at three separate visits~Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6"
11127845|NCT01741012|FG000|Participant Flow|Gardasil|"Single treatment arm:~0.5 ml single dose Gardasil vaccine given at three separate visits~Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6"
11127846|NCT01741012|OG000|Outcome|Gardasil|"Single treatment arm:~0.5 ml single dose Gardasil vaccine given at three separate visits~Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6"
11127847|NCT01741012|OG000|Outcome|HPV Serotype Naive Women|"Single treatment arm:~0.5 ml single dose Gardasil vaccine given at three separate visits~Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6"
11127848|NCT01741012|EG000|Reported Event|Gardasil|"Single treatment arm:~0.5 ml single dose Gardasil vaccine given at three separate visits~Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6"
11127849|NCT01741259|BG000|Baseline|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
11127850|NCT01741259|BG001|Baseline|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
11127851|NCT01741259|BG002|Baseline|Total|Total of all reporting groups
11127852|NCT01741259|FG000|Participant Flow|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
11127853|NCT01741259|FG001|Participant Flow|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
11127854|NCT01741259|OG000|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
11127855|NCT01741259|OG001|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
11127856|NCT01741259|EG000|Reported Event|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
11127857|NCT01741259|EG001|Reported Event|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
11127858|NCT01741272|BG000|Baseline|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
11127859|NCT01741272|BG001|Baseline|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
11127860|NCT01741272|BG002|Baseline|Total|Total of all reporting groups
11127861|NCT01741272|FG000|Participant Flow|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
11127862|NCT01741272|FG001|Participant Flow|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
11127863|NCT01741272|OG000|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
11127864|NCT01741272|OG001|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
11127865|NCT01741272|EG000|Reported Event|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
11127866|NCT01741272|EG001|Reported Event|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
11127867|NCT01741350|BG000|Baseline|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
11127868|NCT01741350|BG001|Baseline|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
11127869|NCT01741350|BG002|Baseline|Total|Total of all reporting groups
11008110|NCT01094717|OG002|Outcome|Tazarotene and Active Excimer Laser|"patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and excimer (active) laser to randomly assigned left or right side of body psoriasis lesions.~excimer laser (active): Lesions on randomly assigned left or right side of body were treated with active excimer laser by an increasing dose level per a standard of care protocol.~Tazarotene 0.1% gel: Patients assigned to this intervention applied topical tazarotene gel 0.1% to all lesions daily."
11008111|NCT01094717|OG003|Outcome|Tazarotene and Sham Excimer Laser|"patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and sham excimer laser to randomly assigned left or right side of body psoriasis lesions.~excimer laser (sham): Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).~Acitretin 25 MG: Patients assigned to this intervention took oral acitretin 25 mg daily."
11008112|NCT01094717|EG000|Reported Event|Acitretin and Excimer|excimer vs sham excimer: half of lesions will be treated with excimer laser; half of lesions will be treated with sham excimer (opaque cover on the laser device)
11008113|NCT01094717|EG001|Reported Event|Tazarotene and Excimer|excimer vs sham excimer: half of lesions will be treated with excimer laser; half of lesions will be treated with sham excimer (opaque cover on the laser device)
11008114|NCT01094730|BG000|Baseline|All Subjects|All enrolled subjects who have the demographic data and worn at least one study lens.
11008115|NCT01094730|FG000|Participant Flow|Galyfilcon A Prototype/Marketed Galyfilcon A|The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period.
11008116|NCT01094730|FG001|Participant Flow|Marketed Galyfilcon A/Galyfilcon A Prototype|The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period.
11008117|NCT01094730|OG000|Outcome|Galyfilcon A Prototype Lens|Experimental silicone hydrogel contact lens.
11008118|NCT01094730|OG001|Outcome|Marketed Galyfilcon A Lens|Marketed silicone hydrogel contact lens.
11008119|NCT01094730|OG000|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
11008120|NCT01094730|OG001|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
11008121|NCT01094730|EG000|Reported Event|All Subjects|All subjects were to wear both lenses during the course of the study.
11008122|NCT01094743|BG000|Baseline|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
11008123|NCT01094743|FG000|Participant Flow|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
11008124|NCT01094743|OG000|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
11008125|NCT01094743|OG001|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
11008126|NCT01094743|EG000|Reported Event|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
11008127|NCT01094808|BG000|Baseline|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
11008128|NCT01094808|BG001|Baseline|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
11008129|NCT01094808|BG002|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
11008130|NCT01094808|BG003|Baseline|Total|Total of all reporting groups
11008131|NCT01094808|FG000|Participant Flow|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
11008132|NCT01094808|FG001|Participant Flow|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
11008133|NCT01094808|FG002|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
11008134|NCT01094808|OG000|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
11008135|NCT01094808|OG001|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
11008136|NCT01094808|OG002|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
11008137|NCT01094808|EG000|Reported Event|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
11008138|NCT01094808|EG001|Reported Event|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
11008139|NCT01094808|EG002|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
11008140|NCT01094886|BG000|Baseline|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
11008141|NCT01094886|FG000|Participant Flow|Rivaroxaban|10 mg PO (orally) qd (once daily) for up to 35 days for total hip replacement (THR) and 14 days for total knee replacement (TKR)
11008142|NCT01094886|OG000|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
11008143|NCT01094886|EG000|Reported Event|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
11008144|NCT01095094|BG000|Baseline|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
11008145|NCT01095094|FG000|Participant Flow|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
11008146|NCT01095094|OG000|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
11008147|NCT01095094|EG000|Reported Event|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
11008148|NCT01095497|BG000|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of SC CINRYZE twice weekly for two weeks.
11127870|NCT01741350|FG000|Participant Flow|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
11127871|NCT01741350|FG001|Participant Flow|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
11127872|NCT01741350|OG000|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
11127873|NCT01741350|OG001|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
11127874|NCT01741350|EG000|Reported Event|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program: Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
11127875|NCT01741350|EG001|Reported Event|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition: Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
11127876|NCT01741454|BG000|Baseline|Tamsulosin Plus Placebo 7 Day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day."
11127877|NCT01741454|BG001|Baseline|Tamsulosin Plus Tolterodine ER 7 Day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day.~Tolterodine ER: 4 mg by mouth once a day."
11127878|NCT01741454|BG002|Baseline|Tamsulosin Plus Placebo 21 Day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day."
11127879|NCT01741454|BG003|Baseline|Tamsulosin Plus Tolterodine ER 21 Day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day.~Tolterodine ER: 4 mg by mouth once a day."
11127880|NCT01741454|BG004|Baseline|Total|Total of all reporting groups
11127881|NCT01741454|FG000|Participant Flow|Tamsulosin Plus Placebo 7 Day|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day for 7 days"
11127882|NCT01741454|FG001|Participant Flow|Tamsulosin Plus Tolterodine ER 7 Day|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day for 7 days~Tolterodine ER: 4 mg by mouth once a day for 7 days"
11127883|NCT01741454|FG002|Participant Flow|Tamsulosin Plus Placebo 21 Day|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day for 21 days"
11127884|NCT01741454|FG003|Participant Flow|Tamsulosin Plus Tolterodine ER 21 Day|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day for 21 days~Tolterodine ER: 4 mg by mouth once a day for 21 days"
11127885|NCT01741454|OG000|Outcome|Tamsulosin Plus Placebo 7-day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day for 7 dyas"
11127886|NCT01741454|OG001|Outcome|Tamsulosin Plus Tolterodine ER 7-day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day for 7 days~Tolterodine ER: 4 mg by mouth once a day for 7 days"
11127887|NCT01741454|OG002|Outcome|Tamsulosin Plus Placebo 21-day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day for 21 dyas"
11127888|NCT01741454|OG003|Outcome|Tamsulosin Plus Tolterodine ER 21-day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day for 21days~Tolterodine ER: 4 mg by mouth once a day for 21 days"
11127889|NCT01741454|OG000|Outcome|Tamsulosin Plus Placebo 7-day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day."
11127890|NCT01741454|OG001|Outcome|Tamsulosin Plus Tolterodine ER 7-day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day.~Tolterodine ER: 4 mg by mouth once a day."
11127891|NCT01741454|OG002|Outcome|Tamsulosin Plus Placebo 21-day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day."
11127892|NCT01741454|OG003|Outcome|Tamsulosin Plus Tolterodine ER 21-day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day.~Tolterodine ER: 4 mg by mouth once a day."
11127893|NCT01741454|EG000|Reported Event|Tamsulosin Plus Placebo 7 Day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day."
11127894|NCT01741454|EG001|Reported Event|Tamsulosin Plus Tolterodine ER 7 Day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day.~Tolterodine ER: 4 mg by mouth once a day."
11127895|NCT01741454|EG002|Reported Event|Tamsulosin Plus Placebo 21 Day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tamsulosin: 0.4 mg by mouth once per day."
11127896|NCT01741454|EG003|Reported Event|Tamsulosin Plus Tolterodine ER 21 Day Treatment|"Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.~Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.~Tamsulosin: 0.4 mg by mouth once per day.~Tolterodine ER: 4 mg by mouth once a day."
11127897|NCT01741532|BG000|Baseline|Deferiprone|Deferiprone 80 mg/mL oral solution, 15 mg/kg b.i.d. for 18 months
11127898|NCT01741532|BG001|Baseline|Placebo|Matching volume of placebo solution, twice daily for 18 months
11127899|NCT01741532|BG002|Baseline|Total|Total of all reporting groups
11127900|NCT01741532|FG000|Participant Flow|Deferiprone|Patients randomized to this arm received deferiprone oral solution 80 mg/mL at a dosage of up to 15 mg/kg twice a day for up 18 months.
11127901|NCT01741532|FG001|Participant Flow|Placebo|Patients randomized to this arm received matching placebo solution twice a day, for up to 18 months, at a volume corresponding to that taken by patients who were receiving active product.
11127902|NCT01741532|OG000|Outcome|Deferiprone|Patients randomized to this arm received deferiprone oral solution 80 mg/mL at a dosage of up to 15 mg/kg twice a day for up to 18 months.
11127903|NCT01741532|OG001|Outcome|Placebo|Patients randomized to this arm received matching placebo solution twice a day, for up to 18 months, at a volume corresponding to what was given for the active product.
11127904|NCT01741532|OG000|Outcome|Deferiprone|Patients randomized to this arm received deferiprone oral solution 80 mg/mL at a dosage of up to 15 mg/kg twice a day for up 18 months.
11127905|NCT01741532|OG001|Outcome|Placebo|Patients randomized to this arm received matching placebo solution twice a day, for up to 18 months, at a volume corresponding to that taken by patients who were receiving active product.
11127906|NCT01741532|OG000|Outcome|Deferiprone|The subset of deferiprone recipients who underwent MRI R2* imaging
11127907|NCT01741532|OG001|Outcome|Placebo|The subset of placebo recipients who underwent MRI R2* imaging
11127908|NCT01741532|EG000|Reported Event|Deferiprone|Study participants who received at least one dose of deferiprone in the trial
11127909|NCT01741532|EG001|Reported Event|Placebo|Study participants who received at least one dose of placebo in the trial
11127910|NCT01741545|BG000|Baseline|Cohort A|Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
11127911|NCT01741545|BG001|Baseline|Cohort B|Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
11127912|NCT01741545|BG002|Baseline|Total|Total of all reporting groups
11127913|NCT01741545|FG000|Participant Flow|Cohort A|Participants with hepatitis C virus (HCV) genotype (GT)-2 or GT-3 infection (Cohort A) were treated with peginterferon lambda-1a (pegIFNλ-1a referred to as Lambda)/Ribavirin (RBV)/Daclatasvir (DCV). Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
11127914|NCT01741545|FG001|Participant Flow|Cohort B|Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
11127915|NCT01741545|OG000|Outcome|Cohort A|Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
11127916|NCT01741545|OG001|Outcome|Cohort B|Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
11341986|NCT03694548|OG000|Outcome|Part B Yoga Program|"Participants from Part A Group 1 had the opportunity to enroll in Part B to receive eight in-person instructor-led group yoga sessions.~Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions."
11127917|NCT01741545|EG000|Reported Event|Cohort A|Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
11127918|NCT01741545|EG001|Reported Event|Cohort B|Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
11127919|NCT01741688|BG000|Baseline|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
11127920|NCT01741688|FG000|Participant Flow|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
11127921|NCT01741688|OG000|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
11127922|NCT01741688|OG000|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
11127923|NCT01741688|EG000|Reported Event|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
11127924|NCT01741701|BG000|Baseline|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
11127925|NCT01741701|BG001|Baseline|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
11127926|NCT01741701|BG002|Baseline|Total|Total of all reporting groups
11127927|NCT01741701|FG000|Participant Flow|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
11127928|NCT01741701|FG001|Participant Flow|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
11127929|NCT01741701|OG000|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
11127930|NCT01741701|OG001|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
11127931|NCT01741701|EG000|Reported Event|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
11127932|NCT01741701|EG001|Reported Event|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
11127933|NCT01741792|BG000|Baseline|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127934|NCT01741792|BG001|Baseline|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127935|NCT01741792|BG002|Baseline|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127936|NCT01741792|BG003|Baseline|Total|Total of all reporting groups
11127937|NCT01741792|FG000|Participant Flow|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127938|NCT01741792|FG001|Participant Flow|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127939|NCT01741792|FG002|Participant Flow|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127940|NCT01741792|OG000|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127941|NCT01741792|OG001|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127942|NCT01741792|OG002|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127943|NCT01741792|OG000|Outcome|Blinatumomab 9 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day.
11127944|NCT01741792|OG001|Outcome|Blinatumomab 28 μg/d|Participants received blinatumomab CIV 28 µg/day.
11127945|NCT01741792|OG002|Outcome|Blinatumomab 112 μg/d|Participants received blinatumomab administered CIV 112 µg/day.
11127946|NCT01741792|OG000|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
11127947|NCT01741792|EG000|Reported Event|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127948|NCT01741792|EG001|Reported Event|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127949|NCT01741792|EG002|Reported Event|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127950|NCT01741792|EG003|Reported Event|Cohort 1+3: Blinatumomab 9/28/112µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
11127951|NCT01741792|EG004|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
11127952|NCT01742065|BG000|Baseline|Usual Care|Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters
11127953|NCT01742065|BG001|Baseline|Intervention|The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use.
11127954|NCT01742065|BG002|Baseline|Total|Total of all reporting groups
11127955|NCT01742065|FG000|Participant Flow|Usual Care|Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters. Usual Care clinics were offered training and intervention materials in August 2015.
11127956|NCT01742065|FG001|Participant Flow|Intervention|The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use.
11127957|NCT01742065|OG000|Outcome|Usual Care|Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters.
11127958|NCT01742065|OG001|Outcome|Intervention|The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use.
11127959|NCT01742065|EG000|Reported Event|Usual Care|Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters. Usual Care clinics were offered training and intervention materials in August 2015, and therefore patients were followed through the end of the study.
11127960|NCT01742065|EG001|Reported Event|Intervention|The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use. All patients were followed through the end of the study.
11127961|NCT01742078|BG000|Baseline|7.5 mg LY2541546 - IV|Participants received 7.5 mg LY2541546 IV
11127962|NCT01742078|BG001|Baseline|25 mg LY2541546 - IV|Participants received25 mg LY2541546 IV
11127963|NCT01742078|BG002|Baseline|75 mg LY2541546 - IV|Participants received 75 mg LY2541546 IV
11127964|NCT01742078|BG003|Baseline|225 mg LY2541546 - IV|Participants received225 mg LY541546 IV
11127965|NCT01742078|BG004|Baseline|750 mg LY2541546 - IV|Participants received750 mg LY2541546 IV
11127966|NCT01742078|BG005|Baseline|150 mg LY2541546 - SC|Participants received 150 mg LY2541546 subcutaneously (SC)
11127967|NCT01742078|BG006|Baseline|225 mg LY2541546 - IV, OL|Participants received 225 mg LY2541546 IV. Open label(OL)
11127968|NCT01742078|BG007|Baseline|750 mg LY2541546 - IV, OL|Participants received 750 mg LY2541546 IV, OL
11127969|NCT01742078|BG008|Baseline|Placebo|Participants single dose of placebo administered IV or SC
11127970|NCT01742078|BG009|Baseline|Total|Total of all reporting groups
11127971|NCT01742078|FG000|Participant Flow|7.5 mg LY2541546 - IV|Single dose of 7.5 mg LY2541546 administered intravenously (IV)
11127972|NCT01742078|FG001|Participant Flow|25 mg LY2541546 - IV|Single dose of 25 mg LY2541546 administered IV
11127973|NCT01742078|FG002|Participant Flow|75 mg LY2541546 - IV|Single dose of 75 mg LY2541546 administered IV
11127974|NCT01742078|FG003|Participant Flow|225 mg LY2541546 - IV|Single dose of 225 mg LY2541546 administered IV
11127975|NCT01742078|FG004|Participant Flow|750 mg LY2541546 - IV|Single dose of 750 mg LY2541546 administered IV
11127976|NCT01742078|FG005|Participant Flow|150 mg LY2541546 - SC|Single dose of 150 mg LY2541546 administered subcutaneous (SC)
11127977|NCT01742078|FG006|Participant Flow|225 mg LY2541546 - IV, OL|Single dose of 225 mg LY2541546 administered IV, open label (OL)
11127978|NCT01742078|FG007|Participant Flow|750 mg LY2541546 - IV, OL|Single dose of 750 mg LY2541546 administered IV, OL
11127979|NCT01742078|FG008|Participant Flow|Placebo|Single dose of placebo administered IV or SC
11127980|NCT01742078|OG000|Outcome|7.5 mg LY2541546 - IV|Single dose of 7.5 mg LY2541546 administered intravenously (IV)
11127981|NCT01742078|OG001|Outcome|25 mg LY2541546 - IV|Single dose of 25 mg LY2541546 administered IV
11127982|NCT01742078|OG002|Outcome|75 mg LY2541546 - IV|Single dose of 75 mg LY2541546 administered IV
11127983|NCT01742078|OG003|Outcome|225 mg LY2541546 - IV|Single dose of 225 mg LY2541546 administered IV
11127984|NCT01742078|OG004|Outcome|750 mg LY2541546 - IV|Single dose of 750 mg LY2541546 administered IV
11127985|NCT01742078|OG005|Outcome|150 mg LY2541546 - SC|Single dose of 150 mg LY2541546 administered subcutaneous (SC)
10879579|NCT00458484|OG006|Outcome|Series 2/Dose Level 3: Stereotactic Radiosurgery|"Dose Level 3: Radiation will be delivered in 3 fractions:~20 Gy x 3 fractions: Total of 60 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b"
11127986|NCT01742078|OG006|Outcome|Placebo|Single dose of placebo administered IV or SC
11127987|NCT01742078|OG007|Outcome|225 mg LY2541546 - IV, OL|Single dose of 225 mg LY2541546 administered IV, open label (OL)
11127988|NCT01742078|OG008|Outcome|750 mg LY2541546 - IV, OL|Single dose of 750 mg LY2541546 administered IV, OL
11127989|NCT01742078|OG006|Outcome|225 mg LY2541546 - IV, OL|Single dose of 225 mg LY2541546 administered IV, open label (OL)
11127990|NCT01742078|OG007|Outcome|750 mg LY2541546 - IV, OL|Single dose of 750 mg LY2541546 administered IV, OL
11127991|NCT01742078|EG000|Reported Event|7.5 mg LY2541546 - IV|Single dose of 7.5 mg LY2541546 administered intravenously (IV)
11127992|NCT01742078|EG001|Reported Event|25 mg LY2541546 - IV|Single dose of 25 mg LY2541546 administered IV
11127993|NCT01742078|EG002|Reported Event|75 mg LY2541546 - IV|Single dose of 75 mg LY2541546 administered IV
11127994|NCT01742078|EG003|Reported Event|225 mg LY2541546 - IV|Single dose of 225 mg LY2541546 administered IV
11127995|NCT01742078|EG004|Reported Event|750 mg LY2541546 - IV|Single dose of 750 mg LY2541546 administered IV
11127996|NCT01742078|EG005|Reported Event|150 mg LY2541546 - SC|Single dose of 150 mg LY2541546 administered subcutaneous (SC)
11127997|NCT01742078|EG006|Reported Event|Placebo|Single dose of placebo administered IV or SC
11127998|NCT01742078|EG007|Reported Event|225 mg LY2541546 - IV, OL|Single dose of 225 mg LY2541546 administered IV, open label (OL)
11127999|NCT01742078|EG008|Reported Event|750 mg LY2541546 - IV, OL|Single dose of 750 mg LY2541546 administered IV, OL
11128000|NCT01742091|BG000|Baseline|180 mg LY2541546 SC Q4W|180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
11128001|NCT01742091|BG001|Baseline|270 mg LY2541546 SC Q2W|270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
11128002|NCT01742091|BG002|Baseline|270 mg LY2541546 SC Q4W|270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
11128003|NCT01742091|BG003|Baseline|540 mg LY2541546 IV Q4W|540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
11128004|NCT01742091|BG004|Baseline|750 mg LY2541546 IV Q2W|750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
11128005|NCT01742091|BG005|Baseline|Placebo Q2W|Placebo administered IV or SC once every 2 weeks for 8 weeks.
11128006|NCT01742091|BG006|Baseline|Total|Total of all reporting groups
11128007|NCT01742091|FG000|Participant Flow|180 mg LY2541546 SC Q4W|180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
11128008|NCT01742091|FG001|Participant Flow|270 mg LY2541546 SC Q2W|270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
11128009|NCT01742091|FG002|Participant Flow|270 mg LY2541546 SC Q4W|270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
11128010|NCT01742091|FG003|Participant Flow|540 mg LY2541546 IV Q4W|540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
11128011|NCT01742091|FG004|Participant Flow|750 mg LY2541546 IV Q2W|750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
11128012|NCT01742091|FG005|Participant Flow|Placebo Q2W|Placebo administered IV or SC once every 2 weeks for 8 weeks.
11128013|NCT01742091|OG000|Outcome|180 mg LY2541546 SC Q4W|180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
11128014|NCT01742091|OG001|Outcome|270 mg LY2541546 SC Q2W|270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
11128015|NCT01742091|OG002|Outcome|270 mg LY2541546 SC Q4W|270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
11008149|NCT01095497|BG001|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
11008150|NCT01095497|BG002|Baseline|Total|Total of all reporting groups
11008151|NCT01095497|FG000|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of intravenous (IV) CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of subcutaneous (SC) CINRYZE twice weekly for two weeks.
11008152|NCT01095497|FG001|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
11008153|NCT01095497|OG000|Outcome|Intravenous (IV) CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
11008154|NCT01095497|OG001|Outcome|Subcutaneous (SC) CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
11008155|NCT01095497|OG002|Outcome|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
11008156|NCT01095497|OG000|Outcome|Intravenous (IV) CINRYZE|1000 Units of IV CYNRYZE twice weekly for two weeks
11008157|NCT01095497|OG001|Outcome|Subcutaneous (SC) CYNRYZE Dose 1|1000 Units of SC CYNRYZE twice weekly for two weeks
11008158|NCT01095497|OG002|Outcome|SC Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
11008159|NCT01095497|EG000|Reported Event|Intravenous (IV) CINRYZE|1000 Units of IV CYNRYZE twice weekly for two weeks
11008160|NCT01095497|EG001|Reported Event|Subcutaneous (SC) CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
11008161|NCT01095497|EG002|Reported Event|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
11008162|NCT01095510|BG000|Baseline|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
11008163|NCT01095510|BG001|Baseline|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
11008164|NCT01095510|BG002|Baseline|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
11008165|NCT01095510|BG003|Baseline|Total|Total of all reporting groups
11008166|NCT01095510|FG000|Participant Flow|500 U CINRYZE (10-25 kg Body Weight)|Single intravenous (IV) dose of 500 U CINRYZE
11008167|NCT01095510|FG001|Participant Flow|1000 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
11008168|NCT01095510|FG002|Participant Flow|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
11008169|NCT01095510|FG003|Participant Flow|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
11008170|NCT01095510|OG000|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
11008171|NCT01095510|OG001|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
11008172|NCT01095510|OG002|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
11008173|NCT01095510|EG000|Reported Event|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
11008174|NCT01095510|EG001|Reported Event|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
11008175|NCT01095510|EG002|Reported Event|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
11008176|NCT01095653|BG000|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008177|NCT01095653|BG001|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008178|NCT01095653|BG002|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008179|NCT01095653|BG003|Baseline|Total|Total of all reporting groups
11008180|NCT01095653|FG000|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008181|NCT01095653|FG001|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008182|NCT01095653|FG002|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008183|NCT01095653|OG000|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008184|NCT01095653|OG001|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008185|NCT01095653|OG002|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008186|NCT01095653|EG000|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008187|NCT01095653|EG001|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008188|NCT01095653|EG002|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
11008189|NCT01095666|BG000|Baseline|Placebo + Metformin|
11008190|NCT01095666|BG001|Baseline|Dapagliflozin 5 mg + Metformin|
11008191|NCT01095666|BG002|Baseline|Dapagliflozin 10 mg + Metformin|
11008192|NCT01095666|BG003|Baseline|Total|Total of all reporting groups
11008193|NCT01095666|FG000|Participant Flow|Placebo + Metformin|
11008194|NCT01095666|FG001|Participant Flow|Dapagliflozin 5 mg + Metformin|
11008195|NCT01095666|FG002|Participant Flow|Dapagliflozin 10 mg + Metformin|
11008196|NCT01095666|OG000|Outcome|Placebo + Metformin|
11008197|NCT01095666|OG001|Outcome|Dapagliflozin 5 mg + Metformin|
11008198|NCT01095666|OG002|Outcome|Dapagliflozin 10 mg + Metformin|
11128016|NCT01742091|OG003|Outcome|540 mg LY2541546 IV Q4W|540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
11128017|NCT01742091|OG004|Outcome|750 mg LY2541546 IV Q2W|750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
11128018|NCT01742091|OG005|Outcome|Placebo Q2W|Placebo administered IV or SC once every 2 weeks for 8 weeks.
11128019|NCT01742091|EG000|Reported Event|180 mg LY2541546 SC Q4W|180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
11128020|NCT01742091|EG001|Reported Event|270 mg LY2541546 SC Q2W|270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
11128021|NCT01742091|EG002|Reported Event|270 mg LY2541546 SC Q4W|270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
11128022|NCT01742091|EG003|Reported Event|540 mg LY2541546 IV Q4W|540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
11128023|NCT01742091|EG004|Reported Event|750 mg LY2541546 IV Q2W|750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
11128024|NCT01742091|EG005|Reported Event|Placebo Q2W|Placebo administered IV or SC once every 2 weeks for 8 weeks.
11128025|NCT01742117|BG000|Baseline|Genotype-Guided Therapy|"Subjects will be genotyped prospectively for CYP2C19*2, *3 and *17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele [i.e., *2 allele (heterozygous or homozygous) or *3 allele (heterozygous or homozygous)] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.~Clopidogrel: One 75 mg tablet per day by mouth for one year~Ticagrelor: One 90 mg tablet twice per day by mouth for one year"
11128026|NCT01742117|BG001|Baseline|Conventional Therapy|"Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19*2, *3 and *17 alleles after completion of one year of treatment with clopidogrel.~Clopidogrel: One 75 mg tablet per day by mouth for one year"
11128027|NCT01742117|BG002|Baseline|Total|Total of all reporting groups
11128028|NCT01742117|FG000|Participant Flow|Genotype-Guided Therapy|"Subjects will be genotyped prospectively for CYP2C19*2, *3 and *17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele [i.e., *2 allele (heterozygous or homozygous) or *3 allele (heterozygous or homozygous)] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.~Clopidogrel: One 75 mg tablet per day by mouth for one year~Ticagrelor: One 90 mg tablet twice per day by mouth for one year"
11128029|NCT01742117|FG001|Participant Flow|Conventional Therapy|"Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19*2, *3 and *17 alleles after completion of one year of treatment with clopidogrel.~Clopidogrel: One 75 mg tablet per day by mouth for one year"
11128030|NCT01742117|OG000|Outcome|Genotype-Guided Therapy|"Subjects will be genotyped prospectively for CYP2C19*2, *3 and *17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele [i.e., *2 allele (heterozygous or homozygous) or *3 allele (heterozygous or homozygous)] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.~Clopidogrel: One 75 mg tablet per day by mouth for one year~Ticagrelor: One 90 mg tablet twice per day by mouth for one year"
11128031|NCT01742117|OG001|Outcome|Conventional Therapy|"Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19*2, *3 and *17 alleles after completion of one year of treatment with clopidogrel.~Clopidogrel: One 75 mg tablet per day by mouth for one year"
11128032|NCT01742117|EG000|Reported Event|Genotype-Guided Therapy|"Subjects will be genotyped prospectively for CYP2C19*2, *3 and *17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele [i.e., *2 allele (heterozygous or homozygous) or *3 allele (heterozygous or homozygous)] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.~Clopidogrel: One 75 mg tablet per day by mouth for one year~Ticagrelor: One 90 mg tablet twice per day by mouth for one year"
11128033|NCT01742117|EG001|Reported Event|Conventional Therapy|"Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19*2, *3 and *17 alleles after completion of one year of treatment with clopidogrel.~Clopidogrel: One 75 mg tablet per day by mouth for one year"
11128034|NCT01742208|BG000|Baseline|Sotagliflozin 400 mg - Pioneer Group|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
11128035|NCT01742208|BG001|Baseline|Placebo - Expansion Group|Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
11128036|NCT01742208|BG002|Baseline|Sotagliflozin 400 mg - Expansion Group|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
11128037|NCT01742208|BG003|Baseline|Total|Total of all reporting groups
11128038|NCT01742208|FG000|Participant Flow|Sotagliflozin 400 mg - Pioneer Group|Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
11128039|NCT01742208|FG001|Participant Flow|Placebo - Expansion Group|Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
11128040|NCT01742208|FG002|Participant Flow|Sotagliflozin 400 mg - Expansion Group|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
11128041|NCT01742208|OG000|Outcome|Sotagliflozin 400 mg - Pioneer Group|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
11128042|NCT01742208|OG001|Outcome|Placebo - Expansion Group|Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
11128043|NCT01742208|OG002|Outcome|Sotagliflozin 400 mg - Expansion Group|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
11128044|NCT01742208|OG000|Outcome|Placebo - Expansion Group|Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
11128045|NCT01742208|OG001|Outcome|Sotagliflozin 400 mg - Expansion Group|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
11008199|NCT01095666|EG000|Reported Event|Placebo + Metformin|
11008200|NCT01095666|EG001|Reported Event|Dapagliflozin 5 mg + Metformin|
11008201|NCT01095666|EG002|Reported Event|Dapagliflozin 10 mg + Metformin|
11008202|NCT01095757|BG000|Baseline|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
11008203|NCT01095757|FG000|Participant Flow|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and granulocyte-colony stimulating factor (G-CSF).~Plerixafor : 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target cluster of differentiation 34 (CD34) cell dose has been reached."
11008204|NCT01095757|OG000|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
11008205|NCT01095757|OG001|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
11008206|NCT01095757|EG000|Reported Event|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
11008207|NCT01095796|BG000|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
11008208|NCT01095796|BG001|Baseline|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
11008209|NCT01095796|BG002|Baseline|Total|Total of all reporting groups
11008210|NCT01095796|FG000|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regimen (STR) once daily plus placebo to match Atripla once daily prior to bedtime
11008211|NCT01095796|FG001|Participant Flow|Atripla|Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
11008212|NCT01095796|OG000|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
11008213|NCT01095796|OG001|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
11008214|NCT01095796|EG000|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
11008215|NCT01095796|EG001|Reported Event|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
11008216|NCT01095835|BG000|Baseline|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
11008217|NCT01095835|BG001|Baseline|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
11008218|NCT01095835|BG002|Baseline|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
11008219|NCT01095835|BG003|Baseline|Total|Total of all reporting groups
11008220|NCT01095835|FG000|Participant Flow|PEG-IFN48|Treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
11008221|NCT01095835|FG001|Participant Flow|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
11008222|NCT01095835|FG002|Participant Flow|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
11008223|NCT01095835|OG000|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
11008224|NCT01095835|OG001|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
11008225|NCT01095835|OG002|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
11128046|NCT01742208|EG000|Reported Event|Sotagliflozin 400 mg - Pioneer Group|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
11128047|NCT01742208|EG001|Reported Event|Placebo - Expansion Group|Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
11128048|NCT01742208|EG002|Reported Event|Sotagliflozin 400 mg - Expansion Group|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
11128049|NCT01742286|BG000|Baseline|Fasted: Ceritinib 300 mg/m2|Participants in the fasted group who took 300 mg of ceritinib
11128050|NCT01742286|BG001|Baseline|Fasted: Ceritinib 450 mg/m2|Participants in the fasted group who took 450 mg of ceritinib
11128051|NCT01742286|BG002|Baseline|Fasted: Ceritinib 510 mg/m2|Participants in the fasted group who took 510 mg of ceritinib
11128052|NCT01742286|BG003|Baseline|Fasted: Ceritinib 560 mg/m2|Participants in the fasted group who took 560 mg of ceritinib
11128053|NCT01742286|BG004|Baseline|Fed: Ceritinib 320 mg/m2|Participants in the fed group who took 320 mg of ceritinib
11128054|NCT01742286|BG005|Baseline|Fed: Ceritinib 400 mg/m2|Participants in the fed group who took 400 mg of ceritinib
11128055|NCT01742286|BG006|Baseline|Fed: Ceritinib 500 mg/m2|Participants in the fed group who took 500 mg of ceritinib
11128056|NCT01742286|BG007|Baseline|Total|Total of all reporting groups
11128057|NCT01742286|FG000|Participant Flow|Fasted: Ceritinib 300 mg/m2|Participants in the fasted group who took 300 mg of ceritinib
11128058|NCT01742286|FG001|Participant Flow|Fasted: Ceritinib 450 mg/m2|Participants in the fasted group who took 450 mg of ceritinib
11128059|NCT01742286|FG002|Participant Flow|Fasted: Ceritinib 510 mg/m2|Participants in the fasted group who took 510 mg of ceritinib
11128060|NCT01742286|FG003|Participant Flow|Fasted: Ceritinib 560 mg/m2|Participants in the fasted group who took 560 mg of ceritinib
11128061|NCT01742286|FG004|Participant Flow|Fed: Ceritinib 320 mg/m2|Participants in the fed group who took 320 mg of ceritinib
11128062|NCT01742286|FG005|Participant Flow|Fed: Ceritinib 400 mg/m2|Participants in the fed group who took 400 mg of ceritinib
11128063|NCT01742286|FG006|Participant Flow|Fed: Ceritinib 500 mg/m2|Participants in the fed group who took 500 mg of ceritinib
11128064|NCT01742286|OG000|Outcome|Fasted: Ceritinib 300 mg/m2|Participants in the fasted group who took 300 mg of ceritinib
11128065|NCT01742286|OG001|Outcome|Fasted: Ceritinib 450 mg/m2|Participants in the fasted group who took 450 mg of ceritinib
11128066|NCT01742286|OG002|Outcome|Fasted: Ceritinib 510 mg/m2|Participants in the fasted group who took 510 mg of ceritinib
11128067|NCT01742286|OG003|Outcome|Fasted: Ceritinib 560 mg/m2|Participants in the fasted group who took 560 mg of ceritinib
11128068|NCT01742286|OG004|Outcome|Fed: Ceritinib 320 mg/m2|Participants in the fed group who took 320 mg of ceritinib
11128069|NCT01742286|OG005|Outcome|Fed: Ceritinib 400 mg/m2|Participants in the fed group who took 400 mg of ceritinib
11128070|NCT01742286|OG006|Outcome|Fed: Ceritinib 500 mg/m2|Participants in the fed group who took 500 mg of ceritinib
11128071|NCT01742286|OG000|Outcome|ALK-activated Neuroblastoma|Participants with ALK-activated neuroblastoma enrolled in the expansion part of the study and were given ceritinib once daily, continuously
11128072|NCT01742286|OG001|Outcome|ALK-activated Inflammatory Myofibroblastic Tumors (IMT)|Participants with ALK-activated IMT enrolled in the expansion part of the study who were given ceritinib once daily, continuously
11128073|NCT01742286|OG002|Outcome|ALK-activated Anaplastic Large Cell Lymphoma (ALCL)|Participants with ALK-activated ALCL enrolled in the expansion part of the study who were given ceritinib once daily, continuously
11128074|NCT01742286|OG003|Outcome|ALK-activated Other|Participants with other ALK-activated tumors enrolled in the expansion part of the study who were given ceritinib once daily, continuously
11128075|NCT01742286|OG000|Outcome|Fasted: Ceritinib 510 mg/m2|Participants in the fasted group who took 510 mg of ceritinib
11128076|NCT01742286|OG001|Outcome|Fed: Ceritinib 500 mg/m2|Participants in the fed group who took 500 mg of ceritinib
11128077|NCT01742286|EG000|Reported Event|Fasted Ceritinib 300mg/m2|Participants in the fasted group who took 300 mg of ceritinib
11128078|NCT01742286|EG001|Reported Event|Fasted Ceritinib 450mg/m2|Participants in the fasted group who took 450 mg of ceritinib
11128079|NCT01742286|EG002|Reported Event|Fasted Ceritinib 510mg/m2|Participants in the fasted group who took 510 mg of ceritinib
11128080|NCT01742286|EG003|Reported Event|Fasted Ceritinib 560mg/m2|Participants in the fasted group who took 560 mg of ceritinib
11128081|NCT01742286|EG004|Reported Event|Fed Ceritinib 320mg/m2|Participants in the fed group who took 320 mg of ceritinib
11128082|NCT01742286|EG005|Reported Event|Fed Ceritinib 400mg/m2|Participants in the fed group who took 400 mg of ceritinib
11128083|NCT01742286|EG006|Reported Event|Fed Ceritinib 500mg/m2|Participants in the fed group who took 500 mg of ceritinib
11128084|NCT01742286|EG007|Reported Event|Fasted+Fed All Patients|All participants in the Fasted and Fed groups
11128085|NCT01742364|BG000|Baseline|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128086|NCT01742364|BG001|Baseline|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
11128087|NCT01742364|BG002|Baseline|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128088|NCT01742364|BG003|Baseline|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
11128089|NCT01742364|BG004|Baseline|Total|Total of all reporting groups
11128090|NCT01742364|FG000|Participant Flow|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128091|NCT01742364|FG001|Participant Flow|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
11128092|NCT01742364|FG002|Participant Flow|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128093|NCT01742364|FG003|Participant Flow|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
11128094|NCT01742364|OG000|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128095|NCT01742364|OG001|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
11128096|NCT01742364|OG002|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128097|NCT01742364|OG003|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
11128098|NCT01742364|OG000|Outcome|Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128099|NCT01742364|EG000|Reported Event|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128100|NCT01742364|EG001|Reported Event|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
11128101|NCT01742364|EG002|Reported Event|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
11128102|NCT01742364|EG003|Reported Event|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
11128103|NCT01742832|BG000|Baseline|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
11128104|NCT01742832|BG001|Baseline|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
11128105|NCT01742832|BG002|Baseline|Total|Total of all reporting groups
11128106|NCT01742832|FG000|Participant Flow|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
11128107|NCT01742832|FG001|Participant Flow|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
11128108|NCT01742832|OG000|Outcome|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
11128109|NCT01742832|OG001|Outcome|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
11128110|NCT01742832|EG000|Reported Event|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
11128111|NCT01742832|EG001|Reported Event|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
11128112|NCT01742897|BG000|Baseline|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
11128113|NCT01742897|FG000|Participant Flow|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
11128114|NCT01742897|OG000|Outcome|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
11128115|NCT01742897|EG000|Reported Event|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
11128116|NCT01742936|BG000|Baseline|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek: Hand held coagulation monitor.~Hospital Laboratory: Coagulation testing done by hospital laboratory."
11128117|NCT01742936|BG001|Baseline|Cardiac Bypass|"Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek: Hand held coagulation monitor.~Hospital Laboratory: Coagulation testing done by hospital laboratory."
11128118|NCT01742936|BG002|Baseline|Total|Total of all reporting groups
11128119|NCT01742936|FG000|Participant Flow|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
11128120|NCT01742936|FG001|Participant Flow|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
11128121|NCT01742936|OG000|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
11128122|NCT01742936|OG001|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
11128123|NCT01742936|EG000|Reported Event|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
11128124|NCT01742936|EG001|Reported Event|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
11128125|NCT01742949|BG000|Baseline|All Participants|All Participants as this is a crossover trial where participant will experience both heated humidification (ThermoSmart On) or dry CPAP/APAP (ThermoSmart Off)
11128126|NCT01742949|FG000|Participant Flow|Thermosmart On, Then Followed by ThermoSmart Off|Subjects receive heated humidification (ThermoSmart) first, then followed by it off.
11128127|NCT01742949|FG001|Participant Flow|ThermoSmart Off, Then Followed by ThermoSmart On|Subjects receive dry CPAP/APAP (no ThermoSmart), then followed by it on.
11128128|NCT01742949|OG000|Outcome|Thermosmart|"Subjects receive heated humidification~Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On"
11128129|NCT01742949|OG001|Outcome|No Humidification|"Subjects use dry CPAP / APAP~No Humidification: Heated Humidification (ThermoSmart) Turn Off"
11128130|NCT01742949|OG000|Outcome|Thermosmart|Subjects preferring ThermoSmart
11128131|NCT01742949|OG001|Outcome|No Humidification|Subjects preferring No ThermoSmart
11128132|NCT01742949|OG002|Outcome|No Preference|No Preference for ThermoSmart or no ThermoSmart
11128133|NCT01742949|EG000|Reported Event|Thermosmart|"Subjects receive heated humidification~Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On"
11128134|NCT01742949|EG001|Reported Event|No Humidification|"Subjects use dry CPAP / APAP~No Humidification: Heated Humidification (ThermoSmart) Turn Off"
11128135|NCT01743001|BG000|Baseline|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
11128136|NCT01743001|BG001|Baseline|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
11128137|NCT01743001|BG002|Baseline|Total|Total of all reporting groups
11128138|NCT01743001|FG000|Participant Flow|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
11128139|NCT01743001|FG001|Participant Flow|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
11128140|NCT01743001|OG000|Outcome|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
11128141|NCT01743001|OG001|Outcome|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
11128142|NCT01743001|EG000|Reported Event|Macitentan|Subjects receive macitentan 10 mg orally to be taken once daily. 114 subjects were exposed to Macitentan 10 mg for 15.93 weeks on average.
11128143|NCT01743001|EG001|Reported Event|Placebo|Subjects receive macitentan-matching placebo orally to be taken once daily. 112 subjects were exposed to placebo for 15.96 weeks on average.
11128144|NCT01743027|BG000|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128145|NCT01743027|BG001|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128146|NCT01743027|BG002|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128147|NCT01743027|BG003|Baseline|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128148|NCT01743027|BG004|Baseline|Total|Total of all reporting groups
11128149|NCT01743027|FG000|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128150|NCT01743027|FG001|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128151|NCT01743027|FG002|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128152|NCT01743027|FG003|Participant Flow|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128153|NCT01743027|OG000|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128154|NCT01743027|OG001|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128155|NCT01743027|OG002|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128156|NCT01743027|OG003|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128157|NCT01743027|EG000|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128158|NCT01743027|EG001|Reported Event|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128159|NCT01743027|EG002|Reported Event|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128160|NCT01743027|EG003|Reported Event|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
11128161|NCT01743040|BG000|Baseline|Overall Study|All patients enrolled in TURBULENCE study
11128162|NCT01743040|FG000|Participant Flow|Overall Study|All patients enrolled in TURBULENCE study
11128163|NCT01743040|OG000|Outcome|Overall Study|All patients enrolled in TURBULENCE study
11128164|NCT01743040|EG000|Reported Event|Overall Study|All patients enrolled in TURBULENCE study
11128165|NCT01743092|BG000|Baseline|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
11128166|NCT01743092|BG001|Baseline|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
11128167|NCT01743092|BG002|Baseline|Total|Total of all reporting groups
11128168|NCT01743092|FG000|Participant Flow|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
11128169|NCT01743092|FG001|Participant Flow|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
11128170|NCT01743092|OG000|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
11128171|NCT01743092|OG001|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
11128172|NCT01743092|EG000|Reported Event|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
11128173|NCT01743092|EG001|Reported Event|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
11128174|NCT01743131|BG000|Baseline|Matched Unrelated Donor - Randomized to Abatacept|"A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128175|NCT01743131|BG001|Baseline|Matched Unrelated Donor - Randomized to Placebo|"A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128176|NCT01743131|BG002|Baseline|Mismatched Unrelated Donor - Received Abatacept|"Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128177|NCT01743131|BG003|Baseline|Mismatched Unrelated Donor - CIBMTR Control (No ATG)|CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
11128178|NCT01743131|BG004|Baseline|Total|Total of all reporting groups
11128179|NCT01743131|FG000|Participant Flow|Matched Unrelated Donor - Randomized to Abatacept|"A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128180|NCT01743131|FG001|Participant Flow|Matched Unrelated Donor - Randomized to Placebo|"A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128181|NCT01743131|FG002|Participant Flow|Mismatched Unrelated Donor - Received Abatacept|"Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128182|NCT01743131|FG003|Participant Flow|Mismatched Unrelated Donor - Received Placebo|"Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128183|NCT01743131|FG004|Participant Flow|Mismatched Unrelated Donor - CIBMTR Control (No ATG)|CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
11128184|NCT01743131|OG000|Outcome|Matched Unrelated Donor - Randomized to Abatacept|"A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128185|NCT01743131|OG001|Outcome|Matched Unrelated Donor - Randomized to Placebo|"A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128186|NCT01743131|OG002|Outcome|Mismatched Unrelated Donor - Received Abatacept|"Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128187|NCT01743131|OG003|Outcome|Mismatched Unrelated Donor - CIBMTR Control (No ATG)|CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
11128188|NCT01743131|EG000|Reported Event|Matched Unrelated Donor - Randomized to Abatacept|"A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128189|NCT01743131|EG001|Reported Event|Matched Unrelated Donor - Randomized to Placebo|"A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128190|NCT01743131|EG002|Reported Event|Mismatched Unrelated Donor - Received Abatacept|"Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).~Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate."
11128191|NCT01743469|BG000|Baseline|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128192|NCT01743469|BG001|Baseline|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128193|NCT01743469|BG002|Baseline|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128194|NCT01743469|BG003|Baseline|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128195|NCT01743469|BG004|Baseline|Total|Total of all reporting groups
11128196|NCT01743469|FG000|Participant Flow|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128197|NCT01743469|FG001|Participant Flow|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128198|NCT01743469|FG002|Participant Flow|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128199|NCT01743469|FG003|Participant Flow|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128200|NCT01743469|OG000|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128201|NCT01743469|OG001|Outcome|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128202|NCT01743469|OG002|Outcome|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128203|NCT01743469|OG003|Outcome|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128204|NCT01743469|EG000|Reported Event|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128205|NCT01743469|EG001|Reported Event|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128206|NCT01743469|EG002|Reported Event|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128207|NCT01743469|EG003|Reported Event|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
11128208|NCT01743521|BG000|Baseline|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128209|NCT01743521|BG001|Baseline|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128210|NCT01743521|BG002|Baseline|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128211|NCT01743521|BG003|Baseline|No Group Allocated|Early treatment discontinuation or non-responder
11128212|NCT01743521|BG004|Baseline|Total|Total of all reporting groups
11128213|NCT01743521|FG000|Participant Flow|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128214|NCT01743521|FG001|Participant Flow|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128215|NCT01743521|FG002|Participant Flow|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128216|NCT01743521|FG003|Participant Flow|No Group Allocated|Early treatment discontinuation or non-responder (participants in whom therapy was terminated at week 4 due to HCV RNA >1000 IU/mL or week 8 due to detectable HCV RNA)
11128217|NCT01743521|OG000|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128218|NCT01743521|OG001|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128219|NCT01743521|OG002|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128220|NCT01743521|EG000|Reported Event|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11341987|NCT03694548|EG000|Reported Event|Part A Group 1: Adolescent SCD Patients Survey|"Adolescent Sickle Cell Disease (SCD) Patients with chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.~Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program."
11224536|NCT02360605|OG000|Outcome|Automated Telephone Reminder Arm|"Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.~automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions."
11224537|NCT02360605|OG001|Outcome|Prevention Coordinator Arm|"Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.~prevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.~Annual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months."
11224538|NCT02360605|EG000|Reported Event|Automated Telephone Reminder Arm|"Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.~automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.~Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1."
11341988|NCT03694548|EG001|Reported Event|Part A Group 2: Parents of Adolescent SCD Patients Survey|"Parents of adolescent SCD Patients with chronic pain from Group 1 completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.~Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program."
11008226|NCT01095835|OG000|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
11008227|NCT01095835|EG000|Reported Event|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
11008228|NCT01095835|EG001|Reported Event|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
11008229|NCT01095835|EG002|Reported Event|PEG-IFN + LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
11008230|NCT01095887|BG000|Baseline|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
11008231|NCT01095887|FG000|Participant Flow|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
11008232|NCT01095887|OG000|Outcome|Eculizumab|Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
11008233|NCT01095887|EG000|Reported Event|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
11008234|NCT01095978|BG000|Baseline|Klacid SR|The per-protocol population (2800 participants) with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
11008235|NCT01095978|FG000|Participant Flow|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
11008236|NCT01095978|OG000|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
11008237|NCT01095978|OG001|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
11008238|NCT01095978|OG002|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
11008239|NCT01095978|EG000|Reported Event|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
11008240|NCT01096017|BG000|Baseline|All Study Participants|
11008241|NCT01096017|FG000|Participant Flow|Salbutamol First, Then Terbutaline|Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
11008242|NCT01096017|FG001|Participant Flow|Terbutaline First, Then Salbutamol|Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler®
11008243|NCT01096017|OG000|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
11008244|NCT01096017|OG001|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
11008245|NCT01096017|EG000|Reported Event|Salbutamol pMDI|200 μg, inhalation, single dose.
11008246|NCT01096017|EG001|Reported Event|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose.
11008247|NCT01096056|BG000|Baseline|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
11008248|NCT01096056|BG001|Baseline|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
11008249|NCT01096056|BG002|Baseline|Total|Total of all reporting groups
11008250|NCT01096056|FG000|Participant Flow|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
11008251|NCT01096056|FG001|Participant Flow|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
11008252|NCT01096056|OG000|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
11008253|NCT01096056|OG001|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
11008254|NCT01096056|EG000|Reported Event|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
11008255|NCT01096056|EG001|Reported Event|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
11341989|NCT03694548|EG002|Reported Event|Part B Adolescent SCD Patients Yoga Program|Participants from Part A Group 1 had the opportunity to enroll in Part B to receive eight in-person instructor-led group yoga sessions. Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions.
11008256|NCT01096160|BG000|Baseline|Panel A: MK-8266 BID, 1 mg|MK-8266 BID 1 mg, administered as oral capsules (0.7 mg AM + 0.3 mg PM) for 10 days, or as matching placebo
11008257|NCT01096160|BG001|Baseline|Panel A: Placebo BID|Matching placebo capsules, administered orally for 10 days
11008258|NCT01096160|BG002|Baseline|Panel B: MK-8266 BID, 1.8 mg|MK-8266 BID 1 mg, administered as oral capsules (1 mg AM + 0.8 mg PM) for 10 days
11008259|NCT01096160|BG003|Baseline|Panel B: Placebo BID|Matching placebo capsules, administered orally for 10 days
11008260|NCT01096160|BG004|Baseline|Panel C: MK-8266 TID, 1.8 mg|MK-8266 TID 1.8 mg, administered as oral capsules (0.6 mg q6hr) for 10 days
11008261|NCT01096160|BG005|Baseline|Panel C: Placebo TID|Matching placebo capsules, administered orally for 10 days
11008262|NCT01096160|BG006|Baseline|Panel D: MK-8266 TID, 2.4 mg|MK-8266 TID 2.4 mg, administered as oral capsules (0.8 mg q6hr) for 10 days
11008263|NCT01096160|BG007|Baseline|Panel D: Placebo TID|Matching placebo capsules, administered orally for 10 days
11008264|NCT01096160|BG008|Baseline|Panel E: MK-8266 TID, 2.4 mg|MK-8266 TID 2.4 mg, administered as oral capsules (0.8 mg q6hr) for 10 days
11008265|NCT01096160|BG009|Baseline|Panel E: Placebo TID|Matching placebo capsules, administered orally for 10 days
11008266|NCT01096160|BG010|Baseline|Total|Total of all reporting groups
11008267|NCT01096160|FG000|Participant Flow|Panel A: MK-8266 BID (1 mg)|MK-8266 BID 1 mg, administered as oral capsules (0.7 mg AM + 0.3 mg PM) for 10 days
11008268|NCT01096160|FG001|Participant Flow|Panel A: Placebo BID|Matching placebo capsules, administered orally for 10 days
11008269|NCT01096160|FG002|Participant Flow|Panel B: MK-8266 BID (1.8 mg)|MK-8266 BID 1.8 mg, administered as oral capsules (1 mg AM + 0.8 mg PM) for 10 days
11008270|NCT01096160|FG003|Participant Flow|Panel B: Placebo BID|Matching placebo capsules, administered orally BID for 10 days
11008271|NCT01096160|FG004|Participant Flow|Panel C: MK-8266 TID (1.8 mg)|MK-8266 0.6 mg TID, administered as oral capsules (1.8 mg) for 10 days
11008272|NCT01096160|FG005|Participant Flow|Panel C: Placebo TID|Matching placebo capsules, administered orally TID for 10 days
11008273|NCT01096160|FG006|Participant Flow|Panel D: MK-8266 TID (2.4 mg)|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days
11008274|NCT01096160|FG007|Participant Flow|Panel D: Placebo TID|Matching placebo capsules, administered orally TID for 10 days
11008275|NCT01096160|FG008|Participant Flow|Panel E: MK-8266 TID (2.4 mg)|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days
11008276|NCT01096160|FG009|Participant Flow|Panel E: Placebo TID|Matching placebo capsules, administered orally TID for 10 days
11008277|NCT01096160|OG000|Outcome|Panel A: MK-8266 BID (1 mg)|MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days
11008278|NCT01096160|OG001|Outcome|Panel A: Placebo|Matching placebo capsules, administered orally BID for 10 days
11008279|NCT01096160|OG002|Outcome|Panel B: MK-8266 BID (1.8 mg)|MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days
11128221|NCT01743521|EG001|Reported Event|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128222|NCT01743521|EG002|Reported Event|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
11128223|NCT01743560|BG000|Baseline|Everolimus and Exemestane|Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
11128224|NCT01743560|FG000|Participant Flow|Everolimus and Exemestane|Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
11128225|NCT01743560|OG000|Outcome|Everolimus and Exemestane|Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
11128226|NCT01743560|OG000|Outcome|Week 12|Change from baseline at week 12
11128227|NCT01743560|OG001|Outcome|Week 24|Change from baseline at Week 24
11128228|NCT01743560|OG002|Outcome|Week 36|Change from baseline at week 36
11128229|NCT01743560|OG003|Outcome|Week 48|Change from baseline at week 48
11128230|NCT01743560|OG000|Outcome|Day 1|Baseline
11128231|NCT01743560|OG001|Outcome|Week 12|
11128232|NCT01743560|OG002|Outcome|Week 24|
11128233|NCT01743560|OG003|Outcome|Week 36|
11128234|NCT01743560|OG004|Outcome|Week 48|
11128235|NCT01743560|EG000|Reported Event|Everolimus + Exemestane|Everolimus + Exemestane
11128236|NCT01743677|BG000|Baseline|Entire Study Population|Includes participants randomized to receive any treatment (CP-690,550 100 mg first, moxifloxacin 400 mg first, or placebo first).
11128237|NCT01743677|FG000|Participant Flow|CP-690,550 100 mg Then Placebo Then Moxifloxacin 400 mg|Single oral dose of CP-690,550 100 milligram (mg) (5 x 20 mg tablets) in first intervention period; followed by single oral dose of placebo matched to CP-690,550 tablets in second intervention period; and single oral dose of moxifloxacin 400 mg tablet in third intervention period. A washout period of at least 7 days was maintained between each intervention period.
11128238|NCT01743677|FG001|Participant Flow|CP-690,550 100 mg Then Moxifloxacin 400 mg Then Placebo|Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in first intervention period; followed by single oral dose of moxifloxacin 400 mg tablet in second intervention period; and single oral dose of placebo matched to CP-690,550 tablets in third intervention period. A washout period of at least 7 days was maintained between each intervention period.
11128239|NCT01743677|FG002|Participant Flow|Placebo Then CP-690,550 100 mg Then Moxifloxacin 400 mg|Single oral dose of placebo matched to CP-690,550 tablets in first intervention period; followed by single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in second intervention period; and single oral dose of moxifloxacin 400 mg tablet in third intervention period. A washout period of at least 7 days was maintained between each intervention period.
11128240|NCT01743677|FG003|Participant Flow|Placebo Then Moxifloxacin 400 mg Then CP-690,550 100 mg|Single oral dose of placebo matched to CP-690,550 tablets in first intervention period; followed by single oral dose of moxifloxacin 400 mg tablet in second intervention period; and single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in third intervention period. A washout period of at least 7 days was maintained between each intervention period.
11128241|NCT01743677|FG004|Participant Flow|Moxifloxacin 400 mg Then CP-690,550 100 mg Then Placebo|Single oral dose of moxifloxacin 400 mg tablet in first intervention period; followed by single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in second intervention period; and single oral dose of placebo matched to CP-690,550 tablets in third intervention period. A washout period of at least 7 days was maintained between each intervention period.
11128242|NCT01743677|FG005|Participant Flow|Moxifloxacin 400 mg Then Placebo Then CP-690,550 100 mg|Single oral dose of moxifloxacin 400 mg tablet in first intervention period; followed by single oral dose of placebo matched to CP-690,550 tablets in second intervention period; and single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in third intervention period. A washout period of at least 7 days was maintained between each intervention period.
11128243|NCT01743677|OG000|Outcome|CP-690,550 100 mg|Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
11128244|NCT01743677|OG001|Outcome|Placebo|Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
11128245|NCT01743677|OG000|Outcome|Moxifloxacin 400 mg|Single oral dose of moxifloxacin 400 mg tablet in any intervention period.
11128246|NCT01743677|OG001|Outcome|Placebo|Single oral dose of placebo matched to moxifloxacin 400 mg in any intervention period.
11128247|NCT01743677|OG000|Outcome|CP-690,550 100 mg|Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in all intervention periods.
11128248|NCT01743677|EG000|Reported Event|CP-690,550 100 mg|Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
11128249|NCT01743677|EG001|Reported Event|Placebo|Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
11008280|NCT01096160|OG003|Outcome|Panel B: Placebo|Matching placebo capsules, administered orally BID for 10 days
11008281|NCT01096160|OG004|Outcome|Panel C: MK-8266 TID (1.8 mg)|MK-8266 0.6 mg TID, administered as oral capsules (1.8 mg) for 10 days
11008282|NCT01096160|OG005|Outcome|Panel C: Placebo|Matching placebo capsules, administered orally TID for 10 days
11008283|NCT01096160|OG006|Outcome|Panel D: MK-8266 TID (2.4 mg)|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days
11008284|NCT01096160|OG007|Outcome|Panel D: Placebo|Matching placebo capsules, administered orally TID for 10 days
11008285|NCT01096160|OG008|Outcome|Panel E: MK-8266 TID (2.4 mg)|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days
11008286|NCT01096160|OG009|Outcome|Panel E: Placebo|Matching placebo capsules, administered orally TID for 10 days
11008287|NCT01096160|OG004|Outcome|Panel C: MK-8266 TID, 1.8 mg|MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days
11008288|NCT01096160|OG008|Outcome|Panel E: MK-8266 2.4 mg TID|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days
11008289|NCT01096160|OG000|Outcome|Panel A: MK-8266 BID, 1 mg|MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days
11008290|NCT01096160|OG001|Outcome|Panel B: MK-8266 BID, 1.8 mg|MK-8266 1.8 mg (1 mg AM+ 0.8 mg PM), administered orally for 10 days
11008291|NCT01096160|OG002|Outcome|Panel C: MK-8266 TID, 1.8 mg|MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days
11008292|NCT01096160|OG003|Outcome|Panels D & E Combined: MK-8266 TID, 2.4 mg|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.
11008293|NCT01096160|OG004|Outcome|Pooled Placebo|Matching placebo capsules from Panels A, B, C, D & E, administered orally BID or TID for 10 days
11008294|NCT01096160|OG001|Outcome|Panel B: MK-8266 BID (1.8 mg)|MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days
11008295|NCT01096160|OG002|Outcome|Panel C: MK-8266 TID (1.8 mg)|MK-8266 0.6 mg TID, administered as oral capsules (1.8 mg) for 10 days
11008296|NCT01096160|OG003|Outcome|Panels D & E Combined: MK-8266 TID: MK-8266 TID (2.4 mg)|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.
11008297|NCT01096160|OG004|Outcome|Pooled Placebo|Matching placebo capsules, administered orally TID for 10 days
11008298|NCT01096160|OG000|Outcome|Panels D & E Combined: MK-8266 TID (2.4 mg)|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.
11008299|NCT01096160|OG001|Outcome|Placebo|Matching placebo capsules, administered orally TID for 10 days
11008300|NCT01096160|EG000|Reported Event|Panel A: MK-8266 BID, 1 mg|MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days
11008301|NCT01096160|EG001|Reported Event|Panel A: Placebo BID|Matching placebo capsules, administered orally BID for 10 days
11008302|NCT01096160|EG002|Reported Event|Panel B: MK-8266 BID, 1.8 mg|MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days
11008303|NCT01096160|EG003|Reported Event|Panel B: Placebo BID|Matching placebo capsules, administered orally BID for 10 days
11008304|NCT01096160|EG004|Reported Event|Panel C: MK-8266 TID, 1.8 mg|MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days
11008305|NCT01096160|EG005|Reported Event|Panel C: Placebo TID|Matching placebo capsules, administered orally TID for 10 days
11008306|NCT01096160|EG006|Reported Event|Panel D: MK-8266 TID, 2.4 mg|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days
11008307|NCT01096160|EG007|Reported Event|Panel D: Placebo TID|Matching placebo capsules, administered orally TID for 10 days
11008308|NCT01096160|EG008|Reported Event|Panel E: MK-8266 TID, 2.4 mg|MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days
11008309|NCT01096160|EG009|Reported Event|Panel E: Placebo TID|Matching placebo capsules, administered orally TID for 10 days
11008310|NCT01096186|BG000|Baseline|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
11008311|NCT01096186|FG000|Participant Flow|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
11008312|NCT01096186|OG000|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
11008313|NCT01096186|EG000|Reported Event|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
11008314|NCT01096290|BG000|Baseline|Lubiprostone 24mcg BID for 30 Days|"Active medication~lubiprostone: 24mcg BID, capsule, oral 30days"
11008315|NCT01096290|BG001|Baseline|Placebo|"Placebo, matched, blinded~Matched placebo: Twice daily for 30days, oral"
11008316|NCT01096290|BG002|Baseline|Total|Total of all reporting groups
11008317|NCT01096290|FG000|Participant Flow|Lubiprostone 24mcg BID for 30 Days|"Active medication~lubiprostone: 24mcg BID, capsule, oral 30days"
11008318|NCT01096290|FG001|Participant Flow|Placebo|"Placebo, matched, blinded~Matched placebo: Twice daily for 30days, oral"
11008319|NCT01096290|OG000|Outcome|Lubiprostone 24mcg BID for 30 Days|"Active medication~lubiprostone: 24mcg BID, capsule, oral 30days"
11008320|NCT01096290|OG001|Outcome|Placebo|"Placebo, matched, blinded~Matched placebo: Twice daily for 30days, oral"
11008321|NCT01096290|EG000|Reported Event|Lubiprostone 24mcg BID for 30 Days|"Active medication~lubiprostone: 24mcg BID, capsule, oral 30days"
11008322|NCT01096290|EG001|Reported Event|Placebo|"Placebo, matched, blinded~Matched placebo: Twice daily for 30days, oral"
11008323|NCT01096316|BG000|Baseline|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
11128250|NCT01743677|EG002|Reported Event|Moxifloxacin|Single oral dose of moxifloxacin 400 mg tablet in any intervention period.
11008324|NCT01096316|BG001|Baseline|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
11008325|NCT01096316|BG002|Baseline|Total|Total of all reporting groups
11008326|NCT01096316|FG000|Participant Flow|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
11008327|NCT01096316|FG001|Participant Flow|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
11008328|NCT01096316|OG000|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
11008329|NCT01096316|OG001|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
11008330|NCT01096316|EG000|Reported Event|Intervention|"The intervention will integrate care between a depression care manager(DCM), consulting study team (psychiatry OB-GYN physician) and OB-GYN clinic providers.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). The DCM in a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the 12-month intervention. Patients choose either medication or Problem-Solving Treatment. Depressive symptoms are assessed at each visit with the PHQ-9. Patients with inadequate response after 4 to 8 weeks to the first choice will switch or combine treatments. DCMs partcipate in weekly caseload review with a psychiatrist and Ob-Gyn physician who make treatment recommendations that the DCM then communicates to the patient's own Ob-Gyn physician who writes all prescriptions."
11008331|NCT01096316|EG001|Reported Event|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
11008332|NCT01096342|BG000|Baseline|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11008333|NCT01096342|FG000|Participant Flow|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11008334|NCT01096342|OG000|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11008335|NCT01096342|EG000|Reported Event|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11008336|NCT01096446|BG000|Baseline|Standard Infusion|Infants randomized into the experimental group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
11008337|NCT01096446|BG001|Baseline|Higher Infusion|Infants randomized into the control group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
11128251|NCT01743729|BG000|Baseline|Lifitegrast|
11128252|NCT01743729|BG001|Baseline|Placebo|
11128253|NCT01743729|BG002|Baseline|Total|Total of all reporting groups
11128254|NCT01743729|FG000|Participant Flow|Lifitegrast|
11128255|NCT01743729|FG001|Participant Flow|Placebo|
11128256|NCT01743729|OG000|Outcome|Lifitegrast|
11128257|NCT01743729|OG001|Outcome|Placebo|
11128258|NCT01743729|EG000|Reported Event|Lifitegrast|
11128259|NCT01743729|EG001|Reported Event|Placebo|
11128260|NCT01743859|BG000|Baseline|Azacitidine + Lenalidomide + Off Therapy|"Patients will receive 7 days of azacitidine followed by 3 weeks of lenalidomide. They will then have 2 weeks off therapy, for a maximum of 12 cycles.~Azacitidine: Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone.~Lenalidomide: Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28.~Off Therapy: 2 weeks off therapy, then begin sequence again for 12 weeks."
11128261|NCT01743859|FG000|Participant Flow|Azacitidine + Lenalidomide + Off Therapy|Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
11128262|NCT01743859|OG000|Outcome|Azacitidine + Lenalidomide + Off Therapy|Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
11128263|NCT01743859|EG000|Reported Event|Azacitidine + Lenalidomide + Off Therapy|Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
11128264|NCT01743963|BG000|Baseline|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
11128265|NCT01743963|BG001|Baseline|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
11128266|NCT01743963|BG002|Baseline|Total|Total of all reporting groups
11128267|NCT01743963|FG000|Participant Flow|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
11128268|NCT01743963|FG001|Participant Flow|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
11128269|NCT01743963|OG000|Outcome|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
11128270|NCT01743963|OG001|Outcome|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
11128271|NCT01743963|EG000|Reported Event|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
11128272|NCT01743963|EG001|Reported Event|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
11128273|NCT01743976|BG000|Baseline|Donepezil|"donepezil 5 mg every day~Donepezil: donepezil 5 mg once daily for 6 weeks"
11128274|NCT01743976|BG001|Baseline|Placebo|"Placebo (sugar pill) every day~Placebo: placebo or sugar pill will be taken once daily for 6 weeks"
11128275|NCT01743976|BG002|Baseline|Total|Total of all reporting groups
11128276|NCT01743976|FG000|Participant Flow|Donepezil|"donepezil 5 mg every day~Donepezil: donepezil 5 mg once daily for 6 weeks"
11128277|NCT01743976|FG001|Participant Flow|Placebo|"Placebo (sugar pill) every day~Placebo: placebo or sugar pill will be taken once daily for 6 weeks"
11128278|NCT01743976|OG000|Outcome|Donepezil|"donepezil 5 mg every day~Donepezil: donepezil 5 mg once daily for 6 weeks"
11128279|NCT01743976|OG001|Outcome|Placebo|"Placebo (sugar pill) every day~Placebo: placebo or sugar pill will be taken once daily for 6 weeks"
11128280|NCT01743976|EG000|Reported Event|Donepezil|"donepezil 5 mg every day~Donepezil: donepezil 5 mg once daily for 6 weeks"
11128281|NCT01743976|EG001|Reported Event|Placebo|"Placebo (sugar pill) every day~Placebo: placebo or sugar pill will be taken once daily for 6 weeks"
11128282|NCT01743989|BG000|Baseline|Nilotinib 24-month Treatment|Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase
11128283|NCT01743989|BG001|Baseline|Nilotinib 36-month Treatment|Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase
11128284|NCT01743989|BG002|Baseline|Not Randomized|Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized.
11128285|NCT01743989|BG003|Baseline|Total|Total of all reporting groups
11128286|NCT01743989|FG000|Participant Flow|Nilotinib 24-month Treatment|Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase
11128287|NCT01743989|FG001|Participant Flow|Nilotinib 36-month Treatment|Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase
11128288|NCT01743989|FG002|Participant Flow|Not Randomized|Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized.
11128289|NCT01743989|OG000|Outcome|Nilotinib 24-month Treatment|Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase
11128290|NCT01743989|OG001|Outcome|Nilotinib 36-month Treatment|Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase
10848982|NCT00293202|OG000|Outcome|Etanercept|"Active comparator: Etanercept 25 mg injection twice a week~Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week for a total of 52 weeks"
11128291|NCT01743989|OG002|Outcome|Not Randomized|Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized.
11128292|NCT01743989|OG000|Outcome|Nilotinib 36-month Treatment|Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase
11128293|NCT01743989|OG001|Outcome|Nilotinib 36-month Treatment Arm|Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase
11128294|NCT01743989|EG000|Reported Event|Nilotinib 24-month Treatment|Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase
11128295|NCT01743989|EG001|Reported Event|Nilotinib 36-month Treatment|Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase
11128296|NCT01743989|EG002|Reported Event|Not Randomized|Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized.
11128297|NCT01743989|EG003|Reported Event|Total|Total
11128298|NCT01744197|BG000|Baseline|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
11008338|NCT01096446|BG002|Baseline|Total|Total of all reporting groups
11128299|NCT01744197|BG001|Baseline|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
11128300|NCT01744197|BG002|Baseline|Total|Total of all reporting groups
11128301|NCT01744197|FG000|Participant Flow|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
11128302|NCT01744197|FG001|Participant Flow|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
11128303|NCT01744197|OG000|Outcome|Synera|Treated with Synera.
11128304|NCT01744197|OG001|Outcome|Placebo|Treated with Placebo.
11128305|NCT01744197|EG000|Reported Event|Synera|Treated with Synera.
11128306|NCT01744197|EG001|Reported Event|Placebo|Treated with Placebo
11128307|NCT01744340|BG000|Baseline|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
11128308|NCT01744340|BG001|Baseline|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
11128309|NCT01744340|BG002|Baseline|Total|Total of all reporting groups
11128310|NCT01744340|FG000|Participant Flow|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
11128311|NCT01744340|FG001|Participant Flow|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
11128312|NCT01744340|OG000|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
11128313|NCT01744340|OG001|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
11128314|NCT01744340|EG000|Reported Event|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
11128315|NCT01744340|EG001|Reported Event|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
11128316|NCT01744353|BG000|Baseline|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
11128317|NCT01744353|BG001|Baseline|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
11128318|NCT01744353|BG002|Baseline|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
11128319|NCT01744353|BG003|Baseline|Total|Total of all reporting groups
11128320|NCT01744353|FG000|Participant Flow|Experimental: Dose Level 1|Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
11128321|NCT01744353|FG001|Participant Flow|Experimental: Dose Level 2/ MTD|Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
11128322|NCT01744353|FG002|Participant Flow|Experimental: Dose Level 3|Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
11128323|NCT01744353|OG000|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
11128324|NCT01744353|OG001|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
11128325|NCT01744353|OG002|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
11128326|NCT01744353|EG000|Reported Event|FOLFOX- A|"FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.~FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un"
11128327|NCT01744392|BG000|Baseline|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
11128328|NCT01744392|FG000|Participant Flow|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
11128329|NCT01744392|OG000|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
11128330|NCT01744392|OG000|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
11128331|NCT01744392|EG000|Reported Event|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
11128332|NCT01744483|BG000|Baseline|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
11128333|NCT01744483|BG001|Baseline|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
11128334|NCT01744483|BG002|Baseline|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
11128335|NCT01744483|BG003|Baseline|Total|Total of all reporting groups
11128336|NCT01744483|FG000|Participant Flow|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
11128337|NCT01744483|FG001|Participant Flow|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
11128338|NCT01744483|FG002|Participant Flow|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
11128339|NCT01744483|OG000|Outcome|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
11128340|NCT01744483|OG001|Outcome|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
11128341|NCT01744483|OG002|Outcome|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
11128342|NCT01744483|EG000|Reported Event|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
11128343|NCT01744483|EG001|Reported Event|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
11128344|NCT01744483|EG002|Reported Event|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
11128345|NCT01744496|BG000|Baseline|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
11128346|NCT01744496|BG001|Baseline|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
11128347|NCT01744496|BG002|Baseline|Total|Total of all reporting groups
11128348|NCT01744496|FG000|Participant Flow|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
11128349|NCT01744496|FG001|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
11128350|NCT01744496|OG000|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
11226837|NCT02378402|EG001|Reported Event|Stable HF Group|"Patients with acute HF episode with hospitalization treatment within 12 months, LVEF>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11128351|NCT01744496|OG001|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
11128352|NCT01744496|EG000|Reported Event|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
11128353|NCT01744496|EG001|Reported Event|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
11128354|NCT01744574|BG000|Baseline|Placebo-Males|Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128355|NCT01744574|BG001|Baseline|Progesterone-Males|Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128356|NCT01744574|BG002|Baseline|Placebo-Females|Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128357|NCT01744574|BG003|Baseline|Progesterone-Females|Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128358|NCT01744574|BG004|Baseline|Total|Total of all reporting groups
11128359|NCT01744574|FG000|Participant Flow|Placebo-Males|Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128360|NCT01744574|FG001|Participant Flow|Progesterone-Males|Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128361|NCT01744574|FG002|Participant Flow|Placebo-Females|Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128362|NCT01744574|FG003|Participant Flow|Progesterone-Females|Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128363|NCT01744574|OG000|Outcome|Placebo-Males|Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128364|NCT01744574|OG001|Outcome|Progesterone-Males|Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128365|NCT01744574|OG002|Outcome|Placebo-Females|Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128366|NCT01744574|OG003|Outcome|Progesterone-Females|Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128367|NCT01744574|EG000|Reported Event|Placebo-Males|Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128368|NCT01744574|EG001|Reported Event|Progesterone-Males|Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128369|NCT01744574|EG002|Reported Event|Placebo-Females|Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128370|NCT01744574|EG003|Reported Event|Progesterone-Females|Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
11128371|NCT01744665|BG000|Baseline|Overall|Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
11128372|NCT01744665|FG000|Participant Flow|Nilotinib|All patients enrolled in trial
11128373|NCT01744665|OG000|Outcome|Treatment Free Remission|Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
11128374|NCT01744665|OG000|Outcome|No Problems|No problems
11128375|NCT01744665|OG001|Outcome|Some Problems|Some problems
11128376|NCT01744665|OG002|Outcome|Extreme Problems|Extreme problems
11128377|NCT01744665|EG000|Reported Event|Nilotinib|Nilotinib
11128378|NCT01744691|BG000|Baseline|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
11128379|NCT01744691|FG000|Participant Flow|Ibrutinib|"All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.~Ibrutinib: All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily."
11128380|NCT01744691|OG000|Outcome|Ibrutinib|"All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.~ibrutinib: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily."
11128381|NCT01744691|OG000|Outcome|PCI-32765|"All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
11128382|NCT01744691|EG000|Reported Event|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
11128383|NCT01744704|BG000|Baseline|rhNGF 0.5 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 0.5 µg/mL Sentinel: one drop administration"
11128384|NCT01744704|BG001|Baseline|rhNGF 5 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 5 µg/mL Sentinel"
11128385|NCT01744704|BG002|Baseline|rhNGF 20 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 20 µg/mL Sentinel"
11128386|NCT01744704|BG003|Baseline|rhNGF 20 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 20 µg/mL Part A"
11128387|NCT01744704|BG004|Baseline|rhNGF 60 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 60 µg/mL Part A"
11128388|NCT01744704|BG005|Baseline|rhNGF 180 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 180 µg/mL Part A"
11128389|NCT01744704|BG006|Baseline|Placebo Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~Placebo Part A"
11128390|NCT01744704|BG007|Baseline|rhNGF 20 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject~rhNGF 20 µg/mL Part B"
11128391|NCT01744704|BG008|Baseline|rhNGF 60 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects~rhNGF 60 µg/mL Part B"
11128392|NCT01744704|BG009|Baseline|rhNGF 180 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects~rhNGF 180 µg/mL Part B"
11128393|NCT01744704|BG010|Baseline|Placebo Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects~Placebo Part B"
11128394|NCT01744704|BG011|Baseline|Total|Total of all reporting groups
11128395|NCT01744704|FG000|Participant Flow|rhNGF 0.5 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 0.5 µg/mL Sentinel: one drop administration"
11128396|NCT01744704|FG001|Participant Flow|rhNGF 5 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 5 µg/mL Sentinel"
11128397|NCT01744704|FG002|Participant Flow|rhNGF 20 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 20 µg/mL Sentinel"
11128398|NCT01744704|FG003|Participant Flow|rhNGF 60 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 60 µg/mL Part A"
11128399|NCT01744704|FG004|Participant Flow|rhNGF 20 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 20 µg/mL Part A"
11128400|NCT01744704|FG005|Participant Flow|rhNGF 180 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 180 µg/mL Part A"
11128401|NCT01744704|FG006|Participant Flow|Placebo Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~Placebo Part A"
11128402|NCT01744704|FG007|Participant Flow|rhNGF 20 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject~rhNGF 20 µg/mL Part B"
11128403|NCT01744704|FG008|Participant Flow|rhNGF 20 µg/mL Part B Cohort 0M|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 3 subjects~rhNGF 20 µg/mL Part B cohort 0M"
11128404|NCT01744704|FG009|Participant Flow|rhNGF 60 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects~rhNGF 60 µg/mL Part B"
11128405|NCT01744704|FG010|Participant Flow|rhNGF 180 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects~rhNGF 180 µg/mL Part B"
11128406|NCT01744704|FG011|Participant Flow|Placebo Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects~Placebo Part B"
11128407|NCT01744704|OG000|Outcome|rhNGF 0.5 µg/mL Sentinel|1 x 35 µL drop 3 subjects rhNGF 0.5 µg/mL Sentinel: one drop administration
11128408|NCT01744704|OG001|Outcome|rhNGF 5 µg/mL Sentinel|1 x 35 µL drop 3 subjects rhNGF 5 µg/mL Sentinel
11128409|NCT01744704|OG002|Outcome|rhNGF 20 µg/mL Sentinel|1 x 35 µL drop 3 subjects rhNGF 20 µg/mL Sentinel
11128410|NCT01744704|OG003|Outcome|rhNGF 20 µg/mL Part A|3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A
11128411|NCT01744704|OG004|Outcome|rhNGF 60 µg/mL Part A|3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
11128412|NCT01744704|OG005|Outcome|rhNGF 180 µg/mL Part A|3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 180 µg/mL Part A
11128413|NCT01744704|OG006|Outcome|Placebo Part A|3 x 35 µL drops applied at 4 h intervals 6 subjects Placebo Part A
11128414|NCT01744704|OG007|Outcome|rhNGF 20 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject~rhNGF 20 µg/mL Part B"
11128415|NCT01744704|OG008|Outcome|rhNGF 60 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects~rhNGF 60 µg/mL Part B"
11128416|NCT01744704|OG009|Outcome|rhNGF 180 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects~rhNGF 180 µg/mL Part B"
11128417|NCT01744704|OG010|Outcome|Placebo Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects~Placebo Part B"
11128418|NCT01744704|OG004|Outcome|hNGF 60 µg/mL Part A|3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
11128419|NCT01744704|OG003|Outcome|rhNGF 60 µg/mL Part A|3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
11128420|NCT01744704|OG004|Outcome|rhNGF 20 µg/mL Part A|3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A
11128421|NCT01744704|EG000|Reported Event|rhNGF 0.5 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 0.5 µg/mL Sentinel: one drop administration"
11128422|NCT01744704|EG001|Reported Event|rhNGF 5 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 5 µg/mL Sentinel"
11128423|NCT01744704|EG002|Reported Event|rhNGF 20 µg/mL Sentinel|"1 x 35 µL drop 3 subjects~rhNGF 20 µg/mL Sentinel"
11128424|NCT01744704|EG003|Reported Event|rhNGF 20 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 20 µg/mL Part A"
11128425|NCT01744704|EG004|Reported Event|rhNGF 60 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 60 µg/mL Part A"
11128426|NCT01744704|EG005|Reported Event|rhNGF 180 µg/mL Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~rhNGF 180 µg/mL Part A"
11128427|NCT01744704|EG006|Reported Event|Placebo Part A|"3 x 35 µL drops applied at 4 h intervals 6 subjects~Placebo Part A"
11128428|NCT01744704|EG007|Reported Event|rhNGF 20 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 12 subject~rhNGF 20 µg/mL Part B"
11128429|NCT01744704|EG008|Reported Event|rhNGF 60 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects~rhNGF 60 µg/mL Part B"
11128430|NCT01744704|EG009|Reported Event|rhNGF 180 µg/mL Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects~rhNGF 180 µg/mL Part B"
11128431|NCT01744704|EG010|Reported Event|Placebo Part B|"3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects~Placebo Part B"
11128432|NCT01744730|BG000|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
11128433|NCT01744730|BG001|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
11128434|NCT01744730|BG002|Baseline|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
11128435|NCT01744730|BG003|Baseline|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
11128436|NCT01744730|BG004|Baseline|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
11128437|NCT01744730|BG005|Baseline|Total|Total of all reporting groups
11128438|NCT01744730|FG000|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
11128439|NCT01744730|FG001|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
11128440|NCT01744730|FG002|Participant Flow|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
11128441|NCT01744730|FG003|Participant Flow|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
11128442|NCT01744730|FG004|Participant Flow|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration.
11128443|NCT01744730|OG000|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
11128444|NCT01744730|OG001|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
11128445|NCT01744730|OG002|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
11008339|NCT01096446|FG000|Participant Flow|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
11008340|NCT01096446|FG001|Participant Flow|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
11008341|NCT01096446|OG000|Outcome|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
11008342|NCT01096446|OG001|Outcome|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
11008343|NCT01096446|EG000|Reported Event|Serum Triglycerides|Serum triglycerides <201 mg/dl in both arms were considered to be normal. If serum triglycerides in either arm was above 201 mg/dl than the Intralipids was decreased based on the algorithm for adjusting IVFE when hypertriglyceridemia occured.
11008344|NCT01096550|BG000|Baseline|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
11008345|NCT01096550|BG001|Baseline|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
11008346|NCT01096550|BG002|Baseline|Total|Total of all reporting groups
11008347|NCT01096550|FG000|Participant Flow|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
11008348|NCT01096550|FG001|Participant Flow|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
11008349|NCT01096550|OG000|Outcome|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
11008350|NCT01096550|OG001|Outcome|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
11008351|NCT01096550|EG000|Reported Event|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
11008352|NCT01096550|EG001|Reported Event|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
11065988|NCT01390584|OG000|Outcome|ABVD + INRT|"Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.~PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.~ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.~Doxorubicin: IV~Bleomycin: IV~Vinblastine: IV~PET: fludeoxyglucose F 18 Imaging exam~INRT: selective external radiation therapy~Dacarbazine: IV"
11065989|NCT01390584|OG001|Outcome|ABVD + BEACOPP + INRT|"Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.~PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.~BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.~Doxorubicin: IV~Bleomycin: IV~Vinblastine: IV~PET: fludeoxyglucose F 18 Imaging exam~INRT: selective external radiation therapy~Dacarbazine: IV~Etoposide: IV~Cyclophosphamide: May be given orally, IV push, or by IV infusion~Vincristine: IV~Procarbazine: PO~Prednisone: PO"
11065990|NCT01390584|OG000|Outcome|Step 1: Induction Tx|Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
11067008|NCT01394718|BG001|Baseline|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
11067009|NCT01394718|BG002|Baseline|Total|Total of all reporting groups
11067010|NCT01394718|FG000|Participant Flow|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
11128446|NCT01744730|OG003|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
11128447|NCT01744730|OG004|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
11128448|NCT01744730|OG005|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
11128449|NCT01744730|EG000|Reported Event|Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
11128450|NCT01744730|EG001|Reported Event|Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 2 to 11 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
11128451|NCT01744730|EG002|Reported Event|Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
11128452|NCT01744730|EG003|Reported Event|Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 12 to 17 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
11128453|NCT01744730|EG004|Reported Event|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
11128454|NCT01744782|BG000|Baseline|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
11128455|NCT01744782|FG000|Participant Flow|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
11128456|NCT01744782|OG000|Outcome|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
11128457|NCT01744782|EG000|Reported Event|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
11128458|NCT01744821|BG000|Baseline|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
11128459|NCT01744821|BG001|Baseline|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
11128460|NCT01744821|BG002|Baseline|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
11128461|NCT01744821|BG003|Baseline|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
11128462|NCT01744821|BG004|Baseline|Total|Total of all reporting groups
11128463|NCT01744821|FG000|Participant Flow|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
11128464|NCT01744821|FG001|Participant Flow|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
11128465|NCT01744821|FG002|Participant Flow|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
11128466|NCT01744821|FG003|Participant Flow|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
11128467|NCT01744821|OG000|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
11128468|NCT01744821|OG001|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
11128469|NCT01744821|OG002|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
11128470|NCT01744821|OG003|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
11128471|NCT01744821|EG000|Reported Event|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
11128472|NCT01744821|EG001|Reported Event|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
11128473|NCT01744821|EG002|Reported Event|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
11008353|NCT01096589|BG000|Baseline|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008354|NCT01096589|BG001|Baseline|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008355|NCT01096589|BG002|Baseline|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008356|NCT01096589|BG003|Baseline|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
11008357|NCT01096589|BG004|Baseline|Total|Total of all reporting groups
11008358|NCT01096589|FG000|Participant Flow|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008359|NCT01096589|FG001|Participant Flow|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008360|NCT01096589|FG002|Participant Flow|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008361|NCT01096589|FG003|Participant Flow|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
11008362|NCT01096589|OG000|Outcome|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008363|NCT01096589|OG001|Outcome|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008364|NCT01096589|OG002|Outcome|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008365|NCT01096589|OG003|Outcome|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
11008366|NCT01096589|OG000|Outcome|Arm 1 - 3M Coban 2|"3M Coban 2 - 2 apps/wk~3M Coban 2 (Compression System): Nonwoven cohesive backing and foam."
11008367|NCT01096589|OG001|Outcome|Arm 2 - 3M Coban 2|"3M Coban 2 - 3 apps/wk~3M Coban 2 (Compression System): Nonwoven cohesive backing and foam."
11008368|NCT01096589|OG002|Outcome|Arm 3 - 3M Coban 2|"Arm 3 - 3M Coban 2 - 5 apps/wk~3M Coban 2 (Compression System): Nonwoven cohesive backing and foam."
11008369|NCT01096589|OG003|Outcome|Arm 4 - Comprilan|"Comprilan short-stretch bandage 5 apps/wk~Comprilan: Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
11008370|NCT01096589|EG000|Reported Event|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008371|NCT01096589|EG001|Reported Event|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008372|NCT01096589|EG002|Reported Event|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
11008373|NCT01096589|EG003|Reported Event|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
11008374|NCT01096667|BG000|Baseline|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
11008375|NCT01096667|BG001|Baseline|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
11008376|NCT01096667|BG002|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
11008377|NCT01096667|BG003|Baseline|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
11008378|NCT01096667|BG004|Baseline|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
11008379|NCT01096667|BG005|Baseline|Total|Total of all reporting groups
11008380|NCT01096667|FG000|Participant Flow|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to hydrochlorothiazide (HCTZ), once daily for 28 days.
11008381|NCT01096667|FG001|Participant Flow|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
11008382|NCT01096667|FG002|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
11008383|NCT01096667|FG003|Participant Flow|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
11008384|NCT01096667|FG004|Participant Flow|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
11008385|NCT01096667|OG000|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
11008386|NCT01096667|OG001|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
11008387|NCT01096667|OG002|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
11008388|NCT01096667|OG003|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
11008389|NCT01096667|OG004|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
11008390|NCT01096667|EG000|Reported Event|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
11008391|NCT01096667|EG001|Reported Event|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
11008392|NCT01096667|EG002|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
11008393|NCT01096667|EG003|Reported Event|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
11008394|NCT01096667|EG004|Reported Event|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
11008395|NCT01096667|EG005|Reported Event|Pre-randomization|Blinded placebo was administered for at least 21 days prior to randomization.
11008396|NCT01096680|BG000|Baseline|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008397|NCT01096680|BG001|Baseline|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008398|NCT01096680|BG002|Baseline|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008399|NCT01096680|BG003|Baseline|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008400|NCT01096680|BG004|Baseline|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008401|NCT01096680|BG005|Baseline|Total|Total of all reporting groups
11008402|NCT01096680|FG000|Participant Flow|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008403|NCT01096680|FG001|Participant Flow|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008404|NCT01096680|FG002|Participant Flow|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008405|NCT01096680|FG003|Participant Flow|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11128474|NCT01744821|EG003|Reported Event|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
11008406|NCT01096680|FG004|Participant Flow|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008407|NCT01096680|OG000|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008408|NCT01096680|OG001|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008409|NCT01096680|OG002|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008410|NCT01096680|OG003|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008411|NCT01096680|OG004|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008412|NCT01096680|EG000|Reported Event|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008413|NCT01096680|EG001|Reported Event|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008414|NCT01096680|EG002|Reported Event|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008415|NCT01096680|EG003|Reported Event|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008416|NCT01096680|EG004|Reported Event|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
11008417|NCT01096771|BG000|Baseline|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
11008418|NCT01096771|BG001|Baseline|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
11008419|NCT01096771|BG002|Baseline|Total|Total of all reporting groups
11008420|NCT01096771|FG000|Participant Flow|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
11008421|NCT01096771|FG001|Participant Flow|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
11008422|NCT01096771|OG000|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
11008423|NCT01096771|OG001|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
11008424|NCT01096771|EG000|Reported Event|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
11008425|NCT01096771|EG001|Reported Event|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
11008426|NCT01096784|BG000|Baseline|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
11008427|NCT01096784|BG001|Baseline|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
11008428|NCT01096784|BG002|Baseline|Total|Total of all reporting groups
11008429|NCT01096784|FG000|Participant Flow|rhIGF-1/rhIGFBP-3|Participants received insulin-like growth factor (rhIGF-I)/insulin-like growth factor binding protein-3 (rhIGFBP-3) 250 microgram per kilogram (mcg/kg) for 24 hours through continuous intravenous (IV) infusion from Day 0 up to 29 weeks 6 days of post-menstrual age (PMA).
11008430|NCT01096784|FG001|Participant Flow|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
11008431|NCT01096784|OG000|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
11008432|NCT01096784|OG001|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
11008433|NCT01096784|OG000|Outcome|rhIGF-I/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
11008434|NCT01096784|OG001|Outcome|Control|Participants in this control group do not received any treatment other than the standard care.
11128475|NCT01744860|BG000|Baseline|Melanoma Tumor Sample With BRAF V600 Mutation|"BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods and Cobas 4800 mutation test"
11128476|NCT01744860|FG000|Participant Flow|Melanoma Tumor Sample With BRAF V600 Mutation|"BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods and Cobas 4800 mutation test"
11128477|NCT01744860|OG000|Outcome|"INCa Molecular Genetics Laboratory in House Methods"|"BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods"
11128478|NCT01744860|OG001|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
11128479|NCT01744860|OG000|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
11128480|NCT01744860|OG000|Outcome|"INCa Molecular Genetics Laboratory In-house Methods"|"BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods."
11128481|NCT01744860|OG000|Outcome|"INCa Molecular Genetics Laboratory In-house Methods"|"BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods"
11128482|NCT01744860|OG000|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
11128483|NCT01744860|OG000|Outcome|Discordant Group|"This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa in House Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome."
11128484|NCT01744860|OG000|Outcome|Final Result- Discordant Samples|"This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa in House Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome."
11128485|NCT01744860|EG000|Reported Event|"INCa Molecular Genetics Laboratory in House Methods"|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods
11128486|NCT01744860|EG001|Reported Event|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
11149548|NCT01871506|FG000|Participant Flow|Standard Treatment (ST)|"Participants randomized to standard treatment will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.~(2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.~(3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects."
11149549|NCT01871506|FG001|Participant Flow|Intensive Treatment (IT)|"Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the ST arm. IT participants have the option to also receive:~Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).~Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication [varenicline, bupropion, or combination NRT (patch + lozenge)] at no cost to the participant.~Intensive Treatment (IT): The IT model includes all components of the ST as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication."
11149550|NCT01871506|OG000|Outcome|Standard Treatment (ST)|"Participants randomized to standard treatment (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.~(2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.~(3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects."
11149551|NCT01871506|OG001|Outcome|Intensive Treatment (IT)|"Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive:~Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).~Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication [varenicline, bupropion, or combination NRT (patch + lozenge)] at no cost to the participant.~Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication.~(1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions."
11149552|NCT01871506|OG000|Outcome|Standard Treatment (ST)|"Participants randomized to ST will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~Standard Care (SC): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.~(2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.~(3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects."
11008435|NCT01096784|EG000|Reported Event|rhIGF-I/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
11008436|NCT01096784|EG001|Reported Event|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
11008437|NCT01096810|BG000|Baseline|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
11008438|NCT01096810|FG000|Participant Flow|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
11008439|NCT01096810|OG000|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
11008440|NCT01096810|EG000|Reported Event|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
11008441|NCT01096823|BG000|Baseline|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
11008442|NCT01096823|BG001|Baseline|Waitlist Control|Standard of care waitlist control group
11008443|NCT01096823|BG002|Baseline|Total|Total of all reporting groups
11008444|NCT01096823|FG000|Participant Flow|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
11008445|NCT01096823|FG001|Participant Flow|Waitlist Control|Standard of care waitlist control group
11008446|NCT01096823|OG000|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
11008447|NCT01096823|OG001|Outcome|Waitlist Control|Standard of care waitlist control group
11008448|NCT01096823|EG000|Reported Event|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
11008449|NCT01096823|EG001|Reported Event|Waitlist Control|Standard of care waitlist control group
11008450|NCT01096849|BG000|Baseline|Plazomicin (10 mg/kg)|Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
11008451|NCT01096849|BG001|Baseline|Plazomicin (15 mg/kg)|Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
11008452|NCT01096849|BG002|Baseline|Levofloxacin|Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
11008453|NCT01096849|BG003|Baseline|Total|Total of all reporting groups
11008454|NCT01096849|FG000|Participant Flow|Plazomicin (10 mg/kg)|Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo.
11008455|NCT01096849|FG001|Participant Flow|Plazomicin (15 mg/kg)|Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
11008456|NCT01096849|FG002|Participant Flow|Levofloxacin|Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.
11008457|NCT01096849|OG000|Outcome|Plazomicin (10 mg/kg)|Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
11008458|NCT01096849|OG001|Outcome|Plazomicin (15 mg/kg)|Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
11008459|NCT01096849|OG002|Outcome|Levofloxacin|Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
11008460|NCT01096849|EG000|Reported Event|Plazomicin (10 mg/kg)|Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
11008461|NCT01096849|EG001|Reported Event|Plazomicin (15 mg/kg)|Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
11008462|NCT01096849|EG002|Reported Event|Levofloxacin|Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
11008463|NCT01096875|BG000|Baseline|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
11008464|NCT01096875|BG001|Baseline|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
11008465|NCT01096875|BG002|Baseline|Total|Total of all reporting groups
11008466|NCT01096875|FG000|Participant Flow|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
11008467|NCT01096875|FG001|Participant Flow|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
11008468|NCT01096875|OG000|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
11008469|NCT01096875|OG001|Outcome|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
11008470|NCT01096875|OG000|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
11008471|NCT01096875|OG001|Outcome|Placebo|"Atorvastatin like pill~Placebo: 1tb/day once daily for two weeks prior to surgery"
11008472|NCT01096875|EG000|Reported Event|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
11008473|NCT01096875|EG001|Reported Event|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
11008474|NCT01096992|BG000|Baseline|Phase 1 20 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008475|NCT01096992|BG001|Baseline|Phase 1 30 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008476|NCT01096992|BG002|Baseline|Phase 1 40 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11128487|NCT01744977|BG000|Baseline|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
11128488|NCT01744977|BG001|Baseline|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
11128489|NCT01744977|BG002|Baseline|Total|Total of all reporting groups
11128490|NCT01744977|FG000|Participant Flow|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA (Research Assistant) on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
11128491|NCT01744977|FG001|Participant Flow|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
11128492|NCT01744977|OG000|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
11128493|NCT01744977|OG001|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
11128494|NCT01744977|EG000|Reported Event|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
11128495|NCT01744977|EG001|Reported Event|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
11128496|NCT01745055|BG000|Baseline|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
11128497|NCT01745055|FG000|Participant Flow|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
11128498|NCT01745055|OG000|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
11128499|NCT01745055|OG001|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
11128500|NCT01745055|OG000|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
11128501|NCT01745055|OG000|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
11128502|NCT01745055|EG000|Reported Event|Methotrexate|Single oral dose of MTX on Day 1 (15-25 mg), as per local prescribing practice.
11128503|NCT01745055|EG001|Reported Event|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
11128504|NCT01745055|EG002|Reported Event|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
11128505|NCT01745094|BG000|Baseline|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128506|NCT01745094|BG001|Baseline|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
11128507|NCT01745094|BG002|Baseline|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128508|NCT01745094|BG003|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
11128509|NCT01745094|BG004|Baseline|Total|Total of all reporting groups
11128510|NCT01745094|FG000|Participant Flow|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128511|NCT01745094|FG001|Participant Flow|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
11128512|NCT01745094|FG002|Participant Flow|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128513|NCT01745094|FG003|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
11128514|NCT01745094|OG000|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128515|NCT01745094|OG001|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
11128516|NCT01745094|OG002|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128517|NCT01745094|OG003|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
11128518|NCT01745094|OG000|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Patients received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128519|NCT01745094|OG002|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Patients received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128520|NCT01745094|OG003|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|"Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg."
11128521|NCT01745094|EG000|Reported Event|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128522|NCT01745094|EG001|Reported Event|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
11128523|NCT01745094|EG002|Reported Event|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
11128524|NCT01745094|EG003|Reported Event|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
11128525|NCT01745120|BG000|Baseline|Non-β0/β0|Participants who had at least 1 mutation in the HBB gene that results in reduced but detectable expression of β-globin: β+ or βE (non-β0/β0 genotype) underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128526|NCT01745120|BG001|Baseline|β0/β0|Participants who were bi-allelic for mutations in the HBB gene that results in absence of expression of β-globin: β0 (β0/β0 genotype) underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128527|NCT01745120|BG002|Baseline|Total|Total of all reporting groups
11128528|NCT01745120|FG000|Participant Flow|Non-β0/β0|Participants who had at least 1 mutation in the HBB gene that results in reduced but detectable expression of beta(β)-globin: β+ or βE (non-β0/β0 genotype) underwent hematopoietic stem cell (HSC) mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of greater than or equal to (>=) 3.0 × 10^6 CD34+ cells per kilogram (cells/kg).
11128529|NCT01745120|FG001|Participant Flow|β0/β0|Participants who were bi-allelic for mutations in the HBB gene that results in absence of expression of β-globin: β0 (β0/β0 genotype) underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128530|NCT01745120|OG000|Outcome|Non-β0/β0|Participants who had at least 1 mutation in the HBB gene that results in reduced but detectable expression of β-globin: β+ or βE (non-β0/β0 genotype) underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128531|NCT01745120|OG001|Outcome|β0/β0|Participants who were bi-allelic for mutations in the HBB gene that results in absence of expression of β-globin: β0 (β0/β0 genotype) underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128532|NCT01745120|OG002|Outcome|Overall|Participants with a β0/β0 genotype or non-β0/β0 genotypes underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128533|NCT01745120|OG000|Outcome|Overall|Participants with a β0/β0 genotype or non-β0/β0 genotypes underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128534|NCT01745120|EG000|Reported Event|Non-β0/β0|Participants who had at least 1 mutation in the HBB gene that results in reduced but detectable expression of β-globin: β+ or βE (non-β0/β0 genotype) underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11008477|NCT01096992|BG003|Baseline|Phase 1 50 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008478|NCT01096992|BG004|Baseline|Phase 2|"Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab~Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008479|NCT01096992|BG005|Baseline|Total|Total of all reporting groups
11008480|NCT01096992|FG000|Participant Flow|Phase 1 20 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008481|NCT01096992|FG001|Participant Flow|Phase 1 30 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008482|NCT01096992|FG002|Participant Flow|Phase 1 40 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008483|NCT01096992|FG003|Participant Flow|Phase 1 50 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008484|NCT01096992|FG004|Participant Flow|Phase 2|"Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab~Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008485|NCT01096992|OG000|Outcome|Phase 1|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine)~Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1"
11008486|NCT01096992|OG000|Outcome|Phase 1 20 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008487|NCT01096992|OG001|Outcome|Phase 1 30 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008488|NCT01096992|OG002|Outcome|Phase 1 40 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008489|NCT01096992|OG003|Outcome|Phase 1 50 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008490|NCT01096992|OG004|Outcome|Phase 2|"Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab~Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008491|NCT01096992|EG000|Reported Event|Phase 1 20 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008492|NCT01096992|EG001|Reported Event|Phase 1 30 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008493|NCT01096992|EG002|Reported Event|Phase 1 40 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008494|NCT01096992|EG003|Reported Event|Phase 1 50 mg/m^2|"Bendamustine, Fludarabine + Rituximab~Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008495|NCT01096992|EG004|Reported Event|Phase 2|"Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab~Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine)~Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3~Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1"
11008496|NCT01097044|BG000|Baseline|Afamelanotide|Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total)
11008497|NCT01097044|BG001|Baseline|Placebo|Placebo: One placebo subcutaneous implant every 2 months for 6 months. (3 implants in total)
11008498|NCT01097044|BG002|Baseline|Total|Total of all reporting groups
11008499|NCT01097044|FG000|Participant Flow|Afamelanotide|Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total)
11008500|NCT01097044|FG001|Participant Flow|Placebo|Placebo: One placebo subcutaneous implant every 2 months for 6 months. (3 implants in total)
11008501|NCT01097044|OG000|Outcome|Afamelanotide|Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total)
11008502|NCT01097044|OG001|Outcome|Placebo|Placebo: One placebo subcutaneous implant every 2 months for 6 months. (3 implants in total)
11008503|NCT01097044|OG000|Outcome|Afamelanotide|"Dose: 16 mg implant; release of 16 mg over 7 to 10 days Mode of administration: Subcutaneous implantation Frequency: Every 60 days (on Days 0, 60 and 120)~Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total)"
11008504|NCT01097044|OG001|Outcome|Placebo|"Dose: 16 mg implant; Mode of administration: Subcutaneous implantation Frequency: Every 60 days (on Days 0, 60 and 120)~Placebo: One placebo subcutaneous implant every 2 months for 6 months. (3 implants in total)"
11008505|NCT01097044|EG000|Reported Event|Afamelanotide|Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total)
11008506|NCT01097044|EG001|Reported Event|Placebo|Placebo: One placebo subcutaneous implant every 2 months for 6 months. (3 implants in total)
11008507|NCT01097057|BG000|Baseline|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
11008508|NCT01097057|FG000|Participant Flow|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
11008509|NCT01097057|OG000|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
11008510|NCT01097057|EG000|Reported Event|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
11008511|NCT01097304|BG000|Baseline|Treatment (Ursodiol)|"Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11008512|NCT01097304|FG000|Participant Flow|Treatment (Ursodiol)|"Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11008513|NCT01097304|OG000|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11008514|NCT01097304|OG000|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11008515|NCT01097304|EG000|Reported Event|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11008516|NCT01097330|BG000|Baseline|Ablation|"Catheter based radiofrequency ablation for ischemic ventricular tachycardia~Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization"
11008517|NCT01097330|BG001|Baseline|Amiodarone|"amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.~Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study"
11008518|NCT01097330|BG002|Baseline|Total|Total of all reporting groups
11008519|NCT01097330|FG000|Participant Flow|Ablation|"Catheter based radiofrequency ablation for ischemic ventricular tachycardia~Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization"
11008520|NCT01097330|FG001|Participant Flow|Amiodarone|"amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.~Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study"
11008521|NCT01097330|OG000|Outcome|Ablation|"Catheter based radiofrequency ablation for ischemic ventricular tachycardia~Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization"
11128535|NCT01745120|EG001|Reported Event|β0/β0|Participants who were bi-allelic for mutations in the HBB gene that results in absence of expression of β-globin: β0 (β0/β0 genotype) underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128536|NCT01745120|EG002|Reported Event|Overall|Participants with a β0/β0 genotype or non-β0/β0 genotypes underwent HSC mobilization with G-CSF and plerixafor, followed by myeloablative conditioning and infusion with LentiGlobin BB305 Drug Product at a dose of >= 3.0 × 10^6 CD34+ cells/kg.
11128537|NCT01745133|BG000|Baseline|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
11128538|NCT01745133|BG001|Baseline|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
11128539|NCT01745133|BG002|Baseline|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
11128540|NCT01745133|BG003|Baseline|Total|Total of all reporting groups
11128541|NCT01745133|FG000|Participant Flow|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
11128542|NCT01745133|FG001|Participant Flow|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
11128543|NCT01745133|FG002|Participant Flow|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
11128544|NCT01745133|OG000|Outcome|Vehicle 68%|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
11128545|NCT01745133|OG001|Outcome|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
11128546|NCT01745133|OG002|Outcome|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
11128547|NCT01745133|EG000|Reported Event|Vehicle|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
11128548|NCT01745133|EG001|Reported Event|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
11128549|NCT01745133|EG002|Reported Event|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
11128550|NCT01745146|BG000|Baseline|Personal Readjustment and Education (PRE)|Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
11128551|NCT01745146|BG001|Baseline|Anger Self-Management Training (ASMT)|Participants provided with education emphasizing the teaching of behavioral skills (self-monitoring, problem-solving) in addition to focused education about anger and its links to traumatic brain injury (TBI).
11128552|NCT01745146|BG002|Baseline|Total|Total of all reporting groups
11128553|NCT01745146|FG000|Participant Flow|Personal Readjustment and Education (PRE)|Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
11128554|NCT01745146|FG001|Participant Flow|Anger Self-Management Training (ASMT)|Participants provided with education emphasizing the teaching of behavioral skills (self-monitoring, problem-solving) in addition to focused education about anger and its links to traumatic brain injury (TBI).
11128555|NCT01745146|OG000|Outcome|Personal Readjustment and Education (PRE)|Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
11128556|NCT01745146|OG001|Outcome|Anger Self-Management Training (ASMT)|Participants provided with education emphasizing the teaching of behavioral skills (self-monitoring, problem-solving) in addition to focused education about anger and its links to traumatic brain injury (TBI).
11128557|NCT01745146|OG002|Outcome|Difference|The difference in treatment response rates between the ASMT group and the PRE group.
11128558|NCT01745146|EG000|Reported Event|Personal Readjustment and Education (PRE)|Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
11128559|NCT01745146|EG001|Reported Event|Anger Self-Management Training (ASMT)|Participants provided with education emphasizing the teaching of behavioral skills (self-monitoring, problem-solving) in addition to focused education about anger and its links to traumatic brain injury (TBI).
11128560|NCT01745211|BG000|Baseline|755nm Alexandrite Laser|"755nm Alexandrite laser (standard handpiece)~755nm Alexandrite Laser: 755nm Alexandrite laser with modified and standard handpiece"
11128561|NCT01745211|FG000|Participant Flow|755nm Alexandrite Laser|755nm Alexandrite laser with array handpiece
11128562|NCT01745211|OG000|Outcome|755nm Alexandrite Laser With Array Handpiece|755nm Alexandrite Laser: 755nm Alexandrite laser with array handpiece
11128563|NCT01745211|EG000|Reported Event|755nm Alexandrite Laser|755nm Alexandrite laser 755nm Alexandrite Laser: 755nm Alexandrite laser with array handpiece
11128564|NCT01745367|BG000|Baseline|Placebo in Combination With Paclitaxel|Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
11128565|NCT01745367|BG001|Baseline|Tivozanib Hydrochloride in Combination With Paclitaxel|Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
11128566|NCT01745367|BG002|Baseline|Total|Total of all reporting groups
11128567|NCT01745367|FG000|Participant Flow|Placebo in Combination With Paclitaxel|Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
11128568|NCT01745367|FG001|Participant Flow|Tivozanib Hydrochloride in Combination With Paclitaxel|Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
11128569|NCT01745367|OG000|Outcome|Tivozanib Hydrochloride in Combination With Paclitaxel|1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
11128570|NCT01745367|OG001|Outcome|Placebo in Combination With Paclitaxel|Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
11128571|NCT01745367|EG000|Reported Event|Placebo in Combination With Paclitaxel|Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
11128572|NCT01745367|EG001|Reported Event|Tivozanib Hydrochloride in Combination With Paclitaxel|Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
11128573|NCT01745380|BG000|Baseline|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
11128574|NCT01745380|BG001|Baseline|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
11128575|NCT01745380|BG002|Baseline|Total|Total of all reporting groups
11128576|NCT01745380|FG000|Participant Flow|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
11128577|NCT01745380|FG001|Participant Flow|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
11128578|NCT01745380|OG000|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
11128579|NCT01745380|OG001|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
11128580|NCT01745380|EG000|Reported Event|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
11128581|NCT01745380|EG001|Reported Event|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
11128582|NCT01745393|BG000|Baseline|Clinic Quality Improvement + Behavioral Counseling|"This multilevel intervention includes advice and a referral from a pediatrician, behavioral counseling by study staff, and community systems navigation, all designed to reduce pediatric secondhand smoke exposure. Over the course of 12 weeks participants receive a home visit designed to orient them to the program and trained health counselors provide multiple individualized phone counseling sessions designed to build coping skills, urge management skills, and self-efficacy. Counseling also includes assistance with goal setting and navigation of local resources.~Clinic Quality Improvement + Behavioral Counseling"
11128583|NCT01745393|BG001|Baseline|Clinic Quality Improvement + Attention Control|"The attention control intervention parallels the format of the experimental group but focuses on family nutrition information. The intervention includes a home visit to orient the participant to the program and multiple phone counseling sessions conducted by a trained health counselor.~Clinic Quality Improvement + Attention Control"
11128584|NCT01745393|BG002|Baseline|Total|Total of all reporting groups
11128585|NCT01745393|FG000|Participant Flow|Clinic Quality Improvement + Behavioral Counseling|"This multilevel intervention includes advice and a referral from a pediatrician, behavioral counseling by study staff, and community systems navigation, all designed to reduce pediatric secondhand smoke exposure. Over the course of 12 weeks participants receive a home visit designed to orient them to the program and trained health counselors provide multiple individualized phone counseling sessions designed to build coping skills, urge management skills, and self-efficacy. Counseling also includes assistance with goal setting and navigation of local resources.~Clinic Quality Improvement + Behavioral Counseling"
11008522|NCT01097330|OG001|Outcome|Amiodarone|"amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.~Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study"
11008523|NCT01097330|EG000|Reported Event|Ablation|"Catheter based radiofrequency ablation for ischemic ventricular tachycardia~Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization"
11008524|NCT01097330|EG001|Reported Event|Amiodarone|"amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.~Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study"
11008525|NCT01097343|BG000|Baseline|Cross-over Study|All Study Participants
11008526|NCT01097343|FG000|Participant Flow|75 mg First 30 Days, Followed by 150 mg|25 patients with the target allele were identified, and receive 75mg followed by 150 mg clopidogrel daily for two separate dosing periods of 30 days
11008527|NCT01097343|FG001|Participant Flow|150 mg First 30 Days, Followed by 75 mg|25 patients with the target allele were identified, and received 150 mg clopidogrel followed by 75 mg clopidogrel for two daily for separate dosing periods of 30 days
11008528|NCT01097343|OG000|Outcome|Cross-over Study- 75 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
11008529|NCT01097343|OG001|Outcome|Cross-over Study - 150 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
11008530|NCT01097343|EG000|Reported Event|75 mg Followed by 150 mg|Cross-over study
11008531|NCT01097343|EG001|Reported Event|150 mg Followed by 75 mg|Cross-over study
11008532|NCT01097395|BG000|Baseline|Standard Weight-Based Ribavirin Dosing|"1000 mg daily in patients weighing <75 kg and 1200 mg daily in patients weighing ≥ 75 kg~ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12"
11008533|NCT01097395|BG001|Baseline|Concentration-Controlled Ribavirin Dosing|"Dose adjusted based on first dose AUC0-12~ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12"
11008534|NCT01097395|BG002|Baseline|Total|Total of all reporting groups
11008535|NCT01097395|FG000|Participant Flow|Standard Weight-Based Ribavirin Dosing|"1000 mg daily in patients weighing <75 kg and 1200 mg daily in patients weighing ≥ 75 kg~ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12"
11008536|NCT01097395|FG001|Participant Flow|Concentration-Controlled Ribavirin Dosing|"Dose adjusted based on first dose AUC0-12~ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12"
11008537|NCT01097395|OG000|Outcome|Standard Weight-Based Ribavirin Dosing|"1000 mg daily in patients weighing <75 kg and 1200 mg daily in patients weighing ≥ 75 kg~ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12"
11008538|NCT01097395|OG001|Outcome|Concentration-Controlled Ribavirin Dosing|"Dose adjusted based on first dose AUC0-12~ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12"
11008539|NCT01097395|EG000|Reported Event|Standard Weight-Based Ribavirin Dosing|"1000 mg daily in patients weighing <75 kg and 1200 mg daily in patients weighing ≥ 75 kg~ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12"
11342015|NCT03694925|EG000|Reported Event|Primary Total Knee Arthroplasty|"There will be n=30 primary TKA patients included in the study, to provide a baseline level for calprotectin.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11008540|NCT01097395|EG001|Reported Event|Concentration-Controlled Ribavirin Dosing|"Dose adjusted based on first dose AUC0-12~ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12"
11008541|NCT01097421|BG000|Baseline|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
11008542|NCT01097421|FG000|Participant Flow|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
11008543|NCT01097421|OG000|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
11008544|NCT01097421|EG000|Reported Event|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
11008545|NCT01097460|BG000|Baseline|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
11008546|NCT01097460|FG000|Participant Flow|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
11008547|NCT01097460|OG000|Outcome|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
11008548|NCT01097460|EG000|Reported Event|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
11008549|NCT01097577|BG000|Baseline|Pregabalin|pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
11008550|NCT01097577|BG001|Baseline|Lactose Capsule|Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
11008551|NCT01097577|BG002|Baseline|Total|Total of all reporting groups
11008552|NCT01097577|FG000|Participant Flow|Pregabalin|pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
11128586|NCT01745393|FG001|Participant Flow|Clinic Quality Improvement + Attention Control|"The attention control intervention parallels the format of the experimental group but focuses on family nutrition information. The intervention includes a home visit to orient the participant to the program and multiple phone counseling sessions conducted by a trained health counselor.~Clinic Quality Improvement + Attention Control"
11128587|NCT01745393|OG000|Outcome|Clinic Quality Improvement + Behavioral Counseling|"This multilevel intervention includes advice and a referral from a pediatrician, behavioral counseling by study staff, and community systems navigation, all designed to reduce pediatric secondhand smoke exposure. Over the course of 12 weeks participants receive a home visit designed to orient them to the program and trained health counselors provide multiple individualized phone counseling sessions designed to build coping skills, urge management skills, and self-efficacy. Counseling also includes assistance with goal setting and navigation of local resources.~Clinic Quality Improvement + Behavioral Counseling"
11128588|NCT01745393|OG001|Outcome|Clinic Quality Improvement + Attention Control|"The attention control intervention parallels the format of the experimental group but focuses on family nutrition information. The intervention includes a home visit to orient the participant to the program and multiple phone counseling sessions conducted by a trained health counselor.~Clinic Quality Improvement + Attention Control"
11128589|NCT01745393|EG000|Reported Event|Clinic Quality Improvement + Behavioral Counseling|"This multilevel intervention includes advice and a referral from a pediatrician, behavioral counseling by study staff, and community systems navigation, all designed to reduce pediatric secondhand smoke exposure. Over the course of 12 weeks participants receive a home visit designed to orient them to the program and trained health counselors provide multiple individualized phone counseling sessions designed to build coping skills, urge management skills, and self-efficacy. Counseling also includes assistance with goal setting and navigation of local resources.~Clinic Quality Improvement + Behavioral Counseling"
11128590|NCT01745393|EG001|Reported Event|Clinic Quality Improvement + Attention Control|"The attention control intervention parallels the format of the experimental group but focuses on family nutrition information. The intervention includes a home visit to orient the participant to the program and multiple phone counseling sessions conducted by a trained health counselor.~Clinic Quality Improvement + Attention Control"
11128591|NCT01745627|BG000|Baseline|Laser Treatment|755nm Alex laser
11128592|NCT01745627|FG000|Participant Flow|Laser Treatment|755nm Alex laser
11128593|NCT01745627|OG000|Outcome|Laser Treatment|755nm Alex laser
11128594|NCT01745627|EG000|Reported Event|Laser Treatment|755nm Alex laser
11128595|NCT01745822|BG000|Baseline|Tenofovir Disoproxil Fumarate|"tenofovir disoproxil fumarate, 300 mg tablets~tenofovir disoproxil fumarate: administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum"
11128596|NCT01745822|BG001|Baseline|Placebo|"matching placebo (of tenofovir disoproxil fumarate)~placebo: administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum"
11128597|NCT01745822|BG002|Baseline|Total|Total of all reporting groups
11128598|NCT01745822|FG000|Participant Flow|Tenofovir Disoproxil Fumarate|"tenofovir disoproxil fumarate, 300 mg tablets~tenofovir disoproxil fumarate: administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum"
11128599|NCT01745822|FG001|Participant Flow|Placebo|"matching placebo (of tenofovir disoproxil fumarate)~placebo: administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum"
11128600|NCT01745822|OG000|Outcome|Tenofovir Disoproxil Fumarate|"tenofovir disoproxil fumarate, 300 mg tablets~tenofovir disoproxil fumarate: administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum"
11128601|NCT01745822|OG001|Outcome|Placebo|"matching placebo (of tenofovir disoproxil fumarate)~placebo: administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum"
11128602|NCT01745822|EG000|Reported Event|Tenofovir Disoproxil Fumarate|"tenofovir disoproxil fumarate, 300 mg tablets~tenofovir disoproxil fumarate: administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum"
11128603|NCT01745822|EG001|Reported Event|Placebo|"matching placebo (of tenofovir disoproxil fumarate)~placebo: administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum"
11128604|NCT01745848|BG000|Baseline|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
11128605|NCT01745848|FG000|Participant Flow|Roflumilast|"Roflumilast 500 μcg, once daily, for 30 days~Roflumilast"
11128606|NCT01745848|OG000|Outcome|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
11128607|NCT01745848|EG000|Reported Event|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
11128608|NCT01745952|BG000|Baseline|All Participants|description of the patients at the onset of the study
11128609|NCT01745952|FG000|Participant Flow|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
11128610|NCT01745952|FG001|Participant Flow|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
11128611|NCT01745952|FG002|Participant Flow|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
11128612|NCT01745952|OG000|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
11128613|NCT01745952|OG001|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
10848983|NCT00293202|OG001|Outcome|Placebo|"No Drug - Saline injection twice a week~Hemodialysis patients will receive Saline by subcutaneous injection twice a week for a total of 52 weeks"
11128614|NCT01745952|OG002|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
11128615|NCT01745952|OG000|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
11128616|NCT01745952|OG001|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
11128617|NCT01745952|OG002|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
11128618|NCT01745952|OG001|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
11128619|NCT01745952|OG002|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
11128620|NCT01745952|OG000|Outcome|Any Difference Between the Four Conditions|effect of baseline/ figure-of-eight/ round/ sham treatment period on the seizure frequency of the patients
11128621|NCT01745952|EG000|Reported Event|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~figure-of-eight active rTMS coil: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil"
11128622|NCT01745952|EG001|Reported Event|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~round active rTMS coil: navigated rTMS over epileptogenic focus using round active rTMS coil"
11128623|NCT01745952|EG002|Reported Event|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~sham rTMS coil (figure-of-eight): placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue"
11128624|NCT01746017|BG000|Baseline|Part A Cohort 1 Sequence 1|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: Placebo; Period 2: 10 milligrams (mg) LY2922470; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;"
11128625|NCT01746017|BG001|Baseline|Part A Cohort 1 Sequence 2|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: 90mg LY2922470; Period 4: Placebo;"
11128626|NCT01746017|BG002|Baseline|Part A Cohort 1 Sequence 3|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 1mg LY2922470; Period 2: Placebo; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;"
11128627|NCT01746017|BG003|Baseline|Part A Cohort 1 Sequence 4|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: Placebo; Period 4: 540mg LY2922470;"
11128628|NCT01746017|BG004|Baseline|Part A Cohort 2 Sequence 1|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: Placebo; Period 4: 1350mg LY2922470;"
11128629|NCT01746017|BG005|Baseline|Part A Cohort 2 Sequence 2|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: Placebo;"
11128630|NCT01746017|BG006|Baseline|Part A Cohort 2 Sequence 3|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 3mg LY2922470; Period 2: Placebo; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;"
11128631|NCT01746017|BG007|Baseline|Part A Cohort 2 Sequence 4|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: Placebo; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;"
11128632|NCT01746017|BG008|Baseline|Part B Sequence 1|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: Placebo; Period 2: 540mg LY2922470; Period 3: 1080mg LY2922470;"
11128633|NCT01746017|BG009|Baseline|Part B Sequence 2|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 270mg LY2922470; Period 2: 540mg LY2922470; Period 3: Placebo;"
11128634|NCT01746017|BG010|Baseline|Part B Sequence 3|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 270mg LY2922470; Period 2: Placebo; Period 3: 1080mg LY2922470;"
11128635|NCT01746017|BG011|Baseline|Total|Total of all reporting groups
11128636|NCT01746017|FG000|Participant Flow|Part A Cohort 1 Sequence 1|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: Placebo; Period 2: 10 milligrams (mg) LY2922470; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;"
11128637|NCT01746017|FG001|Participant Flow|Part A Cohort 1 Sequence 2|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: 90mg LY2922470; Period 4: Placebo;"
11128638|NCT01746017|FG002|Participant Flow|Part A Cohort 1 Sequence 3|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 1mg LY2922470; Period 2: Placebo; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;"
10848984|NCT00293202|OG000|Outcome|Etanercept 25 mg|"Etanercept 25 mg injection twice a week~Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week"
11128639|NCT01746017|FG003|Participant Flow|Part A Cohort 1 Sequence 4|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 1mg LY2922470; Period 2: 90mg LY2922470; Period 3: Placebo; Period 4: 540mg LY2922470;"
11128640|NCT01746017|FG004|Participant Flow|Part A Cohort 2 Sequence 1|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: Placebo; Period 4: 1350mg LY2922470;"
11128641|NCT01746017|FG005|Participant Flow|Part A Cohort 2 Sequence 2|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: Placebo;"
11128642|NCT01746017|FG006|Participant Flow|Part A Cohort 2 Sequence 3|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 3mg LY2922470; Period 2: Placebo; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;"
11128643|NCT01746017|FG007|Participant Flow|Part A Cohort 2 Sequence 4|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: Placebo; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;"
11128644|NCT01746017|FG008|Participant Flow|Part B Sequence 1|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: Placebo; Period 2: 540mg LY2922470; Period 3: 1080mg LY2922470;"
11128645|NCT01746017|FG009|Participant Flow|Part B Sequence 2|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 270mg LY2922470; Period 2: 540mg LY2922470; Period 3: Placebo;"
11128646|NCT01746017|FG010|Participant Flow|Part B Sequence 3|"Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.~Period 1: 270mg LY2922470; Period 2: Placebo; Period 3: 1080mg LY2922470;"
11128647|NCT01746017|OG000|Outcome|Placebo (Part A)|Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
11128648|NCT01746017|OG001|Outcome|1 mg (Part A)|Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128649|NCT01746017|OG002|Outcome|3 mg (Part A)|Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128650|NCT01746017|OG003|Outcome|10 mg (Part A)|Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128651|NCT01746017|OG004|Outcome|30 mg (Part A)|Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128652|NCT01746017|OG005|Outcome|90 mg (Part A)|Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128653|NCT01746017|OG006|Outcome|270 mg (Part A)|Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128654|NCT01746017|OG007|Outcome|540 mg (Part A)|Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128655|NCT01746017|OG008|Outcome|1350 mg (Part A)|Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128656|NCT01746017|OG009|Outcome|Placebo (Part B)|Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
11128657|NCT01746017|OG010|Outcome|270 mg (Part B)|Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128658|NCT01746017|OG011|Outcome|540 mg (Part B)|Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128659|NCT01746017|OG012|Outcome|1080 mg (Part B)|Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128660|NCT01746017|OG000|Outcome|1 mg (Part A)|Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128661|NCT01746017|OG001|Outcome|3 mg (Part A)|Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128662|NCT01746017|OG002|Outcome|10 mg (Part A)|Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128663|NCT01746017|OG003|Outcome|30 mg (Part A)|Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128664|NCT01746017|OG004|Outcome|90 mg (Part A)|Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128665|NCT01746017|OG005|Outcome|270 mg (Part A)|Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128666|NCT01746017|OG006|Outcome|540 mg (Part A)|Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128667|NCT01746017|OG007|Outcome|1350 mg (Part A)|Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128668|NCT01746017|OG008|Outcome|270 mg (Part B)|Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128669|NCT01746017|OG009|Outcome|540 mg (Part B)|Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128670|NCT01746017|OG010|Outcome|1080 mg (Part B)|Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128671|NCT01746017|EG000|Reported Event|Placebo (Part A)|Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
11128672|NCT01746017|EG001|Reported Event|1 mg (Part A)|Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128673|NCT01746017|EG002|Reported Event|3 mg (Part A)|Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128674|NCT01746017|EG003|Reported Event|10 mg (Part A)|Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128675|NCT01746017|EG004|Reported Event|30 mg (Part A)|Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128676|NCT01746017|EG005|Reported Event|90 mg (Part A)|Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128677|NCT01746017|EG006|Reported Event|270 mg (Part A)|Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128678|NCT01746017|EG007|Reported Event|540 mg (Part A)|Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128679|NCT01746017|EG008|Reported Event|1350 mg (Part A)|Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
11128680|NCT01746017|EG009|Reported Event|Placebo (Part B)|Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
11128681|NCT01746017|EG010|Reported Event|270 mg (Part B)|Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128682|NCT01746017|EG011|Reported Event|540 mg (Part B)|Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128683|NCT01746017|EG012|Reported Event|1080 mg (Part B)|Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
11128684|NCT01746043|BG000|Baseline|Armodafinil + Placebo|Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days)
11128685|NCT01746043|BG001|Baseline|Minocycline + Placebo|Minocycline 100mg twice a day during the entire course of radiation therapy (6 weeks + 5 days)
11128686|NCT01746043|BG002|Baseline|Armodafinil + Minocycline|Armodafinil (150 mg once a day for 6 weeks) + Minocycline (100 mg twice a day for 6 weeks).
11128687|NCT01746043|BG003|Baseline|Placebo|Matching Placebo
11128688|NCT01746043|BG004|Baseline|Total|Total of all reporting groups
11128689|NCT01746043|FG000|Participant Flow|Armodafinil + Placebo|Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days).
11128690|NCT01746043|FG001|Participant Flow|Minocycline + Placebo|Minocycline 100mg twice a day during the entire course of radiation therapy (6 weeks + 5 days)
11128691|NCT01746043|FG002|Participant Flow|Armodafinil + Minocycline|Armodafinil (150 mg once a day for 6 weeks) + Minocycline (100 mg twice a day for 6 weeks).
11128692|NCT01746043|FG003|Participant Flow|Placebo|Matching Placebo
11128693|NCT01746043|OG000|Outcome|Armodafinil + Placebo|Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days)
11128694|NCT01746043|OG001|Outcome|Minocycline + Placebo|Minocycline 100mg twice a day during the entire course of radiation therapy (6 weeks + 5 days)
11128695|NCT01746043|OG002|Outcome|Armodafinil + Minocycline|Armodafinil (150mg once a day) + Minocycline (100mg once a day)
11128696|NCT01746043|OG003|Outcome|Placebos|Matching Placebo
11128697|NCT01746043|EG000|Reported Event|Armodafinil|Armodafinil 150 mg once a day during the entire course of chemoXRT (6 weeks + 5 days) or a total of 6 weeks.
11128698|NCT01746043|EG001|Reported Event|Minocycline|Minocycline 100 mg twice a day during the entire course of chemoXT ( 6 weeks + 5 days)
11128699|NCT01746043|EG002|Reported Event|Armodafinil+Minocycline|Armodafinil + Minocycline
11128700|NCT01746043|EG003|Reported Event|Placebo|Matching Placebo
11128701|NCT01746095|BG000|Baseline|AeroVanc 32 mg|Vancomycin hydrochloride inhalation powder 32 mg BID
11128702|NCT01746095|BG001|Baseline|Placebo to 32 mg|Placebo inhalation powder BID
11128703|NCT01746095|BG002|Baseline|AeroVanc 64 mg|Vancomycin hydrochloride inhalation powder 64 mg BID
11128704|NCT01746095|BG003|Baseline|Placebo to 64 mg|Placebo inhalation powder BID
11128705|NCT01746095|BG004|Baseline|Total|Total of all reporting groups
11128706|NCT01746095|FG000|Participant Flow|AeroVanc 32 mg|Vancomycin hydrochloride inhalation powder 32 mg BID
11128707|NCT01746095|FG001|Participant Flow|Placebo to 32 mg|Placebo inhalation powder BID
11128708|NCT01746095|FG002|Participant Flow|AeroVanc 64 mg|Vancomycin hydrochloride inhalation powder 64 mg BID
11128709|NCT01746095|FG003|Participant Flow|Placebo to 64 mg|Placebo inhalation powder BID
10848985|NCT00293202|OG001|Outcome|Saline|"Saline injection twice a week~Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week"
10848986|NCT00293202|EG000|Reported Event|Etanercept|"Etanercept 25 mg injection twice a week~Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week"
11128710|NCT01746095|OG000|Outcome|AeroVanc 32 mg|Vancomycin hydrochloride inhalation powder 32 mg BID
11128711|NCT01746095|OG001|Outcome|Placebo to 32 mg|Placebo inhalation powder BID
11128712|NCT01746095|OG002|Outcome|AeroVanc 64 mg|Vancomycin hydrochloride inhalation powder 64 mg BID
11128713|NCT01746095|OG003|Outcome|Placebo to 64 mg|Placebo inhalation powder BID
11128714|NCT01746095|EG000|Reported Event|AeroVanc 32 mg|Vancomycin hydrochloride inhalation powder 32 mg BID
11128715|NCT01746095|EG001|Reported Event|Placebo to 32 mg|Placebo inhalation powder BID
11128716|NCT01746095|EG002|Reported Event|AeroVanc 64 mg|Vancomycin hydrochloride inhalation powder 64 mg BID
11128717|NCT01746095|EG003|Reported Event|Placebo to 64 mg|Placebo inhalation powder BID
11128718|NCT01746108|BG000|Baseline|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
11128719|NCT01746108|BG001|Baseline|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
11128720|NCT01746108|BG002|Baseline|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
11128721|NCT01746108|BG003|Baseline|Total|Total of all reporting groups
11128722|NCT01746108|FG000|Participant Flow|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
11128723|NCT01746108|FG001|Participant Flow|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
11128724|NCT01746108|FG002|Participant Flow|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
11128725|NCT01746108|OG000|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
11149553|NCT01871506|OG001|Outcome|Intensive Treatment (IT)|"Participants randomized to IT will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive:~Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).~Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication [varenicline, bupropion, or combination NRT (patch + lozenge)] at no cost to the participant."
11008553|NCT01097577|FG001|Participant Flow|Lactose Capsule|Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
10848987|NCT00293202|EG001|Reported Event|Placebo|"Saline injection twice a week~Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week"
10848988|NCT00293215|BG000|Baseline|Cohort 1 (1.0 mg/m^2)|Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
10848989|NCT00293215|BG001|Baseline|Cohort 2 (2.6 mg/m^2)|Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
10848990|NCT00293215|BG002|Baseline|Total|Total of all reporting groups
10848991|NCT00293215|FG000|Participant Flow|Cohort 1 (1.0 mg/m^2)|Subjects received Indium-111 labelled-CMD-193 (111-In-CMD-193) (3-7 mCi) intravenously (IV) on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
10848992|NCT00293215|FG001|Participant Flow|Cohort 2 (2.6 mg/m^2)|Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
10848993|NCT00293215|OG000|Outcome|Cohort 1 (1.0 mg/m^2)|Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
10848994|NCT00293215|OG001|Outcome|Cohort 2 (2.6 mg/m^2)|Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
10848995|NCT00293215|EG000|Reported Event|Cohort 1 (1.0 mg/m^2)|Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
10848996|NCT00293215|EG001|Reported Event|Cohort 2 (2.6 mg/m^2)|Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
10848997|NCT00293241|BG000|Baseline|MVP ON|Managed Ventricular Pacing programmed on
10848998|NCT00293241|BG001|Baseline|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
10848999|NCT00293241|BG002|Baseline|Total|Total of all reporting groups
10849000|NCT00293241|FG000|Participant Flow|MVP ON|Managed Ventricular Pacing programmed on
10849001|NCT00293241|FG001|Participant Flow|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
10849002|NCT00293241|OG000|Outcome|MVP ON|Managed Ventricular Pacing programmed on
10849003|NCT00293241|OG001|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
10849004|NCT00293241|OG001|Outcome|MVP Off|Managed Ventricular Pacing programmed off: conventional pacing
10849005|NCT00293241|OG000|Outcome|MVP ON|"Managed Ventricular Pacing programmed on~Managed Ventricular Pacing programmed ON/OFF: Device programming"
10849006|NCT00293241|OG001|Outcome|MVP OFF|"Managed Ventricular Pacing programmed off: conventional pacing~Managed Ventricular Pacing programmed ON/OFF: Device programming"
10849007|NCT00293241|EG000|Reported Event|MVP ON|Managed Ventricular Pacing programmed on
10849008|NCT00293241|EG001|Reported Event|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
10849009|NCT00293254|BG000|Baseline|Raltegravir 400 mg b.i.d. + OBT|
10849010|NCT00293254|BG001|Baseline|Placebo + OBT|
10849011|NCT00293254|BG002|Baseline|Total|Total of all reporting groups
10849012|NCT00293254|FG000|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
10849013|NCT00293254|FG001|Participant Flow|Placebo + OBT|
10849014|NCT00293254|OG000|Outcome|Raltegravir 400 mg b.i.d. + OBT|
10849015|NCT00293254|OG001|Outcome|Placebo + OBT|
10849016|NCT00293254|OG000|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
10849017|NCT00293254|OG001|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
10879580|NCT00458484|OG000|Outcome|Series 1/Dose Level 1: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions: 6 Gy x 4 fractions total dose of 24 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879581|NCT00458484|OG001|Outcome|Series 1/Dose Level 2: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions: 8 Gy x 4 fractions total dose of 32 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879582|NCT00458484|OG002|Outcome|Series 1/Dose Level 3: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions: 10 Gy x 4 fractions total dose of 40 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879583|NCT00458484|OG003|Outcome|Series 1/Dose Level 4: Stereotactic Radiosurgery|"Series I: Radiation will be delivered in 4 fractions: 12 Gy x 4 fractions total dose of 48 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879584|NCT00458484|OG004|Outcome|Series 2/Dose Level 1: Stereotactic Radiosurgery|"Series II: Radiation will be delivered in 3 fractions: 16 Gy x 3 fractions total dose of 48 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879585|NCT00458484|OG005|Outcome|Series 2/Dose Level 2: Stereotactic Radiosurgery|"Series II: Radiation will be delivered in 3 fractions: 18 Gy x 3 fractions total dose of 54 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879586|NCT00458484|OG006|Outcome|Series 2/Dose Level 3: Stereotactic Radiosurgery|"Series II: Radiation will be delivered in 3 fractions: 20 Gy x 3 fractions total dose of 60 Gy.~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879587|NCT00458484|EG000|Reported Event|Series 1/Dose Level 1: Stereotactic Radiosurgery|"Dose Level I: Radiation will be delivered in 4 fractions:~6 Gy x 4 fractions: Total of 24 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
11149554|NCT01871506|OG000|Outcome|Standard Treatment|"Participants randomized to ST will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~."
10879588|NCT00458484|EG001|Reported Event|Series 1/Dose Level 2: Stereotactic Radiosurgery|"Dose Level 2: Radiation will be delivered in 4 fractions:~8 Gy x 4 fractions: Total of 32 Gy"
10879589|NCT00458484|EG002|Reported Event|Series 1/Dose Level 3: Stereotactic Radiosurgery|"Dose Level 3: Radiation will be delivered in 4 fractions:~10 Gy x 4 fractions: Total of 40 Gy"
10879590|NCT00458484|EG003|Reported Event|Series 1/Dose Level 4: Stereotactic Radiosurgery|"Dose Level 4: Radiation will be delivered in 4 fractions:~12 Gy x 4 fractions: Total of 48 Gy"
10879591|NCT00458484|EG004|Reported Event|Series 2/Dose Level 1: Stereotactic Radiosurgery|"Dose Level I: Radiation will be delivered in 3 fractions: 16 Gy X 3 fractions: Total of 48 Gy~Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.~Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF."
10879592|NCT00458484|EG005|Reported Event|Series 2/Dose Level 2: Stereotactic Radiosurgery|Dose Level 2: Radiation will be delivered in 3 fractions: 18 Gy X 3 fractions: Total of 54 Gy
10879593|NCT00458484|EG006|Reported Event|Series 2/Dose Level 3: Stereotactic Radiosurgery|Dose Level 3: Radiation will be delivered in 3 fractions: 20 Gy X 3 fractions: Total of 6 Gy
11149555|NCT01871506|OG001|Outcome|Intensive Treatment)|Participants randomized to intensive counseling IT will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the ST ar,m.
11149556|NCT01871506|OG000|Outcome|Standard Treatment (ST)|"Participants randomized to ST will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~."
10879594|NCT00458705|BG000|Baseline|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
10879595|NCT00458705|FG000|Participant Flow|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
10879596|NCT00458705|OG000|Outcome|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
10879597|NCT00458705|EG000|Reported Event|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
10879598|NCT00458783|BG000|Baseline|Prolonged RBC Storage|"Transfusion with oldest available matching RBCs.~Prolonged RBC storage: Transfusion with oldest available matching RBCs"
10879599|NCT00458783|BG001|Baseline|Short RBC Storage|"Transfusion with youngest available matching RBCs.~Short RBC storage: Transfusion with youngest available matching RBCs"
10879600|NCT00458783|BG002|Baseline|Total|Total of all reporting groups
10879601|NCT00458783|FG000|Participant Flow|Prolonged RBC Storage|"Transfusion with oldest available matching RBCs.~Prolonged RBC storage: Transfusion with oldest available matching RBCs"
10879602|NCT00458783|FG001|Participant Flow|Short RBC Storage|"Transfusion with youngest available matching RBCs.~Short RBC storage: Transfusion with youngest available matching RBCs"
10879603|NCT00458783|OG000|Outcome|Prolonged RBC Storage|"Transfusion with oldest available matching RBCs.~Prolonged RBC storage: Transfusion with oldest available matching RBCs"
10879604|NCT00458783|OG001|Outcome|Short RBC Storage|"Transfusion with youngest available matching RBCs.~Short RBC storage: Transfusion with youngest available matching RBCs"
10879605|NCT00458783|EG000|Reported Event|Prolonged RBC Storage|"Transfusion with oldest available matching RBCs.~Prolonged RBC storage: Transfusion with oldest available matching RBCs"
10879606|NCT00458783|EG001|Reported Event|Short RBC Storage|"Transfusion with youngest available matching RBCs.~Short RBC storage: Transfusion with youngest available matching RBCs"
10879607|NCT00458822|BG000|Baseline|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
10879608|NCT00458822|FG000|Participant Flow|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
10879609|NCT00458822|OG000|Outcome|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
10879610|NCT00458822|EG000|Reported Event|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
10879611|NCT00458848|BG000|Baseline|Philadelphia Positive, Imatinib Only in Induction Therapy|"In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.~Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself."
10879612|NCT00458848|FG000|Participant Flow|Philadelphia Positive, Imatinib Only in Induction Therapy|These subset of patients was treated according to amendment three, in which Imatinib was given only at induction.
10887283|NCT00499616|OG000|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
10879613|NCT00458848|OG000|Outcome|Philadelphia Positive, Imatinib Only in Induction Therapy|"In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.~Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself."
10879614|NCT00458848|EG000|Reported Event|Philadelphia Positive, Imatinib Only in Induction Therapy|"In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.~Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself."
10879615|NCT00458952|BG000|Baseline|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
10879616|NCT00458952|BG001|Baseline|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
10879617|NCT00458952|BG002|Baseline|Total|Total of all reporting groups
10879618|NCT00458952|FG000|Participant Flow|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
10879619|NCT00458952|FG001|Participant Flow|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
10879620|NCT00458952|OG000|Outcome|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
10879621|NCT00458952|EG000|Reported Event|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
10879622|NCT00459043|BG000|Baseline|Docetaxel Single Agent|
10879623|NCT00459043|BG001|Baseline|Combination of Docetaxel and Zactima|
10879624|NCT00459043|BG002|Baseline|Total|Total of all reporting groups
10879625|NCT00459043|FG000|Participant Flow|1Docetaxel Single Agent|Docetaxel 75 mg/m2 was administered every 21 days intravenously.
10879626|NCT00459043|FG001|Participant Flow|2 Combination Docetaxel and ZD6474|"Docetaxel with ZD6474~Docetaxel 75 mg/m2 was administered every 21 days intravenously. ZD6474 (Vandetanib) at 100 mg was administered as a once daily tablet given orally."
10879627|NCT00459043|OG000|Outcome|1Docetaxel Single Agent|Docetaxel Alone
10879628|NCT00459043|OG001|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
10879629|NCT00459043|EG000|Reported Event|1Docetaxel Single Agent|Docetaxel Alone
10879630|NCT00459043|EG001|Reported Event|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
10879631|NCT00459056|BG000|Baseline|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
10879632|NCT00459056|BG001|Baseline|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
10879633|NCT00459056|BG002|Baseline|Total|Total of all reporting groups
10879634|NCT00459056|FG000|Participant Flow|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for three months, then had a one month wash-out period, and then were randomized to Lisinopril + HCT for the remaining three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
10879635|NCT00459056|FG001|Participant Flow|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCT for three months, then had a one month wash-out period, and then were randomized to Carvedilol CR + Lisinopril for the remaining three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, Lisinophil was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
10879636|NCT00459056|OG000|Outcome|Carvedilol CR + Lisinopril, Then Lisinopril +HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a one month washout period, then were given Lisinopril + HCTZ for the final three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
11008554|NCT01097577|OG000|Outcome|Pregabalin|pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
10879637|NCT00459056|OG001|Outcome|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisionopril +HCTZ for the first three months, then had a one month washout period, then were given Carvedilol CR + Lisinopril for the final three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
10879638|NCT00459056|EG000|Reported Event|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
10879639|NCT00459056|EG001|Reported Event|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
10879640|NCT00459108|BG000|Baseline|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
11128726|NCT01746108|OG000|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
11128727|NCT01746108|OG000|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
11128728|NCT01746108|OG001|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
11128729|NCT01746108|OG002|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
11128730|NCT01746108|OG001|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
11128731|NCT01746108|OG000|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
11128732|NCT01746108|OG001|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
11128733|NCT01746108|OG000|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
11128734|NCT01746108|OG001|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
11128735|NCT01746108|OG002|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
11128736|NCT01746108|EG000|Reported Event|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
10879641|NCT00459108|FG000|Participant Flow|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
10879642|NCT00459108|OG000|Outcome|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
11128737|NCT01746108|EG001|Reported Event|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
11128738|NCT01746108|EG002|Reported Event|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
11128743|NCT01746225|BG000|Baseline|A: Nab-Paclitaxel 150 mg/m2 Days 1,15|"Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)"
11128744|NCT01746225|BG001|Baseline|B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15|"Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)"
11008555|NCT01097577|OG001|Outcome|Lactose Capsule|Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
11128745|NCT01746225|BG002|Baseline|C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22|"Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)"
11128746|NCT01746225|BG003|Baseline|Total|Total of all reporting groups
11128747|NCT01746225|FG000|Participant Flow|A: Nab-Paclitaxel 150 mg/m2 Days 1,15|"Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128748|NCT01746225|FG001|Participant Flow|B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15|"Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128749|NCT01746225|FG002|Participant Flow|C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22|"Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128750|NCT01746225|OG000|Outcome|A: Nab-Paclitaxel 150 mg/m2 Days 1,15|"Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128751|NCT01746225|OG001|Outcome|B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15|"Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128752|NCT01746225|OG002|Outcome|C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22|"Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128753|NCT01746225|EG000|Reported Event|A: Nab-Paclitaxel 150 mg/m2 Days 1,15|"Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128754|NCT01746225|EG001|Reported Event|B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15|"Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128755|NCT01746225|EG002|Reported Event|C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22|"Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.~nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)~*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m²."
11128756|NCT01746264|BG000|Baseline|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
11128757|NCT01746264|FG000|Participant Flow|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
11128758|NCT01746264|OG000|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
11128759|NCT01746264|EG000|Reported Event|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
11149557|NCT01871506|OG001|Outcome|Intensive Treatment (IT)|"Participants randomized to IT will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive:~."
11128760|NCT01746368|BG000|Baseline|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
11128761|NCT01746368|BG001|Baseline|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
11128762|NCT01746368|BG002|Baseline|Total|Total of all reporting groups
11128763|NCT01746368|FG000|Participant Flow|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
11128764|NCT01746368|FG001|Participant Flow|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
11128765|NCT01746368|OG000|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
11128766|NCT01746368|OG001|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
11128767|NCT01746368|EG000|Reported Event|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
11128768|NCT01746368|EG001|Reported Event|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
11128769|NCT01746420|BG000|Baseline|Placebo Control|"Dose A - sodium acetate buffer (0 mg rhPDGF-BB)~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128770|NCT01746420|BG001|Baseline|0.45 mg rhPDGF-BB|"Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128771|NCT01746420|BG002|Baseline|0.75 mg rhPDGF-BB|"Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128772|NCT01746420|BG003|Baseline|1.5 mg rhPDGF-BB|"Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128773|NCT01746420|BG004|Baseline|3.0 mg rhPDGF-BB|"Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128774|NCT01746420|BG005|Baseline|Total|Total of all reporting groups
11128775|NCT01746420|FG000|Participant Flow|Placebo Control|"Dose A - sodium acetate buffer (0 mg rhPDGF-BB)~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128776|NCT01746420|FG001|Participant Flow|0.45 mg rhPDGF-BB|"Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128777|NCT01746420|FG002|Participant Flow|0.75 mg rhPDGF-BB|"Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128778|NCT01746420|FG003|Participant Flow|1.5 mg rhPDGF-BB|"Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128779|NCT01746420|FG004|Participant Flow|3.0 mg rhPDGF-BB|"Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128780|NCT01746420|OG000|Outcome|Placebo Control|"Dose A - sodium acetate buffer (0 mg rhPDGF-BB)~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128781|NCT01746420|OG001|Outcome|0.45 mg rhPDGF-BB|"Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128782|NCT01746420|OG002|Outcome|0.75 mg rhPDGF-BB|"Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128783|NCT01746420|OG003|Outcome|1.5 mg rhPDGF-BB|"Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128784|NCT01746420|OG004|Outcome|3.0 mg rhPDGF-BB|"Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128785|NCT01746420|OG000|Outcome|Placebo Control|"Dose A - sodium acetate buffer (0 mg rhPDGF-BB)~Placebo: sodium acetate buffer (0 mg rhPDGF-BB)"
11128786|NCT01746420|EG000|Reported Event|Placebo Control|"Dose A - sodium acetate buffer (0 mg rhPDGF-BB)~Placebo: sodium acetate buffer (0 mg rhPDGF-BB)"
11128787|NCT01746420|EG001|Reported Event|0.45 mg rhPDGF-BB|"Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128788|NCT01746420|EG002|Reported Event|0.75 mg rhPDGF-BB|"Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128789|NCT01746420|EG003|Reported Event|1.5 mg rhPDGF-BB|"Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128790|NCT01746420|EG004|Reported Event|3.0 mg rhPDGF-BB|"Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB~rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection"
11128791|NCT01746511|BG000|Baseline|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
11128792|NCT01746511|BG001|Baseline|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
11128793|NCT01746511|BG002|Baseline|Total|Total of all reporting groups
11128794|NCT01746511|FG000|Participant Flow|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
11128795|NCT01746511|FG001|Participant Flow|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
11128796|NCT01746511|OG000|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
11128797|NCT01746511|OG001|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
11128798|NCT01746511|EG000|Reported Event|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
11128799|NCT01746511|EG001|Reported Event|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
11128800|NCT01746732|BG000|Baseline|Ortho-Cyclen and Ortho-Cyclen + Evacetrapib|"Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, QD for 28 days (lead-in period).~Treatment A Ortho-Cyclen administered orally, QD for 28 Days (Days 1 to 28) Treatment B Ortho-Cyclen orally, QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD for 21 days (Days 1 to 21)"
11128801|NCT01746732|FG000|Participant Flow|Ortho-Cyclen|Ortho-Cyclen (OC) of (35 microgram [mcg] ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD) for 28 days (Days 1 to 28)
11128802|NCT01746732|FG001|Participant Flow|Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB|"Treatment A OC administered orally, QD for 28 days (Days 1 to 28)~Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 milligram (mg) Evacetrapib orally, QD for 21 days (Days 1 to 21)"
11128803|NCT01746732|FG002|Participant Flow|Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA|"Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, QD for 21 days (Days 1 to 21)~Treatment A OC administered orally, QD for 28 days (Days 1 to 28)"
11128804|NCT01746732|OG000|Outcome|Ortho-Cyclen|"Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.~Ortho-Cyclen: Oral administration"
11128805|NCT01746732|OG001|Outcome|Ortho-Cyclen + Evacetrapib|Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)
11128806|NCT01746732|OG001|Outcome|Ortho-Cyclen + Evacetrapib|"Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods.~Ortho-Cyclen: Oral administration Evacetrapib: Oral administration"
11128807|NCT01746732|EG000|Reported Event|Ortho-Cyclen (Lead-in Phase)|Ortho-Cyclen oral doses of (35 mcg ethinyl estradiol and 250 mcg norgestimate) once daily for 28 days (Days 1 to 28)
11128808|NCT01746732|EG001|Reported Event|Ortho-Cyclen|"Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) in one of two treatment periods.~Ortho-Cyclen: Oral administration"
11128809|NCT01746732|EG002|Reported Event|Ortho-Cyclen + Evacetrapib|"Ortho-Cyclen administered orally for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally for 21 days (Days 1 to 21) in one of two treatment periods.~Ortho-Cyclen: Oral administration~Evacetrapib: Oral administration"
11128810|NCT01746745|BG000|Baseline|[^14C]-LY2940680|Single 100-mg LY2940680 dose containing 100 microCuries of [^14C]-LY2940680, administered as an oral solution.
11128811|NCT01746745|FG000|Participant Flow|[^14C]-LY2940680|Single 100-milligram (mg) LY2940680 dose containing 100 microCuries of carbon-14-labeled LY2940680 ([^14C]-LY2940680), administered as an oral solution.
11128812|NCT01746745|OG000|Outcome|[^14C]-LY2940680|Single 100-mg LY2940680 dose containing 100 microCuries of [^14C]-LY2940680, administered as an oral solution.
11128813|NCT01746745|EG000|Reported Event|[^14C]-LY2940680|Single 100-mg LY2940680 dose containing 100 microCuries of [^14C]-LY2940680, administered as an oral solution.
11128814|NCT01746784|BG000|Baseline|Normal Saline|Normal saline: IV solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
11128815|NCT01746784|BG001|Baseline|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128816|NCT01746784|BG002|Baseline|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128817|NCT01746784|BG003|Baseline|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128818|NCT01746784|BG004|Baseline|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128819|NCT01746784|BG005|Baseline|Total|Total of all reporting groups
11128820|NCT01746784|FG000|Participant Flow|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
11128821|NCT01746784|FG001|Participant Flow|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
11128822|NCT01746784|FG002|Participant Flow|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
11128823|NCT01746784|FG003|Participant Flow|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
11128824|NCT01746784|FG004|Participant Flow|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
11128825|NCT01746784|OG000|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
11128826|NCT01746784|OG001|Outcome|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128827|NCT01746784|OG002|Outcome|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128828|NCT01746784|OG003|Outcome|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128829|NCT01746784|OG004|Outcome|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128830|NCT01746784|OG001|Outcome|5mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128831|NCT01746784|OG002|Outcome|10mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128832|NCT01746784|OG003|Outcome|20mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128833|NCT01746784|OG004|Outcome|40mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
11128834|NCT01746784|OG000|Outcome|Normal Saline|Placebo will receive IV normal saline Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl
11128835|NCT01746784|OG001|Outcome|5mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
11128836|NCT01746784|OG002|Outcome|10mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
11128837|NCT01746784|OG003|Outcome|20mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
11128838|NCT01746784|OG004|Outcome|40mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022 in normal saline administered by infusion pump over 1-8 minutes"
11128839|NCT01746784|EG000|Reported Event|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
11128840|NCT01746784|EG001|Reported Event|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
11128841|NCT01746784|EG002|Reported Event|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
11128842|NCT01746784|EG003|Reported Event|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
11128843|NCT01746784|EG004|Reported Event|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
11128844|NCT01746862|BG000|Baseline|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
11128845|NCT01746862|BG001|Baseline|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
11128846|NCT01746862|BG002|Baseline|Total|Total of all reporting groups
11128847|NCT01746862|FG000|Participant Flow|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
11128848|NCT01746862|FG001|Participant Flow|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
11128849|NCT01746862|OG000|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
11128850|NCT01746862|OG001|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
11128851|NCT01746862|OG000|Outcome|Saizen Test Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
11128852|NCT01746862|EG000|Reported Event|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
11128853|NCT01746862|EG001|Reported Event|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
11128854|NCT01746901|BG000|Baseline|Entire Study Population|Included all participants enrolled in the study.
11128855|NCT01746901|FG000|Participant Flow|Naloxone|Naloxone hydrochloride (HCl) 0.2 milligram (mg) intravenously followed by additional 0.6 mg naloxone hydrochloride intravenously on Day 0, each dose followed by an assessment for signs and symptoms of opioid withdrawal. Participants who did not display signs and symptoms of opioid withdrawal, were assigned to either oxycodone HCl 40 mg then placebo or placebo then oxycodone HCl 40 mg group in the drug discrimination phase of the study.
11149558|NCT01871506|OG001|Outcome|Intensive Treatment (IT)|Participants randomized to IT will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive:
11149559|NCT01871506|OG000|Outcome|Standard Treatment (ST)|"Participants randomized to ST will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~S."
11128856|NCT01746901|FG001|Participant Flow|Oxycodone HCl 40 mg Then PBO|Single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 1 followed by single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study.
11128857|NCT01746901|FG002|Participant Flow|PBO Then Oxycodone HCl 40 mg|Single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 1 followed by single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study.
11128858|NCT01746901|FG003|Participant Flow|ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C|Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in second intervention period; then single dose of matching placebo (PBO) orally on Day 1 in third intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11128859|NCT01746901|FG004|Participant Flow|ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I|Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on orally on Day 1 in second intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11128860|NCT01746901|FG005|Participant Flow|ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg|Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in third intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11128861|NCT01746901|FG006|Participant Flow|OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C|Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of matching placebo (PBO) orally on Day 1 in second intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11128862|NCT01746901|FG007|Participant Flow|OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO|Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in third intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fifth intervention period; then by single dose of matching placebo (PBO) orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11128863|NCT01746901|FG008|Participant Flow|PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg|Single dose of matching placebo (PBO) orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in second intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 40 mg/4.8 mg crushed capsule (ALO-02 40 mg-I) solution orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11128864|NCT01746901|OG000|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
11128865|NCT01746901|OG001|Outcome|ALO-02 40 Mg-C|Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
11128866|NCT01746901|OG002|Outcome|OXY 40 mg|Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
11128867|NCT01746901|OG003|Outcome|ALO-02 60 Mg-I|Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
11128868|NCT01746901|OG004|Outcome|ALO-02 60 mg- C|Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
11128869|NCT01746901|OG005|Outcome|OXY 60 mg|Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
11128870|NCT01746901|OG000|Outcome|ALO-02 40 Mg-C|Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
11128871|NCT01746901|OG001|Outcome|OXY 40 mg|Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
11128872|NCT01746901|OG002|Outcome|ALO-02 60 Mg-I|Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
11128873|NCT01746901|OG003|Outcome|ALO-02 60 mg- C|Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
11128874|NCT01746901|OG004|Outcome|OXY 60 mg|Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
11128875|NCT01746901|OG000|Outcome|ALO-02 40 Mg-C|Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
11128876|NCT01746901|OG001|Outcome|ALO-02 60 Mg-I|Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
11128877|NCT01746901|OG002|Outcome|ALO-02 60 Mg-C|Single dose of ALO-02 60 mg/7.2 mg crushed tablet (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
11128878|NCT01746901|OG000|Outcome|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
11128879|NCT01746901|OG001|Outcome|Oxycodone HCl 40 mg|Single dose of oxycodone HCl 40 mg crushed tablet solution orally on either of 2 days in drug discrimination phase.
11128880|NCT01746901|OG002|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl crushed tablet solution orally on either of 2 days in drug discrimination phase.
11128881|NCT01746901|OG003|Outcome|Placebo|Single dose of matching placebo orally in either of the first to sixth intervention periods.
11128882|NCT01746901|OG004|Outcome|ALO-02 40 Mg-C|Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
11128883|NCT01746901|OG005|Outcome|OXY 40 mg|Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
11128884|NCT01746901|OG006|Outcome|ALO-02 60 Mg-I|Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
11128885|NCT01746901|OG007|Outcome|ALO-02 60 mg- C|Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
11128886|NCT01746901|OG008|Outcome|OXY 60 mg|Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
11128887|NCT01746901|OG006|Outcome|Oxycodone HCl 40 mg|Single dose of oxycodone HCl 40 mg crushed tablet solution orally on either of 2 days in drug discrimination phase.
11128888|NCT01746901|OG007|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl crushed tablet solution orally on either of 2 days in drug discrimination phase.
11128889|NCT01746901|EG000|Reported Event|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
11128890|NCT01746901|EG001|Reported Event|Oxycodone HCl 40 mg|Single dose of oxycodone HCl 40 mg crushed tablet solution orally on either of 2 days in drug discrimination phase.
11128891|NCT01746901|EG002|Reported Event|Placebo|Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
11128892|NCT01746901|EG003|Reported Event|ALO-02 40 Mg-C|Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
11128893|NCT01746901|EG004|Reported Event|OXY 40 mg|Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
11128894|NCT01746901|EG005|Reported Event|ALO-02 60 Mg-I|Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
11128895|NCT01746901|EG006|Reported Event|ALO-02 60 Mg-C|Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
11128896|NCT01746901|EG007|Reported Event|OXY 60 mg|Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
11128897|NCT01746901|EG008|Reported Event|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl crushed tablet solution orally on either of 2 days in drug discrimination phase.
11128898|NCT01746940|BG000|Baseline|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
11128899|NCT01746940|BG001|Baseline|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
11128900|NCT01746940|BG002|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
11128901|NCT01746940|BG003|Baseline|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
11128902|NCT01746940|BG004|Baseline|Total|Total of all reporting groups
11128903|NCT01746940|FG000|Participant Flow|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
11128904|NCT01746940|FG001|Participant Flow|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
11128905|NCT01746940|FG002|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
11128906|NCT01746940|FG003|Participant Flow|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
11128907|NCT01746940|OG000|Outcome|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
11128908|NCT01746940|OG001|Outcome|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
11128909|NCT01746940|OG002|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
11128910|NCT01746940|EG000|Reported Event|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
11128911|NCT01746940|EG001|Reported Event|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
11128912|NCT01746940|EG002|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
11128913|NCT01746979|BG000|Baseline|Gemcitabine Plus TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11128914|NCT01746979|BG001|Baseline|Gemcitabine Plus Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11128915|NCT01746979|BG002|Baseline|Total|Total of all reporting groups
11128916|NCT01746979|FG000|Participant Flow|Gemcitabine Plus TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11128917|NCT01746979|FG001|Participant Flow|Gemcitabine Plus Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11128918|NCT01746979|OG000|Outcome|Gemcitabine Plus TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11128919|NCT01746979|OG001|Outcome|Gemcitabine Plus Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11128920|NCT01746979|EG000|Reported Event|TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11128921|NCT01746979|EG001|Reported Event|Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11128922|NCT01747330|BG000|Baseline|Creon Micro, Minimicrospheres|Pancreatin: Doses of pancreatin <2500 lipase u/kg/feed or <4000 lipase u/g fat/intake or <10000 lipase u/kg/day given orally are used
11128923|NCT01747330|FG000|Participant Flow|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
11128924|NCT01747330|OG000|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
11128925|NCT01747330|EG000|Reported Event|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
11128926|NCT01747343|BG000|Baseline|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
11128927|NCT01747343|FG000|Participant Flow|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
11128928|NCT01747343|OG000|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
11128929|NCT01747343|EG000|Reported Event|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
11128930|NCT01747486|BG000|Baseline|Target Dose of 1-5x10e8|"Arm 1: Target dose of 1-5x10e8 CART-19 cells (calculated as range of 10-50% transduced cells in 1 x10e9 total cells)~CART-19: CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)~Note: For baseline measures, subjects from stage 1 (15) and stage 2 (12) are combined to have total 27 subjects. In stage 2, higher dose arm (arm 1) was chosen based on the stage 1 analysis performed to expand and enrolled 12 additional subjects."
11128931|NCT01747486|BG001|Baseline|Target Dose of 1-5x10e7|"Arm 2: Target dose of 1-5x10e7 CART-19 cells (calculated as the range of 10-50% transduced cells in 1 x10e8 total cells)~CART-19: CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)~Note: In stage 1, 15 subject were enrolled in this arm. Since this arm was not chosen for stage 2, no additional subjects were enrolled. total subjects in this arm were 15."
11128932|NCT01747486|BG002|Baseline|Total|Total of all reporting groups
11128933|NCT01747486|FG000|Participant Flow|Target Dose of 1-5x10e8|"Arm 1: Target dose of 1-5x10e8 CART-19 cells (calculated as range of 10-50% transduced cells in 1 x10e9 total cells)~CART-19: CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)"
11128934|NCT01747486|FG001|Participant Flow|Target Dose of 1-5x10e7|"Arm 2: Target dose of 1-5x10e7 CART-19 cells (calculated as the range of 10-50% transduced cells in 1 x10e8 total cells)~CART-19: CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)"
11128935|NCT01747486|OG000|Outcome|Target Dose of 1-5x10e8|"Arm 1: Target dose of 1-5x10e8 CART-19 cells (calculated as range of 10-50% transduced cells in 1 x10e9 total cells)~CART-19: CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)"
11128936|NCT01747486|OG001|Outcome|Target Dose of 1-5x10e7|"Arm 2: Target dose of 1-5x10e7 CART-19 cells (calculated as the range of 10-50% transduced cells in 1 x10e8 total cells)~CART-19: CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)"
11128937|NCT01747486|EG000|Reported Event|Target Dose of 1-5x10e8|"Arm 1: Target dose of 1-5x10e8 CART-19 cells (calculated as range of 10-50% transduced cells in 1 x10e9 total cells)~CART-19: CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)~Note: For this group, subjects from stage 1 (15) and stage 2 (12) are combined to have total 27 subjects. In stage 2, higher dose arm (arm 1) was chosen based on the stage 1 analysis performed to expand and enrolled 12 additional subjects."
11128938|NCT01747486|EG001|Reported Event|Target Dose of 1-5x10e7|"Arm 2: Target dose of 1-5x10e7 CART-19 cells (calculated as the range of 10-50% transduced cells in 1 x10e8 total cells)~CART-19: CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)~Note: In stage 1, 15 subject were enrolled in this arm. Since this arm was not chosen for stage 2, no additional subjects were enrolled. total subjects in this arm were 15."
11128939|NCT01747499|BG000|Baseline|Cohort 1|"Conditioning treatment~Transplant on Day 0~15 mg/m^2 azacitidine Days 7-11~15 mg/m^2 azacitidine Days 35-39~15 mg/m^2 azacitidine Days 63-67~15 mg/m^2 azacitidine Days 91-95"
11128940|NCT01747499|BG001|Baseline|Cohort 2|"Conditioning treatment~Transplant on Day 0~30 mg/m^2 azacitidine Days 7-11~30 mg/m^2 azacitidine Days 35-39~30 mg/m^2 azacitidine Days 63-67~30 mg/m^2 azacitidine Days 91-95"
11128941|NCT01747499|BG002|Baseline|Cohort 3|"Conditioning treatment~Transplant on Day 0~37.5 mg/m^2 azacitidine Days 7-11~37.5 mg/m^2 azacitidine Days 35-39~37.5 mg/m^2 azacitidine Days 63-67~37.5 mg/m^2 azacitidine Days 91-95"
11128942|NCT01747499|BG003|Baseline|Cohort 4|"Conditioning treatment~Transplant on Day 0~45 mg/m^2 azacitidine Days 7-11~45 mg/m^2 azacitidine Days 35-39~45 mg/m^2 azacitidine Days 63-67~45 mg/m^2 azacitidine Days 91-95"
11128943|NCT01747499|BG004|Baseline|Phase II Cohort|"Conditioning treatment~Transplant on Day 0~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 7-11~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 35-39~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 63-67~Dose determined in Phase I - 45 mg/m^2 attitudinize Days 91-95"
11128944|NCT01747499|BG005|Baseline|Total|Total of all reporting groups
11128945|NCT01747499|FG000|Participant Flow|Cohort 1|"Conditioning treatment~Transplant on Day 0~15 mg/m^2 azacitidine Days 7-11~15 mg/m^2 azacitidine Days 35-39~15 mg/m^2 azacitidine Days 63-67~15 mg/m^2 azacitidine Days 91-95"
11128946|NCT01747499|FG001|Participant Flow|Cohort 2|"Conditioning treatment~Transplant on Day 0~30 mg/m^2 azacitidine Days 7-11~30 mg/m^2 azacitidine Days 35-39~30 mg/m^2 azacitidine Days 63-67~30 mg/m^2 azacitidine Days 91-95"
11128947|NCT01747499|FG002|Participant Flow|Cohort 3|"Conditioning treatment~Transplant on Day 0~37.5 mg/m^2 azacitidine Days 7-11~37.5 mg/m^2 azacitidine Days 35-39~37.5 mg/m^2 azacitidine Days 63-67~37.5 mg/m^2 azacitidine Days 91-95"
11128948|NCT01747499|FG003|Participant Flow|Cohort 4|"Conditioning treatment~Transplant on Day 0~45 mg/m^2 azacitidine Days 7-11~45 mg/m^2 azacitidine Days 35-39~45 mg/m^2 azacitidine Days 63-67~45 mg/m^2 azacitidine Days 91-95"
11128949|NCT01747499|FG004|Participant Flow|Phase II Cohort|"Conditioning treatment~Transplant on Day 0~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 7-11~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 35-39~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 63-67~Dose determined in Phase I - 45 mg/m^2 attitudinize Days 91-95"
11128950|NCT01747499|OG000|Outcome|Phase I|"Conditioning treatment~Transplant on Day 0~Azacitidine Days 7-11~Azacitidine Days 35-39~Azacitidine Days 63-67~Azacitidine Days 91-95"
11128951|NCT01747499|OG000|Outcome|Phase II Cohort|"Conditioning treatment~Transplant on Day 0~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 7-11~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 35-39~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 63-67~Dose determined in Phase I - 45 mg/m^2 attitudinize Days 91-95"
11128952|NCT01747499|OG000|Outcome|Cohort 1|"Conditioning treatment~Transplant on Day 0~15 mg/m^2 azacitidine Days 7-11~15 mg/m^2 azacitidine Days 35-39~15 mg/m^2 azacitidine Days 63-67~15 mg/m^2 azacitidine Days 91-95"
11128953|NCT01747499|OG001|Outcome|Cohort 2|"Conditioning treatment~Transplant on Day 0~30 mg/m^2 azacitidine Days 7-11~30 mg/m^2 azacitidine Days 35-39~30 mg/m^2 azacitidine Days 63-67~30 mg/m^2 azacitidine Days 91-95"
11128954|NCT01747499|OG002|Outcome|Cohort 3|"Conditioning treatment~Transplant on Day 0~37.5 mg/m^2 azacitidine Days 7-11~37.5 mg/m^2 azacitidine Days 35-39~37.5 mg/m^2 azacitidine Days 63-67~37.5 mg/m^2 azacitidine Days 91-95"
11128955|NCT01747499|OG003|Outcome|Cohort 4|"Conditioning treatment~Transplant on Day 0~45 mg/m^2 azacitidine Days 7-11~45 mg/m^2 azacitidine Days 35-39~45 mg/m^2 azacitidine Days 63-67~45 mg/m^2 azacitidine Days 91-95"
11128956|NCT01747499|OG004|Outcome|Phase II Cohort|"Conditioning treatment~Transplant on Day 0~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 7-11~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 35-39~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 63-67~Dose determined in Phase I - 45 mg/m^2 attitudinize Days 91-95"
11128957|NCT01747499|EG000|Reported Event|Cohort 1|"Conditioning treatment~Transplant on Day 0~15 mg/m^2 azacitidine Days 7-11~15 mg/m^2 azacitidine Days 35-39~15 mg/m^2 azacitidine Days 63-67~15 mg/m^2 azacitidine Days 91-95"
11128958|NCT01747499|EG001|Reported Event|Cohort 2|"Conditioning treatment~Transplant on Day 0~30 mg/m^2 azacitidine Days 7-11~30 mg/m^2 azacitidine Days 35-39~30 mg/m^2 azacitidine Days 63-67~30 mg/m^2 azacitidine Days 91-95"
11128959|NCT01747499|EG002|Reported Event|Cohort 3|"Conditioning treatment~Transplant on Day 0~37.5 mg/m^2 azacitidine Days 7-11~37.5 mg/m^2 azacitidine Days 35-39~37.5 mg/m^2 azacitidine Days 63-67~37.5 mg/m^2 azacitidine Days 91-95"
11128960|NCT01747499|EG003|Reported Event|Cohort 4|"Conditioning treatment~Transplant on Day 0~45 mg/m^2 azacitidine Days 7-11~45 mg/m^2 azacitidine Days 35-39~45 mg/m^2 azacitidine Days 63-67~45 mg/m^2 azacitidine Days 91-95"
11128961|NCT01747499|EG004|Reported Event|Phase II Cohort|"Conditioning treatment~Transplant on Day 0~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 7-11~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 35-39~Dose determined in Phase I - 45 mg/m^2 azacitidine Days 63-67~Dose determined in Phase I - 45 mg/m^2 attitudinize Days 91-95"
11128962|NCT01747551|BG000|Baseline|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
11128963|NCT01747551|BG001|Baseline|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
11128964|NCT01747551|BG002|Baseline|Total|Total of all reporting groups
11128965|NCT01747551|FG000|Participant Flow|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
11128966|NCT01747551|FG001|Participant Flow|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
11128967|NCT01747551|OG000|Outcome|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
11128968|NCT01747551|OG001|Outcome|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
11128969|NCT01747551|EG000|Reported Event|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
11128970|NCT01747551|EG001|Reported Event|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
11128971|NCT01747629|BG000|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
11128972|NCT01747629|BG001|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
11128973|NCT01747629|BG002|Baseline|Total|Total of all reporting groups
11128974|NCT01747629|FG000|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
11128975|NCT01747629|FG001|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
11128976|NCT01747629|OG000|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
11128977|NCT01747629|OG001|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
11128978|NCT01747629|EG000|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
11128979|NCT01747629|EG001|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
11128980|NCT01747655|BG000|Baseline|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
11128981|NCT01747655|FG000|Participant Flow|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
11128982|NCT01747655|FG001|Participant Flow|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
11128983|NCT01747655|OG000|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
11128984|NCT01747655|OG001|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
11128985|NCT01747655|OG001|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications.
11128986|NCT01747655|EG000|Reported Event|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy
11128987|NCT01747772|BG000|Baseline|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
11128988|NCT01747772|FG000|Participant Flow|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
11128989|NCT01747772|OG000|Outcome|Fibrosis 0|Participants with no fibrosis on liver biopsy evaluation.
11128990|NCT01747772|OG001|Outcome|Fibrosis 1|Participants with portal fibrosis without septa on liver biopsy evaluation.
11128991|NCT01747772|OG002|Outcome|Fibrosis 2|Participants with portal fibrosis with few septa on liver biopsy evaluation.
11128992|NCT01747772|OG003|Outcome|Fibrosis 3|Participants with numerous septa without cirrhosis on liver biopsy evaluation.
11128993|NCT01747772|OG004|Outcome|Fibrosis 4|Participants with cirrhosis on liver biopsy evaluation.
11128994|NCT01747772|EG000|Reported Event|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
11128995|NCT01747811|BG000|Baseline|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11128996|NCT01747811|BG001|Baseline|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
11128997|NCT01747811|BG002|Baseline|Total|Total of all reporting groups
11128998|NCT01747811|FG000|Participant Flow|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
11128999|NCT01747811|FG001|Participant Flow|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
11129000|NCT01747811|OG000|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11129001|NCT01747811|OG001|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
11129002|NCT01747811|OG001|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11129003|NCT01747811|OG000|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
11129004|NCT01747811|EG000|Reported Event|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
11129005|NCT01747811|EG001|Reported Event|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
11129006|NCT01747837|BG000|Baseline|Standard ICD Implantation Alone|These subjects will undergo standard ICD implantation alone (if not already present)
11129007|NCT01747837|BG001|Baseline|Boston Scientific Vessix Renal Denervation System|"These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.~Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.~Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts"
11129008|NCT01747837|BG002|Baseline|Total|Total of all reporting groups
11129009|NCT01747837|FG000|Participant Flow|Standard ICD Implantation Alone|These subjects will undergo standard ICD implantation alone (if not already present)
11129010|NCT01747837|FG001|Participant Flow|Boston Scientific Vessix Renal Denervation System|"These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.~Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.~Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts"
11129011|NCT01747837|OG000|Outcome|Standard ICD Implantation Alone|These subjects will undergo standard ICD implantation alone (if not already present)
11342016|NCT03694925|EG001|Reported Event|Aseptic Revision Total Knee Arthroplasty|"There will be n=70 aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11129012|NCT01747837|OG001|Outcome|Boston Scientific Vessix Renal Denervation System|"These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.~Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.~Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts"
11129013|NCT01747837|EG000|Reported Event|Standard ICD Implantation Alone|These subjects will undergo standard ICD implantation alone (if not already present)
11129014|NCT01747837|EG001|Reported Event|Boston Scientific Vessix Renal Denervation System|"These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.~Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.~Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts"
11129015|NCT01747850|BG000|Baseline|Sativex|"Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.~Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal)."
11129016|NCT01747850|BG001|Baseline|Placebo Spray|"Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy~Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%)."
11129017|NCT01747850|BG002|Baseline|Pilot Study|"The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.~All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.~Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal)."
11129018|NCT01747850|BG003|Baseline|Total|Total of all reporting groups
11129019|NCT01747850|FG000|Participant Flow|Pilot Study|"The first five subjects will be treatment-seekers that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.~Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.~Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal)."
11129020|NCT01747850|FG001|Participant Flow|Sativex|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). Study subjects will be randomized in blocks of ten to one of the two groups (Sativex vs. placebo) in a double blind manner. There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
11129021|NCT01747850|FG002|Participant Flow|Placebo Spray|"Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy~Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure)."
11129022|NCT01747850|OG000|Outcome|Sativex # of Participants That Withdrew Due SAE|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
11129023|NCT01747850|OG001|Outcome|Placebo # of Participants That Withdrew Due SAE|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
11342017|NCT03694925|EG002|Reported Event|Revision Septic Total Knee Arthroplasty|"There will be n=50 septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11129024|NCT01747850|OG002|Outcome|Pilot Study # of Participants That Withdrew Due SAE|"The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.~Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.~Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if"
11129025|NCT01747850|OG000|Outcome|Sativex % Days Use of Cannabis|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
11129026|NCT01747850|OG001|Outcome|Placebo % Days Use of Cannabis|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
11129027|NCT01747850|OG002|Outcome|Pilot % Days Use of Cannabis|The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
11129028|NCT01747850|OG000|Outcome|Sativex Withdrawal|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
11129029|NCT01747850|OG001|Outcome|Placebo Withdrawal|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
11129030|NCT01747850|OG002|Outcome|Pilot Withdrawal|The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
11129031|NCT01747850|OG000|Outcome|Sativex Craving|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
11129032|NCT01747850|OG001|Outcome|Placebo Craving|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
11129033|NCT01747850|OG002|Outcome|Pilot Craving|The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
11129034|NCT01747850|OG000|Outcome|Sativex Cannabis Use (g)|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
11129035|NCT01747850|OG001|Outcome|Placebo Cannabis Use (g)|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
11129036|NCT01747850|OG002|Outcome|Pilot Cannabis Use (g)|The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
11129037|NCT01747850|EG000|Reported Event|Sativex|"Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure.~All participants will receive a combination of pharmacotherapy (Sativex ) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy."
11129038|NCT01747850|EG001|Reported Event|Placebo Spray|"Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks Placebo treatment exposure.~Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy"
11129039|NCT01747850|EG002|Reported Event|Pilot Study|"The first five subjects will be treatment-seekers that will be treated open-label.~Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks medication treatment exposure).~Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy."
11129040|NCT01747876|BG000|Baseline|LEE011 280 mg/m2 - Dose Escalation Only|Patients who took 280 mg/m2 of LEE011
11129041|NCT01747876|BG001|Baseline|LEE011 350 mg/m2 - Dose Escalation Only|Patients who took 350 mg/m2 of LEE011. The dose escalation part of the study
11129042|NCT01747876|BG002|Baseline|LEE011 470 mg/m2 - Dose Escalation Only|Patients who took 470 mg/m2 of LEE011
11129043|NCT01747876|BG003|Baseline|Total|Total of all reporting groups
11129044|NCT01747876|FG000|Participant Flow|LEE011 280 mg/m2 - Dose Escalation Only|Patients who took 280 mg/m2 of LEE011
11129045|NCT01747876|FG001|Participant Flow|LEE011 350 mg/m2 - Dose Escalation Only|Patients who took 350 mg/m2 of LEE011. The dose escalation part of the study
11129046|NCT01747876|FG002|Participant Flow|LEE011 470 mg/m2 - Dose Escalation Only|Patients who took 470 mg/m2 of LEE011
11129047|NCT01747876|OG000|Outcome|LEE011 280 mg/m2 - Dose Escalation Only|Patients who took 280 mg/m2 of LEE011
11129048|NCT01747876|OG001|Outcome|LEE011 350 mg/m2 - Dose Escalation Only|Patients who took 350 mg/m2 of LEE011. The dose escalation part of the study
11129049|NCT01747876|OG002|Outcome|LEE011 470 mg/m2 - Dose Escalation Only|Patients who took 470 mg/m2 of LEE011
11129050|NCT01747876|OG000|Outcome|MRT Group|Patients had a confirmed diagnosis of malignant rhabdoid tumors
11129051|NCT01747876|OG001|Outcome|Neuroblastoma (NB)|Patients had a confirmed diagnosis of neuroblastoma.
11129052|NCT01747876|EG000|Reported Event|LEE011 280 mg/m2 - Dose Escalation Only|Patients who took 280 mg/m2 of LEE011
11129053|NCT01747876|EG001|Reported Event|LEE011 350 mg/m2 - Dose Escalation Only|Patients who took 350 mg/m2 of LEE011. The dose escalation part of the study
11129054|NCT01747876|EG002|Reported Event|LEE011 470 mg/m2 - Dose Escalation Only|Patients who took 470 mg/m2 of LEE011
11129055|NCT01747876|EG003|Reported Event|All Patients|All patients who took either 280 mg/m2 or 350 mg/m2 or 470 mg/m2 of LEE011
11129056|NCT01747915|BG000|Baseline|Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day|Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
11129057|NCT01747915|BG001|Baseline|Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day|Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
11129058|NCT01747915|BG002|Baseline|Placebo|Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
11129059|NCT01747915|BG003|Baseline|Total|Total of all reporting groups
11129060|NCT01747915|FG000|Participant Flow|Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day|Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
11129061|NCT01747915|FG001|Participant Flow|Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day|Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
11129062|NCT01747915|FG002|Participant Flow|Placebo|Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
11129063|NCT01747915|OG000|Outcome|Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day|Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
11129064|NCT01747915|OG001|Outcome|Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day|Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
11129065|NCT01747915|OG002|Outcome|Placebo|Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
11342018|NCT03695094|BG000|Baseline|Group 1 (Inducers)|Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 milligrams per day (mg/day), which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
11008556|NCT01097577|EG000|Reported Event|Pregabalin|pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
11008557|NCT01097577|EG001|Reported Event|Lactose Capsule|Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
11008558|NCT01097616|BG000|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008559|NCT01097616|BG001|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008560|NCT01097616|BG002|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
11008561|NCT01097616|BG003|Baseline|Total|Total of all reporting groups
11008562|NCT01097616|FG000|Participant Flow|Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
11008563|NCT01097616|FG001|Participant Flow|Suvorexant High Dose (HD) (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
11008564|NCT01097616|FG002|Participant Flow|Placebo (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase, and could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
11008565|NCT01097616|FG003|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
11008566|NCT01097616|FG004|Participant Flow|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008567|NCT01097616|FG005|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
11008568|NCT01097616|FG006|Participant Flow|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008569|NCT01097616|FG007|Participant Flow|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008570|NCT01097616|OG000|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008571|NCT01097616|OG001|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
11008572|NCT01097616|OG000|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008573|NCT01097616|OG001|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008574|NCT01097616|OG002|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
11008575|NCT01097616|EG000|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008576|NCT01097616|EG001|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008577|NCT01097616|EG002|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
11008578|NCT01097616|EG003|Reported Event|Suvorexant LD (EXT Phase)|After receiving suvorexant LD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
11008579|NCT01097616|EG004|Reported Event|Suvorexant HD (EXT Phase)|After receiving suvorexant HD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
11008580|NCT01097616|EG005|Reported Event|Placebo (EXT Phase)|After receiving placebo to suvorexant during the 3-month DB TRT Phase, participants could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
11008581|NCT01097616|EG006|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
11008582|NCT01097616|EG007|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11129066|NCT01747915|EG000|Reported Event|Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day|Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
11129067|NCT01747915|EG001|Reported Event|Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day|Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
11129068|NCT01747915|EG002|Reported Event|Placebo|Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
11129069|NCT01747928|BG000|Baseline|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129070|NCT01747928|BG001|Baseline|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129071|NCT01747928|BG002|Baseline|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129072|NCT01747928|BG003|Baseline|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129073|NCT01747928|BG004|Baseline|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129074|NCT01747928|BG005|Baseline|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129075|NCT01747928|BG006|Baseline|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129076|NCT01747928|BG007|Baseline|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129077|NCT01747928|BG008|Baseline|Total|Total of all reporting groups
11129078|NCT01747928|FG000|Participant Flow|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129079|NCT01747928|FG001|Participant Flow|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129080|NCT01747928|FG002|Participant Flow|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129081|NCT01747928|FG003|Participant Flow|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129082|NCT01747928|FG004|Participant Flow|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129083|NCT01747928|FG005|Participant Flow|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129084|NCT01747928|FG006|Participant Flow|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129085|NCT01747928|FG007|Participant Flow|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129086|NCT01747928|OG000|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129087|NCT01747928|OG001|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129088|NCT01747928|OG002|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129089|NCT01747928|OG003|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129090|NCT01747928|OG004|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129091|NCT01747928|OG005|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129092|NCT01747928|OG006|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129093|NCT01747928|OG007|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129094|NCT01747928|OG008|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
11129095|NCT01747928|EG000|Reported Event|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129096|NCT01747928|EG001|Reported Event|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129097|NCT01747928|EG002|Reported Event|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129098|NCT01747928|EG003|Reported Event|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129099|NCT01747928|EG004|Reported Event|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129100|NCT01747928|EG005|Reported Event|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129101|NCT01747928|EG006|Reported Event|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129102|NCT01747928|EG007|Reported Event|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
11129103|NCT01748045|BG000|Baseline|Inhaled Nitric Oxide|"iNO to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
11129104|NCT01748045|BG001|Baseline|Nitrogen Gas|"Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
11129105|NCT01748045|BG002|Baseline|Total|Total of all reporting groups
11129106|NCT01748045|FG000|Participant Flow|Inhaled Nitric Oxide (iNO)|"Number of participants who have started on iNO at 20 parts per million (ppm) for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
11129107|NCT01748045|FG001|Participant Flow|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
11129108|NCT01748045|OG000|Outcome|Inhaled Nitric Oxide|"Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
11129109|NCT01748045|OG001|Outcome|Nitrogen Gas|"Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
11129110|NCT01748045|OG000|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
11129111|NCT01748045|OG001|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
11129112|NCT01748045|OG001|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas which was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
11129113|NCT01748045|OG000|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose were then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
11129114|NCT01748045|OG001|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose were then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
11129115|NCT01748045|OG001|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
11129116|NCT01748045|EG000|Reported Event|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
11129117|NCT01748045|EG001|Reported Event|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
11129118|NCT01748071|BG000|Baseline|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
11129119|NCT01748071|BG001|Baseline|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
11129120|NCT01748071|BG002|Baseline|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
11129121|NCT01748071|BG003|Baseline|Total|Total of all reporting groups
10849110|NCT00294047|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11129122|NCT01748071|FG000|Participant Flow|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
11129123|NCT01748071|FG001|Participant Flow|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
11129124|NCT01748071|FG002|Participant Flow|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
11129125|NCT01748071|OG000|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
11129126|NCT01748071|OG001|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
11129127|NCT01748071|OG002|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
11129128|NCT01748071|EG000|Reported Event|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
11129129|NCT01748071|EG001|Reported Event|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
11129130|NCT01748071|EG002|Reported Event|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
11129131|NCT01748227|BG000|Baseline|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
11129132|NCT01748227|FG000|Participant Flow|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
11129133|NCT01748227|OG000|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
11129134|NCT01748227|OG000|Outcome|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
11129135|NCT01748227|EG000|Reported Event|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
11129136|NCT01748240|BG000|Baseline|Azacitidine and Oral Vorinostat|"Patients who meet eligibility criteria will be administered vorinostat orally at 300mg two times daily for 7 days. AZA will be administered SC at 75 mg/m2/day x 7 consecutive days or at maximum tolerated dose if a dose reduction of AZA was needed before entering the trial with a minimum dose of 50mg/m2/d for 7 consecutive days.~Each cycle will last 28 days with AZA starting on day 1 of each cycle and vorinostat starting on day 3.~Azacitidine and oral vorinostat: In patients still responding after six cycles, the drugs will continue to be supplied, and follow up until death or unacceptable tolerance will be continued in all patients."
11129137|NCT01748240|FG000|Participant Flow|Azacitidine and Oral Vorinostat|"Patients who meet eligibility criteria will be administered vorinostat orally at 300mg two times daily for 7 days. AZA will be administered SC at 75 mg/m2/day x 7 consecutive days or at maximum tolerated dose if a dose reduction of AZA was needed before entering the trial with a minimum dose of 50mg/m2/d for 7 consecutive days.~Each cycle will last 28 days with AZA starting on day 1 of each cycle and vorinostat starting on day 3.~Azacitidine and oral vorinostat: In patients still responding after six cycles, the drugs will continue to be supplied, and follow up until death or unacceptable tolerance will be continued in all patients."
11129138|NCT01748240|OG000|Outcome|Azacitidine and Oral Vorinostat|"Patients who meet eligibility criteria will be administered vorinostat orally at 300mg two times daily for 7 days. AZA will be administered SC at 75 mg/m2/day x 7 consecutive days or at maximum tolerated dose if a dose reduction of AZA was needed before entering the trial with a minimum dose of 50mg/m2/d for 7 consecutive days.~Each cycle will last 28 days with AZA starting on day 1 of each cycle and vorinostat starting on day 3.~Azacitidine and oral vorinostat: In patients still responding after six cycles, the drugs will continue to be supplied, and follow up until death or unacceptable tolerance will be continued in all patients."
11129139|NCT01748240|EG000|Reported Event|Azacitidine and Oral Vorinostat|"Patients who meet eligibility criteria will be administered vorinostat orally at 300mg two times daily for 7 days. AZA will be administered SC at 75 mg/m2/day x 7 consecutive days or at maximum tolerated dose if a dose reduction of AZA was needed before entering the trial with a minimum dose of 50mg/m2/d for 7 consecutive days.~Each cycle will last 28 days with AZA starting on day 1 of each cycle and vorinostat starting on day 3.~Azacitidine and oral vorinostat: In patients still responding after six cycles, the drugs will continue to be supplied, and follow up until death or unacceptable tolerance will be continued in all patients."
11129140|NCT01748292|BG000|Baseline|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
11129141|NCT01748292|BG001|Baseline|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
11129142|NCT01748292|BG002|Baseline|Total|Total of all reporting groups
11129143|NCT01748292|FG000|Participant Flow|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
11129144|NCT01748292|FG001|Participant Flow|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
11129145|NCT01748292|OG000|Outcome|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
11129146|NCT01748292|OG001|Outcome|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
11129147|NCT01748292|EG000|Reported Event|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
11129148|NCT01748292|EG001|Reported Event|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
11129149|NCT01748552|BG000|Baseline|Part A, Cohort 1, Sequence 1|"Healthy participants received a single oral dose of the following:~Period 1: Placebo Period 2: 1.5 milligrams (mg) LY2922083 Period 3: 5 mg LY2922083"
11129150|NCT01748552|BG001|Baseline|Part A, Cohort 1, Sequence 2|"Healthy participants received a single oral dose of the following:~Period 1: 0.5 mg LY2922083 Period 2: Placebo Period 3: 5 mg LY2922083"
11129151|NCT01748552|BG002|Baseline|Part A, Cohort 1, Sequence 3|"Healthy participants received a single oral dose of the following:~Period 1: 0.5 mg LY2922083 Period 2: 1.5 mg LY2922083 Period 3: Placebo"
11129152|NCT01748552|BG003|Baseline|Part A, Cohort 2, Sequence 1|"Healthy participants received a single oral dose of the following:~Period 1: Placebo Period 2: 50 mg LY2922083 Period 3: 150 mg LY2922083"
11129153|NCT01748552|BG004|Baseline|Part A, Cohort 2, Sequence 2|"Healthy participants received a single oral dose of the following:~Period 1: 15 mg LY2922083 Period 2: Placebo Period 3: 150 mg LY2922083"
11129154|NCT01748552|BG005|Baseline|Part A, Cohort 2, Sequence 3|"Healthy participants received a single oral dose of the following:~Period 1: 15 mg LY2922083 Period 2: 50 mg LY2922083 Period 3: Placebo"
11129155|NCT01748552|BG006|Baseline|Part A, Cohort 3, Sequence 1|"Healthy participants received a single oral dose of the following:~Period 1: Placebo Period 2: 845 mg LY2922083"
11129156|NCT01748552|BG007|Baseline|Part A, Cohort 3, Sequence 2|"Healthy participants received a single oral dose of the following:~Period 1: 450 mg LY2922083 Period 2: Placebo"
11129157|NCT01748552|BG008|Baseline|Part A, Cohort 3, Sequence 3|"Healthy participants received a single oral dose of the following:~Period 1: 450 mg LY2922083 Period 2: 845 mg LY2922083"
11129158|NCT01748552|BG009|Baseline|Part B, Cohort 1, Sequence 1|"Participants with T2DM received a single oral dose of the following:~Period 1: Placebo Period 2: 450 mg LY2922083 Period 3: 845 mg LY2922083"
11129159|NCT01748552|BG010|Baseline|Part B, Cohort 1, Sequence 2|"Participants with T2DM received a single oral dose of the following:~Period 1: 150 mg LY2922083 Period 2: Placebo Period 3: 845 mg LY2922083"
11129160|NCT01748552|BG011|Baseline|Part B, Cohort 1, Sequence 3|"Participants with T2DM received a single oral dose of the following:~Period 1: 150 mg LY2922083 Period 2: 450 mg LY2922083 Period 3: Placebo"
11129161|NCT01748552|BG012|Baseline|Total|Total of all reporting groups
11129162|NCT01748552|FG000|Participant Flow|Part A, Cohort 1, Sequence 1|"Healthy participants received a single oral dose of the following:~Period 1: Placebo~Period 2: 1.5 milligrams (mg) LY2922083~Period 3: 5 mg LY2922083"
11129163|NCT01748552|FG001|Participant Flow|Part A, Cohort 1, Sequence 2|"Healthy participants received a single oral dose of the following:~Period 1: 0.5 mg LY2922083~Period 2: Placebo~Period 3: 5 mg LY2922083"
11129164|NCT01748552|FG002|Participant Flow|Part A, Cohort 1, Sequence 3|"Healthy participants received a single oral dose of the following:~Period 1: 0.5 mg LY2922083~Period 2: 1.5 mg LY2922083~Period 3: Placebo"
11129165|NCT01748552|FG003|Participant Flow|Part A, Cohort 2, Sequence 1|"Healthy participants received a single oral dose of the following:~Period 1: Placebo~Period 2: 50 mg LY2922083~Period 3: 150 mg LY2922083"
11129166|NCT01748552|FG004|Participant Flow|Part A, Cohort 2, Sequence 2|"Healthy participants received a single oral dose of the following:~Period 1: 15 mg LY2922083~Period 2: Placebo~Period 3: 150 mg LY2922083"
11129167|NCT01748552|FG005|Participant Flow|Part A, Cohort 2, Sequence 3|"Healthy participants received a single oral dose of the following:~Period 1: 15 mg LY2922083~Period 2: 50 mg LY2922083~Period 3: Placebo"
11129168|NCT01748552|FG006|Participant Flow|Part A, Cohort 3, Sequence 1|"Healthy participants received a single oral dose of the following:~Period 1: Placebo~Period 2: 845 mg LY2922083"
11129169|NCT01748552|FG007|Participant Flow|Part A, Cohort 3, Sequence 2|"Healthy participants received a single oral dose of the following:~Period 1: 450 mg LY2922083~Period 2: Placebo"
11129170|NCT01748552|FG008|Participant Flow|Part A, Cohort 3, Sequence 3|"Healthy participants received a single oral dose of the following:~Period 1: 450 mg LY2922083~Period 2: 845 mg LY2922083"
11129171|NCT01748552|FG009|Participant Flow|Part B, Cohort 1, Sequence 1|"Participants with T2DM received a single oral dose of the following:~Period 1: Placebo~Period 2: 450 mg LY2922083~Period 3: 845 mg LY2922083"
11129172|NCT01748552|FG010|Participant Flow|Part B, Cohort 1, Sequence 2|"Participants with T2DM received a single oral dose of the following:~Period 1: 150 mg LY2922083~Period 2: Placebo~Period 3: 845 mg LY2922083"
11129173|NCT01748552|FG011|Participant Flow|Part B, Cohort 1, Sequence 3|"Participants with T2DM received a single oral dose of the following:~Period 1: 150 mg LY2922083~Period 2: 450 mg LY2922083~Period 3: Placebo"
11129174|NCT01748552|OG000|Outcome|Placebo (Parts A and B)|Healthy participants or participants with T2DM, in Part A or B, Cohorts 1, 2, or 3, who received a single oral dose of placebo in 1 of 3 study periods.
11129175|NCT01748552|OG001|Outcome|0.5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
11129176|NCT01748552|OG002|Outcome|1.5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
11129177|NCT01748552|OG003|Outcome|5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
11129178|NCT01748552|OG004|Outcome|15 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
11129179|NCT01748552|OG005|Outcome|50 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
11129180|NCT01748552|OG006|Outcome|150 mg LY2922083 (Parts A and B)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
11129181|NCT01748552|OG007|Outcome|450 mg LY2922083 (Parts A and B)|Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
11129182|NCT01748552|OG008|Outcome|845 mg LY2922083 (Parts A and B)|Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
11129183|NCT01748552|OG000|Outcome|0.5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
11129184|NCT01748552|OG001|Outcome|1.5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
11129185|NCT01748552|OG002|Outcome|5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
11129186|NCT01748552|OG003|Outcome|15 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
11129187|NCT01748552|OG004|Outcome|50 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
11129188|NCT01748552|OG005|Outcome|150 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3.
11129189|NCT01748552|OG006|Outcome|450 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1.
11129190|NCT01748552|OG007|Outcome|845 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2.
11129191|NCT01748552|OG008|Outcome|150 mg LY2922083 (Part B)|Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
11129192|NCT01748552|OG009|Outcome|450 mg LY2922083 (Part B)|Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
11129193|NCT01748552|OG010|Outcome|845 mg LY2922083 (Part B)|Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
11129194|NCT01748552|OG000|Outcome|Placebo (Part A)|Healthy participants in Part A, Cohorts 1, 2, or 3 who received a single oral dose of placebo in 1 of 3 study periods.
11129195|NCT01748552|OG006|Outcome|150 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3.
11129196|NCT01748552|OG007|Outcome|450 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1.
11129197|NCT01748552|OG008|Outcome|845 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2.
11129198|NCT01748552|OG009|Outcome|Placebo (Part B)|Participants with T2DM in Part B, Cohort 1 who received a single oral dose of placebo in 1 of 3 study periods.
11129199|NCT01748552|OG010|Outcome|150 mg LY2922083 (Part B)|Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
11129200|NCT01748552|OG011|Outcome|450 mg LY2922083 (Part B)|Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
11129201|NCT01748552|OG012|Outcome|845 mg LY2922083 (Part B)|Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
11129202|NCT01748552|OG009|Outcome|Placebo (Part B)|Participants with T2DM in Part B, Cohorts 1, 2, or 3 who received a single oral dose of placebo in 1 of 3 study periods.
11129203|NCT01748552|EG000|Reported Event|Placebo (Parts A and B)|Healthy participants or participants with T2DM, in Part A or B, Cohorts 1, 2, or 3, who received a single oral dose of placebo in 1 of 3 study periods.
11129204|NCT01748552|EG001|Reported Event|0.5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
11129205|NCT01748552|EG002|Reported Event|1.5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
11129206|NCT01748552|EG003|Reported Event|5 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
11129207|NCT01748552|EG004|Reported Event|15 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
11129208|NCT01748552|EG005|Reported Event|50 mg LY2922083 (Part A)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
11129209|NCT01748552|EG006|Reported Event|150 mg LY2922083 (Parts A and B)|Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
11129210|NCT01748552|EG007|Reported Event|450 mg LY2922083 (Parts A and B)|Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
11129211|NCT01748552|EG008|Reported Event|845 mg LY2922083 (Parts A and B)|Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
11129212|NCT01748643|BG000|Baseline|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
11129213|NCT01748643|BG001|Baseline|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
11129214|NCT01748643|BG002|Baseline|Total|Total of all reporting groups
11129215|NCT01748643|FG000|Participant Flow|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
11129216|NCT01748643|FG001|Participant Flow|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
11129217|NCT01748643|OG000|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
11129218|NCT01748643|OG001|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
11129219|NCT01748643|EG000|Reported Event|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
11129220|NCT01748643|EG001|Reported Event|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
11129221|NCT01748695|BG000|Baseline|V158866 and Placebo|Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa
11129222|NCT01748695|FG000|Participant Flow|Placebo Followed by V158866|Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
11129223|NCT01748695|FG001|Participant Flow|V158866 Followed by Placebo|V158866 450mg once per day for 4 weeks followed by placebo once per day for 4 weeks
11129224|NCT01748695|OG000|Outcome|Placebo|Placebo once per day for 4 weeks
11129225|NCT01748695|OG001|Outcome|V158866|V158866 450mg once per day for 4 weeks
11129226|NCT01748695|EG000|Reported Event|Placebo|Placebo once per day for 4 weeks
11129227|NCT01748695|EG001|Reported Event|V158866|V158866 450mg once per day for 4 Weeks
11129228|NCT01748760|BG000|Baseline|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
11129229|NCT01748760|BG001|Baseline|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
11129230|NCT01748760|BG002|Baseline|Total|Total of all reporting groups
11129231|NCT01748760|FG000|Participant Flow|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
11129232|NCT01748760|FG001|Participant Flow|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
11129233|NCT01748760|OG000|Outcome|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
11129234|NCT01748760|OG001|Outcome|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
11129235|NCT01748760|EG000|Reported Event|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
11129236|NCT01748760|EG001|Reported Event|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
11129237|NCT01748799|BG000|Baseline|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
11129238|NCT01748799|BG001|Baseline|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
11129239|NCT01748799|BG002|Baseline|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
11129240|NCT01748799|BG003|Baseline|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
11129241|NCT01748799|BG004|Baseline|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
11129242|NCT01748799|BG005|Baseline|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
11129243|NCT01748799|BG006|Baseline|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
11129244|NCT01748799|BG007|Baseline|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
11129245|NCT01748799|BG008|Baseline|Total|Total of all reporting groups
11129246|NCT01748799|FG000|Participant Flow|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
11129247|NCT01748799|FG001|Participant Flow|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
11129248|NCT01748799|FG002|Participant Flow|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
11129249|NCT01748799|FG003|Participant Flow|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
11129250|NCT01748799|FG004|Participant Flow|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
11129251|NCT01748799|FG005|Participant Flow|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
11129252|NCT01748799|FG006|Participant Flow|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
11129253|NCT01748799|FG007|Participant Flow|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
11129254|NCT01748799|OG000|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
11129255|NCT01748799|OG001|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
11129256|NCT01748799|OG002|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
11129257|NCT01748799|OG003|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
11129258|NCT01748799|OG004|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
11129259|NCT01748799|OG005|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
11129260|NCT01748799|OG006|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
11129261|NCT01748799|OG007|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
11129262|NCT01748799|OG000|Outcome|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
11129263|NCT01748799|OG001|Outcome|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
11129264|NCT01748799|OG002|Outcome|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
11129265|NCT01748799|OG003|Outcome|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
11129266|NCT01748799|OG004|Outcome|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and administer a fixed dose of placebo daily (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
11129267|NCT01748799|OG005|Outcome|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed Placebo
11129268|NCT01748799|OG006|Outcome|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
11129269|NCT01748799|OG007|Outcome|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated Placebo
11129270|NCT01748799|EG000|Reported Event|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
11129271|NCT01748799|EG001|Reported Event|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
11129272|NCT01748799|EG002|Reported Event|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
11129273|NCT01748799|EG003|Reported Event|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
11129274|NCT01748799|EG004|Reported Event|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and take a fixed dose of placebo during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
11129275|NCT01748799|EG005|Reported Event|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed placebo
11129276|NCT01748799|EG006|Reported Event|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
11129277|NCT01748799|EG007|Reported Event|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated placebo
11129278|NCT01748825|BG000|Baseline|ARM 1 AZD1775 200 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily
11129279|NCT01748825|BG001|Baseline|ARM 2 AZD1775 225 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily
11129280|NCT01748825|BG002|Baseline|ARM 3 AZD1775 225 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily
11129281|NCT01748825|BG003|Baseline|ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing)|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)
11129282|NCT01748825|BG004|Baseline|ARM 5 AZD1775 250 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily
11129283|NCT01748825|BG005|Baseline|ARM 6 AZD1775 300 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily
11129284|NCT01748825|BG006|Baseline|ARM 7 AZD1775 300 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily
11129285|NCT01748825|BG007|Baseline|ARM 8 AZD1775 400 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily
11129286|NCT01748825|BG008|Baseline|ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily
11129287|NCT01748825|BG009|Baseline|ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
11129288|NCT01748825|BG010|Baseline|Total|Total of all reporting groups
11129289|NCT01748825|FG000|Participant Flow|ARM 1 AZD1775 200 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily
11129290|NCT01748825|FG001|Participant Flow|ARM 2 AZD1775 225 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily
11129291|NCT01748825|FG002|Participant Flow|ARM 3 AZD1775 225 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily
11129292|NCT01748825|FG003|Participant Flow|ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing)|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)
11129293|NCT01748825|FG004|Participant Flow|ARM 5 AZD1775 250 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily
11129294|NCT01748825|FG005|Participant Flow|ARM 6 AZD1775 300 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily
11129295|NCT01748825|FG006|Participant Flow|ARM 7 AZD1775 300 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily
11129296|NCT01748825|FG007|Participant Flow|ARM 8 AZD1775 400 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily
11129297|NCT01748825|FG008|Participant Flow|ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily
11129298|NCT01748825|FG009|Participant Flow|ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
11129299|NCT01748825|OG000|Outcome|ARM 1 AZD1775 200 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily
11129300|NCT01748825|OG001|Outcome|ARM 2 AZD1775 225 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily
11129301|NCT01748825|OG002|Outcome|ARM 3 AZD1775 225 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily
11129302|NCT01748825|OG003|Outcome|ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing)|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)
11129303|NCT01748825|OG004|Outcome|ARM 5 AZD1775 250 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily
11129304|NCT01748825|OG005|Outcome|ARM 6 AZD1775 300 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily
11129305|NCT01748825|OG006|Outcome|ARM 7 AZD1775 300 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily
11129306|NCT01748825|OG007|Outcome|ARM 8 AZD1775 400 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily
11129307|NCT01748825|OG008|Outcome|ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily
11129308|NCT01748825|OG009|Outcome|ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
11129309|NCT01748825|OG000|Outcome|ARM 1 AZD1775 200 mg Once Daily|Participants received AZD1775 (MK-1775; adavosertib) by mouth at a starting dose of 200 mg once daily on cycle 1 days 1-5, during which the plasma concentrations of AZD1775 were evaluated.
11129310|NCT01748825|OG001|Outcome|ARM 2 AZD1775 225 mg Once Daily|Participants received AZD1775 (MK-1775; adavosertib) by mouth at a starting dose of 225 mg once daily on cycle 1 days 1-5, during which the plasma concentrations of AZD1775 were evaluated.
11129311|NCT01748825|OG002|Outcome|ARM 3 AZD1775 225 mg Twice Daily|Participants received AZD1775 (MK-1775; adavosertib) by mouth at a starting dose of 225 mg twice daily on cycle 1 days 1-2, during which the plasma concentrations of AZD1775 were evaluated.
11129312|NCT01748825|OG003|Outcome|ARM 5 AZD1775 250 mg Once Daily|Participants received AZD1775 (MK-1775; adavosertib) by mouth at a starting dose of 250 mg once daily on cycle 1 days 1-5, during which the plasma concentrations of AZD1775 were evaluated.
11129313|NCT01748825|OG004|Outcome|ARM 6 AZD1775 300 mg Once Daily|Participants received AZD1775 (MK-1775; adavosertib) by mouth at a starting dose of 300 mg once daily on cycle 1 days 1-5, during which the plasma concentrations of AZD1775 were evaluated.
11129314|NCT01748825|OG005|Outcome|ARM 7 AZD1775 300 mg Twice Daily|Participants received AZD1775 (MK-1775; adavosertib) by mouth at a starting dose of 300 mg twice daily on cycle 1 days 1-2, during which the plasma concentrations of AZD1775 were evaluated.
11129315|NCT01748825|OG006|Outcome|ARM 8 AZD1775 400 mg Once Daily|Participants received AZD1775 (MK-1775; adavosertib) by mouth at a starting dose of 400 mg once daily on cycle 1 days 1-5, during which the plasma concentrations of AZD1775 were evaluated.
11129316|NCT01748825|EG000|Reported Event|ARM 1 AZD1775 200 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily
11129317|NCT01748825|EG001|Reported Event|ARM 2 AZD1775 225 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily
11129318|NCT01748825|EG002|Reported Event|ARM 3 AZD1775 225 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily
11129319|NCT01748825|EG003|Reported Event|ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing)|Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)
11129320|NCT01748825|EG004|Reported Event|ARM 5 AZD1775 250 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily
11129321|NCT01748825|EG005|Reported Event|ARM 6 AZD1775 300 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily
11129322|NCT01748825|EG006|Reported Event|ARM 7 AZD1775 300 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily
11129323|NCT01748825|EG007|Reported Event|ARM 8 AZD1775 400 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily
11129324|NCT01748825|EG008|Reported Event|ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily|Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily
11129325|NCT01748825|EG009|Reported Event|ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily|Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
11129326|NCT01748916|BG000|Baseline|All Groups (Average)|All study participants
11129327|NCT01748916|FG000|Participant Flow|Papaya-Carrot-Tomato|"Test meals were consumed in the following order: 1. Papaya 2. Carrot 3. Tomato.~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
11129328|NCT01748916|FG001|Participant Flow|Papaya-Tomato-Carrot|"Test meals were consumed in the following order: 1. Papaya 2. Tomato 3. Carrot~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
11129329|NCT01748916|FG002|Participant Flow|Tomato-Papaya-Carrot|"Test meals were consumed in the following order: 1. Tomato 2. Papaya 3. Carrot~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
11129330|NCT01748916|FG003|Participant Flow|Tomato-Carrot-Papaya|"Test meals were consumed in the following order: 1. Tomato 2. Carrot 3. Papaya~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
11129331|NCT01748916|FG004|Participant Flow|Carrot-Papaya-Tomato|"Test meals were consumed in the following order: 1. Carrot 2. Papaya 3. Tomato~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
11129332|NCT01748916|FG005|Participant Flow|Carrot-Tomato-Papaya|"Test meals were consumed in the following order: 1. Carrot 2. Tomato 3. Papaya~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
11129333|NCT01748916|OG000|Outcome|Beta-Carotene Absorption From Papaya|
11129334|NCT01748916|OG001|Outcome|Beta-Carotene Absorption From Tomato|
11129335|NCT01748916|OG002|Outcome|Beta-Carotene Absorption From Carrot|
11129336|NCT01748916|OG003|Outcome|Lycopene Absorption From Papaya|
11129337|NCT01748916|OG004|Outcome|Lycopene Absorption From Tomato|
11129338|NCT01748916|EG000|Reported Event|All Groups|All groups in study
11129339|NCT01748942|BG000|Baseline|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
11129340|NCT01748942|BG001|Baseline|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
11129341|NCT01748942|BG002|Baseline|Total|Total of all reporting groups
11129342|NCT01748942|FG000|Participant Flow|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
11129343|NCT01748942|FG001|Participant Flow|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
11129344|NCT01748942|OG000|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
11129345|NCT01748942|OG001|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
11129346|NCT01748942|EG000|Reported Event|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
11129347|NCT01748942|EG001|Reported Event|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
11129348|NCT01748955|BG000|Baseline|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
11129349|NCT01748955|BG001|Baseline|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
11129350|NCT01748955|BG002|Baseline|Total|Total of all reporting groups
11129351|NCT01748955|FG000|Participant Flow|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
11129352|NCT01748955|FG001|Participant Flow|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
11129353|NCT01748955|OG000|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
11129354|NCT01748955|OG001|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
11129355|NCT01748955|EG000|Reported Event|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
11129356|NCT01748955|EG001|Reported Event|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
11129357|NCT01748994|BG000|Baseline|Placebo|"Administration of placebo to upper- and lower-body obese women~Placebo"
11129358|NCT01748994|BG001|Baseline|Drug|"Administration of pioglitazone to upper- and lower-body obese women~Pioglitazone: 30mg per day for four months"
11129359|NCT01748994|BG002|Baseline|Total|Total of all reporting groups
11129360|NCT01748994|FG000|Participant Flow|Placebo|"Administration of placebo to upper- and lower-body obese women~Placebo"
11129361|NCT01748994|FG001|Participant Flow|Drug|"Administration of pioglitazone to upper- and lower-body obese women~Pioglitazone: 30mg per day for four months"
11129362|NCT01748994|OG000|Outcome|Placebo|Placebo
11129363|NCT01748994|OG001|Outcome|Drug|Pioglitazone
11129364|NCT01748994|EG000|Reported Event|Placebo|"Administration of placebo to upper- and lower-body obese women~Placebo"
11129365|NCT01748994|EG001|Reported Event|Drug|"Administration of pioglitazone to upper- and lower-body obese women~Pioglitazone: 30mg per day for four months"
11129366|NCT01749033|BG000|Baseline|Group 1 Classic|"Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.~Group 1 Classic: Active Comparator: Group 1 classic~Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual."
11129367|NCT01749033|BG001|Baseline|Group 2 Pre Inflated|"Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer~Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer."
11129368|NCT01749033|BG002|Baseline|Group 3 ELL-PIC Technique|"Group 3 (ELL-PIC): Using the ELL-PIC technique.~Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique"
11129369|NCT01749033|BG003|Baseline|Total|Total of all reporting groups
11129370|NCT01749033|FG000|Participant Flow|Group 1 Classic|"Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.~Group 1 Classic: Active Comparator: Group 1 classic~Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual."
11129371|NCT01749033|FG001|Participant Flow|Group 2 Pre Inflated|"Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer~Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer."
11129372|NCT01749033|FG002|Participant Flow|Group 3 ELL-PIC Technique|"Group 3 (ELL-PIC): Using the ELL-PIC technique.~Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique"
11129373|NCT01749033|OG000|Outcome|Group 1 Classic|"Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.~Group 1 Classic: Active Comparator: Group 1 classic~Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual."
11129374|NCT01749033|OG001|Outcome|Group 2 Pre Inflated|"Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer~Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer."
11129375|NCT01749033|OG002|Outcome|Group 3 ELL-PIC Technique|"Group 3 (ELL-PIC): Using the ELL-PIC technique.~Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique"
11129376|NCT01749033|OG002|Outcome|Group 3 ELL-PIC Technique|"Group 3 (ELL-PIC): Using the ELL-PIC technique.~Group 3 ELL-PIC Group 3 (ELL-PIC): Using the ELL-PICtechnique"
11129377|NCT01749033|EG000|Reported Event|Group 1 Classic|"Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.~Group 1 Classic: Active Comparator: Group 1 classic~Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual."
11129378|NCT01749033|EG001|Reported Event|Group 2 Pre Inflated|"Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer~Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer."
11129379|NCT01749033|EG002|Reported Event|Group 3 ELLIA Technique|"Group 3 (ELLIA): Using the ELLIA technique.~Group 3 ELLIA: Group 3 (ELLIA): Using the ELLIA technique"
11129380|NCT01749215|BG000|Baseline|Topiramate|"Topiramate capsules daily - up to 300 mg~Topiramate: Experimental study drug~Medical Management: Brief alcohol counseling"
11129381|NCT01749215|BG001|Baseline|Placebo|"Placebo capsules daily - up to 300 mg~placebo: Placebo comparator~Medical Management: Brief alcohol counseling"
11129382|NCT01749215|BG002|Baseline|Total|Total of all reporting groups
11129383|NCT01749215|FG000|Participant Flow|Topiramate|"Topiramate capsules daily - up to 300 mg~Topiramate: Experimental study drug~Medical Management: Brief alcohol counseling"
11129384|NCT01749215|FG001|Participant Flow|Placebo|"Placebo capsules daily - up to 300 mg~placebo: Placebo comparator~Medical Management: Brief alcohol counseling"
11129385|NCT01749215|OG000|Outcome|Topiramate|"Topiramate capsules daily - up to 300 mg~Topiramate: Experimental study drug~Medical Management: Brief alcohol counseling"
11129386|NCT01749215|OG001|Outcome|Placebo|"Placebo capsules daily - up to 300 mg~placebo: Placebo comparator~Medical Management: Brief alcohol counseling"
11129387|NCT01749215|EG000|Reported Event|Topiramate|"Topiramate capsules daily - up to 300 mg~Topiramate: Experimental study drug~Medical Management: Brief alcohol counseling"
11129388|NCT01749215|EG001|Reported Event|Placebo|"Placebo capsules daily - up to 300 mg~placebo: Placebo comparator~Medical Management: Brief alcohol counseling"
11129389|NCT01749293|BG000|Baseline|Haploidentical Transplant|"All subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.~Fludarabine: Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3.~Busulfan: Subjects in this trial will receive Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3.~Total Body Irradiation: Subjects in this trial"
11129390|NCT01749293|FG000|Participant Flow|Haploidentical Transplant|"All subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.~Fludarabine: Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3.~Busulfan: Subjects in this trial will receive Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3.~Total Body Irradiation: Subjects in this trial will receive total body irradiation (2Gy fractionated) from Day -2 or -1.~Cyclophosphamide: Subjects in this trial will receive Cyclophosphamide 50 mg/kg IV QD on Days 3 and 4 post-transplant."
11129391|NCT01749293|OG000|Outcome|Haploidentical Transplant|"All subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.~Fludarabine: Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3.~Busulfan: Subjects in this trial will receive Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3.~Total Body Irradiation: Subjects in this trial will receive total body irradiation (2Gy fractionated) from Day -2 or -1.~Cyclophosphamide: Subjects in this trial will receive Cyclophosphamide 50 mg/kg IV QD on Days 3 and 4 post-transplant."
11129392|NCT01749293|OG000|Outcome|Haploidentical Transplant|"All subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.~Haploidentical Transplant: Subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.~Fludarabine: Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3.~Busulfan: Subjects in this trial will receive Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3.~Total Body Irradiation: Subjects in this trial"
11129393|NCT01749293|EG000|Reported Event|Haploidentical Transplant|"All subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.~Fludarabine: Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3.~Busulfan: Subjects in this trial will receive Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3.~Total Body Irradiation: Subjects in this trial will receive total body irradiation (2Gy fractionated) from Day -2 or -1.~Cyclophosphamide: Subjects in this trial will receive Cyclophosphamide 50 mg/kg IV QD on Days 3 and 4 post-transplant."
11129394|NCT01749410|BG000|Baseline|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
11129395|NCT01749410|FG000|Participant Flow|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
11129396|NCT01749410|OG000|Outcome|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
11129397|NCT01749410|EG000|Reported Event|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
11129398|NCT01749501|BG000|Baseline|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
11129399|NCT01749501|BG001|Baseline|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
11129400|NCT01749501|BG002|Baseline|Total|Total of all reporting groups
11129401|NCT01749501|FG000|Participant Flow|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
11129402|NCT01749501|FG001|Participant Flow|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
11129403|NCT01749501|OG000|Outcome|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
11129404|NCT01749501|OG001|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
11129405|NCT01749501|EG000|Reported Event|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
11129406|NCT01749501|EG001|Reported Event|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
11129407|NCT01749605|BG000|Baseline|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
11129408|NCT01749605|BG001|Baseline|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
11129409|NCT01749605|BG002|Baseline|Total|Total of all reporting groups
11129410|NCT01749605|FG000|Participant Flow|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
11129411|NCT01749605|FG001|Participant Flow|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
11129412|NCT01749605|OG000|Outcome|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
11129413|NCT01749605|OG001|Outcome|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
11129414|NCT01749605|EG000|Reported Event|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
11129415|NCT01749605|EG001|Reported Event|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
11129416|NCT01749631|BG000|Baseline|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
11129417|NCT01749631|FG000|Participant Flow|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
11129418|NCT01749631|OG000|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
11129419|NCT01749631|EG000|Reported Event|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
11129420|NCT01749735|BG000|Baseline|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
11129421|NCT01749735|BG001|Baseline|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
11129422|NCT01749735|BG002|Baseline|Total|Total of all reporting groups
11129423|NCT01749735|FG000|Participant Flow|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
11129424|NCT01749735|FG001|Participant Flow|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
11129425|NCT01749735|OG000|Outcome|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
11129426|NCT01749735|OG001|Outcome|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
11129427|NCT01749735|EG000|Reported Event|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
11129428|NCT01749735|EG001|Reported Event|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
11129429|NCT01749800|BG000|Baseline|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
11129430|NCT01749800|BG001|Baseline|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
11342019|NCT03695094|BG001|Baseline|Group 2 (Neutral [Control])|Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
11342020|NCT03695094|BG002|Baseline|Total Title|
11129431|NCT01749800|BG002|Baseline|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
11129432|NCT01749800|BG003|Baseline|Total|Total of all reporting groups
11129433|NCT01749800|FG000|Participant Flow|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
11129434|NCT01749800|FG001|Participant Flow|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
11129435|NCT01749800|FG002|Participant Flow|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
11129436|NCT01749800|OG000|Outcome|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
11129437|NCT01749800|OG001|Outcome|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
11129438|NCT01749800|OG002|Outcome|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
11129439|NCT01749800|EG000|Reported Event|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
11129440|NCT01749800|EG001|Reported Event|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
11129441|NCT01749800|EG002|Reported Event|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
11129442|NCT01749904|BG000|Baseline|BOL-303259-X|BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye during the efficacy phase, and for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
11129443|NCT01749904|BG001|Baseline|Timolol|Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye. thereafter these subjects were switched to receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
11129444|NCT01749904|BG002|Baseline|Total|Total of all reporting groups
11129445|NCT01749904|FG000|Participant Flow|BOL-303259-X|"BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).~BOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).~BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)"
11129446|NCT01749904|FG001|Participant Flow|Timolol|"Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).~Timolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)~BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)"
11129447|NCT01749904|OG000|Outcome|BOL-303259-X|"BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).~BOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).~BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)"
11129448|NCT01749904|OG001|Outcome|Timolol|"Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).~Timolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)~BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)"
11129449|NCT01749904|OG000|Outcome|BOL-303259-X|BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase.
11129450|NCT01749904|OG001|Outcome|Timolol|Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase.
11129451|NCT01749904|OG002|Outcome|BOL-303259-X Safety Extension Phase|Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
11129452|NCT01749904|EG000|Reported Event|BOL-303259-X|BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase.
11129453|NCT01749904|EG001|Reported Event|Timolol|Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase.
11129454|NCT01749904|EG002|Reported Event|BOL-303259-X Safety Extension Phase|Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
11129455|NCT01749930|BG000|Baseline|BOL-303259-X|"BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).~BOL-303259-X: BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning~BOL-303259-X: All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7)."
11129456|NCT01749930|BG001|Baseline|Timolol|"Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).~Timolol: Timolol will be administered BID once in the morning and once in the evening.~BOL-303259-X: All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7)."
11129457|NCT01749930|BG002|Baseline|Total|Total of all reporting groups
11129458|NCT01749930|FG000|Participant Flow|BOL-303259-X|"BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).~BOL-303259-X: BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning~BOL-303259-X: All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7)."
11129459|NCT01749930|FG001|Participant Flow|Timolol|"Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).~Timolol: Timolol will be administered BID once in the morning and once in the evening.~BOL-303259-X: All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7)."
11129460|NCT01749930|OG000|Outcome|BOL-303259-X|BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye.
11129461|NCT01749930|OG001|Outcome|Timolol|Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye.
11129462|NCT01749930|OG000|Outcome|BOL-303259-X|BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase
11129463|NCT01749930|OG001|Outcome|Timolol|Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase
11129464|NCT01749930|OG002|Outcome|BOL-303259-X Safety Extension Phase|Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 3 months during the open label safety extension phase
11226838|NCT02378402|EG002|Reported Event|Control Group|"Age- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11129465|NCT01749930|EG000|Reported Event|BOL-303259-X|BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase
11129466|NCT01749930|EG001|Reported Event|Timolol|Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase.
11129467|NCT01749930|EG002|Reported Event|BOL-303259-X Safety Extension Phase|Following completion of the efficacy phase, all subjects were converted to BL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 3 months during the open label extension phase
11129468|NCT01749956|BG000|Baseline|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
11129469|NCT01749956|FG000|Participant Flow|FOLFOX6/Aflibercept/Radation/Surgery|"Preoperative Chemoradiation (6 weeks): 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IV), Days 1-42; Radiation: 50.4 Gy (1.8 Gy/day) Mon-Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.~Surgery (6 weeks from last dose of aflibercep): abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.~Postoperative Chemotherapy and Aflibercept: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour; Days 1 and 15 of each 28-day cycle; Modified FOLFOX6: Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle."
11129470|NCT01749956|OG000|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
11129471|NCT01749956|OG000|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
11129472|NCT01749956|EG000|Reported Event|FOLFOX6/Aflibercept/Radiation/Surgery|"Preoperative Chemoradiation: 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.~Surgery: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.~Postoperative Chemotherapy and Aflibercept Treatments:~Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle.~Modified FOLFOX6:~Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.~Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.~5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.~Radiation~Aflibercept~Surgery: Abdominoperineal or low anterior resectio"
11129473|NCT01749982|BG000|Baseline|Placebo|"Placebo tablets~Placebo"
11129474|NCT01749982|BG001|Baseline|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
11129475|NCT01749982|BG002|Baseline|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
11129476|NCT01749982|BG003|Baseline|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
11129477|NCT01749982|BG004|Baseline|Total|Total of all reporting groups
11129478|NCT01749982|FG000|Participant Flow|Placebo|"Placebo tablets~Placebo"
11129479|NCT01749982|FG001|Participant Flow|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
11129480|NCT01749982|FG002|Participant Flow|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
11129481|NCT01749982|FG003|Participant Flow|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
11129482|NCT01749982|OG000|Outcome|Placebo|"Placebo tablets~Placebo"
11129483|NCT01749982|OG001|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
11129484|NCT01749982|OG002|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
11129485|NCT01749982|OG003|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
11129486|NCT01749982|EG000|Reported Event|Placebo|"Placebo tablets~Placebo"
11129487|NCT01749982|EG001|Reported Event|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
11129488|NCT01749982|EG002|Reported Event|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
11129489|NCT01749982|EG003|Reported Event|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
11129490|NCT01749995|BG000|Baseline|Cohort|Older patients with cancer receiving a full CGA
11129491|NCT01749995|FG000|Participant Flow|Cohort|Older patients with cancer receiving a full CGA
11129492|NCT01749995|OG000|Outcome|Cohort|Older patients with cancer receiving a full CGA
11129493|NCT01749995|EG000|Reported Event|Cohort|Older patients with cancer receiving a full CGA
11129494|NCT01750086|BG000|Baseline|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
11129495|NCT01750086|BG001|Baseline|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
11129496|NCT01750086|BG002|Baseline|Total|Total of all reporting groups
11226839|NCT02378480|BG000|Baseline|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 12 hours (q12h) (2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg oral administration q24h after a minimum of 3 days (6 doses) of IV treatment (6 overall IV doses because of the blinding). Participants received 4 active doses plus 2 placebo doses to maintain the blind. The total treatment duration was 7 to 14 days.
11129497|NCT01750086|FG000|Participant Flow|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
11129498|NCT01750086|FG001|Participant Flow|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
11129499|NCT01750086|OG000|Outcome|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
11129500|NCT01750086|OG001|Outcome|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
11129501|NCT01750086|EG000|Reported Event|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
11129502|NCT01750086|EG001|Reported Event|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
11226840|NCT02378480|BG001|Baseline|Linezolid|Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days.
11129503|NCT01750190|BG000|Baseline|Roxadustat|Participants received roxadustat tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat doses of 70 mg TIW to participants weighing <70 kg and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 234.9 weeks.
11129504|NCT01750190|BG001|Baseline|Placebo|Participants received roxadustat-matching placebo tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 208.1 weeks.
11129505|NCT01750190|BG002|Baseline|Total|Total of all reporting groups
11129506|NCT01750190|FG000|Participant Flow|Roxadustat|Participants received roxadustat tablets orally 3 times a week (TIW). The initial dose was according to the tiered weight-based approach, with starting roxadustat doses of 70 milligrams (mg) TIW to participants weighing <70 kilograms (kg) and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 grams/deciliter (g/dL) and Hb increase from baseline (BL) of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 234.9 weeks.
11129507|NCT01750190|FG001|Participant Flow|Placebo|Participants received roxadustat-matching placebo tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 208.1 weeks.
11129508|NCT01750190|OG000|Outcome|Roxadustat|Participants received roxadustat tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat doses of 70 mg TIW to participants weighing <70 kg and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 234.9 weeks.
11129509|NCT01750190|OG001|Outcome|Placebo|Participants received roxadustat-matching placebo tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 208.1 weeks.
11129510|NCT01750190|EG000|Reported Event|Roxadustat|Participants received roxadustat tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat doses of 70 mg TIW to participants weighing <70 kg and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 234.9 weeks.
11129511|NCT01750190|EG001|Reported Event|Placebo|Participants received roxadustat-matching placebo tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 208.1 weeks.
11129512|NCT01750229|BG000|Baseline|Randomized Phase Subjects|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129513|NCT01750229|FG000|Participant Flow|All Randomized Subjects|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129514|NCT01750229|OG000|Outcome|Sham|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129515|NCT01750229|OG001|Outcome|1200 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129516|NCT01750229|OG002|Outcome|3030 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129517|NCT01750229|OG003|Outcome|5882 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129518|NCT01750229|EG000|Reported Event|Sham|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129519|NCT01750229|EG001|Reported Event|1200 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129520|NCT01750229|EG002|Reported Event|3030 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129521|NCT01750229|EG003|Reported Event|5882 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
11129522|NCT01750242|BG000|Baseline|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
11129523|NCT01750242|FG000|Participant Flow|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus who consented for the study.
11129524|NCT01750242|OG000|Outcome|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus and with readable images.
11129525|NCT01750242|OG000|Outcome|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
11129526|NCT01750242|EG000|Reported Event|Subjects With Advanced Parkinson's Disease|The study protocol did not require safety data to be collected for the study.
11129527|NCT01750255|BG000|Baseline|Control|"There is no placebo treatment, and after randomization, patients were informed of their group assignments. The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.~Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families."
11129528|NCT01750255|BG001|Baseline|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment. Pharmaceutical Care: Patients and their families will be provided with verbal and written information and education about mental health and bipolar disorder.
11129529|NCT01750255|BG002|Baseline|Total|Total of all reporting groups
11129530|NCT01750255|FG000|Participant Flow|Control: Usual Care (Routine Dispensing), Verbal and Written|Because there is no blinding, there is no 'placebo' treatment. Patients who meet the inclusion criteria will be informed about the study and they will be registered after their signed authorization. The control group (patients and their families) will receive usual care as well as verbal and written information provided by the pharmacist (routine dispensing, including oral counseling regarding drugs). The written material is about mental health (MH) and BD, with information focusing on the importance of adhering to pharmacological and non-pharmacological interventions to achieve treatment goals. Randomization will take place during week zero (baseline) and patients will meet again with the pharmacist every three months (3, 6, 9, and 12 months). At each appointment, variables related to the primary (number of hospitalizations, emergency service consultations, unscheduled outpatient visits) and secondary outcomes (effectiveness, safety, adherence, and quality of life) will be assessed.
11129531|NCT01750255|FG001|Participant Flow|Intervention Group: the Dader Method for Pharmaceutical Care|The Dader Method for pharmaceutical care is a systematic process developed by the Research Group of Pharmaceutical Care at the University of Granada, Spain [16]. The intervention is based on the use of pharmacotherapy records, evaluation of an assessment form that includes BD-I and the drugs used to treat this medical problem, and their assessment on a specific date. This assessment is used to identify: (1) any potential or actual patient health outcomes that are not consistent with the objectives of pharmacotherapy and are associated with the use of medicines (negative outcomes associated with medication (NOM)); and (2) situations in which the use of medicines caused or may cause the appearance of a NOM (drug-related problems (DRP)) [14]. Once the relevant problems are identified, the necessary interventions to patients or to physicians are carried out to solve the identified NOM and are followed by a subsequent assessment of the achieved outcomes.
11226841|NCT02378480|BG002|Baseline|Total|Total of all reporting groups
11129532|NCT01750255|OG000|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
11129533|NCT01750255|OG001|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
11129534|NCT01750255|OG001|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
11129535|NCT01750255|EG000|Reported Event|Control|"The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.~Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure d"
11129536|NCT01750255|EG001|Reported Event|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
11129537|NCT01750268|BG000|Baseline|Topiramate|"Topiramate capsules daily - up to 300 mg~Medical Management Counseling: Brief alcohol and medication counseling~Topiramate: Experimental medication"
11129538|NCT01750268|BG001|Baseline|Placebo|"Placebo capsules daily - up 300 mg~Medical Management Counseling: Brief alcohol and medication counseling~Placebo: Placebo comparator"
11129539|NCT01750268|BG002|Baseline|Total|Total of all reporting groups
11129540|NCT01750268|FG000|Participant Flow|Topiramate|"Topiramate capsules daily - up to 300 mg~Medical Management Counseling: Brief alcohol and medication counseling~Topiramate: Experimental medication"
11129541|NCT01750268|FG001|Participant Flow|Placebo|"Placebo capsules daily - up 300 mg~Medical Management Counseling: Brief alcohol and medication counseling~Placebo: Placebo comparator"
11129542|NCT01750268|OG000|Outcome|Topiramate|"Topiramate capsules daily - up to 300 mg~Medical Management Counseling: Brief alcohol and medication counseling~Topiramate: Experimental medication"
11129543|NCT01750268|OG001|Outcome|Placebo|"Placebo capsules daily - up 300 mg~Medical Management Counseling: Brief alcohol and medication counseling~Placebo: Placebo comparator"
11129544|NCT01750268|EG000|Reported Event|Topiramate|"Topiramate capsules daily - up to 300 mg~Medical Management Counseling: Brief alcohol and medication counseling~Topiramate: Experimental medication"
11129545|NCT01750268|EG001|Reported Event|Placebo|"Placebo capsules daily - up 300 mg~Medical Management Counseling: Brief alcohol and medication counseling~Placebo: Placebo comparator"
11129546|NCT01750294|BG000|Baseline|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
11129547|NCT01750294|FG000|Participant Flow|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
11129548|NCT01750294|OG000|Outcome|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
11129549|NCT01750294|EG000|Reported Event|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
11129550|NCT01750346|BG000|Baseline|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
11129551|NCT01750346|BG001|Baseline|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
11129552|NCT01750346|BG002|Baseline|Placebo|Participants in the Placebo arm received the placebo.
11129553|NCT01750346|BG003|Baseline|Total|Total of all reporting groups
11129554|NCT01750346|FG000|Participant Flow|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
11129555|NCT01750346|FG001|Participant Flow|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
11129556|NCT01750346|FG002|Participant Flow|Placebo|Participants in the Placebo arm received the placebo.
11129557|NCT01750346|OG000|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
11129558|NCT01750346|OG001|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
11129559|NCT01750346|OG002|Outcome|Placebo|Participants in the Placebo arm received the placebo.
11129560|NCT01750346|EG000|Reported Event|0.05% AH-8|"Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.~Topical acetyl hexapeptide-8"
11129561|NCT01750346|EG001|Reported Event|0.025% AH-8|"Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.~Topical acetyl hexapeptide-8"
11129562|NCT01750346|EG002|Reported Event|Placebo|"Participants in the Placebo arm received the placebo.~Topical acetyl hexapeptide-8"
11129563|NCT01750398|BG000|Baseline|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial lead-in castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
11129564|NCT01750398|FG000|Participant Flow|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial lead-in castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
11129565|NCT01750398|OG000|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial lead-in castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
11129566|NCT01750398|EG000|Reported Event|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial lead-in castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
11129567|NCT01750502|BG000|Baseline|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
11129568|NCT01750502|BG001|Baseline|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
11129569|NCT01750502|BG002|Baseline|Total|Total of all reporting groups
11129570|NCT01750502|FG000|Participant Flow|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
11129571|NCT01750502|FG001|Participant Flow|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
11129572|NCT01750502|OG000|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
11129573|NCT01750502|OG001|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
11129574|NCT01750502|OG000|Outcome|Before Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
11129575|NCT01750502|OG001|Outcome|After Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
11129576|NCT01750502|OG002|Outcome|5 Minutes After the Opening of the Balloon|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
11129577|NCT01750502|OG000|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
11129578|NCT01750502|OG001|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
11129579|NCT01750502|EG000|Reported Event|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
11129580|NCT01750502|EG001|Reported Event|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
11129581|NCT01750684|BG000|Baseline|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
11129582|NCT01750684|BG001|Baseline|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
11129583|NCT01750684|BG002|Baseline|Total|Total of all reporting groups
11129584|NCT01750684|FG000|Participant Flow|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
11129585|NCT01750684|FG001|Participant Flow|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
11129586|NCT01750684|OG000|Outcome|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
11129587|NCT01750684|OG001|Outcome|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
10849018|NCT00293254|EG000|Reported Event|Raltegravir 400 mg b.i.d. Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who~continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
11129588|NCT01750684|OG000|Outcome|Saline|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
11129589|NCT01750684|EG000|Reported Event|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
11129590|NCT01750684|EG001|Reported Event|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
11129591|NCT01750697|BG000|Baseline|Rituximab|Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))
11129592|NCT01750697|FG000|Participant Flow|Rituximab|Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))
11129593|NCT01750697|OG000|Outcome|Remission Induction Phase (up to 6 Mos.) Rituximab|Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per metre squared (mg/m^2) once a week on Days 1, 8, 15 and 22 during Remission Induction Phase (Day 1 (baseline) to Month 6)
11129594|NCT01750697|OG001|Outcome|Overall Follow-up Phase (up to 4.5 Yrs) Rituximab|Participants who received rituximab during the Remission Induction Phase were followed for a minimum of 18 months during the Follow-up Phase and could receive additional rituximab or other treatments for GPA/MPA (Day 1 (baseline) up to 4.5 yrs)
11129595|NCT01750697|OG000|Outcome|Rituximab (Experimental)|Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))
11129596|NCT01750697|EG000|Reported Event|Remission Induction Phase: Rituximab|Participants received rituximab as an IV infusion of 375 mg/m^2 once a week on Days 1, 8, 15 and 22 during Remission Induction Phase (Day 1 (baseline) to Month 6)
11129597|NCT01750697|EG001|Reported Event|Overall Follow-up Phase: Rituximab|Participants who received rituximab during the remission induction phase were followed for a minimum of 18 months during the follow-up phase and could receive additional rituximab or other treatments for GPA/MPA (Day 1 (baseline) up to 4.5 yrs)
11129598|NCT01750840|BG000|Baseline|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
11129599|NCT01750840|FG000|Participant Flow|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
11129600|NCT01750840|OG000|Outcome|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
11129601|NCT01750840|OG000|Outcome|Stimulation Group|"All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.~Biomet EBI Bone Healing System: A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.~Biomet Orthopak Non-Invasive Bone Growth Stimulator: A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.~Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System: A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day."
11129602|NCT01750840|EG000|Reported Event|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
11129603|NCT01750879|BG000|Baseline|Active|Participants will be randomly assigned by study statistician to treatment or placebo groups at a ratio of 3:1 following a double-blind placebo controlled food challenge, DBPCFC1, on 2 separate days. One challenge will consist of 5 doses of peanut in increasing amounts up to a total of 443 mg of peanut protein masked in vehicle food. The second day will consist of placebo material given similarly. Participants with an eliciting dose of 443mg or less will receive daily escalating dosages of peanut flour OIT in a blinded fashion, as described in the modified rush phase, until a daily dose of 4000 mg is reached. Following treatment, a 2nd challenge will occur DBPCFC2, identical to DBPCFC1, but with additional doses of 1000 mg and 3000 mg for a cumulative dose of 4443 mg peanut protein. After 12 weeks of complete peanut avoidance, participants will undergo a third challenge, DBPCFC3, which will follow a slightly different schedule of doses for a cumulative dose of 4430 mg peanut protein.
11129604|NCT01750879|BG001|Baseline|Placebo|Participants in the placebo arm will follow the same protocol except they receive daily escalating dosages of placebo oat flour, and they will not participate in DBPCFC3. Following DBPCFC2, assignment will be unblinded and placebo participants will be offered open-label active treatment under a separate protocol.
11129605|NCT01750879|BG002|Baseline|Total|Total of all reporting groups
11129606|NCT01750879|FG000|Participant Flow|Peanut Flour|Participants will be randomly assigned by study statistician to treatment or placebo groups at a ratio of 3:1 following a double-blind placebo controlled food challenge, DBPCFC1, on 2 separate days. One challenge will consist of 5 doses of peanut in increasing amounts up to a total of 443 mg of peanut protein masked in vehicle food. The second day will consist of placebo material given similarly. Participants with an eliciting dose of 443mg or less will receive daily escalating dosages of peanut flour OIT in a blinded fashion, as described in the modified rush phase, until a daily dose of 4000 mg is reached. Following treatment, a 2nd challenge will occur DBPCFC2, identical to DBPCFC1, but with additional doses of 1000 mg and 3000 mg for a cumulative dose of 4443 mg peanut protein. After 12 weeks of complete peanut avoidance, participants will undergo a third challenge, DBPCFC3, which will follow a slightly different schedule of doses for a cumulative dose of 4430 mg peanut protein.
11129607|NCT01750879|FG001|Participant Flow|Placebo (Oat) Flour|Participants in the placebo arm will follow the same protocol except they receive daily escalating dosages of placebo oat flour, and they will not participate in DBPCFC3. Following DBPCFC2, assignment will be unblinded and placebo participants will be offered open-label active treatment under a separate protocol.
11129608|NCT01750879|OG000|Outcome|Active|Participants will be randomly assigned by study statistician to treatment or placebo groups at a ratio of 3:1 following a double-blind placebo controlled food challenge, DBPCFC1, on 2 separate days. One challenge will consist of 5 doses of peanut in increasing amounts up to a total of 443 mg of peanut protein masked in vehicle food. The second day will consist of placebo material given similarly. Participants with an eliciting dose of 443mg or less will receive daily escalating dosages of peanut flour OIT in a blinded fashion, as described in the modified rush phase, until a daily dose of 4000 mg is reached. Following treatment, a 2nd challenge will occur DBPCFC2, identical to DBPCFC1, but with additional doses of 1000 mg and 3000 mg for a cumulative dose of 4443 mg peanut protein. After 12 weeks of complete peanut avoidance, participants will undergo a third challenge, DBPCFC3, which will follow a slightly different schedule of doses for a cumulative dose of 4430 mg peanut protein.
11129609|NCT01750879|OG001|Outcome|Placebo|Participants in the placebo arm will follow the same protocol except they receive daily escalating dosages of placebo oat flour, and they will not participate in DBPCFC3. Following DBPCFC2, assignment will be unblinded and placebo participants will be offered open-label active treatment under a separate protocol.
11129610|NCT01750879|OG000|Outcome|Peanut Flour|Participants will be randomly assigned by study statistician to treatment or placebo groups at a ratio of 3:1 following a double-blind placebo controlled food challenge, DBPCFC1, on 2 separate days. One challenge will consist of 5 doses of peanut in increasing amounts up to a total of 443 mg of peanut protein masked in vehicle food. The second day will consist of placebo material given similarly. Participants with an eliciting dose of 443mg or less will receive daily escalating dosages of peanut flour OIT in a blinded fashion, as described in the modified rush phase, until a daily dose of 4000 mg is reached. Following treatment, a 2nd challenge will occur DBPCFC2, identical to DBPCFC1, but with additional doses of 1000 mg and 3000 mg for a cumulative dose of 4443 mg peanut protein. After 12 weeks of complete peanut avoidance, participants will undergo a third challenge, DBPCFC3, which will follow a slightly different schedule of doses for a cumulative dose of 4430 mg peanut protein.
11129611|NCT01750879|OG001|Outcome|Placebo (Oat) Flour|Participants in the placebo arm will follow the same protocol except they receive daily escalating dosages of placebo oat flour, and they will not participate in DBPCFC3. Following DBPCFC2, assignment will be unblinded and placebo participants will be offered open-label active treatment under a separate protocol.
11129612|NCT01750879|OG000|Outcome|Peanut Flour -- Tolerance|Tolerance: Ingestion of 4430 mg of peanut protein at DBPCFC3 without symptoms.
11129613|NCT01750879|OG001|Outcome|Peanut Flour -- Partial Tolerance|Partial Tolerance: ED at DBPCFC3 <4430 mg but ≥430 mg AND >10-fold more than at DBPCFC1.
11129614|NCT01750879|OG002|Outcome|Peanut Flour -- Treatment Failure|Treatment Failure: Inability to tolerate the minimum maintenance dose (600 mg) of peanut protein by 12 months, or an ED <1443 mg at DBPCFC2, or ED at DBPCFC3 <443 mg OR <10-fold more than at DBPCFC1
11129615|NCT01750879|OG003|Outcome|Placebo|Placebo (Oat Flour) treated participants.
11129616|NCT01750879|OG000|Outcome|Peanut Flour - Tolerance|Tolerance: Ingestion of 4430 mg of peanut protein at DBPCFC3 without symptoms.
11129617|NCT01750879|OG001|Outcome|Peanut Flour - Treatment Failure|Treatment Failure: Inability to tolerate the minimum maintenance dose (600 mg) of peanut protein by 12 months, or an ED <1443 mg at DBPCFC2, or ED at DBPCFC3 <443 mg OR <10-fold more than at DBPCFC1.
11129618|NCT01750879|OG002|Outcome|Peanut Flour - Partial Tolerance|Partial Tolerance: ED at DBPCFC3 <4430 mg but ≥430 mg AND >10-fold more than at DBPCFC1.
11129619|NCT01750879|OG003|Outcome|Placebo - Treatment Failure|Received oat flour (placebo) treatment. All treatment failures; 3 due to early withdraw, 8 by DBPCFC2 outcome. Per protocol, none advanced to DBPCFC3.
11129620|NCT01750879|EG000|Reported Event|Peanut Flour|"Oral Immunotherapy with peanut flour.~Peanut Flour: Peanut Flour"
11129621|NCT01750879|EG001|Reported Event|Oat Flour|"Oral Immunotherapy with oat flour.~Oat Flour: Oat Flour"
11129622|NCT01750918|BG000|Baseline|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 4.8MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 1.5 mg QD + Panitumumab 4.8 mg/kg Q2W
11129623|NCT01750918|BG001|Baseline|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129624|NCT01750918|BG002|Baseline|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129625|NCT01750918|BG003|Baseline|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 6MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129626|NCT01750918|BG004|Baseline|Part 4A+4B - Double Combination (T+P) mBRAF: TRA 2MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) mBRAF Patients: Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129627|NCT01750918|BG005|Baseline|Part 4A+4B - Double Combination (T+P) mBRAF: TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) mBRAF Patients: Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129628|NCT01750918|BG006|Baseline|Part 4A+4B - Double Combination (T+P) mBRAF: TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) mBRAF Patients: Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129629|NCT01750918|BG007|Baseline|Part 4A+4B - Double Combination (T+P) Anti-EGFR: TRA 2MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) anti-EGFR Patients: Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129630|NCT01750918|BG008|Baseline|Part 4A+4B - Double Combination (T+P) Anti-EGFR: TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) anti-EGFR Patients: Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129631|NCT01750918|BG009|Baseline|Part 4A+4B - Double Combination (T+P) Anti-EGFR: TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) anti-EGFR: Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129632|NCT01750918|BG010|Baseline|Part 1+2A - Double Combination (D+P): DAB 150MG BID, PAN 6MG/KG Q2W|Part 1+2A - Double combination (Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Panitumumab 6.0 mg/kg Q2W
11129633|NCT01750918|BG011|Baseline|Total|Total of all reporting groups
11129634|NCT01750918|FG000|Participant Flow|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 4.8MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 1.5 mg QD + Panitumumab 4.8 mg/kg Q2W
11129635|NCT01750918|FG001|Participant Flow|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129636|NCT01750918|FG002|Participant Flow|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129637|NCT01750918|FG003|Participant Flow|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 6MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129638|NCT01750918|FG004|Participant Flow|Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129639|NCT01750918|FG005|Participant Flow|Part 4A+4B - Double Combination (T+P): TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129640|NCT01750918|FG006|Participant Flow|Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129641|NCT01750918|FG007|Participant Flow|Part 1+2A - Double Combination (D+P): DAB 150MG BID, PAN 6MG/KG Q2W|Part 1+2A - Double combination (Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Panitumumab 6.0 mg/kg Q2W
11129642|NCT01750918|OG000|Outcome|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 4.8MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 1.5 mg QD + Panitumumab 4.8 mg/kg Q2W
11129643|NCT01750918|OG001|Outcome|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129644|NCT01750918|OG002|Outcome|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129645|NCT01750918|OG003|Outcome|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 6MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129646|NCT01750918|OG004|Outcome|Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129647|NCT01750918|OG005|Outcome|Part 4A+4B - Double Combination (T+P): TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129648|NCT01750918|OG006|Outcome|Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129649|NCT01750918|OG007|Outcome|Part 1+2A - Double Combination (D+P): DAB 150MG BID, PAN 6MG/KG Q2W|Part 1+2A - Double combination (Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Panitumumab 6.0 mg/kg Q2W
11129650|NCT01750918|OG004|Outcome|Part 4A+4B - Double Combination (T+P) mBRAF: TRA 2MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) mBRAF Patients: Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129651|NCT01750918|OG005|Outcome|Part 4A+4B - Double Combination (T+P) mBRAF: TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) mBRAF Patients: Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129652|NCT01750918|OG006|Outcome|Part 4A+4B - Double Combination (T+P) mBRAF: TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) mBRAF Patients: Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129653|NCT01750918|OG007|Outcome|Part 4A+4B - Double Combination (T+P) Anti-EGFR: TRA 2MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) anti-EGFR Patients: Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129654|NCT01750918|OG008|Outcome|Part 4A+4B - Double Combination (T+P) Anti-EGFR: TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) anti-EGFR Patients: Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129655|NCT01750918|OG009|Outcome|Part 4A+4B - Double Combination (T+P) Anti-EGFR: TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab) anti-EGFR: Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129656|NCT01750918|OG010|Outcome|Part 1+2A - Double Combination (D+P): DAB 150MG BID, PAN 6MG/KG Q2W|Part 1+2A - Double combination (Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Panitumumab 6.0 mg/kg Q2W
11129657|NCT01750918|OG000|Outcome|Part 1+2A+2B - Triple Combination (D+T+P): All Participants With PK Data|Participants in Part 1+2A+2B - Triple combination (D+T+P) of the study (all doses) with available pharmacokinetic data
11129658|NCT01750918|OG000|Outcome|Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129659|NCT01750918|OG001|Outcome|Part 4A+4B - Double Combination (T+P): TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129660|NCT01750918|OG002|Outcome|Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129661|NCT01750918|OG000|Outcome|Part 4A+4B - Double Combination (T+P): All Participants With PK Data|Participants in Part 4A+4B of the study (all doses) with available pharmacokinetic data
11129662|NCT01750918|EG000|Reported Event|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 4.8MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 1.5 mg QD + Panitumumab 4.8 mg/kg Q2W
11129663|NCT01750918|EG001|Reported Event|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129664|NCT01750918|EG002|Reported Event|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129665|NCT01750918|EG003|Reported Event|Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 6MG/KG Q2W|Part 1+2A+2B - Triple combination (Trametinib + Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129666|NCT01750918|EG004|Reported Event|Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 2.0 mg QD + Panitumumab 6.0 mg/kg Q2W
11129667|NCT01750918|EG005|Reported Event|Part 4A+4B - Double Combination (T+P): TRA 1.5MG QD, PAN 6MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 1.5 mg QD + Panitumumab 6.0 mg/kg Q2W
11129668|NCT01750918|EG006|Reported Event|Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 4.8MG/KG Q2W|Part 4A+4B - Double combination (Trametinib + Panitumumab): Trametinib 2.0 mg QD + Panitumumab 4.8 mg/kg Q2W
11129669|NCT01750918|EG007|Reported Event|Part 1+2A - Double Combination (D+P): DAB 150MG BID, PAN 6MG/KG Q2W|Part 1+2A - Double combination (Dabrafenib + Panitumumab): Dabrafenib 150 mg BID + Panitumumab 6.0 mg/kg Q2W
11129670|NCT01750931|BG000|Baseline|GSK-meloxicam 15 mg + Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) or reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
11129671|NCT01750931|FG000|Participant Flow|GSK-meloxicam Then Mobic-meloxicam|In this period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) followed by reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
11129672|NCT01750931|FG001|Participant Flow|Mobic-meloxicam Then GSK-meloxicam|In this period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) followed by test (GSK-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
11129673|NCT01750931|OG000|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
11129674|NCT01750931|OG001|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
11129675|NCT01750931|EG000|Reported Event|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
11129676|NCT01750931|EG001|Reported Event|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
11129677|NCT01751022|BG000|Baseline|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
11129678|NCT01751022|BG001|Baseline|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
11129679|NCT01751022|BG002|Baseline|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
11129680|NCT01751022|BG003|Baseline|Total|Total of all reporting groups
11129681|NCT01751022|FG000|Participant Flow|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
11129682|NCT01751022|FG001|Participant Flow|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
11129683|NCT01751022|FG002|Participant Flow|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
11129684|NCT01751022|OG000|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
11129685|NCT01751022|OG001|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
11129686|NCT01751022|OG002|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
11129687|NCT01751022|OG000|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
11129688|NCT01751022|OG001|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
11129689|NCT01751022|OG002|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
11129690|NCT01751022|OG000|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
11129691|NCT01751022|OG001|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
11129692|NCT01751022|OG002|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month.
11129693|NCT01751022|OG000|Outcome|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
11129694|NCT01751022|OG001|Outcome|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
11129695|NCT01751022|OG002|Outcome|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
11129696|NCT01751022|OG000|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
11129697|NCT01751022|OG001|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
11129698|NCT01751022|OG002|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
11129699|NCT01751022|OG001|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up.
11129700|NCT01751022|OG000|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
11129701|NCT01751022|OG001|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
11129702|NCT01751022|OG002|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
11129703|NCT01751022|OG000|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
11129704|NCT01751022|OG001|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
11129705|NCT01751022|OG002|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
11129706|NCT01751022|EG000|Reported Event|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014.
11129707|NCT01751022|EG001|Reported Event|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014.
11129708|NCT01751022|EG002|Reported Event|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.
11129709|NCT01751061|BG000|Baseline|Decision Aid|"Web-based decision aid (decision support tool) provided to surrogate decision maker~Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions"
11129710|NCT01751061|BG001|Baseline|Usual Care|"usual care in an intensive care unit setting~Usual care: usual ICU care"
11129711|NCT01751061|BG002|Baseline|Total|Total of all reporting groups
11129712|NCT01751061|FG000|Participant Flow|Decision Aid|"Web-based decision aid (decision support tool) provided to surrogate decision maker~Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions"
11129713|NCT01751061|FG001|Participant Flow|Usual Care|"usual care in an intensive care unit setting~Usual care: usual ICU care"
11129714|NCT01751061|OG000|Outcome|Decision Aid|"Web-based decision aid (decision support tool) provided to surrogate decision maker~Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions"
11129715|NCT01751061|OG001|Outcome|Usual Care|"usual care in an intensive care unit setting~Usual care: usual ICU care"
11129716|NCT01751061|EG000|Reported Event|Decision Aid|"Web-based decision aid (decision support tool) provided to surrogate decision maker~Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions"
11129717|NCT01751061|EG001|Reported Event|Usual Care|"usual care in an intensive care unit setting~Usual care: usual ICU care"
11129718|NCT01751087|BG000|Baseline|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
11129719|NCT01751087|BG001|Baseline|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
11129720|NCT01751087|BG002|Baseline|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
11129721|NCT01751087|BG003|Baseline|Total|Total of all reporting groups
11129722|NCT01751087|FG000|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
11129723|NCT01751087|FG001|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
11129724|NCT01751087|FG002|Participant Flow|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
11129725|NCT01751087|OG000|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
11129726|NCT01751087|OG001|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
11129727|NCT01751087|OG002|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
11129728|NCT01751087|EG000|Reported Event|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
11129729|NCT01751087|EG001|Reported Event|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
11129730|NCT01751087|EG002|Reported Event|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
11129731|NCT01751113|BG000|Baseline|Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|All participants received one of the following 3 treatments in one of three 4-week treatment periods separated by a 2-week washout period:Ado 50/250 µg BID (morning and evening) + Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) + Tio matching placebo QD (morning), and Tio 18 µg QD (morning) + Ado matching placebo BID (morning and evening). Participants were randomized to one of the 6 following treatment sequences: (1) Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg (2) Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg (3) Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg (4) Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg (5) Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg (6) Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg. Ado 50/250 µg and its matching placebo were administered via DISKUS inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants used salbutamol inhaler as relief medication throughout the study.
11129732|NCT01751113|FG000|Participant Flow|Sequence 1: Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg|Participants received salmeterol xinafoate/fluticasone propionate (Ado) 50/250 micrograms (µg) twice daily (BID) (morning and evening) plus tiotropium bromide (Tio) 18 µg once daily (QD) (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129733|NCT01751113|FG001|Participant Flow|Sequence 2: Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129734|NCT01751113|FG002|Participant Flow|Sequence 3: Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129735|NCT01751113|FG003|Participant Flow|Sequence 4: Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129736|NCT01751113|FG004|Participant Flow|Sequence 5: Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|Participants received Ado 50/250 µg BID plus Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
11129737|NCT01751113|FG005|Participant Flow|Sequence 6: Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
11129738|NCT01751113|OG000|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129739|NCT01751113|OG001|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129740|NCT01751113|OG002|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129741|NCT01751113|OG001|Outcome|Tio 18 µg BID|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129742|NCT01751113|EG000|Reported Event|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129743|NCT01751113|EG001|Reported Event|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129744|NCT01751113|EG002|Reported Event|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
11129745|NCT01751139|BG000|Baseline|Total Group|Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
11129746|NCT01751139|FG000|Participant Flow|Total Group|Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
11129747|NCT01751139|OG000|Outcome|Total Group|Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
11129748|NCT01751139|EG000|Reported Event|Total Group|Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
11129749|NCT01751165|BG000|Baseline|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
10849111|NCT00294047|FG001|Participant Flow|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11129750|NCT01751165|BG001|Baseline|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
11129751|NCT01751165|BG002|Baseline|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
11129752|NCT01751165|BG003|Baseline|Total|Total of all reporting groups
11129753|NCT01751165|FG000|Participant Flow|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
11129754|NCT01751165|FG001|Participant Flow|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
11129755|NCT01751165|FG002|Participant Flow|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
11129756|NCT01751165|OG000|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
11129757|NCT01751165|OG001|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
11129758|NCT01751165|OG000|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
11129759|NCT01751165|OG001|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
11129760|NCT01751165|OG002|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
11129761|NCT01751165|EG000|Reported Event|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
11129762|NCT01751165|EG001|Reported Event|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
11129763|NCT01751165|EG002|Reported Event|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
11129764|NCT01751178|BG000|Baseline|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129765|NCT01751178|BG001|Baseline|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129766|NCT01751178|BG002|Baseline|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
11129767|NCT01751178|BG003|Baseline|Total|Total of all reporting groups
11129768|NCT01751178|FG000|Participant Flow|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129769|NCT01751178|FG001|Participant Flow|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129770|NCT01751178|FG002|Participant Flow|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
11129771|NCT01751178|OG000|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129772|NCT01751178|OG001|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129773|NCT01751178|OG002|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
11129774|NCT01751178|OG002|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks
11129775|NCT01751178|OG002|Outcome|Reference|Brusing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
11129776|NCT01751178|OG001|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129777|NCT01751178|OG002|Outcome|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
11129778|NCT01751178|EG000|Reported Event|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129779|NCT01751178|EG001|Reported Event|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
11129780|NCT01751178|EG002|Reported Event|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
11129781|NCT01751230|BG000|Baseline|WIC E-Moms|Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
11129782|NCT01751230|BG001|Baseline|WIC Moms|Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
11129783|NCT01751230|BG002|Baseline|Total|Total of all reporting groups
11129784|NCT01751230|FG000|Participant Flow|WIC E-Moms|Participants enrolled in the WIC E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
11129785|NCT01751230|FG001|Participant Flow|WIC Moms|Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
11129786|NCT01751230|OG000|Outcome|WIC E-Moms|Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
11129787|NCT01751230|OG001|Outcome|WIC Moms|Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
11129788|NCT01751230|OG000|Outcome|Low Adherers|Subgroup of E-Moms Intervention group meeting less than and/or equal to 40% of expected number of days for logging weights and recording steps.
11129789|NCT01751230|OG001|Outcome|Medium Adherers|Subgroup of E-Moms Intervention group meeting 40.1%-70% (3-5 days of engagement per week) of expected number of days for logging weights and recording steps.
11129790|NCT01751230|OG002|Outcome|High Adherers|Subgroup of E-Moms Intervention group meeting greater than 70% (5 or more days of engagement per week) of expected number of days for logging weights and recording steps.
11129791|NCT01751230|OG003|Outcome|WIC Moms|Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
11129792|NCT01751230|EG000|Reported Event|WIC E-Moms|Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
11129793|NCT01751230|EG001|Reported Event|WIC Moms|Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
11129794|NCT01751308|BG000|Baseline|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129795|NCT01751308|BG001|Baseline|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129796|NCT01751308|BG002|Baseline|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129797|NCT01751308|BG003|Baseline|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129798|NCT01751308|BG004|Baseline|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129799|NCT01751308|BG005|Baseline|Total|Total of all reporting groups
11129800|NCT01751308|FG000|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse events (AE) or death (from any cause).
11129801|NCT01751308|FG001|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129802|NCT01751308|FG002|Participant Flow|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129803|NCT01751308|FG003|Participant Flow|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129804|NCT01751308|FG004|Participant Flow|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129805|NCT01751308|OG000|Outcome|Phase 1: Overall Population|Cabazitaxel 20 mg/m^2, 25 mg/m^2, 30 mg/m^2 or 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129806|NCT01751308|OG000|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129807|NCT01751308|OG000|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129808|NCT01751308|OG001|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129809|NCT01751308|OG002|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129810|NCT01751308|OG003|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129811|NCT01751308|OG004|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129812|NCT01751308|OG002|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
11129813|NCT01751308|OG001|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AEor death (from any cause).
11129814|NCT01751308|EG000|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129815|NCT01751308|EG001|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129816|NCT01751308|EG002|Reported Event|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129817|NCT01751308|EG003|Reported Event|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129818|NCT01751308|EG004|Reported Event|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
11129819|NCT01751386|BG000|Baseline|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
11129820|NCT01751386|BG001|Baseline|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
11129821|NCT01751386|BG002|Baseline|Total|Total of all reporting groups
11129822|NCT01751386|FG000|Participant Flow|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
11129823|NCT01751386|FG001|Participant Flow|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
11129824|NCT01751386|OG000|Outcome|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
11129825|NCT01751386|OG001|Outcome|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
11129826|NCT01751386|EG000|Reported Event|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
11129827|NCT01751386|EG001|Reported Event|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
11149560|NCT01871506|OG000|Outcome|Standard Treatment (ST)|"Participants randomized to standard treatment will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.~(2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.~(3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects."
11149561|NCT01871506|OG001|Outcome|Intensive Treatment (IT)|"Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the ST arm. IT participants have the option to also receive:~Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).~Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication [varenicline, bupropion, or combination NRT (patch + lozenge)] at no cost to the participant.~Intensive Treatment (IT): The IT model includes all components of the ST as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication."
11149562|NCT01871506|OG000|Outcome|Standard Treatment (ST)|"Participants randomized to standard treatment will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.~(2) 3 Weekly Follow-up Counseling Sessions: ST Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.~(3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects."
11149563|NCT01871506|OG001|Outcome|Intensive Treatment (IT)|"Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive:~Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).~Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication [varenicline, bupropion, or combination NRT (patch + lozenge)] at no cost to the participant.~Intensive Counseling: The IT model includes all components of the ST as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication."
11149564|NCT01871506|OG001|Outcome|Intensive Treatment|"Participants randomized to IT will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive:~."
10849112|NCT00294047|OG000|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11129828|NCT01751399|BG000|Baseline|LY2605541-Normal Hepatic Function|Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541
10849113|NCT00294047|OG001|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11129829|NCT01751399|BG001|Baseline|LY2605541-Mild Hepatic Impairment|Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129830|NCT01751399|BG002|Baseline|LY2605541-Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129831|NCT01751399|BG003|Baseline|LY2605541-Severe Hepatic Impairment|Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129832|NCT01751399|BG004|Baseline|Total|Total of all reporting groups
11129833|NCT01751399|FG000|Participant Flow|LY2605541-Normal Hepatic Function|Participants with normal hepatic function received a single subcutaneous (SC) dose of 0.075 milligrams per kilogram (mg/kg) LY2605541
11129834|NCT01751399|FG001|Participant Flow|LY2605541-Mild Hepatic Impairment|Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129835|NCT01751399|FG002|Participant Flow|LY2605541-Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129836|NCT01751399|FG003|Participant Flow|LY2605541-Severe Hepatic Impairment|Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129837|NCT01751399|OG000|Outcome|LY2605541-Normal Hepatic Function|Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541
11129838|NCT01751399|OG001|Outcome|LY2605541-Mild Hepatic Impairment|Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129839|NCT01751399|OG002|Outcome|LY2605541-Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129840|NCT01751399|OG003|Outcome|LY2605541-Severe Hepatic Impairment|Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129841|NCT01751399|EG000|Reported Event|LY2605541-Normal Hepatic Function|Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541
11129842|NCT01751399|EG001|Reported Event|LY2605541-Mild Hepatic Impairment|Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129843|NCT01751399|EG002|Reported Event|LY2605541-Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129844|NCT01751399|EG003|Reported Event|LY2605541-Severe Hepatic Impairment|Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
11129845|NCT01751412|BG000|Baseline|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
11129846|NCT01751412|FG000|Participant Flow|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
11129847|NCT01751412|OG000|Outcome|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
11129848|NCT01751412|EG000|Reported Event|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
11129849|NCT01751451|BG000|Baseline|Abiraterone Acetate|"Group 1~Abiraterone acetate 1000 mg daily x 8 months~Prednisone 5 mg once daily x 8 months~Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food."
11129850|NCT01751451|BG001|Baseline|Abiraterone Acetate and Degarelix|"Group 2~Abiraterone acetate 1000 mg daily x 8 months~Prednisone 5 mg once daily x 8 months~Degarelix subcutaneous depot injection q 1 month x 8 months~Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter."
11129851|NCT01751451|BG002|Baseline|Degarelix|"Group 3~• Degarelix subcutaneous depot injection q 1 month x 8 months~Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter."
11129852|NCT01751451|BG003|Baseline|Total|Total of all reporting groups
11129853|NCT01751451|FG000|Participant Flow|Abiraterone Acetate|"Group 1~Abiraterone acetate 1000 mg daily x 8 months~Prednisone 5 mg once daily x 8 months~Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food."
11129854|NCT01751451|FG001|Participant Flow|Abiraterone Acetate and Degarelix|"Group 2~Abiraterone acetate 1000 mg daily x 8 months~Prednisone 5 mg once daily x 8 months~Degarelix subcutaneous depot injection q 1 month x 8 months~Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter."
11129855|NCT01751451|FG002|Participant Flow|Degarelix|"Group 3~• Degarelix subcutaneous depot injection q 1 month x 8 months~Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter."
11129856|NCT01751451|OG000|Outcome|Abiraterone Acetate|"Group 1~Abiraterone acetate 1000 mg daily x 8 months~Prednisone 5 mg once daily x 8 months~Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food."
11129857|NCT01751451|OG001|Outcome|Abiraterone Acetate and Degarelix|"Group 2~Abiraterone acetate 1000 mg daily x 8 months~Prednisone 5 mg once daily x 8 months~Degarelix subcutaneous depot injection q 1 month x 8 months~Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter."
11129858|NCT01751451|OG002|Outcome|Degarelix|"Group 3~• Degarelix subcutaneous depot injection q 1 month x 8 months~Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter."
11129859|NCT01751451|EG000|Reported Event|Abiraterone Acetate|"Group 1~Abiraterone acetate 1000 mg daily x 8 months~Prednisone 5 mg once daily x 8 months~Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food."
11129860|NCT01751451|EG001|Reported Event|Abiraterone Acetate and Degarelix|"Group 2~Abiraterone acetate 1000 mg daily x 8 months~Prednisone 5 mg once daily x 8 months~Degarelix subcutaneous depot injection q 1 month x 8 months~Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter."
11129861|NCT01751451|EG002|Reported Event|Degarelix|"Group 3~• Degarelix subcutaneous depot injection q 1 month x 8 months~Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter."
11129862|NCT01751568|BG000|Baseline|Cohort 1: ≥ 2 to < 6 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets, starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129863|NCT01751568|BG001|Baseline|Cohort 2: ≥ 6 to < 12 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets, starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129864|NCT01751568|BG002|Baseline|Cohort 3: : ≥ 4 Weeks to < 2 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets (as a dispersible tablet), starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129865|NCT01751568|BG003|Baseline|Total|Total of all reporting groups
11129866|NCT01751568|FG000|Participant Flow|Cohort 1: ≥ 2 to < 6 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets, starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129867|NCT01751568|FG001|Participant Flow|Cohort 2: ≥ 6 to < 12 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets, starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129868|NCT01751568|FG002|Participant Flow|Cohort 3: : ≥ 4 Weeks to < 2 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets (as a dispersible tablet), starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129869|NCT01751568|OG000|Outcome|Cohort 1: ≥ 2 to < 6 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets, starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129870|NCT01751568|OG001|Outcome|Cohort 2: ≥ 6 to < 12 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets, starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129871|NCT01751568|OG002|Outcome|Cohort 3: : ≥ 4 Weeks to < 2 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets (as a dispersible tablet), starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129872|NCT01751568|EG000|Reported Event|Cohort 1: ≥ 2 to < 6 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets, starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129873|NCT01751568|EG001|Reported Event|Cohort 2: ≥ 6 to < 12 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets, starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129874|NCT01751568|EG002|Reported Event|Cohort 3: : ≥ 4 Weeks to < 2 Years of Age on TB Treatment|"Participants in this cohort received chewable raltegravir tablets (as a dispersible tablet), starting dose of 12 mg/kg (up to a maximum of 800 mg) orally twice daily, in addition to two NRTIs to treat HIV as part of standard of care, and a rifampicin-containing regimen to treat TB. After a study visit at Day 5 to 8, a fourth ARV medication was added to the regimen.~Raltegravir: Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily."
11129875|NCT01751646|BG000|Baseline|Group A: Vitamin D3 50,000 IU|"Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily.~Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT"
11129876|NCT01751646|BG001|Baseline|Group B: Vitamin D3 Placebo|"Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily.~Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT"
11129877|NCT01751646|BG002|Baseline|Total|Total of all reporting groups
11129878|NCT01751646|FG000|Participant Flow|Group A: Vitamin D3 50,000 IU|"Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily.~Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT"
11129879|NCT01751646|FG001|Participant Flow|Group B: Vitamin D3 Placebo|"Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily.~Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT"
11129880|NCT01751646|OG000|Outcome|Group A: Vitamin D3 50,000 IU|"Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily.~Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT"
11129881|NCT01751646|OG001|Outcome|Group B: Vitamin D3 Placebo|"Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily.~Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT"
11129882|NCT01751646|OG000|Outcome|Efavirenz Use|Ever used efavirenz
11129883|NCT01751646|OG001|Outcome|No Efavirenz Use|Never used efavirenz
11129884|NCT01751646|OG000|Outcome|Ritonavir Use|Ever used ritonavir
11129885|NCT01751646|OG001|Outcome|No Ritonavir Use|Never used ritonavir
11129886|NCT01751646|EG000|Reported Event|Group A: Vitamin D3 50,000 IU|"Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily.~Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT"
11129887|NCT01751646|EG001|Reported Event|Group B: Vitamin D3 Placebo|"Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily.~Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT"
11226842|NCT02378480|FG000|Participant Flow|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 12 hours (q12h) (2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg oral administration q24h after a minimum of 3 days (6 doses) of IV treatment (6 overall IV doses because of the blinding). Participants received 4 active doses plus 2 placebo doses to maintain the blind. The total treatment duration was 7 to 14 days.
11008583|NCT01097616|EG008|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
11008584|NCT01097616|EG009|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008585|NCT01097616|EG010|Reported Event|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11226843|NCT02378480|FG001|Participant Flow|Linezolid|Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days.
11008586|NCT01097616|EG011|Reported Event|Suvorexant LD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant LD during TRT/EXT Phase.
11008587|NCT01097616|EG012|Reported Event|Suvorexant HD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant HD during TRT/EXT Phase.
11008588|NCT01097616|EG013|Reported Event|Placebo (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received placebo during TRT/EXT Phase.
11008589|NCT01097616|EG014|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT and RO Phases.
11008590|NCT01097616|EG015|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT Phase and placebo during RO Phase.
11008591|NCT01097616|EG016|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT and RO Phases.
11008592|NCT01097616|EG017|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT Phase and placebo during RO Phase.
11008593|NCT01097616|EG018|Reported Event|Placebo (RO, After Placebo in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT/EXT and RO Phases.
11008594|NCT01097629|BG000|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008595|NCT01097629|BG001|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008596|NCT01097629|BG002|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
11008597|NCT01097629|BG003|Baseline|Total|Total of all reporting groups
11008598|NCT01097629|FG000|Participant Flow|Suvorexant Low Dose (LD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008599|NCT01097629|FG001|Participant Flow|Suvorexant High Dose (HD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008600|NCT01097629|FG002|Participant Flow|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
11008601|NCT01097629|FG003|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
11008602|NCT01097629|FG004|Participant Flow|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008603|NCT01097629|FG005|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
11008604|NCT01097629|FG006|Participant Flow|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008605|NCT01097629|FG007|Participant Flow|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008606|NCT01097629|OG000|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008607|NCT01097629|OG001|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
11129888|NCT01751724|BG000|Baseline|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
11129889|NCT01751724|BG001|Baseline|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
11129890|NCT01751724|BG002|Baseline|Total|Total of all reporting groups
11129891|NCT01751724|FG000|Participant Flow|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
11129892|NCT01751724|FG001|Participant Flow|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
11129893|NCT01751724|OG000|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
11129894|NCT01751724|OG001|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
11129895|NCT01751724|EG000|Reported Event|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
11129896|NCT01751724|EG001|Reported Event|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
11129897|NCT01751802|BG000|Baseline|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
11129898|NCT01751802|BG001|Baseline|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
11129899|NCT01751802|BG002|Baseline|Total|Total of all reporting groups
11129900|NCT01751802|FG000|Participant Flow|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
11129901|NCT01751802|FG001|Participant Flow|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
11129902|NCT01751802|OG000|Outcome|Subject #1: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
11129903|NCT01751802|OG001|Outcome|Subject #2: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
11129904|NCT01751802|OG002|Outcome|Subject #3: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
11129905|NCT01751802|OG003|Outcome|Subject #4: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
11129906|NCT01751802|OG000|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime~Ecopipam: Antagonist of the dopamine D1 receptor"
11129907|NCT01751802|OG001|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime~Placebo: Placebo for Ecopipam"
11129908|NCT01751802|OG000|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime for 6 weeks~Ecopipam: Antagonist of the dopamine D1 receptor"
11129909|NCT01751802|OG001|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime for 6 weeks~Placebo: Placebo for Ecopipam"
11129910|NCT01751802|EG000|Reported Event|Ecopipam|"Active substance being tested, orally once a day at bedtime~Ecopipam: Antagonist of the dopamine D1 receptor"
11008608|NCT01097629|OG000|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11129911|NCT01751802|EG001|Reported Event|Placebo|"Inactive substance being tested, orally once a day at bedtime~Placebo: Placebo for Ecopipam"
11129912|NCT01751867|BG000|Baseline|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
11129913|NCT01751867|BG001|Baseline|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
11129914|NCT01751867|BG002|Baseline|Total|Total of all reporting groups
11129915|NCT01751867|FG000|Participant Flow|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
11129916|NCT01751867|FG001|Participant Flow|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
11129917|NCT01751867|OG000|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
11129918|NCT01751867|OG001|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
11129919|NCT01751867|EG000|Reported Event|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
11129920|NCT01751867|EG001|Reported Event|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
11129921|NCT01751971|BG000|Baseline|Oxygen First|"Participants participate in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second~Inspired oxygen (40%): Supplemental oxygen at approximately 40% e.g. via Pink venturi mask"
11129922|NCT01751971|BG001|Baseline|Air First|"Participants participate in the air night (sham) first, then the oxygen night second.~Sham: Medical air with 21% oxygen e.g. via Pink venturi mask"
11129923|NCT01751971|BG002|Baseline|Total|Total of all reporting groups
11129924|NCT01751971|FG000|Participant Flow|Oxygen First|"Participants participate in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second~Inspired oxygen (40%): Supplemental oxygen at approximately 40% e.g. via Pink venturi mask"
11129925|NCT01751971|FG001|Participant Flow|Air First|"Participants participate in the air night (sham) first, then the oxygen night second.~Sham: Medical air with 21% oxygen e.g. via Pink venturi mask"
11129926|NCT01751971|OG000|Outcome|Inspired Oxygen|Inspired oxygen (40%) for 1 night via venturi mask.
11129927|NCT01751971|OG001|Outcome|Sham|Sham: Medical air with 21% oxygen via venturi mask
11129928|NCT01751971|OG000|Outcome|Inspired Oxygen|Inspired oxygen (40%): Supplemental oxygen at approximately 40% e.g. via Pink venturi mask
11129929|NCT01751971|OG001|Outcome|Sham|Sham: Medical air with 21% oxygen e.g. via Pink venturi mask
11129930|NCT01751971|OG000|Outcome|Inspired Oxygen|"Inspired oxygen (40%) for 1 night via venturi mask. Arm here is defined as the Oxygen Intervention. 18 participants participated in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second. 18 participants participated in the other order."
11129931|NCT01751971|OG001|Outcome|Sham|"Sham: Medical air with 21% oxygen e.g. via Pink venturi mask Arm here is defined as the Sham Intervention. 18 participants participated in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second. 18 participants participated in the other order."
11129932|NCT01751971|OG000|Outcome|All Participants|Data are presented as a single arm because results are inherently a comparison between arms. Participants were asked to rate whether their sleep quality was better/same/worse on study night 2 versus study night 1. Data are presented in terms of better/same/worse on oxygen compared to sham.
11129933|NCT01751971|OG000|Outcome|Inspired Oxygen|Inspired oxygen (40%) via Pink venturi mask
11129934|NCT01751971|EG000|Reported Event|Inspired Oxygen|Inspired Oxygen 40%
11129935|NCT01751971|EG001|Reported Event|Sham|Sham, room air
11129936|NCT01752036|BG000|Baseline|Treatment|Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
11129937|NCT01752036|FG000|Participant Flow|Treatment|Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
11129938|NCT01752036|OG000|Outcome|Treatment|Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
11129939|NCT01752036|OG000|Outcome|Treatment|"Post-Operative Stereotactic Radiosurgery~Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions"
11129940|NCT01752036|EG000|Reported Event|Treatment|Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions
11129941|NCT01752400|BG000|Baseline|AUY922|"Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes~AUY922"
11129942|NCT01752400|FG000|Participant Flow|AUY922|"Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes~AUY922"
11129943|NCT01752400|OG000|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
11129944|NCT01752400|EG000|Reported Event|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
11129945|NCT01752413|BG000|Baseline|Ferrous Gluconate 325mg|"Those found iron depleted by ferritin measure will receive 325 mg Ferrous gluconate twice a day for 100 days. They will be deferred as a whole blood donor for 120 days until completion of iron therapy. They will receive standard dietary counseling.~Ferrous gluconate 325mg: Participants with low ferritin (<30 micrograms/L (males) or <20 micrograms/L (females)) will be asked to take two tablets of Ferrous Gluconate 325 mg (36 mg elemental iron) per day.~Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods"
11129946|NCT01752413|BG001|Baseline|Nutrition Counseling|"For those consenting to this study but who demonstrate adequate ferritin levels (>20 micrograms/L female, >30 micrograms/L males), they will not receive oral iron or additional deferral period but will be allowed to donate after the standard 56 days. They will receive standard counseling about iron rich foods. Rate and frequency of subsequent donations will be tracked and compared to those receiving iron supplementation.~Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods"
11129947|NCT01752413|BG002|Baseline|Total|Total of all reporting groups
11129948|NCT01752413|FG000|Participant Flow|Ferrous Gluconate 325mg|"Those found iron depleted by ferritin measure will receive 325 mg Ferrous gluconate twice a day for 100 days. They will be deferred as a whole blood donor for 120 days until completion of iron therapy. They will receive standard dietary counseling.~Ferrous gluconate 325mg: Participants with low ferritin (<30 micrograms/L (males) or <20 micrograms/L (females)) will be asked to take two tablets of Ferrous Gluconate 325 mg (36 mg elemental iron) per day.~Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods"
11129949|NCT01752413|FG001|Participant Flow|Nutrition Counseling|"For those consenting to this study but who demonstrate adequate ferritin levels (>20 micrograms/L female, >30 micrograms/L males), they will not receive oral iron or additional deferral period but will be allowed to donate after the standard 56 days. They will receive standard counseling about iron rich foods. Rate and frequency of subsequent donations will be tracked and compared to those receiving iron supplementation.~Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods"
11129950|NCT01752413|OG000|Outcome|Ferrous Gluconate 325mg|"Those found iron depleted by ferritin measure will receive 325 mg Ferrous gluconate twice a day for 100 days. They will be deferred as a whole blood donor for 120 days until completion of iron therapy. They will receive standard dietary counseling.~Ferrous gluconate 325mg: Participants with low ferritin (<30 micrograms/L (males) or <20 micrograms/L (females)) will be asked to take two tablets of Ferrous Gluconate 325 mg (36 mg elemental iron) per day.~Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods"
11129951|NCT01752413|OG001|Outcome|Nutrition Counseling|"For those consenting to this study but who demonstrate adequate ferritin levels (>20 micrograms/L female, >30 micrograms/L males), they will not receive oral iron or additional deferral period but will be allowed to donate after the standard 56 days. They will receive standard counseling about iron rich foods. Rate and frequency of subsequent donations will be tracked and compared to those receiving iron supplementation.~Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods"
11129952|NCT01752413|EG000|Reported Event|Ferrous Gluconate 325mg|"Those found iron depleted by ferritin measure will receive 325 mg Ferrous gluconate twice a day for 100 days. They will be deferred as a whole blood donor for 120 days until completion of iron therapy. They will receive standard dietary counseling.~Ferrous gluconate 325mg: Participants with low ferritin (<30 micrograms/L (males) or <20 micrograms/L (females)) will be asked to take two tablets of Ferrous Gluconate 325 mg (36 mg elemental iron) per day.~Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods"
11129953|NCT01752413|EG001|Reported Event|Nutrition Counseling|"For those consenting to this study but who demonstrate adequate ferritin levels (>20 micrograms/L female, >30 micrograms/L males), they will not receive oral iron or additional deferral period but will be allowed to donate after the standard 56 days. They will receive standard counseling about iron rich foods. Rate and frequency of subsequent donations will be tracked and compared to those receiving iron supplementation.~Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods"
11129954|NCT01752426|BG000|Baseline|Heavy Water + PCI-32765|"50ml 70% 2^H2O (Heavy Water) 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks (labeling phase). Subjects given first dose in clinic. Subjects then given individual doses of 2^H2O to consume at home; after the 5-day loading period, a 60 ml maintenance dose of 2^H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2^H2O (washout phase) and be followed from 6-12 weeks until beginning treatment with PCI-32765. PCI-32765 administered with 8 ounces (~240mL) of water at a dose of 420 mg (3 x 140mg capsules) orally once daily and continued daily. Treatment duration is 12 cycles, with each cycle consisting of 28 days.~Heavy Water (2^H2O): 50 ml 70% 2^H2O 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks. After the 5-day loading period, a 60 ml maintenance dose of 2^H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2^H2O (washout phase) and be followed from 6-12"
11129955|NCT01752426|FG000|Participant Flow|Heavy Water + PCI-32765|"50ml 70% 2^H2O (Heavy Water) 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks (labeling phase). Subjects given first dose in clinic. Subjects then given individual doses of 2^H2O to consume at home; after the 5-day loading period, a 60 ml maintenance dose of 2^H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2^H2O (washout phase) and be followed from 6-12 weeks until beginning treatment with PCI-32765. PCI-32765 administered with 8 ounces (~240mL) of water at a dose of 420 mg (3 x 140mg capsules) orally once daily and continued daily. Treatment duration is 12 cycles, with each cycle consisting of 28 days.~Heavy Water (2^H2O): 50 ml 70% 2^H2O 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks. After the 5-day loading period, a 60 ml maintenance dose of 2^H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2^H2O (washout phase) and be followed from 6-12"
11129956|NCT01752426|OG000|Outcome|Heavy Water + PCI-32765|"50ml 70% 2^H2O (Heavy Water) 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks (labeling phase). Subjects given first dose in clinic. Subjects then given individual doses of 2^H2O to consume at home; after the 5-day loading period, a 60 ml maintenance dose of 2^H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2^H2O (washout phase) and be followed from 6-12 weeks until beginning treatment with PCI-32765. PCI-32765 administered with 8 ounces (~240mL) of water at a dose of 420 mg (3 x 140mg capsules) orally once daily and continued daily. Treatment duration is 12 cycles, with each cycle consisting of 28 days.~Heavy Water (2^H2O): 50 ml 70% 2^H2O 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks. After the 5-day loading period, a 60 ml maintenance dose of 2^H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2^H2O (washout phase) and be followed from 6-12"
11129957|NCT01752426|EG000|Reported Event|Heavy Water + PCI-32765|"50ml 70% 2^H2O (Heavy Water) 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks (labeling phase). Subjects given first dose in clinic. Subjects then given individual doses of 2^H2O to consume at home; after the 5-day loading period, a 60 ml maintenance dose of 2^H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2^H2O (washout phase) and be followed from 6-12 weeks until beginning treatment with PCI-32765. PCI-32765 administered with 8 ounces (~240mL) of water at a dose of 420 mg (3 x 140mg capsules) orally once daily and continued daily. Treatment duration is 12 cycles, with each cycle consisting of 28 days.~Heavy Water (2^H2O): 50 ml 70% 2^H2O 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks. After the 5-day loading period, a 60 ml maintenance dose of 2^H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2^H2O (washout phase) and be followed from 6-12"
11129958|NCT01752634|BG000|Baseline|Secukinumab (AIN457) 75 mg s.c.|Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 150 mg s.c. or 300 mg s.c
11129959|NCT01752634|BG001|Baseline|Secukinumab (AIN457) 150 mg s.c.|Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c
11129960|NCT01752634|BG002|Baseline|Secukinumab (AIN457) 300 mg s.c.|Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260.
11129961|NCT01752634|BG003|Baseline|Placebo - AIN457 150 mg|Placebo - rerandomized to AIN457 150 mg starting at Week 16 (non-responder) or Week 24 (responder). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c
11129962|NCT01752634|BG004|Baseline|Placebo - AIN457 300 mg|Placebo - rerandomized to AIN457 300 mg starting at Week 16 (non-responder) or Week 24 (responder).
11129963|NCT01752634|BG005|Baseline|Placebo - Not Rerandomized|Placebo - not rerandomized (subjects discontinued prior to rerandomization scheduled for week 16)
11129964|NCT01752634|BG006|Baseline|Total|Total of all reporting groups
11129965|NCT01752634|FG000|Participant Flow|Secukinumab (AIN457) 75 mg s.c.|Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 150 mg s.c. or 300 mg s.c
11129966|NCT01752634|FG001|Participant Flow|Secukinumab (AIN457) 150 mg s.c.|Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c
11129967|NCT01752634|FG002|Participant Flow|Secukinumab (AIN457) 300 mg s.c.|Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260.
11129968|NCT01752634|FG003|Participant Flow|Placebo - AIN457 150 mg|Placebo - rerandomized to AIN457 150 mg starting at Week 16 (non-responder) or Week 24 (responder). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c
11008609|NCT01097629|OG001|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008610|NCT01097629|OG002|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
11008611|NCT01097629|EG000|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008612|NCT01097629|EG001|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
11008613|NCT01097629|EG002|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
11008614|NCT01097629|EG003|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
11008615|NCT01097629|EG004|Reported Event|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008616|NCT01097629|EG005|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
11008617|NCT01097629|EG006|Reported Event|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008618|NCT01097629|EG007|Reported Event|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
11008619|NCT01097629|EG008|Reported Event|Suvorexant LD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant LD during TRT Phase.
11008620|NCT01097629|EG009|Reported Event|Suvorexant HD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant HD during TRT Phase.
11008621|NCT01097629|EG010|Reported Event|Placebo (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received placebo during TRT Phase.
11008622|NCT01097629|EG011|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT and RO Phases.
11008623|NCT01097629|EG012|Reported Event|Placebo (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT Phase and placebo during RO Phase.
11008624|NCT01097629|EG013|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT and RO Phases.
11008625|NCT01097629|EG014|Reported Event|Placebo (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT Phase and placebo during RO Phase.
11008626|NCT01097629|EG015|Reported Event|Placebo (RO, After Placebo in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT and RO Phases.
11008627|NCT01097642|BG000|Baseline|Ixabepilone|"Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.~Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles."
11008628|NCT01097642|BG001|Baseline|Ixabepilone Plus Cetuximab|"Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.~Cetuximab: Cetuximab will be given at 400mg/m^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m^2 IV over 60 minutes.~Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles."
11008629|NCT01097642|BG002|Baseline|Total|Total of all reporting groups
11008630|NCT01097642|FG000|Participant Flow|Ixabepilone|"Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.~Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles."
11008631|NCT01097642|FG001|Participant Flow|Ixabepilone Plus Cetuximab|"Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.~Cetuximab: Cetuximab will be given at 400mg/m^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m^2 IV over 60 minutes.~Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles."
11008632|NCT01097642|OG000|Outcome|Ixabepilone|"Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.~Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles."
11129969|NCT01752634|FG004|Participant Flow|Placebo - AIN457 300 mg|Placebo - rerandomized to AIN457 300 mg starting at Week 16 (non-responder) or Week 24 (responder).
11129970|NCT01752634|FG005|Participant Flow|Placebo - Not Rerandomized|Placebo - not rerandomized (subjects discontinued prior to rerandomization scheduled for week 16)
11129971|NCT01752634|OG000|Outcome|Secukinumab (AIN457) 75 mg s.c.|Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 150 mg s.c. or 300 mg s.c
11129972|NCT01752634|OG001|Outcome|Secukinumab (AIN457) 150 mg s.c.|Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c
11129973|NCT01752634|OG002|Outcome|Secukinumab (AIN457) 300 mg s.c.|Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260.
11129974|NCT01752634|OG003|Outcome|Placebo s.c.|Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260.
11129975|NCT01752634|EG000|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg
11129976|NCT01752634|EG001|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
11129977|NCT01752634|EG002|Reported Event|Any AIN457 300 mg|Any AIN457 300 mg
11129978|NCT01752634|EG003|Reported Event|Placebo|Placebo
11129979|NCT01752712|BG000|Baseline|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
11129980|NCT01752712|BG001|Baseline|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
11129981|NCT01752712|BG002|Baseline|Total|Total of all reporting groups
11129982|NCT01752712|FG000|Participant Flow|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
11129983|NCT01752712|FG001|Participant Flow|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
11129984|NCT01752712|OG000|Outcome|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
11129985|NCT01752712|OG001|Outcome|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
11129986|NCT01752712|EG000|Reported Event|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
11129987|NCT01752712|EG001|Reported Event|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
11129988|NCT01752842|BG000|Baseline|Fenofibrate|"One fenofibrate 160 mg capsule per day for 12 weeks~Fenofibrate"
11129989|NCT01752842|BG001|Baseline|Placebo for Fenofibrate|"One inert sugar pill per day for 12 weeks~Placebo for fenofibrate"
11129990|NCT01752842|BG002|Baseline|Total|Total of all reporting groups
11129991|NCT01752842|FG000|Participant Flow|Fenofibrate|"Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks~Fenofibrate"
11129992|NCT01752842|FG001|Participant Flow|Placebo for Fenofibrate|"Participants were instructed to take one inert sugar pill every day for 12 weeks~Placebo for fenofibrate"
11129993|NCT01752842|OG000|Outcome|Fenofibrate|"Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks~Fenofibrate"
11129994|NCT01752842|OG001|Outcome|Placebo for Fenofibrate|"Participants were instructed to take one inert sugar pill every day for 12 weeks~Placebo for fenofibrate"
11129995|NCT01752842|EG000|Reported Event|Fenofibrate|"Participants were instructed to take one fenofibrate 160 mg capsule every day for 12 weeks~Fenofibrate"
11129996|NCT01752842|EG001|Reported Event|Placebo for Fenofibrate|"Participants were instructed to take one inert sugar pill every day for 12 weeks~Placebo for fenofibrate"
11129997|NCT01752855|BG000|Baseline|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
11129998|NCT01752855|BG001|Baseline|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
11129999|NCT01752855|BG002|Baseline|Total|Total of all reporting groups
11130000|NCT01752855|FG000|Participant Flow|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
11130001|NCT01752855|FG001|Participant Flow|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
11130002|NCT01752855|OG000|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
11130003|NCT01752855|OG001|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
11130004|NCT01752855|EG000|Reported Event|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week.
11130005|NCT01752855|EG001|Reported Event|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
11130006|NCT01752907|BG000|Baseline|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
11130007|NCT01752907|BG001|Baseline|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
11130008|NCT01752907|BG002|Baseline|Total|Total of all reporting groups
11130009|NCT01752907|FG000|Participant Flow|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
11130010|NCT01752907|FG001|Participant Flow|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
11130011|NCT01752907|OG000|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
11130012|NCT01752907|OG001|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
11130013|NCT01752907|EG000|Reported Event|General Chemotherapy Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
11130014|NCT01752907|EG001|Reported Event|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
11130015|NCT01752933|BG000|Baseline|Guadecitabine 60 mg/m^2|Guadecitabine (SGI-110) 60 mg/m^2 SC on Days 1 - 5 of each 28-day cycle
11130016|NCT01752933|BG001|Baseline|Guadecitabine 45 mg/m^2|Guadecitabine (SGI-110) 45 mg/m^2 SC on Days 1 - 5 of each 28-day cycle
11130017|NCT01752933|BG002|Baseline|Total|Total of all reporting groups
11130018|NCT01752933|FG000|Participant Flow|Guadecitabine 60 mg/m^2|Guadecitabine (SGI-110) 60 mg/m^2 subcutaneously (SC) on Days 1 - 5 of each 28-day cycle
11130019|NCT01752933|FG001|Participant Flow|Guadecitabine 45 mg/m^2|Guadecitabine (SGI-110) 45 mg/m^2 SC on Days 1 - 5 of each 28-day cycle
11130020|NCT01752933|OG000|Outcome|Guadecitabine 60 mg/m^2|Guadecitabine (SGI-110) 60 mg/m^2 SC on Days 1 - 5 of each 28-day cycle
11130021|NCT01752933|OG001|Outcome|Guadecitabine 45 mg/m^2|Guadecitabine (SGI-110) 45 mg/m^2 on Days 1 - 5 of each 28-day cycle
11130022|NCT01752933|OG001|Outcome|Guadecitabine 45 mg/m^2|Guadecitabine (SGI-110) 45 mg/m^2 SC on Days 1 - 5 of each 28-day cycle
11130023|NCT01752933|EG000|Reported Event|Guadecitabine 60 mg/m^2|Guadecitabine (SGI-110) 60 mg/m^2 SC on Days 1 - 5 of each 28-day cycle
11130024|NCT01752933|EG001|Reported Event|Guadecitabine 45 mg/m^2|Guadecitabine (SGI-110) 45 mg/m^2 SC on Days 1 - 5 of each 28-day cycle
11130025|NCT01752985|BG000|Baseline|BMS-813160 150 mg QD|Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
11130026|NCT01752985|BG001|Baseline|BMS-813160 300 mg BID|Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
11130027|NCT01752985|BG002|Baseline|Placebo|Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
11130028|NCT01752985|BG003|Baseline|Total|Total of all reporting groups
11130029|NCT01752985|FG000|Participant Flow|BMS-813160 150 mg QD|Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
11130030|NCT01752985|FG001|Participant Flow|BMS-813160 300 mg BID|Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
11130031|NCT01752985|FG002|Participant Flow|Placebo|Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
11130032|NCT01752985|OG000|Outcome|BMS-813160 150 mg QD|Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
11130033|NCT01752985|OG001|Outcome|BMS-813160 300 mg BID|Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
11130034|NCT01752985|OG002|Outcome|Placebo|Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
11130035|NCT01752985|EG000|Reported Event|BMS-813160 150 mg QD|Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
11130036|NCT01752985|EG001|Reported Event|BMS-813160 300 mg BID|Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks.
11130037|NCT01752985|EG002|Reported Event|Placebo|Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.
11130038|NCT01753076|BG000|Baseline|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
11130039|NCT01753076|BG001|Baseline|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
11130040|NCT01753076|BG002|Baseline|Total|Total of all reporting groups
11130041|NCT01753076|FG000|Participant Flow|Placebo|Participants (par) received placebo once every 2 weeks by intravenous infusion up to Week 46.
11130042|NCT01753076|FG001|Participant Flow|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
11130043|NCT01753076|OG000|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
11130044|NCT01753076|OG001|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
11130045|NCT01753076|OG000|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Outcome assessments conducted at Week 48 and Week 60.
11130046|NCT01753076|OG001|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 mg/kg once every 2 weeks by intravenous infusion up to Week 46. Outcome assessments conducted at Week 48 and Week 60.
11130047|NCT01753076|EG000|Reported Event|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
11130048|NCT01753076|EG001|Reported Event|Ozanezumab IV|Participants received ozanezumab 15 mg/kg once every 2 weeks by intravenous infusion up to Week 46.
11130049|NCT01753115|BG000|Baseline|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
11130050|NCT01753115|BG001|Baseline|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
11130051|NCT01753115|BG002|Baseline|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
11130052|NCT01753115|BG003|Baseline|Total|Total of all reporting groups
11130053|NCT01753115|FG000|Participant Flow|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
11130054|NCT01753115|FG001|Participant Flow|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
11130055|NCT01753115|FG002|Participant Flow|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
11130056|NCT01753115|OG000|Outcome|Arm 1 = BioThrax (0.5 mL) + Ciprofloxacin (500 mg Bid) + PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
11130057|NCT01753115|OG000|Outcome|BioThrax + Ciprofloxacin (Arms 1 + 2)|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
11130058|NCT01753115|OG001|Outcome|BioThrax Only (Arm 3)|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
11130059|NCT01753115|EG000|Reported Event|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
11130060|NCT01753115|EG001|Reported Event|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
11130061|NCT01753115|EG002|Reported Event|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
11130062|NCT01753193|BG000|Baseline|Anifrolumab|Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
11130063|NCT01753193|FG000|Participant Flow|Anifrolumab|Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
11130064|NCT01753193|OG000|Outcome|Anifrolumab|Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
11130065|NCT01753193|EG000|Reported Event|Anifrolumab|Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
11130066|NCT01753297|BG000|Baseline|Active Surveillance|Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
11130067|NCT01753297|BG001|Baseline|Triptorelin|Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
11130068|NCT01753297|BG002|Baseline|Total|Total of all reporting groups
11130069|NCT01753297|FG000|Participant Flow|Active Surveillance|Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
11130070|NCT01753297|FG001|Participant Flow|Triptorelin|Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 milligrams (mg) triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
11130071|NCT01753297|OG000|Outcome|Active Surveillance|Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
11130072|NCT01753297|OG001|Outcome|Triptorelin|Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
11130073|NCT01753297|OG000|Outcome|Triptorelin|Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
11130074|NCT01753297|EG000|Reported Event|Active Surveillance - Safety Population - Prior to Month 12|"Representing AEs reported in the active surveillance arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded).~Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical)."
10879643|NCT00459108|OG000|Outcome|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
11130075|NCT01753297|EG001|Reported Event|Triptorelin - Safety Population - Prior to Month 12|"Representing TEAEs reported in the triptorelin arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded); corresponding to 12 months after the first triptorelin injection.~Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months)."
11130076|NCT01753297|EG002|Reported Event|Overall Safety Population - Posterior to Month 12|Representing AEs reported in the overall safety population from Month 12 until end of study (Month 12 up to Month 36). Since no active study drug (ie, triptorelin) was administered to any subject during this period, AEs starting from the Month 12 visit were analysed and reported overall (ie, not separately for each treatment arm).
11130077|NCT01753310|BG000|Baseline|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
11130078|NCT01753310|BG001|Baseline|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
11130079|NCT01753310|BG002|Baseline|Total Title|
11130080|NCT01753310|FG000|Participant Flow|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
11130081|NCT01753310|FG001|Participant Flow|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
11130082|NCT01753310|OG000|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
11130083|NCT01753310|OG001|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
11130084|NCT01753310|EG000|Reported Event|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
11130085|NCT01753310|EG001|Reported Event|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
11130086|NCT01753323|BG000|Baseline|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
11130087|NCT01753323|BG001|Baseline|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
11130088|NCT01753323|BG002|Baseline|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
11130089|NCT01753323|BG003|Baseline|Total|Total of all reporting groups
11130090|NCT01753323|FG000|Participant Flow|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
11130091|NCT01753323|FG001|Participant Flow|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
11130092|NCT01753323|FG002|Participant Flow|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
11130093|NCT01753323|OG000|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
11130094|NCT01753323|OG001|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
11130095|NCT01753323|OG002|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
11130096|NCT01753323|OG000|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
11130097|NCT01753323|EG000|Reported Event|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
11130098|NCT01753323|EG001|Reported Event|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
11130099|NCT01753323|EG002|Reported Event|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
11130100|NCT01753336|BG000|Baseline|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11130101|NCT01753336|FG000|Participant Flow|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA).
11130102|NCT01753336|OG000|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11008633|NCT01097642|OG001|Outcome|Ixabepilone Plus Cetuximab|"Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.~Cetuximab: Cetuximab will be given at 400mg/m^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m^2 IV over 60 minutes.~Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles."
11008634|NCT01097642|EG000|Reported Event|Ixabepilone|"Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.~Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles."
11008635|NCT01097642|EG001|Reported Event|Ixabepilone Plus Cetuximab|"Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.~Cetuximab: Cetuximab will be given at 400mg/m^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m^2 IV over 60 minutes.~Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles."
11008636|NCT01097655|BG000|Baseline|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
11008637|NCT01097655|FG000|Participant Flow|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
11008638|NCT01097655|OG000|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
11008639|NCT01097655|EG000|Reported Event|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
11008640|NCT01097668|BG000|Baseline|Intradermal Injection|Injections of ATX-MS-1467 given by the intradermal route
11008641|NCT01097668|BG001|Baseline|Subcutaneous Injection|Injections of ATX-MS-1467 given by the subcutaneous route
11008642|NCT01097668|BG002|Baseline|Total|Total of all reporting groups
11008643|NCT01097668|FG000|Participant Flow|Intradermal Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
11008644|NCT01097668|FG001|Participant Flow|Subcutaneous Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
11008645|NCT01097668|OG000|Outcome|Intradermal Injection|Injections of ATX-MS-1467 administered by the intradermal route
11008646|NCT01097668|OG001|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by the subcutaneous route
11008647|NCT01097668|OG000|Outcome|Intradermal|Injections of ATX-MS-1467 administered by intradermal route
11008648|NCT01097668|OG001|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by subcutaneous route
11008649|NCT01097668|EG000|Reported Event|Intradermal Injection - Treatment Emergent|Injections will be administered by the intradermal route
11008650|NCT01097668|EG001|Reported Event|Subcutaneous Injection - Treatment Emergent|Injections will be administered by the subcutaneous route
11008651|NCT01097668|EG002|Reported Event|Intradermal Injection - Non Treatment Emergent|Follow-up period
11008652|NCT01097668|EG003|Reported Event|Subcutaneous Injection - Non Treatment Emergent|Follow-up period
11008653|NCT01097694|BG000|Baseline|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
11008654|NCT01097694|BG001|Baseline|Placebo|"Group on Placebo treatment~Placebo: Placebo"
11008655|NCT01097694|BG002|Baseline|Total|Total of all reporting groups
11008656|NCT01097694|FG000|Participant Flow|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
11008657|NCT01097694|FG001|Participant Flow|Placebo|"Group on Placebo treatment~Placebo: Placebo"
11008658|NCT01097694|OG000|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
11008659|NCT01097694|OG001|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
11008660|NCT01097694|EG000|Reported Event|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
11008661|NCT01097694|EG001|Reported Event|Placebo|"Group on Placebo treatment~Placebo: Placebo"
11008662|NCT01097707|BG000|Baseline|1 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008663|NCT01097707|BG001|Baseline|3 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008664|NCT01097707|BG002|Baseline|10 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008665|NCT01097707|BG003|Baseline|25 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008666|NCT01097707|BG004|Baseline|Placebo|Placebo: Administered orally, daily for 24 weeks
11008667|NCT01097707|BG005|Baseline|Total|Total of all reporting groups
11008668|NCT01097707|FG000|Participant Flow|1 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008669|NCT01097707|FG001|Participant Flow|3 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008670|NCT01097707|FG002|Participant Flow|10 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008671|NCT01097707|FG003|Participant Flow|25 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008672|NCT01097707|FG004|Participant Flow|Placebo|Placebo: Administered orally, daily for 24 weeks
11008673|NCT01097707|OG000|Outcome|1 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008674|NCT01097707|OG001|Outcome|3 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11130103|NCT01753336|EG000|Reported Event|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11130104|NCT01753362|BG000|Baseline|Placebo|"subcutaneous daily injection~placebo"
11130105|NCT01753362|BG001|Baseline|Liraglutide|"subcutaneous daily injection~liraglutide"
11130106|NCT01753362|BG002|Baseline|Total|Total of all reporting groups
11130107|NCT01753362|FG000|Participant Flow|Placebo|"subcutaneous daily injection~placebo"
11130108|NCT01753362|FG001|Participant Flow|Liraglutide|"subcutaneous daily injection~liraglutide"
11130109|NCT01753362|OG000|Outcome|Placebo|"subcutaneous daily injection~placebo"
11130110|NCT01753362|OG001|Outcome|Liraglutide|"subcutaneous daily injection~liraglutide"
11130111|NCT01753362|EG000|Reported Event|Placebo|"subcutaneous daily injection~placebo"
11130112|NCT01753362|EG001|Reported Event|Liraglutide|"subcutaneous daily injection~liraglutide"
11130113|NCT01753401|BG000|Baseline|Placebo|Participants who were randomized to receive Placebo in Period 1
11130114|NCT01753401|BG001|Baseline|Acthar|Participants who were randomized to receive Acthar in Period 1
11130115|NCT01753401|BG002|Baseline|Total|Total of all reporting groups
11130116|NCT01753401|FG000|Participant Flow|Placebo|Participants receive their randomized regimen of placebo during the double-blind period
11130117|NCT01753401|FG001|Participant Flow|Acthar|Participants receive their randomized regimen of Acthar during the double-blind period
11130118|NCT01753401|FG002|Participant Flow|Placebo/Acthar|Participants who receive Placebo in Part 1, but Acthar in Part 2
11130119|NCT01753401|FG003|Participant Flow|Acthar/Acthar|Participants who receive Acthar in both Parts 1 and 2
11130120|NCT01753401|OG000|Outcome|Placebo|Participants who receive Placebo in Period 1
11130121|NCT01753401|OG001|Outcome|Acthar|Participants who receive Acthar in Period 1
11130122|NCT01753401|OG000|Outcome|Placebo/Acthar|Participants who receive Placebo in Part 1, but Acthar in Part 2
11130123|NCT01753401|OG001|Outcome|Acthar/Acthar|Participants who receive Acthar in both Parts 1 and 2
11130124|NCT01753401|EG000|Reported Event|Period 1: Placebo|Participants who receive Placebo in Period 1
11130125|NCT01753401|EG001|Reported Event|Period 1: Acthar|Participants who receive Acthar in Period 1
11130126|NCT01753401|EG002|Reported Event|Period 2: Placebo/Acthar|Participants who receive Placebo in Period 1, but Acthar in Period 2
11130127|NCT01753401|EG003|Reported Event|Period 2: Acthar/Acthar|Participants who receive Acthar in both Periods 1 and 2
11130128|NCT01753518|BG000|Baseline|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
11130129|NCT01753518|BG001|Baseline|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
11130130|NCT01753518|BG002|Baseline|Total|Total of all reporting groups
11130131|NCT01753518|FG000|Participant Flow|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
11130132|NCT01753518|FG001|Participant Flow|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
11130133|NCT01753518|OG000|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
11130134|NCT01753518|OG001|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
11130135|NCT01753518|EG000|Reported Event|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
11130136|NCT01753518|EG001|Reported Event|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
11130137|NCT01753557|BG000|Baseline|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130138|NCT01753557|BG001|Baseline|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130139|NCT01753557|BG002|Baseline|Total|Total of all reporting groups
11130140|NCT01753557|FG000|Participant Flow|Treatment-Naive|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130141|NCT01753557|FG001|Participant Flow|Treatment-Relapsed|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130142|NCT01753557|OG000|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130143|NCT01753557|OG001|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130144|NCT01753557|OG000|Outcome|Treatment-Naïve|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130145|NCT01753557|EG000|Reported Event|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130146|NCT01753557|EG001|Reported Event|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
11130147|NCT01753570|BG000|Baseline|MP-424+RBV+IFN Beta, Genotype1|Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
11130148|NCT01753570|BG001|Baseline|RBV+IFN Beta, Genotype1|Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
11130149|NCT01753570|BG002|Baseline|MP-424+RBV+IFN Beta, Genotype2|Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
11130150|NCT01753570|BG003|Baseline|Total|Total of all reporting groups
11130151|NCT01753570|FG000|Participant Flow|MP-424+RBV+IFN Beta, Genotype1|Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
11130152|NCT01753570|FG001|Participant Flow|RBV+IFN Beta, Genotype1|Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
11130153|NCT01753570|FG002|Participant Flow|MP-424+RBV+IFN Beta, Genotype2|Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
11130154|NCT01753570|OG000|Outcome|MP-424+RBV+IFN Beta, Genotype1|Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
11130155|NCT01753570|OG001|Outcome|RBV+IFN Beta, Genotype1|Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
11130156|NCT01753570|OG002|Outcome|MP-424+RBV+IFN Beta, Genotype2|Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
11130157|NCT01753570|OG001|Outcome|MP-424+RBV+IFN Beta, Genotype2|Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
11130158|NCT01753570|EG000|Reported Event|MP-424+RBV+IFN Beta, Genotype1|"Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks"
11130159|NCT01753570|EG001|Reported Event|RBV+IFN Beta, Genotype1|"Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks"
11130160|NCT01753570|EG002|Reported Event|MP-424+RBV+IFN Beta, Genotype2|"Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks"
11130161|NCT01753713|BG000|Baseline|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11130162|NCT01753713|BG001|Baseline|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11130163|NCT01753713|BG002|Baseline|Total|Total of all reporting groups
11130164|NCT01753713|FG000|Participant Flow|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11130165|NCT01753713|FG001|Participant Flow|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11130166|NCT01753713|OG000|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11130167|NCT01753713|OG001|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11130168|NCT01753713|EG000|Reported Event|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11130169|NCT01753713|EG001|Reported Event|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11130170|NCT01753739|BG000|Baseline|Placebo|"Placebo nasal spray BID for 14 days~Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130171|NCT01753739|BG001|Baseline|Bepotastine Besilate 0.5%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11008675|NCT01097707|OG002|Outcome|10 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008676|NCT01097707|OG003|Outcome|25 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008677|NCT01097707|OG004|Outcome|Placebo|Placebo: Administered orally, daily for 24 weeks
11008678|NCT01097707|EG000|Reported Event|1 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008679|NCT01097707|EG001|Reported Event|3 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008680|NCT01097707|EG002|Reported Event|10 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008681|NCT01097707|EG003|Reported Event|25 mg LY500307|LY500307: Administered orally, daily for 24 weeks
11008682|NCT01097707|EG004|Reported Event|Placebo|Placebo: Administered orally, daily for 24 weeks
11008683|NCT01097785|BG000|Baseline|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
11008684|NCT01097785|BG001|Baseline|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
11008685|NCT01097785|BG002|Baseline|Total|Total of all reporting groups
11008686|NCT01097785|FG000|Participant Flow|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
11008687|NCT01097785|FG001|Participant Flow|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
11008688|NCT01097785|OG000|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
11008689|NCT01097785|OG001|Outcome|Placebo|Placebo cap 1 pill every day for 30 days
11008690|NCT01097785|OG001|Outcome|Placebo|"Placebo cap 1 pill every day for 30 days~Placebo: 1 capsule daily for 30 days"
11008691|NCT01097785|EG000|Reported Event|Simvastatin|"40 mg Simvastatin 1 pill every day for 30 days~Simvastatin: 40 mg, P.O.,daily for 30 days"
11008692|NCT01097785|EG001|Reported Event|Placebo|"Placebo cap 1 pill every day for 30 days~Placebo: 1 capsule daily for 30 days"
11008693|NCT01097863|BG000|Baseline|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
11008694|NCT01097863|BG001|Baseline|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
11008695|NCT01097863|BG002|Baseline|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
11008696|NCT01097863|BG003|Baseline|Total|Total of all reporting groups
11008697|NCT01097863|FG000|Participant Flow|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
11008698|NCT01097863|FG001|Participant Flow|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
11008699|NCT01097863|FG002|Participant Flow|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
11008700|NCT01097863|OG000|Outcome|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
11008701|NCT01097863|OG001|Outcome|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
11008702|NCT01097863|OG002|Outcome|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
11008703|NCT01097863|EG000|Reported Event|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
11008704|NCT01097863|EG001|Reported Event|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
11008705|NCT01097863|EG002|Reported Event|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
11008706|NCT01097915|BG000|Baseline|Super Tasters|Subjects highly sensitive to PROP
11008707|NCT01097915|BG001|Baseline|Medium Tasters|Subjects sensitive to PROP
11008708|NCT01097915|BG002|Baseline|Non Tasters|Subjects no sensitive to PROP
11008709|NCT01097915|BG003|Baseline|Total|Total of all reporting groups
11008710|NCT01097915|FG000|Participant Flow|Super Tasters|Subjects highly sensitive to PROP
11008711|NCT01097915|FG001|Participant Flow|Medium Tasters|Subjects sensitive to PROP
11008712|NCT01097915|FG002|Participant Flow|Non Tasters|Subjects no sensitive to PROP
11008713|NCT01097915|OG000|Outcome|Super Tasters|Subjects highly sensitive to PROP
11008714|NCT01097915|OG001|Outcome|Medium Tasters|Subjects sensitive to PROP
11008715|NCT01097915|OG002|Outcome|Non Tasters|Subjects no sensitive to PROP
11008716|NCT01097915|OG000|Outcome|Super-tasters|Subjects highly sensitive to PROP
11008717|NCT01097915|OG002|Outcome|Non-tasters|Subjects no sensitive to PROP
11008718|NCT01097915|OG000|Outcome|Super-Taster|Subjects highly sensitive to PROP
11008719|NCT01097915|OG001|Outcome|Medium Taster|Subjects sentitive to PROP
11008720|NCT01097915|OG002|Outcome|Non Taster|Subjects no sensitive to PROP
11008721|NCT01097915|OG000|Outcome|Primary Taste Quality|we taste Sucrose, NaCl, Citric Acid, Caffeine and MSG
11008722|NCT01097915|OG001|Outcome|Primary Taste Quality Supplemented With L-Arg|we taste Sucrose, NaCl, Citric Acid, Caffeine and MSG, each supplemented with L-Arginine (1:1)
11008723|NCT01097915|EG000|Reported Event|Super Tasters|Subjects highly sensitive to PROP
11008724|NCT01097915|EG001|Reported Event|Medium Tasters|Subjects sensitive to PROP
11008725|NCT01097915|EG002|Reported Event|Non Tasters|Subjects no sensitive to PROP
11130172|NCT01753739|BG002|Baseline|Bepotastine Besilate 1%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130173|NCT01753739|BG003|Baseline|Bepotastine Besilate 2%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130174|NCT01753739|BG004|Baseline|Bepotastine Besilate 4%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130175|NCT01753739|BG005|Baseline|Total|Total of all reporting groups
11130176|NCT01753739|FG000|Participant Flow|Placebo|"Placebo nasal spray BID for 14 days~Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130177|NCT01753739|FG001|Participant Flow|Bepotastine Besilate 0.5%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130178|NCT01753739|FG002|Participant Flow|Bepotastine Besilate 1%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130179|NCT01753739|FG003|Participant Flow|Bepotastine Besilate 2%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130180|NCT01753739|FG004|Participant Flow|Bepotastine Besilate 4%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130181|NCT01753739|OG000|Outcome|Placebo|"Placebo nasal spray BID for 14 days~Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130182|NCT01753739|OG001|Outcome|Bepotastine Besilate 0.5%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130183|NCT01753739|OG002|Outcome|Bepotastine Besilate 1%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130184|NCT01753739|OG003|Outcome|Bepotastine Besilate 2%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130185|NCT01753739|OG004|Outcome|Bepotastine Besilate 4%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130186|NCT01753739|EG000|Reported Event|Placebo|"Placebo nasal spray BID for 14 days~Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130187|NCT01753739|EG001|Reported Event|Bepotastine Besilate 0.5%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130188|NCT01753739|EG002|Reported Event|Bepotastine Besilate 1%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130189|NCT01753739|EG003|Reported Event|Bepotastine Besilate 2%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130190|NCT01753739|EG004|Reported Event|Bepotastine Besilate 4%|"Bepotastine besilate nasal spray, BID for 14 days.~Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days"
11130191|NCT01753830|BG000|Baseline|Durolane|"Single intraarticular injection of Durolane~Durolane"
11130192|NCT01753830|BG001|Baseline|Phosphate Buffered Saline (PBS)|"Single intraarticular injection of PBS~PBS"
11130193|NCT01753830|BG002|Baseline|Total|Total of all reporting groups
11130194|NCT01753830|FG000|Participant Flow|Durolane|"Single intraarticular injection of Durolane~Durolane"
11130195|NCT01753830|FG001|Participant Flow|Phosphate Buffered Saline (PBS)|"Single intraarticular injection of PBS~PBS"
11130196|NCT01753830|OG000|Outcome|Durolane|"Single intraarticular injection of Durolane~Durolane"
11130197|NCT01753830|OG001|Outcome|Phosphate Buffered Saline (PBS)|"Single intraarticular injection of PBS~PBS"
11130198|NCT01753830|EG000|Reported Event|Durolane|"Single intraarticular injection of Durolane~Durolane"
11130199|NCT01753830|EG001|Reported Event|Phosphate Buffered Saline (PBS)|"Single intraarticular injection of PBS~PBS"
11130200|NCT01753856|BG000|Baseline|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130201|NCT01753856|BG001|Baseline|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130202|NCT01753856|BG002|Baseline|Total|Total of all reporting groups
11226844|NCT02378480|OG000|Outcome|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 12 hours (q12h) (2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg oral administration q24h after a minimum of 3 days (6 doses) of IV treatment (6 overall IV doses because of the blinding). Participants received 4 active doses plus 2 placebo doses to maintain the blind. The total treatment duration was 7 to 14 days.
11130203|NCT01753856|FG000|Participant Flow|Teriparatide|"Teriparatide: 20-microgram (µg) subcutaneous (SC) injection once daily for 6 months.~DEM: 150-milligram (mg) tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 milligrams per day (mg/day) administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 International Units per day (IU/day) administered orally for 6 months."
11130204|NCT01753856|FG001|Participant Flow|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130205|NCT01753856|OG000|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130206|NCT01753856|OG001|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130207|NCT01753856|OG000|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130208|NCT01753856|OG001|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130209|NCT01753856|OG000|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130210|NCT01753856|EG000|Reported Event|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130211|NCT01753856|EG001|Reported Event|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
11130212|NCT01753999|BG000|Baseline|All Study Participants|Participants who were randomized to receive either standard CPAP or CPAP-Flex.
11130213|NCT01753999|FG000|Participant Flow|Standard CPAP Followed by CPAP-Flex|Participants were first treated with standard CPAP (continuous positive airway pressure with constant pressure) using a REMstar Auto A-flex in standard CPAP therapy mode for 4 weeks. The therapy mode was then switched to CPAP-Flex for 4 weeks. CPAP-Flex provides a decrease in pressure during expiration.
11130214|NCT01753999|FG001|Participant Flow|CPAP-Flex Followed by Standard CPAP|Participants were treated with CPAP-Flex (continuous positive airway pressure with a decrease in pressure during expiration) using a REMstar Auto A-flex in C-Flex mode for 4 weeks. The therapy mode was then switched to standard CPAP for 4 weeks. Standard CPAP provides a constant pressure (no decrease after expiration).
11130215|NCT01753999|OG000|Outcome|Standard CPAP|"Use of a standard CPAP (continuous positive airway pressure) device with constant pressure for 4 weeks to improve breathing during sleep~Standard CPAP: Use of the REMstar Auto A-Flex in standard CPAP therapy mode"
11130216|NCT01753999|OG001|Outcome|CPAP-Flex|"Use of CPAP-Flex (continuous positive airway pressure) device with decreased pressure during expiration for 4 weeks to improve breathing during sleep~CPAP - Flex: Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode"
11130217|NCT01753999|OG001|Outcome|CPAP - Flex|"Use of CPAP-Flex (continuous positive airway pressure) device with decreased pressure during expiration for 4 weeks to improve breathing during sleep~CPAP - Flex: Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode"
11130218|NCT01753999|OG000|Outcome|Standard CPAP|Participants were first treated with standard CPAP (continuous positive airway pressure with constant pressure) using a REMstar Auto A-flex in standard CPAP therapy either in the first treatment period or in the second treatment period.
11130219|NCT01753999|OG001|Outcome|CPAP-Flex|Participants were treated with CPAP-Flex (continuous positive airway pressure with a decrease in pressure during expiration) using a REMstar Auto A-flex in C-Flex either in the first treatment period or in the second treatment period.
11130220|NCT01753999|OG000|Outcome|Standard CPAP|Participants were treated with standard CPAP (continuous positive airway pressure with constant pressure) using a REMstar Auto A-flex in standard CPAP therapy either in the first treatment period or in the second treatment period.
11130221|NCT01753999|OG001|Outcome|CPAP - Flex|Participants were treated with CPAP-Flex (continuous airway pressure with a decrease in pressure during expiration) using a REMstar Auto A-flex in C-Flex either in the first treatment period or in the second treatment period.
11130222|NCT01753999|EG000|Reported Event|Standard CPAP|"Use of a standard CPAP (continuous positive airway pressure) device with constant pressure for 4 weeks to improve breathing during sleep~Standard CPAP: Use of the REMstar Auto A-Flex in standard CPAP therapy mode"
11130223|NCT01753999|EG001|Reported Event|CPAP - Flex|"Use of CPAP-Flex (continuous positive airway pressure) device with decreased pressure during expiration for 4 weeks to improve breathing during sleep~CPAP - Flex: Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode"
11130224|NCT01754129|BG000|Baseline|Participants With Parkinson's Disease|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130225|NCT01754129|FG000|Participant Flow|Participants With Parkinson's Disease|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130226|NCT01754129|OG000|Outcome|Participants With Parkinson's Disease|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130227|NCT01754129|OG000|Outcome|Participants With Parkinson's Disease- Visit 1|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130228|NCT01754129|OG001|Outcome|Participants With Parkinson's Disease- Visit 2|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130229|NCT01754129|OG002|Outcome|Partcipants With Parkinson's Disease- Visit 3|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130230|NCT01754129|OG000|Outcome|Participants With Parkinson's Disease- Baseline|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130231|NCT01754129|OG001|Outcome|Participants With Parkinson's Disease- Visit 1|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130232|NCT01754129|OG002|Outcome|Partcipants With Parkinson's Disease- Visit 2|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130233|NCT01754129|OG003|Outcome|Partcipants With Parkinson's Disease- Visit 3|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130234|NCT01754129|EG000|Reported Event|Participants With Parkinson's Disease|Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
11130235|NCT01754194|BG000|Baseline|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
11130236|NCT01754194|BG001|Baseline|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
11130237|NCT01754194|BG002|Baseline|Total|Total of all reporting groups
11130238|NCT01754194|FG000|Participant Flow|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
11130239|NCT01754194|FG001|Participant Flow|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
11130240|NCT01754194|OG000|Outcome|Procedure Type I|Gastric Sleeve Resection
11130241|NCT01754194|OG001|Outcome|Procedure Type II|Roux-en-Y Gastric Bypass
11130242|NCT01754194|OG000|Outcome|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
11130243|NCT01754194|OG001|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
11130244|NCT01754194|EG000|Reported Event|Procedure Type I|Gastric Sleeve Resection
11130245|NCT01754194|EG001|Reported Event|Procedure Type II|Roux-en-Y Gastric Bypass
11130246|NCT01754207|BG000|Baseline|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser~755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array"
11130247|NCT01754207|FG000|Participant Flow|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser"
11130248|NCT01754207|OG000|Outcome|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser~755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array"
11130249|NCT01754207|EG000|Reported Event|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser~755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array"
11130250|NCT01754259|BG000|Baseline|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
11130251|NCT01754259|BG001|Baseline|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
11130252|NCT01754259|BG002|Baseline|Total|Total of all reporting groups
11130253|NCT01754259|FG000|Participant Flow|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
11130254|NCT01754259|FG001|Participant Flow|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
11130255|NCT01754259|OG000|Outcome|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
11130256|NCT01754259|OG001|Outcome|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
11130257|NCT01754259|EG000|Reported Event|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
11130258|NCT01754259|EG001|Reported Event|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
11130259|NCT01754350|BG000|Baseline|Ketogenic Diet and Transient Fasting|"Calorie-restricted, ketogenic diet and transient fasting during reirradiation~calorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by Tavarlin."
11130260|NCT01754350|BG001|Baseline|Standard Nutrition|"nutrition according to recommendations of the German society for nutrition during reirradiation~standard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day"
11130261|NCT01754350|BG002|Baseline|Total|Total of all reporting groups
11130262|NCT01754350|FG000|Participant Flow|Ketogenic Diet and Transient Fasting|"Calorie-restricted, ketogenic diet and transient fasting during reirradiation~calorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by Tavarlin."
11130263|NCT01754350|FG001|Participant Flow|Standard Nutrition|"nutrition according to recommendations of the German society for nutrition during reirradiation~standard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day"
11130264|NCT01754350|OG000|Outcome|Ketogenic Diet and Transient Fasting|"Calorie-restricted, ketogenic diet and transient fasting during reirradiation~calorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by Tavarlin."
11130265|NCT01754350|OG001|Outcome|Standard Nutrition|"nutrition according to recommendations of the German society for nutrition during reirradiation~standard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day"
11130266|NCT01754350|EG000|Reported Event|Ketogenic Diet and Transient Fasting|"Calorie-restricted, ketogenic diet and transient fasting during reirradiation~calorie-restricted ketogenic diet and transient fasting: On day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by Tavarlin."
11130267|NCT01754350|EG001|Reported Event|Standard Nutrition|"nutrition according to recommendations of the German society for nutrition during reirradiation~standard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day"
11130268|NCT01754376|BG000|Baseline|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
11130269|NCT01754376|FG000|Participant Flow|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
11130270|NCT01754376|OG000|Outcome|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
11130271|NCT01754376|OG000|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
11130272|NCT01754376|EG000|Reported Event|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
11130273|NCT01754389|BG000|Baseline|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
11130274|NCT01754389|BG001|Baseline|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant~Bortezomib"
11130275|NCT01754389|BG002|Baseline|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant~Sirolimus"
11130276|NCT01754389|BG003|Baseline|Total|Total of all reporting groups
11130277|NCT01754389|FG000|Participant Flow|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
11130278|NCT01754389|FG001|Participant Flow|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
11130279|NCT01754389|FG002|Participant Flow|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
11130280|NCT01754389|OG000|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
11130281|NCT01754389|OG001|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
11130282|NCT01754389|OG002|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
11130283|NCT01754389|EG000|Reported Event|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
11130284|NCT01754389|EG001|Reported Event|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
10849019|NCT00293254|EG001|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
11130285|NCT01754389|EG002|Reported Event|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
11130286|NCT01754402|BG000|Baseline|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
11130287|NCT01754402|BG001|Baseline|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
11130288|NCT01754402|BG002|Baseline|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
11130289|NCT01754402|BG003|Baseline|Total|Total of all reporting groups
11130290|NCT01754402|FG000|Participant Flow|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
11226845|NCT02378480|OG001|Outcome|Linezolid|Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days.
10849020|NCT00293267|BG000|Baseline|Raltegravir 400 mg b.i.d. + OBT|
10849021|NCT00293267|BG001|Baseline|Placebo + OBT|
10849022|NCT00293267|BG002|Baseline|Total|Total of all reporting groups
11130291|NCT01754402|FG001|Participant Flow|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
11130292|NCT01754402|FG002|Participant Flow|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
11130293|NCT01754402|OG000|Outcome|Cohorts 1 and 2|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation)~Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles.~Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.~Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,"
11130294|NCT01754402|OG000|Outcome|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
11130295|NCT01754402|OG001|Outcome|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
11130296|NCT01754402|OG002|Outcome|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
11130297|NCT01754402|EG000|Reported Event|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
11130298|NCT01754402|EG001|Reported Event|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
11130299|NCT01754402|EG002|Reported Event|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
11130300|NCT01754467|BG000|Baseline|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
11130301|NCT01754467|FG000|Participant Flow|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
11130302|NCT01754467|OG000|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
11130303|NCT01754467|EG000|Reported Event|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
11130304|NCT01754480|BG000|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
11130305|NCT01754480|BG001|Baseline|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
11130306|NCT01754480|BG002|Baseline|Total|Total of all reporting groups
11130307|NCT01754480|FG000|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
11130308|NCT01754480|FG001|Participant Flow|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
11130309|NCT01754480|OG000|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
11130310|NCT01754480|OG001|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
11130311|NCT01754480|OG000|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
11130312|NCT01754480|EG000|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
11130313|NCT01754480|EG001|Reported Event|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
11130314|NCT01754493|BG000|Baseline|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
11130315|NCT01754493|FG000|Participant Flow|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
11130316|NCT01754493|OG000|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
11130317|NCT01754493|EG000|Reported Event|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
11130318|NCT01754519|BG000|Baseline|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11130319|NCT01754519|FG000|Participant Flow|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11130320|NCT01754519|OG000|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11130321|NCT01754519|EG000|Reported Event|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11130322|NCT01754623|BG000|Baseline|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
11130323|NCT01754623|FG000|Participant Flow|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
11130324|NCT01754623|OG000|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
11130325|NCT01754623|OG000|Outcome|All Participants -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
11130326|NCT01754623|OG001|Outcome|Resection Group -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
11130327|NCT01754623|EG000|Reported Event|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
11130328|NCT01754688|BG000|Baseline|Neonates|
11130329|NCT01754688|FG000|Participant Flow|Neonates|observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
11130330|NCT01754688|OG000|Outcome|Neonates|observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
11130331|NCT01754688|OG000|Outcome|Neonates|
11130332|NCT01754688|EG000|Reported Event|Neonates|observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
11130333|NCT01754714|BG000|Baseline|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
11130334|NCT01754714|BG001|Baseline|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
11130335|NCT01754714|BG002|Baseline|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
11130336|NCT01754714|BG003|Baseline|No Treatment|no study drug was administered
11130337|NCT01754714|BG004|Baseline|Total|Total of all reporting groups
11130338|NCT01754714|FG000|Participant Flow|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
11130339|NCT01754714|FG001|Participant Flow|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
11130340|NCT01754714|FG002|Participant Flow|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
11130341|NCT01754714|FG003|Participant Flow|No Treatment|No study drug was administered
11130342|NCT01754714|OG000|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
11226846|NCT02378480|EG000|Reported Event|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 12 hours (q12h) (2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg oral administration q24h after a minimum of 3 days (6 doses) of IV treatment (6 overall IV doses because of the blinding). Participants received 4 active doses plus 2 placebo doses to maintain the blind. The total treatment duration was 7 to 14 days.
10849023|NCT00293267|FG000|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
11130343|NCT01754714|OG001|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
11130344|NCT01754714|OG002|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
11130345|NCT01754714|OG003|Outcome|No Treatment|No study drug was administered
11130346|NCT01754714|OG003|Outcome|No Treatment|
11130347|NCT01754714|EG000|Reported Event|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
11130348|NCT01754714|EG001|Reported Event|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
11130349|NCT01754714|EG002|Reported Event|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
11130350|NCT01754714|EG003|Reported Event|No Treatment|No study drug was administered
11130351|NCT01754727|BG000|Baseline|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
11130352|NCT01754727|FG000|Participant Flow|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
11130353|NCT01754727|OG000|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
11130354|NCT01754727|EG000|Reported Event|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
11130355|NCT01754753|BG000|Baseline|Telephone Friendship Groups|"Participants allocated to telephone friendship groups will take part in 12 weekly group telephone discussions. The participant will be called, by a trained Age UK Sheffield volunteer, in their own home. The group discussions will take place for about an hour each week and involve between 6-8 participants. Participants will be introduced to weekly group calls by the volunteer who will call each participant individually for around 20 minutes each week for up to six weeks before the group is established.~The group may have a particular focus or talk about different topics each week. The individual participants are joined together through a teleconferencing system (provided by Community Network).~Telephone Friendship groups"
11130356|NCT01754753|BG001|Baseline|Usual Health and Social Care|Participants allocated to the control arm will not receive any research intervention. However, they will participate in the research by completing questionnaires about their health and wellbeing.
11130357|NCT01754753|BG002|Baseline|Total|Total of all reporting groups
11130358|NCT01754753|FG000|Participant Flow|Telephone Friendship Groups|"Participants allocated to telephone friendship groups will take part in 12 weekly group telephone discussions. The participant will be called, by a trained Age UK Sheffield volunteer, in their own home. The group discussions will take place for about an hour each week and involve between 6-8 participants. Participants will be introduced to weekly group calls by the volunteer who will call each participant individually for around 20 minutes each week for up to six weeks before the group is established.~The group may have a particular focus or talk about different topics each week. The individual participants are joined together through a teleconferencing system (provided by Community Network).~Telephone Friendship groups"
11130359|NCT01754753|FG001|Participant Flow|Usual Health and Social Care|Participants allocated to the control arm will not receive any research intervention. However, they will participate in the research by completing questionnaires about their health and wellbeing.
11130360|NCT01754753|OG000|Outcome|Telephone Friendship Groups|"Participants allocated to telephone friendship groups will take part in 12 weekly group telephone discussions. The participant will be called, by a trained Age UK Sheffield volunteer, in their own home. The group discussions will take place for about an hour each week and involve between 6-8 participants. Participants will be introduced to weekly group calls by the volunteer who will call each participant individually for around 20 minutes each week for up to six weeks before the group is established.~The group may have a particular focus or talk about different topics each week. The individual participants are joined together through a teleconferencing system (provided by Community Network).~Telephone Friendship groups"
11130361|NCT01754753|OG001|Outcome|Usual Health and Social Care|Participants allocated to the control arm will not receive any research intervention. However, they will participate in the research by completing questionnaires about their health and wellbeing.
11130362|NCT01754753|EG000|Reported Event|Telephone Friendship Groups|"Participants allocated to telephone friendship groups will take part in 12 weekly group telephone discussions. The participant will be called, by a trained Age UK Sheffield volunteer, in their own home. The group discussions will take place for about an hour each week and involve between 6-8 participants. Participants will be introduced to weekly group calls by the volunteer who will call each participant individually for around 20 minutes each week for up to six weeks before the group is established.~The group may have a particular focus or talk about different topics each week. The individual participants are joined together through a teleconferencing system (provided by Community Network).~Telephone Friendship groups"
11130363|NCT01754753|EG001|Reported Event|Usual Health and Social Care|Participants allocated to the control arm will not receive any research intervention. However, they will participate in the research by completing questionnaires about their health and wellbeing.
11130364|NCT01754766|BG000|Baseline|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
11130365|NCT01754766|BG001|Baseline|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
11130366|NCT01754766|BG002|Baseline|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
11130367|NCT01754766|BG003|Baseline|Total|Total of all reporting groups
11130368|NCT01754766|FG000|Participant Flow|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
11130369|NCT01754766|FG001|Participant Flow|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
11130370|NCT01754766|FG002|Participant Flow|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
11130371|NCT01754766|OG000|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
11130372|NCT01754766|OG001|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
11130373|NCT01754766|OG002|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
11130374|NCT01754766|EG000|Reported Event|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
11130375|NCT01754766|EG001|Reported Event|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
11130376|NCT01754766|EG002|Reported Event|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
11130377|NCT01754909|BG000|Baseline|Enalapril|"Use of enalapril in subjects undergoing radiotherapy for lung cancer.~Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer"
11130378|NCT01754909|BG001|Baseline|Placebo|"Use of placebo in subjects undergoing radiotherapy for lung cancer~placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer"
11130379|NCT01754909|BG002|Baseline|Total|Total of all reporting groups
11130380|NCT01754909|FG000|Participant Flow|Enalapril|"Use of enalapril in subjects undergoing radiotherapy for lung cancer.~Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer"
11130381|NCT01754909|FG001|Participant Flow|Placebo|"Use of placebo in subjects undergoing radiotherapy for lung cancer~placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer"
11130382|NCT01754909|OG000|Outcome|Enalapril|"Use of enalapril in subjects undergoing radiotherapy for lung cancer.~Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer"
11130383|NCT01754909|OG001|Outcome|Placebo|"Use of placebo in subjects undergoing radiotherapy for lung cancer~placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer"
11130384|NCT01754909|EG000|Reported Event|Enalapril|"Use of enalapril in subjects undergoing radiotherapy for lung cancer.~Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer"
11130385|NCT01754909|EG001|Reported Event|Placebo|"Use of placebo in subjects undergoing radiotherapy for lung cancer~placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer"
11130386|NCT01754922|BG000|Baseline|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
11130387|NCT01754922|BG001|Baseline|Control|Veterans deployed to regions other than Iraq or Afghanistan or non-deployed
11130388|NCT01754922|BG002|Baseline|Total|Total of all reporting groups
11130389|NCT01754922|FG000|Participant Flow|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
11130390|NCT01754922|FG001|Participant Flow|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
11130391|NCT01754922|OG000|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
11130392|NCT01754922|OG001|Outcome|Control|Veterans deployed to regions other than Iraq and Afghanistan or non-deployed
11130393|NCT01754922|OG001|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
11130394|NCT01754922|EG000|Reported Event|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
11130395|NCT01754922|EG001|Reported Event|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia or non-deployed
11130396|NCT01755026|BG000|Baseline|4 Gram Dose|4 gram dose of pre-operative prophylaxis
11130397|NCT01755026|BG001|Baseline|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
11130398|NCT01755026|BG002|Baseline|Total|Total of all reporting groups
11130399|NCT01755026|FG000|Participant Flow|4 Gram Dose|4 gram dose of pre-operative prophylaxis
11130400|NCT01755026|FG001|Participant Flow|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
11130401|NCT01755026|OG000|Outcome|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
11130402|NCT01755026|OG001|Outcome|4 Gram Dose|4 gram dose of pre-operative prophylaxis
11130403|NCT01755026|EG000|Reported Event|4 Gram Dose|4 gram dose of pre-operative prophylaxis
11130404|NCT01755026|EG001|Reported Event|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
11130405|NCT01755091|BG000|Baseline|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
11130406|NCT01755091|BG001|Baseline|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
11130407|NCT01755091|BG002|Baseline|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
11130408|NCT01755091|BG003|Baseline|Total|Total of all reporting groups
11130409|NCT01755091|FG000|Participant Flow|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
11130410|NCT01755091|FG001|Participant Flow|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
11130411|NCT01755091|FG002|Participant Flow|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
11130412|NCT01755091|OG000|Outcome|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
11130413|NCT01755091|OG001|Outcome|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
11130414|NCT01755091|OG002|Outcome|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
11130415|NCT01755091|EG000|Reported Event|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
11130416|NCT01755091|EG001|Reported Event|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
11130417|NCT01755091|EG002|Reported Event|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
11226847|NCT02378480|EG001|Reported Event|Linezolid|Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days.
11130418|NCT01755143|BG000|Baseline|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
11130419|NCT01755143|BG001|Baseline|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
11130420|NCT01755143|BG002|Baseline|Total|Total of all reporting groups
11130421|NCT01755143|FG000|Participant Flow|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
10849024|NCT00293267|FG001|Participant Flow|Placebo + OBT|
11130422|NCT01755143|FG001|Participant Flow|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
11130423|NCT01755143|OG000|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
11130424|NCT01755143|OG001|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
11130425|NCT01755143|EG000|Reported Event|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
11130426|NCT01755143|EG001|Reported Event|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
11130427|NCT01755156|BG000|Baseline|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
11130428|NCT01755156|BG001|Baseline|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
11130429|NCT01755156|BG002|Baseline|Total|Total of all reporting groups
11130430|NCT01755156|FG000|Participant Flow|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
11130431|NCT01755156|FG001|Participant Flow|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
11130432|NCT01755156|OG000|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
11130433|NCT01755156|OG001|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
11130434|NCT01755156|OG000|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
11130435|NCT01755156|OG001|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
11130436|NCT01755156|EG000|Reported Event|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
11130437|NCT01755156|EG001|Reported Event|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks.
11130438|NCT01755156|EG002|Reported Event|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
11130439|NCT01755156|EG003|Reported Event|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
11130440|NCT01755169|BG000|Baseline|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130441|NCT01755169|BG001|Baseline|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130442|NCT01755169|BG002|Baseline|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130443|NCT01755169|BG003|Baseline|Placebo|Placebo
11130444|NCT01755169|BG004|Baseline|Total|Total of all reporting groups
11130445|NCT01755169|FG000|Participant Flow|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130446|NCT01755169|FG001|Participant Flow|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130447|NCT01755169|FG002|Participant Flow|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130448|NCT01755169|FG003|Participant Flow|Placebo|Placebo
11130449|NCT01755169|OG000|Outcome|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130450|NCT01755169|OG001|Outcome|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130451|NCT01755169|OG002|Outcome|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130452|NCT01755169|OG003|Outcome|Placebo|Placebo
11130453|NCT01755169|EG000|Reported Event|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130454|NCT01755169|EG001|Reported Event|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130455|NCT01755169|EG002|Reported Event|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
11130456|NCT01755169|EG003|Reported Event|Placebo|Placebo
11130457|NCT01755195|BG000|Baseline|Cabozantinib|"60 mg tablets orally once a day in a 28-day cycle.~Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2)."
11130458|NCT01755195|FG000|Participant Flow|Cabozantinib|"60 mg tablets orally once a day in a 28-day cycle.~Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2)."
11130459|NCT01755195|OG000|Outcome|Cabozantinib|"60 mg tablets orally once a day in a 28-day cycle.~Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2)."
11130460|NCT01755195|EG000|Reported Event|Cabozantinib|"60 mg tablets orally once a day in a 28-day cycle.~Cabozantinib: Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2)."
11130461|NCT01755234|BG000|Baseline|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
11130462|NCT01755234|BG001|Baseline|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
11130463|NCT01755234|BG002|Baseline|Total|Total of all reporting groups
11130464|NCT01755234|FG000|Participant Flow|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
11130465|NCT01755234|FG001|Participant Flow|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
11130466|NCT01755234|OG000|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
11130467|NCT01755234|OG001|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
11130468|NCT01755234|EG000|Reported Event|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
11130469|NCT01755234|EG001|Reported Event|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
11130470|NCT01755416|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Closed Loop/Insulin subcutaneously or Closed Loop /Insulin/Liraglutide; 1.2 mg of Liraglutide subcutaneously as a single daily injection and insulin as a continuous subcutaneous infusion
11130471|NCT01755416|FG000|Participant Flow|Closed Loop/Insulin First,Then Closed Loop/Insulin/Liraglutide|Participants underwent Closed Loop with Insulin first, as a continuous subcutaneous infusion for 2 days. Then they underwent the closed loop with Insulin and Liraglutide; insulin as a continuous subcutaneous infusion and liraglutide as a single daily subcutaneous injection of 1.2 mg for the next 2 days. Each visit is 10 days apart.
11130472|NCT01755416|FG001|Participant Flow|Closed Loop/Insulin/Liraglutide First,Then Closed Loop/Insulin|Participants underwent Closed Loop with Insulin and Liraglutide first, insulin as a continuous subcutaneous infusion and liraglutide as a single daily subcutaneous injection of 1.2 mg for the first 2 days. Then they underwent the closed loop with Insulin alone, as a continuous subcutaneous infusion for the next 2 days. Each visit is 10 days apart.
11130473|NCT01755416|OG000|Outcome|Closed Loop/Insulin|Participants on Closed Loop with Insulin as a continuous subcutaneous infusion for 2 days
11130474|NCT01755416|OG001|Outcome|Closed Loop/Insulin/Liraglutide|Participants on Closed Loop with Insulin and Liraglutide, insulin as a continuous subcutaneous infusion and Liraglutide as a single daily subcutaneous injection of 1.2 mg for 2 days
11130475|NCT01755416|EG000|Reported Event|Closed Loop/Insulin|Participants on Closed Loop with Insulin as a continuous subcutaneous infusion for 2 days.
11130476|NCT01755416|EG001|Reported Event|Closed Loop/Insulin/Liraglutide|Participants on Closed Loop with Insulin and Liraglutide, insulin as a continuous subcutaneous infusion and Liraglutide as a single daily subcutaneous injection of 1.2 mg for 2 days
11130477|NCT01755455|BG000|Baseline|All Study Participants|Includes those who started the study with First Intervention and those who started the study with Second Intervention
11130478|NCT01755455|FG000|Participant Flow|Placebo, Then Ferrous Sulfate|Placebo administered daily for 6 week followed by 4-week washout, then Ferrous Sulfate 325 mg administered daily for 6 weeks.
11130479|NCT01755455|FG001|Participant Flow|Ferrous Sulfate, Then Placebo|Ferrous Sulfate 325 mg administered daily for 6 weeks followed by 4-week washout, then Placebo administered daily for 6 weeks.
11130480|NCT01755455|OG000|Outcome|Placebo|Outcome measure in all participants who received placebo.
10849025|NCT00293267|OG000|Outcome|Raltegravir 400 mg b.i.d. + OBT|
10849026|NCT00293267|OG001|Outcome|Placebo + OBT|
11130481|NCT01755455|OG001|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
11130482|NCT01755455|EG000|Reported Event|Placebo|Events observed among all participants while they were receiving placebo.
11130483|NCT01755455|EG001|Reported Event|Ferrous Sulfate|Events observed among all participants while they were receiving ferrous sulfate.
11130484|NCT01755546|BG000|Baseline|Overall|All subjects combined, Roll Over and De-Novo.
11130485|NCT01755546|FG000|Participant Flow|Overall|All subjects combined, Roll Over and De Novo.
11130486|NCT01755546|OG000|Outcome|Overall|All subjects combined, Roll Over and De-Novo.
11130487|NCT01755546|EG000|Reported Event|Overall|All subjects combined, Roll Over and De-Novo.
11130488|NCT01755598|BG000|Baseline|M72AS01 Group|Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
11130489|NCT01755598|BG001|Baseline|Control Group|Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
11130490|NCT01755598|BG002|Baseline|Total|Total of all reporting groups
11130491|NCT01755598|FG000|Participant Flow|M72AS01 Group|Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
11130492|NCT01755598|FG001|Participant Flow|Control Group|Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
11130493|NCT01755598|OG000|Outcome|M72AS01 Group|Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
11130494|NCT01755598|OG001|Outcome|Control Group|Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
11130495|NCT01755598|EG000|Reported Event|M72AS01 Group|Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
11130496|NCT01755598|EG001|Reported Event|Control Group|Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
11130497|NCT01755637|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
11130498|NCT01755637|FG000|Participant Flow|Albendazole (Aqua) First, Then Albendazole (Alcohol)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment, followed by single dose treatment of 400 mg albendazole tablets manufactured under ethanol based solvent conditions. A wash-out period of 7 days was maintained between treatment periods.
11130499|NCT01755637|FG001|Participant Flow|Albendazole (Alcohol) First, Then Albendazole (Aqua)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment followed by 400 mg aqua based albendazole tablets. A wash-out period of 7 days was maintained between treatment periods.
11130500|NCT01755637|OG000|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
11130501|NCT01755637|OG001|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
11130502|NCT01755637|OG000|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
11130503|NCT01755637|OG000|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
11130504|NCT01755637|OG001|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
11130505|NCT01755637|OG000|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
11130506|NCT01755637|OG000|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole Sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
11130507|NCT01755637|OG001|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole Sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
11130508|NCT01755637|EG000|Reported Event|Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
11130509|NCT01755637|EG001|Reported Event|Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
11130510|NCT01755702|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
11130511|NCT01755702|FG000|Participant Flow|Overall|"In this cross-over study, participants were randomly-assigned to a blinded treatment sequence. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes.~The following treatments were administered during the study.~1000/130mg paracetamol/caffeine (two 500/65mg caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approximately (approx.) 250 ml of water.~1000mg paracetamol (two 500mg caplets) plus placebo paracetamol/caffeine (two caplets) taken orally with approx. 250 ml of water.~400mg ibuprofen (two 200mg caplets) plus placebo paracetamol/caffeine (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.~placebo paracetamol/caffeine (two caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approx. 250 ml of water."
11130512|NCT01755702|OG000|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
11130513|NCT01755702|OG001|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
11130514|NCT01755702|OG002|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
11130515|NCT01755702|OG003|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
11130516|NCT01755702|EG000|Reported Event|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
11130517|NCT01755702|EG001|Reported Event|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
11130518|NCT01755702|EG002|Reported Event|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
11130519|NCT01755702|EG003|Reported Event|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
11130520|NCT01755767|BG000|Baseline|Tivantinib 240 mg BID Cohort|Participants who received tivantinib 240 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 480 mg.
11130521|NCT01755767|BG001|Baseline|Placebo Matching 240 mg BID Cohort|Participants who received matching placebo tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food.
11130522|NCT01755767|BG002|Baseline|Tivantinib 120 mg BID Cohort|Participants who received tivantinib 120 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 240 mg (amended dosing group; primary analysis group).
11130523|NCT01755767|BG003|Baseline|Placebo Matching 120 mg BID Cohort|Participants who received matching placebo tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food.
11130524|NCT01755767|BG004|Baseline|Total|Total of all reporting groups
11130525|NCT01755767|FG000|Participant Flow|Tivantinib 240 mg BID Cohort|Participants who received tivantinib 240 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 480 mg.
11130526|NCT01755767|FG001|Participant Flow|Placebo Matching 240 mg BID Cohort|Participants who received matching placebo tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food.
11130527|NCT01755767|FG002|Participant Flow|Tivantinib 120 mg BID Cohort|Participants who received tivantinib 120 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 240 mg (amended dosing group; primary analysis group).
11130528|NCT01755767|FG003|Participant Flow|Placebo Matching 120 mg BID Cohort|Participants who received matching placebo tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food.
11130529|NCT01755767|OG000|Outcome|Tivantinib 120 mg BID Cohort|Participants who received tivantinib 120 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 240 mg (amended dosing group; primary analysis group).
10849027|NCT00293267|OG000|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
11130530|NCT01755767|OG001|Outcome|Placebo Matching 120 mg BID Cohort|Participants who received matching placebo tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food.
11130531|NCT01755767|OG000|Outcome|Tivantinib 240 mg BID Cohort|Participants who received tivantinib 240 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 480 mg (amended dosing group; primary analysis group).
11130532|NCT01755767|OG001|Outcome|Placebo Matching 240 mg BID Cohort|Participants who received matching placebo tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food.
11130533|NCT01755767|EG000|Reported Event|Tivantinib 240 mg BID Cohort|Participants who received tivantinib 240 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 480 mg.
11130534|NCT01755767|EG001|Reported Event|Placebo Matching 240 mg BID Cohort|Participants who received matching placebo tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food.
11130535|NCT01755767|EG002|Reported Event|Tivantinib 120 mg BID Cohort|Participants who received tivantinib 120 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 240 mg (amended dosing group; primary analysis group).
11130536|NCT01755767|EG003|Reported Event|Placebo Matching 120 mg BID Cohort|Participants who received matching placebo tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food.
11130537|NCT01755858|BG000|Baseline|Bendavia|Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
11130538|NCT01755858|BG001|Baseline|Placebo|Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
11130539|NCT01755858|BG002|Baseline|Total|Total of all reporting groups
11130540|NCT01755858|FG000|Participant Flow|Bendavia|Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
11130541|NCT01755858|FG001|Participant Flow|Placebo|Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
11130542|NCT01755858|OG000|Outcome|Bendavia|Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
11130543|NCT01755858|OG001|Outcome|Placebo|Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
11130544|NCT01755858|OG000|Outcome|Bendavia|"Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.~Bendavia"
11130545|NCT01755858|OG001|Outcome|Placebo|"Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.~Placebo"
11130546|NCT01755858|EG000|Reported Event|Bendavia|Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
11130547|NCT01755858|EG001|Reported Event|Placebo|Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
11130548|NCT01755949|BG000|Baseline|Chronic Atrial Fibrillation, Colchicine|"Colchicine 0.6 mg PO BID~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects not undergoing ablation."
10849028|NCT00293267|OG001|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
11130549|NCT01755949|BG001|Baseline|Chronic Atrial Fibrillation, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects not undergoing ablation."
11130550|NCT01755949|BG002|Baseline|Pre-ablation, Sinus Rhythm, Colchicine|"Colchicine 0.6 mg PO BID~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation."
11130551|NCT01755949|BG003|Baseline|Pre-ablation, Sinus Rhythm, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects undergoing ablation."
11130552|NCT01755949|BG004|Baseline|Pre-ablation, AF, Colchicine|"Colchicine 0.6 mg PO BID~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation."
11130553|NCT01755949|BG005|Baseline|Pre-ablation, AF, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects undergoing ablation."
11130554|NCT01755949|BG006|Baseline|Total|Total of all reporting groups
11130555|NCT01755949|FG000|Participant Flow|Chronic Atrial Fibrillation, Colchicine|"Colchicine 0.6 mg PO bis in die (BID)~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo~Subjects not undergoing ablation."
11130556|NCT01755949|FG001|Participant Flow|Chronic Atrial Fibrillation, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug~Subjects not undergoing ablation."
11130557|NCT01755949|FG002|Participant Flow|Pre-ablation, Sinus Rhythm, Colchicine|"Colchicine 0.6 mg PO BID~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation."
11130558|NCT01755949|FG003|Participant Flow|Pre-ablation, Sinus Rhythm, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug~Subjects undergoing ablation."
11130559|NCT01755949|FG004|Participant Flow|Pre-ablation, AF, Colchicine|"Colchicine 0.6 mg PO BID~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo~Subjects undergoing ablation."
11130560|NCT01755949|FG005|Participant Flow|Pre-ablation, AF, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug~Subjects undergoing ablation."
11130561|NCT01755949|OG000|Outcome|Chronic Atrial Fibrillation, Colchicine|Colchicine 0.6 mg, twice daily for 28 days Subjects not undergoing ablation.
11130562|NCT01755949|OG001|Outcome|Chronic Atrial Fibrillation, Placebo|Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects not undergoing ablation.
11130563|NCT01755949|OG002|Outcome|Pre-ablation, Sinus Rhythm, Colchicine|Colchicine 0.6 mg, twice daily for 28 days Subjects undergoing ablation.
11130564|NCT01755949|OG003|Outcome|Pre-ablation, Sinus Rhythm, Placebo|Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects undergoing ablation.
11130565|NCT01755949|OG004|Outcome|Pre-ablation, AF, Colchicine|Colchicine 0.6 mg, twice daily for 28 days Subjects undergoing ablation.
11130566|NCT01755949|OG005|Outcome|Pre-ablation, AF, Placebo|Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects undergoing ablation.
11130567|NCT01755949|EG000|Reported Event|Chronic Atrial Fibrillation, Colchicine|"Colchicine 0.6 mg PO BID~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects not undergoing ablation."
11130568|NCT01755949|EG001|Reported Event|Chronic Atrial Fibrillation, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects not undergoing ablation."
11130569|NCT01755949|EG002|Reported Event|Pre-ablation, Sinus Rhythm, Colchicine|"Colchicine 0.6 mg PO BID~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation."
11130570|NCT01755949|EG003|Reported Event|Pre-ablation, Sinus Rhythm, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects undergoing ablation."
11130571|NCT01755949|EG004|Reported Event|Pre-ablation, AF, Colchicine|"Colchicine 0.6 mg PO BID~Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation."
11130572|NCT01755949|EG005|Reported Event|Pre-ablation, AF, Placebo|"Matching placebo~Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects undergoing ablation."
11130573|NCT01756053|BG000|Baseline|All Study Subjects|Subjects who were randomized and received their Period 1 study medication (ABT-089 or matching placebo).
11130574|NCT01756053|FG000|Participant Flow|ABT-089, Then Placebo|"Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four capsules of matching placebo daily for a second 10-day medication period.~ABT-089: Selective neuronal nicotinic receptor agonist."
11130575|NCT01756053|FG001|Participant Flow|Placebo, Then ABT-089|"Those randomized to placebo (matching ABT-089 10 mg capsules) during study medication period 1 will take four capsules daily during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four 10 mg capsules (40 mg) daily of ABT-089 for a second 10-day study medication period.~Placebo: Matching placebo capsules supplied by study drug supplier."
11130576|NCT01756053|OG000|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
11130577|NCT01756053|OG001|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
11130578|NCT01756053|EG000|Reported Event|ABT-089|"Subjects were assigned to take four 10 mg capsules daily (40 mg daily) during a 10-day medication period.~ABT-089: Selective neuronal nicotinic receptor agonist."
11130579|NCT01756053|EG001|Reported Event|Placebo|"Subjects were assigned to take four placebo capsules (matching ABT-089 10 mg) daily during a 10-day medication period.~Placebo: Matched placebo capsules supplied by study drug supplier."
11130580|NCT01756079|BG000|Baseline|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
11130581|NCT01756079|FG000|Participant Flow|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
11130582|NCT01756079|OG000|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
11130583|NCT01756079|OG000|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
11130584|NCT01756079|EG000|Reported Event|Overall Participants: Lead-in, Treatment and Follow-up|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
11130585|NCT01756157|BG000|Baseline|Entire Study Population|Included participants who received 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment A) first and 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment B) first.
11130586|NCT01756157|FG000|Participant Flow|Treatment Sequence A/B|Participants received Treatment A in Period 1 and Treatment B in Period 2; for 8 weeks each as a single 20 milliliter (mL) subcutaneous (SC) injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2. Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks. Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.
11130587|NCT01756157|FG001|Participant Flow|Treatment Sequence B/A|Participants received Treatment B in Period 1 and Treatment A in Period 2; for 8 weeks each as a single 20 mL SC injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2. Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks. Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.
11130588|NCT01756157|OG000|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
11130589|NCT01756157|OG001|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
11130590|NCT01756157|EG000|Reported Event|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
11130591|NCT01756157|EG001|Reported Event|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
11130592|NCT01756209|BG000|Baseline|Acetaminophen|Acetaminophen 15 mg/kg oral single dose
11130593|NCT01756209|BG001|Baseline|Ibuprofen|Ibuprofen 10 mg/kg oral single dose
11130594|NCT01756209|BG002|Baseline|Mg + Acetaminophen|Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose
11130595|NCT01756209|BG003|Baseline|Mg + Ibuprofen|Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
11130596|NCT01756209|BG004|Baseline|Total|Total of all reporting groups
11130597|NCT01756209|FG000|Participant Flow|Acetaminophen|Acetaminophen 15 mg/kg oral single dose
11130598|NCT01756209|FG001|Participant Flow|Ibuprofen|Ibuprofen 10 mg/kg oral single dose
11130599|NCT01756209|FG002|Participant Flow|Mg + Acetaminophen|Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose
11130600|NCT01756209|FG003|Participant Flow|Mg + Ibuprofen|Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
11130601|NCT01756209|OG000|Outcome|Acetaminophen|Acetaminophen 15 mg/kg oral single dose
11130602|NCT01756209|OG001|Outcome|Ibuprofen|Ibuprofen 10 mg/kg oral single dose
11130603|NCT01756209|OG002|Outcome|Mg + Acetaminophen|Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose
11130604|NCT01756209|OG003|Outcome|Mg + Ibuprofen|Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
11130605|NCT01756209|EG000|Reported Event|Acetaminophen|Acetaminophen 15 mg/kg oral single dose
11130606|NCT01756209|EG001|Reported Event|Ibuprofen|Ibuprofen 10 mg/kg oral single dose
11130607|NCT01756209|EG002|Reported Event|Mg + Acetaminophen|Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose
11130608|NCT01756209|EG003|Reported Event|Mg + Ibuprofen|Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
11130609|NCT01756235|BG000|Baseline|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
11130610|NCT01756235|FG000|Participant Flow|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice
11130611|NCT01756235|OG000|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
11130612|NCT01756235|EG000|Reported Event|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
11130613|NCT01756274|BG000|Baseline|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples. Baseline Characteristics for Participant Flow based on number of blood samples, not number of subjects.
11130614|NCT01756274|FG000|Participant Flow|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS.
11130615|NCT01756274|OG000|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
11130616|NCT01756274|OG000|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
11130617|NCT01756274|EG000|Reported Event|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory.
11130618|NCT01756300|BG000|Baseline|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
11130619|NCT01756300|FG000|Participant Flow|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension.
11130620|NCT01756300|OG000|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
11130621|NCT01756300|OG000|Outcome|Blood Pressures at Baseline|Office blood pressures measured at Baseline
11130622|NCT01756300|OG001|Outcome|Blood Pressures at 1-Month Follow Up|Office blood pressures measured at one month post-procedure
11130623|NCT01756300|OG002|Outcome|Blood Pressures at 3-Month Follow Up|Office blood pressures measured at 3-month post procedure
11130624|NCT01756300|OG003|Outcome|Blood Pressures at 6-Month Follow Up|Office blood pressures measured at 6-month post procedure
11130625|NCT01756300|OG004|Outcome|Blood Pressures at 12-Month Follow Up|Office blood pressures measured at 12-month post procedure
11130626|NCT01756300|OG000|Outcome|Blood Pressures at Baseline|ABPM blood pressures measured at Baseline
11130627|NCT01756300|OG001|Outcome|Blood Pressures at 3-Month Follow Up|ABPM blood pressures measured at 3-month post procedure
11130628|NCT01756300|OG002|Outcome|Blood Pressures at 6-Month Follow Up|ABPM blood pressures measured at 6-month post procedure
11130629|NCT01756300|OG003|Outcome|Blood Pressures at 12-Month Follow Up|ABPM blood pressures measured at 12-month post procedure
11130630|NCT01756300|OG000|Outcome|At One Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at one month post-procedure
11130631|NCT01756300|OG001|Outcome|At Three Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at three month post-procedure
11130632|NCT01756300|OG002|Outcome|At Six Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at six month post-procedure
11130633|NCT01756300|OG003|Outcome|At Twelve Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at twelve month post-procedure
11130634|NCT01756300|OG000|Outcome|At One Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at one month post-procedure
11130635|NCT01756300|OG001|Outcome|At Three Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at three month post-procedure
11130636|NCT01756300|OG002|Outcome|At Six Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at six month post-procedure
11130637|NCT01756300|OG003|Outcome|AT Twelve Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at Twelve month post-procedure
11130638|NCT01756300|EG000|Reported Event|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
11130639|NCT01756352|BG000|Baseline|GBM Avastin Receiving 18F-FET|"Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin~18F-FET: Radiotracer, surrogate marker for protein synthesis"
11130640|NCT01756352|FG000|Participant Flow|GBM Avastin Receiving 18F-FET|"Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin~18F-FET: Radiotracer, surrogate marker for protein synthesis"
11130641|NCT01756352|OG000|Outcome|GBM Avastin Receiving 18F-FET|"Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin~18F-FET: Radiotracer, surrogate marker for protein synthesis"
11130642|NCT01756352|EG000|Reported Event|GBM Avastin Receiving 18F-FET|"Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin~18F-FET: Radiotracer, surrogate marker for protein synthesis"
11130643|NCT01756391|BG000|Baseline|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
11130644|NCT01756391|FG000|Participant Flow|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
11130645|NCT01756391|OG000|Outcome|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
11130646|NCT01756391|EG000|Reported Event|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
11130647|NCT01756456|BG000|Baseline|1_rhNGF10_Phase 1_treatment|rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130648|NCT01756456|BG001|Baseline|2_rhNGF20_Phase 1_treatment|rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130649|NCT01756456|BG002|Baseline|3_vehicle group_Phase 1_treatment|Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130650|NCT01756456|BG003|Baseline|4_rhNGF10_Phase 2_treatment|rhNGF 10 µg/ml eye drops solution: rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130651|NCT01756456|BG004|Baseline|5_rhNGF20_Phase 2_treatment|rhNGF 20 µg/ml eye drops solution: rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130652|NCT01756456|BG005|Baseline|6_vehicle group_Phase 2_treatment|Placebo: Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only.
11130653|NCT01756456|BG006|Baseline|Total|Total of all reporting groups
11130654|NCT01756456|FG000|Participant Flow|1_rhNGF 10µg/ml Phase 1_treatment|rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130655|NCT01756456|FG001|Participant Flow|2_rhNGF 20 µg/ml_Phase 1_treatment|rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
10879644|NCT00459108|EG000|Reported Event|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
11130656|NCT01756456|FG002|Participant Flow|3_vehicle group_Phase 1_treatment|Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130657|NCT01756456|FG003|Participant Flow|4_rhNGF10_Phase 2_treatment|active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
11130658|NCT01756456|FG004|Participant Flow|5_rhNGF20_Phase 2_treatment|active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
11130659|NCT01756456|FG005|Participant Flow|6_vehicle group_Phase 2_treatment|vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
11130660|NCT01756456|OG000|Outcome|4_rhNGF10_Phase 2_treatment|active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
11130661|NCT01756456|OG001|Outcome|5_rhNGF20_Phase 2_treatment|active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
11130662|NCT01756456|OG002|Outcome|6_vehicle group_Phase 2_treatment|vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
11130663|NCT01756456|OG000|Outcome|1_rhNGF10_Phase 1_treatment|"active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35μg of rhNGF).~rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)"
11130664|NCT01756456|OG001|Outcome|2_rhNGF20_Phase 1_treatment|"active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)~rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)"
11130665|NCT01756456|OG002|Outcome|3_vehicle group_Phase 1_treatment|"vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period~vehicle: ophthalmic solution of the same composition as the test product without rhNGF"
11130666|NCT01756456|OG003|Outcome|4_rhNGF10_Phase 2_treatment|"active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)~rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)"
11130667|NCT01756456|OG004|Outcome|5_rhNGF20_Phase 2_treatment|"active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)~rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)"
10879645|NCT00459134|BG000|Baseline|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
11130668|NCT01756456|OG005|Outcome|6_vehicle group_Phase 2_treatment|"vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period~vehicle: ophthalmic solution of the same composition as the test product without rhNGF"
11130669|NCT01756456|OG006|Outcome|1_rhNGF10_Phase 1_FU|Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
11130670|NCT01756456|OG007|Outcome|2_rhNGF20_Phase 1_FU|Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
11130671|NCT01756456|OG008|Outcome|3_vehicle group_Phase 1_FU|Follow up for Phase 1 vehicle control arm
11130672|NCT01756456|OG009|Outcome|4_rhNGF10_Phase 2_FU|Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
11130673|NCT01756456|OG010|Outcome|5_rhNGF20_Phase 2_FU|Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
11130674|NCT01756456|OG011|Outcome|6_vehicle_Phase 2_FU|Follow up for Phase 2 vehicle control arm
11130675|NCT01756456|EG000|Reported Event|1_rhNGF10_Phase 1|rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130676|NCT01756456|EG001|Reported Event|2_rhNGF20_Phase 1|rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130677|NCT01756456|EG002|Reported Event|3_vehicle group_Phase 1|Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130678|NCT01756456|EG003|Reported Event|4_rhNGF10_Phase 2_treatment|rhNGF 10 µg/ml eye drops solution: rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130679|NCT01756456|EG004|Reported Event|5_rhNGF20_Phase 2_treatment|rhNGF 20 µg/ml eye drops solution: rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
11130680|NCT01756456|EG005|Reported Event|6_vehicle group_Phase 2_treatment|Placebo: Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only.
11130681|NCT01756833|BG000|Baseline|Doxycycline|"100 mg capsules, twice a day, for a period of two years.~Doxycycline: 100 mg po bid"
11130682|NCT01756833|BG001|Baseline|Placebo|"100 mg capsules, twice a day, for a period of two years.~Placebo: capsule identical to the doxycycline capsule"
11130683|NCT01756833|BG002|Baseline|Total|Total of all reporting groups
11130684|NCT01756833|FG000|Participant Flow|Doxycycline|"100 mg capsules, twice a day, for a period of two years.~Doxycycline: 100 mg po bid"
11130685|NCT01756833|FG001|Participant Flow|Placebo|"100 mg capsules, twice a day, for a period of two years.~Placebo: capsule identical to the doxycycline capsule"
11130686|NCT01756833|OG000|Outcome|Doxycycline|"100 mg capsules, twice a day, for a period of two years.~Doxycycline: 100 mg po bid"
11130687|NCT01756833|OG001|Outcome|Placebo|"100 mg capsules, twice a day, for a period of two years.~Placebo: capsule identical to the doxycycline capsule"
11130688|NCT01756833|EG000|Reported Event|Doxycycline|"100 mg capsules, twice a day, for a period of two years.~Doxycycline: 100 mg po bid"
11130689|NCT01756833|EG001|Reported Event|Placebo|"100 mg capsules, twice a day, for a period of two years.~Placebo: capsule identical to the doxycycline capsule"
11130690|NCT01756846|BG000|Baseline|Usual Care|standard care of the cardiologist according to current cardiological guidelines
10879646|NCT00459134|BG001|Baseline|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
11130691|NCT01756846|BG001|Baseline|HEART Care|standard care of the cardiologist according to current cardiological guidelines, complemented by calculation of the HEART score and following the recommended policy
11130692|NCT01756846|BG002|Baseline|Total|Total of all reporting groups
11130693|NCT01756846|FG000|Participant Flow|Usual Care|usual care was defined as daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).
11130694|NCT01756846|FG001|Participant Flow|HEART Care|"HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.~During 14 months, patients presenting with chest pain to the emergency department (ED) of participating hospitals were included in the study. First, all hospitals applied 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines."
11130695|NCT01756846|OG000|Outcome|Usual Care|usual care was defined as daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).
10879647|NCT00459134|BG002|Baseline|Total|Total of all reporting groups
11130696|NCT01756846|OG001|Outcome|HEART Care|HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.
11130697|NCT01756846|EG000|Reported Event|Usual Care|usual care was defined as daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).
11226848|NCT02378506|BG000|Baseline|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
11226849|NCT02378506|FG000|Participant Flow|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
11226850|NCT02378506|OG000|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
11130698|NCT01756846|EG001|Reported Event|HEART Care|"HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.~During 14 months, patients presenting with chest pain to the ED of participating hospitals were included in the study. First, all hospitals applied 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines."
11130699|NCT01756885|BG000|Baseline|Standard Varenicline Treatment|"12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Days 85-168: Placebo - 1.0mg twice daily orally~Varenicline~Placebo~Smoking Cessation Counseling"
11130700|NCT01756885|BG001|Baseline|Extended Varenicline Treatment|"24 weeks of active varenicline + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-168: 1.0mg twice daily orally~Varenicline~Smoking Cessation Counseling"
11130701|NCT01756885|BG002|Baseline|Total|Total of all reporting groups
11130702|NCT01756885|FG000|Participant Flow|Standard Varenicline Treatment|"12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Days 85-168: Placebo - 1.0mg twice daily orally~Varenicline~Placebo~Smoking Cessation Counseling"
11130703|NCT01756885|FG001|Participant Flow|Extended Varenicline Treatment|"24 weeks of active varenicline + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-168: 1.0mg twice daily orally~Varenicline~Smoking Cessation Counseling"
11130704|NCT01756885|OG000|Outcome|Standard Varenicline Treatment|"12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Days 85-168: Placebo - 1.0mg twice daily orally~Varenicline~Placebo~Smoking Cessation Counseling"
11130705|NCT01756885|OG001|Outcome|Extended Varenicline Treatment|"24 weeks of active varenicline + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-168: 1.0mg twice daily orally~Varenicline~Smoking Cessation Counseling"
11130706|NCT01756885|EG000|Reported Event|Standard Varenicline Treatment|"12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Days 85-168: Placebo - 1.0mg twice daily orally~Varenicline~Placebo~Smoking Cessation Counseling"
11130707|NCT01756885|EG001|Reported Event|Extended Varenicline Treatment|"24 weeks of active varenicline + smoking cessation counseling~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-168: 1.0mg twice daily orally~Varenicline~Smoking Cessation Counseling"
11130708|NCT01756898|BG000|Baseline|Placebo|Participants with atopic dermatitis were randomized to receive a placebo.
11130709|NCT01756898|BG001|Baseline|ASB17061 5 mg Low Dose|Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
11130710|NCT01756898|BG002|Baseline|ASB17061 10 mg Middle Dose|Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
11130711|NCT01756898|BG003|Baseline|ASB17061 20 mg High Dose|Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
11130712|NCT01756898|BG004|Baseline|Total|Total of all reporting groups
11130713|NCT01756898|FG000|Participant Flow|Placebo|Participants with atopic dermatitis were randomized to receive a placebo.
11130714|NCT01756898|FG001|Participant Flow|ASB17061 5 mg Low Dose|Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
11130715|NCT01756898|FG002|Participant Flow|ASB17061 10 mg Middle Dose|Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
11130716|NCT01756898|FG003|Participant Flow|ASB17061 20 mg High Dose|Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
11130717|NCT01756898|OG000|Outcome|Placebo|Participants with atopic dermatitis were randomized to receive a placebo.
11130718|NCT01756898|OG001|Outcome|ASB17061 5 mg Low Dose|Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
11130719|NCT01756898|OG002|Outcome|ASB17061 10 mg Middle Dose|Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
11130720|NCT01756898|OG003|Outcome|ASB17061 20 mg High Dose|Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
11130721|NCT01756898|OG000|Outcome|ASB17061 5 mg Low Dose|Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
11130722|NCT01756898|OG001|Outcome|ASB17061 10 mg Middle Dose|Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
10879648|NCT00459134|FG000|Participant Flow|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
11130723|NCT01756898|OG002|Outcome|ASB17061 20 mg High Dose|Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
11130724|NCT01756898|EG000|Reported Event|Placebo|Participants with atopic dermatitis were randomized to receive a placebo.
11130725|NCT01756898|EG001|Reported Event|ASB17061 5 mg Low Dose|Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
11130726|NCT01756898|EG002|Reported Event|ASB17061 10 mg Middle Dose|Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
11130727|NCT01756898|EG003|Reported Event|ASB17061 20 mg High Dose|Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
11130728|NCT01756976|BG000|Baseline|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
11130729|NCT01756976|BG001|Baseline|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
11130730|NCT01756976|BG002|Baseline|Total|Total of all reporting groups
11130731|NCT01756976|FG000|Participant Flow|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
11130732|NCT01756976|FG001|Participant Flow|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
11130733|NCT01756976|OG000|Outcome|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
11130734|NCT01756976|OG001|Outcome|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
11130735|NCT01756976|EG000|Reported Event|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
11130736|NCT01756976|EG001|Reported Event|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
11130737|NCT01757067|BG000|Baseline|Ablation Procedure|Patient received PVC ablation in addition to optimal medical therapy
11130738|NCT01757067|BG001|Baseline|Medical Therapy|Optimal medical therapy
11130739|NCT01757067|BG002|Baseline|Total|Total of all reporting groups
11130740|NCT01757067|FG000|Participant Flow|PVC Ablation Plus Optimal Medical Therapy|"Patients will receive optimal medical therapy including beta blocker or afterload reduction with e.g. ACE-inhibitors as directed by treating local cardiologist/electrophysiologist.~In addition patient will undergo radiofrequency ablation of PVC guided by current gold standard of ablation including pace mapping and activation mapping to reduce the PVC burden."
11130741|NCT01757067|FG001|Participant Flow|Optimal Medical Therapy|Patients will receive optimal medical therapy including beta blocker or afterload reduction with e.g. ACE-inhibitors as directed by treating local cardiologist/electrophysiologist.
11130742|NCT01757067|OG000|Outcome|Ablation Procedure|PVC ablation will be performed in these patients in addition to optimal medical therapy.
11130743|NCT01757067|OG001|Outcome|Optimal Medical Therapy|group received only optimal medical therapy
11130744|NCT01757067|EG000|Reported Event|Ablation Procedure and Optimal Medical Therapy|In the group that received PVC ablation and optimal medical therapy no AE occured.
11130745|NCT01757067|EG001|Reported Event|Optimal Medical Therapy|In the group that received optimal medical therapy no AE occured
11130746|NCT01757171|BG000|Baseline|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
11130747|NCT01757171|BG001|Baseline|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
11130748|NCT01757171|BG002|Baseline|Total|Total of all reporting groups
11130749|NCT01757171|FG000|Participant Flow|Arm A (Taxane naïve)|Arm A - No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks
11130750|NCT01757171|FG001|Participant Flow|Arm B (Prior Taxane Therapy)|Arm B - Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks
11130751|NCT01757171|OG000|Outcome|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
11130752|NCT01757171|OG001|Outcome|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
11130753|NCT01757171|EG000|Reported Event|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
11130754|NCT01757171|EG001|Reported Event|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
11130755|NCT01757184|BG000|Baseline|Double-Blind Sebelipase Alfa|Double-blind Period: IV infusions of sebelipase alfa at a dose of 1 mg/kg administered qow.
11130756|NCT01757184|BG001|Baseline|Double-Blind Placebo|Double-blind Period: IV infusions of placebo administered qow.
11130757|NCT01757184|BG002|Baseline|Total|Total of all reporting groups
11130758|NCT01757184|FG000|Participant Flow|Double-blind Sebelipase Alfa|Double-blind Period: Intravenous (IV) infusions of sebelipase alfa at a dose of 1 milligram/kilogram (mg/kg) administered every other week (qow).
11130759|NCT01757184|FG001|Participant Flow|Double-blind Placebo|Double-blind Period: IV infusions of placebo administered qow.
11130760|NCT01757184|FG002|Participant Flow|Open-label Sebelipase Alfa/Sebelipase Alfa|Participants who were randomized to receive sebelipase alfa during the Double-blind Period and also received sebelipase alfa in the Open-label Period. All participants received sebelipase alfa at a dose of 1 mg/kg qow, irrespective of treatment received in the Double-blind Period.
11130761|NCT01757184|FG003|Participant Flow|Open-label Placebo/Sebelipase Alfa|Participants who were randomized to receive placebo during the Double-blind Period and received sebelipase alfa in the Open-label Period. All participants received sebelipase alfa at a dose of 1 mg/kg qow, irrespective of treatment received in the Double-blind Period.
11130762|NCT01757184|OG000|Outcome|Double-blind Sebelipase Alfa|Double-blind Period: IV infusions of sebelipase alfa at a dose of 1 mg/kg administered qow.
11130763|NCT01757184|OG001|Outcome|Double-blind Placebo|Double-blind Period: IV infusions of placebo administered qow.
11130764|NCT01757184|OG002|Outcome|Open-label Sebelipase Alfa/Sebelipase Alfa|Participants who were randomized to receive sebelipase alfa during the Double-blind Period and also received sebelipase alfa in the Open-label Period. All participants received sebelipase alfa at a dose of 1 mg/kg qow, irrespective of treatment received in the Double-blind Period.
11130765|NCT01757184|OG003|Outcome|Open-label Placebo/Sebelipase Alfa|Participants who were randomized to receive placebo during the Double-blind Period and received sebelipase alfa in the Open-label Period. All participants received sebelipase alfa at a dose of 1 mg/kg qow, irrespective of treatment received in the Double-blind Period.
11130766|NCT01757184|OG000|Outcome|Double-Blind Sebelipase Alfa|Double-blind Period: IV infusions of sebelipase alfa at a dose of 1 mg/kg administered qow.
10879649|NCT00459134|FG001|Participant Flow|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
11130767|NCT01757184|OG001|Outcome|Double-Blind Placebo|Double-blind Period: IV infusions of placebo administered qow.
11130768|NCT01757184|OG002|Outcome|Open-Label Sebelipase Alfa/Sebelipase Alfa|Participants who were randomized to receive sebelipase alfa during the Double-blind Period and also received sebelipase alfa in the Open-label Period. All participants received sebelipase alfa at a dose of 1 mg/kg qow, irrespective of treatment received in the Double-blind Period.
11130769|NCT01757184|OG003|Outcome|Open-Label Placebo/Sebelipase Alfa|Participants who were randomized to receive placebo during the Double-blind Period and received sebelipase alfa in the Open-label Period. All participants received sebelipase alfa at a dose of 1 mg/kg qow, irrespective of treatment received in the Double-blind Period.
11130770|NCT01757184|EG000|Reported Event|Double-blind Sebelipase Alfa|Double-blind Period: IV infusions of sebelipase alfa at a dose of 1 mg/kg administered qow.
11130771|NCT01757184|EG001|Reported Event|Double-blind Placebo|Double-blind Period: IV infusions of placebo administered qow.
11130772|NCT01757184|EG002|Reported Event|Open-label Sebelipase Alfa/Sebelipase Alfa|Participants who were randomized to receive sebelipase alfa during the Double-blind Period and also received sebelipase alfa in the Open-label Period. All participants received sebelipase alfa at a dose of 1 mg/kg qow, irrespective of treatment received in the Double-blind Period.
11130773|NCT01757184|EG003|Reported Event|Open-label Placebo/Sebelipase Alfa|Participants who were randomized to receive placebo during the Double-blind Period and received sebelipase alfa in the Open-label Period. All participants received sebelipase alfa at a dose of 1 mg/kg qow, irrespective of treatment received in the Double-blind Period.
11130774|NCT01757197|BG000|Baseline|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
11130775|NCT01757197|FG000|Participant Flow|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
11130776|NCT01757197|OG000|Outcome|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
11130777|NCT01757197|EG000|Reported Event|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
11130778|NCT01757275|BG000|Baseline|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
11130779|NCT01757275|BG001|Baseline|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
11130780|NCT01757275|BG002|Baseline|Total|Total of all reporting groups
11130781|NCT01757275|FG000|Participant Flow|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
11130782|NCT01757275|FG001|Participant Flow|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
11130783|NCT01757275|OG000|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
11130784|NCT01757275|OG001|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
11130785|NCT01757275|EG000|Reported Event|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
11130786|NCT01757275|EG001|Reported Event|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
11130787|NCT01757288|BG000|Baseline|NAB-PACLITAXEL (Phase I)|"NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks~NAB-PACLITAXEL: nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks"
11130788|NCT01757288|BG001|Baseline|PACLITAXEL (Phase II, Arm A)|PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
11130789|NCT01757288|BG002|Baseline|NAB-PACLITAXEL (Phase II, Arm B)|NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
11130790|NCT01757288|BG003|Baseline|Total|Total of all reporting groups
11130791|NCT01757288|FG000|Participant Flow|NAB-PACLITAXEL (Phase I)|"NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks~Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy"
11130792|NCT01757288|FG001|Participant Flow|PACLITAXEL (Phase II, Arm A)|PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
11130793|NCT01757288|FG002|Participant Flow|NAB-PACLITAXEL (Phase II, Arm B)|NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
11130794|NCT01757288|OG000|Outcome|NAB-PACLITAXEL (Phase I)|"NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks~NAB-PACLITAXEL: nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks"
11130795|NCT01757288|OG001|Outcome|PACLITAXEL (Phase II, Arm A)|PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
11130796|NCT01757288|OG002|Outcome|NAB-PACLITAXEL (Phase II, Arm B)|NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
11130797|NCT01757288|OG000|Outcome|NAB-PACLITAXEL (Phase I)|"NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks~Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy"
11130798|NCT01757288|EG000|Reported Event|NAB-PACLITAXEL (Phase I)|"NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks~Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy"
11130799|NCT01757288|EG001|Reported Event|PACLITAXEL (Phase II, Arm A)|PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
11130800|NCT01757288|EG002|Reported Event|NAB-PACLITAXEL (Phase II, Arm B)|NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
11130801|NCT01757301|BG000|Baseline|Assisted Symptom Management (ASM)|"There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.~Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules."
11130802|NCT01757301|BG001|Baseline|Comprehensive Symptom Management (CSM)|"This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only).~Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only)."
11130803|NCT01757301|BG002|Baseline|Total|Total of all reporting groups
11130804|NCT01757301|FG000|Participant Flow|Assisted Symptom Management (ASM)|"There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.~Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules."
11130805|NCT01757301|FG001|Participant Flow|Comprehensive Symptom Management (CSM)|"This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only).~Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only)."
11130806|NCT01757301|OG000|Outcome|Assisted Symptom Management (ASM)|There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
11130807|NCT01757301|OG001|Outcome|Comprehensive Symptom Management (CSM)|"This arm couples ASM with care management by a nurse physician team, thus testing combined therapy vs.~monotherapy (ASM only). Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse physician team, thus testing combined therapy vs. monotherapy (ASM only)."
11130808|NCT01757301|OG000|Outcome|Assisted Symptom Management (ASM)|"There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.~Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules."
11130809|NCT01757301|OG001|Outcome|Comprehensive Symptom Management (CSM)|"This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only).~Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only)."
11130810|NCT01757301|EG000|Reported Event|Assisted Symptom Management (ASM)|"There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.~Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules."
11130811|NCT01757301|EG001|Reported Event|Comprehensive Symptom Management (CSM)|"This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only).~Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only)."
11130812|NCT01757392|BG000|Baseline|Candin® 0.3 mL|Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesion resolves or up to 6 injections.
11130813|NCT01757392|FG000|Participant Flow|Candin® 0.3 mL|Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
11130814|NCT01757392|OG000|Outcome|Candin® 0.3 mL|Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
11130815|NCT01757392|EG000|Reported Event|Candin® 0.3 mL|Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml until lesion resolves or up to 6 injections.
11130816|NCT01757405|BG000|Baseline|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
11130817|NCT01757405|BG001|Baseline|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
11130818|NCT01757405|BG002|Baseline|Total|Total of all reporting groups
11130819|NCT01757405|FG000|Participant Flow|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
11130820|NCT01757405|FG001|Participant Flow|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
11130821|NCT01757405|OG000|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
11130822|NCT01757405|OG001|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
11130823|NCT01757405|EG000|Reported Event|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions.
11130824|NCT01757405|EG001|Reported Event|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
11130825|NCT01757561|BG000|Baseline|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
11130826|NCT01757561|BG001|Baseline|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
11130827|NCT01757561|BG002|Baseline|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
11130828|NCT01757561|BG003|Baseline|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
11130829|NCT01757561|BG004|Baseline|Total|Total of all reporting groups
11130830|NCT01757561|FG000|Participant Flow|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
11130831|NCT01757561|FG001|Participant Flow|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
11130832|NCT01757561|FG002|Participant Flow|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
11130833|NCT01757561|FG003|Participant Flow|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
11130834|NCT01757561|OG000|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
11130835|NCT01757561|OG001|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
11130836|NCT01757561|OG002|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
11130837|NCT01757561|OG003|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
11130838|NCT01757561|EG000|Reported Event|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
11130839|NCT01757561|EG001|Reported Event|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
11130840|NCT01757561|EG002|Reported Event|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
11130841|NCT01757561|EG003|Reported Event|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
11130842|NCT01757678|BG000|Baseline|Standard of Care: FFR and ICA|"Single arm~Measured FFR (Fractional Flow Reserve) and ICA (Invasive Coronary Angiography)"
11130843|NCT01757678|FG000|Participant Flow|Standard of Care: FFR and ICA|"Single arm~Measured FFR: Fractional Flow Reserve"
11130844|NCT01757678|OG000|Outcome|FFRct vs. FFR|
11130845|NCT01757678|OG001|Outcome|cCTA vs. FFR|
11130846|NCT01757678|OG000|Outcome|Standard of Care: FFR and ICA|(ICA) Invasive coronary angiography with (FFR) fractional flow reserve measurement in standard of care environment.
11130847|NCT01757678|EG000|Reported Event|Standard of Care: ICA (Invasive Coronary Angiography)|(ICA) Invasive coronary angiography in standard of care environment.
11130848|NCT01757678|EG001|Reported Event|Standard of Care: cCTA (Coronary Computed Tomography Angio)|(cCTA) Coronary computed tomography angiography in standard of care environment.
11130849|NCT01757678|EG002|Reported Event|Standard of Care: FFR (Fractional Flow Reserve)|(FFR) Fractional flow reserve in standard of care environment.
11130850|NCT01757691|BG000|Baseline|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
11130851|NCT01757691|FG000|Participant Flow|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
11130852|NCT01757691|FG001|Participant Flow|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
11130853|NCT01757691|OG000|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
11130854|NCT01757691|OG001|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
11130855|NCT01757691|EG000|Reported Event|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
11130856|NCT01757691|EG001|Reported Event|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
11149565|NCT01871506|EG000|Reported Event|Standard Treatment (ST)|"Participants randomized to standard treatment (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.~Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.~(2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.~(3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects."
11149566|NCT01871506|EG001|Reported Event|Intensive Treatment (IT)|"Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive:~Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).~Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication [varenicline, bupropion, or combination NRT (patch + lozenge)] at no cost to the participant.~I"
11226851|NCT02378506|EG000|Reported Event|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
11130857|NCT01757704|BG000|Baseline|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
11130858|NCT01757704|BG001|Baseline|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
11130859|NCT01757704|BG002|Baseline|Total|Total of all reporting groups
11130860|NCT01757704|FG000|Participant Flow|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
11130861|NCT01757704|FG001|Participant Flow|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
11130862|NCT01757704|OG000|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
11130863|NCT01757704|OG001|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
11130864|NCT01757704|EG000|Reported Event|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
10879650|NCT00459134|OG000|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
11130865|NCT01757704|EG001|Reported Event|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
11130866|NCT01757717|BG000|Baseline|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
11130867|NCT01757717|FG000|Participant Flow|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
11130868|NCT01757717|OG000|Outcome|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
11130869|NCT01757717|EG000|Reported Event|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
11130870|NCT01757821|BG000|Baseline|Real 6-Hz Priming Sham 6-Hz Priming Real 1-Hz rTMS Only|"real 6-Hz primed low-frequency rTMS~real 6-Hz primed low-frequency rTMS:~Sham 6-Hz Primed low-frequency rTMS~real 1-Hz rTMS only"
11130871|NCT01757821|FG000|Participant Flow|6-Hz Priming|"real 6-Hz primed low-frequency rTMS~real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region~Sham 6-Hz Primed low-frequency rTMS~real 1-Hz rTMS only~real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region~Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
11130872|NCT01757821|OG000|Outcome|Real 6-Hz Priming|"real 6-Hz primed low-frequency rTMS~real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
11130873|NCT01757821|OG001|Outcome|Sham 6-Hz Priming|"Sham 6-Hz Primed low-frequency rTMS~Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
11130874|NCT01757821|OG002|Outcome|Real 1-Hz rTMS Only|"real 1-Hz rTMS only~real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region"
11130875|NCT01757821|EG000|Reported Event|Real 6-Hz Priming|"real 6-Hz primed low-frequency rTMS~real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
11130876|NCT01757821|EG001|Reported Event|Sham 6-Hz Priming|"Sham 6-Hz Primed low-frequency rTMS~Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
11130877|NCT01757821|EG002|Reported Event|Real 1-Hz rTMS Only|"real 1-Hz rTMS only~real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region"
11149567|NCT01871519|BG000|Baseline|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
11226852|NCT02378662|BG000|Baseline|Group A|18-25 IU/Kg/day
11226853|NCT02378662|BG001|Baseline|Group B|35-45 IU/Kg/day
11130878|NCT01757847|BG000|Baseline|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy
11130879|NCT01757847|BG001|Baseline|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
11130880|NCT01757847|BG002|Baseline|Total|Total of all reporting groups
11130881|NCT01757847|FG000|Participant Flow|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
11130882|NCT01757847|FG001|Participant Flow|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
11130883|NCT01757847|OG000|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
11130884|NCT01757847|OG001|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
11130885|NCT01757847|EG000|Reported Event|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
11130886|NCT01757847|EG001|Reported Event|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
11130887|NCT01757964|BG000|Baseline|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
11130888|NCT01757964|BG001|Baseline|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
11130889|NCT01757964|BG002|Baseline|Total|Total of all reporting groups
11130890|NCT01757964|FG000|Participant Flow|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
11130891|NCT01757964|FG001|Participant Flow|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
11130892|NCT01757964|OG000|Outcome|Bacteriotherapy|"Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.~Bacteriotherapy"
11130893|NCT01757964|EG000|Reported Event|Bacteriotherapy|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
11130894|NCT01758289|BG000|Baseline|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
11130895|NCT01758289|FG000|Participant Flow|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
11130896|NCT01758289|OG000|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
11130897|NCT01758289|OG000|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
11130898|NCT01758289|OG001|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
11130899|NCT01758289|OG002|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
11130900|NCT01758289|OG001|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
11130901|NCT01758289|EG000|Reported Event|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
11130902|NCT01758432|BG000|Baseline|Module 1 Placebo|Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
11130903|NCT01758432|BG001|Baseline|Module 1 ( 90 mg)|90 mg andexanet IV bolus administered over 3 minutes (~30 mg/min)
11130904|NCT01758432|BG002|Baseline|Module 1 (210 mg)|210 mg andexanet IV bolus administered over 10 minutes (~30 mg/min)
11130905|NCT01758432|BG003|Baseline|Module 1 (420 mg)|420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min)
11130906|NCT01758432|BG004|Baseline|Module 1 (420 mg Bolus + 180 mg Infusion)|420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg]
11130907|NCT01758432|BG005|Baseline|Module 1 (420 mg Bolus + 180 mg Bolus)|420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg]
11130908|NCT01758432|BG006|Baseline|Module 1 (420 mg Bolus + 480 mg Infusion)|420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg]
11130909|NCT01758432|BG007|Baseline|Total|Total of all reporting groups
11130910|NCT01758432|FG000|Participant Flow|Module 1 Placebo|Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
11130911|NCT01758432|FG001|Participant Flow|Module 1 ( 90 mg)|90 mg andexanet IV bolus administered over 3 minutes (~30 mg/min)
11130912|NCT01758432|FG002|Participant Flow|Module 1 (210 mg)|210 mg andexanet IV bolus administered over 10 minutes (~30 mg/min)
10879651|NCT00459134|OG001|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
11130913|NCT01758432|FG003|Participant Flow|Module 1 (420 mg)|420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min)
11130914|NCT01758432|FG004|Participant Flow|Module 1 (420 mg Bolus + 180 mg Infusion)|420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg]
11130915|NCT01758432|FG005|Participant Flow|Module 1 (420 mg Bolus + 180 mg Bolus)|420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg]
11130916|NCT01758432|FG006|Participant Flow|Module 1 (420 mg Bolus + 480 mg Infusion)|420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg]
11130917|NCT01758432|OG000|Outcome|Module 1 Placebo|Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
11130918|NCT01758432|OG001|Outcome|Module 1 ( 90 mg)|90 mg andexanet IV bolus administered over 3 minutes (~30 mg/min)
11130919|NCT01758432|OG002|Outcome|Module 1 (210 mg)|210 mg andexanet IV bolus administered over 10 minutes (~30 mg/min)
11130920|NCT01758432|OG003|Outcome|Module 1 (420 mg)|420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min)
11130921|NCT01758432|OG004|Outcome|Module 1 (420 mg Bolus + 180 mg Infusion)|420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg]
11130922|NCT01758432|OG005|Outcome|Module 1 (420 mg Bolus + 180 mg Bolus)|420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg]
11130923|NCT01758432|OG006|Outcome|Module 1 (420 mg Bolus + 480 mg Infusion)|420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg]
11130924|NCT01758432|EG000|Reported Event|Module 1 Placebo|Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
11130925|NCT01758432|EG001|Reported Event|Module 1 ( 90 mg)|90 mg andexanet IV bolus administered over 3 minutes (~30 mg/min)
11130926|NCT01758432|EG002|Reported Event|Module 1 (210 mg)|210 mg andexanet IV bolus administered over 10 minutes (~30 mg/min) 420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min)
11130927|NCT01758432|EG003|Reported Event|Module 1 (420 mg)|420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min)
11130928|NCT01758432|EG004|Reported Event|Module 1 (420 mg Bolus + 180 mg Infusion)|420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg]
11130929|NCT01758432|EG005|Reported Event|Module 1 (420 mg Bolus + 180 mg Bolus)|420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg]
11130930|NCT01758432|EG006|Reported Event|Module 1 (420 mg Bolus + 480 mg Infusion)|420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg]
11130931|NCT01758523|BG000|Baseline|Dutasteride|"4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.~Dutasteride"
11130932|NCT01758523|BG001|Baseline|Sugar Pill|"Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.~sugar pill"
11130933|NCT01758523|BG002|Baseline|Total|Total of all reporting groups
11130934|NCT01758523|FG000|Participant Flow|Dutasteride|"4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.~Dutasteride"
11130935|NCT01758523|FG001|Participant Flow|Sugar Pill|"Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.~sugar pill"
11130936|NCT01758523|OG000|Outcome|Dutasteride|"4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.~Dutasteride"
11130937|NCT01758523|OG001|Outcome|Sugar Pill|"Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.~sugar pill"
11130938|NCT01758523|OG000|Outcome|Dutasteride - AKR1C3*2 CC|dutasteride treated AKR1C3*2 CC genotype subjects
11130939|NCT01758523|OG001|Outcome|Sugar Pill - AKR1C3*2 CC|placebo treated AKR1C3*2 CC genotype subjects
11130940|NCT01758523|OG002|Outcome|Dutasteride - AKR1C3*2 G-carrier|dutasteride treated AKR1C3*2 G-carrier genotype subjects
11130941|NCT01758523|OG003|Outcome|Sugar Pill - AKR1C3*2 G-carrier|placebo treated AKR1C3*2 G-carrier genotype subjects
11130942|NCT01758523|EG000|Reported Event|Dutasteride|"4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.~Dutasteride"
11130943|NCT01758523|EG001|Reported Event|Sugar Pill|"Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.~sugar pill"
11130944|NCT01758588|BG000|Baseline|Treatment Arm|Patients treated with 50mcg of peginterferon alfa-2b subcutaneously per week.
11130945|NCT01758588|BG001|Baseline|Observation Arm|Patients who did not receive treatment and were observed only.
11130946|NCT01758588|BG002|Baseline|Total|Total of all reporting groups
11130947|NCT01758588|FG000|Participant Flow|Treatment Arm|50mcg peginterferon alfa-2b subcutaneously per week
11130948|NCT01758588|FG001|Participant Flow|Observation Arm|Patients were observed and did not receive treatment.
11130949|NCT01758588|OG000|Outcome|Treatment Arm|Patients treated with 50mcg of peginterferon alfa-2b subcutaneously per week.
11130950|NCT01758588|OG001|Outcome|Observation Arm|Patients who did not receive treatment and were observed only.
11130951|NCT01758588|OG000|Outcome|Treatment Arm|Subjects treated with 50mcg of peginterferon alfa-2b subcutaneously per week.
11130952|NCT01758588|OG001|Outcome|Observation Arm|Patients were not treated and observed only.
11130953|NCT01758588|EG000|Reported Event|Treatment Arm|Patients treated with 50mcg of peginterferon alfa-2b subcutaneously per week.
11130954|NCT01758588|EG001|Reported Event|Observation Arm|Patients on the non-interventional arm.
11130955|NCT01758731|BG000|Baseline|Olaparib With C225 and Radiation Therapy|"Patients begin taking Olaparib at the assigned dose three days prior to their first Cetuximab infusion. Patients will receive an initial dose of Cetuximab, 400 mg/m², intravenously over 120 minutes on Day 1. The initial dose of C225 will precede the start of radiation by 5-7 days. All patients will receive RT to a total dose of 69.3 Gy in 33 fractions over 6½ weeks. Weekly C225 will be administered at 250 mg/m2 in combination with daily RT. Patients will be assigned to receive Olaparib (25, 50, 100 or 200 mg bid) in combination with RT and C225. Olaparib will be taken twice daily, beginning three days prior to first scheduled C225 infusion. A further dose level of 300mg or 400mg may be considered should the 200mg Olaparib dose be well tolerated in this C225/RT combination schedule.~Olaparib: Olaparib PO (25, 50, 100 or 200 mg bid) in combination with RT and C225. BID, beginning three days prior to first C225 infusion and discontinued after RT completed.~Cetuximab: Pre-RT cet"
11130956|NCT01758731|FG000|Participant Flow|Olaparib With C225 and Radiation Therapy|"Patients begin taking Olaparib at the assigned dose three days prior to their first Cetuximab infusion. Patients will receive an initial dose of Cetuximab, 400 mg/m², intravenously over 120 minutes on Day 1. The initial dose of C225 will precede the start of radiation by 5-7 days. All patients will receive RT to a total dose of 69.3 Gy in 33 fractions over 6½ weeks. Weekly C225 will be administered at 250 mg/m2 in combination with daily RT. Patients will be assigned to receive Olaparib (25, 50, 100 or 200 mg bid) in combination with RT and C225. Olaparib will be taken twice daily, beginning three days prior to first scheduled C225 infusion. A further dose level of 300mg or 400mg may be considered should the 200mg Olaparib dose be well tolerated in this C225/RT combination schedule.~Olaparib: Olaparib PO (25, 50, 100 or 200 mg bid) in combination with RT and C225. BID, beginning three days prior to first C225 infusion and discontinued after RT completed.~Cetuximab: Pre-RT cet"
11130957|NCT01758731|OG000|Outcome|Olaparib With C225 and Radiation Therapy|"Patients begin taking Olaparib at the assigned dose three days prior to their first Cetuximab infusion. Patients will receive an initial dose of Cetuximab, 400 mg/m², intravenously over 120 minutes on Day 1. The initial dose of C225 will precede the start of radiation by 5-7 days. All patients will receive RT to a total dose of 69.3 Gy in 33 fractions over 6½ weeks. Weekly C225 will be administered at 250 mg/m2 in combination with daily RT. Patients will be assigned to receive Olaparib (25, 50, 100 or 200 mg bid) in combination with RT and C225. Olaparib will be taken twice daily, beginning three days prior to first scheduled C225 infusion. A further dose level of 300mg or 400mg may be considered should the 200mg Olaparib dose be well tolerated in this C225/RT combination schedule.~Olaparib: Olaparib PO (25, 50, 100 or 200 mg bid) in combination with RT and C225. BID, beginning three days prior to first C225 infusion and discontinued after RT completed.~Cetuximab: Pre-RT cet"
11130958|NCT01758731|EG000|Reported Event|Olaparib With C225 and Radiation Therapy|"Patients begin taking Olaparib at the assigned dose three days prior to their first Cetuximab infusion. Patients will receive an initial dose of Cetuximab, 400 mg/m², intravenously over 120 minutes on Day 1. The initial dose of C225 will precede the start of radiation by 5-7 days. All patients will receive RT to a total dose of 69.3 Gy in 33 fractions over 6½ weeks. Weekly C225 will be administered at 250 mg/m2 in combination with daily RT. Patients will be assigned to receive Olaparib (25, 50, 100 or 200 mg bid) in combination with RT and C225. Olaparib will be taken twice daily, beginning three days prior to first scheduled C225 infusion. A further dose level of 300mg or 400mg may be considered should the 200mg Olaparib dose be well tolerated in this C225/RT combination schedule.~Olaparib: Olaparib PO (25, 50, 100 or 200 mg bid) in combination with RT and C225. BID, beginning three days prior to first C225 infusion and discontinued after RT completed.~Cetuximab: Pre-RT cet"
11130959|NCT01758900|BG000|Baseline|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
11130960|NCT01758900|BG001|Baseline|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
11130961|NCT01758900|BG002|Baseline|Total|Total of all reporting groups
11130962|NCT01758900|FG000|Participant Flow|CO2(Carbon Dioxide) Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE(single-balloon enteroscopy)."
11130963|NCT01758900|FG001|Participant Flow|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
11130964|NCT01758900|OG000|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
11130965|NCT01758900|OG001|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
11130966|NCT01758900|EG000|Reported Event|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
11130967|NCT01758900|EG001|Reported Event|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
11226854|NCT02378662|BG002|Baseline|Total|Total of all reporting groups
11130968|NCT01759160|BG000|Baseline|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
11130969|NCT01759160|BG001|Baseline|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
11130970|NCT01759160|BG002|Baseline|Total|Total of all reporting groups
11130971|NCT01759160|FG000|Participant Flow|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
11130972|NCT01759160|FG001|Participant Flow|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
11130973|NCT01759160|OG000|Outcome|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
11130974|NCT01759160|OG001|Outcome|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
11130975|NCT01759160|EG000|Reported Event|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
11130976|NCT01759160|EG001|Reported Event|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
11130977|NCT01759251|BG000|Baseline|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
11130978|NCT01759251|FG000|Participant Flow|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
11130979|NCT01759251|OG000|Outcome|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
11130980|NCT01759251|EG000|Reported Event|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
11130981|NCT01759264|BG000|Baseline|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
11130982|NCT01759264|FG000|Participant Flow|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
11130983|NCT01759264|OG000|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
11130984|NCT01759264|OG001|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
11130985|NCT01759264|EG000|Reported Event|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
10879652|NCT00459134|EG000|Reported Event|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
11130986|NCT01759277|BG000|Baseline|Control|"Femoral perineural local anesthetic infusion~Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic."
11130987|NCT01759277|BG001|Baseline|Experimental|"Adductor canal perineural local anesthetic infusion~Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic."
11130988|NCT01759277|BG002|Baseline|Total|Total of all reporting groups
11130989|NCT01759277|FG000|Participant Flow|Control|"Femoral perineural local anesthetic infusion~Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic."
11130990|NCT01759277|FG001|Participant Flow|Experimental|"Adductor canal perineural local anesthetic infusion~Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic."
11130991|NCT01759277|OG000|Outcome|Control|"Femoral perineural local anesthetic infusion~Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic."
11130992|NCT01759277|OG001|Outcome|Experimental|"Adductor canal perineural local anesthetic infusion~Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic."
11130993|NCT01759277|OG000|Outcome|Control|"Femoral perineural local anesthetic infusion~Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion"
11130994|NCT01759277|OG001|Outcome|Experimental|"Adductor canal perineural local anesthetic infusion~Experimental: Adductor Canal perineural local anesthetic infusion: The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion"
11130995|NCT01759277|EG000|Reported Event|Control|"Femoral perineural local anesthetic infusion~Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic."
11130996|NCT01759277|EG001|Reported Event|Experimental|"Adductor canal perineural local anesthetic infusion~Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic."
11130997|NCT01759290|BG000|Baseline|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
11130998|NCT01759290|FG000|Participant Flow|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
11130999|NCT01759290|OG000|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
11131000|NCT01759290|EG000|Reported Event|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
11131001|NCT01759368|BG000|Baseline|Telemonitoring-assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not mak
11131002|NCT01759368|BG001|Baseline|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity.
11131003|NCT01759368|BG002|Baseline|Total|Total of all reporting groups
11131004|NCT01759368|FG000|Participant Flow|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
11131005|NCT01759368|FG001|Participant Flow|Control Group|Control group received multidisciplinary care that was standard.
11131006|NCT01759368|OG000|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
11131007|NCT01759368|OG001|Outcome|Control Group|Control group received usual care
11131008|NCT01759368|OG000|Outcome|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
11131009|NCT01759368|OG001|Outcome|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity
11131010|NCT01759368|EG000|Reported Event|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
11131011|NCT01759368|EG001|Reported Event|Control Group|Control group received usual care
11131012|NCT01759381|BG000|Baseline|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
11131013|NCT01759381|BG001|Baseline|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
11131014|NCT01759381|BG002|Baseline|Total|Total of all reporting groups
11131015|NCT01759381|FG000|Participant Flow|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
11131016|NCT01759381|FG001|Participant Flow|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
11131017|NCT01759381|OG000|Outcome|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
11131018|NCT01759381|OG001|Outcome|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
11131019|NCT01759381|EG000|Reported Event|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
11131020|NCT01759381|EG001|Reported Event|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
11131021|NCT01759407|BG000|Baseline|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
11131022|NCT01759407|BG001|Baseline|Standard Anesthetic Management|
11131023|NCT01759407|BG002|Baseline|Total|Total of all reporting groups
11131024|NCT01759407|FG000|Participant Flow|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
11131025|NCT01759407|FG001|Participant Flow|Standard Anesthetic Management|
11131026|NCT01759407|OG000|Outcome|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
11131027|NCT01759407|OG001|Outcome|Standard Anesthetic Management|
11131028|NCT01759407|EG000|Reported Event|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
11131029|NCT01759407|EG001|Reported Event|Standard Anesthetic Management|
11131030|NCT01759420|BG000|Baseline|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
11131031|NCT01759420|FG000|Participant Flow|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
11131032|NCT01759420|OG000|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
11131033|NCT01759420|EG000|Reported Event|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
11226855|NCT02378662|FG000|Participant Flow|Group A|18-25 IU/Kg/day
10879653|NCT00459134|EG001|Reported Event|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
11131034|NCT01759446|BG000|Baseline|Placebo Taken First|followed by all other doses crossover
11131035|NCT01759446|BG001|Baseline|Generic H/A Taken First|followed by all other doses crossover
11131036|NCT01759446|BG002|Baseline|Vycavert Taken First|followed by all other doses crossover
11131037|NCT01759446|BG003|Baseline|Generic H/A Plus i Taken First|followed by all other doses crossover
11131038|NCT01759446|BG004|Baseline|Generic H/A Plus p Taken First|followed by all other doses crossover
11131039|NCT01759446|BG005|Baseline|Total|Total of all reporting groups
11131040|NCT01759446|FG000|Participant Flow|Placebo Taken First|followed by all other drugs with 48 hours washout in between
11131041|NCT01759446|FG001|Participant Flow|Generic H/A Taken First|followed by all other drugs with 48 hours washout in between
11131042|NCT01759446|FG002|Participant Flow|Vycavert Taken First|followed by all other drugs with 48 hours washout in between
11131043|NCT01759446|FG003|Participant Flow|Generic H/A Plus i Taken First|followed by all other drugs with 48 hours washout in between
11131044|NCT01759446|FG004|Participant Flow|Generic H/A Plus p Taken First|followed by all other drugs with 48 hours washout in between
11131045|NCT01759446|OG000|Outcome|Placebo|Placebo
11131046|NCT01759446|OG001|Outcome|Generic H/A|Hydrocodone and Acetaminophen
11131047|NCT01759446|OG002|Outcome|Vycavert|hydrocodone and acetaminophen
11131048|NCT01759446|OG003|Outcome|Generic H/A Plus i|Hydrocodone/Acetaminophen with selected inactives
11131049|NCT01759446|OG004|Outcome|Generic H/A Plus p|Hydrocodone/Acetaminophen plus placebo
11131050|NCT01759446|EG000|Reported Event|Placebo|Placebo
11131051|NCT01759446|EG001|Reported Event|Generic H/A|Hydrocodone and Acetaminophen
11131052|NCT01759446|EG002|Reported Event|Vycavert|hydrocodone and acetaminophen
11131053|NCT01759446|EG003|Reported Event|Generic H/A Plus i|Hydrocodone/Acetaminophen with selected inactives
11131054|NCT01759446|EG004|Reported Event|Generic H/A Plus p|Hydrocodone/Acetaminophen plus placebo
11131055|NCT01759511|BG000|Baseline|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
11131056|NCT01759511|FG000|Participant Flow|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
11131057|NCT01759511|OG000|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
11131058|NCT01759511|EG000|Reported Event|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
11131059|NCT01759602|BG000|Baseline|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
11131060|NCT01759602|FG000|Participant Flow|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
11131061|NCT01759602|OG000|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
11131062|NCT01759602|EG000|Reported Event|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
11131063|NCT01759862|BG000|Baseline|Aminophylline|"Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.~Theophylline drug levels will be monitored daily for 4 days.~Aminophylline: Aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.~Theophylline drug levels: Theophylline drug levels will be monitored every morning from all patients for the first 4 days post- transplant."
11131064|NCT01759862|BG001|Baseline|Control|"Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses.~Drug levels will be monitored daily for 4 days.~Theophylline drug levels: Theophylline drug levels will be monitored every morning from all patients for the first 4 days post- transplant.~Placebo: Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses."
11131065|NCT01759862|BG002|Baseline|Total|Total of all reporting groups
11131066|NCT01759862|FG000|Participant Flow|Aminophylline|"Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.~Theophylline drug levels will be monitored daily for 4 days. Target theophylline level is 5-7mcg/ml. Aminophylline dosing will be adjusted in order to achieve desired levels as stated in the study protocol."
11131067|NCT01759862|FG001|Participant Flow|Control|Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses. Drug levels will be monitored daily for 4 days.
11226856|NCT02378662|FG001|Participant Flow|Group B|35-45 IU/Kg/day
11226857|NCT02378662|OG000|Outcome|Group A|18-25 IU/Kg/day
11131068|NCT01759862|OG000|Outcome|Aminophylline|"Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.~Theophylline drug levels will be monitored daily for 4 days. Target theophylline level is 5-7mcg/ml. Aminophylline dosing will be adjusted in order to achieve desired levels as stated in the study protocol."
11131069|NCT01759862|OG001|Outcome|Control|Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses. Drug levels will be monitored daily for 4 days.
11131070|NCT01759862|EG000|Reported Event|Aminophylline|"Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.~Theophylline drug levels will be monitored daily for 4 days. Target theophylline level is 5-7mcg/ml. Aminophylline dosing will be adjusted in order to achieve desired levels as stated in the study protocol."
11131071|NCT01759862|EG001|Reported Event|Control|Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses. Drug levels will be monitored daily for 4 days.
11131072|NCT01760187|BG000|Baseline|Placebo - Japanese Patients|"8 Japanese patients will receive placebo, across the cohorts.~(2 at each cohort)"
11131073|NCT01760187|BG001|Baseline|Placebo - Caucasian Patients|"8 Caucasian patients will receive placebo, across the cohorts.~(2 at each cohort)"
11131074|NCT01760187|BG002|Baseline|Cohort 1- Japanese Patients|10 Japanese subjects will receive 10 mg of lomitapide.
11131075|NCT01760187|BG003|Baseline|Cohort 1 - Caucasian Patients|10 Caucasian subjects will receive 10 mg of lomitapide.
11131076|NCT01760187|BG004|Baseline|Cohort 2 - Japanese Patients|6 Japanese subjects will receive 20 mg of lomitapide.
11131077|NCT01760187|BG005|Baseline|Cohort 2 - Caucasian Patients|6 Caucasian subjects will receive 20 mg of lomitapide.
11131078|NCT01760187|BG006|Baseline|Cohort 3 - Japanese Patients|6 Japanese subjects will receive 40 mg of lomitapide.
11131079|NCT01760187|BG007|Baseline|Cohort 3 - Caucasian Patients|6 Caucasian subjects will receive 40 mg of lomitapide.
11131080|NCT01760187|BG008|Baseline|Cohort 4 - Japanese Patients|6 Japanese subjects will receive 60 mg of lomitapide.
11131081|NCT01760187|BG009|Baseline|Cohort 4 - Caucasian Patients|6 Caucasian subjects will receive 60 mg of lomitapide.
11131082|NCT01760187|BG010|Baseline|Total|Total of all reporting groups
11131083|NCT01760187|FG000|Participant Flow|Cohort 1|10 Japanese and 10 Caucasian subjects will receive 10 mg lomitapide.
11131084|NCT01760187|FG001|Participant Flow|Cohort 2|6 Japanese and 6 Caucasian subjects will receive 20 mg lomitapide.
11131085|NCT01760187|FG002|Participant Flow|Cohort 3|6 Japanese and 6 Caucasian subjects will receive 40 mg lomitapide.
11131086|NCT01760187|FG003|Participant Flow|Cohort 4|6 Japanese and 6 Caucasian subjects will receive 60 mg lomitapide.
11131087|NCT01760187|FG004|Participant Flow|Placebo|8 Japanese and 8 Caucasian subjects will receive placebo.
11131088|NCT01760187|OG000|Outcome|Japanese 10 mg|Japanese Subjects who received 10 mg Lomitapide
11131089|NCT01760187|OG001|Outcome|Caucasian 10 mg|Caucasian Subjects who received 10 mg Lomitapide
11131090|NCT01760187|OG002|Outcome|Japanese 20 mg|Japanese Subjects who received 20 mg Lomitapide
11131091|NCT01760187|OG003|Outcome|Caucasian 20 mg|Caucasian Subjects who received 20 mg Lomitapide
11131092|NCT01760187|OG004|Outcome|Japanese 40 mg|Japanese Subjects who received 40 mg Lomitapide
11131093|NCT01760187|OG005|Outcome|Caucasian 40 mg|Caucasian Subjects who received 40 mg Lomitapide
11131094|NCT01760187|OG006|Outcome|Japanese 60 mg|Japanese Subjects who received 60 mg Lomitapide
11131095|NCT01760187|OG007|Outcome|Caucasian 60 mg|Caucasian Subjects who received 60 mg Lomitapide
11131096|NCT01760187|EG000|Reported Event|Placebo - Japanese Patients|"8 Japanese patients will receive placebo, across the cohorts.~(2 at each cohort)"
11131097|NCT01760187|EG001|Reported Event|Placebo - Caucasian Patients|"8 Caucasian patients will receive placebo, across the cohorts.~(2 at each cohort)"
11131098|NCT01760187|EG002|Reported Event|Cohort 1- Japanese Patients|10 Japanese subjects will receive 10 mg of lomitapide.
11131099|NCT01760187|EG003|Reported Event|Cohort 1 - Caucasian Patients|10 Caucasian subjects will receive 10 mg of lomitapide.
11131100|NCT01760187|EG004|Reported Event|Cohort 2 - Japanese Patients|6 Japanese subjects will receive 20 mg of lomitapide.
11131101|NCT01760187|EG005|Reported Event|Cohort 2 - Caucasian Patients|6 Caucasian subjects will receive 20 mg of lomitapide.
11131102|NCT01760187|EG006|Reported Event|Cohort 3 - Japanese Patients|6 Japanese subjects will receive 40 mg of lomitapide.
11131103|NCT01760187|EG007|Reported Event|Cohort 3 - Caucasian Patients|6 Caucasian subjects will receive 40 mg of lomitapide.
11131104|NCT01760187|EG008|Reported Event|Cohort 4 - Japanese Patients|6 Japanese subjects will receive 60 mg of lomitapide.
11131105|NCT01760187|EG009|Reported Event|Cohort 4 - Caucasian Patients|6 Caucasian subjects will receive 60 mg of lomitapide.
11131106|NCT01760239|BG000|Baseline|Clincal Decision Support (CDS)|The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR. Data is exchanged between the EHR and the CDS that runs the data through algorithms and returns a response with appropriate action to the EHR. The CDS tool, called Peds & TeenBP, includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-HT, stage 1 HT and stage 2 HT range (iv) review of previous HT diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on HT category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.
11131107|NCT01760239|BG001|Baseline|Control|Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
11131108|NCT01760239|BG002|Baseline|Total|Total of all reporting groups
11226858|NCT02378662|OG001|Outcome|Group B|35-45 IU/Kg/day
11131109|NCT01760239|FG000|Participant Flow|Clincal Decision Support (CDS)|The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the electronic health record (EHR). Data is exchanged between the EHR and the CDS that runs the data through algorithms and returns a response with appropriate action to the EHR. The CDS tool, includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-hypertension, stage 1 hypertension and stage 2 hypertension range (iv) review of previous hypertension diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on hypertension category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.
11131110|NCT01760239|FG001|Participant Flow|Control|Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
11131111|NCT01760239|OG000|Outcome|Clinical Decision Support (CDS)|The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR. Data is exchanged between the EHR and the CDS that runs the data through algorithms and returns a response with appropriate action to the EHR. The CDS tool, called Peds & TeenBP, includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-HT, stage 1 HT and stage 2 HT range (iv) review of previous HT diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on HT category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.
11131112|NCT01760239|OG001|Outcome|Control|Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
11131113|NCT01760239|OG000|Outcome|Clincal Decision Support (CDS)|The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR. Data is exchanged between the EHR and the CDS that runs the data through algorithms and returns a response with appropriate action to the EHR. The CDS tool, called Peds & TeenBP, includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-HT, stage 1 HT and stage 2 HT range (iv) review of previous HT diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on HT category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.
11131114|NCT01760239|EG000|Reported Event|Clincal Decision Support (CDS)|The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR. Data is exchanged between the EHR and the CDS that runs the data through algorithms and returns a response with appropriate action to the EHR. The CDS tool, called Peds & TeenBP, includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-HT, stage 1 HT and stage 2 HT range (iv) review of previous HT diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on HT category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.
11131115|NCT01760239|EG001|Reported Event|Control|Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
11131116|NCT01760304|BG000|Baseline|Budesonide / Formoterol First , Then Placebo|"Subjects received in a blinded fashion Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5) then placebo 2 inhalations Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131117|NCT01760304|BG001|Baseline|Placebo First, Then Budesonide/Formoterol|"Subjects received in a blinded fashion placebo 2 inhalation then Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5)~Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Placebo on visit 1 then Budesonide/formoterol (B/F) 160/4.5 msg per activation on visit 2 (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131118|NCT01760304|BG002|Baseline|Total|Total of all reporting groups
11131119|NCT01760304|FG000|Participant Flow|Budesonide / Formoterol , Then Placebo|"This is a crossover study, where every patient signed to this arm received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) 160/4.5 mcg (2 inhalations) then placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131120|NCT01760304|FG001|Participant Flow|Placebo Then Budesonide/Formoterol|"Every patient in this arm received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® )~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11226859|NCT02378662|EG000|Reported Event|Group A|18-25 IU/Kg/day
11226860|NCT02378662|EG001|Reported Event|Group B|35-45 IU/Kg/day
11131121|NCT01760304|OG000|Outcome|Budesonide / Formoterol|"In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131122|NCT01760304|OG001|Outcome|Placebo|"In this arm patients received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study).~Placebo: On visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131123|NCT01760304|OG000|Outcome|Budesonide / Formoterol|"In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131124|NCT01760304|OG001|Outcome|Placebo|"In this arm patients will received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study)~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131125|NCT01760304|OG000|Outcome|Budesonide / Formoterol|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131126|NCT01760304|OG001|Outcome|Placebo|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131127|NCT01760304|EG000|Reported Event|Budesonide / Formoterol|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131128|NCT01760304|EG001|Reported Event|Placebo|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
11131129|NCT01760447|BG000|Baseline|Sitagliptin/Metformin|Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
11131130|NCT01760447|BG001|Baseline|Metformin|Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
11131131|NCT01760447|BG002|Baseline|Sitagliptin/Metformin XR|Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
11131132|NCT01760447|BG003|Baseline|Metformin XR|Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
11131133|NCT01760447|BG004|Baseline|Total|Total of all reporting groups
11131134|NCT01760447|FG000|Participant Flow|Sitagliptin/Metformin|Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
11131135|NCT01760447|FG001|Participant Flow|Metformin|Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
11131136|NCT01760447|FG002|Participant Flow|Sitagliptin/Metformin XR|Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
11131137|NCT01760447|FG003|Participant Flow|Metformin XR|Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
11131138|NCT01760447|OG000|Outcome|Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled|"This reporting group contains the pooled population of treated participants from the experimental-drug groups Sitagliptin/Metformin (from protocol MK-0431A-170) and Sitagliptin/Metformin XR (from protocol MK-0431A-289)."
11131139|NCT01760447|OG001|Outcome|Metformin and Metformin XR Pooled|"This reporting group contains the pooled population of treated participants from the placebo groups Metformin (from protocol MK-0431A-170) and Metformin XR (from protocol MK-0431A-289)."
11131140|NCT01760447|OG000|Outcome|Sitagliptin/Metformin|Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
11131141|NCT01760447|OG001|Outcome|Metformin|Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
11131142|NCT01760447|OG002|Outcome|Sitagliptin/Metformin XR|Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
11131143|NCT01760447|OG003|Outcome|Metformin XR|Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
11131144|NCT01760447|OG004|Outcome|Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled|"This reporting group contains the pooled population of treated participants from the experimental-drug groups Sitagliptin/Metformin (from protocol MK-0431A-170) and Sitagliptin/Metformin XR (from protocol MK-0431A-289)."
11131145|NCT01760447|OG005|Outcome|Metformin and Metformin XR Pooled|"This reporting group contains the pooled population of treated participants from the placebo groups Metformin (from protocol MK-0431A-170) and Metformin XR (from protocol MK-0431A-289)."
11131146|NCT01760447|EG000|Reported Event|Sitagliptin/Metformin|Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
11131147|NCT01760447|EG001|Reported Event|Metformin|Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
11131148|NCT01760447|EG002|Reported Event|Sitagliptin/Metformin XR|Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
11131149|NCT01760447|EG003|Reported Event|Metformin XR|Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
11131150|NCT01760447|EG004|Reported Event|Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled|"This reporting group contains the pooled population of treated participants from the experimental-drug groups Sitagliptin/Metformin (from protocol MK-0431A-170) and Sitagliptin/Metformin XR (from protocol MK-0431A-289)."
11131151|NCT01760447|EG005|Reported Event|Metformin and Metformin XR Pooled|"This reporting group contains the pooled population of treated participants from the placebo groups Metformin (from protocol MK-0431A-170) and Metformin XR (from protocol MK-0431A-289)."
11131152|NCT01760473|BG000|Baseline|Intranasal Challege Drug|Each of the 9 experimental challenge drugs were administered intranasally to all participants in random order.
11131153|NCT01760473|FG000|Participant Flow|Intranasal Challege Drug|Each of the 9 experimental challenge drugs were administered intranasally to all participants in random order. This study employed a Latin-square randomization procedure, therefore, the testing order of the 9 IN doses was unique for each participant.
11131154|NCT01760473|OG000|Outcome|Bup 8|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
11131155|NCT01760473|OG001|Outcome|Bup 16|"Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
11131156|NCT01760473|OG002|Outcome|Bup/Nal 8/2|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
11131157|NCT01760473|OG003|Outcome|Bup/Nal 8/8|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
11131158|NCT01760473|OG004|Outcome|Bup/Nal 8/16|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
11131159|NCT01760473|OG005|Outcome|Bup/Nal 16/4|"Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
11131160|NCT01760473|OG006|Outcome|Heroin|"Intranasal challenge drug: 24 mg of heroin administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
11131161|NCT01760473|OG007|Outcome|Placebo|"Intranasal challenge drug: Intranasal lactose powder.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
10849114|NCT00294047|OG001|Outcome|Aluminium Hydroxide|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11131162|NCT01760473|OG008|Outcome|Naloxone 4 mg|"Intranasal challenge drug: Intranasal Naloxone 4mg.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
11131163|NCT01760473|EG000|Reported Event|Intranasal Challege Drug|Each of the 9 experimental challenge drugs were administered intranasally to all participants in a randomized order. Therefore, the testing sequence for each of the participants was unique. Although we assessed for some averse events on a daily basis, other measures of health (e.g., blood chemistry) were assessed on a weekly basis. As multiple doses were tested during the week, therefore, in some cases we cannot causally connect some AEs to any individual drug/testing condition.
11131164|NCT01760733|BG000|Baseline|Waiting List|Patients on the waiting list for transplantation
11131165|NCT01760733|FG000|Participant Flow|Patients Accepted for the Transplant Waiting List|Patients accepted for the kidney transplantation waiting list at Oslo University Hospital between Jan 1 2013 and Nov 30 2016 were included and followed from time of acceptance and up to 10 years after transplantation
11131166|NCT01760733|OG000|Outcome|Waitlist|Patients on the waiting list for transplantation
11131167|NCT01760733|OG001|Outcome|Transplanted|Patients who have received a transplant
11131168|NCT01760733|EG000|Reported Event|Question 65|Patients on the waiting list for transplantation - 5 years post KTx Observational study
11131169|NCT01760785|BG000|Baseline|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
11131170|NCT01760785|BG001|Baseline|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
11131171|NCT01760785|BG002|Baseline|Total|Total of all reporting groups
11131172|NCT01760785|FG000|Participant Flow|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
11131173|NCT01760785|FG001|Participant Flow|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
11131174|NCT01760785|OG000|Outcome|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
11131175|NCT01760785|OG001|Outcome|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
11131176|NCT01760785|EG000|Reported Event|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
11131177|NCT01760785|EG001|Reported Event|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
11131178|NCT01760876|BG000|Baseline|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
11131179|NCT01760876|FG000|Participant Flow|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
11131180|NCT01760876|OG000|Outcome|Biofreedom Stent|The healing profile (curve) in terms of percentage strut coverage of the BioFreedom Stent increased from a median of 85.77%, 86.95%, 88.56%, 96.79%, and 97.14% in the first 5 months, to 99.55% at 9 months.
11131181|NCT01760876|EG000|Reported Event|Biofreedom Stent|The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
11131182|NCT01760954|BG000|Baseline|Elagolix/Elagolix 150 mg QD|Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
11131183|NCT01760954|BG001|Baseline|Elagolix/Elagolix 200 mg BID|Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
11131184|NCT01760954|BG002|Baseline|Placebo/Elagolix 150 mg QD|Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
11131185|NCT01760954|BG003|Baseline|Placebo/Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
11131186|NCT01760954|BG004|Baseline|Total|Total of all reporting groups
11131187|NCT01760954|FG000|Participant Flow|Elagolix/Elagolix 150 mg QD|Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
11131188|NCT01760954|FG001|Participant Flow|Elagolix/Elagolix 200 mg BID|Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
11131189|NCT01760954|FG002|Participant Flow|Placebo/Elagolix 150 mg QD|Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
11131190|NCT01760954|FG003|Participant Flow|Placebo/Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
11131191|NCT01760954|OG000|Outcome|Elagolix/Elagolix 150 mg QD|Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
11131192|NCT01760954|OG001|Outcome|Elagolix/Elagolix 200 mg BID|Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
11131193|NCT01760954|OG002|Outcome|Placebo/Elagolix 150 mg QD|Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
11131194|NCT01760954|OG003|Outcome|Placebo/Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
11131195|NCT01760954|EG000|Reported Event|Elagolix/Elagolix 150 mg QD|Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
11131196|NCT01760954|EG001|Reported Event|Elagolix/Elagolix 200 mg BID|Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
11131197|NCT01760954|EG002|Reported Event|Placebo/Elagolix 150 mg QD|Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
11131198|NCT01760954|EG003|Reported Event|Placebo/Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
11131199|NCT01761019|BG000|Baseline|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
11131200|NCT01761019|FG000|Participant Flow|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
11131201|NCT01761019|OG000|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
11131202|NCT01761019|EG000|Reported Event|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
11149568|NCT01871519|FG000|Participant Flow|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
11131203|NCT01761084|BG000|Baseline|Exercise and Behaviour Change Strategies|"The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.~Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day."
11131204|NCT01761084|BG001|Baseline|General Health or Social Discussion|Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
11131205|NCT01761084|BG002|Baseline|Total|Total of all reporting groups
11131206|NCT01761084|FG000|Participant Flow|Exercise and Behaviour Change Strategies|"The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.~Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day."
11131207|NCT01761084|FG001|Participant Flow|General Health or Social Discussion|Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
11131208|NCT01761084|OG000|Outcome|Exercise and Behaviour Change Strategies|"The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.~Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day."
11131209|NCT01761084|OG001|Outcome|General Health or Social Discussion|Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
11131210|NCT01761084|OG000|Outcome|Participants Screened|
11131211|NCT01761084|EG000|Reported Event|Exercise and Behaviour Change Strategies|"The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.~Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day."
11131212|NCT01761084|EG001|Reported Event|General Health or Social Discussion|Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
11131213|NCT01761162|BG000|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
11131214|NCT01761162|FG000|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
11131215|NCT01761162|OG000|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
11131216|NCT01761162|EG000|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
11131217|NCT01761175|BG000|Baseline|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
11131218|NCT01761175|BG001|Baseline|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
11131219|NCT01761175|BG002|Baseline|Total|Total of all reporting groups
11131220|NCT01761175|FG000|Participant Flow|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
11131221|NCT01761175|FG001|Participant Flow|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
11131222|NCT01761175|OG000|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
11131223|NCT01761175|OG001|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
11131224|NCT01761175|OG000|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
11131225|NCT01761175|EG000|Reported Event|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
11131226|NCT01761175|EG001|Reported Event|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
11131227|NCT01761279|BG000|Baseline|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
11131228|NCT01761279|FG000|Participant Flow|HDWL and i-Scan Assessment|High Definition White Light Endoscopy.
11131229|NCT01761279|OG000|Outcome|HDWL|High Definition White Light Endoscopy
11131230|NCT01761279|OG001|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
11131231|NCT01761279|EG000|Reported Event|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
11131232|NCT01761292|BG000|Baseline|ITF2357 25 mg BID|"Givinostat, oral suspension 10 mg/mL, administered orally under fed conditions at the dose of 25 mg BID, during Part 1 and 25 mg BID during Part 2 and during Extension 1.~The dosage was modified as per patient's weight during Extensions 2 and 3."
11131233|NCT01761292|BG001|Baseline|ITF2357 50 mg BID|"Givinostat oral capsules 50 mg, administered orally under fed conditions at the dose of 50 mg BID during Part 1.~The dosage was modified as per patient's weight during Extensions 2 and 3."
11131234|NCT01761292|BG002|Baseline|ITF2357 37.5 mg BID|"Givinostat, oral suspension 10 mg/mL, administered orally under fed conditions at the dose of 37.5 mg BID during Part 1 and 37.5 mg BID during Part 2 and during Extension 1.~The dosage was modified as per patient's weight during Extensions 2 and 3."
11131235|NCT01761292|BG003|Baseline|Total|Total of all reporting groups
11131236|NCT01761292|FG000|Participant Flow|Givinostat|"Givinostat will be administered as 2 oral doses daily while the child is in fed state.~Givinostat: Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, administered orally under fed conditions at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1 and 25 mg BID and 37.5 mg BID during Part 2. Givinostat, oral suspension 10 mg/mL, administered orally under fed conditions at the dose of 25 mg BID or 37.5 mg BID during Extension 1, and modified as per patient's weight during Extensions 2 and 3."
11131237|NCT01761292|OG000|Outcome|Overall|"Givinostat was administered as 2 oral doses daily while the child is in fed state.~Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2."
11131238|NCT01761292|OG000|Outcome|Baseline|"Givinostat was administered as 2 oral doses daily while the child is in fed state.~Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2."
11131239|NCT01761292|OG000|Outcome|Overall|"Givinostat was administered as 2 oral doses daily while the child is in fed state.~Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.~Givinostat oral suspension 10 mg/mL was administered orally at the dose of 25 mg BID or 37.5 mg BID during Extension 1; the dose was modified as per patient's weight during Extensions 2 and 3."
11131240|NCT01761292|EG000|Reported Event|Part 1 - 25 mg|"The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.~19 patients were included in the safety population of Part 1."
11131241|NCT01761292|EG001|Reported Event|Part 1 - 50 mg|"The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.~19 patients were included in the safety population of Part 1."
11131242|NCT01761292|EG002|Reported Event|Part 1 - 37.5 mg|"The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.~19 patients were included in the safety population of Part 1."
11131243|NCT01761292|EG003|Reported Event|Part 2 - 37.5 mg|"The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.~19 patients were included in the safety population of Part 2."
11131244|NCT01761292|EG004|Reported Event|Part 2 - 25 mg|"The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.~19 patients were included in the safety population of Part 2."
11131245|NCT01761292|EG005|Reported Event|Overall (Part 1 + Part 2 + Extensions 1, 2, 3 )|"The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.~19 patients were included in the safety population of Part 1 and 19 patients were included in the safety population of Part 2.~In all Extensions, the Safety Analysis Population was set up to 20 patients (100%), including all patients who received any investigational product."
11131246|NCT01761565|BG000|Baseline|One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg~Single dose of SUF NT 15 mcg~Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg~40 consecutive doses of SUF NT 15 mcg"
11131247|NCT01761565|FG000|Participant Flow|Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg~Subjects received oral naltrexone 50 mg approximately 14 and 2 hours before and 10 hours after the SUF NT dosing~Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg~Subjects received oral naltrexone 50 mg approximately 2 hours before and 10, 22, and 34 hours after the first dose of SUF NT in Period 2."
11131248|NCT01761565|OG000|Outcome|Single Dose of SUF NT 15 mcg|
11131249|NCT01761565|OG001|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
11131250|NCT01761565|OG000|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
11131251|NCT01761565|OG000|Outcome|Single Dose of SUF NT 15 mcg|Arm 1/Period 1: Single dose of SUF NT 15 mcg
11131252|NCT01761565|EG000|Reported Event|Single Dose of SUF NT 15 mcg|
11131253|NCT01761565|EG001|Reported Event|40 Consecutive Doses of SUF NT 15 mcg|
11131254|NCT01761643|BG000|Baseline|Standard of Care (SoC)|Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)
11131255|NCT01761643|BG001|Baseline|SoC + iTab|Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
11131256|NCT01761643|BG002|Baseline|Total|Total of all reporting groups
11131257|NCT01761643|FG000|Participant Flow|Standard of Care (SoC)|Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)
11131258|NCT01761643|FG001|Participant Flow|SoC + iTab|Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
11131259|NCT01761643|OG000|Outcome|Standard of Care (SoC)|Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)
11131260|NCT01761643|OG001|Outcome|SoC + iTab|Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
11131261|NCT01761643|EG000|Reported Event|Standard of Care (SoC)|Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)
11131262|NCT01761643|EG001|Reported Event|SoC + iTab|Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
11131263|NCT01761747|BG000|Baseline|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
11131264|NCT01761747|FG000|Participant Flow|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
11131265|NCT01761747|OG000|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
11131266|NCT01761747|EG000|Reported Event|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
11131267|NCT01762059|BG000|Baseline|All Participants|
11131268|NCT01762059|FG000|Participant Flow|All Participants: Bi-hormonal Bionic Pancreas and Usual Care|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.~After the first experimental period, there was a two-day washout period followed by the second experimental period.~Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM~Usual care"
11131269|NCT01762059|OG000|Outcome|Bionic Pancreas|Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .
11131270|NCT01762059|OG000|Outcome|Bionic Pancreas|
11131271|NCT01762059|OG000|Outcome|Bi-homonal Bionic Pancreas|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.~Bi-homonal Bionic Pancreas: A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor."
11149569|NCT01871519|OG000|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
11131272|NCT01762059|OG000|Outcome|All Participants: Bi-hormonal Bionic Pancreas and Usual Care|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.~After the first experimental period, there was a two-day washout period followed by the second experimental period.~Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM~Usual care"
11131273|NCT01762059|OG000|Outcome|All Participants|
11131274|NCT01762059|OG001|Outcome|Usual Care|
11131275|NCT01762059|EG000|Reported Event|Bionic Pancreas (Closed Loop)|
11131276|NCT01762345|BG000|Baseline|Pessary Device|pessary (disposable intra-vaginal device)
11131277|NCT01762345|FG000|Participant Flow|Pessary Device|pessary (disposable intra-vaginal device)
11131278|NCT01762345|OG000|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
11131279|NCT01762345|OG000|Outcome|Pessary Device|"pessary (disposable intra-vaginal device)~pessary (disposable intra-vaginal device): pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble"
11131280|NCT01762345|EG000|Reported Event|Pessary Device|pessary (disposable intra-vaginal device)
11131281|NCT01762501|BG000|Baseline|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
11131282|NCT01762501|BG001|Baseline|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
11131283|NCT01762501|BG002|Baseline|Total|Total of all reporting groups
11131284|NCT01762501|FG000|Participant Flow|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
11131285|NCT01762501|FG001|Participant Flow|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
11131286|NCT01762501|OG000|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
11131287|NCT01762501|OG001|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
11131288|NCT01762501|EG000|Reported Event|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
11131289|NCT01762501|EG001|Reported Event|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
11131290|NCT01762631|BG000|Baseline|Study Participants In Cohort 1|No intervention- time frame of visits determined Cohort 1 vs Cohort 2
11131291|NCT01762631|BG001|Baseline|Study Participants in Cohort 2|No intervention- time frame of visits determined Cohort 1 vs Cohort 2
11131292|NCT01762631|BG002|Baseline|Total|Total of all reporting groups
11131293|NCT01762631|FG000|Participant Flow|Study Participants in Cohort 1|No intervention, time frame of visit determined Cohort 1 vs Cohort 2
11131294|NCT01762631|FG001|Participant Flow|Study Participants in Cohort 2|No intervention, time frame of visit determined Cohort 1 vs Cohort 2
11131295|NCT01762631|OG000|Outcome|Study Participants in Cohort 1|No intervention, time frame of visit determined Cohort 1 vs Cohort 2
11131296|NCT01762631|OG001|Outcome|Study Participants in Cohort 2|No intervention, time frame of visit determined Cohort 1 vs Cohort 2
11131297|NCT01762631|EG000|Reported Event|Study Participants in Cohort 1|No intervention, time frame of visit determined Cohort 1 vs Cohort 2
11131298|NCT01762631|EG001|Reported Event|Study Participants in Cohort 2|No intervention, time frame of visit determined Cohort 1 vs Cohort 2
11131299|NCT01762722|BG000|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
11131300|NCT01762722|BG001|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
11131301|NCT01762722|BG002|Baseline|Total|Total of all reporting groups
11131302|NCT01762722|FG000|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
11131303|NCT01762722|FG001|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
11131304|NCT01762722|OG000|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
11131305|NCT01762722|OG001|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
11131306|NCT01762722|EG000|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
11131307|NCT01762722|EG001|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
11131308|NCT01762800|BG000|Baseline|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
11131309|NCT01762800|BG001|Baseline|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
11131310|NCT01762800|BG002|Baseline|Total|Total of all reporting groups
11131311|NCT01762800|FG000|Participant Flow|TIO 18 µg QD|Participants received 18 micrograms (µg) tiotropium bromide (TIO) once daily (QD) via HandiHaler inhaler and placebo twice daily (BID) via dry powder inhaler (DPI), during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
11131312|NCT01762800|FG001|Participant Flow|SAL/FLU 50/250 µg BID|Participants received 50/250 µg salmeterol xinafoate (SAL)/fluticasone propionate (FLU) BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
11131313|NCT01762800|OG000|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
11131314|NCT01762800|OG001|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
11131315|NCT01762800|OG000|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
11131316|NCT01762800|OG001|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
11131317|NCT01762800|OG002|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
11131318|NCT01762800|OG003|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
11131319|NCT01762800|EG000|Reported Event|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
11131320|NCT01762800|EG001|Reported Event|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
11131321|NCT01762800|EG002|Reported Event|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
11131322|NCT01762800|EG003|Reported Event|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
11131323|NCT01762904|BG000|Baseline|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.~The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.~Interventions:~Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls~Other: Preparing skin's areas to be tested with two antiseptics and two controls"
11131324|NCT01762904|FG000|Participant Flow|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.~The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.~Interventions:~Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls~Other: Preparing skin's areas to be tested with two antiseptics and two controls"
11131325|NCT01762904|OG000|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
11149570|NCT01871519|OG000|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices"
11131326|NCT01762904|OG000|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
11131327|NCT01762904|OG000|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test two controls: Deionized water redistilled and Scrub the skin without prior application of any substance was tested.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled and Scrub the skin without prior application of any substance was tested.~Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
11131328|NCT01762904|OG000|Outcome|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
11131329|NCT01762904|EG000|Reported Event|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
11131330|NCT01762943|BG000|Baseline|Women With Postpartum Depression (PPD)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
11131331|NCT01762943|BG001|Baseline|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
11131332|NCT01762943|BG002|Baseline|Total|Total of all reporting groups
11131333|NCT01762943|FG000|Participant Flow|Women With Postpartum Depression (PPD)|"4 monthly intramuscular (IM) injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
11131334|NCT01762943|FG001|Participant Flow|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
11131335|NCT01762943|OG000|Outcome|Women With a History of Postpartum Depression (PPD)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
11131336|NCT01762943|OG001|Outcome|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
11131337|NCT01762943|EG000|Reported Event|Women With Postpartum Depression (PPD)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
11131338|NCT01762943|EG001|Reported Event|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
11131339|NCT01762982|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
11131340|NCT01762982|FG000|Participant Flow|Overall|This was a 4-way split-plot clinical study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 milliliters (mL) of 0.13% Benazalkonium chloride solution), one positive control [Sodium lauryl sulphate (SLS); 0.03 mL of 0.3% weight by weight (w/w) SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% weight by volume (w/v) normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.
11131341|NCT01762982|OG000|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
11131342|NCT01762982|OG001|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
11131343|NCT01762982|OG002|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
11131344|NCT01762982|OG003|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
11131345|NCT01762982|OG001|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
11131346|NCT01762982|EG000|Reported Event|Overall Study|"This was a 4-way split-plot study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 mL of 0.13% Benazalkonium chloride solution), one positive control [SLS; 0.03 mL of 0.3% w/w SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% w/v normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.~All randomized participants exposed to at least one of the study treatments were evaluated for safety."
11131347|NCT01763047|BG000|Baseline|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B.
11131348|NCT01763047|BG001|Baseline|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A.
11131349|NCT01763047|BG002|Baseline|Total|Total of all reporting groups
11131350|NCT01763047|FG000|Participant Flow|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens.
11131351|NCT01763047|FG001|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
11131352|NCT01763047|OG000|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
11131353|NCT01763047|OG001|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
11131354|NCT01763047|OG001|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study.
11131355|NCT01763047|OG000|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
11131356|NCT01763047|OG001|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
11131357|NCT01763047|EG000|Reported Event|Test (Etafilcon A)|Subjects that were dispensed the Test lens (etafilcon A) during either the first or second period of the study.
11131358|NCT01763047|EG001|Reported Event|Control (Lotrafilcon B)|Subjects that were dispensed the Control lens (lotrafilcon B) during either the first or second period of the study.
11131359|NCT01763164|BG000|Baseline|Binimetinib (MEK162)|Participants received oral binimetinib 45 milligram (mg) (3*15 mg tablets) twice daily, until disease progression (PD), unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of binimetinib treatment exposure in the study was 215.4 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per Blinded Independent Review Committee (BIRC), withdrawal of consent, lost to follow-up, study closure or death whichever occurred first.
11131360|NCT01763164|BG001|Baseline|Dacarbazine|Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first.
11131361|NCT01763164|BG002|Baseline|Total|Total of all reporting groups
11131362|NCT01763164|FG000|Participant Flow|Binimetinib (MEK162)|Participants received oral binimetinib 45 milligram (mg) (3*15 mg tablets) twice daily, until disease progression (PD), unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of binimetinib treatment exposure in the study was 215.4 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per Blinded Independent Review Committee (BIRC), withdrawal of consent, lost to follow-up, study closure or death whichever occurred first.
11131363|NCT01763164|FG001|Participant Flow|Dacarbazine|Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first.
11131364|NCT01763164|OG000|Outcome|Binimetinib (MEK162)|Participants received oral binimetinib 45 milligram (mg) (3*15 mg tablets) twice daily, until disease progression (PD), unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of binimetinib treatment exposure in the study was 215.4 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per Blinded Independent Review Committee (BIRC), withdrawal of consent, lost to follow-up, study closure or death whichever occurred first.
11131365|NCT01763164|OG001|Outcome|Dacarbazine|Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first.
11131366|NCT01763164|EG000|Reported Event|Binimetinib (MEK162)|Participants received oral binimetinib 45 milligram (mg) (3*15 mg tablets) twice daily, until disease progression (PD), unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of binimetinib treatment exposure in the study was 215.4 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per Blinded Independent Review Committee (BIRC), withdrawal of consent, lost to follow-up, study closure or death whichever occurred first.
11131367|NCT01763164|EG001|Reported Event|Dacarbazine|Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first.
11131368|NCT01763203|BG000|Baseline|Care Management+Community Health Worker|"Care management~Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology."
11131369|NCT01763203|BG001|Baseline|Usual Care|"Written materials~Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual."
11131370|NCT01763203|BG002|Baseline|Total|Total of all reporting groups
11131371|NCT01763203|FG000|Participant Flow|Care Management+Community Health Worker|"Care management~Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology."
11131372|NCT01763203|FG001|Participant Flow|Usual Care|"Written materials~Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual."
11131373|NCT01763203|OG000|Outcome|Care Management+Community Health Worker|"Care management~Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology."
11131374|NCT01763203|OG001|Outcome|Usual Care|"Written materials~Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual."
11131375|NCT01763203|EG000|Reported Event|Care Management+Community Health Worker|"Care management~Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology."
10849115|NCT00294047|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11131376|NCT01763203|EG001|Reported Event|Usual Care|"Written materials~Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual."
11131377|NCT01763333|BG000|Baseline|BI 1026706 - Tablet 25 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
11131378|NCT01763333|BG001|Baseline|BI 1026706 - Tablet 50 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
11131379|NCT01763333|BG002|Baseline|BI 1026706 - Tablet 100 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
11131380|NCT01763333|BG003|Baseline|BI 1026706 - Tablet 200 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
11131381|NCT01763333|BG004|Baseline|BI 1026706 - Tablet 400 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
11131382|NCT01763333|BG005|Baseline|BI 1026706 - Solution 10 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
11131383|NCT01763333|BG006|Baseline|BI 1026706 - Solution 100 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
11131384|NCT01763333|BG007|Baseline|BI 1026706 - Solution 200 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
11131385|NCT01763333|BG008|Baseline|BI 1026706 - Solution 400 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
11131386|NCT01763333|BG009|Baseline|Placebo (SRD - Part)|Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
11131387|NCT01763333|BG010|Baseline|R1/T1/R2/T2 (BA - Part)|Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100mg film coated tablet (R1) under fasted condition, followed by 100mg film coated tablet (T1) under fed condition, 100 mg drinking solution (R2) under fasting and in the last treatment period with 100 mg drinking solution (T2) under fed condition. There was washout period of 7days between the respective treatments.
11131388|NCT01763333|BG011|Baseline|T1/T2/R1/R2 (BA - Part)|Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning. First they were treated with 100mg film coated tablet (T1) under fed condition, followed by 100 mg drinking solution (T2) under fed condition, 100mg film coated tablet (R1) under fasted condition and in the last treatment period with 100 mg drinking solution (R2) under fasting condition. There was a washout period of 7days between the respective treatments.
11131389|NCT01763333|BG012|Baseline|R2/R1/T2/T1 (BA - Part)|Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (R2) under fasting condition, followed by 100mg film coated tablet (R1) under fasted condition,100 mg drinking solution (T2) under fed condition and in the last treatment period with 100mg film coated tablet (T1) under fed condition. There was washout period of 7days between the respective treatments.
11131390|NCT01763333|BG013|Baseline|T2/R2/T1/R1 (BA - Part)|Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (T2) under fed condition, followed by 100 mg drinking solution (R2) under fasting, 100mg film coated tablet (T1) under fed condition and in the last treatment period with 100mg film coated tablet (R1) under fasted condition. There was washout period of 7days between the respective treatments.
11131391|NCT01763333|BG014|Baseline|Total|Total of all reporting groups
11131392|NCT01763333|FG000|Participant Flow|BI 1026706 - Tablet 25 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
11131393|NCT01763333|FG001|Participant Flow|BI 1026706 - Tablet 50 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
11131394|NCT01763333|FG002|Participant Flow|BI 1026706 - Tablet 100 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
11131395|NCT01763333|FG003|Participant Flow|BI 1026706 - Tablet 200 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
11131396|NCT01763333|FG004|Participant Flow|BI 1026706 - Tablet 400 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
11131397|NCT01763333|FG005|Participant Flow|BI 1026706 - Solution 10 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
11131398|NCT01763333|FG006|Participant Flow|BI 1026706 - Solution 100 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
11131399|NCT01763333|FG007|Participant Flow|BI 1026706 - Solution 200 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
11131400|NCT01763333|FG008|Participant Flow|BI 1026706 - Solution 400 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
11131401|NCT01763333|FG009|Participant Flow|Placebo (SRD - Part)|Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
11131402|NCT01763333|FG010|Participant Flow|R1/T1/R2/T2 (BA - Part)|Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100mg film coated tablet (R1) under fasted condition, followed by 100mg film coated tablet (T1) under fed condition, 100 mg drinking solution (R2) under fasting and in the last treatment period with 100 mg drinking solution (T2) under fed condition. There was washout period of 7days between the respective treatments.
11131403|NCT01763333|FG011|Participant Flow|T1/T2/R1/R2 (BA - Part)|Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning. First they were treated with 100mg film coated tablet (T1) under fed condition, followed by 100 mg drinking solution (T2) under fed condition, 100mg film coated tablet (R1) under fasted condition and in the last treatment period with 100 mg drinking solution (R2) under fasting condition. There was a washout period of 7days between the respective treatments.
11131404|NCT01763333|FG012|Participant Flow|R2/R1/T2/T1 (BA - Part)|Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (R2) under fasting condition, followed by 100mg film coated tablet (R1) under fasted condition,100 mg drinking solution (T2) under fed condition and in the last treatment period with 100mg film coated tablet (T1) under fed condition. There was washout period of 7days between the respective treatments.
11131405|NCT01763333|FG013|Participant Flow|T2/R2/T1/R1 (BA - Part)|Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (T2) under fed condition, followed by 100 mg drinking solution (R2) under fasting, 100mg film coated tablet (T1) under fed condition and in the last treatment period with 100mg film coated tablet (R1) under fasted condition. There was washout period of 7days between the respective treatments.
11131406|NCT01763333|OG000|Outcome|BI 1026706 - Tablet 25 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
11131407|NCT01763333|OG001|Outcome|BI 1026706 - Tablet 50 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
11131408|NCT01763333|OG002|Outcome|BI 1026706 - Tablet 100 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
11131409|NCT01763333|OG003|Outcome|BI 1026706 - Tablet 200 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
11131410|NCT01763333|OG004|Outcome|BI 1026706 - Tablet 400 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
11131411|NCT01763333|OG005|Outcome|BI 1026706 - Solution 10 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
11131412|NCT01763333|OG006|Outcome|BI 1026706 - Solution 100 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
11131413|NCT01763333|OG007|Outcome|BI 1026706 - Solution 200 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
11131414|NCT01763333|OG008|Outcome|BI 1026706 - Solution 400 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
11131415|NCT01763333|OG009|Outcome|Placebo (SRD - Part)|Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
11131416|NCT01763333|OG010|Outcome|BI 1026706 - Solution 100 mg Fasted (R2)|Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
11131417|NCT01763333|OG011|Outcome|BI 1026706 - 100 mg Solution Fed (T2)|Subjects were treated with 100 mg drinking solution (T2) under fed condition.
11131418|NCT01763333|OG012|Outcome|BI 1026706 - Tablet 100 mg Fasted (R1)|Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
11131419|NCT01763333|OG013|Outcome|BI 1026706 - Tablet 100 mg Fed (T1)|Subjects were treated with 100mg film coated tablet (T1) under fed condition.
11131420|NCT01763333|OG009|Outcome|BI 1026706 - Solution 100 mg Fasted (R2)|Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
11131421|NCT01763333|OG010|Outcome|BI 1026706 - 100 mg Solution Fed (T2)|Subjects were treated with 100 mg drinking solution (T2) under fed condition.
11131422|NCT01763333|OG011|Outcome|BI 1026706 - Tablet 100 mg Fasted (R1)|Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
11131423|NCT01763333|OG012|Outcome|BI 1026706 - Tablet 100 mg Fed (T1)|Subjects were treated with 100mg film coated tablet (T1) under fed condition.
11131424|NCT01763333|EG000|Reported Event|BI 1026706 - Tablet 25 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
11131425|NCT01763333|EG001|Reported Event|BI 1026706 - Tablet 50 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
11131426|NCT01763333|EG002|Reported Event|BI 1026706 - Tablet 100 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
11131427|NCT01763333|EG003|Reported Event|BI 1026706 - Tablet 200 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
11131428|NCT01763333|EG004|Reported Event|BI 1026706 - Tablet 400 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
11131429|NCT01763333|EG005|Reported Event|BI 1026706 - Solution 10 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
11131430|NCT01763333|EG006|Reported Event|BI 1026706 - Solution 100 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition.
11131431|NCT01763333|EG007|Reported Event|BI 1026706 - Solution 200 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
11131432|NCT01763333|EG008|Reported Event|BI 1026706 - Solution 400 mg (SRD - Part)|Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
11131433|NCT01763333|EG009|Reported Event|Placebo (SRD - Part)|Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
11131434|NCT01763333|EG010|Reported Event|BI 1026706 - Solution 100 mg Fasted (R2)|Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
11131435|NCT01763333|EG011|Reported Event|BI 1026706 - 100 mg Solution Fed (T2)|Subjects were treated with 100 mg drinking solution (T2) under fed condition.
11131436|NCT01763333|EG012|Reported Event|BI 1026706 - Tablet 100 mg Fasted (R1)|Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
11131437|NCT01763333|EG013|Reported Event|BI 1026706 - Tablet 100 mg Fed (T1)|Subjects were treated with 100mg film coated tablet (T1) under fed condition.
11131438|NCT01763346|BG000|Baseline|Metformin|"subjects receiving metformin~Metformin: metformin 1000 mg bid"
11131439|NCT01763346|BG001|Baseline|Gastric Banding|"subjects receiving LAP-BAND~gastric banding: LAP-BAND"
11131440|NCT01763346|BG002|Baseline|Total|Total of all reporting groups
11131441|NCT01763346|FG000|Participant Flow|Metformin|"subjects receiving metformin~Metformin: metformin 1000 mg bid"
11131442|NCT01763346|FG001|Participant Flow|Gastric Banding|"subjects receiving LAP-BAND~gastric banding: LAP-BAND"
11131443|NCT01763346|OG000|Outcome|Metformin|"subjects receiving metformin~Metformin: metformin 1000 mg bid"
11131444|NCT01763346|OG001|Outcome|Gastric Banding|"subjects receiving LAP-BAND~gastric banding: LAP-BAND"
11131445|NCT01763346|EG000|Reported Event|Metformin|"subjects receiving metformin~Metformin: metformin 1000 mg bid"
11131446|NCT01763346|EG001|Reported Event|Gastric Banding|"subjects receiving LAP-BAND~gastric banding: LAP-BAND"
11131447|NCT01763567|BG000|Baseline|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
11131448|NCT01763567|FG000|Participant Flow|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
11131449|NCT01763567|OG000|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
11131450|NCT01763567|EG000|Reported Event|Observation Arm|To assess safety and device performance for the Hospital Glucose Managment system
11131451|NCT01763606|BG000|Baseline|Enoxaparin|"Patients assigned to enoxaparin.~Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change."
11131452|NCT01763606|BG001|Baseline|Aspirin|"Patients assigned to Aspirin.~Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day)."
11131453|NCT01763606|BG002|Baseline|Total|Total of all reporting groups
11131454|NCT01763606|FG000|Participant Flow|Enoxaparin|"Patients assigned to enoxaparin.~Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change."
11131455|NCT01763606|FG001|Participant Flow|Aspirin|"Patients assigned to Aspirin.~Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day)."
11131456|NCT01763606|OG000|Outcome|Enoxaparin|"Patients assigned to enoxaparin.~Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change."
11131457|NCT01763606|OG001|Outcome|Aspirin|"Patients assigned to Aspirin.~Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day)."
11131458|NCT01763606|OG000|Outcome|Eligible Participants|Participants eligible for study
11131459|NCT01763606|EG000|Reported Event|Enoxaparin|"Patients assigned to enoxaparin.~Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change."
11131460|NCT01763606|EG001|Reported Event|Aspirin|"Patients assigned to Aspirin.~Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day)."
11131461|NCT01763645|BG000|Baseline|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
11131462|NCT01763645|BG001|Baseline|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.~Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
11131463|NCT01763645|BG002|Baseline|Total|Total of all reporting groups
11131464|NCT01763645|FG000|Participant Flow|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
11131465|NCT01763645|FG001|Participant Flow|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
11131466|NCT01763645|OG000|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
11131467|NCT01763645|OG001|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.~Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
11131468|NCT01763645|OG001|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
11131469|NCT01763645|EG000|Reported Event|BCD-021 (CISC BIOCAD)|"In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.~Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
11131470|NCT01763645|EG001|Reported Event|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.~Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
11131471|NCT01763684|BG000|Baseline|Signature Custom Guides|"Oxford Partial Knee implanted using Signature Custom Guides~Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI)."
11131472|NCT01763684|BG001|Baseline|Conventional Instrumentation|"Oxford Partial Knee implanted using Conventional Instrumentation~Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology."
11131473|NCT01763684|BG002|Baseline|Total|Total of all reporting groups
11131474|NCT01763684|FG000|Participant Flow|Signature Custom Guides|"Oxford Partial Knee implanted using Signature Custom Guides~Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI)."
11131475|NCT01763684|FG001|Participant Flow|Conventional Instrumentation|"Oxford Partial Knee implanted using Conventional Instrumentation~Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology."
11131476|NCT01763684|OG000|Outcome|Signature Custom Guides|"Oxford Partial Knee implanted using Signature Custom Guides~Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI)."
11131477|NCT01763684|OG001|Outcome|Conventional Instrumentation|"Oxford Partial Knee implanted using Conventional Instrumentation~Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology."
11131478|NCT01763684|EG000|Reported Event|Signature Custom Guides|"Oxford Partial Knee implanted using Signature Custom Guides~Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI)."
11131479|NCT01763684|EG001|Reported Event|Conventional Instrumentation|"Oxford Partial Knee implanted using Conventional Instrumentation~Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology."
11131480|NCT01763827|BG000|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
11131481|NCT01763827|BG001|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
11131482|NCT01763827|BG002|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131483|NCT01763827|BG003|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131484|NCT01763827|BG004|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
11131485|NCT01763827|BG005|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
11131486|NCT01763827|BG006|Baseline|Total|Total of all reporting groups
11131487|NCT01763827|FG000|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
11131488|NCT01763827|FG001|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
11131489|NCT01763827|FG002|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131490|NCT01763827|FG003|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131491|NCT01763827|FG004|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
11131492|NCT01763827|FG005|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
11131493|NCT01763827|OG000|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
11131494|NCT01763827|OG001|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
11131495|NCT01763827|OG002|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131496|NCT01763827|OG003|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131497|NCT01763827|OG004|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
11131498|NCT01763827|OG005|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
11131499|NCT01763827|EG000|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
11131500|NCT01763827|EG001|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
11131501|NCT01763827|EG002|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131502|NCT01763827|EG003|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131503|NCT01763827|EG004|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
11131504|NCT01763827|EG005|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
11131505|NCT01763866|BG000|Baseline|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
11131506|NCT01763866|BG001|Baseline|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
11131507|NCT01763866|BG002|Baseline|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
11131508|NCT01763866|BG003|Baseline|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131509|NCT01763866|BG004|Baseline|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131510|NCT01763866|BG005|Baseline|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131511|NCT01763866|BG006|Baseline|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131512|NCT01763866|BG007|Baseline|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131513|NCT01763866|BG008|Baseline|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131514|NCT01763866|BG009|Baseline|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131515|NCT01763866|BG010|Baseline|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131516|NCT01763866|BG011|Baseline|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131517|NCT01763866|BG012|Baseline|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131518|NCT01763866|BG013|Baseline|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131519|NCT01763866|BG014|Baseline|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131520|NCT01763866|BG015|Baseline|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131521|NCT01763866|BG016|Baseline|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131522|NCT01763866|BG017|Baseline|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131523|NCT01763866|BG018|Baseline|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131524|NCT01763866|BG019|Baseline|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131525|NCT01763866|BG020|Baseline|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131526|NCT01763866|BG021|Baseline|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131527|NCT01763866|BG022|Baseline|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131528|NCT01763866|BG023|Baseline|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131529|NCT01763866|BG024|Baseline|Total|Total of all reporting groups
11131530|NCT01763866|FG000|Participant Flow|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
11131531|NCT01763866|FG001|Participant Flow|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
11131532|NCT01763866|FG002|Participant Flow|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
11131533|NCT01763866|FG003|Participant Flow|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131534|NCT01763866|FG004|Participant Flow|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131535|NCT01763866|FG005|Participant Flow|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131536|NCT01763866|FG006|Participant Flow|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131537|NCT01763866|FG007|Participant Flow|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131538|NCT01763866|FG008|Participant Flow|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131539|NCT01763866|FG009|Participant Flow|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131540|NCT01763866|FG010|Participant Flow|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131541|NCT01763866|FG011|Participant Flow|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131542|NCT01763866|FG012|Participant Flow|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131543|NCT01763866|FG013|Participant Flow|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131544|NCT01763866|FG014|Participant Flow|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131545|NCT01763866|FG015|Participant Flow|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131546|NCT01763866|FG016|Participant Flow|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131547|NCT01763866|FG017|Participant Flow|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131548|NCT01763866|FG018|Participant Flow|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131549|NCT01763866|FG019|Participant Flow|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131550|NCT01763866|FG020|Participant Flow|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131551|NCT01763866|FG021|Participant Flow|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131552|NCT01763866|FG022|Participant Flow|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131553|NCT01763866|FG023|Participant Flow|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131554|NCT01763866|OG000|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
11131555|NCT01763866|OG001|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
11131556|NCT01763866|OG002|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
11131557|NCT01763866|OG003|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131558|NCT01763866|OG004|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131559|NCT01763866|OG005|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131560|NCT01763866|OG006|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131561|NCT01763866|OG007|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131562|NCT01763866|OG008|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131563|NCT01763866|OG009|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
10849029|NCT00293267|EG000|Reported Event|Raltegravir 400 mg b.i.d Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who~continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
11131564|NCT01763866|OG010|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131565|NCT01763866|OG011|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131566|NCT01763866|OG012|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131567|NCT01763866|OG013|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131568|NCT01763866|OG014|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131569|NCT01763866|OG015|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131570|NCT01763866|OG016|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131571|NCT01763866|OG017|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131572|NCT01763866|OG018|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131573|NCT01763866|OG019|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131574|NCT01763866|OG020|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131575|NCT01763866|OG021|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131576|NCT01763866|OG022|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131577|NCT01763866|OG023|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131578|NCT01763866|EG000|Reported Event|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
11131579|NCT01763866|EG001|Reported Event|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
11131580|NCT01763866|EG002|Reported Event|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
11131581|NCT01763866|EG003|Reported Event|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131582|NCT01763866|EG004|Reported Event|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131583|NCT01763866|EG005|Reported Event|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131584|NCT01763866|EG006|Reported Event|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131585|NCT01763866|EG007|Reported Event|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131586|NCT01763866|EG008|Reported Event|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131587|NCT01763866|EG009|Reported Event|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
11131588|NCT01763866|EG010|Reported Event|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
11131589|NCT01763866|EG011|Reported Event|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
11131590|NCT01763866|EG012|Reported Event|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131591|NCT01763866|EG013|Reported Event|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131592|NCT01763866|EG014|Reported Event|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131593|NCT01763866|EG015|Reported Event|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131594|NCT01763866|EG016|Reported Event|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131595|NCT01763866|EG017|Reported Event|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131596|NCT01763866|EG018|Reported Event|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131597|NCT01763866|EG019|Reported Event|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131598|NCT01763866|EG020|Reported Event|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
11131599|NCT01763866|EG021|Reported Event|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
11131600|NCT01763866|EG022|Reported Event|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131601|NCT01763866|EG023|Reported Event|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131602|NCT01763905|BG000|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131603|NCT01763905|BG001|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131604|NCT01763905|BG002|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
11131605|NCT01763905|BG003|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
11131606|NCT01763905|BG004|Baseline|Total|Total of all reporting groups
11131607|NCT01763905|FG000|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131608|NCT01763905|FG001|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131609|NCT01763905|FG002|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
11131610|NCT01763905|FG003|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
11131611|NCT01763905|OG000|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131612|NCT01763905|OG001|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131613|NCT01763905|OG002|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
11131614|NCT01763905|OG003|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
11131615|NCT01763905|EG000|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131616|NCT01763905|EG001|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
11131617|NCT01763905|EG002|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
11131618|NCT01763905|EG003|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
11131619|NCT01763918|BG000|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
11131620|NCT01763918|BG001|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
11131621|NCT01763918|BG002|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131622|NCT01763918|BG003|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131623|NCT01763918|BG004|Baseline|Total|Total of all reporting groups
11131624|NCT01763918|FG000|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
11131625|NCT01763918|FG001|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
11131626|NCT01763918|FG002|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131627|NCT01763918|FG003|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131628|NCT01763918|OG000|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
11131629|NCT01763918|OG001|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
11131630|NCT01763918|OG002|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131631|NCT01763918|OG003|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131632|NCT01763918|EG000|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
11131633|NCT01763918|EG001|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
11131634|NCT01763918|EG002|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
11131635|NCT01763918|EG003|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
11131636|NCT01763931|BG000|Baseline|Digoxin|"Digoxin administration for 2 weeks prior to surgery.~Digoxin: Digoxin once daily for 2 weeks prior to definitive breast surgery."
11131637|NCT01763931|BG001|Baseline|No Drug Administration Prior to Surgery|Group of participants who will not receive digoxin; however, tissue will be collected at time of definitive breast surgery.
11131638|NCT01763931|BG002|Baseline|Total|Total of all reporting groups
11131639|NCT01763931|FG000|Participant Flow|Digoxin|"Digoxin administration for 2 weeks prior to surgery.~Digoxin: Digoxin once daily for 2 weeks prior to definitive breast surgery."
11131640|NCT01763931|FG001|Participant Flow|No Drug Administration Prior to Surgery|Group of participants who will not receive digoxin; however, tissue will be collected at time of definitive breast surgery.
11131641|NCT01763931|OG000|Outcome|Digoxin|"Digoxin administration for 2 weeks prior to surgery.~Digoxin: Digoxin once daily for 2 weeks prior to definitive breast surgery."
11131642|NCT01763931|OG001|Outcome|No Drug Administration Prior to Surgery|Group of participants who will not receive digoxin; however, tissue will be collected at time of definitive breast surgery.
11131643|NCT01763931|EG000|Reported Event|Digoxin|"Digoxin administration for 2 weeks prior to surgery.~Digoxin: Digoxin once daily for 2 weeks prior to definitive breast surgery."
11131644|NCT01763931|EG001|Reported Event|No Drug Administration Prior to Surgery|Group of participants who will not receive digoxin; however, tissue will be collected at time of definitive breast surgery.
11131645|NCT01763970|BG000|Baseline|Hypofractionated SBRT|"800 delivered in 5 fractions every day to total dose of 4000~SBRT: 800 delivered in 5 fractions every day to total dose of 4000"
11131646|NCT01763970|FG000|Participant Flow|Hypofractionated SBRT|This is a single-arm, prospective trial to examine the efficacy and safety of SBRT (SBRT) for the treatment of bone metastases in pediatric and young adult patients. Patients with metastatic nonrhabdomyosarcoma with bone metastases were treated with SBRT to a total dose of 40 Gy in 5 fractions (8 Gy/fraction). Physicians were permitted to treat up to five distinct lesions per patient.
11131647|NCT01763970|OG000|Outcome|Hypofractionated SBRT|SBRT: 800 centigray (cGy) delivered in 5 fractions every day to total dose of 4000 cGy
11131648|NCT01763970|OG000|Outcome|Hypofractionated SBRT|SBRT: 800 cGy delivered in 5 fractions every day to total dose of 4000 cGy
11131649|NCT01763970|OG000|Outcome|Partial Consolidation|SBRT: 800 cGy delivered in 5 fractions every day to total dose of 4000 cGy. Not all sites of metastatic disease were treated (partial consolidation).
11131650|NCT01763970|OG001|Outcome|Total Consolidation|SBRT: 800 cGy delivered in 5 fractions to a total dose of 4000 cGy. All known sites of metastatic disease were treated.
11131651|NCT01763970|EG000|Reported Event|Hypofractionated SBRT|"800 delivered in 5 fractions every day to total dose of 4000~SBRT: 800 delivered in 5 fractions every day to total dose of 4000"
11131652|NCT01763996|BG000|Baseline|All Participants|All participants who were randomized and received study drug (febuxostat 80 mg and placebo) during the study.
11131653|NCT01763996|FG000|Participant Flow|Sequence 1: Febuxostat 80 mg + Placebo|Febuxostat 80 mg, capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 2.
11131654|NCT01763996|FG001|Participant Flow|Sequence 2: Placebo + Febuxostat 80 mg|Febuxostat placebo-matching capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 2.
11131655|NCT01763996|OG000|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
11131656|NCT01763996|OG001|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
11131657|NCT01763996|EG000|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
11131658|NCT01763996|EG001|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
11131659|NCT01764022|BG000|Baseline|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131660|NCT01764022|BG001|Baseline|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131661|NCT01764022|BG002|Baseline|Total|Total of all reporting groups
11131662|NCT01764022|FG000|Participant Flow|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131663|NCT01764022|FG001|Participant Flow|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131664|NCT01764022|OG000|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131665|NCT01764022|OG001|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131666|NCT01764022|OG000|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131667|NCT01764022|OG001|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131668|NCT01764022|EG000|Reported Event|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131669|NCT01764022|EG001|Reported Event|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
11131670|NCT01764256|BG000|Baseline|10 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 10 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131671|NCT01764256|BG001|Baseline|30 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 30 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131672|NCT01764256|BG002|Baseline|60 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 60 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131673|NCT01764256|BG003|Baseline|Placebo|"3 doses of placebo delivered intramuscularly.~placebo: Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study."
11131674|NCT01764256|BG004|Baseline|Total|Total of all reporting groups
11131675|NCT01764256|FG000|Participant Flow|Placebo|"3 doses of placebo delivered intramuscularly.~placebo: Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study."
11342021|NCT03695094|FG000|Participant Flow|Group 1 (Inducers)|Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 milligrams per day (mg/day), which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
11131676|NCT01764256|FG001|Participant Flow|10 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 10 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131677|NCT01764256|FG002|Participant Flow|30 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 30 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131678|NCT01764256|FG003|Participant Flow|60 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 60 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131679|NCT01764256|OG000|Outcome|10 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 10 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131680|NCT01764256|OG001|Outcome|30 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 30 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131681|NCT01764256|OG002|Outcome|60 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 60 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131682|NCT01764256|OG003|Outcome|Placebo|"3 doses of placebo delivered intramuscularly.~placebo: Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study."
11131683|NCT01764256|OG000|Outcome|Placebo|"3 doses of placebo delivered intramuscularly.~placebo: Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study."
11131684|NCT01764256|OG001|Outcome|10 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 10 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11149571|NCT01871519|EG000|Reported Event|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
11131685|NCT01764256|OG002|Outcome|30 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 30 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131686|NCT01764256|OG003|Outcome|60 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 60 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131687|NCT01764256|EG000|Reported Event|10 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 10 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131688|NCT01764256|EG001|Reported Event|30 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 30 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131689|NCT01764256|EG002|Reported Event|60 μg P2-VP8|"3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 60 μg of active ingredient.~P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration."
11131690|NCT01764256|EG003|Reported Event|Placebo|"3 doses of placebo delivered intramuscularly.~placebo: Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study."
11131691|NCT01764386|BG000|Baseline|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
11131692|NCT01764386|BG001|Baseline|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
11131693|NCT01764386|BG002|Baseline|Total|Total of all reporting groups
11131694|NCT01764386|FG000|Participant Flow|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78)."
11131695|NCT01764386|FG001|Participant Flow|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.~The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78)."
11131696|NCT01764386|OG000|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
11131697|NCT01764386|OG001|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
11131698|NCT01764386|EG000|Reported Event|NB + CLI (Controlled Treatment Period)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~The Controlled Treatment Period was from Day 1 to Week 26."
11131699|NCT01764386|EG001|Reported Event|Usual Care (Controlled Treatment Period)|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.~The Controlled Treatment Period was from Day 1 to Week 26."
11131700|NCT01764386|EG002|Reported Event|All Subjects (Entire Study)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~All Subjects (Entire Study) consisted of all subjects in both the Controlled and Uncontrolled Treatment Periods. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study and subjects assigned to Usual Care were switched to NB+CLI for the duration of the study."
11131701|NCT01764464|BG000|Baseline|Group A|14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
11131702|NCT01764464|BG001|Baseline|Group B|14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).
11131703|NCT01764464|BG002|Baseline|Total|Total of all reporting groups
11131704|NCT01764464|FG000|Participant Flow|Group A (Gralise Then Placebo)|14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
11131705|NCT01764464|FG001|Participant Flow|Group B (Placebo Then Gralise)|14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).
11131706|NCT01764464|OG000|Outcome|Gralise|Gralise
11131707|NCT01764464|OG001|Outcome|Placebo|Placebo
11131708|NCT01764464|EG000|Reported Event|Gralise|
11131709|NCT01764464|EG001|Reported Event|Placebo|
11131710|NCT01764607|BG000|Baseline|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
11131711|NCT01764607|FG000|Participant Flow|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
11131712|NCT01764607|OG000|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
11131713|NCT01764607|EG000|Reported Event|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
11131714|NCT01764633|BG000|Baseline|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
11131715|NCT01764633|BG001|Baseline|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
11131716|NCT01764633|BG002|Baseline|Total|Total of all reporting groups
11131717|NCT01764633|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
11131718|NCT01764633|FG001|Participant Flow|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
11131719|NCT01764633|OG000|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
11131720|NCT01764633|OG001|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
11131721|NCT01764633|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
11131722|NCT01764633|EG001|Reported Event|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
11131723|NCT01764659|BG000|Baseline|GI Group|Study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.
11131724|NCT01764659|FG000|Participant Flow|All Enrolled Patients|Individually optimized CE 4D-CT
11131725|NCT01764659|OG000|Outcome|CE 3DCT|Contrast-enhanced 3DCT
11131726|NCT01764659|OG001|Outcome|4DCT|4DCT without contrast
11131727|NCT01764659|OG002|Outcome|CE 4DCT|Individually optimized contrast-enhanced 4DCT
11131728|NCT01764659|EG000|Reported Event|All Enrolled Patients|One death among enrolled patients, which was not directly related to this research.
11131729|NCT01764685|BG000|Baseline|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 mins) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
11131730|NCT01764685|BG001|Baseline|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
11131731|NCT01764685|BG002|Baseline|Total|Total of all reporting groups
11131732|NCT01764685|FG000|Participant Flow|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 weeks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit~Topiramate: Max therapeutic dose of 150 mg/day~Medical Management: (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
11131733|NCT01764685|FG001|Participant Flow|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
11131734|NCT01764685|OG000|Outcome|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/wk."
11131735|NCT01764685|OG001|Outcome|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
11131736|NCT01764685|EG000|Reported Event|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drink"
11131737|NCT01764685|EG001|Reported Event|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
11131738|NCT01764841|BG000|Baseline|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
11131739|NCT01764841|BG001|Baseline|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11131740|NCT01764841|BG002|Baseline|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
11131741|NCT01764841|BG003|Baseline|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
11131742|NCT01764841|BG004|Baseline|Total|Total of all reporting groups
11131743|NCT01764841|FG000|Participant Flow|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
11131744|NCT01764841|FG001|Participant Flow|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11131745|NCT01764841|FG002|Participant Flow|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
11131746|NCT01764841|FG003|Participant Flow|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
11131747|NCT01764841|OG000|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
11131748|NCT01764841|OG001|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11131749|NCT01764841|OG002|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
11131750|NCT01764841|OG002|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
11131751|NCT01764841|OG003|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
11131752|NCT01764841|EG000|Reported Event|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
11131753|NCT01764841|EG001|Reported Event|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11131754|NCT01764841|EG002|Reported Event|Pooled Placebo|Participants received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
11131755|NCT01764854|BG000|Baseline|AZD1722- in Patient|"Tenapanor administered in a clinical pharmacology unit~AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting"
11131756|NCT01764854|BG001|Baseline|Placebo- in Patient|"Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit~Placebo (in-patient): Placebo, size and color matched to experimental drug administered in a CPU"
11131757|NCT01764854|BG002|Baseline|AZD1722 Out-patient|"Tenapanor~AZD1722 (out-patient): doses between 5 and 45 mg BID"
11131758|NCT01764854|BG003|Baseline|Placebo Out-patient|"Placebo~Placebo: Placebo, size and color matched to experimental drug"
11131759|NCT01764854|BG004|Baseline|Total|Total of all reporting groups
11131760|NCT01764854|FG000|Participant Flow|AZD1722- in Patient|"Tenapanor administered in a clinical pharmacology unit~AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting"
11131761|NCT01764854|FG001|Participant Flow|Placebo- in Patient|Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
11131762|NCT01764854|FG002|Participant Flow|AZD1722 Out-patient|"Tenapanor~AZD1722 (out-patient): doses between 5 and 45 mg BID"
11131763|NCT01764854|FG003|Participant Flow|Placebo Out-patient|"Placebo~Placebo: Placebo, size and color matched to experimental drug"
11131764|NCT01764854|OG000|Outcome|AZD1722 Out-patient|"Tenapanor~AZD1722 (out-patient): doses between 5 and 45 mg BID"
11131765|NCT01764854|OG001|Outcome|Placebo Out-patient|"Placebo~Placebo: Placebo, size and color matched to experimental drug"
11131766|NCT01764854|OG000|Outcome|AZD1722- in Patient|"Tenapanor administered in a clinical pharmacology unit~AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting"
11131767|NCT01764854|OG001|Outcome|Placebo- in Patient|Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
11131768|NCT01764854|EG000|Reported Event|AZD1722- in Patient|"Tenapanor administered in a clinical pharmacology unit~AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting"
11131769|NCT01764854|EG001|Reported Event|Placebo- in Patient|Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
11131770|NCT01764854|EG002|Reported Event|AZD1722 Out-patient|"Tenapanor~AZD1722 (out-patient): doses between 5 and 45 mg BID"
11131771|NCT01764854|EG003|Reported Event|Placebo Out-patient|"Placebo~Placebo: Placebo, size and color matched to experimental drug"
11131772|NCT01764919|BG000|Baseline|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
11131773|NCT01764919|FG000|Participant Flow|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
11131774|NCT01764919|OG000|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
11131775|NCT01764919|EG000|Reported Event|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
11131776|NCT01764945|BG000|Baseline|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131777|NCT01764945|BG001|Baseline|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131778|NCT01764945|BG002|Baseline|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131779|NCT01764945|BG003|Baseline|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131780|NCT01764945|BG004|Baseline|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131781|NCT01764945|BG005|Baseline|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131782|NCT01764945|BG006|Baseline|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131783|NCT01764945|BG007|Baseline|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131784|NCT01764945|BG008|Baseline|Total|Total of all reporting groups
11131785|NCT01764945|FG000|Participant Flow|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131786|NCT01764945|FG001|Participant Flow|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131787|NCT01764945|FG002|Participant Flow|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131788|NCT01764945|FG003|Participant Flow|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131789|NCT01764945|FG004|Participant Flow|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131790|NCT01764945|FG005|Participant Flow|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131791|NCT01764945|FG006|Participant Flow|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131792|NCT01764945|FG007|Participant Flow|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
11131793|NCT01764945|OG000|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
11131794|NCT01764945|OG001|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
11131795|NCT01764945|OG002|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
11131796|NCT01764945|OG003|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
11131797|NCT01764945|OG004|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
11131798|NCT01764945|OG005|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
11131799|NCT01764945|OG006|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
11131800|NCT01764945|OG007|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
11131801|NCT01764945|EG000|Reported Event|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
11131802|NCT01764945|EG001|Reported Event|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1.
11131803|NCT01764945|EG002|Reported Event|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2.
11131804|NCT01764945|EG003|Reported Event|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3.
11131805|NCT01764945|EG004|Reported Event|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
11131806|NCT01764945|EG005|Reported Event|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1.
11131807|NCT01764945|EG006|Reported Event|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2.
11131808|NCT01764945|EG007|Reported Event|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3.
11131809|NCT01765153|BG000|Baseline|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
11131810|NCT01765153|BG001|Baseline|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
11131811|NCT01765153|BG002|Baseline|Total|Total of all reporting groups
11131812|NCT01765153|FG000|Participant Flow|Endurance First|Participants start with Endurance Training. Participants trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Precision Training 5x/wk for 2 months. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
11131813|NCT01765153|FG001|Participant Flow|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training, which is followed by another 2-month rest.
11131814|NCT01765153|OG000|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
11131815|NCT01765153|OG001|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
11131816|NCT01765153|OG000|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Trainingis 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
11131817|NCT01765153|OG000|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
11131818|NCT01765153|OG001|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
11131819|NCT01765153|OG001|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
11131820|NCT01765153|EG000|Reported Event|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
11131821|NCT01765153|EG001|Reported Event|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
11131822|NCT01765179|BG000|Baseline|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
11131823|NCT01765179|FG000|Participant Flow|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
11131824|NCT01765179|OG000|Outcome|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
11131825|NCT01765179|EG000|Reported Event|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
11131826|NCT01765192|BG000|Baseline|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
11131827|NCT01765192|BG001|Baseline|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
11131828|NCT01765192|BG002|Baseline|Total|Total of all reporting groups
11131829|NCT01765192|FG000|Participant Flow|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
11131830|NCT01765192|FG001|Participant Flow|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
11131831|NCT01765192|OG000|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
11131832|NCT01765192|OG001|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
11131833|NCT01765192|EG000|Reported Event|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
11131834|NCT01765192|EG001|Reported Event|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
11131835|NCT01765270|BG000|Baseline|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
11131836|NCT01765270|BG001|Baseline|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
11131837|NCT01765270|BG002|Baseline|Total|Total of all reporting groups
11131838|NCT01765270|FG000|Participant Flow|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
11131839|NCT01765270|FG001|Participant Flow|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
11131840|NCT01765270|OG000|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
11131841|NCT01765270|OG001|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
11131842|NCT01765270|OG000|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.daily
11131843|NCT01765270|EG000|Reported Event|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
11131844|NCT01765270|EG001|Reported Event|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
11131845|NCT01765426|BG000|Baseline|Group 1: TDV Using PharmaJet® Injector|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131846|NCT01765426|BG001|Baseline|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131847|NCT01765426|BG002|Baseline|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
11131848|NCT01765426|BG003|Baseline|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131849|NCT01765426|BG004|Baseline|Total|Total of all reporting groups
11131850|NCT01765426|FG000|Participant Flow|Group 1: TDV Using PharmaJet® Injector|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131851|NCT01765426|FG001|Participant Flow|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131852|NCT01765426|FG002|Participant Flow|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
11131853|NCT01765426|FG003|Participant Flow|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131854|NCT01765426|OG000|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131855|NCT01765426|OG001|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131856|NCT01765426|OG002|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
11131857|NCT01765426|OG003|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131858|NCT01765426|EG000|Reported Event|Group 1: TDV Using PharmaJet® Injector|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131859|NCT01765426|EG001|Reported Event|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131860|NCT01765426|EG002|Reported Event|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
11131861|NCT01765426|EG003|Reported Event|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
11131862|NCT01765465|BG000|Baseline|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
10849030|NCT00293267|EG001|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
11131863|NCT01765465|BG001|Baseline|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
11131864|NCT01765465|BG002|Baseline|Total|Total of all reporting groups
11131865|NCT01765465|FG000|Participant Flow|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
11131866|NCT01765465|FG001|Participant Flow|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
11131867|NCT01765465|OG000|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
11131868|NCT01765465|OG001|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
11131869|NCT01765465|OG000|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
11131870|NCT01765465|OG001|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
11131871|NCT01765465|EG000|Reported Event|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
11131872|NCT01765465|EG001|Reported Event|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
11131873|NCT01765530|BG000|Baseline|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
11131874|NCT01765530|BG001|Baseline|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
11131875|NCT01765530|BG002|Baseline|Total|Total of all reporting groups
11131876|NCT01765530|FG000|Participant Flow|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
11131877|NCT01765530|FG001|Participant Flow|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
11131878|NCT01765530|OG000|Outcome|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
11131879|NCT01765530|OG001|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
11131880|NCT01765530|EG000|Reported Event|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
11131881|NCT01765530|EG001|Reported Event|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
11131882|NCT01765543|BG000|Baseline|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
11131883|NCT01765543|FG000|Participant Flow|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib (Zelboraf) at a dose of 960 milligrams (mg) as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
11131884|NCT01765543|OG000|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
11131885|NCT01765543|OG001|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
11131886|NCT01765543|EG000|Reported Event|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
11131887|NCT01765543|EG001|Reported Event|Rifampin (Intervention Period B)|Participants received rifampin alone at a dose of 600 mg as capsules orally once daily from Days 8 through 16.
11131888|NCT01765543|EG002|Reported Event|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
11131889|NCT01765543|EG003|Reported Event|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
11131890|NCT01765569|BG000|Baseline|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.~Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.~Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
11131891|NCT01765569|FG000|Participant Flow|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.~Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.~Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
11131892|NCT01765569|OG000|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
11131893|NCT01765569|OG001|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
11131894|NCT01765569|EG000|Reported Event|Period A|Single oral dose of digoxin 0.25 mg tablet on Day 1.
11131895|NCT01765569|EG001|Reported Event|Period B|Vemurafenib 960 mg orally BID from Day 8 to Day 28.
11131896|NCT01765569|EG002|Reported Event|Period C|Single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35.
11149572|NCT01871532|BG000|Baseline|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
11131897|NCT01765582|BG000|Baseline|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131898|NCT01765582|BG001|Baseline|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131899|NCT01765582|BG002|Baseline|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131900|NCT01765582|BG003|Baseline|Total|Total of all reporting groups
11131901|NCT01765582|FG000|Participant Flow|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131902|NCT01765582|FG001|Participant Flow|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131903|NCT01765582|FG002|Participant Flow|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131904|NCT01765582|OG000|Outcome|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131905|NCT01765582|OG001|Outcome|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131906|NCT01765582|OG002|Outcome|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131907|NCT01765582|OG003|Outcome|Arms A + B: Pooled FOLFOXIRI + Bevacizumab|This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
10849031|NCT00293293|BG000|Baseline|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
11131908|NCT01765582|EG000|Reported Event|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131909|NCT01765582|EG001|Reported Event|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131910|NCT01765582|EG002|Reported Event|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
11131911|NCT01765647|BG000|Baseline|AGY: Anti-gliadin Antibody for Celiac Disease|"All participants will receive the same, open-label dose of AGY~AGY: AGY is a natural health product produced in egg yolks"
11131912|NCT01765647|FG000|Participant Flow|AGY: Anti-gliadin Antibody for Celiac Disease|"All participants will receive the same, open-label dose of AGY~AGY: AGY is a natural health product produced in egg yolks"
11131913|NCT01765647|OG000|Outcome|AGY: Anti-gliadin Antibody for Celiac Disease|"All participants will receive the same, open-label dose of AGY~AGY: AGY is a natural health product produced in egg yolks"
11131914|NCT01765647|EG000|Reported Event|AGY: Anti-gliadin Antibody for Celiac Disease|"All participants will receive the same, open-label dose of AGY~AGY: AGY is a natural health product produced in egg yolks"
11131915|NCT01765673|BG000|Baseline|Vibrotactile Stimulation in Dysphagia|"A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort~Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions."
11131916|NCT01765673|FG000|Participant Flow|Vibrotactile Stimulation in Dysphagia|"A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort~Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions."
11131917|NCT01765673|OG000|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
11131918|NCT01765673|OG000|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
11131919|NCT01765673|OG000|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will also compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of swallow initiation. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
11131920|NCT01765673|OG000|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and swallow initiation time during vibration with no vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
11131921|NCT01765673|EG000|Reported Event|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
11131922|NCT01765712|BG000|Baseline|PRP Treatment|27 patients received the PRP treatment
11131923|NCT01765712|BG001|Baseline|Sham Treatment|23 patients received the sham treatment
11131924|NCT01765712|BG002|Baseline|Total|Total of all reporting groups
11131925|NCT01765712|FG000|Participant Flow|PRP Treatment|Patients treated with PRP
11131926|NCT01765712|FG001|Participant Flow|Sham|Patients not receiving PRP
11131927|NCT01765712|OG000|Outcome|PRP Treatment|Patients treated with PRP
11131928|NCT01765712|OG001|Outcome|Sham|Patients not receiving PRP
11131929|NCT01765712|EG000|Reported Event|PRP Treatment|Patients treated with PRP
11131930|NCT01765712|EG001|Reported Event|Sham|Patients not receiving PRP
11131931|NCT01765751|BG000|Baseline|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131932|NCT01765751|BG001|Baseline|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131933|NCT01765751|BG002|Baseline|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131934|NCT01765751|BG003|Baseline|Total|Total of all reporting groups
11131935|NCT01765751|FG000|Participant Flow|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131936|NCT01765751|FG001|Participant Flow|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131937|NCT01765751|FG002|Participant Flow|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131938|NCT01765751|OG000|Outcome|MCD Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131939|NCT01765751|OG001|Outcome|MCD Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131940|NCT01765751|OG002|Outcome|MCD High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131941|NCT01765751|OG000|Outcome|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131942|NCT01765751|OG001|Outcome|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131943|NCT01765751|OG002|Outcome|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131944|NCT01765751|EG000|Reported Event|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131945|NCT01765751|EG001|Reported Event|Manual Cervical Distraction Medium Force*|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131946|NCT01765751|EG002|Reported Event|Manual Cervical Distraction High Force*|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
11131947|NCT01765764|BG000|Baseline|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
11131948|NCT01765764|BG001|Baseline|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
11131949|NCT01765764|BG002|Baseline|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
11131950|NCT01765764|BG003|Baseline|Total|Total of all reporting groups
11131951|NCT01765764|FG000|Participant Flow|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
11131952|NCT01765764|FG001|Participant Flow|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
11131953|NCT01765764|FG002|Participant Flow|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
11131954|NCT01765764|OG000|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
11131955|NCT01765764|OG001|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
11131956|NCT01765764|OG002|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
11131957|NCT01765764|EG000|Reported Event|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
11131958|NCT01765764|EG001|Reported Event|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
11131959|NCT01765764|EG002|Reported Event|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
11131960|NCT01765803|BG000|Baseline|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
11131961|NCT01765803|FG000|Participant Flow|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
11131962|NCT01765803|OG000|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
11131963|NCT01765803|EG000|Reported Event|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
11131964|NCT01765920|BG000|Baseline|Ergoferon (5 ml 3 Times a Day)|"Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.~Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.~Ergoferon: 5 ml 3 times a day"
11131965|NCT01765920|BG001|Baseline|Placebo (5 ml 3 Times a Day)|"Oral use. Placebo using Ergoferon scheme.~Placebo: 5 ml 3 times a day"
11131966|NCT01765920|BG002|Baseline|Total|Total of all reporting groups
11131967|NCT01765920|FG000|Participant Flow|Ergoferon (5 ml 3 Times a Day)|"Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.~Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.~Ergoferon: 5 ml 3 times a day"
11131968|NCT01765920|FG001|Participant Flow|Placebo (5 ml 3 Times a Day)|"Oral use. Placebo using Ergoferon scheme.~Placebo: 5 ml 3 times a day"
11131969|NCT01765920|OG000|Outcome|Ergoferon (5 ml 3 Times a Day)|"Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.~Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.~Ergoferon: 5 ml 3 times a day"
11131970|NCT01765920|OG001|Outcome|Placebo (5 ml 3 Times a Day)|"Oral use. Placebo using Ergoferon scheme.~Placebo: 5 ml 3 times a day"
11131971|NCT01765920|EG000|Reported Event|Ergoferon (5 ml 3 Times a Day)|"Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.~Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.~Ergoferon: 5 ml 3 times a day"
11131972|NCT01765920|EG001|Reported Event|Placebo (5 ml 3 Times a Day)|"Oral use. Placebo using Ergoferon scheme.~Placebo: 5 ml 3 times a day"
11131973|NCT01765972|BG000|Baseline|Overall|All subjects that were dispensed a study lens.
11131974|NCT01765972|FG000|Participant Flow|Test 1/Spectacle/Test 2/ Test 3|Subjects received Test 1 (etafilcon A with Laceron) and then received spectacle and then received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print).
11131975|NCT01765972|FG001|Participant Flow|Test 2/ Test 3/ Spectacle/ Test 1|Subjects received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print) and then received spectacle and then received Test 1 (etafilcon A with Laceron).
11131976|NCT01765972|FG002|Participant Flow|Test 3/ Test 1/ Test 2/ Spectacle|Subjects received Test 3 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 2 (etafilcon A with print) and then received spectacle.
11131977|NCT01765972|FG003|Participant Flow|Spectacle/ Test 2/ Test 1/ Test 3|Subjects received spectacle and then received Test 2 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 3 (etafilcon A with print) .
11131978|NCT01765972|OG000|Outcome|Test 1 (Etafilcon A With Lacreon)|Subjects that received Test 1 (etafilcon A with Lacreon) lens in any of the 4 periods of this study.
11131979|NCT01765972|OG001|Outcome|Test 2 (Etafilcon A With Lacreon With Print)|Subjects that received Test 2 (etafilcon A with Lacreon with print) lens in any of the 4 periods of this study.
11131980|NCT01765972|OG002|Outcome|Test 3 (Etafilcon A With Print)|Subjects that received Test 3 (etafilcon A with print) lens in any of the 4 periods of this study.
11131981|NCT01765972|OG003|Outcome|Spectacle|Subjects that wore spectacles in any of the 4 periods of this study.
11131982|NCT01765972|EG000|Reported Event|Spectacle|Subjects wore spectacles in any of the 4 periods of this study.
11131983|NCT01765972|EG001|Reported Event|Test 1 (Etafilcon A With Lacreon)|Subjects received Test 1 (etafilcon A with Lacreon) in any of the 4 periods of this study.
11131984|NCT01765972|EG002|Reported Event|Test 2 (Etafilcon A With Lacreon With Print)|Subjects received Test 2 (etafilcon A with Lacreon with print) in any of the 4 periods of this study.
11131985|NCT01765972|EG003|Reported Event|Test 3 (Etafilcon A With Print)|Subjects received Test 3 (etafilcon A with print) in any of the 4 periods of this study.
11131986|NCT01766024|BG000|Baseline|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
11131987|NCT01766024|BG001|Baseline|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
11131988|NCT01766024|BG002|Baseline|Total|Total of all reporting groups
11131989|NCT01766024|FG000|Participant Flow|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
11131990|NCT01766024|FG001|Participant Flow|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
11131991|NCT01766024|OG000|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
11131992|NCT01766024|OG001|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
11131993|NCT01766024|OG000|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033 (interferon beta-1a)
11131994|NCT01766024|OG001|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif (interferon beta-1a) a
11131995|NCT01766024|EG000|Reported Event|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
11131996|NCT01766024|EG001|Reported Event|Rebif|the endpoint was assessed in all the volunteer who received Rebif
11131997|NCT01766037|BG000|Baseline|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
11131998|NCT01766037|BG001|Baseline|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
11131999|NCT01766037|BG002|Baseline|Total|Total of all reporting groups
11132000|NCT01766037|FG000|Participant Flow|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
11132001|NCT01766037|FG001|Participant Flow|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
11132002|NCT01766037|OG000|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
11132003|NCT01766037|OG001|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
11132004|NCT01766037|EG000|Reported Event|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
11132005|NCT01766037|EG001|Reported Event|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
11132006|NCT01766050|BG000|Baseline|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
11132007|NCT01766050|FG000|Participant Flow|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
11132008|NCT01766050|OG000|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
11132009|NCT01766050|OG001|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
11132010|NCT01766050|OG002|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
11132011|NCT01766050|OG003|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
11132012|NCT01766050|OG001|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
11132013|NCT01766050|OG001|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
11132014|NCT01766050|OG001|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
11132015|NCT01766050|OG003|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1, 4, 7 and 11.
11132016|NCT01766050|OG000|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 1.
10849032|NCT00293293|BG001|Baseline|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
10849033|NCT00293293|BG002|Baseline|Total|Total of all reporting groups
11132017|NCT01766050|OG003|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day11.
11132018|NCT01766050|OG000|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day1.
11132019|NCT01766050|OG001|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered on Day 4.
11132020|NCT01766050|OG004|Outcome|All Participants|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
11132021|NCT01766050|OG000|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
11132022|NCT01766050|OG000|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
11132023|NCT01766050|EG000|Reported Event|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
11149573|NCT01871532|BG001|Baseline|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
11149574|NCT01871532|BG002|Baseline|Total|Total of all reporting groups
11149575|NCT01871532|FG000|Participant Flow|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
11149576|NCT01871532|FG001|Participant Flow|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
11132024|NCT01766076|BG000|Baseline|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC will be collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
11132025|NCT01766076|BG001|Baseline|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
11132026|NCT01766076|BG002|Baseline|Total|Total of all reporting groups
11132027|NCT01766076|FG000|Participant Flow|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC collected for immune activation assays using flowcytometry"
11132028|NCT01766076|FG001|Participant Flow|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC were collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
11132029|NCT01766076|OG000|Outcome|Atorvastatin|"Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
11132030|NCT01766076|OG001|Outcome|Placebo|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
11132031|NCT01766076|EG000|Reported Event|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMCwere collected for immune activation assays using flowcytometry"
11132032|NCT01766076|EG001|Reported Event|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC wiere collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
11132033|NCT01766102|BG000|Baseline|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
11132034|NCT01766102|BG001|Baseline|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
10879654|NCT00459186|BG000|Baseline|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
11132035|NCT01766102|BG002|Baseline|Total|Total of all reporting groups
11132036|NCT01766102|FG000|Participant Flow|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
11132037|NCT01766102|FG001|Participant Flow|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
11132038|NCT01766102|OG000|Outcome|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
11132039|NCT01766102|OG001|Outcome|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
11132040|NCT01766102|EG000|Reported Event|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
11132041|NCT01766102|EG001|Reported Event|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
11132042|NCT01766206|BG000|Baseline|MenACWY-CRM Group|Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
11132043|NCT01766206|FG000|Participant Flow|MenACWY-CRM Group|Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
10879655|NCT00459186|FG000|Participant Flow|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
11132044|NCT01766206|OG000|Outcome|MenACWY-CRM Group|Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
11132045|NCT01766206|EG000|Reported Event|MenACWY-CRM Group|Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
11132046|NCT01766219|BG000|Baseline|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m²|"Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132047|NCT01766219|BG001|Baseline|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132048|NCT01766219|BG002|Baseline|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132049|NCT01766219|BG003|Baseline|Total|Total of all reporting groups
11132050|NCT01766219|FG000|Participant Flow|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m²|"Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132051|NCT01766219|FG001|Participant Flow|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132052|NCT01766219|FG002|Participant Flow|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment."
11132053|NCT01766219|OG000|Outcome|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m²|"Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132054|NCT01766219|OG001|Outcome|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132055|NCT01766219|OG002|Outcome|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132056|NCT01766219|OG000|Outcome|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132057|NCT01766219|EG000|Reported Event|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m²|"Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132058|NCT01766219|EG001|Reported Event|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
10849034|NCT00293293|FG000|Participant Flow|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
11132059|NCT01766219|EG002|Reported Event|Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m²|"Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.~Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.~6,8-bis(benzylthio)octanoic acid: Given IV"
11132060|NCT01766310|BG000|Baseline|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
11132061|NCT01766310|BG001|Baseline|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
11132062|NCT01766310|BG002|Baseline|Total|Total of all reporting groups
11132063|NCT01766310|FG000|Participant Flow|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
11132064|NCT01766310|FG001|Participant Flow|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
11132065|NCT01766310|OG000|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
11132066|NCT01766310|OG001|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
11132067|NCT01766310|EG000|Reported Event|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
11132068|NCT01766310|EG001|Reported Event|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
11132069|NCT01766336|BG000|Baseline|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
11132070|NCT01766336|BG001|Baseline|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
11132071|NCT01766336|BG002|Baseline|Total|Total of all reporting groups
11132072|NCT01766336|FG000|Participant Flow|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
11132073|NCT01766336|FG001|Participant Flow|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
11132074|NCT01766336|OG000|Outcome|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
11132075|NCT01766336|OG001|Outcome|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
11132076|NCT01766336|EG000|Reported Event|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
11132077|NCT01766336|EG001|Reported Event|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
11132078|NCT01766401|BG000|Baseline|Placebo|Dose-matched placebo tablets, oral administration, once per day
11132079|NCT01766401|BG001|Baseline|Vilazadone|Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
11132080|NCT01766401|BG002|Baseline|Total|Total of all reporting groups
11132081|NCT01766401|FG000|Participant Flow|Placebo|Dose-matched placebo tablets, oral administration, once per day
11132082|NCT01766401|FG001|Participant Flow|Vilazadone|Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
11132083|NCT01766401|OG000|Outcome|Placebo|Dose-matched placebo tablets, oral administration, once per day
11132084|NCT01766401|OG001|Outcome|Vilazadone|Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
11132085|NCT01766401|EG000|Reported Event|Placebo|Dose-matched placebo tablets, oral administration, once per day
11132086|NCT01766401|EG001|Reported Event|Vilazadone|Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
11132087|NCT01766440|BG000|Baseline|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
11132088|NCT01766440|FG000|Participant Flow|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
11132089|NCT01766440|OG000|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
11132090|NCT01766440|EG000|Reported Event|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
11132091|NCT01766466|BG000|Baseline|ITT Population - Ticagrelor 6 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses.~On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 24 hours prior."
11132092|NCT01766466|BG001|Baseline|ITT Population - Ticagrelor 7 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses.~On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 12 hours prior."
11132093|NCT01766466|BG002|Baseline|Total|Total of all reporting groups
11132094|NCT01766466|FG000|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 0.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 0.5h after the initiation of the cangrelor infusion.
11132095|NCT01766466|FG001|Participant Flow|Day 5 - Ticagrelor (90 mg) Dosing (6 Doses)|Ticagrelor (90mg) discontinued 24h prior to the initiation of a 2h cangrelor infusion.
11132096|NCT01766466|FG002|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 1.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 1.5h after the initiation of the cangrelor infusion.
11132097|NCT01766466|FG003|Participant Flow|Day 5 - Ticagrelor (90mg) Dosing (7 Doses)|Ticagrelor (90mg) discontinued 12h prior to the initiation of a 2h cangrelor infusion.
11132098|NCT01766466|OG000|Outcome|All Patients|
11132099|NCT01766466|OG001|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
11132100|NCT01766466|OG002|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
11132101|NCT01766466|OG001|Outcome|Ticagrelor Discontinued 24 h Prior to Cangrelor Infusion|
11132102|NCT01766466|OG002|Outcome|Ticagrelor Discontinued 12 h Prior to Cangrelor Infusion|
11132103|NCT01766466|EG000|Reported Event|Cangrelor + Ticagrelor 90mg (6 Doses)|Ticagrelor was discontinued 24 h prior to cangrelor infusion
11132104|NCT01766466|EG001|Reported Event|Cangrelor + Ticagrelor 90mg (7 Doses)|Ticagrelor discontinued 12 h prior to cangrelor infusion
11132105|NCT01766713|BG000|Baseline|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
11132106|NCT01766713|BG001|Baseline|Placebo|Placebo only
11132107|NCT01766713|BG002|Baseline|Total|Total of all reporting groups
11132108|NCT01766713|FG000|Participant Flow|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
11132109|NCT01766713|FG001|Participant Flow|Placebo|Placebo identical to ezetimibe
11132110|NCT01766713|OG000|Outcome|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
11132111|NCT01766713|OG001|Outcome|Placebo|Placebo identical to ezetimibe
11132112|NCT01766713|EG000|Reported Event|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
11132113|NCT01766713|EG001|Reported Event|Placebo|Placebo identical to 10 mg/day of Ezetimibe
11132114|NCT01766778|BG000|Baseline|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
11132115|NCT01766778|BG001|Baseline|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
11132116|NCT01766778|BG002|Baseline|Total|Total of all reporting groups
11132117|NCT01766778|FG000|Participant Flow|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
11132118|NCT01766778|FG001|Participant Flow|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
11132119|NCT01766778|OG000|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
11132120|NCT01766778|OG001|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
11132121|NCT01766778|EG000|Reported Event|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
11132122|NCT01766778|EG001|Reported Event|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
11132123|NCT01766817|BG000|Baseline|BMS-986020 600 mg Once Daily|Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg*2) once daily (QD), for 26 weeks.
11132124|NCT01766817|BG001|Baseline|BMS-986020 600 mg Twice Daily|Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg*2) twice daily (BID), for 26 weeks.
11132125|NCT01766817|BG002|Baseline|Placebo|Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
11132126|NCT01766817|BG003|Baseline|Total|Total of all reporting groups
11132127|NCT01766817|FG000|Participant Flow|BMS-986020 600 mg Once Daily|Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg*2) once daily (QD), for 26 weeks.
11132128|NCT01766817|FG001|Participant Flow|BMS-986020 600 mg Twice Daily|Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg*2) twice daily (BID), for 26 weeks.
11132129|NCT01766817|FG002|Participant Flow|Placebo|Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
11132130|NCT01766817|OG000|Outcome|BMS-986020 600 mg Once Daily|Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg*2) once daily (QD), for 26 weeks.
11132131|NCT01766817|OG001|Outcome|BMS-986020 600 mg Twice Daily|Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg*2) twice daily (BID), for 26 weeks.
11132132|NCT01766817|OG002|Outcome|Placebo|Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
11132133|NCT01766817|EG000|Reported Event|BMS-986020 600 mg Once Daily|Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg*2) once daily (QD), for 26 weeks.
11132134|NCT01766817|EG001|Reported Event|BMS-986020 600 mg Twice Daily|Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg*2) twice daily (BID), for 26 weeks.
11132135|NCT01766817|EG002|Reported Event|Placebo|Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
11132136|NCT01766921|BG000|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11132137|NCT01766921|BG001|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11132138|NCT01766921|BG002|Baseline|Total|Total of all reporting groups
11132139|NCT01766921|FG000|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11132140|NCT01766921|FG001|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11132141|NCT01766921|OG000|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11132142|NCT01766921|OG001|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11132143|NCT01766921|EG000|Reported Event|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
11132144|NCT01766921|EG001|Reported Event|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 three weeks apart.
11132145|NCT01766921|EG002|Reported Event|Total|Total of subjects in both high and low dose groups.
11132146|NCT01766986|BG000|Baseline|Group 1|Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the ﬁnal histological report conﬁrmed an AOG type I
11132147|NCT01766986|BG001|Baseline|Group 2|Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the ﬁnal histology showed AOG type II
11132148|NCT01766986|BG002|Baseline|Group 3|Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy
11132149|NCT01766986|BG003|Baseline|Total|Total of all reporting groups
11132150|NCT01766986|FG000|Participant Flow|Group 1|Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the ﬁnal histological report conﬁrmed an AOG type I
11132151|NCT01766986|FG001|Participant Flow|Group 2|Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the ﬁnal histology showed AOG type II
11132152|NCT01766986|FG002|Participant Flow|Group 3|Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy
11132153|NCT01766986|OG000|Outcome|Group 1|Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the ﬁnal histological report conﬁrmed an AOG type I
11132154|NCT01766986|OG001|Outcome|Group 2|Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the ﬁnal histology showed AOG type II
11132155|NCT01766986|OG002|Outcome|Group 3|Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy
11132156|NCT01766986|EG000|Reported Event|Group 1|Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the ﬁnal histological report conﬁrmed an AOG type I
11132157|NCT01766986|EG001|Reported Event|Group 2|Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the ﬁnal histology showed AOG type II
11132158|NCT01766986|EG002|Reported Event|Group 3|Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy
11132159|NCT01767064|BG000|Baseline|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.~Posted commitment letter"
11132160|NCT01767064|BG001|Baseline|Control|Usual care with no posted letters.
11132161|NCT01767064|BG002|Baseline|Total|Total of all reporting groups
11132162|NCT01767064|FG000|Participant Flow|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.~Posted commitment letter"
11132163|NCT01767064|FG001|Participant Flow|Control|Usual care with no posted letters.
11132164|NCT01767064|OG000|Outcome|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.~Posted commitment letter"
11132165|NCT01767064|OG001|Outcome|Control|Usual care with no posted letters.
11132166|NCT01767064|EG000|Reported Event|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.~Posted commitment letter"
11132167|NCT01767064|EG001|Reported Event|Control|Usual care with no posted letters.
11132168|NCT01767103|BG000|Baseline|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
11132169|NCT01767103|BG001|Baseline|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
11132170|NCT01767103|BG002|Baseline|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
11132171|NCT01767103|BG003|Baseline|Total|Total of all reporting groups
11132172|NCT01767103|FG000|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function. All subjects received a single 33 mg/kg oral dose of deferiprone.
11132173|NCT01767103|FG001|Participant Flow|Mild Hepatic Failure|Mild hepatic impairment as defined by Child-Pugh Class C: 5-6 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
11132174|NCT01767103|FG002|Participant Flow|Moderate Hepatic Failure|Moderate hepatic impairment as defined by Child-Pugh Class : 7-9 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
11132175|NCT01767103|OG000|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
11132176|NCT01767103|OG001|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
11132177|NCT01767103|OG002|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
11132178|NCT01767103|OG002|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
11132179|NCT01767103|EG000|Reported Event|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
11132180|NCT01767103|EG001|Reported Event|Mild Hepatic Failure|Mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points
11132181|NCT01767103|EG002|Reported Event|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
11132182|NCT01767116|BG000|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11132183|NCT01767116|BG001|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
11132184|NCT01767116|BG002|Baseline|Total|Total of all reporting groups
11132185|NCT01767116|FG000|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11132186|NCT01767116|FG001|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
11132187|NCT01767116|OG000|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11132188|NCT01767116|OG001|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
11132189|NCT01767116|EG000|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11132190|NCT01767116|EG001|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
11132191|NCT01767142|BG000|Baseline|Fat Reduction of the Lateral Thigh|"Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. Treatment will be applied to one (1) outer thigh.~The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration."
11132192|NCT01767142|FG000|Participant Flow|Lateral Thigh Treatment Group|Treatment with the CoolSculpting System and a modified belt applicator will be performed. Non-invasive cooling is applied to one outer thigh with a protocol-defined cooling rate and duration of 120 minutes. Only one cooling cycle will be performed per subject.
11132193|NCT01767142|OG000|Outcome|Fat Reduction of the Lateral Thigh|"Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.~The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration."
11132194|NCT01767142|EG000|Reported Event|Fat Reduction of the Lateral Thigh|"Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.~The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration."
11132195|NCT01767155|BG000|Baseline|AEZS-108 / Zoptarelin Doxorubicin|"267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles~AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles"
11132196|NCT01767155|BG001|Baseline|Doxorubicin/ Standard Chemotherapy|"60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles~doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles"
11132197|NCT01767155|BG002|Baseline|Total|Total of all reporting groups
11132198|NCT01767155|FG000|Participant Flow|AEZS-108 / Zoptarelin Doxorubicin|"267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles~AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles"
11132199|NCT01767155|FG001|Participant Flow|Doxorubicin/ Standard Chemotherapy|"60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles~doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles"
11132200|NCT01767155|OG000|Outcome|AEZS-108 / Zoptarelin Doxorubicin|"267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles~AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles"
11132201|NCT01767155|OG001|Outcome|Doxorubicin/ Standard Chemotherapy|"60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles~doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles"
11132202|NCT01767155|EG000|Reported Event|AEZS-108 / Zoptarelin Doxorubicin|"267 mg/m^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles~AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles"
11132203|NCT01767155|EG001|Reported Event|Doxorubicin/ Standard Chemotherapy|"60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles~doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles"
11132204|NCT01767285|BG000|Baseline|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
11132205|NCT01767285|BG001|Baseline|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
11132206|NCT01767285|BG002|Baseline|Total|Total of all reporting groups
11132207|NCT01767285|FG000|Participant Flow|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
11132208|NCT01767285|FG001|Participant Flow|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
11132209|NCT01767285|OG000|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
11132210|NCT01767285|OG001|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
11132211|NCT01767285|EG000|Reported Event|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
11132212|NCT01767285|EG001|Reported Event|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
11132213|NCT01767376|BG000|Baseline|Nimenrix+ Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
11132214|NCT01767376|BG001|Baseline|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132215|NCT01767376|BG002|Baseline|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132216|NCT01767376|BG003|Baseline|Total|Total of all reporting groups
11132217|NCT01767376|FG000|Participant Flow|Nimenrix+ Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
11132218|NCT01767376|FG001|Participant Flow|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132219|NCT01767376|FG002|Participant Flow|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132220|NCT01767376|OG000|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
11132221|NCT01767376|OG001|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132222|NCT01767376|OG002|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132223|NCT01767376|OG001|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132224|NCT01767376|OG000|Outcome|Nimenri+ Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
11132225|NCT01767376|EG000|Reported Event|Nimenrix+ Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
11132226|NCT01767376|EG001|Reported Event|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132227|NCT01767376|EG002|Reported Event|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
11132228|NCT01767415|BG000|Baseline|Indigo Carmine|"Intraoperative stereotactic injection of Indigo Carmine~Indigo carmine: During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection."
11132229|NCT01767415|FG000|Participant Flow|Indigo Carmine|"Intraoperative stereotactic injection of Indigo Carmine~Indigo carmine: During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection."
11132230|NCT01767415|OG000|Outcome|Indigo Carmine|"Intraoperative stereotactic injection of Indigo Carmine~Indigo carmine: During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection."
11132231|NCT01767415|EG000|Reported Event|Indigo Carmine|"Intraoperative stereotactic injection of Indigo Carmine~Indigo carmine: During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection."
11132232|NCT01767467|BG000|Baseline|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
11132233|NCT01767467|BG001|Baseline|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
11132234|NCT01767467|BG002|Baseline|Total|Total of all reporting groups
11132235|NCT01767467|FG000|Participant Flow|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
11132236|NCT01767467|FG001|Participant Flow|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
11132237|NCT01767467|OG000|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
11132238|NCT01767467|OG001|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
11132239|NCT01767467|OG000|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose)
11132240|NCT01767467|OG001|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose)
11132241|NCT01767467|OG001|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
11132242|NCT01767467|OG000|Outcome|GSK1437173A HZ Cases Sub-Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
11132243|NCT01767467|OG001|Outcome|GSK1437173A Non-HZ Cases Sub-Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
11132244|NCT01767467|OG002|Outcome|Placebo HZ Cases Sub-Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
11132245|NCT01767467|OG003|Outcome|Placebo Non-HZ Cases Sub-Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
11132246|NCT01767467|EG000|Reported Event|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
11132247|NCT01767467|EG001|Reported Event|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
11132248|NCT01767493|BG000|Baseline|[18F]Florbetapir PET Imaging|[18F]Florbetapir and PET imaging
11132249|NCT01767493|FG000|Participant Flow|[18F]Florbetapir Imaging|[18F]Florbetapir and PET imaging
11132250|NCT01767493|OG000|Outcome|[18F]Florbetapir PET Imaging|[18F]Florbetapir and PET imaging
11132251|NCT01767493|EG000|Reported Event|[18F]Florbetapir PET Imaging|[18F]Florbetapir and PET imaging
11132252|NCT01767506|BG000|Baseline|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
11132253|NCT01767506|BG001|Baseline|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
11132254|NCT01767506|BG002|Baseline|Total|Total of all reporting groups
11132255|NCT01767506|FG000|Participant Flow|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or Follicular Trachoma (TF) is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled MDA of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
11132256|NCT01767506|FG001|Participant Flow|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
11149577|NCT01871532|OG000|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
11132257|NCT01767506|OG000|Outcome|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
11132258|NCT01767506|OG001|Outcome|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
11132259|NCT01767506|EG000|Reported Event|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
11132260|NCT01767506|EG001|Reported Event|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
11132261|NCT01767519|BG000|Baseline|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
11132262|NCT01767519|BG001|Baseline|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
11132263|NCT01767519|BG002|Baseline|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
11132264|NCT01767519|BG003|Baseline|Total|Total of all reporting groups
11132265|NCT01767519|FG000|Participant Flow|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
11132266|NCT01767519|FG001|Participant Flow|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
11132267|NCT01767519|FG002|Participant Flow|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
11132268|NCT01767519|OG000|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
10849035|NCT00293293|FG001|Participant Flow|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
11132269|NCT01767519|OG001|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
11132270|NCT01767519|OG002|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
11132271|NCT01767519|EG000|Reported Event|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
11132272|NCT01767519|EG001|Reported Event|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
11132273|NCT01767519|EG002|Reported Event|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
10849036|NCT00293293|OG000|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
11132274|NCT01767597|BG000|Baseline|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
11132275|NCT01767597|BG001|Baseline|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
11132276|NCT01767597|BG002|Baseline|Total|Total of all reporting groups
11132277|NCT01767597|FG000|Participant Flow|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
11132278|NCT01767597|FG001|Participant Flow|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
11132279|NCT01767597|OG000|Outcome|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
11132280|NCT01767597|OG001|Outcome|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
11132281|NCT01767597|EG000|Reported Event|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
11132282|NCT01767597|EG001|Reported Event|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
11132283|NCT01767636|BG000|Baseline|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11132284|NCT01767636|FG000|Participant Flow|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11132285|NCT01767636|OG000|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11132286|NCT01767636|EG000|Reported Event|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11132287|NCT01767688|BG000|Baseline|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
11132288|NCT01767688|BG001|Baseline|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
11132289|NCT01767688|BG002|Baseline|Total|Total of all reporting groups
11132290|NCT01767688|FG000|Participant Flow|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
11132291|NCT01767688|FG001|Participant Flow|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
11132292|NCT01767688|OG000|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
11132293|NCT01767688|OG001|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
11132294|NCT01767688|EG000|Reported Event|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
11132295|NCT01767688|EG001|Reported Event|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
11132296|NCT01767701|BG000|Baseline|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
11132297|NCT01767701|FG000|Participant Flow|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
11132298|NCT01767701|OG000|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
11132299|NCT01767701|OG000|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily. The EDSS score is determined by the mean score over three months after treatment minus the mean score of the three months before treatment~Raltegravir: 400mg twice daily for 3 months"
11132300|NCT01767701|EG000|Reported Event|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
11132301|NCT01767792|BG000|Baseline|Bevacizumab|"Follow participant for 2 years and assess hearing response rates~Bevacizumab: Treatment will be administered on an outpatient basis. Bevacizumab is administered by IV infusion at a dose of 10 mg/kg every 2 weeks for 24 weeks (induction therapy, see Schema). One cycle lasts 28 days and includes two infusions of bevacizumab. Clinical response will be assessed by audiology and MRI at weeks 12 and 24. Subjects with hearing decline at weeks 12 and 24 will be taken off of protocol. After week 24, patients with a clinical response or stable disease (together comprising clinical benefit) will transition to maintenance therapy with bevacizumab.~During the maintenance phase, subjects will be treated with open-label bevacizumab 5 mg/kg every 3 weeks for up to 72 weeks. Subjects will be followed with audiology and MRI scans every 12 weeks. The total time of the study will be 96 weeks (24 weeks induction + 72 weeks maintenance)."
11132302|NCT01767792|FG000|Participant Flow|Bevacizumab|Safety and tolerability of bevacizumab for 2 years. Change in hearing response will also be monitored.
11132303|NCT01767792|OG000|Outcome|Bevacizumab|Induction (high dose) therapy.
11132304|NCT01767792|OG000|Outcome|Bevacizumab|Maintenance (low dose) therapy.
11132305|NCT01767792|EG000|Reported Event|Bevacizumab|Safety and tolerability of bevacizumab for 2 years. Change in hearing response will also be monitored.
11132306|NCT01767857|BG000|Baseline|Xilonix|Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months).
11132307|NCT01767857|BG001|Baseline|Placebo|Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).
11132308|NCT01767857|BG002|Baseline|Total|Total of all reporting groups
11132309|NCT01767857|FG000|Participant Flow|Xilonix|Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months).
11132310|NCT01767857|FG001|Participant Flow|Placebo|Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).
11132311|NCT01767857|OG000|Outcome|Xilonix|Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months).
11132312|NCT01767857|OG001|Outcome|Placebo|Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).
11132313|NCT01767857|OG000|Outcome|Xilonix|Participants received 7.5 mg/kg Xilonix (MABp1) via IV injection once every 2 weeks until evidence of radiographic or clinical progression along with BSC (up to 18 months).
11132314|NCT01767857|EG000|Reported Event|Xilonix|Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months).
11132315|NCT01767857|EG001|Reported Event|Placebo|Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).
11132316|NCT01767909|BG000|Baseline|Insulin (Humulin® R U-100)|50% of participants received 20 IU BID intranasal insulin (Humulin® R U-100) twice daily for a total of 40 IU daily for 12 months, followed by a 6-month open label period.
11132317|NCT01767909|BG001|Baseline|Placebo|50% of participants received placebo treatment twice daily for 12 months followed by a 6-month open label period where all participants received 20 IU BID intranasal insulin (Humulin® R U-100) twice daily (total of 40 IU daily).
11132318|NCT01767909|BG002|Baseline|Total|Total of all reporting groups
11132319|NCT01767909|FG000|Participant Flow|Insulin (Humulin® R U-100)|20 IU BID intranasal insulin (Humulin® R U-100) twice daily for a total of 40 IU daily for 12 months, followed by a 6-month open label period.
11132320|NCT01767909|FG001|Participant Flow|Placebo|50% of participants received placebo treatment twice daily for 12 months followed by a 6-month open label period where all participants received 20 IU BID intranasal insulin (Humulin® R U-100) twice daily (total of 40 IU daily).
11132321|NCT01767909|OG000|Outcome|Insulin (Humulin® R U-100)|50% of participants received 20 IU BID intranasal insulin (Humulin® R U-100) twice daily for a total of 40 IU daily for 12 months, followed by a 6-month open label period.
11132322|NCT01767909|OG001|Outcome|Placebo|50% of participants received placebo treatment twice daily for 12 months followed by a 6-month open label period where all participants received 20 IU BID intranasal insulin (Humulin® R U-100) twice daily (total of 40 IU daily).
11149578|NCT01871532|OG001|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
11132323|NCT01767909|OG000|Outcome|Insulin (Humulin® R U-100)|"120 subjects will take two daily doses of INI (20 IU bid for a total daily dose of 40 IU) approximately 30 minutes after breakfast and dinner for 12 months. A 6-month open label period will follow in which all participants will receive INI.~Insulin (Humulin® R U-100): 20 IU bid taken twice daily (approximately 30 minutes after breakfast and dinner) for a total of 40 IU daily, which will be administered intranasally. The device used to administer insulin releases a metered dose into a chamber covering the participant's nose. The insulin is then inhaled by breathing evenly over a specified period."
11132324|NCT01767909|OG001|Outcome|Placebo|"120 subjects will take two daily doses of placebo approximately 30 minutes after breakfast and dinner for 12 months. A 6-month open label period will follow in which all participants will receive INI.~Placebo: Placebo taken twice daily (approximately 30 minutes after breakfast and dinner), which will be administered intranasally. The device used to administer placebo releases a metered dose into a chamber covering the participant's nose. The placebo is then inhaled by breathing evenly over a specified period."
11132325|NCT01767909|EG000|Reported Event|Insulin (Humulin® R U-100)|50% of participants received 20 IU BID intranasal insulin (Humulin® R U-100) twice daily for a total of 40 IU daily for 12 months, followed by a 6-month open label period.
11132326|NCT01767909|EG001|Reported Event|Placebo|50% of participants received placebo treatment twice daily for 12 months followed by a 6-month open label period where all participants received 20 IU BID intranasal insulin (Humulin® R U-100) twice daily (total of 40 IU daily).
11132327|NCT01767935|BG000|Baseline|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
11132328|NCT01767935|FG000|Participant Flow|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
11132329|NCT01767935|OG000|Outcome|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
11132330|NCT01767935|EG000|Reported Event|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
11132331|NCT01767987|BG000|Baseline|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
11132332|NCT01767987|BG001|Baseline|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
11132333|NCT01767987|BG002|Baseline|Total|Total of all reporting groups
11132334|NCT01767987|FG000|Participant Flow|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
11132335|NCT01767987|FG001|Participant Flow|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
11132336|NCT01767987|OG000|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
11132337|NCT01767987|OG001|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
11132338|NCT01767987|EG000|Reported Event|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
11132339|NCT01767987|EG001|Reported Event|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
11132340|NCT01768000|BG000|Baseline|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
11132341|NCT01768000|BG001|Baseline|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
10849037|NCT00293293|OG001|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
11132342|NCT01768000|BG002|Baseline|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11132343|NCT01768000|BG003|Baseline|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11132344|NCT01768000|BG004|Baseline|Total|Total of all reporting groups
11132345|NCT01768000|FG000|Participant Flow|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
11132346|NCT01768000|FG001|Participant Flow|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11132347|NCT01768000|FG002|Participant Flow|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
11132348|NCT01768000|FG003|Participant Flow|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11132349|NCT01768000|OG000|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
11132350|NCT01768000|OG001|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11132351|NCT01768000|OG002|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
11132352|NCT01768000|OG003|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11132353|NCT01768000|OG000|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
11132354|NCT01768000|OG001|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11149579|NCT01871532|EG000|Reported Event|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
11132355|NCT01768000|EG000|Reported Event|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
11132356|NCT01768000|EG001|Reported Event|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11132357|NCT01768000|EG002|Reported Event|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
11132358|NCT01768000|EG003|Reported Event|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
11132359|NCT01768013|BG000|Baseline|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
11132360|NCT01768013|FG000|Participant Flow|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
11132361|NCT01768013|OG000|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
11132362|NCT01768013|EG000|Reported Event|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
11132363|NCT01768117|BG000|Baseline|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
11132364|NCT01768117|FG000|Participant Flow|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
11132365|NCT01768117|OG000|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
11132366|NCT01768117|EG000|Reported Event|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
11132367|NCT01768286|BG000|Baseline|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
11132368|NCT01768286|BG001|Baseline|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
11132369|NCT01768286|BG002|Baseline|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
11132370|NCT01768286|BG003|Baseline|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11132371|NCT01768286|BG004|Baseline|Total|Total of all reporting groups
11132372|NCT01768286|FG000|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
11132373|NCT01768286|FG001|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
11132374|NCT01768286|FG002|Participant Flow|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
11132375|NCT01768286|FG003|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11132376|NCT01768286|OG000|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
11132377|NCT01768286|OG001|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
11132378|NCT01768286|OG002|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
11132379|NCT01768286|OG003|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11132380|NCT01768286|EG000|Reported Event|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
11132381|NCT01768286|EG001|Reported Event|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
11132382|NCT01768286|EG002|Reported Event|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
11132383|NCT01768286|EG003|Reported Event|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11132384|NCT01768325|BG000|Baseline|QuickCore Needle|
11132385|NCT01768325|BG001|Baseline|ProCore Needle|
11132386|NCT01768325|BG002|Baseline|Total|Total of all reporting groups
11132387|NCT01768325|FG000|Participant Flow|Quick Core Needle|
11132388|NCT01768325|FG001|Participant Flow|ProCore Needle|
11132389|NCT01768325|OG000|Outcome|Quick Core Needle|"Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle~Cook Medical core biopsy needle: Obtaining a larger specimen."
11132390|NCT01768325|OG001|Outcome|ProCore Needle|"Core biopsy needle comparison to obtain diagnostic yield.~Cook Medical core biopsy needle: Obtaining a larger specimen."
11132391|NCT01768325|OG000|Outcome|Quick Core Needle|
11132392|NCT01768325|OG001|Outcome|ProCore Needle|
11132393|NCT01768325|EG000|Reported Event|Quick Core Needle|
11132394|NCT01768325|EG001|Reported Event|ProCore Needle|
11132395|NCT01768520|BG000|Baseline|Entelon Tab. 150mg|Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
11132396|NCT01768520|BG001|Baseline|Celebrex Cap.|Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
11132397|NCT01768520|BG002|Baseline|Placebo|Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
11132398|NCT01768520|BG003|Baseline|Total|Total of all reporting groups
11132399|NCT01768520|FG000|Participant Flow|Entelon Tab. 150mg|Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
11132400|NCT01768520|FG001|Participant Flow|Celebrex Cap.|Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
11132401|NCT01768520|FG002|Participant Flow|Placebo|Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
11132402|NCT01768520|OG000|Outcome|Entelon Tab. 150mg|Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
11132403|NCT01768520|OG001|Outcome|Celebrex Cap.|Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
11132404|NCT01768520|OG002|Outcome|Placebo|Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
11132405|NCT01768520|EG000|Reported Event|Entelon Tab. 150mg|Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
11132406|NCT01768520|EG001|Reported Event|Celebrex Cap.|Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
11132407|NCT01768520|EG002|Reported Event|Placebo|Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
11132408|NCT01768559|BG000|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
11132409|NCT01768559|BG001|Baseline|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
11132410|NCT01768559|BG002|Baseline|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
11132411|NCT01768559|BG003|Baseline|Total|Total of all reporting groups
11132412|NCT01768559|FG000|Participant Flow|Lixisenatide|Lixisenatide 10 mcg once daily (QD) subcutaneously (SC) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
11132413|NCT01768559|FG001|Participant Flow|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
11132414|NCT01768559|FG002|Participant Flow|Insulin Glulisine TID|Insulin glulisine thrice daily (TID) SC up to Week 26 on top of insulin glargine with or without metformin.
11132415|NCT01768559|OG000|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
11132416|NCT01768559|OG001|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
11132417|NCT01768559|OG002|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
11132418|NCT01768559|OG000|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
11132419|NCT01768559|OG001|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
11132420|NCT01768559|OG001|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
11132421|NCT01768559|OG002|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
11132422|NCT01768559|EG000|Reported Event|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin (Median exposure of 182 days).
11132423|NCT01768559|EG001|Reported Event|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
11132424|NCT01768559|EG002|Reported Event|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
11132425|NCT01768572|BG000|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11132426|NCT01768572|BG001|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11132427|NCT01768572|BG002|Baseline|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
11132428|NCT01768572|BG003|Baseline|Total|Total of all reporting groups
11132429|NCT01768572|FG000|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks.
11132430|NCT01768572|FG001|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11132431|NCT01768572|FG002|Participant Flow|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
11132432|NCT01768572|OG000|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11132433|NCT01768572|OG001|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11132434|NCT01768572|OG002|Outcome|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
11132435|NCT01768572|EG000|Reported Event|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11132436|NCT01768572|EG001|Reported Event|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
11132437|NCT01768572|EG002|Reported Event|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.
11132438|NCT01768637|BG000|Baseline|Chronic Kidney Disease|"Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.~Aspirin: Aspirin 81 mg by mouth daily~Clopidogrel: Clopidogrel 75 mg by mouth once daily"
11132439|NCT01768637|BG001|Baseline|Normal Controls|"Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.~Aspirin: Aspirin 81 mg by mouth daily~Clopidogrel: Clopidogrel 75 mg by mouth once daily"
11132440|NCT01768637|BG002|Baseline|Total|Total of all reporting groups
11132441|NCT01768637|FG000|Participant Flow|Chronic Kidney Disease|"Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.~Aspirin: Aspirin 81 mg by mouth daily~Clopidogrel: Clopidogrel 75 mg by mouth once daily"
11132442|NCT01768637|FG001|Participant Flow|Normal Controls|"Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.~Aspirin: Aspirin 81 mg by mouth daily~Clopidogrel: Clopidogrel 75 mg by mouth once daily"
11132443|NCT01768637|OG000|Outcome|Chronic Kidney Disease|"Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.~Aspirin: Aspirin 81 mg by mouth daily~Clopidogrel: Clopidogrel 75 mg by mouth once daily"
11132444|NCT01768637|OG001|Outcome|Normal Controls|"Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.~Aspirin: Aspirin 81 mg by mouth daily~Clopidogrel: Clopidogrel 75 mg by mouth once daily"
11132445|NCT01768637|EG000|Reported Event|Chronic Kidney Disease|"Patients with pre-dialysis stages 4-5 Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.~Aspirin: Aspirin 81 mg by mouth daily~Clopidogrel: Clopidogrel 75 mg by mouth once daily"
11132446|NCT01768637|EG001|Reported Event|Normal Controls|"Patients without Chronic Kidney Disease will receive open-label aspirin 81 mg once daily for 2 weeks, then 2 weeks of aspirin 81 mg plus clopidogrel 75 mg once daily.~Aspirin: Aspirin 81 mg by mouth daily~Clopidogrel: Clopidogrel 75 mg by mouth once daily"
11132447|NCT01768676|BG000|Baseline|Avanafil|100 mg once daily in the evening
11132448|NCT01768676|BG001|Baseline|Placebo|placebo taken once daily in the evening
11132449|NCT01768676|BG002|Baseline|Total|Total of all reporting groups
11132450|NCT01768676|FG000|Participant Flow|Avanafil|100 mg once daily in the evening
11132451|NCT01768676|FG001|Participant Flow|Placebo|placebo taken once daily in the evening
11132452|NCT01768676|OG000|Outcome|Avanafil|100 mg once daily in the evening
11132453|NCT01768676|OG001|Outcome|Placebo|placebo taken once daily in the evening
11132454|NCT01768676|EG000|Reported Event|Avanafil|100 mg once daily in the evening
11132455|NCT01768676|EG001|Reported Event|Placebo|placebo taken once daily in the evening
11132456|NCT01768832|BG000|Baseline|Treadmill|"Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.~Treadmill"
11132457|NCT01768832|BG001|Baseline|Tango|"Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.~Tango"
11132458|NCT01768832|BG002|Baseline|Stretching|"Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.~Stretching"
11132459|NCT01768832|BG003|Baseline|Total|Total of all reporting groups
11132460|NCT01768832|FG000|Participant Flow|Treadmill|"Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.~Treadmill"
11132461|NCT01768832|FG001|Participant Flow|Tango|"Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.~Tango"
11132462|NCT01768832|FG002|Participant Flow|Stretching|"Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.~Stretching"
11132463|NCT01768832|OG000|Outcome|Treadmill|"Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.~Treadmill"
11132464|NCT01768832|OG001|Outcome|Tango|"Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.~Tango"
11132465|NCT01768832|OG002|Outcome|Stretching|"Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.~Stretching"
11132466|NCT01768832|EG000|Reported Event|Treadmill|"Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.~Treadmill"
11132467|NCT01768832|EG001|Reported Event|Tango|"Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.~Tango"
11132468|NCT01768832|EG002|Reported Event|Stretching|"Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.~Stretching"
11132469|NCT01768845|BG000|Baseline|Transplant|"After a preparative regimen the patient will receive an infusion of one or two umbilical cord blood unit(s) (UBC). The UBC unit(s) will be thawed according to methods of Rubinstein et al. If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis. On day +30, +60, +100, +180, and +365 the chimeric status of patients will be interpreted by variable number tandem repeat (VNTR) analysis. Immune reconstitution (Digeorge Panel) will also be checked at these time points.~umbilical cord blood (UCB): Infusion will occur after preparative regimen in one or two UCB unit(s). If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis."
11132470|NCT01768845|FG000|Participant Flow|Transplant|"After a preparative regimen the patient will receive an infusion of one or two umbilical cord blood unit(s) (UBC). The UBC unit(s) will be thawed according to methods of Rubinstein et al. If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for graft versus host disease (GVHD) prophylaxis. On day +30, +60, +100, +180, and +365 the chimeric status of patients will be interpreted by VNTR analysis. Immune reconstitution (Digeorge Panel) will also be checked at these time points.~umbilical cord blood (UCB): Infusion will occur after preparative regimen in one or two UCB unit(s). If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis."
11132471|NCT01768845|OG000|Outcome|Transplant|"After a preparative regimen the patient will receive an infusion of one or two umbilical cord blood unit(s) (UBC). The UBC unit(s) will be thawed according to methods of Rubinstein et al. If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis. On day +30, +60, +100, +180, and +365 the chimeric status of patients will be interpreted by VNTR analysis. Immune reconstitution (Digeorge Panel) will also be checked at these time points.~umbilical cord blood (UCB): Infusion will occur after preparative regimen in one or two UCB unit(s). If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis."
11132472|NCT01768845|EG000|Reported Event|Transplant|"After a preparative regimen the patient will receive an infusion of one or two umbilical cord blood unit(s) (UBC). The UBC unit(s) will be thawed according to methods of Rubinstein et al. If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis. On day +30, +60, +100, +180, and +365 the chimeric status of patients will be interpreted by VNTR analysis. Immune reconstitution (Digeorge Panel) will also be checked at these time points.~umbilical cord blood (UCB): Infusion will occur after preparative regimen in one or two UCB unit(s). If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis."
11132473|NCT01768858|BG000|Baseline|Participants Receiving Adalimumab|Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
11132474|NCT01768858|FG000|Participant Flow|Participants Receiving Adalimumab|Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
11132475|NCT01768858|OG000|Outcome|Participants Receiving Adalimumab|Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
11132476|NCT01768858|EG000|Reported Event|Participants Receiving Adalimumab|Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
11132477|NCT01769105|BG000|Baseline|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily, then a single Lipiflow-treatment"
11132478|NCT01769105|BG001|Baseline|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
11132479|NCT01769105|BG002|Baseline|Total|Total of all reporting groups
11132480|NCT01769105|FG000|Participant Flow|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow treatment"
11132481|NCT01769105|FG001|Participant Flow|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
11132482|NCT01769105|OG000|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
11132483|NCT01769105|OG001|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
11132484|NCT01769105|OG002|Outcome|Cross-over Lipiflow|patients received a single Lipiflow treatment after performing lid hygiene for 3 month
11132485|NCT01769105|OG002|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
11132486|NCT01769105|EG000|Reported Event|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily first and then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow-treatment"
11132487|NCT01769105|EG001|Reported Event|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
11132488|NCT01769170|BG000|Baseline|Brincidofovir|100 mg brincidofovir administered orally twice weekly
11132489|NCT01769170|BG001|Baseline|Placebo|Matching placebo administered orally twice weekly
11132490|NCT01769170|BG002|Baseline|Total|Total of all reporting groups
11132491|NCT01769170|FG000|Participant Flow|Brincidofovir|100 mg brincidofovir administered orally twice weekly
11132492|NCT01769170|FG001|Participant Flow|Placebo|Matching placebo administered orally twice weekly
11132493|NCT01769170|OG000|Outcome|Brincidofovir|100 mg brincidofovir administered orally twice weekly
11132494|NCT01769170|OG001|Outcome|Placebo|Matching placebo administered orally twice weekly
11132495|NCT01769170|EG000|Reported Event|Brincidofovir|100 mg brincidofovir administered orally twice weekly
11132496|NCT01769170|EG001|Reported Event|Placebo|Matching placebo administered orally twice weekly
11132497|NCT01769196|BG000|Baseline|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
11132498|NCT01769196|BG001|Baseline|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
11132499|NCT01769196|BG002|Baseline|Total|Total of all reporting groups
11132500|NCT01769196|FG000|Participant Flow|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
11132501|NCT01769196|FG001|Participant Flow|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
11132502|NCT01769196|OG000|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
11132503|NCT01769196|OG001|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
11132504|NCT01769196|EG000|Reported Event|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
11132505|NCT01769196|EG001|Reported Event|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
11132506|NCT01769209|BG000|Baseline|Bortezomib + Chemotherapy|"Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.~Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.~Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.~PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.~Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.~Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.~Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1~Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15."
11132507|NCT01769209|FG000|Participant Flow|Bortezomib + Chemotherapy|"Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.~Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.~Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.~PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.~Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.~Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.~Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1~Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15."
11132508|NCT01769209|OG000|Outcome|Bortezomib + Chemotherapy|"Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.~Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.~Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.~PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.~Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.~Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.~Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1~Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15."
11132509|NCT01769209|EG000|Reported Event|Bortezomib + Chemotherapy|"Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.~Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.~Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.~PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.~Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.~Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.~Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1~Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15."
11132510|NCT01769222|BG000|Baseline|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
11132511|NCT01769222|BG001|Baseline|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
11132512|NCT01769222|BG002|Baseline|Total|Total of all reporting groups
11132513|NCT01769222|FG000|Participant Flow|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
11132514|NCT01769222|FG001|Participant Flow|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
11132515|NCT01769222|OG000|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
11132516|NCT01769222|OG001|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
11132517|NCT01769222|EG000|Reported Event|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
11132518|NCT01769222|EG001|Reported Event|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
11132519|NCT01769248|BG000|Baseline|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
11132520|NCT01769248|BG001|Baseline|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
11132521|NCT01769248|BG002|Baseline|Total|Total of all reporting groups
11132522|NCT01769248|FG000|Participant Flow|Fine Needle Aspiration (FNA)|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration using endoscopic ultrasound-FNA needles. This was the standard of care arm"
11132523|NCT01769248|FG001|Participant Flow|Fine Needle Biopsy (FNB)|"Fine Needle biopsy~Fine Needle biopsy: FNB, test arm for core biopsies, endoscopic ultrasound-FNB"
11132524|NCT01769248|OG000|Outcome|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
11132525|NCT01769248|OG001|Outcome|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
11132526|NCT01769248|OG000|Outcome|Fine Needle Aspiration to Fine Needle Biopsy|"fine needle aspiration to fine needle biopsy~EUS-FNA to EUS-FNB"
11132527|NCT01769248|OG001|Outcome|Fine Needle Biopsy to Fine Needle Aspiration|"Fine needle biopsy to fine needle aspiration~EUS-FNB to EUS-FNA"
11132528|NCT01769248|EG000|Reported Event|Fine Needle Aspiration|Fine needle aspiration: Fine needle aspiration
11132529|NCT01769248|EG001|Reported Event|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
11132530|NCT01769274|BG000|Baseline|All Participants|All participants who were enrolled in the study.
10849038|NCT00293293|OG000|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
11132531|NCT01769274|FG000|Participant Flow|Part A|Participants were exposed to pain stimulus. Reproducibility and repeatability of induced pain attacks and spontaneous reporting of pain by participants was established. Part A was performed for 1-2 days and maximum up to 7 days. Maximum duration between Part A and Part B was of 4 weeks.
11132532|NCT01769274|FG001|Participant Flow|Part B: PF-05089771 Then Placebo Then Placebo Then PF-05089771|On completion of Part A, participants were randomized in Part B. Part B: Participants were randomized to receive oral dispersion of PF-05089771 1600 milligram (mg) on Day 1 of Treatment session 1 (Study Period 1), followed by washout of 72 hours. Then, participants received oral dispersion of placebo matched to PF-05089771 on Day 5 of Treatment session 1 (Study Period 2). Treatment session 1 was followed by washout of 72 hours and then Treatment session 2. On Day 1 of Treatment session 2 (Study Period 3), participants received oral dispersion of placebo matched to PF-05089771, followed by washout of 72 hours. Then, participants received oral dispersion of PF-05089771 1600 mg on Day 5 of Treatment session 2 (Study Period 4). Maximum permitted interval between Study Period 2 completion and the start of Study Period 3 is 6 months.
11132533|NCT01769274|FG002|Participant Flow|Part B: Placebo Then PF-05089771 Then PF-05089771 Then Placebo|On completion of Part A, participants were randomized in Part B. Part B: Participants were randomized to receive oral dispersion of placebo matched to PF-05089771 on Day 1 of Treatment session 1 (Study Period 1), followed by washout of 72 hours. Then, participants received oral dispersion of PF-05089771 1600 mg on Day 5 of Treatment session 1 (Study Period 2). Treatment session 1 was followed by washout of 72 hours and then Treatment session 2. On Day 1 of Treatment session 2 (Study Period 3), participants received oral dispersion of PF-05089771 1600 mg, followed by washout of 72 hours. Then, participants received oral dispersion of placebo matched to PF-05089771 on Day 5 of Treatment session 2 (Study Period 4). Maximum permitted interval between Study Period 2 completion and the start of Study Period 3 is 6 months.
11132534|NCT01769274|OG000|Outcome|Treatment Session 1: PF-05089771 1600 mg|Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
11132535|NCT01769274|OG001|Outcome|Treatment Session 1: Placebo|Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
11132536|NCT01769274|OG002|Outcome|Treatment Session 2: PF-05089771 1600 mg|Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
11132537|NCT01769274|OG003|Outcome|Treatment Session 2: Placebo|Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
11132538|NCT01769274|OG001|Outcome|Treatment Session 2: PF-05089771 1600 mg|Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
11132539|NCT01769274|EG000|Reported Event|Treatment Session 1: PF-05089771 1600 mg|Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
11132540|NCT01769274|EG001|Reported Event|Treatment Session 1: Placebo|Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
11132541|NCT01769274|EG002|Reported Event|Treatment Session 2: PF-05089771 1600 mg|Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
11132542|NCT01769274|EG003|Reported Event|Treatment Session 2: Placebo|Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
11132543|NCT01769326|BG000|Baseline|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
11132544|NCT01769326|BG001|Baseline|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
11132545|NCT01769326|BG002|Baseline|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
11132546|NCT01769326|BG003|Baseline|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
11132547|NCT01769326|BG004|Baseline|Total|Total of all reporting groups
11132548|NCT01769326|FG000|Participant Flow|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
11132549|NCT01769326|FG001|Participant Flow|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
11132550|NCT01769326|FG002|Participant Flow|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
11132551|NCT01769326|FG003|Participant Flow|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
11132552|NCT01769326|OG000|Outcome|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
11132553|NCT01769326|OG001|Outcome|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
11132554|NCT01769326|OG000|Outcome|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
11132555|NCT01769326|OG001|Outcome|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
11132556|NCT01769326|EG000|Reported Event|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
11132557|NCT01769326|EG001|Reported Event|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
11132558|NCT01769326|EG002|Reported Event|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
11132559|NCT01769326|EG003|Reported Event|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
11132560|NCT01769339|BG000|Baseline|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
11132561|NCT01769339|FG000|Participant Flow|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically (applied to skin) to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis (yeast infection of the vulva) were not cured clinically on Day 14.
11132562|NCT01769339|OG000|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
11132563|NCT01769339|EG000|Reported Event|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
10849039|NCT00293293|EG000|Reported Event|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
10849040|NCT00293293|EG001|Reported Event|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
11132564|NCT01769352|BG000|Baseline|Post-Cataract Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
11132565|NCT01769352|BG001|Baseline|Post-Cataract Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
11132566|NCT01769352|BG002|Baseline|Post-Other Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
11132567|NCT01769352|BG003|Baseline|Post-Other Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
11132568|NCT01769352|BG004|Baseline|Total|Total of all reporting groups
11132569|NCT01769352|FG000|Participant Flow|Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1|"Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)~PredA + Kelac: At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given."
11132570|NCT01769352|FG001|Participant Flow|Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2|"Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)~PredA + Kelac: At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12."
11132571|NCT01769352|FG002|Participant Flow|Post-Other Surgery CME (PredA q1h + Kelac Qid) - Group 1|"Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)~PredA + Kelac: At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given."
11132572|NCT01769352|FG003|Participant Flow|Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2|"Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)~PredA + Kelac: At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12."
11132573|NCT01769352|OG000|Outcome|Post-Cataract Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
11132574|NCT01769352|OG001|Outcome|Post-Cataract Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
11132575|NCT01769352|OG002|Outcome|Post-Other Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
11132576|NCT01769352|OG003|Outcome|Post-Other Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
11132577|NCT01769352|OG000|Outcome|Prednisolone Acetate Switched From 4 Hours to Every 1 Hour|Patients who switched from Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hours to every 1 hour while awake at week 12.
11132578|NCT01769352|OG001|Outcome|Prednisolone Acetate Continued Every 1 Hour|Patients who continued on Prednisolone Acetate (PredA) 1% ophthalmic solution continued every 1 hour while awake at week 12.
11132579|NCT01769352|OG002|Outcome|Prednisolone Acetate Switched From Every 1 Hour to 4 Hours|Patients who switched from Prednisolone Acetate (PredA) 1% ophthalmic solution from every 1 hours while awake to every 4 hours at week 12.
11132580|NCT01769352|EG000|Reported Event|Prednisolone Acetate Every 1 Hour While Awake (Group 1)|"Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution every 1 hour while awake.~Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA every 1 hour (q1h) - Group 1."
11132581|NCT01769352|EG001|Reported Event|Prednisolone Acetate Four Times a Day (Group 2)|"Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution four times a day~Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA four times a day (qid) - Group 2."
11132582|NCT01769365|BG000|Baseline|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
11132583|NCT01769365|BG001|Baseline|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
11132584|NCT01769365|BG002|Baseline|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
11132585|NCT01769365|BG003|Baseline|Total|Total of all reporting groups
11132586|NCT01769365|FG000|Participant Flow|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
11132587|NCT01769365|FG001|Participant Flow|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
11132588|NCT01769365|FG002|Participant Flow|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
11132589|NCT01769365|OG000|Outcome|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
11132590|NCT01769365|OG001|Outcome|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
11132591|NCT01769365|OG002|Outcome|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
11132592|NCT01769365|EG000|Reported Event|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
11132593|NCT01769365|EG001|Reported Event|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
11132594|NCT01769365|EG002|Reported Event|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
11132595|NCT01769378|BG000|Baseline|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
11132596|NCT01769378|BG001|Baseline|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
11132597|NCT01769378|BG002|Baseline|Total|Total of all reporting groups
11132598|NCT01769378|FG000|Participant Flow|Dulaglutide|Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
11132599|NCT01769378|FG001|Participant Flow|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
11132600|NCT01769378|OG000|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
11132601|NCT01769378|OG001|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
11132602|NCT01769378|EG000|Reported Event|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
11132603|NCT01769378|EG001|Reported Event|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
11132604|NCT01769391|BG000|Baseline|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
11132605|NCT01769391|BG001|Baseline|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
11132606|NCT01769391|BG002|Baseline|Total|Total of all reporting groups
11132607|NCT01769391|FG000|Participant Flow|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
11132608|NCT01769391|FG001|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
11132609|NCT01769391|OG000|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
11132610|NCT01769391|OG001|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
11132611|NCT01769391|OG001|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
11132612|NCT01769391|OG000|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
11132613|NCT01769391|OG000|Outcome|Necitumumab + Paclitaxel+ Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
11132614|NCT01769391|OG000|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
11132615|NCT01769391|OG001|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
11132616|NCT01769391|OG000|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
11132617|NCT01769391|EG000|Reported Event|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
11132618|NCT01769391|EG001|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
11132619|NCT01769404|BG000|Baseline|All Participants|All participants who received at least 1 dose of study drug.
11132620|NCT01769404|FG000|Participant Flow|Cohort 1 (LY2605541, Then Insulin Glargine)|Participants received a stable dose of 0.2 to 0.6 U/kg LY2605541, administered subcutaneously (SQ), once daily for 14 days in Treatment Period 1, followed by a stable dose of 0.2 to 0.6 U/kg insulin glargine, administered SQ, once daily for 14 days in Treatment Period 2.
11132621|NCT01769404|FG001|Participant Flow|Cohort 2 (Insulin Glargine, Then LY2605541)|Participants received a stable dose of 0.2 to 0.6 U/kg insulin glargine, administered SQ, once daily for 14 days in Treatment Period 1, followed by a stable dose of 0.2 to 0.6 U/kg LY2605541, administered SQ, once daily for 14 days in Treatment Period 2.
11132622|NCT01769404|OG000|Outcome|LY2605541|Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.
11132623|NCT01769404|OG001|Outcome|Insulin Glargine|Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.
11132624|NCT01769404|EG000|Reported Event|Cohort 1: 0.2-0.6 U/kg LY2605541|Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen.
11132625|NCT01769404|EG001|Reported Event|Cohort 1: 0.2-0.6 U/kg Insulin Glargine|Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen.
11132626|NCT01769404|EG002|Reported Event|Cohort 2: 0.2-0.6 U/kg LY2605541|Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen.
11132627|NCT01769404|EG003|Reported Event|Cohort 2: 0.2-0.6 U/kg Insulin Glargine|Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen.
11132628|NCT01769456|BG000|Baseline|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11132629|NCT01769456|FG000|Participant Flow|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11132630|NCT01769456|OG000|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
11132631|NCT01769456|OG000|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."
11132632|NCT01769456|EG000|Reported Event|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
11132633|NCT01769469|BG000|Baseline|Subjects Enrolled in ATN 110 or ATN 113|"A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.~FTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113."
11132634|NCT01769469|FG000|Participant Flow|Subjects Enrolled in ATN 110 or ATN 113|"A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir (TDF)/emtricitabine (FTC) (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.~FTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113."
11132635|NCT01769469|OG000|Outcome|Subjects Enrolled in ATN 110 or ATN 113|"A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.~FTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113."
11132636|NCT01769469|OG000|Outcome|High Exposure Group|Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.
11132637|NCT01769469|OG001|Outcome|Low Exposure Group|Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.
11132638|NCT01769469|EG000|Reported Event|Subjects Enrolled in ATN 110 or ATN 113|"A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.~FTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113."
11132639|NCT01769508|BG000|Baseline|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
11132640|NCT01769508|FG000|Participant Flow|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
11132641|NCT01769508|OG000|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
11132642|NCT01769508|EG000|Reported Event|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
11132643|NCT01769573|BG000|Baseline|100 TCID50|"RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132644|NCT01769573|BG001|Baseline|500 TCID50|"RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132645|NCT01769573|BG002|Baseline|1,000 TCID50|"RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132646|NCT01769573|BG003|Baseline|10,000 TCID50|"RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132647|NCT01769573|BG004|Baseline|Placebo|"Diluent administered intranasally (0.25ml per nostril) one time.~Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml."
11132648|NCT01769573|BG005|Baseline|Total|Total of all reporting groups
11132649|NCT01769573|FG000|Participant Flow|100 TCID50|"RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132650|NCT01769573|FG001|Participant Flow|500 TCID50|"RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132651|NCT01769573|FG002|Participant Flow|1,000 TCID50|"RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132652|NCT01769573|FG003|Participant Flow|10,000 TCID50|"RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132653|NCT01769573|FG004|Participant Flow|Placebo|"Diluent administered intranasally (0.25ml per nostril) one time.~Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml."
11132654|NCT01769573|OG000|Outcome|100 TCID50|"RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132655|NCT01769573|OG001|Outcome|500 TCID50|"RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132656|NCT01769573|OG002|Outcome|1,000 TCID50|"RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132657|NCT01769573|OG003|Outcome|10,000 TCID50|"RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132658|NCT01769573|OG004|Outcome|Placebo|"Diluent administered intranasally (0.25ml per nostril) one time.~Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml."
11132659|NCT01769573|EG000|Reported Event|100 TCID50|"RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132660|NCT01769573|EG001|Reported Event|500 TCID50|"RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132661|NCT01769573|EG002|Reported Event|1,000 TCID50|"RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132662|NCT01769573|EG003|Reported Event|10,000 TCID50|"RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.~RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin"
11132663|NCT01769573|EG004|Reported Event|Placebo|"Diluent administered intranasally (0.25ml per nostril) one time.~Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml."
11132664|NCT01769586|BG000|Baseline|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
11132665|NCT01769586|BG001|Baseline|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
11132666|NCT01769586|BG002|Baseline|Total|Total of all reporting groups
11132667|NCT01769586|FG000|Participant Flow|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
11132668|NCT01769586|FG001|Participant Flow|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
11132669|NCT01769586|OG000|Outcome|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
11132670|NCT01769586|OG001|Outcome|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
11132671|NCT01769586|EG000|Reported Event|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
11132672|NCT01769586|EG001|Reported Event|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
11132673|NCT01769612|BG000|Baseline|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays~No Intervention"
11132674|NCT01769612|FG000|Participant Flow|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays~No Intervention"
11132675|NCT01769612|OG000|Outcome|CL Detect Rapid Test|Data for CL Detect Rapid Test
11132676|NCT01769612|OG001|Outcome|Microscopy|Data for Micrscopy
11132677|NCT01769612|OG002|Outcome|Culture|Data for Culture results
11132678|NCT01769612|EG000|Reported Event|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays~No Intervention"
11149580|NCT01871532|EG001|Reported Event|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
11132679|NCT01770145|BG000|Baseline|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
11132680|NCT01770145|FG000|Participant Flow|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
11132681|NCT01770145|OG000|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
11132682|NCT01770145|EG000|Reported Event|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
11132683|NCT01770314|BG000|Baseline|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
11132684|NCT01770314|BG001|Baseline|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
11132685|NCT01770314|BG002|Baseline|Total|Total of all reporting groups
11132686|NCT01770314|FG000|Participant Flow|Control|The control group was a waitlist control. Participants were given access to the experimental intervention program after the intervention period and follow up assessments were completed.
11132687|NCT01770314|FG001|Participant Flow|Experimental|Participants were given instructions via email to review eleven online lessons about opioid medication safety. Instructions suggested that participants view one lesson per day for eleven consecutive days. Each educational lesson focused on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
11132688|NCT01770314|OG000|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
11132689|NCT01770314|OG001|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
11132690|NCT01770314|EG000|Reported Event|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
11132691|NCT01770314|EG001|Reported Event|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
11132692|NCT01770353|BG000|Baseline|Pilot Phase: FMX Then MM-398|"FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132693|NCT01770353|BG001|Baseline|Expansion Phase: FMX Then MM-398|"FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.~Cohort 1: ER and/or PR-positive BC and HER-2 negative BC. Cohort 2: TNBC. Cohort 3: BC with active brain metastasis."
11132694|NCT01770353|BG002|Baseline|Total|Total of all reporting groups
11149581|NCT01871545|BG000|Baseline|Hepatocellular Carcinoma (HCC)|Participants with hepatocellular carcinoma (HCC)
11149582|NCT01871545|BG001|Baseline|Healthy Participant|Healthy control participants
11149583|NCT01871545|BG002|Baseline|Total|Total of all reporting groups
11149584|NCT01871545|FG000|Participant Flow|Hepatocellular Carcinoma (HCC)|Participant with hepatocellular carcinoma (HCC)
11132695|NCT01770353|FG000|Participant Flow|Pilot Phase: FMX Then MM-398|"FMX phase: Subjects received a single bolus intravenous (IV) injection of 5 milligrams per kilogram (mg/kg) FMX (up to 510 mg) on Day 1. Subjects underwent FMX magnetic resonance imaging (MRI) scans and pre-MM-398 treatment biopsies on Days 1 to 4.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 milligrams per square metre (mg/m^2) MM-398 free base equivalent (FBE) (Cycle 1 Day 1 [C1D1]) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132696|NCT01770353|FG001|Participant Flow|Expansion Phase: FMX Then MM-398|"FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.~Cohort 1: Oestrogen receptor (ER) and/or progesterone receptor (PR)-positive BC and human epidermal growth factor receptor 2 (HER-2) negative BC.~Cohort 2: Triple negative BC (TNBC). Cohort 3: BC with active brain metastasis."
11132697|NCT01770353|OG000|Outcome|Pilot Phase: FMX Then MM-398|"FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132698|NCT01770353|OG000|Outcome|Expansion Phase: Cohort 1|"Subjects with ER and/or PR-positive BC and HER-2 negative BC.~FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132699|NCT01770353|OG001|Outcome|Expansion Phase: Cohort 2|"Subjects with TNBC.~FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132700|NCT01770353|OG002|Outcome|Expansion Phase: Cohort 3|"Subjects with BC with active brain metastasis.~FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132701|NCT01770353|OG001|Outcome|Expansion Phase: Cohort 1|"Subjects with ER and/or PR-positive BC and HER-2 negative BC.~FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132702|NCT01770353|OG002|Outcome|Expansion Phase: Cohort 2|"Subjects with TNBC.~FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132703|NCT01770353|OG003|Outcome|Expansion Phase: Cohort 3|"Subjects with BC with active brain metastasis.~FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132704|NCT01770353|OG000|Outcome|Expansion Phase: Cohort 3|"Subjects with BC with active brain metastasis.~FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132705|NCT01770353|OG001|Outcome|Expansion Phase: FMX Then MM-398|"FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.~Cohort 1: ER and/or PR-positive BC and HER-2 negative BC. Cohort 2: TNBC. Cohort 3: BC with active brain metastasis."
11132706|NCT01770353|OG000|Outcome|Expansion Phase: FMX Then MM-398|"FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.~Cohort 1: ER and/or PR-positive BC and HER-2 negative BC. Cohort 2: TNBC. Cohort 3: BC with active brain metastasis."
10849116|NCT00294047|EG001|Reported Event|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11132707|NCT01770353|EG000|Reported Event|Pilot Phase: FMX Then MM-398|"FMX phase: Subjects received a single bolus IV injection of 5 mg/kg FMX (up to 510 mg) on Day 1. Subjects underwent FMX-MRI scans and pre-MM-398 treatment biopsies on Days 1 to 4.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent."
11132708|NCT01770353|EG001|Reported Event|Expansion Phase: FMX Then MM-398|"FMX phase: Subjects received an IV infusion of 5 mg/kg FMX (up to 510 mg) administered over a minimum of 15 minutes on Day 1. Subjects underwent FMX-MRI scans and a pre-MM-398 treatment biopsy on Days 1 to 2.~MM-398 Treatment phase: Within 7 days of the FMX infusion, subjects received up to 70 mg/m^2 MM-398 FBE (C1D1) administered as an IV infusion over 90 minutes, repeated every 2 weeks until disease progression, unacceptable toxicity or withdrawal of consent.~Cohort 1: ER and/or PR-positive BC and HER-2 negative BC. Cohort 2: TNBC. Cohort 3: BC with active brain metastasis."
11132709|NCT01770366|BG000|Baseline|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
11132710|NCT01770366|BG001|Baseline|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
11132711|NCT01770366|BG002|Baseline|Total|Total of all reporting groups
11132712|NCT01770366|FG000|Participant Flow|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
11132713|NCT01770366|FG001|Participant Flow|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
11132714|NCT01770366|OG000|Outcome|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
11132715|NCT01770366|OG001|Outcome|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
11132716|NCT01770366|EG000|Reported Event|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
11132717|NCT01770366|EG001|Reported Event|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
11132718|NCT01770379|BG000|Baseline|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
11132719|NCT01770379|BG001|Baseline|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
11132720|NCT01770379|BG002|Baseline|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
11132721|NCT01770379|BG003|Baseline|Total|Total of all reporting groups
11132722|NCT01770379|FG000|Participant Flow|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
11132723|NCT01770379|FG001|Participant Flow|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
11132724|NCT01770379|FG002|Participant Flow|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
11132725|NCT01770379|OG000|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
11132726|NCT01770379|OG001|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
11132727|NCT01770379|OG002|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
10849117|NCT00294060|BG000|Baseline|Pacing Patients|Patients implanted with a pacemaker.
11132728|NCT01770379|OG000|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status
11132729|NCT01770379|OG001|Outcome|AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
11132730|NCT01770379|EG000|Reported Event|Any AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
11132731|NCT01770379|EG001|Reported Event|Any AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
11132732|NCT01770379|EG002|Reported Event|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
11132733|NCT01770392|BG000|Baseline|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
11132734|NCT01770392|FG000|Participant Flow|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
11132735|NCT01770392|OG000|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
11132736|NCT01770392|OG001|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
11132737|NCT01770392|OG000|Outcome|Nintedanib|150 mg of Nintedanib was given as a single dose on Day 1.
11132738|NCT01770392|OG001|Outcome|Nintedanib + Rifampicin|600 mg Rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
11132739|NCT01770392|EG000|Reported Event|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
11132740|NCT01770392|EG001|Reported Event|Washout Period|washout period of at least 14 days between the administrations of nintedanib. During this period no trial drug was administered
11132741|NCT01770392|EG002|Reported Event|Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1
11132742|NCT01770392|EG003|Reported Event|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
11132743|NCT01770431|BG000|Baseline|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
10849118|NCT00294060|FG000|Participant Flow|Pacing Patients|Patients implanted with a pacemaker.
10849119|NCT00294060|OG000|Outcome|Pacing Patients|Patients implanted with a pacemaker.
10849120|NCT00294060|EG000|Reported Event|Pacing Patients|Patients implanted with a pacemaker.
11132744|NCT01770431|BG001|Baseline|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
11132745|NCT01770431|BG002|Baseline|Total|Total of all reporting groups
11132746|NCT01770431|FG000|Participant Flow|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
11132747|NCT01770431|FG001|Participant Flow|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
11132748|NCT01770431|OG000|Outcome|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
11132749|NCT01770431|OG001|Outcome|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
11132750|NCT01770431|OG001|Outcome|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles."
11149585|NCT01871545|FG001|Participant Flow|Healthy Volunteer|Healthy volunteer participant
11132751|NCT01770431|EG000|Reported Event|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
11132752|NCT01770431|EG001|Reported Event|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
11132753|NCT01770483|BG000|Baseline|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
11132754|NCT01770483|BG001|Baseline|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
11132755|NCT01770483|BG002|Baseline|Total|Total of all reporting groups
11132756|NCT01770483|FG000|Participant Flow|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
11132757|NCT01770483|FG001|Participant Flow|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
11132758|NCT01770483|OG000|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
11132759|NCT01770483|OG001|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
11132760|NCT01770483|EG000|Reported Event|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
11132761|NCT01770483|EG001|Reported Event|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
11132762|NCT01770509|BG000|Baseline|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
11132763|NCT01770509|BG001|Baseline|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
11132764|NCT01770509|BG002|Baseline|Total|Total of all reporting groups
11132765|NCT01770509|FG000|Participant Flow|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
11132766|NCT01770509|FG001|Participant Flow|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
11132767|NCT01770509|OG000|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
11132768|NCT01770509|OG001|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
11132769|NCT01770509|EG000|Reported Event|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
11132770|NCT01770509|EG001|Reported Event|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
10849121|NCT00294398|BG000|Baseline|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and are provided a home nebulizer if needed.
11132771|NCT01770652|BG000|Baseline|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132772|NCT01770652|BG001|Baseline|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132773|NCT01770652|BG002|Baseline|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132774|NCT01770652|BG003|Baseline|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132775|NCT01770652|BG004|Baseline|Total|Total of all reporting groups
11149586|NCT01871545|OG000|Outcome|Hepatocellular Carcinoma (HCC)|Participants with hepatocellular carcinoma (HCC)
11132776|NCT01770652|FG000|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132777|NCT01770652|FG001|Participant Flow|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132778|NCT01770652|FG002|Participant Flow|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132779|NCT01770652|FG003|Participant Flow|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132780|NCT01770652|OG000|Outcome|Normal Renal Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132781|NCT01770652|OG001|Outcome|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132782|NCT01770652|OG002|Outcome|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132783|NCT01770652|OG003|Outcome|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132784|NCT01770652|OG000|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
11132785|NCT01770652|OG001|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
11132786|NCT01770652|OG002|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
11132787|NCT01770652|OG003|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
11132788|NCT01770652|EG000|Reported Event|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132789|NCT01770652|EG001|Reported Event|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132790|NCT01770652|EG002|Reported Event|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132791|NCT01770652|EG003|Reported Event|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
11132792|NCT01770691|BG000|Baseline|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
11132793|NCT01770691|FG000|Participant Flow|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all SMD'S~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
11132794|NCT01770691|OG000|Outcome|SMD 12 2008|5 subjects used SMD 12 for up to 8 hours during 2008
11132795|NCT01770691|OG001|Outcome|SMD 12 2009|6 subjects used SMD 12 for up to 8 hours during 2009
11132796|NCT01770691|OG002|Outcome|SMD 9|7 subjects used SMD 9 for up to 8 hours
11132797|NCT01770691|OG003|Outcome|Cleared TIPI Device (G3)|7 subjects used the cleared TIPI G3 for up to 8 hours
11132798|NCT01770691|EG000|Reported Event|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
11132799|NCT01770743|BG000|Baseline|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132800|NCT01770743|BG001|Baseline|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132801|NCT01770743|BG002|Baseline|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132802|NCT01770743|BG003|Baseline|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132803|NCT01770743|BG004|Baseline|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
11132804|NCT01770743|BG005|Baseline|Total|Total of all reporting groups
11132805|NCT01770743|FG000|Participant Flow|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132806|NCT01770743|FG001|Participant Flow|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132807|NCT01770743|FG002|Participant Flow|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132808|NCT01770743|FG003|Participant Flow|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132809|NCT01770743|FG004|Participant Flow|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
11132810|NCT01770743|OG000|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132811|NCT01770743|OG001|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132812|NCT01770743|OG002|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132813|NCT01770743|OG003|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132814|NCT01770743|OG004|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
11132815|NCT01770743|EG000|Reported Event|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132816|NCT01770743|EG001|Reported Event|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132817|NCT01770743|EG002|Reported Event|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132818|NCT01770743|EG003|Reported Event|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
11132819|NCT01770743|EG004|Reported Event|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
11132820|NCT01770860|BG000|Baseline|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
11132821|NCT01770860|FG000|Participant Flow|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
11132822|NCT01770860|OG000|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
11132823|NCT01770860|OG001|Outcome|Bandage QuiltVent™ Sheer Strips|
11132824|NCT01770860|OG002|Outcome|Bandage QuiltVent™ Flexible Fabric|
11132825|NCT01770860|OG003|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
11132826|NCT01770860|OG004|Outcome|Bandage Dora the Explorer™|
11132827|NCT01770860|EG000|Reported Event|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
11132828|NCT01770912|BG000|Baseline|Lactated Ringers|"1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.~Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure."
11132829|NCT01770912|BG001|Baseline|Triamcinolone Acetonide|"1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.~Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure."
11132830|NCT01770912|BG002|Baseline|Total|Total of all reporting groups
11132831|NCT01770912|FG000|Participant Flow|Lactated Ringers|"1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.~Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure."
11132832|NCT01770912|FG001|Participant Flow|Triamcinolone Acetonide|"1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.~Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure."
11132833|NCT01770912|OG000|Outcome|Lactated Ringers|"1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.~Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure."
11132834|NCT01770912|OG001|Outcome|Triamcinolone Acetonide|"1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.~Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure."
11132835|NCT01770912|EG000|Reported Event|Lactated Ringers|"1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.~Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure."
11132836|NCT01770912|EG001|Reported Event|Triamcinolone Acetonide|"1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.~Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure."
11132837|NCT01771055|BG000|Baseline|Galactose|"Galactose~Galactose: Galactose dripped into the abdomen after surgery"
11132838|NCT01771055|BG001|Baseline|Standard Resuscitation|"Standard surgical methods of controlling bleeding~Standard surgical methods"
11132839|NCT01771055|BG002|Baseline|Total|Total of all reporting groups
11132840|NCT01771055|FG000|Participant Flow|Control|Standard of care without peritoneal resuscitation
11132841|NCT01771055|FG001|Participant Flow|Direct Peritoneal Resuscitation|Subjects received standard operation plus direct peritoneal resuscitation after surgery
11132842|NCT01771055|OG000|Outcome|Galactose|"Galactose~Galactose: Galactose dripped into the abdomen after surgery"
11132843|NCT01771055|OG001|Outcome|Standard Resuscitation|"Standard surgical methods of controlling bleeding~Standard surgical methods without galactose"
11132844|NCT01771055|EG000|Reported Event|Galactose|"Galactose~Galactose: Galactose dripped into the abdomen after surgery"
11132845|NCT01771055|EG001|Reported Event|Standard Resuscitation|"Standard surgical methods of controlling bleeding~Standard surgical methods"
11132846|NCT01771172|BG000|Baseline|Acute Defibrillation Testing|
11132847|NCT01771172|FG000|Participant Flow|Acute Defibrillation Testing|
11132848|NCT01771172|OG000|Outcome|Acute Defibrillation Testing|
11132849|NCT01771172|EG000|Reported Event|Acute Defibrillation Testing|
11132850|NCT01771250|BG000|Baseline|All Study Participants|Participants were randomized to receive daily stable doses of either insulin peglispro or insulin glargine (0.2 -0.8 U/kg) administered SC for at least 21 days, in one of two treatment periods.
11132851|NCT01771250|FG000|Participant Flow|Insulin Peglispro (LY2605541) Then Insulin Glargine|Participants took a stable dose of insulin peglispro (0.2 - 0.8 Units per kilogram [U/kg]) in Period 1 and then insulin glargine (0.2 - 0.8 U/kg) in Period 2 administered subcutaneously (SC).
11132852|NCT01771250|FG001|Participant Flow|Insulin Glargine Then Insulin Peglispro|Participants took a stable dose of insulin glargine (0.2 - 0.8 U/kg) in Period 1 and then insulin peglispro (0.2 - 0.8 U/kg) in Period 2 administered subcutaneously (SC).
11132853|NCT01771250|OG000|Outcome|Insulin Peglispro|Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
11132854|NCT01771250|OG001|Outcome|Insulin Glargine|Participants took a stable dose of Insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
11132855|NCT01771250|EG000|Reported Event|Insulin Peglispro|Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
11132856|NCT01771250|EG001|Reported Event|Insulin Glargine|Participants took a stable dose of Insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
11132857|NCT01771627|BG000|Baseline|Arm I (Varenicline)|"Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.~varenicline: Given PO"
11132858|NCT01771627|BG001|Baseline|Arm II (Nicotine Patch)|"Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.~nicotine patch"
11132859|NCT01771627|BG002|Baseline|Total|Total of all reporting groups
11132860|NCT01771627|FG000|Participant Flow|Arm I (Varenicline)|"Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.~varenicline: Given PO"
11132861|NCT01771627|FG001|Participant Flow|Arm II (Nicotine Patch)|"Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.~nicotine patch"
11132862|NCT01771627|OG000|Outcome|Arm I (Varenicline)|"Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.~varenicline: Given PO"
11132863|NCT01771627|OG001|Outcome|Arm II (Nicotine Patch)|"Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.~nicotine patch"
11132864|NCT01771627|EG000|Reported Event|Arm I (Varenicline)|"Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.~varenicline: Given PO"
11132865|NCT01771627|EG001|Reported Event|Arm II (Nicotine Patch)|"Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.~nicotine patch"
11132866|NCT01771666|BG000|Baseline|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
11132867|NCT01771666|FG000|Participant Flow|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
11132868|NCT01771666|OG000|Outcome|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
11132869|NCT01771666|EG000|Reported Event|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
11132870|NCT01771731|BG000|Baseline|Cannabis First, Then Placebo|"Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.~Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5."
11132871|NCT01771731|BG001|Baseline|Placebo First, Then Cannabis|"Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.~Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5."
11132872|NCT01771731|BG002|Baseline|Total|Total of all reporting groups
11132873|NCT01771731|FG000|Participant Flow|Cannabis First, Then Placebo|This group received active THC:CBD cannabis during their first 5-day inpatient admission and placebo during the second admission.
11132874|NCT01771731|FG001|Participant Flow|Placebo First, Then Cannabis|This group received placebo cannabis during their first 5-day inpatient admission and THC:CBD cannabis during the second.
11132875|NCT01771731|OG000|Outcome|Cannabis|Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
11132876|NCT01771731|OG001|Outcome|Placebo|Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
11132877|NCT01771731|EG000|Reported Event|Cannabis|Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
11132878|NCT01771731|EG001|Reported Event|Placebo|Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
11132879|NCT01771809|BG000|Baseline|SHP647 75 mg|Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
11132880|NCT01771809|BG001|Baseline|SHP647 225 mg|Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
11132881|NCT01771809|BG002|Baseline|Total|Total of all reporting groups
11132882|NCT01771809|FG000|Participant Flow|SHP647 75 mg|Participants received 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
11132883|NCT01771809|FG001|Participant Flow|SHP647 225 mg|Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
11132884|NCT01771809|OG000|Outcome|SHP647 75 mg|Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
11132885|NCT01771809|OG001|Outcome|SHP647 225 mg|Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
11132886|NCT01771809|EG000|Reported Event|SHP647 75 mg|Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
11132887|NCT01771809|EG001|Reported Event|SHP647 225 mg|Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
11132888|NCT01771913|BG000|Baseline|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
11132889|NCT01771913|BG001|Baseline|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
11132890|NCT01771913|BG002|Baseline|Total|Total of all reporting groups
11132891|NCT01771913|FG000|Participant Flow|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
11132892|NCT01771913|FG001|Participant Flow|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
11149587|NCT01871545|OG001|Outcome|Healthy Participant|Healthy control participants
11149588|NCT01871545|OG000|Outcome|Hepatocellular Carcinoma (HCC) at 6 Weeks|Participants with hepatocellular carcinoma (HCC) looking at 25 lesions
11132893|NCT01771913|OG000|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
11132894|NCT01771913|OG001|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
11132895|NCT01771913|EG000|Reported Event|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
11132896|NCT01771913|EG001|Reported Event|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
11132897|NCT01771952|BG000|Baseline|Synvisc-One™|"Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study."
11132898|NCT01771952|BG001|Baseline|Sham Treatment|"Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection.~Sham Treatment: A single needle stick without arthrocentesis or injection."
11132899|NCT01771952|BG002|Baseline|Total|Total of all reporting groups
11132900|NCT01771952|FG000|Participant Flow|Synvisc-One™|"Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study."
11132901|NCT01771952|FG001|Participant Flow|Sham Treatment|"Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection.~Sham Treatment: A single needle stick without arthrocentesis or injection."
10849122|NCT00294398|BG001|Baseline|ICS Prescription + Standard ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
11132902|NCT01771952|OG000|Outcome|Synvisc-One™|"Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study."
11132903|NCT01771952|OG001|Outcome|Sham Treatment|"Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection.~Sham Treatment: A single needle stick without arthrocentesis or injection."
11132904|NCT01771952|EG000|Reported Event|Synvisc-One™|"Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study."
11132905|NCT01771952|EG001|Reported Event|Sham Treatment|"Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection.~Sham Treatment: A single needle stick without arthrocentesis or injection."
11132906|NCT01771965|BG000|Baseline|Usual Care|No intervention.
11149589|NCT01871545|OG001|Outcome|Hepatocellular Carcinoma (HCC) at 6-12 Months|Participants with hepatocellular carcinoma (HCC) looking at 18 lesions
11149590|NCT01871545|EG000|Reported Event|Healthy Participant|Healthy control participants
11132907|NCT01771965|BG001|Baseline|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone~CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
11132908|NCT01771965|BG002|Baseline|Total|Total of all reporting groups
11132909|NCT01771965|FG000|Participant Flow|Usual Care|No intervention.
11132910|NCT01771965|FG001|Participant Flow|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone~CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
11132911|NCT01771965|OG000|Outcome|Usual Care|No intervention.
11132912|NCT01771965|OG001|Outcome|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone~CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
11132913|NCT01771965|EG000|Reported Event|Usual Care|No intervention.
11132914|NCT01771965|EG001|Reported Event|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone~CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
11132915|NCT01771991|BG000|Baseline|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
11132916|NCT01771991|BG001|Baseline|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
11132917|NCT01771991|BG002|Baseline|Total|Total of all reporting groups
11132918|NCT01771991|FG000|Participant Flow|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
11132919|NCT01771991|FG001|Participant Flow|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
11132920|NCT01771991|OG000|Outcome|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
11132921|NCT01771991|OG001|Outcome|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
11132922|NCT01771991|OG000|Outcome|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to applying Topical Sodermix Dismutase in the form of Sodermix(SOD) to the area of neck skin fibrosis twice a day for 12 weeks.~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
11132923|NCT01771991|EG000|Reported Event|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
11132924|NCT01771991|EG001|Reported Event|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
11132925|NCT01772134|BG000|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
10849123|NCT00294398|BG002|Baseline|Total|Total of all reporting groups
11132926|NCT01772134|BG001|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132927|NCT01772134|BG002|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132928|NCT01772134|BG003|Baseline|Total|Total of all reporting groups
11132929|NCT01772134|FG000|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and fluticasone propionate and salmeterol (FSC) 250/50 micrograms (µg) twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132930|NCT01772134|FG001|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132931|NCT01772134|FG002|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132932|NCT01772134|OG000|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132933|NCT01772134|OG001|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132934|NCT01772134|OG002|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132935|NCT01772134|EG000|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132936|NCT01772134|EG001|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132937|NCT01772134|EG002|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132938|NCT01772147|BG000|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132939|NCT01772147|BG001|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132940|NCT01772147|BG002|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132941|NCT01772147|BG003|Baseline|Total|Total of all reporting groups
11132942|NCT01772147|FG000|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and FSC 250/50 µg twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132943|NCT01772147|FG001|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
10887359|NCT00500149|FG000|Participant Flow|Vyvanse First|Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention
11132944|NCT01772147|FG002|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132945|NCT01772147|OG000|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132946|NCT01772147|OG001|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132947|NCT01772147|OG002|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132948|NCT01772147|EG000|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132949|NCT01772147|EG001|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132950|NCT01772147|EG002|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
11132951|NCT01772160|BG000|Baseline|Herpes Zoster Group|Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
11132952|NCT01772160|FG000|Participant Flow|Herpes Zoster Group|Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
11132953|NCT01772160|OG000|Outcome|Herpes Zoster Group|Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
11132954|NCT01772160|EG000|Reported Event|Herpes Zoster Group|Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
11149591|NCT01871545|EG001|Reported Event|SubStudy 1|Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls
11149592|NCT01871545|EG002|Reported Event|SubStudy 2|Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
11132955|NCT01772316|BG000|Baseline|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
11132956|NCT01772316|FG000|Participant Flow|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 milligram (mg) given as 0.9 milliliter (mL) of a 180 milligram per milliliter (mg/mL) solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by subcutaneous (SC) injection and as a single fixed dose irrespective of body weight.
11132957|NCT01772316|OG000|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
11132958|NCT01772316|EG000|Reported Event|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
11132959|NCT01772368|BG000|Baseline|All Participants|All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.
11132960|NCT01772368|FG000|Participant Flow|All Participants|All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.
11132961|NCT01772368|OG000|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
11132962|NCT01772368|OG001|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
11132963|NCT01772368|OG002|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
11132964|NCT01772368|OG003|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
11132965|NCT01772368|OG004|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
11132966|NCT01772368|OG005|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
11132967|NCT01772368|OG006|Outcome|Fp MDPI 50 mcg X 2 BID|Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
11132968|NCT01772368|EG000|Reported Event|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
11132969|NCT01772368|EG001|Reported Event|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
11132970|NCT01772368|EG002|Reported Event|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
11132971|NCT01772368|EG003|Reported Event|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
11132972|NCT01772368|EG004|Reported Event|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
11132973|NCT01772368|EG005|Reported Event|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
11132974|NCT01772368|EG006|Reported Event|Fp MDPI 50 mcg X 2 BID|Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
11132975|NCT01772537|BG000|Baseline|Stent Graft Repair Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
11132976|NCT01772537|BG001|Baseline|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
11132977|NCT01772537|BG002|Baseline|Open Repair|These patients received no intervention, just standard of care.
11132978|NCT01772537|BG003|Baseline|Total|Total of all reporting groups
11132979|NCT01772537|FG000|Participant Flow|Stent Graft Repair Propofol|"Patients have a stent graft repair receiving intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
11132980|NCT01772537|FG001|Participant Flow|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
11132981|NCT01772537|FG002|Participant Flow|Open Repair|These patient will receive no intervention, just standard of care.
11132982|NCT01772537|OG000|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
11132983|NCT01772537|OG001|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
11132984|NCT01772537|OG000|Outcome|Delirum Status Post Open Thoracoabdominal Aneurysm Repair|These are participants that received open thoracoabdominal aneurysm repair instead of aneurysm stenting.
11132985|NCT01772537|OG001|Outcome|Delerium Staus Post Stenting of Aneuryms Propofol|These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Propofol as their primary anesthetic.
11132986|NCT01772537|OG002|Outcome|Stent Graft Aneurysm Repair Isoflurane|These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Isoflurane as their primary anesthetic.
11132987|NCT01772537|EG000|Reported Event|Stent Graft Repair Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
11132988|NCT01772537|EG001|Reported Event|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
11132989|NCT01772537|EG002|Reported Event|Open Thoracoabdominal Aneurysm Repair|These are patients that received open thoracabdominal aneurysm repair instead of aneurysm stenting.
11132990|NCT01772550|BG000|Baseline|20 GA BD Nexiva Diffusics - Randomized|
11132991|NCT01772550|BG001|Baseline|18 GA Conventional Catheter - Randomized|
11132992|NCT01772550|BG002|Baseline|20 GA BD Nexiva Diffusics - Nonrandomized|
11132993|NCT01772550|BG003|Baseline|Total|Total of all reporting groups
11132994|NCT01772550|FG000|Participant Flow|20 GA BD Nexiva Diffusics - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20 GA fenestrated BD Nexiva Diffusics single port IV catheter
11132995|NCT01772550|FG001|Participant Flow|18 GA Conventional Catheter - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the non-fenestrated 18GA x 1.25 inch Smiths Medical Jelco IV catheter
11132996|NCT01772550|FG002|Participant Flow|20 GA BD Nexiva Diffusics - Nonrandomized|Subjects whose veins are not suitable for an 18GA IV catheter will be assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20GA fenestrated BD Nexiva Diffusics single port IV catheter
11132997|NCT01772550|OG000|Outcome|20 GA BD Nexiva Diffusics - Randomized|
11132998|NCT01772550|OG001|Outcome|18 GA Conventional Catheter - Randomized|
11132999|NCT01772550|OG002|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
11133000|NCT01772550|EG000|Reported Event|20 GA BD Nexiva Diffusics - Randomized|
11133001|NCT01772550|EG001|Reported Event|18 GA Conventional Catheter - Randomized|
11133002|NCT01772550|EG002|Reported Event|20 GA BD Nexiva Diffusics - Nonrandomized|
11149593|NCT01871558|BG000|Baseline|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
11149594|NCT01871558|BG001|Baseline|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
11149595|NCT01871558|BG002|Baseline|Total|Total of all reporting groups
11149596|NCT01871558|FG000|Participant Flow|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
11149597|NCT01871558|FG001|Participant Flow|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
11149598|NCT01871558|OG000|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
11149599|NCT01871558|OG001|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
11149600|NCT01871558|EG000|Reported Event|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
11149601|NCT01871558|EG001|Reported Event|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
11149602|NCT01871805|BG000|Baseline|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149603|NCT01871805|BG001|Baseline|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149604|NCT01871805|BG002|Baseline|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149605|NCT01871805|BG003|Baseline|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149606|NCT01871805|BG004|Baseline|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149607|NCT01871805|BG005|Baseline|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149608|NCT01871805|BG006|Baseline|Total|Total of all reporting groups
11149609|NCT01871805|FG000|Participant Flow|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 milligrams (mg) alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg twice daily (BID) dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149610|NCT01871805|FG001|Participant Flow|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149611|NCT01871805|FG002|Participant Flow|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11133003|NCT01772576|BG000|Baseline|Reliance 4-Front|"Single arm, all patients will be implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation should be from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
11133004|NCT01772576|FG000|Participant Flow|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
11133005|NCT01772576|OG000|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
11133006|NCT01772576|EG000|Reported Event|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
11133007|NCT01772654|BG000|Baseline|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
11133008|NCT01772654|BG001|Baseline|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
11133009|NCT01772654|BG002|Baseline|Total|Total of all reporting groups
11133010|NCT01772654|FG000|Participant Flow|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
10849124|NCT00294398|FG000|Participant Flow|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and were provided a home nebulizer if needed.
11133011|NCT01772654|FG001|Participant Flow|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
11133012|NCT01772654|OG000|Outcome|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
11133013|NCT01772654|OG001|Outcome|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood. This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
11133014|NCT01772654|EG000|Reported Event|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
11133015|NCT01772654|EG001|Reported Event|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
11133016|NCT01772693|BG000|Baseline|ExAblate Transcranial MRgFUS|"ExAblate Transcranial MR guided Focused Ultrasound~ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound"
11133017|NCT01772693|BG001|Baseline|Sham ExAblate Transcranial MRgFUS|"Sham treatment with ExAblate MR guided Focused Ultrasound~Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound"
11133018|NCT01772693|BG002|Baseline|Total|Total of all reporting groups
11133019|NCT01772693|FG000|Participant Flow|ExAblate Transcranial MRgFUS|"ExAblate Transcranial MR guided Focused Ultrasound~ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound"
11133020|NCT01772693|FG001|Participant Flow|Sham ExAblate Transcranial MRgFUS|"Sham treatment with ExAblate MR guided Focused Ultrasound~Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound"
11133021|NCT01772693|OG000|Outcome|ExAblate Transcranial MRgFUS|"ExAblate Transcranial MR guided Focused Ultrasound~ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound"
11133022|NCT01772693|OG001|Outcome|Sham ExAblate Transcranial MRgFUS|"Sham treatment with ExAblate MR guided Focused Ultrasound~Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound"
11133023|NCT01772693|EG000|Reported Event|ExAblate Transcranial MRgFUS|"ExAblate Transcranial MR guided Focused Ultrasound~ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound"
11133024|NCT01772693|EG001|Reported Event|Sham ExAblate Transcranial MRgFUS|"Sham treatment with ExAblate MR guided Focused Ultrasound~Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound"
11133025|NCT01772758|BG000|Baseline|Protocol 1: AOC|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Vitamin E, 600IU: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Alpha Lipoic Acid, 600mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
11133026|NCT01772758|BG001|Baseline|Protocol 2: BH4 (5mg)|"measurements at baseline and 3 hours following the single dose of 5mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
11133027|NCT01772758|BG002|Baseline|Protocol 2: BH4 (20mg)|"measurements at baseline and 3 hours following the single dose of 20mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
11133028|NCT01772758|BG003|Baseline|Healthy Controls|baseline measurements were done with no intervention
11133029|NCT01772758|BG004|Baseline|Total|Total of all reporting groups
11133030|NCT01772758|FG000|Participant Flow|Protocol 1: AOC|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Vitamin E, 600IU: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Alpha Lipoic Acid, 600mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
11133031|NCT01772758|FG001|Participant Flow|Protocol 2: BH4 (5mg)|"measurements at baseline and 3 hours following the single dose of 5mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
11133032|NCT01772758|FG002|Participant Flow|Protocol 2: BH4 (20mg)|"measurements at baseline and 3 hours following the single dose of 20mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
11133033|NCT01772758|FG003|Participant Flow|Healthy Controls|measurements were done with no intervention
11133034|NCT01772758|OG000|Outcome|Protocol 1: AOC|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Vitamin E, 600IU: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Alpha Lipoic Acid, 600mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
11133035|NCT01772758|OG001|Outcome|Protocol 2: BH4 (5mg)|"measurements at baseline and 3 hours following the single dose of 5mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
11133036|NCT01772758|OG002|Outcome|Protocol 2: BH4 (20mg)|"measurements at baseline and 3 hours following the single dose of 20mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
11133037|NCT01772758|OG003|Outcome|Healthy Controls|measurements were done with no intervention
11133038|NCT01772758|EG000|Reported Event|Antioxidant Cocktail: CF Patients|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Vitamin E, 600IU: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Alpha Lipoic Acid, 600mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
11133039|NCT01772758|EG001|Reported Event|Antioxidant Cocktail: Healthy Controls|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
11133040|NCT01772758|EG002|Reported Event|Tetrahydrobiopterin (BH4): 5mg|"measurements at baseline and 3 hours following the single dose of 5mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
11133041|NCT01772758|EG003|Reported Event|Tetrahydrobiopterin (BH4): 20mg|"measurements at baseline and 3 hours following the single dose of 20mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
11133042|NCT01772823|BG000|Baseline|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11133043|NCT01772823|BG001|Baseline|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11133044|NCT01772823|BG002|Baseline|Total|Total of all reporting groups
11133045|NCT01772823|FG000|Participant Flow|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11133046|NCT01772823|FG001|Participant Flow|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11133047|NCT01772823|OG000|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
11133048|NCT01772823|OG000|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11133049|NCT01772823|OG001|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11133050|NCT01772823|OG000|Outcome|On Prep|Remained on study agent
11133051|NCT01772823|OG001|Outcome|Off Prep|Prematurely discontinued from the study agent
11133052|NCT01772823|OG000|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
11133053|NCT01772823|OG001|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
11133054|NCT01772823|EG000|Reported Event|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11133055|NCT01772823|EG001|Reported Event|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
11133056|NCT01773070|BG000|Baseline|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
11133057|NCT01773070|FG000|Participant Flow|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic hepatitis C virus (HCV), followed for up to 3 years post-treatment.
11133058|NCT01773070|OG000|Outcome|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
11133059|NCT01773070|EG000|Reported Event|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
11133060|NCT01773109|BG000|Baseline|Etirinotecan Pegol|This Phase II, single-arm, open-label study is designed to investigate the efficacy and safety of etirinotecan pegol in patients with metastatic or recurrent NSCLC after failure of 2nd line therapy. Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Patients will be followed clinically every week for the first cycle with laboratory parameters and physical exam. Response will be determined with RECIST version 1.1 after 2 cycles of therapy. Patients with Stable disease (SD), partial response (PR) or complete response (CR) will continue on additional therapy for up to six cycles. In the absence of disease progression in subjects completing six full cycles, further treatment beyond cycle #6 will be left to the discretion of the treating physician and his/her staff. Patients with progressive disease will be taken off study and will be followed for overall survival.
11133061|NCT01773109|FG000|Participant Flow|Etirinotecan Pegol|145 mg/m2 will be administered as an IV infusion over a course of 90 minutes on Day 1 of a 21 day cycle
11133062|NCT01773109|OG000|Outcome|Etirinotecan Pegol|This Phase II, single-arm, open-label study is designed to investigate the efficacy and safety of etirinotecan pegol in patients with metastatic or recurrent NSCLC after failure of 2nd line therapy. Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Patients will be followed clinically every week for the first cycle with laboratory parameters and physical exam. Response will be determined with RECIST version 1.1 after 2 cycles of therapy. Patients with Stable disease (SD), partial response (PR) or complete response (CR) will continue on additional therapy for up to six cycles. In the absence of disease progression in subjects completing six full cycles, further treatment beyond cycle #6 will be left to the discretion of the treating physician and his/her staff. Patients with progressive disease will be taken off study and will be followed for overall survival.
11133063|NCT01773109|EG000|Reported Event|Etirinotecan Pegol|Etirinotecan pegol (NKTR-102): 145mg/m2 intravenously every 3 weeks
11133064|NCT01773122|BG000|Baseline|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133065|NCT01773122|BG001|Baseline|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133066|NCT01773122|BG002|Baseline|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133067|NCT01773122|BG003|Baseline|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
11133068|NCT01773122|BG004|Baseline|Total|Total of all reporting groups
11133069|NCT01773122|FG000|Participant Flow|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133070|NCT01773122|FG001|Participant Flow|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133071|NCT01773122|FG002|Participant Flow|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133072|NCT01773122|FG003|Participant Flow|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
11133073|NCT01773122|OG000|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133074|NCT01773122|OG001|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133075|NCT01773122|OG002|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133076|NCT01773122|OG003|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
11133077|NCT01773122|EG000|Reported Event|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133078|NCT01773122|EG001|Reported Event|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133079|NCT01773122|EG002|Reported Event|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
11133080|NCT01773122|EG003|Reported Event|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
11133081|NCT01773135|BG000|Baseline|Preterm Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.~this group delivered preterm (before 37 weeks of gestation)"
11133082|NCT01773135|BG001|Baseline|Full Term Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.~this group delivered full term (after 37 weeks of gestation)"
11133083|NCT01773135|BG002|Baseline|Total|Total of all reporting groups
11149612|NCT01871805|FG003|Participant Flow|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11133084|NCT01773135|FG000|Participant Flow|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.~then, collection of blood sample and tocolysis adminstration will be done~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
11133085|NCT01773135|OG000|Outcome|Preterm Group|group of patients who delivered before 37 weeks of gestation
11133086|NCT01773135|OG001|Outcome|Full Term Group|group of patients who delivered after 37 weeks of gestation
11133087|NCT01773135|EG000|Reported Event|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.~then, collection of blood sample and tocolysis adminstration will be done~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
11133088|NCT01773187|BG000|Baseline|Pacritinib|Pacritinib 400 mg QD
11133089|NCT01773187|BG001|Baseline|Best Available Therapy|BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
11133090|NCT01773187|BG002|Baseline|Total|Total of all reporting groups
11133091|NCT01773187|FG000|Participant Flow|Pacritinib|Pacritinib 400 mg QD
11133092|NCT01773187|FG001|Participant Flow|Best Available Therapy|BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
11133093|NCT01773187|OG000|Outcome|Pacritinib|Pacritinib 400 mg QD
11133094|NCT01773187|OG001|Outcome|Best Available Therapy|BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
11133095|NCT01773187|EG000|Reported Event|Pacritinib|Pacritinib 400 mg QD
11133096|NCT01773187|EG001|Reported Event|Best Available Therapy|BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
11133097|NCT01773226|BG000|Baseline|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
11133098|NCT01773226|FG000|Participant Flow|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
11133099|NCT01773226|OG000|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
11133100|NCT01773226|EG000|Reported Event|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
11133101|NCT01773291|BG000|Baseline|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
11133102|NCT01773291|BG001|Baseline|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
11133103|NCT01773291|BG002|Baseline|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture"
11133104|NCT01773291|BG003|Baseline|Total|Total of all reporting groups
11133105|NCT01773291|FG000|Participant Flow|Acupuncture|"acupuncture on Shuigou (GV26) and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
11133106|NCT01773291|FG001|Participant Flow|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
11133107|NCT01773291|FG002|Participant Flow|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
11133108|NCT01773291|OG000|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
11133109|NCT01773291|OG001|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
11133110|NCT01773291|OG002|Outcome|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
11133111|NCT01773291|OG002|Outcome|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture"
11133112|NCT01773291|EG000|Reported Event|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
11133113|NCT01773291|EG001|Reported Event|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
11133114|NCT01773291|EG002|Reported Event|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
11133115|NCT01773421|BG000|Baseline|Treatment Phase Part A: E7820 50 mg Fed+ E7820 50 mg Fasted|Participants received E7820 50 mg, tablet, orally, under fed condition on Day 1, followed by E7820 50 mg, tablet, orally, under fasted condition on Day 8. A washout period of 7 days was maintained between the doses.
11133116|NCT01773421|BG001|Baseline|Treatment Phase Part A: E7820 50 mg Fasted + E7820 50 mg Fed|Participants received E7820 50 mg, tablet, orally, under fasted condition on Day 1, followed by E7820 50 mg, tablet, orally, under fed condition on Day 8. A washout period of 7 days was maintained between the doses.
11133117|NCT01773421|BG002|Baseline|Treatment Phase Part B: E7820 50 mg|Participants received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation.
11133118|NCT01773421|BG003|Baseline|Treatment Phase Part B: E7820 60 mg|Participants received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation.
11133119|NCT01773421|BG004|Baseline|Total|Total of all reporting groups
11133120|NCT01773421|FG000|Participant Flow|Treatment Phase Part A: E7820 50 mg Fed+ E7820 50 mg Fasted|Participants received E7820 50 milligram (mg), tablet, orally, under fed condition on Day 1, followed by E7820 50 mg, tablet, orally, under fasted condition on Day 8. A washout period of 7 days was maintained between the doses.
11133121|NCT01773421|FG001|Participant Flow|Treatment Phase Part A: E7820 50 mg Fasted + E7820 50 mg Fed|Participants received E7820 50 mg, tablet, orally, under fasted condition on Day 1, followed by E7820 50 mg, tablet, orally, under fed condition on Day 8. A washout period of 7 days was maintained between the doses.
11133122|NCT01773421|FG002|Participant Flow|Treatment Phase Part B: E7820 50 mg|Participants received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation.
11133123|NCT01773421|FG003|Participant Flow|Treatment Phase Part B: E7820 60 mg|Participants received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation.
11133124|NCT01773421|FG004|Participant Flow|Extension Phase Part A: E7820 100 mg|Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 100 mg, once daily, tablet, orally, under fasted condition, during 28-day cycle until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133125|NCT01773421|FG005|Participant Flow|Extension Phase Part B: E7820 50 mg|Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133126|NCT01773421|FG006|Participant Flow|Extension Phase Part B: E7820 60 mg|Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development. No participants from the treatment phase Part B: E7820 60 mg entered the extension phase.
11133127|NCT01773421|OG000|Outcome|Treatment Phase Part A: E7820 50 mg Fed|Participants received E7820 50 mg, tablet, orally, under fed condition, once on Day 1 or Day 8 in treatment phase.
11133128|NCT01773421|OG001|Outcome|Treatment Phase Part A: E7820 50 mg Fasted|Participants received E7820 50 mg, tablet, orally, under fasted condition, once on Day 1 or Day 8 in treatment phase.
11133129|NCT01773421|OG000|Outcome|Treatment Phase Part B: All Participants|Participants received E7820 50 mg or 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation.
11133130|NCT01773421|OG000|Outcome|Extension Phase Part A: E7820 100 mg|Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 100 mg, once daily, tablet, orally, under fasted condition, during 28-day cycle until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133131|NCT01773421|OG001|Outcome|Treatment and Extension Phase Part B: E7820 50 mg|Participants received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation. Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133132|NCT01773421|OG002|Outcome|Treatment and Extension Phase Part B: E7820 60 mg|Participants received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation. Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133133|NCT01773421|OG002|Outcome|Extension Phase Part A: E7820 100 mg|Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 100 mg, once daily, tablet, orally, under fasted condition, during 28-day cycle until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133134|NCT01773421|OG003|Outcome|Treatment and Extension Phase Part B: E7820 50 mg|Participants received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation. Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11149613|NCT01871805|FG004|Participant Flow|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11133135|NCT01773421|OG004|Outcome|Treatment and Extension Phase Part B: E7820 60 mg|Participants received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation. Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133136|NCT01773421|EG000|Reported Event|Treatment Phase Part A: E7820 50 mg Fed|Participants received E7820 50 mg, tablet, orally, under fed condition, once on Day 1 or Day 8 in treatment phase.
11133137|NCT01773421|EG001|Reported Event|Treatment Phase Part A: E7820 50 mg Fasted|Participants received E7820 50 mg, tablet, orally, under fasted condition, once on Day 1 or Day 8 in treatment phase.
11133138|NCT01773421|EG002|Reported Event|Extension Phase Part A: E7820 100 mg|Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 100 mg, once daily, tablet, orally, under fasted condition, during 28-day cycle until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133139|NCT01773421|EG003|Reported Event|Treatment and Extension Phase Part B: E7820 50 mg|Participants received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation. Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 50 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133140|NCT01773421|EG004|Reported Event|Treatment and Extension Phase Part B: E7820 60 mg|Participants received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles or early discontinuation. Participants at the end of treatment phase (who received study drug at the time of data cutoff for the primary analysis) moved on to extension phase and received E7820 60 mg, BID, tablet, orally, during each 28-day cycle for up to 6 cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor discontinuation of E7820 development.
11133141|NCT01773473|BG000|Baseline|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
11133142|NCT01773473|BG001|Baseline|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
11133143|NCT01773473|BG002|Baseline|Total|Total of all reporting groups
11133144|NCT01773473|FG000|Participant Flow|Insulin Lispro Mix25|Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
11133145|NCT01773473|FG001|Participant Flow|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
11133146|NCT01773473|OG000|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
11133147|NCT01773473|OG001|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
11133148|NCT01773473|EG000|Reported Event|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
11133149|NCT01773473|EG001|Reported Event|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
11133150|NCT01773889|BG000|Baseline|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
11133151|NCT01773889|FG000|Participant Flow|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
11133152|NCT01773889|OG000|Outcome|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
11133153|NCT01773889|EG000|Reported Event|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
11133154|NCT01773954|BG000|Baseline|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
11133155|NCT01773954|FG000|Participant Flow|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
11133156|NCT01773954|OG000|Outcome|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
11133157|NCT01773954|EG000|Reported Event|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
11133158|NCT01773967|BG000|Baseline|Lactobacillus Rhamnosus GG|"LGG 10^10 cfu PO bid x 5 days~LGG: LGG 10^10 cfu PO BID X 5 days"
11133159|NCT01773967|BG001|Baseline|Placebo|"micro-crystalline cellulose PO bid x 5 days~micro-crystalline cellulose: 1 capsule PO bid x 5 days"
11133160|NCT01773967|BG002|Baseline|Total|Total of all reporting groups
11133161|NCT01773967|FG000|Participant Flow|Lactobacillus Rhamnosus GG|"LGG 10^10 cfu PO bid x 5 days~LGG: LGG 10^10 cfu PO BID X 5 days"
11133162|NCT01773967|FG001|Participant Flow|Placebo|"micro-crystalline cellulose PO bid x 5 days~micro-crystalline cellulose: 1 capsule PO bid x 5 days"
11133163|NCT01773967|OG000|Outcome|Lactobacillus Rhamnosus GG|"LGG 10^10 cfu PO bid x 5 days~LGG: LGG 10^10 cfu PO BID X 5 days"
11133164|NCT01773967|OG001|Outcome|Placebo|"micro-crystalline cellulose PO bid x 5 days~micro-crystalline cellulose: 1 capsule PO bid x 5 days"
11133165|NCT01773967|EG000|Reported Event|Lactobacillus Rhamnosus GG|"LGG 10^10 cfu PO bid x 5 days~LGG: LGG 10^10 cfu PO BID X 5 days"
11133166|NCT01773967|EG001|Reported Event|Placebo|"micro-crystalline cellulose PO bid x 5 days~micro-crystalline cellulose: 1 capsule PO bid x 5 days"
11133167|NCT01773993|BG000|Baseline|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11133168|NCT01773993|FG000|Participant Flow|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11133169|NCT01773993|OG000|Outcome|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11133170|NCT01773993|EG000|Reported Event|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11133171|NCT01774045|BG000|Baseline|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~PDC-1421"
11133172|NCT01774045|BG001|Baseline|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~Placebo"
11133173|NCT01774045|BG002|Baseline|Total|Total of all reporting groups
11133174|NCT01774045|FG000|Participant Flow|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~PDC-1421"
11133175|NCT01774045|FG001|Participant Flow|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~Placebo"
11133176|NCT01774045|OG000|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
11133177|NCT01774045|OG001|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
11133178|NCT01774045|OG001|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
11133179|NCT01774045|EG000|Reported Event|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
11133180|NCT01774045|EG001|Reported Event|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
11133181|NCT01774084|BG000|Baseline|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
11133182|NCT01774084|BG001|Baseline|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
11133183|NCT01774084|BG002|Baseline|Total|Total of all reporting groups
11133184|NCT01774084|FG000|Participant Flow|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
11133185|NCT01774084|FG001|Participant Flow|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
11133186|NCT01774084|OG000|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
11133187|NCT01774084|OG001|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
11133188|NCT01774084|EG000|Reported Event|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
11133189|NCT01774084|EG001|Reported Event|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
11133190|NCT01774097|BG000|Baseline|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
11133191|NCT01774097|BG001|Baseline|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
11133192|NCT01774097|BG002|Baseline|Total|Total of all reporting groups
11133193|NCT01774097|FG000|Participant Flow|ALDHbr|"Participants will receive ALDHbr via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh"
11133194|NCT01774097|FG001|Participant Flow|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
11133195|NCT01774097|OG000|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
11133196|NCT01774097|OG001|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
11133197|NCT01774097|OG000|Outcome|ALDHbr|Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh
11133198|NCT01774097|OG000|Outcome|ALDHbr|"Participants will receive ALDHbr via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh"
11133199|NCT01774097|EG000|Reported Event|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
11133200|NCT01774097|EG001|Reported Event|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
11149614|NCT01871805|FG005|Participant Flow|Alectinib 600 mg (Fed): Phase II|Participants received 150 mg alectinib capsules orally to make a dose of 600 mg BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11133201|NCT01774110|BG000|Baseline|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.~Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
11133202|NCT01774110|FG000|Participant Flow|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.~Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
11133203|NCT01774110|OG000|Outcome|ESTT|
11133204|NCT01774110|OG000|Outcome|Early Standardized Treadmill Training|
11133205|NCT01774110|EG000|Reported Event|ESTT|early standardized treadmill training
11133206|NCT01774149|BG000|Baseline|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
11133207|NCT01774149|BG001|Baseline|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
11133208|NCT01774149|BG002|Baseline|Total|Total of all reporting groups
11133209|NCT01774149|FG000|Participant Flow|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
11133210|NCT01774149|FG001|Participant Flow|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
11133211|NCT01774149|OG000|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
11133212|NCT01774149|OG001|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
11133213|NCT01774149|EG000|Reported Event|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
11133214|NCT01774149|EG001|Reported Event|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
10849125|NCT00294398|FG001|Participant Flow|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
11133215|NCT01774305|BG000|Baseline|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
11133216|NCT01774305|BG001|Baseline|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
11133217|NCT01774305|BG002|Baseline|Total|Total of all reporting groups
11133218|NCT01774305|FG000|Participant Flow|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
11133219|NCT01774305|FG001|Participant Flow|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
11133220|NCT01774305|OG000|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
11133221|NCT01774305|OG001|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
11133222|NCT01774305|EG000|Reported Event|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
11133223|NCT01774305|EG001|Reported Event|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
11133224|NCT01774344|BG000|Baseline|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care (BSC).
11133225|NCT01774344|BG001|Baseline|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
11133226|NCT01774344|BG002|Baseline|Total|Total of all reporting groups
11133227|NCT01774344|FG000|Participant Flow|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
11133228|NCT01774344|FG001|Participant Flow|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
11133229|NCT01774344|OG000|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
11133230|NCT01774344|OG001|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
11133231|NCT01774344|EG000|Reported Event|Placebo|Description: Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care(BSC).
11133232|NCT01774344|EG001|Reported Event|Regorafenib (Stivarga, BAY73-4506)|Description: Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
11133233|NCT01774591|BG000|Baseline|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
11133234|NCT01774591|BG001|Baseline|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
11133235|NCT01774591|BG002|Baseline|Total|Total of all reporting groups
11133236|NCT01774591|FG000|Participant Flow|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
11133237|NCT01774591|FG001|Participant Flow|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
11133238|NCT01774591|OG000|Outcome|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
11133239|NCT01774591|OG001|Outcome|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
11133240|NCT01774591|EG000|Reported Event|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
11133241|NCT01774591|EG001|Reported Event|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
11133242|NCT01774604|BG000|Baseline|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
11133243|NCT01774604|BG001|Baseline|Placebo|"Placebo suppositories (#2)~Placebo"
11133244|NCT01774604|BG002|Baseline|Total|Total of all reporting groups
11133245|NCT01774604|FG000|Participant Flow|Indomethacin|"Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
11133246|NCT01774604|FG001|Participant Flow|Placebo|"Placebo suppositories (#2)~Placebo"
11133247|NCT01774604|OG000|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
11133248|NCT01774604|OG001|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
11133249|NCT01774604|EG000|Reported Event|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
11133250|NCT01774604|EG001|Reported Event|Placebo|"Placebo suppositories (#2)~Placebo"
11133251|NCT01774760|BG000|Baseline|18F-EF5 PET/CT Scan|10 pts with HNSCC. See Table 1 (p. 163) in Eur J Nucl Med Mol Imaging 2018;45:161-169 https://doi.org/10.1007/s00259-017-3857-3
11133252|NCT01774760|FG000|Participant Flow|18F-EF5 PET/CT Scan|"18F-EF5~Pretreatment PET/CT-scan (performed two times)"
11133253|NCT01774760|OG000|Outcome|Patients With Stage III-IV Head and Neck Cancer|Patients undergoing radiation treatment planning who receive pretreatment PET/CT-scan twice within 1 week as an experimental procedure
11133254|NCT01774760|EG000|Reported Event|18F-EF5 PET/CT Scan|"18F-EF5~Pretreatment PET/CT-scan (performed two times)"
11133255|NCT01774786|BG000|Baseline|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
11133256|NCT01774786|BG001|Baseline|Placebo + Trastuzumab + Chemotherapy|Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
11133257|NCT01774786|BG002|Baseline|Total|Total of all reporting groups
11133258|NCT01774786|FG000|Participant Flow|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
11133259|NCT01774786|FG001|Participant Flow|Placebo + Trastuzumab + Chemotherapy|Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
11133260|NCT01774786|OG000|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
11133261|NCT01774786|OG001|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
11133262|NCT01774786|EG000|Reported Event|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
11149615|NCT01871805|OG000|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11133263|NCT01774786|EG001|Reported Event|Placebo + Trastuzumab + Chemotherapy|Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
11133264|NCT01774799|BG000|Baseline|Advance Care Planning Intervention Residents|Residents with advanced dementia in intervention group
11133265|NCT01774799|BG001|Baseline|Usual Care (Control Group) Residents|Residents with advanced dementia in control group
11133266|NCT01774799|BG002|Baseline|Advance Care Planning Intervention Proxies|Proxies of residents with advanced dementia in intervention group
11133267|NCT01774799|BG003|Baseline|Usual Care (Control Group) Proxies|Proxies of residents with advanced dementia in control group
11133268|NCT01774799|BG004|Baseline|Total|Total of all reporting groups
11133269|NCT01774799|FG000|Participant Flow|Advance Care Planning Intervention Residents|"At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form.~Advance care planning intervention"
11133270|NCT01774799|FG001|Participant Flow|Usual Care (Control) Residents|"Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home.~Control group"
11133271|NCT01774799|FG002|Participant Flow|Advance Care Planning Intervention Proxies|At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form.
11133272|NCT01774799|FG003|Participant Flow|Usual Care (Control) Proxies|"Proxies in control nursing homes experienced he usual advance care planning that occurs in their nursing home.~Control group"
11133273|NCT01774799|OG000|Outcome|Advance Care Planning Intervention|"At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form.~Advance care planning intervention"
11133274|NCT01774799|OG001|Outcome|Usual Care|"Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home.~Control group"
11133275|NCT01774799|EG000|Reported Event|Advance Care Planning Intervention|"Adverse events were only monitored in the health care proxies who viewed the video~Advance care planning intervention"
11133276|NCT01774799|EG001|Reported Event|Usual Care|"Adverse event monitoring was no applicable the proxies in the usual care group as they did not watch the video, and the only adverse event monitored in the trial related to reactions to watching the video~Control group"
11133277|NCT01774851|BG000|Baseline|Control Group|Trastuzumab + paclitaxel
11133278|NCT01774851|BG001|Baseline|Experimental Group|MM-111 + trastuzumab + paclitaxel
10849126|NCT00294398|OG000|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
11133279|NCT01774851|BG002|Baseline|Total|Total of all reporting groups
11133280|NCT01774851|FG000|Participant Flow|Control Group|Paclitaxel + Trastuzumab
11133281|NCT01774851|FG001|Participant Flow|Experimental Group|MM-111 + trastuzumab + paclitaxel
11133282|NCT01774851|OG000|Outcome|Control Group|trastuzumab + paclitaxel
11133283|NCT01774851|OG001|Outcome|Experimental Group|MM-111 + trastuzumab + paclitaxel
11133284|NCT01774851|EG000|Reported Event|Control Group|trastuzumab + paclitaxel
11133285|NCT01774851|EG001|Reported Event|Experimental Group|MM-111 + trastuzumab + paclitaxel
11133286|NCT01774903|BG000|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133287|NCT01774903|FG000|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133288|NCT01774903|OG000|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133289|NCT01774903|OG000|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133290|NCT01774903|EG000|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133291|NCT01774929|BG000|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133292|NCT01774929|FG000|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133293|NCT01774929|OG000|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133294|NCT01774929|EG000|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
11133295|NCT01774968|BG000|Baseline|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
11133296|NCT01774968|BG001|Baseline|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
11133297|NCT01774968|BG002|Baseline|Total|Total of all reporting groups
11133298|NCT01774968|FG000|Participant Flow|Human Regular U-500 Insulin TID|Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
11133299|NCT01774968|FG001|Participant Flow|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
11133300|NCT01774968|OG000|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
11133301|NCT01774968|OG001|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
11133302|NCT01774968|EG000|Reported Event|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
11133303|NCT01774968|EG001|Reported Event|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
11133304|NCT01774981|BG000|Baseline|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
11133305|NCT01774981|BG001|Baseline|10 mg LY3016859 (Part A)|Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133306|NCT01774981|BG002|Baseline|100 mg LY3016859 (Part A)|Part A:100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133307|NCT01774981|BG003|Baseline|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133308|NCT01774981|BG004|Baseline|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133309|NCT01774981|BG005|Baseline|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133310|NCT01774981|BG006|Baseline|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133311|NCT01774981|BG007|Baseline|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133312|NCT01774981|BG008|Baseline|Total|Total of all reporting groups
11133313|NCT01774981|FG000|Participant Flow|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
11133314|NCT01774981|FG001|Participant Flow|10 mg LY3016859 (Part A)|Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133315|NCT01774981|FG002|Participant Flow|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133316|NCT01774981|FG003|Participant Flow|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133317|NCT01774981|FG004|Participant Flow|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133318|NCT01774981|FG005|Participant Flow|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133319|NCT01774981|FG006|Participant Flow|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133320|NCT01774981|FG007|Participant Flow|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133321|NCT01774981|OG000|Outcome|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133322|NCT01774981|OG001|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133323|NCT01774981|OG002|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133324|NCT01774981|OG003|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133325|NCT01774981|OG000|Outcome|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
11133326|NCT01774981|OG001|Outcome|10 mg LY3016859 (Part A)|Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133327|NCT01774981|OG002|Outcome|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133328|NCT01774981|OG003|Outcome|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133329|NCT01774981|OG004|Outcome|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133330|NCT01774981|OG005|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133331|NCT01774981|OG006|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133332|NCT01774981|OG007|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133333|NCT01774981|OG000|Outcome|Placebo (Part B)|Part B:Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133334|NCT01774981|EG000|Reported Event|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
11133335|NCT01774981|EG001|Reported Event|10 mg LY3016859 (Part A)|Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133336|NCT01774981|EG002|Reported Event|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133337|NCT01774981|EG003|Reported Event|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
11133338|NCT01774981|EG004|Reported Event|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133339|NCT01774981|EG005|Reported Event|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133340|NCT01774981|EG006|Reported Event|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133341|NCT01774981|EG007|Reported Event|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
11133342|NCT01775124|BG000|Baseline|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
11133343|NCT01775124|BG001|Baseline|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
11133344|NCT01775124|BG002|Baseline|Total|Total of all reporting groups
11133345|NCT01775124|FG000|Participant Flow|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
11133346|NCT01775124|FG001|Participant Flow|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
11133347|NCT01775124|OG000|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
11133348|NCT01775124|OG001|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
11133349|NCT01775124|OG000|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
11133350|NCT01775124|EG000|Reported Event|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
11133351|NCT01775124|EG001|Reported Event|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
11133352|NCT01775137|BG000|Baseline|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
11133353|NCT01775137|FG000|Participant Flow|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
11133354|NCT01775137|OG000|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
11133355|NCT01775137|OG000|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
11133356|NCT01775137|EG000|Reported Event|Core|Eligible participants were assigned to four capsules of TIP at 28 mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose = 224 mg tobramycin (112 mg b.i.d.). These 56 days represented 1 cycle of therapy during core study.
11133357|NCT01775137|EG001|Reported Event|Extension|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T-326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid). The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
11133358|NCT01775137|EG002|Reported Event|Overall|All participants who inhaled tobramycin inhalation powder during both core and extension study.
11133359|NCT01775189|BG000|Baseline|Entire Study Population|Included all participants enrolled in the study.
11133360|NCT01775189|FG000|Participant Flow|Naloxone|Naloxone hydrochloride (HCl) 0.2 milligram (mg) intravenously followed by additional 0.6 mg naloxone hydrochloride intravenously on Day 0, each dose followed by an assessment for signs and symptoms of opioid withdrawal. Participants who did not display signs and symptoms of opioid withdrawal, were assigned to either oxycodone HCl 30 mg then placebo or placebo then oxycodone HCl 30 mg group in the drug discrimination phase of the study.
11133361|NCT01775189|FG001|Participant Flow|Oxycodone HCl 30 mg Then Placebo|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive oxycodone HCl 30 mg and naltrexone HCl 3.6 mg extended-release (ALO-02) 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (placebo sugar spheres, PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (placebo lactose tablet, PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.
11133362|NCT01775189|FG002|Participant Flow|Placebo Then Oxycodone HCl 30 mg|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive ALO-02 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.
11149616|NCT01871805|OG001|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11133363|NCT01775189|FG003|Participant Flow|PBO Lac, OXY 30 mg, ALO-02 30 mg, PBO SS|Single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in first intervention period; followed by single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in second intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11133364|NCT01775189|FG004|Participant Flow|ALO-02 30 mg, PBO Lac, PBO SS, OXY 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in second intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11133365|NCT01775189|FG005|Participant Flow|OXY 30 mg, PBO SS, PBO Lac, ALO-02 30 mg|Single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in first intervention period; followed by single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in third intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11133366|NCT01775189|FG006|Participant Flow|PBO SS, ALO-02 30 mg, OXY 30 mg, PBO Lac|Single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in third intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
11133367|NCT01775189|OG000|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
11133368|NCT01775189|OG001|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
11133369|NCT01775189|OG002|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
11133370|NCT01775189|OG003|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
11133371|NCT01775189|OG000|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
11133372|NCT01775189|OG001|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
11133373|NCT01775189|OG000|Outcome|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
11133374|NCT01775189|OG001|Outcome|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
11133375|NCT01775189|OG002|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
11133376|NCT01775189|OG003|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
11133377|NCT01775189|OG004|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
11133378|NCT01775189|OG005|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
11133379|NCT01775189|OG006|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
11133380|NCT01775189|OG000|Outcome|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
11133381|NCT01775189|OG001|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
11133382|NCT01775189|OG002|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
11133383|NCT01775189|OG003|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
11133384|NCT01775189|OG004|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
11133385|NCT01775189|OG005|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
11133386|NCT01775189|EG000|Reported Event|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
11133387|NCT01775189|EG001|Reported Event|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
11133388|NCT01775189|EG002|Reported Event|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
11133389|NCT01775189|EG003|Reported Event|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
11133390|NCT01775189|EG004|Reported Event|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
11133391|NCT01775189|EG005|Reported Event|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
11133392|NCT01775189|EG006|Reported Event|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
11133393|NCT01775371|BG000|Baseline|Patient Controlled Analgesia|"PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)~Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes"
11133394|NCT01775371|BG001|Baseline|Usual Care|"Usual opioid analgesia determined by the provider~Usual Care: Usual opioid analgesia determined by the provider"
11133395|NCT01775371|BG002|Baseline|Total|Total of all reporting groups
11133396|NCT01775371|FG000|Participant Flow|Patient Controlled Analgesia|"PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)~Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes"
11133397|NCT01775371|FG001|Participant Flow|Usual Care|"Usual opioid analgesia determined by the provider~Usual Care: Usual opioid analgesia determined by the provider"
11133398|NCT01775371|OG000|Outcome|Patient Controlled Analgesia|"PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)~Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes"
11133399|NCT01775371|OG001|Outcome|Usual Care|"Usual opioid analgesia determined by the provider~Usual Care: Usual opioid analgesia determined by the provider"
11133400|NCT01775371|OG000|Outcome|All Registered Nurses|All Registered Nurses who treated one or more patients in the study
11133401|NCT01775371|OG000|Outcome|All Physicians|All Physicians who entered one or more patients in each arm of the study
11133402|NCT01775371|EG000|Reported Event|Patient Controlled Analgesia|"PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)~Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes"
11133403|NCT01775371|EG001|Reported Event|Usual Care|"Usual opioid analgesia determined by the provider~Usual Care: Usual opioid analgesia determined by the provider"
11133404|NCT01775410|BG000|Baseline|Wolverine System|Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
11133405|NCT01775410|FG000|Participant Flow|Wolverine System|Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
11133406|NCT01775410|OG000|Outcome|Wolverine System|Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
11133407|NCT01775410|EG000|Reported Event|Wolverine System|Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
11133408|NCT01775501|BG000|Baseline|FOLFOX + Sorafenib|"FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks~Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11133409|NCT01775501|FG000|Participant Flow|FOLFOX + Sorafenib|"FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks~Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11133410|NCT01775501|OG000|Outcome|FOLFOX + Sorafenib|"FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks~Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11133411|NCT01775501|EG000|Reported Event|FOLFOX + Sorafenib|"FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks~Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11133412|NCT01775553|BG000|Baseline|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
11133413|NCT01775553|FG000|Participant Flow|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
11133414|NCT01775553|OG000|Outcome|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
11133415|NCT01775553|EG000|Reported Event|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
11133416|NCT01775670|BG000|Baseline|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
11133417|NCT01775670|BG001|Baseline|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
11133418|NCT01775670|BG002|Baseline|Total|Total of all reporting groups
11133419|NCT01775670|FG000|Participant Flow|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for trapeziometacarpal (TMC) arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
11133420|NCT01775670|FG001|Participant Flow|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital (MGH) Occupational Therapists.~Occupational Therapy (OT) Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
11133421|NCT01775670|OG000|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
11133422|NCT01775670|OG001|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
11133423|NCT01775670|EG000|Reported Event|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
11133424|NCT01775670|EG001|Reported Event|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
11133425|NCT01775722|BG000|Baseline|Combined Radio Frequency and Pulsed Dye Laser Treatment|There are two test sites on each Port Wine Stain, one test site was treated with Pulsed dye laser only, and another test site was treated with combined radio frequency and pulsed dye laser. Two test sites were placed side by side randomly on each subject's port wine stain area.
11133426|NCT01775722|FG000|Participant Flow|Combined Radio Frequency and Pulsed Dye Laser Treatment|This is a within-participant design due to the response of port wine stain to laser therapy varies greatly from patient to patient. Pulsed dye laser only test site and combined radio frequency and pulsed dye laser test site were placed side by side on each subject's port wine stain area. Thus the differences among subjects will be explicitly accounted for and removed from the error component when assessing treatment effects.
11133427|NCT01775722|OG000|Outcome|Pulsed Dye Laser Only Treatment|Measurement on the test site treated with Pulsed Dye Laser only.
11133428|NCT01775722|OG001|Outcome|Combined Radio Frequency and Pulsed Dye Laser Treatment|Measurement on test sites treated with combined Radio Frequency and Pulsed Dye Laser.
11133429|NCT01775722|EG000|Reported Event|Pulsed Dye Laser Only Treatment|Adverse event on the test site treated with Pulsed Dye Laser only.
11133430|NCT01775722|EG001|Reported Event|Combined Radio Frequency and Pulsed Dye Laser Treatment|Adverse event on test sites treated with combined Radio Frequency and Pulsed Dye Laser.
11133431|NCT01775735|BG000|Baseline|Treatment|"The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System~Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve"
11133432|NCT01775735|BG001|Baseline|Control|"The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System~Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve"
11133433|NCT01775735|BG002|Baseline|Total|Total of all reporting groups
11133434|NCT01775735|FG000|Participant Flow|Treatment|"The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization~Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve"
11133435|NCT01775735|FG001|Participant Flow|Control|"The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization~Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve"
11133436|NCT01775735|OG000|Outcome|Treatment|"The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization~Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve"
11133437|NCT01775735|OG001|Outcome|Control|"The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization~Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve"
11133438|NCT01775735|EG000|Reported Event|Treatment|"The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization~Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve"
11008726|NCT01098006|BG000|Baseline|Immune Tolerant Patients Group|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
11008727|NCT01098006|BG001|Baseline|HBeAg Positive Group|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
11008728|NCT01098006|BG002|Baseline|Inactive Carriers Group|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
11008729|NCT01098006|BG003|Baseline|HBeAg Negative Group|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
11008730|NCT01098006|BG004|Baseline|Total|Total of all reporting groups
11008731|NCT01098006|FG000|Participant Flow|Immune Tolerant Patients Group|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
11008732|NCT01098006|FG001|Participant Flow|HBeAg Positive Group|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
11008733|NCT01098006|FG002|Participant Flow|Inactive Carriers Group|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
11008734|NCT01098006|FG003|Participant Flow|HBeAg Negative Group|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
11008735|NCT01098006|OG000|Outcome|Immune Tolerant Patients Group|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
11008736|NCT01098006|OG001|Outcome|HBeAg Positive Group|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
11008737|NCT01098006|OG002|Outcome|Inactive Carriers Group|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
11008738|NCT01098006|OG003|Outcome|HBeAg Negative Group|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
11008739|NCT01098006|EG000|Reported Event|Immune Tolerant Patients Group|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
11008740|NCT01098006|EG001|Reported Event|HBeAg Positive Group|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
11008741|NCT01098006|EG002|Reported Event|Inactive Carriers Group|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
11008742|NCT01098006|EG003|Reported Event|HBeAg Negative Group|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
11008743|NCT01098097|BG000|Baseline|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
11008744|NCT01098097|FG000|Participant Flow|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
11008745|NCT01098097|OG000|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
11133439|NCT01775735|EG001|Reported Event|Control|"The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization~Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve"
11133440|NCT01775774|BG000|Baseline|Human Mesenchymal Stem Cells 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133441|NCT01775774|BG001|Baseline|Mesenchymal Stem Cells 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133442|NCT01775774|BG002|Baseline|Mesenchymal Stem Cells 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133443|NCT01775774|BG003|Baseline|Total|Total of all reporting groups
11133444|NCT01775774|FG000|Participant Flow|Human Mesenchymal Stem Cells 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133445|NCT01775774|FG001|Participant Flow|Human Mesenchymal Stem Cells 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133446|NCT01775774|FG002|Participant Flow|Human Mesenchymal Stem Cells 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133447|NCT01775774|OG000|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133448|NCT01775774|OG001|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133449|NCT01775774|OG002|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
11133450|NCT01775774|EG000|Reported Event|Human Mesenchymal Stem Cells: 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
11133451|NCT01775774|EG001|Reported Event|Human Mesenchymal Stem Cells: 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
11133452|NCT01775774|EG002|Reported Event|Human Mesenchymal Stem Cells: 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
11133453|NCT01775787|BG000|Baseline|Nicotine With Tobacco Flavor and With Tobacco & Menthol Flavor|Smokers were assigned to electronic cigarettes containing 18mg/mL of nicotine in either a tobacco flavor solution or a tobacco and menthol flavor solution and then switched to other flavor for an additional 7 to 10 days. Monitoring sessions occurred on the last day of trial period of each flavor.
11133454|NCT01775787|FG000|Participant Flow|Tobacco Flavor/ Tobacco & Menthol Flavor|"Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine"
11008746|NCT01098097|EG000|Reported Event|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
11133455|NCT01775787|FG001|Participant Flow|Tobacco & Menthol Flavor/Tobacco Flavor|"Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
11133456|NCT01775787|OG000|Outcome|Tobacco Flavor|Subjects received tobacco flavored nicotine for 7-10 days
11133457|NCT01775787|OG001|Outcome|Tobacco & Menthol Flavor|Subjects received tobacco & menthol flavored nicotine for 7-10 days
11133458|NCT01775787|EG000|Reported Event|Tobacco Flavor & Tobacco & Menthol Flavor (TOB Flavor)|"AE occurred in intervention Tobacco Flavor Session 17-10 days~Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
11133459|NCT01775787|EG001|Reported Event|Tobacco Flavor & Tobacco & Menthol Flavor (TOB/MENTH Flavor)|"AE occurred in intervention Tobacco Flavor Session 27-10 days~Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
11133460|NCT01775787|EG002|Reported Event|Tobacco & Menthol Flavor & Tobacco Flavor (TOB/MENTH Flavor)|"AE occurred in intervention Tobacco & Menthol Flavor Session 17-10 days~Subjects randomized to Tobacco & Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
11133461|NCT01775787|EG003|Reported Event|Tobacco & Menthol Flavor & Tobacco Flavor (TOB Flavor)|"AE occurred in intervention Tobacco Flavor Session 2 7-10 days~Subjects randomized to Tobacco & Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
11133462|NCT01775800|BG000|Baseline|Treatment Modification|Patients were treated to modified goals in terms of blood pressure, parathyroid hormone and phosphorus
11133463|NCT01775800|BG001|Baseline|Usual Care|Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus
11133464|NCT01775800|BG002|Baseline|Total|Total of all reporting groups
11133465|NCT01775800|FG000|Participant Flow|Treatment Modification|"Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus.~Treatment modification"
11133466|NCT01775800|FG001|Participant Flow|Usual Care|Patients will receive the usual hemodialysis care with no modifications
11133467|NCT01775800|OG000|Outcome|Dialysis Patients|Patients were recruited from two dialysis units, one located in Manhattan and on in Queens, New York, representing the total dialysis population
11133468|NCT01775800|OG000|Outcome|Treatment Modification|Patients were treated to modified goals in terms of blood pressure, parathyroid hormone and phosphorus
11133469|NCT01775800|OG001|Outcome|Usual Care|Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus
11133470|NCT01775800|EG000|Reported Event|Treatment Modification|Patients were treated to modified goals in terms of blood pressure, parathyroid hormone and phosphorus
11133471|NCT01775800|EG001|Reported Event|Usual Care|Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus
11133472|NCT01775852|BG000|Baseline|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
11133473|NCT01775852|BG001|Baseline|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
11133474|NCT01775852|BG002|Baseline|Total|Total of all reporting groups
11133475|NCT01775852|FG000|Participant Flow|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
11133476|NCT01775852|FG001|Participant Flow|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
11133477|NCT01775852|OG000|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
11133478|NCT01775852|OG001|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
11133479|NCT01775852|EG000|Reported Event|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
11133480|NCT01775852|EG001|Reported Event|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
11133481|NCT01775865|BG000|Baseline|Salsalate|Salsalate capusule 1.5 g twice per day by mouth for 4 weeks
11133482|NCT01775865|BG001|Baseline|Placebo|Placebo capsule twice per day by mouth for 4 weeks
11133483|NCT01775865|BG002|Baseline|Young Control|No intervention, not randomized; Baseline measurements only
11133484|NCT01775865|BG003|Baseline|Total|Total of all reporting groups
11133485|NCT01775865|FG000|Participant Flow|Salsalate|"Salsalate capsule 1.5 g twice per day by mouth for 4 weeks~Salsalate"
11008747|NCT01098162|BG000|Baseline|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
11133486|NCT01775865|FG001|Participant Flow|Placebo|"Placebo capsule twice per day by mouth for 4 weeks~Placebo (for salsalate)"
11133487|NCT01775865|FG002|Participant Flow|Young Control|No intervention; Baseline measurements only, participants not randomized
11133488|NCT01775865|OG000|Outcome|Salsalate|Received 4 weeks of daily oral salsalate
11008748|NCT01098162|FG000|Participant Flow|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
11133489|NCT01775865|OG001|Outcome|Placebo|Received 4 weeks of placebo
11133490|NCT01775865|OG002|Outcome|Young Control Group|No Intervention; Baseline measurements only, participants not randomized
11133491|NCT01775865|OG000|Outcome|Salsalate|Salsalate capsule 1.5 g twice per day by mouth for 4 weeks
11133492|NCT01775865|OG001|Outcome|Placebo|Placebo capsule twice per day by mouth for 4 weeks
11133493|NCT01775865|OG002|Outcome|Young Control Group|No intervention; Baseline measurements only; participants not randomized
11133494|NCT01775865|OG001|Outcome|Placebo|Placebo capsules twice per day by mouth for 4 weeks
11133495|NCT01775865|OG002|Outcome|Young Control Group|No intervention; Baseline measurements only, participants not randomized
11133496|NCT01775865|EG000|Reported Event|Salsalate|Salsalate 1.5 g twice per day by mouth for 4 weeks
11133497|NCT01775865|EG001|Reported Event|Placebo|Placebo capusule twice per day by mouth for 4 weeks
11133498|NCT01775865|EG002|Reported Event|Young Control Group|No intervention; Baseline measurements only; Participants not randomized
11133499|NCT01775904|BG000|Baseline|Overall|All participants who entered the study and received at least 1 dose of study drug.
11133500|NCT01775904|FG000|Participant Flow|Total Study Population|All participants who entered the study and received at least 1 dose of study drug.
11133501|NCT01775904|OG000|Outcome|LY2886721 Capsule (Water, Fasting)|A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
11133502|NCT01775904|OG001|Outcome|LY2886721 ODT (no Water, Fasting)|A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
11133503|NCT01775904|OG002|Outcome|LY2886721 ODT (Water, Fed)|A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
11133504|NCT01775904|OG003|Outcome|LY2886721 ODT (Water, Fasting)|A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
11133505|NCT01775904|EG000|Reported Event|LY2886721 Capsule (Water, Fasting)|A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
11133506|NCT01775904|EG001|Reported Event|LY2886721 ODT (no Water, Fasting)|A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
11133507|NCT01775904|EG002|Reported Event|LY2886721 ODT (Water, Fed)|A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
11133508|NCT01775904|EG003|Reported Event|LY2886721 ODT (Water, Fasting)|A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
11133509|NCT01775930|BG000|Baseline|Carfilzomib Treatment|Dosed with 20 mg/mm2 infused on Day 1 and 2. Dosed with 56 mg/mm2 infused on Day 8, 9, 15, and 16.
11133510|NCT01775930|FG000|Participant Flow|Carfilzomib Treatment|Dosed with 20 mg/mm2 infused on Day 1 and 2. Dosed with 56 mg/mm2 infused on Day 8, 9, 15, and 16.
11133511|NCT01775930|OG000|Outcome|Carfilzomib Treatment|Dosed with 20 mg/mm2 infused on Day 1 and 2. Dosed with 56 mg/mm2 infused on Day 8, 9, 15, and 16.
11133512|NCT01775930|EG000|Reported Event|Carfilzomib Treatment|Dosed with 20 mg/mm2 infused on Day 1 and 2. Dosed with 56 mg/mm2 infused on Day 8, 9, 15, and 16.
11133513|NCT01775995|BG000|Baseline|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy~Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
11133514|NCT01775995|BG001|Baseline|Wait-list Control|Standard of Care Therapy only
11133515|NCT01775995|BG002|Baseline|Total|Total of all reporting groups
11133516|NCT01775995|FG000|Participant Flow|Meditation-CBT|"Meditation-CBT + Usual Care~Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management."
11133517|NCT01775995|FG001|Participant Flow|Wait-list Control|"Usual Care~Participants receiving usual care for CLBP and opioid therapy management."
11133518|NCT01775995|OG000|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
11133519|NCT01775995|OG001|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
11133520|NCT01775995|EG000|Reported Event|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy~Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
11133521|NCT01775995|EG001|Reported Event|Wait-list Control|Standard of Care Therapy only
11133522|NCT01776008|BG000|Baseline|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
11133523|NCT01776008|FG000|Participant Flow|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
11133524|NCT01776008|OG000|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
11133525|NCT01776008|EG000|Reported Event|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
11133526|NCT01776268|BG000|Baseline|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
11133527|NCT01776268|BG001|Baseline|no Oral Priming|No oral priming: no intervention
11133528|NCT01776268|BG002|Baseline|Total|Total of all reporting groups
11133529|NCT01776268|FG000|Participant Flow|Colostrum Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
11133530|NCT01776268|FG001|Participant Flow|no Oral Priming|
11133531|NCT01776268|OG000|Outcome|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
11133532|NCT01776268|OG001|Outcome|No Oral Priming|
11133533|NCT01776268|OG001|Outcome|No Oral Priming|No oral priming
11133534|NCT01776268|EG000|Reported Event|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
11133535|NCT01776268|EG001|Reported Event|no Oral Priming|No oral priming: no intervention
11133536|NCT01776424|BG000|Baseline|Rivaroxaban 2.5mg + Aspirin 100mg|Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11008749|NCT01098162|OG000|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
11133537|NCT01776424|BG001|Baseline|Rivaroxaban 5mg + Aspirin Placebo|Participants received Rivaroxaban 5 mg bid and Aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133538|NCT01776424|BG002|Baseline|Rivaroxaban Placebo + Aspirin 100mg|Participants received Rivaroxaban placebo bid and Aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133539|NCT01776424|BG003|Baseline|Total|Total of all reporting groups
11133540|NCT01776424|FG000|Participant Flow|Rivaroxaban 2.5mg + Aspirin 100mg|Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133541|NCT01776424|FG001|Participant Flow|Rivaroxaban 5mg + Aspirin Placebo|Participants received Rivaroxaban 5 mg bid and Aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133542|NCT01776424|FG002|Participant Flow|Rivaroxaban Placebo + Aspirin 100mg|Participants received Rivaroxaban placebo bid and Aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133543|NCT01776424|OG000|Outcome|Rivaroxaban 2.5mg + Aspirin 100mg|Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133544|NCT01776424|OG001|Outcome|Rivaroxaban 5mg + Aspirin Placebo|Participants received Rivaroxaban 5 mg bid and Aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133545|NCT01776424|OG002|Outcome|Rivaroxaban Placebo + Aspirin 100mg|Participants received Rivaroxaban placebo bid and Aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133546|NCT01776424|EG000|Reported Event|Rivaroxaban 2.5mg + Aspirin 100mg|Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11008750|NCT01098162|EG000|Reported Event|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
11133547|NCT01776424|EG001|Reported Event|Rivaroxaban 5mg + Aspirin Placebo|Participants received Rivaroxaban 5 mg bid and Aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133548|NCT01776424|EG002|Reported Event|Rivaroxaban Placebo + Aspirin 100mg|Participants received Rivaroxaban placebo bid and Aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
11133549|NCT01776541|BG000|Baseline|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
11133550|NCT01776541|BG001|Baseline|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
11133551|NCT01776541|BG002|Baseline|Total|Total of all reporting groups
11133552|NCT01776541|FG000|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133553|NCT01776541|FG001|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133554|NCT01776541|OG000|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
11133555|NCT01776541|OG001|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
11133556|NCT01776541|EG000|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133557|NCT01776541|EG001|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133558|NCT01776541|EG002|Reported Event|Total|Total of high dose and low dose groups.
11133559|NCT01776554|BG000|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133560|NCT01776554|BG001|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133561|NCT01776554|BG002|Baseline|Total|Total of all reporting groups
11133562|NCT01776554|FG000|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133563|NCT01776554|FG001|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133564|NCT01776554|OG000|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133565|NCT01776554|OG001|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133566|NCT01776554|EG000|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133567|NCT01776554|EG001|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
11133568|NCT01776554|EG002|Reported Event|Total|Total of subjects in both high dose and low dose groups.
11133569|NCT01776632|BG000|Baseline|Physical Activity|"Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.~Physical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."
11133570|NCT01776632|BG001|Baseline|Cancer Screening|"Latinas exposed to Faith in Action intervention on cancer screening and prevention.~Cancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call."
11133571|NCT01776632|BG002|Baseline|Total|Total of all reporting groups
11133572|NCT01776632|FG000|Participant Flow|Physical Activity|"Latinas exposed to multi-level Faith in Action intervention promoting physical activity.~Physical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."
11133573|NCT01776632|FG001|Participant Flow|Cancer Screening|"Latinas exposed to Faith in Action intervention on cancer screening and prevention.~Cancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call."
11133574|NCT01776632|OG000|Outcome|Physical Activity|"Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.~Physical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."
11133575|NCT01776632|OG001|Outcome|Cancer Screening|"Latinas exposed to Faith in Action intervention on cancer screening and prevention.~Cancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call."
11133576|NCT01776632|EG000|Reported Event|Physical Activity|"Latinas exposed to multi-level Faith in Action intervention promoting physical activity.~Physical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."
11133577|NCT01776632|EG001|Reported Event|Cancer Screening|"Latinas exposed to Faith in Action intervention on cancer screening and prevention.~Cancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call."
11133578|NCT01776645|BG000|Baseline|Compassion Cultivation Training - Participants With Chronic Pa|Compassion Cultivation Training Course - Participants with Chronic Pain
11133579|NCT01776645|BG001|Baseline|Significant Others Group|Significant Others of Participants with Chronic Pain
11133580|NCT01776645|BG002|Baseline|Total|Total of all reporting groups
11133581|NCT01776645|FG000|Participant Flow|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
11133582|NCT01776645|FG001|Participant Flow|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
11133583|NCT01776645|OG000|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
11133584|NCT01776645|EG000|Reported Event|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
11133585|NCT01776645|EG001|Reported Event|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
11133586|NCT01777126|BG000|Baseline|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
10849127|NCT00294398|OG001|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
11133587|NCT01777126|BG001|Baseline|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
11133588|NCT01777126|BG002|Baseline|Total|Total of all reporting groups
11133589|NCT01777126|FG000|Participant Flow|Control Group|In the control group, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
11133590|NCT01777126|FG001|Participant Flow|Oral Nutrition Protocol (ONP) Group|In this group, oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
11133591|NCT01777126|OG000|Outcome|Control Group|For subjects enrolled in this arm, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
11133592|NCT01777126|OG001|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
11133593|NCT01777126|OG000|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
11133594|NCT01777126|OG000|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
11133595|NCT01777126|EG000|Reported Event|Control Group|Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
11149617|NCT01871805|OG002|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149618|NCT01871805|OG003|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11133596|NCT01777126|EG001|Reported Event|Enhanced Recovery Oral Nutrition Protocol (ERONP) Group|Subjects enrolled in this arm will undergo the ERONP protocol. An enhanced oral nutrition protocol (ERONP) with restrictive instructions for parenteral nutrition is implemented. Oral intake is increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used are Fortimel Juicy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. If the patient is unable to produce stools on the third day post-surgery, neostigmine (Prostigmin® 0.5 mg subcutaneous, maximum 4 times a day), an acetylcholinesterase inhibitor promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel, can be administered. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.
11133597|NCT01777139|BG000|Baseline|RTG IR|Eligible participants initially received a starting dose of RTG IR 900 milligrams per day (mg/day) and the same doses of the same concurrent anti-epileptic drugs (AEDs) that they were receiving at the final visit of the transition phase of the parent study. After the first week of the OLE study, the dose of RTG IR could be increased or decreased in increments or decrements 150 mg/day on weekly basis based on efficacy and tolerability. The overall daily dose of RTG IR was to be maintained between a minimum dose of 600 mg/day and a maximum dose of 1200 mg/day.
11133598|NCT01777139|FG000|Participant Flow|RTG IR|Eligible participants initially received a starting dose of RTG IR 900 milligrams per day (mg/day) and the same doses of the same concurrent anti-epileptic drugs (AEDs) that they were receiving at the final visit of the transition phase of the parent study. After the first week of the OLE study, the dose of RTG IR could be increased or decreased in increments or decrements 150 mg/day on weekly basis based on efficacy and tolerability. The overall daily dose of RTG IR was to be maintained between a minimum dose of 600 mg/day and a maximum dose of 1200 mg/day.
11133599|NCT01777139|FG001|Participant Flow|RTG in Safety Follow-up Continuation Phase (SFUCP)|Participants who withdraw from the Open-Label Treatment Phase and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or abnormal discoloration of nails, lips, skin or mucosa were followed-up in SFUCP which was the final reporting phase of the study. During SFUCP, participants underwent six monthly comprehensive eye examinations and/or dermatological assessments. Participants were followed-up until the discoloration /pigmentation either resolves or stabilizes, as defined by no change over two consecutive six monthly assessments over at least 12 months after discontinuation of RTG IR.
11133600|NCT01777139|OG000|Outcome|RTG IR|Eligible participants initially received a starting dose of RTG IR 900 milligrams per day (mg/day) and the same doses of the same concurrent anti-epileptic drugs (AEDs) that they were receiving at the final visit of the transition phase of the parent study. After the first week of the OLE study, the dose of RTG IR could be increased or decreased in increments or decrements 150 mg/day on weekly basis based on efficacy and tolerability. The overall daily dose of RTG IR was to be maintained between a minimum dose of 600 mg/day and a maximum dose of 1200 mg/day.
11133601|NCT01777139|OG000|Outcome|Retigabine IR|All subjects will initially receive a starting dose of retigabine IR at 900 mg/day and after the first week of the OLE study, the dose of retigabine IR may be increased or decreased in increments or decrements of decrements of 150 mg/day on weekly basis based on efficacy and tolerability. The overall daily dose of retigabine IR must be maintained between a minimum dose of 600 mg/day and a maximum dose of 1200 mg/day.
11133602|NCT01777139|OG000|Outcome|RTG in SFUCP|Participants who withdraw from the Open-Label Treatment Phase (i.e., discontinue RTG IR including any dose taper), and who were found to have retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or abnormal discoloration of nails, lips, skin or mucosa were followed-up in SFUCP which was the final reporting phase of the study. During SFUCP, participants underwent six monthly comprehensive eye examinations and/or dermatological assessments. Participants were followed-up until the discoloration /pigmentation either resolves or stabilizes, as defined by no change over two consecutive six monthly assessments over at least 12 months after discontinuation of RTG IR.
11133603|NCT01777139|EG000|Reported Event|RTG IR|Eligible participants initially received a starting dose of RTG IR 900 milligrams per day (mg/day) and the same doses of the same concurrent anti-epileptic drugs (AEDs) that they were receiving at the final visit of the transition phase of the parent study. After the first week of the OLE study, the dose of RTG IR could be increased or decreased in increments or decrements 150 mg/day on weekly basis based on efficacy and tolerability. The overall daily dose of RTG IR was to be maintained between a minimum dose of 600 mg/day and a maximum dose of 1200 mg/day.
11133604|NCT01777139|EG001|Reported Event|RTG in SFUCP|Participants who withdraw from the Open-Label Treatment Phase and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or abnormal discoloration of nails, lips, skin or mucosa were followed-up in SFUCP which was the final reporting phase of the study. During SFUCP, participants underwent six monthly comprehensive eye examinations and/or dermatological assessments. Participants were followed-up until the discoloration /pigmentation either resolves or stabilizes, as defined by no change over two consecutive six monthly assessments over at least 12 months after discontinuation of RTG IR.
11133605|NCT01777152|BG000|Baseline|A+CHP|brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
11133606|NCT01777152|BG001|Baseline|CHOP|cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
11133607|NCT01777152|BG002|Baseline|Total|Total of all reporting groups
11133608|NCT01777152|FG000|Participant Flow|A+CHP|brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
11133609|NCT01777152|FG001|Participant Flow|CHOP|cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
11133610|NCT01777152|OG000|Outcome|A+CHP|brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
11133611|NCT01777152|OG001|Outcome|CHOP|cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
11133612|NCT01777152|EG000|Reported Event|A+CHP|brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
11133613|NCT01777152|EG001|Reported Event|CHOP|cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
11133614|NCT01777152|EG002|Reported Event|A+CHP Subgroup|Includes only participants in A+CHP arm who were randomized but did not receive treatment.
11133615|NCT01777191|BG000|Baseline|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
11133616|NCT01777191|BG001|Baseline|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
11133617|NCT01777191|BG002|Baseline|Total|Total of all reporting groups
11133618|NCT01777191|FG000|Participant Flow|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 milligrams (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every two weeks (Q2W) at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose every 4 weeks (Q4W).
11133619|NCT01777191|FG001|Participant Flow|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
11133620|NCT01777191|OG000|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
11133621|NCT01777191|OG001|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
11133622|NCT01777191|OG000|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
11133623|NCT01777191|EG000|Reported Event|80 mg Ixekizumab Prefilled Syringe Treatment Period|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
11133624|NCT01777191|EG001|Reported Event|80 mg Ixekizumab Auto-Injector Treatment Period|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
11133625|NCT01777191|EG002|Reported Event|80 mg Ixe Prefilled Syringe Optional Safety Extension|One 80 mg Ixekizumab administered as an SC injection Q4W.
11133626|NCT01777191|EG003|Reported Event|Follow Up Period|All participants who received at least 1 dose of Ixekizumab entered the follow-up period.
11133627|NCT01777217|BG000|Baseline|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
11133628|NCT01777217|BG001|Baseline|Placebo|"Drug: Placebo oral~Placebo"
11133629|NCT01777217|BG002|Baseline|Total|Total of all reporting groups
11133630|NCT01777217|FG000|Participant Flow|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
11133631|NCT01777217|FG001|Participant Flow|Placebo|"Drug: Placebo oral~Placebo"
11133632|NCT01777217|OG000|Outcome|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
11133633|NCT01777217|OG001|Outcome|Placebo|"Drug: Placebo oral~Placebo"
11133634|NCT01777217|EG000|Reported Event|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
11133635|NCT01777217|EG001|Reported Event|Placebo|"Drug: Placebo oral~Placebo"
11133636|NCT01777269|BG000|Baseline|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
11133637|NCT01777269|BG001|Baseline|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
11133638|NCT01777269|BG002|Baseline|Total|Total of all reporting groups
11133639|NCT01777269|FG000|Participant Flow|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
11133640|NCT01777269|FG001|Participant Flow|Duodart|Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months
11133641|NCT01777269|OG000|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
11133642|NCT01777269|OG001|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
11133643|NCT01777269|EG000|Reported Event|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
11133644|NCT01777269|EG001|Reported Event|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
11133645|NCT01777282|BG000|Baseline|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133646|NCT01777282|BG001|Baseline|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133647|NCT01777282|BG002|Baseline|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133648|NCT01777282|BG003|Baseline|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133649|NCT01777282|BG004|Baseline|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133650|NCT01777282|BG005|Baseline|Total|Total of all reporting groups
11133651|NCT01777282|FG000|Participant Flow|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133652|NCT01777282|FG001|Participant Flow|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133653|NCT01777282|FG002|Participant Flow|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133654|NCT01777282|FG003|Participant Flow|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133655|NCT01777282|FG004|Participant Flow|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133656|NCT01777282|OG000|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133657|NCT01777282|OG001|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133658|NCT01777282|OG002|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133659|NCT01777282|OG003|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133660|NCT01777282|OG004|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133661|NCT01777282|EG000|Reported Event|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133662|NCT01777282|EG001|Reported Event|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133663|NCT01777282|EG002|Reported Event|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133664|NCT01777282|EG003|Reported Event|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133665|NCT01777282|EG004|Reported Event|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
11133666|NCT01777308|BG000|Baseline|Menitorix Group|Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
11133667|NCT01777308|BG001|Baseline|Meningitec + Hiberix Group|Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
11133668|NCT01777308|BG002|Baseline|Total|Total of all reporting groups
11133669|NCT01777308|FG000|Participant Flow|Menitorix Group|Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
11133670|NCT01777308|FG001|Participant Flow|Meningitec + Hiberix Group|Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
11133671|NCT01777308|OG000|Outcome|Menitorix Group|Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
11133672|NCT01777308|OG001|Outcome|Meningitec + Hiberix Group|Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
11133673|NCT01777308|OG000|Outcome|Menitorix Group|Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm
11133674|NCT01777308|EG000|Reported Event|Menitorix Group|Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
11133675|NCT01777308|EG001|Reported Event|Meningitec + Hiberix Group|Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
11133676|NCT01777321|BG000|Baseline|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
11133677|NCT01777321|BG001|Baseline|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
11133678|NCT01777321|BG002|Baseline|Total|Total of all reporting groups
11133679|NCT01777321|FG000|Participant Flow|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered subcutaneously (SC) on a 0,2-month schedule.
11133680|NCT01777321|FG001|Participant Flow|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered intramuscularly (IM) on a 0,2-month schedule.
11133681|NCT01777321|OG000|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
11133682|NCT01777321|OG001|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
11133683|NCT01777321|EG000|Reported Event|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
11133684|NCT01777321|EG001|Reported Event|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
11133685|NCT01777334|BG000|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
11133686|NCT01777334|BG001|Baseline|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
11133687|NCT01777334|BG002|Baseline|Total|Total of all reporting groups
11133688|NCT01777334|FG000|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
11133689|NCT01777334|FG001|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
11133690|NCT01777334|OG000|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
11133691|NCT01777334|OG001|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
11133692|NCT01777334|EG000|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
11133693|NCT01777334|EG001|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
11133694|NCT01777412|BG000|Baseline|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
11133695|NCT01777412|FG000|Participant Flow|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
11133696|NCT01777412|OG000|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
11133697|NCT01777412|EG000|Reported Event|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
11133698|NCT01777425|BG000|Baseline|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
11133699|NCT01777425|FG000|Participant Flow|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
11133700|NCT01777425|OG000|Outcome|Rhinosinusitis Patients and Status|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
11133701|NCT01777425|OG000|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
11133702|NCT01777425|EG000|Reported Event|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
11133703|NCT01777438|BG000|Baseline|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
11133704|NCT01777438|BG001|Baseline|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
11133705|NCT01777438|BG002|Baseline|Total|Total of all reporting groups
11133706|NCT01777438|FG000|Participant Flow|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
11133707|NCT01777438|FG001|Participant Flow|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
11133708|NCT01777438|OG000|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
11133709|NCT01777438|OG001|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
11133710|NCT01777438|EG000|Reported Event|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
11133711|NCT01777438|EG001|Reported Event|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
11133712|NCT01777490|BG000|Baseline|Arm 1: Control - Caregivers|"Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.~Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally."
11133713|NCT01777490|BG001|Baseline|Arm 1: Control - Patients|"The patient of each informal caregiver was also enrolled with contact limited to assessments.~Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source."
11133714|NCT01777490|BG002|Baseline|Arm 2: HI-FIVES - Caregivers|"Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions.~Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver."
11133715|NCT01777490|BG003|Baseline|Arm 2: HI FIVES - Patients|"The patient of each informal caregiver was also enrolled with contact limited to assessments.~Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source."
11133716|NCT01777490|BG004|Baseline|Total|Total of all reporting groups
11133717|NCT01777490|FG000|Participant Flow|Arm 1: Control - Caregivers|"Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.~Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally."
11133718|NCT01777490|FG001|Participant Flow|Arm 1: Control - Patients|"The patient of each informal caregiver was also enrolled with contact limited to assessments.~Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source."
11133719|NCT01777490|FG002|Participant Flow|Arm 2: HI FIVES - Caregivers|"Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions.~Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver."
11133720|NCT01777490|FG003|Participant Flow|Arm 2: HI-FIVES - Patients|"The patient of each informal caregiver was also enrolled with contact limited to assessments.~Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source."
11133721|NCT01777490|OG000|Outcome|Arm 1: Control|"Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. The patient of each caregiver was also enrolled with contact limited to assessments.~Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally."
11149619|NCT01871805|OG004|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
10849128|NCT00294398|EG000|Reported Event|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
11133722|NCT01777490|OG001|Outcome|Arm 2: HI FIVES|"Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. The patient of each caregiver was also enrolled with contact limited to assessments.~Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver."
11133723|NCT01777490|OG000|Outcome|Arm 1: Control (CAREGIVER)|"Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.~Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally."
11133724|NCT01777490|OG001|Outcome|Arm 1: Control (PATIENT)|The patient of each caregiver was also enrolled with contact limited to assessments.
11133725|NCT01777490|OG002|Outcome|Arm 2: HI FIVES (CAREGIVER)|"Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions.~Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver."
11133726|NCT01777490|OG003|Outcome|Arm 2: HI FIVES (PATIENT)|The patient of each caregiver was also enrolled with contact limited to assessments.
11133727|NCT01777490|EG000|Reported Event|Arm 1: Control - Caregivers|"Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.~Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally."
11133728|NCT01777490|EG001|Reported Event|Arm 1: Control - Patients|"The patient of each informal caregiver was also enrolled with contact limited to assessments.~Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source."
11133729|NCT01777490|EG002|Reported Event|Arm 2: HI-FIVES - Caregivers|"Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions.~Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver."
11133730|NCT01777490|EG003|Reported Event|Arm 2: HI FIVES - Patients|"The patient of each informal caregiver was also enrolled with contact limited to assessments.~Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source."
11133731|NCT01777542|BG000|Baseline|All Participants|All 30 subjects enrolled and randomized in the study
11133732|NCT01777542|FG000|Participant Flow|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
11133733|NCT01777542|FG001|Participant Flow|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
10849129|NCT00294398|EG001|Reported Event|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
11133734|NCT01777542|OG000|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
11133735|NCT01777542|OG001|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
11133736|NCT01777542|EG000|Reported Event|Placebo|This group includes subjects who had a reported Adverse Event (AE) while they were receiving placebo treatment.
11133737|NCT01777542|EG001|Reported Event|rhIGF-1|This group includes subjects who had a reported Adverse Event (AE) while they were receiving rhIGF-1 treatment.
11133738|NCT01777542|EG002|Reported Event|Off Treatment|This group includes subjects who had a reported Adverse Event (AE) while they were not receiving any treatment. This includes the period between Screening and Baseline, the 20-week washout period between study arms, and the 12-week follow up period after study completion.
11133739|NCT01777568|BG000|Baseline|30% Oxygen|"Inspired oxygen will be maintained at 30%.~30% oxygen: Inspired oxygen will be maintained at 30%."
11133740|NCT01777568|BG001|Baseline|80% Oxygen|"Inspired oxygen will be maintained at 80%.~80% oxygen: Inspired oxygen will be maintained at 30%."
11133741|NCT01777568|BG002|Baseline|Total|Total of all reporting groups
11133742|NCT01777568|FG000|Participant Flow|30% Oxygen|"Inspired oxygen will be maintained at 30%.~30% oxygen: Inspired oxygen will be maintained at 30%."
11133743|NCT01777568|FG001|Participant Flow|80% Oxygen|"Inspired oxygen will be maintained at 80%.~80% oxygen: Inspired oxygen will be maintained at 30%."
11133744|NCT01777568|OG000|Outcome|30% Oxygen|"Inspired oxygen will be maintained at 30%.~30% oxygen: Inspired oxygen will be maintained at 30%."
11133745|NCT01777568|OG001|Outcome|80% Oxygen|"Inspired oxygen will be maintained at 80%.~80% oxygen: Inspired oxygen will be maintained at 30%."
11133746|NCT01777568|EG000|Reported Event|30% Oxygen|"Inspired oxygen will be maintained at 30%.~30% oxygen: Inspired oxygen will be maintained at 30%."
11133747|NCT01777568|EG001|Reported Event|80% Oxygen|"Inspired oxygen will be maintained at 80%.~80% oxygen: Inspired oxygen will be maintained at 30%."
11133748|NCT01777581|BG000|Baseline|Milnacipran|Milnacipran, flexibly dosed 100-200 mg/day dosed twice a day
11133749|NCT01777581|BG001|Baseline|Sugar Pill (Placebo)|Placebo
11133750|NCT01777581|BG002|Baseline|Total|Total of all reporting groups
11133751|NCT01777581|FG000|Participant Flow|Milnacipran|Milnacipran, flexibly dosed
11133752|NCT01777581|FG001|Participant Flow|Sugar Pill (Placebo)|Placebo
11133753|NCT01777581|OG000|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
11133754|NCT01777581|OG001|Outcome|Sugar Pill (Placebo)|Placebo
11133755|NCT01777581|EG000|Reported Event|Milnacipran|Milnacipran, flexibly dosed
11133756|NCT01777581|EG001|Reported Event|Sugar Pill (Placebo)|Placebo
11133757|NCT01777620|BG000|Baseline|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
11133758|NCT01777620|BG001|Baseline|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
11133759|NCT01777620|BG002|Baseline|Total|Total of all reporting groups
11133760|NCT01777620|FG000|Participant Flow|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
11133761|NCT01777620|FG001|Participant Flow|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
11133762|NCT01777620|OG000|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
11133763|NCT01777620|OG001|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
10849130|NCT00294515|BG000|Baseline|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
11133764|NCT01777620|EG000|Reported Event|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
11133765|NCT01777620|EG001|Reported Event|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
11133766|NCT01777763|BG000|Baseline|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days.
11133767|NCT01777763|BG001|Baseline|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days.
11133768|NCT01777763|BG002|Baseline|Total|Total of all reporting groups
11133769|NCT01777763|FG000|Participant Flow|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
11133770|NCT01777763|FG001|Participant Flow|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
11133771|NCT01777763|OG000|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
11133772|NCT01777763|OG001|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
11133773|NCT01777763|EG000|Reported Event|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
11133774|NCT01777763|EG001|Reported Event|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
11133775|NCT01777776|BG000|Baseline|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133776|NCT01777776|BG001|Baseline|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133777|NCT01777776|BG002|Baseline|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133778|NCT01777776|BG003|Baseline|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133779|NCT01777776|BG004|Baseline|Total|Total of all reporting groups
11133780|NCT01777776|FG000|Participant Flow|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133781|NCT01777776|FG001|Participant Flow|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133782|NCT01777776|FG002|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133783|NCT01777776|FG003|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133784|NCT01777776|OG000|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133785|NCT01777776|OG001|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133786|NCT01777776|OG002|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133787|NCT01777776|OG003|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133788|NCT01777776|OG000|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
11133789|NCT01777776|OG001|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
11133790|NCT01777776|OG000|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
11133791|NCT01777776|OG000|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
11133792|NCT01777776|OG001|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
11133793|NCT01777776|OG002|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
11133794|NCT01777776|OG003|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
11133795|NCT01777776|OG001|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
11133796|NCT01777776|OG002|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
11133797|NCT01777776|EG000|Reported Event|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133798|NCT01777776|EG001|Reported Event|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133799|NCT01777776|EG002|Reported Event|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133800|NCT01777776|EG003|Reported Event|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
11133801|NCT01777932|BG000|Baseline|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
11133802|NCT01777932|FG000|Participant Flow|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
11133803|NCT01777932|OG000|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
11133804|NCT01777932|EG000|Reported Event|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
11133805|NCT01777945|BG000|Baseline|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
11133806|NCT01777945|FG000|Participant Flow|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
11133807|NCT01777945|OG000|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
11133808|NCT01777945|EG000|Reported Event|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
11133809|NCT01777997|BG000|Baseline|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
11133810|NCT01777997|FG000|Participant Flow|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily. Participants in the primary outcome analysis were on ART for at least 24 weeks and up to 48 weeks.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment. Participants in exploratory analyses were on ART for at least 72 weeks and up to 96 weeks."
11133811|NCT01777997|OG000|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
11133812|NCT01777997|EG000|Reported Event|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
11133813|NCT01778010|BG000|Baseline|Modafinil + Cocaine|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133814|NCT01778010|FG000|Participant Flow|Modafinil + Cocaine|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and underwent a dose response of smoked cocaine (0, 12, 25, and 50mg).
11133815|NCT01778010|OG000|Outcome|Modafinil 0mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133816|NCT01778010|OG001|Outcome|Modafinil 200mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133817|NCT01778010|OG002|Outcome|Modafinil 400mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133818|NCT01778010|OG003|Outcome|Modafinil 0mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133819|NCT01778010|OG004|Outcome|Modafinil 200mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133820|NCT01778010|OG005|Outcome|Modafinil 400mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133821|NCT01778010|OG006|Outcome|Modafinil 0mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133822|NCT01778010|OG007|Outcome|Modafinil 200mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133823|NCT01778010|OG008|Outcome|Modafinil 400mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133824|NCT01778010|OG009|Outcome|Modafinil 0mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133825|NCT01778010|OG010|Outcome|Modafinil 200mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133826|NCT01778010|OG011|Outcome|Modafinil 400mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
11133827|NCT01778010|EG000|Reported Event|Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg)|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (0 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg).
11133828|NCT01778010|EG001|Reported Event|Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg)|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (200 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg).
11133829|NCT01778010|EG002|Reported Event|Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg)|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (400 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg).
11133830|NCT01778023|BG000|Baseline|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
11133831|NCT01778023|BG001|Baseline|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
11133832|NCT01778023|BG002|Baseline|Total|Total of all reporting groups
11133833|NCT01778023|FG000|Participant Flow|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
10849131|NCT00294515|BG001|Baseline|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
10849132|NCT00294515|BG002|Baseline|Total|Total of all reporting groups
10849133|NCT00294515|FG000|Participant Flow|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
11133834|NCT01778023|FG001|Participant Flow|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
11133835|NCT01778023|OG000|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
11133836|NCT01778023|OG001|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
11133837|NCT01778023|EG000|Reported Event|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
11133838|NCT01778023|EG001|Reported Event|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
11133839|NCT01778049|BG000|Baseline|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
11133840|NCT01778049|BG001|Baseline|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
11133841|NCT01778049|BG002|Baseline|Total|Total of all reporting groups
11133842|NCT01778049|FG000|Participant Flow|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
11133843|NCT01778049|FG001|Participant Flow|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
11133844|NCT01778049|FG002|Participant Flow|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
11133845|NCT01778049|FG003|Participant Flow|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
11133846|NCT01778049|FG004|Participant Flow|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
11133847|NCT01778049|FG005|Participant Flow|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
11133848|NCT01778049|OG000|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
11133849|NCT01778049|OG001|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
11133850|NCT01778049|OG002|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
11133851|NCT01778049|OG003|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
11133852|NCT01778049|EG000|Reported Event|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
11133853|NCT01778049|EG001|Reported Event|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
11133854|NCT01778049|EG002|Reported Event|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
11133855|NCT01778049|EG003|Reported Event|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
11133856|NCT01778049|EG004|Reported Event|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
10849134|NCT00294515|FG001|Participant Flow|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
10849135|NCT00294515|OG000|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
10849136|NCT00294515|OG001|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
11133857|NCT01778049|EG005|Reported Event|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
11133858|NCT01778062|BG000|Baseline|Indacaterol|Indacaterol 150 µg once daily
11133859|NCT01778062|BG001|Baseline|Placebo|Placebo once daily
11133860|NCT01778062|BG002|Baseline|Total|Total of all reporting groups
11133861|NCT01778062|FG000|Participant Flow|Indacaterol|Indacaterol 150 µg once daily
11133862|NCT01778062|FG001|Participant Flow|Placebo|Placebo once daily
11133863|NCT01778062|OG000|Outcome|Indacaterol|Indacaterol 150 µg once daily
11133864|NCT01778062|OG001|Outcome|Placebo|Placebo once daily
11133865|NCT01778062|EG000|Reported Event|Indacaterol|Indacaterol
11133866|NCT01778062|EG001|Reported Event|Placebo|Placebo
11133867|NCT01778127|BG000|Baseline|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133868|NCT01778127|BG001|Baseline|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133869|NCT01778127|BG002|Baseline|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133870|NCT01778127|BG003|Baseline|Total|Total of all reporting groups
11133871|NCT01778127|FG000|Participant Flow|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133872|NCT01778127|FG001|Participant Flow|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133873|NCT01778127|FG002|Participant Flow|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133874|NCT01778127|OG000|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133875|NCT01778127|OG001|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133876|NCT01778127|OG002|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
10849137|NCT00294515|EG000|Reported Event|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
10849138|NCT00294515|EG001|Reported Event|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
11133877|NCT01778127|EG000|Reported Event|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133878|NCT01778127|EG001|Reported Event|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133879|NCT01778127|EG002|Reported Event|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
11133880|NCT01778179|BG000|Baseline|Group 1|"Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).~Post-procedure phase (Week 2 up to Week 13)~Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.~Second treatment phase (Week 5 to Week 13):~Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH."
11133881|NCT01778179|BG001|Baseline|Group 2|"Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).~Post-procedure phase (Week 2 up to Week 13)~Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.~Second treatment phase (Week 5 to Week 13):~Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH."
11133882|NCT01778179|BG002|Baseline|Total|Total of all reporting groups
11133883|NCT01778179|FG000|Participant Flow|Group 1|"Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).~Post-procedure phase (Week 2 up to Week 13)~Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.~Second treatment phase (Week 5 to Week 13):~Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of post inflammatory hyperpigmentation."
11133884|NCT01778179|FG001|Participant Flow|Group 2|"Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).~Post-procedure phase (Week 2 up to Week 13)~Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.~Second treatment phase (Week 5 to Week 13):~Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of post inflammatory hyperpigmentation."
11133885|NCT01778179|OG000|Outcome|Group 1|"Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).~Post-procedure phase (Week 2 up to Week 13)~Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.~Second treatment phase (Week 5 to Week 13):~Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH."
11149620|NCT01871805|OG000|Outcome|Alectinib: Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 600, 760, or 900 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149621|NCT01871805|OG000|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
10879656|NCT00459186|OG000|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
10879657|NCT00459186|EG000|Reported Event|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
10879658|NCT00459290|BG000|Baseline|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
11008751|NCT01098240|BG000|Baseline|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
11008752|NCT01098240|FG000|Participant Flow|Open-Label Antidepressant Treatment (ADT)|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 milligram/day [mg/d]), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine controlled-release (CR) (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
11008753|NCT01098240|FG001|Participant Flow|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg every evening (QPM) for 3 days, then 1 mg twice daily (BID) for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
11008754|NCT01098240|FG002|Participant Flow|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
11008755|NCT01098240|OG000|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
11008756|NCT01098240|OG001|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
11008757|NCT01098240|EG000|Reported Event|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
11008758|NCT01098240|EG001|Reported Event|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
11008759|NCT01098240|EG002|Reported Event|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
11008760|NCT01098253|BG000|Baseline|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
11008761|NCT01098253|BG001|Baseline|Usual Care|
11008762|NCT01098253|BG002|Baseline|Total|Total of all reporting groups
11008763|NCT01098253|FG000|Participant Flow|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
11008764|NCT01098253|FG001|Participant Flow|Usual Care|
11008765|NCT01098253|OG000|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
11008766|NCT01098253|OG001|Outcome|Usual Care|
11008767|NCT01098253|EG000|Reported Event|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
11008768|NCT01098253|EG001|Reported Event|Usual Care|
11067011|NCT01394718|FG001|Participant Flow|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
11133886|NCT01778179|OG001|Outcome|Group 2|"Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).~Post-procedure phase (Week 2 up to Week 13)~Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.~Second treatment phase (Week 5 to Week 13):~Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH."
11133887|NCT01778179|EG000|Reported Event|Group 1|"Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).~Post-procedure phase (Week 2 up to Week 13)~Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.~Second treatment phase (Week 5 to Week 13):~Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH."
11133888|NCT01778179|EG001|Reported Event|Group 2|"Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).~Post-procedure phase (Week 2 up to Week 13)~Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.~Second treatment phase (Week 5 to Week 13):~Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH."
11133889|NCT01778296|BG000|Baseline|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
11133890|NCT01778296|FG000|Participant Flow|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
11133891|NCT01778296|OG000|Outcome|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
11133892|NCT01778296|EG000|Reported Event|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
11133893|NCT01778426|BG000|Baseline|Primo-implant (PI)|Subjects implanted for the first time (primary implant group) with Medtronic SCS devices, in order to assess the effectiveness of the treatment compared to pre-operative situation.
11133894|NCT01778426|BG001|Baseline|Replacement (RP)|Subjects implanted with a new Medtronic SCS neurostimulator as a replacement of their Medtronic SCS devices (replacement group), in order to document the integrality of the practice and collect long-term data like complications and definitive explants.
11133895|NCT01778426|BG002|Baseline|Total|Total of all reporting groups
10879659|NCT00459290|FG000|Participant Flow|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
10879660|NCT00459290|OG000|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
10879661|NCT00459290|OG000|Outcome|Not Platinum Sensitive|
10879662|NCT00459290|OG001|Outcome|Platinum Sensitive|
10879663|NCT00459290|OG000|Outcome|GOG Performance Status 0|Fully active, able to carry on all pre-disease performance without restriction.
11133896|NCT01778426|FG000|Participant Flow|Primo-implant (PI)|Subjects implanted for the first time with Medtronic SCS devices, in order to assess the effectiveness of the treatment compared to pre-operative situation.
11133897|NCT01778426|FG001|Participant Flow|Replacement (RP)|Subjects implanted with a new Medtronic SCS neurostimulator as a replacement of their Medtronic SCS devices, in order to document the integrality of the practice and collect long-term data like complications and definitive explants.
10879664|NCT00459290|OG001|Outcome|GOG Performance Status 1|Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
10879665|NCT00459290|OG000|Outcome|< 60|
10879666|NCT00459290|OG001|Outcome|60 <70|
10879667|NCT00459290|OG002|Outcome|>=70|
10879668|NCT00459290|EG000|Reported Event|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
10879669|NCT00459303|BG000|Baseline|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
10879670|NCT00459303|FG000|Participant Flow|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye.
10879671|NCT00459303|OG000|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
10879672|NCT00459303|OG001|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
10879673|NCT00459303|OG001|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
10879674|NCT00459303|OG001|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
11133898|NCT01778426|OG000|Outcome|Primo-implant (PI)|Subjects implanted for the first time with Medtronic SCS devices
11133899|NCT01778426|OG000|Outcome|Primo-implant - Baseline|Subjects implanted for the first time with Medtronic SCS devices. Results at baseline.
11133900|NCT01778426|OG001|Outcome|Primo-implant - 1 Year|Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.
11133901|NCT01778426|OG002|Outcome|Primo-implant - 2 Years|Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
11133902|NCT01778426|OG000|Outcome|Primo-implant - 1 Year|Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.
11133903|NCT01778426|OG001|Outcome|Primo-implant - 2 Years|Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
11133904|NCT01778426|EG000|Reported Event|Full Analysis Set (FAS)|FAS includes all subjects from primo-implant (n=264) and replacement (n=138) groups enrolled in the study with a valid Patient Data Release Form. 402 subjects were analyzed in the FAS.
11133905|NCT01778465|BG000|Baseline|All Study Participants|Participants followed a low salicylate diet for one week. Then, participants continued with a normal diet for one week.
11133906|NCT01778465|FG000|Participant Flow|Low Salicylate Diet, Then Normal Diet|Participants followed a low salicylate diet for 7 days, then they started a period of 7 days on Normal diet.
10879675|NCT00459303|OG001|Outcome|Aspheric Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
11133907|NCT01778465|FG001|Participant Flow|Normal Diet, Then Low Salicylate Diet|Participants followed a normal diet for 7 days, then they started a period of 7 days on Low Salicylate Diet
11133908|NCT01778465|OG000|Outcome|Low Salicylate Diet|Patients followed a low salicylate diet for one week
11133909|NCT01778465|OG001|Outcome|Normal Diet|Patients followed a Normal diet for one week.
11133910|NCT01778465|OG001|Outcome|Normal Diet|Participants followed a normal diet for 7 days
11133911|NCT01778465|OG000|Outcome|Low Salicylate Diet|Participants followed a low salicylate diet for 7 days
11133912|NCT01778465|OG000|Outcome|Low Salicylate Diet|Patients followed a low salicylate diet for one week.
11133913|NCT01778465|EG000|Reported Event|Low Salicylate Diet|Participants followed a low salicylate diet for 7 days
11133914|NCT01778465|EG001|Reported Event|Normal Diet|Participants followed a normal diet for 7 days
11133915|NCT01778530|BG000|Baseline|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
11133916|NCT01778530|FG000|Participant Flow|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
11133917|NCT01778530|OG000|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
11133918|NCT01778530|EG000|Reported Event|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
11133919|NCT01778556|BG000|Baseline|Leptin Naive|"Studied for 5 days without metreleptin, then 14 days while taking metreleptin~Metreleptin: Recombinant analog of the human hormone, leptin"
11133920|NCT01778556|BG001|Baseline|On-leptin|"Studied for 5 days while taking metreleptin, then 14 days during metreleptin withdrawal~Metreleptin: Recombinant analog of the human hormone, leptin"
11133921|NCT01778556|BG002|Baseline|Total|Total of all reporting groups
11133922|NCT01778556|FG000|Participant Flow|Leptin Naive|"Studied for 5 days without metreleptin, then 14 days while taking metreleptin~Metreleptin: Recombinant analog of the human hormone, leptin"
11133923|NCT01778556|FG001|Participant Flow|On-leptin|"Studied for 5 days while taking metreleptin, then 14 days during metreleptin withdrawal~Metreleptin: Recombinant analog of the human hormone, leptin"
11133924|NCT01778556|OG000|Outcome|Leptin Naive|"Studied for 5 days without metreleptin, then 14 days while taking metreleptin~Metreleptin: Recombinant analog of the human hormone, leptin"
11133925|NCT01778556|OG001|Outcome|On-leptin|"Studied for 5 days while taking metreleptin, then 14 days during metreleptin withdrawal~Metreleptin: Recombinant analog of the human hormone, leptin"
11133926|NCT01778556|EG000|Reported Event|Intervention 1 (5 Days) : Leptin Naive|"Studied for 5 days without taking metreleptin.~Metreleptin: Recombinant analog of the human hormone, leptin"
11133927|NCT01778556|EG001|Reported Event|Intervention 2 (14 Days): Leptin Naive|Studied for 14 days while taking metreleptin after the intervention 1 (5 days) : Leptin Naive Metreleptin: Recombinant analog of the human hormone, leptin
11133928|NCT01778556|EG002|Reported Event|Long-term Follow-up (6 Months): Leptin Naive|"Studied for 6 months while taking metreleptin after intervention 2 (14 days): Leptin Naive~Metreleptin: Recombinant analog of the human hormone, leptin"
11133929|NCT01778556|EG003|Reported Event|Intervention 1 ( 5 Days) : On-Leptin|"Studied for 5 days while taking metreleptin~Metreleptin: Recombinant analog of the human hormone, leptin"
11133930|NCT01778556|EG004|Reported Event|Intervention 1 ( 14 Days): On-Leptin|"Studied for 14 days during metreleptin withdrawal after Intervention 1 ( 5 days) : On-Leptin~Metreleptin: Recombinant analog of the human hormone, leptin"
11133931|NCT01778634|BG000|Baseline|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
11133932|NCT01778634|BG001|Baseline|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
11133933|NCT01778634|BG002|Baseline|Total|Total of all reporting groups
11133934|NCT01778634|FG000|Participant Flow|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
11133935|NCT01778634|FG001|Participant Flow|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
11133936|NCT01778634|OG000|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
11133937|NCT01778634|OG001|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
11133938|NCT01778634|OG000|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W"
11133939|NCT01778634|EG000|Reported Event|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
11133940|NCT01778634|EG001|Reported Event|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
11133941|NCT01778751|BG000|Baseline|Control|Veterans will receive diabetes educational materials and management per their primary provider
11133942|NCT01778751|BG001|Baseline|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
11133943|NCT01778751|BG002|Baseline|Total|Total of all reporting groups
11133944|NCT01778751|FG000|Participant Flow|Control|Veterans will receive diabetes educational materials and management per their primary provider
11133945|NCT01778751|FG001|Participant Flow|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
11133946|NCT01778751|OG000|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
11133947|NCT01778751|OG001|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
11133948|NCT01778751|EG000|Reported Event|Control|Veterans will receive diabetes educational materials and management per their primary provider
11133949|NCT01778751|EG001|Reported Event|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
11133950|NCT01778855|BG000|Baseline|Normothermia|IV t-PA and normothermia
11133951|NCT01778855|BG001|Baseline|Hypothermia|IV t-PA and hypothermia
11133952|NCT01778855|BG002|Baseline|Total|Total of all reporting groups
11133953|NCT01778855|FG000|Participant Flow|Normothermia|IV t-PA and normothermia
11133954|NCT01778855|FG001|Participant Flow|Hypothermia|IV t-PA and hypothermia
11133955|NCT01778855|OG000|Outcome|Normothermia|IV t-PA and normothermia
11133956|NCT01778855|OG001|Outcome|Hypothermia|IV t-PA and hypothermia
11133957|NCT01778855|EG000|Reported Event|Normothermia|IV t-PA and normothermia
11133958|NCT01778855|EG001|Reported Event|Hypothermia|IV t-PA and hypothermia
11133959|NCT01778985|BG000|Baseline|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
11133960|NCT01778985|BG001|Baseline|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
11133961|NCT01778985|BG002|Baseline|Total|Total of all reporting groups
11133962|NCT01778985|FG000|Participant Flow|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
11133963|NCT01778985|FG001|Participant Flow|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
10849774|NCT00298155|OG002|Outcome|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
11133964|NCT01778985|OG000|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
11133965|NCT01778985|OG001|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
11133966|NCT01778985|EG000|Reported Event|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
11133967|NCT01778985|EG001|Reported Event|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
11133968|NCT01779024|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Ghrelin or Placebo
11133969|NCT01779024|FG000|Participant Flow|Ghrelin, Then Placebo|Intravenous acyl-ghrelin a loading dose (3 mcg/kg), followed by a continuous infusion (16.9 ng/kg/min)] was administered on the first visit; Intravenous placebo [packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor] was administered on the second visit.
11133970|NCT01779024|FG001|Participant Flow|Placebo, Then Ghrelin|Intravenous placebo packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor] was administered on the first visit; Intravenous acyl-ghrelin [a loading dose (3 mcg/kg), followed by a continuous infusion (16.9 ng/kg/min)] was administered on the second visit
11133971|NCT01779024|OG000|Outcome|Ghrelin|Intravenous acyl-ghrelin a loading dose (3 mcg/kg), followed by a continous infusion (16.9 ng/kg/min)] was administered on the first ASA visit; Intravenous placebo [packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor] was administered on the second ASA visit.
11133972|NCT01779024|OG001|Outcome|Placebo|Intravenous placebo packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor] was administered on the first ASA visit; Intravenous acyl-ghrelin [a loading dose (3 mcg/kg), followed by a continous infusion (16.9 ng/kg/min)] was administered on the second ASA visit
11133973|NCT01779024|EG000|Reported Event|Ghrelin|Intravenous acyl-ghrelin a loading dose (3 mcg/kg), followed by a continous infusion (16.9 ng/kg/min)] was administered on the first visit; Intravenous placebo [packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor] was administered on the second visit.
11133974|NCT01779024|EG001|Reported Event|Placebo|Intravenous placebo packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor] was administered on the first visit; Intravenous acyl-ghrelin [a loading dose (3 mcg/kg), followed by a continous infusion (16.9 ng/kg/min)] was administered on the second visit
11133975|NCT01779141|BG000|Baseline|CSII|Patients using CSII, with or without CGM
11133976|NCT01779141|FG000|Participant Flow|CSII|Patients using CSII, with or without CGM
11133977|NCT01779141|OG000|Outcome|CSII|Patients using CSII, with or without CGM
11133978|NCT01779141|EG000|Reported Event|CSII|Patients using CSII, with or without CGM
11149622|NCT01871805|OG000|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149623|NCT01871805|OG001|Outcome|Alectinib Other Than 600 mg (Fasted/Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 760, or 900 mg on Cycle 1 Day -3 and then received 300, 460, 760, or 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149624|NCT01871805|OG000|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149625|NCT01871805|OG001|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149626|NCT01871805|OG002|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149627|NCT01871805|OG003|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149628|NCT01871805|OG004|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149629|NCT01871805|OG005|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149630|NCT01871805|OG006|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149631|NCT01871805|OG007|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149632|NCT01871805|OG008|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149633|NCT01871805|OG002|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
10849775|NCT00298155|EG000|Reported Event|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
11149634|NCT01871805|OG003|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149635|NCT01871805|OG004|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149636|NCT01871805|OG005|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149637|NCT01871805|OG006|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11008769|NCT01098266|BG000|Baseline|A: NGR-hTNF + BIC|"NGR-hTNF plus Best Investigator's Choice~NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
11008770|NCT01098266|BG001|Baseline|B: Placebo+BIC|"Placebo plus Best Investigator's Choice~Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
11008771|NCT01098266|BG002|Baseline|Total|Total of all reporting groups
11008772|NCT01098266|FG000|Participant Flow|A: NGR-hTNF + BIC|"NGR-hTNF plus Best Investigator's Choice~NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
11008773|NCT01098266|FG001|Participant Flow|B: Placebo+BIC|"Placebo plus Best Investigator's Choice~Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
11008774|NCT01098266|OG000|Outcome|A: NGR-hTNF + BIC|"NGR-hTNF plus Best Investigator's Choice~NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
11008775|NCT01098266|OG001|Outcome|B: Placebo+BIC|"Placebo plus Best Investigator's Choice~Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
11008776|NCT01098266|EG000|Reported Event|A: NGR-hTNF + BIC|"NGR-hTNF plus Best Investigator's Choice~NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
11008777|NCT01098266|EG001|Reported Event|B: Placebo+BIC|"Placebo plus Best Investigator's Choice~Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
11149638|NCT01871805|EG000|Reported Event|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11133979|NCT01779167|BG000|Baseline|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
11133980|NCT01779167|FG000|Participant Flow|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
11133981|NCT01779167|OG000|Outcome|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
11133982|NCT01779167|EG000|Reported Event|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
11133983|NCT01779219|BG000|Baseline|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with was used in all procedures."
11133984|NCT01779219|BG001|Baseline|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
11133985|NCT01779219|BG002|Baseline|Total|Total of all reporting groups
11133986|NCT01779219|FG000|Participant Flow|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) was used in all cases."
11133987|NCT01779219|FG001|Participant Flow|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
11133988|NCT01779219|OG000|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
10849776|NCT00298155|EG001|Reported Event|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
11133989|NCT01779219|OG001|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
11133990|NCT01779219|EG000|Reported Event|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
11133991|NCT01779219|EG001|Reported Event|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
11133992|NCT01779375|BG000|Baseline|Metformin Alone|Metformin was titrated beginning at 500 mg/day to the maximum dose tolerated (up to 2000 mg/day).
11133993|NCT01779375|BG001|Baseline|Glargine Followed by Metformin|Basal insulin glargine was titrated to achieve a morning fasting blood glucose of 85-95 mg/dl and continued through 3 months after which metformin was titrated as in the Metformin alone arm and continued for 9 months.
11133994|NCT01779375|BG002|Baseline|Total|Total of all reporting groups
11133995|NCT01779375|FG000|Participant Flow|Metformin Alone|Metformin was titrated beginning at 500 mg/day to the maximum dose tolerated (up to 2000 mg/day).
11133996|NCT01779375|FG001|Participant Flow|Glargine Followed by Metformin|Basal insulin glargine was titrated to achieve a morning fasting blood glucose of 85-95 mg/dl and continued through 3 months after which metformin was titrated as in the Metformin alone arm and continued for 9 months.
11133997|NCT01779375|OG000|Outcome|Metformin Alone|Metformin was titrated beginning at 500 mg/day to the maximum dose tolerated (up to 2000 mg/day).
11133998|NCT01779375|OG001|Outcome|Glargine Followed by Metformin|Basal insulin glargine was titrated to achieve a morning fasting blood glucose of 85-95 mg/dl and continued through 3 months after which metformin was titrated as in the Metformin alone arm and continued for 9 months.
11133999|NCT01779375|OG000|Outcome|Metformin Alone|"Metformin will be titrated to the maximum dose tolerated (up to 2000 mg/day).~Metformin"
11134000|NCT01779375|OG001|Outcome|Glargine Followed by Metformin|"Basal insulin glargine for 3 months titrated to achieve a morning fasting blood glucose of 85-95 mg/dl, followed by metformin (titrated up to 2000 mg/day) for 9 months.~Metformin~Glargine"
11134001|NCT01779375|EG000|Reported Event|Metformin Alone|Metformin was titrated beginning at 500 mg/day to the maximum dose tolerated (up to 2000 mg/day).
11134002|NCT01779375|EG001|Reported Event|Glargine Followed by Metformin|Basal insulin glargine was titrated to achieve a morning fasting blood glucose of 85-95 mg/dl and continued through 3 months after which metformin was titrated as in the Metformin alone arm and continued for 9 months.
11134003|NCT01779440|BG000|Baseline|Electronic Decision Support System|"The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment.~Electronic Decision Support System"
11134004|NCT01779440|BG001|Baseline|Control Computer Program|"A computer program aimed to educate people about smoking cessation treatment.~Electronic Decision Support System"
11134005|NCT01779440|BG002|Baseline|Total|Total of all reporting groups
11134006|NCT01779440|FG000|Participant Flow|Electronic Decision Support System|"The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment.~Electronic Decision Support System"
11134007|NCT01779440|FG001|Participant Flow|Control Computer Program|"A computer program aimed to educate people about smoking cessation treatment.~Electronic Decision Support System"
11134008|NCT01779440|OG000|Outcome|Electronic Decision Support System|"The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment.~Electronic Decision Support System"
11134009|NCT01779440|OG001|Outcome|Control Computer Program|"A computer program aimed to educate people about smoking cessation treatment.~Electronic Decision Support System"
11134010|NCT01779440|EG000|Reported Event|Electronic Decision Support System|"The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment.~Electronic Decision Support System"
11134011|NCT01779440|EG001|Reported Event|Control Computer Program|"A computer program aimed to educate people about smoking cessation treatment.~Electronic Decision Support System"
10879676|NCT00459303|EG000|Reported Event|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
11134012|NCT01779648|BG000|Baseline|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
11134013|NCT01779648|BG001|Baseline|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
11134014|NCT01779648|BG002|Baseline|Total|Total of all reporting groups
11134015|NCT01779648|FG000|Participant Flow|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~Simultaneous compression +Fixed refill time:"
11134016|NCT01779648|FG001|Participant Flow|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~Alternate compression+Adjusted refill time"
11134017|NCT01779648|OG000|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
11134018|NCT01779648|OG001|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
11134019|NCT01779648|EG000|Reported Event|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
11134020|NCT01779648|EG001|Reported Event|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
11134021|NCT01779700|BG000|Baseline|Fingolimod|"0.5mg of fingolimod, oral administration, daily, for 8 weeks.~Fingolimod: 0.5mg each day of 8 week cycle"
11134022|NCT01779700|BG001|Baseline|Placebo|"placebo, oral administration, daily, for 8 weeks.~placebo: 1 tablet each day of 8 week cycle"
11134023|NCT01779700|BG002|Baseline|Total|Total of all reporting groups
11134024|NCT01779700|FG000|Participant Flow|Fingolimod|"0.5mg of fingolimod, oral administration, daily, for 8 weeks.~Fingolimod: 0.5mg each day of 8 week cycle"
11134025|NCT01779700|FG001|Participant Flow|Placebo|"placebo, oral administration, daily, for 8 weeks.~placebo: 1 tablet each day of 8 week cycle"
10879677|NCT00459316|BG000|Baseline|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%<25
10879678|NCT00459316|BG001|Baseline|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
10879679|NCT00459316|BG002|Baseline|Group 2|Participants ≥11 to <25 years with CD4%<15
11134026|NCT01779700|OG000|Outcome|Fingolimod|"0.5mg of fingolimod, oral administration, daily, for 8 weeks.~Fingolimod: 0.5mg each day of 8 week cycle"
11134027|NCT01779700|OG001|Outcome|Placebo|"placebo, oral administration, daily, for 8 weeks.~placebo: 1 tablet each day of 8 week cycle"
11134028|NCT01779700|EG000|Reported Event|Fingolimod|"0.5mg of fingolimod, oral administration, daily, for 8 weeks.~Fingolimod: 0.5mg each day of 8 week cycle"
11134029|NCT01779700|EG001|Reported Event|Placebo|"placebo, oral administration, daily, for 8 weeks.~placebo: 1 tablet each day of 8 week cycle"
11134030|NCT01779856|BG000|Baseline|REVEAL Insertable Cardiac Monitor (ICM)|"Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics.~REVEAL Insertable Cardiac Monitor (ICM)"
11134031|NCT01779856|FG000|Participant Flow|REVEAL Insertable Cardiac Monitor (ICM)|Patients implanted with Medtronic Reveal XT or LINQ Device
11134032|NCT01779856|OG000|Outcome|REVEAL Insertable Cardiac Monitor (ICM)|Patients implanted with Medtronic Reveal XT or LINQ Device
11134033|NCT01779856|OG000|Outcome|Adverse Events|Study Subjects with Adverse Events
11134034|NCT01779856|OG000|Outcome|First 6 Months of Follow-up|Number of health care utilizations, by category, that occurred within the first 6 months of follow-up
11134035|NCT01779856|OG001|Outcome|All Available Time (up to 2 Years)|Number of health care utilizations, by category, that occurred within the course of the study.
11134036|NCT01779856|OG000|Outcome|Volume Removed 2.3|(L) volume removed during dialysis
11134037|NCT01779856|OG001|Outcome|Volume Removed 3.3|(L) volume removed during dialysis
11134038|NCT01779856|OG002|Outcome|Volume Removed 4.3|(L) volume removed during dialysis
11134039|NCT01779856|OG000|Outcome|ECG Recording Captured by the Reveal ICM Device|Patients implanted with Medtronic Reveal XT or LINQ Device
11134040|NCT01779856|EG000|Reported Event|REVEAL Insertable Cardiac Monitor (ICM)|"Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics.~REVEAL Insertable Cardiac Monitor (ICM)"
11134041|NCT01779869|BG000|Baseline|Single Group Assignment - Imaging|"All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.~Regadenoson: Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging."
11134042|NCT01779869|FG000|Participant Flow|Single Group Assignment - Imaging|"All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.~Regadenoson: Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging."
11134043|NCT01779869|OG000|Outcome|Single Group Assignment - Imaging|"All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.~Regadenoson: Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging."
11134044|NCT01779869|EG000|Reported Event|Single Group Assignment - Imaging|"All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.~Regadenoson: Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging."
11134045|NCT01780324|BG000|Baseline|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
11134046|NCT01780324|BG001|Baseline|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
11134047|NCT01780324|BG002|Baseline|Total|Total of all reporting groups
11134048|NCT01780324|FG000|Participant Flow|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
11134049|NCT01780324|FG001|Participant Flow|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
11134050|NCT01780324|OG000|Outcome|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
11134051|NCT01780324|OG001|Outcome|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
11134052|NCT01780324|EG000|Reported Event|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
11134053|NCT01780324|EG001|Reported Event|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
11134054|NCT01780337|BG000|Baseline|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
11134055|NCT01780337|BG001|Baseline|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
11134056|NCT01780337|BG002|Baseline|Total|Total of all reporting groups
11134057|NCT01780337|FG000|Participant Flow|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
10879680|NCT00459316|BG003|Baseline|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
10879681|NCT00459316|BG004|Baseline|Total|Total of all reporting groups
11134058|NCT01780337|FG001|Participant Flow|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
11134059|NCT01780337|OG000|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
11134060|NCT01780337|OG001|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
11134061|NCT01780337|EG000|Reported Event|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
11008778|NCT01098305|BG000|Baseline|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
11008779|NCT01098305|BG001|Baseline|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
11008780|NCT01098305|BG002|Baseline|Total|Total of all reporting groups
11008781|NCT01098305|FG000|Participant Flow|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
11008782|NCT01098305|FG001|Participant Flow|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
11008783|NCT01098305|OG000|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
11008784|NCT01098305|OG001|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
11008785|NCT01098305|EG000|Reported Event|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
11008786|NCT01098305|EG001|Reported Event|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
10849777|NCT00298155|EG002|Reported Event|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
11008787|NCT01098318|BG000|Baseline|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
11008788|NCT01098318|BG001|Baseline|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
11008789|NCT01098318|BG002|Baseline|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
11008790|NCT01098318|BG003|Baseline|Total|Total of all reporting groups
11008791|NCT01098318|FG000|Participant Flow|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
11008792|NCT01098318|FG001|Participant Flow|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
11008793|NCT01098318|FG002|Participant Flow|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
11008794|NCT01098318|OG000|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
11008795|NCT01098318|OG001|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
11008796|NCT01098318|OG002|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
11008797|NCT01098318|EG000|Reported Event|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
11134062|NCT01780337|EG001|Reported Event|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
11134063|NCT01780350|BG000|Baseline|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
11134064|NCT01780350|FG000|Participant Flow|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
11134065|NCT01780350|OG000|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
11134066|NCT01780350|EG000|Reported Event|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
11134067|NCT01780389|BG000|Baseline|Milnacipran|Open-label flexibly dosed milnacipran
11134068|NCT01780389|FG000|Participant Flow|Milnacipran|Open-label flexibly dosed milnacipran
11134069|NCT01780389|OG000|Outcome|Milnacipran-Open Label|"Open-label flexibly dosed milnacipran for 12 weeks. Twice-daily dosing will be used and the typical titration schedule will be as follows:~Day 1 - 12.5 mg every morning Day 2-3 - 12.5 mg twice a day Day 4-7 - 25 mg twice a day Day 8-84 - 50 mg twice a day~Taper:~Day 85-88 - 25 mg twice a day Day 89-92 - 12.5 twice a day Day 93-96 - 12.5 mg every morning"
11134070|NCT01780389|OG000|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
11134071|NCT01780389|EG000|Reported Event|Milnacipran|Open-label flexibly dosed milnacipran
11134072|NCT01780454|BG000|Baseline|Combined Bone Marrow and Kidney Transplantation|"Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation~MEDI-507: T-Cell Depleting Agent~Rituximab: B-Cell Depleting Agent~Total Body Irradiation: Bone Marrow Depletion~Thymic Irradiation"
11134073|NCT01780454|FG000|Participant Flow|Combined Bone Marrow and Kidney Transplantation|"Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation~MEDI-507: T-Cell Depleting Agent~Rituximab: B-Cell Depleting Agent~Total Body Irradiation: Bone Marrow Depletion~Thymic Irradiation"
10849778|NCT00298233|BG000|Baseline|Standarad Dose Oseltamivir|All participants that were randomized and received standard dose oseltamivir
10849779|NCT00298233|BG001|Baseline|Double Dose Oseltamivir|All participants that were randomized and received doubledose oseltamivir
10849780|NCT00298233|BG002|Baseline|Total|Total of all reporting groups
11134074|NCT01780454|OG000|Outcome|Combined Bone Marrow and Kidney Transplantation|"Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation~MEDI-507: T-Cell Depleting Agent~Rituximab: B-Cell Depleting Agent~Total Body Irradiation: Bone Marrow Depletion~Thymic Irradiation"
11134075|NCT01780454|EG000|Reported Event|Combined Bone Marrow and Kidney Transplantation|"Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation~MEDI-507: T-Cell Depleting Agent~Rituximab: B-Cell Depleting Agent~Total Body Irradiation: Bone Marrow Depletion~Thymic Irradiation"
11134076|NCT01780506|BG000|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
11134077|NCT01780506|BG001|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
11134078|NCT01780506|BG002|Baseline|Total|Total of all reporting groups
11134079|NCT01780506|FG000|Participant Flow|E/C/F/TAF|"Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) placebo tablet administered orally once daily for at least 144 weeks.~Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences terminated the study in that country."
11134080|NCT01780506|FG001|Participant Flow|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for at least 144 weeks.~Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences terminated the study in that country."
11134081|NCT01780506|OG000|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
11134082|NCT01780506|OG001|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
11134083|NCT01780506|EG000|Reported Event|Double-Blind: E/C/F/TAF|Adverse events reported in this group occurred during the Double-Blind Phase in participants who received E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks.
11134084|NCT01780506|EG001|Reported Event|Double-Blind: E/C/F/TDF|Adverse events reported in this group occurred during the Double-Blind Phase in participants who received E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.
11134085|NCT01780506|EG002|Reported Event|Open-Label: E/C/F/TAF to E/C/F/TAF|Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country.
11134086|NCT01780506|EG003|Reported Event|Open-Label: E/C/F/TDF to E/C/F/TAF|Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country.
11134087|NCT01780545|BG000|Baseline|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
11134088|NCT01780545|BG001|Baseline|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
11134089|NCT01780545|BG002|Baseline|Total|Total of all reporting groups
11134090|NCT01780545|FG000|Participant Flow|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
11134091|NCT01780545|FG001|Participant Flow|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
11134092|NCT01780545|OG000|Outcome|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
11134093|NCT01780545|OG001|Outcome|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
11134094|NCT01780545|OG000|Outcome|Hsp27 <5.7ng/mL|Subjects with a baseline Hsp27 level <5.7 ng/mL
11134095|NCT01780545|OG001|Outcome|Hsp27 >=5.7ng/mL|Subjects with a baseline Hsp27 level >=5.7 ng/mL
11134096|NCT01780545|OG000|Outcome|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle.~OGX-427: Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease"
11134097|NCT01780545|EG000|Reported Event|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
11134098|NCT01780545|EG001|Reported Event|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
11008798|NCT01098318|EG001|Reported Event|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
11134099|NCT01780584|BG000|Baseline|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
11134100|NCT01780584|BG001|Baseline|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
11134101|NCT01780584|BG002|Baseline|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
11134102|NCT01780584|BG003|Baseline|Total|Total of all reporting groups
11134103|NCT01780584|FG000|Participant Flow|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
11134104|NCT01780584|FG001|Participant Flow|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
11134105|NCT01780584|FG002|Participant Flow|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
11134106|NCT01780584|OG000|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
11134107|NCT01780584|OG001|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
11134108|NCT01780584|OG002|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
11134109|NCT01780584|EG000|Reported Event|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
11134110|NCT01780584|EG001|Reported Event|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
11134111|NCT01780584|EG002|Reported Event|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
11134112|NCT01780662|BG000|Baseline|Phase I Dose 1.4 mg/kg|Patients who were enrolled in Phase I and took dose 1.4mg/kg
11134113|NCT01780662|BG001|Baseline|Phase I Dose 1.8 mg/kg|Patients who were enrolled in Phase I and took dose 1.8mg/kg
11134114|NCT01780662|BG002|Baseline|Phase 2 Dose 1.8 mg/kg|Patients who were enrolled in Phase lI and took dose 1.8mg/kg
11134115|NCT01780662|BG003|Baseline|Total|Total of all reporting groups
11134116|NCT01780662|FG000|Participant Flow|Phase I, 1.4mg/kg|Patients who were enrolled in Phase I and took dose 1.4mg/kg
11134117|NCT01780662|FG001|Participant Flow|Phase I, 1.8mg/kg|Patients who were enrolled in Phase I and took dose 1.8mg/kg
11134118|NCT01780662|FG002|Participant Flow|Phase II, 1.8mg/kg|Patients who were enrolled in Phase lI and took dose 1.8mg/kg
11134119|NCT01780662|OG000|Outcome|Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)|"Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant.~Brentuximab Vedotin: Given IV~Gemcitabine Hydrochloride: Given IV"
11134120|NCT01780662|OG000|Outcome|Dose 1.4mg/kg (Phase I)|Patients who were enrolled in Phase I and took dose 1.4mg/kg
11134121|NCT01780662|OG001|Outcome|Dose 1.8mg/kg (Phase I + Phase II)|Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
11134122|NCT01780662|OG000|Outcome|Dose 1.8mg/kg|Evaluable patients who received dose 1.8mg/kg.
11134123|NCT01780662|OG000|Outcome|Dose 1.8mg/kg|Evaluable patients with received dose of 1.8mg/kg
11134124|NCT01780662|EG000|Reported Event|Dose1.4mg/kg|"Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant.~Brentuximab Vedotin: Given IV~Gemcitabine Hydrochloride: Given IV"
11134125|NCT01780662|EG001|Reported Event|Dose 1.8mg/kg|"Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant.~Brentuximab Vedotin: Given IV~Gemcitabine Hydrochloride: Given IV"
10849781|NCT00298233|FG000|Participant Flow|Standard Dose Oseltamivir Adult Cohort|All participants >= 15 years received standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
11134126|NCT01780831|BG000|Baseline|Cohort 1 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses of RAL: first dose (3 mg/kg or 2mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11149639|NCT01871805|EG001|Reported Event|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11134127|NCT01780831|BG001|Baseline|Cohort 1 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses of RAL: first dose (1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134128|NCT01780831|BG002|Baseline|Cohort 2 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL through 6 weeks of life starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134129|NCT01780831|BG003|Baseline|Cohort 2 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL through 6 weeks of life starting between 12 and 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134130|NCT01780831|BG004|Baseline|Total|Total of all reporting groups
11134131|NCT01780831|FG000|Participant Flow|Cohort 1 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses of RAL: first dose (3 mg/kg or 2mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134132|NCT01780831|FG001|Participant Flow|Cohort 1 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses of RAL: first dose (1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134133|NCT01780831|FG002|Participant Flow|Cohort 2 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134134|NCT01780831|FG003|Participant Flow|Cohort 2 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting between 12 and 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134135|NCT01780831|OG000|Outcome|Cohort 1 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses of RAL: first dose (3 mg/kg or 2mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134136|NCT01780831|OG001|Outcome|Cohort 1 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses of RAL: first dose (1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134137|NCT01780831|OG002|Outcome|Cohort 1 Total|"Full term Infants, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses of RAL: first dose (3 mg/kg, 2 mg/kg or 1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134138|NCT01780831|OG003|Outcome|Cohort 2 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL through 6 weeks of life starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134139|NCT01780831|OG004|Outcome|Cohort 2 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL through 6 weeks of life starting between 12 and 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134140|NCT01780831|OG005|Outcome|Cohort 2 Total|"Full term Infants, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL through 6 weeks of life starting within 48 hours of birth and between 12 to 60 hours of birth for in utero RAL-naive and RAL-exposed infants, respectively: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134141|NCT01780831|OG000|Outcome|Cohort 1 RAL-naive: 3 mg/kg for First Dose|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (3 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134142|NCT01780831|OG001|Outcome|Cohort 1 RAL-naive: 2 mg/kg for First Dose|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (2 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134143|NCT01780831|OG002|Outcome|Cohort 1 RAL-exposed 1.5 mg/kg|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134144|NCT01780831|OG000|Outcome|Cohort 1 RAL-naive: 3 mg/kg for First Dose|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses: first dose (3 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134145|NCT01780831|OG001|Outcome|Cohort 1 RAL-naive: 2 mg/kg for First Dose|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses: first dose (2 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134146|NCT01780831|OG002|Outcome|Cohort 1 RAL-exposed: 1.5 mg/kg for First Dose|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses: first dose (1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134147|NCT01780831|OG000|Outcome|Cohort 2 RAL-naive: 1.5 mg/kg Once Daily on Days 1-7 of Life|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of lifes starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134148|NCT01780831|OG001|Outcome|Cohort 2 RAL-exposed: 1.5mg/kg Once Daily on Days 1-7 of Life|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting between 12 and 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life"
11134149|NCT01780831|OG000|Outcome|Cohort 2 RAL-naive: 1.5 mg/kg Once Daily on Days 1-7 of Life|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134150|NCT01780831|OG001|Outcome|Cohort 2 RAL-exposed: 1.5 mg/kg Once Daily on Days 1-7 of Life|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting between 12 and 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134151|NCT01780831|OG000|Outcome|Cohort 2 RAL-naive: 3 mg/kg Twice Daily on Days 8-18 of Life|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134152|NCT01780831|OG001|Outcome|Cohort 2 RAL-exposed: 3 mg/kg Twice Daily on Days 8-28 of Life|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting between 12 to 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134153|NCT01780831|OG000|Outcome|Cohort 2 RAL-naive: 3 mg/kg Twice Daily on Days 8-28 of Life|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134154|NCT01780831|OG001|Outcome|Cohort 2 RAL-exposed: 3 mg/kg Twice Daily on Days 8-28 of Life|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting between 12 to 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life"
10849782|NCT00298233|FG001|Participant Flow|Double Dose Oseltamivir Adult Cohort|All Participants >= 15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
11134155|NCT01780831|OG000|Outcome|Cohort 1 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses: first dose (3 mg/kg or 2mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134156|NCT01780831|OG001|Outcome|Cohort 1 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses: first dose (1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134157|NCT01780831|OG002|Outcome|Cohort 1 Total|"Full term Infants, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single doses: first dose (3 mg/kg, 2 mg/kg or 1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11149640|NCT01871805|EG002|Reported Event|Alectinib 600 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11134158|NCT01780831|OG003|Outcome|Cohort 2 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134159|NCT01780831|OG004|Outcome|Cohort 2 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting between 12 to 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life"
11134160|NCT01780831|OG005|Outcome|Cohort 2 Total|"Full term Infants, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting within 48 hours of birth and between 12 to 60 hours of birth for in utero RAL-naive and RAL-exposed infants, respectively: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134161|NCT01780831|OG000|Outcome|Cohort 1 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (3 mg/kg or 2mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134162|NCT01780831|OG001|Outcome|Cohort 1 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134163|NCT01780831|OG002|Outcome|Cohort 1 Total|"Full term Infants, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (3 mg/kg, 2 mg/kg or 1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134164|NCT01780831|OG005|Outcome|Cohort 2 Total|"Full term Infants, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting within 48 hours of birth and between 12 to 60 hours of birth for RAL-naive and RAL-exposed infants, respectively: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134165|NCT01780831|OG000|Outcome|Cohort 1 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (3 mg/kg or 2 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134166|NCT01780831|OG004|Outcome|Cohort 2 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting between 12 to 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134167|NCT01780831|OG000|Outcome|(TA)6(TA)6|Cohort 1 infants whose UGT1A1 genotype were (TA)6(TA)6 (wildtype).
11134168|NCT01780831|OG001|Outcome|(TA)6(TA)7|Cohort 1 infants whose UGT1A1 genotype were (TA)6(TA)7.
11134169|NCT01780831|OG000|Outcome|(TA)6(TA)6 Wildtype|Cohort 2 infants whose UGT1A1 genotype were (TA)6(TA)6 (wildtype).
11134170|NCT01780831|OG001|Outcome|Mutation|Cohort 2 infants whose UGT1A1 genotype were mutation: (TA)5(TA)5, (TA)5(TA)6, (TA)5(TA)7, (TA)6(TA)7, or (TA)7(TA)7.
11134171|NCT01780831|OG000|Outcome|(TA)5(TA)6|Cohort 1 infants whose UGT1A1 genotype were (TA)5(TA)6.
11134172|NCT01780831|OG001|Outcome|(TA)6(TA)6|Cohort 1 infants whose UGT1A1 genotype were (TA)6(TA)6 (wildtype).
11134173|NCT01780831|OG002|Outcome|(TA)6(TA)7|Cohort 2 infants whose UGT1A1 genotype were (TA)6(TA)7.
11134174|NCT01780831|OG000|Outcome|(TA)6(TA)6|Cohort 2 infants whose UGT1A1 genotype were (TA)6(TA)6 (wildtype).
11134175|NCT01780831|OG001|Outcome|(TA)5(TA)5|Cohort 2 infants whose UGT1A1 genotype were (TA)5(TA)5.
11134176|NCT01780831|OG002|Outcome|(TA)5(TA)6|Cohort 2 infants whose UGT1A1 genotype were (TA)5(TA)6.
11134177|NCT01780831|OG003|Outcome|(TA)5(TA)7|Cohort 2 infants whose UGT1A1 genotype were (TA)5(TA)7.
11134178|NCT01780831|OG004|Outcome|(TA)6(TA)7|Cohort 2 infants whose UGT1A1 genotype were (TA)6(TA)7.
11134179|NCT01780831|OG005|Outcome|(TA)7(TA)7|Cohort 2 infants whose UGT1A1 genotype were (TA)7(TA)7.
11134180|NCT01780831|OG000|Outcome|C / C|Cohort 1 infants whose SLCO1B3 genotype were C/C (wildtype).
11134181|NCT01780831|OG001|Outcome|C / T|Cohort 1 infants whose SLCO1B3 genotype were C/T.
11134182|NCT01780831|OG002|Outcome|T / T|Cohorts infants whose SLCO1B3 genotype were T/T.
11134183|NCT01780831|OG000|Outcome|C / C|Cohort 2 infants whose SLCO1B3 genotype was C/C (wildtype).
11134184|NCT01780831|OG001|Outcome|C / T|Cohort 2 infants whose SLCO1B3 genotype was C/T.
11134185|NCT01780831|OG002|Outcome|T / T|Cohort 2 infants whose SLCO1B3 genotype was T/T.
11134186|NCT01780831|EG000|Reported Event|Cohort1 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (3 mg/kg or 2 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134187|NCT01780831|EG001|Reported Event|Cohort1 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: RAL was given as oral granules for suspension. Two single RAL doses: first dose (1.5 mg/kg) within 48 hours of birth and second dose (3 mg/kg) at 7-10 days of life."
11134188|NCT01780831|EG002|Reported Event|Cohort2 RAL-naive|"Full term Infants not exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting within 48 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134189|NCT01780831|EG003|Reported Event|Cohort2 RAL-exposed|"Full term Infants exposed in utero to maternal RAL, ≥2000 grams and ≥37 weeks gestational age at birth, born to women living with HIV-1 infection and at risk of acquiring HIV-1 infection.~Raltegravir: Daily RAL dosing through 6 weeks of life starting between 12 to 60 hours of birth: 1.5 mg/kg once daily during Days 1-7 of life, 3.0 mg/kg twice daily during Days 8-28 of life, and 6.0 mg/kg twice daily during Days 29-42 of life."
11134190|NCT01780870|BG000|Baseline|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
11134191|NCT01780870|BG001|Baseline|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
11134192|NCT01780870|BG002|Baseline|Total|Total of all reporting groups
11134193|NCT01780870|FG000|Participant Flow|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
11134194|NCT01780870|FG001|Participant Flow|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
11134195|NCT01780870|OG000|Outcome|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
11134196|NCT01780870|OG001|Outcome|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
11134197|NCT01780870|EG000|Reported Event|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
11134198|NCT01780870|EG001|Reported Event|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
11134199|NCT01780922|BG000|Baseline|All Study Participants|All study participants: all participants received all interventions
11134200|NCT01780922|FG000|Participant Flow|LCJC First, Then CLEB, Then Placebo|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
11134201|NCT01780922|FG001|Participant Flow|LCJC First, Then Placebo, Then CLEB|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
11134202|NCT01780922|FG002|Participant Flow|CLEB First, Then LCJC, Then Placebo|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
11134203|NCT01780922|FG003|Participant Flow|CLEB First, Then Placebo, Then LCJC|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
11134204|NCT01780922|FG004|Participant Flow|Placebo First, Then LCJC, Then CLEB|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
11134205|NCT01780922|FG005|Participant Flow|Placebo First, Then CLEB, Then LCJC|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
11134206|NCT01780922|OG000|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
11134207|NCT01780922|OG001|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
11134208|NCT01780922|OG002|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
11134209|NCT01780922|EG000|Reported Event|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
11134210|NCT01780922|EG001|Reported Event|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
11134211|NCT01780922|EG002|Reported Event|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
11134212|NCT01780935|BG000|Baseline|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
11134213|NCT01780935|BG001|Baseline|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
11134214|NCT01780935|BG002|Baseline|Total|Total of all reporting groups
11134215|NCT01780935|FG000|Participant Flow|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
11134216|NCT01780935|FG001|Participant Flow|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
11134217|NCT01780935|OG000|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
11134218|NCT01780935|OG001|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
11134219|NCT01780935|EG000|Reported Event|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
11134220|NCT01780935|EG001|Reported Event|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
11134221|NCT01780974|BG000|Baseline|Placebo|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
11134222|NCT01780974|BG001|Baseline|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
11134223|NCT01780974|BG002|Baseline|Total|Total of all reporting groups
11134224|NCT01780974|FG000|Participant Flow|Placebo|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
11134225|NCT01780974|FG001|Participant Flow|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
11134226|NCT01780974|OG000|Outcome|Placebo|"Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.~Placebo: placebo capsules"
11134227|NCT01780974|OG001|Outcome|Lipoic Acid Plus Omega-3 Fatty Acids|"Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.~Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate"
11134228|NCT01780974|EG000|Reported Event|Placebo|placebo capsules
11134229|NCT01780974|EG001|Reported Event|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
11134230|NCT01780987|BG000|Baseline|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
11134231|NCT01780987|BG001|Baseline|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
11134232|NCT01780987|BG002|Baseline|Total|Total of all reporting groups
11134233|NCT01780987|FG000|Participant Flow|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
11134234|NCT01780987|FG001|Participant Flow|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
11134235|NCT01780987|OG000|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
11134236|NCT01780987|OG001|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
11134237|NCT01780987|EG000|Reported Event|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
11134238|NCT01780987|EG001|Reported Event|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
11134239|NCT01781078|BG000|Baseline|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
11134240|NCT01781078|BG001|Baseline|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
11134241|NCT01781078|BG002|Baseline|Total|Total of all reporting groups
11134242|NCT01781078|FG000|Participant Flow|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
11134243|NCT01781078|FG001|Participant Flow|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
11134244|NCT01781078|FG002|Participant Flow|Patients Withdrawn Prior to Randomization|Patients who consented to the study but were withdrawn prior to the randomization.
11134245|NCT01781078|OG000|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
11134246|NCT01781078|OG001|Outcome|Control Group|"Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
11134247|NCT01781078|OG000|Outcome|Control Group|"Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
11134248|NCT01781078|OG001|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
11134249|NCT01781078|OG000|Outcome|All Subjects Who Underwent an Implant Procedure|All subjects who underwent an implant procedure and reached 91 days of follow-up.
11134250|NCT01781078|EG000|Reported Event|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
11134251|NCT01781078|EG001|Reported Event|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
11134252|NCT01781169|BG000|Baseline|Normal-weight Group|
11134253|NCT01781169|BG001|Baseline|Obese Group|
11134254|NCT01781169|BG002|Baseline|Total|Total of all reporting groups
11134255|NCT01781169|FG000|Participant Flow|Obese Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
11134256|NCT01781169|FG001|Participant Flow|Normal-weight Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
11134257|NCT01781169|OG000|Outcome|Obese Group|Oral supplementation of vitamin D.
11134258|NCT01781169|OG001|Outcome|Normal-weight Group|Oral supplementation of vitamin D.
11134259|NCT01781169|EG000|Reported Event|Normal-weight Group|
11134260|NCT01781169|EG001|Reported Event|Obese Group|
11008799|NCT01098318|EG002|Reported Event|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
11134261|NCT01781208|BG000|Baseline|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy for known or suspected (non-neoplastic) liver disease were included in this study. Subjects were between 0-18 years of age.
11134262|NCT01781208|FG000|Participant Flow|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|"62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy were included. Biopsy was performed for known or suspected (non-neoplastic) liver disease. (One child did not undergo a liver biopsy, so was ineligible and not included in the above total.)~The patients received an additional ultrasound for research purposes that utilized a technique known as ARFI. ARFI, or Acoustic Radiation Force Impulse, uses a transducer which directs sound waves again the liver to measure the stiffness of the tissues."
11134263|NCT01781208|OG000|Outcome|Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI (VTQ) and liver histologic fibrosis score.
11134264|NCT01781208|OG001|Outcome|Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI/VTIQ and liver histologic fibrosis score.
11134265|NCT01781208|EG000|Reported Event|All Participants|No serious or non-serious adverse events were observed during the study.
11134266|NCT01781234|BG000|Baseline|Intranasal Insulin|Group receiving active treatment
11134267|NCT01781234|BG001|Baseline|Placebo|Group receiving placebo
11134268|NCT01781234|BG002|Baseline|Total|Total of all reporting groups
10849783|NCT00298233|FG002|Participant Flow|Standard Dose Oseltamivir Child Cohort|All participants <15 years received standard dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
11134269|NCT01781234|FG000|Participant Flow|Intranasal Insulin|Group receiving active treatment
11134270|NCT01781234|FG001|Participant Flow|Placebo|Group receiving placebo
11134271|NCT01781234|OG000|Outcome|Intranasal Insulin|"Intranasal Insulin~Intranasal Insulin"
11134272|NCT01781234|OG001|Outcome|Placebo|"Placebo~Placebo"
11134273|NCT01781234|OG000|Outcome|Intranasal Insulin|Group receiving active treatment
11134274|NCT01781234|OG001|Outcome|Placebo|Group receiving placebo
11134275|NCT01781234|EG000|Reported Event|Intranasal Insulin|Group receiving active treatment
11134276|NCT01781234|EG001|Reported Event|Placebo|Group receiving placebo
11134277|NCT01781286|BG000|Baseline|All Study Participants|Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); and 3) No Snack. On day 4, participants completed all testing day procedures outlined in the study description.
11134278|NCT01781286|FG000|Participant Flow|High Fat Snack > No Snack > High Protein Snack|8 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); 2) No Snack and 3) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures.
11134279|NCT01781286|FG001|Participant Flow|High Fat Snack > High Protein Snack > No Snack|4 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); 2) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat) and 3) No Snack. On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures.
11134280|NCT01781286|FG002|Participant Flow|No Snack > High Protein Snack > High Fat Snack|9 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) No Snack; 2) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat) and 3) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures.
11134281|NCT01781286|FG003|Participant Flow|No Snack > High Fat Snack > High Protein Snack|8 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) No Snack; 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat and 3) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures.
11134282|NCT01781286|FG004|Participant Flow|High Protein Snack > No Snack > High Fat Snack|6 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) No Snack and 3) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat. On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures.
11134283|NCT01781286|FG005|Participant Flow|High Protein Snack > High Fat Snack > No Snack|3 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat and 3) No Snack. On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures.
11134284|NCT01781286|OG000|Outcome|High Protein|"Higher Protein Soy-based Snacks~High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat"
11134285|NCT01781286|OG001|Outcome|High Fat (Low Protein)|"Typical High Fat (Low Protein) Snacks~5% Protein; 50% Carbohydrates; 45% Fat"
11134286|NCT01781286|OG002|Outcome|No Snack|No snack was received
11134287|NCT01781286|OG001|Outcome|High Fat (Low Protein)|"Typical, High Fat (Low Protein) Snacks~5% Protein; 50% Carbohydrates; 45% Fat"
11134288|NCT01781286|OG002|Outcome|No Snack|No snack was received (0 kJ)
11134289|NCT01781286|EG000|Reported Event|High Protein|"Higher Protein Soy-based Snacks~High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat"
11134290|NCT01781286|EG001|Reported Event|Low Protein|"Typical, Low Protein Snacks~Low Protein: 5% Protein; 50% Carbohydrates; 45% Fat"
11134291|NCT01781286|EG002|Reported Event|No Snack|No snack was received (0 kJ)
11134292|NCT01781299|BG000|Baseline|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
11134293|NCT01781299|BG001|Baseline|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
11134294|NCT01781299|BG002|Baseline|Total|Total of all reporting groups
11134295|NCT01781299|FG000|Participant Flow|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
11134296|NCT01781299|FG001|Participant Flow|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
11134297|NCT01781299|OG000|Outcome|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
11134298|NCT01781299|OG001|Outcome|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
11134299|NCT01781299|EG000|Reported Event|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
11134300|NCT01781299|EG001|Reported Event|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
11134301|NCT01781403|BG000|Baseline|Capecitabine, Temozolomide, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
11134302|NCT01781403|FG000|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 45mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
11134303|NCT01781403|FG001|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 60mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
11134304|NCT01781403|FG002|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 75mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
11134305|NCT01781403|OG000|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
11134306|NCT01781403|OG001|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
11134307|NCT01781403|OG002|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
11134308|NCT01781403|OG000|Outcome|Unmethylated MGMT|MGMT methylation specific PCR: unmethlyated
11134309|NCT01781403|OG001|Outcome|Hypermethylated MGMT|MGMT methylation specific PCR: hypermethylated
11134310|NCT01781403|EG000|Reported Event|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
11134311|NCT01781403|EG001|Reported Event|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
11134312|NCT01781403|EG002|Reported Event|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
11134313|NCT01781429|BG000|Baseline|Dose-escalation 10mg b.i.d. Cohort|"Patients received 10mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134314|NCT01781429|BG001|Baseline|Dose-escalation 20mg b.i.d. Cohort|"Patients received 20mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134315|NCT01781429|BG002|Baseline|Dose-escalation 40mg b.i.d. Cohort|"Patients received 40mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134316|NCT01781429|BG003|Baseline|Dose-escalation 75mg b.i.d. Cohort|"Patients received 75mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134317|NCT01781429|BG004|Baseline|Dose-escalation 150mg b.i.d. Cohort|"Patients received 150mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134318|NCT01781429|BG005|Baseline|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134319|NCT01781429|BG006|Baseline|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134320|NCT01781429|BG007|Baseline|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134321|NCT01781429|BG008|Baseline|Dose-escalation 900mg b.i.d. Cohort|"Patients received 900mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134322|NCT01781429|BG009|Baseline|Cohort-expansion Group 1|"Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134323|NCT01781429|BG010|Baseline|Cohort-expansion Group 2|"Patients with BRAF mutated colorectal cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11149641|NCT01871805|EG003|Reported Event|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11134324|NCT01781429|BG011|Baseline|Cohort-expansion Group 3|"Patients with BRAF mutated melanoma who had progressed or were refractory to BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134325|NCT01781429|BG012|Baseline|Cohort-expansion Group 4|"Patients with NRAS mutated melanoma, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134326|NCT01781429|BG013|Baseline|Cohort-expansion Group 5|"Patients with MEK mutated cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134327|NCT01781429|BG014|Baseline|Cohort-expansion Group 6|"Patients with BRAF mutated non-small cell lung cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134328|NCT01781429|BG015|Baseline|Total|Total of all reporting groups
11134329|NCT01781429|FG000|Participant Flow|Dose-escalation 10mg b.i.d. Cohort|"Patients received 10mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134330|NCT01781429|FG001|Participant Flow|Dose-escalation 20mg b.i.d. Cohort|"Patients received 20mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134331|NCT01781429|FG002|Participant Flow|Dose-escalation 40mg b.i.d. Cohort|"Patients received 40mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134332|NCT01781429|FG003|Participant Flow|Dose-escalation 75mg b.i.d. Cohort|"Patients received 75mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134333|NCT01781429|FG004|Participant Flow|Dose-escalation 150mg b.i.d. Cohort|"Patients received 150mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134334|NCT01781429|FG005|Participant Flow|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134335|NCT01781429|FG006|Participant Flow|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134336|NCT01781429|FG007|Participant Flow|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134337|NCT01781429|FG008|Participant Flow|Dose-escalation 900mg b.i.d. Cohort|"Patients received 900mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134338|NCT01781429|FG009|Participant Flow|Cohort-expansion Group 1|"Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134339|NCT01781429|FG010|Participant Flow|Cohort-expansion Group 2|"Patients with BRAF mutated colorectal cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134340|NCT01781429|FG011|Participant Flow|Cohort-expansion Group 3|"Patients with BRAF mutated melanoma who had progressed or were refractory to BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134341|NCT01781429|FG012|Participant Flow|Cohort-expansion Group 4|"Patients with NRAS mutated melanoma, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134342|NCT01781429|FG013|Participant Flow|Cohort-expansion Group 5|"Patients with MEK mutated cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134343|NCT01781429|FG014|Participant Flow|Cohort-expansion Group 6|"Patients with BRAF mutated non-small cell lung cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134344|NCT01781429|FG015|Participant Flow|Cohort-expansion Group 7|"Patients with ERK mutated cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134345|NCT01781429|OG000|Outcome|Dose-escalation 10mg b.i.d. Cohort|"Patients received 10mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134346|NCT01781429|OG001|Outcome|Dose-escalation 20mg b.i.d. Cohort|"Patients received 20mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134347|NCT01781429|OG002|Outcome|Dose-escalation 40mg b.i.d. Cohort|"Patients received 40mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134348|NCT01781429|OG003|Outcome|Dose-escalation 75mg b.i.d. Cohort|"Patients received 75mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134349|NCT01781429|OG004|Outcome|Dose-escalation 150mg b.i.d. Cohort|"Patients received 150mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134350|NCT01781429|OG005|Outcome|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
10849784|NCT00298233|FG003|Participant Flow|Double Dose Oseltamivir Child Cohort|All Participants <15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
10849785|NCT00298233|OG000|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
11134351|NCT01781429|OG006|Outcome|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134352|NCT01781429|OG007|Outcome|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134353|NCT01781429|OG008|Outcome|Dose-escalation 900mg b.i.d. Cohort|"Patients received 900mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134354|NCT01781429|OG009|Outcome|Cohort-expansion Group 1|"Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134355|NCT01781429|OG010|Outcome|Cohort-expansion Group 2|"Patients with BRAF mutated colorectal cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134356|NCT01781429|OG011|Outcome|Cohort-expansion Group 3|"Patients with BRAF mutated melanoma who had progressed or were refractory to BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134357|NCT01781429|OG012|Outcome|Cohort-expansion Group 4|"Patients with NRAS mutated melanoma, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134358|NCT01781429|OG013|Outcome|Cohort-expansion Group 5|"Patients with MEK mutated cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134359|NCT01781429|OG014|Outcome|Cohort-expansion Group 6|"Patients with BRAF mutated non-small cell lung cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134360|NCT01781429|OG000|Outcome|Cohort-expansion Group 1|"Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134361|NCT01781429|OG001|Outcome|Cohort-expansion Group 2|"Patients with BRAF mutated colorectal cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134362|NCT01781429|OG002|Outcome|Cohort-expansion Group 3|"Patients with BRAF mutated melanoma who had progressed or were refractory to BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134363|NCT01781429|OG003|Outcome|Cohort-expansion Group 4|"Patients with NRAS mutated melanoma, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134364|NCT01781429|OG004|Outcome|Cohort-expansion Group 5|"Patients with MEK mutated cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134365|NCT01781429|OG005|Outcome|Cohort-expansion Group 6|"Patients with BRAF mutated non-small cell lung cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
10849786|NCT00298233|OG001|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
11134366|NCT01781429|EG000|Reported Event|Dose-escalation 10mg b.i.d. Cohort|"Patients received 10mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134367|NCT01781429|EG001|Reported Event|Dose-escalation 20mg b.i.d. Cohort|"Patients received 20mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134368|NCT01781429|EG002|Reported Event|Dose-escalation 40mg b.i.d. Cohort|"Patients received 40mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks"
11134369|NCT01781429|EG003|Reported Event|Dose-escalation 75mg b.i.d. Cohort|"Patients received 75mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134370|NCT01781429|EG004|Reported Event|Dose-escalation 150mg b.i.d. Cohort|"Patients received 150mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134371|NCT01781429|EG005|Reported Event|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134372|NCT01781429|EG006|Reported Event|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134373|NCT01781429|EG007|Reported Event|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134374|NCT01781429|EG008|Reported Event|Dose-escalation 900mg b.i.d. Cohort|"Patients received 900mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks."
11134375|NCT01781429|EG009|Reported Event|Cohort-expansion|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11134376|NCT01781468|BG000|Baseline|Arm I (150 mg Armodafinil)|Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
11134377|NCT01781468|BG001|Baseline|Arm II (250 mg Armodafinil)|Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
11134378|NCT01781468|BG002|Baseline|Arm III (Placebo)|Patients receive placebo orally every day in the morning for 8 weeks.
11134379|NCT01781468|BG003|Baseline|Total|Total of all reporting groups
11134380|NCT01781468|FG000|Participant Flow|Arm I (150 mg Armodafinil)|Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
11134381|NCT01781468|FG001|Participant Flow|Arm II (250 mg Armodafinil)|Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
11134382|NCT01781468|FG002|Participant Flow|Arm III (Placebo)|Patients receive placebo orally every day in the morning for 8 weeks.
10849787|NCT00298233|EG000|Reported Event|Double Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
11134383|NCT01781468|OG000|Outcome|Arm I (150 mg Armodafinil)|Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
11134384|NCT01781468|OG001|Outcome|Arm II (250 mg Armodafinil)|Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
11134385|NCT01781468|OG002|Outcome|Arm III (Placebo)|Patients receive placebo orally every day in the morning for 8 weeks.
11134386|NCT01781468|OG001|Outcome|Arm II (250 mg Armodafinil)|Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks.
11134387|NCT01781468|EG000|Reported Event|Arm I (150 mg Armodafinil)|Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
11134388|NCT01781468|EG001|Reported Event|Arm II (250 mg Armodafinil)|Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks.
11134389|NCT01781468|EG002|Reported Event|Arm III (Placebo)|Patients receive placebo orally every day in the morning for 8 weeks.
11134390|NCT01781481|BG000|Baseline|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
11134391|NCT01781481|FG000|Participant Flow|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).
11134392|NCT01781481|OG000|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
11134393|NCT01781481|OG000|Outcome|Biological|Sum of Biological Domain Item Scores
11134394|NCT01781481|OG001|Outcome|Psychological|Sum of Psychological Domain Item Scores
11134395|NCT01781481|OG002|Outcome|Social|Sum of Social Domain Item Scores
11134396|NCT01781481|OG003|Outcome|Family/Caregiver|Sum of Family/Caregiver Domain Item Scores
11134397|NCT01781481|OG004|Outcome|Health Service|Sum of Health Service Domain Item Scores
11134398|NCT01781481|OG000|Outcome|Score of 0|Rating of 0 (No Vulnerability/Need for Action) on Pediatric INTERMED Item
11134399|NCT01781481|OG001|Outcome|Score of 1|Rating of 1 (Mild Vulnerability/Need for watchful waiting or preventive intervention) on Pediatric INTERMED item.
11134400|NCT01781481|OG002|Outcome|Score of 2 or 3|Rating of 2 (Moderate Vulnerability/Need for Action or Development of an Intervention Plan) on the Pediatric INTERMED item or Rating of 3 (Severe Vulnerability/Need for Immediate Action of Intensive Action/Plans).
11134401|NCT01781481|OG000|Outcome|Disease Severity: Remission/Inactive|Disease Severity classified as in remission/inactive
11134402|NCT01781481|OG001|Outcome|Disease Severity: Mild|Disease Severity classified as mild
11134403|NCT01781481|OG002|Outcome|Disease Severity: Moderate|Disease Severity classified as moderate
11134404|NCT01781481|OG003|Outcome|Disease Severity: Severe|Disease Severity classified as severe
11134405|NCT01781481|OG000|Outcome|Less Than 6 Months|Less than 6 months since initial IBD diagnosis.
11134406|NCT01781481|OG001|Outcome|6 Months-1 Year|6 months to 1 year since initial IBD diagnosis.
11134407|NCT01781481|OG002|Outcome|1 Year-5 Years|1 - 5 years since initial IBD diagnosis.
11134408|NCT01781481|OG003|Outcome|Greater Than 5 Years|Greater than 5 years since initial IBD diagnosis.
11134409|NCT01781481|OG000|Outcome|Children/Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
11134410|NCT01781481|OG000|Outcome|Pediatric INTERMED Biological Domain Score|Sum of all Pediatric INTERMED Biological domain item scores.
11134411|NCT01781481|OG001|Outcome|Historical Biological Item: Chronicity|This item taps the extent and chronicity of child's physical health issues.
11134412|NCT01781481|OG002|Outcome|Historical Biological Item: Diagnostic Dilemma|This item taps whether or not the child/youth has been seeking care for physical complaints across a substantial portion of their life and whether or not these complaints have been resolved.
11134413|NCT01781481|OG003|Outcome|Current Biological Item: Symptom Severity|This item taps the severity/acuity of the child's current physical symptoms, and the extent to which they impact on current functioning.
11134414|NCT01781481|OG004|Outcome|Current Biological Item: Diagnostic/Therapeutic Challenge|This item refers to the presence of physical symptoms that result in current diagnostic questions or therapeutic challenges.
11134415|NCT01781481|OG005|Outcome|Current Biological Item: Therapeutic Complexity|This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.
11134416|NCT01781481|OG006|Outcome|Vulnerability Biological Item: Complications and Life Threat|This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
11134417|NCT01781481|OG000|Outcome|Pediatric INTERMED Psychological Domain Score|Sum of Pediatric INTERMED Psychological Domain item scores
11134418|NCT01781481|OG001|Outcome|Pediatric INTERMED Social Domain Score|Sum of Pediatric INTERMED Social Domain items scores
11134419|NCT01781481|OG002|Outcome|Pediatric INTERMED Caregiver/Family Domain Score|Sum of Pediatric INTERMED Caregiver/Family Domain item scores
11134420|NCT01781481|OG000|Outcome|Subjects With MASC Scores in the Clinical Range.|Children whose scores on the Multidimensional Anxiety Scale for Children fell within the clinical range.
11134421|NCT01781481|OG001|Outcome|Subjects With MASC Scores in the Non-clinical Range|Children whose scores on the Multidimensional Anxiety Scale for Children fell below the clinical range.
11134422|NCT01781481|OG000|Outcome|Subjects With CDI Scores in the Clinical Range.|Children whose scores on the Children's Depression Inventory fell within the clinical range.
11134423|NCT01781481|OG001|Outcome|Subjects With CDI Scores in the Non-clinical Range|Children whose scores on the Children's Depression Inventory fell below the clinical range.
11134424|NCT01781481|OG000|Outcome|CBCL Internalizing Score in the Clinical Range.|Children whose scores on the CBCL Internalizing Scale fell within the clinical range.
11134425|NCT01781481|OG001|Outcome|CBCL Internalizing Score in the Non-clinical Range|Children's whose scores on the CBCL Internalizing Scale fell below the clinical range.
11134426|NCT01781481|OG000|Outcome|CBCL Externalizing Score in the Clinical Range.|Children whose scores on the CBCL Externalizing scale fell within the clinical range.
11134427|NCT01781481|OG001|Outcome|CBCL Externalizing Score in the Non-clinical Range|Children whose scores on the CBCL Externalizing Scale fell below the clinical range.
11134428|NCT01781481|OG000|Outcome|Pediatric Intermed: Health System Domain Score|Sum of Pediatric INTERMED health system item scores.
11134429|NCT01781481|OG001|Outcome|Historical Health System Item: Access to Health Care|This item refers to anything in the past that served as an obstacle, hindering the patient's access to healthcare.
11134430|NCT01781481|OG002|Outcome|Historical Health System Item: Treatment Experience|This item describes the degree to which the child and family's prior health care experiences have been positive in terms of good outcomes and relationships with health care providers.
11134431|NCT01781481|OG003|Outcome|Current Health System Item: Organization of Care|This item describes the nature and organization of the health care services that the child is current receiving.
11134432|NCT01781481|OG004|Outcome|Current Health System Item: Coordination of Care|This item describes the extent to which the different health care providers working with the child are in contact with each other.
11134433|NCT01781481|OG005|Outcome|Vulnerability Health System Item: Health System Impediments|This item anticipates the problems that the child/youth may encounter in the next 3-6 months in receiving the services he/she requires.
11134434|NCT01781481|EG000|Reported Event|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
11134435|NCT01781572|BG000|Baseline|Phase 1b 28-Day MEK162 45mg + LEE011 200mg|MEK162 45mg + LEE011 200mg
11134436|NCT01781572|BG001|Baseline|Phase 1b 28-Day MEK162 45mg+LEE011 250mg|MEK162 45mg+LEE011 250mg
11134437|NCT01781572|BG002|Baseline|Phase 1b 28-Day MEK162 30mg+LEE011 300mg|MEK162 30mg+LEE011 300mg
11134438|NCT01781572|BG003|Baseline|Phase 1b 28-Day MEK162 45mg+LEE011 300mg|MEK162 45mg+LEE011 300mg
11134439|NCT01781572|BG004|Baseline|Phase 1b 21-Day MEK162 30mg+LEE011 200mg|MEK162 30mg+LEE011 200mg
11134440|NCT01781572|BG005|Baseline|Phase 1b 21-Day MEK162 45mg+LEE011 200mg|MEK162 45mg+LEE011 200mg
11134441|NCT01781572|BG006|Baseline|Phase 1b 21-Day MEK162 30mg+LEE011 300mg|MEK162 30mg+LEE011 300mg
11134442|NCT01781572|BG007|Baseline|Phase 1b 21-Day MEK162 45mg+LEE011 300mg|MEK162 45mg+LEE011 300mg
11134443|NCT01781572|BG008|Baseline|Phase 1b 21-Day MEK162 45mg+LEE011 450mg|MEK162 45mg+LEE011 450mg
11134444|NCT01781572|BG009|Baseline|Phase 1b 21-Day MEK162 45mg+LEE011 600mg|MEK162 45mg+LEE011 600mg
11134445|NCT01781572|BG010|Baseline|Phase 2: MEK162 45mg+LEE011 200mg|MEK162 45mg+LEE011 200mg
11134446|NCT01781572|BG011|Baseline|Total|Total of all reporting groups
11134447|NCT01781572|FG000|Participant Flow|Phase 1b 28-Day Schedule|"A combined total of 61 patients were treated in the 28-day (n=29) and 21-day (n=32) treatment cycles, and all patients discontinued treatment. The starting dose in the 28-day schedule was binimetinib 45 mg BID + ribociclib 200 mg QD.~28-Day Schedule: ribociclib was taken QD for 21 consecutive days followed by a 7-day planned break.~Binimetinib was taken BID on a continuous dosing schedule."
11134448|NCT01781572|FG001|Participant Flow|Phase 1b 21-Day Schedule|"A combined total of 61 patients were treated in the 28-day (n=29) and 21-day (n=32) treatment cycles, and all patients discontinued treatment. The starting dose in the 21-day schedule was binimetinib 30 mg BID + ribociclib 200 mg QD.~21-Day Schedule: ribociclib QD and binimetinib BID were taken QD for 14 consecutive days followed by a 7-day planned break."
11134449|NCT01781572|FG002|Participant Flow|Phase 2 (Dose-expansion Phase)|"The dose-expansion phase was initiated with a newly recruited group of patients.~A total of 41 patients were treated, and all patients (100%) discontinued treatment. Based on the recommendations of the dose-escalation meetings between the Sponsor and the Investigators, the RP2D and schedule for the combination of binimetinib and ribociclib to be used for the dose-expansion phase of the study was binimetinib 45 mg BID + ribociclib 200 mg QD on the 28-day schedule."
11134450|NCT01781572|OG000|Outcome|Phase 1b 28-Day MEK162 45mg + LEE011 200mg|MEK162 45mg + LEE011 200mg
11134451|NCT01781572|OG001|Outcome|Phase 1b 28-Day MEK162 45mg+LEE011 250mg|MEK162 45mg+LEE011 250mg
11134452|NCT01781572|OG002|Outcome|Phase 1b 28-Day MEK162 30mg+LEE011 300mg|MEK162 30mg+LEE011 300mg
11134453|NCT01781572|OG003|Outcome|Phase 1b 28-Day MEK162 45mg+LEE011 300mg|MEK162 45mg+LEE011 300mg
11134454|NCT01781572|OG004|Outcome|Phase 1b 21-Day MEK162 30mg+LEE011 200mg|MEK162 30mg+LEE011 200mg
11134455|NCT01781572|OG005|Outcome|Phase 1b 21-Day MEK162 45mg+LEE011 200mg|MEK162 45mg+LEE011 200mg
11134456|NCT01781572|OG006|Outcome|Phase 1b 21-Day MEK162 30mg+LEE011 300mg|MEK162 30mg+LEE011 300mg
11134457|NCT01781572|OG007|Outcome|Phase 1b 21-Day MEK162 45mg+LEE011 300mg|MEK162 45mg+LEE011 300mg
11134458|NCT01781572|OG008|Outcome|Phase 1b 21-Day MEK162 45mg+LEE011 450mg|MEK162 45mg+LEE011 450mg
11134459|NCT01781572|OG009|Outcome|Phase 1b 21-Day MEK162 45mg+LEE011 600mg|MEK162 45mg+LEE011 600mg
11134460|NCT01781572|OG000|Outcome|Phase 2: Dose Expansion|binimetinib 45 mg BID + ribociclib 200 mg QD (MEK 45mg + LEE 200mg)
11134461|NCT01781572|OG010|Outcome|Phase 2: MEK162 45mg+LEE011 200mg|MEK162 45mg+LEE011 200mg
11134462|NCT01781572|OG000|Outcome|Phase 2: Dose Expansion|"The dose-expansion phase was initiated with a newly recruited group of patients.~Binimetinib 45 mg BID + ribociclib 200 mg QD on 28-day schedule"
11134463|NCT01781572|OG000|Outcome|Phase 1b 28-Day Schedule|"A combined total of 61 patients were treated in the 28-day (n=29) and 21-day (n=32) treatment cycles, and all patients discontinued treatment. The starting dose in the 28-day schedule was binimetinib 45 mg BID + ribociclib 200 mg QD.~28-Day Schedule: ribociclib was taken QD for 21 consecutive days followed by a 7-day planned break.~Binimetinib was taken BID on a continuous dosing schedule."
11134464|NCT01781572|OG001|Outcome|Phase 1b 21-Day Schedule|"A combined total of 61 patients were treated in the 28-day (n=29) and 21-day (n=32) treatment cycles, and all patients discontinued treatment. The starting dose in the 21-day schedule was binimetinib 30 mg BID + ribociclib 200 mg QD.~21-Day Schedule: ribociclib QD and binimetinib BID were taken QD for 14 consecutive days followed by a 7-day planned break."
11134465|NCT01781572|OG002|Outcome|Phase 2 (Dose-expansion Phase)|"The dose-expansion phase was initiated with a newly recruited group of patients.~A total of 41 patients were treated, and all patients (100%) discontinued treatment. Based on the recommendations of the dose-escalation meetings between the Sponsor and the Investigators, the RP2D and schedule for the combination of binimetinib and ribociclib to be used for the dose-expansion phase of the study was binimetinib 45 mg BID + ribociclib 200 mg QD on the 28-day schedule."
11134466|NCT01781572|EG000|Reported Event|Phase 1b - 28 Day MEK162 45mg+LEE011 200mg|MEK162 45mg BID+LEE011 200mg QD
11134467|NCT01781572|EG001|Reported Event|Phase 1b - 28 Day MEK162 45mg+LEE011 250mg|MEK162 45mg BID+LEE011 250mg QD
11134468|NCT01781572|EG002|Reported Event|Phase 1b - 28 Day MEK162 30mg+LEE011 300mg|MEK162 30mg BID+LEE011 300mg QD
11134469|NCT01781572|EG003|Reported Event|Phase 1b - 28 Day MEK162 45mg+LEE011 300mg|MEK162 45mg BID+LEE011 300mg QD
11134470|NCT01781572|EG004|Reported Event|Phase 1b - 21 Day MEK162 30mg+LEE011 200mg|MEK162 30mg BID+LEE011 200mg QD
11134471|NCT01781572|EG005|Reported Event|Phase 1b - 21 Day MEK162 45mg+LEE011 200mg|MEK162 45mg BID+LEE011 200mg QD
11134472|NCT01781572|EG006|Reported Event|Phase 1b - 21 Day MEK162 30mg+LEE011 300mg|MEK162 30mg BID+LEE011 300mg QD
11134473|NCT01781572|EG007|Reported Event|Phase 1b - 21 Day MEK162 45mg+LEE011 300mg|MEK162 45mg BID+LEE011 300mg QD
11134474|NCT01781572|EG008|Reported Event|Phase 1b - 21 Day MEK162 45mg+LEE011 450mg|MEK162 45mg BID+LEE011 450mg QD
11134475|NCT01781572|EG009|Reported Event|Phase 1b - 21 Day MEK162 45mg+LEE011 600mg|MEK162 45mg BID+LEE011 600mg QD
11134476|NCT01781572|EG010|Reported Event|Phase 2 - Dose Expansion Phase|"The dose-expansion phase was initiated with a newly recruited group of patients.~Binimetinib 45 mg BID + ribociclib 200 mg QD on 28-day schedule"
11134477|NCT01781611|BG000|Baseline|Extended Release Dipyridamole/Aspirin|"extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks~extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks"
11134478|NCT01781611|BG001|Baseline|Aspirin|"half a tablet of a 81mg aspirin twice daily for 24 weeks~81mg aspirin: half a tablet twice daily for 24 weeks"
11134479|NCT01781611|BG002|Baseline|Total|Total of all reporting groups
11134480|NCT01781611|FG000|Participant Flow|Extended Release Dipyridamole/Aspirin|"extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks~extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks"
11134481|NCT01781611|FG001|Participant Flow|Aspirin|"half a tablet of a 81mg aspirin twice daily for 24 weeks~81mg aspirin: half a tablet twice daily for 24 weeks"
11134482|NCT01781611|OG000|Outcome|Extended Release Dipyridamole/Aspirin|"extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks~extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks"
11134483|NCT01781611|OG001|Outcome|Aspirin|"half a tablet of a 81mg aspirin twice daily for 24 weeks~81mg aspirin: half a tablet twice daily for 24 weeks"
11134484|NCT01781611|EG000|Reported Event|Extended Release Dipyridamole/Aspirin|"extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks~extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks"
11134485|NCT01781611|EG001|Reported Event|Aspirin|"half a tablet of a 81mg aspirin twice daily for 24 weeks~81mg aspirin: half a tablet twice daily for 24 weeks"
11134486|NCT01781806|BG000|Baseline|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
11134487|NCT01781806|BG001|Baseline|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
11134488|NCT01781806|BG002|Baseline|Total|Total of all reporting groups
11134489|NCT01781806|FG000|Participant Flow|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
11134490|NCT01781806|FG001|Participant Flow|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
11134491|NCT01781806|OG000|Outcome|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
11134492|NCT01781806|OG001|Outcome|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
11134493|NCT01781806|OG000|Outcome|Cohort H (PrEP) and Cohort LM (PEP)|Participants enrolled in Cohort H (PrEP) and Cohort LM (PEP)
11134494|NCT01781806|EG000|Reported Event|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
11134495|NCT01781806|EG001|Reported Event|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
11134496|NCT01781832|BG000|Baseline|(ARFI)-Derived Shear Wave Velocities|"This is an new ultrasound-based technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. ARFI can be used to aid in detecting wall thickness and fibrosis in the urinary bladder of pediatric patients.~ARFI-Derived Shear Wave Velocities: This technology uses ultrasound scanning with acoustic radiation force impulse-derived (called ARFI). This technique measures shear wave velocities to obtain and analyze images of the urinary bladder. The research ultrasound scan takes 10-15 minutes to complete."
11134497|NCT01781832|FG000|Participant Flow|Subjects Having Urinary Testing|"Subjects were pediatric patients scheduled to have a test on their bladder called CMG (cystometrogram). CMG is an invasive test that requires insertion of a catheter (tube) into the bladder.~The patients agreed to have a research ultrasound (US) of their bladder. The US included a technique called elastography, which uses sound waves to measure the stiffness of tissue."
11134498|NCT01781832|OG000|Outcome|(ARFI)-Derived Shear Wave Velocities|"This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. This will aid in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients.~ARFI-Derived Shear Wave Velocities: An ultrasound scan using acoustic radiation force impulse-derived shear wave velocities to obtain images of the urinary bladder. The research ultrasound scan l takes 15 minutes to complete. The shear wave velocity is a measure of the stiffness of the bladder wall."
11134499|NCT01781832|EG000|Reported Event|(ARFI)-Derived Shear Wave Velocities|"This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. This will aid in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients.~ARFI-Derived Shear Wave Velocities: An ultrasound based scan using acoustic radiation force impulse-derived shear wave velocities to obtain images of the urinary bladder. The research ultrasound scan will take approximately 10 to 15 minutes to complete."
11134500|NCT01781962|BG000|Baseline|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
11134501|NCT01781962|FG000|Participant Flow|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
11134502|NCT01781962|OG000|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
11134503|NCT01781962|EG000|Reported Event|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
11134504|NCT01781975|BG000|Baseline|Imatinib Mesylate|"400 mg imatinib given once daily basis.~Imatinib Mesylate"
11134505|NCT01781975|BG001|Baseline|Placebo|"Placebo given once daily basis.~Placebo (For imatinib mesylate)"
11134506|NCT01781975|BG002|Baseline|Total|Total of all reporting groups
11134507|NCT01781975|FG000|Participant Flow|Imatinib Mesylate|"400 mg imatinib given once daily basis.~Imatinib Mesylate"
11134508|NCT01781975|FG001|Participant Flow|Placebo|"Placebo given once daily basis.~Placebo (For imatinib mesylate)"
11134509|NCT01781975|OG000|Outcome|Imatinib Mesylate|"400 mg imatinib given once daily basis.~Imatinib Mesylate"
11134510|NCT01781975|OG001|Outcome|Placebo|"Placebo given once daily basis.~Placebo (For imatinib mesylate)"
11134511|NCT01781975|EG000|Reported Event|Imatinib Mesylate|"400 mg imatinib given once daily basis.~Imatinib Mesylate"
11134512|NCT01781975|EG001|Reported Event|Placebo|"Placebo given once daily basis.~Placebo (For imatinib mesylate)"
11134513|NCT01782131|BG000|Baseline|Posaconazole|Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
11134514|NCT01782131|BG001|Baseline|Voriconazole|Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
11134515|NCT01782131|BG002|Baseline|Total|Total of all reporting groups
11134516|NCT01782131|FG000|Participant Flow|Posaconazole|Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
11134517|NCT01782131|FG001|Participant Flow|Voriconazole|Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
11134518|NCT01782131|OG000|Outcome|Posaconazole|Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
11134519|NCT01782131|OG001|Outcome|Voriconazole|Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
11134520|NCT01782131|EG000|Reported Event|Posaconazole|Participants received 300 mg posaconazole (POS) intravenous (IV) twice per day (BID) on Day 1, and then received 300 mg POS IV plus placebo IV once per day (QD) starting on Day 2 until clinically stable when participants transitioned to oral POS tablets plus oral placebo tablets QD for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
11134521|NCT01782131|EG001|Reported Event|Voriconazole|Participants received 6 mg/kg voriconazole (VOR) IV twice per day (BID) on Day 1, and then received 4 mg/kg VOR IV BID on Day 2 until clinically stable when participants transitioned to oral therapy with VOR capsules or VOR placebo capsules BID for up to 12 weeks of treatment. Most participants were expected to initiate treatment with IV therapy and transition to oral therapy as clinically indicated, with some participants initiating treatment with oral therapy, per clinical judgment.
11134522|NCT01782209|BG000|Baseline|Renal Transplant Patients|Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
11134523|NCT01782209|FG000|Participant Flow|Renal Transplant Patients|Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
11134524|NCT01782209|OG000|Outcome|Renal Transplant Patients|Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
11134525|NCT01782209|EG000|Reported Event|Renal Transplant Patients|Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
11134526|NCT01782222|BG000|Baseline|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
11134527|NCT01782222|BG001|Baseline|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
11134528|NCT01782222|BG002|Baseline|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
11134529|NCT01782222|BG003|Baseline|Total|Total of all reporting groups
11134530|NCT01782222|FG000|Participant Flow|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
11134531|NCT01782222|FG001|Participant Flow|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
11134532|NCT01782222|FG002|Participant Flow|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
11134533|NCT01782222|OG000|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
11134534|NCT01782222|OG001|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
11134535|NCT01782222|OG002|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
11134536|NCT01782222|EG000|Reported Event|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
11134537|NCT01782222|EG001|Reported Event|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~Optimal dosage:~The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
11134538|NCT01782222|EG002|Reported Event|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~Optimal dosage:~The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
11134539|NCT01782313|BG000|Baseline|Treatment (Tivozanib)|"Patients receive tivozanib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tivozanib: Given PO~laboratory biomarker analysis: Correlative studies"
11134540|NCT01782313|FG000|Participant Flow|Treatment (Tivozanib)|"Patients receive tivozanib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tivozanib: Given PO~laboratory biomarker analysis: Correlative studies"
11134541|NCT01782313|OG000|Outcome|Treatment (Tivozanib)|"Patients receive tivozanib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tivozanib: Given PO~laboratory biomarker analysis: Correlative studies"
11134542|NCT01782313|EG000|Reported Event|Treatment (Tivozanib)|"Patients receive tivozanib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tivozanib: Given PO~laboratory biomarker analysis: Correlative studies"
11134543|NCT01782326|BG000|Baseline|QVA149|QVA149 (110/50 μg) once daily
11134544|NCT01782326|BG001|Baseline|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
11134545|NCT01782326|BG002|Baseline|Total|Total of all reporting groups
11134546|NCT01782326|FG000|Participant Flow|QVA149|QVA149 (110/50 μg) once daily
11134547|NCT01782326|FG001|Participant Flow|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
11134548|NCT01782326|OG000|Outcome|QVA149|QVA149 (110/50 μg) once daily
11134549|NCT01782326|OG001|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
11134550|NCT01782326|EG000|Reported Event|QVA149|QVA149 (110/50 μg) once daily
11134551|NCT01782326|EG001|Reported Event|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
11134552|NCT01782378|BG000|Baseline|Real LED Treatment Series|Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
11134553|NCT01782378|BG001|Baseline|Sham LED Treatment Series|Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
11134554|NCT01782378|BG002|Baseline|Total|Total of all reporting groups
11134555|NCT01782378|FG000|Participant Flow|Real LED Treatment Series|Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial, near-infrared (NIR), 830nm LED Helmet and two light-emitting diode (LED) intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
11134556|NCT01782378|FG001|Participant Flow|Sham LED Treatment Series|Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
11134557|NCT01782378|OG000|Outcome|Real LED Treatment Series|Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
11134558|NCT01782378|OG001|Outcome|Sham LED Treatment Series|Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
11134559|NCT01782378|EG000|Reported Event|Real LED Treatment Series|Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
11134560|NCT01782378|EG001|Reported Event|Sham LED Treatment Series|Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
11134561|NCT01782469|BG000|Baseline|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
11134562|NCT01782469|FG000|Participant Flow|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
11134563|NCT01782469|OG000|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
11134564|NCT01782469|EG000|Reported Event|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
11134565|NCT01782482|BG000|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11134566|NCT01782482|BG001|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
10849788|NCT00298233|EG001|Reported Event|Standard Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
11134567|NCT01782482|BG002|Baseline|Total|Total of all reporting groups
11134568|NCT01782482|FG000|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11134569|NCT01782482|FG001|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11134570|NCT01782482|OG000|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11134571|NCT01782482|OG001|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11134572|NCT01782482|EG000|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11134573|NCT01782482|EG001|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
11134574|NCT01782495|BG000|Baseline|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134575|NCT01782495|BG001|Baseline|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134576|NCT01782495|BG002|Baseline|Arm C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
11134577|NCT01782495|BG003|Baseline|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134578|NCT01782495|BG004|Baseline|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134579|NCT01782495|BG005|Baseline|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134580|NCT01782495|BG006|Baseline|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
11134581|NCT01782495|BG007|Baseline|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134582|NCT01782495|BG008|Baseline|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
11134583|NCT01782495|BG009|Baseline|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134584|NCT01782495|BG010|Baseline|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134585|NCT01782495|BG011|Baseline|Total|Total of all reporting groups
11134586|NCT01782495|FG000|Participant Flow|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134587|NCT01782495|FG001|Participant Flow|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134588|NCT01782495|FG002|Participant Flow|Arm C|Liver transplant receipts with HCV 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
11134589|NCT01782495|FG003|Participant Flow|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134590|NCT01782495|FG004|Participant Flow|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134591|NCT01782495|FG005|Participant Flow|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
10887360|NCT00500149|FG001|Participant Flow|Placebo First|Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention
11134592|NCT01782495|FG006|Participant Flow|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
11134593|NCT01782495|FG007|Participant Flow|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134594|NCT01782495|FG008|Participant Flow|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
11134595|NCT01782495|FG009|Participant Flow|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134596|NCT01782495|FG010|Participant Flow|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134597|NCT01782495|OG000|Outcome|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
10887361|NCT00500149|OG000|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
10887362|NCT00500149|OG001|Outcome|Placebo|Matching placebo
11134598|NCT01782495|OG001|Outcome|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134599|NCT01782495|OG002|Outcome|Arm C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
11134600|NCT01782495|OG003|Outcome|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134601|NCT01782495|OG004|Outcome|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134602|NCT01782495|OG005|Outcome|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134603|NCT01782495|OG006|Outcome|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
11134604|NCT01782495|OG007|Outcome|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134605|NCT01782495|OG008|Outcome|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
11134606|NCT01782495|OG009|Outcome|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134607|NCT01782495|OG010|Outcome|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134608|NCT01782495|EG000|Reported Event|ARM A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134609|NCT01782495|EG001|Reported Event|ARM B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134610|NCT01782495|EG002|Reported Event|ARM C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
11134611|NCT01782495|EG003|Reported Event|ARM D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134612|NCT01782495|EG004|Reported Event|ARM E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134613|NCT01782495|EG005|Reported Event|ARM F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134614|NCT01782495|EG006|Reported Event|ARM G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
10887363|NCT00500149|EG000|Reported Event|Vyvanse|
10887364|NCT00500149|EG001|Reported Event|Placebo|
11134615|NCT01782495|EG007|Reported Event|ARM H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134616|NCT01782495|EG008|Reported Event|ARM I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
11134617|NCT01782495|EG009|Reported Event|ARM J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11134618|NCT01782495|EG010|Reported Event|ARM K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
11134619|NCT01782664|BG000|Baseline|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
11134620|NCT01782664|BG001|Baseline|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134621|NCT01782664|BG002|Baseline|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134622|NCT01782664|BG003|Baseline|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134623|NCT01782664|BG004|Baseline|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134624|NCT01782664|BG005|Baseline|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134625|NCT01782664|BG006|Baseline|Total|Total of all reporting groups
11134626|NCT01782664|FG000|Participant Flow|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
11134627|NCT01782664|FG001|Participant Flow|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134628|NCT01782664|FG002|Participant Flow|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134629|NCT01782664|FG003|Participant Flow|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134630|NCT01782664|FG004|Participant Flow|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134631|NCT01782664|FG005|Participant Flow|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134632|NCT01782664|OG000|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
11134633|NCT01782664|OG001|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134634|NCT01782664|OG002|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134635|NCT01782664|OG003|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134636|NCT01782664|OG004|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134637|NCT01782664|OG005|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134638|NCT01782664|EG000|Reported Event|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
11134639|NCT01782664|EG001|Reported Event|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134640|NCT01782664|EG002|Reported Event|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134641|NCT01782664|EG003|Reported Event|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134642|NCT01782664|EG004|Reported Event|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134643|NCT01782664|EG005|Reported Event|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
11134644|NCT01782690|BG000|Baseline|Erlotinib Plus Gemcitabine|Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
11134645|NCT01782690|FG000|Participant Flow|Erlotinib Plus Gemcitabine|Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
11134646|NCT01782690|OG000|Outcome|Erlotinib Plus Gemcitabine|Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
11134647|NCT01782690|EG000|Reported Event|Erlotinib Plus Gemcitabine|Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
11134648|NCT01782742|BG000|Baseline|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
11134649|NCT01782742|BG001|Baseline|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
11134650|NCT01782742|BG002|Baseline|Total|Total of all reporting groups
11134651|NCT01782742|FG000|Participant Flow|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
11134652|NCT01782742|FG001|Participant Flow|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
11134653|NCT01782742|OG000|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
11134654|NCT01782742|OG001|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
11134655|NCT01782742|OG000|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
11134656|NCT01782742|OG001|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
11134657|NCT01782742|EG000|Reported Event|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
11134658|NCT01782742|EG001|Reported Event|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
11134659|NCT01782833|BG000|Baseline|Pletaal® SR Capsule|Subjects who received at least 1 dose of Pletaal® SR Capsule during the study period and had follow-up for safety assessment.
11134660|NCT01782833|FG000|Participant Flow|Pletaal® SR Capsule|Patients who were receiving or planned to receive Pletaal® SR Capsule according to investigator's medical judgement after a written contract with the study site and provided a written consent to use personal information.
11134661|NCT01782833|OG000|Outcome|Pletaal® SR Capsule|Patients who were receiving or planned to receive Pletaal® SR Capsule according to investigator's medical judgement after a written contract with the study site and provided a written consent to use personal information.
11134662|NCT01782833|EG000|Reported Event|Pletaal® SR Capsule|Subjects who received at least 1 dose of Pletaal® SR Capsule during the study period and had follow-up for safety assessment.
11134663|NCT01782859|BG000|Baseline|Placebo|"Control group~Placebo (for Prednisone)"
11134664|NCT01782859|BG001|Baseline|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
11134665|NCT01782859|BG002|Baseline|Total|Total of all reporting groups
11134666|NCT01782859|FG000|Participant Flow|Placebo|"Control group~Placebo (for Prednisone)"
11134667|NCT01782859|FG001|Participant Flow|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
11134668|NCT01782859|OG000|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
11134669|NCT01782859|OG001|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
11134670|NCT01782859|OG001|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV~Prednisone~Hydrocortisone"
11134671|NCT01782859|EG000|Reported Event|Placebo|"Control group~Placebo (for Prednisone)"
11134672|NCT01782859|EG001|Reported Event|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
11134673|NCT01782872|BG000|Baseline|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
11134674|NCT01782872|BG001|Baseline|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
11134675|NCT01782872|BG002|Baseline|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
11134676|NCT01782872|BG003|Baseline|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
11134677|NCT01782872|BG004|Baseline|Total|Total of all reporting groups
11134678|NCT01782872|FG000|Participant Flow|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
11134679|NCT01782872|FG001|Participant Flow|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
11134680|NCT01782872|FG002|Participant Flow|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
11134681|NCT01782872|FG003|Participant Flow|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
11134682|NCT01782872|OG000|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
11134683|NCT01782872|OG001|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
11134684|NCT01782872|OG002|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
11134685|NCT01782872|OG003|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
11134686|NCT01782872|EG000|Reported Event|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
11134687|NCT01782872|EG001|Reported Event|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
11134688|NCT01782872|EG002|Reported Event|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
11134689|NCT01782872|EG003|Reported Event|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
11134690|NCT01782885|BG000|Baseline|Acetaminophen|Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) during 6 weeks.
11134691|NCT01782885|BG001|Baseline|Intra-articular Injection of PRP|Intra-articular injection of PRP: Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks treatment).
11134692|NCT01782885|BG002|Baseline|Total|Total of all reporting groups
11134693|NCT01782885|FG000|Participant Flow|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
11134694|NCT01782885|FG001|Participant Flow|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
11134695|NCT01782885|OG000|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
11134696|NCT01782885|OG001|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
11134697|NCT01782885|EG000|Reported Event|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
11134698|NCT01782885|EG001|Reported Event|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
11134699|NCT01782898|BG000|Baseline|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
11134700|NCT01782898|BG001|Baseline|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
11134701|NCT01782898|BG002|Baseline|Total|Total of all reporting groups
11134702|NCT01782898|FG000|Participant Flow|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
11134703|NCT01782898|FG001|Participant Flow|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
11134704|NCT01782898|OG000|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
11134705|NCT01782898|OG001|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
11134706|NCT01782898|EG000|Reported Event|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
11134707|NCT01782898|EG001|Reported Event|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
11134708|NCT01782963|BG000|Baseline|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
11134709|NCT01782963|FG000|Participant Flow|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
11134710|NCT01782963|OG000|Outcome|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
11134711|NCT01782963|OG000|Outcome|High Risk Cytogenetics|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
11134712|NCT01782963|OG001|Outcome|Low Risk Cytogenetics|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
11134713|NCT01782963|OG000|Outcome|Intravenous|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
11134714|NCT01782963|OG001|Outcome|Subcutaneous|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide"
11134715|NCT01782963|EG000|Reported Event|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
11134716|NCT01783054|BG000|Baseline|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
11134717|NCT01783054|FG000|Participant Flow|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
11134718|NCT01783054|OG000|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
11134719|NCT01783054|EG000|Reported Event|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
11134720|NCT01783080|BG000|Baseline|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
11134721|NCT01783080|FG000|Participant Flow|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
11134722|NCT01783080|OG000|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
11134723|NCT01783080|EG000|Reported Event|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
11134724|NCT01783236|BG000|Baseline|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
11134725|NCT01783236|BG001|Baseline|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
11134726|NCT01783236|BG002|Baseline|Total|Total of all reporting groups
11134727|NCT01783236|FG000|Participant Flow|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
10887365|NCT00500240|BG000|Baseline|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
11134728|NCT01783236|FG001|Participant Flow|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
11134729|NCT01783236|OG000|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
11134730|NCT01783236|OG001|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
11134731|NCT01783236|EG000|Reported Event|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
11134732|NCT01783236|EG001|Reported Event|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
11134733|NCT01783418|BG000|Baseline|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
11134734|NCT01783418|BG001|Baseline|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
11134735|NCT01783418|BG002|Baseline|Total|Total of all reporting groups
11134736|NCT01783418|FG000|Participant Flow|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
11134737|NCT01783418|FG001|Participant Flow|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
11134738|NCT01783418|OG000|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
11134739|NCT01783418|OG001|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
11134740|NCT01783418|EG000|Reported Event|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
11134741|NCT01783418|EG001|Reported Event|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
11134742|NCT01783444|BG000|Baseline|Everolimus 10 mg + Exemestane 25 mg|Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).
11134743|NCT01783444|BG001|Baseline|Everolimus 10 mg|Everolimus (10 mg daily) (investigational arm).
11134744|NCT01783444|BG002|Baseline|Capecitabine 1250 mg/m2|Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
11134745|NCT01783444|BG003|Baseline|Total|Total of all reporting groups
11134746|NCT01783444|FG000|Participant Flow|Everolimus 10 mg + Exemestane 25 mg|Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).
11134747|NCT01783444|FG001|Participant Flow|Everolimus 10 mg|Everolimus (10 mg daily) (investigational arm).
11134748|NCT01783444|FG002|Participant Flow|Capecitabine 1250 mg/m2|Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
11134749|NCT01783444|OG000|Outcome|Everolimus 10 mg + Exemestane 25 mg|Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).
11134750|NCT01783444|OG001|Outcome|Everolimus 10 mg|Everolimus (10 mg daily) (investigational arm).
11134751|NCT01783444|OG001|Outcome|Capecitabine 1250 mg/m2|Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
11134752|NCT01783444|OG002|Outcome|Capecitabine 1250 mg/m2|Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
11134753|NCT01783444|EG000|Reported Event|Everolimus 10 mg + Exemestane 25 mg|Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).
11134754|NCT01783444|EG001|Reported Event|Everolimus 10 mg|Everolimus (10 mg daily) (investigational arm).
11134755|NCT01783444|EG002|Reported Event|Capecitabine 1250 mg/m2|Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
11134756|NCT01783470|BG000|Baseline|All Participants|All participants randomized to placebo or drug first then received the other treatment second.
11134757|NCT01783470|FG000|Participant Flow|Placebo Then beta3-adrenergic Receptor (AR) Agonist|Participants administered a lactose-based oral placebo followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received drug.
11134758|NCT01783470|FG001|Participant Flow|beta3-adrenergic Receptor (AR) Agonist Then Placebo|Participants administered an oral beta3-AR agonist followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received placebo.
11134759|NCT01783470|OG000|Outcome|Placebo|"lactose~Placebo"
11134760|NCT01783470|OG001|Outcome|beta3-adrenergic Receptor (AR)|
11134761|NCT01783470|EG000|Reported Event|Placebo|"lactose~Placebo"
11134762|NCT01783470|EG001|Reported Event|beta3-adrenergic Receptor Agonist|"single dose~beta3-adrenergic receptor agonist: single dose"
11134763|NCT01783470|EG002|Reported Event|Mild Cold Exposure|2 hours while wearing a cooling vest with water set to 14-16 C. This arm was before randomization and had 15 participants.
11134764|NCT01783483|BG000|Baseline|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
11149642|NCT01871805|EG004|Reported Event|Alectinib 900 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11149643|NCT01871805|EG005|Reported Event|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
11134765|NCT01783483|BG001|Baseline|SternaLock Blu Sternal Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
11134766|NCT01783483|BG002|Baseline|Total|Total of all reporting groups
11134767|NCT01783483|FG000|Participant Flow|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
11134768|NCT01783483|FG001|Participant Flow|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
11134769|NCT01783483|OG000|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
11134770|NCT01783483|OG001|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
11134771|NCT01783483|EG000|Reported Event|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
11134772|NCT01783483|EG001|Reported Event|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
11134773|NCT01783496|BG000|Baseline|Framed Tip|Treatment with Thermage CPT Framed Tip
11134774|NCT01783496|BG001|Baseline|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
11134775|NCT01783496|BG002|Baseline|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
11134776|NCT01783496|BG003|Baseline|Total Tip|Treatment with the Thermage CPT Total tip
11134777|NCT01783496|BG004|Baseline|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
11134778|NCT01783496|BG005|Baseline|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
11134779|NCT01783496|BG006|Baseline|Total|Total of all reporting groups
11134780|NCT01783496|FG000|Participant Flow|Framed Tip|Treatment with Thermage CPT Framed Tip
11134781|NCT01783496|FG001|Participant Flow|Pattern Tip|Treatment with the Thermage CPT Pattern Tip Using Super-Pass Technique
11134782|NCT01783496|FG002|Participant Flow|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip Using Staggered-Pass Technique
11134783|NCT01783496|FG003|Participant Flow|Total Tip|Treatment with the Thermage CPT Total tip
11134784|NCT01783496|FG004|Participant Flow|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
11134785|NCT01783496|FG005|Participant Flow|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
11134786|NCT01783496|OG000|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
11134787|NCT01783496|OG001|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
11134788|NCT01783496|OG002|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
11134789|NCT01783496|OG003|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
11134790|NCT01783496|OG004|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
11134791|NCT01783496|OG005|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
11134792|NCT01783496|EG000|Reported Event|Framed Tip|"Treatment with Thermage CPT Framed Tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
11134793|NCT01783496|EG001|Reported Event|Pattern Tip|"Treatment with the Thermage CPT Pattern Tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
11134794|NCT01783496|EG002|Reported Event|Pattern Tip Group 2|"Treatment with the Thermage CPT Pattern tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
11134795|NCT01783496|EG003|Reported Event|Total Tip|"Treatment with the Thermage CPT Total tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
11134796|NCT01783496|EG004|Reported Event|Framed and Patterned Tip|"Split face treatment with the Thermage CPT Framed and Patterned tips~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
11134797|NCT01783496|EG005|Reported Event|Total and Patterned Tip|"Split face treatment with the Thermage CPT Total and Patterned tips~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
11134798|NCT01783522|BG000|Baseline|Arm I (Preventative Nutritional Supplementation)|"Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.~glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.~quality-of-life assessment: Ancillary studies"
11134799|NCT01783522|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.~quality-of-life assessment: Ancillary studies~placebo: Given PO"
11134800|NCT01783522|BG002|Baseline|Total|Total of all reporting groups
11134801|NCT01783522|FG000|Participant Flow|Arm I (Preventative Nutritional Supplementation)|"Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.~glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.~quality-of-life assessment: Ancillary studies"
11134802|NCT01783522|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.~quality-of-life assessment: Ancillary studies~placebo: Given PO"
11134803|NCT01783522|OG000|Outcome|Arm I (Preventative Nutritional Supplementation)|"Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.~glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.~quality-of-life assessment: Ancillary studies"
11134804|NCT01783522|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.~quality-of-life assessment: Ancillary studies~placebo: Given PO"
11134805|NCT01783522|EG000|Reported Event|Arm I (Preventative Nutritional Supplementation)|"Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.~glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.~quality-of-life assessment: Ancillary studies"
11134806|NCT01783522|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.~quality-of-life assessment: Ancillary studies~placebo: Given PO"
11134807|NCT01783548|BG000|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
11134808|NCT01783548|BG001|Baseline|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
11134809|NCT01783548|BG002|Baseline|Total|Total of all reporting groups
11134810|NCT01783548|FG000|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
11134811|NCT01783548|FG001|Participant Flow|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
11134812|NCT01783548|OG000|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
11134813|NCT01783548|OG001|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
11134814|NCT01783548|EG000|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
11134815|NCT01783548|EG001|Reported Event|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
11134816|NCT01783561|BG000|Baseline|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
11134817|NCT01783561|BG001|Baseline|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
11134818|NCT01783561|BG002|Baseline|Total|Total of all reporting groups
11226861|NCT02378714|BG000|Baseline|Standard Treatment + Placebo Varenicline|"Standard behavioral smoking cessation treatment plus placebo varenicline~Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11134819|NCT01783561|FG000|Participant Flow|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
11134820|NCT01783561|FG001|Participant Flow|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
11134821|NCT01783561|OG000|Outcome|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
11134822|NCT01783561|OG001|Outcome|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
11134823|NCT01783561|EG000|Reported Event|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
11134824|NCT01783561|EG001|Reported Event|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
11134825|NCT01783574|BG000|Baseline|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
11134826|NCT01783574|BG001|Baseline|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
11134827|NCT01783574|BG002|Baseline|Total|Total of all reporting groups
11134828|NCT01783574|FG000|Participant Flow|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
11134829|NCT01783574|FG001|Participant Flow|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
11134830|NCT01783574|OG000|Outcome|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
11134831|NCT01783574|OG001|Outcome|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
11134832|NCT01783574|EG000|Reported Event|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
11134833|NCT01783574|EG001|Reported Event|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
11134834|NCT01783639|BG000|Baseline|Arm 1|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
11134835|NCT01783639|FG000|Participant Flow|WIRION|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
11134836|NCT01783639|OG000|Outcome|Arm 1|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
11134837|NCT01783639|EG000|Reported Event|WIRION|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
11134838|NCT01783678|BG000|Baseline|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
11134839|NCT01783678|BG001|Baseline|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
11134840|NCT01783678|BG002|Baseline|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
11134841|NCT01783678|BG003|Baseline|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
11134842|NCT01783678|BG004|Baseline|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
11134843|NCT01783678|BG005|Baseline|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
11134844|NCT01783678|BG006|Baseline|Total|Total of all reporting groups
11134845|NCT01783678|FG000|Participant Flow|Genotype 2 Treatment-naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
11134846|NCT01783678|FG001|Participant Flow|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
11134847|NCT01783678|FG002|Participant Flow|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
11134848|NCT01783678|FG003|Participant Flow|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
11134849|NCT01783678|FG004|Participant Flow|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
11134850|NCT01783678|FG005|Participant Flow|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
11134851|NCT01783678|OG000|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
11134852|NCT01783678|OG001|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
11134853|NCT01783678|OG002|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
11134854|NCT01783678|OG003|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
11134855|NCT01783678|OG004|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
11134856|NCT01783678|OG005|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
11134857|NCT01783678|OG006|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
11134858|NCT01783678|OG007|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
11134859|NCT01783678|OG001|Outcome|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
11134860|NCT01783678|OG002|Outcome|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
11134861|NCT01783678|EG000|Reported Event|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
11134862|NCT01783678|EG001|Reported Event|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
11134863|NCT01783678|EG002|Reported Event|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
11134864|NCT01783730|BG000|Baseline|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
11134865|NCT01783730|FG000|Participant Flow|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
11134866|NCT01783730|OG000|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
11134867|NCT01783730|EG000|Reported Event|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
11134868|NCT01783743|BG000|Baseline|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
11134869|NCT01783743|BG001|Baseline|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
11134870|NCT01783743|BG002|Baseline|Total|Total of all reporting groups
11134871|NCT01783743|FG000|Participant Flow|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
11134872|NCT01783743|FG001|Participant Flow|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
11134873|NCT01783743|OG000|Outcome|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
11134874|NCT01783743|OG001|Outcome|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
11134875|NCT01783743|EG000|Reported Event|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
11134876|NCT01783743|EG001|Reported Event|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
11134877|NCT01783821|BG000|Baseline|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
11134878|NCT01783821|BG001|Baseline|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
11134879|NCT01783821|BG002|Baseline|Total|Total of all reporting groups
11134880|NCT01783821|FG000|Participant Flow|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
11134881|NCT01783821|FG001|Participant Flow|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
11134882|NCT01783821|OG000|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
11134883|NCT01783821|OG001|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
11134884|NCT01783821|EG000|Reported Event|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
11134885|NCT01783821|EG001|Reported Event|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
11134886|NCT01783847|BG000|Baseline|Recombinant Human Erythropoietin (EPO)|"20,000 unit per day of EPO, Intravenous infusion for three sequential days.~Recombinant human erythropoietin (EPO): 4000 units per vial"
11134887|NCT01783847|BG001|Baseline|Methylprednisolone|1 gram per day intravenous injection of Methylprednisolone for 3 days.
11134888|NCT01783847|BG002|Baseline|Observation|No any treatment will be given
11134889|NCT01783847|BG003|Baseline|Total|Total of all reporting groups
11134890|NCT01783847|FG000|Participant Flow|Recombinant Human Erythropoietin (EPO)|"20,000 unit per day of EPO, Intravenous infusion for three sequential days.~Recombinant human erythropoietin (EPO): 4000 units per vial"
11134891|NCT01783847|FG001|Participant Flow|Methylprednisolone|250 mg intravenous injection of Methylprednisolone for 3 days.
11134892|NCT01783847|FG002|Participant Flow|Observation|No any treatment will be given
11134893|NCT01783847|OG000|Outcome|Recombinant Human Erythropoietin (EPO)|"Intravenous EPO 10,000 IU for 5-13 years of age and 20,000 IU for >13 years/ day for 3 days~Recombinant human erythropoietin (EPO): 4000 units per vial"
11134894|NCT01783847|OG001|Outcome|Methylprednisolone|"Just Intravenous Methyl prednisolone 250 mg every 6 hours for 3 days.~Methyl prednisolone: 250 mg every 6 hours for 3 days."
11134895|NCT01783847|OG002|Outcome|Observation|"Observation~Observation: Just observation"
11134896|NCT01783847|OG000|Outcome|Recombinant Human Erythropoietin (EPO)|"20,000 unit per day of EPO, Intravenous infusion for three sequential days.~Recombinant human erythropoietin (EPO): 4000 units per vial"
11134897|NCT01783847|OG001|Outcome|Methylprednisolone|250 mg intravenous injection of Methylprednisolone for 3 days.
11134898|NCT01783847|OG002|Outcome|Observation|No any treatment will be given
11134899|NCT01783847|EG000|Reported Event|Recombinant Human Erythropoietin (EPO)|"20,000 unit per day of EPO, Intravenous infusion for three sequential days.~Recombinant human erythropoietin (EPO): 4000 units per vial"
11134900|NCT01783847|EG001|Reported Event|Methylprednisolone|250 mg intravenous injection of Methylprednisolone for 3 days.
11134901|NCT01783847|EG002|Reported Event|Observation|No any treatment will be given
11134902|NCT01783860|BG000|Baseline|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
11134903|NCT01783860|BG001|Baseline|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
11134904|NCT01783860|BG002|Baseline|Total|Total of all reporting groups
11134905|NCT01783860|FG000|Participant Flow|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
11134906|NCT01783860|FG001|Participant Flow|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
11134907|NCT01783860|OG000|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
11134908|NCT01783860|OG001|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
11134909|NCT01783860|EG000|Reported Event|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
11134910|NCT01783860|EG001|Reported Event|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
11134911|NCT01783886|BG000|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) 2Q4 over 48 weeks.
11134912|NCT01783886|BG001|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
11134913|NCT01783886|BG002|Baseline|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
11134914|NCT01783886|BG003|Baseline|Total|Total of all reporting groups
11134915|NCT01783886|FG000|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
11134916|NCT01783886|FG001|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
11134917|NCT01783886|FG002|Participant Flow|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
11134918|NCT01783886|OG000|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
11134919|NCT01783886|OG001|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
11134920|NCT01783886|OG002|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
11134921|NCT01783886|EG000|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
11134922|NCT01783886|EG001|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
11134923|NCT01783886|EG002|Reported Event|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
11134924|NCT01783912|BG000|Baseline|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
11134925|NCT01783912|BG001|Baseline|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
11342022|NCT03695094|FG001|Participant Flow|Group 2 (Neutral [Control])|Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
11134926|NCT01783912|BG002|Baseline|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
11134927|NCT01783912|BG003|Baseline|Total|Total of all reporting groups
11134928|NCT01783912|FG000|Participant Flow|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
11134929|NCT01783912|FG001|Participant Flow|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
11134930|NCT01783912|FG002|Participant Flow|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
11134931|NCT01783912|OG000|Outcome|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
11134932|NCT01783912|OG001|Outcome|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
11134933|NCT01783912|OG002|Outcome|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
11134934|NCT01783912|EG000|Reported Event|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
10879682|NCT00459316|FG000|Participant Flow|Group 1: CD4%≥15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening ≥15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible/randomized receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
11134935|NCT01783912|EG001|Reported Event|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
11134936|NCT01783912|EG002|Reported Event|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
11134937|NCT01783938|BG000|Baseline|Nivolumab Followed by Ipilimumab|Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
11134938|NCT01783938|BG001|Baseline|Ipilimumab Followed by Nivolumab|Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
11134939|NCT01783938|BG002|Baseline|Total|Total of all reporting groups
11134940|NCT01783938|FG000|Participant Flow|Nivolumab Followed by Ipilimumab|Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
11134941|NCT01783938|FG001|Participant Flow|Ipilimumab Followed by Nivolumab|Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
11134942|NCT01783938|OG000|Outcome|Nivolumab Followed by Ipilimumab|Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
11134943|NCT01783938|OG001|Outcome|Ipilimumab Followed by Nivolumab|Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
11134944|NCT01783938|EG000|Reported Event|Nivolumab Followed by Ipilimumab|Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
11134945|NCT01783938|EG001|Reported Event|Ipilimumab Followed by Nivolumab|Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
11134946|NCT01783990|BG000|Baseline|Active|"Blood and urine specimens, and questionnaires related to the child's health status.~Liver Spleen Scan~Abdominal Ultrasound~Brain magnetic resonance imaging (MRI) / magnetic resonance angiography (MRA)~Cardiac Echocardiogram/Pulmonary Function Testing~Transcranial Doppler~Neuropsychology Testing (Vineland, Wechsler Intelligence Scale for Children (WISC-IV), Connor Continuous Performance Test 2nd Edition (CPT II) and Pediatric Quality of Life Inventory(PedsQOL))~Patients could be on or off hydroxyurea at the start of Follow-Up Study II, and could change treatment during the study."
11134947|NCT01783990|BG001|Baseline|Passive|"Information from usual clinical care of sickle cell disease. We will collect information from routine tests ordered by the child's clinical sickle cell doctors.~Patients could be on or off hydroxyurea at the start of Follow-Up Study II, and could change treatment during the study."
11134948|NCT01783990|BG002|Baseline|Total|Total of all reporting groups
11134949|NCT01783990|FG000|Participant Flow|Active|Complete blood counts (CBCs), reticulocytes, differential, lactate dehydrogenase (LDH), bilirubin and alanine transaminases (ALTs), cystatin C, blood urea nitrogen (BUN), Creatinine, fetal hemoglobin (HbF), pit counts, Howell Jolly Body (HJB), and urine microalbumin:creatinine ratio were collected at study entry, annually, and exit to Follow-Up Study II. Variable-diversity-joining (VDJ) and a stored blood sample were collected at study entry and study exit. Additional tests that include liver/spleen scan, abdominal sonogram, pulmonary function testing, magnetic resonance imaging (MRI) / magnetic resonance angiography (MRA), cardiac echocardiogram, or neuropsychology testing were collected once during the study when the child was 10 years old.
11134950|NCT01783990|FG001|Participant Flow|Passive|Complete blood counts (CBCs), reticulocytes, differential, lactate dehydrogenase (LDH), bilirubin and alanine transaminases (ALTs), cystatin C, blood urea nitrogen (BUN), Creatinine, fetal hemoglobin (HbF), pit counts, Howell Jolly Body (HJB), variable-diversity-joining (VDJ), urine microalbumin:creatinine ratio and a stored blood sample were collected at study entry and exit to Follow-Up Study II. Additional tests that include liver/spleen scan, abdominal sonogram, pulmonary function testing, MRI/MRA, cardiac echocardiogram, or neuropsychology testing were collected as part of clinical care.
11134951|NCT01783990|OG000|Outcome|Randomized to Hydroxyurea|Subjects randomized to Hydroxyurea in the randomized phase III clinical trial.
11134952|NCT01783990|OG001|Outcome|Randomized to Placebo|Subjects randomized to Placebo in the randomized phase III clinical trial.
11134953|NCT01783990|OG000|Outcome|On Hydroxyurea at the Time of Visit|Subjects who were on hydroxyurea at the time of study visit
11134954|NCT01783990|OG001|Outcome|Off Hydroxyurea at the Time of Visit|Subjects who were off hydroxyurea at the time of study visit
11134955|NCT01783990|EG000|Reported Event|Randomized to Hydroxyurea|"Subjects randomized to Hydroxyurea in the randomized phase III clinical trial.~150 subjects (130 in active and 20 in passive follow-up group) consented to follow-up II study. Of the 150 subjects, 77 subjects were randomized to the hydroxyurea treatment group during the randomized phase III clinical trial."
10887366|NCT00500240|BG001|Baseline|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
11008800|NCT01098422|BG000|Baseline|Yttrium-90 Radioactive Resin Microspheres|"Yttrium-90 Radioactive Resin Microspheres~Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity."
11008801|NCT01098422|FG000|Participant Flow|Yttrium-90 Radioactive Resin Microspheres|"Yttrium-90 Radioactive Resin Microspheres~Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity."
11008802|NCT01098422|OG000|Outcome|Yttrium-90 Radioactive Resin Microspheres|"Yttrium-90 Radioactive Resin Microspheres~Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity."
11008803|NCT01098422|EG000|Reported Event|Yttrium-90 Radioactive Resin Microspheres|"Yttrium-90 Radioactive Resin Microspheres~Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity."
11008804|NCT01098461|BG000|Baseline|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008805|NCT01098461|BG001|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008806|NCT01098461|BG002|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008807|NCT01098461|BG003|Baseline|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008808|NCT01098461|BG004|Baseline|Total|Total of all reporting groups
11008809|NCT01098461|FG000|Participant Flow|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008810|NCT01098461|FG001|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008811|NCT01098461|FG002|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008812|NCT01098461|FG003|Participant Flow|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11134956|NCT01783990|EG001|Reported Event|Randomized to Placebo|"Subjects randomized to Placebo in the randomized phase III clinical trial.~150 subjects (130 in active and 20 in passive follow-up group) consented to follow-up II study. Of the 150 subjects, 73 subjects were randomized to the placebo treatment group during the randomized phase III clinical trial."
10887367|NCT00500240|BG002|Baseline|Total|Total of all reporting groups
10887368|NCT00500240|FG000|Participant Flow|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
11008813|NCT01098461|OG000|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008814|NCT01098461|OG001|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008815|NCT01098461|OG002|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008816|NCT01098461|OG003|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008817|NCT01098461|OG000|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008818|NCT01098461|EG000|Reported Event|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008819|NCT01098461|EG001|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11134957|NCT01784029|BG000|Baseline|Low Dose|"VItamin D3 1,000 IU~1 x day, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134958|NCT01784029|BG001|Baseline|Weekly High Dose|"Vitamin D3 50,000 IU~1x week, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134959|NCT01784029|BG002|Baseline|Daily High Dose|"Vitamin D3 5,000 IU~1x day, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134960|NCT01784029|BG003|Baseline|Total|Total of all reporting groups
11134961|NCT01784029|FG000|Participant Flow|Low Dose|"VItamin D3 1,000 IU~1 x day, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134962|NCT01784029|FG001|Participant Flow|Weekly High Dose|"Vitamin D3 50,000 IU~1x week, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134963|NCT01784029|FG002|Participant Flow|Daily High Dose|"Vitamin D3 5,000 IU~1x day, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134964|NCT01784029|OG000|Outcome|Low Dose|"VItamin D3 1,000 IU~1 x day, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134965|NCT01784029|OG001|Outcome|Weekly High Dose|"Vitamin D3 50,000 IU~1x week, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134966|NCT01784029|OG002|Outcome|Daily High Dose|"Vitamin D3 5,000 IU~1x day, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134967|NCT01784029|EG000|Reported Event|Low Dose|"VItamin D3 1,000 IU~1 x day, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134968|NCT01784029|EG001|Reported Event|Weekly High Dose|"Vitamin D3 50,000 IU~1x week, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134969|NCT01784029|EG002|Reported Event|Daily High Dose|"Vitamin D3 5,000 IU~1x day, 8 weeks~Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up."
11134970|NCT01784055|BG000|Baseline|Overall|All subjects
11134971|NCT01784055|FG000|Participant Flow|Overall|All Subjects
10887284|NCT00499616|OG001|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11134972|NCT01784055|OG000|Outcome|Overall|All patients
11134973|NCT01784055|EG000|Reported Event|Overall|All patients
11134974|NCT01784068|BG000|Baseline|NTCS Phase|Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID)
11134975|NCT01784068|FG000|Participant Flow|NTCS Phase|Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID)
11134976|NCT01784068|FG001|Participant Flow|TFR Phase|Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given
11134977|NCT01784068|OG000|Outcome|TFR Phase|Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given
11134978|NCT01784068|EG000|Reported Event|NTCS Phase|Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID)
11134979|NCT01784068|EG001|Reported Event|TFR Phase|Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given
11134980|NCT01784068|EG002|Reported Event|NTRI Phase|If at any time during TFR phase the patient lost MMR, nilotinib treatment was to be immediately re-initiated (nilotinib 300 mg BID)
11134981|NCT01784068|EG003|Reported Event|NTCT Phase|Patients with no MRD at the end of consolidation phase entered the continuation phase of the study and continue with nilotinib 300 mg BID
11134982|NCT01784068|EG004|Reported Event|TFR-2 Phase|Patients with MRD at the end of the continuation phase entered the TFR-2 phase of the study where no treatment was given
11134983|NCT01784068|EG005|Reported Event|NTRI-2 Phase|If at any time during TFR phase or TFR-2 phase the patient lost MMR, nilotinib treatment was to be immediately re-initiated (nilotinib 300 mg BID)
11134984|NCT01784068|EG006|Reported Event|NTCT-P Phase|Patients with no MRD at the end of continuation phase entered the prolonged continuation phase of the study
11134985|NCT01784068|EG007|Reported Event|All Patients|All patients enrolled in the study
11134986|NCT01784211|BG000|Baseline|LY2605541 (Part A)|0.5 units per kilogram (U/kg) LY2605541 subcutaneously (SC) once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
11134987|NCT01784211|BG001|Baseline|Glargine (Part A)|0.5 U/kg insulin Glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
11134988|NCT01784211|BG002|Baseline|Total|Total of all reporting groups
11134989|NCT01784211|FG000|Participant Flow|LY2605541 (Part A)|0.5 units per kilogram (U/kg) LY2605541 subcutaneously (SC) once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
11134990|NCT01784211|FG001|Participant Flow|Glargine (Part A)|0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
11134991|NCT01784211|FG002|Participant Flow|First LY2605541 + Exercise, Then LY2605541 Alone (Part B)|0.5 U/kg LY2605541 SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 17 (no exercise on Day 20).
11134992|NCT01784211|FG003|Participant Flow|First LY2605541 Alone, Then LY2605541 + Exercise (Part B)|0.5 U/kg LY2605541 SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 20 (no exercise on Day 17).
10887369|NCT00500240|FG001|Participant Flow|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
11008820|NCT01098461|EG002|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008821|NCT01098461|EG003|Reported Event|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
11008822|NCT01098474|BG000|Baseline|SB692342 2 Dose Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, on a 0, 1 month schedule after having completed their primary EPI regimen.
11008823|NCT01098474|BG001|Baseline|SB692342 1 Dose Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.
11008824|NCT01098474|BG002|Baseline|Control Menjugate Group|Subjects received three doses of the control Menjugate™ vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.
11008825|NCT01098474|BG003|Baseline|SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered instramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008826|NCT01098474|BG004|Baseline|SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008827|NCT01098474|BG005|Baseline|Control Tritanrix + Prevnar + Polio Sabin Group|Subjects received three doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008828|NCT01098474|BG006|Baseline|Total|Total of all reporting groups
11008829|NCT01098474|FG000|Participant Flow|SB692342 2 Dose Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, on a 0, 1 month schedule after having completed their primary EPI regimen.
11008830|NCT01098474|FG001|Participant Flow|SB692342 1 Dose Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.
11008831|NCT01098474|FG002|Participant Flow|Control Menjugate Group|Subjects received three doses of the control Menjugate™ vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.
11008832|NCT01098474|FG003|Participant Flow|SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered instramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008833|NCT01098474|FG004|Participant Flow|SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008834|NCT01098474|FG005|Participant Flow|Control Tritanrix + Prevnar + Polio Sabin Group|Subjects received three doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008835|NCT01098474|OG000|Outcome|SB692342 2 Dose Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, on a 0, 1 month schedule after having completed their primary EPI regimen.
11134993|NCT01784211|FG004|Participant Flow|First Glargine + Exercise, Then Glargine Alone (Part B)|0.5 U/kg insulin glargine SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 17 (no exercise on Day 20).
11134994|NCT01784211|FG005|Participant Flow|First Glargine Alone, Then Glargine + Exercise (Part B)|0.5 U/kg insulin glargine SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 20 (no exercise on Day 17).
11134995|NCT01784211|OG000|Outcome|LY2605541 (Part A)|0.5 U/kg LY2605541 SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
11134996|NCT01784211|OG001|Outcome|Glargine (Part A)|0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
11134997|NCT01784211|OG000|Outcome|LY2605541 + Exercise (Part B)|0.5 U/kg LY2605541 SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20.
11134998|NCT01784211|OG001|Outcome|LY2605541 (Part B)|0.5 U/kg LY2605541 SC once daily for an additional 6 days.
11134999|NCT01784211|OG002|Outcome|Glargine + Exercise (Part B)|0.5 U/kg insulin glargine SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20.
11135000|NCT01784211|OG003|Outcome|Glargine (Part B)|0.5 U/kg insulin glargine SC once daily for an additional 6 days.
11135001|NCT01784211|OG001|Outcome|LY2605541 - No Exercise (Part B)|0.5 U/kg LY2605541 SC once daily for an additional 6 days.
11135002|NCT01784211|OG003|Outcome|Glargine - No Exercise (Part B)|0.5 U/kg insulin glargine SC once daily for an additional 6 days.
11135003|NCT01784211|EG000|Reported Event|LY2605541 (Part A and Part B)|"Part A: 0.5 U/kg LY2605541 SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.~Participants who completed Part A and met certain criteria had the option of continuing to Part B.~Part B: 0.5 U/kg LY2605541 SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20."
11135004|NCT01784211|EG001|Reported Event|Glargine (Part A and Part B)|"Part A: 0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.~Participants who completed Part A and met certain criteria had the option of continuing to Part B.~Part B: 0.5 U/kg insulin glargine SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20."
11135005|NCT01784419|BG000|Baseline|All Study Participants|"The ivacaftor-placebo arm receives a 2 week course of ivacaftor 150 mg twice daily followed by a 2 week washout period followed by a 2 week placebo course.~The placebo-ivacaftor arm receives a 2 week placebo course followed by a 2 week washout period followed by a 2 week course of ivacaftor 150 mg twice daily."
11135006|NCT01784419|FG000|Participant Flow|All Study Participants|"The ivacaftor-placebo arm receives a 2 week course of ivacaftor 150 mg twice daily followed by a 2 week washout period followed by a 2 week placebo course.~The placebo-ivacaftor arm receives a 2 week placebo course followed by a 2 week washout period followed by a 2 week course of ivacaftor 150 mg twice daily."
11135007|NCT01784419|OG000|Outcome|All Study Participants|"The ivacaftor-placebo arm receives a 2 week course of ivacaftor 150 mg twice daily followed by a 2 week washout period followed by a 2 week placebo course.~The placebo-ivacaftor arm receives a 2 week placebo course followed by a 2 week washout period followed by a 2 week course of ivacaftor 150 mg twice daily."
11135008|NCT01784419|EG000|Reported Event|All Study Participants|"The ivacaftor-placebo arm receives a 2 week course of ivacaftor 150 mg twice daily followed by a 2 week washout period followed by a 2 week placebo course.~The placebo-ivacaftor arm receives a 2 week placebo course followed by a 2 week washout period followed by a 2 week course of ivacaftor 150 mg twice daily."
11135009|NCT01784523|BG000|Baseline|Standard Treatment|patients randomized to standard treatment will not receive hydroxychloroquine.
11135010|NCT01784523|BG001|Baseline|Hydroxychloroquine|"Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.~Hydroxychloroquine"
11135011|NCT01784523|BG002|Baseline|Total|Total of all reporting groups
11135012|NCT01784523|FG000|Participant Flow|Standard Treatment|patients randomized to standard treatment will not receive hydroxychloroquine.
11135013|NCT01784523|FG001|Participant Flow|Hydroxychloroquine|"Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.~Hydroxychloroquine"
11135014|NCT01784523|OG000|Outcome|Standard Treatment|patients randomized to standard treatment will not receive hydroxychloroquine.
11135015|NCT01784523|OG001|Outcome|Hydroxychloroquine|"Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.~Hydroxychloroquine"
11135016|NCT01784523|EG000|Reported Event|Standard Treatment|patients randomized to standard treatment will not receive hydroxychloroquine.
11135017|NCT01784523|EG001|Reported Event|Hydroxychloroquine|"Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.~Hydroxychloroquine"
11135018|NCT01784588|BG000|Baseline|Solyx Single Incision Sling System|"Solyx Single Incision Sling System~Solyx Single Incision Sling System: Solyx Single Incision Sling System"
11135019|NCT01784588|BG001|Baseline|Obtryx II Sling System|"Obtryx II Sling System~Obtryx II Sling System: Standard outside-in transobturator sling"
11135020|NCT01784588|BG002|Baseline|Total|Total of all reporting groups
11135021|NCT01784588|FG000|Participant Flow|Solyx Single Incision Sling System|"Solyx Single Incision Sling System~Solyx Single Incision Sling System: Solyx Single Incision Sling System"
11135022|NCT01784588|FG001|Participant Flow|Obtryx II Sling System|"Obtryx II Sling System~Obtryx II Sling System: Standard outside-in transobturator sling"
11135023|NCT01784588|OG000|Outcome|Solyx Single Incision Sling System|"Solyx Single Incision Sling System~Solyx Single Incision Sling System: Solyx Single Incision Sling System"
11135024|NCT01784588|OG001|Outcome|Obtryx II Sling System|"Obtryx II Sling System~Obtryx II Sling System: Standard outside-in transobturator sling"
11135025|NCT01784588|EG000|Reported Event|Solyx Single Incision Sling System|"Solyx Single Incision Sling System~Solyx Single Incision Sling System: Solyx Single Incision Sling System"
11135026|NCT01784588|EG001|Reported Event|Obtryx II Sling System|"Obtryx II Sling System~Obtryx II Sling System: Standard outside-in transobturator sling"
11008836|NCT01098474|OG001|Outcome|SB692342 1 Dose Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.
11008837|NCT01098474|OG002|Outcome|Control Menjugate Group|Subjects received three doses of the control Menjugate™ vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.
11008838|NCT01098474|OG000|Outcome|SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered instramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008839|NCT01098474|OG001|Outcome|SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008840|NCT01098474|OG002|Outcome|Control Tritanrix + Prevnar + Polio Sabin Group|Subjects received three doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008841|NCT01098474|OG001|Outcome|SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered instramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008842|NCT01098474|OG002|Outcome|SB692342 1 Dose Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.
11008843|NCT01098474|OG003|Outcome|SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008844|NCT01098474|OG004|Outcome|Control Menjugate Group|Subjects received three doses of the control Menjugate™ vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.
11008845|NCT01098474|OG005|Outcome|Control Tritanrix + Prevnar + Polio Sabin Group|Subjects received three doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008846|NCT01098474|OG002|Outcome|SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008847|NCT01098474|OG003|Outcome|Control Menjugate Group|Subjects received three doses of the control Menjugate™ vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.
11008848|NCT01098474|OG004|Outcome|Control Tritanrix + Prevnar + Polio Sabin Group|Subjects received three doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11135027|NCT01784614|BG000|Baseline|Overall|"Single dose of 0.1 mg LY2624803 oral solution plus 1 placebo capsule, one 1.0, 3.0 or 6.0 mg LY2624803 capsule plus placebo solution administered orally in up to 2 of 4 periods or 1 placebo capsule plus placebo solution administered orally in up to 1 of 4 periods.~There was at least 7 days washout between each period."
11135028|NCT01784614|FG000|Participant Flow|Cohort 1|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 2: Single dose of one 1.0 milligram (mg) LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
11135029|NCT01784614|FG001|Participant Flow|Cohort 2|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 3: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
11135030|NCT01784614|FG002|Participant Flow|Cohort 3|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
11135031|NCT01784614|FG003|Participant Flow|Cohort 4|"Period 1: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
11135032|NCT01784614|FG004|Participant Flow|Cohort 5|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 2: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
11135033|NCT01784614|FG005|Participant Flow|Cohort 6|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 3: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
11135034|NCT01784614|FG006|Participant Flow|Cohort 7|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
11135035|NCT01784614|FG007|Participant Flow|Cohort 8|"Period 1: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of 1.0 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
11135036|NCT01784614|OG000|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
11135037|NCT01784614|OG001|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
11135038|NCT01784614|OG002|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
11135039|NCT01784614|OG003|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
11135040|NCT01784614|OG004|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
11135041|NCT01784614|OG000|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
11135042|NCT01784614|OG001|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
11135043|NCT01784614|OG002|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
11135044|NCT01784614|OG003|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
11135045|NCT01784614|EG000|Reported Event|0.1 mg LY2624803 - Periods 1-3|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
11135046|NCT01784614|EG001|Reported Event|1.0 mg LY2624803 - Periods 1-3|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
11135047|NCT01784614|EG002|Reported Event|3.0 mg LY2624803 - Periods 1-3|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
11135048|NCT01784614|EG003|Reported Event|6.0 mg LY2624803 - Periods 1-3|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
11135049|NCT01784614|EG004|Reported Event|Placebo - Periods 1-3|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
11135050|NCT01784614|EG005|Reported Event|0.1 mg LY2624803 - Period 4|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4.
11135051|NCT01784614|EG006|Reported Event|1.0 mg LY2624803 - Period 4|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
11135052|NCT01784614|EG007|Reported Event|3.0 mg LY2624803 - Period 4|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
10887370|NCT00500240|OG000|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
11135053|NCT01784614|EG008|Reported Event|6 mg LY2624803 - Period 4|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
11135054|NCT01784666|BG000|Baseline|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135055|NCT01784666|BG001|Baseline|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135056|NCT01784666|BG002|Baseline|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135057|NCT01784666|BG003|Baseline|Total|Total of all reporting groups
11135058|NCT01784666|FG000|Participant Flow|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135059|NCT01784666|FG001|Participant Flow|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135060|NCT01784666|FG002|Participant Flow|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135061|NCT01784666|OG000|Outcome|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135062|NCT01784666|OG001|Outcome|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135063|NCT01784666|OG002|Outcome|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135064|NCT01784666|EG000|Reported Event|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135065|NCT01784666|EG001|Reported Event|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135066|NCT01784666|EG002|Reported Event|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
11135067|NCT01784770|BG000|Baseline|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
11135068|NCT01784770|FG000|Participant Flow|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
11135069|NCT01784770|OG000|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
11135070|NCT01784770|EG000|Reported Event|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
11135071|NCT01784796|BG000|Baseline|Mindfulness Based Stress Reduction|"8 week Mindfulness Based Stress Reduction program~Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program"
11135072|NCT01784796|BG001|Baseline|Health Education Program|"8 week Health Education program~Health Education Program: 8 week Health Education Program"
11135073|NCT01784796|BG002|Baseline|Total|Total of all reporting groups
11135074|NCT01784796|FG000|Participant Flow|Mindfulness Based Stress Reduction|8 week Mindfulness Based Stress Reduction program
11135075|NCT01784796|FG001|Participant Flow|Health Education Program|"8 week Health Education program~Health Education Program: 8 week Health Education Program"
11135076|NCT01784796|OG000|Outcome|Mindfulness Based Stress Reduction|"8 week Mindfulness Based Stress Reduction program~Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program"
11135077|NCT01784796|OG001|Outcome|Health Education Program|"8 week Health Education program~Health Education Program: 8 week Health Education Program"
11135078|NCT01784796|OG000|Outcome|Mindfulness Based Stress Reduction|8 week Mindfulness Based Stress Reduction program
11135079|NCT01784796|EG000|Reported Event|Mindfulness Based Stress Reduction|"8 week Mindfulness Based Stress Reduction program~Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program"
11135080|NCT01784796|EG001|Reported Event|Health Education Program|"8 week Health Education program~Health Education Program: 8 week Health Education Program"
11135081|NCT01784861|BG000|Baseline|Phase I Dose Level 0: X-82 + Everolimus|"X-82 100 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135082|NCT01784861|BG001|Baseline|Phase I Dose Level 1: X-82 + Everolimus|"X-82 150 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135083|NCT01784861|BG002|Baseline|Phase I Dose Level 2: X-82 + Everolimus|"X-82 200 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135084|NCT01784861|BG003|Baseline|Phase I Dose Level 3: X-82 + Everolimus|"X-82 300 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135085|NCT01784861|BG004|Baseline|Phase I Dose Level 4: X-82 + Everolimus|"Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST~X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose~28 days =1 cycle~X-82~Everolimus"
11135086|NCT01784861|BG005|Baseline|Phase II: X-82 + Everolimus|"X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~28 days =1 cycle"
11135087|NCT01784861|BG006|Baseline|Total|Total of all reporting groups
11135088|NCT01784861|FG000|Participant Flow|Phase I Dose Level 0: X-82 + Everolimus|"X-82 100 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135089|NCT01784861|FG001|Participant Flow|Phase I Dose Level 1: X-82 + Everolimus|"X-82 150 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135090|NCT01784861|FG002|Participant Flow|Phase I Dose Level 2: X-82 + Everolimus|"X-82 200 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135091|NCT01784861|FG003|Participant Flow|Phase I Dose Level 3: X-82 + Everolimus|"X-82 300 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135092|NCT01784861|FG004|Participant Flow|Phase I Dose Level 4: X-82 + Everolimus|"Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST~X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose~28 days =1 cycle~X-82~Everolimus"
11135093|NCT01784861|FG005|Participant Flow|Phase II: X-82 + Everolimus|"X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~28 days =1 cycle"
11135094|NCT01784861|OG000|Outcome|Phase I Dose Level 0: X-82 + Everolimus|"X-82 100 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135095|NCT01784861|OG001|Outcome|Phase I Dose Level 1: X-82 + Everolimus|"X-82 150 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135096|NCT01784861|OG002|Outcome|Phase I Dose Level 2: X-82 + Everolimus|"X-82 200 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135097|NCT01784861|OG003|Outcome|Phase I Dose Level 3: X-82 + Everolimus|"X-82 300 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135098|NCT01784861|OG004|Outcome|Phase I Dose Level 4: X-82 + Everolimus|"Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST~X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose~28 days =1 cycle~X-82~Everolimus"
11135099|NCT01784861|OG005|Outcome|Phase II: X-82 + Everolimus|"X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~28 days =1 cycle"
11135100|NCT01784861|OG000|Outcome|Phase I All Dose Levels: X-82 + Everolimus|"X-82 by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135101|NCT01784861|OG001|Outcome|Phase II: X-82 + Everolimus|"X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~28 days =1 cycle"
11135102|NCT01784861|EG000|Reported Event|Phase I Dose Level 0: X-82 + Everolimus|"X-82 100 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135103|NCT01784861|EG001|Reported Event|Phase I Dose Level 1: X-82 + Everolimus|"X-82 150 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135104|NCT01784861|EG002|Reported Event|Phase I Dose Level 2: X-82 + Everolimus|"X-82 200 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135105|NCT01784861|EG003|Reported Event|Phase I Dose Level 3: X-82 + Everolimus|"X-82 300 mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~Everolimus and X-82 should be taken at the same time every day~28 days =1 cycle"
11135106|NCT01784861|EG004|Reported Event|Phase I Dose Level 4: X-82 + Everolimus|"Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST~X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose~28 days =1 cycle~X-82~Everolimus"
11135107|NCT01784861|EG005|Reported Event|Phase II: X-82 + Everolimus|"X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily~Everolimus 10mg by mouth once daily for each cycle~28 days =1 cycle"
11135108|NCT01784926|BG000|Baseline|IOL Repositioning|Operation method: Intraocular lens repositioning by scleral suturing
11135109|NCT01784926|BG001|Baseline|IOL Exchange|Operation method: Intraocular lens exchange with retropupillary iris-claw lens
11135110|NCT01784926|BG002|Baseline|Total|Total of all reporting groups
11135111|NCT01784926|FG000|Participant Flow|IOL Repositioning|"Operation method: Intraocular lens repositioning by scleral suturing~54 patients were randomised to this group. 11 patients were lost to follow-up before the 6-month postoperative visit because of serious illness and 1 death (unrelated to the condition studied)."
11135112|NCT01784926|FG001|Participant Flow|IOL Exchange|"Operation method: Intraocular lens exchange with retropupillary iris-claw lens~50 patients were randomised to this group. 8 patients were lost to follow-up before the 6-month postoperative visit because of serious illness (unrelated to the condition studied)."
11135113|NCT01784926|OG000|Outcome|IOL Repositioning|Operation method: Intraocular lens repositioning by scleral suturing
11135114|NCT01784926|OG001|Outcome|IOL Exchange|Operation method: Intraocular lens exchange with retropupillary iris-claw lens
11135115|NCT01784926|EG000|Reported Event|IOL Repositioning|Operation method: Intraocular lens repositioning by scleral suturing
11135116|NCT01784926|EG001|Reported Event|IOL Exchange|Operation method: Intraocular lens exchange with retropupillary iris-claw lens
11135117|NCT01784965|BG000|Baseline|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
11135118|NCT01784965|BG001|Baseline|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
11135119|NCT01784965|BG002|Baseline|Total|Total of all reporting groups
11135120|NCT01784965|FG000|Participant Flow|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
11135121|NCT01784965|FG001|Participant Flow|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
11135122|NCT01784965|OG000|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
11135123|NCT01784965|OG001|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
11135124|NCT01784965|OG000|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
11008849|NCT01098474|OG001|Outcome|Control Menjugate Group|Subjects received three doses of the control Menjugate™ vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.
11008850|NCT01098474|OG000|Outcome|SB692342 1 Dose Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.
11008851|NCT01098474|EG000|Reported Event|SB692342 2 Dose Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, on a 0, 1 month schedule after having completed their primary EPI regimen.
11008852|NCT01098474|EG001|Reported Event|SB692342 1 Dose Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.
11008853|NCT01098474|EG002|Reported Event|Control Menjugate Group|Subjects received three doses of the control Menjugate™ vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.
11008854|NCT01098474|EG003|Reported Event|SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered instramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008855|NCT01098474|EG004|Reported Event|SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group|Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008856|NCT01098474|EG005|Reported Event|Control Tritanrix + Prevnar + Polio Sabin Group|Subjects received three doses of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™ vaccine, administered in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar® vaccine administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix™ HepB+Hiberix™, Polio Sabin™ and Prevnar® vaccines approximately 1 year after their last dose.
11008857|NCT01098487|BG000|Baseline|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
11008858|NCT01098487|FG000|Participant Flow|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
11008859|NCT01098487|OG000|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
11008860|NCT01098487|EG000|Reported Event|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
11008861|NCT01098500|BG000|Baseline|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
11067012|NCT01394718|OG000|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
11135125|NCT01784965|OG001|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
11135126|NCT01784965|EG000|Reported Event|Liraglutide|Intolerable gastrointestinal side effects 3/35 injection site reaction 2/35 pneumonia 1/35 gallstone 1/35 fall 1/35
11135127|NCT01784965|EG001|Reported Event|Placebo|0/33 0/33 0/33 0/33 0/33
11135128|NCT01785069|BG000|Baseline|Augmentation|Women who had breast augmentation with NATRELLE® 410 implants.
11135129|NCT01785069|BG001|Baseline|Revision-Augmentation|Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
11135130|NCT01785069|BG002|Baseline|Reconstruction|Women who had breast reconstruction with NATRELLE® 410 implants.
11135131|NCT01785069|BG003|Baseline|Revision-Reconstruction|Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
11135132|NCT01785069|BG004|Baseline|Total|Total of all reporting groups
11135133|NCT01785069|FG000|Participant Flow|Augmentation|Women who had breast augmentation with NATRELLE® 410 implants.
11135134|NCT01785069|FG001|Participant Flow|Revision-Augmentation|Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
11135135|NCT01785069|FG002|Participant Flow|Reconstruction|Women who had breast reconstruction with NATRELLE® 410 implants.
11135136|NCT01785069|FG003|Participant Flow|Revision-Reconstruction|Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
11135137|NCT01785069|OG000|Outcome|Augmentation|Women who had breast augmentation with NATRELLE® 410 implants.
11135138|NCT01785069|OG001|Outcome|Revision-Augmentation|Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
11135139|NCT01785069|OG002|Outcome|Reconstruction|Women who had breast reconstruction with NATRELLE® 410 implants.
11135140|NCT01785069|OG003|Outcome|Revision-Reconstruction|Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
11135141|NCT01785069|EG000|Reported Event|Augmentation|Women who had breast augmentation with NATRELLE® 410 implants.
11135142|NCT01785069|EG001|Reported Event|Reconstruction|Women who had breast reconstruction with NATRELLE® 410 implants.
11135143|NCT01785069|EG002|Reported Event|Revision-Augmentation|Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
11135144|NCT01785069|EG003|Reported Event|Revision-Reconstruction|Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
11135145|NCT01785095|BG000|Baseline|Follicle Stimulating Hormone|
11135146|NCT01785095|FG000|Participant Flow|Follicle Stimulation Hormone|"FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.~FSH (Follicle Stimulating Hormone)"
11135147|NCT01785095|OG000|Outcome|Follicle Stimulationg Hormone|
11135148|NCT01785095|OG000|Outcome|First Cycle|First treatment cycle.
11135149|NCT01785095|OG001|Outcome|Second Cycle|Second treatment cycle performed after 1 month of wash out.
11135150|NCT01785095|OG001|Outcome|Second Cycle|Second treatment cycle after 1 month of wash out.
11135151|NCT01785095|EG000|Reported Event|Follicle Stimulating Hormone|
11135152|NCT01785134|BG000|Baseline|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
11135153|NCT01785134|BG001|Baseline|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
11135154|NCT01785134|BG002|Baseline|Total|Total of all reporting groups
11135155|NCT01785134|FG000|Participant Flow|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
11135156|NCT01785134|FG001|Participant Flow|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
11135157|NCT01785134|OG000|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
11135158|NCT01785134|OG001|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
11135159|NCT01785134|EG000|Reported Event|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
11135160|NCT01785134|EG001|Reported Event|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
11135161|NCT01785160|BG000|Baseline|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir The two treatments were separated by washout period of at least 7 days.
11135162|NCT01785160|FG000|Participant Flow|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir. The two treatments were separated by washout period of at least 7 days.
11135163|NCT01785160|OG000|Outcome|Raltegravir|"Raltegravir coated tablets~Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
11135164|NCT01785160|OG001|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules~Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
11135165|NCT01785160|EG000|Reported Event|Raltegravir|"coated tablets, oral administration with 240 ml water~Raltegravir: low dose oral administration"
11135166|NCT01785160|EG001|Reported Event|Raltegravir + Faldaprevir|"coated tablets and soft gelatine capsule, oral administration with 240 ml water~Raltegravir: low dose oral administration~Faldaprevir: medium dose oral administration"
11135167|NCT01785186|BG000|Baseline|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11008862|NCT01098500|FG000|Participant Flow|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
11008863|NCT01098500|OG000|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
11008864|NCT01098500|EG000|Reported Event|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
11008865|NCT01098539|BG000|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
11008866|NCT01098539|BG001|Baseline|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
11008867|NCT01098539|BG002|Baseline|Total|Total of all reporting groups
11008868|NCT01098539|FG000|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
11008869|NCT01098539|FG001|Participant Flow|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
11008870|NCT01098539|OG000|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
11008871|NCT01098539|OG001|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
11008872|NCT01098539|EG000|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
11008873|NCT01098539|EG001|Reported Event|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
11008874|NCT01098578|BG000|Baseline|Floseal|"Received Floseal treatment for posterior epistaxis.~Floseal : Received Floseal as treatment for posterior epistaxis."
11008875|NCT01098578|FG000|Participant Flow|Floseal.|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion.
11008876|NCT01098578|OG000|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
11008877|NCT01098578|OG000|Outcome|FLOSEAL|Institutional cost of treating all study patients with Floseal for posterior epistaxis
11008878|NCT01098578|OG001|Outcome|Endoscopic Surgery|The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
11008879|NCT01098578|EG000|Reported Event|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
11008880|NCT01098747|BG000|Baseline|Placebo|Single oral dose of 2 placebo tablets.
11008881|NCT01098747|BG001|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
11008882|NCT01098747|BG002|Baseline|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
11008883|NCT01098747|BG003|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
11008884|NCT01098747|BG004|Baseline|Total|Total of all reporting groups
11008885|NCT01098747|FG000|Participant Flow|Placebo|Single oral dose of 2 placebo tablets.
11008886|NCT01098747|FG001|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
11008887|NCT01098747|FG002|Participant Flow|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
11008888|NCT01098747|FG003|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
11008889|NCT01098747|OG000|Outcome|Placebo|Single oral dose of 2 placebo tablets.
11008890|NCT01098747|OG001|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
11008891|NCT01098747|OG002|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
11008892|NCT01098747|EG000|Reported Event|Placebo|Single oral dose of 2 placebo tablets.
11008893|NCT01098747|EG001|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
11008894|NCT01098747|EG002|Reported Event|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
11008895|NCT01098747|EG003|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
11008896|NCT01098812|BG000|Baseline|ZCB00|Approved Intraocular control lens
11008897|NCT01098812|BG001|Baseline|Toric IOL|Investigational Toric IOL
11008898|NCT01098812|BG002|Baseline|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
11008899|NCT01098812|BG003|Baseline|Total|Total of all reporting groups
11008900|NCT01098812|FG000|Participant Flow|ZCB00|Approved Intraocular control lens
11008901|NCT01098812|FG001|Participant Flow|Toric IOL|Investigational Toric IOL
11008902|NCT01098812|FG002|Participant Flow|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
11008903|NCT01098812|OG000|Outcome|Control IOL|Approved Intraocular control lens
11008904|NCT01098812|OG001|Outcome|Toric IOL|Investigational Toric IOL
11008905|NCT01098812|OG002|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
11008906|NCT01098812|EG000|Reported Event|ZCB00|Approved Intraocular control lens
11008907|NCT01098812|EG001|Reported Event|All Toric IOLs|Investigational Toric IOLs including high cylinder powers
11008908|NCT01098851|BG000|Baseline|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
11008909|NCT01098851|BG001|Baseline|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
11008910|NCT01098851|BG002|Baseline|Total|Total of all reporting groups
11008911|NCT01098851|FG000|Participant Flow|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
11008912|NCT01098851|FG001|Participant Flow|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
11008913|NCT01098851|OG000|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
11008914|NCT01098851|OG001|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
11008915|NCT01098851|EG000|Reported Event|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
11008916|NCT01098851|EG001|Reported Event|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
11135168|NCT01785186|BG001|Baseline|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135169|NCT01785186|BG002|Baseline|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135170|NCT01785186|BG003|Baseline|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135171|NCT01785186|BG004|Baseline|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135172|NCT01785186|BG005|Baseline|Total|Total of all reporting groups
11135173|NCT01785186|FG000|Participant Flow|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135174|NCT01785186|FG001|Participant Flow|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135175|NCT01785186|FG002|Participant Flow|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135176|NCT01785186|FG003|Participant Flow|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135177|NCT01785186|FG004|Participant Flow|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135178|NCT01785186|OG000|Outcome|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135179|NCT01785186|OG001|Outcome|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135180|NCT01785186|OG002|Outcome|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135181|NCT01785186|OG003|Outcome|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135182|NCT01785186|OG004|Outcome|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135183|NCT01785186|OG000|Outcome|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135184|NCT01785186|OG001|Outcome|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135185|NCT01785186|EG000|Reported Event|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135186|NCT01785186|EG001|Reported Event|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135187|NCT01785186|EG002|Reported Event|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135188|NCT01785186|EG003|Reported Event|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
11135189|NCT01785186|EG004|Reported Event|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
11135190|NCT01785459|BG000|Baseline|Standard Care|"intravenous Prochlorperazine~Standard Care: 10 mg Intravenous injection of Prochlorperazine"
11135191|NCT01785459|BG001|Baseline|Treatment|"0.5% bupivacaine~0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection."
11135192|NCT01785459|BG002|Baseline|Total|Total of all reporting groups
11135193|NCT01785459|FG000|Participant Flow|Standard Care|"intravenous Prochlorperazine~Standard Care: 10 mg Intravenous injection of Prochlorperazine"
11135194|NCT01785459|FG001|Participant Flow|Treatment|"0.5% bupivacaine~0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection."
11135195|NCT01785459|OG000|Outcome|Standard Care|"intravenous Prochlorperazine~Standard Care: 10 mg Intravenous injection of Prochlorperazine"
11135196|NCT01785459|OG001|Outcome|Treatment|"0.5% bupivacaine~0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection."
11135197|NCT01785459|EG000|Reported Event|Standard Care|"intravenous Prochlorperazine~Standard Care: 10 mg Intravenous injection of Prochlorperazine"
11135198|NCT01785459|EG001|Reported Event|Treatment|"0.5% bupivacaine~0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection."
11149644|NCT01871870|BG000|Baseline|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
11149645|NCT01871870|FG000|Participant Flow|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
11149646|NCT01871870|OG000|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
11149647|NCT01871870|EG000|Reported Event|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
11149648|NCT01872078|BG000|Baseline|Placebo|Two matching placebo tablets for both the morning and evening doses
11149649|NCT01872078|BG001|Baseline|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
11149650|NCT01872078|BG002|Baseline|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
11149651|NCT01872078|BG003|Baseline|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
11149652|NCT01872078|BG004|Baseline|Total|Total of all reporting groups
11149653|NCT01872078|FG000|Participant Flow|Placebo|Two matching placebo tablets for both the morning and evening doses
11149654|NCT01872078|FG001|Participant Flow|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
11149655|NCT01872078|FG002|Participant Flow|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
11008917|NCT01099111|BG000|Baseline|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008918|NCT01099111|BG001|Baseline|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008919|NCT01099111|BG002|Baseline|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008920|NCT01099111|BG003|Baseline|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008921|NCT01099111|BG004|Baseline|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008922|NCT01099111|BG005|Baseline|Total|Total of all reporting groups
11008923|NCT01099111|FG000|Participant Flow|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008924|NCT01099111|FG001|Participant Flow|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008925|NCT01099111|FG002|Participant Flow|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11135199|NCT01785472|BG000|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
11135200|NCT01785472|BG001|Baseline|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
11135201|NCT01785472|BG002|Baseline|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
11135202|NCT01785472|BG003|Baseline|Total|Total of all reporting groups
11135203|NCT01785472|FG000|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
11135204|NCT01785472|FG001|Participant Flow|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
11135205|NCT01785472|FG002|Participant Flow|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
11135206|NCT01785472|OG000|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
11135207|NCT01785472|OG001|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
11135208|NCT01785472|OG000|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
11135209|NCT01785472|OG001|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
11135210|NCT01785472|OG002|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
11135211|NCT01785472|EG000|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily
11135212|NCT01785472|EG001|Reported Event|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
11135213|NCT01785472|EG002|Reported Event|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily
11135214|NCT01785524|BG000|Baseline|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
11135215|NCT01785524|BG001|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
11135216|NCT01785524|BG002|Baseline|Total|Total of all reporting groups
11135217|NCT01785524|FG000|Participant Flow|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
11135218|NCT01785524|FG001|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
11135219|NCT01785524|OG000|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
11135220|NCT01785524|OG001|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
11135221|NCT01785524|EG000|Reported Event|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
11135222|NCT01785524|EG001|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
11135223|NCT01785602|BG000|Baseline|QAW039|Participants received QAW039 450 mg daily by mouth.
11135224|NCT01785602|BG001|Baseline|Placebo|Participants received matching placebo to QAW039.
11135225|NCT01785602|BG002|Baseline|Total|Total of all reporting groups
11135226|NCT01785602|FG000|Participant Flow|QAW039|Participants received QAW039 450 mg daily by mouth.
11135227|NCT01785602|FG001|Participant Flow|Placebo|Participants received matching placebo to QAW039.
11135228|NCT01785602|OG000|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
11135229|NCT01785602|OG001|Outcome|Placebo|Participants received matching placebo to QAW039.
11135230|NCT01785602|EG000|Reported Event|QAW039|Participants received QAW039 450 mg daily by mouth.
11135231|NCT01785602|EG001|Reported Event|Placebo|Participants received matching placebo to QAW039.
11135232|NCT01785615|BG000|Baseline|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
11135233|NCT01785615|BG001|Baseline|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
11135234|NCT01785615|BG002|Baseline|Healthy Participants|
11135235|NCT01785615|BG003|Baseline|Total|Total of all reporting groups
11135236|NCT01785615|FG000|Participant Flow|Atorvastatin|"44 women with metabolic syndrome randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
11135237|NCT01785615|FG001|Participant Flow|Sugar Pill|"44 women with metabolic syndrome randomized to placebo for 6 weeks~Placebo : 80mg"
11135238|NCT01785615|FG002|Participant Flow|Healthy Women|Women without metabolic syndrome
11135239|NCT01785615|FG003|Participant Flow|Metabolic Syndrome Women|These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
11135240|NCT01785615|OG000|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
11135241|NCT01785615|OG001|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
11135242|NCT01785615|OG000|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin: 80mg"
11135243|NCT01785615|OG001|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo: 80mg"
11135244|NCT01785615|OG000|Outcome|Healthy Women|Women without metabolic syndrome
11135245|NCT01785615|OG001|Outcome|Metabolic Syndrome Women|These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
11135246|NCT01785615|OG000|Outcome|Healthy Women|
11135247|NCT01785615|OG001|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
11135248|NCT01785615|EG000|Reported Event|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
11135249|NCT01785615|EG001|Reported Event|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
11135250|NCT01785628|BG000|Baseline|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
11135251|NCT01785628|BG001|Baseline|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
11135252|NCT01785628|BG002|Baseline|Total|Total of all reporting groups
11135253|NCT01785628|FG000|Participant Flow|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
11135254|NCT01785628|FG001|Participant Flow|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
11135255|NCT01785628|OG000|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
11135256|NCT01785628|OG001|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
11135257|NCT01785628|EG000|Reported Event|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
11135258|NCT01785628|EG001|Reported Event|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
11135259|NCT01785680|BG000|Baseline|Integrated Protocol|"Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.~Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m"
11135260|NCT01785680|BG001|Baseline|Current Protocol|"These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.~Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM."
11135261|NCT01785680|BG002|Baseline|Total|Total of all reporting groups
11135262|NCT01785680|FG000|Participant Flow|Integrated Protocol|"Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.~Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m"
11135263|NCT01785680|FG001|Participant Flow|Current Protocol|"These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.~Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM."
11135264|NCT01785680|OG000|Outcome|Integrated Protocol|"Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.~Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m"
11135265|NCT01785680|OG001|Outcome|Current Protocol|"These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.~Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM."
11135266|NCT01785680|EG000|Reported Event|Integrated Protocol|"Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.~Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m"
11135267|NCT01785680|EG001|Reported Event|Current Protocol|"These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.~Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM."
11135268|NCT01785810|BG000|Baseline|Maraviroc|Maraviroc 300 mg
11135269|NCT01785810|FG000|Participant Flow|Maraviroc|Maraviroc - 300 mg
11135270|NCT01785810|OG000|Outcome|Maraviroc|Maraviroc - 300 mg
11135271|NCT01785810|EG000|Reported Event|Maraviroc|Maraviroc - dose level of 300 mg
11135272|NCT01785849|BG000|Baseline|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
11135273|NCT01785849|BG001|Baseline|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
11135274|NCT01785849|BG002|Baseline|Total|Total of all reporting groups
11135275|NCT01785849|FG000|Participant Flow|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
11135276|NCT01785849|FG001|Participant Flow|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
11135277|NCT01785849|OG000|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
11135278|NCT01785849|OG001|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
11135279|NCT01785849|EG000|Reported Event|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
11135280|NCT01785849|EG001|Reported Event|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
11135281|NCT01785875|BG000|Baseline|Etelcalcetide|All participants received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks during the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135282|NCT01785875|FG000|Participant Flow|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135283|NCT01785875|FG001|Participant Flow|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135284|NCT01785875|FG002|Participant Flow|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135285|NCT01785875|OG000|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135286|NCT01785875|OG001|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135287|NCT01785875|OG002|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135288|NCT01785875|OG003|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135289|NCT01785875|OG000|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135290|NCT01785875|EG000|Reported Event|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135291|NCT01785875|EG001|Reported Event|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135292|NCT01785875|EG002|Reported Event|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135293|NCT01785875|EG003|Reported Event|Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
11135294|NCT01786109|BG000|Baseline|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
11135295|NCT01786109|BG001|Baseline|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
11135296|NCT01786109|BG002|Baseline|Placebo|One dose of placebo will be taken orally with water.
11135297|NCT01786109|BG003|Baseline|Total|Total of all reporting groups
11135298|NCT01786109|FG000|Participant Flow|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
11135299|NCT01786109|FG001|Participant Flow|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
11135300|NCT01786109|FG002|Participant Flow|Placebo|One dose of placebo will be taken orally with water.
11135301|NCT01786109|OG000|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
11135302|NCT01786109|OG001|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
11135303|NCT01786109|OG002|Outcome|Placebo|One dose of placebo will be taken orally with water.
11135304|NCT01786109|EG000|Reported Event|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
11135305|NCT01786109|EG001|Reported Event|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
11135306|NCT01786109|EG002|Reported Event|Placebo|One dose of placebo will be taken orally with water.
11135307|NCT01786148|BG000|Baseline|Educational Music Mobile App|"A prerecorded program of songs on various topics in a mobile phone application (app). It is designed to provide education about non-health related topics and will be equivalent in length to the intervention app.~mobile phone application"
11135308|NCT01786148|BG001|Baseline|Live Network Mobile Phone App|"The LN is a prerecorded mobile phone application (app). It employs a radio talk show format in which a Disc Jockey entertains HIV medication-, adherence-, and self-management-related questions and comments from callers and poses them to expert care providers, whose responses to these questions are augmented by songs that shed additional light on these issues.~mobile phone application"
11135309|NCT01786148|BG002|Baseline|Total|Total of all reporting groups
11135310|NCT01786148|FG000|Participant Flow|Educational Music Mobile App|"A prerecorded program of songs on various topics in a mobile phone application (app). It is designed to provide education about non-health related topics and will be equivalent in length to the intervention app.~mobile phone application"
11135311|NCT01786148|FG001|Participant Flow|Live Network Mobile Phone App|"The LN is a prerecorded mobile phone application (app). It employs a radio talk show format in which a Disc Jockey entertains HIV medication-, adherence-, and self-management-related questions and comments from callers and poses them to expert care providers, whose responses to these questions are augmented by songs that shed additional light on these issues.~mobile phone application"
11135312|NCT01786148|OG000|Outcome|Educational Music Mobile App|"A prerecorded program of songs on various topics in a mobile phone application (app). It is designed to provide education about non-health related topics and will be equivalent in length to the intervention app.~mobile phone application"
11135313|NCT01786148|OG001|Outcome|Live Network Mobile Phone App|"The LN is a prerecorded mobile phone application (app). It employs a radio talk show format in which a Disc Jockey entertains HIV medication-, adherence-, and self-management-related questions and comments from callers and poses them to expert care providers, whose responses to these questions are augmented by songs that shed additional light on these issues.~mobile phone application"
11135314|NCT01786148|EG000|Reported Event|Educational Music Mobile App|"A prerecorded program of songs on various topics in a mobile phone application (app). It is designed to provide education about non-health related topics and will be equivalent in length to the intervention app.~mobile phone application"
11135315|NCT01786148|EG001|Reported Event|Live Network Mobile Phone App|"The Live Network (LN) is a prerecorded mobile phone application (app). It employs a radio talk show format in which a Disc Jockey entertains HIV medication-, adherence-, and self-management-related questions and comments from callers and poses them to expert care providers, whose responses to these questions are augmented by songs that shed additional light on these issues.~mobile phone application"
11135316|NCT01786161|BG000|Baseline|Vancomycin Continous Infusion|Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion infusion rate 1000mg/hr
11135317|NCT01786161|BG001|Baseline|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
11135318|NCT01786161|BG002|Baseline|Total|Total of all reporting groups
11135319|NCT01786161|FG000|Participant Flow|Vancomycin With Continuous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
11135320|NCT01786161|FG001|Participant Flow|Vancomycin With Intermittent Dose Interval|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
11135321|NCT01786161|OG000|Outcome|Vancomycin With Continuous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
11135322|NCT01786161|OG001|Outcome|Vancomycin With Intermittent Dose Interval|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
11135323|NCT01786161|OG000|Outcome|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
11135324|NCT01786161|OG001|Outcome|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
11135325|NCT01786161|EG000|Reported Event|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
11135326|NCT01786161|EG001|Reported Event|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
11135327|NCT01786174|BG000|Baseline|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
11135328|NCT01786174|BG001|Baseline|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
11135329|NCT01786174|BG002|Baseline|Total|Total of all reporting groups
11149656|NCT01872078|FG003|Participant Flow|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
11135330|NCT01786174|FG000|Participant Flow|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
11135331|NCT01786174|FG001|Participant Flow|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
11135332|NCT01786174|OG000|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
11135333|NCT01786174|OG001|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
11135334|NCT01786174|EG000|Reported Event|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
11135335|NCT01786174|EG001|Reported Event|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
11135336|NCT01786187|BG000|Baseline|Symptom Experience Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.~Symptom Experience Report: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information."
11135337|NCT01786187|BG001|Baseline|Light Physical Activity Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.~Light Physical Activity: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment."
11135338|NCT01786187|BG002|Baseline|Total|Total of all reporting groups
11135339|NCT01786187|FG000|Participant Flow|Symptom Experience Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.~Symptom Experience Report: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information."
11135340|NCT01786187|FG001|Participant Flow|Light Physical Activity Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.~Light Physical Activity: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment."
11135341|NCT01786187|OG000|Outcome|All Participants Recruited|All Participants Recruited.
11135342|NCT01786187|OG000|Outcome|Light Physical Activity Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.~Light Physical Activity: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment."
11135343|NCT01786187|OG001|Outcome|Symptom Experience Group|Standard of Care
11135344|NCT01786187|OG000|Outcome|Symptom Experience Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.~Symptom Experience Report: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information."
11135345|NCT01786187|OG001|Outcome|Light Physical Activity Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.~Light Physical Activity: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment."
11135346|NCT01786187|EG000|Reported Event|Symptom Experience Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.~Symptom Experience Report: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information."
11135347|NCT01786187|EG001|Reported Event|Light Physical Activity Group|"Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.~Light Physical Activity: Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment."
11135348|NCT01786239|BG000|Baseline|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
11149657|NCT01872078|OG000|Outcome|Placebo|Two matching placebo tablets for both the morning and evening doses
11149658|NCT01872078|OG001|Outcome|20 mg AZD4901 qd|20 mg AZD4901 once daily administered orally
11135349|NCT01786239|BG001|Baseline|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
11135350|NCT01786239|BG002|Baseline|Total|Total of all reporting groups
11135351|NCT01786239|FG000|Participant Flow|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
11135352|NCT01786239|FG001|Participant Flow|Amber50/50 Soybean Corn Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Amber 50/50 Soybean/Corn Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
11135353|NCT01786239|OG000|Outcome|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
11135354|NCT01786239|OG001|Outcome|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
11135355|NCT01786239|EG000|Reported Event|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
11135356|NCT01786239|EG001|Reported Event|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
11135357|NCT01786252|BG000|Baseline|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
11135358|NCT01786252|BG001|Baseline|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
11135359|NCT01786252|BG002|Baseline|Total|Total of all reporting groups
11135360|NCT01786252|FG000|Participant Flow|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
11135361|NCT01786252|FG001|Participant Flow|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
11149659|NCT01872078|OG002|Outcome|20 mg AZD4901 Bid|20 mg AZD4901 twice daily administered orally
11149660|NCT01872078|OG003|Outcome|40 mg AZD4901 Bid|40 mg AZD4901 twice daily administered orally
11149661|NCT01872078|EG000|Reported Event|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
11135362|NCT01786252|OG000|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
11135363|NCT01786252|OG001|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
11135364|NCT01786252|EG000|Reported Event|"IVF Media (Global-Trademark)"|Received IVF media infusion on Day 3 Post-Ovulation Induction
11135365|NCT01786252|EG001|Reported Event|Drug: Human Chorionic Gonadotropin (hCG)|Received hCG infusion on Day 3 Post-Ovulation Induction
11135366|NCT01786330|BG000|Baseline|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
11135367|NCT01786330|BG001|Baseline|Control|"Group receives standard of care~Standard of Care"
11135368|NCT01786330|BG002|Baseline|Total|Total of all reporting groups
11135369|NCT01786330|FG000|Participant Flow|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
11135370|NCT01786330|FG001|Participant Flow|Control|"Group receives standard of care~Standard of Care"
11135371|NCT01786330|OG000|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
11135372|NCT01786330|OG001|Outcome|Control|"Group receives standard of care~Standard of Care"
11135373|NCT01786330|EG000|Reported Event|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
11135374|NCT01786330|EG001|Reported Event|Control|"Group receives standard of care~Standard of Care"
11135375|NCT01786343|BG000|Baseline|Decitabine - 5 Day Regimen|"Decitabine 20 mg/m2 by vein daily for 5 days.~Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days."
11135376|NCT01786343|BG001|Baseline|Decitabine - 10 Day Regimen|"Decitabine 20 mg/m2 by vein daily for 10 days.~Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days."
11135377|NCT01786343|BG002|Baseline|Total|Total of all reporting groups
11135378|NCT01786343|FG000|Participant Flow|Decitabine - 5 Day Regimen|"Decitabine 20 mg/m2 by vein daily for 5 days.~Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days."
11135379|NCT01786343|FG001|Participant Flow|Decitabine - 10 Day Regimen|"Decitabine 20 mg/m2 by vein daily for 10 days.~Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days."
11135380|NCT01786343|OG000|Outcome|Decitabine - 5 Day Regimen|"Decitabine 20 mg/m2 by vein daily for 5 days.~Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days."
11135381|NCT01786343|OG001|Outcome|Decitabine - 10 Day Regimen|"Decitabine 20 mg/m2 by vein daily for 10 days.~Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days."
11135382|NCT01786343|EG000|Reported Event|Decitabine - 5 Day Regimen|"Decitabine 20 mg/m2 by vein daily for 5 days.~Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days."
11135383|NCT01786343|EG001|Reported Event|Decitabine - 10 Day Regimen|"Decitabine 20 mg/m2 by vein daily for 10 days.~Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days."
11135384|NCT01786512|BG000|Baseline|Dose-escalation Cohort 1: Placebo|Participants received placebo tablets twice a day (BID) for 7 days.
11135385|NCT01786512|BG001|Baseline|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1|Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
11135386|NCT01786512|BG002|Baseline|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2|Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
11135387|NCT01786512|BG003|Baseline|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2|Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
11135388|NCT01786512|BG004|Baseline|Dose-escalation Cohort 2: Placebo|Participants received placebo tablets twice a day for 7 days.
11135389|NCT01786512|BG005|Baseline|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1|Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
11135390|NCT01786512|BG006|Baseline|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2|Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
11135391|NCT01786512|BG007|Baseline|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2|Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
11135392|NCT01786512|BG008|Baseline|Expansion Phase: Placebo|Participants received placebo tablets twice a day for 20 weeks.
11135393|NCT01786512|BG009|Baseline|Expansion Phase: Omecamtiv Mecarbil 25 mg|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
11135394|NCT01786512|BG010|Baseline|Expansion Phase: OM PK-based Titration|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
11135395|NCT01786512|BG011|Baseline|Total|Total of all reporting groups
11135396|NCT01786512|FG000|Participant Flow|Dose-escalation Cohort 1: Placebo|Participants received placebo tablets twice a day (BID) for 7 days.
11135397|NCT01786512|FG001|Participant Flow|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1|Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
11135398|NCT01786512|FG002|Participant Flow|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2|Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
11135399|NCT01786512|FG003|Participant Flow|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2|Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
11135400|NCT01786512|FG004|Participant Flow|Dose-escalation Cohort 2: Placebo|Participants received placebo tablets twice a day for 7 days.
11135401|NCT01786512|FG005|Participant Flow|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1|Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
11135402|NCT01786512|FG006|Participant Flow|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2|Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
11135403|NCT01786512|FG007|Participant Flow|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2|Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
11135404|NCT01786512|FG008|Participant Flow|Expansion Phase: Placebo|Participants received placebo tablets twice a day for 20 weeks.
11135405|NCT01786512|FG009|Participant Flow|Expansion Phase: Omecamtiv Mecarbil 25 mg|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
11135406|NCT01786512|FG010|Participant Flow|Expansion Phase: OM PK-based Titration|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
11135407|NCT01786512|OG000|Outcome|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1|Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
11135408|NCT01786512|OG001|Outcome|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2|Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
11135409|NCT01786512|OG002|Outcome|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2|Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
11135410|NCT01786512|OG003|Outcome|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1|Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
11135411|NCT01786512|OG004|Outcome|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2|Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
11135412|NCT01786512|OG005|Outcome|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2|Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
11135413|NCT01786512|OG000|Outcome|Expansion Phase: Omecamtiv Mecarbil 25 mg|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
11135414|NCT01786512|OG001|Outcome|Expansion Phase: OM PK-based Titration|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
11135415|NCT01786512|OG000|Outcome|Expansion Phase: Placebo|Participants received placebo tablets twice a day for 20 weeks.
11135416|NCT01786512|OG001|Outcome|Expansion Phase: Omecamtiv Mecarbil 25 mg|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
11135417|NCT01786512|OG002|Outcome|Expansion Phase: OM PK-based Titration|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
11135418|NCT01786512|OG000|Outcome|Dose-escalation Cohort 1: Placebo|Participants received placebo tablets twice a day (BID) for 7 days.
11135419|NCT01786512|OG001|Outcome|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1|Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
11135420|NCT01786512|OG002|Outcome|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2|Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
11135421|NCT01786512|OG003|Outcome|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2|Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
11135422|NCT01786512|OG004|Outcome|Dose-escalation Cohort 2: Placebo|Participants received placebo tablets twice a day for 7 days.
11135423|NCT01786512|OG005|Outcome|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1|Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
11135424|NCT01786512|OG006|Outcome|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2|Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
11135425|NCT01786512|OG007|Outcome|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2|Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
11135426|NCT01786512|EG000|Reported Event|Dose-escalation Cohort 1: Placebo|Participants received placebo tablets BID for 7 days.
11135427|NCT01786512|EG001|Reported Event|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1|Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
11135428|NCT01786512|EG002|Reported Event|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2|Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
11135429|NCT01786512|EG003|Reported Event|Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2|Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
11135430|NCT01786512|EG004|Reported Event|Dose-escalation Cohort 2: Placebo|Participants received placebo tablets twice a day for 7 days.
11135431|NCT01786512|EG005|Reported Event|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1|Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
11135432|NCT01786512|EG006|Reported Event|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2|Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
11135433|NCT01786512|EG007|Reported Event|Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2|Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
11135434|NCT01786512|EG008|Reported Event|Expansion Phase: Placebo|Participants received placebo tablets twice a day for 20 weeks.
11135435|NCT01786512|EG009|Reported Event|Expansion Phase: Omecamtiv Mecarbil 25 mg|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
11135436|NCT01786512|EG010|Reported Event|Expansion Phase: OM PK-based Titration|Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
11135437|NCT01786551|BG000|Baseline|Eplerenone|Eplerenone 50 mg daily for 14 days
11135438|NCT01786551|FG000|Participant Flow|Eplerenone|Eplerenone 50 mg daily for 14 days
11135439|NCT01786551|OG000|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
11135440|NCT01786551|EG000|Reported Event|Eplerenone|Eplerenone 50 mg daily for 14 days
11135441|NCT01786564|BG000|Baseline|Study Sample|This is a cross-sectional study so there is only one group.
11135442|NCT01786564|FG000|Participant Flow|Study Sample|This is a cross-sectional study so there is only one group.
11135443|NCT01786564|OG000|Outcome|Study Sample|This is a cross-sectional study so there is only one group.
11135444|NCT01786564|EG000|Reported Event|Study Sample|This is a cross-sectional study so there is only one group.
11135445|NCT01786603|BG000|Baseline|Rasagiline|"Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.~Rasagiline: Rasagiline 2mg once a day for 12 months."
11135446|NCT01786603|BG001|Baseline|Placebo|"Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.~Placebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months."
11135447|NCT01786603|BG002|Baseline|Total|Total of all reporting groups
11135448|NCT01786603|FG000|Participant Flow|Rasagiline|"Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.~Rasagiline: Rasagiline 2mg once a day for 12 months."
11135449|NCT01786603|FG001|Participant Flow|Placebo|"Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.~Placebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months."
11135450|NCT01786603|OG000|Outcome|Rasagiline|"Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.~Rasagiline: Rasagiline 2mg once a day for 12 months."
11135451|NCT01786603|OG001|Outcome|Placebo|"Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.~Placebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months."
11135452|NCT01786603|EG000|Reported Event|Rasagiline|"Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.~Rasagiline: Rasagiline 2mg once a day for 12 months."
11135453|NCT01786603|EG001|Reported Event|Placebo|"Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.~Placebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months."
11135454|NCT01786629|BG000|Baseline|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
11135455|NCT01786629|BG001|Baseline|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
11135456|NCT01786629|BG002|Baseline|Total|Total of all reporting groups
11135457|NCT01786629|FG000|Participant Flow|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
11135458|NCT01786629|FG001|Participant Flow|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
11135459|NCT01786629|OG000|Outcome|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
11135460|NCT01786629|OG001|Outcome|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
11135461|NCT01786629|EG000|Reported Event|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
11135462|NCT01786629|EG001|Reported Event|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
11135463|NCT01786668|BG000|Baseline|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
11135464|NCT01786668|BG001|Baseline|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
11135465|NCT01786668|BG002|Baseline|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
11135466|NCT01786668|BG003|Baseline|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
11135467|NCT01786668|BG004|Baseline|Total|Total of all reporting groups
11135468|NCT01786668|FG000|Participant Flow|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning [AM] and afternoon [PM]) for a total of 12 weeks.
11135469|NCT01786668|FG001|Participant Flow|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
11135470|NCT01786668|FG002|Participant Flow|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
11135471|NCT01786668|FG003|Participant Flow|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
11135472|NCT01786668|OG000|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
11135473|NCT01786668|OG001|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
11135474|NCT01786668|OG002|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
11135475|NCT01786668|OG003|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
11135476|NCT01786668|EG000|Reported Event|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
11135477|NCT01786668|EG001|Reported Event|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
11135478|NCT01786668|EG002|Reported Event|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
11135479|NCT01786668|EG003|Reported Event|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
11135480|NCT01786707|BG000|Baseline|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
11135481|NCT01786707|BG001|Baseline|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
11135482|NCT01786707|BG002|Baseline|Total|Total of all reporting groups
11135483|NCT01786707|FG000|Participant Flow|Autologous Stem Cell and HOT|"Autologous stem cells (SC) and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
11135484|NCT01786707|FG001|Participant Flow|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
11135485|NCT01786707|OG000|Outcome|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
11135486|NCT01786707|OG001|Outcome|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
11135487|NCT01786707|EG000|Reported Event|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
10887371|NCT00500240|OG001|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
11135488|NCT01786707|EG001|Reported Event|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
11135489|NCT01786876|BG000|Baseline|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
11135490|NCT01786876|FG000|Participant Flow|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
11135491|NCT01786876|OG000|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
11135492|NCT01786876|EG000|Reported Event|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
11135493|NCT01786902|BG000|Baseline|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
11135494|NCT01786902|BG001|Baseline|Non-treatment Control Group|Height be measured with no treatment
11135495|NCT01786902|BG002|Baseline|Total|Total of all reporting groups
11135496|NCT01786902|FG000|Participant Flow|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
11135497|NCT01786902|FG001|Participant Flow|Non-treatment Control Group|Height be measured with no treatment
11135498|NCT01786902|OG000|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
11135499|NCT01786902|OG001|Outcome|Non-treatment Control Group|Height be measured with no treatment
11135500|NCT01786902|EG000|Reported Event|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
11135501|NCT01786902|EG001|Reported Event|Non-treatment Control Group|Height be measured with no treatment
11135502|NCT01786954|BG000|Baseline|Icare, Goldmann, Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.~Icare rebound tonometry~Tonopen applanation~Goldmann applanation"
11135503|NCT01786954|FG000|Participant Flow|Sequence 1: Icare Then Goldmann Then Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Goldmann applanation then Tonopen applanation.~Icare rebound tonometry~Goldmann applanation~Tonopen applanation"
11135504|NCT01786954|FG001|Participant Flow|Sequence 2: Icare Then Tonopen Then Goldmann|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Tonopen applanation then Goldmann applanation.~Icare rebound tonometry~Tonopen applanation~Goldmann applanation"
11135505|NCT01786954|OG000|Outcome|Icare|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.~Icare rebound tonometry"
11135506|NCT01786954|OG001|Outcome|Tonopen|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
11135507|NCT01786954|OG002|Outcome|Goldmann|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
11135508|NCT01786954|OG000|Outcome|Icare|
11135509|NCT01786954|OG001|Outcome|Tonopen|
11135510|NCT01786954|OG002|Outcome|Goldmann|
11135511|NCT01786954|EG000|Reported Event|Sequence 1: Icare, Goldmann, Tonopen|Sequence 1: Icare, then Goldmann, then Tonopen
11135512|NCT01786954|EG001|Reported Event|Sequence 2: Icare, Tonopen, Goldmann|Sequence 2: Icare, then Tonopen, then Goldmann
11135513|NCT01786967|BG000|Baseline|Fesoterodine Fumarate|Women aged 50 and older received 4mg of fesoterodine fumarate for 2 weeks followed by 8mg fesoterodine for 2 weeks.
11135514|NCT01786967|FG000|Participant Flow|Fesoterodine Fumarate|"Participants will receive 4 mg of study drug for first 2 weeks, and then 8 mg of study drugs for 2 weeks.~Fesoterodine Fumarate: FDA approved anticholinergic medication used for treatment of urge urinary incontinence"
11135515|NCT01786967|OG000|Outcome|Extensive Metabolizers|Extensive metabolizer status was based on CYP2D6 sequence
11135516|NCT01786967|OG001|Outcome|Poor Metabolizers|Poor metabolizer status was based on CYP2D6 sequence
11135517|NCT01786967|OG000|Outcome|Extensive Metabolizers|Extensive metabolizer status is based on CYP2D6 sequence
11135518|NCT01786967|OG001|Outcome|Poor Metabolizers|Poor metabolizer status is based on CYP2D6 sequence
11135519|NCT01786967|EG000|Reported Event|Extensive Metabolizers|Extensive metabolizer status was based on CYP2D6 sequence
11135520|NCT01786967|EG001|Reported Event|Poor Metabolizers|Poor metabolizer status was based on CYP2D6 sequence
11135521|NCT01786967|EG002|Reported Event|Metabolizer Status Undetermined|Metabolizer status was not able to be determined
11135522|NCT01786993|BG000|Baseline|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
11135523|NCT01786993|BG001|Baseline|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
11135524|NCT01786993|BG002|Baseline|Total|Total of all reporting groups
11135525|NCT01786993|FG000|Participant Flow|Multi-point Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
11135526|NCT01786993|FG001|Participant Flow|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
11135527|NCT01786993|OG000|Outcome|BiV/MPP Patients|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).
11135528|NCT01786993|OG000|Outcome|MultiPoint Pacing Arm|"MultiPoint Pacing~MultiPoint Pacing: Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study."
11135529|NCT01786993|OG001|Outcome|Biventricular Arm|"Traditional Biventricular Pacing~Traditional Biventricular Pacing: Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available."
11135530|NCT01786993|EG000|Reported Event|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
11135531|NCT01786993|EG001|Reported Event|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
11135532|NCT01787006|BG000|Baseline|Cetuximab, Cisplatin, 5-FU, Radiotherapy|"Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV~5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)~radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."
11135533|NCT01787006|BG001|Baseline|Cisplatin, 5-FU, Radiotherapy|"5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)~radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."
11135534|NCT01787006|BG002|Baseline|Total|Total of all reporting groups
11135535|NCT01787006|FG000|Participant Flow|Cetuximab, Cisplatin, 5-FU, Radiotherapy|"Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV~5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)~radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."
11135536|NCT01787006|FG001|Participant Flow|Cisplatin, 5-FU, Radiotherapy|"5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)~radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."
11135537|NCT01787006|OG000|Outcome|Cetuximab, Cisplatin, 5-FU, Radiotherapy|"Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV~5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)~radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."
11135538|NCT01787006|OG001|Outcome|Cisplatin, 5-FU, Radiotherapy|"5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)~radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."
11135539|NCT01787006|EG000|Reported Event|Cetuximab, Cisplatin, 5-FU, Radiotherapy|"Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV~5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)~radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."
11135540|NCT01787006|EG001|Reported Event|Cisplatin, 5-FU, Radiotherapy|"5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)~radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."
11135541|NCT01787032|BG000|Baseline|BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135542|NCT01787032|BG001|Baseline|BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135543|NCT01787032|BG002|Baseline|BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135544|NCT01787032|BG003|Baseline|BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135545|NCT01787032|BG004|Baseline|BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135546|NCT01787032|BG005|Baseline|BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135547|NCT01787032|BG006|Baseline|Total|Total of all reporting groups
11149662|NCT01872078|EG001|Reported Event|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
11149663|NCT01872078|EG002|Reported Event|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
11149664|NCT01872078|EG003|Reported Event|Placebo|Two matching placebo tablets for both the morning and evening doses
11135548|NCT01787032|FG000|Participant Flow|BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135549|NCT01787032|FG001|Participant Flow|BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135550|NCT01787032|FG002|Participant Flow|BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135551|NCT01787032|FG003|Participant Flow|BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135552|NCT01787032|FG004|Participant Flow|BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135553|NCT01787032|FG005|Participant Flow|BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
11135554|NCT01787032|OG000|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
11135555|NCT01787032|OG001|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
11135556|NCT01787032|OG002|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
11135557|NCT01787032|EG000|Reported Event|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
11135558|NCT01787032|EG001|Reported Event|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
11135559|NCT01787032|EG002|Reported Event|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
11135560|NCT01787032|EG003|Reported Event|Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours.
11135561|NCT01787032|EG004|Reported Event|Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours.
11135562|NCT01787097|BG000|Baseline|Symbicort®, Formoterol, Budesonide|"All Patients will receive randomly one-off dose of the following treatments:~Formoterol (FORM) total dose 24ug: is a LABA chosen at a higher clinical dose to determine whether this treatment can achieve an effective treatment response on GR in sputum cells compare to treatments 2 and 3.~Symbicort® total dose 400ug/12ug: is a combination of FORM (6ug) and ICS (Budesonide, (BUD) 200ug) at a lower-dose to determine whether this combination can have an effect on GR in sputum cells compare to treatment 4, 1 and 3.~Symbicort® total dose 800ug/24ug: is a combination FORM (12ug) and BUD (400ug) at a higher-dose, chosen to compare the effect on GR with treatment 4 and 1~BUD total dose 800ug: is an intermediate dose of ICS chosen for comparison with treatments 2 and 3 on GR.~Symbicort®, Formoterol, Budesonide: Formeterol is Long acting beta 2-agonist (LABA) whereas Budesonide is inhaled corticosteroids (ICS)."
11135563|NCT01787097|FG000|Participant Flow|Formoterol 24ug|The first intervention is Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug, then Symbicort® total dose 800ug/24ug, then BUD total dose 800ug
11135564|NCT01787097|FG001|Participant Flow|Symbicort® Total Dose 400ug/12ug|The first intervention is Symbicort® total dose 400ug/12ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 800ug/24ug, then BUD total dose 800ug
11135565|NCT01787097|FG002|Participant Flow|Symbicort® Total Dose 800ug/24ug|The first intervention is Symbicort® total dose 800ug/24ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug, then BUD total dose 800ug
11135566|NCT01787097|FG003|Participant Flow|BUD Total Dose 800ug|The first intervention is BUD total dose 800ug, then Symbicort® total dose 800ug/24ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug
11135567|NCT01787097|OG000|Outcome|Formoterol (FORM) Total Dose 24ug|Participants received Formoterol (FORM) total dose 24ug
11135568|NCT01787097|OG001|Outcome|Symbicort® Total Dose 400ug/12ug|Participants received 2 puffs of a combination of formoterol (6ug) and ICS (Budesonide, (BUD) 200ug)
11135569|NCT01787097|OG002|Outcome|Symbicort® Total Dose 800ug/24ug|Participants received 2 puffs of a combination of formoterol (12ug) and budesonide (400ug)
11135570|NCT01787097|OG003|Outcome|Pulmicort 800ug|Participants received 2 puffs of Budesoinde 400g (total dose 800ug)
11135571|NCT01787097|OG000|Outcome|Formoterol (FORM) Total Dose 24ug|2 puffs of Formoterol (FORM) 12ug (total dose 24ug)
11135572|NCT01787097|OG001|Outcome|Symbicort® Total Dose 400ug/12ug|2 puffs of a combination of formoterol (6ug) and ICS (Budesonide, (BUD) 200ug)
11135573|NCT01787097|OG002|Outcome|Symbicort® Total Dose 800ug/24ug|2 puffs of a combination of Formoterol (12ug) and budesonide (400ug)
11135574|NCT01787097|OG003|Outcome|Pulmicort 800|2 puffs of budesonide 400ug (total dose 800ug)
11135575|NCT01787097|OG001|Outcome|Symbicort® Total Dose 400ug/12ug|2 puffs of a combination of Formoterol (6ug) and ICS (Budesonide, (BUD) 200ug)
11135576|NCT01787097|OG003|Outcome|Pulmicort 800|budesonide total dose 800ug
11135577|NCT01787097|OG002|Outcome|Symbicort® Total Dose 800ug/24ug|2 puffs of a combination of formoterol (12ug) and BUD (400ug)
11135578|NCT01787097|OG003|Outcome|Pulmicort 800ug|budesonide total dose 800ug
11135579|NCT01787097|OG002|Outcome|Symbicort® Total Dose 800ug/24ug:|2 puffs of a combination of formoterol (12ug) and BUD (400ug)
11135580|NCT01787097|OG003|Outcome|Pulmicort 800ug|Budesonide total dose 800ug
11135581|NCT01787097|EG000|Reported Event|Formoterol 24ug|Formoterol (FORM) total dose 24ug:
11135582|NCT01787097|EG001|Reported Event|Symbicort® Total Dose 400ug/12ug:|Symbicort® total dose 400ug/12ug: 2 puffs of combination formoterol (12ug) and BUD (200ug)
11135583|NCT01787097|EG002|Reported Event|Symbicort® Total Dose 800ug/24ug|Symbicort® total dose 800ug/24ug: 2 puffs of a combination of formoterol (12ug) and BUD (400ug)
11135584|NCT01787097|EG003|Reported Event|Pulmicort 800ug|budesonide total dose 800ug:
11135585|NCT01787175|BG000|Baseline|Integration Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
11135586|NCT01787175|BG001|Baseline|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
11135587|NCT01787175|BG002|Baseline|Total|Total of all reporting groups
11135588|NCT01787175|FG000|Participant Flow|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
11135589|NCT01787175|FG001|Participant Flow|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
11135590|NCT01787175|OG000|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
11135591|NCT01787175|OG001|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
11135592|NCT01787175|EG000|Reported Event|Integrated Medication Manager|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.~Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
11135593|NCT01787175|EG001|Reported Event|Standard EHR|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.~Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
11135594|NCT01787188|BG000|Baseline|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
11135595|NCT01787188|BG001|Baseline|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
11135596|NCT01787188|BG002|Baseline|Placebo|Placebo: Capsule
11135597|NCT01787188|BG003|Baseline|Total|Total of all reporting groups
11135598|NCT01787188|FG000|Participant Flow|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
11135599|NCT01787188|FG001|Participant Flow|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
11135600|NCT01787188|FG002|Participant Flow|Placebo|Placebo: Capsule
11135601|NCT01787188|OG000|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
11135602|NCT01787188|OG001|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
11135603|NCT01787188|OG002|Outcome|Placebo|Placebo: Capsule
11135604|NCT01787188|EG000|Reported Event|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
11135605|NCT01787188|EG001|Reported Event|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
11135606|NCT01787188|EG002|Reported Event|Placebo|Placebo: Capsule
11135607|NCT01787240|BG000|Baseline|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
11135608|NCT01787240|BG001|Baseline|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
11135609|NCT01787240|BG002|Baseline|Total|Total of all reporting groups
11135610|NCT01787240|FG000|Participant Flow|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
11135611|NCT01787240|FG001|Participant Flow|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
11135612|NCT01787240|OG000|Outcome|Eligible Patients|Number of patients who were screened and were determined to be eligible for the study.
11135613|NCT01787240|OG000|Outcome|Phase 2 Placebo|Participants assigned to take placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
11135614|NCT01787240|OG001|Outcome|Phase 2 Active|Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
11135615|NCT01787240|OG000|Outcome|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
11135616|NCT01787240|OG001|Outcome|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
11135617|NCT01787240|EG000|Reported Event|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
11135618|NCT01787240|EG001|Reported Event|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
11135619|NCT01787279|BG000|Baseline|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
11135620|NCT01787279|FG000|Participant Flow|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered peg interferon alpha-2a (PEGASYS), 40 kilodalton (kD), 180 micrograms (mcg), subcutaneously, once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
11135621|NCT01787279|OG000|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
11135622|NCT01787279|EG000|Reported Event|Peginterferon Alpha-2a, 180 mcg/ 48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
11135623|NCT01787292|BG000|Baseline|Exercise Interventions for Crossover Design|This study was a cross-over design with two groups to which participants were randomized. Group one received a 12-week Aerobic exercise intervention and then crossed over into a balance exercise intervention. Group two received the balance intervention for 12 weeks and then crossed over into the aerobic exercise intervention. All completing participants then engaged in a home based exercise program during which they were instructed to exercise thrice weekly over 24 weeks.
11135624|NCT01787292|FG000|Participant Flow|Experimental: Aerobic Exercise, Then Balance Training|Participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session. After two to four week washout period, participants entered a second 12-week intervention involving light stretching and balance exercise under a supervised trainer three times per week for 20-45 minutes per session.
11135625|NCT01787292|FG001|Participant Flow|Experimental: Balance Training, Then Aerobic Exercise|Participants completed a 12-week light stretching and balance exercise program under a supervised trainer three times per week for 20-45 minutes per session.Participants completed an interval aerobic cycling under supervised trainer three times per week for 20-45 minutes per session. After two to four week washout period, participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session.
11135626|NCT01787292|OG000|Outcome|Experimental: Aerobic First|Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
10887372|NCT00500240|OG000|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin
11135627|NCT01787292|OG000|Outcome|Balance Training|Effects of Balance/Stretching training after 12-week intervention
11135628|NCT01787292|OG000|Outcome|Exercise - Cycling|Short Term exercise - supervised: Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
11135629|NCT01787292|OG000|Outcome|Aerobic First Then Balance Cross-over|Aerobic cycling first then cross-over to balance group
11135630|NCT01787292|OG000|Outcome|Exercise Interventions for Crossover Design|This study was a cross-over design with two groups to which participants were randomized. Group one received a 12-week Aerobic exercise intervention and then crossed over into a balance exercise intervention. Group two received the balance intervention for 12 weeks and then crossed over into the aerobic exercise intervention. All completing participants then engaged in a home based exercise program during which they were instructed to exercise thrice weekly over 24 weeks.
11135631|NCT01787292|OG000|Outcome|Balance Training|Effects of Balance/Stretching training after study completion
11135632|NCT01787292|OG000|Outcome|Aerobic Exercise|Participants in this group first received a 12-week Aerobic exercise intervention and then crossed over into a balance exercise intervention.
11135633|NCT01787292|EG000|Reported Event|Experimental Intervention: Aerobic Exercise First|"Participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session. After two to four week washout period, participants entered a second 12-week intervention involving light stretching and balance exercise under a supervised trainer three times per week for 20-45 minutes per session.~Participants later crossed over into the Balance condition and were assessed at 24 weeks.~After this time, participants completed a 24 week home based aerobic exercise program. This intervention was common to both groups and therefore are collapsed within this Arm."
11135634|NCT01787292|EG001|Reported Event|Experimental Intervention: Balance Exercise First|"Participants completed a 12-week light stretching and balance exercise program under a supervised trainer three times per week for 20-45 minutes per session.Participants completed an interval aerobic cycling under supervised trainer three times per week for 20-45 minutes per session. After two to four week washout period, participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session.~Participants later crossed over into the Aerobic Exercise condition and were assessed at 24 weeks.~After this time, participants completed a 24 week home based aerobic exercise program. This intervention was common to both groups and therefore are collapsed within this Arm."
11135635|NCT01787331|BG000|Baseline|Treatment (Itraconazole)|Patients receive twice/day 300mg itraconazole (oral)
11135636|NCT01787331|FG000|Participant Flow|Treatment (Itraconazole)|Patients receive twice/day 300mg itraconazole (oral)
11135637|NCT01787331|OG000|Outcome|Treatment (Itraconazole)|Patients receive twice/day 300mg itraconazole (oral)
11135638|NCT01787331|EG000|Reported Event|Treatment (Itraconazole)|Patients receive twice/day 300mg itraconazole (oral)
11135639|NCT01787383|BG000|Baseline|Ingenol Mebutate Gel Simultaneous Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied simultaneously~Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied simultaneously"
11135640|NCT01787383|BG001|Baseline|Ingenol Mebutate Gel Sequential Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied sequentially~Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied sequentially"
11135641|NCT01787383|BG002|Baseline|Total|Total of all reporting groups
11135642|NCT01787383|FG000|Participant Flow|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
11135643|NCT01787383|FG001|Participant Flow|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
11135644|NCT01787383|OG000|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
11135645|NCT01787383|OG001|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
11135646|NCT01787383|OG000|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
11135647|NCT01787383|OG001|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
11135648|NCT01787383|OG000|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side EffectsTSQM compliance was lower than the number of randomised subjects.
10887373|NCT00500240|OG001|Outcome|Intervention Group|Intense blood sugar management with Insulin Aspart + Insulin Glargine
11135649|NCT01787383|OG001|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side Effects TSQM compliance was lower than the number of randomised subjects.
11135650|NCT01787383|OG000|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
11135651|NCT01787383|OG001|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
11135652|NCT01787383|OG000|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
11135653|NCT01787383|OG001|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
11135654|NCT01787383|EG000|Reported Event|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
11135655|NCT01787383|EG001|Reported Event|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
11135656|NCT01787461|BG000|Baseline|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
11135657|NCT01787461|BG001|Baseline|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
11135658|NCT01787461|BG002|Baseline|Total|Total of all reporting groups
11135659|NCT01787461|FG000|Participant Flow|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
11135660|NCT01787461|FG001|Participant Flow|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
11135661|NCT01787461|OG000|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
11135662|NCT01787461|OG001|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
11135663|NCT01787461|EG000|Reported Event|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
11135664|NCT01787461|EG001|Reported Event|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
11135665|NCT01787591|BG000|Baseline|Healthy Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
11135666|NCT01787591|BG001|Baseline|Metabolic Syndrome Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
11135667|NCT01787591|BG002|Baseline|Total|Total of all reporting groups
11135668|NCT01787591|FG000|Participant Flow|Acute Fat-Free Milk Ingestion First|"Participants ingested fat-free milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and soy milk.~Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135669|NCT01787591|FG001|Participant Flow|Acute Low-Fat Milk Ingestion First|"Participants ingested low-free milk first and then the remaining three milks in a randomized order: fat-fat milk, full-fat milk, and soy milk.~Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135670|NCT01787591|FG002|Participant Flow|Acute Full-Fat Milk Ingestion First|"Participants ingested full-free milk first and then the remaining three milks in a randomized order: low-fat milk, low-fat milk, and soy milk.~Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135671|NCT01787591|FG003|Participant Flow|Acute Soy Milk Ingestion First|"Participants ingested soy milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and fat-free milk.~Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.~Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135672|NCT01787591|OG000|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135673|NCT01787591|OG001|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135674|NCT01787591|OG002|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135675|NCT01787591|OG003|Outcome|Acute Soy Milk Ingestion|Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
11135676|NCT01787591|OG003|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
11135677|NCT01787591|EG000|Reported Event|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135678|NCT01787591|EG001|Reported Event|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135679|NCT01787591|EG002|Reported Event|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135680|NCT01787591|EG003|Reported Event|Acute Soy Milk Ingestion|"Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.~Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
11135681|NCT01787604|BG000|Baseline|Aortic Root Reimplantation Procedure|"Aortic Root Reimplantation Procedure~Aortic Root Reimplantation Procedure: Modified Florida Sleeve."
11135682|NCT01787604|BG001|Baseline|Aortic Valve Reimplantation Procedure|"Aortic Valve Reimplantation Procedure~Aortic Valve Reimplantation Procedure: David I"
11135683|NCT01787604|BG002|Baseline|Total|Total of all reporting groups
11135684|NCT01787604|FG000|Participant Flow|Aortic Root Reimplantation Procedure|"Aortic Root Reimplantation Procedure~Aortic Root Reimplantation Procedure: Modified Florida Sleeve."
11135685|NCT01787604|FG001|Participant Flow|Aortic Valve Reimplantation Procedure|"Aortic Valve Reimplantation Procedure~Aortic Valve Reimplantation Procedure: David I"
11135686|NCT01787604|OG000|Outcome|Aortic Root Reimplantation Procedure|"Aortic Root Reimplantation Procedure~Aortic Root Reimplantation Procedure: Modified Florida Sleeve."
11135687|NCT01787604|OG001|Outcome|Aortic Valve Reimplantation Procedure|"Aortic Valve Reimplantation Procedure~Aortic Valve Reimplantation Procedure: David I"
11135688|NCT01787604|EG000|Reported Event|Aortic Root Reimplantation Procedure|"Aortic Root Reimplantation Procedure~Aortic Root Reimplantation Procedure: Modified Florida Sleeve."
11135689|NCT01787604|EG001|Reported Event|Aortic Valve Reimplantation Procedure|"Aortic Valve Reimplantation Procedure~Aortic Valve Reimplantation Procedure: David I"
11135690|NCT01787760|BG000|Baseline|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
11135691|NCT01787760|BG001|Baseline|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
11135692|NCT01787760|BG002|Baseline|Spectacle Lenses|Control spectacle lenses worn daily.
11135693|NCT01787760|BG003|Baseline|Total|Total of all reporting groups
11135694|NCT01787760|FG000|Participant Flow|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
11135695|NCT01787760|FG001|Participant Flow|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
11135696|NCT01787760|FG002|Participant Flow|Spectacle Lenses|Control spectacle lenses worn daily.
11135697|NCT01787760|OG000|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
11135698|NCT01787760|OG001|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
11135699|NCT01787760|OG002|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
11135700|NCT01787760|EG000|Reported Event|Spectacle Lenses|Control spectacle lenses worn daily.
11135701|NCT01787760|EG001|Reported Event|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
11135702|NCT01787760|EG002|Reported Event|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
11135703|NCT01787760|EG003|Reported Event|Not Randomized|Subjects who met the all study eligible criteria but did not randomize to the study arm.
11135704|NCT01787799|BG000|Baseline|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
11135705|NCT01787799|FG000|Participant Flow|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
11135706|NCT01787799|OG000|Outcome|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
11135707|NCT01787799|EG000|Reported Event|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
11135708|NCT01787825|BG000|Baseline|All Study Participants|"PillCam SB2 capsule and CapsoCam SV-1 capsule in random order, PillCam SB2 capsule: Capsule Endoscopy system, CapsoCam SV-1: Capsule endoscopy~The analysis population consisted of subjects that swallowed the capsules."
11135709|NCT01787825|FG000|Participant Flow|CapsoCam SV-1 Then PillCam SB2|Participants first received CapsoCam SV-1 then 30-60 minutes later received Pillcam SB2
11135710|NCT01787825|FG001|Participant Flow|PillCam SB2 Then CapsoCam SV-1|Participants first received PillCam SB2 then 30-60 minutes later receive CapsoCam SV-1
11135711|NCT01787825|OG000|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
11135712|NCT01787825|OG001|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
11135713|NCT01787825|OG000|Outcome|CapsoCam SV-1 Preference|Subject preference for CapsoCam SV-1
11135714|NCT01787825|OG001|Outcome|PillCam SB2|Subject preference for PillCam SB2
11135715|NCT01787825|EG000|Reported Event|All Study Participants|PillCam SB Capsule and CapsoCam SV-1
11135716|NCT01787838|BG000|Baseline|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
11135717|NCT01787838|FG000|Participant Flow|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
11135718|NCT01787838|OG000|Outcome|Health Education, Audit and Feedback|"Prospective single group intervention Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about immunizations."
11135719|NCT01787838|EG000|Reported Event|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
11135720|NCT01787916|BG000|Baseline|All Study Participants|Patients beginning with liraglutide will be switched to Placebo and vice versa
11135721|NCT01787916|FG000|Participant Flow|Liraglutide First, Then Placebo|"Liraglutide, s.c., 1.8 mg, die, 24 weeks~First Intervention (24 weeks), Washout (4 weeks), and Second Intervention (24 weeks"
11135722|NCT01787916|FG001|Participant Flow|Placebo First, the Liraglutide|subjects were submitted to placebo and liraglutide in a randomly manner
11135723|NCT01787916|OG000|Outcome|Liraglutide|"Liraglutide, s.c., 1.8 mg, die, 24 weeks~Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design"
11135724|NCT01787916|OG001|Outcome|Placebo|"Placebo visually identical to study drug will be given~Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design"
11135725|NCT01787916|EG000|Reported Event|Liraglutide|"Liraglutide, s.c., 1.8 mg, die, 24 weeks~Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design"
11135726|NCT01787916|EG001|Reported Event|Placebo|"Placebo visually identical to study drug will be given~Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design"
11135727|NCT01788046|BG000|Baseline|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
11135728|NCT01788046|BG001|Baseline|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
11135729|NCT01788046|BG002|Baseline|Total|Total of all reporting groups
11135730|NCT01788046|FG000|Participant Flow|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
11135731|NCT01788046|FG001|Participant Flow|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
11135732|NCT01788046|OG000|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
11135733|NCT01788046|OG001|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
11135734|NCT01788046|EG000|Reported Event|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
11135735|NCT01788046|EG001|Reported Event|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
11135736|NCT01788150|BG000|Baseline|Svelte Drug-Eluting Coronary Stent|"Coronary Stenting~Coronary Stenting"
11135737|NCT01788150|BG001|Baseline|Medtronic Resolute Integrity Drug-Eluting Stent|"Coronary Stenting~Coronary Stenting"
11135738|NCT01788150|BG002|Baseline|Total|Total of all reporting groups
11135739|NCT01788150|FG000|Participant Flow|Svelte Drug-Eluting Coronary Stent|"Coronary Stenting~Coronary Stenting"
11135740|NCT01788150|FG001|Participant Flow|Medtronic Resolute Integrity Drug-Eluting Stent|"Coronary Stenting~Coronary Stenting"
11135741|NCT01788150|OG000|Outcome|Svelte Drug-Eluting Coronary Stent|"Coronary Stenting~Coronary Stenting"
11135742|NCT01788150|OG001|Outcome|Medtronic Resolute Integrity Drug-Eluting Stent|"Coronary Stenting~Coronary Stenting"
11135743|NCT01788150|EG000|Reported Event|Svelte Drug-Eluting Coronary Stent|"Coronary Stenting~Coronary Stenting"
11135744|NCT01788150|EG001|Reported Event|Medtronic Resolute Integrity Drug-Eluting Stent|"Coronary Stenting~Coronary Stenting"
11135745|NCT01788163|BG000|Baseline|China|Subjects in China that meet I/E and population criteria.
11135746|NCT01788163|BG001|Baseline|Taiwan|Subjects in Taiwan that meet I/E and population criteria
11135747|NCT01788163|BG002|Baseline|South Korea|Subjects in South Korea that meet I/E and population criteria
11135748|NCT01788163|BG003|Baseline|Australia|Subjects in Australia that meet I/E and population criteria
11135749|NCT01788163|BG004|Baseline|Thailand|Subjects in Thailand that meet I/E and population criteria
11135750|NCT01788163|BG005|Baseline|Singapore|Subjects in Singapore that meet I/E and population criteria
11135751|NCT01788163|BG006|Baseline|Malaysia|Subjects in Malaysia that meet I/E and population criteria
11135752|NCT01788163|BG007|Baseline|Indonesia|Subjects in Indonesia that meet I/E and population criteria
11135753|NCT01788163|BG008|Baseline|Russia|Subjects in Russia that meet I/E and population criteria
11135754|NCT01788163|BG009|Baseline|Total|Total of all reporting groups
11135755|NCT01788163|FG000|Participant Flow|China|Subjects in China that meet Inclusion/Exclusion (I/E) and population criteria.
11135756|NCT01788163|FG001|Participant Flow|Taiwan|Subjects in Taiwan that meet I/E and population criteria
11135757|NCT01788163|FG002|Participant Flow|South Korea|Subjects in South Korea that meet I/E and population criteria
11135758|NCT01788163|FG003|Participant Flow|Australia|Subjects in Australia that meet I/E and population criteria
11135759|NCT01788163|FG004|Participant Flow|Thailand|Subjects in Thailand that meet I/E and population criteria
11135760|NCT01788163|FG005|Participant Flow|Singapore|Subjects in Singapore that meet I/E and population criteria
11135761|NCT01788163|FG006|Participant Flow|Malaysia|Subjects in Malaysia that meet I/E and population criteria
11135762|NCT01788163|FG007|Participant Flow|Indonesia|Subjects in Indonesia that meet I/E and population criteria
11135763|NCT01788163|FG008|Participant Flow|Russia|Subjects in Russia that meet I/E and population criteria
11135764|NCT01788163|OG000|Outcome|China|Subjects in China that meet I/E and population criteria.
11135765|NCT01788163|OG001|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
11135766|NCT01788163|OG002|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
11135767|NCT01788163|OG003|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
11135768|NCT01788163|OG004|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
11135769|NCT01788163|OG005|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
11135770|NCT01788163|OG006|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
11135771|NCT01788163|OG007|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
11135772|NCT01788163|OG008|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
11135773|NCT01788163|OG000|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135774|NCT01788163|OG001|Outcome|China-Non-adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135775|NCT01788163|OG002|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135776|NCT01788163|OG003|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135777|NCT01788163|OG004|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135778|NCT01788163|OG005|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135779|NCT01788163|OG006|Outcome|Australia-Adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135780|NCT01788163|OG007|Outcome|Australia-Non-adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135781|NCT01788163|OG008|Outcome|Thailand-Adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135782|NCT01788163|OG009|Outcome|Thailand-Non-adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135783|NCT01788163|OG010|Outcome|Singapore-Adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135784|NCT01788163|OG011|Outcome|Singapore-Non-adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135785|NCT01788163|OG012|Outcome|Malaysia-Adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135786|NCT01788163|OG013|Outcome|Malaysia-Non-adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135787|NCT01788163|OG014|Outcome|Indonesia-Adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135788|NCT01788163|OG015|Outcome|Indonesia-Non-adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135789|NCT01788163|OG016|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135790|NCT01788163|OG017|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135791|NCT01788163|OG003|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
11135792|NCT01788163|OG001|Outcome|China-Non-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135793|NCT01788163|OG006|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
11135794|NCT01788163|OG007|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
11135795|NCT01788163|OG000|Outcome|China - Sensitivity|Subjects in China that meet I/E and population criteria, who had a sensitivity test performed.
11135796|NCT01788163|OG001|Outcome|China - Specificty|Subjects in China that meet I/E and population criteria, who had a specificity test performed.
11135797|NCT01788163|OG002|Outcome|Taiwan - Sensitivity|Subjects in Taiwan that meet I/E and population criteria, who had a sensitivity test performed.
11135798|NCT01788163|OG003|Outcome|Taiwan - Specificity|Subjects in Taiwan that meet I/E and population criteria, who had a specificity test performed.
11135799|NCT01788163|OG004|Outcome|South Korea - Sensitivity|Subjects in South Korea that meet I/E and population criteria, who had a sensitivity test performed.
11135800|NCT01788163|OG005|Outcome|South Korea - Specificity|Subjects in South Korea that meet I/E and population criteria, who had a specificity test performed.
11135801|NCT01788163|OG006|Outcome|Russia - Sensitivity|Subjects in Russia that meet I/E and population criteria, who had a sensitivity test performed.
11135802|NCT01788163|OG007|Outcome|Russia - Specificity|Subjects in Russia that meet I/E and population criteria, who had a specificity test performed.
11135803|NCT01788163|OG000|Outcome|China - Positive Predictive Value|Subjects in China that meet I/E and population criteria, who had a Positive Predictive test performed.
11135804|NCT01788163|OG001|Outcome|China - Negative Predictive Value|Subjects in China that meet I/E and population criteria, who had a Negative Predictive test performed.
11135805|NCT01788163|OG002|Outcome|Taiwan - Positive Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Predictive test performed.
11135806|NCT01788163|OG003|Outcome|Taiwan - Negative Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Predictive test performed.
11135807|NCT01788163|OG004|Outcome|South Korea - Positive Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Positive Predictive test performed.
11135808|NCT01788163|OG005|Outcome|South Korea - Negative Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Negative Predictive test performed.
11135809|NCT01788163|OG006|Outcome|Russia - Positive Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Positive Predictive test performed.
11135810|NCT01788163|OG007|Outcome|Russia - Negative Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Negative Predictive test performed.
11135811|NCT01788163|OG000|Outcome|China|Subjects in China that meet I/E and population criteria
11135812|NCT01788163|OG000|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
11135813|NCT01788163|OG001|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
11135814|NCT01788163|OG000|Outcome|China-Mutation Status Positive|Subjects in China that meet I/E and population criteria, who had a Positive Mutation Status.
11135815|NCT01788163|OG001|Outcome|China-Mutation Status Negative|Subjects in China that meet I/E and population criteria, who had a Negative Mutation Status.
11135816|NCT01788163|OG002|Outcome|Taiwan-Mutation Status Positive|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Mutation Status.
11135817|NCT01788163|OG003|Outcome|Taiwan-Mutation Status Negative|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Mutation Status.
11135818|NCT01788163|OG004|Outcome|South Korea-Mutation Status Positive|Subjects in South Korea that meet I/E and population criteria, who had a Positive Mutation Status.
11135819|NCT01788163|OG005|Outcome|South Korea-Mutation Status Negative|Subjects in South Korea that meet I/E and population criteria, who had a Negative Mutation Status.
11135820|NCT01788163|OG006|Outcome|Australia-Mutation Status Positive|Subjects in Australia that meet I/E and population criteria, who had a Positive Mutation Status.
11135821|NCT01788163|OG007|Outcome|Australia-Mutation Status Negative|Subjects in Australia that meet I/E and population criteria, who had a Negative Mutation Status.
11135822|NCT01788163|OG008|Outcome|Thailand-Mutation Status Positive|Subjects in Thailand that meet I/E and population criteria, who had a Positive Mutation Status.
11135823|NCT01788163|OG009|Outcome|Thailand-Mutation Status Negative|Subjects in Thailand that meet I/E and population criteria, who had a Negative Mutation Status.
11135824|NCT01788163|OG010|Outcome|Singapore-Mutation Status Positive|Subjects in Singapore that meet I/E and population criteria, who had a Positive Mutation Status.
11135825|NCT01788163|OG011|Outcome|Singapore-Mutation Status Negative|Subjects in Singapore that meet I/E and population criteria, who had a Negative Mutation Status.
11135826|NCT01788163|OG012|Outcome|Malaysia-Mutation Status Positive|Subjects in Malaysia that meet I/E and population criteria, who had a Positive Mutation Status.
11135827|NCT01788163|OG013|Outcome|Malaysia-Mutation Status Negative|Subjects in Malaysia that meet I/E and population criteria, who had a Negative Mutation Status.
11135828|NCT01788163|OG014|Outcome|Indonesia-Mutation Status Positive|Subjects in Indonesia that meet I/E and population criteria, who had a Positive Mutation Status.
11135829|NCT01788163|OG015|Outcome|Indonesia-Mutation Status Negative|Subjects in Indonesia that meet I/E and population criteria, who had a Negative Mutation Status.
11135830|NCT01788163|OG016|Outcome|Russia-Mutation Status Positive|Subjects in Russia that meet I/E and population criteria, who had a Positive Mutation Status.
11135831|NCT01788163|OG017|Outcome|Russia-Mutation Status Negative|Subjects in Russia that meet I/E and population criteria, who had a Negative Mutation Status.
11135832|NCT01788163|EG000|Reported Event|China|Subjects in China that meet I/E and population criteria.
11135833|NCT01788163|EG001|Reported Event|Taiwan|Subjects in Taiwan that meet I/E and population criteria
11135834|NCT01788163|EG002|Reported Event|South Korea|Subjects in South Korea that meet I/E and population criteria
11135835|NCT01788163|EG003|Reported Event|Australia|Subjects in Australia that meet I/E and population criteria
11135836|NCT01788163|EG004|Reported Event|Thailand|Subjects in Thailand that meet I/E and population criteria
11135837|NCT01788163|EG005|Reported Event|Singapore|Subjects in Singapore that meet I/E and population criteria
11135838|NCT01788163|EG006|Reported Event|Malaysia|Subjects in Malaysia that meet I/E and population criteria
11135839|NCT01788163|EG007|Reported Event|Indonesia|Subjects in Indonesia that meet I/E and population criteria
11135840|NCT01788163|EG008|Reported Event|Russia|Subjects in Russia that meet I/E and population criteria
11135841|NCT01788215|BG000|Baseline|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
11135842|NCT01788215|BG001|Baseline|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
11135843|NCT01788215|BG002|Baseline|Total|Total of all reporting groups
11135844|NCT01788215|FG000|Participant Flow|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
11135845|NCT01788215|FG001|Participant Flow|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
11135846|NCT01788215|OG000|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
11135847|NCT01788215|OG001|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
11135848|NCT01788215|EG000|Reported Event|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
11135849|NCT01788215|EG001|Reported Event|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
11135850|NCT01788228|BG000|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135851|NCT01788228|BG001|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135852|NCT01788228|BG002|Baseline|Total|Total of all reporting groups
11135853|NCT01788228|FG000|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135854|NCT01788228|FG001|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135855|NCT01788228|OG000|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135856|NCT01788228|OG001|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135857|NCT01788228|OG002|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
11135858|NCT01788228|OG000|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant arm at Day 0 and dominant arm at Day 21.
11135859|NCT01788228|OG000|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135860|NCT01788228|EG000|Reported Event|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135861|NCT01788228|EG001|Reported Event|Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group|Subjects ˃64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
11135862|NCT01788358|BG000|Baseline|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
11135863|NCT01788358|FG000|Participant Flow|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
11135864|NCT01788358|OG000|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
11135865|NCT01788358|EG000|Reported Event|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
11135866|NCT01788423|BG000|Baseline|Audiologist-Based|"Audiologist selects hearing aid for patient~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135867|NCT01788423|BG001|Baseline|Consumer Decides|"Consumer selects hearing aid~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135868|NCT01788423|BG002|Baseline|Placebo|"Patient fitted with hearing aid that is acoustically transparent.~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135869|NCT01788423|BG003|Baseline|Total|Total of all reporting groups
11135870|NCT01788423|FG000|Participant Flow|Audiologist-Based|"Audiologist selects hearing aid for patient~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135871|NCT01788423|FG001|Participant Flow|Consumer Decides|"Consumer selects hearing aid~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135872|NCT01788423|FG002|Participant Flow|Placebo|"Patient fitted with hearing aid that is acoustically transparent.~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135873|NCT01788423|OG000|Outcome|Audiologist-Based|"Audiologist selects hearing aid for patient~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135874|NCT01788423|OG001|Outcome|Consumer Decides|"Consumer selects hearing aid~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135875|NCT01788423|OG002|Outcome|Placebo|"Patient fitted with hearing aid that is acoustically transparent.~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135876|NCT01788423|EG000|Reported Event|Audiologist-Based|"Audiologist selects hearing aid for patient~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135877|NCT01788423|EG001|Reported Event|Consumer Decides|"Consumer selects hearing aid~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135878|NCT01788423|EG002|Reported Event|Placebo|"Patient fitted with hearing aid that is acoustically transparent.~hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices."
11135879|NCT01788566|BG000|Baseline|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
11135880|NCT01788566|FG000|Participant Flow|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
11135881|NCT01788566|OG000|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
11135882|NCT01788566|EG000|Reported Event|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
11135883|NCT01788631|BG000|Baseline|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
11135884|NCT01788631|BG001|Baseline|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
11135885|NCT01788631|BG002|Baseline|Total|Total of all reporting groups
11135886|NCT01788631|FG000|Participant Flow|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
11135887|NCT01788631|FG001|Participant Flow|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
11135888|NCT01788631|OG000|Outcome|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
11135889|NCT01788631|OG001|Outcome|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
11135890|NCT01788631|EG000|Reported Event|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
11135891|NCT01788631|EG001|Reported Event|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
11135892|NCT01788943|BG000|Baseline|Normal Nicotine Metabolizers|Nicotine Metabolite Radio of > or = 0.26
11135893|NCT01788943|BG001|Baseline|Slow Nicotine Metabolizers|Nicotine Metabolite Radio of < 0.26.
11135894|NCT01788943|BG002|Baseline|Total|Total of all reporting groups
11135895|NCT01788943|FG000|Participant Flow|Slow Metabolizers.|Participants with an NMR < 0.26 will be considered slow metabolizers.
11135896|NCT01788943|FG001|Participant Flow|Normal Metabolizers|Participants with an NMR >= 0.26 will be considered normal metabolizers.
11135897|NCT01788943|OG000|Outcome|Slow Metabolizers.|Subjects with an NMR < 0.26.
11135898|NCT01788943|OG001|Outcome|Normal Metabolizers|Subjects with an NMR of > or = 0.26.
11135899|NCT01788943|EG000|Reported Event|Slow Metabolizers (NMR < 0.26)|No serious adverse events were observed.
11135900|NCT01788943|EG001|Reported Event|Normal Metabolizers (NMR > or + 0.26)|No serious adverse events were observed.
11135901|NCT01789047|BG000|Baseline|Topiramate|"Topiramate as adjunct to amantadine.~Topiramate: Topiramate as adjunct to amantadine"
11135902|NCT01789047|BG001|Baseline|Placebo (Sugar Pill)|"Placebo~Placebo: Placebo control"
11135903|NCT01789047|BG002|Baseline|Total|Total of all reporting groups
11135904|NCT01789047|FG000|Participant Flow|Topiramate|"Topiramate as adjunct to amantadine.~Topiramate: Topiramate as adjunct to amantadine"
11135905|NCT01789047|FG001|Participant Flow|Placebo (Sugar Pill)|"Placebo~Placebo: Placebo control"
11135906|NCT01789047|OG000|Outcome|Topiramate|"Topiramate as adjunct to amantadine.~Topiramate: Topiramate as adjunct to amantadine"
11135907|NCT01789047|OG001|Outcome|Placebo (Sugar Pill)|"Placebo~Placebo: Placebo control"
11135908|NCT01789047|EG000|Reported Event|Topiramate|"Topiramate as adjunct to amantadine.~Topiramate: Topiramate as adjunct to amantadine"
11135909|NCT01789047|EG001|Reported Event|Placebo (Sugar Pill)|"Placebo~Placebo: Placebo control"
11135910|NCT01789138|BG000|Baseline|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
11135911|NCT01789138|BG001|Baseline|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
11135912|NCT01789138|BG002|Baseline|Total|Total of all reporting groups
11135913|NCT01789138|FG000|Participant Flow|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
11135914|NCT01789138|FG001|Participant Flow|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
11135915|NCT01789138|OG000|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
11135916|NCT01789138|OG001|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
11135917|NCT01789138|EG000|Reported Event|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
11135918|NCT01789138|EG001|Reported Event|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
11135919|NCT01789203|BG000|Baseline|Ciprofloxacin|"Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant~Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator."
11135920|NCT01789203|BG001|Baseline|Placebo|"Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant~placebo"
11135921|NCT01789203|BG002|Baseline|Total|Total of all reporting groups
11135922|NCT01789203|FG000|Participant Flow|Ciprofloxacin|"Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant~Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator."
11135923|NCT01789203|FG001|Participant Flow|Placebo|"Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant~placebo"
11135924|NCT01789203|OG000|Outcome|Ciprofloxacin|"Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant~Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator."
11135925|NCT01789203|OG001|Outcome|Placebo|"Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant~placebo"
11135926|NCT01789203|OG000|Outcome|Ciprofloxacin|"Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant~Ciprofloxacin: Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator."
11135927|NCT01789203|OG001|Outcome|Placebo|"Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant~placebo: Patients will be randomized 2:1 placebo comparator to active comparator, Cipro."
11135928|NCT01789203|EG000|Reported Event|Ciprofloxacin|"Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant~Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator."
11135929|NCT01789203|EG001|Reported Event|Placebo|"Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant~placebo"
11135930|NCT01789255|BG000|Baseline|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
11135931|NCT01789255|FG000|Participant Flow|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
11135932|NCT01789255|OG000|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
11135933|NCT01789255|EG000|Reported Event|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
11135934|NCT01789281|BG000|Baseline|Everolimus|Participants who were receiving everolimus in a Novartis-sponsored study
11135935|NCT01789281|BG001|Baseline|Everolimus+Sandostatin LAR|Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study
11135936|NCT01789281|BG002|Baseline|Total|Total of all reporting groups
11135937|NCT01789281|FG000|Participant Flow|Everolimus|Participants who were receiving everolimus in a Novartis-sponsored study
11135938|NCT01789281|FG001|Participant Flow|Everolimus+Sandostatin LAR|Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study
11135939|NCT01789281|OG000|Outcome|Everolimus|Participants who were receiving everolimus in a Novartis-sponsored study
11135940|NCT01789281|OG001|Outcome|Everolimus+Sandostatin LAR|Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study
11135941|NCT01789281|EG000|Reported Event|Everolimus|Participants who were receiving everolimus in a Novartis-sponsored study
11135942|NCT01789281|EG001|Reported Event|Everolimus + Sandostatin LAR|Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study
11135943|NCT01789281|EG002|Reported Event|All Subjects|All subjects
11135944|NCT01789320|BG000|Baseline|Triamcinolone Acetonide (Triesence®)|"TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)~triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space"
11135945|NCT01789320|FG000|Participant Flow|Triamcinolone Acetonide (Triesence®)|"TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)~triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space"
11135946|NCT01789320|OG000|Outcome|Triamcinolone Acetonide (Triesence®)|"TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)~triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space"
11135947|NCT01789320|EG000|Reported Event|Triamcinolone Acetonide (Triesence®)|"TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)~triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space"
11135948|NCT01789476|BG000|Baseline|CR845|CR845 (0.005 mg/kg) IV
11135949|NCT01789476|BG001|Baseline|Placebo|Matched placebo
11135950|NCT01789476|BG002|Baseline|Total|Total of all reporting groups
11135951|NCT01789476|FG000|Participant Flow|CR845|CR845 (0.005 mg/kg) IV
11135952|NCT01789476|FG001|Participant Flow|Placebo|Matched placebo
11135953|NCT01789476|OG000|Outcome|Placebo|Matched placebo
11135954|NCT01789476|OG001|Outcome|CR845|CR845 (0.005 mg/kg) IV
11135955|NCT01789476|EG000|Reported Event|CR845|CR845 (0.005 mg/kg) IV
11135956|NCT01789476|EG001|Reported Event|Placebo|Matched placebo
11135957|NCT01789567|BG000|Baseline|Engager™ Aortic Valve|"Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach~Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach"
11135958|NCT01789567|FG000|Participant Flow|Engager™ Aortic Valve|"Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach~Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach"
11135959|NCT01789567|OG000|Outcome|Engager™ Aortic Valve|"Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach~Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach"
11135960|NCT01789567|EG000|Reported Event|Engager™ Aortic Valve|"Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach~Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach"
11135961|NCT01789606|BG000|Baseline|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
11135962|NCT01789606|BG001|Baseline|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
11135963|NCT01789606|BG002|Baseline|Total|Total of all reporting groups
11135964|NCT01789606|FG000|Participant Flow|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
11135965|NCT01789606|FG001|Participant Flow|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
11135966|NCT01789606|OG000|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
11135967|NCT01789606|OG000|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
11135968|NCT01789606|EG000|Reported Event|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
11135969|NCT01789775|BG000|Baseline|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
11135970|NCT01789775|BG001|Baseline|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
11135971|NCT01789775|BG002|Baseline|Total|Total of all reporting groups
11135972|NCT01789775|FG000|Participant Flow|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
11135973|NCT01789775|FG001|Participant Flow|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
11135974|NCT01789775|OG000|Outcome|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
11135975|NCT01789775|OG001|Outcome|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
11135976|NCT01789775|EG000|Reported Event|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
11135977|NCT01789775|EG001|Reported Event|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
11135978|NCT01789814|BG000|Baseline|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
11135979|NCT01789814|BG001|Baseline|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
11135980|NCT01789814|BG002|Baseline|Total|Total of all reporting groups
11135981|NCT01789814|FG000|Participant Flow|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
11135982|NCT01789814|FG001|Participant Flow|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
11135983|NCT01789814|OG000|Outcome|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
11135984|NCT01789814|OG001|Outcome|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter~."
11135985|NCT01789814|EG000|Reported Event|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
11135986|NCT01789814|EG001|Reported Event|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
11135987|NCT01789840|BG000|Baseline|Prostate Artery Emoblization (PAE)|"Prostate artery embolization using Embosphere Microspheres~Embosphere Microspheres"
11135988|NCT01789840|BG001|Baseline|Transurethral Resection of the Prostate (TURP)|"Transurethral Resection of the Prostate (TURP)~TURP"
11135989|NCT01789840|BG002|Baseline|Total|Total of all reporting groups
11135990|NCT01789840|FG000|Participant Flow|Prostate Artery Emoblization (PAE)|"Prostate artery embolization using Embosphere Microspheres~Embosphere Microspheres"
11135991|NCT01789840|FG001|Participant Flow|Transurethral Resection of the Prostate (TURP)|"Transurethral Resection of the Prostate (TURP)~TURP"
11135992|NCT01789840|OG000|Outcome|Prostate Artery Emoblization (PAE)|"Prostate artery embolization using Embosphere Microspheres~Embosphere Microspheres"
11135993|NCT01789840|OG001|Outcome|Transurethral Resection of the Prostate (TURP)|"Transurethral Resection of the Prostate (TURP)~TURP"
11135994|NCT01789840|OG000|Outcome|Prostate Artery Embolization (PAE)|"Summary of treatment emergent adverse events presented as number of events in the PAE arm.~Denominator for percent calculations is 52 treated subjects. Subjects who were randomized and never treated are not included.~An AE is considered related to treatment if the Investigator assessment of relationship to study treatment was possible, probably, or definite.~If a subject had multiple reports of the same type of AE, he is only counted once for that AE. System organ class counts are number of subjects."
11135995|NCT01789840|OG001|Outcome|Transurethral Resection of Prostate (TURP)|"Summary of treatment emergent adverse events presented as number of events in the TURP arm.~Denominator for percent calculations is 6 treated subjects. Subjects who were randomized and never treated are not included.~An AE is considered related to treatment if the Investigator assessment of relationship to study treatment was possible, probably, or definite.~If a subject had multiple reports of the same type of AE, he is only counted once for that AE. System organ class counts are number of subjects."
11135996|NCT01789840|EG000|Reported Event|Prostate Artery Embolization (PAE) Arm|Denominator for percent calculations is 52 treated subjects. Subjects who were randomized and never treated are not included. If a subject had multiple reports of the same type of AE, he is only counted once for that AE.
11135997|NCT01789840|EG001|Reported Event|Transurethral Resection of the Prostate (TURP) Arm|Denominator for percent calculations is 6 treated subjects. Subjects who were randomized and never treated are not included. If a subject had multiple reports of the same type of AE, he is only counted once for that AE.
11135998|NCT01789905|BG000|Baseline|Tygacil (Tigecycline)|Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
11135999|NCT01789905|FG000|Participant Flow|Tygacil (Tigecycline)|Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
11136000|NCT01789905|OG000|Outcome|Tygacil (Tigecycline)|Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
11136001|NCT01789905|EG000|Reported Event|Tygacil (Tigecycline)|Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
11136002|NCT01789970|BG000|Baseline|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11136003|NCT01789970|BG001|Baseline|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered extended-release hydrocodone tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11136004|NCT01789970|BG002|Baseline|Total|Total of all reporting groups
11136005|NCT01789970|FG000|Participant Flow|Hydrocodone ER (Open-Label Titration Period)|All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
11136006|NCT01789970|FG001|Participant Flow|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11136007|NCT01789970|FG002|Participant Flow|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11136008|NCT01789970|OG000|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11136009|NCT01789970|OG001|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11136010|NCT01789970|OG000|Outcome|Opioid-Naive (Open-Label Titration Period)|"Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening.~Opioid-naïve participants started at a 15-mg dose of hydrocodone ER tablets every 12 hours.~All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain."
11136011|NCT01789970|OG001|Outcome|Opioid-Experienced (Open-Label Titration Period)|"Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening.~For opioid-experienced participants, the starting dose of hydrocodone ER tablets was to be approximately equivalent to 50% of the dose of opioid analgesic that they were receiving at screening and administered every 12 hours.~All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain."
11136012|NCT01789970|OG002|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11136013|NCT01789970|OG003|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11136014|NCT01789970|OG000|Outcome|Hydrocodone ER (Safety Analysis Set)|All enrolled participants who were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours. Includes days on hydrocodone ER during both the titration and treatment periods.
11136015|NCT01789970|OG001|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11136016|NCT01789970|OG002|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11136017|NCT01789970|EG000|Reported Event|Hydrocodone ER (Open-Label Titration Period)|All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
11136018|NCT01789970|EG001|Reported Event|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
10887374|NCT00500240|EG000|Reported Event|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
11136019|NCT01789970|EG002|Reported Event|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11136020|NCT01790048|BG000|Baseline|Whey Permeate RUSF|"75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Whey RUSF contains whey permeate, WPC 80 (contains"
11136021|NCT01790048|BG001|Baseline|Soy Protein RUSF|"75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Soy RUSF contains extruded soy"
11136022|NCT01790048|BG002|Baseline|Total|Total of all reporting groups
11136023|NCT01790048|FG000|Participant Flow|Whey Permeate RUSF|"75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Whey RUSF contains whey permeate, WPC 80 (contains"
11136024|NCT01790048|FG001|Participant Flow|Soy Protein RUSF|"75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Soy RUSF contains extruded soy"
11136025|NCT01790048|OG000|Outcome|Whey Permeate RUSF|"75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Whey RUSF contains whey permeate, WPC 80 (contains"
11136026|NCT01790048|OG001|Outcome|Soy Protein RUSF|"75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Soy RUSF contains extruded soy"
11149665|NCT01872325|BG000|Baseline|Training Site|"All emergency medical dispatchers at a central ambulance communication centre in Ontario will participate in an educational program designed to improve cardiac arrest diagnostic accuracy.~Education: An education program will be developed using behaviour change techniques specifically mapped to address modifiable factors identified in a previous study. These techniques will include: information about the significance of agonal breathing, modeling/demonstration of desired behavioural skills, rehearsal of desired skills, and monitoring/reinforcement and feedback."
11149666|NCT01872325|BG001|Baseline|Control Site|All emergency medical dispatchers at a central ambulance communications centre geographically remote from the Training Site and has a similar rate to the Training Site for cardiac arrests, bystander CPR rate, and survival
11149667|NCT01872325|BG002|Baseline|Total|Total of all reporting groups
11136027|NCT01790048|OG000|Outcome|Whey Permeate RUSF|"75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Whey RUSF contains whey permeate, WPC 80 (contains at"
11136028|NCT01790048|OG001|Outcome|Soy Protein RUSF|"75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Soy RUSF contains extruded soy flo"
11136029|NCT01790048|EG000|Reported Event|Whey Permeate RUSF|"75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Whey RUSF contains whey permeate, WPC 80 (contains"
11136030|NCT01790048|EG001|Reported Event|Soy Protein RUSF|"75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA.~Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.~Soy RUSF contains extruded soy f"
11136031|NCT01790113|BG000|Baseline|Active Comparator: Univer II|Univer II Total Shoulder Replacement
11136032|NCT01790113|BG001|Baseline|Experimental: Eclipse|Eclipse Total shoulder Replacement
11136033|NCT01790113|BG002|Baseline|Total|Total of all reporting groups
11136034|NCT01790113|FG000|Participant Flow|Univers™ II|"Univers™ II Total Shoulder Replacement~Univers™: Control"
11136035|NCT01790113|FG001|Participant Flow|Eclipse™|"Eclipse™ Total Shoulder Replacement~Eclipse™ Total Shoulder Replacement: Investigational"
11136036|NCT01790113|OG000|Outcome|Univer™ II|"Univers™ II Total Shoulder Replacement~Univers™: Control"
11136037|NCT01790113|OG001|Outcome|Eclipse™|"Eclipse™ Total Shoulder Replacement~Eclipse™ Total Shoulder Replacement: Investigational"
11136038|NCT01790113|EG000|Reported Event|Active Comparator: Univer II|Univer II Total Shoulder Replacement
11136039|NCT01790113|EG001|Reported Event|Experimental: Eclipse|Eclipse Total shoulder Replacement
11136040|NCT01790126|BG000|Baseline|Luteinizing Hormone Releasing Hormone Agonist (LHRHa)|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines up to 12 months, or shorter duration if evidence of prostate-specific antigen (PSA)/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study.
11136041|NCT01790126|BG001|Baseline|Apalutamide|Participants received apalutamide, 240 milligram (mg) soft-gel capsules (8*30 mg capsules) per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136042|NCT01790126|BG002|Baseline|LHRHa + Apalutamide|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines and apalutamide 240 mg soft-gel capsules per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136043|NCT01790126|BG003|Baseline|Total|Total of all reporting groups
11136044|NCT01790126|FG000|Participant Flow|Luteinizing Hormone Releasing Hormone Agonist (LHRHa)|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines up to 12 months, or shorter duration if evidence of prostate-specific antigen (PSA)/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study.
11136045|NCT01790126|FG001|Participant Flow|Apalutamide|Participants received apalutamide, 240 milligram (mg) soft-gel capsules (8*30 mg capsules) per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136046|NCT01790126|FG002|Participant Flow|LHRHa + Apalutamide|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines and apalutamide 240 mg soft-gel capsules per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136047|NCT01790126|OG000|Outcome|Luteinizing Hormone Releasing Hormone Agonist (LHRHa)|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines up to 12 months, or shorter duration if evidence of prostate-specific antigen (PSA)/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study.
11136048|NCT01790126|OG001|Outcome|Apalutamide|Participants received apalutamide, 240 milligram (mg) soft-gel capsules (8*30 mg capsules) per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136049|NCT01790126|OG002|Outcome|LHRHa + Apalutamide|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines and apalutamide 240 mg soft-gel capsules per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136050|NCT01790126|OG001|Outcome|LHRHa + Apalutamide|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines and apalutamide 240 mg soft-gel capsules per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136051|NCT01790126|EG000|Reported Event|Luteinizing Hormone Releasing Hormone Agonist (LHRHa)|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines up to 12 months, or shorter duration if evidence of prostate-specific antigen (PSA)/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study.
11136052|NCT01790126|EG001|Reported Event|Apalutamide|Participants received apalutamide, 240 milligram (mg) soft-gel capsules (8*30 mg capsules) per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136053|NCT01790126|EG002|Reported Event|LHRHa + Apalutamide|Participants received LHRHa injections either subcutaneously or intramuscularly as per investigator discretion/site practice guidelines and apalutamide 240 mg soft-gel capsules per day orally up to 12 months, or shorter duration if evidence of PSA/radiographic progression or unacceptable toxicity during protocol therapy or participant/physician withdrawal from the study. With Amendment 7, participants who were receiving the apalutamide soft-gel capsules were switched to the apalutamide tablet formulation (4*60 mg tablets).
11136054|NCT01790178|BG000|Baseline|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
11136055|NCT01790178|BG001|Baseline|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
11136056|NCT01790178|BG002|Baseline|Total|Total of all reporting groups
11136057|NCT01790178|FG000|Participant Flow|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
11136058|NCT01790178|FG001|Participant Flow|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
11136059|NCT01790178|OG000|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
11136060|NCT01790178|OG001|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
11136061|NCT01790178|EG000|Reported Event|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
11136062|NCT01790178|EG001|Reported Event|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
11136063|NCT01790243|BG000|Baseline|Lutonix Drug Coated Balloon|"Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter~Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries."
11136064|NCT01790243|BG001|Baseline|Standard Uncoated Angioplasty Balloon|"PTA Catheter~Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries."
11136065|NCT01790243|BG002|Baseline|Total|Total of all reporting groups
11136066|NCT01790243|FG000|Participant Flow|Lutonix Drug Coated Balloon|"Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter~Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries."
11136067|NCT01790243|FG001|Participant Flow|Standard Uncoated Angioplasty Balloon|"PTA Catheter~Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries."
11136068|NCT01790243|OG000|Outcome|Lutonix Drug Coated Balloon|"Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter~Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries."
11136069|NCT01790243|OG001|Outcome|Standard Uncoated Angioplasty Balloon|"PTA Catheter~Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries."
11136070|NCT01790243|EG000|Reported Event|Lutonix Drug Coated Balloon|"Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter~Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries."
11136071|NCT01790243|EG001|Reported Event|Standard Uncoated Angioplasty Balloon|"PTA Catheter~Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries."
11136072|NCT01790295|BG000|Baseline|Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT)|"Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis~Ruxolitinib (INC424) tablets started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib was determined according to baseline platelet count and modified according to platelet count at follow-up. The drug was given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug was supplied as 5 mg tablets."
11136073|NCT01790295|FG000|Participant Flow|Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT)|"Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis.~Ruxolitinib (INC424) tablets started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib was determined according to baseline platelet count and modified according to platelet count at follow-up. The drug was given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug was supplied as 5 mg tablets."
11136074|NCT01790295|OG000|Outcome|Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT)|"Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis~Ruxolitinib (INC424) tablets started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib was determined according to baseline platelet count and modified according to platelet count at follow-up. The drug was given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug was supplied as 5 mg tablets."
11136075|NCT01790295|OG000|Outcome|Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT)|Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis
11136076|NCT01790295|EG000|Reported Event|Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT)|"Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis~Ruxolitinib (INC424) tablets started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib was determined according to baseline platelet count and modified according to platelet count at follow-up. The drug was given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug was supplied as 5 mg tablets."
11136077|NCT01790438|BG000|Baseline|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
11136078|NCT01790438|BG001|Baseline|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
11136079|NCT01790438|BG002|Baseline|Total|Total of all reporting groups
11136080|NCT01790438|FG000|Participant Flow|LY2605541|Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 was given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
11136081|NCT01790438|FG001|Participant Flow|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin isophane suspension (NPH) was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
11136082|NCT01790438|OG000|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
11136083|NCT01790438|OG001|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
11136084|NCT01790438|OG000|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose is 10 units and is adjusted weekly based on FBG. LY2605541 will be given alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks.
11136085|NCT01790438|OG001|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose is 10 units and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal.
11136086|NCT01790438|EG000|Reported Event|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
11136087|NCT01790438|EG001|Reported Event|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
11136088|NCT01790490|BG000|Baseline|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
11136089|NCT01790490|BG001|Baseline|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
11136090|NCT01790490|BG002|Baseline|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
11136091|NCT01790490|BG003|Baseline|Total|Total of all reporting groups
11136092|NCT01790490|FG000|Participant Flow|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
11136093|NCT01790490|FG001|Participant Flow|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
11136094|NCT01790490|FG002|Participant Flow|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
11136095|NCT01790490|OG000|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|"Ketamine 0.41 mg/kg infused over 52 min (K1)~Ketamine 0.41 mg/kg: 52 minute iv infusion of ketamine 0.41 mg/kg"
11136096|NCT01790490|OG001|Outcome|Ketamine Infusion 0.71 mg/kg Over 52 Minutes (K2)|"Ketamine 0.71 mg/kg infused over 52 min (K2)~Ketamine 0.71 mg/kg: 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings."
11136097|NCT01790490|OG002|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|"Lorazepam 2 mg infused over 52 minutes (LZP)~Lorazepam 2 mg: 52 minute infusion of lorazepam 2 mg. This serves as an active control."
11136098|NCT01790490|OG000|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
11136099|NCT01790490|OG001|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
11136100|NCT01790490|OG002|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP) Following K1|Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
11136101|NCT01790490|EG000|Reported Event|Ketamine 0.41 (K1)|Ketamine 0.41 (K1) over 52 minutes
11136102|NCT01790490|EG001|Reported Event|Lorazepam 2 mg (LZP)|Lorazepam 2 mg (LZP) over 52 minutes
11136103|NCT01790490|EG002|Reported Event|Ketamine 0.71 (K2)|Ketamine 0.71 mg/kg over 52 minutes (K2)
11136104|NCT01790503|BG000|Baseline|Phase 1b Dose Escalation - 600 mg/600 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136105|NCT01790503|BG001|Baseline|Phase 1b Dose Escalation - 600 mg/800 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136106|NCT01790503|BG002|Baseline|Phase 1b Dose Escalation - 600 mg/1000 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136107|NCT01790503|BG003|Baseline|Phase 1b Dose Escalation - 600 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter
11136108|NCT01790503|BG004|Baseline|Phase 1b Dose Escalation - 800 mg/1000 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136109|NCT01790503|BG005|Baseline|Phase 1b Dose Escalation - 800 mg (5 Days)|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136110|NCT01790503|BG006|Baseline|Phase 1b Dose Escalation - 800 mg/600 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136111|NCT01790503|BG007|Baseline|Phase 1b Dose Escalation - 800 mg/800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136112|NCT01790503|BG008|Baseline|Phase 1b Dose Escation - 800 mg (7 Days)|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
11136113|NCT01790503|BG009|Baseline|Phase 2 - 800 mg/800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136114|NCT01790503|BG010|Baseline|Phase 2 - 800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136115|NCT01790503|BG011|Baseline|Total|Total of all reporting groups
11136116|NCT01790503|FG000|Participant Flow|Phase 1b Dose Escalation - 600 mg/600 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136117|NCT01790503|FG001|Participant Flow|Phase 1b Dose Escalation - 600 mg/800 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter
11136118|NCT01790503|FG002|Participant Flow|Phase 1b Dose Escalation - 600 mg/1000 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136119|NCT01790503|FG003|Participant Flow|Phase 1b Dose Escalation - 600 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.
11136120|NCT01790503|FG004|Participant Flow|Phase 1b Dose Escalation - 800 mg/1000 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136121|NCT01790503|FG005|Participant Flow|Phase 1b Dose Escalation - 800 mg (5 Days)|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136122|NCT01790503|FG006|Participant Flow|Phase 1b Dose Escalation - 800 mg/600 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136123|NCT01790503|FG007|Participant Flow|Phase 1b Dose Escalation - 800 mg/800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136124|NCT01790503|FG008|Participant Flow|Phase 1b Dose Escalation - 800 mg (7 Days)|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
11136125|NCT01790503|FG009|Participant Flow|Phase 2 - 800 mg/800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136126|NCT01790503|FG010|Participant Flow|Phase 2 - 800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136127|NCT01790503|OG000|Outcome|Combined 800 mg, 5 Days/Week|All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
11136128|NCT01790503|OG000|Outcome|RP2D|mPFS was assessed in the RP2D population at Cycle 1, Day 1.
11136129|NCT01790503|OG001|Outcome|RP2D-0525 (Cycle 1, Day 1)|mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
11136130|NCT01790503|OG002|Outcome|RP2D-0825|mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
11136131|NCT01790503|OG003|Outcome|RP2D-0525 (Rest Period, Day 15)|mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
11136132|NCT01790503|OG000|Outcome|RP2D|OS was assessed in the RP2D population at Cycle 1, Day 1.
11136133|NCT01790503|OG001|Outcome|RP2D-0525 (Cycle 1, Day 1)|OS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
11136134|NCT01790503|OG002|Outcome|RP2D-0825|OS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
11136135|NCT01790503|OG003|Outcome|RP2D-0525 (Rest Period, Day 15)|OS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
11136136|NCT01790503|OG000|Outcome|Phase 1b Dose Escalation - 600 mg/600 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136137|NCT01790503|OG001|Outcome|Phase 1b Dose Escalation - 600 mg/800 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136138|NCT01790503|OG002|Outcome|Phase 1b Dose Escalation - 600 mg/1000 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136139|NCT01790503|OG003|Outcome|Phase 1b Dose Escalation - 600 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.
11136140|NCT01790503|OG004|Outcome|Phase 1b Dose Escalation - 800 mg/1000 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136141|NCT01790503|OG005|Outcome|Phase 1b Dose Escalation - 800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136142|NCT01790503|OG006|Outcome|Phase 1b Dose Escalation - 800 mg/600 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136143|NCT01790503|OG007|Outcome|Phase 1b Dose Escalation - 800 mg/800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136144|NCT01790503|OG008|Outcome|Phase 1b Dose Escation - 800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136145|NCT01790503|OG000|Outcome|Phase 2 - 800 mg/800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136146|NCT01790503|OG001|Outcome|Phase 2 - 800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136147|NCT01790503|OG002|Outcome|Phase 2 Total|All participants in Phase 2 who received 800 mg/day PLX3397 in combination therapy.
11136148|NCT01790503|OG003|Outcome|Combined 800 mg, 5 Days/Week|All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
11136149|NCT01790503|OG005|Outcome|Phase 1b Dose Escalation - 800 mg (5 Days)|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136150|NCT01790503|OG008|Outcome|Phase 1b Dose Escation - 800 mg (No Adjuvant Therapy)|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
11136151|NCT01790503|EG000|Reported Event|Phase 1b Dose Escalation - 600 mg/600 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136152|NCT01790503|EG001|Reported Event|Phase 1b Dose Escalation - 600 mg/800 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136153|NCT01790503|EG002|Reported Event|Phase 1b Dose Escalation - 600 mg/1000 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136154|NCT01790503|EG003|Reported Event|Phase 1b Dose Escalation - 600 mg|Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.
11136155|NCT01790503|EG004|Reported Event|Phase 1b Dose Escalation - 800 mg/1000 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136156|NCT01790503|EG005|Reported Event|Phase 1b Dose Escalation - 800 mg (5 Days)|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136157|NCT01790503|EG006|Reported Event|Phase 1b Dose Escalation - 800 mg/600 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136158|NCT01790503|EG007|Reported Event|Phase 1b Dose Escalation - 800 mg/800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136159|NCT01790503|EG008|Reported Event|Phase 1b Dose Escation - 800 mg (7 Days)|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
11136160|NCT01790503|EG009|Reported Event|Phase 2 - 800 mg/800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
11136161|NCT01790503|EG010|Reported Event|Phase 2 - 800 mg|Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
11136162|NCT01790516|BG000|Baseline|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
11136163|NCT01790516|BG001|Baseline|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
11136164|NCT01790516|BG002|Baseline|Total|Total of all reporting groups
11136165|NCT01790516|FG000|Participant Flow|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
11136166|NCT01790516|FG001|Participant Flow|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
11136167|NCT01790516|OG000|Outcome|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
11136168|NCT01790516|OG001|Outcome|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
11136169|NCT01790516|EG000|Reported Event|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
11136170|NCT01790516|EG001|Reported Event|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
11136171|NCT01790568|BG000|Baseline|Vorinostat|"Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
11136172|NCT01790568|FG000|Participant Flow|Vorinostat|"NCI sponsored pilot trial of Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
11136173|NCT01790568|FG001|Participant Flow|Vorinostat Expansion|"Expansion of the NCI sponsored pilot trial of Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
11136174|NCT01790568|OG000|Outcome|Vorinostat|"Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
11136175|NCT01790568|EG000|Reported Event|Vorinostat|"Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
11136176|NCT01790581|BG000|Baseline|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
11136177|NCT01790581|BG001|Baseline|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
11136178|NCT01790581|BG002|Baseline|Total|Total of all reporting groups
11136179|NCT01790581|FG000|Participant Flow|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
11136180|NCT01790581|FG001|Participant Flow|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised sessions. Exercises and repetitions per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
11136181|NCT01790581|OG000|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
11136182|NCT01790581|OG001|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
11136183|NCT01790581|EG000|Reported Event|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
11136184|NCT01790581|EG001|Reported Event|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
11136185|NCT01790594|BG000|Baseline|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
11136186|NCT01790594|BG001|Baseline|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
11136187|NCT01790594|BG002|Baseline|Total|Total of all reporting groups
11136188|NCT01790594|FG000|Participant Flow|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
11136189|NCT01790594|FG001|Participant Flow|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
11136190|NCT01790594|FG002|Participant Flow|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
11136191|NCT01790594|OG000|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
11136192|NCT01790594|OG001|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
11136193|NCT01790594|EG000|Reported Event|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
11136194|NCT01790594|EG001|Reported Event|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
11136195|NCT01790594|EG002|Reported Event|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
11136196|NCT01790633|BG000|Baseline|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
11136197|NCT01790633|BG001|Baseline|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
11136198|NCT01790633|BG002|Baseline|Total|Total of all reporting groups
11136199|NCT01790633|FG000|Participant Flow|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
11136200|NCT01790633|FG001|Participant Flow|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
11136201|NCT01790633|OG000|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
11136202|NCT01790633|OG001|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
11136203|NCT01790633|OG000|Outcome|Screened for Eligibility|Individuals who were screened for eligibility, prior to being considered for randomization.
11136204|NCT01790633|EG000|Reported Event|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
11136205|NCT01790633|EG001|Reported Event|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
11136206|NCT01790659|BG000|Baseline|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
11136207|NCT01790659|BG001|Baseline|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
11136208|NCT01790659|BG002|Baseline|Total|Total of all reporting groups
11136209|NCT01790659|FG000|Participant Flow|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
11136210|NCT01790659|FG001|Participant Flow|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
11136211|NCT01790659|OG000|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
11136212|NCT01790659|OG001|Outcome|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
11136213|NCT01790659|EG000|Reported Event|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
11136214|NCT01790659|EG001|Reported Event|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
11136215|NCT01790685|BG000|Baseline|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
11136216|NCT01790685|BG001|Baseline|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
11136217|NCT01790685|BG002|Baseline|Total|Total of all reporting groups
11136218|NCT01790685|FG000|Participant Flow|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
11136219|NCT01790685|FG001|Participant Flow|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
11136220|NCT01790685|OG000|Outcome|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
11136221|NCT01790685|OG001|Outcome|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
11136222|NCT01790685|EG000|Reported Event|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
11136223|NCT01790685|EG001|Reported Event|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
11136224|NCT01790750|BG000|Baseline|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
11136225|NCT01790750|FG000|Participant Flow|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
11136226|NCT01790750|OG000|Outcome|PES First, Then FFES|A 5-minutePocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
11136227|NCT01790750|OG000|Outcome|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
11136228|NCT01790750|EG000|Reported Event|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
11136229|NCT01790828|BG000|Baseline|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
11136230|NCT01790828|FG000|Participant Flow|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
11136231|NCT01790828|OG000|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
11136232|NCT01790828|EG000|Reported Event|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
11136233|NCT01790932|BG000|Baseline|BKM120|"BKM120: 100 mg capsule once daily each day of a 28 day cycle .~Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons."
11136234|NCT01790932|FG000|Participant Flow|BKM120|"BKM120: 100 mg capsule once daily each day of a 28 day cycle .~Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons."
11136235|NCT01790932|OG000|Outcome|BKM120|"BKM120: 100 mg capsule once daily each day of a 28 day cycle .~Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons."
11136236|NCT01790932|EG000|Reported Event|BKM120|"BKM120: 100 mg capsule once daily each day of a 28 day cycle .~Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons."
11136237|NCT01790984|BG000|Baseline|NAFLD (>5% Liver Fat)|Men with non-alcoholic fatty liver disease (NAFLD) n=12
11136238|NCT01790984|BG001|Baseline|Controls (<5% Liver Fat)|Controls (men without NAFLD <5% liver fat) n=15
11136239|NCT01790984|BG002|Baseline|Total|Total of all reporting groups
11136240|NCT01790984|FG000|Participant Flow|High Sugar / NAFLD|"Men with NAFLD (>5% liver fat) on a high sugar diet (25% total energy)~Please note: This was a randomised cross-over study. The men with NAFLD and Controls were randomised to either diet in the 'First Dietary Intervention (12 weeks)' period, and after the 'Wash-out (4 weeks)' period, crossed-over to the alternate diet in the 'Second Dietary Intervention (12 weeks)' period. This is why the number completing the First Intervention is not the same as the number starting the Second Dietary Intervention."
11136241|NCT01790984|FG001|Participant Flow|High Sugar / Controls|"Controls (<5% liver fat) on a high sugar (HS) diet.~Please note: This was a randomised cross-over study. The men with NAFLD and Controls were randomised to either diet in the 'First Dietary Intervention (12 weeks)' period, and after the 'Wash-out (4 weeks)' period, crossed-over to the alternate diet in the 'Second Dietary Intervention (12 weeks)' period. This is why the number completing the First Intervention is not the same as the number starting the Second Dietary Intervention."
11136242|NCT01790984|FG002|Participant Flow|Low Sugar / NAFLD|"Men with NAFLD (>5% liver fat) on a low sugar diet.~Please note: This was a randomised cross-over study. The men with NAFLD and Controls were randomised to either diet in the 'First Dietary Intervention (12 weeks)' period, and after the 'Wash-out (4 weeks)' period, crossed-over to the alternate diet in the 'Second Dietary Intervention (12 weeks)' period. This is why the number completing the First Intervention is not the same as the number starting the Second Dietary Intervention."
11136243|NCT01790984|FG003|Participant Flow|Low Sugar / Controls|"Controls with low liver fat (<5%) on a low sugar diet (5% total energy)~Please note: This was a randomised cross-over study. The men with NAFLD and Controls were randomised to either diet in the 'First Dietary Intervention (12 weeks)' period, and after the 'Wash-out (4 weeks)' period, crossed-over to the alternate diet in the 'Second Dietary Intervention (12 weeks)' period. This is why the number completing the First Intervention is not the same as the number starting the Second Dietary Intervention."
11136244|NCT01790984|OG000|Outcome|High Sugar Diet (12 Weeks) in Men With NAFLD|A high sugar (27% total energy), low starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar 1: 1.2.
11136245|NCT01790984|OG001|Outcome|Low Sugar Diet (12 Weeks) in Men With NAFLD|A low sugar (9% total energy), high starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by replacing foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1
11136246|NCT01790984|OG002|Outcome|High Sugar Diet (12 Weeks) in Controls|A high sugar (28% total energy), low starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar 1: 1.2.
11136247|NCT01790984|OG003|Outcome|Low Sugar Diet (12 Weeks) in Controls|A low sugar (10% total energy), high starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by replacing foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1.
11136248|NCT01790984|OG001|Outcome|Low Sugar Diet (12 Weeks) in Men With NAFLD|A low sugar (9% total energy), high starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1
11136249|NCT01790984|OG002|Outcome|High Sugar Diet (12 Weeks) in Controls|A high sugar (28% total energy), low starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar 1: 1.2
11136250|NCT01790984|OG003|Outcome|Low Sugar Diet (12 Weeks) in Controls|A low sugar (10% total energy), high starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1
11136251|NCT01790984|OG000|Outcome|High Sugar Diet (12 Weeks) in Men With NAFLD|A high sugar diet (27% total energy), low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar of 1:1.2
11136252|NCT01790984|OG001|Outcome|Low Sugar Diet (12 Weeks) in Men With NAFLD|A low sugar (9% total energy), high starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by replacing foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1.
11136253|NCT01790984|OG002|Outcome|High Sugar Diet (12 Weeks) in Controls|A high sugar diet (28% total energy), low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar of 1:1.2.
11136254|NCT01790984|OG003|Outcome|Low Sugar Diet (12 Weeks) in Controls|A low sugar (9% total energy), high starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by replacing foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1.
11136255|NCT01790984|OG000|Outcome|High Sugar Diet (12 Weeks) in Men With NAFLD|A high sugar (27%), low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar of 1:1.2
11136256|NCT01790984|OG001|Outcome|Low Sugar Diet (12 Weeks) in Men With NAFLD|A low sugar (9%), low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1
11136257|NCT01790984|OG002|Outcome|High Sugar Diet (12 Weeks) in Controls|A high sugar (28%), low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar of 1:1.2
11136258|NCT01790984|OG003|Outcome|Low Sugar Diet (12 Weeks) in Controls|A low sugar (10%), low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1
11136259|NCT01790984|OG000|Outcome|High Sugar Diet (12 Weeks) in Men With NAFLD|A high sugar (27% total energy), low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar of 1:1.2.
11136260|NCT01790984|OG002|Outcome|High Sugar Diet (12 Weeks) in Controls|A high sugar (28% total energy), low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar of 1:1.2.
11136261|NCT01790984|EG000|Reported Event|High Sugar Diet in NAFLD Men (n=11)|A high sugar (27% total energy), low starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar 1: 1.2.
11136262|NCT01790984|EG001|Reported Event|Low Sugar Diet in NAFLD Men (n=11)|A low sugar (9% total energy), high starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by replacing foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1.
11136263|NCT01790984|EG002|Reported Event|High Sugar Diet in Controls (n=14)|A high sugar (28% total energy), low starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar 1: 1.2.
11136264|NCT01790984|EG003|Reported Event|Low Sugar Diet in Controls (n=14)|A low sugar (10% total energy), high starch diet was provided by the exchange of 66% of the participants daily intake of carbohydrate. This was achieved by replacing foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1.
11136265|NCT01791127|BG000|Baseline|BIOTRONIK Siello S Lead|Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
11136266|NCT01791127|FG000|Participant Flow|BIOTRONIK Siello S Lead|Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
11136267|NCT01791127|OG000|Outcome|BIOTRONIK Siello S Atrial Lead|Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
11136268|NCT01791127|OG000|Outcome|BIOTRONIK Siello S Ventricular Lead|Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S ventricular lead.
11136269|NCT01791127|OG000|Outcome|BIOTRONIK Siello S Lead|Patients in the pre-market cohort with a BIOTRONIK pacemaker system including one or two Siello S leads.
11136270|NCT01791127|OG000|Outcome|BIOTRONIK Siello S Ventricular Lead|Patients with a BIOTRONIK pacemaker system including a Siello S ventricular lead.
11136271|NCT01791127|OG000|Outcome|BIOTRONIK Siello S Atrial Lead|Patients with a BIOTRONIK pacemaker system including Siello S atrial lead.
11136272|NCT01791127|OG000|Outcome|Siello S Ventricular Leads|All originally implanted ventricular Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
11136273|NCT01791127|OG001|Outcome|Siello S Atrial Leads|All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
11136274|NCT01791127|OG000|Outcome|Siello S Ventricular Leads|All originally implanted ventricular Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.
11136275|NCT01791127|OG001|Outcome|Siello S Atrial Leads|All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.
11136276|NCT01791127|OG000|Outcome|BIOTRONIK Siello S Lead|Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
11136277|NCT01791127|OG000|Outcome|Siello S Ventricular Leads|All originally implanted ventricular Siello leads with follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
11136278|NCT01791127|OG001|Outcome|Siello S Atrial Leads|All originally implanted atrial Siello leads with follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
11136279|NCT01791127|OG000|Outcome|Siello S Ventricular Leads|All originally implanted ventricular Siello leads with follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.
11136280|NCT01791127|OG001|Outcome|Siello S Atrial Leads|All originally implanted atrial Siello leads with follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.
11136281|NCT01791127|EG000|Reported Event|BIOTRONIK Siello S Lead|Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
11136282|NCT01791153|BG000|Baseline|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136283|NCT01791153|BG001|Baseline|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136284|NCT01791153|BG002|Baseline|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136285|NCT01791153|BG003|Baseline|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
11136286|NCT01791153|BG004|Baseline|Total|Total of all reporting groups
11136287|NCT01791153|FG000|Participant Flow|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection every week (qw) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136288|NCT01791153|FG001|Participant Flow|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection every 2 weeks (q2w) (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136289|NCT01791153|FG002|Participant Flow|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136290|NCT01791153|FG003|Participant Flow|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
11136291|NCT01791153|FG004|Participant Flow|Part 2: No Tocilizumab (Placebo in Part 1)|Participants did not receive tocilizumab in Part 2 from Week 52 up to Week 156. These participants received placebo during Part 1 (Weeks 1 to 52).
11136292|NCT01791153|FG005|Participant Flow|Part 2: No Tocilizumab (Tocilizumab in Part 1)|Participants did not receive tocilizumab in Part 2 from Week 52 up to Week 156. These participants received tocilizumab during Part 1 (Weeks 1 to 52).
11136293|NCT01791153|FG006|Participant Flow|Part 2: Tocilizumab (Placebo in Part 1)|Participants received open-label tocilizumab as determined by the investigator during Part 2 of the study (from Week 52 up to Week 156). These participants received placebo during Part 1 (Weeks 1 to 52).
11136294|NCT01791153|FG007|Participant Flow|Part 2: Tocilizumab (Tocilizumab in Part 1)|Participants received open-label tocilizumab as determined by the investigator during Part 2 of the study (from Week 52 up to Week 156). These participants received tocilizumab during Part 1 (Weeks 1 to 52).
11136295|NCT01791153|OG000|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136296|NCT01791153|OG001|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136297|NCT01791153|OG002|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136298|NCT01791153|OG002|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
11136299|NCT01791153|OG003|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
11136300|NCT01791153|EG000|Reported Event|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136301|NCT01791153|EG001|Reported Event|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136302|NCT01791153|EG002|Reported Event|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11136303|NCT01791153|EG003|Reported Event|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
11136304|NCT01791153|EG004|Reported Event|Part 2: No Tocilizumab (Placebo in Part 1)|Participants did not receive tocilizumab in Part 2 from Week 52 up to Week 156. These participants received placebo during Part 1 (Weeks 1 to 52).
11136305|NCT01791153|EG005|Reported Event|Part 2: No Tocilizumab (Tocilizumab in Part 1)|Participants did not receive tocilizumab in Part 2 from Week 52 up to Week 156. These participants received tocilizumab during Part 1 (Weeks 1 to 52).
11136306|NCT01791153|EG006|Reported Event|Part 2: Tocilizumab (Placebo in Part 1)|Participants received open-label tocilizumab as determined by the investigator during Part 2 of the study (from Week 52 up to Week 156). These participants received placebo during Part 1 (Weeks 1 to 52).
11136307|NCT01791153|EG007|Reported Event|Part 2: Tocilizumab (Tocilizumab in Part 1)|Participants received open-label tocilizumab as determined by the investigator during Part 2 of the study (from Week 52 up to Week 156). These participants received tocilizumab during Part 1 (Weeks 1 to 52).
11136308|NCT01791205|BG000|Baseline|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
11136309|NCT01791205|BG001|Baseline|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
11136310|NCT01791205|BG002|Baseline|Total|Total of all reporting groups
11136311|NCT01791205|FG000|Participant Flow|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
11136312|NCT01791205|FG001|Participant Flow|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
11136313|NCT01791205|OG000|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
11136314|NCT01791205|OG001|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
11136315|NCT01791205|OG001|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
11136316|NCT01791205|EG000|Reported Event|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
11136317|NCT01791244|BG000|Baseline|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
11136318|NCT01791244|BG001|Baseline|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
11136319|NCT01791244|BG002|Baseline|Total|Total of all reporting groups
11136320|NCT01791244|FG000|Participant Flow|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
11136321|NCT01791244|FG001|Participant Flow|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
11136322|NCT01791244|OG000|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
11136323|NCT01791244|OG001|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
11136324|NCT01791244|OG000|Outcome|Patient Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
11136325|NCT01791244|OG000|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
11136326|NCT01791244|EG000|Reported Event|Patient Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
11136327|NCT01791244|EG001|Reported Event|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
11136328|NCT01791413|BG000|Baseline|No Depot Medroxyprogesterone Acetate|
11136329|NCT01791413|BG001|Baseline|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
11136330|NCT01791413|BG002|Baseline|Total|Total of all reporting groups
11136331|NCT01791413|FG000|Participant Flow|No Depot Medroxyprogesterone Acetate|
11136332|NCT01791413|FG001|Participant Flow|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
11136333|NCT01791413|OG000|Outcome|2 wk Post op : No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
11136334|NCT01791413|OG001|Outcome|2 wk Post op:Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
11136335|NCT01791413|OG002|Outcome|3 mo. Post op: No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
11136336|NCT01791413|OG003|Outcome|3 mo. Post op: Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
11136337|NCT01791413|EG000|Reported Event|DMPA|
11136338|NCT01791465|BG000|Baseline|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide
11136339|NCT01791465|FG000|Participant Flow|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
11136340|NCT01791465|OG000|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
11136341|NCT01791465|OG000|Outcome|Bydureon Treatment|"Treatment for 16 weeks with extended-release Exenatide (Bydureon)~extended-release exenatide: Single arm study - 2mg Bydureon every 7 days x 16 weeks"
11136342|NCT01791465|EG000|Reported Event|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
11136343|NCT01791491|BG000|Baseline|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
11136344|NCT01791491|FG000|Participant Flow|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
11136345|NCT01791491|OG000|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
11136346|NCT01791491|EG000|Reported Event|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
11136347|NCT01791517|BG000|Baseline|Etafilcon A|All subjects that were randomized to the study lens etafilcon A and 1 of 12 possible solution sequences.
11136348|NCT01791517|BG001|Baseline|Galyfilcon A|All subjects that were randomized to the study lens galyfilcon A and 1 of 12 possible solution sequences.
11136349|NCT01791517|BG002|Baseline|Senofilcon A|All subjects that were randomized to the study lens senofilcon A and 1 of 12 possible solution sequences.
11136350|NCT01791517|BG003|Baseline|Total|Total of all reporting groups
11136351|NCT01791517|FG000|Participant Flow|Biotrue/PureMoist/Revitalens/Clear Care|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136352|NCT01791517|FG001|Participant Flow|Biotrue/RevitaLens/Clear Care/PureMoist|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136353|NCT01791517|FG002|Participant Flow|Biotrue/Clear Care/PureMoist/RevitaLens|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136354|NCT01791517|FG003|Participant Flow|PureMoist/Biotrue/Clear Care/RevitaLens|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136355|NCT01791517|FG004|Participant Flow|PureMoist/RevitaLens/Biotrue/Clear Care|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136356|NCT01791517|FG005|Participant Flow|PureMoist/Clear Care/RevitaLens/Biotrue|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136357|NCT01791517|FG006|Participant Flow|RevitaLens/Biotrue/PureMoist/Clear Care|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136358|NCT01791517|FG007|Participant Flow|RevitaLens/PureMoist/Clear Care/Biotrue|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136359|NCT01791517|FG008|Participant Flow|RevitaLens/Clear Care/Biotrue/PureMoist|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136360|NCT01791517|FG009|Participant Flow|Clear Care/Biotrue/RevitaLens/PureMoist|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136361|NCT01791517|FG010|Participant Flow|Clear Care/PureMoist/Biotrue/RevitaLens|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136362|NCT01791517|FG011|Participant Flow|Clear Care/RevitaLens/PureMoist/Biotrue|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
11136363|NCT01791517|OG000|Outcome|Solution 1(RevitaLens)|Subjects that received solution 1 during any of the 4 study periods.
11136364|NCT01791517|OG001|Outcome|Solution 2(PureMoist)|Subjects that received solution 2 during any of the 4 study periods.
11136365|NCT01791517|OG002|Outcome|Solution 3(Biotrue)|Subjects that received solution 3 during any of the 4 study periods.
11136366|NCT01791517|OG003|Outcome|Solution 4(Clear Care)|Subjects that received solution 4 during any of the 4 study periods.
11136367|NCT01791517|EG000|Reported Event|Solution 1(RevitaLens): Senofilcon A|Subjects that were randomized to the senofilcon A lens and received solution 1 during any of the 4 study periods.
10887375|NCT00500240|EG001|Reported Event|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
11136368|NCT01791517|EG001|Reported Event|Solution 1 (RevitaLens): Galyfilcon A|Subjects that were randomized to the galyfilcon A lens and received solution 1 during any of the 4 study periods.
11136369|NCT01791517|EG002|Reported Event|Solution 1(RevitaLens): Etafilcon A|Subjects that were randomized to the etafilcon A lens and received solution 1 during any of the 4 study periods.
11136370|NCT01791517|EG003|Reported Event|Solution 2(PureMoist):Senofilcon A|Subjects were randomized to the senofilcon A lens and that received solution 2 during any of the 4 study periods.
11136371|NCT01791517|EG004|Reported Event|Solution 2(PureMoist): Galyfilcon A|Subjects were randomized to the galyfilcon A lens and that received solution 2 during any of the 4 study periods.
11136372|NCT01791517|EG005|Reported Event|Solution 2(PureMoist): Etafilcon A|Subjects were randomized to the etafilcon A lens and that received solution 2 during any of the 4 study periods.
11136373|NCT01791517|EG006|Reported Event|Solution 3(Biotrue): Senofilcon A|Subjects that were randomized to the senofilcon A lens and received solution 3 during any of the 4 study periods.
11136374|NCT01791517|EG007|Reported Event|Solution 3(Biotrue): Galyfilcon A|Subjects that were randomized to the galyfilcon A lens and received solution 3 during any of the 4 study periods.
11136375|NCT01791517|EG008|Reported Event|Solution 3(Biotrue): Etafilcon A|Subjects that were randomized to the etafilcon A lens and received solution 3 during any of the 4 study periods.
11136376|NCT01791517|EG009|Reported Event|Solution 4(Clear Care): Senofilcon A|Subjects that were randomized to the senofilcon A lens and received solution 4 during any of the 4 study periods.
11136377|NCT01791517|EG010|Reported Event|Solution 4(Clear Care): Galyfilcon A|Subjects that were randomized to the galyfilcon A lens and received solution 4 during any of the 4 study periods.
11136378|NCT01791517|EG011|Reported Event|Solution 4(Clear Care): Etafilcon A|Subjects that were randomized to the etafilcon A lens and received solution 4 during any of the 4 study periods.
11149668|NCT01872325|FG000|Participant Flow|Training Site|"All emergency medical dispatchers at a central ambulance communication centre in Ontario will participate in an educational program designed to improve cardiac arrest diagnostic accuracy.~Education: An education program will be developed using behaviour change techniques specifically mapped to address modifiable factors identified in a previous study. These techniques will include: information about the significance of agonal breathing, modeling/demonstration of desired behavioural skills, rehearsal of desired skills, and monitoring/reinforcement and feedback."
11149669|NCT01872325|FG001|Participant Flow|Control Site|All emergency medical dispatchers at a central ambulance communications centre geographically remote from the Training Site and has a similar rate to the Training Site for cardiac arrests, bystander CPR rate, and survival
11149670|NCT01872325|OG000|Outcome|Training Site|"All emergency medical dispatchers at a central ambulance communication centre in Ontario will participate in an educational program designed to improve cardiac arrest diagnostic accuracy.~Education: An education program will be developed using behaviour change techniques specifically mapped to address modifiable factors identified in a previous study. These techniques will include: information about the significance of agonal breathing, modeling/demonstration of desired behavioural skills, rehearsal of desired skills, and monitoring/reinforcement and feedback."
11149671|NCT01872325|OG001|Outcome|Control Site|All emergency medical dispatchers at a central ambulance communications centre geographically remote from the Training Site and has a similar rate to the Training Site for cardiac arrests, bystander CPR rate, and survival
11149672|NCT01872325|EG000|Reported Event|Training Site|"All emergency medical dispatchers at a central ambulance communication centre in Ontario will participate in an educational program designed to improve cardiac arrest diagnostic accuracy.~Education: An education program will be developed using behaviour change techniques specifically mapped to address modifiable factors identified in a previous study. These techniques will include: information about the significance of agonal breathing, modeling/demonstration of desired behavioural skills, rehearsal of desired skills, and monitoring/reinforcement and feedback."
11149673|NCT01872325|EG001|Reported Event|Control Site|All emergency medical dispatchers at a central ambulance communications centre geographically remote from the Training Site and has a similar rate to the Training Site for cardiac arrests, bystander CPR rate, and survival
11149674|NCT01872338|BG000|Baseline|Mindfulness-Based Cognitive Therapy + Treatment As Usual|"Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.~Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk."
11149675|NCT01872338|BG001|Baseline|Treatment As Usual|"VA standard care for suicide prevention~Treatment as usual: VA standard care for suicide prevention"
11149676|NCT01872338|BG002|Baseline|Total|Total of all reporting groups
11149677|NCT01872338|FG000|Participant Flow|Mindfulness-Based Cognitive Therapy + Treatment As Usual|"Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.~Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk."
11149678|NCT01872338|FG001|Participant Flow|Treatment As Usual|"VA standard care for suicide prevention~Treatment as usual: VA standard care for suicide prevention"
11149679|NCT01872338|OG000|Outcome|Mindfulness-Based Cognitive Therapy + Treatment As Usual|"Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.~Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk."
11149680|NCT01872338|OG001|Outcome|Treatment As Usual|"VA standard care for suicide prevention~Treatment as usual: VA standard care for suicide prevention"
11149681|NCT01872338|EG000|Reported Event|Mindfulness-Based Cognitive Therapy + Treatment As Usual|"Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.~Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk."
11149682|NCT01872338|EG001|Reported Event|Treatment As Usual|"VA standard care for suicide prevention~Treatment as usual: VA standard care for suicide prevention"
11149683|NCT01872611|BG000|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
11149684|NCT01872611|BG001|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
11149685|NCT01872611|BG002|Baseline|Total|Total of all reporting groups
11149686|NCT01872611|FG000|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
11149687|NCT01872611|FG001|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
11149688|NCT01872611|OG000|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
11149689|NCT01872611|OG001|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
11149690|NCT01872611|EG000|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
11149691|NCT01872611|EG001|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
11149692|NCT01872611|EG002|Reported Event|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
11136379|NCT01791725|BG000|Baseline|ELND005 BID|"ELND005 250 mg BID~ELND005"
11136380|NCT01791725|BG001|Baseline|ELND005 QD|"ELND005 250 mg QD~ELND005"
11136381|NCT01791725|BG002|Baseline|Placebo|"Placebo BID~Placebo"
11136382|NCT01791725|BG003|Baseline|Total|Total of all reporting groups
11136383|NCT01791725|FG000|Participant Flow|ELND005 BID|"ELND005 250 mg BID~ELND005"
11136384|NCT01791725|FG001|Participant Flow|ELND005 QD|"ELND005 250 mg QD~ELND005"
11136385|NCT01791725|FG002|Participant Flow|Placebo|"Placebo BID~Placebo"
11136386|NCT01791725|OG000|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
11136387|NCT01791725|OG001|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
11136388|NCT01791725|OG002|Outcome|Placebo|"Placebo BID~Placebo"
11136389|NCT01791725|EG000|Reported Event|ELND005 BID|"ELND005 250 mg BID~ELND005"
11136390|NCT01791725|EG001|Reported Event|ELND005 QD|"ELND005 250 mg QD~ELND005"
11136391|NCT01791725|EG002|Reported Event|Placebo|"Placebo BID~Placebo"
11136392|NCT01791803|BG000|Baseline|Hypnotherapy|Patients received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use . They also received counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.
11136393|NCT01791803|BG001|Baseline|Nicotine Replacement Therapy|Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays, self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.
11136394|NCT01791803|BG002|Baseline|Hypnotherapy and Nicotine Replacement|patients recieved both a similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.
11136395|NCT01791803|BG003|Baseline|Self-Quit Group|Patients were given brief counseling during hospitalization and were not contacted until 26 weeks after hospitalization. They received no telephone contact and or counseling after discharge.
11136396|NCT01791803|BG004|Baseline|Total|Total of all reporting groups
11136397|NCT01791803|FG000|Participant Flow|Hypnotherapy|"Patients admitted with a cardiopulmonary illness will receive a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
11136398|NCT01791803|FG001|Participant Flow|Nicotine Replacement Therapy|"Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.~Nicotine: free one month supply after hospital discharge"
11136399|NCT01791803|FG002|Participant Flow|Hypnotherapy and Nicotine Replacement|"The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge~Nicotine: free one month supply after hospital discharge"
11136400|NCT01791803|FG003|Participant Flow|Self-Quit Group|patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
11136401|NCT01791803|OG000|Outcome|Hypnotherapy|"Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
11136402|NCT01791803|OG001|Outcome|Nicotine Replacement Therapy|"Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.~Nicotine: free one month supply after hospital discharge"
11136403|NCT01791803|OG002|Outcome|Hypnotherapy and Nicotine Replacement|"The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge~Nicotine: free one month supply after hospital discharge"
11136404|NCT01791803|OG003|Outcome|Self-Quit Group|patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
11136405|NCT01791803|OG000|Outcome|Hypnotherapy|"Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
11136406|NCT01791803|OG003|Outcome|Self-Quit Group|patients were given brief counseling during hospitalization and were not be contacted until 26 weeks after hospitalization.
11136407|NCT01791803|OG000|Outcome|Smoking Abstinence Rates at 12 and 26 Weeks|Smoking status at follow-up time at 12 and 26 weeks by diagnosis status (cardiac vs. pulmonary)
11136408|NCT01791803|EG000|Reported Event|Hypnotherapy|patients receiving a free intensive session of hypnotherapy within 2 weeks of hospitalization
11136409|NCT01791803|EG001|Reported Event|Nicotine Replacement Therapy|Patients receiving a free months supply of nicotine
11136410|NCT01791803|EG002|Reported Event|Hypnotherapy and Nicotine Replacement|Patients receiving hypnotherapy and nicotine supply
11136411|NCT01791803|EG003|Reported Event|Self-Quit Group|patient who decided to quit on their own
11136412|NCT01791894|BG000|Baseline|Treatment (Arsenic Trioxide)|arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days
11136413|NCT01791894|FG000|Participant Flow|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
11136414|NCT01791894|OG000|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV~laboratory biomarker analysis: Correlative studies"
11136415|NCT01791894|OG000|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
11136416|NCT01791894|EG000|Reported Event|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV"
11136417|NCT01791972|BG000|Baseline|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
11136418|NCT01791972|BG001|Baseline|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
11136419|NCT01791972|BG002|Baseline|Total|Total of all reporting groups
11136420|NCT01791972|FG000|Participant Flow|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
11136421|NCT01791972|FG001|Participant Flow|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
11136422|NCT01791972|OG000|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
11136423|NCT01791972|OG001|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
11136424|NCT01791972|EG000|Reported Event|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
11136425|NCT01791972|EG001|Reported Event|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
11136426|NCT01792024|BG000|Baseline|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
11136427|NCT01792024|FG000|Participant Flow|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
11136428|NCT01792024|OG000|Outcome|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
11136429|NCT01792024|EG000|Reported Event|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
11136430|NCT01792115|BG000|Baseline|Vit E 200 IU/d|"Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.~Vitamin E 200 IU/d: Supplement-low dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136431|NCT01792115|BG001|Baseline|Vitamin E 400|"Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.~Vitamin E 400 IU/d: Supplement-intermediate dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136432|NCT01792115|BG002|Baseline|Vitamin E 800|"Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.~Vitamin E 800 IU/d: Supplement High Dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136433|NCT01792115|BG003|Baseline|Total|Total of all reporting groups
11136434|NCT01792115|FG000|Participant Flow|Vit E 200 IU/d|"Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.~Vitamin E 200 IU/d: Supplement-low dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136435|NCT01792115|FG001|Participant Flow|Vitamin E 400|"Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.~Vitamin E 400 IU/d: Supplement-intermediate dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136436|NCT01792115|FG002|Participant Flow|Vitamin E 800|"Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.~Vitamin E 800 IU/d: Supplement High Dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136437|NCT01792115|OG000|Outcome|Vit E 200 IU/d|"Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.~Vitamin E 200 IU/d: Supplement-low dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136438|NCT01792115|OG001|Outcome|Vitamin E 400|"Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.~Vitamin E 400 IU/d: Supplement-intermediate dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136439|NCT01792115|OG002|Outcome|Vitamin E 800|"Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.~Vitamin E 800 IU/d: Supplement High Dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136440|NCT01792115|EG000|Reported Event|Vit E 200 IU/d|"Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.~Vitamin E 200 IU/d: Supplement-low dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136441|NCT01792115|EG001|Reported Event|Vitamin E 400|"Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.~Vitamin E 400 IU/d: Supplement-intermediate dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11149693|NCT01872611|EG003|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
11136442|NCT01792115|EG002|Reported Event|Vitamin E 800|"Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.~Vitamin E 800 IU/d: Supplement High Dose~Diet and Exercise: Diet and Exercise for all Arms of the study at baseline"
11136443|NCT01792284|BG000|Baseline|All Enrolled Participants|"Participants entered a 12-week Lead-in Period where they received fixed time of dose of LY2605541 with bolus insulin lispro. Participants were then randomized to either a fixed time of dose or a variable time of dose regimen for 12 weeks administered with bolus insulin lispro; after 12 weeks, they crossed over to the alternate regimen. LY2605541 dose was adjusted using a dosing algorithm based on the participant's BG values and documented hypoglycemia during the previous week. Insulin dose were determined by insulin algorithms based on SMBG.~Fixed time of dose: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks administered with bolus insulin lispro.~Variable time of dose: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks administered with bolus insulin lispro."
11136444|NCT01792284|FG000|Participant Flow|LY2605541 Fixed Time Dosing (All Participants)|"Lead-in Period: Participant-specific dose of LY2605541 administered subcutaneously (SQ) at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on self-monitored blood glucose (SMBG).~Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 milligrams/deciliter (mg/dL) Insulin adjustment and glucose correction between 71 and 100 mg/dL."
11136445|NCT01792284|FG001|Participant Flow|LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing|"Randomization Period 1: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Randomization Period 2: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL."
11136446|NCT01792284|FG002|Participant Flow|LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing|"Randomization Period 1: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Randomization Period 2: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL."
11136447|NCT01792284|OG000|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
11136448|NCT01792284|OG001|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
11136449|NCT01792284|OG000|Outcome|All Participants|"All enrolled participants entered a 12-week lead-in period where they received fixed time dosing of LY2605541. Participants were then randomized to a fixed evening dose regimen or a variable time dose regimen for 12 weeks; after 12 weeks, they crossed over to the alternate regimen.~Fixed-time dose regimen: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.~Variable-time dose regimen: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks."
11136450|NCT01792284|EG000|Reported Event|LY2605541 (All Participants)|All participants who received at least 1 dose of LY2605541 during the Lead-In Period, Randomization Period 1, and Randomization Period 2.
11136451|NCT01792284|EG001|Reported Event|LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing|"Randomization Period 1: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Randomization Period 2: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL."
11136452|NCT01792284|EG002|Reported Event|LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing|"Randomization Period 1: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Randomization Period 2: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL."
11136453|NCT01792518|BG000|Baseline|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
11136454|NCT01792518|BG001|Baseline|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
11136455|NCT01792518|BG002|Baseline|Total|Total of all reporting groups
11136456|NCT01792518|FG000|Participant Flow|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
11136457|NCT01792518|FG001|Participant Flow|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
11136458|NCT01792518|OG000|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
11136459|NCT01792518|OG001|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
11136460|NCT01792518|EG000|Reported Event|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
11136461|NCT01792518|EG001|Reported Event|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
11136462|NCT01792635|BG000|Baseline|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
11136463|NCT01792635|BG001|Baseline|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136464|NCT01792635|BG002|Baseline|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136465|NCT01792635|BG003|Baseline|Total|Total of all reporting groups
11136466|NCT01792635|FG000|Participant Flow|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
11136467|NCT01792635|FG001|Participant Flow|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136468|NCT01792635|FG002|Participant Flow|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136469|NCT01792635|OG000|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
11136470|NCT01792635|OG000|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136471|NCT01792635|OG000|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136472|NCT01792635|OG001|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136473|NCT01792635|EG000|Reported Event|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
11136474|NCT01792635|EG001|Reported Event|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136475|NCT01792635|EG002|Reported Event|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
11136476|NCT01792817|BG000|Baseline|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
11136477|NCT01792817|BG001|Baseline|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
11136478|NCT01792817|BG002|Baseline|Total|Total of all reporting groups
11136479|NCT01792817|FG000|Participant Flow|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
11136480|NCT01792817|FG001|Participant Flow|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
11136481|NCT01792817|FG002|Participant Flow|GammaCore Open Label|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
11136482|NCT01792817|OG000|Outcome|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
11136483|NCT01792817|OG001|Outcome|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
11136484|NCT01792817|EG000|Reported Event|Sham GammaCore Device (Randomized Period)|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
11136485|NCT01792817|EG001|Reported Event|GammaCore Device (Randomized Period)|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
11136486|NCT01792817|EG002|Reported Event|GammaCore Device (Open Label Period)|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
11136487|NCT01792830|BG000|Baseline|Control, Non-diabetic, no Treatment|Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C <7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.
11136488|NCT01792830|BG001|Baseline|Non-diabetic, Metformin|Participants without a history of diabetes and with HbA1C <7%, who were discharged on oral metformin following CABG surgery.
11136489|NCT01792830|BG002|Baseline|Non-diabetic, Insulin|Participants without a history of diabetes and with HbA1C< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.
11136490|NCT01792830|BG003|Baseline|Diabetic, HbA1C <7%, Metformin|Participants with a history of diabetes and with HbA1C <7% who were discharged on oral metformin, following CABG surgery.
11136491|NCT01792830|BG004|Baseline|Diabetic, HbA1C <7%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on metformin and insulin glargine, following CABG surgery.
11136492|NCT01792830|BG005|Baseline|Diabetic, HbA1C <7%, Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136493|NCT01792830|BG006|Baseline|Diabetic, HbA1C 7%- 9%, Metformin|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.
11136494|NCT01792830|BG007|Baseline|Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.
11136495|NCT01792830|BG008|Baseline|Diabetic, HbA1C 7%-9%, Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136496|NCT01792830|BG009|Baseline|Diabetic, HbA1C >9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C >9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.
11136497|NCT01792830|BG010|Baseline|Diabetic, HbA1C >9%, Insulin Glulisine|Participants with a history of diabetes and with HbA1C >9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
11136498|NCT01792830|BG011|Baseline|Total|Total of all reporting groups
11136499|NCT01792830|FG000|Participant Flow|Control, Non-diabetic, no Treatment|Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C <7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.
11136500|NCT01792830|FG001|Participant Flow|Non-diabetic, Metformin|Participants without a history of diabetes and with HbA1C <7%, who were discharged on oral metformin following CABG surgery.
11136501|NCT01792830|FG002|Participant Flow|Non-diabetic, Insulin|Participants without a history of diabetes and with HbA1C< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.
11136502|NCT01792830|FG003|Participant Flow|Diabetic, HbA1C <7%, Metformin|Participants with a history of diabetes and with HbA1C <7% who were discharged on oral metformin, following CABG surgery.
11136503|NCT01792830|FG004|Participant Flow|Diabetic, HbA1C <7%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on metformin and insulin glargine, following CABG surgery.
11136504|NCT01792830|FG005|Participant Flow|Diabetic, HbA1C <7%, Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136505|NCT01792830|FG006|Participant Flow|Diabetic, HbA1C 7%- 9%, Metformin|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.
11136506|NCT01792830|FG007|Participant Flow|Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.
11136507|NCT01792830|FG008|Participant Flow|Diabetic, HbA1C 7%-9%, Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136508|NCT01792830|FG009|Participant Flow|Diabetic, HbA1C >9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C >9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.
11136509|NCT01792830|FG010|Participant Flow|Diabetic, HbA1C >9%, Insulin Glulisine|Participants with a history of diabetes and with HbA1C >9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
11136510|NCT01792830|OG000|Outcome|Control, Non-diabetic, no Treatment|Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C <7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.
11136511|NCT01792830|OG001|Outcome|Non-diabetic, Metformin|Participants without a history of diabetes and with HbA1C <7%, who were discharged on oral metformin following CABG surgery.
11136512|NCT01792830|OG002|Outcome|Non-diabetic, Insulin|Participants without a history of diabetes and with HbA1C< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.
11136513|NCT01792830|OG003|Outcome|Diabetic, HbA1C <7%, Metformin|Participants with a history of diabetes and with HbA1C <7% who were discharged on oral metformin, following CABG surgery.
11136514|NCT01792830|OG004|Outcome|Diabetic, HbA1C <7%, Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136515|NCT01792830|OG005|Outcome|Diabetic, HbA1C 7%- 9%, Metformin|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.
11136516|NCT01792830|OG006|Outcome|Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.
11136517|NCT01792830|OG007|Outcome|Diabetic, HbA1C 7%-9%, Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136518|NCT01792830|OG008|Outcome|Diabetic, HbA1C >9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C >9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.
11136519|NCT01792830|OG009|Outcome|Diabetic, HbA1C >9%, Insulin Glulisine|Participants with a history of diabetes and with HbA1C >9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
11136520|NCT01792830|OG004|Outcome|Diabetic, HbA1C <7%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on metformin and insulin glargine, following CABG surgery.
11136521|NCT01792830|OG005|Outcome|Diabetic, HbA1C <7%, Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136522|NCT01792830|OG006|Outcome|Diabetic, HbA1C 7%- 9%, Metformin|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.
11136523|NCT01792830|OG007|Outcome|Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.
11136524|NCT01792830|OG008|Outcome|Diabetic, HbA1C 7%-9%, Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136525|NCT01792830|OG009|Outcome|Diabetic, HbA1C >9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C >9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.
11136526|NCT01792830|OG010|Outcome|Diabetic, HbA1C >9%, Insulin Glulisine|Participants with a history of diabetes and with HbA1C >9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
11136527|NCT01792830|EG000|Reported Event|Control, Non-diabetic, no Treatment|Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C <7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.
11136528|NCT01792830|EG001|Reported Event|Non-diabetic, Metformin|Participants without a history of diabetes and with HbA1C <7%, who were discharged on oral metformin following CABG surgery.
11136529|NCT01792830|EG002|Reported Event|Non-diabetic, Insulin|Participants without a history of diabetes and with HbA1C< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.
11136530|NCT01792830|EG003|Reported Event|Diabetic, HbA1C <7%, Metformin|Participants with a history of diabetes and with HbA1C <7% who were discharged on oral metformin, following CABG surgery.
11136531|NCT01792830|EG004|Reported Event|Diabetic, HbA1C <7%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on metformin and insulin glargine, following CABG surgery.
11136532|NCT01792830|EG005|Reported Event|Diabetic, HbA1C <7%, Insulin Glargine|Participants with a history of diabetes and with HbA1C <7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136533|NCT01792830|EG006|Reported Event|Diabetic, HbA1C 7%- 9%, Metformin|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.
11136534|NCT01792830|EG007|Reported Event|Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.
11136535|NCT01792830|EG008|Reported Event|Diabetic, HbA1C 7%-9%, Insulin Glargine|Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.
11136536|NCT01792830|EG009|Reported Event|Diabetic, HbA1C >9%, Metformin and Insulin Glargine|Participants with a history of diabetes and with HbA1C >9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.
11136537|NCT01792830|EG010|Reported Event|Diabetic, HbA1C >9%, Insulin Glulisine|Participants with a history of diabetes and with HbA1C >9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
11136538|NCT01792986|BG000|Baseline|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
11136539|NCT01792986|FG000|Participant Flow|Water-only 24-hour Fasting Once Per Week for 6 Weeks|water-only 24-hour fasting once per week for 6 weeks
11136540|NCT01792986|OG000|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
11136541|NCT01792986|EG000|Reported Event|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
11136542|NCT01793051|BG000|Baseline|Minocycline|Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
11136543|NCT01793051|BG001|Baseline|Placebo|Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
11136544|NCT01793051|BG002|Baseline|Total|Total of all reporting groups
11136545|NCT01793051|FG000|Participant Flow|Minocycline|Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
11136546|NCT01793051|FG001|Participant Flow|Placebo|Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
11136547|NCT01793051|OG000|Outcome|Minocycline|Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
11136548|NCT01793051|OG001|Outcome|Placebo|Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
11136549|NCT01793051|EG000|Reported Event|Minocycline|Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
11136550|NCT01793051|EG001|Reported Event|Placebo|Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
11136551|NCT01793142|BG000|Baseline|Viviant Tablet 20 mg|Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
11136552|NCT01793142|FG000|Participant Flow|Viviant Tablet 20 mg|Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
11136553|NCT01793142|OG000|Outcome|Viviant Tablet 20 mg|Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
11136554|NCT01793142|EG000|Reported Event|Viviant Tablet 20 mg|Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
11136555|NCT01793285|BG000|Baseline|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
11136556|NCT01793285|FG000|Participant Flow|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 milligram (mg) weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
11136557|NCT01793285|OG000|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
11136558|NCT01793285|EG000|Reported Event|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
11136559|NCT01793688|BG000|Baseline|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
11136560|NCT01793688|FG000|Participant Flow|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
11136561|NCT01793688|OG000|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
11136562|NCT01793688|EG000|Reported Event|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
11136563|NCT01793792|BG000|Baseline|Device: LVIS|LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
11136564|NCT01793792|FG000|Participant Flow|Device: LVIS|Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
11136565|NCT01793792|OG000|Outcome|Device: LVIS|Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
11136566|NCT01793792|EG000|Reported Event|Device: LVIS|LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
11136567|NCT01793883|BG000|Baseline|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo~40 mg Laninamivir Octanoate~Placebo"
11136568|NCT01793883|BG001|Baseline|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir~80 mg Laninamivir Octanoate"
11136569|NCT01793883|BG002|Baseline|Placebo|"Matching Placebo~Placebo"
11136570|NCT01793883|BG003|Baseline|Total|Total of all reporting groups
11136571|NCT01793883|FG000|Participant Flow|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo~40 mg Laninamivir Octanoate~Placebo"
11136572|NCT01793883|FG001|Participant Flow|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir~80 mg Laninamivir Octanoate"
11136573|NCT01793883|FG002|Participant Flow|Placebo|"Matching Placebo~Placebo"
11136574|NCT01793883|OG000|Outcome|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo~40 mg Laninamivir Octanoate~Placebo"
11136575|NCT01793883|OG001|Outcome|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir~80 mg Laninamivir Octanoate"
11136576|NCT01793883|OG002|Outcome|Placebo|"Matching Placebo~Placebo"
11136577|NCT01793883|EG000|Reported Event|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo~40 mg Laninamivir Octanoate~Placebo"
11136578|NCT01793883|EG001|Reported Event|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir Octanoate~80 mg Laninamivir Octanoate"
11136579|NCT01793883|EG002|Reported Event|Placebo|"Matching Placebo~Placebo"
11136580|NCT01793909|BG000|Baseline|Type 2 Diabetes|Individuals with a diagnosis of type 2 diabetes
11136581|NCT01793909|BG001|Baseline|Overweight Controls|Individuals with a BMI 25-30 but otherwise healthy.
11136582|NCT01793909|BG002|Baseline|Total|Total of all reporting groups
11136583|NCT01793909|FG000|Participant Flow|Type 2 Diabetes|Individuals with a diagnosis of type 2 diabetes
11136584|NCT01793909|FG001|Participant Flow|Overweight Controls|Individuals with a BMI 25-30 but otherwise healthy.
11136585|NCT01793909|OG000|Outcome|Type 2 Diabetes|Individuals with a diagnosis of type 2 diabetes
11136586|NCT01793909|OG001|Outcome|Overweight Controls|Individuals with a BMI 25-30 but otherwise healthy.
11136587|NCT01793909|EG000|Reported Event|Type 2 Diabetes|Individuals with a diagnosis of type 2 diabetes
11136588|NCT01793909|EG001|Reported Event|Overweight Controls|Individuals with a BMI 25-30 but otherwise healthy.
11136589|NCT01793935|BG000|Baseline|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
11136590|NCT01793935|BG001|Baseline|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
11136591|NCT01793935|BG002|Baseline|Total|Total of all reporting groups
11136592|NCT01793935|FG000|Participant Flow|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
11136593|NCT01793935|FG001|Participant Flow|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
11136594|NCT01793935|OG000|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
11136595|NCT01793935|OG001|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
11136596|NCT01793935|EG000|Reported Event|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
11136597|NCT01793935|EG001|Reported Event|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
11136598|NCT01794000|BG000|Baseline|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
11136599|NCT01794000|BG001|Baseline|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
11136600|NCT01794000|BG002|Baseline|Total|Total of all reporting groups
11136601|NCT01794000|FG000|Participant Flow|Prasugrel|Participants (Pts.) will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
11136602|NCT01794000|FG001|Participant Flow|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
11136603|NCT01794000|OG000|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
11136604|NCT01794000|OG001|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
11136605|NCT01794000|EG000|Reported Event|Prasugrel - Double Blind Phase|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
11136606|NCT01794000|EG001|Reported Event|Placebo - Double Blind Phase|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
11136607|NCT01794000|EG002|Reported Event|Prasugrel - Open Label Phase|Participants who continued to meet eligibility criteria, who were not permanently discontinued from study drug, and who concluded their participation in 24 months of double blind treatment were to be considered eligible to enter the open label phase.
11136608|NCT01794039|BG000|Baseline|Arm A (Lenalidomide, Dexamethasone)|"Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.> > Dexamethasone: Given PO>~> Lenalidomide: Given PO"
11136609|NCT01794039|BG001|Baseline|Arm B (Pomalidomide, Dexamethasone)|"Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.> > Dexamethasone: Given PO>~> Pomalidomide: Given PO"
11136610|NCT01794039|BG002|Baseline|Total|Total of all reporting groups
11136611|NCT01794039|FG000|Participant Flow|Arm A (Lenalidomide, Dexamethasone)|"Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.> > Dexamethasone: Given PO>~> Lenalidomide: Given PO"
11136612|NCT01794039|FG001|Participant Flow|Arm B (Pomalidomide, Dexamethasone)|"Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.> > Dexamethasone: Given PO>~> Pomalidomide: Given PO"
11136613|NCT01794039|OG000|Outcome|Arm A (Lenalidomide, Dexamethasone)|"Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.~>~> Dexamethasone: Given PO~>~> Lenalidomide: Given PO"
11136614|NCT01794039|OG001|Outcome|Arm B (Pomalidomide, Dexamethasone)|"Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~>~> Dexamethasone: Given PO~>~> Pomalidomide: Given PO"
11136615|NCT01794039|OG000|Outcome|Arms A and B|4 arm A patients were transferred to Arm B for further treatment. Arm A patients, that went off study for any reason, were allowed to transfer to Arm B.
10887376|NCT00500266|BG000|Baseline|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
11136616|NCT01794039|OG000|Outcome|Arms A and B|4 arm A patients were transferred to Arm B for further treatment. Arm A patients, that went off study for any reason, were allowed to transfer to Arm B
11136617|NCT01794039|EG000|Reported Event|Arm A (Lenalidomide, Dexamethasone)|Lenalidomide: Given PO
11136618|NCT01794039|EG001|Reported Event|Arm B (Pomalidomide, Dexamethasone)|Pomalidomide: Given PO
11136619|NCT01794117|BG000|Baseline|Week 4 Level 1 Only|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
11136620|NCT01794117|BG001|Baseline|Week 4 Level 1 Followed by Week 8 Level 2|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
11136621|NCT01794117|BG002|Baseline|Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
11136622|NCT01794117|BG003|Baseline|Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
11136623|NCT01794117|BG004|Baseline|Total|Total of all reporting groups
11136624|NCT01794117|FG000|Participant Flow|Week 4 Level 1 Only|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
11136625|NCT01794117|FG001|Participant Flow|Week 4 Level 1 Followed by Week 8 Level 2|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
11136626|NCT01794117|FG002|Participant Flow|Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
11136627|NCT01794117|FG003|Participant Flow|Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
11136628|NCT01794117|OG000|Outcome|All Participants|All participants that received Anakinra 100mg, 200mg, and 300mg administered subcutaneously daily for 12 weeks.
11136629|NCT01794117|OG000|Outcome|Week 4 Level 1 Only|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
11136630|NCT01794117|OG001|Outcome|Week 4 Level 1 Followed by Week 8 Level 2|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
11136631|NCT01794117|OG002|Outcome|Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
11136632|NCT01794117|OG003|Outcome|Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
11136633|NCT01794117|EG000|Reported Event|Week 4 Level 1 Only|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
11136634|NCT01794117|EG001|Reported Event|Week 4 Level 1 Followed by Week 8 Level 2|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
11136635|NCT01794117|EG002|Reported Event|Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
11136636|NCT01794117|EG003|Reported Event|Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3|Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
11136637|NCT01794299|BG000|Baseline|ATIR|ATIR: Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.
11136638|NCT01794299|FG000|Participant Flow|ATIR|ATIR: Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.
11136639|NCT01794299|OG000|Outcome|ATIR|ATIR: Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.
11136640|NCT01794299|EG000|Reported Event|ATIR|ATIR: Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.
11136641|NCT01794312|BG000|Baseline|T4020|One drop every 2 days
11136642|NCT01794312|BG001|Baseline|Vehicle|One drop every 2 days
11136643|NCT01794312|BG002|Baseline|Total|Total of all reporting groups
11136644|NCT01794312|FG000|Participant Flow|T4020|One drop every 2 days
11136645|NCT01794312|FG001|Participant Flow|Vehicle|One drop every 2 days
11136646|NCT01794312|OG000|Outcome|T4020|One drop every 2 days
11136647|NCT01794312|OG001|Outcome|Vehicle|One drop every 2 days
11136648|NCT01794312|EG000|Reported Event|T4020|One drop 4 times per week
11136649|NCT01794312|EG001|Reported Event|Vehicle|One drop 4 times per week
11136650|NCT01794455|BG000|Baseline|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
11136651|NCT01794455|BG001|Baseline|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
11136652|NCT01794455|BG002|Baseline|Total|Total of all reporting groups
11136653|NCT01794455|FG000|Participant Flow|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
11136654|NCT01794455|FG001|Participant Flow|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
11136655|NCT01794455|OG000|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
11136656|NCT01794455|OG001|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
11136657|NCT01794455|EG000|Reported Event|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
11136658|NCT01794455|EG001|Reported Event|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
11136659|NCT01794689|BG000|Baseline|Morphine US Then Morphine FA|Participants randomized to receive Morphine and the Uninterrupted Sleep (US) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of uninterrupted sleep (US). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of forced awakenings (FA). They will receive the Morphine injection (0.08mg/kg) via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the US and FA sleep conditions are completed.
11136660|NCT01794689|BG001|Baseline|Morphine FA Then Morphine US|Participants randomized to receive Morphine and the Forced Awakenings (FA) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of forced awakenings (FA). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of uninterrupted sleep (US). They will receive the Morphine injection (0.08mg/kg) via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the FA and US sleep conditions are completed.
11136661|NCT01794689|BG002|Baseline|Placebo US Then Placebo FA|Participants randomized to receive the saline placebo and the Uninterrupted Sleep (US) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of uninterrupted sleep (US). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of forced awakenings (FA). They will receive the injection via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the US and FA sleep conditions are completed.
11136662|NCT01794689|BG003|Baseline|Placebo FA Then Placebo US|Participants randomized to receive the saline placebo and the Forced Awakenings (FA) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of forced awakenings (FA). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of uninterrupted sleep (US). They will receive the injection via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the FA and US sleep conditions are completed.
11136663|NCT01794689|BG004|Baseline|Total|Total of all reporting groups
11136664|NCT01794689|FG000|Participant Flow|Morphine US Then Morphine FA|Participants randomized to receive Morphine and the Uninterrupted Sleep (US) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of uninterrupted sleep (US). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of forced awakenings (FA). They will receive the Morphine injection (0.08mg/kg) via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the US and FA sleep conditions are completed.
11136665|NCT01794689|FG001|Participant Flow|Morphine FA Then Morphine US|Participants randomized to receive Morphine and the Forced Awakenings (FA) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of forced awakenings (FA). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of uninterrupted sleep (US). They will receive the Morphine injection (0.08mg/kg) via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the FA and US sleep conditions are completed.
11136666|NCT01794689|FG002|Participant Flow|Placebo US Then Placebo FA|Participants randomized to receive the saline placebo and the Uninterrupted Sleep (US) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of uninterrupted sleep (US). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of forced awakenings (FA). They will receive the injection via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the US and FA sleep conditions are completed.
11136667|NCT01794689|FG003|Participant Flow|Placebo FA Then Placebo US|Participants randomized to receive the saline placebo and the Forced Awakenings (FA) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of forced awakenings (FA). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of uninterrupted sleep (US). They will receive the injection via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the FA and US sleep conditions are completed.
11136668|NCT01794689|OG000|Outcome|Morphine US|Participants that received morphine with Uninterrupted sleep (US).
11136669|NCT01794689|OG001|Outcome|Morphine FA|Participants that received morphine with forced awakenings (FA).
11136670|NCT01794689|OG002|Outcome|Placebo US|Participants that received placebo with Uninterrupted sleep (US).
11136671|NCT01794689|OG003|Outcome|Placebo FA|Participants that received placebo with forced awakenings (FA).
11136672|NCT01794689|OG000|Outcome|Morphine US|Participants that received morphine with Uninterrupted Sleep (US).
11136673|NCT01794689|OG002|Outcome|Placebo US|Participants that received placebo with Uninterrupted Sleep (US).
11136674|NCT01794689|OG000|Outcome|Morphine US|Participants randomized to receive Morphine and the Uninterrupted Sleep (US) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of uninterrupted sleep (US). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of forced awakenings (FA). They will receive the Morphine injection (0.08mg/kg) via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the US and FA sleep conditions are completed.
11136675|NCT01794689|OG001|Outcome|Morphine FA|Participants randomized to receive Morphine and the Forced Awakenings (FA) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of forced awakenings (FA). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of uninterrupted sleep (US). They will receive the Morphine injection (0.08mg/kg) via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the FA and US sleep conditions are completed.
11136676|NCT01794689|OG002|Outcome|Placebo US|Participants randomized to receive the saline placebo and the Uninterrupted Sleep (US) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of uninterrupted sleep (US). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of forced awakenings (FA). They will receive the injection via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the US and FA sleep conditions are completed.
11136677|NCT01794689|OG003|Outcome|Placebo FA|Participants randomized to receive the saline placebo and the Forced Awakenings (FA) condition first. After a polysomnography (PSG) screening night, participants were randomized to receive two consecutive nights of forced awakenings (FA). With a minimum of a two week washout period, participants then completed the opposing sleep condition of two nights of uninterrupted sleep (US). They will receive the injection via IV bolus over 30 seconds during each experimental quantitative sensory testing session that occurs after the FA and US sleep conditions are completed.
11136678|NCT01794689|EG000|Reported Event|Morphine US|Participants that received morphine with Uninterrupted sleep (US).
11136679|NCT01794689|EG001|Reported Event|Morphine FA|Participants that received morphine with forced awakenings (FA).
11136680|NCT01794689|EG002|Reported Event|Placebo US|Participants that received placebo with Uninterrupted sleep (US).
11136681|NCT01794689|EG003|Reported Event|Placebo FA|Participants that received placebo with forced awakenings (FA).
11136682|NCT01794702|BG000|Baseline|Period 1|"Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin~Phase I - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Clofarabine: Phase I Starting Dose - 15 mg/m^2 by vein daily for 4 days (days 6-9)"
11136683|NCT01794702|BG001|Baseline|Period 2|"Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin~Phase I - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Clofarabine: Phase I Dose -1 - 15 mg/m^2 by vein daily for 3 days (days 6-9)"
11136684|NCT01794702|BG002|Baseline|Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin|"Phase II - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9)."
11136685|NCT01794702|BG003|Baseline|Total|Total of all reporting groups
11136686|NCT01794702|FG000|Participant Flow|Period 1|"Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin~Phase I - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Clofarabine: Phase I Starting Dose - 15 mg/m^2 by vein daily for 4 days (days 6-9)"
11136687|NCT01794702|FG001|Participant Flow|Period 2|"Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin~Phase I - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Clofarabine: Phase I Dose level -1 - 15 mg/m^2 by vein daily for 3 days (days 6-9)"
11136688|NCT01794702|FG002|Participant Flow|Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin|"Phase II - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Phase II - Clofarabine 15 mg/m^2 by vein over approximately 1 hour for 4 days (days 6-9)."
11136689|NCT01794702|OG000|Outcome|Period 1|"Clofarabine + Cytarabine + Decitabine + Idarubicin~Phase I - Decitabine 20 mg/m^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein over approximately 2 hours daily for 5 days (days 6-10)~Clofarabine 15 mg/m^2 by vein over approximately 1 hour daily"
11136690|NCT01794702|OG001|Outcome|Period 2|"Clofarabine + Cytarabine + Decitabine + Idarubicin~Phase I - Decitabine 20 mg/m^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein over approximately 2 hours daily for 5 days (days 6-10)~Clofarabine 15 mg/m^2 by vein over approximately 1 hour daily"
11136691|NCT01794702|OG000|Outcome|Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin|"Phase II - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9)."
11136692|NCT01794702|EG000|Reported Event|Period 1|"Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin~Phase I - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Clofarabine: Phase I Starting Dose - 15 mg/m^2 by vein daily for 4 days (days 6-9)"
11136693|NCT01794702|EG001|Reported Event|Period 2|"Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin~Phase I - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Clofarabine: Phase I Dose level -1 - 15 mg/m^2 by vein daily for 3 days (days 6-9)"
11136694|NCT01794702|EG002|Reported Event|Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin|"Phase II - Decitabine 20 mg/m^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m^2 by vein for approximately 2 hours daily for 5 days (days 6-10)~Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9)."
11136695|NCT01794741|BG000|Baseline|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
11136696|NCT01794741|BG001|Baseline|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
11136697|NCT01794741|BG002|Baseline|Total|Total of all reporting groups
11136698|NCT01794741|FG000|Participant Flow|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
11136699|NCT01794741|FG001|Participant Flow|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
11136700|NCT01794741|OG000|Outcome|Dymista Nasal Spray|
11136701|NCT01794741|OG001|Outcome|Fluticasone Nasal Spray|
11136702|NCT01794741|EG000|Reported Event|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
11136703|NCT01794741|EG001|Reported Event|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
11136704|NCT01794780|BG000|Baseline|Indacaterol|LABA: Indacaterol, once a day, 150μg each time
11136705|NCT01794780|BG001|Baseline|Tiotropium Bromide|LAMA: Tiotropium Bromide, once a day, 18 μg
11136706|NCT01794780|BG002|Baseline|Salmeterol/Fluticasone|LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
11136707|NCT01794780|BG003|Baseline|Budesonide/ Formoterol|Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
11136708|NCT01794780|BG004|Baseline|Indacaterol +Tiotropium|Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
11136709|NCT01794780|BG005|Baseline|LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium|Salmeterol / fluticasone Or budesonide / formoterol
11136710|NCT01794780|BG006|Baseline|Oral Theophylline|Oral theophylline
11136711|NCT01794780|BG007|Baseline|Other Treatment|
11136712|NCT01794780|BG008|Baseline|Total|Total of all reporting groups
11136713|NCT01794780|FG000|Participant Flow|Indacaterol|LABA: Indacaterol, once a day, 150μg each time
11136714|NCT01794780|FG001|Participant Flow|Tiotropium Bromide|LAMA: Tiotropium Bromide, once a day, 18 μg
11136715|NCT01794780|FG002|Participant Flow|Salmeterol/Fluticasone|LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
11136716|NCT01794780|FG003|Participant Flow|Budesonide/ Formoterol|Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
11136717|NCT01794780|FG004|Participant Flow|Indacaterol +Tiotropium|Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
11136718|NCT01794780|FG005|Participant Flow|LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium|Salmeterol / fluticasone Or budesonide / formoterol
11136719|NCT01794780|FG006|Participant Flow|Oral Theophylline|Oral theophylline
11136720|NCT01794780|FG007|Participant Flow|Other Treatment|
11136721|NCT01794780|OG000|Outcome|Indacaterol|LABA: Indacaterol, once a day, 150μg each time
11136722|NCT01794780|OG001|Outcome|Tiotropium|LAMA: Tiotropium Bromide, once a day, 18 μg
11136723|NCT01794780|OG002|Outcome|LABA/ICS|Salmeterol / fluticasone Or budesonide / formoterol
11136724|NCT01794780|OG003|Outcome|Indacaterol + Tiotropium|Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
11136725|NCT01794780|OG004|Outcome|LABA/ICS + Tiotropium|(Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium
11136726|NCT01794780|OG005|Outcome|Oral Theophylline|Oral theophylline
11136727|NCT01794780|OG001|Outcome|Tiotropium Bromide|LAMA: Tiotropium Bromide, once a day, 18 μg
11136728|NCT01794780|OG003|Outcome|Indacaterol +Tiotropium|Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
11136729|NCT01794780|OG002|Outcome|Salmeterol/Fluticasone|LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
11136730|NCT01794780|OG003|Outcome|Budesonide/ Formoterol|Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
11136731|NCT01794780|OG004|Outcome|LABA/ICS|Salmeterol / fluticasone Or budesonide / formoterol
11136732|NCT01794780|OG005|Outcome|Indacaterol +Tiotropium|Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
11136733|NCT01794780|OG006|Outcome|LABA/ICS + Tiotropium|(Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium
11136734|NCT01794780|OG007|Outcome|Oral Theophylline|Oral theophylline
11136735|NCT01794780|OG004|Outcome|LABA/ICS + Tiotropium|Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium
11136736|NCT01794780|EG000|Reported Event|Indacaterol|Indacaterol
11136737|NCT01794780|EG001|Reported Event|Tiotropium|Tiotropium
11136738|NCT01794780|EG002|Reported Event|Salemeterol/Fluticasone|Salemeterol/Fluticasone
11136739|NCT01794780|EG003|Reported Event|Budesonide/Formoterol|Budesonide/Formoterol
11136740|NCT01794780|EG004|Reported Event|Indacaterol + Tiotropium|Indacaterol + Tiotropium
11136741|NCT01794780|EG005|Reported Event|Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium|Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium
11136742|NCT01794780|EG006|Reported Event|Oral Theophylline|Oral Theophylline
11136743|NCT01794780|EG007|Reported Event|Other|Other
11136744|NCT01794806|BG000|Baseline|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
11136745|NCT01794806|BG001|Baseline|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
11136746|NCT01794806|BG002|Baseline|Total|Total of all reporting groups
11136747|NCT01794806|FG000|Participant Flow|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
11136748|NCT01794806|FG001|Participant Flow|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
11136749|NCT01794806|OG000|Outcome|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
11136750|NCT01794806|OG001|Outcome|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
11136751|NCT01794806|EG000|Reported Event|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
11136752|NCT01794806|EG001|Reported Event|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
11136753|NCT01794845|BG000|Baseline|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
11136754|NCT01794845|FG000|Participant Flow|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
11136755|NCT01794845|OG000|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
11136756|NCT01794845|EG000|Reported Event|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
11136757|NCT01794923|BG000|Baseline|Placebo Combined|Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
11136758|NCT01794923|BG001|Baseline|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
11136759|NCT01794923|BG002|Baseline|Ibuprofen Three Times Daily|Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
11136760|NCT01794923|BG003|Baseline|Total|Total of all reporting groups
11136761|NCT01794923|FG000|Participant Flow|Placebo Combined|Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
11136762|NCT01794923|FG001|Participant Flow|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
11136763|NCT01794923|FG002|Participant Flow|Ibuprofen Three Times Daily|Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
11136764|NCT01794923|OG000|Outcome|Placebo Combined|Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
11136765|NCT01794923|OG001|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
11136766|NCT01794923|OG002|Outcome|Ibuprofen Three Times Daily|Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
11136767|NCT01794923|EG000|Reported Event|Placebo Combined|Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
11136768|NCT01794923|EG001|Reported Event|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
11136769|NCT01794923|EG002|Reported Event|Ibuprofen Three Times Daily|Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
11136770|NCT01794949|BG000|Baseline|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
11136771|NCT01794949|BG001|Baseline|NIDDM Patients Receiving the Resolute Stent|Non-insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
11136772|NCT01794949|BG002|Baseline|Total|Total of all reporting groups
11136773|NCT01794949|FG000|Participant Flow|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
11136774|NCT01794949|FG001|Participant Flow|NIDDM Patients Receiving the Resolute Stent|Non-insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
11136775|NCT01794949|OG000|Outcome|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
11136776|NCT01794949|OG001|Outcome|NIDDM Patients Receiving the Resolute Stent|Non-insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
11136777|NCT01794949|EG000|Reported Event|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
11136778|NCT01794949|EG001|Reported Event|NIDDM Patients Receiving the Resolute Stent|Non-insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
11136779|NCT01795079|BG000|Baseline|Active tDCS|"Subjects will undergo 20 minutes active tDCS.~Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session."
11136780|NCT01795079|BG001|Baseline|Sham tDCS|"Subjects will undergo 20 minutes of sham stimulation.~Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session."
11136781|NCT01795079|BG002|Baseline|Total|Total of all reporting groups
11136782|NCT01795079|FG000|Participant Flow|Active tDCS|"Subjects will undergo 20 minutes active tDCS.~Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session."
11136783|NCT01795079|FG001|Participant Flow|Sham tDCS|"Subjects will undergo 20 minutes of sham stimulation.~Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session."
11136784|NCT01795079|OG000|Outcome|Active tDCS|"Subjects will undergo 20 minutes active tDCS.~Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session."
11136785|NCT01795079|OG001|Outcome|Sham tDCS|"Subjects will undergo 20 minutes of sham stimulation.~Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session."
11136786|NCT01795079|EG000|Reported Event|Active tDCS|"Subjects will undergo 20 minutes active tDCS.~Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session."
11136787|NCT01795079|EG001|Reported Event|Sham tDCS|"Subjects will undergo 20 minutes of sham stimulation.~Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session."
11136788|NCT01795105|BG000|Baseline|Aripiprazole (Abilify® Tablets/Abilify® ODT)|Pediatric patients with Tourette syndrome aged 6-18 years who were administered with Aripiprazole (Abilify® Tablets/Abilify® ODT) according to the approved dosage.
11136789|NCT01795105|FG000|Participant Flow|Aripiprazole (Abilify® Tablets/Abilify® ODT)|"Pediatric patients 6 to 18 years of age with Tourette's Disorder~Patients who are prescribed Abilify® Tablets/Abilify® ODT treatment as per investigator's medical judgment.~Dose: Aripiprazole (Abilify® Tablets 2mg, 5mg, 10mg, 15mg, Abilify® ODT 10mg, 15mg)"
11136790|NCT01795105|OG000|Outcome|Aripiprazole Main Surveillance|Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer.
11136791|NCT01795105|OG001|Outcome|Aripiprazole Long-term Surveillance|Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.
11136792|NCT01795105|EG000|Reported Event|Aripiprazole (Abilify® Tablets/Abilify® ODT)|
11136793|NCT01795495|BG000|Baseline|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
11136794|NCT01795495|BG001|Baseline|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
11136795|NCT01795495|BG002|Baseline|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
11136796|NCT01795495|BG003|Baseline|Total|Total of all reporting groups
11136797|NCT01795495|FG000|Participant Flow|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
11136798|NCT01795495|FG001|Participant Flow|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
11136799|NCT01795495|FG002|Participant Flow|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
11136800|NCT01795495|OG000|Outcome|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
11136801|NCT01795495|OG001|Outcome|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
11136802|NCT01795495|OG002|Outcome|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
11136803|NCT01795495|EG000|Reported Event|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
11136804|NCT01795495|EG001|Reported Event|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
11136805|NCT01795495|EG002|Reported Event|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
11136806|NCT01795534|BG000|Baseline|All Participants|Includes groups randomized to receive beetroot shot first and placebo first.
11136807|NCT01795534|FG000|Participant Flow|Beetroot Shot Then Placebo Shot|"Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).~Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)"
11136808|NCT01795534|FG001|Participant Flow|Placebo Shot Then Beetroot Shot|"Intervention: participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)~Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
11136809|NCT01795534|OG000|Outcome|Beetroot Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
11136810|NCT01795534|OG001|Outcome|Placebo Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)."
11136811|NCT01795534|EG000|Reported Event|Beetroot Shot|Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).
11136812|NCT01795534|EG001|Reported Event|Placebo Shot|Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK).
11136813|NCT01795547|BG000|Baseline|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
11136814|NCT01795547|BG001|Baseline|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
11136815|NCT01795547|BG002|Baseline|Total|Total of all reporting groups
11136816|NCT01795547|FG000|Participant Flow|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
11136817|NCT01795547|FG001|Participant Flow|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
11136818|NCT01795547|OG000|Outcome|Aripiprazole|Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
11136819|NCT01795547|OG001|Outcome|Paliperidone|Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
11136820|NCT01795547|OG000|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
11136821|NCT01795547|OG001|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
11136822|NCT01795547|EG000|Reported Event|ARIPIPRAZOLE|Safety data is based on all patients who received study medicine.
11136823|NCT01795547|EG001|Reported Event|PALIPERIDONE|Safety data is based on all patients who received study medicine.
11136824|NCT01795638|BG000|Baseline|Sodium Chloride|"Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously.~Sodium chloride"
11136825|NCT01795638|BG001|Baseline|Sterile Water|"Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously.~Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35."
11136826|NCT01795638|BG002|Baseline|Total|Total of all reporting groups
11136827|NCT01795638|FG000|Participant Flow|Intervention|"Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously.~Sodium chloride"
11136828|NCT01795638|FG001|Participant Flow|Placebo|"Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously.~Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35."
11136829|NCT01795638|OG000|Outcome|Intervention|"Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously.~Sodium chloride"
11136830|NCT01795638|OG001|Outcome|Placebo|"Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously.~Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35."
11136831|NCT01795638|EG000|Reported Event|Intervention|"Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously.~Sodium chloride"
11136832|NCT01795638|EG001|Reported Event|Placebo|"Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously.~Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35."
11136833|NCT01795716|BG000|Baseline|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period. In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
11136834|NCT01795716|BG001|Baseline|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
11136835|NCT01795716|BG002|Baseline|Total|Total of all reporting groups
11136836|NCT01795716|FG000|Participant Flow|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period.In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
11136837|NCT01795716|FG001|Participant Flow|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
11136838|NCT01795716|OG000|Outcome|Mesylate Imatinib Capsule|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
11136839|NCT01795716|OG001|Outcome|Glivec|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
11136840|NCT01795716|EG000|Reported Event|Mesylate Imatinib Capsule|Subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
11136841|NCT01795716|EG001|Reported Event|Glivec|Subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
11136842|NCT01795833|BG000|Baseline|Text Message - India|"Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period.~Short text messages: In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic."
11136843|NCT01795833|BG001|Baseline|Text Message - UK|"Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period.~Short text messages: In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic."
11136844|NCT01795833|BG002|Baseline|Control - India|Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period
11136845|NCT01795833|BG003|Baseline|Control - UK|Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period
11136846|NCT01795833|BG004|Baseline|Total|Total of all reporting groups
11136847|NCT01795833|FG000|Participant Flow|Text Messages|"Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period.~Short text messages: In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic."
11136848|NCT01795833|FG001|Participant Flow|Control|Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period
11136849|NCT01795833|OG000|Outcome|Text Messages|"Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period.~Short text messages: In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic."
11136850|NCT01795833|OG001|Outcome|Control|Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period
11136851|NCT01795833|EG000|Reported Event|Text Messages|"Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period.~Short text messages: In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic."
11136852|NCT01795833|EG001|Reported Event|Control|Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period
11136853|NCT01795859|BG000|Baseline|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
11136854|NCT01795859|BG001|Baseline|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
11136855|NCT01795859|BG002|Baseline|Total|Total of all reporting groups
11136856|NCT01795859|FG000|Participant Flow|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
11136857|NCT01795859|FG001|Participant Flow|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
11136858|NCT01795859|OG000|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
11136859|NCT01795859|OG001|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
11136860|NCT01795859|EG000|Reported Event|Placebo|Placebo
11136861|NCT01795859|EG001|Reported Event|SD-809|SD-809
11136862|NCT01795898|BG000|Baseline|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
11136863|NCT01795898|FG000|Participant Flow|Fentanyl|Fentanyl transdermal (through the skin) patches releasing 12.5 microgram (mcg) of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
11136864|NCT01795898|OG000|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
11136865|NCT01795898|EG000|Reported Event|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
11136866|NCT01795937|BG000|Baseline|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.~Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).~Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment A directly preceded treatment B, without an intermittent washout period.~Oral administration with 240 mL water."
11136867|NCT01795937|BG001|Baseline|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C preceded treatment D.~Oral administration with 240 mL water."
11136868|NCT01795937|BG002|Baseline|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E preceded treatment F.~Oral administration with 240 mL water."
11136869|NCT01795937|BG003|Baseline|Total|Total of all reporting groups
11136870|NCT01795937|FG000|Participant Flow|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.~Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).~Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment A directly preceded treatment B, without an intermittent washout period.~Oral administration with 240 mL water."
11136871|NCT01795937|FG001|Participant Flow|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C preceded treatment D.~Oral administration with 240 mL water."
11136872|NCT01795937|FG002|Participant Flow|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E preceded treatment F.~Oral administration with 240 mL water."
11136873|NCT01795937|OG000|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).~Treatment A."
11136874|NCT01795937|OG001|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment B."
11136875|NCT01795937|OG000|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
11136876|NCT01795937|OG001|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
11136877|NCT01795937|OG000|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
11136878|NCT01795937|OG001|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
11136879|NCT01795937|OG000|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
11136880|NCT01795937|EG000|Reported Event|Faldaprevir (Itraconazole Part)|"Faldaprevir: 120 mg once daily with a 120 mg twice daily loading dose on Day -5.~Treatment A."
11136881|NCT01795937|EG001|Reported Event|Faldaprevir+Itraconazole (Itraconazole Part)|"Faldaprevir: 120 mg once daily. Itraconazole: 200 mg once daily with a 200 mg twice daily loading dose on Day -3.~Treatment B."
11136882|NCT01795937|EG002|Reported Event|Atorvastatin (Statins Part)|"Atorvastatin: 10 mg was given as a single dose on Day 1.~Treatment C.~From the time of the single dose atorvastatin administration in treatment C until the time of the first faldaprevir administration in treatment D or until 1 day after the trial completion date of the respective subject."
11136883|NCT01795937|EG003|Reported Event|Rosuvastatin (Statins Part)|"Rosuvastatin: 10 mg was given as a single dose on Day 1.~Treatment E.~From the time of the single dose rosuvastatin administration in treatment E until the time of the first faldaprevir administration in treatment F or until 1 day after the trial completion date."
11136884|NCT01795937|EG004|Reported Event|Faldaprevir (Statins Part)|From the time of the first faldaprevir administration in treatment D or F until the combined administration of faldaprevir with atorvastatin or rosuvastatin in treatment D or F, respectively, or until 1 day after the trial completion date.
10887377|NCT00500266|FG000|Participant Flow|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
11136885|NCT01795937|EG005|Reported Event|Faldaprevir + Atorvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Atorvastatin: 10 mg was given as a single dose on Day 1.~Treatment D.~From the time of the combined administration of faldaprevir with atorvastatin in treatment D until 1 day after the trial completion date."
11136886|NCT01795937|EG006|Reported Event|Faldaprevir + Rosuvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Rosuvastatin: 10 mg was given as a single dose on Day 1.~Treatment F.~From the time of the combined administration of faldaprevir with rosuvastatin in treatment F until 1 day after the trial completion date."
11136887|NCT01796236|BG000|Baseline|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
11136888|NCT01796236|BG001|Baseline|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
11136889|NCT01796236|BG002|Baseline|Total|Total of all reporting groups
11136890|NCT01796236|FG000|Participant Flow|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
11136891|NCT01796236|FG001|Participant Flow|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
11136892|NCT01796236|OG000|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments)."
11136893|NCT01796236|OG001|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
11136894|NCT01796236|OG000|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
11136895|NCT01796236|EG000|Reported Event|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
11136896|NCT01796236|EG001|Reported Event|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
11136897|NCT01796301|BG000|Baseline|Teriparatide|Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
11136898|NCT01796301|BG001|Baseline|Romosozumab|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11136899|NCT01796301|BG002|Baseline|Total|Total of all reporting groups
11136900|NCT01796301|FG000|Participant Flow|Teriparatide|Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
11136901|NCT01796301|FG001|Participant Flow|Romosozumab|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11136902|NCT01796301|OG000|Outcome|Teriparatide|Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
11136903|NCT01796301|OG001|Outcome|Romosozumab|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11136904|NCT01796301|EG000|Reported Event|Teriparatide|Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
11136905|NCT01796301|EG001|Reported Event|Romosozumab|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11136906|NCT01796392|BG000|Baseline|Zephyr Valve Treatment and Optimal Medical Management|"This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.~EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary."
10887378|NCT00500266|OG000|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
11136907|NCT01796392|BG001|Baseline|Optimal Medical Management|"This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.~Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary."
11136908|NCT01796392|BG002|Baseline|Total|Total of all reporting groups
11136909|NCT01796392|FG000|Participant Flow|EBV and Optimal Medical Management|"This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.~EBV: This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary."
11136910|NCT01796392|FG001|Participant Flow|Optimal Medical Management|"This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.~Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary."
11136911|NCT01796392|OG000|Outcome|Zephyr Valve Treatment and Optimal Medical Management|"This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.~EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary."
11136912|NCT01796392|OG001|Outcome|Optimal Medical Management|"This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.~Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary."
11136913|NCT01796392|EG000|Reported Event|Zephyr Valve Treatment and Optimal Medical Management|"This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.~EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary."
11136914|NCT01796392|EG001|Reported Event|Optimal Medical Management|"This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.~Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary."
11136915|NCT01796470|BG000|Baseline|Entospletinib + Idelalisib CLL|Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136916|NCT01796470|BG001|Baseline|Entospletinib + Idelalisib iNHL: FL|Participants with a documented diagnosis of indolent non-Hodgkin lymphoma (iNHL) with follicular lymphoma (FL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months
11136917|NCT01796470|BG002|Baseline|Entospletinib + Idelalisib DLBCL|Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136918|NCT01796470|BG003|Baseline|Entospletinib + Idelalisib MCL|Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136919|NCT01796470|BG004|Baseline|Entospletinib + Idelalisib iNHL: Others|Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136920|NCT01796470|BG005|Baseline|Total|Total of all reporting groups
11136921|NCT01796470|FG000|Participant Flow|Entospletinib + Idelalisib CLL|Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136922|NCT01796470|FG001|Participant Flow|Entospletinib + Idelalisib iNHL: FL|Participants with a documented diagnosis of indolent non-Hodgkin lymphoma (iNHL) with follicular lymphoma (FL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136923|NCT01796470|FG002|Participant Flow|Entospletinib + Idelalisib DLBCL|Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136924|NCT01796470|FG003|Participant Flow|Entospletinib + Idelalisib MCL|Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136925|NCT01796470|FG004|Participant Flow|Entospletinib + Idelalisib iNHL: Others|Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL), and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136926|NCT01796470|OG000|Outcome|Entospletinib + Idelalisib CLL|Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136927|NCT01796470|OG001|Outcome|Entospletinib + Idelalisib iNHL: FL|Participants with a documented diagnosis of indolent non-Hodgkin lymphoma (iNHL) with follicular lymphoma (FL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136928|NCT01796470|OG002|Outcome|Entospletinib + Idelalisib DLBCL|Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136929|NCT01796470|OG003|Outcome|Entospletinib + Idelalisib MCL|Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136930|NCT01796470|OG004|Outcome|Entospletinib + Idelalisib iNHL: Others|Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136931|NCT01796470|OG000|Outcome|Entospletinib + Idelalisib CLL|"Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm.~Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months."
11136932|NCT01796470|OG002|Outcome|Entospletinib + Idelalisib DLBCL|"Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm.~Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months."
11136933|NCT01796470|OG003|Outcome|Entospletinib + Idelalisib MCL|"Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm.~Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months."
11136934|NCT01796470|OG004|Outcome|Entospletinib + Idelalisib iNHL: Others|Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/ Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL), and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136935|NCT01796470|EG000|Reported Event|Entospletinib + Idelalisib CLL|Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136936|NCT01796470|EG001|Reported Event|Entospletinib + Idelalisib iNHL: FL|Participants with a documented diagnosis of indolent non-Hodgkin lymphoma (iNHL) with follicular lymphoma (FL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136937|NCT01796470|EG002|Reported Event|Entospletinib + Idelalisib DLBCL|Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136938|NCT01796470|EG003|Reported Event|Entospletinib + Idelalisib MCL|Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136939|NCT01796470|EG004|Reported Event|Entospletinib + Idelalisib iNHL: Others|Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL), and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
11136940|NCT01796548|BG000|Baseline|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. 'Number of participants analyzed for the baseline characteristic was intent-to-treat (ITT) population which included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.'
11136941|NCT01796548|FG000|Participant Flow|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
11136942|NCT01796548|OG000|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
11136943|NCT01796548|EG000|Reported Event|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
11136944|NCT01796665|BG000|Baseline|Test Product|"Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.~Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%"
11136945|NCT01796665|BG001|Baseline|Reference Product|"Acanya Gel applied to the affected areas of the face once daily.~Acanya Gel"
11136946|NCT01796665|BG002|Baseline|Placebo Product|"Placebo of the Test product applied to the affected areas of the face once daily.~Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product"
11136947|NCT01796665|BG003|Baseline|Total|Total of all reporting groups
11136948|NCT01796665|FG000|Participant Flow|Test Product|"Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.~Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%"
11136949|NCT01796665|FG001|Participant Flow|Reference Product|"Acanya Gel applied to the affected areas of the face once daily.~Acanya Gel"
11136950|NCT01796665|FG002|Participant Flow|Placebo Product|"Placebo of the Test product applied to the affected areas of the face once daily.~Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product"
11136951|NCT01796665|OG000|Outcome|Test Product|"Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.~Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%"
11136952|NCT01796665|OG001|Outcome|Reference Product|"Acanya Gel applied to the affected areas of the face once daily.~Acanya Gel"
11136953|NCT01796665|OG002|Outcome|Placebo Product|"Placebo of the Test product applied to the affected areas of the face once daily.~Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product"
11136954|NCT01796665|EG000|Reported Event|Test Product|"Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.~Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%"
11136955|NCT01796665|EG001|Reported Event|Reference Product|"Acanya Gel applied to the affected areas of the face once daily.~Acanya Gel"
11136956|NCT01796665|EG002|Reported Event|Placebo Product|"Placebo of the Test product applied to the affected areas of the face once daily.~Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product"
11136957|NCT01796860|BG000|Baseline|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
11136958|NCT01796860|FG000|Participant Flow|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
11136959|NCT01796860|OG000|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
11136960|NCT01796860|EG000|Reported Event|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
11136961|NCT01796912|BG000|Baseline|All Study Participant|Participant were randomised to undergoing lipoprotein apheresis weekly for three months or sham apheresis weekly for three months with assessment of myocardial perfusion, carotid atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina symptoms and quality of life at the beginning and end of treatment. Patients then crossovered to the opposite study arm with the protocol repeated.
11136962|NCT01796912|FG000|Participant Flow|First Lipoprotein Apheresis, Then Sham Apheresis|Three months of weekly lipoprotein apheresis, 1 month of washout then three month of sham apheresis
11136963|NCT01796912|FG001|Participant Flow|First Sham Apheresis, Then Lipoprotein Apheresis|Three months of weekly sham apheresis, 1 month of washout then three months of weekly lipoprotein apheresis
11136964|NCT01796912|OG000|Outcome|Lipoprotein Apheresis|Three months of weekly lipoprotein apheresis
11136965|NCT01796912|OG001|Outcome|Sham Apheresis|Three months of weekly sham apheresis
11136966|NCT01796912|OG000|Outcome|Lipoprotein Apheresis|Lipoprotein Apheresis: Weekly lipoprotein apheresis for 3 months
11136967|NCT01796912|OG001|Outcome|Sham Apheresis|Sham Apheresis: Weekly sham (placebo) apheresis for 3 months
11136968|NCT01796912|EG000|Reported Event|Lipoprotein Apheresis|Three months of weekly lipoprotein apheresis
11136969|NCT01796912|EG001|Reported Event|Sham Apheresis|Three months of weekly sham apheresis
11136970|NCT01796964|BG000|Baseline|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
11136971|NCT01796964|BG001|Baseline|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
11136972|NCT01796964|BG002|Baseline|Total|Total of all reporting groups
11136973|NCT01796964|FG000|Participant Flow|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
11136974|NCT01796964|FG001|Participant Flow|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
11136975|NCT01796964|OG000|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
11136976|NCT01796964|OG001|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
11136977|NCT01796964|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study
11136978|NCT01796964|EG001|Reported Event|ESBA 1008|All subjects who were randomized and received at least 1 IVT injection of ESBA1008 solution
11136979|NCT01796964|EG002|Reported Event|EYLEA|All subjects who were randomized and received at least 1 IVT injection of Aflibercept
11136980|NCT01796977|BG000|Baseline|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Each study participant was supposed to act as her own control (one breast to be treated with the test article, the other breast with the control article)."
11136981|NCT01796977|FG000|Participant Flow|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Each study participant acted as her own control (one breast of each participant was treated with OxyGenesys, while the other breast was treated with the standard dressing (control))."
11136982|NCT01796977|OG000|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~OxyGenesys Dissolved Oxygen Dressing"
11136983|NCT01796977|OG001|Outcome|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Standard Gauze Dressing"
11136984|NCT01796977|OG000|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
11136985|NCT01796977|OG001|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
11136986|NCT01796977|OG000|Outcome|All Available Study Participants|Each study participant was treated with OxyGenesys Dissolved Oxygen Dressing on one breast and standard gauze dressing on the opposite breast.
11136987|NCT01796977|EG000|Reported Event|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~OxyGenesys Dissolved Oxygen Dressing"
11136988|NCT01796977|EG001|Reported Event|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Standard Gauze Dressing"
11136989|NCT01797029|BG000|Baseline|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
11136990|NCT01797029|BG001|Baseline|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
11136991|NCT01797029|BG002|Baseline|Total|Total of all reporting groups
11136992|NCT01797029|FG000|Participant Flow|Vaccine|A single dose of Serum Institute of India, Ltd. (SIIL) Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
11136993|NCT01797029|FG001|Participant Flow|Placebo|Inactive placebo will be identical to reconstituted Serum Institute of India, Ltd. (SIIL) LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
11136994|NCT01797029|OG000|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
11136995|NCT01797029|OG001|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
11136996|NCT01797029|EG000|Reported Event|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
11136997|NCT01797029|EG001|Reported Event|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
11136998|NCT01797081|BG000|Baseline|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11136999|NCT01797081|BG001|Baseline|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137000|NCT01797081|BG002|Baseline|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
11137001|NCT01797081|BG003|Baseline|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
11137002|NCT01797081|BG004|Baseline|Total|Total of all reporting groups
11137003|NCT01797081|FG000|Participant Flow|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137004|NCT01797081|FG001|Participant Flow|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137005|NCT01797081|FG002|Participant Flow|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
11137006|NCT01797081|FG003|Participant Flow|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
11137007|NCT01797081|OG000|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137008|NCT01797081|OG001|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137009|NCT01797081|OG002|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
11137010|NCT01797081|EG000|Reported Event|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137011|NCT01797081|EG001|Reported Event|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137012|NCT01797081|EG002|Reported Event|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
11137013|NCT01797094|BG000|Baseline|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137014|NCT01797094|BG001|Baseline|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137015|NCT01797094|BG002|Baseline|Total|Total of all reporting groups
11137016|NCT01797094|FG000|Participant Flow|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137017|NCT01797094|FG001|Participant Flow|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137018|NCT01797094|OG000|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137019|NCT01797094|OG001|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137020|NCT01797094|EG000|Reported Event|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137021|NCT01797094|EG001|Reported Event|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
11137022|NCT01797120|BG000|Baseline|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
11137023|NCT01797120|BG001|Baseline|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
11137024|NCT01797120|BG002|Baseline|Total|Total of all reporting groups
11137025|NCT01797120|FG000|Participant Flow|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
11137026|NCT01797120|FG001|Participant Flow|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
11137027|NCT01797120|OG000|Outcome|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
11137028|NCT01797120|OG001|Outcome|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
11137029|NCT01797120|EG000|Reported Event|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
11137030|NCT01797120|EG001|Reported Event|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
11137031|NCT01797159|BG000|Baseline|Hippocampal-sparing PCI|"Hippocampal-sparing PCI 25 Gy in 10 fractions~Hippocampal-sparing Prophylactic Cranial Irradiation"
11137032|NCT01797159|FG000|Participant Flow|Hippocampal-sparing PCI|Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions
11137033|NCT01797159|OG000|Outcome|Hippocampal-sparing PCI|"Hippocampal-sparing PCI 25 Gy in 10 fractions~Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation"
11137034|NCT01797159|OG000|Outcome|Hippocampal-sparing PCI|Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions
11137035|NCT01797159|EG000|Reported Event|Hippocampal-sparing PCI|"Hippocampal-sparing PCI 25 Gy in 10 fractions~Hippocampal-sparing Prophylactic Cranial Irradiation"
11137036|NCT01797185|BG000|Baseline|SPARC1104 Group 1|Subjects who completed Study CLR_09_21
11137037|NCT01797185|BG001|Baseline|SPARC1104 Group 2|Subjects who are on Dose regimen I of SPARC0921 at entry
11137038|NCT01797185|BG002|Baseline|SPARC1104 Group 3|Subjects Entering the Trial with no Prior Treatment with SPARC0921
11137039|NCT01797185|BG003|Baseline|Total|Total of all reporting groups
11137040|NCT01797185|FG000|Participant Flow|SPARC1104 Group 1|Subjects who completed Part 3 of Study CLR_09_21 Dose: One or two capsules once daily
11137041|NCT01797185|FG001|Participant Flow|SPARC1104 Group 2|Subjects who are on Dose regimen I of SPARC0921 at entry. Dose: One or two capsules once daily
11137042|NCT01797185|FG002|Participant Flow|SPARC1104 Group 3|Subjects Entering the Trial with no Prior Treatment with SPARC0921 Dose: One or two capsules once daily
11137043|NCT01797185|OG000|Outcome|SPARC1104 Group 1|Subjects who completed Study CLR_09_21
11137044|NCT01797185|OG001|Outcome|SPARC1104 Group 2|Subjects who are on Dose regimen I of SPARC0921 at entry
11137045|NCT01797185|OG002|Outcome|SPARC1104 Group 3|Subjects Entering the Trial with no Prior Treatment with SPARC0921
11137046|NCT01797185|EG000|Reported Event|SPARC1104 Group 1|Subjects who completed Study CLR_09_21
11137047|NCT01797185|EG001|Reported Event|SPARC1104 Group 2|Subjects who are on Dose regimen I of SPARC0921 at entry
11137048|NCT01797185|EG002|Reported Event|SPARC1104 Group 3|Subjects Entering the Trial with no Prior Treatment with SPARC0921
11149694|NCT01872689|BG000|Baseline|Monotherapy (Cohort A): Placebo|Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11137049|NCT01797263|BG000|Baseline|Yoga|A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
11137050|NCT01797263|BG001|Baseline|Structured Exercise|A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
11137051|NCT01797263|BG002|Baseline|Total|Total of all reporting groups
11137052|NCT01797263|FG000|Participant Flow|Yoga|A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
11137053|NCT01797263|FG001|Participant Flow|Structured Exercise|A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
11137054|NCT01797263|OG000|Outcome|Yoga|A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
11137055|NCT01797263|OG001|Outcome|Structured Exercise|A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
11137056|NCT01797263|EG000|Reported Event|Yoga|A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
11137057|NCT01797263|EG001|Reported Event|Structured Exercise|A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
11137058|NCT01797302|BG000|Baseline|Vitamin D3 2000 IU|"Vitamin D3 2000 IU tablet once daily by mouth for 6 months~Vitamin D3: Tablet form"
11137059|NCT01797302|BG001|Baseline|Vitamin D3 1000 IU|"Vitamin D3 1000 IU tablet by mouth once daily for 6 months~Vitamin D3: Tablet form"
11137060|NCT01797302|BG002|Baseline|Vitamin D3 600 IU|"Vitamin D3 600 IU tablet by mouth once daily for 6 months~Vitamin D3: Tablet form"
11137061|NCT01797302|BG003|Baseline|Total|Total of all reporting groups
11137062|NCT01797302|FG000|Participant Flow|Vitamin D3 2000 IU|"Vitamin D3 2000 IU tablet once daily by mouth for 6 months~Vitamin D3: Tablet form"
11137063|NCT01797302|FG001|Participant Flow|Vitamin D3 1000 IU|"Vitamin D3 1000 IU tablet by mouth once daily for 6 months~Vitamin D3: Tablet form"
11137064|NCT01797302|FG002|Participant Flow|Vitamin D3 600 IU|"Vitamin D3 600 IU tablet by mouth once daily for 6 months~Vitamin D3: Tablet form"
11137065|NCT01797302|OG000|Outcome|Vitamin D3 2000 IU|"Vitamin D3 2000 IU tablet once daily by mouth for 6 months~Vitamin D3: Tablet form"
11137066|NCT01797302|OG001|Outcome|Vitamin D3 1000 IU|"Vitamin D3 1000 IU tablet by mouth once daily for 6 months~Vitamin D3: Tablet form"
11137067|NCT01797302|OG002|Outcome|Vitamin D3 600 IU|"Vitamin D3 600 IU tablet by mouth once daily for 6 months~Vitamin D3: Tablet form"
11137068|NCT01797302|EG000|Reported Event|Vitamin D3 2000 IU|"Vitamin D3 2000 IU tablet once daily by mouth for 6 months~Vitamin D3: Tablet form"
11137069|NCT01797302|EG001|Reported Event|Vitamin D3 1000 IU|"Vitamin D3 1000 IU tablet by mouth once daily for 6 months~Vitamin D3: Tablet form"
11137070|NCT01797302|EG002|Reported Event|Vitamin D3 600 IU|"Vitamin D3 600 IU tablet by mouth once daily for 6 months~Vitamin D3: Tablet form"
11137071|NCT01797328|BG000|Baseline|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
11137072|NCT01797328|BG001|Baseline|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
11137073|NCT01797328|BG002|Baseline|Total|Total of all reporting groups
11137074|NCT01797328|FG000|Participant Flow|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
11137075|NCT01797328|FG001|Participant Flow|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
11137076|NCT01797328|OG000|Outcome|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
11137077|NCT01797328|OG001|Outcome|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
11137078|NCT01797328|EG000|Reported Event|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering~no reported adverse events"
11137079|NCT01797328|EG001|Reported Event|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
11137080|NCT01797432|BG000|Baseline|Combined IL Kenalog and Restylane|"Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp~Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp~Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp"
11137081|NCT01797432|FG000|Participant Flow|Combined IL Kenalog and Restylane|"Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp~Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp~Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp"
11137082|NCT01797432|OG000|Outcome|Combined IL Kenalog and Restylane|"Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp~Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp~Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp"
11137083|NCT01797432|EG000|Reported Event|Combined IL Kenalog and Restylane|"Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp~Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp~Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp"
11137084|NCT01797445|BG000|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
11137085|NCT01797445|BG001|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
11137086|NCT01797445|BG002|Baseline|Total|Total of all reporting groups
11137087|NCT01797445|FG000|Participant Flow|E/C/F/TAF|"Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks.~Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country."
11137088|NCT01797445|FG001|Participant Flow|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.~Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country."
11137089|NCT01797445|OG000|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
11137090|NCT01797445|OG001|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
11137091|NCT01797445|EG000|Reported Event|E/C/F/TAF (Double-Blind Phase)|Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TAF group, who received E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks.
11137092|NCT01797445|EG001|Reported Event|E/C/F/TDF (Double-Blind Phase)|Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TDF group, who received E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.
11137093|NCT01797445|EG002|Reported Event|Open-Label E/C/F/TAF From E/C/F/TAF|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the E/C/F/TAF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.
11137094|NCT01797445|EG003|Reported Event|Open-Label E/C/F/TAF From E/C/F/TDF|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the E/C/F/TDF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.
11149695|NCT01872689|BG001|Baseline|Monotherapy (Cohort A): Lebrikizumab|Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11137095|NCT01797458|BG000|Baseline|Hall Technique|"This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required.~Hall Technique: Technique:~Removal of dental plaque and rest of aliments from the cavity~Selection of the SSC~If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment~Dry the crown and fill with glass-ionomer luting cement~Place the crown over the tooth~Removal of cement excesses from the crown margins~The child should be asked to keep biting on the crown until the cement has set"
11137096|NCT01797458|BG001|Baseline|Non-Restorative Caries Treatment|"This is a less operative approach, here carious lesions are opened removing the overhanging enamel and making the cavity accessible for biofilm removal. No carious dentine was removed from the pulpal wall and no local anaesthesia was placed. Fluoride varnish (Duraphat, GABA, Lörrach, Germany) was applied to the cavity. Parents/children were trained to clean the cavity by brushing using a buccolingual technique.~Recall interval for these participants was every 3 months."
11137097|NCT01797458|BG002|Baseline|Conventional Restoration|"Conventional Restoration: Technique:~Local anesthesia should be used when needed~Complete caries removal and cavity preparation~Use a matrix band and a wedge to tightly hold the band against the tooth~Place the material (Composite) under cotton wool roll isolation and continuous aspiration.~Check contacts and occlusion, and polish the restoration."
11137098|NCT01797458|BG003|Baseline|Total|Total of all reporting groups
11137099|NCT01797458|FG000|Participant Flow|Hall Technique|"This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required.~Technique:~Removal of dental plaque and rest of aliments from the cavity~Selection of the SSC~If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment~Dry the crown and fill with glass-ionomer luting cement~Place the crown over the tooth~Removal of cement excesses from the crown margins~The child should be asked to keep biting on the crown until the cement has set"
11137100|NCT01797458|FG001|Participant Flow|Non-Restorative Caries Treatment|"Carious lesions are opened removing the overhanging enamel and making the cavity accessible for biofilm removal. No carious dentine was removed from the pulpal wall and no local anaesthesia was placed. Fluoride varnish (Duraphat ®) was applied to the cavity. Parents/children were trained to clean the cavity by brushing using a buccolingual technique.~Recall intervals were every 3 months."
11137101|NCT01797458|FG002|Participant Flow|Conventional Restoration|"Technique:~Local anaesthesia was used when needed~Complete caries removal and cavity preparation~Use a matrix band and a wedge to tightly hold the band against the tooth~Place the material (Compomer)~Check contacts and occlusion, and polish the restoration"
11137102|NCT01797458|OG000|Outcome|Hall Technique|"This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required.~Hall Technique: Technique:~Removal of dental plaque and rest of aliments from the cavity~Selection of the SSC~If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment~Dry the crown and fill with glass-ionomer luting cement~Place the crown over the tooth~Removal of cement excesses from the crown margins~The child should be asked to keep biting on the crown until the cement has set"
11137103|NCT01797458|OG001|Outcome|Non-Restorative Caries Treatment|"This is a less operative approach, here carious lesions are opened removing the overhanging enamel and making the cavity accessible for biofilm removal. No carious dentine will be removed from the pulpal wall and no local anaesthesia will be placed. Fluoride varnish (Duraphat, GABA, Lörrach, Germany) will be applied to the cavity. Parents/children will be trained to clean the cavity by brushing using a buccolingual technique.~Non-Restorative Caries Treatment: Technique:~Use high-speed bur to remove the undermined enamel and make the cavity accessible for plaque removal. Do not remove the contact area~Clean, dry the cavity and apply Duraphat® varnish fluoride (50/mg/ml)~Show the cavity to patient/parents and give them tooth-brushing instructions~Tell to parents that good plaque control is the key for this treatment~The recall interval for these patients is every 3 months."
11137104|NCT01797458|OG002|Outcome|Conventional Restoration|"Conventional restorations (dental fillings) with complete caries removal will be performed. Local anaesthesia will be placed when needed. All cavities will be restored with Compomer (Dyract, Dentsply, Konstanz, Germany) under cotton wool roll isolation and continuous aspiration.~Technique:~Local anesthesia should be used when needed~Complete caries removal and cavity preparation~Use a matrix band and a wedge to tightly hold the band against the tooth~Place the material (Composer)~Check contacts and occlusion, and polish the restoration"
11137105|NCT01797458|OG000|Outcome|Non-Restorative Caries Treatment|Irreversible pulpitis (history of spontaneous pain or precipitated pain caused by thermal or other stimuli) or dental abscess requiring pulpotomy or extraction.
11137106|NCT01797458|OG001|Outcome|Hall Technique|Irreversible pulpitis (history of spontaneous pain or precipitated pain caused by thermal or other stimuli) or dental abscess requiring pulpotomy or extraction Crown loss and tooth is unrestorable.
11137107|NCT01797458|OG002|Outcome|Conventional Restoration|"Signs or symptoms of reversible pulpitis (no spontaneous pain) requiring pulpotomy. Signs or symptoms of irreversible pulpitis (history of spontaneous pain or precipitated pain caused by thermal or other stimuli) or dental abscess.~Restoration loss and tooth is unrestorable."
11137108|NCT01797458|OG000|Outcome|Hall Technique|A single assessment of participant´s behaviour during the Hall Technique procedure was performed by the dentist using the Frankl Behavior Rating Scale.
11137109|NCT01797458|OG001|Outcome|Non-Restorative Caries Treatment|A single assessment of participant´s behaviour during the Non-Restorative Caries Treatment procedure was performed by the dentist using the Frankl Behavior Rating Scale.
11137110|NCT01797458|OG002|Outcome|Conventional Restoration|A single assessment of participant´s behaviour during the conventional restoration was performed by the dentist using the Frankl Behavior Rating Scale.
11137111|NCT01797458|OG000|Outcome|Hall Technique|A single assessment of participant´s pain perception during the Hall Technique was performed by the dentist using the Visual Analog Scale of Pain.
11137112|NCT01797458|OG001|Outcome|Non-Restorative Caries Treatment|A single assessment of participant´s pain perception during the Non-Restorative Caries Treatment was performed by the dentist using the Visual Analog Scale of Pain.
11137113|NCT01797458|OG002|Outcome|Conventional Restoration|A single assessment of participant´s pain perception during the conventional restoration was performed by the dentist using the Visual Analog Scale of Pain.
11137114|NCT01797458|EG000|Reported Event|Hall Technique|No observed/reported
11137115|NCT01797458|EG001|Reported Event|Non-Restorative Caries Treatment|No observed/reported
11137116|NCT01797458|EG002|Reported Event|Conventional Restoration|No observed/reported
11137117|NCT01797471|BG000|Baseline|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
11137118|NCT01797471|FG000|Participant Flow|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
11137119|NCT01797471|OG000|Outcome|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
11137120|NCT01797471|EG000|Reported Event|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
11137121|NCT01797484|BG000|Baseline|Ranolazine|"Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days~Ranolazine: Improvement of myocardial microcirculation"
11137122|NCT01797484|BG001|Baseline|No Additional Medication|No additional medication - control group
11137123|NCT01797484|BG002|Baseline|Total|Total of all reporting groups
11137124|NCT01797484|FG000|Participant Flow|Ranolazine|"Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days~Ranolazine: Improvement of myocardial microcirculation"
11137125|NCT01797484|FG001|Participant Flow|No Additional Medication|No additional medication - control group
11137126|NCT01797484|OG000|Outcome|Ranolazine|"Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days~Ranolazine: Improvement of myocardial microcirculation"
11137127|NCT01797484|OG001|Outcome|No Additional Medication|No additional medication - control group
11137128|NCT01797484|EG000|Reported Event|Ranolazine|"Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days~Ranolazine: Improvement of myocardial microcirculation"
11137129|NCT01797484|EG001|Reported Event|No Additional Medication|No additional medication - control group
11137130|NCT01797536|BG000|Baseline|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
11137131|NCT01797536|BG001|Baseline|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
11137132|NCT01797536|BG002|Baseline|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
11137133|NCT01797536|BG003|Baseline|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
11137134|NCT01797536|BG004|Baseline|Total|Total of all reporting groups
11137135|NCT01797536|FG000|Participant Flow|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
11137136|NCT01797536|FG001|Participant Flow|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
11137137|NCT01797536|FG002|Participant Flow|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
11137138|NCT01797536|FG003|Participant Flow|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
11137139|NCT01797536|OG000|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
11137140|NCT01797536|OG001|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
11137141|NCT01797536|OG002|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
11137142|NCT01797536|OG003|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
11137143|NCT01797536|EG000|Reported Event|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
11137144|NCT01797536|EG001|Reported Event|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
11137145|NCT01797536|EG002|Reported Event|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
11137146|NCT01797536|EG003|Reported Event|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
11137147|NCT01797562|BG000|Baseline|Positive Response Rates: 7 New and 4 Reformulated Allergens|"Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated~Panels 1.3, 2.2 and 3.2 experimental allergens: Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application."
11137148|NCT01797562|FG000|Participant Flow|Evaluation of T.R.U.E. Test Experimental Allergens|11 experimental patch test allergens:0.60mg/cm2 neomycin, 0.054 mg/cm2 potassium dichromate, 0.50 mg/cm2 fragrance mix, 0.050 mg/cm2 ethylenediamine, 0.075 mg/cm2 gold,0.020 mg/cm2 hydroxycortisone, 0.60 mg/cm2 bacitracin, 0.0030 mg/cm2 parthenolide,0.050 mg/cm2 disperse blue and 0.25 mg/cm2 bronopol were applied to the skin for 48 hours.
11137149|NCT01797562|OG000|Outcome|Positive Response Rates: 7 New and 4 Reformulated Allergens|"Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated~Panels 1.3, 2.2 and 3.2 experimental allergens: Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application."
11137150|NCT01797562|OG000|Outcome|Evaluation of T.R.U.E. Test Experimental Allergens|Percentage of positive patch test results will be reported for 11 experimental allergens tested in a pediatric population
11137151|NCT01797562|EG000|Reported Event|Evaluation of T.R.U.E. Test Experimental Allergens|Adverse events were captured for subjects patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated
11137152|NCT01797575|BG000|Baseline|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
11137153|NCT01797575|BG001|Baseline|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137154|NCT01797575|BG002|Baseline|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137155|NCT01797575|BG003|Baseline|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
11137156|NCT01797575|BG004|Baseline|Total|Total of all reporting groups
11137157|NCT01797575|FG000|Participant Flow|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
11137158|NCT01797575|FG001|Participant Flow|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137159|NCT01797575|FG002|Participant Flow|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137160|NCT01797575|FG003|Participant Flow|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
11137161|NCT01797575|OG000|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137162|NCT01797575|OG001|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
11137163|NCT01797575|OG002|Outcome|N-Acetyl Cysteine (NAC)|Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating > 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
11137164|NCT01797575|OG003|Outcome|Placebo|research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
11137165|NCT01797575|OG000|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
11137166|NCT01797575|OG001|Outcome|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137167|NCT01797575|OG002|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137168|NCT01797575|OG003|Outcome|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
11137169|NCT01797575|EG000|Reported Event|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
11137170|NCT01797575|EG001|Reported Event|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137171|NCT01797575|EG002|Reported Event|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
11137172|NCT01797575|EG003|Reported Event|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
11137173|NCT01797705|BG000|Baseline|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
11137174|NCT01797705|FG000|Participant Flow|All Subjects|All enrolled subjects
11137175|NCT01797705|OG000|Outcome|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
11137176|NCT01797705|EG000|Reported Event|Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
11137177|NCT01797731|BG000|Baseline|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
11137178|NCT01797731|BG001|Baseline|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
11137179|NCT01797731|BG002|Baseline|Total|Total of all reporting groups
11137180|NCT01797731|FG000|Participant Flow|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
11137181|NCT01797731|FG001|Participant Flow|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
11137182|NCT01797731|OG000|Outcome|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
11137183|NCT01797731|OG001|Outcome|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
11137184|NCT01797731|EG000|Reported Event|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
11137185|NCT01797731|EG001|Reported Event|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
11137186|NCT01797783|BG000|Baseline|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
11137187|NCT01797783|BG001|Baseline|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
11137188|NCT01797783|BG002|Baseline|Total|Total of all reporting groups
11137189|NCT01797783|FG000|Participant Flow|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
11137190|NCT01797783|FG001|Participant Flow|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
11137191|NCT01797783|OG000|Outcome|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
11137192|NCT01797783|OG001|Outcome|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
11137193|NCT01797783|OG000|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
11137194|NCT01797783|OG001|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
11137195|NCT01797783|OG002|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
11137196|NCT01797783|OG003|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
11137197|NCT01797783|OG004|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
11137198|NCT01797783|OG005|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
11137199|NCT01797783|OG006|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
11137200|NCT01797783|OG007|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
11137201|NCT01797783|EG000|Reported Event|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
11137202|NCT01797783|EG001|Reported Event|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
11137203|NCT01797822|BG000|Baseline|Dexamethasone, Artificial Tears|"Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes Artificial tears four times a day for two weeks in both eyes~dexamethasone, artificial tears"
11137204|NCT01797822|FG000|Participant Flow|Artificial Tears First, Then Dexamethasone 0.01%|Artificial tears four times a day for two weeks in both eyes, then Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes
11137205|NCT01797822|OG000|Outcome|Artificial Tears|Artificial tears four times a day for two weeks in both eyes/Artificial tears
11137206|NCT01797822|OG001|Outcome|Dexamethasone|Dexamethasone 4 times per day for 2 weeks in both eyes/Dexamethasone
11137207|NCT01797822|EG000|Reported Event|Dexamethasone|Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes
11137208|NCT01797822|EG001|Reported Event|Artificial Tear|Artificial tears four times a day for two weeks in both eyes
11137209|NCT01797835|BG000|Baseline|CHAT Brief MI Intervention|"Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.~CHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care."
11137210|NCT01797835|BG001|Baseline|Usual Care|"Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.~usual care: Youth receive a brochure with information on AOD use."
11137211|NCT01797835|BG002|Baseline|Total|Total of all reporting groups
11137212|NCT01797835|FG000|Participant Flow|CHAT Brief MI Intervention|"Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.~CHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care."
11137213|NCT01797835|FG001|Participant Flow|Usual Care|"Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.~usual care: Youth receive a brochure with information on AOD use."
11137214|NCT01797835|OG000|Outcome|Usual Care|"Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.~usual care: Youth receive a brochure with information on AOD use."
11137215|NCT01797835|OG001|Outcome|CHAT Brief MI Intervention|"Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.~CHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care."
11137216|NCT01797835|EG000|Reported Event|Usual Care|"Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure.~usual care: Youth receive a brochure with information on AOD use."
11137217|NCT01797835|EG001|Reported Event|CHAT Brief MI Intervention|"Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing.~CHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care."
11137218|NCT01797965|BG000|Baseline|IFN β-1a 30 µg (301)/DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.
11137219|NCT01797965|BG001|Baseline|DAC HYP 150 mg (301) /DAC HYP 150 mg (303)|Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.
11137220|NCT01797965|BG002|Baseline|DAC HYP 150 mg (302) /DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
11137221|NCT01797965|BG003|Baseline|DAC HYP 150 mg (203) /DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.
11137222|NCT01797965|BG004|Baseline|Total|Total of all reporting groups
11137223|NCT01797965|FG000|Participant Flow|IFN β-1a 30 µg (301)/DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.
11137224|NCT01797965|FG001|Participant Flow|DAC HYP 150 mg (301) /DAC HYP 150 mg (303)|Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.
11137225|NCT01797965|FG002|Participant Flow|DAC HYP 150 mg (302) /DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
11137226|NCT01797965|FG003|Participant Flow|DAC HYP 150 mg (203) /DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.
11137227|NCT01797965|OG000|Outcome|IFN β-1a 30 µg (301)/DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.
11137228|NCT01797965|OG001|Outcome|DAC HYP 150 mg (301) /DAC HYP 150 mg (303)|Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.
11137229|NCT01797965|OG002|Outcome|DAC HYP 150 mg (203) /DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.
11137230|NCT01797965|OG003|Outcome|DAC HYP 150 mg (302) /DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
11137231|NCT01797965|OG000|Outcome|DAC HYP 150 mg|All participants who received DAC HYP 150 mg SC injection in study 205MS303.
11137232|NCT01797965|EG000|Reported Event|IFN β-1a 30 µg (301)/DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received IFN β-1a 30 µg IM injection once weekly in study 301 every 4 weeks for up to 144 weeks.
11137233|NCT01797965|EG001|Reported Event|DAC HYP 150 mg (301) /DAC HYP 150 mg (303)|Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.
11137234|NCT01797965|EG002|Reported Event|DAC HYP 150 mg (302) /DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
11137235|NCT01797965|EG003|Reported Event|DAC HYP 150 mg (203) /DAC HYP 150 mg (303)|DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.
11137236|NCT01798056|BG000|Baseline|GSK1437173A Group|Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137237|NCT01798056|BG001|Baseline|Placebo Group|Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137238|NCT01798056|BG002|Baseline|Total|Total of all reporting groups
11137239|NCT01798056|FG000|Participant Flow|GSK1437173A Group|Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137240|NCT01798056|FG001|Participant Flow|Placebo Group|Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137241|NCT01798056|OG000|Outcome|GSK1437173A-PreChemo|Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137242|NCT01798056|OG001|Outcome|Placeb-PreChemo|Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137243|NCT01798056|OG000|Outcome|GSK1437173A Group|Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137244|NCT01798056|OG001|Outcome|Placebo Group|Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137245|NCT01798056|EG000|Reported Event|GSK1437173A Group|Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137246|NCT01798056|EG001|Reported Event|Placebo Group|Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
11137247|NCT01798134|BG000|Baseline|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
11137248|NCT01798134|FG000|Participant Flow|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
11137249|NCT01798134|OG000|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
11137250|NCT01798134|EG000|Reported Event|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
11137251|NCT01798186|BG000|Baseline|Cannabis 5% THC, no Vent|passive exposure to 5% THC cannabis smoke, unventilated room
11137252|NCT01798186|BG001|Baseline|Cannabis 11% THC, no Vent|passive exposure to 11% THC cannabis smoke, unventilated room
11137253|NCT01798186|BG002|Baseline|Cannabis 11% THC, Vent|passive exposure to 11% THC cannabis smoke, ventilated room
11137254|NCT01798186|BG003|Baseline|Smokers|cannabis smokers
11137255|NCT01798186|BG004|Baseline|Total|Total of all reporting groups
11137256|NCT01798186|FG000|Participant Flow|Cannabis 5% THC, no Ventilation|passive exposure to 5% THC in an unventilated room
11137257|NCT01798186|FG001|Participant Flow|Cannabis 11% THC, no Ventilation|passive exposure to 11% THC cannabis smoke in an unventilated room
11137258|NCT01798186|FG002|Participant Flow|Cannabis 11% THC, Ventilated|passive exposure to 11% THC cannabis smoke in a room with active air ventilation
11137259|NCT01798186|FG003|Participant Flow|Active Smokers|Participants that smoked cannabis
11137260|NCT01798186|OG000|Outcome|5% THC Cannabis, no Vent|passive exposure to 5%THC cannabis smoke in unventilated room
11137261|NCT01798186|OG001|Outcome|11% THC Cannabis Smoke, no Vent|passive exposure to 11% THC cannabis smoke in unventilated room
11137262|NCT01798186|OG002|Outcome|11% THC Cannabis, Vent|passive exposure to 11% THC cannabis smoke in ventilated room
11137263|NCT01798186|OG000|Outcome|5%THC Cannabis, no Ventilation|passive exposure to 5% THC cannabis smoke, no room ventilation
11137264|NCT01798186|OG001|Outcome|11%THC Cannabis, no Ventilation|passive exposure to 11% THC cannabis smoke, no room ventilation
11137265|NCT01798186|OG002|Outcome|11% THC Cannabis, no Ventilation|passive exposure to 5% THC cannabis smoke, with active room ventilation
11137266|NCT01798186|OG000|Outcome|5%THC, no Vent|passive 5% THC cannabis smoke, no room ventilation
11137267|NCT01798186|OG002|Outcome|11% THC Cannabis, Ventilated|passive exposure to 11% THC cannabis smoke in ventilated room
11137268|NCT01798186|EG000|Reported Event|5% THC Cannabis Smoke, no Ventilation|passive exposure to 5%THC cannabis smoke in unventilated room
11137269|NCT01798186|EG001|Reported Event|11% THC Cannabis Smoke, no Ventilation|passive exposure to 11%THC cannabis smoke in unventilated room
11137270|NCT01798186|EG002|Reported Event|11% THC Cannabis Smoke, Ventilation|passive exposure to 11%THC cannabis smoke in ventilated room
11137271|NCT01798225|BG000|Baseline|Control|"Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.~Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills."
11137272|NCT01798225|BG001|Baseline|Doxycycline|"Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills)~Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)"
11137273|NCT01798225|BG002|Baseline|Total|Total of all reporting groups
11137274|NCT01798225|FG000|Participant Flow|Control|"Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.~Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills."
11137275|NCT01798225|FG001|Participant Flow|Doxycycline|"Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills)~Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)"
11137276|NCT01798225|OG000|Outcome|Control|"Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.~Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills."
11137277|NCT01798225|OG001|Outcome|Doxycycline|"Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills)~Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)"
11137278|NCT01798225|EG000|Reported Event|Control|"Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.~Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills."
11137279|NCT01798225|EG001|Reported Event|Doxycycline|"Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills)~Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)"
11137280|NCT01798264|BG000|Baseline|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137281|NCT01798264|BG001|Baseline|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137282|NCT01798264|BG002|Baseline|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137283|NCT01798264|BG003|Baseline|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137284|NCT01798264|BG004|Baseline|Total|Total of all reporting groups
11137285|NCT01798264|FG000|Participant Flow|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137286|NCT01798264|FG001|Participant Flow|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137287|NCT01798264|FG002|Participant Flow|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137288|NCT01798264|FG003|Participant Flow|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137289|NCT01798264|OG000|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137290|NCT01798264|OG001|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137291|NCT01798264|OG002|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137292|NCT01798264|OG003|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137293|NCT01798264|EG000|Reported Event|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137294|NCT01798264|EG001|Reported Event|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137295|NCT01798264|EG002|Reported Event|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137296|NCT01798264|EG003|Reported Event|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
11137297|NCT01798316|BG000|Baseline|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes"
11137298|NCT01798316|BG001|Baseline|Standard of Care|"Standard of care pain management regimen including opioids~Standard of Care: No IV acetaminophen"
11137299|NCT01798316|BG002|Baseline|Total|Total of all reporting groups
11137300|NCT01798316|FG000|Participant Flow|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes"
11137301|NCT01798316|FG001|Participant Flow|Standard of Care|"Standard of care pain management regimen including opioids~Standard of Care: without IV acetaminophen"
11137302|NCT01798316|OG000|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
11137303|NCT01798316|OG001|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
11137304|NCT01798316|OG001|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
11137305|NCT01798316|OG000|Outcome|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
11137306|NCT01798316|EG000|Reported Event|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
11137307|NCT01798316|EG001|Reported Event|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
11137308|NCT01798394|BG000|Baseline|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
11137309|NCT01798394|BG001|Baseline|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
11137310|NCT01798394|BG002|Baseline|Total|Total of all reporting groups
11137311|NCT01798394|FG000|Participant Flow|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
11137312|NCT01798394|FG001|Participant Flow|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
11137313|NCT01798394|OG000|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
11137314|NCT01798394|OG001|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
11137315|NCT01798394|EG000|Reported Event|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
11137316|NCT01798394|EG001|Reported Event|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
11137317|NCT01798485|BG000|Baseline|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
11137318|NCT01798485|BG001|Baseline|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
11137319|NCT01798485|BG002|Baseline|Total|Total of all reporting groups
11137320|NCT01798485|FG000|Participant Flow|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
11137321|NCT01798485|FG001|Participant Flow|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
11137322|NCT01798485|OG000|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
11137323|NCT01798485|OG001|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
11137324|NCT01798485|EG000|Reported Event|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
11137325|NCT01798485|EG001|Reported Event|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
11137326|NCT01798550|BG000|Baseline|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
11137327|NCT01798550|BG001|Baseline|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
11137328|NCT01798550|BG002|Baseline|Total|Total of all reporting groups
11137329|NCT01798550|FG000|Participant Flow|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
11137330|NCT01798550|FG001|Participant Flow|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
11137331|NCT01798550|OG000|Outcome|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
11137332|NCT01798550|OG001|Outcome|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
11137333|NCT01798550|EG000|Reported Event|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
11137334|NCT01798550|EG001|Reported Event|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
11137335|NCT01798589|BG000|Baseline|Ethylenediamine Dihydrochloride|"Arm type: Experimental Ethylenediamine dihydrochloride in methylcellulose 50 mcg/cm2 Ethylenediamine dihydrochloride in polyvinylpyrrolidone 50 mcg/cm2 Methylcellulose (negative control 1) Polyvinylpyrrolidone (negative control 2)~Ethylenediamine dihydrochloride: 1 allergen panel containing 2 allergen and 2 control patches"
11137336|NCT01798589|FG000|Participant Flow|All Subjects|All subjects were patched with 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose), 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and negative controls
11137337|NCT01798589|OG000|Outcome|All Subjects|Subjects were patched with a panel containing 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) vs 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and 2 negative controls
11137338|NCT01798589|OG000|Outcome|All Subjects|All subjects were patched with a single panel containing ethylenediamine dihydrochloride, 50 mcg/cm2 in methylcellulose (MC), ethylenediamine dihydrochloride, 50 mcg/cm2 in polyvinlypyrrolidone (PVP) and 2 negative controls.
11137339|NCT01798589|OG000|Outcome|All Subjects|Tape Irritation, Day 2
11137340|NCT01798589|OG000|Outcome|All Subjects|Itching, Day 2
11137341|NCT01798589|OG000|Outcome|Burning|Subject reported burning at day 2
11137342|NCT01798589|EG000|Reported Event|Ethylenediamine Hydrochloride: Adverse Events|Adverse events reported during clinical trial using investigational products: 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone)
11137343|NCT01798641|BG000|Baseline|Open Shunt, Then Closed|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed."
11137344|NCT01798641|BG001|Baseline|Closed Shunt, Then Open|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks.The closed shunt will be adjusted to open."
11137345|NCT01798641|BG002|Baseline|Total|Total of all reporting groups
11137346|NCT01798641|FG000|Participant Flow|Open Shunt, Then Closed|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed. The closed shunt will be adjusted to open."
11137347|NCT01798641|FG001|Participant Flow|Closed Shunt, Then Open|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed. The closed shunt will be adjusted to open."
11137348|NCT01798641|OG000|Outcome|Open Shunt|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed."
11137349|NCT01798641|OG001|Outcome|Closed Shunt|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The closed shunt will be adjusted to open."
11137350|NCT01798641|OG001|Outcome|Closed Shunt|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks.The closed shunt will be adjusted to open."
11137351|NCT01798641|EG000|Reported Event|Open Shunt|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed."
11137352|NCT01798641|EG001|Reported Event|Closed Shunt|"The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.~MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The closed shunt will be adjusted to open."
11137353|NCT01798706|BG000|Baseline|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
11137354|NCT01798706|BG001|Baseline|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
11137355|NCT01798706|BG002|Baseline|Total|Total of all reporting groups
11137356|NCT01798706|FG000|Participant Flow|Lixisenatide|Lixisenatide 10 mcg subcutaneously once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
11137357|NCT01798706|FG001|Participant Flow|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
11137358|NCT01798706|OG000|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
11137359|NCT01798706|OG001|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
11137360|NCT01798706|EG000|Reported Event|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.(Median exposure: 169 days)
11137361|NCT01798706|EG001|Reported Event|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. (Median exposure: 169 days)
11137362|NCT01798849|BG000|Baseline|Panel A-Healthy|Within each of the 5 rising dose treatment periods, 6 participants received a single dose of MK-8892 0.5 mg, 2.0 mg, 6.0 mg, or 14 mg, and 2 participants received placebo. Dosing periods alternated with Panel B.
11137363|NCT01798849|BG001|Baseline|Panel B-Healthy|Within each of the 4 rising dose treatment periods, 6 participants received a single dose of MK-8892 1.0 mg, 4.0 mg, 9.0 mg or 12 mg, and 2 participants received placebo. Dosing periods alternated with Panel A.
11137364|NCT01798849|BG002|Baseline|Panel C-Mild/Moderate Hypertension|Within each of the 5 single dose treatment periods, 6 participants with mild to moderate hypertension received a single dose of MK-8892 0.5 mg, 1.0 mg, 2.0 mg or 6.0 mg, and 2 participants received placebo. Dosages were determined by the results of Panels A and B.
11137365|NCT01798849|BG003|Baseline|Total|Total of all reporting groups
11137366|NCT01798849|FG000|Participant Flow|Panel A-Healthy|Within each of the 5 rising dose treatment periods, 6 participants received a single dose of MK-8892 0.5 mg, 2.0 mg, 6.0 mg, or 14 mg, and 2 participants received placebo. Dosing periods alternated with Panel B.
11137367|NCT01798849|FG001|Participant Flow|Panel B-Healthy|Within each of the 4 rising dose treatment periods, 6 participants received a single dose of MK-8892 1.0 mg, 4.0 mg, 9.0 mg or 12 mg, and 2 participants received placebo. Dosing periods alternated with Panel A.
11137368|NCT01798849|FG002|Participant Flow|Panel C-Mild/Moderate Hypertension|Within each of the 5 single dose treatment periods, 6 participants with mild to moderate hypertension received a single dose of MK-8892 0.5 mg, 1.0 mg, 2.0 mg or 6.0 mg, and 2 participants received placebo. Dosages were determined by the results of Panels A and B.
11137369|NCT01798849|OG000|Outcome|0.5 mg MK-8892-Healthy|Single oral dose of 0.5 mg MK-8892
11137370|NCT01798849|OG001|Outcome|1.0 mg MK-8892-Healthy|Single oral dose of 1.0 mg MK-8892
11137371|NCT01798849|OG002|Outcome|2.0 mg MK-8892-Healthy (Pooled)|Single oral dose of 2.0 mg MK-8892
11137372|NCT01798849|OG003|Outcome|4.0 mg MK-8892-Healthy|Single oral dose of 4.0 mg MK-8892
11137373|NCT01798849|OG004|Outcome|6.0 mg MK-8892-Healthy|Single oral dose of 6.0 mg MK-8892
11137374|NCT01798849|OG005|Outcome|9.0 mg MK-8892-Healthy|Single oral dose of 9.0 mg MK-8892
11137375|NCT01798849|OG006|Outcome|12.0 mg MK-8892-Healthy|Single oral dose of 12.0 mg MK-8892
11137376|NCT01798849|OG007|Outcome|14.0 mg MK-8892-Healthy|Single oral dose of 14.0 mg MK-8892
11137377|NCT01798849|OG008|Outcome|Placebo-Healthy|Single oral dose of placebo to match MK-8892
11137378|NCT01798849|OG002|Outcome|2.0 mg MK-8892-Healthy|Single oral dose of 2.0 mg MK-8892
11137379|NCT01798849|OG000|Outcome|0.5 mg MK-8892-Hypertensive|Single oral dose of 0.5 mg MK-8892
11137380|NCT01798849|OG001|Outcome|1.0 mg MK-8892-Hypertensive|Single oral dose of 1.0 mg MK-8892
11137381|NCT01798849|OG002|Outcome|2.0 mg MK-8892-Hypertensive|single oral dose of 2.0 mg MK-8892
11137382|NCT01798849|OG003|Outcome|6.0 mg MK-8892-Hypertensive|Single oral dose of 6.0 mg MK-8892. Includes rechallenge
11137383|NCT01798849|OG004|Outcome|Placebo-Hypertensive|Single oral dose of placebo to match MK-8892
11137384|NCT01798849|OG003|Outcome|6.0 mg MK-8892-Hypertensive|Single oral dose of 6.0 mg MK-8892
11137385|NCT01798849|OG004|Outcome|6.0 mg MK-8892-Hypertensive - Rechallenge|Participants who were assigned to 6.0 mg HT group who were administered a rechallenge 6.0 mg dose of MK-8892
11137386|NCT01798849|OG000|Outcome|2.0 mg MK-8892-Healthy-Fasted|Single oral dose of 2.0 mg MK-8892 after an 8-hour fast
11137387|NCT01798849|OG001|Outcome|2.0 mg MK-8892-Healthy-Fed|Single oral dose of 2.0 mg MK-8892 after a high-fat breakfest
11137388|NCT01798849|OG000|Outcome|2.0 mg MK-8892-Healthy -Fasted|Single oral dose of 2.0 mg MK-8892 after an 8-hour fast
11137389|NCT01798849|OG001|Outcome|2.0 Mg MK-8892- Healthy - Fed|single oral dose of 2.0 mg MK-8892 after a high-fat breakfest
11137390|NCT01798849|EG000|Reported Event|0.5 mg MK-8892-Healthy|Single oral dose of 0.5 mg MK-8892
11137391|NCT01798849|EG001|Reported Event|1.0 mg MK-8892-Healthy|Single oral dose of 1.0 mg MK-8892
11137392|NCT01798849|EG002|Reported Event|2.0 mg MK-8892-Healthy (Pooled)|Single oral dose of 2.0 mg MK-8892.
11137393|NCT01798849|EG003|Reported Event|4.0 mg MK-8892-Healthy|Single oral dose of 4.0 mg MK-8892
11137394|NCT01798849|EG004|Reported Event|6.0 mg MK-8892-Healthy|Single oral dose of 6.0 mg MK-8892
11137395|NCT01798849|EG005|Reported Event|9.0 mg MK-8892-Healthy|Single oral dose of 9.0 mg MK-8892
11137396|NCT01798849|EG006|Reported Event|12.0 mg MK-8892-Healthy|Single oral dose of 12.0 mg MK-8892
11137397|NCT01798849|EG007|Reported Event|14.0 mg MK-8892-Healthy|Single oral dose of 14.0 mg MK-8892
11137398|NCT01798849|EG008|Reported Event|Placebo-Healthy|Single oral dose of placebo to match MK-8892
11137399|NCT01798849|EG009|Reported Event|0.5 mg MK-8892-Hypertensive|Single oral dose of 0.5 mg MK-8892
11137400|NCT01798849|EG010|Reported Event|1.0 mg MK-8892-Hypertensive|Single oral dose of 1.0 mg MK-8892
11137401|NCT01798849|EG011|Reported Event|2.0 mg MK-8892-Hypertensive|Single oral dose of 2.0 mg MK-8892
11137402|NCT01798849|EG012|Reported Event|6.0 mg MK-8892-Hypertensive|Single oral dose of 6.0 mg MK-8892. Includes rechallenge
11137403|NCT01798849|EG013|Reported Event|Placebo-Hypertensive|Single oral dose of placebo to match MK-8892
11137404|NCT01798927|BG000|Baseline|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
11137405|NCT01798927|FG000|Participant Flow|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
11137406|NCT01798927|OG000|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
11137407|NCT01798927|EG000|Reported Event|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
11137408|NCT01798966|BG000|Baseline|SENSIMED Triggerfish|All patients included in the device group
11137409|NCT01798966|FG000|Participant Flow|SENSIMED Triggerfish|All patients included in the device group
11137410|NCT01798966|OG000|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
11137411|NCT01798966|OG000|Outcome|SENSIMED Triggerfish|All patients included in the device group
11137412|NCT01798966|EG000|Reported Event|SENSIMED Triggerfish|All patients included in the device group
11137413|NCT01798992|BG000|Baseline|Non-failing Control|Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
11137414|NCT01798992|BG001|Baseline|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
11137415|NCT01798992|BG002|Baseline|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
11137416|NCT01798992|BG003|Baseline|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
11137417|NCT01798992|BG004|Baseline|Total|Total of all reporting groups
11137418|NCT01798992|FG000|Participant Flow|Non-failing Control|Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
11137419|NCT01798992|FG001|Participant Flow|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
11137420|NCT01798992|FG002|Participant Flow|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
11137421|NCT01798992|FG003|Participant Flow|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
11137422|NCT01798992|OG000|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
11137423|NCT01798992|OG001|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months~Metoprolol succinate + doxazosin"
11137424|NCT01798992|OG002|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
11137425|NCT01798992|OG001|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
11137426|NCT01798992|EG000|Reported Event|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
11137427|NCT01798992|EG001|Reported Event|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months~Metoprolol succinate + doxazosin"
11137428|NCT01798992|EG002|Reported Event|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
11137429|NCT01799135|BG000|Baseline|Experimental Arm|"Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most.~DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy.~4D-CT scan 3 months after completing radiotherapy.~DCE-MRI scan~Stereotactic Body Radiation Therapy~4D-CT scan"
11137430|NCT01799135|FG000|Participant Flow|Experimental Arm|"Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most.~DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy.~4D-CT scan 3 months after completing radiotherapy.~DCE-MRI scan~Stereotactic Body Radiation Therapy~4D-CT scan"
11137431|NCT01799135|OG000|Outcome|Experimental Arm|"Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most.~DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy.~4D-CT scan 3 months after completing radiotherapy.~DCE-MRI scan~Stereotactic Body Radiation Therapy~4D-CT scan"
11137432|NCT01799135|EG000|Reported Event|Experimental Arm|"Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most.~DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy.~4D-CT scan 3 months after completing radiotherapy.~DCE-MRI scan~Stereotactic Body Radiation Therapy~4D-CT scan"
11137433|NCT01799213|BG000|Baseline|Placebo|Participants in Placebo (CBT) Arm
11137434|NCT01799213|BG001|Baseline|Meloxicam|Participants in Meloxicam Arm
11137435|NCT01799213|BG002|Baseline|Total|Total of all reporting groups
11137436|NCT01799213|FG000|Participant Flow|Placebo Followed by CBT|"Eligible subjects will be randomized to Meloxicam 15 mg po QD vs placebo~Cognitive Behavioral Therapy (CBT): Subjects originally assigned to placebo will receive cognitive behavioral therapy for 10 weeks"
11137437|NCT01799213|FG001|Participant Flow|Active Treatment With Meloxicam|"Eligible subjects will be randomized to Meloxicam 15 mg po QD vs placebo~Meloxicam 15 mg po QD: Eligible subjects will be take Meloxicam 15 mg po QD"
11137438|NCT01799213|OG000|Outcome|Placebo Followed by CBT|Participants in Placebo (CBT) Arm
11137439|NCT01799213|OG001|Outcome|Meloxicam|Participants in Meloxicam Arm
11137440|NCT01799213|OG000|Outcome|Placebo|Participants in Placebo (CBT) Arm
11137441|NCT01799213|OG000|Outcome|Active Treatment|"Eligible subjects will be randomized to Meloxicam 15 mg po QD vs placebo~Meloxicam 15 mg po QD: Eligible subjects will be take Meloxicam 15 mg po QD"
11137442|NCT01799213|OG001|Outcome|Placebo|"Eligible subjects will be randomized to Meloxicam 15 mg po QD vs placebo~Cognitive Behavioral Therapy: Subjects originally assigned to placebo will receive cognitive behavioral therapy for 10 weeks"
11137443|NCT01799213|OG000|Outcome|Placebo|"Eligible subjects will be randomized to Meloxicam 15 mg po QD vs placebo~Cognitive Behavioral Therapy: Subjects originally assigned to placebo will receive cognitive behavioral therapy for 10 weeks"
11137444|NCT01799213|OG001|Outcome|Active Treatment|"Eligible subjects will be randomized to Meloxicam 15 mg po QD vs placebo~Meloxicam 15 mg po QD: Eligible subjects will be take Meloxicam 15 mg po QD"
11137445|NCT01799213|OG000|Outcome|Active Treatment|"Eligible subjects will be randomized to Meloxicam 15 mg po per day (QD) vs placebo~Meloxicam 15 mg po QD: Eligible subjects will be take Meloxicam 15 mg po QD"
11137446|NCT01799213|EG000|Reported Event|Placebo|Participants in Placebo (CBT) Arm
11137447|NCT01799213|EG001|Reported Event|Meloxicam|Participants in Meloxicam Arm
11137448|NCT01799226|BG000|Baseline|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
11137449|NCT01799226|BG001|Baseline|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
11137450|NCT01799226|BG002|Baseline|Total|Total of all reporting groups
11137451|NCT01799226|FG000|Participant Flow|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
11137452|NCT01799226|FG001|Participant Flow|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
11137453|NCT01799226|OG000|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
11137454|NCT01799226|OG001|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
11137455|NCT01799226|EG000|Reported Event|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
11137456|NCT01799226|EG001|Reported Event|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
11137457|NCT01799239|BG000|Baseline|Overall Study|Describing baseline data for all subjects in the ITT population
11137458|NCT01799239|FG000|Participant Flow|First Test Product; Then SenSura|The subjects tested two products: In the first period the subjects tested the newly developed ostomy bag called Test product. In the second period the subjects tested the comparator SenSura
11137459|NCT01799239|FG001|Participant Flow|First SenSura, Then Test Product|The subjects tested two products: In the first period the subjects tested the comparator SenSura. In the second period the subjects tested the newly developed ostomy bag called Test product
11137460|NCT01799239|OG000|Outcome|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
11137461|NCT01799239|OG001|Outcome|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
11137462|NCT01799239|EG000|Reported Event|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
11137463|NCT01799239|EG001|Reported Event|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
11137464|NCT01799278|BG000|Baseline|All Patients|This is a single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Individual dose reductions will be made on the basis of the AEs observed. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent
11137465|NCT01799278|FG000|Participant Flow|All Patients|MLN8237 at 50 mg twice daily for 7 days repeated every 21 days.
11137466|NCT01799278|OG000|Outcome|All Patients|MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
11137467|NCT01799278|OG000|Outcome|ALL SUBJECTS|A single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days.
11137468|NCT01799278|OG000|Outcome|All Patients|"MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent.~MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water."
11137469|NCT01799278|OG000|Outcome|All Patients|MLN8237 at 50 mg twice daily for 7 days repeated every 21 days.
11137470|NCT01799278|OG000|Outcome|All Patients|This is a single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Individual dose reductions will be made on the basis of the AEs observed. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent
11137471|NCT01799278|EG000|Reported Event|All Patients|"MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent.~MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water."
11137472|NCT01799590|BG000|Baseline|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137473|NCT01799590|BG001|Baseline|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137474|NCT01799590|BG002|Baseline|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137475|NCT01799590|BG003|Baseline|Total|Total of all reporting groups
11137476|NCT01799590|FG000|Participant Flow|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137477|NCT01799590|FG001|Participant Flow|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137478|NCT01799590|FG002|Participant Flow|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137479|NCT01799590|OG000|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137480|NCT01799590|OG001|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11008926|NCT01099111|FG003|Participant Flow|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008927|NCT01099111|FG004|Participant Flow|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008928|NCT01099111|OG000|Outcome|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008929|NCT01099111|OG001|Outcome|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008930|NCT01099111|OG002|Outcome|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008931|NCT01099111|OG003|Outcome|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008932|NCT01099111|OG004|Outcome|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11067013|NCT01394718|OG001|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
11067014|NCT01394718|EG000|Reported Event|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
11137481|NCT01799590|OG002|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137482|NCT01799590|EG000|Reported Event|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137483|NCT01799590|EG001|Reported Event|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11137484|NCT01799590|EG002|Reported Event|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
11149696|NCT01872689|BG002|Baseline|Combination Therapy (Cohort B): Placebo + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11149697|NCT01872689|BG003|Baseline|Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11149698|NCT01872689|BG004|Baseline|Total|Total of all reporting groups
11149699|NCT01872689|FG000|Participant Flow|Monotherapy (Cohort A): Placebo|Participants received monotherapy with placebo matched to lebrikizumab administered via subcutaneous (SC) injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 milligrams (mg) administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11149700|NCT01872689|FG001|Participant Flow|Monotherapy (Cohort A): Lebrikizumab|Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11149701|NCT01872689|FG002|Participant Flow|Combination Therapy (Cohort B): Placebo + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at maximum tolerated dose (MTD) administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11149702|NCT01872689|FG003|Participant Flow|Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11149703|NCT01872689|OG000|Outcome|Monotherapy (Cohort A): Placebo|Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11149704|NCT01872689|OG001|Outcome|Monotherapy (Cohort A): Lebrikizumab|Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11149705|NCT01872689|OG002|Outcome|Combination Therapy (Cohort B): Placebo + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11149706|NCT01872689|OG003|Outcome|Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11149707|NCT01872689|OG000|Outcome|Combination Therapy (Cohort B): Placebo + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11149708|NCT01872689|OG001|Outcome|Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11137485|NCT01799720|BG000|Baseline|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
11137486|NCT01799720|BG001|Baseline|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
11137487|NCT01799720|BG002|Baseline|Only Diet|Participants from group 3 only received the diet. Follow-up 30 days.
11137488|NCT01799720|BG003|Baseline|Total|Total of all reporting groups
11137489|NCT01799720|FG000|Participant Flow|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules a day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
11137490|NCT01799720|FG001|Participant Flow|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules a day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
11137491|NCT01799720|FG002|Participant Flow|Diet|Participants from group 3 took only diet, Follow-up 30 days
11137492|NCT01799720|OG000|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
11137493|NCT01799720|OG001|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
11137494|NCT01799720|OG002|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
11137495|NCT01799720|EG000|Reported Event|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
11137496|NCT01799720|EG001|Reported Event|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
11137497|NCT01799720|EG002|Reported Event|Diet|Participants from group 3 only took diet. Follow-up 30 days.
11137498|NCT01799889|BG000|Baseline|CLL: Entospletinib MM/SDD|Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137499|NCT01799889|BG001|Baseline|FL: Entospletinib MM/SDD|Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137500|NCT01799889|BG002|Baseline|DLBCL: Entospletinib MM/SDD|Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137501|NCT01799889|BG003|Baseline|MCL: Entospletinib MM/SDD|Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137502|NCT01799889|BG004|Baseline|Non-FL iNHL: Entospletinib MM/SDD|Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137503|NCT01799889|BG005|Baseline|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137504|NCT01799889|BG006|Baseline|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137505|NCT01799889|BG007|Baseline|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137506|NCT01799889|BG008|Baseline|CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137507|NCT01799889|BG009|Baseline|CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137508|NCT01799889|BG010|Baseline|CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137509|NCT01799889|BG011|Baseline|CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137510|NCT01799889|BG012|Baseline|Total|Total of all reporting groups
11137511|NCT01799889|FG000|Participant Flow|CLL: Entospletinib MM/SDD|Participants with chronic lymphocytic leukemia (CLL), received original formulation (mono-mesylate [MM]) of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib (spray dried dispersion [SDD]) 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11008933|NCT01099111|EG000|Reported Event|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008934|NCT01099111|EG001|Reported Event|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11067015|NCT01394718|EG001|Reported Event|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
11067016|NCT01394939|BG000|Baseline|Single Agent_ Cohort 1|"JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.~JX-594 3 x 10^8 pfu, Days 1, 8,15, 22, and 29"
11067017|NCT01394939|BG001|Baseline|Single Agent_Cohort 2|"JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.~JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29"
11067018|NCT01394939|BG002|Baseline|Combination_Cohort 3|"JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.~JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9."
11067019|NCT01394939|BG003|Baseline|Combination_Cohort 4|"JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.~JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9."
11067020|NCT01394939|BG004|Baseline|Total|Total of all reporting groups
11067021|NCT01394939|FG000|Participant Flow|Single Agent_ Cohort 1|"JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.~Cohort 1: JX-594 3 x 10^8 pfu, Days 1, 8,15, 22, and 29"
11067022|NCT01394939|FG001|Participant Flow|Single Agent_Cohort 2|"JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.~Cohort 2: JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29"
11067023|NCT01394939|FG002|Participant Flow|Combination_Cohort 3|"JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.~Irinotecan: 180 mg/m2 IV every 2 weeks.~JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9."
11067024|NCT01394939|FG003|Participant Flow|Combination_Cohort 4|"JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.~JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9."
11067025|NCT01394939|OG000|Outcome|Single Agent_ Cohort 1|"JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.~Cohort 1: JX-594 3 x 10^8 pfu, Days 1, 8,15, 22, and 29"
11067026|NCT01394939|OG001|Outcome|Single Agent_Cohort 2|"JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.~JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29"
11067027|NCT01394939|OG002|Outcome|Combination_Cohort 3|"JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.~JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9."
11067028|NCT01394939|OG003|Outcome|Combination_Cohort 4|"JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.~JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9."
11067029|NCT01394939|EG000|Reported Event|Single Agent_ Cohort 1|"JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.~JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)~Cohort 1: Pexa-Vec 3 x 108 pfu, Days 1, 8,15, 22, and 29"
11067030|NCT01394939|EG001|Reported Event|Single Agent_Cohort 2|"JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.~JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)~Cohort 2: Pexa-Vec 3 x 109 pfu, Days 1, 8,15, 22, and 29"
11067031|NCT01394939|EG002|Reported Event|Combination_Cohort 3|"JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.~JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)~Irinotecan: 180 mg/m2 IV every 2 weeks.~Cohort 3: Pexa-Vec 3 x 108 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9."
11008935|NCT01099111|EG002|Reported Event|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008936|NCT01099111|EG003|Reported Event|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008937|NCT01099111|EG004|Reported Event|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
11008938|NCT01099202|BG000|Baseline|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
11008939|NCT01099202|BG001|Baseline|No Procrit|No intervention.
11008940|NCT01099202|BG002|Baseline|Total|Total of all reporting groups
11008941|NCT01099202|FG000|Participant Flow|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
11008942|NCT01099202|FG001|Participant Flow|No Procrit|No intervention.
11008943|NCT01099202|OG000|Outcome|Procrit|Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.
11008944|NCT01099202|OG001|Outcome|No Procrit|No intervention.
11008945|NCT01099202|OG000|Outcome|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
11008946|NCT01099202|EG000|Reported Event|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
11008947|NCT01099202|EG001|Reported Event|No Procrit|No intervention.
11008948|NCT01099215|BG000|Baseline|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
11008949|NCT01099215|BG001|Baseline|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
11008950|NCT01099215|BG002|Baseline|Total|Total of all reporting groups
11008951|NCT01099215|FG000|Participant Flow|Low Dose PVS-10200 (Cohort A)|Low dose PVS-10200 (6×10^5 cells/cm lesion)
11008952|NCT01099215|FG001|Participant Flow|High Dose PVS-10200 (Cohort B)|High dose PVS-10200 (15×10^5 cells/cm lesion)
11008953|NCT01099215|OG000|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
11008954|NCT01099215|OG001|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
11008955|NCT01099215|EG000|Reported Event|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
11008956|NCT01099215|EG001|Reported Event|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
11008957|NCT01099267|BG000|Baseline|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
11008958|NCT01099267|FG000|Participant Flow|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
11008959|NCT01099267|OG000|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
11008960|NCT01099267|EG000|Reported Event|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
11137512|NCT01799889|FG001|Participant Flow|FL: Entospletinib MM/SDD|Participants with follicular lymphoma (FL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137513|NCT01799889|FG002|Participant Flow|DLBCL: Entospletinib MM/SDD|Participants with diffuse large B-cell lymphoma (DLBCL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137514|NCT01799889|FG003|Participant Flow|MCL: Entospletinib MM/SDD|Participants with mantle cell lymphoma (MCL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137515|NCT01799889|FG004|Participant Flow|Non-FL iNHL: Entospletinib MM/SDD|Participants with non-FL indolent non-Hodgkin lymphomas (iNHL), (ie, participants with lymphoplasmacytoid lymphoma/ waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma [MZL]), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137516|NCT01799889|FG005|Participant Flow|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg|Participants with CLL, who were prior B-cell receptor (BCR) inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137517|NCT01799889|FG006|Participant Flow|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137518|NCT01799889|FG007|Participant Flow|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137519|NCT01799889|FG008|Participant Flow|CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to Bruton tyrosine kinase (BTK) inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137520|NCT01799889|FG009|Participant Flow|CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to phosphatidylinositol 3-kinase (PI3K) inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137521|NCT01799889|FG010|Participant Flow|CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137522|NCT01799889|FG011|Participant Flow|CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137523|NCT01799889|OG000|Outcome|DLBCL: Entospletinib MM/SDD|Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137524|NCT01799889|OG001|Outcome|MCL: Entospletinib MM/SDD|Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137525|NCT01799889|OG002|Outcome|CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137526|NCT01799889|OG003|Outcome|CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137527|NCT01799889|OG004|Outcome|CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137528|NCT01799889|OG005|Outcome|CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137529|NCT01799889|OG000|Outcome|CLL: Entospletinib MM/SDD|Participants with CLL received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11008961|NCT01099358|BG000|Baseline|All Participants (All Participants (Group A, B, C and D)|"A:Cycle1:100mg/m² cisplatin(cs) I.V on week(w)1,day(d)1. 5-FU as a 96-hour(h) C.I. of 1000 mg/m²/d starting (st) on w 1,d 1-4.~400mg/m² cetuximab(ct) I.V on w 2,d 1.250mg/m² ct I.V on w 3,d 1.Cycle 2+100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.250mg/m² ct I.V on w 1-3,d 1.~B:Cycle1:400mg/m² ct I.V on w 1,d 1.250mg/m² ct I.V on w 2&3,d 1.Cycle 2:100mg/m² cs I.V on w 1, d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1- 4.250mg/m² ct I.V on w 1-3,d 1.Cycle 3 +:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.~250mg/m² ct I.V on w 1-3,d 1. C:Cycle1:100mg/m² cs I.V on w 1, d 1. 5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1.400 mg/m² ct I.V on w 2,d 1.250mg/m² ct I.V on w 3&4,d 1.Cycle2-6:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1. 250mg/m² ct I.V w 1,2,&3,d 1.~D:Cycle1:400mg/m² ct I.V w 1,d 1.100mg/m² cs I.V w 1,d 1.Optional 5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1."
11008962|NCT01099358|FG000|Participant Flow|Cisplatin on Cetuximab (A)|"Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
11008963|NCT01099358|FG001|Participant Flow|Cetuximab on Cisplatin (B)|"Cycle 1:~400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
11008964|NCT01099358|FG002|Participant Flow|Cetuximab and Cisplatin (C)|"Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
11008965|NCT01099358|FG003|Participant Flow|Cetuximab and Cisplatin (D)|"Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.~After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
11008966|NCT01099358|OG000|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
11008967|NCT01099358|OG001|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
11067032|NCT01394939|EG003|Reported Event|Combination_Cohort 4|"JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.~JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)~Cohort 4: Pexa-Vec 1 x 109 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9."
11067033|NCT01394952|BG000|Baseline|Placebo|Placebo was administered once weekly, subcutaneously
11067034|NCT01394952|BG001|Baseline|Dulaglutide|1.5 mg Dulaglutide was administered once weekly, subcutaneously
11067035|NCT01394952|BG002|Baseline|Total|Total of all reporting groups
11008968|NCT01099358|OG000|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
11008969|NCT01099358|OG001|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
11008970|NCT01099358|OG000|Outcome|Cetuximab (D)|"Cetuximab and Cisplatin (D)~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1."
11008971|NCT01099358|EG000|Reported Event|Cisplatin on Cetuximab (A)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
11008972|NCT01099358|EG001|Reported Event|Cetuximab on Cisplatin (B)|"Cetuximab on Cisplatin (B)~Cycle 1:~400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
11008973|NCT01099358|EG002|Reported Event|Cetuximab and Cisplatin (C)|"Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
11008974|NCT01099358|EG003|Reported Event|Cetuximab and Cisplatin (D)|"Cetuximab and Cisplatin (D)~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.~After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
11008975|NCT01099397|BG000|Baseline|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study
11008976|NCT01099397|FG000|Participant Flow|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study; participants enrolled were evaluated at three time points as part of the PEAR protocol, at baseline, 9 weeks and 18 weeks; for each participant at each time point, a fasting glucose value and 2-hour oral glucose tolerance test value was collected and compared
11008977|NCT01099397|OG000|Outcome|2-hour Glucose|Glucose collected after a 2 hour oral glucose tolerance test
11008978|NCT01099397|OG001|Outcome|Fasting Glucose|Fasting glucose collected
11008979|NCT01099397|EG000|Reported Event|PEAR Sub-study Participants|All participants in the PEAR sub-study were evaluated by two methods at 3 time-points in the PEAR parent study
11067036|NCT01394952|FG000|Participant Flow|Placebo|Placebo was administered once weekly, subcutaneously
11008980|NCT01099449|BG000|Baseline|Calcium Gluconate + Magnesium Sulfate (Pre and Post)|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>>~>> calcium gluconate: Given IV>>~>> magnesium sulfate: Given IV>>~>> oxaliplatin"
11008981|NCT01099449|BG001|Baseline|Placebo (Pre and Post)|"Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> placebo: Given IV>>~>> oxaliplatin"
11008982|NCT01099449|BG002|Baseline|Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> calcium gluconate: Given IV>>~>> magnesium sulfate: Given IV>>~>> placebo: Given IV>>~>>~>>~>>> oxaliplatin"
11008983|NCT01099449|BG003|Baseline|Total|Total of all reporting groups
11008984|NCT01099449|FG000|Participant Flow|Calcium Gluconate + Magnesium Sulfate (Pre and Post)|Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
11008985|NCT01099449|FG001|Participant Flow|Placebo (Pre and Post)|Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
11008986|NCT01099449|FG002|Participant Flow|Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)|Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
11008987|NCT01099449|OG000|Outcome|Calcium Gluconate + Magnesium Sulfate (Pre and Post)|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>~>>~>~>> calcium gluconate: Given IV>~>>~>~>> magnesium sulfate: Given IV>~>>~>~>> oxaliplatin"
11008988|NCT01099449|OG001|Outcome|Placebo (Pre and Post)|"Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).> >>~>~>> placebo: Given IV>~>>~>~>> oxaliplatin"
11008989|NCT01099449|OG002|Outcome|Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).> >>~>~>> calcium gluconate: Given IV>~>>~>~>> magnesium sulfate: Given IV>~>>~>~>> placebo: Given IV>~>>~>~>> oxaliplatin"
11008990|NCT01099449|OG000|Outcome|Calcium Gluconate + Magnesium Sulfate (Pre and Post)|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>>~>> calcium gluconate: Given IV>>~>> magnesium sulfate: Given IV>>~>> oxaliplatin"
11008991|NCT01099449|OG001|Outcome|Placebo (Pre and Post)|"Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> placebo: Given IV>>~>> oxaliplatin"
11008992|NCT01099449|OG002|Outcome|Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> calcium gluconate: Given IV>>~>> magnesium sulfate: Given IV>>~>> placebo: Given IV>>~>> oxaliplatin"
11008993|NCT01099449|OG000|Outcome|Calcium Gluconate + Magnesium Sulfate (Pre and Post)|Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
11008994|NCT01099449|OG001|Outcome|Placebo (Pre and Post)|Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
11008995|NCT01099449|OG002|Outcome|Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)|Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
11008996|NCT01099449|OG000|Outcome|Calcium Gluconate + Magnesium Sulfate (Pre and Post)|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >>~calcium gluconate: Given IV >>~magnesium sulfate: Given IV >>~oxaliplatin"
11008997|NCT01099449|OG000|Outcome|Arm I|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>~>>~>~>> calcium gluconate: Given IV>~>>~>~>> magnesium sulfate: Given IV>~>>~>~>> oxaliplatin"
11008998|NCT01099449|OG001|Outcome|Arm II|"Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).> >>~>~>> placebo: Given IV>~>>~>~>> oxaliplatin"
11008999|NCT01099449|OG002|Outcome|Arm III|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).> >>~>~>> calcium gluconate: Given IV>~>>~>~>> magnesium sulfate: Given IV>~>>~>~>> placebo: Given IV>~>>~>~>> oxaliplatin"
11009000|NCT01099449|OG000|Outcome|Arm I|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>>~>> calcium gluconate: Given IV>>~>> magnesium sulfate: Given IV>>~>> oxaliplatin"
11009001|NCT01099449|OG001|Outcome|Arm II|"Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> placebo: Given IV>>~>> oxaliplatin"
11009002|NCT01099449|OG002|Outcome|Arm III|"Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> calcium gluconate: Given IV>>~>> magnesium sulfate: Given IV>>~>> placebo: Given IV>>~>> oxaliplatin"
11009003|NCT01099449|EG000|Reported Event|Calcium Gluconate + Magnesium Sulfate (Pre and Post)|oxaliplatin
11137530|NCT01799889|OG001|Outcome|FL: Entospletinib MM/SDD|Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137531|NCT01799889|OG002|Outcome|Non-FL iNHL: Entospletinib MM/SDD|Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137532|NCT01799889|OG003|Outcome|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137533|NCT01799889|OG004|Outcome|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137534|NCT01799889|OG005|Outcome|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137535|NCT01799889|OG000|Outcome|CLL: Entospletinib MM/SDD|Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137536|NCT01799889|OG002|Outcome|DLBCL: Entospletinib MM/SDD|Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137537|NCT01799889|OG003|Outcome|MCL: Entospletinib MM/SDD|Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137538|NCT01799889|OG004|Outcome|Non-FL iNHL: Entospletinib MM/SDD|Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137539|NCT01799889|OG005|Outcome|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137540|NCT01799889|OG006|Outcome|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137541|NCT01799889|OG007|Outcome|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137542|NCT01799889|OG008|Outcome|CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137543|NCT01799889|OG009|Outcome|CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137544|NCT01799889|OG010|Outcome|CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137545|NCT01799889|OG011|Outcome|CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137546|NCT01799889|EG000|Reported Event|CLL: Entospletinib MM/SDD|Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137547|NCT01799889|EG001|Reported Event|FL: Entospletinib MM/SDD|Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137548|NCT01799889|EG002|Reported Event|DLBCL: Entospletinib MM/SDD|Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11009004|NCT01099449|EG001|Reported Event|Placebo (Pre and Post)|oxaliplatin
11009005|NCT01099449|EG002|Reported Event|Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)|oxaliplatin
11009006|NCT01099475|BG000|Baseline|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
11009007|NCT01099475|BG001|Baseline|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
11009008|NCT01099475|BG002|Baseline|Total|Total of all reporting groups
11009009|NCT01099475|FG000|Participant Flow|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
11009010|NCT01099475|FG001|Participant Flow|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
11009011|NCT01099475|OG000|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
11009012|NCT01099475|OG001|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
11009013|NCT01099475|EG000|Reported Event|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
11009014|NCT01099475|EG001|Reported Event|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
11009015|NCT01099579|BG000|Baseline|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
11009016|NCT01099579|BG001|Baseline|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
11009017|NCT01099579|BG002|Baseline|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
11009018|NCT01099579|BG003|Baseline|Total|Total of all reporting groups
11067037|NCT01394952|FG001|Participant Flow|Dulaglutide|1.5 mg Dulaglutide was administered once weekly, subcutaneously
11067038|NCT01394952|OG000|Outcome|Placebo|Placebo was administered once weekly, subcutaneously
11137549|NCT01799889|EG003|Reported Event|MCL: Entospletinib MM/SDD|Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137550|NCT01799889|EG004|Reported Event|Non-FL iNHL: Entospletinib MM/SDD|Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137551|NCT01799889|EG005|Reported Event|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137552|NCT01799889|EG006|Reported Event|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137553|NCT01799889|EG007|Reported Event|CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg|Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137554|NCT01799889|EG008|Reported Event|CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137555|NCT01799889|EG009|Reported Event|CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137556|NCT01799889|EG010|Reported Event|CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137557|NCT01799889|EG011|Reported Event|CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD|Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
11137558|NCT01799941|BG000|Baseline|Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg|Participants who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137559|NCT01799941|FG000|Participant Flow|Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg|Participants who received fixed-dose combination of 20 milligram (mg) dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137560|NCT01799941|OG000|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
10887285|NCT00499616|OG002|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11137561|NCT01799941|OG001|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137562|NCT01799941|OG002|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137563|NCT01799941|OG003|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137564|NCT01799941|EG000|Reported Event|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137565|NCT01799941|EG001|Reported Event|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137566|NCT01799941|EG002|Reported Event|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137567|NCT01799941|EG003|Reported Event|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
11137568|NCT01799993|BG000|Baseline|Amikacin Inhale (BAY41-6551)|Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.
11137569|NCT01799993|BG001|Baseline|Placebo|Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.
11137570|NCT01799993|BG002|Baseline|Total|Total of all reporting groups
11137571|NCT01799993|FG000|Participant Flow|Amikacin Inhale (BAY41-6551)|Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.
11137572|NCT01799993|FG001|Participant Flow|Placebo|Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.
11137573|NCT01799993|OG000|Outcome|Amikacin Inhale (BAY41-6551)|Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.
11137574|NCT01799993|OG001|Outcome|Placebo|Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.
11137575|NCT01799993|EG000|Reported Event|Amikacin Inhale 400mg q12h|Patients received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via PDDS Clinical from Day 1 to Day 10.
11137576|NCT01799993|EG001|Reported Event|Placebo|Patients received 3.2 mL placebo solution aerosolized every 12 hours via PDDS Clinical from Day 1 to Day 10.
11137577|NCT01800058|BG000|Baseline|CTCs Analysis|"Prospective analysis of biologic samples from PB of 65 patients with localized high-risk PCa (NCCN 2011) treated with RTC-3D-IMRT combined with ADT. Following the sign of the informed consent of the patient, the blood samples will be analyzed for CTCs using an immunomagnetic method based on the CellSearch system in 4 periods of time:~Prior to any treatment (baseline- Time 1)~Following ADT and prior to RT (Time 2)~Following the end of RT (1-3 months afterwards) (Time 3)~Following 9 -12 after RT in those cases in cases of one turn (+) in CTCs in the 2nd or 3rd determination"
11137578|NCT01800058|FG000|Participant Flow|Circulating Prostatic Tumor Cells in the Peripheral Blood|"Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):~prior to any treatment;~following AD and prior to RT; and~following the end of RT (1-3 months afterwards).~The quantification of CTC in blood samples will be done with the CellSearch® system."
11137579|NCT01800058|OG000|Outcome|Circulating Prostatic Tumor Cells in the Peripheral Blood|"Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):~prior to any treatment;~following AD and prior to RT; and~following the end of RT (1-3 months afterwards).~six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination~The quantification of CTC in blood samples will be done with the CellSearch® system."
11137580|NCT01800058|OG000|Outcome|Circulating Prostatic Tumor Cells in the Peripheral Blood|"Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):~prior to any treatment;~following AD and prior to RT; and~following the end of RT (1-3 months afterwards).~The quantification of CTC in blood samples will be done with the CellSearch® system."
11137581|NCT01800058|EG000|Reported Event|Circulating Prostatic Tumor Cells in the Peripheral Blood|"Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):~prior to any treatment;~following AD and prior to RT; and~following the end of RT (1-3 months afterwards).~The quantification of CTC in blood samples will be done with the CellSearch® system."
11137582|NCT01800201|BG000|Baseline|Control|The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.
11137583|NCT01800201|BG001|Baseline|Intervention|"The intervention group (1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will be assigned an engagement advisor from the study team; (3) asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; and (5) will determine their preferences for Way to Health platform communication methods during the study.~The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment."
11137584|NCT01800201|BG002|Baseline|Total|Total of all reporting groups
11137585|NCT01800201|FG000|Participant Flow|Control|The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.
11137586|NCT01800201|FG001|Participant Flow|Intervention|"The intervention group (1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will be assigned an engagement advisor from the study team; (3) asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; and (5) will determine their preferences for Way to Health platform communication methods during the study.~The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment."
11137587|NCT01800201|OG000|Outcome|Control|The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.
11149709|NCT01872689|OG000|Outcome|Monotherapy (Cohort A): Lebrikizumab|Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11137588|NCT01800201|OG001|Outcome|Intervention|The intervention group (1) will use GlowCaps, a remote monitoring and reminder pill bottle; (2) assigned an engagement advisor from the study team; (3) asked to provide study team with names and contact information of up to 3 family members or friends as support partners for med adherence. The study team will contact these people in order listed until 1 agrees to this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on med adherence; and (5) will determine preferences for Way to Health platform communication methods.The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
11137589|NCT01800201|OG001|Outcome|Intervention|"The intervention group (1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will be assigned an engagement advisor from the study team; (3) asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; and (5) will determine their preferences for Way to Health platform communication methods during the study.~The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment."
11137590|NCT01800201|EG000|Reported Event|Control|The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.
11137591|NCT01800201|EG001|Reported Event|Intervention|"The intervention group (1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will be assigned an engagement advisor from the study team; (3) asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; and (5) will determine their preferences for Way to Health platform communication methods during the study.~The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment."
11137592|NCT01800318|BG000|Baseline|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
11137593|NCT01800318|BG001|Baseline|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs. at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
11137594|NCT01800318|BG002|Baseline|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
11137595|NCT01800318|BG003|Baseline|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
11137596|NCT01800318|BG004|Baseline|Total|Total of all reporting groups
11149710|NCT01872689|EG000|Reported Event|Monotherapy (Cohort A): Placebo|Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11009019|NCT01099579|FG000|Participant Flow|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
11009020|NCT01099579|FG001|Participant Flow|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
11009021|NCT01099579|FG002|Participant Flow|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
11009022|NCT01099579|OG000|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
11009023|NCT01099579|OG001|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
11009024|NCT01099579|OG002|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
11009025|NCT01099579|OG000|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
11009026|NCT01099579|OG001|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
11009027|NCT01099579|EG000|Reported Event|B/L Weight 5 to Less Than 10 kg|
11009028|NCT01099579|EG001|Reported Event|B/L Weight 10 to Less Than 15 kg|
11009029|NCT01099579|EG002|Reported Event|B/L Weight 15 to Less Than 25 kg|
11009030|NCT01099618|BG000|Baseline|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11067039|NCT01394952|OG001|Outcome|Dulaglutide|1.5 mg Dulaglutide was administered once weekly, subcutaneously
11067040|NCT01394952|EG000|Reported Event|Placebo|Placebo was administered once weekly, subcutaneously
11067041|NCT01394952|EG001|Reported Event|Dulaglutide|1.5 mg Dulaglutide was administered once weekly, subcutaneously
11067042|NCT01394978|BG000|Baseline|Control|"No treatment.~Control: Standard surgical techniques including staples and sutures."
11009031|NCT01099618|BG001|Baseline|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009032|NCT01099618|BG002|Baseline|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009033|NCT01099618|BG003|Baseline|Total|Total of all reporting groups
11009034|NCT01099618|FG000|Participant Flow|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009035|NCT01099618|FG001|Participant Flow|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009036|NCT01099618|FG002|Participant Flow|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009037|NCT01099618|OG000|Outcome|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009038|NCT01099618|OG001|Outcome|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009039|NCT01099618|OG002|Outcome|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009040|NCT01099618|EG000|Reported Event|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11137597|NCT01800318|FG000|Participant Flow|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
11137598|NCT01800318|FG001|Participant Flow|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
11137599|NCT01800318|FG002|Participant Flow|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
11137600|NCT01800318|FG003|Participant Flow|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
11137601|NCT01800318|OG000|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
11137602|NCT01800318|OG001|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
11137603|NCT01800318|OG002|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
11149711|NCT01872689|EG001|Reported Event|Monotherapy (Cohort A): Lebrikizumab|Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
11137604|NCT01800318|OG003|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
11137605|NCT01800318|OG001|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
11137606|NCT01800318|OG002|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
11137607|NCT01800318|OG001|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
11137608|NCT01800318|OG002|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
11137609|NCT01800318|EG000|Reported Event|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
11137610|NCT01800318|EG001|Reported Event|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
11149712|NCT01872689|EG002|Reported Event|Combination Therapy (Cohort B): Placebo + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11009041|NCT01099618|EG001|Reported Event|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009042|NCT01099618|EG002|Reported Event|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
11009043|NCT01099631|BG000|Baseline|Salmonella Typhimurium 10 to the 5 th - Level 1|Patients received Level 1 = 10^5th dose of Salmonella typhimurium
11009044|NCT01099631|BG001|Baseline|Salmonella Typhimurium 10 to the 6 th - Level 2|Patients received Level 2 = 10^6th dose of Salmonella typhimurium
11009045|NCT01099631|BG002|Baseline|Salmonella Typhimurium 10 to the 7 th - Level 3|Patients received Level 3 = 10^7th dose of Salmonella typhimurium
11009046|NCT01099631|BG003|Baseline|Salmonella Typhimurium 10 to the 8 th - Level 4|Patients received Level 4 = 10^8th dose of Salmonella typhimurium
11009047|NCT01099631|BG004|Baseline|Salmonella Typhimurium 10 to the 9 th - Level 5|Patients received Level 5 = 10^9th dose of Salmonella typhimurium
11009048|NCT01099631|BG005|Baseline|Salmonella Typhimurium 10 to the 10 th - Level 6|Patients received Level 6 = 10^10th dose of Salmonella typhimurium
11009049|NCT01099631|BG006|Baseline|Total|Total of all reporting groups
11009050|NCT01099631|FG000|Participant Flow|Salmonella Typhimurium 10 to the 5 th - Level 1|Patients received Level 1 = 10^5 dose of of Salmonella typhimurium
11009051|NCT01099631|FG001|Participant Flow|Salmonella Typhimurium 10 to the 6 th - Level 2|Patients received Level 2 = 10^6th dose of Salmonella typhimurium
11009052|NCT01099631|FG002|Participant Flow|Salmonella Typhimurium 10 to the 7 th - Level 3|Patients received Level 3 = 10^7th dose of Salmonella typhimurium
11009053|NCT01099631|FG003|Participant Flow|Salmonella Typhimurium 10 to the 8 th - Level 4|Patients received Level 4 = 10^7th dose of Salmonella typhimurium
11009054|NCT01099631|FG004|Participant Flow|Salmonella Typhimurium 10 to the 9th - Level 5|Patients received Level 5 = 10^9th dose of Salmonella typhimurium
11009055|NCT01099631|FG005|Participant Flow|Salmonella Typhimurium 10 to the 10 th - Level 6|Patients received Level 6 = 10^10th dose of Salmonella typhimurium
11009056|NCT01099631|OG000|Outcome|Salmonella Typhimurium 10 to the 5 th - Level 1|Patients received Level 1 = 10^5th dose of Salmonella typhimurium
11009057|NCT01099631|OG001|Outcome|Salmonella Typhimurium 10 to the 6 th - Level 2|Patients received Level 2 = 10^6th dose of Salmonella typhimurium
11009058|NCT01099631|OG002|Outcome|Salmonella Typhimurium 10 to the 7 th - Level 3|Patients received Level 3 = 10^7th dose of Salmonella typhimurium
11009059|NCT01099631|OG003|Outcome|Salmonella Typhimurium 10 to the 8 th - Level 4|Patients received Level 4 = 10^8th dose of Salmonella typhimurium
11009060|NCT01099631|OG004|Outcome|Salmonella Typhimurium 10 to the 9th - Level 5|Patients received Level 5 = 10^9th dose of Salmonella typhimurium
11009061|NCT01099631|OG005|Outcome|Salmonella Typhimurium 10 to the 10 th - Level 6|Patients received Level 6 = 10^10th dose of Salmonella typhimurium
11009062|NCT01099631|OG003|Outcome|Salmonella Typhimurium 10 to the 8 th - Level 4|Patients received Level 4 = 10^8 th dose of Salmonella typhimurium
11009063|NCT01099631|OG005|Outcome|Salmonella Typhimurium 10 to the 10 th - Level 6|Patients received Level 1 = 10^10 th dose of Salmonella typhimurium
11009064|NCT01099631|OG001|Outcome|Salmonella Typhimurium 10 to the 6 th - Level 2|Patients received Level 2 = 10^6 th dose of Salmonella typhimurium
11009065|NCT01099631|OG002|Outcome|Salmonella Typhimurium 10 to the 7 th - Level 3|Patients received Level 3 = 10^7 th dose of Salmonella typhimurium
11009066|NCT01099631|OG004|Outcome|Salmonella Typhimurium 10 to the 9th - Level 5|Patients received Level 5 = 10^10 th dose of Salmonella typhimurium
11009067|NCT01099631|OG005|Outcome|Salmonella Typhimurium 10 to the 10 th - Level 6|Patients received Level 6 = 10^10 th dose of Salmonella typhimurium
11009068|NCT01099631|EG000|Reported Event|Salmonella Typhimurium 10 to the 5 th - Level 1|Patients received Level 1 = 10^5th dose of Salmonella typhimurium
11009069|NCT01099631|EG001|Reported Event|Salmonella Typhimurium 10 to the 6 th - Level 2|Patients received Level 2 = 10^6th dose of Salmonella typhimurium
11009070|NCT01099631|EG002|Reported Event|Salmonella Typhimurium 10 to the 7 th - Level 3|Patients received Level 3 = 10^7th dose of Salmonella typhimurium
11009071|NCT01099631|EG003|Reported Event|Salmonella Typhimurium 10 to the 8 th - Level 4|Patients received Level 4 = 10^8th dose of Salmonella typhimurium
11009072|NCT01099631|EG004|Reported Event|Salmonella Typhimurium 10 to the 9 th - Level 5|Patients received Level 5 = 10^9th dose of Salmonella typhimurium
11009073|NCT01099631|EG005|Reported Event|Salmonella Typhimurium 10 to the 10 th - Level 6|Patients received Level 6 = 10^10th dose of Salmonella typhimurium
11009074|NCT01099709|BG000|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
11009075|NCT01099709|FG000|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
11149713|NCT01872689|EG003|Reported Event|Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone|Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
11009076|NCT01099709|FG001|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
11009077|NCT01099709|OG000|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009078|NCT01099709|OG001|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009079|NCT01099709|OG000|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dosed administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009080|NCT01099709|EG000|Reported Event|Reformulated OXY 10-mg Tablet (Fed)|Reformulated OXY 10-mg tablet (fed) x 1 dose
11009081|NCT01099709|EG001|Reported Event|Original OxyContin® (OXY) 10-mg Tablet (Fed)|Original OxyContin® (OXY) 10-mg tablet (fed) x 1 dose
11009082|NCT01099761|BG000|Baseline|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
11009083|NCT01099761|BG001|Baseline|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
11009084|NCT01099761|BG002|Baseline|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
11009085|NCT01099761|BG003|Baseline|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
11009086|NCT01099761|BG004|Baseline|Total|Total of all reporting groups
11009087|NCT01099761|FG000|Participant Flow|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
11009088|NCT01099761|FG001|Participant Flow|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
11009089|NCT01099761|FG002|Participant Flow|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
11009090|NCT01099761|FG003|Participant Flow|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
11009091|NCT01099761|OG000|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
11009092|NCT01099761|OG001|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
11009093|NCT01099761|OG002|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
11009094|NCT01099761|EG000|Reported Event|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
11009095|NCT01099761|EG001|Reported Event|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
11009096|NCT01099761|EG002|Reported Event|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
11009097|NCT01099761|EG003|Reported Event|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
11009098|NCT01099774|BG000|Baseline|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
11009099|NCT01099774|BG001|Baseline|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
11009100|NCT01099774|BG002|Baseline|Total|Total of all reporting groups
11009101|NCT01099774|FG000|Participant Flow|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
11009102|NCT01099774|FG001|Participant Flow|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
11009103|NCT01099774|OG000|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
11009104|NCT01099774|OG001|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
11009105|NCT01099774|EG000|Reported Event|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
11009106|NCT01099774|EG001|Reported Event|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
11009107|NCT01099917|BG000|Baseline|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
11009108|NCT01099917|FG000|Participant Flow|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
11009109|NCT01099917|OG000|Outcome|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
11009110|NCT01099917|EG000|Reported Event|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
11009111|NCT01099969|BG000|Baseline|GlideScope With Non-styletted Endotrol ETT|"The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).~GlideScope videolaryngoscope~Non-styletted Endotrol endotracheal tube (ETT)"
11009112|NCT01099969|BG001|Baseline|GlideScope With Styletted Regular ETT|"The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.~GlideScope videolaryngoscope~Regular endotracheal tube (ETT) with GlideRite stylet"
11009113|NCT01099969|BG002|Baseline|McGrath With Non-styletted Endotrol ETT|"The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).~McGrath videolaryngoscope~Non-styletted Endotrol endotracheal tube (ETT)"
11009114|NCT01099969|BG003|Baseline|McGrath With With Styletted Regular ETT|"The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.~McGrath videolaryngoscope~Regular endotracheal tube (ETT) with GlideRite stylet"
11009115|NCT01099969|BG004|Baseline|Total|Total of all reporting groups
11009116|NCT01099969|FG000|Participant Flow|GlideScope With Non-styletted Endotrol ETT|"The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).~GlideScope videolaryngoscope~Non-styletted Endotrol endotracheal tube (ETT)"
11009117|NCT01099969|FG001|Participant Flow|GlideScope With Styletted Regular ETT|"The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.~GlideScope videolaryngoscope~Regular endotracheal tube (ETT) with GlideRite stylet"
11009118|NCT01099969|FG002|Participant Flow|McGrath With Non-styletted Endotrol ETT|"The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).~McGrath videolaryngoscope~Non-styletted Endotrol endotracheal tube (ETT)"
11009119|NCT01099969|FG003|Participant Flow|McGrath With With Styletted Regular ETT|"The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.~McGrath videolaryngoscope~Regular endotracheal tube (ETT) with GlideRite stylet"
11009120|NCT01099969|OG000|Outcome|GlideScope With Non-styletted Endotrol ETT|"The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).~GlideScope videolaryngoscope~Non-styletted Endotrol endotracheal tube (ETT)"
11009121|NCT01099969|OG001|Outcome|GlideScope With Styletted Regular ETT|"The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.~GlideScope videolaryngoscope~Regular endotracheal tube (ETT) with GlideRite stylet"
11009122|NCT01099969|OG002|Outcome|McGrath With Non-styletted Endotrol ETT|"The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).~McGrath videolaryngoscope~Non-styletted Endotrol endotracheal tube (ETT)"
11009123|NCT01099969|OG003|Outcome|McGrath With With Styletted Regular ETT|"The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.~McGrath videolaryngoscope~Regular endotracheal tube (ETT) with GlideRite stylet"
11009124|NCT01099969|EG000|Reported Event|GlideScope With Non-styletted Endotrol ETT|"The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).~GlideScope videolaryngoscope~Non-styletted Endotrol endotracheal tube (ETT)"
11149714|NCT01872715|BG000|Baseline|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
11009125|NCT01099969|EG001|Reported Event|GlideScope With Styletted Regular ETT|"The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.~GlideScope videolaryngoscope~Regular endotracheal tube (ETT) with GlideRite stylet"
11009126|NCT01099969|EG002|Reported Event|McGrath With Non-styletted Endotrol ETT|"The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).~McGrath videolaryngoscope~Non-styletted Endotrol endotracheal tube (ETT)"
11149715|NCT01872715|FG000|Participant Flow|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
11009127|NCT01099969|EG003|Reported Event|McGrath With With Styletted Regular ETT|"The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.~McGrath videolaryngoscope~Regular endotracheal tube (ETT) with GlideRite stylet"
11009128|NCT01100034|BG000|Baseline|Etanercept|Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
11009129|NCT01100034|FG000|Participant Flow|Etanercept|Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
11009130|NCT01100034|OG000|Outcome|Etanercept|Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
11009131|NCT01100034|EG000|Reported Event|Etanercept|Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
11009132|NCT01100073|BG000|Baseline|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
11009133|NCT01100073|FG000|Participant Flow|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use. The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
11009134|NCT01100073|OG000|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
11009135|NCT01100073|EG000|Reported Event|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
11149716|NCT01872715|OG000|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
11137611|NCT01800318|EG002|Reported Event|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
11137612|NCT01800318|EG003|Reported Event|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
11137613|NCT01800786|BG000|Baseline|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
11137614|NCT01800786|BG001|Baseline|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
11137615|NCT01800786|BG002|Baseline|Total|Total of all reporting groups
11137616|NCT01800786|FG000|Participant Flow|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
11137617|NCT01800786|FG001|Participant Flow|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
11348789|NCT04147611|BG001|Baseline|Normal Hearing Controls|"The normal hearing controls will be limited to 15 adults.~Participants will be tested separately on the six following conditions:~Unaided~Unilateral hearing aid with contralateral plug.~Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)~Bone Conduction Device (BAHA) only~BAHA + Wireless Audio-Streaming Accessory~BAHA + Digital Adaptive RM System~BAHA: Participant's pediatric bone conduction hearing device.~Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.~Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.~Hearing Aid: Participant's unilateral hearing aid with contralateral plug."
11348790|NCT04147611|BG002|Baseline|Total|Total of all reporting groups
11348791|NCT04147611|FG000|Participant Flow|Remote Microphone (RM) Technology Group|"The RM technology group will limited to the pediatrics participants.~Participants will be tested separately on the three following conditions:~Bone Conduction Device (BAHA) only~BAHA + Wireless Audio-Streaming Accessory~BAHA + Digital Adaptive RM System~BAHA: Participant's pediatric bone conduction hearing device.~Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.~Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid."
11348792|NCT04147611|FG001|Participant Flow|Normal Hearing Controls|"The normal hearing controls will be limited to 15 adults.~Participants will be tested separately on the six following conditions:~Unaided~Unilateral hearing aid with contralateral plug.~Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)~Bone Conduction Device (BAHA) only~BAHA + Wireless Audio-Streaming Accessory~BAHA + Digital Adaptive RM System~BAHA: Participant's pediatric bone conduction hearing device.~Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.~Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.~Hearing Aid: Participant's unilateral hearing aid with contralateral plug."
11137618|NCT01800786|OG000|Outcome|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
11137619|NCT01800786|OG001|Outcome|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
10887379|NCT00500266|EG000|Reported Event|13vPnC: Visit 1 to Visit 2|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.
11137620|NCT01800786|EG000|Reported Event|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
11137621|NCT01800786|EG001|Reported Event|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
11137622|NCT01800838|BG000|Baseline|Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2)|"Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11149717|NCT01872715|OG000|Outcome|0 = Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
11348793|NCT04147611|OG000|Outcome|Remote Microphone (RM) Technology Group|"The RM technology group will limited to the pediatrics participants.~Participants will be tested separately on the three following conditions:~Bone Conduction Device (BAHA) only~BAHA + Wireless Audio-Streaming Accessory~BAHA + Digital Adaptive RM System~BAHA: Participant's pediatric bone conduction hearing device.~Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.~Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid."
11348794|NCT04147611|OG001|Outcome|Normal Hearing Controls|"The normal hearing controls will be limited to 15 adults.~Participants will be tested separately on the six following conditions:~Unaided~Unilateral hearing aid with contralateral plug.~Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)~Bone Conduction Device (BAHA) only~BAHA + Wireless Audio-Streaming Accessory~BAHA + Digital Adaptive RM System~BAHA: Participant's pediatric bone conduction hearing device.~Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.~Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.~Hearing Aid: Participant's unilateral hearing aid with contralateral plug."
11137623|NCT01800838|BG001|Baseline|Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2)|"Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 100J/cm2 PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137624|NCT01800838|BG002|Baseline|Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2)|"Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 150J/cm2 PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137625|NCT01800838|BG003|Baseline|Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2)|"Patients receive 0.5mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137626|NCT01800838|BG004|Baseline|Total|Total of all reporting groups
11137627|NCT01800838|FG000|Participant Flow|Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50J/cm2)|"Level 1: Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137628|NCT01800838|FG001|Participant Flow|Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100J/cm2)|"Level 2: Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 100J/cm2 PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137629|NCT01800838|FG002|Participant Flow|Pc4 0.1(mg/ml) and Fluence 150(J/cm2)|"Level 3: Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 150J/cm2 PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137630|NCT01800838|FG003|Participant Flow|Pc4 0.5(mg/ml) and Fluence 50(J/cm2)|"Level 4: Patients receive 0.5mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137631|NCT01800838|OG000|Outcome|Treatment (Silicon Phthalocyanine 4 and PDT)|"Patients receive silicon phthalocyanine 4 topically and then undergo PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137632|NCT01800838|EG000|Reported Event|Treatment (Silicon Phthalocyanine 4 and PDT)|"Patients receive silicon phthalocyanine 4 topically and then undergo PDT.~silicon phthalocyanine 4: Given topically~photodynamic therapy: Undergo PDT~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11137633|NCT01800877|BG000|Baseline|Liberal Approach|"In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.~Vasopressors"
11137634|NCT01800877|BG001|Baseline|Restrictive Approach|"We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.~Vasopressors"
11137635|NCT01800877|BG002|Baseline|Total|Total of all reporting groups
11137636|NCT01800877|FG000|Participant Flow|Liberal Approach|"In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.~Vasopressors"
11137637|NCT01800877|FG001|Participant Flow|Restrictive Approach|"We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.~Vasopressors"
11137638|NCT01800877|OG000|Outcome|Liberal Approach|"In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.~Vasopressors"
11137639|NCT01800877|OG001|Outcome|Restrictive Approach|"We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.~Vasopressors"
11137640|NCT01800877|EG000|Reported Event|Liberal Approach|"In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.~Vasopressors"
11137641|NCT01800877|EG001|Reported Event|Restrictive Approach|"We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.~Vasopressors"
11137642|NCT01800890|BG000|Baseline|Overall Study Population|baseline data is given for subjects in the ITT population
11137643|NCT01800890|FG000|Participant Flow|Test A/ Test B/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product B and finally the comparator SenSura
11137644|NCT01800890|FG001|Participant Flow|Test A/ Test C/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product C and finally the comparator SenSura
11137645|NCT01800890|FG002|Participant Flow|Test B/ SenSura/ Test A|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product A
11137646|NCT01800890|FG003|Participant Flow|Test B/ SenSura/ Test C|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product C
11137647|NCT01800890|FG004|Participant Flow|Test C/ Test B/ SenSura|The subjects first tested Coloplast test product C then Cololpast test product B and finally the comparator SenSura
11137648|NCT01800890|FG005|Participant Flow|Test C/ SenSura/ Test A|The subjects first tested Coloplast test product C then the comparator SenSura and finally Cololpast test product A
11137649|NCT01800890|FG006|Participant Flow|SenSura/Test A/Test B|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product B
11137650|NCT01800890|FG007|Participant Flow|SenSura/Test A/Test C|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product C
11137651|NCT01800890|FG008|Participant Flow|SenSura/Test C/Test B|The subjects first tested the comparator product SenSura then Coloplast test product C and finally Cololpast test product B
11137652|NCT01800890|OG000|Outcome|Coloplast Test Product A|new test product
11137653|NCT01800890|OG001|Outcome|Coloplast Test Product B|new test product
11137654|NCT01800890|OG002|Outcome|Coloplast Test Product C|new test product
11137655|NCT01800890|OG003|Outcome|SenSura|The comparator
11137656|NCT01800890|EG000|Reported Event|Coloplast Test Product A|Coloplast Test product A is a new test product
11137657|NCT01800890|EG001|Reported Event|Coloplast Test Product B|Coloplast Test product B is a new test product
10887380|NCT00500266|EG001|Reported Event|13vPnC: 6-month Follow-up|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.
11137658|NCT01800890|EG002|Reported Event|Coloplast Test Product C|Coloplast Test product C is a new test product
11137659|NCT01800890|EG003|Reported Event|SenSura|The comparator was the CE-marked product SenSura Click
11137660|NCT01800903|BG000|Baseline|All Participants|The intention to treat population consists of 36 healthy male subjects
11137661|NCT01800903|FG000|Participant Flow|SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter|First SpeediCath catheter then ZN-D catheter then ZN-C catheter
11137662|NCT01800903|FG001|Participant Flow|SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter|First SpeediCath catheter then ZN-C catheter then ZN-D catheter
11137663|NCT01800903|FG002|Participant Flow|ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter|First ZN-D catheter then SpeediCath catheter then ZN-C catheter
11137664|NCT01800903|FG003|Participant Flow|ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter|First ZN-D catheter then ZN-C catheter then SpeediCath catheter
11137665|NCT01800903|FG004|Participant Flow|ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter|First ZN-C catheter then SpeediCath catheter then ZN-D catheter
11137666|NCT01800903|FG005|Participant Flow|ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter|First ZN-C catheter then ZN-D catheter then SpeediCath catheter
11137667|NCT01800903|OG000|Outcome|ZN-D Catheter|Subjects who tested the ZN-D catheter
11137668|NCT01800903|OG001|Outcome|ZN-C Catheter|Subjects who tested the ZN-C catheter
11137669|NCT01800903|OG002|Outcome|SpeediCath|Subjects who tested the Speedicath catheter
11137670|NCT01800903|EG000|Reported Event|All Participants|"Data from subjects in the safety population. Definition of safety population: subjects that have given informed consent and have been exposed to at least one product.~However for 4 of these subjects no endpoint data was obtained and they were not included in the ITT population; they therefore do not appear in the participant flow module."
11137671|NCT01800916|BG000|Baseline|Overall Study Population|
11137672|NCT01800916|FG000|Participant Flow|Test A/Test B/SenSura|The subjects first tested Coloplast test product A then Coloplast test product B and finally the comparator SenSura
11137673|NCT01800916|FG001|Participant Flow|Test A/Test C/SenSura|The subjects first tested Coloplast test product A then Coloplast test product C and finally the comparator SenSura
11137674|NCT01800916|FG002|Participant Flow|Test B/SenSura/Test A|The subjects first tested Coloplast test product B then SenSura and finally Coloplast test product A
11137675|NCT01800916|FG003|Participant Flow|Test B/SenSura/Test C|The subjects first tested Coloplast test product A then SenSura and finally Coloplast test product B
11137676|NCT01800916|FG004|Participant Flow|Test C/Test B/SenSura|The subjects first tested Coloplast test product C then Coloplast test product A and finally the comparator SenSura
11137677|NCT01800916|FG005|Participant Flow|Test C/SenSura/Test A|The subjects first tested Coloplast test product C then SenSura and finally Coloplast test product A
11137678|NCT01800916|FG006|Participant Flow|SenSura/Test A/Test B|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product B
11137679|NCT01800916|FG007|Participant Flow|SenSura/Test A/Test C|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product C
11137680|NCT01800916|FG008|Participant Flow|SenSura/Test C/Test B|The subjects first tested SenSura then Coloplast test product C and finally Coloplast test product B
11137681|NCT01800916|OG000|Outcome|Test A|
11137682|NCT01800916|OG001|Outcome|Test B|
11137683|NCT01800916|OG002|Outcome|Test C|
11137684|NCT01800916|OG003|Outcome|SenSura|
11137685|NCT01800916|EG000|Reported Event|Test A|
11137686|NCT01800916|EG001|Reported Event|Test B|
11137687|NCT01800916|EG002|Reported Event|Test C|
11137688|NCT01800916|EG003|Reported Event|SenSura|
11137689|NCT01800968|BG000|Baseline|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
11137690|NCT01800968|BG001|Baseline|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
11137691|NCT01800968|BG002|Baseline|Total|Total of all reporting groups
11137692|NCT01800968|FG000|Participant Flow|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
11137693|NCT01800968|FG001|Participant Flow|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
11137694|NCT01800968|OG000|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
10879683|NCT00459316|FG001|Participant Flow|Group 2: CD4%<15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening <15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
11137695|NCT01800968|OG001|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
11137696|NCT01800968|EG000|Reported Event|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily.~Liraglutide: Active Drug"
11137697|NCT01800968|EG001|Reported Event|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily.~Placebo: Placebo"
11137698|NCT01801007|BG000|Baseline|Flow Re-Direction Endoluminal Device|The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
11137699|NCT01801007|FG000|Participant Flow|Flow Re-Direction Endoluminal Device|The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
11137700|NCT01801007|OG000|Outcome|Flow Re-Direction Endoluminal Device|The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
11137701|NCT01801007|EG000|Reported Event|Flow Re-Direction Endoluminal Device|The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
11137702|NCT01801111|BG000|Baseline|Alectinib|Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
11137703|NCT01801111|FG000|Participant Flow|Alectinib|Participants received alectinib at a dose of 600 milligrams (mg) via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until disease progression (PD), death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
11137704|NCT01801111|OG000|Outcome|Alectinib|Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
11137705|NCT01801111|EG000|Reported Event|Alectinib|Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
11137706|NCT01801124|BG000|Baseline|EXPAREL|undiluted EXPAREL 266 mg
11137707|NCT01801124|FG000|Participant Flow|EXPAREL|All subjects received a total of 266mg EXPAREL (bupicavaine liposome injectable suspension) diluted with preservative-free 0.9% normal saline to a volume of 30mL. Study drug was to be administered with ultrasound guidance by injection through a needle or catheter into the tissue plane between the transversus abdominis and internal oblique muscles of the abdominal wall.
11137708|NCT01801124|OG000|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
11137709|NCT01801124|EG000|Reported Event|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
11137710|NCT01801241|BG000|Baseline|Anatomic TSA Using SOC Instrumentation|"During Anatomic Total Shoulder Arthroplasty, the surgeon will use the pre operative CT scan at least two weeks prior to surgery to define the glenoid pathology, select the implant of choice and plan the placement of that implant in the desired position. This information will be available to the surgeon at the time of surgery but the SmartBone models and the IRI will not be available. The surgeon will have pre operative x-rays and the pre operative CT scan provided by the radiology department for intra - use. The surgeon will perform the surgery using any of the instruments provided for guide pin placement operative the. These include a wide variety of free hand and adjustable guides that assist the surgeon for placement of the guide pin for location and trajectory.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant."
11137711|NCT01801241|BG001|Baseline|Anatomic TSA Using IRI Instrumentation|"During Anatomic Total Shoulder Arthroplasty, the surgeon will have use of the SmartBone model of the patient's anatomy and glenoid guide-pin location, and the Intelligent Reuseable Instrument for placement of the glenoid implant.~Anatomic TSA using IRI Instrumentation: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Intelligent Reusable Instrument (IRI) to transfer the pre-operative plan for glenoid implant positioning to the patient's anatomy.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant."
11137712|NCT01801241|BG002|Baseline|Total|Total of all reporting groups
11149718|NCT01872715|OG001|Outcome|1 = Near Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
11009136|NCT01100086|BG000|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
11009137|NCT01100086|FG000|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 10-mg tablet (test) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
11009138|NCT01100086|FG001|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
11009139|NCT01100086|OG000|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
11009140|NCT01100086|OG001|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
11009141|NCT01100086|EG000|Reported Event|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
11009142|NCT01100086|EG001|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
11009143|NCT01100112|BG000|Baseline|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
11009144|NCT01100112|FG000|Participant Flow|Budesonide|"Budesonide-multi-matrix system (MMX) 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
11009145|NCT01100112|OG000|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
11009146|NCT01100112|EG000|Reported Event|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
11009147|NCT01100242|BG000|Baseline|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
11009148|NCT01100242|FG000|Participant Flow|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
11009149|NCT01100242|OG000|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
11009150|NCT01100242|EG000|Reported Event|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
11009151|NCT01100255|BG000|Baseline|Group A|0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
11009152|NCT01100255|BG001|Baseline|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
11009153|NCT01100255|BG002|Baseline|Total|Total of all reporting groups
11009154|NCT01100255|FG000|Participant Flow|Group A|0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
11009155|NCT01100255|FG001|Participant Flow|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
11009156|NCT01100255|OG000|Outcome|Saline Infusion|"IV saline infusion over 40 minutes~Saline: saline infusion"
11009157|NCT01100255|OG001|Outcome|Ketamine Infusion|"0.5mg/kg IV infusion over 40 minutes~Ketamine infusion: 0.5mg/kg IV over 40 minutes"
11009158|NCT01100255|EG000|Reported Event|Saline Infusion|IV saline infusion over 40 minutes
11009159|NCT01100255|EG001|Reported Event|Ketamine Infusion|0.5mg/kg IV ketamine infusion over 40 minutes
11009160|NCT01100268|BG000|Baseline|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
10887381|NCT00500292|BG000|Baseline|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
11149719|NCT01872715|OG002|Outcome|2 = Mild|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
10887382|NCT00500292|BG001|Baseline|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
11009161|NCT01100268|FG000|Participant Flow|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
11009162|NCT01100268|OG000|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
11009163|NCT01100268|EG000|Reported Event|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
11009164|NCT01100307|BG000|Baseline|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
11009165|NCT01100307|BG001|Baseline|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
11009166|NCT01100307|BG002|Baseline|Total|Total of all reporting groups
11009167|NCT01100307|FG000|Participant Flow|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
11137713|NCT01801241|FG000|Participant Flow|Anatomic TSA Using SOC Instrumentation|"During Anatomic Total Shoulder Arthroplasty, the surgeon will use the pre operative CT scan at least two weeks prior to surgery to define the glenoid pathology, select the implant of choice and plan the placement of that implant in the desired position. This information will be available to the surgeon at the time of surgery but the SmartBone models and the IRI will not be available. The surgeon will have pre operative x-rays and the pre operative CT scan provided by the radiology department for intra - use. The surgeon will perform the surgery using any of the instruments provided for guide pin placement operative the. These include a wide variety of free hand and adjustable guides that assist the surgeon for placement of the guide pin for location and trajectory.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant."
11137714|NCT01801241|FG001|Participant Flow|Anatomic TSA Using IRI Instrumentation|"During Anatomic Total Shoulder Arthroplasty, the surgeon will have use of the SmartBone model of the patient's anatomy and glenoid guide-pin location, and the Intelligent Reuseable Instrument for placement of the glenoid implant.~Anatomic TSA using IRI Instrumentation: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Intelligent Reusable Instrument (IRI) to transfer the pre-operative plan for glenoid implant positioning to the patient's anatomy.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant."
11137715|NCT01801241|OG000|Outcome|Anatomic TSA Using SOC Instrumentation|"During Anatomic Total Shoulder Arthroplasty, the surgeon will use the pre operative CT scan at least two weeks prior to surgery to define the glenoid pathology, select the implant of choice and plan the placement of that implant in the desired position. This information will be available to the surgeon at the time of surgery but the SmartBone models and the IRI will not be available. The surgeon will have pre operative x-rays and the pre operative CT scan provided by the radiology department for intra - use. The surgeon will perform the surgery using any of the instruments provided for guide pin placement operative the. These include a wide variety of free hand and adjustable guides that assist the surgeon for placement of the guide pin for location and trajectory.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant."
11137716|NCT01801241|OG001|Outcome|Anatomic TSA Using IRI Instrumentation|"During Anatomic Total Shoulder Arthroplasty, the surgeon will have use of the SmartBone model of the patient's anatomy and glenoid guide-pin location, and the Intelligent Reuseable Instrument for placement of the glenoid implant.~Anatomic TSA using IRI Instrumentation: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Intelligent Reusable Instrument (IRI) to transfer the pre-operative plan for glenoid implant positioning to the patient's anatomy.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant."
11137717|NCT01801241|EG000|Reported Event|Anatomic TSA Using SOC Instrumentation|"During Anatomic Total Shoulder Arthroplasty, the surgeon will use the pre operative CT scan at least two weeks prior to surgery to define the glenoid pathology, select the implant of choice and plan the placement of that implant in the desired position. This information will be available to the surgeon at the time of surgery but the SmartBone models and the IRI will not be available. The surgeon will have pre operative x-rays and the pre operative CT scan provided by the radiology department for intra - use. The surgeon will perform the surgery using any of the instruments provided for guide pin placement operative the. These include a wide variety of free hand and adjustable guides that assist the surgeon for placement of the guide pin for location and trajectory.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant."
11137718|NCT01801241|EG001|Reported Event|Anatomic TSA Using IRI Instrumentation|"During Anatomic Total Shoulder Arthroplasty, the surgeon will have use of the SmartBone model of the patient's anatomy and glenoid guide-pin location, and the Intelligent Reuseable Instrument for placement of the glenoid implant.~Anatomic TSA using IRI Instrumentation: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Intelligent Reusable Instrument (IRI) to transfer the pre-operative plan for glenoid implant positioning to the patient's anatomy.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant."
11137719|NCT01801280|BG000|Baseline|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
11149720|NCT01872715|OG003|Outcome|3 = Moderate|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
10887383|NCT00500292|BG002|Baseline|Placebo Plus FOLFOX|placebo plus FOLFOX
10887384|NCT00500292|BG003|Baseline|Total|Total of all reporting groups
10887385|NCT00500292|FG000|Participant Flow|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
10887386|NCT00500292|FG001|Participant Flow|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
10887387|NCT00500292|FG002|Participant Flow|Placebo Plus FOLFOX|placebo plus FOLFOX
11137720|NCT01801280|BG001|Baseline|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
11137721|NCT01801280|BG002|Baseline|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
11137722|NCT01801280|BG003|Baseline|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
11137723|NCT01801280|BG004|Baseline|Total|Total of all reporting groups
11137724|NCT01801280|FG000|Participant Flow|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
11137725|NCT01801280|FG001|Participant Flow|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
11137726|NCT01801280|FG002|Participant Flow|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
11137727|NCT01801280|FG003|Participant Flow|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
11137728|NCT01801280|OG000|Outcome|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
11137729|NCT01801280|OG001|Outcome|MMF+PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
11137730|NCT01801280|OG002|Outcome|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
11137731|NCT01801280|OG003|Outcome|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
11137732|NCT01801280|EG000|Reported Event|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
11137733|NCT01801280|EG001|Reported Event|MMF + PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
11137734|NCT01801280|EG002|Reported Event|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
11137735|NCT01801280|EG003|Reported Event|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
10887388|NCT00500292|OG000|Outcome|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
11137736|NCT01801358|BG000|Baseline|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137737|NCT01801358|BG001|Baseline|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137738|NCT01801358|BG002|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137739|NCT01801358|BG003|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137740|NCT01801358|BG004|Baseline|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
10887389|NCT00500292|OG001|Outcome|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
11137741|NCT01801358|BG005|Baseline|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137742|NCT01801358|BG006|Baseline|Total|Total of all reporting groups
11137743|NCT01801358|FG000|Participant Flow|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137744|NCT01801358|FG001|Participant Flow|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137745|NCT01801358|FG002|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137746|NCT01801358|FG003|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137747|NCT01801358|FG004|Participant Flow|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137748|NCT01801358|FG005|Participant Flow|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137749|NCT01801358|OG000|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137750|NCT01801358|OG001|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137751|NCT01801358|OG002|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137752|NCT01801358|OG003|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137753|NCT01801358|OG004|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137754|NCT01801358|OG005|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137755|NCT01801358|OG000|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
11137756|NCT01801358|OG000|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137757|NCT01801358|OG001|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137758|NCT01801358|OG002|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
10887390|NCT00500292|OG002|Outcome|Placebo Plus FOLFOX|placebo plus FOLFOX
10887391|NCT00500292|EG000|Reported Event|Vandetanib 100 mg|vandetanib 100 mg plus FOLFOX
11137759|NCT01801358|OG003|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137760|NCT01801358|OG004|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137761|NCT01801358|OG005|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137762|NCT01801358|OG006|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
11137763|NCT01801358|OG000|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137764|NCT01801358|OG001|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137765|NCT01801358|OG002|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137766|NCT01801358|OG003|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137767|NCT01801358|OG004|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137768|NCT01801358|OG005|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11149721|NCT01872715|OG004|Outcome|4 = Severe|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
10887392|NCT00500292|EG001|Reported Event|Vandetanib 300 mg|vandetanib 300 mg plus FOLFOX
11009168|NCT01100307|FG001|Participant Flow|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
11009169|NCT01100307|OG000|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
11009170|NCT01100307|OG001|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
11009171|NCT01100307|EG000|Reported Event|Pegaptanib Sodium (Baseline to Week 24)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24).
11009172|NCT01100307|EG001|Reported Event|Sham (Baseline to Week 24)|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication.
11009173|NCT01100307|EG002|Reported Event|Pegaptanib Sodium (Baseline to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
11009174|NCT01100307|EG003|Reported Event|Sham Conversion (Week 24 to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
11009175|NCT01100320|BG000|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
11009176|NCT01100320|FG000|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
11009177|NCT01100320|FG001|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
11009178|NCT01100320|OG000|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009179|NCT01100320|OG001|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009180|NCT01100320|EG000|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009181|NCT01100320|EG001|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009182|NCT01100437|BG000|Baseline|Entire Study Population|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participant's pain up to 35 days. The participants then started the Maintenance Phase and were administered the established stable dose of EMBEDA for a minimum of 7 days up to 28 days. Eligible participants were randomized into the 2 treatment groups.
11009183|NCT01100437|FG000|Participant Flow|EMBEDA Capsule Then EMBEDA Solution|EMBEDA (morphine sulfate plus naltrexone hydrochloride) Extended Release (ER) capsule(s) were administered orally once or twice a day (20 milligrams [mg] to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participant was administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered whole EMBEDA capsules orally at participant's stable dose along with a matched placebo solution in the first intervention period. In the second intervention period the participant received crushed EMBEDA capsules that were mixed in solution and administered orally at participant's stable dose along with matched placebo capsules.
11009184|NCT01100437|FG001|Participant Flow|EMBEDA Solution Then EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participants were administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered crushed EMBEDA capsules orally at participants stable dose mixed in solution along with matched placebo capsules in the first intervention period. In the second intervention period the participant received whole EMBEDA capsules administered orally at participant's stable dose along with matched placebo solution.
11137769|NCT01801358|OG000|Outcome|Phase Ib (Dose Escalation)|"For Phase Ib, a minimum of three patients will be entered into each cohort and evaluated for safety (DLTs and any other medically significant event) at the end of Cycle 1.~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
10887393|NCT00500292|EG002|Reported Event|Placebo|placebo plus FOLFOX
11137770|NCT01801358|OG000|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137771|NCT01801358|OG001|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137772|NCT01801358|OG002|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137773|NCT01801358|OG003|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137774|NCT01801358|OG004|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137775|NCT01801358|OG005|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137776|NCT01801358|EG000|Reported Event|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137777|NCT01801358|EG001|Reported Event|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137778|NCT01801358|EG002|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137779|NCT01801358|EG003|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137780|NCT01801358|EG004|Reported Event|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137781|NCT01801358|EG005|Reported Event|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
11137782|NCT01801436|BG000|Baseline|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
11137783|NCT01801436|FG000|Participant Flow|Bortezomib|Participants received 1.3 milligram per meter square (mg per m^2) of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
11137784|NCT01801436|OG000|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
11137785|NCT01801436|EG000|Reported Event|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
11137786|NCT01801449|BG000|Baseline|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
11137787|NCT01801449|FG000|Participant Flow|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week.Total duration of the study 24 months.
10887394|NCT00500318|BG000|Baseline|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
11137788|NCT01801449|OG000|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
11137789|NCT01801449|OG000|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week.Total duration of the study 24 months.
11137790|NCT01801449|EG000|Reported Event|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
11137791|NCT01801475|BG000|Baseline|Pregnant Women|"Full term pregnant women scheduled for Cesarean section and will be given Ondansetron as standard-of-care prior to surgery.~Ondansetron: Pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
11137792|NCT01801475|BG001|Baseline|Non-pregnant Women|"Non-pregnant women scheduled for surgery at Stanford who will be given Ondansetron prior to their surgery as standard-of-care.~Ondansetron: non-pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
11137793|NCT01801475|BG002|Baseline|Neonates|"Babies of the pregnant women enrolled in the study; no ondansetron is given to babies in this Aim 1 of the study. Babies of pregnant women are not given Ondansetron but are in the study for 24-48 hours."
11137794|NCT01801475|BG003|Baseline|Total|Total of all reporting groups
11137795|NCT01801475|FG000|Participant Flow|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
11137796|NCT01801475|FG001|Participant Flow|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
11137797|NCT01801475|FG002|Participant Flow|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
11137798|NCT01801475|FG003|Participant Flow|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
11137799|NCT01801475|FG004|Participant Flow|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
11137800|NCT01801475|OG000|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
11137801|NCT01801475|OG001|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
11137802|NCT01801475|EG000|Reported Event|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
11137803|NCT01801475|EG001|Reported Event|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
11137804|NCT01801475|EG002|Reported Event|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
11137805|NCT01801475|EG003|Reported Event|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
11137806|NCT01801475|EG004|Reported Event|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
11137807|NCT01801735|BG000|Baseline|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
11137808|NCT01801735|FG000|Participant Flow|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
11137809|NCT01801735|OG000|Outcome|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
11137810|NCT01801735|EG000|Reported Event|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
11137811|NCT01801865|BG000|Baseline|MRI for Neonates|"MRI~GE OPTIMA MR430s with HDX/GE Electronics: MRI scan"
11137812|NCT01801865|FG000|Participant Flow|MRI for Neonates|"MRI~GE OPTIMA MR430s with HDX/GE Electronics: MRI scan"
11137813|NCT01801865|OG000|Outcome|MRI for Neonates|"MRI~GE OPTIMA MR430s with HDX/GE Electronics: MRI scan"
11137814|NCT01801865|EG000|Reported Event|MRI for Neonates|MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan
11137815|NCT01801917|BG000|Baseline|BAF312 2mg/BAF312 2mg|Patients in Period 1 continue on same 2 mg dose of BAF312 in Period 2
11137816|NCT01801917|BG001|Baseline|BAF312 10 mg/BAF312 10 mg|Patients in Period 1 continue on same 10 mg dose of BAF312 in Period 2
11137817|NCT01801917|BG002|Baseline|Placebo/BAF312 2 mg|Patients on placebo in Period 1 switch to active 2 mg BAF312 in Period 2
11137818|NCT01801917|BG003|Baseline|Placebo/BAF312 10 mg|Patients on placebo in Period 1 switch to active 10 mg BAF312 in Period 2
11137819|NCT01801917|BG004|Baseline|Total|Total of all reporting groups
11137820|NCT01801917|FG000|Participant Flow|BAF312 2mg/BAF312 2mg|Patients in Period 1 continue on same 2 mg dose of BAF312 in Period 2
11137821|NCT01801917|FG001|Participant Flow|BAF312 10 mg/BAF312 10 mg|Patients in Period 1 continue on same 10 mg dose of BAF312 in Period 2
11137822|NCT01801917|FG002|Participant Flow|Placebo/BAF312 2 mg|Patients on placebo in Period 1 switch to active 2 mg BAF312 in Period 2
11137823|NCT01801917|FG003|Participant Flow|Placebo/BAF312 10 mg|Patients on placebo in Period 1 switch to active 10 mg BAF312 in Period 2
11009185|NCT01100437|FG002|Participant Flow|EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administrated and titrated to a dose that adequately managed the participants pain for up to 35 days. In the Maintenance Phase the participant's were administered the established stable dose for a minimum of 7 days up to 28 days. Participants were not randomized to treatment phase.
11137824|NCT01801917|OG000|Outcome|BAF312 2mg|1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during Period 1
11137825|NCT01801917|OG001|Outcome|BAF312 10 mg|5 tablets of BAF312 2 mg daily during Period 1
11137826|NCT01801917|OG002|Outcome|Placebo|matching placebo
11137827|NCT01801917|OG001|Outcome|Placebo/BAF312 2 mg|Patients on placebo in Period 1 switch to active 2 mg BAF312 in Period 2
11137828|NCT01801917|EG000|Reported Event|Period 1 BAF312 2mg|Period 1 BAF312 2mg
10887395|NCT00500318|BG001|Baseline|Placebo|Dose-matched placebo, oral inhalation, once per day.
10887396|NCT00500318|BG002|Baseline|Total|Total of all reporting groups
11137829|NCT01801917|EG001|Reported Event|Period 1 BAF312 10mg|Period 1 BAF312 10mg
11137830|NCT01801917|EG002|Reported Event|Period 1 Placebo|Period 1 Placebo
11137831|NCT01801917|EG003|Reported Event|Period 2 BAF312 2mg/ BAF312 2mg|Period 2 BAF312 2mg/ BAF312 2mg
11137832|NCT01801917|EG004|Reported Event|Period 2 Placebo/ BAF312 2mg|Period 2 Placebo/ BAF312 2mg
11137833|NCT01801930|BG000|Baseline|Dose Level 1|"OCV-103 and OCV-104 (0.3 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137834|NCT01801930|BG001|Baseline|Dose Level 2|"OCV-103 and OCV-104 (1 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137835|NCT01801930|BG002|Baseline|Dose Level 3|"OCV-103 and OCV-104 (3 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137836|NCT01801930|BG003|Baseline|Dose Level 4|"OCV-103 and OCV-104 (6 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137837|NCT01801930|BG004|Baseline|Total|Total of all reporting groups
11137838|NCT01801930|FG000|Participant Flow|Dose Level 1|"OCV-103 and OCV-104 (0.3 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137839|NCT01801930|FG001|Participant Flow|Dose Level 2|"OCV-103 and OCV-104 (1 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137840|NCT01801930|FG002|Participant Flow|Dose Level 3|"OCV-103 and OCV-104 (3 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137841|NCT01801930|FG003|Participant Flow|Dose Level 4|"OCV-103 and OCV-104 (6 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137842|NCT01801930|OG000|Outcome|Dose Level 1|"OCV-103 and OCV-104 (0.3 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137843|NCT01801930|OG001|Outcome|Dose Level 2|"OCV-103 and OCV-104 (1 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137844|NCT01801930|OG002|Outcome|Dose Level 3|"OCV-103 and OCV-104 (3 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137845|NCT01801930|OG003|Outcome|Dose Level 4|"OCV-103 and OCV-104 (6 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137846|NCT01801930|EG000|Reported Event|Dose Level 1|"OCV-103 and OCV-104 (0.3 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11009186|NCT01100437|OG000|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
11009187|NCT01100437|OG001|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
11009188|NCT01100437|OG000|Outcome|EMBEDA Capsules|EMBEDA whole capsules, administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
11009189|NCT01100437|EG000|Reported Event|EMBEDA Whole Capsule Treatment Period|EMBEDA whole capsules, administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
11009190|NCT01100437|EG001|Reported Event|EMBEDA Crushed in Solution Treatment Period|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo whole capsules in any treatment period .
11009191|NCT01100437|EG002|Reported Event|EMBEDA Capsule Titration/Stabilization Period|EMBEDA capsule(s) administered orally once or twice a day (20 mg go 120 mg) to adequately manage the participants pain.
11009192|NCT01100437|EG003|Reported Event|EMBEDA Capsules Maintenance Period|EMBEDA capsule(s) administered orally once or twice a day dose (20 mg go 120 mg) at the participants stable dose for 7 days minimum.
11009193|NCT01100502|BG000|Baseline|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
11009194|NCT01100502|BG001|Baseline|Placebo|placebo every 3 weeks by IV infusion
11009195|NCT01100502|BG002|Baseline|Total|Total of all reporting groups
11009196|NCT01100502|FG000|Participant Flow|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
11009197|NCT01100502|FG001|Participant Flow|Placebo|placebo every 3 weeks by IV infusion
11009198|NCT01100502|OG000|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
11009199|NCT01100502|OG001|Outcome|Placebo|placebo every 3 weeks by IV infusion
11009200|NCT01100502|EG000|Reported Event|Placebo|placebo every 3 weeks by IV infusion
11009201|NCT01100502|EG001|Reported Event|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
11009202|NCT01100528|BG000|Baseline|Arm I: Dacarbazine + Recombinant Interferon Alfa-2b|"Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the second dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3 times a week for 24 weeks in the absence of disease progression or unacceptable toxicity.~recombinant interferon alfa-2b: Given SC 3 times a week for 24 weeks~dacarbazine: Given IV on days 1 and 29~laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up"
11009203|NCT01100528|FG000|Participant Flow|Arm I: Dacarbazine + Recombinant Interferon Alfa-2b|"Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the second dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3 times a week for 24 weeks in the absence of disease progression or unacceptable toxicity.~recombinant interferon alfa-2b: Given subcutaneously (SC) 3 times a week for 24 weeks~dacarbazine: Given IV on days 1 and 29~laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up"
11009204|NCT01100528|OG000|Outcome|Arm I: Dacarbazine + Recombinant Interferon Alfa-2b|"Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the second dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3 times a week for 24 weeks in the absence of disease progression or unacceptable toxicity.~recombinant interferon alfa-2b: Given SC 3 times a week for 24 weeks~dacarbazine: Given IV on days 1 and 29~laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up"
11009205|NCT01100528|EG000|Reported Event|Arm I: Dacarbazine + Recombinant Interferon Alfa-2b|"Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the second dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3 times a week for 24 weeks in the absence of disease progression or unacceptable toxicity.~recombinant interferon alfa-2b: Given SC 3 times a week for 24 weeks~dacarbazine: Given IV on days 1 and 29~laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up"
11009206|NCT01100567|BG000|Baseline|LMMS|Randomized to 10 min LMMS daily
11009207|NCT01100567|BG001|Baseline|Placebo|Randomized to sham platform 10 min daily
11009208|NCT01100567|BG002|Baseline|Total|Total of all reporting groups
11009209|NCT01100567|FG000|Participant Flow|LMMS|Randomized to 10 min LMMS daily
11009210|NCT01100567|FG001|Participant Flow|Placebo|Randomized to sham platform 10 min daily
11009211|NCT01100567|OG000|Outcome|LMMS|Randomized to 10 min LMMS daily
11009212|NCT01100567|OG001|Outcome|Placebo|Randomized to sham platform 10 min daily
11009213|NCT01100567|EG000|Reported Event|LMMS|Randomized to 10 min LMMS daily
11009214|NCT01100567|EG001|Reported Event|Placebo|Randomized to sham platform 10 min daily
11009215|NCT01100606|BG000|Baseline|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
11009216|NCT01100606|FG000|Participant Flow|EUR-1008 (APT-1008) in Apple Juice First, Then in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kilogram body weight/day (lipase units/kg/day).
11137847|NCT01801930|EG001|Reported Event|Dose Level 2|"OCV-103 and OCV-104 (1 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137848|NCT01801930|EG002|Reported Event|Dose Level 3|"OCV-103 and OCV-104 (3 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137849|NCT01801930|EG003|Reported Event|Dose Level 4|"OCV-103 and OCV-104 (6 mg of each)~One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle."
11137850|NCT01801982|BG000|Baseline|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
11137851|NCT01801982|FG000|Participant Flow|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
11137852|NCT01801982|OG000|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
11137853|NCT01801982|EG000|Reported Event|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
11137854|NCT01802073|BG000|Baseline|Oral Vancomycin-Children|"For children who weight < or = 30 kg, the vancomycin dose will be 50 mg/kg/day given orally 3 times per day for the 1st month and continue with the same dose for subsequent months if the clinical laboratory studies improved and are normal. If the laboratory studies are not normal the dose will be increased to 75 mg/kg/day given orally 3 times per day for the 2nd month and 100mg/kg/day given orally 3 times per day the 3rd month. If the laboratory studies do not improve by the end of the 3rd month since starting the vancomycin, the vancomycin will be stopped and the child will not continue the study.~Oral Vancomycin"
11137855|NCT01802073|BG001|Baseline|Oral Vancomycin-Adults|"For adults and children who weigh >30 kg, the vancomycin dose will be 500 mg given orally 3 times per day for the 1st month and continue with this dose if the clinical laboratory studies improve and are normal. If the laboratory studies are not normal the dose will be increased to 750 mg 3 times per day for the 2nd month and 1000 mg 3 times per day the 3rd month.~Oral Vancomycin"
11137856|NCT01802073|BG002|Baseline|Total|Total of all reporting groups
11137857|NCT01802073|FG000|Participant Flow|Oral Vancomycin-Children|"For children who weight < or = 30 kg, the vancomycin dose will be 50 mg/kg/day given orally 3 times per day for the 1st month and continue with the same dose for subsequent months if the clinical laboratory studies improved and are normal. If the laboratory studies are not normal the dose will be increased to 75 mg/kg/day given orally 3 times per day for the 2nd month and 100mg/kg/day given orally 3 times per day the 3rd month. If the laboratory studies do not improve by the end of the 3rd month since starting the vancomycin, the vancomycin will be stopped and the child will not continue the study.~Oral Vancomycin"
11137858|NCT01802073|FG001|Participant Flow|Oral Vancomycin-Adults|"For adults and children who weigh >30 kg, the vancomycin dose will be 500 mg given orally 3 times per day for the 1st month and continue with this dose if the clinical laboratory studies improve and are normal. If the laboratory studies are not normal the dose will be increased to 750 mg 3 times per day for the 2nd month and 1000 mg 3 times per day the 3rd month.~Oral Vancomycin"
11137859|NCT01802073|OG000|Outcome|Oral Vancomycin-Children|"For children who weight < or = 30 kg, the vancomycin dose will be 50 mg/kg/day given orally 3 times per day for the 1st month and continue with the same dose for subsequent months if the clinical laboratory studies improved and are normal. If the laboratory studies are not normal the dose will be increased to 75 mg/kg/day given orally 3 times per day for the 2nd month and 100mg/kg/day given orally 3 times per day the 3rd month. If the laboratory studies do not improve by the end of the 3rd month since starting the vancomycin, the vancomycin will be stopped and the child will not continue the study.~Oral Vancomycin"
11137860|NCT01802073|OG001|Outcome|Oral Vancomycin-Adults|"For adults and children who weigh >30 kg, the vancomycin dose will be 500 mg given orally 3 times per day for the 1st month and continue with this dose if the clinical laboratory studies improve and are normal. If the laboratory studies are not normal the dose will be increased to 750 mg 3 times per day for the 2nd month and 1000 mg 3 times per day the 3rd month.~Oral Vancomycin"
11137861|NCT01802073|EG000|Reported Event|Oral Vancomycin-Children|"For children who weight < or = 30 kg, the vancomycin dose will be 50 mg/kg/day given orally 3 times per day for the 1st month and continue with the same dose for subsequent months if the clinical laboratory studies improved and are normal. If the laboratory studies are not normal the dose will be increased to 75 mg/kg/day given orally 3 times per day for the 2nd month and 100mg/kg/day given orally 3 times per day the 3rd month. If the laboratory studies do not improve by the end of the 3rd month since starting the vancomycin, the vancomycin will be stopped and the child will not continue the study.~Oral Vancomycin"
11137862|NCT01802073|EG001|Reported Event|Oral Vancomycin-Adults|"For adults and children who weigh >30 kg, the vancomycin dose will be 500 mg given orally 3 times per day for the 1st month and continue with this dose if the clinical laboratory studies improve and are normal. If the laboratory studies are not normal the dose will be increased to 750 mg 3 times per day for the 2nd month and 1000 mg 3 times per day the 3rd month.~Oral Vancomycin"
11137863|NCT01802151|BG000|Baseline|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
11137864|NCT01802151|BG001|Baseline|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137865|NCT01802151|BG002|Baseline|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137866|NCT01802151|BG003|Baseline|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137867|NCT01802151|BG004|Baseline|Total|Total of all reporting groups
11137868|NCT01802151|FG000|Participant Flow|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
10887397|NCT00500318|FG000|Participant Flow|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
10887398|NCT00500318|FG001|Participant Flow|Placebo|Dose-matched placebo, oral inhalation, once per day.
11137869|NCT01802151|FG001|Participant Flow|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137870|NCT01802151|FG002|Participant Flow|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137871|NCT01802151|FG003|Participant Flow|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137872|NCT01802151|OG000|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
11137873|NCT01802151|OG001|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137874|NCT01802151|OG002|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137875|NCT01802151|OG003|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
10887399|NCT00500318|OG000|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
11137876|NCT01802151|EG000|Reported Event|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
11137877|NCT01802151|EG001|Reported Event|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137878|NCT01802151|EG002|Reported Event|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137879|NCT01802151|EG003|Reported Event|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
11137880|NCT01802216|BG000|Baseline|Control/Delayed Treatment|Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Rescue scaling and root planing only to sites of periodontal disease progression (since prior examination) of greater than 3mm. Subjects will be informed of their assignment to the delayed treatment group and provided referral list of local dentists should patient not feel comfortable waiting until end of study for full intensive periodontal disease treatment. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.
11137881|NCT01802216|BG001|Baseline|Intensive Periodontal Disease Treatment|"Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Intensive periodontal disease treatment to include administration of local anesthetic to up to two quadrants for scaling and root planing with ultrasonic and hand instruments. Minocycline will be applied to any sites with probing depth >=5mm. Hopeless teeth in scaled quadrants will be extracted. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.~Scaling and root planing: non-surgical periodontal disease treatment~Minocycline: antibiotic microspheres"
11137882|NCT01802216|BG002|Baseline|Total|Total of all reporting groups
11137883|NCT01802216|FG000|Participant Flow|Control/Delayed Treatment|Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Rescue scaling and root planing only to sites of periodontal disease progression (since prior examination) of greater than 3mm. Subjects will be informed of their assignment to the delayed treatment group and provided referral list of local dentists should patient not feel comfortable waiting until end of study for full intensive periodontal disease treatment. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.
11137884|NCT01802216|FG001|Participant Flow|Intensive Periodontal Disease Treatment|"Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Intensive periodontal disease treatment to include administration of local anesthetic to up to two quadrants for scaling and root planing with ultrasonic and hand instruments. Minocycline will be applied to any sites with probing depth >=5mm. Hopeless teeth in scaled quadrants will be extracted. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.~Scaling and root planing: non-surgical periodontal disease treatment~Minocycline: antibiotic microspheres"
11137885|NCT01802216|OG000|Outcome|Control/Delayed Treatment|Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Rescue scaling and root planing only to sites of periodontal disease progression (since prior examination) of greater than 3mm. Subjects will be informed of their assignment to the delayed treatment group and provided referral list of local dentists should patient not feel comfortable waiting until end of study for full intensive periodontal disease treatment. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.
11137886|NCT01802216|OG001|Outcome|Intensive Periodontal Disease Treatment|"Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Intensive periodontal disease treatment to include administration of local anesthetic to up to two quadrants for scaling and root planing with ultrasonic and hand instruments. Minocycline will be applied to any sites with probing depth >=5mm. Hopeless teeth in scaled quadrants will be extracted. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.~Scaling and root planing: non-surgical periodontal disease treatment~Minocycline: antibiotic microspheres"
11137887|NCT01802216|EG000|Reported Event|Control/Delayed Treatment|Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Rescue scaling and root planing only to sites of periodontal disease progression (since prior examination) of greater than 3mm. Subjects will be informed of their assignment to the delayed treatment group and provided referral list of local dentists should patient not feel comfortable waiting until end of study for full intensive periodontal disease treatment. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.
10887400|NCT00500318|OG001|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
10887401|NCT00500318|EG000|Reported Event|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
11137888|NCT01802216|EG001|Reported Event|Intensive Periodontal Disease Treatment|"Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Intensive periodontal disease treatment to include administration of local anesthetic to up to two quadrants for scaling and root planing with ultrasonic and hand instruments. Minocycline will be applied to any sites with probing depth >=5mm. Hopeless teeth in scaled quadrants will be extracted. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.~Scaling and root planing: non-surgical periodontal disease treatment~Minocycline: antibiotic microspheres"
11137889|NCT01802320|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
11137890|NCT01802320|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
11137891|NCT01802320|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
11137892|NCT01802320|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
11137893|NCT01802333|BG000|Baseline|Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)|"INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Daunorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11137894|NCT01802333|BG001|Baseline|Arm II (High-dose Cytarabine, Idarubicin)|"INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Idarubicin: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11137895|NCT01802333|BG002|Baseline|Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)|"INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Idarubicin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11137896|NCT01802333|BG003|Baseline|Total|Total of all reporting groups
11137897|NCT01802333|FG000|Participant Flow|Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)|"INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Daunorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11137898|NCT01802333|FG001|Participant Flow|Arm II (High-dose Cytarabine, Idarubicin)|"INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Idarubicin: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10887402|NCT00500318|EG001|Reported Event|Placebo|Dose-matched placebo, oral inhalation, once per day.
11137899|NCT01802333|FG002|Participant Flow|Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)|"INDUCTION/RE-INDUCTION: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Idarubicin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11149722|NCT01872715|OG000|Outcome|Very Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
10887403|NCT00500331|BG000|Baseline|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
11137900|NCT01802333|OG000|Outcome|Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)|"INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Daunorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11137901|NCT01802333|OG001|Outcome|Arm II (High-dose Cytarabine, Idarubicin)|"INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Idarubicin: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11137902|NCT01802333|OG002|Outcome|Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)|"INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.~CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5.~TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant~Cytarabine: Given IV~Idarubicin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11137903|NCT01802333|OG000|Outcome|High Risk Patients in First Complete Remission|This group includes patients from any of the three treatment arms who have high-risk AML (by cytogenetics) and who achieved a complete remission (CR) or complete remission with incomplete blood count recovery (CRi).
11137904|NCT01802333|OG000|Outcome|High Risk Patients|This group includes patients from any of the three treatment arms who have high-risk AML (by cytogenetics).
11137905|NCT01802333|OG000|Outcome|Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)|INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
11137906|NCT01802333|OG001|Outcome|Arm II (High-dose Cytarabine, Idarubicin)|INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
11137907|NCT01802333|OG002|Outcome|Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)|INDUCTION/RE-INDUCTION: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
11137908|NCT01802333|OG000|Outcome|All Arms Combined|This group includes all patients enrolled to the trial, regardless of treatment assignment.
11137909|NCT01802333|EG000|Reported Event|Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)|INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
11137910|NCT01802333|EG001|Reported Event|Arm II (High-dose Cytarabine, Idarubicin)|INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
11137911|NCT01802333|EG002|Reported Event|Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)|INDUCTION/RE-INDUCTION: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy.
11137912|NCT01802385|BG000|Baseline|Placebo|"Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day).~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks."
11137913|NCT01802385|BG001|Baseline|Sertraline 400mg|"Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day plus adjunctive sertraline therapy at 400mg/day for 2 weeks, then 200mg for 12 weeks, and then tapered over 3 weeks.~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks."
11137914|NCT01802385|BG002|Baseline|Total|Total of all reporting groups
11137915|NCT01802385|FG000|Participant Flow|Placebo|"Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day).~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks."
11137916|NCT01802385|FG001|Participant Flow|Sertraline 400mg|"Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day plus adjunctive sertraline therapy at 400mg/day for 2 weeks, then 200mg for 12 weeks, and then tapered over 3 weeks.~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks."
11137917|NCT01802385|OG000|Outcome|Placebo|"Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day).~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks."
11137918|NCT01802385|OG001|Outcome|Sertraline 400mg|"Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day plus adjunctive sertraline therapy at 400mg/day for 2 weeks, then 200mg for 12 weeks, and then tapered over 3 weeks.~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks."
11137919|NCT01802385|EG000|Reported Event|Placebo|"Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day).~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks."
11137920|NCT01802385|EG001|Reported Event|Sertraline 400mg|"Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day plus adjunctive sertraline therapy at 400mg/day for 2 weeks, then 200mg for 12 weeks, and then tapered over 3 weeks.~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks."
11137921|NCT01802411|BG000|Baseline|EXPAREL 266 mg|"Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg [6.6 mL] to each of three nerve segments)~EXPAREL 266 mg"
11137922|NCT01802411|BG001|Baseline|Placebo|"Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments)~Placebo"
11137923|NCT01802411|BG002|Baseline|Total|Total of all reporting groups
11137924|NCT01802411|FG000|Participant Flow|EXPAREL 266 mg|"Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg [6.6 mL] to each of three nerve segments)~EXPAREL 266 mg"
11137925|NCT01802411|FG001|Participant Flow|Placebo|"Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments)~Placebo"
11137926|NCT01802411|OG000|Outcome|EXPAREL 266 mg|"Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg [6.6 mL] to each of three nerve segments)~EXPAREL 266 mg"
11137927|NCT01802411|OG001|Outcome|Placebo|"Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments)~Placebo"
11137928|NCT01802411|EG000|Reported Event|EXPAREL 266 mg|"Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg [6.6 mL] to each of three nerve segments)~EXPAREL 266 mg"
11137929|NCT01802411|EG001|Reported Event|Placebo|"Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments)~Placebo"
11137930|NCT01802437|BG000|Baseline|Talk Therapy 4-Week Decision Point|Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
11137931|NCT01802437|BG001|Baseline|Talk Therapy 8-Week Decision Point|"Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.~Interpersonal Psychotherapy: Adolescent randomized to an increase in therapy (4 extra therapy sessions)"
11137932|NCT01802437|BG002|Baseline|Total|Total of all reporting groups
11137933|NCT01802437|FG000|Participant Flow|Talk Therapy 4-Week Decision Point|Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
11137934|NCT01802437|FG001|Participant Flow|Talk Therapy 8-Week Decision Point|Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
11137935|NCT01802437|OG000|Outcome|Talk Therapy 4-Week Decision Point|Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
10887404|NCT00500331|BG001|Baseline|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11137936|NCT01802437|OG001|Outcome|Talk Therapy 8-Week Decision Point|"Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.~Interpersonal Psychotherapy: Adolescent randomized to an increase in therapy (4 extra therapy sessions)"
11137937|NCT01802437|EG000|Reported Event|Talk Therapy 4-Week Decision Point|Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
11137938|NCT01802437|EG001|Reported Event|Talk Therapy 8-Week Decision Point|"Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.~Interpersonal Psychotherapy: Adolescent randomized to an increase in therapy (4 extra therapy sessions)"
11137939|NCT01802515|BG000|Baseline|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
11137940|NCT01802515|BG001|Baseline|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
11137941|NCT01802515|BG002|Baseline|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
11137942|NCT01802515|BG003|Baseline|Total|Total of all reporting groups
11137943|NCT01802515|FG000|Participant Flow|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
11137944|NCT01802515|FG001|Participant Flow|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
11137945|NCT01802515|FG002|Participant Flow|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
11137946|NCT01802515|OG000|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
11137947|NCT01802515|OG001|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
11137948|NCT01802515|OG002|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
11137949|NCT01802515|EG000|Reported Event|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
11137950|NCT01802515|EG001|Reported Event|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
11137951|NCT01802515|EG002|Reported Event|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
11149723|NCT01872715|OG001|Outcome|Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
11137952|NCT01802554|BG000|Baseline|Pleasant Events Program (PEP)|The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
11137953|NCT01802554|BG001|Baseline|Information Support (IS)|Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.
11137954|NCT01802554|BG002|Baseline|Total|Total of all reporting groups
11137955|NCT01802554|FG000|Participant Flow|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS) : Supportive Psychotherapy and informational brochures"
11137956|NCT01802554|FG001|Participant Flow|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP) : Behavioral Activation Therapy"
11137957|NCT01802554|OG000|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
11137958|NCT01802554|OG001|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
11137959|NCT01802554|EG000|Reported Event|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
11137960|NCT01802554|EG001|Reported Event|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
11137961|NCT01802580|BG000|Baseline|Intervention - Internet Reminder Survey|"Treatment phase is 12 months. During the intervention, each subject will receive fluocinonide 0.05% ointment, a standard treatment for psoriasis. If their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. They will be asked to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed. They will receive weekly surveys via internet to complete.~Internet Survey~fluocinonide 0.05% ointment"
11149724|NCT01872715|OG002|Outcome|Neither Satisfied Nor Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
11149725|NCT01872715|OG003|Outcome|Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
11137962|NCT01802580|BG001|Baseline|Standard of Care, no Internet Survey|"Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.~fluocinonide 0.05% ointment"
11137963|NCT01802580|BG002|Baseline|Total|Total of all reporting groups
11137964|NCT01802580|FG000|Participant Flow|Intervention - Internet Reminder Survey|"Treatment phase is 12 months. During the intervention, each subject will receive fluocinonide 0.05% ointment, a standard treatment for psoriasis. If their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. They will be asked to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed. They will receive weekly surveys via internet to complete.~Internet Survey~fluocinonide 0.05% ointment"
11137965|NCT01802580|FG001|Participant Flow|Standard of Care, no Internet Survey|"Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.~fluocinonide 0.05% ointment"
11137966|NCT01802580|OG000|Outcome|Intervention - Internet Reminder Survey|"Treatment phase is 12 months. During the intervention, each subject will receive fluocinonide 0.05% ointment, a standard treatment for psoriasis. If their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. They will be asked to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed. They will receive weekly surveys via internet to complete.~Internet Survey~fluocinonide 0.05% ointment"
11137967|NCT01802580|OG001|Outcome|Standard of Care, no Internet Survey|"Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.~fluocinonide 0.05% ointment"
11137968|NCT01802580|EG000|Reported Event|Intervention - Internet Reminder Survey|"Treatment phase is 12 months. During the intervention, each subject will receive fluocinonide 0.05% ointment, a standard treatment for psoriasis. If their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. They will be asked to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed. They will receive weekly surveys via internet to complete.~Internet Survey~fluocinonide 0.05% ointment"
11137969|NCT01802580|EG001|Reported Event|Standard of Care, no Internet Survey|"Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.~fluocinonide 0.05% ointment"
11137970|NCT01802710|BG000|Baseline|Psychological Support|"Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson~Psychological support + conventional medical treatment"
11137971|NCT01802710|BG001|Baseline|No Psychological Support|"Patients of this group only received the conventional medical treatment, not receiving any psychological support~No psychological intervention"
11137972|NCT01802710|BG002|Baseline|Total|Total of all reporting groups
11137973|NCT01802710|FG000|Participant Flow|Psychological Support|"Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson~Psychological support + conventional medical treatment"
11137974|NCT01802710|FG001|Participant Flow|No Psychological Support|"Patients of this group only received the conventional medical treatment, not receiving any psychological support~Only conventional medical treatment"
11137975|NCT01802710|OG000|Outcome|Psychological Support|"Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson~Psychological support + conventional medical treatment"
11137976|NCT01802710|OG001|Outcome|No Psychological Support|"Patients of this group only received the conventional medical treatment, not receiving any psychological support~No psychological intervention"
11137977|NCT01802710|OG000|Outcome|Psychological Support|"Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) proressive-muscle relaxation according to Jacobson~Psychological support + conventional medical treatment"
11137978|NCT01802710|OG001|Outcome|No Psychological Support|"Patients of this group only received the conventional medical treatment, not receiving any psychological support~Only conventional medical treatment"
11137979|NCT01802710|EG000|Reported Event|Psychological Support|"Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson~Psychological support"
11137980|NCT01802710|EG001|Reported Event|No Psychological Support|"Patients of this group only received the conventional medical treatment, not receiving any psychological support~No intervention"
11137981|NCT01802775|BG000|Baseline|Clopidogrel|Open-label clopidogrel with aspirin
11137982|NCT01802775|BG001|Baseline|Edoxaban|Open-label edoxaban with aspirin
11137983|NCT01802775|BG002|Baseline|Total|Total of all reporting groups
11137984|NCT01802775|FG000|Participant Flow|Clopidogrel|Open-label clopidogrel with aspirin
11137985|NCT01802775|FG001|Participant Flow|Edoxaban|Open-label edoxaban with aspirin
11137986|NCT01802775|OG000|Outcome|Clopidogrel|Open-label clopidogrel with aspirin
11137987|NCT01802775|OG001|Outcome|Edoxaban|Open-label edoxaban with aspirin
11137988|NCT01802775|EG000|Reported Event|Clopidogrel|Open-label clopidogrel with aspirin
11137989|NCT01802775|EG001|Reported Event|Edoxaban|Open-label edoxaban with aspirin
11137990|NCT01802879|BG000|Baseline|Panobinostat - 10 to 40 mg/Day TIW QoW|10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design
11137991|NCT01802879|FG000|Participant Flow|Panobinostat - 10 to 40 mg/Day TIW QoW|10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design
11137992|NCT01802879|OG000|Outcome|Panobinostat - 10 to 40 mg/Day TIW QoW|10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design
11137993|NCT01802879|EG000|Reported Event|Panobinostat - 10 to 40 mg/Day TIW QoW|10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design
11137994|NCT01803074|BG000|Baseline|Part A-Group 1: BMS-955176 (5 mg)|Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11137995|NCT01803074|BG001|Baseline|Part A-Group 2: BMS-955176 (10 mg)|Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11137996|NCT01803074|BG002|Baseline|Part A-Group 3: BMS-955176 (20 mg)|Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11137997|NCT01803074|BG003|Baseline|Part A-Group 4: BMS-955176 (40 mg)|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11137998|NCT01803074|BG004|Baseline|Part A-Group 9: BMS-955176 (80 mg)|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
11137999|NCT01803074|BG005|Baseline|Part A-Group 10: BMS-955176 (120 mg)|Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
11138000|NCT01803074|BG006|Baseline|Placebo Clade B|Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138001|NCT01803074|BG007|Baseline|Part B-Group 5: BMS-955176 (40 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138002|NCT01803074|BG008|Baseline|Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138003|NCT01803074|BG009|Baseline|Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine|Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138004|NCT01803074|BG010|Baseline|Part B-Group 12: BMS-955176 (80 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138005|NCT01803074|BG011|Baseline|Part C-Group 8: BMS-955176 (40 mg)|Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138006|NCT01803074|BG012|Baseline|Part C-Group 13: BMS-955176 (120 mg)|Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138007|NCT01803074|BG013|Baseline|Placebo Clade C|Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138008|NCT01803074|BG014|Baseline|Total|Total of all reporting groups
11138009|NCT01803074|FG000|Participant Flow|Part A-Group 1: BMS-955176 (5 mg)|Participants infected with Human Immunodeficiency Virus Type-1 (HIV-1) clade B were treated with 5 milligrams (mg) BMS-955176 as oral suspension, once daily (QD) from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138010|NCT01803074|FG001|Participant Flow|Part A-Group 2: BMS-955176 (10 mg)|Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138011|NCT01803074|FG002|Participant Flow|Part A-Group 3: BMS-955176 (20 mg)|Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138012|NCT01803074|FG003|Participant Flow|Part A-Group 4: BMS-955176 (40 mg)|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138013|NCT01803074|FG004|Participant Flow|Part A-Group 9: BMS-955176 (80 mg)|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
11138014|NCT01803074|FG005|Participant Flow|Part A-Group 10: BMS-955176 (120 mg)|Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
11138015|NCT01803074|FG006|Participant Flow|Placebo Clade B|Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138016|NCT01803074|FG007|Participant Flow|Part B-Group 5: BMS-955176 (40 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138017|NCT01803074|FG008|Participant Flow|Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138018|NCT01803074|FG009|Participant Flow|Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine|Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138019|NCT01803074|FG010|Participant Flow|Part B-Group 12: BMS-955176 (80 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138020|NCT01803074|FG011|Participant Flow|Part C-Group 8: BMS-955176 (40 mg)|Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138021|NCT01803074|FG012|Participant Flow|Part C-Group 13: BMS-955176 (120 mg)|Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138022|NCT01803074|FG013|Participant Flow|Placebo Clade C|Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138023|NCT01803074|OG000|Outcome|Part A-Group 1: BMS-955176 (5 mg)|Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138024|NCT01803074|OG001|Outcome|Part A-Group 2: BMS-955176 (10 mg)|Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138025|NCT01803074|OG002|Outcome|Part A-Group 3: BMS-955176 (20 mg)|Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138026|NCT01803074|OG003|Outcome|Part A-Group 4: BMS-955176 (40 mg)|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138027|NCT01803074|OG004|Outcome|Part A-Group 9: BMS-955176 (80 mg)|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
11138028|NCT01803074|OG005|Outcome|Part A-Group 10: BMS-955176 (120 mg)|Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
11138029|NCT01803074|OG006|Outcome|Part B-Group 5: BMS-955176 (40 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11149726|NCT01872715|OG004|Outcome|Very Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
11009217|NCT01100606|FG001|Participant Flow|EUR-1008 (APT-1008) in Apple Sauce First, Then in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kg/day.
11009218|NCT01100606|OG000|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
11009219|NCT01100606|OG001|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
11009220|NCT01100606|OG000|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
11009221|NCT01100606|OG001|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
11009222|NCT01100606|OG000|Outcome|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
11009223|NCT01100606|EG000|Reported Event|Zenpep®|Zenpep® 5,000 from open capsule, mixed with a small amount of apple sauce, orally daily in the screening period for 10 days.
11009224|NCT01100606|EG001|Reported Event|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
11009225|NCT01100606|EG002|Reported Event|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
11009226|NCT01100723|BG000|Baseline|Post Treatment|Results analyzed at study evaluation time points.
11009227|NCT01100723|FG000|Participant Flow|Post Treatment|Patients had their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet dose was increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
11009228|NCT01100723|OG000|Outcome|Post Treatment|Results analyzed at study evaluation time points.
11009229|NCT01100723|OG000|Outcome|Results Analyzed at Study Evaluation Time Points.|Results analyzed at study evaluation time points of 1 year and 6 months.
11009230|NCT01100723|EG000|Reported Event|Post Treatment|Results analyzed at study evaluation time points.
11009231|NCT01100762|BG000|Baseline|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
11009232|NCT01100762|FG000|Participant Flow|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
11009233|NCT01100762|OG000|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
11009234|NCT01100762|OG001|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
11009235|NCT01100762|OG002|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
11009236|NCT01100762|EG000|Reported Event|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
11149727|NCT01872715|EG000|Reported Event|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
11138030|NCT01803074|OG007|Outcome|Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138031|NCT01803074|OG008|Outcome|Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine|Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138032|NCT01803074|OG009|Outcome|Part B-Group 12: BMS-955176 (80 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138033|NCT01803074|OG010|Outcome|Part C-Group 8: BMS-955176 (40 mg)|Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138034|NCT01803074|OG011|Outcome|Part C-Group 13: BMS-955176 (120 mg)|Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138035|NCT01803074|OG012|Outcome|Placebo Clade B|Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138036|NCT01803074|OG013|Outcome|Placebo Clade C|Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138037|NCT01803074|OG006|Outcome|Part C-Group 8: BMS-955176 (40 mg)|Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138038|NCT01803074|OG007|Outcome|Part C-Group 13: BMS-955176 (120 mg)|Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138039|NCT01803074|OG008|Outcome|Placebo Clade B|Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138040|NCT01803074|OG009|Outcome|Placebo Clade C|Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138041|NCT01803074|OG000|Outcome|Part B-Group 5: BMS-955176 (40 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138042|NCT01803074|OG001|Outcome|Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138043|NCT01803074|OG002|Outcome|Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine|Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138044|NCT01803074|OG003|Outcome|Part B-Group 12: BMS-955176 (80 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138045|NCT01803074|OG002|Outcome|Part B-Group 12: BMS-955176 (80 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138046|NCT01803074|EG000|Reported Event|Part A-Group 1: BMS-955176 (5 mg)|Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138047|NCT01803074|EG001|Reported Event|Part A-Group 2: BMS-955176 (10 mg)|Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138048|NCT01803074|EG002|Reported Event|Part A-Group 3: BMS-955176 (20 mg)|Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138049|NCT01803074|EG003|Reported Event|Part A-Group 4: BMS-955176 (40 mg)|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
10887405|NCT00500331|BG002|Baseline|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
10887406|NCT00500331|BG003|Baseline|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11138050|NCT01803074|EG004|Reported Event|Part A-Group 9: BMS-955176 (80 mg)|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
11138051|NCT01803074|EG005|Reported Event|Part A-Group 10: BMS-955176 (120 mg)|Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
11138052|NCT01803074|EG006|Reported Event|Placebo Clade B|Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138053|NCT01803074|EG007|Reported Event|Part B-Group 5: BMS-955176 (40 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138054|NCT01803074|EG008|Reported Event|Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir|Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138055|NCT01803074|EG009|Reported Event|Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine|Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138056|NCT01803074|EG010|Reported Event|Part B-Group 12: BMS-955176 (80 mg) + Atazanavir|Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
11138057|NCT01803074|EG011|Reported Event|Part C-Group 8: BMS-955176 (40 mg)|Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138058|NCT01803074|EG012|Reported Event|Part C-Group 13: BMS-955176 (120 mg)|Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138059|NCT01803074|EG013|Reported Event|Placebo Clade C|Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
11138060|NCT01803204|BG000|Baseline|Booklet - Preoperative Educational|"This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase~Booklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery."
11138061|NCT01803204|BG001|Baseline|Control|This group don't received booklet, they will be monitored during the postoperative period to control
11138062|NCT01803204|BG002|Baseline|Total|Total of all reporting groups
11138063|NCT01803204|FG000|Participant Flow|Booklet - Preoperative Educational|"This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase~Booklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery."
11138064|NCT01803204|FG001|Participant Flow|Control|This group don't received booklet, they will be monitored during the postoperative period to control
10887407|NCT00500331|BG004|Baseline|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11138065|NCT01803204|OG000|Outcome|Booklet - Preoperative Educational|"This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase~Booklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery."
11138066|NCT01803204|OG001|Outcome|Control|This group don't received booklet, they will be monitored during the postoperative period to control
11138067|NCT01803204|EG000|Reported Event|Booklet - Preoperative Educational|"This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase~Booklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery."
11138068|NCT01803204|EG001|Reported Event|Control|This group don't received booklet, they will be monitored during the postoperative period to control
11138069|NCT01803269|BG000|Baseline|Arm A (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV"
11138070|NCT01803269|BG001|Baseline|Arm B (CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV"
11138071|NCT01803269|BG002|Baseline|Cohort C|Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
11138072|NCT01803269|BG003|Baseline|Total|Total of all reporting groups
11138073|NCT01803269|FG000|Participant Flow|Arm A (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV"
11138074|NCT01803269|FG001|Participant Flow|Arm B (CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV"
11138075|NCT01803269|FG002|Participant Flow|Cohort C|Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
11138076|NCT01803269|OG000|Outcome|Arm A (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV"
11138077|NCT01803269|OG001|Outcome|Arm B (CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV"
11138078|NCT01803269|OG002|Outcome|Cohort C|Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
11138079|NCT01803269|EG000|Reported Event|Arm A (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV"
11138080|NCT01803269|EG001|Reported Event|Arm B (CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV"
11138081|NCT01803269|EG002|Reported Event|Cohort C|Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
11138082|NCT01803282|BG000|Baseline|Part A: ADX 200 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138083|NCT01803282|BG001|Baseline|Part A: ADX 600 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138084|NCT01803282|BG002|Baseline|Part A: ADX 1800 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138085|NCT01803282|BG003|Baseline|Part B: PAC, ADX 800 mg|Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138086|NCT01803282|BG004|Baseline|Part B: LAC, ADX 1200 mg|Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138087|NCT01803282|BG005|Baseline|Part B: LSC, ADX 1200 mg|Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138088|NCT01803282|BG006|Baseline|Part B: EGC, ADX 800 mg|Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138089|NCT01803282|BG007|Baseline|Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg|Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138090|NCT01803282|BG008|Baseline|Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg|Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138091|NCT01803282|BG009|Baseline|Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg|Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138092|NCT01803282|BG010|Baseline|Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg|Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138093|NCT01803282|BG011|Baseline|Part B: BRCA, ADX 800 mg|Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138094|NCT01803282|BG012|Baseline|Total|Total of all reporting groups
11138095|NCT01803282|FG000|Participant Flow|Part A: ADX 200 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg andecaliximab (ADX) as monotherapy via intravenous (IV) infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138096|NCT01803282|FG001|Participant Flow|Part A: ADX 600 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138097|NCT01803282|FG002|Participant Flow|Part A: ADX 1800 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
10887408|NCT00500331|BG005|Baseline|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
10887409|NCT00500331|BG006|Baseline|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
11138098|NCT01803282|FG003|Participant Flow|Part B: PAC, ADX 800 mg|Participants with pancreatic adenocarcinoma (PAC) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138099|NCT01803282|FG004|Participant Flow|Part B: LAC, ADX 1200 mg|Participants with lung adenocarcinoma (LAC) received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138100|NCT01803282|FG005|Participant Flow|Part B: LSC, ADX 1200 mg|Participants with lung squamous cell carcinoma (LSC) received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138101|NCT01803282|FG006|Participant Flow|Part B: EGC, ADX 800 mg|Participants with esophagogastric adenocarcinoma (EGC) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+oxaliplatin+5-fluorouracil {5-FU} [mFOLFOX6], on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138102|NCT01803282|FG007|Participant Flow|Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg|Participants with colorectal cancer (CRC) received first-line (FL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138103|NCT01803282|FG008|Participant Flow|Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg|Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138104|NCT01803282|FG009|Participant Flow|Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg|Participants with CRC received second-line (SL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+irinotecan+5-FU [FOLFIRI] and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138105|NCT01803282|FG010|Participant Flow|Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg|Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138106|NCT01803282|FG011|Participant Flow|Part B: BRCA, ADX 800 mg|Participants with breast cancer (BRCA) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138107|NCT01803282|OG000|Outcome|Part A: ADX 200 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138108|NCT01803282|OG001|Outcome|Part A: ADX 600 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138109|NCT01803282|OG002|Outcome|Part A: ADX 1800 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138110|NCT01803282|OG003|Outcome|Part B: PAC, ADX 800 mg|Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138111|NCT01803282|OG004|Outcome|Part B: LAC, ADX 1200 mg|Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138112|NCT01803282|OG005|Outcome|Part B: LSC, ADX 1200 mg|Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138113|NCT01803282|OG006|Outcome|Part B: EGC, ADX 800 mg|Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138114|NCT01803282|OG007|Outcome|Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg|Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138115|NCT01803282|OG008|Outcome|Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg|Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138116|NCT01803282|OG009|Outcome|Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg|Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138117|NCT01803282|OG010|Outcome|Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg|Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138118|NCT01803282|OG011|Outcome|Part B: BRCA, ADX 800 mg|Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138119|NCT01803282|EG000|Reported Event|Part A: ADX 200 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138120|NCT01803282|EG001|Reported Event|Part A: ADX 600 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138121|NCT01803282|EG002|Reported Event|Part A: ADX 1800 mg|Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138122|NCT01803282|EG003|Reported Event|Part B: PAC, ADX 800 mg|Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138123|NCT01803282|EG004|Reported Event|Part B: LAC, ADX 1200 mg|Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
10879684|NCT00459316|FG002|Participant Flow|Group 3: Age ≥2 to <11, CD4%≥25|"Participants ≥2 to <11 years of age with CD4% at screening ≥ 25%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
10879685|NCT00459316|OG000|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
10879686|NCT00459316|OG001|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
11138124|NCT01803282|EG005|Reported Event|Part B: LSC, ADX 1200 mg|Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138125|NCT01803282|EG006|Reported Event|Part B: EGC, ADX 800 mg|Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138126|NCT01803282|EG007|Reported Event|Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg|Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138127|NCT01803282|EG008|Reported Event|Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg|Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138128|NCT01803282|EG009|Reported Event|Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg|Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138129|NCT01803282|EG010|Reported Event|Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg|Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
10879687|NCT00459316|OG002|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
11138130|NCT01803282|EG011|Reported Event|Part B: BRCA, ADX 800 mg|Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11138131|NCT01803464|BG000|Baseline|Botox Plus Low-magnitude Vibration|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.~Botox plus low-magnitude vibration: Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study."
11138132|NCT01803464|BG001|Baseline|Botox|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.~Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study."
11138133|NCT01803464|BG002|Baseline|Cerebral Palsy Control|Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
11138134|NCT01803464|BG003|Baseline|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls.
11138135|NCT01803464|BG004|Baseline|Total|Total of all reporting groups
11138136|NCT01803464|FG000|Participant Flow|Botox Plus Low-magnitude Vibration|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.~Botox plus low-magnitude vibration: Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study."
11138137|NCT01803464|FG001|Participant Flow|Botox|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.~Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study."
11138138|NCT01803464|FG002|Participant Flow|Cerebral Palsy Control|Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
11138139|NCT01803464|FG003|Participant Flow|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls.
11138140|NCT01803464|OG000|Outcome|Botox Plus Low-magnitude Vibration|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.~Botox plus low-magnitude vibration: Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study."
11138141|NCT01803464|OG001|Outcome|Botox|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.~Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study."
11138142|NCT01803464|OG002|Outcome|Cerebral Palsy Control|Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
11138143|NCT01803464|OG003|Outcome|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls.
11138144|NCT01803464|OG000|Outcome|Botox Plus Low-magnitude Vibration|"Cerebral palsy and Botox plus vibration~Low-magnitude vibration: Children will receive a daily low-magnitude vibration treatment.~Botox: Children who are candidates to receive Botox as part of their standard of care."
11138145|NCT01803464|OG001|Outcome|Botox|"Cerebral palsy and Botox~Botox: Children who are candidates to receive Botox as part of their standard of care."
11138146|NCT01803464|OG002|Outcome|Cerebral Palsy Control|Cerebral palsy without treatment
11138147|NCT01803464|OG003|Outcome|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls
11138148|NCT01803464|EG000|Reported Event|Botox Plus Low-magnitude Vibration|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.~Botox plus low-magnitude vibration: Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study."
11138149|NCT01803464|EG001|Reported Event|Botox|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.~Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study."
11138150|NCT01803464|EG002|Reported Event|Cerebral Palsy Control|Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
11138151|NCT01803464|EG003|Reported Event|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls.
11138152|NCT01803607|BG000|Baseline|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
11138153|NCT01803607|BG001|Baseline|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
10879688|NCT00459316|OG003|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
10879689|NCT00459316|OG003|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
11138154|NCT01803607|BG002|Baseline|Total|Total of all reporting groups
11138155|NCT01803607|FG000|Participant Flow|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
11138156|NCT01803607|FG001|Participant Flow|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
11138157|NCT01803607|OG000|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
11138158|NCT01803607|OG001|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
11138159|NCT01803607|EG000|Reported Event|ODN 50 mg OW|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
11138160|NCT01803607|EG001|Reported Event|Placebo OW|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. One participant who was randomized to odanacatib 50 mg OW received placebo during the entire treatment period and was therefore included in the Placebo OW group for safety analyses.
11138161|NCT01803646|BG000|Baseline|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
11138162|NCT01803646|BG001|Baseline|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
11138163|NCT01803646|BG002|Baseline|Total|Total of all reporting groups
11138164|NCT01803646|FG000|Participant Flow|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
11138165|NCT01803646|FG001|Participant Flow|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
11138166|NCT01803646|OG000|Outcome|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
11138167|NCT01803646|OG001|Outcome|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
11138168|NCT01803646|EG000|Reported Event|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
11138169|NCT01803646|EG001|Reported Event|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
11138170|NCT01803737|BG000|Baseline|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
11138171|NCT01803737|BG001|Baseline|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
11138172|NCT01803737|BG002|Baseline|Total|Total of all reporting groups
11138173|NCT01803737|FG000|Participant Flow|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
11138174|NCT01803737|FG001|Participant Flow|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
11138175|NCT01803737|OG000|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
11138176|NCT01803737|OG001|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
11138177|NCT01803737|EG000|Reported Event|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
11138178|NCT01803737|EG001|Reported Event|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
10879690|NCT00459316|OG000|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
11138179|NCT01803880|BG000|Baseline|Part I|Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
11138180|NCT01803880|BG001|Baseline|Part II: RF-based Debridement|Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
11138181|NCT01803880|BG002|Baseline|Part II: Mechanical Debridement|Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
11138182|NCT01803880|BG003|Baseline|Total|Total of all reporting groups
11138183|NCT01803880|FG000|Participant Flow|Part I|Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
11138184|NCT01803880|FG001|Participant Flow|Part II: RF-based Debridement|Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
11138185|NCT01803880|FG002|Participant Flow|Part II: Mechanical Debridement|Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
11138186|NCT01803880|OG000|Outcome|Part II: RF-based Debridement|Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
11138187|NCT01803880|OG001|Outcome|Part II: Mechanical Debridement|Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
10849041|NCT00293384|BG000|Baseline|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
11138188|NCT01803880|OG000|Outcome|Part I|Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
11138189|NCT01803880|OG001|Outcome|Part II: RF-based Debridement|Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
11138190|NCT01803880|OG002|Outcome|Part II: Mechanical Debridement|Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
11138191|NCT01803880|EG000|Reported Event|Part I|Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
11138192|NCT01803880|EG001|Reported Event|Part II: RF-based Debridement|Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
11138193|NCT01803880|EG002|Reported Event|Part II: Mechanical Debridement|Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
11138194|NCT01804036|BG000|Baseline|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
11138195|NCT01804036|BG001|Baseline|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
11138196|NCT01804036|BG002|Baseline|Total|Total of all reporting groups
11138197|NCT01804036|FG000|Participant Flow|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
11138198|NCT01804036|FG001|Participant Flow|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
11138199|NCT01804036|OG000|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
11138200|NCT01804036|OG001|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
11138201|NCT01804036|OG000|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
11138202|NCT01804036|EG000|Reported Event|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
11138203|NCT01804036|EG001|Reported Event|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
11138204|NCT01804049|BG000|Baseline|Placebo|"60 participants will be randomized to placebo pills.~placebo: One placebo capsule by mouth once daily for 1 month followed by one placebo capsule by mouth twice daily for the remainder of the study."
11138205|NCT01804049|BG001|Baseline|Metformin|"60 enrolled participants will be randomized to metformin.~metformin: Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study."
11138206|NCT01804049|BG002|Baseline|Total|Total of all reporting groups
11138207|NCT01804049|FG000|Participant Flow|Placebo|"60 participants will be randomized to placebo pills.~placebo: One placebo capsule by mouth once daily for 1 month followed by one placebo capsule by mouth twice daily for the remainder of the study."
11138208|NCT01804049|FG001|Participant Flow|Metformin|"60 enrolled participants will be randomized to metformin.~metformin: Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study."
11138209|NCT01804049|OG000|Outcome|Placebo|"60 participants will be randomized to placebo pills.~placebo: One placebo capsule by mouth once daily for 1 month followed by one placebo capsule by mouth twice daily for the remainder of the study."
11138210|NCT01804049|OG001|Outcome|Metformin|"60 enrolled participants will be randomized to metformin.~metformin: Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study."
11138211|NCT01804049|OG000|Outcome|Placebo|A subgroup of the main study consented to muscle biopsy at time 0 and 6 months of the study. 13 participants were randomized to the placebo biopsy substudy. Placebo was administered as per the main study.
11138212|NCT01804049|OG001|Outcome|Metformin|A subgroup of the main study consented to muscle biopsy at time 0 and 6 months of the study. 19 participants were randomized to the metformin biopsy substudy. Metformin was administered as per the main study.
11138213|NCT01804049|EG000|Reported Event|Placebo|"60 participants were to be randomized to placebo pills.~placebo: One placebo capsule by mouth once daily for 1 month followed by one placebo capsule by mouth twice daily for the remainder of the study.~43 participants were allocated to the placebo group."
11138214|NCT01804049|EG001|Reported Event|Metformin|"60 enrolled participants were to be randomized to metformin.~metformin: Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study.~77 participants were allocated to the metformin group."
11138215|NCT01804062|BG000|Baseline|no Treatment|no treatment, prospective observational
11138216|NCT01804062|FG000|Participant Flow|no Treatment|no treatment, prospective observational
11138217|NCT01804062|OG000|Outcome|no Treatment|no treatment, prospective observational
11138218|NCT01804062|EG000|Reported Event|no Treatment|no treatment, prospective observational
11138219|NCT01804075|BG000|Baseline|Morphine Treated|infants randomized to receive morphine as their primary treatment for withdrawal
11138220|NCT01804075|BG001|Baseline|Methadone Treated|infants randomized to receive methadone as their primary treatment for withdrawal
11138221|NCT01804075|BG002|Baseline|Total|Total of all reporting groups
11138222|NCT01804075|FG000|Participant Flow|Methadone|"Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:~NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose~Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)~Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.~If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.~Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
11138223|NCT01804075|FG001|Participant Flow|Morphine|"Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:~NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose~Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)~Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.~If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.~Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
11138224|NCT01804075|OG000|Outcome|Methadone-treated|group of infants randomized to receive methadone treatment for their withdrawal
11009237|NCT01100853|BG000|Baseline|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
11009238|NCT01100853|BG001|Baseline|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
11009239|NCT01100853|BG002|Baseline|Total|Total of all reporting groups
11009240|NCT01100853|FG000|Participant Flow|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
11009241|NCT01100853|FG001|Participant Flow|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
11009242|NCT01100853|OG000|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
11009243|NCT01100853|OG001|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
11009244|NCT01100853|EG000|Reported Event|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
11009245|NCT01100853|EG001|Reported Event|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
11009246|NCT01100931|BG000|Baseline|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
11009247|NCT01100931|BG001|Baseline|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
11009248|NCT01100931|BG002|Baseline|Total|Total of all reporting groups
11009249|NCT01100931|FG000|Participant Flow|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
11009250|NCT01100931|FG001|Participant Flow|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
11009251|NCT01100931|OG000|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
11009252|NCT01100931|OG000|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
11009253|NCT01100931|OG001|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
11009254|NCT01100931|EG000|Reported Event|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
11009255|NCT01100931|EG001|Reported Event|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
11009256|NCT01100944|BG000|Baseline|All Participants|All participants who had at least one dose of Belinostat.
11009257|NCT01100944|FG000|Participant Flow|Belinostat 250mg/m(2) and Chemotherapy|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009258|NCT01100944|FG001|Participant Flow|Belinostat 500mg/m(2) and Chemotherapy|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009259|NCT01100944|FG002|Participant Flow|Belinostat and Chemotherapy at the Maximum Tolerated Dose(MTD)|Patients were treated with belinostat, doxorubicin, cisplatin and cyclophosphamide at the maximum tolerated dose derived from the phase I dose level.
11138225|NCT01804075|OG001|Outcome|Morphine-treated|Group randomized to receive morphine treatment for their withdrawal
11138226|NCT01804075|OG000|Outcome|Methadone Treated|infants randomized to receive methadone as their primary treatment for withdrawal
10879691|NCT00459316|OG001|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
11138227|NCT01804075|OG001|Outcome|Morphine Treated|infants randomized to receive morphine as their primary treatment for withdrawal
11138228|NCT01804075|EG000|Reported Event|Methadone|"Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:~NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose~Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)~Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.~If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.~Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
11138229|NCT01804075|EG001|Reported Event|Morphine|"Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:~NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose~Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)~Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.~If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.~Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
11138230|NCT01804101|BG000|Baseline|Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138231|NCT01804101|BG001|Baseline|Arm II (Closed to Accrual Effective 4/21/14)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138232|NCT01804101|BG002|Baseline|Total|Total of all reporting groups
11138233|NCT01804101|FG000|Participant Flow|Arm I (Lower-dose CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138234|NCT01804101|FG001|Participant Flow|Arm II (Higher Dose COX-351)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138235|NCT01804101|OG000|Outcome|Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138236|NCT01804101|OG001|Outcome|Arm II (Closed to Accrual Effective 4/21/14)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138237|NCT01804101|OG000|Outcome|Arm I (Lower-dose CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138238|NCT01804101|OG001|Outcome|Arm II (Higher Dose COX-351)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138239|NCT01804101|EG000|Reported Event|Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138240|NCT01804101|EG001|Reported Event|Arm II (Closed to Accrual Effective 4/21/14)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
11138241|NCT01804114|BG000|Baseline|Local Anesthetic Continuous Infusion|"Pain management following hernia repair~Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair"
11138242|NCT01804114|BG001|Baseline|Placebo Continuous Infusion|"Placebo pain management following hernia repair~Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair"
11138243|NCT01804114|BG002|Baseline|Total|Total of all reporting groups
11138244|NCT01804114|FG000|Participant Flow|Local Anesthetic Continuous Infusion|"Pain management following hernia repair~Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair"
11138245|NCT01804114|FG001|Participant Flow|Placebo Continuous Infusion|"Placebo pain management following hernia repair~Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair"
11138246|NCT01804114|OG000|Outcome|Local Anesthetic Continuous Infusion|"Pain management following hernia repair~Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair"
11138247|NCT01804114|OG001|Outcome|Placebo Continuous Infusion|"Placebo pain management following hernia repair~Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair"
11138248|NCT01804114|EG000|Reported Event|Local Anesthetic Continuous Infusion|"Pain management following hernia repair~Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair"
11138249|NCT01804114|EG001|Reported Event|Placebo Continuous Infusion|"Placebo pain management following hernia repair~Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair"
11138250|NCT01804140|BG000|Baseline|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
11138251|NCT01804140|FG000|Participant Flow|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
11138252|NCT01804140|OG000|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
11138253|NCT01804140|EG000|Reported Event|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
11138254|NCT01804257|BG000|Baseline|Digital Health Feedback System (DHFS)|"Ingestion Sensor, Wearable Sensor~Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living"
11138255|NCT01804257|FG000|Participant Flow|Digital Health Feedback System (DHFS)|"Ingestion Sensor, Wearable Sensor~Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living"
11138256|NCT01804257|OG000|Outcome|Digital Health Feedback System (DHFS)|Ingestion Sensor,...
11138257|NCT01804257|EG000|Reported Event|Digital Health Feedback System (DHFS)|DHFS
11138258|NCT01804465|BG000|Baseline|Immediate IpilimumabTreatment|"Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.~SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.~Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion."
11149728|NCT01872819|BG000|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions"
10879692|NCT00459316|OG002|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
10879693|NCT00459316|OG001|Outcome|Group 1B|Participants aged 11 to 24 with a CD4 percentage of or greater than 15%, 2 doses MCV4 vaccine
11138259|NCT01804465|BG001|Baseline|Delayed IpilimumabTreatment|"Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.~SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.~Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion."
11138260|NCT01804465|BG002|Baseline|Total|Total of all reporting groups
11138261|NCT01804465|FG000|Participant Flow|Immediate IpilimumabTreatment|"Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of Sipuleucel-T (SipT).~SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.~Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion."
11138262|NCT01804465|FG001|Participant Flow|Delayed IpilimumabTreatment|"Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.~SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.~Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion."
11138263|NCT01804465|OG000|Outcome|Immediate IpilimumabTreatment|"Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.~SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.~Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion."
11138264|NCT01804465|OG001|Outcome|Delayed IpilimumabTreatment|"Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.~SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.~Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion."
11138265|NCT01804465|EG000|Reported Event|Immediate IpilimumabTreatment|"Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.~SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.~Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion."
11138266|NCT01804465|EG001|Reported Event|Delayed IpilimumabTreatment|"Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.~SipT Treatment: All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.~Ipilimumab: Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion."
11138267|NCT01804582|BG000|Baseline|Family Navigator Consultation|"Family Navigator consultation: Telephone contact from the trained family navigator to the parent participant several times over the 90 day study time period. Components of the service include the following:~(1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, (3) discuss potential benefits/challenges of options and parent preferences/priorities for care; (4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan."
11138268|NCT01804582|BG001|Baseline|Usual Care|No specific study intervention is provided to this group of parents. This control group will received the usual care that they have been receiving from their child's providers.
11138269|NCT01804582|BG002|Baseline|Total|Total of all reporting groups
11138270|NCT01804582|FG000|Participant Flow|Family Navigator Consultation|"Family Navigator consultation: Telephone contact from the trained family navigator to the parent participant several times over the 90 day study time period. Components of the service include the following:~(1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, (3) discuss potential benefits/challenges of options and parent preferences/priorities for care;(4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan."
11138271|NCT01804582|FG001|Participant Flow|Usual Care|No specific study intervention is provided to this group of parents. This control group will received the usual care that they have been receiving from their child's providers.
11149729|NCT01872819|FG000|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions~16 patients were enrolled. 14 patients were treated."
10879694|NCT00459316|OG000|Outcome|Week 4|Group 2 participants at Week 4
10879695|NCT00459316|OG001|Outcome|Week 28|Group 2 participants at Week 28 (4 weeks after second vaccination)
10879696|NCT00459316|OG002|Outcome|Week 72|Group 2 participants at Week 72
11138272|NCT01804582|OG000|Outcome|Family Navigator Consultation|"Family Navigator consultation: Telephone contact from the trained family navigator to the parent participant several times over the 90 day study time period. Components of the service include the following:~(1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, (3) discuss potential benefits/challenges of options and parent preferences/priorities for care;(4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan."
11138273|NCT01804582|OG001|Outcome|Usual Care|No specific study intervention is provided to this group of parents. This control group will received the usual care that they have been receiving from their child's providers.
11138274|NCT01804582|OG000|Outcome|Family Navigator Consultation|"This group of parents will be contacted by a Family Navigator to assist them in accessing psychosocial resources based on their child and family needs. Components of this intervention are the following:~(1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, or mental health resources for other household family members; (3) discuss potential benefits/challenges of options and parent preferences/priorities for care; (4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan.~Family Navigator consultation: Telephone contact from the trained family navigator to the parent participant several times over the 90 day study time period. Components of the service include the following:~(1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs,"
11138275|NCT01804582|EG000|Reported Event|Family Navigator Consultation|Family Navigator consultation: Telephone contact from the trained family navigator to the parent participant several times over the 90 day study time period. Components of the service include the following: (1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, or mental health resources for other household family members; (3) discuss potential benefits/challenges of options and parent preferences/priorities for care; (4) assessment on perceived barriers to seeking resources; (5)collaborative problem solving to address barriers; (6) discuss options for follow up plan.
11138276|NCT01804582|EG001|Reported Event|Usual Care|No specific study intervention is provided to this group of parents. This control group will received the usual care that they have been receiving from their child's providers.
11138277|NCT01804673|BG000|Baseline|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
11138278|NCT01804673|FG000|Participant Flow|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
11138279|NCT01804673|OG000|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
11138280|NCT01804673|EG000|Reported Event|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
10879697|NCT00459316|OG002|Outcome|Group 3: Age 2-<6|Participants 2 to <6 years with CD4%>=25
10879698|NCT00459316|OG003|Outcome|Group 3: Age 6-<11|Participants 6 to <11 years with CD4%>=25
11138281|NCT01804842|BG000|Baseline|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
11138282|NCT01804842|BG001|Baseline|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
11138283|NCT01804842|BG002|Baseline|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
11138284|NCT01804842|BG003|Baseline|Total|Total of all reporting groups
11138285|NCT01804842|FG000|Participant Flow|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
11138286|NCT01804842|FG001|Participant Flow|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
11138287|NCT01804842|FG002|Participant Flow|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
11138288|NCT01804842|OG000|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
11138289|NCT01804842|OG001|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
11138290|NCT01804842|OG002|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
11138291|NCT01804842|EG000|Reported Event|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
10879699|NCT00459316|OG000|Outcome|Group 1|Participants ≤11 to <25 years of age with CD4% at screening ≥15%
10879700|NCT00459316|OG001|Outcome|Group 3|Participants >=2 to <11 years of age with CD4% at screening ≥ 25%
10879701|NCT00459316|OG002|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25, 2 doses MCV4 vaccine
10879702|NCT00459316|EG000|Reported Event|Group 1 (15<CD4%≤25)|Participants ≥11 to <25 years with 15<CD4%≤25
11138292|NCT01804842|EG001|Reported Event|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
11138293|NCT01804842|EG002|Reported Event|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
11138294|NCT01804881|BG000|Baseline|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
11138295|NCT01804881|BG001|Baseline|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
11138296|NCT01804881|BG002|Baseline|Total|Total of all reporting groups
11138297|NCT01804881|FG000|Participant Flow|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
11138298|NCT01804881|FG001|Participant Flow|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
11138299|NCT01804881|OG000|Outcome|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
11138300|NCT01804881|OG001|Outcome|Wait List Control|wait list, offered craving change program at end of study
11138301|NCT01804881|OG000|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
11138302|NCT01804881|OG001|Outcome|Wait List Control|wait list, offered group program at end of study
11138303|NCT01804881|EG000|Reported Event|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
11138304|NCT01804881|EG001|Reported Event|Wait List Control|wait list, offered craving change program at end of study
11138305|NCT01804946|BG000|Baseline|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.~Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
11138306|NCT01804946|BG001|Baseline|Oseltamivir Group (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
11138307|NCT01804946|BG002|Baseline|Total|Total of all reporting groups
11138308|NCT01804946|FG000|Participant Flow|Ergoferon Group (EG)|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
11138309|NCT01804946|FG001|Participant Flow|Oseltamivir Group (OG)|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
11138310|NCT01804946|OG000|Outcome|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.~Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
10879703|NCT00459316|EG001|Reported Event|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
11138311|NCT01804946|OG001|Outcome|Oseltamivir Goup (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
11138312|NCT01804946|OG000|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
11138313|NCT01804946|OG001|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
11138314|NCT01804946|EG000|Reported Event|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
11138315|NCT01804946|EG001|Reported Event|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
11138316|NCT01805024|BG000|Baseline|Cohort 1 0.02 mg/kg/Day|Omigapil treatment, oral administration once per day after breakfast
11138317|NCT01805024|BG001|Baseline|Cohort 2 0.08 mg/kg/Day|Omigapil treatment, oral administration once per day after breakfast
11138318|NCT01805024|BG002|Baseline|Cohort 3a 0.04 mg/kg/Day|Omigapil treatment, oral administration once per day after breakfast
11138319|NCT01805024|BG003|Baseline|Cohort 3b 0.06 mg/kg/Day|Omigapil treatment, oral administration once per day after breakfast
10879704|NCT00459316|EG002|Reported Event|Group 2|Participants ≥11 to <25 years with CD4%<15
10879705|NCT00459316|EG003|Reported Event|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
10887410|NCT00500331|BG007|Baseline|Total|Total of all reporting groups
11138320|NCT01805024|BG004|Baseline|Total|Total of all reporting groups
11138321|NCT01805024|FG000|Participant Flow|Cohort 1 0.02 mg/kg/Day|Omigapil Treatment, oral administration once per day after breakfast
11138322|NCT01805024|FG001|Participant Flow|Cohort 2 0.08 mg/kg/Day|Omigapil Treatment, oral administration once per day after breakfast
11138323|NCT01805024|FG002|Participant Flow|Cohort 3a 0.04 mg/kg/Day|Omigapil Treatment, oral administration once per day after breakfast
11138324|NCT01805024|FG003|Participant Flow|Cohort 3b 0.06 mg/kg/Day|Omigapil Treatment, oral administration once per day after breakfast
11138325|NCT01805024|OG000|Outcome|Cohort 1 0.02 mg/kg/Day|Omigapil Treatment Oral Administration once per day after breakfast
11138326|NCT01805024|OG001|Outcome|Cohort 2 0.08 mg/kg/Day|Omigapil Treatment Oral Administration once per day after breakfast
11138327|NCT01805024|OG002|Outcome|Cohort 3a 0.04 mg/kg/Day|Omigapil Treatment Oral Administration once per day after breakfast
11138328|NCT01805024|OG003|Outcome|Cohort 3b 0.06 mg/kg/Day|Omigapil Treatment Oral Administration once per day after breakfast
11138329|NCT01805024|EG000|Reported Event|Cohort 1 0.02 mg/kg/Day|Omigapil Treatment, oral Administration once per day after breakfast
11138330|NCT01805024|EG001|Reported Event|Cohort 2 0.08 mg/kg/Day|Omigapil Treatment, oral Administration once per day after breakfast
11138331|NCT01805024|EG002|Reported Event|Cohort 3a 0.04 mg/kg/Day|Omigapil Treatment, oral Administration once per day after breakfast
11138332|NCT01805024|EG003|Reported Event|Cohort 3b 0.06 mg/kg/Day|Omigapil Treatment, oral Administration once per day after breakfast
11149730|NCT01872819|OG000|Outcome|Treated Patients|14 patients were treated.
11149731|NCT01872819|OG000|Outcome|Treated Patients|
11149732|NCT01872819|EG000|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions"
11138333|NCT01805037|BG000|Baseline|Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)|"Induction:~Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks~Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks)~Consolidation (optional): Identical to Induction.~Maintenance:~Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease.~Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease."
11138334|NCT01805037|FG000|Participant Flow|Brentuximab Vedotin Dose Level -1 (0.8 mg/kg)|"Treatment:~Induction:~Brentuximab vedotin 0.8 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks )~Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks)~Consolidation (optional): Identical to Induction.~Maintenance: Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease."
11138335|NCT01805037|FG001|Participant Flow|Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)|"Induction:~Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks~Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks)~Consolidation (optional): Identical to Induction.~Maintenance:~Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease.~Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease."
11138336|NCT01805037|OG000|Outcome|Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)|"Induction:~Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks~Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks)~Consolidation (optional): Identical to Induction.~Maintenance:~Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease.~Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease."
11138337|NCT01805037|EG000|Reported Event|Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)|"Induction:~Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks~Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks)~Consolidation (optional): Identical to Induction.~Maintenance:~Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease.~Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease."
11138338|NCT01805089|BG000|Baseline|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
11138339|NCT01805089|BG001|Baseline|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
11138340|NCT01805089|BG002|Baseline|Total|Total of all reporting groups
11138341|NCT01805089|FG000|Participant Flow|Melatonin 3mg|"Taken orally, once per day, at/around 9:00pm~Melatonin"
11138342|NCT01805089|FG001|Participant Flow|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
11138343|NCT01805089|OG000|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
10879706|NCT00459342|BG000|Baseline|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10879707|NCT00459342|FG000|Participant Flow|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11138344|NCT01805089|OG001|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
11138345|NCT01805089|EG000|Reported Event|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
11138346|NCT01805089|EG001|Reported Event|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
11138347|NCT01805154|BG000|Baseline|CRT Patients|"Patients who have received any market approved St Jude Medical CRT-D or CRT-P device~CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from a CRT device."
11138348|NCT01805154|FG000|Participant Flow|Cardiac Resynchronization Therapy Patients|"Patients who have received any market approved St Jude Medical cardiac resynchronization therapy defibrillator (CRT-D) or cardiac resynchronization therapy pacemaker (CRT-P) device.~Cardiac resynchronization therapy patients: This is a group of patients who are receiving bi-ventricular pacing therapy from cardiac resynchronization therapy device."
11138349|NCT01805154|OG000|Outcome|CRT Patients|Patients who received any market approved St. Jude Medical CRT-D or CRT-P device.
11138350|NCT01805154|OG000|Outcome|CRT Patients|Patients who have received any market approved St. Jude Medical CRT-D or CRT-P device
11138351|NCT01805154|OG000|Outcome|Site CRT Responders|"Patients who have received any market approved St Jude Medical CRT-D or CRT-P device~CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device and were classified as CRT responders at 6 months."
11138352|NCT01805154|OG001|Outcome|Site CRT Non-Responders|"Patients who have received any market approved St Jude Medical CRT-D or CRT-P device~CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device and were classified as CRT non-responders at 6 months."
11138353|NCT01805154|EG000|Reported Event|CRT Patients|"Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.~Of 1529 subjects enrolled, 5 were not included in analysis (1 had incomplete informed consent and 4 did not receive a device implant)."
11138354|NCT01805180|BG000|Baseline|Arm 1|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
11138355|NCT01805180|BG001|Baseline|Arm 2|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
11138356|NCT01805180|BG002|Baseline|Total|Total of all reporting groups
11138357|NCT01805180|FG000|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
11138358|NCT01805180|FG001|Participant Flow|Arm 1 - Spectra Optia Followed by COBE Spectra PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the Spectra Optia first, followed by the COBE Spectra.
11138359|NCT01805180|FG002|Participant Flow|Arm 2 - COBE Spectra Followed by Spectra Optia PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the COBE Spectra first, followed by the Spectra Optia.
11138360|NCT01805180|OG000|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
11138361|NCT01805180|OG001|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
11138362|NCT01805180|OG000|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
11138363|NCT01805180|OG000|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. Device deficiency was not reported by randomization treatment arms.
11138364|NCT01805180|EG000|Reported Event|Spectra Optia|A total of n=48 subjects were either randomized to receive a procedure (n=42) or were assigned the Spectra Optia as a lead-in subject (lead-in n=6). Lead-in donors were not randomized and received the Spectra Optia only for training purposes and are included for Spectra Optia safety only. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Spectra Optia events are AEs during the study period when the subject received the Spectra Optia.
11138365|NCT01805180|EG001|Reported Event|COBE Spectra|A total of n=42 subjects were randomized to receive a procedure. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Lead-in subjects are never exposed to COBE Spectra per protocol and not included. COBE Spectra events are AEs during the study period when the subject received the COBE Spectra.
11138366|NCT01805297|BG000|Baseline|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, immediately following pars plana vitrectomy."
11138367|NCT01805297|BG001|Baseline|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
11138368|NCT01805297|BG002|Baseline|Total|Total of all reporting groups
11138369|NCT01805297|FG000|Participant Flow|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy."
11138370|NCT01805297|FG001|Participant Flow|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
11138371|NCT01805297|OG000|Outcome|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy."
11138372|NCT01805297|OG001|Outcome|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
11138373|NCT01805297|OG000|Outcome|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, immediately following pars plana vitrectomy."
11138374|NCT01805297|EG000|Reported Event|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy."
11138375|NCT01805297|EG001|Reported Event|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
11138376|NCT01805323|BG000|Baseline|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
11138377|NCT01805323|FG000|Participant Flow|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
11138378|NCT01805323|OG000|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
11138379|NCT01805323|EG000|Reported Event|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
11138380|NCT01805440|BG000|Baseline|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
11138381|NCT01805440|BG001|Baseline|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
11138382|NCT01805440|BG002|Baseline|Healthy Comparison|Subjects seen for screening and baseline scan. No randomization or treatment intervention for subjects enrolled as a Healthy Comparison.
11138383|NCT01805440|BG003|Baseline|Total|Total of all reporting groups
11138384|NCT01805440|FG000|Participant Flow|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
11138385|NCT01805440|FG001|Participant Flow|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
10887411|NCT00500331|FG000|Participant Flow|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
11138386|NCT01805440|FG002|Participant Flow|Healthy Comparison|Subjects seen for screening and baseline scan. No randomization or treatment intervention for subjects enrolled as a Healthy Comparison.
11138387|NCT01805440|OG000|Outcome|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
11138388|NCT01805440|OG001|Outcome|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
11138389|NCT01805440|OG002|Outcome|Healthy Comparison|Subjects did not receive study medication. Subjects were only seen for baseline visit.
11138390|NCT01805440|EG000|Reported Event|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
11138391|NCT01805440|EG001|Reported Event|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
11138392|NCT01805687|BG000|Baseline|Zileuton Extended Release|Zileuton extended release
11138393|NCT01805687|FG000|Participant Flow|Zileuton Extended Release|Zileuton extended release 1200 mg (2 x 600 mg tablets)
11138394|NCT01805687|OG000|Outcome|Zileuton Extended Release|Zileuton extended release
11138395|NCT01805687|EG000|Reported Event|Zileuton Extended Release|Zileuton extended release
11138396|NCT01805791|BG000|Baseline|Placebo|"Placebo, oral tablets, 3 times a day~Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo three times daily for 56 days (8 weeks)."
11138397|NCT01805791|BG001|Baseline|HMPL-004 1800 mg/Day|"1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day~HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times a day (total dose 1800 mg/day) for 56 days (8 weeks)."
11138398|NCT01805791|BG002|Baseline|HMPL-004 2400 mg/Day|"2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times a day~HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times a day (total dose 2400 mg/day) for 56 days (8 weeks)."
11138399|NCT01805791|BG003|Baseline|Total|Total of all reporting groups
11138400|NCT01805791|FG000|Participant Flow|Placebo|"Placebo, oral tablets, three times a day~Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo three times daily for 56 days (8 weeks)."
11138401|NCT01805791|FG001|Participant Flow|HMPL-004 1800 mg/Day|"1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day~HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times daily (total dose 1800 mg/day) for 56 days (8 weeks)."
11138402|NCT01805791|FG002|Participant Flow|HMPL-004 2400 mg/Day|"2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times per day~HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times daily (total dose 2400 mg/day) for 56 days (8 weeks)."
11138403|NCT01805791|OG000|Outcome|HMPL-004 2400 mg/Day|"2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times a day~HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times a day (total dose 2400 mg/day) for 56 days (8 weeks)."
11138404|NCT01805791|OG001|Outcome|HMPL-004 1800 mg/Day|"1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day~HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times a day (total dose 1800 mg/day) for 56 days (8 weeks)."
11138405|NCT01805791|OG002|Outcome|Placebo|"Placebo, oral tablets, 3 times a day~Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo 3 times a day for 56 days (8 weeks)."
11138406|NCT01805791|EG000|Reported Event|HMPL-004 2400 mg/Day|"2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times a day~HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times a day (total dose 2400 mg/day) for 56 days (8 weeks)."
11138407|NCT01805791|EG001|Reported Event|HMPL-004 1800 mg/Day|"1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day~HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times a day (total dose 1800 mg/day) for 56 days (8 weeks)."
11138408|NCT01805791|EG002|Reported Event|Placebo|"Placebo, oral tablets, 3 times a day~Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo 3 times a day for 56 days (8 weeks)."
10879708|NCT00459342|OG000|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11138409|NCT01805882|BG000|Baseline|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
11138410|NCT01805882|BG001|Baseline|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
11138411|NCT01805882|BG002|Baseline|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
11138412|NCT01805882|BG003|Baseline|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
11138413|NCT01805882|BG004|Baseline|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
11138414|NCT01805882|BG005|Baseline|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
11138415|NCT01805882|BG006|Baseline|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
11149733|NCT01872910|BG000|Baseline|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
11138416|NCT01805882|BG007|Baseline|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
11138417|NCT01805882|BG008|Baseline|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
11138418|NCT01805882|BG009|Baseline|Total|Total of all reporting groups
11138419|NCT01805882|FG000|Participant Flow|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
11138420|NCT01805882|FG001|Participant Flow|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
11138421|NCT01805882|FG002|Participant Flow|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
11138422|NCT01805882|FG003|Participant Flow|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
11138423|NCT01805882|FG004|Participant Flow|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
11138424|NCT01805882|FG005|Participant Flow|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
11138425|NCT01805882|FG006|Participant Flow|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
11138426|NCT01805882|FG007|Participant Flow|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
11138427|NCT01805882|FG008|Participant Flow|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
11138428|NCT01805882|OG000|Outcome|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
11138429|NCT01805882|OG001|Outcome|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
11138430|NCT01805882|OG002|Outcome|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
11138431|NCT01805882|OG003|Outcome|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
11138432|NCT01805882|OG004|Outcome|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
11138433|NCT01805882|OG005|Outcome|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
10879709|NCT00459342|EG000|Reported Event|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11138434|NCT01805882|OG006|Outcome|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
11138435|NCT01805882|OG007|Outcome|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
11138436|NCT01805882|OG008|Outcome|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
11138437|NCT01805882|EG000|Reported Event|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
11138438|NCT01805882|EG001|Reported Event|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
11138439|NCT01805882|EG002|Reported Event|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
11138440|NCT01805882|EG003|Reported Event|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
10887412|NCT00500331|FG001|Participant Flow|GSK189075 50 mg|Eligible participants received GSK189075 50 milligram (mg) tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11138441|NCT01805882|EG004|Reported Event|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
11138442|NCT01805882|EG005|Reported Event|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
11138443|NCT01805882|EG006|Reported Event|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
11138444|NCT01805882|EG007|Reported Event|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
11138445|NCT01805882|EG008|Reported Event|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
11138446|NCT01805895|BG000|Baseline|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
11138447|NCT01805895|BG001|Baseline|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
11138448|NCT01805895|BG002|Baseline|Total|Total of all reporting groups
11138449|NCT01805895|FG000|Participant Flow|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
11138450|NCT01805895|FG001|Participant Flow|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
11138451|NCT01805895|OG000|Outcome|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
11138452|NCT01805895|OG001|Outcome|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
11138453|NCT01805895|EG000|Reported Event|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
11138454|NCT01805895|EG001|Reported Event|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
11138455|NCT01806064|BG000|Baseline|P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 1: 8 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138456|NCT01806064|BG001|Baseline|P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 2: 10 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138457|NCT01806064|BG002|Baseline|P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID|Phase 1b Dose Level 3: 10 mg/kg TRC105 weekly during cycle 1 then 15 mg/kg TRC105 every two weeks beginning in cycle 2 in combination with 5 mg Axitinib twice daily
11138458|NCT01806064|BG003|Baseline|P2 Arm A: 5 mg Axitinib BID|Phase 2 Arm A: 5 mg Axitinib twice daily
11138459|NCT01806064|BG004|Baseline|P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 2 Arm B: 10 mg/kg TRC105 weekly + 5 mg Axitinib twice daily
11138460|NCT01806064|BG005|Baseline|Total|Total of all reporting groups
11138461|NCT01806064|FG000|Participant Flow|P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 1: 8 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138462|NCT01806064|FG001|Participant Flow|P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 2: 10 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138463|NCT01806064|FG002|Participant Flow|P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID|Phase 1b Dose Level 3: 10 mg/kg TRC105 weekly during cycle 1 then 15 mg/kg TRC105 every two weeks beginning in cycle 2 in combination with 5 mg Axitinib twice daily
11138464|NCT01806064|FG003|Participant Flow|P2 Arm A: 5 mg Axitinib BID|Phase 2 Arm A: 5 mg Axitinib twice daily
11138465|NCT01806064|FG004|Participant Flow|P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 2 Arm B: 10 mg/kg TRC105 weekly + 5 mg Axitinib twice daily
11138466|NCT01806064|OG000|Outcome|P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 1: 8 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138467|NCT01806064|OG001|Outcome|P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 2: 10 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138468|NCT01806064|OG002|Outcome|P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID|Phase 1b Dose Level 3: 10 mg/kg TRC105 weekly during cycle 1 then 15 mg/kg TRC105 every two weeks beginning in cycle 2 in combination with 5 mg Axitinib twice daily
11138469|NCT01806064|OG000|Outcome|P2 Arm A: 5 mg Axitinib BID|Phase 2 Arm A: 5 mg Axitinib twice daily
11138470|NCT01806064|OG001|Outcome|P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 2 Arm B: 10 mg/kg TRC105 weekly + 5 mg Axitinib twice daily
11138471|NCT01806064|OG001|Outcome|P2 Arm A: 5 mg Axitinib BID|Phase 2 Arm A: 5 mg Axitinib twice daily
11138472|NCT01806064|OG002|Outcome|P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 2 Arm B: 10 mg/kg TRC105 weekly + 5 mg Axitinib twice daily
11138473|NCT01806064|OG003|Outcome|P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 2: 10 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138474|NCT01806064|OG004|Outcome|P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID|Phase 1b Dose Level 3: 10 mg/kg TRC105 weekly during cycle 1 then 15 mg/kg TRC105 every two weeks beginning in cycle 2 in combination with 5 mg Axitinib twice daily
11138475|NCT01806064|EG000|Reported Event|P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 1: 8 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138476|NCT01806064|EG001|Reported Event|P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 1b Dose Level 2: 10 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
11138477|NCT01806064|EG002|Reported Event|P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID|Phase 1b Dose Level 3: 10 mg/kg TRC105 weekly during cycle 1 then 15 mg/kg TRC105 every two weeks beginning in cycle 2 in combination with 5 mg Axitinib twice daily
11138478|NCT01806064|EG003|Reported Event|P2 Arm A: 5 mg Axitinib BID|Phase 2 Arm A: 5 mg Axitinib twice daily
11138479|NCT01806064|EG004|Reported Event|P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID|Phase 2 Arm B: 10 mg/kg TRC105 weekly + 5 mg Axitinib twice daily
11138480|NCT01806168|BG000|Baseline|Low-frequency (1 Hz) rTMS|"Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138481|NCT01806168|BG001|Baseline|High-frequency (10 Hz) rTMS|"High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138482|NCT01806168|BG002|Baseline|Sham rTMS|"Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138483|NCT01806168|BG003|Baseline|Total|Total of all reporting groups
11138484|NCT01806168|FG000|Participant Flow|Low-frequency (1 Hz) rTMS|"Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138485|NCT01806168|FG001|Participant Flow|High-frequency (10 Hz) rTMS|"High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138486|NCT01806168|FG002|Participant Flow|Sham rTMS|"Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138487|NCT01806168|OG000|Outcome|Low-frequency (1 Hz) rTMS|"Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138488|NCT01806168|OG001|Outcome|High-frequency (10 Hz) rTMS|"High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138489|NCT01806168|OG002|Outcome|Sham rTMS|"Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138490|NCT01806168|OG000|Outcome|Low-frequency (1 Hz) rTMS|"Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138491|NCT01806168|OG001|Outcome|High-frequency (10 Hz) rTMS|"High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138492|NCT01806168|OG002|Outcome|Sham rTMS|"Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138493|NCT01806168|EG000|Reported Event|Low-frequency (1 Hz) rTMS|"Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138494|NCT01806168|EG001|Reported Event|High-frequency (10 Hz) rTMS|"High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138495|NCT01806168|EG002|Reported Event|Sham rTMS|"Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.~rTMS: Magstim Super Rapid-2"
11138496|NCT01806259|BG000|Baseline|Ketorolac 30 mg|"Active drug to be compared with placebo~Ketorolac 30 mg IV"
11138497|NCT01806259|BG001|Baseline|NaCl 0.9% 3mL|Ketorolac 30 mg IV
11138498|NCT01806259|BG002|Baseline|Total|Total of all reporting groups
11138499|NCT01806259|FG000|Participant Flow|Ketorolac 30 mg|"Active drug to be compared with placebo~Ketorolac 30 mg IV"
11138500|NCT01806259|FG001|Participant Flow|NaCl 0.9% 3mL|Placebo
11138501|NCT01806259|OG000|Outcome|Ketorolac 30 mg|"Active drug to be compared with placebo~Ketorolac 30 mg IV"
11138502|NCT01806259|OG001|Outcome|NaCl 0.9% 3mL|Ketorolac 30 mg IV
11138503|NCT01806259|OG001|Outcome|NaCl 0.9% 3mL|Placebo looking like the Active drug
11138504|NCT01806259|EG000|Reported Event|Ketorolac 30 mg|"Active drug to be compared with placebo~Ketorolac 30 mg IV"
11138505|NCT01806259|EG001|Reported Event|NaCl 0.9% 3mL|Placebo looking like the Active drug
11138506|NCT01806298|BG000|Baseline|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
11138507|NCT01806298|FG000|Participant Flow|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
11138508|NCT01806298|OG000|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
11138509|NCT01806298|EG000|Reported Event|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
11138510|NCT01806389|BG000|Baseline|Buprenorphine Maintained Lactating Women|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
11138511|NCT01806389|FG000|Participant Flow|Buprenorphine Maintained Lactating Women|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
11138512|NCT01806389|OG000|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 2|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 2
11138513|NCT01806389|OG001|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 3|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 3
11138514|NCT01806389|OG002|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 4|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 4
11138515|NCT01806389|OG003|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 14
11138516|NCT01806389|OG004|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 30|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 30
11138517|NCT01806389|OG000|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 2|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing breast milk for analysis on day 2
11138518|NCT01806389|OG001|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 3|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 3
11138519|NCT01806389|OG002|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 4|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 4
11138520|NCT01806389|OG003|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 14
11138521|NCT01806389|OG004|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 30|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 30
11138522|NCT01806389|OG000|Outcome|INFANT PLASMA Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing INFANT PLASMA for analysis on day 14
11138523|NCT01806389|EG000|Reported Event|Buprenorphine|Buprenorphine maintained women at delivery of their infant
11138524|NCT01806506|BG000|Baseline|Laparoscopic Sleeve Gastrectomy|"The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.~Laparoscopic sleeve gastrectomy: Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie."
11138525|NCT01806506|BG001|Baseline|Roux-en-Y Gastric Bypass|"The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.~Roux-en-Y Gastric Bypass: Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz."
11138526|NCT01806506|BG002|Baseline|Total|Total of all reporting groups
11138527|NCT01806506|FG000|Participant Flow|Laparoscopic Sleeve Gastrectomy|"The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.~Laparoscopic sleeve gastrectomy: Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie."
11138528|NCT01806506|FG001|Participant Flow|Roux-en-Y Gastric Bypass|"The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.~Roux-en-Y Gastric Bypass: Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz."
11138529|NCT01806506|OG000|Outcome|Laparoscopic Sleeve Gastrectomy|"The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.~Laparoscopic sleeve gastrectomy: Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie."
11138530|NCT01806506|OG001|Outcome|Roux-en-Y Gastric Bypass|"The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.~Roux-en-Y Gastric Bypass: Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz."
11138531|NCT01806506|EG000|Reported Event|Laparoscopic Sleeve Gastrectomy|"The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.~Laparoscopic sleeve gastrectomy: Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie."
11138532|NCT01806506|EG001|Reported Event|Roux-en-Y Gastric Bypass|"The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.~Roux-en-Y Gastric Bypass: Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz."
11138533|NCT01806545|BG000|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
11138534|NCT01806545|BG001|Baseline|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
11138535|NCT01806545|BG002|Baseline|Total|Total of all reporting groups
11138536|NCT01806545|FG000|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
11138537|NCT01806545|FG001|Participant Flow|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
11138538|NCT01806545|OG000|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
11138539|NCT01806545|OG001|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
11138540|NCT01806545|EG000|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
11138541|NCT01806545|EG001|Reported Event|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
11138542|NCT01806571|BG000|Baseline|Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)|INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
11138543|NCT01806571|FG000|Participant Flow|Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)|INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
11138544|NCT01806571|OG000|Outcome|Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)|INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
11149734|NCT01872910|BG001|Baseline|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
11149735|NCT01872910|BG002|Baseline|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
11149736|NCT01872910|BG003|Baseline|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
11149737|NCT01872910|BG004|Baseline|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
11149738|NCT01872910|BG005|Baseline|Pre-Part B - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement.
11138545|NCT01806571|EG000|Reported Event|Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)|INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
11138546|NCT01806584|BG000|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
11138547|NCT01806584|BG001|Baseline|SRM003|Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period.
11138548|NCT01806584|BG002|Baseline|Total|Total of all reporting groups
11138549|NCT01806584|FG000|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
11138550|NCT01806584|FG001|Participant Flow|SRM003|Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period.
11138551|NCT01806584|OG000|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
11138552|NCT01806584|OG001|Outcome|SRM003|Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period.
11138553|NCT01806584|EG000|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
11138554|NCT01806584|EG001|Reported Event|SRM003|Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period.
11138555|NCT01806597|BG000|Baseline|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
11138556|NCT01806597|BG001|Baseline|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
11138557|NCT01806597|BG002|Baseline|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
11138558|NCT01806597|BG003|Baseline|Total|Total of all reporting groups
11138559|NCT01806597|FG000|Participant Flow|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
11138560|NCT01806597|FG001|Participant Flow|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
11138561|NCT01806597|FG002|Participant Flow|Placebo - AIN457 150 mg|all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization
11138562|NCT01806597|FG003|Participant Flow|Placebo - AIN457 300mg|all placebo patients who were re-randomized to AIN457 300 mg at re-randomization
11138563|NCT01806597|FG004|Participant Flow|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
11138564|NCT01806597|FG005|Participant Flow|Any AIN457 Dose|All patients who were injected with AIN457
11138565|NCT01806597|OG000|Outcome|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
11138566|NCT01806597|OG001|Outcome|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
11138567|NCT01806597|OG002|Outcome|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
11138568|NCT01806597|OG002|Outcome|Placebo - AIN457 150 mg|all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization.
11138569|NCT01806597|OG003|Outcome|Placebo - AIN457 300 mg|all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.
11138570|NCT01806597|OG004|Outcome|Placebo|Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks
11138571|NCT01806597|OG002|Outcome|Placebo - AIN 150mg|all placebo patients who were re-randomized to AIN457 150 mg at re-randomization
11138572|NCT01806597|OG003|Outcome|Placebo - AIN457 300mg|all placebo patients who were re-randomized to AIN457 300 mg at re-randomization
11009260|NCT01100944|OG000|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009261|NCT01100944|OG000|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009262|NCT01100944|OG000|Outcome|Thymic Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
11009263|NCT01100944|OG001|Outcome|Thymoma Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
11009264|NCT01100944|OG002|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
11009265|NCT01100944|OG000|Outcome|All Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
11009266|NCT01100944|OG000|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD) and was utilized in the expansion phase (phase 2)."
11009267|NCT01100944|OG001|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009268|NCT01100944|OG002|Outcome|All Participants|All participants who had at least one dose of belinostat.
11009269|NCT01100944|OG000|Outcome|Thymic Particpants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
11138573|NCT01806597|EG000|Reported Event|Any AIN457 150 mg|AIN457 150mg subcutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
11138574|NCT01806597|EG001|Reported Event|Any AIN457 300 mg|AIN457 300mg subcutaneous ((2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
11009270|NCT01100944|OG001|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
11009271|NCT01100944|OG002|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.~PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
11009272|NCT01100944|OG000|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
11009273|NCT01100944|OG000|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009274|NCT01100944|OG000|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009275|NCT01100944|OG001|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009276|NCT01100944|OG000|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009277|NCT01100944|OG000|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
11009278|NCT01100944|EG000|Reported Event|All Participants|All participants who had at least one dose of belinostat.
11009279|NCT01101022|BG000|Baseline|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
11009280|NCT01101022|BG001|Baseline|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
11009281|NCT01101022|BG002|Baseline|Total|Total of all reporting groups
11138575|NCT01806597|EG002|Reported Event|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
11149739|NCT01872910|BG006|Baseline|Total|Total of all reporting groups
11138576|NCT01806597|EG003|Reported Event|Any AIN457 Dose|All patients who were injected with AIN457
11138577|NCT01806623|BG000|Baseline|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
11138578|NCT01806623|FG000|Participant Flow|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
11138579|NCT01806623|OG000|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
11138580|NCT01806623|EG000|Reported Event|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
11138581|NCT01806662|BG000|Baseline|All Study Participants|"Since there is a crossover design, each participant will be in the Treatment Arm (Ustekinumab first, Then Placebo) or Placebo Arm (Placebo first, Then Ustekinumab) for 16 weeks of the study. They will crossover to the other treatment at week 16 for 16 weeks (32 weeks total).~Placebo: Injection of placebo Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23"
11138582|NCT01806662|FG000|Participant Flow|Treatment Arm (Ustekinumab First, Then Palcebo)|"Since there is a crossover design, each patient will be in the treatment arm for 32 weeks (16 weeks on Ustekinumab, then 16 weeks on Placebo) of the study.~Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23"
11138583|NCT01806662|FG001|Participant Flow|Placebo Arm (Placebo First, Then Ustekinumab)|"Since there is a crossover design, each patient will be in the placebo arm for 16 weeks of the study. If a patient begins in the placebo arm, they will switch over to the treatment arm at week 16 (for 16 weeks).~Placebo: Injection of placebo"
11138584|NCT01806662|OG000|Outcome|Treatment Arm (Ustekinumab First, Then Palcebo)|"Since there is a crossover design, each patient will be in the treatment arm for 16 weeks of the study.~Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23"
11138585|NCT01806662|OG001|Outcome|Placebo Arm (Placebo First, Then Ustekinumab)|"Since there is a crossover design, each patient will be in the placebo arm for 16 weeks of the study. If a patient begins in the placebo arm, they will switch over to the treatment arm at week 16.~Placebo: Injection of placebo"
11138586|NCT01806662|EG000|Reported Event|Ustekinumab|"Participants who received Ustekinumab injection for 16 weeks.~Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23"
11138587|NCT01806662|EG001|Reported Event|Placebo|"Participants who received Placebo injection for 16 weeks.~Placebo: Injection of placebo"
11138588|NCT01806675|BG000|Baseline|Glioblastoma Multiforme (GBM)|"Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138589|NCT01806675|BG001|Baseline|Gynecological Cancers|"Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138590|NCT01806675|BG002|Baseline|Renal Cell Cancer (RCC)|"Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138591|NCT01806675|BG003|Baseline|Total|Total of all reporting groups
11138592|NCT01806675|FG000|Participant Flow|Glioblastoma Multiforme (GBM)|"Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138593|NCT01806675|FG001|Participant Flow|Gynecological Cancers|"Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138594|NCT01806675|FG002|Participant Flow|Renal Cell Cancer (RCC)|"Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138595|NCT01806675|OG000|Outcome|Glioblastoma Multiforme (GBM)|"Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138596|NCT01806675|OG001|Outcome|Gynecological Cancers|"Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
10887413|NCT00500331|FG002|Participant Flow|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11138597|NCT01806675|OG002|Outcome|Renal Cell Cancer (RCC)|"Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138598|NCT01806675|EG000|Reported Event|Glioblastoma Multiforme (GBM)|"Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138599|NCT01806675|EG001|Reported Event|Gynecological Cancers|"Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138600|NCT01806675|EG002|Reported Event|Renal Cell Cancer (RCC)|"Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)~18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan~18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2."
11138601|NCT01806688|BG000|Baseline|Seed Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #1 is a gluten-free high protein snack comprised of a 30g serving of buckwheat groats. The placebo comparator reference product is a gluten-free snack with similar energy density, but 1/2 the protein as snack #1, comprised of a 32g serving of corn nuts. The placebo comparator non-caloric control is water.
11138602|NCT01806688|BG001|Baseline|Pita Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of buckwheat and pinto bean flour pita bread. The placebo comparator reference product is a gluten-free snack with similar energy density, but less protein and fibre than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
11138603|NCT01806688|BG002|Baseline|Total|Total of all reporting groups
11138604|NCT01806688|FG000|Participant Flow|Seed Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #1 is a gluten-free high protein snack comprised of a 30g serving of buckwheat groats. The placebo comparator reference product is a gluten-free snack with similar energy density, but 1/2 the protein as snack #1, comprised of a 32g serving of corn nuts. The placebo comparator non-caloric control is water.
11138605|NCT01806688|FG001|Participant Flow|Pita Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of a buckwheat and pinto bean flour pita bread. The placebo comparator reference product is a gluten-free snack with similar energy density, but less protein and fibre than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
11138606|NCT01806688|OG000|Outcome|Seed Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #1 is a gluten-free high protein snack comprised of a 30g serving of buckwheat groats. The placebo comparator reference product is a gluten-free snack with similar energy density, but 1/2 the protein as snack #1, comprised of a 32g serving of corn nuts. The placebo comparator non-caloric control is water.
11138607|NCT01806688|OG001|Outcome|Pita Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of buckwheat and pinto bean flour pita bread. The placebo comparator reference product is a gluten-free snack with similar energy density but less protein and fiber than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
11138608|NCT01806688|OG001|Outcome|Pita Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of buckwheat pita. The placebo comparator reference product is a gluten-free snack with similar energy density, but less protein and fibre than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
11138609|NCT01806688|OG000|Outcome|Experimental Snack #1|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #1 is a gluten-free high protein snack comprised of a 30g serving of buckwheat groats. The placebo comparator reference product is a gluten-free snack with similar energy density, but 1/2 the protein as snack #1, comprised of a 32g serving of corn nuts. The placebo comparator non-caloric control is water.
11138610|NCT01806688|OG001|Outcome|Experimental Snack #2|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of buckwheat and pinto bean flour pita bread. The placebo comparator reference product is a gluten-free snack with similar energy density, but less protein and fibre than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
11149740|NCT01872910|FG000|Participant Flow|Part A - LY3023703|LY3023703: Administered orally once as a 30-milligrams (mg) capsule post dental surgery.
11138611|NCT01806688|EG000|Reported Event|Seed Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #1 is a gluten-free high protein snack comprised of a 30g serving of buckwheat groats. The placebo comparator reference product is a gluten-free snack with similar energy density, but 1/2 the protein as snack #1, comprised of a 32g serving of corn nuts. The placebo comparator non-caloric control is water.
11138612|NCT01806688|EG001|Reported Event|Pita Study|One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control. The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of a buckwheat and pinto bean flour pita bread. The placebo comparator reference product is a gluten-free snack with similar energy density, but less protein and fibre than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
11138613|NCT01806714|BG000|Baseline|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
11138614|NCT01806714|BG001|Baseline|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
11138615|NCT01806714|BG002|Baseline|Total|Total of all reporting groups
11138616|NCT01806714|FG000|Participant Flow|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
11138617|NCT01806714|FG001|Participant Flow|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
11138618|NCT01806714|OG000|Outcome|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
11138619|NCT01806714|OG001|Outcome|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
11138620|NCT01806714|EG000|Reported Event|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
11138621|NCT01806714|EG001|Reported Event|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
11138622|NCT01806740|BG000|Baseline|Gadoterate Meglumine|All patients who received gadoterate meglumine.
11138623|NCT01806740|FG000|Participant Flow|Gadoterate Meglumine|All patients who received gadoterate meglumine.
11138624|NCT01806740|OG000|Outcome|Baseline|DCE-MRI perfusion parameters assessed at baseline (initiation of the sorafenib treatment)
11138625|NCT01806740|OG001|Outcome|Week 1|DCE-MRI perfusion parameters assessed one week after initiation of the sorafenib treatment
11138626|NCT01806740|OG002|Outcome|Week 2|DCE-MRI perfusion parameters assessed two weeks after initiation of the sorafenib treatment
11138627|NCT01806740|OG000|Outcome|Baseline|DCE-MRI perfusion parameters assessed at baseline (initiation of sorafenib treatment)
11138628|NCT01806740|EG000|Reported Event|Gadoterate Meglumine|All patients who received gadoterate meglumine.
11138629|NCT01806779|BG000|Baseline|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
11138630|NCT01806779|BG001|Baseline|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
11138631|NCT01806779|BG002|Baseline|Total|Total of all reporting groups
11149741|NCT01872910|FG001|Participant Flow|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
11149742|NCT01872910|FG002|Participant Flow|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
10887414|NCT00500331|FG003|Participant Flow|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11009282|NCT01101022|FG000|Participant Flow|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
11009283|NCT01101022|FG001|Participant Flow|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
11009284|NCT01101022|OG000|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
11009285|NCT01101022|OG001|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
11009286|NCT01101022|EG000|Reported Event|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
11009287|NCT01101022|EG001|Reported Event|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
11009288|NCT01101035|BG000|Baseline|Febuxostat|Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
11009289|NCT01101035|BG001|Baseline|Allopurinol|Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance [eCLcr] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but <60 mL/min).
11009290|NCT01101035|BG002|Baseline|Total|Total of all reporting groups
11009291|NCT01101035|FG000|Participant Flow|Febuxostat|Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
11009292|NCT01101035|FG001|Participant Flow|Allopurinol|Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance [eCLcr] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but <60 mL/min).
11009293|NCT01101035|OG000|Outcome|Febuxostat|Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
11009294|NCT01101035|OG001|Outcome|Allopurinol|Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance [eCLcr] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but <60 mL/min).
11009295|NCT01101035|EG000|Reported Event|Febuxostat|Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
11009296|NCT01101035|EG001|Reported Event|Allopurinol|Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance [eCLcr] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but <60 mL/min).
11009297|NCT01101061|BG000|Baseline|Japanese Women: Placebo|Japanese participants received a single subcutaneous injection of placebo on day 1.
11009298|NCT01101061|BG001|Baseline|Japanese Women: Romosozumab 1 mg/kg|Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
11009299|NCT01101061|BG002|Baseline|Japanese Women: Romosozumab 3 mg/kg|Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
10879710|NCT00459355|BG000|Baseline|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
11009300|NCT01101061|BG003|Baseline|Japanese Women: Romosozumab 5 mg/kg|Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
11009301|NCT01101061|BG004|Baseline|Non-Japanese Women: Placebo|Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
11009302|NCT01101061|BG005|Baseline|Non-Japanese Women: Romosozumab 3 mg/kg|Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009303|NCT01101061|BG006|Baseline|Total|Total of all reporting groups
11009304|NCT01101061|FG000|Participant Flow|Japanese Women: Placebo|Japanese participants received a single subcutaneous injection of placebo on day 1.
11009305|NCT01101061|FG001|Participant Flow|Japanese Women: Romosozumab 1 mg/kg|Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
10879711|NCT00459355|BG001|Baseline|Checklist|Received conventional home safety checklist
11009306|NCT01101061|FG002|Participant Flow|Japanese Women: Romosozumab 3 mg/kg|Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009307|NCT01101061|FG003|Participant Flow|Japanese Women: Romosozumab 5 mg/kg|Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
11009308|NCT01101061|FG004|Participant Flow|Non-Japanese Women: Placebo|Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
11009309|NCT01101061|FG005|Participant Flow|Non-Japanese Women: Romosozumab 3 mg/kg|Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009310|NCT01101061|OG000|Outcome|Japanese Women: Placebo|Japanese participants received a single subcutaneous injection of placebo on day 1.
11138632|NCT01806779|FG000|Participant Flow|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
11138633|NCT01806779|FG001|Participant Flow|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
11138634|NCT01806779|FG002|Participant Flow|Nicotine Patches Only|These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
11138635|NCT01806779|OG000|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
11138636|NCT01806779|OG001|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
11138637|NCT01806779|EG000|Reported Event|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
11138638|NCT01806779|EG001|Reported Event|Chantix + Zyban|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
11138639|NCT01806779|EG002|Reported Event|Nicotine Patch|All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.
11138640|NCT01806857|BG000|Baseline|All Study Participants|
11138641|NCT01806857|FG000|Participant Flow|Nuedexta Then Matching Placebo|"Subjects in this arm will receive treatment with Nuedexta first for 28 days (±3 days) and then crossed over to receive treatment with matching placebo for 28 days (±3 days).~Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days~Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days"
11138642|NCT01806857|FG001|Participant Flow|Matching Placebo Then Nuedexta|"Subjects in this arm will receive treatment with matching placebo first for 28 days (±3 days) and then crossed over to receive treatment with Nuedexta for 28 days (±3 days).~Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days~Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days"
11138643|NCT01806857|OG000|Outcome|Active Drug (Neudexta)|
11138644|NCT01806857|OG001|Outcome|Matching Placebo|
11138645|NCT01806857|OG000|Outcome|Active Drug (Nuedexta)|
11138646|NCT01806857|EG000|Reported Event|Active Drug (Neudexta)|Includes all subjects that took the active drug (Neudexta)
11138647|NCT01806857|EG001|Reported Event|Matching Placebo|Includes all subjects that took matching placebo
11138648|NCT01806896|BG000|Baseline|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
11138649|NCT01806896|BG001|Baseline|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
10879712|NCT00459355|BG002|Baseline|Total|Total of all reporting groups
10887415|NCT00500331|FG004|Participant Flow|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11138650|NCT01806896|BG002|Baseline|Total|Total of all reporting groups
11138651|NCT01806896|FG000|Participant Flow|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
11138652|NCT01806896|FG001|Participant Flow|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
11138653|NCT01806896|OG000|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
11138654|NCT01806896|OG001|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
11138655|NCT01806896|EG000|Reported Event|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
11138656|NCT01806896|EG001|Reported Event|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
11138657|NCT01807000|BG000|Baseline|[14C] PRUCALOPRIDE SUCCINATE|
11138658|NCT01807000|FG000|Participant Flow|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
11138659|NCT01807000|OG000|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
11138660|NCT01807000|EG000|Reported Event|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
11138661|NCT01807026|BG000|Baseline|Cohort A: 70 mg LY2886721|Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138662|NCT01807026|BG001|Baseline|Cohort A: Placebo|Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).
11138663|NCT01807026|BG002|Baseline|Cohort B: 70 mg LY2886721|Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138664|NCT01807026|BG003|Baseline|Cohort B: Placebo|Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
10879713|NCT00459355|FG000|Participant Flow|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
11138665|NCT01807026|BG004|Baseline|Cohort C: 280 mg LY2886721|Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
11138666|NCT01807026|BG005|Baseline|Cohort C: Placebo|Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).
11138667|NCT01807026|BG006|Baseline|Total|Total of all reporting groups
11138668|NCT01807026|FG000|Participant Flow|Cohort A: 70 mg LY2886721|Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721.
11138669|NCT01807026|FG001|Participant Flow|Cohort A: Placebo|Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).
10879714|NCT00459355|FG001|Participant Flow|Checklist|Group receives conventional home safety checklist
11009311|NCT01101061|OG001|Outcome|Japanese Women: Romosozumab 1 mg/kg|Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
11138670|NCT01807026|FG002|Participant Flow|Cohort B: 70 mg LY2886721|Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138671|NCT01807026|FG003|Participant Flow|Cohort B: Placebo|Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
11138672|NCT01807026|FG004|Participant Flow|Cohort C: 280 mg LY2886721|Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
11138673|NCT01807026|FG005|Participant Flow|Cohort C: Placebo|Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).
11138674|NCT01807026|OG000|Outcome|Cohort A: 70 mg LY2886721|Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138675|NCT01807026|OG001|Outcome|Cohort B: 70 mg LY2886721|Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138676|NCT01807026|OG002|Outcome|Cohort C: 280 mg LY2886721|Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
11138677|NCT01807026|OG000|Outcome|Cohort A: 70 mg LY2886721|Participants with Alzheimer's received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138678|NCT01807026|OG001|Outcome|Cohort A: Placebo|Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).
11138679|NCT01807026|OG002|Outcome|Cohort B: 70 mg LY2886721|Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138680|NCT01807026|OG003|Outcome|Cohort C: 280 mg LY2886721|Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
11138681|NCT01807026|OG004|Outcome|Cohorts B and C: Placebo|Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
11138682|NCT01807026|OG001|Outcome|Cohort A: Placebo|Participants with Alzheimer's received a single, oral dose of LY2886721-matching placebo (1 capsule).
11138683|NCT01807026|OG003|Outcome|Cohort B: Placebo|Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
11138684|NCT01807026|OG000|Outcome|Cohort C: 280 mg LY2886721|Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
11138685|NCT01807026|EG000|Reported Event|Cohort A: 70 mg LY2886721|Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138686|NCT01807026|EG001|Reported Event|Cohort A: Placebo|Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).
11138687|NCT01807026|EG002|Reported Event|Cohort B: 70 mg LY2886721|Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
11138688|NCT01807026|EG003|Reported Event|Cohort B: Placebo|Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
11138689|NCT01807026|EG004|Reported Event|Cohort C: 280 mg LY2886721|Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
11138690|NCT01807026|EG005|Reported Event|Cohort C: Placebo|Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).
11138691|NCT01807065|BG000|Baseline|Arm A (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells.~sipuleucel-T: Given IV~laboratory biomarker analysis: Correlative studies"
11138692|NCT01807065|BG001|Baseline|Arm B (Radiation Therapy, Sipuleucel-T)|"Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A.~sipuleucel-T: Given IV~external beam radiation therapy: Undergo external beam radiation therapy~laboratory biomarker analysis: Correlative studies"
11138693|NCT01807065|BG002|Baseline|Total|Total of all reporting groups
11138694|NCT01807065|FG000|Participant Flow|Arm A (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells.~sipuleucel-T: Given IV~laboratory biomarker analysis: Correlative studies"
11138695|NCT01807065|FG001|Participant Flow|Arm B (Radiation Therapy, Sipuleucel-T)|"Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A.~sipuleucel-T: Given IV~external beam radiation therapy: Undergo external beam radiation therapy~laboratory biomarker analysis: Correlative studies"
11138696|NCT01807065|OG000|Outcome|Arm A (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells.~sipuleucel-T: Given IV~laboratory biomarker analysis: Correlative studies"
11138697|NCT01807065|OG001|Outcome|Arm B (Radiation Therapy, Sipuleucel-T)|"Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A.~sipuleucel-T: Given IV~external beam radiation therapy: Undergo external beam radiation therapy~laboratory biomarker analysis: Correlative studies"
11138698|NCT01807065|EG000|Reported Event|Arm A (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells.~sipuleucel-T: Given IV~laboratory biomarker analysis: Correlative studies"
11138699|NCT01807065|EG001|Reported Event|Arm B (Radiation Therapy, Sipuleucel-T)|"Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A.~sipuleucel-T: Given IV~external beam radiation therapy: Undergo external beam radiation therapy~laboratory biomarker analysis: Correlative studies"
11138700|NCT01807091|BG000|Baseline|Treatment (Chemotherapy)|Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
11138701|NCT01807091|FG000|Participant Flow|Treatment (Chemotherapy)|Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
11138702|NCT01807091|OG000|Outcome|Treatment (Chemotherapy)|Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
11138703|NCT01807091|EG000|Reported Event|Treatment (Chemotherapy)|Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
11149743|NCT01872910|FG003|Participant Flow|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
11149744|NCT01872910|FG004|Participant Flow|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
11149745|NCT01872910|FG005|Participant Flow|Pre-Part B - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement. Prior to Part B, there was a technique transfer and training conducted to allow the site to develop proficiency in dialysate placement, collection and maintenance techniques.
11149746|NCT01872910|OG000|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
11149747|NCT01872910|OG001|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
11149748|NCT01872910|OG002|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
11149749|NCT01872910|OG003|Outcome|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
11149750|NCT01872910|OG004|Outcome|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
11149751|NCT01872910|EG000|Reported Event|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
11149752|NCT01872910|EG001|Reported Event|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
11149753|NCT01872910|EG002|Reported Event|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
11138704|NCT01807104|BG000|Baseline|Direct Anterior Approach|Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.
11138705|NCT01807104|BG001|Baseline|Postero-Lateral Approach|Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.
11138706|NCT01807104|BG002|Baseline|Total|Total of all reporting groups
11138707|NCT01807104|FG000|Participant Flow|Direct Anterior Approach|Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.
11138708|NCT01807104|FG001|Participant Flow|Postero-Lateral Approach|Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.
11138709|NCT01807104|OG000|Outcome|Direct Anterior Approach|Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.
11138710|NCT01807104|OG001|Outcome|Postero-Lateral Approach|Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.
11138711|NCT01807104|EG000|Reported Event|Direct Anterior Approach|Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.
11138712|NCT01807104|EG001|Reported Event|Postero-Lateral Approach|Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.
11138713|NCT01807156|BG000|Baseline|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
11149754|NCT01872910|EG003|Reported Event|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
11138714|NCT01807156|FG000|Participant Flow|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
11138715|NCT01807156|OG000|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
11138716|NCT01807156|EG000|Reported Event|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
11138717|NCT01807221|BG000|Baseline|Eplerenone (INSPRA®)|Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
11138718|NCT01807221|BG001|Baseline|Finerenone (BAY94-8862) 2.5-5 mg OD|Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138719|NCT01807221|BG002|Baseline|Finerenone (BAY94-8862) 5-10 mg OD|Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138720|NCT01807221|BG003|Baseline|Finerenone (BAY94-8862) 7.5-15 mg OD|Finerenone 7.5 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 15 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138721|NCT01807221|BG004|Baseline|Finerenone (BAY94-8862) 10-20 mg OD|Finerenone 10 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138722|NCT01807221|BG005|Baseline|Finerenone (BAY94-8862) 15-20 mg OD|Finerenone 15 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138723|NCT01807221|BG006|Baseline|Total|Total of all reporting groups
11138724|NCT01807221|FG000|Participant Flow|Eplerenone (INSPRA®)|Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
11138725|NCT01807221|FG001|Participant Flow|Finerenone (BAY94-8862) 2.5-5 mg OD|Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138726|NCT01807221|FG002|Participant Flow|Finerenone (BAY94-8862) 5-10 mg OD|Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138727|NCT01807221|FG003|Participant Flow|Finerenone (BAY94-8862) 7.5-15 mg OD|Finerenone 7.5 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 15 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138728|NCT01807221|FG004|Participant Flow|Finerenone (BAY94-8862) 10-20 mg OD|Finerenone 10 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138729|NCT01807221|FG005|Participant Flow|Finerenone (BAY94-8862) 15-20 mg OD|Finerenone 15 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138730|NCT01807221|OG000|Outcome|Eplerenone (INSPRA®)|Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
11138731|NCT01807221|OG001|Outcome|Finerenone (BAY94-8862) 2.5-5 mg OD|Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138732|NCT01807221|OG002|Outcome|Finerenone (BAY94-8862) 5-10 mg OD|Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138733|NCT01807221|OG003|Outcome|Finerenone (BAY94-8862) 7.5-15 mg OD|Finerenone 7.5 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 15 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
10887416|NCT00500331|FG005|Participant Flow|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11009312|NCT01101061|OG002|Outcome|Japanese Women: Romosozumab 3 mg/kg|Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009313|NCT01101061|OG003|Outcome|Japanese Women: Romosozumab 5 mg/kg|Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
11009314|NCT01101061|OG004|Outcome|Non-Japanese Women: Placebo|Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
11009315|NCT01101061|OG005|Outcome|Non-Japanese Women: Romosozumab 3 mg/kg|Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009316|NCT01101061|OG000|Outcome|Japanese Women: Romosozumab 1 mg/kg|Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
11009317|NCT01101061|OG001|Outcome|Japanese Women: Romosozumab 3 mg/kg|Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009318|NCT01101061|OG002|Outcome|Japanese Women: Romosozumab 5 mg/kg|Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
11009319|NCT01101061|OG003|Outcome|Non-Japanese Women: Romosozumab 3 mg/kg|Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009320|NCT01101061|EG000|Reported Event|Japanese Women: Placebo|Japanese participants received a single subcutaneous injection of placebo on day 1.
11138734|NCT01807221|OG004|Outcome|Finerenone (BAY94-8862) 10-20 mg OD|Finerenone 10 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138735|NCT01807221|OG005|Outcome|Finerenone (BAY94-8862) 15-20 mg OD|Finerenone 15 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
10887417|NCT00500331|FG006|Participant Flow|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
11009321|NCT01101061|EG001|Reported Event|Japanese Women: Romosozumab 1 mg/kg|Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
11009322|NCT01101061|EG002|Reported Event|Japanese Women: Romosozumab 3 mg/kg|Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009323|NCT01101061|EG003|Reported Event|Japanese Women: Romosozumab 5 mg/kg|Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
11009324|NCT01101061|EG004|Reported Event|Non-Japanese Women: Placebo|Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
11009325|NCT01101061|EG005|Reported Event|Non-Japanese Women: Romosozumab 3 mg/kg|Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
11009326|NCT01101100|BG000|Baseline|Open Label|AMG 827: 210 mg SC or 140 mg SC
11009327|NCT01101100|FG000|Participant Flow|Open Label AMG 827|AMG 827: 210 mg SC or 140 mg SC
11009328|NCT01101100|OG000|Outcome|Open Label AMG 827|AMG 827: 210 mg SC or 140 mg SC
11009329|NCT01101100|OG000|Outcome|Open Label|AMG 827: 210 mg SC or 140 mg SC
11009330|NCT01101100|EG000|Reported Event|Open Label AMG 827|AMG 827: 210 mg SC or 140 mg SC
11009331|NCT01101165|BG000|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
11009332|NCT01101165|FG000|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
11009333|NCT01101165|FG001|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
11009334|NCT01101165|OG000|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009335|NCT01101165|OG001|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009336|NCT01101165|EG000|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009337|NCT01101165|EG001|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009338|NCT01101178|BG000|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
11009339|NCT01101178|FG000|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
11009340|NCT01101178|FG001|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
11009341|NCT01101178|OG000|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009342|NCT01101178|OG001|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
11009343|NCT01101178|EG000|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
11138736|NCT01807221|EG000|Reported Event|Eplerenone (INSPRA®)|Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
11138737|NCT01807221|EG001|Reported Event|Finerenone(BAY94-8862) 2.5-5 mg OD|Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo-matched to Eplerenone capsule OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138738|NCT01807221|EG002|Reported Event|Finerenone (BAY94-8862) 5-10 mg OD|Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138739|NCT01807221|EG003|Reported Event|Finerenone (BAY94-8862) 7.5-15 mg OD|Finerenone 7.5 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 15 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138740|NCT01807221|EG004|Reported Event|Finerenone (BAY94-8862) 10-20 mg OD|Finerenone 10 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138741|NCT01807221|EG005|Reported Event|Finerenone (BAY94-8862) 15-20 mg OD|Finerenone 15 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
11138742|NCT01807234|BG000|Baseline|Ketorolac Then Sumatriptan Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
11138743|NCT01807234|BG001|Baseline|Ketorolac Then Placebo Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
11138744|NCT01807234|BG002|Baseline|Sumatriptan Then Ketorolac Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
11138745|NCT01807234|BG003|Baseline|Sumatriptan Then Placebo Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
11138746|NCT01807234|BG004|Baseline|Placebo Then Ketorolac Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
11138747|NCT01807234|BG005|Baseline|Placebo Then Sumatriptan Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
11138748|NCT01807234|BG006|Baseline|Total|Total of all reporting groups
11138749|NCT01807234|FG000|Participant Flow|Ketorolac Then Sumatriptan Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
11138750|NCT01807234|FG001|Participant Flow|Kerorolac Then Placebo Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
11138751|NCT01807234|FG002|Participant Flow|Sumatriptan Then Ketorolac Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
11138752|NCT01807234|FG003|Participant Flow|Sumatriptan Then Placebo Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
11138753|NCT01807234|FG004|Participant Flow|Placebo Then Ketorolac Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
11138754|NCT01807234|FG005|Participant Flow|Placebo Then Sumatriptan Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
11138755|NCT01807234|OG000|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
11138756|NCT01807234|OG001|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
11138757|NCT01807234|OG002|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
11138758|NCT01807234|OG001|Outcome|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
11138759|NCT01807234|OG001|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
11138760|NCT01807234|EG000|Reported Event|Sprix/Placebo|"Sprix 31.5 mg single dose nasal spray and Placebo~SPRIX: Single dose of Sprix nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~The most common adverse events reported by participants treated with ketorolac NS were burning of nose, (mild in 25.5%, moderate in 19.6% and severe in 3.9%), unusual taste (mild in 2%, moderate in 5.9%, severe 2%), nasal discomfort (8%), burning of throat (6%), fatigue (4%), dizziness (4%), nausea (2%), rash (2%)."
10887418|NCT00500331|OG000|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
11138761|NCT01807234|EG001|Reported Event|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~For those treated with sumatriptan NS the most common adverse events were unusual taste (mild in 24.5%, moderate in 12.2%, severe 4.1%), burning of the nose (mild in 6.1%, moderate in 2%), nausea (8%), burning of the throat (6%), nasal discomfort (6%), dizziness (4%), fatigue (4%) and rash (2%)."
11138762|NCT01807234|EG002|Reported Event|SRIX Placebo/Sumatriptan Placebo|"single dose SPRIX placebo, single dose Sumatriptan placebo~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~The most common adverse event for placebo were unusual taste (mild in 4%, moderate in 2%), nausea (4%), rash (4%), fatigue (4%), burning of the nose (2%), dizziness (2%)."
11138763|NCT01807299|BG000|Baseline|Omega-3 Only|Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
11138764|NCT01807299|BG001|Baseline|Sedentary (Control)|"The sedentary group will be oriented not to make any type of physical training for three months.~Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day."
11138765|NCT01807299|BG002|Baseline|Placebo + Phsycal Training|"The omega 3 group will receive 2g per day of mineral oil during 90 days treatment~Physical Training"
11138766|NCT01807299|BG003|Baseline|Omega 3 + Phsycal Training|"The omega 3 group will receive 2g per day of fish oil during 90 days treatment~Physical Training"
11138767|NCT01807299|BG004|Baseline|Total|Total of all reporting groups
11138768|NCT01807299|FG000|Participant Flow|Omega-3|Take Omega-3 Only
11138769|NCT01807299|FG001|Participant Flow|Sedentary (Control)|The sedentary group will be oriented not to make any type of physical training for three months.
11138770|NCT01807299|FG002|Participant Flow|Placebo + Physical Training|"The omega 3 group will receive 2g per day of mineral oil during 90 days treatment~Physical Training"
11138771|NCT01807299|FG003|Participant Flow|Omega 3 + Physical Training|"The omega 3 group will receive 2g per day of fish oil during 90 days treatment~Physical Training"
11138772|NCT01807299|OG000|Outcome|Omega-3 Only|Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
11138773|NCT01807299|OG001|Outcome|Sedentary (Control)|The sedentary group will be oriented not to make any type of physical training for three months.
11138774|NCT01807299|OG002|Outcome|Placebo + Phsycal Training|"The omega 3 group will receive 2g per day of mineral oil during 90 days treatment~Physical Training"
11138775|NCT01807299|OG003|Outcome|Omega 3 + Phsycal Training|"The omega 3 group will receive 2g per day of fish oil during 90 days treatment~Physical Training"
11138776|NCT01807299|EG000|Reported Event|Omega-3 Only|Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
11138777|NCT01807299|EG001|Reported Event|Sedentary (Control)|The sedentary group will be oriented not to make any type of physical training for three months.
11138778|NCT01807299|EG002|Reported Event|Placebo + Phsycal Training|"The omega 3 group will receive 2g per day of mineral oil during 90 days treatment~Physical Training"
11138779|NCT01807299|EG003|Reported Event|Omega 3 + Phsycal Training|"The omega 3 group will receive 2g per day of fish oil during 90 days treatment~Physical Training"
10887419|NCT00500331|OG001|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11138780|NCT01807455|BG000|Baseline|Restylane Vital Lidocaine|Restylane Vital Lidocaine
11138781|NCT01807455|FG000|Participant Flow|Restylane Vital Lidocaine|Restylane Vital Lidocaine
11138782|NCT01807455|OG000|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
11138783|NCT01807455|EG000|Reported Event|Restylane Vital Lidocaine|Restylane Vital Lidocaine
11138784|NCT01807520|BG000|Baseline|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
11138785|NCT01807520|BG001|Baseline|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
11138786|NCT01807520|BG002|Baseline|Placebo|Participants who received placebo during treatment period 1
11138787|NCT01807520|BG003|Baseline|Total|Total of all reporting groups
11138788|NCT01807520|FG000|Participant Flow|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
11138789|NCT01807520|FG001|Participant Flow|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
11138790|NCT01807520|FG002|Participant Flow|Placebo|Participants who received placebo during treatment period 1
11138791|NCT01807520|FG003|Participant Flow|Placebo - AIN457 150 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
11138792|NCT01807520|FG004|Participant Flow|Placebo - AIN457 300 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
11138793|NCT01807520|FG005|Participant Flow|Any AIN457 150 mg|Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2
11009344|NCT01101178|EG001|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
11009345|NCT01101178|EG002|Reported Event|Screening|
11009346|NCT01101191|BG000|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
11009347|NCT01101191|FG000|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
11009348|NCT01101191|FG001|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
11009349|NCT01101191|OG000|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009350|NCT01101191|OG001|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009351|NCT01101191|EG000|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
11009352|NCT01101191|EG001|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
11009353|NCT01101191|EG002|Reported Event|Prerandomization|
11009354|NCT01101308|BG000|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
11009355|NCT01101308|FG000|Participant Flow|Reformulated OXY 10 mg (Totowa) (Test) First|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Totowa) (Test) in period 1 and reformulated OXY (Wilson) (Reference)in period 2.
11009356|NCT01101308|FG001|Participant Flow|Reformulated OXY 10 mg (Wilson) (Reference) First|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Wilson) (Reference) in period 1 and reformulated OXY (Totowa) (Test) in period 2.
11009357|NCT01101308|OG000|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009358|NCT01101308|OG001|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009359|NCT01101308|EG000|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009360|NCT01101308|EG001|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009361|NCT01101308|EG002|Reported Event|Prerandomization|
11009362|NCT01101321|BG000|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
11009363|NCT01101321|FG000|Participant Flow|Reformulated OXY (Totowa) (Test) First|Reformulated OXY 80-mg tablet (Totowa)(Test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Totowa) (Test) in period 1 and Reformulated OXY (Wilson) (Reference) in period 2.
11009364|NCT01101321|FG001|Participant Flow|Reformulated OXY (Wilson) (Reference) First|Reformulated OXY 80-mg tablet (Wilson) (Reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Wilson) (Reference) in period 1 and Reformulated OXY (Totowa) (Test) in period 2.
11009365|NCT01101321|OG000|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009366|NCT01101321|OG001|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009367|NCT01101321|EG000|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009368|NCT01101321|EG001|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
11009369|NCT01101334|BG000|Baseline|CS-7017 Plus Erlotinib|Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.
11009370|NCT01101334|BG001|Baseline|Erlotinib|Participants who received one 150 mg erlotinib tablet administered once daily.
11009371|NCT01101334|BG002|Baseline|Total|Total of all reporting groups
11009372|NCT01101334|FG000|Participant Flow|CS-7017 Plus Erlotinib|Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.
11009373|NCT01101334|FG001|Participant Flow|Erlotinib|Participants who received one 150 mg erlotinib tablet administered once daily.
11009374|NCT01101334|OG000|Outcome|CS-7017 Plus Erlotinib|Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.
11009375|NCT01101334|OG001|Outcome|Erlotinib|Participants who received one 150 mg erlotinib tablet administered once daily.
11138794|NCT01807520|FG006|Participant Flow|Any AIN457 300 mg|Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2
11138795|NCT01807520|OG000|Outcome|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
11138796|NCT01807520|OG001|Outcome|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
11138797|NCT01807520|OG002|Outcome|Placebo|Participants who received placebo during treatment period 1
11138798|NCT01807520|OG002|Outcome|Placebo - AIN457 150 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
11138799|NCT01807520|OG003|Outcome|Placebo - AIN457 300 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
11138800|NCT01807520|EG000|Reported Event|Any AIN457 150 mg|Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2
11138801|NCT01807520|EG001|Reported Event|Any AIN457 300 mg|Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2
11138802|NCT01807520|EG002|Reported Event|Placebo|Participants who received placebo during treatment period 1
11138803|NCT01807520|EG003|Reported Event|Any AIN457 Dose|Participants who received AIN457 150 mg or AIN457 300 mg
11138804|NCT01807585|BG000|Baseline|Roll-In (VenaSeal SCS)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization). These subjects underwent the same preoperative and postoperative assessments (with the same schedule) as patients who underwent randomization.
11138805|NCT01807585|BG001|Baseline|VenaSeal SCS (Randomized Phase)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138806|NCT01807585|BG002|Baseline|RFA (Randomized Phase)|Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138807|NCT01807585|BG003|Baseline|Total|Total of all reporting groups
11138808|NCT01807585|FG000|Participant Flow|Roll-In (VenaSeal SCS)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization). These subjects underwent the same preoperative and postoperative assessments (with the same schedule) as patients who underwent randomization.
11138809|NCT01807585|FG001|Participant Flow|VenaSeal SCS (Randomized Phase)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138810|NCT01807585|FG002|Participant Flow|RFA (Randomized Phase)|Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138811|NCT01807585|OG000|Outcome|VenaSeal SCS (Randomized Phase)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA
11138812|NCT01807585|OG001|Outcome|RFA (Randomized Phase)|Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138813|NCT01807585|OG000|Outcome|Roll-In (VenaSeal SCS)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization). These subjects underwent the same preoperative and postoperative assessments (with the same schedule) as patients who underwent randomization.
11138814|NCT01807585|OG001|Outcome|VenaSeal SCS (Randomized Phase)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138815|NCT01807585|OG002|Outcome|RFA (Randomized Phase)|Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138816|NCT01807585|OG001|Outcome|VenaSeal SCS (Randomized Phase)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA
11138817|NCT01807585|EG000|Reported Event|Roll-In (VenaSeal SCS)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization). These subjects underwent the same preoperative and postoperative assessments (with the same schedule) as patients who underwent randomization.
11138818|NCT01807585|EG001|Reported Event|VenaSeal SCS (Randomized Phase)|Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138819|NCT01807585|EG002|Reported Event|RFA (Randomized Phase)|Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
11138820|NCT01807598|BG000|Baseline|Brentuximab Vedotin|Subjects receive a 30-minute IV infusion of brentuximab vedotin once every 21 days for 8 courses, in the absence of disease progression or unacceptable toxicity.
11138821|NCT01807598|FG000|Participant Flow|Brentuximab Vedotin|Subjects receive a 30-minute IV infusion of brentuximab vedotin once every 21 days for 8 courses, in the absence of disease progression or unacceptable toxicity.
11138822|NCT01807598|OG000|Outcome|Brentuximab Vedotin|Subjects receive a 30-minute IV infusion of brentuximab vedotin once every 21 days for 8 courses, in the absence of disease progression or unacceptable toxicity.
11138823|NCT01807598|EG000|Reported Event|Brentuximab Vedotin|Subjects receive a 30-minute IV infusion of brentuximab vedotin once every 21 days for 8 courses, in the absence of disease progression or unacceptable toxicity.
11138824|NCT01807624|BG000|Baseline|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
10879715|NCT00459355|OG000|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
10879716|NCT00459355|OG001|Outcome|Checklist|non-intervention group received conventional home safety checklist
11138825|NCT01807624|FG000|Participant Flow|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
11138826|NCT01807624|OG000|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
11138827|NCT01807624|EG000|Reported Event|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
11138828|NCT01807637|BG000|Baseline|Transcranial Direct Current Stim|"tDCS will be applied using a Soterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere [established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment]. The cathodal electrode will be placed over the contralateral motor cortex.~transcranial direct current stim (tDCS): During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down). During sham stimulation the stimulator is turned off."
11138829|NCT01807637|BG001|Baseline|Sham tDCS|"Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).~transcranial direct current stim (tDCS): During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down). During sham stimulation the stimulator is turned off."
11138830|NCT01807637|BG002|Baseline|Total|Total of all reporting groups
11138831|NCT01807637|FG000|Participant Flow|Transcranial Direct Current Stim|tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere [established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
11138832|NCT01807637|FG001|Participant Flow|Sham tDCS|Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
11138833|NCT01807637|OG000|Outcome|Active tDCS: Week 5 - Baseline.|tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere [established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
11138834|NCT01807637|OG001|Outcome|Active tDCS: Week 8 - Baseline|tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere [established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
11138835|NCT01807637|OG002|Outcome|Sham tDCS; Week 5 - Baseline.|Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
11138836|NCT01807637|OG003|Outcome|Sham tDCS: Week 8 - Baseline.|Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
11138837|NCT01807637|EG000|Reported Event|Transcranial Direct Current Stim|tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere [established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
11138838|NCT01807637|EG001|Reported Event|Sham tDCS|Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
11138839|NCT01807650|BG000|Baseline|Entire Study Population|Intra-individual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing only. Non-adhesive wound dressings, specifically soft silicone faced polyurethane foam dressings (e.g., Mepilex®), represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of 1 mm (0.04 inches) and wound dressings were changed at least every 3 to 4 days. Study treatment continued until both wound halves were closed (at least 95% epithelialised) or ended at Day 28.
11138840|NCT01807650|FG000|Participant Flow|Entire Study Population|A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing. The other wound half was covered with a non-adhesive wound dressing only as control (intra-individual comparison)
11138841|NCT01807650|OG000|Outcome|Entire Study Population|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
11138842|NCT01807650|OG000|Outcome|Oleogel-S10 and Non-adhesive Wound Dressing|A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing.
11138843|NCT01807650|OG001|Outcome|Non-adhesive Wound Dressing Only|A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
11138844|NCT01807650|OG000|Outcome|Investigator Asssessment Day 7|Efficacy as assessed by investigator at Day 7
11138845|NCT01807650|OG001|Outcome|Investigator Assessment Day 14|Efficacy as assessed by investigator at Day 14
11138846|NCT01807650|OG002|Outcome|Investigator Assessment Day 21|Efficacy as assessed by investigator at Day 21
11138847|NCT01807650|OG003|Outcome|Investigator Assessment Day 28|Efficacy as assessed by investigator at Day 28
11138848|NCT01807650|OG004|Outcome|Investigator Assessment End of Treatment|Efficacy as assessed by investigator at End of Treatment (EoT)
11138849|NCT01807650|OG005|Outcome|Participant Assessment Day 7|Efficacy as assessed by participant at Day 7
11138850|NCT01807650|OG006|Outcome|Participant Assessment Day 14|Efficacy as assessed by participant at Day 14
11138851|NCT01807650|OG007|Outcome|Participant Assessment Day 21|Efficacy as assessed by participant at Day 21
11138852|NCT01807650|OG008|Outcome|Participant Assessment Day 28|Efficacy as assessed by participant at Day 28
11138853|NCT01807650|OG009|Outcome|Participant Assessment EoT|Efficacy as assessed by participant at EoT
11138854|NCT01807650|OG000|Outcome|Texture at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to texture at 3 months follow-up
11138855|NCT01807650|OG001|Outcome|Hair Growth at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to hair growth at 3 months follow-up
11138856|NCT01807650|OG002|Outcome|Pigmentation at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to pigmentation at 3 months follow-up
11138857|NCT01807650|OG003|Outcome|Redness at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to redness at 3 months follow-up
11138858|NCT01807650|OG004|Outcome|Texture at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to texture at 12 months follow-up
11138859|NCT01807650|OG005|Outcome|Hair Growth at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to hair growth at 12 months follow-up
11138860|NCT01807650|OG006|Outcome|Pigmentation at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to pigmentation at 12 months follow-up
11138861|NCT01807650|OG007|Outcome|Redness at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to redness at 12 months follow-up
11138862|NCT01807650|OG000|Outcome|Investigator Asssessment Day 7|Tolerability as assessed by investigator at Day 7
11138863|NCT01807650|OG001|Outcome|Investigator Assessment Day 14|Tolerability as assessed by investigator at Day 14
11138864|NCT01807650|OG002|Outcome|Investigator Assessment Day 21|Tolerability as assessed by investigator at Day 21
10879717|NCT00459355|OG001|Outcome|Checklist|Conventional home safety checklist
10879718|NCT00459355|OG001|Outcome|Conventional Safety Checklist|Comparison group received a conventional home safety checklist
10887420|NCT00500331|OG002|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11138865|NCT01807650|OG003|Outcome|Investigator Assessment Day 28|Tolerability as assessed by investigator at Day 28
11138866|NCT01807650|OG004|Outcome|Investigator Assessment End of Treatment|Tolerability as assessed by investigator at End of Treatment (EoT)
11138867|NCT01807650|OG005|Outcome|Participant Assessment Day 7|Tolerability as assessed by participant at Day 7
11138868|NCT01807650|OG006|Outcome|Participant Assessment Day 14|Tolerability as assessed by participant at Day 14
11138869|NCT01807650|OG007|Outcome|Participant Assessment Day 21|Tolerability as assessed by participant at Day 21
11138870|NCT01807650|OG008|Outcome|Participant Assessment Day 28|Tolerability as assessed by participant at Day 28
11138871|NCT01807650|OG009|Outcome|Participant Assessment EoT|Tolerability as assessed by participant at EoT
11138872|NCT01807650|OG000|Outcome|Day 0 (Pre-dose)|Plasma samples collected at the day of STSG surgery prior to first treatment with study medication
11138873|NCT01807650|OG001|Outcome|Treatment Period|Plasma samples collected at Day 7, Day 14, Day 21 or at end of treatment (day of wound closure or Day 28)
11138874|NCT01807650|OG000|Outcome|Entire Study Population|All participants who were randomized and treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only.
11138875|NCT01807650|EG000|Reported Event|Entire Study Population - Systemic Adverse Events (AE)|All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. AEs not localized to any wound application site by the investigator are reported in this arm.
11138876|NCT01807650|EG001|Reported Event|Oleogel-S10 Localized Adverse Event (AE)|All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the Oleogel-S10 wound half are reported in this arm.
11138877|NCT01807650|EG002|Reported Event|Non-adhesive Wound Dressing Localized AE|All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the wound half treated with non-adhesive wound dressing only are reported in this arm.
11138878|NCT01807650|EG003|Reported Event|Localized AE Both Wound Halves|All participants treated with Oleogel-S10 and non-adhesive wound dressing and non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred at both the Oleogel-S10 wound half and the non-adhesive wound dressing only half in one participant are reported in this arm.
11138879|NCT01807650|EG004|Reported Event|Entire Study Population -Systemic and Localized AEs|All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Local and systemic AEs are reported in this arm.
11138880|NCT01807871|BG000|Baseline|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
11138881|NCT01807871|BG001|Baseline|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
11138882|NCT01807871|BG002|Baseline|Total|Total of all reporting groups
11138883|NCT01807871|FG000|Participant Flow|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
11138884|NCT01807871|FG001|Participant Flow|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
11138885|NCT01807871|OG000|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
11138886|NCT01807871|OG001|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
11138887|NCT01807871|EG000|Reported Event|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
11138888|NCT01807871|EG001|Reported Event|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
11138889|NCT01807923|BG000|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
11138890|NCT01807923|BG001|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138891|NCT01807923|BG002|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138892|NCT01807923|BG003|Baseline|Total|Total of all reporting groups
11138893|NCT01807923|FG000|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
11138894|NCT01807923|FG001|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11009376|NCT01101334|EG000|Reported Event|CS-7017 Plus Erlotinib|Participants who received two 0.25 mg CS-7017 tablets administered twice daily and one 150 mg erlotinib tablet administered once daily.
11138895|NCT01807923|FG002|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138896|NCT01807923|OG000|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
11138897|NCT01807923|OG001|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138898|NCT01807923|OG002|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138899|NCT01807923|OG000|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138900|NCT01807923|OG001|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138901|NCT01807923|EG000|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
11138902|NCT01807923|EG001|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138903|NCT01807923|EG002|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138904|NCT01807949|BG000|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
11138905|NCT01807949|BG001|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138906|NCT01807949|BG002|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138907|NCT01807949|BG003|Baseline|Total|Total of all reporting groups
11138908|NCT01807949|FG000|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
11138909|NCT01807949|FG001|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138910|NCT01807949|FG002|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138911|NCT01807949|OG000|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
11138912|NCT01807949|OG001|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138913|NCT01807949|OG002|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138914|NCT01807949|OG000|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138915|NCT01807949|OG001|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138916|NCT01807949|EG000|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
11138917|NCT01807949|EG001|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
11138918|NCT01807949|EG002|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
11138919|NCT01808066|BG000|Baseline|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.~Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
11138920|NCT01808066|FG000|Participant Flow|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
11138921|NCT01808066|OG000|Outcome|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.~Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
11138922|NCT01808066|OG000|Outcome|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
11138923|NCT01808066|EG000|Reported Event|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
11138924|NCT01808092|BG000|Baseline|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
11138925|NCT01808092|BG001|Baseline|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
11138926|NCT01808092|BG002|Baseline|Total|Total of all reporting groups
11138927|NCT01808092|FG000|Participant Flow|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
11138928|NCT01808092|FG001|Participant Flow|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
11138929|NCT01808092|OG000|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
11138930|NCT01808092|OG001|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
11138931|NCT01808092|EG000|Reported Event|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
11138932|NCT01808092|EG001|Reported Event|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
11138933|NCT01808118|BG000|Baseline|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
11138934|NCT01808118|FG000|Participant Flow|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
11138935|NCT01808118|FG001|Participant Flow|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
11138936|NCT01808118|FG002|Participant Flow|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
11138937|NCT01808118|OG000|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
11138938|NCT01808118|OG001|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
11138939|NCT01808118|OG000|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
10879719|NCT00459355|EG000|Reported Event|Home Safety Toolkit:Care Recipients|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
11009377|NCT01101334|EG001|Reported Event|Erlotinib|Participants who received one 150 mg erlotinib tablet administered once daily.
11009378|NCT01101477|BG000|Baseline|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11138940|NCT01808118|OG001|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
11138941|NCT01808118|OG001|Outcome|Double-blind Adalimumab (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
11138942|NCT01808118|OG000|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
11138943|NCT01808118|OG001|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
11138944|NCT01808118|OG002|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
11138945|NCT01808118|EG000|Reported Event|Open-label (OL) Adalimumab (Period 1), Full Analysis Set|40 mg every other week (eow), Weeks 0-28. The Full Analysis Set included all participants who enrolled in the open-label period (Period 1) and received at least 1 dose of adalimumab.
11138946|NCT01808118|EG001|Reported Event|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
11138947|NCT01808118|EG002|Reported Event|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
11138948|NCT01808118|EG003|Reported Event|Any Adalimumab Population|The Any Adalimumab Population consisted of all participants who received at least 1 dose of adalimumab any time during the study (including the open-label period, double-blind period and rescue period).
11138949|NCT01808144|BG000|Baseline|Lesinurad 400 mg + Febuxostat 80 mg|
11138950|NCT01808144|BG001|Baseline|Lesinurad 200 mg + Febuxostat 80 mg|
11138951|NCT01808144|BG002|Baseline|Total|Total of all reporting groups
11138952|NCT01808144|FG000|Participant Flow|Lesinurad 200 mg + Febuxostat 80 mg|
11138953|NCT01808144|FG001|Participant Flow|Lesinurad 400 mg + Febuxostat 80 mg|
11138954|NCT01808144|OG000|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|
11138955|NCT01808144|OG001|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|
11138956|NCT01808144|EG000|Reported Event|Lesinurad 200 mg + Febuxostat 80 mg|
11138957|NCT01808144|EG001|Reported Event|Lesinurad 400 mg + Febuxostat 80 mg|
11138958|NCT01808196|BG000|Baseline|Losartan|"Participants with eosinophilic esophagitis receive the Losartan daily~Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg."
11138959|NCT01808196|FG000|Participant Flow|Losartan|"Participants with eosinophilic esophagitis receive the Losartan daily~Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg."
11138960|NCT01808196|OG000|Outcome|Losartan|"Participants with eosinophilic esophagitis receive Losartan daily~Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg."
11138961|NCT01808196|EG000|Reported Event|Losartan|"Participants with eosinophilic esophagitis receive Losartan daily~Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg."
11138962|NCT01808209|BG000|Baseline|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
11138963|NCT01808209|BG001|Baseline|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
11138964|NCT01808209|BG002|Baseline|Total|Total of all reporting groups
11138965|NCT01808209|FG000|Participant Flow|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
11138966|NCT01808209|FG001|Participant Flow|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
11138967|NCT01808209|OG000|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
11138968|NCT01808209|OG000|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
11138969|NCT01808209|OG001|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
11138970|NCT01808209|OG000|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
11138971|NCT01808209|OG000|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
11138972|NCT01808209|OG001|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
11138973|NCT01808209|EG000|Reported Event|Stenfilcon A|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
11138974|NCT01808209|EG001|Reported Event|Filcon II 3|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
10879720|NCT00459355|EG001|Reported Event|Checklist:Care Recipients|Control group receives conventional list of home safety recommendations
11138975|NCT01808222|BG000|Baseline|FACBC|Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence.
11138976|NCT01808222|FG000|Participant Flow|FACBC|Participants receiving a bolus of anti-[18F]FACBC injected with positron emission tomography (PET)-computerized tomography (CT) (PET-CT) and a multiparametric MRI (mpMR) for detection of cancer recurrence.
11138977|NCT01808222|OG000|Outcome|FACBC|Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence.
11138978|NCT01808222|EG000|Reported Event|FACBC|Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence.
11138979|NCT01808248|BG000|Baseline|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 hepatitis C virus (HCV) infection.
11138980|NCT01808248|BG001|Baseline|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
11138981|NCT01808248|BG002|Baseline|Total|Total of all reporting groups
11138982|NCT01808248|FG000|Participant Flow|SOF+PEG+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + peginterferon alfa 2a (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
11138983|NCT01808248|OG000|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
11138984|NCT01808248|OG001|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
11138985|NCT01808248|OG000|Outcome|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
11138986|NCT01808248|EG000|Reported Event|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
11138987|NCT01808313|BG000|Baseline|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
11138988|NCT01808313|FG000|Participant Flow|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
11138989|NCT01808313|OG000|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
11138990|NCT01808313|EG000|Reported Event|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
11138991|NCT01808326|BG000|Baseline|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
11138992|NCT01808326|FG000|Participant Flow|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
11138993|NCT01808326|OG000|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
11138994|NCT01808326|EG000|Reported Event|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
11138995|NCT01808339|BG000|Baseline|FF 100 µg AM/FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in either of the six sequences: ABC , ACB, BAC, BCA, CAB, or CBA. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI), during treatment B: participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI during treatment C: participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11138996|NCT01808339|FG000|Participant Flow|FF 100 µg AM /FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in sequence ABC. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI). During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11138997|NCT01808339|FG001|Participant Flow|FF 100 µg AM/Placebo/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence ACB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11138998|NCT01808339|FG002|Participant Flow|FF 100 µg PM /FF 100 µg AM/Placebo|Participants received 3 treatments (A, B, and C) in sequence BAC. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11138999|NCT01808339|FG003|Participant Flow|FF 100 µg PM /Placebo/FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence BCA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11139000|NCT01808339|FG004|Participant Flow|Placebo/FF 100 µg AM/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence CAB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11149755|NCT01872910|EG004|Reported Event|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
11149756|NCT01872910|EG005|Reported Event|Pre-Part B - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement.
11139001|NCT01808339|FG005|Participant Flow|Placebo/FF 100 µg PM /FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence CBA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11139002|NCT01808339|OG000|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11139003|NCT01808339|OG001|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11139004|NCT01808339|OG002|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11139005|NCT01808339|EG000|Reported Event|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11139006|NCT01808339|EG001|Reported Event|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11139007|NCT01808339|EG002|Reported Event|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11139008|NCT01808508|BG000|Baseline|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
11139009|NCT01808508|BG001|Baseline|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
11139010|NCT01808508|BG002|Baseline|Group 3 - No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group
11139011|NCT01808508|BG003|Baseline|Total|Total of all reporting groups
11139012|NCT01808508|FG000|Participant Flow|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
11139013|NCT01808508|FG001|Participant Flow|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
11139014|NCT01808508|FG002|Participant Flow|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
11139015|NCT01808508|OG000|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
11139016|NCT01808508|OG001|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
11139017|NCT01808508|OG002|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
11139018|NCT01808508|EG000|Reported Event|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
11139019|NCT01808508|EG001|Reported Event|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
11139020|NCT01808508|EG002|Reported Event|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
11139021|NCT01808534|BG000|Baseline|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11149757|NCT01873287|BG000|Baseline|Derivation Cohort|
10887421|NCT00500331|OG003|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11139022|NCT01808534|FG000|Participant Flow|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11139023|NCT01808534|OG000|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11139024|NCT01808534|EG000|Reported Event|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11139025|NCT01808547|BG000|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
11139026|NCT01808547|BG001|Baseline|Vehicle|DuraSite vehicle dosed BID
11139027|NCT01808547|BG002|Baseline|Total|Total of all reporting groups
11139028|NCT01808547|FG000|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
11139029|NCT01808547|FG001|Participant Flow|Vehicle|DuraSite vehicle dosed BID
11139030|NCT01808547|OG000|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
11139031|NCT01808547|OG001|Outcome|Vehicle|DuraSite vehicle dosed BID
11139032|NCT01808547|EG000|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
11139033|NCT01808547|EG001|Reported Event|Vehicle|DuraSite vehicle dosed BID
11139034|NCT01808560|BG000|Baseline|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11139035|NCT01808560|BG001|Baseline|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
11139036|NCT01808560|BG002|Baseline|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11139037|NCT01808560|BG003|Baseline|Total|Total of all reporting groups
11139038|NCT01808560|FG000|Participant Flow|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11139039|NCT01808560|FG001|Participant Flow|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
11139040|NCT01808560|FG002|Participant Flow|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11139041|NCT01808560|OG000|Outcome|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11139042|NCT01808560|OG001|Outcome|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
11139043|NCT01808560|OG002|Outcome|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11139044|NCT01808560|EG000|Reported Event|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11139045|NCT01808560|EG001|Reported Event|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
11139046|NCT01808560|EG002|Reported Event|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11139047|NCT01808573|BG000|Baseline|Neratinib Plus Capecitabine|neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
11139048|NCT01808573|BG001|Baseline|Lapatinib Plus Capecitabine|lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
11139049|NCT01808573|BG002|Baseline|Total|Total of all reporting groups
11149758|NCT01873287|BG001|Baseline|Validation Cohort|
11149759|NCT01873287|BG002|Baseline|Total|Total of all reporting groups
11139050|NCT01808573|FG000|Participant Flow|Neratinib Plus Capecitabine|neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
11139051|NCT01808573|FG001|Participant Flow|Lapatinib Plus Capecitabine|lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
11139052|NCT01808573|OG000|Outcome|Neratinib Plus Capecitabine|neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
11139053|NCT01808573|OG001|Outcome|Lapatinib Plus Capecitabine|lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
11139054|NCT01808573|EG000|Reported Event|Neratinib Plus Capecitabine|neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
11139055|NCT01808573|EG001|Reported Event|Lapatinib Plus Capecitabine|lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
11139056|NCT01808612|BG000|Baseline|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
11139057|NCT01808612|BG001|Baseline|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
10879721|NCT00459355|EG002|Reported Event|Home Safety Toolkit:Caregivers|Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
11139058|NCT01808612|BG002|Baseline|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
11139059|NCT01808612|BG003|Baseline|Total|Total of all reporting groups
11139060|NCT01808612|FG000|Participant Flow|20 mg Fluoxetine|"Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
11139061|NCT01808612|FG001|Participant Flow|40 mg Fluoxetine|"Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
11139062|NCT01808612|FG002|Participant Flow|Placebo|"Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
11139063|NCT01808612|OG000|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
11139064|NCT01808612|OG001|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
11139065|NCT01808612|OG002|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
11139066|NCT01808612|EG000|Reported Event|Placebo (Treatment Period)|Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period
11139067|NCT01808612|EG001|Reported Event|20 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
11139068|NCT01808612|EG002|Reported Event|40 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
11139069|NCT01808612|EG003|Reported Event|Placebo (Discontinuation From Placebo)|AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
11139070|NCT01808612|EG004|Reported Event|Placebo (Discontinuation From 20 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
11139071|NCT01808612|EG005|Reported Event|Placebo (Discontinuation From 40 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
11139072|NCT01808651|BG000|Baseline|PLA/FLX (Placebo/Fluoxetine)|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
11139073|NCT01808651|BG001|Baseline|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
11139074|NCT01808651|BG002|Baseline|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
11139075|NCT01808651|BG003|Baseline|Total|Total of all reporting groups
11139076|NCT01808651|FG000|Participant Flow|PLA/FLX|"Period 1: Participants (Pts) randomized to placebo in Study B1Y-JE-HCLV transitioned to fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation (DC'd) of fluoxetine."
11139077|NCT01808651|FG001|Participant Flow|FLX20/FLX|"Period 1: Participants randomized to fluoxetine 20 mg /day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation of fluoxetine."
11139078|NCT01808651|FG002|Participant Flow|FLX40/FLX|"Period 1: Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation of fluoxetine."
11139079|NCT01808651|OG000|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
10879722|NCT00459355|EG003|Reported Event|Checklist:Caregivers|Control group receives conventional list of home safety recommendations
11139080|NCT01808651|OG001|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
11139081|NCT01808651|OG002|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
11139082|NCT01808651|EG000|Reported Event|Study Period 1 PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
11139083|NCT01808651|EG001|Reported Event|Study Period 1 FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
11139084|NCT01808651|EG002|Reported Event|Study Period 1 FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
11139085|NCT01808651|EG003|Reported Event|Study Period 2 Discontinued From PLA/FLX|Participants in the PLA/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2,
11139086|NCT01808651|EG004|Reported Event|Study Period 2 Discontinued From FLX20/FLX|Participants in the FLX20/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
11139087|NCT01808651|EG005|Reported Event|Study Period 2 Discontinued From FLX40/FLX|Participants in the FLX40/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
11139088|NCT01808690|BG000|Baseline|Metformin|"Metformin will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to placebo.~Metformin"
11139089|NCT01808690|BG001|Baseline|Placebo|"Placebo will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to metformin.~Placebo"
11139090|NCT01808690|BG002|Baseline|Total|Total of all reporting groups
11139091|NCT01808690|FG000|Participant Flow|Metformin|"Metformin will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to placebo.~Metformin"
11139092|NCT01808690|FG001|Participant Flow|Placebo|"Placebo will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to metformin.~Placebo"
11139093|NCT01808690|OG000|Outcome|Metformin|"Metformin will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to placebo.~Metformin"
11139094|NCT01808690|OG001|Outcome|Placebo|"Placebo will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to metformin.~Placebo"
11139095|NCT01808690|EG000|Reported Event|Metformin|"Metformin will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to placebo.~Metformin"
11139096|NCT01808690|EG001|Reported Event|Placebo|"Placebo will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to metformin.~Placebo"
11139097|NCT01808755|BG000|Baseline|All Study Participamts|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
11139098|NCT01808755|FG000|Participant Flow|D Mannose First, Then Trimethoprim/Sulfamethoxazole|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days
11139099|NCT01808755|FG001|Participant Flow|Trimethoprim/Sulfamethoxazole First, Then D Mannose|Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
11139100|NCT01808755|OG000|Outcome|D Mannose First, Then Trimethoprim /Sulfamethoxazole|1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
11139101|NCT01808755|OG001|Outcome|Trimethoprim /Sulfamethoxazole First, Then D Mannose|trimethoprim/sulfametossazole 160/800 mg for 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks
11139102|NCT01808755|EG000|Reported Event|D Mannose Versus Antibiotic|"1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks~D Mannose : D Mannose versus oral antibiotic~Antibiotic : length of treatment: 5-7 days"
11139103|NCT01808963|BG000|Baseline|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
11139104|NCT01808963|FG000|Participant Flow|Study Group|Patients undergoing elective surgery requiring endotracheal intubation for anesthesia.
11139105|NCT01808963|OG000|Outcome|Study Group|Joules per minute
11139106|NCT01808963|EG000|Reported Event|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
11139107|NCT01809054|BG000|Baseline|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
11139108|NCT01809054|BG001|Baseline|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
11139109|NCT01809054|BG002|Baseline|Total|Total of all reporting groups
11139110|NCT01809054|FG000|Participant Flow|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
11139111|NCT01809054|FG001|Participant Flow|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
11139112|NCT01809054|OG000|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
11139113|NCT01809054|OG001|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
11139114|NCT01809054|EG000|Reported Event|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
11139115|NCT01809054|EG001|Reported Event|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
11139116|NCT01809106|BG000|Baseline|Morphine|Morphine: 60 mg /24 ore
11139117|NCT01809106|BG001|Baseline|Oxycodone|Oxycodone: 40 mg /24 ore
11139118|NCT01809106|BG002|Baseline|Buprenorphine|Buprenorphine: 35 microg/h
11139119|NCT01809106|BG003|Baseline|Fentanyl|Fentanyl: 25 microg/h
11139120|NCT01809106|BG004|Baseline|Total|Total of all reporting groups
11139121|NCT01809106|FG000|Participant Flow|Morphine|Morphine: 60 mg /24 ore
11139122|NCT01809106|FG001|Participant Flow|Oxycodone|Oxycodone: 40 mg /24 ore
11139123|NCT01809106|FG002|Participant Flow|Buprenorphine|Buprenorphine: 35 microg/h
11139124|NCT01809106|FG003|Participant Flow|Fentanyl|Fentanyl: 25 microg/h
11139125|NCT01809106|OG000|Outcome|Morphine|Morphine: 60 mg /24 ore
11139126|NCT01809106|OG001|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
11139127|NCT01809106|OG002|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
11139128|NCT01809106|OG003|Outcome|Fentanyl|Fentanyl: 25 microg/h
11139129|NCT01809106|EG000|Reported Event|Morphine|Morphine: 60 mg /24 ore
11139130|NCT01809106|EG001|Reported Event|Oxycodone|Oxycodone: 40 mg /24 ore
11139131|NCT01809106|EG002|Reported Event|Buprenorphine|Buprenorphine: 35 microg/h
11139132|NCT01809106|EG003|Reported Event|Fentanyl|Fentanyl: 25 microg/h
11139133|NCT01809132|BG000|Baseline|Anakinra & Pentoxifylline & Zinc Sulfate|"anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days~Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection.~Pentoxifylline: Pentoxifylline, generic~Zinc Sulfate: Zinc Sulfate, nutritional supplement"
11139134|NCT01809132|BG001|Baseline|Methylprednisolone|"methylprednisolone 32 mg orally daily for 28 days~Methylprednisolone: Methylprednisolone, corticosteroid"
11139135|NCT01809132|BG002|Baseline|Observational|Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
11139136|NCT01809132|BG003|Baseline|Total|Total of all reporting groups
11139137|NCT01809132|FG000|Participant Flow|Anakinra & Pentoxifylline & Zinc Sulfate|"anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days~Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection.~Pentoxifylline: Pentoxifylline, generic~Zinc Sulfate: Zinc Sulfate, nutritional supplement"
11139138|NCT01809132|FG001|Participant Flow|Methylprednisolone|"methylprednisolone 32 mg orally daily for 28 days~Methylprednisolone: Methylprednisolone, corticosteroid"
11139139|NCT01809132|FG002|Participant Flow|Observational|Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
11139140|NCT01809132|OG000|Outcome|Anakinra & Pentoxifylline & Zinc Sulfate|"anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days~Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection.~Pentoxifylline: Pentoxifylline, generic~Zinc Sulfate: Zinc Sulfate, nutritional supplement"
11139141|NCT01809132|OG001|Outcome|Methylprednisolone|"methylprednisolone 32 mg orally daily for 28 days~Methylprednisolone: Methylprednisolone, corticosteroid"
11139142|NCT01809132|OG002|Outcome|Observational|Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
11139143|NCT01809132|EG000|Reported Event|Anakinra & Pentoxifylline & Zinc Sulfate|"anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days~Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection.~Pentoxifylline: Pentoxifylline, generic~Zinc Sulfate: Zinc Sulfate, nutritional supplement"
11139144|NCT01809132|EG001|Reported Event|Methylprednisolone|"methylprednisolone 32 mg orally daily for 28 days~Methylprednisolone: Methylprednisolone, corticosteroid"
11139145|NCT01809132|EG002|Reported Event|Observational|Individuals who choose not to participate in the interventional arm of the trial will receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
11139146|NCT01809197|BG000|Baseline|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
11139147|NCT01809197|BG001|Baseline|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
11139148|NCT01809197|BG002|Baseline|Total|Total of all reporting groups
11139149|NCT01809197|FG000|Participant Flow|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
11139150|NCT01809197|FG001|Participant Flow|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
11139151|NCT01809197|OG000|Outcome|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
11139152|NCT01809197|OG001|Outcome|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
11139153|NCT01809197|EG000|Reported Event|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
11139154|NCT01809197|EG001|Reported Event|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
11139155|NCT01809210|BG000|Baseline|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
11139156|NCT01809210|BG001|Baseline|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
11139157|NCT01809210|BG002|Baseline|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
11139158|NCT01809210|BG003|Baseline|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139159|NCT01809210|BG004|Baseline|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139160|NCT01809210|BG005|Baseline|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
11139161|NCT01809210|BG006|Baseline|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139162|NCT01809210|BG007|Baseline|Total|Total of all reporting groups
11139163|NCT01809210|FG000|Participant Flow|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
11139164|NCT01809210|FG001|Participant Flow|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
11139165|NCT01809210|FG002|Participant Flow|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
11139166|NCT01809210|FG003|Participant Flow|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139167|NCT01809210|FG004|Participant Flow|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139168|NCT01809210|FG005|Participant Flow|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
11139169|NCT01809210|FG006|Participant Flow|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139170|NCT01809210|OG000|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
11139171|NCT01809210|OG001|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
11139172|NCT01809210|OG002|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
11139173|NCT01809210|OG003|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139174|NCT01809210|OG004|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139175|NCT01809210|OG005|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
11139176|NCT01809210|OG006|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139177|NCT01809210|EG000|Reported Event|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
11139178|NCT01809210|EG001|Reported Event|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
11139179|NCT01809210|EG002|Reported Event|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
11139180|NCT01809210|EG003|Reported Event|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139181|NCT01809210|EG004|Reported Event|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
10887422|NCT00500331|OG004|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11139182|NCT01809210|EG005|Reported Event|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
11139183|NCT01809210|EG006|Reported Event|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
11139184|NCT01809262|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a double-blind, 5-period crossover trial. Each of the 36 patients received placebo and 4 single doses of Olodaterol (Olo) (2 microgram (mcg), 5 mcg, 10 mcg, 20mcg) separated by a wash-out period of at least 14 days.
11139185|NCT01809262|FG000|Participant Flow|Placebo / Olo 2mcg / Olo 20mcg / Olo 5mcg / Olo 10mcg|Patients were administered matching Placebo in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139186|NCT01809262|FG001|Participant Flow|Placebo / Olo 20mcg / Olo 2mcg / Olo 10mcg / Olo 5mcg|Patients were administered matching Placebo in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139187|NCT01809262|FG002|Participant Flow|Olo 2mcg / Olo 5mcg / Placebo / Olo 10mcg / Olo 20mcg|Patients were administered Olodaterol 2 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
10887423|NCT00500331|OG005|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11139188|NCT01809262|FG003|Participant Flow|Olo 2mcg / Placebo / Olo 5mcg / Olo 20mcg / Olo 10mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139189|NCT01809262|FG004|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139190|NCT01809262|FG005|Participant Flow|Olo 5mcg / Olo 10mcg / Olo 2mcg / Olo 20mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139191|NCT01809262|FG006|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139192|NCT01809262|FG007|Participant Flow|Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139193|NCT01809262|FG008|Participant Flow|Olo 20mcg / Placebo / Olo 10mcg / Olo 2mcg / Olo 5mcg|Patients were administered Olodaterol 20 mcg qd in the first period, matching Placebo in the second period, Olodaterol 10 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139194|NCT01809262|FG009|Participant Flow|Olo 20mcg / Olo 10mcg / Placebo / Olo 5mcg / Olo 2mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, matching Placebo in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
11139195|NCT01809262|OG000|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
11139196|NCT01809262|OG001|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
11139197|NCT01809262|OG002|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
11139198|NCT01809262|OG003|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
11139199|NCT01809262|OG004|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
11139200|NCT01809262|EG000|Reported Event|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
11139201|NCT01809262|EG001|Reported Event|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
11139202|NCT01809262|EG002|Reported Event|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
11139203|NCT01809262|EG003|Reported Event|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
11139204|NCT01809262|EG004|Reported Event|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
11139205|NCT01809314|BG000|Baseline|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
11139206|NCT01809314|FG000|Participant Flow|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
11139207|NCT01809314|OG000|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
11139208|NCT01809314|EG000|Reported Event|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
11139209|NCT01809327|BG000|Baseline|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
11139210|NCT01809327|BG001|Baseline|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
11139211|NCT01809327|BG002|Baseline|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
11139212|NCT01809327|BG003|Baseline|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
11139213|NCT01809327|BG004|Baseline|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
11139214|NCT01809327|BG005|Baseline|Total|Total of all reporting groups
11139215|NCT01809327|FG000|Participant Flow|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
11139216|NCT01809327|FG001|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
11139217|NCT01809327|FG002|Participant Flow|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
11139218|NCT01809327|FG003|Participant Flow|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
10887424|NCT00500331|OG006|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
11224539|NCT02360605|EG001|Reported Event|Prevention Coordinator Arm|"Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.~prevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.~Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1."
11224540|NCT02360631|BG000|Baseline|Chantix (Varenicline)|"Participants will receive 1mg pills to take twice a day for 12 weeks.~Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking."
11224541|NCT02360631|BG001|Baseline|Placebo|"Participants will receive a placebo pill to take twice a day for 12 weeks.~Placebo: Health education counseling will be provided to all participants."
11224542|NCT02360631|BG002|Baseline|Total|Total of all reporting groups
11224543|NCT02360631|FG000|Participant Flow|Chantix (Varenicline)|"Participants will receive 1mg pills to take twice a day for 12 weeks.~Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking."
11224544|NCT02360631|FG001|Participant Flow|Placebo|"Participants will receive a placebo pill to take twice a day for 12 weeks.~Placebo: Health education counseling will be provided to all participants."
11224545|NCT02360631|OG000|Outcome|Chantix (Varenicline)|"Participants will receive 1mg pills to take twice a day for 12 weeks.~Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking."
11224546|NCT02360631|OG001|Outcome|Placebo|"Participants will receive a placebo pill to take twice a day for 12 weeks.~Placebo: Health education counseling will be provided to all participants."
10879723|NCT00459368|BG000|Baseline|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
10879724|NCT00459368|BG001|Baseline|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
10879725|NCT00459368|BG002|Baseline|Total|Total of all reporting groups
11009379|NCT01101477|BG001|Baseline|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11224547|NCT02360631|EG000|Reported Event|Chantix (Varenicline)|"Participants will receive 1mg pills to take twice a day for 12 weeks.~Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking."
11224548|NCT02360631|EG001|Reported Event|Placebo|"Participants will receive a placebo pill to take twice a day for 12 weeks.~Placebo: Health education counseling will be provided to all participants."
10879726|NCT00459368|FG000|Participant Flow|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
10879727|NCT00459368|FG001|Participant Flow|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
11009380|NCT01101477|BG002|Baseline|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11009381|NCT01101477|BG003|Baseline|Total|Total of all reporting groups
11224549|NCT02360774|BG000|Baseline|Placebo|"Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.~Placebo: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks."
11224550|NCT02360774|BG001|Baseline|Canagliflozin|"Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.~Canagliflozin: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks."
11224551|NCT02360774|BG002|Baseline|Total|Total of all reporting groups
11224552|NCT02360774|FG000|Participant Flow|Canagliflozin|Subjects will take one 300mg capsule of canagliflozin once daily for 18 weeks.
11224553|NCT02360774|FG001|Participant Flow|Placebo|Subjects will take one 300mg capsule of identically dispensed placebo by mouth once daily for 18 weeks.
11224554|NCT02360774|OG000|Outcome|Canagliflozin|Subjects will take one 300mg capsule of canagliflozin once daily for 18 weeks.
11224555|NCT02360774|OG001|Outcome|Placebo|Subjects will take one 300mg capsule of identically dispensed placebo by mouth once daily for 18 weeks.
11224556|NCT02360774|OG000|Outcome|Canagliflozin|"Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.~Canagliflozin: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks."
11224557|NCT02360774|OG001|Outcome|Placebo|"Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.~Placebo: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks."
11224558|NCT02360774|EG000|Reported Event|Placebo|"Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.~Placebo: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks."
11139219|NCT01809327|FG004|Participant Flow|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
11139220|NCT01809327|OG000|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
11139221|NCT01809327|OG001|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
11139222|NCT01809327|OG002|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
11139223|NCT01809327|OG003|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
11139224|NCT01809327|OG004|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
11139225|NCT01809327|EG000|Reported Event|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
11139226|NCT01809327|EG001|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
11139227|NCT01809327|EG002|Reported Event|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
11139228|NCT01809327|EG003|Reported Event|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
11139229|NCT01809327|EG004|Reported Event|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
11139230|NCT01809639|BG000|Baseline|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
11139231|NCT01809639|BG001|Baseline|Placebo|Placebo: Standard placebo for 5 days
11139232|NCT01809639|BG002|Baseline|Total|Total of all reporting groups
11139233|NCT01809639|FG000|Participant Flow|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
11139234|NCT01809639|FG001|Participant Flow|Placebo|Placebo: Standard placebo for 5 days
11139235|NCT01809639|OG000|Outcome|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
11139236|NCT01809639|OG001|Outcome|Placebo|Placebo: Standard placebo for 5 days
11139237|NCT01809639|EG000|Reported Event|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
11139238|NCT01809639|EG001|Reported Event|Placebo|Placebo: Standard placebo for 5 days
11139239|NCT01809834|BG000|Baseline|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
11139240|NCT01809834|FG000|Participant Flow|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simulataneously~Etafilcon A~Stenfilcon A"
11139241|NCT01809834|OG000|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
11139242|NCT01809834|OG001|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
10887425|NCT00500331|OG006|Outcome|Pioglitazone 30mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
10887426|NCT00500331|EG000|Reported Event|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
11139243|NCT01809834|OG000|Outcome|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
11139244|NCT01809834|EG000|Reported Event|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other~Etafilcon A~Stenfilcon A"
11139245|NCT01809938|BG000|Baseline|Entire Study Population|Includes all participants in this crossover trial
11139246|NCT01809938|FG000|Participant Flow|Black Tea First, Then Tea With Milk|Effects on gastric emptying of Black tea (300ml of tea without milk) were assessed then after a period of not less than 24 hours the effects of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed
11139247|NCT01809938|FG001|Participant Flow|Tea With Milk First Then Black Tea|Effects on gastric emptying of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed then after a period of not less than 24 hours the effects of Black tea (300ml of tea without milk) were assessed.
11139248|NCT01809938|OG000|Outcome|Black Tea|Black tea : 300ml of tea without milk
11139249|NCT01809938|OG001|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
11139250|NCT01809938|EG000|Reported Event|Entire Study Population|Includes all participants in this crossover trial
11139251|NCT01810016|BG000|Baseline|Arm A (Ipi, NY-ESO-1 Protein)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139252|NCT01810016|BG001|Baseline|Arm B (Ipi, NY-ESO-1 OLP4)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139253|NCT01810016|BG002|Baseline|Arm C (Ipi, NY-ESO-1 OLP4)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139254|NCT01810016|BG003|Baseline|Total|Total of all reporting groups
11139255|NCT01810016|FG000|Participant Flow|Arm A (Ipi, NY-ESO-1 Protein)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139256|NCT01810016|FG001|Participant Flow|Arm B (Ipi, NY-ESO-1 OLP4)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139257|NCT01810016|FG002|Participant Flow|Arm C (Ipi, NY-ESO-1 OLP4)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139258|NCT01810016|OG000|Outcome|Arm A (Ipi, NY-ESO-1 Protein)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139259|NCT01810016|OG001|Outcome|Arm B (Ipi, NY-ESO-1 OLP4)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139260|NCT01810016|OG002|Outcome|Arm C (Ipi, NY-ESO-1 OLP4)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139261|NCT01810016|EG000|Reported Event|Arm A (Ipi, NY-ESO-1 Protein)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139262|NCT01810016|EG001|Reported Event|Arm B (Ipi, NY-ESO-1 OLP4)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139263|NCT01810016|EG002|Reported Event|Arm C (Ipi, NY-ESO-1 OLP4)|"Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.~NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses."
11139264|NCT01810042|BG000|Baseline|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
11139265|NCT01810042|FG000|Participant Flow|Ranibizumab|"Ranibizumab is injected monthly 3 times then pro re nata (PRN) to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
11139266|NCT01810042|OG000|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
11139267|NCT01810042|EG000|Reported Event|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
11139268|NCT01810263|BG000|Baseline|High Protein Supplement|high protein supplement given
11139269|NCT01810263|BG001|Baseline|Control|no intervention
11139270|NCT01810263|BG002|Baseline|Total|Total of all reporting groups
11139271|NCT01810263|FG000|Participant Flow|High Protein Supplement|"Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day.~(As a result, additional calories are 600kcal a day)"
11139272|NCT01810263|FG001|Participant Flow|Control|Patients in the both groups keep on routine diet in the hospital. No additional calories are provided.
11139273|NCT01810263|OG000|Outcome|High Protein Supplement|high protein supplement given
11139274|NCT01810263|OG001|Outcome|Control|no intervention
11139275|NCT01810263|EG000|Reported Event|High Protein Supplement|high protein supplement given
11139276|NCT01810263|EG001|Reported Event|Control|no intervention
11139277|NCT01810289|BG000|Baseline|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
11139278|NCT01810289|BG001|Baseline|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
11139279|NCT01810289|BG002|Baseline|Total|Total of all reporting groups
11139280|NCT01810289|FG000|Participant Flow|Pre-intervention|This study is stepped-wedge in design, therefore each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. In the pre-intervention condition the clinic is using the standard of care.
11139281|NCT01810289|FG001|Participant Flow|Post-intervention|"This study is stepped-wedge in design, therefore each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. In the intervention condition (post-intervention) the clinics have received the intervention - training, ongoing feedback, as well as the point of care CD4 (PIMA) machine."
11139282|NCT01810289|OG000|Outcome|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the pre-intervention condition are giving the standard of care.
11139283|NCT01810289|OG001|Outcome|Post-intervention|"This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the intervention (post-intervention) have experienced training, ongoing feedback and have the PIMA machine."
11139284|NCT01810289|EG000|Reported Event|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
11139285|NCT01810289|EG001|Reported Event|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
11139286|NCT01810380|BG000|Baseline|Placebo|Placebo: Once daily as tablets and capsules, orally
11139287|NCT01810380|BG001|Baseline|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
11139288|NCT01810380|BG002|Baseline|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
11139289|NCT01810380|BG003|Baseline|Total|Total of all reporting groups
11139290|NCT01810380|FG000|Participant Flow|Placebo|Placebo: Once daily as tablets and capsules, orally
11139291|NCT01810380|FG001|Participant Flow|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
11139292|NCT01810380|FG002|Participant Flow|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
11139293|NCT01810380|OG000|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
11139294|NCT01810380|OG001|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
11139295|NCT01810380|OG002|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
11139296|NCT01810380|EG000|Reported Event|Placebo|Placebo: Once daily as tablets and capsules, orally
11139297|NCT01810380|EG001|Reported Event|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
11139298|NCT01810380|EG002|Reported Event|Quetiapine|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
11139299|NCT01810432|BG000|Baseline|Evacetrapib|"Sequence 1-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) in a fasted state. Following a 14-day washout period, participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.~Sequence 2-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state."
10887427|NCT00500331|EG001|Reported Event|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11139300|NCT01810432|FG000|Participant Flow|Sequence 1 (Fast/Fed)|Participants received a 130 milligram (mg) oral tablet of evacetrapib once daily (QD) for 10 days (Period 1) in a fasted state. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.
11139301|NCT01810432|FG001|Participant Flow|Sequence 2 (Fed/Fasted)|Participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state.
11139302|NCT01810432|OG000|Outcome|Evacetrapib (Fasted)|Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.
11139303|NCT01810432|OG001|Outcome|Evacetrapib (Fed)|Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
11139304|NCT01810432|EG000|Reported Event|Evacetrapib (Fasted)|Participants received 130-mg oral tablet fo evacetrapib QD in a fasted state for 10 days.
11139305|NCT01810432|EG001|Reported Event|Evacetrapib (Fed)|Participants received 130-mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
11139306|NCT01810666|BG000|Baseline|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
11139307|NCT01810666|FG000|Participant Flow|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
11139308|NCT01810666|OG000|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
11139309|NCT01810666|EG000|Reported Event|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
11139310|NCT01810692|BG000|Baseline|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
11139311|NCT01810692|BG001|Baseline|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
10887428|NCT00500331|EG002|Reported Event|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11009382|NCT01101477|FG000|Participant Flow|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11139312|NCT01810692|BG002|Baseline|Total|Total of all reporting groups
11139313|NCT01810692|FG000|Participant Flow|Spiriva Respimat|Patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
11139314|NCT01810692|FG001|Participant Flow|Hirobriz/Onbrez/Oslif Breezhaler|Patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
10887429|NCT00500331|EG003|Reported Event|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11139315|NCT01810692|OG000|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
11139316|NCT01810692|OG001|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
11139317|NCT01810692|EG000|Reported Event|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
11139318|NCT01810692|EG001|Reported Event|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
11139319|NCT01810783|BG000|Baseline|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
11139320|NCT01810783|FG000|Participant Flow|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
11139321|NCT01810783|OG000|Outcome|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
11139322|NCT01810783|EG000|Reported Event|Brexpiprazole|210 were enrolled, only 209 patients were treated with brexpiprazole
11139323|NCT01810939|BG000|Baseline|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
11139324|NCT01810939|FG000|Participant Flow|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
11139325|NCT01810939|FG001|Participant Flow|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
11139326|NCT01810939|FG002|Participant Flow|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
11139327|NCT01810939|OG000|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
11139328|NCT01810939|OG000|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
11139329|NCT01810939|OG001|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
11139330|NCT01810939|OG000|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks. The dose of patiromer could be titrated based on participant's serum potassium response.
11139331|NCT01810939|EG000|Reported Event|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
11139332|NCT01810939|EG001|Reported Event|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
11139333|NCT01810939|EG002|Reported Event|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
11139334|NCT01810952|BG000|Baseline|Glargine/Lispro Insulin Arm|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
11139335|NCT01810952|BG001|Baseline|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
11139336|NCT01810952|BG002|Baseline|Total|Total of all reporting groups
11139337|NCT01810952|FG000|Participant Flow|Glargine/Lispro Insulin|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
11139338|NCT01810952|FG001|Participant Flow|Glargine/Lispro/NPH Insulin|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
11139339|NCT01810952|OG000|Outcome|Glargine/Lispro Insulin Arm|"The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting coverage dose will be 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL."
11139340|NCT01810952|OG001|Outcome|Glargine/Lispro/NPH Insulin Arm|"Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day.~Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day."
11139341|NCT01810952|OG000|Outcome|Glargine/Lispro Insulin Arm|Last Full Day of Protocol
11139342|NCT01810952|OG001|Outcome|Glargine/Lispro/NPH Insulin Arm|Last Full Day of Protocol
11139343|NCT01810952|OG000|Outcome|Glargine/Lispro Insulin Arm|Insulin (units)/kg body weight
11139344|NCT01810952|OG001|Outcome|Glargine/Lispro/NPH Insulin Arm|Insulin (units)/kg body weight
11139345|NCT01810952|OG000|Outcome|Glargine/Lispro Insulin Arm|
11139346|NCT01810952|OG001|Outcome|Glargine/Lispro/NPH Insulin Arm|
11139347|NCT01810952|EG000|Reported Event|Glargine/Lispro Insulin Arm|"The G/L Arm received 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
11139348|NCT01810952|EG001|Reported Event|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro were similar to those in the G/L/N Protocol. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
11139349|NCT01810991|BG000|Baseline|Nd:YAG Laser|"Nd:YAG 1440nm Laser~Nd:YAG Laser: Nd:YAG 1440nm Laser"
11139350|NCT01810991|FG000|Participant Flow|Nd:YAG Laser|"Nd:YAG 1440nm Laser~Nd:YAG Multiwavelength Diode Laser Using 1440nm Wavelength. A Rep Rate of 25 Hz was used.~Each subject received 1 treatment using this laser."
11139351|NCT01810991|OG000|Outcome|Nd:YAG Laser|"Nd:YAG 1440nm Laser~Nd:YAG Laser: Nd:YAG 1440nm Laser"
11139352|NCT01810991|EG000|Reported Event|Nd:YAG Laser|"Nd:YAG 1440nm Laser~Nd:YAG Laser: Nd:YAG 1440nm Laser"
11139353|NCT01811004|BG000|Baseline|Nd: YAG Laser- miraDry|"Nd: YAG laser 1440nm~miraDry: miraDry"
11139354|NCT01811004|BG001|Baseline|Nd: YAG Laser- Botox|"Nd:YAG Laser: Nd:YAG 1440 nm Laser~Botox®: Botox®"
11139355|NCT01811004|BG002|Baseline|Total|Total of all reporting groups
11139356|NCT01811004|FG000|Participant Flow|Nd: YAG Laser and miraDry|"Nd: YAG laser 1440nm and miraDry~For each patient, one axilla was treated with the 1440 nm Diode laser and the opposite axilla was treated with miraDry. The subject is treated with miraDry at day 0, and again at day 90.~Nd:YAG Laser: Nd:YAG 1440 nm Diode Laser with a Rep Rate of 25 Hz. Total energy around 1500 J per 5cm x 5cm sector."
11139357|NCT01811004|FG001|Participant Flow|Nd: YAG Laser 1440nm and Botox|"Nd: YAG laser 1440nm and Botox~For each patient, one axilla was treated with the 1440 nm Diode laser and the opposite axilla was treated with Botox.~Nd:YAG Laser: Nd:YAG 1440 nm Diode Laser with a Rep Rate of 25 Hz. Total energy around 1500 J per 5cm x 5cm sector."
11139358|NCT01811004|OG000|Outcome|Botox®|"Botox®~Nd:YAG Laser: Nd:YAG 1440 nm Laser~Botox®: Botox®"
11139359|NCT01811004|OG001|Outcome|miraDry®|"miraDry®~miraDry: miraDry~Nd:YAG Laser: Nd:YAG 1440 nm Laser"
11139360|NCT01811004|OG002|Outcome|Nd: YAG Laser|Nd: YAG laser 1440nm
11139361|NCT01811004|EG000|Reported Event|Botox®|Botox® and Nd:YAG Laser: 1440 nm Laser
11139362|NCT01811004|EG001|Reported Event|miraDry®|miraDry® and Nd:YAG 1440 nm Laser
11139363|NCT01811004|EG002|Reported Event|Nd: YAG Laser|Nd: YAG laser: 1440nm
11139364|NCT01811030|BG000|Baseline|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser"
11139365|NCT01811030|FG000|Participant Flow|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser"
11139366|NCT01811030|OG000|Outcome|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser"
11139367|NCT01811030|EG000|Reported Event|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser"
11139368|NCT01811147|BG000|Baseline|High Risk Depression|"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.~Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."
11139369|NCT01811147|BG001|Baseline|Low Risk Depression|"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..~Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."
11139370|NCT01811147|BG002|Baseline|Healthy Control|There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
11139371|NCT01811147|BG003|Baseline|Bipolar|Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
11139372|NCT01811147|BG004|Baseline|Total|Total of all reporting groups
11139373|NCT01811147|FG000|Participant Flow|High Risk Depression|"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.~Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."
11139374|NCT01811147|FG001|Participant Flow|Low Risk Depression|"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..~Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."
11139375|NCT01811147|FG002|Participant Flow|Healthy Control|There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
11139376|NCT01811147|FG003|Participant Flow|Bipolar|Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
11139377|NCT01811147|OG000|Outcome|High Risk Depression|"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.~Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."
11139378|NCT01811147|OG001|Outcome|Low Risk Depression|"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..~Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."
11139379|NCT01811147|OG002|Outcome|Healthy Control|There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
11139380|NCT01811147|OG003|Outcome|Bipolar|Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
11139381|NCT01811147|EG000|Reported Event|High Risk Depression|"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.~Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."
11139382|NCT01811147|EG001|Reported Event|Low Risk Depression|"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..~Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."
11139383|NCT01811147|EG002|Reported Event|Healthy Control|There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
11139384|NCT01811147|EG003|Reported Event|Bipolar|Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
11139385|NCT01811186|BG000|Baseline|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139386|NCT01811186|BG001|Baseline|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139387|NCT01811186|BG002|Baseline|Total|Total of all reporting groups
11139388|NCT01811186|FG000|Participant Flow|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139389|NCT01811186|FG001|Participant Flow|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139390|NCT01811186|OG000|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
11139391|NCT01811186|OG001|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139392|NCT01811186|OG000|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
11139393|NCT01811186|OG001|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139394|NCT01811186|OG000|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139395|NCT01811186|OG001|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139396|NCT01811186|EG000|Reported Event|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139397|NCT01811186|EG001|Reported Event|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
11139398|NCT01811212|BG000|Baseline|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11139399|NCT01811212|FG000|Participant Flow|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11139400|NCT01811212|OG000|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11139401|NCT01811212|EG000|Reported Event|Treatment (Cabozantinib-s-malate)|"Patients receive cabozantinib-s-malate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11139402|NCT01811225|BG000|Baseline|All Participants|All participants at baseline
11139403|NCT01811225|FG000|Participant Flow|Low-Dose Contraceptive, Then High-Dose|"Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium.~Participants in this arm will begin with the low dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the high dose progesterone, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM)."
11139404|NCT01811225|FG001|Participant Flow|High-Dose Contraceptive, Then Low-Dose|"Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium.~Participants in this arm will begin with the high progesterone dose, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the low dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM)."
10887430|NCT00500331|EG004|Reported Event|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
10887431|NCT00500331|EG005|Reported Event|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
11139405|NCT01811225|OG000|Outcome|Low-Dose Contraceptive|"Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a low-dose contraceptive.~The low progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM)."
11139406|NCT01811225|OG001|Outcome|High-Dose Contraceptive|"Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a high-dose contraceptive.~The high progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM)."
11139407|NCT01811225|EG000|Reported Event|Low-Dose Contraceptive|"Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a low-dose contraceptive.~The low progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM)."
11139408|NCT01811225|EG001|Reported Event|High-Dose Contraceptive|"Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a high-dose contraceptive.~The high progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM)."
11139409|NCT01811238|BG000|Baseline|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
11139410|NCT01811238|FG000|Participant Flow|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
11139411|NCT01811238|OG000|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
11139412|NCT01811238|OG000|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/naloxone: Targin 5mg, 10mg, 20mg up to 40mg b.i.d"
11139413|NCT01811238|EG000|Reported Event|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
11139414|NCT01811303|BG000|Baseline|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water vs placebo.
11139415|NCT01811303|FG000|Participant Flow|Placebo, Placebo, Treatment, Treatment|The subjects receive placebo in the first two interventions.
11139416|NCT01811303|FG001|Participant Flow|Treatment, Treatment, Placebo, Placebo|The subjects receive treatment in the first two interventions
11139417|NCT01811303|FG002|Participant Flow|Placebo, Treatment, Placebo, Treatment|The subjects receive placebo or treatment in each intervention alternatively, starting with placebo.
11139418|NCT01811303|FG003|Participant Flow|Treatment, Placebo, Treatment, Placebo|The subjects receive placebo or treatment in each intervention alternatively, starting with treatment.
11139419|NCT01811303|OG000|Outcome|Change D-fagomine/Control AUC at 60 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 60 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
11139420|NCT01811303|OG001|Outcome|Change D-fagomine/Control AUC at 120 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 120 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
11139421|NCT01811303|OG000|Outcome|D-fagomine|Determination of glucose Cmax over the Baseline of the treatment: sucrose 50 g + 200 ml water + 40 mg D-fagomine. Blood glucose concentration expressed in mmol/l.
11139422|NCT01811303|OG001|Outcome|Control|Determination of glucose Cmax over the Baseline of the control: sucrose 50 g + 200 ml water. Blood glucose concentration expressed in mmol/l.
11139423|NCT01811303|EG000|Reported Event|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water.
11139424|NCT01811303|EG001|Reported Event|Placebo - Control (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g sucrose in 200 ml water (without d-fagomine)
11139425|NCT01811316|BG000|Baseline|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
11139426|NCT01811316|BG001|Baseline|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
11139427|NCT01811316|BG002|Baseline|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
11139428|NCT01811316|BG003|Baseline|Total|Total of all reporting groups
11139429|NCT01811316|FG000|Participant Flow|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
11139430|NCT01811316|FG001|Participant Flow|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
11139431|NCT01811316|FG002|Participant Flow|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
11139432|NCT01811316|OG000|Outcome|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
11139433|NCT01811316|OG001|Outcome|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
11139434|NCT01811316|OG002|Outcome|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
11139435|NCT01811316|EG000|Reported Event|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
11139436|NCT01811316|EG001|Reported Event|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
11139437|NCT01811316|EG002|Reported Event|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
11139438|NCT01811355|BG000|Baseline|Total Subjects Enrolled|A total of 23 subjects were enrolled. 11 were randomized to receive study drug first, followed by placebo. 12 subjects received placebo first and study drug second. Overall participant characteristics are displayed in the baseline table.
10887432|NCT00500331|EG006|Reported Event|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
11139439|NCT01811355|FG000|Participant Flow|Mexiletine First/Placebo Second|"Mexiletine, capsule, 150mg, PO BID, 14 days~Placebo, capsule, PO BID, 14 days"
11139440|NCT01811355|FG001|Participant Flow|Placebo First/Mexiletine Second|"Placebo, capsule, PO BID, 14 days~Mexiletine, capsule, 150mg, PO BID, 14 days"
11139441|NCT01811355|OG000|Outcome|Mexiletine First/Placebo Second|"Mexiletine, capsule, 150mg, PO BID, 14 days~Placebo, capsule, PO BID, 14 days"
11139442|NCT01811355|OG001|Outcome|Placebo First/Mexiletine Second|"Placebo, capsule, PO BID, 14 days~Mexiletine, capsule, 150mg, PO BID, 14 days"
11139443|NCT01811355|OG000|Outcome|Mexiletine First|"Mexiletine, capsule, 150mg, PO BID, 14 days~Mexiletine: Sodium channel blocker"
11139444|NCT01811355|OG001|Outcome|Placebo First|"Placebo, capsule, PO BID, 14 days~Placebo: Placebo"
11139445|NCT01811355|EG000|Reported Event|Mexiletine|"Mexiletine, capsule, 150mg, PO BID, 14 days~Mexiletine: Sodium channel blocker"
11139446|NCT01811355|EG001|Reported Event|Placebo|"Placebo, capsule, PO BID, 14 days~Placebo: Placebo"
11139447|NCT01811472|BG000|Baseline|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139448|NCT01811472|BG001|Baseline|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139449|NCT01811472|BG002|Baseline|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139450|NCT01811472|BG003|Baseline|Total|Total of all reporting groups
11009383|NCT01101477|FG001|Participant Flow|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11139451|NCT01811472|FG000|Participant Flow|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139452|NCT01811472|FG001|Participant Flow|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139453|NCT01811472|FG002|Participant Flow|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139454|NCT01811472|OG000|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139455|NCT01811472|OG001|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139456|NCT01811472|OG002|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139457|NCT01811472|EG000|Reported Event|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139458|NCT01811472|EG001|Reported Event|Pradigastat (LCQ908) 5mg /10 mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139459|NCT01811472|EG002|Reported Event|Pradigastat (LCQ908) 10mg/20 mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
11139460|NCT01811472|EG003|Reported Event|Pooled Pradigastat (LCQ908)|This arm included all patients randomized to pradigastat (LCQ908) 5mg/10 mg and pradigastat (LCQ908)10mg/20 mg
11139461|NCT01811485|BG000|Baseline|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
11139462|NCT01811485|BG001|Baseline|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
11139463|NCT01811485|BG002|Baseline|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
11139464|NCT01811485|BG003|Baseline|Total|Total of all reporting groups
11139465|NCT01811485|FG000|Participant Flow|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
11139466|NCT01811485|FG001|Participant Flow|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
11139467|NCT01811485|FG002|Participant Flow|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
11139468|NCT01811485|OG000|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
11139469|NCT01811485|OG001|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
11139470|NCT01811485|OG000|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
11139471|NCT01811485|OG001|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
11139472|NCT01811485|OG002|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
11139473|NCT01811485|EG000|Reported Event|POOLED LMF237|All patients who has received LMF237
11139474|NCT01811485|EG001|Reported Event|LMF237 50/250mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
11139475|NCT01811485|EG002|Reported Event|LMF237 50/500mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
11139476|NCT01811485|EG003|Reported Event|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
11139477|NCT01811563|BG000|Baseline|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
11139478|NCT01811563|BG001|Baseline|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
11139479|NCT01811563|BG002|Baseline|Total|Total of all reporting groups
11139480|NCT01811563|FG000|Participant Flow|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
11139481|NCT01811563|FG001|Participant Flow|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
11139482|NCT01811563|OG000|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
11139483|NCT01811563|OG001|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
11139484|NCT01811563|EG000|Reported Event|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
11139485|NCT01811563|EG001|Reported Event|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
11139486|NCT01811654|BG000|Baseline|Intra-Articular Hyaluronic Acid-Euflexxa|Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms.
11139487|NCT01811654|BG001|Baseline|Standard Care|Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented.
11139488|NCT01811654|BG002|Baseline|Total|Total of all reporting groups
11139489|NCT01811654|FG000|Participant Flow|Standard Care|Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented.
11139490|NCT01811654|FG001|Participant Flow|Intra-Articular Hyaluronic Acid-Euflexxa|"Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms.~Intra-Articular Hyaluronic Acid-Euflexxa: IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA."
11139491|NCT01811654|OG000|Outcome|Standard Care|Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented.
11139492|NCT01811654|OG001|Outcome|Intra-Articular Hyaluronic Acid-Euflexxa|"Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms.~Intra-Articular Hyaluronic Acid-Euflexxa: IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA."
11139493|NCT01811654|EG000|Reported Event|Standard Care|Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented.
11139494|NCT01811654|EG001|Reported Event|Intra-Articular Hyaluronic Acid-Euflexxa|"Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms.~Intra-Articular Hyaluronic Acid-Euflexxa: IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA."
11139495|NCT01811680|BG000|Baseline|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
11139496|NCT01811680|FG000|Participant Flow|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
11139497|NCT01811680|OG000|Outcome|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
11139498|NCT01811680|OG000|Outcome|Supervised Treadmill Training|Supervised treadmill training on variable sensing treadmill.
11139499|NCT01811680|EG000|Reported Event|Supervised Treadmill Training|Research Intervention: Supervised treadmill training on variable sensing treadmill.
11139500|NCT01811693|BG000|Baseline|Dose Tier 1|"Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal~Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal"
11139501|NCT01811693|BG001|Baseline|Dose Tier 2|"Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal~Glycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal"
11139502|NCT01811693|BG002|Baseline|Dose Tier 3|"Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN~Glycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal~Glycerly Trinitrate: 0.4 mg sublingual single metered spray"
11139503|NCT01811693|BG003|Baseline|Total|Total of all reporting groups
11139504|NCT01811693|FG000|Participant Flow|Dose Tier 1|"Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal~Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal"
11139505|NCT01811693|FG001|Participant Flow|Dose Tier 2|"Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal~Glycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal"
11139506|NCT01811693|FG002|Participant Flow|Dose Tier 3|"Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN~Glycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal~Glycerly Trinitrate: 0.4 mg sublingual single metered spray"
11139507|NCT01811693|OG000|Outcome|Dose Tier 1|"Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal~Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal"
11139508|NCT01811693|EG000|Reported Event|Dose Tier 1|"Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal~Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal"
11139509|NCT01811706|BG000|Baseline|All Study Participants|
11139510|NCT01811706|FG000|Participant Flow|Dalfampridine and Then Placebo|"Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.~Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period~Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
11139511|NCT01811706|FG001|Participant Flow|Placebo, Then Dalfampridine|"Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.~Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period~Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
11139512|NCT01811706|OG000|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
11139513|NCT01811706|OG001|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
11139514|NCT01811706|OG000|Outcome|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
11139515|NCT01811706|OG001|Outcome|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
11139516|NCT01811706|EG000|Reported Event|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
11139517|NCT01811706|EG001|Reported Event|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
11139518|NCT01811732|BG000|Baseline|Delafloxacin + Placebo|"300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
11139519|NCT01811732|BG001|Baseline|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
11139520|NCT01811732|BG002|Baseline|Total|Total of all reporting groups
11139521|NCT01811732|FG000|Participant Flow|Delafloxacin Plus Placebo|"300 mg IV every 12 hours, for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
11139522|NCT01811732|FG001|Participant Flow|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
11139523|NCT01811732|OG000|Outcome|Delafloxacin Plus Placebo|"300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
11139524|NCT01811732|OG001|Outcome|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
11139525|NCT01811732|OG000|Outcome|Delafloxacin Plus Placebo|"300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
11139526|NCT01811732|EG000|Reported Event|Delafloxacin Plus Placebo|"300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
11139527|NCT01811732|EG001|Reported Event|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
11139528|NCT01811875|BG000|Baseline|Optivate 500IU|"Optivate 500IU~Optivate 500IU"
11139529|NCT01811875|FG000|Participant Flow|Optivate 500IU|"Optivate 500IU~Optivate 500IU"
11139530|NCT01811875|OG000|Outcome|Optivate 500IU|"Optivate 500IU~Optivate 500IU"
11139531|NCT01811875|EG000|Reported Event|Optivate 500IU|"Optivate 500IU~Optivate 500IU"
11139532|NCT01811940|BG000|Baseline|Adderall-ER and Topiramate|"Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.~Adderall-ER: MAS-ER 60mg/day~Topiramate: Topiramate 100 mg bid."
11139533|NCT01811940|BG001|Baseline|Placebo|"Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.~Placebo: Placebo"
11139534|NCT01811940|BG002|Baseline|Total|Total of all reporting groups
11139535|NCT01811940|FG000|Participant Flow|Adderall-ER and Topiramate|"Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.~Adderall-ER: MAS-ER 60mg/day~Topiramate: Topiramate 100 mg bid."
11139536|NCT01811940|FG001|Participant Flow|Placebo|"Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.~Placebo: Placebo"
11139537|NCT01811940|OG000|Outcome|Adderall-ER and Topiramate|"Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.~Adderall-ER: MAS-ER 60mg/day~Topiramate: Topiramate 100 mg bid."
11139538|NCT01811940|OG001|Outcome|Placebo|"Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.~Placebo: Placebo"
11139539|NCT01811940|EG000|Reported Event|Adderall-ER and Topiramate|"Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.~Adderall-ER: MAS-ER 60mg/day~Topiramate: Topiramate 100 mg bid."
11139540|NCT01811940|EG001|Reported Event|Placebo|"Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.~Placebo: Placebo"
11139541|NCT01811953|BG000|Baseline|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139542|NCT01811953|BG001|Baseline|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139543|NCT01811953|BG002|Baseline|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139544|NCT01811953|BG003|Baseline|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139545|NCT01811953|BG004|Baseline|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139546|NCT01811953|BG005|Baseline|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139547|NCT01811953|BG006|Baseline|Total|Total of all reporting groups
11139548|NCT01811953|FG000|Participant Flow|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139549|NCT01811953|FG001|Participant Flow|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139550|NCT01811953|FG002|Participant Flow|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139551|NCT01811953|FG003|Participant Flow|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11009384|NCT01101477|FG002|Participant Flow|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11139552|NCT01811953|FG004|Participant Flow|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139553|NCT01811953|FG005|Participant Flow|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
11139554|NCT01811953|OG000|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
11139555|NCT01811953|OG001|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
11139556|NCT01811953|OG002|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
11139557|NCT01811953|OG003|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
11139558|NCT01811953|OG004|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
11139559|NCT01811953|OG005|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
11139560|NCT01811953|EG000|Reported Event|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
11139561|NCT01811953|EG001|Reported Event|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
11139562|NCT01811953|EG002|Reported Event|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
11139563|NCT01811953|EG003|Reported Event|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
11139564|NCT01811953|EG004|Reported Event|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
11139565|NCT01811953|EG005|Reported Event|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
11139566|NCT01812005|BG000|Baseline|Cohort A (Alisertib, Rituximab)|"Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~alisertib: Given PO~rituximab: Given IV~laboratory biomarker analysis: Laboratory correlative studies will be performed"
11139567|NCT01812005|BG001|Baseline|Cohort B (Alisertib, Rituximab)|"Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~alisertib: Given PO~rituximab: Given IV~laboratory biomarker analysis: Laboratory correlative studies will be performed"
11139568|NCT01812005|BG002|Baseline|Total|Total of all reporting groups
11139569|NCT01812005|FG000|Participant Flow|Cohort A (Alisertib, Rituximab)|"Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~alisertib: Given PO~rituximab: Given IV~laboratory biomarker analysis: Laboratory correlative studies will be performed"
11139570|NCT01812005|FG001|Participant Flow|Cohort B (Alisertib, Rituximab)|"Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~alisertib: Given PO~rituximab: Given IV~laboratory biomarker analysis: Laboratory correlative studies will be performed"
11139571|NCT01812005|OG000|Outcome|Cohort A (Alisertib, Rituximab)|"Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~alisertib: Given PO~rituximab: Given IV~laboratory biomarker analysis: Laboratory correlative studies will be performed"
11139572|NCT01812005|OG001|Outcome|Cohort B (Alisertib, Rituximab)|"Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~alisertib: Given PO~rituximab: Given IV~laboratory biomarker analysis: Laboratory correlative studies will be performed"
11139573|NCT01812005|EG000|Reported Event|Cohort A|Cohort A: Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11139574|NCT01812005|EG001|Reported Event|Cohort B|Cohort B: Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11139575|NCT01812044|BG000|Baseline|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
11139576|NCT01812044|BG001|Baseline|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
11139577|NCT01812044|BG002|Baseline|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
11139578|NCT01812044|BG003|Baseline|Total|Total of all reporting groups
11139579|NCT01812044|FG000|Participant Flow|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
11139580|NCT01812044|FG001|Participant Flow|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
11139581|NCT01812044|FG002|Participant Flow|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
11139582|NCT01812044|OG000|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
11139583|NCT01812044|OG001|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
11139584|NCT01812044|OG002|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
11139585|NCT01812044|EG000|Reported Event|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
11139586|NCT01812044|EG001|Reported Event|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
11139587|NCT01812044|EG002|Reported Event|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
11139588|NCT01812057|BG000|Baseline|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
11139589|NCT01812057|BG001|Baseline|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
11139590|NCT01812057|BG002|Baseline|Total|Total of all reporting groups
11139591|NCT01812057|FG000|Participant Flow|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
11139592|NCT01812057|FG001|Participant Flow|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
11139593|NCT01812057|OG000|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
11139594|NCT01812057|OG001|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
11139595|NCT01812057|OG000|Outcome|Positive MTS Score|Positive MTS score is defined as change of >1 in MTS score between 1st tap and 11th tap of 180 gram von Frey filament.
11139596|NCT01812057|OG001|Outcome|Negative MTS Score|Negative MTS score is defines as change of less than or equal to 1 in MTS scores between 1st tap and 11th tap.
11139597|NCT01812057|OG000|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
11139598|NCT01812057|OG001|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
11139599|NCT01812057|EG000|Reported Event|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
11139600|NCT01812057|EG001|Reported Event|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
11139601|NCT01812109|BG000|Baseline|NIRS|There is only 1 group in this non randomized pilot study. Those patients with acute scrotum defined as painful scrotum or testes, abdominal pain +/- nausea and vomiting, waddling gain (cowboy shuffle) .
11139602|NCT01812109|FG000|Participant Flow|NIRS|There is only 1 group in this non randomized pilot study. Those patients with acute scrotum defined as painful scrotum or testes, abdominal pain +/- nausea and vomiting, waddling gain (cowboy shuffle) .
11139603|NCT01812109|OG000|Outcome|Hutchison Technologies Inspectra StO2 NIRS|"Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy (NIRS) evaluation of acute scrotum per protocol~Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy: Device: Near-Infrared Spectroscopy Transscrotal NIRS is a series of 6 transcutaneous scrotal measurements, 3 on both left/right. Each measurement is completely non-invasive, painless and takes ~15 seconds each. Thus, no sedation or supplemental analgesia is needed for NIRS. The NIRS probe will be placed on the anterior, lateral and posterior scrotum on the left/right sides, immediately overlying and parallel to the long axis of the testis but on the skin to obtain the 6 total measurements. The unaffected testis will serve as the patient's own control. Study coordinators will be performing the ER transscrotal NIRS testing. For uniformity, all will be trained for testicular probe placement methods. NIRS will not delay the gray scale/color Doppler testicular US or surgery."
11139604|NCT01812109|EG000|Reported Event|Hutchison Technologies Inspectra StO2 NIRS|"Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy (NIRS) evaluation of acute scrotum per protocol~Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy: Device: Near-Infrared Spectroscopy Transscrotal NIRS is a series of 6 transcutaneous scrotal measurements, 3 on both left/right. Each measurement is completely non-invasive, painless and takes ~15 seconds each. Thus, no sedation or supplemental analgesia is needed for NIRS. The NIRS probe will be placed on the anterior, lateral and posterior scrotum on the left/right sides, immediately overlying and parallel to the long axis of the testis but on the skin to obtain the 6 total measurements. The unaffected testis will serve as the patient's own control. Study coordinators will be performing the ER transscrotal NIRS testing. For uniformity, all will be trained for testicular probe placement methods. NIRS will not delay the gray scale/color Doppler testicular US or surgery."
11139605|NCT01812473|BG000|Baseline|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
11139606|NCT01812473|BG001|Baseline|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
11139607|NCT01812473|BG002|Baseline|Total|Total of all reporting groups
11139608|NCT01812473|FG000|Participant Flow|Patients Admitted to the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
11139609|NCT01812473|FG001|Participant Flow|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
11139610|NCT01812473|OG000|Outcome|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
11139611|NCT01812473|OG001|Outcome|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
11139612|NCT01812473|EG000|Reported Event|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
11139613|NCT01812473|EG001|Reported Event|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
11139614|NCT01812655|BG000|Baseline|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
11139615|NCT01812655|BG001|Baseline|Passive Distraction|watching a movie
11139616|NCT01812655|BG002|Baseline|Standard Care Provided by the Nurses|
11139617|NCT01812655|BG003|Baseline|Total|Total of all reporting groups
11139618|NCT01812655|FG000|Participant Flow|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
11139619|NCT01812655|FG001|Participant Flow|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
11139620|NCT01812655|FG002|Participant Flow|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
11139621|NCT01812655|OG000|Outcome|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
11139622|NCT01812655|OG001|Outcome|Passive Distraction|watching a movie
11139623|NCT01812655|OG002|Outcome|Standard Care Provided by the Nurses|
11139624|NCT01812655|OG000|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
11139625|NCT01812655|OG001|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
11139626|NCT01812655|OG002|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
11139627|NCT01812655|EG000|Reported Event|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
11139628|NCT01812655|EG001|Reported Event|Passive Distraction|watching a movie
11139629|NCT01812655|EG002|Reported Event|UC Provided by the Nurses|
11139630|NCT01812668|BG000|Baseline|Treatment (Cabozantinib-s-malate)|"Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.~cabozantinib-s-malate: Given PO~fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan~positron emission tomography: Undergo 18F PET/FMAU PET scan~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11139631|NCT01812668|FG000|Participant Flow|Treatment (Cabozantinib-s-malate)|"Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.~cabozantinib-s-malate: Given PO~fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan~positron emission tomography: Undergo 18F PET/FMAU PET scan~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11139632|NCT01812668|OG000|Outcome|Treatment (Cabozantinib-s-malate)|"Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.~cabozantinib-s-malate: Given PO~fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan~positron emission tomography: Undergo 18F PET/FMAU PET scan~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11139633|NCT01812668|EG000|Reported Event|Treatment (Cabozantinib-s-malate)|"Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.~cabozantinib-s-malate: Given PO~fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan~positron emission tomography: Undergo 18F PET/FMAU PET scan~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11139634|NCT01812681|BG000|Baseline|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
11139635|NCT01812681|BG001|Baseline|Normal Vitamin D|The premature infants with normal vitamin D level
11139636|NCT01812681|BG002|Baseline|Total|Total of all reporting groups
11139637|NCT01812681|FG000|Participant Flow|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
11139638|NCT01812681|FG001|Participant Flow|Normal Vitamin D|The premature infants with normal vitamin D level
11139639|NCT01812681|OG000|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
11139640|NCT01812681|OG001|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
11139641|NCT01812681|EG000|Reported Event|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
11139642|NCT01812681|EG001|Reported Event|Normal Vitamin D|The premature infants with normal vitamin D level
11139643|NCT01812707|BG000|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11139644|NCT01812707|BG001|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139645|NCT01812707|BG002|Baseline|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139646|NCT01812707|BG003|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139647|NCT01812707|BG004|Baseline|Total|Total of all reporting groups
11139648|NCT01812707|FG000|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
11139649|NCT01812707|FG001|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139650|NCT01812707|FG002|Participant Flow|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139651|NCT01812707|FG003|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139652|NCT01812707|OG000|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11139653|NCT01812707|OG001|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139654|NCT01812707|OG002|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139655|NCT01812707|OG003|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139656|NCT01812707|OG000|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12 weeks in combination with atorvastatin stable dose.
11139657|NCT01812707|EG000|Reported Event|Placebo|Placebo Q2W for 12 weeks in combination with atorvastatin stable dose.
11139658|NCT01812707|EG001|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139659|NCT01812707|EG002|Reported Event|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139660|NCT01812707|EG003|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11139661|NCT01812759|BG000|Baseline|Placebo|Placebo nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.
11139662|NCT01812759|BG001|Baseline|Intervention|Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.
11139663|NCT01812759|BG002|Baseline|No Medication|Patient consented but admitted to hospital before medication administered.
11139664|NCT01812759|BG003|Baseline|Total|Total of all reporting groups
11139665|NCT01812759|FG000|Participant Flow|Placebo|Placebo nasal spray administered in each nostril plus hydromorphone (PCA) Initial Patient Controlled Analgesia. (PCA) loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.
11139666|NCT01812759|FG001|Participant Flow|Intervention|Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.
11139667|NCT01812759|FG002|Participant Flow|No Medication|Patient consented but admitted to hospital before medication administered.
11139668|NCT01812759|OG000|Outcome|Placebo|Placebo nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.
11139669|NCT01812759|OG001|Outcome|Intervention|Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.
11139670|NCT01812759|OG002|Outcome|No Medication|Patient consented but admitted to hospital before medication administered.
11139671|NCT01812759|EG000|Reported Event|Placebo|Placebo nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.
11139672|NCT01812759|EG001|Reported Event|Intervention|Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.
11139673|NCT01812759|EG002|Reported Event|No Medication|Patient consented but admitted to hospital before medication administered.
11139674|NCT01812837|BG000|Baseline|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139675|NCT01812837|BG001|Baseline|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139676|NCT01812837|BG002|Baseline|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139677|NCT01812837|BG003|Baseline|Total|Total of all reporting groups
11139678|NCT01812837|FG000|Participant Flow|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139679|NCT01812837|FG001|Participant Flow|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139680|NCT01812837|FG002|Participant Flow|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139681|NCT01812837|OG000|Outcome|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139682|NCT01812837|OG001|Outcome|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139683|NCT01812837|OG002|Outcome|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139684|NCT01812837|EG000|Reported Event|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139685|NCT01812837|EG001|Reported Event|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139686|NCT01812837|EG002|Reported Event|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
11139687|NCT01813019|BG000|Baseline|Placebo|Matching Placebo b.i.d. dosing
11139688|NCT01813019|BG001|Baseline|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
11139689|NCT01813019|BG002|Baseline|Total|Total of all reporting groups
11139690|NCT01813019|FG000|Participant Flow|Placebo|Matching Placebo b.i.d. dosing
11139691|NCT01813019|FG001|Participant Flow|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
11139692|NCT01813019|OG000|Outcome|Placebo|Matching Placebo b.i.d. dosing
11139693|NCT01813019|OG001|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
11139694|NCT01813019|EG000|Reported Event|Placebo|Matching Placebo b.i.d. dosing
11139695|NCT01813019|EG001|Reported Event|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
11139696|NCT01813058|BG000|Baseline|Placebo|"Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery.~Placebo: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to:~Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery or~TXA as previously described."
11139697|NCT01813058|BG001|Baseline|Tranexamic Acid|"Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.~Tranexamic Acid: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:~placebo i.e. saline 0.9% (intravenous injection)~intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery."
11139698|NCT01813058|BG002|Baseline|Total|Total of all reporting groups
11139699|NCT01813058|FG000|Participant Flow|Placebo|"Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery.~Placebo: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to:~Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery or~TXA as previously described."
11139700|NCT01813058|FG001|Participant Flow|Tranexamic Acid|"Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.~Tranexamic Acid: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:~placebo i.e. saline 0.9% (intravenous injection)~intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery."
11139701|NCT01813058|OG000|Outcome|Placebo|"Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery.~Placebo: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to:~Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery or~TXA as previously described."
11139702|NCT01813058|OG001|Outcome|Tranexamic Acid|"Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.~Tranexamic Acid: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:~placebo i.e. saline 0.9% (intravenous injection)~intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery."
11139703|NCT01813058|EG000|Reported Event|Placebo|"Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery.~Placebo: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to:~Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery or~TXA as previously described."
11139704|NCT01813058|EG001|Reported Event|Tranexamic Acid|"Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.~Tranexamic Acid: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:~placebo i.e. saline 0.9% (intravenous injection)~intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery."
11139705|NCT01813071|BG000|Baseline|Part A (Adults): Cohort A1|One oral dose of ~3x10^4 cfu WRSS1
11139706|NCT01813071|BG001|Baseline|Part A (Adults): Cohort A2|Three oral doses of ~3x10^5 cfu WRSS1
11139707|NCT01813071|BG002|Baseline|Part A (Adults): Cohort A3|Three oral doses of ~3x10^6 cfu WRSS1
11139708|NCT01813071|BG003|Baseline|Part A (Adults): Placebo|One or Three oral doses of Placebo
11139709|NCT01813071|BG004|Baseline|Part B (Children): Cohort B1|One oral dose of ~3x10^3 cfu WRSS1
11139710|NCT01813071|BG005|Baseline|Part B (Children): Cohort B2|Three oral doses of ~3x10^4 cfu WRSS1
11139711|NCT01813071|BG006|Baseline|Part B (Children): Cohort B3|Three oral doses of ~3x10^5 cfu WRSS1
11139712|NCT01813071|BG007|Baseline|Part B (Children): Cohort B4|Three oral doses of ~3x10^6 cfu WRSS1
11139713|NCT01813071|BG008|Baseline|Part B (Children): Placebo|One or three oral doses of Placebo
11139714|NCT01813071|BG009|Baseline|Total|Total of all reporting groups
11139715|NCT01813071|FG000|Participant Flow|Part A (Adults): Cohort A1|One oral dose of ~3x10^4 cfu WRSS1
11139716|NCT01813071|FG001|Participant Flow|Part A (Adults): Cohort A2|Three oral doses of ~3x10^5 cfu WRSS1
11139717|NCT01813071|FG002|Participant Flow|Part A (Adults): Cohort A3|Three oral doses of ~3x10^6 cfu WRSS1
11139718|NCT01813071|FG003|Participant Flow|Part A (Adults): Placebo|One or Three oral doses of Placebo
11139719|NCT01813071|FG004|Participant Flow|Part B (Children): Cohort B1|One oral dose of ~3x10^3 cfu WRSS1
11139720|NCT01813071|FG005|Participant Flow|Part B (Children): Cohort B2|Three oral doses of ~3x10^4 cfu WRSS1
11139721|NCT01813071|FG006|Participant Flow|Part B (Children): Cohort B3|Three oral doses of ~3x10^5 cfu WRSS1
11139722|NCT01813071|FG007|Participant Flow|Part B (Children): Cohort B4|Three oral doses of ~3x10^6 cfu WRSS1
11139723|NCT01813071|FG008|Participant Flow|Part B (Children): Placebo|One or three oral doses of Placebo
11139724|NCT01813071|OG000|Outcome|Part A (Adults): Cohort A1|One oral dose of ~3x10^4 cfu WRSS1
11139725|NCT01813071|OG001|Outcome|Part A (Adults): Cohort A2|Three oral doses of ~3x10^5 cfu WRSS1
11139726|NCT01813071|OG002|Outcome|Part A (Adults): Cohort A3|Three oral doses of ~3x10^6 cfu WRSS1
11139727|NCT01813071|OG003|Outcome|Part A (Adults): Placebo|One or Three oral doses of Placebo
11139728|NCT01813071|OG004|Outcome|Part B (Children): Cohort B1|One oral dose of ~3x10^3 cfu WRSS1
11139729|NCT01813071|OG005|Outcome|Part B (Children): Cohort B2|Three oral doses of ~3x10^4 cfu WRSS1
11139730|NCT01813071|OG006|Outcome|Part B (Children): Cohort B3|Three oral doses of ~3x10^5 cfu WRSS1
11139731|NCT01813071|OG007|Outcome|Part B (Children): Cohort B4|Three oral doses of ~3x10^6 cfu WRSS1
11139732|NCT01813071|OG008|Outcome|Part B (Children): Placebo|One or three oral doses of Placebo
11139733|NCT01813071|OG000|Outcome|Part A (Adults): Placebo|One or Three oral doses of Placebo
11139734|NCT01813071|OG001|Outcome|Part A (Adults): Cohort A1|One oral dose of ~3x10^4 cfu WRSS1
11139735|NCT01813071|OG002|Outcome|Part A (Adults): Cohort A2|Three oral doses of ~3x10^5 cfu WRSS1
11139736|NCT01813071|OG003|Outcome|Part A (Adults): Cohort A3|Three oral doses of ~3x10^6 cfu WRSS1
11139737|NCT01813071|OG004|Outcome|Part B (Children): Placebo|One or three oral doses of Placebo
11139738|NCT01813071|OG005|Outcome|Part B (Children): Cohort B1|One oral dose of ~3x10^3 cfu WRSS1
11139739|NCT01813071|OG006|Outcome|Part B (Children): Cohort B2|Three oral doses of ~3x10^4 cfu WRSS1
11139740|NCT01813071|OG007|Outcome|Part B (Children): Cohort B3|Three oral doses of ~3x10^5 cfu WRSS1
11139741|NCT01813071|OG008|Outcome|Part B (Children): Cohort B4|Three oral doses of ~3x10^6 cfu WRSS1
11139742|NCT01813071|OG000|Outcome|Part B (Children): Placebo|One or three oral doses of Placebo
11139743|NCT01813071|OG001|Outcome|Part B (Children): Cohort B1|One oral dose of ~3x10^3 cfu WRSS1
11139744|NCT01813071|OG002|Outcome|Part B (Children): Cohort B2|Three oral doses of ~3x10^4 cfu WRSS1
11139745|NCT01813071|OG003|Outcome|Part B (Children): Cohort B3|Three oral doses of ~3x10^5 cfu WRSS1
11139746|NCT01813071|OG004|Outcome|Part B (Children): Cohort B4|Three oral doses of ~3x10^6 cfu WRSS1
11139747|NCT01813071|EG000|Reported Event|Part A (Adults): Cohort A1|One oral dose of ~3x10^4 cfu WRSS1
11139748|NCT01813071|EG001|Reported Event|Part A (Adults): Cohort A2|Three oral doses of ~3x10^5 cfu WRSS1
11139749|NCT01813071|EG002|Reported Event|Part A (Adults): Cohort A3|Three oral doses of ~3x10^6 cfu WRSS1
11139750|NCT01813071|EG003|Reported Event|Part A (Adults): Placebo|One or Three oral doses of Placebo
11139751|NCT01813071|EG004|Reported Event|Part B (Children): Cohort B1|One oral dose of ~3x10^3 cfu WRSS1
11139752|NCT01813071|EG005|Reported Event|Part B (Children): Cohort B2|Three oral doses of ~3x10^4 cfu WRSS1
11139753|NCT01813071|EG006|Reported Event|Part B (Children): Cohort B3|Three oral doses of ~3x10^5 cfu WRSS1
11139754|NCT01813071|EG007|Reported Event|Part B (Children): Cohort B4|Three oral doses of ~3x10^6 cfu WRSS1
11139755|NCT01813071|EG008|Reported Event|Part B (Children): Placebo|One or three oral doses of Placebo
11139756|NCT01813110|BG000|Baseline|Baseline|Baseline (prior to placebo or omega-3 supplementation)
11139757|NCT01813110|FG000|Participant Flow|Placebo (8 Weeks), Then Omega-3 Fatty Acids (8 Weeks)|8 weeks of placebo (olive oil) supplementation followed by 8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate)
11139758|NCT01813110|FG001|Participant Flow|Omega-3 Fatty Acids (8 Weeks), Then Placebo (8 Weeks)|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) followed by 8 weeks of placebo (olive oil) supplementation
11139759|NCT01813110|OG000|Outcome|Placebo (8 Weeks)|8 weeks of placebo (olive oil) supplementation prior to low-dose endotoxin challenge
11139760|NCT01813110|OG001|Outcome|Omega-3 Fatty Acids (8 Weeks)|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) prior to low-dose endotoxin challenge
11139761|NCT01813110|EG000|Reported Event|Placebo, Omega-3|8 weeks of placebo (olive oil) supplementation followed by 8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate
11139762|NCT01813110|EG001|Reported Event|Omega-3, Placebo|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) followed by 8 weeks of placebo (olive oil) supplementation
11139763|NCT01813149|BG000|Baseline|CRPS I|Patients diagnosed with CRPS I.
11139764|NCT01813149|BG001|Baseline|CRPS II|"Patients diagnosed with CRPS II. Peripheral nerve injury had been verified surgically or by a confirmatory test in 14 patients with CRPS II (definite nerve lesion), whereas in another 17 patients with CRPS II, a sensory examination and quantitative sensory tests indicated sensory disturbances in an anatomically plausible nerve distribution given the site and nature of the triggering event"
11139765|NCT01813149|BG002|Baseline|Control|Pain-free subjects enrolled in the study
11139766|NCT01813149|BG003|Baseline|Total|Total of all reporting groups
11139767|NCT01813149|FG000|Participant Flow|CRPS Patients|Patients diagnosed with CRPS that were enrolled in the study. The patients in this group were scheduled to be administered phenylephrine (day 1) and clonidine (day 2) in a sequential manner.
11139768|NCT01813149|FG001|Participant Flow|Control Participants|Pain-free subjects (i.e. not diagnosed with CRPS) were enrolled in the study. These participants were not administered with phenylephrine or clonidine over the course of the study
11139769|NCT01813149|OG000|Outcome|CRPS Patients|CRPS patients who were enrolled in the study and then injected with phenylephrine
11139770|NCT01813149|OG000|Outcome|Phenylephrine Responders|CRPS-affected limbs of phenylephrine responders i.e. patients who experienced prolonged pain (>15 minutes) in the CRPS-affected limb after administration of phenylephrine
11139771|NCT01813149|OG001|Outcome|Phenylephrine Non-responders|CRPS-affected limbs of phenylephrine non-responders i.e. patients who did not experience prolonged pain in the CRPS-affected limb after administration of phenylephrine
11139772|NCT01813149|OG000|Outcome|CRPS Patients|CRPS patients who were enrolled in the study and then injected with phenylephrine (on day 1) and clonidine (on day 2)
11139773|NCT01813149|OG000|Outcome|CRPS Patients|CRPS patients who were enrolled in the study and then administered with a topical adrenoreceptor antagonist
11139774|NCT01813149|EG000|Reported Event|Phenylephrine: CRPS Patients|CRPS patients who were enrolled in the study and then administered phenylephrine (Day 1)
11139775|NCT01813149|EG001|Reported Event|Clonidine: CRPS Patients|CRPS patients who were enrolled in the study and then administered clonidine (Day 2)
11139776|NCT01813149|EG002|Reported Event|CRPS Patients|CRPS patients who were enrolled in the study but did not receive phenylephrine or clonidine.
11139777|NCT01813149|EG003|Reported Event|Control|Participants who were not diagnosed with CRPS and were not administered either phenylephrine or clonidine
11139778|NCT01813214|BG000|Baseline|Vemurafenib Monotherapy|"Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease~Vemurafenib"
11139779|NCT01813214|BG001|Baseline|Vemurafenib + Cobimetinib Combination Therapy|"Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease~Cobimetinib will be given 60mg QD for 21 days on, then 7 days off, in a 28-day treatment cycle.~Vemurafenib~Cobimetinib"
11139780|NCT01813214|BG002|Baseline|Total|Total of all reporting groups
11224559|NCT02360774|EG001|Reported Event|Canagliflozin|"Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.~Canagliflozin: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks."
11224560|NCT02360995|BG000|Baseline|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
11224561|NCT02360995|BG001|Baseline|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
11139781|NCT01813214|FG000|Participant Flow|Vemurafenib Monotherapy|"Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease~Vemurafenib"
11139782|NCT01813214|FG001|Participant Flow|Vemurafenib + Cobimetinib Combination Therapy|"Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease~Cobimetinib will be given 60mg QD for 21 days on, then 7 days off, in a 28-day treatment cycle.~Vemurafenib~Cobimetinib"
11139783|NCT01813214|OG000|Outcome|Vemurafenib Monotherapy|"Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease~Vemurafenib"
11139784|NCT01813214|OG001|Outcome|Vemurafenib + Cobimetinib Combination Therapy|"Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease~Cobimetinib will be given 60mg QD for 21 days on, then 7 days off, in a 28-day treatment cycle.~Vemurafenib~Cobimetinib"
11139785|NCT01813214|EG000|Reported Event|Vemurafenib Monotherapy|"Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease~Vemurafenib"
11139786|NCT01813214|EG001|Reported Event|Vemurafenib + Cobimetinib Combination Therapy|"Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease~Cobimetinib will be given 60mg QD for 21 days on, then 7 days off, in a 28-day treatment cycle.~Vemurafenib~Cobimetinib"
11139787|NCT01813357|BG000|Baseline|Placebo|Participants received daily placebo
11139788|NCT01813357|BG001|Baseline|Active|Participants received daily rosuvastatin
11139789|NCT01813357|BG002|Baseline|Total|Total of all reporting groups
11139790|NCT01813357|FG000|Participant Flow|Placebo|"sugar pill that is encapsulated so as to appear identical to the active agent~Placebo: Placebo arm included to maintain blinding"
11139791|NCT01813357|FG001|Participant Flow|Rosuvastatin|"Rosuvastatin 20mg daily~Rosuvastatin: encapsulated tablet 20mg daily"
11139792|NCT01813357|OG000|Outcome|Placebo|"sugar pill that is encapsulated so as to appear identical to the active agent~Placebo: Placebo arm included to maintain blinding"
11139793|NCT01813357|OG001|Outcome|Rosuvastatin|"Rosuvastatin 20mg daily~Rosuvastatin: encapsulated tablet 20mg daily"
11139794|NCT01813357|EG000|Reported Event|Placebo|"sugar pill that is encapsulated so as to appear identical to the active agent~Placebo: Placebo arm included to maintain blinding"
11139795|NCT01813357|EG001|Reported Event|Rosuvastatin|"Rosuvastatin 20mg daily~Rosuvastatin: encapsulated tablet 20mg daily"
11139796|NCT01813422|BG000|Baseline|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
11139797|NCT01813422|BG001|Baseline|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
11139798|NCT01813422|BG002|Baseline|Total|Total of all reporting groups
11139799|NCT01813422|FG000|Participant Flow|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
11139800|NCT01813422|FG001|Participant Flow|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
11139801|NCT01813422|OG000|Outcome|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
11139802|NCT01813422|OG001|Outcome|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
11139803|NCT01813422|EG000|Reported Event|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
11139804|NCT01813422|EG001|Reported Event|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
11139805|NCT01813474|BG000|Baseline|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
11139806|NCT01813474|BG001|Baseline|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
11139807|NCT01813474|BG002|Baseline|300 mg Bid, Expansion Part|Olaparib tablet 300 mg bid, 600 mg/day, expansion part
11139808|NCT01813474|BG003|Baseline|Total|Total of all reporting groups
11139809|NCT01813474|FG000|Participant Flow|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
11139810|NCT01813474|FG001|Participant Flow|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
11139811|NCT01813474|FG002|Participant Flow|300 mg Bid, Expansion Part|Olaparib tablet 300 mg bid, 600 mg/day, expansion part
11139812|NCT01813474|OG000|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
11139813|NCT01813474|OG001|Outcome|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
11139814|NCT01813474|OG002|Outcome|300 mg Bid, Expansion Part|Olaparib tablet 300 mg bid, 600 mg/day, expansion part
11139815|NCT01813474|OG001|Outcome|300 mg Bid, Dose Escalation Part|Olaparib tablet 300 mg bid, 600 mg/day, dose escalation part
11139816|NCT01813474|EG000|Reported Event|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
11139817|NCT01813474|EG001|Reported Event|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
11139818|NCT01813474|EG002|Reported Event|300 mg Bid, Expansion Part|Olaparib tablet 300 mg bid, 600 mg/day, expansion part
11139819|NCT01813721|BG000|Baseline|Primary Analysis Set|
11139820|NCT01813721|FG000|Participant Flow|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
11139821|NCT01813721|OG000|Outcome|Primary Analysis Set - Investigators|
11139822|NCT01813721|OG000|Outcome|Primary Analysis Set|
11139823|NCT01813721|OG000|Outcome|Medical Oncologist|
11139824|NCT01813721|OG000|Outcome|≤ 10 Years|
11139825|NCT01813721|OG001|Outcome|> 10 Years|
11139826|NCT01813721|OG000|Outcome|University Hospital|
11139827|NCT01813721|OG001|Outcome|General Hospital|
11139828|NCT01813721|OG000|Outcome|Poland|
11139829|NCT01813721|OG001|Outcome|Greece|
11139830|NCT01813721|OG002|Outcome|Romania|
11139831|NCT01813721|OG003|Outcome|France|
11139832|NCT01813721|OG001|Outcome|Hematologist|
11139833|NCT01813721|OG002|Outcome|Private Center|
11139834|NCT01813721|OG003|Outcome|Comprehensive Cancer Center|
11139835|NCT01813721|OG000|Outcome|Breast Cancer|
11139836|NCT01813721|OG001|Outcome|Non-small Cell Lung Cancer|
11139837|NCT01813721|OG002|Outcome|Non-Hodgkin's Lymphoma|
11139838|NCT01813721|OG003|Outcome|Small Cell Lung Cancer|
11139839|NCT01813721|OG000|Outcome|At or Above Investigator Threshold|
11139840|NCT01813721|EG000|Reported Event|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
11139841|NCT01813734|BG000|Baseline|Ponatinib Treatment Arm|"Ponatinib 30 mg PO daily~Ponatinib: 28 day cycle"
11139842|NCT01813734|FG000|Participant Flow|Ponatinib Treatment Arm|"Ponatinib 30 mg PO daily~Ponatinib: 28 day cycle"
11139843|NCT01813734|OG000|Outcome|Ponatinib Treatment Arm|"Ponatinib 30 mg PO daily~Ponatinib: 28 day cycle"
11139844|NCT01813734|EG000|Reported Event|Ponatinib Treatment Arm|"Ponatinib 30 mg PO daily~Ponatinib: 28 day cycle"
11139845|NCT01813890|BG000|Baseline|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
11139846|NCT01813890|BG001|Baseline|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
11139847|NCT01813890|BG002|Baseline|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
11139848|NCT01813890|BG003|Baseline|Total|Total of all reporting groups
11139849|NCT01813890|FG000|Participant Flow|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
11139850|NCT01813890|FG001|Participant Flow|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
11139851|NCT01813890|FG002|Participant Flow|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
11139852|NCT01813890|OG000|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
11139853|NCT01813890|OG001|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
11139854|NCT01813890|OG002|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
11139855|NCT01813890|EG000|Reported Event|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
11139856|NCT01813890|EG001|Reported Event|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
11139857|NCT01813890|EG002|Reported Event|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
11139858|NCT01814007|BG000|Baseline|Treatment Group|All study subjects are treated on the abdomen with the Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
11139859|NCT01814007|FG000|Participant Flow|Treatment Group|All study subjects are treated on the abdomen and flanks with the Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
11139860|NCT01814007|OG000|Outcome|CoolSculpting Treatment Group|"CoolSculpting of Abdomen and Flanks~The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration."
11139861|NCT01814007|OG000|Outcome|Treatment Group|All study subjects are treated on the abdomen with the Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
11139862|NCT01814007|EG000|Reported Event|CoolSculpting Treatment Group|All subjects treated with the CoolSculpting System are included in the CoolSculpting Treatment Group.
11139863|NCT01814046|BG000|Baseline|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11139864|NCT01814046|BG001|Baseline|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11139865|NCT01814046|BG002|Baseline|Total|Total of all reporting groups
11139866|NCT01814046|FG000|Participant Flow|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11139867|NCT01814046|FG001|Participant Flow|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11139868|NCT01814046|FG002|Participant Flow|Cells + High-Dose Aldesleukin Retreatment|Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
11139869|NCT01814046|OG000|Outcome|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11139870|NCT01814046|OG001|Outcome|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11139871|NCT01814046|EG000|Reported Event|Cells + High-Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11139872|NCT01814046|EG001|Reported Event|Cells and No High-Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11139873|NCT01814046|EG002|Reported Event|Cells + High-Dose Aldesleukin Retreatment|Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
11139874|NCT01814072|BG000|Baseline|1. 12 Calls, PCP|Participants received biweekly (12) coaching calls, and PCP Reports
11139875|NCT01814072|BG001|Baseline|2. 12 Calls, PCP, MR, Buddy|Participants received biweekly (12) coaching calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training.
11139876|NCT01814072|BG002|Baseline|3. 12 Calls, PCP, Texts, Buddy|Participants received 12 calls, PCP Reports, Texts, and Buddy Training
11139877|NCT01814072|BG003|Baseline|4. 12 Calls, PCP, Texts, MR|Participants received 12 calls, PCP Reports, Texts, and Meal Replacement Recommendations
11139878|NCT01814072|BG004|Baseline|5. 12 Calls, Buddy|Participants received 12 calls, and Buddy Training
11139879|NCT01814072|BG005|Baseline|6. 12 Calls, MR|Participants received 12 calls, and Meal Replacement Recommendations
11139880|NCT01814072|BG006|Baseline|7. 12 Calls, Texts|Participants received 12 calls, and Texts
11139881|NCT01814072|BG007|Baseline|8. 12 Calls, Texts, MR, Buddy|Participants received 12 calls, Texts, Meal Replacement Recommendations, and Buddy Training
11139882|NCT01814072|BG008|Baseline|9. 24 Calls, PCP|Participants received 24 calls, and PCP Reports
11139883|NCT01814072|BG009|Baseline|10. 24 Calls, PCP, MR, Buddy|Participants received 24 calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training
11009385|NCT01101477|OG000|Outcome|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11139884|NCT01814072|BG010|Baseline|11. 24 Calls, PCP, Texts, Buddy|Participants received 24 calls, PCP Reports, Texts, and Buddy Training
11139885|NCT01814072|BG011|Baseline|12. 24 Calls, PCP, Texts, MR|Participants received 24 calls, PCP Reports, Texts, and Meal Replacement Recommendations
11139886|NCT01814072|BG012|Baseline|13. 24 Calls, Buddy|Participants received 24 calls, and Buddy Training
11139887|NCT01814072|BG013|Baseline|14. 24 Calls, MR|Participants received 24 calls, and Meal Replacement Recommendations
11139888|NCT01814072|BG014|Baseline|15. 24 Calls, Texts|Participants received 24 calls, and Texts
11139889|NCT01814072|BG015|Baseline|16. 24 Calls, Texts, MR, Buddy|Participants received 24 calls, Texts, Meal Replacement Recommendations, and Buddy Training
11139890|NCT01814072|BG016|Baseline|17. 12 Calls|Participants received 12 calls
11139891|NCT01814072|BG017|Baseline|18. 12 Calls, MR, Buddy|Participants received 12 calls, Meal Replacement Recommendations, and Buddy Training
11139892|NCT01814072|BG018|Baseline|19. 12 Calls, Texts, Buddy|Participants received 12 calls, Texts, and Buddy Training
11139893|NCT01814072|BG019|Baseline|20. 12 Calls, Texts, MR|Participants received 12 calls, Texts, Meal Replacement Recommendations
11139894|NCT01814072|BG020|Baseline|21. 12 Calls, PCP, Buddy|Participants received 12 calls, PCP Reports, and Buddy Training
11139895|NCT01814072|BG021|Baseline|22. 12 Calls, PCP, MR|Participants received 12 calls, PCP Reports, and Meal Replacement Recommendations
11139896|NCT01814072|BG022|Baseline|23. 12 Calls PCP, Texts|Participants received 12 calls, PCP Reports, and Texts
11139897|NCT01814072|BG023|Baseline|24. 12 Calls, PCP, Texts, MR, Buddy|Participants received 12 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
11139898|NCT01814072|BG024|Baseline|25. 24 Calls|Participants received 24 calls
11139899|NCT01814072|BG025|Baseline|26. 24 Calls, MR, Buddy|Participants received 24 calls, Meal Replacement Recommendations, and Buddy Training
11139900|NCT01814072|BG026|Baseline|27. 24 Calls, Texts, Buddy|Participants received 24 calls, Texts, and Buddy Training
11139901|NCT01814072|BG027|Baseline|28. 24 Calls, Texts, MR|Participants received 24 calls, Texts, and Meal Replacement Recommendations
11139902|NCT01814072|BG028|Baseline|29. 24 Calls, PCP, Buddy|Participants received 24 calls, PCP Reports, and Buddy Training
11139903|NCT01814072|BG029|Baseline|30. 24 Calls, PCP, MR|Participants received 24 calls, PCP Reports, and Meal Replacement Recommendations
11139904|NCT01814072|BG030|Baseline|31. 24 Calls, PCP, Texts|Participants received 24 calls, PCP Reports, and Texts
11139905|NCT01814072|BG031|Baseline|32. 24 Calls, PCP, Texts, MR, Buddy|Participants received 24 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
11139906|NCT01814072|BG032|Baseline|Total|Total of all reporting groups
11139907|NCT01814072|FG000|Participant Flow|1. 12 Calls, PCP|Participant's received biweekly (12) coaching calls, and PCP Reports
11139908|NCT01814072|FG001|Participant Flow|2. 12 Calls, PCP, MR, Buddy|Participant's received biweekly (12) coaching calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training.
11139909|NCT01814072|FG002|Participant Flow|3. 12 Calls, PCP, Texts, Buddy|Participant received 12 calls, PCP Reports, Texts, and Buddy Training
11139910|NCT01814072|FG003|Participant Flow|4. 12 Calls, PCP, Texts, MR|Participant received 12 calls, PCP Reports, Texts, and Meal Replacement Recommendations
11139911|NCT01814072|FG004|Participant Flow|5. 12 Calls, Buddy|Participant received 12 calls, and Buddy Training
11139912|NCT01814072|FG005|Participant Flow|6. 12 Calls, MR|Participant received 12 calls, and Meal Replacement Recommendations
11139913|NCT01814072|FG006|Participant Flow|7. 12 Calls, Texts|Participant received 12 calls, and Texts
11139914|NCT01814072|FG007|Participant Flow|8. 12 Calls, Texts, MR, Buddy|Participant received 12 calls, Texts, Meal Replacement Recommendations, and Buddy Training
11139915|NCT01814072|FG008|Participant Flow|9. 24 Calls, PCP|Participants received 24 calls, and PCP Reports
11139916|NCT01814072|FG009|Participant Flow|10. 24 Calls, PCP, MR, Buddy|Participants received 24 calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training
11139917|NCT01814072|FG010|Participant Flow|11. 24 Calls, PCP, Texts, Buddy|Participants received 24 calls, PCP Reports, Texts, and Buddy Training
11139918|NCT01814072|FG011|Participant Flow|12. 24 Calls, PCP, Texts, MR|Participants received 24 calls, PCP Reports, Texts, and Meal Replacement Recommendations
11139919|NCT01814072|FG012|Participant Flow|13. 24 Calls, Buddy|Participants received 24 calls, and Buddy Training
11139920|NCT01814072|FG013|Participant Flow|14. 24 Calls, MR|Participants received 24 calls, and Meal Replacement Recommendations
11139921|NCT01814072|FG014|Participant Flow|15. 24 Calls, Texts|Participants received 24 calls, and Texts
11139922|NCT01814072|FG015|Participant Flow|16. 24 Calls, Texts, MR, Buddy|Participants received 24 calls, Texts, Meal Replacement Recommendations, and Buddy Training
11139923|NCT01814072|FG016|Participant Flow|17. 12 Calls|Participants received 12 calls
11139924|NCT01814072|FG017|Participant Flow|18. 12 Calls, MR, Buddy|Participants received 12 calls, Meal Replacement Recommendations, and Buddy Training
11139925|NCT01814072|FG018|Participant Flow|19. 12 Calls, Texts, Buddy|Participants received 12 calls, Texts, and Buddy Training
11139926|NCT01814072|FG019|Participant Flow|20. 12 Calls, Texts, MR|Participants received 12 calls, Texts, Meal Replacement Recommendations
11139927|NCT01814072|FG020|Participant Flow|21. 12 Calls, PCP, Buddy|Participants received 12 calls, PCP Reports, and Buddy Training
11139928|NCT01814072|FG021|Participant Flow|22. 12 Calls, PCP, MR|Participants received 12 calls, PCP Reports, and Meal Replacement Recommendations
11139929|NCT01814072|FG022|Participant Flow|23. 12 Calls PCP, Texts|Participants received 12 calls, PCP Reports, and Texts
11139930|NCT01814072|FG023|Participant Flow|24. 12 Calls, PCP, Texts, MR, Buddy|Participants received 12 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
11139931|NCT01814072|FG024|Participant Flow|25. 24 Calls|Participants received 24 calls
11139932|NCT01814072|FG025|Participant Flow|26. 24 Calls, MR, Buddy|Participants received 24 calls, Meal Replacement Recommendations, and Buddy Training
11224562|NCT02360995|BG002|Baseline|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
11224563|NCT02360995|BG003|Baseline|Total|Total of all reporting groups
11224564|NCT02360995|FG000|Participant Flow|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
11224565|NCT02360995|FG001|Participant Flow|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
11224566|NCT02360995|FG002|Participant Flow|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
11224567|NCT02360995|OG000|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
11224568|NCT02360995|OG001|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
11224569|NCT02360995|OG002|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
11224570|NCT02360995|EG000|Reported Event|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
11224571|NCT02360995|EG001|Reported Event|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
11224572|NCT02360995|EG002|Reported Event|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
11224573|NCT02361216|BG000|Baseline|Ingenol Mebutate Gel|"Treatment once daily for 3 days~Ingenol Mebutate"
11224574|NCT02361216|BG001|Baseline|Vehicle|"Treatment once daily for 3 days~Vehicle: Vehicle gel"
11224575|NCT02361216|BG002|Baseline|Total|Total of all reporting groups
11224576|NCT02361216|FG000|Participant Flow|Ingenol Mebutate Gel|"Treatment once daily for 3 days~Ingenol mebutate gel 0.027% or vehicle gel was applied on either the full face, full balding scalp, or within a contiguous area of approximately 250 cm2 on the chest."
11224577|NCT02361216|FG001|Participant Flow|Vehicle Gel|"Treatment once daily for 3 days~Vehicle: Vehicle gel"
11224578|NCT02361216|OG000|Outcome|Ingenol Mebutate Gel|Treatment once daily for 3 days with ingenol mebutate with 8 week follow-up after initial treatment
11224579|NCT02361216|OG001|Outcome|Vehicle|Treatment once daily for 3 days vehicle gel with 8 week follow-up after initial treatment
11224580|NCT02361216|OG000|Outcome|Ingenol Mebutate Gel|"Treatment once daily for 3 days~Ingenol Mebutate"
11224581|NCT02361216|OG001|Outcome|Vehicle|"Treatment once daily for 3 days~Vehicle: Vehicle gel"
10887433|NCT00500357|BG000|Baseline|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
11224582|NCT02361216|OG001|Outcome|Vehicle Gel|Treatment once daily for 3 days vehicle gel with 8 week follow-up after initial treatment
11224583|NCT02361216|EG000|Reported Event|Ingenol Mebutate Gel|"Treatment once daily for 3 days~Ingenol Mebutate"
11224584|NCT02361216|EG001|Reported Event|Vehicle|"Treatment once daily for 3 days~Vehicle: Vehicle gel"
11224585|NCT02361307|BG000|Baseline|Conventional ADL Training|"The control group receive the conventional ADL training programme~Conventional ADL training: The control group receive the conventional ADL training programme"
11224586|NCT02361307|BG001|Baseline|Seamless ADL Training|"The experimental group receive the seamless ADL training programme which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training.~Seamless ADL training: The experimental group receive the seamless ADL training which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training"
11224587|NCT02361307|BG002|Baseline|Total|Total of all reporting groups
11224588|NCT02361307|FG000|Participant Flow|Conventional ADL Training|The control group receive the conventional ADL training program
11224589|NCT02361307|FG001|Participant Flow|Seamless ADL Training|The experimental group receive the seamless ADL training program which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training.
11224590|NCT02361307|OG000|Outcome|Conventional ADL Training|"The control group receive the conventional ADL training program~Conventional ADL training: The control group receive the conventional ADL training program"
11139933|NCT01814072|FG026|Participant Flow|27. 24 Calls, Texts, Buddy|Participants received 24 calls, Texts, and Buddy Training
11139934|NCT01814072|FG027|Participant Flow|28. 24 Calls, Texts, MR|Participants received 24 calls, Texts, and Meal Replacement Recommendations
11139935|NCT01814072|FG028|Participant Flow|29. 24 Calls, PCP, Buddy|Participants received 24 calls, PCP Reports, and Buddy Training
11139936|NCT01814072|FG029|Participant Flow|30. 24 Calls, PCP, MR|Participants received 24 calls, PCP Reports, and Meal Replacement Recommendations
11139937|NCT01814072|FG030|Participant Flow|31. 24 Calls, PCP, Texts|Participants received 24 calls, PCP Reports, and Texts
11139938|NCT01814072|FG031|Participant Flow|32. 24 Calls, PCP, Texts, MR, Buddy|Participants received 24 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
11139939|NCT01814072|OG000|Outcome|All Reporting Groups|All participants regardless of individual randomly assigned combination of On- or Off switched levels of all intervention factors, weight measured at baseline and at Month 6.
11139940|NCT01814072|OG000|Outcome|Coaching Calls|12 bi-weekly coaching calls (Off) or 24 weekly coaching calls (On)
11139941|NCT01814072|OG001|Outcome|PCP Reports|Participant's primary care physician was (On) or was not (Off) sent a progress report after the 3 and 6 month assessments.
11139942|NCT01814072|OG002|Outcome|Text Messages|Participants either received (On) or did not receive (Off) push notifications through the app at their preferred time or when they opened the app.
11139943|NCT01814072|OG003|Outcome|Meal Replacements|Participants either received (On) or did not receive (Off) a one week supply of meal replacement bars and shakes. Those who did receive a 1-week supply of meal replacements were provided with recommendations on each coaching call to continue using these products throughout the intervention.
11139944|NCT01814072|OG004|Outcome|Buddy Training|Participant buddies either received (On) or did not receive (Off) additional training.
11139945|NCT01814072|EG000|Reported Event|Condition 1|"1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician"
11139946|NCT01814072|EG001|Reported Event|Condition 2|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139947|NCT01814072|EG002|Reported Event|Condition 3|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Text Messages: Participants will receive regular text messages~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139948|NCT01814072|EG003|Reported Event|Condition 4|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Text Messages: Participants will receive regular text messages~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements"
11139949|NCT01814072|EG004|Reported Event|Condition 5|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139950|NCT01814072|EG005|Reported Event|Condition 6|"1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements"
11139951|NCT01814072|EG006|Reported Event|Condition 7|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Text Messages: Participants will receive regular text messages"
11139952|NCT01814072|EG007|Reported Event|Condition 8|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Text Messages: Participants will receive regular text messages~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139953|NCT01814072|EG008|Reported Event|Condition 9|"1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician"
11139954|NCT01814072|EG009|Reported Event|Condition 10|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11224591|NCT02361307|OG001|Outcome|Seamless ADL Training|The experimental group receive the seamless ADL training programme which occupational therapists and nurse work with effective communication and cooperate in dressing and bathing training.
11139955|NCT01814072|EG010|Reported Event|Condition 11|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Text Messages: Participants will receive regular text messages~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139956|NCT01814072|EG011|Reported Event|Condition 12|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Text Messages: Participants will receive regular text messages~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements"
11139957|NCT01814072|EG012|Reported Event|Condition 13|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139958|NCT01814072|EG013|Reported Event|Condition 14|"1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements"
11139959|NCT01814072|EG014|Reported Event|Condition 15|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Text Messages: Participants will receive regular text messages"
11139960|NCT01814072|EG015|Reported Event|Condition 16|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Text Messages: Participants will receive regular text messages~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139961|NCT01814072|EG016|Reported Event|Condition 17|"1) Lifestyle Core; 2) 12 Telephone Coaching Sessions~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions"
11139962|NCT01814072|EG017|Reported Event|Condition 18|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139963|NCT01814072|EG018|Reported Event|Condition 19|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Text Messages: Participants will receive regular text messages~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139964|NCT01814072|EG019|Reported Event|Condition 20|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Text Messages: Participants will receive regular text messages~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements"
11139965|NCT01814072|EG020|Reported Event|Condition 21|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139966|NCT01814072|EG021|Reported Event|Condition 22|"1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician"
11139967|NCT01814072|EG022|Reported Event|Condition 23|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Text Messages: Participants will receive regular text messages"
11139968|NCT01814072|EG023|Reported Event|Condition 24|"1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars~12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Text Messages: Participants will receive regular text messages~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139969|NCT01814072|EG024|Reported Event|Condition 25|"1) Lifestyle Core; 2) 24 telephone coaching sessions~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions"
11139970|NCT01814072|EG025|Reported Event|Condition 26|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139971|NCT01814072|EG026|Reported Event|Condition 27|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Text Messages: Participants will receive regular text messages~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139972|NCT01814072|EG027|Reported Event|Condition 28|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Text Messages: Participants will receive regular text messages~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements"
11139973|NCT01814072|EG028|Reported Event|Condition 29|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139974|NCT01814072|EG029|Reported Event|Condition 30|"1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements"
11139975|NCT01814072|EG030|Reported Event|Condition 31|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Text Messages: Participants will receive regular text messages"
11139976|NCT01814072|EG031|Reported Event|Condition 32|"1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars~24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions~Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician~Text Messages: Participants will receive regular text messages~Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements~Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy"
11139977|NCT01814137|BG000|Baseline|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
11139978|NCT01814137|BG001|Baseline|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
11139979|NCT01814137|BG002|Baseline|Total|Total of all reporting groups
11139980|NCT01814137|FG000|Participant Flow|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
11139981|NCT01814137|FG001|Participant Flow|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
11224592|NCT02361307|EG000|Reported Event|Conventional ADL Training|"The control group receive the conventional ADL training programme~Conventional ADL training: The control group receive the conventional ADL training programme"
11009386|NCT01101477|OG001|Outcome|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11139982|NCT01814137|OG000|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
11139983|NCT01814137|OG001|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
11139984|NCT01814137|EG000|Reported Event|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
11139985|NCT01814137|EG001|Reported Event|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
11139986|NCT01814241|BG000|Baseline|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
11139987|NCT01814241|FG000|Participant Flow|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
11139988|NCT01814241|OG000|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
11139989|NCT01814241|OG000|Outcome|Open Label Peanut OIT|Subject cohort receiving open label orally ingested peanut flour with maintenance dose of 1450mg
11139990|NCT01814241|EG000|Reported Event|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
11139991|NCT01814332|BG000|Baseline|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
11139992|NCT01814332|BG001|Baseline|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
11139993|NCT01814332|BG002|Baseline|Total|Total of all reporting groups
11139994|NCT01814332|FG000|Participant Flow|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
11139995|NCT01814332|FG001|Participant Flow|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
11139996|NCT01814332|OG000|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
11139997|NCT01814332|OG001|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
11139998|NCT01814332|EG000|Reported Event|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
11139999|NCT01814332|EG001|Reported Event|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
11140000|NCT01814371|BG000|Baseline|Individualized Approach|"The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.~2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.~Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.~Hygiene Protocol: Follow key hygiene tips:~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.~Use liquid(pour or pump) soaps instead of bar soaps.~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.~Do not share personal care items such as razors, brushes, or deodorant.~Wash all sheets and towels in hot water. Wash sheets every week.~Use towels and wash cloths only once before washing and do not share."
11140001|NCT01814371|BG001|Baseline|Household Approach|"All members of the household will perform the decolonization regimen.~2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.~Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.~Hygiene Protocol: Follow key hygiene tips:~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.~Use liquid(pour or pump) soaps instead of bar soaps.~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.~Do not share personal care items such as razors, brushes, or deodorant.~Wash all sheets and towels in hot water. Wash sheets every week.~Use towels and wash cloths only once before washing and do not share."
11140002|NCT01814371|BG002|Baseline|Total|Total of all reporting groups
11140003|NCT01814371|FG000|Participant Flow|Individualized Approach|"The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.~2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.~Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.~Hygiene Protocol: Follow key hygiene tips:~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.~Use liquid(pour or pump) soaps instead of bar soaps.~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.~Do not share personal care items such as razors, brushes, or deodorant.~Wash all sheets and towels in hot water. Wash sheets every week.~Use towels and wash cloths only once before washing and do not share."
11140004|NCT01814371|FG001|Participant Flow|Household Approach|"All members of the household will perform the decolonization regimen.~2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.~Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.~Hygiene Protocol: Follow key hygiene tips:~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.~Use liquid(pour or pump) soaps instead of bar soaps.~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.~Do not share personal care items such as razors, brushes, or deodorant.~Wash all sheets and towels in hot water. Wash sheets every week.~Use towels and wash cloths only once before washing and do not share."
11140005|NCT01814371|OG000|Outcome|Individualized Approach|"The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.~2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.~Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.~Hygiene Protocol: Follow key hygiene tips:~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.~Use liquid(pour or pump) soaps instead of bar soaps.~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.~Do not share personal care items such as razors, brushes, or deodorant.~Wash all sheets and towels in hot water. Wash sheets every week.~Use towels and wash cloths only once before washing and do not share."
11140006|NCT01814371|OG001|Outcome|Household Approach|"All members of the household will perform the decolonization regimen.~2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.~Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.~Hygiene Protocol: Follow key hygiene tips:~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.~Use liquid(pour or pump) soaps instead of bar soaps.~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.~Do not share personal care items such as razors, brushes, or deodorant.~Wash all sheets and towels in hot water. Wash sheets every week.~Use towels and wash cloths only once before washing and do not share."
11140007|NCT01814371|OG000|Outcome|Before Decolonization|All isolates recovered across study before decolonization protocol began (enrollment visit)
11140008|NCT01814371|OG001|Outcome|After Decolonization|All isolates recovered across study directly after decolonization protocol (1 month visit)
11140009|NCT01814371|OG000|Outcome|Entire Study Population|Additional costs of associated with protocol across all participants
11140010|NCT01814371|EG000|Reported Event|Individualized Approach|"The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.~2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.~Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.~Hygiene Protocol: Follow key hygiene tips:~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.~Use liquid(pour or pump) soaps instead of bar soaps.~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.~Do not share personal care items such as razors, brushes, or deodorant.~Wash all sheets and towels in hot water. Wash sheets every week.~Use towels and wash cloths only once before washing and do not share."
11140011|NCT01814371|EG001|Reported Event|Household Approach|"All members of the household will perform the decolonization regimen.~2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.~Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.~Hygiene Protocol: Follow key hygiene tips:~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.~Use liquid(pour or pump) soaps instead of bar soaps.~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.~Do not share personal care items such as razors, brushes, or deodorant.~Wash all sheets and towels in hot water. Wash sheets every week.~Use towels and wash cloths only once before washing and do not share."
11140012|NCT01814397|BG000|Baseline|Women Starting Aromatase Inhibitor (AI) Therapy|There is only a single cohort. Postmenopausal women with estrogen receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
11140013|NCT01814397|FG000|Participant Flow|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with hormone receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
11140014|NCT01814397|OG000|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
11140015|NCT01814397|EG000|Reported Event|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
11140016|NCT01814553|BG000|Baseline|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
11140017|NCT01814553|BG001|Baseline|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
11140018|NCT01814553|BG002|Baseline|Total|Total of all reporting groups
11140019|NCT01814553|FG000|Participant Flow|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
11140020|NCT01814553|FG001|Participant Flow|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
11140021|NCT01814553|OG000|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
11140022|NCT01814553|OG001|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
11140023|NCT01814553|EG000|Reported Event|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
11140024|NCT01814553|EG001|Reported Event|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
11140025|NCT01814670|BG000|Baseline|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
11140026|NCT01814670|FG000|Participant Flow|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
11140027|NCT01814670|OG000|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
11140028|NCT01814670|EG000|Reported Event|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
11140029|NCT01814696|BG000|Baseline|Control|Subjects will continue to receive usual medical care from their doctor(s).
11140030|NCT01814696|BG001|Baseline|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
11140031|NCT01814696|BG002|Baseline|Total|Total of all reporting groups
11140032|NCT01814696|FG000|Participant Flow|Control|"Subjects will continue to receive usual medical care from their doctor(s).~Subjects will follow their normal medication management routine."
11140033|NCT01814696|FG001|Participant Flow|Intervention|"Subjects will continue to receive usual medical care from their doctor(s).~Intervention: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
11140034|NCT01814696|OG000|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
11140035|NCT01814696|OG001|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
11140036|NCT01814696|EG000|Reported Event|Control|Subjects will continue to receive usual medical care from their doctor(s).
11140037|NCT01814696|EG001|Reported Event|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
11140038|NCT01814748|BG000|Baseline|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
11140039|NCT01814748|BG001|Baseline|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
11140040|NCT01814748|BG002|Baseline|Total|Total of all reporting groups
11140041|NCT01814748|FG000|Participant Flow|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
11140042|NCT01814748|FG001|Participant Flow|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
11140043|NCT01814748|OG000|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
11140044|NCT01814748|OG001|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
11140045|NCT01814748|EG000|Reported Event|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
11140046|NCT01814748|EG001|Reported Event|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
11140047|NCT01814761|BG000|Baseline|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
11140048|NCT01814761|BG001|Baseline|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
11140049|NCT01814761|BG002|Baseline|Total|Total of all reporting groups
11140050|NCT01814761|FG000|Participant Flow|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
11140051|NCT01814761|FG001|Participant Flow|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
11140052|NCT01814761|OG000|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
11140053|NCT01814761|OG001|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
11140054|NCT01814761|EG000|Reported Event|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
11140055|NCT01814761|EG001|Reported Event|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
11140056|NCT01814774|BG000|Baseline|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
11140057|NCT01814774|FG000|Participant Flow|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
11140058|NCT01814774|OG000|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
11140059|NCT01814774|OG001|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
11140060|NCT01814774|EG000|Reported Event|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
11140061|NCT01814774|EG001|Reported Event|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
11140062|NCT01814787|BG000|Baseline|CHICA Type 2 Diabetes Module|"Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.~CHICA Type 2 Diabetes Module: Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system."
11140063|NCT01814787|BG001|Baseline|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child's BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
11140064|NCT01814787|BG002|Baseline|Total|Total of all reporting groups
11140065|NCT01814787|FG000|Participant Flow|CHICA Type 2 Diabetes Module|"Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.~CHICA Type 2 Diabetes Module: Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system. If the child's BMI > 85th percentile, a prompt will appear on the provider worksheet asking the clinician"
11140066|NCT01814787|FG001|Participant Flow|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child's BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
11140067|NCT01814787|OG000|Outcome|CHICA Type 2 Diabetes Module|Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
11140068|NCT01814787|OG001|Outcome|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child's BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
11140069|NCT01814787|EG000|Reported Event|CHICA Type 2 Diabetes Module|Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
11224593|NCT02361307|EG001|Reported Event|Seamless ADL Training|"The experimental group receive the seamless ADL training programme which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training.~Seamless ADL training: The experimental group receive the seamless ADL training which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training"
11224594|NCT02361476|BG000|Baseline|Intervention|"Clonidine : injection og 3 micg/kg IV during the operation.~Clonidine: Injection - during surgery"
11224595|NCT02361476|BG001|Baseline|Placebo|"Placebo : injection og equal amount of NaCl IV during the operation.~Placebo: Injection - during surgery"
11224596|NCT02361476|BG002|Baseline|Total|Total of all reporting groups
11224597|NCT02361476|FG000|Participant Flow|Intervention|"Clonidine : injection og 3 micg/kg IV during the operation.~Clonidine: Injection - during surgery"
11224598|NCT02361476|FG001|Participant Flow|Placebo|"Placebo : injection og equal amount of NaCl IV during the operation.~Placebo: Injection - during surgery"
11140070|NCT01814787|EG001|Reported Event|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child's BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
11140071|NCT01814800|BG000|Baseline|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
11140072|NCT01814800|FG000|Participant Flow|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg IV infusion Frequency: Every 3 or 4 weeks~Initial dose selection based on prior IGIV regimen, doses adjusted during study to maintain trough Immunoglobulin G (IgG) concentration of 500 mg/dL or greater according to investigator decision."
11140073|NCT01814800|OG000|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
11140074|NCT01814800|EG000|Reported Event|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
11140075|NCT01814813|BG000|Baseline|Arm 1, HSPPC-96 + Concomitant Bevacizumab|HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous
11140076|NCT01814813|BG001|Baseline|Arm 2, HSPPC-96 With Bevacizumab at Progression|HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days) NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous
11140077|NCT01814813|BG002|Baseline|Arm 3, Bevacizumab|Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
11140078|NCT01814813|BG003|Baseline|Total|Total of all reporting groups
11140079|NCT01814813|FG000|Participant Flow|Arm 1, HSPPC-96 + Concomitant Bevacizumab|HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous
11009387|NCT01101477|OG002|Outcome|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11140080|NCT01814813|FG001|Participant Flow|Arm 2, HSPPC-96 With Bevacizumab at Progression|"HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days)>~> NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous"
11140081|NCT01814813|FG002|Participant Flow|Arm 3, Bevacizumab|Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
11140082|NCT01814813|OG000|Outcome|Arm 1, HSPPC-96 + Concomitant Bevacizumab|HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous
11140083|NCT01814813|OG001|Outcome|Arm 2, HSPPC-96 With Bevacizumab at Progression|"HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days)>~> NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous"
11140084|NCT01814813|OG002|Outcome|Arm 3, Bevacizumab|Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
11140085|NCT01814813|EG000|Reported Event|Arm 1, HSPPC-96 + Concomitant Bevacizumab|HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous
11224599|NCT02361476|OG000|Outcome|Intervention|"Clonidine : injection og 3 micg/kg IV during the operation.~Clonidine: Injection - during surgery"
11224600|NCT02361476|OG001|Outcome|Placebo|"Placebo : injection og equal amount of NaCl IV during the operation.~Placebo: Injection - during surgery"
11140086|NCT01814813|EG001|Reported Event|Arm 2, HSPPC-96 With Bevacizumab at Progression|HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days) NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous
11140087|NCT01814813|EG002|Reported Event|Arm 3, Bevacizumab|Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
11140088|NCT01814878|BG000|Baseline|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
11140089|NCT01814878|BG001|Baseline|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
11140090|NCT01814878|BG002|Baseline|Total|Total of all reporting groups
11140091|NCT01814878|FG000|Participant Flow|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
11140092|NCT01814878|FG001|Participant Flow|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
11140093|NCT01814878|OG000|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
11140094|NCT01814878|OG001|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
11140095|NCT01814878|EG000|Reported Event|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
11140096|NCT01814878|EG001|Reported Event|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
11140097|NCT01815008|BG000|Baseline|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
11140098|NCT01815008|FG000|Participant Flow|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
11140099|NCT01815008|OG000|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
11140100|NCT01815008|OG000|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
11140101|NCT01815008|OG000|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily~Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
11140102|NCT01815008|EG000|Reported Event|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
11140103|NCT01815099|BG000|Baseline|rTMS Treatment|rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
11140104|NCT01815099|FG000|Participant Flow|rTMS Treatment|This was an open trial. All participants received active rTMS
11140105|NCT01815099|OG000|Outcome|Pre rTMS Treatment|Assessment before beginning rTMS treatment
11140106|NCT01815099|OG001|Outcome|Post rTMS Treatment|Assessment After Completing rTMS
11140107|NCT01815099|EG000|Reported Event|rTMS Treatment|rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
11140108|NCT01815138|BG000|Baseline|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
11140109|NCT01815138|BG001|Baseline|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
11140110|NCT01815138|BG002|Baseline|Total|Total of all reporting groups
11140111|NCT01815138|FG000|Participant Flow|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
11140112|NCT01815138|FG001|Participant Flow|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
11140113|NCT01815138|OG000|Outcome|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
11140114|NCT01815138|OG001|Outcome|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
11140115|NCT01815138|EG000|Reported Event|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
11140116|NCT01815138|EG001|Reported Event|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
11140117|NCT01815229|BG000|Baseline|Tracheal Lavages Sore Throat|"After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.~A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.~tracheal lavages: tracheal lavages obtained during endotracheal intubation."
11140118|NCT01815229|BG001|Baseline|Tracheal Lavages No Sore Throat|"After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.~A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes."
11140119|NCT01815229|BG002|Baseline|Healthy Control|To replicate activation, neutrophils were isolated from 20mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain.
11140120|NCT01815229|BG003|Baseline|Total|Total of all reporting groups
11009388|NCT01101477|EG000|Reported Event|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11140121|NCT01815229|FG000|Participant Flow|Tracheal Lavages Sore Throat|"After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.~A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.~tracheal lavages: tracheal lavages obtained during endotracheal intubation."
11140122|NCT01815229|FG001|Participant Flow|Tracheal Lavages No Sore Throat|"After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.~A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.~tracheal lavages: tracheal lavages obtained during endotracheal intubation."
11140123|NCT01815229|FG002|Participant Flow|Healthy Control|A one time blood sample of approx 30cc will be collected by venipuncture.
11140124|NCT01815229|OG000|Outcome|Tracheal Lavages Sore Throat|"After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.~A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.~tracheal lavages: tracheal lavages obtained during endotracheal intubation."
11140125|NCT01815229|OG001|Outcome|Tracheal Lavage no Sore Throat|"After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.~A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.~tracheal lavages: tracheal lavages obtained during endotracheal intubation."
11140126|NCT01815229|EG000|Reported Event|Tracheal Lavages Sore Throat|"After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.~A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.~tracheal lavages: tracheal lavages obtained during endotracheal intubation."
11140127|NCT01815229|EG001|Reported Event|Tracheal Lavages No Sore Throat|"After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.~A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes."
11140128|NCT01815229|EG002|Reported Event|Healthy Control|To replicate activation, neutrophils were isolated from 20mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain.
11224601|NCT02361476|EG000|Reported Event|Intervention|"Clonidine : injection og 3 micg/kg IV during the operation.~Clonidine: Injection - during surgery"
11140129|NCT01815333|BG000|Baseline|Feraheme|"Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational.~Feraheme: 6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI.~Magnetic Resonance Imaging (MRI): MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day."
11140130|NCT01815333|FG000|Participant Flow|Feraheme|"Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational.~Feraheme: 6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI.~Magnetic Resonance Imaging (MRI): MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day."
11140131|NCT01815333|OG000|Outcome|Feraheme|"Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational.~Feraheme: 6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI.~Magnetic Resonance Imaging (MRI): MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day."
11140132|NCT01815333|EG000|Reported Event|Feraheme|"Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational.~Feraheme: 6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI.~Magnetic Resonance Imaging (MRI): MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day."
11140133|NCT01815424|BG000|Baseline|Tofacitinib 10 mg|Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
11140134|NCT01815424|BG001|Baseline|Tofacitinib 5 mg|Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
11140135|NCT01815424|BG002|Baseline|Placebo|Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
11140136|NCT01815424|BG003|Baseline|Total|Total of all reporting groups
11140137|NCT01815424|FG000|Participant Flow|Tofacitinib 10 mg|Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
11140138|NCT01815424|FG001|Participant Flow|Tofacitinib 5 mg|Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
11140139|NCT01815424|FG002|Participant Flow|Placebo|Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
11140140|NCT01815424|FG003|Participant Flow|Placebo to Tofacitinib 10 mg|Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
11140141|NCT01815424|FG004|Participant Flow|Placebo to Tofacitinib 5 mg|Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
11140142|NCT01815424|OG000|Outcome|Tofacitinib 10 mg|Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
11140143|NCT01815424|OG001|Outcome|Tofacitinib 5 mg|Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
11140144|NCT01815424|OG002|Outcome|Placebo|Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
11140145|NCT01815424|OG002|Outcome|Placebo to Tofacitinib 10 mg|Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
11140146|NCT01815424|OG003|Outcome|Placebo to Tofacitinib 5 mg|Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
11140147|NCT01815424|OG000|Outcome|Tofacitinib 10 mg|Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 0hours apart) up to Week 52.
11140148|NCT01815424|EG000|Reported Event|Tofacitinib 10 mg|Participants received tofacitinib 10 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
11140149|NCT01815424|EG001|Reported Event|Tofacitinib 5 mg|Participants received tofacitinib 5 mg tablet orally twice daily (approximately 12 hours apart) up to Week 52.
11140150|NCT01815424|EG002|Reported Event|Placebo to Tofacitinib 10 mg|Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 10 mg twice daily up to Week 52.
11140151|NCT01815424|EG003|Reported Event|Placebo to Tofacitinib 5 mg|Participants received placebo tablet orally twice daily until Week 16, followed by tofacitinib 5 mg twice daily up to Week 52.
11140152|NCT01815424|EG004|Reported Event|Placebo|Participants received placebo tablets orally twice daily up to Week 16. At Week 16, participants in this group were automatically advanced to their second treatment of tofacitinib 5 mg or 10 mg tablet orally twice daily, which was pre-determined at randomization (44 participants assigned to Placebo to 5 mg, 44 participants assigned to Placebo to 10 mg).
11224602|NCT02361476|EG001|Reported Event|Placebo|"Placebo : injection og equal amount of NaCl IV during the operation.~Placebo: Injection - during surgery"
11140153|NCT01815502|BG000|Baseline|Sildenafil|"Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140154|NCT01815502|BG001|Baseline|Sugar Pill|"Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140155|NCT01815502|BG002|Baseline|Total|Total of all reporting groups
11140156|NCT01815502|FG000|Participant Flow|Sildenafil|"Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140157|NCT01815502|FG001|Participant Flow|Sugar Pill|"Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140158|NCT01815502|OG000|Outcome|Sildenafil|"Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140159|NCT01815502|OG001|Outcome|Sugar Pill|"Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes.~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140160|NCT01815502|OG001|Outcome|Sugar Pill|"Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140161|NCT01815502|OG000|Outcome|Dobutamine + Sildenafil|"Sildenafil will be given an one time dose 30 to 90 minutes prior to cardiac catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Cardiac catheterization: All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization."
11140162|NCT01815502|OG001|Outcome|Dobutamine + Placebo|"Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to cardiac catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Cardiac catheterization: All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization."
11140163|NCT01815502|EG000|Reported Event|Sildenafil|"Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140164|NCT01815502|EG001|Reported Event|Sugar Pill|"Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..~Dobutamine: Patients will receive a dobutamine infusion during catheterization."
11140165|NCT01815515|BG000|Baseline|18F-DCFBC|Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
11140166|NCT01815515|FG000|Participant Flow|18F-DCFBC|Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
11140167|NCT01815515|OG000|Outcome|18F-DCFBC|Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
11140168|NCT01815515|EG000|Reported Event|18F-DCFBC|18F-DCFBC
11140169|NCT01815645|BG000|Baseline|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
11140170|NCT01815645|BG001|Baseline|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
11140171|NCT01815645|BG002|Baseline|Total|Total of all reporting groups
11140172|NCT01815645|FG000|Participant Flow|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
11140173|NCT01815645|FG001|Participant Flow|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
11140174|NCT01815645|OG000|Outcome|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
11140175|NCT01815645|OG001|Outcome|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
11140176|NCT01815645|OG000|Outcome|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
11140177|NCT01815645|OG001|Outcome|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
11140178|NCT01815645|EG000|Reported Event|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
11140179|NCT01815645|EG001|Reported Event|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
11140180|NCT01815671|BG000|Baseline|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
11140181|NCT01815671|BG001|Baseline|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
11009389|NCT01101477|EG001|Reported Event|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11140182|NCT01815671|BG002|Baseline|Total|Total of all reporting groups
11140183|NCT01815671|FG000|Participant Flow|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
11140184|NCT01815671|FG001|Participant Flow|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
11140185|NCT01815671|OG000|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
11140186|NCT01815671|OG001|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
11140187|NCT01815671|EG000|Reported Event|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
11140188|NCT01815671|EG001|Reported Event|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
11140189|NCT01815736|BG000|Baseline|E/C/F/TAF|"Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF)(150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks.~Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF."
11140190|NCT01815736|BG001|Baseline|Stay on Baseline Treatment Regimen (SBR)|"Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks.~Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF."
11140191|NCT01815736|BG002|Baseline|Total|Total of all reporting groups
11140192|NCT01815736|FG000|Participant Flow|E/C/F/TAF|"Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks.~Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF."
11140193|NCT01815736|FG001|Participant Flow|Stay on Baseline Treatment Regimen (SBR)|"Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks.~Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF."
11140194|NCT01815736|OG000|Outcome|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
11140195|NCT01815736|OG001|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
11224603|NCT02361736|BG000|Baseline|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
11140196|NCT01815736|EG000|Reported Event|Randomized Phase: E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; EVG/COBI/FTC/TAF; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
11140197|NCT01815736|EG001|Reported Event|Randomized Phase: Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline emtricitabine(FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
11140198|NCT01815736|EG002|Reported Event|Extension Phase: E/C/F/TAF From E/C/F/TAF|After completing 96 weeks of randomized treatment (E/C/F/TAF), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
11140199|NCT01815736|EG003|Reported Event|Extension Phase: E/C/F/TAF From SBR|After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
11140200|NCT01815840|BG000|Baseline|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
11140201|NCT01815840|BG001|Baseline|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
11140202|NCT01815840|BG002|Baseline|Total|Total of all reporting groups
11140203|NCT01815840|FG000|Participant Flow|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
11140204|NCT01815840|FG001|Participant Flow|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
11140205|NCT01815840|OG000|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
11140206|NCT01815840|OG001|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
11140207|NCT01815840|EG000|Reported Event|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
11140208|NCT01815840|EG001|Reported Event|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
11140209|NCT01815918|BG000|Baseline|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
11140210|NCT01815918|BG001|Baseline|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
11140211|NCT01815918|BG002|Baseline|Total|Total of all reporting groups
11140212|NCT01815918|FG000|Participant Flow|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
11140213|NCT01815918|FG001|Participant Flow|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
11140214|NCT01815918|OG000|Outcome|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
11140215|NCT01815918|OG001|Outcome|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
11140216|NCT01815918|OG000|Outcome|Placebo|
11140217|NCT01815918|OG001|Outcome|Treatment|
11140218|NCT01815918|OG000|Outcome|Placebo|Data was not collected
11140219|NCT01815918|OG001|Outcome|Treatment|Data was not collected
11140220|NCT01815918|EG000|Reported Event|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
11140221|NCT01815918|EG001|Reported Event|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
11140222|NCT01816048|BG000|Baseline|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
11140223|NCT01816048|FG000|Participant Flow|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
11140224|NCT01816048|OG000|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
11140225|NCT01816048|OG000|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
11140226|NCT01816048|EG000|Reported Event|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
11140227|NCT01816061|BG000|Baseline|Experimental - COMPASS|"The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.~Experimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks."
11140228|NCT01816061|BG001|Baseline|Control - COMMPASS|"Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.~Control~Control - COMPASS: Increased hours of patient-provider interactions Group."
11140229|NCT01816061|BG002|Baseline|Total|Total of all reporting groups
11140230|NCT01816061|FG000|Participant Flow|Arm 1: Experimental|"The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.~Experimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks."
11140231|NCT01816061|FG001|Participant Flow|Arm 1: Control|"Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.~Control~Control - COMPASS: Increased hours of patient-provider interactions Group."
11140232|NCT01816061|OG000|Outcome|Arm 1: Experimental|"The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.~Experimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks."
11140233|NCT01816061|OG001|Outcome|Arm 1: Control|"Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.~Control~Control - COMPASS: Increased hours of patient-provider interactions Group."
11348795|NCT04147611|EG000|Reported Event|Remote Microphone (RM) Technology Group|"The RM technology group will limited to the pediatrics participants.~Participants will be tested separately on the three following conditions:~Bone Conduction Device (BAHA) only~BAHA + Wireless Audio-Streaming Accessory~BAHA + Digital Adaptive RM System~BAHA: Participant's pediatric bone conduction hearing device.~Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.~Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid."
11140234|NCT01816061|EG000|Reported Event|Arm 1: Experimental|"The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.~Experimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks."
11140235|NCT01816061|EG001|Reported Event|Arm 1: Control|"Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.~Control~Control - COMPASS: Increased hours of patient-provider interactions Group."
11140236|NCT01816074|BG000|Baseline|Maternal Medication Then Meds|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
11140237|NCT01816074|BG001|Baseline|BPT Then Continued Beh tx|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140238|NCT01816074|BG002|Baseline|Maternal Medication Then BPT|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140239|NCT01816074|BG003|Baseline|BPT Then Maternal Medication|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140240|NCT01816074|BG004|Baseline|Total|Total of all reporting groups
11140241|NCT01816074|FG000|Participant Flow|Maternal Medication Then Additional Maternal Medication|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
11140242|NCT01816074|FG001|Participant Flow|Maternal Behavioral Parent Training (BPT) Then Additional BPT|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140243|NCT01816074|FG002|Participant Flow|Maternal Medication Then BPT|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140244|NCT01816074|FG003|Participant Flow|BPT Then Maternal Medication|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140245|NCT01816074|OG000|Outcome|Maternal Medication Then Additional Maternal Medication|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
11140246|NCT01816074|OG001|Outcome|Maternal Behavioral Parent Training (BPT) Then Additional BPT|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140247|NCT01816074|OG002|Outcome|Maternal Medication Then BPT|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140248|NCT01816074|OG003|Outcome|BPT Then Maternal Medication|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140249|NCT01816074|OG000|Outcome|Maternal Medication Then Additional Maternal Med - Baseline|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
11140250|NCT01816074|OG001|Outcome|Maternal Medication Then Additional Maternal Med - Week 8|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
11140251|NCT01816074|OG002|Outcome|Maternal Medication Then Additional Maternal Med - Week 16|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
11140252|NCT01816074|OG003|Outcome|Maternal Medication Then Behavior Parent Training - Baseline|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140253|NCT01816074|OG004|Outcome|Maternal Medication Then Behavior Parent Training - Week 8|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140254|NCT01816074|OG005|Outcome|Maternal Medication Then Behavior Parent Training - Week 16|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140255|NCT01816074|OG006|Outcome|Behavior Parent Training Then Maternal Medication - Baseline|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140256|NCT01816074|OG007|Outcome|Behavior Parent Training Then Maternal Medication - Week 8|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140257|NCT01816074|OG008|Outcome|Behavior Parent Training Then Maternal Medication - Week 16|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140258|NCT01816074|OG009|Outcome|Behavior Parent Training Then Additional BPT - Baseline|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140259|NCT01816074|OG010|Outcome|Behavior Parent Training Then Additional BPT - Week 8|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140260|NCT01816074|OG011|Outcome|Behavior Parent Training Then Additional BPT - Week 16|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
11140261|NCT01816074|EG000|Reported Event|Vyvanse 20 mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 20mg was the first dose they received.
11140262|NCT01816074|EG001|Reported Event|Vyvanse 30 mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 30mg was offered to the mother if 20mg was not a strong enough dose.
11140263|NCT01816074|EG002|Reported Event|Vyvanse 40mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 40mg was offered to the mother if 30mg was not a strong enough dose.
11140264|NCT01816074|EG003|Reported Event|Vyvanse 50 mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 50mg was offered to the mother if 40mg was not a strong enough dose.
11140265|NCT01816074|EG004|Reported Event|Vyvanse 60 mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 60mg was offered to the mother if 50mg was not a strong enough dose.
11140266|NCT01816074|EG005|Reported Event|Vyvanse 70mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 70mg was offered to the mother if 60mg was not a strong enough dose.
11140267|NCT01816230|BG000|Baseline|NiCord®|"NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic umbilical cord blood (UCB) cells.~NiCord®"
11140268|NCT01816230|FG000|Participant Flow|NiCord®|"NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells.~NiCord®"
11140269|NCT01816230|OG000|Outcome|NiCord®|"NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells.~NiCord®"
11140270|NCT01816230|EG000|Reported Event|NiCord®|"NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells.~NiCord®"
11140271|NCT01816243|BG000|Baseline|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
11140272|NCT01816243|FG000|Participant Flow|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
11140273|NCT01816243|OG000|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
11140274|NCT01816243|EG000|Reported Event|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
11140275|NCT01816295|BG000|Baseline|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
11140276|NCT01816295|BG001|Baseline|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
11140277|NCT01816295|BG002|Baseline|Total|Total of all reporting groups
11140278|NCT01816295|FG000|Participant Flow|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
11140279|NCT01816295|FG001|Participant Flow|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
11140280|NCT01816295|OG000|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
11140281|NCT01816295|OG001|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
11140282|NCT01816295|EG000|Reported Event|Placebo Solution - Double Blind|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.
11140283|NCT01816295|EG001|Reported Event|Testosterone Solution - Double Blind|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period.
11140284|NCT01816295|EG002|Reported Event|Testosterone Solution - OLE|Sixty mg testosterone solution applied topically to axillae once daily at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks in optional OLE period.
11140285|NCT01816451|BG000|Baseline|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
11140286|NCT01816451|BG001|Baseline|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
11140287|NCT01816451|BG002|Baseline|Control|The control group did not do the running training program. Control did their normal physical activities.
11140288|NCT01816451|BG003|Baseline|Total|Total of all reporting groups
11140289|NCT01816451|FG000|Participant Flow|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
11140290|NCT01816451|FG001|Participant Flow|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
11140291|NCT01816451|FG002|Participant Flow|Control|The control group did not do the running training program. Control did their normal physical activities.
11140292|NCT01816451|OG000|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
11140293|NCT01816451|OG001|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine.The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
11140294|NCT01816451|OG002|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
11140295|NCT01816451|OG000|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
11140296|NCT01816451|OG001|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
11140297|NCT01816451|EG000|Reported Event|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
11140298|NCT01816451|EG001|Reported Event|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
11140299|NCT01816451|EG002|Reported Event|Control|The control group did not do the running training program. Control did their normal physical activities.
11140300|NCT01816477|BG000|Baseline|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
11140301|NCT01816477|BG001|Baseline|ON-Q Soaker Catheter System|"ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5 catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia."
11140302|NCT01816477|BG002|Baseline|Total|Total of all reporting groups
11140303|NCT01816477|FG000|Participant Flow|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
11140304|NCT01816477|FG001|Participant Flow|ON-Q Soaker Catheter System|"ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5 catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia."
11140305|NCT01816477|OG000|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
11140306|NCT01816477|OG001|Outcome|ON-Q Soaker Catheter System|"ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5 catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia."
11140307|NCT01816477|EG000|Reported Event|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
11140308|NCT01816477|EG001|Reported Event|ON-Q Soaker Catheter System|"ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5 catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia."
11140309|NCT01816594|BG000|Baseline|Trastuzumab + BKM120 + Paclitaxel|BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.
11140310|NCT01816594|BG001|Baseline|Trastuzumab + BKM120 PBO + Paclitaxel|BKM120 placebo in combination with trastuzumab and paclitaxel
11140311|NCT01816594|BG002|Baseline|Total|Total of all reporting groups
11140312|NCT01816594|FG000|Participant Flow|Trastuzumab + BKM120 + Paclitaxel|BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.
11140313|NCT01816594|FG001|Participant Flow|Trastuzumab + BKM120 PBO + Paclitaxel|BKM120 placebo in combination with trastuzumab and paclitaxel
11140314|NCT01816594|OG000|Outcome|Trastuzumab + BKM120 + Paclitaxel|BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.
11140315|NCT01816594|OG001|Outcome|Trastuzumab + BKM120 PBO + Paclitaxel|BKM120 placebo in combination with trastuzumab and paclitaxel
11140316|NCT01816594|OG000|Outcome|Trastuzumab + BKM120 + Paclitaxel ( ER+)|BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel in positive estrogen receptor participants.
11140317|NCT01816594|OG001|Outcome|Trastuzumab + BKM120 PBO + Paclitaxel (ER+)|BKM120 placebo in combination with trastuzumab and paclitaxel in patients with positive estrogen receptor participants
11140318|NCT01816594|OG000|Outcome|Trastuzumab + BKM120 + Paclitaxel (ER-)|BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel in negative estrogen receptor participants.
11140319|NCT01816594|OG001|Outcome|Trastuzumab + BKM120 PBO + Paclitaxel (ER-)|BKM120 placebo in combination with trastuzumab and paclitaxel in negative estrogen receptor participants
11140320|NCT01816594|OG000|Outcome|Trastuzumab + BKM120 + Paclitaxel (ER+)|BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel in positive estrogen receptor participants.
11140321|NCT01816594|OG001|Outcome|Trastuzumab + BKM120 PBO + Paclitaxel (ER+)|BKM120 placebo in combination with trastuzumab and paclitaxel in positive estrogen receptor participants
11140322|NCT01816594|EG000|Reported Event|Trastuzumab + BKM120 + Paclitaxel|BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel.
11140323|NCT01816594|EG001|Reported Event|Trastuzumab + BKM120 PBO + Paclitaxel|BKM120 placebo in combination with trastuzumab and paclitaxel
11140324|NCT01816685|BG000|Baseline|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
11140325|NCT01816685|BG001|Baseline|Routine Care|Routine care will be provided to the participant.
11140326|NCT01816685|BG002|Baseline|Total|Total of all reporting groups
11140327|NCT01816685|FG000|Participant Flow|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
11140328|NCT01816685|FG001|Participant Flow|Routine Care|Routine care will be provided to the participant.
11140329|NCT01816685|OG000|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
11140330|NCT01816685|OG001|Outcome|Routine Care|Routine care will be provided to the participant.
11140331|NCT01816685|EG000|Reported Event|CPAP|"Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.~CPAP"
11140332|NCT01816685|EG001|Reported Event|Routine Care|Routine care will be provided to the participant.
11140333|NCT01816711|BG000|Baseline|Hip Fracture, Frail Elderly, Non-supplemented|Frail elderly with a hip fracture who did not receive vitamin D supplementation
11140334|NCT01816711|BG001|Baseline|Hip Fracture, Frail Elderly, Supplemented|Frail elderly with a hip fracture who received vitamin D supplementation
11140335|NCT01816711|BG002|Baseline|Total|Total of all reporting groups
11140336|NCT01816711|FG000|Participant Flow|Hip Fracture, Frail Elderly, Non-supplemented|Cases: Frail elderly with a hip fracture who did not receive vitamin D supplementation
11140337|NCT01816711|FG001|Participant Flow|Hip Fracture, Frail Elderly, Supplemented|Frail elderly with a hip fracture who received vitamin D supplementation
11140338|NCT01816711|OG000|Outcome|Hip Fracture, Frail Elderly, Non-supplemented|Frail elderly with a hip fracture who did not received vitamin D supplementation
11140339|NCT01816711|OG001|Outcome|Hip Fracture, Frail Elderly, Supplemented|Frail elderly with a hip fracture who received vitamin D supplementation
11140340|NCT01816711|EG000|Reported Event|Hip Fracture, Frail Elderly, Non-supplemented|Frail elderly with a hip fracture who did not receive vitamin D supplementation
11140341|NCT01816711|EG001|Reported Event|Hip Fracture, Frail Elderly, Supplemented|Frail elderly with a hip fracture who received vitamin D supplementation
11140342|NCT01816763|BG000|Baseline|Tablet Based NRS Pain Now, Followed by Nurse Pain Screen|"tablet-based patient self-report of the 'NRS pain now'~NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener."
11140343|NCT01816763|BG001|Baseline|Tablet Based PEG, Followed by Nurse Pain Screen|"tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)~PEG: Eligible patients will be assigned to complete a patient-reported enhanced pain screening with the PEG on a tablet prior to making contact with a nursing staff vital signs screener."
11140344|NCT01816763|BG002|Baseline|DVPRS, Followed by Nurse Pain Screen|"Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now~DVPRS: Eligible patients will be randomly assigned to complete a patient-reported 'DVPRS' on a tablet prior to making contact with a nursing staff vital signs screener."
11140345|NCT01816763|BG003|Baseline|Total|Total of all reporting groups
11140346|NCT01816763|FG000|Participant Flow|Tablet Based NRS Pain Now, Followed by Nurse Pain Screen|"tablet-based patient self-report of the 'NRS pain now'~NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener."
11140347|NCT01816763|FG001|Participant Flow|Tablet Based PEG, Followed by Nurse Pain Screen|"tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)~PEG: Eligible patients will be assigned to complete a patient-reported enhanced pain screening with the PEG on a tablet prior to making contact with a nursing staff vital signs screener."
11140348|NCT01816763|FG002|Participant Flow|DVPRS, Followed by Nurse Pain Screen|"Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now~DVPRS: Eligible patients will be randomly assigned to complete a patient-reported 'DVPRS' on a tablet prior to making contact with a nursing staff vital signs screener."
11140349|NCT01816763|OG000|Outcome|Tablet Based NRS Pain Now|"tablet-based patient self-report of the 'NRS pain now'~NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener."
11140350|NCT01816763|OG001|Outcome|Tablet Based PEG|"tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)~PEG: Eligible patients will be assigned to complete a patient-reported enhanced pain screening with the PEG on a tablet prior to making contact with a nursing staff vital signs screener."
11140351|NCT01816763|OG002|Outcome|DVPRS|"Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now~DVPRS: Eligible patients will be randomly assigned to complete a patient-reported 'DVPRS' on a tablet prior to making contact with a nursing staff vital signs screener."
11140352|NCT01816763|OG000|Outcome|Tablet-based NRS Pain Now|tablet-based patient self-report of the 'NRS pain now'
11140353|NCT01816763|OG001|Outcome|Tablet-based PEG|tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)
11140354|NCT01816763|OG002|Outcome|DVPRS|Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now
11140355|NCT01816763|EG000|Reported Event|Tablet Based NRS Pain Now, Followed by Nurse Pain Screen|"tablet-based patient self-report of the 'NRS pain now'~NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener."
11140356|NCT01816763|EG001|Reported Event|Tablet Based PEG, Followed by Nurse Pain Screen|"tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)~PEG: Eligible patients will be assigned to complete a patient-reported enhanced pain screening with the PEG on a tablet prior to making contact with a nursing staff vital signs screener."
11140357|NCT01816763|EG002|Reported Event|DVPRS, Followed by Nurse Pain Screen|"Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now~DVPRS: Eligible patients will be randomly assigned to complete a patient-reported 'DVPRS' on a tablet prior to making contact with a nursing staff vital signs screener."
11140358|NCT01816776|BG000|Baseline|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
11140359|NCT01816776|BG001|Baseline|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
11140360|NCT01816776|BG002|Baseline|Total|Total of all reporting groups
11009390|NCT01101477|EG002|Reported Event|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
11009391|NCT01101542|BG000|Baseline|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
11009392|NCT01101542|FG000|Participant Flow|Cervarix Group|Subjects who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
11009393|NCT01101542|OG000|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
11009394|NCT01101542|EG000|Reported Event|Cervarix Group|Subjects enrolled for surveillance Year 6, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
11009395|NCT01101750|BG000|Baseline|Liver and Kidney Transplant Patient Arm|"Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant.~Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6.~Serum samples on day one, month 3 and month 7."
11009396|NCT01101750|FG000|Participant Flow|Liver and Kidney Transplant Arm|"Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant.~Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6.~Serum samples on day one, month 3 and month 7."
11009397|NCT01101750|OG000|Outcome|Liver and Kidney Transplant Patient Arm|"Standard of Care Intervention: Participants on this arm receive Gardisil vaccine and have a history of liver transplant.~Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6.~Serum samples on day one, month 3 and month 7."
11009398|NCT01101750|EG000|Reported Event|Liver and Kidney Transplant Arm|"Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant.~Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6.~Serum samples on day one, month 3 and month 7."
11009399|NCT01101841|BG000|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
11009400|NCT01101841|BG001|Baseline|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
11009401|NCT01101841|BG002|Baseline|Total|Total of all reporting groups
11009402|NCT01101841|FG000|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
11009403|NCT01101841|FG001|Participant Flow|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
11009404|NCT01101841|OG000|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
11009405|NCT01101841|OG001|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
11009406|NCT01101841|OG000|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either MesaBrisdelle (paroxetine mesylate) Capsules fem or placebo capsules in a 1:1 ratio.
11009407|NCT01101841|EG000|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
11009408|NCT01101841|EG001|Reported Event|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
11009409|NCT01101867|BG000|Baseline|Flexible Dose|aspart dose determined based upon carbohydrate intake.
11009410|NCT01101867|BG001|Baseline|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
11009411|NCT01101867|BG002|Baseline|Total|Total of all reporting groups
11009412|NCT01101867|FG000|Participant Flow|Flexible Dose|Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
11140361|NCT01816776|FG000|Participant Flow|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
11140362|NCT01816776|FG001|Participant Flow|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
11140363|NCT01816776|OG000|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
11140364|NCT01816776|OG001|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
11140365|NCT01816776|OG000|Outcome|Pooled Group|All randomized participants pooled. All subjects were implanted with the remedē System device and received optimal medical therapy. The Treatment group had received 12 months active therapy and Control had received 6 months active therapy.
11140366|NCT01816776|EG000|Reported Event|Pooled Group|The study protocol pre-specified that randomized groups be combined to assess safety. All subjects were implanted with the remedē System device and received optimal medical therapy. The Treatment group had received 12 months active therapy and Control had received 6 months active therapy.
11140367|NCT01816893|BG000|Baseline|Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp|"Participant undergoes a euglycemic hyperinsulinemic clamp~Participant undergoes a 1-3 month washout period~Participant undergoes a hypoglycemic hyperinsulinemic clamp"
11140368|NCT01816893|BG001|Baseline|Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp|"Participant undergoes a hypoglycemic hyperinsulinemic clamp~Participant undergoes a 1-3 month washout period~Participant undergoes a euglycemic hyperinsulinemic clamp"
11140369|NCT01816893|BG002|Baseline|Total|Total of all reporting groups
11140370|NCT01816893|FG000|Participant Flow|Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp|"Participant undergoes a euglycemic hyperinsulinemic clamp~Participant undergoes a 1-3 month washout period~Participant undergoes a hypoglycemic hyperinsulinemic clamp"
11140371|NCT01816893|FG001|Participant Flow|Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp|"Participant undergoes a hypoglycemic hyperinsulinemic clamp~Participant undergoes a 1-3 month washout period~Participant undergoes a euglycemic hyperinsulinemic clamp"
11140372|NCT01816893|OG000|Outcome|Euglycemic Clamp|"participant undergoes a euglycemic hyperinsulinemic clamp~Euglycemia"
11140373|NCT01816893|OG001|Outcome|Hypoglycemic Clamp|"participant undergoes a hypoglycemic hyperinsulinemic clamp~Hypoglycemia"
11140374|NCT01816893|EG000|Reported Event|Euglycemic Clamp|Participant undergoes a euglycemic hyperinsulinemic clamp
11140375|NCT01816893|EG001|Reported Event|Hypoglycemic Clamp|Participant undergoes a hypoglycemic hyperinsulinemic clamp
11140376|NCT01816906|BG000|Baseline|MCP Insole|"The intervention is Footwear: MCP. MCP insoles are commonly used within Diabetic sandals in India.~Footwear: MCP: One group of patients will receive footwear with MCP insoles"
11140377|NCT01816906|BG001|Baseline|PU Insole|"The intervention is Footwear: PU. Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.~Footwear :PU: One group of patients will receive Footwear with PU insoles"
11140378|NCT01816906|BG002|Baseline|Total|Total of all reporting groups
11140379|NCT01816906|FG000|Participant Flow|MCP Insole|"The intervention is Footwear: MCP. MCP insoles are commonly used within Diabetic sandals in India.~Footwear: MCP: One group of patients will receive footwear with MCP insoles"
11140380|NCT01816906|FG001|Participant Flow|PU Insole|"The intervention is Footwear: PU. Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.~Footwear :PU: One group of patients will receive Footwear with PU insoles."
11140381|NCT01816906|OG000|Outcome|MCP Insole|"The intervention is Footwear: MCP. MCP insoles are commonly used within Diabetic sandals in India.~Footwear: MCP: One group of patients will receive footwear with MCP insoles"
11140382|NCT01816906|OG001|Outcome|PU Insole|"The intervention is Footwear: PU. Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.~Footwear :PU: One group of patients will receive Footwear with PU insoles."
11140383|NCT01816906|OG001|Outcome|PU Insole|"The intervention is Footwear: PU. Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.~Footwear :PU: One group of patients will receive Footwear with PU insoles"
11140384|NCT01816906|EG000|Reported Event|MCP Insole|"The intervention is Footwear: MCP. MCP insoles are commonly used within Diabetic sandals in India.~Footwear: MCP: One group of patients will receive footwear with MCP insoles"
11140385|NCT01816906|EG001|Reported Event|PU Insole|"The intervention is Footwear: PU. Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.~Footwear :PU: One group of patients will receive Footwear with PU insoles."
11140386|NCT01816945|BG000|Baseline|Access to MOMBA Web-based Application|"Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health.~MOMBA web-based application: Web-based, interactive, social network application."
11140387|NCT01816945|BG001|Baseline|Smartphone Only|Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message.
11140388|NCT01816945|BG002|Baseline|Total|Total of all reporting groups
11140389|NCT01816945|FG000|Participant Flow|Access to MOMBA Web-based Application|"Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health.~MOMBA web-based application: Web-based, interactive, social network application."
11140390|NCT01816945|FG001|Participant Flow|Smartphone Only|Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message.
11140391|NCT01816945|OG000|Outcome|Access to MOMBA Web-based Application|"Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health.~MOMBA web-based application: Web-based, interactive, social network application."
11140392|NCT01816945|OG001|Outcome|Smartphone Only|Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message.
11140393|NCT01816945|EG000|Reported Event|Access to MOMBA Web-based Application|"Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health.~MOMBA web-based application: Web-based, interactive, social network application."
11140394|NCT01816945|EG001|Reported Event|Smartphone Only|Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message.
11140395|NCT01816984|BG000|Baseline|Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)|"Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter.~All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BKM120: Given PO~cetuximab: Given IV"
11140396|NCT01816984|FG000|Participant Flow|Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)|"Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter.~All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BKM120: Given PO~cetuximab: Given IV"
11140397|NCT01816984|OG000|Outcome|Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)|"Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter.~All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BKM120: Given PO~cetuximab: Given IV"
11140398|NCT01816984|EG000|Reported Event|Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)|"Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter.~All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BKM120: Given PO~cetuximab: Given IV"
11140399|NCT01817075|BG000|Baseline|Arm I (CHG Cleansing Wipe)|"Patients receive CHG cleansing with topical skin wipes QD for 90 days.~Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11140400|NCT01817075|BG001|Baseline|Arm II (Control)|"Patients receive control cleansing with topical skin wipes QD for 90 days.~Laboratory Biomarker Analysis: Correlative studies~Mild Soap Skin Cleanser: Given control cleansing~Questionnaire Administration: Ancillary studies"
11140401|NCT01817075|BG002|Baseline|Total|Total of all reporting groups
11140402|NCT01817075|FG000|Participant Flow|Arm I (CHG Cleansing Wipe)|"Patients receive CHG cleansing with topical skin wipes QD for 90 days.~Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11140403|NCT01817075|FG001|Participant Flow|Arm II (Control)|"Patients receive control cleansing with topical skin wipes QD for 90 days.~Laboratory Biomarker Analysis: Correlative studies~Mild Soap Skin Cleanser: Given control cleansing~Questionnaire Administration: Ancillary studies"
11140404|NCT01817075|OG000|Outcome|Arm I (CHG Cleansing Wipe)|"Patients receive CHG cleansing with topical skin wipes QD for 90 days.~Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11140405|NCT01817075|OG001|Outcome|Arm II (Control)|"Patients receive control cleansing with topical skin wipes QD for 90 days.~Laboratory Biomarker Analysis: Correlative studies~Mild Soap Skin Cleanser: Given control cleansing~Questionnaire Administration: Ancillary studies"
11140406|NCT01817075|EG000|Reported Event|Arm I (CHG Cleansing Wipe)|"Patients receive CHG cleansing with topical skin wipes QD for 90 days.~Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11140407|NCT01817075|EG001|Reported Event|Arm II (Control)|"Patients receive control cleansing with topical skin wipes QD for 90 days.~Laboratory Biomarker Analysis: Correlative studies~Mild Soap Skin Cleanser: Given control cleansing~Questionnaire Administration: Ancillary studies"
11140408|NCT01817374|BG000|Baseline|Evaluation of VCEUS to Determine Response to Chemotherapy|"Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows:~prior to initiation of treatment (baseline);~at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);~at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);~at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.~Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens."
11140409|NCT01817374|FG000|Participant Flow|Evaluation of VCEUS to Determine Response to Chemotherapy|"Patients with breast cancer receiving neoadjuvant chemotherapy will undergo 2D grayscale imaging followed by the quantitative VCEUS imaging as follows:~prior to initiation of treatment (baseline);~at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);~at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);~at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.~Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens."
11140410|NCT01817374|OG000|Outcome|Grayscale Ultrasound|Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
11140411|NCT01817374|OG000|Outcome|VCEUS Perfusion Time to Peak|Time from contrast injection to peak intensity
11140412|NCT01817374|OG000|Outcome|Pathology Residual|Pathology residual tumor measured in millimeters
11140413|NCT01817374|EG000|Reported Event|Definity VCEUS|"Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows:~prior to initiation of treatment (baseline);~at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);~at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);~at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.~Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens."
11140414|NCT01817491|BG000|Baseline|Reduced Fat Vegan Diet|"Plant based diet with as few added oils and fats as possible.~Reduced Fat Vegan Diet"
11140415|NCT01817491|BG001|Baseline|American Heart Association Diet|"Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.~American Heart Association Diet"
11140416|NCT01817491|BG002|Baseline|Total|Total of all reporting groups
11140417|NCT01817491|FG000|Participant Flow|Reduced Fat Vegan Diet|"Plant based diet with as few added oils and fats as possible.~Reduced Fat Vegan Diet"
11140418|NCT01817491|FG001|Participant Flow|American Heart Association Diet|"Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.~American Heart Association Diet"
11140419|NCT01817491|OG000|Outcome|Reduced Fat Vegan Diet|"Plant based diet with as few added oils and fats as possible.~Reduced Fat Vegan Diet"
11140420|NCT01817491|OG001|Outcome|American Heart Association Diet|"Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.~American Heart Association Diet"
11140421|NCT01817491|OG000|Outcome|PB/AHA|
11140422|NCT01817491|EG000|Reported Event|Reduced Fat Vegan Diet|"Plant based diet with as few added oils and fats as possible.~Reduced Fat Vegan Diet"
11140423|NCT01817491|EG001|Reported Event|American Heart Association Diet|"Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.~American Heart Association Diet"
11140424|NCT01817530|BG000|Baseline|Cohort 1: Placebo|Placebo for elagolix BID and placebo for E2/NETA QD
11140425|NCT01817530|BG001|Baseline|Cohort 1: Elagolix 300 mg BID|Elagolix 300 mg BID and placebo for E2/NETA QD
11140426|NCT01817530|BG002|Baseline|Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD|Elagolix 300 mg BID plus LD E2/NETA QD
11140427|NCT01817530|BG003|Baseline|Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD|Elagolix 300 mg BID plus SD E2/NETA QD
11140428|NCT01817530|BG004|Baseline|Cohort 2: Placebo|Placebo for elagolix QD and placebo for E2/NETA QD
11140429|NCT01817530|BG005|Baseline|Cohort 2: Elagolix 600 mg QD|Elagolix 600 mg QD and placebo for E2/NETA QD
11140430|NCT01817530|BG006|Baseline|Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD|Elagolix 600 mg QD plus LD E2/NETA QD
11140431|NCT01817530|BG007|Baseline|Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD|Elagolix 600 mg QD plus SD E2/NETA QD
11140432|NCT01817530|BG008|Baseline|Total|Total of all reporting groups
11140433|NCT01817530|FG000|Participant Flow|Cohort 1: Placebo|Placebo for elagolix twice daily (BID) and placebo for E2/NETA once daily (QD)
11140434|NCT01817530|FG001|Participant Flow|Cohort 1: Elagolix 300 mg BID|Elagolix 300 mg BID and placebo for E2/NETA QD
11140435|NCT01817530|FG002|Participant Flow|Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD|Elagolix 300 mg BID plus low-dose (LD) E2/NETA QD
11140436|NCT01817530|FG003|Participant Flow|Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD|Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
11140437|NCT01817530|FG004|Participant Flow|Cohort 2: Placebo|Placebo for elagolix QD and placebo for E2/NETA QD
11140438|NCT01817530|FG005|Participant Flow|Cohort 2: Elagolix 600 mg QD|Elagolix 600 mg QD and placebo for E2/NETA QD
11140439|NCT01817530|FG006|Participant Flow|Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD|Elagolix 600 mg QD plus LD E2/NETA QD
11140440|NCT01817530|FG007|Participant Flow|Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD|Elagolix 600 mg QD plus SD E2/NETA QD
11140441|NCT01817530|OG000|Outcome|Cohort 1: Placebo|Placebo for elagolix BID and placebo for E2/NETA QD
11140442|NCT01817530|OG001|Outcome|Cohort 1: Elagolix 300 mg BID|Elagolix 300 mg BID and placebo for E2/NETA QD
11140443|NCT01817530|OG002|Outcome|Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD|Elagolix 300 mg BID plus LD E2/NETA QD
11140444|NCT01817530|OG003|Outcome|Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD|Elagolix 300 mg BID plus SD E2/NETA QD
11140445|NCT01817530|OG004|Outcome|Cohort 2: Placebo|Placebo for elagolix QD and placebo for E2/NETA QD
11140446|NCT01817530|OG005|Outcome|Cohort 2: Elagolix 600 mg QD|Elagolix 600 mg QD and placebo for E2/NETA QD
11140447|NCT01817530|OG006|Outcome|Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD|Elagolix 600 mg QD plus LD E2/NETA QD
11140448|NCT01817530|OG007|Outcome|Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD|Elagolix 600 mg QD plus SD E2/NETA QD
11140449|NCT01817530|EG000|Reported Event|Cohort 1: Placebo|Placebo for elagolix BID and placebo for E2/NETA QD
11140450|NCT01817530|EG001|Reported Event|Cohort 1: Elagolix 300 mg BID|Elagolix 300 mg BID and placebo for E2/NETA QD
11140451|NCT01817530|EG002|Reported Event|Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD|Elagolix 300 mg BID plus LD E2/NETA QD
11140452|NCT01817530|EG003|Reported Event|Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD|Elagolix 300 mg BID plus SD E2/NETA QD
11140453|NCT01817530|EG004|Reported Event|Cohort 2: Placebo|Placebo for elagolix QD and placebo for E2/NETA QD
11140454|NCT01817530|EG005|Reported Event|Cohort 2: Elagolix 600 mg QD|Elagolix 600 mg QD and placebo for E2/NETA QD
11140455|NCT01817530|EG006|Reported Event|Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD|Elagolix 600 mg QD plus LD E2/NETA QD
11140456|NCT01817530|EG007|Reported Event|Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD|Elagolix 600 mg QD plus SD E2/NETA QD
11140457|NCT01817582|BG000|Baseline|Lotemax Gel 0.5% and Restasis 0.05%|Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140458|NCT01817582|BG001|Baseline|Lotemax Gel 0.5%|Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140459|NCT01817582|BG002|Baseline|Restasis 0.05%|Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140460|NCT01817582|BG003|Baseline|Total|Total of all reporting groups
11140461|NCT01817582|FG000|Participant Flow|Lotemax Gel 0.5% and Restasis 0.05%|Participants administered lotemax gel (loteprednol etabonate ophthalmic gel) 0.5 percent (%) twice daily (BID) in both eyes (OU) for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion (cyclosporin ophthalmic emulsion) 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140462|NCT01817582|FG001|Participant Flow|Lotemax Gel 0.5%|Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140463|NCT01817582|FG002|Participant Flow|Restasis 0.05%|Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140464|NCT01817582|OG000|Outcome|Lotemax Gel 0.5% and Restasis 0.05%|Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140465|NCT01817582|OG001|Outcome|Lotemax Gel 0.5%|Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140466|NCT01817582|OG002|Outcome|Restasis 0.05%|Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140467|NCT01817582|EG000|Reported Event|Lotemax Gel 0.5% and Restasis 0.05%|Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140468|NCT01817582|EG001|Reported Event|Lotemax Gel 0.5%|Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140469|NCT01817582|EG002|Reported Event|Restasis 0.05%|Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
11140470|NCT01817712|BG000|Baseline|Individual Placement and Support (IPS)|"Individual Placement & Support: IPS uses an integrated place-train approach to help people obtain and maintain community-based competitive employment in their chosen occupation."
11140471|NCT01817712|BG001|Baseline|VA Transitional Work Program (TWP)|"VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the train-place or stepwise model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role."
11140472|NCT01817712|BG002|Baseline|Total|Total of all reporting groups
11140473|NCT01817712|FG000|Participant Flow|1 Individual Placement and Support (IPS)|"Individual Placement & Support: IPS uses an integrated place-train approach to help people obtain and maintain community-based competitive employment in their chosen occupation."
11140474|NCT01817712|FG001|Participant Flow|VA Transitional Work Program (TWP)|"VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the train-place or stepwise model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role."
11140475|NCT01817712|OG000|Outcome|Individual Placement and Support (IPS)|"Individual Placement & Support: IPS uses an integrated place-train approach to help people obtain and maintain community-based competitive employment in their chosen occupation."
11140476|NCT01817712|OG001|Outcome|VA Transitional Work Program (TWP)|"VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the train-place or stepwise model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role."
11140477|NCT01817712|EG000|Reported Event|Individual Placement and Support (IPS)|"Individual Placement & Support: IPS uses an integrated place-train approach to help people obtain and maintain community-based competitive employment in their chosen occupation."
11140478|NCT01817712|EG001|Reported Event|VA Transitional Work Program (TWP)|"VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the train-place or stepwise model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role."
11140479|NCT01817725|BG000|Baseline|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old."
11140480|NCT01817725|FG000|Participant Flow|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
11140481|NCT01817725|OG000|Outcome|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
11140482|NCT01817725|EG000|Reported Event|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
11140483|NCT01817764|BG000|Baseline|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
11140484|NCT01817764|BG001|Baseline|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
11140485|NCT01817764|BG002|Baseline|Total|Total of all reporting groups
11140486|NCT01817764|FG000|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
11140487|NCT01817764|FG001|Participant Flow|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
11140488|NCT01817764|OG000|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
11140489|NCT01817764|OG001|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
11140490|NCT01817764|EG000|Reported Event|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
11140491|NCT01817764|EG001|Reported Event|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
11140492|NCT01817777|BG000|Baseline|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
11140493|NCT01817777|BG001|Baseline|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month's supply of metformin.
11140494|NCT01817777|BG002|Baseline|Total|Total of all reporting groups
11140495|NCT01817777|FG000|Participant Flow|Routine Metformin|Participants were followed during an 8-week Observational Phase. During this phase, participants visited the pharmacy and purchased metformin (MTF) as per their usual routines.
11140496|NCT01817777|FG001|Participant Flow|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
11140497|NCT01817777|FG002|Participant Flow|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month's supply of metformin.
11140498|NCT01817777|OG000|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
11140499|NCT01817777|OG001|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month's supply of metformin.
11140500|NCT01817777|EG000|Reported Event|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
11140501|NCT01817777|EG001|Reported Event|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month's supply of metformin.
11140502|NCT01817790|BG000|Baseline|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
11140503|NCT01817790|BG001|Baseline|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
11140504|NCT01817790|BG002|Baseline|Total|Total of all reporting groups
11140505|NCT01817790|FG000|Participant Flow|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
11140506|NCT01817790|FG001|Participant Flow|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
11140507|NCT01817790|OG000|Outcome|Fluticasone Propionate Nasal Spray|Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.
11140508|NCT01817790|OG001|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
11140509|NCT01817790|OG000|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
11140510|NCT01817790|OG001|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
11140511|NCT01817790|EG000|Reported Event|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
11140512|NCT01817790|EG001|Reported Event|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
11140513|NCT01817855|BG000|Baseline|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
11140514|NCT01817855|BG001|Baseline|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
11140515|NCT01817855|BG002|Baseline|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
11140516|NCT01817855|BG003|Baseline|Placebo COPD|COPD Patients with Placebo, once daily
11140517|NCT01817855|BG004|Baseline|Total|Total of all reporting groups
11140518|NCT01817855|FG000|Participant Flow|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
11140519|NCT01817855|FG001|Participant Flow|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
11140520|NCT01817855|FG002|Participant Flow|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
11140521|NCT01817855|FG003|Participant Flow|Placebo COPD|COPD Patients with Placebo, once daily
11140522|NCT01817855|OG000|Outcome|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
11140523|NCT01817855|OG001|Outcome|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
11140524|NCT01817855|OG002|Outcome|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
11140525|NCT01817855|OG003|Outcome|Placebo COPD|COPD Patients with Placebo, once daily
11140526|NCT01817855|OG000|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
11140527|NCT01817855|OG001|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
11140528|NCT01817855|OG002|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
11140529|NCT01817855|OG003|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
11140530|NCT01817855|OG004|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
11140531|NCT01817855|OG005|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
11140532|NCT01817855|EG000|Reported Event|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
11140533|NCT01817855|EG001|Reported Event|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
11140534|NCT01817855|EG002|Reported Event|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
11140535|NCT01817855|EG003|Reported Event|Placebo COPD|COPD Patients with Placebo, once daily
11140536|NCT01817907|BG000|Baseline|Placebo First|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
11140537|NCT01817907|BG001|Baseline|Trazodone First|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
11140538|NCT01817907|BG002|Baseline|Total|Total of all reporting groups
11140539|NCT01817907|FG000|Participant Flow|Placebo First|Subjects will receive a sugar pill (placebo) during their first sleep study night and will receive a pill of trazodone (100 mg) during their second sleep study night.
11140540|NCT01817907|FG001|Participant Flow|Trazodone First|Subjects will receive a pill of trazodone (100 mg) during their first sleep study night and will receive a sugar pill (placebo) during their second sleep study night.
11140541|NCT01817907|OG000|Outcome|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
11140542|NCT01817907|OG001|Outcome|Trazodone|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
11140543|NCT01817907|EG000|Reported Event|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
11140544|NCT01817907|EG001|Reported Event|Trazodone|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
11140545|NCT01817959|BG000|Baseline|Reparixin Group|"Continuous iv infusion~Reparixin: Continuous i.v. infusion into a central vein for 7 days, starting approximately 12 hrs (6-18 hrs) before each pancreatic islet infusion.The Investigational Product (IP) were to be administered as an add-on treatment for the immunosuppressant regimen."
11140546|NCT01817959|BG001|Baseline|Placebo Group|"Continuous iv infusion~Placebo: Continuous infusion at a volume/rate matching active treatment.The placebo was to be administered as well as an add-on treatment for the immunosuppressant regimen."
11140547|NCT01817959|BG002|Baseline|Total|Total of all reporting groups
11140548|NCT01817959|FG000|Participant Flow|Reparixin Group|"Continuous iv infusion~Reparixin: Continuous i.v. infusion into a central vein for 7 days, starting approximately 12 hrs (6-18 hrs) before each pancreatic islet infusion.The Investigational Product (IP) were to be administered as an add-on treatment for the immunosuppressant regimen."
11140549|NCT01817959|FG001|Participant Flow|Placebo Group|"Continuous iv infusion~Placebo: Continuous infusion at a volume/rate matching active treatment.The placebo was to be administered as well as an add-on treatment for the immunosuppressant regimen."
11140550|NCT01817959|OG000|Outcome|Reparixin Group|"Continuous iv infusion~Reparixin: Continuous i.v. infusion into a central vein for 7 days, starting approximately 12 hrs (6-18 hrs) before each pancreatic islet infusion.The Investigational Product (IP) were to be administered as an add-on treatment for the immunosuppressant regimen."
11140551|NCT01817959|OG001|Outcome|Placebo Group|"Continuous iv infusion~Placebo: Continuous infusion at a volume/rate matching active treatment.The placebo was to be administered as well as an add-on treatment for the immunosuppressant regimen."
11140552|NCT01817959|EG000|Reported Event|Reparixin Group|"Continuous iv infusion~Reparixin: Continuous i.v. infusion into a central vein for 7 days, starting approximately 12 hrs (6-18 hrs) before each pancreatic islet infusion.The Investigational Product (IP) were to be administered as an add-on treatment for the immunosuppressant regimen."
11140553|NCT01817959|EG001|Reported Event|Placebo Group|"Continuous iv infusion~Placebo: Continuous infusion at a volume/rate matching active treatment.The placebo was to be administered as well as an add-on treatment for the immunosuppressant regimen."
11140554|NCT01818063|BG000|Baseline|Arm 1 (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV"
11140555|NCT01818063|BG001|Baseline|Arm 2 (Veliparib, Paclitaxel, Carboplatin)|"Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV~Veliparib: Given PO"
11140556|NCT01818063|BG002|Baseline|Total|Total of all reporting groups
11140557|NCT01818063|FG000|Participant Flow|Arm 1 (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV"
11140558|NCT01818063|FG001|Participant Flow|Arm 2 (Veliparib, Paclitaxel, Carboplatin)|"Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV~Veliparib: Given PO"
11140559|NCT01818063|OG000|Outcome|Arm 1 (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV"
11140560|NCT01818063|OG001|Outcome|Arm 2 (Veliparib, Paclitaxel, Carboplatin)|"Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV~Veliparib: Given PO"
11140561|NCT01818063|EG000|Reported Event|Arm 1 (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV"
11140562|NCT01818063|EG001|Reported Event|Arm 2 (Veliparib, Paclitaxel, Carboplatin)|"Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV~Veliparib: Given PO"
11140563|NCT01818141|BG000|Baseline|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
11140564|NCT01818141|BG001|Baseline|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
11140565|NCT01818141|BG002|Baseline|Total|Total of all reporting groups
11140566|NCT01818141|FG000|Participant Flow|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
11140567|NCT01818141|FG001|Participant Flow|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
11140568|NCT01818141|OG000|Outcome|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
11140569|NCT01818141|OG001|Outcome|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
11140570|NCT01818141|EG000|Reported Event|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
11140571|NCT01818141|EG001|Reported Event|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
11140572|NCT01818245|BG000|Baseline|LY2605541: Cohort A (Participants ≤55 Years of Age)|"Participants ≤55 years of age were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 16-28 day washout.~Intervention A: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 of the treatment period.~Intervention B: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 of the treatment period.~Intervention C: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 of the treatment period."
11140573|NCT01818245|BG001|Baseline|LY2605541: Cohort B (Participants ≥65 Years of Age)|Participants ≥65 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.
11140574|NCT01818245|BG002|Baseline|Total|Total of all reporting groups
11140575|NCT01818245|FG000|Participant Flow|LY2605541: Cohort A (Participants ≤55 Years of Age)|"Participants ≤55 years of age were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 16-28 day washout.~Intervention A: participants ≤55 years of age received 1 subcutaneous (SC) injection of 0.5 Units per kilogram (U/kg) of LY2605541 in the abdominal wall on Day 1 of the treatment period.~Intervention B: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 of the treatment period.~Intervention C: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 of the treatment period."
11140576|NCT01818245|FG001|Participant Flow|LY2605541: Cohort B (Participants ≥65 Years of Age)|Participants ≥65 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.
11140577|NCT01818245|OG000|Outcome|LY2605541: Cohort A (Injection Site: Abdomen)|Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
11140578|NCT01818245|OG001|Outcome|LY2605541: Cohort A (Injection Site: Upper Arm)|Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
11140579|NCT01818245|OG002|Outcome|LY2605541: Cohort A (Injection Site: Thigh)|Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
11140580|NCT01818245|OG001|Outcome|LY2605541: Cohort B (Injection Site: Abdomen)|Participants ≥65 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.
11140581|NCT01818245|OG000|Outcome|LY2605541 - Cohort A (Injection Site: Abdomen)|Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
11140582|NCT01818245|EG000|Reported Event|LY2605541: Cohort A (Injection Site: Abdomen)|Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
11140583|NCT01818245|EG001|Reported Event|LY2605541: Cohort A (Injection Site: Upper Arm)|Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
11140584|NCT01818245|EG002|Reported Event|LY2605541: Cohort A (Injection Site: Thigh)|Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
11140585|NCT01818245|EG003|Reported Event|LY2605541: Cohort B (Injection Site: Abdomen)|Participants ≥65 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.
11140586|NCT01818258|BG000|Baseline|Severe Malnutrition Cohort|Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
11140587|NCT01818258|BG001|Baseline|Normal Nutrition/Mild Malnutrition Cohort|Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
11140588|NCT01818258|BG002|Baseline|Total|Total of all reporting groups
11140589|NCT01818258|FG000|Participant Flow|Severe Malnutrition Cohort|Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
11140590|NCT01818258|FG001|Participant Flow|Normal Nutrition/Mild Malnutrition Cohort|Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
11140591|NCT01818258|OG000|Outcome|Severe Malnutrition Cohort|Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
11140592|NCT01818258|OG001|Outcome|Normal Nutrition/Mild Malnutrition Cohort|Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
11140593|NCT01818258|OG001|Outcome|Normal Nutrition/Mild Malnutrition Cohort|"Normal Nutrition or Mild Malnutrition at Entry~ZDV+3TC+LPV/r"
11140594|NCT01818258|EG000|Reported Event|Severe Malnutrition|Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
11140595|NCT01818258|EG001|Reported Event|Normal Nutrition/Mild Malnutrition|Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
11140596|NCT01818284|BG000|Baseline|Donors Filgrastim + Plerixafor|Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x10^6 CD34+ cells/kg (recipient's weight) obtained.
11140597|NCT01818284|BG001|Baseline|Recipients|Recipients received Plerixafor mobilized cells on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan).
11140598|NCT01818284|BG002|Baseline|Total|Total of all reporting groups
11140599|NCT01818284|FG000|Participant Flow|Filgrastim + Plerixafor for Donors|Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x10^6 CD34+ cells/kg (recipient's weight) obtained.
11140600|NCT01818284|FG001|Participant Flow|Recipients|Recipients received Plerixafor mobilized cells for allogeneic hematopoietic stem cell transplantation (HSCT) on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan).
11140601|NCT01818284|OG000|Outcome|Donors: Filgrastim + Plerixafor|Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose obtained.
11140602|NCT01818284|EG000|Reported Event|Donors Filgrastim + Plerixafor|Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x106 CD34+ cells/kg (recipient's weight) obtained.
11140603|NCT01818284|EG001|Reported Event|Recipients|Recipients received Plerixafor mobilized cells on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan).
11140604|NCT01818297|BG000|Baseline|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
11140605|NCT01818297|BG001|Baseline|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
11140606|NCT01818297|BG002|Baseline|Total|Total of all reporting groups
11140607|NCT01818297|FG000|Participant Flow|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
11140608|NCT01818297|FG001|Participant Flow|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
11140609|NCT01818297|OG000|Outcome|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
11140610|NCT01818297|OG001|Outcome|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
11140611|NCT01818297|EG000|Reported Event|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
11140612|NCT01818297|EG001|Reported Event|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
11140613|NCT01818336|BG000|Baseline|Safety Population|All subjects who had skin testing performed (i.e., administered any component of the Penicillin Skin Test Kit).
11140614|NCT01818336|FG000|Participant Flow|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine and control results were valid) and who received the oral amoxicillin challenge.
11140615|NCT01818336|FG001|Participant Flow|Subjects in Retest Population|All subjects who initially tested positive to any of the initial skin tests with penicillin reagents and subsequently returned after 4 weeks for retesting.
11140616|NCT01818336|OG000|Outcome|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine control results are valid) and who receive the oral amoxicillin challenge.
11140617|NCT01818336|EG000|Reported Event|Safety Population-All Study-Emergent Adverse Events|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
11140618|NCT01818336|EG001|Reported Event|Subjects With AE Related to Skin Testing|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s)."
11140619|NCT01818336|EG002|Reported Event|Subjects With AE Related to Oral Amox Challenge|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
11140620|NCT01818414|BG000|Baseline|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
11140621|NCT01818414|BG001|Baseline|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
11140622|NCT01818414|BG002|Baseline|Total|Total of all reporting groups
11140623|NCT01818414|FG000|Participant Flow|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
11140624|NCT01818414|FG001|Participant Flow|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
11140625|NCT01818414|OG000|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
11140626|NCT01818414|OG001|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
11140627|NCT01818414|OG000|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
11140628|NCT01818414|OG001|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
11140629|NCT01818414|EG000|Reported Event|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S
11140630|NCT01818414|EG001|Reported Event|Placebo Comparator: Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
11140631|NCT01818427|BG000|Baseline|Plasma|"infusion of 2 units of plasma~infusion of 2 units of plasma: infusion of 2 units of plasma"
11140632|NCT01818427|BG001|Baseline|Standard Air Medical Care|control group
11140633|NCT01818427|BG002|Baseline|Total|Total of all reporting groups
11140634|NCT01818427|FG000|Participant Flow|Plasma|"infusion of 2 units of plasma~infusion of 2 units of plasma: infusion of 2 units of plasma"
11140635|NCT01818427|FG001|Participant Flow|Standard Air Medical Care|control group
11140636|NCT01818427|OG000|Outcome|Plasma|"infusion of 2 units of plasma~infusion of 2 units of plasma: infusion of 2 units of plasma"
11140637|NCT01818427|OG001|Outcome|Standard Air Medical Care|control group
11140638|NCT01818427|EG000|Reported Event|Plasma|"infusion of 2 units of plasma~infusion of 2 units of plasma: infusion of 2 units of plasma"
11140639|NCT01818427|EG001|Reported Event|Standard Air Medical Care|control group
11140640|NCT01818492|BG000|Baseline|NI-0501|All patients received emapalumab at a starting dose of 1 mg/kg every 3 days with possible escalation up to 10 mg/kg, for a minimum of 4 weeks.
11140641|NCT01818492|FG000|Participant Flow|NI-0501|All patients received emapalumab at a starting dose of 1 mg/kg every 3 days with possible escalation up to 10 mg/kg, for a minimum of 4 weeks.
11140642|NCT01818492|OG000|Outcome|NI-0501|All patients received emapalumab at a starting dose of 1 mg/kg every 3 days with possible escalation up to 10 mg/kg, for a minimum of 4 weeks.
11140643|NCT01818492|EG000|Reported Event|Pre-conditioning|All patients before start of conditioning. Conditioning is the treatments used to prepare a patient for stem cell transplantation.
11140644|NCT01818492|EG001|Reported Event|Post-conditioning|All patients after start of conditioning. Conditioning is the treatments used to prepare a patient for stem cell transplantation.
11140645|NCT01818518|BG000|Baseline|Prelabor Rupture of Membranes Diagnosis on Admission|Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission
11140646|NCT01818518|BG001|Baseline|Preterm Labor Diagnosis on Admission|Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission
11140647|NCT01818518|BG002|Baseline|Pre-eclampsia Diagnosis on Admission|The diagnosis of Preeclampsia at time of admission
11140648|NCT01818518|BG003|Baseline|IUGR Diagnosis on Admission|The diagnosis of IUGR at time of admission
11140649|NCT01818518|BG004|Baseline|Vaginal Bleeding Diagnosis on Admission|The diagnosis of vaginal bleeding made at time of admission
11140650|NCT01818518|BG005|Baseline|Short Cervix Diagnosis on Admission|The diagnosis of Short cervical length at time of admission
11140651|NCT01818518|BG006|Baseline|Total|Total of all reporting groups
11140652|NCT01818518|FG000|Participant Flow|Prelabor Rupture of Membranes Diagnosis on Admission|Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission
11140653|NCT01818518|FG001|Participant Flow|Preterm Labor Diagnosis on Admission|Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission
11140654|NCT01818518|FG002|Participant Flow|Pre-eclampsia Diagnosis on Admission|The diagnosis of Preeclampsia at time of admission
11140655|NCT01818518|FG003|Participant Flow|Intrauterine Growth Restriction (IUGR) Diagnosis on Admission|The diagnosis of IUGR at time of admission
11140656|NCT01818518|FG004|Participant Flow|Vaginal Bleeding Diagnosis on Admission|The diagnosis of vaginal bleeding made at time of admission
11140657|NCT01818518|FG005|Participant Flow|Short Cervix Diagnosis on Admission|The diagnosis of Short cervical length at time of admission
11140658|NCT01818518|OG000|Outcome|Prelabor Rupture of Membranes Diagnosis on Admission|Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission
11140659|NCT01818518|OG001|Outcome|Preterm Labor Diagnosis on Admission|Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission
11140660|NCT01818518|OG002|Outcome|Pre-eclampsia Diagnosis on Admission|The diagnosis of Preeclampsia at time of admission
11140661|NCT01818518|OG003|Outcome|IUGR Diagnosis on Admission|The diagnosis of IUGR at time of admission
11140662|NCT01818518|OG004|Outcome|Vaginal Bleeding Diagnosis on Admission|The diagnosis of vaginal bleeding made at time of admission
11140663|NCT01818518|OG005|Outcome|Short Cervix Diagnosis on Admission|The diagnosis of Short cervical length at time of admission
11140664|NCT01818518|EG000|Reported Event|Preterm Labor|Group who goes into labor prior to 32 weeks of gestation
11140665|NCT01818518|EG001|Reported Event|Prelabor Rupture of Membranes|Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor.
11140666|NCT01818518|EG002|Reported Event|IUGR Diagnosis on Admission|Group who have the diagnosis of intrauterine growth restriction on admission to the hospital.
11140667|NCT01818518|EG003|Reported Event|Pre-Eclampsia Diagnosis on Admission|Group who have the diagnosis of pre-eclampsia noted on admission to the hospital
11140668|NCT01818518|EG004|Reported Event|Vaginal Bleeding Diagnosis on Admission|Group who have the presence of vaginal bleeding noted at the time of admission to the hospital
11140669|NCT01818518|EG005|Reported Event|Short Cervix Diagnosis on Admission|Group who have the diagnosis of a short cervical length at the time of admission to the hospital
11140670|NCT01818531|BG000|Baseline|Adductor Canal Block|"Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.~Adductor canal block"
11140671|NCT01818531|BG001|Baseline|Lumbar Plexus Block|"Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.~Lumbar plexus block"
11140672|NCT01818531|BG002|Baseline|Total|Total of all reporting groups
11140673|NCT01818531|FG000|Participant Flow|Adductor Canal Block|"Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.~Adductor canal block"
11140674|NCT01818531|FG001|Participant Flow|Lumbar Plexus Block|"Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.~Lumbar plexus block"
11140675|NCT01818531|OG000|Outcome|Adductor Canal Block|"Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.~Adductor canal block"
11140676|NCT01818531|OG001|Outcome|Lumbar Plexus Block|"Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.~Lumbar plexus block"
11140677|NCT01818531|EG000|Reported Event|Adductor Canal Block|"Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.~Adductor canal block"
11140678|NCT01818531|EG001|Reported Event|Lumbar Plexus Block|"Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.~Lumbar plexus block"
11140679|NCT01818596|BG000|Baseline|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 240 weeks in ART-experienced participants
11140680|NCT01818596|BG001|Baseline|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 188 weeks in ART-naive participants
11140681|NCT01818596|BG002|Baseline|Total|Total of all reporting groups
11140682|NCT01818596|FG000|Participant Flow|Cohort 1 (Treatment-experienced)|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered orally once daily with food for up to 240 weeks in antiretroviral treatment (ART)-experienced participants
11140683|NCT01818596|FG001|Participant Flow|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 188 weeks in ART-naive participants
11140684|NCT01818596|OG000|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 240 weeks in ART-experienced participants
11140685|NCT01818596|OG001|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 188 weeks in ART-naive participants
11140686|NCT01818596|OG000|Outcome|Substudy Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 240 weeks
11140687|NCT01818596|EG000|Reported Event|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 240 weeks in ART-experienced participants
11140688|NCT01818596|EG001|Reported Event|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 188 weeks in ART-naive participants
11140689|NCT01818700|BG000|Baseline|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
11140690|NCT01818700|FG000|Participant Flow|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision. The up-titration will be considered by investigator's judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
11140691|NCT01818700|OG000|Outcome|Single Arm-Norspan Patch (Buprenorphine)|This study is single study with buprenorphine. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision. The up-titration will be considered by investigator's judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
11140692|NCT01818700|OG000|Outcome|Single Arm-Norspan Patch (Buprenorphine)|"This trial is single arm with Norspan patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision. The up-titration will be considered by investigator's judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
11140693|NCT01818700|OG000|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision. The up-titration will be considered by investigator's judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
11140694|NCT01818700|EG000|Reported Event|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
11140695|NCT01818726|BG000|Baseline|Serum Ferritin Level ≥ 1,000 μg/l|Transfusion-dependent adult patients with AA and serum ferritin ≥ 1000 mg/L on programmed immune suppressive treatment with cyclosporine A who were receiving chelation with Exjade (deferasirox) during the study
11140696|NCT01818726|BG001|Baseline|Serum Ferritin Level < 1,000 μg/l|Transfusion-dependent adult patients with AA and serum ferritin < 1,000 mg/L on programmed immune suppressive treatment with cyclosporine A who were not receiving the investigational product
11140697|NCT01818726|BG002|Baseline|Total|Total of all reporting groups
11140698|NCT01818726|FG000|Participant Flow|Serum Ferritin Level ≥ 1,000 μg/l|Transfusion-dependent adult patients with AA and serum ferritin ≥ 1000 mg/L on programmed immune suppressive treatment with cyclosporine A who were receiving chelation with Exjade (deferasirox) during the study
11140699|NCT01818726|FG001|Participant Flow|Serum Ferritin Level < 1,000 μg/l|Transfusion-dependent adult patients with AA and serum ferritin < 1,000 mg/L on programmed immune suppressive treatment with cyclosporine A who were not receiving the investigational product
11140700|NCT01818726|OG000|Outcome|Serum Ferritin Level ≥ 1,000 μg/l|Transfusion-dependent adult patients with AA and serum ferritin ≥ 1000 mg/L on programmed immune suppressive treatment with cyclosporine A who were receiving chelation with Exjade (deferasirox) during the study
11140701|NCT01818726|OG001|Outcome|Serum Ferritin Level < 1,000 μg/l|Transfusion-dependent adult patients with AA and serum ferritin < 1,000 mg/L on programmed immune suppressive treatment with cyclosporine A who were not receiving the investigational product
11140702|NCT01818726|EG000|Reported Event|Serum Ferritin Level ≥ 1,000 μg/l|Transfusion-dependent adult patients with AA and serum ferritin ≥ 1000 mg/L on programmed immune suppressive treatment with cyclosporine A who were receiving chelation with Exjade (deferasirox) during the study
11140703|NCT01818726|EG001|Reported Event|Serum Ferritin Level < 1,000 μg/l|Transfusion-dependent adult patients with AA and serum ferritin < 1,000 mg/L on programmed immune suppressive treatment with cyclosporine A who were not receiving the investigational product
11140704|NCT01818739|BG000|Baseline|Sentinel Lymph Node Detection|Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
11140705|NCT01818739|FG000|Participant Flow|Sentinel Lymph Node Detection|Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
11140706|NCT01818739|OG000|Outcome|Sentinel Lymph Node Detection|Patients with negative SLN who underwent sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
11140707|NCT01818739|OG000|Outcome|Sentinel Lymph Node Detection|Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
11140708|NCT01818739|EG000|Reported Event|Sentinel Lymph Node Detection|Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
11140709|NCT01818752|BG000|Baseline|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
11140710|NCT01818752|BG001|Baseline|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
11140711|NCT01818752|BG002|Baseline|Total|Total of all reporting groups
11140712|NCT01818752|FG000|Participant Flow|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
11140713|NCT01818752|FG001|Participant Flow|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
11140714|NCT01818752|OG000|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
11140715|NCT01818752|OG001|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
11140716|NCT01818752|EG000|Reported Event|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
11140717|NCT01818752|EG001|Reported Event|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
11140718|NCT01818765|BG000|Baseline|Procedure|20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
11140719|NCT01818765|FG000|Participant Flow|Procedure|20 patients were recruited, 15 with failed transvenous LV (left ventricular) lead placement and 5 non-responders to CRT (cardiac resynchronisation therapy) .
11140720|NCT01818765|OG000|Outcome|Procedure|20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
11140721|NCT01818765|OG000|Outcome|Procedure|"20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.~Baseline BNP (pmol/L) 81 ± 96"
11140722|NCT01818765|EG000|Reported Event|Procedure|20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
11140723|NCT01818804|BG000|Baseline|n-3PUFA|"n-3 polyunsaturated fattyacids from fish oil~n-3PUFA"
11140724|NCT01818804|BG001|Baseline|Olive Oil|"Olive oil~olive oil"
11140725|NCT01818804|BG002|Baseline|Total|Total of all reporting groups
11140726|NCT01818804|FG000|Participant Flow|n-3PUFA|"n-3 polyunsaturated fattyacids from fish oil~3 g of n-3PUFA pr day"
11140727|NCT01818804|FG001|Participant Flow|Olive Oil|"Olive oil~3 g of olive oil pr day"
11140728|NCT01818804|OG000|Outcome|n-3PUFA|"n-3 polyunsaturated fattyacids from fish oil~n-3PUFA"
11140729|NCT01818804|OG001|Outcome|Olive Oil|"Olive oil~olive oil"
11140730|NCT01818804|EG000|Reported Event|n-3PUFA|"n-3 polyunsaturated fattyacids from fish oil~n-3PUFA"
11140731|NCT01818804|EG001|Reported Event|Olive Oil|"Olive oil~olive oil"
11140732|NCT01819129|BG000|Baseline|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
11140733|NCT01819129|BG001|Baseline|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
11140734|NCT01819129|BG002|Baseline|Total|Total of all reporting groups
11140735|NCT01819129|FG000|Participant Flow|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily subcutaneous (sc) injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime self-measured plasma glucose (SMPG) on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
11140736|NCT01819129|FG001|Participant Flow|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
11140737|NCT01819129|OG000|Outcome|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
11140738|NCT01819129|OG001|Outcome|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
11224604|NCT02361736|BG001|Baseline|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers' is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
11224605|NCT02361736|BG002|Baseline|Total|Total of all reporting groups
11140739|NCT01819129|EG000|Reported Event|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
11140740|NCT01819129|EG001|Reported Event|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
11140741|NCT01819194|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed the study lens.
11140742|NCT01819194|FG000|Participant Flow|Overall|Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.
11140743|NCT01819194|OG000|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
11140744|NCT01819194|EG000|Reported Event|Senofilcon A, 38% Water|Senofilcon A, 38% water
11140745|NCT01819233|BG000|Baseline|Behavioral Dietary Intervention|"Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.~Behavioral dietary intervention: Receive caloric restricted dietary intervention~Therapeutic conventional surgery: Undergo definitive lumpectomy~Radiation therapy: Undergo radiation therapy~Counseling intervention: Receive dietary counseling~Quality-of-life assessment: Ancillary studies"
11140746|NCT01819233|FG000|Participant Flow|Behavioral Dietary Intervention|"Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.~Behavioral dietary intervention: Receive caloric restricted dietary intervention~Therapeutic conventional surgery: Undergo definitive lumpectomy~Radiation therapy: Undergo radiation therapy~Counseling intervention: Receive dietary counseling~Quality-of-life assessment: Ancillary studies"
11140747|NCT01819233|OG000|Outcome|Behavioral Dietary Intervention|"Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.~Behavioral dietary intervention: Receive caloric restricted dietary intervention~Therapeutic conventional surgery: Undergo definitive lumpectomy~Radiation therapy: Undergo radiation therapy~Counseling intervention: Receive dietary counseling~Quality-of-life assessment: Ancillary studies"
11140748|NCT01819233|EG000|Reported Event|Behavioral Dietary Intervention|"Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.~Behavioral dietary intervention: Receive caloric restricted dietary intervention~Therapeutic conventional surgery: Undergo definitive lumpectomy~Radiation therapy: Undergo radiation therapy~Counseling intervention: Receive dietary counseling~Quality-of-life assessment: Ancillary studies"
11140749|NCT01819272|BG000|Baseline|Placebo|Placebo once daily in the morning
11140750|NCT01819272|BG001|Baseline|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140751|NCT01819272|BG002|Baseline|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140752|NCT01819272|BG003|Baseline|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140753|NCT01819272|BG004|Baseline|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
11140754|NCT01819272|BG005|Baseline|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
11140755|NCT01819272|BG006|Baseline|Total|Total of all reporting groups
11140756|NCT01819272|FG000|Participant Flow|Placebo|Placebo once daily in the morning
11140757|NCT01819272|FG001|Participant Flow|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140758|NCT01819272|FG002|Participant Flow|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140759|NCT01819272|FG003|Participant Flow|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140760|NCT01819272|FG004|Participant Flow|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
11140761|NCT01819272|FG005|Participant Flow|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
11140762|NCT01819272|OG000|Outcome|Placebo|Placebo once daily in the morning
11140763|NCT01819272|OG001|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140764|NCT01819272|OG002|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140765|NCT01819272|OG003|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140766|NCT01819272|OG004|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
11140767|NCT01819272|OG005|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
11140768|NCT01819272|EG000|Reported Event|Placebo|Placebo once daily in the morning
11140769|NCT01819272|EG001|Reported Event|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140770|NCT01819272|EG002|Reported Event|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140771|NCT01819272|EG003|Reported Event|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
11140772|NCT01819272|EG004|Reported Event|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
11140773|NCT01819272|EG005|Reported Event|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
11140774|NCT01819311|BG000|Baseline|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
11140775|NCT01819311|BG001|Baseline|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
11140776|NCT01819311|BG002|Baseline|Total|Total of all reporting groups
11140777|NCT01819311|FG000|Participant Flow|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
11140778|NCT01819311|FG001|Participant Flow|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
11140779|NCT01819311|OG000|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
11140780|NCT01819311|OG001|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
11140781|NCT01819311|EG000|Reported Event|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
11140782|NCT01819311|EG001|Reported Event|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
11140783|NCT01819415|BG000|Baseline|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
11140784|NCT01819415|BG001|Baseline|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
11140785|NCT01819415|BG002|Baseline|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
11140786|NCT01819415|BG003|Baseline|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
11140787|NCT01819415|BG004|Baseline|Total|Total of all reporting groups
11140788|NCT01819415|FG000|Participant Flow|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
11140789|NCT01819415|FG001|Participant Flow|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
11140790|NCT01819415|FG002|Participant Flow|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
11140791|NCT01819415|FG003|Participant Flow|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
11140792|NCT01819415|OG000|Outcome|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
11140793|NCT01819415|OG001|Outcome|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
11140794|NCT01819415|OG002|Outcome|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
11140795|NCT01819415|OG003|Outcome|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
11140796|NCT01819415|EG000|Reported Event|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
11140797|NCT01819415|EG001|Reported Event|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
11140798|NCT01819415|EG002|Reported Event|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
11140799|NCT01819415|EG003|Reported Event|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
11140800|NCT01819506|BG000|Baseline|MATCH Targeted Task Practice|"Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing just right match between task-difficulty and patient-ability.~Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy."
11140801|NCT01819506|BG001|Baseline|Usual Care: Non-Targeted Task Practice|"Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy.~Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy."
11140802|NCT01819506|BG002|Baseline|Total|Total of all reporting groups
11140803|NCT01819506|FG000|Participant Flow|MATCH|"MATCH is defined as a task-practice occupational therapy program targeting patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing just right match between task-difficulty and patient-ability.~Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy."
11140804|NCT01819506|FG001|Participant Flow|Usual Care|"Usual Care is defined as a non-targeted task practice standard of care occupational therapy program consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy.~Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy."
11140805|NCT01819506|OG000|Outcome|MATCH Targeted Task Practice|"Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing just right match between task-difficulty and patient-ability.~Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy."
11140806|NCT01819506|OG001|Outcome|Usual Care: Non-Targeted Task Practice|"Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy.~Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy."
11140807|NCT01819506|EG000|Reported Event|MATCH Targeted Task Practice|"Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing just right match between task-difficulty and patient-ability.~Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy."
11140808|NCT01819506|EG001|Reported Event|Usual Care: Non-Targeted Task Practice|"Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy.~Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy."
11140809|NCT01819597|BG000|Baseline|EDAS Surgery|"EDAS surgery is an established form of indirect revascularization. The study arm in this study will receive EDAS surgery~Encephaloduroarteriosynangiosis (EDAS): The operation is a form of indirect revascularization or EC-IC bypass, performed under general endotracheal anesthesia, with intraoperative electroencephalographic monitoring. The surgery consists in the dissection and relocation of the superficial temporal artery (STA) and middle meningeal artery (MMA) branches, which are separated from their surrounding tissues under microscopic visualization and re-routed through a craniotomy to be placed intracranially in close proximity to the branches of the middle cerebral artery (MCA). The MCA branches are dissected in the arachnoid space and the STA and MMA are kept in position with microsutures to the arachnoid or MMA dural cuffs, maintaining close contact between the EC and MCA branches."
11224606|NCT02361736|FG000|Participant Flow|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
11224607|NCT02361736|FG001|Participant Flow|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers' is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
11224608|NCT02361736|OG000|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
11224609|NCT02361736|OG001|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers' is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
11224610|NCT02361736|EG000|Reported Event|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
11224611|NCT02361736|EG001|Reported Event|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers' is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
11224612|NCT02361762|BG000|Baseline|Training|"Computerized executive control training~Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.~Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.~A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks."
11224613|NCT02361762|BG001|Baseline|Waitlist|The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
11224614|NCT02361762|BG002|Baseline|Total|Total of all reporting groups
11224615|NCT02361762|FG000|Participant Flow|Training|"Computerized executive control training~Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.~Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.~A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks."
11224616|NCT02361762|FG001|Participant Flow|Waitlist|The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
11224617|NCT02361762|OG000|Outcome|Training|"Computerized executive control training~Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.~Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.~A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks."
11224618|NCT02361762|OG001|Outcome|Waitlist|The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
11224619|NCT02361762|EG000|Reported Event|Training|"Computerized executive control training~Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.~Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.~A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks."
10887434|NCT00500357|FG000|Participant Flow|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 [Vax 1]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
11224620|NCT02361762|EG001|Reported Event|Waitlist|The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
11224621|NCT02362048|BG000|Baseline|Monotherapy Arm|"ACP-196 alone~ACP-196"
11224622|NCT02362048|BG001|Baseline|Combination Arm|"ACP-196 in combination with pembrolizumab~ACP-196 in combination with pembrolizumab"
11224623|NCT02362048|BG002|Baseline|Total|Total of all reporting groups
11224624|NCT02362048|FG000|Participant Flow|Arm 1 - Acalabrutinib Monotherapy|Acalabrutinib 100 mg administered orally (PO) twice daily (BID)
11224625|NCT02362048|FG001|Participant Flow|Arm 2- Acalabrutinib+Pembrolizumab|Acalabrutinib 100 mg PO BID plus pembrolizumab 200 mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)
11224626|NCT02362048|OG000|Outcome|Arm 1 - Acalabrutinib Monotherapy|Acalabrutinib 100 mg administered orally (PO) twice daily (BID)
11224627|NCT02362048|OG001|Outcome|Arm 2- Acalabrutinib+Pembrolizumab|Acalabrutinib 100 mg PO BID plus pembrolizumab 200 mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)
11140810|NCT01819597|FG000|Participant Flow|EDAS Surgery|"EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery~Encephaloduroarteriosynangiosis (EDAS): The operation is a form of indirect revascularization or EC-IC bypass, performed under general endotracheal anesthesia, with intraoperative electroencephalographic monitoring. The surgery consists in the dissection and relocation of the superficial temporal artery (STA) and middle meningeal artery (MMA) branches, which are separated from their surrounding tissues under microscopic visualization and re-routed through a craniotomy to be placed intracranially in close proximity to the branches of the middle cerebral artery (MCA). The MCA branches are dissected in the arachnoid space and the STA and MMA are kept in position with microsutures to the arachnoid or MMA dural cuffs, maintaining close contact between the EC and MCA branches."
11140811|NCT01819597|OG000|Outcome|EDAS Surgery|"EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery~Encephaloduroarteriosynangiosis (EDAS): The operation is a form of indirect revascularization or EC-IC bypass, performed under general endotracheal anesthesia, with intraoperative electroencephalographic monitoring. The surgery consists in the dissection and relocation of the superficial temporal artery (STA) and middle meningeal artery (MMA) branches, which are separated from their surrounding tissues under microscopic visualization and re-routed through a craniotomy to be placed intracranially in close proximity to the branches of the middle cerebral artery (MCA). The MCA branches are dissected in the arachnoid space and the STA and MMA are kept in position with microsutures to the arachnoid or MMA dural cuffs, maintaining close contact between the EC and MCA branches."
11140812|NCT01819597|EG000|Reported Event|EDAS Surgery|"EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery~Encephaloduroarteriosynangiosis (EDAS): The operation is a form of indirect revascularization or EC-IC bypass, performed under general endotracheal anesthesia, with intraoperative electroencephalographic monitoring. The surgery consists in the dissection and relocation of the superficial temporal artery (STA) and middle meningeal artery (MMA) branches, which are separated from their surrounding tissues under microscopic visualization and re-routed through a craniotomy to be placed intracranially in close proximity to the branches of the middle cerebral artery (MCA). The MCA branches are dissected in the arachnoid space and the STA and MMA are kept in position with microsutures to the arachnoid or MMA dural cuffs, maintaining close contact between the EC and MCA branches."
11140813|NCT01819727|BG000|Baseline|BMN 165, 20mg/Day|Subjects who meet the eligibility criteria will be randomized 1:1 to titrate to one of two dose regimens: 20 or 40 mg/day. Randomization will be stratified by the last available blood Phe concentration prior to Day 1 (600-900 μmol/L and > 900 μmol/L). All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the IP, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly dose to a daily dose regimen of 20 or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until 26 weeks-36 weeks in the study.
11140814|NCT01819727|BG001|Baseline|BMN 165, 40mg/Day|Subjects who meet the eligibility criteria will be randomized 1:1 to titrate to one of two dose regimens: 20 or 40 mg/day. Randomization will be stratified by the last available blood Phe concentration prior to Day 1 (600-900 μmol/L and > 900 μmol/L). All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the IP, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly dose to a daily dose regimen of 20 or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until 26 weeks-36 weeks in the study.
11140815|NCT01819727|BG002|Baseline|Total|Total of all reporting groups
11140816|NCT01819727|FG000|Participant Flow|BMN 165, 20mg/Day|Subjects who meet the eligibility criteria will be randomized 1:1 to titrate to one of two dose regimens: 20 or 40 mg/day. Randomization will be stratified by the last available blood Phe concentration prior to Day 1 (600-900 μmol/L and > 900 μmol/L). All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the IP, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly dose to a daily dose regimen of 20 or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until 26 weeks-36 weeks in the study.
11140817|NCT01819727|FG001|Participant Flow|BMN 165, 40mg/Day|Subjects who meet the eligibility criteria will be randomized 1:1 to titrate to one of two dose regimens: 20 or 40 mg/day. Randomization will be stratified by the last available blood Phe concentration prior to Day 1 (600-900 μmol/L and > 900 μmol/L). All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the IP, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly dose to a daily dose regimen of 20 or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until 26 weeks-36 weeks in the study.
11224628|NCT02362048|EG000|Reported Event|Arm 1 - Acalabrutinib Monotherapy|Acalabrutinib 100 mg administered orally (PO) twice daily (BID)
11224629|NCT02362048|EG001|Reported Event|Arm 2- Acalabrutinib+Pembrolizumab|Acalabrutinib 100 mg PO BID plus pembrolizumab 200 mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)
11140818|NCT01819727|OG000|Outcome|BMN 165, 20mg/Day|Subjects who meet the eligibility criteria will be randomized 1:1 to titrate to one of two dose regimens: 20 or 40 mg/day. Randomization will be stratified by the last available blood Phe concentration prior to Day 1 (600-900 μmol/L and > 900 μmol/L). All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the IP, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly dose to a daily dose regimen of 20 or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until 26 weeks-36 weeks in the study.
11140819|NCT01819727|OG001|Outcome|BMN 165, 40mg/Day|Subjects who meet the eligibility criteria will be randomized 1:1 to titrate to one of two dose regimens: 20 or 40 mg/day. Randomization will be stratified by the last available blood Phe concentration prior to Day 1 (600-900 μmol/L and > 900 μmol/L). All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the IP, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly dose to a daily dose regimen of 20 or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until 26 weeks-36 weeks in the study.
11140820|NCT01819727|EG000|Reported Event|BMN 165, 20mg/Day|Subjects who meet the eligibility criteria will be randomized 1:1 to titrate to one of two dose regimens: 20 or 40 mg/day. Randomization will be stratified by the last available blood Phe concentration prior to Day 1 (600-900 μmol/L and > 900 μmol/L). All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the IP, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly dose to a daily dose regimen of 20 or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until 26 weeks-36 weeks in the study.
11140821|NCT01819727|EG001|Reported Event|BMN 165, 40mg/Day|Subjects who meet the eligibility criteria will be randomized 1:1 to titrate to one of two dose regimens: 20 or 40 mg/day. Randomization will be stratified by the last available blood Phe concentration prior to Day 1 (600-900 μmol/L and > 900 μmol/L). All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the IP, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly dose to a daily dose regimen of 20 or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until 26 weeks-36 weeks in the study.
11140822|NCT01819844|BG000|Baseline|Closed-loop Blood Glucose Control|
11140823|NCT01819844|FG000|Participant Flow|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
11140824|NCT01819844|OG000|Outcome|Closed-loop Blood Glucose Control|
11140825|NCT01819844|OG000|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
11140826|NCT01819844|EG000|Reported Event|Closed-loop Blood Glucose Control|
11140827|NCT01819883|BG000|Baseline|Active Acromegaly|All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point.
11140828|NCT01819883|BG001|Baseline|Healthy Controls|
11140829|NCT01819883|BG002|Baseline|Total|Total of all reporting groups
11140830|NCT01819883|FG000|Participant Flow|Active Acromegaly|All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point.
11140831|NCT01819883|FG001|Participant Flow|Healthy Controls|Healthy, matched controls completed a baseline visit only
11140832|NCT01819883|OG000|Outcome|Active Acromegaly|All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: approximately 3 months after treatment of acromegaly. Controls will be studied at one time point.
11140833|NCT01819883|EG000|Reported Event|Active Acromegaly|All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point.
11140834|NCT01819883|EG001|Reported Event|Healthy Controls|Healthy, matched controls
10887435|NCT00500357|OG000|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
11140835|NCT01819922|BG000|Baseline|Overall Participants|All randomized participants who received single dose of PF-05175157 600 mg capsule or single dose of placebo matched to PF-05175157 600 mg capsule in either first or second intervention period.
11140836|NCT01819922|FG000|Participant Flow|PF-05175157 Then Placebo|Participants who met the pre-defined cardiopulmonary exercise test (CPET) criteria, received single dose of PF-05175157 600 milligram (mg) capsule orally in first intervention period then single dose of placebo matched to PF-05175157 capsule, 600 mg orally in second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
11140837|NCT01819922|FG001|Participant Flow|Placebo Then PF-05175157|Participants who met the pre-defined CPET criteria, received single dose of placebo matched to PF-05175157, 600 mg capsule orally in first intervention period then single dose of PF-05175157 600 mg capsule orally in second intervention period. A washout period at least of 7-10 days was maintained between each intervention period.
11140838|NCT01819922|OG000|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
11140839|NCT01819922|OG001|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
11140840|NCT01819922|EG000|Reported Event|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
11140841|NCT01819922|EG001|Reported Event|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
11140842|NCT01819935|BG000|Baseline|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
11140843|NCT01819935|BG001|Baseline|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
11140844|NCT01819935|BG002|Baseline|Total|Total of all reporting groups
11140845|NCT01819935|FG000|Participant Flow|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
11140846|NCT01819935|FG001|Participant Flow|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
11140847|NCT01819935|OG000|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
11140848|NCT01819935|OG001|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
11140849|NCT01819935|EG000|Reported Event|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
11140850|NCT01819935|EG001|Reported Event|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
11140851|NCT01820260|BG000|Baseline|Part 1A: Ingenol Mebutate Gel 0.005%|Administration on full face, once daily for 3 days
11140852|NCT01820260|BG001|Baseline|Part 1A: Ingenol Mebutate Gel 0.008%|Administration on full face, once daily for 3 days
11140853|NCT01820260|BG002|Baseline|Part 1A: Ingenol Mebutate Gel 0.012%|Administration on full face, once daily for 3 days
11140854|NCT01820260|BG003|Baseline|Part 1A: Ingenol Mebutate Gel 0.018%|Administration on full face, once daily for 3 days
11140855|NCT01820260|BG004|Baseline|Part 1A: Ingenol Mebutate Gel 0.027%|Administration on full face, once daily for 3 days
11140856|NCT01820260|BG005|Baseline|Part 1A: Ingenol Mebutate Gel 0.04%|Administration on full face, once daily for 3 days
11140857|NCT01820260|BG006|Baseline|Part 1B: Ingenol Mebutate Gel 0.04%|Administration on full face, once daily for 2 days
11140858|NCT01820260|BG007|Baseline|Part 1B: Ingenol Mebutate Gel 0.06%|Administration on full face, once daily for 2 days
11140859|NCT01820260|BG008|Baseline|Part 2: Ingenol Mebutate Gel 0.018% for 3 Days Treatment|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Ingenol mebutate gel 0.018%"
11140860|NCT01820260|BG009|Baseline|Part 2: Ingenol Mebutate Gel 0.027% for 3 Days Treatment|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Ingenol mebutate gel 0.027%"
11140861|NCT01820260|BG010|Baseline|Part 2: Ingenol Mebutate Gel 0.018% for 2 Days Treatment|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Ingenol mebutate gel 0.018%"
11140862|NCT01820260|BG011|Baseline|Part 2: Ingenol Mebutate Gel 0.027% for 2 Days Treatment|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Ingenol mebutate gel 0.027%"
11140863|NCT01820260|BG012|Baseline|Part 2: Vehicle Gel (Placebo)for 2 Days Treatment|"Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Vehicle gel (placebo)"
11140864|NCT01820260|BG013|Baseline|Part 2: Vehicle Gel (Placebo) for 3 Days Treatment|"Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Vehicle gel (placebo)"
11140865|NCT01820260|BG014|Baseline|Total|Total of all reporting groups
11140866|NCT01820260|FG000|Participant Flow|Part 1A: Ingenol Mebutate Gel 0.005%|Administration on full face, once daily for 3 consecutive days
11140867|NCT01820260|FG001|Participant Flow|Part 1A: Ingenol Mebutate Gel 0.008%|Administration on full face, once daily for 3 consecutive days
11140868|NCT01820260|FG002|Participant Flow|Part 1A: Ingenol Mebutate Gel 0.012%|Administration on full face, once daily for 3 consecutive days
11140869|NCT01820260|FG003|Participant Flow|Part 1A: Ingenol Mebutate Gel 0.018%|Administration on full face, once daily for 3 consecutive days
11140870|NCT01820260|FG004|Participant Flow|Part 1A: Ingenol Mebutate Gel 0.027%|Administration on full face, once daily for 3 consecutive days
11140871|NCT01820260|FG005|Participant Flow|Part 1A: Ingenol Mebutate Gel 0.04%|Administration on full face, once daily for 3 consecutive days
11140872|NCT01820260|FG006|Participant Flow|Part 1B: Ingenol Mebutate Gel 0.06%|Administration on full face, once daily for 2 consecutive days
11140873|NCT01820260|FG007|Participant Flow|Part 1B: Ingenol Mebutate Gel 0.04%|Administration on full face, once daily for 2 consecutive days
11140874|NCT01820260|FG008|Participant Flow|Part 2: Ingenol Mebutate Gel 0.018% for 2 Days|Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days
11140875|NCT01820260|FG009|Participant Flow|Part 2: Ingenol Mebutate Gel 0.018% for 3 Days|Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days
11140876|NCT01820260|FG010|Participant Flow|Part 2: Ingenol Mebutate Gel 0.027% for 2 Days|Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days
11140877|NCT01820260|FG011|Participant Flow|Part 2: Ingenol Mebutate Gel 0.027% for 3 Days|Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days
11140878|NCT01820260|FG012|Participant Flow|Part 2: Vehicle Gel (Placebo) for 2 Days|Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days
11140879|NCT01820260|FG013|Participant Flow|Part 2: Vehicle Gel (Placebo) for 3 Days|Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days
11140880|NCT01820260|OG000|Outcome|Part 1A: Ingenol Mebutate Gel 0.005%|Administration on full face, once daily for 3 consecutive days
11140881|NCT01820260|OG001|Outcome|Part 1A: Ingenol Mebutate Gel 0.008%|Administration on full face, once daily for 3 consecutive days
11140882|NCT01820260|OG002|Outcome|Part 1A: Ingenol Mebutate Gel 0.012%|Administration on full face, once daily for 3 consecutive days
11140883|NCT01820260|OG003|Outcome|Part 1A: Ingenol Mebutate Gel 0.018%|Administration on full face, once daily for 3 consecutive days
11140884|NCT01820260|OG004|Outcome|Part 1A: Ingenol Mebutate Gel 0.027%|Administration on full face, once daily for 3 consecutive days
11140885|NCT01820260|OG005|Outcome|Part 1A: Ingenol Mebutate Gel 0.04%|Administration on full face, once daily for 3 consecutive days
11140886|NCT01820260|OG006|Outcome|Part 1B: Ingenol Mebutate Gel 0.04%|Administration on full face, once daily for 2 consecutive days
11140887|NCT01820260|OG007|Outcome|Part 1B: Ingenol Mebutate Gel 0.06%|Administration on full face, once daily for 2 consecutive days
11140888|NCT01820260|OG000|Outcome|Ingenol Mebutate Gel 0.018% for 3 Days|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Ingenol mebutate gel 0.018%"
11140889|NCT01820260|OG001|Outcome|Ingenol Mebutate Gel 0.018% for 2 Days|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Ingenol mebutate gel 0.018%"
11140890|NCT01820260|OG002|Outcome|Ingenol Mebutate Gel 0.027% for 3 Days|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Ingenol mebutate gel 0.027%"
11140891|NCT01820260|OG003|Outcome|Ingenol Mebutate Gel 0.027% for 2 Days|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Ingenol mebutate gel 0.027%"
11140892|NCT01820260|OG004|Outcome|Vehicle Gel (Placebo) for 3 Days|"Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Vehicle gel (placebo)"
11140893|NCT01820260|OG005|Outcome|Vehicle Gel (Placebo) for 2 Days|"Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Vehicle gel (placebo"
11140894|NCT01820260|OG000|Outcome|Ingenol Mebutate Gel 0.018% for 3 Days Treatment|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Ingenol mebutate gel 0.018%"
11140895|NCT01820260|OG001|Outcome|Ingenol Mebutate Gel 0.018% for 2 Days Treatment|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Ingenol mebutate gel 0.018%"
11140896|NCT01820260|OG002|Outcome|Ingenol Mebutate Gel 0.027% for 3 Days Treatment|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Ingenol mebutate gel 0.027%"
11140897|NCT01820260|OG003|Outcome|Ingenol Mebutate Gel 0.027% for 2 Days Treatment|"Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Ingenol mebutate gel 0.027%"
11140898|NCT01820260|OG004|Outcome|Vehicle Gel (Placebo) for 3 Days Treatment|"Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days~Vehicle gel (placebo)"
11140899|NCT01820260|OG005|Outcome|Vehicle Gel (Placebo)for 2 Days Treatment|"Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days~Vehicle gel (placebo)"
11140900|NCT01820260|EG000|Reported Event|Part 1A: Ingenol Mebutate Gel 0.005%|Administration on full face, once daily 3 days
11140901|NCT01820260|EG001|Reported Event|Part 1A: Ingenol Mebutate Gel 0.008%|Administration on full face, once daily 3 days
11140902|NCT01820260|EG002|Reported Event|Part 1A: Ingenol Mebutate Gel 0.012%|Administration on full face, once daily 3 days
11140903|NCT01820260|EG003|Reported Event|Part 1A: Ingenol Mebutate Gel 0.018%|Administration on full face, once daily 3 days
11140904|NCT01820260|EG004|Reported Event|Part 1A: Ingenol Mebutate Gel 0.027%|Administration on full face, once daily 3 days
11140905|NCT01820260|EG005|Reported Event|Part 1A: Ingenol Mebutate Gel 0.04%|Administration on full face, once daily 3 days
11140906|NCT01820260|EG006|Reported Event|Part 1B: Ingenol Mebutate Gel 0.04%|Administration on full face, once daily 2 days
11140907|NCT01820260|EG007|Reported Event|Part 1B: Ingenol Mebutate Gel 0.06%|Administration on full face, once daily 3 days
11140908|NCT01820260|EG008|Reported Event|Part 2: Ingenol Mebutate Gel 0.018% for 3 Days|Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days
11140909|NCT01820260|EG009|Reported Event|Part 2: Ingenol Mebutate Gel 0.018% for 2 Days|Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days
11140910|NCT01820260|EG010|Reported Event|Part 2: Ingenol Mebutate Gel 0.027% for 3 Days|Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days
11140911|NCT01820260|EG011|Reported Event|Part 2: Ingenol Mebutate Gel 0.027% for 2 Days|Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days
11140912|NCT01820260|EG012|Reported Event|Part 2: Vehicle Gel (Placebo) for 3 Days|Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days
11140913|NCT01820260|EG013|Reported Event|Part 2: Vehicle Gel (Placebo) for 2 Days|Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days
11140914|NCT01820364|BG000|Baseline|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
11140915|NCT01820364|FG000|Participant Flow|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
11140916|NCT01820364|FG001|Participant Flow|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
11140917|NCT01820364|OG000|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
11140918|NCT01820364|OG001|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
11140919|NCT01820364|OG000|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
11140920|NCT01820364|EG000|Reported Event|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
11140921|NCT01820416|BG000|Baseline|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
11140922|NCT01820416|BG001|Baseline|Disabled Laser|Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
11140923|NCT01820416|BG002|Baseline|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
11140924|NCT01820416|BG003|Baseline|Total|Total of all reporting groups
11140925|NCT01820416|FG000|Participant Flow|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
11140926|NCT01820416|FG001|Participant Flow|Disabled Laser|"Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Placebo Comparator: Disabled Laser: Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation."
11140927|NCT01820416|FG002|Participant Flow|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
11224630|NCT02362191|BG000|Baseline|Single Session tACS Across Menstrual Cycle|"Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle.~Alternating Current Stimulator: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11140928|NCT01820416|OG000|Outcome|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
11140929|NCT01820416|OG001|Outcome|Disabled Laser|"Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Placebo Comparator: Disabled Laser: Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation."
11140930|NCT01820416|OG002|Outcome|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
11140931|NCT01820416|EG000|Reported Event|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
11140932|NCT01820416|EG001|Reported Event|Disabled Laser|Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
11140933|NCT01820416|EG002|Reported Event|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
11140934|NCT01820559|BG000|Baseline|Placebo|"Placebo tablets~Placebo : Tablets"
11140935|NCT01820559|BG001|Baseline|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
11140936|NCT01820559|BG002|Baseline|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
11140937|NCT01820559|BG003|Baseline|Total|Total of all reporting groups
11140938|NCT01820559|FG000|Participant Flow|Placebo|"Placebo tablets~Placebo : Tablets"
11140939|NCT01820559|FG001|Participant Flow|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
11140940|NCT01820559|FG002|Participant Flow|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
11140941|NCT01820559|OG000|Outcome|Placebo|"Placebo tablets~Placebo : Tablets"
11140942|NCT01820559|OG001|Outcome|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
11140943|NCT01820559|OG002|Outcome|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
11140944|NCT01820559|EG000|Reported Event|Placebo|"Placebo tablets~Placebo : Tablets"
11140945|NCT01820559|EG001|Reported Event|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
11140946|NCT01820559|EG002|Reported Event|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
11149760|NCT01873287|FG000|Participant Flow|Derivation Arm|"Inclusion criteria. Subjects presenting to one of the study hospital EDs after sustaining a head injury will be eligible if they: (1) are aged 5 to 17 years; (2) have a concussion, defined by Zurich consensus statement; (3) suffered the initial injury in the previous 48 hours; (4) are proficient in English or French.~Exclusion criteria. Patients will be excluded if they present with traumatic head injuries with any of the following: GCS ≤13; any abnormality on standard neuroimaging studies,; neurosurgical operative intervention, intubation or PICU care required; multi-system injuries with treatment requiring admission to hospital, operating room or procedural sedation in the ED; severe chronic neurological developmental delay resulting in communication difficulties; intoxication at the time of ED presentation as per clinician judgment; no clear history of trauma as primary event (e.g., seizure, syncope or migraine as primary event); previously enrolled in this same study."
11149761|NCT01873287|FG001|Participant Flow|Validation Arm|"Inclusion criteria. Subjects presenting to one of the study hospital EDs after sustaining a head injury will be eligible if they: (1) are aged 5 to 17 years; (2) have a concussion, defined by Zurich consensus statement; (3) suffered the initial injury in the previous 48 hours; (4) are proficient in English or French.~Exclusion criteria. Patients will be excluded if they present with traumatic head injuries with any of the following: GCS ≤13; any abnormality on standard neuroimaging studies,; neurosurgical operative intervention, intubation or PICU care required; multi-system injuries with treatment requiring admission to hospital, operating room or procedural sedation in the ED; severe chronic neurological developmental delay resulting in communication difficulties; intoxication at the time of ED presentation as per clinician judgment; no clear history of trauma as primary event (e.g., seizure, syncope or migraine as primary event); previously enrolled in this same study."
11149762|NCT01873287|OG000|Outcome|PPCS in Derivation|August 2013 to September 2014
11149763|NCT01873287|OG001|Outcome|PPCS in Validation|October 2014 to June 2015
11149764|NCT01873287|OG000|Outcome|Participants With PPCS|The primary outcome measure, PPCS, was defined in keeping with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) definition of postconcussion syndrome, which requires persistence beyond 4 weeks of at least 3 symptoms compared with state of being prior to the injury. In the study, an individual symptom was defined as a positive difference between the patient-reported current minus the perceived preinjury symptom rating on PCSI; both were completed 28 days after the injury.
11149765|NCT01873287|OG001|Outcome|Participants Without PPCS|Less than 3 symptoms compared with state of being prior to the injury at 28 days. In the study, an individual symptom was defined as a positive difference between the patient-reported current minus the perceived preinjury symptom rating on PCSI; both were completed 28 days after the injury.
11149766|NCT01873287|OG000|Outcome|Number of Children With Neuropsychological Impairment|Incidence of neuropsychological impairment was determined using the Neuropsychological Impairment (NPI) rule (Beauchamp et al., 2015) and multiple hierarchical logistic and linear regressions were performed to assess the contribution of pre-morbid factors, acute symptoms, and acute cognitive testing to neuropsychological impairment and performance.
11149767|NCT01873287|EG000|Reported Event|Participants|All enrolled participants.
11140947|NCT01820572|BG000|Baseline|Belatacept|Participants who converted to belatacept treatment from CNI-Based
11140948|NCT01820572|BG001|Baseline|CNI-Based Regimen|Participants who continued on CNI-Based regimens
11140949|NCT01820572|BG002|Baseline|Total|Total of all reporting groups
11140950|NCT01820572|FG000|Participant Flow|Belatacept|Participants who converted to belatacept treatment from CNI-Based
11140951|NCT01820572|FG001|Participant Flow|CNI-Based Regimen|Participants who continued on CNI-Based regimens
11140952|NCT01820572|OG000|Outcome|Belatacept|Participants who converted to belatacept treatment from CNI-Based
11140953|NCT01820572|OG001|Outcome|CNI-Based Regimen|Participants who continued on CNI-Based regimens
11140954|NCT01820572|EG000|Reported Event|Belatacept|Participants who converted to belatacept treatment from CNI-Based
11140955|NCT01820572|EG001|Reported Event|CNI-Based Regimen|Participants who continued on CNI-Based regimens
11140956|NCT01820585|BG000|Baseline|Placebo|"Tablets~Placebo : Tablets"
11140957|NCT01820585|BG001|Baseline|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140958|NCT01820585|BG002|Baseline|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140959|NCT01820585|BG003|Baseline|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140960|NCT01820585|BG004|Baseline|Total|Total of all reporting groups
11140961|NCT01820585|FG000|Participant Flow|Placebo|Placebo tablets matching the 400-mg and 600-mg tablets were administered Once daily (QD) by oral route.
11140962|NCT01820585|FG001|Participant Flow|ESL 400 mg|Eslicarbazepine acetate (ESL) 400 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route.
11140963|NCT01820585|FG002|Participant Flow|ESL 800 mg|ESL 800 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route
11140964|NCT01820585|FG003|Participant Flow|ESL 1200 mg|ESL was supplied in 400-mg and 600-mg tablets and was administered QD by oral route.
11140965|NCT01820585|OG000|Outcome|Placebo|"Tablets~Placebo : Tablets"
11140966|NCT01820585|OG001|Outcome|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140967|NCT01820585|OG002|Outcome|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140968|NCT01820585|OG003|Outcome|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140969|NCT01820585|EG000|Reported Event|Placebo|"Tablets~Placebo : Tablets"
11140970|NCT01820585|EG001|Reported Event|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140971|NCT01820585|EG002|Reported Event|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140972|NCT01820585|EG003|Reported Event|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
11140973|NCT01820637|BG000|Baseline|Test Device Arm (DES SFA, ELUVIA™)|"All patients in this arm were treated with the study device.~The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)"
11140974|NCT01820637|FG000|Participant Flow|Test Device Arm (DES SFA, ELUVIA™)|"All patients in this arm were treated with the study device.~The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)"
11140975|NCT01820637|OG000|Outcome|Test Device Arm (DES SFA, ELUVIA™)|All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
11140976|NCT01820637|EG000|Reported Event|Test Device Arm (DES SFA, ELUVIA™)|All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
11140977|NCT01820754|BG000|Baseline|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
11140978|NCT01820754|FG000|Participant Flow|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin Area Under Curve (AUC) 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
11140979|NCT01820754|OG000|Outcome|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
11140980|NCT01820754|EG000|Reported Event|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
11140981|NCT01821105|BG000|Baseline|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
11140982|NCT01821105|FG000|Participant Flow|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
11140983|NCT01821105|OG000|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
11140984|NCT01821105|EG000|Reported Event|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
11140985|NCT01821118|BG000|Baseline|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
11140986|NCT01821118|BG001|Baseline|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
11140987|NCT01821118|BG002|Baseline|Total|Total of all reporting groups
11140988|NCT01821118|FG000|Participant Flow|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
11140989|NCT01821118|FG001|Participant Flow|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
11140990|NCT01821118|OG000|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
11140991|NCT01821118|OG001|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
11140992|NCT01821118|EG000|Reported Event|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
11140993|NCT01821118|EG001|Reported Event|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
11140994|NCT01821300|BG000|Baseline|Down Syndrome|Our goal is to enroll 155 subjects with Down syndrome, and to compare their data to our control group.
11140995|NCT01821300|BG001|Baseline|Control|Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
11140996|NCT01821300|BG002|Baseline|Total|Total of all reporting groups
11140997|NCT01821300|FG000|Participant Flow|Down Syndrome|"154 participants ages 10-20 years old.~No intervention occurred as this is a cross-sectional observational study."
11140998|NCT01821300|FG001|Participant Flow|Control|"103 age-, sex-, race-, ethnicity-, and BMI percentile-matched control subjects.~No intervention occurred as this is a cross-sectional observational study."
11140999|NCT01821300|OG000|Outcome|Down Syndrome|Down syndrome participants in observational study.
11141000|NCT01821300|OG001|Outcome|Control|Control participants in observational study.
11141001|NCT01821300|OG000|Outcome|Down Syndrome (Overweight & Obese Only)|Down syndrome participants in observational study.
11141002|NCT01821300|OG001|Outcome|Control (Overweight Obese Only)|Control participants in observational study.
11141003|NCT01821300|OG000|Outcome|Down Syndrome, Obese|For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
11141004|NCT01821300|OG001|Outcome|Down Syndrome, Not Obese|"Our goal is to enroll 155 subjects with Down syndrome, and to compare their data to our control group.~For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis."
11141005|NCT01821300|OG002|Outcome|Control, Obese|For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
11141006|NCT01821300|OG003|Outcome|Control, Not Obese|"Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.~For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis."
11141007|NCT01821300|EG000|Reported Event|Down Syndrome|Our goal is to enroll 155 subjects with Down syndrome, and to compare their data to our control group.
11141008|NCT01821300|EG001|Reported Event|Control|Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
11141009|NCT01821326|BG000|Baseline|Patients With Obscure Gastrointestinal Bleeding|
11141010|NCT01821326|FG000|Participant Flow|Patients With Obscure Gastrointestinal Bleeding|
11141011|NCT01821326|OG000|Outcome|Patients With Obscure Gastrointestinal Bleeding|
11141012|NCT01821326|EG000|Reported Event|Patients With Obscure Gastrointestinal Bleeding|
11141013|NCT01821352|BG000|Baseline|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
11141014|NCT01821352|BG001|Baseline|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
11141015|NCT01821352|BG002|Baseline|Total|Total of all reporting groups
11141016|NCT01821352|FG000|Participant Flow|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW) 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
11141017|NCT01821352|FG001|Participant Flow|Placebo Laser|Placebo Laser device emits sham green light that has no therapeutic effect.
11141018|NCT01821352|OG000|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
11141019|NCT01821352|OG001|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
11141020|NCT01821352|EG000|Reported Event|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
11141021|NCT01821352|EG001|Reported Event|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
11141022|NCT01821378|BG000|Baseline|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily"
11141023|NCT01821378|BG001|Baseline|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
11141024|NCT01821378|BG002|Baseline|Placebo|Placebo: Once Daily
11141025|NCT01821378|BG003|Baseline|Total|Total of all reporting groups
11141026|NCT01821378|FG000|Participant Flow|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
11141027|NCT01821378|FG001|Participant Flow|Lurasidone 80 mg - 160 mg|"Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
11141028|NCT01821378|FG002|Participant Flow|Placebo|"Placebo Comparator 20 or 80 mg once daily~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
11141029|NCT01821378|OG000|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily"
11141030|NCT01821378|OG001|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
11141031|NCT01821378|OG002|Outcome|Placebo|Placebo: Once Daily
11141032|NCT01821378|OG000|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
11141033|NCT01821378|OG000|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
11141034|NCT01821378|OG000|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
11141035|NCT01821378|OG001|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
11141036|NCT01821378|OG002|Outcome|Placebo|Randomized to Placebo group at baseline
11141037|NCT01821378|EG000|Reported Event|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
11141038|NCT01821378|EG001|Reported Event|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 (one subject who was randomized was not treated with study drug, therefore, excluded from the safety population).
11141039|NCT01821378|EG002|Reported Event|Placebo|Placebo: Once Daily
11141040|NCT01821391|BG000|Baseline|Group 1|Participants applied single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix cream topically followed by c- PDT (active comparator) on Day 0 (Baseline).
11141041|NCT01821391|BG001|Baseline|Group 2|Participants applied a single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix vehicle cream (placebo) followed by c-PDT on Day 0 (Baseline).
11141042|NCT01821391|BG002|Baseline|Total|Total of all reporting groups
11141043|NCT01821391|FG000|Participant Flow|Group 1|Participants applied single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix cream topically followed by c- PDT (active comparator) on Day 0 (Baseline).
11141044|NCT01821391|FG001|Participant Flow|Group 2|Participants applied a single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix vehicle cream (placebo) followed by c-PDT on Day 0 (Baseline).
11141045|NCT01821391|OG000|Outcome|Group I: Metvix NDL-PDT|Participants applied topically a single dose of Metvix cream followed by NDL-PDT on Day 0 (Baseline).
11141046|NCT01821391|OG001|Outcome|Group I: Metvix c-PDT|Participants applied topically a single dose of Metvix cream followed by C-PDT on Day 0 (Baseline).
11141047|NCT01821391|EG000|Reported Event|NDL-PDT|Metvix natural daylight photodynamic therapy treated side
11141048|NCT01821391|EG001|Reported Event|c-PDT|Metvix conventional photodynamic therapy treated side
11141049|NCT01821391|EG002|Reported Event|Placebo c-PDT|Placebo conventional photodynamic therapy treated side
11141050|NCT01821391|EG003|Reported Event|Unspecific Treated Side|AE occuring outside the treated area + systemic AE
11141051|NCT01821417|BG000|Baseline|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
11141052|NCT01821417|BG001|Baseline|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
11141053|NCT01821417|BG002|Baseline|Total|Total of all reporting groups
11141054|NCT01821417|FG000|Participant Flow|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
11141055|NCT01821417|FG001|Participant Flow|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
11141056|NCT01821417|OG000|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
11141057|NCT01821417|OG001|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
11141058|NCT01821417|EG000|Reported Event|Microtextured Dental Implant|"Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures.~Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures."
11141059|NCT01821417|EG001|Reported Event|Dental Implant|"Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures.~Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures."
11141060|NCT01821534|BG000|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was administered.
11141061|NCT01821534|FG000|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was administered.
11141062|NCT01821534|OG000|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
11141063|NCT01821534|EG000|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was administered.
11141064|NCT01821560|BG000|Baseline|Sugar Pill|"Placebo-treated subjects will follow the identical schedule as Baclofen subjects.~placebo"
11141065|NCT01821560|BG001|Baseline|Baclofen|"Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.~Baclofen"
11141066|NCT01821560|BG002|Baseline|Total|Total of all reporting groups
11141067|NCT01821560|FG000|Participant Flow|Sugar Pill|"Placebo-treated subjects will follow the identical schedule as Baclofen subjects.~placebo"
11141068|NCT01821560|FG001|Participant Flow|Baclofen|"Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.~Baclofen"
11141069|NCT01821560|OG000|Outcome|Sugar Pill|"Placebo-treated subjects will follow the identical schedule as Baclofen subjects.~placebo"
11141070|NCT01821560|OG001|Outcome|Baclofen|"Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.~Baclofen"
11141071|NCT01821560|EG000|Reported Event|Sugar Pill|"Placebo-treated subjects will follow the identical schedule as Baclofen subjects.~placebo"
11141072|NCT01821560|EG001|Reported Event|Baclofen|"Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.~Baclofen"
11141073|NCT01821625|BG000|Baseline|Thrombocytopenic (Low Platelet) Patients|"All study patients will undergo intervention in this study.~The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).~Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study."
11141074|NCT01821625|FG000|Participant Flow|Thrombocytopenic (Low Platelet) Patients|"All study patients will undergo intervention in this study.~The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).~Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study."
11141075|NCT01821625|OG000|Outcome|Thrombocytopenic (Low Platelet) Patients|"All study patients will undergo intervention in this study.~The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).~Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study."
11141076|NCT01821625|EG000|Reported Event|Thrombocytopenic (Low Platelet) Patients|"All study patients will undergo intervention in this study.~The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).~Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.~One subject completed the study as planned. Four subjects had to drop out of the study early for different reasons. One subject was not able to start the hepatitis C triple therapy medications due to a medical condition, two subjects discontinued due to lack of virologic response and one subject discontinued treatment due to side effects."
11141077|NCT01821729|BG000|Baseline|Experimental Arm|"FOLFIRINOX, Losartan, Proton Beam Radiation Therapy~FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes~Losartan: Taken orally every day during Phase I for all 8 cycles~Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday"
11141078|NCT01821729|FG000|Participant Flow|Experimental Arm|"FOLFIRINOX, Losartan, Proton Beam Radiation Therapy~FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes~Losartan: Taken orally every day during Phase I for all 8 cycles~Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday"
11141079|NCT01821729|OG000|Outcome|Experimental Arm|"FOLFIRINOX, Losartan, Proton Beam Radiation Therapy~FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes~Losartan: Taken orally every day during Phase I for all 8 cycles~Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday"
11141080|NCT01821729|EG000|Reported Event|Experimental Arm|"FOLFIRINOX, Losartan, Proton Beam Radiation Therapy~FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes~Losartan: Taken orally every day during Phase I for all 8 cycles~Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday"
11141081|NCT01821807|BG000|Baseline|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
11141082|NCT01821807|BG001|Baseline|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
11141083|NCT01821807|BG002|Baseline|Total|Total of all reporting groups
11141084|NCT01821807|FG000|Participant Flow|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
11141085|NCT01821807|FG001|Participant Flow|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
11141086|NCT01821807|OG000|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
11141087|NCT01821807|OG001|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
11141088|NCT01821807|EG000|Reported Event|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
11141089|NCT01821807|EG001|Reported Event|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
11141090|NCT01821937|BG000|Baseline|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
11141091|NCT01821937|BG001|Baseline|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
11141092|NCT01821937|BG002|Baseline|Total|Total of all reporting groups
11141093|NCT01821937|FG000|Participant Flow|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
11141094|NCT01821937|FG001|Participant Flow|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
11149768|NCT01873417|BG000|Baseline|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
11141095|NCT01821937|OG000|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
11141096|NCT01821937|OG001|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
11141097|NCT01821937|EG000|Reported Event|Faldaprevir 120 mg Single Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
11141098|NCT01821937|EG001|Reported Event|Faldaprevir 120 mg Multiple Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
11141099|NCT01821937|EG002|Reported Event|Faldaprevir 240 mg Single Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
11141100|NCT01821937|EG003|Reported Event|Faldaprevir 240 mg Multiple Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
11141101|NCT01822119|BG000|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
11141102|NCT01822119|FG000|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
11141103|NCT01822119|OG000|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
11141104|NCT01822119|EG000|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
11141105|NCT01822132|BG000|Baseline|Extended Release Naltrexone|"One dose of intramuscular injection of 380mg extended-release naltrexone.~Extended release naltrexone"
11141106|NCT01822132|BG001|Baseline|Placebo|"One dose of intramuscular injection of placebo.~Placebo"
11141107|NCT01822132|BG002|Baseline|Total|Total of all reporting groups
11141108|NCT01822132|FG000|Participant Flow|Naltrexone|One dose of intramuscular injection of 380mg extended-release naltrexone.
11141109|NCT01822132|FG001|Participant Flow|Placebo|One dose of intramuscular injection of placebo.
11141110|NCT01822132|OG000|Outcome|Naltrexone|Participants who were randomized to naltrexone.
11141111|NCT01822132|OG001|Outcome|Placebo|Participants who were randomized to receive placebo.
11141112|NCT01822132|OG000|Outcome|Naltrexone|One dose of intramuscular injection of 380mg extended-release naltrexone.
11141113|NCT01822132|OG001|Outcome|Placebo|One dose of intramuscular injection of placebo.
11141114|NCT01822132|OG000|Outcome|Naltrexone|Participants randomized to naltrexone.
11141115|NCT01822132|OG001|Outcome|Placebo|Participants randomized to placebo.
11141116|NCT01822132|OG000|Outcome|Extended Release Naltrexone|"One dose of intramuscular injection of 380mg extended-release naltrexone.~Extended release naltrexone"
11141117|NCT01822132|OG001|Outcome|Placebo|"One dose of intramuscular injection of placebo.~Placebo"
11141118|NCT01822132|EG000|Reported Event|Extended Release Naltrexone|"One dose of intramuscular injection of 380mg extended-release naltrexone.~Extended release naltrexone"
11141119|NCT01822132|EG001|Reported Event|Placebo|"One dose of intramuscular injection of placebo.~Placebo"
11141120|NCT01822197|BG000|Baseline|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
11141121|NCT01822197|FG000|Participant Flow|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
11141122|NCT01822197|OG000|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
11141123|NCT01822197|EG000|Reported Event|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
11141124|NCT01822223|BG000|Baseline|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
11141125|NCT01822223|BG001|Baseline|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
11141126|NCT01822223|BG002|Baseline|Total|Total of all reporting groups
11141127|NCT01822223|FG000|Participant Flow|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
11141128|NCT01822223|FG001|Participant Flow|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
11141129|NCT01822223|OG000|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
11141130|NCT01822223|OG001|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
11141131|NCT01822223|OG000|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
11141132|NCT01822223|OG001|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
11141133|NCT01822223|EG000|Reported Event|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
11141134|NCT01822223|EG001|Reported Event|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
11141135|NCT01822301|BG000|Baseline|Repeat Facial Fat Grafting|Repeat Fat grafting: Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. We treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. .
11141136|NCT01822301|FG000|Participant Flow|Repeat Facial Fat Grafting|Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
11141137|NCT01822301|OG000|Outcome|Facial Volume Score at Baseline|facial volume score at baseline, pre-op
11141138|NCT01822301|OG001|Outcome|Facial Volume Score at 7-21 Day PO|facial volume score at 7-21 days post-operation
11141139|NCT01822301|OG002|Outcome|Facial Volume Score at 3 Month PO|facial volume score at 3 months post-operation
11141140|NCT01822301|OG003|Outcome|Facial Volume Score at 9 Months PO|facial volume score at 3 months post-operation
11141141|NCT01822301|OG000|Outcome|CT Imaging at 7-21 Days PO|CT imaging at 7-21 days post-operation
11141142|NCT01822301|OG001|Outcome|CT Imaging at 3 Months PO|CT imaging at 3 months post-operation
11141143|NCT01822301|OG002|Outcome|CT Imaging at 9 Months PO|CT imaging at 9 months post-operation
11141144|NCT01822301|EG000|Reported Event|Repeat Facial Fat Grafting|Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
11141145|NCT01822353|BG000|Baseline|Milk Allergy|"Dietary supplement, milk in increasing dosages, delivered daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141146|NCT01822353|BG001|Baseline|Nut Allergy|"Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141147|NCT01822353|BG002|Baseline|Egg Allergy|"Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141148|NCT01822353|BG003|Baseline|Total|Total of all reporting groups
11141149|NCT01822353|FG000|Participant Flow|Milk Allergy|"Dietary supplement, milk in increasing dosages, delivered daily and orally.~Dietary supplement: Milk oral immunotherapy"
11141150|NCT01822353|FG001|Participant Flow|Nut Allergy|"Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.~Dietary supplement: Nut oral immunotherapy"
11141151|NCT01822353|FG002|Participant Flow|Egg Allergy|"Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.~Dietary supplement: Egg oral immunotherapy"
11141152|NCT01822353|OG000|Outcome|Milk Allergy|"Dietary supplement, milk in increasing dosages, delivered daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141153|NCT01822353|OG001|Outcome|Nut Allergy|"Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141154|NCT01822353|OG002|Outcome|Egg Allergy|"Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141155|NCT01822353|OG000|Outcome|Milk Allergy|"Dietary supplement, milk in increasing dosages, delivered daily and orally.~Dietary supplement: Milk oral immunotherapy"
11141156|NCT01822353|OG001|Outcome|Nut Allergy|"Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.~Dietary supplement: Nut oral immunotherapy"
11141157|NCT01822353|OG002|Outcome|Egg Allergy|"Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.~Dietary supplement: Egg oral immunotherapy"
11141158|NCT01822353|EG000|Reported Event|Milk Allergy|"Dietary supplement, milk in increasing dosages, delivered daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141159|NCT01822353|EG001|Reported Event|Nut Allergy|"Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141160|NCT01822353|EG002|Reported Event|Egg Allergy|"Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.~Dietary supplement: Milk, egg or nut oral immunotherapy"
11141161|NCT01822366|BG000|Baseline|Usual Care Comparison Condition - Children|Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
11141162|NCT01822366|BG001|Baseline|Trauma-focused CBT Group Therapy - Children|"Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141163|NCT01822366|BG002|Baseline|Usual Care Comparison Condition - Caregivers|Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
11141164|NCT01822366|BG003|Baseline|Trauma-focused CBT Group Therapy - Caregivers|"Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141165|NCT01822366|BG004|Baseline|Total|Total of all reporting groups
11141166|NCT01822366|FG000|Participant Flow|Usual Care Comparison Condition - Children|Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
11141167|NCT01822366|FG001|Participant Flow|Trauma-focused CBT Group Therapy - Children|"Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141168|NCT01822366|FG002|Participant Flow|Usual Care Comparison Condition - Caregivers|Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
11141169|NCT01822366|FG003|Participant Flow|Trauma-focused CBT Group Therapy - Caregivers|"Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141170|NCT01822366|OG000|Outcome|Tanzania Rural Comparison Child|Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
11141171|NCT01822366|OG001|Outcome|Tanzania Urban Comparison Child|Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
11141172|NCT01822366|OG002|Outcome|Tanzania Rural TF-CBT Child|"Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141173|NCT01822366|OG003|Outcome|Tanzania Urban TF-CBT Child|"Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141174|NCT01822366|OG004|Outcome|Kenya Rural Comparison Child|Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
11141175|NCT01822366|OG005|Outcome|Kenya Urban Comparison Child|Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
11141176|NCT01822366|OG006|Outcome|Kenya Rural TF-CBT Child|"Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141177|NCT01822366|OG007|Outcome|Kenya Urban TF-CBT Child|"Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141178|NCT01822366|OG008|Outcome|Tanzania Rural Comparison Caregiver|Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
11141179|NCT01822366|OG009|Outcome|Tanzania Urban Comparison Caregiver|Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
11141180|NCT01822366|OG010|Outcome|Tanzania Rural TF-CBT Caregiver|"Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141181|NCT01822366|OG011|Outcome|Tanzania Urban TF-CBT Caregiver|"Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141182|NCT01822366|OG012|Outcome|Kenya Rural Comparison Caregiver|Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
11141183|NCT01822366|OG013|Outcome|Kenya Urban Comparison Caregiver|Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
11141184|NCT01822366|OG014|Outcome|Kenya Rural TF-CBT Caregiver|"Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141185|NCT01822366|OG015|Outcome|Kenya Urban TF-CBT Caregiver|"Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141186|NCT01822366|OG000|Outcome|Tanzania Rural Comparison Child|Half of the participating children will receive no intervention (usual care) to serve as a control.
11141187|NCT01822366|OG001|Outcome|Tanzania Urban Comparison Child|Half of the participating children will receive no intervention (usual care) to serve as a control.
11141188|NCT01822366|OG002|Outcome|Tanzania Rural TF-CBT Child|"Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141189|NCT01822366|OG003|Outcome|Tanzania Urban TF-CBT Child|"Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141190|NCT01822366|OG004|Outcome|Kenya Rural Comparison Child|Half of the participating children will receive no intervention (usual care) to serve as a control.
11141191|NCT01822366|OG005|Outcome|Kenya Urban Comparison Child|Half of the participating children will receive no intervention (usual care) to serve as a control.
11141192|NCT01822366|OG006|Outcome|Kenya Rural TF-CBT Child|"Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141193|NCT01822366|OG007|Outcome|Kenya Urban TF-CBT Child|"Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141194|NCT01822366|EG000|Reported Event|Usual Care Comparison Condition|Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
11141195|NCT01822366|EG001|Reported Event|Trauma-focused CBT Group Therapy|"Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.~Trauma-focused Cognitive Behavioral Therapy"
11141196|NCT01822457|BG000|Baseline|Nike FuelBand (NFB)|"Patients will receive a Nike Fuel Band to encourage exercise.~Nike FuelBand (NFB): The Nike Fuel Band (NFB) is a wrist-worn sensor with a built-in accelerometer for motion quantification. It is programmed to estimate the number of steps taken per day, and also predict energy expenditure in units known as Nike Fuel. Accompanying software allows the user to set daily targets and monitor their activity through a graphical user interface."
11141197|NCT01822457|BG001|Baseline|Control|Standard follow-up
11141198|NCT01822457|BG002|Baseline|Total|Total of all reporting groups
11141199|NCT01822457|FG000|Participant Flow|Nike FuelBand (NFB)|"Patients will receive a Nike Fuel Band to encourage exercise.~Nike FuelBand (NFB): The Nike Fuel Band (NFB) is a wrist-worn sensor with a built-in accelerometer for motion quantification. It is programmed to estimate the number of steps taken per day, and also predict energy expenditure in units known as Nike Fuel. Accompanying software allows the user to set daily targets and monitor their activity through a graphical user interface."
11141200|NCT01822457|FG001|Participant Flow|Control|Standard follow-up
11141201|NCT01822457|OG000|Outcome|Nike FuelBand (NFB)|"Patients will receive a Nike Fuel Band to encourage exercise.~Nike FuelBand (NFB): The Nike Fuel Band (NFB) is a wrist-worn sensor with a built-in accelerometer for motion quantification. It is programmed to estimate the number of steps taken per day, and also predict energy expenditure in units known as Nike Fuel. Accompanying software allows the user to set daily targets and monitor their activity through a graphical user interface."
11141202|NCT01822457|OG001|Outcome|Control|Standard follow-up
11141203|NCT01822457|EG000|Reported Event|Nike FuelBand (NFB)|"Patients will receive a Nike Fuel Band to encourage exercise.~Nike FuelBand (NFB): The Nike Fuel Band (NFB) is a wrist-worn sensor with a built-in accelerometer for motion quantification. It is programmed to estimate the number of steps taken per day, and also predict energy expenditure in units known as Nike Fuel. Accompanying software allows the user to set daily targets and monitor their activity through a graphical user interface."
11141204|NCT01822457|EG001|Reported Event|Control|Standard follow-up
11141205|NCT01822496|BG000|Baseline|EGFR: Erlotinib|Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
11141206|NCT01822496|BG001|Baseline|EGFR: No Erlotinib|Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
11141207|NCT01822496|BG002|Baseline|ALK: Crizotinib|Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
11141208|NCT01822496|BG003|Baseline|ALK: No Crizotinib|Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
11141209|NCT01822496|BG004|Baseline|Total|Total of all reporting groups
11141210|NCT01822496|FG000|Participant Flow|EGFR: Erlotinib|Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
11141211|NCT01822496|FG001|Participant Flow|EGFR: No Erlotinib|Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
11141212|NCT01822496|FG002|Participant Flow|ALK: Crizotinib|Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
11141213|NCT01822496|FG003|Participant Flow|ALK: No Crizotinib|Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
11141214|NCT01822496|OG000|Outcome|EGFR: Erlotinib|Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
11141215|NCT01822496|OG001|Outcome|EGFR: No Erlotinib|Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
11141216|NCT01822496|OG002|Outcome|ALK: Crizotinib|Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
11141217|NCT01822496|OG003|Outcome|ALK: No Crizotinib|Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
11141218|NCT01822496|EG000|Reported Event|EGFR: Erlotinib|Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
11141219|NCT01822496|EG001|Reported Event|EGFR: No Erlotinib|Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
11141220|NCT01822496|EG002|Reported Event|ALK: Crizotinib|Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
11141221|NCT01822496|EG003|Reported Event|ALK: No Crizotinib|Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
11141222|NCT01822535|BG000|Baseline|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
11141223|NCT01822535|BG001|Baseline|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
11141224|NCT01822535|BG002|Baseline|Total|Total of all reporting groups
11141225|NCT01822535|FG000|Participant Flow|Tetraplegia|Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years
11141226|NCT01822535|FG001|Participant Flow|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
11141227|NCT01822535|OG000|Outcome|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
11141228|NCT01822535|OG001|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
11141229|NCT01822535|OG000|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
11141230|NCT01822535|OG001|Outcome|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
11141231|NCT01822535|EG000|Reported Event|No Drug: Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
11141232|NCT01822535|EG001|Reported Event|No Drug: Able-bodied|Age- and gender-matched to individuals with tetraplegia.
11141233|NCT01822535|EG002|Reported Event|Drug: Tetraplegia|Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug)
11141234|NCT01822548|BG000|Baseline|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
11141235|NCT01822548|BG001|Baseline|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
11141236|NCT01822548|BG002|Baseline|Total|Total of all reporting groups
11141237|NCT01822548|FG000|Participant Flow|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
11141238|NCT01822548|FG001|Participant Flow|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
11141239|NCT01822548|OG000|Outcome|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
11141240|NCT01822548|OG001|Outcome|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
11141241|NCT01822548|EG000|Reported Event|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
11141242|NCT01822548|EG001|Reported Event|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
11141243|NCT01822561|BG000|Baseline|CSCR Patients Who Received Eplerenone|All patients were diagnosed with central serous chorioretinopathy. All patients received 50mg oral eplerenone daily for 4 weeks.
11141244|NCT01822561|FG000|Participant Flow|Eplerenone Group|"All patients in this study received Eplerenone 50mg once daily for 4 weeks.~Eplerenone 50mg: All patients received the same dose of eplerenone."
11141245|NCT01822561|OG000|Outcome|Patients That Took Eplerenone|Patients received 50mg oral eplerenone daily for 1 month
11141246|NCT01822561|OG000|Outcome|Patients That Received Eplerenone|Patients took 50mg oral eplerenone daily for 1 month
11141247|NCT01822561|OG000|Outcome|Patients That Took Eplerenone|Patients received oral Eplerenone 50mg once daily for 4 weeks.
11141248|NCT01822561|OG000|Outcome|Patients That Received Eplerenone|Patients received oral Eplerenone 50mg once daily for 4 weeks.
11141249|NCT01822561|OG000|Outcome|Patients That Received Eplerenone|Patients took oral Eplerenone 50mg once daily for 4 weeks.
11141250|NCT01822561|EG000|Reported Event|Eplerenone Group|All patients had central serous chorioretinopathy and were treated with 50mg oral eplerenone once daily
11141251|NCT01822574|BG000|Baseline|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
11141252|NCT01822574|BG001|Baseline|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
11141253|NCT01822574|BG002|Baseline|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
11141254|NCT01822574|BG003|Baseline|Total|Total of all reporting groups
11141255|NCT01822574|FG000|Participant Flow|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
11141256|NCT01822574|FG001|Participant Flow|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
11141257|NCT01822574|FG002|Participant Flow|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
11141258|NCT01822574|OG000|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
11141259|NCT01822574|OG001|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
11141260|NCT01822574|OG002|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
11141261|NCT01822574|EG000|Reported Event|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
11141262|NCT01822574|EG001|Reported Event|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
11141263|NCT01822574|EG002|Reported Event|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
11141264|NCT01822587|BG000|Baseline|Placebo|"Administered once orally following cue exposure on each of the first two days of testing.~Placebo"
11141265|NCT01822587|BG001|Baseline|Propranolol 40mg|"Administered once orally following cue exposure on each of the first two days of testing.~Propranolol, 40 mg"
11141266|NCT01822587|BG002|Baseline|Propranolol, 80mg|"Administered once orally following cue exposure on each of the first two days of testing.~Propranolol, 80 mg"
11141267|NCT01822587|BG003|Baseline|Total|Total of all reporting groups
11141268|NCT01822587|FG000|Participant Flow|Placebo|"Administered once orally following cue exposure on each of the first two days of testing.~Placebo"
11141269|NCT01822587|FG001|Participant Flow|Propranolol 40mg|"Administered once orally following cue exposure on each of the first two days of testing.~Propranolol, 40 mg"
11141270|NCT01822587|FG002|Participant Flow|Propranolol, 80mg|"Administered once orally following cue exposure on each of the first two days of testing.~Propranolol, 80 mg"
11141271|NCT01822587|OG000|Outcome|Placebo|"Administered once orally following cue exposure on each of the first two days of testing.~Placebo"
11141272|NCT01822587|OG001|Outcome|Propranolol 40mg|"Administered once orally following cue exposure on each of the first two days of testing.~Propranolol, 40 mg"
11141273|NCT01822587|OG002|Outcome|Propranolol, 80mg|"Administered once orally following cue exposure on each of the first two days of testing.~Propranolol, 80 mg"
11141274|NCT01822587|EG000|Reported Event|Placebo|"Administered once orally following cue exposure on each of the first two days of testing.~Placebo"
11141275|NCT01822587|EG001|Reported Event|Propranolol 40mg|"Administered once orally following cue exposure on each of the first two days of testing.~Propranolol, 40 mg"
11141276|NCT01822587|EG002|Reported Event|Propranolol, 80mg|"Administered once orally following cue exposure on each of the first two days of testing.~Propranolol, 80 mg"
11141277|NCT01822665|BG000|Baseline|All Randomized Participants|All randomized participants in the study who took at least one treatment dose.
11141278|NCT01822665|FG000|Participant Flow|Overall Study|This was a randomized, 4-way crossover study. Participants received two fast dissolving paracetamol tablets (500 milligrams [mg]/tablet) four times daily (QID); two liquid-filled gelatin capsules containing ibuprofen (200 mg/capsule), three times daily (TID); two ibuprofen tablets (200 mg/tablet), TID; and, two fast dissolving placebo tablets QID. All the treatments were administered orally with water. There was a washout period of 7 days following every treatment session.
11141279|NCT01822665|OG000|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) was administered QID, orally with water.
11141280|NCT01822665|OG001|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), was administered TID, orally with water.
11141281|NCT01822665|OG000|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
11141282|NCT01822665|OG001|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
11141283|NCT01822665|OG002|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
11141284|NCT01822665|OG003|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
11141285|NCT01822665|OG002|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
11141286|NCT01822665|OG000|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
11141287|NCT01822665|OG001|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
11141288|NCT01822665|OG002|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
11141289|NCT01822665|OG001|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
11141290|NCT01822665|OG002|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablet (400 mg/tablet), were administered TID, orally with water.
11141291|NCT01822665|EG000|Reported Event|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
11141292|NCT01822665|EG001|Reported Event|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
11141293|NCT01822665|EG002|Reported Event|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
11141294|NCT01822665|EG003|Reported Event|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
11141295|NCT01822678|BG000|Baseline|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
11141296|NCT01822678|BG001|Baseline|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
11141297|NCT01822678|BG002|Baseline|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
11141298|NCT01822678|BG003|Baseline|Total|Total of all reporting groups
11141299|NCT01822678|FG000|Participant Flow|ESL 800 mg|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
11141300|NCT01822678|FG001|Participant Flow|ESL 600 mg|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
11141301|NCT01822678|FG002|Participant Flow|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
11141302|NCT01822678|OG000|Outcome|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
11141303|NCT01822678|OG001|Outcome|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
11141304|NCT01822678|OG002|Outcome|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
11141305|NCT01822678|EG000|Reported Event|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
11141306|NCT01822678|EG001|Reported Event|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
11141307|NCT01822678|EG002|Reported Event|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
11141308|NCT01822691|BG000|Baseline|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
11141309|NCT01822691|FG000|Participant Flow|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
11141310|NCT01822691|OG000|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
11141311|NCT01822691|EG000|Reported Event|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
11141312|NCT01822756|BG000|Baseline|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
11141313|NCT01822756|BG001|Baseline|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
11141314|NCT01822756|BG002|Baseline|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
11141315|NCT01822756|BG003|Baseline|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
11141316|NCT01822756|BG004|Baseline|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
11141317|NCT01822756|BG005|Baseline|Total|Total of all reporting groups
11141318|NCT01822756|FG000|Participant Flow|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
11141319|NCT01822756|FG001|Participant Flow|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
11141320|NCT01822756|FG002|Participant Flow|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
11141321|NCT01822756|FG003|Participant Flow|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
11141322|NCT01822756|FG004|Participant Flow|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
11141323|NCT01822756|OG000|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
11141324|NCT01822756|OG001|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
11141325|NCT01822756|OG002|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
11141326|NCT01822756|OG003|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
11141327|NCT01822756|OG004|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
11141328|NCT01822756|EG000|Reported Event|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
11141329|NCT01822756|EG001|Reported Event|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
11141330|NCT01822756|EG002|Reported Event|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
11141331|NCT01822756|EG003|Reported Event|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
11141332|NCT01822756|EG004|Reported Event|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
11141333|NCT01822821|BG000|Baseline|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
11141334|NCT01822821|BG001|Baseline|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
11141335|NCT01822821|BG002|Baseline|Total|Total of all reporting groups
11141336|NCT01822821|FG000|Participant Flow|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
11141337|NCT01822821|FG001|Participant Flow|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
11141338|NCT01822821|OG000|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
11141339|NCT01822821|OG001|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
11141340|NCT01822821|EG000|Reported Event|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
11141341|NCT01822821|EG001|Reported Event|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
11141342|NCT01822886|BG000|Baseline|Romidepsin, Gemcitabine|"Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD~Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD."
11141343|NCT01822886|FG000|Participant Flow|Romidepsin, Gemcitabine|"Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD (progressioni disease)~Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD."
11141344|NCT01822886|OG000|Outcome|Romidepsin, Gemcitabine|"Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD~Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD."
11141345|NCT01822886|EG000|Reported Event|Romidepsin, Gemcitabine|"Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD~Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD."
11141346|NCT01822899|BG000|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
11141347|NCT01822899|BG001|Baseline|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
11141348|NCT01822899|BG002|Baseline|Total|Total of all reporting groups
11141349|NCT01822899|FG000|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
11141350|NCT01822899|FG001|Participant Flow|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
11141351|NCT01822899|OG000|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
11141352|NCT01822899|OG001|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
11141353|NCT01822899|EG000|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
11141354|NCT01822899|EG001|Reported Event|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
11141355|NCT01822925|BG000|Baseline|Placebo|Placebo oral tablets three (3) times per day.
11141356|NCT01822925|BG001|Baseline|300 mg DA-9801|Oral tablets three (3) times per day for total daily doses of 300 mg
11141357|NCT01822925|BG002|Baseline|600 mg DA-9801|Oral tablets three (3) times per day for total daily doses of 600 mg
11141358|NCT01822925|BG003|Baseline|900 mg DA-9801|Oral tablets three (3) times per day for total daily doses of 900 mg
11141359|NCT01822925|BG004|Baseline|Total|Total of all reporting groups
11141360|NCT01822925|FG000|Participant Flow|Placebo|Placebo oral tablets three (3) times per day.
11141361|NCT01822925|FG001|Participant Flow|300 mg DA-9801|100 mg oral tablets three (3) times per day for total daily doses of 300 mg
11141362|NCT01822925|FG002|Participant Flow|600 mg DA-9801|200 mg oral tablets three (3) times per day for total daily doses of 600 mg
11141363|NCT01822925|FG003|Participant Flow|900 mg DA-9801|300 mg oral tablets three (3) times per day for total daily doses of 900 mg
11141364|NCT01822925|OG000|Outcome|Placebo|Placebo oral tablets three (3) times per day.
11141365|NCT01822925|OG001|Outcome|300 mg DA-9801|Oral tablets three (3) times per day for total daily doses of 300 mg
11141366|NCT01822925|OG002|Outcome|600 mg DA-9801|Oral tablets three (3) times per day for total daily doses of 600 mg
11141367|NCT01822925|OG003|Outcome|900 mg DA-9801|Oral tablets three (3) times per day for total daily doses of 900 mg
11141368|NCT01822925|EG000|Reported Event|Placebo|Placebo oral tablets three (3) times per day.
11141369|NCT01822925|EG001|Reported Event|300 mg DA-9801|100 mg oral tablets three (3) times per day for total daily doses of 300 mg
11141370|NCT01822925|EG002|Reported Event|600 mg DA-9801|200 mg oral tablets three (3) times per day for total daily doses of 600 mg
11141371|NCT01822925|EG003|Reported Event|900 mg DA-9801|300 mg oral tablets three (3) times per day for total daily doses of 900 mg
11141372|NCT01823107|BG000|Baseline|Meso BioMatrix Acellular Peritoneum Matrix|All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
11141373|NCT01823107|FG000|Participant Flow|Meso BioMatrix Acellular Peritoneum Matrix|All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
11141374|NCT01823107|OG000|Outcome|Meso BioMatrix Acellular Peritoneum Matrix|All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
11141375|NCT01823107|EG000|Reported Event|Meso BioMatrix Acellular Peritoneum Matrix|All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
11141376|NCT01823146|BG000|Baseline|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
11141377|NCT01823146|BG001|Baseline|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN)
11141378|NCT01823146|BG002|Baseline|Total|Total of all reporting groups
11141379|NCT01823146|FG000|Participant Flow|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
11141380|NCT01823146|FG001|Participant Flow|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
11141381|NCT01823146|OG000|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
11141382|NCT01823146|OG001|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
11141383|NCT01823146|EG000|Reported Event|Oxytocin Spray|"single dose of 24 IU oxytocin, self-administered intranasally (IN)~Oxytocin spray: single dose of 24 IU oxytocin, self-administered intranasally (IN)"
11141384|NCT01823146|EG001|Reported Event|Placebo Spray|"single dose of 24 IU saline, self-administered intranasally (IN)~Placebo spray: single dose of 24 IU saline, self-administered intranasally (IN)"
11141385|NCT01823224|BG000|Baseline|Group 1|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg~IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
11141386|NCT01823224|BG001|Baseline|Group 2|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.~2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
11141387|NCT01823224|BG002|Baseline|Total|Total of all reporting groups
11141388|NCT01823224|FG000|Participant Flow|"IV Acetaminophen 1000mg + 2 Oral Sugar Pills"|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg~IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
11141389|NCT01823224|FG001|Participant Flow|"Oral Acetaminophen 2 Capsules + IV Salt Water"|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.~2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
11141390|NCT01823224|OG000|Outcome|Group 1|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times.
11141391|NCT01823224|OG001|Outcome|Group 2|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times. There were no significant differences between the groups over time, Wilks' Lambda (P = 0.875). (Table 4 and Figure 1)
11141392|NCT01823224|OG000|Outcome|Group 1|This group consisted of 28 subjects' data that was analyzed. Of the 28 there were 7 males 21 females.
11141393|NCT01823224|OG001|Outcome|Group 2|This group consisted of 22 subjects that received the oral acetaminophen and IV placebo. Of the 22 there was 1 male and 21 female.
11141394|NCT01823224|EG000|Reported Event|Group 1|.Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen
11141395|NCT01823224|EG001|Reported Event|Group 2|No adverse events
11141396|NCT01823289|BG000|Baseline|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
11141397|NCT01823289|FG000|Participant Flow|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
11141398|NCT01823289|OG000|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
11141399|NCT01823289|EG000|Reported Event|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
11141400|NCT01823328|BG000|Baseline|Ketamine|"Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).~Ketamine: Subjects will receive ketamine for sedation prior to rapid sequence intubation."
11141401|NCT01823328|BG001|Baseline|Etomidate|"Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).~Etomidate: Subjects will receive etomidate for sedation prior to rapid sequence intubation."
11141402|NCT01823328|BG002|Baseline|Total|Total of all reporting groups
11141403|NCT01823328|FG000|Participant Flow|Ketamine|"Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).~Ketamine: Subjects will receive ketamine for sedation prior to rapid sequence intubation."
11141404|NCT01823328|FG001|Participant Flow|Etomidate|"Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).~Etomidate: Subjects will receive etomidate for sedation prior to rapid sequence intubation."
11141405|NCT01823328|OG000|Outcome|Ketamine|"Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).~Ketamine: Subjects will receive ketamine for sedation prior to rapid sequence intubation."
11141406|NCT01823328|OG001|Outcome|Etomidate|"Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).~Etomidate: Subjects will receive etomidate for sedation prior to rapid sequence intubation."
11141407|NCT01823328|EG000|Reported Event|Ketamine|"Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).~Ketamine: Subjects will receive ketamine for sedation prior to rapid sequence intubation."
11141408|NCT01823328|EG001|Reported Event|Etomidate|"Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).~Etomidate: Subjects will receive etomidate for sedation prior to rapid sequence intubation."
11141409|NCT01823341|BG000|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11141410|NCT01823341|FG000|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11141411|NCT01823341|OG000|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
11141412|NCT01823341|OG001|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
11141413|NCT01823341|OG002|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
11141414|NCT01823341|OG003|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
11141415|NCT01823341|EG000|Reported Event|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
11141416|NCT01823497|BG000|Baseline|Parent/Nurse Controlled Analgesia|"Parent/Nurse Controlled Analgesia will be the method of morphine delivery.~Morphine: Morphine will be used to control pain post-surgery."
11141417|NCT01823497|BG001|Baseline|Continuous Opioid Infusion|"Continuous Opioid Infusion will be the method used to deliver morphine to group 2~Morphine: Morphine will be used to control pain post-surgery."
11141418|NCT01823497|BG002|Baseline|Total|Total of all reporting groups
11141419|NCT01823497|FG000|Participant Flow|Parent/Nurse Controlled Analgesia|"Parent/Nurse Controlled Analgesia will be the method of morphine delivery.~Morphine: Morphine will be used to control pain post-surgery."
11141420|NCT01823497|FG001|Participant Flow|Continuous Opioid Infusion|"Continuous Opioid Infusion will be the method used to deliver morphine to group 2~Morphine: Morphine will be used to control pain post-surgery."
11141421|NCT01823497|OG000|Outcome|Parent/Nurse Controlled Analgesia|"Parent/Nurse Controlled Analgesia will be the method of morphine delivery.~Morphine: Morphine will be used to control pain post-surgery."
11141422|NCT01823497|OG001|Outcome|Continuous Opioid Infusion|"Continuous Opioid Infusion will be the method used to deliver morphine to group 2~Morphine: Morphine will be used to control pain post-surgery."
11141423|NCT01823497|EG000|Reported Event|Parent/Nurse Controlled Analgesia|"Parent/Nurse Controlled Analgesia will be the method of morphine delivery.~Morphine: Morphine will be used to control pain post-surgery."
11141424|NCT01823497|EG001|Reported Event|Continuous Opioid Infusion|"Continuous Opioid Infusion will be the method used to deliver morphine to group 2~Morphine: Morphine will be used to control pain post-surgery."
11141425|NCT01823510|BG000|Baseline|Type 2 Diabetic Patients|"All participants receive both Ticagrelor and Clopidogrel (each with aspirin) in a cross-over design. Treatment sequence (Tica-Clop OR Clop-Tica) was randomly assigned and with a 2-week washout period in between (i.e., Tica/Clop (5-7 days), Washout (14 days), and Clop/Tica (5-7 days))."
11141426|NCT01823510|FG000|Participant Flow|Tica-Clop|Participants received Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days).
11141427|NCT01823510|FG001|Participant Flow|Clop-Tica|Participants received Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days).
11141428|NCT01823510|OG000|Outcome|Ticagrelor + Aspirin|Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
11141429|NCT01823510|OG001|Outcome|Clopidogrel + Aspirin|Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
11141430|NCT01823510|EG000|Reported Event|Ticagrelor + Aspirin|Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
11141431|NCT01823510|EG001|Reported Event|Clopidrogel + Aspirin|Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
11141432|NCT01823536|BG000|Baseline|MenACWY-CRM_2 (≥7-≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
11141433|NCT01823536|BG001|Baseline|MenACWY-CRM_1 (≥7-≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
11141434|NCT01823536|BG002|Baseline|Vaccine Naive (≥7-≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
11141435|NCT01823536|BG003|Baseline|MenACWY-CRM_1 (≥11-≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
11141436|NCT01823536|BG004|Baseline|Vaccine Naive (≥11-≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
11141437|NCT01823536|BG005|Baseline|Not Assigned|"Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate not assigned group in the FAS and excluded from the PPS. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7-≤10 Years) group in the extension study."
11141438|NCT01823536|BG006|Baseline|Total|Total of all reporting groups
11141439|NCT01823536|FG000|Participant Flow|MenACWY-CRM_2 (≥7-≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
11141440|NCT01823536|FG001|Participant Flow|MenACWY-CRM_1 (≥7-≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
11141441|NCT01823536|FG002|Participant Flow|Vaccine Naive (≥7-≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
11141442|NCT01823536|FG003|Participant Flow|MenACWY-CRM_1 (≥11-≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
11141443|NCT01823536|FG004|Participant Flow|Vaccine Naive (≥11-≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
11141444|NCT01823536|FG005|Participant Flow|Not Assigned|"Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate not assigned group in the Full Analysis Set and excluded from the Per Protocol Set. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7-≤10 Years) group in the extension study."
11141445|NCT01823536|OG000|Outcome|MenACWY-CRM_2 (≥7-≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
11141446|NCT01823536|OG001|Outcome|MenACWY-CRM_1 (≥7-≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
11141447|NCT01823536|OG002|Outcome|MenACWY-CRM_1 (≥11-≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
11141448|NCT01823536|OG002|Outcome|Vaccine Naive (≥7-≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
11141449|NCT01823536|OG003|Outcome|MenACWY-CRM_1 (≥11-≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
11141450|NCT01823536|OG004|Outcome|Vaccine Naive (≥11-≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
11141451|NCT01823536|EG000|Reported Event|MenACWY-CRM_2 (≥7-≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
11141452|NCT01823536|EG001|Reported Event|MenACWY-CRM_1 (≥7-≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
11141453|NCT01823536|EG002|Reported Event|Vaccine Naive (≥7-≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
11141454|NCT01823536|EG003|Reported Event|MenACWY-CRM_1 (≥11-≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
11141455|NCT01823536|EG004|Reported Event|Vaccine Naive (≥11-≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
11141456|NCT01823614|BG000|Baseline|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
11141457|NCT01823614|BG001|Baseline|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
11141458|NCT01823614|BG002|Baseline|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
11141459|NCT01823614|BG003|Baseline|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
11141460|NCT01823614|BG004|Baseline|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
11141461|NCT01823614|BG005|Baseline|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
11141462|NCT01823614|BG006|Baseline|Total|Total of all reporting groups
11141463|NCT01823614|FG000|Participant Flow|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
11141464|NCT01823614|FG001|Participant Flow|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
11141465|NCT01823614|FG002|Participant Flow|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
11141466|NCT01823614|FG003|Participant Flow|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
11141467|NCT01823614|FG004|Participant Flow|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
11141468|NCT01823614|FG005|Participant Flow|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
11141469|NCT01823614|OG000|Outcome|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
11141470|NCT01823614|OG001|Outcome|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
11141471|NCT01823614|OG002|Outcome|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
11141472|NCT01823614|OG003|Outcome|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
11141473|NCT01823614|OG004|Outcome|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
11141474|NCT01823614|OG005|Outcome|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
11141475|NCT01823614|OG000|Outcome|CD4 Cell Count > 500|Group which contains patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
11141476|NCT01823614|OG001|Outcome|CD4 Cell Count 350-500|Group which contains patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
11141477|NCT01823614|OG002|Outcome|CD4 Cell Count < 350|Group which contains patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
11141478|NCT01823614|OG000|Outcome|CD4 Cell Count > 500|Group which contains naive patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
11141479|NCT01823614|OG001|Outcome|CD4 Cell Count 350-500|Group which contains naive patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
11141480|NCT01823614|OG002|Outcome|CD4 Cell Count < 350|Group which contains naive patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
11141481|NCT01823614|EG000|Reported Event|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
11141482|NCT01823614|EG001|Reported Event|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
11141483|NCT01823614|EG002|Reported Event|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
11141484|NCT01823614|EG003|Reported Event|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
11141485|NCT01823614|EG004|Reported Event|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
11141486|NCT01823614|EG005|Reported Event|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
11141487|NCT01823653|BG000|Baseline|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
11141488|NCT01823653|FG000|Participant Flow|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
11141489|NCT01823653|OG000|Outcome|Treated Thigh|Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)
11141490|NCT01823653|OG001|Outcome|Control Thigh|Each subject's own thigh untreated during study
11141491|NCT01823653|OG000|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
11141492|NCT01823653|OG000|Outcome|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
11141493|NCT01823653|EG000|Reported Event|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
11141494|NCT01823679|BG000|Baseline|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
11141495|NCT01823679|FG000|Participant Flow|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
11141496|NCT01823679|OG000|Outcome|Capecitabine 1000 mg/m²|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
11141497|NCT01823679|OG000|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
11141498|NCT01823679|EG000|Reported Event|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
11141499|NCT01823835|BG000|Baseline|Phase Ia - Cohort 1|100 mg GDC-0810 once daily (QD) in fasting state.
11141500|NCT01823835|BG001|Baseline|Phase Ia - Cohort 2|200 mg GDC-0810 QD in fasting state.
11141501|NCT01823835|BG002|Baseline|Phase Ia - Cohort 3|400 mg GDC-0810 QD in fasting state.
11141502|NCT01823835|BG003|Baseline|Phase Ia - Cohort 4|600 mg GDC-0810 QD in fasting state.
11141503|NCT01823835|BG004|Baseline|Phase Ia - Cohort 5|600 mg GDC-0810 QD in non-fasting state.
11141504|NCT01823835|BG005|Baseline|Phase Ia - Cohort 6|300 mg GDC-0810 twice daily (BID) in fasting state.
11141505|NCT01823835|BG006|Baseline|Phase Ia - Cohort 7|800 mg GDC-0810 QD in fasting state.
11141506|NCT01823835|BG007|Baseline|Phase Ia - Cohort 8|800 mg GDC-0810 QD in non-fasting state.
11141507|NCT01823835|BG008|Baseline|Phase Ia - Cohort 9|400 mg GDC-0810 BID in fasting state.
11141508|NCT01823835|BG009|Baseline|Phase IIa - Cohort A1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
11141509|NCT01823835|BG010|Baseline|Phase IIa - Cohort A2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
11141510|NCT01823835|BG011|Baseline|Phase IIa - Cohort B1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
11141511|NCT01823835|BG012|Baseline|Phase IIa - Cohort B2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
11141512|NCT01823835|BG013|Baseline|Phase Ib - Cohort C1|400 mg GDC-0810 + 125 mg Palbociclib QD.
11141513|NCT01823835|BG014|Baseline|Phase Ib - Cohort D1|≤600 mg GDC-0810 QD + LHRH agonist once monthly.
11141514|NCT01823835|BG015|Baseline|Total|Total of all reporting groups
11141515|NCT01823835|FG000|Participant Flow|Phase Ia - Cohort 1|100 mg GDC-0810 once daily (QD) in fasting state.
11141516|NCT01823835|FG001|Participant Flow|Phase Ia - Cohort 2|200 mg GDC-0810 QD in fasting state.
11141517|NCT01823835|FG002|Participant Flow|Phase Ia - Cohort 3|400 mg GDC-0810 QD in fasting state.
11141518|NCT01823835|FG003|Participant Flow|Phase Ia - Cohort 4|600 mg GDC-0810 QD in fasting state.
11141519|NCT01823835|FG004|Participant Flow|Phase Ia - Cohort 5|600 mg GDC-0810 QD in non-fasting state.
11141520|NCT01823835|FG005|Participant Flow|Phase Ia - Cohort 6|300 mg GDC-0810 twice daily (BID) in fasting state.
11141521|NCT01823835|FG006|Participant Flow|Phase Ia - Cohort 7|800 mg GDC-0810 QD in fasting state.
11141522|NCT01823835|FG007|Participant Flow|Phase Ia - Cohort 8|800 mg GDC-0810 QD in non-fasting state.
11141523|NCT01823835|FG008|Participant Flow|Phase Ia - Cohort 9|400 mg GDC-0810 BID in fasting state.
11141524|NCT01823835|FG009|Participant Flow|Phase IIa - Cohort A1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
11141525|NCT01823835|FG010|Participant Flow|Phase IIa - Cohort A2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
11141526|NCT01823835|FG011|Participant Flow|Phase IIa - Cohort B1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
11141527|NCT01823835|FG012|Participant Flow|Phase IIa - Cohort B2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
11141528|NCT01823835|FG013|Participant Flow|Phase Ib - Cohort C1|400 mg GDC-0810 + 125 mg Palbociclib QD.
11141529|NCT01823835|FG014|Participant Flow|Phase Ib - Cohort D1|≤600 mg GDC-0810 QD + LHRH agonist once monthly.
11141530|NCT01823835|OG000|Outcome|Phase Ia - All Cohorts|GDC-0810 single agent was administered orally on a continuous daily dosing regimen
11141531|NCT01823835|OG000|Outcome|Phase IIa - Cohort A1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
11141532|NCT01823835|OG001|Outcome|Phase IIa - Cohort A2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
11141533|NCT01823835|OG002|Outcome|Phase IIa - Cohort B1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
11141534|NCT01823835|OG003|Outcome|Phase IIa - Cohort B2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
11141535|NCT01823835|OG000|Outcome|Phase Ib - Cohort C1|400 mg GDC-0810 + 125 mg Palbociclib QD.
11141536|NCT01823835|OG001|Outcome|Phase Ib - Cohort D1|≤600 mg GDC-0810 QD + LHRH agonist once monthly.
11141537|NCT01823835|OG000|Outcome|Phase Ia - Cohort 1|100 mg GDC-0810 once daily (QD) in fasting state.
11141538|NCT01823835|OG001|Outcome|Phase Ia - Cohort 2|200 mg GDC-0810 QD in fasting state.
11141539|NCT01823835|OG002|Outcome|Phase Ia - Cohort 3|400 mg GDC-0810 QD in fasting state.
11141540|NCT01823835|OG003|Outcome|Phase Ia - Cohort 4|600 mg GDC-0810 QD in fasting state.
11141541|NCT01823835|OG004|Outcome|Phase Ia - Cohort 5|600 mg GDC-0810 QD in non-fasting state.
11141542|NCT01823835|OG005|Outcome|Phase Ia - Cohort 6|300 mg GDC-0810 twice daily (BID) in fasting state.
11141543|NCT01823835|OG006|Outcome|Phase Ia - Cohort 7|800 mg GDC-0810 QD in fasting state.
11141544|NCT01823835|OG007|Outcome|Phase Ia - Cohort 8|800 mg GDC-0810 QD in non-fasting state.
11141545|NCT01823835|OG008|Outcome|Phase Ia - Cohort 9|400 mg GDC-0810 BID in fasting state.
11141546|NCT01823835|OG009|Outcome|Phase IIa - Cohort A1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
11141547|NCT01823835|OG010|Outcome|Phase IIa - Cohort A2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
11141548|NCT01823835|OG011|Outcome|Phase IIa - Cohort B1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
11141549|NCT01823835|OG012|Outcome|Phase IIa - Cohort B2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
11141550|NCT01823835|OG013|Outcome|Phase Ib - Cohort C1|400 mg GDC-0810 + 125 mg Palbociclib QD.
11141551|NCT01823835|OG014|Outcome|Phase Ib - Cohort D1|≤600 mg GDC-0810 QD + LHRH agonist once monthly.
11141552|NCT01823835|OG000|Outcome|Phase Ib - Cohort D1|≤600 mg GDC-0810 QD + LHRH agonist once monthly.
11141553|NCT01823835|EG000|Reported Event|Phase Ia - Cohort 1|100 mg GDC-0810 once daily (QD) in fasting state.
11141554|NCT01823835|EG001|Reported Event|Phase Ia - Cohort 2|200 mg GDC-0810 QD in fasting state.
11141555|NCT01823835|EG002|Reported Event|Phase Ia - Cohort 3|400 mg GDC-0810 QD in fasting state.
11141556|NCT01823835|EG003|Reported Event|Phase Ia - Cohort 4|600 mg GDC-0810 QD in fasting state.
11141557|NCT01823835|EG004|Reported Event|Phase Ia - Cohort 5|600 mg GDC-0810 QD in non-fasting state.
11141558|NCT01823835|EG005|Reported Event|Phase Ia - Cohort 6|300 mg GDC-0810 twice daily (BID) in fasting state.
11141559|NCT01823835|EG006|Reported Event|Phase Ia - Cohort 7|800 mg GDC-0810 QD in fasting state.
11141560|NCT01823835|EG007|Reported Event|Phase Ia - Cohort 8|800 mg GDC-0810 QD in non-fasting state.
11141561|NCT01823835|EG008|Reported Event|Phase Ia - Cohort 9|400 mg GDC-0810 BID in fasting state.
11141562|NCT01823835|EG009|Reported Event|Phase IIa - Cohort A1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
11141563|NCT01823835|EG010|Reported Event|Phase IIa - Cohort A2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
11141564|NCT01823835|EG011|Reported Event|Phase IIa - Cohort B1|600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
11141565|NCT01823835|EG012|Reported Event|Phase IIa - Cohort B2|600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
11141566|NCT01823835|EG013|Reported Event|Phase Ib - Cohort C1|400 mg GDC-0810 + 125 mg Palbociclib QD.
11141567|NCT01823835|EG014|Reported Event|Phase Ib - Cohort D1|≤600 mg GDC-0810 QD + LHRH agonist once monthly.
11141568|NCT01823861|BG000|Baseline|Mobile Phone-based Intervention|"Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.~Mobile phone-based intervention: Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message."
11141569|NCT01823861|BG001|Baseline|Standard Care|Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.
11141570|NCT01823861|BG002|Baseline|Total|Total of all reporting groups
11141571|NCT01823861|FG000|Participant Flow|Mobile Phone-based Intervention|"Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.~Mobile phone-based intervention: Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message."
11141572|NCT01823861|FG001|Participant Flow|Standard Care|Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.
11141573|NCT01823861|OG000|Outcome|Mobile Phone-based Intervention|"Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.~Mobile phone-based intervention: Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message."
11141574|NCT01823861|OG001|Outcome|Standard Care|Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.
11149769|NCT01873417|FG000|Participant Flow|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
11141575|NCT01823861|EG000|Reported Event|Mobile Phone-based Intervention|"Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.~Mobile phone-based intervention: Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message."
11141576|NCT01823861|EG001|Reported Event|Standard Care|Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.
11141577|NCT01823991|BG000|Baseline|COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID)|"Participants will be provided with two bottles containing Lovaza (or placebo) and VitaBlue (or placebo). Participants will be asked to take 1 tablet of Lovaza (or placebo) two times a day and 1 tablet of VitaBlue (or placebo) three times a day.~VitaBlue™: Self administration of nutritional supplement COGNUTRIN for 3 months.~The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.~Lovaza®: Self administration of nutritional supplement COGNUTRIN for 3 months.~The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza."
11141578|NCT01823991|BG001|Baseline|Matching Placebo BID|"Participants will be provided with two bottles containing Lovaza (or placebo) and VitaBlue (or placebo). Participants will be asked to take 1 tablet of Lovaza (or placebo) two times a day and 1 tablet of VitaBlue (or placebo) three times a day.~Placebo: Self administration of placebo for 3 months.~Investigators use a placebo to make sure that it really is the study medicine that is making a difference in the participant's condition. It does not have anything in it that would normally help or harm most people."
11141579|NCT01823991|BG002|Baseline|Total|Total of all reporting groups
11141580|NCT01823991|FG000|Participant Flow|COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID)|"Participants will be provided with two bottles containing Lovaza and VitaBlue. Participants will be asked to take 1 tablet of Lovaza two times a day and 1 tablet of VitaBlue three times a day.~VitaBlue™: Self administration of nutritional supplement COGNUTRIN for 3 months.~The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.~Lovaza®: Self administration of nutritional supplement COGNUTRIN for 3 months.~The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza."
11141581|NCT01823991|FG001|Participant Flow|Matching Placebo BID|"Participants will be provided with two bottles containing placebos. Participants will be asked to take 1 tablet of placebo two times a day and 1 tablet of or placebo three times a day.~Placebo: Self administration of placebo for 3 months.~Investigators use a placebo to make sure that it really is the study medicine that is making a difference in the participant's condition. It does not have anything in it that would normally help or harm most people."
11141582|NCT01823991|OG000|Outcome|A - Cognutrin #1|Cognutrin Treatment Time 1
11141583|NCT01823991|OG001|Outcome|B - Cognutrin #2|Cognutrin Time 2.
11141584|NCT01823991|OG002|Outcome|C - Placebo #1|Placebo Time 1.
11141585|NCT01823991|OG003|Outcome|D - Placebo #2|Placebo Time 2.
11141586|NCT01823991|OG000|Outcome|Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)|Self administration of nutritional supplement COGNUTRIN for 3 months.
11141587|NCT01823991|OG001|Outcome|Matching Placebo Twice a Day (BID)|Self administration of placebo for 3 months.
11141588|NCT01823991|EG000|Reported Event|Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)|Self administration of nutritional supplement COGNUTRIN for 3 months.
11141589|NCT01823991|EG001|Reported Event|Matching Placebo Twice a Day (BID)|Self administration of placebo for 3 months.
11141590|NCT01824082|BG000|Baseline|Ropivacaine 0.5%|"Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: normal saline.~Perineural infusion [continuous peripheral nerve block(s)]: Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment solution."
11141591|NCT01824082|BG001|Baseline|Normal Saline (Salt Water) Infusion|"Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of normal saline placebo fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: ropivacaine 0.5%.~Perineural infusion [continuous peripheral nerve block(s)]: Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment solution."
11141592|NCT01824082|BG002|Baseline|Total|Total of all reporting groups
11141593|NCT01824082|FG000|Participant Flow|Ropivacaine 0.5%|"Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: normal saline.~Perineural infusion [continuous peripheral nerve block(s)]: Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment solution."
11141594|NCT01824082|FG001|Participant Flow|Normal Saline (Salt Water) Infusion|"Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of normal saline placebo fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: ropivacaine 0.5%.~Perineural infusion [continuous peripheral nerve block(s)]: Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment solution."
11141595|NCT01824082|OG000|Outcome|Ropivacaine 0.5%|"Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: normal saline.~Perineural infusion [continuous peripheral nerve block(s)]: Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment solution."
11141596|NCT01824082|OG001|Outcome|Normal Saline (Salt Water) Infusion|"Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of normal saline placebo fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: ropivacaine 0.5%.~Perineural infusion [continuous peripheral nerve block(s)]: Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment solution."
11141597|NCT01824082|OG000|Outcome|Ropivacaine 0.5% Only (no Placebo Crossover)|Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of ropivacaine 0.5% from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: normal saline.
11149770|NCT01873417|OG000|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
11149771|NCT01873417|EG000|Reported Event|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
11141598|NCT01824082|OG001|Outcome|Placebo Infusion Only (no Ropivacaine 0.5% Crossover)|Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of normal saline placebo fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: ropivacaine 0.5%.
11141599|NCT01824082|OG002|Outcome|Ropivacaine 0.5% Followed by Placebo Infusion|Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of ropivacaine 0.5% from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). Subjects assigned this treatment returned 4-16 weeks later for a second infusion of the alternate treatment: normal saline.
11141600|NCT01824082|OG003|Outcome|Placebo Followed by Ropivacaine 0.5% Infusion|Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of normal saline placebo fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects in this group returned returned 4-16 weeks later for a second infusion of the alternate treatment: ropivacaine 0.5%.
11141601|NCT01824082|EG000|Reported Event|Ropivacaine 0.5%|Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. This group includes subjects who received the ropivacaine infusion either as the initial treatment or crossover treatment.
11141602|NCT01824082|EG001|Reported Event|Normal Saline (Salt Water) Infusion|Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of normal saline placebo fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. This group includes subjects who received the saline infusion either as the initial treatment or crossover treatment.
11141603|NCT01824160|BG000|Baseline|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
11141604|NCT01824160|FG000|Participant Flow|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
11141605|NCT01824160|OG000|Outcome|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
11141606|NCT01824160|EG000|Reported Event|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
11141607|NCT01824290|BG000|Baseline|Placebo|Period 1: Participants received placebo orally by tablets once a day.
11141608|NCT01824290|BG001|Baseline|Tadalafil|Period 1: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered orally by tablets once a day.
11141609|NCT01824290|BG002|Baseline|Total|Total of all reporting groups
11141610|NCT01824290|FG000|Participant Flow|Placebo|Period 1: Participants received placebo orally by tablets once a day.
11141611|NCT01824290|FG001|Participant Flow|Tadalafil|Period 1: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day.
11141612|NCT01824290|FG002|Participant Flow|Placebo/Tadalafil|"Period 2: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day.~Participants had received placebo during period 1."
11141613|NCT01824290|FG003|Participant Flow|Tadalafil/Tadalafil|"Period 2: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day.~Participants had received tadalafil during period 1."
11141614|NCT01824290|OG000|Outcome|Placebo|Period 1: Participants received placebo orally by tablets once a day.
11141615|NCT01824290|OG001|Outcome|Tadalafil|Period 1: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered orally by tablets once a day.
11141616|NCT01824290|OG000|Outcome|20 mg Tadalafil|Period 1: 20 mg tadalafil administered orally by tablets once a day with concomitant endothelin receptor antagonist (ERA).
11141617|NCT01824290|OG001|Outcome|40 mg Tadalafil|Period 1: 40 mg tadalafil administered orally by tablets once a day with concomitant ERA.
11141618|NCT01824290|OG000|Outcome|Placebo/Tadalafil - Open-Label Treatment|"Period 2: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day.~Participants had received placebo during period 1."
11141619|NCT01824290|OG001|Outcome|Tadalafil/Tadalafil - Open-Label Treatment|"Period 2: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day.~Participants had received tadalafil during period 1."
11141620|NCT01824290|EG000|Reported Event|Placebo - Double Blind|Period 1: Participants received placebo orally by tablets once a day.
11141621|NCT01824290|EG001|Reported Event|Tadalafil - Double Blind|Period 1: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day.
11141622|NCT01824290|EG002|Reported Event|Placebo/Tadalafil - Open-Label Treatment|"Period 2: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day.~Participants had received placebo during period 1."
11141623|NCT01824290|EG003|Reported Event|Tadalafil/Tadalafil - Open-Label Treatment|"Period 2: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day.~Participants had received tadalafil during period 1."
11141624|NCT01824303|BG000|Baseline|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
11141625|NCT01824303|BG001|Baseline|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
11141626|NCT01824303|BG002|Baseline|Total|Total of all reporting groups
11141627|NCT01824303|FG000|Participant Flow|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
11141628|NCT01824303|FG001|Participant Flow|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
11141629|NCT01824303|OG000|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
11141630|NCT01824303|OG001|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
11141631|NCT01824303|EG000|Reported Event|LiRIS 400 mg_Randomized Study|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study.
11141632|NCT01824303|EG001|Reported Event|LiRIS Placebo_Randomized Study|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study.
11141633|NCT01824303|EG002|Reported Event|LiRIS 400 mg_Open Label Extension|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
11141634|NCT01824303|EG003|Reported Event|LiRIS Placebo/LiRIS 400 mg _Open Label Extension|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
11141635|NCT01824342|BG000|Baseline|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
11141636|NCT01824342|BG001|Baseline|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
11141637|NCT01824342|BG002|Baseline|Total|Total of all reporting groups
11141638|NCT01824342|FG000|Participant Flow|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
11141639|NCT01824342|FG001|Participant Flow|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
11141640|NCT01824342|OG000|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
11141641|NCT01824342|OG001|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
11141642|NCT01824342|EG000|Reported Event|Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
11141643|NCT01824342|EG001|Reported Event|Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
11141644|NCT01824355|BG000|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
11141645|NCT01824355|FG000|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:~At least 60% of subjects were younger than 65 years of age.~At least 20% had type 1 diabetes.~At least 50% with type 2 diabetes were insulin users.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
11141646|NCT01824355|OG000|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
11141647|NCT01824355|EG000|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:~At least 60% of subjects were younger than 65 years of age.~At least 20% had type 1 diabetes.~At least 50% with type 2 diabetes were insulin users.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
11141648|NCT01824394|BG000|Baseline|nMARQ® Group|Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
11141649|NCT01824394|BG001|Baseline|THERMOCOOL® Group|Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
11141650|NCT01824394|BG002|Baseline|Roll-in Subjects|Calibration roll-in cohort
11141651|NCT01824394|BG003|Baseline|Total|Total of all reporting groups
11141652|NCT01824394|FG000|Participant Flow|nMARQ® Group|Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
11141653|NCT01824394|FG001|Participant Flow|ThermoCool Group|Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
11141654|NCT01824394|FG002|Participant Flow|Roll-in Subjects|Calibration roll-in cohort
11141655|NCT01824394|OG000|Outcome|nMARQ® Group|Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
11141656|NCT01824394|OG001|Outcome|ThermoCool Group|Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
11141657|NCT01824394|OG002|Outcome|Roll-in Subjects|Calibration roll-in cohort
11141658|NCT01824394|EG000|Reported Event|nMARQ® Group|Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
11141659|NCT01824394|EG001|Reported Event|THERMOCOOL® Group|Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter
11141660|NCT01824394|EG002|Reported Event|Roll-in Subjects|Calibration roll-in cohort
11141661|NCT01824446|BG000|Baseline|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
11141662|NCT01824446|FG000|Participant Flow|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
11141663|NCT01824446|OG000|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
11141664|NCT01824446|EG000|Reported Event|[14C]SSP-004184|
11141665|NCT01824472|BG000|Baseline|CPAP+CC|"CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)~CPAP: Treatment for sleep apnea~CC: Placebo (sham) for insomnia"
11141666|NCT01824472|BG001|Baseline|Sham CPAP+CC|"sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)~sham CPAP: Placebo for sleep apnea~CC: Placebo (sham) for insomnia"
11141667|NCT01824472|BG002|Baseline|CPAP+CBT|"CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia~CPAP: Treatment for sleep apnea~CBT: Treatment for insomnia"
11141668|NCT01824472|BG003|Baseline|Total|Total of all reporting groups
11141669|NCT01824472|FG000|Participant Flow|CPAP+CC|"CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)~CPAP: Treatment for sleep apnea~CC: Placebo (sham) for insomnia"
11141670|NCT01824472|FG001|Participant Flow|Sham CPAP+CC|"sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)~sham CPAP: Placebo for sleep apnea~CC: Placebo (sham) for insomnia"
11141671|NCT01824472|FG002|Participant Flow|CPAP+CBT|"CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia~CPAP: Treatment for sleep apnea~CBT: Treatment for insomnia"
11141672|NCT01824472|OG000|Outcome|CPAP+CC|"CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)~CPAP: Treatment for sleep apnea~CC: Placebo (sham) for insomnia"
11141673|NCT01824472|OG001|Outcome|Sham CPAP+CC|"sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)~sham CPAP: Placebo for sleep apnea~CC: Placebo (sham) for insomnia"
11141674|NCT01824472|OG002|Outcome|CPAP+CBT|"CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia~CPAP: Treatment for sleep apnea~CBT: Treatment for insomnia"
11141675|NCT01824472|EG000|Reported Event|CPAP+CC|"CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)~CPAP: Treatment for sleep apnea~CC: Placebo (sham) for insomnia"
11141676|NCT01824472|EG001|Reported Event|Sham CPAP+CC|"sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)~sham CPAP: Placebo for sleep apnea~CC: Placebo (sham) for insomnia"
11141677|NCT01824472|EG002|Reported Event|CPAP+CBT|"CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia~CPAP: Treatment for sleep apnea~CBT: Treatment for insomnia"
11141678|NCT01824498|BG000|Baseline|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141679|NCT01824498|BG001|Baseline|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141680|NCT01824498|BG002|Baseline|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141681|NCT01824498|BG003|Baseline|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141682|NCT01824498|BG004|Baseline|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141683|NCT01824498|BG005|Baseline|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141684|NCT01824498|BG006|Baseline|Total|Total of all reporting groups
11141685|NCT01824498|FG000|Participant Flow|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141686|NCT01824498|FG001|Participant Flow|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141687|NCT01824498|FG002|Participant Flow|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141688|NCT01824498|FG003|Participant Flow|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141689|NCT01824498|FG004|Participant Flow|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141690|NCT01824498|FG005|Participant Flow|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
11141691|NCT01824498|OG000|Outcome|High Fat Diet|Hig fat diet = 40% fat
11141692|NCT01824498|OG001|Outcome|Low Fat Diet|Low fat diet = 20% fat
11141693|NCT01824498|OG002|Outcome|Low Fat, High n3 Diet|Low fat, n3 diet = 20% fat + 3% n3
11141694|NCT01824498|EG000|Reported Event|High Fat Diet|High fat diet = 40% fat
11141695|NCT01824498|EG001|Reported Event|Low Fat Diet|Low fat diet = 20% fat
11141696|NCT01824498|EG002|Reported Event|Low Fat, High n3 Diet|Low fat, high n3 diet = 20% fat + 3% n3
11141697|NCT01824576|BG000|Baseline|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
11141698|NCT01824576|FG000|Participant Flow|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
11141699|NCT01824576|OG000|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
11141700|NCT01824576|EG000|Reported Event|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
11141701|NCT01824589|BG000|Baseline|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
11141702|NCT01824589|BG001|Baseline|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
11141703|NCT01824589|BG002|Baseline|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
11141704|NCT01824589|BG003|Baseline|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
11141705|NCT01824589|BG004|Baseline|Total|Total of all reporting groups
11141706|NCT01824589|FG000|Participant Flow|Group A|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg.~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
11141707|NCT01824589|FG001|Participant Flow|Group B|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg.~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
11141708|NCT01824589|FG002|Participant Flow|Group C|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg.~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
11141709|NCT01824589|FG003|Participant Flow|Group D|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg.~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
11141710|NCT01824589|OG000|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
11141711|NCT01824589|OG001|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
11141712|NCT01824589|OG002|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
11141713|NCT01824589|OG003|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
11141714|NCT01824589|EG000|Reported Event|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
11141715|NCT01824589|EG001|Reported Event|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
11141716|NCT01824589|EG002|Reported Event|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
11141717|NCT01824589|EG003|Reported Event|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
11141718|NCT01824602|BG000|Baseline|Group 4: Placebo|"Placebo pills~Placebo : Placebo sugar pills"
11141719|NCT01824602|BG001|Baseline|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg~Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
11141720|NCT01824602|BG002|Baseline|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg~Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
11141721|NCT01824602|BG003|Baseline|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg~Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
11141722|NCT01824602|BG004|Baseline|Total|Total of all reporting groups
11141723|NCT01824602|FG000|Participant Flow|Group 4: Placebo|"Placebo pills~Placebo : Placebo sugar pills"
11141724|NCT01824602|FG001|Participant Flow|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg~Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
11141725|NCT01824602|FG002|Participant Flow|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg~Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
11141726|NCT01824602|FG003|Participant Flow|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg~Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
11141727|NCT01824602|OG000|Outcome|Placebo|ITT Population
11141728|NCT01824602|OG001|Outcome|ESL 600 mg|ITT Population
11141729|NCT01824602|OG002|Outcome|ESL 1200 mg|ITT Population
11141730|NCT01824602|OG003|Outcome|ESL 1800 mg|(ITT Population
11141731|NCT01824602|EG000|Reported Event|Placebo|Safety Population
11141732|NCT01824602|EG001|Reported Event|ESL 600 mg|Safety Population
11141733|NCT01824602|EG002|Reported Event|ESL 1200 mg|Safety Population
11141734|NCT01824602|EG003|Reported Event|ESL 1800 mg|Safety Population
11141735|NCT01824693|BG000|Baseline|Arm I (Busulfan, Cyclophosphamide, Melphalan)|"CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1.~TRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy.~Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT~Busulfan: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given IV or PO~Pharmacological Study: Correlative studies~Tacrolimus: Given IV or PO"
11141736|NCT01824693|BG001|Baseline|Arm II (Busulfan, Fludarabine Phosphate)|"CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2.~TRANSPLANT: Patients undergo allogeneic HCT as in Arm I.~Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT~Busulfan: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Pharmacological Study: Correlative studies~Tacrolimus: Given IV or PO"
11141737|NCT01824693|BG002|Baseline|ARM III (Non-Randomized)|Patients who were not randomized and did not proceed to transplant because they did not meet all the protocol requirement for randomization
11141738|NCT01824693|BG003|Baseline|Total|Total of all reporting groups
11149772|NCT01873495|BG000|Baseline|Omacetaxine: Consolidation/Maintenance|"Omacetaxine: Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.~Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles"
11141739|NCT01824693|FG000|Participant Flow|Arm I (Busulfan, Cyclophosphamide, Melphalan)|"CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1.~TRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy.~Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT~Busulfan: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given IV or PO~Pharmacological Study: Correlative studies~Tacrolimus: Given IV or PO"
11141740|NCT01824693|FG001|Participant Flow|Arm II (Busulfan, Fludarabine Phosphate)|"CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2.~TRANSPLANT: Patients undergo allogeneic HCT as in Arm I.~Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT~Busulfan: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Pharmacological Study: Correlative studies~Tacrolimus: Given IV or PO"
11141741|NCT01824693|FG002|Participant Flow|ARM III (Non-Randomized)|Patients who were not randomized and did not proceed to transplant because they did not meet all the protocol requirement for randomization
11141742|NCT01824693|OG000|Outcome|Arm I (Busulfan, Cyclophosphamide, Melphalan)|"CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1.~TRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy.~Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT~Busulfan: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given IV or PO~Pharmacological Study: Correlative studies~Tacrolimus: Given IV or PO"
11141743|NCT01824693|OG001|Outcome|Arm II (Busulfan, Fludarabine Phosphate)|"CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2.~TRANSPLANT: Patients undergo allogeneic HCT as in Arm I.~Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT~Busulfan: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Pharmacological Study: Correlative studies~Tacrolimus: Given IV or PO"
11141744|NCT01824693|EG000|Reported Event|Arm I (Busulfan, Cyclophosphamide, Melphalan)|"CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1.~TRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy.~Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT~Busulfan: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given IV or PO~Pharmacological Study: Correlative studies~Tacrolimus: Given IV or PO"
11141745|NCT01824693|EG001|Reported Event|Arm II (Busulfan, Fludarabine Phosphate)|"CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2.~TRANSPLANT: Patients undergo allogeneic HCT as in Arm I.~Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT~Busulfan: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Pharmacological Study: Correlative studies~Tacrolimus: Given IV or PO"
11141746|NCT01824693|EG002|Reported Event|ARM III (Non-Randomized)|Patients who have not met all protocol requirements to proceed to HCT
11141747|NCT01824823|BG000|Baseline|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
11141748|NCT01824823|BG001|Baseline|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
11141749|NCT01824823|BG002|Baseline|Total|Total of all reporting groups
11141750|NCT01824823|FG000|Participant Flow|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
11141751|NCT01824823|FG001|Participant Flow|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
11141752|NCT01824823|OG000|Outcome|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
11141753|NCT01824823|OG001|Outcome|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
11141754|NCT01824823|EG000|Reported Event|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
11141755|NCT01824823|EG001|Reported Event|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
11141756|NCT01824901|BG000|Baseline|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11141757|NCT01824901|FG000|Participant Flow|Phase I|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~AZD4547: Given PO"
11141758|NCT01824901|FG001|Participant Flow|Arm I (Docetaxel; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience progressive disease may then register to step II treatment and receive FGFR inhibitor AZD4547 PO BID on days 1-14.~docetaxel: Given IV"
11141759|NCT01824901|FG002|Participant Flow|Arm II (Docetaxel and AZD4547; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~AZD4547: Given PO"
11141760|NCT01824901|FG003|Participant Flow|Phase II Step II|"Patients receive FGFR inhibitor AZD4547 PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~AZD4547: Given PO"
11141761|NCT01824901|OG000|Outcome|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11141762|NCT01824901|EG000|Reported Event|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11141763|NCT01824979|BG000|Baseline|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
11141764|NCT01824979|BG001|Baseline|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
11141765|NCT01824979|BG002|Baseline|Total|Total of all reporting groups
11141766|NCT01824979|FG000|Participant Flow|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
11141767|NCT01824979|FG001|Participant Flow|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
11141768|NCT01824979|OG000|Outcome|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
11141769|NCT01824979|OG001|Outcome|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
11141770|NCT01824979|EG000|Reported Event|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
11141771|NCT01824979|EG001|Reported Event|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
11141772|NCT01825057|BG000|Baseline|See One|"Providers in See One only receive MI workshop training, giving them an opportunity to see the MI intervention and learn how to conduct it. The trainer encourages them to screen their patients for substance misuse and apply MI as indicated."
11141773|NCT01825057|BG001|Baseline|Do One|Following workshop training, MI-trained CL clinicians directly supervise providers' live bedside provision of MI to patients twice before beginning the trial and once midstream. In addition, providers have the option to request additional live supervision from CL clinicians during the trial, consistent with the apprenticeship model.
11141774|NCT01825057|BG002|Baseline|Order One|"Following the workshop, providers either administer MI themselves or order a MI for delivery by one of the MI-trained CL clinicians. Only providers in Order One can specifically request MI through a separate CL order in the electronic health record. The physicians or PAs directly place MI orders. Nurses contact physicians or PAs to place the MI order. The CL clinicians are trained in MI via a clinical trials training approach: 1) a 2-day skill-building workshop; 2) three post-workshop supervised practice cases based on review of audio recorded sessions; and 3) follow-up monthly group supervision to maintain and monitor the CL clinicians' MI practice. CL clinicians also learned supervisory practices to provide live supervision to providers in Do One."
11141775|NCT01825057|BG003|Baseline|Total|Total of all reporting groups
11141776|NCT01825057|FG000|Participant Flow|See One|"Providers in See One only receive MI workshop training, giving them an opportunity to see the MI intervention and learn how to conduct it. The trainer encourages them to screen their patients for substance misuse and apply MI as indicated."
11141777|NCT01825057|FG001|Participant Flow|Do One|Following workshop training, MI-trained CL clinicians directly supervise providers' live bedside provision of MI to patients twice before beginning the trial and once midstream. In addition, providers have the option to request additional live supervision from CL clinicians during the trial, consistent with the apprenticeship model.
11141778|NCT01825057|FG002|Participant Flow|Order One|"Following the workshop, providers either administer MI themselves or order a MI for delivery by one of the MI-trained CL clinicians. Only providers in Order One can specifically request MI through a separate CL order in the electronic health record. The physicians or PAs directly place MI orders. Nurses contact physicians or PAs to place the MI order. The CL clinicians are trained in MI via a clinical trials training approach: 1) a 2-day skill-building workshop; 2) three post-workshop supervised practice cases based on review of audio recorded sessions; and 3) follow-up monthly group supervision to maintain and monitor the CL clinicians' MI practice. CL clinicians also learned supervisory practices to provide live supervision to providers in Do One."
11141779|NCT01825057|OG000|Outcome|See One|"Providers in See One only receive MI workshop training, giving them an opportunity to see the MI intervention and learn how to conduct it. The trainer encourages them to screen their patients for substance misuse and apply MI as indicated."
11141780|NCT01825057|OG001|Outcome|Do One|Following workshop training, MI-trained CL clinicians directly supervise providers' live bedside provision of MI to patients twice before beginning the trial and once midstream. In addition, providers have the option to request additional live supervision from CL clinicians during the trial, consistent with the apprenticeship model.
11141781|NCT01825057|OG002|Outcome|Order One|"Following the workshop, providers either administer MI themselves or order a MI for delivery by one of the MI-trained CL clinicians. Only providers in Order One can specifically request MI through a separate CL order in the electronic health record. The physicians or PAs directly place MI orders. Nurses contact physicians or PAs to place the MI order. The CL clinicians are trained in MI via a clinical trials training approach: 1) a 2-day skill-building workshop; 2) three post-workshop supervised practice cases based on review of audio recorded sessions; and 3) follow-up monthly group supervision to maintain and monitor the CL clinicians' MI practice. CL clinicians also learned supervisory practices to provide live supervision to providers in Do One."
11141782|NCT01825057|OG000|Outcome|See One|"Providers in See One only received the workshop training, giving them an opportunity to see the MI intervention and learn how to conduct it. The trainer encouraged them to screen their patients for substance misuse and apply MI as indicated."
11141783|NCT01825057|OG001|Outcome|Do One|Following workshop training, the MI-trained consultation-liaison clinicians directly supervised providers' live bedside provision of MI to patients twice before beginning the trial and once mid-trial. In addition, providers had the option to request additional live supervision from consultation-liaison clinicians during the trial, consistent with the apprenticeship model.
11141784|NCT01825057|OG002|Outcome|Order One|"Following the workshop training, providers had the option to either administer MI themselves or order a MI for delivery by one of the four MI-trained consultation-liaison clinicians."
11141785|NCT01825057|EG000|Reported Event|See One|"Providers in See One only receive MI workshop training, giving them an opportunity to see the MI intervention and learn how to conduct it. The trainer encourages them to screen their patients for substance misuse and apply MI as indicated."
11141786|NCT01825057|EG001|Reported Event|Do One|Following workshop training, MI-trained CL clinicians directly supervise providers' live bedside provision of MI to patients twice before beginning the trial and once midstream. In addition, providers have the option to request additional live supervision from CL clinicians during the trial, consistent with the apprenticeship model.
11141787|NCT01825057|EG002|Reported Event|Order One|"Following the workshop, providers either administer MI themselves or order a MI for delivery by one of the MI-trained CL clinicians. Only providers in Order One can specifically request MI through a separate CL order in the electronic health record. The physicians or PAs directly place MI orders. Nurses contact physicians or PAs to place the MI order. The CL clinicians are trained in MI via a clinical trials training approach: 1) a 2-day skill-building workshop; 2) three post-workshop supervised practice cases based on review of audio recorded sessions; and 3) follow-up monthly group supervision to maintain and monitor the CL clinicians' MI practice. CL clinicians also learned supervisory practices to provide live supervision to providers in Do One."
11141788|NCT01825122|BG000|Baseline|Placebo|"placebo~Placebo"
11141789|NCT01825122|BG001|Baseline|Active, Nadolol|"Active~Nadolol"
11141790|NCT01825122|BG002|Baseline|Total|Total of all reporting groups
11141791|NCT01825122|FG000|Participant Flow|Placebo|"placebo~Placebo"
11141792|NCT01825122|FG001|Participant Flow|Active, Nadolol|"Active~Nadolol"
11141793|NCT01825122|OG000|Outcome|Placebo|"placebo~Placebo"
11141794|NCT01825122|OG001|Outcome|Active, Nadolol|"Active~Nadolol"
11141795|NCT01825122|EG000|Reported Event|Placebo|"placebo~Placebo"
11141796|NCT01825122|EG001|Reported Event|Active, Nadolol|"Active~Nadolol"
11141797|NCT01825200|BG000|Baseline|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
11141798|NCT01825200|BG001|Baseline|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
11141799|NCT01825200|BG002|Baseline|Total|Total of all reporting groups
11141800|NCT01825200|FG000|Participant Flow|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
11141801|NCT01825200|FG001|Participant Flow|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
11141802|NCT01825200|OG000|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
11141803|NCT01825200|OG001|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
11141804|NCT01825200|EG000|Reported Event|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
11141805|NCT01825200|EG001|Reported Event|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
11141806|NCT01825408|BG000|Baseline|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141807|NCT01825408|BG001|Baseline|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141808|NCT01825408|BG002|Baseline|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141809|NCT01825408|BG003|Baseline|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141810|NCT01825408|BG004|Baseline|Total|Total of all reporting groups
11141811|NCT01825408|FG000|Participant Flow|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141812|NCT01825408|FG001|Participant Flow|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141813|NCT01825408|FG002|Participant Flow|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141814|NCT01825408|FG003|Participant Flow|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141815|NCT01825408|OG000|Outcome|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141816|NCT01825408|OG001|Outcome|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141817|NCT01825408|OG000|Outcome|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141818|NCT01825408|OG001|Outcome|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141819|NCT01825408|EG000|Reported Event|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141820|NCT01825408|EG001|Reported Event|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141821|NCT01825408|EG002|Reported Event|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141822|NCT01825408|EG003|Reported Event|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
11141823|NCT01825512|BG000|Baseline|Deferiprone|"75-100 mg/kg/day seven days per week~Deferiprone: Deferiprone 80 mg/mL oral solution"
11141824|NCT01825512|BG001|Baseline|Deferasirox|"20 to 40 mg/kg/day seven days per week~Deferasirox: Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg"
11141825|NCT01825512|BG002|Baseline|Total|Total of all reporting groups
11141826|NCT01825512|FG000|Participant Flow|Deferiprone|"75-100 mg/kg/day seven days per week~Deferiprone: Deferiprone 80 mg/mL oral solution"
11141827|NCT01825512|FG001|Participant Flow|Deferasirox|"20 to 40 mg/kg/day seven days per week~Deferasirox: Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg"
11141828|NCT01825512|OG000|Outcome|Deferiprone|"75-100 mg/kg/day seven days per week~Deferiprone: Deferiprone 80 mg/mL oral solution"
11141829|NCT01825512|OG001|Outcome|Deferasirox|"20 to 40 mg/kg/day seven days per week~Deferasirox: Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg"
11141830|NCT01825512|EG000|Reported Event|Deferiprone|"75-100 mg/kg/day seven days per week~Deferiprone: Deferiprone 80 mg/mL oral solution"
11141831|NCT01825512|EG001|Reported Event|Deferasirox|"20 to 40 mg/kg/day seven days per week~Deferasirox: Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg"
11141832|NCT01825577|BG000|Baseline|Single Arm|"Age 65yrs and above~Ability to ambulate (may use walking aid)~Male or Female~Clinical diagnosis of probable Alzheimer's Disease~AES score >40~Identified as fall risk by nursing staff"
11141833|NCT01825577|FG000|Participant Flow|Single Arm Transdermal Methylphenidate|"Age 65 yrs and above~Ability to ambulate (may use walking aid)~Male or Female~Clinical diagnosis of probable Alzheimer's Disease~AES score >40~Identified as fall risk by nursing staff"
11141834|NCT01825577|OG000|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.~Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
11141835|NCT01825577|EG000|Reported Event|Single Arm Transdermal Methylphenidate|There were no adverse events reported.
11141836|NCT01825655|BG000|Baseline|Cetirizine|"zyrtec 10mg, oral, one time~Cetirizine"
11141837|NCT01825655|BG001|Baseline|Sugar Pill|"Placebo, one pill, one time~Placebo or sugar pill"
11141838|NCT01825655|BG002|Baseline|Total|Total of all reporting groups
11141839|NCT01825655|FG000|Participant Flow|Cetirizine|"zyrtec 10mg, oral, one time~Cetirizine"
11141840|NCT01825655|FG001|Participant Flow|Sugar Pill|"Placebo, one pill, one time~Placebo or sugar pill"
11141841|NCT01825655|OG000|Outcome|Cetirizine|"zyrtec 10mg, oral, one time~Cetirizine"
11141842|NCT01825655|OG001|Outcome|Sugar Pill|"Placebo, one pill, one time~Placebo or sugar pill"
11141843|NCT01825655|EG000|Reported Event|Cetirizine|"zyrtec 10mg, oral, one time~Cetirizine"
11141844|NCT01825655|EG001|Reported Event|Sugar Pill|"Placebo, one pill, one time~Placebo or sugar pill"
11141845|NCT01825785|BG000|Baseline|Placebo|Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
11141846|NCT01825785|BG001|Baseline|Romosozumab 1 mg/kg Q2W in Women|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141847|NCT01825785|BG002|Baseline|Romosozumab 2 mg/kg Q4W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141848|NCT01825785|BG003|Baseline|Romosozumab 2 mg/kg Q2W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141849|NCT01825785|BG004|Baseline|Romosozumab 3 mg/kg Q4W in Women|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141850|NCT01825785|BG005|Baseline|Romosozumab 1 mg/kg Q2W in Men|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141851|NCT01825785|BG006|Baseline|Romosozumab 3 mg/kg Q4W in Men|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141852|NCT01825785|BG007|Baseline|Total|Total of all reporting groups
11141853|NCT01825785|FG000|Participant Flow|Placebo|Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
11141854|NCT01825785|FG001|Participant Flow|Romosozumab 1 mg/kg Q2W in Women|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141855|NCT01825785|FG002|Participant Flow|Romosozumab 2 mg/kg Q4W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141856|NCT01825785|FG003|Participant Flow|Romosozumab 2 mg/kg Q2W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141857|NCT01825785|FG004|Participant Flow|Romosozumab 3 mg/kg Q4W in Women|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141858|NCT01825785|FG005|Participant Flow|Romosozumab 1 mg/kg Q2W in Men|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141859|NCT01825785|FG006|Participant Flow|Romosozumab 3 mg/kg Q4W in Men|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141860|NCT01825785|OG000|Outcome|Placebo|Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
11141861|NCT01825785|OG001|Outcome|Romosozumab 1 mg/kg Q2W in Women|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141862|NCT01825785|OG002|Outcome|Romosozumab 2 mg/kg Q4W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141863|NCT01825785|OG003|Outcome|Romosozumab 2 mg/kg Q2W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141864|NCT01825785|OG004|Outcome|Romosozumab 3 mg/kg Q4W in Women|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141865|NCT01825785|OG005|Outcome|Romosozumab 1 mg/kg Q2W in Men|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141866|NCT01825785|OG006|Outcome|Romosozumab 3 mg/kg Q4W in Men|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
10887436|NCT00500357|OG001|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
11141867|NCT01825785|OG000|Outcome|Romosozumab 1 mg/kg Q2W in Women|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141868|NCT01825785|OG001|Outcome|Romosozumab 2 mg/kg Q4W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141869|NCT01825785|OG002|Outcome|Romosozumab 2 mg/kg Q2W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141870|NCT01825785|OG003|Outcome|Romosozumab 3 mg/kg Q4W in Women|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141871|NCT01825785|OG004|Outcome|Romosozumab 1 mg/kg Q2W in Men|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141872|NCT01825785|OG005|Outcome|Romosozumab 3 mg/kg Q4W in Men|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141873|NCT01825785|EG000|Reported Event|Placebo|Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
11141874|NCT01825785|EG001|Reported Event|Romosozumab 1 mg/kg Q2W in Women|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141875|NCT01825785|EG002|Reported Event|Romosozumab 2 mg/kg Q4W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141876|NCT01825785|EG003|Reported Event|Romosozumab 2 mg/kg Q2W in Women|Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141877|NCT01825785|EG004|Reported Event|Romosozumab 3 mg/kg Q4W in Women|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141878|NCT01825785|EG005|Reported Event|Romosozumab 1 mg/kg Q2W in Men|Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
11141879|NCT01825785|EG006|Reported Event|Romosozumab 3 mg/kg Q4W in Men|Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
11141880|NCT01825798|BG000|Baseline|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
11149773|NCT01873495|FG000|Participant Flow|Omacetaxine: Consolidation/Maintenance|"Omacetaxine: Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.~Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles"
11141881|NCT01825798|BG001|Baseline|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
11141882|NCT01825798|BG002|Baseline|Total|Total of all reporting groups
11141883|NCT01825798|FG000|Participant Flow|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
11141884|NCT01825798|FG001|Participant Flow|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
11141885|NCT01825798|OG000|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
11141886|NCT01825798|OG001|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
11141887|NCT01825798|EG000|Reported Event|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
11141888|NCT01825798|EG001|Reported Event|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
11141889|NCT01825837|BG000|Baseline|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141890|NCT01825837|BG001|Baseline|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141891|NCT01825837|BG002|Baseline|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141892|NCT01825837|BG003|Baseline|ESL (Part I - Not Randomised Patients)|This group corresponds to the 17 patients who did not complete part I and therefore where not randomised to any traeatment group.
11141893|NCT01825837|BG004|Baseline|Total|Total of all reporting groups
11141894|NCT01825837|FG000|Participant Flow|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141895|NCT01825837|FG001|Participant Flow|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141896|NCT01825837|FG002|Participant Flow|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141897|NCT01825837|FG003|Participant Flow|ESL (Part I)|In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. The participants that completed part I were randomised in Part II.
11141898|NCT01825837|OG000|Outcome|BIA 2-093 300 mg|PART II - Intent-to-Treat Population
11141899|NCT01825837|OG001|Outcome|BIA 2-093 900 mg|PART II - Intent-to-Treat Population
11141900|NCT01825837|OG002|Outcome|BIA 2-093 1800 mg|PART II - Intent-to-Treat Population
11141901|NCT01825837|EG000|Reported Event|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141902|NCT01825837|EG001|Reported Event|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141903|NCT01825837|EG002|Reported Event|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
11141904|NCT01825876|BG000|Baseline|Overall Study|Participants were administered 15 mg warfarin as a single oral dose on Days 1 and 17; 130 mg evacetrapib was administered QD, orally, on Days 7 to 22.
11141905|NCT01825876|FG000|Participant Flow|15 mg Warfarin|15 milligram (mg) warfarin administered as a single oral dose on Day 1
11141906|NCT01825876|FG001|Participant Flow|130 mg Evacetrapib + 15 mg Warfarin|130 mg evacetrapib alone administered once daily (QD), orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
11141907|NCT01825876|OG000|Outcome|Warfarin|15 mg warfarin administered as a single oral dose
11141908|NCT01825876|OG001|Outcome|Evacetrapib + Warfarin|130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
11141909|NCT01825876|OG000|Outcome|15 mg Warfarin|15 mg warfarin administered as a single oral dose on Day 1
11141910|NCT01825876|OG001|Outcome|130 mg Evacetrapib + 15 mg Warfarin|130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
11141911|NCT01825876|EG000|Reported Event|15 mg Warfarin|15 mg warfarin administered as a single oral dose on Day 1
11141912|NCT01825876|EG001|Reported Event|130 mg Evacetrapib|130 mg evacetrapib alone administered QD, orally, on Days 7 to 22
11141913|NCT01825876|EG002|Reported Event|130 mg Evacetrapib + 15 mg Warfarin|130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
11141914|NCT01825889|BG000|Baseline|Evacetrapib (Participants With Renal Impairment)|Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
11141915|NCT01825889|BG001|Baseline|Evacetrapib (Healthy Participants)|Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
11141916|NCT01825889|BG002|Baseline|Total|Total of all reporting groups
11141917|NCT01825889|FG000|Participant Flow|Evacetrapib (Participants With Renal Impairment)|Single oral dose of 130 milligrams (mg) evacetrapib on Day 1 to participants with severe renal impairment.
11141918|NCT01825889|FG001|Participant Flow|Evacetrapib (Healthy Participants)|Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
11141919|NCT01825889|OG000|Outcome|Evacetrapib (Participants With Renal Impairment)|Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
11141920|NCT01825889|OG001|Outcome|Evacetrapib (Healthy Participants)|Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
11141921|NCT01825889|EG000|Reported Event|Evacetrapib (Participants With Renal Impairment)|Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
11141922|NCT01825889|EG001|Reported Event|Evacetrapib (Healthy Participants)|Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
11141923|NCT01825941|BG000|Baseline|Metoclopramide + Diphenhydramine|"Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~diphenhydramine: 50 milligrams, administered intravenously over 15 minutes"
11141924|NCT01825941|BG001|Baseline|Metoclopramide + Placebo|"Metoclopramide 10mg + placebo, administered intravenously over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~placebo"
11141925|NCT01825941|BG002|Baseline|Total|Total of all reporting groups
11141926|NCT01825941|FG000|Participant Flow|Metoclopramide + Diphenhydramine|"Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~diphenhydramine: 50 milligrams, administered intravenously over 15 minutes"
11141927|NCT01825941|FG001|Participant Flow|Metoclopramide + Placebo|"Metoclopramide 10mg + placebo, administered intravenously over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~placebo"
11141928|NCT01825941|OG000|Outcome|Metoclopramide + Diphenhydramine|"Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~diphenhydramine: 50 milligrams, administered intravenously over 15 minutes"
11141929|NCT01825941|OG001|Outcome|Metoclopramide + Placebo|"Metoclopramide 10mg + placebo, administered intravenously over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~placebo"
11141930|NCT01825941|EG000|Reported Event|Metoclopramide + Diphenhydramine|"Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~diphenhydramine: 50 milligrams, administered intravenously over 15 minutes"
11141931|NCT01825941|EG001|Reported Event|Metoclopramide + Placebo|"Metoclopramide 10mg + placebo, administered intravenously over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~placebo"
11141932|NCT01826201|BG000|Baseline|10% MOL4239 Ointment & Placebo Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
11141933|NCT01826201|FG000|Participant Flow|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
11141934|NCT01826201|OG000|Outcome|10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
11141935|NCT01826201|OG001|Outcome|Placebo Ointment|10% MOL4239 to one target lesion and placebo to contralateral target lesion
11141936|NCT01826201|OG000|Outcome|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
11141937|NCT01826201|EG000|Reported Event|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
11141938|NCT01826214|BG000|Baseline|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
11141939|NCT01826214|BG001|Baseline|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
11141940|NCT01826214|BG002|Baseline|Total|Total of all reporting groups
11141941|NCT01826214|FG000|Participant Flow|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
11141942|NCT01826214|FG001|Participant Flow|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
11141943|NCT01826214|OG000|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
11141944|NCT01826214|OG001|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
11141945|NCT01826214|EG000|Reported Event|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
11141946|NCT01826214|EG001|Reported Event|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
11141947|NCT01826227|BG000|Baseline|Positron Emission Tomography|"This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.~Positron Emission Tomography~18F-Fluoro-2-deoxy-D-lucose~Cytoreductive surgery"
11141948|NCT01826227|FG000|Participant Flow|Positron Emission Tomography|"This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.~Positron Emission Tomography~18F-Fluoro-2-deoxy-D-lucose~Cytoreductive surgery"
11141949|NCT01826227|OG000|Outcome|Positron Emission Tomography|"This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.~Positron Emission Tomography~18F-Fluoro-2-deoxy-D-lucose~Cytoreductive surgery"
11149774|NCT01873495|OG000|Outcome|Omacetaxine: Consolidation/Maintenance|"Omacetaxine: Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.~Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles"
11141950|NCT01826227|EG000|Reported Event|Positron Emission Tomography|"This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.~Positron Emission Tomography~18F-Fluoro-2-deoxy-D-lucose~Cytoreductive surgery"
11141951|NCT01826370|BG000|Baseline|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
11141952|NCT01826370|FG000|Participant Flow|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
11141953|NCT01826370|OG000|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
11141954|NCT01826370|EG000|Reported Event|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
11141955|NCT01826422|BG000|Baseline|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
11141956|NCT01826422|BG001|Baseline|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
11141957|NCT01826422|BG002|Baseline|Total|Total of all reporting groups
11141958|NCT01826422|FG000|Participant Flow|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
11141959|NCT01826422|FG001|Participant Flow|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
11141960|NCT01826422|OG000|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
11141961|NCT01826422|OG001|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
11141962|NCT01826422|EG000|Reported Event|EPA and DHA|"Supplementation of 2.9 g / d of EPA and DHA will be provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade.~EPA and DHA: Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U."
11141963|NCT01826422|EG001|Reported Event|Sunflower Oil|"Supplementation of placebo with sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process. This placebo is sunflower oil and so will not expected to produce anti-inflammatory or insulin sensitivity effects.~Placebo Comparator: Sunflower oil; the placebo capsules will also contain sunflower oil. Each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg."
11141964|NCT01826448|BG000|Baseline|Cohort 1; PLX3397 800 mg/Day + Vemurafenib 720 mg BID|Participant who received 800 mg/day (400 twice daily [BID]) of PLX3397 and 720 mg BID of vemurafenib.
11141965|NCT01826448|BG001|Baseline|Cohort 2; PLX3397 800 mg/Day + Vemurafenib 960 mg BID|Participants who received 800 mg/day (400 twice daily [BID]) of PLX3397 and 960 mg BID of vemurafenib.
11141966|NCT01826448|BG002|Baseline|Total|Total of all reporting groups
11141967|NCT01826448|FG000|Participant Flow|Cohort 1; PLX3397 800 mg/Day + Vemurafenib 720 mg BID|Participant who received 800 mg/day (400 twice daily [BID]) of PLX3397 and 720 mg BID of vemurafenib.
11141968|NCT01826448|FG001|Participant Flow|Cohort 2; PLX3397 800 mg/Day + Vemurafenib 960 mg BID|Participants who received 800 mg/day (400 twice daily [BID]) of PLX3397 and 960 mg BID of vemurafenib.
11141969|NCT01826448|OG000|Outcome|Cohort 1; PLX3397 800 mg/Day + Vemurafenib 720 mg BID|Participant who received 800 mg/day (400 twice daily [BID]) of PLX3397 and 720 mg BID of vemurafenib.
11141970|NCT01826448|OG001|Outcome|Cohort 2; PLX3397 800 mg/Day + Vemurafenib 960 mg BID|Participants who received 800 mg/day (400 twice daily [BID]) of PLX3397 and 960 mg BID of vemurafenib.
11141971|NCT01826448|EG000|Reported Event|Cohort 1; PLX3397 800 mg/Day + Vemurafenib 720 mg BID|Participant who received 800 mg/day (400 twice daily [BID] of PLX3397 and 720 mg BID of vemurafenib.
11141972|NCT01826448|EG001|Reported Event|Cohort 2; PLX3397 800 mg/Day + Vemurafenib 960 mg BID|Participants who received 800 mg/day (400 twice daily [BID]) of PLX3397 and 960 mg BID of vemurafenib.
11141973|NCT01826487|BG000|Baseline|Placebo|Participants received placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
11141974|NCT01826487|BG001|Baseline|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
11141975|NCT01826487|BG002|Baseline|Total|Total of all reporting groups
11141976|NCT01826487|FG000|Participant Flow|Placebo|Participants received placebo matched to ataluren orally 3 times a day (TID) at morning, midday, and evening for 48 weeks.
11141977|NCT01826487|FG001|Participant Flow|Ataluren|Participants received ataluren suspension orally TID, 10 milligrams/kilogram (mg/kg) at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
11141978|NCT01826487|OG000|Outcome|Placebo|Participants received placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
11141979|NCT01826487|OG001|Outcome|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
11141980|NCT01826487|OG000|Outcome|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
11141981|NCT01826487|EG000|Reported Event|Placebo|Participants received placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
11141982|NCT01826487|EG001|Reported Event|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
11141983|NCT01826513|BG000|Baseline|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
11141984|NCT01826513|BG001|Baseline|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
11141985|NCT01826513|BG002|Baseline|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night
11141986|NCT01826513|BG003|Baseline|Total|Total of all reporting groups
11141987|NCT01826513|FG000|Participant Flow|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
11141988|NCT01826513|FG001|Participant Flow|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
11141989|NCT01826513|FG002|Participant Flow|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
11141990|NCT01826513|OG000|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
11141991|NCT01826513|OG001|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
11141992|NCT01826513|EG000|Reported Event|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
11141993|NCT01826513|EG001|Reported Event|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
11141994|NCT01826513|EG002|Reported Event|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
11141995|NCT01826604|BG000|Baseline|Alexis O C-section Retractor|Alexis O retractor used during C-section
11141996|NCT01826604|BG001|Baseline|Control|Other retractor used during C-section
11141997|NCT01826604|BG002|Baseline|Total|Total of all reporting groups
11141998|NCT01826604|FG000|Participant Flow|Alexis O C-section Retractor|"The Alexis O C-section retractor will be used. Other hand-held retractors will be used as deemed necessary by the surgeon.~Alexis O C-Section Retractor: The Alexis O C-section retractor will be used. Other hand-held retractors that are deemed necessary to the surgery by the physician will also be used."
11141999|NCT01826604|FG001|Participant Flow|Control|"Conventional hand-held surgical retractors used for C-sections will be used, including the bladder blade (Doyen retractor) and the Richardson retractor.~Control- Conventional hand-held retractors: Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used."
11142000|NCT01826604|OG000|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
11142001|NCT01826604|OG001|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
11142002|NCT01826604|EG000|Reported Event|Alexis Retractor|No adverse events
11142003|NCT01826604|EG001|Reported Event|Control|No adverse events
11142004|NCT01826812|BG000|Baseline|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
11142005|NCT01826812|BG001|Baseline|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
11142006|NCT01826812|BG002|Baseline|Total|Total of all reporting groups
11142007|NCT01826812|FG000|Participant Flow|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
11142008|NCT01826812|FG001|Participant Flow|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
11142009|NCT01826812|OG000|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
11142010|NCT01826812|OG001|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
11142011|NCT01826812|OG000|Outcome|Dry Eye|Patients with Sjogren Syndrome related or non-Sjogren Syndrome related dry eye.
11142012|NCT01826812|OG001|Outcome|Controls|Participants without dry eye.
11142013|NCT01826812|EG000|Reported Event|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
11142014|NCT01826812|EG001|Reported Event|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
11142015|NCT01826825|BG000|Baseline|Clock in the Box|"Results of the Clock in the box cognitive screening test.~Cognitive Screen: Cognitive Screen"
11142016|NCT01826825|BG001|Baseline|Mini-Cog|"Results of the mini-cog cognitive screen~Mini-Cog: Cognitive Screen"
11142017|NCT01826825|BG002|Baseline|Total|Total of all reporting groups
11142018|NCT01826825|FG000|Participant Flow|Clock in the Box|"Results of the Clock in the box cognitive screening test.~Cognitive Screen: Cognitive Screen"
11142019|NCT01826825|FG001|Participant Flow|Mini-Cog|"Results of the mini-cog cognitive screen~Mini-Cog: Cognitive Screen"
11142020|NCT01826825|OG000|Outcome|Clock in the Box|"Results of the Clock in the box cognitive screening test.~Cognitive Screen: Cognitive Screen"
11142021|NCT01826825|OG001|Outcome|Mini-Cog|"Results of the mini-cog cognitive screen~Mini-Cog: Cognitive Screen"
11142022|NCT01826825|OG000|Outcome|MiniCog|Duration of the preoperative evaluation for patients randomized to the MiniCog cognitive screen.
11142023|NCT01826825|OG001|Outcome|Clock in the Box|Duration of the preoperative evaluation for patients randomized to the Clock in the Box cognitive screen.
11142024|NCT01826825|EG000|Reported Event|Clock in the Box|"Results of the Clock in the box cognitive screening test.~Cognitive Screen: Cognitive Screen"
11142025|NCT01826825|EG001|Reported Event|Mini-Cog|"Results of the mini-cog cognitive screen~Mini-Cog: Cognitive Screen"
11142026|NCT01826851|BG000|Baseline|Exparel|"266 mg Exparel, single-dose injection.~Exparel: Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.~Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU."
11142027|NCT01826851|BG001|Baseline|Placebo|"0.9% Normal saline, single-dose injection.~Placebo: Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.~Post-surgical pain management will be the same as for the Exparel group."
11142028|NCT01826851|BG002|Baseline|Total|Total of all reporting groups
11142029|NCT01826851|FG000|Participant Flow|Exparel|"266 mg Exparel, single-dose injection.~Exparel: Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.~Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU."
11142030|NCT01826851|FG001|Participant Flow|Placebo|"0.9% Normal saline, single-dose injection.~Placebo: Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.~Post-surgical pain management will be the same as for the Exparel group."
11142031|NCT01826851|OG000|Outcome|Exparel|"266 mg Exparel, single-dose injection.~Exparel: Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.~Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU."
11142032|NCT01826851|OG001|Outcome|Placebo|"0.9% Normal saline, single-dose injection.~Placebo: Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.~Post-surgical pain management will be the same as for the Exparel group."
11142033|NCT01826851|EG000|Reported Event|Exparel|"266 mg Exparel, single-dose injection.~Exparel: Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.~Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU."
11142034|NCT01826851|EG001|Reported Event|Placebo|"0.9% Normal saline, single-dose injection.~Placebo: Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.~Post-surgical pain management will be the same as for the Exparel group."
11142035|NCT01826981|BG000|Baseline|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
11142036|NCT01826981|BG001|Baseline|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142037|NCT01826981|BG002|Baseline|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
11142038|NCT01826981|BG003|Baseline|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
11142039|NCT01826981|BG004|Baseline|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
11142040|NCT01826981|BG005|Baseline|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
11142041|NCT01826981|BG006|Baseline|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
11142042|NCT01826981|BG007|Baseline|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
11142043|NCT01826981|BG008|Baseline|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
11142044|NCT01826981|BG009|Baseline|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142045|NCT01826981|BG010|Baseline|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142046|NCT01826981|BG011|Baseline|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142047|NCT01826981|BG012|Baseline|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142048|NCT01826981|BG013|Baseline|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142049|NCT01826981|BG014|Baseline|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
11142050|NCT01826981|BG015|Baseline|Total|Total of all reporting groups
11142051|NCT01826981|FG000|Participant Flow|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
11142052|NCT01826981|FG001|Participant Flow|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142053|NCT01826981|FG002|Participant Flow|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
11142054|NCT01826981|FG003|Participant Flow|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
11142055|NCT01826981|FG004|Participant Flow|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
11142056|NCT01826981|FG005|Participant Flow|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
11142057|NCT01826981|FG006|Participant Flow|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
11142058|NCT01826981|FG007|Participant Flow|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
11142059|NCT01826981|FG008|Participant Flow|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis
11142060|NCT01826981|FG009|Participant Flow|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142061|NCT01826981|FG010|Participant Flow|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142062|NCT01826981|FG011|Participant Flow|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142063|NCT01826981|FG012|Participant Flow|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142064|NCT01826981|FG013|Participant Flow|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142065|NCT01826981|FG014|Participant Flow|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
11142066|NCT01826981|OG000|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
11142067|NCT01826981|OG001|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142068|NCT01826981|OG002|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
11142069|NCT01826981|OG003|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
11142070|NCT01826981|OG004|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
11142071|NCT01826981|OG005|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
11142072|NCT01826981|OG006|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
11142073|NCT01826981|OG007|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
11142074|NCT01826981|OG008|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
11142075|NCT01826981|OG009|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142076|NCT01826981|OG010|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142077|NCT01826981|OG011|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142078|NCT01826981|OG012|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142079|NCT01826981|OG013|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142080|NCT01826981|OG014|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
11142081|NCT01826981|OG009|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142082|NCT01826981|OG010|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
11142083|NCT01826981|OG000|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142084|NCT01826981|OG000|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
11142085|NCT01826981|EG000|Reported Event|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
11142086|NCT01826981|EG001|Reported Event|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142087|NCT01826981|EG002|Reported Event|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
11142088|NCT01826981|EG003|Reported Event|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
11142089|NCT01826981|EG004|Reported Event|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
11142090|NCT01826981|EG005|Reported Event|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
11142091|NCT01826981|EG006|Reported Event|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
11142092|NCT01826981|EG007|Reported Event|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
11142093|NCT01826981|EG008|Reported Event|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
11142094|NCT01826981|EG009|Reported Event|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
11142095|NCT01826981|EG010|Reported Event|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
11142096|NCT01826981|EG011|Reported Event|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142097|NCT01826981|EG012|Reported Event|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142098|NCT01826981|EG013|Reported Event|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142099|NCT01826981|EG014|Reported Event|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
11142100|NCT01827046|BG000|Baseline|MIS Plus Rt-PA Management|"Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.~rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery."
11142101|NCT01827046|BG001|Baseline|Medical Management|Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
11142102|NCT01827046|BG002|Baseline|Total|Total of all reporting groups
11142103|NCT01827046|FG000|Participant Flow|MIS Plus Rt-PA Management|"Subjects randomized to the Minimally Invasive Surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.~rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery."
11142104|NCT01827046|FG001|Participant Flow|Medical Management|Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
11142105|NCT01827046|OG000|Outcome|MIS Plus Rt-PA Management|"Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.~rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery."
11142106|NCT01827046|OG001|Outcome|Medical Management|Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
11142107|NCT01827046|EG000|Reported Event|MIS Plus Rt-PA Management|"Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.~rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery."
11142108|NCT01827046|EG001|Reported Event|Medical Management|Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
11142109|NCT01827163|BG000|Baseline|Paclitaxel With Trastuzumab and Lapatinib|"Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.~Paclitaxel"
11142110|NCT01827163|FG000|Participant Flow|Paclitaxel With Trastuzumab and Lapatinib|"Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.~Paclitaxel"
11149775|NCT01873495|EG000|Reported Event|Omacetaxine: Consolidation/Maintenance|"Omacetaxine: Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.~Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles"
11142111|NCT01827163|OG000|Outcome|Paclitaxel With Trastuzumab and Lapatinib|"Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.~Paclitaxel"
11142112|NCT01827163|EG000|Reported Event|Paclitaxel With Trastuzumab and Lapatinib|"Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.~Paclitaxel"
11149776|NCT01873586|BG000|Baseline|All Study Participants|Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
11149777|NCT01873586|FG000|Participant Flow|All Patients|Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
11149778|NCT01873586|OG000|Outcome|All Patients|Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
11149779|NCT01873586|OG000|Outcome|All Patients|
11149780|NCT01873586|OG000|Outcome|All Patients|All Patients
11149781|NCT01873586|OG000|Outcome|All Patients|Posterolateral fusion study in which one spinal level is treated with both the study and control arm. The symptomatic posterolateral spinal side is OsteoStrux and the contralateral posterolateral spinal side is local autograft.
11149782|NCT01873586|EG000|Reported Event|All Patients|Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft). Adverse events are unable to be distinguished per posterolateral gutter or spinal level and therefore results are submitted on a per patient basis.
11149783|NCT01873729|BG000|Baseline|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
11149784|NCT01873729|FG000|Participant Flow|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
11149785|NCT01873729|OG000|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)~Naltrexone: Adults with ADHD"
11149786|NCT01873729|EG000|Reported Event|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
11149787|NCT01873742|BG000|Baseline|The Use of STIC Feedback System|This condition included the use of the STIC feedback system.
11149788|NCT01873742|BG001|Baseline|Treatment as Usual|This condition did not include the use of the STIC feedback system.
11149789|NCT01873742|BG002|Baseline|Total|Total of all reporting groups
11149790|NCT01873742|FG000|Participant Flow|The Use of STIC Feedback System|This condition included the use of the STIC feedback system. This implied that before every therapy session clients completed the STIC questionnaire that was processed into a report that was sent to the client's therapist. He or she used this report to prepare for the session, for instance investigating whether treatment progress and process developed satisfactory, and whether there was a need to address topics mentioned in the report. Sharing the results with the client enabled the client to interpret his or her own results and as such user involvement was strengthened.
11149791|NCT01873742|FG001|Participant Flow|Treatment as Usual|This condition did not include the use of the STIC feedback system, in other words, treatment as usual (TAU).
11149792|NCT01873742|OG000|Outcome|The Use of STIC Feedback System|This condition included the use of the STIC feedback system.
11149793|NCT01873742|OG001|Outcome|Treatment as Usual|This condition did not include the use of the STIC feedback system.
11149794|NCT01873742|EG000|Reported Event|The Use of STIC Feedback System|This condition included the use of the STIC feedback system.
11149795|NCT01873742|EG001|Reported Event|Treatment as Usual|This condition did not include the use of the STIC feedback system.
11149796|NCT01873846|BG000|Baseline|Silicone Hydrogel Contact Lens|"Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.~Silicone Hydrogel Contact Lens"
10887437|NCT00500357|OG000|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
11149797|NCT01873846|FG000|Participant Flow|Silicone Hydrogel Contact Lens|"Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.~Silicone Hydrogel Contact Lens"
11142113|NCT01827254|BG000|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
11142114|NCT01827254|FG000|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
11142115|NCT01827254|OG000|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
11142116|NCT01827254|OG000|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non--interventional study.
11142117|NCT01827254|OG000|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
11142118|NCT01827254|OG000|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib, followed by second line treatment with bevacizumab (with interferon),bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
11142119|NCT01827254|OG000|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib, followed by third line treatment with bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
11142120|NCT01827254|EG000|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
11142121|NCT01827267|BG000|Baseline|Neratinib|Neratinib 240 mg
11142122|NCT01827267|BG001|Baseline|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
11142123|NCT01827267|BG002|Baseline|Total|Total of all reporting groups
11142124|NCT01827267|FG000|Participant Flow|Neratinib|Neratinib 240 mg
11142125|NCT01827267|FG001|Participant Flow|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
11142126|NCT01827267|OG000|Outcome|Neratinib|Neratinib 240 mg
11142127|NCT01827267|OG001|Outcome|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
11142128|NCT01827267|EG000|Reported Event|Neratinib|Neratinib 240 mg
11142129|NCT01827267|EG001|Reported Event|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
11142130|NCT01827267|EG002|Reported Event|Ner+Tem Post Crossover|Neratinib 240 mg + Temsirolimus 15 mg for subjects who crossed over from Neratinb 240 mg arm
11142131|NCT01827306|BG000|Baseline|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
11142132|NCT01827306|BG001|Baseline|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
11142133|NCT01827306|BG002|Baseline|Total|Total of all reporting groups
11142134|NCT01827306|FG000|Participant Flow|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
11142135|NCT01827306|FG001|Participant Flow|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
11142136|NCT01827306|OG000|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
11142137|NCT01827306|OG001|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
11142138|NCT01827306|EG000|Reported Event|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
10887438|NCT00500357|OG000|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
11142139|NCT01827306|EG001|Reported Event|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
11142140|NCT01827319|BG000|Baseline|Received TMR and Enrolled in ANGINA RELIEF Registry|
11142141|NCT01827319|FG000|Participant Flow|Received TMR and Enrolled in ANGINA RELIEF Registry|
11142142|NCT01827319|OG000|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
11142143|NCT01827319|EG000|Reported Event|Received TMR and Enrolled in ANGINA RELIEF Registry|
11142144|NCT01827332|BG000|Baseline|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
11142145|NCT01827332|BG001|Baseline|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
11142146|NCT01827332|BG002|Baseline|Total|Total of all reporting groups
11142147|NCT01827332|FG000|Participant Flow|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
11142148|NCT01827332|FG001|Participant Flow|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
11142149|NCT01827332|OG000|Outcome|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
11142150|NCT01827332|OG001|Outcome|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
11142151|NCT01827332|EG000|Reported Event|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
11142152|NCT01827332|EG001|Reported Event|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
11142153|NCT01827358|BG000|Baseline|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
11142154|NCT01827358|BG001|Baseline|No Mupirocin (Control)|Participants received no treatment or placebo
11142155|NCT01827358|BG002|Baseline|Total|Total of all reporting groups
11142156|NCT01827358|FG000|Participant Flow|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
11142157|NCT01827358|FG001|Participant Flow|No Mupirocin (Control)|Participants received no treatment or placebo
11142158|NCT01827358|OG000|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
11142159|NCT01827358|OG001|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
11142160|NCT01827358|EG000|Reported Event|Mupirocin (Treatment)|Participants receive a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
11142161|NCT01827358|EG001|Reported Event|No Mupirocin (Control)|Participants received no treatment and no placebo.
11142162|NCT01827371|BG000|Baseline|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
11142163|NCT01827371|BG001|Baseline|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
11142164|NCT01827371|BG002|Baseline|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
11142165|NCT01827371|BG003|Baseline|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
11142166|NCT01827371|BG004|Baseline|Total|Total of all reporting groups
11142167|NCT01827371|FG000|Participant Flow|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
11142168|NCT01827371|FG001|Participant Flow|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
11142169|NCT01827371|FG002|Participant Flow|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
11142170|NCT01827371|FG003|Participant Flow|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
11142171|NCT01827371|OG000|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
11142172|NCT01827371|OG001|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
11142173|NCT01827371|OG002|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
11142174|NCT01827371|OG003|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
11142175|NCT01827371|EG000|Reported Event|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
11142176|NCT01827371|EG001|Reported Event|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
11142177|NCT01827371|EG002|Reported Event|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
11142178|NCT01827371|EG003|Reported Event|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
11142179|NCT01827462|BG000|Baseline|18-30 Years Old at Enrollment|"Participants receive the licensed annual, Fluzone®~This vaccine is given intramuscularly"
11142180|NCT01827462|BG001|Baseline|60-79 Years Old at Enrollment|"Participants receive the licensed annual vaccine, Fluzone®~This vaccine is given intramuscularly"
11142181|NCT01827462|BG002|Baseline|80-100 Years Old at Enrollment|"Participants receive the licensed annual vaccine, Fluzone® or High Dose Fluzone®~This vaccine is given intramuscularly"
11142182|NCT01827462|BG003|Baseline|Total|Total of all reporting groups
11142183|NCT01827462|FG000|Participant Flow|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
11142184|NCT01827462|FG001|Participant Flow|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
11142185|NCT01827462|FG002|Participant Flow|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
11142186|NCT01827462|OG000|Outcome|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
11142187|NCT01827462|OG001|Outcome|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
11142188|NCT01827462|OG002|Outcome|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
11142189|NCT01827462|OG000|Outcome|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through 2013-2014 then received licensed annual quadrivalent Fluzone.~This vaccine is given intramuscularly"
11142190|NCT01827462|OG001|Outcome|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose.~This vaccine is given intramuscularly"
11142191|NCT01827462|OG002|Outcome|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose.~This vaccine is given intramuscularly"
11142192|NCT01827462|EG000|Reported Event|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed quadrivalent vaccine, Fluzone starting with the 2014-2015 season.~This vaccine is given intramuscularly"
11142193|NCT01827462|EG001|Reported Event|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season.~This vaccine is given intramuscularly"
11142194|NCT01827462|EG002|Reported Event|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season.~This vaccine is given intramuscularly"
11142195|NCT01827475|BG000|Baseline|Ibuprofen|Ibuprofen 800 mg
11142196|NCT01827475|BG001|Baseline|Acetaminophen|Acetaminophen 1 gm
11142197|NCT01827475|BG002|Baseline|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
11142198|NCT01827475|BG003|Baseline|Total|Total of all reporting groups
11142199|NCT01827475|FG000|Participant Flow|Ibuprofen|Ibuprofen 800 mg
11142200|NCT01827475|FG001|Participant Flow|Acetaminophen|Acetaminophen 1 gm
11142201|NCT01827475|FG002|Participant Flow|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
11142202|NCT01827475|OG000|Outcome|Ibuprofen|Ibuprofen 800 mg
11142203|NCT01827475|OG001|Outcome|Acetaminophen|Acetaminophen 1 gm
11142204|NCT01827475|OG002|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
11142205|NCT01827475|EG000|Reported Event|Ibuprofen|Ibuprofen 800 mg
11142206|NCT01827475|EG001|Reported Event|Acetaminophen|Acetaminophen 1 gm
11142207|NCT01827475|EG002|Reported Event|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
11142208|NCT01827592|BG000|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142209|NCT01827592|BG001|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142210|NCT01827592|BG002|Baseline|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142211|NCT01827592|BG003|Baseline|Total|Total of all reporting groups
11142212|NCT01827592|FG000|Participant Flow|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.
11142213|NCT01827592|FG001|Participant Flow|EBX 5|Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.
11142214|NCT01827592|FG002|Participant Flow|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142215|NCT01827592|OG000|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142216|NCT01827592|OG001|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142217|NCT01827592|OG002|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142218|NCT01827592|EG000|Reported Event|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142219|NCT01827592|EG001|Reported Event|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142220|NCT01827592|EG002|Reported Event|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
11142221|NCT01827670|BG000|Baseline|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
11142222|NCT01827670|BG001|Baseline|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
11142223|NCT01827670|BG002|Baseline|Total|Total of all reporting groups
11142224|NCT01827670|FG000|Participant Flow|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds .
11142225|NCT01827670|FG001|Participant Flow|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
11142226|NCT01827670|OG000|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
11142227|NCT01827670|OG001|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
11142228|NCT01827670|OG001|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
11142229|NCT01827670|OG000|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 mililiter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
11142230|NCT01827670|OG001|Outcome|Test Dentrifice (0.454% Stannous Fluoride Dentifrice)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
11142231|NCT01827670|OG001|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
11142232|NCT01827670|OG001|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
11142233|NCT01827670|EG000|Reported Event|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
11142234|NCT01827670|EG001|Reported Event|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
11142235|NCT01827787|BG000|Baseline|Cohort 1: HR+/HER2-|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142236|NCT01827787|BG001|Baseline|Cohort 2: TNBC|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142237|NCT01827787|BG002|Baseline|Total|Total of all reporting groups
11142238|NCT01827787|FG000|Participant Flow|Cohort 1: HR+/HER2-|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142239|NCT01827787|FG001|Participant Flow|Cohort 2: TNBC|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142240|NCT01827787|OG000|Outcome|Cohort 1: HR+/HER2-|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142241|NCT01827787|OG001|Outcome|Cohort 2: TNBC|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142242|NCT01827787|OG000|Outcome|Combined Cohort 1: HR+/HER2- and Cohort 2: TNBC|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142243|NCT01827787|OG000|Outcome|Combined Group (Hormone Receptor Positive and Triple Negative)|"Eribulin Monotherapy~Eribulin: Intravenously on Day 1 and 8 of each cycle"
11142244|NCT01827787|OG000|Outcome|Combine Cohort 1: HR+/HER2- and Cohort 2: TNBC|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142245|NCT01827787|EG000|Reported Event|Cohort 1: HR+/HER2-|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142246|NCT01827787|EG001|Reported Event|Cohort 2: TNBC|"Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle~Participants remained on single agent eribulin until disease progression or withdrawal for other reasons."
11142247|NCT01827839|BG000|Baseline|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
11142248|NCT01827839|FG000|Participant Flow|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
11142249|NCT01827839|OG000|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11142250|NCT01827839|OG001|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11142251|NCT01827839|OG002|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11142252|NCT01827839|OG003|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11142253|NCT01827839|OG000|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
11142254|NCT01827839|OG000|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11142255|NCT01827839|OG001|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11142256|NCT01827839|OG002|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11142257|NCT01827839|EG000|Reported Event|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
11142258|NCT01827930|BG000|Baseline|Imatinib 600 (Randomized Trial)|"Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po~Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML"
11142259|NCT01827930|BG001|Baseline|Imatinib 400 (Randomized Trial)|"Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po~Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML"
11142260|NCT01827930|BG002|Baseline|Imatinib400 (Parallel Cohort)|"Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po~Imatinib Mesylate: Imatinib Mesylate for CP CML"
11142261|NCT01827930|BG003|Baseline|Total|Total of all reporting groups
11142262|NCT01827930|FG000|Participant Flow|Imatinib 600 (Randomized Trial)|"Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po~Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML"
11142263|NCT01827930|FG001|Participant Flow|Imatinib 400 (Randomized Trial)|"Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po~Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML"
11142264|NCT01827930|FG002|Participant Flow|Imatinib400 (Cohort)|"Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po~Imatinib Mesylate: Imatinib Mesylate for CP CML"
11142265|NCT01827930|OG000|Outcome|Imatinib 600 (Randomized Trial)|"Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po~Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML"
11142266|NCT01827930|OG001|Outcome|Imatinib 400 (Randomized Trial)|"Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po~Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML"
11142267|NCT01827930|OG002|Outcome|Imatinib400 (Parallel Cohort)|"Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po~Imatinib Mesylate: Imatinib Mesylate for CP CML"
11142268|NCT01827930|EG000|Reported Event|Imatinib 600 (Randomized Trial)|"Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po~Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML"
11142269|NCT01827930|EG001|Reported Event|Imatinib 400 (Randomized Trial)|"Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po~Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML"
11142270|NCT01827930|EG002|Reported Event|Imatinib400 (Parallel Cohort)|"Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po~Imatinib Mesylate: Imatinib Mesylate for CP CML"
11142271|NCT01827943|BG000|Baseline|Temsirolimus|"Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.~Temsirolimus: Temsirolimus"
11142272|NCT01827943|FG000|Participant Flow|Temsirolimus|"Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.~Temsirolimus: Temsirolimus"
11142273|NCT01827943|OG000|Outcome|Temsirolimus|"Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.~Temsirolimus: Temsirolimus"
11142274|NCT01827943|EG000|Reported Event|Temsirolimus|"Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.~Temsirolimus: Temsirolimus"
11142275|NCT01828034|BG000|Baseline|Cohort 1|Cohort 1 Phase I, Dose Level 1 - MEK162 25 mg
11142276|NCT01828034|BG001|Baseline|Cohort 2|Cohort 2 Phase I, Dose Level 2 - MEK162 45mg
11142277|NCT01828034|BG002|Baseline|Cohort 3|Cohort 3 Phase I, Dose Level 3 / Phase II - MTD mg
11142278|NCT01828034|BG003|Baseline|Cohort 4|Cohort 4 Phase II only, MTD mg
11142279|NCT01828034|BG004|Baseline|Total|Total of all reporting groups
11142280|NCT01828034|FG000|Participant Flow|Cohort 1|"Cohort 1~Phase I, Dose Level 1 - MEK162 25 mg"
11142281|NCT01828034|FG001|Participant Flow|Cohort 2|Cohort 2 Phase I, Dose Level 2 - MEK162 45mg
11142282|NCT01828034|FG002|Participant Flow|Cohort 3|Cohort 3 Phase I, Dose Level 3 / Phase II - MTD mg
11142283|NCT01828034|FG003|Participant Flow|Cohort 4|Cohort 4 Phase II only, MTD mg
11149798|NCT01873846|OG000|Outcome|Silicone Hydrogel Contact Lens|"Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.~Silicone Hydrogel Contact Lens"
11142284|NCT01828034|OG000|Outcome|Gemcitabine, Cisplatin and MEK162|Phase I component of the study, a classic 3+3 cohort dose escalation scheme will be used to identify the MTD of MEK162 when administered with gemcitabine at dose 800 mg/m2 and cisplatin given at dose 20 mg/m2 week 2 & 3 of a 3 week cycle. The final cohort will receive gemcitabine 1000mg/m2 and cisplatin 20mg/m2 week 2 and 3 of a 3 week cycle in combination with MEK162 at the MTD as determined above. In the phase II part of the study, patients will receive MEK162 at the MTD dose plus gemcitabine and cisplatin at the dose level determined acceptable in the phase I portion. In the phase II part of the study, patients will receive MEK162 at 45mg BID plus gemcitabine (800 mg/m2) and cisplatin (20 mg/m2) as determined by the phase I portion.
11142285|NCT01828034|EG000|Reported Event|Cohort 1|Cohort 1 Phase I, Dose Level 1 - MEK162 25 mg
11142286|NCT01828034|EG001|Reported Event|Cohort 2|Cohort 2 Phase I, Dose Level 2 - MEK162 45mg
11142287|NCT01828034|EG002|Reported Event|Cohort 3|Cohort 3 Phase I, Dose Level 3 / Phase II - MTD mg
11142288|NCT01828034|EG003|Reported Event|Cohort 4|Cohort 4 Phase II only, MTD mg
11142289|NCT01828073|BG000|Baseline|Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142290|NCT01828073|BG001|Baseline|Cohort 2: LBW Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142291|NCT01828073|BG002|Baseline|Total|Total of all reporting groups
11142292|NCT01828073|FG000|Participant Flow|Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor.~Raltegravir: No study-specific drugs was given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142293|NCT01828073|FG001|Participant Flow|Cohort 2: LBW Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142294|NCT01828073|OG000|Outcome|Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142295|NCT01828073|OG001|Outcome|Cohort 2: LBW Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142296|NCT01828073|OG000|Outcome|Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. The group also includes the mothers of these infants.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142297|NCT01828073|OG001|Outcome|Cohort 2: LBW Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. The group also includes the mothers of these infants.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142298|NCT01828073|OG000|Outcome|Cohort 1 Infants With UGT1A1 Mutation|Cohort 1 (full term) infants with the presence of UGT1A1 *28/*28 genetic variant
11142299|NCT01828073|OG001|Outcome|Cohort 1 Infants With Normal UGT1A1 Phenotype|Cohort 1 (full term) infants with the absence of UGT1A1 *28/*28 genetic variant
11142300|NCT01828073|OG002|Outcome|Cohort 2 Infants With UGT1A1 Mutation|Cohort 2 (LBW) infants with the presence of UGT1A1 *28/*28 genetic variant
11142301|NCT01828073|OG003|Outcome|Cohort 2 Infants With Normal UGT1A1 Phenotype|Cohort 2 (LBW) infants with the absence of the UGT1A1 *28/*28 genetic variant
11142302|NCT01828073|EG000|Reported Event|Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142303|NCT01828073|EG001|Reported Event|Cohort 2: LBW Infants Exposed in Utero to Maternal RAL|"Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery.~Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study."
11142304|NCT01828164|BG000|Baseline|All Study Participants|As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
11142305|NCT01828164|FG000|Participant Flow|All Study Participants|As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
11142306|NCT01828164|OG000|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
11142307|NCT01828164|OG001|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
11142308|NCT01828164|OG000|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
11142309|NCT01828164|OG001|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
11142310|NCT01828164|EG000|Reported Event|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
11142311|NCT01828164|EG001|Reported Event|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
11142312|NCT01828216|BG000|Baseline|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
11142313|NCT01828216|BG001|Baseline|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
11142314|NCT01828216|BG002|Baseline|Total|Total of all reporting groups
11142315|NCT01828216|FG000|Participant Flow|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
11142316|NCT01828216|FG001|Participant Flow|Ambulatory Sleep Study|The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
11142317|NCT01828216|OG000|Outcome|In-hospital CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
11142318|NCT01828216|OG001|Outcome|Ambulatory CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
11142319|NCT01828216|OG000|Outcome|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
11142320|NCT01828216|OG001|Outcome|Ambulatory Sleep Study|Home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
11142321|NCT01828216|EG000|Reported Event|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
11142322|NCT01828216|EG001|Reported Event|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
11142323|NCT01828255|BG000|Baseline|Slow Progressors|VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
11142324|NCT01828255|BG001|Baseline|Fast Progressors|pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
11142325|NCT01828255|BG002|Baseline|Total|Total of all reporting groups
11142326|NCT01828255|FG000|Participant Flow|Fast Progressors|pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
11142327|NCT01828255|FG001|Participant Flow|Slow Progressors|VF MD rate of change more positive than -0.5 dB/year with no significant point defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01wise progression
11142328|NCT01828255|OG000|Outcome|Fast Progressors|Patients with a fast rate of progression (<-1dB/y)
11142329|NCT01828255|OG001|Outcome|Slow Progressors|Patients with a slow rate of progression (>-1dB/y)
11142330|NCT01828255|OG000|Outcome|Fast|Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
11142331|NCT01828255|OG001|Outcome|Slow|VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
11142332|NCT01828255|EG000|Reported Event|Fast Progressors|Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
11142333|NCT01828255|EG001|Reported Event|Slow Progressors|VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
11142334|NCT01828281|BG000|Baseline|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
11142335|NCT01828281|BG001|Baseline|Control|subtherapeutic CPAP using 4 cm water
11142336|NCT01828281|BG002|Baseline|Total|Total of all reporting groups
11142337|NCT01828281|FG000|Participant Flow|Therapeutic CPAP|The continuous positive airway pressure (CPAP) level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
11142338|NCT01828281|FG001|Participant Flow|Control|subtherapeutic CPAP using 4 cm water
11142339|NCT01828281|OG000|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
11142340|NCT01828281|OG001|Outcome|Control|"subtherapeutic CPAP using 4 cm water~CPAP: All subjects will undergo ultrasound examination of the abdomen the day after overnight PSG and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water."
11142341|NCT01828281|OG001|Outcome|Control|subtherapeutic CPAP using 4 cm water
11142342|NCT01828281|EG000|Reported Event|Therapeutic CPAP|The CPAP level for each patient in the therapeutic CPAP arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
11142343|NCT01828281|EG001|Reported Event|Control|subtherapeutic CPAP using 4 cm water
11142344|NCT01828476|BG000|Baseline|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
11142345|NCT01828476|BG001|Baseline|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
11142346|NCT01828476|BG002|Baseline|Total|Total of all reporting groups
11142347|NCT01828476|FG000|Participant Flow|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
11142348|NCT01828476|FG001|Participant Flow|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
11142349|NCT01828476|OG000|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
11142350|NCT01828476|OG001|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
11142351|NCT01828476|OG000|Outcome|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
11142352|NCT01828476|OG001|Outcome|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
11142353|NCT01828476|EG000|Reported Event|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
11142354|NCT01828476|EG001|Reported Event|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
11142355|NCT01828515|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Vilazodone and hydrocortisone or placebo and hydrocortisone.
11142356|NCT01828515|FG000|Participant Flow|Vilazodone and Hydrocortisone,Then Placebo and Hydrocortisone|Vilazodone was initiated at 10 mg/day for 7 days and increased to 20 mg/day for 7 days. After that time an additional increase to 40 mg/day for 5 days (totaling 19 days). On the 2nd day of the 40 mg a day portion, 160 mg of hydrocortisone/day was given for 4 days. After a washout period of 23 days, placebo was given for 19 days and hydrocortisone was given for 4 days.
11142357|NCT01828515|FG001|Participant Flow|Placebo and Hydrocortisone, Then Vilazodone and Hydrocortisone|Placebo was given for 19 days and hydrocortisone was given for 4 days. After a washout period of 23 days, Vilazodone was initiated at 10 mg/day for 7 days and increased to 20 mg/day for 7 days. After that time an additional increase to 40 mg/day for 5 days (totaling 19 days). On the 2nd day of the 40 mg a day portion, 160 mg of hydrocortisone/day was given for 4 days.
11142358|NCT01828515|OG000|Outcome|Vilazodone and Hydrocortisone|Vilazodone was initiated at 10 mg/day for 7 days and increased to 20 mg/day for 7 days. After that time an additional increase to 40 mg/day for 5 days (totaling 19 days). On the 2nd day of the 40 mg a day portion, 160 mg of hydrocortisone/day was given for 4 days.
11142359|NCT01828515|OG001|Outcome|Placebo and Hydrocortisone|Placebo was given for 19 days and hydrocortisone was given for 4 days.
11142360|NCT01828515|EG000|Reported Event|Vilazodone and Hydrocortisone|Vilazodone was initiated at 10 mg/day for 7 days and increased to 20 mg/day for 7 days. After that time an additional increase to 40 mg/day for 5 days (totaling 19 days).
11142361|NCT01828515|EG001|Reported Event|Placebo and Hydrocortisone|Placebo group received medication in identical color/sizes as the Vilazodone group. Placebo was given for 19 days.
11142362|NCT01828554|BG000|Baseline|Xeloda (Capecitabine)|"Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.~Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage."
11142363|NCT01828554|FG000|Participant Flow|Xeloda (Capecitabine)|"Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.~Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage."
11142364|NCT01828554|OG000|Outcome|Xeloda (Capecitabine)|"Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.~Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage."
11149799|NCT01873846|EG000|Reported Event|Silicone Hydrogel Contact Lens|"Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.~Silicone Hydrogel Contact Lens"
11149800|NCT01873859|BG000|Baseline|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
11142365|NCT01828554|EG000|Reported Event|Xeloda (Capecitabine)|"Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.~Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage."
11142366|NCT01828567|BG000|Baseline|Intervention|"Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment~Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan."
11142367|NCT01828567|BG001|Baseline|Control|Usual care
11142368|NCT01828567|BG002|Baseline|Total|Total of all reporting groups
11142369|NCT01828567|FG000|Participant Flow|Intervention|"Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment~Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan."
11142370|NCT01828567|FG001|Participant Flow|Control|Usual care
11142371|NCT01828567|OG000|Outcome|Intervention|"Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment~Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan."
11142372|NCT01828567|OG001|Outcome|Control|Usual care
11142373|NCT01828567|EG000|Reported Event|Intervention|"Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment~Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan."
11142374|NCT01828567|EG001|Reported Event|Control|Usual care
11142375|NCT01828593|BG000|Baseline|Placebo|Matching Placebo
11142376|NCT01828593|BG001|Baseline|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142377|NCT01828593|BG002|Baseline|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142378|NCT01828593|BG003|Baseline|Total|Total of all reporting groups
11142379|NCT01828593|FG000|Participant Flow|Placebo|"Matching Placebo~Following 4 weeks in placebo-controlled phase were randomized to either SBI 2.5 g or SBI 5.0 g"
11142380|NCT01828593|FG001|Participant Flow|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142381|NCT01828593|FG002|Participant Flow|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142382|NCT01828593|OG000|Outcome|Placebo|Matching Placebo
11142383|NCT01828593|OG001|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142384|NCT01828593|OG002|Outcome|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142385|NCT01828593|OG001|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142386|NCT01828593|OG002|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142387|NCT01828593|OG000|Outcome|CD4 + T Cell Counts|
11142388|NCT01828593|OG001|Outcome|CD8 + T Cell Counts|
11142389|NCT01828593|EG000|Reported Event|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142390|NCT01828593|EG001|Reported Event|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
11142391|NCT01828983|BG000|Baseline|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
11142392|NCT01828983|BG001|Baseline|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
11142393|NCT01828983|BG002|Baseline|Total|Total of all reporting groups
11142394|NCT01828983|FG000|Participant Flow|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
11142395|NCT01828983|FG001|Participant Flow|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
11142396|NCT01828983|OG000|Outcome|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
11142397|NCT01828983|OG001|Outcome|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
11142398|NCT01828983|EG000|Reported Event|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
11142399|NCT01828983|EG001|Reported Event|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
11142400|NCT01829048|BG000|Baseline|PF-02545920 (Cohort 1)|Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
11142401|NCT01829048|BG001|Baseline|PF-02545920 (Cohort 2)|Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
11142402|NCT01829048|BG002|Baseline|Placebo (Cohorts 1 and 2)|Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
11142403|NCT01829048|BG003|Baseline|PF-02545920 (Cohort 3)|Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
11142404|NCT01829048|BG004|Baseline|Placebo (Cohort 3)|Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
11142405|NCT01829048|BG005|Baseline|Total|Total of all reporting groups
11142406|NCT01829048|FG000|Participant Flow|PF-02545920 (Cohort 1)|Participants received PF-02545920 15 milligram (mg) orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
11142407|NCT01829048|FG001|Participant Flow|PF-02545920 (Cohort 2)|Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
11142408|NCT01829048|FG002|Participant Flow|Placebo (Cohorts 1 and 2)|Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
11142409|NCT01829048|FG003|Participant Flow|PF-02545920 (Cohort 3)|Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
11142410|NCT01829048|FG004|Participant Flow|Placebo (Cohort 3)|Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
11142411|NCT01829048|OG000|Outcome|PF-02545920 (Cohort 1)|Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
11142412|NCT01829048|OG001|Outcome|PF-02545920 (Cohort 2)|Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
11142413|NCT01829048|OG002|Outcome|Placebo (Cohorts 1 and 2)|Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
11142414|NCT01829048|OG000|Outcome|PF-02545920 (Cohort 3)|Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
11142415|NCT01829048|OG001|Outcome|Placebo (Cohort 3)|Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
11142416|NCT01829048|OG000|Outcome|PF-02545920 (Cohort 1)|Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
11142417|NCT01829048|EG000|Reported Event|PF-02545920 (Cohort 1)|Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
11142418|NCT01829048|EG001|Reported Event|PF-02545920 (Cohort 2)|Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
11142419|NCT01829048|EG002|Reported Event|Placebo (Cohorts 1 and 2)|Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
11142420|NCT01829048|EG003|Reported Event|PF-02545920 (Cohort 3)|Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
11142421|NCT01829048|EG004|Reported Event|Placebo (Cohort 3)|Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
11142422|NCT01829113|BG000|Baseline|OGX-427|"OGX-427: Three loading doses of OGX-427 at 600mg intravenously (IV) will be administered over 9 days.~Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142423|NCT01829113|BG001|Baseline|Placebo|"Placebo: Three loading doses of placebo will be administered intravenously (IV) over 9 days.~Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142424|NCT01829113|BG002|Baseline|Total|Total of all reporting groups
11142425|NCT01829113|FG000|Participant Flow|OGX-427|"OGX-427: Three loading doses of OGX-427 at 600mg intravenously (IV) will be administered over 9 days.~Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142426|NCT01829113|FG001|Participant Flow|Placebo|"Placebo: Three loading doses of placebo will be administered intravenously (IV) over 9 days.~Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142427|NCT01829113|OG000|Outcome|OGX-427|"OGX-427: Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1.~Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients with objective response or stable disease after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142428|NCT01829113|OG001|Outcome|Placebo|"Placebo: Three loading doses of placebo will be administered IV Days -9 to -1.~Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients with objective response or stable disease after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142429|NCT01829113|OG000|Outcome|OGX-427|"OGX-427: Three loading doses of OGX-427 at 600mg intravenously (IV) will be administered over 9 days.~Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142430|NCT01829113|OG001|Outcome|Placebo|"Placebo: Three loading doses of placebo will be administered intravenously (IV) over 9 days.~Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142431|NCT01829113|EG000|Reported Event|OGX-427|"OGX-427: Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1.~Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients with objective response or stable disease after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142432|NCT01829113|EG001|Reported Event|Placebo|"Placebo: Three loading doses of placebo will be administered IV Days -9 to -1.~Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.~Patients with objective response or stable disease after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression."
11142433|NCT01829165|BG000|Baseline|rTMS Treatment|"rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects.~rTMS Treatment: MRI-compatible TMS stimulator"
11142434|NCT01829165|BG001|Baseline|Sham Treatment|"Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects.~Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.~rTMS Treatment: MRI-compatible TMS stimulator"
11142435|NCT01829165|BG002|Baseline|Total|Total of all reporting groups
11142436|NCT01829165|FG000|Participant Flow|rTMS Treatment|"Rapid transcranial magnetic stimulation (rTMS) was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own functional magnetic resonance imaging (fMRI) images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects.~rTMS Treatment: MRI-compatible TMS stimulator"
11142437|NCT01829165|FG001|Participant Flow|Sham Treatment|"Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects.~Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.~rTMS Treatment: MRI-compatible TMS stimulator"
11142438|NCT01829165|OG000|Outcome|rTMS Treatment|"rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects.~rTMS Treatment: MRI-compatible TMS stimulator"
11149801|NCT01873859|BG001|Baseline|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
11149802|NCT01873859|BG002|Baseline|Total|Total of all reporting groups
11149803|NCT01873859|FG000|Participant Flow|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
11142439|NCT01829165|OG001|Outcome|Sham Treatment|"Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects.~Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.~rTMS Treatment: MRI-compatible TMS stimulator"
11142440|NCT01829165|EG000|Reported Event|rTMS Treatment|"rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects.~rTMS Treatment: MRI-compatible TMS stimulator"
11142441|NCT01829165|EG001|Reported Event|Sham Treatment|"Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects.~Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.~rTMS Treatment: MRI-compatible TMS stimulator"
11142442|NCT01829191|BG000|Baseline|Test Lens A|Test lenses will be worn in a daily wear modality
11142443|NCT01829191|BG001|Baseline|Test Lens C|Test lens will be worn in a daily wear modality
11142444|NCT01829191|BG002|Baseline|Total|Total of all reporting groups
11142445|NCT01829191|FG000|Participant Flow|Test Lens A|Test lenses will be worn in a daily wear modality
10879728|NCT00459368|OG000|Outcome|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
11142446|NCT01829191|FG001|Participant Flow|Test Lens C|Test lens will be worn in a daily wear modality
11142447|NCT01829191|OG000|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
11142448|NCT01829191|OG001|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
11142449|NCT01829191|EG000|Reported Event|All Subjects|All subjects who eligible to participate in the study whether or not randomized to the study arm.
11142450|NCT01829217|BG000|Baseline|Sunitinib|"42 day cycle, taken orally every day for the first 28 days followed by 14 days off~Sunitinib"
11142451|NCT01829217|FG000|Participant Flow|Sunitinib|"42 day cycle, taken orally every day for the first 28 days followed by 14 days off~Sunitinib"
11142452|NCT01829217|OG000|Outcome|Sunitinib|"42 day cycle, taken orally every day for the first 28 days followed by 14 days off~Sunitinib"
11142453|NCT01829217|EG000|Reported Event|Sunitinib|"42 day cycle, taken orally every day for the first 28 days followed by 14 days off~Sunitinib"
11142454|NCT01829230|BG000|Baseline|Test Lens C|Test lens C from previous study
11142455|NCT01829230|BG001|Baseline|Test Lens A|Test lens A from previous study
11142456|NCT01829230|BG002|Baseline|Total|Total of all reporting groups
11142457|NCT01829230|FG000|Participant Flow|Test Lens C|Test lens C from previous study
11142458|NCT01829230|FG001|Participant Flow|Test Lens A|Test lens A from previous study
11142459|NCT01829230|OG000|Outcome|Test Lens C|Test lens C from the previous study
11142460|NCT01829230|OG001|Outcome|Test Lens A|Test lens A from the previous study
11142461|NCT01829230|EG000|Reported Event|Test Lens C|Test lens C from previous study
11142462|NCT01829230|EG001|Reported Event|Test Lens A|Test lens A from previous study
11142463|NCT01829243|BG000|Baseline|Subjects Who Completed the Study|
11142464|NCT01829243|FG000|Participant Flow|Milnacipran First, Then Placebo|Patients randomized to receiving milnacipran first.
11142465|NCT01829243|FG001|Participant Flow|Placebo First, Then Milnacipran|Patients randomized to receive placebo first
11142466|NCT01829243|OG000|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
11142467|NCT01829243|OG001|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
11142468|NCT01829243|OG000|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran
11142469|NCT01829243|OG000|Outcome|Milnacipran|Data is summarize for all patients while they were taking the Milnacipran.
11142470|NCT01829243|EG000|Reported Event|Milnacipran|Adverse events in this group occurred while subjects were taking Milnacipran.
11142471|NCT01829243|EG001|Reported Event|Placebo|Adverse events in this group occurred while subjects were taking Placebo.
11142472|NCT01829295|BG000|Baseline|Methotrexate|"oral methotrexate~Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11142473|NCT01829295|BG001|Baseline|Mycophenolate Mofetil|"oral mycophenolate mofetil~Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11142474|NCT01829295|BG002|Baseline|Total|Total of all reporting groups
11142475|NCT01829295|FG000|Participant Flow|Methotrexate Only|"oral methotrexate~Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.~These patients never switched over to receive mycophenolate mofetil as they were a treatment success at Month 6."
11142476|NCT01829295|FG001|Participant Flow|Mycophenolate Mofetil Only|"oral mycophenolate mofetil~Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.~These patients never switched over to receive mycophenolate mofetil as they were a treatment success at Month 6."
11142477|NCT01829295|FG002|Participant Flow|Methotrexate, Then Mycophenolate Mofetil|"first received oral methotrexate~Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.~then switched over to receive oral mycophenolate mofetil after failing with oral methotrexate~Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Followed the same prednisone schedule as described in the Methotrexate only and Mycophenolate Mofetil only groups."
11142478|NCT01829295|FG003|Participant Flow|Mycophenolate Mofetil, Then Methotrexate|"first received oral mycophenolate mofetil~Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.~then switched over to receive oral mycophenolate mofetil after failing with oral mycophenolate mofetil~Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)~Followed the same prednisone schedule as described in the Methotrexate only and Mycophenolate Mofetil only groups."
11142479|NCT01829295|OG000|Outcome|Methotrexate|"oral methotrexate~Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11142480|NCT01829295|OG001|Outcome|Mycophenolate Mofetil|"oral mycophenolate mofetil~Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11142481|NCT01829295|OG000|Outcome|Methotrexate|oral methotrexate Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week) Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.
11142482|NCT01829295|OG001|Outcome|Mycophenolate Mofetil|"oral mycophenolate mofetil Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11142483|NCT01829295|OG000|Outcome|Switched Over to Methotrexate|"oral methotrexate~Patients were randomized to mycophenolate but were a treatment failure in Phase I, 0-6 Months and switched over to received methotrexate.~Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11142484|NCT01829295|OG001|Outcome|Switched Over to Mycophenolate Mofetil|"oral mycophenolate mofetil~Patients were randomized to methotrexate but were a treatment failure in Phase I, 0-6 Months and switched over to received mycophenolate mofetil.~Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11149804|NCT01873859|FG001|Participant Flow|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
11142485|NCT01829295|EG000|Reported Event|Methotrexate|"oral methotrexate~Patients randomized to receive oral methotrexate in Phase I, 0-6 Months.~Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11142486|NCT01829295|EG001|Reported Event|Mycophenolate Mofetil|"oral mycophenolate mofetil~Patients randomized to receive oral mycophenolate mofetil in Phase I, 0-6 Months.~Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study."
11142487|NCT01829347|BG000|Baseline|ELAD (Plus Standard of Care)|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 10 days, followed by Standard of Care treatment through Study Day 91.
11142488|NCT01829347|BG001|Baseline|Standard of Care (Control)|Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
11142489|NCT01829347|BG002|Baseline|Total|Total of all reporting groups
11142490|NCT01829347|FG000|Participant Flow|ELAD (Plus Standard of Care)|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 10 days, followed by Standard of Care treatment through Study Day 91.
11142491|NCT01829347|FG001|Participant Flow|Standard of Care (Control)|Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
11142492|NCT01829347|OG000|Outcome|ELAD (Plus Standard of Care)|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed standard of care treatment for a period of up to 10 days followed by standard of care treatment through Study Day 91.
11142493|NCT01829347|OG001|Outcome|Standard of Care (Control)|Participants randomized to the Control group received protocol-directed standard of care treatment in accord with AASLD and EASL guidelines for up to 91 days.
11142494|NCT01829347|EG000|Reported Event|ELAD (Plus Standard of Care)|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed standard of care treatment for a period of up to 10 days followed by standard of care treatment through Study Day 91.
11142495|NCT01829347|EG001|Reported Event|Standard of Care (Control)|Participants randomized to the Control group received protocol-directed standard of care treatment in accord with AASLD and EASL guidelines for up to 91 days.
11142496|NCT01829360|BG000|Baseline|Standard Then Alternative: High Dose|Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
11142497|NCT01829360|BG001|Baseline|Alternative: High Dose Then Standard|Treatment 1= dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
11142498|NCT01829360|BG002|Baseline|Alternative: High Dose Frequency Then Standard|Treatment 1= dose 4 x dose frequency 49 Treatment 2 = dose 6 x dose frequency 6
11142499|NCT01829360|BG003|Baseline|Standard Then Alternative: High Dose Frequency|Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
11142500|NCT01829360|BG004|Baseline|Total|Total of all reporting groups
11142501|NCT01829360|FG000|Participant Flow|Standard Then Alternative: High Dose|Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
11142502|NCT01829360|FG001|Participant Flow|Alternative: High Dose Then Standard|Treatment 1= dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
11142503|NCT01829360|FG002|Participant Flow|Alternative: High Dose Frequency Then Standard|Treatment 1= dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
11142504|NCT01829360|FG003|Participant Flow|Standard Then Alternative: High Dose Frequency|Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
11142505|NCT01829360|OG000|Outcome|Standard Then Alternative: High Dose|Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
11142506|NCT01829360|OG001|Outcome|Alternative: High Dose Then Standard|Treatment 1 = dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
11142507|NCT01829360|OG002|Outcome|High Dose Frequency Then Standard|Treatment 1 = dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
11142508|NCT01829360|OG003|Outcome|Standard Then Alternative: High Dose Frequency|Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
11142509|NCT01829360|OG000|Outcome|Standard Then Alternative: High Dose|Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
11142510|NCT01829360|OG001|Outcome|Alternative: High Dose Then Standard|Treatment 1= dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
11142511|NCT01829360|OG002|Outcome|Alternative: High Dose Frequency Then Standard|Treatment 1= dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
11142512|NCT01829360|OG003|Outcome|Standard Then Alternative: High Dose Frequency|Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
11142513|NCT01829360|EG000|Reported Event|Standard Then Alternative: High Dose|Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
11142514|NCT01829360|EG001|Reported Event|Alternative: High Dose Then Standard|Treatment 1 = dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
11142515|NCT01829360|EG002|Reported Event|High Dose Frequency Then Standard|Treatment 1 = dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
11142516|NCT01829360|EG003|Reported Event|Standard Then Alternative: High Dose Frequency|Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
11142517|NCT01829399|BG000|Baseline|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|On the first visit, subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of saline was injected 15 minutes prior to tourniquet inflation.
11142518|NCT01829399|BG001|Baseline|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
11142519|NCT01829399|BG002|Baseline|Total|Total of all reporting groups
11142520|NCT01829399|FG000|Participant Flow|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the first visit and a subcutaneous axillary ring injection with saline on the second visit.
11142521|NCT01829399|FG001|Participant Flow|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with normal saline on the first visit and a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the second visit.
11142522|NCT01829399|OG000|Outcome|Bupivacaine Axillary Ring on 1st Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000.
11142523|NCT01829399|OG001|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline.
11142524|NCT01829399|OG000|Outcome|Bupivacaine Ring 1st Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
11142525|NCT01829399|OG001|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation.
11142526|NCT01829399|EG000|Reported Event|Bupivacaine Axillary Ring|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000
11142527|NCT01829399|EG001|Reported Event|Saline Axillary Ring (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline
11142528|NCT01829425|BG000|Baseline|Hypnotherapy|"Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.~Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study."
11142529|NCT01829425|BG001|Baseline|Anticholinergic Medications|"Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.~Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year."
11142530|NCT01829425|BG002|Baseline|Total|Total of all reporting groups
11142531|NCT01829425|FG000|Participant Flow|Anticholinergic Medications|"Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.~Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year."
11142532|NCT01829425|FG001|Participant Flow|Hypnotherapy|"Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.~Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study."
11142533|NCT01829425|OG000|Outcome|Hypnotherapy|"Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.~Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study."
11149805|NCT01873859|OG000|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
11149806|NCT01873859|OG001|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
11142534|NCT01829425|OG001|Outcome|Anticholinergic Medications|"Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.~Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year."
11142535|NCT01829425|EG000|Reported Event|Hypnotherapy|"Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.~Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study."
11142536|NCT01829425|EG001|Reported Event|Anticholinergic Medications|"Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.~Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year."
11142537|NCT01829464|BG000|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
11142538|NCT01829464|BG001|Baseline|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
11142539|NCT01829464|BG002|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
11142540|NCT01829464|BG003|Baseline|Total|Total of all reporting groups
11142541|NCT01829464|FG000|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
11142542|NCT01829464|FG001|Participant Flow|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
11142543|NCT01829464|FG002|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
11142544|NCT01829464|OG000|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
11142545|NCT01829464|OG001|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
11142546|NCT01829464|OG002|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
11142547|NCT01829464|EG000|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
11142548|NCT01829464|EG001|Reported Event|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
11142549|NCT01829464|EG002|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
11142550|NCT01829503|BG000|Baseline|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
11142551|NCT01829503|FG000|Participant Flow|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
11142552|NCT01829503|OG000|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
11142553|NCT01829503|OG000|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days
11142554|NCT01829503|OG000|Outcome|Decitabine + Cytarabine + Maintenance Therapy|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days. Participants also received decitabine 20mg/m^2 IV daily for 5 days to be given as an outpatient (maintenance therapy) until disease progression (at least one cycle).
11142555|NCT01829503|EG000|Reported Event|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days
11142556|NCT01829516|BG000|Baseline|All Study Participants|This is a crossover study of 39 moderate to heavy social alcohol users who will receive a single dose 40 IU of intranasal oxytocin followed by 40 IU of placebo or vice versa.
11142557|NCT01829516|FG000|Participant Flow|Oxytocin First, Then Placebo|"18 moderate to heavy social alcohol users received a single dose 40 IU of intranasal oxytocin followed by a single dose 40 IU of intranasal placebo.~NOTE: This is a cross-over design and subjects will participate in both arms."
11142558|NCT01829516|FG001|Participant Flow|Placebo First Then Oxytocin|"14 moderate to heavy social alcohol users received a single dose 40 IU of intranasal placebo followed by a single dose 40 IU of intranasal oxytocin.~NOTE: This is a cross-over design and subjects will participate in both arms."
11142559|NCT01829516|OG000|Outcome|Oxytocin|18 moderate to heavy social alcohol users received 40 IU of intranasal oxytocin followed by 40 IU of intranasal placebo and 14 received 40 IU of intranasal placebo first followed by 40 IU of intranasal oxytocin, for a total of 32 participants analyzed.
11142560|NCT01829516|OG001|Outcome|Placebo|14 moderate to heavy social alcohol users received 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin and 18 received 40 IU of intranasal oxytocin first followed by 40 IU of intranasal placebo, for a total of 32 participants analyzed.
11142561|NCT01829516|OG000|Outcome|Oxytocin|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
11142562|NCT01829516|OG001|Outcome|Placebo|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
11142563|NCT01829516|EG000|Reported Event|Oxytocin|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.~Oxytocin"
11142564|NCT01829516|EG001|Reported Event|Placebo|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo.~NOTE: This is a cross-over design and subjects will participate in both arms.~Placebo"
11142565|NCT01829919|BG000|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules~All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
11142566|NCT01829919|FG000|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
11142567|NCT01829919|OG000|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
11142568|NCT01829919|EG000|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules~All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
11142569|NCT01829997|BG000|Baseline|nanOss Bioactive 3D BVF|"Bilateral, instrumented posterolateral fusion surgery where nanOss Bioactive 3D will be hydrated with autologous BMA and placed bilaterally on a bed of local autograft bone spanning the transverse processes of the treated segment. If an interbody fusion is performed, only a PLIF or TLIF with PEEK IBF devices may be performed.~nanOss Bioactive 3D BVF: nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed."
11142570|NCT01829997|FG000|Participant Flow|nanOss Bioactive 3D BVF|"Bilateral, instrumented posterolateral fusion surgery where nanOss Bioactive 3D will be hydrated with autologous BMA and placed bilaterally on a bed of local autograft bone spanning the transverse processes of the treated segment. If an interbody fusion is performed, only a PLIF or TLIF with PEEK IBF devices may be performed.~nanOss Bioactive 3D BVF: nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed."
11142571|NCT01829997|OG000|Outcome|nanOss Bioactive 3D BVF|"Bilateral, instrumented posterolateral fusion surgery where nanOss Bioactive 3D will be hydrated with autologous BMA and placed bilaterally on a bed of local autograft bone spanning the transverse processes of the treated segment. If an interbody fusion is performed, only a PLIF or TLIF with PEEK IBF devices may be performed.~nanOss Bioactive 3D BVF: nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed."
11142572|NCT01829997|EG000|Reported Event|nanOss Bioactive 3D BVF|"Bilateral, instrumented posterolateral fusion surgery where nanOss Bioactive 3D will be hydrated with autologous BMA and placed bilaterally on a bed of local autograft bone spanning the transverse processes of the treated segment. If an interbody fusion is performed, only a PLIF or TLIF with PEEK IBF devices may be performed.~nanOss Bioactive 3D BVF: nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed."
11142573|NCT01830127|BG000|Baseline|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
11142574|NCT01830127|BG001|Baseline|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
11142575|NCT01830127|BG002|Baseline|Total|Total of all reporting groups
11142576|NCT01830127|FG000|Participant Flow|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
11149807|NCT01873859|OG000|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: rise of creatinin 48 hr after recieving contrast media."
11142577|NCT01830127|FG001|Participant Flow|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
11142578|NCT01830127|OG000|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
11142579|NCT01830127|OG001|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
11142580|NCT01830127|EG000|Reported Event|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
11142581|NCT01830127|EG001|Reported Event|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
11142582|NCT01830140|BG000|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
11142583|NCT01830140|BG001|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
11142584|NCT01830140|BG002|Baseline|Total|Total of all reporting groups
11142585|NCT01830140|FG000|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
11142586|NCT01830140|FG001|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
11142587|NCT01830140|OG000|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
11142588|NCT01830140|OG001|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
11142589|NCT01830140|EG000|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
11142590|NCT01830140|EG001|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
11142591|NCT01830205|BG000|Baseline|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142592|NCT01830205|BG001|Baseline|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142593|NCT01830205|BG002|Baseline|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142594|NCT01830205|BG003|Baseline|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142595|NCT01830205|BG004|Baseline|Total|Total of all reporting groups
11142596|NCT01830205|FG000|Participant Flow|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had estimated glomerular filtration rate (eGFR) 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142597|NCT01830205|FG001|Participant Flow|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142598|NCT01830205|FG002|Participant Flow|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142599|NCT01830205|FG003|Participant Flow|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142600|NCT01830205|OG000|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142601|NCT01830205|OG001|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142602|NCT01830205|OG002|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142603|NCT01830205|OG003|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142604|NCT01830205|OG004|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) < 15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142605|NCT01830205|OG003|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
11142606|NCT01830205|OG004|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142607|NCT01830205|OG000|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
11142608|NCT01830205|OG002|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
11142609|NCT01830205|OG001|Outcome|Mild Renal Impairment|Participants were re-randomized from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
10879729|NCT00459368|OG001|Outcome|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
11142610|NCT01830205|OG000|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142611|NCT01830205|OG001|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142612|NCT01830205|OG002|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142613|NCT01830205|OG003|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142614|NCT01830205|OG001|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142615|NCT01830205|EG000|Reported Event|Group-A|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142616|NCT01830205|EG001|Reported Event|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11149808|NCT01873859|EG000|Reported Event|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
11149809|NCT01873859|EG001|Reported Event|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
11142617|NCT01830205|EG002|Reported Event|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
11142618|NCT01830205|EG003|Reported Event|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
11142619|NCT01830543|BG000|Baseline|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
11142620|NCT01830543|BG001|Baseline|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
11142621|NCT01830543|BG002|Baseline|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
11142622|NCT01830543|BG003|Baseline|Total|Total of all reporting groups
11142623|NCT01830543|FG000|Participant Flow|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
11142624|NCT01830543|FG001|Participant Flow|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
11142625|NCT01830543|FG002|Participant Flow|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
11142626|NCT01830543|OG000|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
11142627|NCT01830543|OG001|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
11142628|NCT01830543|OG002|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
11142629|NCT01830543|EG000|Reported Event|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
11149810|NCT01873950|BG000|Baseline|All Study Participants|Participants who were randomized to receive either ranolazine, dofetilide, verapamil, quinidine or placebo.
11142630|NCT01830543|EG001|Reported Event|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
11142631|NCT01830543|EG002|Reported Event|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
11142632|NCT01830595|BG000|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and active drug first.
11142633|NCT01830595|FG000|Participant Flow|Placebo First Then Lactoferrin|Participants receive placebo during first period, then Lactoferrin in second period after washout.
11142634|NCT01830595|FG001|Participant Flow|Lactoferrin First Then Placebo|Participants receive Lactoferrin during first period, then placebo in second period after washout.
11142635|NCT01830595|OG000|Outcome|Placebo|"Matched placebo will be administered by mouth twice daily~Placebo"
11142636|NCT01830595|OG001|Outcome|Recombinant Lactoferrin|"Recombinant lactoferrin will be administered by mouth twice daily~Recombinant Lactoferrin"
11142637|NCT01830595|EG000|Reported Event|Placebo|"Matched placebo will be administered by mouth twice daily~Placebo"
11142638|NCT01830595|EG001|Reported Event|Recombinant Lactoferrin|"Recombinant lactoferrin will be administered by mouth twice daily~Recombinant Lactoferrin"
11142639|NCT01830621|BG000|Baseline|BBI608|"BBI608 480 mg two times daily (960 mg total daily dose)+ Best Supportive Care~BBI608~Best Supportive Care"
11142640|NCT01830621|BG001|Baseline|Placebo|"Placebo two times daily + Best Supportive Care~Placebo~Best Supportive Care"
11142641|NCT01830621|BG002|Baseline|Total|Total of all reporting groups
11142642|NCT01830621|FG000|Participant Flow|BBI608|"BBI608 480 mg two times daily (960 mg total daily dose)+ Best Supportive Care~BBI608~Best Supportive Care"
11142643|NCT01830621|FG001|Participant Flow|Placebo|"Placebo two times daily + Best Supportive Care~Placebo~Best Supportive Care"
11142644|NCT01830621|OG000|Outcome|BBI608|"BBI608 480 mg two times daily (960 mg total daily dose)+ Best Supportive Care~BBI608~Best Supportive Care"
11142645|NCT01830621|OG001|Outcome|Placebo|"Placebo two times daily + Best Supportive Care~Placebo~Best Supportive Care"
11142646|NCT01830621|EG000|Reported Event|BBI608|"BBI608 480 mg two times daily (960 mg total daily dose)+ Best Supportive Care~BBI608~Best Supportive Care~At risk patients included only patients who received at least one dose of BBI608"
11142647|NCT01830621|EG001|Reported Event|Placebo|"Placebo two times daily + Best Supportive Care~Placebo~Best Supportive Care~At risk patients included only patients who received at least one dose of placebo"
11142648|NCT01830699|BG000|Baseline|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
11142649|NCT01830699|BG001|Baseline|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
11142650|NCT01830699|BG002|Baseline|Total|Total of all reporting groups
11142651|NCT01830699|FG000|Participant Flow|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
11142652|NCT01830699|FG001|Participant Flow|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
11142653|NCT01830699|OG000|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
11142654|NCT01830699|OG001|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
11142655|NCT01830699|EG000|Reported Event|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
11142656|NCT01830699|EG001|Reported Event|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
11142657|NCT01830816|BG000|Baseline|Normal Renal Function: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142658|NCT01830816|BG001|Baseline|Severe Renal Impairment: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142659|NCT01830816|BG002|Baseline|End-stage Renal Disease: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142660|NCT01830816|BG003|Baseline|Total|Total of all reporting groups
11142661|NCT01830816|FG000|Participant Flow|Normal Renal Function: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142662|NCT01830816|FG001|Participant Flow|Severe Renal Impairment: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142663|NCT01830816|FG002|Participant Flow|End-stage Renal Disease: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142664|NCT01830816|OG000|Outcome|Normal Renal Function: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142665|NCT01830816|OG001|Outcome|Severe Renal Impairment: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142666|NCT01830816|OG002|Outcome|End-stage Renal Disease: Ixazomib|Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
11142667|NCT01830816|OG000|Outcome|Normal Renal Function: Ixazomib|After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
11142668|NCT01830816|OG001|Outcome|Severe Renal Impairment: Ixazomib|After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
11142669|NCT01830816|OG002|Outcome|End-stage Renal Disease: Ixazomib|After part A the participant has the option to participate in Part B start with ixazomib capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
11142670|NCT01830816|EG000|Reported Event|Normal Renal Function: Ixazomib|"Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in normal renal function participants until disease progression or unacceptable toxicity in part B.~Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines."
11142671|NCT01830816|EG001|Reported Event|Severe Renal Impairment: Ixazomib|"Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in severe renal impairment participants until disease progression or unacceptable toxicity in part B.~Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines."
11142672|NCT01830816|EG002|Reported Event|End-stage Renal Disease: Ixazomib|"Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in end-stage renal disease participants until disease progression or unacceptable toxicity in part B.~Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines."
11142673|NCT01830842|BG000|Baseline|Nicotine, Placebo|"Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.~Nicotine polacrilex: nonsmokers will be measured following nicotine administration~Placebo: nonsmokers will be measured following placebo administration"
11142674|NCT01830842|BG001|Baseline|Nicotine Withdrawal or Satiety|"Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence~satiety: smokers will be measured in a smoking satiated condition~abstinence: smokers will be measured following 24-hours of smoking abstinence"
11142675|NCT01830842|BG002|Baseline|Total|Total of all reporting groups
11142676|NCT01830842|FG000|Participant Flow|Nicotine, Placebo|"Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.~Nicotine polacrilex: nonsmokers will be measured following nicotine administration~Placebo: nonsmokers will be measured following placebo administration"
11142677|NCT01830842|FG001|Participant Flow|Nicotine Withdrawal or Satiety|"Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence~satiety: smokers will be measured in a smoking satiated condition~abstinence: smokers will be measured following 24-hours of smoking abstinence"
11142678|NCT01830842|OG000|Outcome|Nonsmokers|"Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.~Nicotine polacrilex: nonsmokers will be measured following nicotine administration~Placebo: nonsmokers will be measured following placebo administration"
11142679|NCT01830842|OG001|Outcome|Smokers|"Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence~satiety: smokers will be measured in a smoking satiated condition~abstinence: smokers will be measured following 24-hours of smoking abstinence"
11142680|NCT01830842|EG000|Reported Event|Nicotine, Placebo|"Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.~Nicotine polacrilex: nonsmokers will be measured following nicotine administration~Placebo: nonsmokers will be measured following placebo administration"
11142681|NCT01830842|EG001|Reported Event|Nicotine Withdrawal or Satiety|"Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence~satiety: smokers will be measured in a smoking satiated condition~abstinence: smokers will be measured following 24-hours of smoking abstinence"
11142682|NCT01830855|BG000|Baseline|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
11142683|NCT01830855|BG001|Baseline|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
11142684|NCT01830855|BG002|Baseline|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
11142685|NCT01830855|BG003|Baseline|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
11142686|NCT01830855|BG004|Baseline|Total|Total of all reporting groups
11142687|NCT01830855|FG000|Participant Flow|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
11142688|NCT01830855|FG001|Participant Flow|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
11142689|NCT01830855|FG002|Participant Flow|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
11142690|NCT01830855|FG003|Participant Flow|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
11142691|NCT01830855|OG000|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
11142692|NCT01830855|OG001|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
11142693|NCT01830855|OG002|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
11142694|NCT01830855|OG000|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
11142695|NCT01830855|OG001|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
11142696|NCT01830855|OG000|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
11142697|NCT01830855|OG001|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
11142698|NCT01830855|OG001|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule.
11142699|NCT01830855|OG002|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule.
11142700|NCT01830855|EG000|Reported Event|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
11142701|NCT01830855|EG001|Reported Event|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
11142702|NCT01830855|EG002|Reported Event|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
11142703|NCT01830855|EG003|Reported Event|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
11142704|NCT01830881|BG000|Baseline|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142705|NCT01830881|BG001|Baseline|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142706|NCT01830881|BG002|Baseline|Total|Total of all reporting groups
11142707|NCT01830881|FG000|Participant Flow|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142708|NCT01830881|FG001|Participant Flow|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142709|NCT01830881|OG000|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142710|NCT01830881|OG001|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142711|NCT01830881|OG000|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142712|NCT01830881|OG001|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142713|NCT01830881|EG000|Reported Event|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142714|NCT01830881|EG001|Reported Event|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
11142715|NCT01830920|BG000|Baseline|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
11142716|NCT01830920|BG001|Baseline|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142717|NCT01830920|BG002|Baseline|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142718|NCT01830920|BG003|Baseline|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142719|NCT01830920|BG004|Baseline|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142720|NCT01830920|BG005|Baseline|Total|Total of all reporting groups
11142721|NCT01830920|FG000|Participant Flow|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
11142722|NCT01830920|FG001|Participant Flow|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142723|NCT01830920|FG002|Participant Flow|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142724|NCT01830920|FG003|Participant Flow|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142725|NCT01830920|FG004|Participant Flow|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142726|NCT01830920|OG000|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
11142727|NCT01830920|OG001|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142728|NCT01830920|OG002|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142729|NCT01830920|OG003|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142730|NCT01830920|OG004|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142731|NCT01830920|EG000|Reported Event|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
11142732|NCT01830920|EG001|Reported Event|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142733|NCT01830920|EG002|Reported Event|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142734|NCT01830920|EG003|Reported Event|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142735|NCT01830920|EG004|Reported Event|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
11142736|NCT01830933|BG000|Baseline|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
11142737|NCT01830933|BG001|Baseline|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
11142738|NCT01830933|BG002|Baseline|Total|Total of all reporting groups
11142739|NCT01830933|FG000|Participant Flow|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
11142740|NCT01830933|FG001|Participant Flow|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
11142741|NCT01830933|OG000|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
11142742|NCT01830933|OG001|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
11142743|NCT01830933|EG000|Reported Event|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
11142744|NCT01830933|EG001|Reported Event|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
11142745|NCT01830972|BG000|Baseline|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142746|NCT01830972|BG001|Baseline|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142747|NCT01830972|BG002|Baseline|Total|Total of all reporting groups
11149811|NCT01873950|FG000|Participant Flow|Ranolazine 1500 mg|Single oral dose of Ranolazine 1500mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
11142748|NCT01830972|FG000|Participant Flow|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142749|NCT01830972|FG001|Participant Flow|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142750|NCT01830972|OG000|Outcome|Crossover Participants; 6 g/Day|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142751|NCT01830972|OG001|Outcome|Crossover Participants: 12 g/Day|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142752|NCT01830972|OG002|Outcome|Crossover Participants: Any Dose|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142753|NCT01830972|OG003|Outcome|Naïve Participants: 6 g/Day|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142754|NCT01830972|OG004|Outcome|Naïve Participants: 12 g/Day|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142755|NCT01830972|OG005|Outcome|Overall: Any Dose|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study and treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142756|NCT01830972|OG000|Outcome|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142757|NCT01830972|OG001|Outcome|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142758|NCT01830972|EG000|Reported Event|Crossover Participants; 6 g/Day|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142759|NCT01830972|EG001|Reported Event|Crossover Participants: 12 g/Day|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142760|NCT01830972|EG002|Reported Event|Crossover Participants: Any Dose|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142761|NCT01830972|EG003|Reported Event|Naïve Participants: 6 g/Day|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142762|NCT01830972|EG004|Reported Event|Naïve Participants: 12 g/Day|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142763|NCT01830972|EG005|Reported Event|Overall: Any Dose|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study and treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
11142764|NCT01831089|BG000|Baseline|Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD]|"Cohort I~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142765|NCT01831089|BG001|Baseline|Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD]|"Cohort II~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142766|NCT01831089|BG002|Baseline|Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD|"Cohort III~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142767|NCT01831089|BG003|Baseline|Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD]|"Cohort IV~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142768|NCT01831089|BG004|Baseline|Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD]|"Cohort V~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142769|NCT01831089|BG005|Baseline|Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg|"All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows:~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour.~PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour.~Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142770|NCT01831089|BG006|Baseline|Total|Total of all reporting groups
11142771|NCT01831089|FG000|Participant Flow|Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD]|"Cohort I~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142772|NCT01831089|FG001|Participant Flow|Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD]|"Cohort II~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142773|NCT01831089|FG002|Participant Flow|Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD|"Cohort III~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142774|NCT01831089|FG003|Participant Flow|Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD]|"Cohort IV~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142775|NCT01831089|FG004|Participant Flow|Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD]|"Cohort V~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142776|NCT01831089|FG005|Participant Flow|Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg|"All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows:~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour.~PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour.~Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142777|NCT01831089|OG000|Outcome|Group A (Paclitaxel/PM01183)|All participants who received at least 1 dose of Paclitaxel/PM01183, either at 60/3.0, 60/4.0, 60/5.0, 80/5.0, 80/4.0 mg/m2 / mg FD.
11142778|NCT01831089|OG000|Outcome|Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD]|"Cohort I~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142779|NCT01831089|OG001|Outcome|Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD]|"Cohort II~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142780|NCT01831089|OG002|Outcome|Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD|"Cohort III~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142781|NCT01831089|OG003|Outcome|Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD]|"Cohort IV~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142782|NCT01831089|OG004|Outcome|Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD]|"Cohort V~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142783|NCT01831089|OG005|Outcome|Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg|"All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows:~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour.~PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour.~Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11149812|NCT01873950|FG001|Participant Flow|Dofetilide 500 mcg|Single oral dose of Dofetilide 500mcg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
10887439|NCT00500357|OG001|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
11142784|NCT01831089|EG000|Reported Event|Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD]|"Cohort I~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142785|NCT01831089|EG001|Reported Event|Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD]|"Cohort II~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142786|NCT01831089|EG002|Reported Event|Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD|"Cohort III~Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142787|NCT01831089|EG003|Reported Event|Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD]|"Cohort IV~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142788|NCT01831089|EG004|Reported Event|Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD]|"Cohort V~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter.~PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142789|NCT01831089|EG005|Reported Event|Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg|"All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows:~Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour.~PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour.~Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device.~Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement."
11142790|NCT01831154|BG000|Baseline|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
11149813|NCT01873950|FG002|Participant Flow|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
11149814|NCT01873950|FG003|Participant Flow|Quinidine Sulfate 400 mg|Single oral dose of Quinidine sulfate 400mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
11149815|NCT01873950|FG004|Participant Flow|Placebo|Single oral dose of Placebo (comparison group). Each subject received each drug only once in a randomized sequence (10 sequences in total).
10887286|NCT00499616|OG000|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11142791|NCT01831154|BG001|Baseline|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
11142792|NCT01831154|BG002|Baseline|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
11142793|NCT01831154|BG003|Baseline|Total|Total of all reporting groups
11142794|NCT01831154|FG000|Participant Flow|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
11142795|NCT01831154|FG001|Participant Flow|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
11142796|NCT01831154|FG002|Participant Flow|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
11142797|NCT01831154|OG000|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
11142798|NCT01831154|OG001|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
11149816|NCT01873950|OG000|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
11149817|NCT01873950|OG001|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
11149818|NCT01873950|OG002|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
11149819|NCT01873950|OG003|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
11149820|NCT01873950|OG000|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
11149821|NCT01873950|OG001|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
10850951|NCT03410992|OG003|Outcome|Bimekizumab 320 mg Q4W/Q8W+Q4W/Q4W (WK16ResS)|This arm consists of participants who were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period and those who were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
11142799|NCT01831154|OG002|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
11142800|NCT01831154|EG000|Reported Event|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
11142801|NCT01831154|EG001|Reported Event|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
11142802|NCT01831154|EG002|Reported Event|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
11142803|NCT01831219|BG000|Baseline|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
11142804|NCT01831219|BG001|Baseline|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
11142805|NCT01831219|BG002|Baseline|Total|Total of all reporting groups
11142806|NCT01831219|FG000|Participant Flow|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
11142807|NCT01831219|FG001|Participant Flow|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
11142808|NCT01831219|OG000|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
11142809|NCT01831219|OG001|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
11142810|NCT01831219|EG000|Reported Event|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical sys...
11142811|NCT01831219|EG001|Reported Event|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
11142812|NCT01831232|BG000|Baseline|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11142813|NCT01831232|FG000|Participant Flow|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11142814|NCT01831232|OG000|Outcome|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11142815|NCT01831232|EG000|Reported Event|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11142816|NCT01831258|BG000|Baseline|All Study Participants|Participants who were randomized to receive either SensAwake On or SensAwake Off
11142817|NCT01831258|FG000|Participant Flow|SensAwake On, Then Followed by SensAwake Off|The comfort feature 'SensAwake' will be turned on, followed by it off.
11142818|NCT01831258|FG001|Participant Flow|SensAwake Off, Then Followed by SensAwake On|The comfort feature 'SensAwake' will be turned off, then followed by on.
11142819|NCT01831258|OG000|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
11142820|NCT01831258|OG001|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
11142821|NCT01831258|OG000|Outcome|SensAwake On|"The comfort feature 'SensAwake' will be turned on~SensAwake On"
11142822|NCT01831258|OG001|Outcome|SensAwake Off|"The comfort feature 'SensAwake' will be turned off~SensAwake Off"
11142823|NCT01831258|EG000|Reported Event|SensAwake On|The comfort feature 'SensAwake' will be turned on
11142824|NCT01831258|EG001|Reported Event|SensAwake Off|The comfort feature 'SensAwake' will be turned off
11142825|NCT01831427|BG000|Baseline|Andecaliximab 0.3 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.
11142826|NCT01831427|BG001|Baseline|Andecaliximab 1.0 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.
11142827|NCT01831427|BG002|Baseline|Andecaliximab 2.5 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.
11142828|NCT01831427|BG003|Baseline|Andecaliximab 5.0 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.
11142829|NCT01831427|BG004|Baseline|Placebo Pooled (SAD)|Participants received a single IV infusion of placebo on Day 1.
11142830|NCT01831427|BG005|Baseline|Andecaliximab 0.3 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.
11142831|NCT01831427|BG006|Baseline|Andecaliximab 1.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.
11142832|NCT01831427|BG007|Baseline|Andecaliximab 2.5 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.
11349041|NCT04128293|FG002|Participant Flow|Sequence 3 - Treatment CDAB|Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
11142833|NCT01831427|BG008|Baseline|Andecaliximab 5.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.
11142834|NCT01831427|BG009|Baseline|Andecaliximab 150 mg SC (Adaptive MAD)|Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.
11142835|NCT01831427|BG010|Baseline|Placebo Pooled (MAD)|Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
11142836|NCT01831427|BG011|Baseline|Total|Total of all reporting groups
11142837|NCT01831427|FG000|Participant Flow|Andecaliximab 0.3 mg/kg IV Single Ascending Dose (SAD)|Participants received a single intravenous (IV) infusion of andecaliximab 0.3 milligrams per kilogram (mg/kg) on Day 1.
11142838|NCT01831427|FG001|Participant Flow|Andecaliximab 1.0 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.
11142839|NCT01831427|FG002|Participant Flow|Andecaliximab 2.5 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.
11142840|NCT01831427|FG003|Participant Flow|Andecaliximab 5.0 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.
11142841|NCT01831427|FG004|Participant Flow|Placebo Pooled (SAD)|Participants received a single IV infusion of placebo on Day 1.
11142842|NCT01831427|FG005|Participant Flow|Andecaliximab 0.3 mg/kg IV Multiple Ascending Doses (MAD)|Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.
11142843|NCT01831427|FG006|Participant Flow|Andecaliximab 1.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.
11142844|NCT01831427|FG007|Participant Flow|Andecaliximab 2.5 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.
11142845|NCT01831427|FG008|Participant Flow|Andecaliximab 5.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.
11142846|NCT01831427|FG009|Participant Flow|Andecaliximab 150 mg SC (Adaptive MAD)|Participants received 5 single subcutaneous (SC) doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.
11142847|NCT01831427|FG010|Participant Flow|Placebo Pooled (MAD)|Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
11142848|NCT01831427|OG000|Outcome|Andecaliximab 0.3 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.
11142849|NCT01831427|OG001|Outcome|Andecaliximab 1.0 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.
11142850|NCT01831427|OG002|Outcome|Andecaliximab 2.5 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.
11142851|NCT01831427|OG003|Outcome|Andecaliximab 5.0 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.
11142852|NCT01831427|OG004|Outcome|Andecaliximab IV Combined (SAD)|Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.
11142853|NCT01831427|OG005|Outcome|Placebo Pooled (SAD)|Participants received a single IV infusion of placebo on Day 1.
11142854|NCT01831427|OG006|Outcome|Andecaliximab 0.3 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.
11142855|NCT01831427|OG007|Outcome|Andecaliximab 1.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.
11142856|NCT01831427|OG008|Outcome|Andecaliximab 2.5 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.
11142857|NCT01831427|OG009|Outcome|Andecaliximab 5.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.
11149822|NCT01873950|OG001|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
11142858|NCT01831427|OG010|Outcome|Andecaliximab IV Combined (MAD)|Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.
11142859|NCT01831427|OG011|Outcome|Andecaliximab 150 mg SC (Adaptive MAD)|Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.
11142860|NCT01831427|OG012|Outcome|Andecaliximab IV+SC Combined (MAD)|Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.
11142861|NCT01831427|OG013|Outcome|Placebo Pooled (MAD)|Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
11142862|NCT01831427|OG000|Outcome|Andecaliximab 0.3 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.
11142863|NCT01831427|OG001|Outcome|Andecaliximab 1.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.
11142864|NCT01831427|OG002|Outcome|Andecaliximab 2.5 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.
11142865|NCT01831427|OG003|Outcome|Andecaliximab 5.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.
11142866|NCT01831427|OG004|Outcome|Andecaliximab 150 mg SC (Adaptive MAD)|Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.
11142867|NCT01831427|EG000|Reported Event|Andecaliximab 0.3 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.
11142868|NCT01831427|EG001|Reported Event|Andecaliximab 1.0 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.
11142869|NCT01831427|EG002|Reported Event|Andecaliximab 2.5 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.
11142870|NCT01831427|EG003|Reported Event|Andecaliximab 5.0 mg/kg IV (SAD)|Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.
11142871|NCT01831427|EG004|Reported Event|Andecaliximab IV Combined (SAD)|Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.
11142872|NCT01831427|EG005|Reported Event|Placebo Pooled (SAD)|Participants received a single IV infusion of placebo on Day 1.
11142873|NCT01831427|EG006|Reported Event|Andecaliximab 0.3 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.
11142874|NCT01831427|EG007|Reported Event|Andecaliximab 1.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.
11142875|NCT01831427|EG008|Reported Event|Andecaliximab 2.5 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.
11142876|NCT01831427|EG009|Reported Event|Andecaliximab 5.0 mg/kg IV (MAD)|Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.
11142877|NCT01831427|EG010|Reported Event|Andecaliximab IV Combined (MAD)|Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.
11142878|NCT01831427|EG011|Reported Event|Andecaliximab 150 mg SC (Adaptive MAD)|Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.
11142879|NCT01831427|EG012|Reported Event|Andecaliximab IV+SC Combined (MAD)|Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.
11142880|NCT01831427|EG013|Reported Event|Placebo Pooled (MAD)|Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
11142881|NCT01831466|BG000|Baseline|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
11142882|NCT01831466|BG001|Baseline|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
11142883|NCT01831466|BG002|Baseline|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
11142884|NCT01831466|BG003|Baseline|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
11142885|NCT01831466|BG004|Baseline|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
11142886|NCT01831466|BG005|Baseline|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
11142887|NCT01831466|BG006|Baseline|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
11142888|NCT01831466|BG007|Baseline|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
11142889|NCT01831466|BG008|Baseline|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
11142890|NCT01831466|BG009|Baseline|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
11142891|NCT01831466|BG010|Baseline|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
11142892|NCT01831466|BG011|Baseline|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
11142893|NCT01831466|BG012|Baseline|Total|Total of all reporting groups
11142894|NCT01831466|FG000|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)|Participants with a baseline Calculated Physician's Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
11142895|NCT01831466|FG001|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
11142896|NCT01831466|FG002|Participant Flow|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
11142897|NCT01831466|FG003|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
11142898|NCT01831466|FG004|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
11142899|NCT01831466|FG005|Participant Flow|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
11142900|NCT01831466|FG006|Participant Flow|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
11142901|NCT01831466|FG007|Participant Flow|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
11142902|NCT01831466|FG008|Participant Flow|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
11142903|NCT01831466|FG009|Participant Flow|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
11142904|NCT01831466|FG010|Participant Flow|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
11142905|NCT01831466|FG011|Participant Flow|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
11142906|NCT01831466|OG000|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
11142907|NCT01831466|OG001|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
11142908|NCT01831466|OG002|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
11142909|NCT01831466|OG003|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
11142910|NCT01831466|OG004|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
11142911|NCT01831466|OG005|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
11142912|NCT01831466|EG000|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
11142913|NCT01831466|EG001|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
11142914|NCT01831466|EG002|Reported Event|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
11142915|NCT01831466|EG003|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
11142916|NCT01831466|EG004|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
11142917|NCT01831466|EG005|Reported Event|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
11142918|NCT01831466|EG006|Reported Event|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
11142919|NCT01831466|EG007|Reported Event|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
11142920|NCT01831466|EG008|Reported Event|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
11142921|NCT01831466|EG009|Reported Event|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
11142922|NCT01831466|EG010|Reported Event|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
11142923|NCT01831466|EG011|Reported Event|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
11142924|NCT01831544|BG000|Baseline|MVAD® Pump|"Implant of HeartWare MVAD® System~HeartWare MVAD® System: The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system"
11142925|NCT01831544|FG000|Participant Flow|MVAD® Pump|"Implant of HeartWare MVAD® System~HeartWare MVAD® System: The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system"
11142926|NCT01831544|OG000|Outcome|MVAD® Pump|"Implant of HeartWare MVAD® System~HeartWare MVAD® System: The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system"
11142927|NCT01831544|EG000|Reported Event|MVAD® Pump|"Implant of HeartWare MVAD® System~HeartWare MVAD® System: The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system"
11142928|NCT01831726|BG000|Baseline|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
11149823|NCT01873950|EG000|Reported Event|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
11142929|NCT01831726|FG000|Participant Flow|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
11142930|NCT01831726|OG000|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
11142931|NCT01831726|EG000|Reported Event|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
11142932|NCT01831765|BG000|Baseline|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142933|NCT01831765|BG001|Baseline|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142934|NCT01831765|BG002|Baseline|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142935|NCT01831765|BG003|Baseline|Total|Total of all reporting groups
11142936|NCT01831765|FG000|Participant Flow|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142937|NCT01831765|FG001|Participant Flow|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142938|NCT01831765|FG002|Participant Flow|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142939|NCT01831765|OG000|Outcome|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11149824|NCT01873950|EG001|Reported Event|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
11149825|NCT01873950|EG002|Reported Event|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
11149826|NCT01873950|EG003|Reported Event|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
11149827|NCT01873950|EG004|Reported Event|Placebo|Single oral dose of Placebo (comparison group)
11142940|NCT01831765|OG001|Outcome|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142941|NCT01831765|OG002|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142942|NCT01831765|OG000|Outcome|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142943|NCT01831765|OG001|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142944|NCT01831765|EG000|Reported Event|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142945|NCT01831765|EG001|Reported Event|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142946|NCT01831765|EG002|Reported Event|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0-2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator's recommendation.
11142947|NCT01831791|BG000|Baseline|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
10887440|NCT00500357|OG001|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
11142948|NCT01831791|FG000|Participant Flow|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
11142949|NCT01831791|OG000|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
11142950|NCT01831791|EG000|Reported Event|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
11142951|NCT01831804|BG000|Baseline|Placebo HVT (Cohort 1)|Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods.
11149828|NCT01873989|BG000|Baseline|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
11142952|NCT01831804|BG001|Baseline|Placebo DFU SD (Cohort 2, 3, 4)|Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods.
11142953|NCT01831804|BG002|Baseline|A/B (Cohort 1)|Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods.
11142954|NCT01831804|BG003|Baseline|C/C (Cohort 2)|Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2.
11142955|NCT01831804|BG004|Baseline|D (Cohort 3)|Participants with DFU were administered a single dose of 1 percent of 25 mg/cm^2 GSK1278863 on wounded skin.
11142956|NCT01831804|BG005|Baseline|E/E (Cohort 4)|A single dose of 1 percent of 100 mg/cm^2 GSK1278863 was applied directly to wounded skin in Period 1, followed by application of a single dose of 1 percent of 100 mg/cm^2 GSK1278863 to intact skin. There was a wash-out period of at least 10 days between the two dosing periods.
11142957|NCT01831804|BG006|Baseline|Placebo DFU RD (Cohort 5)|Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy.
11142958|NCT01831804|BG007|Baseline|R1r (Cohort 5)|Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment.
11142959|NCT01831804|BG008|Baseline|Sr (Cohort 5)|Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days.
11142960|NCT01831804|BG009|Baseline|Total|Total of all reporting groups
11142961|NCT01831804|FG000|Participant Flow|Placebo HVT (Cohort 1)|Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods.
11142962|NCT01831804|FG001|Participant Flow|Placebo DFU SD (Cohort 2, 3, 4)|Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods.
11142963|NCT01831804|FG002|Participant Flow|A/B (Cohort 1)|Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods.
11142964|NCT01831804|FG003|Participant Flow|C/C (Cohort 2)|Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2.
11142965|NCT01831804|FG004|Participant Flow|D (Cohort 3)|Participants with DFU were administered a single dose of 1 percent of 25 mg/cm^2 GSK1278863 on wounded skin.
11142966|NCT01831804|FG005|Participant Flow|E/E (Cohort 4)|A single dose of 1 percent of 100 mg/cm^2 GSK1278863 was applied directly to wounded skin in Period 1, followed by application of a single dose of 1 percent of 100 mg/cm^2 GSK1278863 to intact skin. There was a wash-out period of at least 10 days between the two dosing periods.
11142967|NCT01831804|FG006|Participant Flow|Placebo DFU RD (Cohort 5)|Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy.
11142968|NCT01831804|FG007|Participant Flow|R1r (Cohort 5)|Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment.
11142969|NCT01831804|FG008|Participant Flow|Sr (Cohort 5)|Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days.
11142970|NCT01831804|OG000|Outcome|Placebo HVT (Cohort 1)|Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods.
11142971|NCT01831804|OG001|Outcome|A/B (Cohort 1)|Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods.
11142972|NCT01831804|OG002|Outcome|Placebo DFU SD (Cohort 2, 3, 4)|Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods.
11142973|NCT01831804|OG003|Outcome|C (Cohort 2)|Participants with DFU were a single dose of 0.1 percent of 25 mg/cm^2 GSK1278863 on wounded skin.
11142974|NCT01831804|OG004|Outcome|D (Cohort 3)|Participants with DFU were administered a single dose of 1 percent of 25 mg/cm^2 GSK1278863 on wounded skin.
11142975|NCT01831804|OG005|Outcome|E (Cohort 4)|Participants with DFU were administered a single dose of 1 percent of 100 mg/cm^2 GSK1278863 on wounded skin.
11142976|NCT01831804|OG000|Outcome|Placebo DFU RD (Cohort 5)|Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy.
11142977|NCT01831804|OG001|Outcome|R1r (Cohort 5)|Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment.
11142978|NCT01831804|OG002|Outcome|Sr (Cohort 5)|Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days.
11142979|NCT01831804|OG001|Outcome|Placebo DFU SD (Cohort 2, 3, 4)|Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods.
11149829|NCT01873989|BG001|Baseline|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
11149830|NCT01873989|BG002|Baseline|Total|Total of all reporting groups
11142980|NCT01831804|OG002|Outcome|A/B (Cohort 1)|Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods.
11142981|NCT01831804|OG003|Outcome|C/C (Cohort 2)|Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2.
11142982|NCT01831804|OG005|Outcome|E/E (Cohort 4)|A single dose of 1 percent of 100 mg/cm^2 GSK1278863 was applied directly to wounded skin in Period 1, followed by application of a single dose of 1 percent of 100 mg/cm^2 GSK1278863 to intact skin. There was a wash-out period of at least 10 days between the two dosing periods.
11142983|NCT01831804|OG000|Outcome|A/B (Cohort 1)|Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods.
11142984|NCT01831804|OG001|Outcome|C/C (Cohort 2)|Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2.
11142985|NCT01831804|OG002|Outcome|D (Cohort 3)|Participants with DFU were administered a single dose of 1 percent of 25 mg/cm^2 GSK1278863 on wounded skin.
11142986|NCT01831804|OG003|Outcome|E/E (Cohort 4)|A single dose of 1 percent of 100 mg/cm^2 GSK1278863 was applied directly to wounded skin in Period 1, followed by application of a single dose of 1 percent of 100 mg/cm^2 GSK1278863 to intact skin. There was a wash-out period of at least 10 days between the two dosing periods.
11142987|NCT01831804|OG000|Outcome|R1r (Cohort 5)|Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment.
11142988|NCT01831804|EG000|Reported Event|Placebo HVT (Cohort 1)|Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods.
11142989|NCT01831804|EG001|Reported Event|A/B (Cohort 1)|Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods.
11142990|NCT01831804|EG002|Reported Event|Placebo DFU SD (Cohort 2, 3, 4)|Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods.
11142991|NCT01831804|EG003|Reported Event|C (Cohort 2)|Participants with DFU were a single dose of 0.1 percent of 25 mg/cm^2 GSK1278863 on wounded skin.
11142992|NCT01831804|EG004|Reported Event|D (Cohort 3)|Participants with DFU were administered a single dose of 1 percent of 25 mg/cm^2 GSK1278863 on wounded skin.
11142993|NCT01831804|EG005|Reported Event|E (Cohort 4)|Participants with DFU were administered a single dose of 1 percent of 100 mg/cm^2 GSK1278863 on wounded skin.
11142994|NCT01831804|EG006|Reported Event|Placebo DFU RD (Cohort 5)|Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy.
11142995|NCT01831804|EG007|Reported Event|R1r (Cohort 5)|Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment.
11142996|NCT01831804|EG008|Reported Event|Sr (Cohort 5)|Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days.
11142997|NCT01831817|BG000|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
11142998|NCT01831817|BG001|Baseline|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
11142999|NCT01831817|BG002|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
11143000|NCT01831817|BG003|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
11143001|NCT01831817|BG004|Baseline|Total|Total of all reporting groups
11143002|NCT01831817|FG000|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
11143003|NCT01831817|FG001|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
11143004|NCT01831817|FG002|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
11143005|NCT01831817|FG003|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
11143006|NCT01831817|OG000|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
11143007|NCT01831817|OG001|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
11143008|NCT01831817|OG002|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
11143009|NCT01831817|OG003|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
11143010|NCT01831817|EG000|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|DDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
11143011|NCT01831817|EG001|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
11143012|NCT01831817|EG002|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
11143013|NCT01831817|EG003|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
11143014|NCT01831856|BG000|Baseline|F373280|"68 patients were randomised in the F373280 arm but one patient did not receive any dose of study treatment. 67 patients were also included in the analyses.~1g of F373280: Oral administration, one capsule each evening with dinner."
11143015|NCT01831856|BG001|Baseline|Placebo|67 patients were randomised in the placebo arm. Placebo: Oral administration, one capsule each evening with dinner.
11143016|NCT01831856|BG002|Baseline|Total|Total of all reporting groups
11143017|NCT01831856|FG000|Participant Flow|F373280|1g of F373280: Oral administration, one capsule each evening with dinner.
11143018|NCT01831856|FG001|Participant Flow|Placebo|Placebo: Oral administration, one capsule each evening with dinner.
11143019|NCT01831856|OG000|Outcome|F373280|"68 patients were randomised in the F373280 arm but one patient did not receive any dose of study treatment. 67 patients were also included in the analyses.~1g of F373280: Oral administration, one capsule each evening with dinner."
11143020|NCT01831856|OG001|Outcome|Placebo|67 patients were randomised in the placebo arm. Placebo: Oral administration, one capsule each evening with dinner.
11143021|NCT01831856|EG000|Reported Event|F373280|"68 patients were randomised in the F373280 arm but one patient did not receive any dose of study treatment. 67 patients were also included in the analyses.~1g of F373280: Oral administration, one capsule each evening with dinner."
11143022|NCT01831856|EG001|Reported Event|Placebo|67 patients were randomised in the placebo arm. Placebo: Oral administration, one capsule each evening with dinner.
11143023|NCT01831921|BG000|Baseline|Lifestyle Weight-Loss|"Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by Latino Health Advisors (LHAs). The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.~Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss."
11143024|NCT01831921|BG001|Baseline|Enhanced Usual Care|"Participants in the Behavioral: Counseling arm will receive two individual sessions with registered dietitian and monthly newsletters that focus on existing community resources.~Counseling: Individual nutrition counseling will be delivered by a registered dietitian."
11143025|NCT01831921|BG002|Baseline|Total|Total of all reporting groups
11143026|NCT01831921|FG000|Participant Flow|Lifestyle Weight-Loss|"Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by Latino Health Advisors (LHAs). The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.~Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss."
11143027|NCT01831921|FG001|Participant Flow|Enhanced Usual Care|"Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.~Counseling: Individual nutrition counseling will be delivered by a registered dietitian."
11143028|NCT01831921|OG000|Outcome|Lifestyle Weight-Loss|"Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1.~Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss."
11143029|NCT01831921|OG001|Outcome|Enhanced Usual Care|"Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.~Counseling: Individual nutrition counseling will be delivered by a registered dietitian."
11143030|NCT01831921|OG000|Outcome|Lifestyle Weight-Loss|"Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with an RD during months 1, 3, and 6 of phase 1.~Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss."
11143031|NCT01831921|OG001|Outcome|Enhanced Usual Care|"Participants in the Behavioral: Counseling arm will receive two individual sessions with an RD and monthly newsletters that focus on existing community resources.~Counseling: Individual nutrition counseling will be delivered by a registered dietitian."
11143032|NCT01831921|OG001|Outcome|Enhanced Usual Care|"Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.All participants will be seen for assessment visits as baseline, 6, and 12 months. Some participants will also complete 18 and 24 month visits, depending on the date of randomization.~Counseling: Individual nutrition counseling will be delivered by a registered dietitian."
11149831|NCT01873989|FG000|Participant Flow|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
11143033|NCT01831921|EG000|Reported Event|Lifestyle Weight-Loss|"Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with an RD during months 1, 3, and 6 of phase 1.~Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss."
11143034|NCT01831921|EG001|Reported Event|Enhanced Usual Care|"Participants in the Behavioral: Counseling arm will receive two individual sessions with an RD and monthly newsletters that focus on existing community resources.~Counseling: Individual nutrition counseling will be delivered by a registered dietitian."
11143035|NCT01831934|BG000|Baseline|MELAS Group|"Fluzone®~Fluzone®"
11143036|NCT01831934|BG001|Baseline|Control Group|"Fluzone®~Fluzone®"
11143037|NCT01831934|BG002|Baseline|Total|Total of all reporting groups
11143038|NCT01831934|FG000|Participant Flow|MELAS Group:13-60 Years of Age.|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses."
11143039|NCT01831934|FG001|Participant Flow|Control Group: 18-65 Years of Age|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses."
11143040|NCT01831934|OG000|Outcome|MELAS Group|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly"
11143041|NCT01831934|OG001|Outcome|Control Group|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly"
11143042|NCT01831934|EG000|Reported Event|MELAS Group|"Fluzone®~Fluzone®"
11143043|NCT01831934|EG001|Reported Event|Control Group|"Fluzone®~Fluzone®"
11143044|NCT01831960|BG000|Baseline|Cortexolone 17α-Propionate (Cohort 1)|Topical cream, 1.0% concentration, applied every twelve hours.
11143045|NCT01831960|BG001|Baseline|Cortexolone 17α-Propionate (Cohort 2)|Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
11143046|NCT01831960|BG002|Baseline|Total|Total of all reporting groups
11143047|NCT01831960|FG000|Participant Flow|Cortexolone 17α-Propionate (Cohort 1)|Cohort 1 enrolled adult subjects. Topical cream, 1.0% concentration, applied every twelve hours.
11143048|NCT01831960|FG001|Participant Flow|Cortexolone 17α-Propionate (Cohort 2)|Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
11143049|NCT01831960|OG000|Outcome|Cortexolone 17α-Propionate (Cohort 1)|Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.
11143050|NCT01831960|OG001|Outcome|Cortexolone 17α-Propionate (Cohort 2)|Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
11143051|NCT01831960|OG000|Outcome|Cortexolone 17α-Propionate (Cohort 1)|Topical cream, 1.0% concentration, applied every twelve hours.
11143052|NCT01831960|EG000|Reported Event|Cortexolone 17α-Propionate (Cohort 1)|Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.
11143053|NCT01831960|EG001|Reported Event|Cortexolone 17α-Propionate (Cohort 2)|Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
11143054|NCT01832038|BG000|Baseline|Lacosamide|At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day lacosamide (LCM). The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion.
11143055|NCT01832038|FG000|Participant Flow|Lacosamide|At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day lacosamide (LCM). The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion.
11143056|NCT01832038|OG000|Outcome|Lacosamide (SS)|At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Safety Set (SS).
11143057|NCT01832038|OG000|Outcome|Lacosamide (FAS)|At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Full Analysis Set (FAS).
11143058|NCT01832038|EG000|Reported Event|Lacosamide (SS)|At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Safety Set (SS).
11143059|NCT01832090|BG000|Baseline|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
11143060|NCT01832090|BG001|Baseline|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
11143061|NCT01832090|BG002|Baseline|Total|Total of all reporting groups
11143062|NCT01832090|FG000|Participant Flow|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
11143063|NCT01832090|FG001|Participant Flow|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
11143064|NCT01832090|OG000|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143065|NCT01832090|OG001|Outcome|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143066|NCT01832090|OG000|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
11143067|NCT01832090|OG001|Outcome|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
11143068|NCT01832090|OG000|Outcome|Age < 60 and Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143069|NCT01832090|OG001|Outcome|Age < 60 and Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143070|NCT01832090|OG002|Outcome|Age ≥ 60 and Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
10879730|NCT00459368|EG000|Reported Event|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
11143071|NCT01832090|OG003|Outcome|Age ≥ 60 and Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143072|NCT01832090|OG000|Outcome|Baseline: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143073|NCT01832090|OG001|Outcome|3 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143074|NCT01832090|OG002|Outcome|6 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143075|NCT01832090|OG003|Outcome|9 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143076|NCT01832090|OG004|Outcome|12 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143077|NCT01832090|OG003|Outcome|3 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143078|NCT01832090|OG004|Outcome|6 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143079|NCT01832090|OG000|Outcome|3 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143080|NCT01832090|OG001|Outcome|6 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143081|NCT01832090|OG002|Outcome|9 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143082|NCT01832090|OG003|Outcome|12 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143083|NCT01832090|OG000|Outcome|3 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143084|NCT01832090|OG001|Outcome|6 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11149832|NCT01873989|FG001|Participant Flow|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
11149833|NCT01873989|OG000|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
11143085|NCT01832090|OG004|Outcome|3 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143086|NCT01832090|OG005|Outcome|6 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
11143087|NCT01832090|EG000|Reported Event|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
11143088|NCT01832155|BG000|Baseline|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
11143089|NCT01832155|BG001|Baseline|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143090|NCT01832155|BG002|Baseline|Total|Total of all reporting groups
11143091|NCT01832155|FG000|Participant Flow|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
11143092|NCT01832155|FG001|Participant Flow|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143093|NCT01832155|OG000|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
11143094|NCT01832155|OG001|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143095|NCT01832155|OG000|Outcome|Class Rentention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143096|NCT01832155|OG000|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143097|NCT01832155|OG000|Outcome|About the Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143098|NCT01832155|OG000|Outcome|Both Groups During Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143099|NCT01832155|OG000|Outcome|Wait-list Control Group|Participants in the control group received the same Hatha yoga program at the end of 8 weeks when the intervention group completed their intervention classes.
11143100|NCT01832155|OG001|Outcome|Yoga Intervention Group|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143101|NCT01832155|EG000|Reported Event|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
11143102|NCT01832155|EG001|Reported Event|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
11143103|NCT01832259|BG000|Baseline|Placebo Arm|"Participants receiving placebo~Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy."
11143104|NCT01832259|BG001|Baseline|Pazopanib Arm|"Participants receiving Pazopanib~Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy."
11143105|NCT01832259|BG002|Baseline|Total|Total of all reporting groups
11143106|NCT01832259|FG000|Participant Flow|Placebo Arm|"Participants receiving placebo~Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy."
11143107|NCT01832259|FG001|Participant Flow|Pazopanib Arm|"Participants receiving Pazopanib~Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy."
11143108|NCT01832259|OG000|Outcome|Placebo Arm|"Participants receiving placebo~Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy."
11143109|NCT01832259|OG001|Outcome|Pazopanib Arm|"Participants receiving Pazopanib~Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy."
11143110|NCT01832259|EG000|Reported Event|Placebo Arm|"Participants receiving placebo~Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy."
11143111|NCT01832259|EG001|Reported Event|Pazopanib Arm|"Participants receiving Pazopanib~Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy."
11143112|NCT01832402|BG000|Baseline|Intervention Group (Fentanyl Pectin Nasal Spray)|Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.
11143113|NCT01832402|BG001|Baseline|Controlled Group (Placebo)|Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
11143114|NCT01832402|BG002|Baseline|Total|Total of all reporting groups
10879731|NCT00459368|EG001|Reported Event|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
11143115|NCT01832402|FG000|Participant Flow|Intervention Group (Fentanyl Pectin Nasal Spray)|Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.
11143116|NCT01832402|FG001|Participant Flow|Controlled Group (Placebo)|Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
11143117|NCT01832402|OG000|Outcome|Intervention Group (Fentanyl Pectin Nasal Spray)|Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.
11143118|NCT01832402|OG001|Outcome|Controlled Group (Placebo)|Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
11143119|NCT01832402|OG000|Outcome|Interventional Group (Fentanyl Pectin Nasal Spray)|Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.
11143120|NCT01832402|OG001|Outcome|Control Group (Placebo)|Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
11143121|NCT01832402|EG000|Reported Event|Interventional (Fentanyl Pectin Nasal Spray) Second Walk Test|Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.
11143122|NCT01832402|EG001|Reported Event|Control (Placebo), Second Walk Test|Received similar number of Placebo Spray 20 minutes before 2nd 6 minute walk tests.
11143123|NCT01832402|EG002|Reported Event|Interventional (Fentanyl Pectin Nasal Spray),Third Walk Test|Received Fentanyl Pectin Nasal Spray 20 minutes before 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.
11143124|NCT01832402|EG003|Reported Event|Control (Placebo), Third Walk Test|Received similar Placebo Spray 20 minutes before 3rd 6 minute walk tests.
11143125|NCT01832480|BG000|Baseline|Metronidazole (MTZ) 2 g|"Single dose MTZ~MTZ 2 g: MTZ 2 g"
11143126|NCT01832480|BG001|Baseline|Metronidazole (MTZ) 500 mg BID x 7 Days|"Multi dose MTZ~MTZ 500 mg BID x 7 days: MTZ 500 mg BID x 7days"
11143127|NCT01832480|BG002|Baseline|Total|Total of all reporting groups
11143128|NCT01832480|FG000|Participant Flow|Metronidazole (MTZ) 2 g|"Single dose MTZ~MTZ 2 g: MTZ 2 g"
11143129|NCT01832480|FG001|Participant Flow|Metronidazole (MTZ) 500 mg Twice Daily x 7 Days|"Multi dose MTZ~MTZ 500 mg twice daily x 7 days"
11143130|NCT01832480|OG000|Outcome|Trichomonas (TV) Positive After 2 g Dose|Subjects who were randomized to MTZ singe dose (2g) and tested TV positive at test of cure
11143131|NCT01832480|OG001|Outcome|Trichomonas (TV) Positive After Metronidazole (MTZ) Multi Dose|Subjects who were randomized to MTZ multi dose (500mg twice daily x 7 days) and tested TV positive at test of cure
11143132|NCT01832480|EG000|Reported Event|Metronidazole (MTZ) 2 g|This is the control dose arm.
11143133|NCT01832480|EG001|Reported Event|Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose|This is the experimental dose arm.
11143134|NCT01832493|BG000|Baseline|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
11143135|NCT01832493|FG000|Participant Flow|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
11143136|NCT01832493|OG000|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
11143137|NCT01832493|EG000|Reported Event|All Enrolled Patients|Adverse events were collected and are reported for all 50 enrolled patients
11143138|NCT01832506|BG000|Baseline|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143139|NCT01832506|BG001|Baseline|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143140|NCT01832506|BG002|Baseline|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143141|NCT01832506|BG003|Baseline|Total|Total of all reporting groups
11143142|NCT01832506|FG000|Participant Flow|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 milligram (mg) orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143143|NCT01832506|FG001|Participant Flow|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11009413|NCT01101867|FG001|Participant Flow|Fixed Dose|Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
11009414|NCT01101867|OG000|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
11009415|NCT01101867|OG001|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
11009416|NCT01101867|OG000|Outcome|Aspart Flexible Dose|"aspart dose determined based upon carbohydrate intake.~Aspart flexible dose: dose based upon carbohydrate intake and total daily requirements"
11009417|NCT01101867|OG001|Outcome|Aspart Fixed Dose|"fixed meal dose of aspart (based upon weight or total daily insulin dose)~Aspart fixed dose: fixed dose"
11009418|NCT01101867|OG000|Outcome|Flexible Dose|Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
11009419|NCT01101867|OG001|Outcome|Fixed Dose|Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
11009420|NCT01101867|EG000|Reported Event|Flexible Dose|aspart dose determined based upon carbohydrate intake.
11009421|NCT01101867|EG001|Reported Event|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
11009422|NCT01101880|BG000|Baseline|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
11009423|NCT01101880|FG000|Participant Flow|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
11009424|NCT01101880|OG000|Outcome|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
11009425|NCT01101880|EG000|Reported Event|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
11009426|NCT01101958|BG000|Baseline|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
11009427|NCT01101958|BG001|Baseline|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
11009428|NCT01101958|BG002|Baseline|Total|Total of all reporting groups
11009429|NCT01101958|FG000|Participant Flow|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
11009430|NCT01101958|FG001|Participant Flow|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
11009431|NCT01101958|OG000|Outcome|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
11009432|NCT01101958|OG001|Outcome|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
11009433|NCT01101958|EG000|Reported Event|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
11009434|NCT01101958|EG001|Reported Event|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
11143144|NCT01832506|FG002|Participant Flow|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143145|NCT01832506|OG000|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143146|NCT01832506|OG001|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143147|NCT01832506|OG002|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143148|NCT01832506|OG000|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143149|NCT01832506|OG001|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143150|NCT01832506|OG002|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143151|NCT01832506|OG000|Outcome|MSC2156119J 200 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143152|NCT01832506|OG000|Outcome|MSC2156119J Combined|All subjects who were administered with MSC2156119J 215 mg, 300mg or 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143153|NCT01832506|EG000|Reported Event|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143154|NCT01832506|EG001|Reported Event|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143155|NCT01832506|EG002|Reported Event|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
11143156|NCT01832532|BG000|Baseline|Treatment Group- Liraglutide|"Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.~liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose"
11143157|NCT01832532|BG001|Baseline|Control Group|Control group
11143158|NCT01832532|BG002|Baseline|Total|Total of all reporting groups
11143159|NCT01832532|FG000|Participant Flow|Treatment Group- Liraglutide|"Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.~liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose"
11143160|NCT01832532|FG001|Participant Flow|Control Group|Control group
11143161|NCT01832532|OG000|Outcome|Treatment Group- Liraglutide|"Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.~liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose"
11143162|NCT01832532|OG001|Outcome|Control Group|Control group
11143163|NCT01832532|EG000|Reported Event|Treatment Group- Liraglutide|"Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.~liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose"
11143164|NCT01832532|EG001|Reported Event|Control Group|Control group
11143165|NCT01832610|BG000|Baseline|HeartWare® VAS|"Ventricular Assist Device (HeartWare® VAS)~HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use."
11143166|NCT01832610|FG000|Participant Flow|HeartWare® VAS|"Ventricular Assist Device (HeartWare® VAS)~HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use."
11143167|NCT01832610|OG000|Outcome|HeartWare® VAS|"Ventricular Assist Device (HeartWare® VAS)~HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use."
11143168|NCT01832610|EG000|Reported Event|HeartWare® VAS|"Ventricular Assist Device (HeartWare® VAS)~HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use."
11143169|NCT01832727|BG000|Baseline|Cohort 180 mg 5/14 Schedule (Phase 1b)|Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143170|NCT01832727|BG001|Baseline|Cohort 210 mg 5/14 Schedule (Phase 1b)|"Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.~This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts."
11143171|NCT01832727|BG002|Baseline|Cohort 150/180 mg 5/14 Schedule (Phase 1b)|Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143172|NCT01832727|BG003|Baseline|Cohort 210 mg 2/7 Schedule (Phase 1b)|"Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.~This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts."
11149834|NCT01873989|OG001|Outcome|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
11143173|NCT01832727|BG004|Baseline|Cohort 240 mg 2/7 Schedule (Phase 1b)|Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143174|NCT01832727|BG005|Baseline|Cohort 270 mg 2/7 Schedule (Phase 1b)|Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143175|NCT01832727|BG006|Baseline|Cohort 300 mg 2/7 Schedule (Phase 1b)|Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143176|NCT01832727|BG007|Baseline|Cohort 330 mg 2/7 Schedule (Phase 1b)|Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143177|NCT01832727|BG008|Baseline|Phase 2 300 mg 2/7 Schedule|The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143178|NCT01832727|BG009|Baseline|Total|Total of all reporting groups
11143179|NCT01832727|FG000|Participant Flow|Cohort 180 mg 5/14 Schedule (Phase 1b)|Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143180|NCT01832727|FG001|Participant Flow|Cohort 210 mg 5/14 Schedule (Phase 1b)|"Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.~This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts."
11143181|NCT01832727|FG002|Participant Flow|Cohort 150/180 mg 5/14 Schedule (Phase 1b)|Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143182|NCT01832727|FG003|Participant Flow|Cohort 210 mg 2/7 Schedule (Phase 1b)|"Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.~This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts."
11143183|NCT01832727|FG004|Participant Flow|Cohort 240 mg 2/7 Schedule (Phase 1b)|Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143184|NCT01832727|FG005|Participant Flow|Cohort 270 mg 2/7 Schedule (Phase 1b)|Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143185|NCT01832727|FG006|Participant Flow|Cohort 300 mg 2/7 Schedule (Phase 1b)|Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143186|NCT01832727|FG007|Participant Flow|Cohort 330 mg 2/7 Schedule (Phase 1b)|Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143187|NCT01832727|FG008|Participant Flow|Phase 2 300 mg 2/7 Schedule|The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143188|NCT01832727|OG000|Outcome|Cohort 180 mg 5/14 Schedule (Phase 1b)|Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11149835|NCT01873989|EG000|Reported Event|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
10850952|NCT03410992|OG000|Outcome|Placebo (SS)|Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS).
11143189|NCT01832727|OG001|Outcome|Cohort 210 mg 5/14 Schedule (Phase 1b)|"Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.~This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts."
11143190|NCT01832727|OG002|Outcome|Cohort 150/180 mg 5/14 Schedule (Phase 1b)|Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143191|NCT01832727|OG003|Outcome|Cohort 210 mg 2/7 Schedule (Phase 1b)|"Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.~This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts."
11143192|NCT01832727|OG004|Outcome|Cohort 240 mg 2/7 Schedule (Phase 1b)|Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143193|NCT01832727|OG005|Outcome|Cohort 270 mg 2/7 Schedule (Phase 1b)|Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143194|NCT01832727|OG006|Outcome|Cohort 300 mg 2/7 Schedule (Phase 1b)|Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143195|NCT01832727|OG007|Outcome|Cohort 330 mg 2/7 Schedule (Phase 1b)|Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143196|NCT01832727|OG008|Outcome|Phase 2 300 mg 2/7 Schedule|The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143197|NCT01832727|OG000|Outcome|Phase 2 300 mg 2/7 Schedule|The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143198|NCT01832727|OG000|Outcome|180 mg Oprozomib Tablet|Participants who were administered 180 mg oprozomib tablets.
11143199|NCT01832727|OG001|Outcome|210 mg Oprozomib Tablet|Participants who were administered 210 mg oprozomib tablets.
11143200|NCT01832727|OG002|Outcome|240 mg Oprozomib Tablet|Participants who were administered 240 mg oprozomib tablets.
11143201|NCT01832727|OG003|Outcome|270 mg Oprozomib Tablet|Participants who were administered 270 mg oprozomib tablets.
11143202|NCT01832727|OG004|Outcome|300 mg Oprozomib Tablet|Participants who were administered 300 mg oprozomib tablets.
11143203|NCT01832727|OG005|Outcome|150 mg Oprozomib ER Tablet|Participants who were administered 150 mg extended release oprozomib tablets.
11143204|NCT01832727|OG006|Outcome|300 mg Oprozomib ER Tablet|Participants who were administered 300 mg extended release oprozomib tablets.
11143205|NCT01832727|OG007|Outcome|330 mg Oprozomib ER Tablet|Participants who were administered 330 mg extended release oprozomib tablets.
11143206|NCT01832727|EG000|Reported Event|Cohort 180 mg 5/14 Schedule (Phase 1b)|"Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule).~Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason."
11143207|NCT01832727|EG001|Reported Event|Cohort 210 mg 5/14 Schedule (Phase 1b)|"Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule).~Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts."
11143208|NCT01832727|EG002|Reported Event|Cohort 150/180 mg 5/14 Schedule (Phase 1b)|"Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward.~Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason."
11143209|NCT01832727|EG003|Reported Event|Cohort 210 mg 2/7 Schedule (Phase 1b)|"Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.~This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts."
11143210|NCT01832727|EG004|Reported Event|Cohort 240 mg 2/7 Schedule (Phase 1b)|Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143211|NCT01832727|EG005|Reported Event|Cohort 270 mg 2/7 Schedule (Phase 1b)|Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143212|NCT01832727|EG006|Reported Event|Cohort 300 mg 2/7 Schedule (Phase 1b)|Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143213|NCT01832727|EG007|Reported Event|Cohort 330 mg 2/7 Schedule (Phase 1b)|Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143214|NCT01832727|EG008|Reported Event|Phase 2 300 mg 2/7 Schedule|The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14- day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
11143215|NCT01832753|BG000|Baseline|Immediate Treatment|"Subjects in this group were observed during months 0-6, were randomized to receive levothyroxine during months 6-12, and received levothyroxine as part of the open label phase months 12-18.~All doses were between between 0.5 - 1 mcg/kg/day."
11143216|NCT01832753|BG001|Baseline|Delayed Treatment|"Subjects in this group were observed during months 0-6, were randomized to receive placebo during months 6-12, and received levothyroxine as part of the open label phase months 12-18.~All doses were between between 0.5 - 1 mcg/kg/day."
11143217|NCT01832753|BG002|Baseline|Observation Only|Subjects in this group partook in the study during the observational phase months 0-6. Subjects in this group were not randomized to either immediate or delayed treatment groups.
11143218|NCT01832753|BG003|Baseline|Total|Total of all reporting groups
11143219|NCT01832753|FG000|Participant Flow|Immediate Treatment|"Subjects in this group were observed during months 0-6, were randomized to receive levothyroxine during months 6-12, and received levothyroxine as part of the open label phase months 12-18.~All doses were between between 0.5 - 1 mcg/kg/day."
11143220|NCT01832753|FG001|Participant Flow|Delayed Treatment|"Subjects in this group were observed during months 0-6, were randomized to receive placebo during months 6-12, and received levothyroxine as part of the open label phase months 12-18.~All doses were between between 0.5 - 1 mcg/kg/day."
11143221|NCT01832753|FG002|Participant Flow|Observation Only|Subjects in this group partook in the study during the observational phase months 0-6. Subjects in this group were not randomized to either immediate or delayed treatment groups.
11143222|NCT01832753|OG000|Outcome|Immediate Treatment|"Subjects in this group were observed during months 0-6, were randomized to receive levothyroxine during months 6-12, and received levothyroxine as part of the open label phase months 12-18.~All doses were between between 0.5 - 1 mcg/kg/day."
11143223|NCT01832753|OG001|Outcome|Delayed Treatment|"Subjects in this group were observed during months 0-6, were randomized to receive placebo during months 6-12, and received levothyroxine as part of the open label phase months 12-18.~All doses were between between 0.5 - 1 mcg/kg/day."
11143224|NCT01832753|OG002|Outcome|Observation Only|Subjects in this group partook in the study during the observational phase months 0-6. Subjects in this group were not randomized to either immediate or delayed treatment groups.
11143225|NCT01832753|EG000|Reported Event|Observation Phase|"Months 0-6~Subjects will be observed for the first 6 months of the study to ensure that the subclinical hypothyroidism is persistent. Subjects who do not have SCH at 6 months will not proceed to the treatment phase.~Subjects that have TSH >10 mIU/L during the 6 month Observational Phase will not be considered subclinical and will not qualify to continue the study. They will be referred to an endocrinologist for treatment."
11143226|NCT01832753|EG001|Reported Event|Randomization Phase - Placebo|"Months 6-12~This group includes those 4 out of 12 participants that were randomized to the delayed treatment group and received placebo for months 6-12. Adverse events will be reported in this column of the table if the AEs occurred during the phase in which participants were receiving placebo."
11143227|NCT01832753|EG002|Reported Event|Randomization Phase - Treatment|"Months 6-12~This group includes those 5 of 12 participants that were randomized to immediate treatment. Levothyroxine dose is between 0.5 - 1 mcg/kg/day. There is 1 blood draw visit at month 7.5 (6 weeks after randomization) and 1 study visit at month 12 that will provide the opportunity for dose adjustments if needed.~From months 12-18, all subjects will receive levothyroxine. Levothyroxine dose will be between 0.5 - 1 mcg/kg/day. There will be one blood draw visit at month 13.5 that will provide the opportunity for dose adjustments if needed."
11149836|NCT01873989|EG001|Reported Event|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
11143228|NCT01832753|EG003|Reported Event|Open Label Treatment Phase|"Months 12-18~6 of the starting 12 participants took part in this phase of the study; 3 from the delayed treatment aka placebo group, 3 from the immediate treatment group. From months 12-18, all subjects receive levothyroxine. Levothyroxine dose is between 0.5 - 1 mcg/kg/day. There is one blood draw visit at month 13.5 that will provide the opportunity for dose adjustments if needed."
11143229|NCT01832766|BG000|Baseline|Entire Study Population|includes groups randomized to receive placebo first or dronabinol 10 mg first
11143230|NCT01832766|FG000|Participant Flow|Dronabinol 10 mg First Then Placebo|dronabinol 10 mg given oral one dose in first intervention period then 1 week washout period and then placebo given oral in one dose in second intervention period
11143231|NCT01832766|FG001|Participant Flow|Placebo First Then 10 mg Dronabinol|identical capsule given orally once in first intervention period then 1 week washout period then dronabinol 10 mg given orally once in second intervention period
11143232|NCT01832766|OG000|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
11143233|NCT01832766|OG001|Outcome|Placebo|identical capsule given once
11143234|NCT01832766|EG000|Reported Event|Dronabinol|dronabinol 10 mg given oral one dose
11143235|NCT01832766|EG001|Reported Event|Placebo|identical capsule given once
11143236|NCT01832818|BG000|Baseline|NuNec Cervical Disc|"Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.~NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7."
11143237|NCT01832818|FG000|Participant Flow|NuNec Cervical Disc|"Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.~NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7."
11143238|NCT01832818|OG000|Outcome|NuNec Cervical Disc|"Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.~NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7."
11143239|NCT01832818|EG000|Reported Event|NuNec Cervical Disc|"Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.~NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7."
11143240|NCT01832961|BG000|Baseline|All Patient|"All volunteers had a following treatments as crossover design Visit 1: medical history, physical examination and written informed consent~Visit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device~Visit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises~Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device"
11143241|NCT01832961|FG000|Participant Flow|Flutter Valve, Then Flutter Sham and Flutter+Bronchodilator|"Visit 1: medical history, physical examination and written informed consent~Visit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device~Visit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises~Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device"
11143242|NCT01832961|FG001|Participant Flow|Flutter Sham, Then Flutter Valve and Flutter+Bronchodilator|"Visit 1: medical history, physical examination and written informed consent~Visit 2: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises~Visit 3: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device~Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device"
11143243|NCT01832961|OG000|Outcome|Flutter Exercises Session|30 minutes of breathing exercises with flutter device
11143244|NCT01832961|OG001|Outcome|Flutter+Bronchodilator Session|Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
11143245|NCT01832961|OG002|Outcome|Flutter-sham - Control Group|30 minutes of exercise with flutter-sham device
11143246|NCT01832961|OG002|Outcome|Flutter-sham - Control Group|30 minutes of breathing exercises with flutter-sham device
11143247|NCT01832961|OG002|Outcome|Flutter-sham - Control Group|30 minutes of breathing exercise with flutter-sham device
11143248|NCT01832961|OG000|Outcome|Flutter Exercises|Flutter exercises: 30 minutes of breathing exercises with flutter device
11143249|NCT01832961|OG001|Outcome|Flutter-sham|Flutter-sham: 30 minutes of flutter-sham exercises
11143250|NCT01832961|OG002|Outcome|Flutter+Bronchodilator|Flutter+bronchodilator: Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
11143251|NCT01832961|OG001|Outcome|Flutter-sham Exercises Session|30 minutes of breathing exercises with a flutter-sham device
11143252|NCT01832961|OG002|Outcome|Flutter+Bronchodilator Session|Pretreatment with a short-acting bronchodilator and 01 hour later they performed flutter exercises during 30 minutes
11143253|NCT01832961|EG000|Reported Event|Flutter Exercises|Flutter exercises: 30 minutes of breathing exercises with flutter device
11143254|NCT01832961|EG001|Reported Event|Flutter-sham|Flutter-sham: 30 minutes of flutter-sham exercises
11143255|NCT01832961|EG002|Reported Event|Flutter+Bronchodilator|Flutter+bronchodilator: Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
11143256|NCT01833026|BG000|Baseline|COPD Assessment and Management Recommendations|"Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference.~Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews."
11149837|NCT01874054|BG000|Baseline|Brentuximab Vedotin + Bendamustine|"brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion~bendamustine: 90 mg/m^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion"
11143257|NCT01833026|BG001|Baseline|Usual Care|"Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care.~Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference."
11143258|NCT01833026|BG002|Baseline|Total|Total of all reporting groups
11143259|NCT01833026|FG000|Participant Flow|Usual Care|"Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care.~Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference."
11143260|NCT01833026|FG001|Participant Flow|Intervention|"Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care.~Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference.~Spirometry test: For the initial visit for the intervention group, an initial demographics form and a health questionnaire will given to the subject to complete. To evaluate the breathing and quality of living, a spirometry test"
11143261|NCT01833026|OG000|Outcome|COPD Assessment and Management Recommendations|"Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference.~Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews."
11143262|NCT01833026|OG001|Outcome|Usual Care|"Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care.~Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference."
11143263|NCT01833026|EG000|Reported Event|COPD Assessment and Management Recommendations|"Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference.~Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews."
11143264|NCT01833026|EG001|Reported Event|Usual Care|"Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care.~Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference."
11143265|NCT01833065|BG000|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form.
11143266|NCT01833065|BG001|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form.
11143267|NCT01833065|BG002|Baseline|PLCBO|Placebo was administered orally in a tablet form.
11143268|NCT01833065|BG003|Baseline|Total|Total of all reporting groups
11143269|NCT01833065|FG000|Participant Flow|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
11143270|NCT01833065|FG001|Participant Flow|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
11143271|NCT01833065|FG002|Participant Flow|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
11143272|NCT01833065|FG003|Participant Flow|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
11143273|NCT01833065|FG004|Participant Flow|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
11143274|NCT01833065|OG000|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
11143275|NCT01833065|OG001|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
11143276|NCT01833065|OG002|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
11143277|NCT01833065|EG000|Reported Event|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
11143278|NCT01833065|EG001|Reported Event|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
11143279|NCT01833065|EG002|Reported Event|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period.
11143280|NCT01833065|EG003|Reported Event|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
11143281|NCT01833065|EG004|Reported Event|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
11143282|NCT01833078|BG000|Baseline|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
11143283|NCT01833078|FG000|Participant Flow|Ghrelin|All participants received 7.5 mcg/kg of ghrelin as a once daily subcutaneous dose for seven consecutive days. Days 1, 2 and 7 will be in the research center. Days 3,4,5,and 6 will be self administered at home.
11143284|NCT01833078|OG000|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
11143285|NCT01833078|EG000|Reported Event|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
11143286|NCT01833117|BG000|Baseline|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
11143287|NCT01833117|BG001|Baseline|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
11143288|NCT01833117|BG002|Baseline|Total|Total of all reporting groups
11143289|NCT01833117|FG000|Participant Flow|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
11143290|NCT01833117|FG001|Participant Flow|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
11143291|NCT01833117|OG000|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
11143292|NCT01833117|OG001|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
11143293|NCT01833117|EG000|Reported Event|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
11143294|NCT01833117|EG001|Reported Event|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
11143295|NCT01833130|BG000|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
11143296|NCT01833130|BG001|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
11143297|NCT01833130|BG002|Baseline|Total|Total of all reporting groups
11143298|NCT01833130|FG000|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
11143299|NCT01833130|FG001|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
11143300|NCT01833130|OG000|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
11143301|NCT01833130|OG001|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
11143302|NCT01833130|EG000|Reported Event|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
11143303|NCT01833130|EG001|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
11143304|NCT01833143|BG000|Baseline|Bortezomib|Bortezomib will be administered by subcutaneous injection twice weekly for 2 weeks (Days 1, 4, 8, and 11) at 1.3 mg/m2/dose followed by a 10-day rest period for a 21 day cycle. Dose modifications are permitted as per a prescribed algorithm. Acyclovir at 400mg daily is recommended as prophylaxis for herpes zoster. Restaging scans, with evaluation of response, will be done every 2 cycles (6 weeks of treatment ± 7 days). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 2 weeks, or at the discretion of the treating physician or patient.
11143305|NCT01833143|FG000|Participant Flow|Bortezomib|Bortezomib will be administered by subcutaneous injection twice weekly for 2 weeks (Days 1, 4, 8, and 11) at 1.3 mg/m2/dose followed by a 10-day rest period for a 21 day cycle. Dose modifications are permitted as per a prescribed algorithm. Acyclovir at 400mg daily is recommended as prophylaxis for herpes zoster. Restaging scans, with evaluation of response, will be done every 2 cycles (6 weeks of treatment ± 7 days). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 2 weeks, or at the discretion of the treating physician or patient.
11224631|NCT02362191|FG000|Participant Flow|Single Session tACS Across Menstrual Cycle|"Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle.~Alternating Current Stimulator: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11224632|NCT02362191|OG000|Outcome|Single Session tACS Across Menstrual Cycle|"Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle.~Alternating Current Stimulator: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11224633|NCT02362191|EG000|Reported Event|Single Session tACS Across Menstrual Cycle|"Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle.~Alternating Current Stimulator: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11224634|NCT02362269|BG000|Baseline|Control Group|"The control group will receive 2500 IU of vitamin D3 daily.~Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits."
11224635|NCT02362269|BG001|Baseline|Dosing Algorithm Group|"The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.~Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits."
11224636|NCT02362269|BG002|Baseline|Total|Total of all reporting groups
11224637|NCT02362269|FG000|Participant Flow|Control Group|"The control group will receive 2500 IU of vitamin D3 daily.~Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits."
11224638|NCT02362269|FG001|Participant Flow|Dosing Algorithm Group|"The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.~Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits."
11224639|NCT02362269|OG000|Outcome|Control Group|"The control group will receive 2500 IU of vitamin D3 daily.~Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits."
11224640|NCT02362269|OG001|Outcome|Dosing Algorithm Group|"The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.~Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits."
11224641|NCT02362269|EG000|Reported Event|Control Group|"The control group will receive 2500 IU of vitamin D3 daily.~Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits."
11224642|NCT02362269|EG001|Reported Event|Dosing Algorithm Group|"The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.~Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits."
11224643|NCT02362282|BG000|Baseline|Gait and Cognitive Training|Gait rehabilitation combined with cognitive rehabilitation
11224644|NCT02362282|BG001|Baseline|Gait and Arm Training|Gait rehabilitation combined with arm (reach/grasp) rehabilitation
11224645|NCT02362282|BG002|Baseline|Total|Total of all reporting groups
11224646|NCT02362282|FG000|Participant Flow|Gait and Cognitive Training|Gait rehabilitation combined with cognitive rehabilitation
11224647|NCT02362282|FG001|Participant Flow|Gait and Arm Training|Gait rehabilitation combined with arm (reach/grasp) rehabilitation
11224648|NCT02362282|OG000|Outcome|Gait and Cognitive Training|Gait rehabilitation combined with cognitive rehabilitation
11224649|NCT02362282|OG001|Outcome|Gait and Arm Training|Gait rehabilitation combined with arm (reach/grasp) rehabilitation
11224650|NCT02362282|EG000|Reported Event|Gait and Cognitive Training|Gait rehabilitation combined with cognitive rehabilitation
11224651|NCT02362282|EG001|Reported Event|Gait and Arm Training|Gait rehabilitation combined with arm (reach/grasp) rehabilitation
11143306|NCT01833143|OG000|Outcome|Bortezomib|Bortezomib will be administered by subcutaneous injection twice weekly for 2 weeks (Days 1, 4, 8, and 11) at 1.3 mg/m2/dose followed by a 10-day rest period for a 21 day cycle. Dose modifications are permitted as per a prescribed algorithm. Acyclovir at 400mg daily is recommended as prophylaxis for herpes zoster. Restaging scans, with evaluation of response, will be done every 2 cycles (6 weeks of treatment ± 7 days). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 2 weeks, or at the discretion of the treating physician or patient.
11143307|NCT01833143|EG000|Reported Event|Bortezomib|Bortezomib will be administered by subcutaneous injection twice weekly for 2 weeks (Days 1, 4, 8, and 11) at 1.3 mg/m2/dose followed by a 10-day rest period for a 21 day cycle. Dose modifications are permitted as per a prescribed algorithm. Acyclovir at 400mg daily is recommended as prophylaxis for herpes zoster. Restaging scans, with evaluation of response, will be done every 2 cycles (6 weeks of treatment ± 7 days). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 2 weeks, or at the discretion of the treating physician or patient.
11143308|NCT01833169|BG000|Baseline|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
11143309|NCT01833169|FG000|Participant Flow|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
11143310|NCT01833169|OG000|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
11143311|NCT01833169|EG000|Reported Event|BKM120|BKM120
11143312|NCT01833247|BG000|Baseline|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
11143313|NCT01833247|FG000|Participant Flow|Epilepsy Inpatients|Patients who have blood or salivary (or both) levels recorded after a seizure.
11143314|NCT01833247|OG000|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
11143315|NCT01833247|EG000|Reported Event|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
11143316|NCT01833403|BG000|Baseline|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~--------------------------------------------------------------------------------~Glucose"
11143317|NCT01833403|FG000|Participant Flow|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~--------------------------------------------------------------------------------~Glucose"
11143318|NCT01833403|OG000|Outcome|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~--------------------------------------------------------------------------------~Glucose"
11143319|NCT01833403|OG000|Outcome|Measurement of Insulin Sensitivity|"All participants will undergo a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~--------------------------------------------------------------------------------"
11143320|NCT01833403|EG000|Reported Event|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~--------------------------------------------------------------------------------~Glucose"
11143321|NCT01833455|BG000|Baseline|PVC Suppression Then Placebo|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden."
11143322|NCT01833455|BG001|Baseline|Placebo Then PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden."
11143323|NCT01833455|BG002|Baseline|Total|Total of all reporting groups
11143324|NCT01833455|FG000|Participant Flow|PVC Suppression Then Placebo|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden."
11143325|NCT01833455|FG001|Participant Flow|Placebo Then PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden."
11143326|NCT01833455|OG000|Outcome|Change From Base 1 to PVC Suppression|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~Change in BP values from baseline to PVC suppression in the group that received flecainide (PVC suppression) first."
11149838|NCT01874054|FG000|Participant Flow|Brentuximab Vedotin + Bendamustine|"brentuximab vedotin (BV): 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion~bendamustine: 90 mg/m^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion"
11143327|NCT01833455|OG001|Outcome|Change From Base 2 to no PVC Suppression|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first."
11143328|NCT01833455|OG002|Outcome|Change From Base 1 to no PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~Change in BP values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first."
11143329|NCT01833455|OG003|Outcome|Change From Base 2 to PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first."
11143330|NCT01833455|OG000|Outcome|Change From Base 1 to PVC Suppression|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~Change in SNA values from baseline to PVC suppression in the group that received flecainide (PVC suppression) first."
11143331|NCT01833455|OG001|Outcome|Change From Base 2 to no PVC Suppression|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~Change in SNA values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first."
11143332|NCT01833455|OG002|Outcome|Change From Base 1 to no PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~Change in SNA values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first."
11143333|NCT01833455|OG003|Outcome|Change From Base 2 to PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~Change in SNA values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first."
11143334|NCT01833455|OG000|Outcome|Change From Base 1 to PVC Suppression|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~Change in baroreflex gain values from baseline to PVC suppression in the group that received flecainide (PVC suppression) first."
11143335|NCT01833455|OG001|Outcome|Change From Base 2 to no PVC Suppression|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~Change in baroreflex gain values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first."
11143336|NCT01833455|OG002|Outcome|Change From Base 1 to no PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~Change in baroreflex gain values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first."
11143337|NCT01833455|OG003|Outcome|Change From Base 2 to PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~Change in baroreflex gain values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first."
11143338|NCT01833455|EG000|Reported Event|Base 1 to PVC Suppression|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~Adverse events during baseline to PVC suppression in the group that received flecainide (PVC suppression) first."
11143339|NCT01833455|EG001|Reported Event|Base 2 to no PVC Suppression|"This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~Adverse events during 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first."
11149839|NCT01874054|OG000|Outcome|Brentuximab Vedotin + Bendamustine|"brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion~bendamustine: 90 mg/m^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion"
11143340|NCT01833455|EG002|Reported Event|Base 1 to no PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~Adverse events during first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first."
11143341|NCT01833455|EG003|Reported Event|Base 2 to PVC Suppression|"This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.~No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.~PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.~Adverse events during 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first."
11149840|NCT01874054|EG000|Reported Event|Brentuximab Vedotin + Bendamustine|"brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion~bendamustine: 90 mg/m^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion"
11149841|NCT01874119|BG000|Baseline|Study Participants Completing All Cycles|"Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission~Placebo: intravenous 0.9% saline every 48 hours during 6-day hospital admission"
11149842|NCT01874119|FG000|Participant Flow|Fosaprepitant First, Then Placebo|"Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission~Placebo: During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission"
11149843|NCT01874119|FG001|Participant Flow|Placebo First, Then Fosaprepitant|"Placebo: During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
11149844|NCT01874119|OG000|Outcome|Fosaprepitant|"During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
11149845|NCT01874119|OG001|Outcome|Placebo|"During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
11149846|NCT01874119|EG000|Reported Event|Fosaprepitant|"During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
11149847|NCT01874119|EG001|Reported Event|Placebo|"During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
11149848|NCT01874132|BG000|Baseline|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
11149849|NCT01874132|BG001|Baseline|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
11149850|NCT01874132|BG002|Baseline|Control|Non-exercising control group
11149851|NCT01874132|BG003|Baseline|Total|Total of all reporting groups
11149852|NCT01874132|FG000|Participant Flow|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
11149853|NCT01874132|FG001|Participant Flow|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
11149854|NCT01874132|FG002|Participant Flow|Control|Non-exercising control group
11149855|NCT01874132|OG000|Outcome|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
11149856|NCT01874132|OG001|Outcome|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
11149857|NCT01874132|OG002|Outcome|Control|Non-exercising control group
11149858|NCT01874132|EG000|Reported Event|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
11149859|NCT01874132|EG001|Reported Event|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
11149860|NCT01874132|EG002|Reported Event|Control|Non-exercising control group
11149861|NCT01874145|BG000|Baseline|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
11149862|NCT01874145|BG001|Baseline|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
11149863|NCT01874145|BG002|Baseline|Total|Total of all reporting groups
11149864|NCT01874145|FG000|Participant Flow|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
11149865|NCT01874145|FG001|Participant Flow|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
11149866|NCT01874145|OG000|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
11143342|NCT01833481|BG000|Baseline|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143343|NCT01833481|BG001|Baseline|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143344|NCT01833481|BG002|Baseline|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143345|NCT01833481|BG003|Baseline|Total|Total of all reporting groups
11143346|NCT01833481|FG000|Participant Flow|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143347|NCT01833481|FG001|Participant Flow|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143348|NCT01833481|FG002|Participant Flow|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143349|NCT01833481|OG000|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143350|NCT01833481|OG001|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143351|NCT01833481|OG002|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143352|NCT01833481|EG000|Reported Event|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143353|NCT01833481|EG001|Reported Event|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143354|NCT01833481|EG002|Reported Event|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
11143355|NCT01833494|BG000|Baseline|PA21|PA21
11143356|NCT01833494|FG000|Participant Flow|PA21|PA21
11143357|NCT01833494|OG000|Outcome|PA21|PA21
11143358|NCT01833494|EG000|Reported Event|PA21|PA21
11143359|NCT01833520|BG000|Baseline|Escalation|"Dose level: 50 kBq/kg, 75 kBq/kg and 100 kBq/kg. Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143360|NCT01833520|BG001|Baseline|Expansion|"Dose level: 100 kBq/kg. Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143361|NCT01833520|BG002|Baseline|Total|Total of all reporting groups
11143362|NCT01833520|FG000|Participant Flow|Escalation 50 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143363|NCT01833520|FG001|Participant Flow|Escalation 75 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143364|NCT01833520|FG002|Participant Flow|Escalation 100 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143365|NCT01833520|FG003|Participant Flow|Expansion 100 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143366|NCT01833520|OG000|Outcome|Escalation 100 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143367|NCT01833520|OG001|Outcome|Expansion 100 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143368|NCT01833520|OG000|Outcome|Escalation 50 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143369|NCT01833520|OG001|Outcome|Escalation 75 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143370|NCT01833520|OG002|Outcome|Escalation 100 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143371|NCT01833520|OG003|Outcome|Expansion 100 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143372|NCT01833520|EG000|Reported Event|Escalation 50 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143373|NCT01833520|EG001|Reported Event|Escalation 75 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143374|NCT01833520|EG002|Reported Event|Escalation 100 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143375|NCT01833520|EG003|Reported Event|Expansion 100 kBq/kg|"Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.~Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles."
11143376|NCT01833533|BG000|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11143377|NCT01833533|BG001|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
11143378|NCT01833533|BG002|Baseline|Total|Total of all reporting groups
11143379|NCT01833533|FG000|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11143380|NCT01833533|FG001|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
11143381|NCT01833533|OG000|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11143382|NCT01833533|OG001|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
11143383|NCT01833533|EG000|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11143384|NCT01833533|EG001|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
11143385|NCT01833546|BG000|Baseline|Evofosfamide 240 mg|Participants received evofosfamide infusion intravenously at a dose of 240 milligram per square meter (mg/m^2) on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143386|NCT01833546|BG001|Baseline|Evofosfamide 340 mg|Participants received evofosfamide infusion intravenously at a dose of 340 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143387|NCT01833546|BG002|Baseline|Evofosfamide 480 mg|Participants received evofosfamide infusion intravenously at a dose of 480 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143388|NCT01833546|BG003|Baseline|Evofosfamide 340 mg + Gemcitabine|Participants received 340 mg/m^2 evofosfamide in combination with 1,000 mg/m^2 gemcitabine intravenously on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143389|NCT01833546|BG004|Baseline|Total|Total of all reporting groups
11143390|NCT01833546|FG000|Participant Flow|Evofosfamide 240 mg|Participants received evofosfamide infusion intravenously at a dose of 240 milligram per square meter (mg/m^2) on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143391|NCT01833546|FG001|Participant Flow|Evofosfamide 340 mg|Participants received evofosfamide infusion intravenously at a dose of 340 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143392|NCT01833546|FG002|Participant Flow|Evofosfamide 480 mg|Participants received evofosfamide infusion intravenously at a dose of 480 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143393|NCT01833546|FG003|Participant Flow|Evofosfamide 340 mg + Gemcitabine|Participants received 340 mg/m^2 evofosfamide in combination with 1,000 mg/m^2 gemcitabine intravenously on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143394|NCT01833546|OG000|Outcome|Evofosfamide 240 mg|Participants received evofosfamide infusion intravenously at a dose of 240 milligram per square meter (mg/m^2) on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143395|NCT01833546|OG001|Outcome|Evofosfamide 340 mg|Participants received evofosfamide infusion intravenously at a dose of 340 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143396|NCT01833546|OG002|Outcome|Evofosfamide 480 mg|Participants received evofosfamide infusion intravenously at a dose of 480 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143397|NCT01833546|OG003|Outcome|Evofosfamide 340 mg + Gemcitabine|Participants received 340 mg/m^2 evofosfamide in combination with 1,000 mg/m^2 gemcitabine intravenously on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143398|NCT01833546|OG000|Outcome|Evofosfamide 340 mg + Gemcitabine|Participants received 340 mg/m^2 evofosfamide in combination with 1,000 mg/m^2 gemcitabine intravenously on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143399|NCT01833546|EG000|Reported Event|Evofosfamide 240 mg|Participants received evofosfamide infusion intravenously at a dose of 240 milligram per square meter (mg/m^2) on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143400|NCT01833546|EG001|Reported Event|Evofosfamide 340 mg|Participants received evofosfamide infusion intravenously at a dose of 340 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143401|NCT01833546|EG002|Reported Event|Evofosfamide 480 mg|Participants received evofosfamide infusion intravenously at a dose of 480 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143402|NCT01833546|EG003|Reported Event|Evofosfamide 340 mg + Gemcitabine|Participants received 340 mg/m^2 evofosfamide in combination with 1,000 mg/m^2 gemcitabine intravenously on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
11143403|NCT01833741|BG000|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
11143404|NCT01833741|FG000|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
11143405|NCT01833741|OG000|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
11143406|NCT01833741|EG000|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
11143407|NCT01833754|BG000|Baseline|Group 1: Stage 4 Renal Impairment|Participants with stage 4 renal impairment (defined as an estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143408|NCT01833754|BG001|Baseline|Group 2: ESRD Requiring Hemodialysis|Participants with end stage renal disease (ESRD) requiring hemodialysis received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143409|NCT01833754|BG002|Baseline|Group 3: Healthy Participants|Healthy participants (eGFR ≥ 80 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143410|NCT01833754|BG003|Baseline|Total|Total of all reporting groups
11143411|NCT01833754|FG000|Participant Flow|Group 1: Stage 4 Renal Impairment|Participants with stage 4 renal impairment (defined as an estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143412|NCT01833754|FG001|Participant Flow|Group 2: ESRD Requiring Hemodialysis|Participants with end stage renal disease (ESRD) requiring hemodialysis received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143413|NCT01833754|FG002|Participant Flow|Group 3: Healthy Participants|Healthy participants (eGFR ≥ 80 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143414|NCT01833754|OG000|Outcome|Group 1: Stage 4 Renal Impairment|Participants with stage 4 renal impairment (defined as an estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143415|NCT01833754|OG001|Outcome|Group 2: ESRD Requiring Hemodialysis|Participants with end stage renal disease (ESRD) requiring hemodialysis received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143416|NCT01833754|OG002|Outcome|Group 3: Healthy Participants|Healthy participants (eGFR ≥ 80 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143417|NCT01833754|EG000|Reported Event|Group 1: Stage 4 Renal Impairment|Participants with stage 4 renal impairment (defined as an estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143418|NCT01833754|EG001|Reported Event|Group 2: ESRD Requiring Hemodialysis|Participants with end stage renal disease (ESRD) requiring hemodialysis received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143419|NCT01833754|EG002|Reported Event|Group 3: Healthy Participants|Healthy participants (eGFR ≥ 80 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
11143420|NCT01833832|BG000|Baseline|Cytoreductive Surgery Followed by HIPEC|"Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin~Cisplatin: Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.~Cytoreductive surgery: Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.~sodium thiosulfate: sodium thiosulfate will be given to limit the toxicity of cisplatin"
11143421|NCT01833832|FG000|Participant Flow|Cytoreductive Surgery Followed by HIPEC|"Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin~Cisplatin: Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.~Cytoreductive surgery: Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.~sodium thiosulfate: sodium thiosulfate will be given to limit the toxicity of cisplatin"
11143422|NCT01833832|OG000|Outcome|Cytoreductive Surgery Followed by HIPEC|"Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin~Cisplatin: Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.~Cytoreductive surgery: Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.~sodium thiosulfate: sodium thiosulfate will be given to limit the toxicity of cisplatin"
11143423|NCT01833832|EG000|Reported Event|Cytoreductive Surgery Followed by HIPEC|"Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin~Cisplatin: Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.~Cytoreductive surgery: Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.~sodium thiosulfate: sodium thiosulfate will be given to limit the toxicity of cisplatin"
11143424|NCT01833845|BG000|Baseline|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
11143425|NCT01833845|FG000|Participant Flow|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
11143426|NCT01833845|OG000|Outcome|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
11143427|NCT01833845|EG000|Reported Event|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
11143428|NCT01833897|BG000|Baseline|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
11143429|NCT01833897|FG000|Participant Flow|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
11143430|NCT01833897|OG000|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
11143431|NCT01833897|EG000|Reported Event|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
11143432|NCT01833936|BG000|Baseline|Group 1- Compex® Muscle Stimulator|"Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.~Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy."
11143433|NCT01833936|BG001|Baseline|Group 2 -(Inactive) Muscle Stimulator|"Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.~(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day."
11143434|NCT01833936|BG002|Baseline|Total|Total of all reporting groups
11143435|NCT01833936|FG000|Participant Flow|Group 1- Compex® Muscle Stimulator|"Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.~Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy."
11143436|NCT01833936|FG001|Participant Flow|Group 2 -(Inactive) Muscle Stimulator|"Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.~(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day."
11143437|NCT01833936|OG000|Outcome|Group 1- Compex® Muscle Stimulator|"Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.~Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy."
11143438|NCT01833936|OG001|Outcome|Group 2 -(Inactive) Muscle Stimulator|"Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.~(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day."
11143439|NCT01833936|EG000|Reported Event|Group 1- Compex® Muscle Stimulator|"Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.~Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy."
11143440|NCT01833936|EG001|Reported Event|Group 2 -(Inactive) Muscle Stimulator|"Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.~(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day."
11143441|NCT01833988|BG000|Baseline|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
11143442|NCT01833988|FG000|Participant Flow|Bionic Pancreas Then Usual Care|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.~In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between."
11143443|NCT01833988|FG001|Participant Flow|Usual Care Then Bionic Pancreas|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.~In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between."
11143444|NCT01833988|OG000|Outcome|Bionic Pancreas|
11143445|NCT01833988|OG001|Outcome|Control|
11143446|NCT01833988|OG001|Outcome|Standard Care (Insulin Pump)|
11143447|NCT01833988|OG000|Outcome|Bionic Pancreas|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.~In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 1 day washout period in between."
11143448|NCT01833988|OG000|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
11143449|NCT01833988|OG001|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
11143450|NCT01833988|OG000|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
11143451|NCT01833988|EG000|Reported Event|Bionic Pancreas|
11143452|NCT01833988|EG001|Reported Event|Control|
11143453|NCT01834027|BG000|Baseline|Jazz Music|"Jazz music will be played through noise-cancelling headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
11143454|NCT01834027|BG001|Baseline|No Music|"The patients in this group will have noise-cancelling headphones but no music will be played.~No music: In this group, noise-cancelling headphones will be worn, but no music will be played in PACU"
11143455|NCT01834027|BG002|Baseline|Total|Total of all reporting groups
11143456|NCT01834027|FG000|Participant Flow|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
11143457|NCT01834027|FG001|Participant Flow|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
11143458|NCT01834027|OG000|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
11143459|NCT01834027|OG001|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
11143460|NCT01834027|EG000|Reported Event|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
11143461|NCT01834027|EG001|Reported Event|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
11143462|NCT01834222|BG000|Baseline|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
11143463|NCT01834222|FG000|Participant Flow|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 milliliter (mL) intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
11143464|NCT01834222|OG000|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
11143465|NCT01834222|EG000|Reported Event|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
11143466|NCT01834261|BG000|Baseline|Oxytocin, Then Placebo|"Healthy adult subjects received several puffs of Syntocinon Nasal Spray, 40IU, once, prior to MRI and/or MEG scanning.~This group contains subjects who received oxytocin prior to first scan and placebo prior to second scan."
11143467|NCT01834261|BG001|Baseline|Placebo, Then Oxytocin|"Healthy adult subjects received several puffs of Syntocinon Placebo Formulation, 40IU, once, prior to MRI and/or MEG scanning.~This group contains subjects who received placebo prior to first scan and oxytocin prior to second scan."
11143468|NCT01834261|BG002|Baseline|Total|Total of all reporting groups
11143469|NCT01834261|FG000|Participant Flow|Oxytocin, Then Placebo|Healthy adult subjects who received oxytocin before their first scan, and placebo before their second scan.
11143470|NCT01834261|FG001|Participant Flow|Placebo, Then Oxytocin|Healthy adult subjects who received placebo before their first scan, and oxytocin before their second scan.
11143471|NCT01834261|OG000|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
11143472|NCT01834261|OG001|Outcome|Placebo|Subjects received placebo prior to the scan.
11143473|NCT01834261|EG000|Reported Event|Oxytocin, Then Placebo|Subjects who received oxytocin before their first scan, and placebo before their second scan.
11143474|NCT01834261|EG001|Reported Event|Placebo, Then Oxytocin|Subjects who received placebo before their first scan, and oxytocin before their second scan.
11143475|NCT01834274|BG000|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
11143476|NCT01834274|BG001|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
11143477|NCT01834274|BG002|Baseline|Total|Total of all reporting groups
11143478|NCT01834274|FG000|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
11143479|NCT01834274|FG001|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
11143480|NCT01834274|OG000|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
11143481|NCT01834274|OG001|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
11143482|NCT01834274|EG000|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
11143483|NCT01834274|EG001|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
11143484|NCT01834326|BG000|Baseline|Palatal Oral Mucosa (POM) Graft|"Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area~POM (Palatal oral mucosa): POM is a tissue graft harvested from the palate and surgically placed into the defect area"
11143485|NCT01834326|BG001|Baseline|Ex Vivo Produced Oral Mucosa Equivalent|"Palatal biopsy will be harvested for fabrication of autogenous ex vivo produced oral mucosa equivalent (EVPOME) and then surgically placed onto the defect area~EVPOME (autogenous ex vivo produced oral mucosa equivalent): EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process."
11143486|NCT01834326|BG002|Baseline|Total|Total of all reporting groups
11143487|NCT01834326|FG000|Participant Flow|Palatal Oral Mucosa (POM) Graft|"Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area~POM (Palatal oral mucosa): POM is a tissue graft harvested from the palate and surgically placed into the defect area"
11143488|NCT01834326|FG001|Participant Flow|Ex Vivo Produced Oral Mucosa Equivalent|"Palatal biopsy will be harvested for fabrication of autogenous ex vivo produced oral mucosa equivalent (EVPOME) and then surgically placed onto the defect area~EVPOME (autogenous ex vivo produced oral mucosa equivalent): EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process."
11143489|NCT01834326|OG000|Outcome|Palatal Oral Mucosa (POM) Graft|"Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area~POM (Palatal oral mucosa): POM is a tissue graft harvested from the palate and surgically placed into the defect area"
11143490|NCT01834326|OG001|Outcome|Ex Vivo Produced Oral Mucosa Equivalent|"Palatal biopsy will be harvested for fabrication of autogenous ex vivo produced oral mucosa equivalent (EVPOME) and then surgically placed onto the defect area~EVPOME (autogenous ex vivo produced oral mucosa equivalent): EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process."
11143491|NCT01834326|EG000|Reported Event|Palatal Oral Mucosa (POM) Graft|"Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area~POM (Palatal oral mucosa): POM is a tissue graft harvested from the palate and surgically placed into the defect area"
11143492|NCT01834326|EG001|Reported Event|Ex Vivo Produced Oral Mucosa Equivalent|"Palatal biopsy will be harvested for fabrication of autogenous ex vivo produced oral mucosa equivalent (EVPOME) and then surgically placed onto the defect area~EVPOME (autogenous ex vivo produced oral mucosa equivalent): EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process."
11143493|NCT01834404|BG000|Baseline|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
11143494|NCT01834404|BG001|Baseline|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
11143495|NCT01834404|BG002|Baseline|Total|Total of all reporting groups
11143496|NCT01834404|FG000|Participant Flow|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
11143497|NCT01834404|FG001|Participant Flow|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
11143498|NCT01834404|OG000|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
11143499|NCT01834404|OG001|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
11143500|NCT01834404|EG000|Reported Event|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
11143501|NCT01834404|EG001|Reported Event|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
11143502|NCT01834586|BG000|Baseline|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
11143503|NCT01834586|FG000|Participant Flow|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
11143504|NCT01834586|OG000|Outcome|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
11143505|NCT01834586|EG000|Reported Event|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
11143506|NCT01834651|BG000|Baseline|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
11143507|NCT01834651|FG000|Participant Flow|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
11143508|NCT01834651|OG000|Outcome|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
11143509|NCT01834651|OG000|Outcome|Treatment (Cabozantinib) HGF Levels|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
11143510|NCT01834651|OG001|Outcome|Treatment (Cabozantinib) VEGF Levels|Carbozantinib 60mg
11143511|NCT01834651|EG000|Reported Event|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
11143512|NCT01834716|BG000|Baseline|Non-aerobics Exercise|Participants in this group will be randomized to a non-aerobics exercise group (attending classes of toning and stretching a minimum of three times per week).
11143513|NCT01834716|BG001|Baseline|Aerobics Exercise|Participants in this group will be randomized to an aerobics exercise group (the equivalent of walking briskly for 50 minutes three times per week).
11143514|NCT01834716|BG002|Baseline|Total|Total of all reporting groups
11143515|NCT01834716|FG000|Participant Flow|Non-Aerobics Exercise|Participants in this group will be randomized to a non-aerobics(attending classes of toning and stretching a minimum of three times per week) exercise group.
11143516|NCT01834716|FG001|Participant Flow|Aerobics Exercise|Participants in this group will be randomized to an aerobics exercise group (the equivalent of walking briskly for 50 minutes three times per week).
11143517|NCT01834716|OG000|Outcome|Aerobics Exercise|"Participants in this group will be randomized to aerobics exercise.~Aerobic vs. Non-Aerobic exercise~12 enrolled 11 completed"
11143518|NCT01834716|OG001|Outcome|Non-Aerobics Exercise|"Participants in this group will be randomized to a non-aerobics exercise group.~Aerobic vs. Non-Aerobic exercise~4 enrolled and 4 completed"
11143519|NCT01834716|EG000|Reported Event|Aerobics Exercise|Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week).
11009435|NCT01101971|BG000|Baseline|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
11009436|NCT01101971|FG000|Participant Flow|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
11009437|NCT01101971|OG000|Outcome|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
11009438|NCT01101971|EG000|Reported Event|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
11065991|NCT01390584|OG000|Outcome|ABVD + BEACOPP + INRT|"Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.~PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.~BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.~Doxorubicin: IV~Bleomycin: IV~Vinblastine: IV~PET: fludeoxyglucose F 18 Imaging exam~INRT: selective external radiation therapy~Dacarbazine: IV~Etoposide: IV~Cyclophosphamide: May be given orally, IV push, or by IV infusion~Vincristine: IV~Procarbazine: PO~Prednisone: PO"
11065992|NCT01390584|EG000|Reported Event|Step 1: Induction Treatment|"Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.~PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). Patients will be assigned to Step 2 treatments (either ABVD + INRT or BEACOPP + INRT) depending on the scan results (negative or positive)."
11065993|NCT01390584|EG001|Reported Event|Step 2: ABVD + INRT|ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
11065994|NCT01390584|EG002|Reported Event|Step 2: BEACOPP + INRT|BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
11065995|NCT01390649|BG000|Baseline|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
11065996|NCT01390649|FG000|Participant Flow|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
11065997|NCT01390649|OG000|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
11065998|NCT01390649|EG000|Reported Event|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
11065999|NCT01390779|BG000|Baseline|SENSIMED Triggerfish|
11066000|NCT01390779|FG000|Participant Flow|SENSIMED Triggerfish|"All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.~Parallel IOP measurements were taken using pneumatonometry on the eye contralateral to the SENSIMED Triggerfish eye before and after sleep onset. During sleep heart rate measurements were collected at specified time points."
11066001|NCT01390779|OG000|Outcome|SENSIMED Triggerfish|
11066002|NCT01390779|EG000|Reported Event|SENSIMED Triggerfish|
11143520|NCT01834716|EG001|Reported Event|Non-Aerobics Exercise|Participants in this group will be randomized to a non-aerobics exercise group (attending classes of toning and stretching a minimum of three times per week).
11143521|NCT01834729|BG000|Baseline|Control Placebo|"Subjects randomized to this arm will receive a placebo capsule identical to the study drug.~Placebo: placebo capsule identical to the study drug"
11143522|NCT01834729|BG001|Baseline|Control Alfuzosin|Subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.
11143523|NCT01834729|BG002|Baseline|Constipation Placebo|"Subjects randomized to this arm will receive a placebo capsule identical to the study drug.~Placebo: placebo capsule identical to the study drug"
11143524|NCT01834729|BG003|Baseline|Constipation Alfuzosin|"In this arm, only constipated patients will receive oral alfuzosin (10 mg extended release (ER)) capsules.~Alfuzosin: oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B)"
11143525|NCT01834729|BG004|Baseline|Total|Total of all reporting groups
11143526|NCT01834729|FG000|Participant Flow|Control Placebo|Healthy subjects defined as not having a functional bowel disorder randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug.
11143527|NCT01834729|FG001|Participant Flow|Control Alfuzosin|Healthy subjects defined as not having a functional bowel disorder randomized to this arm will receive a receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.
11143528|NCT01834729|FG002|Participant Flow|Constipation Placebo|Subjects with constipation for 1 year or longer randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug
11143529|NCT01834729|FG003|Participant Flow|Constipation Alfuzosin|Subjects with constipation for 1 year or longer randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.
11143530|NCT01834729|OG000|Outcome|Control Placebo|"Subjects randomized to this arm will receive a placebo capsule identical to the study drug.~Placebo: placebo capsule identical to the study drug"
11143531|NCT01834729|OG001|Outcome|Control Alfuzosin|Subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.
11143532|NCT01834729|OG002|Outcome|Constipation Placebo|"Subjects randomized to this arm will receive a placebo capsule identical to the study drug.~Placebo: placebo capsule identical to the study drug"
11143533|NCT01834729|OG003|Outcome|Constipation Alfuzosin|Constipated patients will receive oral alfuzosin (10 mg extended release (ER) capsules.
11143534|NCT01834729|OG003|Outcome|Constipation Alfuzosin|Constipated patients will receive oral alfuzosin (10 mg extended release (ER)) capsules.
11143535|NCT01834729|EG000|Reported Event|Control Placebo|"Subjects randomized to this arm will receive a placebo capsule identical to the study drug.~Placebo: placebo capsule identical to the study drug"
11143536|NCT01834729|EG001|Reported Event|Control Alfuzosin|Subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.
11143537|NCT01834729|EG002|Reported Event|Constipation Placebo|"Subjects randomized to this arm will receive a placebo capsule identical to the study drug.~Placebo: placebo capsule identical to the study drug"
11143538|NCT01834729|EG003|Reported Event|Constipation Afluzosin|Constipated patients will receive oral alfuzosin (10 mg extended release (ER)) capsules.
11143539|NCT01835015|BG000|Baseline|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
11143540|NCT01835015|BG001|Baseline|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
11143541|NCT01835015|BG002|Baseline|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
11143542|NCT01835015|BG003|Baseline|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
11143543|NCT01835015|BG004|Baseline|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
11143544|NCT01835015|BG005|Baseline|Total|Total of all reporting groups
11143545|NCT01835015|FG000|Participant Flow|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
11143546|NCT01835015|FG001|Participant Flow|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
11143547|NCT01835015|FG002|Participant Flow|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
11143548|NCT01835015|FG003|Participant Flow|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
11143549|NCT01835015|FG004|Participant Flow|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
11143550|NCT01835015|OG000|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
11143551|NCT01835015|OG001|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
11143552|NCT01835015|OG002|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
11143553|NCT01835015|OG003|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
11143554|NCT01835015|OG004|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
11143555|NCT01835015|EG000|Reported Event|CLG561, Level A|Reported subsequent to the initiation of treatment
11143556|NCT01835015|EG001|Reported Event|CLG561, Level B|Reported subsequent to the initiation of treatment
11143557|NCT01835015|EG002|Reported Event|CLG561, Level C|Reported subsequent to the initiation of treatment
11143558|NCT01835015|EG003|Reported Event|CLG561, Level D|Reported subsequent to the initiation of treatment
11143559|NCT01835015|EG004|Reported Event|CLG561, Level E|Reported subsequent to the initiation of treatment
11143560|NCT01835015|EG005|Reported Event|Pretreatment|Reported prior to the initiation of study treatment
11143561|NCT01835132|BG000|Baseline|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
11143562|NCT01835132|FG000|Participant Flow|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
11143563|NCT01835132|OG000|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
11143564|NCT01835132|EG000|Reported Event|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
11143565|NCT01835158|BG000|Baseline|Arm I (Cabozantinib-s-malate)|Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
11143566|NCT01835158|BG001|Baseline|Arm II (Sunitinib Malate)|Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
11143567|NCT01835158|BG002|Baseline|Total|Total of all reporting groups
11143568|NCT01835158|FG000|Participant Flow|Arm I (Cabozantinib-s-malate)|Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
11143569|NCT01835158|FG001|Participant Flow|Arm II (Sunitinib Malate)|Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
11143570|NCT01835158|OG000|Outcome|Arm I (Cabozantinib-s-malate)|Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
11143571|NCT01835158|OG001|Outcome|Arm II (Sunitinib Malate)|Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
11143572|NCT01835158|EG000|Reported Event|Arm I (Cabozantinib-s-malate)|Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
11143573|NCT01835158|EG001|Reported Event|Arm II (Sunitinib Malate)|Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
11143574|NCT01835223|BG000|Baseline|Treatment (Tivozanib 1mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tivozanib: Given PO"
11143575|NCT01835223|BG001|Baseline|Treatment (Tivozanib 1.5mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tivozanib: Given PO"
11143576|NCT01835223|BG002|Baseline|Total|Total of all reporting groups
11143577|NCT01835223|FG000|Participant Flow|Treatment (Tivozanib 1mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tivozanib: Given PO"
11143578|NCT01835223|FG001|Participant Flow|Treatment (Tivozanib 1.5mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11143579|NCT01835223|OG000|Outcome|Treatment (Tivozanib 1mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tivozanib: Given PO"
11009439|NCT01101997|BG000|Baseline|Zeltiq System Treatment Group|The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat.
11143580|NCT01835223|OG001|Outcome|Treatment (Tivozanib 1.5mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tivozanib: Given PO"
11143581|NCT01835223|OG000|Outcome|Treatment (Tivozanib - 1 mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tivozanib (1mg): Given PO"
11143582|NCT01835223|OG001|Outcome|Treatment (Tivozanib - 1.5 mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tivozanib (1.5mg): Given PO"
11143583|NCT01835223|EG000|Reported Event|Treatment (Tivozanib 1mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tivozanib: Given PO"
11143584|NCT01835223|EG001|Reported Event|Treatment (Tivozanib 1.5mg)|"Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tivozanib: Given PO"
11143585|NCT01835262|BG000|Baseline|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
11143586|NCT01835262|BG001|Baseline|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
11143587|NCT01835262|BG002|Baseline|Total|Total of all reporting groups
11143588|NCT01835262|FG000|Participant Flow|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
11143589|NCT01835262|FG001|Participant Flow|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
11143590|NCT01835262|OG000|Outcome|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
11143591|NCT01835262|OG001|Outcome|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
11143592|NCT01835262|EG000|Reported Event|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
11143593|NCT01835262|EG001|Reported Event|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
11143594|NCT01835379|BG000|Baseline|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
11143595|NCT01835379|BG001|Baseline|Standard|"Standard Care~Standard Care as chosen by the Investigator"
11143596|NCT01835379|BG002|Baseline|Total|Total of all reporting groups
11143597|NCT01835379|FG000|Participant Flow|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
11143598|NCT01835379|FG001|Participant Flow|Standard|"Standard Care~Standard Care as chosen by the Investigator"
11143599|NCT01835379|OG000|Outcome|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
11143600|NCT01835379|OG001|Outcome|Standard|"Standard Care~Standard Care as chosen by the Investigator"
11143601|NCT01835379|EG000|Reported Event|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
11143602|NCT01835379|EG001|Reported Event|Standard|"Standard Care~Standard Care as chosen by the Investigator"
11143603|NCT01835431|BG000|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
11143604|NCT01835431|BG001|Baseline|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
10879732|NCT00459381|BG000|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
10879733|NCT00459381|FG000|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
10879734|NCT00459381|OG000|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
10879735|NCT00459381|EG000|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
10879736|NCT00459537|BG000|Baseline|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
11143605|NCT01835431|BG002|Baseline|Total|Total of all reporting groups
11143606|NCT01835431|FG000|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
10879737|NCT00459537|BG001|Baseline|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
11143607|NCT01835431|FG001|Participant Flow|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
11143608|NCT01835431|OG000|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
11143609|NCT01835431|OG001|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
11143610|NCT01835431|EG000|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
11143611|NCT01835431|EG001|Reported Event|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
11143612|NCT01835470|BG000|Baseline|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
11143613|NCT01835470|FG000|Participant Flow|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
11143614|NCT01835470|OG000|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
10879738|NCT00459537|BG002|Baseline|Total|Total of all reporting groups
10879739|NCT00459537|FG000|Participant Flow|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
10879740|NCT00459537|FG001|Participant Flow|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
10879741|NCT00459537|OG000|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
10879742|NCT00459537|OG001|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
10879743|NCT00459537|EG000|Reported Event|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
10879744|NCT00459537|EG001|Reported Event|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
10879745|NCT00459667|BG000|Baseline|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
10879746|NCT00459667|BG001|Baseline|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
11143615|NCT01835470|OG000|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
11143616|NCT01835470|EG000|Reported Event|IV ABATACEPT|
11143617|NCT01835496|BG000|Baseline|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
11143618|NCT01835496|FG000|Participant Flow|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
11143619|NCT01835496|OG000|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
11143620|NCT01835496|EG000|Reported Event|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
11143621|NCT01835548|BG000|Baseline|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
11143622|NCT01835548|BG001|Baseline|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
11143623|NCT01835548|BG002|Baseline|Total|Total of all reporting groups
11143624|NCT01835548|FG000|Participant Flow|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
11143625|NCT01835548|FG001|Participant Flow|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
11143626|NCT01835548|FG002|Participant Flow|All Participants|All participants in the study went through the screening/washout period, then received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants stayed on that dose for 1 week during the dose stabilization period before randomization into the double-blind treatment period.
11143627|NCT01835548|OG000|Outcome|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
11143628|NCT01835548|OG001|Outcome|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
11143629|NCT01835548|OG000|Outcome|All Participants|Includes all participants from experimental and placebo comparator arms.
11143630|NCT01835548|OG001|Outcome|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
11143631|NCT01835548|OG000|Outcome|Dose Optimization/Stabilization Phase|All participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period).
11143632|NCT01835548|OG001|Outcome|Double-Blind Phase: Placebo|At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
11143633|NCT01835548|OG002|Outcome|Double-Blind Phase: NT0102|At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
11143634|NCT01835548|EG000|Reported Event|Dose Optimization/Stabilization Phase|All participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period).
11143635|NCT01835548|EG001|Reported Event|Double-Blind Phase: Placebo|At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
11143636|NCT01835548|EG002|Reported Event|Double-Blind Phase: NT0102|At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
11143637|NCT01835587|BG000|Baseline|CC-486 200 mg Days 1-7 (Cohort 1)|Participants received CC-486 200 mg by mouth (PO) once daily (QD) on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event (AE), disease recurrence or relapse, progressive disease (PD), development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death
11143638|NCT01835587|BG001|Baseline|CC-486 300 mg Days 1-7 (Cohort 2)|Participants received CC-486 300 mg by mouth once daily on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease, withdrawal of consent, lost to follow-up, protocol violation or death.
11143639|NCT01835587|BG002|Baseline|CC-486 150 mg Days 1-14 (Cohort 3A)|Participants received CC-486 150 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease, withdrawal of consent, lost to follow-up, protocol violation or death.
11143640|NCT01835587|BG003|Baseline|CC-486 200 mg Days 1-14 (Cohort 3)|Participants received CC-486 200 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death.
11143641|NCT01835587|BG004|Baseline|Total|Total of all reporting groups
11143642|NCT01835587|FG000|Participant Flow|CC-486 200 mg Days 1-7 (Cohort 1)|Participants received CC-486 200 mg by mouth (PO) once daily (QD) on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event (AE), disease recurrence or relapse, progressive disease (PD), development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death
11143643|NCT01835587|FG001|Participant Flow|CC-486 300 mg Days 1-7 (Cohort 2)|Participants received CC-486 300 mg by mouth once daily on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease, withdrawal of consent, lost to follow-up, protocol violation or death.
11143644|NCT01835587|FG002|Participant Flow|CC-486 150 mg Days 1-14 (Cohort 3A)|Participants received CC-486 150 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease, withdrawal of consent, lost to follow-up, protocol violation or death.
11143645|NCT01835587|FG003|Participant Flow|CC-486 200 mg Days 1-14 (Cohort 3)|Participants received CC-486 200 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death.
11143646|NCT01835587|OG000|Outcome|CC-486 200 mg Days 1-7|Participants received CC-486 200 mg by mouth (PO) once daily (QD) on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event (AE), disease recurrence or relapse, progressive disease (PD), development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death
11143647|NCT01835587|OG001|Outcome|CC-486 300 mg Days 1-7|Participants received CC-486 300 mg by mouth once daily on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease, withdrawal of consent, lost to follow-up, protocol violation or death.
11143648|NCT01835587|OG002|Outcome|CC-486 150 mg Days 1-14|Participants received CC-486 150 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease, withdrawal of consent, lost to follow-up, protocol violation or death.
11143649|NCT01835587|OG003|Outcome|CC-486 200 mg Days 1-14|Participants received CC-486 200 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death.
11143650|NCT01835587|OG000|Outcome|CC-486 200 mg Days 1-7|Participants received CC-486 200 mg by mouth (PO) once daily (QD) on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced, adverse event (AE), disease recurrence or relapse, progressive disease (PD), development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death
11143651|NCT01835587|OG003|Outcome|CC-486 200 mg Days 1-14|Participants received CC-486 200 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced, adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death.
11143652|NCT01835587|OG000|Outcome|CC-486 200 mg Days 1-7 and Days 1-14|Pharmacokinetic data from participants who received CC-486 200 mg by mouth daily were combined because the wash-out period between the PK sample collection and previous CC-486 dose was greater than 7-fold the half-life elimination of the drug, and CC 486 does not accumulate following multiple administrations.
11143653|NCT01835587|OG000|Outcome|CC-486 200 mg Days 1-7 and Days 1-14-day|Pharmacokinetic data from participants who received CC-486 200 mg by mouth daily were combined because the wash-out period between the PK sample collection and previous CC-486 dose was greater than 7-fold the half-life elimination of the drug, and CC 486 does not accumulate following multiple administrations.
11143654|NCT01835587|OG000|Outcome|CC-486 200 mg Days 1-7 and Day 1-14|Pharmacokinetic data from participants who received CC-486 200 mg by mouth daily were combined because the wash-out period between the PK sample collection and previous CC-486 dose was greater than 7-fold the half-life elimination of the drug, and CC 486 does not accumulate following multiple administrations.
11143655|NCT01835587|OG000|Outcome|CC-486 200 mg Days 1-7 (Cohort 1)|Participants received CC-486 200 mg by mouth (PO) once daily (QD) on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced, adverse event (AE), disease recurrence or relapse, progressive disease (PD), development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death
11143656|NCT01835587|OG003|Outcome|CC-486 200 mg Days 1-14 (Cohort 3)|Participants received CC-486 200 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced, adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death.
11143657|NCT01835587|EG000|Reported Event|CC-486 200 mg Days 1-7 (Cohort 1)|Participants received CC-486 200 mg by mouth (PO) once daily (QD) on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event (AE), disease recurrence or relapse, progressive disease (PD), development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death
11143658|NCT01835587|EG001|Reported Event|CC-486 300 mg Days 1-7 (Cohort 2)|Participants received CC-486 300 mg by mouth once daily on Days 1 to 7 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease, withdrawal of consent, lost to follow-up, protocol violation or death.
11143659|NCT01835587|EG002|Reported Event|CC-486 150 mg Days 1-14 (Cohort 3A)|Participants received CC-486 150 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease, withdrawal of consent, lost to follow-up, protocol violation or death.
11143660|NCT01835587|EG003|Reported Event|CC-486 200 mg Days 1-14 (Cohort 3)|Participants received CC-486 200 mg by mouth once daily on Days 1 to 14 of each 28-day cycle for a maximum duration of 12 months or until they experienced an adverse event, disease recurrence or relapse, progressive disease, development of Grade III/IV acute graft versus host disease (GVHD), withdrawal of consent, lost to follow-up, protocol violation or death.
11143661|NCT01835626|BG000|Baseline|Vismodegib and Radiation Therapy|150mg Vismodegib will be taken once a day, daily. Radiation therapy will be started after the patient has completed taking vismodegib for 12 weeks. The patient will take daily vismodegib through the completion of radiation therapy. The patient will receive radiation once a day, Monday through Friday, for 7 weeks. Each radiation treatment may take up to 30 minutes. After 12 weeks, they will be evaluated again to make sure they are still eligible to participate in the study. If they are eligible to continue, they will continue taking vismodeib daily as before for another 7 weeks while they receive radiation therapy.
11143662|NCT01835626|FG000|Participant Flow|Vismodegib and Radiation Therapy|150mg Vismodegib will be taken once a day, daily. Radiation therapy will be started after the patient has completed taking vismodegib for 12 weeks. The patient will take daily vismodegib through the completion of radiation therapy. The patient will receive radiation once a day, Monday through Friday, for 7 weeks. Each radiation treatment may take up to 30 minutes. After 12 weeks, they will be evaluated again to make sure they are still eligible to participate in the study. If they are eligible to continue, they will continue taking vismodeib daily as before for another 7 weeks while they receive radiation therapy.
11143663|NCT01835626|OG000|Outcome|Vismodegib and Radiation Therapy|150mg Vismodegib will be taken once a day, daily. Radiation therapy will be started after the patient has completed taking vismodegib for 12 weeks. The patient will take daily vismodegib through the completion of radiation therapy. The patient will receive radiation once a day, Monday through Friday, for 7 weeks. Each radiation treatment may take up to 30 minutes. After 12 weeks, they will be evaluated again to make sure they are still eligible to participate in the study. If they are eligible to continue, they will continue taking vismodeib daily as before for another 7 weeks while they receive radiation therapy.
11143664|NCT01835626|EG000|Reported Event|Vismodegib and Radiation Therapy|150mg Vismodegib will be taken once a day, daily. Radiation therapy will be started after the patient has completed taking vismodegib for 12 weeks. The patient will take daily vismodegib through the completion of radiation therapy. The patient will receive radiation once a day, Monday through Friday, for 7 weeks. Each radiation treatment may take up to 30 minutes. After 12 weeks, they will be evaluated again to make sure they are still eligible to participate in the study. If they are eligible to continue, they will continue taking vismodeib daily as before for another 7 weeks while they receive radiation therapy.
11143665|NCT01835743|BG000|Baseline|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11143666|NCT01835743|BG001|Baseline|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11143667|NCT01835743|BG002|Baseline|Total|Total of all reporting groups
11143668|NCT01835743|FG000|Participant Flow|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11143669|NCT01835743|FG001|Participant Flow|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11143670|NCT01835743|OG000|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11143671|NCT01835743|OG001|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11143672|NCT01835743|EG000|Reported Event|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11143673|NCT01835743|EG001|Reported Event|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11143674|NCT01835756|BG000|Baseline|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
11143675|NCT01835756|BG001|Baseline|Placebo Laser|The Placebo Laser has the same appearance and treatment application as the Erchonia MLS but does not emit any therapeutic light.
11143676|NCT01835756|BG002|Baseline|Total|Total of all reporting groups
11143677|NCT01835756|FG000|Participant Flow|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. It is applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
11143678|NCT01835756|FG001|Participant Flow|Placebo Laser|The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.
11143679|NCT01835756|OG000|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light, applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
11009440|NCT01101997|FG000|Participant Flow|Zeltiq System Treatment Group|The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat.
11143680|NCT01835756|OG001|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the active Erchonia MLS but does not emit any therapeutic light.
11143681|NCT01835756|OG000|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
11143682|NCT01835756|OG001|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
11143683|NCT01835756|EG000|Reported Event|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
11143684|NCT01835756|EG001|Reported Event|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
11143685|NCT01835899|BG000|Baseline|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
11143686|NCT01835899|BG001|Baseline|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
11143687|NCT01835899|BG002|Baseline|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
11143688|NCT01835899|BG003|Baseline|Total|Total of all reporting groups
11143689|NCT01835899|FG000|Participant Flow|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
11143690|NCT01835899|FG001|Participant Flow|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
11143691|NCT01835899|FG002|Participant Flow|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
11143692|NCT01835899|OG000|Outcome|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
11143693|NCT01835899|OG001|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
11143694|NCT01835899|OG002|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
11143695|NCT01835899|OG000|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
11143696|NCT01835899|OG001|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
11143697|NCT01835899|EG000|Reported Event|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
11143698|NCT01835899|EG001|Reported Event|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
11143699|NCT01835899|EG002|Reported Event|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
11143700|NCT01835912|BG000|Baseline|All Study Participants|"Acute: dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)~Acute Placebo: 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)~Chronic: 3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)~Chronic Placebo: 3 days of 500 milliliters flavoured water and the 4th day 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)"
11143701|NCT01835912|FG000|Participant Flow|All Study Participants|"Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) and their corresponding placebos.~4 arms: Acute, Acute Placebo, Chronic, Chronic Placebo~Acute: 0.5 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water~Acute Placebo: 500 milliliters of flavoured water~Chronic: 3 days of 0.1 g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water~Chronic Placebo: 3 days of 500 millilitres of flavoured water and 4th day 500 millilitres of flavoured water"
11143702|NCT01835912|OG000|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
11143703|NCT01835912|OG001|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
11143704|NCT01835912|OG002|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
11143705|NCT01835912|OG003|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
11143706|NCT01835912|EG000|Reported Event|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
11143707|NCT01835912|EG001|Reported Event|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
11143708|NCT01835912|EG002|Reported Event|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
11143709|NCT01835912|EG003|Reported Event|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
11143710|NCT01836029|BG000|Baseline|Chemotherapy and Cetuximab Plus VTX-2337|VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
11143711|NCT01836029|BG001|Baseline|Chemotherapy and Cetuximab Plus Placebo|Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
11143712|NCT01836029|BG002|Baseline|Total|Total of all reporting groups
11143713|NCT01836029|FG000|Participant Flow|Chemotherapy and Cetuximab Plus VTX-2337|VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
11143714|NCT01836029|FG001|Participant Flow|Chemotherapy and Cetuximab Plus Placebo|Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
11143715|NCT01836029|OG000|Outcome|Chemotherapy and Cetuximab Plus VTX-2337|VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
11149867|NCT01874145|OG001|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
11143716|NCT01836029|OG001|Outcome|Chemotherapy and Cetuximab Plus Placebo|Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
11149868|NCT01874145|OG000|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
11009441|NCT01101997|OG000|Outcome|Zeltiq System Treatment Group|The per protocol population consists of all evaluable subjects treated with the Zeltiq System for the reduction of abdominal fat and whose weight change was within 5 pounds of baseline weight.
11009442|NCT01101997|OG000|Outcome|Experimental: Abdomen Treatment Group|"All subjects were treated on the abdomen with the CoolSculpting system.~The Zeltiq System: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
11009443|NCT01101997|OG000|Outcome|Zeltiq System Treatment Group|The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat.
11009444|NCT01101997|EG000|Reported Event|Zeltiq System Treatment Group|The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat.
11009445|NCT01102218|BG000|Baseline|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
11009446|NCT01102218|BG001|Baseline|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
11009447|NCT01102218|BG002|Baseline|Total|Total of all reporting groups
11009448|NCT01102218|FG000|Participant Flow|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
11009449|NCT01102218|FG001|Participant Flow|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
11009450|NCT01102218|OG000|Outcome|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
11009451|NCT01102218|OG001|Outcome|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
11009452|NCT01102218|EG000|Reported Event|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
11009453|NCT01102218|EG001|Reported Event|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
11009454|NCT01102231|BG000|Baseline|Chemoradiotherapy + Cetuximab|"Chemoradiotherapy~Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)~ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes~Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)"
11009455|NCT01102231|FG000|Participant Flow|Chemoradiotherapy + Cetuximab|"Chemotherapy + cetuximab + radiotherapy~Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)~ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes~Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)"
11009456|NCT01102231|OG000|Outcome|Chemoradiotherapy + Cetuximab|"Chemoradiotherapy~Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)~ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes~Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)"
11009457|NCT01102231|OG000|Outcome|Chemoradiotherapy + Cetuximab|"Chemotherapy + cetuximab + radiotherapy~Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)~ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes~Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)"
11009458|NCT01102231|EG000|Reported Event|Chemoradiotherapy + Cetuximab|"Chemotherapy + cetuximab + radiotherapy~Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)~ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes~Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)"
11009459|NCT01102257|BG000|Baseline|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
11009460|NCT01102257|BG001|Baseline|Olive Oil|5 Gel Capsules of olive oil taken orally daily
11009461|NCT01102257|BG002|Baseline|Total|Total of all reporting groups
11009462|NCT01102257|FG000|Participant Flow|Omega-3 Supplement|5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA
11009463|NCT01102257|FG001|Participant Flow|Olive Oil|5 Gel Capsules of olive oil to be taken orally daily
11009464|NCT01102257|OG000|Outcome|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
11009465|NCT01102257|OG001|Outcome|Olive Oil|5 Gel Capsules of olive oil taken orally daily
11009466|NCT01102257|EG000|Reported Event|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
11009467|NCT01102257|EG001|Reported Event|Olive Oil|5 Gel Capsules of olive oil taken orally daily
11009468|NCT01102270|BG000|Baseline|All Study Participants|all study participants who received all interventions
11009469|NCT01102270|FG000|Participant Flow|Eszopiclone First, Then Sugar Pill|Eszopiclone : 3mg tablet once prior to sleep followed by sugar pill (placebo) 1 week later
11009470|NCT01102270|FG001|Participant Flow|Sugar Pill First, Then Eszopiclone|Placebo : 1 placebo capsule prior to sleep then 3mg eszopiclone 1 week later
11009471|NCT01102270|OG000|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
11009472|NCT01102270|OG001|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
11009473|NCT01102270|EG000|Reported Event|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
11009474|NCT01102270|EG001|Reported Event|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
11143717|NCT01836029|EG000|Reported Event|Chemotherapy and Cetuximab Plus VTX-2337|VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
11143718|NCT01836029|EG001|Reported Event|Chemotherapy and Cetuximab Plus Placebo|Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
11143719|NCT01836042|BG000|Baseline|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
11143720|NCT01836042|BG001|Baseline|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
11143721|NCT01836042|BG002|Baseline|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
11143722|NCT01836042|BG003|Baseline|Total|Total of all reporting groups
11143723|NCT01836042|FG000|Participant Flow|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
11143724|NCT01836042|FG001|Participant Flow|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
11143725|NCT01836042|FG002|Participant Flow|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
11143726|NCT01836042|OG000|Outcome|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
11143727|NCT01836042|OG001|Outcome|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
11143728|NCT01836042|OG002|Outcome|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
11143729|NCT01836042|EG000|Reported Event|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
11143730|NCT01836042|EG001|Reported Event|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
11143731|NCT01836042|EG002|Reported Event|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
11143732|NCT01836133|BG000|Baseline|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
11143733|NCT01836133|FG000|Participant Flow|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
11143734|NCT01836133|OG000|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
11143735|NCT01836133|EG000|Reported Event|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
11143736|NCT01836185|BG000|Baseline|Evacetrapib (Healthy)|Group 1: 130 milligrams (mg) evacetrapib administered once, orally as a tablet to participants with normal hepatic function
11143737|NCT01836185|BG001|Baseline|Evacetrapib (Hepatic, Mild)|Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment
11143738|NCT01836185|BG002|Baseline|Evacetrapib (Hepatic, Moderate)|Group 3: 130 mg evacetrapib administered once, orally as a tablet to participants with moderate hepatic impairment
11143739|NCT01836185|BG003|Baseline|Evacetrapib (Hepatic, Severe)|Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment
11143740|NCT01836185|BG004|Baseline|Total|Total of all reporting groups
11143741|NCT01836185|FG000|Participant Flow|Evacetrapib (Healthy)|Group 1: 130 milligrams (mg) evacetrapib administered once, orally as a tablet to participants with normal hepatic function
11143742|NCT01836185|FG001|Participant Flow|Evacetrapib (Hepatic, Mild)|Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment
11143743|NCT01836185|FG002|Participant Flow|Evacetrapib (Hepatic, Moderate)|Group 3: 130 mg evacetrapib administered once, orally as a tablet to participants with moderate hepatic impairment
11143744|NCT01836185|FG003|Participant Flow|Evacetrapib (Hepatic, Severe)|Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment
11143745|NCT01836185|OG000|Outcome|Evacetrapib (Healthy)|Group 1: 130 mg evacetrapib administered once, orally as a tablet to participants with normal hepatic function
11143746|NCT01836185|OG001|Outcome|Evacetrapib (Hepatic, Mild)|Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment
11143747|NCT01836185|OG002|Outcome|Evacetrapib (Hepatic, Moderate)|Group 3: 130 mg evacetrapib administered once, orally as a tablet to participants with moderate hepatic impairment
11143748|NCT01836185|OG003|Outcome|Evacetrapib (Hepatic, Severe)|Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment
11143749|NCT01836185|EG000|Reported Event|Evacetrapib (Healthy)|Group 1: 130 mg evacetrapib administered once, orally as a tablet to participants with normal hepatic function
11143750|NCT01836185|EG001|Reported Event|Evacetrapib (Hepatic, Mild)|Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment
11143751|NCT01836185|EG002|Reported Event|Evacetrapib (Hepatic, Moderate)|Group 3: 130 mg evacetrapib administered once, orally, as a tablet to participants with moderate hepatic impairment
11143752|NCT01836185|EG003|Reported Event|Evacetrapib (Hepatic, Severe)|Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment
11149869|NCT01874145|OG001|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
11143753|NCT01836198|BG000|Baseline|Part A: LY2409021+Gemfibrozil (Cohort 1)|"Part A, Period 1. Participants received a single 20-milligram (mg) oral dose of LY2409021 on Day 1.~Part A, Period 2. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants also received a single 20-mg oral dose of LY2409021 on Day 4. There was a washout period from Day 22 through Day 28."
11143754|NCT01836198|BG001|Baseline|Part A: LY2409021+Ketoconazole (Cohort 2)|"Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1.~Part A, Period 2. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. There was a washout period from Day 22 through Day 28."
11143755|NCT01836198|BG002|Baseline|Total|Total of all reporting groups
11143756|NCT01836198|FG000|Participant Flow|Part A: LY2409021+Gemfibrozil (Cohort 1)|"Part A, Period 1. Participants received a single 20-milligram (mg) oral dose of LY2409021 on Day 1.~Part A, Period 2. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants also received a single 20-mg oral dose of LY2409021 on Day 4. There was a washout period from Day 22 through Day 28."
11143757|NCT01836198|FG001|Participant Flow|Part A: LY2409021+Ketoconazole (Cohort 2)|"Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1.~Part A, Period 2. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. There was a washout period from Day 22 through Day 28."
11143758|NCT01836198|FG002|Participant Flow|Part B: LY2409021+Clarithromycin|Part B. Participants received a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.
11143759|NCT01836198|OG000|Outcome|LY2409021 Only (Part A, Cohort 1)|Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1.
11143760|NCT01836198|OG001|Outcome|LY2409021+Gemfibrozil (Part A, Cohort 1)|Part A, Period 2. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants also received a single 20-mg oral dose of LY2409021 on Day 4.
11143761|NCT01836198|OG002|Outcome|LY2409021 Only (Part A, Cohort 2)|Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1.
11143762|NCT01836198|OG003|Outcome|LY2409021+Ketoconazole (Part A, Cohort 2)|Part A, Period 2. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.
11143763|NCT01836198|OG004|Outcome|LY2409021 Only (Part B Participants, Data From Part A)|"LY2409021 alone data are from Part A for the participants who participated in Part B.~Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1."
11143764|NCT01836198|OG005|Outcome|LY2409021+Clarithromycin (Part B)|Part B. Participants received a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.
11143765|NCT01836198|EG000|Reported Event|LY2409021 Only (Part A, Cohort 1)|Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1.
11143766|NCT01836198|EG001|Reported Event|Gemfibrozil Only (Part A, Cohort 1)|Part A, Period 2, Days -1 to 3. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-3.
11143767|NCT01836198|EG002|Reported Event|LY2409021+Gemfibrozil (Part A, Cohort 1)|Part A, Period 2, Day 4 to end of Period 2. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 4-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants also received a single 20-mg oral dose of LY2409021 on Day 4.
11143768|NCT01836198|EG003|Reported Event|LY2409021 Only (Part A, Cohort 2)|Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1.
11143769|NCT01836198|EG004|Reported Event|Ketoconazole Only (Part A, Cohort 2)|Part A, Period 2, Days -1 to 3. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 1-3.
11143770|NCT01836198|EG005|Reported Event|LY2409021+Ketoconazole (Part A, Cohort 2)|Part A, Period 2, Day 4 to end of Period 2. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 4-21 and a single 20-mg oral dose of LY2409021 on Day 4.
11143771|NCT01836198|EG006|Reported Event|Clarithromycin Only (Part B)|Part B, Days -1 to 3. Participants received a twice-daily 500-mg oral dose of clarithromycin on Days 1-3.
11143772|NCT01836198|EG007|Reported Event|LY2409021+Clarithromycin (Part B)|Part B, Day 4 to end of Part B. Participants received a twice-daily 500-mg oral dose of clarithromycin on Days 4-21 and a single 20-mg oral dose of LY2409021 on Day 4.
11143773|NCT01836276|BG000|Baseline|African American|12 weeks of varenicline and 6 counseling sessions.
11143774|NCT01836276|BG001|Baseline|White|12 weeks of varenicline and 6 counseling sessions.
11143775|NCT01836276|BG002|Baseline|Total|Total of all reporting groups
11143776|NCT01836276|FG000|Participant Flow|African American Smokers|"African Americans smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.~Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines"
11143777|NCT01836276|FG001|Participant Flow|White Smokers|"White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.~Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines"
11143778|NCT01836276|OG000|Outcome|African American (AA) Smokers|"AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.~Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines"
11143779|NCT01836276|OG001|Outcome|White Smokers|"White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.~Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines"
11143780|NCT01836276|EG000|Reported Event|African American|Varenicline treatment began at Week 0 and continued through Week 12. Adverse events were monitored through week 16.
11143781|NCT01836276|EG001|Reported Event|White|Varenicline treatment began at Week 0 and continued through Week 12. Adverse events were monitored through week 16.
11149870|NCT01874145|EG000|Reported Event|GA 20 mg/mL QD (Core)|Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
11143782|NCT01836445|BG000|Baseline|Keep It Up! Intervention|"The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete.~Keep It Up!"
11143783|NCT01836445|BG001|Baseline|HIV Knowledge Control|"The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days).~HIV Knowledge Control"
11348796|NCT04147611|EG001|Reported Event|Normal Hearing Controls|"The normal hearing controls will be limited to 15 adults.~Participants will be tested separately on the six following conditions:~Unaided~Unilateral hearing aid with contralateral plug.~Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)~Bone Conduction Device (BAHA) only~BAHA + Wireless Audio-Streaming Accessory~BAHA + Digital Adaptive RM System~BAHA: Participant's pediatric bone conduction hearing device.~Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.~Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.~Hearing Aid: Participant's unilateral hearing aid with contralateral plug."
11348797|NCT04147442|BG000|Baseline|Music Program Fine-tuned|"The fine-tuned program and the standard program will be compared within the same instrument as a hearing aid can have up to 4 different listening programs in it.~Hearing aid with fine-tuned program: A digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fine-tuned for their specific music playing."
11348798|NCT04147442|FG000|Participant Flow|Music Program Fine-tuned and Standard|"The fine-tuned program and the standard program will be compared within the same instrument as a hearing aid can have up to 4 different listening programs in it.~The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings."
11143784|NCT01836445|BG002|Baseline|Total|Total of all reporting groups
11143785|NCT01836445|FG000|Participant Flow|Keep It Up! Intervention|"The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete.~Keep It Up!"
11143786|NCT01836445|FG001|Participant Flow|HIV Knowledge Control|"The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days).~HIV Knowledge Control"
11143787|NCT01836445|OG000|Outcome|Keep It Up! Intervention|"The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete.~Keep It Up!"
11143788|NCT01836445|OG001|Outcome|HIV Knowledge Control|"The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days).~HIV Knowledge Control"
11348799|NCT04147442|OG000|Outcome|Music Program Fine-tuned and Standard|"The fine-tuned program and the standard program will be compared within the same instrument as a hearing aid can have up to 4 different listening programs in it.~The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings."
11143789|NCT01836445|EG000|Reported Event|Keep It Up! Intervention|"The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete.~Keep It Up!"
11143790|NCT01836445|EG001|Reported Event|HIV Knowledge Control|"The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days).~HIV Knowledge Control"
11143791|NCT01836458|BG000|Baseline|Dose 1: 30 mg|Single dose of KAE609 30 mg
11143792|NCT01836458|BG001|Baseline|Dose 2: 20 mg|Single dose of KAE609 20 mg
11143793|NCT01836458|BG002|Baseline|Dose 3: 10 mg|Single dose of KAE609 10 mg
11143794|NCT01836458|BG003|Baseline|Dose 4: 15 mg|Single dose of KAE609 15 mg
11143795|NCT01836458|BG004|Baseline|Total|Total of all reporting groups
11143796|NCT01836458|FG000|Participant Flow|Dose 1: 30 mg|Single dose of KAE609 30 mg
11143797|NCT01836458|FG001|Participant Flow|Dose 2: 20 mg|Single dose of KAE609 20 mg
11143798|NCT01836458|FG002|Participant Flow|Dose 3: 10 mg|Single dose of KAE609 10 mg
11143799|NCT01836458|FG003|Participant Flow|Dose 4: 15 mg|Single dose of KAE609 15 mg
11143800|NCT01836458|OG000|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
11143801|NCT01836458|OG001|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
11143802|NCT01836458|OG002|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
11348800|NCT04147442|OG000|Outcome|Music Program Fine-tuned|"The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings.~They will perform the test with the fine-tuned program."
11143803|NCT01836458|OG003|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
11143804|NCT01836458|EG000|Reported Event|Dose 1: 30mg|Single dose of KAE609 30 mg
11143805|NCT01836458|EG001|Reported Event|Dose 2: 20mg|Single dose of KAE609 20 mg
11143806|NCT01836458|EG002|Reported Event|Dose 3: 10mg|Single dose of KAE609 10 mg
11143807|NCT01836458|EG003|Reported Event|Dose 4: 15mg|Single dose of KAE609 15 mg
11143808|NCT01836471|BG000|Baseline|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
11143809|NCT01836471|BG001|Baseline|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
11143810|NCT01836471|BG002|Baseline|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143811|NCT01836471|BG003|Baseline|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143812|NCT01836471|BG004|Baseline|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143813|NCT01836471|BG005|Baseline|Total|Total of all reporting groups
11143814|NCT01836471|FG000|Participant Flow|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
11143815|NCT01836471|FG001|Participant Flow|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
11143816|NCT01836471|FG002|Participant Flow|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143817|NCT01836471|FG003|Participant Flow|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143818|NCT01836471|FG004|Participant Flow|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143819|NCT01836471|OG000|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
11143820|NCT01836471|OG001|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
11143821|NCT01836471|OG000|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143822|NCT01836471|OG001|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143823|NCT01836471|OG002|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143824|NCT01836471|OG002|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143825|NCT01836471|OG003|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143826|NCT01836471|OG004|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
11143827|NCT01836471|EG000|Reported Event|QAW039 450 mg qd|QAW039 450 mg qd
11143828|NCT01836471|EG001|Reported Event|Fluticasone 150 mcg Bid|Fluticasone 150 mcg bid
11143829|NCT01836471|EG002|Reported Event|Placebo|Placebo
11143830|NCT01836523|BG000|Baseline|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
11143831|NCT01836523|BG001|Baseline|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
11143832|NCT01836523|BG002|Baseline|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
11143833|NCT01836523|BG003|Baseline|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
11143834|NCT01836523|BG004|Baseline|Total|Total of all reporting groups
11143835|NCT01836523|FG000|Participant Flow|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
11143836|NCT01836523|FG001|Participant Flow|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
11143837|NCT01836523|FG002|Participant Flow|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
11143838|NCT01836523|FG003|Participant Flow|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
11143839|NCT01836523|OG000|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
11143840|NCT01836523|OG001|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
11143841|NCT01836523|OG002|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
11143842|NCT01836523|OG003|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
11143843|NCT01836523|EG000|Reported Event|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
10879747|NCT00459667|BG002|Baseline|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
11143844|NCT01836523|EG001|Reported Event|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
11143845|NCT01836523|EG002|Reported Event|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
11143846|NCT01836523|EG003|Reported Event|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
11143847|NCT01836549|BG000|Baseline|Molecular Biology Stratum-A|This is the Molecular Biology arm for Medulloblastoma/PNET Patients
11143848|NCT01836549|BG001|Baseline|Molecular Biology Stratum-B|This is the Molecular Biology arm for High-Grade Glioma Patients
11143849|NCT01836549|BG002|Baseline|Stratum-A|This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
11143850|NCT01836549|BG003|Baseline|Stratum-B|This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
11143851|NCT01836549|BG004|Baseline|Stratum-C|This is the Phase-II stratum for Recurrent or refractory ependymoma patients
11143852|NCT01836549|BG005|Baseline|Stratum-D|This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
11143853|NCT01836549|BG006|Baseline|Total|Total of all reporting groups
11143854|NCT01836549|FG000|Participant Flow|Molecular Biology Stratum-A|This is the Molecular Biology arm for Medulloblastoma/PNET Patients
11143855|NCT01836549|FG001|Participant Flow|Molecular Biology Stratum-B|This is the Molecular Biology arm for High-Grade Glioma Patients
11143856|NCT01836549|FG002|Participant Flow|Molecular Biology Stratum-C|This is the Molecular Biology arm for Ependymoma Patients
11143857|NCT01836549|FG003|Participant Flow|Stratum-A|This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
11143858|NCT01836549|FG004|Participant Flow|Stratum-B|This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
11143859|NCT01836549|FG005|Participant Flow|Stratum-C|This is the Phase-II stratum for Recurrent or refractory ependymoma patients
11143860|NCT01836549|FG006|Participant Flow|Stratum-D|This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
11143861|NCT01836549|OG000|Outcome|Molecular Biology Study|"Molecular Biology Phase: Patients will receive one infusion of imetelstat prior to surgery. Surgery will take place 12-24 hours after the infusion of imetelstat. Patients will continue to receive therapy on the same schedule as the Phase II patients starting 14-21 days after surgery.~Phase II: Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~imetelstat sodium: Given IV"
11143862|NCT01836549|OG000|Outcome|Stratum-A|This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
11143863|NCT01836549|OG001|Outcome|Stratum-B|This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
11143864|NCT01836549|OG002|Outcome|Stratum-C|This is the Phase-II stratum for Recurrent or refractory ependymoma patients
11143865|NCT01836549|OG003|Outcome|Stratum-D|This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine glioma patients
11143866|NCT01836549|OG003|Outcome|Stratum-D|This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
11143867|NCT01836549|OG000|Outcome|Stratum-C|This objective is for HGG and ependymoma patients only.
11143868|NCT01836549|OG000|Outcome|Treatment (Imetelstat Sodium)|"Molecular Biology Phase: Patients will receive one infusion of imetelstat prior to surgery. Surgery will take place 12-24 hours after the infusion of imetelstat. Patients will continue to receive therapy on the same schedule as the Phase II patients starting 14-21 days after surgery.~Phase II: Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~imetelstat sodium: Given IV"
11143869|NCT01836549|EG000|Reported Event|Molecular Study-A|Molecular Study arm for Recurrent or Refractory Medulloblastoma/PNET Patients
11143870|NCT01836549|EG001|Reported Event|Molecular Study-B|Molecular Study arm for Recurrent or refractory high-grade glioma patients
11143871|NCT01836549|EG002|Reported Event|Stratum-A|This is the Phase-II stratum for Recurrent or Refractory Medulloblastoma/PNET Patients
11143872|NCT01836549|EG003|Reported Event|Stratum-B|This is the Phase-II stratum for Recurrent or refractory high-grade glioma patients
11143873|NCT01836549|EG004|Reported Event|Stratum-C|This is the Phase-II stratum for Recurrent or refractory ependymoma patients
11143874|NCT01836549|EG005|Reported Event|Stratum-D|This is the Phase-II stratum for Recurrent or refractory diffuse intrinsic pontine gliomas (DIPG) patients
11143875|NCT01837069|BG000|Baseline|Treatment|"Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated~Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing~Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing~Atorvastatin: 80mg PO QD at preadmission testing~Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling"
11143876|NCT01837069|BG001|Baseline|Control|Standard of care
11143877|NCT01837069|BG002|Baseline|Total|Total of all reporting groups
11143878|NCT01837069|FG000|Participant Flow|Treatment|"Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated~Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing~Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing~Atorvastatin: 80mg PO QD at preadmission testing~Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling"
11143879|NCT01837069|FG001|Participant Flow|Control|Standard of care
11143880|NCT01837069|OG000|Outcome|Treatment|"Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated~Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing~Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing~Atorvastatin: 80mg PO QD at preadmission testing~Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling"
11143881|NCT01837069|OG001|Outcome|Control|Standard of care
11143882|NCT01837069|EG000|Reported Event|Treatment|"Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated~Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing~Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing~Atorvastatin: 80mg PO QD at preadmission testing~Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling"
11143883|NCT01837069|EG001|Reported Event|Control|Standard of care
11143884|NCT01837524|BG000|Baseline|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
11143885|NCT01837524|BG001|Baseline|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
11143886|NCT01837524|BG002|Baseline|Total|Total of all reporting groups
11143887|NCT01837524|FG000|Participant Flow|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
11143888|NCT01837524|FG001|Participant Flow|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
11143889|NCT01837524|OG000|Outcome|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
11143890|NCT01837524|OG001|Outcome|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
11143891|NCT01837524|EG000|Reported Event|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
11143892|NCT01837524|EG001|Reported Event|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
11143893|NCT01837537|BG000|Baseline|no Treatment|no treatment, prospective observational
11143894|NCT01837537|FG000|Participant Flow|no Treatment|no treatment, prospective observational
11143895|NCT01837537|OG000|Outcome|no Treatment|no treatment, prospective observational
11143896|NCT01837537|EG000|Reported Event|no Treatment|no treatment, prospective observational
11143897|NCT01837550|BG000|Baseline|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
11143898|NCT01837550|BG001|Baseline|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
11143899|NCT01837550|BG002|Baseline|Total|Total of all reporting groups
11143900|NCT01837550|FG000|Participant Flow|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
11143901|NCT01837550|FG001|Participant Flow|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
11143902|NCT01837550|OG000|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
11143903|NCT01837550|OG001|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
11143904|NCT01837550|EG000|Reported Event|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
11143905|NCT01837550|EG001|Reported Event|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
11143906|NCT01837654|BG000|Baseline|Plantarflexion - 2nd Wave|"At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.~Plantarflexion 2nd wave : At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor."
11143907|NCT01837654|BG001|Baseline|Plantarflexion - 3rd Wave|"At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.~Plantarflexion - 3rd wave : At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor."
11143908|NCT01837654|BG002|Baseline|Total|Total of all reporting groups
11143909|NCT01837654|FG000|Participant Flow|Plantarflexion - 2nd Wave of Contraction|"At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.~Plantarflexion 2nd wave : At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor."
11143910|NCT01837654|FG001|Participant Flow|Plantarflexion - 3rd Wave of Contraction|"At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.~Plantarflexion - 3rd wave : At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor."
11143911|NCT01837654|OG000|Outcome|Plantarflexion - 2nd Wave|"At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.~Plantarflexion 2nd wave : At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor."
11143912|NCT01837654|OG001|Outcome|Plantarflexion - 3rd Wave|"At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.~Plantarflexion - 3rd wave : At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor."
11143913|NCT01837654|EG000|Reported Event|Plantarflexion - 2nd Wave|"At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.~Plantarflexion 2nd wave : At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor."
11143914|NCT01837654|EG001|Reported Event|Plantarflexion - 3rd Wave|"At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.~Plantarflexion - 3rd wave : At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor."
11143915|NCT01837680|BG000|Baseline|Insulin NPH|Insulin neutral protamine Hagedorn
11143916|NCT01837680|BG001|Baseline|Levemir|Insulin detemir (IDet)
11143917|NCT01837680|BG002|Baseline|Total|Total of all reporting groups
11143918|NCT01837680|FG000|Participant Flow|Insulin NPH|Insulin neutral protamine Hagedorn (NPH) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
11143919|NCT01837680|FG001|Participant Flow|Levemir|Insulin detemir (IDet) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
11143920|NCT01837680|OG000|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
11143921|NCT01837680|OG001|Outcome|Levemir|Insulin detemir (IDet)
11143922|NCT01837680|EG000|Reported Event|Insulin NPH|Insulin neutral protamine Hagedorn
11143923|NCT01837680|EG001|Reported Event|Levemir|Insulin detemir (IDet)
11143924|NCT01837719|BG000|Baseline|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 29. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
11143925|NCT01837719|FG000|Participant Flow|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
11143926|NCT01837719|OG000|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
11143927|NCT01837719|OG001|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
11143928|NCT01837719|OG002|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
11143929|NCT01837719|OG003|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
11143930|NCT01837719|OG004|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
11143931|NCT01837719|OG003|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
11143932|NCT01837719|OG003|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or22
11143933|NCT01837719|OG004|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
11143934|NCT01837719|EG000|Reported Event|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8.
11143935|NCT01837719|EG001|Reported Event|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8.
11143936|NCT01837719|EG002|Reported Event|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22.
10879748|NCT00459667|BG003|Baseline|Total|Total of all reporting groups
11143937|NCT01837719|EG003|Reported Event|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22.
11143938|NCT01837719|EG004|Reported Event|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
11143939|NCT01837797|BG000|Baseline|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
11143940|NCT01837797|BG001|Baseline|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1 mg once daily, tablets, orally"
11143941|NCT01837797|BG002|Baseline|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 3 mg once daily, tablets, orally"
11143942|NCT01837797|BG003|Baseline|Total|Total of all reporting groups
11143943|NCT01837797|FG000|Participant Flow|Period 1 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
11143944|NCT01837797|FG001|Participant Flow|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
11143945|NCT01837797|FG002|Participant Flow|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
11143946|NCT01837797|FG003|Participant Flow|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
11143947|NCT01837797|FG004|Participant Flow|Period 3 Placebo and ADT|"Placebo adjunct to open-label treatment with commercially available antidepressant treatment (ADT)~Placebo: Once daily, tablets, orally"
11143948|NCT01837797|OG000|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
11143949|NCT01837797|OG001|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
10879749|NCT00459667|FG000|Participant Flow|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
11143950|NCT01837797|OG002|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
11143951|NCT01837797|EG000|Reported Event|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
11143952|NCT01837797|EG001|Reported Event|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1 mg once daily, tablets, orally"
11143953|NCT01837797|EG002|Reported Event|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 3 mg once daily, tablets, orally"
11143954|NCT01837823|BG000|Baseline|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
11143955|NCT01837823|FG000|Participant Flow|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
11143956|NCT01837823|OG000|Outcome|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
11143957|NCT01837823|OG000|Outcome|Baseline|Prior to rosuvastatin therapy
11143958|NCT01837823|OG001|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
11143959|NCT01837823|OG000|Outcome|Hp2-2|Hp2-2 genotype
11143960|NCT01837823|OG001|Outcome|Hp1-1/Hp 1-2|Hp1-1 or Hp 102 genotype
11143961|NCT01837823|EG000|Reported Event|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
11143962|NCT01837901|BG000|Baseline|Sham|Device was turned on but no stimulation was performed.
11143963|NCT01837901|BG001|Baseline|150%|Transcorneal electrostimulation with 150% of phosphene threshold.
11143964|NCT01837901|BG002|Baseline|200%|Transcorneal electrostimulation with 200% of phosphene threshold.
11143965|NCT01837901|BG003|Baseline|Total|Total of all reporting groups
11143966|NCT01837901|FG000|Participant Flow|Sham|OkuStim was used to determine the phosphene threshold, device was turned on but no stimulation was performed.
11143967|NCT01837901|FG001|Participant Flow|150%|OkuStim was used to determine the phosphene threshold, and then to administer transcorneal electrostimulation with a stimulation strength corresponding to 150% of the patient's phosphene threshold.
11143968|NCT01837901|FG002|Participant Flow|200%|OkuStim was used to determine the phosphene threshold, and then to administer transcorneal electrostimulation with a stimulation strength corresponding to 200% of the patient's phosphene threshold.
11143969|NCT01837901|OG000|Outcome|Sham|Device was turned on but no stimulation was performed.
11143970|NCT01837901|OG001|Outcome|150%|Transcorneal electrostimulation with 150% of phosphene threshold.
11143971|NCT01837901|OG002|Outcome|200%|Transcorneal electrostimulation with 200% of phosphene threshold.
11143972|NCT01837901|EG000|Reported Event|Sham|Device was turned on but no stimulation was performed.
11143973|NCT01837901|EG001|Reported Event|150%|Transcorneal electrostimulation with 150% of phosphene threshold.
11143974|NCT01837901|EG002|Reported Event|200%|Transcorneal electrostimulation with 200% of phosphene threshold.
11143975|NCT01837966|BG000|Baseline|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy"
11143976|NCT01837966|BG001|Baseline|Placebo|"Placebo - unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy"
11143977|NCT01837966|BG002|Baseline|Total|Total of all reporting groups
11143978|NCT01837966|FG000|Participant Flow|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy"
11143979|NCT01837966|FG001|Participant Flow|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy"
11143980|NCT01837966|OG000|Outcome|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy~There were no adverse events for this arm."
11143981|NCT01837966|OG001|Outcome|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy~There were no adverse events for this arm."
11143982|NCT01837966|EG000|Reported Event|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy~There were no adverse events for this arm."
11143983|NCT01837966|EG001|Reported Event|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy~There were no adverse events for this arm."
11143984|NCT01838044|BG000|Baseline|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143985|NCT01838044|BG001|Baseline|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up-titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143986|NCT01838044|BG002|Baseline|Total|Total of all reporting groups
11143987|NCT01838044|FG000|Participant Flow|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143988|NCT01838044|FG001|Participant Flow|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up-titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143989|NCT01838044|OG000|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143990|NCT01838044|OG001|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up-titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143991|NCT01838044|OG000|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up-titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143992|NCT01838044|EG000|Reported Event|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143993|NCT01838044|EG001|Reported Event|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up-titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
11143994|NCT01838200|BG000|Baseline|Cohort 1, Group 1 (BCG 0.16-0.64 × 10^6 CFU)|Patients with an induration <10 mm in diameter after the baseline PPD reactivity test received BCG (IL, 200 µL volume) at a dose of 0.16 - 0.64 × 10^6 CFU on Day 1. Isoniazid (300 mg) was administered orally every day from Days 29 through 56. Ipilimumab (3 mg/kg) was administered as a 90-minute IV infusion every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
11143995|NCT01838200|BG001|Baseline|Cohort 1, Group 2 (BCG 0.8-3.2 × 10^6 CFU)|Patients with an induration <10 mm in diameter after the baseline PPD reactivity test received BCG (IL, 200 µL volume) at a dose of 0.8 - 3.2 × 10^6 CFU on Day 1. Isoniazid (300 mg) was administered orally every day from Days 29 through 56. Ipilimumab (3 mg/kg) was administered as a 90-minute IV infusion every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
11143996|NCT01838200|BG002|Baseline|Total|Total of all reporting groups
11143997|NCT01838200|FG000|Participant Flow|Cohort 1, Group 1 (BCG 0.16-0.64 × 10^6 CFU)|Patients with an induration <10 mm in diameter after the baseline PPD reactivity test received BCG (IL, 200 µL volume) at a dose of 0.16 - 0.64 × 10^6 CFU on Day 1. Isoniazid (300 mg) was administered orally every day from Days 29 through 56. Ipilimumab (3 mg/kg) was administered as a 90-minute IV infusion every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
11143998|NCT01838200|FG001|Participant Flow|Cohort 1, Group 2 (BCG 0.8-3.2 × 10^6 CFU)|Patients with an induration <10 mm in diameter after the baseline PPD reactivity test received BCG (IL, 200 µL volume) at a dose of 0.8 - 3.2 × 10^6 CFU on Day 1. Isoniazid (300 mg) was administered orally every day from Days 29 through 56. Ipilimumab (3 mg/kg) was administered as a 90-minute IV infusion every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
11149871|NCT01874145|EG001|Reported Event|GA 40 mg/mL TIW (Core)|Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
10850953|NCT03410992|OG001|Outcome|Bimekizumab 320 mg Q4W (SS)|Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS.
11143999|NCT01838200|OG000|Outcome|Cohort 1, Group 1 (BCG 0.16-0.64 × 10^6 CFU)|Patients with an induration <10 mm in diameter after the baseline PPD reactivity test received BCG (IL, 200 µL volume) at a dose of 0.16 - 0.64 × 10^6 CFU on Day 1. Isoniazid (300 mg) was administered orally every day from Days 29 through 56. Ipilimumab (3 mg/kg) was administered as a 90-minute IV infusion every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
11144000|NCT01838200|OG001|Outcome|Cohort 1, Group 2 (BCG 0.8-3.2 × 10^6 CFU)|Patients with an induration <10 mm in diameter after the baseline PPD reactivity test received BCG (IL, 200 µL volume) at a dose of 0.8 - 3.2 × 10^6 CFU on Day 1. Isoniazid (300 mg) was administered orally every day from Days 29 through 56. Ipilimumab (3 mg/kg) was administered as a 90-minute IV infusion every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
11144001|NCT01838200|EG000|Reported Event|Cohort 1, Group 1 (BCG 0.16-0.64 × 10^6 CFU)|Patients with an induration <10 mm in diameter after the baseline PPD reactivity test received BCG (IL, 200 µL volume) at a dose of 0.16 - 0.64 × 10^6 CFU on Day 1. Isoniazid (300 mg) was administered orally every day from Days 29 through 56. Ipilimumab (3 mg/kg) was administered as a 90-minute IV infusion every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
11144002|NCT01838200|EG001|Reported Event|Cohort 1, Group 2 (BCG 0.8-3.2 × 10^6 CFU)|Patients with an induration <10 mm in diameter after the baseline PPD reactivity test received BCG (IL, 200 µL volume) at a dose of 0.8 - 3.2 × 10^6 CFU on Day 1. Isoniazid (300 mg) was administered orally every day from Days 29 through 56. Ipilimumab (3 mg/kg) was administered as a 90-minute IV infusion every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
11144003|NCT01838213|BG000|Baseline|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
11144004|NCT01838213|BG001|Baseline|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
11144005|NCT01838213|BG002|Baseline|Total|Total of all reporting groups
11144006|NCT01838213|FG000|Participant Flow|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
11144007|NCT01838213|FG001|Participant Flow|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
11144008|NCT01838213|OG000|Outcome|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
11144009|NCT01838213|OG001|Outcome|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
11144010|NCT01838213|EG000|Reported Event|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
11144011|NCT01838213|EG001|Reported Event|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
11144012|NCT01838226|BG000|Baseline|Group Prevention Clinics|A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Each group will consist of 10 patients. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction).
11144013|NCT01838226|BG001|Baseline|Treatment as Usual Control|Usual VA care
11144014|NCT01838226|BG002|Baseline|Total|Total of all reporting groups
11144015|NCT01838226|FG000|Participant Flow|Group Prevention Clinics|A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
11144016|NCT01838226|FG001|Participant Flow|Treatment as Usual Control|Usual VA care
11144017|NCT01838226|OG000|Outcome|Group Prevention Clinics|A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
10879750|NCT00459667|FG001|Participant Flow|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
11144018|NCT01838226|OG001|Outcome|Treatment as Usual Control|Usual VA care
11149872|NCT01874145|EG002|Reported Event|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
11149873|NCT01874145|EG003|Reported Event|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
11149874|NCT01874262|BG000|Baseline|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
11144019|NCT01838226|EG000|Reported Event|Group Prevention Clinics|A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
11144020|NCT01838226|EG001|Reported Event|Treatment as Usual Control|Usual VA care
11144021|NCT01838304|BG000|Baseline|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
11144022|NCT01838304|BG001|Baseline|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
11144023|NCT01838304|BG002|Baseline|Total|Total of all reporting groups
11144024|NCT01838304|FG000|Participant Flow|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
11144025|NCT01838304|FG001|Participant Flow|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
11144026|NCT01838304|OG000|Outcome|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
11144027|NCT01838304|OG001|Outcome|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
11144028|NCT01838304|EG000|Reported Event|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
11144029|NCT01838304|EG001|Reported Event|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
11144030|NCT01838317|BG000|Baseline|Pioglitazone and Chemotherapy in Patients Without Diabetes|45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
11144031|NCT01838317|BG001|Baseline|Pioglitazone and Chemotherapy in Patients With Diabetes|45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
11144032|NCT01838317|BG002|Baseline|Total|Total of all reporting groups
11144033|NCT01838317|FG000|Participant Flow|Pioglitazone and Chemotherapy Without Diabetes|45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
11144034|NCT01838317|FG001|Participant Flow|Pioglitazone and Chemotherapy - With Diabetes|45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
11144035|NCT01838317|OG000|Outcome|Pioglitazone and Chemotherapy Without Diabetes|45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
11144036|NCT01838317|OG001|Outcome|Pioglitazone and Chemotherapy - With Diabetes|45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
11144037|NCT01838317|EG000|Reported Event|Pioglitazone and Chemotherapy Without Diabetes|45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
11144038|NCT01838317|EG001|Reported Event|Pioglitazone and Chemotherapy - With Diabetes|45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
11144039|NCT01838447|BG000|Baseline|Usual Care Group|This group will receive daily cholecalciferol (vitamin D3) based on the Adequate Intake (AI) for infants and the Recommended Dietary Allowance (RDA) for children over 1 year. Specific dose amounts are 400 IU per day for infants (0-1 year), and 600 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a placebo solution.
11144040|NCT01838447|BG001|Baseline|High Dose Group|"This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.~Cholecalciferol: The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)"
11144041|NCT01838447|BG002|Baseline|Total|Total of all reporting groups
11144042|NCT01838447|FG000|Participant Flow|Usual Care Group|This group will receive daily cholecalciferol (vitamin D3) based on the Adequate Intake (AI) for infants and the Recommended Dietary Allowance (RDA) for children over 1 year. Specific dose amounts are 400 IU per day for infants (0-1 year), and 600 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a placebo solution.
11144043|NCT01838447|FG001|Participant Flow|High Dose Group|"This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.~Cholecalciferol: The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)"
11144044|NCT01838447|OG000|Outcome|Usual Care Group|This group will receive daily cholecalciferol (vitamin D3) based on the Adequate Intake (AI) for infants and the Recommended Dietary Allowance (RDA) for children over 1 year. Specific dose amounts are 400 IU per day for infants (0-1 year), and 600 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a placebo solution.
11144045|NCT01838447|OG001|Outcome|High Dose Group|"This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.~Cholecalciferol: The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)"
11144046|NCT01838447|EG000|Reported Event|Usual Care Group|This group will receive daily cholecalciferol (vitamin D3) based on the Adequate Intake (AI) for infants and the Recommended Dietary Allowance (RDA) for children over 1 year. Specific dose amounts are 400 IU per day for infants (0-1 year), and 600 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a placebo solution.
11144047|NCT01838447|EG001|Reported Event|High Dose Group|"This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.~Cholecalciferol: The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)"
11144048|NCT01838499|BG000|Baseline|MEDI8968|SC injection
11144049|NCT01838499|BG001|Baseline|Saline|SC injection
11144050|NCT01838499|BG002|Baseline|Total|Total of all reporting groups
11144051|NCT01838499|FG000|Participant Flow|MEDI8968|SC injection
11144052|NCT01838499|FG001|Participant Flow|Saline|SC injection
11144053|NCT01838499|OG000|Outcome|MEDI8968|SC injection
11144054|NCT01838499|OG001|Outcome|Saline|SC injection
11144055|NCT01838499|EG000|Reported Event|MEDI8968|SC injection
11144056|NCT01838499|EG001|Reported Event|Saline|SC injection
11144057|NCT01838551|BG000|Baseline|Levoketoconazole All Doses|All doses used in the study combined
11144058|NCT01838551|FG000|Participant Flow|Levoketoconazole All Doses|All doses used in the study combined
11144059|NCT01838551|OG000|Outcome|Levoketoconazole All Doses|All doses used in the study combined
11144060|NCT01838551|EG000|Reported Event|Levoketoconazole All Doses|All doses used in the study combined
11144061|NCT01838590|BG000|Baseline|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
11144062|NCT01838590|BG001|Baseline|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
11144063|NCT01838590|BG002|Baseline|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
11144064|NCT01838590|BG003|Baseline|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
11144065|NCT01838590|BG004|Baseline|Total|Total of all reporting groups
11144066|NCT01838590|FG000|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
11144067|NCT01838590|FG001|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11144068|NCT01838590|OG000|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
11144069|NCT01838590|OG001|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
11144070|NCT01838590|OG002|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
11144071|NCT01838590|OG003|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
11144072|NCT01838590|OG000|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
11144073|NCT01838590|OG001|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11144074|NCT01838590|EG000|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
11144075|NCT01838590|EG001|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11144076|NCT01838616|BG000|Baseline|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144077|NCT01838616|BG001|Baseline|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144078|NCT01838616|BG002|Baseline|Total|Total of all reporting groups
11144079|NCT01838616|FG000|Participant Flow|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11149875|NCT01874262|BG001|Baseline|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
11149876|NCT01874262|BG002|Baseline|Total|Total of all reporting groups
11144080|NCT01838616|FG001|Participant Flow|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144081|NCT01838616|OG000|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks
11144082|NCT01838616|OG001|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144083|NCT01838616|OG000|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144084|NCT01838616|OG001|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144085|NCT01838616|OG001|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144086|NCT01838616|OG001|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
10879751|NCT00459667|FG002|Participant Flow|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
11144087|NCT01838616|EG000|Reported Event|Tapentadol Prolonged Release (PR)|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144088|NCT01838616|EG001|Reported Event|Oxycodone/Naloxone Prolonged Release (PR)|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
11144089|NCT01838616|EG002|Reported Event|Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment|Participants in the oxycodone/naloxone PR treatment arm that did not reach the minimum target of titration or experiencing intolerable side effects at the end of the Titration Period could be switched to the Pick-up Arm. They could also enter the Pick-up Arm at any time during the Titration Period or Continuation Period, via an unscheduled visit, due to lack of tolerability or lack of efficacy under treatment with oxycodone/naloxone PR. Participants were directly switched from oxycodone/naloxone PR to tapentadol PR using an equianalgesic ratio of 1:5 (oxycodone : tapentadol), together with a down-titration step under tapentadol PR (except for participants on oxycodone/naloxone PR 10 mg/5 mg twice daily).
11144090|NCT01838642|BG000|Baseline|RET Mutation Positive Participants|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
11144091|NCT01838642|FG000|Participant Flow|RET Mutation Positive Participants.|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
11144092|NCT01838642|OG000|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
11144093|NCT01838642|OG000|Outcome|RET Mutation Positive Participants|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
11144094|NCT01838642|EG000|Reported Event|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
11144095|NCT01838655|BG000|Baseline|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
11144096|NCT01838655|FG000|Participant Flow|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
11144097|NCT01838655|OG000|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
11144098|NCT01838655|EG000|Reported Event|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
11144099|NCT01838681|BG000|Baseline|All Enrolled Patients|Period A
11144100|NCT01838681|FG000|Participant Flow|Period A Placebo and ADT (8 Weeks)|"Placebo adjunct to open-label treatment with ADT~Placebo: Once daily, tablets, orally"
11144101|NCT01838681|FG001|Participant Flow|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with ADT (same ADT as in Period A)~Placebo: Once daily, tablets, orally"
11144102|NCT01838681|FG002|Participant Flow|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with ADT (same ADT as in Period A)~Brexpiprazole: flexible dose; 1, 2, or 3 mg/day, once daily, tablets, orally"
11144103|NCT01838681|FG003|Participant Flow|Period A+ Placebo and ADT (Non-randomised Patients)|"Placebo adjunct to open-label treatment with ADT (same ADT as in Period A)~Placebo: Once daily, tablets, orally"
11144104|NCT01838681|OG000|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
11144105|NCT01838681|OG001|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
11144106|NCT01838681|EG000|Reported Event|Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
11144107|NCT01838681|EG001|Reported Event|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, 3, mg/day, once daily, tablets, orally"
11144108|NCT01838694|BG000|Baseline|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
11144109|NCT01838694|BG001|Baseline|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
11144110|NCT01838694|BG002|Baseline|Total|Total of all reporting groups
11144111|NCT01838694|FG000|Participant Flow|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
11144112|NCT01838694|FG001|Participant Flow|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
11144113|NCT01838694|OG000|Outcome|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
11144114|NCT01838694|OG001|Outcome|Ala-Cpn10 - 10mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 10mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
11144115|NCT01838694|OG002|Outcome|Ala-Cpn10 - 30mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
11144116|NCT01838694|OG003|Outcome|Ala-Cpn10 - 100mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
11144117|NCT01838694|OG004|Outcome|Ala-Cpn10 - 30mgs in Moderate SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
11144118|NCT01838694|EG000|Reported Event|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
11144119|NCT01838694|EG001|Reported Event|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range (0.16mg/kg [10mg twice weekly] to 5mg/kg [300mg twice weekly]) administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
11144120|NCT01838785|BG000|Baseline|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
11144121|NCT01838785|FG000|Participant Flow|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
11144122|NCT01838785|OG000|Outcome|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
11144123|NCT01838785|EG000|Reported Event|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
11144124|NCT01838863|BG000|Baseline|Plasma|"If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.~Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm."
11149877|NCT01874262|FG000|Participant Flow|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
11144125|NCT01838863|BG001|Baseline|Standard|"If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.~Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid"
11144126|NCT01838863|BG002|Baseline|Total|Total of all reporting groups
11144127|NCT01838863|FG000|Participant Flow|Plasma|"If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.~Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm."
11144128|NCT01838863|FG001|Participant Flow|Standard|"If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.~Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid"
11144129|NCT01838863|OG000|Outcome|Plasma|"If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.~Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm."
11144130|NCT01838863|OG001|Outcome|Standard|"If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.~Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid"
11144131|NCT01838863|EG000|Reported Event|Plasma|"If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.~Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm."
11144132|NCT01838863|EG001|Reported Event|Standard|"If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.~Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid"
11144133|NCT01838876|BG000|Baseline|Cariprazine + ADT|Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
11144134|NCT01838876|FG000|Participant Flow|Cariprazine + ADT|Cariprazine, flexible dose (titrated to a dose of 3.0milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
11144135|NCT01838876|OG000|Outcome|Cariprazine + ADT|Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
11144136|NCT01838876|OG000|Outcome|Cariprazine + ADT (Female)|Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigators judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks for female participants.
11144137|NCT01838876|OG001|Outcome|Cariprazine + ADT (Male)|Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigators judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks for male participants.
11144138|NCT01838876|EG000|Reported Event|Cariprazine + ADT|Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
11144139|NCT01838941|BG000|Baseline|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
11144140|NCT01838941|FG000|Participant Flow|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
11144141|NCT01838941|OG000|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
11144142|NCT01838941|OG000|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
11144143|NCT01838941|EG000|Reported Event|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
11144144|NCT01838980|BG000|Baseline|Colonoscopy|Motus GI Clean-Up Device
11144145|NCT01838980|FG000|Participant Flow|Colonoscopy|Motus GI Clean-Up Device
11144146|NCT01838980|OG000|Outcome|Colonoscopy|Motus GI Clean-Up Device
11144147|NCT01838980|EG000|Reported Event|Colonoscopy|Motus GI Clean-Up Device
11144148|NCT01839058|BG000|Baseline|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
11144149|NCT01839058|BG001|Baseline|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
11144150|NCT01839058|BG002|Baseline|Total|Total of all reporting groups
11144151|NCT01839058|FG000|Participant Flow|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
11144152|NCT01839058|FG001|Participant Flow|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
11144153|NCT01839058|OG000|Outcome|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
11144154|NCT01839058|OG001|Outcome|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
11144155|NCT01839058|EG000|Reported Event|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
11144156|NCT01839058|EG001|Reported Event|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
11144157|NCT01839110|BG000|Baseline|Ranolazine|"Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day~Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks."
10879752|NCT00459667|OG000|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
11144158|NCT01839110|BG001|Baseline|Placebo|"Placebo by mouth twice per day~Placebo: Placebo by mouth twice per day for a total of 26 weeks."
11144159|NCT01839110|BG002|Baseline|Observational|Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention.
11144160|NCT01839110|BG003|Baseline|Total|Total of all reporting groups
11144161|NCT01839110|FG000|Participant Flow|Ranolazine|"Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day~Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks."
11144162|NCT01839110|FG001|Participant Flow|Placebo|"Placebo by mouth twice per day~Placebo: Placebo by mouth twice per day for a total of 26 weeks."
11144163|NCT01839110|FG002|Participant Flow|Observational|Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention.
11144164|NCT01839110|OG000|Outcome|Ranolazine|"Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day~Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks."
11144165|NCT01839110|OG001|Outcome|Placebo|"Placebo by mouth twice per day~Placebo: Placebo by mouth twice per day for a total of 26 weeks."
11144166|NCT01839110|OG002|Outcome|Observational|Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention.
11144167|NCT01839110|EG000|Reported Event|Ranolazine|"Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day~Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks."
11144168|NCT01839110|EG001|Reported Event|Placebo|"Placebo by mouth twice per day~Placebo: Placebo by mouth twice per day for a total of 26 weeks."
11144169|NCT01839110|EG002|Reported Event|Observational|Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention.
11144170|NCT01839188|BG000|Baseline|PR5I (V1); Pediacel® (V2); PR5I (V3)|[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
11144171|NCT01839188|FG000|Participant Flow|PR5I (V1); Pediacel® (V2); PR5I (V3)|[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
11144172|NCT01839188|OG000|Outcome|PR5I (V1); Pediacel® (V2); PR5I (V3)|[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
11144173|NCT01839188|OG000|Outcome|PR5I (V1)|[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 2 months of age.
11144174|NCT01839188|OG001|Outcome|Pediacel® (V2)|[Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
11144175|NCT01839188|OG002|Outcome|PR5I (V3)|[Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
11144176|NCT01839188|OG003|Outcome|PR5I (V1); Pediacel® (V2); PR5I (V3)|[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
11144177|NCT01839188|OG002|Outcome|PR5I (V1); Pediacel® (V2)|[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
11144178|NCT01839188|EG000|Reported Event|PR5I (V1); Pediacel® (V2); PR5I (V3)|[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
11144179|NCT01839279|BG000|Baseline|Tizanidine|
11144180|NCT01839279|BG001|Baseline|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
11144181|NCT01839279|BG002|Baseline|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
11144182|NCT01839279|BG003|Baseline|Total|Total of all reporting groups
11144183|NCT01839279|FG000|Participant Flow|Tizanidine|
11144184|NCT01839279|FG001|Participant Flow|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
11144185|NCT01839279|FG002|Participant Flow|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
11144186|NCT01839279|OG000|Outcome|Tizanidine 24 mg|60 subjects Tizanidine 24 mg single dose
11144187|NCT01839279|OG001|Outcome|Tizanidine Placebo 24 mg|61 subjects placebo used for the analysis.
11144188|NCT01839279|OG002|Outcome|Tizanidine 24 mg Placebo-corrected|60 subjects Tizanidine 24 mg single dose, 61 subjects placebo used for the analysis.
11144189|NCT01839279|OG000|Outcome|Tizanidine 8 mg|70 subjects Tizanidine 8 mg single dose.
11144190|NCT01839279|OG001|Outcome|Tizanidine Placebo 8 mg|63 subjects placebo used for analysis.
11144191|NCT01839279|OG002|Outcome|Tizanidine 8 mg Placebo-corrected|70 subjects Tizanidine 8 mg single dose, 63 subjects placebo used for analysis.
11144192|NCT01839279|OG000|Outcome|Tizanidine|
11144193|NCT01839279|OG000|Outcome|Day 5 (Tizanidine 8 mg)|
11144194|NCT01839279|OG001|Outcome|Day 14 (Tizanidine 24 mg)|
11144195|NCT01839279|EG000|Reported Event|Tizanidine|Tizanidine Arm
11144196|NCT01839279|EG001|Reported Event|Initial Placebo and Crossover to Moxifloxacin|Placebo/Moxifloxacin Arm
11144197|NCT01839279|EG002|Reported Event|Initial Moxifloxacin and Crossover to Placebo|Moxifloxacin/Placebo Arm
11144198|NCT01839279|EG003|Reported Event|Placebo and Moxifloxacin Groups Combined|Combined Moxifloxacin Arm
11144199|NCT01839318|BG000|Baseline|Overall|Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment.
11144200|NCT01839318|FG000|Participant Flow|Sequence 1|Omafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
11144201|NCT01839318|FG001|Participant Flow|Sequence 2|Omafilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
11144202|NCT01839318|FG002|Participant Flow|Sequence 3|Nelfilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
11144203|NCT01839318|FG003|Participant Flow|Sequence 4|Nelfilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
11144204|NCT01839318|FG004|Participant Flow|Sequence 5|Etafilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
11144205|NCT01839318|FG005|Participant Flow|Sequence 6|Etafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
11144206|NCT01839318|OG000|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
11144207|NCT01839318|OG001|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
11144208|NCT01839318|OG002|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
11144209|NCT01839318|EG000|Reported Event|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
11144210|NCT01839318|EG001|Reported Event|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
11144211|NCT01839318|EG002|Reported Event|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
11144212|NCT01839487|BG000|Baseline|PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine|Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after the dose of PEGPH20. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.
11144213|NCT01839487|BG001|Baseline|AG: Nab-paclitaxel + Gemcitabine|Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
11144214|NCT01839487|BG002|Baseline|Total|Total of all reporting groups
11144215|NCT01839487|FG000|Participant Flow|Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine|Participants received 3.0 micrograms/kilogram (mcg/kg) PEGPH20 with 125 milligrams/square meter (mg/m^2) nab-paclitaxel (NAB) and 1000 mg/m^2 gemcitabine (GEM) as intravenous (IV) infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after PEGPH20 dose. Each cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion.
11144216|NCT01839487|FG001|Participant Flow|Run-in Phase - AG: Nab-paclitaxel + Gemcitabine|Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
11149878|NCT01874262|FG001|Participant Flow|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
11144217|NCT01839487|FG002|Participant Flow|Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine|Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were administered once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after the dose of PEGPH20. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.
11144218|NCT01839487|FG003|Participant Flow|Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine|Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
11144219|NCT01839487|FG004|Participant Flow|Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine|Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after dose of PEGPH20. Each cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion. Enoxaparin 40 mg/day or 1 mg/kg/day was given subcutaneously (SC).
11144220|NCT01839487|FG005|Participant Flow|Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine|Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. Enoxaparin 40 mg/day or 1 mg/kg/day was given SC.
11144221|NCT01839487|OG000|Outcome|PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine|Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after the dose of PEGPH20. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.
11144222|NCT01839487|OG001|Outcome|AG: Nab-paclitaxel + Gemcitabine|Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
11144223|NCT01839487|OG000|Outcome|Run-in Phase 1-PAG: PEGPH20 (Original Formulation) + NAB + GEM|Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB, and 1000 mg/m^2 GEM, as IV infusion. In Cycle 1 Week 1, PEGPH20 was administered alone on Day 1, 4, and NAB+GEM were administered on Day 2, approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, 18, and NAB+GEM were given once/week, 2 to 4 hours after PEGPH20 administration on Days 8, 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, 15. NAB+GEM were given 2 to 4 hours after PEGPH20 dose. Each treatment cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment). Treatment was continued until disease progression or unacceptable toxicity. Dexamethasone 8 mg was administered in each treatment cycle within 2 hours prior to beginning of each PEGPH20 infusion and 8 to 12 hours after completion of each PEGPH20 infusion.
11144224|NCT01839487|OG001|Outcome|Run-in Phase 2- PAG: PEGPH20 (New Formulation) + NAB + GEM|Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB, and 1000 mg/m^2 GEM, as IV infusion. In Cycle 1 Week 1, PEGPH20 was administered alone on Day 1, 4, and NAB+GEM were administered on Day 2, approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, 18, and NAB+GEM were given once/week, 2 to 4 hours after PEGPH20 administration on Days 8, 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, 15. NAB+GEM were given 2 to 4 hours after PEGPH20 dose. Each treatment cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment). Treatment was continued until disease progression or unacceptable toxicity. Dexamethasone 8 mg was administered in each treatment cycle within 2 hours prior to beginning of each PEGPH20 infusion and 8 to 12 hours after completion of each PEGPH20 infusion.
11149879|NCT01874262|OG000|Outcome|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
11149880|NCT01874262|OG001|Outcome|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
11144225|NCT01839487|EG000|Reported Event|PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine|Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after the dose of PEGPH20. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.
11144226|NCT01839487|EG001|Reported Event|AG: Nab-paclitaxel + Gemcitabine|Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
11144227|NCT01839604|BG000|Baseline|AZD9150 1mg/kg|Intravenous. Part A.
11144228|NCT01839604|BG001|Baseline|1.5 mg/kg|given intravenously. Part A
11144229|NCT01839604|BG002|Baseline|2 mg/kg|given intravenously Part A
11144230|NCT01839604|BG003|Baseline|2.5 mg/kg|given intravenously Part A
11144231|NCT01839604|BG004|Baseline|3 mg/kg|given intravenously (Part A & B pooled)
11144232|NCT01839604|BG005|Baseline|Total|Total of all reporting groups
11144233|NCT01839604|FG000|Participant Flow|AZD9150 1mg/kg|Intravenous. Part A.
11144234|NCT01839604|FG001|Participant Flow|AZD9150 1.5 mg/kg|Intravenous dosing Part A
11144235|NCT01839604|FG002|Participant Flow|AZD9150 2mg/kg|Intravenous dosing Part A
11144236|NCT01839604|FG003|Participant Flow|AZD9150 2.5mg/kg|Intravenous dosing Part A
11144237|NCT01839604|FG004|Participant Flow|AZD9150 3mg/kg|Pooled over parts A & B
11144238|NCT01839604|OG000|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
11144239|NCT01839604|OG001|Outcome|1.5 mg/kg|given intravenously. Part A
11144240|NCT01839604|OG002|Outcome|2 mg/kg|given intravenously Part A
11144241|NCT01839604|OG003|Outcome|2.5 mg/kg|given intravenously Part A
11144242|NCT01839604|OG004|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
11144243|NCT01839604|EG000|Reported Event|AZD9150 1mg/kg|Intravenous. Part A.
11144244|NCT01839604|EG001|Reported Event|1.5 mg/kg|given intravenously. Part A
11144245|NCT01839604|EG002|Reported Event|2 mg/kg|given intravenously Part A
11144246|NCT01839604|EG003|Reported Event|2.5 mg/kg|given intravenously Part A
11144247|NCT01839604|EG004|Reported Event|3 mg/kg|given intravenously (Part A & B pooled)
11144248|NCT01839656|BG000|Baseline|Nusinersen 6 mg|Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261.
11144249|NCT01839656|BG001|Baseline|Nusinersen 12 mg|Participants received nusinersen 12 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261.
11144250|NCT01839656|BG002|Baseline|Total|Total of all reporting groups
11144251|NCT01839656|FG000|Participant Flow|Nusinersen 6 mg|Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261.
11144252|NCT01839656|FG001|Participant Flow|Nusinersen 12 mg|Participants received nusinersen 12 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261.
11144253|NCT01839656|OG000|Outcome|Nusinersen 6 mg|Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261.
11144254|NCT01839656|OG001|Outcome|Nusinersen 12 mg|Participants received nusinersen 12 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261.
11144255|NCT01839656|EG000|Reported Event|Nusinersen 6 mg|Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261.
11144256|NCT01839656|EG001|Reported Event|Nusinersen 12 mg|Participants aged 21 days to 7 months old with infantile-onset SMA received nusinersen 12 mg injections at regular intervals for up to 45 months.
11144257|NCT01839695|BG000|Baseline|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft>~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
11144258|NCT01839695|FG000|Participant Flow|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft>~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
11144259|NCT01839695|OG000|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
11144260|NCT01839695|EG000|Reported Event|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
11144261|NCT01839708|BG000|Baseline|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
11144262|NCT01839708|BG001|Baseline|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
11144263|NCT01839708|BG002|Baseline|Total|Total of all reporting groups
11144264|NCT01839708|FG000|Participant Flow|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
11144265|NCT01839708|FG001|Participant Flow|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
11144266|NCT01839708|OG000|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
11144267|NCT01839708|OG001|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
11144268|NCT01839708|EG000|Reported Event|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
11144269|NCT01839708|EG001|Reported Event|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
11144270|NCT01839799|BG000|Baseline|FOLFIRINOX|"FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated~Chemoradiation"
11144271|NCT01839799|BG001|Baseline|Gemcitabine|"Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15~Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15~Chemoradiation"
11144272|NCT01839799|BG002|Baseline|Total|Total of all reporting groups
11144273|NCT01839799|FG000|Participant Flow|FOLFIRINOX|"FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated~Chemoradiation"
11144274|NCT01839799|FG001|Participant Flow|Gemcitabine/Abraxane|"Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15~Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15~Chemoradiation"
11144275|NCT01839799|OG000|Outcome|Arm 1|"FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated~Chemoradiation"
11144276|NCT01839799|OG001|Outcome|Arm 2|"Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15~Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15~Chemoradiation"
11144277|NCT01839799|EG000|Reported Event|Arm 1|"FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated~Chemoradiation"
10850954|NCT03410992|OG000|Outcome|Placebo/Placebo (WK16ResS)|Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).
11144278|NCT01839799|EG001|Reported Event|Arm 2|"Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15~Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15~Chemoradiation"
11144279|NCT01839916|BG000|Baseline|Treatment (DLI)|"Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.~therapeutic allogeneic lymphocytes: Given IV~laboratory biomarker analysis: Correlative studies"
11144280|NCT01839916|FG000|Participant Flow|Treatment (DLI)|"Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.~therapeutic allogeneic lymphocytes: Given IV~laboratory biomarker analysis: Correlative studies"
11144281|NCT01839916|OG000|Outcome|Treatment (DLI)|"Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.~therapeutic allogeneic lymphocytes: Given IV~laboratory biomarker analysis: Correlative studies"
11144282|NCT01839916|EG000|Reported Event|Treatment (DLI)|"Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.~therapeutic allogeneic lymphocytes: Given IV~laboratory biomarker analysis: Correlative studies"
11144283|NCT01840072|BG000|Baseline|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
11144284|NCT01840072|BG001|Baseline|Usual Care|Discontinue all home BP medications.
11144285|NCT01840072|BG002|Baseline|Total|Total of all reporting groups
11144286|NCT01840072|FG000|Participant Flow|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
11144287|NCT01840072|FG001|Participant Flow|Usual Care|Discontinue all home BP medications.
11144288|NCT01840072|OG000|Outcome|Usual Care|Discontinue all home BP medications.
11144289|NCT01840072|OG001|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
11144290|NCT01840072|OG000|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
11144291|NCT01840072|OG001|Outcome|Usual Care|Discontinue all home BP medications.
11144292|NCT01840072|EG000|Reported Event|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
11144293|NCT01840072|EG001|Reported Event|Usual Care|Discontinue all home BP medications.
11144294|NCT01840163|BG000|Baseline|CanSORT Online Tool (Intervention)|"Comprehensive (interactive) version of decision tool~CanSORT Online Tool"
11144295|NCT01840163|BG001|Baseline|Static Version of CanSORT Tool (Control)|"Static version (non-interactive) version of CanSORT decision tool~Static version of CanSORT tool"
11144296|NCT01840163|BG002|Baseline|Total|Total of all reporting groups
11144297|NCT01840163|FG000|Participant Flow|CanSORT Online Tool (Intervention)|"Comprehensive (interactive) version of decision tool~CanSORT Online Tool"
11144298|NCT01840163|FG001|Participant Flow|Static Version of CanSORT Tool (Control)|"Static version (non-interactive) version of CanSORT decision tool~Static version of CanSORT tool"
11144299|NCT01840163|OG000|Outcome|CanSORT Online Tool (Intervention)|"Comprehensive (interactive) version of decision tool~CanSORT Online Tool"
11144300|NCT01840163|OG001|Outcome|Static Version of CanSORT Tool (Control)|"Static version (non-interactive) version of CanSORT decision tool~Static version of CanSORT tool"
11144301|NCT01840163|EG000|Reported Event|CanSORT Online Tool (Intervention)|"Comprehensive (interactive) version of decision tool~CanSORT Online Tool"
11144302|NCT01840163|EG001|Reported Event|Static Version of CanSORT Tool (Control)|"Static version (non-interactive) version of CanSORT decision tool~Static version of CanSORT tool"
11144303|NCT01840228|BG000|Baseline|Micronized Progesterone Suppository|"Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.~Micronized progesterone suppository"
11144304|NCT01840228|BG001|Baseline|Placebo Suppository|"One placebo suppository vaginally daily until 36 6/7 weeks' gestation.~Micronized progesterone suppository"
11144305|NCT01840228|BG002|Baseline|Total|Total of all reporting groups
11144306|NCT01840228|FG000|Participant Flow|Micronized Progesterone Suppository|"Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.~Micronized progesterone suppository"
11144307|NCT01840228|FG001|Participant Flow|Placebo Suppository|"One placebo suppository vaginally daily until 36 6/7 weeks' gestation.~Micronized progesterone suppository"
11144308|NCT01840228|OG000|Outcome|Micronized Progesterone Suppository|"Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.~Micronized progesterone suppository"
11144309|NCT01840228|OG001|Outcome|Placebo Suppository|"One placebo suppository vaginally daily until 36 6/7 weeks' gestation.~Micronized progesterone suppository"
11144310|NCT01840228|OG000|Outcome|Micronized Progesterone Suppository - SINGLETON|"Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in singleton subgroup.~Micronized progesterone suppository"
11144311|NCT01840228|OG001|Outcome|Placebo Suppository - SINGLETON|"One placebo suppository vaginally daily until 36 6/7 weeks' gestation in singleton subgroup~Micronized progesterone suppository"
11144312|NCT01840228|OG002|Outcome|Micronized Progesterone Suppository - TWINS|"Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.~Micronized progesterone suppository"
11144313|NCT01840228|OG003|Outcome|Placebo Suppository - TWINS|"One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup~Micronized progesterone suppository"
11144314|NCT01840228|EG000|Reported Event|Micronized Progesterone Suppository|"Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.~Micronized progesterone suppository"
11144315|NCT01840228|EG001|Reported Event|Placebo Suppository|"One placebo suppository vaginally daily until 36 6/7 weeks' gestation.~Micronized progesterone suppository"
11144316|NCT01840319|BG000|Baseline|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
11144317|NCT01840319|FG000|Participant Flow|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
11144318|NCT01840319|OG000|Outcome|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
11144319|NCT01840319|EG000|Reported Event|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
11144320|NCT01840345|BG000|Baseline|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
11144321|NCT01840345|FG000|Participant Flow|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
11144322|NCT01840345|OG000|Outcome|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
11144323|NCT01840345|EG000|Reported Event|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
11144324|NCT01840410|BG000|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
11144325|NCT01840410|BG001|Baseline|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
11144326|NCT01840410|BG002|Baseline|Total|Total of all reporting groups
11144327|NCT01840410|FG000|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
11144328|NCT01840410|FG001|Participant Flow|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
11144329|NCT01840410|OG000|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
11144330|NCT01840410|OG001|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
11144331|NCT01840410|OG002|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
11144332|NCT01840410|EG000|Reported Event|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
11144333|NCT01840410|EG001|Reported Event|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
11144334|NCT01840410|EG002|Reported Event|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
11144335|NCT01840579|BG000|Baseline|Part A: Pembrolizumab 2 mg/kg|In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
11144336|NCT01840579|BG001|Baseline|Part A: Pembrolizumab 10 mg/kg|In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
11144337|NCT01840579|BG002|Baseline|Part B: Pembrolizumab+Cisplatin/Pemetrexed|In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144338|NCT01840579|BG003|Baseline|Part B: Pembrolizumab+Carboplatin/Pemetrexed|In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144339|NCT01840579|BG004|Baseline|Part C: Pembrolizumab+Carboplatin/Paclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144340|NCT01840579|BG005|Baseline|Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144341|NCT01840579|BG006|Baseline|Part D: Pembrolizumab+Ipilimumab|In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
11144342|NCT01840579|BG007|Baseline|Part E: Pembrolizumab+Cisplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144343|NCT01840579|BG008|Baseline|Part E: Pembrolizumab+Carboplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144344|NCT01840579|BG009|Baseline|Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144345|NCT01840579|BG010|Baseline|Total|Total of all reporting groups
11144346|NCT01840579|FG000|Participant Flow|Part A: Pembrolizumab 2 mg/kg|In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
11144347|NCT01840579|FG001|Participant Flow|Part A: Pembrolizumab 10 mg/kg|In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
11144348|NCT01840579|FG002|Participant Flow|Part B: Pembrolizumab+Cisplatin/Pemetrexed|In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144349|NCT01840579|FG003|Participant Flow|Part B: Pembrolizumab+Carboplatin/Pemetrexed|In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144350|NCT01840579|FG004|Participant Flow|Part C: Pembrolizumab+Carboplatin/Paclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144351|NCT01840579|FG005|Participant Flow|Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144352|NCT01840579|FG006|Participant Flow|Part D: Pembrolizumab+Ipilimumab|In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
11144353|NCT01840579|FG007|Participant Flow|Part E: Pembrolizumab+Cisplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144354|NCT01840579|FG008|Participant Flow|Part E: Pembrolizumab+Carboplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144355|NCT01840579|FG009|Participant Flow|Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144356|NCT01840579|OG000|Outcome|Part A: Pembrolizumab 2 mg/kg|In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
11144357|NCT01840579|OG001|Outcome|Part A: Pembrolizumab 10 mg/kg|In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
11144358|NCT01840579|OG002|Outcome|Part B: Pembrolizumab+Cisplatin/Pemetrexed|In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144359|NCT01840579|OG003|Outcome|Part B: Pembrolizumab+Carboplatin/Pemetrexed|In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144360|NCT01840579|OG004|Outcome|Part C: Pembrolizumab+Carboplatin/Paclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144361|NCT01840579|OG005|Outcome|Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144362|NCT01840579|OG006|Outcome|Part D: Pembrolizumab+Ipilimumab|In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
11144363|NCT01840579|OG007|Outcome|Part E: Pembrolizumab+Cisplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144364|NCT01840579|OG008|Outcome|Part E: Pembrolizumab+Carboplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144365|NCT01840579|OG009|Outcome|Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144366|NCT01840579|OG002|Outcome|Part D: Pembrolizumab+Ipilimumab|In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
11144367|NCT01840579|OG006|Outcome|Part E: Pembrolizumab+Cisplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144368|NCT01840579|OG007|Outcome|Part E: Pembrolizumab+Carboplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144369|NCT01840579|OG008|Outcome|Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144370|NCT01840579|OG000|Outcome|Part D: Pembrolizumab+Ipilimumab|In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
11144371|NCT01840579|OG000|Outcome|Part B: Pembrolizumab+Cisplatin/Pemetrexed|In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144372|NCT01840579|OG001|Outcome|Part B: Pembrolizumab+Carboplatin/Pemetrexed|In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144373|NCT01840579|OG002|Outcome|Part C: Pembrolizumab+Carboplatin/Paclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144374|NCT01840579|OG003|Outcome|Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144375|NCT01840579|OG004|Outcome|Part E: Pembrolizumab+Cisplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144376|NCT01840579|OG005|Outcome|Part E: Pembrolizumab+Carboplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144377|NCT01840579|OG006|Outcome|Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
10850955|NCT03410992|OG001|Outcome|Bimekizumab 320 mg Q4W/Placebo (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
11144378|NCT01840579|EG000|Reported Event|Part A: Pembrolizumab 2 mg/kg|In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
11144379|NCT01840579|EG001|Reported Event|Part A: Pembrolizumab 10 mg/kg|In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
11144380|NCT01840579|EG002|Reported Event|Part B: Pembrolizumab+Cisplatin/Pemetrexed|In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11224652|NCT02362321|BG000|Baseline|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
11224653|NCT02362321|BG001|Baseline|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
11224654|NCT02362321|BG002|Baseline|Total|Total of all reporting groups
11224655|NCT02362321|FG000|Participant Flow|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
11224656|NCT02362321|FG001|Participant Flow|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
11224657|NCT02362321|OG000|Outcome|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
11224658|NCT02362321|OG001|Outcome|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
11224659|NCT02362321|EG000|Reported Event|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
10850956|NCT03410992|OG002|Outcome|Bimekizumab 320 mg Q4W/Q8W (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
11224660|NCT02362321|EG001|Reported Event|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
11224661|NCT02362360|BG000|Baseline|Overall Study Population|All subjects included in the investigation
11224662|NCT02362360|FG000|Participant Flow|Coloplast Test Product Then Comparator|"The subject first tests the Coloplast Test Product and then tests the Comparator~Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S~Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
11224663|NCT02362360|FG001|Participant Flow|Comparator Then Coloplast Test Product|"The subject first tests the Comparator and then tests the Coloplast Test Product.~Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S~Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
11224664|NCT02362360|OG000|Outcome|Coloplast Test Product|Answers from subjects testing Coloplast test product
11224665|NCT02362360|OG001|Outcome|Comparator|Answers from subjects testing Comparator
11224666|NCT02362360|EG000|Reported Event|Coloplast Test Product|Answers from subjects testing Coloplast test product
11224667|NCT02362360|EG001|Reported Event|Comparator|Answers from subjects testing Comparator
11224668|NCT02362373|BG000|Baseline|Levonorgestrel IUS|"all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.~levonorgestrel IUS: placement of levonorgestrel intrauterine system"
11224669|NCT02362373|FG000|Participant Flow|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
11224670|NCT02362373|OG000|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
11224671|NCT02362373|EG000|Reported Event|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
11224672|NCT02362412|BG000|Baseline|All Study Participants|Participants who received either FK949E 50 mg tablets or FK949E 150 mg tablets once daily. The analysis population was the Full Analysis Set (FAS), which consisted of all participants who received at least one dose of the study drug and who had at least one efficacy measurement after the start of treatment with the study drug.
11224673|NCT02362412|FG000|Participant Flow|FK949E 50 mg / FK949E 150 mg|Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks).
11224674|NCT02362412|FG001|Participant Flow|FK949E 150 mg / FK949E 50 mg|Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).
11224675|NCT02362412|OG000|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
11224676|NCT02362412|OG001|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
11224677|NCT02362412|OG000|Outcome|Treatment Period II FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks).
11224678|NCT02362412|OG001|Outcome|Treatment Period II FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period II (8 weeks).
11224679|NCT02362412|OG002|Outcome|Treatment Period III FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks).
11144381|NCT01840579|EG003|Reported Event|Part B: Pembrolizumab+Carboplatin/Pemetrexed|In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
11144382|NCT01840579|EG004|Reported Event|Part C: Pembrolizumab+Carboplatin/Paclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144383|NCT01840579|EG005|Reported Event|Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel|In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144384|NCT01840579|EG006|Reported Event|Part D: Pembrolizumab+Ipilimumab|In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
11144385|NCT01840579|EG007|Reported Event|Part E: Pembrolizumab+Cisplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
10879753|NCT00459667|OG001|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
11144386|NCT01840579|EG008|Reported Event|Part E: Pembrolizumab+Carboplatin/Etoposide|In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144387|NCT01840579|EG009|Reported Event|Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF|In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
11144388|NCT01840605|BG000|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
11144389|NCT01840605|BG001|Baseline|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
11144390|NCT01840605|BG002|Baseline|Total|Total of all reporting groups
11144391|NCT01840605|FG000|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
11144392|NCT01840605|FG001|Participant Flow|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
11144393|NCT01840605|OG000|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
11144394|NCT01840605|OG001|Outcome|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
11144395|NCT01840605|EG000|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
11144396|NCT01840605|EG001|Reported Event|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
11149881|NCT01874262|EG000|Reported Event|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
11149882|NCT01874262|EG001|Reported Event|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
11149883|NCT01874275|BG000|Baseline|VECTTOR - Active|nerve stimulator treatment twice daily for duration of study - 365 days ...
11149884|NCT01874275|BG001|Baseline|Device Sham|placebo treatment - no nerve stimulator treatment twice daily for 180 days of study
11149885|NCT01874275|BG002|Baseline|Total|Total of all reporting groups
11149886|NCT01874275|FG000|Participant Flow|VECTTOR|"muscle stimulator treatment twice daily for duration of study - 365 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
11149887|NCT01874275|FG001|Participant Flow|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by active treatment for the duration of study, 365 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
11149888|NCT01874275|OG000|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study - assessed at 180 days
11149889|NCT01874275|OG001|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
11149890|NCT01874275|OG000|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study
11149891|NCT01874275|OG001|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by muscle stimulator treatment twice daily for 180 days
11224680|NCT02362412|OG003|Outcome|Treatment Period III FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks).
11144397|NCT01840722|BG000|Baseline|NIDA Standard HIV Education|NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources
11144398|NCT01840722|BG001|Baseline|MI-based HIV Risk Reduction|"MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community.~MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months."
11144399|NCT01840722|BG002|Baseline|Total|Total of all reporting groups
11144400|NCT01840722|FG000|Participant Flow|NIDA Standard HIV Education|NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources
11144401|NCT01840722|FG001|Participant Flow|MI-based HIV Risk Reduction|"MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community.~MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months."
11144402|NCT01840722|OG000|Outcome|NIDA Standard HIV Education|NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources
11144403|NCT01840722|OG001|Outcome|MI-based HIV Risk Reduction|"MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community.~MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months."
11144404|NCT01840722|EG000|Reported Event|NIDA Standard HIV Education|NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources
11144405|NCT01840722|EG001|Reported Event|MI-based HIV Risk Reduction|"MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community.~MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months."
11144406|NCT01840943|BG000|Baseline|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
11144407|NCT01840943|BG001|Baseline|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
11144408|NCT01840943|BG002|Baseline|Total|Total of all reporting groups
11144409|NCT01840943|FG000|Participant Flow|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
11144410|NCT01840943|FG001|Participant Flow|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
11144411|NCT01840943|OG000|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
11144412|NCT01840943|OG001|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
11144413|NCT01840943|EG000|Reported Event|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
11144414|NCT01840943|EG001|Reported Event|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
11144415|NCT01841021|BG000|Baseline|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
11144416|NCT01841021|FG000|Participant Flow|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
11144417|NCT01841021|OG000|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
11144418|NCT01841021|EG000|Reported Event|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
11144419|NCT01841047|BG000|Baseline|Radiotherapy|"Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.~Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable"
11144420|NCT01841047|FG000|Participant Flow|Radiotherapy|"Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.~Helical tomotherapy (54 Gy) will take place over 6 consecutive weeks with 30 fractions of 1.8 Gy : 5 fractions per week followed by 2 days off. The surgery takes place between 2 and 8 weeks after the end of the tomotherapy."
11144421|NCT01841047|OG000|Outcome|Radiotherapy|"Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.~Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable"
11144422|NCT01841047|EG000|Reported Event|Radiotherapy|"Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.~Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable"
11144423|NCT01841060|BG000|Baseline|Patients Treated With Radiofrequency Ablation (RFA)|RFA treatment: Computed tomography (CT) was used to treat tumors under general anesthesia. Thoracic epidural anesthesia was administered in case of contraindication to general anesthesia mostly due to poor respiratory function. All patients were treated with the same multitine electrodes (LeVeen; Boston Scientific, Nattick. MA) measuring 3, 3.5, or 4 cm in diameter and at least 10 mm larger than the diameter of the target tumor. Multiple overlapping ablations were performed, when needed, in different parts of the tumor in order to cover the entire volume.
11144424|NCT01841060|FG000|Participant Flow|Patients Treated With Radiofrequency Ablation (RFA)|RFA treatment: Computed tomography (CT) was used to treat tumors under general anesthesia. Thoracic epidural anesthesia was administered in case of contraindication to general anesthesia mostly due to poor respiratory function. All patients were treated with the same multitine electrodes (LeVeen; Boston Scientific, Nattick. MA) measuring 3, 3.5, or 4 cm in diameter and at least 10 mm larger than the diameter of the target tumor. Multiple overlapping ablations were performed, when needed, in different parts of the tumor in order to cover the entire volume.
11144425|NCT01841060|OG000|Outcome|Patients Treated With Radiofrequency Ablation (RFA)|RFA treatment: Computed tomography (CT) was used to treat tumors under general anesthesia. Thoracic epidural anesthesia was administered in case of contraindication to general anesthesia mostly due to poor respiratory function. All patients were treated with the same multitine electrodes (LeVeen; Boston Scientific, Nattick. MA) measuring 3, 3.5, or 4 cm in diameter and at least 10 mm larger than the diameter of the target tumor. Multiple overlapping ablations were performed, when needed, in different parts of the tumor in order to cover the entire volume.
11144426|NCT01841060|EG000|Reported Event|Radiofrequency Ablathermy|Percutaneous radiofrequency ablation (RFA)
11144427|NCT01841073|BG000|Baseline|Inulin|Participant received inulin
11144428|NCT01841073|BG001|Baseline|Cellulose|Participants received cellulose
11144429|NCT01841073|BG002|Baseline|Total|Total of all reporting groups
11144430|NCT01841073|FG000|Participant Flow|Inulin|Inulin intervention
10850957|NCT03410992|OG003|Outcome|Bimekizumab 320 mg Q4W/Q4W (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
11144431|NCT01841073|FG001|Participant Flow|Cellulose|Cellulose intervention
11144432|NCT01841073|OG000|Outcome|Inulin|Received Inulin intervention
11144433|NCT01841073|OG001|Outcome|Cellulose|Received Cellulose intervention
11144434|NCT01841073|OG000|Outcome|Inulin|Inulin intervention
11144435|NCT01841073|OG001|Outcome|Cellulose|Cellulose intervention
11144436|NCT01841073|EG000|Reported Event|Inulin|Received Inulin intervention
11144437|NCT01841073|EG001|Reported Event|Cellulose|Received Cellulose intervention
11144438|NCT01841216|BG000|Baseline|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
11144439|NCT01841216|BG001|Baseline|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
11144440|NCT01841216|BG002|Baseline|Total|Total of all reporting groups
11144441|NCT01841216|FG000|Participant Flow|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
11144442|NCT01841216|FG001|Participant Flow|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
11144443|NCT01841216|OG000|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
11144444|NCT01841216|OG001|Outcome|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
11144445|NCT01841216|EG000|Reported Event|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
11144446|NCT01841216|EG001|Reported Event|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
11144447|NCT01841281|BG000|Baseline|Low Exhaled Nitric Oxide (NO)|"Subjects with a baseline exhaled NO level less than or equal to 20 ppb will be enrolled in the Low Exhaled Nitric Oxide arm.~Baseline characteristics at the enrollment"
11144448|NCT01841281|BG001|Baseline|High Exhaled Nitric Oxide (NO)|"Subjects with a baseline exhaled NO level greater than or equal to 25 ppb will be enrolled in the High Exhaled Nitric Oxide arm.~Baseline characteristics at the enrollment"
11144449|NCT01841281|BG002|Baseline|Total|Total of all reporting groups
11144450|NCT01841281|FG000|Participant Flow|Low Exhaled Nitric Oxide (NO), L-Arginine First, Then Placebo|"Subjects with a baseline exhaled NO level less than or equal to 20 ppb~Receive L-arginine first, then Placebo~L-Arginine: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.~Placebo: Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients."
11144451|NCT01841281|FG001|Participant Flow|High Exhaled Nitric Oxide (NO), L-Arginine First, Then Placebo|"Subjects with a baseline exhaled NO level greater than or equal to 25 ppb~Receive L-arginine first, then Placebo~L-Arginine: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.~Placebo: Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients."
11144452|NCT01841281|FG002|Participant Flow|Low Exhaled Nitric Oxide (NO), Placebo First, Then L-Arginine|"Subjects with a baseline exhaled NO level less than or equal to 20 ppb~Receive Placebo first, then L-arginine~L-Arginine: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.~Placebo: Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients."
11144453|NCT01841281|FG003|Participant Flow|High Exhaled Nitric Oxide (NO), Placebo First, Then L-Arginine|"Subjects with a baseline exhaled NO level greater than or equal to 25 ppb~Receive L-arginine first, then Placebo~L-Arginine: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.~Placebo: Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients."
11144454|NCT01841281|OG000|Outcome|Low Exhaled Nitric Oxide (NO), L-Arginine First, Then Placebo|"Subjects with a baseline exhaled NO level less than or equal to 20 ppb~Receive L-arginine first, then Placebo~L-Arginine: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.~Placebo: Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients."
11144455|NCT01841281|OG001|Outcome|High Exhaled Nitric Oxide (NO), L-Arginine First, Then Placebo|"Subjects with a baseline exhaled NO level greater than or equal to 25 ppb~Receive L-arginine first, then Placebo~L-Arginine: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.~Placebo: Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients."
11144456|NCT01841281|OG002|Outcome|Low Exhaled Nitric Oxide (NO), Placebo First, Then L-Arginine|"Subjects with a baseline exhaled NO level less than or equal to 20 ppb~Receive Placebo first, then L-arginine~L-Arginine: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.~Placebo: Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients."
11144457|NCT01841281|OG003|Outcome|High Exhaled Nitric Oxide (NO), Placebo First, Then L-Arginine|"Subjects with a baseline exhaled NO level greater than or equal to 25 ppb~Receive L-arginine first, then Placebo~L-Arginine: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.~Placebo: Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients."
11144458|NCT01841281|EG000|Reported Event|Low Exhaled Nitric Oxide (NO) Phase 1, Treatment Arm|ow Exhaled Nitric Oxide (NO) Phase 1, L-Arginine arm
11144459|NCT01841281|EG001|Reported Event|Low Exhaled Nitric Oxide (NO) Phase 1, Placebo Arm|Low Exhaled Nitric Oxide (NO) Phase 1, placebo arm
11144460|NCT01841281|EG002|Reported Event|Low Exhaled Nitric Oxide (NO) Washout Phase|Low Exhaled Nitric Oxide (NO) Washout Phase
11144461|NCT01841281|EG003|Reported Event|Low Exhaled Nitric Oxide (NO) Phase 2, Treatment Arm|Low Exhaled Nitric Oxide (NO) Phase 2, L-Arginine arm
11144462|NCT01841281|EG004|Reported Event|Low Exhaled Nitric Oxide (NO) Phase 2, Placebo Arm|Low Exhaled Nitric Oxide (NO) Phase 2, placebo arm
11144463|NCT01841281|EG005|Reported Event|High Exhaled Nitric Oxide (NO) Phase 1, Treatment Arm|High Exhaled Nitric Oxide (NO) Phase 1, L-Arginine arm
11144464|NCT01841281|EG006|Reported Event|High Exhaled Nitric Oxide (NO) Phase 1, Placebo Arm|High Exhaled Nitric Oxide (NO) Phase 1, placebo arm
11144465|NCT01841281|EG007|Reported Event|High Exhaled Nitric Oxide (NO) Washout Phase|High Exhaled Nitric Oxide (NO) Washout Phase
11144466|NCT01841281|EG008|Reported Event|High Exhaled Nitric Oxide (NO) Phase 2, Treatment Arm|High Exhaled Nitric Oxide (NO) Phase 2, L-Arginine arm
11144467|NCT01841281|EG009|Reported Event|High Exhaled Nitric Oxide (NO) Phase 2, Placebo Arm|igh Exhaled Nitric Oxide (NO) Phase 2, Placebo arm
11144468|NCT01841554|BG000|Baseline|Single|Multi-center, prospective study with intra-subject comparisons
11144469|NCT01841554|FG000|Participant Flow|Single|Multi-center, prospective study with intra-subject comparisons
11144470|NCT01841554|OG000|Outcome|Single|Multi-center, prospective study with intra-subject comparisons
11144471|NCT01841554|EG000|Reported Event|Single|Multi-center, prospective study with intra-subject comparisons
11144472|NCT01841567|BG000|Baseline|Dressing|"Mepilex border post. op~Mepilex border post op"
11144473|NCT01841567|FG000|Participant Flow|Dressing|"Mepilex border post. op~Mepilex border post op"
11144474|NCT01841567|OG000|Outcome|Dressing|"Mepilex border post. op~Mepilex border post op"
11144475|NCT01841567|EG000|Reported Event|Dressing|"Mepilex border post. op~Mepilex border post op"
11144476|NCT01841593|BG000|Baseline|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
11144477|NCT01841593|BG001|Baseline|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
11144478|NCT01841593|BG002|Baseline|Total|Total of all reporting groups
11144479|NCT01841593|FG000|Participant Flow|Group A (Raltegravir Then Amlodipine)|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
11224681|NCT02362412|EG000|Reported Event|Treatment Period II FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks).
11144480|NCT01841593|FG001|Participant Flow|Group B (Amlodipine Then Raltegravir)|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
11144481|NCT01841593|OG000|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
11144482|NCT01841593|OG001|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
11144483|NCT01841593|OG002|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
11144484|NCT01841593|OG003|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
11144485|NCT01841593|OG000|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
11144486|NCT01841593|OG001|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
11144487|NCT01841593|EG000|Reported Event|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
11144488|NCT01841593|EG001|Reported Event|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
11144489|NCT01841606|BG000|Baseline|Ondansetron|4mg IV Ondansetron
11144490|NCT01841606|BG001|Baseline|Placebo|10mL IV normal saline
11144491|NCT01841606|BG002|Baseline|Total|Total of all reporting groups
11144492|NCT01841606|FG000|Participant Flow|Ondansetron|Patients receiving pre-spinal ondansetron
11144493|NCT01841606|FG001|Participant Flow|Placebo|Patients receiving placebo
11144494|NCT01841606|OG000|Outcome|Ondansetron|Patients receiving pre-spinal ondansetron
11144495|NCT01841606|OG001|Outcome|Placebo|Patients receiving placebo
11144496|NCT01841606|EG000|Reported Event|Ondansetron|Patients receiving pre-spinal ondansetron
11144497|NCT01841606|EG001|Reported Event|Placebo|Patients receiving placebo
11144498|NCT01841619|BG000|Baseline|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
11144499|NCT01841619|FG000|Participant Flow|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
11144500|NCT01841619|OG000|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
11144501|NCT01841619|EG000|Reported Event|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
11144502|NCT01841632|BG000|Baseline|MultiStem - Cohort 1|"Cohort 1~Drug: MultiStem, Dose 1 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)"
11144503|NCT01841632|FG000|Participant Flow|MultiStem - Cohort 1|"Cohort 1~Drug: MultiStem, Dose 1 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)"
11144504|NCT01841632|OG000|Outcome|MultiStem - Cohort 1|"Cohort 1~Drug: MultiStem, Dose 1 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)"
11144505|NCT01841632|EG000|Reported Event|MultiStem - Cohort 1|"Cohort 1~Drug: MultiStem, Dose 1 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)"
11144506|NCT01841697|BG000|Baseline|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
11224682|NCT02362412|EG001|Reported Event|Treatment Period II FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily duringr Treatment Period II (8 weeks).
11144507|NCT01841697|BG001|Baseline|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
11144508|NCT01841697|BG002|Baseline|Total|Total of all reporting groups
11144509|NCT01841697|FG000|Participant Flow|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
11144510|NCT01841697|FG001|Participant Flow|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
11144511|NCT01841697|OG000|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
11144512|NCT01841697|OG001|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
11144513|NCT01841697|EG000|Reported Event|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
11144514|NCT01841697|EG001|Reported Event|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
11144515|NCT01841762|BG000|Baseline|Macitentan|Macitentan tablet, dose of 10 mg, once daily
11144516|NCT01841762|FG000|Participant Flow|Macitentan|Macitentan tablet, dose of 10 mg, once daily
11144517|NCT01841762|OG000|Outcome|Macitentan|Macitentan tablet, dose of 10 mg, once daily
11144518|NCT01841762|EG000|Reported Event|Macitentan|Macitentan tablet, dose of 10 mg, once daily
11144519|NCT01841970|BG000|Baseline|HET Arm|"Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids~HET Bipolar System: The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply."
11144520|NCT01841970|FG000|Participant Flow|HET Arm|All subjects enrolled into the study were treated with the HET Bipolar System
11144521|NCT01841970|OG000|Outcome|HET Arm|
11144522|NCT01841970|OG000|Outcome|Month 1|
11144523|NCT01841970|OG001|Outcome|Month 3|
11144524|NCT01841970|OG002|Outcome|Month 6|
11144525|NCT01841970|EG000|Reported Event|HET Arm|
11144526|NCT01842061|BG000|Baseline|Active Living Program|"Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.~Active Living Program"
11144527|NCT01842061|BG001|Baseline|Education|"Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.~Education"
11144528|NCT01842061|BG002|Baseline|Total|Total of all reporting groups
11144529|NCT01842061|FG000|Participant Flow|Active Living Program|"Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.~Active Living Program"
11144530|NCT01842061|FG001|Participant Flow|Education|"Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.~Education"
11144531|NCT01842061|OG000|Outcome|Active Living Program|"Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.~Active Living Program"
11144532|NCT01842061|OG001|Outcome|Education|"Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.~Education"
11144533|NCT01842061|EG000|Reported Event|Active Living Program|"Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.~Active Living Program"
11144534|NCT01842061|EG001|Reported Event|Education|"Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.~Education"
11144535|NCT01842308|BG000|Baseline|Phase 1; Dose Level 3|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144536|NCT01842308|BG001|Baseline|Phase 1; Dose Level 2|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144537|NCT01842308|BG002|Baseline|Phase 1; Dose Level 1|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144538|NCT01842308|BG003|Baseline|Phase 1; Dose Level 0|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144539|NCT01842308|BG004|Baseline|Phase 2|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144540|NCT01842308|BG005|Baseline|Total|Total of all reporting groups
11144541|NCT01842308|FG000|Participant Flow|Phase 1: Dose Level 3|CONDITIONING: Patients receive 56 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144542|NCT01842308|FG001|Participant Flow|Phase 1: Dose Level 2|CONDITIONING: Patients receive 45 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144543|NCT01842308|FG002|Participant Flow|Phase 1: Dose Level 1|CONDITIONING: Patients receive 36 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144544|NCT01842308|FG003|Participant Flow|Phase 1: Dose Level 0|CONDITIONING: Patients receive 27 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144545|NCT01842308|FG004|Participant Flow|Phase 2: Dose Level 3|CONDITIONING: Patients receive 56 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144546|NCT01842308|OG000|Outcome|Phase 1: Dose Level 3|CONDITIONING: Patients receive 56 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144547|NCT01842308|OG001|Outcome|Phase 1: Dose Level 2|CONDITIONING: Patients receive 45 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144548|NCT01842308|OG002|Outcome|Phase 1: Dose Level 1|CONDITIONING: Patients receive 36 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144549|NCT01842308|OG003|Outcome|Phase 1: Dose Level 0|CONDITIONING: Patients receive 27 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144550|NCT01842308|OG000|Outcome|Dose Level 3|CONDITIONING: Patients receive 56 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144551|NCT01842308|OG004|Outcome|Phase 2: Dose Level 3|CONDITIONING: Patients receive 56 mg/m^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144552|NCT01842308|EG000|Reported Event|Phase 1; Dose Level 3|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144553|NCT01842308|EG001|Reported Event|Phase 1; Dose Level 2|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144554|NCT01842308|EG002|Reported Event|Phase 1; Dose Level 1|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144555|NCT01842308|EG003|Reported Event|Phase 1; Dose Level 0|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144556|NCT01842308|EG004|Reported Event|Phase 2|CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
11144557|NCT01842334|BG000|Baseline|D-cycloserine|"250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.~Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.~Nicotine Replacement Therapy: NRT administered to both DCS and placebo group."
11144558|NCT01842334|BG001|Baseline|Placebo|"one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy~Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.~Nicotine Replacement Therapy: NRT administered to both DCS and placebo group."
11144559|NCT01842334|BG002|Baseline|Total|Total of all reporting groups
11144560|NCT01842334|FG000|Participant Flow|D-cycloserine|"250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.~Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.~Nicotine Replacement Therapy: NRT administered to both DCS and placebo group."
11144561|NCT01842334|FG001|Participant Flow|Placebo|"one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy~Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.~Nicotine Replacement Therapy: NRT administered to both DCS and placebo group."
11144562|NCT01842334|OG000|Outcome|D-cycloserine|"250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.~Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.~Nicotine Replacement Therapy: NRT administered to both DCS and placebo group."
11144563|NCT01842334|OG001|Outcome|Placebo|"one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy~Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.~Nicotine Replacement Therapy: NRT administered to both DCS and placebo group."
11144564|NCT01842334|EG000|Reported Event|D-cycloserine|"250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.~Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.~Nicotine Replacement Therapy: NRT administered to both DCS and placebo group."
11144565|NCT01842334|EG001|Reported Event|Placebo|"one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy~Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.~Nicotine Replacement Therapy: NRT administered to both DCS and placebo group."
11144566|NCT01842438|BG000|Baseline|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
11144567|NCT01842438|BG001|Baseline|Control|This group will not receive the intervention during the life-span of the project
11144568|NCT01842438|BG002|Baseline|Total|Total of all reporting groups
11144569|NCT01842438|FG000|Participant Flow|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
11144570|NCT01842438|FG001|Participant Flow|Control|This group will not receive the intervention during the life-span of the project
11144571|NCT01842438|OG000|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
11144572|NCT01842438|OG001|Outcome|Control|This group will not receive the intervention during the life-span of the project
11144573|NCT01842438|OG000|Outcome|Behavioral: Psychosexual Intervention PATIENTS|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention~This data is patients-only (all males)"
11144574|NCT01842438|OG001|Outcome|Intervention: Partners|This group received the intervention during the life-span of the project. Partners only.
11144575|NCT01842438|OG002|Outcome|Control: Patient Group|Did not receive the intervention. All males
11144576|NCT01842438|OG003|Outcome|Control: Partners|Did not receive the intervention; mostly females, but one male as there was one same-sex couple participating.
11144577|NCT01842438|EG000|Reported Event|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
11144578|NCT01842438|EG001|Reported Event|Control|This group will not receive the intervention during the life-span of the project
11144579|NCT01842464|BG000|Baseline|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
11144580|NCT01842464|FG000|Participant Flow|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
11144581|NCT01842464|OG000|Outcome|Anterior Sacro-Spinous Support|Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
11144582|NCT01842464|OG000|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
11144583|NCT01842464|EG000|Reported Event|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
11144584|NCT01842581|BG000|Baseline|Rifaximin 550 mg BID|Participants received rifaximin 550 mg tablet orally BID for 24 weeks.
11144585|NCT01842581|BG001|Baseline|Rifaximin 550 mg BID + Lactulose|Participants received rifaximin 550 mg tablet orally BID with lactulose solution for 24 weeks. Lactulose dose was self-titrated to produce 2 to 3 soft stools per day.
11144586|NCT01842581|BG002|Baseline|Total|Total of all reporting groups
11144587|NCT01842581|FG000|Participant Flow|Rifaximin 550 mg BID|Participants received rifaximin 550 milligrams (mg) tablet orally twice daily (BID) for 24 weeks.
11144588|NCT01842581|FG001|Participant Flow|Rifaximin 550 mg BID + Lactulose|Participants received rifaximin 550 mg tablet orally BID with lactulose solution for 24 weeks. Lactulose dose was self-titrated to produce 2 to 3 soft stools per day.
11144589|NCT01842581|OG000|Outcome|Rifaximin 550 mg BID|Participants received rifaximin 550 mg tablet orally BID for 24 weeks.
11144590|NCT01842581|OG001|Outcome|Rifaximin 550 mg BID + Lactulose|Participants received rifaximin 550 mg tablet orally BID with lactulose solution for 24 weeks. Lactulose dose was self-titrated to produce 2 to 3 soft stools per day.
11144591|NCT01842581|EG000|Reported Event|Rifaximin 550 mg BID|Participants received rifaximin 550 mg tablet orally BID for 24 weeks.
11144592|NCT01842581|EG001|Reported Event|Rifaximin 550 mg BID + Lactulose|Participants received rifaximin 550 mg tablet orally BID with lactulose solution for 24 weeks. Lactulose dose was self-titrated to produce 2 to 3 soft stools per day.
11144593|NCT01842594|BG000|Baseline|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
11144594|NCT01842594|FG000|Participant Flow|Sirolimus and Hydroxychloroquine|Patients received 1 mg of sirolimus (rapamycin, Rapa) and 200 mg of hydroxychloroquine (HCQ) twice a day before a meal for 2 weeks.
11144595|NCT01842594|OG000|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
11144596|NCT01842594|EG000|Reported Event|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
11144597|NCT01842607|BG000|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
11144598|NCT01842607|FG000|Participant Flow|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
11144599|NCT01842607|OG000|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
11144600|NCT01842607|EG000|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
11144601|NCT01842620|BG000|Baseline|Total Population|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day and single oral metformin (GLAFORNIL) 500 mg BID for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug
11224683|NCT02362412|EG002|Reported Event|Treatment Period III FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks).
11224684|NCT02362412|EG003|Reported Event|Treatment Period III FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks).
11144602|NCT01842620|FG000|Participant Flow|OXEMET Then GLAFORNIL|Eligible participants received single oral metformin (OXEMET) 1000 milligrams (mg) for one day in Treatment period 1 and was followed by 7 days washout period. Participants then received single oral metformin (GLAFORNIL) 500 mg twice daily (BID) for one day in Treatment period 2, followed by 7 days follow-up period. The two treatment periods were separated by a washout period of 7 days and participants received the study drugs in a randomized manner.
11144603|NCT01842620|FG001|Participant Flow|GLAFORNIL Then OXEMET|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day in Treatment period 1 and was followed by 7 days washout period. Participants then received single oral metformin (OXEMET) 1000 mg for one day in Treatment period 2, followed by 7 days follow-up period. The two treatment periods were separated by a washout period of 7 days and participants received the study drugs in a randomized manner.
11144604|NCT01842620|OG000|Outcome|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
11144605|NCT01842620|OG001|Outcome|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
11144606|NCT01842620|EG000|Reported Event|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 milligrams (mg) for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
11144607|NCT01842620|EG001|Reported Event|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 milligrams (mg) twice daily (BID) for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
11144608|NCT01842633|BG000|Baseline|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounces of water
11144609|NCT01842633|BG001|Baseline|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water
11144610|NCT01842633|BG002|Baseline|Placebo Caplets|Participants were administered with four placebo caplets orally with 8 ounces of water
11144611|NCT01842633|BG003|Baseline|Total|Total of all reporting groups
11144612|NCT01842633|FG000|Participant Flow|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65milligram (mg) plus 2 placebo caplets orally with 8 ounces of water
11144613|NCT01842633|FG001|Participant Flow|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water
11144614|NCT01842633|FG002|Participant Flow|Placebo Caplets|Participants were administered with four placebo caplets with 8 ounces of water
11144615|NCT01842633|OG000|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
11144616|NCT01842633|OG001|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
11144617|NCT01842633|OG002|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
11144618|NCT01842633|OG000|Outcome|Paracetamol/ Caffiene Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
11144619|NCT01842633|OG000|Outcome|Paracetamol/Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
11144620|NCT01842633|EG000|Reported Event|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounce of water
10850958|NCT03410992|OG000|Outcome|Placebo Escape (ESS)|Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS).
11144621|NCT01842633|EG001|Reported Event|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounce of water
11144622|NCT01842633|EG002|Reported Event|Placebo Caplets|Participants were administered with four placebo caplets orally with 8 ounce of water
11144623|NCT01842646|BG000|Baseline|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
11144624|NCT01842646|FG000|Participant Flow|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
11144625|NCT01842646|OG000|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
11144626|NCT01842646|EG000|Reported Event|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
11144627|NCT01842789|BG000|Baseline|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144628|NCT01842789|BG001|Baseline|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144629|NCT01842789|BG002|Baseline|Total|Total of all reporting groups
11144630|NCT01842789|FG000|Participant Flow|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144631|NCT01842789|FG001|Participant Flow|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144632|NCT01842789|OG000|Outcome|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144633|NCT01842789|OG000|Outcome|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144634|NCT01842789|OG001|Outcome|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144635|NCT01842789|EG000|Reported Event|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144636|NCT01842789|EG001|Reported Event|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
11144637|NCT01842815|BG000|Baseline|755nm Alexandrite Laser|"755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos~755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos."
11144638|NCT01842815|FG000|Participant Flow|755nm Alexandrite Laser|"755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos~755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos."
11144639|NCT01842815|OG000|Outcome|755nm Alexandrite Laser Single Pass (Right Side).|"755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit.~755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos."
11144640|NCT01842815|OG001|Outcome|755nm Alexandrite Laser Double Pass (Left Side)|"755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart.~755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos."
11144641|NCT01842815|EG000|Reported Event|755nm Alexandrite Laser|"755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos~755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos."
11144642|NCT01842841|BG000|Baseline|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
11144643|NCT01842841|FG000|Participant Flow|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 units per kilogram (U/kg), every other week (EOW) administered as an intravenous (IV) infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
11144644|NCT01842841|OG000|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
11144645|NCT01842841|EG000|Reported Event|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
11144646|NCT01842906|BG000|Baseline|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
11144647|NCT01842906|BG001|Baseline|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
11144648|NCT01842906|BG002|Baseline|Total|Total of all reporting groups
11144649|NCT01842906|FG000|Participant Flow|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
10879754|NCT00459667|OG002|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
11144650|NCT01842906|FG001|Participant Flow|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
11144651|NCT01842906|OG000|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
11144652|NCT01842906|OG001|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
11144653|NCT01842906|EG000|Reported Event|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
11144654|NCT01842906|EG001|Reported Event|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
11144655|NCT01842958|BG000|Baseline|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
11144656|NCT01842958|BG001|Baseline|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
11144657|NCT01842958|BG002|Baseline|Total|Total of all reporting groups
11144658|NCT01842958|FG000|Participant Flow|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implant, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
11144659|NCT01842958|FG001|Participant Flow|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implant, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
11144660|NCT01842958|OG000|Outcome|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
11144661|NCT01842958|OG001|Outcome|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
11144662|NCT01842958|EG000|Reported Event|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
11144663|NCT01842958|EG001|Reported Event|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
11224685|NCT02362425|BG000|Baseline|RYR1-RM Volunteers|All participants with RYR1-RM enrolled into the natural history period of the trial.
11144664|NCT01843023|BG000|Baseline|Extended Release Naltrexone|"Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.~Extended Release Naltrexone: naltrexone for extended release injectable suspension~Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community."
11144665|NCT01843023|BG001|Baseline|Treatment as Usual|"Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.~Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.~Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study."
11144666|NCT01843023|BG002|Baseline|Total|Total of all reporting groups
11144667|NCT01843023|FG000|Participant Flow|Extended Release Naltrexone|"Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.~Extended Release Naltrexone: naltrexone for extended release injectable suspension~Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community."
11144668|NCT01843023|FG001|Participant Flow|Treatment as Usual|"Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.~Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.~Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study."
11144669|NCT01843023|OG000|Outcome|Extended Release Naltrexone|"Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.~Extended Release Naltrexone: naltrexone for extended release injectable suspension~Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community."
11144670|NCT01843023|OG001|Outcome|Treatment as Usual|"Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.~Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.~Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study."
11144671|NCT01843023|EG000|Reported Event|Extended Release Naltrexone|"Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.~Extended Release Naltrexone: naltrexone for extended release injectable suspension~Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community."
11144672|NCT01843023|EG001|Reported Event|Treatment as Usual|"Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.~Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.~Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study."
11144673|NCT01843062|BG000|Baseline|Selumetinib 75 mg BD + RAI|Patients received selumetinib (75 mg, orally BD), for a period of approximately 5 weeks. Selumetinib was to be started approximately 4 weeks prior to the planned day of RAI therapy administered as a single oral dose of 100 mCi. To stimulate iodide uptake, patients received a rhTSH injection for each of the 2 days immediately prior to RAI therapy.
11144674|NCT01843062|BG001|Baseline|Placebo + RAI|Patients received placebo capsules (to match selumetinib, orally BD), for a period of approximately 5 weeks. Placebo was to be started approximately 4 weeks prior to the planned day of RAI therapy administered as a single oral dose of 100 mCi. To stimulate iodide uptake, patients received a rhTSH injection for each of the 2 days immediately prior to RAI therapy.
11144675|NCT01843062|BG002|Baseline|Total|Total of all reporting groups
11224686|NCT02362425|BG001|Baseline|Healthy Volunteers|Healthy volunteers were evaluated to determine normal values of biomarkers, muscle ultrasound, and near infrared spectroscopy in this rare disease, in order to develop a comparison between healthy and RYR1-RM individuals.
11144676|NCT01843062|FG000|Participant Flow|Selumetinib 75 mg BD + RAI|Patients received selumetinib (75 milligrams [mg], orally twice daily [BD]), for a period of approximately 5 weeks. Selumetinib was to be started approximately 4 weeks prior to the planned day of RAI therapy administered as a single oral dose of 100 millicuries (mCi). To stimulate iodide uptake, patients received a recombinant human thyroid stimulating hormone (rhTSH) injection for each of the 2 days immediately prior to RAI therapy.
11144677|NCT01843062|FG001|Participant Flow|Placebo + RAI|Patients received placebo capsules (to match selumetinib, orally BD), for a period of approximately 5 weeks. Placebo was to be started approximately 4 weeks prior to the planned day of RAI therapy administered as a single oral dose of 100 mCi. To stimulate iodide uptake, patients received a rhTSH injection for each of the 2 days immediately prior to RAI therapy.
11144678|NCT01843062|OG000|Outcome|Selumetinib 75 mg BD + RAI|Patients received selumetinib (75 mg, orally BD), for a period of approximately 5 weeks. Selumetinib was to be started approximately 4 weeks prior to the planned day of RAI therapy administered as a single oral dose of 100 mCi. To stimulate iodide uptake, patients received a rhTSH injection for each of the 2 days immediately prior to RAI therapy.
11144679|NCT01843062|OG001|Outcome|Placebo + RAI|Patients received placebo capsules (to match selumetinib, orally BD), for a period of approximately 5 weeks. Placebo was to be started approximately 4 weeks prior to the planned day of RAI therapy administered as a single oral dose of 100 mCi. To stimulate iodide uptake, patients received a rhTSH injection for each of the 2 days immediately prior to RAI therapy.
11144680|NCT01843062|EG000|Reported Event|Selumetinib 75 mg BD + RAI|Patients received selumetinib (75 mg, orally BD), for a period of approximately 5 weeks. Selumetinib was to be started approximately 4 weeks prior to the planned day of RAI therapy administered as a single oral dose of 100 mCi. To stimulate iodide uptake, patients received a rhTSH injection for each of the 2 days immediately prior to RAI therapy.
11144681|NCT01843062|EG001|Reported Event|Placebo + RAI|Patients received placebo capsules (to match selumetinib, orally BD), for a period of approximately 5 weeks. Placebo was to be started approximately 4 weeks prior to the planned day of RAI therapy administered as a single oral dose of 100 mCi. To stimulate iodide uptake, patients received a rhTSH injection for each of the 2 days immediately prior to RAI therapy.
11144682|NCT01843192|BG000|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection
11144683|NCT01843192|BG001|Baseline|Lobectomy|Subjects undergoing VATS lobectomy
11144684|NCT01843192|BG002|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
11144685|NCT01843192|BG003|Baseline|Total|Total of all reporting groups
11144686|NCT01843192|FG000|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection
11144687|NCT01843192|FG001|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy
11144688|NCT01843192|FG002|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
11144689|NCT01843192|OG000|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
11144690|NCT01843192|OG001|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
11144691|NCT01843192|OG002|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
11144692|NCT01843192|EG000|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
11144693|NCT01843192|EG001|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
10879755|NCT00459667|EG000|Reported Event|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
11144694|NCT01843192|EG002|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
11144695|NCT01843205|BG000|Baseline|Completing Participants|All subjects who completed the study.
11144696|NCT01843205|FG000|Participant Flow|Placebo Then Buspirone|Subjects were maintained on placebo for 7 days, then they were crossed over to 45 mg buspirone daily for 7 days.
11144697|NCT01843205|FG001|Participant Flow|Buspirone Then Placebo|Subjects were maintained on 45 mg buspirone daily for 7 days, then they were crossed over to placebo for 7 days.
11144698|NCT01843205|OG000|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
11144699|NCT01843205|OG001|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
11144700|NCT01843205|EG000|Reported Event|Placebo|All completing subjects who received placebo maintenance.
11144701|NCT01843205|EG001|Reported Event|Buspirone|All completing subjects who received buspirone maintenance.
11144702|NCT01843348|BG000|Baseline|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
11144703|NCT01843348|BG001|Baseline|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
11144704|NCT01843348|BG002|Baseline|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
11144705|NCT01843348|BG003|Baseline|Total|Total of all reporting groups
11144706|NCT01843348|FG000|Participant Flow|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
11144707|NCT01843348|FG001|Participant Flow|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
11144708|NCT01843348|FG002|Participant Flow|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
11144709|NCT01843348|OG000|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
11144710|NCT01843348|OG001|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
11144711|NCT01843348|OG002|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
11144712|NCT01843348|OG003|Outcome|Tac+Certican - Tac+MPA - Difference Between Groups|
11144713|NCT01843348|OG004|Outcome|CycA+Certican -Tac+MPA - Difference Between Groups|
11144714|NCT01843348|EG000|Reported Event|Tac+MPA|Tac+MPA
11144715|NCT01843348|EG001|Reported Event|Tac+Certican|Tac+Certican
11144716|NCT01843348|EG002|Reported Event|CycA+Certican|CycA+Certican
11144717|NCT01843465|BG000|Baseline|Cryoablation of Atrial Fibrillation|Maneuvers for documenting the disconnection :
11224687|NCT02362425|BG002|Baseline|RYR1-RM Volunteers: N-acetylcysteine (NAC)|N-acetylcysteine (NAC) 900 mg tablets; week 1 up to 1800 mg/day; Week 2- through end of study based on participant weight: < 50 kg subjects up to 2700 mg/day, >50 kg subjects 2700 mg/day
11224688|NCT02362425|BG003|Baseline|RYR1-RM Volunteers :Placebo|Placebo 900 mg tablets identical but did not contain NAC
11144718|NCT01843465|FG000|Participant Flow|Cryoablation of Atrial Fibrillation|"All patients underwent cryoballoon ablation of atrial fibrillation using the Achieve 20mm catheter for real-time documentation of PV potentials.~According to the maneuvers for documenting the disconnection , 4 PV types were defined:~Type 1 - Achieve allowing documentation of PV disconnection in the standard position.~Type 2 - Need of backward/proximal displacement of the Achieve catheter to display PV potentials during cryoenergy application.~Type 3 - No possibility of clear documentation of PV potentials, but capture of PV with pacing Type 4 - no real-time documentation of PV disconnection"
11144719|NCT01843465|OG000|Outcome|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :~Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
11144720|NCT01843465|EG000|Reported Event|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :~Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
11144721|NCT01843621|BG000|Baseline|Total Vaccinated|"The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003~DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4)."
11144722|NCT01843621|FG000|Participant Flow|Total Vaccinated|"The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003~DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4)."
11144723|NCT01843621|OG000|Outcome|> 10 ED50|Seropositivity rates (% of subjects)
11144724|NCT01843621|OG000|Outcome|Geometric Mean Titer (GMT)|Geometric mean antibody titer value
11144725|NCT01843621|OG000|Outcome|Total Vaccinated|"The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003~DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4)."
11144726|NCT01843621|OG000|Outcome|Ratio IgM and IgG|Ratio of Dengue (DEN) IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG (ATP cohort for immunogenicity)
11144727|NCT01843621|OG000|Outcome|ALT Level|Normal Range = 0-30
10879756|NCT00459667|EG001|Reported Event|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
11144728|NCT01843621|OG001|Outcome|AST Level|Normal Range = 0-40
11144729|NCT01843621|OG002|Outcome|PLA Level|Normal Range = 150000-350000
11144730|NCT01843621|OG003|Outcome|HC Level|Normal Range = 35-45
11144731|NCT01843621|OG004|Outcome|NEU Level|Normal Range = 1500-8000
11144732|NCT01843621|EG000|Reported Event|Total Vaccinated|"The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003~DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4)."
11144733|NCT01843660|BG000|Baseline|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
11144734|NCT01843660|FG000|Participant Flow|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
11144735|NCT01843660|OG000|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
11144736|NCT01843660|EG000|Reported Event|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
11144737|NCT01843673|BG000|Baseline|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT~cone-beam computed tomography: Undergo dual CBCT~radiography: Undergo 2-D x-ray with Varian kV OBI~radiography: Undergo 2-D x-ray with Brain Lab ExacTrac~radiography: Undergo 2-D x-ray with Varian MV OBI~electronic portal imaging: Undergo EPID imaging~image-guided adaptive radiation therapy: Undergo IGART"
11144738|NCT01843673|FG000|Participant Flow|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART"
11224689|NCT02362425|BG004|Baseline|Total|Total of all reporting groups
11224690|NCT02362425|FG000|Participant Flow|RYR1-RM Volunteers|Subjects with RYR1-RM entered into the Natural History Phase of the study.
11144739|NCT01843673|OG000|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
11144740|NCT01843673|OG001|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
11144741|NCT01843673|OG002|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
11144742|NCT01843673|EG000|Reported Event|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT~cone-beam computed tomography: Undergo dual CBCT~radiography: Undergo 2-D x-ray with Varian kV OBI~radiography: Undergo 2-D x-ray with Brain Lab ExacTrac~radiography: Undergo 2-D x-ray with Varian MV OBI~electronic portal imaging: Undergo EPID imaging~image-guided adaptive radiation therapy: Undergo IGART"
11144743|NCT01843751|BG000|Baseline|Physician Office|"Buprenorphine/naloxone via physician office (B-PO) x 10 months~buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system."
11144744|NCT01843751|BG001|Baseline|Specialist Center|"Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.~buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system."
11144745|NCT01843751|BG002|Baseline|Total|Total of all reporting groups
11144746|NCT01843751|FG000|Participant Flow|Physician Office|"Buprenorphine/naloxone via physician office (B-PO) x 10 months~buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system."
11144747|NCT01843751|FG001|Participant Flow|Specialist Center|"Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.~buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system."
11144748|NCT01843751|OG000|Outcome|Physician Office|"Buprenorphine/naloxone via physician office (B-PO) x 10 months~buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system."
11144749|NCT01843751|OG001|Outcome|Specialist Center|"Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.~buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system."
11144750|NCT01843751|EG000|Reported Event|Physician Office|"Buprenorphine/naloxone via physician office (B-PO) x 10 months~buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system."
11144751|NCT01843751|EG001|Reported Event|Specialist Center|"Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.~buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system."
11224691|NCT02362425|FG001|Participant Flow|Healthy Volunteers|Healthy volunteers entered into the study for a one-visit assessment; no treatment given.
11144752|NCT01843777|BG000|Baseline|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
11144753|NCT01843777|BG001|Baseline|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
11144754|NCT01843777|BG002|Baseline|Total|Total of all reporting groups
11144755|NCT01843777|FG000|Participant Flow|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
11144756|NCT01843777|FG001|Participant Flow|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
11144757|NCT01843777|OG000|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
11144758|NCT01843777|OG001|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
11144759|NCT01843777|EG000|Reported Event|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
11144760|NCT01843777|EG001|Reported Event|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
11144761|NCT01843803|BG000|Baseline|Patient Inventory|"prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery~patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit."
11144762|NCT01843803|BG001|Baseline|Attention Control|"prior to the encounter, the patient will view a brief video containing general health information.~attention control: Patients will view a brief healthy living video on an iPad"
11144763|NCT01843803|BG002|Baseline|Total|Total of all reporting groups
11144764|NCT01843803|FG000|Participant Flow|Patient Inventory|"prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery~patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit."
11144765|NCT01843803|FG001|Participant Flow|Attention Control|"prior to the encounter, the patient will view a brief video containing general health information.~attention control: Patients will view a brief healthy living video on an iPad"
11144766|NCT01843803|OG000|Outcome|Patient Inventory|"prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery~patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit."
11144767|NCT01843803|OG001|Outcome|Attention Control|"prior to the encounter, the patient will view a brief video containing general health information.~attention control: Patients will view a brief healthy living video on an iPad"
11144768|NCT01843803|EG000|Reported Event|Patient Inventory|"prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery~patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit."
11144769|NCT01843803|EG001|Reported Event|Attention Control|"prior to the encounter, the patient will view a brief video containing general health information.~attention control: Patients will view a brief healthy living video on an iPad"
11144770|NCT01843842|BG000|Baseline|Ergoferon in Liquid Dosage Form|1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day
11144771|NCT01843842|BG001|Baseline|Placebo|1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day
11144772|NCT01843842|BG002|Baseline|Total|Total of all reporting groups
11224692|NCT02362425|FG002|Participant Flow|RYR1-RM Volunteers: N-acetylcysteine (NAC)|RYR1-RM subjects who were eventually randomized to NAC 900 mg tablets
11224693|NCT02362425|FG003|Participant Flow|RYR1-RM Volunteers: Placebo|RYR1-RM subjects who were eventually randomized to Placebo 900 mg tablets without active NAC
10850959|NCT03410992|OG001|Outcome|Bimekizumab 320 mg Q4W Escape (ESS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
11144773|NCT01843842|FG000|Participant Flow|Ergoferon in Liquid Dosage Form|Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
11144774|NCT01843842|FG001|Participant Flow|Placebo|Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
11144775|NCT01843842|OG000|Outcome|Ergoferon in Liquid Dosage Form|Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
11144776|NCT01843842|OG001|Outcome|Placebo|Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
11144777|NCT01843842|EG000|Reported Event|Ergoferon in Liquid Dosage Form|Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
11144778|NCT01843842|EG001|Reported Event|Placebo|Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
11144779|NCT01843920|BG000|Baseline|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
11144780|NCT01843920|BG001|Baseline|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
11144781|NCT01843920|BG002|Baseline|Total|Total of all reporting groups
11144782|NCT01843920|FG000|Participant Flow|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
11144783|NCT01843920|FG001|Participant Flow|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
10879757|NCT00459667|EG002|Reported Event|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
11144784|NCT01843920|OG000|Outcome|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
11144785|NCT01843920|OG001|Outcome|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
11144786|NCT01843920|EG000|Reported Event|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
11224694|NCT02362425|OG000|Outcome|N-acetylcysteine (NAC)|N-acetylcysteine (NAC) 900 mg tablets; week 1 up to 1800 mg/day; Week 2- through end of study based on subject weight: < 50 kg subjects up to 2700 mg/day, >50 kg subjects 2700 mg/day
10879758|NCT00459706|BG000|Baseline|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
10879759|NCT00459706|BG001|Baseline|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
11144787|NCT01843920|EG001|Reported Event|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
11144788|NCT01843933|BG000|Baseline|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
11144789|NCT01843933|BG001|Baseline|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
11144790|NCT01843933|BG002|Baseline|Total|Total of all reporting groups
11144791|NCT01843933|FG000|Participant Flow|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
11144792|NCT01843933|FG001|Participant Flow|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
11144793|NCT01843933|OG000|Outcome|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
11144794|NCT01843933|OG001|Outcome|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
11144795|NCT01843933|EG000|Reported Event|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
10879760|NCT00459706|BG002|Baseline|Total|Total of all reporting groups
11144796|NCT01843933|EG001|Reported Event|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
11144797|NCT01843972|BG000|Baseline|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
11144798|NCT01843972|BG001|Baseline|BI 691751dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
11144799|NCT01843972|BG002|Baseline|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
11144800|NCT01843972|BG003|Baseline|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
10879761|NCT00459706|FG000|Participant Flow|Enbrel 50 mg Autoinjector|Enbrel 50 milligram (mg) once weekly subcutaneously for 12 Weeks using autoinjector
11144801|NCT01843972|BG004|Baseline|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
11144802|NCT01843972|BG005|Baseline|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
11144803|NCT01843972|BG006|Baseline|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
11144804|NCT01843972|BG007|Baseline|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
11144805|NCT01843972|BG008|Baseline|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
11144806|NCT01843972|BG009|Baseline|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
11144807|NCT01843972|BG010|Baseline|Total|Total of all reporting groups
11144808|NCT01843972|FG000|Participant Flow|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
11144809|NCT01843972|FG001|Participant Flow|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
11144810|NCT01843972|FG002|Participant Flow|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
11144811|NCT01843972|FG003|Participant Flow|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
11144812|NCT01843972|FG004|Participant Flow|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
11144813|NCT01843972|FG005|Participant Flow|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
11144814|NCT01843972|FG006|Participant Flow|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
11144815|NCT01843972|FG007|Participant Flow|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
11144816|NCT01843972|FG008|Participant Flow|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
11144817|NCT01843972|FG009|Participant Flow|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
11144818|NCT01843972|OG000|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|"single dose given as 1 tablet; extensive metabolizers;~BI 691751: 1 tablet (10 mg)"
11144819|NCT01843972|OG001|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|"single dose given as 1 tablet; poor metabolizers;~BI 691751: 1 tablet (10 mg)"
11144820|NCT01843972|OG002|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
11144821|NCT01843972|OG000|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
11144822|NCT01843972|OG001|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
11144823|NCT01843972|OG000|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
11144824|NCT01843972|OG001|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
11144825|NCT01843972|OG002|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
11144826|NCT01843972|OG003|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
11144827|NCT01843972|OG004|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
11144828|NCT01843972|OG005|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
11144829|NCT01843972|OG006|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
11144830|NCT01843972|OG007|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
11144831|NCT01843972|OG007|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
11144832|NCT01843972|OG008|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
11144833|NCT01843972|OG009|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
11144834|NCT01843972|OG000|Outcome|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
11144835|NCT01843972|OG001|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
11144836|NCT01843972|OG002|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
11144837|NCT01843972|OG003|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
11144838|NCT01843972|OG004|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
11144839|NCT01843972|OG005|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
11144840|NCT01843972|OG006|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
11144841|NCT01843972|OG007|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
11144842|NCT01843972|EG000|Reported Event|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
11144843|NCT01843972|EG001|Reported Event|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
10879762|NCT00459706|FG001|Participant Flow|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
10879763|NCT00459706|OG000|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
11144844|NCT01843972|EG002|Reported Event|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
11144845|NCT01843972|EG003|Reported Event|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
11144846|NCT01843972|EG004|Reported Event|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
11144847|NCT01843972|EG005|Reported Event|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
11144848|NCT01843972|EG006|Reported Event|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
11144849|NCT01843972|EG007|Reported Event|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
11144850|NCT01843972|EG008|Reported Event|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
11144851|NCT01843972|EG009|Reported Event|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
11224695|NCT02362425|OG001|Outcome|Placebo|Placebo 900 mg tablets identical but did not contain NAC
11224696|NCT02362425|OG000|Outcome|RYR1-RM Volunteers|All participants with RYR1-RM enrolled into the natural history period of the trial.
11224697|NCT02362425|OG001|Outcome|Healthy Volunteer|Healthy volunteers who participated in a one-visit assessment.
11144852|NCT01844076|BG000|Baseline|Phase I Level -2|"Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.~Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.~Group 1: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle"
11144853|NCT01844076|BG001|Baseline|Phase I Level -1|Group 2: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
11144854|NCT01844076|BG002|Baseline|Phase I Level 0|Group 3: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
11144855|NCT01844076|BG003|Baseline|Phase II|"Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.~Patients will receive capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle"
11144856|NCT01844076|BG004|Baseline|Total|Total of all reporting groups
11144857|NCT01844076|FG000|Participant Flow|Phase I Level -2|"Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.~Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.~Group 1: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle"
11144858|NCT01844076|FG001|Participant Flow|Phase I Level -1|Group 2: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
11144859|NCT01844076|FG002|Participant Flow|Phase I Level 0|Group 3: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
11144860|NCT01844076|FG003|Participant Flow|Phase II|"Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.~Patients will receive capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle"
11144861|NCT01844076|OG000|Outcome|Phase I Level -2|"Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.~Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.~Group 1: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle"
11144862|NCT01844076|OG001|Outcome|Phase I Level -1|Group 2: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
11144863|NCT01844076|OG002|Outcome|Phase I Level 0|Group 3: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
11144864|NCT01844076|OG003|Outcome|Phase II|"Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.~Patients will receive capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle"
10850960|NCT03410992|OG002|Outcome|Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
11144865|NCT01844076|EG000|Reported Event|Phase I Level -2|"Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.~Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.~Group 1: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle"
11144866|NCT01844076|EG001|Reported Event|Phase I Level -1|Group 2: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle
11144867|NCT01844076|EG002|Reported Event|Phase I Level 0|Group 3: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
11144868|NCT01844076|EG003|Reported Event|Phase II|"Phase II will use the treatment outlined in phase I, using the RP2D derived from Phase I.~Patients will receive capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle"
11144869|NCT01844115|BG000|Baseline|Placebo|Dose-matched placebo tablets, oral administration
11144870|NCT01844115|BG001|Baseline|Vilazodone|Vilazodone tablets, oral administration
11144871|NCT01844115|BG002|Baseline|Total|Total of all reporting groups
11144872|NCT01844115|FG000|Participant Flow|Placebo|Dose-matched placebo tablets, oral administration
11144873|NCT01844115|FG001|Participant Flow|Vilazodone|Vilazodone tablets, oral administration
11144874|NCT01844115|OG000|Outcome|Placebo|Dose-matched placebo tablets, oral administration
11144875|NCT01844115|OG001|Outcome|Vilazodone|Vilazodone tablets, oral administration
11144876|NCT01844115|EG000|Reported Event|Placebo|Dose-matched placebo tablets, oral administration
11144877|NCT01844115|EG001|Reported Event|Vilazodone|Vilazodone tablets, oral administration
11144878|NCT01844193|BG000|Baseline|Standard Therapy|This arm of the study will follow the standard therapy course after total knee arthroplasty.
11144879|NCT01844193|BG001|Baseline|Standard Therapy + NMES|"This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device.~Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment (Warm-up, Work, Relaxation, and Recovery) for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated."
10879764|NCT00459706|OG001|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
11144880|NCT01844193|BG002|Baseline|Total|Total of all reporting groups
11144881|NCT01844193|FG000|Participant Flow|Standard Therapy|This arm of the study will follow the standard therapy course after total knee arthroplasty.
11144882|NCT01844193|FG001|Participant Flow|Standard Therapy + NMES|"This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device.~Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment (Warm-up, Work, Relaxation, and Recovery) for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated."
11144883|NCT01844193|OG000|Outcome|Standard Therapy|This arm of the study will follow the standard therapy course after total knee arthroplasty.
11144884|NCT01844193|OG001|Outcome|Standard Therapy + NMES|"This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device.~Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment (Warm-up, Work, Relaxation, and Recovery) for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated."
11144885|NCT01844193|EG000|Reported Event|Standard Therapy|This arm of the study will follow the standard therapy course after total knee arthroplasty.
11144886|NCT01844193|EG001|Reported Event|Standard Therapy + NMES|"This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device.~Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment (Warm-up, Work, Relaxation, and Recovery) for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated."
11144887|NCT01844284|BG000|Baseline|Absorb BVS|Subjects receiving Absorb BVS
11144888|NCT01844284|BG001|Baseline|XIENCE PRIME/XIENCE Xpedition|Subjects receiving XIENCE PRIME/XIENCE Xpedition
11144889|NCT01844284|BG002|Baseline|Total|Total of all reporting groups
11144890|NCT01844284|FG000|Participant Flow|Absorb BVS|Subjects receiving Absorb BVS
11144891|NCT01844284|FG001|Participant Flow|XIENCE PRIME/XIENCE Xpedition|Subjects receiving XIENCE PRIME/XIENCE Xpedition
10879765|NCT00459706|EG000|Reported Event|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
11144892|NCT01844284|OG000|Outcome|Absorb BVS|Subjects receiving Absorb BVS
11144893|NCT01844284|OG001|Outcome|XIENCE PRIME/XIENCE Xpedition|Subjects receiving XIENCE PRIME/XIENCE Xpedition
11144894|NCT01844284|EG000|Reported Event|Absorb BVS|Subjects receiving Absorb BVS
11144895|NCT01844284|EG001|Reported Event|XIENCE PRIME/XIENCE Xpedition|Subjects receiving XIENCE PRIME/XIENCE Xpedition
11144896|NCT01844375|BG000|Baseline|Carbohydrate Group|"The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.~Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning."
11144897|NCT01844375|BG001|Baseline|Control Group|"The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.~Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning."
10879766|NCT00459706|EG001|Reported Event|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
11144898|NCT01844375|BG002|Baseline|Total|Total of all reporting groups
11144899|NCT01844375|FG000|Participant Flow|Carbohydrate Group|"The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.~Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning."
11144900|NCT01844375|FG001|Participant Flow|Control Group|"The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.~Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning."
11144901|NCT01844375|OG000|Outcome|Carbohydrate Group|"The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.~Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning."
11144902|NCT01844375|OG001|Outcome|Control Group|"The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.~Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning."
11144903|NCT01844375|EG000|Reported Event|Carbohydrate Group|"The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.~Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning."
11144904|NCT01844375|EG001|Reported Event|Control Group|"The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.~Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning."
11144905|NCT01844388|BG000|Baseline|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
11144906|NCT01844388|BG001|Baseline|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
11144907|NCT01844388|BG002|Baseline|Total|Total of all reporting groups
11144908|NCT01844388|FG000|Participant Flow|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
11144909|NCT01844388|FG001|Participant Flow|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
11144910|NCT01844388|OG000|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
10879767|NCT00459732|BG000|Baseline|Zinc|25 mg of zinc as zn sulfate taken daily
11144911|NCT01844388|OG001|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
11144912|NCT01844388|EG000|Reported Event|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
11144913|NCT01844388|EG001|Reported Event|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
11224698|NCT02362425|OG001|Outcome|Healthy Volunteers|Healthy volunteers entered into the study for a one-visit assessment; no treatment given.
11224699|NCT02362425|EG000|Reported Event|RYR1-RM Volunteers|All participants with RYR1-RM enrolled into the natural history period of the trial
10879768|NCT00459732|BG001|Baseline|Placebo|daily capsule similar in size/color to zn was taken daily by this group
11144914|NCT01844479|BG000|Baseline|All Study Participants|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole~The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
11144915|NCT01844479|FG000|Participant Flow|Standard Innersole Followed by DFO|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole~DFO The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
11144916|NCT01844479|FG001|Participant Flow|Diabetic Foot Orthotic Followed by Standard Innersole|"The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
11144917|NCT01844479|OG000|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
11144918|NCT01844479|OG001|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
11144919|NCT01844479|OG000|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
11144920|NCT01844479|EG000|Reported Event|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
11144921|NCT01844479|EG001|Reported Event|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
11144922|NCT01844531|BG000|Baseline|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|"Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets).~Oral administration."
11144923|NCT01844531|BG001|Baseline|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|"Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC).~Oral administration."
11144924|NCT01844531|BG002|Baseline|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
11144925|NCT01844531|BG003|Baseline|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
11144926|NCT01844531|BG004|Baseline|Total|Total of all reporting groups
10879769|NCT00459732|BG002|Baseline|Total|Total of all reporting groups
11144927|NCT01844531|FG000|Participant Flow|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin Fixed Dose Combination (FDC)). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
11144928|NCT01844531|FG001|Participant Flow|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). Oral administration.
11144929|NCT01844531|FG002|Participant Flow|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
11144930|NCT01844531|FG003|Participant Flow|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
11144931|NCT01844531|OG000|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
11144932|NCT01844531|OG001|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
11144933|NCT01844531|OG002|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
11144934|NCT01844531|OG003|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
11144935|NCT01844531|EG000|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
11144936|NCT01844531|EG001|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
11144937|NCT01844531|EG002|Reported Event|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
11144938|NCT01844531|EG003|Reported Event|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
11144939|NCT01844583|BG000|Baseline|Esomeprazole 40 mg + Alisertib 50 mg|Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Esomeprazole, 40 mg, delayed-release capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).
11144940|NCT01844583|BG001|Baseline|Rifampin 600 mg + Alisertib 50 mg|Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Rifampin 600 mg, capsules, orally, once daily on Days 1 to 10 in Cycle 2 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).
11144941|NCT01844583|BG002|Baseline|Total|Total of all reporting groups
11144942|NCT01844583|FG000|Participant Flow|Esomeprazole 40 mg + Alisertib 50 mg|Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Esomeprazole, 40 mg, delayed-release capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).
11144943|NCT01844583|FG001|Participant Flow|Rifampin 600 mg + Alisertib 50 mg|Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Rifampin 600 mg, capsules, orally, once daily on Days 1 to 10 in Cycle 2 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).
11144944|NCT01844583|OG000|Outcome|Alisertib Without Esomeprazole|Alisertib 50 mg, tablets, orally, once on Day 1 in Cycle 1.
11144945|NCT01844583|OG001|Outcome|Alisertib With Esomeprazole|Esomeprazole 40 mg, capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17 in Cycle 2.
11144946|NCT01844583|OG000|Outcome|Alisertib Without Rifampin|Alisertib 50 mg, tablets, orally, once on Day 1 in Cycle 1.
11144947|NCT01844583|OG001|Outcome|Alisertib With Rifampin|Rifampin 600 mg, capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on up Days 11 to 17 in Cycle 2.
11144948|NCT01844583|OG000|Outcome|Alisertib|Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1.
11224700|NCT02362425|EG001|Reported Event|RYR1-RM Volunteers: N-acetylcysteine (NAC)|N-acetylcysteine (NAC) 900 mg tablets for 6 months; week 1 up to 1800 mg/day; Week 2- through end of study based on subject weight: < 50 kg subjects up to 2700 mg/day, >50 kg subjects 2700 mg/day
10879770|NCT00459732|FG000|Participant Flow|Zinc|25 mg of zinc as zn sulfate taken daily
11144949|NCT01844583|OG000|Outcome|Esomeprazole 40 mg + Alisertib 50 mg|Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Esomeprazole, 40 mg, delayed-release capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).
11144950|NCT01844583|OG001|Outcome|Rifampin 600 mg + Alisertib 50 mg|Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Rifampin 600 mg, capsules, orally, once daily on Days 1 to 10 in Cycle 2 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).
10879771|NCT00459732|FG001|Participant Flow|Placebo|daily capsule similar in size/color to zn was taken daily by this group
11144951|NCT01844583|EG000|Reported Event|Esomeprazole 40 mg + Alisertib 50 mg|"Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1.~Esomeprazole, 40 mg, delayed-release capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2.~Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles)."
11144952|NCT01844583|EG001|Reported Event|Rifampin 600 mg + Alisertib 50 mg|"Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1.~Rifampin 600 mg, capsules, orally, once daily on Days 1 to 10 in Cycle 2 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2.~Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles)."
11144953|NCT01844687|BG000|Baseline|Single Group|"Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol~A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion"
11144954|NCT01844687|FG000|Participant Flow|Single Group|"Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol~A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion"
11144955|NCT01844687|OG000|Outcome|Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)|a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
11144956|NCT01844687|OG001|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
11144957|NCT01844687|OG002|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
11144958|NCT01844687|OG003|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
11144959|NCT01844687|OG004|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
11144960|NCT01844687|OG005|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
11144961|NCT01844687|OG006|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
11144962|NCT01844687|OG007|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
11144963|NCT01844687|OG000|Outcome|Active MJ With 0 mg CBD|a placebo comparator measuring the effect of CBD on liking the effects of smoking 5.30% THC cannabis cigarettes
11144964|NCT01844687|OG000|Outcome|Active MJ With 0 mg CBD|a placebo comparator measuring the effect of CBD on the strength of effects of smoking 5.30% THC cannabis cigarettes
11144965|NCT01844687|OG000|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
11144966|NCT01844687|OG000|Outcome|Plasma CBD Concentrations|Eight of the 31 participants who completed the study came to a ninth session to receive 800 mg CBD and donate seven blood samples over six hours, one immediately before swallowing CBD capsules, and 6 throughout the next six hours. Plasma samples were analyzed through NIDA contract #NO1DA-14-7788 to David Moody, Ph.D.
11144967|NCT01844687|EG000|Reported Event|Active MJ With 0 mg CBD|31 subjects were tested with 0 mg CBD and an active marijuana cigarette.
11144968|NCT01844687|EG001|Reported Event|Active MJ With 200 mg CBD|31 subjects were tested with 200 mg CBD and an active marijuana cigarette.
10879772|NCT00459732|OG000|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
10879773|NCT00459732|OG001|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
10879774|NCT00459732|EG000|Reported Event|Zinc|25 mg of zinc as zn sulfate taken daily
11144969|NCT01844687|EG002|Reported Event|Active MJ With 400 mg CBD|31 subjects were tested with 400 mg CBD and an active marijuana cigarette.
11144970|NCT01844687|EG003|Reported Event|Active MJ With 800 mg CBD|31 subjects were tested with 800 mg CBD and an active MJ cigarette.
11144971|NCT01844687|EG004|Reported Event|Inactive MJ With 0 mg CBD|31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
11144972|NCT01844687|EG005|Reported Event|Inactive MJ With 200 mg CBD|31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
11144973|NCT01844687|EG006|Reported Event|Inactive MJ With 400 mg CBD|31 subjects were tested with 400 mg CBD and an inactive marijuana cigarette.
11144974|NCT01844687|EG007|Reported Event|Inactive MJ With 800 mg CBD|"31 subjects were tested with 800 mg CBD and Inactive MJ cigarette.~8 of the 31 study completers were given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion. No MJ cigarette was smoked during this session. Adverse events reported during this session are included here."
11144975|NCT01844700|BG000|Baseline|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 patients were randomized to Ziprasidone"
11144976|NCT01844700|BG001|Baseline|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 patients were randomized to usual care"
11144977|NCT01844700|BG002|Baseline|Total|Total of all reporting groups
11144978|NCT01844700|FG000|Participant Flow|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants"
11144979|NCT01844700|FG001|Participant Flow|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants"
11144980|NCT01844700|OG000|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
11144981|NCT01844700|OG001|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
11144982|NCT01844700|EG000|Reported Event|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes~there were no serious adverse events in this group"
11144983|NCT01844700|EG001|Reported Event|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes~there were no serious adverse events in this group"
11144984|NCT01844765|BG000|Baseline|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
11144985|NCT01844765|BG001|Baseline|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis
11144986|NCT01844765|BG002|Baseline|Total|Total of all reporting groups
11144987|NCT01844765|FG000|Participant Flow|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
11144988|NCT01844765|FG001|Participant Flow|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis
11144989|NCT01844765|OG000|Outcome|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
11144990|NCT01844765|OG000|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
11144991|NCT01844765|OG001|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
11144992|NCT01844765|OG001|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis
11144993|NCT01844765|OG000|Outcome|All Patients|All patients enrolled in the study
11144994|NCT01844765|OG000|Outcome|Resistant/i Ntolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
11144995|NCT01844765|EG000|Reported Event|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
11144996|NCT01844765|EG001|Reported Event|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis
11144997|NCT01844765|EG002|Reported Event|All Patients|All of the patients enrolled in the study.
11144998|NCT01844778|BG000|Baseline|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11144999|NCT01844778|BG001|Baseline|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145000|NCT01844778|BG002|Baseline|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145001|NCT01844778|BG003|Baseline|Total|Total of all reporting groups
11145002|NCT01844778|FG000|Participant Flow|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145003|NCT01844778|FG001|Participant Flow|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145004|NCT01844778|FG002|Participant Flow|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145005|NCT01844778|OG000|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145006|NCT01844778|OG001|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145007|NCT01844778|OG002|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145008|NCT01844778|EG000|Reported Event|TIS/TIP - Cycle 1|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment.
11145009|NCT01844778|EG001|Reported Event|TIS/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145010|NCT01844778|EG002|Reported Event|COLI/TIP - Cycle 1|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines.
11145011|NCT01844778|EG003|Reported Event|COLI/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145012|NCT01844778|EG004|Reported Event|TIP/TIP - Cycle 1|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145013|NCT01844778|EG005|Reported Event|TIP/TIP - Cycle 2|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145014|NCT01844778|EG006|Reported Event|Overall TIP Cycle 2|During the second cycle, each treatment group received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
11145015|NCT01844817|BG000|Baseline|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
11145016|NCT01844817|BG001|Baseline|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
11145017|NCT01844817|BG002|Baseline|Total|Total of all reporting groups
11145018|NCT01844817|FG000|Participant Flow|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
11145019|NCT01844817|FG001|Participant Flow|Placebo|"Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
11145020|NCT01844817|OG000|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
10879775|NCT00459732|EG001|Reported Event|Placebo|daily capsule similar in size/color to zn was taken daily by this group
11145021|NCT01844817|OG001|Outcome|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
11224701|NCT02362425|EG002|Reported Event|RYR1-RM Volunteers :Placebo|Placebo 900 mg tablets for 6 months; identical but did not contain NAC
11145022|NCT01844817|OG001|Outcome|Placebo|"Placebo (Dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
11145023|NCT01844817|EG000|Reported Event|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
11145024|NCT01844817|EG001|Reported Event|Placebo|"Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
11145025|NCT01844830|BG000|Baseline|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
11145026|NCT01844830|BG001|Baseline|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
11145027|NCT01844830|BG002|Baseline|Total|Total of all reporting groups
11145028|NCT01844830|FG000|Participant Flow|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
11145029|NCT01844830|FG001|Participant Flow|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
11145030|NCT01844830|OG000|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
11145031|NCT01844830|OG001|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
11145032|NCT01844830|EG000|Reported Event|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
11145033|NCT01844830|EG001|Reported Event|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
11145034|NCT01844895|BG000|Baseline|125 mg Abatacept (Autoinjector and Prefilled Syringe)|Participants self administered 125 mg SC abatacept weekly via prefilled syringe from Day 1 up to Day 29. Starting on Day 29, 125 mg SC abatacept was self administered weekly via autoinjector for 3 months.
11145035|NCT01844895|FG000|Participant Flow|125 mg Abatacept (Autoinjector and Prefilled Syringe)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months. Participants could discontinue from the autoinjector substudy and switch back to prefilled syringes at any time during the study. Following the 4 months of the substudy, participants could continue to receive abatacept SC via the autoinjector or switch back to the prefilled syringe until the close of the IM101-174 parent study.
11145036|NCT01844895|OG000|Outcome|125 mg Abatacept SC Using Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
11145037|NCT01844895|OG001|Outcome|125 mg Abatacept SC Using Autoinjector - Day 113|125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
11145038|NCT01844895|OG000|Outcome|125 mg Abatacept SC Prefilled Syringe - Days 22, 24, 25, 26,29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
11145039|NCT01844895|OG001|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
11145040|NCT01844895|OG000|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
11145041|NCT01844895|OG000|Outcome|125 mg Abatacept SC Using Prefilled Syringe|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
11145042|NCT01844895|OG001|Outcome|125 mg Abatacept SC Using Autoinjector|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
11145043|NCT01844895|OG000|Outcome|125 mg Abatacept SC Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
11145044|NCT01844895|OG001|Outcome|125 mg Abatacept SC Autoinjector- Day 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
11145045|NCT01844895|EG000|Reported Event|Abatacept Via Autoinjector Only (Day 29 to End of Study)|Participants received 125 mg SC abatacept via the autoinjector starting Day 29 and through the remaining 3 months of the substudy.
11145046|NCT01844895|EG001|Reported Event|Abatacept Cumulative (Prefilled Syringe and Autoinjector)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months.
11145047|NCT01845025|BG000|Baseline|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
11145048|NCT01845025|BG001|Baseline|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
11145049|NCT01845025|BG002|Baseline|Total|Total of all reporting groups
11145050|NCT01845025|FG000|Participant Flow|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
11145051|NCT01845025|FG001|Participant Flow|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
11145052|NCT01845025|OG000|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
11145053|NCT01845025|OG001|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
11145054|NCT01845025|EG000|Reported Event|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
11145055|NCT01845025|EG001|Reported Event|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
11145056|NCT01845077|BG000|Baseline|Total 1000 Fasted|Patients were administered 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11145057|NCT01845077|BG001|Baseline|Total 1000 Fed|Patients were administered 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR orally in the morning under fed conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fed conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11145058|NCT01845077|BG002|Baseline|Total 1500 Fasted|Patients were administered 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11145059|NCT01845077|BG003|Baseline|Total|Total of all reporting groups
11145060|NCT01845077|FG000|Participant Flow|FDC1000 Fasted, Then L+M1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11145061|NCT01845077|FG001|Participant Flow|L+M1000 Fasted, Then FDC1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11145062|NCT01845077|FG002|Participant Flow|FDC1000 Fed, Then L+M1000 Fed|1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11145063|NCT01845077|FG003|Participant Flow|L+M1000 Fed, Then FDC1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11145064|NCT01845077|FG004|Participant Flow|FDC1500 Fasted, Then L+M1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11145065|NCT01845077|FG005|Participant Flow|L+M1500 Fasted, Then FDC1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
11224702|NCT02362425|EG003|Reported Event|Healthy Volunteers|Healthy volunteers were evaluated at a one-visit assessment at baseline to determine normal values of biomarkers, muscle ultrasound, and near infrared spectroscopy in order to develop a comparison between healthy and RYR1-RM individuals
11224703|NCT02362594|BG000|Baseline|Pembrolizumab|In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
11224704|NCT02362594|BG001|Baseline|Placebo|In Part 1, participants received placebo IV as post-surgery therapy Q3W.
11224705|NCT02362594|BG002|Baseline|Total|Total of all reporting groups
11224706|NCT02362594|FG000|Participant Flow|Pembrolizumab|In Part 1, participants received pembrolizumab 200 mg intravenously (IV) as post-surgery therapy every 3 weeks (Q3W) for up to 1 year.
11224707|NCT02362594|FG001|Participant Flow|Placebo|In Part 1, participants received placebo IV as post-surgery therapy Q3W.
11224708|NCT02362594|OG000|Outcome|Pembrolizumab|In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
11224709|NCT02362594|OG001|Outcome|Placebo|In Part 1, participants received placebo IV as post-surgery therapy Q3W.
10879776|NCT00459810|BG000|Baseline|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
11224710|NCT02362594|EG000|Reported Event|Pembrolizumab|In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
11224711|NCT02362594|EG001|Reported Event|Placebo|In Part 1, participants received placebo IV as post-surgery therapy Q3W.
11224712|NCT02362646|BG000|Baseline|MPC Intramyocardial Injection|MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells (MPCs) at the time of LVAD implantation
11224713|NCT02362646|BG001|Baseline|Control Solution|Control Solution: Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
11224714|NCT02362646|BG002|Baseline|Total|Total of all reporting groups
11224715|NCT02362646|FG000|Participant Flow|MPC Intramyocardial Injection|MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells (MPCs) at the time of LVAD implantation
11224716|NCT02362646|FG001|Participant Flow|Control Solution|Control Solution: Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
11224717|NCT02362646|OG000|Outcome|MPC Intramyocardial Injection|MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells (MPCs) at the time of LVAD implantation
11224718|NCT02362646|OG001|Outcome|Control Solution|Control Solution: Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
11224719|NCT02362646|OG000|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 150 million MPCs~MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation"
11224720|NCT02362646|OG001|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~Control Solution"
11224721|NCT02362646|EG000|Reported Event|MPC Intramyocardial Injection|"Intramyocardial injections of 150 million MPCs~MPC Intramyocardial Injection: Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation"
11224722|NCT02362646|EG001|Reported Event|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~Control Solution"
11224723|NCT02362672|BG000|Baseline|NKTR-181|NKTR-181 (Double-blind Treatment Phase)
11224724|NCT02362672|BG001|Baseline|Placebo|Placebo (Double-blind Treatment Phase)
11224725|NCT02362672|BG002|Baseline|Total|Total of all reporting groups
11224726|NCT02362672|FG000|Participant Flow|NKTR-181 (Open-label Titration Phase)|NKTR-181 100-400 mg twice daily tablets
11224727|NCT02362672|FG001|Participant Flow|NKTR-181 (Double-blind Treatment Phase)|NKTR-181: 100-400 mg twice daily tablets
11224728|NCT02362672|FG002|Participant Flow|Placebo (Double-blind Treatment Phase)|Placebo: Placebo, twice daily tablets
11224729|NCT02362672|OG000|Outcome|NKTR-181|NKTR-181 (Double-blind Treatment Phase)
11224730|NCT02362672|OG001|Outcome|Placebo|Placebo (Double-blind Treatment Phase)
11224731|NCT02362672|OG000|Outcome|NKTR-181|NKTR-181 (Double-blind treatment phase)
11224732|NCT02362672|OG001|Outcome|Placebo|Placebo (Double-blind treatment phase)
11224733|NCT02362672|EG000|Reported Event|NKTR-181 (Titration Phase)|NKTR-181 100-400 mg twice daily tablets
11224734|NCT02362672|EG001|Reported Event|NKTR-181 (Double-blind Treatment Phase)|NKTR-181 100-400 mg twice daily tablets
11224735|NCT02362672|EG002|Reported Event|Placebo (Double-blind Treatment Phase)|Placebo, twice daily tablets
11224736|NCT02362724|BG000|Baseline|Sapphire|"Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration~Sapphire: silicone hydrogel contact lens"
11224737|NCT02362724|BG001|Baseline|Pearl|"Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration~Pearl: silicone hydrogel contact lens"
11224738|NCT02362724|BG002|Baseline|Total|Total of all reporting groups
11224739|NCT02362724|FG000|Participant Flow|Sapphire|"Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration~Sapphire: silicone hydrogel contact lens"
11224740|NCT02362724|FG001|Participant Flow|Pearl|"Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration~Pearl: silicone hydrogel contact lens"
11224741|NCT02362724|OG000|Outcome|Sapphire|"Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration~Sapphire: silicone hydrogel contact lens"
11224742|NCT02362724|OG001|Outcome|Pearl|"Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration~Pearl: silicone hydrogel contact lens"
11224743|NCT02362724|EG000|Reported Event|Sapphire|"Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration~Sapphire: silicone hydrogel contact lens"
11224744|NCT02362724|EG001|Reported Event|Pearl|"Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration~Pearl: silicone hydrogel contact lens"
11145066|NCT01845077|OG000|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
11145067|NCT01845077|OG001|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
11145068|NCT01845077|OG002|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
11145069|NCT01845077|OG003|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
11145070|NCT01845077|OG004|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
11145071|NCT01845077|OG005|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
11145072|NCT01845077|OG005|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
11145073|NCT01845077|EG000|Reported Event|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
11145074|NCT01845077|EG001|Reported Event|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
11145075|NCT01845077|EG002|Reported Event|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
11145076|NCT01845077|EG003|Reported Event|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
11145077|NCT01845077|EG004|Reported Event|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
11145078|NCT01845077|EG005|Reported Event|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
11145079|NCT01845103|BG000|Baseline|PEARL 8.0|
11145080|NCT01845103|FG000|Participant Flow|PEARL 8.0|Received TMR with PEARL 8.0
11145081|NCT01845103|OG000|Outcome|PEARL 8.0|
11145082|NCT01845103|EG000|Reported Event|PEARL 8.0|
11145083|NCT01845155|BG000|Baseline|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
11145084|NCT01845155|BG001|Baseline|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
11145085|NCT01845155|BG002|Baseline|Total|Total of all reporting groups
11145086|NCT01845155|FG000|Participant Flow|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
11145087|NCT01845155|FG001|Participant Flow|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
11145088|NCT01845155|OG000|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
11145089|NCT01845155|OG001|Outcome|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
11145090|NCT01845155|EG000|Reported Event|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
11224745|NCT02362789|BG000|Baseline|Secukinumab|300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28
11224746|NCT02362789|BG001|Baseline|Placebo|Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
10879777|NCT00459810|FG000|Participant Flow|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
11145091|NCT01845155|EG001|Reported Event|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
11145092|NCT01845220|BG000|Baseline|All Participants|"Total number of subjects is 30. Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Thus, 60 skin areas will be randomized.~Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge Placebo Comparator."
11145093|NCT01845220|FG000|Participant Flow|Broccoli Sprout Extract|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge"
11145094|NCT01845220|FG001|Participant Flow|Placebo|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Placebo: 80% acetone"
11145095|NCT01845220|OG000|Outcome|Broccoli Sprout Extract|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge"
11145096|NCT01845220|OG001|Outcome|Placebo|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Placebo: 80% acetone"
11145097|NCT01845220|EG000|Reported Event|Broccoli Sprout Extract|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge"
11145098|NCT01845220|EG001|Reported Event|Placebo|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Placebo: 80% acetone"
11145099|NCT01845636|BG000|Baseline|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
11145100|NCT01845636|FG000|Participant Flow|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
11145101|NCT01845636|OG000|Outcome|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
11145102|NCT01845636|EG000|Reported Event|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
11145103|NCT01845792|BG000|Baseline|Cabazitaxel With Abiraterone Acetate|"Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.~Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily."
11145104|NCT01845792|BG001|Baseline|Cabazitaxel Alone|"Cabazitaxel administered as a single intravenous dose every 3 weeks~Cabazitaxel: Cabazitaxel intravenously every 3 weeks"
11145105|NCT01845792|BG002|Baseline|Total|Total of all reporting groups
11145106|NCT01845792|FG000|Participant Flow|Cabazitaxel With Abiraterone Acetate|"Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.~Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily."
11145107|NCT01845792|FG001|Participant Flow|Cabazitaxel Alone|"Cabazitaxel administered as a single intravenous dose every 3 weeks~Cabazitaxel: Cabazitaxel intravenously every 3 weeks"
11224747|NCT02362789|BG002|Baseline|Total|Total of all reporting groups
11145108|NCT01845792|OG000|Outcome|Cabazitaxel With Abiraterone Acetate|"Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.~Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily."
11145109|NCT01845792|OG001|Outcome|Cabazitaxel Alone|"Cabazitaxel administered as a single intravenous dose every 3 weeks~Cabazitaxel: Cabazitaxel intravenously every 3 weeks"
11145110|NCT01845792|EG000|Reported Event|Cabazitaxel With Abiraterone Acetate|"Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.~Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily."
11145111|NCT01845792|EG001|Reported Event|Cabazitaxel Alone|"Cabazitaxel administered as a single intravenous dose every 3 weeks~Cabazitaxel: Cabazitaxel intravenously every 3 weeks"
11145112|NCT01845818|BG000|Baseline|Ankylosing Spondylitis|Participants with ankylosing spondylitis and in whom adalimumab treatment was initiated.
11145113|NCT01845818|BG001|Baseline|Psoriatic Arthritis|Participants with psoriatic arthritis and in whom adalimumab treatment was initiated.
11145114|NCT01845818|BG002|Baseline|Total|Total of all reporting groups
11145115|NCT01845818|FG000|Participant Flow|Ankylosing Spondylitis|Participants with ankylosing spondylitis and in whom adalimumab treatment is initiated.
11145116|NCT01845818|FG001|Participant Flow|Psoriatic Arthritis|Participants with psoriatic arthritis and in whom adalimumab treatment is initiated.
11145117|NCT01845818|OG000|Outcome|Ankylosing Spondylitis and Psoriatic Arthritis|Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
11145118|NCT01845818|OG000|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.
11145119|NCT01845818|OG001|Outcome|Psoriatic Arthritis|Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
11145120|NCT01845818|OG002|Outcome|Ankylosing Spondylitis and Psoriatic Arthritis|Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
11145121|NCT01845818|OG000|Outcome|Psoriatic Arthritis|Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
11145122|NCT01845818|EG000|Reported Event|Ankylosing Spondylitis and Psoriatic Arthritis|Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
11145123|NCT01845831|BG000|Baseline|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
11145124|NCT01845831|BG001|Baseline|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
11145125|NCT01845831|BG002|Baseline|Total|Total of all reporting groups
11145126|NCT01845831|FG000|Participant Flow|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
11145127|NCT01845831|FG001|Participant Flow|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
11145128|NCT01845831|FG002|Participant Flow|Metformin and Sitagliptin|"Outpatient Phase:~Patients with HbA1c ≤ 7% during the inpatient phase were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months~Metformin and sitagliptin: Patients with HbA1c ≤ 7% were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months"
11145129|NCT01845831|FG003|Participant Flow|Metformin and Sitagliptin + Glargine 50%|"Outpatient Phase:~Patients with HbA1c between 7% and 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 50%: Patients with HbA1c between 7% and 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months"
11145130|NCT01845831|FG004|Participant Flow|Metformin and Sitagliptin + Glargine 80%|"Outpatient Phase:~Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months"
11145131|NCT01845831|OG000|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
11145132|NCT01845831|OG001|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
11145133|NCT01845831|OG000|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
11145134|NCT01845831|OG001|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
11145135|NCT01845831|OG000|Outcome|Metformin and Sitagliptin|"Outpatient Phase:~Patients with HbA1c < 7% during the inpatient phase were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months~Metformin and sitagliptin: Patients with HbA1c ≤ 7% were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months"
11224748|NCT02362789|FG000|Participant Flow|Run-in|300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 0, 1, 2, 3, 4, 8, and 12
11224749|NCT02362789|FG001|Participant Flow|Secukinumab|300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28
11224750|NCT02362789|FG002|Participant Flow|Placebo|Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
11224751|NCT02362789|OG000|Outcome|Secukinumab|300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28
11224752|NCT02362789|OG001|Outcome|Placebo|Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
11224753|NCT02362789|EG000|Reported Event|Run-In|300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 0, 1, 2, 3, 4, 8, and 12
11224754|NCT02362789|EG001|Reported Event|Secukinumab|300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28
11224755|NCT02362789|EG002|Reported Event|Placebo|Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
11224756|NCT02363270|BG000|Baseline|IV Push Group|"Ketamine medication given via IV Push. IV Push is the intervention.~Ketamine: IV Push or or IV Drip"
11224757|NCT02363270|BG001|Baseline|IV Drip Group|"Ketamine medication given via IV Drip. IV Drip is the intervention.~Ketamine: IV Push or or IV Drip"
10879778|NCT00459810|OG000|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
11224758|NCT02363270|BG002|Baseline|Total|Total of all reporting groups
11224759|NCT02363270|FG000|Participant Flow|IV Push Group|"Ketamine medication given via IV Push. IV Push is the intervention.~Ketamine: IV Push or or IV Drip"
11224760|NCT02363270|FG001|Participant Flow|IV Drip Group|"Ketamine medication given via IV Drip. IV Drip is the intervention.~Ketamine: IV Push or or IV Drip"
11224761|NCT02363270|OG000|Outcome|IV Push Group|"Ketamine medication given via IV Push. IV Push is the intervention.~Ketamine: IV Push or or IV Drip"
11224762|NCT02363270|OG001|Outcome|IV Drip Group|"Ketamine medication given via IV Drip. IV Drip is the intervention.~Ketamine: IV Push or or IV Drip"
11224763|NCT02363270|EG000|Reported Event|IV Push Group|"Ketamine medication given via IV Push. IV Push is the intervention.~Ketamine: IV Push or or IV Drip"
11224764|NCT02363270|EG001|Reported Event|IV Drip Group|"Ketamine medication given via IV Drip. IV Drip is the intervention.~Ketamine: IV Push or or IV Drip"
11224765|NCT02363283|BG000|Baseline|Treatment (Glembatumumab Vedotin)|"Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.~Glembatumumab Vedotin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11224766|NCT02363283|FG000|Participant Flow|Treatment (Glembatumumab Vedotin)|"Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.~Glembatumumab Vedotin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11224767|NCT02363283|OG000|Outcome|Treatment (Glembatumumab Vedotin)|"Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.~Glembatumumab Vedotin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11224768|NCT02363283|EG000|Reported Event|Treatment (Glembatumumab Vedotin)|"Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.~Glembatumumab Vedotin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11224769|NCT02363322|BG000|Baseline|A/Current Standard of Care Alone|Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting
11224770|NCT02363322|BG001|Baseline|B/Current Standard of Care Plus ZMapp|"ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.~ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus"
11224771|NCT02363322|BG002|Baseline|Total|Total of all reporting groups
11224772|NCT02363322|FG000|Participant Flow|A/Current Standard of Care Alone|"Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting~Treatment A: Optimized standard of care for Ebola virus infection"
11224773|NCT02363322|FG001|Participant Flow|B/Current Standard of Care Plus ZMapp|"ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.~ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus"
11224774|NCT02363322|OG000|Outcome|A/Current Standard of Care Alone|Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting
11224775|NCT02363322|OG001|Outcome|B/Current Standard of Care Plus ZMapp|"ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.~ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus"
11224776|NCT02363322|EG000|Reported Event|A/Current Standard of Care Alone|Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting
11224777|NCT02363322|EG001|Reported Event|B/Current Standard of Care Plus ZMapp|"ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.~ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus"
11224778|NCT02363439|BG000|Baseline|IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk|Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 twice weekly per Protocol 8400-401
11224779|NCT02363439|FG000|Participant Flow|IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk|Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
11224780|NCT02363439|OG000|Outcome|IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk|Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
11224781|NCT02363439|EG000|Reported Event|IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk|Subcutaneous injection of IMO-8400 0.6mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
11224782|NCT02363478|BG000|Baseline|Buspirone|22 out of 30 participants (19 female) completed the study.
11224783|NCT02363478|FG000|Participant Flow|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
11224784|NCT02363478|OG000|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
11224785|NCT02363478|OG000|Outcome|Buspirone|"4-weeks buspirone administration (20mg) in patients with SSc and esophageal involvement~buspirone: buspirone 10 mg X2 for 4 weeks"
11224786|NCT02363478|EG000|Reported Event|Buspirone|Participants received bouspirone 20 mg/day for 4 weeks
11224787|NCT02363621|BG000|Baseline|Ranibizumab 0.3 Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.3 mg once~Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg"
11224788|NCT02363621|BG001|Baseline|Aflibercept 2.0 mg Intravitreal Injection|"Intravitreal Aflibercept 2.0 mg once~Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg"
11224789|NCT02363621|BG002|Baseline|Total|Total of all reporting groups
11224790|NCT02363621|FG000|Participant Flow|Ranibizumab 0.3 Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.3 mg once~Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg"
11224791|NCT02363621|FG001|Participant Flow|Aflibercept 2.0 mg Intravitreal Injection|"Intravitreal Aflibercept 2.0 mg once~Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg"
11224792|NCT02363621|OG000|Outcome|Ranibizumab 0.3 Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.3 mg once~Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg"
11224793|NCT02363621|OG001|Outcome|Aflibercept 2.0 mg Intravitreal Injection|"Intravitreal Aflibercept 2.0 mg once~Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg"
11224794|NCT02363621|EG000|Reported Event|Ranibizumab 0.3 Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.3 mg once~Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg"
11224795|NCT02363621|EG001|Reported Event|Aflibercept 2.0 mg Intravitreal Injection|"Intravitreal Aflibercept 2.0 mg once~Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg"
11224796|NCT02363686|BG000|Baseline|FEES & Bedside Swallow Evaluation (BSE)|"Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).~FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.~BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test."
11224797|NCT02363686|FG000|Participant Flow|FEES & Bedside Swallow Evaluation (BSE)|"Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).~FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.~BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test."
11224798|NCT02363686|OG000|Outcome|FEES & Bedside Swallow Evaluation (BSE)|"A speech language pathologist (SLP) will perform a bedside swallowing evaluation (BSE).followed by a Fiberoptic Endoscopic Evaluation of Swallowing (FEES). BSE: Before the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with five food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.~."
11226862|NCT02378714|BG001|Baseline|BASC + Placebo Varenicline|"Behavioral activation for smoking cessation plus placebo varenicline~BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.~Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11224799|NCT02363686|EG000|Reported Event|FEES & Bedside Swallow Evaluation (BSE)|"Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).~FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.~BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test."
11224800|NCT02363738|BG000|Baseline|Infliximab|"Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation~Infliximab: Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation. Infliximab will be prescribed adjunctively to a conventional mood stabilizer or atypical antipsychotic agent."
11224801|NCT02363738|BG001|Baseline|Saline (Placebo)|"Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency.~Saline: Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency and will be administered adjunctively to conventional mood stabilizer or atypical antipsychotic agent."
11224802|NCT02363738|BG002|Baseline|Total|Total of all reporting groups
11224803|NCT02363738|FG000|Participant Flow|Infliximab|"Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation~Infliximab: Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation. Infliximab will be prescribed adjunctively to a conventional mood stabilizer or atypical antipsychotic agent."
11224804|NCT02363738|FG001|Participant Flow|Saline (Placebo)|"Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency.~Saline: Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency and will be administered adjunctively to conventional mood stabilizer or atypical antipsychotic agent."
11224805|NCT02363738|OG000|Outcome|Infliximab|"Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation~Infliximab: Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation. Infliximab will be prescribed adjunctively to a conventional mood stabilizer or atypical antipsychotic agent."
11224806|NCT02363738|OG001|Outcome|Saline (Placebo)|"Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency.~Saline: Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency and will be administered adjunctively to conventional mood stabilizer or atypical antipsychotic agent."
10879779|NCT00459810|EG000|Reported Event|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
11224807|NCT02363738|EG000|Reported Event|Infliximab|"Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation~Infliximab: Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation. Infliximab will be prescribed adjunctively to a conventional mood stabilizer or atypical antipsychotic agent."
11224808|NCT02363738|EG001|Reported Event|Saline (Placebo)|"Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency.~Saline: Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency and will be administered adjunctively to conventional mood stabilizer or atypical antipsychotic agent."
11224809|NCT02363803|BG000|Baseline|Saline First, Then Lidocaine|Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 1). Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 2)
11224810|NCT02363803|BG001|Baseline|Lidocaine First, Then Saline|Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 1). Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 2).
11224811|NCT02363803|BG002|Baseline|Total|Total of all reporting groups
11224812|NCT02363803|FG000|Participant Flow|Saline First, Then Lidocaine|Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 1). Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 2)
11224813|NCT02363803|FG001|Participant Flow|Lidocaine First, Then Saline|Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 1). Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 2).
11224814|NCT02363803|OG000|Outcome|Normal Saline Infusion|"Intravenous infusion of normal saline over a 40 minute period.~Placebo: Normal saline, approved for hypovolemia, and homeostasis."
11224815|NCT02363803|OG001|Outcome|Lidocaine Infusion|"Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period.~lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias."
11224816|NCT02363803|OG000|Outcome|Normal Saline: Prior to Infusion|Intravenous infusion of normal saline over a 40 minute period.
11224817|NCT02363803|OG001|Outcome|Normal Saline: 60 Minutes After Infusion Initiation|Intravenous infusion of normal saline over a 40 minute period.
11224818|NCT02363803|OG002|Outcome|Lidocaine: Prior to Infusion|Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period.
11224819|NCT02363803|OG003|Outcome|Lidocaine: 60 Minutes After Infusion Initiation|Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period.
11224820|NCT02363803|OG000|Outcome|Normal Saline Infusion|Intravenous infusion of normal saline over a 40 minute period.
11224821|NCT02363803|OG001|Outcome|Lidocaine Infusion|Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period.
11224822|NCT02363803|EG000|Reported Event|Normal Saline Infusion|"Intravenous infusion of normal saline over a 40 minute period.~Placebo: Normal saline, approved for hypovolemia, and homeostasis."
11224823|NCT02363803|EG001|Reported Event|Lidocaine Infusion|"Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period.~lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias."
11224824|NCT02363907|BG000|Baseline|Single Arm|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
11224825|NCT02363907|FG000|Participant Flow|Single Arm- Performance, Using Blood Glucose Meter Reference|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
11224826|NCT02363907|OG000|Outcome|Single Arm|Subjects as their own control, comparing ISF glucose readings to capillary blood glucose readings, measured by blood glucose meters
11224827|NCT02363907|EG000|Reported Event|Single Arm,Performance, Using Blood Glucose Meter Reference|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
11224828|NCT02363933|BG000|Baseline|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
11224829|NCT02363933|FG000|Participant Flow|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
11224830|NCT02363933|OG000|Outcome|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
11224831|NCT02363933|EG000|Reported Event|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
11224832|NCT02363946|BG000|Baseline|Part A: 0.38 mg/kg|Single dose administration of ARC-AAT IV injection, 0.38 mg/kg in healthy volunteers
11224833|NCT02363946|BG001|Baseline|Part A: 1.0 mg/kg|Single dose administration of ARC-AAT IV injection, 1.0 mg/kg in healthy volunteers
11224834|NCT02363946|BG002|Baseline|Part A: 2.0 mg/kg|Single dose administration of ARC-AAT IV injection, 2.0 mg/kg in healthy volunteers
11224835|NCT02363946|BG003|Baseline|Part A: 3.0 mg/kg|Single dose administration of ARC-AAT IV injection, 3.0 mg/kg in healthy volunteers
11224836|NCT02363946|BG004|Baseline|Part A: 4.0 mg/kg|Single dose administration of ARC-AAT IV injection, 4.0 mg/kg in healthy volunteers
11224837|NCT02363946|BG005|Baseline|Part A: 5.0 mg/kg|Single dose administration of ARC-AAT IV injection, 5.0 mg/kg in healthy volunteers
11224838|NCT02363946|BG006|Baseline|Part A: 6.0 mg/kg|Single dose administration of ARC-AAT IV injection, 6.0 mg/kg in healthy volunteers
11224839|NCT02363946|BG007|Baseline|Part A: 7.0 mg/kg|Single dose administration of ARC-AAT IV injection, 7.0 mg/kg in healthy volunteers
11224840|NCT02363946|BG008|Baseline|Part A: 8.0 mg/kg|Single dose administration of ARC-AAT IV injection, 8.0 mg/kg in healthy volunteers
11224841|NCT02363946|BG009|Baseline|Part A: Placebo|Single dose administration of 0.9% normal saline IV injection in healthy volunteers
11224842|NCT02363946|BG010|Baseline|Part B: 2.0 mg/kg|Single dose administration of ARC-AAT IV injection, 2.0 mg/kg in participants with alpha-1 antitrypsin deficiency (AATD)
11224843|NCT02363946|BG011|Baseline|Part B: 4.0 mg/kg|Single dose administration of ARC-AAT IV injection, 4.0 mg/kg in participants with AATD
11224844|NCT02363946|BG012|Baseline|Part B: Placebo|Single dose administration of 0.9% normal saline IV injection in participants with AATD
11224845|NCT02363946|BG013|Baseline|Total|Total of all reporting groups
11224846|NCT02363946|FG000|Participant Flow|Part A: 0.38 mg/kg|Single dose administration of ARC-AAT intravenous (IV) injection, 0.38 mg/kg in healthy volunteers
11224847|NCT02363946|FG001|Participant Flow|Part A: 1.0 mg/kg|Single dose administration of ARC-AAT IV injection, 1.0 mg/kg in healthy volunteers
11224848|NCT02363946|FG002|Participant Flow|Part A: 2.0 mg/kg|Single dose administration of ARC-AAT IV injection, 2.0 mg/kg in healthy volunteers
11224849|NCT02363946|FG003|Participant Flow|Part A: 3.0 mg/kg|Single dose administration of ARC-AAT IV injection, 3.0 mg/kg in healthy volunteers
11224850|NCT02363946|FG004|Participant Flow|Part A: 4.0 mg/kg|Single dose administration of ARC-AAT IV injection, 4.0 mg/kg in healthy volunteers
11224851|NCT02363946|FG005|Participant Flow|Part A: 5.0 mg/kg|Single dose administration of ARC-AAT IV injection, 5.0 mg/kg in healthy volunteers
11224852|NCT02363946|FG006|Participant Flow|Part A: 6.0 mg/kg|Single dose administration of ARC-AAT IV injection, 6.0 mg/kg in healthy volunteers
11224853|NCT02363946|FG007|Participant Flow|Part A: 7.0 mg/kg|Single dose administration of ARC-AAT IV injection, 7.0 mg/kg in healthy volunteers
11224854|NCT02363946|FG008|Participant Flow|Part A: 8.0 mg/kg|Single dose administration of ARC-AAT IV injection, 8.0 mg/kg in healthy volunteers
11224855|NCT02363946|FG009|Participant Flow|Part A: Placebo|Single dose administration of 0.9% normal saline IV injection in healthy volunteers
11224856|NCT02363946|FG010|Participant Flow|Part B: 2.0 mg/kg|Single dose administration of ARC-AAT IV injection, 2.0 mg/kg in participants with alpha-1 antitrypsin deficiency (AATD)
11224857|NCT02363946|FG011|Participant Flow|Part B: 4.0 mg/kg|Single dose administration of ARC-AAT IV injection, 4.0 mg/kg in participants with AATD
11224858|NCT02363946|FG012|Participant Flow|Part B: Placebo|Single dose administration of 0.9% normal saline IV injection in participants with AATD
11224859|NCT02363946|OG000|Outcome|Part A: 0.38 mg/kg|Single dose administration of ARC-AAT IV injection, 0.38 mg/kg in healthy volunteers
11224860|NCT02363946|OG001|Outcome|Part A: 1.0 mg/kg|Single dose administration of ARC-AAT IV injection, 1.0 mg/kg in healthy volunteers
11224861|NCT02363946|OG002|Outcome|Part A: 2.0 mg/kg|Single dose administration of ARC-AAT IV injection, 2.0 mg/kg in healthy volunteers
11224862|NCT02363946|OG003|Outcome|Part A: 3.0 mg/kg|Single dose administration of ARC-AAT IV injection, 3.0 mg/kg in healthy volunteers
11224863|NCT02363946|OG004|Outcome|Part A: 4.0 mg/kg|Single dose administration of ARC-AAT IV injection, 4.0 mg/kg in healthy volunteers
11224864|NCT02363946|OG005|Outcome|Part A: 5.0 mg/kg|Single dose administration of ARC-AAT IV injection, 5.0 mg/kg in healthy volunteers
11224865|NCT02363946|OG006|Outcome|Part A: 6.0 mg/kg|Single dose administration of ARC-AAT IV injection, 6.0 mg/kg in healthy volunteers
11224866|NCT02363946|OG007|Outcome|Part A: 7.0 mg/kg|Single dose administration of ARC-AAT IV injection, 7.0 mg/kg in healthy volunteers
11224867|NCT02363946|OG008|Outcome|Part A: 8.0 mg/kg|Single dose administration of ARC-AAT IV injection, 8.0 mg/kg in healthy volunteers
11224868|NCT02363946|OG009|Outcome|Part A: Placebo|Single dose administration of 0.9% normal saline IV injection in healthy volunteers
11224869|NCT02363946|OG010|Outcome|Part B: 2.0 mg/kg|Single dose administration of ARC-AAT IV injection, 2.0 mg/kg in participants with AATD
11224870|NCT02363946|OG011|Outcome|Part B: 4.0 mg/kg|Single dose administration of ARC-AAT IV injection, 4.0 mg/kg in participants with AATD
11224871|NCT02363946|OG012|Outcome|Part B: Placebo|Single dose administration of 0.9% normal saline IV injection in participants with AATD
11224872|NCT02363946|EG000|Reported Event|Part A: 0.38 mg/kg|Single dose administration of ARC-AAT IV injection, 0.38 mg/kg in healthy volunteers
11224873|NCT02363946|EG001|Reported Event|Part A: 1.0 mg/kg|Single dose administration of ARC-AAT IV injection, 1.0 mg/kg in healthy volunteers
11224874|NCT02363946|EG002|Reported Event|Part A: 2.0 mg/kg|Single dose administration of ARC-AAT IV injection, 2.0 mg/kg in healthy volunteers
11224875|NCT02363946|EG003|Reported Event|Part A: 3.0 mg/kg|Single dose administration of ARC-AAT IV injection, 3.0 mg/kg in healthy volunteers
11224876|NCT02363946|EG004|Reported Event|Part A: 4.0 mg/kg|Single dose administration of ARC-AAT IV injection, 4.0 mg/kg in healthy volunteers
11224877|NCT02363946|EG005|Reported Event|Part A: 5.0 mg/kg|Single dose administration of ARC-AAT IV injection, 5.0 mg/kg in healthy volunteers
11224878|NCT02363946|EG006|Reported Event|Part A: 6.0 mg/kg|Single dose administration of ARC-AAT IV injection, 6.0 mg/kg in healthy volunteers
10879780|NCT00459862|BG000|Baseline|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
11224879|NCT02363946|EG007|Reported Event|Part A: 7.0 mg/kg|Single dose administration of ARC-AAT IV injection, 7.0 mg/kg in healthy volunteers
11224880|NCT02363946|EG008|Reported Event|Part A: 8.0 mg/kg|Single dose administration of ARC-AAT IV injection, 8.0 mg/kg in healthy volunteers
11224881|NCT02363946|EG009|Reported Event|Part A: Placebo|Single dose administration of 0.9% normal saline IV injection in healthy volunteers
11224882|NCT02363946|EG010|Reported Event|Part B: 2.0 mg/kg|Single dose administration of ARC-AAT IV injection, 2.0 mg/kg in participants with AATD
11224883|NCT02363946|EG011|Reported Event|Part B: 4.0 mg/kg|Single dose administration of ARC-AAT IV injection, 4.0 mg/kg in participants with AATD
11224884|NCT02363946|EG012|Reported Event|Part B: Placebo|Single dose administration of 0.9% normal saline IV injection in participants with AATD
11224885|NCT02363959|BG000|Baseline|Hyperbaric Oxygen, Airway Biopsy|"The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.~During standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure."
11224886|NCT02363959|BG001|Baseline|No Hyperbaric Oxygen, Airway Biopsy|"No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.~Endobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung."
11224887|NCT02363959|BG002|Baseline|Total|Total of all reporting groups
11224888|NCT02363959|FG000|Participant Flow|Hyperbaric Oxygen, Airway Biopsy|"The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.~During standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure."
11342023|NCT03695094|OG000|Outcome|Group 1 (Inducers) (PK-PPS)|Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
11224889|NCT02363959|FG001|Participant Flow|No Hyperbaric Oxygen, Airway Biopsy|"No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.~Endobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung."
11145136|NCT01845831|OG001|Outcome|Metformin and Sitagliptin + Glargine 50%|"Outpatient Phase:~Patients with HbA1c between 7% and 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 50%: Patients with HbA1c between 7% and 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months"
11145137|NCT01845831|OG002|Outcome|Metformin and Sitagliptin + Glargine 80%|"Outpatient Phase:~Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months"
11145138|NCT01845831|EG000|Reported Event|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
11145139|NCT01845831|EG001|Reported Event|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
11145140|NCT01845974|BG000|Baseline|Low Flow Catheter|"The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
11145141|NCT01845974|BG001|Baseline|High Flow Catheter|"The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
11145142|NCT01845974|BG002|Baseline|Total|Total of all reporting groups
11145143|NCT01845974|FG000|Participant Flow|Low Flow Catheter|"The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
11145144|NCT01845974|FG001|Participant Flow|High Flow Catheter|"The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
11145145|NCT01845974|OG000|Outcome|Low Flow Catheter|"The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
11145146|NCT01845974|OG001|Outcome|High Flow Catheter|"The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
11145147|NCT01845974|EG000|Reported Event|Low Flow Catheter|"The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
11145148|NCT01845974|EG001|Reported Event|High Flow Catheter|"The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
11145149|NCT01846039|BG000|Baseline|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
11145150|NCT01846039|FG000|Participant Flow|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
11145151|NCT01846039|OG000|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
11145152|NCT01846039|EG000|Reported Event|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
11145153|NCT01846104|BG000|Baseline|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
11145154|NCT01846104|FG000|Participant Flow|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial (NCT01317667). Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
11145155|NCT01846104|OG000|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
11145156|NCT01846104|EG000|Reported Event|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
11145157|NCT01846208|BG000|Baseline|Baked Egg Randomized|"Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and safe commercial products with up to four oral food challenges as directed by the protocol.~Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions."
11145158|NCT01846208|BG001|Baseline|Egg OIT Randomized|"Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.~Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses."
11145159|NCT01846208|BG002|Baseline|Egg OIT Assigned|"Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.~Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses."
11145160|NCT01846208|BG003|Baseline|Total|Total of all reporting groups
11145161|NCT01846208|FG000|Participant Flow|Baked Egg Randomized|"Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and safe commercial products with up to four oral food challenges as directed by the protocol.~Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions."
11145162|NCT01846208|FG001|Participant Flow|Egg OIT Randomized|"Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.~Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses."
11145163|NCT01846208|FG002|Participant Flow|Egg OIT Assigned|"Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.~Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses."
10879781|NCT00459862|FG000|Participant Flow|Arm I|Patients receive 800mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
11145164|NCT01846208|OG000|Outcome|Baked Egg Randomized|"Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and safe commercial products with up to four oral food challenges as directed by the protocol.~Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions."
11145165|NCT01846208|OG001|Outcome|Egg OIT Randomized|"Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.~Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses."
11145166|NCT01846208|OG002|Outcome|Egg OIT Assigned|"Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.~Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses."
11145167|NCT01846208|EG000|Reported Event|Baked Egg Randomized|"Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and safe commercial products with up to four oral food challenges as directed by the protocol.~Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions."
11348801|NCT04147442|OG001|Outcome|Music Standard Program|"The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings.~They will perform the test with the standard default music program."
10879782|NCT00459862|OG000|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
11145168|NCT01846208|EG001|Reported Event|Egg OIT Randomized|"Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.~Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses."
11348802|NCT04147442|OG002|Outcome|Unaided|The participants will perform the test with no hearing aids.
10879783|NCT00459862|EG000|Reported Event|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
10879784|NCT00459875|BG000|Baseline|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
10879785|NCT00459875|FG000|Participant Flow|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
11145169|NCT01846208|EG002|Reported Event|Egg OIT Assigned|"Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.~Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses."
11145170|NCT01846221|BG000|Baseline|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
11145171|NCT01846221|BG001|Baseline|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
11145172|NCT01846221|BG002|Baseline|Total|Total of all reporting groups
10879786|NCT00459875|OG000|Outcome|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
10879787|NCT00459875|EG000|Reported Event|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
10879788|NCT00459953|BG000|Baseline|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
10879789|NCT00459953|BG001|Baseline|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
10879790|NCT00459953|BG002|Baseline|Total|Total of all reporting groups
11009475|NCT01102374|BG000|Baseline|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
11145173|NCT01846221|FG000|Participant Flow|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
10879791|NCT00459953|FG000|Participant Flow|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
11145174|NCT01846221|FG001|Participant Flow|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
11145175|NCT01846221|OG000|Outcome|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
11145176|NCT01846221|OG001|Outcome|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
11145177|NCT01846221|EG000|Reported Event|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
11145178|NCT01846221|EG001|Reported Event|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
11145179|NCT01846299|BG000|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
11145180|NCT01846299|BG001|Baseline|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
11145181|NCT01846299|BG002|Baseline|Total|Total of all reporting groups
11145182|NCT01846299|FG000|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
11145183|NCT01846299|FG001|Participant Flow|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
11145184|NCT01846299|OG000|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
11145185|NCT01846299|OG001|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
11145186|NCT01846299|OG002|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
11145187|NCT01846299|EG000|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
11145188|NCT01846299|EG001|Reported Event|Sham With Ranibizumab 0.5mg|Sham with Ranibizumab 0.5mg
11145189|NCT01846299|EG002|Reported Event|Sham Without Ranibizumab 0.5mg|Sham without Ranibizumab 0.5mg
11145190|NCT01846416|BG000|Baseline|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
11145191|NCT01846416|BG001|Baseline|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
11145192|NCT01846416|BG002|Baseline|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
11145193|NCT01846416|BG003|Baseline|Total|Total of all reporting groups
11145194|NCT01846416|FG000|Participant Flow|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
11145195|NCT01846416|FG001|Participant Flow|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
11145196|NCT01846416|FG002|Participant Flow|Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
11145197|NCT01846416|OG000|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
11145198|NCT01846416|OG001|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
10879792|NCT00459953|FG001|Participant Flow|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
10879793|NCT00459953|OG000|Outcome|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
10879794|NCT00459953|OG001|Outcome|Control Group|Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
11348803|NCT04147442|OG000|Outcome|Music Program Fine-tuned|"The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings.~The participants will perform the test with the fine-tuned music program."
11224890|NCT02363959|OG000|Outcome|Hyperbaric Oxygen, Airway Biopsy|"The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.~During standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure."
10879795|NCT00459953|EG000|Reported Event|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
11224891|NCT02363959|OG001|Outcome|No Hyperbaric Oxygen, Airway Biopsy|"No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.~Endobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung."
11145199|NCT01846416|OG002|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
11145200|NCT01846416|OG000|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
10879796|NCT00459953|EG001|Reported Event|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
11145201|NCT01846416|EG000|Reported Event|Atezolizumab (MPDL3280A) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
11145202|NCT01846416|EG001|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
11145203|NCT01846416|EG002|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
11145204|NCT01846442|BG000|Baseline|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145205|NCT01846442|BG001|Baseline|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145206|NCT01846442|BG002|Baseline|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145207|NCT01846442|BG003|Baseline|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145208|NCT01846442|BG004|Baseline|Total|Total of all reporting groups
11145209|NCT01846442|FG000|Participant Flow|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145210|NCT01846442|FG001|Participant Flow|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145211|NCT01846442|FG002|Participant Flow|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145212|NCT01846442|FG003|Participant Flow|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145213|NCT01846442|OG000|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145214|NCT01846442|OG001|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145215|NCT01846442|OG002|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145216|NCT01846442|OG003|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145217|NCT01846442|EG000|Reported Event|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145218|NCT01846442|EG001|Reported Event|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145219|NCT01846442|EG002|Reported Event|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145220|NCT01846442|EG003|Reported Event|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
11145221|NCT01846455|BG000|Baseline|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145222|NCT01846455|BG001|Baseline|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145223|NCT01846455|BG002|Baseline|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145224|NCT01846455|BG003|Baseline|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145225|NCT01846455|BG004|Baseline|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145226|NCT01846455|BG005|Baseline|Total|Total of all reporting groups
11145227|NCT01846455|FG000|Participant Flow|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145228|NCT01846455|FG001|Participant Flow|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145229|NCT01846455|FG002|Participant Flow|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145230|NCT01846455|FG003|Participant Flow|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145231|NCT01846455|FG004|Participant Flow|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145232|NCT01846455|OG000|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145233|NCT01846455|OG001|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145234|NCT01846455|OG002|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145235|NCT01846455|OG003|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145236|NCT01846455|OG004|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145237|NCT01846455|EG000|Reported Event|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145238|NCT01846455|EG001|Reported Event|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145239|NCT01846455|EG002|Reported Event|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145240|NCT01846455|EG003|Reported Event|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145241|NCT01846455|EG004|Reported Event|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
11145242|NCT01846494|BG000|Baseline|HCV Patients Not Exposed to BMS-986094|Hepatitis C patients without exposure to BMS-986094
11145243|NCT01846494|BG001|Baseline|Hepatitis C Virus (HCV) Patients Exposed to BMS-986094|Hepatitis C infected patients with previous exposure to BMS-986094
11145244|NCT01846494|BG002|Baseline|Total|Total of all reporting groups
11145245|NCT01846494|FG000|Participant Flow|HCV Patients Not Exposed to BMS-986094|Hepatitis C patients without exposure to BMS-986094
11145246|NCT01846494|FG001|Participant Flow|Hepatitis C Virus (HCV) Patients Exposed to BMS-986094|Hepatitis C infected patients with previous exposure to BMS-986094
11145247|NCT01846494|OG000|Outcome|HCV Patients Not Exposed to BMS-986094|Hepatitis C patients without exposure to BMS-986094
11145248|NCT01846494|OG001|Outcome|Hepatitis C Virus (HCV) Patients Exposed to BMS-986094|Hepatitis C infected patients with previous exposure to BMS-986094
11145249|NCT01846494|EG000|Reported Event|HCV Patients Not Exposed to BMS-986094|Hepatitis C patients without exposure to BMS-986094
11145250|NCT01846494|EG001|Reported Event|Hepatitis C Virus (HCV) Patients Exposed to BMS-986094|Hepatitis C infected patients with previous exposure to BMS-986094
11145251|NCT01846507|BG000|Baseline|Tranexamic Acid|Tranexamic Acid: Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.
11145252|NCT01846507|FG000|Participant Flow|Tranexamic Acid|Adolescent girls aged 10-19 years with heavy menstrual bleeding
11145253|NCT01846507|OG000|Outcome|Baseline Menses|Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment
11145254|NCT01846507|OG001|Outcome|Treated With Tranexamic Acid During Menses|Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
11145255|NCT01846507|OG000|Outcome|Baseline Menses|Adolescent girls aged 10-19 years with heavy menstrual bleeding - Baseline menses with no treatment
11145256|NCT01846507|EG000|Reported Event|Tranexamic Acid|Adolescent girls aged 10-19 years with heavy menstrual bleeding
11145257|NCT01846611|BG000|Baseline|Trabectedin + DOXIL|Participants received DOXIL 30 milligram per meter square (mg/m^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
11145258|NCT01846611|BG001|Baseline|DOXIL|Participants received DOXIL 50 mg/m^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
11145259|NCT01846611|BG002|Baseline|Total|Total of all reporting groups
11145260|NCT01846611|FG000|Participant Flow|Trabectedin + DOXIL|Participants received DOXIL 30 milligram per meter square (mg/m^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
11145261|NCT01846611|FG001|Participant Flow|DOXIL|Participants received DOXIL 50 mg/m^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
11145262|NCT01846611|OG000|Outcome|Trabectedin + DOXIL|Participants received DOXIL 30 milligram per meter square (mg/m^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
11145263|NCT01846611|OG001|Outcome|DOXIL|Participants received DOXIL 50 mg/m^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
11145264|NCT01846611|EG000|Reported Event|Trabectedin + DOXIL|Participants received DOXIL 30 milligram per meter square (mg/m^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
11145265|NCT01846611|EG001|Reported Event|DOXIL|Participants received DOXIL 50 mg/m^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
11149892|NCT01874275|OG000|Outcome|VECTTOR|"nerve stimulator treatment twice daily for duration of study - 180 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
11145266|NCT01846624|BG000|Baseline|Decitabine, Then Midostaurin|"INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.~POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.~After completion of study treatment, patients are followed up for up to 1 year.~Decitabine: Given IV~Midostaurin: Given PO"
11145267|NCT01846624|FG000|Participant Flow|Decitabine, Then Midostaurin|"INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.~POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.~After completion of study treatment, patients are followed up for up to 1 year.~Decitabine: Given IV~Midostaurin: Given PO"
10879797|NCT00459979|BG000|Baseline|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
11342024|NCT03695094|OG001|Outcome|Group 2 (Neutral [Control]) (PK-PPS)|Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
10879798|NCT00459979|FG000|Participant Flow|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
10879799|NCT00459979|OG000|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
11145268|NCT01846624|OG000|Outcome|Decitabine, Then Midostaurin|"INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.~POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.~After completion of study treatment, patients are followed up for up to 1 year.~Decitabine: Given IV~Midostaurin: Given PO"
11145269|NCT01846624|EG000|Reported Event|Decitabine, Then Midostaurin|"INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.~POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.~After completion of study treatment, patients are followed up for up to 1 year.~Decitabine: Given IV~Midostaurin: Given PO"
11145270|NCT01846702|BG000|Baseline|Placebo Cohort 1|Single dose of placebo matching LY3084077 administered subcutaneously (SC).
11145271|NCT01846702|BG001|Baseline|LY3084077 Cohort 2|1 mg single dose of LY3084077 administered SC.
11145272|NCT01846702|BG002|Baseline|LY3084077 Cohort 3|3 mg single dose of LY3084077 administered SC.
11145273|NCT01846702|BG003|Baseline|LY3084077 Cohort 4|10 mg single dose of LY3074077 administered SC.
11145274|NCT01846702|BG004|Baseline|LY3084077 Cohort 5|30 mg single dose of LY3074077 administered SC.
11145275|NCT01846702|BG005|Baseline|LY3084077 Cohort 6|100 mg single dose of LY3074077 administered SC.
11145276|NCT01846702|BG006|Baseline|LY3084077 Cohort 7|150 mg single dose of LY3074077 administered SC.
11145277|NCT01846702|BG007|Baseline|Total|Total of all reporting groups
11145278|NCT01846702|FG000|Participant Flow|Placebo Cohort 1|Single dose of placebo matching LY3084077 administered subcutaneously (SC).
11145279|NCT01846702|FG001|Participant Flow|LY3084077 Cohort 2|1 mg single dose of LY3084077 administered SC.
11145280|NCT01846702|FG002|Participant Flow|LY3084077 Cohort 3|3 mg single dose of LY3084077 administered SC.
11145281|NCT01846702|FG003|Participant Flow|LY3084077 Cohort 4|10 mg single dose of LY3084077 administered SC.
11145282|NCT01846702|FG004|Participant Flow|LY3084077 Cohort 5|30 mg single dose of LY3084077 administered SC.
11145283|NCT01846702|FG005|Participant Flow|LY3084077 Cohort 6|100 mg single dose of LY3084077 administered SC.
11145284|NCT01846702|FG006|Participant Flow|LY3084077 Cohort 7|150 mg single dose of LY3084077 administered SC
11145285|NCT01846702|OG000|Outcome|Placebo Cohort 1|Single dose of placebo matching LY3084077 administered SC.
11145286|NCT01846702|OG001|Outcome|LY3084077 Cohort 2|1 mg single dose of LY3084077 administered SC.
11145287|NCT01846702|OG002|Outcome|LY3084077 Cohort 3|3 mg single dose of LY3084077 administered SC
11145288|NCT01846702|OG003|Outcome|LY3084077 Cohort 4|10 mg single dose of LY3084077 administered SC
11145289|NCT01846702|OG004|Outcome|LY3084077 Cohort 5|30 mg single dose of LY3084077 administered SC
11145290|NCT01846702|OG005|Outcome|LY3084077 Cohort 6|100 mg single dose of LY3084077 administered SC
11145291|NCT01846702|OG006|Outcome|LY3084077 Cohort 7|150 mg single dose of LY3084077 administered SC
11145292|NCT01846702|OG002|Outcome|LY3084077 Cohort 3|3mg single dose of LY3084077 administered SC.
11145293|NCT01846702|OG003|Outcome|LY3084077 Cohort 4|10 mg single dose of LY3084077 administered SC.
11145294|NCT01846702|OG004|Outcome|LY3084077 Cohort 5|30 mg single dose of LY3084077 administered SC.
11145295|NCT01846702|OG005|Outcome|LY3084077 Cohort 6|100 mg single dose of LY3084077 administered SC.
11145296|NCT01846702|OG006|Outcome|LY3084077 Cohort 7|150 mg single dose of LY3084077 administered SC.
11145297|NCT01846702|OG000|Outcome|Placebo Cohort 1|Single dose of placebo matching LY3084077 administered SC
11145298|NCT01846702|OG001|Outcome|LY3084077 Cohort 2|1 mg single dose of LY3084077 administered SC
11145299|NCT01846702|OG002|Outcome|LY3084077 Cohort 3|3 mg single dose of LY3084077 administered SC.
11145300|NCT01846702|EG000|Reported Event|Placebo Cohort 1|Single dose of placebo matching LY3084077 administered SC.
11145301|NCT01846702|EG001|Reported Event|LY3084077 Cohort 2|1 mg single dose of LY3084077 administered SC.
11145302|NCT01846702|EG002|Reported Event|LY3084077 Cohort 3|3 mg single dose of LY3084077 administered SC
11145303|NCT01846702|EG003|Reported Event|LY3084077 Cohort 4|10 mg single dose of LY3084077 administered SC
11145304|NCT01846702|EG004|Reported Event|LY3084077 Cohort 5|30 mg single dose of LY3084077 administered SC
11145305|NCT01846702|EG005|Reported Event|LY3084077 Cohort 6|100 mg single dose of LY3084077 administered SC
11145306|NCT01846702|EG006|Reported Event|LY3084077 Cohort 7|150 mg single dose of LY3084077 administered SC
11145307|NCT01846728|BG000|Baseline|Estrogen Suppression|"Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones~Estrogen suppression: Participants underwent 3 mo of ovarian hormone suppression using the GnRHAG leuprolide acetate (Lupron; TAP Pharmaceutical Products, Inc; Lake Forest, IL) delivered by monthly intramuscular injection (3.75 mg)."
11145308|NCT01846728|FG000|Participant Flow|Estrogen Suppression|"Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones~Estrogen suppression: Participants underwent 3 mo of ovarian hormone suppression using the GnRHAG leuprolide acetate (Lupron; TAP Pharmaceutical Products, Inc; Lake Forest, IL) delivered by monthly intramuscular injection (3.75 mg)."
10879800|NCT00459979|EG000|Reported Event|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
10879801|NCT00460031|BG000|Baseline|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
11145309|NCT01846728|OG000|Outcome|Estrogen Suppression|"Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones~Estrogen suppression: Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function"
11224892|NCT02363959|EG000|Reported Event|Hyperbaric Oxygen, Airway Biopsy|"The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.~During standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure."
11224893|NCT02363959|EG001|Reported Event|No Hyperbaric Oxygen, Airway Biopsy|"No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.~Endobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung."
11224894|NCT02363972|BG000|Baseline|Ellipsys Vascular Access Catheter|"ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula.~Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae."
11224895|NCT02363972|FG000|Participant Flow|Ellipsys Vascular Access Catheter|"ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula.~Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae."
11224896|NCT02363972|OG000|Outcome|Ellipsys Vascular Access Catheter|"ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula.~Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae."
11224897|NCT02363972|EG000|Reported Event|Ellipsys Vascular Access Catheter|"ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula.~Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae."
11224898|NCT02364037|BG000|Baseline|Phase 1: Enhanced Care|Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs.
11224899|NCT02364037|BG001|Baseline|Phase 2: Complete CHOICE|Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage.
11224900|NCT02364037|BG002|Baseline|Total|Total of all reporting groups
11224901|NCT02364037|FG000|Participant Flow|Phase 1: Enhanced Care|Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs.
11224902|NCT02364037|FG001|Participant Flow|Phase 2: Complete CHOICE|Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for intrauterine devices (IUDs) and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage.
11224903|NCT02364037|OG000|Outcome|Phase 1: Enhanced Care|Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs.
11224904|NCT02364037|OG001|Outcome|Phase 2: Complete CHOICE|Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage.
11224905|NCT02364037|EG000|Reported Event|Phase 1: Enhanced Care|Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs.
11224906|NCT02364037|EG001|Reported Event|Phase 2: Complete CHOICE|Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage.
11224907|NCT02364076|BG000|Baseline|Pembrolizumab and Epacadostat|Pembrolizumab 200 mg intrvenoulsy every 3 weels
11224908|NCT02364076|FG000|Participant Flow|Pembrolizumab and Epacadostat|Pembrolizumab 200 mg intrvenoulsy every 3 weels
11224909|NCT02364076|OG000|Outcome|Pembrolizumab|Pembrolizumab 200 mg intrvenoulsy every 3 weeks
11224910|NCT02364076|EG000|Reported Event|Pembrolizumab and Epacadostat|"Pembrolizumab 200 mg intravenously every 3 weeks Epacadostat 100mg by mouth taken daily~Pembrolizumab: Administration of 200 mg MK-3475 once every 3 weeks~Epacadostat: 100mg taken by mouth twice daily"
11145310|NCT01846728|EG000|Reported Event|Estrogen Suppression|"Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones~Estrogen suppression: Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function"
11145311|NCT01846741|BG000|Baseline|VNS Therapy (ITT Population)|Subjects who were implanted with the AspireSR® VNS Therapy® System.
11145312|NCT01846741|FG000|Participant Flow|VNS Therapy - ITT Population|"Subjects who were implanted with the AspireSR® VNS Therapy® System.~The intent-to-treat (ITT) population is defined as all subjects with the VNS Therapy system implanted and the device had been turned on."
10879802|NCT00460031|FG000|Participant Flow|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
11145313|NCT01846741|OG000|Outcome|Reported By Investigators|All Seizures Identified (During EMU)
11224911|NCT02364180|BG000|Baseline|Pyridostigmine Bromide Treatment Group|All subjects investigated were taking pyridostigmine.
11224912|NCT02364180|FG000|Participant Flow|Pyridostigmine Bromide Treatment Group|pyridostigmine bromide treatment is a single arm. Subjects must be treated with pyridostigmine for at least 6months and must not be treated for myasthenia gravis.
11224913|NCT02364180|OG000|Outcome|Pyridostigmine Bromide Treatment Group|Subjects taking pyridostigmine bromide for more than 6 months for a condition other than myasthenia gravis
11224914|NCT02364180|EG000|Reported Event|Pyridostigmine Bromide Treatment Group|In all enrolled subjects (10), who were known pyridostigmine bromide pts that were observed with Electromyography (EMG), there were no adverse events anticipated.
11224915|NCT02364271|BG000|Baseline|High Risk Group|Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI>0 and mHEART>2
11224916|NCT02364271|BG001|Baseline|Low Risk Group|Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI=0 or mHEART<=2
11224917|NCT02364271|BG002|Baseline|Total|Total of all reporting groups
11224918|NCT02364271|FG000|Participant Flow|Not Low Risk Group|Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI>0 and mHEART>2
11224919|NCT02364271|FG001|Participant Flow|Low Risk Group|Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI=0 or mHEART<=2
11224920|NCT02364271|OG000|Outcome|Not Low Risk Groups|"Patients with modified TIMI>0 and modified HEART>2 were considered as high risk for 30-day MACE.~Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of >0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L."
11224921|NCT02364271|OG001|Outcome|Low Risk Group|"Patients with modified TIMI=0 or modified HEART<=2 were considered as low risk for 30-day MACE.~Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of >0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L."
11224922|NCT02364271|OG000|Outcome|Not Low Risk Group|"Patients with modified TIMI>0 and modified HEART>2 were considered as high risk for 30-day MACE.~Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of >0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L."
11224923|NCT02364271|EG000|Reported Event|Not Low Risk Group|Patients with modified TIMI>0 and modified HEART>2 were considered as high risk for 30-day MACE.
11224924|NCT02364271|EG001|Reported Event|Low Risk Group|Patients with modified TIMI=0 or modified HEART<=2 were considered as low risk for 30-day MACE.
11224925|NCT02364336|BG000|Baseline|HBeAg Positive|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
11224926|NCT02364336|BG001|Baseline|HBeAg Negative|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
11224927|NCT02364336|BG002|Baseline|Total|Total of all reporting groups
11224928|NCT02364336|FG000|Participant Flow|HBeAg Positive|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
11224929|NCT02364336|FG001|Participant Flow|HBeAg Negative|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
11224930|NCT02364336|OG000|Outcome|HBeAg Positive|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
11224931|NCT02364336|OG001|Outcome|HBeAg Negative|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
11224932|NCT02364336|OG001|Outcome|HBeAg Negative|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negative
11224933|NCT02364336|EG000|Reported Event|HBeAg Positive|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
11145314|NCT01846741|OG001|Outcome|Reported by Triple Review|EMU Seizures Identified Post EMU
11145315|NCT01846741|OG002|Outcome|Total|Seizures Reported by Investigators and Triple Reviewers
11145316|NCT01846741|OG000|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
11145317|NCT01846741|OG000|Outcome|During EMU Stay|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
11145318|NCT01846741|OG001|Outcome|During EMU Stay Stair-Stepper Exercise|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
11145319|NCT01846741|OG000|Outcome|Overall Seizures|During AutoStim Course in The EMU
11145320|NCT01846741|OG001|Outcome|Complex Partial Seizures|During AutoStim Course in The EMU
11145321|NCT01846741|OG002|Outcome|Secondary Generalized Seizures|During AutoStim Course in The EMU
11145322|NCT01846741|OG003|Outcome|Simple Partial Seizures|During AutoStim Course in The EMU
11145323|NCT01846741|OG004|Outcome|Sub-Clinical Seizures|During AutoStim Course in The EMU
11145324|NCT01846741|OG005|Outcome|Unknown Seizures|During AutoStim Course in The EMU
11145325|NCT01846741|OG000|Outcome|Complex Partial Seizure (CPS)|NHS3 Scores at Follow-Up Visits
11145326|NCT01846741|OG001|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-up Visits
11145327|NCT01846741|OG002|Outcome|Simple Partial Seizure (SPS)|NHS3 Scores at Follow-Up Visits
11145328|NCT01846741|OG000|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
11145329|NCT01846741|OG001|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
11145330|NCT01846741|OG002|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
11145331|NCT01846741|OG003|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
11145332|NCT01846741|OG000|Outcome|QOLIE-31-P Scores at 3-Months|Change From Baseline at Each Category
11145333|NCT01846741|OG001|Outcome|QOLIE-31-P Scores at 6-Months|Change From Baseline at Each Category
11145334|NCT01846741|OG002|Outcome|QOLIE-31-P Scores at 12-Months|Change From Baseline at Each Category
11145335|NCT01846741|OG003|Outcome|QOLIE-31-P Scores at 18-Months|Change From Baseline at Each Category
11145336|NCT01846741|OG000|Outcome|Partial Onset Seizure Responder Rate|Partial Onset Seizures (SPS, CPS, CPS with Secondary GTC)
11145337|NCT01846741|OG001|Outcome|Overall Seizure Responder Rate|Overall Seizure (All Seizure Types)
11145338|NCT01846741|OG000|Outcome|AED Load|Percent Change From Baseline by Visit
11145339|NCT01846741|OG000|Outcome|VNS Therapy|ITT Population
11145340|NCT01846741|OG000|Outcome|Number of Subjects|Experienced Adverse Events Greater Than 5% Incidence
11145341|NCT01846741|OG000|Outcome|Implant/Recovery|Users' Overall Assessment of Device Usability
11145342|NCT01846741|OG001|Outcome|EMU Day-1|Users' Overall Assessment of Device Usability
11145343|NCT01846741|OG002|Outcome|EMU Discharge|Users' Overall Assessment of Device Usability
11145344|NCT01846741|OG003|Outcome|6-Month Visit|Users' Overall Assessment of Device Usability
11145345|NCT01846741|OG000|Outcome|3-Month|Since Last Visit Assessment
11145346|NCT01846741|OG001|Outcome|6-Month|Since Last Visit Assessment
11145347|NCT01846741|OG002|Outcome|12-Month|Since Last Visit Assessment
11145348|NCT01846741|OG003|Outcome|18-Month|Since Last Visit Assessment
11145349|NCT01846741|EG000|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the end of study for all subjects treated/implanted with the AspireSR® VNS Therapy® system. Only the most common AEs (> 5%) are reported in the AE data table.
10879803|NCT00460031|OG000|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
11145350|NCT01846871|BG000|Baseline|Tivozanib|"1.5 mg daily for 3 weeks, with 1 week off.~Tivozanib"
11145351|NCT01846871|FG000|Participant Flow|Tivozanib|"1.5 mg daily for 3 weeks, with 1 week off.~Tivozanib"
11145352|NCT01846871|OG000|Outcome|Tivozanib|"1.5 mg daily for 3 weeks, with 1 week off.~Tivozanib"
11145353|NCT01846871|OG000|Outcome|Tivozanib (Baseline)|"1.5 mg daily for 3 weeks, with 1 week off.~Tivozanib"
11145354|NCT01846871|OG001|Outcome|Tivozanib (Cycle 1 Day 2)|1.5 mg daily for 3 weeks, with 1 week off.
11145355|NCT01846871|OG002|Outcome|Tivozanib (Pre-cycle 2)|1.5 mg daily for 3 weeks, with 1 week off.
11145356|NCT01846871|OG003|Outcome|Tivozanib (Pre-cycle 3)|1.5 mg daily for 3 weeks, with 1 week off.
11145357|NCT01846871|EG000|Reported Event|Tivozanib|"1.5 mg daily for 3 weeks, with 1 week off.~Tivozanib"
11145358|NCT01846988|BG000|Baseline|APAP Pressurized Comparison|"Comparison usage to determine APAP average 90% pressure (APAP P90) for initial treatment period and to assess adherence for randomization periods for 6-8 weeks or 4-6 weeks.~Subjects will then be randomized to Group 1 first, or Group 2 first, then crossover to the other group."
11145359|NCT01846988|BG001|Baseline|Group 1 Crossover Treatment|Randomized to APAP for 4 weeks followed by crossover to CPAP for 4 weeks after APAP settings for 4-8 weeks.
11145360|NCT01846988|BG002|Baseline|Group 2 Crossover Treatment|Randomized to CPAP for 4 weeks followed by crossover to APAP for 4 weeks after APAP settings for 4-8 weeks.
11145361|NCT01846988|BG003|Baseline|Total|Total of all reporting groups
11145362|NCT01846988|FG000|Participant Flow|APAP Pressurized Comparison|An in-hospital titration study will average 90th pressure percentile and average CPAP pressure derived from the device will be compared to the CPAP pressure determined by CPAP titration PSG. Subjects will then be randomized to Group 1 first, or Group 2 first, then crossover to the other group.
11145363|NCT01846988|FG001|Participant Flow|Group 1|Randomized to APAP for 4 weeks followed by crossover to CPAP for 4 weeks after APAP settings for 4-8 weeks.
11145364|NCT01846988|FG002|Participant Flow|Group 2|Randomized to CPAP for 4 weeks followed by crossover to APAP for 4 weeks after APAP settings for 4-8 weeks.
11145365|NCT01846988|OG000|Outcome|APAP Pressure Comparison|APAP pressure comparison period was 6-8 weeks. APAP average 90th pressure percentile derived from machine download was compared to CPAP pressure determined by CPAP titration PSG. Subjects will then be randomized to Group 1 first, or Group 2 first, then crossover to the other group.
11145366|NCT01846988|OG000|Outcome|Group 1|Combined APAP data regardless of the order of randomization
11145367|NCT01846988|OG001|Outcome|Group 2|Combined CPAP data regardless of order of randomization
11145368|NCT01846988|OG000|Outcome|Baseline|Michigan pediatric questionnaire score obtained at baseline at the time of enrollment into the study for subjects who were then randomized to APAP and CPAP.
11145369|NCT01846988|OG001|Outcome|Group 1|Michigan pediatric sleep questionnaire score administered after APAP randomization period regardless of the order of randomization.
11145370|NCT01846988|OG002|Outcome|Group 2|Michigan pediatric sleep questionnaire score administered after CPAP randomization period regardless of the order of randomization.
11145371|NCT01846988|OG000|Outcome|Baseline|Epworth sleepiness scale questionnaire data obtained at baseline at the time of enrollment into the study for subjects who were then randomized to APAP and CPAP.
11145372|NCT01846988|OG001|Outcome|Group 1|Epworth sleepiness scale questionnaire data administered after APAP randomization period regardless of the order of randomization.
11145373|NCT01846988|OG002|Outcome|Group 2|Epworth sleepiness scale questionnaire data administered after CPAP randomization period regardless of the order of randomization.
11145374|NCT01846988|OG000|Outcome|Baseline|Pediatric Quality of Life Inventory questionnaire data obtained at baseline at the time of enrollment into the study for subjects who were then randomized to APAP and CPAP.
11145375|NCT01846988|OG001|Outcome|Group 1|Pediatric Quality of Life Inventory questionnaire data administered after APAP randomization period regardless of the order of randomization.
11224934|NCT02364336|EG001|Reported Event|HBeAg Negative|Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
11224935|NCT02364388|BG000|Baseline|MAESTRO|Baseline Breast Imaging Reporting and Data System (BI-RADS) Score of 4a or 4b
11224936|NCT02364388|FG000|Participant Flow|Imagio OA/US|Imagio OA/US (opto-acoustic+gray-scale ultrasound)
11224937|NCT02364388|OG000|Outcome|MAESTRO|Baseline
11224938|NCT02364388|EG000|Reported Event|MAESTRO|Baseline
11342025|NCT03695094|OG000|Outcome|Group 1 (Inducers) (FAS)|Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Full Analysis Set (FAS).
11145376|NCT01846988|OG002|Outcome|Group 2|Pediatric Quality of Life Inventory questionnaire data administered after CPAP randomization period regardless of the order of randomization.
11224939|NCT02364570|BG000|Baseline|All Study Participants|All study participants received all 4 interventions in a randomized order (Oral Glucose Tolerance Test, Glucose with Whole Eggs, Glucose with Egg Whites, Glucose with Egg Yolks). We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. FMD will be performed intermittently post-ingestion of the test meal at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.
10879804|NCT00460031|EG000|Reported Event|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
11145377|NCT01846988|EG000|Reported Event|APAP Pressurized Comparison|"randomization periods for 6-8 weeks.~An in-hospital APAP titration study will average 90th pressure percentile and average CPAP pressure derived from the device will be compared to the CPAP pressure determined by CPAP titration PSG. Subjects will then be randomized to Group 1 first, or Group 2 first, then crossover to the other group."
11145378|NCT01846988|EG001|Reported Event|Group 1 Crossover Treatment|"crossover treatment (REMstar Auto A-Flex) Placed on REMstar Auto A-Flex machine with APAP settings for 4-8 weeks then randomized to 4 weeks APAP settings then 4 weeks CPAP settings.~crossover treatment (REMstar Auto A-Flex): All subjects will use same device with 4 week crossover of settings of APAP and CPAP"
11145379|NCT01846988|EG002|Reported Event|Group 2 Crossover Treatment|"crossover treatment (REMstar Auto A-Flex) Placed on REMstar Auto A-Flex machine with APAP settings for 4-8 weeks then randomized to 4 weeks CPAP settings then 4 weeks APAP settings.~crossover treatment (REMstar Auto A-Flex): All subjects will use same device with 4 week crossover of settings of APAP and CPAP"
11342026|NCT03695094|OG001|Outcome|Group 2 (Neutral [Control]) (FAS)|Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the FAS.
11145380|NCT01847001|BG000|Baseline|Propranolol + Neoadjuvant Chemotherapy|"Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment.~Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and~Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim).~If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab.~After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor.~DOT imaging will be done at 4 additional time points, including beo.~Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks."
11145381|NCT01847001|FG000|Participant Flow|Propranolol + Neoadjuvant Chemotherapy|"Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment.~Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and~Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim).~If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab.~After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor.~DOT imaging will be done at 4 additional time points, including beo.~Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks."
11145382|NCT01847001|OG000|Outcome|Propranolol + Neoadjuvant Chemotherapy|"Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment.~Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and~Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim).~If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab.~After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor.~DOT imaging will be done at 4 additional time points, including beo.~Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks."
11145383|NCT01847001|OG000|Outcome|Propranolol + Neoadjuvant Chemotherapy|"Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment.~Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and~Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim).~Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks."
11342027|NCT03695094|EG000|Reported Event|Group 1 (Inducers) (FAS)|Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Full Analysis Set (FAS).
10879805|NCT00460109|BG000|Baseline|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
10879806|NCT00460109|FG000|Participant Flow|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
10879807|NCT00460109|OG000|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
10879808|NCT00460109|EG000|Reported Event|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
10879809|NCT00460239|BG000|Baseline|All Study Participants|All Study Participants
10879810|NCT00460239|FG000|Participant Flow|Condition 1|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, B60, M15, M30, P.
10879811|NCT00460239|FG001|Participant Flow|Condition 2|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, M15, B48, P, B60, M30.
10879812|NCT00460239|FG002|Participant Flow|Condition 3|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, M30, B60, P, M15.
10879813|NCT00460239|FG003|Participant Flow|Condition 4|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, M15, B16, P, B32, M30, B48, B60.
10879814|NCT00460239|FG004|Participant Flow|Condition 5|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, M30, B32, P, B48, M15, B60.
10879815|NCT00460239|FG005|Participant Flow|Condition 6|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, P, B8, M30, B16, B32, P, B48, B60.
10879816|NCT00460239|FG006|Participant Flow|Condition 7|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M30, B8, P, B16, M15, B32, B48, B60.
10879817|NCT00460239|FG007|Participant Flow|Condition 8|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): P, M30, M15, B8, B16, B32, B48, B60.
10879818|NCT00460239|FG008|Participant Flow|Condition 9|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, B8, B16, B32, M30, P, B48, B60.
10879819|NCT00460239|OG000|Outcome|Placebo 0 mg|
10879820|NCT00460239|OG001|Outcome|Morphine 15 mg|
11009476|NCT01102374|BG001|Baseline|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
11009477|NCT01102374|BG002|Baseline|Total|Total of all reporting groups
11009478|NCT01102374|FG000|Participant Flow|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
11009479|NCT01102374|FG001|Participant Flow|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
11009480|NCT01102374|OG000|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
11009481|NCT01102374|OG001|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
11009482|NCT01102374|EG000|Reported Event|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
11009483|NCT01102374|EG001|Reported Event|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
10879821|NCT00460239|OG002|Outcome|Morphine 30 mg|
10879822|NCT00460239|OG003|Outcome|Buprenorphine 8 mg|
11009484|NCT01102413|BG000|Baseline|Monofer|"Injections or infusions~Monofer: Infusion or injections"
11009485|NCT01102413|BG001|Baseline|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
11009486|NCT01102413|BG002|Baseline|Total|Total of all reporting groups
11009487|NCT01102413|FG000|Participant Flow|Monofer|"Injections or infusions~Monofer: Infusion or injections"
11009488|NCT01102413|FG001|Participant Flow|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
11009489|NCT01102413|OG000|Outcome|Monofer|"Injections or infusions~Monofer: Infusion or injections"
11009490|NCT01102413|OG001|Outcome|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
11009491|NCT01102413|EG000|Reported Event|Monofer|"Injections or infusions~Monofer: Infusion or injections"
11009492|NCT01102413|EG001|Reported Event|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
11009493|NCT01102426|BG000|Baseline|Plitidepsin+Dexamethasone|"plitidepsin + dexamethasone combination~plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion."
11009494|NCT01102426|BG001|Baseline|Dexamethasone|"dexamethasone single agent~dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks."
11009495|NCT01102426|BG002|Baseline|Total|Total of all reporting groups
11066003|NCT01390818|BG000|Baseline|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066004|NCT01390818|BG001|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066005|NCT01390818|BG002|Baseline|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11224940|NCT02364570|FG000|Participant Flow|Glucose, Then Whole Egg, Then Egg White, Then Egg Yolk|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224941|NCT02364570|FG001|Participant Flow|Glucose, Then Egg White, Then Whole Egg, Then Egg Yolk|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224942|NCT02364570|FG002|Participant Flow|Glucose, Then Egg Yolk, Then Egg White, Then Whole Egg|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224943|NCT02364570|FG003|Participant Flow|Glucose, Then Egg Yolk, Then Whole Egg, Then Egg White|We will perform fasting measurements of flow-mediated We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224944|NCT02364570|FG004|Participant Flow|Glucose, Then Whole Egg, Then Egg Yolk, Then Egg White|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224945|NCT02364570|FG005|Participant Flow|Glucose, Then Egg White, Then Egg Yolk, Then Whole Egg|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224946|NCT02364570|FG006|Participant Flow|Whole Egg, Then Egg White, Then Egg Yolk, Then Glucose|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224947|NCT02364570|FG007|Participant Flow|Whole Egg, Then Egg Yolk, Then Egg White, Then Glucose|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224948|NCT02364570|FG008|Participant Flow|Whole Egg, Then Glucose, Then Egg Yolk, Then Egg White|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224949|NCT02364570|FG009|Participant Flow|Egg White, Then Glucose, Then Whole Egg, Then Egg Yolk|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
10879823|NCT00460239|OG004|Outcome|Buprenorphine 16 mg|
10879824|NCT00460239|OG005|Outcome|Buprenorphine 32 mg|
10879825|NCT00460239|OG006|Outcome|Buprenorphine 48 mg|
10879826|NCT00460239|OG007|Outcome|Buprenorphine 60 mg|
10879827|NCT00460239|EG000|Reported Event|Placebo Intervention|
10879828|NCT00460239|EG001|Reported Event|Morphine Intervention|
10879829|NCT00460239|EG002|Reported Event|Buprenorphine Intervention|
11145384|NCT01847001|EG000|Reported Event|Propranolol + Neoadjuvant Chemotherapy|"Subjects will receive 2 types of chemotherapy regimens plus propranolol treatment.~Regimen I, involves paclitaxel (may be substituted with nab-paclitaxel; maybe given with premedication), and~Regimen II involves doxorubicin (maybe given with anti-nausea therapy) and cyclophosphamide (maybe given with Pegfilgrastim).~If your tumor is HER2 positive, you will also receive trastuzumab and pertuzumab.~After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor.~DOT imaging will be done at 4 additional time points, including beo.~Propranolol: Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks."
11145385|NCT01847014|BG000|Baseline|Macitentan|Macitentan tablet, dose of 10 mg, once daily.
11145386|NCT01847014|FG000|Participant Flow|Macitentan|Macitentan tablet, dose of 10 mg, once daily.
11145387|NCT01847014|OG000|Outcome|Macitentan|Macitentan tablet, dose of 10 mg, once daily.
11145388|NCT01847014|EG000|Reported Event|Macitentan|Macitentan tablet, dose of 10 mg, once daily.
11145389|NCT01847027|BG000|Baseline|Active Supplement|"NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).~NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.~Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
11145390|NCT01847027|BG001|Baseline|Sugar Pill|"The placebo is identical in appearance to the NutraStem® supplement and contains the following ingredients in a Vegi Capsule:~MCC200 DICALCIUM PHOSPHATE BROWN LAKE BLEND (SENSIENT # 09127 ) RED DYE DB-088 (COLORCON) MAGNESIUM STEARATE BLUE #1 ALUM LAKE (POWDER)~Placebo: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
11145391|NCT01847027|BG002|Baseline|Total|Total of all reporting groups
11145392|NCT01847027|FG000|Participant Flow|Active Supplement|"NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).~NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.~Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
11145393|NCT01847027|FG001|Participant Flow|Sugar Pill|"The placebo is identical in appearance to the NutraStem® supplement and contains the following ingredients in a Vegi Capsule:~MCC200 DICALCIUM PHOSPHATE BROWN LAKE BLEND (SENSIENT # 09127 ) RED DYE DB-088 (COLORCON) MAGNESIUM STEARATE BLUE #1 ALUM LAKE (POWDER)~Placebo: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
11145394|NCT01847027|OG000|Outcome|Active Supplement|"NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).~NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.~Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
11145395|NCT01847027|OG001|Outcome|Sugar Pill|"The placebo is identical in appearance to the NutraStem® supplement and contains the following ingredients in a Vegi Capsule:~MCC200 DICALCIUM PHOSPHATE BROWN LAKE BLEND (SENSIENT # 09127 ) RED DYE DB-088 (COLORCON) MAGNESIUM STEARATE BLUE #1 ALUM LAKE (POWDER)~Placebo: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
10879830|NCT00460265|BG000|Baseline|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
10879831|NCT00460265|BG001|Baseline|Chemotherapy Alone|Consists of Cisplatin and 5-FU
10879832|NCT00460265|BG002|Baseline|Total|Total of all reporting groups
10879833|NCT00460265|FG000|Participant Flow|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
10879834|NCT00460265|FG001|Participant Flow|Chemotherapy Alone|Consists of Cisplatin and 5-FU
11342028|NCT03695094|EG001|Reported Event|Group 2 (Neutral [Control]) (FAS)|Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the FAS.
10879835|NCT00460265|OG000|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
10879836|NCT00460265|OG001|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
10879837|NCT00460265|EG000|Reported Event|Panitumumab Plus Chemotherapy|
10879838|NCT00460265|EG001|Reported Event|Chemotherapy Alone|
11145396|NCT01847027|EG000|Reported Event|Active Supplement|"NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).~NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.~Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
11145397|NCT01847027|EG001|Reported Event|Sugar Pill|"The placebo is identical in appearance to the NutraStem® supplement and contains the following ingredients in a Vegi Capsule:~MCC200 DICALCIUM PHOSPHATE BROWN LAKE BLEND (SENSIENT # 09127 ) RED DYE DB-088 (COLORCON) MAGNESIUM STEARATE BLUE #1 ALUM LAKE (POWDER)~Placebo: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
11145398|NCT01847092|BG000|Baseline|AZD1722|"AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks~AZD1722"
11145399|NCT01847092|BG001|Baseline|Placebo|"Placebo capsule BID PO for 12 Weeks~Placebo: Placebo for AZD1722"
11145400|NCT01847092|BG002|Baseline|Total|Total of all reporting groups
11145401|NCT01847092|FG000|Participant Flow|AZD1722|"AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks~AZD1722"
11145402|NCT01847092|FG001|Participant Flow|Placebo|"Placebo capsule BID PO for 12 Weeks~Placebo: Placebo for AZD1722"
11145403|NCT01847092|OG000|Outcome|AZD1722|"AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks~AZD1722"
11145404|NCT01847092|OG001|Outcome|Placebo|"Placebo capsule BID PO for 12 Weeks~Placebo: Placebo for AZD1722"
11145405|NCT01847092|EG000|Reported Event|AZD1722|"AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks~AZD1722"
11145406|NCT01847092|EG001|Reported Event|Placebo|"Placebo capsule BID PO for 12 Weeks~Placebo: Placebo for AZD1722"
11224950|NCT02364570|FG010|Participant Flow|Egg White, Then Egg Yolk, Then Whole Egg, Then Glucose|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11342029|NCT03695367|BG000|Baseline|Cohort 1: HTX-011 + MMA Regimen|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
11145407|NCT01847131|BG000|Baseline|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
10879839|NCT00460408|BG000|Baseline|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
11145408|NCT01847131|BG001|Baseline|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
11145409|NCT01847131|BG002|Baseline|Total|Total of all reporting groups
11145410|NCT01847131|FG000|Participant Flow|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
11145411|NCT01847131|FG001|Participant Flow|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
11145412|NCT01847131|OG000|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
11145413|NCT01847131|OG001|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
11145414|NCT01847131|EG000|Reported Event|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
11145415|NCT01847131|EG001|Reported Event|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
11145416|NCT01847196|BG000|Baseline|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
11145417|NCT01847196|FG000|Participant Flow|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
11145418|NCT01847196|OG000|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
11342030|NCT03695367|BG001|Baseline|Cohort 2: HTX-011 + MMA Regimen + Ketorolac|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
11145419|NCT01847196|EG000|Reported Event|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
11342031|NCT03695367|BG002|Baseline|Total|Total of all reporting groups
10879840|NCT00460408|BG001|Baseline|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
10879841|NCT00460408|BG002|Baseline|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
11145420|NCT01847209|BG000|Baseline|CT Marking and VATS Lung Wedge Resection|"Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.~Video-Assisted Thoracic Surgery (VATS) wedge resection"
11145421|NCT01847209|FG000|Participant Flow|CT Marking and VATS Lung Wedge Resection|"Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.~Video-Assisted Thoracic Surgery (VATS) wedge resection"
10879842|NCT00460408|BG003|Baseline|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
10879843|NCT00460408|BG004|Baseline|Total|Total of all reporting groups
10879844|NCT00460408|FG000|Participant Flow|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
11342032|NCT03695367|FG000|Participant Flow|Cohort 1: HTX-011 + MMA Regimen|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
11145422|NCT01847209|OG000|Outcome|CT Marking and VATS Lung Wedge Resection|"Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.~Video-Assisted Thoracic Surgery (VATS) wedge resection"
11145423|NCT01847209|EG000|Reported Event|CT Marking and VATS Lung Wedge Resection|"Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.~Video-Assisted Thoracic Surgery (VATS) wedge resection"
11145424|NCT01847313|BG000|Baseline|Liraglutide|Liraglutide 0.6 mg daily administration for 6 months
11145425|NCT01847313|BG001|Baseline|Control|Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist
11145426|NCT01847313|BG002|Baseline|Total|Total of all reporting groups
11145427|NCT01847313|FG000|Participant Flow|Liraglutide|Liraglutide 0.6 mg daily administration for 6 months
11145428|NCT01847313|FG001|Participant Flow|Control|Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist
11145429|NCT01847313|OG000|Outcome|Liraglutide|Liraglutide 0.6 mg daily administration for 6 months
11145430|NCT01847313|OG001|Outcome|Control|Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist
11145431|NCT01847313|EG000|Reported Event|Liraglutide|Liraglutide 0.6 mg daily administration for 6 months
11145432|NCT01847313|EG001|Reported Event|Control|Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist
11149893|NCT01874275|OG001|Outcome|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
11149894|NCT01874275|OG000|Outcome|VECTTOR|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.
11149895|NCT01874275|OG000|Outcome|VECTTOR|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.
11149896|NCT01874275|EG000|Reported Event|VECTTOR|nerve stimulator treatment twice daily for duration of study - 365 days ...
11149897|NCT01874275|EG001|Reported Event|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
11149898|NCT01874288|BG000|Baseline|DI-Leu16-IL2 0.5 mg/m^2|Participants received DI-Leu16-IL2 0.5 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11149899|NCT01874288|BG001|Baseline|DI-Leu16-IL2 1.0 mg/m^2|Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11145433|NCT01847430|BG000|Baseline|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11145434|NCT01847430|FG000|Participant Flow|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11145435|NCT01847430|OG000|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11145436|NCT01847430|EG000|Reported Event|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11145437|NCT01847443|BG000|Baseline|Total Participants|
11149900|NCT01874288|BG002|Baseline|DI-Leu16-IL2 2.0 mg/m^2|Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11145438|NCT01847443|FG000|Participant Flow|2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum|Participants randomly received 2mg nicotine mint gum or 4mg reference (ref) nicotine gum or 4mg nicotine mint gum or 2mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
11145439|NCT01847443|FG001|Participant Flow|4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum|Participants randomly received 4mg ref nicotine gum or 2mg ref nicotine gum or 2mg nicotine mint gum or 4mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
11149901|NCT01874288|BG003|Baseline|DI-Leu16-IL2 4.0 mg/m^2|Participants received DI-Leu16-IL2 4.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
10849320|NCT00295854|EG002|Reported Event|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
11145440|NCT01847443|FG002|Participant Flow|2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum|Participants randomly received 2mg ref nicotine gum or 4mg nicotine mint gum or 4mg ref nicotine gum or 2mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
11149902|NCT01874288|BG004|Baseline|DI-Leu16-IL2 6.0 mg/m^2|Participants received DI-Leu16-IL2 6.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11149903|NCT01874288|BG005|Baseline|Total|Total of all reporting groups
11149904|NCT01874288|FG000|Participant Flow|DI-Leu16-IL2 0.5 mg/m^2|Participants received DI-Leu16-IL2 0.5 milligrams per square meter (mg/m^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11224951|NCT02364570|FG011|Participant Flow|Whole Egg, Then Glucose, Then Egg White, Then Egg Yolk|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
10849321|NCT00295867|BG000|Baseline|Zoledronic Acid|Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
11145441|NCT01847443|FG003|Participant Flow|4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum|Participants randomly received 4mg nicotine mint gum or 2mg nicotine mint gum or 2mg ref nicotine gum or 4mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
11145442|NCT01847443|OG000|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
11145443|NCT01847443|OG001|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
11145444|NCT01847443|OG002|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
11145445|NCT01847443|OG003|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
11145446|NCT01847443|OG000|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
11145447|NCT01847443|OG001|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
11145448|NCT01847443|EG000|Reported Event|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
11145449|NCT01847443|EG001|Reported Event|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
11145450|NCT01847443|EG002|Reported Event|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
11145451|NCT01847443|EG003|Reported Event|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
11145452|NCT01847469|BG000|Baseline|Zonisamide|"Participants in this arm will receive zonisamide for 12 weeks.~Enhanced-Cognitive Processing Therapy-C (E-CPT-C)~Zonisamide"
11145453|NCT01847469|BG001|Baseline|Placebo|"Participants in this arm will receive placebo medication for 12 weeks.~Enhanced-Cognitive Processing Therapy-C (E-CPT-C)~Placebo"
11145454|NCT01847469|BG002|Baseline|Total|Total of all reporting groups
11145455|NCT01847469|FG000|Participant Flow|Zonisamide|"Participants in this arm will receive zonisamide for 12 weeks.~Enhanced-Cognitive Processing Therapy-C (E-CPT-C)~Zonisamide"
11145456|NCT01847469|FG001|Participant Flow|Placebo|"Participants in this arm will receive placebo medication for 12 weeks.~Enhanced-Cognitive Processing Therapy-C (E-CPT-C)~Placebo"
11145457|NCT01847469|OG000|Outcome|Zonisamide|"Participants in this arm will receive zonisamide for 12 weeks.~Enhanced-Cognitive Processing Therapy-C (E-CPT-C)~Zonisamide"
11145458|NCT01847469|OG001|Outcome|Placebo|"Participants in this arm will receive placebo medication for 12 weeks.~Enhanced-Cognitive Processing Therapy-C (E-CPT-C)~Placebo"
11145459|NCT01847469|EG000|Reported Event|Zonisamide|"Participants in this arm will receive zonisamide for 12 weeks.~Enhanced-Cognitive Processing Therapy-C (E-CPT-C)~Zonisamide"
11145460|NCT01847469|EG001|Reported Event|Placebo|"Participants in this arm will receive placebo medication for 12 weeks.~Enhanced-Cognitive Processing Therapy-C (E-CPT-C)~Placebo"
11145461|NCT01847547|BG000|Baseline|Dabigatran|Propensity score matched patients starting treatment with dabigatran
11145462|NCT01847547|BG001|Baseline|Warfarin|Propensity score matched patients starting treatment with warfarin
11145463|NCT01847547|BG002|Baseline|Total|Total of all reporting groups
11145464|NCT01847547|FG000|Participant Flow|Dabigatran|Propensity score matched patients starting treatment with dabigatran
11145465|NCT01847547|FG001|Participant Flow|Warfarin|Propensity score matched patients starting treatment with warfarin
11145466|NCT01847547|OG000|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
11224952|NCT02364570|FG012|Participant Flow|Egg Yolk, Then Egg White, Then Whole Egg, Then Glucose|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224953|NCT02364570|FG013|Participant Flow|Egg Yolk, Then Whole Egg, Then Glucose, Then Egg White|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224954|NCT02364570|FG014|Participant Flow|Egg Yolk, Then Glucose, Then Egg White, Then Whole Egg|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11145467|NCT01847547|OG001|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
11145468|NCT01847547|OG001|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
11145469|NCT01847547|EG000|Reported Event|Dabigatran|Propensity score matched patients starting treatment with dabigatran
10849322|NCT00295867|FG000|Participant Flow|Zoledronic Acid|Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
11145470|NCT01847547|EG001|Reported Event|Warfarin|Propensity score matched patients starting treatment with warfarin
11145471|NCT01847560|BG000|Baseline|Cohort UnitedHealth Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145472|NCT01847560|BG001|Baseline|Cohort UnitedHealth Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145473|NCT01847560|BG002|Baseline|Cohort UnitedHealth Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145474|NCT01847560|BG003|Baseline|Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145475|NCT01847560|BG004|Baseline|Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145476|NCT01847560|BG005|Baseline|Cohort MarketScan Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145477|NCT01847560|BG006|Baseline|Cohort MarketScan Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145478|NCT01847560|BG007|Baseline|Cohort MarketScan Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145479|NCT01847560|BG008|Baseline|Cohort MarketScan WarfarinUsers (After Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145480|NCT01847560|BG009|Baseline|Cohort MarketScan WarfarinUsers(Before Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145481|NCT01847560|BG010|Baseline|Total|Total of all reporting groups
11145482|NCT01847560|FG000|Participant Flow|Cohort UnitedHealth Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145483|NCT01847560|FG001|Participant Flow|Cohort UnitedHealth Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145484|NCT01847560|FG002|Participant Flow|Cohort UnitedHealth Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145485|NCT01847560|FG003|Participant Flow|Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145486|NCT01847560|FG004|Participant Flow|Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145487|NCT01847560|FG005|Participant Flow|Cohort MarketScan Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145488|NCT01847560|FG006|Participant Flow|Cohort MarketScan Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145489|NCT01847560|FG007|Participant Flow|Cohort MarketScan Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145490|NCT01847560|FG008|Participant Flow|Cohort MarketScan WarfarinUsers (After Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145491|NCT01847560|FG009|Participant Flow|Cohort MarketScan WarfarinUsers(Before Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145492|NCT01847560|OG000|Outcome|Cohort UnitedHealth Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145493|NCT01847560|OG001|Outcome|Cohort UnitedHealth Warfarin Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145494|NCT01847560|OG002|Outcome|Cohort UnitedHealth Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145495|NCT01847560|OG003|Outcome|Cohort UnitedHealth Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145496|NCT01847560|OG004|Outcome|Cohort MarketScan Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145497|NCT01847560|OG005|Outcome|Cohort MarketScan Warfarin Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145498|NCT01847560|OG006|Outcome|Cohort MarketScan Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145499|NCT01847560|OG007|Outcome|Cohort MarketScan Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145500|NCT01847560|OG000|Outcome|Warfarin Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with Warfarin in source cohort.
11145501|NCT01847560|OG001|Outcome|Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with Dabigatran in source cohort.
11145502|NCT01847560|OG002|Outcome|Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with Rivaroxaban in source cohort.
11145503|NCT01847560|OG003|Outcome|Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with Apixaban in source cohort.
11145504|NCT01847560|OG000|Outcome|Cohort UnitedHealth Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with dabigatran in UnitedHealth cohort.
11145505|NCT01847560|OG001|Outcome|Cohort MarketScan Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with dabigatran in MarketScan cohort.
11145506|NCT01847560|OG000|Outcome|Cohort UnitedHealth Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with apixaban in UnitedHealth cohort.
11145507|NCT01847560|OG001|Outcome|Cohort MarketScan Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with apixaban in MarketScan cohort.
11145508|NCT01847560|OG000|Outcome|Cohort UnitedHealth Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with rivaroxaban in UnitedHealth cohort.
11145509|NCT01847560|OG001|Outcome|Cohort MarketScan Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with rivaroxaban in MarketScan cohort.
11149905|NCT01874288|FG001|Participant Flow|DI-Leu16-IL2 1.0 mg/m^2|Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11145510|NCT01847560|OG000|Outcome|Cohort UnitedHealth Dabigatran (Dabigatran vs Warfarin)|Patients exposed to dabigatran were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145511|NCT01847560|OG001|Outcome|Cohort UnitedHealth Warfarin (Warfarin vs Dabigatran)|Patients exposed to warfarin were matched to dabigatran on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11149906|NCT01874288|FG002|Participant Flow|DI-Leu16-IL2 2.0 mg/m^2|Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11145512|NCT01847560|OG002|Outcome|Cohort Unitedhealth Rivaroxaban (Rivaroxaban vs Warfarin)|Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145513|NCT01847560|OG003|Outcome|Cohort Unitedhealth Warfarin (Warfarin vs Rivaroxaban)|Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145514|NCT01847560|OG004|Outcome|Cohort Unitedhealth Apixaban (Apixaban vs Warfarin)|Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145515|NCT01847560|OG005|Outcome|Cohort Unitedhealth Warfarin (Warfarin vs Apixaban)|Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145516|NCT01847560|OG006|Outcome|Cohort MarketScan Dabigatran (Dabigatran vs Warfarin)|Patients exposed to dabigatran were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145517|NCT01847560|OG007|Outcome|Cohort MarketScan Warfarin (Warfarin vs Dabigatran)|Patients exposed to warfarin were matched to dabigatran on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145518|NCT01847560|OG008|Outcome|Cohort MarketScan Rivaroxaban (Rivaroxabna vs Warfarin)|Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145519|NCT01847560|OG009|Outcome|Cohort MarketScan Warfarin (Warfarin vs Rivaroxaban)|Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145520|NCT01847560|OG010|Outcome|Cohort MarketScan Apixaban (Apixaban vs Warfarin)|Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145521|NCT01847560|OG011|Outcome|Cohort MarketScan Warfarin (Warfarin vs Apixaban)|Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
11145522|NCT01847560|EG000|Reported Event|Cohort UnitedHealth Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145523|NCT01847560|EG001|Reported Event|Cohort UnitedHealth Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145524|NCT01847560|EG002|Reported Event|Cohort UnitedHealth Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145525|NCT01847560|EG003|Reported Event|Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145526|NCT01847560|EG004|Reported Event|Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
11145527|NCT01847560|EG005|Reported Event|Cohort MarketScan Dabigatran Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145528|NCT01847560|EG006|Reported Event|Cohort MarketScan Rivaroxaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145529|NCT01847560|EG007|Reported Event|Cohort MarketScan Apixaban Users|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145530|NCT01847560|EG008|Reported Event|Cohort MarketScan WarfarinUsers (After Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145531|NCT01847560|EG009|Reported Event|Cohort MarketScan WarfarinUsers(Before Dabigatran Available)|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
11145532|NCT01847638|BG000|Baseline|Prolensa (Bromfenac 0.07%)|"Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.~Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery"
11145533|NCT01847638|BG001|Baseline|Ilevro (Nepafenac 0.3%)|"Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.~Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery"
11145534|NCT01847638|BG002|Baseline|Total|Total of all reporting groups
11145535|NCT01847638|FG000|Participant Flow|Prolensa (Bromfenac 0.07%)|"Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.~Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery"
11145536|NCT01847638|FG001|Participant Flow|Ilevro (Nepafenac 0.3%)|"Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.~Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery"
11145537|NCT01847638|OG000|Outcome|Prolensa (Bromfenac 0.07%)|"Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.~Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery"
11145538|NCT01847638|OG001|Outcome|Ilevro (Nepafenac 0.3%)|"Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.~Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery"
11145539|NCT01847638|EG000|Reported Event|Prolensa (Bromfenac 0.07%)|"Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.~Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery"
11145540|NCT01847638|EG001|Reported Event|Ilevro (Nepafenac 0.3%)|"Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.~Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery"
11149907|NCT01874288|FG003|Participant Flow|DI-Leu16-IL2 4.0 mg/m^2|Participants received DI-Leu16-IL2 4.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11149908|NCT01874288|FG004|Participant Flow|DI-Leu16-IL2 6.0 mg/m^2|Participants received DI-Leu16-IL2 6.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11149909|NCT01874288|OG000|Outcome|DI-Leu16-IL2|Participants received assigned doses of DI-Leu16-IL2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11145541|NCT01847755|BG000|Baseline|120 Hyperbaric Treatments at 1.5 ATA|"Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure.~Oxygen at 1.5 ATA (atmospheres absolute).: Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40, 80, 120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment."
11145542|NCT01847755|FG000|Participant Flow|120 Hyperbaric Treatments at 1.5 ATA|"Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure.~Oxygen at 1.5 ATA (atmospheres absolute).: Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40, 80, 120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment."
11145543|NCT01847755|OG000|Outcome|120 Hyperbaric Treatments at 1.5 ATA|"Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure.~Oxygen at 1.5 ATA (atmospheres absolute).: Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40, 80, 120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment."
11145544|NCT01847755|EG000|Reported Event|120 Hyperbaric Treatments at 1.5 ATA|"Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure.~Oxygen at 1.5 ATA (atmospheres absolute).: Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40, 80, 120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment."
11145545|NCT01847885|BG000|Baseline|Smartpatch Treatment Group (Full Analysis Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
10849323|NCT00295867|OG000|Outcome|Zoledronic Acid|Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
11145546|NCT01847885|BG001|Baseline|Smartpatch Control Group (Full Analysis Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
11145547|NCT01847885|BG002|Baseline|Total|Total of all reporting groups
11145548|NCT01847885|FG000|Participant Flow|Enrolled Subjects|Subjects who signed a consent form.
11145549|NCT01847885|FG001|Participant Flow|Smartpatch Treatment Group (Full Analysis Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
11145550|NCT01847885|FG002|Participant Flow|Smartpatch Control Group (Full Analysis Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
10879845|NCT00460408|FG001|Participant Flow|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
10879846|NCT00460408|FG002|Participant Flow|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
11149910|NCT01874288|OG000|Outcome|DI-Leu16-IL2 0.5 mg/m^2|Participants received DI-Leu16-IL2 0.5 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11145551|NCT01847885|OG000|Outcome|Smartpatch Treatment Group (Full Analysis Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
11145552|NCT01847885|OG001|Outcome|Smartpatch Control Group (Full Analysis Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
11145553|NCT01847885|OG000|Outcome|Smartpatch Treatment Group (Safety Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
11145554|NCT01847885|OG001|Outcome|Smartpatch Control Group (Safety Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
11145555|NCT01847885|OG000|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
11145556|NCT01847885|OG001|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
11145557|NCT01847885|OG000|Outcome|Investigators|Investigator(s) at each site performing lead placement
11145558|NCT01847885|EG000|Reported Event|Enrolled Subjects Who Did Not Receive the Study Device|Subjects who were consented, but were not randomized and did not receive the study device or any intervention.
11145559|NCT01847885|EG001|Reported Event|Smartpatch Treatment Group (Safety Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
11145560|NCT01847885|EG002|Reported Event|Smartpatch Control Group (Safety Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
11145561|NCT01848041|BG000|Baseline|RVL-1201 QD|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145562|NCT01848041|BG001|Baseline|RVL-1201 BID|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145563|NCT01848041|BG002|Baseline|RVL-1201 Vehicle (Placebo) BID|"RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo"
11145564|NCT01848041|BG003|Baseline|Total|Total of all reporting groups
11145565|NCT01848041|FG000|Participant Flow|RVL-1201 QD|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145566|NCT01848041|FG001|Participant Flow|RVL-1201 BID|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145567|NCT01848041|FG002|Participant Flow|RVL-1201 Vehicle (Placebo) BID|"RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo"
11145568|NCT01848041|OG000|Outcome|RVL-1201 Once Daily|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145569|NCT01848041|OG001|Outcome|RVL-1201 Twice Daily|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145570|NCT01848041|OG002|Outcome|RVL-1201 Vehicle (Placebo)|"RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo"
11145571|NCT01848041|OG000|Outcome|RVL-1201 QD|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145572|NCT01848041|OG001|Outcome|RVL-1201 BID|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145573|NCT01848041|OG002|Outcome|RVL-1201 Vehicle (Placebo) BID|"RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo"
11145574|NCT01848041|EG000|Reported Event|RVL-1201 QD|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145575|NCT01848041|EG001|Reported Event|RVL-1201 BID|"RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201: RVL-1201 0.1% Ophthalmic Solution"
11145576|NCT01848041|EG002|Reported Event|RVL-1201 Vehicle (Placebo) BID|"RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose~RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo"
11145577|NCT01848054|BG000|Baseline|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
11145578|NCT01848054|BG001|Baseline|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
11145579|NCT01848054|BG002|Baseline|Total|Total of all reporting groups
11145580|NCT01848054|FG000|Participant Flow|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
11145581|NCT01848054|FG001|Participant Flow|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
10849324|NCT00295867|EG000|Reported Event|Zoledronic Acid|Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
10849325|NCT00295880|BG000|Baseline|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
11145582|NCT01848054|OG000|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
11145583|NCT01848054|OG001|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
11145584|NCT01848054|OG001|Outcome|Buprenorphine Induction|"Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)~OX219 buprenorphine/naloxone: OX219 buprenorphine/naloxone sublingual tablets~Buprenorphine: Buprenorphine sublingual tablets"
11145585|NCT01848054|OG000|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Day 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
11145586|NCT01848054|OG000|Outcome|BNX Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
11145587|NCT01848054|OG001|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)
11145588|NCT01848054|EG000|Reported Event|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
11145589|NCT01848054|EG001|Reported Event|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
10849326|NCT00295880|FG000|Participant Flow|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
11145590|NCT01848067|BG000|Baseline|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
10849327|NCT00295880|OG000|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
11145591|NCT01848067|FG000|Participant Flow|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
11149911|NCT01874288|OG001|Outcome|DI-Leu16-IL2 1.0 mg/m^2|Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11145592|NCT01848067|OG000|Outcome|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
11145593|NCT01848067|EG000|Reported Event|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
11149912|NCT01874288|OG002|Outcome|DI-Leu16-IL2 2.0 mg/m^2|Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11145594|NCT01848145|BG000|Baseline|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. The goal is to complete infusion #3 within 120 minutes (+/- 15 minutes).~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
11145595|NCT01848145|FG000|Participant Flow|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. .~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
11149913|NCT01874288|OG003|Outcome|DI-Leu16-IL2 4.0 mg/m^2|Participants received DI-Leu16-IL2 4.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
10849328|NCT00295880|EG000|Reported Event|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
10849329|NCT00295932|BG000|Baseline|1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide|Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849330|NCT00295932|BG001|Baseline|1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide|Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849331|NCT00295932|BG002|Baseline|1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide|Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849332|NCT00295932|BG003|Baseline|1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide|Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849333|NCT00295932|BG004|Baseline|Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid|Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849334|NCT00295932|BG005|Baseline|Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849335|NCT00295932|BG006|Baseline|Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849336|NCT00295932|BG007|Baseline|Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami|Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849337|NCT00295932|BG008|Baseline|Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
10849338|NCT00295932|BG009|Baseline|Weekly Bortezomib Dosing Schedule|Phase II Randomized Weekly bortezomib dosing schedule
10849339|NCT00295932|BG010|Baseline|Twice-weekly Bortezomib Dosing Schedule|Phase II Randomized Twice-weekly bortezomib dosing schedule
10849340|NCT00295932|BG011|Baseline|Total|Total of all reporting groups
10849341|NCT00295932|FG000|Participant Flow|1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide|Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849342|NCT00295932|FG001|Participant Flow|1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide|Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849343|NCT00295932|FG002|Participant Flow|1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide|Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849344|NCT00295932|FG003|Participant Flow|1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide|Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
11145596|NCT01848145|OG000|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
11145597|NCT01848145|EG000|Reported Event|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. The goal infusion time at Infusion #3 is 120 minutes.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
11149914|NCT01874288|OG004|Outcome|DI-Leu16-IL2 6.0 mg/m^2|Participants received DI-Leu16-IL2 6.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11149915|NCT01874288|EG000|Reported Event|DI-Leu16-IL2 0.5 mg/m^2|Participants received DI-Leu16-IL2 0.5 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
10849345|NCT00295932|FG004|Participant Flow|Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid|Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849346|NCT00295932|FG005|Participant Flow|Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849347|NCT00295932|FG006|Participant Flow|Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849348|NCT00295932|FG007|Participant Flow|Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami|Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849349|NCT00295932|FG008|Participant Flow|Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
10849350|NCT00295932|FG009|Participant Flow|Weekly Bortezomib Dosing Schedule|Phase II Randomized Weekly bortezomib dosing schedule
10849351|NCT00295932|FG010|Participant Flow|Twice-weekly Bortezomib Dosing Schedule|Phase II Randomized Twice-weekly bortezomib dosing schedule
11145598|NCT01848158|BG000|Baseline|Acupuncture|"Acupuncture treatment three times per week for up to two weeks.~acupuncture: Patients randomized to active treatment will receive acupuncture treatment with press needles (small acupuncture needles manufactured with attached bandage that makes the needle flush with skin) at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a seed magnet at ear shen men position for 4 hours on treatment days."
11149916|NCT01874288|EG001|Reported Event|DI-Leu16-IL2 1.0 mg/m^2|Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11149917|NCT01874288|EG002|Reported Event|DI-Leu16-IL2 2.0 mg/m^2|Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
10849352|NCT00295932|OG000|Outcome|Arm I|"Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2, 5, 9, and 12. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~bortezomib: Given IV~cyclophosphamide: Given IV~prednisone: Given orally"
10879847|NCT00460408|FG003|Participant Flow|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
10879848|NCT00460408|OG000|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
10879849|NCT00460408|OG001|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
10879850|NCT00460408|OG002|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
11348804|NCT04147442|OG001|Outcome|Music Standard Program|"The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings.~The participants will perform the test with the standard default music program."
10849353|NCT00295932|OG001|Outcome|Arm II|"Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~bortezomib: Given IV~cyclophosphamide: Given IV~prednisone: Given orally"
10849354|NCT00295932|OG000|Outcome|1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide|Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849355|NCT00295932|OG001|Outcome|1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide|Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
11145599|NCT01848158|BG001|Baseline|Sham Acupuncture|"Sham acupuncture three times per week for up to two weeks~sham acupuncture: Patients randomized to sham treatment will receive sham acupuncture with similarly appearing bandages placed without press needles attached at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a similarly appearing bandage without seed magnet underneath at ear shen men position for 4 hours on treatment days."
11145600|NCT01848158|BG002|Baseline|Total|Total of all reporting groups
11149918|NCT01874288|EG003|Reported Event|DI-Leu16-IL2 4.0 mg/m^2|Participants received DI-Leu16-IL2 4.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
10849356|NCT00295932|OG002|Outcome|1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide|Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849357|NCT00295932|OG003|Outcome|1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide|Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
11145601|NCT01848158|FG000|Participant Flow|Acupuncture|"Acupuncture treatment three times per week for up to two weeks.~acupuncture: Patients randomized to active treatment will receive acupuncture treatment with press needles (small acupuncture needles manufactured with attached bandage that makes the needle flush with skin) at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a seed magnet at ear shen men position for 4 hours on treatment days."
11145602|NCT01848158|FG001|Participant Flow|Sham Acupuncture|"Sham acupuncture three times per week for up to two weeks~sham acupuncture: Patients randomized to sham treatment will receive sham acupuncture with similarly appearing bandages placed without press needles attached at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a similarly appearing bandage without seed magnet underneath at ear shen men position for 4 hours on treatment days."
11145603|NCT01848158|OG000|Outcome|Acupuncture|"Acupuncture treatment three times per week for up to two weeks.~acupuncture: Patients randomized to active treatment will receive acupuncture treatment with press needles (small acupuncture needles manufactured with attached bandage that makes the needle flush with skin) at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a seed magnet at ear shen men position for 4 hours on treatment days."
11145604|NCT01848158|OG001|Outcome|Sham Acupuncture|"Sham acupuncture three times per week for up to two weeks~sham acupuncture: Patients randomized to sham treatment will receive sham acupuncture with similarly appearing bandages placed without press needles attached at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a similarly appearing bandage without seed magnet underneath at ear shen men position for 4 hours on treatment days."
11145605|NCT01848158|EG000|Reported Event|Acupuncture|"Acupuncture treatment three times per week for up to two weeks.~acupuncture: Patients randomized to active treatment will receive acupuncture treatment with press needles (small acupuncture needles manufactured with attached bandage that makes the needle flush with skin) at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a seed magnet at ear shen men position for 4 hours on treatment days."
11145606|NCT01848158|EG001|Reported Event|Sham Acupuncture|"Sham acupuncture three times per week for up to two weeks~sham acupuncture: Patients randomized to sham treatment will receive sham acupuncture with similarly appearing bandages placed without press needles attached at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a similarly appearing bandage without seed magnet underneath at ear shen men position for 4 hours on treatment days."
11145607|NCT01848184|BG000|Baseline|PARIETEX™ Composite Ventral Patch|"PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning~PARIETEX™ Composite Ventral Patch for ventral hernia repair"
11145608|NCT01848184|FG000|Participant Flow|PARIETEX™ Composite Ventral Patch|"PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning~PARIETEX™ Composite Ventral Patch for ventral hernia repair"
11145609|NCT01848184|OG000|Outcome|PARIETEX™ Composite Ventral Patch|"PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning~PARIETEX™ Composite Ventral Patch for ventral hernia repair"
11145610|NCT01848184|OG000|Outcome|Patients Undergoing Primary Ventral Hernia Repair|Patients undergoing primary ventral hernia repair using PARIETEX™ Composite Ventral Patch (PCO-VP)
11145611|NCT01848184|OG000|Outcome|Hernia Patients Receiving Surgery|Number of participants receiving surgery with PARIETEX™ Composite Ventral Patch for primary ventral hernia repair
11145612|NCT01848184|OG000|Outcome|Hernia Patients Enrolled at Baseline|All patients enrolled at Baseline and assessed for risk factors
10849358|NCT00295932|OG004|Outcome|Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid|Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849359|NCT00295932|OG005|Outcome|Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849360|NCT00295932|OG006|Outcome|Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849361|NCT00295932|OG007|Outcome|Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami|Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849362|NCT00295932|OG008|Outcome|Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
10849363|NCT00295932|OG009|Outcome|Weekly Bortezomib Dosing Schedule|Phase II Randomized Weekly bortezomib dosing schedule
11145613|NCT01848184|OG000|Outcome|Ease of Use|Ease of use (mesh handling and manipulability, comfort of use …)
11145614|NCT01848184|OG000|Outcome|Operative Time|Operative time during surgery
11145615|NCT01848184|OG000|Outcome|Time Mesh Positioning|Time positioning of the mesh
11145616|NCT01848184|EG000|Reported Event|PARIETEX™ Composite Ventral Patch|"PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning~PARIETEX™ Composite Ventral Patch for ventral hernia repair"
11145617|NCT01848210|BG000|Baseline|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
11145618|NCT01848210|BG001|Baseline|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
11145619|NCT01848210|BG002|Baseline|Total|Total of all reporting groups
11145620|NCT01848210|FG000|Participant Flow|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
11145621|NCT01848210|FG001|Participant Flow|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
11145622|NCT01848210|OG000|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
11145623|NCT01848210|OG001|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
11145624|NCT01848210|EG000|Reported Event|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
11145625|NCT01848210|EG001|Reported Event|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
11145626|NCT01848288|BG000|Baseline|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
11145627|NCT01848288|FG000|Participant Flow|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
11145628|NCT01848288|OG000|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
11145629|NCT01848288|OG001|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
11145630|NCT01848288|EG000|Reported Event|Overall|"First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group. For non-ocular adverse events, at risk population is included with unit of subjects. For ocular adverse events, at risk population is included with unit of eyes by treatment group."
11145631|NCT01848353|BG000|Baseline|Standard Payment, Phase 1|"All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145632|NCT01848353|BG001|Baseline|Incentivized Payment, Phase 1|"All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145633|NCT01848353|BG002|Baseline|Normal Weight, Low Activity Group|This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
11145634|NCT01848353|BG003|Baseline|Normal Weight, High Activity Group|This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
11145635|NCT01848353|BG004|Baseline|Total|Total of all reporting groups
11145636|NCT01848353|FG000|Participant Flow|Standard Payment|"All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11149919|NCT01874288|EG004|Reported Event|DI-Leu16-IL2 6.0 mg/m^2|Participants received DI-Leu16-IL2 6.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
11149920|NCT01874340|BG000|Baseline|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
10849364|NCT00295932|OG010|Outcome|Twice-weekly Bortezomib Dosing Schedule|Phase II Randomized Twice-weekly bortezomib dosing schedule
10849365|NCT00295932|EG000|Reported Event|1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide|Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
11149921|NCT01874340|BG001|Baseline|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11145637|NCT01848353|FG001|Participant Flow|Incentivized Payment|"All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1), or increase exercise duration (minutes per session) during weeks 17-32 (phase 2). In phase 3 the payment will be a lottery, with the number of lottery chances based on exercise frequency and duration. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11224955|NCT02364570|FG015|Participant Flow|Egg Yolk, Then Egg White, Then Glucose, Then Whole Egg|We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g), or glucose (75 g) + 1.5 cooked whole eggs, or glucose (75 g) + 7 egg whites, or glucose (75 g) + 2 egg yolks. FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal.
11224956|NCT02364570|OG000|Outcome|Oral Glucose Tolerance Test|"We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.~Glucose (100g): Ingestion of glucose (100g)"
11342033|NCT03695367|FG001|Participant Flow|Cohort 2: HTX-011 + MMA Regimen + Ketorolac|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
10849366|NCT00295932|EG001|Reported Event|1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide|Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
11342034|NCT03695367|OG000|Outcome|Cohort 1: HTX-011 + MMA Regimen|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
11145638|NCT01848353|FG002|Participant Flow|Normal Weight, Low Activity Group|This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
11145639|NCT01848353|FG003|Participant Flow|Normal Weight, High Activity Group|This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
10879851|NCT00460408|OG003|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
11145640|NCT01848353|OG000|Outcome|Standard Payment, Phase 1|"All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11149922|NCT01874340|BG002|Baseline|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
10879852|NCT00460408|EG000|Reported Event|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
11149923|NCT01874340|BG003|Baseline|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11149924|NCT01874340|BG004|Baseline|Total|Total of all reporting groups
11145641|NCT01848353|OG001|Outcome|Incentivized Payment, Phase 1|"All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145642|NCT01848353|OG002|Outcome|Standard Payment, Phase 2|"All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145643|NCT01848353|OG003|Outcome|Incentivized Payment, Phase 2|"All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145644|NCT01848353|OG004|Outcome|Ramp-down Payment, Phase 3|"All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145645|NCT01848353|OG005|Outcome|Raffle Payment, Phase 3|"All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145646|NCT01848353|OG006|Outcome|Normal Weight, Low Activity Group|This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
11145647|NCT01848353|OG007|Outcome|Normal Weight, High Activity Group|This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
11145648|NCT01848353|EG000|Reported Event|Standard Payment, Phase 1|"All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11149925|NCT01874340|FG000|Participant Flow|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
10849367|NCT00295932|EG002|Reported Event|1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide|Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849368|NCT00295932|EG003|Reported Event|1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide|Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849369|NCT00295932|EG004|Reported Event|Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid|Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
11149926|NCT01874340|FG001|Participant Flow|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
10849370|NCT00295932|EG005|Reported Event|Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
10849371|NCT00295932|EG006|Reported Event|Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
11149927|NCT01874340|FG002|Participant Flow|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11149928|NCT01874340|FG003|Participant Flow|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11149929|NCT01874340|OG000|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
10849372|NCT00295932|EG007|Reported Event|Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami|Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
10849373|NCT00295932|EG008|Reported Event|Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham|Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
10849374|NCT00295932|EG009|Reported Event|Weekly Bortezomib Dosing Schedule|Phase II Randomized Weekly bortezomib dosing schedule
10849375|NCT00295932|EG010|Reported Event|Twice-weekly Bortezomib Dosing Schedule|Phase II Randomized Twice-weekly bortezomib dosing schedule
10849376|NCT00296036|BG000|Baseline|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
11149930|NCT01874340|OG001|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
10849377|NCT00296036|BG001|Baseline|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
10849378|NCT00296036|BG002|Baseline|Total|Total of all reporting groups
10849379|NCT00296036|FG000|Participant Flow|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
10879853|NCT00460408|EG001|Reported Event|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
10879854|NCT00460408|EG002|Reported Event|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
11149931|NCT01874340|OG002|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11149932|NCT01874340|OG003|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11145649|NCT01848353|EG001|Reported Event|Incentivized Payment, Phase 1|"All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145650|NCT01848353|EG002|Reported Event|Standard Payment, Phase 2|"All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145651|NCT01848353|EG003|Reported Event|Incentivized Payment, Phase 2|"All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11149933|NCT01874340|EG000|Reported Event|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11149934|NCT01874340|EG001|Reported Event|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11149935|NCT01874340|EG002|Reported Event|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
11149936|NCT01874340|EG003|Reported Event|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
10879855|NCT00460408|EG003|Reported Event|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
11341330|NCT03681405|FG000|Participant Flow|Group I eHealth Mindful Movement and Breathing (eMMB)|"Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.~Informational Intervention: Given information about mindful movement and breathing~Questionnaire Administration: Ancillary studies"
10849380|NCT00296036|FG001|Participant Flow|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
10849381|NCT00296036|FG002|Participant Flow|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
10849382|NCT00296036|FG003|Participant Flow|Arm IV: (Placebo + Placebo)|Patients receive placebo cream and oral placebo.
10849383|NCT00296036|FG004|Participant Flow|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
10849384|NCT00296036|FG005|Participant Flow|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
10849385|NCT00296036|OG000|Outcome|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
10849386|NCT00296036|OG001|Outcome|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily.
10849387|NCT00296036|OG000|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
10879856|NCT00460421|BG000|Baseline|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
10879857|NCT00460421|BG001|Baseline|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
10879858|NCT00460421|BG002|Baseline|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
10879859|NCT00460421|BG003|Baseline|Total|Total of all reporting groups
10879860|NCT00460421|FG000|Participant Flow|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
10879861|NCT00460421|FG001|Participant Flow|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
10879862|NCT00460421|FG002|Participant Flow|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
11224957|NCT02364570|OG001|Outcome|Glucose With Whole Eggs|"We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 1.5 whole eggs (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.~Glucose (75g): Ingestion of glucose (75g)~Whole Eggs: Ingestion of 1.5 whole eggs"
11224958|NCT02364570|OG002|Outcome|Glucose With Egg Whites|"We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 7 egg whites (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.~Glucose (75g): Ingestion of glucose (75g)~Egg Whites: Ingestion of 7 egg whites"
11224959|NCT02364570|OG003|Outcome|Glucose With Egg Yolks|"We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 2 egg yolks (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.~Glucose (75g): Ingestion of glucose (75g)~Egg Yolks: Ingestion of 2 egg yolks"
11224960|NCT02364570|EG000|Reported Event|Oral Glucose Tolerance Test|"We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.~Glucose (100g): Ingestion of glucose (100g)"
11224961|NCT02364570|EG001|Reported Event|Glucose With Whole Eggs|"We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 1.5 whole eggs (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.~Glucose (75g): Ingestion of glucose (75g)~Whole Eggs: Ingestion of 1.5 whole eggs"
11224962|NCT02364570|EG002|Reported Event|Glucose With Egg Whites|"We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 7 egg whites (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.~Glucose (75g): Ingestion of glucose (75g)~Egg Whites: Ingestion of 7 egg whites"
11226863|NCT02378714|BG002|Baseline|Standard Treatment + Active Varenicline|"Standard behavioral smoking cessation treatment plus active varenicline~Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.~Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11341331|NCT03681405|FG001|Participant Flow|Group II Attention Control (AC)|"Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.~Questionnaire Administration: Ancillary studies~Telephone-Based Intervention: Receive caring attention phone call"
10849388|NCT00296036|OG001|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
10849389|NCT00296036|OG002|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
10849390|NCT00296036|OG003|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream and oral placebo.
10849391|NCT00296036|OG004|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
10879863|NCT00460421|OG000|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
11341332|NCT03681405|OG000|Outcome|Group I (eMMB)|"Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.~Informational Intervention: Given information about mindful movement and breathing~Questionnaire Administration: Ancillary studies"
10879864|NCT00460421|OG001|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
11348805|NCT04147442|OG000|Outcome|Music Program Fine-tuned|"The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings.~The participants performed the test with the fine-tuned music program."
10849392|NCT00296036|OG005|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
10849393|NCT00296036|OG002|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I.
10849394|NCT00296036|OG003|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream as in arm III and oral placebo as in arm II.
11145652|NCT01848353|EG004|Reported Event|Ramp-down Payment, Phase 3|"All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11342035|NCT03695367|OG001|Outcome|Cohort 2: HTX-011 + MMA Regimen + Ketorolac|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
11342036|NCT03695367|EG000|Reported Event|Cohort 1: HTX-011 + MMA Regimen|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
10849395|NCT00296036|OG001|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|"Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.~urea/lactic acid-based topical cream: Applied topically~placebo: Given orally or applied topically"
10849396|NCT00296036|OG002|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
10879865|NCT00460421|OG002|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
11335402|NCT03549598|OG000|Outcome|68Ga-DOTATATE PET/CT|"68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject~68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.~18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.~13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol."
10879866|NCT00460421|OG003|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
10879867|NCT00460421|EG000|Reported Event|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
10879868|NCT00460434|BG000|Baseline|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
10879869|NCT00460434|BG001|Baseline|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
10879870|NCT00460434|BG002|Baseline|Total|Total of all reporting groups
10879871|NCT00460434|FG000|Participant Flow|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
10879872|NCT00460434|FG001|Participant Flow|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
10879873|NCT00460434|OG000|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
10879874|NCT00460434|OG001|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
10879875|NCT00460434|EG000|Reported Event|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
10879876|NCT00460434|EG001|Reported Event|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
10879877|NCT00460525|BG000|Baseline|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
10879878|NCT00460525|BG001|Baseline|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
10879879|NCT00460525|BG002|Baseline|Total|Total of all reporting groups
10879880|NCT00460525|FG000|Participant Flow|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
10879881|NCT00460525|FG001|Participant Flow|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
10879882|NCT00460525|OG000|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
10879883|NCT00460525|OG001|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
10879884|NCT00460525|EG000|Reported Event|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
10879885|NCT00460525|EG001|Reported Event|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
10879886|NCT00460551|BG000|Baseline|Zalutumumab 8 mg/kg|
10879887|NCT00460551|FG000|Participant Flow|Zalutumumab 8 mg/kg|
10879888|NCT00460551|OG000|Outcome|Zalatumumab 8 mg/kg|
10879889|NCT00460551|EG000|Reported Event|Zalutumumab 8 mg/kg|
10879890|NCT00460564|BG000|Baseline|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
10879891|NCT00460564|BG001|Baseline|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
10879892|NCT00460564|BG002|Baseline|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
10879893|NCT00460564|BG003|Baseline|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
10879894|NCT00460564|BG004|Baseline|Total|Total of all reporting groups
10879895|NCT00460564|FG000|Participant Flow|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
10879896|NCT00460564|FG001|Participant Flow|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
10879897|NCT00460564|FG002|Participant Flow|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
10879898|NCT00460564|FG003|Participant Flow|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
11335403|NCT03549598|EG000|Reported Event|68Ga-DOTATATE PET/CT|"68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject~68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route."
11224963|NCT02364570|EG003|Reported Event|Glucose With Egg Yolks|"We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 2 egg yolks (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.~Glucose (75g): Ingestion of glucose (75g)~Egg Yolks: Ingestion of 2 egg yolks"
11224964|NCT02364700|BG000|Baseline|Interventional Group|This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks.
11224965|NCT02364700|FG000|Participant Flow|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
10879899|NCT00460564|FG004|Participant Flow|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
10879900|NCT00460564|FG005|Participant Flow|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
10879901|NCT00460564|FG006|Participant Flow|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
11224966|NCT02364700|OG000|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
11224967|NCT02364700|EG000|Reported Event|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
11224968|NCT02364778|BG000|Baseline|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
11224969|NCT02364778|BG001|Baseline|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
11224970|NCT02364778|BG002|Baseline|Total|Total of all reporting groups
11224971|NCT02364778|FG000|Participant Flow|Provisional Stenting Strategy|Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.
11224972|NCT02364778|OG000|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
11224973|NCT02364778|OG001|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
11224974|NCT02364778|EG000|Reported Event|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
11224975|NCT02364778|EG001|Reported Event|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
11224976|NCT02364947|BG000|Baseline|Nalmefene Hydrochloride 20 mg|Nalmefene hydrochloride: As-needed; tablets, orally
11224977|NCT02364947|BG001|Baseline|Nalmefene Hydrochloride 10 mg|Nalmefene hydrochloride: As-needed; tablets, orally
11224978|NCT02364947|BG002|Baseline|Placebo|Placebo: As-needed; tablets, orally
11224979|NCT02364947|BG003|Baseline|Total|Total of all reporting groups
11224980|NCT02364947|FG000|Participant Flow|Nalmefene Hydrochloride 20 mg|as-needed, tablets, orally, 24 weeks
11224981|NCT02364947|FG001|Participant Flow|Nalmefene Hydrochloride 10 mg|as-needed, tablets, orally, 24 weeks
11224982|NCT02364947|FG002|Participant Flow|Placebo|as-needed, tablets, orally, 24 weeks
11224983|NCT02364947|OG000|Outcome|Nalmefene Hydrochloride 20 mg|Nalmefene hydrochloride: As-needed; tablets, orally
11224984|NCT02364947|OG001|Outcome|Nalmefene Hydrochloride 10 mg|Nalmefene hydrochloride: As-needed; tablets, orally
11224985|NCT02364947|OG002|Outcome|Placebo|Placebo: As-needed; tablets, orally
11224986|NCT02364947|EG000|Reported Event|Nalmefene Hydrochloride 20 mg|Nalmefene hydrochloride: As-needed; tablets, orally
11224987|NCT02364947|EG001|Reported Event|Nalmefene Hydrochloride 10 mg|Nalmefene hydrochloride: As-needed; tablets, orally
11224988|NCT02364947|EG002|Reported Event|Placebo|Placebo: As-needed; tablets, orally
11226761|NCT02377817|FG000|Participant Flow|PrenaBelt on First Night, Sham PrenaBelt on Second Night|"These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night.~PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.~Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points."
11226762|NCT02377817|FG001|Participant Flow|Sham PrenaBelt on First Night, PrenaBelt on Second Night|"These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night.~PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.~Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points."
11226763|NCT02377817|OG000|Outcome|PrenaBelt Night|"On this night, the participants wore the PrenaBelt.~PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back."
11226764|NCT02377817|OG001|Outcome|Sham PrenaBelt Night|"On this night, the participants wore the sham PrenaBelt.~Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points."
11226765|NCT02377817|OG000|Outcome|Self-report|To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This data is per the participant's self-report, which was elicited from her via the PrenaBelt User Feedback Questionnaire immediately after waking in the morning. On the night previous, participants were not shown the questionnaire nor told specific details about questions she would be asked via the questionnaire in the morning.
11226766|NCT02377817|OG001|Outcome|Polysomnography|This data is per the participant's polysomnography recording.
11226767|NCT02377817|EG000|Reported Event|PrenaBelt on First Night, Sham PrenaBelt on Second Night|"These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night.~PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.~Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points."
11009496|NCT01102426|FG000|Participant Flow|Plitidepsin+Dexamethasone|"plitidepsin + dexamethasone combination~plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion."
11145653|NCT01848353|EG005|Reported Event|Raffle Payment, Phase 3|"All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.~Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors."
11145654|NCT01848353|EG006|Reported Event|Normal Weight, Low Activity Group|This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
11145655|NCT01848353|EG007|Reported Event|Normal Weight, High Activity Group|This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
11145656|NCT01848366|BG000|Baseline|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
11145657|NCT01848366|FG000|Participant Flow|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
11145658|NCT01848366|OG000|Outcome|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
11145659|NCT01848366|EG000|Reported Event|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
11145660|NCT01848457|BG000|Baseline|Arm 1|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 12-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145661|NCT01848457|BG001|Baseline|Arm 2|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145662|NCT01848457|BG002|Baseline|Arm 3|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 4-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145663|NCT01848457|BG003|Baseline|Arm 4|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145664|NCT01848457|BG004|Baseline|Total|Total of all reporting groups
11145665|NCT01848457|FG000|Participant Flow|Cycles 1 & 2: HDMTX 4h, PTZ+C; Then Cycles 3 & 4: HDTMX 12h, C|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 12-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145666|NCT01848457|FG001|Participant Flow|Cycles 1 & 2: HDMTX 4h, C; Then Cycles 3 & 4: HDTMX 12h, C+PTZ|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11149937|NCT01874392|BG000|Baseline|T1DM|"Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months~Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729~Artificial Pancreas (AP) device (APS©): Device includes:~OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp.~Dexcom® G4® CGM System (CGM) from Dexcom® Corp~Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)"
11149938|NCT01874392|FG000|Participant Flow|T1DM|"Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months~Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729~Artificial Pancreas (AP) device (APS©): Device includes:~OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp.~Dexcom® G4® CGM System (CGM) from Dexcom® Corp~Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)"
10849397|NCT00296036|OG003|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
10849398|NCT00296036|EG000|Reported Event|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
10849399|NCT00296036|EG001|Reported Event|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
11009497|NCT01102426|FG001|Participant Flow|Dexamethasone|"dexamethasone single agent~dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks."
11224989|NCT02364999|BG000|Baseline|PF-06439535|Participants received up to a maximum of 6 cycles of PF-06439535 (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by PF-06439535 monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin.
11224990|NCT02364999|BG001|Baseline|Bevacizumab-EU|Participants received up to a maximum of 6 cycles of Bevacizumab-EU (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by Bevacizumab-EU monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin.
11224991|NCT02364999|BG002|Baseline|Total|Total of all reporting groups
11224992|NCT02364999|FG000|Participant Flow|PF-06439535|Participants received up to a maximum of 6 cycles of PF-06439535 (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by PF-06439535 monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin.
11224993|NCT02364999|FG001|Participant Flow|Bevacizumab-EU|Participants received up to a maximum of 6 cycles of Bevacizumab-EU (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by Bevacizumab-EU monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin.
11335404|NCT03549598|EG001|Reported Event|18FDG PET/CT|"68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject~18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol."
10879902|NCT00460564|FG007|Participant Flow|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
10879903|NCT00460564|OG000|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
10879904|NCT00460564|OG001|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
11224994|NCT02364999|OG000|Outcome|PF-06439535|Participants received up to a maximum of 6 cycles of PF-06439535 (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by PF-06439535 monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin.
11335405|NCT03549598|EG002|Reported Event|"13NH3 PET/CT"|"68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject~13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol."
11335406|NCT03550066|BG000|Baseline|Values Affirmation|A health message with a prompt asking participants to reflect on important personal values
11145667|NCT01848457|FG002|Participant Flow|Cycles 1 & 2: HDMTX 12h, PTZ+C; Then Cycles 3 & 4: HDTMX 4h, C|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 4-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145668|NCT01848457|FG003|Participant Flow|Cycles 1 & 2: HDMTX 12h, C; Then Cycles 3 & 4: HDTMX 4h, C+PTZ|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145669|NCT01848457|OG000|Outcome|Treatments Arms 1 & 3 (Groups With PTZ in Cycles 1 & 2)|Arm 1 receives a 4-hour infusion of HDTX, and Arm 3 receives a 12-hour infusion of HDTMX, during Cycles 1 & 2. Both arms also receive C and PTZ during Cycles 1 & 2.
10849400|NCT00296140|BG000|Baseline|Self Management of PSD Symptoms|Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.
11145670|NCT01848457|OG001|Outcome|Treatments Arms 2 & 4 (Groups Without PTZ in Cycles 1 & 2)|Am 2 receives a 4-hour infusion of HDTMX, and Arm 4 receives a 12-hour infusion of HDTMX during Cycles 1 & 2. Both arms also receive the C doses, but without PTZ.
11335407|NCT03550066|BG001|Baseline|No Affirmation|A health message presented alone, with no values affirmation
11335408|NCT03550066|BG002|Baseline|Total|Total of all reporting groups
11335409|NCT03550066|FG000|Participant Flow|Values Affirmation|Values affirmation: A health message with a prompt asking participants to reflect on important personal values
11335410|NCT03550066|FG001|Participant Flow|No Affirmation|No affirmation: A health message alone
10879905|NCT00460564|OG000|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
11335411|NCT03550066|OG000|Outcome|Values Affirmation|Values affirmation: A health message with a prompt asking participants to reflect on important personal values
10879906|NCT00460564|OG001|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
11335412|NCT03550066|OG001|Outcome|No Affirmation|No affirmation: A health message alone
11335413|NCT03550066|EG000|Reported Event|Values Affirmation|Values affirmation: A health message with a prompt asking participants to reflect on important personal values
11335414|NCT03550066|EG001|Reported Event|No Affirmation|No affirmation: A health message alone
10879907|NCT00460564|OG002|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
11335415|NCT03550209|BG000|Baseline|LCPUFA Oil Supplement, Low Dose|"25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11145671|NCT01848457|OG000|Outcome|Localized Disease at Baseline|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 12-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145672|NCT01848457|OG001|Outcome|Metastatic Disease at Baseline|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 4-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145673|NCT01848457|OG000|Outcome|Treatment Arms 1, 3 (w/ Pantoprazole)|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145674|NCT01848457|OG001|Outcome|Treatment Arms 2, 4 (w/o Pantoprazole)|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145675|NCT01848457|OG000|Outcome|Arm 1|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 12-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145676|NCT01848457|OG001|Outcome|Arm 2|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145677|NCT01848457|OG002|Outcome|Arm 3|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 4-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145678|NCT01848457|OG003|Outcome|Arm 4|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145679|NCT01848457|OG000|Outcome|Individual Subjects|
11145680|NCT01848457|OG000|Outcome|All Study Participants (Arms 1-4)|All participants in the study, regardless of which arm or order they were randomized to receive the study treatment.
11145681|NCT01848457|EG000|Reported Event|Arm 1|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 12-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145682|NCT01848457|EG001|Reported Event|Arm 2|"Cycles 1 and 2: HDMTX administered as a 4-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11335416|NCT03550209|BG001|Baseline|LCPUFA Oil Supplement, Medium Dose|"50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11342037|NCT03695367|EG001|Reported Event|Cohort 2: HTX-011 + MMA Regimen + Ketorolac|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
11335417|NCT03550209|BG002|Baseline|LCPUFA Oil Supplement, High Dose|"75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
10879908|NCT00460564|OG003|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
11224995|NCT02364999|OG001|Outcome|Bevacizumab-EU|Participants received up to a maximum of 6 cycles of Bevacizumab-EU (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by Bevacizumab-EU monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin.
10879909|NCT00460564|OG000|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
11224996|NCT02364999|EG000|Reported Event|PF-06439535|Participants received up to a maximum of 6 cycles of PF-06439535 (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by PF-06439535 monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin.
10879910|NCT00460564|OG001|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
11335418|NCT03550209|BG003|Baseline|Canola Oil|"Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days~Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days"
11335419|NCT03550209|BG004|Baseline|Total|Total of all reporting groups
11342058|NCT03696108|EG000|Reported Event|Gefapixant 15 mg|Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks
11145683|NCT01848457|EG002|Reported Event|Arm 3|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 4-hour infusion and cisplatin is administered alone~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
10879911|NCT00460564|OG002|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
11145684|NCT01848457|EG003|Reported Event|Arm 4|"Cycles 1 and 2: HDMTX administered as a 12-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin~Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)~High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours"
11145685|NCT01848483|BG000|Baseline|AIDS EPC Package Plus MI|AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
11145686|NCT01848483|BG001|Baseline|Standard of Care (SOC)|Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
11145687|NCT01848483|BG002|Baseline|Total|Total of all reporting groups
11145688|NCT01848483|FG000|Participant Flow|AIDS EPC Package Plus MI|AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
11145689|NCT01848483|FG001|Participant Flow|Standard of Care (SOC)|"Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment~Standard of Care (SOC): The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts ART, an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects."
11145690|NCT01848483|OG000|Outcome|AIDS EPC Package Plus MI|AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
11145691|NCT01848483|OG001|Outcome|Standard of Care (SOC)|Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
11145692|NCT01848483|OG001|Outcome|Standard of Care (SOC)|"Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment~Standard of Care (SOC): The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts ART, an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects."
11145693|NCT01848483|EG000|Reported Event|AIDS EPC Package Plus MI|AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
11145694|NCT01848483|EG001|Reported Event|Standard of Care (SOC)|"Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment~Standard of Care (SOC): The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts ART, an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects."
11145695|NCT01848756|BG000|Baseline|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
11335420|NCT03550209|FG000|Participant Flow|LCPUFA Oil Supplement, Low Dose|"25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11145696|NCT01848756|FG000|Participant Flow|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
11145697|NCT01848756|OG000|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
11145698|NCT01848756|OG000|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
10879912|NCT00460564|OG003|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
10879913|NCT00460564|EG000|Reported Event|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
11145699|NCT01848756|EG000|Reported Event|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
11145700|NCT01848821|BG000|Baseline|OASIS Half of Wound|"OASIS will be applied to one half of the wound and standard of care consisting of wound vac only will be applied to the other half.~OASIS Ultra: Porcine derived intestinal submucosa"
11145701|NCT01848821|BG001|Baseline|Standard Therapy Half of Wound|"Standard therapy to half of wound will consistent of non-stick mesh and wound VAC application.~Wound VAC Standard Therapy: Negative pressure wound device aka wound VAC will be placed on the standard therapy half of the wound"
11145702|NCT01848821|BG002|Baseline|Total|Total of all reporting groups
10879914|NCT00460564|EG001|Reported Event|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
11145703|NCT01848821|FG000|Participant Flow|OASIS|"OASIS Ultra (Porcine derived intestinal submucosa) to half of the wound.~Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the OASIS half of the wound."
11145704|NCT01848821|FG001|Participant Flow|Standard Therapy|"Standard therapy to half of wound will consistent of non-adherent dressing and overlying VAC application.~Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the standard therapy half of the wound."
11145705|NCT01848821|OG000|Outcome|OASIS|"OASIS Ultra (Porcine derived intestinal submucosa) to half of the wound.~Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the OASIS half of the wound."
11342059|NCT03696108|EG001|Reported Event|Gefapixant 45 mg|Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
11145706|NCT01848821|OG001|Outcome|Standard Therapy|"Standard therapy to half of wound will consistent of non-adherent dressing and overlying VAC application.~Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the standard therapy half of the wound."
11145707|NCT01848821|EG000|Reported Event|OASIS|"OASIS Ultra (Porcine derived intestinal submucosa) to half of the wound.~Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the OASIS half of the wound."
11145708|NCT01848821|EG001|Reported Event|Standard Therapy|"Standard therapy to half of wound will consistent of non-adherent dressing and overlying VAC application.~Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the standard therapy half of the wound."
11145709|NCT01848834|BG000|Baseline|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145710|NCT01848834|BG001|Baseline|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145711|NCT01848834|BG002|Baseline|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11335421|NCT03550209|FG001|Participant Flow|LCPUFA Oil Supplement, Medium Dose|"50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11145712|NCT01848834|BG003|Baseline|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145713|NCT01848834|BG004|Baseline|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145714|NCT01848834|BG005|Baseline|Total|Total of all reporting groups
11145715|NCT01848834|FG000|Participant Flow|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145716|NCT01848834|FG001|Participant Flow|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145717|NCT01848834|FG002|Participant Flow|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145718|NCT01848834|FG003|Participant Flow|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145719|NCT01848834|FG004|Participant Flow|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145720|NCT01848834|OG000|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145721|NCT01848834|OG001|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145722|NCT01848834|OG002|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145723|NCT01848834|OG003|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11335422|NCT03550209|FG002|Participant Flow|LCPUFA Oil Supplement, High Dose|"75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11145724|NCT01848834|OG004|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145725|NCT01848834|OG000|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145726|NCT01848834|OG000|Outcome|Cohorts B & B2: Head & Neck Cancer HPV-Positive Participants|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks or pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145727|NCT01848834|OG000|Outcome|Cohort D: Gastric Cancer AP Participants|Participants who were from the Asia Pacific region received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145728|NCT01848834|OG000|Outcome|Cohorts B & B2: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks (Cohort B) or pembrolizumab, 200 mg, IV once every 3 weeks (Cohort B2), and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145729|NCT01848834|EG000|Reported Event|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145730|NCT01848834|EG001|Reported Event|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145731|NCT01848834|EG002|Reported Event|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
10879915|NCT00460564|EG002|Reported Event|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
11145732|NCT01848834|EG003|Reported Event|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145733|NCT01848834|EG004|Reported Event|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
11145734|NCT01848847|BG000|Baseline|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
11145735|NCT01848847|BG001|Baseline|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
11145736|NCT01848847|BG002|Baseline|Total|Total of all reporting groups
11145737|NCT01848847|FG000|Participant Flow|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
11145738|NCT01848847|FG001|Participant Flow|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
11145739|NCT01848847|OG000|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
11145740|NCT01848847|OG001|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
11145741|NCT01848847|EG000|Reported Event|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
11145742|NCT01848847|EG001|Reported Event|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
11145743|NCT01848899|BG000|Baseline|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
11145744|NCT01848899|BG001|Baseline|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
11145745|NCT01848899|BG002|Baseline|Total|Total of all reporting groups
11145746|NCT01848899|FG000|Participant Flow|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
11145747|NCT01848899|FG001|Participant Flow|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
11145748|NCT01848899|OG000|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
11145749|NCT01848899|OG001|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
11145750|NCT01848899|EG000|Reported Event|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
10879916|NCT00460564|EG003|Reported Event|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
10879917|NCT00460564|EG004|Reported Event|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
11145751|NCT01848899|EG001|Reported Event|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
11145752|NCT01848938|BG000|Baseline|Smartphone Treatment|"Smartphone treatment with pelvic floor muscle training (PFMT).~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
11145753|NCT01848938|BG001|Baseline|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
11145754|NCT01848938|BG002|Baseline|Total|Total of all reporting groups
11145755|NCT01848938|FG000|Participant Flow|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
11145756|NCT01848938|FG001|Participant Flow|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
11145757|NCT01848938|OG000|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
11145758|NCT01848938|OG001|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
11145759|NCT01848938|EG000|Reported Event|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
11145760|NCT01848938|EG001|Reported Event|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
11009498|NCT01102426|OG000|Outcome|Plitidepsin+Dexamethasone|"plitidepsin + dexamethasone combination~plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion."
11009499|NCT01102426|OG001|Outcome|Dexamethasone|"dexamethasone single agent~dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks."
11335423|NCT03550209|FG003|Participant Flow|Canola Oil|"Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days~Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days"
11145761|NCT01848977|BG000|Baseline|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
11145762|NCT01848977|FG000|Participant Flow|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
11145763|NCT01848977|OG000|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to InSpectra™ .
11145764|NCT01848977|OG001|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to INVOS®.
11145765|NCT01848977|OG000|Outcome|INVOS®|Basline value before VOT,and minimum/ maximum values of INVOS® were obtained and compared to InSpectra™ .
11145766|NCT01848977|OG001|Outcome|InSpectra™|Basline value before VOT,and minimum/ maximum values of InSpectra™ were obtained and compared to INVOS®.
11145767|NCT01848977|OG000|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Reactive hyperemic area were calculated and compared to InSpectra™ .
11145768|NCT01848977|OG001|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Reactive hyperemic area were calculated and compared to INVOS®.
11145769|NCT01848977|EG000|Reported Event|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
11145770|NCT01848990|BG000|Baseline|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 12 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 12-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11335424|NCT03550209|OG000|Outcome|LCPUFA Oil Supplement, Low Dose|"25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11009500|NCT01102426|EG000|Reported Event|Plitidepsin+Dexamethasone|"plitidepsin + dexamethasone combination~plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion."
11009501|NCT01102426|EG001|Reported Event|Dexamethasone|"dexamethasone single agent~dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks."
11009502|NCT01102491|BG000|Baseline|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
11009503|NCT01102491|BG001|Baseline|Control|no antiemetic prophylaxis
11009504|NCT01102491|BG002|Baseline|Total|Total of all reporting groups
11009505|NCT01102491|FG000|Participant Flow|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
11009506|NCT01102491|FG001|Participant Flow|Control|no antiemetic prophylaxis
11145771|NCT01848990|BG001|Baseline|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 12 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 12-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11145772|NCT01848990|BG002|Baseline|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 12 months.
11145773|NCT01848990|BG003|Baseline|Total|Total of all reporting groups
11348806|NCT04147442|OG001|Outcome|Music Program Standard|"The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings.~The participants performed the test with the standard default music program."
11348807|NCT04147442|OG002|Outcome|Unaided|The participants performed the test with no hearing aids.
10849401|NCT00296140|BG001|Baseline|Screening and Treatment of PSD|Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
10849402|NCT00296140|BG002|Baseline|Total|Total of all reporting groups
10849403|NCT00296140|FG000|Participant Flow|Self Management of PSD Symptoms|Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.
10849404|NCT00296140|FG001|Participant Flow|Screening and Treatment of PSD|Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
11009507|NCT01102491|OG000|Outcome|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
11009508|NCT01102491|OG001|Outcome|Control|no antiemetic prophylaxis
11335425|NCT03550209|OG001|Outcome|LCPUFA Oil Supplement, Medium Dose|"50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11145774|NCT01848990|FG000|Participant Flow|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 12 months, participants received their regular treatment of rapid-acting continuous subcutaneous insulin infusion (CSII) (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 12-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11335426|NCT03550209|OG002|Outcome|LCPUFA Oil Supplement, High Dose|"75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11009509|NCT01102491|EG000|Reported Event|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
11145775|NCT01848990|FG001|Participant Flow|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 12 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 12-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11145776|NCT01848990|FG002|Participant Flow|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 12 months.
11145777|NCT01848990|OG000|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting Continuous Subcutaneous Insulin Infusion (CSII) (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11145778|NCT01848990|OG001|Outcome|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
11009510|NCT01102491|EG001|Reported Event|Control|no antiemetic prophylaxis
11145779|NCT01848990|OG000|Outcome|Hylenex Recombinant|For 12 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 12-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11145780|NCT01848990|OG001|Outcome|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 12 months.
11145781|NCT01848990|OG000|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11145782|NCT01848990|OG001|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
11145783|NCT01848990|OG001|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 12 months.
11009511|NCT01102738|BG000|Baseline|Premature Babies (<32 Weeks)|All premature babies born at less than 32 completed weeks gestation who are admitted to an Imperial College NHS Healthcare Trust Neonatal Intensive Care Unit (St. Mary's Hospital or Queen Charlotte's & Chelsea Hospital), and whose parents/guardians have given their consent will be eligible to enter the study.
11145784|NCT01848990|EG000|Reported Event|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 12 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 12-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11145785|NCT01848990|EG001|Reported Event|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 12 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 12-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
11145786|NCT01848990|EG002|Reported Event|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 12 months.
11145787|NCT01849055|BG000|Baseline|Placebo|Placebo administered PO, QD, for 28 days
11145788|NCT01849055|BG001|Baseline|2.5 mg LY3023703|2.5 mg LY3023703 administered PO, QD, for 28 days
11145789|NCT01849055|BG002|Baseline|7.5 mg LY3023703|7.5 mg LY3023703 administered PO, QD, for 28 days
11145790|NCT01849055|BG003|Baseline|15 mg LY3023703|15 mg LY3023703 administered PO, QD, for 28 days
11145791|NCT01849055|BG004|Baseline|30 mg LY3023703|30 mg LY3023703 administered PO, QD, for 28 days
11145792|NCT01849055|BG005|Baseline|400 mg Celecoxib|400 mg celecoxib administered PO, QD, for 28 days
11145793|NCT01849055|BG006|Baseline|Total|Total of all reporting groups
11145794|NCT01849055|FG000|Participant Flow|Placebo|Placebo administered by mouth (PO), once a day (QD), for 28 days
11145795|NCT01849055|FG001|Participant Flow|2.5 mg LY3023703|2.5 milligram (mg) LY3023703 administered PO, QD, for 28 days
11145796|NCT01849055|FG002|Participant Flow|7.5 mg LY3023703|7.5 mg LY3023703 administered PO, QD, for 28 days
11145797|NCT01849055|FG003|Participant Flow|15 mg LY3023703|15 mg LY3023703 administered PO, QD, for 28 days
11145798|NCT01849055|FG004|Participant Flow|30 mg LY3023703|30 mg LY3023703 administered PO, QD, for 28 days
11145799|NCT01849055|FG005|Participant Flow|400 mg Celecoxib|400 mg celecoxib administered PO, QD, for 28 days
11145800|NCT01849055|OG000|Outcome|Placebo|Placebo administered PO, QD, for 28 days
11145801|NCT01849055|OG001|Outcome|2.5 mg LY3023703|2.5 mg LY3023703 administered PO, QD, for 28 days
11009512|NCT01102738|FG000|Participant Flow|Premature Babies (<32 Weeks)|All premature babies born at less than 32 completed weeks gestation who are admitted to an Imperial College NHS Healthcare Trust Neonatal Intensive Care Unit (St. Mary's Hospital or Queen Charlotte's & Chelsea Hospital), and whose parents/guardians have given their consent will be eligible to enter the study.
11145802|NCT01849055|OG002|Outcome|7.5 mg LY3023703|7.5 mg LY3023703 administered PO, QD, for 28 days
10879918|NCT00460564|EG005|Reported Event|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
11009513|NCT01102738|OG000|Outcome|Premature Babies (<32 Weeks)|All premature babies born at less than 32 completed weeks gestation who are admitted to an Imperial College NHS Healthcare Trust Neonatal Intensive Care Unit (St. Mary's Hospital or Queen Charlotte's & Chelsea Hospital), and whose parents/guardians have given their consent will be eligible to enter the study.
11145803|NCT01849055|OG003|Outcome|15 mg LY3023703|15 mg LY3023703 administered PO, QD, for 28 days
11145804|NCT01849055|OG004|Outcome|30 mg LY3023703|30 mg LY3023703 administered PO, QD, for 28 days
11145805|NCT01849055|OG005|Outcome|400 mg Celecoxib|400 mg celecoxib administered PO, QD, for 28 days
11145806|NCT01849055|OG000|Outcome|2.5 mg LY3023703|2.5 mg LY3023703 administered PO, QD, for 28 days
11145807|NCT01849055|OG001|Outcome|7.5 mg LY3023703|7.5 mg LY3023703 administered PO, QD, for 28 days
11145808|NCT01849055|OG002|Outcome|15 mg LY3023703|15 mg LY3023703 administered PO, QD, for 28 days
11145809|NCT01849055|OG003|Outcome|30 mg LY3023703|30 mg LY3023703 administered PO, QD, for 28 days
11145810|NCT01849055|EG000|Reported Event|Placebo|Placebo administered PO, QD, for 28 days
11145811|NCT01849055|EG001|Reported Event|2.5 mg LY3023703|2.5 mg LY3023703 administered PO, QD, for 28 days
11145812|NCT01849055|EG002|Reported Event|7.5 mg LY3023703|7.5 mg LY3023703 administered PO, QD, for 28 days
11145813|NCT01849055|EG003|Reported Event|15 mg LY3023703|15 mg LY3023703 administered PO, QD, for 28 days
11145814|NCT01849055|EG004|Reported Event|30 mg LY3023703|30 mg LY3023703 administered PO, QD, for 28 days
11145815|NCT01849055|EG005|Reported Event|400 mg Celecoxib|400 mg celecoxib administered PO, QD, for 28 days
11145816|NCT01849068|BG000|Baseline|Ezetimibe First Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo 12 weeks
11145817|NCT01849068|BG001|Baseline|Placebo First Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 12 weeks
11145818|NCT01849068|BG002|Baseline|Total|Total of all reporting groups
11145819|NCT01849068|FG000|Participant Flow|Ezetimibe First, Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo for 12 weeks
11145820|NCT01849068|FG001|Participant Flow|Placebo First, Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 10 mg/d for 12 weeks
11145821|NCT01849068|OG000|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
11145822|NCT01849068|OG001|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
11145823|NCT01849068|EG000|Reported Event|Ezetimibe|Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
11145824|NCT01849068|EG001|Reported Event|Placebo|Placebo for 12 weeks Placebo for 12 weeks
11149939|NCT01874392|OG000|Outcome|T1DM|"Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months~Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729~Artificial Pancreas (AP) device (APS©): Device includes:~OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp.~Dexcom® G4® CGM System (CGM) from Dexcom® Corp~Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)"
11149940|NCT01874392|EG000|Reported Event|T1DM|"Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months~Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729~Artificial Pancreas (AP) device (APS©): Device includes:~OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp.~Dexcom® G4® CGM System (CGM) from Dexcom® Corp~Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)"
11149941|NCT01874431|BG000|Baseline|Finerenone (BAY94-8862) (1.25 mg)|1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
11149942|NCT01874431|BG001|Baseline|Finerenone (BAY94-8862) (2.5 mg)|2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149943|NCT01874431|BG002|Baseline|Finerenone (BAY94-8862) (5 mg)|5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149944|NCT01874431|BG003|Baseline|Finerenone (BAY94-8862) (7.5 mg)|7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149945|NCT01874431|BG004|Baseline|Finerenone (BAY94-8862) (10 mg)|10 mg BAY94-8862 tablet once daily in the morning for 90 days.
11066006|NCT01390818|BG003|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066007|NCT01390818|BG004|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
10879919|NCT00460564|EG006|Reported Event|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
11066008|NCT01390818|BG005|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11149946|NCT01874431|BG005|Baseline|Finerenone (BAY94-8862) (15 mg)|15 mg BAY94-8862 tablet once daily in the morning for 90 days.
11145825|NCT01849172|BG000|Baseline|Acupuncture|"Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.~acupuncture: Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all)."
11149947|NCT01874431|BG006|Baseline|Finerenone (BAY94-8862) (20 mg)|20 mg BAY94-8862 tablet once daily in the morning for 90 days
11149948|NCT01874431|BG007|Baseline|Placebo|Placebo tablet once daily in the morning for 90 days.
11149949|NCT01874431|BG008|Baseline|Total|Total of all reporting groups
11149950|NCT01874431|FG000|Participant Flow|Finerenone (BAY94-8862) (1.25 mg)|1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
11149951|NCT01874431|FG001|Participant Flow|Finerenone (BAY94-8862) (2.5 mg)|2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149952|NCT01874431|FG002|Participant Flow|Finerenone (BAY94-8862) (5 mg)|5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149953|NCT01874431|FG003|Participant Flow|Finerenone (BAY94-8862) (7.5 mg)|7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149954|NCT01874431|FG004|Participant Flow|Finerenone (BAY94-8862) (10 mg)|10 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149955|NCT01874431|FG005|Participant Flow|Finerenone (BAY94-8862) (15 mg)|15 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149956|NCT01874431|FG006|Participant Flow|Finerenone (BAY94-8862) (20 mg)|20 mg BAY94-8862 tablet once daily in the morning for 90 days
11149957|NCT01874431|FG007|Participant Flow|Placebo|Placebo tablet once daily in the morning for 90 days.
11149958|NCT01874431|OG000|Outcome|Finerenone (BAY94-8862) (1.25 mg)|1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
11149959|NCT01874431|OG001|Outcome|Finerenone (BAY94-8862) (2.5 mg)|2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149960|NCT01874431|OG002|Outcome|Finerenone (BAY94-8862) (5 mg)|5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149961|NCT01874431|OG003|Outcome|Finerenone (BAY94-8862) (7.5 mg)|7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149962|NCT01874431|OG004|Outcome|Finerenone (BAY94-8862) (10 mg)|10 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149963|NCT01874431|OG005|Outcome|Finerenone (BAY94-8862) (15 mg)|15 mg BAY94-8862 tablet once daily in the morning for 90 days.
11149964|NCT01874431|OG006|Outcome|Finerenone (BAY94-8862) (20 mg)|20 mg BAY94-8862 tablet once daily in the morning for 90 days
11149965|NCT01874431|OG007|Outcome|Placebo|Placebo tablet once daily in the morning for 90 days.
11149966|NCT01874431|EG000|Reported Event|Finerenone (BAY94-8862) (1.25 mg)|1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days
11149967|NCT01874431|EG001|Reported Event|Finerenone (BAY94-8862)(2.5 mg)|2.5 mg BAY94-8862 tablet once daily in the morning for 90 days
11149968|NCT01874431|EG002|Reported Event|Finerenone (BAY94-8862)(5 mg)|5 mg BAY94-8862 tablet once daily in the morning for 90 days
11149969|NCT01874431|EG003|Reported Event|Finerenone (BAY94-8862)(7.5 mg)|7.5 mg BAY94-8862 tablet once daily in the morning for 90 days
11149970|NCT01874431|EG004|Reported Event|Finerenone (BAY94-8862)(10 mg)|10 mg BAY94-8862 tablet once daily in the morning for 90 days
11149971|NCT01874431|EG005|Reported Event|Finerenone (BAY94-8862)(15 mg)|15 mg BAY94-8862 tablet once daily in the morning for 90 days
11149972|NCT01874431|EG006|Reported Event|Finerenone (BAY94-8862)(20 mg)|20 mg BAY94-8862 tablet once daily in the morning for 90 days
11145826|NCT01849172|BG001|Baseline|Sham Acupuncture|"Electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.~sham acupuncture: Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6).Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actual"
11145827|NCT01849172|BG002|Baseline|Total|Total of all reporting groups
11145828|NCT01849172|FG000|Participant Flow|Acupuncture|"Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.~acupuncture: Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all)."
11149973|NCT01874431|EG007|Reported Event|Placebo|Placebo tablet once daily in the morning for 90 days
11149974|NCT01874535|BG000|Baseline|4-week Group|"Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily~Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis"
11145829|NCT01849172|FG001|Participant Flow|Sham Acupuncture|"Electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).~One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.~sham acupuncture: Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6).~Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actu"
11145830|NCT01849172|OG000|Outcome|Electroacupuncture|Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.
11145831|NCT01849172|OG001|Outcome|Sham Electroacupuncture|Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
11149975|NCT01874535|BG001|Baseline|8-week Group|"Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily~Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis"
11149976|NCT01874535|BG002|Baseline|Total|Total of all reporting groups
11149977|NCT01874535|FG000|Participant Flow|4-week Group|"Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily~Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis"
11335427|NCT03550209|OG003|Outcome|Canola Oil|"Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days~Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days"
11224997|NCT02364999|EG001|Reported Event|Bevacizumab-EU|Participants received up to a maximum of 6 cycles of Bevacizumab-EU (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by Bevacizumab-EU monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin.
11224998|NCT02364999|EG002|Reported Event|Total|This reporting group include all participants who received at least 1 dose of study treatment from PF-06439535 and Bevacizumab-EU groups.
11224999|NCT02365064|BG000|Baseline|Continuous Positive Airway Pressure|"Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.~AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes."
11225000|NCT02365064|BG001|Baseline|Adaptive Servo-Ventilation|"Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.~AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes."
11225001|NCT02365064|BG002|Baseline|Total|Total of all reporting groups
11225002|NCT02365064|FG000|Participant Flow|Continuous Positive Airway Pressure|"Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.~AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes."
11225003|NCT02365064|FG001|Participant Flow|Adaptive Servo-Ventilation|"Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.~AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes."
11225004|NCT02365064|OG000|Outcome|Continuous Positive Airway Pressure|"Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.~AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes."
11225005|NCT02365064|OG001|Outcome|Adaptive Servo-Ventilation|"Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.~AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes."
11225006|NCT02365064|EG000|Reported Event|Continuous Positive Airway Pressure|Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
11225007|NCT02365064|EG001|Reported Event|Adaptive Servo-Ventilation|Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
11225008|NCT02365285|BG000|Baseline|Galantamine 16 mg Then Placebo (African-American)|"Galantamine 16 mg po one time dose then placebo on 2nd visit~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225009|NCT02365285|BG001|Baseline|Galantamine 16 mg Then Placebo (White)|"Galantamine 16 mg po one time dose then placebo on 2nd visit~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11149978|NCT01874535|FG001|Participant Flow|8-week Group|"Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily~Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis"
11149979|NCT01874535|OG000|Outcome|4 Week Group|"Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily~Esomeprazole 40 mg: Comparison of 4-weeks weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis"
11145832|NCT01849172|EG000|Reported Event|Acupuncture|"Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.~acupuncture: Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all)."
11145833|NCT01849172|EG001|Reported Event|Sham Acupuncture|"Electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.sham acupuncture: Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6).~Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actually."
11145834|NCT01849276|BG000|Baseline|Treatment (Enzyme Inhibitor and Chemotherapy)|"Patients receive metformin hydrochloride orally twice a day on days 1-15 and cytarabine IV over 3 hours twice on days 4-10.~metformin hydrochloride: Given orally~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11145835|NCT01849276|FG000|Participant Flow|Treatment (Enzyme Inhibitor and Chemotherapy)|"Patients receive metformin hydrochloride orally twice a day on days 1-15 and cytarabine IV over 3 hours twice on days 4-10.~metformin hydrochloride: Given orally~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11145836|NCT01849276|OG000|Outcome|Treatment (Enzyme Inhibitor and Chemotherapy)|"Patients receive metformin hydrochloride orally twice a day on days 1-15 and cytarabine IV over 3 hours twice on days 4-10.~metformin hydrochloride: Given orally~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11145837|NCT01849276|EG000|Reported Event|Treatment (Enzyme Inhibitor and Chemotherapy)|"Patients receive metformin hydrochloride orally twice a day on days 1-15 and cytarabine IV over 3 hours twice on days 4-10.~metformin hydrochloride: Given orally~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11145838|NCT01849289|BG000|Baseline|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
11145839|NCT01849289|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
11145840|NCT01849289|BG002|Baseline|Total|Total of all reporting groups
11145841|NCT01849289|FG000|Participant Flow|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
11145842|NCT01849289|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
11145843|NCT01849289|OG000|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
11145844|NCT01849289|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
11149980|NCT01874535|OG001|Outcome|8 Week Group|"Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily~Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis"
11145845|NCT01849289|EG000|Reported Event|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
11225010|NCT02365285|BG002|Baseline|Placebo Then Galantamine 16 mg (African-American)|"Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225011|NCT02365285|BG003|Baseline|Placebo Then Galantamine 16 mg (White)|"Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225012|NCT02365285|BG004|Baseline|Total|Total of all reporting groups
11225013|NCT02365285|FG000|Participant Flow|Galantamine 16 mg Then Placebo (African-American)|"Galantamine 16 mg po one time dose then placebo on 2nd visit~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225014|NCT02365285|FG001|Participant Flow|Galantamine 16 mg Then Placebo (White)|"Galantamine 16 mg po one time dose then placebo on 2nd visit~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225015|NCT02365285|FG002|Participant Flow|Placebo Then Galantamine 16 mg (African-American)|"Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225016|NCT02365285|FG003|Participant Flow|Placebo Then Galantamine 16 mg (White)|"Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225017|NCT02365285|OG000|Outcome|Galantamine 16 mg (African-American)|"Galantamine 16 mg po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225018|NCT02365285|OG001|Outcome|Galantamine 16 mg (White)|"Galantamine 16 mg po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225019|NCT02365285|OG002|Outcome|Placebo (African-American)|"Placebo capsule po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225020|NCT02365285|OG003|Outcome|Placebo (White)|"Placebo capsule po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225021|NCT02365285|OG001|Outcome|Galantamine 16 mg(White)|"Galantamine 16 mg po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225022|NCT02365285|OG003|Outcome|Placebo(White)|"Placebo capsule po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225023|NCT02365285|EG000|Reported Event|Galantamine 16 mg (African-American)|"Galantamine 16 mg po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225024|NCT02365285|EG001|Reported Event|Galantamine 16 mg (White)|"Galantamine 16 mg po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225025|NCT02365285|EG002|Reported Event|Placebo (African-American)|"Placebo capsule po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225026|NCT02365285|EG003|Reported Event|Placebo (White)|"Placebo capsule po one time dose~Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine~Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine"
11225027|NCT02365298|BG000|Baseline|All Dispensed Subjects|All subjects that were dispensed a study lens.
11225028|NCT02365298|FG000|Participant Flow|Etafilcon a /Nelfilcon A|Subjects that were randomized to receive the etafilcon A lens first, and then to receive the nelfilcon A lens second.
11225029|NCT02365298|FG001|Participant Flow|Nelfilcon A / Etafilcon A|Subjects that were randomized to receive the nelfilcon A lens first, and then to receive the etafilcon A lens second.
11225030|NCT02365298|OG000|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
11225031|NCT02365298|OG001|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
11225032|NCT02365298|EG000|Reported Event|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
11225033|NCT02365298|EG001|Reported Event|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
11225034|NCT02365480|BG000|Baseline|Arm I (Berberine Chloride)|"Patients receive berberine chloride PO TID for 90 days in the absence of disease progression or unacceptable toxicity.~Berberine Chloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11225035|NCT02365480|BG001|Baseline|Arm II (Placebo)|"Participants receive placebo PO TID for 90 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO"
11225036|NCT02365480|BG002|Baseline|Total|Total of all reporting groups
11225037|NCT02365480|FG000|Participant Flow|Arm I (Berberine Chloride)|"Patients receive berberine chloride PO TID for 90 days in the absence of disease progression or unacceptable toxicity.~Berberine Chloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11225038|NCT02365480|FG001|Participant Flow|Arm II (Placebo)|"Participants receive placebo PO TID for 90 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO"
11225039|NCT02365480|OG000|Outcome|Arm I (Berberine Chloride)|"Patients receive berberine chloride PO TID for 90 days in the absence of disease progression or unacceptable toxicity.~Berberine Chloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11225040|NCT02365480|OG001|Outcome|Arm II (Placebo)|"Participants receive placebo PO TID for 90 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO"
11225041|NCT02365480|EG000|Reported Event|Arm I (Berberine Chloride)|"Patients receive berberine chloride PO TID for 90 days in the absence of disease progression or unacceptable toxicity.~Berberine Chloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11225042|NCT02365480|EG001|Reported Event|Arm II (Placebo)|"Participants receive placebo PO TID for 90 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO"
11225043|NCT02365506|BG000|Baseline|Eleclazine 24 mg + Eleclazine 48 mg + Placebo|Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
11225044|NCT02365506|BG001|Baseline|Eleclazine 48 mg + Placebo|Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
11225045|NCT02365506|BG002|Baseline|Placebo|Participants received placebo to match eleclazine tablets on Days 1 to 4.
11225046|NCT02365506|BG003|Baseline|Total|Total of all reporting groups
11225047|NCT02365506|FG000|Participant Flow|Eleclazine 24 mg + Eleclazine 48 mg + Placebo|Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
11225048|NCT02365506|FG001|Participant Flow|Eleclazine 48 mg + Placebo|Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
11225049|NCT02365506|FG002|Participant Flow|Placebo|Participants received placebo to match eleclazine tablets on Days 1 to 4.
11145846|NCT01849289|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
11145847|NCT01849419|BG000|Baseline|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).~Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).~Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
11145848|NCT01849419|FG000|Participant Flow|Single Group|"Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.~This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo over the course of four experimental sessions. Drug order was randomized for each participant."
11145849|NCT01849419|OG000|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
11145850|NCT01849419|OG000|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
11149981|NCT01874535|EG000|Reported Event|4 Week Group|"Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily~Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis"
11225050|NCT02365506|OG000|Outcome|Eleclazine 24 mg + Eleclazine 48 mg + Placebo|Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
11225051|NCT02365506|OG001|Outcome|Eleclazine 48 mg + Placebo|Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
11225052|NCT02365506|OG002|Outcome|Placebo|Participants received placebo to match eleclazine tablets on Days 1 to 4.
11225053|NCT02365506|EG000|Reported Event|Eleclazine 24 mg + Eleclazine 48 mg + Placebo|Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
11225054|NCT02365506|EG001|Reported Event|Eleclazine 48 mg + Placebo|Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3.
11225055|NCT02365506|EG002|Reported Event|Placebo|Participants received placebo to match eleclazine tablets on Days 1 to 4.
11225056|NCT02365519|BG000|Baseline|LME636|All subjects randomized and treated with LME636 ophthalmic solution
11225057|NCT02365519|BG001|Baseline|Vehicle|All subjects randomized and treated with LME636 Vehicle
11225058|NCT02365519|BG002|Baseline|Total|Total of all reporting groups
11225059|NCT02365519|FG000|Participant Flow|Vehicle Run-In|All subjects exposed to LME636 Vehicle prior to the initiation of randomized study treatment
11225060|NCT02365519|FG001|Participant Flow|LME636|All subjects exposed to LME636 ophthalmic solution during randomized study treatment
11225061|NCT02365519|FG002|Participant Flow|Vehicle|All subjects exposed to LME636 Vehicle during randomized study treatment
11225062|NCT02365519|OG000|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
11225063|NCT02365519|OG001|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
11225064|NCT02365519|OG001|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks during randomized study treatment
11225065|NCT02365519|OG002|Outcome|Run-In Only|LME636 Vehicle, 1 drop administered topically in each eye TID for 4 weeks with exit prior to start of randomized treatment
11225066|NCT02365519|EG000|Reported Event|Vehicle Run-In|All subjects exposed to LME636 Vehicle prior to the initiation of randomized study treatment
11225067|NCT02365519|EG001|Reported Event|LME636|All subjects exposed to LME636 ophthalmic solution during randomized study treatment
11225068|NCT02365519|EG002|Reported Event|Vehicle|All subjects exposed to LME636 Vehicle during randomized study treatment
11225069|NCT02365558|BG000|Baseline|Overall Study|Single oral dose of 130 mg evacetrapib on Day 1 and oral doses of 40 mg omeprazole QD on Days 8 through 20, with a single oral dose of 130 mg evacetrapib coadministered on Day 14
11225070|NCT02365558|FG000|Participant Flow|Evacetrapib|Evacetrapib 130 milligram (mg) administered as a single oral dose on Day 1.
11225071|NCT02365558|FG001|Participant Flow|Evacetrapib + Omeprazole|Omeprazole 40 mg administered once daily (QD) orally on Day 8 through 20. Evacetrapib 130mg coadministered as a single oral dose on Day 14.
11225072|NCT02365558|OG000|Outcome|Evacetrapib|Single oral dose of Evacetrapib administered on Day 1 of Period 1
11225073|NCT02365558|OG001|Outcome|Evacetrapib + Omeprazole|"In Period 2, Participants will receive 40 mg oral dose of Omeprazole QD on Days 8 through 20.~Evacetrapib will be coadministered once, orally on Day 14."
11225074|NCT02365558|OG000|Outcome|Evacetrapib|Single oral dose of evacetrapib administered alone on Day 1 of Period 1.
11225075|NCT02365558|OG001|Outcome|Evacetrapib + Omeprazole|"In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20.~Evacetrapib will be co-administered once, orally on Day 14."
11225076|NCT02365558|EG000|Reported Event|Evacetrapib|"Single oral dose of Evacetrapib administered alone on Day 1 of Period 1.~Evacetrapib: Administered orally"
11225077|NCT02365558|EG001|Reported Event|Evacetrapib + Omeprazole|"In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20.~Evacetrapib will be coadministered once, orally on Day 14.~Evacetrapib: Administered orally~Omeprazole: Administered orally"
11225078|NCT02365558|EG002|Reported Event|Evacetrapib + Omeprazole Follow-up|Evacetrapib + Omeprazole Follow-up will occur at least 14 days after last dose of Evacetrapib on Day 14.
11225079|NCT02365584|BG000|Baseline|Standard Care|Patients received standard care only according to site clinical practice.
11225080|NCT02365584|BG001|Baseline|Standard Care + Lanreotide Autogel|Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
11225081|NCT02365584|BG002|Baseline|Total Title|
11225082|NCT02365584|FG000|Participant Flow|Standard Care|Patients received standard care only according to site clinical practice.
11225083|NCT02365584|FG001|Participant Flow|Standard Care + Lanreotide Autogel|Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 milligrams (mg) by deep subcutaneous injection on Day 1.
11225084|NCT02365584|OG000|Outcome|Standard Care|Patients received standard care only according to site clinical practice.
11145851|NCT01849419|EG000|Reported Event|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).~Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).~Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
11145852|NCT01849458|BG000|Baseline|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
11145853|NCT01849458|FG000|Participant Flow|BioFiber Scaffold|Single arm of subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
11145854|NCT01849458|OG000|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
11145855|NCT01849458|EG000|Reported Event|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
11145856|NCT01849497|BG000|Baseline|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
11145857|NCT01849497|BG001|Baseline|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
11145858|NCT01849497|BG002|Baseline|Total|Total of all reporting groups
11145859|NCT01849497|FG000|Participant Flow|Evolocumab PFS|"Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).~Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4."
11145860|NCT01849497|FG001|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
11145861|NCT01849497|OG000|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
11145862|NCT01849497|OG001|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
11145863|NCT01849497|EG000|Reported Event|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
11145864|NCT01849497|EG001|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
11145865|NCT01849562|BG000|Baseline|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11145866|NCT01849562|BG001|Baseline|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11145867|NCT01849562|BG002|Baseline|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
11145868|NCT01849562|BG003|Baseline|Total|Total of all reporting groups
11145869|NCT01849562|FG000|Participant Flow|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11145870|NCT01849562|FG001|Participant Flow|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11145871|NCT01849562|FG002|Participant Flow|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
11145872|NCT01849562|OG000|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11145873|NCT01849562|OG001|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11145874|NCT01849562|OG002|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
11145875|NCT01849562|OG001|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-2000mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11145876|NCT01849562|EG000|Reported Event|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11348808|NCT04147442|EG000|Reported Event|Music Program Fine-tuned|"The fine-tuned program and the standard program will be compared within the same instrument as a hearing aid can have up to 4 different listening programs in it.~Hearing aid with fine-tuned program: A digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fine-tuned for their specific music playing."
11348809|NCT04147455|BG000|Baseline|Health Education Control Condition|Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.
11348810|NCT04147455|BG001|Baseline|RealConsent|Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants viewed six 30-minute modules designed to prevent sexual violence in young men.
11348811|NCT04147455|BG002|Baseline|Total|Total of all reporting groups
11348812|NCT04147455|FG000|Participant Flow|Health Education Control Condition|Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.
11348813|NCT04147455|FG001|Participant Flow|RealConsent|Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants viewed six 30-minute modules designed to prevent sexual violence in young men.
11348814|NCT04147455|OG000|Outcome|Health Education Control Condition|Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.
11348815|NCT04147455|OG001|Outcome|RealConsent|Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants viewed six 30-minute modules designed to prevent sexual violence in young men.
11348816|NCT04147455|EG000|Reported Event|Health Education Control Condition|Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.
11348817|NCT04147455|EG001|Reported Event|RealConsent|Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants viewed six 30-minute modules designed to prevent sexual violence in young men.
11348818|NCT04146272|BG000|Baseline|Current Mermaid First, Then New|Participants were randomized to wear the current hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new Hearing aid for another 10 days.
11009514|NCT01102738|EG000|Reported Event|Premature Babies (<32 Weeks)|"All premature babies born at less than 32 completed weeks gestation who are admitted to an Imperial College NHS Healthcare Trust Neonatal Intensive Care Unit (St. Mary's Hospital or Queen Charlotte's & Chelsea Hospital), and whose parents/guardians have given their consent will be eligible to enter the study.~No adverse events related to the study occurred. The study was an observational study which only involved the collection of clinical data, faecal samples, urine samples and skin swabs."
11009515|NCT01102764|BG000|Baseline|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
11348819|NCT04146272|BG001|Baseline|New Mermaid First, Then Current|Participants were randomized to wear the new Hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current Hearing aid for another 10 days.
11348820|NCT04146272|BG002|Baseline|Current Power First, Then New|Participants were randomized to wear the current power hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new power Hearing aid for another 10 days.
11348821|NCT04146272|BG003|Baseline|New Power First, Then Current|Participants were randomized to wear the new power hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current power Hearing aid for another 10 days.
11348822|NCT04146272|BG004|Baseline|Total|Total of all reporting groups
11348823|NCT04146272|FG000|Participant Flow|Moderate Hearing Loss Current Mermaid, Then New|Participants first used the current Mermaid hearing aid with the current feedback cancellation system for 10 days. Then they used the new Mermaid Hearing aid with the new feedback system for 10 days.
11348824|NCT04146272|FG001|Participant Flow|Moderate Hearing Loss New Mermaid, Then Current|Participants first used the new Mermaid hearing aid with the new feedback cancellation system for 10 days. Then they used the current Mermaid Hearing aid with the current feedback system for 10 days.
11348825|NCT04146272|FG002|Participant Flow|Severe Hearing Loss Current Power, Then New|Participants first used the current power hearing aid with the current feedback cancellation system for 10 days. Then they used the new power Hearing aid with the new feedback system for 10 days.
11348826|NCT04146272|FG003|Participant Flow|Severe Hearing Loss New Power First/Current Second|The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
11348827|NCT04146272|OG000|Outcome|Moderate Hearing Loss Current Mermaid First/New Second|The current Mermaid hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first for this group. The new Hearing aid with the new feedback system will be used second.
11348828|NCT04146272|OG001|Outcome|Moderate Hearing Loss New Mermaid First/Current Second|The new Mermaid Hearing aid with the new feedback system will be worn first for this group.The current hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
11348829|NCT04146272|OG002|Outcome|Severe Hearing Loss Current Power First/New Second|The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first by this group. The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn second.
11145877|NCT01849562|EG001|Reported Event|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
11145878|NCT01849562|EG002|Reported Event|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
11225085|NCT02365584|OG001|Outcome|Standard Care + Lanreotide Autogel|Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
11009516|NCT01102764|BG001|Baseline|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
11009517|NCT01102764|BG002|Baseline|Total|Total of all reporting groups
11225086|NCT02365584|EG000|Reported Event|Standard Care|Patients received standard care only according to site clinical practice.
11145879|NCT01849575|BG000|Baseline|Intervention|"Intervention: Pictorial information about carotid ultrasound results to the participant and his/her primary care physician. Asymptomatic atherosclerosis presented as vascular age with a gauge going from green (biological age 10 years younger than chronological age), over yellow, orange to red (10 years older). Plaque formation shown as a traffic light with a green dot (no plaque) or red dot (plaque) for each side. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months.~CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period."
11145880|NCT01849575|BG001|Baseline|Control|The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
11145881|NCT01849575|BG002|Baseline|Total|Total of all reporting groups
11145882|NCT01849575|FG000|Participant Flow|Intervention|"Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician. Carotid intima-media thickness was presented as vascular age illustrating the individual's biological compared to chronological age, with a gauge going from green (at least 10 years younger), to yellow, orange or red (at least 10 years older). Plaque formation was a traffic light (green - no plaque, red - plaque). General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months.~CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period."
11145883|NCT01849575|FG001|Participant Flow|Control|The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
11149982|NCT01874535|EG001|Reported Event|8 Week Group|"Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily~Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis"
11225087|NCT02365584|EG001|Reported Event|Standard Care + Lanreotide Autogel|Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
11225088|NCT02365636|BG000|Baseline|TV-45070 4%|TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11145884|NCT01849575|OG000|Outcome|Intervention|"The intervention: Giving communication about risk of cardiovascular disease in the form of written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness, highlighted as vascular age, and plaque formation, visualized as a traffic light (green - no plaque, red - plaque).The ultrasound results are given to the study person and his/her physician, in addition to information about conventional risk factors for cardiovascular disease~Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months.~CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period."
11145885|NCT01849575|OG001|Outcome|Control|The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors
11145886|NCT01849575|OG000|Outcome|Intervention|"Intervention: Pictorial information about carotid ultrasound results to the participant and his/her primary care physician. Asymptomatic atherosclerosis presented as vascular age with a gauge going from green (biological age 10 years younger than chronological age), over yellow, orange to red (10 years older). Plaque formation shown as a traffic light with a green dot (no plaque) or red dot (plaque) for each side. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months.~CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period."
11145887|NCT01849575|OG001|Outcome|Control|The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
11145888|NCT01849575|EG000|Reported Event|Intervention|"Intervention: Pictorial information about carotid ultrasound results to the participant and his/her primary care physician. Asymptomatic atherosclerosis presented as vascular age with a gauge going from green (biological age 10 years younger than chronological age), over yellow, orange to red (10 years older). Plaque formation shown as a traffic light with a green dot (no plaque) or red dot (plaque) for each side. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months.~CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period."
11145889|NCT01849575|EG001|Reported Event|Control|The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
11145890|NCT01849588|BG000|Baseline|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
11145891|NCT01849588|FG000|Participant Flow|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
11145892|NCT01849588|OG000|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
11145893|NCT01849588|EG000|Reported Event|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
11145894|NCT01849692|BG000|Baseline|ESBA|All subjects who were treated with ESBA1008.
11145895|NCT01849692|BG001|Baseline|LUCENTIS|All subjects who were treated with LUCENTIS.
11145896|NCT01849692|BG002|Baseline|Total|Total of all reporting groups
11145897|NCT01849692|FG000|Participant Flow|Cohort 1 - ESBA|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg)
11145898|NCT01849692|FG001|Participant Flow|Cohort 1 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
11145899|NCT01849692|FG002|Participant Flow|Cohort 2 - ESBA|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg)
11145900|NCT01849692|FG003|Participant Flow|Cohort 2 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
11145901|NCT01849692|FG004|Participant Flow|Cohort 3 - ESBA|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg)
11145902|NCT01849692|FG005|Participant Flow|Cohort 3 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
11145903|NCT01849692|FG006|Participant Flow|Cohort 4 - ESBA|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg)
11145904|NCT01849692|FG007|Participant Flow|Cohort 4 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
11145905|NCT01849692|OG000|Outcome|Cohort 1|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
11145906|NCT01849692|OG001|Outcome|Cohort 2|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
11145907|NCT01849692|OG002|Outcome|Cohort 3|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
11145908|NCT01849692|OG003|Outcome|Cohort 4|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
11145909|NCT01849692|OG000|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA 1008 1.2 mg IVT injection
11145910|NCT01849692|OG001|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
11145911|NCT01849692|OG000|Outcome|ESBA 1 mg INF|All subjects treated with ESBA 1008 1 mg IVT infusion
11145912|NCT01849692|OG000|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA 1008 0.6 mg IVT injection
11145913|NCT01849692|OG000|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
11145914|NCT01849692|OG000|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg IVT injection
11145915|NCT01849692|OG000|Outcome|ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg IVT infusion
11145916|NCT01849692|OG000|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg IVT injection
11145917|NCT01849692|EG000|Reported Event|Stage 1 ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg via injection
11145918|NCT01849692|EG001|Reported Event|Stage 1 ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg via infusion
10879920|NCT00460564|EG007|Reported Event|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
11225089|NCT02365636|BG001|Baseline|TV-45070 8%|TV-45070 ointment in a 8% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
10879921|NCT00460577|BG000|Baseline|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
11225090|NCT02365636|BG002|Baseline|Placebo|Placebo ointment applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
10879922|NCT00460577|BG001|Baseline|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
11225091|NCT02365636|BG003|Baseline|Total|Total of all reporting groups
11225092|NCT02365636|FG000|Participant Flow|TV-45070 4%|TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
10879923|NCT00460577|BG002|Baseline|Total|Total of all reporting groups
11225093|NCT02365636|FG001|Participant Flow|TV-45070 8%|TV-45070 ointment in a 8% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11009518|NCT01102764|FG000|Participant Flow|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
11009519|NCT01102764|FG001|Participant Flow|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
11009520|NCT01102764|OG000|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
11009521|NCT01102764|OG001|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
11348830|NCT04146272|OG003|Outcome|Severe Hearing Loss New Power First/Current Second|The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
10879924|NCT00460577|FG000|Participant Flow|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
10879925|NCT00460577|FG001|Participant Flow|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
11009522|NCT01102764|EG000|Reported Event|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
11009523|NCT01102764|EG001|Reported Event|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
11009524|NCT01102777|BG000|Baseline|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
11009525|NCT01102777|BG001|Baseline|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
11009526|NCT01102777|BG002|Baseline|Total|Total of all reporting groups
11009527|NCT01102777|FG000|Participant Flow|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
11009528|NCT01102777|FG001|Participant Flow|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
11009529|NCT01102777|OG000|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
11145919|NCT01849692|EG002|Reported Event|Stage 1 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 1
11145920|NCT01849692|EG003|Reported Event|Stage 2 ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg via injection
11145921|NCT01849692|EG004|Reported Event|Stage 2 ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg via infusion
11145922|NCT01849692|EG005|Reported Event|Stage 2 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 2
11145923|NCT01849692|EG006|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11145924|NCT01849770|BG000|Baseline|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
11145925|NCT01849770|BG001|Baseline|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
11145926|NCT01849770|BG002|Baseline|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
11145927|NCT01849770|BG003|Baseline|Total|Total of all reporting groups
11145928|NCT01849770|FG000|Participant Flow|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
11145929|NCT01849770|FG001|Participant Flow|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
11145930|NCT01849770|FG002|Participant Flow|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
10879926|NCT00460577|OG000|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
11145931|NCT01849770|OG000|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
11145932|NCT01849770|OG001|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
11145933|NCT01849770|OG002|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
11145934|NCT01849770|OG000|Outcome|300mg vs Placebo|
11145935|NCT01849770|OG001|Outcome|900mg vs Placebo|
11145936|NCT01849770|EG000|Reported Event|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
11145937|NCT01849770|EG001|Reported Event|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
11145938|NCT01849770|EG002|Reported Event|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
11145939|NCT01849822|BG000|Baseline|Neural Prosthetic System|The Neural Prosthetic System consists of two Neuroport Arrays. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
11145940|NCT01849822|FG000|Participant Flow|Neural Prosthetic System|The Neural Prosthetic System consists of two Neuroport Arrays. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
11145941|NCT01849822|OG000|Outcome|Neural Prosthetic System|The Neural Prosthetic System consists of two Neuroport Arrays. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
11145942|NCT01849822|EG000|Reported Event|Neural Prosthetic System|The Neural Prosthetic System consists of two Neuroport Arrays. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
11145943|NCT01849848|BG000|Baseline|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
11145944|NCT01849848|FG000|Participant Flow|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
11145945|NCT01849848|OG000|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
11149983|NCT01874665|BG000|Baseline|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
11149984|NCT01874665|BG001|Baseline|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
11145946|NCT01849848|EG000|Reported Event|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
11145947|NCT01850030|BG000|Baseline|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
11145948|NCT01850030|BG001|Baseline|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
11145949|NCT01850030|BG002|Baseline|Total|Total of all reporting groups
11145950|NCT01850030|FG000|Participant Flow|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
11145951|NCT01850030|FG001|Participant Flow|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
11145952|NCT01850030|OG000|Outcome|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
11145953|NCT01850030|OG001|Outcome|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
11145954|NCT01850030|EG000|Reported Event|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
11145955|NCT01850030|EG001|Reported Event|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
11145956|NCT01850394|BG000|Baseline|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
11145957|NCT01850394|BG001|Baseline|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
11066009|NCT01390818|BG006|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11145958|NCT01850394|BG002|Baseline|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
10879927|NCT00460577|OG001|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
11145959|NCT01850394|BG003|Baseline|Total|Total of all reporting groups
11145960|NCT01850394|FG000|Participant Flow|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
11145961|NCT01850394|FG001|Participant Flow|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
11145962|NCT01850394|FG002|Participant Flow|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
10879928|NCT00460577|EG000|Reported Event|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
11145963|NCT01850394|OG000|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
11145964|NCT01850394|OG001|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
11145965|NCT01850394|OG002|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
11145966|NCT01850394|EG000|Reported Event|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
11145967|NCT01850394|EG001|Reported Event|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
11145968|NCT01850394|EG002|Reported Event|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
11145969|NCT01850446|BG000|Baseline|Ergoferon (1 Tablet 3 Times a Day)|"Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.~Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day."
11145970|NCT01850446|BG001|Baseline|Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day|"Oseltamivir: The treatment period is 5 days.~1 capsule (75 mg) twice a day during the meal or regardless of meal."
11145971|NCT01850446|BG002|Baseline|Total|Total of all reporting groups
11145972|NCT01850446|FG000|Participant Flow|Ergoferon (1 Tablet 3 Times a Day)|"Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.~Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day."
11145973|NCT01850446|FG001|Participant Flow|Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day|"Oseltamivir: The treatment period is 5 days.~1 capsule (75 mg) twice a day during the meal or regardless of meal."
11149985|NCT01874665|BG002|Baseline|Total|Total of all reporting groups
11149986|NCT01874665|FG000|Participant Flow|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 milligram (mg), taken orally once-daily.
11009530|NCT01102777|OG001|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
11145974|NCT01850446|OG000|Outcome|Ergoferon (1 Tablet 3 Times a Day)|"Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.~Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day."
11145975|NCT01850446|OG001|Outcome|Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day|"Oseltamivir: The treatment period is 5 days.~1 capsule (75 mg) twice a day during the meal or regardless of meal."
11149987|NCT01874665|FG001|Participant Flow|Cohort B|Participants with gastrointestinal stromal tumors (GIST) that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
11149988|NCT01874665|OG000|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
11145976|NCT01850446|EG000|Reported Event|Ergoferon (1 Tablet 3 Times a Day)|"Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.~Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day."
11145977|NCT01850446|EG001|Reported Event|Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day|"Oseltamivir: The treatment period is 5 days.~1 capsule (75 mg) twice a day during the meal or regardless of meal."
11145978|NCT01850485|BG000|Baseline|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
11145979|NCT01850485|BG001|Baseline|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
11145980|NCT01850485|BG002|Baseline|Total|Total of all reporting groups
11145981|NCT01850485|FG000|Participant Flow|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
11145982|NCT01850485|FG001|Participant Flow|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
11145983|NCT01850485|OG000|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
11145984|NCT01850485|OG001|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
11145985|NCT01850485|EG000|Reported Event|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
11145986|NCT01850485|EG001|Reported Event|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
11145987|NCT01850550|BG000|Baseline|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
11145988|NCT01850550|BG001|Baseline|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
11145989|NCT01850550|BG002|Baseline|Total|Total of all reporting groups
11145990|NCT01850550|FG000|Participant Flow|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
11145991|NCT01850550|FG001|Participant Flow|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
11145992|NCT01850550|OG000|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
11145993|NCT01850550|OG001|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
11145994|NCT01850550|EG000|Reported Event|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
11145995|NCT01850550|EG001|Reported Event|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
11145996|NCT01850589|BG000|Baseline|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
11149989|NCT01874665|OG000|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
11149990|NCT01874665|OG001|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
11149991|NCT01874665|EG000|Reported Event|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
11149992|NCT01874665|EG001|Reported Event|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
11145997|NCT01850589|BG001|Baseline|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
11145998|NCT01850589|BG002|Baseline|Total|Total of all reporting groups
11145999|NCT01850589|FG000|Participant Flow|Conserative Therapy|"Patients will be counseled by the vascular attending/fellow during their office appointment to stop smoking. Counseling will consist of a self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
11146000|NCT01850589|FG001|Participant Flow|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~8 one hour group counseling sessions focusing on patient education and behavior modification.~Behavior modifications include cue recognition; coping skills; stress management; and relapse prevention skills.~Counseling includes information on nutrition, exercise, and chemical dependency.~All counseling sessions will be held at 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer~Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
11146001|NCT01850589|OG000|Outcome|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
11146002|NCT01850589|OG001|Outcome|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
11146003|NCT01850589|EG000|Reported Event|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
11146004|NCT01850589|EG001|Reported Event|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
11146005|NCT01850602|BG000|Baseline|PA21|PA21
11146006|NCT01850602|BG001|Baseline|Sevelamer Hydrochloride|Sevelamer hydrochloride
11146007|NCT01850602|BG002|Baseline|Total|Total of all reporting groups
11146008|NCT01850602|FG000|Participant Flow|PA21|PA21
11146009|NCT01850602|FG001|Participant Flow|Sevelamer Hydrochloride|Sevelamer hydrochloride
11146010|NCT01850602|OG000|Outcome|PA21|PA21
10879929|NCT00460577|EG001|Reported Event|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
11146011|NCT01850602|OG001|Outcome|Sevelamer Hydrochloride|Sevelamer hydrochloride
11146012|NCT01850602|EG000|Reported Event|PA21|PA21
11146013|NCT01850602|EG001|Reported Event|Sevelamer Hydrochloride|Sevelamer hydrochloride
11146014|NCT01850615|BG000|Baseline|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
11146015|NCT01850615|BG001|Baseline|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
11146016|NCT01850615|BG002|Baseline|Total|Total of all reporting groups
11146017|NCT01850615|FG000|Participant Flow|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different plasma glucose (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given once daily (OD), in the evening, at approximately the same time each day.
11146018|NCT01850615|FG001|Participant Flow|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
11146019|NCT01850615|OG000|Outcome|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
11146020|NCT01850615|OG001|Outcome|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
11149993|NCT01874756|BG000|Baseline|Placebo|"placebo 6 pills of inactive drug~Placebo: 6 placebo capsules daily for 8 weeks"
11149994|NCT01874756|BG001|Baseline|LY500307 25mg|"LY500307 25mg~LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks"
11146021|NCT01850615|EG000|Reported Event|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
11146022|NCT01850615|EG001|Reported Event|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
11146023|NCT01850641|BG000|Baseline|PA21|PA21
11146024|NCT01850641|FG000|Participant Flow|PA21|PA21
11146025|NCT01850641|OG000|Outcome|PA21|PA21
11146026|NCT01850641|EG000|Reported Event|PA21|PA21
11146027|NCT01850745|BG000|Baseline|Control|Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
11146028|NCT01850745|BG001|Baseline|Validation Cohort|"Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.~Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed."
11146029|NCT01850745|BG002|Baseline|Pilot Cohort|"Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.~Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed."
11146030|NCT01850745|BG003|Baseline|Total|Total of all reporting groups
11146031|NCT01850745|FG000|Participant Flow|Control|Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
11146032|NCT01850745|FG001|Participant Flow|Validation Cohort|"Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.~Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed."
11146033|NCT01850745|FG002|Participant Flow|Pilot Cohort|"Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.~Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed."
11146034|NCT01850745|OG000|Outcome|Control|Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
11146035|NCT01850745|OG001|Outcome|Validation Cohort|"Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.~Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed."
11146036|NCT01850745|OG002|Outcome|Pilot Cohort|"Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.~Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed."
11146037|NCT01850745|EG000|Reported Event|Control|Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
11146038|NCT01850745|EG001|Reported Event|Validation Cohort|"Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.~Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed."
11146039|NCT01850745|EG002|Reported Event|Pilot Cohort|"Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.~Multidisciplinary support program: Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed."
11146040|NCT01850823|BG000|Baseline|Placebo|Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils
11146041|NCT01850823|BG001|Baseline|NASONEX® Nasal Spray (Schering Corporation)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146042|NCT01850823|BG002|Baseline|Mometasone Nasal Spray (Watson Laboratories, Inc)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146043|NCT01850823|BG003|Baseline|Total|Total of all reporting groups
11146044|NCT01850823|FG000|Participant Flow|Placebo|Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils
11146045|NCT01850823|FG001|Participant Flow|NASONEX® Nasal Spray (Schering Corporation)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146046|NCT01850823|FG002|Participant Flow|Mometasone Nasal Spray (Watson Laboratories, Inc)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146047|NCT01850823|OG000|Outcome|NASONEX® Nasal Spray (Schering Corporation)|Mometasone Nasal spray, 50 mcg per acuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146048|NCT01850823|OG001|Outcome|Mometasone Nasal Spray (Watson Laboratories, Inc)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146049|NCT01850823|OG000|Outcome|Placebo|Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils
11146050|NCT01850823|OG001|Outcome|NASONEX® Nasal Spray (Schering Corporation)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146051|NCT01850823|OG002|Outcome|Mometasone Nasal Spray (Watson Laboratories, Inc)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146052|NCT01850823|EG000|Reported Event|Placebo|Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils
11146053|NCT01850823|EG001|Reported Event|NASONEX® Nasal Spray (Schering Corporation)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146054|NCT01850823|EG002|Reported Event|Mometasone Nasal Spray (Watson Laboratories, Inc)|Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
11146055|NCT01851330|BG000|Baseline|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
11146056|NCT01851330|BG001|Baseline|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
11146057|NCT01851330|BG002|Baseline|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
11146058|NCT01851330|BG003|Baseline|Total|Total of all reporting groups
11146059|NCT01851330|FG000|Participant Flow|LDV/SOF 8 Week|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks
11146060|NCT01851330|FG001|Participant Flow|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
11146061|NCT01851330|FG002|Participant Flow|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
11146062|NCT01851330|OG000|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
11146063|NCT01851330|OG001|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
11146064|NCT01851330|OG002|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
11146065|NCT01851330|EG000|Reported Event|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
11146066|NCT01851330|EG001|Reported Event|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
11146067|NCT01851330|EG002|Reported Event|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
11146068|NCT01851590|BG000|Baseline|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)~Resin Lacquer is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
11146069|NCT01851590|BG001|Baseline|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine Lacquer is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
11146070|NCT01851590|BG002|Baseline|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
11146071|NCT01851590|BG003|Baseline|Total|Total of all reporting groups
11146072|NCT01851590|FG000|Participant Flow|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)~Resin Lacquer was administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
11146073|NCT01851590|FG001|Participant Flow|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine: Amorolfine was administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
11146074|NCT01851590|FG002|Participant Flow|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine: Terbinafine 250 mg was administered orally once a day for 3 months in toenail onychomycosis."
11146075|NCT01851590|OG000|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % Resin Lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
11146076|NCT01851590|OG001|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
11146077|NCT01851590|OG002|Outcome|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
11146078|NCT01851590|OG000|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
11146079|NCT01851590|OG001|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
11146080|NCT01851590|OG002|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
11146081|NCT01851590|OG001|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
11146082|NCT01851590|EG000|Reported Event|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
11146083|NCT01851590|EG001|Reported Event|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
11146084|NCT01851590|EG002|Reported Event|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
11146085|NCT01851655|BG000|Baseline|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
11146086|NCT01851655|BG001|Baseline|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
11146087|NCT01851655|BG002|Baseline|Total|Total of all reporting groups
11146088|NCT01851655|FG000|Participant Flow|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
11146089|NCT01851655|FG001|Participant Flow|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
11146090|NCT01851655|OG000|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
11146091|NCT01851655|OG001|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
11146092|NCT01851655|EG000|Reported Event|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
11146093|NCT01851655|EG001|Reported Event|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
11146094|NCT01851720|BG000|Baseline|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
11146095|NCT01851720|BG001|Baseline|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
11146096|NCT01851720|BG002|Baseline|Total|Total of all reporting groups
11146097|NCT01851720|FG000|Participant Flow|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
11146098|NCT01851720|FG001|Participant Flow|Low Dose IV Fentanyl Patient Controlled Analgesia (PCA)|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
11146099|NCT01851720|OG000|Outcome|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
11146100|NCT01851720|OG001|Outcome|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
11146101|NCT01851720|EG000|Reported Event|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
11146102|NCT01851720|EG001|Reported Event|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
11146103|NCT01851772|BG000|Baseline|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
11146104|NCT01851772|FG000|Participant Flow|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
11146105|NCT01851772|OG000|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
11146106|NCT01851772|EG000|Reported Event|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
11146107|NCT01851863|BG000|Baseline|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
11146108|NCT01851863|BG001|Baseline|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
11146109|NCT01851863|BG002|Baseline|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
11146110|NCT01851863|BG003|Baseline|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
11146111|NCT01851863|BG004|Baseline|Total|Total of all reporting groups
11146112|NCT01851863|FG000|Participant Flow|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
11146113|NCT01851863|FG001|Participant Flow|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
11146114|NCT01851863|FG002|Participant Flow|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
11146115|NCT01851863|FG003|Participant Flow|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
11146116|NCT01851863|OG000|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
11146117|NCT01851863|OG001|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
11146118|NCT01851863|OG002|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
11146119|NCT01851863|OG000|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole) .The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
11146120|NCT01851863|OG001|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
11146121|NCT01851863|OG003|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
11146122|NCT01851863|OG000|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
11146123|NCT01851863|EG000|Reported Event|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
11146124|NCT01851863|EG001|Reported Event|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
11146125|NCT01851863|EG002|Reported Event|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
11146126|NCT01851863|EG003|Reported Event|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
11146127|NCT01851876|BG000|Baseline|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
11146128|NCT01851876|BG001|Baseline|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
11146129|NCT01851876|BG002|Baseline|Total|Total of all reporting groups
11146130|NCT01851876|FG000|Participant Flow|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
11146131|NCT01851876|FG001|Participant Flow|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
11146132|NCT01851876|OG000|Outcome|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
11146133|NCT01851876|OG001|Outcome|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
11146134|NCT01851876|EG000|Reported Event|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
11146135|NCT01851876|EG001|Reported Event|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
11146136|NCT01852019|BG000|Baseline|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146137|NCT01852019|BG001|Baseline|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146138|NCT01852019|BG002|Baseline|Total|Total of all reporting groups
11146139|NCT01852019|FG000|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion|"Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146140|NCT01852019|FG001|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11149995|NCT01874756|BG002|Baseline|LY500307 75mg|"LY500307 75mg~LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks"
11149996|NCT01874756|BG003|Baseline|LY500307 150mg|"LY500307 150mg~LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks"
11149997|NCT01874756|BG004|Baseline|Total|Total of all reporting groups
11146141|NCT01852019|FG002|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146142|NCT01852019|FG003|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146143|NCT01852019|FG004|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146144|NCT01852019|OG000|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11149998|NCT01874756|FG000|Participant Flow|Placebo|"placebo 6 pills of inactive drug~Placebo: 6 placebo capsules daily for 8 weeks"
11149999|NCT01874756|FG001|Participant Flow|LY500307 25mg|"LY500307 25mg~LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks"
11150000|NCT01874756|FG002|Participant Flow|LY500307 75mg|"LY500307 75mg~LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks"
11150001|NCT01874756|FG003|Participant Flow|LY500307 150mg|"LY500307 150mg~LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks"
11150002|NCT01874756|OG000|Outcome|LY500307 150mg|"LY500307 150mg~LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks"
11150003|NCT01874756|OG001|Outcome|Placebo|"placebo 6 pills of inactive drug~Placebo: 6 placebo capsules daily for 8 weeks"
11150004|NCT01874756|OG002|Outcome|LY500307 75mg|"LY500307 75mg~LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks"
11150005|NCT01874756|OG003|Outcome|LY500307 25mg|"LY500307 25mg~LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks"
11150006|NCT01874756|EG000|Reported Event|Placebo|"placebo 6 pills of inactive drug~Placebo: 6 placebo capsules daily for 8 weeks"
11150007|NCT01874756|EG001|Reported Event|LY500307 25mg|"LY500307 25mg~LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks"
11150008|NCT01874756|EG002|Reported Event|LY500307 75mg|"LY500307 75mg~LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks"
11150009|NCT01874756|EG003|Reported Event|LY500307 150mg|"LY500307 150mg~LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks"
11150010|NCT01874951|BG000|Baseline|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
11150011|NCT01874951|BG001|Baseline|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
11150012|NCT01874951|BG002|Baseline|Total|Total of all reporting groups
11150013|NCT01874951|FG000|Participant Flow|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
11150014|NCT01874951|FG001|Participant Flow|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
11150015|NCT01874951|OG000|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
11150016|NCT01874951|OG001|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
11150017|NCT01874951|OG001|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks.1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
11150018|NCT01874951|OG000|Outcome|Placebo|"In this arm, patients will receive placebo for three weeks.~Placebo: Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo."
11150019|NCT01874951|OG001|Outcome|Naltrexone|In this arm, patients will receive low dose naltrexone for three weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
11150020|NCT01874951|EG000|Reported Event|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
11150021|NCT01874951|EG001|Reported Event|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
11150022|NCT01875159|BG000|Baseline|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
11150023|NCT01875159|BG001|Baseline|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
11150024|NCT01875159|BG002|Baseline|Total|Total of all reporting groups
11150025|NCT01875159|FG000|Participant Flow|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
11146145|NCT01852019|OG001|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146146|NCT01852019|OG002|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146147|NCT01852019|OG000|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146148|NCT01852019|OG001|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146149|NCT01852019|OG001|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
11146150|NCT01852019|EG000|Reported Event|Day 1 - Prasugrel (60mg) at 1.5 Hrs|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.5 hours after infusion start)."
11146151|NCT01852019|EG001|Reported Event|Day 1 - Prasugrel (60mg) at 1.0 hr|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.0 hour after infusion start)."
11146152|NCT01852019|EG002|Reported Event|Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr)|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) post infusion, [at 2.0 hrs, (within 5 minutes of discontinuing the cangrelor infusion)]."
11146153|NCT01852019|EG003|Reported Event|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Subjects were given 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
11146154|NCT01852019|EG004|Reported Event|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Subjects were given 5 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
11146155|NCT01852032|BG000|Baseline|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
11146156|NCT01852032|FG000|Participant Flow|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
11146157|NCT01852032|OG000|Outcome|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
11146158|NCT01852032|EG000|Reported Event|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
11146159|NCT01852045|BG000|Baseline|OnabotulinumtoxinA 50 U|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.
11146160|NCT01852045|BG001|Baseline|OnabotulinumtoxinA 100 U|OnabotulinumtoxinA 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
11146161|NCT01852045|BG002|Baseline|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
11146162|NCT01852045|BG003|Baseline|Total|Total of all reporting groups
11146163|NCT01852045|FG000|Participant Flow|OnabotulinumtoxinA 50 U|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.
11146164|NCT01852045|FG001|Participant Flow|OnabotulinumtoxinA 100 U|OnabotulinumtoxinA 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
11146165|NCT01852045|FG002|Participant Flow|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
11146166|NCT01852045|OG000|Outcome|OnabotulinumtoxinA 50 U|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.
11146167|NCT01852045|OG001|Outcome|OnabotulinumtoxinA 100 U|OnabotulinumtoxinA 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
11146168|NCT01852045|OG002|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
11146169|NCT01852045|EG000|Reported Event|OnabotulinumtoxinA 50 U|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.
11146170|NCT01852045|EG001|Reported Event|OnabotulinumtoxinA 100 U|OnabotulinumtoxinA 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
11146171|NCT01852045|EG002|Reported Event|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
11146172|NCT01852058|BG000|Baseline|OnabotulinumtoxinA 50 U|Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146173|NCT01852058|BG001|Baseline|OnabotulinumtoxinA 100 U|Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146174|NCT01852058|BG002|Baseline|OnabotulinumtoxinA 200 U|Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146175|NCT01852058|BG003|Baseline|Total|Total of all reporting groups
11146176|NCT01852058|FG000|Participant Flow|OnabotulinumtoxinA 50 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146177|NCT01852058|FG001|Participant Flow|OnabotulinumtoxinA 100 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146178|NCT01852058|FG002|Participant Flow|OnabotulinumtoxinA 200 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146179|NCT01852058|FG003|Participant Flow|OnabotulinumtoxinA 50 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146180|NCT01852058|FG004|Participant Flow|OnabotulinumtoxinA 100 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146181|NCT01852058|FG005|Participant Flow|OnabotulinumtoxinA 200 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146182|NCT01852058|FG006|Participant Flow|OnabotulinumtoxinA 50 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
10879930|NCT00460603|BG000|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11348831|NCT04146272|OG000|Outcome|Moderate Hearing Loss Current Mermaid First, Then New|Participants were randomized to wear the current Mermaid hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new Mermaid Hearing aid for another 10 days.
11009531|NCT01102777|OG001|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
11009532|NCT01102777|EG000|Reported Event|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
11150026|NCT01875159|FG001|Participant Flow|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
10887287|NCT00499616|OG001|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11146183|NCT01852058|FG007|Participant Flow|OnabotulinumtoxinA 100 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146184|NCT01852058|FG008|Participant Flow|OnabotulinumtoxinA 200 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146185|NCT01852058|FG009|Participant Flow|OnabotulinumtoxinA 50 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146186|NCT01852058|FG010|Participant Flow|OnabotulinumtoxinA 100 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146187|NCT01852058|FG011|Participant Flow|OnabotulinumtoxinA 200 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146188|NCT01852058|OG000|Outcome|OnabotulinumtoxinA 50 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146189|NCT01852058|OG001|Outcome|OnabotulinumtoxinA 100 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146190|NCT01852058|OG002|Outcome|OnabotulinumtoxinA 200 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146191|NCT01852058|OG000|Outcome|OnabotulinumtoxinA 50 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11225094|NCT02365636|FG002|Participant Flow|Placebo|Placebo ointment applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11225095|NCT02365636|OG000|Outcome|TV-45070 4%|TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11225096|NCT02365636|OG001|Outcome|TV-45070 8%|TV-45070 ointment in a 8% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11225097|NCT02365636|OG002|Outcome|Placebo|Placebo ointment applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11146192|NCT01852058|OG001|Outcome|OnabotulinumtoxinA 100 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146193|NCT01852058|OG002|Outcome|OnabotulinumtoxinA 200 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11225098|NCT02365636|EG000|Reported Event|TV-45070 4%|TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11225099|NCT02365636|EG001|Reported Event|TV-45070 (8%)|TV-45070 ointment in a 8% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11225100|NCT02365636|EG002|Reported Event|Placebo|Placebo ointment applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
11225101|NCT02365714|BG000|Baseline|CyberKnife Arm|Two patients were enrolled for CyberKnife. In one patient, the fiducials were unable to be tracked, so she received external beam partial breast irradiation.
11225102|NCT02365714|FG000|Participant Flow|CyberKnife Arm|This is a single arm study for patients who are eligible for partial breast irradiation.
11225103|NCT02365714|OG000|Outcome|CyberKnife Arm|This is a single arm study for patients who are eligible for partial breast irradiation.
11225104|NCT02365714|EG000|Reported Event|Treatment-Radiation|"CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days.~CK Stereotactic Accelerated Partial Breast Irradiation: Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days."
11225105|NCT02365870|BG000|Baseline|Rotigotine|"rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks~rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily"
11225106|NCT02365870|BG001|Baseline|Placebo|"placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks~placebo: Participants will receive a placebo transdermal patch to be worn daily"
11225107|NCT02365870|BG002|Baseline|Total|Total of all reporting groups
11225108|NCT02365870|FG000|Participant Flow|Rotigotine|"rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks~rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily"
11225109|NCT02365870|FG001|Participant Flow|Placebo|"placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks~placebo: Participants will receive a placebo transdermal patch to be worn daily"
11225110|NCT02365870|OG000|Outcome|Rotigotine|"rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks~rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily"
11225111|NCT02365870|OG001|Outcome|Placebo|"placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks~placebo: Participants will receive a placebo transdermal patch to be worn daily"
11225112|NCT02365870|EG000|Reported Event|Rotigotine|"rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks~rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily"
11225113|NCT02365870|EG001|Reported Event|Placebo|"placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks~placebo: Participants will receive a placebo transdermal patch to be worn daily"
11225114|NCT02365961|BG000|Baseline|FI Block|"Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000)~ropivicaine~clonidine~Epinephrine"
11225115|NCT02365961|BG001|Baseline|Local Injection|"Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin~Noropin"
11225116|NCT02365961|BG002|Baseline|Total|Total of all reporting groups
11225117|NCT02365961|FG000|Participant Flow|FI Block|"Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000)~ropivicaine~clonidine~Epinephrine"
11225118|NCT02365961|FG001|Participant Flow|Local Injection|"Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin~Noropin"
11225119|NCT02365961|OG000|Outcome|FI Block|"Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000)~ropivicaine~clonidine~Epinephrine"
11225120|NCT02365961|OG001|Outcome|Local Injection|"Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin~Noropin"
11225121|NCT02365961|EG000|Reported Event|FI Block|"Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000)~ropivicaine~clonidine~Epinephrine"
11225122|NCT02365961|EG001|Reported Event|Local Injection|"Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin~Noropin"
11225123|NCT02366091|BG000|Baseline|Methotrexate|"Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily~Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11225124|NCT02366091|BG001|Baseline|Colchicine|"Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11335428|NCT03550209|EG000|Reported Event|LCPUFA Oil Supplement, Low Dose|"25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11066010|NCT01390818|BG007|Baseline|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11348832|NCT04146272|OG001|Outcome|Moderate Hearing Loss New Mermaid First, Then Current|Participants were randomized to wear the new Mermaid hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current Mermaid Hearing aid for another 10 days.
11348833|NCT04146272|OG002|Outcome|Severe Hearing Loss Current Power First, Then New|Participants were randomized to wear the current power hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new power Hearing aid for another 10 days.
11146194|NCT01852058|OG000|Outcome|OnabotulinumtoxinA 50 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146195|NCT01852058|OG001|Outcome|OnabotulinumtoxinA 100 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11225125|NCT02366091|BG002|Baseline|Methotrexate & Colchicine|"Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily~Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease."
11225126|NCT02366091|BG003|Baseline|Placebo|"Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11225127|NCT02366091|BG004|Baseline|Total|Total of all reporting groups
11225128|NCT02366091|FG000|Participant Flow|Methotrexate|"Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily~Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11146196|NCT01852058|OG002|Outcome|OnabotulinumtoxinA 200 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146197|NCT01852058|OG003|Outcome|OnabotulinumtoxinA 50 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146198|NCT01852058|OG004|Outcome|OnabotulinumtoxinA 100 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146199|NCT01852058|OG005|Outcome|OnabotulinumtoxinA 200 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146200|NCT01852058|OG006|Outcome|OnabotulinumtoxinA 50 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146201|NCT01852058|OG007|Outcome|OnabotulinumtoxinA 100 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146202|NCT01852058|OG008|Outcome|OnabotulinumtoxinA 200 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146203|NCT01852058|OG009|Outcome|OnabotulinumtoxinA 50 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146204|NCT01852058|OG010|Outcome|OnabotulinumtoxinA 100 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146205|NCT01852058|OG011|Outcome|OnabotulinumtoxinA 200 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11150027|NCT01875159|OG000|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
11146206|NCT01852058|OG000|Outcome|OnabotulinumtoxinA 50 U|Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146207|NCT01852058|OG001|Outcome|OnabotulinumtoxinA 100 U|Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146208|NCT01852058|OG002|Outcome|OnabotulinumtoxinA 200 U|Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146209|NCT01852058|EG000|Reported Event|OnabotulinumtoxinA 50 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146210|NCT01852058|EG001|Reported Event|OnabotulinumtoxinA 100 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146211|NCT01852058|EG002|Reported Event|OnabotulinumtoxinA 200 U (Treatment Cycle 1)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146212|NCT01852058|EG003|Reported Event|OnabotulinumtoxinA 50 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146213|NCT01852058|EG004|Reported Event|OnabotulinumtoxinA 100 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146214|NCT01852058|EG005|Reported Event|OnabotulinumtoxinA 200 U (Treatment Cycle 2)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146215|NCT01852058|EG006|Reported Event|OnabotulinumtoxinA 50 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11225129|NCT02366091|FG001|Participant Flow|Colchicine|"Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11146216|NCT01852058|EG007|Reported Event|OnabotulinumtoxinA 100 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146217|NCT01852058|EG008|Reported Event|OnabotulinumtoxinA 200 U (Treatment Cycle 3)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11348834|NCT04146272|OG003|Outcome|Severe Hearing Loss New Power First, Then Current|Participants were randomized to wear the new power hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current power Hearing aid for another 10 days.
11146218|NCT01852058|EG009|Reported Event|OnabotulinumtoxinA 50 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146219|NCT01852058|EG010|Reported Event|OnabotulinumtoxinA 100 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11146220|NCT01852058|EG011|Reported Event|OnabotulinumtoxinA 200 U (Treatment Cycle 4)|OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
11348835|NCT04146272|OG003|Outcome|Severe Hearing Loss New Power First/Current Second|Participants were randomized to wear the new power hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current power Hearing aid for another 10 days.
11146221|NCT01852071|BG000|Baseline|Gene Therapy|"Infusion of autologous CD34+ cells genetically modified by the EF1αS-ADA (EFS-ADA) lentiviral vector (LV)~Busulfan: Busulfan is used for non-myeloablative conditioning~Polyethylene glycol-modified adenosine deaminase (PEG-ADA): PEG-ADA enzyme replacement therapy (ERT) is discontinued at Day 30 +/- 3 days from date of infusion of OTL-101."
11225130|NCT02366091|FG002|Participant Flow|Methotrexate & Colchicine|"Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily~Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease."
11009533|NCT01102777|EG001|Reported Event|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
11009534|NCT01102803|BG000|Baseline|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
11009535|NCT01102803|BG001|Baseline|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
11009536|NCT01102803|BG002|Baseline|Total|Total of all reporting groups
11009537|NCT01102803|FG000|Participant Flow|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
11009538|NCT01102803|FG001|Participant Flow|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
11009539|NCT01102803|OG000|Outcome|DCS+CBT Treatment|Participants receiving DCS augmented CBT
11009540|NCT01102803|OG001|Outcome|Placebo+CBT Treatment|Participants receiving PL augmented CBT
11009541|NCT01102803|OG000|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
11009542|NCT01102803|OG001|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
11009543|NCT01102803|EG000|Reported Event|DCS+CBT|CBT augmented with DCS (50mg)
11009544|NCT01102803|EG001|Reported Event|Pill Placebo + CBT|CBT augmented with sugar pill placebo
11009545|NCT01102894|BG000|Baseline|Low Fiber and High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber~SmartPill : SmartPill"
11146222|NCT01852071|BG001|Baseline|Historical Control Group|Historical data from patients with Severe Combined Immunodeficiency Due to ADA Deficiency (ADA-SCID) who were treated with Hematopoietic Stem Cell Transplantation (HSCT): Historical data from a database of ADA-SCID patients treated with allogeneic HSCT from Great Ormond Street Hospital (GOSH) and Duke University Children's Hospital were collected as comparator group.
11146223|NCT01852071|BG002|Baseline|Total|Total of all reporting groups
11146224|NCT01852071|FG000|Participant Flow|Gene Therapy|"Infusion of autologous CD34+ cells genetically modified by the EF1αS-ADA (EFS-ADA) lentiviral vector (LV)~Busulfan: Busulfan is used for non-myeloablative conditioning~Polyethylene glycol-modified adenosine deaminase (PEG-ADA): PEG-ADA enzyme replacement therapy (ERT) is discontinued at Day 30 +/- 3 days from date of infusion of OTL-101."
11146225|NCT01852071|FG001|Participant Flow|Historical Control Group|Historical data from patients with Severe Combined Immunodeficiency Due to ADA Deficiency (ADA-SCID) who were treated with Hematopoietic Stem Cell Transplantation (HSCT): Historical data from a database of ADA-SCID patients treated with allogeneic HSCT from Great Ormond Street Hospital (GOSH) and Duke University Children's Hospital were collected as comparator group.
11146226|NCT01852071|OG000|Outcome|OTL-101 Gene Therapy|The primary efficacy population consists of all subjects treated with OTL-101 at University of California, Los Angeles/National Institutes of Health (UCLA/NIH)
11146227|NCT01852071|OG001|Outcome|HSCT Controls Without MRD|The primary comparator population from the HSCT historical control group consists of ADA-SCID patients without a medically eligible human leukocyte antigen (HLA)-identical sibling or family donor and treated with HSCT at either GOSH or Duke University between 2000 and 2016.
11146228|NCT01852071|OG002|Outcome|HSCT Controls With MRD|ADA-SCID patients with an Matched Related Donor (MRD) treated with HSCT at either GOSH or Duke University from 2000 to 2016
11146229|NCT01852071|OG003|Outcome|All HSCT Control Group|The complete HSCT historical control group, which consists of ADA-SCID patients with any type of donor treated with HSCT at either GOSH or Duke University from 2000 to 2016
11146230|NCT01852071|OG000|Outcome|OTL-101 Gene Therapy|The primary efficacy population consists of all subjects treated with OTL-101 at UCLA/NIH
11146231|NCT01852071|OG001|Outcome|HSCT Controls Without MRD|The primary comparator population from the HSCT historical control group consists of ADA-SCID patients without a medically eligible HLA-identical sibling or family donor and treated with HSCT at either GOSH or Duke University between 2000 and 2016.
11146232|NCT01852071|OG002|Outcome|HSCT Controls With MRD|ADA-SCID patients with an MRD treated with HSCT at either GOSH or Duke University from 2000 to 2016
11146233|NCT01852071|OG002|Outcome|All HSCT Control Group|The complete HSCT historical control group, which consists of ADA-SCID patients with any type of donor treated with HSCT at either GOSH or Duke University from 2000 to 2016
11225131|NCT02366091|FG003|Participant Flow|Placebo|"Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11225132|NCT02366091|OG000|Outcome|Methotrexate|"Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily~Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11146234|NCT01852071|OG000|Outcome|OTL-101 Gene Therapy|The primary safety population consists of all subjects treated with OTL-101 at UCLA/NIH
11146235|NCT01852071|EG000|Reported Event|OTL-101 Gene Therapy|The safety population consists of all subjects treated with OTL-101 at UCLA/NIH
11146236|NCT01852084|BG000|Baseline|Control IOL|Control IOL - Spherical control lens
11146237|NCT01852084|BG001|Baseline|Toric IOL1.25 D|Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
11146238|NCT01852084|BG002|Baseline|Toric IOL 2.00 D|Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
11146239|NCT01852084|BG003|Baseline|Toric IOL 2.75 D|Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
11146240|NCT01852084|BG004|Baseline|Total|Total of all reporting groups
11146241|NCT01852084|FG000|Participant Flow|Control IOL|Control IOL - Spherical control lens
11146242|NCT01852084|FG001|Participant Flow|Toric IOL1.25 D|Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
11146243|NCT01852084|FG002|Participant Flow|Toric IOL 2.00 D|Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
11146244|NCT01852084|FG003|Participant Flow|Toric IOL 2.75 D|Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
11146245|NCT01852084|OG000|Outcome|Control IOL|Control IOL - Spherical control lens
11146246|NCT01852084|OG001|Outcome|Toric IOL1.25 D|Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
11146247|NCT01852084|OG002|Outcome|Toric IOL 2.00 D|Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
11146248|NCT01852084|OG003|Outcome|Toric IOL 2.75 D|Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
11146249|NCT01852084|EG000|Reported Event|Control IOL|Control IOL - Spherical control lens
11146250|NCT01852084|EG001|Reported Event|Toric IOL1.25 D|Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
11146251|NCT01852084|EG002|Reported Event|Toric IOL 2.00 D|Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
11146252|NCT01852084|EG003|Reported Event|Toric IOL 2.75 D|Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
11146253|NCT01852110|BG000|Baseline|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
11146254|NCT01852110|BG001|Baseline|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
11146255|NCT01852110|BG002|Baseline|Total|Total of all reporting groups
11146256|NCT01852110|FG000|Participant Flow|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
11146257|NCT01852110|FG001|Participant Flow|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
11146258|NCT01852110|FG002|Participant Flow|MK-7622 Low Dose - 5 mg (Stage 2)|Single 5 mg MK-7622 capsule once daily, taken orally.
11146259|NCT01852110|FG003|Participant Flow|MK-7622 Mid Dose - 15 mg (Stage 2)|Single 15 mg MK-7622 capsule once daily, taken orally.
11146260|NCT01852110|FG004|Participant Flow|MK-7622 High Dose - 45 mg (Stage 2)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
11146261|NCT01852110|FG005|Participant Flow|Placebo (Stage 2)|Matching placebo to MK-7622 capsule once daily, taken orally.
11146262|NCT01852110|OG000|Outcome|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
11146263|NCT01852110|OG001|Outcome|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
11146264|NCT01852110|OG000|Outcome|MK-7622 Mid Dose - 15 mg (Stage 2)|Single 15 mg MK-7622 capsule once daily, taken orally.
11146265|NCT01852110|OG001|Outcome|MK-7622 High Dose - 45 mg (Stage 2)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
11146266|NCT01852110|OG002|Outcome|Placebo (Stage 2)|Matching placebo to MK-7622 capsule once daily, taken orally.
11146267|NCT01852110|OG002|Outcome|MK-7622 Low Dose - 5 mg (Stage 2)|Single 5 mg MK-7622 capsule once daily, taken orally.
11146268|NCT01852110|OG003|Outcome|MK-7622 Mid Dose - 15 mg (Stage 2)|Single 15 mg MK-7622 capsule once daily, taken orally.
11146269|NCT01852110|OG004|Outcome|MK-7622 High Dose - 45 mg (Stage 2)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
11146270|NCT01852110|OG005|Outcome|Placebo (Stage 2)|Matching placebo to MK-7622 capsule once daily, taken orally.
11146271|NCT01852110|OG002|Outcome|MK-7622 Low Dose - 5 mg (Stage 2)|Single 5 mg MK-7622 capsule once daily, taken orally, for 24 weeks
11146272|NCT01852110|EG000|Reported Event|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
11009546|NCT01102894|FG000|Participant Flow|High Fiber and Low Fiber|"Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
11146273|NCT01852110|EG001|Reported Event|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
11146274|NCT01852162|BG000|Baseline|Dabigatran|Dabigatran 150mg tablets
11146275|NCT01852162|BG001|Baseline|Placebo|Placebo tablets
11146276|NCT01852162|BG002|Baseline|Total|Total of all reporting groups
11146277|NCT01852162|FG000|Participant Flow|Dabigatran|Patients randomized to the dabigatran arm received dabigatran 150mg twice/daily for 7 (±3) days.
11146278|NCT01852162|FG001|Participant Flow|Placebo|Patients randomized to the placebo arm received matching placebo tablets twice/daily for 7 (±3) days.
11009547|NCT01102894|OG000|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
11146279|NCT01852162|OG000|Outcome|Dabigatran|Dabigatran 150mg
11146280|NCT01852162|OG001|Outcome|Placebo|Placebo tablets
11146281|NCT01852162|EG000|Reported Event|Dabigatran|Dabigatran 150mg tablets
11146282|NCT01852162|EG001|Reported Event|Placebo|Placebo tablets
11146283|NCT01852175|BG000|Baseline|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
11146284|NCT01852175|BG001|Baseline|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
11146285|NCT01852175|BG002|Baseline|Total|Total of all reporting groups
11146286|NCT01852175|FG000|Participant Flow|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
11146287|NCT01852175|FG001|Participant Flow|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
11146288|NCT01852175|OG000|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
11146289|NCT01852175|OG001|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
11146290|NCT01852175|EG000|Reported Event|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
11146291|NCT01852175|EG001|Reported Event|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
11146292|NCT01852201|BG000|Baseline|Best Medical Therapy|"Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:~General medical management according to AHA/ASA guidelines~Admission to monitored or intensive care unit for at least 24 hours~Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient~Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician~Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines~Follow-up imaging study required in any patient with neurologic deterioration"
11146293|NCT01852201|BG001|Baseline|Endovascular Treatment|"Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.~Endovascular Mechanical Thrombectomy: Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical r"
11146294|NCT01852201|BG002|Baseline|Total|Total of all reporting groups
11146295|NCT01852201|FG000|Participant Flow|Medical Therapy|"Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:~General medical management according to AHA/ASA guidelines~Admission to monitored or intensive care unit for at least 24 hours~Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient~Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician~Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines~Follow-up imaging study required in any patient with neurologic deterioration"
11146296|NCT01852201|FG001|Participant Flow|Endovascular Treatment (Thrombectomy Procedure|"Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.~Endovascular Mechanical Thrombectomy: Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical r"
11150028|NCT01875159|OG001|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
11009548|NCT01102894|OG001|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
11150029|NCT01875159|EG000|Reported Event|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
11150030|NCT01875159|EG001|Reported Event|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
11150031|NCT01875237|BG000|Baseline|Transplant Only|Patients who did not move forward to DLI
11150032|NCT01875237|BG001|Baseline|Transplat Plus DLI|Proceeded to DLI per protocol
11150033|NCT01875237|BG002|Baseline|Total|Total of all reporting groups
11009549|NCT01102894|EG000|Reported Event|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
11150034|NCT01875237|FG000|Participant Flow|Transplant Only|Patients who did not move forward to DLI
11150035|NCT01875237|FG001|Participant Flow|Transplat Plus DLI|Proceeded to DLI per protocol
11150036|NCT01875237|OG000|Outcome|Transplant Only|Participants who did not move forward to DLI
11150037|NCT01875237|OG001|Outcome|Transplat Plus DLI|Proceeded to DLI per protocol
11009550|NCT01102894|EG001|Reported Event|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
11150038|NCT01875237|OG000|Outcome|Transplant Only|Patients who did not move forward to DLI
11009551|NCT01102972|BG000|Baseline|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
11009552|NCT01102972|BG001|Baseline|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
11150039|NCT01875237|OG001|Outcome|Transplat Plus DLI|Proceeded to DLI per protocol and developed GVHD
11150040|NCT01875237|EG000|Reported Event|Transplant Only|Patients who did not move forward to DLI
11150041|NCT01875237|EG001|Reported Event|Transplat Plus DLI|Proceeded to DLI per protocol
11009553|NCT01102972|BG002|Baseline|Total|Total of all reporting groups
11146297|NCT01852201|OG000|Outcome|Best Medical Therapy|"Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:~General medical management according to AHA/ASA guidelines~Admission to monitored or intensive care unit for at least 24 hours~Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient~Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician~Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines~Follow-up imaging study required in any patient with neurologic deterioration"
11146298|NCT01852201|OG001|Outcome|Endovascular Treatment|"Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.~Endovascular Mechanical Thrombectomy: Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revas"
11150042|NCT01875250|BG000|Baseline|Arm A - Enzalutamide for 3 Months|"Enzalutamide for 3 months~Enzalutamide (Xtandi): An androgen receptor inhibitor."
11335429|NCT03550209|EG001|Reported Event|LCPUFA Oil Supplement, Medium Dose|"50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11146299|NCT01852201|OG001|Outcome|Endovascular Treatment|Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.
11150043|NCT01875250|BG001|Baseline|Arm B - Enzalutamide for 3 Months + PSA-TRICOM|"Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21~PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~Enzalutamide (Xtandi): An androgen receptor inhibitor."
11150044|NCT01875250|BG002|Baseline|Total|Total of all reporting groups
11225133|NCT02366091|OG001|Outcome|Colchicine|"Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11348836|NCT04146272|OG000|Outcome|Moderate Hearing Loss Current Mermaid Hearing Aid|Participants with a moderate hearing loss that reported an AE while wearing the Mermaid hearing aid that uses the current feedback cancellation regardless of randomization order.
10887288|NCT00499616|OG000|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11225134|NCT02366091|OG002|Outcome|Methotrexate & Colchicine|"Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily~Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease."
11009554|NCT01102972|FG000|Participant Flow|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
11009555|NCT01102972|FG001|Participant Flow|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
11009556|NCT01102972|OG000|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
11009557|NCT01102972|OG001|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
11009558|NCT01102972|EG000|Reported Event|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
11009559|NCT01102972|EG001|Reported Event|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
11009560|NCT01103063|BG000|Baseline|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
11009561|NCT01103063|BG001|Baseline|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
11009562|NCT01103063|BG002|Baseline|Total|Total of all reporting groups
11009563|NCT01103063|FG000|Participant Flow|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
11009564|NCT01103063|FG001|Participant Flow|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
11009565|NCT01103063|OG000|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
11009566|NCT01103063|OG001|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
11009567|NCT01103063|EG000|Reported Event|Mother (Azithromycin + Chloroquine)|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
11146300|NCT01852201|EG000|Reported Event|Best Medical Therapy|"Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:~General medical management according to AHA/ASA guidelines~Admission to monitored or intensive care unit for at least 24 hours~Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient~Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician~Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines~Follow-up imaging study required in any patient with neurologic deterioration"
11146301|NCT01852201|EG001|Reported Event|Endovascular Treatment|"Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.~Endovascular Mechanical Thrombectomy: Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical re"
11146302|NCT01852214|BG000|Baseline|Overall Population|Subjects with type 2 diabetes mellitus and coronary artery disease
11146303|NCT01852214|FG000|Participant Flow|Prasugrel First, Then Ticagrelor|"Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose~Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose"
11146304|NCT01852214|FG001|Participant Flow|Ticagrelor First, Then Prasugrel|"Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose~Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose"
11146305|NCT01852214|OG000|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
11146306|NCT01852214|OG001|Outcome|Ticagrelor|Patients received a 180mg loading dose and 90mg bid maintenance dose
11146307|NCT01852214|OG001|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
11146308|NCT01852214|EG000|Reported Event|Safety Population: Patients Receiving Prasugrel|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
11009568|NCT01103063|EG001|Reported Event|Mother (Sulfadoxine + Pyrimethamine)|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
11009569|NCT01103063|EG002|Reported Event|Neonate (Azithromycin + Chloroquine)|Live births of participants who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
11150045|NCT01875250|FG000|Participant Flow|Arm A - Enzalutamide for 3 Months|"Enzalutamide for 3 months~Enzalutamide (Xtandi): An androgen receptor inhibitor."
11225135|NCT02366091|OG003|Outcome|Placebo|"Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11335430|NCT03550209|EG002|Reported Event|LCPUFA Oil Supplement, High Dose|"75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days~LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days"
11335431|NCT03550209|EG003|Reported Event|Canola Oil|"Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days~Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days"
11009570|NCT01103063|EG003|Reported Event|Neonate (Sulfadoxine + Pyrimethamine)|Live births of participants who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
10887289|NCT00499616|OG000|Outcome|All Patients|All eligible patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy
11009571|NCT01103141|BG000|Baseline|Micropuncture|Gauge-21 Micropuncture® needle
11009572|NCT01103141|BG001|Baseline|Routine Access|Standard gauge-18 large-bore needle
11009573|NCT01103141|BG002|Baseline|Total|Total of all reporting groups
11009574|NCT01103141|FG000|Participant Flow|Micropuncture|Gauge-21 Micropuncture® needle
11009575|NCT01103141|FG001|Participant Flow|Routine Access|Standard gauge-18 large-bore needle
11009576|NCT01103141|OG000|Outcome|Micropuncture|Gauge-21 Micropuncture® needle
11009577|NCT01103141|OG001|Outcome|Routine Access|Standard gauge-18 large-bore needle
11009578|NCT01103141|EG000|Reported Event|Micropuncture|Gauge-21 Micropuncture® needle
11009579|NCT01103141|EG001|Reported Event|Routine Access|Standard gauge-18 large-bore needle
11009580|NCT01103232|BG000|Baseline|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
11009581|NCT01103232|BG001|Baseline|Control|Transcutaneous electrical nerve stimulation was applied
11146309|NCT01852214|EG001|Reported Event|Safety Population: Patients Receiving Ticagrelor|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
11146310|NCT01852292|BG000|Baseline|Buparlisib + Paclitaxel|Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m^2 weekly.
11146311|NCT01852292|BG001|Baseline|Buparlisib Matching Placebo + Paclitaxel|Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m^2 weekly.
11146312|NCT01852292|BG002|Baseline|Total|Total of all reporting groups
11146313|NCT01852292|FG000|Participant Flow|Buparlisib + Weekly Paclitaxel|Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and weekly paclitaxel.
11146314|NCT01852292|FG001|Participant Flow|Buparlisib Matching Placebo + Paclitaxel|Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and weekly paclitaxel.
11146315|NCT01852292|OG000|Outcome|Buparlisib + Paclitaxel|Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m^2 weekly.
11146316|NCT01852292|OG001|Outcome|Buparlisib Matching Placebo + Paclitaxel|Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m^2 weekly.
11146317|NCT01852292|EG000|Reported Event|Buparlisib + Paclitaxel|Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m^2 weekly.
11146318|NCT01852292|EG001|Reported Event|Buparlisib Matching Placebo + Paclitaxel|Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m^2 weekly.
11348837|NCT04146272|OG001|Outcome|Moderate Hearing Loss New Mermaid Hear Aid|Participants with a moderate hearing loss that reported an AE while wearing the Mermaid hearing aid that uses the new feedback cancellation regardless of randomization order.
11009582|NCT01103232|BG002|Baseline|Total|Total of all reporting groups
11146319|NCT01852344|BG000|Baseline|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
11146320|NCT01852344|BG001|Baseline|Placebo Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
11146321|NCT01852344|BG002|Baseline|Methylphenidate Easy|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
11146322|NCT01852344|BG003|Baseline|Methylphenidate Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
11146323|NCT01852344|BG004|Baseline|Total|Total of all reporting groups
11146324|NCT01852344|FG000|Participant Flow|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
11146325|NCT01852344|FG001|Participant Flow|Placebo Hard|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
11146326|NCT01852344|FG002|Participant Flow|Methylphenidate Easy|Participants are given 20 mgs of methylphenidate one hour before task performance and complete an easy version of the Letter E task.
11146327|NCT01852344|FG003|Participant Flow|Methylphenidate Hard|Healthy participants are given 20 mgs of methylphenidate one hour before task performance and complete a hard version of the Letter E task.
11146328|NCT01852344|OG000|Outcome|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
11146329|NCT01852344|OG001|Outcome|Placebo Hard|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
11146330|NCT01852344|OG002|Outcome|Methylphenidate Easy|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
11146331|NCT01852344|OG003|Outcome|Methylphenidate Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
11146332|NCT01852344|OG000|Outcome|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete and easy version of the Letter E task.
11348838|NCT04146272|OG002|Outcome|Severe Hearing Loss Current Power Hear Aid|Participants with a severe hearing loss that reported an AE while wearing the current Power hearing aid regardless of randomization order.
11009583|NCT01103232|FG000|Participant Flow|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
11009584|NCT01103232|FG001|Participant Flow|Control|Transcutaneous electrical nerve stimulation was applied
11146333|NCT01852344|EG000|Reported Event|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
11146334|NCT01852344|EG001|Reported Event|Placebo Hard|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
11146335|NCT01852344|EG002|Reported Event|Methylphenidate Easy|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
11146336|NCT01852344|EG003|Reported Event|Methylphenidate Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
11146337|NCT01852383|BG000|Baseline|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
11146338|NCT01852383|FG000|Participant Flow|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
11335432|NCT03550313|BG000|Baseline|Group 1: c7vPnC and Prevnar 13 Co-administration|Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.
11009585|NCT01103232|OG000|Outcome|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
11146339|NCT01852383|OG000|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
11225136|NCT02366091|EG000|Reported Event|Methotrexate|"Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily~Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11009586|NCT01103232|OG001|Outcome|Control|Transcutaneous electrical nerve stimulation was applied
11009587|NCT01103232|EG000|Reported Event|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
11348839|NCT04146272|OG003|Outcome|Severe Hearing Loss New Power Hearing Aid|Participants with a severe hearing loss that reported an AE while wearing the new Power hearing aid regardless of randomization order.
11009588|NCT01103232|EG001|Reported Event|Control|Transcutaneous electrical nerve stimulation was applied
11009589|NCT01103245|BG000|Baseline|HCTZ Plus ALI 150 Then ALI 300|Baseline: HCTZ 12.5mg daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month (HCTZ + ALI 150), then Period 2: HCTZ 12.5mg daily plus Aliskiren 300mg for 1 month (HCTZ + ALI 300)
11009590|NCT01103245|BG001|Baseline|HCTZ Plus ALI 150 Then ALI 150 and SPL 25|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month (HCTZ + ALI 150), then Period 2: HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month (HCTZ + ALI 150 and SPL 25)
11009591|NCT01103245|BG002|Baseline|HCTZ Plus SPL 25 Then SPL 50|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month (HCTZ + SPL 25), then Period 2: HCTZ 12.5mg daily plus Spironolactone 50 mg daily for one month (HCTZ + SPL 50)
11009592|NCT01103245|BG003|Baseline|HCTZ Plus SPL 25 Then ALI 150 and SPL 25|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only) Period 1: HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month (HCTZ + SPL 25) Period 2: HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month (HCTZ + ALI 150 and SPL 25)
11009593|NCT01103245|BG004|Baseline|Total|Total of all reporting groups
11009594|NCT01103245|FG000|Participant Flow|HCTZ Plus ALI 150 Then ALI 300|Baseline: HCTZ 12.5mg daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month (HCTZ + ALI 150), then Period 2: HCTZ 12.5mg daily plus Aliskiren 300mg for 1 month (HCTZ + ALI 300)
11009595|NCT01103245|FG001|Participant Flow|HCTZ Plus ALI 150 Then ALI 150 and SPL 25|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month (HCTZ + ALI 150), then Period 2: HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month (HCTZ + ALI 150 and SPL 25)
11009596|NCT01103245|FG002|Participant Flow|HCTZ Plus SPL 25 Then SPL 50|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month (HCTZ + SPL 25), then Period 2: HCTZ 12.5mg daily plus Spironolactone 50 mg daily for one month (HCTZ + SPL 50)
11009597|NCT01103245|FG003|Participant Flow|HCTZ Plus SPL 25 Then ALI 150 and SPL 25|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only) Period 1: HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month (HCTZ + SPL 25) Period 2: HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month (HCTZ + ALI 150 and SPL 25)
11009598|NCT01103245|OG000|Outcome|HCTZ Plus ALI 150 Then ALI 300|Baseline: HCTZ 12.5mg daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month (HCTZ + ALI 150), then Period 2: HCTZ 12.5mg daily plus Aliskiren 300mg for 1 month (HCTZ + ALI 300)
11009599|NCT01103245|OG001|Outcome|HCTZ Plus ALI 150 Then ALI 150 and SPL 25|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month (HCTZ + ALI 150), then Period 2: HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month (HCTZ + ALI 150 and SPL 25)
11009600|NCT01103245|OG002|Outcome|HCTZ Plus SPL 25 Then SPL 50|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month (HCTZ + SPL 25), then Period 2: HCTZ 12.5mg daily plus Spironolactone 50 mg daily for one month (HCTZ + SPL 50)
11009601|NCT01103245|OG003|Outcome|HCTZ Plus SPL 25 Then ALI 150 and SPL 25|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only) Period 1: HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month (HCTZ + SPL 25) Period 2: HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month (HCTZ + ALI 150 and SPL 25)
11009602|NCT01103245|EG000|Reported Event|HCTZ Plus ALI 150 Then ALI 300|Baseline: HCTZ 12.5mg daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month (HCTZ + ALI 150), then Period 2: HCTZ 12.5mg daily plus Aliskiren 300mg for 1 month (HCTZ + ALI 300)
11335433|NCT03550313|BG001|Baseline|Group 2: c7vPnC and Prevnar 13 Staggered Administration|Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.
11225137|NCT02366091|EG001|Reported Event|Colchicine|"Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11150046|NCT01875250|FG001|Participant Flow|Arm B - Enzalutamide for 3 Months + PSA-TRICOM|"Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21~PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~Enzalutamide (Xtandi): An androgen receptor inhibitor."
11146340|NCT01852383|OG000|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.~Administration was as a single a.m. dose.~Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
11146341|NCT01852383|EG000|Reported Event|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
11146342|NCT01852513|BG000|Baseline|QNASL Nasal Spray|"QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment~QNASL"
11146343|NCT01852513|BG001|Baseline|Placebo Nasal Spray|"Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment~Placebo nasal spray"
11146344|NCT01852513|BG002|Baseline|Total|Total of all reporting groups
11146345|NCT01852513|FG000|Participant Flow|QNASL Nasal Spray|"QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment~QNASL"
11146346|NCT01852513|FG001|Participant Flow|Placebo Nasal Spray|"Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment~Placebo nasal spray"
11146347|NCT01852513|OG000|Outcome|QNASL Nasal Spray|"QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment~QNASL"
11146348|NCT01852513|OG001|Outcome|Placebo Nasal Spray|"Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment~Placebo nasal spray"
11146349|NCT01852513|EG000|Reported Event|QNASL Nasal Spray|"QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment~QNASL"
11146350|NCT01852513|EG001|Reported Event|Placebo Nasal Spray|"Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment~Placebo nasal spray"
11146351|NCT01852591|BG000|Baseline|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
11146352|NCT01852591|FG000|Participant Flow|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
11146353|NCT01852591|OG000|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
11146354|NCT01852591|EG000|Reported Event|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
11146355|NCT01852669|BG000|Baseline|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
11146356|NCT01852669|BG001|Baseline|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
11146357|NCT01852669|BG002|Baseline|Total|Total of all reporting groups
11146358|NCT01852669|FG000|Participant Flow|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
11146359|NCT01852669|FG001|Participant Flow|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
11146360|NCT01852669|OG000|Outcome|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
11146361|NCT01852669|OG001|Outcome|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
11146362|NCT01852669|EG000|Reported Event|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
11146363|NCT01852669|EG001|Reported Event|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
11150047|NCT01875250|OG000|Outcome|Arm A - Enzalutamide for 3 Months|"Enzalutamide for 3 months~Enzalutamide (Xtandi): An androgen receptor inhibitor."
11225138|NCT02366091|EG002|Reported Event|Methotrexate & Colchicine|"Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily~Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease."
11225139|NCT02366091|EG003|Reported Event|Placebo|"Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily~Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine."
11335434|NCT03550313|BG002|Baseline|Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose|Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
11335435|NCT03550313|BG003|Baseline|Total|Total of all reporting groups
11146364|NCT01852799|BG000|Baseline|PAD Followed by ASCT|"Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone.~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.~PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle)~Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle)~Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle)~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators."
11146365|NCT01852799|FG000|Participant Flow|PAD Followed by ASCT|"Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone.~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.~PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle)~Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle)~Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle)~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators."
11146366|NCT01852799|OG000|Outcome|PAD Followed by ASCT|"Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone.~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.~PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle)~Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle)~Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle)~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators."
11146367|NCT01852799|EG000|Reported Event|PAD Followed by ASCT|"Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone.~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.~PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle)~Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle)~Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle)~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators."
11146368|NCT01852825|BG000|Baseline|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
11335436|NCT03550313|FG000|Participant Flow|Group 1: c7vPnC and Prevnar 13 Co-administration|Participants who received a dose of complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.
11335437|NCT03550313|FG001|Participant Flow|Group 2: c7vPnC and Prevnar 13 Staggered Administration|Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.
11335438|NCT03550313|FG002|Participant Flow|Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose|Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
10879931|NCT00460603|BG001|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11335439|NCT03550313|OG000|Outcome|Group 1: c7vPnC and Prevnar 13 Co-administration|Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.
11009603|NCT01103245|EG001|Reported Event|HCTZ Plus ALI 150 Then ALI 150 and SPL 25|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month (HCTZ + ALI 150), then Period 2: HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month (HCTZ + ALI 150 and SPL 25)
11335440|NCT03550313|OG001|Outcome|Group 2: c7vPnC and Prevnar 13 Staggered Administration|Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.
11335441|NCT03550313|OG002|Outcome|Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose|Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
11335442|NCT03550313|OG000|Outcome|Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose|Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
11225140|NCT02366130|BG000|Baseline|Ra-223 Dichloride + Denosumab|"Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.~Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.~A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.~Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.~Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.~Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive."
11335443|NCT03550313|EG000|Reported Event|Group 1: c7vPnC and Prevnar 13 Co-administration|Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.
11335444|NCT03550313|EG001|Reported Event|Group 2: c7vPnC and Prevnar 13 Staggered Administration|Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.
11146369|NCT01852825|BG001|Baseline|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
11146370|NCT01852825|BG002|Baseline|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
11146371|NCT01852825|BG003|Baseline|Total|Total of all reporting groups
11146372|NCT01852825|FG000|Participant Flow|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
11146373|NCT01852825|FG001|Participant Flow|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
11146374|NCT01852825|FG002|Participant Flow|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
10879932|NCT00460603|BG002|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11146375|NCT01852825|OG000|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
11146376|NCT01852825|OG001|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
11146377|NCT01852825|OG002|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
11146378|NCT01852825|EG000|Reported Event|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
11146379|NCT01852825|EG001|Reported Event|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
11146380|NCT01852825|EG002|Reported Event|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
11146381|NCT01852942|BG000|Baseline|Losartan|Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
11146382|NCT01852942|BG001|Baseline|Sugar Pill|Placebo: one tablet by mouth daily
11146383|NCT01852942|BG002|Baseline|Total|Total of all reporting groups
11146384|NCT01852942|FG000|Participant Flow|Losartan|Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
11146385|NCT01852942|FG001|Participant Flow|Sugar Pill|Placebo: one tablet by mouth daily
11146386|NCT01852942|OG000|Outcome|Losartan|Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
11146387|NCT01852942|OG001|Outcome|Sugar Pill|Placebo: one tablet by mouth daily
11146388|NCT01852942|OG000|Outcome|Losartan|Losartan: Participants will start with 50 mg of losartan by mouth daily. The dose will be increased to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
11146389|NCT01852942|EG000|Reported Event|Losartan|Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
11146390|NCT01852942|EG001|Reported Event|Sugar Pill|Placebo: one tablet by mouth daily
11146391|NCT01852955|BG000|Baseline|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
11146392|NCT01852955|BG001|Baseline|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
11146393|NCT01852955|BG002|Baseline|Total|Total of all reporting groups
11146394|NCT01852955|FG000|Participant Flow|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
11146395|NCT01852955|FG001|Participant Flow|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
11146396|NCT01852955|OG000|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
11146397|NCT01852955|OG001|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
11146398|NCT01852955|EG000|Reported Event|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
11146399|NCT01852955|EG001|Reported Event|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
11146400|NCT01853046|BG000|Baseline|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
11146401|NCT01853046|BG001|Baseline|Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
11146402|NCT01853046|BG002|Baseline|Total|Total of all reporting groups
11146403|NCT01853046|FG000|Participant Flow|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
11335445|NCT03550313|EG002|Reported Event|Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose|Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
10887290|NCT00499616|EG000|Reported Event|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
11146404|NCT01853046|FG001|Participant Flow|Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
11146405|NCT01853046|OG000|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
11146406|NCT01853046|OG001|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
11009604|NCT01103245|EG002|Reported Event|HCTZ Plus SPL 25 Then SPL 50|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only), then Period 1: HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month (HCTZ + SPL 25), then Period 2: HCTZ 12.5mg daily plus Spironolactone 50 mg daily for one month (HCTZ + SPL 50)
11009605|NCT01103245|EG003|Reported Event|HCTZ Plus SPL 25 Then ALI 150 and SPL 25|Baseline: HCTZ 12.5mg HCTZ daily for 1 month (Baseline, HCTZ only) Period 1: HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month (HCTZ + SPL 25) Period 2: HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month (HCTZ + ALI 150 and SPL 25)
11009606|NCT01103271|BG000|Baseline|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
11009607|NCT01103271|BG001|Baseline|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
11009608|NCT01103271|BG002|Baseline|Total|Total of all reporting groups
11146407|NCT01853046|OG000|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days
11335446|NCT03550378|BG000|Baseline|Placebo|Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
11009609|NCT01103271|FG000|Participant Flow|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
11009610|NCT01103271|FG001|Participant Flow|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
11146408|NCT01853046|EG000|Reported Event|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
11335447|NCT03550378|BG001|Baseline|MEDI0382|Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
10850961|NCT03410992|OG003|Outcome|Bimekizumab 320 mg Q4W/Q8W Escape (ESS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
11335448|NCT03550378|BG002|Baseline|Total|Total of all reporting groups
11335449|NCT03550378|FG000|Participant Flow|Placebo|Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
10850962|NCT03410992|OG004|Outcome|Bimekizumab 320 mg Q4W/Q4W Escape (ESS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
11146409|NCT01853046|EG001|Reported Event|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
11146410|NCT01853072|BG000|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
11146411|NCT01853072|BG001|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
11146412|NCT01853072|BG002|Baseline|Total|Total of all reporting groups
11146413|NCT01853072|FG000|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
11146414|NCT01853072|FG001|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
11146415|NCT01853072|OG000|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
11146416|NCT01853072|OG001|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
11146417|NCT01853072|EG000|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
11146418|NCT01853072|EG001|Reported Event|Nepafenac|All participants treated with Nepafenac during the course of study treatment
11146419|NCT01853072|EG002|Reported Event|Vehicle|All participants treated with NepafenacVehicle during the course of study treatment
11146420|NCT01853072|EG003|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
11335450|NCT03550378|FG001|Participant Flow|MEDI0382|Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
11146421|NCT01853085|BG000|Baseline|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
11146422|NCT01853085|FG000|Participant Flow|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
11009611|NCT01103271|OG000|Outcome|Placebo Effect Study|These were all participants who were screened for the study but not yet enrolled.
11146423|NCT01853085|OG000|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
11146424|NCT01853085|EG000|Reported Event|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
11335451|NCT03550378|OG000|Outcome|Placebo|Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
11146425|NCT01853137|BG000|Baseline|FLMGM Treatment Group|Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance
11146426|NCT01853137|BG001|Baseline|Untreated Class II Control Group|
11146427|NCT01853137|BG002|Baseline|Total|Total of all reporting groups
11146428|NCT01853137|FG000|Participant Flow|FLMGM Treatment Group|Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance
11146429|NCT01853137|FG001|Participant Flow|Untreated Class II Control Group|
11146430|NCT01853137|OG000|Outcome|FLMGM Treatment Group|Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance
11146431|NCT01853137|OG001|Outcome|Untreated Class II Control Group|This is a group of patients classified as Class II patients but they are not treated during the observation period of this study
11146432|NCT01853137|OG001|Outcome|Untreated Class II Control Group|
11146433|NCT01853137|EG000|Reported Event|FLMGM Treatment Group|Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance
11146434|NCT01853137|EG001|Reported Event|Untreated Class II Control Group|
11146435|NCT01853215|BG000|Baseline|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set~T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
11146436|NCT01853215|FG000|Participant Flow|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
11146437|NCT01853215|OG000|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
11146438|NCT01853215|OG000|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
11146439|NCT01853215|EG000|Reported Event|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set~T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
11146440|NCT01853228|BG000|Baseline|Dacogen + Cytarabine|Participants received decitabine 20 milligram per square meter (mg/m^2) by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of each 28-day cycle) in Phase 1 and Phase 2. In addition, participants received cytarabine 1 gram per square meter (g/m^2) (Cohort 1) and 2 g/m^2 (Cohort 2) dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of each 28-day cycle) for the determination of the maximum tolerated dose in Phase 1. The maximum tolerated dose identified in Phase 1 was administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of a 28-day cycle) in Phase 2.
11146441|NCT01853228|FG000|Participant Flow|Cohort 1: Decitabine 20 mg/m^2 + Cytarabine 1 g/m^2|Participants received decitabine 20 milligram per square meter (mg/m^2) by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of each 28-day cycle). In addition, participants received cytarabine 1 gram per square meter (g/m^2) dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of each 28-day cycle) for the determination of the maximum tolerated dose in Cohort 1 of Phase 1.
11146442|NCT01853228|FG001|Participant Flow|Cohort 2: Decitabine 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received decitabine 20 mg/m^2 by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of each 28-day cycle) in Phase 1 and Phase 2. In addition, participants received cytarabine 2 g/m^2 dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of each 28-day cycle) for the determination of the maximum tolerated dose in Cohort 2 of Phase 1. Participants who completed Phase 1 were continued in Phase 2 and received cytarabine at MTD determined in Phase 1 (2 g/m^2) by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of each 28-day cycle).
11146443|NCT01853228|OG000|Outcome|Decitabine (Dacogen) + Cytarabine|Participants received decitabine 20 milligram per square meter (mg/m^2) by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of each 28-day cycle) in Phase 1 and Phase 2. In addition, participants received cytarabine 1 gram per square meter (g/m^2) and 2 g/m^2 dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of each 28-day cycle) for the determination of the maximum tolerated dose in Phase 1. The maximum tolerated dose identified in Phase 1 was administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of a 28-day cycle) in Phase 2.
11146444|NCT01853228|EG000|Reported Event|Phase 1 (Cohort 1): Dacogen + Cytarabine|Participants received decitabine 20 milligram per square meter (mg/m^2) by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of each 28-day cycle) in Phase 1. In addition, participants received cytarabine 1 gram per square meter (g/m^2) and 2 g/m^2 dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of each 28-day cycle) for the determination of the maximum tolerated dose in Phase 1.
11146445|NCT01853228|EG001|Reported Event|Phase 1 (Cohort 2) and Phase 2: Dacogen + Cytarabine|Participants received decitabine 20 mg/m^2 by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of a 28-day cycle) in Phase 1 and Phase 2. In addition, participants received cytarabine 2 g/m^2 dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of a 28-day cycle) for the determination of the maximum tolerated dose in Cohort 2 of Phase 1 and continued to receive (2 g/m^2) in Phase 2.
11146446|NCT01853254|BG000|Baseline|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
11146447|NCT01853254|FG000|Participant Flow|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
11146448|NCT01853254|OG000|Outcome|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
11146449|NCT01853254|EG000|Reported Event|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
11146450|NCT01853280|BG000|Baseline|L-Methylfolate|15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
11146451|NCT01853280|BG001|Baseline|Placebo (for L-Methylfolate)|15 mg matched placebo comparator with open-label OROS-Methylphenidate
11146452|NCT01853280|BG002|Baseline|Total|Total of all reporting groups
11146453|NCT01853280|FG000|Participant Flow|L-Methylfolate|15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
11146454|NCT01853280|FG001|Participant Flow|Placebo (for L-Methylfolate)|15 mg matched placebo comparator with open-label OROS-Methylphenidate
11146455|NCT01853280|OG000|Outcome|L-Methylfolate|15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
11146456|NCT01853280|OG001|Outcome|Placebo (for L-Methylfolate)|15 mg matched placebo comparator with open-label OROS-Methylphenidate
11146457|NCT01853280|EG000|Reported Event|L-Methylfolate|15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
11146458|NCT01853280|EG001|Reported Event|Placebo (for L-Methylfolate)|15 mg matched placebo comparator with open-label OROS-Methylphenidate
11146459|NCT01853332|BG000|Baseline|Cross-Sectional|New and Former Participants
11146460|NCT01853332|FG000|Participant Flow|Cross-Sectional|"New participants: The purpose of the study is to learn about physical health in midlife and how it has been influenced by experiences and relationships. The study specifically targets health differences and the development of heart disease and diabetes.~AND~Former participants (or the partner of a former participant) of the Adolescent and Family Development Project, Young Adult Development Project, Across Generations Project, and/or Paths Over Time Project may already know that this research shows how people grow, individually and as part of a familial and social network, throughout the course of life. This study focuses on learning about former participants' physical health in midlife and how it has been influenced by their experiences and relationships."
11146461|NCT01853332|OG000|Outcome|Cross-Sectional|New participants and former participants
11146462|NCT01853332|OG000|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
11146463|NCT01853332|EG000|Reported Event|Cross-Sectional|New and Former Participants
11146464|NCT01853371|BG000|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
11146465|NCT01853371|BG001|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11146466|NCT01853371|BG002|Baseline|Total|Total of all reporting groups
11146467|NCT01853371|FG000|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other. The wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11146468|NCT01853371|FG001|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11146469|NCT01853371|OG000|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
11146470|NCT01853371|OG001|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11009612|NCT01103271|OG000|Outcome|Open Label-Placebo: Immediate Treatment|Participants assigned to immediate treatment will begin taking placebo pills for four weeks immediately after enrolling in the study.
11146471|NCT01853371|EG000|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
11146472|NCT01853371|EG001|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11335452|NCT03550378|OG001|Outcome|MEDI0382|Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
11146473|NCT01853384|BG000|Baseline|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
11335453|NCT03550378|OG000|Outcome|MEDI0382|Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
11335454|NCT03550378|EG000|Reported Event|Placebo|Participants received subcutaneous dose (SC) of placebo matched to MEDI0382 once daily for 32 days.
11009613|NCT01103271|OG001|Outcome|Placebo Comparator: Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
11348840|NCT04146272|EG000|Reported Event|Moderate Hearing Loss Current Mermaid Hearing Aid|The number of participants with a moderate hearing loss to report an AE while wearing the Mermaid hearing aid with the current feedback system regardless of the randomization order.
10850963|NCT03410992|EG000|Reported Event|Placebo (SS)|Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS).
11146474|NCT01853384|BG001|Baseline|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
11146475|NCT01853384|BG002|Baseline|Total|Total of all reporting groups
11146476|NCT01853384|FG000|Participant Flow|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
11146477|NCT01853384|FG001|Participant Flow|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
11146478|NCT01853384|OG000|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
11146479|NCT01853384|OG001|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
11146480|NCT01853384|EG000|Reported Event|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
11009614|NCT01103271|EG000|Reported Event|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
11009615|NCT01103271|EG001|Reported Event|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
11009616|NCT01103284|BG000|Baseline|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
11009617|NCT01103284|BG001|Baseline|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
11009618|NCT01103284|BG002|Baseline|Total|Total of all reporting groups
11009619|NCT01103284|FG000|Participant Flow|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
11009620|NCT01103284|FG001|Participant Flow|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
11009621|NCT01103284|OG000|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
11009622|NCT01103284|OG001|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
11009623|NCT01103284|EG000|Reported Event|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
11146481|NCT01853384|EG001|Reported Event|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
11146482|NCT01853397|BG000|Baseline|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
11146483|NCT01853397|BG001|Baseline|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
11146484|NCT01853397|BG002|Baseline|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
11146485|NCT01853397|BG003|Baseline|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
11146486|NCT01853397|BG004|Baseline|Total|Total of all reporting groups
11146487|NCT01853397|FG000|Participant Flow|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
11146488|NCT01853397|FG001|Participant Flow|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
11146489|NCT01853397|FG002|Participant Flow|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
11146490|NCT01853397|FG003|Participant Flow|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
11009624|NCT01103284|EG001|Reported Event|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
11146491|NCT01853397|OG000|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
11146492|NCT01853397|OG001|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
11146493|NCT01853397|OG002|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
11009625|NCT01103323|BG000|Baseline|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
11146494|NCT01853397|OG003|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
11146495|NCT01853397|EG000|Reported Event|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
11146496|NCT01853397|EG001|Reported Event|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
11146497|NCT01853397|EG002|Reported Event|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
11146498|NCT01853397|EG003|Reported Event|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
11146499|NCT01853462|BG000|Baseline|Proprioceptive Neuromuscular Facilitation (PNF)|"PNF training~proprioceptive neuromuscular facilitation exercise program: Ten individual sessions (50-60min per session) of PNF training, supervised by a physical therapist"
11146500|NCT01853462|BG001|Baseline|Balance|"Balance training~balance exercise program: Ten individual sessions (50-60min per session) of balance training, supervised by a physical therapist"
11146501|NCT01853462|BG002|Baseline|Total|Total of all reporting groups
11146502|NCT01853462|FG000|Participant Flow|Proprioceptive Neuromuscular Facilitation (PNF)|"PNF training~proprioceptive neuromuscular facilitation exercise program: Ten individual sessions (50-60min per session) of PNF training, supervised by a physical therapist"
11146503|NCT01853462|FG001|Participant Flow|Balance|"Balance training~balance exercise program: Ten individual sessions (50-60min per session) of balance training, supervised by a physical therapist"
11146504|NCT01853462|OG000|Outcome|Proprioceptive Neuromuscular Facilitation (PNF)|Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
11146505|NCT01853462|OG001|Outcome|Balance|Supervised Balance Training
11146506|NCT01853462|OG001|Outcome|Balance|Supervised Balance training
11009626|NCT01103323|BG001|Baseline|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
11009627|NCT01103323|BG002|Baseline|Total|Total of all reporting groups
11146507|NCT01853462|OG000|Outcome|Proprioceptive Neuromuscular Facilitation (PNF)|Supervised Proprioceptive Neuromuscular Facilitation(PNF) Training
11146508|NCT01853462|EG000|Reported Event|Proprioceptive Neuromuscular Facilitation (PNF)|Supervised Proprioceptive Neuromuscular Facilitation (PNF) training
11146509|NCT01853462|EG001|Reported Event|Balance|Supervised Balance Training
11009628|NCT01103323|FG000|Participant Flow|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
11146510|NCT01853475|BG000|Baseline|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
11146511|NCT01853475|BG001|Baseline|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
11146512|NCT01853475|BG002|Baseline|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
11146513|NCT01853475|BG003|Baseline|Total|Total of all reporting groups
11146514|NCT01853475|FG000|Participant Flow|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
11146515|NCT01853475|FG001|Participant Flow|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
11146516|NCT01853475|FG002|Participant Flow|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
11146517|NCT01853475|OG000|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
11146518|NCT01853475|OG001|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
11146519|NCT01853475|OG002|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
11146520|NCT01853475|EG000|Reported Event|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
11146521|NCT01853475|EG001|Reported Event|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
11146522|NCT01853475|EG002|Reported Event|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
11146523|NCT01853553|BG000|Baseline|Spironolactone|"Active arm~Spironolactone~Participants were then randomized by the study coordinator according to a computer-generated random allocation sequence and received either the mineralocorticoid antagonist spironolactone or matching placebo. Participants were dosed at 25 mg/day for 4 weeks, with dosing escalated to 50 mg/day for the remainder of the study if tolerated by an individual participant."
11146524|NCT01853553|BG001|Baseline|Sugar Pill|"Placebo~Sugar pill"
11146525|NCT01853553|BG002|Baseline|Total|Total of all reporting groups
11146526|NCT01853553|FG000|Participant Flow|Spironolactone|"Active arm~Spironolactone~Participants were then randomized by the study coordinator according to a computer-generated random allocation sequence and received either the mineralocorticoid antagonist spironolactone or matching placebo. Participants were dosed at 25 mg/day for 4 weeks, with dosing escalated to 50 mg/day for the remainder of the study if tolerated by an individual participant."
11146527|NCT01853553|FG001|Participant Flow|Sugar Pill|"Placebo~Sugar pill"
11146528|NCT01853553|OG000|Outcome|Spironolactone|"Active arm~Spironolactone"
11146529|NCT01853553|OG001|Outcome|Sugar Pill|"Placebo~Sugar pill"
11146530|NCT01853553|EG000|Reported Event|Spironolactone|"Active arm~Spironolactone 25 mg once daily."
11146531|NCT01853553|EG001|Reported Event|Sugar Pill|"Placebo~Sugar pill-1 tablet once daily."
11146532|NCT01853605|BG000|Baseline|Augmentation|Women undergoing breast augmentation.
11146533|NCT01853605|BG001|Baseline|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
11146534|NCT01853605|BG002|Baseline|Reconstruction|Women undergoing breast reconstruction.
11146535|NCT01853605|BG003|Baseline|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
11146536|NCT01853605|BG004|Baseline|Total|Total of all reporting groups
11146537|NCT01853605|FG000|Participant Flow|Augmentation|Women undergoing breast augmentation.
11146538|NCT01853605|FG001|Participant Flow|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
11146539|NCT01853605|FG002|Participant Flow|Reconstruction|Women undergoing breast reconstruction.
11335455|NCT03550378|EG001|Reported Event|MEDI0382|Participants received SC dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
11335456|NCT03550989|BG000|Baseline|Non-Smokers|"Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.~Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.)."
11146540|NCT01853605|FG003|Participant Flow|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
11146541|NCT01853605|OG000|Outcome|Augmentation|Women undergoing breast augmentation.
11146542|NCT01853605|OG001|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
11146543|NCT01853605|OG002|Outcome|Reconstruction|Women undergoing breast reconstruction.
11146544|NCT01853605|OG003|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
11146545|NCT01853605|EG000|Reported Event|Augmentation|Women undergoing breast augmentation.
11146546|NCT01853605|EG001|Reported Event|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
11146547|NCT01853605|EG002|Reported Event|Reconstruction|Women undergoing breast reconstruction.
11146548|NCT01853605|EG003|Reported Event|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
11146549|NCT01853618|BG000|Baseline|Pilot 1/Arm A1-Tremelimumab + RFA or TACE|"Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 3.5 mg/kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146550|NCT01853618|BG001|Baseline|2/Arm A2 - Tremelimumab + RFA or TACE|"Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146551|NCT01853618|BG002|Baseline|3/Arm B - Tremelimumab + TACE|"Tremelimumab + Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146552|NCT01853618|BG003|Baseline|5/Arm D - Tremelimumab + Cryoablation|"Tremelimumab + Cryoablation~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~Cryoablation: Performed on Day 36"
11146553|NCT01853618|BG004|Baseline|6/Arm E - Tremelimumab + RFA|"Tremelimumab + Radiofrequency Ablation (RFA)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36"
11146554|NCT01853618|BG005|Baseline|Total|Total of all reporting groups
11146555|NCT01853618|FG000|Participant Flow|Pilot 1/Arm A1-Tremelimumab + RFA or TACE|"Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 3.5 mg/kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146556|NCT01853618|FG001|Participant Flow|2/Arm A2 - Tremelimumab + RFA or TACE|"Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146557|NCT01853618|FG002|Participant Flow|3/Arm B - Tremelimumab + TACE|"Tremelimumab + Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146558|NCT01853618|FG003|Participant Flow|5/Arm D - Tremelimumab + Cryoablation|"Tremelimumab + Cryoablation~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~Cryoablation: Performed on Day 36"
11146559|NCT01853618|FG004|Participant Flow|6/Arm E - Tremelimumab + RFA|"Tremelimumab + Radiofrequency Ablation (RFA)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36"
11146560|NCT01853618|OG000|Outcome|Pilot 1/Arm A1-Tremelimumab + RFA or TACE|"Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 3.5 mg/kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146561|NCT01853618|OG001|Outcome|2/Arm A2 - Tremelimumab + RFA or TACE|"Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146562|NCT01853618|OG002|Outcome|3/Arm B - Tremelimumab + TACE|"Tremelimumab + Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146563|NCT01853618|OG003|Outcome|5/Arm D - Tremelimumab + Cryoablation|"Tremelimumab + Cryoablation~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~Cryoablation: Performed on Day 36"
11146564|NCT01853618|OG004|Outcome|6/Arm E - Tremelimumab + RFA|"Tremelimumab + Radiofrequency Ablation (RFA)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36"
11146565|NCT01853618|OG004|Outcome|6/Arm E - Tremelimumab + RFA|"Tremelimumab + Radiofrequency Ablation (RFA)~Tremelimumab:10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36"
11146566|NCT01853618|EG000|Reported Event|Pilot 1/Arm A1-Tremelimumab + RFA or TACE|"Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 3.5 mg/kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146567|NCT01853618|EG001|Reported Event|2/Arm A2 -Tremelimumab + RFA or TACE|"Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146568|NCT01853618|EG002|Reported Event|3/Arm B - Tremelimumab + TACE|"Tremelimumab + Transarterial Catheter Chemoembolization (TACE)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~TACE: Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)"
11146569|NCT01853618|EG003|Reported Event|5/Arm D - Tremelimumab + Cryoablation|"Tremelimumab + Cryoablation~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~Cryoablation: Performed on Day 36"
11146570|NCT01853618|EG004|Reported Event|6/Arm E - Tremelimumab + RFA|"Tremelimumab + Radiofrequency Ablation (RFA)~Tremelimumab: 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years~RFA: Performed on Day 36"
11146571|NCT01853644|BG000|Baseline|Treatment (Tivozanib)|"Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy~Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle"
11146572|NCT01853644|FG000|Participant Flow|Treatment (Tivozanib)|"Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy~Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle"
11146573|NCT01853644|OG000|Outcome|Treatment (Tivozanib)|"Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy~Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle"
11146574|NCT01853644|EG000|Reported Event|Treatment (Tivozanib)|"Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy~Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle"
11146575|NCT01853696|BG000|Baseline|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate"
11146576|NCT01853696|BG001|Baseline|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
11146577|NCT01853696|BG002|Baseline|Total|Total of all reporting groups
11009629|NCT01103323|FG001|Participant Flow|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). Period 1 is placebo and placebo-regorafenib with placebo period only before unblinding. Period 2 is placebo-regorafenib with regorafenib period only.
11146578|NCT01853696|FG000|Participant Flow|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
11146579|NCT01853696|FG001|Participant Flow|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
11146580|NCT01853696|OG000|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
11146581|NCT01853696|OG001|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
11146582|NCT01853696|EG000|Reported Event|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
11146583|NCT01853696|EG001|Reported Event|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
11146584|NCT01853774|BG000|Baseline|Tailored Navigation|"Participants will receive tailored navigation phone calls to assist them with barriers in making a clinic appointment or attending the clinic. The tailored navigation intervention protocol will be used to guide individuals from an especially hard-to-reach, multicultural, and underinsured population into primary care clinics and, subsequently, track the effects of this intervention through a clinic navigation program to complete Colorectal cancer screening.~Tailored navigation"
11146585|NCT01853774|BG001|Baseline|Control|Participants in the control arm will receive phone calls to support data collection and tracking, but not receive tailored messages
11146586|NCT01853774|BG002|Baseline|Total|Total of all reporting groups
11146587|NCT01853774|FG000|Participant Flow|Tailored Navigation|"Participants will receive tailored navigation phone calls to assist them with barriers in making a clinic appointment or attending the clinic. The tailored navigation intervention protocol will be used to guide individuals from an especially hard-to-reach, multicultural, and underinsured population into primary care clinics and, subsequently, track the effects of this intervention through a clinic navigation program to complete Colorectal cancer screening.~Tailored navigation"
11146588|NCT01853774|FG001|Participant Flow|Control|Participants in the control arm will receive phone calls to support data collection and tracking, but not receive tailored messages
11146589|NCT01853774|OG000|Outcome|Tailored Navigation|Tailored Navigation participants received tailored navigation phone calls to assist them with barriers in making a clinic appointment or attending the clinic. The tailored navigation intervention protocol was used to guide individuals community sites into primary care clinics.
11146590|NCT01853774|OG001|Outcome|Control|Control group:participants received phone calls to support data collection and tracking, but not tailored messages, to check if they attended a clinic appointment.
11146591|NCT01853774|OG000|Outcome|Tailored Navigation|Tailored Navigation group participants who completed a CRC screening..
11146592|NCT01853774|OG001|Outcome|Control|Control group participants who completed a CRC screening test.
11146593|NCT01853774|EG000|Reported Event|Tailored Navigation|Participants randomized to the tailored navigation community sites received general education plus tailored navigation (GE+TN) intervention. Participants received tailored navigation phone calls after class completion were encouraged to schedule an appointment at the nearby identified clinic. During the phone calls, trained, culturally sensitive navigators spoke with participants regarding their individual barriers and concerns, using the tailored set of responses from the message library.
11146594|NCT01853774|EG001|Reported Event|Control|Participants randomized to the general education only community sites received general education (GE) intervention. This group of participants received follow up phone calls after class completion, The reason for the phone calls was to check in to find out if participants made a clinic appointment. The calls were strictly follow up.
11335457|NCT03550989|BG001|Baseline|Cigarette Smokers|"Used at least 100 cigarettes~Smokes cigarettes daily > 1/day~Uses IQOS less than daily~Uses less than 30 HeatSticks/month~Cigarette is > 95% of tobacco/nicotine product (all product use)"
10879933|NCT00460603|BG003|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11009630|NCT01103323|OG000|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
11009631|NCT01103323|OG001|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
11009632|NCT01103323|EG000|Reported Event|Regorafenib (BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
11146595|NCT01853839|BG000|Baseline|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
11146596|NCT01853839|FG000|Participant Flow|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
11146597|NCT01853839|OG000|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
11146598|NCT01853839|OG000|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
11146599|NCT01853839|OG001|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
11146600|NCT01853839|OG000|Outcome|Cardiologist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients whose primary physician was a cardiologist."
11146601|NCT01853839|OG001|Outcome|Internist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients whose primary physician was a internist."
11146602|NCT01853839|EG000|Reported Event|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
11146603|NCT01853878|BG000|Baseline|GSK2302032A Group|The patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
11146604|NCT01853878|BG001|Baseline|Placebo Group|The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
11146605|NCT01853878|BG002|Baseline|Total|Total of all reporting groups
11146606|NCT01853878|FG000|Participant Flow|GSK2302032A Group|The patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
11146607|NCT01853878|FG001|Participant Flow|Placebo Group|The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
11146608|NCT01853878|OG000|Outcome|GSK2302032A Group|The patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
11146609|NCT01853878|OG001|Outcome|Placebo Group|The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
11225141|NCT02366130|FG000|Participant Flow|Ra-223 Dichloride + Denosumab|"Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.~Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.~A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.~Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.~Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.~Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive."
11225142|NCT02366130|OG000|Outcome|Ra-223 Dichloride + Denosumab|"Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.~Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.~A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.~Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.~Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.~Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive."
11225143|NCT02366130|EG000|Reported Event|Ra-223 Dichloride + Denosumab|"Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.~Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.~A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.~Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.~Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.~Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive."
11225144|NCT02366143|BG000|Baseline|Arm C|Bevacizumab+Paclitaxel+Carboplatin
11225145|NCT02366143|BG001|Baseline|Arm B|Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin
11225146|NCT02366143|BG002|Baseline|Arm A|Atezolizumab+Paclitaxel+Carboplatin
11225147|NCT02366143|BG003|Baseline|Total|Total of all reporting groups
11225148|NCT02366143|FG000|Participant Flow|Arm C|Bevacizumab+Paclitaxel+Carboplatin
11225149|NCT02366143|FG001|Participant Flow|Arm B|Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin
11225150|NCT02366143|FG002|Participant Flow|Arm A|Atezolizumab+Paclitaxel+Carboplatin
11225151|NCT02366143|OG000|Outcome|Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)|Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
11225152|NCT02366143|OG001|Outcome|Arm C (Bevacizumab+Paclitaxel+Carboplatin)|Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
11225153|NCT02366143|OG000|Outcome|Arm A (Atezolizumab+Paclitaxel+Carboplatin)|Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
11225154|NCT02366143|OG001|Outcome|Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)|Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
11225155|NCT02366143|OG002|Outcome|Arm C (Bevacizumab+Paclitaxel+Carboplatin)|Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
11225156|NCT02366143|OG000|Outcome|Arm C (Bevacizumab+Paclitaxel+Carboplatin)|Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
11225157|NCT02366143|OG002|Outcome|Arm A (Atezolizumab+Paclitaxel+Carboplatin)|Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
11225158|NCT02366143|EG000|Reported Event|Arm C (Bev+CP)|Bevacizumab+Paclitaxel+Carboplatin
11225159|NCT02366143|EG001|Reported Event|Arm B (Atezo+Bev+CP)|Atezolizumab+Bevacizumab+Paclitaxel+Carboplatin
11225160|NCT02366143|EG002|Reported Event|Arm A (Atezo+CP)|Atezolizumab+Paclitaxel+Carboplatin
11335458|NCT03550989|BG002|Baseline|IQOS Passive Users (Not Using IQOS)|"Used at least 100 HeatSticks~Uses IQOS daily > 1/day~Smokes a cigarette less than daily~Smokes less than 30 cigarettes/month~IQOS is > 95% of tobacco/nicotine product (all product use)~excluding other products (e-cig/Ploom/etc.)"
11146610|NCT01853878|EG000|Reported Event|GSK2302032A Group|The patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
11146611|NCT01853878|EG001|Reported Event|Placebo Group|The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
11335459|NCT03550989|BG003|Baseline|IQOS Active Users (Using IQOS)|"Used at least 100 HeatSticks~Uses IQOS daily > 1/day~Smokes a cigarette less than daily~Smokes less than 30 cigarettes/month~IQOS is > 95% of tobacco/nicotine product (all product use)~excluding other products (e-cig/Ploom/etc.)"
11335460|NCT03550989|BG004|Baseline|Total|Total of all reporting groups
11342060|NCT03696342|BG000|Baseline|PRO-157|"Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.~Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
11009633|NCT01103323|EG001|Reported Event|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). It is for placebo period only before unblinding.
10879934|NCT00460603|BG004|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11009634|NCT01103323|EG002|Reported Event|Placebo - Regorafenib After Unblinding|Participants in the placebo+BSC group switched to treatment with Regorafenib after unblinding. It is for Regorafenib treatment period only
11146612|NCT01853930|BG000|Baseline|Laboratory Training|"Patients will be trained in the laboratory by a rehabilitation therapist~The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance."
11009635|NCT01103362|BG000|Baseline|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
11009636|NCT01103362|FG000|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
11009637|NCT01103362|OG000|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
11009638|NCT01103362|EG000|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
11348841|NCT04146272|EG001|Reported Event|Moderate Hearing Loss New Mermaid Hearing Aid|The number of participants with a moderate hearing loss to report an AE while wearing the Mermaid hearing aid with the new feedback system regardless of the randomization order.
11348842|NCT04146272|EG002|Reported Event|Severe Hearing Loss Current Power Hearing Aid|The number of participants with a severe hearing loss to report an AE while wearing the current Power hearing aid regardless of the randomization order.
11009639|NCT01103414|BG000|Baseline|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
11009640|NCT01103414|BG001|Baseline|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
11009641|NCT01103414|BG002|Baseline|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
11146613|NCT01853930|BG001|Baseline|Home-based Training|"Patients will self instruct using the computer-based training with remote intervention by a therapist as needed~The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance."
11146614|NCT01853930|BG002|Baseline|Total|Total of all reporting groups
11146615|NCT01853930|FG000|Participant Flow|Laboratory Training|"Patients will be trained in the laboratory by a rehabilitation therapist~The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance."
11342061|NCT03696342|BG001|Baseline|Zymar|"Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.~Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
11342062|NCT03696342|BG002|Baseline|Total|Total of all reporting groups
11009642|NCT01103414|BG003|Baseline|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
11009643|NCT01103414|BG004|Baseline|Matching Placebo|Over-encapsulated placebo tablet
11146616|NCT01853930|FG001|Participant Flow|Home-based Training|"Patients will self instruct using the computer-based training with remote intervention by a therapist as needed~The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance."
11146617|NCT01853930|OG000|Outcome|Laboratory Training|"Patients will be trained in the laboratory by a rehabilitation therapist~The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance."
11146618|NCT01853930|OG001|Outcome|Home-based Training|"Patients will self instruct using the computer-based training with remote intervention by a therapist as needed~The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance."
11146619|NCT01853930|EG000|Reported Event|Laboratory Training|"Patients will be trained in the laboratory by a rehabilitation therapist~The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance."
11009644|NCT01103414|BG005|Baseline|Total|Total of all reporting groups
11146620|NCT01853930|EG001|Reported Event|Home-based Training|"Patients will self instruct using the computer-based training with remote intervention by a therapist as needed~The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance."
11146621|NCT01854034|BG000|Baseline|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
10887291|NCT00499616|EG001|Reported Event|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11146622|NCT01854034|FG000|Participant Flow|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
11146623|NCT01854034|OG000|Outcome|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
11146624|NCT01854034|EG000|Reported Event|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
11348843|NCT04146272|EG003|Reported Event|Severe Hearing Loss New Power Hearing Aid|The number of participants with a severe hearing loss to report an AE while wearing the new Power hearing aid regardless of the randomization order.
11009645|NCT01103414|FG000|Participant Flow|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
11225161|NCT02366195|BG000|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter. Participants were treated with talimogene laherparepvec until they achieved a complete response, all injectable tumors had disappeared, clinically significant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of treatment, per modified World Health Organization (WHO) response criteria, or intolerance of study treatment, whichever occurred first.
11009646|NCT01103414|FG001|Participant Flow|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
11009647|NCT01103414|FG002|Participant Flow|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
11009648|NCT01103414|FG003|Participant Flow|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
11335715|NCT03555266|BG000|Baseline|NSS-2 Bridge and ERAS Protocol|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.~NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol."
11009649|NCT01103414|FG004|Participant Flow|Matching Placebo|Over-encapsulated placebo tablet
11146625|NCT01854047|BG000|Baseline|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11009650|NCT01103414|OG000|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
11146626|NCT01854047|BG001|Baseline|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146627|NCT01854047|BG002|Baseline|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11009651|NCT01103414|OG001|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
11146628|NCT01854047|BG003|Baseline|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146629|NCT01854047|BG004|Baseline|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146630|NCT01854047|BG005|Baseline|Total|Total of all reporting groups
11146631|NCT01854047|FG000|Participant Flow|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11348844|NCT04143945|BG000|Baseline|Overall Study|Participants were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
11009652|NCT01103414|OG002|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
11009653|NCT01103414|OG003|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
11009654|NCT01103414|OG004|Outcome|Matching Placebo|Over-encapsulated placebo tablet
11009655|NCT01103414|EG000|Reported Event|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
11009656|NCT01103414|EG001|Reported Event|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
11009657|NCT01103414|EG002|Reported Event|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
11009658|NCT01103414|EG003|Reported Event|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
11009659|NCT01103414|EG004|Reported Event|Matching Placebo|Over-encapsulated placebo tablet
11146632|NCT01854047|FG001|Participant Flow|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146633|NCT01854047|FG002|Participant Flow|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146634|NCT01854047|FG003|Participant Flow|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146635|NCT01854047|FG004|Participant Flow|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146636|NCT01854047|OG000|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146637|NCT01854047|OG001|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146638|NCT01854047|OG002|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146639|NCT01854047|OG003|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146640|NCT01854047|OG004|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11146641|NCT01854047|EG000|Reported Event|Placebo|Participants exposed to Placebo (for Dupilumab) added to stable ICS/LABA therapy (mean exposure of 23 weeks).
11146642|NCT01854047|EG001|Reported Event|Dupilumab 300 mg q2w|Participants exposed to Dupilumab 300 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
11146643|NCT01854047|EG002|Reported Event|Dupilumab 200 mg q2w|Participants exposed to Dupilumab 200 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
11146644|NCT01854047|EG003|Reported Event|Dupilumab 300 mg q4w|Participants exposed to Dupilumab 300 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
11348845|NCT04143945|FG000|Participant Flow|Sequence A: DV3396 (Right) Then PDS290 (Left)|Participants were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11146645|NCT01854047|EG004|Reported Event|Dupilumab 200 mg q4w|Participants exposed to Dupilumab 200 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
11146646|NCT01854138|BG000|Baseline|Control|Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.
11146647|NCT01854138|BG001|Baseline|Prevena Hip/Knee|"Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound.~Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.~Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days."
11146648|NCT01854138|BG002|Baseline|Total|Total of all reporting groups
11146649|NCT01854138|FG000|Participant Flow|Control|Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.
11146650|NCT01854138|FG001|Participant Flow|Prevena Hip/Knee|"Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasy and receiving Prevena Incision Management System on the clean surgical wound.~Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.~Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days."
11146651|NCT01854138|OG000|Outcome|Control|Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.
11146652|NCT01854138|OG001|Outcome|Prevena Knee/Hip|"Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound.~Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days."
11146653|NCT01854138|OG001|Outcome|Prevena Hip/Knee|"Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasy and receiving Prevena Incision Management System on the clean surgical wound.~Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.~Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days."
11146654|NCT01854138|EG000|Reported Event|Control|Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.
11146655|NCT01854138|EG001|Reported Event|Prevena Hip/Knee|"Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasy and receiving Prevena Incision Management System on the clean surgical wound.~Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.~Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days."
11146656|NCT01854177|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Aprepitant first and placebo
11146657|NCT01854177|FG000|Participant Flow|Overall Study Population|Participants who consented and received both Aprepitant 125 mg taken orally and Placebo (Inert capsule taken orally) in random order 2-3 days apart.
11146658|NCT01854177|OG000|Outcome|Aprepitant|aprepitant 125 mg taken orally
11146659|NCT01854177|OG001|Outcome|Placebo|inert capsule taken orally
11146660|NCT01854177|EG000|Reported Event|Aprepitant|aprepitant 125 mg taken orally
11146661|NCT01854177|EG001|Reported Event|Placebo|inert capsule taken orally
11146662|NCT01854242|BG000|Baseline|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
11146663|NCT01854242|FG000|Participant Flow|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
11146664|NCT01854242|OG000|Outcome|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
11146665|NCT01854242|EG000|Reported Event|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
11146666|NCT01854281|BG000|Baseline|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
11146667|NCT01854281|BG001|Baseline|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
11146668|NCT01854281|BG002|Baseline|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
11146669|NCT01854281|BG003|Baseline|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
11146670|NCT01854281|BG004|Baseline|Total|Total of all reporting groups
11146671|NCT01854281|FG000|Participant Flow|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
11146672|NCT01854281|FG001|Participant Flow|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after Dive A.
11146673|NCT01854281|FG002|Participant Flow|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
11146674|NCT01854281|FG003|Participant Flow|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after Dive B.
11146675|NCT01854281|OG000|Outcome|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
11146676|NCT01854281|OG001|Outcome|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
11146677|NCT01854281|OG002|Outcome|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
11146678|NCT01854281|OG003|Outcome|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
11146679|NCT01854281|EG000|Reported Event|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
11146680|NCT01854281|EG001|Reported Event|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
11146681|NCT01854281|EG002|Reported Event|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
11146682|NCT01854281|EG003|Reported Event|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
11146683|NCT01854359|BG000|Baseline|Active Treatment in 09-I-0197|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~This group completed a total of 3 years of Idebenone treatment."
11146684|NCT01854359|BG001|Baseline|Placebo in 09-I-0197|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~This group completed a total of 1 year of Idebenone treatment (following 2 years of placebo treatment in the 09-I-0197 trial)"
11146685|NCT01854359|BG002|Baseline|Total|Total of all reporting groups
11146686|NCT01854359|FG000|Participant Flow|Active Treatment in 09-I-0197|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~This group completed a total of 3 years of Idebenone treatment"
11146687|NCT01854359|FG001|Participant Flow|Placebo in 09-I-0197|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~This group completed a total of 1 year of Idebenone treatment (following 2 years of placebo treatment in the 09-I-0198 trial)."
11146688|NCT01854359|OG000|Outcome|Pre-treatment Baseline (Placebo Group)|One Year Pre-treatment baseline of the 09-I-0197 trial for placebo group
11146689|NCT01854359|OG001|Outcome|Double-blind Phase (Placebo Group)|Two-Year Double-blind Phase of 09-I-0197 (placebo group)
11146690|NCT01854359|OG002|Outcome|Extension Phase (Placebo Group)|One-year open label active treatment group that received placebo in the 09-I-0197 trial
11146691|NCT01854359|OG003|Outcome|Pre-treatment Baseline (Active Treatment Group)|One Year Pre-treatment baseline of the 09-I-0197 trial for active treatment group
11146692|NCT01854359|OG004|Outcome|Double-blind Phase (Active Treatment Group)|Two-Year Double-blind Phase of 09-I-0197 (active treatment group)
11146693|NCT01854359|OG005|Outcome|Extension Phase (Active Treatment Group)|One-year open label active treatment group that received active treatment in the 09-I-0197 trial
11146694|NCT01854359|OG000|Outcome|Placebo Arm of the 09-I-0197|placebo arm of the 09-I-0197 - one year pre-treatment baseline plus two years of placebo during the double-blind phase of 09-I-0197
11146695|NCT01854359|OG001|Outcome|Extension Phase (Placebo Arm)|One-year open label extension phase of the 09-I-0917 placebo arm
11146696|NCT01854359|OG002|Outcome|Active Treatment Arm of the 09-I-0197|active treatment arm of the 09-I-0197 - one year pre-treatment baseline plus two years of Idebenone treatment during the double-blind phase of 09-I-0197
11146697|NCT01854359|OG003|Outcome|Extension Phase (Active Treatment Arm)|One-year open label extension phase of the 09-I-0917 active treatment arm
11146698|NCT01854359|EG000|Reported Event|Active Treatment in 09-I-0197|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~Two years of Idebenone treatment during the 09-I-0197 double-blind phase"
11146699|NCT01854359|EG001|Reported Event|Placebo in 09-I-0197|"Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.~Two years of placebo during the 09-I-0197 double-blind phase"
11146700|NCT01854528|BG000|Baseline|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11146701|NCT01854528|BG001|Baseline|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
11146702|NCT01854528|BG002|Baseline|Total|Total of all reporting groups
11146703|NCT01854528|FG000|Participant Flow|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11146704|NCT01854528|FG001|Participant Flow|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
11146705|NCT01854528|OG000|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11146706|NCT01854528|OG001|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
11146707|NCT01854528|EG000|Reported Event|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11146708|NCT01854528|EG001|Reported Event|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
11146709|NCT01854593|BG000|Baseline|Bevacizumab and Vitrectomy|"0.16 mg/0.05 ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
11146710|NCT01854593|BG001|Baseline|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Sham injection: Sham injection one day before vitrectomy~Vitrectomy: vitrectomy of 25 gauge system."
11146711|NCT01854593|BG002|Baseline|Total|Total of all reporting groups
11146712|NCT01854593|FG000|Participant Flow|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
11146713|NCT01854593|FG001|Participant Flow|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Sham injection: Sham injection one day before vitrectomy~Vitrectomy: vitrectomy of 25 gauge system."
11146714|NCT01854593|OG000|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
11146715|NCT01854593|OG001|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
11146716|NCT01854593|OG000|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
11146717|NCT01854593|EG000|Reported Event|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
11146718|NCT01854593|EG001|Reported Event|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
11146719|NCT01854632|BG000|Baseline|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
11146720|NCT01854632|BG001|Baseline|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
11146721|NCT01854632|BG002|Baseline|Total|Total of all reporting groups
11146722|NCT01854632|FG000|Participant Flow|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
11146723|NCT01854632|FG001|Participant Flow|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
11146724|NCT01854632|OG000|Outcome|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
11146725|NCT01854632|OG001|Outcome|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
11146726|NCT01854632|EG000|Reported Event|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
11146727|NCT01854632|EG001|Reported Event|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
11146728|NCT01854645|BG000|Baseline|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
11146729|NCT01854645|BG001|Baseline|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
11146730|NCT01854645|BG002|Baseline|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
11146731|NCT01854645|BG003|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
11146732|NCT01854645|BG004|Baseline|Placebo|Placebo MDI
11146733|NCT01854645|BG005|Baseline|Total|Total of all reporting groups
11146734|NCT01854645|FG000|Participant Flow|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
11009660|NCT01103440|BG000|Baseline|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
11146735|NCT01854645|FG001|Participant Flow|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
11146736|NCT01854645|FG002|Participant Flow|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
11146737|NCT01854645|FG003|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
11146738|NCT01854645|FG004|Participant Flow|Placebo|Placebo MDI
11146739|NCT01854645|OG000|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
11146740|NCT01854645|OG001|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
11146741|NCT01854645|OG002|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
11146742|NCT01854645|OG003|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
11146743|NCT01854645|OG004|Outcome|Placebo|Placebo MDI
11146744|NCT01854645|EG000|Reported Event|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
11146745|NCT01854645|EG001|Reported Event|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
11146746|NCT01854645|EG002|Reported Event|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
11146747|NCT01854645|EG003|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
11146748|NCT01854645|EG004|Reported Event|Placebo|Placebo MDI
11146749|NCT01854658|BG000|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
11146750|NCT01854658|BG001|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
11146751|NCT01854658|BG002|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
11146752|NCT01854658|BG003|Baseline|Placebo MDI|Inhaled placebo administered as two puffs BID
11146753|NCT01854658|BG004|Baseline|Total|Total of all reporting groups
11146754|NCT01854658|FG000|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
11009661|NCT01103440|BG001|Baseline|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
11348846|NCT04143945|FG001|Participant Flow|Sequence B: DV3396 (Left) Then PDS290 (Right)|Participants were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11009662|NCT01103440|BG002|Baseline|Total|Total of all reporting groups
11009663|NCT01103440|FG000|Participant Flow|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
11146755|NCT01854658|FG001|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
11146756|NCT01854658|FG002|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
11146757|NCT01854658|FG003|Participant Flow|Placebo MDI|Inhaled placebo administered as two puffs BID
11146758|NCT01854658|OG000|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
11146759|NCT01854658|OG001|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
11146760|NCT01854658|OG002|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
11146761|NCT01854658|OG003|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
11146762|NCT01854658|EG000|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
11146763|NCT01854658|EG001|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
11341333|NCT03681405|OG001|Outcome|Group II (AC)|"Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.~Questionnaire Administration: Ancillary studies~Telephone-Based Intervention: Receive caring attention phone call"
11009664|NCT01103440|FG001|Participant Flow|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
11146764|NCT01854658|EG002|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
11146765|NCT01854658|EG003|Reported Event|Placebo MDI|Inhaled placebo administered as two puffs BID
11009665|NCT01103440|OG000|Outcome|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
11009666|NCT01103440|OG001|Outcome|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
11009667|NCT01103440|EG000|Reported Event|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
11146766|NCT01854697|BG000|Baseline|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
11146767|NCT01854697|BG001|Baseline|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
11146768|NCT01854697|BG002|Baseline|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
11146769|NCT01854697|BG003|Baseline|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
11146770|NCT01854697|BG004|Baseline|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
11146771|NCT01854697|BG005|Baseline|Total|Total of all reporting groups
11146772|NCT01854697|FG000|Participant Flow|Arm A: 3-DAA + RBV in GT1a|ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 Direct-Acting Antivirals (DAAs) with RBV in genotype [GT] 1a)
11146773|NCT01854697|FG001|Participant Flow|Arm B: TPV/PR in GT1a|Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
11009668|NCT01103440|EG001|Reported Event|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
11009669|NCT01103466|BG000|Baseline|All Study Parcipitants|All parcipitants recieved all three intervention and they are therefore combined into one group.
11009670|NCT01103466|FG000|Participant Flow|Atlas|"New base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
11009671|NCT01103466|FG001|Participant Flow|SenSura|"Commercially available base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
11009672|NCT01103466|FG002|Participant Flow|Conform2|"Commercially available base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
11342063|NCT03696342|FG000|Participant Flow|PRO-157|"Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.~Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
11009673|NCT01103466|OG000|Outcome|Atlas|new base plate
11225162|NCT02366195|FG000|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter. Participants were treated with talimogene laherparepvec until they achieved a complete response, all injectable tumors had disappeared, clinically significant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of treatment, per modified World Health Organization (WHO) response criteria, or intolerance of study treatment, whichever occurred first.
10879935|NCT00460603|BG005|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879936|NCT00460603|BG006|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879937|NCT00460603|BG007|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11009674|NCT01103466|OG001|Outcome|SenSura|base plate
11342064|NCT03696342|FG001|Participant Flow|Zymar|"Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.~Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
11009675|NCT01103466|OG002|Outcome|Conform2|base plate
11348847|NCT04143945|FG002|Participant Flow|Sequence C: PDS290 (Right) Then DV3396 (Left)|Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11009676|NCT01103466|EG000|Reported Event|Atlas|new base plate
11009677|NCT01103466|EG001|Reported Event|SenSura|base plate
11009678|NCT01103466|EG002|Reported Event|Conform2|base plate
11146774|NCT01854697|FG002|Participant Flow|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
11146775|NCT01854697|FG003|Participant Flow|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
11009679|NCT01103479|BG000|Baseline|Control|Participants will complete interviewer-administered pre- and post-test
11009680|NCT01103479|BG001|Baseline|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
11146776|NCT01854697|FG004|Participant Flow|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
11146777|NCT01854697|OG000|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
11348848|NCT04143945|FG003|Participant Flow|Sequence D: PDS290 (Left) Then DV3396 (Right)|Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11146778|NCT01854697|OG001|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
11146779|NCT01854697|OG002|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
11146780|NCT01854697|OG003|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
11009681|NCT01103479|BG002|Baseline|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
11009682|NCT01103479|BG003|Baseline|Total|Total of all reporting groups
11009683|NCT01103479|FG000|Participant Flow|Control|Participants will complete interviewer-administered pre- and post-test
11009684|NCT01103479|FG001|Participant Flow|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
11009685|NCT01103479|FG002|Participant Flow|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
11009686|NCT01103479|OG000|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
11009687|NCT01103479|OG001|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training~Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
11009688|NCT01103479|OG000|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
11009689|NCT01103479|OG001|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
11009690|NCT01103479|EG000|Reported Event|Control|Participants will complete interviewer-administered pre- and post-test
11009691|NCT01103479|EG001|Reported Event|Physician Training|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
11009692|NCT01103479|EG002|Reported Event|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
11009693|NCT01103492|BG000|Baseline|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
11009694|NCT01103492|FG000|Participant Flow|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
11009695|NCT01103492|OG000|Outcome|Ablation Treatment|Subjects with radiation proctitis who met inclusion criteria
11009696|NCT01103492|EG000|Reported Event|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
11009697|NCT01103505|BG000|Baseline|Device Monitoring Arm|"participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device.~ForeseeHome"
11009698|NCT01103505|BG001|Baseline|Standard Care (Control) Arm|Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD.
11009699|NCT01103505|BG002|Baseline|Total|Total of all reporting groups
11009700|NCT01103505|FG000|Participant Flow|Device Monitoring Arm|Participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device.
11009701|NCT01103505|FG001|Participant Flow|Standard Care (Control) Arm|Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD.
11009702|NCT01103505|OG000|Outcome|ForeseeHome + Standard Care at CNV Progression|Patients who progressed from intermediate AMD to CNV and who were randomized to ForeseeHome use + Standard Care at the time CNV developed
11009703|NCT01103505|OG001|Outcome|Standard Care Alone (Control) at CNV Progression|Patients who progressed from intermediate AMD to CNV and were randomized to Standard Care alone (control arm) at the time CNV developed.
11009704|NCT01103505|OG000|Outcome|Device Monitoring Arm|Participants in the ForeseeHome use + Standard Care monitoring arm who maintained 20/40 or better vision at time of CNV detection
11009705|NCT01103505|OG001|Outcome|Standard Care (Control) Arm|Participants in the Standard Care alone monitoring arm who maintained 20/40 or better vision at time of CNV detection
11009706|NCT01103505|OG000|Outcome|Device Monitoring Arm|Lesion size (total lesion area) of participants in the ForeseeHome use + Standard Care monitoring arm at time of CNV detection
11348849|NCT04143945|OG000|Outcome|DV3396|Participants were to receive a s.c. injection of DV3396 product (0.25 mg of semaglutide) on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
11348850|NCT04143945|OG001|Outcome|PDS290|Participants were to receive a s.c. injection of PDS290 product (0.25 mg of semaglutide) on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
11348851|NCT04143945|EG000|Reported Event|Overall Study|Participants were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
11146781|NCT01854697|OG004|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
11146782|NCT01854697|EG000|Reported Event|3 DAA + RBV|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks
11146783|NCT01854697|EG001|Reported Event|3 DAA|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks
11009707|NCT01103505|OG001|Outcome|Standard Care (Control) Arm|Lesion size (total lesion area) of participants in the Standard Care alone monitoring arm at time of CNV detection
11146784|NCT01854697|EG002|Reported Event|TPV + PEGIFN + RBV|TPV 750 mg q8h and pegIFN 180 μg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir
11146785|NCT01854710|BG000|Baseline|All Subjects Treated|All 6 treatment sequences = Safety Population
11146786|NCT01854710|FG000|Participant Flow|Treatment Sequence ABC|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
11146787|NCT01854710|FG001|Participant Flow|Treatment Sequence ACB|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
11146788|NCT01854710|FG002|Participant Flow|Treatment Sequence BCA|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
11146789|NCT01854710|FG003|Participant Flow|Treatment Sequence BAC|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
11146790|NCT01854710|FG004|Participant Flow|Treatment Sequence CAB|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
11146791|NCT01854710|FG005|Participant Flow|Treatment Sequence CBA|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
11348852|NCT04143373|BG000|Baseline|All Study Participants|"In this study, during impacted mandibular third molar surgery, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side was irrigated with normal saline of 37 ± 1 ° C as for the experimental side.~The side for each intervention was determined by a table of random numbers."
11009708|NCT01103505|OG000|Outcome|Device Monitoring Arm|Lesion size (CNV lesion area) of participants in the ForeseeHome use + Standard Care monitoring arm at time of CNV detection
11146792|NCT01854710|OG000|Outcome|ADASUVE-Placebo Crossover Subjects|"All subjects who completed both treatments A and B: Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo.~The analyses are based on a within (paired) comparison of the time matched drug - placebo QTc values."
11009709|NCT01103505|OG001|Outcome|Standard Care (Control) Arm|Lesion size (CNV lesion area) of participants in the Standard Care alone monitoring arm at time of CNV detection
11009710|NCT01103505|OG000|Outcome|Device Monitoring Arm|Lesion size (fluid area) of participants in the ForeseeHome use + Standard Care monitoring arm at time of CNV detection
11146793|NCT01854710|OG000|Outcome|ADASUVE 10 mg x 2 Doses|"ADASUVE QTcI, Differences from Placebo in Change from Pre-dose Baseline and One-sided 95% Upper Confidence Bound (msec)~QTcI associated with mean Cmax"
11146794|NCT01854710|OG000|Outcome|Inhaled Placebo + Oral Placebo|"Staccato Placebo 2 doses 2 hours apart + Oral Placebo~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
11146795|NCT01854710|OG001|Outcome|ADASUVE 10 mg x 2 Doses|"ADASUVE 10 mg 2 doses 2 hours apart + Oral Placebo~ADASUVE 10 mg 2 doses 2 hours apart: inhaled loxapine~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
11009711|NCT01103505|OG001|Outcome|Standard Care (Control) Arm|Lesion size (fluid area) of participants in the Standard Care alone monitoring arm at time of CNV detection
11009712|NCT01103505|EG000|Reported Event|Device Monitoring Arm|Participants in the ForeseeHome AMD device monitoring arm will receive a device for at home use, with instructions to install and connect the device to a modem as well as instructions for daily use of the device, in addition to standard care.
11009713|NCT01103505|EG001|Reported Event|Standard Care (Control) Arm|Standard care arm study participants will receive instruction per clinic routine for home vision monitoring (e.g. Amsler grid) to detect progression of AMD in addition to routine scheduled eye exams
11225163|NCT02366195|OG000|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter. Participants were treated with talimogene laherparepvec until they achieved a complete response, all injectable tumors had disappeared, clinically significant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of treatment, per modified World Health Organization (WHO) response criteria, or intolerance of study treatment, whichever occurred first.
11225164|NCT02366195|EG000|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter. Participants were treated with talimogene laherparepvec until they achieved a complete response, all injectable tumors had disappeared, clinically significant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of treatment, per modified World Health Organization (WHO) response criteria, or intolerance of study treatment, whichever occurred first.
11225165|NCT02366312|BG000|Baseline|NBCCS-associated KCOT|Nevoid Basal Cell Carcinoma Syndrome (NBCCS)-associated Keratocystic Odontogenic Tumor (KCOT) Group
11225166|NCT02366312|BG001|Baseline|Sporadic KCOT|Sporadic Keratocystic Odontogenic Tumor (KCOT) Group
11225167|NCT02366312|BG002|Baseline|Total|Total of all reporting groups
11225168|NCT02366312|FG000|Participant Flow|NBCCS-associated KCOT|Nevoid Basal Cell Carcinoma Syndrome (NBCCS)-associated Keratocystic Odontogenic Tumor (KCOT) Group
11225169|NCT02366312|FG001|Participant Flow|Sporadic KCOT|Sporadic Keratocystic Odontogenic Tumor (KCOT) Group
11225170|NCT02366312|OG000|Outcome|NBCCS-associated KCOT|Nevoid Basal Cell Carcinoma Syndrome (NBCCS)-associated Keratocystic Odontogenic Tumor (KCOT) Group
11225171|NCT02366312|OG001|Outcome|Sporadic KCOT|Sporadic Keratocystic Odontogenic Tumor (KCOT) Group
11225172|NCT02366312|EG000|Reported Event|NBCCS-associated KCOT|Nevoid Basal Cell Carcinoma Syndrome (NBCCS)-associated Keratocystic Odontogenic Tumor (KCOT) Group
11225173|NCT02366312|EG001|Reported Event|Sporadic KCOT|Sporadic Keratocystic Odontogenic Tumor (KCOT) Group
11225174|NCT02366338|BG000|Baseline|Group 1|patients on warfarin therapy
11225175|NCT02366338|BG001|Baseline|Group 2|patients on rivaroxaban therapy
11225176|NCT02366338|BG002|Baseline|Group 3|Patients on dabigatran therapy
11225177|NCT02366338|BG003|Baseline|Total|Total of all reporting groups
11225178|NCT02366338|FG000|Participant Flow|Group 1|patients on warfarin therapy
11225179|NCT02366338|FG001|Participant Flow|Group 2|patients on rivaroxaban therapy
11225180|NCT02366338|FG002|Participant Flow|Group 3|Patients on dabigatran therapy
11225181|NCT02366338|OG000|Outcome|Group 1|patients on warfarin therapy
11225182|NCT02366338|OG001|Outcome|Group 2|patients on rivaroxaban therapy
11225183|NCT02366338|OG002|Outcome|Group 3|Patients on dabigatran therapy
11225184|NCT02366338|EG000|Reported Event|Group 1|patients on warfarin therapy
11225185|NCT02366338|EG001|Reported Event|Group 2|patients on rivaroxaban therapy
11225186|NCT02366338|EG002|Reported Event|Group 3|Patients on dabigatran therapy
11225187|NCT02366468|BG000|Baseline|Discretion of the Investigator (DI)|Investigational - ranibizumab 0.5 mg
11225188|NCT02366468|BG001|Baseline|Pro re Nata (PRN)|Standard of Care - ranibizumab 0.5 mg
11225189|NCT02366468|BG002|Baseline|Total|Total of all reporting groups
11225190|NCT02366468|FG000|Participant Flow|Discretion of the Investigator (DI)|Investigational - ranibizumab 0.5 mg
11225191|NCT02366468|FG001|Participant Flow|Pro re Nata (PRN)|Standard of Care - ranibizumab 0.5 mg
11225192|NCT02366468|OG000|Outcome|Discretion of the Investigator (DI)|Investigational - ranibizumab 0.5 mg
11225193|NCT02366468|OG001|Outcome|Pro re Nata (PRN)|Standard of Care - ranibizumab 0.5 mg
11225194|NCT02366468|EG000|Reported Event|Discretion of the Investigator (DI)|Investigational - ranibizumab 0.5 mg
11225195|NCT02366468|EG001|Reported Event|Pro re Nata (PRN)|Standard of Care - ranibizumab 0.5 mg
11225196|NCT02366611|BG000|Baseline|Transcranial Direct Current Stimulation (tDCS)|"tDCS is a method of non-invasive brain stimulation that is based on the application of a weak direct current to the head that flows between two relatively large electrodes-anode and cathode. tDCS offers a unique analgesic modality of central pain neuromodulation by altering the activity of key sensory and motor cortical structures. Participants in this arm will undergo 20 tDCS sessions, tDCS in clinic and remotely supervised tDCS, and 2mA of transcranial direct current stimulation will be applied for 20 minutes.~Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain neuromodulatory method that involves sending a weak electrical current to the brain. 2mA of tDCS will be applied for 20 minutes at each session and participants will undergo a total of 20 sessions over a 7-week period."
11225197|NCT02366611|BG001|Baseline|Chemoradiotherapy Standard of Care|The control group will consist of patients receiving the Standard of care and no neuromodulation.
11225198|NCT02366611|BG002|Baseline|Total|Total of all reporting groups
11225199|NCT02366611|FG000|Participant Flow|Transcranial Direct Current Stimulation (tDCS)|"tDCS is a method of non-invasive brain stimulation that is based on the application of a weak direct current to the head that flows between two relatively large electrodes-anode and cathode. tDCS offers a unique analgesic modality of central pain neuromodulation by altering the activity of key sensory and motor cortical structures. Participants in this arm will undergo 20 tDCS sessions, tDCS in clinic and remotely supervised tDCS, and 2mA of transcranial direct current stimulation will be applied for 20 minutes.~Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain neuromodulatory method that involves sending a weak electrical current to the brain. 2mA of tDCS will be applied for 20 minutes at each session and participants will undergo a total of 20 sessions over a 7-week period."
11009714|NCT01103713|BG000|Baseline|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
11225200|NCT02366611|FG001|Participant Flow|Chemoradiotherapy Standard of Care|The control group will consist of patients receiving the Standard of care and no neuromodulation.
11342065|NCT03696342|OG000|Outcome|PRO-157|"Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.~Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
10849042|NCT00293384|FG000|Participant Flow|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
11146796|NCT01854710|OG000|Outcome|Moxifloxacin QT Crossover Subjects|"All subjects who completed both Treatments B and C: B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo.~Analyses are based on a within (paired) comparison of the time matched drug - placebo QTc values."
11146797|NCT01854710|EG000|Reported Event|Inhaled Placebo + Oral Placebo|"Staccato Placebo 2 doses 2 hours apart + Oral Placebo~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
11146798|NCT01854710|EG001|Reported Event|ADASUVE 10 mg x 2 Doses|"ADASUVE 10 mg 2 doses 2 hours apart + Oral Placebo~ADASUVE 10 mg 2 doses 2 hours apart: inhaled loxapine~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
11225201|NCT02366611|OG000|Outcome|Transcranial Direct Current Stimulation (tDCS)|"tDCS is a method of non-invasive brain stimulation that is based on the application of a weak direct current to the head that flows between two relatively large electrodes-anode and cathode. tDCS offers a unique analgesic modality of central pain neuromodulation by altering the activity of key sensory and motor cortical structures. Participants in this arm will undergo 20 tDCS sessions, tDCS in clinic and remotely supervised tDCS, and 2mA of transcranial direct current stimulation will be applied for 20 minutes.~Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain neuromodulatory method that involves sending a weak electrical current to the brain. 2mA of tDCS will be applied for 20 minutes at each session and participants will undergo a total of 20 sessions over a 7-week period."
11225202|NCT02366611|OG001|Outcome|Chemoradiotherapy Standard of Care|The control group will consist of patients receiving the Standard of care and no neuromodulation.
11146799|NCT01854710|EG002|Reported Event|Oral Moxifloxacin|"Staccato Placebo 2 doses 2 hours apart + Oral moxifloxacin 400 mg~Oral moxifloxacin 400 mg~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler"
11225203|NCT02366611|OG001|Outcome|Chemoradiotherapy Standard of Care|The control group will consist of patients receiving the standard of care and no neuromodulation.
11342066|NCT03696342|OG001|Outcome|Zymar|"Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.~Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
10849043|NCT00293384|OG000|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
11009715|NCT01103713|FG000|Participant Flow|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
11150048|NCT01875250|OG001|Outcome|Arm B - Enzalutamide for 3 Months + PSA-TRICOM|"Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21~PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~Enzalutamide (Xtandi): An androgen receptor inhibitor."
11150049|NCT01875250|OG000|Outcome|All Participants|All participants who received Enzalutamide for 3 months and Enzalutamide 3 months + PSA-TRICOM.
11009716|NCT01103713|OG000|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
11009717|NCT01103713|OG000|Outcome|Azithromycin/Chloroquine (AZCQ)|This is an open label, single arm study conducted in pregnant women during their second and third trimesters of pregnancy. Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
11150050|NCT01875250|OG000|Outcome|All Participants|All participants who received Enzalutamide for 3 months and Enzalutamide 3 months + PSA-TRICOM,
11150051|NCT01875250|EG000|Reported Event|Arm A - Enzalutamide for 3 Months|"Enzalutamide for 3 months~Enzalutamide (Xtandi): An androgen receptor inhibitor."
11009718|NCT01103713|OG000|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
11009719|NCT01103713|EG000|Reported Event|Azithromycin/Chloroquine (Familial Status = Neonate)|AZCQ (Familial Status = Neonate)
11009720|NCT01103713|EG001|Reported Event|Azithromycin/Chloroquine (Familial Status = Mother)|ACZQ (Familial Status = Mother)
11009721|NCT01103778|BG000|Baseline|Velcade® Therapy|Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
11009722|NCT01103778|FG000|Participant Flow|Velcade Arm|"Single treatment arm:~Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle)."
11009723|NCT01103778|OG000|Outcome|Velcade® Therapy|"Patients with greater than 1gm of proteinuria per day will receive Velcade®.~Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle)."
11009724|NCT01103778|OG000|Outcome|Velcade Arm|"Single treatment arm:~Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle)."
10879938|NCT00460603|BG008|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879939|NCT00460603|BG009|Baseline|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879940|NCT00460603|BG010|Baseline|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879941|NCT00460603|BG011|Baseline|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879942|NCT00460603|BG012|Baseline|Total|Total of all reporting groups
10879943|NCT00460603|FG000|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 milligram per square meter (mg/m^2) intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-fluorouracil (5-FU) 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879944|NCT00460603|FG001|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879945|NCT00460603|FG002|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10887292|NCT00499616|EG002|Reported Event|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11009725|NCT01103778|OG000|Outcome|Velcade Arm|Single treatment arm
11009726|NCT01103778|EG000|Reported Event|Velcade® Therapy|"Patients with greater than 1gm of proteinuria per day will receive Velcade®.~Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle)."
10879946|NCT00460603|FG003|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879947|NCT00460603|FG004|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879948|NCT00460603|FG005|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879949|NCT00460603|FG006|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879950|NCT00460603|FG007|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879951|NCT00460603|FG008|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879952|NCT00460603|FG009|Participant Flow|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879953|NCT00460603|FG010|Participant Flow|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879954|NCT00460603|FG011|Participant Flow|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11150052|NCT01875250|EG001|Reported Event|Arm B - Enzalutamide for 3 Months + PSA-TRICOM|"Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21~PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~Enzalutamide (Xtandi): An androgen receptor inhibitor."
11150053|NCT01875367|BG000|Baseline|Arm A: T-IV + T-SC Vial + T-SC Device|Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.
11150054|NCT01875367|BG001|Baseline|Arm B: T-IV + T-SC Device + T-SC Vial|Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
11150055|NCT01875367|BG002|Baseline|Total|Total of all reporting groups
10879955|NCT00460603|OG000|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879956|NCT00460603|OG001|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879957|NCT00460603|OG002|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879958|NCT00460603|OG000|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879959|NCT00460603|OG001|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879960|NCT00460603|OG002|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879961|NCT00460603|OG000|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11009727|NCT01103934|BG000|Baseline|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
11009728|NCT01103934|BG001|Baseline|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
11150056|NCT01875367|FG000|Participant Flow|Arm A: T-IV + T-SC Vial + T-SC Device|Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.
11009729|NCT01103934|BG002|Baseline|Total|Total of all reporting groups
11009730|NCT01103934|FG000|Participant Flow|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
10879962|NCT00460603|OG001|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879963|NCT00460603|OG000|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879964|NCT00460603|OG000|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879965|NCT00460603|OG001|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879966|NCT00460603|OG002|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879967|NCT00460603|EG000|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879968|NCT00460603|EG001|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879969|NCT00460603|EG002|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10887293|NCT00499616|EG003|Reported Event|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.~Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
11150057|NCT01875367|FG001|Participant Flow|Arm B: T-IV + T-SC Device + T-SC Vial|Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
11150058|NCT01875367|OG000|Outcome|Arm A: T-IV + T-SC Vial + T-SC Device|Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.
10879970|NCT00460603|EG003|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879971|NCT00460603|EG004|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879972|NCT00460603|EG005|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879973|NCT00460603|EG006|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879974|NCT00460603|EG007|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879975|NCT00460603|EG008|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879976|NCT00460603|EG009|Reported Event|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879977|NCT00460603|EG010|Reported Event|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
11146813|NCT01854827|BG000|Baseline|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
10879978|NCT00460603|EG011|Reported Event|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
10879979|NCT00460655|BG000|Baseline|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
10879980|NCT00460655|BG001|Baseline|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
10879981|NCT00460655|BG002|Baseline|Total|Total of all reporting groups
10879982|NCT00460655|FG000|Participant Flow|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
10879983|NCT00460655|FG001|Participant Flow|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
10879984|NCT00460655|FG002|Participant Flow|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
10879985|NCT00460655|FG003|Participant Flow|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
10879986|NCT00460655|OG000|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
10879987|NCT00460655|OG001|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
10879988|NCT00460655|OG000|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
10879989|NCT00460655|OG001|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
10879990|NCT00460655|EG000|Reported Event|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
10879991|NCT00460655|EG001|Reported Event|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
10879992|NCT00460655|EG002|Reported Event|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
10879993|NCT00460655|EG003|Reported Event|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
10879994|NCT00460746|BG000|Baseline|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
10879995|NCT00460746|FG000|Participant Flow|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
10879996|NCT00460746|OG000|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
10879997|NCT00460746|EG000|Reported Event|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
10879998|NCT00460798|BG000|Baseline|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
11009731|NCT01103934|FG001|Participant Flow|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
11150059|NCT01875367|OG001|Outcome|Arm B: T-IV + T-SC Device + T-SC Vial|Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
11150060|NCT01875367|OG000|Outcome|Both Arms|Questionnaires were given to the health care professionals of both arms. There have been completed 39 health care professional satisfaction questionnaires. Information not provided by arm.
11150061|NCT01875367|OG000|Outcome|Both Arms: Intravenous-Trastuzumab (IV-t)|Patients from both arms (A and B) who received Intravenous-Trastuzumab as per clinical practice.
11225204|NCT02366611|EG000|Reported Event|Transcranial Direct Current Stimulation (tDCS)|"tDCS is a method of non-invasive brain stimulation that is based on the application of a weak direct current to the head that flows between two relatively large electrodes-anode and cathode. tDCS offers a unique analgesic modality of central pain neuromodulation by altering the activity of key sensory and motor cortical structures. Participants in this arm will undergo 20 tDCS sessions, tDCS in clinic and remotely supervised tDCS, and 2mA of transcranial direct current stimulation will be applied for 20 minutes.~Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain neuromodulatory method that involves sending a weak electrical current to the brain. 2mA of tDCS will be applied for 20 minutes at each session and participants will undergo a total of 20 sessions over a 7-week period."
10879999|NCT00460798|FG000|Participant Flow|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
10880000|NCT00460798|OG000|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
10880001|NCT00460798|EG000|Reported Event|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
10880002|NCT00460811|BG000|Baseline|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
10880003|NCT00460811|BG001|Baseline|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
10880004|NCT00460811|BG002|Baseline|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
10880005|NCT00460811|BG003|Baseline|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
10880006|NCT00460811|BG004|Baseline|Matching Placebo|Dose-matched placebo, oral administration, once per day
10880007|NCT00460811|BG005|Baseline|Total|Total of all reporting groups
10880008|NCT00460811|FG000|Participant Flow|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
10880009|NCT00460811|FG001|Participant Flow|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
10880010|NCT00460811|FG002|Participant Flow|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
10880011|NCT00460811|FG003|Participant Flow|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
10880012|NCT00460811|FG004|Participant Flow|Matching Placebo|Dose-matched placebo, oral administration, once per day
10880013|NCT00460811|OG000|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
10880014|NCT00460811|OG001|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
10880015|NCT00460811|OG002|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
10880016|NCT00460811|OG003|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
10880017|NCT00460811|OG004|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
10880018|NCT00460811|OG000|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
10880019|NCT00460811|OG001|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
10880020|NCT00460811|OG002|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
10880021|NCT00460811|OG003|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
10880022|NCT00460811|OG004|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
10880023|NCT00460811|EG000|Reported Event|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
10880024|NCT00460811|EG001|Reported Event|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
10880025|NCT00460811|EG002|Reported Event|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
10880026|NCT00460811|EG003|Reported Event|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
10880027|NCT00460811|EG004|Reported Event|Matching Placebo|Dose-matched placebo, oral administration, once per day
10880028|NCT00460993|BG000|Baseline|Group 1|Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.
10880029|NCT00460993|BG001|Baseline|Group 2|"Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.~Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve."
10880030|NCT00460993|BG002|Baseline|Total|Total of all reporting groups
10880031|NCT00460993|FG000|Participant Flow|Group 1|Active drug during phase 1, then placebo during phase 2. Lunesta Active drug (eszopiclone) 1 mg for 3 days. If sleep efficiency does not improve in 3 three day, dose increases to 2 mg for the next three days of active drug administration.
10880032|NCT00460993|FG001|Participant Flow|Group 2|Placebo during phase 1, then active drug phase 2. One placebo for 6 days
10880033|NCT00460993|OG000|Outcome|Group 1|Active drug given in phase 1, then Placebo pill in phase 2. Lunesta Active drug (eszopiclone) 1 mg during three days of active drug. If sleep efficiency does not improve doses increases to 2 mg for the next three days of active drug administration.
10880034|NCT00460993|OG001|Outcome|Group 2|Placebo pill in phase 1, then Active drug given in phase 2. One placebo pill for 6 days
10880035|NCT00460993|EG000|Reported Event|Group 1|Active drug given in phase 1, then placebo pill given in phase 2.
10880036|NCT00460993|EG001|Reported Event|Group 2|Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days.
10880037|NCT00461045|BG000|Baseline|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
10880038|NCT00461045|FG000|Participant Flow|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
10880039|NCT00461045|OG000|Outcome|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
10880040|NCT00461045|EG000|Reported Event|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
10887143|NCT00499083|FG000|Participant Flow|Vaccine|"Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.~Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.~Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion~All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections."
10880041|NCT00461097|BG000|Baseline|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
10880042|NCT00461097|BG001|Baseline|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
10880043|NCT00461097|BG002|Baseline|Total|Total of all reporting groups
10880044|NCT00461097|FG000|Participant Flow|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
10880045|NCT00461097|FG001|Participant Flow|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
10880046|NCT00461097|OG000|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
10880047|NCT00461097|OG001|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
10880048|NCT00461097|EG000|Reported Event|Egg Oral Immunotherapy (OIT), 0-2 Years|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day. A 10 gm OFC to identify desensitized [1] subjects occurs at month 22. Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC at year 2. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
11009732|NCT01103934|OG000|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
11150062|NCT01875367|OG001|Outcome|Both Arms: Subcutaneous-Trastuzumab Vial (SC-t Vial)|Patients from both arms (A and B) who received Subcutaneous (SC) injection vial.
10880049|NCT00461097|EG001|Reported Event|Placebo, 0-2 Years|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
10880050|NCT00461097|EG002|Reported Event|Egg Oral Immunotherapy (OIT), 2-4 Years|"Subjects who failed the 1st or 2nd 10 gm OFC at month 22 or year 2 continue on their egg OIT maintenance dose of 2 gm/day of egg white solid (EWS) or are allowed to attempt escalation up to 2 gm/day for the remainder of the study. Subjects who are not considered tolerant may have a 10 gm OFC at year 3 and year 4 to assess desensitization. Subjects who pass the 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.~Note: The total number of subjects assessed for non-systematic adverse events was 36 (subjects with post 2-year follow-up) and for systematic adverse events was 22 (subjects with post 2-year dosing)."
10880051|NCT00461123|BG000|Baseline|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
10880052|NCT00461123|BG001|Baseline|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
10880053|NCT00461123|BG002|Baseline|Total|Total of all reporting groups
10880054|NCT00461123|FG000|Participant Flow|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
10880055|NCT00461123|FG001|Participant Flow|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
10880056|NCT00461123|OG000|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
10880057|NCT00461123|OG001|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
10880058|NCT00461123|EG000|Reported Event|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
10880059|NCT00461123|EG001|Reported Event|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
10880060|NCT00461175|BG000|Baseline|LNG IUS|New users of Mirena® IUS
10880061|NCT00461175|BG001|Baseline|Copper IUD|New users of Copper IUD
10880062|NCT00461175|BG002|Baseline|Total|Total of all reporting groups
10880063|NCT00461175|FG000|Participant Flow|LNG IUS|New users of Mirena® IUS
10880064|NCT00461175|FG001|Participant Flow|Copper IUD|New users of Copper IUD
10880065|NCT00461175|OG000|Outcome|LNG IUS|New users of Mirena® IUS
10880066|NCT00461175|OG001|Outcome|Copper IUD|New users of Copper IUD
10880067|NCT00461175|EG000|Reported Event|LNG IUS|New users of Mirena® IUS
10880068|NCT00461175|EG001|Reported Event|Copper IUD|New users of Copper IUD
10880069|NCT00461253|BG000|Baseline|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
10880070|NCT00461253|BG001|Baseline|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
10880071|NCT00461253|BG002|Baseline|Total|Total of all reporting groups
10880072|NCT00461253|FG000|Participant Flow|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
10880073|NCT00461253|FG001|Participant Flow|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
10880074|NCT00461253|OG000|Outcome|LNG IUD|Women who currently or ever used a LNG IUDs (Mirena) at time of breast cancer diagnosis
10880075|NCT00461253|OG001|Outcome|Cu-IUD|Women who currently or ever used a copper IUDs at time of breast cancer diagnosis
10880076|NCT00461253|EG000|Reported Event|LNG IUD|Users of LNG IUDs (Mirena)
10880077|NCT00461253|EG001|Reported Event|Cu-IUD|Users of copper IUDs
10880078|NCT00461292|BG000|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
10880079|NCT00461292|BG001|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10880080|NCT00461292|BG002|Baseline|Placebo|Normal saline (placebo)
10880081|NCT00461292|BG003|Baseline|Total|Total of all reporting groups
10880082|NCT00461292|FG000|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
10880083|NCT00461292|FG001|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10880084|NCT00461292|FG002|Participant Flow|Placebo|Normal saline (placebo)
10880085|NCT00461292|OG000|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
10880086|NCT00461292|OG001|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10880087|NCT00461292|OG002|Outcome|Placebo|Normal saline (placebo)
10880088|NCT00461292|EG000|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
10880089|NCT00461292|EG001|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10880090|NCT00461292|EG002|Reported Event|Placebo|Normal saline (placebo)
10880091|NCT00461305|BG000|Baseline|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
10880092|NCT00461305|BG001|Baseline|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
10880093|NCT00461305|BG002|Baseline|Total|Total of all reporting groups
10880094|NCT00461305|FG000|Participant Flow|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
10880095|NCT00461305|FG001|Participant Flow|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
10880096|NCT00461305|OG000|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
10880097|NCT00461305|OG001|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
10880098|NCT00461305|OG000|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
10880099|NCT00461305|EG000|Reported Event|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
10880100|NCT00461305|EG001|Reported Event|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
10880101|NCT00461331|BG000|Baseline|Entire Study Population|These are the characteristics of the entire study population.
10880102|NCT00461331|FG000|Participant Flow|Aspart First, Washout, Then Lispro|Patients used Aspart Insulin for up to 100 hours, then entered a two week wash out period, then used Lispro insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
10880103|NCT00461331|FG001|Participant Flow|Lispro First, Washout, Then Aspart|Patients used Lispro Insulin for up to 100 hours, then entered a two week wash out period, then used Aspart insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
10880104|NCT00461331|OG000|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
10880105|NCT00461331|OG001|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
10880106|NCT00461331|OG001|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
10880107|NCT00461331|EG000|Reported Event|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
10880108|NCT00461331|EG001|Reported Event|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
10880109|NCT00461500|BG000|Baseline|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|Analysis population used in this arm is ITT (intent-to-treat) population (Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
10880110|NCT00461500|BG001|Baseline|FP 100: Fluticasone Propionate.|Analysis population used in this arm is ITT population(Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
10880111|NCT00461500|BG002|Baseline|Total|Total of all reporting groups
10880112|NCT00461500|FG000|Participant Flow|SFC (Salmeterol Xinafoate/Fluticasone Propionate Combination)|Analysis population are all randomized subjects in this arm. 50/100ug - one inhalation twice daily
11225205|NCT02366611|EG001|Reported Event|Chemoradiotherapy Standard of Care|The control group will consist of patients receiving the Standard of care and no neuromodulation.
11225206|NCT02366637|BG000|Baseline|All Participants|All participants who received at least 1 dose of study drug (PF-03715455 or placebo).
11225207|NCT02366637|FG000|Participant Flow|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
11225208|NCT02366637|FG001|Participant Flow|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
11225209|NCT02366637|OG000|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
11225210|NCT02366637|OG001|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
11225211|NCT02366637|EG000|Reported Event|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
11225212|NCT02366637|EG001|Reported Event|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
11225213|NCT02366663|BG000|Baseline|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
11225214|NCT02366663|BG001|Baseline|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
11225215|NCT02366663|BG002|Baseline|Total|Total of all reporting groups
11225216|NCT02366663|FG000|Participant Flow|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
11225217|NCT02366663|FG001|Participant Flow|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
11225218|NCT02366663|OG000|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
10880113|NCT00461500|FG001|Participant Flow|FP (Fluticasone Propionate)100|Analysis population are all randomized subjects in this arm. 100ug - one inhalation twice daily
11225219|NCT02366663|OG001|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
11342067|NCT03696342|EG000|Reported Event|PRO-157|"Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.~Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
11225220|NCT02366663|EG000|Reported Event|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
11225221|NCT02366663|EG001|Reported Event|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
11225222|NCT02366689|BG000|Baseline|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
11225223|NCT02366689|BG001|Baseline|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
11225224|NCT02366689|BG002|Baseline|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
11225225|NCT02366689|BG003|Baseline|Total|Total of all reporting groups
11225226|NCT02366689|FG000|Participant Flow|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
11225227|NCT02366689|FG001|Participant Flow|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
11225228|NCT02366689|FG002|Participant Flow|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
11225229|NCT02366689|OG000|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
11225230|NCT02366689|OG001|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
11225231|NCT02366689|OG002|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
11225232|NCT02366689|EG000|Reported Event|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
11146814|NCT01854827|FG000|Participant Flow|IVIG Active Treatment|"Intravenous immunoglobulin (IVIG) 10% 1 gm/kg body weight/dose Day 3-5,30, 60 post HPE~Intravenous immunoglobulin (IVIG): All participants will receive the same dose of IVIG at the same intervals in an open-label fashion as long as the subject does not have any increased risk for toxicity for any IVIG infusion. IVIG will be initiated on day 3 (up to day 5) after HPE surgery (HPE is day 0) at a dose of 1 gm/kg body weight by slow intravenous infusion over at least 4 hours. The same dose (1 gm/kg) and duration of infusion will be repeated on day 30 and day 60 after HPE."
10880114|NCT00461500|OG000|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
10880115|NCT00461500|OG001|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
10880116|NCT00461500|EG000|Reported Event|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
10880117|NCT00461500|EG001|Reported Event|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
10880118|NCT00461513|BG000|Baseline|Intervention Group|Baseline characteristics of patients who enrolled and were randomized to the Intervention Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months). Therefore the total number completed in the Intervention Arm was 165, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 187 patients.
10880119|NCT00461513|BG001|Baseline|Usual Care Group|Baseline characteristics of patients who enrolled and were randomized to the Usual Care Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months).Therefore the total number completed in the Usual Care Arm was 172, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 197 patients.
10880120|NCT00461513|BG002|Baseline|Total|Total of all reporting groups
10880121|NCT00461513|FG000|Participant Flow|Intervention|The PCDM intervention included evaluation of CHF care by the collaborative care (CC) team with treatment recommendations based on current ACC/AHA clinical practice guidelines, telemonitoring, and screening and treatment for comorbid depression. The CC team at each site included a primary care provider, cardiologist and psychiatrist, as well as nurse and pharmacist. For each intervention patient, there was initial assessment of care following the enrollment visit. Each intervention patient was re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months). In addition, patients had daily telemonitoring, and their care was reviewed if the telemonitoring data suggested clinical deterioration.
11146815|NCT01854827|OG000|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
11146816|NCT01854827|EG000|Reported Event|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
10880122|NCT00461513|FG001|Participant Flow|Usual Care|Patients randomized to the usual care arm continued to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment. Patients in the usual care group were given information sheets that outlined self-care for CHF, and provided with a scale if needed at the enrollment visit. Patients in the usual care group had the same amount of interaction with the study team as the intervention patients (i.e. complete questionnaires at the same frequency; have the same study visits). PCPs of usual care patients were notified of the results of all screening studies (patient survey results, lab tests).
10880123|NCT00461513|OG000|Outcome|Intervention|
10880124|NCT00461513|OG001|Outcome|Usual Care|
10880125|NCT00461513|OG000|Outcome|Intervention|one-year mortality among intervention patients
10880126|NCT00461513|OG001|Outcome|Usual Care|one-year mortality among usual care patients
10880127|NCT00461513|OG000|Outcome|Intervention|one-year hospitalization among intervention patients
10880128|NCT00461513|OG001|Outcome|Usual Care|one year hospitalization among usual care patients
10880129|NCT00461513|EG000|Reported Event|Intervention|
10880130|NCT00461513|EG001|Reported Event|Usual Care|
10880131|NCT00461552|BG000|Baseline|Leptin|Randomized to receive leptin.
10880132|NCT00461552|BG001|Baseline|Placebo|Randomized to receive placebo.
10880133|NCT00461552|BG002|Baseline|Total|Total of all reporting groups
10880134|NCT00461552|FG000|Participant Flow|Leptin|Randomized to receive leptin.
10880135|NCT00461552|FG001|Participant Flow|Placebo|Randomized to receive placebo
10880136|NCT00461552|OG000|Outcome|Leptin|Randomized to receive leptin.
10880137|NCT00461552|OG001|Outcome|Placebo|Randomized to receive placebo.
10880138|NCT00461552|EG000|Reported Event|Leptin|Randomized to receive leptin.
10880139|NCT00461552|EG001|Reported Event|Placebo|Randomized to receive placebo.
10880140|NCT00461591|BG000|Baseline|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
10880141|NCT00461591|BG001|Baseline|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
10880142|NCT00461591|BG002|Baseline|Total|Total of all reporting groups
10880143|NCT00461591|FG000|Participant Flow|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
10880144|NCT00461591|FG001|Participant Flow|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
10880145|NCT00461591|OG000|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
10880146|NCT00461591|OG001|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
10880147|NCT00461591|EG000|Reported Event|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
10880148|NCT00461591|EG001|Reported Event|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
10880149|NCT00461630|BG000|Baseline|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
10880150|NCT00461630|BG001|Baseline|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
10880151|NCT00461630|BG002|Baseline|Total|Total of all reporting groups
11146817|NCT01854879|BG000|Baseline|Nucleus 6|Nucleus 6 sound processor
11146818|NCT01854879|FG000|Participant Flow|Nucleus 6|Nucleus 6 sound processor
11146819|NCT01854879|OG000|Outcome|Nucleus 6|Nucleus 6 sound processor
11146820|NCT01854879|EG000|Reported Event|Nucleus 6|Nucleus 6 sound processor
11146821|NCT01854905|BG000|Baseline|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
11146822|NCT01854905|FG000|Participant Flow|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
11146823|NCT01854905|OG000|Outcome|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
11146824|NCT01854905|EG000|Reported Event|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
11146825|NCT01854918|BG000|Baseline|Standard of Care|Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
11146826|NCT01854918|BG001|Baseline|Evolocumab + Standard of Care|Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
11146827|NCT01854918|BG002|Baseline|Total|Total of all reporting groups
11146828|NCT01854918|FG000|Participant Flow|Standard of Care|Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
11146829|NCT01854918|FG001|Participant Flow|Evolocumab + Standard of Care|Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
10880152|NCT00461630|FG000|Participant Flow|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
11146830|NCT01854918|OG000|Outcome|Year 1: Standard of Care|Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).
11146831|NCT01854918|OG001|Outcome|Year 1: Evolocumab + Standard of Care|Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
11146832|NCT01854918|OG002|Outcome|Years 2-3: SOC / Evolocumab + SOC|At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.
11146833|NCT01854918|OG003|Outcome|Years 2-3: Evolocumab + SOC / Evolocumab + SOC|Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.
11146834|NCT01854918|OG000|Outcome|Standard of Care|Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
11146835|NCT01854918|OG001|Outcome|Evolocumab + Standard of Care|Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
11146836|NCT01854918|EG000|Reported Event|Year 1: Standard of Care|Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).
11146837|NCT01854918|EG001|Reported Event|Year 1: Evolocumab + Standard of Care|Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
11146838|NCT01854918|EG002|Reported Event|Years 2-3: SOC / Evolocumab + SOC|At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.
11146839|NCT01854918|EG003|Reported Event|Years 2-3: Evolocumab + SOC / Evolocumab + SOC|Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.
11146840|NCT01854918|EG004|Reported Event|Years 2-3: Total|All participants in the All-IP period who received evolocumab plus SOC for approximately 2 years. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.
11146841|NCT01854944|BG000|Baseline|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146842|NCT01854944|BG001|Baseline|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
11146843|NCT01854944|BG002|Baseline|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146844|NCT01854944|BG003|Baseline|Total|Total of all reporting groups
11146845|NCT01854944|FG000|Participant Flow|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1 milligram (mg) tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146846|NCT01854944|FG001|Participant Flow|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
11146847|NCT01854944|FG002|Participant Flow|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146848|NCT01854944|OG000|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
10880153|NCT00461630|FG001|Participant Flow|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
10880154|NCT00461630|OG000|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
10880155|NCT00461630|OG001|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
10880156|NCT00461630|EG000|Reported Event|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
10880157|NCT00461630|EG001|Reported Event|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
10880158|NCT00461708|BG000|Baseline|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880159|NCT00461708|BG001|Baseline|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880160|NCT00461708|BG002|Baseline|Total|Total of all reporting groups
10880161|NCT00461708|FG000|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2|Participants with a rash Grade < 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (V) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880162|NCT00461708|FG001|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880163|NCT00461708|OG000|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880164|NCT00461708|OG001|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880165|NCT00461708|OG000|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880166|NCT00461708|OG001|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880167|NCT00461708|OG002|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880168|NCT00461708|EG000|Reported Event|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
11146849|NCT01854944|OG001|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
10880169|NCT00461708|EG001|Reported Event|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
10880170|NCT00461734|BG000|Baseline|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
10880171|NCT00461734|BG001|Baseline|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
10880172|NCT00461734|BG002|Baseline|Total|Total of all reporting groups
10880173|NCT00461734|FG000|Participant Flow|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
10880174|NCT00461734|FG001|Participant Flow|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
10880175|NCT00461734|OG000|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
10880176|NCT00461734|OG001|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
10880177|NCT00461734|OG000|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
10880178|NCT00461734|OG001|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
10880179|NCT00461734|OG000|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
10880180|NCT00461734|OG001|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
11146850|NCT01854944|OG000|Outcome|Brexpiprazole 4mg|Participants received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146851|NCT01854944|OG000|Outcome|Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
10880181|NCT00461734|OG001|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to trat cohort)
10880182|NCT00461734|EG000|Reported Event|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
10880183|NCT00461734|EG001|Reported Event|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
10880184|NCT00461773|BG000|Baseline|Bevacizumab|brief exposure bevacizumab
10880185|NCT00461773|BG001|Baseline|Bevacizumab and Letrozole|brief exposure bevacizumab and letrozole
10880186|NCT00461773|BG002|Baseline|Total|Total of all reporting groups
10880187|NCT00461773|FG000|Participant Flow|Bevacizumab|"brief exposure bevacizumab~Bevacizumab: bevacizumab 10 mg/kg IV"
10880188|NCT00461773|FG001|Participant Flow|Bevacizumab and Letrozole|"brief exposure bevacizumab and letrozole~Letrozole: Letrozole 2.5 mg once orally daily~Bevacizumab: bevacizumab 10 mg/kg IV"
10880189|NCT00461773|OG000|Outcome|Bevacizumab|brief exposure bevacizumab
10880190|NCT00461773|OG001|Outcome|Bevacizumab and Letrozole|brief exposure bevacizumab and letrozole
10880191|NCT00461773|EG000|Reported Event|Bevacizumab|brief exposure bevacizumab
10880192|NCT00461773|EG001|Reported Event|Bevacizumab and Letrozole|brief exposure bevacizumab and letrozole
10880193|NCT00461786|BG000|Baseline|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
10880194|NCT00461786|FG000|Participant Flow|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
10880195|NCT00461786|OG000|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
10880196|NCT00461786|EG000|Reported Event|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
10880197|NCT00461851|BG000|Baseline|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
10880198|NCT00461851|FG000|Participant Flow|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
10880199|NCT00461851|OG000|Outcome|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
10880200|NCT00461851|EG000|Reported Event|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
10880201|NCT00461981|BG000|Baseline|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
10880202|NCT00461981|BG001|Baseline|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
10880203|NCT00461981|BG002|Baseline|Total|Total of all reporting groups
10880204|NCT00461981|FG000|Participant Flow|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
10880205|NCT00461981|FG001|Participant Flow|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
10880206|NCT00461981|OG000|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
10880207|NCT00461981|OG001|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
10880208|NCT00461981|EG000|Reported Event|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
10880209|NCT00461981|EG001|Reported Event|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
10880210|NCT00462020|BG000|Baseline|IV Only|5 days of IV antibiotics after appendectomy
10880211|NCT00462020|BG001|Baseline|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
10880212|NCT00462020|BG002|Baseline|Total|Total of all reporting groups
10880213|NCT00462020|FG000|Participant Flow|IV Only|5 days of IV antibiotics after appendectomy
10880214|NCT00462020|FG001|Participant Flow|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment
10880215|NCT00462020|OG000|Outcome|IV Only|5 days of IV antibiotics after appendectomy
10880216|NCT00462020|OG001|Outcome|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
10880217|NCT00462020|EG000|Reported Event|IV Only|5 days of IV antibiotics after appendectomy
10880218|NCT00462020|EG001|Reported Event|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
10880219|NCT00462072|BG000|Baseline|Rheumatoid Arthritis (RA)|RA subject starting Infliximab
10880220|NCT00462072|BG001|Baseline|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab
10880221|NCT00462072|BG002|Baseline|Psoriasis (Ps)|Ps subjects starting Infliximab
10880222|NCT00462072|BG003|Baseline|Total|Total of all reporting groups
10880223|NCT00462072|FG000|Participant Flow|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
10880224|NCT00462072|FG001|Participant Flow|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
10880225|NCT00462072|FG002|Participant Flow|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
10880226|NCT00462072|OG000|Outcome|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab as part of their standard of care.
10880227|NCT00462072|OG001|Outcome|Rheumatoid Arthritis (RA)|RA subjects starting Infliximab as part of their standard of care.
10880228|NCT00462072|OG000|Outcome|Psoriariatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
10880229|NCT00462072|OG001|Outcome|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
10880230|NCT00462072|OG000|Outcome|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
10880231|NCT00462072|OG001|Outcome|Rheumatoid Arthritis|RA subjects taking Infliximab as part of their standard of care.
10880232|NCT00462072|OG000|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
10880233|NCT00462072|EG000|Reported Event|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
10880234|NCT00462072|EG001|Reported Event|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
10880235|NCT00462072|EG002|Reported Event|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
10880236|NCT00462124|BG000|Baseline|Balloon Implant|Implantation of a biodegradable balloon spacer (absorbable perirectal spacer) to increase the distance between prostate and anterior rectal wali.
10880237|NCT00462124|FG000|Participant Flow|Balloon Implant|Absorbable perirectal spacer implantation
10880238|NCT00462124|OG000|Outcome|Balloon Implant|Absorbable perirectal spacer implantation
10880239|NCT00462124|OG000|Outcome|Balloon Implant|Implantation of a biodegradable balloon spacer (absorbable perirectal spacer) to increase the distance between prostate and anterior rectal wali.
10880240|NCT00462124|EG000|Reported Event|Group 1|Absorbable perirectal spacer implantation
10880241|NCT00462228|BG000|Baseline|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design.
10880242|NCT00462228|FG000|Participant Flow|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design. Five subjects were randomized to begin the study by taking memantine and crossover to placebo; seven subjects began with placebo and crossed over to memantine.
10880243|NCT00462228|OG000|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
10880244|NCT00462228|OG001|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
10880245|NCT00462228|EG000|Reported Event|Placebo|All 11 subjects completed 12 weeks of placebo treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
10880246|NCT00462228|EG001|Reported Event|Memantine|All 11 subjects completed 12 weeks of memantine treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
10880247|NCT00462228|EG002|Reported Event|No Treatment (Washout)|All 11 subjects completed a 4 week washout between memantine and placebo arms and a 4 week washout at the end of the study.
10880248|NCT00462280|BG000|Baseline|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
11146852|NCT01854944|OG000|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in Cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146853|NCT01854944|OG001|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in Cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
11146854|NCT01854944|OG002|Outcome|Cohort 3 - Brexpiprazole 4 mg|Participants in Cohort 3 received one 1- to 4-mg dose of brexpiprazole (at the investigator's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
10880249|NCT00462280|BG001|Baseline|Two Matched Nevi Group-Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880250|NCT00462280|BG002|Baseline|One Large Nevi Group-Lovastatin|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880251|NCT00462280|BG003|Baseline|One Large Nevi Group-Placebo|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880252|NCT00462280|BG004|Baseline|Total|Total of all reporting groups
10880253|NCT00462280|FG000|Participant Flow|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880254|NCT00462280|FG001|Participant Flow|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880255|NCT00462280|FG002|Participant Flow|One Large Nevi Group - Lovastatin|"Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880256|NCT00462280|FG003|Participant Flow|One Large Nevi Group - Placebo|"Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
11146855|NCT01854944|OG000|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
10880257|NCT00462280|OG000|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880258|NCT00462280|OG001|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880259|NCT00462280|OG000|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
11146856|NCT01854944|OG001|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
11146857|NCT01854944|OG002|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146858|NCT01854944|OG000|Outcome|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146859|NCT01854944|OG001|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
11146860|NCT01854944|OG002|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146861|NCT01854944|OG001|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
11146862|NCT01854944|OG002|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146863|NCT01854944|OG001|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
11146864|NCT01854944|OG002|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146865|NCT01854944|EG000|Reported Event|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received one 1-mg of brexpiprazole once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146866|NCT01854944|EG001|Reported Event|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
10880260|NCT00462280|OG001|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880261|NCT00462280|OG000|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm.~Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880262|NCT00462280|OG001|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880263|NCT00462280|EG000|Reported Event|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
11150063|NCT01875367|OG002|Outcome|Boths Arms: Subcutaneous-Trastuzumab Device (SC-t SID)|Patients from both arms (A and B) who received Single injection device
11150064|NCT01875367|EG000|Reported Event|Arm A: T-IV + T-SC Vial + T-SC Device|Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.
11150065|NCT01875367|EG001|Reported Event|Arm B: T-IV + T-SC Device + T-SC Vial|Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
11150066|NCT01875445|BG000|Baseline|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
11146867|NCT01854944|EG002|Reported Event|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
11146868|NCT01855048|BG000|Baseline|N-Rephasin® SAL200 0.1(mg/kg)|"N-Rephasin® SAL200, 0.1 mg/kg~N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes"
11146869|NCT01855048|BG001|Baseline|N-Rephasin® SAL200 0.3(mg/kg)|"N-Rephasin® SAL200, 0.3 mg/kg~N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes"
11146870|NCT01855048|BG002|Baseline|N-Rephasin® SAL200 1(mg/kg)|"N-Rephasin® SAL200,~1 mg/kg~N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes"
11146871|NCT01855048|BG003|Baseline|N-Rephasin® SAL200 3(mg/kg)|"N-Rephasin® SAL200, 3 mg/kg~N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes"
11146872|NCT01855048|BG004|Baseline|N-Rephasin® SAL200 10(mg/kg)|"N-Rephasin® SAL200, 10 mg/kg~N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes"
11146873|NCT01855048|BG005|Baseline|INT200-Placebo|"Placebo~INT200-Placebo: Formulation buffer for continuous intravenous infusion over 60 minutes"
11146874|NCT01855048|BG006|Baseline|Total|Total of all reporting groups
11146875|NCT01855048|FG000|Participant Flow|INT200-Placebo|"Placebo~INT200-Placebo: Formulation buffer for continuous intravenous infusion over 60 minutes"
11146876|NCT01855048|FG001|Participant Flow|N-Rephasin® SAL200, 0.1mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
11146877|NCT01855048|FG002|Participant Flow|N-Rephasin® SAL200, 0.3 mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
11146878|NCT01855048|FG003|Participant Flow|N-Rephasin® SAL200, 1 mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
11146879|NCT01855048|FG004|Participant Flow|N-Rephasin® SAL200, 3 mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
10880264|NCT00462280|EG001|Reported Event|Two Matched Nevi Group-Placebo|"Patients receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
10880265|NCT00462280|EG002|Reported Event|One Large Nevi Group-Lovastatin|Patients who have one large nevi received lovastatin PO QD for up to 6 months
10880266|NCT00462280|EG003|Reported Event|One Large Nevi Group-Placebo|Patients who have one large nevi receive placebo PO QD for up to 6 months
10880267|NCT00462306|BG000|Baseline|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
10880268|NCT00462306|BG001|Baseline|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
10880269|NCT00462306|BG002|Baseline|Total|Total of all reporting groups
10880270|NCT00462306|FG000|Participant Flow|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
10880271|NCT00462306|FG001|Participant Flow|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
10880272|NCT00462306|OG000|Outcome|Pregnant Women|
10880273|NCT00462306|OG001|Outcome|Non-Pregnant Women|Non-pregnant women undergoing a surgical procedure
10880274|NCT00462306|OG000|Outcome|Positive Berlin Questionaires|Pregnant Women with Berlin Questionnaire Responses Indicative of Sleep Disordered Breathing
10880275|NCT00462306|OG001|Outcome|Negative Berlin Questionnaires|Pregnant Women with Results of Berlin Questionnaire not Indicative of Sleep Disordered Breathing
10880276|NCT00462306|EG000|Reported Event|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
11009733|NCT01103934|OG001|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
11146880|NCT01855048|FG005|Participant Flow|N-Rephasin® SAL200, 10 mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
10880277|NCT00462306|EG001|Reported Event|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
10880278|NCT00462332|BG000|Baseline|High Risk Patientes|Category of risk will be defined according to biological features.
10880279|NCT00462332|BG001|Baseline|Low Risk Patients|Category of risk will be defined according to biological features.
10880280|NCT00462332|BG002|Baseline|Total|Total of all reporting groups
10880281|NCT00462332|FG000|Participant Flow|High Risk Patientes|Category of risk will be defined according to biological features.
10880282|NCT00462332|FG001|Participant Flow|Low Risk Patients|Category of risk will be defined according to biological features.
10880283|NCT00462332|OG000|Outcome|Low Risk Patients|
10880284|NCT00462332|OG001|Outcome|High Risk Patients|
10880285|NCT00462332|OG000|Outcome|High Risk Patientes|Category of risk will be defined according to biological features.
10880286|NCT00462332|OG001|Outcome|Low Risk Patients|Category of risk will be defined according to biological features.
10880287|NCT00462332|EG000|Reported Event|High Risk Patientes|Category of risk will be defined according to biological features.
10880288|NCT00462332|EG001|Reported Event|Low Risk Patients|Category of risk will be defined according to biological features.
10880289|NCT00462345|BG000|Baseline|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
10880290|NCT00462345|FG000|Participant Flow|Rituximab, Methotrexate|Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate at a stable dose of greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
10880291|NCT00462345|OG000|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
10880292|NCT00462345|EG000|Reported Event|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
11009734|NCT01103934|EG000|Reported Event|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
11146881|NCT01855048|OG000|Outcome|Placebo|INT200-Placebo, IV administration
11146882|NCT01855048|OG001|Outcome|N-Rephasin® SAL200 (0.1 mg/kg)|Study drug 0.0056 mL/kg, IV administration
11146883|NCT01855048|OG002|Outcome|N-Rephasin® SAL200 (0.3 mg/kg)|Study drug 0.017 mL/kg, IV administration
11146884|NCT01855048|OG003|Outcome|N-Rephasin® SAL200 (1 mg/kg)|Study drug 0.056 mL/kg, IV administration
11146885|NCT01855048|OG004|Outcome|N-Rephasin® SAL200 (3 mg/kg)|Study drug 0.167 mL/kg, IV administration
11146886|NCT01855048|OG005|Outcome|N-Rephasin® SAL200 (10 mg/kg)|Study drug 0.556 mL/kg, IV administration
11146887|NCT01855048|OG000|Outcome|N-Rephasin® SAL200 0.1mg/kg|Study drug 0.0056 mL/kg, IV administration
11146888|NCT01855048|OG001|Outcome|N-Rephasin® SAL200 0.3mg/kg|Study drug 0.017 mL/kg, IV administration
11146889|NCT01855048|OG002|Outcome|N-Rephasin® SAL200 1mg/kg|Study drug 0.056 mL/kg, IV administration
11146890|NCT01855048|OG003|Outcome|N-Rephasin® SAL200 3mg/kg|Study drug 0.167 mL/kg, IV administration
11146891|NCT01855048|OG004|Outcome|N-Rephasin® SAL200 10mg/kg|Study drug 0.556 mL/kg, IV administration
11146892|NCT01855048|OG000|Outcome|N-Rephasin® SAL200 0.1 mg/kg|Study drug 0.0056 mL/kg, IV administration
11146893|NCT01855048|OG001|Outcome|N-Rephasin® SAL200 0.3 mg/kg|Study drug 0.017 mL/kg, IV administration
11146894|NCT01855048|OG002|Outcome|N-Rephasin® SAL200 1 mg/kg|Study drug 0.056 mL/kg, IV administration
11146895|NCT01855048|OG003|Outcome|N-Rephasin® SAL200 3 mg/kg|Study drug 0.167 mL/kg, IV administration
10880293|NCT00462384|BG000|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
10880294|NCT00462384|FG000|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
10880295|NCT00462384|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
10880296|NCT00462384|EG000|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
10880297|NCT00462423|BG000|Baseline|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
10880298|NCT00462423|FG000|Participant Flow|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
10880299|NCT00462423|OG000|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
10880300|NCT00462423|OG000|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).~Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
10880301|NCT00462423|EG000|Reported Event|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
10880302|NCT00462449|BG000|Baseline|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
10880303|NCT00462449|BG001|Baseline|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
10880304|NCT00462449|BG002|Baseline|Total|Total of all reporting groups
10880305|NCT00462449|FG000|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
10880306|NCT00462449|FG001|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
11146896|NCT01855048|OG004|Outcome|N-Rephasin® SAL200 10 mg/kg|Study drug 0.556 mL/kg, IV administration
11146897|NCT01855048|EG000|Reported Event|INT200-Placebo|"Placebo~INT200-Placebo: Formulation buffer for continuous intravenous infusion over 60 minutes"
11146898|NCT01855048|EG001|Reported Event|N-Rephasin® SAL200, 0.1mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
11146899|NCT01855048|EG002|Reported Event|N-Rephasin® SAL200, 0.3 mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
11146900|NCT01855048|EG003|Reported Event|N-Rephasin® SAL200, 1 mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
11146901|NCT01855048|EG004|Reported Event|N-Rephasin® SAL200, 3 mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
10880307|NCT00462449|OG000|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
10880308|NCT00462449|OG001|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
10880309|NCT00462449|EG000|Reported Event|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
11146902|NCT01855048|EG005|Reported Event|N-Rephasin® SAL200, 10 mg/kg|N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
11146903|NCT01855074|BG000|Baseline|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
11146904|NCT01855074|FG000|Participant Flow|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
11146905|NCT01855074|OG000|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
11146906|NCT01855074|EG000|Reported Event|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
11146907|NCT01855126|BG000|Baseline|Active Intervention, Then Placebo Intervention|Participants started the study by wearing the blue mask every night for 8 weeks. After a washout period of 2 weeks, participants wore the red mask every night for 8 weeks
11146908|NCT01855126|BG001|Baseline|Placebo Intervention, Then Active Intervention|Participants started the study by wearing the red mask every night for 8 weeks. After a washout period of 2 weeks, participants wore the blue mask every night for 8 weeks.
11146909|NCT01855126|BG002|Baseline|Total|Total of all reporting groups
11146910|NCT01855126|FG000|Participant Flow|Active Intervention, Then Placebo|Participants started the study wearing the blue mask for 8 weeks. After a 2 week washout period, they wore the red mask for 8 weeks
11146911|NCT01855126|FG001|Participant Flow|Placebo Intervention, Then Active|Participants started the study wearing the red mask every night for 8 weeks. After a 2 week washout period, they wore the blue mask every night for 8 weeks.
11146912|NCT01855126|OG000|Outcome|Blue Light Mask|Participants wore the blue mask every night for 8 weeks.
10880310|NCT00462449|EG001|Reported Event|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
10880311|NCT00462462|BG000|Baseline|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
10880312|NCT00462462|BG001|Baseline|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
10880313|NCT00462462|BG002|Baseline|Total|Total of all reporting groups
10880314|NCT00462462|FG000|Participant Flow|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
10880315|NCT00462462|FG001|Participant Flow|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
10880316|NCT00462462|OG000|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and who had blood samples just before and during infusion procedure.
10880317|NCT00462462|OG001|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and who had blood samples just before and during infusion procedure (one patient who received Absolute Ethanol was not sampled during infusion procedure).
10880318|NCT00462462|OG000|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and for whom lesional volume measurements were available at screening and at study end
10880319|NCT00462462|OG001|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and for whom lesional volume measurements were available at screening and at study end
10880320|NCT00462462|EG000|Reported Event|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
10880321|NCT00462462|EG001|Reported Event|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
10880322|NCT00462488|BG000|Baseline|Treatment Schedule A -|"Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.~If the subject had histologically confirmed disease that is stage <T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study [EOS]).~Vicinium: Intravesical administration of Vicinium"
10880323|NCT00462488|BG001|Baseline|Treatment Schedule B|"Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.~If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).~Vicinium: Intravesical administration of Vicinium"
10880324|NCT00462488|BG002|Baseline|Total|Total of all reporting groups
10880325|NCT00462488|FG000|Participant Flow|Treatment Schedule A -|"Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.~If the subject had histologically confirmed disease that is stage <T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study [EOS]).~Vicinium: Intravesical administration of Vicinium"
10880326|NCT00462488|FG001|Participant Flow|Treatment Schedule B|"Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.~If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).~Vicinium: Intravesical administration of Vicinium"
10880327|NCT00462488|OG000|Outcome|Treatment Schedule A -|"Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.~If the subject had histologically confirmed disease that is stage <T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study [EOS]).~Vicinium: Intravesical administration of Vicinium"
10880328|NCT00462488|OG001|Outcome|Treatment Schedule B|"Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.~If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).~Vicinium: Intravesical administration of Vicinium"
10887294|NCT00499655|BG000|Baseline|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
11146913|NCT01855126|OG001|Outcome|Red Light Mask|Participants wore the red mask every night for 8 weeks.
10880329|NCT00462488|EG000|Reported Event|Treatment Schedule A -|"Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.~If the subject had histologically confirmed disease that is stage <T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study [EOS]).~Vicinium: Intravesical administration of Vicinium"
10880330|NCT00462488|EG001|Reported Event|Treatment Schedule B|"Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.~If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).~Vicinium: Intravesical administration of Vicinium"
10880331|NCT00462501|BG000|Baseline|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
10880332|NCT00462501|FG000|Participant Flow|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
10880333|NCT00462501|OG000|Outcome|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
10880334|NCT00462501|EG000|Reported Event|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
11009735|NCT01103934|EG001|Reported Event|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
11009736|NCT01103960|BG000|Baseline|A5 Alone|Amlodipine 5mg monotherapy
11146914|NCT01855126|OG000|Outcome|Blue Light Mask|Participants started the study wearing the blue light mask every night for 8 weeks.
11146915|NCT01855126|OG001|Outcome|Red Light Mask|Participants started the study wearing the red light mask for 8 weeks.
11146916|NCT01855126|OG000|Outcome|Blue Light Mask|Participants started the study wearing the blue mask for 8 weeks.
11146917|NCT01855126|OG001|Outcome|Red Light Mask|Participants started the study wearing the red mask every night for 8 weeks.
11146918|NCT01855126|EG000|Reported Event|Blue Light|This within-subjects, randomized, two-treatment crossover design study consists of two 8-week periods in which each participant wore either the intervention (blue light) or control (red light) mask every night. Subjects will use each condition for eight weeks, with the intervention order counterbalanced across subjects, and a two-week washout period between the two study conditions. The blue mask delivered a flashing blue light for two hours beginning 1 hour after bedtime designed to result in a phase delay of the circadian response curve.
11150067|NCT01875445|BG001|Baseline|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
11150068|NCT01875445|BG002|Baseline|Total|Total of all reporting groups
10880335|NCT00462605|BG000|Baseline|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
10880336|NCT00462605|FG000|Participant Flow|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
10880337|NCT00462605|OG000|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
10880338|NCT00462605|EG000|Reported Event|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
10880339|NCT00462644|BG000|Baseline|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
10880340|NCT00462644|BG001|Baseline|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
11009737|NCT01103960|BG001|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11009738|NCT01103960|BG002|Baseline|Total|Total of all reporting groups
11146919|NCT01855126|EG001|Reported Event|Red Light|This within-subjects, randomized, two-treatment crossover design study consists of two 8-week periods in which each participant wore either the intervention (blue light) or control (red light) mask every night. Subjects will use each condition for eight weeks, with the intervention order counterbalanced across subjects, and a two-week washout period between the two study conditions. The red mask delivered a flashing red light for two hours beginning 1 hour after bedtime designed to have no effect on the circadian response curve.
11009739|NCT01103960|FG000|Participant Flow|A5 Alone|Amlodipine 5mg monotherapy
11009740|NCT01103960|FG001|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11146920|NCT01855243|BG000|Baseline|Glargine Plus Supplemental Glulisine|"Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held.~Glargine~glulisine"
10880341|NCT00462644|BG002|Baseline|Total|Total of all reporting groups
10880342|NCT00462644|FG000|Participant Flow|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
11009741|NCT01103960|OG000|Outcome|A5 Alone|Amlodipine 5mg monotherapy
11009742|NCT01103960|OG001|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11009743|NCT01103960|EG000|Reported Event|A5 Alone|Amlodipine 5 mg one daily
11009744|NCT01103960|EG001|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
11009745|NCT01103973|BG000|Baseline|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
11009746|NCT01103973|BG001|Baseline|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
11009747|NCT01103973|BG002|Baseline|Total|Total of all reporting groups
11009748|NCT01103973|FG000|Participant Flow|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
11009749|NCT01103973|FG001|Participant Flow|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
11009750|NCT01103973|OG000|Outcome|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
11009751|NCT01103973|OG001|Outcome|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
11009752|NCT01103973|EG000|Reported Event|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
10880343|NCT00462644|FG001|Participant Flow|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
10880344|NCT00462644|OG000|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
10880345|NCT00462644|OG001|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
10880346|NCT00462644|EG000|Reported Event|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
10880347|NCT00462644|EG001|Reported Event|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
10880348|NCT00462670|BG000|Baseline|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
10880349|NCT00462670|BG001|Baseline|OPC-41061|15mg of OPC-41061 per day for 7days p.o. administration
10880350|NCT00462670|BG002|Baseline|Total|Total of all reporting groups
10880351|NCT00462670|FG000|Participant Flow|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
10880352|NCT00462670|FG001|Participant Flow|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
10880353|NCT00462670|OG000|Outcome|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
10880354|NCT00462670|OG001|Outcome|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
10880355|NCT00462670|EG000|Reported Event|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
10880356|NCT00462670|EG001|Reported Event|OPC-41061 15mg|15 mg of OPC-41061 per day for 7days p.o. administration
10880357|NCT00462709|BG000|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
10880358|NCT00462709|FG000|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV) every 3 to 7 days.
10880359|NCT00462709|OG000|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
10880360|NCT00462709|EG000|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
10880361|NCT00462722|BG000|Baseline|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880362|NCT00462722|BG001|Baseline|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880363|NCT00462722|BG002|Baseline|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880364|NCT00462722|BG003|Baseline|Total|Total of all reporting groups
10880365|NCT00462722|FG000|Participant Flow|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880366|NCT00462722|FG001|Participant Flow|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880367|NCT00462722|FG002|Participant Flow|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880368|NCT00462722|OG000|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880369|NCT00462722|OG001|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
11009753|NCT01103973|EG001|Reported Event|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
11150069|NCT01875445|FG000|Participant Flow|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
11146921|NCT01855243|BG001|Baseline|70/30 Insulin Plus Supplemental Lunch Insulin|"Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home.~regular insulin~70/30 insulin"
11146922|NCT01855243|BG002|Baseline|Sliding Scale Insulin (SSI)|"For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table~regular insulin"
11146923|NCT01855243|BG003|Baseline|Total|Total of all reporting groups
11150070|NCT01875445|FG001|Participant Flow|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
11066011|NCT01390818|BG008|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11150071|NCT01875445|OG000|Outcome|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
11009754|NCT01104025|BG000|Baseline|Induction Therapy|"ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42~ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours).~Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses.~Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients"
11150072|NCT01875445|OG001|Outcome|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
11009755|NCT01104025|FG000|Participant Flow|Induction Therapy|"ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42~ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours).~Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses.~Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients."
11150073|NCT01875445|EG000|Reported Event|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
10880370|NCT00462722|OG002|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880371|NCT00462722|EG000|Reported Event|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880372|NCT00462722|EG001|Reported Event|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880373|NCT00462722|EG002|Reported Event|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
10880374|NCT00462735|BG000|Baseline|Advanced Head and Neck Cancer|Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
10880375|NCT00462735|FG000|Participant Flow|Advanced Head and Neck Cancer|"Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck. Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.~Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.~Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients."
10880376|NCT00462735|OG000|Outcome|Advanced Head and Neck Cancer|Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
10880377|NCT00462735|OG000|Outcome|Advanced Head and Neck Cancer|Cetuximab - 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
10880378|NCT00462735|EG000|Reported Event|Advanced Head and Neck Cancer|Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
10880379|NCT00462761|BG000|Baseline|Quizartinib|"Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day.~Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule."
10880380|NCT00462761|FG000|Participant Flow|Quizartinib|"Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day.~Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule."
10880381|NCT00462761|OG000|Outcome|Quizartinib|"Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day.~Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule."
10880382|NCT00462761|OG000|Outcome|Quizartinib 12-135 mg ID|Participants received quizartinib (AC220) with doses ranging from 12-135 mg on an intermittent dosing (ID) schedule.
10880383|NCT00462761|OG001|Outcome|Quizartinib 200-450 mg ID|Participants received quizartinib (AC220) with doses ranging from 200-450 mg on an intermittent dosing (ID) schedule.
10880384|NCT00462761|OG002|Outcome|Quizartinib 200-300 mg CD|Participants received quizartinib (AC220) with doses ranging from 200-300 mg on a continuous dosing (CD) schedule.
11150074|NCT01875445|EG001|Reported Event|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
11150075|NCT01875471|BG000|Baseline|Delefilcon A|"Spherical daily disposable soft contact lens~delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
10880385|NCT00462761|OG003|Outcome|Total|All participants who received quizartinib, regardless of dosage or dosing schedule.
10880386|NCT00462761|OG000|Outcome|Quizartinib 12 mg ID|Participants received quizartinib (AC220) 12 mg/day on an intermittent dosing (ID) schedule.
10880387|NCT00462761|OG001|Outcome|Quizartinib 18 mg ID|Participants received quizartinib (AC220) 18 mg/day on an intermittent dosing (ID) schedule.
10880388|NCT00462761|OG002|Outcome|Quizartinib 27 mg ID|Participants received quizartinib (AC220) 27 mg/day on an intermittent dosing (ID) schedule.
10880389|NCT00462761|OG003|Outcome|Quizartinib 40 mg ID|Participants received quizartinib (AC220) 40 mg/day on an intermittent dosing (ID) schedule.
10880390|NCT00462761|OG004|Outcome|Quizartinib 60 mg ID|Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.
10880391|NCT00462761|OG005|Outcome|Quizartinib 90 mg ID|Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.
10880392|NCT00462761|OG006|Outcome|Quizartinib 135 mg ID|Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.
10880393|NCT00462761|OG007|Outcome|Quizartinib 200 mg ID|Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.
10880394|NCT00462761|OG008|Outcome|Quizartinib 300 mg ID|Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.
10880395|NCT00462761|OG009|Outcome|Quizartinib 450 mg ID|Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.
10880396|NCT00462761|OG010|Outcome|Quizartinib 200 mg CD|Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.
10880397|NCT00462761|OG011|Outcome|Quizartinib 300 mg CD|Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.
10880398|NCT00462761|OG012|Outcome|All Participants|All participants who received quizartinib, regardless of dosage and dosing schedule.
10880399|NCT00462761|EG000|Reported Event|Quizartinib 12 mg ID|Participants received quizartinib (AC220) 12 mg/day on an intermittent dosing (ID) schedule.
10880400|NCT00462761|EG001|Reported Event|Quizartinib 18 mg ID|Participants received quizartinib (AC220) 18 mg/day on an intermittent dosing (ID) schedule.
10880401|NCT00462761|EG002|Reported Event|Quizartinib 27 mg ID|Participants received quizartinib (AC220) 27 mg/day on an intermittent dosing (ID) schedule.
10880402|NCT00462761|EG003|Reported Event|Quizartinib 40 mg ID|Participants received quizartinib (AC220) 40 mg/day on an intermittent dosing (ID) schedule.
10880403|NCT00462761|EG004|Reported Event|Quizartinib 60 mg ID|Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.
10880404|NCT00462761|EG005|Reported Event|Quizartinib 90 mg ID|Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.
10880405|NCT00462761|EG006|Reported Event|Quizartinib 135 mg ID|Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.
10880406|NCT00462761|EG007|Reported Event|Quizartinib 200 mg ID|Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.
10880407|NCT00462761|EG008|Reported Event|Quizartinib 300 mg ID|Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.
10880408|NCT00462761|EG009|Reported Event|Quizartinib 450 mg ID|Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.
10880409|NCT00462761|EG010|Reported Event|Quizartinib 200 mg CD|Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.
10880410|NCT00462761|EG011|Reported Event|Quizartinib 300 mg CD|Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.
10880411|NCT00462826|BG000|Baseline|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10880412|NCT00462826|FG000|Participant Flow|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10880413|NCT00462826|OG000|Outcome|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10880414|NCT00462826|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10880415|NCT00462826|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10880416|NCT00462826|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10880417|NCT00462826|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10880418|NCT00462826|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10880419|NCT00462826|OG005|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10880420|NCT00462826|EG000|Reported Event|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10880421|NCT00462839|BG000|Baseline|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
10880422|NCT00462839|BG001|Baseline|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
10880423|NCT00462839|BG002|Baseline|Total|Total of all reporting groups
10880424|NCT00462839|FG000|Participant Flow|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
10880425|NCT00462839|FG001|Participant Flow|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
10880426|NCT00462839|OG000|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
10880427|NCT00462839|OG001|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
11146924|NCT01855243|FG000|Participant Flow|Glargine Plus Supplemental Glulisine|"Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held.~Glargine~glulisine"
10880428|NCT00462839|EG000|Reported Event|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
10880429|NCT00462839|EG001|Reported Event|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
10880430|NCT00462865|BG000|Baseline|Treatment|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
10880431|NCT00462865|FG000|Participant Flow|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
10880432|NCT00462865|OG000|Outcome|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles that lead to patients being taken off study.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
10880433|NCT00462865|EG000|Reported Event|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
10880434|NCT00462917|BG000|Baseline|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880435|NCT00462917|BG001|Baseline|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880436|NCT00462917|BG002|Baseline|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
10880437|NCT00462917|BG003|Baseline|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880438|NCT00462917|BG004|Baseline|Total|Total of all reporting groups
11146925|NCT01855243|FG001|Participant Flow|70/30 Insulin Plus Supplemental Lunch Insulin|"Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home.~regular insulin~70/30 insulin"
10880439|NCT00462917|FG000|Participant Flow|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880440|NCT00462917|FG001|Participant Flow|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880441|NCT00462917|FG002|Participant Flow|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
10880442|NCT00462917|FG003|Participant Flow|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880443|NCT00462917|OG000|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880444|NCT00462917|OG001|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880445|NCT00462917|OG002|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
10880446|NCT00462917|OG003|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880447|NCT00462917|EG000|Reported Event|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880448|NCT00462917|EG001|Reported Event|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880449|NCT00462917|EG002|Reported Event|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
11146926|NCT01855243|FG002|Participant Flow|Sliding Scale Insulin (SSI)|"For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table~regular insulin"
10880450|NCT00462917|EG003|Reported Event|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
10880451|NCT00462982|BG000|Baseline|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
10880452|NCT00462982|FG000|Participant Flow|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
10880453|NCT00462982|OG000|Outcome|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
10880454|NCT00462982|EG000|Reported Event|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
10880455|NCT00463047|BG000|Baseline|Total Number of Patients|Fentanyl Buccal Tablets (FBT) and Immediate-Release Oxycodone crossover. The total number of patients (323) reflect the number that were enrolled to participate in the study prior to the first titration period. Three subjects withdrew before receiving any study drug so they are not listed as being assigned to either dosing arm in the titration studies, leaving only 320 subjects who were evenly divided between the two groups.
10880456|NCT00463047|FG000|Participant Flow|FBT First Immediate Release Oxycodone Second|Patients were randomized 1:1 to titrate Fentanyl Buccal Tablet (FBT) during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
11348853|NCT04143373|FG000|Participant Flow|Room Temperature Saline of 25 ± 2 ° C|"In this study, during impacted mandibular third molar surgery, within each individual, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side of the same individual, was irrigated with normal saline of 37 ± 1 ° C as for the experimental side.~Within each individual, the left or right sides were allocated randomly for receiving these two types of saline."
11146927|NCT01855243|OG000|Outcome|Glargine Plus Supplemental Glulisine|"Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held.~Glargine~glulisine"
11150076|NCT01875471|BG001|Baseline|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking~narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
11150077|NCT01875471|BG002|Baseline|Total|Total of all reporting groups
11150078|NCT01875471|FG000|Participant Flow|Delefilcon A|Spherical daily disposable soft contact lens
11150079|NCT01875471|FG001|Participant Flow|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
10880457|NCT00463047|FG001|Participant Flow|Immediate-Release Oxycodone First FBT Second|Patients were randomly assigned 1:1 to either titrate FBT during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
10880458|NCT00463047|OG000|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
10880459|NCT00463047|OG001|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
10880460|NCT00463047|OG000|Outcome|Total|Includes all patients who participated in the double-blind treatment period and completed treatment.
10880461|NCT00463047|EG000|Reported Event|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients. This group includes all subjects in this study who had taken at least one dose of FBT in the course of the study, including both titration periods and both double-blind treatment periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
10880462|NCT00463047|EG001|Reported Event|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug. This arm represents all subjects who had exposure to at least one dose of immediate-release oxycodone either during the titration periods or double-blind periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
11146928|NCT01855243|OG001|Outcome|70/30 Insulin Plus Supplemental Lunch Insulin|"Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home.~regular insulin~70/30 insulin"
11146929|NCT01855243|OG002|Outcome|Sliding Scale Insulin (SSI)|"For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table~regular insulin"
11146930|NCT01855243|EG000|Reported Event|Glargine Plus Supplemental Glulisine|"Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held.~Glargine~glulisine"
11146931|NCT01855243|EG001|Reported Event|70/30 Insulin Plus Supplemental Lunch Insulin|"Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home.~regular insulin~70/30 insulin"
11146932|NCT01855243|EG002|Reported Event|Sliding Scale Insulin (SSI)|"For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table~regular insulin"
11150080|NCT01875471|OG000|Outcome|Delefilcon A|Spherical daily disposable soft contact lens
10880463|NCT00463060|BG000|Baseline|Phase I|N=21 participants Patients enrolled between Feb 2007 and May 2008
10880464|NCT00463060|BG001|Baseline|Phase II Advanced Solid Tumor Malignancy|"Patients were eligible if they had histologically or cytological documented advanced solid tumor malignancy with radiographic evidence of 1 to 5 sites of active metastatic disease.~N=26 participants Patients enrolled between February 2008 and September 2010"
10880465|NCT00463060|BG002|Baseline|Total|Total of all reporting groups
10880466|NCT00463060|FG000|Participant Flow|Advanced Solid Tumor Malignancy|Patients were eligible if they had histologically or cytological documented advanced solid tumor malignancy with radiographic evidence of 1 to 5 sites of active metastatic disease.
10880467|NCT00463060|OG000|Outcome|Phase 1 - Radiation 40Gy + Sunitinib 25 mg|
10880468|NCT00463060|OG001|Outcome|Phase 1 - Radiation 40Gy + Suniitnib 37.5 mg|
10880469|NCT00463060|OG002|Outcome|Phase 1 - Radiation 50Gy + Sunitinib 37.5mg|
10880470|NCT00463060|OG003|Outcome|Phase 1 - Radiation 50Gy + Sunitinib 50mg|
10880471|NCT00463060|OG000|Outcome|Advanced Solid Tumor Malignancy|Patients were eligible if they had histologically or cytological documented advanced solid tumor malignancy with radiographic evidence of 1 to 5 sites of active metastatic disease.
10880472|NCT00463060|EG000|Reported Event|Phase 1|N=21 participants Patients enrolled between Feb 2007 and May 2008
10880473|NCT00463060|EG001|Reported Event|Phase 2|"Patients were eligible if they had histologically or cytological documented advanced solid tumor malignancy with radiographic evidence of 1 to 5 sites of active metastatic disease.~N=26 participants Patients enrolled between February 2008 and September 2010"
10880474|NCT00463151|BG000|Baseline|Rebamipide 60 mg|Once daily intracolonial administration at a dose of 60 mg for 6 weeks
10880475|NCT00463151|BG001|Baseline|Rebamipide 150 mg|Once daily intracolonial administration at a dose of 150 mg for 6 weeks
10880476|NCT00463151|BG002|Baseline|Rebamipide 300 mg|Once daily intracolonial administration at a dose of 300 mg for 6 weeks
10880477|NCT00463151|BG003|Baseline|Placebo|Once daily intracolonial administration of placebo for 6 weeks
11146933|NCT01855360|BG000|Baseline|TUDCA and Doxycycline|"INTERVENTION: Patients meeting study criteria were prescribed TUDCA taken orally, 250 mg three times daily. and doxycycline taken orally, 100 mg twice daily.~Tauroursodeoxycholic Acid and Doxycycline"
11146934|NCT01855360|FG000|Participant Flow|TUDCA and Doxycycline|"INTERVENTION: Patients meeting study criteria were prescribed TUDCA taken orally, 250 mg three times daily. and doxycycline taken orally, 100 mg twice daily.~Tauroursodeoxycholic Acid and Doxycycline"
10880478|NCT00463151|BG004|Baseline|Total|Total of all reporting groups
10880479|NCT00463151|FG000|Participant Flow|Rebamipide 60 mg|Once daily intracolonial administration at a dose of 60 mg for 6 weeks
10880480|NCT00463151|FG001|Participant Flow|Rebamipide 150 mg|Once daily intracolonial administration at a dose of 150 mg for 6 weeks
10880481|NCT00463151|FG002|Participant Flow|Rebamipide 300 mg|Once daily intracolonial administration at a dose of 300 mg for 6 weeks
10880482|NCT00463151|FG003|Participant Flow|Placebo|Once daily intracolonial administration of placebo for 6 weeks
10880483|NCT00463151|OG000|Outcome|Rebamipide 60 mg|Once daily intracolonial administration at a dose of 60 mg for 6 weeks
10880484|NCT00463151|OG001|Outcome|Rebamipide 150 mg|Once daily intracolonial administration at a dose of 150 mg for 6 weeks
10880485|NCT00463151|OG002|Outcome|Rebamipide 300 mg|Once daily intracolonial administration at a dose of 300 mg for 6 weeks
10880486|NCT00463151|OG003|Outcome|Placebo|Once daily intracolonial administration of placebo for 6 weeks
10880487|NCT00463151|EG000|Reported Event|Rebamipide 60 mg|Once daily intracolonial administration at a dose of 60 mg for 6 weeks
10880488|NCT00463151|EG001|Reported Event|Rebamipide 150 mg|Once daily intracolonial administration at a dose of 150 mg for 6 weeks
10880489|NCT00463151|EG002|Reported Event|Rebamipide 300 mg|Once daily intracolonial administration at a dose of 300 mg for 6 weeks
10880490|NCT00463151|EG003|Reported Event|Placebo|Once daily intracolonial administration of placebo for 6 weeks
10880491|NCT00463229|BG000|Baseline|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
10880492|NCT00463229|BG001|Baseline|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
10880493|NCT00463229|BG002|Baseline|Total|Total of all reporting groups
10880494|NCT00463229|FG000|Participant Flow|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
10880495|NCT00463229|FG001|Participant Flow|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
10880496|NCT00463229|OG000|Outcome|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
10880497|NCT00463229|OG001|Outcome|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
11146935|NCT01855360|OG000|Outcome|TUDCA and Doxycycline|"INTERVENTION: Patients meeting study criteria were prescribed TUDCA taken orally, 250 mg three times daily. and doxycycline taken orally, 100 mg twice daily.~Tauroursodeoxycholic Acid and Doxycycline"
11146936|NCT01855360|EG000|Reported Event|TUDCA and Doxycycline|"INTERVENTION: Patients meeting study criteria were prescribed TUDCA taken orally, 250 mg three times daily. and doxycycline taken orally, 100 mg twice daily.~Tauroursodeoxycholic Acid and Doxycycline"
11150081|NCT01875471|OG001|Outcome|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
11150082|NCT01875471|EG000|Reported Event|Delefilcon A|"Spherical daily disposable soft contact lens~delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
11146937|NCT01855399|BG000|Baseline|Coaching With Decision Aid-TEC|"All participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data.~The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches will call their assigned peers once a week to provide support for their action steps."
11150083|NCT01875471|EG001|Reported Event|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking~narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
11146938|NCT01855399|BG001|Baseline|Coaching Without the Decision Aid- Print Materials|"Participants randomized to the 'print materials' group will be scheduled for an initial visit with their coach to review usual print diabetes education materials.~The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps."
11146939|NCT01855399|BG002|Baseline|Total|Total of all reporting groups
11146940|NCT01855399|FG000|Participant Flow|Coaching With Decision Aid-TEC|"All participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data.~The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches will call their assigned peers once a week to provide support for their action steps."
11146941|NCT01855399|FG001|Participant Flow|Coaching Without the Decision Aid- Print Materials|"Participants randomized to the 'print materials' group will be scheduled for an initial visit with their coach to review usual print diabetes education materials.~The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps."
11146942|NCT01855399|OG000|Outcome|Peer Coaching + Decision Aid|All participants will be assigned to a peer coaches, who also is a Detroit VA diabetes patients who previously had poor glycemic control but is currently in good control. After their baseline assessment, participants will receive information on their lab and blood pressure values and will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months, coaches will call their assigned peers once a week to provide support for their action steps.
11146943|NCT01855399|OG001|Outcome|Peer Coaching Alone|Participants will be scheduled for an initial visit with their coach to review usual print diabetes education materials. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months, coaches will call their assigned peers once a week to provide support for their action steps.
11146944|NCT01855399|EG000|Reported Event|Coaching With Decision Aid-TEC|"All participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data.~The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches will call their assigned peers once a week to provide support for their action steps."
11146945|NCT01855399|EG001|Reported Event|Coaching Without the Decision Aid- Print Materials|"Participants randomized to the 'print materials' group will be scheduled for an initial visit with their coach to review usual print diabetes education materials.~The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps."
11146946|NCT01855425|BG000|Baseline|Investigational CBCT|"Investigator orders CT as part of Standard of Care. Subject consents to be in study and they are also given a Cone Beam CT.~Radiation: Subjects to receive standard of care CT scan and additional Cone Beam CT scan."
11146947|NCT01855425|FG000|Participant Flow|Investigational CBCT|"Investigator orders Medical CT as part of Standard of Care. Subject consents to be in study and they are also given a Cone Beam CT.~Radiation: Subjects to receive standard of care CT scan and additional Cone Beam CT scan."
11146948|NCT01855425|OG000|Outcome|Investigational CBCT|Investigational CBCT images
11146949|NCT01855425|EG000|Reported Event|Investigational CBCT|"Investigator orders CT as part of Standard of Care. Subject consents to be in study and they are also given a Cone Beam CT.~Radiation: Subjects to receive standard of care CT scan and additional Cone Beam CT scan."
11150084|NCT01875510|BG000|Baseline|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
11150085|NCT01875510|BG001|Baseline|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
11150086|NCT01875510|BG002|Baseline|Total|Total of all reporting groups
11146950|NCT01855750|BG000|Baseline|Treatment Arm B: Ibrutinib+R-CHOP|Participants received ibrutinib 560 milligram (mg) (4*140 mg) capsules orally once daily (Cycle 1 Day 1 to Day 21 of last cycle; 21-day cycles) along with R-CHOP (Rituximab - Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) as a background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus ibrutinib for 6 or 8 cycles per site preference (21 days per cycle).
11146951|NCT01855750|BG001|Baseline|Treatment Arm A: Placebo+R-CHOP|Participants received matching placebo (4 capsules) orally once daily (21-day cycles) along with R-CHOP background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus matching placebo for 6 or 8 cycles per site preference (21 days per cycle).
10880498|NCT00463229|OG000|Outcome|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers [Community Care Access Centre (CCAC) Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist] and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
10880499|NCT00463229|EG000|Reported Event|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
10880500|NCT00463229|EG001|Reported Event|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
10880501|NCT00463346|BG000|Baseline|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
10880502|NCT00463346|BG001|Baseline|Placebo|Placebo dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
10880503|NCT00463346|BG002|Baseline|Total|Total of all reporting groups
10880504|NCT00463346|FG000|Participant Flow|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
10880505|NCT00463346|FG001|Participant Flow|Placebo|dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
11146952|NCT01855750|BG002|Baseline|Total|Total of all reporting groups
11146953|NCT01855750|FG000|Participant Flow|Treatment Arm B: Ibrutinib+R-CHOP|Participants received ibrutinib 560 milligram (mg) (4*140 mg) capsules orally once daily (Cycle 1 Day 1 to Day 21 of last cycle; 21-day cycles) along with R-CHOP (Rituximab - Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) as a background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus ibrutinib for 6 or 8 cycles per site preference (21 days per cycle).
10880506|NCT00463346|OG000|Outcome|Acamprosate|"Acamprosate~1998 mg TID Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
11150087|NCT01875510|FG000|Participant Flow|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
10880507|NCT00463346|OG001|Outcome|Placebo|Placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
10880508|NCT00463346|OG000|Outcome|Acamprosate|"Acamprosate~Acamprosate: Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
10880509|NCT00463346|OG001|Outcome|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
10880510|NCT00463346|EG000|Reported Event|Acamprosate|Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
10880511|NCT00463346|EG001|Reported Event|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
10880512|NCT00463385|BG000|Baseline|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
10880513|NCT00463385|BG001|Baseline|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10887295|NCT00499655|BG001|Baseline|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
10880514|NCT00463385|BG002|Baseline|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880515|NCT00463385|BG003|Baseline|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880516|NCT00463385|BG004|Baseline|Total|Total of all reporting groups
10880517|NCT00463385|FG000|Participant Flow|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
10880518|NCT00463385|FG001|Participant Flow|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880519|NCT00463385|FG002|Participant Flow|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880520|NCT00463385|FG003|Participant Flow|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
11066012|NCT01390818|BG009|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
10880521|NCT00463385|OG000|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
10880522|NCT00463385|OG001|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880523|NCT00463385|OG002|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880524|NCT00463385|OG003|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
11066013|NCT01390818|BG010|Baseline|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11067043|NCT01394978|BG001|Baseline|ProGEL Pleural Air Leak Sealant With Standard Surgical Closure|"ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).~Standard closure, for example, by suturing or stapling, of visible air leaks incurred during resection of lung parenchyma."
10880525|NCT00463385|OG000|Outcome|Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
10880526|NCT00463385|OG001|Outcome|Pomalidomide 2 mg, PositiveJAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880527|NCT00463385|OG002|Outcome|Pomalidomide 2 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880528|NCT00463385|OG003|Outcome|Pomalidomide 0.5 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880529|NCT00463385|OG004|Outcome|Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
10880530|NCT00463385|OG005|Outcome|Pomalidomide 2 mg, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880531|NCT00463385|OG006|Outcome|Pomalidomide 2 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880532|NCT00463385|OG007|Outcome|Pomalidomide 0.5 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880533|NCT00463385|EG000|Reported Event|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
10880534|NCT00463385|EG001|Reported Event|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10887296|NCT00499655|BG002|Baseline|Total|Total of all reporting groups
10887297|NCT00499655|FG000|Participant Flow|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
11067044|NCT01394978|BG002|Baseline|ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure|"ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).~Without standard closure, for example, suturing or stapling, of visible air leaks incurred during resection of lung parenchyma."
11067045|NCT01394978|BG003|Baseline|Total|Total of all reporting groups
11067046|NCT01394978|FG000|Participant Flow|Control|"No treatment.~Control: Standard surgical techniques including staples and sutures."
10880535|NCT00463385|EG002|Reported Event|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880536|NCT00463385|EG003|Reported Event|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
10880537|NCT00463437|BG000|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
11146954|NCT01855750|FG001|Participant Flow|Treatment Arm A: Placebo+R-CHOP|Participants received matching placebo (4 capsules) orally once daily (21-day cycles) along with R-CHOP background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus matching placebo for 6 or 8 cycles per site preference (21 days per cycle).
11146955|NCT01855750|OG000|Outcome|Treatment Arm B: Ibrutinib+R-CHOP|Participants received ibrutinib 560 milligram (mg) (4*140 mg) capsules orally once daily (Cycle 1 Day 1 to Day 21 of last cycle; 21-day cycles) along with R-CHOP (Rituximab - Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) as a background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus ibrutinib for 6 or 8 cycles per site preference (21 days per cycle).
11146956|NCT01855750|OG001|Outcome|Treatment Arm A: Placebo+R-CHOP|Participants received matching placebo (4 capsules) orally once daily (21-day cycles) along with R-CHOP background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus matching placebo for 6 or 8 cycles per site preference (21 days per cycle).
11146957|NCT01855750|EG000|Reported Event|Treatment Arm B: Ibrutinib+R-CHOP|Participants received ibrutinib 560 milligram (mg) (4*140 mg) capsules orally once daily (Cycle 1 Day 1 to Day 21 of last cycle; 21-day cycles) along with R-CHOP (Rituximab - Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) as a background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus ibrutinib for 6 or 8 cycles per site preference (21 days per cycle).
11146958|NCT01855750|EG001|Reported Event|Treatment Arm A: Placebo+R-CHOP|Participants received matching placebo (4 capsules) orally once daily (21-day cycles) along with R-CHOP background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus matching placebo for 6 or 8 cycles per site preference (21 days per cycle).
11146959|NCT01855789|BG000|Baseline|Overall Study Population|All enrolled participants received TCZ at a dose of 162 mg via SC injection qw (if body weight was >/=100 kg) or q2w (if body weight was <100 kg) along with MTX at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a DAS28 score </=3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
11146960|NCT01855789|FG000|Participant Flow|Period 1: All Participants (TCZ + MTX)|All enrolled participants received tocilizumab (TCZ) at a dose of 162 milligrams (mg) via subcutaneous (SC) injection weekly (qw; if body weight was greater than or equal to [>/=] 100 kilograms [kg]) or every 2 weeks (q2w; if body weight was less than [<] 100 kg) along with methotrexate (MTX) at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a disease activity score based on 28 joints (DAS28) less than or equal to (</=) 3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO [placebo]) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
11146961|NCT01855789|FG001|Participant Flow|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
11146962|NCT01855789|FG002|Participant Flow|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
10880538|NCT00463437|BG001|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
11150088|NCT01875510|FG001|Participant Flow|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
11150089|NCT01875510|OG000|Outcome|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
11150090|NCT01875510|OG001|Outcome|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
11150091|NCT01875510|EG000|Reported Event|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
11150092|NCT01875510|EG001|Reported Event|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
10880539|NCT00463437|BG002|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
10880540|NCT00463437|BG003|Baseline|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
10880541|NCT00463437|BG004|Baseline|Total|Total of all reporting groups
10880542|NCT00463437|FG000|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
10880543|NCT00463437|FG001|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
10880544|NCT00463437|FG002|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
10880545|NCT00463437|FG003|Participant Flow|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
10880546|NCT00463437|OG000|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
10880547|NCT00463437|OG001|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
10880548|NCT00463437|OG002|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
11009756|NCT01104025|OG000|Outcome|Induction Therapy|"ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42~ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours).~Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses.~Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients"
10880549|NCT00463437|OG003|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
10880550|NCT00463437|EG000|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
10880551|NCT00463437|EG001|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
10880552|NCT00463437|EG002|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
10880553|NCT00463437|EG003|Reported Event|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
10880554|NCT00463476|BG000|Baseline|2-year Olds|Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
10880555|NCT00463476|BG001|Baseline|5-year Olds|Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
10880556|NCT00463476|BG002|Baseline|Total|Total of all reporting groups
10880557|NCT00463476|FG000|Participant Flow|2-year Olds|Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
10880558|NCT00463476|FG001|Participant Flow|5-year Olds|Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
10880559|NCT00463476|OG000|Outcome|2-year Olds|Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
10880560|NCT00463476|OG001|Outcome|5-year Olds|Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
10880561|NCT00463476|EG000|Reported Event|2-year Olds|Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
10880562|NCT00463476|EG001|Reported Event|5-year Olds|Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
10880563|NCT00463567|BG000|Baseline|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880564|NCT00463567|BG001|Baseline|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880565|NCT00463567|BG002|Baseline|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880566|NCT00463567|BG003|Baseline|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880567|NCT00463567|BG004|Baseline|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880568|NCT00463567|BG005|Baseline|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
11146963|NCT01855789|FG003|Participant Flow|Period 2: Non-Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and did not achieve a DAS28 score </=3.2 at Week 24, continued receiving TCZ at a dose of 162 mg via SC injection qw along with MTX in open label manner orally up to Week 52.
10880569|NCT00463567|BG006|Baseline|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880570|NCT00463567|BG007|Baseline|Total|Total of all reporting groups
10880571|NCT00463567|FG000|Participant Flow|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880572|NCT00463567|FG001|Participant Flow|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
11146964|NCT01855789|OG000|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
10880573|NCT00463567|FG002|Participant Flow|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880574|NCT00463567|FG003|Participant Flow|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880575|NCT00463567|FG004|Participant Flow|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880576|NCT00463567|FG005|Participant Flow|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880577|NCT00463567|FG006|Participant Flow|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880578|NCT00463567|OG000|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880579|NCT00463567|OG001|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880580|NCT00463567|OG002|Outcome|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880581|NCT00463567|OG003|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880582|NCT00463567|OG002|Outcome|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880583|NCT00463567|OG000|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880584|NCT00463567|OG001|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880585|NCT00463567|OG002|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880586|NCT00463567|OG003|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880587|NCT00463567|OG004|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
11146965|NCT01855789|OG001|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
10880588|NCT00463567|OG005|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880589|NCT00463567|OG006|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880590|NCT00463567|OG006|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880591|NCT00463567|EG000|Reported Event|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880592|NCT00463567|EG001|Reported Event|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880593|NCT00463567|EG002|Reported Event|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880594|NCT00463567|EG003|Reported Event|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880595|NCT00463567|EG004|Reported Event|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880596|NCT00463567|EG005|Reported Event|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880597|NCT00463567|EG006|Reported Event|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
10880598|NCT00463580|BG000|Baseline|Infliximab|Participants receiving 5mg/kg of Infliximab at Baseline, Week 2, and Week 6.
10880599|NCT00463580|BG001|Baseline|Placebo|Participants receiving a placebo of normal saline at Baseline, Week 2, and Week 6.
10880600|NCT00463580|BG002|Baseline|Total|Total of all reporting groups
10880601|NCT00463580|FG000|Participant Flow|Infliximab|Participants receiving 5mg/kg of Infliximab at Baseline, Week 2, and Week 6.
10880602|NCT00463580|FG001|Participant Flow|Placebo|Participants receiving a placebo of normal saline at Baseline, Week 2, and Week 6.
10880603|NCT00463580|OG000|Outcome|Infliximab|Participants receiving 5mg/kg of Infliximab at Baseline, Week 2, and Week 6.
10880604|NCT00463580|OG001|Outcome|Placebo|Participants receiving a placebo of normal saline at Baseline, Week 2, and Week 6.
10880605|NCT00463580|OG000|Outcome|CRP Greater Than 5 mg/L|Participants with a baseline CRP measurement of greater than 5 mg/L, who were treated with infliximab.
10880606|NCT00463580|OG001|Outcome|CRP Less Than or Equal to 5 mg/L|Participants with a baseline CRP measurement of less than or equal to 5 mg/L, who were treated with infliximab.
10880607|NCT00463580|OG000|Outcome|All Participants|All study participants are included.
11146966|NCT01855789|OG000|Outcome|Overall Study Population|All enrolled participants received TCZ at a dose of 162 mg via SC injection qw (if body weight was >/=100 kg) or q2w (if body weight was <100 kg) along with MTX at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a DAS28 score </=3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
11150093|NCT01875731|BG000|Baseline|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
11150094|NCT01875731|BG001|Baseline|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
11150095|NCT01875731|BG002|Baseline|Total|Total of all reporting groups
11146967|NCT01855789|EG000|Reported Event|Overall Study Population|All enrolled participants received TCZ at a dose of 162 mg via SC injection qw (if body weight was >/=100 kg) or q2w (if body weight was <100 kg) along with MTX at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a DAS28 score </=3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
11150096|NCT01875731|FG000|Participant Flow|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
10880608|NCT00463580|OG001|Outcome|Baseline Hs-CRP of >1 mg/L|Participants with a baseline hs-CRP value greater than 1 mg/L.
10880609|NCT00463580|OG002|Outcome|Baseline Hs-CRP of > 3|Participants with a baseline hs-CRP value greater than 3 mg/L.
10880610|NCT00463580|OG003|Outcome|Baseline Hs-CRP of >5 mg/L|Participants with a baseline hs-CRP value greater than 5 mg/L.
11067047|NCT01394978|FG001|Participant Flow|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.~ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
11067048|NCT01394978|OG000|Outcome|Control|"No treatment.~Control: Standard surgical techniques including staples and sutures."
11225233|NCT02366689|EG001|Reported Event|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
10880611|NCT00463580|EG000|Reported Event|Infliximab|Participants receiving 5mg/kg of Infliximab at Baseline, Week 2, and Week 6.
10880612|NCT00463580|EG001|Reported Event|Placebo|Participants receiving normal saline at Baseline, Week 2, and Week 6.
10880613|NCT00463606|BG000|Baseline|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
10880614|NCT00463606|BG001|Baseline|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
10880615|NCT00463606|BG002|Baseline|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
10880616|NCT00463606|BG003|Baseline|Total|Total of all reporting groups
10880617|NCT00463606|FG000|Participant Flow|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
10880618|NCT00463606|FG001|Participant Flow|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
10880619|NCT00463606|FG002|Participant Flow|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
11225234|NCT02366689|EG002|Reported Event|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
10880620|NCT00463606|OG000|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
10880621|NCT00463606|OG001|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
10880622|NCT00463606|OG001|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
10880623|NCT00463606|EG000|Reported Event|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
10880624|NCT00463606|EG001|Reported Event|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
10880625|NCT00463606|EG002|Reported Event|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
10880626|NCT00463684|BG000|Baseline|All Subjects|"Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine.~Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.~Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium."
10880627|NCT00463684|FG000|Participant Flow|All Subjects|"Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine.~Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.~Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium."
10880628|NCT00463684|OG000|Outcome|All Subjects|"Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine.~Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.~Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium."
10880629|NCT00463684|EG000|Reported Event|All Subjects|"Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine.~Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.~Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium."
10880630|NCT00463788|BG000|Baseline|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
10880631|NCT00463788|BG001|Baseline|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
10880632|NCT00463788|BG002|Baseline|Total|Total of all reporting groups
11225235|NCT02366767|BG000|Baseline|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
10880633|NCT00463788|FG000|Participant Flow|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
10880634|NCT00463788|FG001|Participant Flow|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
10880635|NCT00463788|OG000|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
10880636|NCT00463788|OG001|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
10880637|NCT00463788|EG000|Reported Event|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly.
10880638|NCT00463788|EG001|Reported Event|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of progressive disease (PD), unacceptable toxicity or withdrawal of consent.
10880639|NCT00463788|EG002|Reported Event|Cisplatin Alone Switched to Cetuximab|On progression, participants in the cisplatin group had the option to switch to cisplatin (75 mg/m^2 IV infusion) plus cetuximab (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progressive disease was reported during the 6 cisplatin cycles or to cetuximab alone (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progression was reported after the 6 cisplatin cycles.
10880640|NCT00463801|BG000|Baseline|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
11009757|NCT01104025|EG000|Reported Event|Induction Therapy|"ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42~ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours).~Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses.~Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients"
10880641|NCT00463801|FG000|Participant Flow|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
10880642|NCT00463801|OG000|Outcome|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
10880643|NCT00463801|EG000|Reported Event|All Patients|All patients
10880644|NCT00463840|BG000|Baseline|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
10880645|NCT00463840|FG000|Participant Flow|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
10880646|NCT00463840|OG000|Outcome|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
11009758|NCT01104090|BG000|Baseline|C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy|Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
10880647|NCT00463840|EG000|Reported Event|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
10880648|NCT00463866|BG000|Baseline|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
10880649|NCT00463866|BG001|Baseline|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
10880650|NCT00463866|BG002|Baseline|Total|Total of all reporting groups
10880651|NCT00463866|FG000|Participant Flow|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
10880652|NCT00463866|FG001|Participant Flow|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
10880653|NCT00463866|OG000|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
10880654|NCT00463866|OG001|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
11348854|NCT04143373|FG001|Participant Flow|Warm Saline of 37 ± 1 ° C|"In this study, during impacted mandibular third molar surgery, within each individual, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side of the same individual, was irrigated with normal saline of 37 ± 1 ° C as for the experimental side.~Within each individual, the left or right sides were allocated randomly for receiving these two types of saline."
10880655|NCT00463866|EG000|Reported Event|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
10880656|NCT00463866|EG001|Reported Event|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
10880657|NCT00464087|BG000|Baseline|Heparin|unfrationated heparin during angioplasty
10880658|NCT00464087|BG001|Baseline|Bivalirudin|bivalirudin during angioplasty
10880659|NCT00464087|BG002|Baseline|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
10880660|NCT00464087|BG003|Baseline|Total|Total of all reporting groups
10880661|NCT00464087|FG000|Participant Flow|Heparin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to unfractionated heparin during angioplasty and receive a minimum dose of 60 U/kg IV.
10880662|NCT00464087|FG001|Participant Flow|Bivalirudin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to Bivalirudin during angioplasty and receive a minimum dose of bolus 0.75 mg/kg IV followed by, infusion of 1.75 mg/kg/hr for the duration of the PCI.
10880663|NCT00464087|FG002|Participant Flow|Screen Failures|These patients were enrolled because they received study drug, but did not have enough disease to require PCI.
10880664|NCT00464087|OG000|Outcome|Heparin|unfractionated heparin during angioplasty
10880665|NCT00464087|OG001|Outcome|Bivalirudin|bivalirudin during angioplasty
10880666|NCT00464087|OG002|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
10880667|NCT00464087|EG000|Reported Event|Heparin|unfrationated heparin during angioplasty
10880668|NCT00464087|EG001|Reported Event|Bivalirudin|bivalirudin during angioplasty
10880669|NCT00464087|EG002|Reported Event|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
10880670|NCT00464204|BG000|Baseline|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
10880671|NCT00464204|BG001|Baseline|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
10880672|NCT00464204|BG002|Baseline|Total|Total of all reporting groups
10880673|NCT00464204|FG000|Participant Flow|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
10880674|NCT00464204|FG001|Participant Flow|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
10880675|NCT00464204|OG000|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
10880676|NCT00464204|OG001|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
10880677|NCT00464204|OG000|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4 Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day.
10880678|NCT00464204|OG001|Outcome|NaCl 0.9 % Arm|NaCl 0.9 % NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
10880679|NCT00464204|EG000|Reported Event|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
10880680|NCT00464204|EG001|Reported Event|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
10880681|NCT00464269|BG000|Baseline|Placebo|Matching Placebo tablets administered twice a day
10880682|NCT00464269|BG001|Baseline|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
10880683|NCT00464269|BG002|Baseline|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10880684|NCT00464269|BG003|Baseline|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10880685|NCT00464269|BG004|Baseline|Total Title|
10880686|NCT00464269|FG000|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
11225236|NCT02366767|BG001|Baseline|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
11225237|NCT02366767|BG002|Baseline|Total|Total of all reporting groups
11225238|NCT02366767|FG000|Participant Flow|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
11225239|NCT02366767|FG001|Participant Flow|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
11225240|NCT02366767|OG000|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
11225241|NCT02366767|OG001|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
11225242|NCT02366767|EG000|Reported Event|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
11225243|NCT02366767|EG001|Reported Event|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
11225244|NCT02366845|BG000|Baseline|Clinician Chosen Dosing|"Usual Care arm: Physician determined fresh frozen plasma (FFP) dosing. Bleeding patients admitted to study hospitals,with chronic liver disease determined to receive fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician. Total dose determined by physician's judgment (current standard of care). Physician chosen dose will be utilized but physician will be unaware of which dosing strategy utilized.~International Normalized Ratio (INR) measurement will be performed within 1 hour after entire plasma transfusion administered. No other transfused blood component, crystalloid or colloidal fluid infused between first and second INR studies except plasma."
11225245|NCT02366845|BG001|Baseline|Algorithm Dosing|"Intervention arm: Plasma transfusion dose determined using algorithm dosing table based on the (pre-transfusion INR) and clinician chosen INR target. Bleeding patients admitted to study hospitals with chronic liver disease determined to receive fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician.~Pre-transfusion INR and target post-transfusion INR used to determine FFP dose. The study table determines dose in (ml/kg) of FFP. INR measurement will be performed within 1 hour after entire plasma transfusion administered. No other transfused blood component,crystalloid or colloidal fluid will be infused between the first and second INR studies except plasma."
11225246|NCT02366845|BG002|Baseline|Total|Total of all reporting groups
11225247|NCT02366845|FG000|Participant Flow|Clinician Chosen Dosing|"University of Colorado Hospital or Denver Health bleeding inpatients with chronic liver disease receiving fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician. Total dose determined by physician. (Current standard of care). Physician chosen dose will be utilized but physician blinded to which dosing strategy used.~INR measurement performed within 1 hour after total transfusion of plasma. No other transfused blood component, crystalloid or colloidal fluid infused between the first and second INR studies except plasma~Fresh Frozen Plasma: An INR dose-response curve with associated transfusion algorithm was generated for plasma in bleeding patients with chronic liver disease. In the intervention arm we will determine the plasma transfusion dose using the algorithm dosing table based on the pre-transfusion INR and the clinician chosen INR target. In the usual care group the dosing will be determined by the clinician."
11225248|NCT02366845|FG001|Participant Flow|Algorithm Dosing|"University of Colorado Hospital or Denver Health bleeding inpatients with chronic liver disease receiving fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician. This group received plasma doses based on study dosing algorithm table.~Pre-transfusion INR, target post-transfusion INR, and study table used to determine FFP dose in (ml/kg). INR measurement performed within 1 hour after entire FFP transfusion administered. No other transfused blood component,crystalloid or colloidal fluid infused between first and second INR studies except plasma.~Fresh Frozen Plasma: An INR dose-response curve with associated transfusion algorithm was generated for plasma in bleeding patients with chronic liver disease. In the intervention arm we will determine the plasma transfusion dose using the algorithm dosing table based on the pre-transfusion INR and the clinician chosen INR target. In the usual care group the dosing will be determined by the clinician."
10880687|NCT00464269|FG001|Participant Flow|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
11225249|NCT02366845|OG000|Outcome|Clinician Chosen Dosing|"Usual Care arm: Physician determined FFP dosing. Bleeding patients admitted to study hospitals,with chronic liver disease determined to receive fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician. Total dose determined by physician's judgment (current standard of care). Physician chosen dose will be utilized but physician will be unaware of which dosing strategy utilized.~INR measurement will be performed within 1 hour after entire plasma transfusion administered. No other transfused blood component, crystalloid or colloidal fluid infused between first and second INR studies except plasma"
11225250|NCT02366845|OG001|Outcome|Algorithm Dosing|"Intervention arm: Plasma transfusion dose determined using algorithm dosing table based on the pre-transfusion INR and clinician chosen INR target. Bleeding patients admitted to study hospitals with chronic liver disease determined to receive fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician.~Pre-transfusion INR and target post-transfusion INR used to determine FFP dose. The study table determines dose in (ml/kg) of FFP. INR measurement will be performed within 1 hour after entire plasma transfusion administered. No other transfused blood component,crystalloid or colloidal fluid will be infused between the first and second INR studies except plasma."
10880688|NCT00464269|FG002|Participant Flow|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10880689|NCT00464269|FG003|Participant Flow|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
11009759|NCT01104090|BG001|Baseline|C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy|Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
11009760|NCT01104090|BG002|Baseline|Total|Total of all reporting groups
10880690|NCT00464269|OG000|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
10880691|NCT00464269|OG001|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
10880692|NCT00464269|OG002|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
10880693|NCT00464269|OG003|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
10880694|NCT00464269|OG000|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
10880695|NCT00464269|OG001|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
10880696|NCT00464269|EG000|Reported Event|Placebo|Matching Placebo tablets administered twice a day
10880697|NCT00464269|EG001|Reported Event|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
10880698|NCT00464269|EG002|Reported Event|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
11150097|NCT01875731|FG001|Participant Flow|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
10880699|NCT00464269|EG003|Reported Event|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10880700|NCT00464308|BG000|Baseline|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880701|NCT00464308|BG001|Baseline|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880702|NCT00464308|BG002|Baseline|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880703|NCT00464308|BG003|Baseline|Total|Total of all reporting groups
10880704|NCT00464308|FG000|Participant Flow|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880705|NCT00464308|FG001|Participant Flow|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880706|NCT00464308|FG002|Participant Flow|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880707|NCT00464308|OG000|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880708|NCT00464308|OG001|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880709|NCT00464308|OG002|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880710|NCT00464308|EG000|Reported Event|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880711|NCT00464308|EG001|Reported Event|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880712|NCT00464308|EG002|Reported Event|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
10880713|NCT00464334|BG000|Baseline|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
10880714|NCT00464334|BG001|Baseline|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
10880715|NCT00464334|BG002|Baseline|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
10880716|NCT00464334|BG003|Baseline|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
10880717|NCT00464334|BG004|Baseline|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
10880718|NCT00464334|BG005|Baseline|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
10880719|NCT00464334|BG006|Baseline|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
11150098|NCT01875731|OG000|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
11150099|NCT01875731|OG001|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
11150100|NCT01875731|EG000|Reported Event|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
10850964|NCT03410992|EG001|Reported Event|Bimekizumab 320 mg Q4W (SS)|Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS.
11150101|NCT01875731|EG001|Reported Event|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
10880720|NCT00464334|BG007|Baseline|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
10880721|NCT00464334|BG008|Baseline|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
10880722|NCT00464334|BG009|Baseline|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
10880723|NCT00464334|BG010|Baseline|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
10880724|NCT00464334|BG011|Baseline|Total|Total of all reporting groups
10880725|NCT00464334|FG000|Participant Flow|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
10880726|NCT00464334|FG001|Participant Flow|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
10880727|NCT00464334|FG002|Participant Flow|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
10880728|NCT00464334|FG003|Participant Flow|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
10880729|NCT00464334|FG004|Participant Flow|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
10880730|NCT00464334|FG005|Participant Flow|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
11009761|NCT01104090|FG000|Participant Flow|C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy|Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
10880731|NCT00464334|FG006|Participant Flow|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
10880732|NCT00464334|FG007|Participant Flow|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
10880733|NCT00464334|FG008|Participant Flow|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
10880734|NCT00464334|FG009|Participant Flow|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
10880735|NCT00464334|FG010|Participant Flow|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
10880736|NCT00464334|OG000|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
10880737|NCT00464334|OG001|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
10880738|NCT00464334|OG002|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
10880739|NCT00464334|OG003|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
10880740|NCT00464334|OG004|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
10880741|NCT00464334|OG005|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
10880742|NCT00464334|OG006|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
10880743|NCT00464334|OG007|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
10880744|NCT00464334|OG008|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
10880745|NCT00464334|OG009|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
10880746|NCT00464334|OG010|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
10880747|NCT00464334|OG000|Outcome|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
11342068|NCT03696342|EG001|Reported Event|Zymar|"Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.~Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
10880748|NCT00464334|OG001|Outcome|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
10880749|NCT00464334|OG002|Outcome|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
10880750|NCT00464334|OG003|Outcome|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
10880751|NCT00464334|OG004|Outcome|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
10880752|NCT00464334|OG005|Outcome|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
10880753|NCT00464334|OG006|Outcome|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
10880754|NCT00464334|OG007|Outcome|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
10880755|NCT00464334|OG008|Outcome|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
10880756|NCT00464334|OG009|Outcome|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
10880757|NCT00464334|OG010|Outcome|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
10880758|NCT00464334|EG000|Reported Event|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
10880759|NCT00464334|EG001|Reported Event|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
10880760|NCT00464334|EG002|Reported Event|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
10880761|NCT00464334|EG003|Reported Event|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
10880762|NCT00464334|EG004|Reported Event|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
10880763|NCT00464334|EG005|Reported Event|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
10880764|NCT00464334|EG006|Reported Event|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
10880765|NCT00464334|EG007|Reported Event|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
10880766|NCT00464334|EG008|Reported Event|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
10880767|NCT00464334|EG009|Reported Event|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
10880768|NCT00464334|EG010|Reported Event|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
10880769|NCT00464438|BG000|Baseline|Gatifloxacin 0.3%|
10880770|NCT00464438|BG001|Baseline|Moxifloxacin 0.5%|
10880771|NCT00464438|BG002|Baseline|Total|Total of all reporting groups
10880772|NCT00464438|FG000|Participant Flow|Gatifloxacin 0.3%|
10880773|NCT00464438|FG001|Participant Flow|Moxifloxacin 0.5%|
10880774|NCT00464438|OG000|Outcome|Gatifloxacin 0.3%|
10880775|NCT00464438|OG001|Outcome|Moxifloxacin 0.5%|
10880776|NCT00464438|EG000|Reported Event|Gatifloxacin 0.3%|
10880777|NCT00464438|EG001|Reported Event|Moxifloxacin 0.5%|
10880778|NCT00464464|BG000|Baseline|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
10880779|NCT00464464|BG001|Baseline|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
10880780|NCT00464464|BG002|Baseline|Total|Total of all reporting groups
10880781|NCT00464464|FG000|Participant Flow|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
10880782|NCT00464464|FG001|Participant Flow|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
10880783|NCT00464464|OG000|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
10880784|NCT00464464|OG001|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
10880785|NCT00464464|EG000|Reported Event|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
10880786|NCT00464464|EG001|Reported Event|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
10880787|NCT00464490|BG000|Baseline|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
10880788|NCT00464490|BG001|Baseline|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
11009762|NCT01104090|FG001|Participant Flow|C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy|Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
11009763|NCT01104090|OG000|Outcome|C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy|Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
11009764|NCT01104090|OG001|Outcome|C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy|Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
11009765|NCT01104090|OG000|Outcome|C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy|Patients assigned to this arm will be intubated using C-MAC with direct laryngoscopy first and then using C-MAC with indirect laryngoscopy.
11009766|NCT01104090|OG001|Outcome|C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy|Patients assigned to this arm will be intubated using C-MAC with indirect laryngoscopy first and then using C_MAC with direct laryngoscopy.
10880789|NCT00464490|BG002|Baseline|Total|Total of all reporting groups
10880790|NCT00464490|FG000|Participant Flow|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
10880791|NCT00464490|FG001|Participant Flow|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
11009767|NCT01104090|EG000|Reported Event|C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy|Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
10880792|NCT00464490|OG000|Outcome|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
10880793|NCT00464490|OG001|Outcome|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
10880794|NCT00464490|EG000|Reported Event|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
10880795|NCT00464490|EG001|Reported Event|Standard Hospital Protocol (CG)|Control. Hospital weaning per standard protocol
10880796|NCT00464542|BG000|Baseline|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
10880797|NCT00464542|FG000|Participant Flow|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
10880798|NCT00464542|OG000|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
10880799|NCT00464542|EG000|Reported Event|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
10880800|NCT00464568|BG000|Baseline|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
10880801|NCT00464568|FG000|Participant Flow|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 microgram (mcg) or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
10880802|NCT00464568|OG000|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
11009768|NCT01104090|EG001|Reported Event|C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy|Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
10880803|NCT00464568|OG001|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
10880804|NCT00464568|OG002|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
10880805|NCT00464568|OG003|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
10880806|NCT00464568|OG004|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
10880807|NCT00464568|OG000|Outcome|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
10880808|NCT00464568|OG000|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
10880809|NCT00464568|OG001|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
10880810|NCT00464568|OG002|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
10880811|NCT00464568|OG003|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
10880812|NCT00464568|EG000|Reported Event|Placebo|Participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
10880813|NCT00464568|EG001|Reported Event|GSK256066 1 mcg|Participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
10880814|NCT00464568|EG002|Reported Event|GSK256066 10 mcg|Participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
11009769|NCT01104103|BG000|Baseline|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
11150102|NCT01875783|BG000|Baseline|OCT Imaging|"All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.~OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina."
11342069|NCT03696576|BG000|Baseline|PhoRTE|"This group will undergo standard PhoRTE therapy.~PhoRTE: Completing of PhoRTE voice therapy."
10880815|NCT00464568|EG003|Reported Event|GSK256066 50 mcg|Participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
10880816|NCT00464568|EG004|Reported Event|GSK256066 200 mcg|Participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
10880817|NCT00464620|BG000|Baseline|Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880818|NCT00464620|FG000|Participant Flow|GIST: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880819|NCT00464620|FG001|Participant Flow|Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880820|NCT00464620|FG002|Participant Flow|Indolent Subtype: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880821|NCT00464620|OG000|Outcome|GIST: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880822|NCT00464620|OG001|Outcome|Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880823|NCT00464620|OG002|Outcome|Indolent Subtype: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880824|NCT00464620|OG000|Outcome|Indolent Subtypes: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880825|NCT00464620|OG001|Outcome|Indolent Subtype: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880826|NCT00464620|OG000|Outcome|Indolent Subtype: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880827|NCT00464620|OG000|Outcome|Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880828|NCT00464620|OG000|Outcome|Osteosarcoma|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880829|NCT00464620|OG001|Outcome|Leiomyosarcoma|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880830|NCT00464620|OG002|Outcome|MFH/Undifferentiated Pleomorphic Sarcoma|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880831|NCT00464620|EG000|Reported Event|GIST, Aggressive, Indolent Subtypes|"Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles~Dasatinib: oral agent, continuous dosing, Cycles = 28 days"
10880832|NCT00464646|BG000|Baseline|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
10880833|NCT00464646|BG001|Baseline|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
10880834|NCT00464646|BG002|Baseline|Total|Total of all reporting groups
10880835|NCT00464646|FG000|Participant Flow|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
10880836|NCT00464646|FG001|Participant Flow|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
10880837|NCT00464646|OG000|Outcome|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
10880838|NCT00464646|OG001|Outcome|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
10880839|NCT00464646|OG000|Outcome|Cohort A|"Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)~Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer~Epirubicin: Both Cohorts: Epirubicin 90 mg/m2 IV every 21 days x 4 cycles~Cyclophosphamide: Both Cohorts: Cyclophosphamide 600 mg/m2 IV every 21 days x 4 cycles~Docetaxel: Both Cohorts: Docetaxel 100 mg/m2 IV on Day 1 every 21 days x 4 cycles~Trastuzumab: Cohort A: Pre-op therapy - 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly (16+ weeks) until 1-7 days prior to surgery. Post-operative therapy (beginning no sooner than 28 days after surgery and continuing every 3 weeks x 13 doses) - 8 mg/kg IV first post-op dose, then subsequent doses at 6 mg/kg IV~Cohort B: 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly on days 1, 8, and 15. Three (3) weeks after last dose of docetaxel, 6 mg/kg IV and continuing every 3 weeks x 13 doses~Bevacizumab: Cohort A: Cycles 1-4, 15 mg/kg IV on day 1 of cycle 4 only; Cycles 5-7, 15 mg/kg IV on day 1 every 21 days x 3 cycles; post-operative therapy (beginning no sooner than 28 days after surgery), 15 mg/kg IV every 3 weeks x 13 doses~Cohort B: Cycles 5-8, 15 mg/kg IV on day 1 every 21 days x 4 cycles; beginning 3 weeks after last dose of docetaxel, 15 mg/kg IV every 3 weeks x 13 doses"
10880840|NCT00464646|EG000|Reported Event|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
10880841|NCT00464646|EG001|Reported Event|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
10880842|NCT00464672|BG000|Baseline|Influenza Virus Vaccine|Injections of the investigational influenza virus vaccine were administered intramuscularly
10880843|NCT00464672|BG001|Baseline|Comparator Influenza Vaccine|Injections of the comparator influenza vaccine were administered intramuscularly
10880844|NCT00464672|BG002|Baseline|Total|Total of all reporting groups
10880845|NCT00464672|FG000|Participant Flow|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
10880846|NCT00464672|FG001|Participant Flow|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
10880847|NCT00464672|FG002|Participant Flow|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
10880848|NCT00464672|FG003|Participant Flow|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
10880849|NCT00464672|FG004|Participant Flow|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
10880850|NCT00464672|FG005|Participant Flow|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
10880851|NCT00464672|OG000|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
10880852|NCT00464672|OG001|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
10880853|NCT00464672|OG002|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
10880854|NCT00464672|OG003|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
10880855|NCT00464672|OG004|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
10880856|NCT00464672|OG005|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
10880857|NCT00464672|OG000|Outcome|Influenza Virus Vaccine|One injection of the investigational influenza virus vaccine was administered intramuscularly
10880858|NCT00464672|OG001|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza vaccine was administered intramuscularly
10880859|NCT00464672|OG000|Outcome|Influenza Virus Vaccine|Injection of the investigational influenza virus vaccine were administered intramuscularly
10880860|NCT00464672|OG001|Outcome|Comparator Influenza Vaccine|Injection of the comparator influenza vaccine were administered intramuscularly
10880861|NCT00464672|OG000|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
11009770|NCT01104103|BG001|Baseline|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
10880862|NCT00464672|OG001|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
10880863|NCT00464672|OG002|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
10880864|NCT00464672|OG003|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
10880865|NCT00464672|OG004|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
10880866|NCT00464672|OG005|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
10880867|NCT00464672|OG000|Outcome|Influenza Virus Vaccine (Injection 1)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
10880868|NCT00464672|OG001|Outcome|Comparator Influenza Vaccine (Injection 1)|Injections of the comparator influenza vaccine were administered intramuscularly.
11009771|NCT01104103|BG002|Baseline|Total|Total of all reporting groups
10880869|NCT00464672|OG002|Outcome|Influenza Virus Vaccine (Injection 2)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
11009772|NCT01104103|FG000|Participant Flow|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
10880870|NCT00464672|OG003|Outcome|Comparator Influenza Vaccine (Injection 2)|Injections of the comparator influenza vaccine were administered intramuscularly.
10880871|NCT00464672|EG000|Reported Event|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
10880872|NCT00464672|EG001|Reported Event|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
10880873|NCT00464672|EG002|Reported Event|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
10880874|NCT00464672|EG003|Reported Event|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
10880875|NCT00464672|EG004|Reported Event|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
10880876|NCT00464672|EG005|Reported Event|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
10880877|NCT00464685|BG000|Baseline|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
10880878|NCT00464685|BG001|Baseline|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
10880879|NCT00464685|BG002|Baseline|Total|Total of all reporting groups
11009773|NCT01104103|FG001|Participant Flow|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
11009774|NCT01104103|OG000|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
11009775|NCT01104103|OG001|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
11009776|NCT01104103|EG000|Reported Event|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
11009777|NCT01104103|EG001|Reported Event|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
10880880|NCT00464685|FG000|Participant Flow|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
10880881|NCT00464685|FG001|Participant Flow|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
10880882|NCT00464685|OG000|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
10880883|NCT00464685|OG001|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
10880884|NCT00464685|EG000|Reported Event|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
10880885|NCT00464685|EG001|Reported Event|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
10880886|NCT00464698|BG000|Baseline|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
10880887|NCT00464698|FG000|Participant Flow|All Study Participants|Duloxetine Week 1 dose: 30mg Duloxetine Weeks 2-4 dose: 60mg Duloxetine Weeks 5-17 dose: 120mg
10880888|NCT00464698|OG000|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
10880889|NCT00464698|EG000|Reported Event|Duloxetine: Week 1 Dose: 30mg|
10880890|NCT00464698|EG001|Reported Event|Duloxetine Weeks 2-4 Dose: 60mg|
10880891|NCT00464698|EG002|Reported Event|Duloxetine Weeks 5-17 Dose: 120mg|
11146968|NCT01855828|BG000|Baseline|Chemo Plus Pertuzumab,Trastuzumab|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
11342070|NCT03696576|BG001|Baseline|PhoRTE + EMST|"This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.~EMST: Training of the respiratory system muscles using the EMST device.~PhoRTE: Completing of PhoRTE voice therapy."
10880892|NCT00464711|BG000|Baseline|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
10880893|NCT00464711|FG000|Participant Flow|Escitalopram|40 subjects met inclusion/exclusion criteria and started treatment with escitalopram
11342071|NCT03696576|BG002|Baseline|Total|Total of all reporting groups
10880894|NCT00464711|OG000|Outcome|Open Label Escitalopram|All subjects were treated with open label escitalopram
10880895|NCT00464711|EG000|Reported Event|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
10880896|NCT00464737|BG000|Baseline|Placebo|Placebo
10880897|NCT00464737|BG001|Baseline|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
10880898|NCT00464737|BG002|Baseline|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
10880899|NCT00464737|BG003|Baseline|Total|Total of all reporting groups
10880900|NCT00464737|FG000|Participant Flow|Placebo|Placebo
10880901|NCT00464737|FG001|Participant Flow|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
10880902|NCT00464737|FG002|Participant Flow|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
10880903|NCT00464737|OG000|Outcome|Placebo|Placebo
10880904|NCT00464737|OG001|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
10880905|NCT00464737|OG002|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
10880906|NCT00464737|EG000|Reported Event|Placebo|Placebo
10880907|NCT00464737|EG001|Reported Event|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
10880908|NCT00464737|EG002|Reported Event|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
10880909|NCT00464815|BG000|Baseline|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
10880910|NCT00464815|BG001|Baseline|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
10880911|NCT00464815|BG002|Baseline|Total|Total of all reporting groups
10880912|NCT00464815|FG000|Participant Flow|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
10880913|NCT00464815|FG001|Participant Flow|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
10880914|NCT00464815|OG000|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
10880915|NCT00464815|OG001|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
10880916|NCT00464815|EG000|Reported Event|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix™ (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
10880917|NCT00464815|EG001|Reported Event|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax™ ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
10887144|NCT00499083|OG000|Outcome|Vaccine|"Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.~Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.~Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion~All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections."
10887145|NCT00499083|EG000|Reported Event|Vaccine|"Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.~Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.~Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion~All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections."
10887146|NCT00499096|BG000|Baseline|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease (CVD); group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
10887147|NCT00499096|BG001|Baseline|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease (CVD) will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
10887148|NCT00499096|BG002|Baseline|Total|Total of all reporting groups
10887149|NCT00499096|FG000|Participant Flow|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
10887150|NCT00499096|FG001|Participant Flow|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
10887151|NCT00499096|OG000|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
10887152|NCT00499096|OG001|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
10887153|NCT00499096|OG000|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder~Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
10887154|NCT00499096|OG000|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
11009778|NCT01104155|BG000|Baseline|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
10880918|NCT00464945|BG000|Baseline|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880919|NCT00464945|BG001|Baseline|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880920|NCT00464945|BG002|Baseline|Total|Total of all reporting groups
10880921|NCT00464945|FG000|Participant Flow|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880922|NCT00464945|FG001|Participant Flow|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880923|NCT00464945|OG000|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880924|NCT00464945|OG001|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880925|NCT00464945|OG000|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
10880926|NCT00464945|OG001|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
10880927|NCT00464945|OG002|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
10880928|NCT00464945|OG003|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
10880929|NCT00464945|OG004|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
10880930|NCT00464945|OG005|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
10880931|NCT00464945|OG006|Outcome|13vPnC Manufacturing Toddler Dose|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880932|NCT00464945|OG007|Outcome|13vPnC Pilot Toddler Dose|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
11146969|NCT01855828|FG000|Participant Flow|Chemo Plus Pertuzumab,Trastuzumab|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
10880933|NCT00464945|OG000|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880934|NCT00464945|OG001|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880935|NCT00464945|OG000|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
10880936|NCT00464945|OG001|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
10880937|NCT00464945|EG000|Reported Event|13vPnC Manufacturing Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
10880938|NCT00464945|EG001|Reported Event|13vPnC Pilot Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
10880939|NCT00464945|EG002|Reported Event|13vPnC Manufacturing Post-Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
10880940|NCT00464945|EG003|Reported Event|13vPnC Pilot Post-Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
10880941|NCT00464945|EG004|Reported Event|13vPnC Manufacturing Toddler Series|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
11150103|NCT01875783|FG000|Participant Flow|OCT Imaging|"All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.~OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina."
10880942|NCT00464945|EG005|Reported Event|13vPnC Pilot Toddler Series|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
10880943|NCT00465088|BG000|Baseline|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
10880944|NCT00465088|BG001|Baseline|Atorvastatin|40 mg atorvastatin once daily at bedtime
10880945|NCT00465088|BG002|Baseline|Total|Total of all reporting groups
10880946|NCT00465088|FG000|Participant Flow|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
10880947|NCT00465088|FG001|Participant Flow|Atorvastatin|40 mg atorvastatin once daily at bedtime
10880948|NCT00465088|OG000|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
10880949|NCT00465088|OG001|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
10880950|NCT00465088|EG000|Reported Event|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
10880951|NCT00465088|EG001|Reported Event|Atorvastatin|40 mg atorvastatin once daily at bedtime
10880952|NCT00465101|BG000|Baseline|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
10880953|NCT00465101|FG000|Participant Flow|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
10880954|NCT00465101|OG000|Outcome|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
10880955|NCT00465101|OG000|Outcome|Treatment Related Complication at 3 Months|
10880956|NCT00465101|OG000|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
10880957|NCT00465101|OG000|Outcome|Baseline QoL Score|
10880958|NCT00465101|OG001|Outcome|3 Months|
10880959|NCT00465101|OG002|Outcome|6 Months|
10880960|NCT00465101|OG003|Outcome|1 Year|
10880961|NCT00465101|OG004|Outcome|2 Years|
10880962|NCT00465101|OG005|Outcome|3 Years|
10880963|NCT00465101|OG006|Outcome|4 Years|
10880964|NCT00465101|OG007|Outcome|5 Years|
10880965|NCT00465101|OG000|Outcome|Peri-Operative (0-14 Days)|
10880966|NCT00465101|OG001|Outcome|Delayed (15-91 Days)|
10880967|NCT00465101|OG000|Outcome|Baseline|
10880968|NCT00465101|OG005|Outcome|3 Year|
10880969|NCT00465101|OG000|Outcome|Return to Activity (Days)|
10880970|NCT00465101|OG000|Outcome|Length of Hospital Stay (Hours)|
10880971|NCT00465101|OG000|Outcome|Length of Catheterization|
10880972|NCT00465101|OG000|Outcome|Length of Procedure (Min)|
10880973|NCT00465101|OG000|Outcome|Length of Lasing Time|
10880974|NCT00465101|OG000|Outcome|Number of Fibers Used|
10880975|NCT00465101|OG000|Outcome|Total Energy Delivered|
10880976|NCT00465101|OG000|Outcome|Retrograde Ejaculation Occurrence Rate|
10880977|NCT00465101|EG000|Reported Event|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
10880978|NCT00465179|BG000|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
10880979|NCT00465179|FG000|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
10880980|NCT00465179|OG000|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
10880981|NCT00465179|EG000|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
10880982|NCT00465270|BG000|Baseline|Device|AMPLATZER PFO Occluder: patent foramen ovale closure device
10880983|NCT00465270|BG001|Baseline|Medical Management|Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
10880984|NCT00465270|BG002|Baseline|Total|Total of all reporting groups
10880985|NCT00465270|FG000|Participant Flow|Device|AMPLATZER PFO Occluder: patent foramen ovale closure device
10880986|NCT00465270|FG001|Participant Flow|Medical Management|Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
10880987|NCT00465270|OG000|Outcome|Device|AMPLATZER PFO Occluder: patent foramen ovale closure device
10880988|NCT00465270|OG001|Outcome|Medical Management|Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
10880989|NCT00465270|EG000|Reported Event|Device|AMPLATZER PFO Occluder: patent foramen ovale closure device
10880990|NCT00465270|EG001|Reported Event|Medical Management|Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
10880991|NCT00465361|BG000|Baseline|Intervention|Performance after receiving feedback and educational module
10880992|NCT00465361|FG000|Participant Flow|Intervention|Performance after receiving feedback and educational module
10880993|NCT00465361|OG000|Outcome|Intervention|Performance after receiving feedback and educational module
10880994|NCT00465361|EG000|Reported Event|Intervention|Performance after receiving feedback and educational module
10880995|NCT00465530|BG000|Baseline|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
10880996|NCT00465530|BG001|Baseline|Saline (Once Daily, 40 mL to Each Nostril)|
10880997|NCT00465530|BG002|Baseline|Total|Total of all reporting groups
10880998|NCT00465530|FG000|Participant Flow|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
10880999|NCT00465530|FG001|Participant Flow|Saline (Once Daily, 40 mL to Each Nostril)|
10881000|NCT00465530|OG000|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
10881001|NCT00465530|OG001|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
10881002|NCT00465530|EG000|Reported Event|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
10881003|NCT00465530|EG001|Reported Event|Saline (Once Daily, 40 mL to Each Nostril)|
10881004|NCT00465569|BG000|Baseline|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
10881005|NCT00465569|BG001|Baseline|Placebo|Placebo
10881006|NCT00465569|BG002|Baseline|Total|Total of all reporting groups
10881007|NCT00465569|FG000|Participant Flow|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
10881008|NCT00465569|FG001|Participant Flow|Placebo|Pre-measured doses of ProFree, a dry, milk free powder
10881009|NCT00465569|OG000|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
10881010|NCT00465569|OG001|Outcome|Placebo|Placebo
10881011|NCT00465569|EG000|Reported Event|Active Treatment|Adverse event information is based on percentages of doses. There were 2437 total doses in the active treatment arm with a median of 177 and a range of 155-242 per participant. There was a total of 13 participants in the active treatment arm who were analyzed for the Adverse Events data reported below.
10881012|NCT00465569|EG001|Reported Event|Placebo|Adverse event information is based on percentages of doses. There were 1193 total doses in the placebo arm with a median of 171 and a range of 152-199 per participant. There was a total of 7 participants in the placebo arm who were analyzed for the Adverse Events data reported below.
10881013|NCT00465595|BG000|Baseline|Low-Dose First|The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
10881014|NCT00465595|BG001|Baseline|High-Dose First|The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
10881015|NCT00465595|BG002|Baseline|Total|Total of all reporting groups
10881016|NCT00465595|FG000|Participant Flow|Low-Dose First|The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
10881017|NCT00465595|FG001|Participant Flow|High-Dose First|The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
10881018|NCT00465595|OG000|Outcome|Low-Dose First Baseline|The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
10881019|NCT00465595|OG001|Outcome|Low-Dose First Post Session 1|The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
10881020|NCT00465595|OG002|Outcome|Low-Dose First Post Session 2|The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
10881021|NCT00465595|OG003|Outcome|Low-Dose First 6 Month|The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
10881022|NCT00465595|OG004|Outcome|High-Dose First Baseline|The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
10881023|NCT00465595|OG005|Outcome|High-Dose First Post Session 1|The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
10881024|NCT00465595|OG006|Outcome|High-Dose First Post Session 2|The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
10881025|NCT00465595|OG007|Outcome|High-Dose First 6 Month|The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
10881026|NCT00465595|EG000|Reported Event|Low Dose Condition (Group)|The experimental design of this study is a complete cross-over, with two groups of participants receiving the low and high doses of psilocybin in counterbalance order. The Low Dose Group is comprised of all low dose psilocybin sessions (n=50). The number of sessions is different from the total enrollment because of dropouts.
10881027|NCT00465595|EG001|Reported Event|High Dose Condition (Group)|The experimental design of this study is a complete cross-over, with two groups of participants receiving the low and high doses of psilocybin in counterbalance order. The High Dose Group is comprised of all high dose psilocybin sessions (n=50). The number of sessions is different from the total enrollment because of dropouts.
10881028|NCT00465647|BG000|Baseline|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881029|NCT00465647|BG001|Baseline|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881030|NCT00465647|BG002|Baseline|≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881031|NCT00465647|BG003|Baseline|≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881032|NCT00465647|BG004|Baseline|Total|Total of all reporting groups
10881033|NCT00465647|FG000|Participant Flow|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881034|NCT00465647|FG001|Participant Flow|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881035|NCT00465647|FG002|Participant Flow|≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881036|NCT00465647|FG003|Participant Flow|≥ 12 Years to < 17 Years|Adolescent- received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881037|NCT00465647|OG000|Outcome|All Patients|A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.
10881038|NCT00465647|OG000|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881039|NCT00465647|OG001|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881040|NCT00465647|OG002|Outcome|Oral ≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881041|NCT00465647|OG003|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
11342072|NCT03696576|FG000|Participant Flow|PhoRTE|"This group will undergo standard PhoRTE therapy.~PhoRTE: Completing of PhoRTE voice therapy."
11342073|NCT03696576|FG001|Participant Flow|PhoRTE + EMST|"This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.~EMST: Training of the respiratory system muscles using the EMST device.~PhoRTE: Completing of PhoRTE voice therapy."
10881042|NCT00465647|OG000|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
10881043|NCT00465647|OG002|Outcome|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881044|NCT00465647|OG001|Outcome|Oral ≥ 13 Months to < 5 Years|Young child (Data for this group not collected. Test not appropriate for this age)
10881045|NCT00465647|OG002|Outcome|Oral ≥ 5 Years to <12 Years|Older child (Data for this group not collected. Test not appropriate for this age)
10881046|NCT00465647|OG003|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881047|NCT00465647|EG000|Reported Event|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881048|NCT00465647|EG001|Reported Event|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881049|NCT00465647|EG002|Reported Event|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881050|NCT00465647|EG003|Reported Event|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
10881051|NCT00465647|EG004|Reported Event|Parenteral ≥ 28 Days to < 13 Months|Infant and toddler - received parenteral analgesia up to 48 hours postsurgery.
10881052|NCT00465647|EG005|Reported Event|Parenteral ≥ 13 Months to < 5 Years|Young child - received parenteral analgesia up to 48 hours postsurgery.
10881053|NCT00465647|EG006|Reported Event|Parenteral ≥ 5 Years to < 12 Years|Older child - received parenteral analgesia up to 48 hours postsurgery.
10881054|NCT00465647|EG007|Reported Event|Parenteral ≥ 12 Years to < 17 Years|Adolescent - received parenteral analgesia up to 48 hours postsurgery.
10881055|NCT00465738|BG000|Baseline|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
10881056|NCT00465738|BG001|Baseline|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
10881057|NCT00465738|BG002|Baseline|Total|Total of all reporting groups
10881058|NCT00465738|FG000|Participant Flow|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
10881059|NCT00465738|FG001|Participant Flow|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
10881060|NCT00465738|OG000|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
10881061|NCT00465738|OG001|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
11146970|NCT01855828|OG000|Outcome|Chemo Plus Pertuzumab,Trastuzumab|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
11342074|NCT03696576|OG000|Outcome|PhoRTE|"This group received standard PhoRTE therapy.~PhoRTE: Completing of PhoRTE voice therapy."
10881062|NCT00465738|EG000|Reported Event|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
10881063|NCT00465738|EG001|Reported Event|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
10881064|NCT00465816|BG000|Baseline|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881065|NCT00465816|BG001|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0.
10881066|NCT00465816|BG002|Baseline|Twinrix Group|Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881067|NCT00465816|BG003|Baseline|Total|Total of all reporting groups
10881068|NCT00465816|FG000|Participant Flow|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881069|NCT00465816|FG001|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0.
10881070|NCT00465816|FG002|Participant Flow|Twinrix Group|Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881071|NCT00465816|OG000|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881072|NCT00465816|OG001|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0.
10881073|NCT00465816|OG001|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881074|NCT00465816|OG002|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881075|NCT00465816|EG000|Reported Event|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881076|NCT00465816|EG001|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0.
10881077|NCT00465816|EG002|Reported Event|Twinrix Group|Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
10881078|NCT00465894|BG000|Baseline|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
10881079|NCT00465894|BG001|Baseline|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
10881080|NCT00465894|BG002|Baseline|Total|Total of all reporting groups
10881081|NCT00465894|FG000|Participant Flow|Group 1: Extended Release Tolterodine|"4 mg Tolterodine po daily for 12 weeks~At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks."
10881082|NCT00465894|FG001|Participant Flow|Group 2: Intra Vaginal Estradiol Cream|"0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks.~At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks"
10881083|NCT00465894|OG000|Outcome|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
10881084|NCT00465894|OG001|Outcome|Group 2: Intravaginal Estradiol Cream|0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
10881085|NCT00465894|OG000|Outcome|Extended Release Tolterodine|Tolterodine LA: Tolterodine LA 4 mg once daily for 52 weeks
10881086|NCT00465894|OG001|Outcome|Intravaginal Estradiol Cream|Estrace Intravaginal Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks
10881087|NCT00465894|OG000|Outcome|Extended Release Tolterodine LA|"An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.~Extended Release Tolterodine LA: Tolterodine LA 4 mg once daily for 52 weeks"
10881088|NCT00465894|OG001|Outcome|Intravaginal Estradiol Cream|"For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.~Intravaginal Estradiol Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks"
10881089|NCT00465894|OG000|Outcome|Group 1: Extended Release Tolterodine|"4 mg Tolterodine po daily for 12 weeks~At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks."
10881090|NCT00465894|OG001|Outcome|Group 2: Intravaginal Estradiol Cream|"0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks.~At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks"
11225251|NCT02366845|EG000|Reported Event|Clinician Chosen Dosing|"Usual Care arm: Physician determined FFP dosing. Bleeding patients admitted to study hospitals,with chronic liver disease determined to receive fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician. Total dose determined by physician's judgment (current standard of care). Physician chosen dose will be utilized but physician will be unaware of which dosing strategy utilized.~INR measurement will be performed within 1 hour after entire plasma transfusion administered. No other transfused blood component, crystalloid or colloidal fluid infused between first and second INR studies except plasma"
11225252|NCT02366845|EG001|Reported Event|Algorithm Dosing|"Intervention arm: Plasma transfusion dose determined using algorithm dosing table based on the pre-transfusion INR and clinician chosen INR target. Bleeding patients admitted to study hospitals with chronic liver disease determined to receive fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician.~Pre-transfusion INR and target post-transfusion INR used to determine FFP dose. The study table determines dose in (ml/kg) of FFP. INR measurement will be performed within 1 hour after entire plasma transfusion administered. No other transfused blood component,crystalloid or colloidal fluid will be infused between the first and second INR studies except plasma."
11225253|NCT02366871|BG000|Baseline|Oral Apixaban|"Oral apixaban 2.5 mg tablet twice daily for 28 days post-surgery~Oral apixaban: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery."
11225254|NCT02366871|BG001|Baseline|Subcutaneous Enoxaparin|"Subcutaneous enoxaparin 40mg once daily (QD) for 28 days post-surgery.~Subcutaneous enoxaparin: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery."
11225255|NCT02366871|BG002|Baseline|Total|Total of all reporting groups
11225256|NCT02366871|FG000|Participant Flow|Oral Apixaban|"Oral apixaban 2.5 mg tablet twice daily for 28 days post-surgery~Oral apixaban: To evaluate the incidence of major bleeding (including clinically relevant non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg twice a day (BID) compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery."
11225257|NCT02366871|FG001|Participant Flow|Subcutaneous Enoxaparin|"Subcutaneous enoxaparin 40mg once daily (QD) for 28 days post-surgery.~Subcutaneous enoxaparin: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery."
11225258|NCT02366871|OG000|Outcome|Oral Apixaban|"Oral apixaban 2.5 mg tablet twice daily for 28 days post-surgery~Oral apixaban: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery."
11225259|NCT02366871|OG001|Outcome|Subcutaneous Enoxaparin|"Subcutaneous enoxaparin 40mg once daily (QD) for 28 days post-surgery.~Subcutaneous enoxaparin: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery."
11225260|NCT02366871|EG000|Reported Event|Oral Apixaban|"Oral apixaban 2.5 mg tablet twice daily for 28 days post-surgery~Oral apixaban: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery."
11225261|NCT02366871|EG001|Reported Event|Subcutaneous Enoxaparin|"Subcutaneous enoxaparin 40mg once daily (QD) for 28 days post-surgery.~Subcutaneous enoxaparin: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery."
11225262|NCT02366910|BG000|Baseline|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
11225263|NCT02366910|FG000|Participant Flow|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
11225264|NCT02366910|OG000|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
11225265|NCT02366910|OG001|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
11225266|NCT02366910|EG000|Reported Event|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
11225267|NCT02366910|EG001|Reported Event|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
11225268|NCT02366923|BG000|Baseline|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
11342075|NCT03696576|OG001|Outcome|PhoRTE + EMST|"This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.~EMST: Training of the respiratory system muscles using the EMST device.~PhoRTE: Completing of PhoRTE voice therapy."
11225269|NCT02366923|FG000|Participant Flow|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
11225270|NCT02366923|OG000|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
11225271|NCT02366923|OG001|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
11225272|NCT02366923|EG000|Reported Event|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
11225273|NCT02366936|BG000|Baseline|Use of Tortle Midliner|"This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.~Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant's head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g."
10881091|NCT00465894|OG000|Outcome|Group 1: Extended Release Tolterodine + Intravaginal Estradiol|After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks.
11225274|NCT02366936|FG000|Participant Flow|Use of Tortle Midliner|"This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.~Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant's head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g."
11225275|NCT02366936|OG000|Outcome|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant's head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
11225276|NCT02366936|EG000|Reported Event|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant's head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
11225277|NCT02367014|BG000|Baseline|Low Dose|MTP-131: MTP-131 (low dose) administered as single day intravenous infusion over 2 hours for 5 days
11225278|NCT02367014|BG001|Baseline|Intermediate Dose|MTP-131: MTP-131 (intermediate dose) administered as single day intravenous infusion over 2 hours for 5 days
10881092|NCT00465894|OG001|Outcome|Group 2: Intravaginal Estradiol Cream + Tolterodine|"0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks + 4 mg Tolterodine daily~(At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.)"
10881093|NCT00465894|OG000|Outcome|Group 1: Extended Release Tolterodine + Intravaginal Estradiol|After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy . They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks.
10881094|NCT00465894|OG001|Outcome|Group 2: Intravaginal Estradiol Cream + Tolterodine|"0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks + 4 mg Tolterodine daily~(After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy.)"
10881095|NCT00465894|OG000|Outcome|Group 1: Extended Release Tolterodine + Intravaginal Estradiol|After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks
10881096|NCT00465894|OG001|Outcome|Group 2: Intravaginal Estradiol Cream + Tolterodine|"0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks+ 4 mg Tolterodine daily~(After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy.)"
10881097|NCT00465894|OG000|Outcome|Group 1: Extended Release Tolterodine + Intravaginal Estradiol|After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks
10881098|NCT00465894|OG001|Outcome|Intravaginal Estradiol Cream + Tolterodine|"Intravaginal estradiol Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks+ 4 mg Tolterodine daily~At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks."
10881099|NCT00465894|OG000|Outcome|Group 1: Extended Release Tolterodine + Intravaginal Estradiol|After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks.
10881100|NCT00465894|OG001|Outcome|Group 2: Intravaginal Estradiol Cream|"0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks.~At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks"
10881101|NCT00465894|EG000|Reported Event|Group 1: Extended Release Tolterodine|"4 mg Tolterodine po daily for 12-weeks~At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks."
10881102|NCT00465894|EG001|Reported Event|Group 2: Intra Vaginal Estradiol Cream|"0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks~At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks."
10881103|NCT00465972|BG000|Baseline|Placebo|1 sugar pill taken nightly at bedtime.
10881104|NCT00465972|BG001|Baseline|Temazepam|1 15 mg pill taken nightly at bedtime.
10881105|NCT00465972|BG002|Baseline|Total|Total of all reporting groups
10881106|NCT00465972|FG000|Participant Flow|Placebo|One sugar pill taken orally at bedtime for duration of the participant's involvement.
10881107|NCT00465972|FG001|Participant Flow|Temazepam|One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement.
10881108|NCT00465972|OG000|Outcome|Placebo|1 sugar pill taken orally at bedtime.
10881109|NCT00465972|OG001|Outcome|Temazepam|1 15 mg pill of temazepam taken orally at bedtime.
10881110|NCT00465972|OG000|Outcome|Placebo|1 sugar taken nightly at bedtime.
10881111|NCT00465972|OG001|Outcome|Temazepam|1 15 mg pill taken nightly at bedtime.
10881112|NCT00465972|EG000|Reported Event|Placebo|1 sugar pill taken nightly at bedtime.
10881113|NCT00465972|EG001|Reported Event|Temazepam|1 15 mg pill taken orally, nightly, at bedtime.
10881114|NCT00465985|BG000|Baseline|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
10881115|NCT00465985|FG000|Participant Flow|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
10881116|NCT00465985|FG001|Participant Flow|Placebo|Placebo subcutaneous injection every 8 weeks.
10881117|NCT00465985|OG000|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
10881118|NCT00465985|OG001|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
10881119|NCT00465985|EG000|Reported Event|Part I ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
10881120|NCT00465985|EG001|Reported Event|Part II ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
11225279|NCT02367014|BG002|Baseline|High Dose|MTP-131: MTP-131 (high dose) administered as single day intravenous infusion over 2 hours for 5 days
10881121|NCT00465985|EG002|Reported Event|Part II Placebo|Placebo subcutaneous injection every 8 weeks.
10881122|NCT00465985|EG003|Reported Event|Part III ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
10881123|NCT00465985|EG004|Reported Event|Entire Study ACZ885|Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
10881124|NCT00465998|BG000|Baseline|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
10881125|NCT00465998|FG000|Participant Flow|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
10881126|NCT00465998|OG000|Outcome|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
10881127|NCT00465998|OG000|Outcome|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
11225280|NCT02367014|BG003|Baseline|Placebo|Placebo: Placebo Comparator (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days
11348855|NCT04143373|OG000|Outcome|Room Temperature Saline of 25 ± 2 ° C|"In this study, during impacted mandibular third molar surgery, within each individual, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side of the same individual, was irrigated with normal saline of 37 ± 1 ° C as for the experimental side.~Within each individual, the left or right sides were allocated randomly for receiving these two types of saline."
11146971|NCT01855828|OG000|Outcome|Chemo Plus Pertuzumab,Trastuzumab-symptomatic Congestive Heart|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
11150104|NCT01875783|OG000|Outcome|Retina Specialist Care|Percentage of participants who follow-up with a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm as compared with the percentage of patients currently receiving retina eye care (assessed by study participant self-report as well as by determination of historical retina eye care rates from documentation in the medical records of study-eligible patients seen within the previous 6 months)
11225281|NCT02367014|BG004|Baseline|Total|Total of all reporting groups
10850965|NCT03410992|EG002|Reported Event|Placebo/Placebo (WK16ResS)|Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).
11150105|NCT01875783|OG000|Outcome|Eyes That Have Undergone OCT Imaging|"All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.~OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina."
11150106|NCT01875783|OG000|Outcome|Participants Referred for Retina Care|Study participants identified for retina referral by the OCT guided referral algorithm.
11225282|NCT02367014|FG000|Participant Flow|Low Dose|MTP-131: MTP-131 (low dose) 0.01 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10850966|NCT03410992|EG003|Reported Event|Bimekizumab 320 mg Q4W/Placebo (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
10881128|NCT00465998|EG000|Reported Event|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
10881129|NCT00466167|BG000|Baseline|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
10881130|NCT00466167|BG001|Baseline|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
10881131|NCT00466167|BG002|Baseline|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
10881132|NCT00466167|BG003|Baseline|Total|Total of all reporting groups
10881133|NCT00466167|FG000|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
10881134|NCT00466167|FG001|Participant Flow|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
10881135|NCT00466167|FG002|Participant Flow|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
10881136|NCT00466167|OG000|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
10881137|NCT00466167|OG001|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
10881138|NCT00466167|OG002|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
11150107|NCT01875783|EG000|Reported Event|OCT Imaging|"All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.~OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina."
10881139|NCT00466167|EG000|Reported Event|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
10881140|NCT00466167|EG001|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
10881141|NCT00466167|EG002|Reported Event|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
10881142|NCT00466193|BG000|Baseline|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
10881143|NCT00466193|BG001|Baseline|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
10881144|NCT00466193|BG002|Baseline|Total|Total of all reporting groups
10881145|NCT00466193|FG000|Participant Flow|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
10881146|NCT00466193|FG001|Participant Flow|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
10881147|NCT00466193|OG000|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
10881148|NCT00466193|OG001|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
10881149|NCT00466193|EG000|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
10881150|NCT00466193|EG001|Reported Event|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
11150108|NCT01875848|BG000|Baseline|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
10881151|NCT00466206|BG000|Baseline|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
10881152|NCT00466206|FG000|Participant Flow|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
10881153|NCT00466206|OG000|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
10881154|NCT00466206|OG000|Outcome|Treatment Arm|Magnetic Mini-Mover Procedure
10881155|NCT00466206|OG000|Outcome|3MP Treatment Group|Treatment of pectus excavatum with the Magnetic Mini-Mover Procedure
10881156|NCT00466206|OG000|Outcome|3MP Treatment Arm|Pectus excavatum treated with Magnetic Mini-Mover Procedure. Active treatment = 18 months
11146972|NCT01855828|OG001|Outcome|Chemo Plus Pertuzumab,Trastuzumab-asympomatic Decrease in LVEF|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
10881157|NCT00466206|EG000|Reported Event|Magnetic Mini-Mover Treatment|Use of the Magnimplant and Magnatract to treat pectus excavatum
10881158|NCT00466310|BG000|Baseline|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
10881159|NCT00466310|BG001|Baseline|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
10881160|NCT00466310|BG002|Baseline|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
10881161|NCT00466310|BG003|Baseline|Total|Total of all reporting groups
10881162|NCT00466310|FG000|Participant Flow|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
10881163|NCT00466310|FG001|Participant Flow|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
10881164|NCT00466310|FG002|Participant Flow|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
10881165|NCT00466310|OG000|Outcome|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
10881166|NCT00466310|OG001|Outcome|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
10881167|NCT00466310|OG002|Outcome|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
10881168|NCT00466310|EG000|Reported Event|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
10881169|NCT00466310|EG001|Reported Event|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
10881170|NCT00466310|EG002|Reported Event|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
10881171|NCT00466323|BG000|Baseline|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
10881172|NCT00466323|BG001|Baseline|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
10881173|NCT00466323|BG002|Baseline|Total|Total of all reporting groups
10881174|NCT00466323|FG000|Participant Flow|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
10881175|NCT00466323|FG001|Participant Flow|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
10881176|NCT00466323|OG000|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
10881177|NCT00466323|OG001|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
10881178|NCT00466323|EG000|Reported Event|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
10881179|NCT00466323|EG001|Reported Event|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
10881180|NCT00466440|BG000|Baseline|Part 1: Docetaxel + Prednisone + Enzastaurin|Participants were treated with modified Regimen A (modified investigational): docetaxel 75 mg/m2 IV given on Day 1 every 3 weeks and prednisone 5 mg po BID in combination with enzastaurin, starting loading dose on Day 4.
10881181|NCT00466440|BG001|Baseline|Part 2: Docetaxel + Prednisone + Enzastaurin|Regimen A: docetaxel 75 mg/m^2 IV given on Day 1 every 3 weeks and prednisone 5 mg po BID with enzastaurin, starting loading dose 1 day prior to chemotherapy.
10881182|NCT00466440|BG002|Baseline|Part 2: Docetaxel + Prednisone + Placebo|Regimen B: docetaxel 75 mg/m^2 IV is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po BID every day. In Cycle 1, placebo is given as a loading dose on the day prior to docetaxel and prednisone therapy, followed by placebo po QD for the remaining Period 2 (chemotherapy) and Period 3 (maintenance), until unblinding.
10881183|NCT00466440|BG003|Baseline|Total|Total of all reporting groups
10881184|NCT00466440|FG000|Participant Flow|Part 1: Docetaxel + Prednisone + Enzastaurin|Participants were treated with modified Regimen A (modified investigational): docetaxel 75 milligrams per square meter (mg/m^2), intravenous (IV) given on Day 1 every 3 weeks, and prednisone 5 milligrams (mg) oral (po), twice daily (BID) in combination with enzastaurin, starting loading dose on Day 4.
10881185|NCT00466440|FG001|Participant Flow|Part 2: Docetaxel + Prednisone + Enzastaurin|Regimen A: docetaxel 75 mg/m^2, IV given on Day 1 every 3 weeks and prednisone 5 mg po, BID with enzastaurin, starting loading dose 1 day prior to chemotherapy.
11150109|NCT01875848|BG001|Baseline|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
10881186|NCT00466440|FG002|Participant Flow|Part 2: Docetaxel + Prednisone + Placebo|Regimen B: docetaxel 75 mg/m^2, IV is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po, BID every day. In Cycle 1, placebo is given as a loading dose on the day prior to docetaxel and prednisone therapy, followed by placebo po, QD for the remaining Period 2 (chemotherapy) and Period 3 (maintenance), until unblinding.
10881187|NCT00466440|OG000|Outcome|Part 2: Docetaxel + Prednisone + Enzastaurin|Regimen A: docetaxel 75 mg/m^2 IV given on Day 1 every 3 weeks and prednisone 5 mg po BID with enzastaurin, starting loading dose 1 day prior to chemotherapy.
10881188|NCT00466440|OG001|Outcome|Part 2: Docetaxel + Prednisone + Placebo|Regimen B: docetaxel 75 mg/m^2 IV is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po BID every day. In Cycle 1, placebo is given as a loading dose on the day prior to docetaxel and prednisone therapy, followed by placebo po QD for the remaining Period 2 (chemotherapy) and Period 3 (maintenance), until unblinding.
10881189|NCT00466440|OG000|Outcome|Part 1: Docetaxel + Prednisone + Enzastaurin|Participants were treated with modified Regimen A (modified investigational): docetaxel 75 mg/m2 IV given on Day 1 every 3 weeks and prednisone 5 mg po BID in combination with enzastaurin, starting loading dose on Day 4.
10881190|NCT00466440|OG001|Outcome|Part 2: Docetaxel + Prednisone + Enzastaurin|Regimen A: docetaxel 75 mg/m^2 IV given on Day 1 every 3 weeks and prednisone 5 mg po BID with enzastaurin, starting loading dose 1 day prior to chemotherapy.
10881191|NCT00466440|OG002|Outcome|Part 2: Docetaxel + Prednisone + Placebo|Regimen B: docetaxel 75 mg/m^2 IV is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po BID every day. In Cycle 1, placebo is given as a loading dose on the day prior to docetaxel and prednisone therapy, followed by placebo po QD for the remaining Period 2 (chemotherapy) and Period 3 (maintenance), until unblinding.
10881192|NCT00466440|OG000|Outcome|Enzastaurin 500 mg QD Alone|Enzastaurin, LSN326020 and total analyte (enzastaurin + LSN326020) on Cycle 1 Day 21 (enzastaurin alone) following enzastaurin 500 mg oral (po) daily (QD).
10881193|NCT00466440|OG001|Outcome|Enzastaurin 500 mg QD + Docetaxel 75 mg/m^2 + Prednisone|Enzastaurin, LSN326020, and total analyte (enzastaurin + LSN326020) on Cycle 2 Day 1 (enzastaurin + docetaxel + prednisone) following enzastaurin 500 mg po QD.
10881194|NCT00466440|OG000|Outcome|Enzastaurin 500 mg QD Alone|Enzastaurin, LSN326020, and total analyte (enzastaurin + LSN326020) on Cycle 1 Day 21 (enzastaurin alone) following enzastaurin 500 mg oral (po) daily (QD).
10881195|NCT00466440|OG001|Outcome|Enzastaurin 500 mg QD+Docetaxel 75 mg/m^2+Prednisone (Part 1)|Enzastaurin, LSN326020, and total analyte (enzastaurin + LSN326020) on Cycle 2 Day 1 (enzastaurin + docetaxel + prednisone) following enzastaurin 500 mg po QD.
11146973|NCT01855828|OG002|Outcome|Chemo Plus Pertuzumab,Trastuzumab-LVEF Below Normal Level|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
10881196|NCT00466440|OG002|Outcome|Enzastaurin 500 mg QD+Docetaxel 75 mg/m^2+Prednisone (Part 2)|Enzastaurin, LSN326020, and total analyte (enzastaurin + LSN326020) on Cycle 2 Day 1 (enzastaurin + docetaxel + prednisone) following enzastaurin 500 mg po QD.
10881197|NCT00466440|OG000|Outcome|Docetaxel 75 mg/m^2 Alone|Docetaxel (75 mg/m^2) following 1.0 hour intravenous infusion on Cycle 1 Day 1 (Docetaxel + Prednisone).
10881198|NCT00466440|OG001|Outcome|Enzastaurin 500 mg QD + Docetaxel 75 mg/m^2 + Prednisone|Docetaxel (75 mg/m^2) following 1.0 hour intravenous infusion on Cycle 2 Day 1 (Docetaxel + Prednisone + Enzastaurin).
10881199|NCT00466440|EG000|Reported Event|Part 1: Docetaxel + Prednisone + Enzastaurin|Participants were treated with modified Regimen A (modified investigational): docetaxel 75 milligrams per square meter (mg/m^2), intravenous (IV) given on Day 1 every 3 weeks, and prednisone 5 milligrams (mg) oral (po), twice daily (BID) in combination with enzastaurin, starting loading dose on Day 4.
10881200|NCT00466440|EG001|Reported Event|Part 2: Docetaxel + Prednisone + Enzastaurin|Regimen A: docetaxel 75 mg/m^2, IV given on Day 1 every 3 weeks and prednisone 5 mg po, BID with enzastaurin, starting loading dose 1 day prior to chemotherapy.
10881201|NCT00466440|EG002|Reported Event|Part 2: Docetaxel + Prednisone + Placebo|Regimen B: docetaxel 75 mg/m^2, IV is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po, BID every day. In Cycle 1, placebo is given as a loading dose on the day prior to docetaxel and prednisone therapy, followed by placebo po, QD for the remaining Period 2 (chemotherapy) and Period 3 (maintenance), until unblinding.
10881202|NCT00466505|BG000|Baseline|Therapeutic Intervention|
10881203|NCT00466505|FG000|Participant Flow|Therapeutic Intervention|
10881204|NCT00466505|OG000|Outcome|Therapeutic Intervention|
10881205|NCT00466505|EG000|Reported Event|Therapeutic Intervention|
10881206|NCT00466661|BG000|Baseline|Acamprosate|666 mg p.o. TID
10881207|NCT00466661|BG001|Baseline|Placebo|Matching placebo
10881208|NCT00466661|BG002|Baseline|Total|Total of all reporting groups
10881209|NCT00466661|FG000|Participant Flow|Acamprosate|666 mg p.o. TID
10881210|NCT00466661|FG001|Participant Flow|Placebo|Matching placebo
10881211|NCT00466661|OG000|Outcome|Acamprosate|Participants assigned to acamprosate with at least one return visit after randomization
10881212|NCT00466661|OG001|Outcome|Placebo|Participants assigned to placebo who returned for at least one visit after randomization
10881213|NCT00466661|EG000|Reported Event|Acamprosate|Participants assigned to acamprosate
10881214|NCT00466661|EG001|Reported Event|Placebo|Participants assigned to placebo
10881215|NCT00466687|BG000|Baseline|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
10881216|NCT00466687|FG000|Participant Flow|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
10881217|NCT00466687|OG000|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
10881218|NCT00466687|OG000|Outcome|Therapeutic Intervention|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
10881219|NCT00466687|OG000|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
10881220|NCT00466687|EG000|Reported Event|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
10881221|NCT00466726|BG000|Baseline|Chronic Myeloid Leukemia (CML) Patients|Study population
10881222|NCT00466726|FG000|Participant Flow|Chronic Myeloid Leukemia (CML) Patients|Study population
10881223|NCT00466726|OG000|Outcome|Chronic Myeloid Leukemia (CML) Patients|Study population
10881224|NCT00466726|EG000|Reported Event|Chronic Myeloid Leukemia (CML) Patients|Study population
10881225|NCT00466752|BG000|Baseline|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
10881226|NCT00466752|BG001|Baseline|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
11150110|NCT01875848|BG002|Baseline|Total|Total of all reporting groups
10881227|NCT00466752|BG002|Baseline|Total|Total of all reporting groups
10881228|NCT00466752|FG000|Participant Flow|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
10881229|NCT00466752|FG001|Participant Flow|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
10881230|NCT00466752|OG000|Outcome|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
10881231|NCT00466752|OG001|Outcome|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
10881232|NCT00466752|EG000|Reported Event|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
10881233|NCT00466752|EG001|Reported Event|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
10881234|NCT00466817|BG000|Baseline|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
10881235|NCT00466817|BG001|Baseline|Valganciclovir: 24 Wks of Valganciclovir|"Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
10881236|NCT00466817|BG002|Baseline|Total|Total of all reporting groups
10881237|NCT00466817|FG000|Participant Flow|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
10881238|NCT00466817|FG001|Participant Flow|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
11150111|NCT01875848|FG000|Participant Flow|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
10881239|NCT00466817|OG000|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
10881240|NCT00466817|OG001|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
10881241|NCT00466817|OG001|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
11150112|NCT01875848|FG001|Participant Flow|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
10881242|NCT00466817|OG000|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
10881243|NCT00466817|OG001|Outcome|Valganciclovir: 24 Weeks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
10881244|NCT00466817|OG000|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
10881245|NCT00466817|OG001|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
10881246|NCT00466817|OG000|Outcome|Placebo: 6 Wks of Vlaganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
10881247|NCT00466817|OG000|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
10881248|NCT00466817|OG001|Outcome|Valganciclovir: 24 Wks of Vlaganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
10881249|NCT00466817|EG000|Reported Event|Non Randomized|6 weeks of open label valganciclovir only
10881250|NCT00466817|EG001|Reported Event|Active|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir
10881251|NCT00466817|EG002|Reported Event|Placebo After 6 Weeks of Valganciclovir|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo
10881252|NCT00466921|BG000|Baseline|Lenalidomide|lenalidomide: 25 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, or starting dose of 10mg increasing dose by 5 mg every cycle, up to a maximum of 25 mg.
10881253|NCT00466921|FG000|Participant Flow|Lenalidomide|lenalidomide: 25 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, or starting dose of 10mg increasing dose by 5 mg every cycle, up to a maximum of 25 mg.
10881254|NCT00466921|OG000|Outcome|Lenalidomide|lenalidomide: 25 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, or starting dose of 10mg increasing dose by 5 mg every cycle, up to a maximum of 25 mg.
10881255|NCT00466921|EG000|Reported Event|Lenalidomide|lenalidomide: 25 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, or starting dose of 10mg increasing dose by 5 mg every cycle, up to a maximum of 25 mg.
10881256|NCT00466947|BG000|Baseline|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
10881257|NCT00466947|BG001|Baseline|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
10881258|NCT00466947|BG002|Baseline|Total|Total of all reporting groups
10881259|NCT00466947|FG000|Participant Flow|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
10881260|NCT00466947|FG001|Participant Flow|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
10881261|NCT00466947|OG000|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
10881262|NCT00466947|OG001|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
10881263|NCT00466947|OG000|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
10881264|NCT00466947|EG000|Reported Event|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
10881265|NCT00466947|EG001|Reported Event|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
10881266|NCT00466960|BG000|Baseline|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
10881267|NCT00466960|FG000|Participant Flow|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
10881268|NCT00466960|OG000|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
10881269|NCT00466960|EG000|Reported Event|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
10881270|NCT00467038|BG000|Baseline|Dialectical Behavior Therapy|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD~Event-related fMRI was obtained pre- and post-12-months of standard-DBT in unmedicatedBPD patients."
10881271|NCT00467038|BG001|Baseline|Healthy Controls|"Healthy controls~Age and gender matched healthy volunteers"
10881272|NCT00467038|BG002|Baseline|Total|Total of all reporting groups
10881273|NCT00467038|FG000|Participant Flow|Dialectical Behavior Therapy|Participants receiving Dialectical Behavior Therapy
10881274|NCT00467038|FG001|Participant Flow|Healthy Controls|Healthy controls- no intervention
10881275|NCT00467038|OG000|Outcome|Dialectical Behavior Therapy|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
10881276|NCT00467038|OG001|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
10881277|NCT00467038|OG000|Outcome|Dialectical Behavior Therapy|Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
10881278|NCT00467038|EG000|Reported Event|Arm 1|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
10881279|NCT00467038|EG001|Reported Event|Arm 2|Healthy controls- no intervention
10881280|NCT00467051|BG000|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
11150113|NCT01875848|OG000|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
10881281|NCT00467051|FG000|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
10881282|NCT00467051|OG000|Outcome|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
10881283|NCT00467051|OG000|Outcome|Experimental|
10881284|NCT00467051|EG000|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
10881285|NCT00467077|BG000|Baseline|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
10881286|NCT00467077|FG000|Participant Flow|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
10881287|NCT00467077|OG000|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
10881288|NCT00467077|EG000|Reported Event|Arm 1|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
10881289|NCT00467259|BG000|Baseline|Placebo|Placebo patch
10881290|NCT00467259|BG001|Baseline|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
10881291|NCT00467259|BG002|Baseline|Total|Total of all reporting groups
10881292|NCT00467259|FG000|Participant Flow|Placebo|Placebo patch
10881293|NCT00467259|FG001|Participant Flow|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
10881294|NCT00467259|OG000|Outcome|Placebo|Placebo patch
10881295|NCT00467259|OG001|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
10881296|NCT00467259|EG000|Reported Event|Placebo|Placebo patch
10881297|NCT00467259|EG001|Reported Event|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
10881298|NCT00467272|BG000|Baseline|Daptomycin 6 mg/kg IV|Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
10881299|NCT00467272|FG000|Participant Flow|Daptomycin 6 mg/kg IV|Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
10881300|NCT00467272|OG000|Outcome|Daptomycin 6 mg/kg IV|Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
10881301|NCT00467272|EG000|Reported Event|Daptomycin 6 mg/kg IV|Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
10881302|NCT00467285|BG000|Baseline|Pioglitazone|32 subjects with type 2 diabetes on pioglitazone.
10881303|NCT00467285|BG001|Baseline|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
10881304|NCT00467285|BG002|Baseline|Total|Total of all reporting groups
10881305|NCT00467285|FG000|Participant Flow|Group 1|32 subjects with type 2 diabetes on pioglitazone.
10881306|NCT00467285|FG001|Participant Flow|Group 2|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
10881307|NCT00467285|OG000|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
10881308|NCT00467285|OG001|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
10881309|NCT00467285|OG000|Outcome|Baseline Characteristics: Group 1|Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
10881310|NCT00467285|OG001|Outcome|Baseline Characteristics: Group 2|Mean age of 49 with mean BMI 0f 35.2 ± 5; HbA1C of 7.45
10881311|NCT00467285|EG000|Reported Event|Pioglitazone|Subjects on pioglitazone
10881312|NCT00467285|EG001|Reported Event|No Pioglitazone|Subjects not on pioglitazone
10881313|NCT00467298|BG000|Baseline|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
10881314|NCT00467298|BG001|Baseline|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
11009779|NCT01104155|BG001|Baseline|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
10881315|NCT00467298|BG002|Baseline|Total|Total of all reporting groups
10881316|NCT00467298|FG000|Participant Flow|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
11009780|NCT01104155|BG002|Baseline|Total|Total of all reporting groups
11009781|NCT01104155|FG000|Participant Flow|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
11009782|NCT01104155|FG001|Participant Flow|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
11009783|NCT01104155|OG000|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
11009784|NCT01104155|OG001|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
11009785|NCT01104155|EG000|Reported Event|Eribulin Mesylate, 21 Day Cycle|Eribulin mesylate + Erlotinib: 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
11150114|NCT01875848|OG001|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
10881317|NCT00467298|FG001|Participant Flow|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
10881318|NCT00467298|OG000|Outcome|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
10881319|NCT00467298|OG001|Outcome|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
10881320|NCT00467298|EG000|Reported Event|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
10881321|NCT00467298|EG001|Reported Event|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
10881322|NCT00467350|BG000|Baseline|Enema|"Rectal enema containing mixture of milk and molasses~milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance"
10881323|NCT00467350|BG001|Baseline|PEG 3350|"Medication to be taken orally once each day for three consecutive days~PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance"
10881324|NCT00467350|BG002|Baseline|Total|Total of all reporting groups
10881325|NCT00467350|FG000|Participant Flow|Enema|milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
10881326|NCT00467350|FG001|Participant Flow|PEG 3350|PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
10881327|NCT00467350|OG000|Outcome|Enema|milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
10881328|NCT00467350|OG001|Outcome|PEG 3350|PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
10881329|NCT00467350|EG000|Reported Event|Enema|milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
10881330|NCT00467350|EG001|Reported Event|PEG 3350|PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
10881331|NCT00467363|BG000|Baseline|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
11348856|NCT04143373|OG001|Outcome|Warm Saline of 37 ± 1 ° C|"In this study, during impacted mandibular third molar surgery, within each individual, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side of the same individual, was irrigated with normal saline of 37 ± 1 ° C as for the experimental side.~Within each individual, the left or right sides were allocated randomly for receiving these two types of saline."
10881332|NCT00467363|BG001|Baseline|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
10881333|NCT00467363|BG002|Baseline|Total|Total of all reporting groups
10881334|NCT00467363|FG000|Participant Flow|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
10881335|NCT00467363|FG001|Participant Flow|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
10881336|NCT00467363|OG000|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
10881337|NCT00467363|OG001|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
10881338|NCT00467363|EG000|Reported Event|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
10881339|NCT00467363|EG001|Reported Event|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
10881340|NCT00467389|BG000|Baseline|All Participants|All recruited subjects
10881341|NCT00467389|FG000|Participant Flow|Placebo Treatment First|Participants initially treated with oral placebo, and later treated with oral donepezil
10881342|NCT00467389|FG001|Participant Flow|Donepezil Treatment First|Participants initially treated with oral donepezil, and later treated with oral placebo
10881343|NCT00467389|OG000|Outcome|Placebo Treatment Period|Inactive Comparator
10881344|NCT00467389|OG001|Outcome|Donepezil Treatment Period|Active Treatment
10881345|NCT00467389|EG000|Reported Event|Placebo Treatment Period|Inactive Comparator.
10881346|NCT00467389|EG001|Reported Event|Donepezil Treatment Period|Active Treatment
10881347|NCT00467519|BG000|Baseline|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
10881348|NCT00467519|BG001|Baseline|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
10881349|NCT00467519|BG002|Baseline|Total|Total of all reporting groups
10881350|NCT00467519|FG000|Participant Flow|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
10881351|NCT00467519|FG001|Participant Flow|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
10881352|NCT00467519|OG000|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
10881353|NCT00467519|OG001|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
10881354|NCT00467519|EG000|Reported Event|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
10881355|NCT00467519|EG001|Reported Event|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
10881356|NCT00467558|BG000|Baseline|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
10881357|NCT00467558|BG001|Baseline|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
10881358|NCT00467558|BG002|Baseline|Total|Total of all reporting groups
10881359|NCT00467558|FG000|Participant Flow|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
10881360|NCT00467558|FG001|Participant Flow|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
10881361|NCT00467558|OG000|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
10881362|NCT00467558|OG001|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
10881363|NCT00467558|EG000|Reported Event|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
10881364|NCT00467558|EG001|Reported Event|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
10881365|NCT00467584|BG000|Baseline|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
10881366|NCT00467584|BG001|Baseline|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
10881367|NCT00467584|BG002|Baseline|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
10881368|NCT00467584|BG003|Baseline|Total|Total of all reporting groups
10881369|NCT00467584|FG000|Participant Flow|High Dose Aspirin|"High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks~High Dose Aspirin (1300 mg/day): 1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
10881370|NCT00467584|FG001|Participant Flow|Low Dose Aspirin|"Low Dose Aspirin; 162 milligrams of aspirin per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks~Low Dose Aspirin (162 mg/day): 162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
10881371|NCT00467584|FG002|Participant Flow|Placebo|"Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks~Placebo: Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks"
10881372|NCT00467584|OG000|Outcome|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
10881373|NCT00467584|OG001|Outcome|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
10881374|NCT00467584|OG002|Outcome|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
10881375|NCT00467584|EG000|Reported Event|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
10881376|NCT00467584|EG001|Reported Event|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
10881377|NCT00467584|EG002|Reported Event|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
10881378|NCT00467597|BG000|Baseline|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
10881379|NCT00467597|BG001|Baseline|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
10881380|NCT00467597|BG002|Baseline|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
10881381|NCT00467597|BG003|Baseline|Controls - No PD|Controls with no Parkinson's disease
10881382|NCT00467597|BG004|Baseline|Total|Total of all reporting groups
10881383|NCT00467597|FG000|Participant Flow|Parkinson's Disease|Parkinson's disease with and without Levodopa-Induced Dyskinesia (no intervention).
10881384|NCT00467597|FG001|Participant Flow|Controls|Non-Parkinson's Disease Controls (no intervention).
10881385|NCT00467597|OG000|Outcome|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
10881386|NCT00467597|OG001|Outcome|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
10881387|NCT00467597|OG002|Outcome|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
10881388|NCT00467597|OG003|Outcome|Controls - No PD|Controls with no Parkinson's disease
10881389|NCT00467597|EG000|Reported Event|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
10881390|NCT00467597|EG001|Reported Event|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
10881391|NCT00467597|EG002|Reported Event|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
10881392|NCT00467597|EG003|Reported Event|Controls - No PD|Controls with no Parkinson's disease
11150115|NCT01875848|EG000|Reported Event|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
10881393|NCT00467610|BG000|Baseline|Group 1|Panhematin treatment arm
10881394|NCT00467610|FG000|Participant Flow|Group 1|Panhematin treatment arm
10881395|NCT00467610|OG000|Outcome|Group 1|Panhematin treatment arm
10881396|NCT00467610|EG000|Reported Event|Group 1|Panhematin treatment arm
10881397|NCT00467649|BG000|Baseline|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
10881398|NCT00467649|BG001|Baseline|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
10881399|NCT00467649|BG002|Baseline|Total|Total of all reporting groups
10881400|NCT00467649|FG000|Participant Flow|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
10881401|NCT00467649|FG001|Participant Flow|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
10881402|NCT00467649|FG002|Participant Flow|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
10881403|NCT00467649|FG003|Participant Flow|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
10881404|NCT00467649|FG004|Participant Flow|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
10881405|NCT00467649|FG005|Participant Flow|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
10881406|NCT00467649|OG000|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
10881407|NCT00467649|OG001|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
10881408|NCT00467649|OG000|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
10881409|NCT00467649|OG001|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
10881410|NCT00467649|OG002|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
10881411|NCT00467649|OG003|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
10881412|NCT00467649|OG002|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
10881413|NCT00467649|OG003|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
10881414|NCT00467649|OG004|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
10881415|NCT00467649|OG005|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
10881416|NCT00467649|EG000|Reported Event|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
10881417|NCT00467649|EG001|Reported Event|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
10881418|NCT00467649|EG002|Reported Event|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
10881419|NCT00467649|EG003|Reported Event|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
10881420|NCT00467649|EG004|Reported Event|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
10881421|NCT00467649|EG005|Reported Event|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
10881422|NCT00467740|BG000|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10881423|NCT00467740|BG001|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10881424|NCT00467740|BG002|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10881425|NCT00467740|BG003|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10881426|NCT00467740|BG004|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
10881427|NCT00467740|BG005|Baseline|Total|Total of all reporting groups
10881428|NCT00467740|FG000|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10881429|NCT00467740|FG001|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10881430|NCT00467740|FG002|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10881431|NCT00467740|FG003|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10881432|NCT00467740|FG004|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
10881433|NCT00467740|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10881434|NCT00467740|OG001|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10881435|NCT00467740|OG002|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10881436|NCT00467740|OG003|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10881437|NCT00467740|OG004|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
10881438|NCT00467740|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10881439|NCT00467740|EG001|Reported Event|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10881440|NCT00467740|EG002|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10881441|NCT00467740|EG003|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10881442|NCT00467740|EG004|Reported Event|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
10881443|NCT00467779|BG000|Baseline|Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881444|NCT00467779|BG001|Baseline|Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881445|NCT00467779|BG002|Baseline|Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881446|NCT00467779|BG003|Baseline|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881447|NCT00467779|BG004|Baseline|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881448|NCT00467779|BG005|Baseline|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881449|NCT00467779|BG006|Baseline|Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881450|NCT00467779|BG007|Baseline|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881451|NCT00467779|BG008|Baseline|Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881452|NCT00467779|BG009|Baseline|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881453|NCT00467779|BG010|Baseline|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881454|NCT00467779|BG011|Baseline|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881455|NCT00467779|BG012|Baseline|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881456|NCT00467779|BG013|Baseline|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881457|NCT00467779|BG014|Baseline|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
10881458|NCT00467779|BG015|Baseline|Total|Total of all reporting groups
10881459|NCT00467779|FG000|Participant Flow|Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 milligrams per kilograms (mg/kg) via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881460|NCT00467779|FG001|Participant Flow|Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881461|NCT00467779|FG002|Participant Flow|Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881462|NCT00467779|FG003|Participant Flow|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881463|NCT00467779|FG004|Participant Flow|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881464|NCT00467779|FG005|Participant Flow|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881465|NCT00467779|FG006|Participant Flow|Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881466|NCT00467779|FG007|Participant Flow|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
11009786|NCT01104155|EG001|Reported Event|Eribulin Mesylate, 28 Day Cycle|Eribulin mesylate + Erlotinib: 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
10881467|NCT00467779|FG008|Participant Flow|Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881468|NCT00467779|FG009|Participant Flow|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881469|NCT00467779|FG010|Participant Flow|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881470|NCT00467779|FG011|Participant Flow|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
11348857|NCT04143373|EG000|Reported Event|All Study Participants|"In this study, during impacted mandibular third molar surgery, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side was irrigated with normal saline of 37 ± 1 ° C as for the experimental side.~The side for each intervention was determined by a table of random numbers."
10881471|NCT00467779|FG012|Participant Flow|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881472|NCT00467779|FG013|Participant Flow|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
11009787|NCT01104207|BG000|Baseline|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
10881473|NCT00467779|FG014|Participant Flow|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
10881474|NCT00467779|OG000|Outcome|Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881475|NCT00467779|OG001|Outcome|Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881476|NCT00467779|OG002|Outcome|Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881477|NCT00467779|OG003|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881478|NCT00467779|OG004|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881479|NCT00467779|OG005|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881480|NCT00467779|OG006|Outcome|Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881481|NCT00467779|OG007|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
11009788|NCT01104207|BG001|Baseline|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
11009789|NCT01104207|BG002|Baseline|Total|Total of all reporting groups
11150116|NCT01875848|EG001|Reported Event|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
10881482|NCT00467779|OG008|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881483|NCT00467779|OG009|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881484|NCT00467779|OG010|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881485|NCT00467779|OG011|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881486|NCT00467779|OG000|Outcome|Stage 1 All Cohorts (21/7)|Participants received cobimetinib via solution or capsule, once daily for Days 1-21 of each 28-day cycle and were on 21-days-on and 7-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881487|NCT00467779|OG000|Outcome|Stage 1A - All Cohorts (14/14)|Participants received cobimetinib via solution or capsule, once daily for Days 1-14 of each 28-day cycle and were on a 14-days-on and 14-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881488|NCT00467779|OG000|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881489|NCT00467779|OG001|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881490|NCT00467779|OG002|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881491|NCT00467779|OG003|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881492|NCT00467779|OG000|Outcome|Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881493|NCT00467779|OG000|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881494|NCT00467779|OG000|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
10881495|NCT00467779|EG000|Reported Event|Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881496|NCT00467779|EG001|Reported Event|Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881497|NCT00467779|EG002|Reported Event|Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881498|NCT00467779|EG003|Reported Event|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881499|NCT00467779|EG004|Reported Event|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
11225283|NCT02367014|FG001|Participant Flow|Intermediate Dose|MTP-131: MTP-131 (intermediate dose) 0.10 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
11225284|NCT02367014|FG002|Participant Flow|High Dose|MTP-131: MTP-131 (high dose) 0.25 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10881500|NCT00467779|EG005|Reported Event|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881501|NCT00467779|EG006|Reported Event|Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881502|NCT00467779|EG007|Reported Event|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881503|NCT00467779|EG008|Reported Event|Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881504|NCT00467779|EG009|Reported Event|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881505|NCT00467779|EG010|Reported Event|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881506|NCT00467779|EG011|Reported Event|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881507|NCT00467779|EG012|Reported Event|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881508|NCT00467779|EG013|Reported Event|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
10881509|NCT00467779|EG014|Reported Event|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period. Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
11225285|NCT02367014|FG003|Participant Flow|Placebo|Placebo: Placebo Comparator (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days
10881510|NCT00467818|BG000|Baseline|Omega 3 Fatty Acids, Drug|"Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.~Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly."
10881511|NCT00467818|BG001|Baseline|Placebo|"The placebo will be dispensed to subjects in the control group~Placebo : Same dosage as that of omega 3 fatty acids"
10881512|NCT00467818|BG002|Baseline|Total|Total of all reporting groups
10881513|NCT00467818|FG000|Participant Flow|Omega 3 Fatty Acids, Drug|"Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.~Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly."
10881514|NCT00467818|FG001|Participant Flow|Placebo|"The placebo will be dispensed to subjects in the control group~Placebo : Same dosage as that of omega 3 fatty acids"
10881515|NCT00467818|OG000|Outcome|Omega 3 Fatty Acids, Drug|"Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.~Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly."
10881516|NCT00467818|OG001|Outcome|Placebo|"The placebo will be dispensed to subjects in the control group~Placebo : Same dosage as that of omega 3 fatty acids"
10881517|NCT00467818|OG000|Outcome|Omega 3 Fatty Acids, Drug|"Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.~Omega 3 fatty acids: The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly."
10881518|NCT00467818|OG001|Outcome|Placebo|"The placebo will be dispensed to subjects in the control group~Placebo: Same dosage as that of omega 3 fatty acids"
10881519|NCT00467818|EG000|Reported Event|Omega 3 Fatty Acids, Drug|"Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.~Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly."
10881520|NCT00467818|EG001|Reported Event|Placebo|"The placebo will be dispensed to subjects in the control group~Placebo : Same dosage as that of omega 3 fatty acids"
10887298|NCT00499655|FG001|Participant Flow|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
11225286|NCT02367014|OG000|Outcome|Low Dose|MTP-131 (low dose) 0.01 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10881521|NCT00467831|BG000|Baseline|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
10881522|NCT00467831|FG000|Participant Flow|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
10881523|NCT00467831|OG000|Outcome|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
10881524|NCT00467831|EG000|Reported Event|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
10881525|NCT00467844|BG000|Baseline|GTx -024|1 mg
10881526|NCT00467844|BG001|Baseline|GTx-024|3 mg
10881527|NCT00467844|BG002|Baseline|3 mg of Placebo|Placebo
10881528|NCT00467844|BG003|Baseline|Total|Total of all reporting groups
10881529|NCT00467844|FG000|Participant Flow|GTx -024|1 mg
10881530|NCT00467844|FG001|Participant Flow|GTx-024|3 mg
11146974|NCT01855828|OG000|Outcome|Chemo Plus Pertuzumab,Trastuzumab HR-positive|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
11225287|NCT02367014|OG001|Outcome|Intermediate Dose|MTP-131 (intermediate dose) 0.10 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10881531|NCT00467844|FG002|Participant Flow|3 mg of Placebo|Placebo
10881532|NCT00467844|OG000|Outcome|GTx-024 1 mg|
10881533|NCT00467844|OG001|Outcome|GTx-024 3 mg|
10881534|NCT00467844|OG002|Outcome|Placebo|Placebo
10881535|NCT00467844|OG000|Outcome|GTx -024|1 mg
10881536|NCT00467844|OG001|Outcome|GTx-024|3 mg
10881537|NCT00467844|OG002|Outcome|3 mg of Placebo|Placebo
10881538|NCT00467844|EG000|Reported Event|GTx -024|1 mg
10881539|NCT00467844|EG001|Reported Event|GTx-024|3 mg
10881540|NCT00467844|EG002|Reported Event|3 mg of Placebo|Placebo
10881541|NCT00467857|BG000|Baseline|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
10881542|NCT00467857|BG001|Baseline|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
10881543|NCT00467857|BG002|Baseline|Total|Total of all reporting groups
10881544|NCT00467857|FG000|Participant Flow|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
10881545|NCT00467857|FG001|Participant Flow|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
10881546|NCT00467857|OG000|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
10881547|NCT00467857|OG001|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
10881548|NCT00467857|EG000|Reported Event|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
10881549|NCT00467857|EG001|Reported Event|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
10881550|NCT00467870|BG000|Baseline|A-TU 750 mg|750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A
10881551|NCT00467870|BG001|Baseline|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
10881552|NCT00467870|BG002|Baseline|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
10881553|NCT00467870|BG003|Baseline|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
10881554|NCT00467870|BG004|Baseline|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
10881555|NCT00467870|BG005|Baseline|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
10881556|NCT00467870|BG006|Baseline|Total|Total of all reporting groups
10881557|NCT00467870|FG000|Participant Flow|A-TU 750 mg|750 mg testosterone undecanoate (TU) in 3 mL oily solution, intramuscularly (IM) every 12 weeks for up to 3 years in Part A
10881558|NCT00467870|FG001|Participant Flow|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
10881559|NCT00467870|FG002|Participant Flow|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
11009790|NCT01104207|FG000|Participant Flow|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
10881560|NCT00467870|FG003|Participant Flow|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
10881561|NCT00467870|FG004|Participant Flow|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
10881562|NCT00467870|FG005|Participant Flow|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
10881563|NCT00467870|OG000|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
10881564|NCT00467870|OG000|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
10881565|NCT00467870|OG000|Outcome|A-TU 750 mg|750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A
10881566|NCT00467870|OG001|Outcome|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
10881567|NCT00467870|OG000|Outcome|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
10881568|NCT00467870|OG001|Outcome|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
10881569|NCT00467870|EG000|Reported Event|TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline and during the study in Part A, C, or C2 (includes participants from A-750 mg, C-750 mg, and C2-750 mg)
10881570|NCT00467870|EG001|Reported Event|TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at any time during the study in Part A or B (includes participants from A-1000 mg, B-750 mg, and B-1000 mg)
10881571|NCT00467896|BG000|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
10881572|NCT00467896|FG000|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
10881573|NCT00467896|OG000|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
10881574|NCT00467896|OG000|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
10881575|NCT00467896|OG000|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) in Period I and Power Disc-15 (PD-15)in Period II.
10881576|NCT00467896|EG000|Reported Event|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
11009791|NCT01104207|FG001|Participant Flow|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
11009792|NCT01104207|OG000|Outcome|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
10881577|NCT00467961|BG000|Baseline|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
10881578|NCT00467961|FG000|Participant Flow|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
10881579|NCT00467961|OG000|Outcome|Selective T Cell Depletion Transplant Recipients|"Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach (Kiadis Pharma). Older subjects will receive a lower dose of irradiation to reduce the regimen intensity.~To determine appropriate level of post transplant immunosuppression."
10881580|NCT00467961|EG000|Reported Event|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
10881581|NCT00468052|BG000|Baseline|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
10881582|NCT00468052|BG001|Baseline|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
10881583|NCT00468052|BG002|Baseline|Total|Total of all reporting groups
10881584|NCT00468052|FG000|Participant Flow|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
10881585|NCT00468052|FG001|Participant Flow|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
11146975|NCT01855828|OG001|Outcome|Chemo Plus Pertuzumab,Trastuzumab HR-negative|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
11146976|NCT01855828|EG000|Reported Event|Chemo Plus Pertuzumab,Trastuzumab|"During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).~Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)~Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).~Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).~5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).~Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).~Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total)."
11348858|NCT04142216|BG000|Baseline|Chewing Gum Group|"The patients will be asked to chew on a regular chewing gum for three months.~Chewing Gum: The patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months."
10881586|NCT00468052|OG000|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
10881587|NCT00468052|OG001|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
10881588|NCT00468052|OG000|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
10881589|NCT00468052|OG001|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
10881590|NCT00468052|EG000|Reported Event|Fentanyl (F) Group|"No subjects in group F experienced an adverse event.~0"
10881591|NCT00468052|EG001|Reported Event|Dexmedetomidine|1 subjects Group D experienced an adverse event.
10881592|NCT00468104|BG000|Baseline|Alteplase; Placebo|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally; 100 cc of normal saline instilled intrapleurally
10881593|NCT00468104|FG000|Participant Flow|Alteplase Then Placebo|25 mg of Alteplase in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Placebo)
10881594|NCT00468104|FG001|Participant Flow|Placebo Then Alteplase|Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Alteplase)
10881595|NCT00468104|OG000|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline given intrapleurally daily for 3 days either in the first or second arm
10881596|NCT00468104|OG001|Outcome|Placebo|Placebo in 100 cc of normal saline given daily intrapleurally for 3 days either in the first or second arm
10881597|NCT00468104|OG000|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
10881598|NCT00468104|OG001|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
10881599|NCT00468104|EG000|Reported Event|Received Alteplase Only|These patients received only Alteplase and were not crossed over
10881600|NCT00468104|EG001|Reported Event|Received Placebo Only|These patients received Placebo only and were not crossed over
10881601|NCT00468104|EG002|Reported Event|Received Both Alteplase and Placebo|These patients were crossed over and received both Alteplase and Placebo
11009793|NCT01104207|OG001|Outcome|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
10881602|NCT00468143|BG000|Baseline|All Participants|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
10881603|NCT00468143|FG000|Participant Flow|Extended Release First|This group received the extended release medication during the first three weeks of treatment and then received the immediate release medication during the last 3 weeks of treatment.
10881604|NCT00468143|FG001|Participant Flow|Immediate Release First|This group received the immediate release medication during the first three weeks of treatment and then received the extended release medication during the last 3 weeks of treatment.
10881605|NCT00468143|OG000|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
10881606|NCT00468143|OG001|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
10881607|NCT00468143|EG000|Reported Event|Extended Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
10881608|NCT00468143|EG001|Reported Event|Immediate Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
10881609|NCT00468169|BG000|Baseline|A: Cetuximab+FHX|"Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)"
10881610|NCT00468169|BG001|Baseline|B: Cetuximab + PX|"Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)"
10881611|NCT00468169|BG002|Baseline|Total|Total of all reporting groups
10881612|NCT00468169|FG000|Participant Flow|A: Cetuximab+FHX|"Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)"
10881613|NCT00468169|FG001|Participant Flow|B: Cetuximab + PX|"Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)"
10881614|NCT00468169|OG000|Outcome|A: Cetuximab+FHX|"Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)"
10881615|NCT00468169|OG001|Outcome|B: Cetuximab + PX|"Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)"
10881616|NCT00468169|OG000|Outcome|A: Cetuximab+FHX|"Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks.~Cetuximab: 250mg/m2(day 1, weekly x 10);~5-FU: 600 mg/m2/day; days 0-5 (120 h total) every other week x 5~Hydroxyurea: 500 mg PO BID, days 0-5 every other week x 5~Twice-daily radiation: 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)"
10881617|NCT00468169|OG001|Outcome|B: Cetuximab + PX|"Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks.~Cetuximab: 250mg/m2(day 1, weekly x 10);~Cisplatin: 100 mg/m2, week 1 and 4 on day 1 (or 2)~Accelerated fraction radiotherapy with concomitant boost: 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks."
11009794|NCT01104207|EG000|Reported Event|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
11009795|NCT01104207|EG001|Reported Event|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
11146977|NCT01855919|BG000|Baseline|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
11146978|NCT01855919|BG001|Baseline|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
10881618|NCT00468169|EG000|Reported Event|A: Cetuximab+FHX|"Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)"
10881619|NCT00468169|EG001|Reported Event|B: Cetuximab + PX|"Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)"
10881620|NCT00468208|BG000|Baseline|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
10881621|NCT00468208|FG000|Participant Flow|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
10881622|NCT00468208|OG000|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
10881623|NCT00468208|EG000|Reported Event|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
10881624|NCT00468286|BG000|Baseline|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
10881625|NCT00468286|BG001|Baseline|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
11146979|NCT01855919|BG002|Baseline|Total|Total of all reporting groups
11146980|NCT01855919|FG000|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
11146981|NCT01855919|FG001|Participant Flow|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
10881626|NCT00468286|BG002|Baseline|Total|Total of all reporting groups
10881627|NCT00468286|FG000|Participant Flow|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
10881628|NCT00468286|FG001|Participant Flow|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
11146982|NCT01855919|OG000|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
11146983|NCT01855919|OG001|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
11146984|NCT01855919|OG000|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during the last week.
11146985|NCT01855919|EG000|Reported Event|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
11146986|NCT01855919|EG001|Reported Event|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
11146987|NCT01855945|BG000|Baseline|A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11146988|NCT01855945|BG001|Baseline|A/H3N2C + MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11146989|NCT01855945|BG002|Baseline|A/H3N2C : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11146990|NCT01855945|BG003|Baseline|A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11348859|NCT04142216|BG001|Baseline|Control Group|The patients will not chewing gum during three months.
11348860|NCT04142216|BG002|Baseline|Total|Total of all reporting groups
11348861|NCT04142216|FG000|Participant Flow|Control Group|The patients will not chewing gum during three months.
11348862|NCT04142216|FG001|Participant Flow|Chewing Gum Group|"The patients will be asked to chew on a regular chewing gum for three months.~Chewing Gum: The patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months."
10881629|NCT00468286|OG000|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
10881630|NCT00468286|OG001|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
10881631|NCT00468286|EG000|Reported Event|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
10881632|NCT00468286|EG001|Reported Event|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
10881633|NCT00468299|BG000|Baseline|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
10881634|NCT00468299|BG001|Baseline|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
10881635|NCT00468299|BG002|Baseline|Total|Total of all reporting groups
10881636|NCT00468299|FG000|Participant Flow|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
10881637|NCT00468299|FG001|Participant Flow|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
10881638|NCT00468299|OG000|Outcome|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
10881639|NCT00468299|OG001|Outcome|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
10881640|NCT00468299|OG000|Outcome|Misoprostol and Placebo|Women received a placebo followed by misoprostol 800 mcg buccally
10881641|NCT00468299|OG001|Outcome|Mifepristone and Misoprostol|Women received mifeppristone 200 mg orally followed ny misoprostol 800 mcg buccally
10881642|NCT00468299|EG000|Reported Event|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
10881643|NCT00468299|EG001|Reported Event|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
10881644|NCT00468481|BG000|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
10881645|NCT00468481|BG001|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
10881646|NCT00468481|BG002|Baseline|Total|Total of all reporting groups
10881647|NCT00468481|FG000|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
10881648|NCT00468481|FG001|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
10881649|NCT00468481|OG000|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
10881650|NCT00468481|OG001|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
10881651|NCT00468481|EG000|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
10881652|NCT00468481|EG001|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
10881653|NCT00468546|BG000|Baseline|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
10881654|NCT00468546|BG001|Baseline|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
10881655|NCT00468546|BG002|Baseline|Total|Total of all reporting groups
10881656|NCT00468546|FG000|Participant Flow|Placebo Plus Methotrexate|Eligible participants were administered the placebo by intravenous infusion on Days 1 and 15 along with methotrexate (MTX) 10-25 milligrams (mg) per os (p.o.) or parenterally once a week up to Week 24 and were followed up to Week 104.
10881657|NCT00468546|FG001|Participant Flow|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
10881658|NCT00468546|OG000|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
10881659|NCT00468546|OG001|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
10881660|NCT00468546|EG000|Reported Event|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
11225288|NCT02367014|OG002|Outcome|High Dose|MTP-131 (high dose) 0.25 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10881661|NCT00468546|EG001|Reported Event|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
10881662|NCT00468559|BG000|Baseline|Double Blind Esomeprazole|
10881663|NCT00468559|BG001|Baseline|Double Blind Placebo|
10881664|NCT00468559|BG002|Baseline|Total|Total of all reporting groups
10881665|NCT00468559|FG000|Participant Flow|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
10881666|NCT00468559|FG001|Participant Flow|Double Blind Esomeprazole|
10881667|NCT00468559|FG002|Participant Flow|Double Blind Placebo|
10881668|NCT00468559|OG000|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
10881669|NCT00468559|OG001|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
10881670|NCT00468559|OG000|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
10881671|NCT00468559|EG000|Reported Event|Open-label Phase|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight).
10881672|NCT00468559|EG001|Reported Event|Double Blind Esomeprazole|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
10881673|NCT00468559|EG002|Reported Event|Double Blind Placebo|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
10881674|NCT00468585|BG000|Baseline|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
10881675|NCT00468585|BG001|Baseline|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
10881676|NCT00468585|BG002|Baseline|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
10881677|NCT00468585|BG003|Baseline|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
10881678|NCT00468585|BG004|Baseline|Total|Total of all reporting groups
10881679|NCT00468585|FG000|Participant Flow|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
10881680|NCT00468585|FG001|Participant Flow|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
10881681|NCT00468585|FG002|Participant Flow|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
10881682|NCT00468585|FG003|Participant Flow|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
10881683|NCT00468585|OG000|Outcome|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
10881684|NCT00468585|OG001|Outcome|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
10881685|NCT00468585|OG002|Outcome|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
10881686|NCT00468585|OG003|Outcome|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
10881687|NCT00468585|EG000|Reported Event|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
10881688|NCT00468585|EG001|Reported Event|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
10881689|NCT00468585|EG002|Reported Event|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
10881690|NCT00468585|EG003|Reported Event|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
10881691|NCT00468650|BG000|Baseline|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
10881692|NCT00468650|FG000|Participant Flow|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
10881693|NCT00468650|OG000|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
10881694|NCT00468650|OG000|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
10881695|NCT00468650|EG000|Reported Event|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
10881696|NCT00468676|BG000|Baseline|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
10881697|NCT00468676|BG001|Baseline|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
10881698|NCT00468676|BG002|Baseline|Total|Total of all reporting groups
10881699|NCT00468676|FG000|Participant Flow|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
10881700|NCT00468676|FG001|Participant Flow|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
10881701|NCT00468676|OG000|Outcome|Effect Size of Invervention Group to Standard Care|This was an intent to treat analysis calculating the intervention effect size of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes combined
10881702|NCT00468676|OG000|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
10881703|NCT00468676|OG001|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
10881704|NCT00468676|OG001|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
10881705|NCT00468676|EG000|Reported Event|Usual Care|"Treatment as usual~Treatment as usual: Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care."
10881706|NCT00468676|EG001|Reported Event|Care Management Intervention|"Care management intervention~Nurse-led case management: The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress."
10881707|NCT00468728|BG000|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
10881708|NCT00468728|BG001|Baseline|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
10881709|NCT00468728|BG002|Baseline|Total|Total of all reporting groups
10881710|NCT00468728|FG000|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
10881711|NCT00468728|FG001|Participant Flow|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
11009796|NCT01104246|BG000|Baseline|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
11009797|NCT01104246|FG000|Participant Flow|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
10881712|NCT00468728|OG000|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
10881713|NCT00468728|OG001|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
10881714|NCT00468728|OG000|Outcome|Vancomycin|125 mg administered 4 times daily
10881715|NCT00468728|OG001|Outcome|PAR-101/OPT-80|200 mg administered twice daily
10881716|NCT00468728|EG000|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
10881717|NCT00468728|EG001|Reported Event|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
10881718|NCT00468819|BG000|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881719|NCT00468819|BG001|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881720|NCT00468819|BG002|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881721|NCT00468819|BG003|Baseline|Total|Total of all reporting groups
11009798|NCT01104246|OG000|Outcome|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
11009799|NCT01104246|EG000|Reported Event|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
11009800|NCT01104285|BG000|Baseline|Standard Care|Treatment of pleural effusion with diuresis
11009801|NCT01104285|BG001|Baseline|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
11009802|NCT01104285|BG002|Baseline|Total|Total of all reporting groups
11009803|NCT01104285|FG000|Participant Flow|Standard Care|Treatment of pleural effusion with diuresis
11348863|NCT04142216|OG000|Outcome|Control Group|The patients will not chewing gum during three months.
11009804|NCT01104285|FG001|Participant Flow|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
11009805|NCT01104285|OG000|Outcome|Standard Care|Treatment of pleural effusion with diuresis
11009806|NCT01104285|OG001|Outcome|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
11009807|NCT01104285|EG000|Reported Event|Standard Care|Treatment of pleural effusion with diuresis
11009808|NCT01104285|EG001|Reported Event|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
11009809|NCT01104311|BG000|Baseline|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
11009810|NCT01104311|BG001|Baseline|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
11009811|NCT01104311|BG002|Baseline|Total|Total of all reporting groups
11009812|NCT01104311|FG000|Participant Flow|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
10881722|NCT00468819|FG000|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
11009813|NCT01104311|FG001|Participant Flow|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
11009814|NCT01104311|OG000|Outcome|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
11009815|NCT01104311|OG001|Outcome|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
11009816|NCT01104311|OG000|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
11009817|NCT01104311|OG001|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
11009818|NCT01104311|OG000|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)"
11009819|NCT01104311|OG001|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)"
11146991|NCT01855945|BG004|Baseline|A/H3N2C + MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
10881723|NCT00468819|FG001|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881724|NCT00468819|FG002|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881725|NCT00468819|OG000|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881726|NCT00468819|OG001|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881727|NCT00468819|OG002|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881728|NCT00468819|OG003|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881729|NCT00468819|EG000|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881730|NCT00468819|EG001|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881731|NCT00468819|EG002|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881732|NCT00468819|EG003|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
10881733|NCT00468845|BG000|Baseline|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
11009820|NCT01104311|EG000|Reported Event|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)"
11009821|NCT01104311|EG001|Reported Event|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)"
11009822|NCT01104376|BG000|Baseline|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
11146992|NCT01855945|BG005|Baseline|A/H3N2C : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10881734|NCT00468845|BG001|Baseline|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
10881735|NCT00468845|BG002|Baseline|Placebo|Matching placebo capsule
10881736|NCT00468845|BG003|Baseline|Total|Total of all reporting groups
10881737|NCT00468845|FG000|Participant Flow|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
10881738|NCT00468845|FG001|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
10881739|NCT00468845|FG002|Participant Flow|Placebo|Matching placebo capsule
10881740|NCT00468845|OG000|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
10881741|NCT00468845|OG001|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
10881742|NCT00468845|OG002|Outcome|Placebo|Matching placebo capsule
10881743|NCT00468845|EG000|Reported Event|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
10881744|NCT00468845|EG001|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
10881745|NCT00468845|EG002|Reported Event|Placebo|Matching placebo capsule
10881746|NCT00468858|BG000|Baseline|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881747|NCT00468858|BG001|Baseline|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881748|NCT00468858|BG002|Baseline|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
10881749|NCT00468858|BG003|Baseline|Total|Total of all reporting groups
10881750|NCT00468858|FG000|Participant Flow|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881751|NCT00468858|FG001|Participant Flow|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881752|NCT00468858|FG002|Participant Flow|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
10881753|NCT00468858|OG000|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881754|NCT00468858|OG001|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881755|NCT00468858|OG002|Outcome|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
10881756|NCT00468858|OG000|Outcome|During 31-Day Post Vaccination: F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881757|NCT00468858|OG001|Outcome|During 31-Day Post Vaccination: F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881758|NCT00468858|OG002|Outcome|During 31-Day Post Vaccination: Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
10881759|NCT00468858|OG003|Outcome|After 31-Day Post Vaccination Period: F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881760|NCT00468858|OG004|Outcome|After 31-Day Post Vaccination Period: F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881761|NCT00468858|OG005|Outcome|After 31-Day Post-Vaccination Period: Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
10881762|NCT00468858|OG000|Outcome|F17: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
10881763|NCT00468858|OG001|Outcome|F17 PI (M3)|Post-Transfection F-17 Post-dose 1, month 3
10881764|NCT00468858|OG002|Outcome|F17 PI (M6)|Post-Transfection F-17 Post-dose 1, month 6
10881765|NCT00468858|OG003|Outcome|F17 PII (M7)|Post-Transfection F-17 Post-dose 2, month 7
10881766|NCT00468858|OG004|Outcome|F19: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
10881767|NCT00468858|OG005|Outcome|F19 PI (M3)|Post-Transfection F-19 Post-dose 1, month 3
10881768|NCT00468858|OG006|Outcome|F19 PI (M6)|Post-Transfection F-19 Post-dose 1, month 6
10881769|NCT00468858|OG007|Outcome|F19 PII (M7)|Post-Transfection F-19 Post-dose 2, month 7
10881770|NCT00468858|OG008|Outcome|Placebo: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
10881771|NCT00468858|OG009|Outcome|Placebo: PI (M3)|Placebo control Post-dose 1, month 3
10881772|NCT00468858|OG010|Outcome|Placebo: PI (M6)|Placebo control Post-dose 1, month 6
10881773|NCT00468858|OG011|Outcome|Placebo: PII (M7)|Placebo control Post-dose 2, month 7
10881774|NCT00468858|OG000|Outcome|DEN-1, F17, S-|Antibody DEN-1, Group F17, Pre-vaccination status = S-
10881775|NCT00468858|OG001|Outcome|DEN-1, F17, S+|Antibody DEN-1, Group F17, Pre-vaccination status = S+
10881776|NCT00468858|OG002|Outcome|DEN-1, F17, Total|Antibody DEN-1, Group F17, Pre-vaccination status = Total
10881777|NCT00468858|OG003|Outcome|DEN-1, F19, S-|Antibody DEN-1, Group F19, Pre-vaccination status = S-
10881778|NCT00468858|OG004|Outcome|DEN-1, F19, S+|Antibody DEN-1, Group F19, Pre-vaccination group = S+
10881779|NCT00468858|OG005|Outcome|DEN-1, F19, Total|Antibody DEN-1, Group F19, Pre-vaccination status = Total
10881780|NCT00468858|OG006|Outcome|DEN-1, Placebo, S-|Antibody DEN-1, Placebo group, Pre-vaccination status = S-
10881781|NCT00468858|OG007|Outcome|DEN-1, Placebo, S+|Antibody DEN-1, Placebo group, Pre-vaccination status = S+
11067049|NCT01394978|OG001|Outcome|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.~ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
10881782|NCT00468858|OG008|Outcome|DEN-1, Placebo, Total|Antibody DEN-1, Placebo group, Pre-vaccination status = Total
10881783|NCT00468858|OG009|Outcome|DEN-2, F17, S-|Antibody DEN-2, Group F17, Pre-vaccination status = S-
10881784|NCT00468858|OG010|Outcome|DEN-2, F17, S+|Antibody DEN-2, Group F17, Pre-vaccination status = S+
10881785|NCT00468858|OG011|Outcome|DEN-2, F17, Total|Antibody DEN-2,. Group F17, Pre-vaccination status = Total
10881786|NCT00468858|OG012|Outcome|DEN-2, F19, S-|Antibody DEN-2, Group F19, Pre-vaccination status = S-
10881787|NCT00468858|OG013|Outcome|DEN-2, F19, S+|Antibody DEN-2, Group F19, Pre-vaccination status = S+
10881788|NCT00468858|OG014|Outcome|DEN-2, F19, Total|Antibody DEN-2, Group F19, Pre-vaccination status = Total
10881789|NCT00468858|OG015|Outcome|DEN-2, Placebo, S-|Antibody DEN-2, Placebo group, Pre-vaccination status = S-
10881790|NCT00468858|OG016|Outcome|DEN-2, Placebo, S+|Antibody DEN-2, Placebo group, Pre-vaccination status = S+
10881791|NCT00468858|OG017|Outcome|DEN-2, Placebo, Total|Antibody DEN-2, Placebo group, Pre-vaccination status = Total
10881792|NCT00468858|OG018|Outcome|DEN-3, F17, S-|Antibody DEN-3, Group F17, Pre-vaccination status = S-
10881793|NCT00468858|OG019|Outcome|DEN-3, F17, S+|Antibody DEN-3, Group F17, Pre-vaccination status = S+
10881794|NCT00468858|OG020|Outcome|DEN-3, F17, Total|Antibody DEN-3, Group F17, Pre-vaccination status = Total
10881795|NCT00468858|OG021|Outcome|DEN-3, F19, S-|Antibody DEN-3, Group F19, Pre-vaccination status = S-
10881796|NCT00468858|OG022|Outcome|DEN-3, F19, S+|Antibody DEN-3, Group F19, Pre-vaccination status = S+
10881797|NCT00468858|OG023|Outcome|DEN-3, F19, Total|Antibody DEN-3, Group F19, Pre-vaccination status = Total
10881798|NCT00468858|OG024|Outcome|DEN-3, Placebo, S-|Antibody DEN-3, Placebo group, Pre-vaccination status = S-
10881799|NCT00468858|OG025|Outcome|DEN-3, Placebo, S+|Antibody DEN-3, Placebo group, Pre-vaccination status = S+
10881800|NCT00468858|OG026|Outcome|DEN-3, Placebo, Total|Antibody DEN-3, Placebo group, Pre-vaccination status = Total
10881801|NCT00468858|OG027|Outcome|DEN-4, F17, S-|Antibody DEN-4, Group F17, Pre-vaccination status = S-
10881802|NCT00468858|OG028|Outcome|DEN-4, F17, S+|Antibody DEN-4, Group F17, Pre-vaccination status = S+
10881803|NCT00468858|OG029|Outcome|DEN-4, F17, Total|Antibody DEN-4, Group F17, Pre-vaccination status = Total
10881804|NCT00468858|OG030|Outcome|DEN-4, F19, S-|Antibody DEN-4, Group F19, Pre-vaccination status = S-
10881805|NCT00468858|OG031|Outcome|DEN-4, F19, S+|Antibody DEN-4, Group F19, Pre-vaccination status = S+
10881806|NCT00468858|OG032|Outcome|DEN-4, F19, Total|Antibody DEN-4, Group F19, Pre-vaccination status = Total
10881807|NCT00468858|OG033|Outcome|DEN-4, Placebo, S-|Antibody DEN-4, Placebo group, Pre-vaccination status = S-
10881808|NCT00468858|OG034|Outcome|DEN-4, Placebo, S+|Antibody DEN-4, Placebo group, Pre-vaccination status = S+
10881809|NCT00468858|OG035|Outcome|DEN-4, Placebo, Total|Antibody DEN-4, Placebo group, Pre-vaccination status = Total
10881810|NCT00468858|EG000|Reported Event|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881811|NCT00468858|EG001|Reported Event|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
10881812|NCT00468858|EG002|Reported Event|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
10881813|NCT00468910|BG000|Baseline|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
10881814|NCT00468910|BG001|Baseline|Placebo|Patients receive oral placebo once daily.
10881815|NCT00468910|BG002|Baseline|Total|Total of all reporting groups
10881816|NCT00468910|FG000|Participant Flow|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
10881817|NCT00468910|FG001|Participant Flow|Placebo|Patients receive oral placebo once daily.
10881818|NCT00468910|OG000|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) 325 mg once daily.
11146993|NCT01855945|BG006|Baseline|A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11146994|NCT01855945|BG007|Baseline|A/H3N2C + MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11146995|NCT01855945|BG008|Baseline|A/H3N2C : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11146996|NCT01855945|BG009|Baseline|A/H3N2C + 1/2 MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11146997|NCT01855945|BG010|Baseline|A/H3N2C + MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11146998|NCT01855945|BG011|Baseline|A/H3N2C : ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11146999|NCT01855945|BG012|Baseline|Total|Total of all reporting groups
11147000|NCT01855945|FG000|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11147001|NCT01855945|FG001|Participant Flow|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
10881819|NCT00468910|OG001|Outcome|Placebo|Patients receive oral placebo once daily.
10881820|NCT00468910|OG000|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
10881821|NCT00468910|EG000|Reported Event|Acetylsalicylic Acid|"Patients receive oral acetylsalicylic acid (aspirin) once daily.~acetylsalicylic acid: Given orally~laboratory biomarker analysis: Correlative study"
10881822|NCT00468910|EG001|Reported Event|Placebo|"Patients receive oral placebo once daily.~placebo: Given orally~laboratory biomarker analysis: Correlative study"
10881823|NCT00469014|BG000|Baseline|Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m^2 intravenous (IV) Daily + Fludarabine 30 mg/m^2 IV Daily; + Clofarabine 10 mg/m^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881824|NCT00469014|BG001|Baseline|Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m^2 IV + Fludarabine 20 mg/m^2 IV Daily + Clofarabine 20 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881825|NCT00469014|BG002|Baseline|Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m^2 IV Daily + Fludarabine 10 mg/m^2 IV Daily + Clofarabine 30 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881826|NCT00469014|BG003|Baseline|Arm 4: Busulfan + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m^2 IV Daily + Clofarabine 40 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881827|NCT00469014|BG004|Baseline|Total|Total of all reporting groups
10881828|NCT00469014|FG000|Participant Flow|Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m^2 intravenous (IV) Daily + Fludarabine 30 mg/m^2 IV Daily; + Clofarabine 10 mg/m^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881829|NCT00469014|FG001|Participant Flow|Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m^2 IV + Fludarabine 20 mg/m^2 IV Daily + Clofarabine 20 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
11147002|NCT01855945|FG002|Participant Flow|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147003|NCT01855945|FG003|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147004|NCT01855945|FG004|Participant Flow|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147005|NCT01855945|FG005|Participant Flow|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147006|NCT01855945|FG006|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147007|NCT01855945|FG007|Participant Flow|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147008|NCT01855945|FG008|Participant Flow|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11225289|NCT02367014|OG003|Outcome|Placebo|Placebo Comparator (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days
10881830|NCT00469014|FG002|Participant Flow|Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m^2 IV Daily + Fludarabine 10 mg/m^2 IV Daily + Clofarabine 30 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881831|NCT00469014|FG003|Participant Flow|Arm 4: Busulfan + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m^2 IV Daily + Clofarabine 40 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881832|NCT00469014|OG000|Outcome|Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m^2 intravenous (IV) Daily + Fludarabine 30 mg/m^2 IV Daily; + Clofarabine 10 mg/m^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881833|NCT00469014|OG001|Outcome|Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m^2 IV + Fludarabine 20 mg/m^2 IV Daily + Clofarabine 20 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881834|NCT00469014|OG002|Outcome|Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m^2 IV Daily + Fludarabine 10 mg/m^2 IV Daily + Clofarabine 30 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881835|NCT00469014|OG003|Outcome|Arm 4: Busulfan + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m^2 IV Daily + Clofarabine 40 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881836|NCT00469014|EG000|Reported Event|Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m^2 intravenous (IV) Daily + Fludarabine 30 mg/m^2 IV Daily; + Clofarabine 10 mg/m^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881837|NCT00469014|EG001|Reported Event|Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m^2 IV + Fludarabine 20 mg/m^2 IV Daily + Clofarabine 20 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881838|NCT00469014|EG002|Reported Event|Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m^2 IV Daily + Fludarabine 10 mg/m^2 IV Daily + Clofarabine 30 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881839|NCT00469014|EG003|Reported Event|Arm 4: Busulfan + Clofarabine|4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m^2 IV Daily + Clofarabine 40 mg/m^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
10881840|NCT00469079|BG000|Baseline|Assigned to NRT|Nicotine gum or nicotine lozenge
10881841|NCT00469079|BG001|Baseline|Assigned to Taboka|Taboka - oral tobacco product
10881842|NCT00469079|BG002|Baseline|Assigned to Camel Snus|Camel Snus - oral tobacco product
10881843|NCT00469079|BG003|Baseline|Total|Total of all reporting groups
10881844|NCT00469079|FG000|Participant Flow|Assigned to NRT|Nicotine gum or nicotine lozenge
10881845|NCT00469079|FG001|Participant Flow|Assigned to Taboka|Taboka - oral tobacco product
10881846|NCT00469079|FG002|Participant Flow|Assigned to Camel Snus|Camel Snus - oral tobacco product
10881847|NCT00469079|OG000|Outcome|Medicinal Nicotine|4 mg nicotine gum or nicotine lozenge
10881848|NCT00469079|OG001|Outcome|Taboka|Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
10881849|NCT00469079|OG002|Outcome|Snus|Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
10881850|NCT00469079|OG000|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
10881851|NCT00469079|OG001|Outcome|Taboka|A spitless, oral tobacco pouch.
10881852|NCT00469079|OG002|Outcome|Snus|A spitless, oral tobacco pouch.
10881853|NCT00469079|OG000|Outcome|Medicinal Nicotine|Nicotine gum or nicotine lozenge
10881854|NCT00469079|OG001|Outcome|Taboka|Taboka - oral tobacco product
10881855|NCT00469079|OG002|Outcome|Camel Snus|Camel Snus - oral tobacco product
10881856|NCT00469079|EG000|Reported Event|Assigned to NRT|Nicotine gum or nicotine lozenge
10881857|NCT00469079|EG001|Reported Event|Assigned to Taboka|Taboka - oral tobacco product
10881858|NCT00469079|EG002|Reported Event|Assigned to Camel Snus|Camel Snus - oral tobacco product
10881859|NCT00469092|BG000|Baseline|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
10881860|NCT00469092|BG001|Baseline|Glargine|Insulin glargine + metformin + glimepiride
10881861|NCT00469092|BG002|Baseline|Total|Total of all reporting groups
10881862|NCT00469092|FG000|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
10881863|NCT00469092|FG001|Participant Flow|Glargine|Insulin glargine + metformin + glimepiride
10881864|NCT00469092|OG000|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
10881865|NCT00469092|OG001|Outcome|Glargine|Insulin glargine + metformin + glimepiride
10881866|NCT00469092|EG000|Reported Event|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
10881867|NCT00469092|EG001|Reported Event|Glargine|Insulin glargine + metformin + glimepiride
10881868|NCT00469144|BG000|Baseline|Fixed-Dose Busulfan + Fludarabine|Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.
10881869|NCT00469144|BG001|Baseline|Adjusted Dose Busulfan + Fludarabine|"Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.~Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%."
10881870|NCT00469144|BG002|Baseline|Total|Total of all reporting groups
10881871|NCT00469144|FG000|Participant Flow|Fixed-Dose Busulfan + Fludarabine|Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.
10881872|NCT00469144|FG001|Participant Flow|Adjusted Dose Busulfan + Fludarabine|"Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.~Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%."
10881873|NCT00469144|OG000|Outcome|Fixed-Dose: Participants in CR|Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.
10881874|NCT00469144|OG001|Outcome|Adjusted Dose: Participants in CR|"Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.~Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%."
10881875|NCT00469144|OG002|Outcome|Fixed Dose: Participants Not in CR|Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.
10881876|NCT00469144|OG003|Outcome|Adjusted Dose: Participants Not in CR|"Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.~Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%."
10881877|NCT00469144|OG000|Outcome|Fixed-Dose Busulfan + Fludarabine|Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.
10881878|NCT00469144|OG001|Outcome|Adjusted Dose Busulfan + Fludarabine|"Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.~Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%."
10881879|NCT00469144|EG000|Reported Event|Fixed-Dose Busulfan + Fludarabine|Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.
10881880|NCT00469144|EG001|Reported Event|Adjusted Dose Busulfan + Fludarabine|"Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.~Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%."
10881881|NCT00469209|BG000|Baseline|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881882|NCT00469209|BG001|Baseline|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881883|NCT00469209|BG002|Baseline|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881884|NCT00469209|BG003|Baseline|Total|Total of all reporting groups
11348864|NCT04142216|OG001|Outcome|Chewing Gum Group|"The patients will be asked to chew on a regular chewing gum for three months.~Chewing Gum: The patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months."
11348865|NCT04142216|EG000|Reported Event|Control Group|The patients will not chewing gum during three months.
10881885|NCT00469209|FG000|Participant Flow|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881886|NCT00469209|FG001|Participant Flow|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
11067050|NCT01394978|EG000|Reported Event|Control|"No treatment.~Control: Standard surgical techniques including staples and sutures."
11147009|NCT01855945|FG009|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11348866|NCT04142216|EG001|Reported Event|Chewing Gum Group|"The patients will be asked to chew on a regular chewing gum for three months.~Chewing Gum: The patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months."
10881887|NCT00469209|FG002|Participant Flow|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881888|NCT00469209|OG000|Outcome|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881889|NCT00469209|OG001|Outcome|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881890|NCT00469209|OG002|Outcome|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881891|NCT00469209|EG000|Reported Event|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881892|NCT00469209|EG001|Reported Event|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881893|NCT00469209|EG002|Reported Event|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
10881894|NCT00469274|BG000|Baseline|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
10881895|NCT00469274|BG001|Baseline|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
10881896|NCT00469274|BG002|Baseline|Total|Total of all reporting groups
10881897|NCT00469274|FG000|Participant Flow|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
10881898|NCT00469274|FG001|Participant Flow|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
10881899|NCT00469274|OG000|Outcome|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
10881900|NCT00469274|OG001|Outcome|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
10881901|NCT00469274|EG000|Reported Event|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
10881902|NCT00469274|EG001|Reported Event|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
10881903|NCT00469391|BG000|Baseline|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss~GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
10881904|NCT00469391|BG001|Baseline|Sham Control|Sham Procedure: Weight loss
10881905|NCT00469391|BG002|Baseline|Total|Total of all reporting groups
10881906|NCT00469391|FG000|Participant Flow|GI Sleeve|GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss followed by standard-of-care diet therapy
10881907|NCT00469391|FG001|Participant Flow|Sham Control|Sham Procedure followed by standard-of-care diet therapy
10881908|NCT00469391|OG000|Outcome|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss~GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
10881909|NCT00469391|OG001|Outcome|Sham Control|Sham Procedure: Weight loss
10881910|NCT00469391|EG000|Reported Event|GI Sleeve|N=26 for attempted device implant procedures. There were 2 subjects who withdrew from the study before the procedure and 4 unsuccessful procedure. Thus, N=21 for ITT population ( subjects with implanted devices).
10881911|NCT00469391|EG001|Reported Event|Sham Control|3 subjects withdrew before the procedure. N=26 for the ITT population.
10881912|NCT00469456|BG000|Baseline|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
10881913|NCT00469456|BG001|Baseline|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
10881914|NCT00469456|BG002|Baseline|Total|Total of all reporting groups
10881915|NCT00469456|FG000|Participant Flow|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
10881916|NCT00469456|FG001|Participant Flow|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
10881917|NCT00469456|OG000|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
10881918|NCT00469456|OG001|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
10881919|NCT00469456|EG000|Reported Event|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
10881920|NCT00469456|EG001|Reported Event|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
10881921|NCT00469508|BG000|Baseline|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
10881922|NCT00469508|BG001|Baseline|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
10881923|NCT00469508|BG002|Baseline|Total|Total of all reporting groups
10881924|NCT00469508|FG000|Participant Flow|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
10881925|NCT00469508|FG001|Participant Flow|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
11225290|NCT02367014|OG001|Outcome|Intermediate|MTP-131 (intermediate dose) 0.10 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10881926|NCT00469508|OG000|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
10881927|NCT00469508|OG001|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
10881928|NCT00469508|EG000|Reported Event|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
10881929|NCT00469508|EG001|Reported Event|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
10881930|NCT00469833|BG000|Baseline|Arm 1|"Within subjects comparison; before and after treatment.~Beta-cell function measured with OGTT/hyperglycemic clamp"
10881931|NCT00469833|FG000|Participant Flow|Uncontrolled Type 2 Diabetic Subjects|Eligible subjects will have measures of insulin secretion measured using the OGTT/hyperglycemic clamp technique before and after 2 months of treatment to lower blood glucose.
10881932|NCT00469833|OG000|Outcome|Oral Glucose|Oral glucose administered to uncontrolled type 2 diabetic subjects.
10881933|NCT00469833|OG001|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects.
10881934|NCT00469833|OG000|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects
10881935|NCT00469833|OG001|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects
10881936|NCT00469833|OG000|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects.
10881937|NCT00469833|OG001|Outcome|IV Glucose|IV glucose administered to uncontrolled Type 2 diabetic subjects.
10881938|NCT00469833|OG000|Outcome|Uncontrolled Type 2 Diabetic Subjects|
10881939|NCT00469833|EG000|Reported Event|Arm 1|"Within subjects comparison; before and after treatment.~Beta-cell function measured with OGTT/hyperglycemic clamp"
10881940|NCT00469859|BG000|Baseline|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
10881941|NCT00469859|BG001|Baseline|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
10881942|NCT00469859|BG002|Baseline|Total|Total of all reporting groups
10881943|NCT00469859|FG000|Participant Flow|Group 1 (Lestaurtinib Dose 50 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
10881944|NCT00469859|FG001|Participant Flow|Group 2 (Lestaurtinib: Dose 62.5 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)~cytarabine"
10881945|NCT00469859|OG000|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
11009823|NCT01104376|FG000|Participant Flow|CYP2B6 Activity|"CYP2B6 activity was measured using efavirenz metabolism and pharmacokinetics at baseline and after pretreatment with voriconazole.~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.~In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
11009824|NCT01104376|OG000|Outcome|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
11009825|NCT01104376|EG000|Reported Event|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
11009826|NCT01104402|BG000|Baseline|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
11009827|NCT01104402|BG001|Baseline|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
11009828|NCT01104402|BG002|Baseline|Total|Total of all reporting groups
11009829|NCT01104402|FG000|Participant Flow|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
11009830|NCT01104402|FG001|Participant Flow|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
11009831|NCT01104402|OG000|Outcome|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
11147010|NCT01855945|FG010|Participant Flow|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147011|NCT01855945|FG011|Participant Flow|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10881946|NCT00469859|OG001|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
10881947|NCT00469859|EG000|Reported Event|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
10881948|NCT00469859|EG001|Reported Event|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
10881949|NCT00469898|BG000|Baseline|Therapeutic Intervention|
10881950|NCT00469898|FG000|Participant Flow|Therapeutic Intervention|
10881951|NCT00469898|OG000|Outcome|Therapeutic Intervention|
10881952|NCT00469898|EG000|Reported Event|Therapeutic Intervention|
10881953|NCT00469911|BG000|Baseline|Heart Transplant|"Compare Magnetic resonance myocardial lipid measurements with biopsy derived ex vivo measurements~Magnetic Resonance Spectroscopy: It is a noninvasive procedure that provides detailed body images on any plane.~Endocardial Biopsy: This is a standard of care procedure that is already performed on heart transplant patients. This is a procedure that takes a biopsy (tissue sample) of the heart muscle."
10881954|NCT00469911|BG001|Baseline|Control Subjects|Control subjects with a broad range of body mass indexes and physiological conditions.
10881955|NCT00469911|BG002|Baseline|Total|Total of all reporting groups
10881956|NCT00469911|FG000|Participant Flow|Heart Transplant|"Compare Magnetic resonance myocardial lipid measurements with biopsy derived ex vivo measurements~Magnetic Resonance Spectroscopy: It is basically the same as an MRI. It is a noninvasive procedure that provides detailed body images on any plane.~Endocardial Biopsy: This is a standard of care procedure that is already performed on heart transplant patients. This is a procedure that takes a biopsy (tissue sample) of the heart muscle."
11147012|NCT01855945|OG000|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
10881957|NCT00469911|FG001|Participant Flow|Controls|Normal volunteers used to assess reproducability of the MRS measurements
10881958|NCT00469911|OG000|Outcome|Heart Transplant Patients|Measurement of triglycerides in heart transplant patients using MRI
10881959|NCT00469911|EG000|Reported Event|Heart Transplant - Endomyocardial Biopsy|This is a procedure that takes a biopsy (tissue sample) of the heart muscle., and it was compared to the MRS Spectroscopy images
10881960|NCT00469911|EG001|Reported Event|Control Subjects|Normal volunteers used to assess reproducability of the MRS measurements
10881961|NCT00470054|BG000|Baseline|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
10881962|NCT00470054|FG000|Participant Flow|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
10881963|NCT00470054|OG000|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
10881964|NCT00470054|EG000|Reported Event|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
10881965|NCT00470093|BG000|Baseline|Interleukin-6 and Interferon-α|"Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.~recombinant interferon-α~recombinant interleukin-6"
10881966|NCT00470093|FG000|Participant Flow|Interleukin-6 and Interferon-α|"Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.~recombinant interferon-α~recombinant interleukin-6"
10881967|NCT00470093|OG000|Outcome|Interleukin-6 and Interferon-α|"Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.~recombinant interferon-α~recombinant interleukin-6"
10881968|NCT00470093|EG000|Reported Event|Interleukin-6 and Interferon-α|"Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.~recombinant interferon-α~recombinant interleukin-6"
10881969|NCT00470106|BG000|Baseline|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
10881970|NCT00470106|BG001|Baseline|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
10881971|NCT00470106|BG002|Baseline|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
10881972|NCT00470106|BG003|Baseline|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
10881973|NCT00470106|BG004|Baseline|Total|Total of all reporting groups
10881974|NCT00470106|FG000|Participant Flow|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
10881975|NCT00470106|FG001|Participant Flow|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
10881976|NCT00470106|FG002|Participant Flow|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
10881977|NCT00470106|FG003|Participant Flow|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
10881978|NCT00470106|OG000|Outcome|Social Cognitive Skills Training|"social cognitive skills training~Social Cognitive skills training: Group training on emotion perception, social perception, and understanding others' mental states."
10881979|NCT00470106|OG001|Outcome|Cognitive Remediation|"cognitive remediation~Cognitive remediation: Computer exercises in attention, memory, and speed of processing."
10881980|NCT00470106|OG002|Outcome|Hybrid Intervention|"combined social cognitive and cognitive remediation training~hybrid intervention: A combination of the two groups listed above."
10881981|NCT00470106|OG003|Outcome|Skills Training|"control training~skills training: Skills training in how to identify symptoms of illness and medication side effects."
10881982|NCT00470106|OG000|Outcome|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
10881983|NCT00470106|OG001|Outcome|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
10881984|NCT00470106|OG002|Outcome|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
10881985|NCT00470106|OG003|Outcome|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
10881986|NCT00470106|EG000|Reported Event|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
10881987|NCT00470106|EG001|Reported Event|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
10881988|NCT00470106|EG002|Reported Event|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
10881989|NCT00470106|EG003|Reported Event|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
10881990|NCT00470158|BG000|Baseline|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
10881991|NCT00470158|BG001|Baseline|Separate Iron and Zinc|iron, alternating daily with zinc
10881992|NCT00470158|BG002|Baseline|Iron Alone|iron, alternating daily with placebo
10881993|NCT00470158|BG003|Baseline|Zinc Alone|zinc, alternating daily with placebo
10881994|NCT00470158|BG004|Baseline|Placebo|placebo daily
10881995|NCT00470158|BG005|Baseline|Total|Total of all reporting groups
10881996|NCT00470158|FG000|Participant Flow|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
10881997|NCT00470158|FG001|Participant Flow|Separate Iron and Zinc|iron, alternating daily with zinc
10881998|NCT00470158|FG002|Participant Flow|Iron Alone|iron, alternating daily with placebo
10881999|NCT00470158|FG003|Participant Flow|Zinc Alone|zinc, alternating daily with placebo
10882000|NCT00470158|FG004|Participant Flow|Placebo|placebo daily
10882001|NCT00470158|OG000|Outcome|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
10882002|NCT00470158|OG001|Outcome|Separate Iron and Zinc|iron, alternating daily with zinc
10882003|NCT00470158|OG002|Outcome|Iron Alone|iron, alternating daily with placebo
10882004|NCT00470158|OG003|Outcome|Zinc Alone|zinc, alternating daily with placebo
10882005|NCT00470158|OG004|Outcome|Placebo|placebo daily
10882006|NCT00470158|EG000|Reported Event|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
10882007|NCT00470158|EG001|Reported Event|Separate Iron and Zinc|iron, alternating daily with zinc
10882008|NCT00470158|EG002|Reported Event|Iron Alone|iron, alternating daily with placebo
10882009|NCT00470158|EG003|Reported Event|Zinc Alone|zinc, alternating daily with placebo
10882010|NCT00470158|EG004|Reported Event|Placebo|placebo daily
10882011|NCT00470184|BG000|Baseline|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
10882012|NCT00470184|FG000|Participant Flow|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
10882013|NCT00470184|OG000|Outcome|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
10882014|NCT00470184|OG000|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
10882015|NCT00470184|EG000|Reported Event|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
10882016|NCT00470262|BG000|Baseline|Fenofibrate 145 mg PO QD|Treatment fenofibrate 145 mg PO QD in subjects with pre diabetes
10882017|NCT00470262|BG001|Baseline|Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD|Treatment with Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD in subjects with pre diabetes
10882018|NCT00470262|BG002|Baseline|Total|Total of all reporting groups
11348867|NCT04141930|BG000|Baseline|Study Drug Eligible|"Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant~Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset"
11348868|NCT04141930|FG000|Participant Flow|Study Drug Eligible|"Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant. Individuals need to be eligible based on on-label use according to their age and medical history.~Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset"
10882019|NCT00470262|FG000|Participant Flow|Fenofibrate|Treatment with fenofibrate 145mg PO QD
10882020|NCT00470262|FG001|Participant Flow|Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD|Pioglitazone and Fenofibrate: Subjects will be randomized to a combination of both fenofibrate(145mg PO QD) and pioglitazone 45 mg PO QD
11009832|NCT01104402|OG001|Outcome|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
10882021|NCT00470262|OG000|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
10882022|NCT00470262|OG001|Outcome|Fenofibrate 145 mg PO QD + Pioglitazone|Treatment with fenofibrate and pioglitazone in subjects with pre diabetes
10882023|NCT00470262|OG001|Outcome|Fenofibrate 145mg PO QD + Pioglitazone 45mg PO BID|Treatment with pioglitazone and fenofibrate in subjects with pre diabetes
10882024|NCT00470262|EG000|Reported Event|Fenofibrate 145mg PO QD|Treatment with fenofibrate 145 mg PO QD in subjects with pre diabetes
10882025|NCT00470262|EG001|Reported Event|Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD|Treatment with fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD in subjects with pre diabetes
10882026|NCT00470275|BG000|Baseline|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
10882027|NCT00470275|FG000|Participant Flow|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
10882028|NCT00470275|OG000|Outcome|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
10882029|NCT00470275|EG000|Reported Event|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
11009833|NCT01104402|EG000|Reported Event|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
11147013|NCT01855945|OG001|Outcome|A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
11147014|NCT01855945|OG002|Outcome|A/H3N2C - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147015|NCT01855945|OG000|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59 Subjects 3 to <9 years.
11147016|NCT01855945|OG001|Outcome|A/H3N2C + MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147017|NCT01855945|OG002|Outcome|A/H3N2C - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147018|NCT01855945|OG000|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147019|NCT01855945|OG001|Outcome|A/H3N2C + MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147020|NCT01855945|OG002|Outcome|A/H3N2C - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147021|NCT01855945|OG000|Outcome|A/H3N2C + 1/2 MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11225291|NCT02367014|OG002|Outcome|High|MTP-131 (high dose) 0.25 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10882030|NCT00470301|BG000|Baseline|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
10882031|NCT00470301|FG000|Participant Flow|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
10882032|NCT00470301|OG000|Outcome|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
10882033|NCT00470301|OG000|Outcome|Arm I|"Tipifarnib plus sequential weekly paclitaxel followed by doxorubicin plus cyclophosphamide~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin: Given IV~cyclophosphamide: Given IV"
10882034|NCT00470301|EG000|Reported Event|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
10882035|NCT00470366|BG000|Baseline|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
10882036|NCT00470366|FG000|Participant Flow|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
11348869|NCT04141930|FG001|Participant Flow|Study Drug Ineligible|Individuals not eligible to receive on-label use of Baloxavir due to age or medical history
10882037|NCT00470366|OG000|Outcome|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
10882038|NCT00470366|EG000|Reported Event|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
10882039|NCT00470392|BG000|Baseline|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
10882040|NCT00470392|BG001|Baseline|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
10882041|NCT00470392|BG002|Baseline|Total|Total of all reporting groups
10882042|NCT00470392|FG000|Participant Flow|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
10882043|NCT00470392|FG001|Participant Flow|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
10882044|NCT00470392|OG000|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
11009834|NCT01104402|EG001|Reported Event|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
11009835|NCT01104415|BG000|Baseline|Telotristat Etiprate- Core Phase|Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period.
11348870|NCT04141930|OG000|Outcome|Study Drug Eligible|"Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant~Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset"
11225292|NCT02367014|EG000|Reported Event|Low Dose|MTP-131 (low dose) 0.01 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10882045|NCT00470392|OG001|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
10882046|NCT00470392|OG001|Outcome|Clobetasol|"Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.~No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated."
10882047|NCT00470392|EG000|Reported Event|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
10882048|NCT00470392|EG001|Reported Event|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
10882049|NCT00470418|BG000|Baseline|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
10882050|NCT00470418|BG001|Baseline|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
10882051|NCT00470418|BG002|Baseline|Total|Total of all reporting groups
10882052|NCT00470418|FG000|Participant Flow|NIC5-15|"NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects. Subjects received escalating doses of 1500, 3000 and 5000 mg daily over the course of the study.~Subjects with Alzheimer's Disease"
10882053|NCT00470418|FG001|Participant Flow|Placebo|"Placebo: placebo comparator identical in pill size, appearance and number~Subjects with Alzheimer's Disease"
10882054|NCT00470418|OG000|Outcome|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
10882055|NCT00470418|OG001|Outcome|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
10882056|NCT00470418|EG000|Reported Event|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
11009836|NCT01104415|FG000|Participant Flow|Telotristat Etiprate- Core Phase|Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period.
11009837|NCT01104415|FG001|Participant Flow|Telotristat Etiprate -Extension Period|Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.
10882057|NCT00470418|EG001|Reported Event|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
10882058|NCT00470470|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
10882059|NCT00470470|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
10882060|NCT00470470|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
10882061|NCT00470470|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
10882062|NCT00470535|BG000|Baseline|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
10882063|NCT00470535|FG000|Participant Flow|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
10882064|NCT00470535|OG000|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
10882065|NCT00470535|EG000|Reported Event|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
10887155|NCT00499096|EG000|Reported Event|Arm 1|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
10882066|NCT00470548|BG000|Baseline|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
11225293|NCT02367014|EG001|Reported Event|Intermediate Dose|MTP-131 (intermediate dose) 0.10 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
10882067|NCT00470548|BG001|Baseline|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
10882068|NCT00470548|BG002|Baseline|Total|Total of all reporting groups
10882069|NCT00470548|FG000|Participant Flow|Phase I: Dose Level 1|Pemetrexed 500 mg/m2 plus Abraxane 180 mg/m2
10882070|NCT00470548|FG001|Participant Flow|Phase I: Dose Level 2|Pemetrexed 500 mg/m2 plus Abraxane 220 mg/m2
10882071|NCT00470548|FG002|Participant Flow|Phase I: Dose Level 3|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
10882072|NCT00470548|FG003|Participant Flow|Phase II|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
10882073|NCT00470548|OG000|Outcome|Phase I: Dose Level 1|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
10882074|NCT00470548|OG001|Outcome|Phase I: Dose Level 2|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 220 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
10882075|NCT00470548|OG002|Outcome|Phase I: Dose Level 3|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
10882076|NCT00470548|OG000|Outcome|Phase II: Pemetrexed and Abraxane|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
10882077|NCT00470548|OG000|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
10882078|NCT00470548|OG001|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
11147022|NCT01855945|OG001|Outcome|A/H3N2C + MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
11147023|NCT01855945|OG002|Outcome|A/H3N2C - Age Group: ≥65 YEARS|Subjects ≥65 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 15 µg H3N2c antigen.
11147024|NCT01855945|OG000|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
10882079|NCT00470548|EG000|Reported Event|Phase I: Abraxane and Alimta|"Three dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days.~Abraxane: ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)~Alimta: Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)"
10882080|NCT00470548|EG001|Reported Event|Phase II: Abraxane and Alimta|"Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days.~Abraxane: ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)~Alimta: Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)"
10882081|NCT00470600|BG000|Baseline|Placebo|250 mL of normal saline.
10882082|NCT00470600|BG001|Baseline|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
10882083|NCT00470600|BG002|Baseline|Total|Total of all reporting groups
10882084|NCT00470600|FG000|Participant Flow|Placebo|250 mL of normal saline.
10882085|NCT00470600|FG001|Participant Flow|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
10882086|NCT00470600|OG000|Outcome|Placebo|250 mL of normal saline.
10882087|NCT00470600|OG001|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
10882088|NCT00470600|EG000|Reported Event|Placebo|250 mL of normal saline.
10882089|NCT00470600|EG001|Reported Event|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
10882090|NCT00470626|BG000|Baseline|Celect Vena Cava Filter|
10882091|NCT00470626|FG000|Participant Flow|Celect Vena Cava Filter|
10882092|NCT00470626|OG000|Outcome|Celect Vena Cava Filter|
10882093|NCT00470626|EG000|Reported Event|Celect Vena Cava Filter|
10882094|NCT00470717|BG000|Baseline|Phone Calling|
10882095|NCT00470717|FG000|Participant Flow|Phone Calling|"Weekly telephone call. There are not two arms to the study. The primary intervention was phone calling weekly to assess ability to complete phone call and obtain feeding data.~Weekly telephone call: Details of feeding and health/sickness were obtained"
10882096|NCT00470717|OG000|Outcome|Phone Calling|"Weekly telephone call. There are not two arms to the study. The primary intervention was phone calling weekly to assess ability to complete phone call and obtain feeding data.~Weekly telephone call: Details of feeding and health/sickness were obtained"
10882097|NCT00470717|EG000|Reported Event|Phone Calling|"Weekly telephone call. There are not two arms to the study. The primary intervention is phone calling weekly to assess ability to complete phone call and obtain feeding data.~Weekly telephone call: Details of feeding and health/sickness will be obtained"
10882098|NCT00470834|BG000|Baseline|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
11147025|NCT01855945|OG001|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11225294|NCT02367014|EG002|Reported Event|High Dose|MTP-131 (high dose) 0.25 mg/kg/hour administered as single day intravenous infusion over 2 hours for 5 days
11147026|NCT01855945|OG002|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147027|NCT01855945|OG003|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147028|NCT01855945|OG004|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147029|NCT01855945|OG005|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147030|NCT01855945|OG006|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147031|NCT01855945|OG007|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147032|NCT01855945|OG008|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147033|NCT01855945|OG009|Outcome|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147034|NCT01855945|OG010|Outcome|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147035|NCT01855945|OG011|Outcome|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11225295|NCT02367014|EG003|Reported Event|Placebo|Placebo: Placebo Comparator (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days
10882099|NCT00470834|BG001|Baseline|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
10882100|NCT00470834|BG002|Baseline|Total|Total of all reporting groups
10882101|NCT00470834|FG000|Participant Flow|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
10882102|NCT00470834|FG001|Participant Flow|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
10882103|NCT00470834|OG000|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
10882104|NCT00470834|OG001|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
10882105|NCT00470834|EG000|Reported Event|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
10882106|NCT00470834|EG001|Reported Event|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
10882107|NCT00470847|BG000|Baseline|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
10882108|NCT00470847|FG000|Participant Flow|Lapatinib,Whole Brain Radiation,Herceptin|Participants received lapatinib, orally, 750mg twice on day one followed by 1000mg, 1250mg, or 1500mg once daily. Whole Brain Radiation therapy (WBRT) (37.5 Gy, 15 fractions) began 1-8 days after starting lapatinib. Lapatinib was continued through WBRT. Following WBRT, patients received trastuzumab intravenously 2mg/kg weekly and lapatinib 1000mg orally once daily.
10882109|NCT00470847|OG000|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
10882110|NCT00470847|EG000|Reported Event|Dose Level 2|n=27 participants Maximum Tolerated Dose 1250 mg lapatinib daily
11147036|NCT01855945|OG000|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11147037|NCT01855945|OG002|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10882111|NCT00470847|EG001|Reported Event|Dose Level 1|n=3 participants 1000 mg lapatinib daily
10882112|NCT00470847|EG002|Reported Event|Dose Level 3|n=5 participants 1500 mg lapatinib daily
10882113|NCT00471068|BG000|Baseline|Travatan|
10882114|NCT00471068|BG001|Baseline|Cosopt|
10882115|NCT00471068|BG002|Baseline|Total|Total of all reporting groups
10882116|NCT00471068|FG000|Participant Flow|Travatan|
10882117|NCT00471068|FG001|Participant Flow|Cosopt|
10882118|NCT00471068|OG000|Outcome|Travatan|
11147038|NCT01855945|OG003|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11147039|NCT01855945|OG005|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10882119|NCT00471068|OG001|Outcome|Cosopt|
10882120|NCT00471068|EG000|Reported Event|Travatan|
10882121|NCT00471068|EG001|Reported Event|Cosopt|
10882122|NCT00471081|BG000|Baseline|GSK 134612 1 Dose Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
11147040|NCT01855945|OG006|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11225296|NCT02367066|BG000|Baseline|AZD1981-Placebo|Sequence AZD1981-Placebo
11225297|NCT02367066|BG001|Baseline|Placebo-AZD1981|Sequence Placebo-AZD1981
11147041|NCT01855945|OG008|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147042|NCT01855945|OG009|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
10882123|NCT00471081|BG001|Baseline|GSK 134612 2 Doses Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
10882124|NCT00471081|BG002|Baseline|Total|Total of all reporting groups
10882125|NCT00471081|FG000|Participant Flow|GSK 134612 1 Dose Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
10882126|NCT00471081|FG001|Participant Flow|GSK 134612 2 Doses Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
11147043|NCT01855945|OG010|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147044|NCT01855945|OG011|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147045|NCT01855945|OG011|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147046|NCT01855945|OG006|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11147047|NCT01855945|OG007|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
10882127|NCT00471081|OG000|Outcome|GSK 134612 1 Dose Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
10882128|NCT00471081|OG001|Outcome|GSK 134612 2 Doses Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
10882129|NCT00471081|OG000|Outcome|GSK 134612 2 Doses Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
10882130|NCT00471081|EG000|Reported Event|GSK 134612 1 Dose Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
10882131|NCT00471081|EG001|Reported Event|GSK 134612 2 Doses Group|Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
10882132|NCT00471107|BG000|Baseline|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
10882133|NCT00471107|BG001|Baseline|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
10882134|NCT00471107|BG002|Baseline|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
10882135|NCT00471107|BG003|Baseline|Total|Total of all reporting groups
10882136|NCT00471107|FG000|Participant Flow|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
10882137|NCT00471107|FG001|Participant Flow|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
10882138|NCT00471107|FG002|Participant Flow|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
10882139|NCT00471107|OG000|Outcome|Left Prefrontal Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
10882140|NCT00471107|OG001|Outcome|Left Prefrontal Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
10882141|NCT00471107|OG002|Outcome|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
10882142|NCT00471107|EG000|Reported Event|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
10882143|NCT00471107|EG001|Reported Event|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
10882144|NCT00471107|EG002|Reported Event|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
10882145|NCT00471146|BG000|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10882146|NCT00471146|BG001|Baseline|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10882147|NCT00471146|BG002|Baseline|Total|Total of all reporting groups
10882148|NCT00471146|FG000|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10882149|NCT00471146|FG001|Participant Flow|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10882150|NCT00471146|OG000|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10882151|NCT00471146|OG001|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10882152|NCT00471146|EG000|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10882153|NCT00471146|EG001|Reported Event|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10882154|NCT00471237|BG000|Baseline|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882155|NCT00471237|BG001|Baseline|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882156|NCT00471237|BG002|Baseline|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
11225298|NCT02367066|BG002|Baseline|Total|Total of all reporting groups
11147048|NCT01855945|OG008|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10882157|NCT00471237|BG003|Baseline|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
11147049|NCT01855945|OG009|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11225299|NCT02367066|FG000|Participant Flow|AZD1981-Placebo|Sequence AZD1981-Placebo
11225300|NCT02367066|FG001|Participant Flow|Placebo-AZD1981|Sequence Placebo-AZD1981
10882158|NCT00471237|BG004|Baseline|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
11225301|NCT02367066|OG000|Outcome|AZD1981|AZD1981, oral tablet
11225302|NCT02367066|OG001|Outcome|Placebo|Placebo, oral tablet
11225303|NCT02367066|OG000|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
10882159|NCT00471237|BG005|Baseline|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882160|NCT00471237|BG006|Baseline|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882161|NCT00471237|BG007|Baseline|Total|Total of all reporting groups
10882162|NCT00471237|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (OD) (matching to ronacaleret tablet) and matching placebo once weekly (OW) (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 milligrams (mg) and vitamin D, at least 400 international units (IU), OD in the evening as dietary supplements throughout the study.
10882163|NCT00471237|FG001|Participant Flow|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882164|NCT00471237|FG002|Participant Flow|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882165|NCT00471237|FG003|Participant Flow|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882166|NCT00471237|FG004|Participant Flow|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882167|NCT00471237|FG005|Participant Flow|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882168|NCT00471237|FG006|Participant Flow|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 microgram (mcg), subcutaneous (SC) injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882169|NCT00471237|OG000|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
11348871|NCT04141930|EG000|Reported Event|Study Drug Eligible|"Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant~Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset"
10882170|NCT00471237|OG001|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882171|NCT00471237|OG002|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882172|NCT00471237|OG003|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882173|NCT00471237|OG004|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882174|NCT00471237|OG005|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882175|NCT00471237|OG006|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882176|NCT00471237|OG000|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882177|NCT00471237|OG001|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
11147050|NCT01855945|OG010|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11348872|NCT04142450|BG000|Baseline|CoolSculpting® System|Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session.
10882178|NCT00471237|OG002|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882179|NCT00471237|OG003|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882180|NCT00471237|EG000|Reported Event|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882181|NCT00471237|EG001|Reported Event|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882182|NCT00471237|EG002|Reported Event|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882183|NCT00471237|EG003|Reported Event|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882184|NCT00471237|EG004|Reported Event|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882185|NCT00471237|EG005|Reported Event|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882186|NCT00471237|EG006|Reported Event|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
10882187|NCT00471276|BG000|Baseline|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
10882188|NCT00471276|FG000|Participant Flow|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
10882189|NCT00471276|OG000|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
10882190|NCT00471276|EG000|Reported Event|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
10882191|NCT00471315|BG000|Baseline|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
10882192|NCT00471315|FG000|Participant Flow|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
10882193|NCT00471315|OG000|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
10882194|NCT00471315|EG000|Reported Event|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
10882195|NCT00471328|BG000|Baseline|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
10882196|NCT00471328|BG001|Baseline|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
10882197|NCT00471328|BG002|Baseline|Total|Total of all reporting groups
10882198|NCT00471328|FG000|Participant Flow|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
10882199|NCT00471328|FG001|Participant Flow|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
10882200|NCT00471328|OG000|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
11225304|NCT02367066|OG001|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded glucose and GLP1 infusion)
10882201|NCT00471328|OG001|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
10887156|NCT00499096|EG001|Reported Event|Arm 2|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
11225305|NCT02367066|OG001|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 infusion)
11225306|NCT02367066|OG001|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
11225307|NCT02367066|OG000|Outcome|MMTT|Mixed Meal Tolerance Test (MMTT)
11225308|NCT02367066|EG000|Reported Event|AZD1981|AZD1981, oral tablet
11225309|NCT02367066|EG001|Reported Event|Placebo|Placebo, oral tablet
11225310|NCT02367131|BG000|Baseline|Jardiance|Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
11225311|NCT02367131|FG000|Participant Flow|Jardiance|Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
11225312|NCT02367131|OG000|Outcome|Jardiance|Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
11225313|NCT02367131|EG000|Reported Event|Jardiance|Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
11225314|NCT02367352|BG000|Baseline|Cohort 1 (Dose Escalation Phase)|Alisertib 15 mg, tablet, orally, twice daily, (3 days on/4 days off for 3 weeks) on Days 1 to 3, 8 to 10 and 15 to 17 in 28 day cycles in combination with Paclitaxel 60 mg/m^2, intravenous (IV), on Days 1, 8, and 15 in a 28-day cycle until disease progression or unacceptable toxicity (Up to 22 Cycles).
11225315|NCT02367352|FG000|Participant Flow|Cohort 1 (Dose Escalation Phase)|Alisertib 15 mg, tablet, orally, twice daily, (3 days on/4 days off for 3 weeks) on Days 1 to 3, 8 to 10 and 15 to 17 in 28 day cycles in combination with Paclitaxel 60 mg/m^2, intravenous (IV), on Days 1, 8, and 15 in a 28-day cycle until disease progression or unacceptable toxicity (Up to 22 Cycles).
11225316|NCT02367352|FG001|Participant Flow|Cohort 2 (Dose Escalation Phase)|Alisertib 25 mg, tablet, orally, twice daily, (3 days on/4 days off for 3 weeks) on Days 1 to 3, 8 to 10 and 15 to 17 in 28 day cycles in combination with Paclitaxel 60 mg/m^2, intravenous (IV), on Days 1, 8, and 15 in 28-day cycle until disease progression or unacceptable toxicity. Dose of alisertib will be de-escalated to 20 mg if ≥ 2 participants experience a dose limiting toxicity (DLT).
11225317|NCT02367352|FG002|Participant Flow|Dose Expansion Cohort|Alisertib, MTD/RP2D determined in Dose Escalation Phase, orally, twice daily, (3 days on/4 days off for 3 weeks) on Days 1 to 3, 8 to 10 and 15 to 17 in 28 day cycles in combination with Paclitaxel 60 mg/m^2, IV on Days 1, 8, and 15 in 28-day cycle until disease progression or unacceptable toxicity.
11225318|NCT02367352|OG000|Outcome|Cohort 1 (Dose Escalation Phase)|Alisertib 15 mg, tablet, orally, twice daily, (3 days on/4 days off for 3 weeks) on Days 1 to 3, 8 to 10 and 15 to 17 in 28 day cycles in combination with Paclitaxel 60 mg/m^2, intravenous (IV), on Days 1, 8, and 15 in a 28-day cycle until disease progression or unacceptable toxicity (Up to 22 Cycles).
11342076|NCT03696576|EG000|Reported Event|PhoRTE|"This group will undergo standard PhoRTE therapy.~PhoRTE: Completing of PhoRTE voice therapy."
11009838|NCT01104415|OG000|Outcome|Telotristat Etiprate- Core Phase|Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period.
11147051|NCT01855945|OG011|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10882202|NCT00471328|OG000|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
10882203|NCT00471328|EG000|Reported Event|Nilotinib(Core +Extension)|Patients randomized to 400 mg Nilotinib which was taken orally twice daily. The safety is assessed using these patient's data from both core and extension phase of the study.
10882204|NCT00471328|EG001|Reported Event|Control(Core + Extension)|Patients randomized to control arm, Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose before the study or at the dose of the investigator's choice. The safety is assessed using these patient's data from both core and extension phase of the study.
10882205|NCT00471328|EG002|Reported Event|Crossover Nilotinib Therapy|All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression were included in safety assessment.
10882206|NCT00471354|BG000|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
10882207|NCT00471354|FG000|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
10882208|NCT00471354|OG000|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
10882209|NCT00471354|EG000|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
10882210|NCT00471380|BG000|Baseline|Overall Study Population|
10882211|NCT00471380|FG000|Participant Flow|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
10882212|NCT00471380|FG001|Participant Flow|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
11225319|NCT02367352|OG001|Outcome|Cohort 2 (Dose Escalation Phase)|Alisertib 25 mg, tablet, orally, twice daily, (3 days on/4 days off for 3 weeks) on Days 1 to 3, 8 to 10 and 15 to 17 in 28 day cycles in combination with Paclitaxel 60 mg/m^2, intravenous (IV), on Days 1, 8, and 15 in 28-day cycle until disease progression or unacceptable toxicity. Dose of alisertib will be de-escalated to 20 mg if ≥ 2 participants experience a dose limiting toxicity (DLT).
11225320|NCT02367352|OG000|Outcome|Dose Expansion Cohort|Alisertib, MTD/RP2D determined in Dose Escalation Phase, orally, twice daily, (3 days on/4 days off for 3 weeks) on Days 1 to 3, 8 to 10 and 15 to 17 in 28 day cycles in combination with Paclitaxel 60 mg/m^2, IV on Days 1, 8, and 15 in 28-day cycle until disease progression or unacceptable toxicity.
10882213|NCT00471380|OG000|Outcome|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
10882214|NCT00471380|OG001|Outcome|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
10882215|NCT00471380|EG000|Reported Event|Treatment A|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.).
10882216|NCT00471380|EG001|Reported Event|Treatment B|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
10882217|NCT00471445|BG000|Baseline|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
10882218|NCT00471445|BG001|Baseline|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
10882219|NCT00471445|BG002|Baseline|Total|Total of all reporting groups
10882220|NCT00471445|FG000|Participant Flow|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
10882221|NCT00471445|FG001|Participant Flow|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
10882222|NCT00471445|OG000|Outcome|Ketamine/Amitriptyline NP-H Cream|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
10882223|NCT00471445|OG001|Outcome|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
10882224|NCT00471445|EG000|Reported Event|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
10882225|NCT00471445|EG001|Reported Event|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
10882226|NCT00471497|BG000|Baseline|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
10882227|NCT00471497|BG001|Baseline|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882228|NCT00471497|BG002|Baseline|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882229|NCT00471497|BG003|Baseline|Total|Total of all reporting groups
10882230|NCT00471497|FG000|Participant Flow|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
10882231|NCT00471497|FG001|Participant Flow|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882232|NCT00471497|FG002|Participant Flow|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
11225321|NCT02367352|EG000|Reported Event|Cohort 1 (Dose Escalation Phase)|Alisertib 15 mg, tablet, orally, twice daily, (3 days on/4 days off for 3 weeks) on Days 1 to 3, 8 to 10 and 15 to 17 in 28 day cycles in combination with Paclitaxel 60 mg/m^2, intravenous (IV), on Days 1, 8, and 15 in a 28-day cycle until disease progression or unacceptable toxicity (Up to 22 Cycles).
11225322|NCT02367391|BG000|Baseline|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
10882233|NCT00471497|OG000|Outcome|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
11009839|NCT01104415|OG000|Outcome|Telotristat Etiprate- Extension Period|Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.
11225323|NCT02367391|BG001|Baseline|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
11225324|NCT02367391|BG002|Baseline|Total|Total of all reporting groups
10882234|NCT00471497|OG001|Outcome|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882235|NCT00471497|OG002|Outcome|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882236|NCT00471497|OG000|Outcome|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882237|NCT00471497|OG001|Outcome|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882238|NCT00471497|EG000|Reported Event|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
10882239|NCT00471497|EG001|Reported Event|Nilotinib 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882240|NCT00471497|EG002|Reported Event|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
10882241|NCT00471497|EG003|Reported Event|All Patients|All patients randomized in the study to all 3 arms and received at least one dose of study drug.
10882242|NCT00471536|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10882243|NCT00471536|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
11225325|NCT02367391|FG000|Participant Flow|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
11225326|NCT02367391|FG001|Participant Flow|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
10882244|NCT00471536|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10882245|NCT00471536|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10882246|NCT00471705|BG000|Baseline|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
10882247|NCT00471705|BG001|Baseline|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
10882248|NCT00471705|BG002|Baseline|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
10882249|NCT00471705|BG003|Baseline|Total|Total of all reporting groups
11225327|NCT02367391|OG000|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
11225328|NCT02367391|OG001|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
11225329|NCT02367391|EG000|Reported Event|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
11225330|NCT02367391|EG001|Reported Event|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
11225331|NCT02367430|BG000|Baseline|Critical Time Intervention for Hoarding Disorder|"Patients with Hoarding Disorder received CTI Model~Critical Time Intervention With Buried in Treasures included: Critical Time Intervention and BIT Workshop"
11225332|NCT02367430|FG000|Participant Flow|Critical Time Intervention for Hoarding Disorder|"Patients with Hoarding Disorder received CTI Model~Critical Time Intervention With Buried in Treasures included: Critical Time Intervention and BIT Workshop"
11225333|NCT02367430|OG000|Outcome|Critical Time Intervention for Hoarding Disorder|"Patients with Hoarding Disorder received CTI Model~Critical Time Intervention With Buried in Treasures included: Critical Time Intervention and BIT Workshop"
11225334|NCT02367430|EG000|Reported Event|Critical Time Intervention for Hoarding Disorder|"Patients with Hoarding Disorder received CTI Model~Critical Time Intervention With Buried in Treasures included: Critical Time Intervention and BIT Workshop"
11225335|NCT02367521|BG000|Baseline|Sham Treatment|"Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength~Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength"
10882250|NCT00471705|FG000|Participant Flow|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
10882251|NCT00471705|FG001|Participant Flow|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
10882252|NCT00471705|FG002|Participant Flow|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
10882253|NCT00471705|OG000|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
10882254|NCT00471705|OG001|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
10882255|NCT00471705|OG002|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
11225336|NCT02367521|BG001|Baseline|LFR rTMS|"Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.~Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.~Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength."
10882256|NCT00471705|EG000|Reported Event|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
10882257|NCT00471705|EG001|Reported Event|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
10882258|NCT00471705|EG002|Reported Event|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
10882259|NCT00471718|BG000|Baseline|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
10882260|NCT00471718|FG000|Participant Flow|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
10882261|NCT00471718|OG000|Outcome|ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
10882262|NCT00471718|OG000|Outcome|Phase I/11: ABT-751|Duration of overall response from time measurements are met for CR or PR until date that recurrence or PD is objectively documented
11225337|NCT02367521|BG002|Baseline|Total|Total of all reporting groups
11225338|NCT02367521|FG000|Participant Flow|LFR rTMS|"Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.~Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.~Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength."
11225339|NCT02367521|FG001|Participant Flow|Sham Treatment|"Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength~Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength"
10882263|NCT00471718|OG000|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
10882264|NCT00471718|OG000|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
10882265|NCT00471718|OG000|Outcome|Phase I/11: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
10882266|NCT00471718|EG000|Reported Event|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
10882267|NCT00471822|BG000|Baseline|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
10882268|NCT00471822|FG000|Participant Flow|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
10882269|NCT00471822|OG000|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
10882270|NCT00471822|EG000|Reported Event|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
11147052|NCT01855945|OG006|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
10882271|NCT00471848|BG000|Baseline|Treatment Arm|Antithymocyte globuline with cyclosporin in first line treatment of patients with acquired severe aplastic anaemia and patients with non-severe aplastic anaemia who are transfusion dependent; the results were compared with historical controls from the EBMT database. Patients were matched for age and disease status (NSAA, SAA, VSAA)
10882272|NCT00471848|FG000|Participant Flow|Treatment Arm|Antithymocyte globuline with cyclosporin in first line treatment of patients with acquired severe aplastic anaemia and patients with non-severe aplastic anaemia who are transfusion dependent; the results were compared with historical controls from the European Group for Blood and Marrow Transplantation (EBMT) database. Patients were matched for age and disease status (NSAA, SAA, VSAA)
10882273|NCT00471848|OG000|Outcome|Treatment Arm|"Antithymocyte globuline with cyclosporin in first line treatment of patients with acquired severe aplastic anaemia and patients with non-severe aplastic anaemia who are transfusion dependent~rabbit antithymocyte globulin: 1.5 vials/10kg daily for 5 days"
10882274|NCT00471848|EG000|Reported Event|Experimental: Treament Arm|Antithymocyte globuline with cyclosporin in first line treatment of patients with acquired severe aplastic anaemia and patients with non-severe aplastic anaemia who are transfusion dependent
10882275|NCT00471887|BG000|Baseline|Treatment: CP-675,206 Monoclonal Antibody|"See intervention descriptions~CP-675,206: Patients will receive intravenous administration of CP-675,206 at a dose of 15mg/kg on Day 1 of an every 90 day cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 day period. Patients may receive up to 8 dose (8 cycles) in a 24-month period until progression of disease or intolerable toxicity."
10882276|NCT00471887|FG000|Participant Flow|Treatment: CP-675,206 Monoclonal Antibody.|"See intervention descriptions~CP-675,206: Patients will receive intravenous administration of CP-675,206 at a dose of 15mg/kg on Day 1 of an every 90 day cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 day period. Patients may receive up to 8 dose (8 cycles) in a 24-month period until progression of disease or intolerable toxicity."
10882277|NCT00471887|OG000|Outcome|Treatment: CP-675,206 Monoclonal Antibody|"See intervention descriptions~CP-675,206: Patients will receive intravenous administration of CP-675,206 at a dose of 15mg/kg on Day 1 of an every 90 day cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 day period. Patients may receive up to 8 dose (8 cycles) in a 24-month period until progression of disease or intolerable toxicity."
10882278|NCT00471887|EG000|Reported Event|Treatment-CP-675,206|"See intervention descriptions~CP-675,206: Patients will receive intravenous administration of CP-675,206 at a dose of 15mg/kg on Day 1 of an every 90 day cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 day period. Patients may receive up to 8 dose (8 cycles) in a 24-month period until progression of disease or intolerable toxicity."
10882279|NCT00472030|BG000|Baseline|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
10882280|NCT00472030|BG001|Baseline|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
10882281|NCT00472030|BG002|Baseline|Total|Total of all reporting groups
10882282|NCT00472030|FG000|Participant Flow|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
10882283|NCT00472030|FG001|Participant Flow|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
10882284|NCT00472030|OG000|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
10882285|NCT00472030|OG001|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
11147053|NCT01855945|OG007|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147054|NCT01855945|OG008|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10882286|NCT00472030|OG000|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with Omalizumab on Day 1, Week 2,4,6,8,10,12 and 14.
10882287|NCT00472030|OG001|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
10882288|NCT00472030|OG000|Outcome|Omalizumab Treatment Arm|Research subjects enrolled to the Omalizumab treatment arm will be treated with Omalizumab on Day 1 and at Week 2,4,6,8,10,12,& 14.
10882289|NCT00472030|OG000|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
10882290|NCT00472030|EG000|Reported Event|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
10882291|NCT00472030|EG001|Reported Event|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
10882292|NCT00472056|BG000|Baseline|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
10882293|NCT00472056|BG001|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
10882294|NCT00472056|BG002|Baseline|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
10882295|NCT00472056|BG003|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
10882296|NCT00472056|BG004|Baseline|Total|Total of all reporting groups
11009840|NCT01104415|OG001|Outcome|Telotristat Etiprate- Extension Period|Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.
10882297|NCT00472056|FG000|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
10882298|NCT00472056|FG001|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
10882299|NCT00472056|FG002|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
10882300|NCT00472056|FG003|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
10882301|NCT00472056|OG000|Outcome|Standard Dose Rituximab|Standard dose arm: Rituximab 375 mg/m^2 intravenous on days +1 and +8 after stem cell infusion.
10882302|NCT00472056|OG001|Outcome|High Dose Rituximab|High dose arm: Rituximab 1000mg/m^2 intravenous on days +1 and +8 after stem cell infusion
10882303|NCT00472056|EG000|Reported Event|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
10882304|NCT00472056|EG001|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
10882305|NCT00472056|EG002|Reported Event|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
10882306|NCT00472056|EG003|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
10882307|NCT00472199|BG000|Baseline|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
10882308|NCT00472199|BG001|Baseline|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
10882309|NCT00472199|BG002|Baseline|Total|Total of all reporting groups
10882310|NCT00472199|FG000|Participant Flow|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
10882311|NCT00472199|FG001|Participant Flow|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
10882312|NCT00472199|OG000|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
10882313|NCT00472199|OG001|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
10882314|NCT00472199|EG000|Reported Event|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
10882315|NCT00472199|EG001|Reported Event|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
10882316|NCT00472290|BG000|Baseline|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
10882317|NCT00472290|FG000|Participant Flow|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
10882318|NCT00472290|OG000|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
10882319|NCT00472290|EG000|Reported Event|Romiplostim|
10882320|NCT00472303|BG000|Baseline|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882321|NCT00472303|BG001|Baseline|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882322|NCT00472303|BG002|Baseline|Total|Total of all reporting groups
11337711|NCT03591406|EG001|Reported Event|Iron Sucrose (IS)|"Participants treated with IS given by IV injection or drip infusion~Dosage Form: Sterile solution for injection containing 2% w/v iron~Strength: 5 mL ampoules containing 100 mg iron per ampoule~Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given~Route of administration: IV injection or drip infusion~Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose."
10882323|NCT00472303|FG000|Participant Flow|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882324|NCT00472303|FG001|Participant Flow|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882325|NCT00472303|FG002|Participant Flow|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo received 100 mg tapentadol prolonged release (PR) twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
10882326|NCT00472303|OG000|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
10882327|NCT00472303|OG001|Outcome|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
10882328|NCT00472303|OG002|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
10882329|NCT00472303|OG000|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882330|NCT00472303|OG000|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882331|NCT00472303|OG001|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
10882332|NCT00472303|OG002|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
10882333|NCT00472303|OG000|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882334|NCT00472303|OG000|Outcome|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882335|NCT00472303|OG001|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882336|NCT00472303|OG000|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
10882337|NCT00472303|OG001|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
10882338|NCT00472303|OG001|Outcome|Morphine Controlled Release Titration Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses
10882339|NCT00472303|OG002|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
10882340|NCT00472303|OG003|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily in the titration phase. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
10882341|NCT00472303|OG004|Outcome|Morphine Controlled Release Maintenance Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
10882342|NCT00472303|OG000|Outcome|Tapentadol Extended Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
10882343|NCT00472303|OG001|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
10882344|NCT00472303|OG002|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
10882345|NCT00472303|OG001|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase
10882346|NCT00472303|OG002|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
10882347|NCT00472303|EG000|Reported Event|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882348|NCT00472303|EG001|Reported Event|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
10882349|NCT00472303|EG002|Reported Event|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. The participant continued at the dose that was effective at the end of the Titration Phase.
10882350|NCT00472303|EG003|Reported Event|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
10882351|NCT00472303|EG004|Reported Event|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. The dose that was effective at the end of the Titration Phase.
10882352|NCT00472420|BG000|Baseline|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
10882353|NCT00472420|FG000|Participant Flow|Rituximab Plus (+) Chemotherapy|Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or orally (PO), on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, every 12 hours (q12h) on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
11147055|NCT01855945|OG009|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147056|NCT01855945|OG010|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147057|NCT01855945|OG011|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147058|NCT01855945|OG006|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
10882354|NCT00472420|OG000|Outcome|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
10882355|NCT00472420|EG000|Reported Event|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
10882356|NCT00472446|BG000|Baseline|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882357|NCT00472446|BG001|Baseline|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882358|NCT00472446|BG002|Baseline|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882359|NCT00472446|BG003|Baseline|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882360|NCT00472446|BG004|Baseline|Total|Total of all reporting groups
10882361|NCT00472446|FG000|Participant Flow|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882362|NCT00472446|FG001|Participant Flow|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882363|NCT00472446|FG002|Participant Flow|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882364|NCT00472446|FG003|Participant Flow|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882365|NCT00472446|OG000|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882366|NCT00472446|OG001|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
11067051|NCT01394978|EG001|Reported Event|ProGEL Pleural Air Leak Sealant With Standard Surgical Closure|"ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).~Standard surgical closure (standard closure with, sutures or staples, for example) plus Progel Pleural Air Leak Sealant."
10882367|NCT00472446|OG002|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882368|NCT00472446|OG003|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882369|NCT00472446|EG000|Reported Event|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882370|NCT00472446|EG001|Reported Event|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882371|NCT00472446|EG002|Reported Event|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882372|NCT00472446|EG003|Reported Event|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
10882373|NCT00472576|BG000|Baseline|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
10882374|NCT00472576|BG001|Baseline|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
10882375|NCT00472576|BG002|Baseline|Total|Total of all reporting groups
10882376|NCT00472576|FG000|Participant Flow|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
10882377|NCT00472576|FG001|Participant Flow|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
10882378|NCT00472576|OG000|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
10882379|NCT00472576|OG001|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
11009841|NCT01104415|EG000|Reported Event|Telotristat Etiprate- Core Phase|Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period.
11337712|NCT03592121|BG000|Baseline|AB-101|"Apply to both nipple/areola regions approximately 1 hour prior to sexual activity~AB-101: Apply approximately 1 hour prior to sexual activity"
10882380|NCT00472576|EG000|Reported Event|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
10882381|NCT00472576|EG001|Reported Event|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
10882382|NCT00472641|BG000|Baseline|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
10882383|NCT00472641|FG000|Participant Flow|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
10882384|NCT00472641|OG000|Outcome|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
10882385|NCT00472641|EG000|Reported Event|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
10882386|NCT00472732|BG000|Baseline|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
10882387|NCT00472732|BG001|Baseline|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
10882388|NCT00472732|BG002|Baseline|Total|Total of all reporting groups
10882389|NCT00472732|FG000|Participant Flow|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
10882390|NCT00472732|FG001|Participant Flow|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
10882391|NCT00472732|OG000|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
10882392|NCT00472732|OG001|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
10882393|NCT00472732|EG000|Reported Event|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
10882394|NCT00472732|EG001|Reported Event|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
10882395|NCT00472797|BG000|Baseline|New Formulation of Rebif - Non-Titrated|
10882396|NCT00472797|BG001|Baseline|New Formulation of Rebif - Titrated|
10882397|NCT00472797|BG002|Baseline|Total|Total of all reporting groups
11147059|NCT01855945|OG008|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10882398|NCT00472797|FG000|Participant Flow|New Formulation of Rebif - Non-Titrated|The new formulation of rebif is not approved and under investigation in the US
10882399|NCT00472797|FG001|Participant Flow|New Formulation of Rebif - Titrated|The new frmulation of rebif is not approved and under investigation in the US
11147060|NCT01855945|OG009|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
11147061|NCT01855945|EG000|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147062|NCT01855945|EG001|Reported Event|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11147063|NCT01855945|EG002|Reported Event|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
10882400|NCT00472797|OG000|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
10882401|NCT00472797|OG000|Outcome|Non-Titrated|New formulation of rebif
10882402|NCT00472797|OG001|Outcome|Titrated|New formulation of rebif
10882403|NCT00472797|OG002|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
11147064|NCT01855945|EG003|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147065|NCT01855945|EG004|Reported Event|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
10882404|NCT00472797|EG000|Reported Event|Non-Titrated|New formulation of rebif
10882405|NCT00472797|EG001|Reported Event|Titrated|New formulation of rebif
11147066|NCT01855945|EG005|Reported Event|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147067|NCT01855945|EG006|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147068|NCT01855945|EG007|Reported Event|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
10882406|NCT00472797|EG002|Reported Event|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
10882407|NCT00472849|BG000|Baseline|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
10882408|NCT00472849|BG001|Baseline|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
10882409|NCT00472849|BG002|Baseline|Total|Total of all reporting groups
10882410|NCT00472849|FG000|Participant Flow|OFAR (Phase I)|Oxaliplatin starting dose 30 mg/m^2/day over 2 hours on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily intravenous (IV) over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
10882411|NCT00472849|FG001|Participant Flow|OFAR (Phase II)|Oxaliplatin 25 mg/m^2 IV per day (Phase I MTD) on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
10882412|NCT00472849|OG000|Outcome|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
10882413|NCT00472849|OG000|Outcome|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
10882414|NCT00472849|EG000|Reported Event|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
10882415|NCT00472849|EG001|Reported Event|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
10882416|NCT00473083|BG000|Baseline|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
10882417|NCT00473083|BG001|Baseline|Arm 2: Reactive Treatmen|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
10882418|NCT00473083|BG002|Baseline|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
10882419|NCT00473083|BG003|Baseline|Total|Total of all reporting groups
10882420|NCT00473083|FG000|Participant Flow|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
10882421|NCT00473083|FG001|Participant Flow|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
10882422|NCT00473083|FG002|Participant Flow|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
10882423|NCT00473083|OG000|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
11147069|NCT01855945|EG008|Reported Event|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147070|NCT01855945|EG009|Reported Event|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
11147071|NCT01855945|EG010|Reported Event|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
11337713|NCT03592121|BG001|Baseline|Placebo|"Apply to both nipple/areola regions approximately 1 hour prior to sexual activity~Placebo: Apply approximately 1 hour prior to sexual activity"
11337714|NCT03592121|BG002|Baseline|Total|Total of all reporting groups
11337715|NCT03592121|FG000|Participant Flow|AB-101|"Apply to both nipple/areola regions approximately 1 hour prior to sexual activity~AB-101: Apply approximately 1 hour prior to sexual activity"
11147072|NCT01855945|EG011|Reported Event|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
11147073|NCT01855958|BG000|Baseline|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
11147074|NCT01855958|BG001|Baseline|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
11147075|NCT01855958|BG002|Baseline|Total|Total of all reporting groups
11147076|NCT01855958|FG000|Participant Flow|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
11147077|NCT01855958|FG001|Participant Flow|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
11147078|NCT01855958|OG000|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
11147079|NCT01855958|OG001|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
11147080|NCT01855958|OG000|Outcome|DIMST|"The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.~DIMST: The investigators used electro acupuncture of 2 Hz during 30 minutes."
11147081|NCT01855958|OG001|Outcome|Placebo-sham|"The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.~Placebo-sham: Electro acupuncture with rubber electrodes, without current passing."
11147082|NCT01855958|EG000|Reported Event|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
10882424|NCT00473083|OG001|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
10882425|NCT00473083|OG002|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
10882426|NCT00473083|OG000|Outcome|Arm 1: Prophylactic Treatment|"Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
10882427|NCT00473083|OG001|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
10882428|NCT00473083|OG002|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
10882429|NCT00473083|EG000|Reported Event|Arm 1: Rash Prevention|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
10882430|NCT00473083|EG001|Reported Event|Arm 2: Treat Only Upon Initiation of Rash|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
10882431|NCT00473083|EG002|Reported Event|Arm 3: Treat Only if Grade 3 Rash Occurs|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
10882432|NCT00473265|BG000|Baseline|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
10882433|NCT00473265|FG000|Participant Flow|PTH1-84|participants received PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
10882434|NCT00473265|OG000|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
10882435|NCT00473265|EG000|Reported Event|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
10882436|NCT00473330|BG000|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882437|NCT00473330|BG001|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882438|NCT00473330|BG002|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
10882439|NCT00473330|BG003|Baseline|Total|Total of all reporting groups
10882440|NCT00473330|FG000|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882441|NCT00473330|FG001|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882442|NCT00473330|FG002|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882443|NCT00473330|OG000|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
10882444|NCT00473330|OG001|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
10882445|NCT00473330|OG002|Outcome|Sham Injection|Patients received a sham intravitreal injection monthly for 24 months.
10882446|NCT00473330|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
11147083|NCT01855958|EG001|Reported Event|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
10882447|NCT00473330|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882448|NCT00473330|OG002|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
10882449|NCT00473330|OG003|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882450|NCT00473330|OG000|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
10882451|NCT00473330|OG001|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
10882452|NCT00473330|OG003|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
10882453|NCT00473330|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
10882454|NCT00473330|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
10882455|NCT00473330|OG002|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
11147084|NCT01855997|BG000|Baseline|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
10882456|NCT00473330|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882457|NCT00473330|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882458|NCT00473330|OG002|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882459|NCT00473330|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882460|NCT00473330|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882461|NCT00473330|OG002|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882462|NCT00473330|EG000|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
10882463|NCT00473330|EG001|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
10882464|NCT00473330|EG002|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
10882465|NCT00473330|EG003|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
10882466|NCT00473330|EG004|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
10882467|NCT00473330|EG005|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
10882468|NCT00473330|EG006|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
10882469|NCT00473382|BG000|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882470|NCT00473382|BG001|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
11337716|NCT03592121|FG001|Participant Flow|Placebo|"Apply to both nipple/areola regions approximately 1 hour prior to sexual activity~Placebo: Apply approximately 1 hour prior to sexual activity"
10882471|NCT00473382|BG002|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
10882472|NCT00473382|BG003|Baseline|Total|Total of all reporting groups
10882473|NCT00473382|FG000|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882474|NCT00473382|FG001|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882475|NCT00473382|FG002|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
10882476|NCT00473382|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
10882477|NCT00473382|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
10882478|NCT00473382|OG002|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
10882479|NCT00473382|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882480|NCT00473382|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
11009842|NCT01104415|EG001|Reported Event|Telotristat Etiprate- Extension Period|Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.
10882481|NCT00473382|OG002|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
10882482|NCT00473382|OG003|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882483|NCT00473382|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
10882484|NCT00473382|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
10882485|NCT00473382|OG003|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
10887157|NCT00499109|BG000|Baseline|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
11009843|NCT01104493|BG000|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
11009844|NCT01104493|BG001|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
11009845|NCT01104493|BG002|Baseline|Total|Total of all reporting groups
11337717|NCT03592121|OG000|Outcome|AB-101|"Apply to both nipple/areola regions approximately 1 hour prior to sexual activity~AB-101: Apply approximately 1 hour prior to sexual activity"
11337718|NCT03592121|OG001|Outcome|Placebo|"Apply to both nipple/areola regions approximately 1 hour prior to sexual activity~Placebo: Apply approximately 1 hour prior to sexual activity"
10882486|NCT00473382|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive Ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882487|NCT00473382|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882488|NCT00473382|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882489|NCT00473382|OG002|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882490|NCT00473382|OG000|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882491|NCT00473382|OG001|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882492|NCT00473382|OG002|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
10882493|NCT00473382|EG000|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
10882494|NCT00473382|EG001|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
11225340|NCT02367521|OG000|Outcome|LFR rTMS|"Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.~Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.~Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength."
11225341|NCT02367521|OG001|Outcome|Sham Treatment|"Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength~Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength"
11337719|NCT03592121|EG000|Reported Event|AB-101|"Apply to both nipple/areola regions approximately 1 hour prior to sexual activity~AB-101: Apply approximately 1 hour prior to sexual activity"
10882495|NCT00473382|EG002|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
11009846|NCT01104493|FG000|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
11009847|NCT01104493|FG001|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
10882496|NCT00473382|EG003|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
10882497|NCT00473382|EG004|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
11147085|NCT01855997|FG000|Participant Flow|Adult Participants Treated With Peg-IFN|Adult participants with hepatitis B envelope antigen (HBeAg)-positive or -negative chronic hepatitis B (CHB) infection who completed greater than or equal to (≥) 24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
11147086|NCT01855997|OG000|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
11147087|NCT01855997|OG000|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
10882498|NCT00473382|EG005|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
10882499|NCT00473382|EG006|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
10882500|NCT00473434|BG000|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882501|NCT00473434|FG000|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882502|NCT00473434|OG000|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882503|NCT00473434|OG000|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882504|NCT00473434|OG001|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882505|NCT00473434|OG002|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882506|NCT00473434|OG003|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
11147088|NCT01855997|OG000|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
11337720|NCT03592121|EG001|Reported Event|Placebo|"Apply to both nipple/areola regions approximately 1 hour prior to sexual activity~Placebo: Apply approximately 1 hour prior to sexual activity"
10882507|NCT00473434|OG004|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882508|NCT00473434|OG005|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882509|NCT00473434|OG006|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882510|NCT00473434|OG007|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882511|NCT00473434|OG008|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882512|NCT00473434|OG009|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882513|NCT00473434|OG010|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882514|NCT00473434|OG007|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882515|NCT00473434|OG008|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882516|NCT00473434|EG000|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
10882517|NCT00473512|BG000|Baseline|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882518|NCT00473512|BG001|Baseline|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882519|NCT00473512|BG002|Baseline|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882520|NCT00473512|BG003|Baseline|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882521|NCT00473512|BG004|Baseline|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882522|NCT00473512|BG005|Baseline|Total|Total of all reporting groups
10882523|NCT00473512|FG000|Participant Flow|250 mg/Day|Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882524|NCT00473512|FG001|Participant Flow|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882525|NCT00473512|FG002|Participant Flow|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882526|NCT00473512|FG003|Participant Flow|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882527|NCT00473512|FG004|Participant Flow|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882528|NCT00473512|OG000|Outcome|1000 mg AA Monotherapy|Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
10882529|NCT00473512|OG001|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
10882530|NCT00473512|OG000|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
10882531|NCT00473512|OG000|Outcome|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882532|NCT00473512|OG001|Outcome|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882533|NCT00473512|OG002|Outcome|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882534|NCT00473512|OG003|Outcome|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882535|NCT00473512|OG004|Outcome|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882536|NCT00473512|OG000|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
10882537|NCT00473512|OG001|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
10882538|NCT00473512|OG002|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
10882539|NCT00473512|OG003|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
10882540|NCT00473512|OG004|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
10887158|NCT00499109|BG001|Baseline|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
10887159|NCT00499109|BG002|Baseline|Total|Total of all reporting groups
10882541|NCT00473512|EG000|Reported Event|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882542|NCT00473512|EG001|Reported Event|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882543|NCT00473512|EG002|Reported Event|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882544|NCT00473512|EG003|Reported Event|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882545|NCT00473512|EG004|Reported Event|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
10882546|NCT00473564|BG000|Baseline|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
10882547|NCT00473564|FG000|Participant Flow|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
11147089|NCT01855997|OG000|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
11147090|NCT01855997|OG000|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
10882548|NCT00473564|OG000|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
10882549|NCT00473564|EG000|Reported Event|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
10882550|NCT00473590|BG000|Baseline|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
11147091|NCT01855997|OG000|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
10882551|NCT00473590|BG001|Baseline|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
10882552|NCT00473590|BG002|Baseline|Total|Total of all reporting groups
10882553|NCT00473590|FG000|Participant Flow|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
10882554|NCT00473590|FG001|Participant Flow|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
11147092|NCT01855997|OG000|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
11147093|NCT01855997|OG000|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
10882555|NCT00473590|OG000|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
10882556|NCT00473590|OG001|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
10882557|NCT00473590|EG000|Reported Event|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
10882558|NCT00473590|EG001|Reported Event|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
10882559|NCT00473642|BG000|Baseline|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
10882560|NCT00473642|BG001|Baseline|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
10882561|NCT00473642|BG002|Baseline|Ranibizumab|Ranibizumab monotherapy
10882562|NCT00473642|BG003|Baseline|Total|Total of all reporting groups
10882563|NCT00473642|FG000|Participant Flow|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
10882564|NCT00473642|FG001|Participant Flow|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
10882565|NCT00473642|FG002|Participant Flow|Ranibizumab|Ranibizumab monotherapy
10882566|NCT00473642|OG000|Outcome|Standard Fluence PDT|"Standard Fluence Photodynamic Therapy combined with ranibizumab~Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL~Verteporfin: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)"
10882567|NCT00473642|OG001|Outcome|Reduced Fluence PDT|"Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab~Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL~Verteporfin: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)"
10882568|NCT00473642|OG002|Outcome|Ranibizumab Monotherapy|"Ranibizumab monotherapy~Ranibizumab: intravitreal administered ranibizumab 0.5 mg in 0.05 mL"
10882569|NCT00473642|OG000|Outcome|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
10882570|NCT00473642|OG001|Outcome|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
10882571|NCT00473642|OG002|Outcome|Ranibizumab|Ranibizumab monotherapy
10882572|NCT00473642|EG000|Reported Event|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
10882573|NCT00473642|EG001|Reported Event|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
10882574|NCT00473642|EG002|Reported Event|Ranibizumab|Ranibizumab monotherapy
10882575|NCT00473655|BG000|Baseline|Rosuvastatin 10 mg|Rosuvastatin 10 mg
10882576|NCT00473655|BG001|Baseline|Rosuvastatin 20 mg|Rosuvastatin 20 mg
10882577|NCT00473655|BG002|Baseline|Placebo|Placebo
10882578|NCT00473655|BG003|Baseline|Total|Total of all reporting groups
10882579|NCT00473655|FG000|Participant Flow|Rosuvastatin 10 mg|Rosuvastatin 10 mg
10882580|NCT00473655|FG001|Participant Flow|Rosuvastatin 20 mg|Rosuvastatin 20 mg
10882581|NCT00473655|FG002|Participant Flow|Placebo|Placebo
10882582|NCT00473655|OG000|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
10882583|NCT00473655|OG001|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
10882584|NCT00473655|OG002|Outcome|Placebo|Placebo
10882585|NCT00473655|EG000|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg
10882586|NCT00473655|EG001|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg
10882587|NCT00473655|EG002|Reported Event|Placebo|Placebo
10882588|NCT00473668|BG000|Baseline|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882589|NCT00473668|BG001|Baseline|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882590|NCT00473668|BG002|Baseline|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882591|NCT00473668|BG003|Baseline|Total|Total of all reporting groups
10882592|NCT00473668|FG000|Participant Flow|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882593|NCT00473668|FG001|Participant Flow|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882594|NCT00473668|FG002|Participant Flow|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882595|NCT00473668|OG000|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882596|NCT00473668|OG001|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882597|NCT00473668|OG002|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882598|NCT00473668|EG000|Reported Event|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882599|NCT00473668|EG001|Reported Event|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
11147094|NCT01855997|OG000|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
11147095|NCT01855997|EG000|Reported Event|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection, and who had completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
11147096|NCT01856114|BG000|Baseline|Intervention Group (Fentanyl Buccal Tablet)|Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
11147097|NCT01856114|BG001|Baseline|Controlled Group (Placebo)|Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
11147098|NCT01856114|BG002|Baseline|Total|Total of all reporting groups
11147099|NCT01856114|FG000|Participant Flow|Intervention Group (Fentanyl Buccal Tablet)|Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
11147100|NCT01856114|FG001|Participant Flow|Controlled Group (Placebo)|Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
11147101|NCT01856114|OG000|Outcome|Intervention Group (Fentanyl Buccal Tablet)|Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
10882600|NCT00473668|EG002|Reported Event|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
10882601|NCT00473694|BG000|Baseline|Rocuronium+Sugammadex|Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
10882602|NCT00473694|BG001|Baseline|Rocuronium+Neostigmine|Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
10882603|NCT00473694|BG002|Baseline|Vecuronium+Sugammadex|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
10882604|NCT00473694|BG003|Baseline|Vecuronium+Neostigmine|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
11147102|NCT01856114|OG001|Outcome|Controlled Group (Placebo)|Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
11147103|NCT01856114|EG000|Reported Event|Intervention Group (Fentanyl Buccal Tablet)|Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
11147104|NCT01856114|EG001|Reported Event|Controlled Group (Placebo)|"Received Placebo tablet 30 minutes before 2nd 6 minute walk test.~."
11147105|NCT01856218|BG000|Baseline|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
11147106|NCT01856218|FG000|Participant Flow|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 every other week (QOW) for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
11348873|NCT04142450|FG000|Participant Flow|CoolSculpting® System|Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session.
10882605|NCT00473694|BG004|Baseline|Total|Total of all reporting groups
10882606|NCT00473694|FG000|Participant Flow|Rocuronium+Sugammadex|Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
10882607|NCT00473694|FG001|Participant Flow|Rocuronium+Neostigmine|Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .
10882608|NCT00473694|FG002|Participant Flow|Vecuronium+Sugammadex|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
10882609|NCT00473694|FG003|Participant Flow|Vecuronium+Neostigmine|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .
10882610|NCT00473694|OG000|Outcome|Rocuronium+Sugammadex|Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
10882611|NCT00473694|OG001|Outcome|Rocuronium+Neostigmine|Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
10882612|NCT00473694|OG000|Outcome|Vecuronium+Sugammadex|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
11147107|NCT01856218|OG000|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
11147108|NCT01856218|EG000|Reported Event|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
11147109|NCT01856257|BG000|Baseline|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
11337721|NCT03592745|BG000|Baseline|Active tVNS + Robotic Arm Therapy|"Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.~Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear."
10882613|NCT00473694|OG001|Outcome|Vecuronium+Neostigmine|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
10882614|NCT00473694|OG002|Outcome|Vecuronium+Sugammadex|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
10882615|NCT00473694|OG003|Outcome|Vecuronium+Neostigmine|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
10882616|NCT00473694|OG003|Outcome|Vecuronium+Neostigmine|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .
11147110|NCT01856257|BG001|Baseline|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
11342077|NCT03696576|EG001|Reported Event|PhoRTE + EMST|"This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.~EMST: Training of the respiratory system muscles using the EMST device.~PhoRTE: Completing of PhoRTE voice therapy."
11009848|NCT01104493|OG000|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
10882617|NCT00473694|EG000|Reported Event|Rocuronium+Sugammadex|Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
10882618|NCT00473694|EG001|Reported Event|Rocuronium+Neostigmine|Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
10882619|NCT00473694|EG002|Reported Event|Vecuronium+Sugammadex|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
10882620|NCT00473694|EG003|Reported Event|Vecuronium+Neostigmine|Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
10882621|NCT00473746|BG000|Baseline|Phase 1 250 MG/DAY|Abiraterone acetate
10882622|NCT00473746|BG001|Baseline|Phase 1 500 MG/DAY|Abiraterone acetate
10882623|NCT00473746|BG002|Baseline|Phase 1 750 MG/DAY|Abiraterone acetate
10882624|NCT00473746|BG003|Baseline|Phase 1 1000 MG/DAY|Abiraterone acetate
10882625|NCT00473746|BG004|Baseline|Phase 2 1000 MG/DAY|Abiraterone acetate
10882626|NCT00473746|BG005|Baseline|Total|Total of all reporting groups
10882627|NCT00473746|FG000|Participant Flow|Phase 1 250 MG/DAY|Abiraterone acetate
10882628|NCT00473746|FG001|Participant Flow|Phase 1 500 MG/DAY|Abiraterone acetate
10882629|NCT00473746|FG002|Participant Flow|Phase 1 750 MG/DAY|Abiraterone acetate
10882630|NCT00473746|FG003|Participant Flow|Phase 1 1000 MG/DAY|Abiraterone acetate
10882631|NCT00473746|FG004|Participant Flow|Phase 2 1000 MG/DAY|Abiraterone acetate
10882632|NCT00473746|OG000|Outcome|Phase I Dose Escalation|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
10882633|NCT00473746|OG000|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
10882634|NCT00473746|OG000|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
10882635|NCT00473746|OG001|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
10882636|NCT00473746|OG002|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
10882637|NCT00473746|OG003|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
10882638|NCT00473746|OG000|Outcome|Phase II Dose Treatment|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
10882639|NCT00473746|EG000|Reported Event|Phase 1 250 MG/DAY|Abiraterone acetate
10882640|NCT00473746|EG001|Reported Event|Phase 1 500 MG/DAY|Abiraterone acetate
10882641|NCT00473746|EG002|Reported Event|Phase 1 750 MG/DAY|Abiraterone acetate
10882642|NCT00473746|EG003|Reported Event|Phase 1 1000 MG/DAY|Abiraterone acetate
10882643|NCT00473746|EG004|Reported Event|Phase 2 1000 MG/DAY|Abiraterone acetate
10882644|NCT00473824|BG000|Baseline|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
10882645|NCT00473824|BG001|Baseline|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
10882646|NCT00473824|BG002|Baseline|Total|Total of all reporting groups
10882647|NCT00473824|FG000|Participant Flow|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
10882648|NCT00473824|FG001|Participant Flow|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
10882649|NCT00473824|OG000|Outcome|Civacir Treatment Arm|Subjects received Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight, in addition to their standard site specific routine post-tranplant immunosuppressant therapy.
10882650|NCT00473824|OG001|Outcome|No Civacir (Control)|Observation on standard site specific routine post-tranplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%. Standard post-tranplant therapy includes immunosuppressive agents.
10882651|NCT00473824|EG000|Reported Event|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
10882652|NCT00473824|EG001|Reported Event|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
10882653|NCT00473837|BG000|Baseline|Treatment|Subjects initially treated with Co-artemether or Chloroquine &Sulphadoxine/Pyrimathamine, and then continued on weekly chloroquine till day 90
10882654|NCT00473837|BG001|Baseline|Control|Subjects initially treated with Co-artemether or Chloroquine & Sulphadoxine/Pyrimathamine, and then continued on weekly placebo till day 90
10882655|NCT00473837|BG002|Baseline|Total|Total of all reporting groups
10882656|NCT00473837|FG000|Participant Flow|Treatment|Subjects initially treated with Corartemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly chloroquine till day 90.
10882657|NCT00473837|FG001|Participant Flow|Control|Subjects initially treated with Co-artemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly placebo till day 90.
10882658|NCT00473837|OG000|Outcome|Treatment|"Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90~Chloroquine: This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days"
10882659|NCT00473837|OG001|Outcome|Control|"Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90~Placebo: The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul"
10882660|NCT00473837|EG000|Reported Event|Treatment|Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
10882661|NCT00473837|EG001|Reported Event|Control|Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
10882662|NCT00473876|BG000|Baseline|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
10882663|NCT00473876|BG001|Baseline|Placebo|Matched Placebo for 4 months
10882664|NCT00473876|BG002|Baseline|Total|Total of all reporting groups
10882665|NCT00473876|FG000|Participant Flow|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
10882666|NCT00473876|FG001|Participant Flow|Placebo|Matched Placebo for 4 months
10882667|NCT00473876|OG000|Outcome|Metformin Arm|Peak VO2 mean difference between baseline and after 4 months of metformin was analysed
10882668|NCT00473876|OG001|Outcome|Placebo|Peak VO2 mean difference between baseline and after 4 months of placebo
10882669|NCT00473876|OG000|Outcome|Metformin Arm|Assess impact of metformin on submaximal exercise parameters- VE/VCO2 slope (pre-specified end point). The mean VE/VCO2 difference was compared between baseline and after 4 months of metformin.
10882670|NCT00473876|OG001|Outcome|Placebo|Impact of placebo on VE/VCO2 slope.
10882671|NCT00473876|EG000|Reported Event|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
10882672|NCT00473876|EG001|Reported Event|Placebo|Matched Placebo for 4 months
10882673|NCT00473889|BG000|Baseline|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
11348874|NCT04142450|OG000|Outcome|CoolSculpting® System|Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session.
10882674|NCT00473889|BG001|Baseline|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
10882675|NCT00473889|BG002|Baseline|Total|Total of all reporting groups
10882676|NCT00473889|FG000|Participant Flow|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
10882677|NCT00473889|FG001|Participant Flow|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
10882678|NCT00473889|OG000|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
10882679|NCT00473889|OG001|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
10882680|NCT00473889|EG000|Reported Event|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
10882681|NCT00473889|EG001|Reported Event|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
10882682|NCT00474045|BG000|Baseline|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
11009849|NCT01104493|OG001|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
10882683|NCT00474045|BG001|Baseline|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
10882684|NCT00474045|BG002|Baseline|Total|Total of all reporting groups
10882685|NCT00474045|FG000|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
10882686|NCT00474045|FG001|Participant Flow|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
10882687|NCT00474045|OG000|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
10882688|NCT00474045|OG001|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
10882689|NCT00474045|EG000|Reported Event|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
10882690|NCT00474045|EG001|Reported Event|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
10882691|NCT00474058|BG000|Baseline|Rotigotine|Rotigotine transdermal patch
10882692|NCT00474058|BG001|Baseline|Placebo|Placebo transdermal patch
10882693|NCT00474058|BG002|Baseline|Total|Total of all reporting groups
10882694|NCT00474058|FG000|Participant Flow|Rotigotine|Rotigotine transdermal patch
10882695|NCT00474058|FG001|Participant Flow|Placebo|Placebo transdermal patch
10882696|NCT00474058|OG000|Outcome|Rotigotine|Rotigotine transdermal patch
10882697|NCT00474058|OG001|Outcome|Placebo|Placebo transdermal patch
10882698|NCT00474058|EG000|Reported Event|Rotigotine|Rotigotine transdermal patch
11342078|NCT03696589|BG000|Baseline|Physical Activity Coaching|Individuals received 6 sessions of physical activity coaching, delivered either in person or remotely via telehealth
10882699|NCT00474058|EG001|Reported Event|Placebo|Placebo transdermal patch
10882700|NCT00474123|BG000|Baseline|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
10882701|NCT00474123|BG001|Baseline|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
10882702|NCT00474123|BG002|Baseline|Total|Total of all reporting groups
10882703|NCT00474123|FG000|Participant Flow|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
10882704|NCT00474123|FG001|Participant Flow|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
10882705|NCT00474123|OG000|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
10882706|NCT00474123|OG001|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
10882707|NCT00474123|EG000|Reported Event|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
10882708|NCT00474123|EG001|Reported Event|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
10882709|NCT00474175|BG000|Baseline|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
10882710|NCT00474175|BG001|Baseline|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
10882711|NCT00474175|BG002|Baseline|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
10882712|NCT00474175|BG003|Baseline|Total|Total of all reporting groups
11342079|NCT03696589|FG000|Participant Flow|Physical Activity Coaching|Individuals received 6 sessions of physical activity coaching, delivered either in person or remotely via telehealth
11342080|NCT03696589|OG000|Outcome|Physical Activity Coaching - Pretest|Baseline Pretest
11342081|NCT03696589|OG001|Outcome|Physical Activity Coaching - Posttest|4 month posttest
11342082|NCT03696589|OG000|Outcome|Physical Activity Coaching - Pretest|Baseline pre-test assessment
10882713|NCT00474175|FG000|Participant Flow|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
10882714|NCT00474175|FG001|Participant Flow|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
10882715|NCT00474175|FG002|Participant Flow|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
10882716|NCT00474175|OG000|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
10882717|NCT00474175|OG001|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
10882718|NCT00474175|OG002|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
10882719|NCT00474175|EG000|Reported Event|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
10882720|NCT00474175|EG001|Reported Event|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
10882721|NCT00474175|EG002|Reported Event|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
10882722|NCT00474201|BG000|Baseline|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
10882723|NCT00474201|FG000|Participant Flow|Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected to determine gemfibrozil plasma concentrations. These plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameter values such as area under the concentration vs. time curve (AUC). Gemfibrozil PK parameter values were then compared before- and after lopinavir-ritonavir administration.
10882724|NCT00474201|OG000|Outcome|Gemfibrozil Alone (Control Group)|"Subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest. After completing participation in this control group, each subject crossed over to received lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days. Therefore, each subject served as their own control. Hence there were two groups of data analyzed, but each group consisted of the same subjects (tested under different conditions)."
10882725|NCT00474201|OG001|Outcome|Gemfibrozil + Lopinavir-ritonavir|After receiving lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days, subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest.
10882726|NCT00474201|EG000|Reported Event|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
11009850|NCT01104493|EG000|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
11009851|NCT01104493|EG001|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
11009852|NCT01104545|BG000|Baseline|Panel A - Healthy|Healthy participants received a single oral dose of MK-3614 0.25 mg, 1.25 mg, 0.25 mg w/ food, 0.75 mg or matching placebo. There was at least a 7-day washout between the 4 dosing periods.
10882727|NCT00474240|BG000|Baseline|Placebo|Placebo capsule taken orally once daily
10882728|NCT00474240|BG001|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
10882729|NCT00474240|BG002|Baseline|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
10882730|NCT00474240|BG003|Baseline|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
10882731|NCT00474240|BG004|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
10882732|NCT00474240|BG005|Baseline|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
10882733|NCT00474240|BG006|Baseline|Total|Total of all reporting groups
10882734|NCT00474240|FG000|Participant Flow|Placebo|Placebo capsule taken orally once daily
10882735|NCT00474240|FG001|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
10882736|NCT00474240|FG002|Participant Flow|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
10882737|NCT00474240|FG003|Participant Flow|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
10882738|NCT00474240|FG004|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
10882739|NCT00474240|FG005|Participant Flow|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
10882740|NCT00474240|OG000|Outcome|Placebo|Placebo capsule taken orally once daily
10882741|NCT00474240|OG001|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
10882742|NCT00474240|OG002|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
10882743|NCT00474240|OG003|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
10882744|NCT00474240|OG004|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
10882745|NCT00474240|OG005|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
10882746|NCT00474240|EG000|Reported Event|Placebo|Placebo capsule taken orally once daily
10882747|NCT00474240|EG001|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
10882748|NCT00474240|EG002|Reported Event|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
10882749|NCT00474240|EG003|Reported Event|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
10882750|NCT00474240|EG004|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
10882751|NCT00474240|EG005|Reported Event|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
10882752|NCT00474253|BG000|Baseline|Rocuronium + Sugammadex|Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.
10882753|NCT00474253|BG001|Baseline|Succinylcholine|Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
10882754|NCT00474253|BG002|Baseline|Total|Total of all reporting groups
10882755|NCT00474253|FG000|Participant Flow|Rocuronium + Sugammadex|Participants received a single bolus intravenous (IV) dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg three minutes after the start of rocuronium administration, to reverse the neuromuscular block.
10882756|NCT00474253|FG001|Participant Flow|Succinylcholine|Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
10882757|NCT00474253|OG000|Outcome|Rocuronium + Sugammadex|Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.
10882758|NCT00474253|OG001|Outcome|Succinylcholine|Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
10882759|NCT00474253|EG000|Reported Event|Rocuronium + Sugammadex|Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.
10882760|NCT00474253|EG001|Reported Event|Succinylcholine|Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
10882761|NCT00474266|BG000|Baseline|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
11342083|NCT03696589|OG001|Outcome|Physical Activity Coaching - Posttest|4 month Post-test assessment
10882762|NCT00474266|BG001|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882763|NCT00474266|BG002|Baseline|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
10882764|NCT00474266|BG003|Baseline|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882765|NCT00474266|BG004|Baseline|Total|Total of all reporting groups
10882766|NCT00474266|FG000|Participant Flow|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
10882767|NCT00474266|FG001|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882768|NCT00474266|FG002|Participant Flow|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
10882769|NCT00474266|FG003|Participant Flow|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882770|NCT00474266|OG000|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
10882771|NCT00474266|OG001|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882772|NCT00474266|OG002|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882773|NCT00474266|OG002|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
10882774|NCT00474266|OG003|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882775|NCT00474266|OG003|Outcome|Pooled Group|Subjects from Nimenrix + Priorix-Tetra Group and subjects from Nimenrix Group
10882776|NCT00474266|OG001|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
10882777|NCT00474266|EG000|Reported Event|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
11342084|NCT03696589|OG000|Outcome|Physical Activity Coaching Pretest|Baseline pretest
10882778|NCT00474266|EG001|Reported Event|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882779|NCT00474266|EG002|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
10882780|NCT00474266|EG003|Reported Event|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, one dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
10882781|NCT00474383|BG000|Baseline|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
10882782|NCT00474383|FG000|Participant Flow|Abiraterone Acetate (Main Study)|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
10882783|NCT00474383|FG001|Participant Flow|Arbitarone Acetate (Extension)|Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
10882784|NCT00474383|OG000|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
10882785|NCT00474383|EG000|Reported Event|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
10882786|NCT00474487|BG000|Baseline|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
10882787|NCT00474487|BG001|Baseline|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
10882788|NCT00474487|BG002|Baseline|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
10882789|NCT00474487|BG003|Baseline|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
11341173|NCT03676972|OG000|Outcome|LithoVue Ureteroscope System|"The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.~LithoVue Ureteroscope System: The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes."
10882790|NCT00474487|BG004|Baseline|Total|Total of all reporting groups
10882791|NCT00474487|FG000|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
10882792|NCT00474487|FG001|Participant Flow|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
10882793|NCT00474487|FG002|Participant Flow|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
10882794|NCT00474487|FG003|Participant Flow|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
11009853|NCT01104545|BG001|Baseline|Panel B - Healthy|Healthy participants received a single oral dose of MK-3614 0.5 mg, 0.75 mg, 0.25 mg twice a day (b.i.d.), 0.25 mg three times a day (t.i.d), or matching placebo. There was at least a 7-day washout between the 4 dosing periods.
11009854|NCT01104545|BG002|Baseline|Panel C - Hypertensive|Hypertensive participants received a single oral dose of MK-3614 0.75 mg, 0.5 mg, 0.75 mg, 0.75 mg or matching placebo. There was at least a 7-day washout between the 4 dosing periods.
11009855|NCT01104545|BG003|Baseline|Total|Total of all reporting groups
11009856|NCT01104545|FG000|Participant Flow|Panel A - Healthy|Healthy participants received a single oral dose of MK-3614 0.25 mg, 1.25 mg, 0.25 mg w/ food, 0.75 mg or matching placebo. There was at least a 7-day washout between the 4 dosing periods.
10882795|NCT00474487|OG000|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
10882796|NCT00474487|OG001|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
10882797|NCT00474487|OG001|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
10882798|NCT00474487|OG001|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly.
10882799|NCT00474487|EG000|Reported Event|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
10882800|NCT00474487|EG001|Reported Event|Novartis MenACWY Vaccine (56 to 65 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
11009857|NCT01104545|FG001|Participant Flow|Panel B - Healthy|Healthy participants received a single oral dose of MK-3614 0.5 mg, 0.75 mg, 0.25 mg twice a day (b.i.d.), 0.25 mg three times a day (t.i.d), or matching placebo. There was at least a 7-day washout between the 4 dosing periods.
10882801|NCT00474487|EG002|Reported Event|Licensed Conjugate Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly in ages 19 to 55 years.
10882802|NCT00474487|EG003|Reported Event|Licensed Polysaccharide Vaccine (56 to 65 Years)|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly (Ages 56 to 65 Years)
10882803|NCT00474526|BG000|Baseline|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
10882804|NCT00474526|BG001|Baseline|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
10882805|NCT00474526|BG002|Baseline|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882806|NCT00474526|BG003|Baseline|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
10882807|NCT00474526|BG004|Baseline|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882808|NCT00474526|BG005|Baseline|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
10882809|NCT00474526|BG006|Baseline|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
10882810|NCT00474526|BG007|Baseline|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
10882811|NCT00474526|BG008|Baseline|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
10882812|NCT00474526|BG009|Baseline|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882813|NCT00474526|BG010|Baseline|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
10882814|NCT00474526|BG011|Baseline|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
10882815|NCT00474526|BG012|Baseline|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
10882816|NCT00474526|BG013|Baseline|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
10882817|NCT00474526|BG014|Baseline|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
10882818|NCT00474526|BG015|Baseline|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
10882819|NCT00474526|BG016|Baseline|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
10882820|NCT00474526|BG017|Baseline|TOTAL|Total of all reporting groups
11342085|NCT03696589|OG001|Outcome|Physical Activity Coaching Posttest|4 months posttest
11342086|NCT03696589|OG000|Outcome|Physical Activity Coaching Pretest|Baseline Pre-test
11342087|NCT03696589|OG001|Outcome|Physical Activity Coaching Posttest|4 months post-test
10882821|NCT00474526|FG000|Participant Flow|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
10882822|NCT00474526|FG001|Participant Flow|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
10882823|NCT00474526|FG002|Participant Flow|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882824|NCT00474526|FG003|Participant Flow|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
10882825|NCT00474526|FG004|Participant Flow|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882826|NCT00474526|FG005|Participant Flow|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
10882827|NCT00474526|FG006|Participant Flow|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
10882828|NCT00474526|FG007|Participant Flow|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
10882829|NCT00474526|FG008|Participant Flow|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
10882830|NCT00474526|FG009|Participant Flow|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882831|NCT00474526|FG010|Participant Flow|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
10882832|NCT00474526|FG011|Participant Flow|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
10882833|NCT00474526|FG012|Participant Flow|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
10882834|NCT00474526|FG013|Participant Flow|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
10882835|NCT00474526|FG014|Participant Flow|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
10882836|NCT00474526|FG015|Participant Flow|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
10882837|NCT00474526|FG016|Participant Flow|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
10882838|NCT00474526|OG000|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
11342088|NCT03696589|OG000|Outcome|Physical Activity Coaching Posttest|4 months posttest
11341207|NCT03678103|OG000|Outcome|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor~INVSENSOR00029: Noninvasive pulse oximeter sensor"
11341208|NCT03678103|EG000|Reported Event|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor~INVSENSOR00029: Noninvasive pulse oximeter sensor"
11342089|NCT03696589|OG000|Outcome|Physical Activity Coaching Posttest|4 month posttest
11147111|NCT01856257|BG002|Baseline|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
11147112|NCT01856257|BG003|Baseline|Total|Total of all reporting groups
11147113|NCT01856257|FG000|Participant Flow|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
10882839|NCT00474526|OG001|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
10882840|NCT00474526|OG000|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
10882841|NCT00474526|OG001|Outcome|US1B (MenACWY-CRM + Infant Vaccines )|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
10882842|NCT00474526|OG002|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
10882843|NCT00474526|OG003|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882844|NCT00474526|OG004|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
10882845|NCT00474526|OG005|Outcome|US4 (Infant Vaccines Only )|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
10882846|NCT00474526|OG006|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
10882847|NCT00474526|OG007|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882848|NCT00474526|OG008|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
10882849|NCT00474526|OG009|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
10882850|NCT00474526|OG010|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
11009858|NCT01104545|FG002|Participant Flow|Panel C - Hypertensive|Hypertensive participants received a single oral dose of MK-3614 0.75 mg, 0.5 mg, 0.75 mg, 0.75 mg or matching placebo. There was at least a 7-day washout between the 4 dosing periods.
11341209|NCT03678285|BG000|Baseline|HIFRT Workout|"Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.~HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout."
11341210|NCT03678285|FG000|Participant Flow|HIFRT Workout|"Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.~HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout."
11342090|NCT03696589|EG000|Reported Event|Physical Activity Coaching|Individuals received 6 sessions of physical activity coaching, delivered either in person or remotely via telehealth
10882851|NCT00474526|OG011|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
10882852|NCT00474526|OG001|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
10882853|NCT00474526|OG005|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
10882854|NCT00474526|OG006|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
10882855|NCT00474526|OG007|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
10882856|NCT00474526|OG008|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
10882857|NCT00474526|OG009|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
10882858|NCT00474526|OG000|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
10882859|NCT00474526|OG002|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled. In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
10882860|NCT00474526|OG003|Outcome|US2 + US4A (Infant Vaccines Only)|"Groups Infant Vaccines only (US2 and US4A) pooled.~In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age."
10882861|NCT00474526|OG005|Outcome|US4B + US4C (Infant Vaccines Only)|"Groups Infant Vaccines only (US4B and US4C) pooled.~Infant Vaccines only (US4B): US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either received one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B); or one dose at 18 months of age (US4C)."
10882862|NCT00474526|OG006|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
10882863|NCT00474526|OG007|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
10882864|NCT00474526|OG008|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882865|NCT00474526|OG009|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
10882866|NCT00474526|OG010|Outcome|LA6B + LA6C (Infant Vaccines Only)|"Groups Infant Vaccines only LA6B and LA6C pooled.~Infant Vaccines only (LA6B): LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
10882867|NCT00474526|OG000|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
11009859|NCT01104545|OG000|Outcome|0.25 mg MK-3614 Panel A|Participants received a single oral dose of 0.25 mg MK-3614 after an 8-hour fast
11009860|NCT01104545|OG001|Outcome|1.25 mg MK-3614 Panel A|Participants received a single oral dose of 1.25 mg MK-3614 after an 8-hour fast
10882868|NCT00474526|OG001|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled.In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
10882869|NCT00474526|OG002|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882870|NCT00474526|OG003|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
10882871|NCT00474526|OG004|Outcome|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
11147114|NCT01856257|FG001|Participant Flow|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
11147115|NCT01856257|FG002|Participant Flow|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
11147116|NCT01856257|FG003|Participant Flow|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
11147117|NCT01856257|OG000|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
11147118|NCT01856257|OG001|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
10882872|NCT00474526|OG005|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
10882873|NCT00474526|OG006|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
10882874|NCT00474526|OG007|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882875|NCT00474526|OG008|Outcome|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
10882876|NCT00474526|OG009|Outcome|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
11009861|NCT01104545|OG002|Outcome|0.25 mg w/ Food MK-3614 Panel A|Participants received a single oral dose of 0.25 mg MK-3614 after ingesting a high-fat breakfest
10882877|NCT00474526|OG011|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
10882878|NCT00474526|OG012|Outcome|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
10882879|NCT00474526|OG000|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882880|NCT00474526|OG001|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
10882881|NCT00474526|OG002|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882882|NCT00474526|OG003|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
10882883|NCT00474526|OG000|Outcome|US1 + US3 (Men ACWY-CRM + Infant Vaccines)|"Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled.~US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B)."
10882884|NCT00474526|OG001|Outcome|US2 + US4 (Infant Vaccines Only)|"Groups Infant Vaccines only (US2+US4) pooled~US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:~either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A); or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and one dose at 15 months of age (US4B); or one dose of MenACWY at 18 months of age (US4C)."
10882885|NCT00474526|OG002|Outcome|LA3 + LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled.~LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
11150117|NCT01875861|BG000|Baseline|Intervention|"Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.~Evidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase."
10882886|NCT00474526|OG003|Outcome|LA4 + LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
10882887|NCT00474526|OG000|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
10882888|NCT00474526|OG001|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
11150118|NCT01875861|BG001|Baseline|Comparison|"Usual care with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components."
11150119|NCT01875861|BG002|Baseline|Total|Total of all reporting groups
10882889|NCT00474526|OG002|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
11009862|NCT01104545|OG003|Outcome|0.75 mg MK-3614 Panel A|Participants received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
11348875|NCT04142450|EG000|Reported Event|CoolSculpting® System|Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session.
11009863|NCT01104545|OG004|Outcome|Placebo Panel A|Participants received a single oral dose of placebo for MK-3614 after an 8-hour fast
10882890|NCT00474526|OG003|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
10882891|NCT00474526|OG001|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
10882892|NCT00474526|OG002|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled~LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
10882893|NCT00474526|OG000|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and received,as part of routine infant vaccination schedule, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group US1 was randomized into subgroups US1A and US1B.
10882894|NCT00474526|OG001|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
10882895|NCT00474526|OG000|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
10882896|NCT00474526|OG001|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
10882897|NCT00474526|OG000|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
10882898|NCT00474526|OG000|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
10882899|NCT00474526|OG001|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882900|NCT00474526|OG000|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
10882901|NCT00474526|OG001|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882902|NCT00474526|OG002|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
10882903|NCT00474526|OG003|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
10882904|NCT00474526|OG000|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
10882905|NCT00474526|OG001|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
11009864|NCT01104545|OG005|Outcome|0.5 mg MK-3614 Panel B|Participants received a single oral dose of 0.50 mg MK-3614 after an 8-hour fast
11009865|NCT01104545|OG006|Outcome|0.75 mg MK-3614 Panel B|Participants received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
11225342|NCT02367521|EG000|Reported Event|LFR rTMS|"Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.~Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.~Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength."
11225343|NCT02367521|EG001|Reported Event|Sham Treatment|"Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength~Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength"
10882906|NCT00474526|OG002|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
10882907|NCT00474526|OG003|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
11225344|NCT02367599|BG000|Baseline|Vitamin D Supplement + PrEP|Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks in addition to their PrEP provided through the main study.
11225345|NCT02367599|BG001|Baseline|PrEP Only Matched Group|A cohort of main-study participants will be selected to match subjects enrolled in the sub-study to serve as controls for comparison.
11225346|NCT02367599|BG002|Baseline|Total|Total of all reporting groups
11225347|NCT02367599|FG000|Participant Flow|Vitamin D Supplement + PrEP|Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 weeks in addition to their PrEP provided through the parent trial.
11225348|NCT02367599|FG001|Participant Flow|PrEP Only Matched Group|A cohort of parent trial participants will be selected to match subjects enrolled in the sub-study to serve as comparative controls.
11225349|NCT02367599|OG000|Outcome|Vitamin D Supplement + PrEP|Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 weeks in addition to their PrEP provided through the parent trial.
11225350|NCT02367599|OG001|Outcome|PrEP Only Matched Group|A cohort of parent trial participants will be selected to match subjects enrolled in the sub-study to serve as comparative controls.
11225351|NCT02367599|EG000|Reported Event|Vitamin D Supplement + PrEP|Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks in addition to their PrEP provided through the main study.
11225352|NCT02367599|EG001|Reported Event|PrEP Only Matched Group|A cohort of main-study participants will be selected to match subjects enrolled in the sub-study to serve as controls for comparison.
11225353|NCT02367716|BG000|Baseline|Treatment Arm|"This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial SJM Quartet™ LV lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).~This is a single arm study.~The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016."
11225354|NCT02367716|FG000|Participant Flow|Treatment Arm- St. Jude Medical Quartet™ LV Lead Model 1458Q|"This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial St. Jude Medical (SJM) Quartet™ Left Ventricular (LV) lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).~This is a single arm study.~The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016."
11225355|NCT02367716|OG000|Outcome|Treatment Arm of SJM Quartet™ LV Lead Model 1458Q|Enrolled in the treatment arm were patients implanted with the commercial SJM Quartet™ LV lead model 1458Q and any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
11225356|NCT02367716|OG000|Outcome|Treatment Arm of SJM Quartet™ LV Lead Model 1458Q|Enrolled in the treatment arm were patients implanted with the commercial SJM Quartet™ LV lead model 1458Q implanted and any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
11225357|NCT02367716|EG000|Reported Event|Treatment Arm|"This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial SJM Quartet™ LV lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).~This is a single arm study.~The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016."
11225358|NCT02367729|BG000|Baseline|Neurostimulator|"Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Neurostimulator: Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks."
11009866|NCT01104545|OG007|Outcome|0.25 mg b.i.d. MK-3614 Panel B|Participants received a single daily dose of 0.25 mg MK-3614 b.i.d.
11009867|NCT01104545|OG008|Outcome|0.25 mg t.i.d MK-3614 Panel B|Participants received a single daily oral dose of 0.25 mg MK-3614 t.i.d.
11225359|NCT02367729|BG001|Baseline|Sham Neurostimulator|"Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Sham: Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks."
11225360|NCT02367729|BG002|Baseline|Total|Total of all reporting groups
11225361|NCT02367729|FG000|Participant Flow|Neurostimulator|"Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Neurostimulator: Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks."
11225362|NCT02367729|FG001|Participant Flow|Sham Neurostimulator|"Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Sham: Inactive neurostimulator device (without electrical charge), worn for 5 days each week x 4 weeks."
11225363|NCT02367729|OG000|Outcome|Neurostimulator|"Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Neurostimulator: Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks."
11225364|NCT02367729|OG001|Outcome|Sham Neurostimulator|"Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Sham: Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks."
11225365|NCT02367729|OG001|Outcome|Sham Neurostimulator|"Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Sham: Inactive neurostimulator device (without electrical charge), worn for 5 days each week x 4 weeks."
11225366|NCT02367729|EG000|Reported Event|Neurostimulator|"Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Neurostimulator: Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks."
11225367|NCT02367729|EG001|Reported Event|Sham Neurostimulator|"Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks~Sham: Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks."
11341211|NCT03678285|OG000|Outcome|HIFRT Workout|"Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.~HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout."
10882908|NCT00474526|OG000|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
10882909|NCT00474526|OG001|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
10882910|NCT00474526|OG002|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882911|NCT00474526|OG001|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
11147119|NCT01856257|OG002|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
11147120|NCT01856257|EG000|Reported Event|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
10882912|NCT00474526|OG000|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
10882913|NCT00474526|OG001|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
10882914|NCT00474526|OG000|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
10882915|NCT00474526|OG001|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
10882916|NCT00474526|EG000|Reported Event|US1+US3|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
10882917|NCT00474526|EG001|Reported Event|US2+US4A+US4B|"Groups Infant Vaccines only (US2, US4A, and US4B) pooled.~In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B)"
10882918|NCT00474526|EG002|Reported Event|US4C|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
11225368|NCT02367781|BG000|Baseline|Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)|Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
11009868|NCT01104545|OG009|Outcome|Placebo Panel B|Participants received a single oral dose of placebo for MK-3614 after an 8-hour fast
11009869|NCT01104545|OG000|Outcome|0.75 mg MK-3614 Panel C|Participants received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
10882919|NCT00474526|EG003|Reported Event|LA1+LA3+LA5|"Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled~LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B).~LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received:~Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A)~DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B).~Concomitantly the fourth dose of MenACWY (LA5)."
10882920|NCT00474526|EG004|Reported Event|LA2+4+6AB|Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B).
10882921|NCT00474526|EG005|Reported Event|LA6C|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
10882922|NCT00474539|BG000|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
10882923|NCT00474539|BG001|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
10882924|NCT00474539|BG002|Baseline|Total|Total of all reporting groups
10882925|NCT00474539|FG000|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
11009870|NCT01104545|OG001|Outcome|0.5 mg MK-3614 Panel C|Participants received a single oral dose of 0.5 mg MK-3614 after an 8-hour fast
11147121|NCT01856257|EG001|Reported Event|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
11147122|NCT01856257|EG002|Reported Event|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
11147123|NCT01856257|EG003|Reported Event|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
11147124|NCT01856309|BG000|Baseline|Placebo to 50 mg q4w Due to EE/LE/CO|Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.
11147125|NCT01856309|BG001|Baseline|Placebo to 100 mg q2w Due to EE/LE/CO|Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147126|NCT01856309|BG002|Baseline|Sirukumab 50 mg q4w|Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147127|NCT01856309|BG003|Baseline|Sirukumab 100 mg q2w|Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147128|NCT01856309|BG004|Baseline|Total|Total of all reporting groups
11147129|NCT01856309|FG000|Participant Flow|Placebo to 50 mg q4w Due to EE/LE/CO|Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 milligram (mg) every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.
11147130|NCT01856309|FG001|Participant Flow|Placebo to 100 mg q2w Due to EE/LE/CO|Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147131|NCT01856309|FG002|Participant Flow|Sirukumab 50 mg q4w|Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147132|NCT01856309|FG003|Participant Flow|Sirukumab 100 mg q2w|Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147133|NCT01856309|OG000|Outcome|Placebo to 50 mg q4w Due to EE/LE/CO|Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.
11147134|NCT01856309|OG001|Outcome|Placebo to 100 mg q2w Due to EE/LE/CO|Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147135|NCT01856309|OG002|Outcome|Sirukumab 50 mg q4w|Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147136|NCT01856309|OG003|Outcome|Sirukumab 100 mg q2w|Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147137|NCT01856309|EG000|Reported Event|Placebo to 50 mg q4w Due to EE/LE/CO|Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.
11147138|NCT01856309|EG001|Reported Event|Placebo to 100 mg q2w Due to EE/LE/CO|Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147139|NCT01856309|EG002|Reported Event|Sirukumab 50 mg q4w|Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147140|NCT01856309|EG003|Reported Event|Sirukumab 100 mg q2w|Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
11147141|NCT01856491|BG000|Baseline|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
11147142|NCT01856491|FG000|Participant Flow|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
11147143|NCT01856491|OG000|Outcome|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
11147144|NCT01856491|EG000|Reported Event|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
10850967|NCT03410992|EG004|Reported Event|Bimekizumab 320 mg Q4W/Q8W (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
11009871|NCT01104545|OG002|Outcome|Placebo Panel C|Participants received a single oral dose of placebo for MK-3614 after an 8-hour fast
11009872|NCT01104545|OG004|Outcome|0.5 mg MK-3614 Panel B|Participants received a single oral dose of 0.50 mg MK-3614 after an 8-hour fast
10882926|NCT00474539|FG001|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
10882927|NCT00474539|OG000|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
10882928|NCT00474539|OG001|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
10882929|NCT00474539|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
10882930|NCT00474539|OG001|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
10882931|NCT00474539|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
10882932|NCT00474539|OG003|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
10882933|NCT00474539|OG004|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
10882934|NCT00474539|OG005|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
10882935|NCT00474539|OG006|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
11147145|NCT01856530|BG000|Baseline|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
11147146|NCT01856530|BG001|Baseline|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
11147147|NCT01856530|BG002|Baseline|Total|Total of all reporting groups
10882936|NCT00474539|OG007|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
10882937|NCT00474539|OG001|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2)
10882938|NCT00474539|OG002|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
10882939|NCT00474539|OG003|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
10882940|NCT00474539|OG000|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
10882941|NCT00474539|OG001|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
10882942|NCT00474539|OG002|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
10882943|NCT00474539|OG003|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
10882944|NCT00474539|OG003|Outcome|7vPnC After Toddler Dose|SParticipants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
10882945|NCT00474539|OG001|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
10882946|NCT00474539|OG000|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
10882947|NCT00474539|OG001|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
11009873|NCT01104545|OG005|Outcome|0.75 mg MK-3614 Panel B|Participants received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
11147148|NCT01856530|FG000|Participant Flow|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
10882948|NCT00474539|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
10882949|NCT00474539|EG001|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
10882950|NCT00474539|EG002|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
10882951|NCT00474539|EG003|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
10882952|NCT00474539|EG004|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
10882953|NCT00474539|EG005|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
10882954|NCT00474539|EG006|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
10882955|NCT00474539|EG007|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
10882956|NCT00474617|BG000|Baseline|Participants 18 to 64 Years Old|Participants to receive an intravenous IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882957|NCT00474617|BG001|Baseline|Participants 65 to 74 Years Old|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882958|NCT00474617|BG002|Baseline|Participants 75 Years and Older|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882959|NCT00474617|BG003|Baseline|Total|Total of all reporting groups
10882960|NCT00474617|FG000|Participant Flow|Participants 18 to 64 Years Old|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882961|NCT00474617|FG001|Participant Flow|Participants 65 to 74 Years Old|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882962|NCT00474617|FG002|Participant Flow|Participants 75 Years and Older|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882963|NCT00474617|OG000|Outcome|Participants 18 to 64 Years Old|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882964|NCT00474617|OG001|Outcome|Participants 65 to 74 Years Old|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
11009874|NCT01104545|OG006|Outcome|0.25 mg b.i.d. MK-3614 Panel B|Participants received a single daily dose of 0.25 mg MK-3614 b.i.d.
11147149|NCT01856530|FG001|Participant Flow|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
11147150|NCT01856530|OG000|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
11147151|NCT01856530|OG001|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
10882965|NCT00474617|OG002|Outcome|Participants 75 Years and Older|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882966|NCT00474617|EG000|Reported Event|Participants 18 to 64 Years Old|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882967|NCT00474617|EG001|Reported Event|Participants 65 to 74 Years Old|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882968|NCT00474617|EG002|Reported Event|Participants 75 Years and Older|Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
10882969|NCT00474630|BG000|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
10882970|NCT00474630|BG001|Baseline|Placebo|Placebo
10882971|NCT00474630|BG002|Baseline|Total|Total of all reporting groups
10882972|NCT00474630|FG000|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
10882973|NCT00474630|FG001|Participant Flow|Placebo|Placebo
10882974|NCT00474630|OG000|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
10882975|NCT00474630|OG001|Outcome|Placebo|Placebo
10882976|NCT00474630|OG000|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/ day
10882977|NCT00474630|EG000|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg daily
10882978|NCT00474630|EG001|Reported Event|Placebo|Placebo
10882979|NCT00474708|BG000|Baseline|Venlafaxine XR|75-225 mg per day
10882980|NCT00474708|BG001|Baseline|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
10882981|NCT00474708|BG002|Baseline|Total|Total of all reporting groups
10882982|NCT00474708|FG000|Participant Flow|Venlafaxine XR|75-225 mg per day
10882983|NCT00474708|FG001|Participant Flow|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
10882984|NCT00474708|OG000|Outcome|Venlafaxine XR|75-225 mg per day
10882985|NCT00474708|OG001|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
10882986|NCT00474708|EG000|Reported Event|Venlafaxine XR|75-225 mg per day
10882987|NCT00474708|EG001|Reported Event|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
10882988|NCT00474760|BG000|Baseline|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10882989|NCT00474760|BG001|Baseline|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10882990|NCT00474760|BG002|Baseline|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10882991|NCT00474760|BG003|Baseline|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10882992|NCT00474760|BG004|Baseline|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
10882993|NCT00474760|BG005|Baseline|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
10882994|NCT00474760|BG006|Baseline|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
10882995|NCT00474760|BG007|Baseline|Total|Total of all reporting groups
10882996|NCT00474760|FG000|Participant Flow|Figitumumab 3 mg/kg|Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10882997|NCT00474760|FG001|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10882998|NCT00474760|FG002|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10882999|NCT00474760|FG003|Participant Flow|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883000|NCT00474760|FG004|Participant Flow|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose [RP2D] extension cohort.
10883001|NCT00474760|FG005|Participant Flow|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma [ACC] and sarcoma extension cohort.
10883002|NCT00474760|FG006|Participant Flow|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing's sarcoma family of tumors [ESFT] extension cohort.
10883003|NCT00474760|OG000|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883004|NCT00474760|OG001|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883005|NCT00474760|OG002|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883006|NCT00474760|OG003|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883007|NCT00474760|OG004|Outcome|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
10883008|NCT00474760|OG005|Outcome|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
10883009|NCT00474760|OG006|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
10883010|NCT00474760|OG004|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
10883011|NCT00474760|OG005|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
10883012|NCT00474760|OG000|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
10883013|NCT00474760|OG001|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
10883014|NCT00474760|OG000|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
10883015|NCT00474760|OG000|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration for dose escalation, RP2D extension, and RP2D ACC and sarcoma extension cohorts, 4 weeks in duration for RP2D ESFT extension cohort).
10883016|NCT00474760|OG000|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
10883017|NCT00474760|EG000|Reported Event|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883018|NCT00474760|EG001|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883019|NCT00474760|EG002|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883020|NCT00474760|EG003|Reported Event|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
10883021|NCT00474760|EG004|Reported Event|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
10883022|NCT00474760|EG005|Reported Event|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
10883023|NCT00474760|EG006|Reported Event|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
10883024|NCT00474786|BG000|Baseline|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
11009875|NCT01104545|OG007|Outcome|0.25 mg t.i.d MK-3614 Panel B|Participants received a single daily oral dose of 0.25 mg MK-3614 t.i.d.
10883025|NCT00474786|BG001|Baseline|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
10883026|NCT00474786|BG002|Baseline|Total|Total of all reporting groups
10883027|NCT00474786|FG000|Participant Flow|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
10883028|NCT00474786|FG001|Participant Flow|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
10883029|NCT00474786|OG000|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
10883030|NCT00474786|OG001|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
10883031|NCT00474786|EG000|Reported Event|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
10883032|NCT00474786|EG001|Reported Event|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
10883033|NCT00474812|BG000|Baseline|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
10883034|NCT00474812|FG000|Participant Flow|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
10883035|NCT00474812|OG000|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
10883036|NCT00474812|EG000|Reported Event|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
10883037|NCT00474851|BG000|Baseline|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883038|NCT00474851|BG001|Baseline|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883039|NCT00474851|BG002|Baseline|Total|Total of all reporting groups
10883040|NCT00474851|FG000|Participant Flow|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883041|NCT00474851|FG001|Participant Flow|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883042|NCT00474851|OG000|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883043|NCT00474851|OG001|Outcome|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883044|NCT00474851|OG001|Outcome|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883045|NCT00474851|EG000|Reported Event|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883046|NCT00474851|EG001|Reported Event|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
10883047|NCT00474903|BG000|Baseline|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
10883048|NCT00474903|BG001|Baseline|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
10883049|NCT00474903|BG002|Baseline|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
10883050|NCT00474903|BG003|Baseline|Total|Total of all reporting groups
10883051|NCT00474903|FG000|Participant Flow|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
10883052|NCT00474903|FG001|Participant Flow|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
10883053|NCT00474903|FG002|Participant Flow|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
10883054|NCT00474903|OG000|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
10883055|NCT00474903|OG001|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
10883056|NCT00474903|OG002|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
10883057|NCT00474903|EG000|Reported Event|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
10883058|NCT00474903|EG001|Reported Event|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
10883059|NCT00474903|EG002|Reported Event|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
10883060|NCT00474929|BG000|Baseline|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day;
10883061|NCT00474929|BG001|Baseline|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
11147152|NCT01856530|EG000|Reported Event|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
10883062|NCT00474929|BG002|Baseline|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
10883063|NCT00474929|BG003|Baseline|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
10883064|NCT00474929|BG004|Baseline|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
10883065|NCT00474929|BG005|Baseline|Total|Total of all reporting groups
10883066|NCT00474929|FG000|Participant Flow|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
10883067|NCT00474929|FG001|Participant Flow|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
10883068|NCT00474929|FG002|Participant Flow|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
10883069|NCT00474929|FG003|Participant Flow|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
10883070|NCT00474929|FG004|Participant Flow|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
10883071|NCT00474929|OG000|Outcome|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
11147153|NCT01856530|EG001|Reported Event|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
11225369|NCT02367781|BG001|Baseline|Arm B (Nab-Paclitaxel+Carboplatin)|Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
10883072|NCT00474929|OG001|Outcome|Phase I, Dose Level 1|Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
10883073|NCT00474929|OG002|Outcome|Phase I, Dose Level 2|Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
10883074|NCT00474929|OG003|Outcome|Phase I, Dose Level 3|Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
10883075|NCT00474929|OG000|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|"This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). Due to concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2, the PI felt it was in the best interest of the patients to choose dose level 1 as the MTD and the dose level for Phase II.~Therefore, the analysis of the Phase II endpoint includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77)."
10883076|NCT00474929|OG000|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
10883077|NCT00474929|EG000|Reported Event|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
10883078|NCT00474929|EG001|Reported Event|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
10883079|NCT00474929|EG002|Reported Event|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
10883080|NCT00474929|EG003|Reported Event|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
10883081|NCT00474929|EG004|Reported Event|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
10883082|NCT00474955|BG000|Baseline|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
10883083|NCT00474955|FG000|Participant Flow|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a [Pegasys] [40 kilo Dalton (kDa)], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of <15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
10883084|NCT00474955|OG000|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
10883085|NCT00474955|EG000|Reported Event|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
10883086|NCT00474968|BG000|Baseline|SoftPAP|Samples collected using the SoftPAP Collector
10883087|NCT00474968|BG001|Baseline|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
10883088|NCT00474968|BG002|Baseline|Total|Total of all reporting groups
10883089|NCT00474968|FG000|Participant Flow|SoftPAP|Samples collected using the SoftPAP Collector
10883090|NCT00474968|FG001|Participant Flow|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
10883091|NCT00474968|OG000|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
10883092|NCT00474968|OG001|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
10883093|NCT00474968|EG000|Reported Event|SoftPAP|Samples collected using the SoftPAP Collector
10883094|NCT00474968|EG001|Reported Event|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
10883095|NCT00474994|BG000|Baseline|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
10883096|NCT00474994|FG000|Participant Flow|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
11150120|NCT01875861|FG000|Participant Flow|Intervention|"Evidence-Based Quality Improvement plus external facilitation to promote uptake of quality improvement tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, tools, and improvement strategies relevant to metabolic monitoring and management.~Evidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase."
10883097|NCT00474994|OG000|Outcome|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
10883098|NCT00474994|EG000|Reported Event|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
10883099|NCT00475020|BG000|Baseline|Participants With Myelofibrosis and Myelodysplastic Syndrome|Allogeneic stem cell transplantation (SCT) with preparative regimen of fludarabine and busulfan in myelofibrosis and myelodysplastic syndrome
10883100|NCT00475020|FG000|Participant Flow|Participants With Myelofibrosis and Myelodysplastic Syndrome|Allogeneic stem cell transplantation (SCT) with preparative regimen of fludarabine and busulfan in myelofibrosis and myelodysplastic syndrome
10883101|NCT00475020|OG000|Outcome|Participants With Myelofibrosis and Myelodysplastic Syndrome|Allogeneic stem cell transplantation (SCT) with preparative regimen of fludarabine and busulfan in myelofibrosis and myelodysplastic syndrome
10883102|NCT00475020|EG000|Reported Event|Participants With Myelofibrosis and Myelodysplastic Syndrome|Allogeneic stem cell transplantation (SCT) with preparative regimen of fludarabine and busulfan in myelofibrosis and myelodysplastic syndrome
10883103|NCT00475033|BG000|Baseline|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883104|NCT00475033|BG001|Baseline|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883105|NCT00475033|BG002|Baseline|Total|Total of all reporting groups
11225370|NCT02367781|BG002|Baseline|Total|Total of all reporting groups
10883106|NCT00475033|FG000|Participant Flow|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883107|NCT00475033|FG001|Participant Flow|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883108|NCT00475033|OG000|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883109|NCT00475033|OG001|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883110|NCT00475033|OG000|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883111|NCT00475033|EG000|Reported Event|13vPnC Infant Series|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273."
10883112|NCT00475033|EG001|Reported Event|7vPnC Infant Series|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279."
10883113|NCT00475033|EG002|Reported Event|13vPnC After the Infant Series|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
10883114|NCT00475033|EG003|Reported Event|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
10883115|NCT00475033|EG004|Reported Event|13vPnC Toddler Dose|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199."
11341212|NCT03678285|EG000|Reported Event|HIFRT Workout|"Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.~HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout."
10883116|NCT00475033|EG005|Reported Event|7vPnC Toddler Dose|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193."
10883117|NCT00475033|EG006|Reported Event|13vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883118|NCT00475033|EG007|Reported Event|7vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
10883119|NCT00475085|BG000|Baseline|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883120|NCT00475085|BG001|Baseline|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883121|NCT00475085|BG002|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883122|NCT00475085|BG003|Baseline|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883123|NCT00475085|BG004|Baseline|Total|Total of all reporting groups
11009876|NCT01104545|OG000|Outcome|0.25 mg MK-3614|Participants received single oral dose of 0.25 mg MK-3614 either after an 8 -hour fast or after a high-fat breakfast.
11341213|NCT03678311|BG000|Baseline|Sleep Apnea Ahi > 5|If Sleep Apnea index is > 5 and diagnosed with Long QT Syndrome
10883124|NCT00475085|FG000|Participant Flow|Arm 1 Palonosetron, Dexamethasone, Compazine|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883125|NCT00475085|FG001|Participant Flow|Arm 2 Granisetron, Dexamethasone, Compazine|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883126|NCT00475085|FG002|Participant Flow|Arm 3 Aprepitant, Palonosetron, Dexamethasone|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883127|NCT00475085|FG003|Participant Flow|Arm 4 Palonosetron, Dexamethasone, Compazine, Dexamethasone|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
11147154|NCT01856543|BG000|Baseline|Eucerin|"Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.~Eucerin"
11147155|NCT01856543|BG001|Baseline|Mometasone Furoate 0.1%|"Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.~Mometasone F"
11147156|NCT01856543|BG002|Baseline|Total|Total of all reporting groups
11147157|NCT01856543|FG000|Participant Flow|Eucerin|"Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.~Eucerin"
10883128|NCT00475085|OG000|Outcome|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883129|NCT00475085|OG001|Outcome|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883130|NCT00475085|OG002|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883131|NCT00475085|OG003|Outcome|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
11147158|NCT01856543|FG001|Participant Flow|Mometasone Furoate 0.1%|"Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.~Mometasone F"
10883132|NCT00475085|EG000|Reported Event|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883133|NCT00475085|EG001|Reported Event|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883134|NCT00475085|EG002|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883135|NCT00475085|EG003|Reported Event|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
10883136|NCT00475150|BG000|Baseline|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10883137|NCT00475150|BG001|Baseline|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10883138|NCT00475150|BG002|Baseline|Total|Total of all reporting groups
10883139|NCT00475150|FG000|Participant Flow|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10883140|NCT00475150|FG001|Participant Flow|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10883141|NCT00475150|OG000|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11147159|NCT01856543|OG000|Outcome|Eucerin|"Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.~Eucerin"
11150121|NCT01875861|FG001|Participant Flow|Comparison|"Usual care with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components."
10883142|NCT00475150|OG001|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10883143|NCT00475150|EG000|Reported Event|All Patients Receiving Cediranib Maleate|All patients receiving oral cediranib maleate, regardless of diagnosis were analyzed for toxicity.
10883144|NCT00475176|BG000|Baseline|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
10883145|NCT00475176|FG000|Participant Flow|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks.
10883146|NCT00475176|OG000|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
10883147|NCT00475176|EG000|Reported Event|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
10883148|NCT00475215|BG000|Baseline|Rocuronium + Sugammadex 2.0 mg/kg|After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.
10883149|NCT00475215|BG001|Baseline|Rocuronium + Sugammadex 4.0 mg/kg|After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
10883150|NCT00475215|BG002|Baseline|Total|Total of all reporting groups
10883151|NCT00475215|FG000|Participant Flow|Rocuronium + Sugammadex 2.0 mg/kg|After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.
10883152|NCT00475215|FG001|Participant Flow|Rocuronium + Sugammadex 4.0 mg/kg|After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
10883153|NCT00475215|OG000|Outcome|Rocuronium + Sugammadex 2.0 mg/kg|After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.
10883154|NCT00475215|OG001|Outcome|Rocuronium + Sugammadex 4.0 mg/kg|After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
10883155|NCT00475215|EG000|Reported Event|Rocuronium + Sugammadex 2.0 mg|After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg.
10883156|NCT00475215|EG001|Reported Event|Rocuronium + Sugammadex 4.0 mg|After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
10883157|NCT00475228|BG000|Baseline|Arm I: Immediate LNG-IUD Insertion Group|Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
10883158|NCT00475228|BG001|Baseline|Arm 2: Delayed LNG-IUD Insertion Group|Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
10883159|NCT00475228|BG002|Baseline|Total|Total of all reporting groups
10883160|NCT00475228|FG000|Participant Flow|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
10883161|NCT00475228|FG001|Participant Flow|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
10883162|NCT00475228|OG000|Outcome|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
10883163|NCT00475228|OG001|Outcome|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
10883164|NCT00475228|OG000|Outcome|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD was inserted at standard time post-procedure (3-6 weeks post D&E procedure) in 20 participants. The remaining 24 women did not return 3-6 weeks after the D&E.~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
10883165|NCT00475228|OG001|Outcome|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD was inserted immediately after completion of D&E in all 44 participants~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
10883166|NCT00475228|OG000|Outcome|Arm I: Immediate LNG-IUD Insertion Group|Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
10883167|NCT00475228|OG001|Outcome|Arm 2: Delayed LNG-IUD Insertion Group|Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
10883168|NCT00475228|EG000|Reported Event|Arm I|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
10883169|NCT00475228|EG001|Reported Event|Arm 2|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
10883170|NCT00475241|BG000|Baseline|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
11341214|NCT03678311|FG000|Participant Flow|Sleep Apnea Ahi > 5|"If Sleep Apnea index is > 5 and diagnosed with Long QT Syndrome~Continuous Positive Airway Pressure (CPAP): If diagnosed with Long QT Syndrome and have Sleep Apnea index >5 pauses per hour then given CPAP to wear for approximately 3 months."
10883171|NCT00475241|BG001|Baseline|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
10883172|NCT00475241|BG002|Baseline|Total|Total of all reporting groups
10883173|NCT00475241|FG000|Participant Flow|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
10883174|NCT00475241|FG001|Participant Flow|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
10883175|NCT00475241|OG000|Outcome|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
10883176|NCT00475241|OG001|Outcome|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
10883177|NCT00475241|OG000|Outcome|Prolonged Exposure Therapy|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
10883178|NCT00475241|EG000|Reported Event|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
10883179|NCT00475241|EG001|Reported Event|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
10883180|NCT00475306|BG000|Baseline|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
10883181|NCT00475306|BG001|Baseline|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
10883182|NCT00475306|BG002|Baseline|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
10883183|NCT00475306|BG003|Baseline|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
10883184|NCT00475306|BG004|Baseline|Total|Total of all reporting groups
10883185|NCT00475306|FG000|Participant Flow|Metoclopramide 20 mg+Diphenhydramine|Metoclopramide 20mg co-administered with diphenhydramine 25 mg, intravenously
10883186|NCT00475306|FG001|Participant Flow|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
10883187|NCT00475306|FG002|Participant Flow|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
10883188|NCT00475306|FG003|Participant Flow|Metoclopramide 10+Diphenhydramine|Metoclopramide 10 mg co-administered with diphenhydramine 25 mg, intravenously
11147160|NCT01856543|OG001|Outcome|Mometasone Furoate 0.1%|"Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.~Mometasone F"
11147161|NCT01856543|OG001|Outcome|Mometasone Furoate 0.1%|Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.
10850968|NCT03410992|EG005|Reported Event|Bimekizumab 320 mg Q4W/Q4W (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
10850969|NCT03410992|EG006|Reported Event|Placebo Escape (ESS)|Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS).
10883189|NCT00475306|OG000|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
10883190|NCT00475306|OG001|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
10883191|NCT00475306|OG002|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
10883192|NCT00475306|OG003|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
10883193|NCT00475306|EG000|Reported Event|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
10883194|NCT00475306|EG001|Reported Event|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
10883195|NCT00475306|EG002|Reported Event|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
10883196|NCT00475306|EG003|Reported Event|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
10883197|NCT00475319|BG000|Baseline|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883198|NCT00475319|BG001|Baseline|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883199|NCT00475319|BG002|Baseline|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883200|NCT00475319|BG003|Baseline|Total|Total of all reporting groups
10883201|NCT00475319|FG000|Participant Flow|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883202|NCT00475319|FG001|Participant Flow|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883203|NCT00475319|FG002|Participant Flow|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883204|NCT00475319|OG000|Outcome|1% OPC-12759 Ophthalmic Suspension|1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
10883205|NCT00475319|OG001|Outcome|2% OPC-12759 Ophthalmic Suspension|2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
10883206|NCT00475319|OG002|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
10883207|NCT00475319|OG000|Outcome|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883208|NCT00475319|OG001|Outcome|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883209|NCT00475319|OG002|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883210|NCT00475319|EG000|Reported Event|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883211|NCT00475319|EG001|Reported Event|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883212|NCT00475319|EG002|Reported Event|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
10883213|NCT00475423|BG000|Baseline|Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15.
10883214|NCT00475423|FG000|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15.
10883215|NCT00475423|OG000|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
10883216|NCT00475423|EG000|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
10883217|NCT00475501|BG000|Baseline|Testosterone Vehicle|125 mg testosterone enanthate/week i.m. daily placebo pill
10883218|NCT00475501|BG001|Baseline|Vehicle Finasteride|weekly vehicle injection 5 mg finasteride/day p.o.
10883219|NCT00475501|BG002|Baseline|Testosterone Finasteride|125 mg testosterone enanthate/week i.m. 5 mg finasteride/day p.o.
10883220|NCT00475501|BG003|Baseline|Vehicle Placebo|weekly vehicle injection daily placebo pill
10883221|NCT00475501|BG004|Baseline|Total|Total of all reporting groups
10883222|NCT00475501|FG000|Participant Flow|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
10883223|NCT00475501|FG001|Participant Flow|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
10883224|NCT00475501|FG002|Participant Flow|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
10883225|NCT00475501|FG003|Participant Flow|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
10883226|NCT00475501|OG000|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Measurement of leg press strength, 1-RM"
10883227|NCT00475501|OG001|Outcome|Arm 2|"finasteride~Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks"
10883228|NCT00475501|OG002|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Measurement of leg press strength, 1-RM"
10883229|NCT00475501|OG003|Outcome|Arm 4|"placebo~Measurement of leg press strength, 1-RM"
10883230|NCT00475501|OG000|Outcome|Testosterone Vehicle|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~grip strength measure on a dynamometer"
10883231|NCT00475501|OG001|Outcome|Vehicle Finasteride|grip strength measure on a dynamometer
10883232|NCT00475501|OG002|Outcome|Testosterone Finasteride|grip strength measure on a dynamometer
10883233|NCT00475501|OG003|Outcome|Vehicle Placebo|grip strength measure on a dynamometer
10883234|NCT00475501|OG000|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
10883235|NCT00475501|OG001|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
10883236|NCT00475501|OG002|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
10883237|NCT00475501|OG003|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
10883238|NCT00475501|OG000|Outcome|Testosterone Vehicle|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
10883239|NCT00475501|OG001|Outcome|Vehicle Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
10883240|NCT00475501|OG002|Outcome|Testosterone Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
10883241|NCT00475501|OG003|Outcome|Vehicle Placebo|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
11147162|NCT01856543|EG000|Reported Event|Eucerin|"Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.~Eucerin"
11225371|NCT02367781|FG000|Participant Flow|Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)|Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
11341215|NCT03678311|OG000|Outcome|Sleep Apnea Ahi > 5|If Sleep Apnea index is > 5 and diagnosed with Long QT Syndrome
10883242|NCT00475501|OG000|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
10883243|NCT00475501|OG001|Outcome|Arm 2|"finasteride~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test Finasteride : 5 mg, oral, once/day, for 52 weeks"
10883244|NCT00475501|OG002|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
10883245|NCT00475501|OG003|Outcome|Arm 4|"placebo~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
10883246|NCT00475501|OG000|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Trail Making Test A"
10883247|NCT00475501|OG001|Outcome|Arm 2|"finasteride~Trail Making Test A Finasteride : 5 mg, oral, once/day, for 52 weeks"
10883248|NCT00475501|OG002|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Trail Making Test A"
10883249|NCT00475501|OG003|Outcome|Arm 4|"placebo~Trail Making Test A"
10883250|NCT00475501|OG000|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Benton Test -Judgment of Line Orientation"
10883251|NCT00475501|OG001|Outcome|Arm 2|"finasteride~Benton Test -Judgment of Line Orientation~Finasteride : 5 mg, oral, once/day, for 52 weeks"
10883252|NCT00475501|OG002|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Benton Test -Judgment of Line Orientation"
10883253|NCT00475501|OG003|Outcome|Arm 4|"placebo~Benton Test -Judgment of Line Orientation"
10883254|NCT00475501|OG000|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
10883255|NCT00475501|OG001|Outcome|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
10883256|NCT00475501|OG002|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
10883257|NCT00475501|OG003|Outcome|Arm 4|"placebo~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
10883258|NCT00475501|OG000|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Life Satisfaction A"
10883259|NCT00475501|OG001|Outcome|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks~Life Satisfaction A"
10883260|NCT00475501|OG002|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Life Satisfaction A"
10883261|NCT00475501|OG003|Outcome|Arm 4|"placebo~Life Satisfaction A"
10883262|NCT00475501|EG000|Reported Event|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks"
10883263|NCT00475501|EG001|Reported Event|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks"
10883264|NCT00475501|EG002|Reported Event|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks"
10883265|NCT00475501|EG003|Reported Event|Arm 4|placebo
10883266|NCT00475644|BG000|Baseline|Enzastaurin|Enzastaurin 500 milligram (mg) administered orally (PO) each day (QD) after an initial loading dose of 1125 mg on Day 1.
10883267|NCT00475644|FG000|Participant Flow|Enzastaurin|Enzastaurin 500 milligram (mg) administered orally (PO) each day (QD) after an initial loading dose of 1125 mg on Day 1.
10883268|NCT00475644|OG000|Outcome|Enzastaurin|Enzastaurin 500 milligram (mg) administered orally (PO) each day (QD) after an initial loading dose of 1125 mg on Day 1.
10883269|NCT00475644|EG000|Reported Event|Enzastaurin|Enzastaurin 500 milligram (mg) administered orally (PO) each day (QD) after an initial loading dose of 1125 mg on Day 1.
10883270|NCT00475670|BG000|Baseline|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
10883271|NCT00475670|BG001|Baseline|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
10883272|NCT00475670|BG002|Baseline|Total|Total of all reporting groups
10883273|NCT00475670|FG000|Participant Flow|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
10883274|NCT00475670|FG001|Participant Flow|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/square meter (m^2), IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
10883275|NCT00475670|OG000|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
10883276|NCT00475670|OG001|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
10883277|NCT00475670|EG000|Reported Event|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
10883278|NCT00475670|EG001|Reported Event|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
10883279|NCT00475709|BG000|Baseline|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
10883280|NCT00475709|FG000|Participant Flow|Subjects Implanted With Trifecta Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
10883281|NCT00475709|OG000|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
10883282|NCT00475709|EG000|Reported Event|Subjects Implanted With Trifecta Valve|
10883283|NCT00475722|BG000|Baseline|1 Healthy Eating|"Healthy People 2010 Diet using an exchange list~1 Healthy Eating: 6 months telephone counseling"
11341216|NCT03678311|EG000|Reported Event|Sleep Apnea Ahi >5|Sleep Apnea Index >5 and diagnosed with Long QT Syndrome
11341217|NCT03678870|BG000|Baseline|Education|"Opioid Education~Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge."
10883284|NCT00475722|BG001|Baseline|2 Mediterranean|"Mediterranean Diet using an exchange list~2 Mediterranean: 6 months telephone counseling"
10883285|NCT00475722|BG002|Baseline|Total|Total of all reporting groups
10883286|NCT00475722|FG000|Participant Flow|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
10883287|NCT00475722|FG001|Participant Flow|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
11341218|NCT03678870|BG001|Baseline|Control|Standard discharge instructions, which lists medications prescribed at discharge
10883288|NCT00475722|OG000|Outcome|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
10883289|NCT00475722|OG001|Outcome|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
10883290|NCT00475722|EG000|Reported Event|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
10883291|NCT00475722|EG001|Reported Event|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
10883292|NCT00475735|BG000|Baseline|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
10883293|NCT00475735|BG001|Baseline|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
10883294|NCT00475735|BG002|Baseline|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
10883295|NCT00475735|BG003|Baseline|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
10883296|NCT00475735|BG004|Baseline|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
10883297|NCT00475735|BG005|Baseline|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
10883298|NCT00475735|BG006|Baseline|Total|Total of all reporting groups
10883299|NCT00475735|FG000|Participant Flow|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
10883300|NCT00475735|FG001|Participant Flow|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
10883301|NCT00475735|FG002|Participant Flow|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
10883302|NCT00475735|FG003|Participant Flow|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
10883303|NCT00475735|FG004|Participant Flow|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
10883304|NCT00475735|FG005|Participant Flow|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
10883305|NCT00475735|OG000|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
10883306|NCT00475735|OG001|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
10883307|NCT00475735|OG002|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
10883308|NCT00475735|EG000|Reported Event|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
10883309|NCT00475735|EG001|Reported Event|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
10883310|NCT00475735|EG002|Reported Event|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
10883311|NCT00475787|BG000|Baseline|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
10883312|NCT00475787|BG001|Baseline|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
10883313|NCT00475787|BG002|Baseline|Total|Total of all reporting groups
10883314|NCT00475787|FG000|Participant Flow|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
10883315|NCT00475787|FG001|Participant Flow|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
11341219|NCT03678870|BG002|Baseline|Total|Total of all reporting groups
10883316|NCT00475787|OG000|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
10883317|NCT00475787|OG001|Outcome|Sham Group|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
10883318|NCT00475787|OG000|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
10883319|NCT00475787|OG001|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
11225372|NCT02367781|FG001|Participant Flow|Arm B (Nab-Paclitaxel+Carboplatin)|Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
11225373|NCT02367781|OG000|Outcome|Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)|Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
11225374|NCT02367781|OG001|Outcome|Arm B (Nab-Paclitaxel+Carboplatin)|Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
11341220|NCT03678870|FG000|Participant Flow|Education|"Opioid Education~Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge."
10883320|NCT00475787|EG000|Reported Event|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
10883321|NCT00475787|EG001|Reported Event|Sham Intervention|Detuned Ultrasound
10883322|NCT00475852|BG000|Baseline|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
10883323|NCT00475852|BG001|Baseline|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
10883324|NCT00475852|BG002|Baseline|Total|Total of all reporting groups
10883325|NCT00475852|FG000|Participant Flow|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
10883326|NCT00475852|FG001|Participant Flow|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
10883327|NCT00475852|OG000|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
10883328|NCT00475852|OG001|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
11341221|NCT03678870|FG001|Participant Flow|Control|Standard discharge instructions, which lists medications prescribed at discharge
11341222|NCT03678870|OG000|Outcome|Education|"Opioid Education~Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge."
10883329|NCT00475852|EG000|Reported Event|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
10883330|NCT00475852|EG001|Reported Event|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
10883331|NCT00475865|BG000|Baseline|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883332|NCT00475865|BG001|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883333|NCT00475865|BG002|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883334|NCT00475865|BG003|Baseline|Total|Total of all reporting groups
10883335|NCT00475865|FG000|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
10883336|NCT00475865|FG001|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
10883337|NCT00475865|FG002|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
10883338|NCT00475865|OG000|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883339|NCT00475865|OG001|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883340|NCT00475865|OG002|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883341|NCT00475865|OG000|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883342|NCT00475865|OG001|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883343|NCT00475865|EG000|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883344|NCT00475865|EG001|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883345|NCT00475865|EG002|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
10883346|NCT00475878|BG000|Baseline|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
10883347|NCT00475878|BG001|Baseline|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
10883348|NCT00475878|BG002|Baseline|Total|Total of all reporting groups
10883349|NCT00475878|FG000|Participant Flow|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
10883350|NCT00475878|FG001|Participant Flow|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
10883351|NCT00475878|OG000|Outcome|10 mg Escitalopram|in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction
10883352|NCT00475878|OG001|Outcome|Placebo|in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction
10883353|NCT00475878|OG000|Outcome|10 mg Escitalopram|individuals were given 10mg escitalopram prior to buprenorphine induction
10883354|NCT00475878|OG001|Outcome|Placebo|individuals were given a placebo study medication prior to buprenorphine induction
10883355|NCT00475878|EG000|Reported Event|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
10883356|NCT00475878|EG001|Reported Event|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
10883357|NCT00475904|BG000|Baseline|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
10883358|NCT00475904|BG001|Baseline|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
10883359|NCT00475904|BG002|Baseline|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
10883360|NCT00475904|BG003|Baseline|Total|Total of all reporting groups
10883361|NCT00475904|FG000|Participant Flow|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
10883362|NCT00475904|FG001|Participant Flow|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
11341223|NCT03678870|OG001|Outcome|Control|Standard discharge instructions, which lists medications prescribed at discharge
10883363|NCT00475904|FG002|Participant Flow|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
10883364|NCT00475904|OG000|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
10883365|NCT00475904|OG001|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
10883366|NCT00475904|OG002|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
10883367|NCT00475904|EG000|Reported Event|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
10883368|NCT00475904|EG001|Reported Event|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
10883369|NCT00475904|EG002|Reported Event|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
10883370|NCT00475982|BG000|Baseline|Arm 1: Weight Loss|"Weight Loss Group~Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics."
10883371|NCT00475982|BG001|Baseline|Arm 2: No Weight Loss|"No Weight Loss Group~No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy."
10883372|NCT00475982|BG002|Baseline|Total|Total of all reporting groups
10883373|NCT00475982|FG000|Participant Flow|Arm 1: Weight Loss|"Weight Loss Group~Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics."
10883374|NCT00475982|FG001|Participant Flow|Arm 2: No Weight Loss|"No Weight Loss Group~No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy."
10883375|NCT00475982|OG000|Outcome|Arm 1: Weight Loss|"Weight Loss Group~Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics."
10883376|NCT00475982|OG001|Outcome|Arm 2: No Weight Loss|"No Weight Loss Group~No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy."
10883377|NCT00475982|EG000|Reported Event|Arm 1: Weight Loss|"Weight Loss Group~Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics."
10883378|NCT00475982|EG001|Reported Event|Arm 2: No Weight Loss|"No Weight Loss Group~No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy."
10887160|NCT00499109|FG000|Participant Flow|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
10887161|NCT00499109|FG001|Participant Flow|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
10887162|NCT00499109|OG000|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
10887163|NCT00499109|OG001|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
10887164|NCT00499109|EG000|Reported Event|Experimental: E1|Docetaxel/Vinorelbine
10887165|NCT00499109|EG001|Reported Event|Experimental: E2|Docetaxel/Carboplatin
10887166|NCT00499109|EG002|Reported Event|Experimental: E3|Gemcitabine/Docetaxel
10887167|NCT00499109|EG003|Reported Event|Experimental: E4|Gemcitabine/Carboplatin
10887168|NCT00499109|EG004|Reported Event|Control: C|Gemcitabine/Carboplatin
10887169|NCT00499122|BG000|Baseline|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
10887170|NCT00499122|FG000|Participant Flow|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
10887171|NCT00499122|OG000|Outcome|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
11009877|NCT01104545|OG001|Outcome|0.25 mg Twice a Day (b.i.d.) MK-3614|Participants received single daily dose of 0.25 mg MK-3614 b.i.d.
10883379|NCT00476008|BG000|Baseline|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
10883380|NCT00476008|BG001|Baseline|Placebo|Placebo : Placebo BID for 12 months
10883381|NCT00476008|BG002|Baseline|Total|Total of all reporting groups
10883382|NCT00476008|FG000|Participant Flow|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
10883383|NCT00476008|FG001|Participant Flow|Placebo|Placebo : Placebo BID for 12 months
10883384|NCT00476008|OG000|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
10883385|NCT00476008|OG001|Outcome|Placebo|Placebo : Placebo BID for 12 months
10883386|NCT00476008|OG000|Outcome|Placebo|Placebo : Placebo BID for 12 months
10883387|NCT00476008|OG001|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
10883388|NCT00476008|OG000|Outcome|Placebo|Placebo: One tablet placebo morning and evening (BID) for 12 months
10883389|NCT00476008|OG001|Outcome|Memantine|Memantine: One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
10883390|NCT00476008|EG000|Reported Event|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
10883391|NCT00476008|EG001|Reported Event|Placebo|Placebo : Placebo BID for 12 months
10883392|NCT00476021|BG000|Baseline|Immediate Postplacental IUD Insertion|"immediate postplacental IUD insertion~Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
10883393|NCT00476021|BG001|Baseline|Delayed IUD Insertion (6-8 Weeks After Delivery)|"delayed IUD insertion (6-8 weeks after delivery)~Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
10883394|NCT00476021|BG002|Baseline|Total|Total of all reporting groups
10883395|NCT00476021|FG000|Participant Flow|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
10883396|NCT00476021|FG001|Participant Flow|Delayed IUD Insertion|Delayed LNG-IUD insertion
10883397|NCT00476021|OG000|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
10883398|NCT00476021|OG001|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
10883399|NCT00476021|OG000|Outcome|Received Postplacental IUD|Received postplacental LNG-IUD
10883400|NCT00476021|OG000|Outcome|Delayed IUD Insertion|Followed up for delayed IUD insertion
10883401|NCT00476021|OG000|Outcome|Postplacental IUD Insertion|Infection after postplacental LNG-IUD insertion
10883402|NCT00476021|OG001|Outcome|Delayed IUD Insertion|Infection after delayed LNG-IUD insertion
10883403|NCT00476021|OG000|Outcome|Pregnancy Within 6 Months for Ineligible Participants|If a participant was found to be ineligible as a result of postenrollment criteria, she was instructed to follow up with her primary obstetrician or midwife for postpartum contraception and delayed IUD insertion
10883404|NCT00476021|OG001|Outcome|Follow-up for IUD Insertion for Ineligible Participants|Ineligible participants were followed for 6 months to evaluate whether they received an IUD from their ob/gyn
10883405|NCT00476021|EG000|Reported Event|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
10883406|NCT00476021|EG001|Reported Event|Delayed IUD Insertion|Delayed LNG-IUD insertion
10883407|NCT00476047|BG000|Baseline|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
10883408|NCT00476047|FG000|Participant Flow|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
10883409|NCT00476047|OG000|Outcome|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
10883410|NCT00476047|OG000|Outcome|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV"
10883411|NCT00476047|OG000|Outcome|Patient Who Achieved CR After Any Prior Therapy|Patients who received study treatment and who had achieved a complete remission (CR) after any prior therapy.
10883412|NCT00476047|EG000|Reported Event|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
10883413|NCT00476086|BG000|Baseline|Oxaliplatin/ Gemcitabine Then Radiation|"Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.~on"
10883414|NCT00476086|FG000|Participant Flow|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
10883415|NCT00476086|OG000|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
10883416|NCT00476086|OG000|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
10883417|NCT00476086|EG000|Reported Event|Oxaliplatin/ Gemcitabine|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.
10883418|NCT00476086|EG001|Reported Event|Radiation|On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
10883419|NCT00476151|BG000|Baseline|Placebo Cream|vehicle cream applied twice daily for 4 weeks
10883420|NCT00476151|BG001|Baseline|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
10883421|NCT00476151|BG002|Baseline|Total|Total of all reporting groups
11225375|NCT02367781|OG001|Outcome|Arm B (Nab-Paclitaxel+Carboplatin Crossover)|Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
11225376|NCT02367781|EG000|Reported Event|Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)|Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
11225377|NCT02367781|EG001|Reported Event|Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin)|Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who did not crossover to receive atezolizumab as monotherapy.
11225378|NCT02367781|EG002|Reported Event|Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)|Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who crossed over to receive atezolizumab as monotherapy.
11225379|NCT02367820|BG000|Baseline|Rollover NKTR-181|Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study
11225380|NCT02367820|BG001|Baseline|Rollover PBO|Subjects administered placebo in preceding phase 3 efficacy/safety study
11225381|NCT02367820|BG002|Baseline|De Novo Naive|Newly enrolled opioid naïve subjects
10883422|NCT00476151|FG000|Participant Flow|Placebo Cream|vehicle cream applied twice daily for 4 weeks
10883423|NCT00476151|FG001|Participant Flow|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
11225382|NCT02367820|BG003|Baseline|De Novo Opioid Experienced|Newly enrolled opioid experienced subjects
10883424|NCT00476151|OG000|Outcome|Placebo Cream|vehicle cream applied twice daily for 4 weeks
10883425|NCT00476151|OG001|Outcome|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
10883426|NCT00476151|EG000|Reported Event|Placebo Cream|vehicle cream applied twice daily for 4 weeks
10883427|NCT00476151|EG001|Reported Event|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
10883428|NCT00476229|BG000|Baseline|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
10883429|NCT00476229|FG000|Participant Flow|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
10883430|NCT00476229|OG000|Outcome|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
10883431|NCT00476229|EG000|Reported Event|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
11225383|NCT02367820|BG004|Baseline|Total|Total of all reporting groups
11225384|NCT02367820|FG000|Participant Flow|NKTR-181|NKTR-181 tablets at 100-600 mg orally twice daily
11225385|NCT02367820|OG000|Outcome|Rollover NKTR-181|Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study
11225386|NCT02367820|OG001|Outcome|Rollover PBO|Subjects administered placebo in preceding phase 3 efficacy/safety study
11225387|NCT02367820|OG002|Outcome|De Novo Opioid Experienced|Newly enrolled opioid experienced subjects
11225388|NCT02367820|OG003|Outcome|De Novo Naive|Newly enrolled opioid naïve subjects
11225389|NCT02367820|EG000|Reported Event|Rollover NKTR-181|Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study
11225390|NCT02367820|EG001|Reported Event|Rollover PBO|Subjects administered placebo in preceding phase 3 efficacy/safety study
11225391|NCT02367820|EG002|Reported Event|De Novo Opioid Experienced|Newly enrolled opioid experienced subjects
11225392|NCT02367820|EG003|Reported Event|De Novo Naive|Newly enrolled opioid naïve subjects
11225393|NCT02367833|BG000|Baseline|Control Group|The Control group will complete all procedures with the exception of contraceptive therapy.
11341224|NCT03678870|EG000|Reported Event|Education|"Opioid Education~Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge."
11341225|NCT03678870|EG001|Reported Event|Control|Standard discharge instructions, which lists medications prescribed at discharge
10883432|NCT00476242|BG000|Baseline|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
10883433|NCT00476242|BG001|Baseline|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
10883434|NCT00476242|BG002|Baseline|Total|Total of all reporting groups
10883435|NCT00476242|FG000|Participant Flow|Placebo and Vivitrol|Participants treated with placebo capsules and Vivitrol.
10883436|NCT00476242|FG001|Participant Flow|Memantine and Vivitrol|Participants treated with memantine 40 mg/d capsules and Vivitrol.
10883437|NCT00476242|OG000|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
10883438|NCT00476242|OG001|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
10883439|NCT00476242|OG000|Outcome|Placebo and Vivitrol|Participants treated with placebo capsules and Vivitrol.
10883440|NCT00476242|OG001|Outcome|Memantine and Vivitrol|Participants treated with memantine 40 mg/d capsules and Vivitrol.
10883441|NCT00476242|EG000|Reported Event|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
10883442|NCT00476242|EG001|Reported Event|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
10883443|NCT00476476|BG000|Baseline|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
10883444|NCT00476476|BG001|Baseline|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
10883445|NCT00476476|BG002|Baseline|Total|Total of all reporting groups
10883446|NCT00476476|FG000|Participant Flow|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
10883447|NCT00476476|FG001|Participant Flow|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
10883448|NCT00476476|OG000|Outcome|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
10883449|NCT00476476|OG001|Outcome|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
10883450|NCT00476476|EG000|Reported Event|Erlotinib|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
10883451|NCT00476593|BG000|Baseline|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
10883452|NCT00476593|BG001|Baseline|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
10883453|NCT00476593|BG002|Baseline|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
10883454|NCT00476593|BG003|Baseline|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
10883455|NCT00476593|BG004|Baseline|Total|Total of all reporting groups
10883456|NCT00476593|FG000|Participant Flow|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
10883457|NCT00476593|FG001|Participant Flow|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
10883458|NCT00476593|FG002|Participant Flow|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
11009878|NCT01104545|OG002|Outcome|0.25 mg t.i.d MK-3614|Participants received single daily oral dose of 0.25 mg MK-3614 t.i.d.
10883459|NCT00476593|FG003|Participant Flow|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
10883460|NCT00476593|OG000|Outcome|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
10883461|NCT00476593|OG001|Outcome|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
10883462|NCT00476593|OG002|Outcome|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
10883463|NCT00476593|OG003|Outcome|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
10883464|NCT00476593|EG000|Reported Event|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
10883465|NCT00476593|EG001|Reported Event|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
10883466|NCT00476593|EG002|Reported Event|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
10883467|NCT00476593|EG003|Reported Event|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
10883468|NCT00476645|BG000|Baseline|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
10883469|NCT00476645|FG000|Participant Flow|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
10883470|NCT00476645|OG000|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
10883471|NCT00476645|EG000|Reported Event|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
10883472|NCT00476788|BG000|Baseline|Omnipod Device|Patients will be placed on an Omnipod insulin pump
11147163|NCT01856543|EG001|Reported Event|Mometasone Furoate 0.1%|"Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.~Mometasone F"
10883473|NCT00476788|FG000|Participant Flow|Omnipod Device|Patients will be placed on an Omnipod insulin pump
10883474|NCT00476788|OG000|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
11147164|NCT01856569|BG000|Baseline|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician's discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
10883475|NCT00476788|EG000|Reported Event|Omnipod Device|Patients will be placed on an Omnipod insulin pump
10883476|NCT00476957|BG000|Baseline|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
10883477|NCT00476957|BG001|Baseline|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
10883478|NCT00476957|BG002|Baseline|Total|Total of all reporting groups
10883479|NCT00476957|FG000|Participant Flow|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
10883480|NCT00476957|FG001|Participant Flow|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
10883481|NCT00476957|OG000|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
10883482|NCT00476957|OG001|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
10883483|NCT00476957|EG000|Reported Event|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
10883484|NCT00476957|EG001|Reported Event|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
10883485|NCT00476996|BG000|Baseline|Placebo x 2 IV + Non-Biologic DMARD|Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883486|NCT00476996|BG001|Baseline|Ocrelizumab 200 mg x 2 + Non-Biologic DMARD|Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883487|NCT00476996|BG002|Baseline|Ocrelizumab 500 mg x 2 + Non-Biologic DMARD|Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883488|NCT00476996|BG003|Baseline|Total|Total of all reporting groups
10883489|NCT00476996|FG000|Participant Flow|Placebo x 2 IV + Non-Biologic DMARD|Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
11009879|NCT01104545|OG003|Outcome|0.5 mg MK-3614|Participants received a single oral dose of 0.50 mg MK-3614 after an 8-hour fast
10883490|NCT00476996|FG001|Participant Flow|Ocrelizumab 200 mg x 2 + Non-Biologic DMARD|Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883491|NCT00476996|FG002|Participant Flow|Ocrelizumab 500 mg x 2 + Non-Biologic DMARD|Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883492|NCT00476996|FG003|Participant Flow|Ocrelizumab 500 mg x 2 IV + Non-biologic DMARD (OLE)|At the discretion of the investigator, eligible participants received 500 mg Ocrelizumab IV in two infusions separated by 14 days
11147165|NCT01856569|FG000|Participant Flow|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician's discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
11147166|NCT01856569|OG000|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician's discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
11147167|NCT01856569|EG000|Reported Event|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician's discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
11147168|NCT01856582|BG000|Baseline|CD34+ Selected Stem Cell Infusion|"An infusion of selected CD34+ stem cells will be given without any preparative regimen.~CD34+: CD34+ cells are selected using the CliniMACS System; without preparative regimen"
11147169|NCT01856582|FG000|Participant Flow|CD34+ Selected Stem Cell Infusion|A single infusion of selected CD34+ stem cells will be given without any preparative regimen. Stem cells will be depleted of T-cells using a CliniMACS CD34+ cell selection device and infused into the patient with a maximum T-cell dose of 5 x 10^4/kg. The minimum number of CD34+ cells that will be infused is 1x10^6/kg.
11147170|NCT01856582|OG000|Outcome|CD34+ Selected Stem Cell Infusion|"An infusion of selected CD34+ stem cells will be given without any preparative regimen.~CD34+: CD34+ cells are selected using the CliniMACS System; without preparative regimen"
11147171|NCT01856582|EG000|Reported Event|CD34+ Selected Stem Cell Infusion|"An infusion of selected CD34+ stem cells will be given without any preparative regimen.~CD34+: CD34+ cells are selected using the CliniMACS System; without preparative regimen"
11147172|NCT01856595|BG000|Baseline|Part A: Placebo|Participants received placebo matched to PF-06291874 orally once daily for 14 or 28 days
11147173|NCT01856595|BG001|Baseline|Part A: PF-06291874 5 mg|Participants received PF-06291874 5 milligram (mg) orally once daily for 14 days
11147174|NCT01856595|BG002|Baseline|Part A: PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
11147175|NCT01856595|BG003|Baseline|Part A: PF-06291874 50 mg|Participants received PF-06291874 50 mg orally once daily for 14 days
11147176|NCT01856595|BG004|Baseline|Part A: PF-06291874 100 mg|Participants received PF-06291874 100 mg orally once daily for 28 days
10883493|NCT00476996|OG000|Outcome|Placebo x 2 IV + Non-Biologic DMARD|Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883494|NCT00476996|OG001|Outcome|Ocrelizumab 200 mg x 2 + Non-Biologic DMARD|Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
11147177|NCT01856595|BG005|Baseline|Part A: PF-06291874 150 mg|Participants received PF-06291874 150 mg orally once daily for 14 days
11147178|NCT01856595|BG006|Baseline|Part B: Placebo|Participants received placebo matched to PF-06291874 orally once daily for 14 or 28 days
11147179|NCT01856595|BG007|Baseline|Part B: PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
11147180|NCT01856595|BG008|Baseline|Part B: PF-06291874 30 mg|Participants received PF-06291874 30 mg orally once daily for 28 days
11147181|NCT01856595|BG009|Baseline|Total|Total of all reporting groups
11147182|NCT01856595|FG000|Participant Flow|Part A: Placebo|Participants received placebo matched to PF-06291874 orally once daily for 14 or 28 days
11147183|NCT01856595|FG001|Participant Flow|Part A: PF-06291874 5 mg|Participants received PF-06291874 5 milligram (mg) orally once daily for 14 days
11147184|NCT01856595|FG002|Participant Flow|Part A: PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
11147185|NCT01856595|FG003|Participant Flow|Part A: PF-06291874 50 mg|Participants received PF-06291874 50 mg orally once daily for 14 days
11147186|NCT01856595|FG004|Participant Flow|Part A: PF-06291874 100 mg|Participants received PF-06291874 100 mg orally once daily for 28 days
11147187|NCT01856595|FG005|Participant Flow|Part A: PF-06291874 150 mg|Participants received PF-06291874 150 mg orally once daily for 14 days
11147188|NCT01856595|FG006|Participant Flow|Part B: Placebo|Participants received placebo matched to PF-06291874 orally once daily for 14 or 28 days
11147189|NCT01856595|FG007|Participant Flow|Part B: PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
11147190|NCT01856595|FG008|Participant Flow|Part B: PF-06291874 30 mg|Participants received PF-06291874 30 mg orally once daily for 28 days
11147191|NCT01856595|OG000|Outcome|Placebo|Participants received placebo orally once daily for 14 or 28 days
11147192|NCT01856595|OG001|Outcome|PF-06291874 5 mg|Participants received PF-06291874 5 mg orally once daily for 14 days
11147193|NCT01856595|OG002|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
10883495|NCT00476996|OG002|Outcome|Ocrelizumab 500 mg x 2 + Non-Biologic DMARD|Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883496|NCT00476996|EG000|Reported Event|Placebo x 2 IV + Non-Biologic DMARD|Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
11009880|NCT01104545|OG004|Outcome|0.75 mg MK-3614|Participants received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
10883497|NCT00476996|EG001|Reported Event|Ocrelizumab 200 mg x 2 + Non-Biologic DMARD|Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883498|NCT00476996|EG002|Reported Event|Ocrelizumab 500 mg x 2 + Non-Biologic DMARD|Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
10883499|NCT00476996|EG003|Reported Event|Ocrelizumab 500 mg x 2 IV + Non-biologic DMARD (OLE)|At the discretion of the investigator, eligible participants received 500 mg Ocrelizumab IV in two infusions separated by 14 days
10883500|NCT00477087|BG000|Baseline|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
10883501|NCT00477087|FG000|Participant Flow|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
10883502|NCT00477087|OG000|Outcome|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
10883503|NCT00477087|EG000|Reported Event|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
10883504|NCT00477152|BG000|Baseline|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
10883505|NCT00477152|FG000|Participant Flow|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
10883506|NCT00477152|OG000|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
11147194|NCT01856595|OG003|Outcome|PF-06291874 50 mg|Participants received PF-06291874 50 mg orally once daily for 14 days
10883507|NCT00477152|EG000|Reported Event|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
10883508|NCT00477165|BG000|Baseline|Cialopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
10883509|NCT00477165|BG001|Baseline|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
10883510|NCT00477165|BG002|Baseline|Total|Total of all reporting groups
10883511|NCT00477165|FG000|Participant Flow|Cialopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
10883512|NCT00477165|FG001|Participant Flow|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
10883513|NCT00477165|OG000|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
10883514|NCT00477165|OG001|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
10883515|NCT00477165|EG000|Reported Event|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
10883516|NCT00477165|EG001|Reported Event|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
10883517|NCT00477191|BG000|Baseline|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and then 50 mg once a week for 3 months."
10883518|NCT00477191|FG000|Participant Flow|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
10883519|NCT00477191|OG000|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
10883520|NCT00477191|EG000|Reported Event|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
10883521|NCT00477204|BG000|Baseline|Vytorin|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
10883522|NCT00477204|BG001|Baseline|Zocor|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
10883523|NCT00477204|BG002|Baseline|Total|Total of all reporting groups
10883524|NCT00477204|FG000|Participant Flow|Ezetimibe/Simvastatin|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
10883525|NCT00477204|FG001|Participant Flow|Simvastatin|"simvastatin: simvastatin 20 mg daily~placebo for each medication"
10883526|NCT00477204|OG000|Outcome|Vytorin (Ezetimibe/Simvastatin)|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
10883527|NCT00477204|OG001|Outcome|Zocor (Simvastatin)|"simvastatin: simvastatin 20 mg daily~placebo for each medication"
10883528|NCT00477204|EG000|Reported Event|Vytorin (Simvastatin + Ezetimibe)|Vytorin [simvastatin + ezetimibe]20 mg taken daily for 6 months to compare in a 2- arm design to Zocor [simvastatin] .
10883529|NCT00477204|EG001|Reported Event|Zocor [Simvastatin]|Zocor [simvastatin] 20 mg taken daily for 6 months to compare in a 2- arm design to Vytorin [simvastatin + ezetimibe].
10883530|NCT00477269|BG000|Baseline|STI571|STI571
10883531|NCT00477269|BG001|Baseline|Placebo|Placebo
10883532|NCT00477269|BG002|Baseline|Total|Total of all reporting groups
10883533|NCT00477269|FG000|Participant Flow|STI571|STI571
10883534|NCT00477269|FG001|Participant Flow|Placebo|Placebo
10883535|NCT00477269|FG002|Participant Flow|All Patients|Open label extension
10883536|NCT00477269|OG000|Outcome|STI571|STI571
10883537|NCT00477269|OG001|Outcome|Placebo|Placebo
10883538|NCT00477269|OG000|Outcome|All Patients|Open label extension
10883539|NCT00477269|EG000|Reported Event|Core - STI571|Core - STI571
11147195|NCT01856595|OG004|Outcome|PF-06291874 100 mg|Participants received PF-06291874 100 mg orally once daily for 28 days
11147196|NCT01856595|OG005|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg orally once daily for 14 days
11147197|NCT01856595|OG001|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
11147198|NCT01856595|OG002|Outcome|PF-06291874 30 mg|Participants received PF-06291874 30 mg orally once daily for 28 days
11147199|NCT01856595|OG000|Outcome|PF-06291874 5 mg|Participants received PF-06291874 5 mg orally once daily for 14 days
11147200|NCT01856595|OG001|Outcome|PF-06291874 30 mg|Participants received PF-06291874 30 mg orally once daily for 28 days
11147201|NCT01856595|OG002|Outcome|Placebo|Participants received placebo orally once daily for 14 or 28 days
11147202|NCT01856595|OG002|Outcome|PF-06291874 50 mg|Participants received PF-06291874 50 mg orally once daily for 14 days
11147203|NCT01856595|OG003|Outcome|PF-06291874 100 mg|Participants received PF-06291874 100 mg orally once daily for 28 days
11147204|NCT01856595|OG004|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg orally once daily for 14 days
11147205|NCT01856595|OG000|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
11147206|NCT01856595|OG003|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg orally once daily for 14 days
11147207|NCT01856595|OG004|Outcome|PF-06291874 15 mg - Part B|Participants received PF-06291874 15 mg orally once daily for 14 days
11147208|NCT01856595|OG000|Outcome|PF-06291874 50 mg|Participants received PF-06291874 50 mg orally once daily for 14 days
11147209|NCT01856595|OG001|Outcome|PF-06291874 100 mg|Participants received PF-06291874 100 mg orally once daily for 28 days
11147210|NCT01856595|OG002|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg orally once daily for 14 days
11147211|NCT01856595|OG002|Outcome|Placebo - Part B|Participants received placebo orally once daily for 14 or 28 days
11147212|NCT01856595|OG003|Outcome|PF-06291874 30 mg - Part B|Participants received PF-06291874 30 mg orally once daily for 14 days
11147213|NCT01856595|OG003|Outcome|PF-06291874 30 mg|Participants received PF-06291874 30 mg orally once daily for 28 days
11147214|NCT01856595|EG000|Reported Event|Part A: Placebo|Participants received placebo matched to PF-06291874 orally once daily for 14 or 28 days
11147215|NCT01856595|EG001|Reported Event|Part A: PF-06291874 5 mg|Participants received PF-06291874 5 milligram (mg) orally once daily for 14 days
11147216|NCT01856595|EG002|Reported Event|Part A: PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
11147217|NCT01856595|EG003|Reported Event|Part A: PF-06291874 50 mg|Participants received PF-06291874 50 mg orally once daily for 14 days
11147218|NCT01856595|EG004|Reported Event|Part A: PF-06291874 100 mg|Participants received PF-06291874 100 mg orally once daily for 28 days
11147219|NCT01856595|EG005|Reported Event|Part A: PF-06291874 150 mg|Participants received PF-06291874 150 mg orally once daily for 14 days
11147220|NCT01856595|EG006|Reported Event|Part B: Placebo|Participants received placebo matched to PF-06291874 orally once daily for 14 or 28 days
11147221|NCT01856595|EG007|Reported Event|Part B: PF-06291874 15 mg|Participants received PF-06291874 15 mg orally once daily for 14 days
11147222|NCT01856595|EG008|Reported Event|Part B: PF-06291874 30 mg|Participants received PF-06291874 30 mg orally once daily for 28 days
11147223|NCT01856595|EG009|Reported Event|Total|
11147224|NCT01856673|BG000|Baseline|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
11147225|NCT01856673|BG001|Baseline|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
10883540|NCT00477269|EG001|Reported Event|Core - Placebo|Core - Placebo
10883541|NCT00477269|EG002|Reported Event|Extension - STI571|Extension - STI571
11009881|NCT01104545|OG005|Outcome|1.25 mg MK-3614|Participants received a single daily dose of 1.25 mg MK-3614
11147226|NCT01856673|BG002|Baseline|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
11147227|NCT01856673|BG003|Baseline|Total|Total of all reporting groups
11147228|NCT01856673|FG000|Participant Flow|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
11147229|NCT01856673|FG001|Participant Flow|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
11147230|NCT01856673|FG002|Participant Flow|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
11147231|NCT01856673|OG000|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
11147232|NCT01856673|OG001|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
11147233|NCT01856673|OG002|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
11147234|NCT01856673|EG000|Reported Event|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
11341226|NCT03679494|BG000|Baseline|SDM Intervention Group|"Using shared decision making support tool for intervention~Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions"
11341227|NCT03679494|BG001|Baseline|Usual Care Group|No intervention, just continue using usual care
10850970|NCT03410992|EG007|Reported Event|Bimekizumab 320 mg Q4W Escape (ESS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
11341228|NCT03679494|BG002|Baseline|Total|Total of all reporting groups
11341229|NCT03679494|FG000|Participant Flow|SDM Intervention Group|"Using shared decision making support tool for intervention~Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions"
11147235|NCT01856673|EG001|Reported Event|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
11147236|NCT01856673|EG002|Reported Event|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
11147237|NCT01856686|BG000|Baseline|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
11147238|NCT01856686|BG001|Baseline|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
11147239|NCT01856686|BG002|Baseline|Total|Total of all reporting groups
11147240|NCT01856686|FG000|Participant Flow|BP22042013|This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
11147241|NCT01856686|FG001|Participant Flow|Low Carbohydrate Diet|This group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
11147242|NCT01856686|OG000|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
11147243|NCT01856686|OG001|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
11147244|NCT01856686|EG000|Reported Event|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
11147245|NCT01856686|EG001|Reported Event|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
11009882|NCT01104545|OG006|Outcome|Placebo|Participants received a single oral dose of placebo for MK-3614 after an 8-hour fast
11009883|NCT01104545|OG000|Outcome|0.5 mg MK-3614 Panel C|Participants received a single oral dose of 0.50 mg MK-3614 after an 8-hour fast
11147246|NCT01856712|BG000|Baseline|Oral Naltrexone|"an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence."
11147247|NCT01856712|BG001|Baseline|Injectable Naltrexone|"a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later.~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence."
11147248|NCT01856712|BG002|Baseline|Total|Total of all reporting groups
11147249|NCT01856712|FG000|Participant Flow|Oral Naltrexone|"an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence."
11147250|NCT01856712|FG001|Participant Flow|Injectable Naltrexone|"a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later.~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence."
11147251|NCT01856712|OG000|Outcome|Oral Naltrexone|enrolled and received oral naltrexone
11147252|NCT01856712|OG001|Outcome|Injectable Naltrexone|enrolled and received injectable naltrexone
11147253|NCT01856712|OG000|Outcome|Oral Naltrexone|"an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.~Among those who were randomized (n=54), 64.8% (n=35) received a study medication and completed all follow-ups. Among those received a study medication and were proactively followed (n=45), 77% completed all follow-ups."
11341230|NCT03679494|FG001|Participant Flow|Usual Care Group|No intervention, just continue using usual care
11147254|NCT01856712|OG001|Outcome|Injectable Naltrexone|"a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later.~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.~Among those who were randomized (n=54), 64.8% (n=35) received a study medication and completed all follow-ups. Among those received a study medication and were proactively followed (n=45), 77% completed all follow-ups."
11147255|NCT01856712|OG000|Outcome|Oral Naltrexone|"an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.~Among those who were randomized (n=54), 64.8% (n=35) received a study medication and completed all follow-ups. Among those received a study medication and were proactively followed (n=45), 77% completed all follow-ups. 62% of injection group and 61% of oral group met study definition of adherence"
11147256|NCT01856712|OG001|Outcome|Injectable Naltrexone|"a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later.~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.~Among those who were randomized (n=54), 64.8% (n=35) received a study medication and completed all follow-ups. Among those received a study medication and were proactively followed (n=45), 77% completed all follow-ups. 62% of injection group and 61% of oral group met study definition of adherence"
11147257|NCT01856712|EG000|Reported Event|Oral Naltrexone|"an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence."
11147258|NCT01856712|EG001|Reported Event|Injectable Naltrexone|"a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later.~Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence."
11147259|NCT01856764|BG000|Baseline|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
11147260|NCT01856764|BG001|Baseline|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
11147261|NCT01856764|BG002|Baseline|Total|Total of all reporting groups
11147262|NCT01856764|FG000|Participant Flow|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
11147263|NCT01856764|FG001|Participant Flow|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
11009884|NCT01104545|OG001|Outcome|0.75 mg MK-3614 Panel C|Participants received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
11147264|NCT01856764|OG000|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
11147265|NCT01856764|OG001|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
11147266|NCT01856764|EG000|Reported Event|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
11147267|NCT01856764|EG001|Reported Event|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
11147268|NCT01856790|BG000|Baseline|Baseline Subject Characteristics|"Each participant recruited into the study will undergo two inpatient closed loop admissions.~The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.~Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.~Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."
11147269|NCT01856790|FG000|Participant Flow|All Study Participants|"Each participant recruited into the study will undergo two inpatient closed loop admissions.~The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.~Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.~Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."
11147270|NCT01856790|OG000|Outcome|Closed Loop Insulin Delivery|"Each participant recruited into the study will undergo two inpatient closed loop admissions.~The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback."
11147271|NCT01856790|OG001|Outcome|Closed Loop + Liraglutide|"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.~Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."
11147272|NCT01856790|OG000|Outcome|Closed Loop Insulin Delivery|"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.~Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."
11147273|NCT01856790|OG000|Outcome|ePID Closed Loop System Without Liraglutide|"ePID closed loop system alone~ePID closed loop system: Insulin pump controlled by closed loop unit and algorithm"
11147274|NCT01856790|OG001|Outcome|ePID Closed Loop System With Liraglutide|"liraglutide + ePID closed loop system~ePID closed loop system: Insulin pump controlled by closed loop unit and algorithm~liraglutide: Liraglutide is a long-acting analog of human glucagon-like peptide 1 (GLP-1) that works as a GLP-1 receptor agonist"
11147275|NCT01856790|OG000|Outcome|Pre-Liraglutide Treatment|Baseline characteristics prior to liraglutide therapy
11147276|NCT01856790|OG001|Outcome|Post-Liraglutide Treatment|Characteristics following 3 week outpatient dose titration phase of liraglutide
11147277|NCT01856790|EG000|Reported Event|Closed Loop Only|"Each participant recruited into the study will undergo two inpatient closed loop admissions.~The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback"
11147278|NCT01856790|EG001|Reported Event|Closed Loop + Liraglutide|"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.~Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."
11147279|NCT01856907|BG000|Baseline|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
10883542|NCT00477295|BG000|Baseline|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10883543|NCT00477295|BG001|Baseline|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10883544|NCT00477295|BG002|Baseline|Total|Total of all reporting groups
10883545|NCT00477295|FG000|Participant Flow|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10883546|NCT00477295|FG001|Participant Flow|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10883547|NCT00477295|OG000|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
11147280|NCT01856907|BG001|Baseline|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
11147281|NCT01856907|BG002|Baseline|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
11147282|NCT01856907|BG003|Baseline|Total|Total of all reporting groups
11147283|NCT01856907|FG000|Participant Flow|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
11147284|NCT01856907|FG001|Participant Flow|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
11147285|NCT01856907|FG002|Participant Flow|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
11147286|NCT01856907|OG000|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg twice a day (BID)~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
10883548|NCT00477295|OG001|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
11009885|NCT01104545|OG000|Outcome|0.5 mg MK-3614 Panel C|Participants received a single oral dose of 0.5 mg MK-3614 after an 8-hour fast
11147287|NCT01856907|OG001|Outcome|Placebo Pill|"1 pill/ twice a day (BID) for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
11147288|NCT01856907|OG002|Outcome|Metformin|"1000 mg twice a day (BID)~Metformin: Biguanide- insulin sensitizer"
11147289|NCT01856907|OG000|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
11147290|NCT01856907|OG001|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
11147291|NCT01856907|OG002|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
11147292|NCT01856907|EG000|Reported Event|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
10883549|NCT00477295|OG000|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10883550|NCT00477295|OG000|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.~During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
10883551|NCT00477295|EG000|Reported Event|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10883552|NCT00477295|EG001|Reported Event|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10883553|NCT00477334|BG000|Baseline|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
10883554|NCT00477334|BG001|Baseline|Placebo Comparator|Placebo twice a day for one day for treatment.
10883555|NCT00477334|BG002|Baseline|Total|Total of all reporting groups
10883556|NCT00477334|FG000|Participant Flow|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
10883557|NCT00477334|FG001|Participant Flow|Placebo Comparator|Placebo twice a day for one day for treatment.
10883558|NCT00477334|OG000|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
10883559|NCT00477334|OG001|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
10883560|NCT00477334|OG000|Outcome|Grade 1 Toxicity|
10883561|NCT00477334|OG001|Outcome|Grade 2 Toxicity|
10883562|NCT00477334|OG002|Outcome|Grade 3 Toxicity|
10883563|NCT00477334|OG003|Outcome|Grade 4 Toxicity|
10883564|NCT00477334|EG000|Reported Event|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
10883565|NCT00477334|EG001|Reported Event|Placebo Comparator|Placebo twice a day for one day for treatment.
10883566|NCT00477386|BG000|Baseline|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
10883567|NCT00477386|BG001|Baseline|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
10883568|NCT00477386|BG002|Baseline|Total|Total of all reporting groups
10883569|NCT00477386|FG000|Participant Flow|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
10883570|NCT00477386|FG001|Participant Flow|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
10883571|NCT00477386|OG000|Outcome|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
11009886|NCT01104545|OG000|Outcome|0.5 mg MK-3614 Panel C|Participant received single oral dose of 0.5 mg of MK-3614 after an 8 -hour fast
10883572|NCT00477386|OG000|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
10883573|NCT00477386|EG000|Reported Event|Phase I Dosing Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
10883574|NCT00477386|EG001|Reported Event|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
11147293|NCT01856907|EG001|Reported Event|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
10883575|NCT00477451|BG000|Baseline|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883576|NCT00477451|BG001|Baseline|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883577|NCT00477451|BG002|Baseline|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
11009887|NCT01104545|OG001|Outcome|0.25 mg w/ Food MK-3614 Panel A|Participants received a single oral dose of 0.25 mg MK-3614 after ingesting a high-fat breakfest
11147294|NCT01856907|EG002|Reported Event|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
10883578|NCT00477451|BG003|Baseline|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883579|NCT00477451|BG004|Baseline|Total|Total of all reporting groups
10883580|NCT00477451|FG000|Participant Flow|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883581|NCT00477451|FG001|Participant Flow|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883582|NCT00477451|FG002|Participant Flow|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883583|NCT00477451|FG003|Participant Flow|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883584|NCT00477451|OG000|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883585|NCT00477451|OG001|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883586|NCT00477451|EG000|Reported Event|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883587|NCT00477451|EG001|Reported Event|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883588|NCT00477451|EG002|Reported Event|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883589|NCT00477451|EG003|Reported Event|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
10883590|NCT00477464|BG000|Baseline|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
10883591|NCT00477464|FG000|Participant Flow|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
10883592|NCT00477464|OG000|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
10883593|NCT00477464|OG000|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
10883594|NCT00477464|OG000|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|
10883595|NCT00477464|EG000|Reported Event|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
10883596|NCT00477490|BG000|Baseline|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
10883597|NCT00477490|BG001|Baseline|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883598|NCT00477490|BG002|Baseline|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883599|NCT00477490|BG003|Baseline|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883600|NCT00477490|BG004|Baseline|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883601|NCT00477490|BG005|Baseline|Total|Total of all reporting groups
10883602|NCT00477490|FG000|Participant Flow|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883603|NCT00477490|FG001|Participant Flow|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883604|NCT00477490|FG002|Participant Flow|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883605|NCT00477490|FG003|Participant Flow|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883606|NCT00477490|FG004|Participant Flow|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883607|NCT00477490|FG005|Participant Flow|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
10883608|NCT00477490|FG006|Participant Flow|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
11147295|NCT01856933|BG000|Baseline|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
11147296|NCT01856933|FG000|Participant Flow|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
10883609|NCT00477490|FG007|Participant Flow|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
10883610|NCT00477490|FG008|Participant Flow|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
10883611|NCT00477490|OG000|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
10883612|NCT00477490|OG001|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883613|NCT00477490|OG002|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883614|NCT00477490|OG003|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883615|NCT00477490|OG004|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883616|NCT00477490|OG000|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883617|NCT00477490|OG001|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883618|NCT00477490|OG002|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883619|NCT00477490|OG003|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883620|NCT00477490|OG004|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
10883621|NCT00477490|OG005|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
10883622|NCT00477490|OG006|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
10883623|NCT00477490|OG007|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
10883624|NCT00477490|EG000|Reported Event|Part I: Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study.
10883625|NCT00477490|EG001|Reported Event|Part I: Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study.
11147297|NCT01856933|OG000|Outcome|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
10883626|NCT00477490|EG002|Reported Event|Part I: Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study.
10883627|NCT00477490|EG003|Reported Event|Part I: Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study.
10883628|NCT00477490|EG004|Reported Event|Part I: Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
10883629|NCT00477490|EG005|Reported Event|Part II: Desmopressin Melt 10 μg|Participants who took desmopressin melt 10 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
10883630|NCT00477490|EG006|Reported Event|Part II: Desmopressin Melt 25 μg|Participants who took desmopressin melt 25 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
10883631|NCT00477490|EG007|Reported Event|Part II: Desmopressin Melt 50 μg|Participants who took desmopressin melt 50 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
10883632|NCT00477490|EG008|Reported Event|Part II: Desmopressin Melt 100 μg|Participants who took desmopressin melt 100 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
10883633|NCT00477490|EG009|Reported Event|Part II: Placebo to Desmopressin Melt 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime
10883634|NCT00477490|EG010|Reported Event|Part II: Placebo to Desmopressin Melt 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
10883635|NCT00477490|EG011|Reported Event|Part II: Placebo to Desmopressin Melt 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
10883636|NCT00477490|EG012|Reported Event|Part II: Placebo to Desmopressin Melt 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
10883637|NCT00477594|BG000|Baseline|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
10883638|NCT00477594|BG001|Baseline|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period.
10883639|NCT00477594|BG002|Baseline|Total|Total of all reporting groups
10883640|NCT00477594|FG000|Participant Flow|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
10883641|NCT00477594|FG001|Participant Flow|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period.
10883642|NCT00477594|OG000|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
10883643|NCT00477594|OG001|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period.
10883644|NCT00477594|EG000|Reported Event|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
10883645|NCT00477594|EG001|Reported Event|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period.
10883646|NCT00477607|BG000|Baseline|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
10883647|NCT00477607|BG001|Baseline|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
10883648|NCT00477607|BG002|Baseline|Total|Total of all reporting groups
10883649|NCT00477607|FG000|Participant Flow|Alpha-lipoic Acid|"Receiving alpha-lipoic acid during cisplatin treatment.~alpha-lipoic acid : Supplements (1200mg once a day) was administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
10883650|NCT00477607|FG001|Participant Flow|Placebo|"Receiving placebo during cisplatin treatment~Placebo supplements (1200mg once a day) were administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
10887172|NCT00499122|OG000|Outcome|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1~Cyclophosphamide~Docetaxel~Doxorubicin~NOV 002"
10850971|NCT03410992|EG008|Reported Event|Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
10883651|NCT00477607|OG000|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
10883652|NCT00477607|OG001|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
10883653|NCT00477607|EG000|Reported Event|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
10883654|NCT00477607|EG001|Reported Event|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
10883655|NCT00477633|BG000|Baseline|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
10883656|NCT00477633|FG000|Participant Flow|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
10883657|NCT00477633|OG000|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
10883658|NCT00477633|EG000|Reported Event|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
10883659|NCT00477659|BG000|Baseline|Donepezil|Participants received donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks.
10883660|NCT00477659|FG000|Participant Flow|Donepezil Hydrochloride|Participants received donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks.
10883661|NCT00477659|OG000|Outcome|Donepezil Hydrochloride|Participants received donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks.
11147298|NCT01856933|EG000|Reported Event|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
10883662|NCT00477659|EG000|Reported Event|Donepezil Hydrochloride|Participants received donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks.
10883663|NCT00477672|BG000|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
10883664|NCT00477672|BG001|Baseline|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
10883665|NCT00477672|BG002|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
10883666|NCT00477672|BG003|Baseline|Total|Total of all reporting groups
10883667|NCT00477672|FG000|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
10883668|NCT00477672|FG001|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
10883669|NCT00477672|FG002|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
11147299|NCT01857102|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
11147300|NCT01857102|FG000|Participant Flow|Etafilcon A/ Etafilcon A for Astigmatism|Subjects that first received the etafilcon A lens and then received the etafilcon A for Astigmatism lens.
10883670|NCT00477672|OG000|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
10883671|NCT00477672|OG001|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
10883672|NCT00477672|OG002|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
10883673|NCT00477672|EG000|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
10883674|NCT00477672|EG001|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
10883675|NCT00477672|EG002|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
10883676|NCT00477685|BG000|Baseline|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
10883677|NCT00477685|FG000|Participant Flow|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
10883678|NCT00477685|OG000|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
10883679|NCT00477685|EG000|Reported Event|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
10883680|NCT00477750|BG000|Baseline|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
11009888|NCT01104545|OG001|Outcome|0.25 mg b.i.d. MK-3614|Participants received single daily dose of 0.25 mg MK-3614 b.i.d.
11009889|NCT01104545|EG000|Reported Event|0.25 mg MK-3614 Panel A|Participants received a single oral dose of 0.25 mg MK-3614 after an 8-hour fast
11147301|NCT01857102|FG001|Participant Flow|Etafilcon A for Astigmatism/Etafilcon A|Subjects that first received the etafilcon A for Astigmatism lens and then received the etafilcon A lens.
11147302|NCT01857102|OG000|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
11147303|NCT01857102|OG001|Outcome|Etafilcon A for Astigmatism|Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
11147304|NCT01857102|OG000|Outcome|Etafilcon A|Subjects that received the etafilcon A lens during the first or second period of the study.
11147305|NCT01857102|OG001|Outcome|Etafilcon A for Astigmatism|Subjects that received etafilcon A for Astigmatism lens in either the first or second period of the study.
11147306|NCT01857102|EG000|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
11147307|NCT01857102|EG001|Reported Event|Etafilcon A for Astigmatism|Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
11147308|NCT01857206|BG000|Baseline|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
11147309|NCT01857206|BG001|Baseline|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
11147310|NCT01857206|BG002|Baseline|TOTAL|Total of all reporting groups
11147311|NCT01857206|FG000|Participant Flow|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
11147312|NCT01857206|FG001|Participant Flow|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
11147313|NCT01857206|OG000|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
11147314|NCT01857206|OG001|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
11147315|NCT01857206|OG002|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
11147316|NCT01857206|OG003|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
11147317|NCT01857206|EG000|Reported Event|TIVc(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
11147318|NCT01857206|EG001|Reported Event|TIVf(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
11147319|NCT01857206|EG002|Reported Event|TIVc(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
11147320|NCT01857206|EG003|Reported Event|TIVf(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
11147321|NCT01857232|BG000|Baseline|Control ( Dexamethazon)|"ACUTE (day 1): IV OND + FOS + DEX~• DELAYED (days 2 to 4): Oral DEX"
11147322|NCT01857232|BG001|Baseline|Placebo|ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo
11147323|NCT01857232|BG002|Baseline|APD403 10MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 10 mg"
11147324|NCT01857232|BG003|Baseline|APD403 20MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 20 mg"
11147325|NCT01857232|BG004|Baseline|ADP403 40MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 40 mg"
11147326|NCT01857232|BG005|Baseline|Total|Total of all reporting groups
11147327|NCT01857232|FG000|Participant Flow|Control|"ACUTE (day 1): IV OND + FOS + DEX~• DELAYED (days 2 to 4): Oral DEX"
11147328|NCT01857232|FG001|Participant Flow|Placebo|ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo
11147329|NCT01857232|FG002|Participant Flow|APD403 10MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 10 mg"
11147330|NCT01857232|FG003|Participant Flow|APD403 20MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 20 mg"
11147331|NCT01857232|FG004|Participant Flow|ADP403 40MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 40 mg"
11147332|NCT01857232|OG000|Outcome|Control|"ACUTE (day 1): IV OND + FOS + DEX~• DELAYED (days 2 to 4): Oral DEX"
11147333|NCT01857232|OG001|Outcome|PLACEBO|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral Placebo"
11147334|NCT01857232|OG002|Outcome|APD403 10MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 10 mg"
11147335|NCT01857232|OG003|Outcome|ADP421 20MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 20 mg"
11147336|NCT01857232|OG004|Outcome|APD421 40MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 40 mg"
11147337|NCT01857232|OG001|Outcome|Placebo|ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo
11147338|NCT01857232|OG003|Outcome|APD403 20MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 20 mg"
11147339|NCT01857232|OG004|Outcome|ADP403 40MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 40 mg"
11147340|NCT01857232|EG000|Reported Event|Control|"ACUTE (day 1): IV OND + FOS + DEX~• DELAYED (days 2 to 4): Oral DEX"
11147341|NCT01857232|EG001|Reported Event|Placebo|ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo
11147342|NCT01857232|EG002|Reported Event|APD403 10MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 10 mg"
11147343|NCT01857232|EG003|Reported Event|APD403 20MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 20 mg"
11147344|NCT01857232|EG004|Reported Event|ADP403 40MG|"ACUTE (day 1): IV OND + APD403 20 mg~• DELAYED (days 2 to 4): Oral APD403 40 mg"
11147345|NCT01857258|BG000|Baseline|Baseline Participant Characteristics|All participants completed both arms of the cross-over study
10883681|NCT00477750|FG000|Participant Flow|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
10883682|NCT00477750|OG000|Outcome|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression> > Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression>~> Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
10883683|NCT00477750|OG000|Outcome|Treatment (Lenalidomide, Melphalan, Prednisone)|Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression
10883684|NCT00477750|OG000|Outcome|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
10883685|NCT00477750|EG000|Reported Event|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
10883686|NCT00477971|BG000|Baseline|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
10883687|NCT00477971|BG001|Baseline|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
10883688|NCT00477971|BG002|Baseline|Total|Total of all reporting groups
10883689|NCT00477971|FG000|Participant Flow|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
10883690|NCT00477971|FG001|Participant Flow|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
10883691|NCT00477971|OG000|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
10883692|NCT00477971|OG001|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
10883693|NCT00477971|EG000|Reported Event|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
10883694|NCT00477971|EG001|Reported Event|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
10883695|NCT00478023|BG000|Baseline|Morphine|Morphine IR 20mg 4-6 hourly
10883696|NCT00478023|BG001|Baseline|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
10883697|NCT00478023|BG002|Baseline|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
10883698|NCT00478023|BG003|Baseline|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
10883699|NCT00478023|BG004|Baseline|Placebo|Matched Placebo 4 to 6 hourly
10883700|NCT00478023|BG005|Baseline|Total|Total of all reporting groups
10883701|NCT00478023|FG000|Participant Flow|Morphine|Morphine IR 20mg 4-6 hourly
10883702|NCT00478023|FG001|Participant Flow|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
10883703|NCT00478023|FG002|Participant Flow|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
10883704|NCT00478023|FG003|Participant Flow|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
10883705|NCT00478023|FG004|Participant Flow|Placebo|Matched Placebo 4 to 6 hourly
10883706|NCT00478023|OG000|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
10883707|NCT00478023|OG001|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
10883708|NCT00478023|OG002|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
10883709|NCT00478023|OG003|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
10883710|NCT00478023|OG004|Outcome|Placebo|Matched Placebo 4 to 6 hourly
10883711|NCT00478023|EG000|Reported Event|Morphine|Morphine IR 20mg 4-6 hourly
10883712|NCT00478023|EG001|Reported Event|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
10883713|NCT00478023|EG002|Reported Event|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
10883714|NCT00478023|EG003|Reported Event|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
10883715|NCT00478023|EG004|Reported Event|Placebo|Matched Placebo 4 to 6 hourly
10883716|NCT00478036|BG000|Baseline|Placebo Group|Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
10883717|NCT00478036|BG001|Baseline|Acular Group|Used acular LS
10883718|NCT00478036|BG002|Baseline|Predforte Group|Used predforte eye drops
10883719|NCT00478036|BG003|Baseline|Total|Total of all reporting groups
10883720|NCT00478036|FG000|Participant Flow|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
10883721|NCT00478036|FG001|Participant Flow|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
10883722|NCT00478036|FG002|Participant Flow|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
10883723|NCT00478036|OG000|Outcome|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
10883724|NCT00478036|OG001|Outcome|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
10883725|NCT00478036|OG002|Outcome|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
11147346|NCT01857258|FG000|Participant Flow|Green Tea First, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.~The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
11147347|NCT01857258|FG001|Participant Flow|Control First, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.~The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
11147348|NCT01857258|OG000|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
11147349|NCT01857258|OG001|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
11147350|NCT01857258|OG000|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
10883726|NCT00478036|EG000|Reported Event|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
10883727|NCT00478036|EG001|Reported Event|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
10883728|NCT00478036|EG002|Reported Event|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
10883729|NCT00478140|BG000|Baseline|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10883730|NCT00478140|FG000|Participant Flow|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10883731|NCT00478140|OG000|Outcome|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10883732|NCT00478140|EG000|Reported Event|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10883733|NCT00478192|BG000|Baseline|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
10883734|NCT00478192|BG001|Baseline|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
10883735|NCT00478192|BG002|Baseline|Regimen 3 Placebo|
10883736|NCT00478192|BG003|Baseline|Total|Total of all reporting groups
10883737|NCT00478192|FG000|Participant Flow|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
10883738|NCT00478192|FG001|Participant Flow|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
10883739|NCT00478192|FG002|Participant Flow|Regimen 3 Placebo|
10883740|NCT00478192|OG000|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
10883741|NCT00478192|OG001|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
10883742|NCT00478192|OG002|Outcome|Regimen 3 Placebo|
10883743|NCT00478192|OG000|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
10883744|NCT00478192|EG000|Reported Event|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
10883745|NCT00478192|EG001|Reported Event|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
10883746|NCT00478192|EG002|Reported Event|Regimen 3 Placebo|
10883747|NCT00478205|BG000|Baseline|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
10883748|NCT00478205|BG001|Baseline|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
10883749|NCT00478205|BG002|Baseline|Total|Total of all reporting groups
10883750|NCT00478205|FG000|Participant Flow|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
10883751|NCT00478205|FG001|Participant Flow|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
10883752|NCT00478205|OG000|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
10883753|NCT00478205|OG001|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
10883754|NCT00478205|EG000|Reported Event|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
10883755|NCT00478205|EG001|Reported Event|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
10883756|NCT00478218|BG000|Baseline|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
11147351|NCT01857258|OG001|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
11147352|NCT01857258|EG000|Reported Event|Green Tea, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
11147353|NCT01857258|EG001|Reported Event|Control, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
10883757|NCT00478218|BG001|Baseline|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
10883758|NCT00478218|BG002|Baseline|Total|Total of all reporting groups
11147354|NCT01857297|BG000|Baseline|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11147355|NCT01857297|BG001|Baseline|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11147356|NCT01857297|BG002|Baseline|Total|Total of all reporting groups
11147357|NCT01857297|FG000|Participant Flow|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11147358|NCT01857297|FG001|Participant Flow|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11147359|NCT01857297|OG000|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11147360|NCT01857297|OG001|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11147361|NCT01857297|EG000|Reported Event|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11147362|NCT01857297|EG001|Reported Event|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
11147363|NCT01857310|BG000|Baseline|Folic Acid and Zinc Supplementation|"5 mg folic acid and 30 mg elemental zinc, taken orally, daily for 6 months.~5 mg folic acid and 30 mg elemental zinc"
11147364|NCT01857310|BG001|Baseline|Placebo|"Matching placebo, taken orally daily for 6 months.~Placebo Comparator: Placebo"
10883759|NCT00478218|FG000|Participant Flow|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
10883760|NCT00478218|FG001|Participant Flow|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
10883761|NCT00478218|OG000|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
10883762|NCT00478218|OG001|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
10883763|NCT00478218|EG000|Reported Event|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
10883764|NCT00478218|EG001|Reported Event|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
10883765|NCT00478231|BG000|Baseline|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
10883766|NCT00478231|FG000|Participant Flow|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
10883767|NCT00478231|OG000|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
10883768|NCT00478231|EG000|Reported Event|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
10883769|NCT00478244|BG000|Baseline|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
10883770|NCT00478244|FG000|Participant Flow|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
10883771|NCT00478244|OG000|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
10883772|NCT00478244|EG000|Reported Event|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
10883773|NCT00478257|BG000|Baseline|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
10883774|NCT00478257|BG001|Baseline|Effect of Red Light|effect of red light on fatigue in women with breast cancer
10883775|NCT00478257|BG002|Baseline|Total|Total of all reporting groups
10883776|NCT00478257|FG000|Participant Flow|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
10883777|NCT00478257|FG001|Participant Flow|Effect of Red Light|effect of red light on fatigue in women with breast cancer
10883778|NCT00478257|OG000|Outcome|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
11147365|NCT01857310|BG002|Baseline|Total|Total of all reporting groups
10883779|NCT00478257|OG001|Outcome|Effect of Red Light|effect of red light on fatigue in women with breast cancer
10883780|NCT00478257|EG000|Reported Event|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
10883781|NCT00478257|EG001|Reported Event|Effect of Red Light|effect of red light on fatigue in women with breast cancer
10883782|NCT00478335|BG000|Baseline|Experimental First Then Standard|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily)."
10883783|NCT00478335|BG001|Baseline|Standard First Then Experimental|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight)."
10883784|NCT00478335|BG002|Baseline|Total|Total of all reporting groups
10883785|NCT00478335|FG000|Participant Flow|Experimental First Then Standard|"Experimental phase: 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily)."
10883786|NCT00478335|FG001|Participant Flow|Standard First Then Experimental|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight)."
10883787|NCT00478335|OG000|Outcome|Experimental First Then Standard|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~on subject weight"
10883788|NCT00478335|OG001|Outcome|Standard First Then Experimental|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight)."
10883789|NCT00478335|EG000|Reported Event|Experimental First Then Standard|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily)."
10883790|NCT00478335|EG001|Reported Event|Standard First Then Experimental|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight)."
10883791|NCT00478361|BG000|Baseline|Gemcitabine, Paclitaxel and Doxorubicin|Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 minutes; Doxorubicin 40 mg/m^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
11009890|NCT01104545|EG001|Reported Event|1.25 mg MK-3614 Panel A|Participants received a single oral dose of 1.25 mg MK-3614 after an 8-hour fast
10883792|NCT00478361|FG000|Participant Flow|Gemcitabine, Paclitaxel and Doxorubicin|Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 minutes; Doxorubicin 40 mg/m^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
11225394|NCT02367833|BG001|Baseline|Combined Oral Contraceptives (COC)|Apri (or generic equivalent - Reclipsen) (30µg/d EE, 150 µg/d desogestrel) is a monophasic dosing regimen of 21 active and 7 placebo pills. On Day 1 of the Intervention, participants in the COC group will begin taking the COC pill. Each participant in this group will ingest active pills from the first pack each day for the first 21 days. Pills ingested on days 22 through 28 are placebo pills. A second pill pack will begin on day 29 and pills with active ingredients will be ingested from the second pack each day for days 29-49. On day 50, the participants will immediately begin a 3rd pill pack, if the post-study testing is still occurring, and will ingest a pill with active ingredients from the third pack for days 50-56 (or for as long as the post-study testing is occurring).
11225395|NCT02367833|BG002|Baseline|Contraceptive Vaginal Ring (CVR)|Participants in the CVR group (NuvaRing - 15µg/d EE/120µg/d etonogestrel) will insert a vaginal ring into the vagina on Day 1 of the intervention. The vaginal ring will be removed and discarded after 3 weeks of continuous use (days 1-21 of continuous use and removed on day 22). There will be one week (days 22-28) that will be ring-free. A new ring will be inserted for days 29-49. On day 50, the second ring will be removed, and a third ring will be immediately inserted into the vagina (if the post-study testing is still occurring). The third ring will remain in the vagina for the last week of the post-study period (days 50-56). As soon as the post-study testing is complete, subjects will remove the ring.
11225396|NCT02367833|BG003|Baseline|Total|Total of all reporting groups
11225397|NCT02367833|FG000|Participant Flow|Combined Oral Contraceptives (COC)|Apri (or generic equivalent - Reclipsen) (30µg/d EE, 150 µg/d desogestrel) is a monophasic dosing regimen of 21 active and 7 placebo pills. On Day 1 of the Intervention, participants in the COC group will begin taking the COC pill. Each participant in this group will ingest active pills from the first pack each day for the first 21 days. Pills ingested on days 22 through 28 are placebo pills. A second pill pack will begin on day 29 and pills with active ingredients will be ingested from the second pack each day for days 29-49. On day 50, the participants will immediately begin a 3rd pill pack, if the post-study testing is still occurring, and will ingest a pill with active ingredients from the third pack for days 50-56 (or for as long as the post-study testing is occurring).
11225398|NCT02367833|FG001|Participant Flow|Contraceptive Vaginal Ring (CVR)|Participants in the CVR group (NuvaRing - 15µg/d EE/120µg/d etonogestrel) will insert a vaginal ring into the vagina on Day 1 of the intervention. The vaginal ring will be removed and discarded after 3 weeks of continuous use (days 1-21 of continuous use and removed on day 22). There will be one week (days 22-28) that will be ring-free. A new ring will be inserted for days 29-49. On day 50, the second ring will be removed, and a third ring will be immediately inserted into the vagina (if the post-study testing is still occurring). The third ring will remain in the vagina for the last week of the post-study period (days 50-56). As soon as the post-study testing is complete, subjects will remove the ring.
11225399|NCT02367833|FG002|Participant Flow|Control Group|The Control group will complete all procedures with the exception of contraceptive therapy.
11225400|NCT02367833|OG000|Outcome|Control Group|The Control group will complete all procedures with the exception of contraceptive therapy.
11225401|NCT02367833|OG001|Outcome|Combined Oral Contraceptives (COC)|Apri (or generic equivalent - Reclipsen) (30µg/d EE, 150 µg/d desogestrel) is a monophasic dosing regimen of 21 active and 7 placebo pills. On Day 1 of the Intervention, participants in the COC group will begin taking the COC pill. Each participant in this group will ingest active pills from the first pack each day for the first 21 days. Pills ingested on days 22 through 28 are placebo pills. A second pill pack will begin on day 29 and pills with active ingredients will be ingested from the second pack each day for days 29-49. On day 50, the participants will immediately begin a 3rd pill pack, if the post-study testing is still occurring, and will ingest a pill with active ingredients from the third pack for days 50-56 (or for as long as the post-study testing is occurring).
11225402|NCT02367833|OG002|Outcome|Contraceptive Vaginal Ring (CVR)|Participants in the CVR group (NuvaRing - 15µg/d EE/120µg/d etonogestrel) will insert a vaginal ring into the vagina on Day 1 of the intervention. The vaginal ring will be removed and discarded after 3 weeks of continuous use (days 1-21 of continuous use and removed on day 22). There will be one week (days 22-28) that will be ring-free. A new ring will be inserted for days 29-49. On day 50, the second ring will be removed, and a third ring will be immediately inserted into the vagina (if the post-study testing is still occurring). The third ring will remain in the vagina for the last week of the post-study period (days 50-56). As soon as the post-study testing is complete, subjects will remove the ring.
11225403|NCT02367833|EG000|Reported Event|Control Group|The Control group will complete all procedures with the exception of contraceptive therapy.
11341231|NCT03679494|OG000|Outcome|SDM Intervention Group|"Using shared decision making support tool for intervention~Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions"
11341232|NCT03679494|OG001|Outcome|Usual Care Group|No intervention, just continue using usual care
10883793|NCT00478361|OG000|Outcome|Gemcitabine, Paclitaxel and Doxorubicin|Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 minutes; Doxorubicin 40 mg/m^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
10883794|NCT00478361|EG000|Reported Event|Gemcitabine, Paclitaxel and Doxorubicin|Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 minutes; Doxorubicin 40 mg/m^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
10883795|NCT00478426|BG000|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.~Sunitinib Malate: Given PO"
11009891|NCT01104545|EG002|Reported Event|0.25 mg w/ Food MK-3614 Panel A|Participants received a single oral dose of 0.25 mg MK-3614 after ingesting a high-fat breakfest
10883796|NCT00478426|FG000|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.~Sunitinib Malate: Given PO"
10883797|NCT00478426|OG000|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.~Sunitinib Malate: Given PO"
10883798|NCT00478426|EG000|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.~Sunitinib Malate: Given PO"
10883799|NCT00478556|BG000|Baseline|Gastroview|Oral Gastroview prior to CT
10883800|NCT00478556|BG001|Baseline|Omnipaque|Oral Omnipaque prior to CT
10883801|NCT00478556|BG002|Baseline|Total|Total of all reporting groups
10883802|NCT00478556|FG000|Participant Flow|Gastroview Group|Patients will be given oral Gastroview (contrast) prior to Computerized Tomography (CT).
10883803|NCT00478556|FG001|Participant Flow|Omnipaque Group|Patients ill be given oral Omnipaque (contrast) prior to Computerized Tomography (CT).
10883804|NCT00478556|OG000|Outcome|Gastroview|Oral Gastroview prior to CT
10883805|NCT00478556|OG001|Outcome|Omnipaque|Oral Omnipaque prior to CT
11147366|NCT01857310|FG000|Participant Flow|Folic Acid and Zinc Supplementation|"5 mg folic acid and 30 mg elemental zinc, taken orally, daily for 6 months.~5 mg folic acid and 30 mg elemental zinc"
11147367|NCT01857310|FG001|Participant Flow|Placebo|"Matching placebo, taken orally daily for 6 months.~Placebo Comparator: Placebo"
10883806|NCT00478556|EG000|Reported Event|Gastroview|Oral Gastroview prior to CT
10883807|NCT00478556|EG001|Reported Event|Omnipaque|Oral Omnipaque prior to CT
11147368|NCT01857310|OG000|Outcome|Folic Acid and Zinc Supplementation|"5 mg folic acid and 30 mg elemental zinc, taken orally, daily for 6 months.~5 mg folic acid and 30 mg elemental zinc"
10883808|NCT00478569|BG000|Baseline|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
10883809|NCT00478569|FG000|Participant Flow|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
10883810|NCT00478569|OG000|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
10883811|NCT00478569|OG000|Outcome|3 Months|
10883812|NCT00478569|OG001|Outcome|12 Months|
10883813|NCT00478569|OG002|Outcome|18 Months|
10883814|NCT00478569|OG003|Outcome|24 Months|
10883815|NCT00478569|OG001|Outcome|6 Months|
10883816|NCT00478569|OG002|Outcome|12 Months|
10883817|NCT00478569|OG003|Outcome|18 Months|
11147369|NCT01857310|OG001|Outcome|Placebo|"Matching placebo, taken orally daily for 6 months.~Placebo Comparator: Placebo"
11147370|NCT01857310|EG000|Reported Event|Folic Acid and Zinc Supplementation|"5 mg folic acid and 30 mg elemental zinc, taken orally, daily for 6 months.~5 mg folic acid and 30 mg elemental zinc"
10883818|NCT00478569|OG004|Outcome|24 Months|
10883819|NCT00478569|EG000|Reported Event|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
10883820|NCT00478608|BG000|Baseline|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
10883821|NCT00478608|FG000|Participant Flow|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
10887173|NCT00499122|EG000|Reported Event|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
11147371|NCT01857310|EG001|Reported Event|Placebo|"Matching placebo, taken orally daily for 6 months.~Placebo Comparator: Placebo"
11147372|NCT01857323|BG000|Baseline|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
11147373|NCT01857323|FG000|Participant Flow|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
11147374|NCT01857323|OG000|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
10883822|NCT00478608|OG000|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
10883823|NCT00478608|EG000|Reported Event|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
10883824|NCT00478647|BG000|Baseline|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
10883825|NCT00478647|FG000|Participant Flow|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
10883826|NCT00478647|OG000|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
10883827|NCT00478647|EG000|Reported Event|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
10883828|NCT00478673|BG000|Baseline|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
10883829|NCT00478673|FG000|Participant Flow|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
10883830|NCT00478673|OG000|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
10883831|NCT00478673|EG000|Reported Event|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
10883832|NCT00478777|BG000|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
10883833|NCT00478777|FG000|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
10883834|NCT00478777|OG000|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
10883835|NCT00478777|EG000|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
10883836|NCT00478881|BG000|Baseline|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
10883837|NCT00478881|BG001|Baseline|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
10883838|NCT00478881|BG002|Baseline|Total|Total of all reporting groups
10883839|NCT00478881|FG000|Participant Flow|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
10883840|NCT00478881|FG001|Participant Flow|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
10883841|NCT00478881|OG000|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
10883842|NCT00478881|OG001|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
10883843|NCT00478881|EG000|Reported Event|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
10883844|NCT00478881|EG001|Reported Event|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
10883845|NCT00478933|BG000|Baseline|ICD Therapy, Blood Sampling|"Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.~Blood sampling: Blood sampling for genetic analysis on pre-specified SNPs"
10883846|NCT00478933|FG000|Participant Flow|ICD Therapy, Blood Sampling|"Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.~Blood sampling: Blood sampling for genetic analysis of the pre-identified SNPs"
10883847|NCT00478933|OG000|Outcome|c.393C>T CC Genotype|Patients in this group have two copies of the major (C) allele for the c.393C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883848|NCT00478933|OG001|Outcome|c.393C>T CT Genotype|Patients in this group have one copy of each allele (C and T) for the c.393C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883849|NCT00478933|OG002|Outcome|c.393C>T TT Genotype|Patients in this group have two copies of the minor (T) allele for the c.393C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883850|NCT00478933|OG000|Outcome|c.2273C>T CC Genotype|Patients in this group have two copies of the major (C) allele for the c.2273C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883851|NCT00478933|OG001|Outcome|c.2273C>T CT Genotype|Patients in this group have one copy of each (C and T) allele for the c.2273C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883852|NCT00478933|OG002|Outcome|c.393C>T TT Genotype|Patients in this group have two copies of the minor (T) allele for the c.2273C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883853|NCT00478933|OG000|Outcome|c.2291C>T CC Genotype|Patients in this group have two copies of the major (C) allele for the c.2291C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883854|NCT00478933|OG001|Outcome|c.2291C>T CT Genotype|Patients in this group have one copy of each allele (C and T) for the c.2291C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883855|NCT00478933|OG002|Outcome|c.2291C>T TT Genotype|Patients in this group have two copies of the minor (T) allele for the c.2291C>T single nucleotide polymorphism (SNP) in the GNAS gene
10883856|NCT00478933|OG000|Outcome|GNAQ c.-909/-908GC>TT GC/GC Genotype|Patients in this group have two copies of the major (GC) allele for the c.-909/-908GC>TT single nucleotide polymorphism (SNP) in the GNAQ gene
10883857|NCT00478933|OG001|Outcome|GNAQ c.-909/-908GC>TT GC/TT Genotype|Patients in this group have one copy of each allele (GC and TT) for the c.-909/-908GC>TT single nucleotide polymorphism (SNP) in the GNAS gene
10883858|NCT00478933|OG002|Outcome|GNAQ c.-909/-908GC>TT TT/TT Genotype|Patients in this group have two copies of the minor (TT) allele for the c.-909/-908GC>TT single nucleotide polymorphism (SNP) in the GNAQ gene
10883859|NCT00478933|OG000|Outcome|c.-382G>A GG Genotype|Patients in this group have two copies of the major (G) allele for the c.-382G>A single nucleotide polymorphism (SNP) in the GNAQ gene
10883860|NCT00478933|OG001|Outcome|c.-382G>A GA Genotype|Patients in this group have one copy of each allele (C and T) for the c.-382G>A single nucleotide polymorphism (SNP) in the GNAQ gene
10883861|NCT00478933|OG002|Outcome|c.-382G>A AA Genotype|Patients in this group have two copies of the minor (A) allele for the c.-382G>A single nucleotide polymorphism (SNP) in the GNAQ gene
10883862|NCT00478933|OG000|Outcome|c.-387G>A GG Genotype|Patients in this group have two copies of the major (G) allele for the c.-387G>A single nucleotide polymorphism (SNP) in the GNAQ gene
10883863|NCT00478933|OG001|Outcome|c.-387G>A GA Genotype|Patients in this group have one copy of each allele (C and T) for the c.-387G>A single nucleotide polymorphism (SNP) in the GNAQ gene
10883864|NCT00478933|OG002|Outcome|c.-387G>A AA Genotype|Patients in this group have two copies of the minor (A) allele for the c.-387G>A single nucleotide polymorphism (SNP) in the GNAQ gene
10883865|NCT00478933|OG000|Outcome|c.825C>T CC Genotype|Patients in this group have two copies of the major (G) allele for the c.825C>T CC single nucleotide polymorphism (SNP) in the GNB3 gene
10883866|NCT00478933|OG001|Outcome|c.825C>T CT Genotype|Patients in this group have one copy of each allele (C and T) for the c.825C>T single nucleotide polymorphism (SNP) in the GNB3 gene
10883867|NCT00478933|OG002|Outcome|c.825C>T TT Genotype|Patients in this group have two copies of the minor (A) allele for the c.825C>T single nucleotide polymorphism (SNP) in the GNB3 gene
10883868|NCT00478933|EG000|Reported Event|ICD Therapy, Blood Sampling|"Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.~Blood sampling: Blood sampling for genetic analysis on pre-identified SNPs"
10883869|NCT00479037|BG000|Baseline|PTH(1-84)|Once daily subcutaneous injection
10883870|NCT00479037|BG001|Baseline|Strontium Ranelate|One sachet (2 g) per day, suspended in water
10883871|NCT00479037|BG002|Baseline|Total|Total of all reporting groups
10883872|NCT00479037|FG000|Participant Flow|PTH(1-84)|Once daily subcutaneous injection
10883873|NCT00479037|FG001|Participant Flow|Strontium Ranelate|One sachet (2 g) per day, suspended in water
10883874|NCT00479037|OG000|Outcome|PTH(1-84)|Once daily subcutaneous injection
10883875|NCT00479037|OG001|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
10883876|NCT00479037|EG000|Reported Event|PTH(1-84)|Once daily subcutaneous injection
10883877|NCT00479037|EG001|Reported Event|Strontium Ranelate|One sachet (2 g) per day, suspended in water
10883878|NCT00479089|BG000|Baseline|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
10883879|NCT00479089|BG001|Baseline|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
10883880|NCT00479089|BG002|Baseline|Total|Total of all reporting groups
10883881|NCT00479089|FG000|Participant Flow|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
10883882|NCT00479089|FG001|Participant Flow|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
10883883|NCT00479089|OG000|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
10883884|NCT00479089|OG001|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
10883885|NCT00479089|EG000|Reported Event|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
10883886|NCT00479089|EG001|Reported Event|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
10883887|NCT00479115|BG000|Baseline|AMD3100|"AMD3100: 240 mcg/kg subcutaneously, minimum of two days; maximum of eight days~AmCell CliniMACs: CD34+ cell selection from peripheral collection"
10883888|NCT00479115|FG000|Participant Flow|AMD3100|"AMD3100: 240 mcg/kg subcutaneously, minimum of two days; maximum of eight days~AmCell CliniMACs: CD34+ cell selection from peripheral collection"
10883889|NCT00479115|OG000|Outcome|AMD3100|"AMD3100: 240 mcg/kg subcutaneously, minimum of two days; maximum of eight days~AmCell CliniMACs: CD34+ cell selection from peripheral collection"
10883890|NCT00479115|EG000|Reported Event|AMD3100|"AMD3100: 240 mcg/kg subcutaneously, minimum of two days; maximum of eight days~AmCell CliniMACs: CD34+ cell selection from peripheral collection"
10883891|NCT00479154|BG000|Baseline|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
10883892|NCT00479154|BG001|Baseline|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
10883893|NCT00479154|BG002|Baseline|Total|Total of all reporting groups
10883894|NCT00479154|FG000|Participant Flow|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
10883895|NCT00479154|FG001|Participant Flow|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
10883896|NCT00479154|OG000|Outcome|Placebo|Injection into set of leg muscles with Placebo.
10883897|NCT00479154|OG001|Outcome|Botulinum Toxin|Injection of Botulinum Toxin (90 mU per leg).
10883898|NCT00479154|EG000|Reported Event|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
10883899|NCT00479154|EG001|Reported Event|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
10883900|NCT00479232|BG000|Baseline|Vorinostat + Decitabine, Concurrent|(concurrent) Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
10883901|NCT00479232|BG001|Baseline|Vorinostat + Decitabine, Sequential|(sequential) Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
10883902|NCT00479232|BG002|Baseline|Total|Total of all reporting groups
10883903|NCT00479232|FG000|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily (qd) on Days 1 to 7 in a 28 day cycle, along with decitabine intravenous (IV) 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883904|NCT00479232|FG001|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883905|NCT00479232|FG002|Participant Flow|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883906|NCT00479232|FG003|Participant Flow|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883907|NCT00479232|FG004|Participant Flow|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883908|NCT00479232|FG005|Participant Flow|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883909|NCT00479232|OG000|Outcome|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883910|NCT00479232|OG001|Outcome|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883911|NCT00479232|OG002|Outcome|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883912|NCT00479232|OG003|Outcome|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883913|NCT00479232|OG004|Outcome|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883914|NCT00479232|OG005|Outcome|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883915|NCT00479232|OG000|Outcome|Refractory or Relapsed AML, Concurrent|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine concurrently.
10883916|NCT00479232|OG001|Outcome|Refractory or Relapsed AML, Sequential|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine sequentially.
10883917|NCT00479232|OG000|Outcome|Untreated AML or Intermediate, Concurrent|"Participants with Untreated AML or Intermediate-High~Risk MDS who were treated with vorinostat and Decitabine~concurrently."
10883918|NCT00479232|OG001|Outcome|Untreated AML or Intermediate, Sequential|"Participants with Untreated AML or Intermediate-High~Risk MDS who were treated with vorinostat and Decitabine~sequentially."
11147375|NCT01857323|EG000|Reported Event|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
11147376|NCT01857362|BG000|Baseline|Overall Study|All treatment arms
11147377|NCT01857362|FG000|Participant Flow|Nitisinone 1 x 20 mg, Then Nitisinone 2 x 10 mg|Participants first received one nitisinone capsule of 20 mg. After washout of 3 weeks participants then received two nitisinone capsules of 10 mg.
11147378|NCT01857362|FG001|Participant Flow|Nitisinone 2 x 10 mg, Then Nitisinone 1 x 20 mg|Participants first received two nitisinone capsules of 10 mg. After washout of 3 weeks participants then received one nitisinone capsule of 20 mg.
10883919|NCT00479232|EG000|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883920|NCT00479232|EG001|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883921|NCT00479232|EG002|Reported Event|Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
11147379|NCT01857362|OG000|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
11147380|NCT01857362|OG001|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
11147381|NCT01857362|EG000|Reported Event|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
11147382|NCT01857362|EG001|Reported Event|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
11147383|NCT01857531|BG000|Baseline|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily for the first 3 days, 800mg daily for the next 3 days and 1200mg daily for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
11147384|NCT01857531|FG000|Participant Flow|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
11147385|NCT01857531|OG000|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
11147386|NCT01857531|EG000|Reported Event|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
11147387|NCT01857583|BG000|Baseline|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
11147388|NCT01857583|BG001|Baseline|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
11147389|NCT01857583|BG002|Baseline|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
11147390|NCT01857583|BG003|Baseline|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min)"
10883922|NCT00479232|EG003|Reported Event|Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883923|NCT00479232|EG004|Reported Event|Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
11147391|NCT01857583|BG004|Baseline|Total|Total of all reporting groups
10883924|NCT00479232|EG005|Reported Event|Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(sequential) orinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
10883925|NCT00479336|BG000|Baseline|Placebo|Placebo, 1 tablet a day
10883926|NCT00479336|BG001|Baseline|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
10883927|NCT00479336|BG002|Baseline|OPC-41061 15 mg|15 mg, 1 tablet a day
10883928|NCT00479336|BG003|Baseline|OPC-41061 30 mg|30 mg, 1 tablet a day
10883929|NCT00479336|BG004|Baseline|Total|Total of all reporting groups
11147392|NCT01857583|FG000|Participant Flow|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
11147393|NCT01857583|FG001|Participant Flow|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
11147394|NCT01857583|FG002|Participant Flow|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
11147395|NCT01857583|FG003|Participant Flow|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min) Fondaparinux"
11147396|NCT01857583|OG000|Outcome|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
11147397|NCT01857583|OG001|Outcome|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
11147398|NCT01857583|OG002|Outcome|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
11147399|NCT01857583|OG003|Outcome|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min)"
11147400|NCT01857583|EG000|Reported Event|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
10883930|NCT00479336|FG000|Participant Flow|Placebo|Placebo, 1 tablet a day
10883931|NCT00479336|FG001|Participant Flow|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
10883932|NCT00479336|FG002|Participant Flow|OPC-41061 15 mg|15 mg, 1 tablet a day
10883933|NCT00479336|FG003|Participant Flow|OPC-41061 30 mg|30 mg, 1 tablet a day
10883934|NCT00479336|OG000|Outcome|Placebo|Placebo, 1 tablet a day
10883935|NCT00479336|OG001|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
10883936|NCT00479336|OG002|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
10883937|NCT00479336|OG003|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
10883938|NCT00479336|EG000|Reported Event|Placebo|Placebo, 1 tablet a day
10883939|NCT00479336|EG001|Reported Event|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
10883940|NCT00479336|EG002|Reported Event|OPC-41061 15 mg|15 mg, 1 tablet a day
10883941|NCT00479336|EG003|Reported Event|OPC-41061 30 mg|30 mg, 1 tablet a day
10883942|NCT00479388|BG000|Baseline|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
10883943|NCT00479388|BG001|Baseline|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
11147401|NCT01857583|EG001|Reported Event|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
11147402|NCT01857583|EG002|Reported Event|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
11147403|NCT01857583|EG003|Reported Event|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)"
10883944|NCT00479388|BG002|Baseline|Total|Total of all reporting groups
10883945|NCT00479388|FG000|Participant Flow|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
10883946|NCT00479388|FG001|Participant Flow|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
10883947|NCT00479388|OG000|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
10883948|NCT00479388|OG001|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
10883949|NCT00479388|EG000|Reported Event|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
10883950|NCT00479388|EG001|Reported Event|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
10883951|NCT00479401|BG000|Baseline|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
10883952|NCT00479401|BG001|Baseline|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
10883953|NCT00479401|BG002|Baseline|Placebo|Placebo to PPX ER once and to PPX IR three times a day
10883954|NCT00479401|BG003|Baseline|Total|Total of all reporting groups
10883955|NCT00479401|FG000|Participant Flow|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
10883956|NCT00479401|FG001|Participant Flow|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
10883957|NCT00479401|FG002|Participant Flow|Placebo|Placebo to PPX ER once and to PPX IR three times a day
10883958|NCT00479401|OG000|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
10883959|NCT00479401|OG001|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
11147404|NCT01857622|BG000|Baseline|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
11147405|NCT01857622|BG001|Baseline|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
11147406|NCT01857622|BG002|Baseline|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
11147407|NCT01857622|BG003|Baseline|Total|Total of all reporting groups
11147408|NCT01857622|FG000|Participant Flow|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
11147409|NCT01857622|FG001|Participant Flow|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
11147410|NCT01857622|FG002|Participant Flow|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
11147411|NCT01857622|OG000|Outcome|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
11147412|NCT01857622|OG001|Outcome|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
11147413|NCT01857622|OG002|Outcome|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
11147414|NCT01857622|EG000|Reported Event|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
10883960|NCT00479401|OG002|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
10883961|NCT00479401|EG000|Reported Event|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
11147415|NCT01857622|EG001|Reported Event|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
11147416|NCT01857622|EG002|Reported Event|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
11147417|NCT01857713|BG000|Baseline|Fitted With Reza Band UES Assist Device|Patients were their own control and Fitted with Reza Band UES Assist Device. Results were obtained by measuring symptoms at baseline and then compared at each of the prescribed follow-up visits.
11147418|NCT01857713|FG000|Participant Flow|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and served as their own control. Baseline measures were comported to follow-up visit measures.
10883962|NCT00479401|EG001|Reported Event|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
10883963|NCT00479401|EG002|Reported Event|Placebo|Placebo to PPX ER once and to PPX IR three times a day
10883964|NCT00479466|BG000|Baseline|Placebo|
10883965|NCT00479466|BG001|Baseline|MK0893 20 mg|
10883966|NCT00479466|BG002|Baseline|MK0893 40 mg|
10883967|NCT00479466|BG003|Baseline|MK0893 60 mg|
10883968|NCT00479466|BG004|Baseline|MK0893 80 mg|
10883969|NCT00479466|BG005|Baseline|Metformin HCL|
10883970|NCT00479466|BG006|Baseline|Total|Total of all reporting groups
10883971|NCT00479466|FG000|Participant Flow|Placebo|
10883972|NCT00479466|FG001|Participant Flow|MK0893 20 mg|
10883973|NCT00479466|FG002|Participant Flow|MK0893 40 mg|
10883974|NCT00479466|FG003|Participant Flow|MK0893 60 mg|
10883975|NCT00479466|FG004|Participant Flow|MK0893 80 mg|
10883976|NCT00479466|FG005|Participant Flow|Metformin HCL|
10883977|NCT00479466|OG000|Outcome|Placebo|
10883978|NCT00479466|OG001|Outcome|MK0893 20 mg|
10883979|NCT00479466|OG002|Outcome|MK0893 40 mg|
10883980|NCT00479466|OG003|Outcome|MK0893 60 mg|
10883981|NCT00479466|OG004|Outcome|MK0893 80 mg|
10883982|NCT00479466|OG005|Outcome|Metformin HCL|
10883983|NCT00479466|EG000|Reported Event|Placebo|
10883984|NCT00479466|EG001|Reported Event|MK0893 20 mg|
10883985|NCT00479466|EG002|Reported Event|MK0893 40 mg|
10883986|NCT00479466|EG003|Reported Event|MK0893 60 mg|
10883987|NCT00479466|EG004|Reported Event|MK0893 80 mg|
11009892|NCT01104545|EG003|Reported Event|0.75 mg MK-3614 Panel A|Participant received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
11009893|NCT01104545|EG004|Reported Event|Placebo Panel A|Participants received a single oral dose of placebo for MK-3614 after an 8-hour fast
11009894|NCT01104545|EG005|Reported Event|0.5 mg MK-3614 Panel B|Participants received a single oral dose of 0.50 mg MK-3614 after an 8-hour fast
11147419|NCT01857713|OG000|Outcome|Reza Band|Participants fitted with Reza Band UES Assist Device
11147420|NCT01857713|OG000|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
11147421|NCT01857713|OG000|Outcome|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
11147422|NCT01857713|EG000|Reported Event|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and were their own controls. Baseline measures were compared to each of the prescribed follow-up visit measures.
11147423|NCT01857869|BG000|Baseline|GSK257049-0,1,7M Group|Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
11147424|NCT01857869|BG001|Baseline|GSK257049-0,1,2M Group|Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
11147425|NCT01857869|BG002|Baseline|Infectivity Control Group|Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).
11147426|NCT01857869|BG003|Baseline|GSK257049-0,1,7M P-NoBo Group|Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
11147427|NCT01857869|BG004|Baseline|GSK257049-0,1,7M P-Bo Group|Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147428|NCT01857869|BG005|Baseline|GSK257049-0,1,7M NP-Bo Group|Subjects from GSK257049-0,1,7M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147429|NCT01857869|BG006|Baseline|GSK257049-0,1,2M P-NoBo Group|Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147430|NCT01857869|BG007|Baseline|GSK257049-0,1,2M P-Bo Group|Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147431|NCT01857869|BG008|Baseline|GSK257049-0,1,2M NP-Bo Group|Subjects from GSK257049-0,1,2M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147432|NCT01857869|BG009|Baseline|Control Group Follow-up|Subjects from Control Group in Primary Phase who remained uninfected with P. falciparum malaria and enrolled as infectivity controls for Follow-up Phase to undergo sporozoite rechallange.
11147433|NCT01857869|BG010|Baseline|Total|Total of all reporting groups
11147434|NCT01857869|FG000|Participant Flow|GSK257049-0,1,7M Group|Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (controlled human malaria infection [CHMI]).
11147435|NCT01857869|FG001|Participant Flow|GSK257049-0,1,2M Group|Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
11147436|NCT01857869|FG002|Participant Flow|Infectivity Control Group|Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).
11147437|NCT01857869|FG003|Participant Flow|GSK257049-0,1,7M P-NoBo Group|Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
11147438|NCT01857869|FG004|Participant Flow|GSK257049-0,1,7M P-Bo Group|Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147439|NCT01857869|FG005|Participant Flow|GSK257049-0,1,7M NP-Bo Group|Subjects from GSK257049-0,1,7M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147440|NCT01857869|FG006|Participant Flow|GSK257049-0,1,2M P-NoBo Group|Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147441|NCT01857869|FG007|Participant Flow|GSK257049-0,1,2M P-Bo Group|Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received a booster fractional (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147442|NCT01857869|FG008|Participant Flow|GSK257049-0,1,2M NP-Bo Group|Subjects from GSK257049-0,1,2M Group who were not protected (NP) during first CHMI and who received a booster fractional (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147443|NCT01857869|FG009|Participant Flow|Control Group Follow-up|Subjects from Control Group in Primary Phase who remained uninfected with P. falciparum malaria and enrolled as infectivity controls for Follow-up Phase to undergo sporozoite rechallange.
11147444|NCT01857869|OG000|Outcome|GSK257049-0,1,7M Group|Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
11147445|NCT01857869|OG001|Outcome|GSK257049-0,1,2M Group|Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
11147446|NCT01857869|OG002|Outcome|Infectivity Control Group|Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).
11147447|NCT01857869|OG000|Outcome|GSK257049-0,1,7M P-NoBo Group|Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
11147448|NCT01857869|OG001|Outcome|GSK257049-0,1,7M P-Bo Group|Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147449|NCT01857869|OG002|Outcome|GSK257049-0,1,7M NP-Bo Group|Subjects from GSK257049-0,1,7M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147450|NCT01857869|OG003|Outcome|GSK257049-0,1,2M P-NoBo Group|Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147451|NCT01857869|OG004|Outcome|GSK257049-0,1,2M P-Bo Group|Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
10883988|NCT00479466|EG005|Reported Event|Metformin HCL|
11147452|NCT01857869|OG005|Outcome|GSK257049-0,1,2M NP-Bo Group|Subjects from GSK257049-0,1,2M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147453|NCT01857869|OG006|Outcome|Control Group Follow-up|Subjects from Control Group in Primary Phase who remained uninfected with P. falciparum malaria and enrolled as infectivity controls for Follow-up Phase to undergo sporozoite rechallange.
11147454|NCT01857869|OG002|Outcome|GSK257049-0,1,2M P-NoBo Group|Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147455|NCT01857869|OG003|Outcome|GSK257049-0,1,2M P-Bo Group|Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147456|NCT01857869|OG004|Outcome|GSK257049-0,1,2M NP-Bo Group|Subjects from GSK257049-0,1,2M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
11147457|NCT01857869|OG005|Outcome|Control Group Follow-up|Subjects from Control Group in Primary Phase who remained uninfected with P. falciparum malaria and enrolled as infectivity controls for Follow-up Phase to undergo sporozoite rechallange.
11147458|NCT01857869|OG000|Outcome|Boosted Group|Pooled group comprising subjects from the GSK257049-0,1,7M P-Bo Group; GSK257049-0,1,7M NP-Bo Group; GSK257049-0,1,2M P-Bo Group and GSK257049-0,1,2M NP-Bo Group (protected and not protected subjects from the Primary Phase groups, that received a low fractional formulation booster dose of GSK257049 vaccine).
11147459|NCT01857869|OG000|Outcome|Non Boosted Group|Pooled group comprising subjects from the GSK257049-0,1,7M P-NoBo and GSK257049-0,1,2M P-NoBo Group (protected subjects from the Primary Phase groups, that did not receive a booster dose of GSK257049 vaccine.
11147460|NCT01857869|OG001|Outcome|Boosted Group|Pooled group comprising subjects from the GSK257049-0,1,7M P-Bo Group; GSK257049-0,1,7M NP-Bo Group; GSK257049-0,1,2M P-Bo Group and GSK257049-0,1,2M NP-Bo Group (protected and not protected subjects from the Primary Phase groups, that received a low fractional formulation booster dose of GSK257049 vaccine).
11147461|NCT01857869|OG002|Outcome|Control Group Follow-up|Subjects from Control Group in Primary Phase who remained uninfected with P. falciparum malaria and enrolled as infectivity controls for Follow-up Phase.
11147462|NCT01857869|EG000|Reported Event|GSK257049-0,1,7M Group|Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
11147463|NCT01857869|EG001|Reported Event|GSK257049-0,1,2M Group|Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
11147464|NCT01857869|EG002|Reported Event|Infectivity Control Group|Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).
10883989|NCT00479557|BG000|Baseline|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11009895|NCT01104545|EG006|Reported Event|0.75 mg MK-3614 Panel B|Participants received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
11147465|NCT01857882|BG000|Baseline|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
11147466|NCT01857882|BG001|Baseline|Standard Care|Routine pre-consultation education
11147467|NCT01857882|BG002|Baseline|Total|Total of all reporting groups
11150122|NCT01875861|OG000|Outcome|Intervention|"Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.~Evidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase."
10883990|NCT00479557|BG001|Baseline|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10883991|NCT00479557|BG002|Baseline|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11147468|NCT01857882|FG000|Participant Flow|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
11147469|NCT01857882|FG001|Participant Flow|Standard Care|Routine pre-consultation education
11147470|NCT01857882|OG000|Outcome|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
11147471|NCT01857882|OG001|Outcome|Standard Care|Routine pre-consultation education
11147472|NCT01857882|EG000|Reported Event|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
11147473|NCT01857882|EG001|Reported Event|Standard Care|Routine pre-consultation education
11147474|NCT01857973|BG000|Baseline|Hybrid Closed Loop|"In-clinic evaluation of the HCL System under various conditions.~Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose."
11147475|NCT01857973|FG000|Participant Flow|Hybrid Closed Loop|"In-clinic evaluation of the HCL System under various conditions.~Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose."
11147476|NCT01857973|OG000|Outcome|Hybrid Closed Loop|"In-clinic evaluation of the HCL System under various conditions.~Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose."
11147477|NCT01857973|EG000|Reported Event|Hybrid Closed Loop|"In-clinic evaluation of the HCL System under various conditions.~Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose."
11147478|NCT01857986|BG000|Baseline|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
11147479|NCT01857986|BG001|Baseline|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
11147480|NCT01857986|BG002|Baseline|Total|Total of all reporting groups
11147481|NCT01857986|FG000|Participant Flow|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
11147482|NCT01857986|FG001|Participant Flow|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
11150123|NCT01875861|OG001|Outcome|Comparison|"Usual care, in the context of the MIAMI Project."
10883992|NCT00479557|BG003|Baseline|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10883993|NCT00479557|BG004|Baseline|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10883994|NCT00479557|BG005|Baseline|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10883995|NCT00479557|BG006|Baseline|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10883996|NCT00479557|BG007|Baseline|Total|Total of all reporting groups
11009896|NCT01104545|EG007|Reported Event|0.25 mg b.i.d. MK-3614 Panel B|Participants received a single daily dose of 0.25 mg MK-3614 b.i.d.
10883997|NCT00479557|FG000|Participant Flow|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10883998|NCT00479557|FG001|Participant Flow|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10883999|NCT00479557|FG002|Participant Flow|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884000|NCT00479557|FG003|Participant Flow|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884001|NCT00479557|FG004|Participant Flow|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884002|NCT00479557|FG005|Participant Flow|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884003|NCT00479557|FG006|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884004|NCT00479557|OG000|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884005|NCT00479557|OG001|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884006|NCT00479557|OG002|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884007|NCT00479557|OG003|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884008|NCT00479557|OG004|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884009|NCT00479557|OG005|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11341233|NCT03679494|EG000|Reported Event|SDM Intervention Group|"Using shared decision making support tool for intervention~Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions"
10884010|NCT00479557|OG006|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884011|NCT00479557|OG000|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884012|NCT00479557|OG001|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11009897|NCT01104545|EG008|Reported Event|0.25 mg t.i.d MK-3614 Panel B|Participants received a single daily oral dose of 0.25 mg MK-3614 t.i.d.
11341234|NCT03679494|EG001|Reported Event|Usual Care Group|No intervention, just continue using usual care
11341235|NCT03679741|BG000|Baseline|All Dispensed Subjects|All subjects dispensed at least one study lens regardless of randomization.
10884013|NCT00479557|OG002|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884014|NCT00479557|OG003|Outcome|ACC 10 μg|Participants received 10 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884015|NCT00479557|OG004|Outcome|ACC 30 μg|Participants received 30 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884016|NCT00479557|OG005|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884017|NCT00479557|EG000|Reported Event|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884018|NCT00479557|EG001|Reported Event|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884019|NCT00479557|EG002|Reported Event|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884020|NCT00479557|EG003|Reported Event|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884021|NCT00479557|EG004|Reported Event|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884022|NCT00479557|EG005|Reported Event|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884023|NCT00479557|EG006|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10884024|NCT00479674|BG000|Baseline|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
11009898|NCT01104545|EG009|Reported Event|Placebo Panel B|Participants received a single oral dose of placebo for MK-3614 after an 8-hour fast
10884025|NCT00479674|FG000|Participant Flow|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
10884026|NCT00479674|OG000|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
10887174|NCT00499174|BG000|Baseline|Active Surveillance|Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
11225404|NCT02367833|EG001|Reported Event|Combined Oral Contraceptives (COC)|Apri (or generic equivalent - Reclipsen) (30µg/d EE, 150 µg/d desogestrel) is a monophasic dosing regimen of 21 active and 7 placebo pills. On Day 1 of the Intervention, participants in the COC group will begin taking the COC pill. Each participant in this group will ingest active pills from the first pack each day for the first 21 days. Pills ingested on days 22 through 28 are placebo pills. A second pill pack will begin on day 29 and pills with active ingredients will be ingested from the second pack each day for days 29-49. On day 50, the participants will immediately begin a 3rd pill pack, if the post-study testing is still occurring, and will ingest a pill with active ingredients from the third pack for days 50-56 (or for as long as the post-study testing is occurring).
11225405|NCT02367833|EG002|Reported Event|Contraceptive Vaginal Ring (CVR)|Participants in the CVR group (NuvaRing - 15µg/d EE/120µg/d etonogestrel) will insert a vaginal ring into the vagina on Day 1 of the intervention. The vaginal ring will be removed and discarded after 3 weeks of continuous use (days 1-21 of continuous use and removed on day 22). There will be one week (days 22-28) that will be ring-free. A new ring will be inserted for days 29-49. On day 50, the second ring will be removed, and a third ring will be immediately inserted into the vagina (if the post-study testing is still occurring). The third ring will remain in the vagina for the last week of the post-study period (days 50-56). As soon as the post-study testing is complete, subjects will remove the ring.
11225406|NCT02367859|BG000|Baseline|Treatment (Dabrafenib)|Patients receive dabrafenib orally twice daily every 12 hours plus trametinib daily orally for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease is judged to be not amenable to resection will continue dabrafenib and trametinib indefinitely as long as there has not been tumor progression.
11225407|NCT02367859|FG000|Participant Flow|Treatment (Dabrafenib)|Patients receive dabrafenib orally twice daily every 12 hours plus trametinib daily orally for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease is judged to be not amenable to resection will continue dabrafenib and trametinib indefinitely as long as there has not been tumor progression.
11225408|NCT02367859|OG000|Outcome|Treatment (Dabrafenib)|Patients receive dabrafenib orally twice daily every 12 hours plus trametinib daily orally for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease is judged to be not amenable to resection will continue dabrafenib and trametinib indefinitely as long as there has not been tumor progression.
11225409|NCT02367859|EG000|Reported Event|Treatment (Dabrafenib)|Patients receive dabrafenib orally twice daily every 12 hours plus trametinib daily orally for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease is judged to be not amenable to resection will continue dabrafenib and trametinib indefinitely as long as there has not been tumor progression.
11225410|NCT02367872|BG000|Baseline|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11009899|NCT01104545|EG010|Reported Event|0.75 mg MK-3614 Panel C|Participant received a single oral dose of 0.75 mg MK-3614 after an 8-hour fast
11225411|NCT02367872|BG001|Baseline|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225412|NCT02367872|BG002|Baseline|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225413|NCT02367872|BG003|Baseline|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225414|NCT02367872|BG004|Baseline|Cohort 5R: End-stage Renal Failure (Hemodialysis)|Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (dialysis on Day 1 after dosing). After Part 1 follow-up period, then the same participants received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-dialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day of follow up in Part 1.
11225415|NCT02367872|BG005|Baseline|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11341236|NCT03679741|FG000|Participant Flow|Test/Control/Control|Subjects that were randomized to receive the test lens during the first period and the control lens during both the second and third periods.
11341237|NCT03679741|FG001|Participant Flow|Control/Test/Test|Subjects that were randomized to receive the control lens during the first period and the test lens during both the second and third periods.
10884027|NCT00479674|EG000|Reported Event|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
10884028|NCT00479687|BG000|Baseline|Ph1: Supartz (Double Blind)|"SUPARTZ® 3 injections over 2 weeks~SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space."
10884029|NCT00479687|BG001|Baseline|Ph1: Phosphate Buffered Saline (Double Blind)|"Phosphate Buffered Saline 3 injections over 2 weeks~Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space."
10884030|NCT00479687|BG002|Baseline|Total|Total of all reporting groups
10884031|NCT00479687|FG000|Participant Flow|Ph1: Supartz (Double Blind)|"SUPARTZ® 3 injections over 2 weeks~SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space."
10884032|NCT00479687|FG001|Participant Flow|Ph1: Phosphate Buffered Saline (Double Blind)|"Phosphate Buffered Saline 3 injections over 2 weeks~Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space."
10884033|NCT00479687|FG002|Participant Flow|Ph2: Supartz (Open Label)|"SUPARTZ® 3 injections over 2 weeks~SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space."
10884034|NCT00479687|OG000|Outcome|Ph1: Supartz (Double Blind)|"SUPARTZ® 3 injections over 2 weeks~SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space."
10884035|NCT00479687|OG001|Outcome|Ph1: Phosphate Buffered Saline (Double Blind)|"Phosphate Buffered Saline 3 injections over 2 weeks~Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space."
11147483|NCT01857986|OG000|Outcome|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
11147484|NCT01857986|OG001|Outcome|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
11147485|NCT01857986|EG000|Reported Event|Study|
11147486|NCT01857986|EG001|Reported Event|Control|
10884036|NCT00479687|EG000|Reported Event|Supartz (Double Blind)|"SUPARTZ® 3 injections over 2 weeks~SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space."
10884037|NCT00479687|EG001|Reported Event|Phosphate Buffered Saline (Double Blind)|"Phosphate Buffered Saline 3 injections over 2 weeks~Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space."
10884038|NCT00479687|EG002|Reported Event|Supartz (Open Label)|"SUPARTZ® 3 injections over 2 weeks~SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space."
10884039|NCT00479856|BG000|Baseline|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
11009900|NCT01104545|EG011|Reported Event|0.5 mg MK-3614 Panel C|Participants received a single oral dose of 0.5 mg MK-3614 after an 8-hour fast
11147487|NCT01858194|BG000|Baseline|VT Ablation Alone|VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
11147488|NCT01858194|BG001|Baseline|Renal Sympathetic Denervation|"Catheter-based Renal Sympathetic Denervation Ablation Arm~Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation.~• After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a spiral pattern, see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion)."
11147489|NCT01858194|BG002|Baseline|Total|Total of all reporting groups
11147490|NCT01858194|FG000|Participant Flow|VT Ablation Alone|VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
11147491|NCT01858194|FG001|Participant Flow|Renal Sympathetic Denervation|"Catheter-based Renal Sympathetic Denervation Ablation Arm~Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation.~• After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a spiral pattern, see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion)."
11147492|NCT01858194|OG000|Outcome|Renal Sympathetic Denervation|"Catheter-based Renal Sympathetic Denervation Ablation Arm~Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation.~• After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a spiral pattern, see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion)."
11147493|NCT01858194|OG001|Outcome|VT Ablation Alone|VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
11147494|NCT01858194|OG000|Outcome|VT Ablation Alone|VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
11147495|NCT01858194|OG001|Outcome|Renal Sympathetic Denervation|"Catheter-based Renal Sympathetic Denervation Ablation Arm~Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation.~• After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a spiral pattern, see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion)."
11147496|NCT01858194|EG000|Reported Event|Renal Sympathetic Denervation|"Catheter-based Renal Sympathetic Denervation Ablation Arm~Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation.~• After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a spiral pattern, see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion)."
11147497|NCT01858194|EG001|Reported Event|VT Ablation Alone|"No further therapy in addition to VT ablation~VT ablation alone: Placebo arm will receive standard VT ablation using current techniques"
11147498|NCT01858363|BG000|Baseline|Paclitaxel-coated Balloon|"Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.~CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter"
11147499|NCT01858363|BG001|Baseline|Bare Balloon|"Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.~Bare Percutaneous Transluminal Angioplasty Balloon Catheter"
11147500|NCT01858363|BG002|Baseline|Total|Total of all reporting groups
11147501|NCT01858363|FG000|Participant Flow|Paclitaxel-coated Balloon|"Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.~CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter"
11147502|NCT01858363|FG001|Participant Flow|Bare Balloon|"Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.~Bare Percutaneous Transluminal Angioplasty Balloon Catheter"
11147503|NCT01858363|OG000|Outcome|Paclitaxel-coated Balloon|"Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.~CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter"
11147504|NCT01858363|OG001|Outcome|Bare Balloon|"Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.~Bare Percutaneous Transluminal Angioplasty Balloon Catheter"
11147505|NCT01858363|EG000|Reported Event|Paclitaxel-coated Balloon|"Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.~CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter"
11147506|NCT01858363|EG001|Reported Event|Bare Balloon|"Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.~Bare Percutaneous Transluminal Angioplasty Balloon Catheter"
11147507|NCT01858376|BG000|Baseline|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
11147508|NCT01858376|FG000|Participant Flow|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
11147509|NCT01858376|OG000|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
11147510|NCT01858376|EG000|Reported Event|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
11150124|NCT01875861|OG001|Outcome|Comparison|"Usual care with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components."
10884040|NCT00479856|FG000|Participant Flow|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
10884041|NCT00479856|OG000|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
10884042|NCT00479856|EG000|Reported Event|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
10884043|NCT00479882|BG000|Baseline|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
10884044|NCT00479882|BG001|Baseline|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
10884045|NCT00479882|BG002|Baseline|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
10884046|NCT00479882|BG003|Baseline|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
11147511|NCT01858389|BG000|Baseline|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
11147512|NCT01858389|BG001|Baseline|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
11147513|NCT01858389|BG002|Baseline|Total|Total of all reporting groups
11147514|NCT01858389|FG000|Participant Flow|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
10884047|NCT00479882|BG004|Baseline|Total|Total of all reporting groups
10884048|NCT00479882|FG000|Participant Flow|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
10884049|NCT00479882|FG001|Participant Flow|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
10884050|NCT00479882|FG002|Participant Flow|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
10884051|NCT00479882|FG003|Participant Flow|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
10884052|NCT00479882|OG000|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
10884053|NCT00479882|OG001|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
10884054|NCT00479882|OG002|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
11147515|NCT01858389|FG001|Participant Flow|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
11147516|NCT01858389|OG000|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
10884055|NCT00479882|OG003|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
10884056|NCT00479882|OG000|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
10884057|NCT00479882|OG001|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
10884058|NCT00479882|OG002|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
10884059|NCT00479882|OG003|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
10884060|NCT00479882|OG004|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
10884061|NCT00479882|OG005|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
10884062|NCT00479882|OG006|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
10884063|NCT00479882|OG007|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
10884064|NCT00479882|OG000|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
10884065|NCT00479882|OG001|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
10884066|NCT00479882|OG002|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
10884067|NCT00479882|OG003|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
11341238|NCT03679741|OG000|Outcome|Test|Subjects that wore the Test lens during any of the three periods during the study.
10884068|NCT00479882|EG000|Reported Event|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
10884069|NCT00479882|EG001|Reported Event|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Periods I/II
10884070|NCT00479882|EG002|Reported Event|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Period III
10884071|NCT00479882|EG003|Reported Event|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
10884072|NCT00479882|EG004|Reported Event|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
10884073|NCT00479882|EG005|Reported Event|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
10884074|NCT00479882|EG006|Reported Event|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
10884075|NCT00479882|EG007|Reported Event|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
10884076|NCT00480025|BG000|Baseline|GSK1572932 Group|Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
10884077|NCT00480025|BG001|Baseline|Placebo Group|Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
10884078|NCT00480025|BG002|Baseline|Total|Total of all reporting groups
10884079|NCT00480025|FG000|Participant Flow|GSK1572932 Group|Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
10884080|NCT00480025|FG001|Participant Flow|Placebo Group|Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
10884081|NCT00480025|OG000|Outcome|GSK1572932 Group|Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
10884082|NCT00480025|OG001|Outcome|Placebo Group|Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
10884083|NCT00480025|OG000|Outcome|GSK1572932 No-CT Group|Patients received up to 13 doses (D) of GSK1572932 ASCI, 5 Ds every 3 weeks followed by 8 Ds every 12 weeks. Patients in this sub-group consisted solely of patients who had not received adjuvant chemotherapy prior to randomization (No-CT Population).
10884084|NCT00480025|OG001|Outcome|Placebo No-CT Group|Patients received up to 13 doses (D) of placebo, 5 Ds every 3 weeks followed by 8 Ds every 12 weeks. Patients in this sub-group consisted solely of patients who had not received adjuvant chemotherapy prior to randomization (No-CT Population).
10884085|NCT00480025|OG000|Outcome|GSK1572932 CT Group|Patients received up to 13 doses (D) of GSK1572932, 5 Ds every 3 weeks followed by 8 Ds every 12 weeks. Patients in this sub-group consisted solely of patients who had received adjuvant chemotherapy prior to randomization (CT Population).
10884086|NCT00480025|OG001|Outcome|Placebo CT Group|Patients received up to 13 doses (D) of placebo, 5 Ds every 3 weeks followed by 8 Ds every 12 weeks. Patients in this sub-group consisted solely of patients who had received adjuvant chemotherapy prior to randomization (CT Population).
10884087|NCT00480025|OG000|Outcome|GSK1572932 Group|Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
10884088|NCT00480025|OG001|Outcome|Placebo Group|Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks
10884089|NCT00480025|EG000|Reported Event|GSK1572932 Group|Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
10884090|NCT00480025|EG001|Reported Event|Placebo Group|Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
10884091|NCT00480077|BG000|Baseline|Access Arm|"HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report~Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass"
11341239|NCT03679741|OG001|Outcome|Control|Subjects that wore the Control lens during any of the three periods during the study.
10884092|NCT00480077|BG001|Baseline|Control Arm|"HF subjects managed with standard clinical assessment~Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass"
10884093|NCT00480077|BG002|Baseline|Total|Total of all reporting groups
11225416|NCT02367872|BG006|Baseline|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225417|NCT02367872|BG007|Baseline|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225418|NCT02367872|BG008|Baseline|Total|Total of all reporting groups
11225419|NCT02367872|FG000|Participant Flow|Cohort 1R: Normal Renal Function|Participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2]) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225420|NCT02367872|FG001|Participant Flow|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60, less than [<] 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225421|NCT02367872|FG002|Participant Flow|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225422|NCT02367872|FG003|Participant Flow|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225423|NCT02367872|FG004|Participant Flow|Cohort 5R: End-stage Renal Failure (Hemodialysis)|Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (dialysis on Day 1 after dosing). After Part 1 follow-up period, then the same participants received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-dialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day of follow up in Part 1.
11225424|NCT02367872|FG005|Participant Flow|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225425|NCT02367872|FG006|Participant Flow|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time [PT] or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
10884094|NCT00480077|FG000|Participant Flow|Access Arm|"HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report~Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) : OptiVol® Fluid status Monitoring with Cardiac Compass"
11225426|NCT02367872|FG007|Participant Flow|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225427|NCT02367872|OG000|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11341240|NCT03679741|EG000|Reported Event|Test|Subjects that wore the Test lens during any of the 3 period during the study.
10884095|NCT00480077|FG001|Participant Flow|Control Arm|"HF subjects managed with standard clinical assessment~Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) : OptiVol® Fluid status Monitoring with Cardiac Compass"
10884096|NCT00480077|OG000|Outcome|Access Arm|"HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report~Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass"
10884097|NCT00480077|OG001|Outcome|Control Arm|"HF subjects managed with standard clinical assessment~Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass"
10884098|NCT00480077|EG000|Reported Event|Access Arm|"HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report~Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass"
10884099|NCT00480077|EG001|Reported Event|Control Arm|"HF subjects managed with standard clinical assessment~Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass"
10884100|NCT00480324|BG000|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
10884101|NCT00480324|BG001|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
10884102|NCT00480324|BG002|Baseline|Total|Total of all reporting groups
10884103|NCT00480324|FG000|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
10884104|NCT00480324|FG001|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
10884105|NCT00480324|OG000|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
10884106|NCT00480324|OG001|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
10884107|NCT00480324|EG000|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
10884108|NCT00480324|EG001|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
10884109|NCT00480441|BG000|Baseline|Non-Randomized Participants|These were participants who consented but were excluded prior to neuroimaging and randomization because they did not meet study criteria.
10884110|NCT00480441|BG001|Baseline|Placebo/Dronabinol|This arm represents participants who were either given the placebo or dronabinol following the neuroimaging procedure. There was insufficient data to analyze the dronabinol and placebo groups separately due to an inability to meet statistical power considerations. Thus, for the results, the placebo and dronabinol subjects were combined into one group.
11009901|NCT01104545|EG012|Reported Event|Placebo Panel C|Participant received a single oral dose of placebo for MK-3614 after an 8-hour fast
11147517|NCT01858389|OG001|Outcome|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
11147518|NCT01858389|OG000|Outcome|Dacomitinib, 45 mg|Participants received a 1-week lead-in cycle of dacomitinib, 45 mg, every 12 hours for 6 doses on Days 1-4.
11147519|NCT01858389|OG000|Outcome|Dacomitinib, 45/60 mg|Participants received a 1-week lead-in cycle of dacomitinib, 45 mg, every 12 hours for 6 doses on Days 1-4. Following the lead-in cycle, all participants received intermittent dacomitinib, 60 mg, administered every 12 hours for 6 doses at the beginning of each 2-week cycle.
11147520|NCT01858389|EG000|Reported Event|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
11147521|NCT01858389|EG001|Reported Event|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
11147522|NCT01858428|BG000|Baseline|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
11147523|NCT01858428|BG001|Baseline|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
11147524|NCT01858428|BG002|Baseline|Total|Total of all reporting groups
11147525|NCT01858428|FG000|Participant Flow|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
11147526|NCT01858428|FG001|Participant Flow|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
11147527|NCT01858428|OG000|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
11147528|NCT01858428|OG001|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
11147529|NCT01858428|EG000|Reported Event|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
11147530|NCT01858428|EG001|Reported Event|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
11147531|NCT01858532|BG000|Baseline|Intent-to-Treat (ITT) Responder Atrasentan|Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
11341241|NCT03679741|EG001|Reported Event|Control|Subjects that wore the Controllens during any of the 3 period during the study.
10884111|NCT00480441|BG002|Baseline|Total|Total of all reporting groups
10884112|NCT00480441|FG000|Participant Flow|All Screened Participants|All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.
10884113|NCT00480441|FG001|Participant Flow|Placebo 10mg QID|All participants who were eligible for randomization, were randomized to receive either the active drug, dronabinol 10mg per dose up to 4 times per day or placebo up to 4 times per day.
10884114|NCT00480441|FG002|Participant Flow|Dronabinol 10mg QID|All participants who were eligible for randomization, were randomized to receive either the active drug, dronabinol 10mg per dose up to 4 times per day or placebo up to 4 times per day.
10884115|NCT00480441|OG000|Outcome|All Participants|All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.
10884116|NCT00480441|OG000|Outcome|Non-Randomized Participants|
10884117|NCT00480441|OG001|Outcome|Placebo/Dronabinol|This arm represents the participants who, following neuroimaging procedure and randomization, were given either placebo or Dronabinol
10884118|NCT00480441|EG000|Reported Event|Non-Randomized Participants|37 consented subjects were determined to be ineligible for randomization.
10884119|NCT00480441|EG001|Reported Event|Placebo/Dronabinol|This arm represents participants who were either given the placebo or dronabinol following the neuroimaging procedure.
11147532|NCT01858532|BG001|Baseline|Intent-to-Treat (ITT) Responder Placebo|Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
11147533|NCT01858532|BG002|Baseline|Intent-to-Treat (ITT) Non-responder Atrasentan|Participants who achieved < 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
11147534|NCT01858532|BG003|Baseline|Intent-to-Treat (ITT) Non-responder Placebo|Participants who achieved < 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
11147535|NCT01858532|BG004|Baseline|Total|Total of all reporting groups
11147536|NCT01858532|FG000|Participant Flow|Intent-to-Treat (ITT) Responder Atrasentan|Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
11147537|NCT01858532|FG001|Participant Flow|Intent-to-Treat (ITT) Responder Placebo|Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
11147538|NCT01858532|FG002|Participant Flow|Intent-to-Treat (ITT) Non-responder Atrasentan|Participants who achieved < 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
10884120|NCT00480493|BG000|Baseline|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
11147539|NCT01858532|FG003|Participant Flow|Intent-to-Treat (ITT) Non-responder Placebo|Participants who achieved < 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
11147540|NCT01858532|OG000|Outcome|Intent-to-Treat (ITT) Responder Atrasentan|Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
11147541|NCT01858532|OG001|Outcome|Intent-to-Treat (ITT) Responder Placebo|Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
11147542|NCT01858532|OG000|Outcome|Intent-to-Treat (ITT) Atrasentan|All randomized participants who entered the Double-Blind Treatment Period and were randomized to receive atrasentan
11147543|NCT01858532|OG001|Outcome|Intent-to-Treat Placebo|All randomized participants who entered the Double-Blind Treatment Period and were randomized to receive placebo
11147544|NCT01858532|OG001|Outcome|Intent-to-Treat (ITT) Responder Placebo|Intent-to-Treat (ITT) Responder Placebo: Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
11147545|NCT01858532|EG000|Reported Event|Enrichment Atrasentan|Participants who received at least one dose of atrasentan, including both Enrichment and Double-Blind Treatment Periods
11147546|NCT01858532|EG001|Reported Event|Double-Blind Atrasentan|All participants who received at least one dose of atrasentan during the Double-Blind Treatment Period
11147547|NCT01858532|EG002|Reported Event|Double-Blind Placebo|All participants who received at least one dose of placebo during the Double-Blind Treatment Period
11147548|NCT01858545|BG000|Baseline|Experimental|"MatriStem MicroMatrix and MatriStem Wound Matrix~MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix"
11147549|NCT01858545|BG001|Baseline|Comparator|"Cellular Dermal Replacement Tissue~Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue"
11147550|NCT01858545|BG002|Baseline|Total|Total of all reporting groups
11147551|NCT01858545|FG000|Participant Flow|Experimental|"MatriStem MicroMatrix and MatriStem Wound Matrix~MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix"
11147552|NCT01858545|FG001|Participant Flow|Comparator|"Cellular Dermal Replacement Tissue~Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue"
11147553|NCT01858545|OG000|Outcome|Experimental|"MatriStem MicroMatrix and MatriStem Wound Matrix~MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix"
11147554|NCT01858545|OG001|Outcome|Comparator|"Cellular Dermal Replacement Tissue~Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue"
11147555|NCT01858545|EG000|Reported Event|Experimental|"MatriStem MicroMatrix and MatriStem Wound Matrix~MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix"
11147556|NCT01858545|EG001|Reported Event|Comparator|"Cellular Dermal Replacement Tissue~Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue"
11147557|NCT01858558|BG000|Baseline|aMIL Arm|"Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)~aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide."
11147558|NCT01858558|BG001|Baseline|No aMIL|"Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)~No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide."
11147559|NCT01858558|BG002|Baseline|Total|Total of all reporting groups
11147560|NCT01858558|FG000|Participant Flow|aMIL Arm|"Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)~aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide."
11147561|NCT01858558|FG001|Participant Flow|No aMIL|"Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)~No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide."
11147562|NCT01858558|OG000|Outcome|aMIL Arm|"Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)~aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide."
10884121|NCT00480493|BG001|Baseline|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
10884122|NCT00480493|BG002|Baseline|Total|Total of all reporting groups
10884123|NCT00480493|FG000|Participant Flow|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
11225428|NCT02367872|OG001|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225429|NCT02367872|OG002|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225430|NCT02367872|OG003|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225431|NCT02367872|OG004|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
11225432|NCT02367872|OG005|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
11225433|NCT02367872|OG006|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225434|NCT02367872|OG007|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225435|NCT02367872|OG008|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225436|NCT02367872|OG004|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225437|NCT02367872|OG005|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225438|NCT02367872|OG006|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225439|NCT02367872|OG005|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
11225440|NCT02367872|OG006|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225441|NCT02367872|OG007|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225442|NCT02367872|OG000|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
10884124|NCT00480493|FG001|Participant Flow|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
10884125|NCT00480493|OG000|Outcome|Parent Contact Control Arm|Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.
10884126|NCT00480493|OG001|Outcome|Parent Mentor Experimental Arm|Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
10884127|NCT00480493|OG000|Outcome|Parent Contact Control Arm|
10884128|NCT00480493|OG001|Outcome|Parent Mentor Experimental Arm|
10884129|NCT00480493|EG000|Reported Event|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
10884130|NCT00480493|EG001|Reported Event|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
11147563|NCT01858558|OG001|Outcome|No aMIL|"Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)~No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide."
11147564|NCT01858558|EG000|Reported Event|aMIL Arm|"Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)~aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide."
11147565|NCT01858558|EG001|Reported Event|No aMIL|"Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)~No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide."
11147566|NCT01858636|BG000|Baseline|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6F and 8F devices: These devices are used for the vascular closure procedure
11147567|NCT01858636|FG000|Participant Flow|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6 French (6F) and 8 French (8F) devices: These devices are used for the vascular closure procedure
11147568|NCT01858636|OG000|Outcome|Deployed Subjects|Percentage of subjects who experienced a major vascular complication during 30-days post procedure.
11147569|NCT01858636|OG000|Outcome|Deployed Subjects|Subjects with Angio-Seal deployed
11147570|NCT01858636|EG000|Reported Event|Deployed Subjects|Adverse Events (AEs) are provided for all subjects that underwent a study device deployment.
11147571|NCT01858701|BG000|Baseline|Overall|Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment.
11147572|NCT01858701|FG000|Participant Flow|AO for Astig / Biofinity Toric|Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.
11147573|NCT01858701|FG001|Participant Flow|Biofinity Toric / AO for Astig|Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.
11147574|NCT01858701|OG000|Outcome|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
11147575|NCT01858701|OG001|Outcome|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
11147576|NCT01858701|EG000|Reported Event|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
11147577|NCT01858701|EG001|Reported Event|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
10884131|NCT00480532|BG000|Baseline|Placebo (Treatment)|Placebo (for treatment portion of the study)
11147578|NCT01858753|BG000|Baseline|Autologous Fibroblasts|"Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.~Autologous fibroblasts"
11147579|NCT01858753|BG001|Baseline|Sterile Saline|"Sterile saline will be injected into the scar to be evaluated.~Autologous fibroblasts~placebo sterile saline"
10884132|NCT00480532|BG001|Baseline|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
11147580|NCT01858753|BG002|Baseline|Total|Total of all reporting groups
10884133|NCT00480532|BG002|Baseline|Placebo (Prevention)|Placebo for prevention portion of the study
10884134|NCT00480532|BG003|Baseline|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
10884135|NCT00480532|BG004|Baseline|Total|Total of all reporting groups
10884136|NCT00480532|FG000|Participant Flow|Placebo (Treatment)|Placebo (for treatment portion of the study)
10884137|NCT00480532|FG001|Participant Flow|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
11147581|NCT01858753|FG000|Participant Flow|Autologous Fibroblasts|"Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.~Autologous fibroblasts"
11147582|NCT01858753|FG001|Participant Flow|Sterile Saline|"Sterile saline will be injected into the scar to be evaluated.~Autologous fibroblasts~placebo sterile saline"
11147583|NCT01858753|OG000|Outcome|Autologous Fibroblasts|"Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.~Autologous fibroblasts"
11147584|NCT01858753|OG001|Outcome|Sterile Saline|"Sterile saline will be injected into the scar to be evaluated.~Autologous fibroblasts~placebo sterile saline"
11147585|NCT01858753|EG000|Reported Event|Autologous Fibroblasts|"Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.~Autologous fibroblasts"
11147586|NCT01858753|EG001|Reported Event|Sterile Saline|"Sterile saline will be injected into the scar to be evaluated.~Autologous fibroblasts~placebo sterile saline"
11147587|NCT01858766|BG000|Baseline|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
11147588|NCT01858766|BG001|Baseline|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
11147589|NCT01858766|BG002|Baseline|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
11147590|NCT01858766|BG003|Baseline|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
11147591|NCT01858766|BG004|Baseline|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
11147592|NCT01858766|BG005|Baseline|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
11147593|NCT01858766|BG006|Baseline|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
11147594|NCT01858766|BG007|Baseline|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
10884138|NCT00480532|FG002|Participant Flow|Placebo (Prevention)|Placebo for prevention portion of the study
10884139|NCT00480532|FG003|Participant Flow|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
10884140|NCT00480532|OG000|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
10884141|NCT00480532|OG001|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
10884142|NCT00480532|OG002|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
10884143|NCT00480532|OG003|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
10884144|NCT00480532|EG000|Reported Event|Placebo (Treatment)|Placebo (for treatment portion of the study)
10884145|NCT00480532|EG001|Reported Event|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
11147595|NCT01858766|BG008|Baseline|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
11147596|NCT01858766|BG009|Baseline|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
11147597|NCT01858766|BG010|Baseline|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
11147598|NCT01858766|BG011|Baseline|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
11147599|NCT01858766|BG012|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
11147600|NCT01858766|BG013|Baseline|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
11147601|NCT01858766|BG014|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
10884146|NCT00480532|EG002|Reported Event|Placebo (Prevention)|Placebo for prevention portion of the study
11147602|NCT01858766|BG015|Baseline|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
11147603|NCT01858766|BG016|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
10884147|NCT00480532|EG003|Reported Event|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
10884148|NCT00480636|BG000|Baseline|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
10884149|NCT00480636|FG000|Participant Flow|Dalteparin|Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
10884150|NCT00480636|OG000|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
10884151|NCT00480636|EG000|Reported Event|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
10884152|NCT00480740|BG000|Baseline|Normal Physiology|
10884153|NCT00480740|BG001|Baseline|Cardiac Transplant|
10884154|NCT00480740|BG002|Baseline|Fontan Physiology|
10884155|NCT00480740|BG003|Baseline|Total|Total of all reporting groups
10884156|NCT00480740|FG000|Participant Flow|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
10884157|NCT00480740|FG001|Participant Flow|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
10884158|NCT00480740|FG002|Participant Flow|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
10884159|NCT00480740|OG000|Outcome|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
10884160|NCT00480740|OG001|Outcome|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
10884161|NCT00480740|OG002|Outcome|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
10884162|NCT00480740|EG000|Reported Event|Cardiac Transplant|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
11147604|NCT01858766|BG017|Baseline|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
11147605|NCT01858766|BG018|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
11147606|NCT01858766|BG019|Baseline|Total|Total of all reporting groups
11147607|NCT01858766|FG000|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT1)|Sofosbuvir (SOF) 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 1)
11147608|NCT01858766|FG001|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
11147609|NCT01858766|FG002|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
11147610|NCT01858766|FG003|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
11147611|NCT01858766|FG004|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
11147612|NCT01858766|FG005|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
11147613|NCT01858766|FG006|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
11147614|NCT01858766|FG007|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
11147615|NCT01858766|FG008|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
10884163|NCT00480740|EG001|Reported Event|Fontan Procedure|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
10884164|NCT00480740|EG002|Reported Event|Normal Physiology|"control group~Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization"
10884165|NCT00480779|BG000|Baseline|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
10884166|NCT00480779|BG001|Baseline|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
10884167|NCT00480779|BG002|Baseline|Total|Total of all reporting groups
10884168|NCT00480779|FG000|Participant Flow|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
10884169|NCT00480779|FG001|Participant Flow|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
11147616|NCT01858766|FG009|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
11147617|NCT01858766|FG010|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
11147618|NCT01858766|FG011|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
11147619|NCT01858766|FG012|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
11147620|NCT01858766|FG013|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
11147621|NCT01858766|FG014|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
11147622|NCT01858766|FG015|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
11147623|NCT01858766|FG016|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
11147624|NCT01858766|FG017|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
11147625|NCT01858766|FG018|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
11147626|NCT01858766|OG000|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
10884170|NCT00480779|OG000|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
11147627|NCT01858766|OG001|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
11147628|NCT01858766|OG002|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
11147629|NCT01858766|OG003|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
11147630|NCT01858766|OG004|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
11147631|NCT01858766|OG005|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
10884171|NCT00480779|OG001|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
10884172|NCT00480779|EG000|Reported Event|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
10884173|NCT00480779|EG001|Reported Event|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD:The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
10884174|NCT00480857|BG000|Baseline|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
10884175|NCT00480857|FG000|Participant Flow|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
11147632|NCT01858766|OG006|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
11147633|NCT01858766|OG007|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
11147634|NCT01858766|OG008|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
11147635|NCT01858766|OG009|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
11147636|NCT01858766|OG010|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
11147637|NCT01858766|OG011|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
11147638|NCT01858766|OG012|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
11147639|NCT01858766|OG013|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
11147640|NCT01858766|OG014|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
11147641|NCT01858766|OG015|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
11147642|NCT01858766|OG016|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
11147643|NCT01858766|OG017|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
11147644|NCT01858766|OG018|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
11147645|NCT01858766|OG000|Outcome|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
11147646|NCT01858766|OG001|Outcome|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
11147647|NCT01858766|OG002|Outcome|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
11147648|NCT01858766|OG003|Outcome|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
11147649|NCT01858766|OG004|Outcome|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
11147650|NCT01858766|OG005|Outcome|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
11147651|NCT01858766|EG000|Reported Event|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
11147652|NCT01858766|EG001|Reported Event|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
11147653|NCT01858766|EG002|Reported Event|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
10884176|NCT00480857|OG000|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
10884177|NCT00480857|EG000|Reported Event|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
10884178|NCT00480987|BG000|Baseline|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
10884179|NCT00480987|FG000|Participant Flow|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
10884180|NCT00480987|OG000|Outcome|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
10884181|NCT00480987|EG000|Reported Event|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
10884182|NCT00481065|BG000|Baseline|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884183|NCT00481065|BG001|Baseline|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884184|NCT00481065|BG002|Baseline|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884185|NCT00481065|BG003|Baseline|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884186|NCT00481065|BG004|Baseline|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
10884187|NCT00481065|BG005|Baseline|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884188|NCT00481065|BG006|Baseline|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884189|NCT00481065|BG007|Baseline|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
11147654|NCT01858766|EG003|Reported Event|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
11147655|NCT01858766|EG004|Reported Event|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
11147656|NCT01858766|EG005|Reported Event|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
10884190|NCT00481065|BG008|Baseline|Total|Total of all reporting groups
10884191|NCT00481065|FG000|Participant Flow|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
11225443|NCT02367872|EG000|Reported Event|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
10884192|NCT00481065|FG001|Participant Flow|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884193|NCT00481065|FG002|Participant Flow|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884194|NCT00481065|FG003|Participant Flow|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884195|NCT00481065|FG004|Participant Flow|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
10884196|NCT00481065|FG005|Participant Flow|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884197|NCT00481065|FG006|Participant Flow|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884198|NCT00481065|FG007|Participant Flow|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884199|NCT00481065|OG000|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884200|NCT00481065|OG001|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884201|NCT00481065|OG002|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884202|NCT00481065|OG003|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
11225444|NCT02367872|EG001|Reported Event|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
10884203|NCT00481065|OG004|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
10884204|NCT00481065|OG005|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884205|NCT00481065|OG006|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884206|NCT00481065|OG007|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884207|NCT00481065|OG000|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884208|NCT00481065|OG001|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
10884209|NCT00481065|EG000|Reported Event|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884210|NCT00481065|EG001|Reported Event|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884211|NCT00481065|EG002|Reported Event|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884212|NCT00481065|EG003|Reported Event|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884213|NCT00481065|EG004|Reported Event|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
10884214|NCT00481065|EG005|Reported Event|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884215|NCT00481065|EG006|Reported Event|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884216|NCT00481065|EG007|Reported Event|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
10884217|NCT00481078|BG000|Baseline|Arm 1|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
10884218|NCT00481078|BG001|Baseline|Arm 2|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
10884219|NCT00481078|BG002|Baseline|Total|Total of all reporting groups
10884220|NCT00481078|FG000|Participant Flow|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
10884221|NCT00481078|FG001|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
10884222|NCT00481078|OG000|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
10884223|NCT00481078|OG001|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
10884224|NCT00481078|EG000|Reported Event|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
11147657|NCT01859013|BG000|Baseline|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.~Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
11147658|NCT01859013|BG001|Baseline|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.~Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
11147659|NCT01859013|BG002|Baseline|Total|Total of all reporting groups
11225445|NCT02367872|EG002|Reported Event|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
10884225|NCT00481078|EG001|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
10884226|NCT00481195|BG000|Baseline|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
10884227|NCT00481195|BG001|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
10884228|NCT00481195|BG002|Baseline|Total|Total of all reporting groups
10884229|NCT00481195|FG000|Participant Flow|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
10884230|NCT00481195|FG001|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
10884231|NCT00481195|OG000|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
10884232|NCT00481195|OG001|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
10884233|NCT00481195|EG000|Reported Event|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
10884234|NCT00481195|EG001|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
10884235|NCT00481247|BG000|Baseline|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
10884236|NCT00481247|BG001|Baseline|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
10884237|NCT00481247|BG002|Baseline|Total|Total of all reporting groups
10884238|NCT00481247|FG000|Participant Flow|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
10884239|NCT00481247|FG001|Participant Flow|Imatinib|Tablets, oral, imatinib 400mg once daily (QD)
11225446|NCT02367872|EG003|Reported Event|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
10884240|NCT00481247|OG000|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
10884241|NCT00481247|OG001|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
10884242|NCT00481247|EG000|Reported Event|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
10884243|NCT00481247|EG001|Reported Event|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
10884244|NCT00481351|BG000|Baseline|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
10884245|NCT00481351|BG001|Baseline|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
10884246|NCT00481351|BG002|Baseline|Total|Total of all reporting groups
10884247|NCT00481351|FG000|Participant Flow|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
10884248|NCT00481351|FG001|Participant Flow|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
10884249|NCT00481351|OG000|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
10884250|NCT00481351|OG001|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
10884251|NCT00481351|EG000|Reported Event|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
10884252|NCT00481351|EG001|Reported Event|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
10884253|NCT00481507|BG000|Baseline|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
10884254|NCT00481507|BG001|Baseline|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
10884255|NCT00481507|BG002|Baseline|Total|Total of all reporting groups
10884256|NCT00481507|FG000|Participant Flow|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
10884257|NCT00481507|FG001|Participant Flow|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
11147660|NCT01859013|FG000|Participant Flow|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.~Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
11147661|NCT01859013|FG001|Participant Flow|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.~Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
10884258|NCT00481507|OG000|Outcome|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
10884259|NCT00481507|OG001|Outcome|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
10884260|NCT00481507|EG000|Reported Event|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
10884261|NCT00481507|EG001|Reported Event|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
10884262|NCT00481676|BG000|Baseline|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
10884263|NCT00481676|BG001|Baseline|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
10884264|NCT00481676|BG002|Baseline|Total|Total of all reporting groups
10884265|NCT00481676|FG000|Participant Flow|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
10884266|NCT00481676|FG001|Participant Flow|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
10884267|NCT00481676|OG000|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
10884268|NCT00481676|OG001|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
10884269|NCT00481676|EG000|Reported Event|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
10884270|NCT00481676|EG001|Reported Event|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
10884271|NCT00481767|BG000|Baseline|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
10884272|NCT00481767|BG001|Baseline|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
10884273|NCT00481767|BG002|Baseline|Total|Total of all reporting groups
10884274|NCT00481767|FG000|Participant Flow|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
10884275|NCT00481767|FG001|Participant Flow|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
10884276|NCT00481767|OG000|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
10884277|NCT00481767|OG001|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
10884278|NCT00481767|EG000|Reported Event|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
10884279|NCT00481767|EG001|Reported Event|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
10884280|NCT00481832|BG000|Baseline|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
10884281|NCT00481832|FG000|Participant Flow|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
10884282|NCT00481832|OG000|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
10884283|NCT00481832|EG000|Reported Event|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
10884284|NCT00481845|BG000|Baseline|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
10884285|NCT00481845|BG001|Baseline|Anastrozole|Anastrozole as neoadjuvant therapy
10884286|NCT00481845|BG002|Baseline|Total|Total of all reporting groups
10884287|NCT00481845|FG000|Participant Flow|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
11147662|NCT01859013|OG000|Outcome|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.~Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
11147663|NCT01859013|OG001|Outcome|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.~Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
11150125|NCT01875861|EG000|Reported Event|Intervention|"Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.~Evidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase."
10849139|NCT00294554|BG000|Baseline|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
10849140|NCT00294554|BG001|Baseline|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
10849141|NCT00294554|BG002|Baseline|Total|Total of all reporting groups
10849142|NCT00294554|FG000|Participant Flow|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
10849143|NCT00294554|FG001|Participant Flow|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
10849144|NCT00294554|OG000|Outcome|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
10849145|NCT00294554|OG001|Outcome|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
10849146|NCT00294554|EG000|Reported Event|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
10849147|NCT00294554|EG001|Reported Event|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
10849148|NCT00294632|BG000|Baseline|Phase 1: Lenalidomide + Rituximab|Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10849149|NCT00294632|BG001|Baseline|Phase II: Lenalidomide 20 mg + Rituximab|Lenalidomide MTD Dose 20 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10849150|NCT00294632|BG002|Baseline|Total|Total of all reporting groups
10849151|NCT00294632|FG000|Participant Flow|Phase I: Lenalidomide + Rituximab|Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10849152|NCT00294632|FG001|Participant Flow|Phase II: Lenalidomide 20 mg + Rituximab|Lenalidomide MTD Dose 20 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10849153|NCT00294632|OG000|Outcome|Phase I: Lenalidomide + Rituximab|Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10849154|NCT00294632|OG000|Outcome|Lenalidomide 20 mg + Rituximab|Lenalidomide MTD Dose 20 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10884288|NCT00481845|FG001|Participant Flow|Anastrozole|Anastrozole as neoadjuvant therapy
10884289|NCT00481845|OG000|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
10884290|NCT00481845|OG001|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
10884291|NCT00481845|EG000|Reported Event|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
10884292|NCT00481845|EG001|Reported Event|Anastrozole|Anastrozole as neoadjuvant therapy
10884293|NCT00481871|BG000|Baseline|Phase 1 - Group A|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
10884294|NCT00481871|BG001|Baseline|Phase 1 - Group B|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
10884295|NCT00481871|BG002|Baseline|Phase 1 - Group C|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
10884296|NCT00481871|BG003|Baseline|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
10884297|NCT00481871|BG004|Baseline|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
10884298|NCT00481871|BG005|Baseline|Total|Total of all reporting groups
10884299|NCT00481871|FG000|Participant Flow|Phase 1 Group A - Dose Finding|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
10884300|NCT00481871|FG001|Participant Flow|Phase 1 Group B - Dose Finding|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
10884301|NCT00481871|FG002|Participant Flow|Phase 1 Group C - Dose Finding|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
10884302|NCT00481871|FG003|Participant Flow|Phase 2 Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
10884303|NCT00481871|FG004|Participant Flow|Phase 2 Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
10884304|NCT00481871|OG000|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
10884305|NCT00481871|OG001|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
10884306|NCT00481871|OG002|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
10884307|NCT00481871|EG000|Reported Event|Phase 1|Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study
10884308|NCT00481871|EG001|Reported Event|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
10884309|NCT00481871|EG002|Reported Event|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
10884310|NCT00481988|BG000|Baseline|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
10884311|NCT00481988|BG001|Baseline|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
10884312|NCT00481988|BG002|Baseline|Total|Total of all reporting groups
10884313|NCT00481988|FG000|Participant Flow|Iomed II Phoresor Transcranial Direct Current Stimulation|The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.
10884314|NCT00481988|FG001|Participant Flow|Sham Iomed II Phoresor Transcranial Direct Current Stimulation|The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
11147664|NCT01859013|EG000|Reported Event|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.~Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
11147665|NCT01859013|EG001|Reported Event|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.~Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
11147666|NCT01859078|BG000|Baseline|Baricitinib + Digoxin|"Digoxin - 0.5 mg administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 16.~Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16."
11147667|NCT01859078|FG000|Participant Flow|Baricitinib + Digoxin|"Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.~Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16."
11147668|NCT01859078|OG000|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
11147669|NCT01859078|OG001|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
11147670|NCT01859078|EG000|Reported Event|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
11147671|NCT01859078|EG001|Reported Event|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
11147672|NCT01859143|BG000|Baseline|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
11147673|NCT01859143|BG001|Baseline|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
11147674|NCT01859143|BG002|Baseline|Total|Total of all reporting groups
11147675|NCT01859143|FG000|Participant Flow|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
11147676|NCT01859143|FG001|Participant Flow|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
11147677|NCT01859143|OG000|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
11147678|NCT01859143|OG001|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
11147679|NCT01859143|OG000|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
11147680|NCT01859143|EG000|Reported Event|TRIVALENT VACCINE|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
11147681|NCT01859143|EG001|Reported Event|PLACEBO|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
11147682|NCT01859195|BG000|Baseline|Focus Groups|Focus Groups
11147683|NCT01859195|BG001|Baseline|Cognitive Interviews|Cognitive Interviews
11147684|NCT01859195|BG002|Baseline|Total|Total of all reporting groups
11147685|NCT01859195|FG000|Participant Flow|Focus Group Stage|~20-24 participants, to comprise 3-6 focus groups
11147686|NCT01859195|FG001|Participant Flow|Cognitive Interview Stage|~12-16 participants in individual cognitive interviews
11147687|NCT01859195|OG000|Outcome|Number of Participants: Focus Group|Number of participants in focus group stage
11147688|NCT01859195|OG001|Outcome|Number of Participants: Cognitive Interviews|Number of participants in cognitive interview stage
11147689|NCT01859195|OG000|Outcome|Number of Participants: Focus Groups|number of participants who completed focus group stage
11147690|NCT01859195|OG001|Outcome|Number of Participants: Cognitive Interviews|number of participants who completed cognitive interview stage
11147691|NCT01859195|EG000|Reported Event|Focus Groups|
10849155|NCT00294632|OG000|Outcome|Lenalidomide + Rituximab|Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10849156|NCT00294632|EG000|Reported Event|Phase I: Lenalidomide + Rituximab|Lenalidomide Starting Dose 10 mg, 15 mg, 20 mg or 25 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10849157|NCT00294632|EG001|Reported Event|Phase II: Lenalidomide|Lenalidomide MTD Dose 20 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
10849158|NCT00294645|BG000|Baseline|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
10849159|NCT00294645|BG001|Baseline|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
10849160|NCT00294645|BG002|Baseline|Total|Total of all reporting groups
10849161|NCT00294645|FG000|Participant Flow|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
10849162|NCT00294645|FG001|Participant Flow|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
10849163|NCT00294645|OG000|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
10849164|NCT00294645|OG001|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
10849165|NCT00294645|EG000|Reported Event|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
11147692|NCT01859195|EG001|Reported Event|Cognitive Interviews|
10884315|NCT00481988|OG000|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
10884316|NCT00481988|OG001|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
10884317|NCT00481988|EG000|Reported Event|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
10884318|NCT00481988|EG001|Reported Event|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
10884319|NCT00482001|BG000|Baseline|Donepezil|donepezil: donepezil 5mg, once daily for 2 weeks
10884320|NCT00482001|BG001|Baseline|Placebo|Placebo (cornstarch): 1 capsule daily for 2 weeks
10884321|NCT00482001|BG002|Baseline|Total|Total of all reporting groups
10884322|NCT00482001|FG000|Participant Flow|Donepezil|donepezil: donepezil 5mg, once daily for 2 weeks
10884323|NCT00482001|FG001|Participant Flow|Placebo|Placebo (cornstarch): 1 capsule daily for 2 weeks
10884324|NCT00482001|OG000|Outcome|Donepezil|donepezil: donepezil 5mg, once daily for 2 weeks
10884325|NCT00482001|OG001|Outcome|Placebo|Placebo (cornstarch): 1 capsule daily for 2 weeks
10884326|NCT00482001|OG000|Outcome|Donepezil|"donepezil, capsule, 5mg daily once daily for 14 days~donepezil"
10884327|NCT00482001|OG001|Outcome|Placebo|"placebo (cornstarch), capsule, once daily for 14 days~Placebo (cornstarch)"
10884328|NCT00482001|EG000|Reported Event|Donepezil|donepezil 5mg, one capsule daily for 14 days
10884329|NCT00482001|EG001|Reported Event|Placebo|Placebo (cornstarch), 1 capsule daily for 14 days
10884330|NCT00482014|BG000|Baseline|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
10884331|NCT00482014|BG001|Baseline|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
10884332|NCT00482014|BG002|Baseline|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
10884333|NCT00482014|BG003|Baseline|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
10884334|NCT00482014|BG004|Baseline|Total|Total of all reporting groups
10884335|NCT00482014|FG000|Participant Flow|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
10884336|NCT00482014|FG001|Participant Flow|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
10884337|NCT00482014|FG002|Participant Flow|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
10884338|NCT00482014|FG003|Participant Flow|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
10884339|NCT00482014|OG000|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
11147693|NCT01859247|BG000|Baseline|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
10884340|NCT00482014|OG000|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
10884341|NCT00482014|OG001|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
10884342|NCT00482014|OG000|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
10884343|NCT00482014|OG001|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
11147694|NCT01859247|BG001|Baseline|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
11147695|NCT01859247|BG002|Baseline|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
11147696|NCT01859247|BG003|Baseline|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
11147697|NCT01859247|BG004|Baseline|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
10884344|NCT00482014|OG000|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
11147698|NCT01859247|BG005|Baseline|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
11147699|NCT01859247|BG006|Baseline|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
11147700|NCT01859247|BG007|Baseline|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
11147701|NCT01859247|BG008|Baseline|Total|Total of all reporting groups
11147702|NCT01859247|FG000|Participant Flow|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
11147703|NCT01859247|FG001|Participant Flow|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
11147704|NCT01859247|FG002|Participant Flow|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
11147705|NCT01859247|FG003|Participant Flow|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
11147706|NCT01859247|FG004|Participant Flow|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
11147707|NCT01859247|FG005|Participant Flow|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
11147708|NCT01859247|FG006|Participant Flow|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
11147709|NCT01859247|FG007|Participant Flow|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
11147710|NCT01859247|OG000|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
11147711|NCT01859247|OG001|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
11147712|NCT01859247|OG002|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
10884345|NCT00482014|EG000|Reported Event|Phase 1: Pemetrexed + Carboplatin|"500 milligrams/meter squared (mg/m²) pemetrexed (pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
10884346|NCT00482014|EG001|Reported Event|Phase 1: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
10884347|NCT00482014|EG002|Reported Event|Phase 2: Pemetrexed + Carboplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
10884348|NCT00482014|EG003|Reported Event|Phase 2: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
10884349|NCT00482053|BG000|Baseline|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
11147713|NCT01859247|OG003|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
11147714|NCT01859247|OG004|Outcome|Sham rTMS|0.2Hz for 15 minutes:
11147715|NCT01859247|OG001|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes
11147716|NCT01859247|OG002|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes
11147717|NCT01859247|OG003|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes
11147718|NCT01859247|OG004|Outcome|Sham rTMS|0.2Hz for 15 minutes
11147719|NCT01859247|EG000|Reported Event|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
11147720|NCT01859247|EG001|Reported Event|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
11147721|NCT01859247|EG002|Reported Event|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
11147722|NCT01859247|EG003|Reported Event|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
11147723|NCT01859247|EG004|Reported Event|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
11147724|NCT01859247|EG005|Reported Event|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
11147725|NCT01859247|EG006|Reported Event|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
11147726|NCT01859247|EG007|Reported Event|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
11147727|NCT01859312|BG000|Baseline|Continuous Sub-Q Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
11147728|NCT01859312|FG000|Participant Flow|Continuous Sub-Q Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) received continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to achieve near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
11147729|NCT01859312|OG000|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
11147730|NCT01859312|OG000|Outcome|Continuous Subcutaenous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
11150126|NCT01875861|EG001|Reported Event|Comparison|"Usual care with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components."
10887175|NCT00499174|BG001|Baseline|Radical Intervention|"Radical prostatectomy or radiotherapy based on patient and physician preference~conventional surgery: Radical prostatectomy~brachytherapy: high dose rate temporary seed implant; permanent seed implant.~external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy.~Biopsies: Periodic repeat biopsies"
10887176|NCT00499174|BG002|Baseline|Total|Total of all reporting groups
10884350|NCT00482053|FG000|Participant Flow|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
10884351|NCT00482053|OG000|Outcome|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
10884352|NCT00482053|EG000|Reported Event|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
10884353|NCT00482170|BG000|Baseline|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
10884354|NCT00482170|BG001|Baseline|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
10884355|NCT00482170|BG002|Baseline|Total|Total of all reporting groups
10884356|NCT00482170|FG000|Participant Flow|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.
10884357|NCT00482170|FG001|Participant Flow|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.
10884358|NCT00482170|OG000|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
10884359|NCT00482170|OG001|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
10884360|NCT00482170|EG000|Reported Event|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
10884361|NCT00482170|EG001|Reported Event|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
10884362|NCT00482274|BG000|Baseline|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
10884363|NCT00482274|FG000|Participant Flow|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
10884364|NCT00482274|OG000|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
10884365|NCT00482274|EG000|Reported Event|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
10884366|NCT00482391|BG000|Baseline|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
10884367|NCT00482391|FG000|Participant Flow|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
10887177|NCT00499174|FG000|Participant Flow|Active Surveillance|Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
11147731|NCT01859312|EG000|Reported Event|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
11225447|NCT02367872|EG004|Reported Event|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
10884368|NCT00482391|OG000|Outcome|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
10884369|NCT00482391|OG000|Outcome|Dose-dense Adjuvant/ Neoadjuvant Chemotherapy Regimen|
10884370|NCT00482391|EG000|Reported Event|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
10884371|NCT00482547|BG000|Baseline|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
10884372|NCT00482547|BG001|Baseline|Silicone-coated Catheter|silicone elastomer-coated latex catheter
10884373|NCT00482547|BG002|Baseline|Total|Total of all reporting groups
10884374|NCT00482547|FG000|Participant Flow|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
10884375|NCT00482547|FG001|Participant Flow|Silicone-coated Catheter|silicone elastomer-coated latex catheter
10884376|NCT00482547|OG000|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
10884377|NCT00482547|OG001|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
10884378|NCT00482547|EG000|Reported Event|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
10884379|NCT00482547|EG001|Reported Event|Silicone-coated Catheter|silicone elastomer-coated latex catheter
10884380|NCT00482612|BG000|Baseline|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
10884381|NCT00482612|BG001|Baseline|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
10884382|NCT00482612|BG002|Baseline|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
10884383|NCT00482612|BG003|Baseline|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
10884384|NCT00482612|BG004|Baseline|Total|Total of all reporting groups
10884385|NCT00482612|FG000|Participant Flow|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
10884386|NCT00482612|FG001|Participant Flow|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
10884387|NCT00482612|FG002|Participant Flow|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
11009902|NCT01104558|BG000|Baseline|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
10884388|NCT00482612|FG003|Participant Flow|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
10884389|NCT00482612|OG000|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
10884390|NCT00482612|OG001|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
10884391|NCT00482612|OG002|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
10884392|NCT00482612|OG003|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
10884393|NCT00482612|EG000|Reported Event|Esmirtazapine 1.5 mg In-treatment|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
10884394|NCT00482612|EG001|Reported Event|Esmirtazapine 3.0 mg In-Treatment|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
10884395|NCT00482612|EG002|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
10884396|NCT00482612|EG003|Reported Event|Placebo In-treatment|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
10884397|NCT00482612|EG004|Reported Event|Esmirtazapine 1.5 mg Follow-up|After receiving 1.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
10884398|NCT00482612|EG005|Reported Event|Esmirtazapine 3.0 mg Folow-up|After receiving 3.0 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
10884399|NCT00482612|EG006|Reported Event|Esmirtazapine 4.5 mg Follow-up|After receiving 4.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
10884400|NCT00482612|EG007|Reported Event|Placebo Follow-up|After receiving placebo in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
10884401|NCT00482625|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10884402|NCT00482625|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10884403|NCT00482625|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10884404|NCT00482625|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10884405|NCT00482677|BG000|Baseline|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
10884406|NCT00482677|BG001|Baseline|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
10884407|NCT00482677|BG002|Baseline|Total|Total of all reporting groups
10884408|NCT00482677|FG000|Participant Flow|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
10884409|NCT00482677|FG001|Participant Flow|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
10884410|NCT00482677|OG000|Outcome|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
10884411|NCT00482677|OG001|Outcome|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
10884412|NCT00482677|EG000|Reported Event|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
11342103|NCT03697083|FG001|Participant Flow|Active Control Arm|"Participants will be asked to think about where they will store their prescription.~Active Control: Participants receive 8 text messages asking them to think of where they plan to store their medication once they pick it up and to think about that location on their intended date of pickup."
10849166|NCT00294645|EG001|Reported Event|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
11342104|NCT03697083|FG002|Participant Flow|Baseline Control Arm|"Participants are thanked for enrolling in the reminder program.~Baseline Control: Participants receive 1 text message thanking participants for enrolling in the reminder program. Participants are not contacted further."
10849167|NCT00294658|BG000|Baseline|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
10884413|NCT00482677|EG001|Reported Event|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
10887178|NCT00499174|FG001|Participant Flow|Radical Intervention|"Radical prostatectomy or radiotherapy based on patient and physician preference~conventional surgery: Radical prostatectomy~brachytherapy: high dose rate temporary seed implant; permanent seed implant.~external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy.~Biopsies: Periodic repeat biopsies"
10887179|NCT00499174|OG000|Outcome|Radical Intervention|"Radical prostatectomy or radiotherapy based on patient and physician preference~conventional surgery: Radical prostatectomy~brachytherapy: high dose rate temporary seed implant; permanent seed implant.~external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy.~Biopsies: Periodic repeat biopsies"
10887180|NCT00499174|OG001|Outcome|Active Surveillance|Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
10887181|NCT00499174|OG000|Outcome|Active Surveillance|Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
10887182|NCT00499174|OG001|Outcome|Radical Intervention|"Radical prostatectomy or radiotherapy based on patient and physician preference~conventional surgery: Radical prostatectomy~brachytherapy: high dose rate temporary seed implant; permanent seed implant.~external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy.~Biopsies: Periodic repeat biopsies"
10887183|NCT00499174|EG000|Reported Event|Active Surveillance|Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
10887184|NCT00499174|EG001|Reported Event|Radical Intervention|"Radical prostatectomy or radiotherapy based on patient and physician preference~conventional surgery: Radical prostatectomy~brachytherapy: high dose rate temporary seed implant; permanent seed implant.~external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy.~Biopsies: Periodic repeat biopsies"
10887185|NCT00499252|BG000|Baseline|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
10887186|NCT00499252|FG000|Participant Flow|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
10887187|NCT00499252|OG000|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
10887188|NCT00499252|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10887189|NCT00499252|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10887190|NCT00499252|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10887191|NCT00499252|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10887192|NCT00499252|EG000|Reported Event|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
10887193|NCT00499343|BG000|Baseline|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
10887194|NCT00499343|BG001|Baseline|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
10887195|NCT00499343|BG002|Baseline|Total|Total of all reporting groups
10887196|NCT00499343|FG000|Participant Flow|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
10887197|NCT00499343|FG001|Participant Flow|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
10887198|NCT00499343|OG000|Outcome|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
10887199|NCT00499343|OG001|Outcome|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
10887200|NCT00499343|EG000|Reported Event|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
10887201|NCT00499343|EG001|Reported Event|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
10887202|NCT00499369|BG000|Baseline|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887203|NCT00499369|BG001|Baseline|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887204|NCT00499369|BG002|Baseline|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887205|NCT00499369|BG003|Baseline|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887206|NCT00499369|BG004|Baseline|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887207|NCT00499369|BG005|Baseline|Total|Total of all reporting groups
10884414|NCT00482703|BG000|Baseline|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
10884415|NCT00482703|BG001|Baseline|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
10884416|NCT00482703|BG002|Baseline|Total|Total of all reporting groups
10884417|NCT00482703|FG000|Participant Flow|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
10884418|NCT00482703|FG001|Participant Flow|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
10884419|NCT00482703|OG000|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
10884420|NCT00482703|OG001|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
10884421|NCT00482703|OG002|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
10884422|NCT00482703|OG003|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
10884423|NCT00482703|OG004|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
10884424|NCT00482703|OG005|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
10884425|NCT00482703|OG000|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
10884426|NCT00482703|OG001|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
10884427|NCT00482703|EG000|Reported Event|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
10884428|NCT00482703|EG001|Reported Event|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
10884429|NCT00482703|EG002|Reported Event|Total|
10884430|NCT00482729|BG000|Baseline|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
10884431|NCT00482729|BG001|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
10884432|NCT00482729|BG002|Baseline|Total|Total of all reporting groups
10884433|NCT00482729|FG000|Participant Flow|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
10884434|NCT00482729|FG001|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
10884435|NCT00482729|OG000|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
10884436|NCT00482729|OG001|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
10884437|NCT00482729|EG000|Reported Event|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
10887208|NCT00499369|FG000|Participant Flow|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10884438|NCT00482729|EG001|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
10884439|NCT00482911|BG000|Baseline|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
10884440|NCT00482911|BG001|Baseline|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
10884441|NCT00482911|BG002|Baseline|Total|Total of all reporting groups
10884442|NCT00482911|FG000|Participant Flow|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
10884443|NCT00482911|FG001|Participant Flow|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
10884444|NCT00482911|OG000|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
10884445|NCT00482911|OG001|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
10884446|NCT00482911|EG000|Reported Event|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
10884447|NCT00482911|EG001|Reported Event|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
10884448|NCT00483002|BG000|Baseline|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator's discretion for 12 weeks.
10884449|NCT00483002|FG000|Participant Flow|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator's discretion for 12 weeks.
10884450|NCT00483002|OG000|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator's discretion for 12 weeks.
10884451|NCT00483002|EG000|Reported Event|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator's discretion for 12 weeks.
10884452|NCT00483041|BG000|Baseline|PLACEBO|Placebo administered as a single intravenous dose
10884453|NCT00483041|BG001|Baseline|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
10884454|NCT00483041|BG002|Baseline|Total|Total of all reporting groups
10884455|NCT00483041|FG000|Participant Flow|PLACEBO|Placebo administered as a single intravenous dose
10884456|NCT00483041|FG001|Participant Flow|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
10884457|NCT00483041|OG000|Outcome|PLACEBO|Placebo administered as a single intravenous dose
10884458|NCT00483041|OG001|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
10884459|NCT00483041|EG000|Reported Event|PLACEBO|Placebo administered as a single intravenous dose
10884460|NCT00483041|EG001|Reported Event|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
10884461|NCT00483184|BG000|Baseline|1|(placebo)0 IU IFN alpha
10884462|NCT00483184|BG001|Baseline|2|(Veldona)500 IU IFNα bid
10884463|NCT00483184|BG002|Baseline|3|(Veldona)1000 IU IFNα bid
10884464|NCT00483184|BG003|Baseline|Total|Total of all reporting groups
10884465|NCT00483184|FG000|Participant Flow|1|(placebo)0 IU IFN alpha
10884466|NCT00483184|FG001|Participant Flow|2|(Veldona)500 IU IFNα bid
10884467|NCT00483184|FG002|Participant Flow|3|(Veldona)1000 IU IFNα bid
10884468|NCT00483184|OG000|Outcome|1|(placebo)0 IU IFN alpha
10884469|NCT00483184|OG001|Outcome|2|(Veldona)500 IU IFNα bid
10884470|NCT00483184|OG002|Outcome|3|(Veldona)1000 IU IFNα bid
10884471|NCT00483184|EG000|Reported Event|1|(placebo)0 IU IFN alpha
10884472|NCT00483184|EG001|Reported Event|2|(Veldona)500 IU IFNα bid
10884473|NCT00483184|EG002|Reported Event|3|(Veldona)1000 IU IFNα bid
10884474|NCT00483223|BG000|Baseline|Single Arm|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
10884475|NCT00483223|FG000|Participant Flow|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
10884476|NCT00483223|OG000|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
10884477|NCT00483223|EG000|Reported Event|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
10884478|NCT00483262|BG000|Baseline|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib Phase I part of this Phase I/II study.
10884479|NCT00483262|BG001|Baseline|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib Phase II part of this Phase I/II study
10884480|NCT00483262|BG002|Baseline|Total|Total of all reporting groups
10884481|NCT00483262|FG000|Participant Flow|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib, Phase I part of this Phase I/II study
10884482|NCT00483262|FG001|Participant Flow|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib, Phase II part of this Phase I/II study
10884483|NCT00483262|OG000|Outcome|CCI779 Toxicity Phase I|Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
10884484|NCT00483262|OG001|Outcome|CCI779 Toxicity Phase II|Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
10884485|NCT00483262|OG000|Outcome|CCI779 Response Phase I|Response of PR or better per the Blade criteria in phase I part of this phase I/II study of CCI779 and velcade
11009903|NCT01104558|FG000|Participant Flow|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
10884486|NCT00483262|OG001|Outcome|CCI779 Response Phase II|Response of PR or better per the Blade criteria in phase II part of this phase I/II study of CCI779 and velcade
10884487|NCT00483262|OG000|Outcome|CCI779 PFS Phase I|Progression-free survival results from the phase I part of the phase I/II CCI779 with velcade study.
10884488|NCT00483262|OG001|Outcome|CCI779 PFS Phase II|Progression-free survival results from the phase II part of the phase I/II CCI779 with velcade study.
10884489|NCT00483262|EG000|Reported Event|Adverse Events CCI779 and Bortezomib Phase I|Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.
10884490|NCT00483262|EG001|Reported Event|Adverse Events CCI779 and Bortezomib Phase II|Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.
10884491|NCT00483327|BG000|Baseline|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
10884492|NCT00483327|FG000|Participant Flow|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
10884493|NCT00483327|OG000|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
10884494|NCT00483327|OG000|Outcome|Grade 1 or 2|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
10884495|NCT00483327|OG001|Outcome|Grade 3|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
10884496|NCT00483327|EG000|Reported Event|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
10884497|NCT00483379|BG000|Baseline|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
10884498|NCT00483379|BG001|Baseline|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
10884499|NCT00483379|BG002|Baseline|Total|Total of all reporting groups
10884500|NCT00483379|FG000|Participant Flow|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
10884501|NCT00483379|FG001|Participant Flow|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
10884502|NCT00483379|OG000|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
10884503|NCT00483379|OG001|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
10884504|NCT00483379|EG000|Reported Event|Treatment: Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
10884505|NCT00483379|EG001|Reported Event|Treatment: Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
10884506|NCT00483379|EG002|Reported Event|Extension: Alglucosidase Alfa 20 mg/kg Every Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
10884507|NCT00483379|EG003|Reported Event|Extension: Alglucosidase Alfa 40 mg/kg Every Other Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
10884508|NCT00483405|BG000|Baseline|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
10884509|NCT00483405|FG000|Participant Flow|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
10884510|NCT00483405|OG000|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
10884511|NCT00483405|EG000|Reported Event|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
10884512|NCT00483496|BG000|Baseline|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
10884513|NCT00483496|FG000|Participant Flow|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
10884514|NCT00483496|OG000|Outcome|V0096|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
10884515|NCT00483496|OG001|Outcome|Ti02Pig + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
10884516|NCT00483496|OG002|Outcome|TiO2 Micro + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
11147732|NCT01859325|BG000|Baseline|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
11147733|NCT01859325|BG001|Baseline|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
11147734|NCT01859325|BG002|Baseline|Total|Total of all reporting groups
10884517|NCT00483496|OG003|Outcome|TiO2Pig + TiO2Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
10884518|NCT00483496|OG004|Outcome|Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
10884519|NCT00483496|OG005|Outcome|TiO2 Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
10884520|NCT00483496|OG006|Outcome|TiO2Pig|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
10884521|NCT00483496|OG007|Outcome|Vehicle|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
10884522|NCT00483496|OG000|Outcome|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
10884523|NCT00483496|EG000|Reported Event|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
10884524|NCT00483509|BG000|Baseline|A: NGR-hTNF + Doxorubicin|"NGR-hTNF plus doxorubicin~NGR-hTNF: iv q3W 0.8 mcg/sqm~Doxorubicin: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion"
10884525|NCT00483509|FG000|Participant Flow|A: NGR-hTNF + Doxorubicin|"NGR-hTNF plus doxorubicin~NGR-hTNF: iv q3W 0.8 mcg/sqm NGR-hTNF~Doxorubicin: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion"
10884526|NCT00483509|OG000|Outcome|A: NGR-hTNF + Doxorubicin|"NGR-hTNF plus doxorubicin~NGR-hTNF: iv q3W 0.8 mcg/sqm NGR-hTNF~Doxorubicin: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion"
10884527|NCT00483509|EG000|Reported Event|A: NGR-hTNF + Doxorubicin|"NGR-hTNF plus doxorubicin~NGR-hTNF: iv q3W 0.8 mcg/sqm NGR-hTNF~Doxorubicin: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion"
10884528|NCT00483548|BG000|Baseline|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
11342105|NCT03697083|OG000|Outcome|Reminders Through Association Arm|"participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription.~Reminders Through Association: Participants receive 8 text messages asking them to think of a reminder cue that will help them remember to pick up the prescription and use the cue."
10849168|NCT00294658|BG001|Baseline|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
10849169|NCT00294658|BG002|Baseline|Total|Total of all reporting groups
10849170|NCT00294658|FG000|Participant Flow|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy had been performed as soon as possible after randomization."
10849171|NCT00294658|FG001|Participant Flow|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen had been taken every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
10849172|NCT00294658|OG000|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
10849173|NCT00294658|OG001|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
10849174|NCT00294658|EG000|Reported Event|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
10849175|NCT00294658|EG001|Reported Event|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
10849176|NCT00294671|BG000|Baseline|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
10849177|NCT00294671|BG001|Baseline|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
10849178|NCT00294671|BG002|Baseline|Total|Total of all reporting groups
10849179|NCT00294671|FG000|Participant Flow|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
10849180|NCT00294671|FG001|Participant Flow|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
10849181|NCT00294671|OG000|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
10849182|NCT00294671|OG001|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
10849183|NCT00294671|EG000|Reported Event|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
10849184|NCT00294671|EG001|Reported Event|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
10849185|NCT00294684|BG000|Baseline|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
10849186|NCT00294684|BG001|Baseline|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
10849187|NCT00294684|BG002|Baseline|Total|Total of all reporting groups
10849188|NCT00294684|FG000|Participant Flow|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
10849189|NCT00294684|FG001|Participant Flow|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
10849190|NCT00294684|OG000|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
10849405|NCT00296140|OG000|Outcome|Self Management of PSD Symptoms|Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.
10884529|NCT00483548|BG001|Baseline|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
10884530|NCT00483548|BG002|Baseline|Total|Total of all reporting groups
10884531|NCT00483548|FG000|Participant Flow|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
10884532|NCT00483548|FG001|Participant Flow|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
10884533|NCT00483548|OG000|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
10884534|NCT00483548|OG001|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
10884535|NCT00483548|EG000|Reported Event|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
10884536|NCT00483548|EG001|Reported Event|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
10884537|NCT00483561|BG000|Baseline|Gefitinib Plus Etoposide|"Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1 and taken on a continuous basis throughout the trial with Etoposide-50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).~Patients with stable disease will be treated for 2 additional cycles beyond maximum response, for a maximum of 6 cycles. Restaging will be performed every 2 cycles. After completion of treatment, patients will continue to be followed for survival."
10884538|NCT00483561|FG000|Participant Flow|Gefitinib Plus Etoposide|"Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1 and taken on a continuous basis throughout the trial with Etoposide-50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).~Patients with stable disease will be treated for 2 additional cycles beyond maximum response, for a maximum of 6 cycles. Restaging will be performed every 2 cycles. After completion of treatment, patients will continue to be followed for survival."
10884539|NCT00483561|OG000|Outcome|Gefitinib Plus Etoposide|"Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1 and taken on a continuous basis throughout the trial with Etoposide-50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).~Patients with stable disease will be treated for 2 additional cycles beyond maximum response, for a maximum of 6 cycles. Restaging will be performed every 2 cycles. After completion of treatment, patients will continue to be followed for survival."
10884540|NCT00483561|EG000|Reported Event|Gefitinib Plus Etoposide|"Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial.~Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).~Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple)."
10884541|NCT00483574|BG000|Baseline|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
11225448|NCT02367872|EG005|Reported Event|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
10884542|NCT00483574|BG001|Baseline|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
10884543|NCT00483574|BG002|Baseline|Total|Total of all reporting groups
10887209|NCT00499369|FG001|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10884544|NCT00483574|FG000|Participant Flow|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
10884545|NCT00483574|FG001|Participant Flow|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
10884546|NCT00483574|OG000|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
10884547|NCT00483574|OG001|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
10884548|NCT00483574|OG000|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMR+V: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. (0.5 mL, intramuscular, respectively)
10884549|NCT00483574|OG001|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
10884550|NCT00483574|EG000|Reported Event|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
10884551|NCT00483574|EG001|Reported Event|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
10884552|NCT00483652|BG000|Baseline|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
10884553|NCT00483652|BG001|Baseline|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
10884554|NCT00483652|BG002|Baseline|Total|Total of all reporting groups
10884555|NCT00483652|FG000|Participant Flow|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
10884556|NCT00483652|FG001|Participant Flow|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
10884557|NCT00483652|OG000|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
10884558|NCT00483652|OG001|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
10884559|NCT00483652|EG000|Reported Event|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
10884560|NCT00483652|EG001|Reported Event|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
10884561|NCT00483704|BG000|Baseline|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
10884562|NCT00483704|BG001|Baseline|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
10884563|NCT00483704|BG002|Baseline|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
10884564|NCT00483704|BG003|Baseline|Total|Total of all reporting groups
10884565|NCT00483704|FG000|Participant Flow|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
10884566|NCT00483704|FG001|Participant Flow|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
10884567|NCT00483704|FG002|Participant Flow|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
10884568|NCT00483704|OG000|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
10884569|NCT00483704|OG001|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
11225449|NCT02367872|EG006|Reported Event|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
10884570|NCT00483704|OG002|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
10884571|NCT00483704|OG000|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
10884572|NCT00483704|OG001|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
10884573|NCT00483704|OG002|Outcome|Placebo|Participants who received at least one dose of placebo.
10884574|NCT00483704|EG000|Reported Event|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
10884575|NCT00483704|EG001|Reported Event|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
10884576|NCT00483704|EG002|Reported Event|Placebo|Participants who received at least one dose of placebo.
10884577|NCT00483717|BG000|Baseline|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
10884578|NCT00483717|BG001|Baseline|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
10884579|NCT00483717|BG002|Baseline|Total|Total of all reporting groups
10884580|NCT00483717|FG000|Participant Flow|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
10884581|NCT00483717|FG001|Participant Flow|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
10884582|NCT00483717|OG000|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
10884583|NCT00483717|OG001|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
10884584|NCT00483717|EG000|Reported Event|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
10884585|NCT00483717|EG001|Reported Event|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
10884586|NCT00483756|BG000|Baseline|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
10884587|NCT00483756|BG001|Baseline|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
10884588|NCT00483756|BG002|Baseline|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
10884589|NCT00483756|BG003|Baseline|Total|Total of all reporting groups
10884590|NCT00483756|FG000|Participant Flow|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
10884591|NCT00483756|FG001|Participant Flow|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
10884592|NCT00483756|FG002|Participant Flow|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
10884593|NCT00483756|OG000|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
10884594|NCT00483756|OG001|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
10884595|NCT00483756|OG002|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
10884596|NCT00483756|EG000|Reported Event|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
10884597|NCT00483756|EG001|Reported Event|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
10884598|NCT00483756|EG002|Reported Event|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
10887210|NCT00499369|FG002|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
11147735|NCT01859325|FG000|Participant Flow|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
11147736|NCT01859325|FG001|Participant Flow|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
11147737|NCT01859325|FG002|Participant Flow|Excluded|Participants not meeting inclusion criteria or declined to participate.
11147738|NCT01859325|OG000|Outcome|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
11147739|NCT01859325|OG001|Outcome|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
11147740|NCT01859325|EG000|Reported Event|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
11147741|NCT01859325|EG001|Reported Event|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
11147742|NCT01859390|BG000|Baseline|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
11147743|NCT01859390|BG001|Baseline|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
11147744|NCT01859390|BG002|Baseline|Total|Total of all reporting groups
10887211|NCT00499369|FG003|Participant Flow|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
11147745|NCT01859390|FG000|Participant Flow|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
10887212|NCT00499369|FG004|Participant Flow|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10884599|NCT00483938|BG000|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
10884600|NCT00483938|BG001|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
10884601|NCT00483938|BG002|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
10884602|NCT00483938|BG003|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884603|NCT00483938|BG004|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
10884604|NCT00483938|BG005|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
11147746|NCT01859390|FG001|Participant Flow|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
11147747|NCT01859390|OG000|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
11147748|NCT01859390|OG001|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
11147749|NCT01859390|EG000|Reported Event|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
11147750|NCT01859390|EG001|Reported Event|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
10884605|NCT00483938|BG006|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884606|NCT00483938|BG007|Baseline|Total|Total of all reporting groups
10884607|NCT00483938|FG000|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
10884608|NCT00483938|FG001|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
10884609|NCT00483938|FG002|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
10849228|NCT00295009|FG002|Participant Flow|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
10849229|NCT00295009|FG003|Participant Flow|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
10849230|NCT00295009|FG004|Participant Flow|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
10849231|NCT00295009|FG005|Participant Flow|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
10849232|NCT00295009|OG000|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
10849233|NCT00295009|OG001|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
10849234|NCT00295009|OG002|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
10849235|NCT00295009|OG003|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
10849236|NCT00295009|OG004|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
10849237|NCT00295009|OG005|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
10849238|NCT00295009|EG000|Reported Event|1-Level Fusion|Circumferential fusion at a single lumbar level.
10849239|NCT00295009|EG001|Reported Event|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
10849240|NCT00295009|EG002|Reported Event|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
10849241|NCT00295009|EG003|Reported Event|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
10849242|NCT00295009|EG004|Reported Event|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
10849243|NCT00295009|EG005|Reported Event|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
10849244|NCT00295022|BG000|Baseline|Placebo (PBO)|Placebo was administered orally on Days 1 and 2.
10849245|NCT00295022|BG001|Baseline|Levocetirizine (LCTZ)|5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10849246|NCT00295022|BG002|Baseline|Montelukast (MLKT)|10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
10849247|NCT00295022|BG003|Baseline|Total Title|
10849248|NCT00295022|FG000|Participant Flow|Placebo (PBO)|Placebo was administered orally on Days 1 and 2.
10849249|NCT00295022|FG001|Participant Flow|Levocetirizine (LCTZ)|5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10849250|NCT00295022|FG002|Participant Flow|Montelukast (MLKT)|10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
10849251|NCT00295022|OG000|Outcome|Placebo (PBO)|Placebo was administered orally on Days 1 and 2.
10849252|NCT00295022|OG001|Outcome|Levocetirizine (LCTZ)|5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10849253|NCT00295022|OG002|Outcome|Montelukast (MLKT)|10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
10849254|NCT00295022|OG001|Outcome|Montelukast (MLKT)|10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
10849255|NCT00295022|OG002|Outcome|Levocetirizine (LCTZ)|5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10849256|NCT00295022|EG000|Reported Event|Placebo (PBO)|Placebo was administered orally on Days 1 and 2.
10849257|NCT00295022|EG001|Reported Event|Levocetirizine (LCTZ)|5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10849258|NCT00295022|EG002|Reported Event|Montelukast (MLKT)|10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
10849259|NCT00295061|BG000|Baseline|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
10849260|NCT00295061|BG001|Baseline|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
10849261|NCT00295061|BG002|Baseline|Total|Total of all reporting groups
10849262|NCT00295061|FG000|Participant Flow|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 modified process (MP) (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
10849263|NCT00295061|FG001|Participant Flow|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
10849264|NCT00295061|OG000|Outcome|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
10849265|NCT00295061|OG001|Outcome|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
10849266|NCT00295061|EG000|Reported Event|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
10849267|NCT00295061|EG001|Reported Event|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
10849268|NCT00295503|BG000|Baseline|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks
10849269|NCT00295503|FG000|Participant Flow|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
10849270|NCT00295503|OG000|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
10849271|NCT00295503|OG000|Outcome|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
10849272|NCT00295503|EG000|Reported Event|Experimental Arm|cisplatin, pemetrexed, and bevacizumab
10849273|NCT00295620|BG000|Baseline|Arm A: Anastrozol|1 mg per day for 2 years
10884610|NCT00483938|FG003|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884611|NCT00483938|FG004|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
10884612|NCT00483938|FG005|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
11147751|NCT01859403|BG000|Baseline|Usual Care|"Usual care for veterans as part of the MOVE! program~Usual Care: Patients receive the same dietary recommendation regardless of their genetic information"
11147752|NCT01859403|BG001|Baseline|Personalized Genomics|"Personalized genomics information from the FIT Test, Pathway Genomics~Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise"
11147753|NCT01859403|BG002|Baseline|Total|Total of all reporting groups
11147754|NCT01859403|FG000|Participant Flow|Usual Care|"Usual care for veterans as part of the MOVE! program~Usual Care: Patients receive the same dietary recommendation regardless of their genetic information"
11147755|NCT01859403|FG001|Participant Flow|Personalized Genomics|"Personalized genomics information from the FIT Test, Pathway Genomics~Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise"
11147756|NCT01859403|OG000|Outcome|Usual Care|"Usual care for veterans as part of the MOVE! program~Usual Care: Patients receive the same dietary recommendation regardless of their genetic information"
11147757|NCT01859403|OG001|Outcome|Personalized Genomics|"Personalized genomics information from the FIT Test, Pathway Genomics~Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise"
10884613|NCT00483938|FG006|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
11147758|NCT01859403|EG000|Reported Event|Usual Care|"Usual care for veterans as part of the MOVE! program~Usual Care: Patients receive the same dietary recommendation regardless of their genetic information"
11147759|NCT01859403|EG001|Reported Event|Personalized Genomics|"Personalized genomics information from the FIT Test, Pathway Genomics~Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise"
11147760|NCT01859494|BG000|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
11147761|NCT01859494|FG000|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
11147762|NCT01859494|OG000|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
11147763|NCT01859494|EG000|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
11147764|NCT01859507|BG000|Baseline|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
11147765|NCT01859507|FG000|Participant Flow|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
11147766|NCT01859507|OG000|Outcome|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
11150127|NCT01875874|BG000|Baseline|ELAD Treatment Plus Standard of Care Treatment|"Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.~ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total)."
11009904|NCT01104558|OG000|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
11147767|NCT01859507|OG000|Outcome|BOTOX Group|"Injection of BOTOX 100 units vial as a single dose intramuscular in the perineal muscles. Proper informed consent forms will be signed. In most of the cases we use local anesthetic before injection. However in V4 and 5 we resort to general anesthesia. We followed up the patient by phone calls daily for possible adverse effects following the procedure for 4 days, which is the interval allowed for the BOTOX to be fully effective. The patient is then instructed to attend dilatation sessions twice weekly in the clinic, in the presence of the husband, for 3-4 weeks. We use silicone dilators covered by lubricated condoms. We start each session with the appropriate size of the dilator according to the capacity of the introitus and increase the size gradually thereafter. We proceed till the patient uses the largest dilator with no or limited pain. The patient is then advised then to try to have intercourse and report back to us.~Botox: In the first session, proper histor"
11147768|NCT01859507|EG000|Reported Event|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
11147769|NCT01859598|BG000|Baseline|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
11147770|NCT01859598|FG000|Participant Flow|6-month Follow-up for Basal Insulin Treatment Study (ORBIT)|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
11147771|NCT01859598|OG000|Outcome|Basal Insulin Treatment Study (ORBIT)|
11147772|NCT01859598|OG000|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
11147773|NCT01859598|OG000|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
11147774|NCT01859598|EG000|Reported Event|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
10849274|NCT00295620|BG001|Baseline|Arm B: Anastrozol|1 mg per day for 5 years
10849275|NCT00295620|BG002|Baseline|Total|Total of all reporting groups
10849276|NCT00295620|FG000|Participant Flow|Arm A: Anastrozol|1 mg per day for 2 years
10849277|NCT00295620|FG001|Participant Flow|Arm B: Anastrozol|1 mg per day for 5 years
10849278|NCT00295620|OG000|Outcome|Arm A: Anastrozol|1 mg per day for 2 years
10849279|NCT00295620|OG001|Outcome|Arm B: Anastrozol|1 mg per day for 5 years
10849280|NCT00295620|EG000|Reported Event|Arm B: Anastrozol - 1 mg Per Day for 5 Years|Description (Arm-group)
10849281|NCT00295620|EG001|Reported Event|Arm A: Anastrozol - 1 mg Per Day for 2 Years|Description (Arm-group)
10849282|NCT00295633|BG000|Baseline|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849283|NCT00295633|BG001|Baseline|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849284|NCT00295633|BG002|Baseline|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849285|NCT00295633|BG003|Baseline|Total|Total of all reporting groups
10849286|NCT00295633|FG000|Participant Flow|Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849287|NCT00295633|FG001|Participant Flow|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849288|NCT00295633|FG002|Participant Flow|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849289|NCT00295633|OG000|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849290|NCT00295633|OG001|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849291|NCT00295633|OG002|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
10849292|NCT00295633|EG000|Reported Event|PLA + TZD|
10849293|NCT00295633|EG001|Reported Event|SAXA 2.5MG + TZD|
10849294|NCT00295633|EG002|Reported Event|SAXA 5MG + TZD|
10849295|NCT00295750|BG000|Baseline|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
10884614|NCT00483938|OG000|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
10884615|NCT00483938|OG001|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
10884616|NCT00483938|OG000|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
10884617|NCT00483938|OG001|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884618|NCT00483938|OG002|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
10884619|NCT00483938|OG003|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884620|NCT00483938|OG002|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
10884621|NCT00483938|OG003|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884622|NCT00483938|OG004|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
10884623|NCT00483938|OG005|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884624|NCT00483938|EG000|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
10884625|NCT00483938|EG001|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
10884626|NCT00483938|EG002|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
10884627|NCT00483938|EG003|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884628|NCT00483938|EG004|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
10884629|NCT00483938|EG005|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884630|NCT00483938|EG006|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
10884631|NCT00484094|BG000|Baseline|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10884632|NCT00484094|FG000|Participant Flow|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10884633|NCT00484094|OG000|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10884634|NCT00484094|EG000|Reported Event|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10884635|NCT00484159|BG000|Baseline|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
10884636|NCT00484159|BG001|Baseline|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
10884637|NCT00484159|BG002|Baseline|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
10884638|NCT00484159|BG003|Baseline|Total|Total of all reporting groups
10884639|NCT00484159|FG000|Participant Flow|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
10884640|NCT00484159|FG001|Participant Flow|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
10884641|NCT00484159|FG002|Participant Flow|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
10884642|NCT00484159|OG000|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
10884643|NCT00484159|OG001|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
10884644|NCT00484159|OG002|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
10884645|NCT00484159|EG000|Reported Event|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
10884646|NCT00484159|EG001|Reported Event|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
10884647|NCT00484159|EG002|Reported Event|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
10884648|NCT00484185|BG000|Baseline|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician's discretion, were observed for a period of 6 months.
10884649|NCT00484185|FG000|Participant Flow|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician's discretion, were observed for a period of 6 months.
10884650|NCT00484185|OG000|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician's discretion, were observed for a period of 6 months.
10884651|NCT00484185|EG000|Reported Event|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician's discretion, were observed for a period of 6 months.
10884652|NCT00484198|BG000|Baseline|Placebo|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
10884653|NCT00484198|BG001|Baseline|Rivoglitazone 1.0 mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.
10884654|NCT00484198|BG002|Baseline|Rivoglitazone 1.5 mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.
10884655|NCT00484198|BG003|Baseline|Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
10884656|NCT00484198|BG004|Baseline|Total|Total of all reporting groups
10884657|NCT00484198|FG000|Participant Flow|Placebo|"Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.~Extension Period:~Participants who received Placebo in the base study received Pioglitazone 45 mg once daily for 26-week cycles (Cycle 1 and 2) instead in the extension period."
10884658|NCT00484198|FG001|Participant Flow|Rivoglitazone 1.0 mg|"Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.~Extension Period:~Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 week cycles (Cycle 1 and 2)."
10884659|NCT00484198|FG002|Participant Flow|Rivoglitazone 1.5 mg|"Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.~Extension Period:~Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks cycles (Cycle 1 and 2)."
10884660|NCT00484198|FG003|Participant Flow|Pioglitazone 45 mg|"Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.~Extension Period:~Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 week cycles (Cycle 1 and Cycle 2)."
10884661|NCT00484198|OG000|Outcome|Placebo|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
10884662|NCT00484198|OG001|Outcome|Rivoglitazone 1.0 mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.
10884663|NCT00484198|OG002|Outcome|Rivoglitazone 1.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.
10884664|NCT00484198|OG003|Outcome|Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
10884665|NCT00484198|OG000|Outcome|Rivoglitazone 1.0 mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.
10884666|NCT00484198|OG001|Outcome|Rivoglitazone 1.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.
10884667|NCT00484198|OG002|Outcome|Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
10884668|NCT00484198|OG003|Outcome|Placebo/Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
10884669|NCT00484198|OG003|Outcome|Placebo/ Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
10884670|NCT00484198|EG000|Reported Event|Placebo|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
10884671|NCT00484198|EG001|Reported Event|Rivoglitazone 1.0 mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.
10884672|NCT00484198|EG002|Reported Event|Rivoglitazone 1.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.
10884673|NCT00484198|EG003|Reported Event|Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
10884674|NCT00484289|BG000|Baseline|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
10884675|NCT00484289|BG001|Baseline|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
10884676|NCT00484289|BG002|Baseline|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
10884677|NCT00484289|BG003|Baseline|Total|Total of all reporting groups
10884678|NCT00484289|FG000|Participant Flow|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
10884679|NCT00484289|FG001|Participant Flow|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
10884680|NCT00484289|FG002|Participant Flow|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
10884681|NCT00484289|OG000|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
10884682|NCT00484289|OG001|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
10884683|NCT00484289|OG002|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
10884684|NCT00484289|OG000|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
10884685|NCT00484289|EG000|Reported Event|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
10884686|NCT00484289|EG001|Reported Event|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
10884687|NCT00484289|EG002|Reported Event|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
10884688|NCT00484315|BG000|Baseline|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
10884689|NCT00484315|BG001|Baseline|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
10884690|NCT00484315|BG002|Baseline|Total|Total of all reporting groups
10884691|NCT00484315|FG000|Participant Flow|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
10884692|NCT00484315|FG001|Participant Flow|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
10884693|NCT00484315|OG000|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
10884694|NCT00484315|OG001|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
10884695|NCT00484315|EG000|Reported Event|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
10884696|NCT00484315|EG001|Reported Event|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
10884697|NCT00484354|BG000|Baseline|IV Sodium Bicarbonate|IV sodium bicarbonate given with amount based on patient weight
10884698|NCT00484354|BG001|Baseline|IV Normal Saline|IV Normal saline with volume given determined by patient weight
10884699|NCT00484354|BG002|Baseline|Total|Total of all reporting groups
10884700|NCT00484354|FG000|Participant Flow|IV Sodium Bicarbonate|IV sodium bicarbonate given with amount based on patient weight
10884701|NCT00484354|FG001|Participant Flow|IV Normal Saline|IV Normal saline with volume given determined by patient weight
10884702|NCT00484354|OG000|Outcome|IV Sodium Bicarbonate|IV sodium bicarbonate given with amount based on patient weight
10884703|NCT00484354|OG001|Outcome|IV Normal Saline|IV Normal saline with volume given determined by patient weight
10884704|NCT00484354|EG000|Reported Event|IV Sodium Bicarbonate|IV sodium bicarbonate given with amount based on patient weight
10884705|NCT00484354|EG001|Reported Event|IV Normal Saline|IV Normal saline with volume given determined by patient weight
10884706|NCT00484393|BG000|Baseline|Tetracaine First|Tetracaine 4% gel 1g applied to injection site first, then placebo with subsequent injection
10884707|NCT00484393|BG001|Baseline|Placebo First|Placebo cream (Aquatain) 1g applied to inejction site first, then tetracaine with subsequent injection
10884708|NCT00484393|BG002|Baseline|Total|Total of all reporting groups
10884709|NCT00484393|FG000|Participant Flow|Tetracaine Then Placebo|Tetracaine 4% gel 1g applied to injection site prior to next palivizumab injection after enrollment Placebo cream (Aquatain) 1g applied to inejction site prior to subsequent palivizumab injection (1 month after 1st study injection)
10884710|NCT00484393|FG001|Participant Flow|Placebo Then Tetracaine|Placebo cream (Aquatain) 1g applied to inejction site prior to next palivizumab injection after enrollment Tetracaine 4% gel 1g applied to injection site prior to subsequent palivizumab injection (1 month after 1st study injection)
10884711|NCT00484393|OG000|Outcome|Tetracaine|Tetracaine 4% gel 1g applied to injection site
10884712|NCT00484393|OG001|Outcome|Placebo|Placebo cream (Aquatain) 1g applied to inejction site
10884713|NCT00484393|EG000|Reported Event|Tetracaine|"Tetracaine 4% gel 1g applied to injection site~tetracaine 4% gel: tetracaine applied prior to 1 injection"
10884714|NCT00484393|EG001|Reported Event|Placebo|"Placebo cream (Aquatain) 1g applied to inejction site~Placebo: placebo applied prior to 1 injection"
10884715|NCT00484679|BG000|Baseline|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
10884716|NCT00484679|FG000|Participant Flow|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
10884717|NCT00484679|OG000|Outcome|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
10884718|NCT00484679|EG000|Reported Event|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
10884719|NCT00484874|BG000|Baseline|A Single Dose of I-131 Tositumomab|I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
10884720|NCT00484874|FG000|Participant Flow|A Single Dose of I-131 Tositumomab|I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
10884721|NCT00484874|OG000|Outcome|A Single Dose of I-131 Tositumomab|"Non-myeloablative maximum tolerated dose of I-131 Tositumomab that can be given to patients with relapsed/refractory Hodgkin's lymphoma.~I-131 Tositumomab therapeutic regimen: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose."
10884722|NCT00484874|OG000|Outcome|A Single Dose of I-131 Tositumomab|"A single therapeutic dosage of 131I-tositumomab.~I-131 Tositumomab therapeutic regimen: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose."
10884723|NCT00484874|OG000|Outcome|A Single Therapeutic Dosage of 131I-tositumomab|"A single therapeutic dosage of 131I-tositumomab in patients who have undergone transplant.~I-131 Tositumomab therapeutic regimen: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose."
10884724|NCT00484874|OG000|Outcome|Treatment|"A single therapeutic dosage of 131I-tositumomab.~I-131 Tositumomab therapeutic regimen: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose."
10884725|NCT00484874|EG000|Reported Event|A Single Dose of I-131 Tositumomab|I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
10884726|NCT00484939|BG000|Baseline|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
10884727|NCT00484939|BG001|Baseline|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
10884728|NCT00484939|BG002|Baseline|Total|Total of all reporting groups
10884729|NCT00484939|FG000|Participant Flow|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
10884730|NCT00484939|FG001|Participant Flow|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
10884731|NCT00484939|OG000|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
10884732|NCT00484939|OG001|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
10884733|NCT00484939|EG000|Reported Event|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
10884734|NCT00484939|EG001|Reported Event|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
10884735|NCT00485069|BG000|Baseline|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884736|NCT00485069|BG001|Baseline|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
10884737|NCT00485069|BG002|Baseline|Total|Total of all reporting groups
10884738|NCT00485069|FG000|Participant Flow|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884739|NCT00485069|FG001|Participant Flow|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
10884740|NCT00485069|OG000|Outcome|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884741|NCT00485069|OG001|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
10884742|NCT00485069|OG000|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884743|NCT00485069|OG000|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884744|NCT00485069|OG001|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884745|NCT00485069|OG000|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
10884746|NCT00485069|OG001|Outcome|"ROP+L-Dopa, Off Sate (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884747|NCT00485069|OG000|Outcome|"ROP+L-Dopa, Off Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884748|NCT00485069|OG001|Outcome|"ROP+L-Dopa, On Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884749|NCT00485069|EG000|Reported Event|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
10884750|NCT00485069|EG001|Reported Event|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
10884751|NCT00485134|BG000|Baseline|Stage 1: Group A, Dolphin 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884752|NCT00485134|BG001|Baseline|Stage 1: Group B, Dolphin 480 µg|"480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884753|NCT00485134|BG002|Baseline|Stage 1: Group C, Dolphin 690 µg|"690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884754|NCT00485134|BG003|Baseline|Stage 1: Group D, Pipette 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. These subjects received 200 μL the vaccine via electronic pipette. This group is for lot bridging only, not included in dose-finding study.~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884755|NCT00485134|BG004|Baseline|Stage 2: Dolphin 690 ug (CTC WRAIR Site)|"690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884756|NCT00485134|BG005|Baseline|Stage 2: Placebo Group (CTC WRAIR Site)|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884757|NCT00485134|BG006|Baseline|Stage 2: Dolphin 690 ug (JHU CIR Site)|"690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884758|NCT00485134|BG007|Baseline|Stage 2: Placebo Group (JHU CIR Site)|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884759|NCT00485134|BG008|Baseline|Total|Total of all reporting groups
10884760|NCT00485134|FG000|Participant Flow|Stage 1: Group A, Dolphin 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of lipopolysaccharides (LPS). 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884761|NCT00485134|FG001|Participant Flow|Stage 1: Group B, Dolphin 480 µg|"480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884762|NCT00485134|FG002|Participant Flow|Stage 1: Group C, Dolphin 690 µg|"690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884763|NCT00485134|FG003|Participant Flow|Stage 1: Group D, Pipette 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. These subjects received 200 μL the vaccine via electronic pipette. This group is for lot bridging only, not included in dose-finding study.~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884764|NCT00485134|FG004|Participant Flow|Stage 2: Dolphin 690 ug (CTC WRAIR Site)|"690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
11225450|NCT02367872|EG007|Reported Event|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
11225451|NCT02367872|EG008|Reported Event|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
10884765|NCT00485134|FG005|Participant Flow|Stage 2: Placebo Group (CTC WRAIR Site)|"Stage 2: Placebo group (CTC WRAIR site) A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884766|NCT00485134|FG006|Participant Flow|Stage 2: Dolphin 690 ug (JHU CIR Site)|"690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884767|NCT00485134|FG007|Participant Flow|Stage 2: Placebo Group (JHU CIR Site)|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884768|NCT00485134|OG000|Outcome|Stage 2: Controls|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
10884769|NCT00485134|OG001|Outcome|Stage 2: Immunized|"The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
10884770|NCT00485134|OG000|Outcome|Stage 1: Group A, Dolphin 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884771|NCT00485134|OG001|Outcome|Stage 1: Group B, Dolphin 480 µg|"480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884772|NCT00485134|OG002|Outcome|Stage 1: Group C, Dolphin 690 µg|"690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884773|NCT00485134|EG000|Reported Event|Stage 1: Group A, Dolphin 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884774|NCT00485134|EG001|Reported Event|Stage 1: Group B, Dolphin 480 µg|"480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
10884775|NCT00485134|EG002|Reported Event|Stage 1: Group C, Dolphin 690 µg|"690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
11009905|NCT01104558|EG000|Reported Event|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
10884776|NCT00485134|EG003|Reported Event|Stage 2: Immunized|"The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884777|NCT00485134|EG004|Reported Event|Stage 2: Controls|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
10884778|NCT00485173|BG000|Baseline|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
10884779|NCT00485173|BG001|Baseline|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
10884780|NCT00485173|BG002|Baseline|Total|Total of all reporting groups
10884781|NCT00485173|FG000|Participant Flow|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
10884782|NCT00485173|FG001|Participant Flow|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
10884783|NCT00485173|OG000|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
10884784|NCT00485173|OG001|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
10884785|NCT00485173|EG000|Reported Event|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
10884786|NCT00485173|EG001|Reported Event|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
10884787|NCT00485264|BG000|Baseline|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
10884788|NCT00485264|BG001|Baseline|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
10884789|NCT00485264|BG002|Baseline|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
10884790|NCT00485264|BG003|Baseline|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
10884791|NCT00485264|BG004|Baseline|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884792|NCT00485264|BG005|Baseline|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data..
10884793|NCT00485264|BG006|Baseline|Total|Total of all reporting groups
10884794|NCT00485264|FG000|Participant Flow|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
11225452|NCT02367885|BG000|Baseline|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
11225453|NCT02367885|BG001|Baseline|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
10884795|NCT00485264|FG001|Participant Flow|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
10884796|NCT00485264|FG002|Participant Flow|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
10884797|NCT00485264|FG003|Participant Flow|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
10884798|NCT00485264|FG004|Participant Flow|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884799|NCT00485264|FG005|Participant Flow|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884800|NCT00485264|OG000|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
10884801|NCT00485264|OG001|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
10884802|NCT00485264|OG002|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
10884803|NCT00485264|OG003|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
10884804|NCT00485264|OG004|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884805|NCT00485264|OG005|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884806|NCT00485264|OG004|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir granules for oral suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884807|NCT00485264|OG005|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. .
10884808|NCT00485264|OG005|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data..
10884809|NCT00485264|OG004|Outcome|Cohort IV -Data Not Included in This Interim Analysis.|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884810|NCT00485264|OG005|Outcome|Cohort V -Data Not Included in This Interim Analysis.|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884811|NCT00485264|EG000|Reported Event|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
10884812|NCT00485264|EG001|Reported Event|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
10884813|NCT00485264|EG002|Reported Event|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
10884814|NCT00485264|EG003|Reported Event|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
10884815|NCT00485264|EG004|Reported Event|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884816|NCT00485264|EG005|Reported Event|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
10884817|NCT00485303|BG000|Baseline|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
10884818|NCT00485303|FG000|Participant Flow|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
10884819|NCT00485303|OG000|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
10884820|NCT00485303|EG000|Reported Event|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
10884821|NCT00485433|BG000|Baseline|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
10884822|NCT00485433|BG001|Baseline|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
11225454|NCT02367885|BG002|Baseline|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
11225455|NCT02367885|BG003|Baseline|Total|Total of all reporting groups
10884823|NCT00485433|BG002|Baseline|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
10884824|NCT00485433|BG003|Baseline|SKY0402 High Dose|SKY0402 high dose given during hernia repair
10884825|NCT00485433|BG004|Baseline|Total|Total of all reporting groups
10884826|NCT00485433|FG000|Participant Flow|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
10884827|NCT00485433|FG001|Participant Flow|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
10884828|NCT00485433|FG002|Participant Flow|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
10884829|NCT00485433|FG003|Participant Flow|SKY0402 High Dose|SKY0402 high dose given during hernia repair
10884830|NCT00485433|OG000|Outcome|Bupivacaine HCl 105mg|A single dose of 105 mg bupivacaine in a 42-mL injection volume administered via local infiltration during surgery
10884831|NCT00485433|OG001|Outcome|SKY0402 Low Dose|A single dose of SKY0402 105mg diluted to a 42-mL injection volume administered via local infiltration during surgery
10884832|NCT00485433|OG002|Outcome|SKY0402 Middle Dose|A single dose of SKY0402 180mg diluted to a 42-mL injection volume administered via local infiltration during surgery
10884833|NCT00485433|OG003|Outcome|SKY0402 High Dose|A single dose of SKY0402 345 mg diluted to a 42-mL injection volume administered via local infiltration during surgery
10884834|NCT00485433|EG000|Reported Event|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
10884835|NCT00485433|EG001|Reported Event|SKY0402 (All Doses)|SKY0402 given during hernia repair
10884836|NCT00485472|BG000|Baseline|Lacosamide|Lacosamide (LCM) 400 mg/day
10884837|NCT00485472|BG001|Baseline|Placebo|Placebo
10884838|NCT00485472|BG002|Baseline|Total|Total of all reporting groups
10884839|NCT00485472|FG000|Participant Flow|Lacosamide|Lacosamide (LCM) 400 mg/day
10884840|NCT00485472|FG001|Participant Flow|Placebo|Placebo
10884841|NCT00485472|OG000|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
10884842|NCT00485472|OG001|Outcome|Placebo|Placebo
10884843|NCT00485472|EG000|Reported Event|Lacosamide|Lacosamide (LCM) 400 mg/day
10884844|NCT00485472|EG001|Reported Event|Placebo|Placebo
10884845|NCT00485485|BG000|Baseline|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
10884846|NCT00485485|FG000|Participant Flow|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
11225456|NCT02367885|FG000|Participant Flow|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
10884847|NCT00485485|OG000|Outcome|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
10884848|NCT00485485|EG000|Reported Event|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
10884849|NCT00485589|BG000|Baseline|Placebo|Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884850|NCT00485589|BG001|Baseline|Ocrelizumab 200 mg|Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884851|NCT00485589|BG002|Baseline|Ocrelizumab 500 mg|Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884852|NCT00485589|BG003|Baseline|Total|Total of all reporting groups
10884853|NCT00485589|FG000|Participant Flow|Placebo|Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884854|NCT00485589|FG001|Participant Flow|Ocrelizumab 200 mg|Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884855|NCT00485589|FG002|Participant Flow|Ocrelizumab 500 mg|Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884856|NCT00485589|OG000|Outcome|Placebo|Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884857|NCT00485589|OG001|Outcome|Ocrelizumab 200 mg|Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884858|NCT00485589|OG002|Outcome|Ocrelizumab 500 mg|Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
10884859|NCT00485589|EG000|Reported Event|Placebo - Treatment Period|Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884860|NCT00485589|EG001|Reported Event|Placebo/Ocrelizumab 500 mg - Treatment Period|Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884861|NCT00485589|EG002|Reported Event|Ocrelizumab 200 mg - Treatment Period|Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884862|NCT00485589|EG003|Reported Event|Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period|Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884863|NCT00485589|EG004|Reported Event|Ocrelizumab 500 mg - Treatment Period|Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884864|NCT00485589|EG005|Reported Event|Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period|Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884865|NCT00485589|EG006|Reported Event|Placebo - Safety Follow-up Period|Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10887213|NCT00499369|OG000|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887214|NCT00499369|OG001|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10884866|NCT00485589|EG007|Reported Event|Placebo/Ocrelizumab 500 mg - Safety Follow-up Period|Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884867|NCT00485589|EG008|Reported Event|Ocrelizumab 200 mg - Safety Follow-up Period|Participants had received Ocrelizumab intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884868|NCT00485589|EG009|Reported Event|Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period|Participants had received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884869|NCT00485589|EG010|Reported Event|Ocrelizumab 500 mg - Safety Follow-up Period|Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884870|NCT00485589|EG011|Reported Event|Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period|Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
10884871|NCT00485732|BG000|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
10884872|NCT00485732|BG001|Baseline|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
10884873|NCT00485732|BG002|Baseline|Total|Total of all reporting groups
10884874|NCT00485732|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
10884875|NCT00485732|FG001|Participant Flow|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
10884876|NCT00485732|OG000|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
10884877|NCT00485732|OG001|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
10884878|NCT00485732|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
10884879|NCT00485732|EG001|Reported Event|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
10884880|NCT00485758|BG000|Baseline|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
10884881|NCT00485758|BG001|Baseline|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
10884882|NCT00485758|BG002|Baseline|Total|Total of all reporting groups
10884883|NCT00485758|FG000|Participant Flow|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
10884884|NCT00485758|FG001|Participant Flow|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
10884885|NCT00485758|OG000|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
10884886|NCT00485758|OG001|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
10884887|NCT00485758|EG000|Reported Event|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
10884888|NCT00485758|EG001|Reported Event|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
10884889|NCT00485836|BG000|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
10884890|NCT00485836|BG001|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
11147775|NCT01859611|BG000|Baseline|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
11147776|NCT01859611|FG000|Participant Flow|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
11147777|NCT01859611|OG000|Outcome|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
11147778|NCT01859611|EG000|Reported Event|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
11147779|NCT01859637|BG000|Baseline|Zarzio®/Filgrastim HEXAL®|Open label single arm. All patients received Zarzio®/Filgrastim HEXAL® subcutaneously dosed as per recommendations in SmPC.
11147780|NCT01859637|FG000|Participant Flow|Zarzio®/Filgrastim HEXAL® (EP2006)|Open label single arm. All patients received Zarzio® subcutaneously dosed as per recommendations in Summary of Product Characteristics (SmPC).
11147781|NCT01859637|OG000|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
11147782|NCT01859637|EG000|Reported Event|Open-label Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
11147783|NCT01859702|BG000|Baseline|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
10884891|NCT00485836|BG002|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884892|NCT00485836|BG003|Baseline|Total|Total of all reporting groups
10884893|NCT00485836|FG000|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
10884894|NCT00485836|FG001|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884895|NCT00485836|FG002|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884896|NCT00485836|OG000|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
10884897|NCT00485836|OG001|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884898|NCT00485836|OG002|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884899|NCT00485836|EG000|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
10884900|NCT00485836|EG001|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
11147784|NCT01859702|FG000|Participant Flow|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
11147785|NCT01859702|OG000|Outcome|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
11147786|NCT01859702|EG000|Reported Event|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
11147787|NCT01859715|BG000|Baseline|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
10884901|NCT00485836|EG002|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884902|NCT00485953|BG000|Baseline|Active Medicine Group|risedronate 35 mg weekly
10884903|NCT00485953|BG001|Baseline|Placebo Group|Received placebo medication once per week
10884904|NCT00485953|BG002|Baseline|Total|Total of all reporting groups
10884905|NCT00485953|FG000|Participant Flow|Active Medication Group|"risedronate 35 mg weekly~risedronate: risedronate 35 mg per week"
10884906|NCT00485953|FG001|Participant Flow|Placebo Group|Received placebo medication once per week
10884907|NCT00485953|OG000|Outcome|Active Medicine Group|risedronate 35 mg weekly
10884908|NCT00485953|OG001|Outcome|Placebo Group|Received placebo medication once weekly
10884909|NCT00485953|OG000|Outcome|Active Medication Group|risedronate 35 mg weekly
10884910|NCT00485953|OG001|Outcome|Placebo Group|Placebo medication once weekly
10884911|NCT00485953|EG000|Reported Event|Active Medicine Group|risedronate 35 mg weekly
11147788|NCT01859715|BG001|Baseline|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
11147789|NCT01859715|BG002|Baseline|Nausea-observational Group|Patients given ondansetron for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
11147790|NCT01859715|BG003|Baseline|Total|Total of all reporting groups
10884912|NCT00485953|EG001|Reported Event|Placebo Group|Receive placebo medication once per week
10884913|NCT00486018|BG000|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
10884914|NCT00486018|BG001|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884915|NCT00486018|BG002|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884916|NCT00486018|BG003|Baseline|Total|Total of all reporting groups
10884917|NCT00486018|FG000|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
10884918|NCT00486018|FG001|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884919|NCT00486018|FG002|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884920|NCT00486018|OG000|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
10884921|NCT00486018|OG001|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884922|NCT00486018|OG002|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884923|NCT00486018|EG000|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
10884924|NCT00486018|EG001|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884925|NCT00486018|EG002|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
10884926|NCT00486031|BG000|Baseline|Balsalazide Disodium Tabs,3.3 g BID,|balsalazide disodium tablets,3.3 g BID,
10884927|NCT00486031|FG000|Participant Flow|Balsalazide Disodium Tabs,3.3 g BID|Balsalazide Disodium tablets,3.3 g BID
10884928|NCT00486031|OG000|Outcome|Balsalazide Disodium|balsalazide disodium tablets,3.3 g BID,
10884929|NCT00486031|OG000|Outcome|Balsalazide Disodium Tabs,3.3 g BID|Balsalazide Disodium tablets,3.3 g BID
10884930|NCT00486031|EG000|Reported Event|Balsalazide Disodium|balsalazide disodium tablets,3.3 g BID,
10884931|NCT00486044|BG000|Baseline|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
10884932|NCT00486044|BG001|Baseline|Placebo|Matching placebo tablet nightly for 9 months
10884933|NCT00486044|BG002|Baseline|Total|Total of all reporting groups
10884934|NCT00486044|FG000|Participant Flow|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
10884935|NCT00486044|FG001|Participant Flow|Placebo|Matching placebo tablet nightly for 9 months
10884936|NCT00486044|OG000|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
10884937|NCT00486044|OG001|Outcome|Placebo|Matching placebo tablet nightly for 9 months
10884938|NCT00486044|EG000|Reported Event|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
11147791|NCT01859715|FG000|Participant Flow|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
11147792|NCT01859715|FG001|Participant Flow|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
11147793|NCT01859715|FG002|Participant Flow|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
11147794|NCT01859715|OG000|Outcome|Oxycodone Group|Subjects given oxycodone 5mg mg by ED provider decision or by triage nurse randomization.
11147795|NCT01859715|OG001|Outcome|Hydrocodone/Acetaminophen Group|Subjects given or hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
11147796|NCT01859715|OG002|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
11147797|NCT01859715|OG000|Outcome|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
10884939|NCT00486044|EG001|Reported Event|Placebo|Matching placebo tablet nightly for 9 months
10884940|NCT00486226|BG000|Baseline|1 Endovascular|All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device and were consented before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
10884941|NCT00486226|FG000|Participant Flow|1 Endovascular|All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device (VRD). Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
10884942|NCT00486226|OG000|Outcome|1 Endovascular|All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
10884943|NCT00486226|OG000|Outcome|1 Endovascular|All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
10884944|NCT00486226|OG000|Outcome|Endovascular - Occlusion Results Immediately Post-procedure|Aneurysm occlusion was assessed immediately post procedure using the Raymond Scale.
10884945|NCT00486226|OG001|Outcome|Endovascular - Occlusion Results at 6 Months Follow-up|Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
10884946|NCT00486226|EG000|Reported Event|1 Endovascular|All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
10884947|NCT00486252|BG000|Baseline|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
10884948|NCT00486252|FG000|Participant Flow|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
10884949|NCT00486252|OG000|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
10884950|NCT00486252|OG001|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
10884951|NCT00486252|OG002|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
10884952|NCT00486252|EG000|Reported Event|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
10884953|NCT00486265|BG000|Baseline|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
10884954|NCT00486265|FG000|Participant Flow|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
11147798|NCT01859715|OG001|Outcome|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
11147799|NCT01859715|EG000|Reported Event|Oxycodone Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
10884955|NCT00486265|OG000|Outcome|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
10884956|NCT00486265|EG000|Reported Event|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
10884957|NCT00486278|BG000|Baseline|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
10884958|NCT00486278|FG000|Participant Flow|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
10884959|NCT00486278|OG000|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884960|NCT00486278|OG001|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884961|NCT00486278|OG002|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884962|NCT00486278|OG003|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884963|NCT00486278|OG004|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884964|NCT00486278|OG005|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
10884965|NCT00486278|EG000|Reported Event|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884966|NCT00486278|EG001|Reported Event|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884967|NCT00486278|EG002|Reported Event|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884968|NCT00486278|EG003|Reported Event|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884969|NCT00486278|EG004|Reported Event|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
10884970|NCT00486278|EG005|Reported Event|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
11147800|NCT01859715|EG001|Reported Event|Hydrocodone/Acetaminophen Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
11147801|NCT01859715|EG002|Reported Event|Nausea-observational Group|"Patients given ondansetron by ED provider decision or by triage nurse. This is an observational cohort only.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Ondansetron: Subjects given ondansetron for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only."
11150128|NCT01875874|FG000|Participant Flow|ELAD System (ELAD) Treatment Plus Standard of Care Treatment|"Continuous treatment with the ELAD System (ELAD) for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.~ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total)."
11150129|NCT01875874|OG000|Outcome|ELAD Treatment Plus Standard of Care Treatment|"Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.~ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total)."
11150130|NCT01875874|OG000|Outcome|ELAD System (ELAD) Treatment Plus Standard of Care Treatment|"Continuous treatment with the ELAD System (ELAD) for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.~ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total)."
11150131|NCT01875874|EG000|Reported Event|ELAD Treatment Plus Standard of Care Treatment|"Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.~ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total)."
11150132|NCT01875978|BG000|Baseline|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
11150133|NCT01875978|BG001|Baseline|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
11150134|NCT01875978|BG002|Baseline|Total|Total of all reporting groups
11150135|NCT01875978|FG000|Participant Flow|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
11150136|NCT01875978|FG001|Participant Flow|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
11150137|NCT01875978|OG000|Outcome|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
11150138|NCT01875978|OG001|Outcome|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
11150139|NCT01875978|OG000|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
11150140|NCT01875978|OG001|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
11150141|NCT01875978|EG000|Reported Event|Group A: Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2 weeks, then placebo for 4 weeks
10884971|NCT00486291|BG000|Baseline|Active|Phentermine 15mg/topiramate 100mg
10884972|NCT00486291|BG001|Baseline|Placebo|Matched placebo
10884973|NCT00486291|BG002|Baseline|Total|Total of all reporting groups
10884974|NCT00486291|FG000|Participant Flow|Active|Phentermine 15mg/topiramate 100mg
11150142|NCT01875978|EG001|Reported Event|Group B: Placebo-phytosterols|placebo for 4 weeks, washout 2 weeks. then daily 1.8 g phytosterols for 4 weeks
11150143|NCT01875991|BG000|Baseline|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
11150144|NCT01875991|BG001|Baseline|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
10884975|NCT00486291|FG001|Participant Flow|Placebo|Matched placebo
10884976|NCT00486291|OG000|Outcome|Active|Phentermine 15mg and topiramate 100mg
11150145|NCT01875991|BG002|Baseline|Total|Total of all reporting groups
11150146|NCT01875991|FG000|Participant Flow|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
11150147|NCT01875991|FG001|Participant Flow|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
11147802|NCT01859741|BG000|Baseline|P1B: OMP-59R5 5mg/kg + ETO + CIS|Cohort 1: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
11147803|NCT01859741|BG001|Baseline|P1B: OMP-59R5 7.5 mg/kg + ETO + CIS|Cohort 2: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10884977|NCT00486291|OG001|Outcome|Placebo|Matched placebo
10884978|NCT00486291|EG000|Reported Event|Active|Phentermine 15mg/topiramate 100mg
10884979|NCT00486291|EG001|Reported Event|Placebo|Matched placebo
10884980|NCT00486330|BG000|Baseline|Tipranavir/Ritonavir (500mg/200mg)|
10884981|NCT00486330|FG000|Participant Flow|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg (TPV/r) was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
10884982|NCT00486330|OG000|Outcome|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
10884983|NCT00486330|EG000|Reported Event|Tipranavir/Ritonavir (500mg/200mg)|
10884984|NCT00486434|BG000|Baseline|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
10884985|NCT00486434|BG001|Baseline|Placebo Arm|1 SMC021 Placebo tablet twice daily
10884986|NCT00486434|BG002|Baseline|Total|Total of all reporting groups
10884987|NCT00486434|FG000|Participant Flow|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
10884988|NCT00486434|FG001|Participant Flow|Placebo Arm|1 SMC021 Placebo tablet twice daily
10884989|NCT00486434|OG000|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
10884990|NCT00486434|OG001|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
11147804|NCT01859741|BG002|Baseline|P1B: OMP-59R5 10 mg/kg + ETO + CIS|Cohort 3: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3 and cisplatin 80 mg/m2 on Day 1).
11147805|NCT01859741|BG003|Baseline|P1B: OMP-59R5 12.5 mg/kg + ETO + CIS|Cohort 4: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10884991|NCT00486434|OG002|Outcome|Total|Total number of subjects between the two groups
10884992|NCT00486434|EG000|Reported Event|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
10884993|NCT00486434|EG001|Reported Event|Placebo Arm|1 SMC021 Placebo tablet twice daily
10884994|NCT00486447|BG000|Baseline|Imaging|"General imaging subjects receiving CT exams~64 Channel VCT: cardiac CT angiography exam"
10884995|NCT00486447|FG000|Participant Flow|Imaging|Enrolled subjects for general imaging
10884996|NCT00486447|OG000|Outcome|Enrolled|Enrolled subjects for general imaging
10884997|NCT00486447|OG000|Outcome|Outcome Measure 2|1 year clinical outcome follow-up (Study terminated prior to collection)
10884998|NCT00486447|EG000|Reported Event|Enrolled|Subjects receiving diagnostic CT scans
10884999|NCT00486525|BG000|Baseline|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
11147806|NCT01859741|BG004|Baseline|P1B: OMP-59R5 15 mg/kg + ETO + CIS|Cohort 5: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
11147807|NCT01859741|BG005|Baseline|P1B: OMP-59R5 15mg/kg + ETO + CARB|Cohort 6: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and carboplatin AUC of 5 mg/mL•min (Day 1).
11147808|NCT01859741|BG006|Baseline|P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB|Active Arm: Subjects receive OMP-59R5 15 mg/kg and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg *min
10885000|NCT00486525|BG001|Baseline|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
10885001|NCT00486525|BG002|Baseline|Total|Total of all reporting groups
10885002|NCT00486525|FG000|Participant Flow|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
10885003|NCT00486525|FG001|Participant Flow|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
10885004|NCT00486525|OG000|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
10885005|NCT00486525|OG001|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
10885006|NCT00486525|EG000|Reported Event|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
10885007|NCT00486525|EG001|Reported Event|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
10887215|NCT00499369|OG002|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887216|NCT00499369|OG003|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887217|NCT00499369|OG004|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
11147809|NCT01859741|BG007|Baseline|P2: Placebo + CIS or CARB|Placebo Arm: Active Arm: Subjects receive placebo and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg *min
11147810|NCT01859741|BG008|Baseline|Total|Total of all reporting groups
11147811|NCT01859741|FG000|Participant Flow|P1B: OMP-59R5 5mg/kg + ETO + CIS|Cohort 1: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10849296|NCT00295750|BG001|Baseline|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
10849297|NCT00295750|BG002|Baseline|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
10849298|NCT00295750|BG003|Baseline|Total|Total of all reporting groups
10849299|NCT00295750|FG000|Participant Flow|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
10849300|NCT00295750|FG001|Participant Flow|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
10849301|NCT00295750|FG002|Participant Flow|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
10849302|NCT00295750|OG000|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
10849303|NCT00295750|OG001|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
10849304|NCT00295750|OG002|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
10849305|NCT00295750|EG000|Reported Event|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
10849306|NCT00295750|EG001|Reported Event|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
10849307|NCT00295750|EG002|Reported Event|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
10849308|NCT00295854|BG000|Baseline|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
10849309|NCT00295854|BG001|Baseline|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
10849310|NCT00295854|BG002|Baseline|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
10849311|NCT00295854|BG003|Baseline|Total|Total of all reporting groups
10849312|NCT00295854|FG000|Participant Flow|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
10849313|NCT00295854|FG001|Participant Flow|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
10849314|NCT00295854|FG002|Participant Flow|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
10849315|NCT00295854|OG000|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
10885008|NCT00486603|BG000|Baseline|RT+TMZ+HCQ Phase 1|"Phse I: daily Hydroxychloroquine (HCQ) on 1st day of RT and concomitant TMZ for 6wks during RT. Starting dose of HCQ is 200mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. then every 4 weeks will be cycle of mono therapy of HCQ daily.~cohorts of three pts: dose levels: 200, 400, 600, 800mg. NO dose escalation beyond 800mg.~hydroxychloroquine: see arm description, the first 10 week cycle is call initiation cycle, Post the 10 week cycle of just HCQ, 4 week cycles are called Maintenance Cycles~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ TMZ days 1-5 150-20mg/m2 cycles 1-6~pharmacological study/Correlative study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation 6weeks during initiation cycle Monday - Friday"
10885009|NCT00486603|BG001|Baseline|RT+TMZ+HCQ Phase 2|"Daily hydroxychloroquine (HCQ) (MTD 600mg) on 1st day of RT and temozolomide for 6wks during RT. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle -Initiation Phase~Maintenance cycles 1-6 HCQ daily TMZ D 1-5 150-200mg/m2 every 28 days. Cycles 7+ mono therapy of HCQ daily, every 28 days.~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ TMZ D1-5 150-20mg/m2 cycles 1-6~pharmacological study/Correlative study: Seven samples in total collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation 6weeks during initiation cycle Monday - Friday~Pts will continue on treatment unti/tumor progression."
10885010|NCT00486603|BG002|Baseline|Total|Total of all reporting groups
10885011|NCT00486603|FG000|Participant Flow|RT+TMZ+HCQ Phase 1 - 200 mg|"Daily Hydroxchloroquine (HCQ) on 1st day of RT and TMZ for 6wks during RT. 200mg. After 6 wks, 4 wkd of HCQ alone daily. Complete 10 week cycle -Initiation Phase~Maintenance cycles 1-6 HCQ daily TMZ D 1-5 150-200mg/m2 every 28 days. Cycles 7+ mono therapy of HCQ daily, every 28 days.~Phse 2: same schema as above but at the prescribed MTD from Phse 1. PKs - correlatives will be collected in Phse 1 and Phse 2~hydroxychloroquine: see arm description, the first 10 week cycle is call initiation cycle, Post the 10 week cycle of just HCQ, 4 week cycles are called Maintenance Cycles~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study/Correlative study: Seven samples in total will be collected baseline, initiation cycle -wk3-4, wk9-10, Maintenance Cycle 1Week 4 (C1W4), C2W4, C3W4, C6W4"
10885012|NCT00486603|FG001|Participant Flow|RT+TMZ+HCQ Phase 1 - 400 mg|"Daily Hydroxchloroquine (HCQ) on 1st day of RT and TMZ for 6wks during RT. 400mg. After 6 wks, 4 wkd of HCQ alone daily. Complete 10 week cycle -Initiation Phase~Maintenance cycles 1-6 HCQ daily TMZ D 1-5 150-200mg/m2 every 28 days. Cycles 7+ mono therapy of HCQ daily, every 28 days.~Phse 2: same schema as above but at the prescribed MTD from Phse 1. PKs - correlatives will be collected in Phse 1 and Phse 2~hydroxychloroquine: see arm description, the first 10 week cycle is call initiation cycle, Post the 10 week cycle of just HCQ, 4 week cycles are called Maintenance Cycles~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study/Correlative study: Seven samples in total will be collected baseline, initiation cycle -wk3-4, wk9-10, Maintenance Cycle 1Week 4 (C1W4), C2W4, C3W4, C6W4"
10885013|NCT00486603|FG002|Participant Flow|RT+TMZ+HCQ Phase 1 - 600 mg|"Daily Hydroxchloroquine (HCQ) on 1st day of RT and TMZ for 6wks during RT. 600mg. After 6 wks, 4 wkd of HCQ alone daily. Complete 10 week cycle -Initiation Phase~Maintenance cycles 1-6 HCQ daily TMZ D 1-5 150-200mg/m2 every 28 days. Cycles 7+ mono therapy of HCQ daily, every 28 days.~Phse 2: same schema as above but at the prescribed MTD from Phse 1. PKs - correlatives will be collected in Phse 1 and Phse 2~hydroxychloroquine: see arm description, the first 10 week cycle is call initiation cycle, Post the 10 week cycle of just HCQ, 4 week cycles are called Maintenance Cycles~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study/Correlative study: Seven samples in total will be collected baseline, initiation cycle -wk3-4, wk9-10, Maintenance Cycle 1Week 4 (C1W4), C2W4, C3W4, C6W4"
10885014|NCT00486603|FG003|Participant Flow|RT+TMZ+HCQ Phase 1 - 800 mg|"Daily Hydroxchloroquine (HCQ) on 1st day of RT and TMZ for 6wks during RT. 800mg. After 6 wks, 4 wkd of HCQ alone daily. Complete 10 week cycle -Initiation Phase~Maintenance cycles 1-6 HCQ daily TMZ D 1-5 150-200mg/m2 every 28 days. Cycles 7+ mono therapy of HCQ daily, every 28 days.~Phse 2: same schema as above but at the prescribed MTD from Phse 1. PKs - correlatives will be collected in Phse 1 and Phse 2~hydroxychloroquine: see arm description, the first 10 week cycle is call initiation cycle, Post the 10 week cycle of just HCQ, 4 week cycles are called Maintenance Cycles~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study/Correlative study: Seven samples in total will be collected baseline, initiation cycle -wk3-4, wk9-10, Maintenance Cycle 1Week 4 (C1W4), C2W4, C3W4, C6W4"
10885015|NCT00486603|FG004|Participant Flow|RT+TMZ+HCQ Phase 2 - MTD 600 mg|"Phse 2: daily hydroxychloroquine (HCQ) (MTD 600mg) on 1st day of RT and concomitant temozolomide for 6wks during RT. After 6 wks, 4 wkd of HCQ alone daily. After 6 wks, 4 wkd of HCQ alone daily. Complete 10 week cycle -Initiation Phase~Maintenance cycles 1-6 HCQ daily TMZ D 1-5 150-200mg/m2 every 28 days. Cycles 7+ mono therapy of HCQ daily, every 28 days.~Pts will continue on treatment unitl tumor progression. PKs - correlatives will be collected in Phse 2~Radiation"
10885016|NCT00486603|OG000|Outcome|Phase 1 - Dose Finding|"Phse I: daily Hydroxychloroquine (HCQ) on 1st day of RT and concomitant TMZ for 6wks during RT. Starting dose of HCQ is 200mg. After 6 wks, 4 wkd of HCQ alone daily. Complete 10 week cycle -Initiation Phase~Maintenance cycles 1-6 HCQ daily TMZ D 1-5 150-200mg/m2 every 28 days. Cycles 7+ mono therapy of HCQ daily, every 28 days.~cohorts of three pts: dose levels: 200, 400, 600mg 800mg. NO dose escalation beyond 800mg.~temozolomide: TMZ daily 75mg/m2 for 6weeks with RT+HCQ TMZ Maintenance cycle 1-6 150-200mg/m2~pharmacological study/Correlative study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4 (C2W4), Cycle3 Week4 (C3W4), Cycle6 Week4 (C6W4)~Radiation 6weeks during initation cycle Monday - Friday"
10885017|NCT00486603|OG000|Outcome|Phase 1: RT+TMZ+HCQ - 200mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 200mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10849406|NCT00296140|OG001|Outcome|Screening and Treatment of PSD|Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
10849407|NCT00296140|EG000|Reported Event|Self Management of PSD Symptoms|Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.
10849408|NCT00296140|EG001|Reported Event|Screening and Treatment of PSD|Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
10849409|NCT00296192|BG000|Baseline|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
10849410|NCT00296192|BG001|Baseline|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
10849411|NCT00296192|BG002|Baseline|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
10849412|NCT00296192|BG003|Baseline|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
10849413|NCT00296192|BG004|Baseline|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
10849414|NCT00296192|BG005|Baseline|Total|Total of all reporting groups
10849415|NCT00296192|FG000|Participant Flow|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
10849416|NCT00296192|FG001|Participant Flow|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
10849417|NCT00296192|FG002|Participant Flow|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
10849418|NCT00296192|FG003|Participant Flow|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
10849419|NCT00296192|FG004|Participant Flow|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
10849420|NCT00296192|OG000|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
10849421|NCT00296192|OG001|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
10849422|NCT00296192|OG002|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
10849423|NCT00296192|OG003|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
10849424|NCT00296192|OG004|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
10849425|NCT00296192|EG000|Reported Event|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
10849426|NCT00296192|EG001|Reported Event|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
10849427|NCT00296192|EG002|Reported Event|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
10849428|NCT00296192|EG003|Reported Event|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
10849429|NCT00296192|EG004|Reported Event|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
10849430|NCT00296231|BG000|Baseline|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
10849431|NCT00296231|FG000|Participant Flow|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
10849432|NCT00296231|OG000|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
10849433|NCT00296231|EG000|Reported Event|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
10849434|NCT00296244|BG000|Baseline|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
10849435|NCT00296244|BG001|Baseline|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
10849436|NCT00296244|BG002|Baseline|Total|Total of all reporting groups
10849437|NCT00296244|FG000|Participant Flow|Control Group|Control group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)with steroids
10849438|NCT00296244|FG001|Participant Flow|Study Group|Study group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)
10849439|NCT00296244|OG000|Outcome|Control Group|Control group-basiliximab, tacrolimus, EC-MPA, steroids
10849440|NCT00296244|OG001|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
10849441|NCT00296244|OG000|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
10849442|NCT00296244|OG001|Outcome|Study Group|Study group -basiliximab, tacrolimus, EC-MPA
10849443|NCT00296244|OG000|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
10849444|NCT00296244|OG000|Outcome|Control Group|Control group- basiliximab, tacrolimus, EC-MPA, steroids
10849445|NCT00296244|OG001|Outcome|Study Group|Study group - basiliximab, tacrolimus, EC-MPA
10849446|NCT00296244|EG000|Reported Event|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
10849447|NCT00296244|EG001|Reported Event|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
10849448|NCT00296296|BG000|Baseline|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
10849449|NCT00296296|BG001|Baseline|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
10849450|NCT00296296|BG002|Baseline|Total|Total of all reporting groups
10885018|NCT00486603|OG001|Outcome|Phase 1: RT+TMZ+HCQ - 400mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 400mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885019|NCT00486603|OG002|Outcome|Phase 1: RT+TMZ+HCQ - 600mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 600mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885020|NCT00486603|OG003|Outcome|Phase 1: RT+TMZ+HCQ - 800mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 800mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885021|NCT00486603|OG000|Outcome|Phase 2: RT + TMZ + HCQ|"Daily hydroxychloroquine (HCQ) (MTD 600mg) on 1st day of RT and concomitant temozolomide for 6wks during RT. After 6 weeks, 4 weeks of HCQ alone daily. Complete 10 week cycle -Initiation Phase~Maintenance cycles 1-6 HCQ daily TMZ D 1-5 150-200mg/m2 every 28 days. Cycles 7+ mono therapy of HCQ daily, every 28 days.~Other: pharmacological study (PK)~Pts will continue on treatment until tumor progression.~PKs - correlatives will be collected in Phase 2~Radiation (RT)~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885022|NCT00486603|OG000|Outcome|HCQ Cmax <= 1785 ng/mL|"Participants from Phase I and II with a HCQ Cmax <= 1785 ng/mL~Cmax calculated based on 7 samples collected (baseline, initiation Cycle(C) W3-4, W9-10, Maintenance C1W4, C2W4, C3W4, C6W4)"
10885023|NCT00486603|OG001|Outcome|HCQ Cmax>1785 ng/mL|"Participants from Phase I and II with a HCQ Cmax>1785 ng/mL~Cmax calculated based on 7 samples collected (baseline, initiation Cycle(C) W3-4, W9-10, Maintenance C1W4, C2W4, C3W4, C6W4)"
10885024|NCT00486603|EG000|Reported Event|Phase 1: RT+TMZ+HCQ - 200mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 200mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885025|NCT00486603|EG001|Reported Event|Phase 1: RT+TMZ+HCQ - 400mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 400mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885026|NCT00486603|EG002|Reported Event|Phase 1: RT+TMZ+HCQ - 600mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 600mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885027|NCT00486603|EG003|Reported Event|Phase 1: RT+TMZ+HCQ - 800mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 800mg. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885028|NCT00486603|EG004|Reported Event|Phase 2: RT+TMZ+HCQ - MTD 600mg|"Daily hydroxychloroquine (HCQ) on 1st day of RT and concomitant temozolomide for 6wks during RT. Dose of HCQ is 600mg MTD. After 6 wks, 4 wkd of HCQ alone daily. this will complete 10 week cycle. -Initiation Phase~temozolomide: TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)~pharmacological study: Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4~Radiation: Radiation during the first six weeks of treatment Monday-Friday"
10885029|NCT00486642|BG000|Baseline|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885030|NCT00486642|BG001|Baseline|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885031|NCT00486642|BG002|Baseline|Total|Total of all reporting groups
10885032|NCT00486642|FG000|Participant Flow|Arm I (Pazopanib)|"Arm I - Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885033|NCT00486642|FG001|Participant Flow|Arm II (Pazopanib & Bicalutamide)|Arm II - Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
10885034|NCT00486642|OG000|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885035|NCT00486642|OG001|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885036|NCT00486642|OG000|Outcome|Arm A (Pazopanib)|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885037|NCT00486642|OG001|Outcome|Arm B (Pazopanib + Bicalutamide)|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885038|NCT00486642|EG000|Reported Event|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885039|NCT00486642|EG001|Reported Event|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
10885040|NCT00486720|BG000|Baseline|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
10885041|NCT00486720|BG001|Baseline|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
10885042|NCT00486720|BG002|Baseline|Total|Total of all reporting groups
10885043|NCT00486720|FG000|Participant Flow|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
10885044|NCT00486720|FG001|Participant Flow|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
10885045|NCT00486720|OG000|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
10885046|NCT00486720|OG001|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
10885047|NCT00486720|EG000|Reported Event|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
10885048|NCT00486720|EG001|Reported Event|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
10885049|NCT00486759|BG000|Baseline|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
10885050|NCT00486759|BG001|Baseline|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
10885051|NCT00486759|BG002|Baseline|Total|Total of all reporting groups
10885052|NCT00486759|FG000|Participant Flow|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
11225457|NCT02367885|FG001|Participant Flow|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
10885053|NCT00486759|FG001|Participant Flow|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
10885054|NCT00486759|OG000|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
10885055|NCT00486759|OG001|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
10885056|NCT00486759|EG000|Reported Event|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
10885057|NCT00486759|EG001|Reported Event|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
10885058|NCT00486811|BG000|Baseline|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
10885059|NCT00486811|BG001|Baseline|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
10885060|NCT00486811|BG002|Baseline|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
10885061|NCT00486811|BG003|Baseline|Total|Total of all reporting groups
10885062|NCT00486811|FG000|Participant Flow|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
10885063|NCT00486811|FG001|Participant Flow|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
10885064|NCT00486811|FG002|Participant Flow|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
10885065|NCT00486811|OG000|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
10885066|NCT00486811|OG001|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
10885067|NCT00486811|OG002|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
10885068|NCT00486811|EG000|Reported Event|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
10885069|NCT00486811|EG001|Reported Event|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
10885070|NCT00486811|EG002|Reported Event|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
10885071|NCT00486824|BG000|Baseline|Indomethacin|"50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.~Indomethacin: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs."
10885072|NCT00486824|BG001|Baseline|Nifedipine|"30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.~Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs."
10885073|NCT00486824|BG002|Baseline|Total|Total of all reporting groups
10885074|NCT00486824|FG000|Participant Flow|Indomethacin|"50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.~Indomethacin: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs."
10885075|NCT00486824|FG001|Participant Flow|Nifedipine|"30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.~Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs."
10885076|NCT00486824|OG000|Outcome|Indomethacin|"50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.~Indomethacin: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs."
10885077|NCT00486824|OG001|Outcome|Nifedipine|"30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.~Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs."
11150148|NCT01875991|OG000|Outcome|Primary Analysis Set|Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
11150149|NCT01875991|OG000|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
10885078|NCT00486824|EG000|Reported Event|Indomethacin|"50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.~Indomethacin: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs."
10885079|NCT00486824|EG001|Reported Event|Nifedipine|"30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.~Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs."
10885080|NCT00486837|BG000|Baseline|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
10885081|NCT00486837|BG001|Baseline|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
10885082|NCT00486837|BG002|Baseline|Total|Total of all reporting groups
10885083|NCT00486837|FG000|Participant Flow|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
10885084|NCT00486837|FG001|Participant Flow|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
10885085|NCT00486837|OG000|Outcome|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
10885086|NCT00486837|OG001|Outcome|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
10885087|NCT00486837|OG000|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
10885088|NCT00486837|OG001|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
10885089|NCT00486837|EG000|Reported Event|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
10885090|NCT00486837|EG001|Reported Event|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
10885091|NCT00486863|BG000|Baseline|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
10885092|NCT00486863|BG001|Baseline|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
10885093|NCT00486863|BG002|Baseline|Total|Total of all reporting groups
10885094|NCT00486863|FG000|Participant Flow|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules as the test agent, but with the inert compound dextrose.
10885095|NCT00486863|FG001|Participant Flow|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours. The agent was gel encapsulated to reduce appreciation of odor and taste and mimic appearance of the placebo.
10885096|NCT00486863|OG000|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
10885097|NCT00486863|OG001|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
10885098|NCT00486863|OG000|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
11150150|NCT01875991|OG001|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
11150151|NCT01875991|OG000|Outcome|Autoinjector A Preference|Participants who preferred Autoinjector A overall
11150152|NCT01875991|OG001|Outcome|Autoinjector B Preference|Participants who preferred Autoinjector B overall
11150153|NCT01875991|EG000|Reported Event|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
11150154|NCT01875991|EG001|Reported Event|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
11150155|NCT01876043|BG000|Baseline|Plitidepsin|"plitidepsin~plitidepsin"
11150156|NCT01876043|FG000|Participant Flow|Plitidepsin|"Patients received Aplidin® as an i.v. 3-h infusion of 5 mg/m2/day on days 1 and 15 every 4 weeks (q4wk).Patients discontinued Aplidin if one of the following occurred: consent withdrawal, unacceptable toxicity, disease progression (RECIST v1.1), intercurrent illness or investigator's decision.~Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 37 evaluable patients (first stage: 17 patients) used to distinguish a favorable true non-progression rate of 40% from a null rate of 20% (90% power and 10% type I error).~Stage 1(17 participants): if <=3 non-progressions at 3 months, the study was stopped early. Otherwise, the second group of 20 participants was recruited.~Stage 2 (37 participants): if >= 11 non-progressions, Aplidin was considered promising."
11150157|NCT01876043|OG000|Outcome|Plitidepsin|"plitidepsin~plitidepsin"
11150158|NCT01876043|EG000|Reported Event|Plitidepsin|"plitidepsin~plitidepsin"
11150159|NCT01876082|BG000|Baseline|PAZOPANIB|"Pazopanib~800 mg per day~oral administration~at least 1 hour before or 2 hours after a meal,~until disease progression or for 12 months maximum~PAZOPANIB treatment: Pazopanib~800 mg per day~oral administration~at least 1 hour before or 2 hours after a meal,~until disease progression or for 12 months maximum"
11150160|NCT01876082|BG001|Baseline|Vinblastine and Methotrexate|"vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.~Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months."
11150161|NCT01876082|BG002|Baseline|Total|Total of all reporting groups
10885099|NCT00486863|EG000|Reported Event|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
10885100|NCT00486863|EG001|Reported Event|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
10885101|NCT00486902|BG000|Baseline|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
10885102|NCT00486902|BG001|Baseline|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
10885103|NCT00486902|BG002|Baseline|Total|Total of all reporting groups
10885104|NCT00486902|FG000|Participant Flow|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
10885105|NCT00486902|FG001|Participant Flow|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
10885106|NCT00486902|OG000|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
10885107|NCT00486902|OG001|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
10885108|NCT00486902|EG000|Reported Event|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
10885109|NCT00486902|EG001|Reported Event|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
10885110|NCT00486954|BG000|Baseline|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
10885111|NCT00486954|BG001|Baseline|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
10885112|NCT00486954|BG002|Baseline|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
10885113|NCT00486954|BG003|Baseline|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
10885114|NCT00486954|BG004|Baseline|Total|Total of all reporting groups
10885115|NCT00486954|FG000|Participant Flow|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
10885116|NCT00486954|FG001|Participant Flow|Lapatinib Plus Paclitaxel in Partial Gastrectomy Participants|Participants with partial gastrectomy (which includes preservation of the pylorus) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Partial gastrectomy (pylorus preserved) is very rare population in Japan. As a result, no such participants were recruited into this cohort.
10885117|NCT00486954|FG002|Participant Flow|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
10885118|NCT00486954|FG003|Participant Flow|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
10885119|NCT00486954|FG004|Participant Flow|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
10885120|NCT00486954|OG000|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
10885121|NCT00486954|OG001|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
10885122|NCT00486954|OG000|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
10885123|NCT00486954|OG001|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
10885124|NCT00486954|EG000|Reported Event|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
10885125|NCT00486954|EG001|Reported Event|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
10885126|NCT00486954|EG002|Reported Event|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
10885127|NCT00486954|EG003|Reported Event|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
10885128|NCT00487084|BG000|Baseline|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
10885129|NCT00487084|BG001|Baseline|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
10885130|NCT00487084|BG002|Baseline|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
10885131|NCT00487084|BG003|Baseline|Total|Total of all reporting groups
10885132|NCT00487084|FG000|Participant Flow|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
10885133|NCT00487084|FG001|Participant Flow|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
10885134|NCT00487084|FG002|Participant Flow|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
10885135|NCT00487084|OG000|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
10885136|NCT00487084|OG001|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
10885137|NCT00487084|OG002|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
10885138|NCT00487084|EG000|Reported Event|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
10885139|NCT00487084|EG001|Reported Event|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
10885140|NCT00487084|EG002|Reported Event|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
10885141|NCT00487188|BG000|Baseline|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
10885142|NCT00487188|BG001|Baseline|HAART|Participants received highly active antiretroviral treatment.
10885143|NCT00487188|BG002|Baseline|Total|Total of all reporting groups
10885144|NCT00487188|FG000|Participant Flow|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
10885145|NCT00487188|FG001|Participant Flow|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
10885146|NCT00487188|FG002|Participant Flow|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
10885147|NCT00487188|OG000|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
10885148|NCT00487188|OG001|Outcome|HAART|Participants received highly active antiretroviral treatment.
10885149|NCT00487188|OG000|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who were randomized to ENF+HAART at BL1 and follows the patients throughout 48 weeks, regardless of which arm they were randomized to at BL2."
10885150|NCT00487188|OG001|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
10885151|NCT00487188|OG000|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
10885152|NCT00487188|OG000|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
10885153|NCT00487188|OG000|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
10885154|NCT00487188|OG001|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
10885155|NCT00487188|OG002|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
10885156|NCT00487188|EG000|Reported Event|Induction: ENF+HAART|During the Induction Phase participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for a maximum of 32 weeks.
10885157|NCT00487188|EG001|Reported Event|Induction Phase: HAART|During the Induction Phase participants received highly active antiretroviral treatment for a maximum of 32 weeks.
10885158|NCT00487188|EG002|Reported Event|Maintenance Phase: ENF + HAART|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for up to 48 weeks of total treatment.
10885159|NCT00487188|EG003|Reported Event|Maintenance Phase: HAART (ENF Removed)|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive HAART alone during the Maintenance Phase, for up to a total of 48 weeks treatment.
10885160|NCT00487188|EG004|Reported Event|Maintenance Phase: HAART|During the Maintenance Phase, participants who had received HAART alone and who responded to treatment during the Induction Phase continued to receive highly active antiretroviral treatment for up to 48 weeks of total treatment.
10885161|NCT00487240|BG000|Baseline|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
10885162|NCT00487240|BG001|Baseline|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
10885163|NCT00487240|BG002|Baseline|Total|Total of all reporting groups
10885164|NCT00487240|FG000|Participant Flow|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
10885165|NCT00487240|FG001|Participant Flow|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
10885166|NCT00487240|OG000|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
10885167|NCT00487240|OG001|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
11147812|NCT01859741|FG001|Participant Flow|P1B: OMP-59R5 7.5 mg/kg + ETO + CIS|Cohort 2: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10885168|NCT00487240|EG000|Reported Event|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
11147813|NCT01859741|FG002|Participant Flow|P1B: OMP-59R5 10 mg/kg + ETO + CIS|Cohort 3: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3 and cisplatin 80 mg/m2 on Day 1).
11147814|NCT01859741|FG003|Participant Flow|P1B: OMP-59R5 12.5 mg/kg + ETO + CIS|Cohort 4: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10885169|NCT00487240|EG001|Reported Event|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
10885170|NCT00487279|BG000|Baseline|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
10885171|NCT00487279|BG001|Baseline|Control Group|Medical therapy alone
10885172|NCT00487279|BG002|Baseline|Total|Total of all reporting groups
10885173|NCT00487279|FG000|Participant Flow|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
10885174|NCT00487279|FG001|Participant Flow|Control Group|Medical therapy alone
10885175|NCT00487279|OG000|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
10885176|NCT00487279|OG001|Outcome|Control Group|Medical therapy alone
10885177|NCT00487279|EG000|Reported Event|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
10885178|NCT00487279|EG001|Reported Event|Control Group|Medical therapy alone
10885179|NCT00487396|BG000|Baseline|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested.The purpose was to detect patients with Crohn's Disease. Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
10885180|NCT00487396|FG000|Participant Flow|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
10885181|NCT00487396|OG000|Outcome|PillCam SB Followed by Ileo Colonoscopy|Ingestible capsule equipped with an endoscope with one imagers, before ileo-colonoscopy.
10885182|NCT00487396|OG001|Outcome|Small Bowel Follow Through (SBFT) and Ileo-colonoscopy|Following ingestible capsule, same patients also underwent ileo-colonoscopy (IC) and small bowel follow through (SBFT).
10885183|NCT00487396|OG000|Outcome|Pill Cam SB Capsule (CE)|Capsule endoscopy was ingested. The purpose was to detect patients with crohn's disease. Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
10885184|NCT00487396|OG001|Outcome|Small Bowel Follow Through (SBFT)|Capsule endoscopy was ingested. The purpose was to detect patients with crohn's disease. Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
10885185|NCT00487396|OG000|Outcome|PillCam SB Capsule|Capsule endoscopy was ingested.The purpose was to detect patients with crohn's disease. Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
10885186|NCT00487396|OG001|Outcome|Standard Ileocolonoscopy (IC)|Capsule endoscopy was ingested.The purpose was to detect patients with crohn's disease. Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
10885187|NCT00487396|EG000|Reported Event|Adverse Events|All subjects received both the capsule endoscopy procedure and the ileocolonoscopy procedure
10885188|NCT00487435|BG000|Baseline|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
10885189|NCT00487435|FG000|Participant Flow|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
11147815|NCT01859741|FG004|Participant Flow|P1B: OMP-59R5 15 mg/kg + ETO + CIS|Cohort 5: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10885190|NCT00487435|OG000|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
10885191|NCT00487435|EG000|Reported Event|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
10885192|NCT00487539|BG000|Baseline|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
10885193|NCT00487539|BG001|Baseline|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
10885194|NCT00487539|BG002|Baseline|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
10885195|NCT00487539|BG003|Baseline|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
10885196|NCT00487539|BG004|Baseline|Total|Total of all reporting groups
10885197|NCT00487539|FG000|Participant Flow|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
10885198|NCT00487539|FG001|Participant Flow|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
10885199|NCT00487539|FG002|Participant Flow|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
11009906|NCT01104584|BG000|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
10885200|NCT00487539|FG003|Participant Flow|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
10885201|NCT00487539|OG000|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
10885202|NCT00487539|OG001|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
10885203|NCT00487539|OG002|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
10885204|NCT00487539|EG000|Reported Event|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
10885205|NCT00487539|EG001|Reported Event|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
10885206|NCT00487539|EG002|Reported Event|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
10885207|NCT00487539|EG003|Reported Event|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
10885208|NCT00487552|BG000|Baseline|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
10885209|NCT00487552|FG000|Participant Flow|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
10885210|NCT00487552|OG000|Outcome|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
10885211|NCT00487552|OG000|Outcome|Magnetic Anastomosis Device (MAD)|Magnetic Anastomosis Device (MAD) used for palliative treatment of gastric outlet obstruction.
10885212|NCT00487552|EG000|Reported Event|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
10885213|NCT00487565|BG000|Baseline|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
10885214|NCT00487565|FG000|Participant Flow|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
10885215|NCT00487565|OG000|Outcome|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
10885216|NCT00487565|EG000|Reported Event|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
10885217|NCT00487669|BG000|Baseline|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
11147816|NCT01859741|FG005|Participant Flow|P1B: OMP-59R5 15mg/kg + ETO + CARB|Cohort 6: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and carboplatin AUC of 5 mg/mL•min (Day 1).
10885218|NCT00487669|FG000|Participant Flow|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
10885219|NCT00487669|OG000|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
10885220|NCT00487669|OG001|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
10885221|NCT00487669|EG000|Reported Event|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
10885222|NCT00487669|EG001|Reported Event|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
10885223|NCT00487695|BG000|Baseline|All Study Participants|Patients received both procedures (CLE and standard EGD), so baseline characteristics are reported for the group
10885224|NCT00487695|FG000|Participant Flow|CLE Followed by Standard EGD|Patients randomized to either CLE or standard endoscopy first. The other procedure was then performed 6 weeks later. This group was randomized to CLE first, followed by standard endoscopy
10885225|NCT00487695|FG001|Participant Flow|Standard EGD Followed by CLE|Patients in this group were randomized to have standard EGD followed by CLE 6 weeks later
10885226|NCT00487695|OG000|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
10885227|NCT00487695|OG001|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
11009907|NCT01104584|FG000|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
11009908|NCT01104584|OG000|Outcome|CMRM Versus UMRM|
11009909|NCT01104584|OG000|Outcome|CMRM|
11009910|NCT01104584|OG001|Outcome|UMRM|
11009911|NCT01104584|OG001|Outcome|CMRM vs XRM|
11009912|NCT01104584|OG002|Outcome|CMRM vs CMRM+XRM|
11009913|NCT01104584|OG001|Outcome|CMRM+XRM vs UMRM+XRM|
11009914|NCT01104584|OG002|Outcome|CMRM+XRM vs XRM|
11009915|NCT01104584|OG000|Outcome|X-ray Mammography (XRM)|
11009916|NCT01104584|OG001|Outcome|CMRM+XRM|
11009917|NCT01104584|OG002|Outcome|UMRM+XRM|
11009918|NCT01104584|OG000|Outcome|UMRM|
11009919|NCT01104584|OG001|Outcome|X-ray Mammography (XRM)|
11009920|NCT01104584|OG002|Outcome|CMRM+XRM|
11009921|NCT01104584|OG003|Outcome|UMRM+XRM|
11009922|NCT01104584|OG001|Outcome|CMRM|
10885228|NCT00487695|EG000|Reported Event|Confocal Laser Endomicroscopy|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
10885229|NCT00487695|EG001|Reported Event|Standard EGD|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
10885230|NCT00487721|BG000|Baseline|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
10885231|NCT00487721|BG001|Baseline|Control|Subjects in the control arm did not receive any treatment or placebo.
10885232|NCT00487721|BG002|Baseline|Total|Total of all reporting groups
10885233|NCT00487721|FG000|Participant Flow|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
10885234|NCT00487721|FG001|Participant Flow|Control|Subjects in the control arm did not receive any treatment or placebo.
10885235|NCT00487721|OG000|Outcome|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
10885236|NCT00487721|EG000|Reported Event|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
10885237|NCT00487721|EG001|Reported Event|Control|Subjects in the control arm did not receive any treatment or placebo.
11009923|NCT01104584|OG002|Outcome|X-ray Mammography (XRM)|
11009924|NCT01104584|OG004|Outcome|CMRM+XRM|
11009925|NCT01104584|OG000|Outcome|CMRM vs UMRM|
11009926|NCT01104584|OG000|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
11009927|NCT01104584|EG000|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
10885238|NCT00487747|BG000|Baseline|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
10885239|NCT00487747|FG000|Participant Flow|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a [Pegasys], 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
10885240|NCT00487747|OG000|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
10885241|NCT00487747|EG000|Reported Event|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
10885242|NCT00487825|BG000|Baseline|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
10885243|NCT00487825|BG001|Baseline|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
10885244|NCT00487825|BG002|Baseline|Total|Total of all reporting groups
10885245|NCT00487825|FG000|Participant Flow|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
10885246|NCT00487825|FG001|Participant Flow|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
10885247|NCT00487825|OG000|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
10885248|NCT00487825|OG001|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
10885249|NCT00487825|EG000|Reported Event|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
10885250|NCT00487825|EG001|Reported Event|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
10885251|NCT00487942|BG000|Baseline|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
11009928|NCT01104636|BG000|Baseline|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
10885252|NCT00487942|BG001|Baseline|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
10885253|NCT00487942|BG002|Baseline|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
10885254|NCT00487942|BG003|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
10885255|NCT00487942|BG004|Baseline|Total|Total of all reporting groups
10885256|NCT00487942|FG000|Participant Flow|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
10885257|NCT00487942|FG001|Participant Flow|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
10885258|NCT00487942|FG002|Participant Flow|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
10885259|NCT00487942|FG003|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
10885260|NCT00487942|OG000|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
10885261|NCT00487942|OG001|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
10885262|NCT00487942|OG002|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
10885263|NCT00487942|OG003|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
10885264|NCT00487942|EG000|Reported Event|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
10885265|NCT00487942|EG001|Reported Event|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
11009929|NCT01104636|FG000|Participant Flow|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
11225458|NCT02367885|FG002|Participant Flow|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
10885266|NCT00487942|EG002|Reported Event|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
10885267|NCT00487942|EG003|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
10885268|NCT00488033|BG000|Baseline|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
10885269|NCT00488033|BG001|Baseline|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
10885270|NCT00488033|BG002|Baseline|Total|Total of all reporting groups
10885271|NCT00488033|FG000|Participant Flow|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
10885272|NCT00488033|FG001|Participant Flow|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
11009930|NCT01104636|OG000|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
11009931|NCT01104636|EG000|Reported Event|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
11009932|NCT01104662|BG000|Baseline|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
11009933|NCT01104662|BG001|Baseline|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009934|NCT01104662|BG002|Baseline|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
11067052|NCT01394978|EG002|Reported Event|ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure|"ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).~Progel Pleural Air Leak Sealant without standard surgical closure (standard closure with, sutures or staples, for example)."
10885273|NCT00488033|OG000|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
10885274|NCT00488033|OG001|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
10885275|NCT00488033|EG000|Reported Event|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
10885276|NCT00488033|EG001|Reported Event|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
10885277|NCT00488059|BG000|Baseline|Phase 1: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
10885278|NCT00488059|FG000|Participant Flow|Phase I|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
10885279|NCT00488059|FG001|Participant Flow|Phase II - Arm A|Phase I then enfuvirtide 90 mg SC BID + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
10885280|NCT00488059|FG002|Participant Flow|Phase II - Arm B|Phase I then enfuvirtide 180 mg SC QD (2 x 90-mg injections) + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
10885281|NCT00488059|OG000|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
10885282|NCT00488059|OG000|Outcome|Phase II Arm A: Phase I Then ENF 90 mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I+ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
10885283|NCT00488059|OG001|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
10885284|NCT00488059|OG000|Outcome|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
10885285|NCT00488059|OG000|Outcome|Phase II Arm A: Phase I Then ENF 90mg BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
10885286|NCT00488059|OG001|Outcome|Phase II Arm B: Phase I Then ENF 180mg QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
11147817|NCT01859741|FG006|Participant Flow|P2: Placebo + CIS or CARB|Placebo Arm: Active Arm: Subjects receive placebo and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg *min
10885287|NCT00488059|OG001|Outcome|Phase II - Arm A|Phase I then ENF 90 mg SC BID
10885288|NCT00488059|OG002|Outcome|Phase II - Arm B|Phase I then ENF 180 mg SC QD
10885289|NCT00488059|EG000|Reported Event|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
11147818|NCT01859741|FG007|Participant Flow|P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB|Active Arm: Subjects receive OMP-59R5 15 mg/kg and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg *min
10885290|NCT00488059|EG001|Reported Event|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
10885291|NCT00488059|EG002|Reported Event|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized~(Phase II Arm B: Phase I then ENF 180mg SC once daily (QD)): ENF 180 mg SC QD + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
10885292|NCT00488293|BG000|Baseline|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
10885293|NCT00488293|BG001|Baseline|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
10885294|NCT00488293|BG002|Baseline|Total|Total of all reporting groups
10885295|NCT00488293|FG000|Participant Flow|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
10885296|NCT00488293|FG001|Participant Flow|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
10885297|NCT00488293|OG000|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
10885298|NCT00488293|OG001|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
10885299|NCT00488293|EG000|Reported Event|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
10885300|NCT00488293|EG001|Reported Event|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
10885301|NCT00488319|BG000|Baseline|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885302|NCT00488319|BG001|Baseline|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885303|NCT00488319|BG002|Baseline|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885304|NCT00488319|BG003|Baseline|Total|Total of all reporting groups
10885305|NCT00488319|FG000|Participant Flow|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885306|NCT00488319|FG001|Participant Flow|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
11067053|NCT01394991|BG000|Baseline|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
11067054|NCT01394991|BG001|Baseline|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
11067055|NCT01394991|BG002|Baseline|Total|Total of all reporting groups
11067056|NCT01394991|FG000|Participant Flow|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
11067057|NCT01394991|FG001|Participant Flow|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
11067058|NCT01394991|OG000|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
11067059|NCT01394991|OG001|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
10885307|NCT00488319|FG002|Participant Flow|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885308|NCT00488319|OG000|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885309|NCT00488319|OG001|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885310|NCT00488319|OG002|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885311|NCT00488319|OG003|Outcome|Total|
10885312|NCT00488319|EG000|Reported Event|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885313|NCT00488319|EG001|Reported Event|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885314|NCT00488319|EG002|Reported Event|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
10885315|NCT00488345|BG000|Baseline|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
10885316|NCT00488345|BG001|Baseline|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
10885317|NCT00488345|BG002|Baseline|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
10885318|NCT00488345|BG003|Baseline|Total|Total of all reporting groups
10885319|NCT00488345|FG000|Participant Flow|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
10885320|NCT00488345|FG001|Participant Flow|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
10885321|NCT00488345|FG002|Participant Flow|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
10885322|NCT00488345|OG000|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
10885323|NCT00488345|OG001|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
10885324|NCT00488345|OG002|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
10885325|NCT00488345|OG000|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
10885326|NCT00488345|EG000|Reported Event|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
10885327|NCT00488345|EG001|Reported Event|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
10885328|NCT00488345|EG002|Reported Event|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
10885329|NCT00488475|BG000|Baseline|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
10885330|NCT00488475|FG000|Participant Flow|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
10885331|NCT00488475|OG000|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
11067060|NCT01394991|EG000|Reported Event|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
10885332|NCT00488475|EG000|Reported Event|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
10885333|NCT00488488|BG000|Baseline|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
10885334|NCT00488488|FG000|Participant Flow|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
10885335|NCT00488488|OG000|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
10885336|NCT00488488|EG000|Reported Event|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
10885337|NCT00488514|BG000|Baseline|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
10885338|NCT00488514|FG000|Participant Flow|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium. A single Combination Tablet was supplied for each migraine attack, not to exceed one tablet in 24 hours.
10885339|NCT00488514|OG000|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
10885340|NCT00488514|OG001|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
10885341|NCT00488514|OG002|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
10885342|NCT00488514|OG000|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
10885343|NCT00488514|OG000|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
10885344|NCT00488514|OG000|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet , completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
10885345|NCT00488514|OG000|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
10885346|NCT00488514|OG001|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
10885347|NCT00488514|OG002|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
10885348|NCT00488514|OG000|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|
10885349|NCT00488514|OG002|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
10885350|NCT00488514|OG000|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
10885351|NCT00488514|OG000|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet drug and had at least one post-treatment migraine assessment
10885352|NCT00488514|OG001|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
10885353|NCT00488514|OG002|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
10885354|NCT00488514|OG001|Outcome|6 Month Completer Population|Participant in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
10885355|NCT00488514|EG000|Reported Event|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
10885356|NCT00488514|EG001|Reported Event|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
10885357|NCT00488514|EG002|Reported Event|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
10887218|NCT00499369|EG000|Reported Event|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
11067061|NCT01394991|EG001|Reported Event|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
10885358|NCT00488592|BG000|Baseline|PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers|"Participants were given subcutaneous 6 injections of PR1:169-177 in Montanide adjuvant and 6 doses of WT1:126-134 in Montanide adjuvant at 2 weekly intervals. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals."
10885359|NCT00488592|FG000|Participant Flow|PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers|"Participants were given subcutaneous 6 injections of PR1:169-177 in Montanide adjuvant and 6 doses of WT1:126-134 in Montanide adjuvant at 2 weekly intervals. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals."
10885360|NCT00488592|OG000|Outcome|PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers|"Participants were given subcutaneous 6 injections of PR1:169-177 in Montanide adjuvant and 6 doses of WT1:126-134 in Montanide adjuvant at 2 weekly intervals. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals."
10885361|NCT00488592|EG000|Reported Event|PR1/WT1 Vaccine Response in Participants With Leukemias|"Participants were given subcutaneous 6 injections of PR1:169-177 in Montanide adjuvant and 6 doses of WT1:126-134 in Montanide adjuvant at 2 weekly intervals. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals."
10885362|NCT00488618|BG000|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
10885363|NCT00488618|BG001|Baseline|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
10885364|NCT00488618|BG002|Baseline|Total|Total of all reporting groups
10885365|NCT00488618|FG000|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
10885366|NCT00488618|FG001|Participant Flow|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
10885367|NCT00488618|OG000|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
10885368|NCT00488618|OG001|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
10885369|NCT00488618|EG000|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
10885370|NCT00488618|EG001|Reported Event|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
10885371|NCT00488631|BG000|Baseline|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
10885372|NCT00488631|BG001|Baseline|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
10885373|NCT00488631|BG002|Baseline|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
10885374|NCT00488631|BG003|Baseline|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
10885375|NCT00488631|BG004|Baseline|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
11067062|NCT01395017|BG000|Baseline|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
11067063|NCT01395017|BG001|Baseline|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
11067064|NCT01395017|BG002|Baseline|Total|Total of all reporting groups
11067065|NCT01395017|FG000|Participant Flow|Dasatinib + GEM|GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).
11067066|NCT01395017|FG001|Participant Flow|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
11067067|NCT01395017|OG000|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
11067068|NCT01395017|OG001|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
11067069|NCT01395017|OG000|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
11067070|NCT01395017|EG000|Reported Event|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
11067071|NCT01395017|EG001|Reported Event|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
11067072|NCT01395030|BG000|Baseline|18F-fluoromethylcholine PET/CT|"Patients undergo 18F-fluoromethylcholine PET/CT scan within 14 days of surgical resection.~Computed Tomography: Undergo FCH PET/CT~18F-fluoromethylcholine: Undergo FCH PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FCH PET/CT"
11067073|NCT01395030|FG000|Participant Flow|18F-fluoromethylcholine PET/CT|"Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.~Computed Tomography: Undergo FCH PET/CT~18F-fluoromethylcholine: Undergo FCH PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FCH PET/CT"
11067074|NCT01395030|OG000|Outcome|18F-fluoromethylcholine PET/CT|"Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.~Computed Tomography: Undergo FCH PET/CT~18F-fluoromethylcholine: Undergo FCH PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FCH PET/CT"
10849451|NCT00296296|FG000|Participant Flow|Cyclosporin|Patients receive cyclosporin (Neoral; dose-adjusted to pre-established targets) as immunosuppressive calcineurin inhibitor (CNI) and Diabetes Education / Management (therapeutic adjustment to target American Diabetes Association (ADA) criteria)
10849452|NCT00296296|FG001|Participant Flow|Tacrolimus|Patients receive tacrolimus (Prograf; dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
10849453|NCT00296296|OG000|Outcome|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
10849454|NCT00296296|OG001|Outcome|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
10849455|NCT00296296|EG000|Reported Event|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
10849456|NCT00296296|EG001|Reported Event|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
10849457|NCT00296322|BG000|Baseline|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
10849458|NCT00296322|BG001|Baseline|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
10849459|NCT00296322|BG002|Baseline|Total|Total of all reporting groups
10849460|NCT00296322|FG000|Participant Flow|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
10849461|NCT00296322|FG001|Participant Flow|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
10849462|NCT00296322|OG000|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
10849463|NCT00296322|OG001|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
10849464|NCT00296322|EG000|Reported Event|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
10849465|NCT00296322|EG001|Reported Event|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
10849466|NCT00296335|BG000|Baseline|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
10849467|NCT00296335|BG001|Baseline|Mitomycin, Doxifluridine and Cisplatin|Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
10849468|NCT00296335|BG002|Baseline|Total|Total of all reporting groups
10849469|NCT00296335|FG000|Participant Flow|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
10849470|NCT00296335|FG001|Participant Flow|Mitomycin, Doxifluridine and Cisplatin|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
10849471|NCT00296335|OG000|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
10849472|NCT00296335|OG001|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
10849473|NCT00296335|OG000|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
10849474|NCT00296335|OG001|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
10849475|NCT00296335|EG000|Reported Event|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
10849476|NCT00296335|EG001|Reported Event|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
10849477|NCT00296374|BG000|Baseline|Rosuvastatin 10mg|
10849478|NCT00296374|BG001|Baseline|Rosuvastatin 40mg|
10849479|NCT00296374|BG002|Baseline|Atorvastatin 80mg|
10849480|NCT00296374|BG003|Baseline|Total|Total of all reporting groups
10849481|NCT00296374|FG000|Participant Flow|Rosuvastatin 10mg|
10849482|NCT00296374|FG001|Participant Flow|Rosuvastatin 40mg|
10849483|NCT00296374|FG002|Participant Flow|Atorvastatin 80mg|
11147819|NCT01859741|OG000|Outcome|P1B: OMP-59R5 5mg/kg + ETO + CIS|Cohort 1: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10849484|NCT00296374|OG000|Outcome|Rosuvastatin 10mg|
10849485|NCT00296374|OG001|Outcome|Rosuvastatin 40mg|
10849486|NCT00296374|OG002|Outcome|Atorvastatin 80mg|
10849487|NCT00296374|OG000|Outcome|Rosuvastatin 10 mg|
10849488|NCT00296374|OG001|Outcome|Rosuvastatin 40 mg|
10849489|NCT00296374|OG002|Outcome|Atorvastatin 80 mg|
10849490|NCT00296374|OG000|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
10849491|NCT00296374|OG001|Outcome|Atorvastatin|Atorvastatin Treatment
10849492|NCT00296374|OG002|Outcome|All Treatment|All Treatments pooled
10849493|NCT00296374|EG000|Reported Event|Rosuvastatin 10mg|
10849494|NCT00296374|EG001|Reported Event|Rosuvastatin 40mg|
10849495|NCT00296374|EG002|Reported Event|Atorvastatin 80mg|
10849496|NCT00296400|BG000|Baseline|Rosuvastatin 10 mg|
10849497|NCT00296400|BG001|Baseline|Rosuvastatin 40 mg|
10849498|NCT00296400|BG002|Baseline|Atorvastatin 80 mg|
10849499|NCT00296400|BG003|Baseline|Total|Total of all reporting groups
10849500|NCT00296400|FG000|Participant Flow|Rosuvastatin 10 mg|
10849501|NCT00296400|FG001|Participant Flow|Rosuvastatin 40 mg|
10849502|NCT00296400|FG002|Participant Flow|Atorvastatin 80 mg|
10849503|NCT00296400|OG000|Outcome|Rosuvastatin 10 mg|
10849504|NCT00296400|OG001|Outcome|Rosuvastatin 40 mg|
10849505|NCT00296400|OG002|Outcome|Atorvastatin 80 mg|
10849506|NCT00296400|OG000|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
10849507|NCT00296400|OG001|Outcome|Atorvastatin|Atorvastatin Treatment
10849508|NCT00296400|OG002|Outcome|All Treatments|All Treatments pooled
10849509|NCT00296400|EG000|Reported Event|Rosuvastatin 10 mg|
10849510|NCT00296400|EG001|Reported Event|Rosuvastatin 40 mg|
10849511|NCT00296400|EG002|Reported Event|Atorvastatin 80 mg|
10849512|NCT00296491|BG000|Baseline|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
10849513|NCT00296491|BG001|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
10849514|NCT00296491|BG002|Baseline|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
10849515|NCT00296491|BG003|Baseline|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
10849516|NCT00296491|BG004|Baseline|Total|Total of all reporting groups
10849517|NCT00296491|FG000|Participant Flow|Flut Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Flut Prop = Fluticasone Propionate.
10849518|NCT00296491|FG001|Participant Flow|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
10849519|NCT00296491|FG002|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|
10849520|NCT00296491|FG003|Participant Flow|Montelukast (MON)|
10849521|NCT00296491|OG000|Outcome|Fluticasone Prop/Salmeterol (FSC)|
10849522|NCT00296491|OG001|Outcome|Montelukast (MON)|
10849523|NCT00296491|OG000|Outcome|Flut Prop/Salmeterol/Montelukast (FSC+MON)|
10849524|NCT00296491|OG001|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
10849525|NCT00296491|OG000|Outcome|Fluticasone Prop/Salmeterol/Montelukast (FSC+MON)|
10849526|NCT00296491|OG001|Outcome|Fluticasone Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
10849527|NCT00296491|OG000|Outcome|Flut Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
10849528|NCT00296491|OG001|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
10849529|NCT00296491|OG000|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
10849530|NCT00296491|OG000|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
10849531|NCT00296491|OG000|Outcome|Fluticasone Propionate + Salmeterol & Montelukast (FSC+MON)|
10849532|NCT00296491|EG000|Reported Event|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
10849533|NCT00296491|EG001|Reported Event|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
10849534|NCT00296491|EG002|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
10849535|NCT00296491|EG003|Reported Event|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
10849536|NCT00296504|BG000|Baseline|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
10849537|NCT00296504|BG001|Baseline|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
10849538|NCT00296504|BG002|Baseline|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
10849539|NCT00296504|BG003|Baseline|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
10849540|NCT00296504|BG004|Baseline|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
10849541|NCT00296504|BG005|Baseline|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
10849542|NCT00296504|BG006|Baseline|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
10885376|NCT00488631|BG005|Baseline|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
10885377|NCT00488631|BG006|Baseline|Total|Total of all reporting groups
10885378|NCT00488631|FG000|Participant Flow|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
10885379|NCT00488631|FG001|Participant Flow|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
10885380|NCT00488631|FG002|Participant Flow|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
10885381|NCT00488631|FG003|Participant Flow|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
10885382|NCT00488631|FG004|Participant Flow|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
10885383|NCT00488631|FG005|Participant Flow|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
10885384|NCT00488631|FG006|Participant Flow|Placebo Extension|Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
10885385|NCT00488631|FG007|Participant Flow|Golimumab 50 mg - Extension|Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
10885386|NCT00488631|FG008|Participant Flow|Golimumab 100 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
10885387|NCT00488631|FG009|Participant Flow|Golimumab 200 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
10885388|NCT00488631|OG000|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
10885389|NCT00488631|OG001|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
10885390|NCT00488631|OG002|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
11147820|NCT01859741|OG001|Outcome|P1B: OMP-59R5 7.5 mg/kg + ETO + CIS|Cohort 2: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10885391|NCT00488631|EG000|Reported Event|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
10885392|NCT00488631|EG001|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
10885393|NCT00488631|EG002|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
10885394|NCT00488631|EG003|Reported Event|GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
10885395|NCT00488631|EG004|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
10885396|NCT00488631|EG005|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
10885397|NCT00488631|EG006|Reported Event|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
10885398|NCT00488631|EG007|Reported Event|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
10885399|NCT00488631|EG008|Reported Event|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
10885400|NCT00488631|EG009|Reported Event|PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
11009935|NCT01104662|BG003|Baseline|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009936|NCT01104662|BG004|Baseline|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
11067075|NCT01395030|OG000|Outcome|18F-fluoromethylcholine PET/CT|"Patients undergo 18F-fluoromethylcholine positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection of liver tumor.~Computed Tomography: Undergo FCH PET/CT~18F-fluoromethylcholine: Undergo FCH PET/CT~Positron Emission Tomography: Undergo FCH PET/CT"
10885401|NCT00488631|EG010|Reported Event|Placebo Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
10885402|NCT00488631|EG011|Reported Event|Golimumab 50 mg Extension Phase|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
10885403|NCT00488631|EG012|Reported Event|Golimumab 100 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
10885404|NCT00488631|EG013|Reported Event|Golimumab 200 mg Extension|Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.
10885405|NCT00488631|EG014|Reported Event|Placebo - 50 mg Extension|A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.
10885406|NCT00488631|EG015|Reported Event|Placebo - Golimumab100 mg Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.
10885407|NCT00488631|EG016|Reported Event|Golimumab 50 mg - 100 mg Extension|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment
10885408|NCT00488631|EG017|Reported Event|Golimumab 100 mg - 200 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.
10885409|NCT00488644|BG000|Baseline|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
10885410|NCT00488644|FG000|Participant Flow|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
10885411|NCT00488644|OG000|Outcome|8 Weeks Post Therapy|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks.
10885412|NCT00488644|EG000|Reported Event|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
10885413|NCT00488683|BG000|Baseline|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
10885414|NCT00488683|BG001|Baseline|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
10885415|NCT00488683|BG002|Baseline|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
10885416|NCT00488683|BG003|Baseline|Total|Total of all reporting groups
10885417|NCT00488683|FG000|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
10885418|NCT00488683|FG001|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
11067076|NCT01395030|OG000|Outcome|18F-fluoromethylcholine PET/CT|"Patients undergo 18F-fluoromethylcholine PET/CT scan within 14 days of surgical resection.~Computed Tomography: Undergo FCH PET/CT~18F-fluoromethylcholine: Undergo FCH PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FCH PET/CT"
11067077|NCT01395030|EG000|Reported Event|18F-fluoromethylcholine PET/CT|"Patients undergo 18F-fluoromethylcholine PET/CT scan within 14 days of surgical resection.~Computed Tomography: Undergo FCH PET/CT~18F-fluoromethylcholine: Undergo FCH PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FCH PET/CT"
11067078|NCT01395043|BG000|Baseline|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
11067079|NCT01395043|FG000|Participant Flow|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
11067080|NCT01395043|OG000|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2,5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
11067081|NCT01395043|OG000|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters.
11067082|NCT01395043|EG000|Reported Event|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
11147821|NCT01859741|OG002|Outcome|P1B: OMP-59R5 10 mg/kg + ETO + CIS|Cohort 3: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3 and cisplatin 80 mg/m2 on Day 1).
10849543|NCT00296504|BG007|Baseline|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
10849544|NCT00296504|BG008|Baseline|Total|Total of all reporting groups
10849545|NCT00296504|FG000|Participant Flow|FPV Population (APV30001)|Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
10849546|NCT00296504|FG001|Participant Flow|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
10849547|NCT00296504|FG002|Participant Flow|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
10849548|NCT00296504|FG003|Participant Flow|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
10849549|NCT00296504|FG004|Participant Flow|FPV/RTV Once Daily (QD) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
10849550|NCT00296504|FG005|Participant Flow|FPV/RTV Twice Daily (BID) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
10849551|NCT00296504|FG006|Participant Flow|Protease Inhibitor (PI)-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
10849552|NCT00296504|FG007|Participant Flow|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
10849553|NCT00296504|FG008|Participant Flow|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
10849554|NCT00296504|OG000|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
10849555|NCT00296504|OG001|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
10849556|NCT00296504|OG002|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
10849557|NCT00296504|OG003|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
10849558|NCT00296504|OG004|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
10849559|NCT00296504|OG005|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
10849560|NCT00296504|OG006|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
10849561|NCT00296504|OG007|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
10849562|NCT00296504|OG000|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
10849563|NCT00296504|OG000|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
10849564|NCT00296504|OG001|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
10849565|NCT00296504|OG002|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
10849566|NCT00296504|OG003|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
10849567|NCT00296504|OG002|Outcome|PI-Naïve Population (Other Studies)|FFPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
10849568|NCT00296504|EG000|Reported Event|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
10849569|NCT00296504|EG001|Reported Event|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
10849570|NCT00296504|EG002|Reported Event|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
10849571|NCT00296504|EG003|Reported Event|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
10849572|NCT00296504|EG004|Reported Event|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
10849573|NCT00296504|EG005|Reported Event|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
10849574|NCT00296504|EG006|Reported Event|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
10849575|NCT00296504|EG007|Reported Event|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
11147822|NCT01859741|OG003|Outcome|P1B: OMP-59R5 12.5 mg/kg + ETO + CIS|Cohort 4: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10849576|NCT00296504|EG008|Reported Event|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
10849577|NCT00296517|BG000|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
10849578|NCT00296517|BG001|Baseline|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
10849579|NCT00296517|BG002|Baseline|Total|Total of all reporting groups
10849580|NCT00296517|FG000|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
10849581|NCT00296517|FG001|Participant Flow|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
10849582|NCT00296517|OG000|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
10849583|NCT00296517|OG001|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
10849584|NCT00296517|EG000|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
10849585|NCT00296517|EG001|Reported Event|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
10849586|NCT00296647|BG000|Baseline|Patch|
10849587|NCT00296647|BG001|Baseline|Nicotine Lozenge|
10849588|NCT00296647|BG002|Baseline|Bupropion|
10849589|NCT00296647|BG003|Baseline|Patch + Lozenge|
10849590|NCT00296647|BG004|Baseline|Buproion + Lozenge|
10849591|NCT00296647|BG005|Baseline|Total|Total of all reporting groups
10849592|NCT00296647|FG000|Participant Flow|Patch|
10849593|NCT00296647|FG001|Participant Flow|Nicotine Lozenge|
10849594|NCT00296647|FG002|Participant Flow|Bupropion|
10849595|NCT00296647|FG003|Participant Flow|Patch + Lozenge|
10849596|NCT00296647|FG004|Participant Flow|Buproion + Lozenge|
10849597|NCT00296647|OG000|Outcome|Patch|
10849598|NCT00296647|OG001|Outcome|Lozenge|
10849599|NCT00296647|OG002|Outcome|Bupropion|
10849600|NCT00296647|OG003|Outcome|Patch + Lozenge|
10849601|NCT00296647|OG004|Outcome|Buproion + Lozenge|
10849602|NCT00296647|EG000|Reported Event|Patch|
10849603|NCT00296647|EG001|Reported Event|Nicotine Lozenge|
10849604|NCT00296647|EG002|Reported Event|Bupropion|
10849605|NCT00296647|EG003|Reported Event|Patch + Lozenge|
10849606|NCT00296647|EG004|Reported Event|Buproion + Lozenge|
10849607|NCT00296725|BG000|Baseline|Fluoxetine / Imipramine|"Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated.~Imipramine: wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated."
10849608|NCT00296725|FG000|Participant Flow|Fluoxetine / Imipramine|"Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated.~Imipramine: wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated."
10849609|NCT00296725|OG000|Outcome|Fluoxetine|"fluoxetine~Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated."
10849610|NCT00296725|OG001|Outcome|Imipramine|"imipramine~Imipramine: wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated."
10849611|NCT00296725|EG000|Reported Event|Fluoxetine|"fluoxetine~Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated."
10849612|NCT00296725|EG001|Reported Event|Imipramine|"imipramine~Imipramine: wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated."
10849613|NCT00296816|BG000|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline.~Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
10849614|NCT00296816|BG001|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline.~Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
10849615|NCT00296816|BG002|Baseline|Total|Total of all reporting groups
10885419|NCT00488683|FG002|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
10885420|NCT00488683|OG000|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
10885421|NCT00488683|OG001|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
10885422|NCT00488683|OG002|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
10885423|NCT00488683|OG001|Outcome|MenACWY-CRM + Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
10885424|NCT00488683|OG002|Outcome|MenACWY-CRM + Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
10885425|NCT00488683|OG001|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
10885426|NCT00488683|OG002|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
10885427|NCT00488683|EG000|Reported Event|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
10885428|NCT00488683|EG001|Reported Event|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
10885429|NCT00488683|EG002|Reported Event|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
10885430|NCT00488774|BG000|Baseline|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
10885431|NCT00488774|BG001|Baseline|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
10885432|NCT00488774|BG002|Baseline|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
10885433|NCT00488774|BG003|Baseline|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
10885434|NCT00488774|BG004|Baseline|Total|Total of all reporting groups
10885435|NCT00488774|FG000|Participant Flow|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
10885436|NCT00488774|FG001|Participant Flow|Golimumab 1 Milligram (mg) Per Kilogram (kg)|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
10885437|NCT00488774|FG002|Participant Flow|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
10885438|NCT00488774|FG003|Participant Flow|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
10885439|NCT00488774|OG000|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
10885440|NCT00488774|OG001|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
10885441|NCT00488774|OG002|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
11147823|NCT01859741|OG004|Outcome|P1B: OMP-59R5 15 mg/kg + ETO + CIS|Cohort 5: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
11147824|NCT01859741|OG005|Outcome|P1B: OMP-59R5 15mg/kg + ETO + CARB|Cohort 6: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and carboplatin AUC of 5 mg/mL•min (Day 1).
10885442|NCT00488774|OG003|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
10885443|NCT00488774|OG002|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0
10885444|NCT00488774|EG000|Reported Event|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
10885445|NCT00488774|EG001|Reported Event|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
10885446|NCT00488774|EG002|Reported Event|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
10885447|NCT00488774|EG003|Reported Event|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
10885448|NCT00488826|BG000|Baseline|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
10885449|NCT00488826|BG001|Baseline|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
10885450|NCT00488826|BG002|Baseline|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
10885451|NCT00488826|BG003|Baseline|Total|Total of all reporting groups
10885452|NCT00488826|FG000|Participant Flow|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
10885453|NCT00488826|FG001|Participant Flow|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
10885454|NCT00488826|FG002|Participant Flow|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
10885455|NCT00488826|OG000|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
10885456|NCT00488826|OG001|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
10885457|NCT00488826|OG002|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
10885458|NCT00488826|EG000|Reported Event|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
10885459|NCT00488826|EG001|Reported Event|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
10885460|NCT00488826|EG002|Reported Event|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
10885461|NCT00488865|BG000|Baseline|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
10885462|NCT00488865|FG000|Participant Flow|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
10885463|NCT00488865|OG000|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
10885464|NCT00488865|EG000|Reported Event|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
10885465|NCT00488982|BG000|Baseline|All Patients Accrued|There were a total of 125 patients whom were accrued to the study and assigned to at least one course of docetaxel
10885466|NCT00488982|FG000|Participant Flow|Pre-Randomization|"Induction chemotherapy for 6 cycles (1 cycle = 21 days)~Docetaxel 75mg/m^2 I.V. (intravenous) on day 2~Prednisone 5 mg by mouth (p.o.), twice a day (b.i.d.) from day 1 to 21 (for 21 days)"
10885467|NCT00488982|FG001|Participant Flow|Docetaxel and Observation|Docetaxel 75mg/m^2 every 21 days
10885468|NCT00488982|FG002|Participant Flow|Docetaxel and GM-CSF|Docetaxel 75mg/m^2 every 21 days and GM-CSF 250mcg/m^2 subcutaneously days 15-28
10885469|NCT00488982|OG000|Outcome|Docetaxel and Observation|- Docetaxel 75mg/m^2 every 21 days
10885470|NCT00488982|OG001|Outcome|Docetaxel and GM-CSF|"Docetaxel 75mg/m^2 every 21 days~GM-CSF 250mcg/m2 subcutaneous (SQ) days 15-28"
10885471|NCT00488982|OG000|Outcome|Docetaxel and Observation|Docetaxel 75mg/m2 every 21 days
10885472|NCT00488982|OG001|Outcome|Docetaxel and GM-CSF|Docetaxel 75mg/m2 every 21 days GM-CSF 250mcg/m2 SQ days 15-28
10885473|NCT00488982|OG002|Outcome|Overall Survival|Includes all patients whom received any treatment starting with first course of Docetaxel at Induction
10885474|NCT00488982|OG000|Outcome|Docetaxel and Observation|- Docetaxel 75mg/m2 every 21 days
10885475|NCT00488982|OG001|Outcome|Docetaxel and GM-CSF|"Docetaxel 75mg/m2 every 21 days~GM-CSF 250mcg/m2 SQ days 15-28"
10885476|NCT00488982|OG000|Outcome|Docetaxel and Observation OFF Chemotherapy|Starting the docetaxel with observation period to date of resuming chemotherapy post initial induction
10885477|NCT00488982|OG001|Outcome|Docetaxel and GM-CSF OFF Chemotherapy|Starting the docetaxel with GM-CSF period to date of resuming chemotherapy post initial induction
10885478|NCT00488982|OG002|Outcome|Docetaxel + Observation ON Chemotherapy|Starting Docetaxel 75mg/m2 and Observation every 21 days for at least 2 days
10885479|NCT00488982|OG003|Outcome|Docetaxel and GM-CSF ON Chemotherapy|Starting Docetaxel 75mg/m2 and GM-CSF 250mcg/m2 SQ days 15-28 every 28 days with at least 2 days of Docetaxel
10885480|NCT00488982|EG000|Reported Event|All Accrued Patients|All patients were assigned to received six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects were randomized to no maintenance therapy or to maintenance GM-CSF therapy. Patients in both groups were followed until disease progression at which time GM-CSF was discontinued and another course of docetaxel and prednisone was administered again.
10885481|NCT00489086|BG000|Baseline|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
10885482|NCT00489086|FG000|Participant Flow|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
10885483|NCT00489086|OG000|Outcome|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
10885484|NCT00489086|EG000|Reported Event|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
10887219|NCT00499369|EG001|Reported Event|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887220|NCT00499369|EG002|Reported Event|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887221|NCT00499369|EG003|Reported Event|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887222|NCT00499369|EG004|Reported Event|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
10887223|NCT00499408|BG000|Baseline|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
10887224|NCT00499408|FG000|Participant Flow|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
10887225|NCT00499408|OG000|Outcome|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
10887226|NCT00499408|EG000|Reported Event|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
10887227|NCT00499447|BG000|Baseline|Radiofrequency Ablation Combined With External|
10887228|NCT00499447|FG000|Participant Flow|Radiofrequency Ablation Combined With External|
10887229|NCT00499447|OG000|Outcome|Radiofrequency Ablation Combined With External|
11147825|NCT01859741|OG000|Outcome|P2: Placebo + CIS or CARB|Placebo Arm: Active Arm: Subjects receive placebo and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg *min
10887230|NCT00499447|EG000|Reported Event|Radiofrequency Ablation Combined With External|
10887231|NCT00499460|BG000|Baseline|Garlic First, Then Placebo|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
10887232|NCT00499460|BG001|Baseline|Placebo First, Then Garlic|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
10887233|NCT00499460|BG002|Baseline|Total|Total of all reporting groups
10887234|NCT00499460|FG000|Participant Flow|Garlic First, Then Placebo|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
10887235|NCT00499460|FG001|Participant Flow|Placebo First, Then Garlic|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
10887236|NCT00499460|OG000|Outcome|Garlic|Mean and standard deviation of oxycodone oral clearance following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
10887237|NCT00499460|OG001|Outcome|Placebo|Mean and standard deviation of oxycodone oral clearance following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
10887238|NCT00499460|OG000|Outcome|Garlic|Mean and standard deviation of Cold Pressor Test Tolerance AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
10887239|NCT00499460|OG001|Outcome|Placebo|Mean and standard deviation of Cold Pressor Test Tolerance AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
10887240|NCT00499460|OG000|Outcome|Garlic|Mean and standard deviation of SSE Total Score following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
10887241|NCT00499460|OG001|Outcome|Placebo|Mean and standard deviation of SSE Total Score following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
11147826|NCT01859741|OG001|Outcome|P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB|Active Arm: Subjects receive OMP-59R5 15 mg/kg and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg *min
11147827|NCT01859741|EG000|Reported Event|P1B: OMP-59R5 5mg/kg + ETO + CIS|Cohort 1: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10887242|NCT00499460|OG000|Outcome|Garlic|Mean and standard deviation of CASE Total Score following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
10887243|NCT00499460|OG001|Outcome|Placebo|Mean and standard deviation of CASE Total Score following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
10885485|NCT00489216|BG000|Baseline|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
10885486|NCT00489216|FG000|Participant Flow|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
11147828|NCT01859741|EG001|Reported Event|P1B: OMP-59R5 7.5 mg/kg + ETO + CIS|Cohort 2: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
11147829|NCT01859741|EG002|Reported Event|P1B: OMP-59R5 10 mg/kg + ETO + CIS|Cohort 3: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3 and cisplatin 80 mg/m2 on Day 1).
10885487|NCT00489216|OG000|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
10885488|NCT00489216|EG000|Reported Event|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
10885489|NCT00489255|BG000|Baseline|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
10885490|NCT00489255|BG001|Baseline|Placebo|Placebo : Oral capsule, three times daily.
10885491|NCT00489255|BG002|Baseline|Total|Total of all reporting groups
10885492|NCT00489255|FG000|Participant Flow|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
11147830|NCT01859741|EG003|Reported Event|P1B: OMP-59R5 12.5 mg/kg + ETO + CIS|Cohort 4: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
11147831|NCT01859741|EG004|Reported Event|P1B: OMP-59R5 15 mg/kg + ETO + CIS|Cohort 5: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).
10885493|NCT00489255|FG001|Participant Flow|Tigan:Placebo|Placebo : Oral capsule, three times daily.
10885494|NCT00489255|OG000|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
10885495|NCT00489255|OG001|Outcome|Placebo|Placebo : Oral capsule, three times daily.
10885496|NCT00489255|EG000|Reported Event|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
10885497|NCT00489255|EG001|Reported Event|Placebo|Placebo : Oral capsule, three times daily.
11147832|NCT01859741|EG005|Reported Event|P1B: OMP-59R5 15mg/kg + ETO + CARB|Cohort 6: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and carboplatin AUC of 5 mg/mL•min (Day 1).
11147833|NCT01859741|EG006|Reported Event|P2: Placebo + CIS or CARB|Placebo Arm: Active Arm: Subjects receive placebo and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg *min
11147834|NCT01859741|EG007|Reported Event|P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB|Active Arm: Subjects receive OMP-59R5 15 mg/kg and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg *min
11147835|NCT01859793|BG000|Baseline|Matching Placebo 1st|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
11147836|NCT01859793|BG001|Baseline|Sitagliptin 1st|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
11147837|NCT01859793|BG002|Baseline|Total|Total of all reporting groups
10885498|NCT00489268|BG000|Baseline|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
10885499|NCT00489268|BG001|Baseline|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
10885500|NCT00489268|BG002|Baseline|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
10885501|NCT00489268|BG003|Baseline|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
10885502|NCT00489268|BG004|Baseline|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
10885503|NCT00489268|BG005|Baseline|Total|Total of all reporting groups
11225459|NCT02367885|OG000|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
11225460|NCT02367885|OG000|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
11225461|NCT02367885|OG001|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
11225462|NCT02367885|OG001|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
11225463|NCT02367885|OG002|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
11225464|NCT02367885|OG000|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
11225465|NCT02367885|EG000|Reported Event|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
11225466|NCT02367885|EG001|Reported Event|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
11225467|NCT02367885|EG002|Reported Event|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
11225468|NCT02367911|BG000|Baseline|Active Arm|"122-0551 Foam, topically applied twice daily for two weeks~122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis"
11225469|NCT02367911|BG001|Baseline|Vehicle Arm|"Vehicle Foam, topically applied twice daily for two weeks~Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis"
11225470|NCT02367911|BG002|Baseline|Total|Total of all reporting groups
11225471|NCT02367911|FG000|Participant Flow|Active Arm|"122-0551 Foam, topically applied twice daily for two weeks~122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis"
11225472|NCT02367911|FG001|Participant Flow|Vehicle Arm|"Vehicle Foam, topically applied twice daily for two weeks~Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis"
11225473|NCT02367911|OG000|Outcome|Active Arm|"122-0551 Foam, topically applied twice daily for two weeks~122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis"
11225474|NCT02367911|OG001|Outcome|Vehicle Arm|"Vehicle Foam, topically applied twice daily for two weeks~Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis"
11225475|NCT02367911|EG000|Reported Event|Active Arm|"122-0551 Foam, topically applied twice daily for two weeks~122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis"
11225476|NCT02367911|EG001|Reported Event|Vehicle Arm|"Vehicle Foam, topically applied twice daily for two weeks~Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis"
11225477|NCT02368093|BG000|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast for 6 months
11225478|NCT02368093|BG001|Baseline|Placebo|Placebo pills with the same appearance as Detosiv tablets once daily for 6 months.
11225479|NCT02368093|BG002|Baseline|Total|Total of all reporting groups
11225480|NCT02368093|FG000|Participant Flow|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
11225481|NCT02368093|FG001|Participant Flow|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
10887244|NCT00499460|OG000|Outcome|Garlic|Mean and standard deviation of oral midazolam AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
10887245|NCT00499460|OG001|Outcome|Placebo|Mean and standard deviation of oral midazolam AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
11225482|NCT02368093|OG000|Outcome|Dextromethorphan Hydrobromide|"Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast]~Dextromethorphan hydrobromide: 120mg per day with once daily dose taken after breakfast for 6 months"
11225483|NCT02368093|OG001|Outcome|Placebo|placebo pills with the same appearance as Detosiv tablets.
10849616|NCT00296816|FG000|Participant Flow|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
10849617|NCT00296816|OG000|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
10849618|NCT00296816|EG000|Reported Event|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
10849619|NCT00297037|BG000|Baseline|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
10849620|NCT00297037|BG001|Baseline|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
10849621|NCT00297037|BG002|Baseline|Total|Total of all reporting groups
10849622|NCT00297037|FG000|Participant Flow|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
10849623|NCT00297037|FG001|Participant Flow|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
10849624|NCT00297037|OG000|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
10849625|NCT00297037|OG001|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
10849626|NCT00297037|OG000|Outcome|Pimecrolimus Cream|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
10849627|NCT00297037|OG001|Outcome|Vehicle|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
10849628|NCT00297037|EG000|Reported Event|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
10849629|NCT00297037|EG001|Reported Event|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
10849630|NCT00297102|BG000|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
10849631|NCT00297102|BG001|Baseline|Placebo|once daily
10849632|NCT00297102|BG002|Baseline|Total|Total of all reporting groups
10849633|NCT00297102|FG000|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
10849634|NCT00297102|FG001|Participant Flow|Placebo|once daily
10849635|NCT00297102|OG000|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
10849636|NCT00297102|OG001|Outcome|Placebo|once daily
10849637|NCT00297102|EG000|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
10849638|NCT00297102|EG001|Reported Event|Placebo|once daily
10849639|NCT00297115|BG000|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
10849640|NCT00297115|BG001|Baseline|Placebo|once daily
10849641|NCT00297115|BG002|Baseline|Total|Total of all reporting groups
10849642|NCT00297115|FG000|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
10849643|NCT00297115|FG001|Participant Flow|Placebo|once daily
10849644|NCT00297115|OG000|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
10849645|NCT00297115|OG001|Outcome|Placebo|once daily
10849646|NCT00297115|EG000|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
10849647|NCT00297115|EG001|Reported Event|Placebo|once daily
10849648|NCT00297167|BG000|Baseline|Entire Study Population|Includes participants who received EUR-1008 (APT-1008) in open-label dose titration and stabilization phase; and EUR-1008 (APT-1008) first and placebo first after randomization to study treatment.
10849789|NCT00298272|BG000|Baseline|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
10885504|NCT00489268|FG000|Participant Flow|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic Intestinal Metaplasia (IM), Low-Grade Dysplasia (LGD) and High-Grade Dysplasia (HGD). The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
10885505|NCT00489268|FG001|Participant Flow|Phase I: 8 J/cm^2|In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
10885506|NCT00489268|FG002|Participant Flow|Phase I: 10 J/cm^2|In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
10885507|NCT00489268|FG003|Participant Flow|Phase I: 12 J/cm^2|In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
10885508|NCT00489268|FG004|Participant Flow|Phase II|In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
10885509|NCT00489268|OG000|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
10885510|NCT00489268|OG001|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
10885511|NCT00489268|OG002|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
10885512|NCT00489268|OG003|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
10885513|NCT00489268|OG004|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
11147838|NCT01859793|FG000|Participant Flow|Placebo 1st Then Sitagliptin|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally for 8 weeks followed by 8 weeks of 100 mg sitaglipin/day separated by a 4 week washout period"
10887246|NCT00499460|OG000|Outcome|Garlic|Mean and standard deviation of oral digoxin AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
10887247|NCT00499460|OG001|Outcome|Placebo|Mean and standard deviation of oral digoxin AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
11147839|NCT01859793|FG001|Participant Flow|Sitagliptin First Then Placebo|sitagliptin: 100 mg pill, administered once/day orally for 8 weeks followed by matching placebo for 8 weeks following a 4 week washout period.
10885514|NCT00489268|EG000|Reported Event|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
10885515|NCT00489268|EG001|Reported Event|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
10885516|NCT00489268|EG002|Reported Event|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
10885517|NCT00489268|EG003|Reported Event|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
10885518|NCT00489268|EG004|Reported Event|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
10885519|NCT00489281|BG000|Baseline|Transplant - 200 cGy|Conditioning regimen with anti-thymocyte globulin, fludarabine, cyclophosphamide, and total body irradiation - 200. Seizure prophylaxis with levetiracetam. Allogeneic bone marrow transplant infusion on Day 0. Graft-vs-host-disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and sirolimus.
10885520|NCT00489281|BG001|Baseline|Transplant - 400 cGy|Conditioning regimen with anti-thymocyte globulin, fludarabine, cyclophosphamide, and total body irradiation - 400. Seizure prophylaxis with levetiracetam. Allogeneic bone marrow transplant infusion on Day 0. Graft-vs-host-disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and sirolimus.
10885521|NCT00489281|BG002|Baseline|Total|Total of all reporting groups
10885522|NCT00489281|FG000|Participant Flow|Transplant - 200 cGy|Conditioning regimen with anti-thymocyte globulin, fludarabine, cyclophosphamide, and total body irradiation - 200. Seizure prophylaxis with levetiracetam. Allogeneic bone marrow transplant infusion on Day 0. Graft-vs-host-disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and sirolimus.
10885523|NCT00489281|FG001|Participant Flow|Transplant - 400 cGy|Conditioning regimen with anti-thymocyte globulin, fludarabine, cyclophosphamide, and total body irradiation - 400. Seizure prophylaxis with levetiracetam. Allogeneic bone marrow transplant infusion on Day 0. Graft-vs-host-disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and sirolimus.
10885524|NCT00489281|OG000|Outcome|Transplant - 200 cGy|Conditioning regimen with anti-thymocyte globulin, fludarabine, cyclophosphamide, and total body irradiation - 200. Seizure prophylaxis with levetiracetam. Allogeneic bone marrow transplant infusion on Day 0. Graft-vs-host-disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and sirolimus.
10887248|NCT00499460|EG000|Reported Event|Garlic|Data for all subjects during their active garlic treatment period in both arms were pooled.
10887249|NCT00499460|EG001|Reported Event|Placebo|Data for all subjects during their placebo treatment period in both arms were pooled.
11147840|NCT01859793|OG000|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
11147841|NCT01859793|OG001|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
11147842|NCT01859793|EG000|Reported Event|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
11147843|NCT01859793|EG001|Reported Event|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
11225484|NCT02368093|EG000|Reported Event|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
11225485|NCT02368093|EG001|Reported Event|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
10849685|NCT00297479|BG000|Baseline|Usual Care Group (UC)|6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
10849686|NCT00297479|BG001|Baseline|Cognitive Behavioral Treatment (CBT)|6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline
11225486|NCT02368210|BG000|Baseline|122-0551 Foam|"122-0511 Foam, topically applied twice daily~122-0551 Foam: Topical Foam"
11225487|NCT02368210|BG001|Baseline|Vehicle Foam|"Vehicle Foam, topically applied twice daily~Vehicle Foam: Topical Foam"
11225488|NCT02368210|BG002|Baseline|Total|Total of all reporting groups
11225489|NCT02368210|FG000|Participant Flow|122-0551 Foam|"122-0511 Foam, topically applied twice daily~122-0551 Foam: Topical Foam"
11225490|NCT02368210|FG001|Participant Flow|Vehicle Foam|"Vehicle Foam, topically applied twice daily~Vehicle Foam: Topical Foam"
11225491|NCT02368210|OG000|Outcome|122-0551 Foam|"122-0511 Foam, topically applied twice daily~122-0551 Foam: Topical Foam"
11225492|NCT02368210|OG001|Outcome|Vehicle Foam|"Vehicle Foam, topically applied twice daily~Vehicle Foam: Topical Foam"
10885525|NCT00489281|OG001|Outcome|Transplant - 400 cGy|Conditioning regimen with anti-thymocyte globulin, fludarabine, cyclophosphamide, and total body irradiation - 400. Seizure prophylaxis with levetiracetam. Allogeneic bone marrow transplant infusion on Day 0. Graft-vs-host-disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and sirolimus.
10885526|NCT00489281|EG000|Reported Event|Transplant - 200 cGy|Conditioning regimen with anti-thymocyte globulin, fludarabine, cyclophosphamide, and total body irradiation - 200. Seizure prophylaxis with levetiracetam. Allogeneic bone marrow transplant infusion on Day 0. Graft-vs-host-disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and sirolimus.
10885527|NCT00489281|EG001|Reported Event|Transplant - 400 cGy|Conditioning regimen with anti-thymocyte globulin, fludarabine, cyclophosphamide, and total body irradiation - 400. Seizure prophylaxis with levetiracetam. Allogeneic bone marrow transplant infusion on Day 0. Graft-vs-host-disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and sirolimus.
10885528|NCT00489359|BG000|Baseline|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
10885529|NCT00489359|BG001|Baseline|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
10885530|NCT00489359|BG002|Baseline|Total|Total of all reporting groups
10885531|NCT00489359|FG000|Participant Flow|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
10885532|NCT00489359|FG001|Participant Flow|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
10885533|NCT00489359|OG000|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
10885534|NCT00489359|OG000|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
10885535|NCT00489359|EG000|Reported Event|Pemetrexed 500 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
10885536|NCT00489359|EG001|Reported Event|Pemetrexed 600 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
10885537|NCT00489359|EG002|Reported Event|Pemetrexed 600 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
10885538|NCT00489359|EG003|Reported Event|Pemetrexed 700 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (700 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
10885539|NCT00489359|EG004|Reported Event|Pemetrexed 800 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (800 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
10885540|NCT00489359|EG005|Reported Event|Pemetrexed 900 + Carboplatin AUC 6 (Phase 1)|"Pemetrexed (900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
10885541|NCT00489359|EG006|Reported Event|Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)|"Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
10887250|NCT00499473|BG000|Baseline|Stratum I: Patients Not on EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
11225493|NCT02368210|EG000|Reported Event|122-0551 Foam|"122-0511 Foam, topically applied twice daily~122-0551 Foam: Topical Foam"
11147844|NCT01859923|BG000|Baseline|Group 1: 12 to 17 Years of Age|Participants 12 to 17 years old (inclusive) received adult formulation of delamanid 100 mg (2x50 mg tablets), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
10849687|NCT00297479|BG002|Baseline|Mindfulness-Based Treatment Group (MBAT)|6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
11147845|NCT01859923|BG001|Baseline|Group 2: 6 to 11 Years of Age|Participants 6 to 11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
10849688|NCT00297479|BG003|Baseline|Total|Total of all reporting groups
10849689|NCT00297479|FG000|Participant Flow|Usual Care Group|Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
11147846|NCT01859923|BG002|Baseline|Group 3: 3 to 5 Years of Age|Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
10885542|NCT00489411|BG000|Baseline|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
10885543|NCT00489411|BG001|Baseline|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
10885544|NCT00489411|BG002|Baseline|Total|Total of all reporting groups
10885545|NCT00489411|FG000|Participant Flow|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
10885546|NCT00489411|FG001|Participant Flow|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
10885547|NCT00489411|OG000|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
10885548|NCT00489411|OG001|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
10885549|NCT00489411|EG000|Reported Event|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
10885550|NCT00489411|EG001|Reported Event|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
10885551|NCT00489424|BG000|Baseline|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885552|NCT00489424|BG001|Baseline|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885553|NCT00489424|BG002|Baseline|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885554|NCT00489424|BG003|Baseline|Total|Total of all reporting groups
11150162|NCT01876082|FG000|Participant Flow|PAZOPANIB|"Pazopanib~800 mg per day~oral administration~at least 1 hour before or 2 hours after a meal,~until disease progression or for 12 months maximum~PAZOPANIB treatment: Pazopanib~800 mg per day~oral administration~at least 1 hour before or 2 hours after a meal,~until disease progression or for 12 months maximum"
10885555|NCT00489424|FG000|Participant Flow|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885556|NCT00489424|FG001|Participant Flow|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885557|NCT00489424|FG002|Participant Flow|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885558|NCT00489424|OG000|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885559|NCT00489424|OG001|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885560|NCT00489424|OG002|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885561|NCT00489424|EG000|Reported Event|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885562|NCT00489424|EG001|Reported Event|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
10885563|NCT00489424|EG002|Reported Event|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
11225494|NCT02368210|EG001|Reported Event|Vehicle Foam|"Vehicle Foam, topically applied twice daily~Vehicle Foam: Topical Foam"
10885564|NCT00489476|BG000|Baseline|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
10885565|NCT00489476|BG001|Baseline|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
10885566|NCT00489476|BG002|Baseline|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
10885567|NCT00489476|BG003|Baseline|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
10885568|NCT00489476|BG004|Baseline|Total|Total of all reporting groups
10885569|NCT00489476|FG000|Participant Flow|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
10885570|NCT00489476|FG001|Participant Flow|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
10885571|NCT00489476|FG002|Participant Flow|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
10885572|NCT00489476|FG003|Participant Flow|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
10885573|NCT00489476|OG000|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
10885574|NCT00489476|OG001|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
10885575|NCT00489476|OG002|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
10885576|NCT00489476|OG003|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
10885577|NCT00489476|EG000|Reported Event|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
10885578|NCT00489476|EG001|Reported Event|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
10885579|NCT00489476|EG002|Reported Event|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
10885580|NCT00489476|EG003|Reported Event|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
10885581|NCT00489489|BG000|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
10885582|NCT00489489|BG001|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
10885583|NCT00489489|BG002|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
10885584|NCT00489489|BG003|Baseline|Total|Total of all reporting groups
10885585|NCT00489489|FG000|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
10885586|NCT00489489|FG001|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
10885587|NCT00489489|FG002|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
11147847|NCT01859923|BG003|Baseline|Group 4: Birth to 2 Years of Age|"Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:~Participants >10 kilograms (kg) received DPF 10 mg BID plus OBR~Participants >8 kg and ≤10 kg received DPF 5 mg BID plus OBR~Participants ≥5.5 kg and ≤8 kg received DPF 5 mg once per day (QD) plus OBR~Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]."
11147848|NCT01859923|BG004|Baseline|Total|Total of all reporting groups
11147849|NCT01859923|FG000|Participant Flow|Group 1: 12 to 17 Years of Age|Participants 12 to 17 years old (inclusive) received adult formulation of delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) plus optimized background regimen (OBR) up to Day 182. Participants continued to receive OBR up to Day 365.
11147850|NCT01859923|FG001|Participant Flow|Group 2: 6 to 11 Years of Age|Participants 6 to 11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147851|NCT01859923|FG002|Participant Flow|Group 3: 3 to 5 Years of Age|Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147852|NCT01859923|FG003|Participant Flow|Group 4: Birth to 2 Years of Age|"Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:~Participants >10 kilograms (kg) received DPF 10 mg BID plus OBR~Participants >8 kg and ≤10 kg received DPF 5 mg BID plus OBR~Participants ≥5.5 kg and ≤8 kg received DPF 5 mg once per day (QD) plus OBR~Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]."
11147853|NCT01859923|OG000|Outcome|Group 1: 12 to 17 Years of Age|Participants 12 to 17 years old (inclusive) received adult formulation of delamanid 100 mg (2x50 mg tablets), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147854|NCT01859923|OG001|Outcome|Group 2: 6 to 11 Years of Age|Participants 6 to 11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147855|NCT01859923|OG002|Outcome|Group 3: 3 to 5 Years of Age|Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147856|NCT01859923|OG003|Outcome|Group 4: Birth to 2 Years of Age|"Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:~Participants >10 kilograms (kg) received DPF 10 mg BID plus OBR~Participants >8 kg and ≤10 kg received DPF 5 mg BID plus OBR~Participants ≥5.5 kg and ≤8 kg received DPF 5 mg once per day (QD) plus OBR~Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]."
11147857|NCT01859923|OG000|Outcome|Delamanid|Participants received delamanid 25, 50 or 100 mg based on age and weight plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147858|NCT01859923|OG000|Outcome|Group 3: 3 to 5 Years of Age|Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147859|NCT01859923|OG001|Outcome|Group 4: Birth to 2 Years of Age|"Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:~Participants >10 kilograms (kg) received DPF 10 mg BID plus OBR~Participants >8 kg and ≤10 kg received DPF 5 mg BID plus OBR~Participants ≥5.5 kg and ≤8 kg received DPF 5 mg once per day (QD) plus OBR~Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]."
11147860|NCT01859923|EG000|Reported Event|Group 1: 12 to 17 Years of Age|Participants 12-17 years old (inclusive) received adult formulation of delamanid 100 mg (2x50 mg tablets), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147861|NCT01859923|EG001|Reported Event|Group 2: 6 to 11 Years of Age|Participants 6-11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147862|NCT01859923|EG002|Reported Event|Group 3: 3 to 5 Years of Age|Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365.
11147863|NCT01859923|EG003|Reported Event|Group 4: Birth to 2 Years of Age|"Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:~Participants >10 kilograms (kg) received DPF 10 mg BID plus OBR~Participants >8 kg and ≤10 kg received DPF 5 mg BID plus OBR~Participants ≥5.5 kg and ≤8 kg received DPF 5 mg once per day (QD) plus OBR~Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]."
10885588|NCT00489489|OG000|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
11147864|NCT01859949|BG000|Baseline|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
11147865|NCT01859949|BG001|Baseline|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
11147866|NCT01859949|BG002|Baseline|Total|Total of all reporting groups
11147867|NCT01859949|FG000|Participant Flow|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
11147868|NCT01859949|FG001|Participant Flow|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
11147869|NCT01859949|OG000|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
11147870|NCT01859949|OG001|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
11147871|NCT01859949|EG000|Reported Event|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
11147872|NCT01859949|EG001|Reported Event|Dose-Remainig Group|Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study
11147873|NCT01859988|BG000|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
11147874|NCT01859988|BG001|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
11147875|NCT01859988|BG002|Baseline|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
11147876|NCT01859988|BG003|Baseline|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
11147877|NCT01859988|BG004|Baseline|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
11147878|NCT01859988|BG005|Baseline|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11147879|NCT01859988|BG006|Baseline|Total|Total of all reporting groups
11147880|NCT01859988|FG000|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection every week (qw) from Week 1 to Week 15.
11147881|NCT01859988|FG001|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.
11147882|NCT01859988|FG002|Participant Flow|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
11147883|NCT01859988|FG003|Participant Flow|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
11147884|NCT01859988|FG004|Participant Flow|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
11147885|NCT01859988|FG005|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11147886|NCT01859988|OG000|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
11147887|NCT01859988|OG001|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
11147888|NCT01859988|OG002|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
11147889|NCT01859988|OG003|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
11147890|NCT01859988|OG004|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
11147891|NCT01859988|OG005|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11147892|NCT01859988|EG000|Reported Event|Dupilumab 300 mg qw|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
11147893|NCT01859988|EG001|Reported Event|Dupilumab 300 mg q2w|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
11147894|NCT01859988|EG002|Reported Event|Dupilumab 200 mg q2w|Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
11147895|NCT01859988|EG003|Reported Event|Dupilumab 300 mg q4w|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
11147896|NCT01859988|EG004|Reported Event|Dupilumab 100 mg q4w|Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
11147897|NCT01859988|EG005|Reported Event|Placebo|Participants who received 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.
11147898|NCT01860079|BG000|Baseline|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
11147899|NCT01860079|BG001|Baseline|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
11147900|NCT01860079|BG002|Baseline|Total|Total of all reporting groups
11147901|NCT01860079|FG000|Participant Flow|Early Discharge Group|In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
11147902|NCT01860079|FG001|Participant Flow|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure.
11147903|NCT01860079|OG000|Outcome|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
11147904|NCT01860079|OG001|Outcome|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
10885589|NCT00489489|OG001|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
10885590|NCT00489489|OG002|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
10885591|NCT00489489|OG000|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
10885592|NCT00489489|OG001|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
10885593|NCT00489489|EG000|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with IFN-β for 24 weeks
10885594|NCT00489489|EG001|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
11225495|NCT02368314|BG000|Baseline|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
10885595|NCT00489489|EG002|Reported Event|Teriflunomide 14 mg + + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
10885596|NCT00489541|BG000|Baseline|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
10885597|NCT00489541|BG001|Baseline|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
10885598|NCT00489541|BG002|Baseline|Total|Total of all reporting groups
10885599|NCT00489541|FG000|Participant Flow|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
10885600|NCT00489541|FG001|Participant Flow|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
10885601|NCT00489541|OG000|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
10885602|NCT00489541|OG001|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
10885603|NCT00489541|EG000|Reported Event|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
10885604|NCT00489541|EG001|Reported Event|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
10885605|NCT00489554|BG000|Baseline|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
10885606|NCT00489554|FG000|Participant Flow|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
10885607|NCT00489554|OG000|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
10885608|NCT00489554|EG000|Reported Event|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
10885609|NCT00489736|BG000|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
10885610|NCT00489736|BG001|Baseline|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
10885611|NCT00489736|BG002|Baseline|Total|Total of all reporting groups
10885612|NCT00489736|FG000|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
10885613|NCT00489736|FG001|Participant Flow|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
10885614|NCT00489736|OG000|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
10885615|NCT00489736|OG001|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
10885616|NCT00489736|EG000|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
10885617|NCT00489736|EG001|Reported Event|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
10885618|NCT00489853|BG000|Baseline|Entire Study Population|Cross over study with 3 Arms. (1)Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily. (2)Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily. (3) Placebo, 1 inhalation twice daily
10885619|NCT00489853|FG000|Participant Flow|Symbicort Then Formoterol Then Placebo|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
10885620|NCT00489853|FG001|Participant Flow|Formoterol Then Symbicort Then Placebo|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
10885621|NCT00489853|FG002|Participant Flow|Placebo Then Formoterol Then Symbicort|Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
10885622|NCT00489853|OG000|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
10885623|NCT00489853|OG001|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
10885624|NCT00489853|OG002|Outcome|Placebo|Placebo, 1 inhalation twice daily
10885625|NCT00489853|EG000|Reported Event|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
10885626|NCT00489853|EG001|Reported Event|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
10885627|NCT00489853|EG002|Reported Event|Placebo|Placebo, 1 inhalation twice daily
10885628|NCT00489866|BG000|Baseline|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
10885629|NCT00489866|BG001|Baseline|Placebo|Identical to Aripiprazole
10885630|NCT00489866|BG002|Baseline|Total|Total of all reporting groups
10885631|NCT00489866|FG000|Participant Flow|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
10885632|NCT00489866|FG001|Participant Flow|Placebo|Identical to Aripiprazole
10885633|NCT00489866|OG000|Outcome|PTSD Symptoms Aripiprazole Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
10885634|NCT00489866|OG001|Outcome|PTSD Symptoms Placebo Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
10885635|NCT00489866|OG000|Outcome|Cognitive Symptoms Aripiprazole Treated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
10885636|NCT00489866|OG001|Outcome|Cognitive Symptoms PlaceboTreated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
10885637|NCT00489866|OG000|Outcome|Psychotic Symptoms Aripiprazole Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
10885638|NCT00489866|OG001|Outcome|Psychotic Symptoms Placebo Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
10885639|NCT00489866|OG000|Outcome|Resilience Symptoms Aripiprazole Treated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
10885640|NCT00489866|OG001|Outcome|Resilience Symptoms PlaceboTreated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
10885641|NCT00489866|OG000|Outcome|Depression Symptoms Aripiprazole Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
10885642|NCT00489866|OG001|Outcome|Depression Symptoms Placebo Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
10885643|NCT00489866|EG000|Reported Event|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
10885644|NCT00489866|EG001|Reported Event|Placebo|Identical to Aripiprazole
10885645|NCT00489918|BG000|Baseline|Macroflux® Placebo|"Macroflux® placebo patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885646|NCT00489918|BG001|Baseline|Macroflux® 20 mcg|"Macroflux® 20 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885647|NCT00489918|BG002|Baseline|Macroflux® 30 mcg|"Macroflux® 30 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885648|NCT00489918|BG003|Baseline|Macroflux® 40 mcg|"Macroflux® 40 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885649|NCT00489918|BG004|Baseline|FORTEO®|"FORTEO® 20 mcg injection~teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh"
10885650|NCT00489918|BG005|Baseline|Total|Total of all reporting groups
11150163|NCT01876082|FG001|Participant Flow|Vinblastine and Methotrexate|"vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.~Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months."
10885651|NCT00489918|FG000|Participant Flow|Macroflux® Placebo|"Macroflux® placebo patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885652|NCT00489918|FG001|Participant Flow|Macroflux® 20 mcg|"Macroflux® 20 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885653|NCT00489918|FG002|Participant Flow|Macroflux® 30 mcg|"Macroflux® 30 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885654|NCT00489918|FG003|Participant Flow|Macroflux® 40 mcg|"Macroflux® 40 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885655|NCT00489918|FG004|Participant Flow|FORTEO®|"FORTEO® 20 mcg injection~teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh"
10885656|NCT00489918|OG000|Outcome|Macroflux® Placebo|"Macroflux® placebo patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885657|NCT00489918|OG001|Outcome|Macroflux® 20 mcg|"Macroflux® 20 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885658|NCT00489918|OG002|Outcome|Macroflux® 30 mcg|"Macroflux® 30 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885659|NCT00489918|OG003|Outcome|Macroflux® 40 mcg|"Macroflux® 40 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885660|NCT00489918|OG004|Outcome|FORTEO®|"FORTEO® 20 mcg injection~teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh"
10885661|NCT00489918|EG000|Reported Event|Macroflux® Placebo|"Macroflux® placebo patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885662|NCT00489918|EG001|Reported Event|Macroflux® 20 mcg|"Macroflux® 20 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885663|NCT00489918|EG002|Reported Event|Macroflux® 30 mcg|"Macroflux® 30 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885664|NCT00489918|EG003|Reported Event|Macroflux® 40 mcg|"Macroflux® 40 mcg patch~teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily"
10885665|NCT00489918|EG004|Reported Event|FORTEO®|"FORTEO® 20 mcg injection~teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh"
10885666|NCT00489970|BG000|Baseline|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).
11147905|NCT01860079|EG000|Reported Event|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~During 2 year study period, 900 PPCI patients arrived at the three different study centers. 769 patients were randomized in to two groups. There were 384 patients in the early discharge arm. Four patients were excluded due to social repatriation reasons. Furthermore, a total of 10 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 370 patients in the early discharge group."
10885667|NCT00489970|BG001|Baseline|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
10885668|NCT00489970|BG002|Baseline|Control Group|Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
10885669|NCT00489970|BG003|Baseline|Total|Total of all reporting groups
10885670|NCT00489970|FG000|Participant Flow|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).
10885671|NCT00489970|FG001|Participant Flow|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
10885672|NCT00489970|FG002|Participant Flow|Control Group|Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
10885673|NCT00489970|OG000|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).
10885674|NCT00489970|OG001|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
10885675|NCT00489970|OG002|Outcome|Control Group|Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
10885676|NCT00489970|OG000|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the nondominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap] (GSK776423).
10885677|NCT00489970|OG001|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423) divided by Infanrix Group in APV-039 who included subjects who received 3 consecutive doses of Infanrix.
10885678|NCT00489970|OG001|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
10885679|NCT00489970|EG000|Reported Event|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).
10885680|NCT00489970|EG001|Reported Event|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
10885681|NCT00489970|EG002|Reported Event|Control Group|Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
10885682|NCT00490009|BG000|Baseline|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
10885683|NCT00490009|FG000|Participant Flow|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
10885684|NCT00490009|OG000|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA-approved regimen for other indications.
10885685|NCT00490009|OG000|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
10885686|NCT00490009|EG000|Reported Event|Bexxar + Tylenol + Benadryl + SSKI|Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. Bexxar is patient specific: 75 cGy whole body patients with platelet count of 150,000/mm³ and 65 cGy for patients with platelet count less than 150,000/mm³, IV
10885687|NCT00490022|BG000|Baseline|Placebo DHT Gel|Placebo gel for one month
10885688|NCT00490022|BG001|Baseline|DHT Gel|DHT gel (70 mg/day) for one month
10885689|NCT00490022|BG002|Baseline|Total|Total of all reporting groups
10885690|NCT00490022|FG000|Participant Flow|Placebo DHT Gel|Placebo gel for one month
10885691|NCT00490022|FG001|Participant Flow|DHT Gel|DHT gel (70 mg/day) for one month
10885692|NCT00490022|OG000|Outcome|Placebo DHT Gel|Placebo gel for one month
10885693|NCT00490022|OG001|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
10885694|NCT00490022|EG000|Reported Event|Placebo DHT Gel|Placebo gel for one month
10885695|NCT00490022|EG001|Reported Event|DHT Gel|DHT gel (70 mg/day) for one month
10885696|NCT00490035|BG000|Baseline|Placebo|Matching Placebo tablets administered twice a day
10885697|NCT00490035|BG001|Baseline|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
11150164|NCT01876082|OG000|Outcome|PAZOPANIB|"Pazopanib~800 mg per day~oral administration~at least 1 hour before or 2 hours after a meal,~until disease progression or for 12 months maximum~PAZOPANIB treatment: Pazopanib~800 mg per day~oral administration~at least 1 hour before or 2 hours after a meal,~until disease progression or for 12 months maximum"
10885698|NCT00490035|BG002|Baseline|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10885699|NCT00490035|BG003|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
10885700|NCT00490035|BG004|Baseline|Total Title|
10885701|NCT00490035|FG000|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
10885702|NCT00490035|FG001|Participant Flow|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10885703|NCT00490035|FG002|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10885704|NCT00490035|FG003|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
10885705|NCT00490035|OG000|Outcome|Placebo|Matching Placebo tablets administered twice a day
10885706|NCT00490035|OG001|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10885707|NCT00490035|OG002|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10885708|NCT00490035|OG003|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
10885709|NCT00490035|EG000|Reported Event|Placebo|Matching Placebo tablets administered twice a day
10885710|NCT00490035|EG001|Reported Event|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10885711|NCT00490035|EG002|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10885712|NCT00490035|EG003|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
10885713|NCT00490061|BG000|Baseline|Radiotherapy (Radiation) and Lapatinib|"1500mg/d once daily oral lapatinib administration plus Intensity Modulated Radio Therapy (IMRT) delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.~Lapatinib: 1500 mg po daily orally~Radiotherapy (radiation): Standard of Care~G.E. Healthcare 1.5T MR, systems revision 12.0 M5: Standard of Care, used to deliver IMRT~PET/CT: A subset of patients received imaging before and after treatment."
10885714|NCT00490061|FG000|Participant Flow|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
10885715|NCT00490061|OG000|Outcome|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
10885716|NCT00490061|EG000|Reported Event|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
10885717|NCT00490100|BG000|Baseline|Treatment|
10885718|NCT00490100|FG000|Participant Flow|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
10885719|NCT00490100|OG000|Outcome|Treatment|"XSCID patients with growth failre treated with Increlex, recombinant human IGF-1.~Increlex"
10885720|NCT00490100|OG000|Outcome|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
10885721|NCT00490100|EG000|Reported Event|Treatment|
10885722|NCT00490139|BG000|Baseline|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10849690|NCT00297479|FG001|Participant Flow|Cognitive Behavioral Treatment (CBT)|Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
10849691|NCT00297479|FG002|Participant Flow|Mindfulness-Based Treatment Group (MBAT)|MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.
10849692|NCT00297479|OG000|Outcome|Usual Care Group (UC)|6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
10849693|NCT00297479|OG001|Outcome|Cognitive Behavioral Treatment (CBT)|6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline
10885723|NCT00490139|BG001|Baseline|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885724|NCT00490139|BG002|Baseline|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885725|NCT00490139|BG003|Baseline|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885726|NCT00490139|BG004|Baseline|Total|Total of all reporting groups
10885727|NCT00490139|FG000|Participant Flow|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885728|NCT00490139|FG001|Participant Flow|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885729|NCT00490139|FG002|Participant Flow|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885730|NCT00490139|FG003|Participant Flow|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10887251|NCT00499473|BG001|Baseline|Stratum 2: Patients on EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
10887252|NCT00499473|BG002|Baseline|Total|Total of all reporting groups
11150165|NCT01876082|OG001|Outcome|Vinblastine and Methotrexate|"vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.~Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months."
10887253|NCT00499473|FG000|Participant Flow|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
10885731|NCT00490139|OG000|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885732|NCT00490139|OG001|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885733|NCT00490139|OG002|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885734|NCT00490139|OG003|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885735|NCT00490139|OG002|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885736|NCT00490139|OG003|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885737|NCT00490139|EG000|Reported Event|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885738|NCT00490139|EG001|Reported Event|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
11225496|NCT02368314|BG001|Baseline|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
11066014|NCT01390818|BG011|Baseline|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066015|NCT01390818|BG012|Baseline|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
10849694|NCT00297479|OG002|Outcome|Mindfulness-Based Treatment Group (MBAT)|6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
10849695|NCT00297479|EG000|Reported Event|Usual Care Group|Usual Care (UC) 6 weeks of nicotine patch therapy, Self-help guide & In-person individual counseling (4 sessions over 8 weeks)
10849696|NCT00297479|EG001|Reported Event|Standard Care Group|Standard Care Group (ST) 6 weeks of nicotine patch therapy, Self-help guide & In-person group therapy/counseling (8 sessions over 8 weeks)
10849697|NCT00297479|EG002|Reported Event|Mindfulness-Based Treatment Group (MBAT)|MBAT 6 weeks of nicotine patch therapy; Self-help guide; & In-person group therapy/counseling (8 sessions over 8 weeks) using a MBAT for nicotine dependence.
10849698|NCT00297492|BG000|Baseline|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
10849699|NCT00297492|BG001|Baseline|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
10849700|NCT00297492|BG002|Baseline|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
10849701|NCT00297492|BG003|Baseline|Total|Total of all reporting groups
10849702|NCT00297492|FG000|Participant Flow|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
10849703|NCT00297492|FG001|Participant Flow|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
10849704|NCT00297492|FG002|Participant Flow|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
10849705|NCT00297492|OG000|Outcome|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date; nicotine lozenges were provided to aid reduction prior to the quit date and for use on and following the quit date.
10849706|NCT00297492|OG001|Outcome|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date.
10849707|NCT00297492|OG002|Outcome|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date.
10849708|NCT00297492|EG000|Reported Event|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
10849709|NCT00297492|EG001|Reported Event|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
10849710|NCT00297492|EG002|Reported Event|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
10849711|NCT00297596|BG000|Baseline|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
10849712|NCT00297596|FG000|Participant Flow|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
10849713|NCT00297596|OG000|Outcome|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
10849714|NCT00297596|EG000|Reported Event|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
10885739|NCT00490139|EG002|Reported Event|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885740|NCT00490139|EG003|Reported Event|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
10885741|NCT00490256|BG000|Baseline|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
10885742|NCT00490256|BG001|Baseline|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
10885743|NCT00490256|BG002|Baseline|Total|Total of all reporting groups
10885744|NCT00490256|FG000|Participant Flow|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
10885745|NCT00490256|FG001|Participant Flow|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
10885746|NCT00490256|OG000|Outcome|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
10885747|NCT00490256|OG001|Outcome|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
10885748|NCT00490256|EG000|Reported Event|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
10885749|NCT00490256|EG001|Reported Event|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
10885750|NCT00490269|BG000|Baseline|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
10885751|NCT00490269|BG001|Baseline|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
10885752|NCT00490269|BG002|Baseline|Total|Total of all reporting groups
10885753|NCT00490269|FG000|Participant Flow|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
10885754|NCT00490269|FG001|Participant Flow|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
10885755|NCT00490269|OG000|Outcome|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
10885756|NCT00490269|OG001|Outcome|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
10885757|NCT00490269|EG000|Reported Event|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
10885758|NCT00490269|EG001|Reported Event|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
10885759|NCT00490282|BG000|Baseline|Image-Guided Adaptive Radiotherapy|"Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART)~Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks~Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks"
10885760|NCT00490282|FG000|Participant Flow|Image-Guided Adaptive Radiotherapy|"Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART)~Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks~Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks"
10885761|NCT00490282|OG000|Outcome|ART1|"Intensity Modulated Radiotherapy (IMRT) + IGRT with one adaptive replan (ART1)~Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks~Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks"
10885762|NCT00490282|OG001|Outcome|ART2|"Intensity Modulated Radiotherapy (IMRT) + IGRT with two adaptive replans (ART2)~Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks~Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks"
11225497|NCT02368314|BG002|Baseline|Total|Total of all reporting groups
10885763|NCT00490282|EG000|Reported Event|Image-Guided Adaptive Radiotherapy|"Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART)~Intensity Modulated Radiation Therapy: IMRT Treatment Over 6-7 Weeks~Adaptive Radiotherapy: ART Treatment Over 6-7 Weeks"
10885764|NCT00490451|BG000|Baseline|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
10885765|NCT00490451|BG001|Baseline|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
10885766|NCT00490451|BG002|Baseline|Total|Total of all reporting groups
10885767|NCT00490451|FG000|Participant Flow|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
10885768|NCT00490451|FG001|Participant Flow|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
10885769|NCT00490451|OG000|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
10885770|NCT00490451|OG001|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
10885771|NCT00490451|EG000|Reported Event|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
10885772|NCT00490451|EG001|Reported Event|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
10885773|NCT00490477|BG000|Baseline|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
10885774|NCT00490477|BG001|Baseline|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
10885775|NCT00490477|BG002|Baseline|Total|Total of all reporting groups
10885776|NCT00490477|FG000|Participant Flow|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
10885777|NCT00490477|FG001|Participant Flow|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
10885778|NCT00490477|OG000|Outcome|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
10885779|NCT00490477|OG001|Outcome|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
10885780|NCT00490477|EG000|Reported Event|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
10885781|NCT00490477|EG001|Reported Event|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
10885782|NCT00490490|BG000|Baseline|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
10885783|NCT00490490|FG000|Participant Flow|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
10885784|NCT00490490|OG000|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
10885785|NCT00490490|EG000|Reported Event|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
10885786|NCT00490529|BG000|Baseline|CpG-MCL Vaccine|An autologous anti-tumor vaccine.
10885787|NCT00490529|FG000|Participant Flow|CpG-MCL Vaccine|An autologous anti-tumor vaccine.
11147906|NCT01860079|EG001|Reported Event|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure. During the two year study period, 900 PPCI patients arrived at the three different study centers. After the exclusion of 131 patients due to primary exclusion criteria 769 patients were randomized in to two groups. There were 385 patients in the standard discharge group. Sixteen patients were excluded due to primary exclusion criteria such as signs of heart failure (n=7, %), clinically significant arrhythmia requiring treatment (n=3, %), chest pain recurrence (n=4,%), cardiogenic shock (n=1,%). Furthermore, a total of 6 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 363 patients in the standard discharge group.
11150166|NCT01876082|EG000|Reported Event|PAZOPANIB|"Pazopanib~800 mg per day~oral administration~at least 1 hour before or 2 hours after a meal,~until disease progression or for 12 months maximum~PAZOPANIB treatment: Pazopanib~800 mg per day~oral administration~at least 1 hour before or 2 hours after a meal,~until disease progression or for 12 months maximum"
10885788|NCT00490529|OG000|Outcome|CpG-MCL Vaccine|"An autologous anti-tumor vaccine.~CpG-MCL vaccine: CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection.~PF-3512676: PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs.~Vaccine-primed T-cells: Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells.~Autologous hematopoietic stem cell transplant (HSCT): Regular medical procedure~Rituximab: 375 mg/m² by infusion~Standard induction chemotherapy: Patient-specific, regular medical care treatment as determined by treating oncologist~Cyclophosphamide: Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)"
10885789|NCT00490529|EG000|Reported Event|CpG-MCL Vaccine|An autologous anti-tumor vaccine.
10885790|NCT00490542|BG000|Baseline|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
10885791|NCT00490542|BG001|Baseline|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
10885792|NCT00490542|BG002|Baseline|Total|Total of all reporting groups
10885793|NCT00490542|FG000|Participant Flow|Double-blind Flexible-dose Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing was flexible. Dosing for all subjects was determined based on clinician judgment in an identical manner to dosing in the ziprasidone arm.
10885794|NCT00490542|FG001|Participant Flow|Double-blind Flexible-dose Ziprasidone Arm|Participants in this arm received a flexible dose of ziprasidone and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing for all subjects began at 20 mg twice a day and increased to between 80 and 160 mg/day total.
10885795|NCT00490542|OG000|Outcome|Ziprasidone Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
10885796|NCT00490542|OG001|Outcome|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
10885797|NCT00490542|EG000|Reported Event|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
10885798|NCT00490542|EG001|Reported Event|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
10885799|NCT00490555|BG000|Baseline|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
10885800|NCT00490555|BG001|Baseline|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
10885801|NCT00490555|BG002|Baseline|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
10885802|NCT00490555|BG003|Baseline|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
10885803|NCT00490555|BG004|Baseline|Total|Total of all reporting groups
10885804|NCT00490555|FG000|Participant Flow|1) Placebo|Placebo gel + Placebo pill + placebo DMPA
11147907|NCT01860170|BG000|Baseline|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
10885805|NCT00490555|FG001|Participant Flow|2) Testosterone (T) Gel|Testosterone 1% transdermal gel 10g (Testim)+ placebo pill, daily + placebo DMPA
10885806|NCT00490555|FG002|Participant Flow|3) T Gel+Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
10885807|NCT00490555|FG003|Participant Flow|4) T Gel+DMPA|Testosterone 1% transdermal gel 10g, daily + placebo Dutasteride pill, daily + DMPA 300mg injection (IM)
10885808|NCT00490555|OG000|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
10885809|NCT00490555|OG001|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
10885810|NCT00490555|OG002|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
10885811|NCT00490555|OG003|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
10885812|NCT00490555|EG000|Reported Event|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
10885813|NCT00490555|EG001|Reported Event|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
10885814|NCT00490555|EG002|Reported Event|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
10885815|NCT00490555|EG003|Reported Event|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
10885816|NCT00490568|BG000|Baseline|RSG XR (AVA102675)|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
11009937|NCT01104662|BG005|Baseline|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009938|NCT01104662|BG006|Baseline|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
11009939|NCT01104662|BG007|Baseline|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009940|NCT01104662|BG008|Baseline|Total|Total of all reporting groups
11009941|NCT01104662|FG000|Participant Flow|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
11009942|NCT01104662|FG001|Participant Flow|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin/semi-synthetic penicillin (SSP; for example, nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009943|NCT01104662|FG002|Participant Flow|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
11009944|NCT01104662|FG003|Participant Flow|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11066016|NCT01390818|BG013|Baseline|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066017|NCT01390818|BG014|Baseline|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066018|NCT01390818|BG015|Baseline|Total|Total of all reporting groups
11066019|NCT01390818|FG000|Participant Flow|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (Dose Escalation [DE] cohort).
11066020|NCT01390818|FG001|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066021|NCT01390818|FG002|Participant Flow|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11009945|NCT01104662|FG004|Participant Flow|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For complicated skin and skin structure infections (cSSSI) participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
11009946|NCT01104662|FG005|Participant Flow|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009947|NCT01104662|FG006|Participant Flow|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
11009948|NCT01104662|FG007|Participant Flow|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009949|NCT01104662|OG000|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
11009950|NCT01104662|OG001|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11147908|NCT01860170|BG001|Baseline|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11147909|NCT01860170|BG002|Baseline|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11147910|NCT01860170|BG003|Baseline|Total|Total of all reporting groups
11147911|NCT01860170|FG000|Participant Flow|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11150167|NCT01876082|EG001|Reported Event|Vinblastine and Methotrexate|"vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.~Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months."
11009951|NCT01104662|OG002|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
11009952|NCT01104662|OG003|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009953|NCT01104662|OG004|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
11009954|NCT01104662|OG005|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009955|NCT01104662|OG006|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
11009956|NCT01104662|OG007|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009957|NCT01104662|OG002|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion
11009958|NCT01104662|EG000|Reported Event|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.)
11009959|NCT01104662|EG001|Reported Event|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11150168|NCT01876212|BG000|Baseline|Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)|"Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5).~All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours).~The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle."
10885817|NCT00490568|FG000|Participant Flow|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of Acetylcholinesterase Inhibitor (AChEI) for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received oral 4 milligram (mg) once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
11009960|NCT01104662|EG002|Reported Event|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
11009961|NCT01104662|EG003|Reported Event|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009962|NCT01104662|EG004|Reported Event|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
11009963|NCT01104662|EG005|Reported Event|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009964|NCT01104662|EG006|Reported Event|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
11009965|NCT01104662|EG007|Reported Event|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11009966|NCT01104701|BG000|Baseline|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
11009967|NCT01104701|BG001|Baseline|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
11009968|NCT01104701|BG002|Baseline|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
11009969|NCT01104701|BG003|Baseline|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
11009970|NCT01104701|BG004|Baseline|Total|Total of all reporting groups
11009971|NCT01104701|FG000|Participant Flow|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
11009972|NCT01104701|FG001|Participant Flow|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
11009973|NCT01104701|FG002|Participant Flow|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
11009974|NCT01104701|FG003|Participant Flow|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
11009975|NCT01104701|OG000|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
11009976|NCT01104701|OG001|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
11147912|NCT01860170|FG001|Participant Flow|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11009977|NCT01104701|OG002|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11009978|NCT01104701|OG003|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
11009979|NCT01104701|EG000|Reported Event|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
11009980|NCT01104701|EG001|Reported Event|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
11009981|NCT01104701|EG002|Reported Event|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
11009982|NCT01104701|EG003|Reported Event|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
11009983|NCT01104766|BG000|Baseline|Placebo|Oral administration. Once per day.
11009984|NCT01104766|BG001|Baseline|Cariprazine 3.0 mg|Oral administration. Once per day.
11009985|NCT01104766|BG002|Baseline|Cariprazine 6.0mg|Oral administration. Once per day.
11009986|NCT01104766|BG003|Baseline|Aripiprazole 10.0 mg|Oral administration. Once per day.
11009987|NCT01104766|BG004|Baseline|Total|Total of all reporting groups
11009988|NCT01104766|FG000|Participant Flow|Placebo|Oral administration. Once per day.
11009989|NCT01104766|FG001|Participant Flow|Cariprazine 3.0 mg|Oral administration. Once per day.
11009990|NCT01104766|FG002|Participant Flow|Cariprazine 6.0mg|Oral administration. Once per day.
11009991|NCT01104766|FG003|Participant Flow|Aripiprazole 10.0 mg|Oral administration. Once per day.
11009992|NCT01104766|OG000|Outcome|Placebo|Oral administration. Once per day.
11009993|NCT01104766|OG001|Outcome|Cariprazine 3.0 mg|Oral administration. Once per day.
11009994|NCT01104766|OG002|Outcome|Cariprazine 6.0mg|Oral administration. Once per day.
11009995|NCT01104766|OG003|Outcome|Aripiprazole 10.0 mg|Oral administration. Once per day.
11009996|NCT01104766|EG000|Reported Event|Placebo|Oral administration. Once per day.
11009997|NCT01104766|EG001|Reported Event|Cariprazine 3.0 mg|Oral administration. Once per day.
11009998|NCT01104766|EG002|Reported Event|Cariprazine 6.0mg|Oral administration. Once per day.
11147913|NCT01860170|FG002|Participant Flow|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11009999|NCT01104766|EG003|Reported Event|Aripiprazole 10.0 mg|Oral administration. Once per day.
11010000|NCT01104779|BG000|Baseline|Placebo|Oral administration. Once per day.
11010001|NCT01104779|BG001|Baseline|Cariprazine (3-6 mg/Day)|Oral administration. Once per day.
11010002|NCT01104779|BG002|Baseline|Cariprazine (6-9 mg/Day)|Oral administration. Once per day.
11010003|NCT01104779|BG003|Baseline|Total|Total of all reporting groups
11010004|NCT01104779|FG000|Participant Flow|Placebo|Oral administration. Once per day.
11010005|NCT01104779|FG001|Participant Flow|Cariprazine (3-6 mg/Day)|Oral administration. Once per day.
11010006|NCT01104779|FG002|Participant Flow|Cariprazine (6-9 mg/Day)|Oral administration. Once per day.
11010007|NCT01104779|OG000|Outcome|Placebo|Oral administration. Once per day.
11010008|NCT01104779|OG001|Outcome|Cariprazine (3-6 mg/Day)|Oral administration. Once per day.
11010009|NCT01104779|OG002|Outcome|Cariprazine (6-9 mg/Day)|Oral administration. Once per day.
11010010|NCT01104779|EG000|Reported Event|Placebo|Oral administration. Once per day.
11010011|NCT01104779|EG001|Reported Event|Cariprazine (3-6 mg/Day)|Oral administration. Once per day.
11010012|NCT01104779|EG002|Reported Event|Cariprazine (6-9 mg/Day)|Oral administration. Once per day.
11010013|NCT01104792|BG000|Baseline|Cariprazine|Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
11010014|NCT01104792|FG000|Participant Flow|Cariprazine|Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
11010015|NCT01104792|OG000|Outcome|Cariprazine|Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
11010016|NCT01104792|EG000|Reported Event|Cariprazine|Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
11010017|NCT01104870|BG000|Baseline|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
11010018|NCT01104870|BG001|Baseline|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
11010019|NCT01104870|BG002|Baseline|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
11010020|NCT01104870|BG003|Baseline|Total|Total of all reporting groups
11010021|NCT01104870|FG000|Participant Flow|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
11010022|NCT01104870|FG001|Participant Flow|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
11010023|NCT01104870|FG002|Participant Flow|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
11010024|NCT01104870|OG000|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
11010025|NCT01104870|OG001|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
11010026|NCT01104870|OG002|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
11010027|NCT01104870|EG000|Reported Event|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
11010028|NCT01104870|EG001|Reported Event|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
11010029|NCT01104870|EG002|Reported Event|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
11010030|NCT01105065|BG000|Baseline|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
11010031|NCT01105065|FG000|Participant Flow|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
11010032|NCT01105065|OG000|Outcome|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
11010033|NCT01105065|OG000|Outcome|RVD Patients Pre-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients before their treatment with brimonidine.
11010034|NCT01105065|OG001|Outcome|RVD Patients Post-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients after their treatment with brimonidine.
11010035|NCT01105065|EG000|Reported Event|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
11010036|NCT01105091|BG000|Baseline|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
11010037|NCT01105091|BG001|Baseline|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
11010038|NCT01105091|BG002|Baseline|Total|Total of all reporting groups
11010039|NCT01105091|FG000|Participant Flow|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
11010040|NCT01105091|FG001|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
11010041|NCT01105091|OG000|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
11010042|NCT01105091|OG001|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
11010043|NCT01105091|OG000|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
11010044|NCT01105091|OG001|Outcome|Flolan (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
11010045|NCT01105091|EG000|Reported Event|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
11010046|NCT01105091|EG001|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
11150169|NCT01876212|BG001|Baseline|Vaccine + Dasatinib (Cycle 1, D1)|"Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1.~All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours).~The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle."
11150170|NCT01876212|BG002|Baseline|Total|Total of all reporting groups
11010047|NCT01105117|BG000|Baseline|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
11010048|NCT01105117|BG001|Baseline|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
11010049|NCT01105117|BG002|Baseline|Total|Total of all reporting groups
11010050|NCT01105117|FG000|Participant Flow|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
11010051|NCT01105117|FG001|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
11010052|NCT01105117|OG000|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
11010053|NCT01105117|OG001|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
11010054|NCT01105117|EG000|Reported Event|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
11010055|NCT01105117|EG001|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
11010056|NCT01105130|BG000|Baseline|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
11010057|NCT01105130|BG001|Baseline|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
11010058|NCT01105130|BG002|Baseline|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
11010059|NCT01105130|BG003|Baseline|Total|Total of all reporting groups
11010060|NCT01105130|FG000|Participant Flow|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
11010061|NCT01105130|FG001|Participant Flow|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
11010062|NCT01105130|FG002|Participant Flow|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
11010063|NCT01105130|OG000|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
11010064|NCT01105130|OG001|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
11010065|NCT01105130|OG002|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
11010066|NCT01105130|EG000|Reported Event|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
11010067|NCT01105130|EG001|Reported Event|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
11010068|NCT01105130|EG002|Reported Event|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
11010069|NCT01105247|BG000|Baseline|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
11010070|NCT01105247|BG001|Baseline|Food Effect Cohort|PCI-32765: 420 mg daily
11010071|NCT01105247|BG002|Baseline|Total|Total of all reporting groups
11147914|NCT01860170|OG000|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11150171|NCT01876212|FG000|Participant Flow|Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)|"Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5).~All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours).~The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle."
11010072|NCT01105247|FG000|Participant Flow|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily.
11010073|NCT01105247|FG001|Participant Flow|Food Effect Cohort|PCI-32765: 420 mg daily
11010074|NCT01105247|OG000|Outcome|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
11010075|NCT01105247|OG001|Outcome|Food Effect|Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
11010076|NCT01105247|OG000|Outcome|Food Effect Cohort|PCI-32765: 420 mg daily
11010077|NCT01105247|OG000|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
11010078|NCT01105247|OG001|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
11010079|NCT01105247|OG002|Outcome|Food- Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
11010080|NCT01105247|OG002|Outcome|Food Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
11010081|NCT01105247|EG000|Reported Event|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
11010082|NCT01105247|EG001|Reported Event|Food Effect|PCI-32765: 420 mg daily
11010083|NCT01105312|BG000|Baseline|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010084|NCT01105312|BG001|Baseline|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010085|NCT01105312|BG002|Baseline|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010086|NCT01105312|BG003|Baseline|Total|Total of all reporting groups
11010087|NCT01105312|FG000|Participant Flow|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010088|NCT01105312|FG001|Participant Flow|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010089|NCT01105312|FG002|Participant Flow|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010090|NCT01105312|OG000|Outcome|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010091|NCT01105312|OG001|Outcome|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010092|NCT01105312|OG000|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010093|NCT01105312|EG000|Reported Event|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010094|NCT01105312|EG001|Reported Event|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010095|NCT01105312|EG002|Reported Event|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
11010096|NCT01105377|BG000|Baseline|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11010097|NCT01105377|BG001|Baseline|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11010098|NCT01105377|BG002|Baseline|Total|Total of all reporting groups
11010099|NCT01105377|FG000|Participant Flow|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11010100|NCT01105377|FG001|Participant Flow|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11010101|NCT01105377|OG000|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11010102|NCT01105377|OG001|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11010103|NCT01105377|EG000|Reported Event|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11010104|NCT01105377|EG001|Reported Event|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11010105|NCT01105533|BG000|Baseline|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
11010106|NCT01105533|FG000|Participant Flow|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
11010107|NCT01105533|FG001|Participant Flow|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
11010108|NCT01105533|FG002|Participant Flow|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
11150172|NCT01876212|FG001|Participant Flow|Vaccine + Dasatinib (Cycle 1, D1)|"Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1.~All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours).~The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle."
11010109|NCT01105533|FG003|Participant Flow|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
11010110|NCT01105533|FG004|Participant Flow|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
11010111|NCT01105533|FG005|Participant Flow|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
11010112|NCT01105533|FG006|Participant Flow|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
11010113|NCT01105533|FG007|Participant Flow|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
11010114|NCT01105533|FG008|Participant Flow|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
11010115|NCT01105533|OG000|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
11010116|NCT01105533|OG001|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
11010117|NCT01105533|OG002|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
11010118|NCT01105533|OG003|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
11010119|NCT01105533|OG004|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
11010120|NCT01105533|OG005|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
11010121|NCT01105533|OG006|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
11010122|NCT01105533|OG007|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
11010123|NCT01105533|OG008|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
11010124|NCT01105533|OG000|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
11010125|NCT01105533|EG000|Reported Event|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
11010126|NCT01105650|BG000|Baseline|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
11010127|NCT01105650|BG001|Baseline|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
11010128|NCT01105650|BG002|Baseline|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
11010129|NCT01105650|BG003|Baseline|Total|Total of all reporting groups
11010130|NCT01105650|FG000|Participant Flow|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
11010131|NCT01105650|FG001|Participant Flow|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
11147915|NCT01860170|OG001|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11010132|NCT01105650|FG002|Participant Flow|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
11010133|NCT01105650|FG003|Participant Flow|Arm 4: CsA/no Methylprednisolone/3 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin-2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 3 million units/m^2 3 times per week for 3 doses)."
11010134|NCT01105650|OG000|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
11010135|NCT01105650|OG001|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
11010136|NCT01105650|OG002|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
11010137|NCT01105650|EG000|Reported Event|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
11010138|NCT01105650|EG001|Reported Event|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
11010139|NCT01105650|EG002|Reported Event|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
11010140|NCT01105702|BG000|Baseline|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
11010141|NCT01105702|FG000|Participant Flow|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
11010142|NCT01105702|OG000|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
11010143|NCT01105702|OG000|Outcome|Grade 3|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
11010144|NCT01105702|OG001|Outcome|Grade 4|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
11010145|NCT01105702|EG000|Reported Event|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
11010146|NCT01105754|BG000|Baseline|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
11010147|NCT01105754|BG001|Baseline|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
11010148|NCT01105754|BG002|Baseline|Total|Total of all reporting groups
11010149|NCT01105754|FG000|Participant Flow|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
11010150|NCT01105754|FG001|Participant Flow|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
11010151|NCT01105754|OG000|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
11010152|NCT01105754|OG001|Outcome|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
11010153|NCT01105754|EG000|Reported Event|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
11225498|NCT02368314|FG000|Participant Flow|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
10887254|NCT00499473|FG001|Participant Flow|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
11010154|NCT01105754|EG001|Reported Event|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
11010155|NCT01105767|BG000|Baseline|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency registered disinfectants.
11010156|NCT01105767|BG001|Baseline|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
11010157|NCT01105767|BG002|Baseline|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
11010158|NCT01105767|BG003|Baseline|Total|Total of all reporting groups
11010159|NCT01105767|FG000|Participant Flow|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard standard Environmental Protection Agency registered disinfectants.
11010160|NCT01105767|FG001|Participant Flow|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
11010161|NCT01105767|FG002|Participant Flow|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
11010162|NCT01105767|OG000|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
11010163|NCT01105767|OG001|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
11010164|NCT01105767|OG002|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
11010165|NCT01105767|EG000|Reported Event|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
11010166|NCT01105767|EG001|Reported Event|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
11010167|NCT01105767|EG002|Reported Event|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
11010168|NCT01105936|BG000|Baseline|Total Participants for Baseline Measurement|All randomized participants except one were evaluated for baseline measures. One participant had misallocated treatments that could not be determined. Therefore, this participant was excluded from all populations including safety.
11066022|NCT01390818|FG003|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11010169|NCT01105936|FG000|Participant Flow|Sequence 1|Participants took part in 3 study sessions. Session 1-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
11010170|NCT01105936|FG001|Participant Flow|Sequence 2|Participants took part in 3 study sessions. Session 1-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
11010171|NCT01105936|FG002|Participant Flow|Sequence 3|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered.A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
11010172|NCT01105936|FG003|Participant Flow|Sequence 4|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
11010173|NCT01105936|OG000|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
11010174|NCT01105936|OG001|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
11010175|NCT01105936|OG002|Outcome|No Treatment|No treatment was given to participants.
11010176|NCT01105936|OG000|Outcome|Paracetamol 665 Milligram (mg)|Participants took two 665 mg Paracetamol sustained release caplets orally with 150mL of water.
11225499|NCT02368314|FG001|Participant Flow|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
11225500|NCT02368314|OG000|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
11010177|NCT01105936|EG000|Reported Event|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
11010178|NCT01105936|EG001|Reported Event|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
11010179|NCT01105936|EG002|Reported Event|No Treatment|No treatment was given to participants.
11010180|NCT01105975|BG000|Baseline|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010181|NCT01105975|BG001|Baseline|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010182|NCT01105975|BG002|Baseline|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010183|NCT01105975|BG003|Baseline|Placebo|Administered daily by mouth for 12 weeks
11010184|NCT01105975|BG004|Baseline|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
11225501|NCT02368314|OG001|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
11225502|NCT02368314|EG000|Reported Event|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
11225503|NCT02368314|EG001|Reported Event|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
11225504|NCT02368431|BG000|Baseline|Zonisamide|Men or women veterans, ages 21-70, met Diagnostic and Statistical Manual IV Text Revision (DSM-IV) criteria for current Alcohol Dependence (AD) (determined by structured clinical interview)
11225505|NCT02368431|BG001|Baseline|Placebo|Men or women veterans, ages 21-70, met Diagnostic and Statistical Manual IV Text Revision (DSM-IV) criteria for current Alcohol Dependence (AD) (determined by structured clinical interview)
11010185|NCT01105975|BG005|Baseline|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
11010186|NCT01105975|BG006|Baseline|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010187|NCT01105975|BG007|Baseline|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
11010188|NCT01105975|BG008|Baseline|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010189|NCT01105975|BG009|Baseline|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
11010190|NCT01105975|BG010|Baseline|Total|Total of all reporting groups
11010191|NCT01105975|FG000|Participant Flow|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010192|NCT01105975|FG001|Participant Flow|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010193|NCT01105975|FG002|Participant Flow|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010194|NCT01105975|FG003|Participant Flow|Placebo|Administered daily by mouth for 12 weeks
10887255|NCT00499473|OG000|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
11010195|NCT01105975|FG004|Participant Flow|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010196|NCT01105975|FG005|Participant Flow|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
11010197|NCT01105975|FG006|Participant Flow|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010198|NCT01105975|FG007|Participant Flow|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
11010199|NCT01105975|FG008|Participant Flow|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010200|NCT01105975|FG009|Participant Flow|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
11010201|NCT01105975|OG000|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010202|NCT01105975|OG001|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
11010203|NCT01105975|OG000|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010204|NCT01105975|OG001|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010205|NCT01105975|OG002|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010206|NCT01105975|OG003|Outcome|Placebo|Administered daily by mouth for 12 weeks
11010207|NCT01105975|OG000|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
11150173|NCT01876212|OG000|Outcome|Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)|"Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5).~All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours).~The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle."
11225506|NCT02368431|BG002|Baseline|Total|Total of all reporting groups
11010208|NCT01105975|OG001|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
11010209|NCT01105975|OG002|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010210|NCT01105975|OG003|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
11010211|NCT01105975|OG003|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
11010212|NCT01105975|OG004|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
11010213|NCT01105975|OG005|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
11010214|NCT01105975|OG004|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010215|NCT01105975|OG005|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
11010216|NCT01105975|OG006|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010217|NCT01105975|OG007|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
11010218|NCT01105975|OG008|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010219|NCT01105975|OG009|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
11010220|NCT01105975|EG000|Reported Event|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010221|NCT01105975|EG001|Reported Event|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010222|NCT01105975|EG002|Reported Event|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
11010223|NCT01105975|EG003|Reported Event|Placebo|Administered daily by mouth for 12 weeks
11010224|NCT01105975|EG004|Reported Event|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010225|NCT01105975|EG005|Reported Event|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
11010226|NCT01105975|EG006|Reported Event|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010227|NCT01105975|EG007|Reported Event|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
11010228|NCT01105975|EG008|Reported Event|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
11010229|NCT01105975|EG009|Reported Event|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
11010230|NCT01105975|EG010|Reported Event|30 mg LY2484595 Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
11010231|NCT01105975|EG011|Reported Event|100 mg LY2484595 Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
11010232|NCT01105975|EG012|Reported Event|500 mg LY2484595 Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
11010233|NCT01105975|EG013|Reported Event|Placebo Follow-Up|30 day follow-up period after last dose of study drug
11010234|NCT01105975|EG014|Reported Event|20 mg Atorvastatin Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
11010235|NCT01105975|EG015|Reported Event|100 mg LY2484595 + 20 mg Atorvastatin Follow-Up|30 day follow-up period after last dose of study drug
11010236|NCT01105975|EG016|Reported Event|40 mg Simvastatin Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
11010237|NCT01105975|EG017|Reported Event|100 mg LY2484595 + 40 mg Simvastatin Follow-Up|30 day follow-up period after last dose of study drug
11010238|NCT01105975|EG018|Reported Event|10 mg Rosuvastatin Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
11010239|NCT01105975|EG019|Reported Event|100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up|30 day follow-up period after last dose of study drug
11010240|NCT01106014|BG000|Baseline|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
11010241|NCT01106014|BG001|Baseline|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
11010242|NCT01106014|BG002|Baseline|Total|Total of all reporting groups
11010243|NCT01106014|FG000|Participant Flow|SELEXIPAG|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
11010244|NCT01106014|FG001|Participant Flow|PLACEBO|Matching placebo was administered orally following the same administration schedule as described for selexipag
11010245|NCT01106014|OG000|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
11010246|NCT01106014|OG001|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
11010247|NCT01106014|EG000|Reported Event|Selexipag|This group includes patients who received at least one dose of selexipag. One subject who was randomized to placebo received a single dose of 8 tablets of selexipag due to an error in the dispensation of the medication bottle. Therefore, this patient was assigned to the selexipag group in the safety analysis set.
11010248|NCT01106014|EG001|Reported Event|Placebo|This group includes patients who received at least one dose of placebo. Four patients who were randomized to placebo never received the drugs and another patient received selexipag by mistake (see Selexipag group for more details). Therefore, these patients were excluded from the placebo group in the safety analysis set.
11010249|NCT01106027|BG000|Baseline|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.~At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly."
11010250|NCT01106027|FG000|Participant Flow|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.~At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly."
11010251|NCT01106027|OG000|Outcome|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.~At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly."
11010252|NCT01106027|EG000|Reported Event|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.~At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly."
11010253|NCT01106040|BG000|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
11010254|NCT01106040|FG000|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
11010255|NCT01106040|OG000|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
11010256|NCT01106040|OG000|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
11010257|NCT01106040|EG000|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
11010258|NCT01106092|BG000|Baseline|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010259|NCT01106092|BG001|Baseline|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010260|NCT01106092|BG002|Baseline|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010261|NCT01106092|BG003|Baseline|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
11010262|NCT01106092|BG004|Baseline|Total|Total of all reporting groups
11010263|NCT01106092|FG000|Participant Flow|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010264|NCT01106092|FG001|Participant Flow|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010265|NCT01106092|FG002|Participant Flow|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010266|NCT01106092|FG003|Participant Flow|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
11010267|NCT01106092|OG000|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010268|NCT01106092|OG001|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010269|NCT01106092|OG002|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010270|NCT01106092|OG003|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
11010271|NCT01106092|EG000|Reported Event|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010272|NCT01106092|EG001|Reported Event|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010273|NCT01106092|EG002|Reported Event|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
11010274|NCT01106092|EG003|Reported Event|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
11147916|NCT01860170|OG002|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11010275|NCT01106157|BG000|Baseline|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
11010276|NCT01106157|BG001|Baseline|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
11010277|NCT01106157|BG002|Baseline|Total|Total of all reporting groups
11010278|NCT01106157|FG000|Participant Flow|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose) given subcutaneously every 2 weeks beginning after the ATG infusion."
11010279|NCT01106157|FG001|Participant Flow|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner.~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes."
11010280|NCT01106157|OG000|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
11010281|NCT01106157|OG001|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
11010282|NCT01106157|EG000|Reported Event|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
11010283|NCT01106157|EG001|Reported Event|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
11010284|NCT01106248|BG000|Baseline|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
11010285|NCT01106248|FG000|Participant Flow|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
11010286|NCT01106248|OG000|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
11010287|NCT01106248|EG000|Reported Event|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
11010288|NCT01106287|BG000|Baseline|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
11010289|NCT01106287|BG001|Baseline|MK-0941 60/80/Pbo/ MK-0941 120/140 mg|Treatment Sequence 2
11010290|NCT01106287|BG002|Baseline|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
11010291|NCT01106287|BG003|Baseline|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
11010292|NCT01106287|BG004|Baseline|Total|Total of all reporting groups
11010293|NCT01106287|FG000|Participant Flow|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
11010294|NCT01106287|FG001|Participant Flow|MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg|Treatment Sequence 2
11010295|NCT01106287|FG002|Participant Flow|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
11010296|NCT01106287|FG003|Participant Flow|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
11010297|NCT01106287|OG000|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
11010298|NCT01106287|OG001|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
11010299|NCT01106287|OG002|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
11010300|NCT01106287|OG003|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
11010301|NCT01106287|OG004|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
11010302|NCT01106287|OG005|Outcome|Placebo|All participants receiving placebo
11010303|NCT01106287|EG000|Reported Event|MK-0941 60 mg|All participants receiving at least one dose of 60 mg of MK-0941
11010304|NCT01106287|EG001|Reported Event|MK-0941 80 mg|All participants receiving at least one dose of 80 mg of MK-0941
11010305|NCT01106287|EG002|Reported Event|MK-0941 100 mg|All participants receiving at least one dose of 100 mg of MK-0941
11010306|NCT01106287|EG003|Reported Event|MK-0941 120 mg|All participants receiving at least one dose of 120 mg of MK-0941
11010307|NCT01106287|EG004|Reported Event|MK-0941 140 mg|All participants receiving at least one dose of 140 mg of MK-0941
11010308|NCT01106287|EG005|Reported Event|Placebo|All participants receiving placebo
11010309|NCT01106326|BG000|Baseline|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
11010310|NCT01106326|FG000|Participant Flow|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
11010311|NCT01106326|OG000|Outcome|Baseline|
11010312|NCT01106326|OG001|Outcome|Two Months Post Baseline|
11010313|NCT01106326|OG002|Outcome|Four Months Post Baseline|
11010314|NCT01106326|EG000|Reported Event|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
11010315|NCT01106352|BG000|Baseline|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
11225507|NCT02368431|FG000|Participant Flow|Zonisamide|"Participants received zonisamide titrated to a target dose of 500mg orally, daily, double-blind (Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose). Subjects may increase their dose to 600mg daily during the target treatment period if it is thought to be beneficial.~Zonisamide: Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose"
11225508|NCT02368431|FG001|Participant Flow|Placebo|Participants received placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group) Placebo: Placebo
11225509|NCT02368431|OG000|Outcome|Zonisamide|"Participants received zonisamide titrated to a target dose of 500mg orally, daily, double-blind (Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose). Subjects may increase their dose to 600mg daily during the target treatment period if it is thought to be beneficial.~Zonisamide: Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose"
11225510|NCT02368431|OG001|Outcome|Placebo|Participants received placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group) Placebo: Placebo
11225511|NCT02368431|EG000|Reported Event|Zonisamide|"Participants received zonisamide titrated to a target dose of 500mg orally, daily, double-blind (Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose). Subjects may increase their dose to 600mg daily during the target treatment period if it is thought to be beneficial.~Zonisamide: Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose"
11010316|NCT01106352|BG001|Baseline|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010317|NCT01106352|BG002|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010318|NCT01106352|BG003|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
11010319|NCT01106352|BG004|Baseline|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
11010320|NCT01106352|BG005|Baseline|Total|Total of all reporting groups
11010321|NCT01106352|FG000|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
11010322|NCT01106352|FG001|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010323|NCT01106352|FG002|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010324|NCT01106352|FG003|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
11225512|NCT02368431|EG001|Reported Event|Placebo|Participants received placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group) Placebo: Placebo
11225513|NCT02368457|BG000|Baseline|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
11225514|NCT02368457|BG001|Baseline|Control Group|No drug treatment
11225515|NCT02368457|BG002|Baseline|Total|Total of all reporting groups
11225516|NCT02368457|FG000|Participant Flow|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
11225517|NCT02368457|FG001|Participant Flow|Control Group|No drug treatment
11010325|NCT01106352|FG004|Participant Flow|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
11010326|NCT01106352|OG000|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
11010327|NCT01106352|OG001|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010328|NCT01106352|OG002|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010329|NCT01106352|OG003|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
11010330|NCT01106352|OG004|Outcome|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
11010331|NCT01106352|OG000|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010332|NCT01106352|OG002|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
11010333|NCT01106352|OG000|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
11010334|NCT01106352|OG001|Outcome|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
11010335|NCT01106352|EG000|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on National Institute of Standards and Technology (NIST) 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 milligram per square meter (mg/m^2) every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation
11010336|NCT01106352|EG001|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010337|NCT01106352|EG002|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
11010338|NCT01106352|EG003|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
11010339|NCT01106352|EG004|Reported Event|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks
11010340|NCT01106391|BG000|Baseline|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
11010341|NCT01106391|FG000|Participant Flow|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
11010342|NCT01106391|OG000|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
11010343|NCT01106391|EG000|Reported Event|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
11010344|NCT01106404|BG000|Baseline|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
11010345|NCT01106404|BG001|Baseline|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
11010346|NCT01106404|BG002|Baseline|Total|Total of all reporting groups
11010347|NCT01106404|FG000|Participant Flow|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
11010348|NCT01106404|FG001|Participant Flow|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
11010349|NCT01106404|OG000|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
11010350|NCT01106404|OG001|Outcome|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
11147917|NCT01860170|EG000|Reported Event|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11147918|NCT01860170|EG001|Reported Event|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11150174|NCT01876212|OG001|Outcome|Vaccine + Dasatinib (Cycle 1, D1)|"Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1.~All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours).~The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle."
11010351|NCT01106404|OG001|Outcome|6-week Manual Followed by 6-week AdaptiveStime Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
11010352|NCT01106404|OG000|Outcome|AdaptiveStim Treatment Arm|Subjects in AdaptiveStim treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim ON.
11010353|NCT01106404|OG001|Outcome|Manual Treatment Arm|Subjects in manual treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim OFF.
11010354|NCT01106404|OG000|Outcome|NPRS at Baseline (Subject With Score at 10 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
11010355|NCT01106404|OG001|Outcome|NPRS at 10 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
11010356|NCT01106404|OG002|Outcome|NPRS at Baseline (Subject With Score at 16 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
11010357|NCT01106404|OG003|Outcome|NPRS at 16 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
11010358|NCT01106404|EG000|Reported Event|Overall Adverse Events|Overall adverse events were reported.
11010359|NCT01106430|BG000|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
11010360|NCT01106430|BG001|Baseline|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
11010361|NCT01106430|BG002|Baseline|Total|Total of all reporting groups
11010362|NCT01106430|FG000|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
11010363|NCT01106430|FG001|Participant Flow|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
11010364|NCT01106430|OG000|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
11010365|NCT01106430|OG001|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
11010366|NCT01106430|EG000|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
11010367|NCT01106430|EG001|Reported Event|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
11010368|NCT01106456|BG000|Baseline|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)"
11010369|NCT01106456|BG001|Baseline|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
11010370|NCT01106456|BG002|Baseline|Total|Total of all reporting groups
11010371|NCT01106456|FG000|Participant Flow|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)"
11010372|NCT01106456|FG001|Participant Flow|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
11010373|NCT01106456|OG000|Outcome|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)."
11010374|NCT01106456|OG001|Outcome|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
11010375|NCT01106456|EG000|Reported Event|Experimental 1: All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored All Nations Breath of Life program (ANBL) or Nontailored program (NT).~Experimental 1: All Nations Breath of Life program (ANBL): ANBL consists of in-person group sessions and individual telephone calls. We have successfully conducted a pilot study of ANBL and have found very promising results. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.~Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)"
11010376|NCT01106456|EG001|Reported Event|Experimental 2: Nontailored Program (NT)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored All Nations Breath of Life program (ANBL) or Nontailored program (NT).~Experimental 2: Nontailored program (NT): The nontailored intervention includes the medicines listed above to all participants and targeted counseling delivered by non-American Indian counselors who have worked closely with the American Indian communities and respect the cultures, values, and traditions of the Indian people. Therefore, our intervention includes the current best practice recommendations for smoking cessation. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.~Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)"
11225518|NCT02368457|OG000|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
11010377|NCT01106586|BG000|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
11010378|NCT01106586|BG001|Baseline|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
11010379|NCT01106586|BG002|Baseline|Total|Total of all reporting groups
11010380|NCT01106586|FG000|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
11010381|NCT01106586|FG001|Participant Flow|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
11010382|NCT01106586|OG000|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
11010383|NCT01106586|OG001|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
11010384|NCT01106586|EG000|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
11010385|NCT01106586|EG001|Reported Event|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
11010386|NCT01106625|BG000|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010387|NCT01106625|BG001|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010388|NCT01106625|BG002|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010389|NCT01106625|BG003|Baseline|Total|Total of all reporting groups
11010390|NCT01106625|FG000|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010391|NCT01106625|FG001|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010392|NCT01106625|FG002|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010393|NCT01106625|OG000|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010394|NCT01106625|OG001|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010395|NCT01106625|OG002|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11010396|NCT01106625|EG000|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
11010397|NCT01106625|EG001|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
11010398|NCT01106625|EG002|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
11010399|NCT01106625|EG003|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
11010400|NCT01106625|EG004|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
11010401|NCT01106625|EG005|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
11010402|NCT01106651|BG000|Baseline|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11010403|NCT01106651|BG001|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11150175|NCT01876212|EG000|Reported Event|Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)|"Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5).~All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours).~The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle."
11225519|NCT02368457|OG001|Outcome|Control Group|Standard treatment
11010404|NCT01106651|BG002|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11010405|NCT01106651|BG003|Baseline|Total|Total of all reporting groups
11010406|NCT01106651|FG000|Participant Flow|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11010407|NCT01106651|FG001|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11010408|NCT01106651|FG002|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11010409|NCT01106651|OG000|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11010410|NCT01106651|OG001|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11010411|NCT01106651|OG002|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
11010412|NCT01106651|EG000|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
11010413|NCT01106651|EG001|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
11010414|NCT01106651|EG002|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
11010415|NCT01106651|EG003|Reported Event|Placebo: Baseline to Week 104|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104.
11010416|NCT01106651|EG004|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
11010417|NCT01106651|EG005|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
11010418|NCT01106677|BG000|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
11010419|NCT01106677|BG001|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010420|NCT01106677|BG002|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010421|NCT01106677|BG003|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010422|NCT01106677|BG004|Baseline|Total|Total of all reporting groups
11010423|NCT01106677|FG000|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
11010424|NCT01106677|FG001|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010425|NCT01106677|FG002|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010426|NCT01106677|FG003|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010427|NCT01106677|OG000|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
11010428|NCT01106677|OG001|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010429|NCT01106677|OG002|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010430|NCT01106677|OG003|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010431|NCT01106677|OG000|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010432|NCT01106677|OG001|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010433|NCT01106677|OG002|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
11010434|NCT01106677|EG000|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
11010435|NCT01106677|EG001|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
11010436|NCT01106677|EG002|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
11010437|NCT01106677|EG003|Reported Event|Sitagliptin 100 mg: Baseline to Week 26|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
11010438|NCT01106677|EG004|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
11010439|NCT01106677|EG005|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
11010440|NCT01106677|EG006|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
11010441|NCT01106677|EG007|Reported Event|Sitagliptin 100mg: Baseline to Week 52|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
11010442|NCT01106690|BG000|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
11010443|NCT01106690|BG001|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
11010444|NCT01106690|BG002|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
11010445|NCT01106690|BG003|Baseline|Total|Total of all reporting groups
11010446|NCT01106690|FG000|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
11010447|NCT01106690|FG001|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
11010448|NCT01106690|FG002|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
11010449|NCT01106690|OG000|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
11010450|NCT01106690|OG001|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
11010451|NCT01106690|OG002|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
11010452|NCT01106690|EG000|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 26.
11010453|NCT01106690|EG001|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
11225520|NCT02368457|OG001|Outcome|CONTROL|No drug treatment
11010454|NCT01106690|EG002|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
11010455|NCT01106690|EG003|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 52.
11010456|NCT01106690|EG004|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
11010457|NCT01106690|EG005|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
11010458|NCT01106833|BG000|Baseline|Sirolimus, Calcineurin Inhibitor, and Prednisone|"Sirolimus + calcineurin inhibitor + prednisone~Sirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~The target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
11010459|NCT01106833|BG001|Baseline|Sirolimus and Prednisone|"Sirolimus + prednisone~Sirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
11010460|NCT01106833|BG002|Baseline|Total|Total of all reporting groups
11010461|NCT01106833|FG000|Participant Flow|Sirolimus, Calcineurin Inhibitor, and Prednisone|"Sirolimus + calcineurin inhibitor + prednisone~Sirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~The target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
11010462|NCT01106833|FG001|Participant Flow|Sirolimus and Prednisone|"Sirolimus + prednisone~Sirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
11010463|NCT01106833|OG000|Outcome|Sirolimus, Calcineurin Inhibitor, and Prednisone|"Sirolimus + calcineurin inhibitor + prednisone~Sirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~The target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
11010464|NCT01106833|OG001|Outcome|Sirolimus and Prednisone|"Sirolimus + prednisone~Sirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
11010465|NCT01106833|EG000|Reported Event|Sirolimus, Calcineurin Inhibitor, and Prednisone|"Sirolimus + calcineurin inhibitor + prednisone~Sirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~The target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
11010466|NCT01106833|EG001|Reported Event|Sirolimus and Prednisone|"Sirolimus + prednisone~Sirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
11010467|NCT01106846|BG000|Baseline|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
11010468|NCT01106846|BG001|Baseline|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
11010469|NCT01106846|BG002|Baseline|Total|Total of all reporting groups
11010470|NCT01106846|FG000|Participant Flow|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
11010471|NCT01106846|FG001|Participant Flow|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
11010472|NCT01106846|OG000|Outcome|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
11010473|NCT01106846|OG001|Outcome|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
11010474|NCT01106846|EG000|Reported Event|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
11010475|NCT01106846|EG001|Reported Event|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
11010476|NCT01106859|BG000|Baseline|Total Population|All participants in this four-way cross-over study
11010477|NCT01106859|FG000|Participant Flow|Total Population|All participants in this four-way cross-over study
11010478|NCT01106859|OG000|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
11010479|NCT01106859|OG001|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
11010480|NCT01106859|OG002|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
11010481|NCT01106859|OG003|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
11010482|NCT01106859|OG001|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
11010483|NCT01106859|EG000|Reported Event|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
11010484|NCT01106859|EG001|Reported Event|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
11010485|NCT01106859|EG002|Reported Event|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
11010486|NCT01106859|EG003|Reported Event|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
11010487|NCT01106898|BG000|Baseline|Treatment (Chemotherapy With or Without Maintenance Therapy)|"SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide, paclitaxel, trastuzumab: Given IV"
11010488|NCT01106898|FG000|Participant Flow|Treatment (Chemotherapy With or Without Maintenance Therapy)|"SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide, paclitaxel, trastuzumab: Given IV"
11010489|NCT01106898|OG000|Outcome|Treatment (Chemotherapy With or Without Maintenance Therapy)|"SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide, paclitaxel, trastuzumab: Given IV"
11010490|NCT01106898|EG000|Reported Event|Treatment (Chemotherapy With or Without Maintenance Therapy)|"SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide, paclitaxel, trastuzumab: Given IV"
11150176|NCT01876212|EG001|Reported Event|Vaccine + Dasatinib (Cycle 1, D1)|"Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1.~All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours).~The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle."
11010491|NCT01106911|BG000|Baseline|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
11010492|NCT01106911|FG000|Participant Flow|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
11010493|NCT01106911|OG000|Outcome|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
11010494|NCT01106911|EG000|Reported Event|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
11010495|NCT01106950|BG000|Baseline|Evaluable (Treated) Patients|Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
11010496|NCT01106950|FG000|Participant Flow|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
11010497|NCT01106950|OG000|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
11010498|NCT01106950|OG000|Outcome|Evaluable (Treated) Patients (Expansion=No)|KIR matched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
11010499|NCT01106950|OG001|Outcome|Evaluable (Treated) Patients (Expansion=Yes)|KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
11010500|NCT01106950|EG000|Reported Event|Treated Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
11010501|NCT01106976|BG000|Baseline|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients
11010502|NCT01106976|FG000|Participant Flow|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients; Hoehn and Yahr stage 1-3) underwent [C-11]methyl-4-piperidinyl propionate (PMP) acetylcholinesterase (AChE) brain PET imaging at baseline and at 3-4 year follow-up. AChE PET imaging assesses cholinergic terminal integrity with cortical uptake reflecting largely basal forebrain neuron integrity and thalamic uptake principally reflecting pedunculopontine nucleus integrity.
11010503|NCT01106976|OG000|Outcome|Parkinson Disease|Prospective cohort study of Parkinson disease subjects.
11010504|NCT01106976|EG000|Reported Event|Parkinson|Longitudinal cohort
11010505|NCT01107015|BG000|Baseline|Group 1: Usual Care|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
11010506|NCT01107015|BG001|Baseline|Group 2: Patient Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback~Tailored Patient Intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months."
11010507|NCT01107015|BG002|Baseline|Group 3: Patient-physician Intervention|"Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook~Patient-physician intervention: . Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. PCPs are provided access to a web portal. This is raw patient data that have not been analyzed."
11010508|NCT01107015|BG003|Baseline|Group 4: Data Analyzed Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations~Patient and PCP intervention with analyzed data:Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electro"
11010509|NCT01107015|BG004|Baseline|Total|Total of all reporting groups
11010510|NCT01107015|FG000|Participant Flow|Group 1: Usual Care|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
11010511|NCT01107015|FG001|Participant Flow|Group 2: Patient Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback~Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identif"
11010512|NCT01107015|FG002|Participant Flow|Group 3: Patient-physician Intervention|"Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook~PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is raw patient data that have not be"
11225521|NCT02368457|EG000|Reported Event|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
11010513|NCT01107015|FG003|Participant Flow|Group 4: Data Analyzed Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations~Patient and PCP intervention with analyzed data: Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electro"
11010514|NCT01107015|OG000|Outcome|Group 1: Usual Care|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
11010515|NCT01107015|OG001|Outcome|Group 2: Patient Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback~Tailored Patient Intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months."
11010516|NCT01107015|OG002|Outcome|Group 3: Patient-physician Intervention|"Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook~Patient-physician intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is raw patient data that have not been analyzed."
11225522|NCT02368457|EG001|Reported Event|Control Group|Standard treatment
11225523|NCT02368691|BG000|Baseline|GTx-024|"GTx-024 capsules, 18 mg PO once-daily for up to 12 months~GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg"
11225524|NCT02368691|FG000|Participant Flow|GTx-024|"GTx-024 capsules, 18 mg PO once-daily for up to 12 months~GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg"
11225525|NCT02368691|OG000|Outcome|GTx-024|"GTx-024 capsules, 18 mg PO once-daily for up to 12 months~GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg"
11010517|NCT01107015|OG003|Outcome|Group 4: Data Analyzed Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations~Patient and PCP intervention with analyzed data: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electronic logbooks. PCPs are provided with data analysis reports. The PCP is reminded that all data analysis is based on patient-entered, unvalidated data. The PCP has the option to use this information and remains responsible for all treatment decisions."
11010518|NCT01107015|EG000|Reported Event|Group 1: Usual Care|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
11010519|NCT01107015|EG001|Reported Event|Group 2: Patient Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback~Tailored Patient Intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months."
11010520|NCT01107015|EG002|Reported Event|Group 3: Patient-physician Intervention|"Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook~Patient-physician intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is raw patient data that have not been analyzed."
11010521|NCT01107015|EG003|Reported Event|Group 4: Data Analyzed Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations~Patient and PCP intervention with analyzed data: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electronic logbooks. PCPs are provided with data analysis reports. The PCP is reminded that all data analysis is based on patient-entered, unvalidated data. The PCP has the option to use this information and remains responsible for all treatment decisions."
11010522|NCT01107197|BG000|Baseline|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
11010523|NCT01107197|BG001|Baseline|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
11010524|NCT01107197|BG002|Baseline|Total|Total of all reporting groups
11010525|NCT01107197|FG000|Participant Flow|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bottles/day (200 mL each; in 4 boluses [100 mL each] spread throughout the day) of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one for 8 weeks~Control formula : Isonitrogenous isocaloric oral formula"
11010526|NCT01107197|FG001|Participant Flow|Enriched Nutrition Formula|"Patients were given standard diet plus two bottles/day (400 mL) of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements for 8 weeks~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
11010527|NCT01107197|OG000|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
11010528|NCT01107197|OG001|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
11010529|NCT01107197|EG000|Reported Event|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
11010530|NCT01107197|EG001|Reported Event|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
11010531|NCT01107353|BG000|Baseline|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
11010532|NCT01107353|BG001|Baseline|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
11010533|NCT01107353|BG002|Baseline|Total|Total of all reporting groups
11010534|NCT01107353|FG000|Participant Flow|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
11010535|NCT01107353|FG001|Participant Flow|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
11010536|NCT01107353|OG000|Outcome|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
11010537|NCT01107353|OG001|Outcome|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
11010538|NCT01107353|EG000|Reported Event|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
11010539|NCT01107353|EG001|Reported Event|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
11010540|NCT01107379|BG000|Baseline|Balloon Catheter Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation"
11010541|NCT01107379|FG000|Participant Flow|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
11010542|NCT01107379|OG000|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
11010543|NCT01107379|EG000|Reported Event|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
11010544|NCT01107392|BG000|Baseline|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
11010545|NCT01107392|BG001|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
11010546|NCT01107392|BG002|Baseline|Total|Total of all reporting groups
11010547|NCT01107392|FG000|Participant Flow|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
11010548|NCT01107392|FG001|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
11010549|NCT01107392|OG000|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
11010550|NCT01107392|OG001|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
11010551|NCT01107392|EG000|Reported Event|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
11010552|NCT01107392|EG001|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
11066023|NCT01390818|FG004|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066024|NCT01390818|FG005|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066025|NCT01390818|FG006|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066026|NCT01390818|FG007|Participant Flow|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066027|NCT01390818|FG008|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066028|NCT01390818|FG009|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066029|NCT01390818|FG010|Participant Flow|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066030|NCT01390818|FG011|Participant Flow|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066031|NCT01390818|FG012|Participant Flow|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11150177|NCT01876251|BG000|Baseline|PF-03084014 100 mg BID + Docetaxel 75 mg/m^2|PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11010553|NCT01107405|BG000|Baseline|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
11010554|NCT01107405|BG001|Baseline|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
11010555|NCT01107405|BG002|Baseline|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
11010556|NCT01107405|BG003|Baseline|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
11010557|NCT01107405|BG004|Baseline|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
11010558|NCT01107405|BG005|Baseline|Total|Total of all reporting groups
11010559|NCT01107405|FG000|Participant Flow|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
11010560|NCT01107405|FG001|Participant Flow|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
11010561|NCT01107405|FG002|Participant Flow|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
11010562|NCT01107405|FG003|Participant Flow|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
11010563|NCT01107405|FG004|Participant Flow|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
11010564|NCT01107405|OG000|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
11010565|NCT01107405|OG001|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
11010566|NCT01107405|OG002|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
11010567|NCT01107405|OG003|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
11010568|NCT01107405|OG004|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
11010569|NCT01107405|EG000|Reported Event|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
11010570|NCT01107405|EG001|Reported Event|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
11147919|NCT01860170|EG002|Reported Event|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
11147920|NCT01860287|BG000|Baseline|Placebo Group|"Healthy volunteers receive placebo during session (within-subjects design).~Placebo: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo"
11147921|NCT01860287|BG001|Baseline|Buprenorphine (0.2 mg) Group|"Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design).~Buprenorphine 0.2 MG Sublingual Tablet: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2)"
11010571|NCT01107405|EG002|Reported Event|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
11010572|NCT01107405|EG003|Reported Event|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
11010573|NCT01107405|EG004|Reported Event|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
11010574|NCT01107418|BG000|Baseline|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010575|NCT01107418|BG001|Baseline|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010576|NCT01107418|BG002|Baseline|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010577|NCT01107418|BG003|Baseline|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010578|NCT01107418|BG004|Baseline|Total|Total of all reporting groups
11010579|NCT01107418|FG000|Participant Flow|Vemurafenib - All Cohorts|Participants received vemurafenib (RO5185426) film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 milligrams (mg) on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010580|NCT01107418|OG000|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010581|NCT01107418|OG001|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010582|NCT01107418|OG002|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010583|NCT01107418|OG003|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010584|NCT01107418|OG000|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010585|NCT01107418|OG001|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010586|NCT01107418|OG002|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010587|NCT01107418|OG003|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010588|NCT01107418|OG000|Outcome|Vemurafenib - All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010589|NCT01107418|EG000|Reported Event|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010590|NCT01107418|EG001|Reported Event|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010591|NCT01107418|EG002|Reported Event|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010592|NCT01107418|EG003|Reported Event|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
11010593|NCT01107444|BG000|Baseline|LY2181308 + Docetaxel|"LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.~Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met."
11010594|NCT01107444|BG001|Baseline|Docetaxel|Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
11010595|NCT01107444|BG002|Baseline|Total|Total of all reporting groups
11147922|NCT01860287|BG002|Baseline|Buprenorphine (0.4 mg) Group|"Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design).~Buprenorphine 0.4 MG Sublingual Tablet: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)"
11147923|NCT01860287|BG003|Baseline|Total|Total of all reporting groups
11147924|NCT01860287|FG000|Participant Flow|Placebo Group|Healthy volunteers receive placebo
11147925|NCT01860287|FG001|Participant Flow|0.2 Buprenorphine|Healthy volunteers will receive 0.2 mg of buprenorphine
11010596|NCT01107444|FG000|Participant Flow|LY2181308 + Docetaxel|"LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.~Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met."
11010597|NCT01107444|FG001|Participant Flow|Docetaxel|Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
11010598|NCT01107444|OG000|Outcome|LY2181308 + Docetaxel|"LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.~Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met."
11010599|NCT01107444|OG001|Outcome|Docetaxel|Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
11010600|NCT01107444|OG000|Outcome|LY2181308 + Docetaxel|"LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.~Docetaxel: 75 milligrams/meters squared (mg/m^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met."
11010601|NCT01107444|OG001|Outcome|Docetaxel|Docetaxel: 75 milligrams/meters squared (mg/m^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met
11010602|NCT01107444|OG001|Outcome|Docetaxel|Docetaxel: 75 milligrams/meters squared (mg/m^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
11010603|NCT01107444|EG000|Reported Event|LY2181308 + Docetaxel|"LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.~Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met."
11147926|NCT01860287|FG002|Participant Flow|0.4 mg Buprenorphine|Healthy volunteers will receive 0.4 mg of buprenorphine
11147927|NCT01860287|OG000|Outcome|Placebo Group|Healthy volunteers receive placebo
11147928|NCT01860287|OG001|Outcome|0.2 Buprenorphine|Healthy volunteers will receive 0.2 mg of buprenorphine
11147929|NCT01860287|OG002|Outcome|0.4 mg Buprenorphine|Healthy volunteers will receive 0.4 mg of buprenorphine
11147930|NCT01860287|EG000|Reported Event|Placebo Group|Healthy volunteers receive placebo
11147931|NCT01860287|EG001|Reported Event|0.2 Buprenorphine|Healthy volunteers will receive 0.2 mg of buprenorphine
11147932|NCT01860287|EG002|Reported Event|0.4 mg Buprenorphine|Healthy volunteers will receive 0.4 mg of buprenorphine
11010604|NCT01107444|EG001|Reported Event|Docetaxel|Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
11010605|NCT01107457|BG000|Baseline|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11147933|NCT01860521|BG000|Baseline|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
11147934|NCT01860521|BG001|Baseline|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
11147935|NCT01860521|BG002|Baseline|Total|Total of all reporting groups
11010606|NCT01107457|BG001|Baseline|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11010607|NCT01107457|BG002|Baseline|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11010608|NCT01107457|BG003|Baseline|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11010609|NCT01107457|BG004|Baseline|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~Administered 80 mg ixekizumab SC Q4W through week 344."
11010610|NCT01107457|BG005|Baseline|Total|Total of all reporting groups
11010611|NCT01107457|FG000|Participant Flow|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 milligrams (mg) ixekizumab given subcutaneous (SC) every 4 weeks (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11010612|NCT01107457|FG001|Participant Flow|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11010613|NCT01107457|FG002|Participant Flow|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11010614|NCT01107457|FG003|Participant Flow|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11010615|NCT01107457|FG004|Participant Flow|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~Administered 80 mg ixekizumab SC Q4W through week 344."
11010616|NCT01107457|FG005|Participant Flow|120 mg/80 mg Total Ixekizumab|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
11010617|NCT01107457|OG000|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010618|NCT01107457|OG001|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010619|NCT01107457|OG002|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010620|NCT01107457|OG003|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010621|NCT01107457|OG004|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010622|NCT01107457|OG000|Outcome|All Participants (10mg, 25mg,75mg & 150 mg Ixekizumab)|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010623|NCT01107457|OG000|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC."
11010624|NCT01107457|OG000|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
11010625|NCT01107457|EG000|Reported Event|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010626|NCT01107457|EG001|Reported Event|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010627|NCT01107457|EG002|Reported Event|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010628|NCT01107457|EG003|Reported Event|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010629|NCT01107457|EG004|Reported Event|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
11010630|NCT01107457|EG005|Reported Event|Treatment Durability|Part A: Treatment durability/safety follow-up period:12 to 20 weeks.
11010631|NCT01107457|EG006|Reported Event|120 mg and 80 mg Total Ixekizumab|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236."
11010632|NCT01107457|EG007|Reported Event|Post Treatment Safety Visits|Participants who were followed due to neutropenia.
11225526|NCT02368691|EG000|Reported Event|GTx-024|"GTx-024 capsules, 18 mg PO once-daily for up to 12 months~GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg"
11010633|NCT01107535|BG000|Baseline|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
11010634|NCT01107535|FG000|Participant Flow|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
11010635|NCT01107535|OG000|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
11010636|NCT01107535|EG000|Reported Event|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
11010637|NCT01107626|BG000|Baseline|Induction Therapy But Not Randomized|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
11010638|NCT01107626|BG001|Baseline|Arm A (Induction Then Maintenance With Bevacizumab)|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010639|NCT01107626|BG002|Baseline|Arm B (Induction Then Maintenance With Pemetrexed)|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010640|NCT01107626|BG003|Baseline|Arm C (Inductio Then Maintenance With Bevacizumab & Pemetrexed)|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010641|NCT01107626|BG004|Baseline|Total|Total of all reporting groups
11010642|NCT01107626|FG000|Participant Flow|Induction Therapy But Not Randomized to Maintenance Therapy|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
11010643|NCT01107626|FG001|Participant Flow|Arm A (Induction Then Maintenance With Bevacizumab)|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010644|NCT01107626|FG002|Participant Flow|Arm B (Induction Then Maintenance With Pemetrexed|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010645|NCT01107626|FG003|Participant Flow|Arm C (Induction Then Maintenance With Bevacizumab and Pemetrexed)|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010646|NCT01107626|OG000|Outcome|Arm A (Induction Then Maintenance With Bevacizumab)|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010647|NCT01107626|OG001|Outcome|Arm B (Induction Then Maintenance With Pemetrexed|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010648|NCT01107626|OG002|Outcome|Arm C (Induction Then Maintenance With Bevacizumab and Pemetrexed)|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010649|NCT01107626|EG000|Reported Event|Arm I (Induction Therapy - Carboplatin, Paclitaxel & Bevacizumab)|"Induction Therapy:~Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
11010650|NCT01107626|EG001|Reported Event|Arm A (Maintenance Therapy - Bevacizumab)|"Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010651|NCT01107626|EG002|Reported Event|Arm B (Maintenance Therapy - Pemetrexed)|"Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010652|NCT01107626|EG003|Reported Event|Arm C (Maintenance Therapy - Bevacizumab + Pemetrexed)|"Maintenance Therapy:~Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity."
11010653|NCT01107665|BG000|Baseline|Pazopanib and Paclitaxel|"Treatment on study will be administered in 4-week cycles. Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily.~Pazopanib and Paclitaxel: Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily."
11010654|NCT01107665|FG000|Participant Flow|Pazopanib and Paclitaxel|"Treatment on study will be administered in 4-week cycles. Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily.~Pazopanib and Paclitaxel: Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily."
11010655|NCT01107665|OG000|Outcome|Pazopanib and Paclitaxel|"Treatment on study will be administered in 4-week cycles. Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily.~Pazopanib and Paclitaxel: Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily."
11010656|NCT01107665|OG000|Outcome|BRAF Mutant Subset|Subset of subjects who are BRAF mutant positive
11010657|NCT01107665|OG001|Outcome|BRAF WT/Unknown Group|Subset of subjects who are BRAF WT or unknown status.
11010658|NCT01107665|EG000|Reported Event|Pazopanib and Paclitaxel|"Treatment on study will be administered in 4-week cycles. Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily.~Pazopanib and Paclitaxel: Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily."
11010659|NCT01107730|BG000|Baseline|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
11010660|NCT01107730|BG001|Baseline|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
11010661|NCT01107730|BG002|Baseline|Placebo|Placebo: Placebo
11010662|NCT01107730|BG003|Baseline|Total|Total of all reporting groups
11010663|NCT01107730|FG000|Participant Flow|L-Carnitine|L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
11010664|NCT01107730|FG001|Participant Flow|Vitamin C|VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
11010665|NCT01107730|FG002|Participant Flow|Placebo|Placebo: Placebo
11010666|NCT01107730|OG000|Outcome|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
11010667|NCT01107730|OG001|Outcome|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
11010668|NCT01107730|OG002|Outcome|Placebo|Placebo: Placebo
11010669|NCT01107730|EG000|Reported Event|L-Carnitine|"Carnitine 2 days preoperatively and 4 days postoperatively~Carnitine: Carnitine 2 days preoperatively and 4 days postoperatively"
11010670|NCT01107730|EG001|Reported Event|Vitamin C|"Vitamin C 2 days preoperatively and 4 days postoperatively~Vitamin C: Vitamin C 2 days preoperatively and 4 days postoperatively"
11010671|NCT01107730|EG002|Reported Event|Placebo|Placebo: Placebo
11010672|NCT01107743|BG000|Baseline|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010673|NCT01107743|FG000|Participant Flow|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010674|NCT01107743|OG000|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010675|NCT01107743|OG000|Outcome|Male|Male participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010676|NCT01107743|OG001|Outcome|Female|Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010677|NCT01107743|OG000|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010678|NCT01107743|OG001|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010679|NCT01107743|OG000|Outcome|Without Hypertension|Participants without Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010680|NCT01107743|OG001|Outcome|With Hypertension|Participants with Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010681|NCT01107743|OG000|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010682|NCT01107743|OG001|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010683|NCT01107743|OG002|Outcome|ClassⅢ|Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010684|NCT01107743|OG000|Outcome|Without Angina Pectoris|Participants without Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010685|NCT01107743|OG001|Outcome|With Angina Pectoris|Participants with Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010686|NCT01107743|OG000|Outcome|Without Hypercholesterolemia|Participants without Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010687|NCT01107743|OG001|Outcome|With Hypercholesterolemia|Participants with Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010688|NCT01107743|OG000|Outcome|Type Ⅰ|Participants with expression type Ⅰ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010689|NCT01107743|OG001|Outcome|Type Ⅱa|Participants with expression type Ⅱa Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010690|NCT01107743|OG002|Outcome|Type Ⅱb|Participants with expression type Ⅱb Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010691|NCT01107743|OG003|Outcome|Type Ⅲ|Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010692|NCT01107743|OG004|Outcome|Type Ⅳ|Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010693|NCT01107743|OG005|Outcome|Type Ⅴ|Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
11010694|NCT01107743|OG000|Outcome|Without Familial Hypercholesterolemia|Participants without Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010695|NCT01107743|OG001|Outcome|With Familial Hypercholesterolemia|Participants with Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010696|NCT01107743|OG000|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010697|NCT01107743|OG001|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010698|NCT01107743|OG000|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010699|NCT01107743|OG001|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010700|NCT01107743|OG000|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010701|NCT01107743|OG001|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010702|NCT01107743|OG000|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010703|NCT01107743|OG001|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010704|NCT01107743|OG000|Outcome|Male|Male Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
11010705|NCT01107743|OG001|Outcome|Female|Female Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
11010706|NCT01107743|OG001|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
11010707|NCT01107743|OG002|Outcome|ClassⅢ|Participants with Class Ⅲ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010708|NCT01107743|OG000|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010709|NCT01107743|OG001|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010710|NCT01107743|OG000|Outcome|Class1|Participants with Class1 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11150178|NCT01876251|BG001|Baseline|PF-03084014 100 mg BID + Docetaxel 100 mg/m^2|PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
11150179|NCT01876251|BG002|Baseline|PF-03084014 150 mg BID + Docetaxel 75 mg/m^2|PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11150180|NCT01876251|BG003|Baseline|Total|Total of all reporting groups
10885818|NCT00490568|OG000|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR..
10885819|NCT00490568|OG000|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
10885820|NCT00490568|EG000|Reported Event|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
10885821|NCT00490646|BG000|Baseline|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
10885822|NCT00490646|BG001|Baseline|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
10885823|NCT00490646|BG002|Baseline|Total|Total of all reporting groups
10885824|NCT00490646|FG000|Participant Flow|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
10885825|NCT00490646|FG001|Participant Flow|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
10885826|NCT00490646|OG000|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
10885827|NCT00490646|OG001|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
10885828|NCT00490646|EG000|Reported Event|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
10885829|NCT00490646|EG001|Reported Event|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
10885830|NCT00490698|BG000|Baseline|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
10885831|NCT00490698|FG000|Participant Flow|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
10885832|NCT00490698|OG000|Outcome|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
10885833|NCT00490698|EG000|Reported Event|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
10885834|NCT00490724|BG000|Baseline|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
10885835|NCT00490724|BG001|Baseline|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
11010711|NCT01107743|OG001|Outcome|Class2|Participants with Class2 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010712|NCT01107743|OG002|Outcome|Class3|Participants with Class3 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010713|NCT01107743|OG003|Outcome|Class4|Participants with Class4 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010714|NCT01107743|OG000|Outcome|Type Ⅰ|Participants with expression type Ⅰ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010715|NCT01107743|OG001|Outcome|Type Ⅱa|Participants with expression type Ⅱa who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010716|NCT01107743|OG002|Outcome|Type Ⅱb|Participants with expression type Ⅱb who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010717|NCT01107743|OG003|Outcome|Type Ⅲ|Participants with expression type Ⅲ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010718|NCT01107743|OG004|Outcome|Type Ⅳ|Participants with expression type Ⅳ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010719|NCT01107743|OG005|Outcome|Type Ⅴ|Participants with expression type Ⅴ who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
11010720|NCT01107743|EG000|Reported Event|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
11010721|NCT01107834|BG000|Baseline|Healthy Control|HIV-negative children born to healthy, HIV-negative women
11010722|NCT01107834|BG001|Baseline|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
11147936|NCT01860521|FG000|Participant Flow|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
11147937|NCT01860521|FG001|Participant Flow|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
11010723|NCT01107834|BG002|Baseline|Total|Total of all reporting groups
11010724|NCT01107834|FG000|Participant Flow|Healthy Control|HIV-negative children born to healthy, HIV-negative women
11010725|NCT01107834|FG001|Participant Flow|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
11010726|NCT01107834|OG000|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
11010727|NCT01107834|OG001|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
11010728|NCT01107834|EG000|Reported Event|Healthy Control|"HIV-negative children born to healthy, HIV-negative women~No adverse events"
11010729|NCT01107834|EG001|Reported Event|Exposed to HIV/HAART|"HIV-negative children exposed to HIV and HAART in utero~No adverse events"
11010730|NCT01107886|BG000|Baseline|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
11010731|NCT01107886|BG001|Baseline|Placebo|Matching Placebo
11010732|NCT01107886|BG002|Baseline|Total|Total of all reporting groups
11010733|NCT01107886|FG000|Participant Flow|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
11010734|NCT01107886|FG001|Participant Flow|Placebo|Matching Placebo
11010735|NCT01107886|OG000|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
11010736|NCT01107886|OG001|Outcome|Placebo|Matching Placebo
11010737|NCT01107886|EG000|Reported Event|Placebo|Matching Placebo
11010738|NCT01107886|EG001|Reported Event|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
11010739|NCT01107899|BG000|Baseline|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
11010740|NCT01107899|BG001|Baseline|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
11010741|NCT01107899|BG002|Baseline|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
11010742|NCT01107899|BG003|Baseline|Total|Total of all reporting groups
11010743|NCT01107899|FG000|Participant Flow|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
11010744|NCT01107899|FG001|Participant Flow|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
11010745|NCT01107899|FG002|Participant Flow|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
11010746|NCT01107899|OG000|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
11010747|NCT01107899|OG001|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
11010748|NCT01107899|OG002|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
11010749|NCT01107899|OG000|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
11010750|NCT01107899|OG001|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
11010751|NCT01107899|OG000|Outcome|All Treatments|"Clopidogrel 600 mg taken orally, day one, single dose Prasugrel 30 and 60 mg taken orally, day one, single dose~All treatments were combined into one group."
11010752|NCT01107899|EG000|Reported Event|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
11010753|NCT01107899|EG001|Reported Event|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
11010754|NCT01107899|EG002|Reported Event|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
11010755|NCT01107912|BG000|Baseline|Very Elderly, Drug Sequence ABC|Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
11010756|NCT01107912|BG001|Baseline|Very Elderly; Drug Sequence ACB|Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
11010757|NCT01107912|BG002|Baseline|Non-Elderly; Drug Sequence BAC|Participants (≥45 to <65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
11010758|NCT01107912|BG003|Baseline|Non-Elderly; Drug Sequence BCA|Participants (≥45 to <65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
10885836|NCT00490724|BG002|Baseline|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
10885837|NCT00490724|BG003|Baseline|Total|Total of all reporting groups
10885838|NCT00490724|FG000|Participant Flow|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
10885839|NCT00490724|FG001|Participant Flow|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
10885840|NCT00490724|FG002|Participant Flow|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
10885841|NCT00490724|OG000|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
10885842|NCT00490724|OG001|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
10885843|NCT00490724|OG002|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
11010759|NCT01107912|BG004|Baseline|Total|Total of all reporting groups
11010760|NCT01107912|FG000|Participant Flow|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
11010761|NCT01107912|FG001|Participant Flow|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
11010762|NCT01107912|FG002|Participant Flow|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
11010763|NCT01107912|FG003|Participant Flow|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
11010764|NCT01107912|FG004|Participant Flow|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
11010765|NCT01107912|FG005|Participant Flow|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
11010766|NCT01107912|OG000|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
11010767|NCT01107912|OG001|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
11010768|NCT01107912|OG001|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
11010769|NCT01107912|OG002|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
11010770|NCT01107912|OG003|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
11010771|NCT01107912|OG004|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
11010772|NCT01107912|OG005|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
11010773|NCT01107912|EG000|Reported Event|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
11010774|NCT01107912|EG001|Reported Event|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
11010775|NCT01107912|EG002|Reported Event|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
11010776|NCT01107912|EG003|Reported Event|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
11010777|NCT01107912|EG004|Reported Event|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
11010778|NCT01107912|EG005|Reported Event|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
11010779|NCT01107925|BG000|Baseline|Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received 5 milligrams (mg) of Prasugrel (Pras) during Study Period 1, followed by 10 mg Pras in Study Period 2, followed by 75 mg clopidogrel (Clop) in Study Period 3.
11010780|NCT01107925|BG001|Baseline|Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)|Participants in the LBW group received 5 mg Pras during Study Period 1, followed by 75 mg Clop in Study Period 2, and 10 mg Pras in Study Period 3.
11010781|NCT01107925|BG002|Baseline|Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
11010782|NCT01107925|BG003|Baseline|Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)|Participants in the HBW group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
11010783|NCT01107925|BG004|Baseline|Total|Total of all reporting groups
11010784|NCT01107925|FG000|Participant Flow|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
11010785|NCT01107925|FG001|Participant Flow|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010786|NCT01107925|FG002|Participant Flow|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
11010787|NCT01107925|FG003|Participant Flow|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010788|NCT01107925|FG004|Participant Flow|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
11010789|NCT01107925|FG005|Participant Flow|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010790|NCT01107925|OG000|Outcome|Prasugrel 5 mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received the 5-milligram (mg) prasugrel dose in Study Period 1.
11010791|NCT01107925|OG001|Outcome|Prasugrel 10 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received the 10-mg prasugrel dose in Study Period 1.
11010792|NCT01107925|OG000|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
11010793|NCT01107925|OG001|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010794|NCT01107925|OG002|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
11010795|NCT01107925|OG003|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010796|NCT01107925|OG004|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
11010797|NCT01107925|OG005|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose either during Study Period 2 or Study Period 3.
11010798|NCT01107925|OG000|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; (<60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
11010799|NCT01107925|OG005|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose during Study Period 2 or Study Period 3.
11010800|NCT01107925|OG000|Outcome|Prasugrel 5 mg (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
11010801|NCT01107925|OG001|Outcome|Prasugrel 10 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010802|NCT01107925|OG002|Outcome|Clopidogrel 75 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010803|NCT01107925|OG003|Outcome|Prasugrel 5 mg (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010804|NCT01107925|OG004|Outcome|Prasugrel 10 mg (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
11010805|NCT01107925|OG005|Outcome|Clopidogrel 75 mg (HBW)|Participants in the HBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010806|NCT01107925|OG002|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Period 1 (on 5 mg prasugrel) were switched to either the 10-mg prasugrel or the 75-mg clopidogrel dose for Period 2 or Period 3.
11010807|NCT01107925|OG003|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010808|NCT01107925|OG004|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the (HBW; ≥ 60 kg) treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
11010809|NCT01107925|OG005|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either 5-mg prasugrel or the 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010810|NCT01107925|EG000|Reported Event|5 mg Prasugrel (LBW)|During Study Period 1, participants received 5 milligrams (mg) prasugrel for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
11010811|NCT01107925|EG001|Reported Event|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010812|NCT01107925|EG002|Reported Event|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
11010813|NCT01107925|EG003|Reported Event|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 mg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010814|NCT01107925|EG004|Reported Event|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
11010815|NCT01107925|EG005|Reported Event|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
11010816|NCT01107964|BG000|Baseline|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
11010817|NCT01107964|BG001|Baseline|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
11010818|NCT01107964|BG002|Baseline|Total|Total of all reporting groups
11010819|NCT01107964|FG000|Participant Flow|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
11010820|NCT01107964|FG001|Participant Flow|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
11010821|NCT01107964|OG000|Outcome|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
11010822|NCT01107964|OG001|Outcome|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
11010823|NCT01107964|EG000|Reported Event|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
11010824|NCT01107964|EG001|Reported Event|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
11010825|NCT01108003|BG000|Baseline|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
11010826|NCT01108003|BG001|Baseline|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
11010827|NCT01108003|BG002|Baseline|Total|Total of all reporting groups
11010828|NCT01108003|FG000|Participant Flow|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
11010829|NCT01108003|FG001|Participant Flow|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
11010830|NCT01108003|OG000|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
11010831|NCT01108003|OG001|Outcome|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
11010832|NCT01108003|EG000|Reported Event|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
11010833|NCT01108003|EG001|Reported Event|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
11010834|NCT01108068|BG000|Baseline|Lithium|"patients with OPPG will be treated with lithium for 6 months~Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved."
11010835|NCT01108068|BG001|Baseline|Unaffected Controls|Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
11010836|NCT01108068|BG002|Baseline|Total|Total of all reporting groups
11010837|NCT01108068|FG000|Participant Flow|Lithium|"patients with OPPG will be treated with lithium for 6 months~Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved."
11010838|NCT01108068|FG001|Participant Flow|Unaffected Controls|Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
11010839|NCT01108068|OG000|Outcome|Lithium|"patients with OPPG will be treated with lithium for 6 months~Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved."
11010840|NCT01108068|OG001|Outcome|Unaffected Controls|Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
11010841|NCT01108068|OG000|Outcome|OPPG Rx With Lithium|Two participants who were treated with lithium and had pQCT done
11010842|NCT01108068|EG000|Reported Event|Lithium|"patients with OPPG will be treated with lithium for 6 months~Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved."
11010843|NCT01108068|EG001|Reported Event|Unaffected Controls|Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
11010844|NCT01108081|BG000|Baseline|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
11010845|NCT01108081|BG001|Baseline|Diet|"Diet~Diet: Dietary weight loss"
11010846|NCT01108081|BG002|Baseline|Health Education|"Health education~Health education: Attention control intervention"
11010847|NCT01108081|BG003|Baseline|Combined Physical Activity/Diet|Combined physical activity and diet
11010848|NCT01108081|BG004|Baseline|Total|Total of all reporting groups
11010849|NCT01108081|FG000|Participant Flow|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
11010850|NCT01108081|FG001|Participant Flow|Diet|"Diet~Diet: Dietary weight loss"
11010851|NCT01108081|FG002|Participant Flow|Health Education|"Health education~Health education: Attention control intervention"
11010852|NCT01108081|FG003|Participant Flow|Combined Physical Activity/Diet|Combined physical activity and diet
11010853|NCT01108081|OG000|Outcome|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
11010854|NCT01108081|OG001|Outcome|Diet|"Diet~Diet: Dietary weight loss"
11010855|NCT01108081|OG002|Outcome|Health Education|"Health education~Health education: Attention control intervention"
11010856|NCT01108081|OG003|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
11010857|NCT01108081|EG000|Reported Event|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
11010858|NCT01108081|EG001|Reported Event|Diet|"Diet~Diet: Dietary weight loss"
11010859|NCT01108081|EG002|Reported Event|Health Education|"Health education~Health education: Attention control intervention"
11010860|NCT01108081|EG003|Reported Event|Combined Physical Activity/Diet|Combined physical activity and diet
11010861|NCT01108094|BG000|Baseline|Cohort A1 - Itraconazole 400 mg (Vismodegib-naïve)|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants without prior vismodegib treatment (vismodegib-naïve) and more than 1 lesion at baseline.
11010862|NCT01108094|BG001|Baseline|Cohort A2 - Itraconazole 400 mg (Prior Vismodegib)|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants with prior vismodegib treatment, and more than 1 lesion at baseline.
11010863|NCT01108094|BG002|Baseline|Cohort B - Itraconazole 200 mg (Vismodegib-naïve)|Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve.
11010864|NCT01108094|BG003|Baseline|Untreated Control|Participants otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment
11010865|NCT01108094|BG004|Baseline|Total|Total of all reporting groups
11010866|NCT01108094|FG000|Participant Flow|Cohort A1 - Itraconazole 400 mg (Vismodegib-naïve)|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants without prior vismodegib treatment (vismodegib-naïve) and more than 1 lesion at baseline.
11010867|NCT01108094|FG001|Participant Flow|Cohort A2 - Itraconazole 400 mg (Prior Vismodegib)|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants with prior vismodegib treatment, and more than 1 lesion at baseline.
11010868|NCT01108094|FG002|Participant Flow|Cohort B - Itraconazole 200 mg|Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months
10885844|NCT00490724|EG000|Reported Event|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
10885845|NCT00490724|EG001|Reported Event|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
10885846|NCT00490724|EG002|Reported Event|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
10885847|NCT00490802|BG000|Baseline|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
10885848|NCT00490802|BG001|Baseline|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
10885849|NCT00490802|BG002|Baseline|Total|Total of all reporting groups
10885850|NCT00490802|FG000|Participant Flow|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
10885851|NCT00490802|FG001|Participant Flow|Placebo|Placebo Comparator : Placebo Comparator
10885852|NCT00490802|OG000|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
10885853|NCT00490802|OG001|Outcome|Placebo|Placebo Comparator : Placebo Comparator
10885854|NCT00490802|OG001|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
10885855|NCT00490802|EG000|Reported Event|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
10885856|NCT00490802|EG001|Reported Event|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
10885857|NCT00490815|BG000|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
10885858|NCT00490815|BG001|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
10885859|NCT00490815|BG002|Baseline|Total|Total of all reporting groups
10885860|NCT00490815|FG000|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant administered in one eye
10885861|NCT00490815|FG001|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant administered in one eye
10885862|NCT00490815|OG000|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
10885863|NCT00490815|OG001|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
10885864|NCT00490815|EG000|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
10885865|NCT00490815|EG001|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
10885866|NCT00490841|BG000|Baseline|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
10885867|NCT00490841|FG000|Participant Flow|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
10885868|NCT00490841|OG000|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
10885869|NCT00490841|OG000|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
10885870|NCT00490841|EG000|Reported Event|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
10885871|NCT00490919|BG000|Baseline|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
10885872|NCT00490919|BG001|Baseline|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
10885873|NCT00490919|BG002|Baseline|Total|Total of all reporting groups
10885874|NCT00490919|FG000|Participant Flow|Open-label Run-in Period|"The open-label run-in period (< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).~Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population."
10885875|NCT00490919|FG001|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
10885876|NCT00490919|FG002|Participant Flow|Double-blind Placebo TDS|Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
10885877|NCT00490919|OG000|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
10885878|NCT00490919|OG001|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
10885879|NCT00490919|EG000|Reported Event|Double-blind BTDS 10, 20|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear
11010869|NCT01108094|FG003|Participant Flow|Untreated Control|Participants otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment
11010870|NCT01108094|OG000|Outcome|Cohort A1 - Itraconazole 400 mg (Vismodegib-naïve)|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants without prior vismodegib treatment (vismodegib-naïve) and more than 1 lesion at baseline.
11010871|NCT01108094|OG001|Outcome|Cohort A2 - Itraconazole 400 mg (Prior Vismodegib)|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants with prior vismodegib treatment, and more than 1 lesion at baseline.
10885880|NCT00490919|EG001|Reported Event|Double-blind Placebo TDS 10, 20|Matching placebo TDS 10 or 20 applied for 7-day wear
10885881|NCT00490919|EG002|Reported Event|Open-label Run-in Period, BTDS 5, 10, 20|Open-label BTDS 5, 10, 20 applied for 7-day wear
10885882|NCT00490945|BG000|Baseline|Placebo|Randomized to Placebo
10885883|NCT00490945|BG001|Baseline|10 mg VEC-162|Randomized to 10 mg VEC-162
10885884|NCT00490945|BG002|Baseline|20 mg VEC-162|Randomized to 20 mg VEC-162
10885885|NCT00490945|BG003|Baseline|50 mg VEC-162|Randomized to 50 mg VEC-162
10885886|NCT00490945|BG004|Baseline|100 mg VEC-162|Randomized to 100 mg VEC-162
10885887|NCT00490945|BG005|Baseline|Total|Total of all reporting groups
10885888|NCT00490945|FG000|Participant Flow|Placebo|Randomized to Placebo
10885889|NCT00490945|FG001|Participant Flow|10 mg VEC-162|Randomized to 10 mg VEC-162
10885890|NCT00490945|FG002|Participant Flow|20 mg VEC-162|Randomized to 20 mg VEC-162
10885891|NCT00490945|FG003|Participant Flow|50 mg VEC-162|Randomized to 50 mg VEC-162
10885892|NCT00490945|FG004|Participant Flow|100 mg VEC-162|Randomized to 100 mg VEC-162
10885893|NCT00490945|OG000|Outcome|Placebo|Randomized to Placebo
10885894|NCT00490945|OG001|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
10885895|NCT00490945|OG002|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
10885896|NCT00490945|OG003|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
10885897|NCT00490945|OG004|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
10885898|NCT00490945|OG000|Outcome|Placebo*|Randomized to Placebo
10885899|NCT00490945|OG001|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162**
10885900|NCT00490945|OG000|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
10885901|NCT00490945|OG001|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
10885902|NCT00490945|OG002|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
10885903|NCT00490945|OG003|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
10885904|NCT00490945|EG000|Reported Event|Placebo|Randomized to Placebo
10885905|NCT00490945|EG001|Reported Event|10 mg VEC-162|Randomized to 10 mg VEC-162
10885906|NCT00490945|EG002|Reported Event|20 mg VEC-162|Randomized to 20 mg VEC-162
10885907|NCT00490945|EG003|Reported Event|50 mg VEC-162|Randomized to 50 mg VEC-162
10885908|NCT00490945|EG004|Reported Event|100 mg VEC-162|Randomized to 100 mg VEC-162
10885909|NCT00490971|BG000|Baseline|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
10885910|NCT00490971|BG001|Baseline|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
10885911|NCT00490971|BG002|Baseline|Total|Total of all reporting groups
10885912|NCT00490971|FG000|Participant Flow|Paliperidone Extented Release (ER)|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
10885913|NCT00490971|FG001|Participant Flow|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
10885914|NCT00490971|FG002|Participant Flow|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
10885915|NCT00490971|FG003|Participant Flow|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
10885916|NCT00490971|FG004|Participant Flow|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
10885917|NCT00490971|OG000|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
10885918|NCT00490971|OG001|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
10885919|NCT00490971|OG002|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
10885920|NCT00490971|OG003|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
10885921|NCT00490971|OG004|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
10885922|NCT00490971|EG000|Reported Event|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
10885923|NCT00490971|EG001|Reported Event|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
10885924|NCT00490971|EG002|Reported Event|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
10885925|NCT00490971|EG003|Reported Event|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
10885926|NCT00490971|EG004|Reported Event|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
10885927|NCT00491075|BG000|Baseline|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
10885928|NCT00491075|FG000|Participant Flow|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
10885929|NCT00491075|OG000|Outcome|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
11010872|NCT01108094|OG002|Outcome|Cohort B - Itraconazole 200 mg (Vismodegib-naïve)|Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve.
10885930|NCT00491075|EG000|Reported Event|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
10885931|NCT00491179|BG000|Baseline|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
10885932|NCT00491179|BG001|Baseline|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
10885933|NCT00491179|BG002|Baseline|Total|Total of all reporting groups
10885934|NCT00491179|FG000|Participant Flow|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
10885935|NCT00491179|FG001|Participant Flow|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
10885936|NCT00491179|OG000|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
10885937|NCT00491179|OG001|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
10885938|NCT00491179|EG000|Reported Event|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
10885939|NCT00491179|EG001|Reported Event|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
10885940|NCT00491244|BG000|Baseline|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
10885941|NCT00491244|BG001|Baseline|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
10885942|NCT00491244|BG002|Baseline|Total|Total of all reporting groups
10885943|NCT00491244|FG000|Participant Flow|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
10885944|NCT00491244|FG001|Participant Flow|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
10885945|NCT00491244|OG000|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
10885946|NCT00491244|OG001|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
10885947|NCT00491244|EG000|Reported Event|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
10885948|NCT00491244|EG001|Reported Event|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
10885949|NCT00491322|BG000|Baseline|Ergocalciferol Group|Ergocalciferol 50000 international units once a week for 12 weeks
10885950|NCT00491322|BG001|Baseline|Placebo Group|Matching placebo once a week for 12 weeks
10885951|NCT00491322|BG002|Baseline|Total|Total of all reporting groups
10885952|NCT00491322|FG000|Participant Flow|Ergocalciferol Group|Ergocalciferol 50000 international units once a week for 12 weeks
10885953|NCT00491322|FG001|Participant Flow|Placebo Group|Matching placebo once a week for 12 weeks
10885954|NCT00491322|OG000|Outcome|Ergocalciferol Group|Participants receiving ergocalciferol 50000 units weekly for 12 weeks
10885955|NCT00491322|OG001|Outcome|Ergocalciferol Placebo Group|Participants receiving matching ergocalciferol placebo weekly for 12 weeks
10885956|NCT00491322|EG000|Reported Event|Ergocalciferol Group|Ergocalciferol 50,000 international units once a week for 12 weeks
10885957|NCT00491322|EG001|Reported Event|Placebo Group|Matching placebo once a week for 12 weeks
10885958|NCT00491374|BG000|Baseline|Placebo|
10885959|NCT00491374|BG001|Baseline|Mometasone Furoate Nasal Spray|
10885960|NCT00491374|BG002|Baseline|Total|Total of all reporting groups
10885961|NCT00491374|FG000|Participant Flow|Placebo|
10885962|NCT00491374|FG001|Participant Flow|Mometasone Furoate Nasal Spray|
10885963|NCT00491374|OG000|Outcome|Placebo|
10885964|NCT00491374|OG001|Outcome|Mometasone Furoate Nasal Spray|
10885965|NCT00491374|EG000|Reported Event|Placebo|
10885966|NCT00491374|EG001|Reported Event|Mometasone Furoate Nasal Spray|
10885967|NCT00491491|BG000|Baseline|Z-BEAM|"ibritumomab tiuxetan (zevalin) BEAM~ibritumomab tiuxetan: 0.4 mCi/kg~BEAM chemotherapy and autologous stem-cell transplantation"
10885968|NCT00491491|BG001|Baseline|Standard BEAM|"standard BEAM chemotherapy~BEAM chemotherapy and autologous stem-cell transplantation"
10885969|NCT00491491|BG002|Baseline|Total|Total of all reporting groups
10885970|NCT00491491|FG000|Participant Flow|Z-BEAM|"ibritumomab tiuxetan (zevalin) BEAM~ibritumomab tiuxetan: 0.4 mCi/kg~BEAM chemotherapy and autologous stem-cell transplantation"
10885971|NCT00491491|FG001|Participant Flow|Standard BEAM|"standard BEAM chemotherapy~BEAM chemotherapy and autologous stem-cell transplantation"
10885972|NCT00491491|OG000|Outcome|Z-BEAM|"ibritumomab tiuxetan (zevalin) BEAM~ibritumomab tiuxetan: 0.4 mCi/kg~BEAM chemotherapy and autologous stem-cell transplantation"
10885973|NCT00491491|OG001|Outcome|Standard BEAM|"standard BEAM chemotherapy~BEAM chemotherapy and autologous stem-cell transplantation"
11147938|NCT01860521|OG000|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
11147939|NCT01860521|OG001|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
11150181|NCT01876251|FG000|Participant Flow|PF-03084014 100 mg BID + Docetaxel 75 mg/m^2|PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11150182|NCT01876251|FG001|Participant Flow|PF-03084014 100 mg BID + Docetaxel 100 mg/m^2|PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
10885974|NCT00491491|EG000|Reported Event|Z-BEAM|"ibritumomab tiuxetan (zevalin) BEAM~ibritumomab tiuxetan: 0.4 mCi/kg~BEAM chemotherapy and autologous stem-cell transplantation"
10885975|NCT00491491|EG001|Reported Event|Standard BEAM|"standard BEAM chemotherapy~BEAM chemotherapy and autologous stem-cell transplantation"
10885976|NCT00491530|BG000|Baseline|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885977|NCT00491530|BG001|Baseline|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885978|NCT00491530|BG002|Baseline|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885979|NCT00491530|BG003|Baseline|Total|Total of all reporting groups
10885980|NCT00491530|FG000|Participant Flow|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885981|NCT00491530|FG001|Participant Flow|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885982|NCT00491530|FG002|Participant Flow|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885983|NCT00491530|OG000|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885984|NCT00491530|OG001|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885985|NCT00491530|OG002|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885986|NCT00491530|EG000|Reported Event|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885987|NCT00491530|EG001|Reported Event|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10885988|NCT00491530|EG002|Reported Event|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
10887256|NCT00499473|OG001|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
10887257|NCT00499473|EG000|Reported Event|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
11010873|NCT01108094|OG003|Outcome|Untreated Control|Participants otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment.
11010874|NCT01108094|OG002|Outcome|Cohort B - Itraconazole 200 mg (Vismodegib-naïve)|Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve, and had more than 1 lesion at baseline.
11010875|NCT01108094|OG003|Outcome|Untreated Control|Participants otherwise eligible but unwilling to take itraconazole were enrolled onto this study control arm, and received no treatment.
11010876|NCT01108094|OG000|Outcome|Cohort A1 - Itraconazole 400 mg, (Vismodegib-naïve)|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants without prior vismodegib treatment (vismodegib-naïve) and more than 1 lesion at baseline.
11010877|NCT01108094|OG002|Outcome|Cohort B - Itraconazole 200 mg (Vismodegib-naïve)|Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve, and had more than 1 lesion at baseline..
11010878|NCT01108094|EG000|Reported Event|Cohort A1 - Itraconazole 400 mg +/- Prior Vismodegib|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month.
11010879|NCT01108094|EG001|Reported Event|Cohort A2 - Itraconazole 400 mg (Prior Vismodegib)|Oral itraconazole 400 mg as 200 mg twice daily, for 1 month.
11010880|NCT01108094|EG002|Reported Event|Cohort B - Itraconazole 200 mg (Vismodegib-naïve)|Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve.
11010881|NCT01108185|BG000|Baseline|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
11010882|NCT01108185|FG000|Participant Flow|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
11010883|NCT01108185|OG000|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
11010884|NCT01108185|EG000|Reported Event|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
11010885|NCT01108237|BG000|Baseline|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
11010886|NCT01108237|BG001|Baseline|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
11010887|NCT01108237|BG002|Baseline|Total|Total of all reporting groups
11010888|NCT01108237|FG000|Participant Flow|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
11010889|NCT01108237|FG001|Participant Flow|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
11010890|NCT01108237|OG000|Outcome|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
11010891|NCT01108237|OG001|Outcome|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
11010892|NCT01108237|EG000|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
11010893|NCT01108237|EG001|Reported Event|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
11010894|NCT01108263|BG000|Baseline|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
11010895|NCT01108263|BG001|Baseline|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
11010896|NCT01108263|BG002|Baseline|Total|Total of all reporting groups
11010897|NCT01108263|FG000|Participant Flow|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
11010898|NCT01108263|FG001|Participant Flow|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
11010899|NCT01108263|OG000|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
11010900|NCT01108263|OG001|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
11010901|NCT01108263|EG000|Reported Event|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
11010902|NCT01108263|EG001|Reported Event|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
11010903|NCT01108341|BG000|Baseline|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
11010904|NCT01108341|FG000|Participant Flow|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
11010905|NCT01108341|OG000|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
11010906|NCT01108341|EG000|Reported Event|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
11010907|NCT01108406|BG000|Baseline|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
11010908|NCT01108406|FG000|Participant Flow|Sonitus SoundBite System|Long Term Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
11010909|NCT01108406|OG000|Outcome|Number of Participants Experiencing no Adverse Events|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Dental measurements included periodontal measurements (bone loss, oral health, bleeding index, calculus, peridontal probing) at baseline compared to 6 months. Audiological included hearing evaluation and aided thresholds baseline compared to 6 months and medical compared medical and ear health baseline compared to 6 months.
11010910|NCT01108406|OG000|Outcome|Global Benefit APHAB Score Aided 3 Months|The Global Benefit APHAB at 3 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 3 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
11147940|NCT01860521|EG000|Reported Event|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
11147941|NCT01860521|EG001|Reported Event|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
11147942|NCT01860534|BG000|Baseline|Eye Patches Initially Then no Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
11010911|NCT01108406|OG001|Outcome|Global Benefit APHAB Score Aided 6 Months|The Global Benefit APHAB at 6 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 6 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
11010912|NCT01108406|EG000|Reported Event|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
11010913|NCT01108445|BG000|Baseline|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
11010914|NCT01108445|BG001|Baseline|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
11010915|NCT01108445|BG002|Baseline|Total|Total of all reporting groups
11010916|NCT01108445|FG000|Participant Flow|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
11010917|NCT01108445|FG001|Participant Flow|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
11010918|NCT01108445|OG000|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
11010919|NCT01108445|OG001|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
11010920|NCT01108445|EG000|Reported Event|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
11010921|NCT01108445|EG001|Reported Event|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
11010922|NCT01108458|BG000|Baseline|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
11010923|NCT01108458|FG000|Participant Flow|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
11010924|NCT01108458|OG000|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
11010925|NCT01108458|EG000|Reported Event|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
11010926|NCT01108510|BG000|Baseline|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
11010927|NCT01108510|BG001|Baseline|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
11010928|NCT01108510|BG002|Baseline|Total|Total of all reporting groups
11010929|NCT01108510|FG000|Participant Flow|ATV+COBI+FTC/TDF|Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
11010930|NCT01108510|FG001|Participant Flow|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
11010931|NCT01108510|OG000|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
11147943|NCT01860534|BG001|Baseline|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
11010932|NCT01108510|OG001|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
11010933|NCT01108510|EG000|Reported Event|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
11010934|NCT01108510|EG001|Reported Event|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
11010935|NCT01108718|BG000|Baseline|Subjects Who Receive Tempur-Pedic Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
11010936|NCT01108718|BG001|Baseline|Subjects Who Receive the Control Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
11010937|NCT01108718|BG002|Baseline|Total|Total of all reporting groups
11010938|NCT01108718|FG000|Participant Flow|Subjects Who Received the Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.
11010939|NCT01108718|FG001|Participant Flow|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic mattress.
11010940|NCT01108718|OG000|Outcome|All Participants|All subjects used a tempur-pedic mattress and control mattress to sleep on in a cross over design for a period of 2 months per mattress.
11010941|NCT01108718|EG000|Reported Event|Subjects Who Received Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
11010942|NCT01108718|EG001|Reported Event|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
11010943|NCT01108731|BG000|Baseline|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
11010944|NCT01108731|BG001|Baseline|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
11010945|NCT01108731|BG002|Baseline|Total|Total of all reporting groups
11010946|NCT01108731|FG000|Participant Flow|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
11010947|NCT01108731|FG001|Participant Flow|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
11010948|NCT01108731|OG000|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
11010949|NCT01108731|OG001|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
11010950|NCT01108731|EG000|Reported Event|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
11010951|NCT01108731|EG001|Reported Event|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
11010952|NCT01108757|BG000|Baseline|Drug|"Bactrim: Bactrim DS BID for 3 days~Demographics data by group not available as this study was discontinued in 2013. Currently randomization data not available for reassessment."
11010953|NCT01108757|BG001|Baseline|Placebo|Placebo: Corn starch capsules
11010954|NCT01108757|BG002|Baseline|Total|Total of all reporting groups
11010955|NCT01108757|FG000|Participant Flow|Drug|Bactrim: Bactrim DS BID for 3 days
11147944|NCT01860534|BG002|Baseline|Total|Total of all reporting groups
11147945|NCT01860534|FG000|Participant Flow|Eye Patch Initially Then no Eye Patch|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
11147946|NCT01860534|FG001|Participant Flow|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
11147947|NCT01860534|OG000|Outcome|Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
11010956|NCT01108757|FG001|Participant Flow|Placebo|Placebo: Corn starch capsules
11010957|NCT01108757|OG000|Outcome|Drug|Bactrim: Bactrim DS BID for 3 days
11010958|NCT01108757|OG001|Outcome|Placebo|Placebo: Corn starch capsules
11010959|NCT01108757|EG000|Reported Event|Drug|Bactrim: Bactrim DS BID for 3 days
11010960|NCT01108757|EG001|Reported Event|Placebo|Placebo: Corn starch capsules
11010961|NCT01108796|BG000|Baseline|Micardis® (Telmisartan)|Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
11010962|NCT01108796|BG001|Baseline|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
11010963|NCT01108796|BG002|Baseline|Tool (With Lifestyle Education Tool on Weight Reduction)|
11010964|NCT01108796|BG003|Baseline|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
11010965|NCT01108796|BG004|Baseline|Total|Total of all reporting groups
11010966|NCT01108796|FG000|Participant Flow|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
11010967|NCT01108796|FG001|Participant Flow|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
11010968|NCT01108796|OG000|Outcome|Micardis® (Telmisartan)|
11010969|NCT01108796|OG001|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
11010970|NCT01108796|OG002|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
11010971|NCT01108796|OG003|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
11010972|NCT01108796|EG000|Reported Event|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
11010973|NCT01108796|EG001|Reported Event|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
11010974|NCT01108809|BG000|Baseline|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
11010975|NCT01108809|FG000|Participant Flow|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
11010976|NCT01108809|OG000|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
11010977|NCT01108809|OG000|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
11010978|NCT01108809|EG000|Reported Event|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
11010979|NCT01108835|BG000|Baseline|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
11010980|NCT01108835|BG001|Baseline|Control Group|Control arm with usual care
11010981|NCT01108835|BG002|Baseline|Total|Total of all reporting groups
11010982|NCT01108835|FG000|Participant Flow|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
11010983|NCT01108835|FG001|Participant Flow|Control Group|Control arm with usual care
11010984|NCT01108835|OG000|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
11010985|NCT01108835|OG001|Outcome|Control Group|Control arm with usual care
11010986|NCT01108835|OG000|Outcome|Comprehensive Care Programme|"Comprehensive care involving multidisciplinary input.~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
11010987|NCT01108835|EG000|Reported Event|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
11010988|NCT01108835|EG001|Reported Event|Control Group|Control arm with usual care
11010989|NCT01109056|BG000|Baseline|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
11010990|NCT01109056|BG001|Baseline|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
11010991|NCT01109056|BG002|Baseline|Total|Total of all reporting groups
11010992|NCT01109056|FG000|Participant Flow|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
11147948|NCT01860534|OG001|Outcome|no Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
11010993|NCT01109056|FG001|Participant Flow|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
11010994|NCT01109056|OG000|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
11010995|NCT01109056|OG001|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
11010996|NCT01109056|EG000|Reported Event|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
11010997|NCT01109056|EG001|Reported Event|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
11010998|NCT01109069|BG000|Baseline|A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh|A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg).
11010999|NCT01109069|FG000|Participant Flow|A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH|A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg).
11011000|NCT01109069|OG000|Outcome|A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH|A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg).
11011001|NCT01109069|OG000|Outcome|IBRUTINIB/PCI-32765|This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.
11011002|NCT01109069|EG000|Reported Event|IBRUTINIB/PCI-32765|This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.
11066032|NCT01390818|FG013|Participant Flow|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066033|NCT01390818|FG014|Participant Flow|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066034|NCT01390818|OG000|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066035|NCT01390818|OG001|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066036|NCT01390818|OG002|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066037|NCT01390818|OG003|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066038|NCT01390818|OG004|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066039|NCT01390818|OG005|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066040|NCT01390818|OG006|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066041|NCT01390818|OG007|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066042|NCT01390818|OG008|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066043|NCT01390818|OG009|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066044|NCT01390818|OG010|Outcome|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066045|NCT01390818|OG000|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11011003|NCT01109108|BG000|Baseline|Children 0<2 Years of Age|Children 0<2 years of age with and without concurrent respiratory tract infection
11011004|NCT01109108|BG001|Baseline|Children 2<5 Years of Age|Children 2<5 years of age with and without concurrent respiratory tract infection
11011005|NCT01109108|BG002|Baseline|Total|Total of all reporting groups
11011006|NCT01109108|FG000|Participant Flow|Children 0<2 Years of Age|Children 0<2 years of age with and without respiratory tract infection
11011007|NCT01109108|FG001|Participant Flow|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
11011008|NCT01109108|OG000|Outcome|Children 0<2 Years of Age|Children 0<2 years of age with and without respiratory tract infection
11011009|NCT01109108|OG001|Outcome|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
11011010|NCT01109108|EG000|Reported Event|Children <2 Years of Age|Children <2 years of age with and without respiratory tract infection
11011011|NCT01109108|EG001|Reported Event|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
11147949|NCT01860534|OG000|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
11011012|NCT01109147|BG000|Baseline|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
11011013|NCT01109147|BG001|Baseline|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
11011014|NCT01109147|BG002|Baseline|Control|healthy volunteers
11011015|NCT01109147|BG003|Baseline|Total|Total of all reporting groups
11011016|NCT01109147|FG000|Participant Flow|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
11011017|NCT01109147|FG001|Participant Flow|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
11011018|NCT01109147|FG002|Participant Flow|Control|healthy volunteers
11011019|NCT01109147|OG000|Outcome|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
11150183|NCT01876251|FG002|Participant Flow|PF-03084014 150 mg BID + Docetaxel 75 mg/m^2|PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11011020|NCT01109147|OG001|Outcome|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
11011021|NCT01109147|OG002|Outcome|Control|healthy volunteers
11011022|NCT01109147|EG000|Reported Event|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
11011023|NCT01109147|EG001|Reported Event|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
11011024|NCT01109147|EG002|Reported Event|Control|healthy volunteers
11011025|NCT01109173|BG000|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
11011026|NCT01109173|BG001|Baseline|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
11011027|NCT01109173|BG002|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
11011028|NCT01109173|BG003|Baseline|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
11011029|NCT01109173|BG004|Baseline|Total|Total of all reporting groups
11011030|NCT01109173|FG000|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
11011031|NCT01109173|FG001|Participant Flow|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
11011032|NCT01109173|FG002|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
11011033|NCT01109173|FG003|Participant Flow|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
11011034|NCT01109173|OG000|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
11011035|NCT01109173|OG001|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
11011036|NCT01109173|OG002|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
11011037|NCT01109173|OG003|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
11011038|NCT01109173|EG000|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
11011039|NCT01109173|EG001|Reported Event|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
11011040|NCT01109173|EG002|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
11011041|NCT01109173|EG003|Reported Event|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
11011042|NCT01109316|BG000|Baseline|Sequence A (L2D/L6D/A6D)|Participants received Insulin Lispro 2D (2 Days), Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D.
11011043|NCT01109316|BG001|Baseline|Sequence B (L2D/A6D/L6D)|"Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:~Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D."
11011044|NCT01109316|BG002|Baseline|Sequence C (L6D/L2D/A6D)|Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D.
11011045|NCT01109316|BG003|Baseline|Sequence D (L6D/A6D/L2D)|"Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:~Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D."
11011046|NCT01109316|BG004|Baseline|Sequence E (A6D/L2D/L6D)|Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D.
11011047|NCT01109316|BG005|Baseline|Sequence F (A6D/L6D/L2D)|Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D.
11011048|NCT01109316|BG006|Baseline|Total|Total of all reporting groups
11011049|NCT01109316|FG000|Participant Flow|Sequence A (L2D/L6D/A6D)|Participants received Insulin Lispro 2D (L2D (Days)), Insulin Lispro 6D (L6D) and Insulin Aspart 6D (A6D) as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D
11011050|NCT01109316|FG001|Participant Flow|Sequence B (L2D/A6D/L6D)|"Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:~Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D."
11011051|NCT01109316|FG002|Participant Flow|Sequence C (L6D/L2D/A6D)|Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D.
11011052|NCT01109316|FG003|Participant Flow|Sequence D (L6D/A6D/L2D)|"Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:~Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D."
11011053|NCT01109316|FG004|Participant Flow|Sequence E (A6D/L2D/L6D)|Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D.
11011054|NCT01109316|FG005|Participant Flow|Sequence F (A6D/L6D/L2D)|Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D.
11011055|NCT01109316|OG000|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
11011056|NCT01109316|OG001|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
11150184|NCT01876251|OG000|Outcome|PF-03084014 100 mg BID + Docetaxel 75 mg/m^2|PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11011057|NCT01109316|OG002|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
11011058|NCT01109316|EG000|Reported Event|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
11011059|NCT01109316|EG001|Reported Event|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
11011060|NCT01109316|EG002|Reported Event|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
11011061|NCT01109381|BG000|Baseline|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
11011062|NCT01109381|FG000|Participant Flow|GT08|"Initial phase - omeprazole, N-acetylcysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
11011063|NCT01109381|OG000|Outcome|Treatment With GT08|"Initial phase - omeprazole, N-acetyl cysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 means treatment with omeprazole 40mg daily, lauric acid 150-300mg daily, and NAC 1.2 - 2g daily"
11011064|NCT01109381|OG000|Outcome|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
11011065|NCT01109381|OG000|Outcome|Treatment|"Initial phase - omeprazole, NAC (N-acetyl cysteine), lauric acid with dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
11011066|NCT01109381|EG000|Reported Event|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
11011067|NCT01109524|BG000|Baseline|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
11011068|NCT01109524|FG000|Participant Flow|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
11011069|NCT01109524|OG000|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
11011070|NCT01109524|EG000|Reported Event|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter squared (m²), week 1, then 250mg/m² weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped the treatment. One hour of observation required after each infusion. IV cisplatin, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles. Pre-cisplatin hydration could begin during 1-hour post cetuximab observation period. IV vinorelbine, 80mg/m², Day 1 of each 21 day cycle, maximum 6 cycles. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
11011071|NCT01109576|BG000|Baseline|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
11011072|NCT01109576|FG000|Participant Flow|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.~Participant Flow Completed: Twelve participants completed the entire protocol, including all outcomes measures."
11011073|NCT01109576|OG000|Outcome|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
11011074|NCT01109576|EG000|Reported Event|DSL Workshop Participants|"Dual Sensory Loss (DSL) workshop participants. Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
11147950|NCT01860534|OG001|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
11150185|NCT01876251|OG001|Outcome|PF-03084014 100 mg BID + Docetaxel 100 mg/m^2|PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
11150186|NCT01876251|OG002|Outcome|PF-03084014 150 mg BID + Docetaxel 75 mg/m^2|PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11011075|NCT01109602|BG000|Baseline|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
11011076|NCT01109602|BG001|Baseline|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
11011077|NCT01109602|BG002|Baseline|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
11011078|NCT01109602|BG003|Baseline|Total|Total of all reporting groups
11147951|NCT01860534|EG000|Reported Event|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
11147952|NCT01860534|EG001|Reported Event|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
11147953|NCT01860573|BG000|Baseline|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
11147954|NCT01860573|BG001|Baseline|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
11147955|NCT01860573|BG002|Baseline|Total|Total of all reporting groups
11147956|NCT01860573|FG000|Participant Flow|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
11147957|NCT01860573|FG001|Participant Flow|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
11147958|NCT01860573|OG000|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
11147959|NCT01860573|OG001|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
11147960|NCT01860573|EG000|Reported Event|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
11147961|NCT01860573|EG001|Reported Event|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
11147962|NCT01860586|BG000|Baseline|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
11147963|NCT01860586|FG000|Participant Flow|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
11147964|NCT01860586|OG000|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
11147965|NCT01860586|OG000|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
11147966|NCT01860586|EG000|Reported Event|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
11147967|NCT01860651|BG000|Baseline|Web-monitoring|"There is two arms for intervention:~Study 1) Patients in treatment with medicine administrated at home and Study 2) patients in treatment with biologicals."
11147968|NCT01860651|BG001|Baseline|Control|"Study 1) Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.~Study 2) Patients in treatment with biologicals: retrospective routine treatment algorithm"
11147969|NCT01860651|BG002|Baseline|Total|Total of all reporting groups
11011079|NCT01109602|FG000|Participant Flow|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
11011080|NCT01109602|FG001|Participant Flow|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
11011081|NCT01109602|FG002|Participant Flow|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
11011082|NCT01109602|OG000|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
11011083|NCT01109602|OG001|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
11011084|NCT01109602|EG000|Reported Event|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
11011085|NCT01109602|EG001|Reported Event|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
11011086|NCT01109602|EG002|Reported Event|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
11011087|NCT01109849|BG000|Baseline|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation"
11011088|NCT01109849|BG001|Baseline|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
11011089|NCT01109849|BG002|Baseline|Total|Total of all reporting groups
11011090|NCT01109849|FG000|Participant Flow|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation"
11011091|NCT01109849|FG001|Participant Flow|ER Stimulant|"daily use of 12 hour extended release (ER) methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
11011092|NCT01109849|FG002|Participant Flow|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
11011093|NCT01109849|FG003|Participant Flow|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
11011094|NCT01109849|FG004|Participant Flow|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
11011095|NCT01109849|OG000|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation~medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
11011096|NCT01109849|OG001|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
11011097|NCT01109849|OG000|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
11011098|NCT01109849|OG000|Outcome|Weight Promotion Treatment- Caloric Supplement|"Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals- either increased monitoring of growth, caloric supplement or drug holiday where only use ADHD medication for school~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm~increased monitoring of growth: monthly weight, height and BMI checks~drug holiday: switch from seven day a week dosing to medication only on school days~caloric supplement: continue current ADHD regimen and add one 8oz liquid caloric supplement at night"
11011099|NCT01109849|OG000|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation"
11011100|NCT01109849|OG001|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm Med group allowed to participate in initial basic parent training course Additional Behavioral therapy services allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
11011101|NCT01109849|OG000|Outcome|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
11011102|NCT01109849|OG001|Outcome|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
11011103|NCT01109849|OG002|Outcome|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
11011104|NCT01109849|OG000|Outcome|Consistent Medication|participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44, 29.5% female) used med <12.5% of the study duration (with most using not at all). The consistent med group used med for at least 87.5% of their time in the study with most using the entire time.
11011105|NCT01109849|OG001|Outcome|Inconsistent Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The inconsistent med group used med at least 12.5% of the time in the study but less than 87.5% of the time in the study (mean usage was 45% of time in study).
11011106|NCT01109849|OG002|Outcome|Rare Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rare med group used med <12.5% of the study duration (with most using not at all).
11011107|NCT01109849|OG000|Outcome|Caloric Supplementation|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and used caloric supplementation for at least the majority of the days in the weight recovery phase.~This arm also consisted of monthly weight checks, continuation of a daily extended release stimulant."
11011108|NCT01109849|OG001|Outcome|Drug Holiday|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were previously using medication on the majority of non school days but then stopped using medication on the majority of non school days.~This arm also consisted of monthly weight checks and use of ER stimulant on school days only."
11011109|NCT01109849|OG002|Outcome|Monitoring|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were randomly assigned to 1 of 3 weight recovery treatments and did not change their frequency of medication use after the weight recovery randomization (either used the majority of non school days pre and post randomization or did not use med the majority of non school days pre and post randomization).~This arm also consisted of monthly weight checks."
11011110|NCT01109849|EG000|Reported Event|Behavior Therapy|"Participants completing a baseline assessment and at least one post baseline assessment of adverse events and were initially assigned to behavior arm which included a basic parenting intervention, additional advanced 8 week parent training intervention, monthly boosters, option for individual parent training sessions, and a school consultant assigned to each subject.~Medication usage allowed after month 6 if at least moderately impaired~includes all participants with at least one post baseline assessment of adverse events"
11011111|NCT01109849|EG001|Reported Event|ER Stimulant|"Participants completing a baseline assessment and at least one post baseline assessment of adverse events who were initially assigned to daily use of extended release CNS Stimulant~All study medication was prescribed to be taken daily for duration of study unless assigned to weight promotion drug holiday arm~includes all participants with at least one post baseline assessment of adverse events"
11011112|NCT01109849|EG002|Reported Event|Dose Optimzed|This arm includes the 142 participants that had their dose of study medication systematically optimized through assessment of efficacy and tolerability at home and school. There participants could have come from either of the other two arms- initially assigned to either med or behavior. We added this post hoc arm as a subset of participants randomized to med never used med and a subset of behavior randomized participants did use medication. This group reports adverse event rates only in participants who used med for a sufficient duration to have their dose optimized.
11011113|NCT01109940|BG000|Baseline|Dose Group 1|Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011114|NCT01109940|BG001|Baseline|Dose Group 2|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011115|NCT01109940|BG002|Baseline|Dose Group 3|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011116|NCT01109940|BG003|Baseline|Secukinumab/Placebo|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received placebo in the core study (CAIN457A2209 [NCT00809159]).
11011117|NCT01109940|BG004|Baseline|Total|Total of all reporting groups
11011118|NCT01109940|FG000|Participant Flow|Dose Group 1|Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011119|NCT01109940|FG001|Participant Flow|Dose Group 2|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011120|NCT01109940|FG002|Participant Flow|Dose Group 3|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011121|NCT01109940|FG003|Participant Flow|Secukinumab/Placebo|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received placebo in the core study (CAIN457A2209 [NCT00809159]).
11147970|NCT01860651|FG000|Participant Flow|Web-monitoring|"There is two arms for intervention:~1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals.~Web-monitoring: During the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC."
11011122|NCT01109940|OG000|Outcome|Dose Group 1|Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011123|NCT01109940|OG001|Outcome|Dose Group 2|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011124|NCT01109940|OG002|Outcome|Dose Group 3|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011125|NCT01109940|OG003|Outcome|Secukinumab/Placebo|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received placebo in the core study (CAIN457A2209 [NCT00809159]).
11011126|NCT01109940|EG000|Reported Event|Dose Group-1|Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011127|NCT01109940|EG001|Reported Event|Dose Group-2|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011128|NCT01109940|EG002|Reported Event|Dose Group-3|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
11011129|NCT01109940|EG003|Reported Event|Placebo/Secukinumab|Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received placebo in the core study (CAIN457A2209 [NCT00809159]).
11011130|NCT01109979|BG000|Baseline|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
11011131|NCT01109979|BG001|Baseline|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
11011132|NCT01109979|BG002|Baseline|Total|Total of all reporting groups
11011133|NCT01109979|FG000|Participant Flow|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
11011134|NCT01109979|FG001|Participant Flow|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
11011135|NCT01109979|OG000|Outcome|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
11011136|NCT01109979|OG001|Outcome|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
11011137|NCT01109979|EG000|Reported Event|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
11011138|NCT01109979|EG001|Reported Event|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
11011139|NCT01109992|BG000|Baseline|Regadenoson|"Regadenoson Rubidium-82 Positron Emission Tomography~Regadenoson: Regadenoson Rubidium-82 Positron Emission Tomography"
11011140|NCT01109992|BG001|Baseline|Exercise + Regadenoson|"Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography~Exercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography"
11011141|NCT01109992|BG002|Baseline|Total|Total of all reporting groups
11011142|NCT01109992|FG000|Participant Flow|Regadenoson|"Regadenoson Rubidium-82 Positron Emission Tomography~Regadenoson Rubidium-82 Positron Emission Tomography"
11011143|NCT01109992|FG001|Participant Flow|Exercise + Regadenoson|"Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography~Exercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography"
11011144|NCT01109992|OG000|Outcome|Regadenoson (Lexiscan)|"Regadenoson Rubidium-82 Positron Emission Tomography~Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography."
11011145|NCT01109992|OG001|Outcome|Exercise + Regadenoson (Lexercise)|"Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography~Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography"
11011146|NCT01109992|OG000|Outcome|Regadenoson (Lexiscan)|"Regadenoson Rubidium-82 Positron Emission Tomography~Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.~No adverse events"
11011147|NCT01109992|OG001|Outcome|Exercise + Regadenoson (Lexiscan)|"Exercise plus Regadenoson (Lexiscan) Rubidium-82 Positron Emission Tomography~Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography~No adverse events"
11011148|NCT01109992|OG001|Outcome|Exercise + Regadenoson (Lexercise)|"Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography~Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography~No adverse events"
11011149|NCT01109992|EG000|Reported Event|Regadenoson (Lexiscan)|"Regadenoson Rubidium-82 Positron Emission Tomography~Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography"
11011150|NCT01109992|EG001|Reported Event|Exercise + Regadenoson (Lexiscan)|"Exercise plus Regadenoson (Lexiscan) Rubidium-82 Positron Emission Tomography~Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography"
11011151|NCT01110005|BG000|Baseline|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
11011152|NCT01110005|BG001|Baseline|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
11011153|NCT01110005|BG002|Baseline|Total|Total of all reporting groups
11011154|NCT01110005|FG000|Participant Flow|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
11011155|NCT01110005|FG001|Participant Flow|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
11011156|NCT01110005|OG000|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
11011157|NCT01110005|OG001|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
11011158|NCT01110005|EG000|Reported Event|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
11011159|NCT01110005|EG001|Reported Event|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
11011160|NCT01110135|BG000|Baseline|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
11011161|NCT01110135|FG000|Participant Flow|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
11011162|NCT01110135|OG000|Outcome|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
11066046|NCT01390818|OG001|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066047|NCT01390818|OG002|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066048|NCT01390818|OG003|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066049|NCT01390818|OG004|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11011163|NCT01110135|EG000|Reported Event|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
11011164|NCT01110187|BG000|Baseline|IV LCM|patients randomized to IV LCM (7)
11011165|NCT01110187|BG001|Baseline|IV fPHT|patients randomized to IV fPHT (4)
11011166|NCT01110187|BG002|Baseline|Total|Total of all reporting groups
11011167|NCT01110187|FG000|Participant Flow|IV LCM|"Patients with severe TBI later randomized to seizure prophylaxis with LCM (Lacosamide). For IV LCM dosing and adjustment see Intervention section."
11011168|NCT01110187|FG001|Participant Flow|IV fPHT|"Patients randomized to fPHT (fos-phenytoin) with moderate or severe TBI. For IV fPHT dosing and adjustment see Intervention section."
11011169|NCT01110187|OG000|Outcome|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
11011170|NCT01110187|OG001|Outcome|IV fPHT|Patients with severe TBI randomized to seizure prophylaxis with fPHT
11011171|NCT01110187|OG000|Outcome|IV LCM|"Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.~lacosamide: 200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose."
11011172|NCT01110187|OG001|Outcome|IV fPHT|"Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin~Fosphenytoin: 20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days"
11011173|NCT01110187|EG000|Reported Event|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
11011174|NCT01110187|EG001|Reported Event|IV fPHT|Patients with severe TBI later randomized to seizure prophylaxis with phenytoin.
11011175|NCT01110200|BG000|Baseline|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
11011176|NCT01110200|BG001|Baseline|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
11011177|NCT01110200|BG002|Baseline|Total|Total of all reporting groups
11011178|NCT01110200|FG000|Participant Flow|FSC 250/50|Participants (par.) self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
11011179|NCT01110200|FG001|Participant Flow|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
11011180|NCT01110200|OG000|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
11011181|NCT01110200|OG001|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
11011182|NCT01110200|EG000|Reported Event|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
11011183|NCT01110200|EG001|Reported Event|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
11011184|NCT01110239|BG000|Baseline|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
11011185|NCT01110239|BG001|Baseline|5 Min Ischemia|
11011186|NCT01110239|BG002|Baseline|7.5 Min Ischemia|
11011187|NCT01110239|BG003|Baseline|10 Min Ischemia|
11011188|NCT01110239|BG004|Baseline|Total|Total of all reporting groups
11011189|NCT01110239|FG000|Participant Flow|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes. A sham preconditioning group was added with only minimal cuff inflation.
11011190|NCT01110239|FG001|Participant Flow|5-min Ischemia|
11011191|NCT01110239|FG002|Participant Flow|7.5-min Ischemia|
11011192|NCT01110239|FG003|Participant Flow|10-min Ischemia|
11011193|NCT01110239|OG000|Outcome|Sham Preconditioning|leg preconditioning with increasing durations of ischemia divided into 4 groups: sham preconditioning 3 cycles of 5min blood pressure cuff application 3 times 5 min cycles 3 times 7.5 min cycles 3 times 10 min cycles
11011194|NCT01110239|OG001|Outcome|5 Min Ischemia|
11011195|NCT01110239|OG002|Outcome|7.5 Min Ischemia|
11011196|NCT01110239|OG003|Outcome|10 Min Ischemia|
11011197|NCT01110239|OG000|Outcome|Sham Preconditioning|Limb preconditioning intervention at increasing durations of ischemia: 5, 7.5 and 10 min.
11011198|NCT01110239|EG000|Reported Event|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
11011199|NCT01110239|EG001|Reported Event|5 Min Ischemia|
11011200|NCT01110239|EG002|Reported Event|7.5 Min Ischemia|
11011201|NCT01110239|EG003|Reported Event|10 Min Ischemia|
11011202|NCT01110252|BG000|Baseline|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
11011203|NCT01110252|FG000|Participant Flow|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
11011204|NCT01110252|OG000|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
11011205|NCT01110252|OG001|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
11011206|NCT01110252|EG000|Reported Event|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
11011207|NCT01110330|BG000|Baseline|Placebo|A topical white homogenous cream identical in appearance to study drug
11011208|NCT01110330|BG001|Baseline|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
11011209|NCT01110330|BG002|Baseline|Ketoconazole|Ketoconazole 2% cream (formulation F126)
11011210|NCT01110330|BG003|Baseline|Total|Total of all reporting groups
11011211|NCT01110330|FG000|Participant Flow|Placebo|A topical white homogenous cream identical in appearance to study drug
11011212|NCT01110330|FG001|Participant Flow|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
11011213|NCT01110330|FG002|Participant Flow|Ketoconazole|Ketoconazole 2% cream (formulation F126)
11011214|NCT01110330|OG000|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
11011215|NCT01110330|OG001|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
11011216|NCT01110330|OG002|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
11011217|NCT01110330|EG000|Reported Event|Ketoconazole|Ketoconazole 2% cream (formulation F126)
11147971|NCT01860651|FG001|Participant Flow|Control|"Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.~Patients in treatment with biologicals: routine treatment algorithm"
11147972|NCT01860651|OG000|Outcome|Web-monitoring|"Patients in treatment with medicine administrated at home~Web-monitoring: During the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC."
11011218|NCT01110330|EG001|Reported Event|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
11011219|NCT01110330|EG002|Reported Event|Placebo|A topical white homogenous cream identical in appearance to study drug
11011220|NCT01110382|BG000|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
11011221|NCT01110382|BG001|Baseline|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
11011222|NCT01110382|BG002|Baseline|Total|Total of all reporting groups
11011223|NCT01110382|FG000|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
11011224|NCT01110382|FG001|Participant Flow|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
11011225|NCT01110382|OG000|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
11011226|NCT01110382|OG001|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
11011227|NCT01110382|EG000|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
11147973|NCT01860651|OG001|Outcome|Control|Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
11011228|NCT01110382|EG001|Reported Event|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
11011229|NCT01110395|BG000|Baseline|Heart Failure|Magnetic Resonance Spectroscopy
11011230|NCT01110395|FG000|Participant Flow|Transplant|Patients with post-OHT
11011231|NCT01110395|OG000|Outcome|MR Spectroscopy Post-Heart Transplant|"Patients post heart transplant getting heart biopsy~MR Spectroscopy: MR spectroscopy of myocardial"
11011232|NCT01110395|EG000|Reported Event|Post-Heart Transplant|"Patients post heart transplant getting heart biopsy~MR Spectroscopy: MR spectroscopy for myocardial lipid"
11011233|NCT01110408|BG000|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011234|NCT01110408|BG001|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011235|NCT01110408|BG002|Baseline|Total|Total of all reporting groups
11147974|NCT01860651|OG000|Outcome|Control|Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
11147975|NCT01860651|OG001|Outcome|Web-monitoring|"Patients in treatment with medicine administrated at home~Web-monitoring: During the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC."
11011236|NCT01110408|FG000|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011237|NCT01110408|FG001|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011238|NCT01110408|OG000|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011239|NCT01110408|OG001|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011240|NCT01110408|EG000|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011241|NCT01110408|EG001|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011242|NCT01110421|BG000|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011243|NCT01110421|BG001|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011244|NCT01110421|BG002|Baseline|Total|Total of all reporting groups
11011245|NCT01110421|FG000|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011246|NCT01110421|FG001|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011247|NCT01110421|OG000|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11147976|NCT01860651|OG000|Outcome|Web-monitoring|"There is two arms for intervention:~1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals.~Web-monitoring: During the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC."
11147977|NCT01860651|OG001|Outcome|Control|"Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.~Patients in treatment with biologicals: routine treatment algorithm"
11011248|NCT01110421|OG001|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011249|NCT01110421|EG000|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11147978|NCT01860651|OG000|Outcome|Web-monitoring|Patients in treatment with biologicals.
11147979|NCT01860651|OG001|Outcome|Control|Patients in treatment with biologicals: retrospective routine treatment algorithm
11011250|NCT01110421|EG001|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
11011251|NCT01110434|BG000|Baseline|Topiramate|"Topiramate (200 mg daily)~Topiramate: Topiramate (200 mg daily)"
11011252|NCT01110434|BG001|Baseline|Sugar Pill|Placebo: Placebo (daily)
11011253|NCT01110434|BG002|Baseline|Total|Total of all reporting groups
11011254|NCT01110434|FG000|Participant Flow|Topiramate|"Topiramate (200 mg daily)~Topiramate: Topiramate (200 mg daily)"
11011255|NCT01110434|FG001|Participant Flow|Sugar Pill|Placebo: Placebo (daily)
11011256|NCT01110434|OG000|Outcome|Topiramate|"Topiramate (200 mg daily)~Topiramate: Topiramate (200 mg daily)"
11011257|NCT01110434|OG001|Outcome|Sugar Pill|Placebo: Placebo (daily)
11011258|NCT01110434|EG000|Reported Event|Topiramate|"Topiramate (200 mg daily)~Topiramate: Topiramate (200 mg daily)"
11011259|NCT01110434|EG001|Reported Event|Sugar Pill|Placebo: Placebo (daily)
11011260|NCT01110499|BG000|Baseline|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011261|NCT01110499|BG001|Baseline|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011262|NCT01110499|BG002|Baseline|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11147980|NCT01860651|EG000|Reported Event|Web-monitoring|"There is two arms for intervention:~1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals.~Web-monitoring: During the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC."
11011263|NCT01110499|BG003|Baseline|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011264|NCT01110499|BG004|Baseline|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011265|NCT01110499|BG005|Baseline|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011266|NCT01110499|BG006|Baseline|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
11011267|NCT01110499|BG007|Baseline|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
11011268|NCT01110499|BG008|Baseline|Total|Total of all reporting groups
11011269|NCT01110499|FG000|Participant Flow|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011270|NCT01110499|FG001|Participant Flow|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011271|NCT01110499|FG002|Participant Flow|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011272|NCT01110499|FG003|Participant Flow|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011273|NCT01110499|FG004|Participant Flow|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011274|NCT01110499|FG005|Participant Flow|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011275|NCT01110499|FG006|Participant Flow|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
11011276|NCT01110499|FG007|Participant Flow|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
11011277|NCT01110499|OG000|Outcome|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye once daily for 7 days.
11011278|NCT01110499|OG001|Outcome|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye once daily for 7 days.
11011279|NCT01110499|OG002|Outcome|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye once daily for 7 days.
11011280|NCT01110499|OG003|Outcome|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye once daily for 7 days.
11011281|NCT01110499|OG004|Outcome|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye once daily for 7 days.
11011282|NCT01110499|OG005|Outcome|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye once daily for 7 days.
11011283|NCT01110499|OG006|Outcome|Part 1, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in the other eye in all Part 1 treatment groups once daily for 7 days.
11011284|NCT01110499|OG000|Outcome|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
11011285|NCT01110499|OG001|Outcome|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
11011286|NCT01110499|EG000|Reported Event|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011287|NCT01110499|EG001|Reported Event|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011288|NCT01110499|EG002|Reported Event|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011289|NCT01110499|EG003|Reported Event|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011290|NCT01110499|EG004|Reported Event|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011291|NCT01110499|EG005|Reported Event|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
11011292|NCT01110499|EG006|Reported Event|Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye|bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined).
11011293|NCT01110499|EG007|Reported Event|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
11011294|NCT01110499|EG008|Reported Event|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
11011295|NCT01110681|BG000|Baseline|Solesta|"Open label.~Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) : Submucosal injections. Re-treatment is allowed one month after initial treatment if the subject is still incontinent."
11011296|NCT01110681|FG000|Participant Flow|Solesta|"Open label.~Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) : Submucosal injections. Re-treatment is allowed one month after initial treatment if the subject is still incontinent."
11011297|NCT01110681|OG000|Outcome|Solesta|"Open label.~Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) : Submucosal injections. Re-treatment is allowed one month after initial treatment if the subject is still incontinent."
11011298|NCT01110681|EG000|Reported Event|Solesta|"Open label.~Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) : Submucosal injections. Re-treatment is allowed one month after initial treatment if the subject is still incontinent."
11066050|NCT01390818|OG005|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
10885989|NCT00491556|BG000|Baseline|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
10885990|NCT00491556|BG001|Baseline|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.~Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
10885991|NCT00491556|BG002|Baseline|Total|Total of all reporting groups
10885992|NCT00491556|FG000|Participant Flow|Experimental-Early Initiation of HAART (EXP)|Began HAART consisting of TDF/FTC/ATV/r (preferred regimen), AZT/3TC/ATV/r, or other recommended NRTI HAART backbone with ATV/r upon entry to study. Subjects who achieved virologic control by week 24 (viral load (VL) < 100 copies/ml) and maintained good control through 48 weeks then entered deintensification (de-int) to ATV/r alone and were followed for two years.
10885993|NCT00491556|FG001|Participant Flow|Standard Care (STAND)|Began HAART with ATV/r under the current DHHS guidelines (CD4+ T cells below 350 cells/mm3 or for other clinical concerns as outlined in the recommendations and as determined by the site clinician).
10885994|NCT00491556|OG000|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
10885995|NCT00491556|OG000|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
10885996|NCT00491556|EG000|Reported Event|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
10885997|NCT00491556|EG001|Reported Event|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.~Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
10885998|NCT00491608|BG000|Baseline|rThrombin|Participants who received at least 1 application of rThrombin during spinal or vascular surgery (arterial reconstruction or PAB,or AV vascular access procedure and had seronegative baseline rThrombin antibody status
10885999|NCT00491608|FG000|Participant Flow|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
10886000|NCT00491608|OG000|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
10886001|NCT00491608|EG000|Reported Event|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
10886002|NCT00491751|BG000|Baseline|Atorvastatin|Atorvastatin 40 or 80 mg
11011299|NCT01110707|BG000|Baseline|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
11011300|NCT01110707|BG001|Baseline|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
11011301|NCT01110707|BG002|Baseline|Total|Total of all reporting groups
11011302|NCT01110707|FG000|Participant Flow|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
11011303|NCT01110707|FG001|Participant Flow|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
11011304|NCT01110707|OG000|Outcome|r-hFSH + r-hLH|GONAL-f (follitropin alpha); a recombinant human follicular stimulating hormone (r-hFSH) injection 300-450 International Units (IU) subcutaneously (SC) was administered separately after achieving pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a) at a dose of 0.1 milligram per day (mg/day). Subjects also received Luveris; recombinant human luteinizing hormone (r-hLH) injection 150 IU/day SC until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
11011305|NCT01110707|OG001|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
11011306|NCT01110707|OG000|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
11011307|NCT01110707|EG000|Reported Event|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
11011308|NCT01110707|EG001|Reported Event|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
11011309|NCT01110876|BG000|Baseline|Phase I Group 1: Vorinostat + Erlotinib + Temozolomide|"Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide~Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m2 orally once daily on Days 1-7 and 15-21."
11011310|NCT01110876|BG001|Baseline|Phase II Part A 3-Drug Combination|"Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study.~Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m2 orally once daily on Days 1-7 and 15-21."
11011311|NCT01110876|BG002|Baseline|Total|Total of all reporting groups
11011312|NCT01110876|FG000|Participant Flow|Phase I: Vorinostat + Erlotinib + Temozolomide|"Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide~Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21."
11011313|NCT01110876|FG001|Participant Flow|Phase II Part A 3-Drug Combination|"Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study.~Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m^2 orally once daily on Days 1-7 and 15-21."
11011314|NCT01110876|OG000|Outcome|Phase I Group 1: Vorinostat + Erlotinib + Temozolomide|"Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide~Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21."
11147981|NCT01860651|EG001|Reported Event|Control|"Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.~Patients in treatment with biologicals: retrospective routine treatment algorithm"
10886003|NCT00491751|BG001|Baseline|Ascorbic Acid|Ascorbic Acid 500 mg per day
11011315|NCT01110876|EG000|Reported Event|Phase I Dose 0: Vorinostat 200 mg + Temozolomide 125 mg/m^2|"Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide~Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21."
11011316|NCT01110876|EG001|Reported Event|Phase I Dose -1: Vorinostat 200 mg + Temozolomide 100 mg/m^2|"Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide~Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg twice daily on Days 1-21; Temozolomide 100 mg/m^2 orally once daily on Days 1-7 and 15-21."
11011317|NCT01110876|EG002|Reported Event|Phase I EIACs: Vorinostat 400 mg + Temozolomide 125 mg/m^2|"Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide for participant on enzyme inducing anticonvulsants (EIACs):~Vorinostat 400 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 100 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21."
11011318|NCT01110876|EG003|Reported Event|Phase II 3-Drug Combination|"Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study.~Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m^2 orally once daily on Days 1-7 and 15-21."
11011319|NCT01110915|BG000|Baseline|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
11011320|NCT01110915|BG001|Baseline|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
11011321|NCT01110915|BG002|Baseline|Total|Total of all reporting groups
11011322|NCT01110915|FG000|Participant Flow|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
11011323|NCT01110915|FG001|Participant Flow|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
11011324|NCT01110915|OG000|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
11011325|NCT01110915|OG001|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
11011326|NCT01110915|OG000|Outcome|Implanted Subjects|Any subject who underwent a successful implant of the Advisa MRI system.
11147982|NCT01860677|BG000|Baseline|All Study Participants|All of the study participants
11011327|NCT01110915|EG000|Reported Event|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
11147983|NCT01860677|FG000|Participant Flow|Active First, Then Sham|"Active treatment first, then Sham~Active:~The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator~Sham:~Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
11011328|NCT01110915|EG001|Reported Event|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
11011329|NCT01110967|BG000|Baseline|Patients Implanted With a Satellite Device|
11011330|NCT01110967|FG000|Participant Flow|Patients Implanted With a Satellite Device|
11011331|NCT01110967|OG000|Outcome|Patients Implanted With a Satellite Device|
11011332|NCT01110967|EG000|Reported Event|Patients Implanted With a Satellite Device|
11011333|NCT01111058|BG000|Baseline|Everolimus (RAD001)|"Subjects will receive Everolimus 10 mg daily~Everolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first)."
11011334|NCT01111058|BG001|Baseline|Placebo|"Subjects will receive double-blind placebo~Placebo"
11011335|NCT01111058|BG002|Baseline|Total|Total of all reporting groups
11011336|NCT01111058|FG000|Participant Flow|Everolimus (RAD001)|"Subjects will receive Everolimus 10 mg daily~Everolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first)."
11011337|NCT01111058|FG001|Participant Flow|Placebo|"Subjects will receive double-blind placebo~Placebo"
11011338|NCT01111058|OG000|Outcome|Everolimus (RAD001)|"Subjects will receive Everolimus 10 mg daily~Everolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first)."
11011339|NCT01111058|OG001|Outcome|Placebo|"Subjects will receive double-blind placebo~Placebo"
11011340|NCT01111058|EG000|Reported Event|Everolimus (RAD001)|"Subjects will receive Everolimus 10 mg daily~Everolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first)."
11011341|NCT01111058|EG001|Reported Event|Placebo|"Subjects will receive double-blind placebo~Placebo"
11011342|NCT01111123|BG000|Baseline|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
11011343|NCT01111123|BG001|Baseline|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
11011344|NCT01111123|BG002|Baseline|Total|Total of all reporting groups
11011345|NCT01111123|FG000|Participant Flow|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
11011346|NCT01111123|FG001|Participant Flow|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
11150187|NCT01876251|OG001|Outcome|PF-03084014 150 mg BID + Docetaxel 75 mg/m^2|PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11011347|NCT01111123|OG000|Outcome|Ammonium Lactate + Ultravate|ammonium lactate twice daily everyday plus ultravte ointment twice daily on weekends only for up to 24 weeks
11011348|NCT01111123|OG001|Outcome|Ammoium Lactate + Placebo|ammonium lactate twice daily everyday plus placebo ointment twice daily weekends only
11011349|NCT01111123|OG000|Outcome|Lac-hydrin + Ultravate|ammonium lactate twice daily everyday + ultravate twice daily weekends only
11011350|NCT01111123|OG001|Outcome|Lac-hydrin + Placebo|lac hydrin twice daily everyday plus placebo ointment twice daily weekends only
11011351|NCT01111123|EG000|Reported Event|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
11011352|NCT01111123|EG001|Reported Event|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
11011353|NCT01111149|BG000|Baseline|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
11011354|NCT01111149|BG001|Baseline|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
11011355|NCT01111149|BG002|Baseline|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
11011356|NCT01111149|BG003|Baseline|Total|Total of all reporting groups
11147984|NCT01860677|FG001|Participant Flow|Sham First, Then Active|"Sham first, then Active treatment~Active:~The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator~Sham:~Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
11150188|NCT01876251|EG000|Reported Event|PF-03084014 100 mg BID + Docetaxel 75 mg/m^2|PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11011357|NCT01111149|FG000|Participant Flow|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
11011358|NCT01111149|FG001|Participant Flow|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
11011359|NCT01111149|FG002|Participant Flow|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
11011360|NCT01111149|OG000|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
11011361|NCT01111149|OG001|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
11011362|NCT01111149|OG002|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
11011363|NCT01111149|EG000|Reported Event|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
11011364|NCT01111149|EG001|Reported Event|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
11011365|NCT01111149|EG002|Reported Event|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
11011366|NCT01111162|BG000|Baseline|Vaccination Group (Single Arm Study)|All participants
11011367|NCT01111162|FG000|Participant Flow|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
11147985|NCT01860677|OG000|Outcome|Active Stimulation|"The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
11011368|NCT01111162|OG000|Outcome|Vacinees|
11011369|NCT01111162|OG000|Outcome|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
11011370|NCT01111162|EG000|Reported Event|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
11011371|NCT01111240|BG000|Baseline|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
11011372|NCT01111240|FG000|Participant Flow|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
11011373|NCT01111240|OG000|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
11011374|NCT01111240|EG000|Reported Event|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
11011375|NCT01111292|BG000|Baseline|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11011376|NCT01111292|BG001|Baseline|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11011377|NCT01111292|BG002|Baseline|Total|Total of all reporting groups
11011378|NCT01111292|FG000|Participant Flow|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11011379|NCT01111292|FG001|Participant Flow|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11011380|NCT01111292|OG000|Outcome|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11011381|NCT01111292|OG001|Outcome|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11011382|NCT01111292|EG000|Reported Event|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11011383|NCT01111292|EG001|Reported Event|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11011384|NCT01111318|BG000|Baseline|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
11011385|NCT01111318|BG001|Baseline|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
11011386|NCT01111318|BG002|Baseline|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
11011387|NCT01111318|BG003|Baseline|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
11011388|NCT01111318|BG004|Baseline|Total|Total of all reporting groups
11011389|NCT01111318|FG000|Participant Flow|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
11011390|NCT01111318|FG001|Participant Flow|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
11011391|NCT01111318|FG002|Participant Flow|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
11011392|NCT01111318|FG003|Participant Flow|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
11011393|NCT01111318|OG000|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
10886004|NCT00491751|BG002|Baseline|Placebo|Placebo atorvastatin and Placebo ascorbic acid
11011394|NCT01111318|OG001|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
11147986|NCT01860677|OG001|Outcome|Sham Stimulation|"Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
11147987|NCT01860677|OG000|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
11147988|NCT01860677|EG000|Reported Event|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
11147989|NCT01860677|EG001|Reported Event|Sham Stimulation|Participants are outfitted with a device that is identical in appearance but does not deliver any current.
11147990|NCT01860703|BG000|Baseline|All Subjects|Subjects in this cross-over study all received one dose of each the following: A) a maximum therapeutic dose of 33 mg deferiprone, B) a supratherapeutic dose of 50 mg/kg deferiprone, C) placebo, and D) moxifloxacin (active control). They were randomized to receive these products in different orders: ABCD, BDAC, CADB, or DCBA. Treatments were separated by a 7-day washout period.
11147991|NCT01860703|FG000|Participant Flow|ABCD|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A = single oral dose of 33 mg/kg deferiprone Treatment B = single oral dose of 50 mg/kg deferiprone Treatment C = single oral dose of placebo Treatment D = single oral dose of moxifloxacin"
11147992|NCT01860703|FG001|Participant Flow|BDAC|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B = single oral dose of 50 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment A = single oral dose of 33 mg/kg deferiprone Treatment C = single oral dose of placebo"
11147993|NCT01860703|FG002|Participant Flow|CADB|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C = single oral dose of placebo Treatment A = single oral dose of 33 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment B = single oral dose of 50 mg/kg deferiprone"
11147994|NCT01860703|FG003|Participant Flow|DCBA|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D = single oral dose of moxifloxacin Treatment C = single oral dose of placebo Treatment B = single oral dose of 50 mg/kg deferiprone Treatment A = single oral dose of 33 mg/kg deferiprone"
11147995|NCT01860703|OG000|Outcome|33 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
11147996|NCT01860703|OG001|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
11147997|NCT01860703|OG000|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
11147998|NCT01860703|OG001|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
11147999|NCT01860703|OG002|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
11148000|NCT01860703|OG003|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
11148001|NCT01860703|OG000|Outcome|50 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
11148002|NCT01860703|OG001|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
11148003|NCT01860703|OG002|Outcome|Arm C - Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
11148004|NCT01860703|OG000|Outcome|Positive Control|A single 400 mg tablet of moxifloxacin. The tablet was administered orally with approximately 240 mL of water.
11011395|NCT01111318|OG002|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
11011396|NCT01111318|OG003|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
11011397|NCT01111318|EG000|Reported Event|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
11011398|NCT01111318|EG001|Reported Event|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
11011399|NCT01111318|EG002|Reported Event|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
11011400|NCT01111318|EG003|Reported Event|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
11011401|NCT01111331|BG000|Baseline|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, cross-over, open-label trial consisting of three treatments. 18 patients were randomised to one of two possible treatment sequences. The three treatments were~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1"
11011402|NCT01111331|FG000|Participant Flow|Empa / Empa Plus Warfarin / Warfarin|"Patients received three treatments in the following order~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1~There was a washout period of at least 14 days between the second and third treatment periods."
11011403|NCT01111331|FG001|Participant Flow|Warfarin / Empa / Empa Plus Warfarin|"Patients received three treatments in the following order~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~There was a washout period of at least 14 days between the first and second treatment periods."
11011404|NCT01111331|OG000|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
11011405|NCT01111331|OG001|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
11011406|NCT01111331|OG000|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
11011407|NCT01111331|OG001|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
11011408|NCT01111331|OG002|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
11011409|NCT01111331|EG000|Reported Event|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
11011410|NCT01111331|EG001|Reported Event|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
11011411|NCT01111331|EG002|Reported Event|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
11011412|NCT01111370|BG000|Baseline|Continuous Glucose Monitoring System|The Dexcom G4 Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
11011413|NCT01111370|FG000|Participant Flow|Continuous Glucose Monitoring System|DexCom™ G4 Continuous Glucose Monitoring System : Continuous Glucose Monitoring System, that is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
11011414|NCT01111370|OG000|Outcome|CGM Device|DexCom™ G4 Continuous Glucose Monitoring System
11011415|NCT01111370|EG000|Reported Event|Real Time Continuous Glucose Monitoring System|"continuous glucose monitoring system~DexCom™ G4 Continuous Glucose Monitoring System: Continuous Glucose Monitoring System"
10886005|NCT00491751|BG003|Baseline|Total|Total of all reporting groups
11011416|NCT01111461|BG000|Baseline|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
11011417|NCT01111461|FG000|Participant Flow|Lenvatinib 24 mg|Lenvatinib hard capsules, 24 mg (two 10-mg capsules and one 4-mg capsule) were self-administered orally once a day in the morning (without regard to food intake) in 28-day cycles. Dose reduction or interruption was allowed for participants who experienced lenvatinib-related toxicity.
11011418|NCT01111461|OG000|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
11011419|NCT01111461|EG000|Reported Event|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
11011420|NCT01111474|BG000|Baseline|All Study Participants|"In this split mouth study, teeth from the participants were randomly assigned according to quadrants, to either receive Cyanoacrylate (Superbonder) or Laser (LILT).~Cyanoacrylate: 3 applications of Superbonder (48 hours interval) at the cervical region of the sensitive tooth. LILT: 3 Low intensity laser application (48 hour interval). The application of 1Joules/cm^2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (795nm)"
11066051|NCT01390818|OG006|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
10886006|NCT00491751|FG000|Participant Flow|Atorvastatin|Atorvastatin 40 or 80 mg
10886007|NCT00491751|FG001|Participant Flow|Ascorbic Acid|Ascorbic Acid 500 mg per day
10886008|NCT00491751|FG002|Participant Flow|Placebo|Placebo atorvastatin and Placebo ascorbic acid
10886009|NCT00491751|OG000|Outcome|Atorvastatin|Atorvastatin 40 or 80 mg
10886010|NCT00491751|OG001|Outcome|Ascorbic Acid|Ascorbic Acid 500 mg per day
10886011|NCT00491751|OG002|Outcome|Placebo|Placebo atorvastatin and Placebo ascorbic acid
10886012|NCT00491751|OG000|Outcome|CVD Event|All subjects with a cardiovascular event regardless of treatment group.
10886013|NCT00491751|OG001|Outcome|No CVD Event|All subjects without a cardiovascular event regardless of treatment group.
10886014|NCT00491751|EG000|Reported Event|Atorvastatin|Atorvastatin 40 or 80 mg
10886015|NCT00491751|EG001|Reported Event|Ascorbic Acid|Ascorbi acid 500 mg [per day
10886016|NCT00491751|EG002|Reported Event|Placebo|Placebo for atorvastatin and ascorbic acid
10886017|NCT00491764|BG000|Baseline|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
10886018|NCT00491764|BG001|Baseline|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
10886019|NCT00491764|BG002|Baseline|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
10886020|NCT00491764|BG003|Baseline|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
11011421|NCT01111474|FG000|Participant Flow|All Study Participants|In this split mouth study, teeth from the participants were randomly assigned according to quadrants, to either receive Cyanoacrilate (Superbonder) or Laser (LILT). Cyanoacrylate: 3 applications with a microbrush (48 hour interval). Laser: 3 Low intensity laser application (48 hour interval). The application of 1Joules/cm^2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (795nm)
11011422|NCT01111474|OG000|Outcome|Cyanoacrylate|3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth
11011423|NCT01111474|OG001|Outcome|Laser|3 Low intensity laser application (48 hour interval). The application of 1Joule/cm^2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (795nm)
11011424|NCT01111474|EG000|Reported Event|Cyanoacrylate|3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth
11011425|NCT01111474|EG001|Reported Event|Laser|3 Low intensity laser application (48 hour interval). The application of 1J/cm2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (660nm)
10886021|NCT00491764|BG004|Baseline|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
10886022|NCT00491764|BG005|Baseline|Placebo for 24 Weeks|Placebo for 24 weeks.
10886023|NCT00491764|BG006|Baseline|Total|Total of all reporting groups
10886024|NCT00491764|FG000|Participant Flow|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
10886025|NCT00491764|FG001|Participant Flow|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
10886026|NCT00491764|FG002|Participant Flow|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
10886027|NCT00491764|FG003|Participant Flow|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
10886028|NCT00491764|FG004|Participant Flow|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
10886029|NCT00491764|FG005|Participant Flow|Placebo for 24 Weeks|Placebo for 24 weeks.
10886030|NCT00491764|OG000|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
10886031|NCT00491764|OG001|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
10886032|NCT00491764|OG002|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
10886033|NCT00491764|OG003|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
10886034|NCT00491764|OG004|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
10886035|NCT00491764|OG005|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
10886036|NCT00491764|EG000|Reported Event|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks
10886037|NCT00491764|EG001|Reported Event|Posaconazole 200 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks
10886038|NCT00491764|EG002|Reported Event|Posaconazole 400 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks
10886039|NCT00491764|EG003|Reported Event|Posaconazole 400 mg QD for 12 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks
10886040|NCT00491764|EG004|Reported Event|Terbinafine 250 mg QD for 12 Weeks|Terbinafine 250 mg QD for 12 weeks
10886041|NCT00491764|EG005|Reported Event|Placebo for 24 Weeks|Placebo for 24 weeks
10886042|NCT00491829|BG000|Baseline|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
10886043|NCT00491829|BG001|Baseline|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
10886044|NCT00491829|BG002|Baseline|Placebo|"placebo qhs~placebo: placebo"
10886045|NCT00491829|BG003|Baseline|Total|Total of all reporting groups
10886046|NCT00491829|FG000|Participant Flow|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
10886047|NCT00491829|FG001|Participant Flow|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
10886048|NCT00491829|FG002|Participant Flow|Placebo|"placebo qhs~placebo: placebo"
10886049|NCT00491829|OG000|Outcome|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
10886050|NCT00491829|OG001|Outcome|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
10886051|NCT00491829|OG002|Outcome|Placebo|"placebo qhs~placebo: placebo"
10886052|NCT00491829|EG000|Reported Event|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
10886053|NCT00491829|EG001|Reported Event|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
10886054|NCT00491829|EG002|Reported Event|Placebo|"placebo qhs~placebo: placebo"
10886055|NCT00491894|BG000|Baseline|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
10886056|NCT00491894|FG000|Participant Flow|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
10886057|NCT00491894|OG000|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
10886058|NCT00491894|EG000|Reported Event|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
10886059|NCT00492024|BG000|Baseline|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
10886060|NCT00492024|BG001|Baseline|Placebo|Matching placebo for 5 days
10886061|NCT00492024|BG002|Baseline|Total|Total of all reporting groups
10886062|NCT00492024|FG000|Participant Flow|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
10886063|NCT00492024|FG001|Participant Flow|Placebo|Matching placebo for 5 days
10886064|NCT00492024|OG000|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
10886065|NCT00492024|OG001|Outcome|Placebo|Matching placebo for 5 days
10886066|NCT00492024|EG000|Reported Event|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
10886067|NCT00492024|EG001|Reported Event|Placebo|Matching placebo for 5 days
10886068|NCT00492063|BG000|Baseline|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
10886069|NCT00492063|BG001|Baseline|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
10886070|NCT00492063|BG002|Baseline|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
10886071|NCT00492063|BG003|Baseline|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
10886072|NCT00492063|BG004|Baseline|Total|Total of all reporting groups
10886073|NCT00492063|FG000|Participant Flow|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
10886074|NCT00492063|FG001|Participant Flow|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
10886075|NCT00492063|FG002|Participant Flow|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
10886076|NCT00492063|FG003|Participant Flow|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
10886077|NCT00492063|OG000|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
10886078|NCT00492063|OG001|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
10886079|NCT00492063|OG002|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
10886080|NCT00492063|OG003|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
10886081|NCT00492063|EG000|Reported Event|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
10886082|NCT00492063|EG001|Reported Event|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
10886083|NCT00492063|EG002|Reported Event|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
10886084|NCT00492063|EG003|Reported Event|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
10886085|NCT00492089|BG000|Baseline|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
10886086|NCT00492089|BG001|Baseline|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
10886087|NCT00492089|BG002|Baseline|Total|Total of all reporting groups
10886088|NCT00492089|FG000|Participant Flow|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks.
10886089|NCT00492089|FG001|Participant Flow|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A.
10886090|NCT00492089|OG000|Outcome|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
10886091|NCT00492089|OG001|Outcome|Crossover Arm B: Placebo Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
10886092|NCT00492089|EG000|Reported Event|Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
10886093|NCT00492089|EG001|Reported Event|Placebo|First Intervention Placebo IV (only) every 3 weeks for two courses
10886094|NCT00492115|BG000|Baseline|A: Continuous Positive Airway Pressure|Continuous Positive Airway Pressure (therapeutic CPAP) for 6 weeks
10886095|NCT00492115|BG001|Baseline|B. Sham CPAP|Sham (placebo) CPAP for 3 weeks followed by therapeutic CPAP for 3 weeks.
10886096|NCT00492115|BG002|Baseline|Total|Total of all reporting groups
10886097|NCT00492115|FG000|Participant Flow|A: Continuous Positive Airway Pressure (CPAP)|"Continuous positive airway pressure (CPAP)~Continuous positive airway pressure (CPAP): therapeutic CPAP for six weeks"
10886098|NCT00492115|FG001|Participant Flow|B: Placebo Continuous Positive Airway Pressure|"Placebo Continuous Positive airway pressure~Placebo CPAP: Ineffective CPAP 3 weeks placebo CPAP followed by 3 weeks of therapeutic CPAP"
10886099|NCT00492115|OG000|Outcome|A: Continuous Positive Airway Pressure (CPAP):|"CPAP~Continuous positive airway pressure (CPAP): therapeutic CPAP"
10886100|NCT00492115|OG001|Outcome|B: Placebo CPAP: Ineffective CPAP|"Placebo CPAP~Placebo CPAP: Ineffective CPAP"
10886101|NCT00492115|EG000|Reported Event|A: Continuous Positive Airway Pressure (CPAP): Therapeutic CPA|"CPAP~Continuous positive airway pressure (CPAP): therapeutic CPAP for 6 weeks"
10886102|NCT00492115|EG001|Reported Event|B: Placebo CPAP: Ineffective CPAP|"Placebo CPAP~Placebo CPAP: Ineffective CPAP for 3 weeks followed by therapeutic CPAP for 3 weeks"
10886103|NCT00492206|BG000|Baseline|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
10886104|NCT00492206|FG000|Participant Flow|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
10886105|NCT00492206|OG000|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
10886106|NCT00492206|OG000|Outcome|Received Concurrent Radiotherapy + Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
10886107|NCT00492206|OG000|Outcome|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
10886108|NCT00492206|EG000|Reported Event|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
10886109|NCT00492232|BG000|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
10886110|NCT00492232|BG001|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
10886111|NCT00492232|BG002|Baseline|Total|Total of all reporting groups
10886112|NCT00492232|FG000|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
10886113|NCT00492232|FG001|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
10886114|NCT00492232|OG000|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
10886115|NCT00492232|OG001|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
10886116|NCT00492232|EG000|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
10886117|NCT00492232|EG001|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
10886118|NCT00492284|BG000|Baseline|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
10886119|NCT00492284|BG001|Baseline|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
10886120|NCT00492284|BG002|Baseline|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
10886121|NCT00492284|BG003|Baseline|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
10886122|NCT00492284|BG004|Baseline|Total|Total of all reporting groups
10886123|NCT00492284|FG000|Participant Flow|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
10886124|NCT00492284|FG001|Participant Flow|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
10886125|NCT00492284|FG002|Participant Flow|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
10886126|NCT00492284|FG003|Participant Flow|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
10886127|NCT00492284|OG000|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
10886128|NCT00492284|OG001|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
11148005|NCT01860703|EG000|Reported Event|Treatment Arm A - Maximum Therapeutic Dose|"Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets, deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.~Deferiprone~deferiprone matching placebo tablets~moxifloxacin matching placebo tablet"
10886129|NCT00492284|OG002|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
10886130|NCT00492284|OG003|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
10886131|NCT00492284|EG000|Reported Event|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
10886132|NCT00492284|EG001|Reported Event|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
10886133|NCT00492284|EG002|Reported Event|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
10886134|NCT00492284|EG003|Reported Event|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
10886135|NCT00492297|BG000|Baseline|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
10886136|NCT00492297|FG000|Participant Flow|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid), the treatment continued until subjects had clear palliative benefit and were tolerating treatment well, or until progressive disease (PD) or death (if earlier) recorded up to 97 weeks. Subjects withdrawn from Sorafenib but with optional standard treatment entered Active Follow-up (AFU) period, which was 30(+4) days for subjects who had PD at the end of treatment; or until PD was documented for subjects who had complete response (CR) or partial response (PR) or stable disease (SD) at the end of treatment up to 97 weeks . Once subject progressed went into survival only follow-up which continued until death occurred up to 172 weeks.
10886137|NCT00492297|OG000|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
10886138|NCT00492297|EG000|Reported Event|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
10886139|NCT00492336|BG000|Baseline|Rasagiline|Treatment with Rasagiline
10886140|NCT00492336|BG001|Baseline|Inactive Pill|Treatment with Placebo
10886141|NCT00492336|BG002|Baseline|Total|Total of all reporting groups
10886142|NCT00492336|FG000|Participant Flow|Rasagiline|Treatment with Rasagiline
10886143|NCT00492336|FG001|Participant Flow|Inactive Pill|Treatment with Placebo
10886144|NCT00492336|OG000|Outcome|Rasagiline|Treatment with Rasagiline
10886145|NCT00492336|OG001|Outcome|Inactive Pill|Treatment with Placebo
10886146|NCT00492336|EG000|Reported Event|Rasagiline|Treatment with Rasagiline
10886147|NCT00492336|EG001|Reported Event|Inactive Pill|Treatment with Placebo
10886148|NCT00492401|BG000|Baseline|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
10886149|NCT00492401|FG000|Participant Flow|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
10886150|NCT00492401|OG000|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
11148006|NCT01860703|EG001|Reported Event|Treatment Arm B - Supratherapeutic Dose|"Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets, and one moxifloxacin matching placebo tablet.~Deferiprone~moxifloxacin matching placebo tablet"
10886151|NCT00492401|OG000|Outcome|Responders|Any patient that achieved a CR (Complete Response), or Incomplete CR was categorized as a responder.
10886152|NCT00492401|OG001|Outcome|Non Responder|Any patient that did not achieve a CR (Complete Response), or Incomplete CR was categorized as a non responder.
10886153|NCT00492401|EG000|Reported Event|Treatment (Chemotherapy)|"Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~decitabine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~high performance liquid chromatography: Correlative studies~microarray analysis: Correlative studies~RNA analysis: Correlative studies~mass spectrometry: Correlative studies~DNA methylation analysis: Correlative studies~matrix-assisted laser desorption/ionization time of flight mass spectrometry: Correlative studies"
10886154|NCT00492531|BG000|Baseline|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
10886155|NCT00492531|BG001|Baseline|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
10886156|NCT00492531|BG002|Baseline|Total|Total of all reporting groups
10886157|NCT00492531|FG000|Participant Flow|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
10886158|NCT00492531|FG001|Participant Flow|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
10886159|NCT00492531|OG000|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
10886160|NCT00492531|OG001|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
11011426|NCT01111526|BG000|Baseline|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
11011427|NCT01111526|FG000|Participant Flow|Phase I Participants Not Evaluable for MTD|Participants who began treatment before the formulation change.
11011428|NCT01111526|FG001|Participant Flow|Phase I Participants Evaluable for MTD|Participants treated after the formulation change.
11011429|NCT01111526|FG002|Participant Flow|Phase II Participants Treated at MTD|All participants enrolled during Phase II.
11011430|NCT01111526|OG000|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
11011431|NCT01111526|EG000|Reported Event|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
11011432|NCT01111539|BG000|Baseline|Phase B: Single-blind Prospective Treatment Phase|Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
11011433|NCT01111539|FG000|Participant Flow|Phase B: Single-blind Prospective Treatment Phase|Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
11011434|NCT01111539|FG001|Participant Flow|Phase B+: Single-blind Phase B Responders|Participants with response (≥50% reduction in depressive symptom severity in Hamilton Depression Rating Scale {HAM-D17} Total Score; or a HAM-D17 Total Score of <14 at Week 8 or a Clinical Global Impression of Improvement {CGI-I} Score of <3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B, for up to maximum of Week 14, in Phase B+.
11011435|NCT01111539|FG002|Participant Flow|Phase C: Aripiprazole/Escitalopram Combination|Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
11011436|NCT01111539|FG003|Participant Flow|Phase C: Escitalopram Monotherapy|Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
11011437|NCT01111539|FG004|Participant Flow|Phase C: Aripiprazole Monotherapy|Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be decreased at any visit based upon tolerability.
11011438|NCT01111539|OG000|Outcome|Phase C: Aripiprazole/Escitalopram Combination|Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
11011439|NCT01111539|OG001|Outcome|Phase C: Escitalopram Monotherapy|Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
11148007|NCT01860703|EG002|Reported Event|Treatment Arm C - Placebo Control|"Single dose of deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.~deferiprone matching placebo tablets~moxifloxacin matching placebo tablet"
11148008|NCT01860703|EG003|Reported Event|Treatment Arm D - Positive Control|"Single dose of deferiprone matching placebo tablets and one 400 mg moxifloxacin tablet.~Deferiprone~moxifloxacin"
11148009|NCT01860807|BG000|Baseline|Ibudilast|"Ibudilast 50 mg twice daily~Ibudilast"
11011440|NCT01111539|OG002|Outcome|Phase C: Aripiprazole Monotherapy|Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be decreased at any visit based upon tolerability.
11011441|NCT01111539|EG000|Reported Event|Phase B: Single-blind Prospective Treatment Phase|Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
11011442|NCT01111539|EG001|Reported Event|Phase B+: Single-blind Phase B Responders|Participants with response (≥50% reduction in depressive symptom severity in Hamilton Depression Rating Scale {HAM-D17} Total Score; or a HAM-D17 Total Score of <14 at Week 8 or a Clinical Global Impression of Improvement {CGI-I} Score of <3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B, for up to maximum of Week 14, in Phase B+.
11011443|NCT01111539|EG002|Reported Event|Phase C: Aripiprazole/Escitalopram Combination|Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
11011444|NCT01111539|EG003|Reported Event|Phase C: Escitalopram Monotherapy|Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
11011445|NCT01111539|EG004|Reported Event|Phase C: Aripiprazole Monotherapy|Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be decreased at any visit based upon tolerability.
11011446|NCT01111552|BG000|Baseline|Phase B: Single-blind Prospective Treatment Phase|Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the end of Week 1 based upon tolerability profile, plus one matching placebo capsule, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
11011447|NCT01111552|FG000|Participant Flow|Phase B: Single-blind Prospective Treatment Phase|Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the end of Week 1 based upon tolerability profile, plus one matching placebo capsule, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
11011448|NCT01111552|FG001|Participant Flow|Phase B+: Single-blind Phase B Responders|Participants with response at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B plus one matching placebo capsule, for an additional 6 weeks, in Phase B+.
11011449|NCT01111552|FG002|Participant Flow|Phase C: Escitalopram Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
11011450|NCT01111552|FG003|Participant Flow|Phase C: Aripiprazole Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily plus one matching placebo capsule for 6 weeks, in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any week, based upon tolerability.
11011451|NCT01111552|FG004|Participant Flow|Phase C: Aripiprazole/Escitalopram Combination Therapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally, once daily plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
11148010|NCT01860807|BG001|Baseline|Placebo|"matching placebo twice daily~Placebo"
11011452|NCT01111552|OG000|Outcome|Phase C: Escitalopram Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
11011453|NCT01111552|OG001|Outcome|Phase C: Aripiprazole Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily plus one matching placebo capsule for 6 weeks, in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any week, based upon tolerability.
11011454|NCT01111552|OG002|Outcome|Phase C: Aripiprazole/Escitalopram Combination Therapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally, once daily plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
11011455|NCT01111552|EG000|Reported Event|Phase B: Single-blind Prospective Treatment Phase|Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the end of Week 1 based upon tolerability profile, plus one matching placebo capsule, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
11011456|NCT01111552|EG001|Reported Event|Phase B+: Single-blind Phase B Responders|Participants with response at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B plus one matching placebo capsule, for an additional 6 weeks, in Phase B+.
11011457|NCT01111552|EG002|Reported Event|Phase C: Escitalopram Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
11011458|NCT01111552|EG003|Reported Event|Phase C: Aripiprazole Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily plus one matching placebo capsule for 6 weeks, in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any week, based upon tolerability.
11011459|NCT01111552|EG004|Reported Event|Phase C: Aripiprazole/Escitalopram Combination Therapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally, once daily plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
11011460|NCT01111604|BG000|Baseline|mFOLFOX-6|"mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011461|NCT01111604|BG001|Baseline|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~Ramucirumab: 8 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011462|NCT01111604|BG002|Baseline|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~Icrucumab: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011463|NCT01111604|BG003|Baseline|Total|Total of all reporting groups
11011464|NCT01111604|FG000|Participant Flow|mFOLFOX-6|"mFOLFOX-6: Oxaliplatin: 85 milligram/meter squared, intravenous (mg/m², IV) infusion every 2 weeks (Q2W)~Folinic acid (FA): 400 mg/m² IV infusion Q2W (or Levo-folinic acid [LFA]: 200 mg/m² Q2 weeks if FA is unavailable).~Fluorouracil (5FU): 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W"
10886161|NCT00492531|EG000|Reported Event|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
11011465|NCT01111604|FG001|Participant Flow|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~Ramucirumab: 8 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2 weeks if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W"
11011466|NCT01111604|FG002|Participant Flow|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~Icrucumab: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011467|NCT01111604|OG000|Outcome|mFOLFOX-6|"mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011468|NCT01111604|OG001|Outcome|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~Ramucirumab: 8 mg/kg IV infusion Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011469|NCT01111604|OG002|Outcome|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~Icrucumab: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W~FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011470|NCT01111604|OG000|Outcome|mFOLFOX-6|"mFOLFOX-6~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011471|NCT01111604|OG001|Outcome|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~Ramucirumab: 8 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011472|NCT01111604|OG002|Outcome|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~Icrucumab: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion Q2W"
11011473|NCT01111604|OG000|Outcome|mFOLFOX-6|"mFOLFOX-6~mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011474|NCT01111604|OG001|Outcome|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab Ramucirumab: 8 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011475|NCT01111604|OG002|Outcome|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~Icrucumab: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011476|NCT01111604|OG000|Outcome|mFOLFOX-6|"mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W(or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W"
11011477|NCT01111604|OG001|Outcome|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~IMC-1121B: 8 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011478|NCT01111604|OG002|Outcome|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~IMC-18F1: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011479|NCT01111604|OG000|Outcome|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~IMC-1121B: 8 mg/kg IV Q2W mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011480|NCT01111604|OG001|Outcome|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~IMC-18F1: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011481|NCT01111604|OG000|Outcome|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~Ramucirumab: 8 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011482|NCT01111604|OG001|Outcome|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~Icrucumab: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
11011483|NCT01111604|OG000|Outcome|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~Ramucirumab: 8 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks"
11011484|NCT01111604|OG000|Outcome|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~Icrucumab: 15 mg/kg IV Q2W~mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion Q2W"
11011485|NCT01111604|OG000|Outcome|mFOLFOX-6|"mFOLFOX-6~mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks"
11011486|NCT01111604|OG001|Outcome|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~IMC-1121B: 8 mg/kg I.V. infusion, administered every 2 weeks~mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks"
11011487|NCT01111604|OG002|Outcome|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab Icrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks"
11011488|NCT01111604|EG000|Reported Event|mFOLFOX-6|"mFOLFOX-6~mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks"
11011489|NCT01111604|EG001|Reported Event|mFOLFOX-6 + Ramucirumab|"mFOLFOX-6 + Ramucirumab~Ramucirumab : 8 mg/kg I.V. infusion, administered every 2 weeks~mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks"
11011490|NCT01111604|EG002|Reported Event|mFOLFOX-6 + Icrucumab|"mFOLFOX-6 + Icrucumab~Icrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks~mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks~FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).~5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks"
11011491|NCT01111825|BG000|Baseline|Phase 1|Phase I, HER - Amplified (HER2-Positive) cohort
11011492|NCT01111825|BG001|Baseline|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
11011493|NCT01111825|BG002|Baseline|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
11011494|NCT01111825|BG003|Baseline|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
11011495|NCT01111825|BG004|Baseline|Total|Total of all reporting groups
11011496|NCT01111825|FG000|Participant Flow|Phase 1|Phase I, HER - Amplified (HER2-Positive) cohort
11011497|NCT01111825|FG001|Participant Flow|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
11011498|NCT01111825|FG002|Participant Flow|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
11011499|NCT01111825|FG003|Participant Flow|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
11011500|NCT01111825|OG000|Outcome|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
11011501|NCT01111825|OG001|Outcome|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
11011502|NCT01111825|OG002|Outcome|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
11011503|NCT01111825|OG000|Outcome|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
11011504|NCT01111825|EG000|Reported Event|Phase 1|Phase I, HER - Amplified (HER2-Positive) cohort
11011505|NCT01111825|EG001|Reported Event|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
11011506|NCT01111825|EG002|Reported Event|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
11148011|NCT01860807|BG002|Baseline|Total|Total of all reporting groups
11011507|NCT01111825|EG003|Reported Event|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
11011508|NCT01111838|BG000|Baseline|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
11011509|NCT01111838|FG000|Participant Flow|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
11011510|NCT01111838|OG000|Outcome|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
11011511|NCT01111838|EG000|Reported Event|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
11011512|NCT01111851|BG000|Baseline|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
11011513|NCT01111851|BG001|Baseline|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
11011514|NCT01111851|BG002|Baseline|Total|Total of all reporting groups
11011515|NCT01111851|FG000|Participant Flow|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
11011516|NCT01111851|FG001|Participant Flow|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
11011517|NCT01111851|OG000|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
11011518|NCT01111851|OG001|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
11011519|NCT01111851|EG000|Reported Event|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
11011520|NCT01111851|EG001|Reported Event|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
11011521|NCT01112059|BG000|Baseline|Placebo|placebo: placebo
11011522|NCT01112059|BG001|Baseline|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
11011523|NCT01112059|BG002|Baseline|Total|Total of all reporting groups
11011524|NCT01112059|FG000|Participant Flow|Placebo|placebo: placebo
11011525|NCT01112059|FG001|Participant Flow|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
11011526|NCT01112059|OG000|Outcome|Placebo|"placebo: placebo~No SAEs noted in this group, 4 total AEs recorded."
11011527|NCT01112059|OG001|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
11011528|NCT01112059|OG000|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
11011529|NCT01112059|OG001|Outcome|Placebo|placebo for 8 days
11011530|NCT01112059|OG000|Outcome|Placebo|placebo for 8 days
11011531|NCT01112059|EG000|Reported Event|Placebo|placebo: placebo
11011532|NCT01112059|EG001|Reported Event|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
11011533|NCT01112228|BG000|Baseline|Obese Patients|"Obese patients for Bariatric surgery~Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding"
11011534|NCT01112228|FG000|Participant Flow|Obese Patients|"Obese patients for Bariatric surgery~Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding"
11011535|NCT01112228|OG000|Outcome|Obese Patients|"Obese patients for Bariatric surgery~Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding"
11011536|NCT01112228|OG000|Outcome|Patients With Diabetes and Obesity|Patients with diabetes pre-surgery who had improvement in any one of the clinical domains as measure in the King's Obesity Staging Score
11011537|NCT01112228|OG001|Outcome|Patients With Sleep Apnea|Patients with Sleep Apnea pre-surgery who had improvement in any one of the clinical domains as measured in the King's Obesity Staging Score
11011538|NCT01112228|EG000|Reported Event|Obese Patients|"Obese patients for Bariatric surgery~Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding"
11011539|NCT01112241|BG000|Baseline|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
11011540|NCT01112241|FG000|Participant Flow|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
11011541|NCT01112241|OG000|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
11011542|NCT01112241|EG000|Reported Event|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
11011543|NCT01112267|BG000|Baseline|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
11011544|NCT01112267|BG001|Baseline|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
11011545|NCT01112267|BG002|Baseline|Total|Total of all reporting groups
11011546|NCT01112267|FG000|Participant Flow|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
11011547|NCT01112267|FG001|Participant Flow|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
11011548|NCT01112267|OG000|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
11011549|NCT01112267|OG001|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
11011550|NCT01112267|EG000|Reported Event|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
11011551|NCT01112267|EG001|Reported Event|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
11011552|NCT01112293|BG000|Baseline|Investigational Drug infusion-for Safety and Effectiveness|"Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment~GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively."
11011553|NCT01112293|FG000|Participant Flow|Investigational Drug infusion-for Safety and Effectiveness|"Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment~GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively."
11011554|NCT01112293|OG000|Outcome|Investigational Drug infusion-for Safety and Effectiveness|"Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment~GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively."
11011555|NCT01112293|EG000|Reported Event|Investigational Drug infusion-for Safety and Effectiveness|"Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment.~GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively."
11011556|NCT01112358|BG000|Baseline|r-FSH + r-hLH|Lutropin alfa (recombinant human luteinizing hormone [r-hLH]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
11011557|NCT01112358|BG001|Baseline|r-FSH|Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
11011558|NCT01112358|BG002|Baseline|Total|Total of all reporting groups
11011559|NCT01112358|FG000|Participant Flow|r-FSH + r-hLH|Lutropin alfa (recombinant human luteinizing hormone [r-hLH]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
11011560|NCT01112358|FG001|Participant Flow|r-FSH|Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
11011561|NCT01112358|OG000|Outcome|r-FSH + r-hLH|Lutropin alfa (recombinant human luteinizing hormone [r-hLH]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
11011562|NCT01112358|OG001|Outcome|r-FSH|Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
11011563|NCT01112358|EG000|Reported Event|r-FSH + r-hLH|Lutropin alfa (recombinant human luteinizing hormone [r-hLH]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
11011564|NCT01112358|EG001|Reported Event|r-FSH|Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
11011565|NCT01112514|BG000|Baseline|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
11011566|NCT01112514|FG000|Participant Flow|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
11011567|NCT01112514|OG000|Outcome|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
11011568|NCT01112514|EG000|Reported Event|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
11011569|NCT01112579|BG000|Baseline|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
11011570|NCT01112579|BG001|Baseline|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
11011571|NCT01112579|BG002|Baseline|Total|Total of all reporting groups
11011572|NCT01112579|FG000|Participant Flow|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
11011573|NCT01112579|FG001|Participant Flow|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
11011574|NCT01112579|OG000|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
11011575|NCT01112579|OG001|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
11011576|NCT01112579|EG000|Reported Event|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
11011577|NCT01112579|EG001|Reported Event|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
11011578|NCT01112670|BG000|Baseline|Overall Study Population|All participants who participated in at least one period of the study (n=33)
11011579|NCT01112670|FG000|Participant Flow|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 8 participants started. 7 participants completed.
11011580|NCT01112670|FG001|Participant Flow|ABCB1 Group 1*|ABCB1 CGC/CGC genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 3 participants started. 3 participants completed.
11011581|NCT01112670|FG002|Participant Flow|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 7 participants started. 6 participants completed.
11011582|NCT01112670|FG003|Participant Flow|ABCB1 Group 2*|ABCB1 CGC/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagiptin. 4 participants started. 4 participants completed.
11011583|NCT01112670|FG004|Participant Flow|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 6 participants started. 5 participants completed.
11011584|NCT01112670|FG005|Participant Flow|ABCB1 Group 3*|ABCB1 TTT/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 5 participants started. 5 participants completed.
11011585|NCT01112670|OG000|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
11011586|NCT01112670|OG001|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
11011587|NCT01112670|OG002|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
11011588|NCT01112670|OG001|Outcome|ABCB1 Group 2|ABCB1 CGC/CGC genetic make-up
11011589|NCT01112670|EG000|Reported Event|Overall Study Population|All participants who started the study (n=33)
11011590|NCT01112683|BG000|Baseline|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
11011591|NCT01112683|BG001|Baseline|Placebo|These are identically-looking pills to the ones in the Memantine Arm
11011592|NCT01112683|BG002|Baseline|Total|Total of all reporting groups
11148012|NCT01860807|FG000|Participant Flow|Ibudilast|"Ibudilast 50 mg twice daily~Ibudilast"
11011593|NCT01112683|FG000|Participant Flow|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
11011594|NCT01112683|FG001|Participant Flow|Placebo|These are identically-looking pills to the ones in the Memantine Arm
11011595|NCT01112683|OG000|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
11011596|NCT01112683|OG001|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
11011597|NCT01112683|EG000|Reported Event|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
11011598|NCT01112683|EG001|Reported Event|Placebo|These are identically-looking pills to the ones in the Memantine Arm
11011599|NCT01112696|BG000|Baseline|Group 1|Sensor Users (All Subjects)
11011600|NCT01112696|FG000|Participant Flow|Group 1|Sensor Users (All Subjects)
11011601|NCT01112696|OG000|Outcome|All Completed Subjects|All subjects that completed the frequent blood sampling procedure
11011602|NCT01112696|OG000|Outcome|Sensor|"All subjects that wear sensors (all subjects)~Sensor wear: All subjects to wear sensors"
11011603|NCT01112696|EG000|Reported Event|Group 1|Sensor Users (All Subjects)
11011604|NCT01112735|BG000|Baseline|ARTISS|"ARTISS will be used as an adjuvant to standard of care.~ARTISS, also known as FS VH S/D 4 s-apr is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma.~The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period."
11011605|NCT01112735|BG001|Baseline|Standard of Care|Standard of care
11011606|NCT01112735|BG002|Baseline|Total|Total of all reporting groups
11011607|NCT01112735|FG000|Participant Flow|ARTISS|"ARTISS will be used as an adjuvant to standard of care.~ARTISS, also known as FS VH S/D 4 s-apr is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma.~The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period."
11011608|NCT01112735|FG001|Participant Flow|Standard of Care|Standard of care
11011609|NCT01112735|OG000|Outcome|ARTISS|"ARTISS will be used as an adjuvant to standard of care.~ARTISS, also known as FS VH S/D 4 s-apr is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma.~The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period."
11011610|NCT01112735|OG001|Outcome|Standard of Care|Standard of care
11011611|NCT01112735|EG000|Reported Event|ARTISS|"ARTISS will be used as an adjuvant to standard of care.~FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma): Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed."
11011612|NCT01112735|EG001|Reported Event|Standard of Care|"Standard of care~Standard of care: Standard of care"
11011613|NCT01112865|BG000|Baseline|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
11011614|NCT01112865|FG000|Participant Flow|Mark VII Pen Then Genotropin® Pen|Participant (not caregiver) used Mark VII pen (subcutaneous injections daily for 2 months) then the current Genotropin® pen (subcutaneous injections daily for 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
11011615|NCT01112865|FG001|Participant Flow|Genotropin® Pen Then Mark VII Pen|Participant (not caregiver) used current Genotropin® pen (subcutaneous injections daily for 2 months) then the Mark VII pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
11011616|NCT01112865|OG000|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
11011617|NCT01112865|OG000|Outcome|Mark VII Pen|Participants who used the Mark VII pen (subcutaneous injections daily for 2 months) any time during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
11011618|NCT01112865|OG001|Outcome|Genotropin® Pen|Participants who used the current Genotropin® pen (subcutaneous injections daily for 2 months) anytime during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
11011619|NCT01112865|EG000|Reported Event|Safety Population|All randomized participants who used a study pen (Genotropin® pen or the new Mark VII injection pen) at least once to administer Genotropin.
11011620|NCT01112917|BG000|Baseline|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
11011621|NCT01112917|FG000|Participant Flow|VenaTech Convertible Filter - Converted Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
11011622|NCT01112917|FG001|Participant Flow|VenaTech Convertible Filter - Permanent Filtration|VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
11011623|NCT01112917|OG000|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
11011624|NCT01112917|EG000|Reported Event|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
11011625|NCT01112982|BG000|Baseline|MRI of Index Joint|"All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their index joint determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the index joint will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.~Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).~Plain Radiographs: Plain radiographs of index joint will be obtained and reviewed by two independent readers (radiologists)"
11011626|NCT01112982|FG000|Participant Flow|MRI of Index Joint|"All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their index joint determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the index joint will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.~Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).~Plain Radiographs: Plain radiographs of index joint will be obtained and reviewed by two independent readers (radiologists)"
11011627|NCT01112982|OG000|Outcome|MRI of Index Joint|"All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their index joint determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the index joint will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.~Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).~Plain Radiographs: Plain radiographs of index joint will be obtained and reviewed by two independent readers (radiologists)"
11011628|NCT01112982|OG000|Outcome|Febuxostat Sub-Study|The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
11011629|NCT01112982|OG000|Outcome|MRI of Index Joint|"To analyze synovial pannus in the Magnetic Resonance Imaging (with and without gadolinium) of the index joint on Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug.~Magnetic Resonance Imaging: An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images)."
11011630|NCT01112982|OG001|Outcome|Febuxostat Sub-Study|The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
11011631|NCT01112982|EG000|Reported Event|MRI of Index Joint|"All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their index joint determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the index joint will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.~Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).~Plain Radiographs: Plain radiographs of index joint will be obtained and reviewed by two independent readers (radiologists)"
11011632|NCT01113008|BG000|Baseline|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning: Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
11011633|NCT01113008|BG001|Baseline|Control Group|Control group: In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
11011634|NCT01113008|BG002|Baseline|Total|Total of all reporting groups
11011635|NCT01113008|FG000|Participant Flow|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
11011636|NCT01113008|FG001|Participant Flow|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
11011637|NCT01113008|OG000|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
11011638|NCT01113008|OG001|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
11011639|NCT01113008|EG000|Reported Event|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
11011640|NCT01113008|EG001|Reported Event|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
11011641|NCT01113385|BG000|Baseline|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
11011642|NCT01113385|FG000|Participant Flow|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
11011643|NCT01113385|OG000|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
11011644|NCT01113385|EG000|Reported Event|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
11066052|NCT01390818|OG007|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066053|NCT01390818|OG008|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066054|NCT01390818|OG010|Outcome|MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066055|NCT01390818|OG011|Outcome|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066056|NCT01390818|OG012|Outcome|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066057|NCT01390818|OG013|Outcome|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066058|NCT01390818|OG014|Outcome|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066059|NCT01390818|OG000|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066060|NCT01390818|OG001|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066061|NCT01390818|OG002|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066062|NCT01390818|OG003|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066063|NCT01390818|OG004|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11148013|NCT01860807|FG001|Participant Flow|Placebo|"matching placebo twice daily~Placebo"
11148014|NCT01860807|OG000|Outcome|Ibudilast|"Ibudilast 50 mg twice daily~Ibudilast"
11011645|NCT01113398|BG000|Baseline|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
11011646|NCT01113398|FG000|Participant Flow|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
11011647|NCT01113398|OG000|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
11011648|NCT01113398|EG000|Reported Event|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
11011649|NCT01113463|BG000|Baseline|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
11011650|NCT01113463|FG000|Participant Flow|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
11011651|NCT01113463|OG000|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
11011652|NCT01113463|EG000|Reported Event|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
11011653|NCT01113502|BG000|Baseline|Phase I Dose Level I|50mg Eltrombopag taken daily by mouth
11011654|NCT01113502|BG001|Baseline|Phase I Dose Level II|100mg Eltrombopag taken daily by mouth
11011655|NCT01113502|BG002|Baseline|Phase I Dose Level III|200mg Eltrombopag taken daily by mouth
11011656|NCT01113502|BG003|Baseline|Phase I Dose Level IV|300mg Eltrombopag taken daily by mouth
11011657|NCT01113502|BG004|Baseline|Phase II|2 weeks of 200mg Eltrombopag taken daily by mouth then 300mg Eltrombopag taken daily by mouth
11011658|NCT01113502|BG005|Baseline|Total|Total of all reporting groups
11011659|NCT01113502|FG000|Participant Flow|Phase I Dose Level I|50 mg Eltrombopag taken daily by mouth
11011660|NCT01113502|FG001|Participant Flow|Phase I Dose Level II|100 mg Eltrombopag taken daily by mouth
11011661|NCT01113502|FG002|Participant Flow|Phase I Dose Level III|200 mg Eltrombopag taken daily by mouth
11011662|NCT01113502|FG003|Participant Flow|Phase I Dose Level IV|300 mg Eltrombopag taken daily by mouth
11011663|NCT01113502|FG004|Participant Flow|Phase II Dose Level|2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
11011664|NCT01113502|OG000|Outcome|Phase I Dose Level I|50 mg Eltrombopag taken daily by mouth
11011665|NCT01113502|OG001|Outcome|Phase I Dose Level II|100 mg Eltrombopag taken daily by mouth
11011666|NCT01113502|OG002|Outcome|Phase I Dose Level III|200 mg Eltrombopag taken daily by mouth
11011667|NCT01113502|OG003|Outcome|Phase I Dose Level IV|300 mg Eltrombopag taken daily by mouth
11011668|NCT01113502|OG000|Outcome|Phase II Dose Level|2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
11011669|NCT01113502|OG004|Outcome|Phase II Dose Level|2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
11011670|NCT01113502|EG000|Reported Event|Phase I Dose Level I|50 mg Eltrombopag taken daily by mouth
11011671|NCT01113502|EG001|Reported Event|Phase I Dose Level II|100 mg Eltrombopag taken daily by mouth
11011672|NCT01113502|EG002|Reported Event|Phase I Dose Level III|200 mg Eltrombopag taken daily by mouth
11148015|NCT01860807|OG001|Outcome|Placebo|"matching placebo twice daily~Placebo"
11148016|NCT01860807|EG000|Reported Event|Ibudilast|"Ibudilast 50 mg twice daily~Ibudilast"
11148017|NCT01860807|EG001|Reported Event|Placebo|"matching placebo twice daily~Placebo"
11011673|NCT01113502|EG003|Reported Event|Phase I Dose Level IV|300 mg Eltrombopag taken daily by mouth
11011674|NCT01113502|EG004|Reported Event|Phase II Dose Level|2 weeks of 200 mg Eltrombopag taken daily by mouth, then 300 mg Eltrombopag taken daily by mouth
11011675|NCT01113541|BG000|Baseline|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
11011676|NCT01113541|FG000|Participant Flow|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
11011677|NCT01113541|OG000|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
11011678|NCT01113541|EG000|Reported Event|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
11148018|NCT01860846|BG000|Baseline|Participants With Moderate to Severe Crohn's Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
11011679|NCT01113580|BG000|Baseline|Adults|Healthy volunteers aged 18 to 59 years
11011680|NCT01113580|BG001|Baseline|Older Adults|Healthy volunteers aged 60 years or older
11011681|NCT01113580|BG002|Baseline|Total|Total of all reporting groups
11011682|NCT01113580|FG000|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
11011683|NCT01113580|FG001|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
11011684|NCT01113580|OG000|Outcome|Adults|Healthy volunteers aged 18 to 59 years
11011685|NCT01113580|OG001|Outcome|Older Adults|Healthy volunteers aged 60 years or older
11011686|NCT01113580|EG000|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
11011687|NCT01113580|EG001|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
11011688|NCT01113632|BG000|Baseline|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
11011689|NCT01113632|BG001|Baseline|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
11011690|NCT01113632|BG002|Baseline|Total|Total of all reporting groups
11011691|NCT01113632|FG000|Participant Flow|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
11011692|NCT01113632|FG001|Participant Flow|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
11011693|NCT01113632|OG000|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
11011694|NCT01113632|OG001|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
11148019|NCT01860846|FG000|Participant Flow|Participants With Moderate to Severe Crohn's Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
11011695|NCT01113632|EG000|Reported Event|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
11011696|NCT01113632|EG001|Reported Event|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
11011697|NCT01113710|BG000|Baseline|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
11011698|NCT01113710|FG000|Participant Flow|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
11011699|NCT01113710|OG000|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
11011700|NCT01113710|EG000|Reported Event|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
11011701|NCT01113723|BG000|Baseline|CMAC Device|"CMAC~CMAC: CMAC Device"
11011702|NCT01113723|BG001|Baseline|Fiberoptic Bronchoscope|"Fiberoptic bronchoscope~Fiberoptic bronchoscope: Fiberoptic bronchoscope device"
11011703|NCT01113723|BG002|Baseline|Total|Total of all reporting groups
11011704|NCT01113723|FG000|Participant Flow|CMAC Device|"CMAC~CMAC: CMAC Device"
11011705|NCT01113723|FG001|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
11011706|NCT01113723|OG000|Outcome|CMAC Device|CMAC: CMAC Device
11011707|NCT01113723|OG001|Outcome|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
11011708|NCT01113723|OG000|Outcome|CMAC Device|"CMAC~CMAC: CMAC Device"
11011709|NCT01113723|OG001|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
11011710|NCT01113723|EG000|Reported Event|CMAC Device|"CMAC~CMAC: CMAC Device"
11011711|NCT01113723|EG001|Reported Event|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
11011712|NCT01113749|BG000|Baseline|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
11011713|NCT01113749|BG001|Baseline|Control|
11011714|NCT01113749|BG002|Baseline|Total|Total of all reporting groups
11011715|NCT01113749|FG000|Participant Flow|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
11011716|NCT01113749|FG001|Participant Flow|Control|
11011717|NCT01113749|OG000|Outcome|Decision Support Intervention|Decision aid
11011718|NCT01113749|OG001|Outcome|Control|Usual care
11011719|NCT01113749|EG000|Reported Event|Decisions Support Intervention|
11011720|NCT01113749|EG001|Reported Event|Control|
11011721|NCT01113801|BG000|Baseline|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
11011722|NCT01113801|BG001|Baseline|2 mg LY2382770|2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
11011723|NCT01113801|BG002|Baseline|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
11011724|NCT01113801|BG003|Baseline|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
11011725|NCT01113801|BG004|Baseline|Total|Total of all reporting groups
11148020|NCT01860846|OG000|Outcome|Participants With Moderate to Severe Crohn's Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
11011726|NCT01113801|FG000|Participant Flow|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
11011727|NCT01113801|FG001|Participant Flow|2 mg LY2382770|2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
11011728|NCT01113801|FG002|Participant Flow|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
11011729|NCT01113801|FG003|Participant Flow|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
11011730|NCT01113801|OG000|Outcome|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
11011731|NCT01113801|OG001|Outcome|2 mg LY2382770|2 mg LY2382770 given (SC) injection monthly for 12 months
11011732|NCT01113801|OG002|Outcome|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
11011733|NCT01113801|OG003|Outcome|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
11011734|NCT01113801|EG000|Reported Event|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
11011735|NCT01113801|EG001|Reported Event|2 mg LY2382770|2 mg LY2382770 given (SC) injection monthly for 12 months
11011736|NCT01113801|EG002|Reported Event|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
11011737|NCT01113801|EG003|Reported Event|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
11011738|NCT01113879|BG000|Baseline|Aphasia Therapy With an Exercise Adjuvant|"Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.~Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate."
11011739|NCT01113879|BG001|Baseline|Aphasia Therapy With a Stretching Adjuvant|"Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.~Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks."
11011740|NCT01113879|BG002|Baseline|Total|Total of all reporting groups
11011741|NCT01113879|FG000|Participant Flow|Aphasia Therapy Alone, Then With Exercise|"Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.~Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.~Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus an aerobic exercise or stretching adjuvant."
11011742|NCT01113879|FG001|Participant Flow|Aphasia Therapy Alone, Then With Stretching|"Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.~Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks."
11011743|NCT01113879|OG000|Outcome|Aphasia Therapy With an Exercise Adjuvant|Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
11011744|NCT01113879|OG001|Outcome|Aphasia Therapy With a Stretching Adjuvant|Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
11011745|NCT01113879|OG000|Outcome|Aphasia Therapy With an Exercise Adjuvant|"Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.~Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate."
11011746|NCT01113879|OG001|Outcome|Aphasia Therapy With a Stretching Adjuvant|"Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.~Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks."
11011747|NCT01113879|EG000|Reported Event|Aphasia Therapy With an Exercise Adjuvant|"Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.~Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate."
11148021|NCT01860846|EG000|Reported Event|Participants With Moderate to Severe Crohn's Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
11011748|NCT01113879|EG001|Reported Event|Aphasia Therapy With a Stretching Adjuvant|"Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.~Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks."
11011749|NCT01113892|BG000|Baseline|EXXCEL Soft|Patients who were enrolled and treated with the EXXCEL Soft vascular graft.
11011750|NCT01113892|BG001|Baseline|FUSION Bioline|Patients who were enrolled and treated with the FUSION Bioline vascular graft.
11011751|NCT01113892|BG002|Baseline|Total|Total of all reporting groups
11011752|NCT01113892|FG000|Participant Flow|EXXCEL Soft|Patients who were enrolled and treated with the EXXCEL Soft vascular graft.
11011753|NCT01113892|FG001|Participant Flow|FUSION Bioline|Patients who were enrolled and treated with the FUSION Bioline vascular graft.
11011754|NCT01113892|OG000|Outcome|EXXCEL Soft|Patients who were enrolled and treated with the EXXCEL Soft vascular graft.
11011755|NCT01113892|OG001|Outcome|FUSION Bioline|Patients who were enrolled and treated with the FUSION Bioline vascular graft.
11011756|NCT01113892|EG000|Reported Event|EXXCEL Soft|Patients who were enrolled and treated with the EXXCEL Soft vascular graft. The safety population was defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received.
11011757|NCT01113892|EG001|Reported Event|FUSION Bioline|Patients who were enrolled and treated with the FUSION Bioline vascular graft. The safety population was defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received. Note that one patient was randomized to the Fusion Bioline group but received the FUSION graft in error.
11011758|NCT01113931|BG000|Baseline|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
11011759|NCT01113931|BG001|Baseline|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
11011760|NCT01113931|BG002|Baseline|Total|Total of all reporting groups
11011761|NCT01113931|FG000|Participant Flow|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
11011762|NCT01113931|FG001|Participant Flow|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
11011763|NCT01113931|OG000|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
11011764|NCT01113931|OG001|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
11011765|NCT01113931|EG000|Reported Event|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
11011766|NCT01113931|EG001|Reported Event|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
11011767|NCT01113983|BG000|Baseline|TAVI - TF Approach|"Transcatheter aortic valve implantation and transfemoral approach~Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach"
11011768|NCT01113983|BG001|Baseline|TAVI-TA Approach|"Transcatheter aortic valve implantation - Transapical approach~Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach"
11011769|NCT01113983|BG002|Baseline|Total|Total of all reporting groups
11011770|NCT01113983|FG000|Participant Flow|TAVI - TF Approach|"Transcatheter aortic valve implantation and transfemoral approach~Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical and transfemoral approach"
11011771|NCT01113983|FG001|Participant Flow|TAVI-TA Approach|Transcatheter aortic valve implantation - Transapical approach
11011772|NCT01113983|OG000|Outcome|TAVI - TF Approach|"Transcatheter aortic valve implantation and transfemoral approach~Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach"
11011773|NCT01113983|OG001|Outcome|TAVI-TA Approach|"Transcatheter aortic valve implantation - Transapical approach~Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach"
11011774|NCT01113983|EG000|Reported Event|TAVI - TF Approach|"Transcatheter aortic valve implantation and transfemoral approach~Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach"
11011775|NCT01113983|EG001|Reported Event|TAVI-TA Approach|"Transcatheter aortic valve implantation - Transapical approach~Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach"
11011776|NCT01114334|BG000|Baseline|Motivational Interviewing With Guideline-Based Management|"Intervention - MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and MI Spirit, as well as skill-building practice. At the providers' request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service~To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient's change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve."
11011777|NCT01114334|BG001|Baseline|Standard Management of Depression|"All providers randomized to either intervention or to control received a 1-hour slideshow and the American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression."
11011778|NCT01114334|BG002|Baseline|Total|Total of all reporting groups
11011779|NCT01114334|FG000|Participant Flow|Motivational Interviewing With Guideline-Based Management|"Intervention - MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and MI Spirit, as well as skill-building practice. At the providers' request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service~To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient's change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve."
11011780|NCT01114334|FG001|Participant Flow|Standard Management of Depression|"All providers randomized to either intervention or to control received a 1-hour slideshow and the American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression."
11011781|NCT01114334|OG000|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
11011782|NCT01114334|OG001|Outcome|Motivational Interview With GBMM|"Motivational Interviews combined with guideline-based medical management for depression~Guideline-Based Medical Management: We used the Colorado Clinical Guidelines Collaborative treatment guideline for Major Depression. It recommends treatment options e.g. specialty mental health counseling, antidepressant treatment, physical activity, depending upon presenting symptoms severity and other factors. The assessor notifies the clinician at the baseline visit about the patient's PHQ-9 depressive symptom severity score.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or"
11011783|NCT01114334|OG001|Outcome|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression~Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
11011784|NCT01114334|EG000|Reported Event|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
11011785|NCT01114334|EG001|Reported Event|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression~Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
11011786|NCT01114360|BG000|Baseline|All Participants|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
11011787|NCT01114360|FG000|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of placebo for 4 weeks first, followed by 8 mg of time-released melatonin for 4 weeks.
11011788|NCT01114360|FG001|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8 mg of time released melatonin at bed time for 4 weeks, followed by 8 mg of placebo at bedtime for an additional 4 weeks.
11011789|NCT01114360|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
11011790|NCT01114360|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
11011791|NCT01114360|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after exposure to 4 weeks of placebo).
11011792|NCT01114360|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks either before or after 4 weeks of exposure to 8mg daily dose of time release melatonin).
11011793|NCT01114360|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure placebo).
11011794|NCT01114360|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
11011795|NCT01114360|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks ((either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
11011796|NCT01114360|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8mg time release melatonin).
11011797|NCT01114360|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of placebo) in a crossover design.
11011798|NCT01114360|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after exposure to 8mg time release melatonin for 4 weeks).
11011799|NCT01114360|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks followed by 4 weeks of placebo.
11011800|NCT01114360|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks followed by 8mg time release melatonin for 4 weeks.
11011801|NCT01114360|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
11011802|NCT01114360|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between
11011803|NCT01114360|OG000|Outcome|Melatonin|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of treatment with placebo).~Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
11011804|NCT01114360|OG001|Outcome|Placebo|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of treatment with melatonin).~Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
11011805|NCT01114360|EG000|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
11011806|NCT01114360|EG001|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
11011807|NCT01114373|BG000|Baseline|All Subjects|African American subjects with mild to moderate essential hypertension received melatonin or placebo PO for the first 4 weeks then were switched to receive either placebo or melatonin PO therapy for an additional 4 weeks without any wash out period in between.
11011808|NCT01114373|FG000|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg of placebo at bed time for 4 weeks followed by 24 mg time release melatonin at bed time for 4 weeks.
11011809|NCT01114373|FG001|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg daily of time-released melatonin at bed time for 4 weeks, followed by 24 mg of placebo at bed time for 4 week.
11011810|NCT01114373|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
11011811|NCT01114373|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
11011812|NCT01114373|OG000|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
11011813|NCT01114373|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
11011814|NCT01114373|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
11011815|NCT01114373|OG001|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks(either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
11011816|NCT01114373|EG000|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
11011817|NCT01114373|EG001|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
11011818|NCT01114438|BG000|Baseline|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
11011819|NCT01114438|FG000|Participant Flow|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
11011820|NCT01114438|OG000|Outcome|EndoBarrier Liner Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
11011821|NCT01114438|OG000|Outcome|Decrease in Glucose-Lowering Meds|Subjects implanted with device for 12 Months with an Decrease in medication at the time of device removal compared to Baseline medication levels
11011822|NCT01114438|OG001|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjects implanted with device for 12 Months with an Increase in medication at the time of device removal compared to Baseline medication levels
11011823|NCT01114438|OG002|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects implanted with device for 12 Months with no change in medication at the time of device removal compared to Baseline medication levels
11011824|NCT01114438|OG000|Outcome|Device at Month 12 (Explant)|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner was implanted in participants for 12 months and then removed
11011825|NCT01114438|OG001|Outcome|Device at 6 Months Post-explant|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner was implanted in participants for 12 months and then removed.
11011826|NCT01114438|EG000|Reported Event|Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
11011827|NCT01114503|BG000|Baseline|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1-8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
11011828|NCT01114503|FG000|Participant Flow|Otelixizumab Cohort A1|Eligible participants received a total intravenous (IV) dose of otelixizumab 3.1 milligram (mg) for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 hours (h). The rate of infusion was 0.05 milligram per hour (mg/h) on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1-8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
11011829|NCT01114503|OG000|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1-8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
11011830|NCT01114503|EG000|Reported Event|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1-8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
11011831|NCT01114516|BG000|Baseline|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
11011832|NCT01114516|BG001|Baseline|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
11011833|NCT01114516|BG002|Baseline|Total|Total of all reporting groups
11011834|NCT01114516|FG000|Participant Flow|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
11011835|NCT01114516|FG001|Participant Flow|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
11011836|NCT01114516|OG000|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
11011837|NCT01114516|OG001|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
11011838|NCT01114516|EG000|Reported Event|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
11011839|NCT01114516|EG001|Reported Event|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
11011840|NCT01114529|BG000|Baseline|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
11011841|NCT01114529|BG001|Baseline|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
11011842|NCT01114529|BG002|Baseline|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
11011843|NCT01114529|BG003|Baseline|Total|Total of all reporting groups
11011844|NCT01114529|FG000|Participant Flow|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
11011845|NCT01114529|FG001|Participant Flow|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
11011846|NCT01114529|FG002|Participant Flow|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
11011847|NCT01114529|OG000|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
11011848|NCT01114529|OG001|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
11011849|NCT01114529|OG002|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid), and steroids
11011850|NCT01114529|OG001|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
11011851|NCT01114529|OG002|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
11011852|NCT01114529|EG000|Reported Event|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
11011853|NCT01114529|EG001|Reported Event|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
11011854|NCT01114529|EG002|Reported Event|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
11011855|NCT01114555|BG000|Baseline|Bevacizumab, Irinotecan and Temozolomide|"This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.~Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays)."
11011856|NCT01114555|FG000|Participant Flow|Bevacizumab, Irinotecan and Temozolomide|"This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.~Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays)."
11011857|NCT01114555|OG000|Outcome|Bevacizumab, Irinotecan and Temozolomide|"This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.~Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays)."
11011858|NCT01114555|EG000|Reported Event|Bevacizumab, Irinotecan and Temozolomide|"This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.~Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays)."
11011859|NCT01114581|BG000|Baseline|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
11011860|NCT01114581|BG001|Baseline|Placebo|Given as 2 tablets
11011861|NCT01114581|BG002|Baseline|Total|Total of all reporting groups
11011862|NCT01114581|FG000|Participant Flow|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
11011863|NCT01114581|FG001|Participant Flow|Placebo|Given as 2 tablets
11011864|NCT01114581|OG000|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
11011865|NCT01114581|OG001|Outcome|Placebo|Given as 2 tablets
11011866|NCT01114581|EG000|Reported Event|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
11011867|NCT01114581|EG001|Reported Event|Placebo|Given as 2 tablets
11011868|NCT01114620|BG000|Baseline|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
11011869|NCT01114620|FG000|Participant Flow|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
11011870|NCT01114620|OG000|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
11011871|NCT01114620|EG000|Reported Event|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
11011872|NCT01114646|BG000|Baseline|Cemented Hip Hemiarthroplasty|This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
11011873|NCT01114646|BG001|Baseline|Press-Fit Hip Hemiarthroplasty|This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
11011874|NCT01114646|BG002|Baseline|Total|Total of all reporting groups
11011875|NCT01114646|FG000|Participant Flow|Cemented Hip Hemiarthroplasty|This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
11011876|NCT01114646|FG001|Participant Flow|Press-Fit Hip Hemiarthroplasty|This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
11011877|NCT01114646|OG000|Outcome|Cemented Hip Hemiarthroplasty|This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
11011878|NCT01114646|OG001|Outcome|Press-Fit Hip Hemiarthroplasty|This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
11011879|NCT01114646|EG000|Reported Event|Cemented Hip Hemiarthroplasty|This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
11011880|NCT01114646|EG001|Reported Event|Press-Fit Hip Hemiarthroplasty|This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
11011881|NCT01114672|BG000|Baseline|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
11011882|NCT01114672|BG001|Baseline|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
11011883|NCT01114672|BG002|Baseline|Total|Total of all reporting groups
11011884|NCT01114672|FG000|Participant Flow|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
11011885|NCT01114672|FG001|Participant Flow|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
11011886|NCT01114672|OG000|Outcome|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
11011887|NCT01114672|OG001|Outcome|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
11011888|NCT01114672|EG000|Reported Event|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
11011889|NCT01114672|EG001|Reported Event|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
11011890|NCT01114724|BG000|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
11011891|NCT01114724|FG000|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
11011892|NCT01114724|OG000|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
11011893|NCT01114724|OG000|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft will the Captivia Delivery System: All subjects will be implanted with this device
11011894|NCT01114724|EG000|Reported Event|1. Dissection|Medtronic Dissection
11011895|NCT01114737|BG000|Baseline|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
11011896|NCT01114737|BG001|Baseline|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
11011897|NCT01114737|BG002|Baseline|Total|Total of all reporting groups
11011898|NCT01114737|FG000|Participant Flow|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
11011899|NCT01114737|FG001|Participant Flow|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
11011900|NCT01114737|OG000|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
11011901|NCT01114737|OG001|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
11011902|NCT01114737|OG000|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
11011903|NCT01114737|OG001|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
11011904|NCT01114737|OG000|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
11011905|NCT01114737|OG000|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
11011906|NCT01114737|OG001|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
11011907|NCT01114737|EG000|Reported Event|Randomized Treatment Period - Placebo|Randomized Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
11011908|NCT01114737|EG001|Reported Event|Randomized Treatment Period - 6R-BH4|Randomized Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
11011909|NCT01114737|EG002|Reported Event|Randomized Treatment Period - Overall|Randomized Treatment Period - All patients
11011910|NCT01114737|EG003|Reported Event|Open-Label Treatment Period - Placebo-6R-BH4|Open-label Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
11011911|NCT01114737|EG004|Reported Event|Open-Label Treatment Period - 6R-BH4|Open-label Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
11011912|NCT01114737|EG005|Reported Event|Open-Label Treatment Period - Overall|Open-label Treatment Period - All patients
11011913|NCT01114737|EG006|Reported Event|6R-BH4 Treatment Period - 6R-BH4|6R-BH4 Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
11011914|NCT01114737|EG007|Reported Event|6R-BH4 Treatment Period - Combined|6R-BH4 Combined Treatments - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
11011915|NCT01114828|BG000|Baseline|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
11011916|NCT01114828|BG001|Baseline|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
11011917|NCT01114828|BG002|Baseline|Total|Total of all reporting groups
11011918|NCT01114828|FG000|Participant Flow|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
11011919|NCT01114828|FG001|Participant Flow|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
11011920|NCT01114828|OG000|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
11011921|NCT01114828|OG001|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
11011922|NCT01114828|EG000|Reported Event|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
11011923|NCT01114828|EG001|Reported Event|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
11011924|NCT01114880|BG000|Baseline|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
11011925|NCT01114880|BG001|Baseline|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
11011926|NCT01114880|BG002|Baseline|Total|Total of all reporting groups
11011927|NCT01114880|FG000|Participant Flow|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
11011928|NCT01114880|FG001|Participant Flow|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
11011929|NCT01114880|OG000|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
11011930|NCT01114880|OG001|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
11011931|NCT01114880|EG000|Reported Event|Adalimumab (Period 1)|Blinded adalimumab from Week 0 to Week 10
11011932|NCT01114880|EG001|Reported Event|Placebo (Period 1)|Blinded placebo from Week 0 to Week 10
11011933|NCT01114880|EG002|Reported Event|Adalimumab/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10
11011934|NCT01114880|EG003|Reported Event|Placebo/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10
11011935|NCT01114893|BG000|Baseline|TRAVATAN|TRAVATAN 0.004% once daily
11011936|NCT01114893|BG001|Baseline|Travoprost Vehicle|Travoprost Vehicle
11011937|NCT01114893|BG002|Baseline|Travoprost Group A|Travoprost Group A
11011938|NCT01114893|BG003|Baseline|Travoprost Group B|Travoprost Group B
11011939|NCT01114893|BG004|Baseline|Travoprost Group C|Travoprost Group C
11011940|NCT01114893|BG005|Baseline|Total|Total of all reporting groups
11011941|NCT01114893|FG000|Participant Flow|TRAVATAN|TRAVATAN 0.004% once daily
11011942|NCT01114893|FG001|Participant Flow|Travoprost Vehicle|Travoprost Vehicle
11011943|NCT01114893|FG002|Participant Flow|Travoprost Group A|Travoprost Group A
11011944|NCT01114893|FG003|Participant Flow|Travoprost Group B|Travoprost Group B
11011945|NCT01114893|FG004|Participant Flow|Travoprost Group C|Travoprost Group C
11011946|NCT01114893|OG000|Outcome|Travatan 0.004% QD|
11011947|NCT01114893|OG001|Outcome|Travoprost Vehicle|
11011948|NCT01114893|OG002|Outcome|Travoprost Group A|
11011949|NCT01114893|OG003|Outcome|Travoprost Group B|
11011950|NCT01114893|OG004|Outcome|Travoprost Group C|
11011951|NCT01114893|EG000|Reported Event|TRAVATAN|TRAVATAN 0.004% once daily
11011952|NCT01114893|EG001|Reported Event|Travoprost Vehicle|Travoprost Vehicle
11011953|NCT01114893|EG002|Reported Event|Travoprost Group A|Travoprost Group A
11011954|NCT01114893|EG003|Reported Event|Travoprost Group B|Travoprost Group B
11011955|NCT01114893|EG004|Reported Event|Travoprost Group C|Travoprost Group C
11011956|NCT01114945|BG000|Baseline|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
11011957|NCT01114945|BG001|Baseline|Video-Mac|Video-Mac device
11011958|NCT01114945|BG002|Baseline|GlideScope|GlideScope device
11011959|NCT01114945|BG003|Baseline|McGrath|MacGrath device
11011960|NCT01114945|BG004|Baseline|Total|Total of all reporting groups
11011961|NCT01114945|FG000|Participant Flow|Video-Mac|Video-Mac device
11011962|NCT01114945|FG001|Participant Flow|GlideScope|GlideScope device
11011963|NCT01114945|FG002|Participant Flow|McGrath|MacGrath
11011964|NCT01114945|FG003|Participant Flow|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
11011965|NCT01114945|OG000|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
11011966|NCT01114945|OG001|Outcome|Video-Mac|Video-Mac device
11011967|NCT01114945|OG002|Outcome|GlideScope|GlideScope device
11011968|NCT01114945|OG003|Outcome|McGrath|MacGrath device
11011969|NCT01114945|OG000|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
11011970|NCT01114945|EG000|Reported Event|Video-Mac|"Video-Mac device used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath"
11011971|NCT01114945|EG001|Reported Event|GlideScope|"GlideScope device used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
11011972|NCT01114945|EG002|Reported Event|McGrath|"McGrath device used during intubation procedure~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
11011973|NCT01114945|EG003|Reported Event|Direct Macintosh Laryngoscopy|"Direct Macintosh Laryngoscopy (DL) used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
11011974|NCT01114971|BG000|Baseline|Fentanyl|"Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm)~Labetalol: Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Esmolol: Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011975|NCT01114971|BG001|Baseline|Labetalol|"Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Fentanyl: Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Esmolol: Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011976|NCT01114971|BG002|Baseline|Esmolol|"Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Fentanyl: Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Labetalol: Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011977|NCT01114971|BG003|Baseline|Total|Total of all reporting groups
11011978|NCT01114971|FG000|Participant Flow|Fentanyl|"Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm)~Labetalol: Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Esmolol: Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011979|NCT01114971|FG001|Participant Flow|Labetalol|"Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Fentanyl: Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Esmolol: Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011980|NCT01114971|FG002|Participant Flow|Esmolol|"Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Fentanyl: Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Labetalol: Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011981|NCT01114971|OG000|Outcome|Fentanyl|"Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm)~Labetalol: Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Esmolol: Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011982|NCT01114971|OG001|Outcome|Labetalol|"Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Fentanyl: Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Esmolol: Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011983|NCT01114971|OG002|Outcome|Esmolol|"Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Fentanyl: Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Labetalol: Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011984|NCT01114971|EG000|Reported Event|Fentanyl|"Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm)~Labetalol: Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Esmolol: Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011985|NCT01114971|EG001|Reported Event|Labetalol|"Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Fentanyl: Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Esmolol: Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011986|NCT01114971|EG002|Reported Event|Esmolol|"Esmolol 10 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Fentanyl: Fentanyl 50 micrograms/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)~Labetalol: Labetalol 5 mg/ml boluses will be given:~at the induction time~at the time before surgical incision, and~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
11011987|NCT01114997|BG000|Baseline|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
11011988|NCT01114997|BG001|Baseline|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
11011989|NCT01114997|BG002|Baseline|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-Induction (Maintenance Infusion):~Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
11148022|NCT01860950|BG000|Baseline|Anodal tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.~anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder"
11011990|NCT01114997|BG003|Baseline|Total|Total of all reporting groups
11011991|NCT01114997|FG000|Participant Flow|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg Post- Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
11011992|NCT01114997|FG001|Participant Flow|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
11011993|NCT01114997|FG002|Participant Flow|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
11011994|NCT01114997|OG000|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
11011995|NCT01114997|OG001|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
11011996|NCT01114997|OG002|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
11011997|NCT01114997|OG002|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine (12.5-25 mcg/kg/min) + Esmolol (7.5-15 mcg/kg/min)"
11011998|NCT01114997|EG000|Reported Event|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
11011999|NCT01114997|EG001|Reported Event|Esmolol|Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Post-Induction: Infusion dose 7.5 - 15 mcg /kg/min
11012000|NCT01114997|EG002|Reported Event|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
11012001|NCT01115101|BG000|Baseline|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
11012002|NCT01115101|BG001|Baseline|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
11012003|NCT01115101|BG002|Baseline|Total|Total of all reporting groups
11012004|NCT01115101|FG000|Participant Flow|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after cesarean section (CS).
11012005|NCT01115101|FG001|Participant Flow|Patient Controlled Device With Pritramid|Patients assigned to the Patient-controlled analgesia (PCA) group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
11012006|NCT01115101|OG000|Outcome|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
11012007|NCT01115101|OG001|Outcome|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
11012008|NCT01115101|EG000|Reported Event|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
11012009|NCT01115101|EG001|Reported Event|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
11012010|NCT01115166|BG000|Baseline|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
11012011|NCT01115166|FG000|Participant Flow|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
11012012|NCT01115166|OG000|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
11012013|NCT01115166|EG000|Reported Event|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
11012014|NCT01115231|BG000|Baseline|Group 1 (Control)|Case control subjects without AMD diagnosis.
11012015|NCT01115231|BG001|Baseline|Group 2 (Age-related Macular Degeneration)|Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
11012016|NCT01115231|BG002|Baseline|Total|Total of all reporting groups
11012017|NCT01115231|FG000|Participant Flow|Group 1 (Control)|Case control subjects without AMD diagnosis.
11012018|NCT01115231|FG001|Participant Flow|Group 2 (Age-related Macular Degeneration)|Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
11012019|NCT01115231|OG000|Outcome|Group 1 (Control)|Case control subjects without AMD diagnosis.
11012020|NCT01115231|OG001|Outcome|Group 2 (Age-related Macular Degeneration)|Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
11012021|NCT01115231|OG000|Outcome|Group 1 (Control)|Case control subjects without AMD diagnosis
11012022|NCT01115231|EG000|Reported Event|Group 1 (Control)|Case control subjects without AMD diagnosis.
11012023|NCT01115231|EG001|Reported Event|Group 2 (Age-related Macular Degeneration)|Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
11012024|NCT01115309|BG000|Baseline|XprESS Balloon Device|XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
11012025|NCT01115309|FG000|Participant Flow|XprESS Balloon Device|XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
11012026|NCT01115309|OG000|Outcome|XprESS Balloon Device|XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
11012027|NCT01115309|OG000|Outcome|XprESS Balloon Device Long-term Follow-up|Fifty participants who were enrolled in the long-term follow-up.
11012028|NCT01115309|EG000|Reported Event|XprESS Balloon Device|XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
11012029|NCT01115452|BG000|Baseline|Overall Study|
11012030|NCT01115452|FG000|Participant Flow|5% or 2.5% Potassium Nitrate Solution or Water|Investigator applied the participants with 5% potassium nitrate solution or 2.5% potassium nitrate solution or water to a single sensitive tooth for two minutes (mins), in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
11012031|NCT01115452|OG000|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
11012032|NCT01115452|OG001|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment
11012033|NCT01115452|OG001|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
11012034|NCT01115452|OG002|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
11012035|NCT01115452|OG001|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment..
11012036|NCT01115452|EG000|Reported Event|Overall Study|
11012037|NCT01115491|BG000|Baseline|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
11012038|NCT01115491|FG000|Participant Flow|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg per square meter (mg/m^2), orally (PO), on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
11012039|NCT01115491|OG000|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
11012040|NCT01115491|EG000|Reported Event|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
11012041|NCT01115517|BG000|Baseline|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
11012042|NCT01115517|BG001|Baseline|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
11012043|NCT01115517|BG002|Baseline|Total|Total of all reporting groups
11012044|NCT01115517|FG000|Participant Flow|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
11012045|NCT01115517|FG001|Participant Flow|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
11148023|NCT01860950|BG001|Baseline|Anodal tDCS Plus Pain-education|"Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder.~Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder"
11012046|NCT01115517|OG000|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
11012047|NCT01115517|OG001|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
11012048|NCT01115517|EG000|Reported Event|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
11012049|NCT01115517|EG001|Reported Event|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
11012050|NCT01115556|BG000|Baseline|Lucentis 2.0 mg|Lucentis (ranibizumab) 2.0 mg
11012051|NCT01115556|BG001|Baseline|Lucentis 0.5 mg|Lucentis (ranibizumab) 0.5 mg
11148024|NCT01860950|BG002|Baseline|Cathodal tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.~cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC."
11148025|NCT01860950|BG003|Baseline|Cathodal tDCS Plus Pain-education|"Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode attached to the right shoulder and the cathode electrode was placed over the left DLPFC. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC."
11148026|NCT01860950|BG004|Baseline|Sham tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.~sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session"
11148027|NCT01860950|BG005|Baseline|Sham tDCS Plus Pain-education|"Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session"
11148028|NCT01860950|BG006|Baseline|Total|Total of all reporting groups
11148029|NCT01860950|FG000|Participant Flow|Anodal tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.~anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder"
11148030|NCT01860950|FG001|Participant Flow|Anodal tDCS Plus Pain-education|"Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder.~Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder"
11148031|NCT01860950|FG002|Participant Flow|Cathodal tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.~cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC."
11148032|NCT01860950|FG003|Participant Flow|Cathodal tDCS Plus Pain-education|"Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode attached to the right shoulder and the cathode electrode was placed over the left DLPFC. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC."
11148033|NCT01860950|FG004|Participant Flow|Sham tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.~sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session"
11148034|NCT01860950|FG005|Participant Flow|Sham tDCS Plus Pain-education|"Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session"
11012052|NCT01115556|BG002|Baseline|Total|Total of all reporting groups
11012053|NCT01115556|FG000|Participant Flow|Lucentis 2.0 mg|Lucentis (ranibizumab) 2.0 mg
11012054|NCT01115556|FG001|Participant Flow|Lucentis 0.5 mg|Lucentis (ranibizumab) 0.5 mg
11012055|NCT01115556|OG000|Outcome|Lucentis 2.0 mg|Lucentis (ranibizumab) 2.0 mg
11012056|NCT01115556|OG001|Outcome|Lucentis 0.5 mg|Lucentis (ranibizumab) 0.5 mg
11012057|NCT01115556|OG000|Outcome|Lucentis 2.0 mg|"Lucentis 2.0 mg~Ranibizumab: 2.0 mg"
11012058|NCT01115556|OG001|Outcome|LUCENTIS 0.5 mg|Ranibizumab: 0.5 mg
11012059|NCT01115556|EG000|Reported Event|Lucentis 2.0 mg|Lucentis (ranibizumab) 2.0 mg
11012060|NCT01115556|EG001|Reported Event|Lucentis 0.5 mg|Lucentis (ranibizumab) 0.5 mg
11012061|NCT01115569|BG000|Baseline|Open-label Hydrocodone Bitartate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
11012062|NCT01115569|FG000|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
11012063|NCT01115569|FG001|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-ER in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
11012064|NCT01115569|OG000|Outcome|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
11012065|NCT01115569|EG000|Reported Event|Conversion/Titration Phase|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release (HC-ER) capsules daily for up to 6 weeks
11012066|NCT01115569|EG001|Reported Event|Maintenance Treatment Phase|"Maintenance Hydrocodone Bitartrate Extended Release (HC-ER) Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
11012067|NCT01115582|BG000|Baseline|Cholic Acid|All patients entered and treated
11012068|NCT01115582|FG000|Participant Flow|Cholic Acid|All patients entered and treated
11012069|NCT01115582|OG000|Outcome|Cholic Acid|All patients entered and treated
11012070|NCT01115582|EG000|Reported Event|Cholic Acid|All patients entered and treated
11012071|NCT01115660|BG000|Baseline|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
11012072|NCT01115660|BG001|Baseline|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
11012073|NCT01115660|BG002|Baseline|Total|Total of all reporting groups
11012074|NCT01115660|FG000|Participant Flow|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
11012075|NCT01115660|FG001|Participant Flow|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
11012076|NCT01115660|OG000|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
11012077|NCT01115660|OG001|Outcome|Control|standard of care
11012078|NCT01115660|EG000|Reported Event|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
11012079|NCT01115660|EG001|Reported Event|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
11012080|NCT01115673|BG000|Baseline|ACE-1000|1000 mg Acetaminophen Caplet
11012081|NCT01115673|BG001|Baseline|ACE-650|650 mg Acetaminophen Caplet
11012082|NCT01115673|BG002|Baseline|ACE-0|0 mg Acetaminophen Caplet
11012083|NCT01115673|BG003|Baseline|Total|Total of all reporting groups
11012084|NCT01115673|FG000|Participant Flow|ACE-1000|1000 mg Acetaminophen Caplet
11012085|NCT01115673|FG001|Participant Flow|ACE-650|650 mg Acetaminophen Caplet
11012086|NCT01115673|FG002|Participant Flow|ACE-0|0 mg Acetaminophen Caplet
11012087|NCT01115673|OG000|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
11012088|NCT01115673|OG001|Outcome|ACE-650|650 mg Acetaminophen Caplet
11012089|NCT01115673|OG002|Outcome|ACE-0|0 mg Acetaminophen Caplet
11012090|NCT01115673|EG000|Reported Event|ACE-1000|1000 mg Acetaminophen Caplet
11012091|NCT01115673|EG001|Reported Event|ACE-650|650 mg Acetaminophen Caplet
11012092|NCT01115673|EG002|Reported Event|ACE-0|0 mg Acetaminophen Caplet
11012093|NCT01115738|BG000|Baseline|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012094|NCT01115738|BG001|Baseline|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012095|NCT01115738|BG002|Baseline|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012096|NCT01115738|BG003|Baseline|Total|Total of all reporting groups
11012097|NCT01115738|FG000|Participant Flow|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11150189|NCT01876251|EG001|Reported Event|PF-03084014 100 mg BID + Docetaxel 100 mg/m^2|PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
11012098|NCT01115738|FG001|Participant Flow|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012099|NCT01115738|FG002|Participant Flow|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012100|NCT01115738|OG000|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012101|NCT01115738|OG001|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012102|NCT01115738|OG002|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012103|NCT01115738|OG000|Outcome|Clopidogrel at Baseline -CYP2C19 EM|600-milligram (mg) clopidogrel loading dose (LD) administered once orally before percutaneous coronary intervention (PCI).
11012104|NCT01115738|OG001|Outcome|Clopidogrel at Baseline - CYP2C19 RM|600-mg clopidogrel LD administered once orally before PCI.
11012105|NCT01115738|OG000|Outcome|Placebo and 60 mg Prasugrel-CYP2C19 EM|CYP2C19 extensive metabolizers treated with placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012106|NCT01115738|OG001|Outcome|Placebo and 60 mg Prasugrel -CYP2C19 RM|CYP2C19 reduced metabolizers treated with placebo LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012107|NCT01115738|OG002|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012108|NCT01115738|OG003|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012109|NCT01115738|OG004|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012110|NCT01115738|OG005|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012111|NCT01115738|EG000|Reported Event|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012112|NCT01115738|EG001|Reported Event|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012113|NCT01115738|EG002|Reported Event|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
11012114|NCT01115803|BG000|Baseline|Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD|50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012115|NCT01115803|BG001|Baseline|Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD|50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012116|NCT01115803|BG002|Baseline|Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD|100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012117|NCT01115803|BG003|Baseline|Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD|75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012118|NCT01115803|BG004|Baseline|Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD|50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012119|NCT01115803|BG005|Baseline|Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD|100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012120|NCT01115803|BG006|Baseline|Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD|50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012121|NCT01115803|BG007|Baseline|Total|Total of all reporting groups
11012122|NCT01115803|FG000|Participant Flow|Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD|50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012123|NCT01115803|FG001|Participant Flow|Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD|50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012124|NCT01115803|FG002|Participant Flow|Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD|100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012125|NCT01115803|FG003|Participant Flow|Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD|75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012126|NCT01115803|FG004|Participant Flow|Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD|50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012127|NCT01115803|FG005|Participant Flow|Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD|100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012128|NCT01115803|FG006|Participant Flow|Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD|50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012129|NCT01115803|OG000|Outcome|LY2584702 + Erlotinib|Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.
11012130|NCT01115803|OG001|Outcome|LY2584702+Everolimus|Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.
11012131|NCT01115803|OG000|Outcome|Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD|50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012132|NCT01115803|OG001|Outcome|Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD|50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012133|NCT01115803|OG002|Outcome|Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD|100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012134|NCT01115803|OG003|Outcome|Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD|75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012135|NCT01115803|OG004|Outcome|Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD|50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012136|NCT01115803|OG005|Outcome|Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD|100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012137|NCT01115803|OG006|Outcome|Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD|50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
11012138|NCT01115803|OG000|Outcome|Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD|50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 2 28-day cycles.
11012139|NCT01115803|OG001|Outcome|Arm A - 50 mg LY2584702 (BID) + 150 mg Erlotinib QD|50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012140|NCT01115803|OG000|Outcome|Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD|50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
11012141|NCT01115803|EG000|Reported Event|Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD|50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for 2 28-day cycles.
11012142|NCT01115803|EG001|Reported Event|Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD|50 mg LY2584702 administered orally twice daily BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.
11012143|NCT01115803|EG002|Reported Event|Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD|100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.
11012144|NCT01115803|EG003|Reported Event|Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD|75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.
11012145|NCT01115803|EG004|Reported Event|Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD|50 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.
11012146|NCT01115803|EG005|Reported Event|Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD|100 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.
11012147|NCT01115803|EG006|Reported Event|Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD|50 mg LY2584702 administered orally BID plus 150 mg everolimus administered orally QD for 2 28-day cycles.
11012148|NCT01115855|BG000|Baseline|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
11012149|NCT01115855|BG001|Baseline|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
11012150|NCT01115855|BG002|Baseline|Total|Total of all reporting groups
11012151|NCT01115855|FG000|Participant Flow|Eplerenone|Participants with estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 50 milliliter per minute divided by 1.73 squared meter (mL/min/1.73m^2) received eplerenone 25 milligram (mg) tablet once daily up to Week 4 and participants with eGFR 30 to less than (<) 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. . From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
11012152|NCT01115855|FG001|Participant Flow|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
11012153|NCT01115855|OG000|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
11225527|NCT02369068|BG000|Baseline|Onabotulinumtoxin A|"Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.~An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).~Onabotulinumtoxin A: Intravaginal pelvic floor injection one series"
11225528|NCT02369068|BG001|Baseline|Kenalog|"Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.~A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).~Kenalog: Intravaginal pelvic floor injection one series"
11225529|NCT02369068|BG002|Baseline|Total|Total of all reporting groups
11225530|NCT02369068|FG000|Participant Flow|Onabotulinumtoxin A|"Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.~An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).~Onabotulinumtoxin A: Intravaginal pelvic floor injection one series"
11225531|NCT02369068|FG001|Participant Flow|Kenalog|"Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.~A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).~Kenalog: Intravaginal pelvic floor injection one series"
11225532|NCT02369068|OG000|Outcome|Onabotulinumtoxin A|"Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.~An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).~Onabotulinumtoxin A: Intravaginal pelvic floor injection one series"
11225533|NCT02369068|OG001|Outcome|Kenalog|"Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.~A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).~Kenalog: Intravaginal pelvic floor injection one series"
11225534|NCT02369068|EG000|Reported Event|Onabotulinumtoxin A|"Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.~An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).~Onabotulinumtoxin A: Intravaginal pelvic floor injection one series"
11225535|NCT02369068|EG001|Reported Event|Kenalog|"Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.~A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).~Kenalog: Intravaginal pelvic floor injection one series"
11225536|NCT02369159|BG000|Baseline|Peramivir|"Age-appropriate single dose Peramivir, administered as a single short iv infusion:~Subjects ≥12 years - 600 mg. Subjects <12 years - 12 mg/kg (max. 600 mg). Subjects < 6 months - 8 mg/kg."
11225537|NCT02369159|BG001|Baseline|Oseltamivir|"Age appropriate oral dose of Oseltamivir BID for 5 days:~Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects < 13 years - weight-based dose as a capsule or oral suspension."
11225538|NCT02369159|BG002|Baseline|Total|Total of all reporting groups
11012154|NCT01115855|OG001|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
11225539|NCT02369159|FG000|Participant Flow|Peramivir|"Age-appropriate dose Peramivir, administered as a single short iv infusion:~Subjects ≥12 years - 600 mg. Subjects <12 years - 12 mg/kg (max. 600 mg). Subjects < 6 months - 8 mg/kg."
11225540|NCT02369159|FG001|Participant Flow|Oseltamivir|"Age appropriate oral dose of Oseltamivir BID for 5 days:~Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects < 13 years - weight-based dose as a capsule or oral suspension."
11225541|NCT02369159|OG000|Outcome|Peramivir|"Age-appropriate single dose Peramivir, administered as a single short iv infusion:~Subjects ≥12 years - 600 mg. Subjects <12 years - 12 mg/kg (max. 600 mg). Subjects < 6 months - 8 mg/kg."
11225542|NCT02369159|OG001|Outcome|Oseltamivir|"Age appropriate oral dose of Oseltamivir BID for 5 days:~Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects < 13 years - weight-based dose as a capsule or oral suspension."
11225543|NCT02369159|OG000|Outcome|Peramivir (≥ 28 Days - < 2 Years)|"Age-appropriate dose Peramivir, administered as a single short iv infusion:~Subjects <2 years - 12 mg/kg (max. 600 mg). Subjects < 6 months - 8 mg/kg."
11225544|NCT02369159|OG001|Outcome|Peramivir (≥ 2 - < 7 Years)|12 mg/kg (max. 600 mg) dose Peramivir, administered as a single short iv infusion
11225545|NCT02369159|OG002|Outcome|Peramivir (≥ 7 - < 13 Years)|"Age-appropriate dose Peramivir, administered as a single short iv infusion:~Subjects ≥12 years - 600 mg. Subjects <12 years - 12 mg/kg (max. 600 mg)."
11225546|NCT02369159|OG003|Outcome|Peramivir (≥ 13 - < 18 Years)|600 mg dose Peramivir, administered as a single short iv infusion
11225547|NCT02369159|OG001|Outcome|Oseltamivir (≥ 28 Days - < 2 Years)|Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
11225548|NCT02369159|OG002|Outcome|Peramivir (≥ 2 - < 7 Years)|12 mg/kg (max. 600 mg) dose Peramivir, administered as a single short iv infusion
11225549|NCT02369159|OG003|Outcome|Oseltamivir (≥ 2 - < 7 Years)|Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
11225550|NCT02369159|OG004|Outcome|Peramivir (≥ 7 - < 13 Years)|"Age-appropriate dose Peramivir, administered as a single short iv infusion:~Subjects ≥12 years - 600 mg. Subjects <12 years - 12 mg/kg (max. 600 mg)."
11012155|NCT01115855|EG000|Reported Event|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
11012156|NCT01115855|EG001|Reported Event|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
11012157|NCT01115933|BG000|Baseline|XIENCE PRIME SV EECSS|"XIENCE PRIME SV Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
11012158|NCT01115933|FG000|Participant Flow|XIENCE PRIME SV EECSS|"XIENCE PRIME SV EECSS: XIENCE PRIME Small Vessel (2.25 mm) Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS"
11012159|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012160|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS EECSS : Patients receiving XIENCE PRIME SV EECSS
11012161|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS %DS In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012162|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS %DS In-stent|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012163|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS %DS Proximal|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012164|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS %DS Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012165|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS LL In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012166|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS LL In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012167|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS LL Proximal|XIENCE PRIME SV EECSS: Patients receivingXIENCE PRIME SV EECSS
11012168|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS LL Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012169|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS ABR In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012170|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS ABR In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012171|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS ABR Proximal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012172|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS ABR Distal|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
11012173|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS - Cardiac|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012174|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS - Vascular|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
11012175|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
11012176|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS - All Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012177|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS - Cardiac Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012178|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - Vascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012179|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
11012180|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012181|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012182|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
11012183|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012184|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
11012185|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012186|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012187|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS- TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012188|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012189|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012190|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012191|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012192|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012193|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012194|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012195|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012196|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012197|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per Protocol|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012198|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012199|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012200|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012201|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012202|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012203|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012204|NCT01115933|OG003|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012205|NCT01115933|OG004|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
11012206|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012207|NCT01115933|OG004|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012208|NCT01115933|OG000|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012209|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012210|NCT01115933|OG004|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
11012211|NCT01115933|OG001|Outcome|XIENCE PRIME SV EECSS- ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
11012212|NCT01115933|OG002|Outcome|XIENCE PRIME SV EECSS - ST Possible|"XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
11012213|NCT01115933|EG000|Reported Event|AVJ-09-385 SV EECSS|"SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System~AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS"
11012214|NCT01115998|BG000|Baseline|Power Wheelchair|
11012215|NCT01115998|BG001|Baseline|Control Group|Children received usual early intervention services, but no power wheelchair.
11012216|NCT01115998|BG002|Baseline|Total|Total of all reporting groups
11012217|NCT01115998|FG000|Participant Flow|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
11012218|NCT01115998|FG001|Participant Flow|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
11012219|NCT01115998|OG000|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
11012220|NCT01115998|OG001|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
11012221|NCT01115998|EG000|Reported Event|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
11012222|NCT01115998|EG001|Reported Event|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
11012223|NCT01116024|BG000|Baseline|Aortic Valve Replacement|3f Enable Aortic Bioprosthesis Model 6000
11012224|NCT01116024|FG000|Participant Flow|ATS 3f Enable Aortic Bioprosthesis Model 6000|ATS 3f Enable Aortic Bioprosthesis Model 6000 : Replacement Aortic Heart Valve
11012225|NCT01116024|OG000|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
11012226|NCT01116024|OG000|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
11012227|NCT01116024|OG000|Outcome|NYHA Class Preoperative|Preoperative numbers of NYHA classification.
11012228|NCT01116024|OG001|Outcome|NYHA Class 3-6 Months|NYHA classification after 3-6 months.
11012229|NCT01116024|OG002|Outcome|NYHA Class 11-14 Months|NYHA classification after 11-14 months.
11012230|NCT01116024|OG003|Outcome|NYHA Class 2 Year|NYHA classification after 2 years.
11012231|NCT01116024|OG004|Outcome|NYHA Class 3 Year|NYHA classification after 3 years.
11012232|NCT01116024|OG005|Outcome|NYHA Class 4 Year|NYHA classification after 4 years.
11012233|NCT01116024|OG006|Outcome|NYHA Class 5 Year|NYHA classification after 5 years.
11012234|NCT01116024|OG000|Outcome|Discharge|Gradient at discharge
11012235|NCT01116024|OG001|Outcome|3-6 Months|Gradient at 3-6 Months
11012236|NCT01116024|OG002|Outcome|11-14 Months|Gradient at 11-14 months
11012237|NCT01116024|OG003|Outcome|2 Years|Gradient at 2 Years
11012238|NCT01116024|OG004|Outcome|3 Years|Gradient at 3 Years
11012239|NCT01116024|OG005|Outcome|4 Years|Gradient at 4 Years
11012240|NCT01116024|OG006|Outcome|5 Years|Gradient at 5 Years
11012241|NCT01116024|OG000|Outcome|Discharge|Effective Orifice Area at discharge
11012242|NCT01116024|OG001|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
11012243|NCT01116024|OG002|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
11012244|NCT01116024|OG003|Outcome|2 Years|Effective Orifice Area at 2 years
11012245|NCT01116024|OG004|Outcome|3 Years|Effective Orifice Area at 3 years
11012246|NCT01116024|OG005|Outcome|4 Years|Effective Orifice Area at 4 years
11012247|NCT01116024|OG006|Outcome|5 Years|Effective Orifice Area at 5 years
11012248|NCT01116024|EG000|Reported Event|Enable I Model 6000 Valve|Adverse events relating to the study safety endpoints.
11012249|NCT01116037|BG000|Baseline|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
11012250|NCT01116037|FG000|Participant Flow|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
11012251|NCT01116037|OG000|Outcome|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
11012252|NCT01116037|EG000|Reported Event|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
11012253|NCT01116102|BG000|Baseline|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
11012254|NCT01116102|BG001|Baseline|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
11012255|NCT01116102|BG002|Baseline|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
11012256|NCT01116102|BG003|Baseline|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
11012257|NCT01116102|BG004|Baseline|25 ga Needle, Dose Flush, Single-step Rate Scheme|
11012258|NCT01116102|BG005|Baseline|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
11012259|NCT01116102|BG006|Baseline|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
11012260|NCT01116102|BG007|Baseline|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
11012261|NCT01116102|BG008|Baseline|Total|Total of all reporting groups
11012262|NCT01116102|FG000|Participant Flow|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
11012263|NCT01116102|FG001|Participant Flow|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
11012264|NCT01116102|FG002|Participant Flow|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
11012265|NCT01116102|FG003|Participant Flow|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
11012266|NCT01116102|FG004|Participant Flow|25 ga Needle, Dose Flush, Single-step Rate Scheme|
11012267|NCT01116102|FG005|Participant Flow|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
11012268|NCT01116102|FG006|Participant Flow|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
11012269|NCT01116102|FG007|Participant Flow|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
11012270|NCT01116102|OG000|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
11012271|NCT01116102|OG001|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
11012272|NCT01116102|OG002|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
11012273|NCT01116102|OG003|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
11012274|NCT01116102|OG004|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
11012275|NCT01116102|OG005|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
11012276|NCT01116102|OG006|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
11012277|NCT01116102|OG007|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
11012278|NCT01116102|EG000|Reported Event|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
11012279|NCT01116102|EG001|Reported Event|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
11012280|NCT01116102|EG002|Reported Event|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
11012281|NCT01116102|EG003|Reported Event|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
11012282|NCT01116102|EG004|Reported Event|25 ga Needle, Dose Flush, Single-step Rate Scheme|
11012283|NCT01116102|EG005|Reported Event|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
11012284|NCT01116102|EG006|Reported Event|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
11012285|NCT01116102|EG007|Reported Event|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
11012286|NCT01116401|BG000|Baseline|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
11012287|NCT01116401|FG000|Participant Flow|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
11012288|NCT01116401|OG000|Outcome|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
11012289|NCT01116401|EG000|Reported Event|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
11012290|NCT01116427|BG000|Baseline|Abatacept First, Then Placebo|Subjects received abatacept IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows: Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
11150190|NCT01876251|EG002|Reported Event|PF-03084014 150 mg BID + Docetaxel 75 mg/m^2|PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
11012291|NCT01116427|BG001|Baseline|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
11012292|NCT01116427|BG002|Baseline|Total|Total of all reporting groups
11012293|NCT01116427|FG000|Participant Flow|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
11012294|NCT01116427|FG001|Participant Flow|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
11012295|NCT01116427|OG000|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
11012296|NCT01116427|OG001|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
11012297|NCT01116427|EG000|Reported Event|Core Phase: Abatacept -> Placebo|"Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. Dosing of abatacept was as follows:~Participants weighing-~less than 60 kg received 500 mg;~60-100 kg received 750 mg; and~greater than 100 kg received 1 g."
11012298|NCT01116427|EG001|Reported Event|Core Phase: Placebo -> Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24.
11012299|NCT01116427|EG002|Reported Event|Extension Phase: Abatacept -> Placebo|After week 24, participants in Abatacept -> Placebo group eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52.
11012300|NCT01116427|EG003|Reported Event|Extension Phase: Placebo -> Abatacept|"After week 24, participants in the Placebo -> Abatacept group eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Dosing of abatacept was as follows:~Participants weighing-~less than 60 kg received 500 mg;~60-100 kg received 750 mg; and~greater than 100 kg received 1 g."
11012301|NCT01116427|EG004|Reported Event|Follow-up Phase: Abatacept -> Placebo|Following Week 52, participants in the Abatacept -> Placebo group completed an additional 12 weeks of observation until week 64.
11012302|NCT01116427|EG005|Reported Event|Follow-up Phase: Placebo -> Abatacept|Following Week 52, participants in the Placebo -> Abatacept group completed an additional 12 weeks of observation until week 64.
11012303|NCT01116440|BG000|Baseline|BGS649 Co-administered With Levora 28™|BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
11012304|NCT01116440|BG001|Baseline|Placebo Co-administered With Levora 28™|Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
11012305|NCT01116440|BG002|Baseline|Total|Total of all reporting groups
11012306|NCT01116440|FG000|Participant Flow|BGS649 Co-administered With Levora 28™|BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site.
11012307|NCT01116440|FG001|Participant Flow|Placebo Co-administered With Levora 28™|Placebo: Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.
11012308|NCT01116440|OG000|Outcome|BGS649 Co-administered With Levora 28™|BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
11012309|NCT01116440|OG001|Outcome|Placebo Co-administered With Levora 28™|Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
11012310|NCT01116440|OG000|Outcome|BGS649 Co-administered With Levora 28™|BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site.
11012311|NCT01116440|OG001|Outcome|Placebo Co-administered With Levora 28™|Placebo: Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.
11012312|NCT01116440|EG000|Reported Event|BGS649 Co-administered With Levora 28™|BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
11012313|NCT01116440|EG001|Reported Event|Placebo Co-administered With Levora 28™|Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
11012314|NCT01116466|BG000|Baseline|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
11012315|NCT01116466|FG000|Participant Flow|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
11012316|NCT01116466|OG000|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
11012317|NCT01116466|OG000|Outcome|ActiGait|"Receiving ActiGait - implantable drop foot stimulator~ActiGait: ActiGait - implantable drop foot stimulator"
11012318|NCT01116466|EG000|Reported Event|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
11012319|NCT01116544|BG000|Baseline|AMES Therapy With EMG Biofeedback|The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
11012320|NCT01116544|BG001|Baseline|AMES Therapy With Torque Biofeedback|The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
11012321|NCT01116544|BG002|Baseline|Total|Total of all reporting groups
11012322|NCT01116544|FG000|Participant Flow|AMES Therapy With EMG Biofeedback|The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
11012323|NCT01116544|FG001|Participant Flow|AMES Therapy With Torque Biofeedback|The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
11012324|NCT01116544|OG000|Outcome|AMES Therapy With EMG Biofeedback|The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
11012325|NCT01116544|OG001|Outcome|AMES Therapy With Torque Biofeedback|The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
11012326|NCT01116544|EG000|Reported Event|AMES Therapy With EMG Biofeedback|The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
11012327|NCT01116544|EG001|Reported Event|AMES Therapy With Torque Biofeedback|The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
11012328|NCT01116661|BG000|Baseline|5 - Aminolevuline Acid in Patients With HGG|5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
11012329|NCT01116661|FG000|Participant Flow|Single Dose ALA for Newly Diagnosed and Recurrent HGG|5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery for both newly diagnosed and recurrent High grade gliomas
11012330|NCT01116661|OG000|Outcome|5- Aminolevuline Acid Given to HGG Participants|5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
11012331|NCT01116661|EG000|Reported Event|5- Aminolevuline Acid Given to HGG Participants|5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
11012332|NCT01116687|BG000|Baseline|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
11012333|NCT01116687|FG000|Participant Flow|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
11012334|NCT01116687|OG000|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
11012335|NCT01116687|EG000|Reported Event|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
11150191|NCT01876329|BG000|Baseline|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
11225551|NCT02369159|OG005|Outcome|Oseltamivir (≥ 7 - < 13 Years)|Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
11225552|NCT02369159|OG006|Outcome|Peramivir (≥ 13 - < 18 Years)|600 mg dose Peramivir, administered as a single short iv infusion
11225553|NCT02369159|OG007|Outcome|Oseltamivir (≥ 13 - < 18 Years)|75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.
11225554|NCT02369159|EG000|Reported Event|Peramivir|"Age-appropriate single dose Peramivir, administered as a single short iv infusion:~Subjects ≥12 years - 600 mg. Subjects <12 years - 12 mg/kg (max. 600 mg). Subjects < 6 months - 8 mg/kg."
11225555|NCT02369159|EG001|Reported Event|Oseltamivir|"Age appropriate oral dose of Oseltamivir BID for 5 days:~Subjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects < 13 years - weight-based dose as a capsule or oral suspension."
11225556|NCT02369172|BG000|Baseline|Bupropion + ASP2151|"400 mg ASP2151 followed by 150 mg Bupropion~Bupropion~ASP2151"
11225557|NCT02369172|FG000|Participant Flow|Bupropion + ASP2151|"400 mg ASP2151 followed by 150 mg Bupropion~Bupropion~ASP2151"
11225558|NCT02369172|OG000|Outcome|Day 1|150 mg bupropion alone
11225559|NCT02369172|OG001|Outcome|Day 15|150 mg bupropion with 400 mg ASP2151
11225560|NCT02369172|OG002|Outcome|Day 22|150 mg bupropion alone
11225561|NCT02369172|OG003|Outcome|Day 29|150 mg bupropion alone
11225562|NCT02369172|OG000|Outcome|All Subjects|All subjects
11225563|NCT02369172|OG000|Outcome|Day 6|Day 6 pre-dose
11225564|NCT02369172|OG001|Outcome|Day 7|Day 7 pre-dose
11225565|NCT02369172|OG002|Outcome|Day 8|Day 8 pre-dose
11225566|NCT02369172|OG003|Outcome|Day 9|Day 9 pre-dose
11225567|NCT02369172|OG004|Outcome|Day 10|Day 10 pre-dose
11225568|NCT02369172|OG005|Outcome|Day 11|Day 11 pre-dose
11225569|NCT02369172|OG006|Outcome|Day 12|Day 12 pre-dose
11225570|NCT02369172|OG007|Outcome|Day 13|Day 13 pre-dose
11225571|NCT02369172|OG008|Outcome|Day 14|Day 14 pre-dose
11225572|NCT02369172|OG009|Outcome|Day 15|Day 15 pre-dose
11225573|NCT02369172|OG000|Outcome|Day 15|150 mg bupropion with 400 mg ASP2151
11225574|NCT02369172|EG000|Reported Event|Bupropion|after dosing with bupropion on Day 1 and before the first dose of ASP2151 on Day 6.
11225575|NCT02369172|EG001|Reported Event|ASP2151 After Bupropion|after the first dose of ASP2151 on Day 6, and before co-administration of bupropion and ASP2151 on Day 15.
11225576|NCT02369172|EG002|Reported Event|Bupropion With ASP2151|after co-administration of bupropion and ASP2151 on Day 15.
11225577|NCT02369172|EG003|Reported Event|Total|
11225578|NCT02369211|BG000|Baseline|Intravenous Acetaminophen|"Patient receives 1g intravenous acetaminophen after the incision~Acetaminophen (Ofirmev)"
11225579|NCT02369211|BG001|Baseline|Placebo|"Patient receives saline injection instead of the study drug~Placebo"
11225580|NCT02369211|BG002|Baseline|Total|Total of all reporting groups
11225581|NCT02369211|FG000|Participant Flow|Intravenous Acetaminophen|"Patient receives 1g intravenous acetaminophen after the incision~Acetaminophen (Ofirmev)"
11225582|NCT02369211|FG001|Participant Flow|Placebo|"Patient receives saline injection instead of the study drug~Placebo"
11225583|NCT02369211|OG000|Outcome|Intravenous Acetaminophen|"Patient receives 1g intravenous acetaminophen after the incision~Acetaminophen (Ofirmev)"
11225584|NCT02369211|OG001|Outcome|Placebo|"Patient receives saline injection instead of the study drug~Placebo"
11225585|NCT02369211|EG000|Reported Event|Intravenous Acetaminophen|"Patient receives 1g intravenous acetaminophen after the incision~Acetaminophen (Ofirmev)"
11225586|NCT02369211|EG001|Reported Event|Placebo|"Patient receives saline injection instead of the study drug~Placebo"
11225587|NCT02369341|BG000|Baseline|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11225588|NCT02369341|BG001|Baseline|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11225589|NCT02369341|BG002|Baseline|Total|Total of all reporting groups
11225590|NCT02369341|FG000|Participant Flow|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11225591|NCT02369341|FG001|Participant Flow|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11225592|NCT02369341|OG000|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11225593|NCT02369341|OG001|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11225594|NCT02369341|OG000|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
11225595|NCT02369341|OG001|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
11225596|NCT02369341|OG002|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
11225597|NCT02369341|OG003|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
11012336|NCT01116739|BG000|Baseline|COHS Administered Fluoride Varnish and Oral Health Education|"Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.~Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.~Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries."
11012337|NCT01116739|BG001|Baseline|Usual Care|"Usual care will include regular dental services provided by the Indian Health Service.~Dental services delivered by the Indian Health Service."
11012338|NCT01116739|BG002|Baseline|Total|Total of all reporting groups
11012339|NCT01116739|FG000|Participant Flow|COHS Administered Fluoride Varnish and Oral Health Education|"Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.~Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.~Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries."
11012340|NCT01116739|FG001|Participant Flow|Usual Care|"Usual care will include regular dental services provided by the Indian Health Service.~Dental services delivered by the Indian Health Service."
11012341|NCT01116739|OG000|Outcome|COHS Administered Fluoride Varnish and Oral Health Education|"Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.~Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.~Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries."
11012342|NCT01116739|OG001|Outcome|Usual Care|"Usual care will include regular dental services provided by the Indian Health Service.~Dental services delivered by the Indian Health Service."
11012343|NCT01116739|EG000|Reported Event|COHS Administered Fluoride Varnish and Oral Health Education|"Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.~Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.~Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries."
11012344|NCT01116739|EG001|Reported Event|Usual Care|"Usual care will include regular dental services provided by the Indian Health Service.~Dental services delivered by the Indian Health Service."
11012345|NCT01116882|BG000|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
11225598|NCT02369341|EG000|Reported Event|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11225599|NCT02369341|EG001|Reported Event|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged ˃60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11225600|NCT02369484|BG000|Baseline|Afatinib|"Afatinib 40 mg p.o./day until tumour progression or lack of tolerability~Afatinib: 40mg p.o./ day until documented progression or unacceptable toxicity"
11225601|NCT02369484|FG000|Participant Flow|Afatinib|Afatinib 40 mg p.o./day until tumour progression or lack of tolerability
11012346|NCT01116882|BG001|Baseline|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
11012347|NCT01116882|BG002|Baseline|Total|Total of all reporting groups
11225602|NCT02369484|OG000|Outcome|Afatinib|Afatinib 40 mg p.o./day until tumour progression or lack of tolerability
11225603|NCT02369484|EG000|Reported Event|Afatinib|"Afatinib 40 mg p.o./day until tumour progression or lack of tolerability~Afatinib: 40mg p.o./ day until documented progression or unacceptable toxicity"
11012348|NCT01116882|FG000|Participant Flow|PCI at a Hospital Without On-site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
11225604|NCT02369510|BG000|Baseline|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
11225605|NCT02369510|BG001|Baseline|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
11012349|NCT01116882|FG001|Participant Flow|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
11012350|NCT01116882|OG000|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
11012351|NCT01116882|OG001|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
11012352|NCT01116882|OG000|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery.
11012353|NCT01116882|OG000|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
11012354|NCT01116882|OG001|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
11012355|NCT01116882|EG000|Reported Event|Non-Surgery-On-Site (Non-SOS)|Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.
11012356|NCT01116882|EG001|Reported Event|Surgery-On-Site (SOS)|Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
11012357|NCT01116895|BG000|Baseline|LEO 22811 0.5 mg|LEO 22811 0.5 mg: Oral solution
11012358|NCT01116895|BG001|Baseline|LEO 22811 1.5 mg|LEO 22811 1.5 mg: Oral solution
11012359|NCT01116895|BG002|Baseline|LEO 22811 3.0 mg|LEO 22811 3.0 mg: Oral solution
11012360|NCT01116895|BG003|Baseline|Placebo|Placebo: Oral solution
11012361|NCT01116895|BG004|Baseline|Total|Total of all reporting groups
11012362|NCT01116895|FG000|Participant Flow|LEO 22811 0.5 mg|LEO 22811 0.5 mg: Oral solution
11012363|NCT01116895|FG001|Participant Flow|LEO 22811 1.5 mg|LEO 22811 1.5 mg: Oral solution
11012364|NCT01116895|FG002|Participant Flow|LEO 22811 3.0 mg|LEO 22811 3.0 mg: Oral solution
11012365|NCT01116895|FG003|Participant Flow|Placebo|Placebo: Oral solution
11012366|NCT01116895|OG000|Outcome|Placebo|Placebo: Oral solution
11148035|NCT01860950|OG000|Outcome|Anodal tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.~anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder"
11148036|NCT01860950|OG001|Outcome|Anodal tDCS Plus Pain-education|"Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder.~Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder"
11148037|NCT01860950|OG002|Outcome|Cathodal tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.~cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC."
11148038|NCT01860950|OG003|Outcome|Cathodal tDCS Plus Pain-education|"Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode attached to the right shoulder and the cathode electrode was placed over the left DLPFC. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC."
11148039|NCT01860950|OG004|Outcome|Sham tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.~sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session"
11148040|NCT01860950|OG005|Outcome|Sham tDCS Plus Pain-education|"Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session"
11148041|NCT01860950|OG000|Outcome|All Participants|At the end of the laboratory session, participants were asked to indicate whether they thought they received real or sham tDCS. The base-rate for correctly guessing real versus sham was 50%.
11148042|NCT01860950|EG000|Reported Event|Anodal tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.~anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder"
11148043|NCT01860950|EG001|Reported Event|Anodal tDCS Plus Pain-education|"Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder.~Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~anodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder"
11148044|NCT01860950|EG002|Reported Event|Cathodal tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.~cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC."
11148045|NCT01860950|EG003|Reported Event|Cathodal tDCS Plus Pain-education|"Participants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode attached to the right shoulder and the cathode electrode was placed over the left DLPFC. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~cathodal tDCS: a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC."
11148046|NCT01860950|EG004|Reported Event|Sham tDCS Plus BCI|"Participants underwent Brief Cognitive intervention (BCI) during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.~sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session"
11012367|NCT01116895|OG001|Outcome|LEO 22811 0.5 mg|LEO 22811 0.5 mg: Oral solution
11012368|NCT01116895|OG002|Outcome|LEO 22811 1.5 mg|LEO 22811 1.5 mg: Oral solution
11012369|NCT01116895|OG003|Outcome|LEO 22811 3.0 mg|LEO 22811 3.0 mg: Oral solution
11012370|NCT01116895|EG000|Reported Event|Placebo|Placebo: Oral solution
11012371|NCT01116895|EG001|Reported Event|LEO 22811 0.5 mg|LEO 22811 0.5 mg: Oral solution
11012372|NCT01116895|EG002|Reported Event|LEO 22811 1.5 mg|LEO 22811 1.5 mg: Oral solution
11012373|NCT01116895|EG003|Reported Event|LEO 22811 3.0 mg|LEO 22811 3.0 mg: Oral solution
11012374|NCT01116921|BG000|Baseline|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
11012375|NCT01116921|BG001|Baseline|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
11012376|NCT01116921|BG002|Baseline|Total|Total of all reporting groups
11012377|NCT01116921|FG000|Participant Flow|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
11012378|NCT01116921|FG001|Participant Flow|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
11012379|NCT01116921|OG000|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
11012380|NCT01116921|OG001|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
11012381|NCT01116921|EG000|Reported Event|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
11012382|NCT01116921|EG001|Reported Event|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
11012383|NCT01116934|BG000|Baseline|PLS Patients|8 PLS patients (one female) from 6 families
11012384|NCT01116934|BG001|Baseline|Healthy Controls|9 healthy donors
11012385|NCT01116934|BG002|Baseline|Total|Total of all reporting groups
11012386|NCT01116934|FG000|Participant Flow|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
11225606|NCT02369510|BG002|Baseline|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
11225607|NCT02369510|BG003|Baseline|Total|Total of all reporting groups
11012387|NCT01116934|FG001|Participant Flow|Healthy Controls|9 healthy donors
11012388|NCT01116934|OG000|Outcome|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
11012389|NCT01116934|OG001|Outcome|Healthy Controls|9 healthy donors
11012390|NCT01116934|EG000|Reported Event|PLS Patients|8 PLS patients (one female) from 6 families
11012391|NCT01116934|EG001|Reported Event|Healthy Controls|9 healthy donors
11012392|NCT01116986|BG000|Baseline|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012393|NCT01116986|BG001|Baseline|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012394|NCT01116986|BG002|Baseline|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012395|NCT01116986|BG003|Baseline|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012396|NCT01116986|BG004|Baseline|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012397|NCT01116986|BG005|Baseline|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012398|NCT01116986|BG006|Baseline|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11066064|NCT01390818|OG005|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11012399|NCT01116986|BG007|Baseline|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012400|NCT01116986|BG008|Baseline|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012401|NCT01116986|BG009|Baseline|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012402|NCT01116986|BG010|Baseline|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012403|NCT01116986|BG011|Baseline|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012404|NCT01116986|BG012|Baseline|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012405|NCT01116986|BG013|Baseline|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012406|NCT01116986|BG014|Baseline|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012407|NCT01116986|BG015|Baseline|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012408|NCT01116986|BG016|Baseline|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012409|NCT01116986|BG017|Baseline|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012410|NCT01116986|BG018|Baseline|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
11012411|NCT01116986|BG019|Baseline|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
11012412|NCT01116986|BG020|Baseline|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012413|NCT01116986|BG021|Baseline|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012414|NCT01116986|BG022|Baseline|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012415|NCT01116986|BG023|Baseline|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11150192|NCT01876329|BG001|Baseline|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
11012416|NCT01116986|BG024|Baseline|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012417|NCT01116986|BG025|Baseline|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012418|NCT01116986|BG026|Baseline|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012419|NCT01116986|BG027|Baseline|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012420|NCT01116986|BG028|Baseline|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012421|NCT01116986|BG029|Baseline|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012422|NCT01116986|BG030|Baseline|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012423|NCT01116986|BG031|Baseline|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012424|NCT01116986|BG032|Baseline|Total|Total of all reporting groups
11012425|NCT01116986|FG000|Participant Flow|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012426|NCT01116986|FG001|Participant Flow|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012427|NCT01116986|FG002|Participant Flow|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012428|NCT01116986|FG003|Participant Flow|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012429|NCT01116986|FG004|Participant Flow|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012430|NCT01116986|FG005|Participant Flow|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012431|NCT01116986|FG006|Participant Flow|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012432|NCT01116986|FG007|Participant Flow|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012433|NCT01116986|FG008|Participant Flow|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012434|NCT01116986|FG009|Participant Flow|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012435|NCT01116986|FG010|Participant Flow|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012436|NCT01116986|FG011|Participant Flow|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012437|NCT01116986|FG012|Participant Flow|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012438|NCT01116986|FG013|Participant Flow|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012439|NCT01116986|FG014|Participant Flow|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012440|NCT01116986|FG015|Participant Flow|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012441|NCT01116986|FG016|Participant Flow|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012442|NCT01116986|FG017|Participant Flow|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012443|NCT01116986|FG018|Participant Flow|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
11012444|NCT01116986|FG019|Participant Flow|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
11012445|NCT01116986|FG020|Participant Flow|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012446|NCT01116986|FG021|Participant Flow|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012447|NCT01116986|FG022|Participant Flow|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012448|NCT01116986|FG023|Participant Flow|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012449|NCT01116986|FG024|Participant Flow|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012450|NCT01116986|FG025|Participant Flow|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012451|NCT01116986|FG026|Participant Flow|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012452|NCT01116986|FG027|Participant Flow|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012453|NCT01116986|FG028|Participant Flow|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012454|NCT01116986|FG029|Participant Flow|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012455|NCT01116986|FG030|Participant Flow|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
11012456|NCT01116986|FG031|Participant Flow|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
11012457|NCT01116986|OG000|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
11012458|NCT01116986|OG001|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
11012459|NCT01116986|OG002|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
11012460|NCT01116986|OG003|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
11066065|NCT01390818|OG006|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066066|NCT01390818|OG007|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066067|NCT01390818|OG008|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11012461|NCT01116986|OG004|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
11012462|NCT01116986|OG005|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
11012463|NCT01116986|OG006|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
11012464|NCT01116986|OG007|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
11012465|NCT01116986|OG008|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
11012466|NCT01116986|OG009|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
11012467|NCT01116986|OG010|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
11150193|NCT01876329|BG002|Baseline|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
11150194|NCT01876329|BG003|Baseline|Total|Total of all reporting groups
11150195|NCT01876329|FG000|Participant Flow|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
11012468|NCT01116986|OG011|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
11012469|NCT01116986|EG000|Reported Event|Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch~Participants randomized to this condition received Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch.~Before quitting: Everyone had ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day."
11012470|NCT01116986|EG001|Reported Event|Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Patch~Participants randomized to this condition received Pre-Quit Nicotine Patch.~Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
11012471|NCT01116986|EG002|Reported Event|Pre-Quit Nicotine Gum|"Pre-Quit Nicotine Gum~Participants randomized to this condition received Pre-Quit Nicotine Gum.~Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
11012472|NCT01116986|EG003|Reported Event|No Pre-Quit Nicotine Patch Nor Gum|"No Pre-Quit Nicotine Patch nor Gum~Participants randomized to this condition received neither the Pre-Quit Nicotine Patch nor the Pre-Quit Nicotine Gum."
11012473|NCT01116986|EG004|Reported Event|Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum~Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
11012474|NCT01116986|EG005|Reported Event|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum~Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
11012475|NCT01117012|BG000|Baseline|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
11012476|NCT01117012|BG001|Baseline|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
11012477|NCT01117012|BG002|Baseline|Total|Total of all reporting groups
11012478|NCT01117012|FG000|Participant Flow|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 milligram (mg) tablet orally twice daily (q12h).
11012479|NCT01117012|FG001|Participant Flow|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
11012480|NCT01117012|OG000|Outcome|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
11012481|NCT01117012|OG000|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
11012482|NCT01117012|OG001|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
11012483|NCT01117012|EG000|Reported Event|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
11012484|NCT01117051|BG000|Baseline|Placebo|placebo once daily before breakfast for up to 12 weeks
11012485|NCT01117051|BG001|Baseline|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
11012486|NCT01117051|BG002|Baseline|Total|Total of all reporting groups
11012487|NCT01117051|FG000|Participant Flow|Placebo|placebo once daily before breakfast for up to 12 weeks
11012488|NCT01117051|FG001|Participant Flow|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
11012489|NCT01117051|OG000|Outcome|Placebo|once daily before breakfast for up to 12 weeks
11012490|NCT01117051|OG001|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
11012491|NCT01117051|OG000|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
11012492|NCT01117051|EG000|Reported Event|Placebo|once daily before breakfast for up to 12 weeks
11012493|NCT01117051|EG001|Reported Event|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
11012494|NCT01117090|BG000|Baseline|Intrathecal Pump Patients|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
11012495|NCT01117090|FG000|Participant Flow|Intrathecal Pump Patients|Subjects previously implanted with an intrathecal pump who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
11012496|NCT01117090|OG000|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
11012497|NCT01117090|OG001|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
11012498|NCT01117090|OG000|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
11012499|NCT01117090|OG001|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
11012500|NCT01117090|OG000|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of normal catheter function from the physician
11012501|NCT01117090|OG001|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of catheter complication from the physician
11012502|NCT01117090|OG000|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of normal catheter function from the physician
11012503|NCT01117090|OG001|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of catheter complication from the physician
11012504|NCT01117090|EG000|Reported Event|Intrathecal Pump Patients|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
11012505|NCT01117181|BG000|Baseline|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
11012506|NCT01117181|BG001|Baseline|Placebo|matching placebo and psychosocial intervention
11012507|NCT01117181|BG002|Baseline|Total|Total of all reporting groups
11012508|NCT01117181|FG000|Participant Flow|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
11012509|NCT01117181|FG001|Participant Flow|Placebo|matching placebo and psychosocial intervention
11012510|NCT01117181|OG000|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
11012511|NCT01117181|OG001|Outcome|Placebo|Placebo and psychosocial intervention
11012512|NCT01117181|OG000|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
11012513|NCT01117181|OG001|Outcome|Placebo|matching placebo and psychosocial intervention
11012514|NCT01117181|EG000|Reported Event|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
11012515|NCT01117181|EG001|Reported Event|Placebo|matching placebo and psychosocial intervention
11012516|NCT01117311|BG000|Baseline|Entire Study Population|Includes groups randomized to have the VNB off first and the VNB on first.
11012517|NCT01117311|FG000|Participant Flow|VNB Off First, Then VNB on|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) off first for the first intervention (Mixed Meal 2), then VNB on for the second intervention (Mixed Meal 3).
11012518|NCT01117311|FG001|Participant Flow|VNB on First, Then VNB Off|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) on first for the first intervention (Mixed Meal 2), then VNB off for the second intervention (Mixed Meal 3).
11148047|NCT01860950|EG005|Reported Event|Sham tDCS Plus Pain-education|"Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.~sham tDCS: Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session"
11012519|NCT01117311|OG000|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
11012520|NCT01117311|OG001|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
11012521|NCT01117311|EG000|Reported Event|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
11012522|NCT01117311|EG001|Reported Event|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
11012523|NCT01117337|BG000|Baseline|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
11012524|NCT01117337|BG001|Baseline|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
11012525|NCT01117337|BG002|Baseline|Total|Total of all reporting groups
11012526|NCT01117337|FG000|Participant Flow|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
11012527|NCT01117337|FG001|Participant Flow|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
11012528|NCT01117337|OG000|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
11012529|NCT01117337|OG001|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
11012530|NCT01117337|EG000|Reported Event|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
11012531|NCT01117337|EG001|Reported Event|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
11012532|NCT01117350|BG000|Baseline|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
11012533|NCT01117350|BG001|Baseline|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
11012534|NCT01117350|BG002|Baseline|Total|Total of all reporting groups
11012535|NCT01117350|FG000|Participant Flow|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
11012536|NCT01117350|FG001|Participant Flow|Liraglutide (Comparative Period)/ Insulin Glargine (Extension)|"Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)~For patients included in the extension period: Insulin Glargine (dosing same as above)"
11012537|NCT01117350|OG000|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
11012538|NCT01117350|OG001|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
11012539|NCT01117350|OG000|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
11012540|NCT01117350|OG000|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
11012541|NCT01117350|EG000|Reported Event|Comparative Period: Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
11012542|NCT01117350|EG001|Reported Event|Comparative Period: Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)
11012543|NCT01117350|EG002|Reported Event|Extension Period: Insulin Glargine|"Following a treatment with liraglutide during the comparative period, those patients have received insulin glargine during the extension period.~Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days"
11012544|NCT01117428|BG000|Baseline|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions"
11012545|NCT01117428|BG001|Baseline|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, weekly - i.v. infusions"
11012546|NCT01117428|BG002|Baseline|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg, weekly - i.v. infusions"
11012547|NCT01117428|BG003|Baseline|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions"
11012548|NCT01117428|BG004|Baseline|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions"
11012549|NCT01117428|BG005|Baseline|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions"
11012550|NCT01117428|BG006|Baseline|Total|Total of all reporting groups
11012551|NCT01117428|FG000|Participant Flow|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions"
11012552|NCT01117428|FG001|Participant Flow|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-epidermal growth factor receptor (anti-EGFR) antibody refractory metastatic colorectal cancer (mCRC).~Sym004: 12 mg/kg, weekly - i.v. infusions"
11012553|NCT01117428|FG002|Participant Flow|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg, weekly - i.v. infusions"
11012554|NCT01117428|FG003|Participant Flow|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions"
11012555|NCT01117428|FG004|Participant Flow|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions"
11012556|NCT01117428|FG005|Participant Flow|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions"
11012557|NCT01117428|OG000|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions"
11012558|NCT01117428|OG001|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, weekly - i.v. infusions"
11012559|NCT01117428|OG002|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg, weekly - i.v. infusions"
11012560|NCT01117428|OG003|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions"
11012561|NCT01117428|OG004|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions"
11012562|NCT01117428|OG005|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions"
11012563|NCT01117428|OG002|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg weekly - i.v. infusions"
11012564|NCT01117428|OG005|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusion"
11012565|NCT01117428|EG000|Reported Event|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004 - 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions"
11012566|NCT01117428|EG001|Reported Event|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 12 mg/kg, weekly - i.v. infusions"
11012567|NCT01117428|EG002|Reported Event|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 9 mg/kg, weekly - i.v. infusions"
11012568|NCT01117428|EG003|Reported Event|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 12 mg/kg, once every 2 weeks - i.v. infusions"
11012569|NCT01117428|EG004|Reported Event|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 18 mg/kg, once every 2 weeks - i.v. infusions"
11012570|NCT01117428|EG005|Reported Event|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions"
11012571|NCT01117454|BG000|Baseline|Flecainide Then Placebo|"In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
11012572|NCT01117454|BG001|Baseline|Placebo Then Flecainide|"In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
11012573|NCT01117454|BG002|Baseline|Total|Total of all reporting groups
11012574|NCT01117454|FG000|Participant Flow|Flecainide Then Placebo|"In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
11012575|NCT01117454|FG001|Participant Flow|Placebo Then Flecainide|"In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
11012576|NCT01117454|OG000|Outcome|Flecainide|All participants when receiving flecainide
11012577|NCT01117454|OG001|Outcome|Placebo|All participants when receving placebo
11012578|NCT01117454|EG000|Reported Event|Flecainide|All participants when receiving flecainide
11012579|NCT01117454|EG001|Reported Event|Placebo|All participants when receving placebo
11012580|NCT01117480|BG000|Baseline|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
11012581|NCT01117480|FG000|Participant Flow|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
11012582|NCT01117480|OG000|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
11012583|NCT01117480|EG000|Reported Event|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
11012584|NCT01117623|BG000|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012585|NCT01117623|BG001|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012586|NCT01117623|BG002|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012587|NCT01117623|BG003|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012588|NCT01117623|BG004|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012589|NCT01117623|BG005|Baseline|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012590|NCT01117623|BG006|Baseline|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012591|NCT01117623|BG007|Baseline|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012592|NCT01117623|BG008|Baseline|Total|Total of all reporting groups
11066068|NCT01390818|OG009|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11012593|NCT01117623|FG000|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral co-precipitate (CP) tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012594|NCT01117623|FG001|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012595|NCT01117623|FG002|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012596|NCT01117623|FG003|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012597|NCT01117623|FG004|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012598|NCT01117623|FG005|Participant Flow|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012599|NCT01117623|FG006|Participant Flow|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012600|NCT01117623|FG007|Participant Flow|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012601|NCT01117623|OG000|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012602|NCT01117623|OG000|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012603|NCT01117623|OG001|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012604|NCT01117623|OG002|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012605|NCT01117623|OG003|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012606|NCT01117623|OG004|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012607|NCT01117623|OG005|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11148048|NCT01860989|BG000|Baseline|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
11012608|NCT01117623|OG006|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012609|NCT01117623|OG007|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012610|NCT01117623|OG000|Outcome|HCC Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012611|NCT01117623|OG001|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012612|NCT01117623|OG000|Outcome|HCC Expansion Cohort, Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012613|NCT01117623|OG001|Outcome|NSCLC Expansion Cohort, Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012614|NCT01117623|EG000|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012615|NCT01117623|EG001|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012616|NCT01117623|EG002|Reported Event|Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle. This arm includes the participants from the dose escalation cohort: Regorafenib 100 mg and the three Expansion Cohorts 'HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg', 'HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg', 'NSCLC Expansion Cohort: Regorafenib 100 mg'.
11012617|NCT01117623|EG003|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012618|NCT01117623|EG004|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
11012619|NCT01117727|BG000|Baseline|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
11012620|NCT01117727|FG000|Participant Flow|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
11012621|NCT01117727|OG000|Outcome|Pilot Testing, 0.65 Scan Rate|Pilot subject testing protocol with scan rate at 0.65 seconds per item.
11012622|NCT01117727|OG001|Outcome|Pilot Testing With Scan Rate at 2 Stdev|Pilot testing with scan rate set at twice the standard deviation of the reaction time.
11012623|NCT01117727|EG000|Reported Event|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
11012624|NCT01117766|BG000|Baseline|All Participants|Includes all participants randomized to receive pregabalin first and placebo first.
11012625|NCT01117766|FG000|Participant Flow|Pregabalin Then Placebo|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.
11012626|NCT01117766|FG001|Participant Flow|Placebo Then Pregabalin|Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
11012627|NCT01117766|OG000|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
11012628|NCT01117766|OG001|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
11012629|NCT01117766|EG000|Reported Event|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
11012630|NCT01117766|EG001|Reported Event|Placebo|Participants took placebo to match the pregabalin doses BID.
11012631|NCT01117792|BG000|Baseline|S-ICD System|Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
11012632|NCT01117792|FG000|Participant Flow|S-ICD System|Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
11012633|NCT01117792|OG000|Outcome|S-ICD System|Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
11012634|NCT01117792|EG000|Reported Event|S-ICD System|Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.
11012635|NCT01117857|BG000|Baseline|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
11012636|NCT01117857|FG000|Participant Flow|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
11012637|NCT01117857|OG000|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
11012638|NCT01117857|EG000|Reported Event|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
11012639|NCT01117870|BG000|Baseline|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
11012640|NCT01117870|BG001|Baseline|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
11012641|NCT01117870|BG002|Baseline|Total|Total of all reporting groups
11012642|NCT01117870|FG000|Participant Flow|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
11012643|NCT01117870|FG001|Participant Flow|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
11012644|NCT01117870|OG000|Outcome|Eligible Patients|Patients meeting eligibility criteria
11148049|NCT01860989|FG000|Participant Flow|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
11148050|NCT01860989|OG000|Outcome|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
11012645|NCT01117870|OG000|Outcome|Lost to Follow-up Patients|Patients who were lost to follow-up at 3 months
11012646|NCT01117870|OG000|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.~The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials."
11012647|NCT01117870|OG001|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius~The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials."
11012648|NCT01117870|OG000|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
11012649|NCT01117870|OG001|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
11012650|NCT01117870|EG000|Reported Event|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
11012651|NCT01117870|EG001|Reported Event|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
11012652|NCT01117948|BG000|Baseline|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
11012653|NCT01117948|BG001|Baseline|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
11012654|NCT01117948|BG002|Baseline|Total|Total of all reporting groups
11012655|NCT01117948|FG000|Participant Flow|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
11012656|NCT01117948|FG001|Participant Flow|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
11012657|NCT01117948|OG000|Outcome|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
11012658|NCT01117948|OG001|Outcome|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
11012659|NCT01117948|EG000|Reported Event|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
11012660|NCT01117948|EG001|Reported Event|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
11012661|NCT01117987|BG000|Baseline|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
11012662|NCT01117987|BG001|Baseline|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
11012663|NCT01117987|BG002|Baseline|Total|Total of all reporting groups
11012664|NCT01117987|FG000|Participant Flow|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
11012665|NCT01117987|FG001|Participant Flow|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
11012666|NCT01117987|OG000|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
11012667|NCT01117987|OG001|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
11012668|NCT01117987|EG000|Reported Event|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
11012669|NCT01117987|EG001|Reported Event|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
11012670|NCT01118052|BG000|Baseline|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
11012671|NCT01118052|FG000|Participant Flow|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
11012672|NCT01118052|OG000|Outcome|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
11012673|NCT01118052|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
11012674|NCT01118052|OG001|Outcome|Grade 1 (CTCAE v 4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
11012675|NCT01118052|OG002|Outcome|Grade 2 (CTCAE v 4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
11012676|NCT01118052|OG003|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
11012677|NCT01118052|OG004|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
11012678|NCT01118052|OG005|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
11012679|NCT01118052|EG000|Reported Event|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
11012680|NCT01118091|BG000|Baseline|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
11066069|NCT01390818|OG003|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11148051|NCT01860989|EG000|Reported Event|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
11012681|NCT01118091|BG001|Baseline|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
11012682|NCT01118091|BG002|Baseline|Total|Total of all reporting groups
11012683|NCT01118091|FG000|Participant Flow|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
11012684|NCT01118091|FG001|Participant Flow|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
11012685|NCT01118091|OG000|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
11012686|NCT01118091|OG001|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
11012687|NCT01118091|EG000|Reported Event|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
11012688|NCT01118091|EG001|Reported Event|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
11012689|NCT01118117|BG000|Baseline|Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
11012690|NCT01118117|BG001|Baseline|Long Length (150mm) Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
11012691|NCT01118117|BG002|Baseline|Total|Total of all reporting groups
11012692|NCT01118117|FG000|Participant Flow|Misago™ Self-Expanding Stent System|Subjects received treatment with the Misago™ Self-Expanding Stent
11012693|NCT01118117|FG001|Participant Flow|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
11012694|NCT01118117|OG000|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
11012695|NCT01118117|OG001|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
11012696|NCT01118117|EG000|Reported Event|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
11012697|NCT01118117|EG001|Reported Event|Long Length Stent Sub-study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
11012698|NCT01118143|BG000|Baseline|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
11012699|NCT01118143|BG001|Baseline|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
11012700|NCT01118143|BG002|Baseline|Total|Total of all reporting groups
11012701|NCT01118143|FG000|Participant Flow|Experiment: Communication Adapted to Health Literacy Level|Participants in the experimental group got individualized communication regarding their oral health. The communication was adapted to the measured Health Literacy level of each participant. Health Literacy communication theory was utilized in order to adapt the communication to the participants Health literacy level. Two-way communication with use of models, illustrative pictures and teach-back method was emphasized. Up to 30 minutes was available for this intervention conversation.
11012702|NCT01118143|FG001|Participant Flow|Control: Short Standard Information|Participants in the control group got short standard information after the clinical measurement, as usual in general dental clinical practice. E.g. If there was gingival bleeding, participants got a message that their gums were bleeding and that dental floss was recommended.
11012703|NCT01118143|OG000|Outcome|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
11012704|NCT01118143|OG001|Outcome|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
11012705|NCT01118143|OG000|Outcome|Individualized Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
11012706|NCT01118143|OG001|Outcome|Ordinary Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
11012707|NCT01118143|EG000|Reported Event|Individualized Oral Health Instruction|The oral health instruction is individualized according to the patients oral health literacy level
11012708|NCT01118143|EG001|Reported Event|Control|The oral health instruction is according to standard clinical practice
11012709|NCT01118221|BG000|Baseline|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
11012710|NCT01118221|BG001|Baseline|Control|no structured exercise
11012711|NCT01118221|BG002|Baseline|Total|Total of all reporting groups
11012712|NCT01118221|FG000|Participant Flow|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
11012713|NCT01118221|FG001|Participant Flow|Control|no structured exercise
11012714|NCT01118221|OG000|Outcome|Arm 1|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
11012715|NCT01118221|OG001|Outcome|Arm 2|no structured exercise
11012716|NCT01118221|OG000|Outcome|Before Exercise Testing|Plasma isoprostanes before exercise test.
11012717|NCT01118221|OG001|Outcome|After Exercise Testing|Plasma isoprostanes after exercise testing.
11012718|NCT01118221|OG000|Outcome|Rehabilitation Group|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
11012719|NCT01118221|OG001|Outcome|Control Group|no structured exercise
11012720|NCT01118221|EG000|Reported Event|Arm 1|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
11012721|NCT01118221|EG001|Reported Event|Arm 2|no structured exercise
11012722|NCT01118273|BG000|Baseline|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
11012723|NCT01118273|BG001|Baseline|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
11012724|NCT01118273|BG002|Baseline|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
11012725|NCT01118273|BG003|Baseline|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
11012726|NCT01118273|BG004|Baseline|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
11012727|NCT01118273|BG005|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
11012728|NCT01118273|BG006|Baseline|Total|Total of all reporting groups
11012729|NCT01118273|FG000|Participant Flow|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
11012730|NCT01118273|FG001|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
11012731|NCT01118273|FG002|Participant Flow|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
11012732|NCT01118273|FG003|Participant Flow|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
11012733|NCT01118273|FG004|Participant Flow|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
11148052|NCT01861002|BG000|Baseline|Dose Level 1 75 mg/m2/Day|This arm is comprised of the AML and ALL participants that completed Dose Level 1 75 mg/m2/day
11148053|NCT01861002|FG000|Participant Flow|75 mg/m2/Day Azacytidine|"Azacytidine (Dose Level @ 75 mg/m2/day),all patients will start at Dose Level 1. If 2 DLTs are observed within the first 6 patients enrolled, dose will be reduced to Dose Level 0 @ 50 mg/m2/day~Fludarabine 30 mg/m2/dose~Cytarabine 2000 mg/m2/dose~Intrathecal (IT) Cytarabine"
11148054|NCT01861002|OG000|Outcome|Dose 75 mg/m2/Day Azacytidine Diagnosed With AML|Evaluable Participants who received azacytidine @ 75 mg/m2/day (Dose Level 1)
11148055|NCT01861002|OG001|Outcome|Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL|Evaluable ALL participants who received azacytidine @ 75 mg/m2/day (Dose Level 1)
11150196|NCT01876329|FG001|Participant Flow|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
11012734|NCT01118273|FG005|Participant Flow|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
11012735|NCT01118273|OG000|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
11150197|NCT01876329|FG002|Participant Flow|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
11150198|NCT01876329|OG000|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
11012736|NCT01118273|OG001|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
11012737|NCT01118273|OG002|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
11012738|NCT01118273|OG003|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
11012739|NCT01118273|OG004|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
11012740|NCT01118273|OG005|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
11012741|NCT01118273|EG000|Reported Event|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
11012742|NCT01118273|EG001|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
11012743|NCT01118273|EG002|Reported Event|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
11012744|NCT01118273|EG003|Reported Event|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
11012745|NCT01118273|EG004|Reported Event|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
11012746|NCT01118273|EG005|Reported Event|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
11012747|NCT01118299|BG000|Baseline|Device|"AMPLATZER Cardiac Plug~AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device"
11012748|NCT01118299|BG001|Baseline|Optimal Medical Therapy (Control)|"Warfarin Dabigatran~AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device"
11012749|NCT01118299|BG002|Baseline|Total|Total of all reporting groups
11012750|NCT01118299|FG000|Participant Flow|Device|"AMPLATZER Cardiac Plug~AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device"
11012751|NCT01118299|FG001|Participant Flow|Optimal Medical Therapy (Control)|"Warfarin Dabigatran~AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device"
11012752|NCT01118299|OG000|Outcome|Device Arm|Subjects who received the ACP device
11012753|NCT01118299|EG000|Reported Event|Device|"AMPLATZER Cardiac Plug~AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device"
11012754|NCT01118299|EG001|Reported Event|Optimal Medical Therapy (Control)|"Warfarin Dabigatran~AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device"
11012755|NCT01118312|BG000|Baseline|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
11012756|NCT01118312|BG001|Baseline|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
11012757|NCT01118312|BG002|Baseline|Total|Total of all reporting groups
11012758|NCT01118312|FG000|Participant Flow|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
11012759|NCT01118312|FG001|Participant Flow|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
11012760|NCT01118312|OG000|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
11012761|NCT01118312|OG001|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
11012762|NCT01118312|EG000|Reported Event|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
11012763|NCT01118312|EG001|Reported Event|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
11012764|NCT01118325|BG000|Baseline|AZD6140 45 mg bd|AZD6140 45 mg twice daily
11012765|NCT01118325|BG001|Baseline|AZD6140 90 mg bd|AZD6140 90 mg twice daily
11012766|NCT01118325|BG002|Baseline|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
11012767|NCT01118325|BG003|Baseline|Total|Total of all reporting groups
11012768|NCT01118325|FG000|Participant Flow|AZD6140 45 mg bd|AZD6140 45 mg twice daily
11012769|NCT01118325|FG001|Participant Flow|AZD6140 90 mg bd|AZD6140 90 mg twice daily
11012770|NCT01118325|FG002|Participant Flow|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
11012771|NCT01118325|OG000|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
11012772|NCT01118325|OG001|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
11012773|NCT01118325|OG002|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
11012774|NCT01118325|OG000|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
11012775|NCT01118325|OG001|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
11012776|NCT01118325|OG000|Outcome|Arm 1 - AZD6140 45 mg bd|AZD6140 45 mg twice daily
11012777|NCT01118325|OG000|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
11012778|NCT01118325|OG001|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
11012779|NCT01118325|OG002|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
11012780|NCT01118325|OG003|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
11012781|NCT01118325|OG001|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
11012782|NCT01118325|OG003|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
11012783|NCT01118325|OG001|Outcome|AZD6140 45mg bd in Non-Jpanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
11012784|NCT01118325|OG003|Outcome|AZD6140 90 mg bd in Non-Jpanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
11012785|NCT01118325|OG000|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese Patients
11012786|NCT01118325|OG002|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese Patients
11012787|NCT01118325|EG000|Reported Event|AZD6140 45 mg bd|AZD6140 45 mg twice daily
11012788|NCT01118325|EG001|Reported Event|AZD6140 90 mg bd|AZD6140 90 mg twice daily
11012789|NCT01118325|EG002|Reported Event|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
11012790|NCT01118338|BG000|Baseline|Redesigned Purevision Contact Lens|"Redesigned Bausch & Lomb PureVision contact lens~Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month."
11012791|NCT01118338|BG001|Baseline|PureVision Contact Lens|"Bausch & Lomb PureVision contact lens~PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month."
11012792|NCT01118338|BG002|Baseline|Total|Total of all reporting groups
11012793|NCT01118338|FG000|Participant Flow|Redesigned Purevision Contact Lens|"Redesigned Bausch & Lomb PureVision contact lens~Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month."
11012794|NCT01118338|FG001|Participant Flow|PureVision Contact Lens|"Bausch & Lomb PureVision contact lens~PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month."
11012795|NCT01118338|OG000|Outcome|Redesigned Purevision Contact Lens|"Redesigned Bausch & Lomb PureVision contact lens~Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month."
11012796|NCT01118338|OG001|Outcome|PureVision Contact Lens|"Bausch & Lomb PureVision contact lens~PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month."
11012797|NCT01118338|EG000|Reported Event|Redesigned Purevision Contact Lens|"Redesigned Bausch & Lomb PureVision contact lens~Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month."
11012798|NCT01118338|EG001|Reported Event|PureVision Contact Lens|"Bausch & Lomb PureVision contact lens~PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month."
11012799|NCT01118351|BG000|Baseline|Arm I|"Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given orally~immunohistochemistry staining method: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~light microscopy: Correlative studies~laboratory biomarker analysis: Correlative studies"
11012800|NCT01118351|FG000|Participant Flow|Arm I|"Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given orally~immunohistochemistry staining method: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~light microscopy: Correlative studies~laboratory biomarker analysis: Correlative studies"
11012801|NCT01118351|OG000|Outcome|Arm I|"Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given orally~immunohistochemistry staining method: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~light microscopy: Correlative studies~laboratory biomarker analysis: Correlative studies"
11012802|NCT01118351|EG000|Reported Event|Arm I|"Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given orally~immunohistochemistry staining method: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~light microscopy: Correlative studies~laboratory biomarker analysis: Correlative studies"
11012803|NCT01118377|BG000|Baseline|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
11012804|NCT01118377|FG000|Participant Flow|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
11012805|NCT01118377|OG000|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
11012806|NCT01118377|EG000|Reported Event|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
11012807|NCT01118455|BG000|Baseline|Vagus Nerve Stimulation (VNS) Therapy - ITT Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.~The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
11012808|NCT01118455|BG001|Baseline|Anti-Epileptic Drug (AED) - ITT Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.~The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
11012809|NCT01118455|BG002|Baseline|Total|Total of all reporting groups
11150199|NCT01876329|OG001|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
11012810|NCT01118455|FG000|Participant Flow|Vagus Nerve Stimulation (VNS) - ITT Population|Vagus Nerve Stimulation (VNS) Therapy
11012811|NCT01118455|FG001|Participant Flow|Anti-Epileptic Drug (AED) - ITT Population|Anti-epileptic drug therapy
11012812|NCT01118455|OG000|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
11012813|NCT01118455|OG001|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
11012814|NCT01118455|OG002|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
11012815|NCT01118455|OG003|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
11012816|NCT01118455|OG000|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
11012817|NCT01118455|OG001|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
11012818|NCT01118455|OG002|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
11012819|NCT01118455|OG003|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
11012820|NCT01118455|OG000|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
11012821|NCT01118455|OG001|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
11012822|NCT01118455|EG000|Reported Event|Vagus Nerve Stimulation (VNS) Therapy - Safety Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.~All subjects were considered evaluable for tolerability and safety after implantation of the VNS Therapy System.~NOTE: Number of participants analyzed in VNS safety population includes one patient explanted that did not receive stimulation and was therefore excluded from ITT population."
11012823|NCT01118455|EG001|Reported Event|Anti-Epileptic Drug (AED) - Safety Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.~All subjects were considered evaluable for tolerability and safety after initiation of adjunctive AED treatment."
11012824|NCT01118520|BG000|Baseline|Perindopril|10mgs orally daily for the duration of the trial
11012825|NCT01118520|BG001|Baseline|Amlodipine|5 mgs taken orally daily for the duration of the trial
11012826|NCT01118520|BG002|Baseline|Placebo|one daily
11012827|NCT01118520|BG003|Baseline|Total|Total of all reporting groups
11012828|NCT01118520|FG000|Participant Flow|Perindopril|10mgs orally daily for the duration of the trial
11012829|NCT01118520|FG001|Participant Flow|Amlodipine|5 mgs taken orally daily for the duration of the trial
11012830|NCT01118520|FG002|Participant Flow|Placebo|one daily
11012831|NCT01118520|OG000|Outcome|Perindopril|10mgs orally daily for the duration of the trial
11012832|NCT01118520|OG001|Outcome|Amlodipine|5 mgs taken orally daily for the duration of the trial
11012833|NCT01118520|OG002|Outcome|Placebo|one daily
11012834|NCT01118520|EG000|Reported Event|Perindopril|10mgs orally daily for the duration of the trial
11012835|NCT01118520|EG001|Reported Event|Amlodipine|5 mgs taken orally daily for the duration of the trial
11012836|NCT01118520|EG002|Reported Event|Placebo|one daily
11012837|NCT01118624|BG000|Baseline|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
11012838|NCT01118624|FG000|Participant Flow|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
11012839|NCT01118624|OG000|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
11012840|NCT01118624|EG000|Reported Event|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
11066070|NCT01390818|OG004|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066071|NCT01390818|OG005|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
11066072|NCT01390818|OG006|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066073|NCT01390818|OG007|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066074|NCT01390818|OG008|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066075|NCT01390818|OG009|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066076|NCT01390818|OG000|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11150200|NCT01876329|OG002|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
11150201|NCT01876329|EG000|Reported Event|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
11012841|NCT01118663|BG000|Baseline|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
11012842|NCT01118663|BG001|Baseline|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
11012843|NCT01118663|BG002|Baseline|Total|Total of all reporting groups
11012844|NCT01118663|FG000|Participant Flow|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
11012845|NCT01118663|FG001|Participant Flow|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
11012846|NCT01118663|OG000|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
11012847|NCT01118663|OG001|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
11012848|NCT01118663|EG000|Reported Event|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
11012849|NCT01118663|EG001|Reported Event|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
11012850|NCT01118715|BG000|Baseline|Compression Glove|"Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal.~Compression glove: A compression glove worn during recovery from distal radius fracture"
11012851|NCT01118715|BG001|Baseline|Control|Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.
11012852|NCT01118715|BG002|Baseline|Total|Total of all reporting groups
11012853|NCT01118715|FG000|Participant Flow|Compression Glove|"Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal.~Compression glove: A compression glove worn during recovery from distal radius fracture"
11012854|NCT01118715|FG001|Participant Flow|Control|Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.
11012855|NCT01118715|OG000|Outcome|2 Weeks|Count of patients with a new CTS or CRPS diagnosis at 2 weeks post-surgery.
11012856|NCT01118715|OG001|Outcome|5 Weeks|Count of patients with a new CTS or CRPS diagnosis at 5 weeks post-surgery.
11012857|NCT01118715|OG002|Outcome|12 Weeks|Count of patients with a new CTS or CRPS diagnosis at 12 weeks post-surgery.
11012858|NCT01118715|OG003|Outcome|24 Weeks|Count of patients with a new CTS or CRPS diagnosis at 24 weeks post-surgery.
11012859|NCT01118715|OG000|Outcome|2 Weeks|Wrist or finger circumference measured 2 weeks after surgery.
11012860|NCT01118715|OG001|Outcome|5 Weeks|Wrist or finger circumference measured 5 weeks after surgery.
11012861|NCT01118715|OG002|Outcome|12 Weeks|Wrist or finger circumference measured 12 weeks after surgery.
11012862|NCT01118715|OG003|Outcome|24 Weeks|Wrist or finger circumference measured 24 weeks after surgery.
11012863|NCT01118715|OG000|Outcome|2 Weeks|Count of participants with full flexion/extension at 2 weeks
11150202|NCT01876329|EG001|Reported Event|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
11150203|NCT01876329|EG002|Reported Event|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
11012864|NCT01118715|OG001|Outcome|5 Weeks|Count of participants with full flexion/extension at 5 weeks
11012865|NCT01118715|OG002|Outcome|12 Weeks|Count of participants with full flexion/extension at 12 weeks
11012866|NCT01118715|OG003|Outcome|24 Weeks|Count of participants with full flexion/extension at 24 weeks
11012867|NCT01118715|OG000|Outcome|5 Weeks|Grip strength measured 5 weeks after surgery
11012868|NCT01118715|OG001|Outcome|12 Weeks|Grip strength measured 12 weeks after surgery
11012869|NCT01118715|OG002|Outcome|24 Weeks|Grip strength measured 24 weeks after surgery
11012870|NCT01118715|OG000|Outcome|2 Weeks|DASH score measured 2 weeks after surgery
11012871|NCT01118715|OG001|Outcome|5 Weeks|DASH score measured 5 weeks after surgery
11012872|NCT01118715|OG002|Outcome|12 Weeks|DASH score measured 12 weeks after surgery
11012873|NCT01118715|OG003|Outcome|24 Weeks|DASH score measured 24 weeks after surgery
11012874|NCT01118715|OG000|Outcome|2 Weeks|Level of pain reported 2 weeks after surgery
11012875|NCT01118715|OG001|Outcome|5 Weeks|Level of pain reported 5 weeks after surgery
11012876|NCT01118715|OG002|Outcome|12 Weeks|Level of pain reported 12 weeks after surgery
11012877|NCT01118715|OG003|Outcome|24 Weeks|Level of pain reported 24 weeks after surgery
11012878|NCT01118715|EG000|Reported Event|Compression Glove|"Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal.~Compression glove: A compression glove worn during recovery from distal radius fracture"
11012879|NCT01118715|EG001|Reported Event|Control|Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.
11012880|NCT01118728|BG000|Baseline|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
11012881|NCT01118728|FG000|Participant Flow|Sarilumab|Sarilumab 150 mg subcutaneous (SC) injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
11012882|NCT01118728|OG000|Outcome|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
11012883|NCT01118728|EG000|Reported Event|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
11012884|NCT01118741|BG000|Baseline|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
11012885|NCT01118741|BG001|Baseline|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
11012886|NCT01118741|BG002|Baseline|Total|Total of all reporting groups
11012887|NCT01118741|FG000|Participant Flow|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
11012888|NCT01118741|FG001|Participant Flow|Disulfiram High Dose 500mg Dose|After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
11012889|NCT01118741|OG000|Outcome|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
11012890|NCT01118741|OG001|Outcome|Disulfiram High Dose 500mg Dose|
11012891|NCT01118741|OG000|Outcome|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
11012892|NCT01118741|OG001|Outcome|Disulfiram High Dose 500mg Dose|After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
11012893|NCT01118741|EG000|Reported Event|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
11012894|NCT01118741|EG001|Reported Event|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
11012895|NCT01118780|BG000|Baseline|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
11012896|NCT01118780|BG001|Baseline|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
11012897|NCT01118780|BG002|Baseline|Total|Total of all reporting groups
11012898|NCT01118780|FG000|Participant Flow|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
11150204|NCT01876368|BG000|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
11012899|NCT01118780|FG001|Participant Flow|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
11012900|NCT01118780|OG000|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
11012901|NCT01118780|OG001|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
11012902|NCT01118780|OG000|Outcome|Duloxetine 30 mg Then Placebo|Participants, whose final dose during the treatment period was duloxetine 60 mg, were administered a 30-mg duloxetine capsule orally, once daily for 1 week followed by a placebo capsule orally, once daily for 1 week, during the 2-week taper period.
11012903|NCT01118780|OG001|Outcome|Duloxetine 60 mg Then 30 mg|Participants, whose final dose during the treatment period was 90 mg or 120 mg duloxetine, were administered duloxetine 60 mg (two 30-mg duloxetine capsules) orally, once daily for 1 week followed by a 30-mg duloxetine capsule orally, once daily for 1 week, during the 2-week taper period.
11012904|NCT01118780|OG002|Outcome|Placebo|Participants, whose final dose during the treatment period was either placebo or duloxetine 30 mg, were administered a placebo capsule orally, once daily for 2 weeks, during the 2-week taper period.
11012905|NCT01118780|EG000|Reported Event|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
11012906|NCT01118780|EG001|Reported Event|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
11012907|NCT01118845|BG000|Baseline|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
11012908|NCT01118845|FG000|Participant Flow|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
11012909|NCT01118845|OG000|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
11012910|NCT01118845|EG000|Reported Event|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
11012911|NCT01118949|BG000|Baseline|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
11012912|NCT01118949|FG000|Participant Flow|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
11012913|NCT01118949|OG000|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
11012914|NCT01118949|EG000|Reported Event|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
11150205|NCT01876368|BG001|Baseline|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
11150206|NCT01876368|BG002|Baseline|Total|Total of all reporting groups
11012915|NCT01118962|BG000|Baseline|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
11012916|NCT01118962|FG000|Participant Flow|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
11012917|NCT01118962|OG000|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
11012918|NCT01118962|EG000|Reported Event|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
11012919|NCT01118975|BG000|Baseline|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
11012920|NCT01118975|BG001|Baseline|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
11012921|NCT01118975|BG002|Baseline|Total|Total of all reporting groups
11012922|NCT01118975|FG000|Participant Flow|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
11012923|NCT01118975|FG001|Participant Flow|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
11012924|NCT01118975|OG000|Outcome|Pilot Phase|The pilot phase consisted of an escalating dose design. Three patients received lapatinib 1,250 mg daily plus 300 mg vorinistat 4 days on then 3 days off. This dose was tolerated so six more patients recieved lapatinib 1,250 mg daily plus 400 mg vorinistat 4 days on 3 days off.
11012925|NCT01118975|OG000|Outcome|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days off
11012926|NCT01118975|EG000|Reported Event|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
11012927|NCT01118975|EG001|Reported Event|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
11012928|NCT01118988|BG000|Baseline|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
11012929|NCT01118988|BG001|Baseline|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
11012930|NCT01118988|BG002|Baseline|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
11012931|NCT01118988|BG003|Baseline|Total|Total of all reporting groups
11012932|NCT01118988|FG000|Participant Flow|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
11012933|NCT01118988|FG001|Participant Flow|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
11012934|NCT01118988|FG002|Participant Flow|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
11012935|NCT01118988|OG000|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
11012936|NCT01118988|OG001|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
11150207|NCT01876368|FG000|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
11148056|NCT01861002|OG000|Outcome|Dose 75 mg/m2/Day for AML Patients|"Participants with Acute Myeloid Leukemia (AML) who are evaluable for response.~A patient will be considered evaluable for response if: (1) the patient is eligible; (2) the patient receives all or part of protocol therapy; and (3) the patient is under follow-up for a sufficient period to evaluate the disease at the end of the course 2 or meets the definition of progressive disease. A patient who dies as a result of toxicity after receiving all or part of protocol therapy will be considered a non-responder.~Intervention:~Azacytidine (Dose Level 1 @ 75 mg/m^2/day)~Fludarabine 30 mg/m^2/dose~Cytarabine 2000 mg/m^2/dose~Intrathecal (IT) Cytarabine"
11148057|NCT01861002|OG001|Outcome|Dose 75 mg/m2/Dose Azacytidine for ALL Patients|"Participants with Acute Lymphoblastic Leukemia (ALL) who are evaluable for response.~A patient will be considered evaluable for response if: (1) the patient is eligible; (2) the patient receives all or part of protocol therapy; and (3) the patient is under follow-up for a sufficient period to evaluate the disease at the end of the course 2 or meets the definition of progressive disease. A patient who dies as a result of toxicity after receiving all or part of protocol therapy will be considered a non-responder.~Intervention:~Azacytidine (Dose Level 1 @ 75 mg/m^2/day)~Fludarabine 30 mg/m^2/dose~Cytarabine 2000 mg/m^2/dose~Intrathecal (IT) Methotrexate"
11148058|NCT01861002|EG000|Reported Event|AML Cohort: 75 mg/m2/Day|Any patients in the AML arm who are evaluable for toxicity. Any patient who experiences a DLT after receiving at least one dose of AZA on study will be considered evaluable for toxicity of AZA. Patients who do not experience a DLT must receive at least 80% of the prescribed course of AZA in the first cycle (i.e., must receive at least 4 of the planned 5 doses of AZA between days 1 to 5) to be evaluable for toxicity of AZA. Patients not evaluable for toxicity of AZA will be replaced.
11148059|NCT01861002|EG001|Reported Event|ALL Cohort: 75 mg/m2/Day|Any patients in the ALL arm who are evaluable for toxicity. Any patient who experiences a DLT after receiving at least one dose of AZA on study will be considered evaluable for toxicity of AZA. Patients who do not experience a DLT must receive at least 80% of the prescribed course of AZA in the first cycle (i.e., must receive at least 4 of the planned 5 doses of AZA between days 1 to 5) to be evaluable for toxicity of AZA. Patients not evaluable for toxicity of AZA will be replaced.
11148060|NCT01861028|BG000|Baseline|iTotal CR TKR|A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
11148061|NCT01861028|FG000|Participant Flow|iTotal CR TKR|A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
11148062|NCT01861028|OG000|Outcome|Phase I|A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
11148063|NCT01861028|OG000|Outcome|Enrolled Subjects|A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
11148064|NCT01861028|EG000|Reported Event|Enrolled Subjects|A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
11148065|NCT01861054|BG000|Baseline|ER+ and/or PR+/ HER-2 -|Patients of Group A (estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+)/human epidermal growth factor receptor-2 negative (HER-2-)) were given Reparixin 1000 mg (two 500 mg tablets) for 21 consecutive days. Reparixin was administered orally, every six to eight hours t.i.d. preferably with food. However, if the patient was unable to eat, reparixin could still be administered. Reparixin was administered with about 250 mL water and a light meal or snack
11148066|NCT01861054|BG001|Baseline|ER-/PR-/HER-2-|Patients of Group B (estrogen receptor negative (ER-)/progesterone receptor negative (PR-)/HER-2-) were given Reparixin 1000 mg (two 500 mg tablets) for 21 consecutive days. Reparixin was administered orally, every six to eight hours t.i.d. preferably with food. However, if the patient was unable to eat, reparixin could still be administered. Reparixin was administered with about 250 mL water and a light meal or snack
11148067|NCT01861054|BG002|Baseline|Total|Total of all reporting groups
11148068|NCT01861054|FG000|Participant Flow|ER+ and/or PR+/ HER-2 -|Patients of Group A (estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+)/human epidermal growth factor receptor-2 negative (HER-2-)) were given Reparixin 1000 mg (two 500 mg tablets) for 21 consecutive days. Reparixin was administered orally, every six to eight hours t.i.d. preferably with food. However, if the patient was unable to eat, reparixin could still be administered. Reparixin was administered with about 250 mL water and a light meal or snack.
11148069|NCT01861054|FG001|Participant Flow|ER-/PR-/HER-2-|Patients of Group B (estrogen receptor negative (ER-)/progesterone receptor negative (PR-)/HER-2-) were given Reparixin 1000 mg (two 500 mg tablets) for 21 consecutive days. Reparixin was administered orally, every six to eight hours t.i.d. preferably with food. However, if the patient was unable to eat, reparixin could still be administered. Reparixin was administered with about 250 mL water and a light meal or snack.
11150208|NCT01876368|FG001|Participant Flow|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
11148070|NCT01861054|OG000|Outcome|ER+ and/or PR+/ HER-2 -|Patients of Group A (estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+)/human epidermal growth factor receptor-2 negative (HER-2-)) were given Reparixin 1000 mg (two 500 mg tablets) for 21 consecutive days. Reparixin was administered orally, every six to eight hours t.i.d. preferably with food. However, if the patient was unable to eat, reparixin could still be administered. Reparixin was administered with about 250 mL water and a light meal or snack
11148071|NCT01861054|OG001|Outcome|ER-/PR-/HER-2-|Patients of Group B (estrogen receptor negative (ER-)/progesterone receptor negative (PR-)/HER-2-) were given Reparixin 1000 mg (two 500 mg tablets) for 21 consecutive days. Reparixin was administered orally, every six to eight hours t.i.d. preferably with food. However, if the patient was unable to eat, reparixin could still be administered. Reparixin was administered with about 250 mL water and a light meal or snack
11148072|NCT01861054|OG000|Outcome|Treated Patients - Total|"Patients eligible were treated with Reparixin as add-in monotherapy~Reparixin: 1000 mg Oral Reparixin t.i.d. for 21 consecutive days prior to surgery"
11148073|NCT01861054|OG000|Outcome|Treated Patients - Total|"Patients eligible will be treated with Reparixin as add-in monotherapy~Reparixin: 1000 mg Oral Reparixin t.i.d. for 21 consecutive days prior to surgery"
11148074|NCT01861054|OG000|Outcome|ER+ and/or PR+/ HER-2 -|Patients of Group A (estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+)/human epidermal growth factor receptor-2 negative (HER-2-)) were given Reparixin 1000 mg (two 500 mg tablets) for 21 consecutive days. Reparixin was administered orally, every six to eight hours t.i.d. preferably with food. However, if the patient was unable to eat, reparixin could still be administered. Reparixin was administered with about 250 mL water and a light meal or snack.
11148075|NCT01861054|OG001|Outcome|ER-/PR-/HER-2-|Patients of Group B (estrogen receptor negative (ER-)/progesterone receptor negative (PR-)/HER-2-) were given Reparixin 1000 mg (two 500 mg tablets) for 21 consecutive days. Reparixin was administered orally, every six to eight hours t.i.d. preferably with food. However, if the patient was unable to eat, reparixin could still be administered. Reparixin was administered with about 250 mL water and a light meal or snack.
11148076|NCT01861054|EG000|Reported Event|Total|This represents the total safety population of 20 patients
11148077|NCT01861301|BG000|Baseline|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
11148078|NCT01861301|FG000|Participant Flow|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
11148079|NCT01861301|OG000|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
11148080|NCT01861301|OG000|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
11148081|NCT01861301|EG000|Reported Event|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
11148082|NCT01861457|BG000|Baseline|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.~Nozin Nasal Sanitizer"
11148083|NCT01861457|BG001|Baseline|Saline Placebo|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.~Placebo"
11148084|NCT01861457|BG002|Baseline|Total|Total of all reporting groups
11148085|NCT01861457|FG000|Participant Flow|Nozin® Nasal Sanitizer®|Participants undergo three nasal vestibular applications of the alcohol-based antiseptic using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
11148086|NCT01861457|FG001|Participant Flow|Phosphate-buffered Saline (PBS) Placebo|Participants undergo three nasal vestibular applications of the PBS placebo using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
11148087|NCT01861457|OG000|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
11148088|NCT01861457|OG001|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
11148089|NCT01861457|EG000|Reported Event|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril every four hours~Nozin Nasal Sanitizer"
11148090|NCT01861457|EG001|Reported Event|Sham|"Apply 4 rotations of swab to each nostril every four hours ...~Sham"
11148091|NCT01861522|BG000|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
11148092|NCT01861522|BG001|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
11148093|NCT01861522|BG002|Baseline|Total|Total of all reporting groups
11148094|NCT01861522|FG000|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
11148095|NCT01861522|FG001|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
11148096|NCT01861522|OG000|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
11148097|NCT01861522|OG001|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
11148098|NCT01861522|EG000|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
11148099|NCT01861522|EG001|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
11148100|NCT01861574|BG000|Baseline|Both Real TMS|Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
11148101|NCT01861574|BG001|Baseline|Sham Then Real TMS|Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
11148102|NCT01861574|BG002|Baseline|Real Then Sham TMS|Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
11148103|NCT01861574|BG003|Baseline|Both Sham TMS|Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
11148104|NCT01861574|BG004|Baseline|Total|Total of all reporting groups
11148105|NCT01861574|FG000|Participant Flow|Both Real TMS|Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
11148106|NCT01861574|FG001|Participant Flow|Sham Then Real TMS|Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
11148107|NCT01861574|FG002|Participant Flow|Real Then Sham TMS|Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
11148108|NCT01861574|FG003|Participant Flow|Both Sham TMS|Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
11148109|NCT01861574|OG000|Outcome|Both Real TMS|Participants in the Both Real TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Real TMS 4 hours after surgery.
11148110|NCT01861574|OG001|Outcome|Sham Then Real TMS|Participants in the Sham then Real TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and 20 minutes of Real TMS 4 hours after surgery.
11148111|NCT01861574|OG002|Outcome|Real Then Sham TMS|Participants in the Real then Sham TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then 20 minutes of Sham TMS 4 hours after surgery.
11148112|NCT01861574|OG003|Outcome|Both Sham TMS|Participants in the Both Sham TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Sham TMS 4 hours after surgery
11148113|NCT01861574|OG000|Outcome|All Participants|All 108 participants
11148114|NCT01861574|OG000|Outcome|Correct Guess|57 of 108 Participants guessed the correct TMS condition
11148115|NCT01861574|OG001|Outcome|Incorrect Guess|51 of 108 Participants incorrectly guessed their TMS condition
11148116|NCT01861574|EG000|Reported Event|Both Real TMS|Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
11148117|NCT01861574|EG001|Reported Event|Sham Then Real TMS|Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Real TMS 4 hours after gastric-bypass surgery
11148118|NCT01861574|EG002|Reported Event|Real Then Sham TMS|Gastric-Bypass Patients receive Real TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
11148119|NCT01861574|EG003|Reported Event|Both Sham TMS|Gastric-Bypass Patients receive Sham TMS 45 minutes after gastric-bypass surgery Gastric-Bypass Patients receive Sham TMS 4 hours after gastric-bypass surgery
11148120|NCT01861587|BG000|Baseline|Real tDCS:Active Comparator|tDCS: 20 minutes of either real or sham stimulation
11148121|NCT01861587|BG001|Baseline|Sham tDCS: Sham Comparator|tDCS: 20 minutes of either real or sham stimulation
11148122|NCT01861587|BG002|Baseline|Total|Total of all reporting groups
11148123|NCT01861587|FG000|Participant Flow|Real tDCS:Active Comparator|For Real tDCS, stimulation will be delivered in 20-minute-sessions using 2mA current. The anode will be placed over left BA9 or the motor cortex corresponding with the painful area (if applicable). The cathode will be placed over right BA43 (for GI pain) or right BA9 (located via the international 10-20 EEG system).
11148124|NCT01861587|FG001|Participant Flow|Sham tDCS: Sham Comparator|For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.
11148125|NCT01861587|OG000|Outcome|Real tDCS:Active Comparator|tDCS: 20 minutes of stimulation at 2mA.
11148126|NCT01861587|OG001|Outcome|Sham tDCS: Sham Comparator|For Sham tDCS, the stimulator was turned off automatically after 45 seconds.
11148127|NCT01861587|OG000|Outcome|Real tDCS:Active Comparator|tDCS: 20 minutes of either real or sham stimulation
11148128|NCT01861587|OG001|Outcome|Sham tDCS: Sham Comparator|tDCS: 20 minutes of either real or sham stimulation
11148129|NCT01861587|OG000|Outcome|Real tDCS|Real tDCS includes 20 minutes of stimulation at 2mA.
11148130|NCT01861587|OG001|Outcome|Sham tDCS|For sham tDCS, the stimulator was turned off automatically after 45 seconds.
11148131|NCT01861587|EG000|Reported Event|Real tDCS:Active Comparator|tDCS: 20 minutes of either real or sham stimulation
11148132|NCT01861587|EG001|Reported Event|Sham tDCS: Sham Comparator|tDCS: 20 minutes of either real or sham stimulation
11148133|NCT01861665|BG000|Baseline|Medication Pre Incision Left Med Post Incision Right|Participants acted as their own control with left side being injected with medication pre incision and right side being injected with medication post incision.
11148134|NCT01861665|BG001|Baseline|Medication Pre Incision Right Med Post Incision Left|Participants acted as their own control with right side being injected with medication pre incision and left side being injected with medication post incision.
11148135|NCT01861665|BG002|Baseline|Total|Total of all reporting groups
11148136|NCT01861665|FG000|Participant Flow|Medication Pre Incision Left Med Post Incision Right|Subjects acted as their own control with the left side being injected with the medication pre incision and the right side being injected with medication post incision.
11148137|NCT01861665|FG001|Participant Flow|Medication Pre Incision Right Med Post Incision Left|Subjects acted as their own control with right side being injected with the medication pre incision and left side being injected with the medication post incision.
11148138|NCT01861665|OG000|Outcome|Marcaine Administered Pre-incision|"Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.~Marcaine- 0.25%: Marcaine 0.25% administered pre-incision."
11148139|NCT01861665|OG001|Outcome|Marcaine Administered Post Incision|"Post-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc post incision.~Marcaine- 0.25%: Marcaine 0.25% administered post-incision."
11148140|NCT01861665|EG000|Reported Event|Marcaine Administered Pre-incision.|"Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.~Marcaine- 0.25%: Marcaine 0.25% administered pre-incision."
11148141|NCT01861665|EG001|Reported Event|Marcaine Administered Post-incision|"Marcaine 0.25% administered post-incision, total amount 5cc per incision.~Marcaine 0.25%.: Marcaine 0.25% administered post-incision."
11148142|NCT01861704|BG000|Baseline|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
11148143|NCT01861704|BG001|Baseline|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
11148144|NCT01861704|BG002|Baseline|Total|Total of all reporting groups
11148145|NCT01861704|FG000|Participant Flow|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
11148146|NCT01861704|FG001|Participant Flow|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
11148147|NCT01861704|OG000|Outcome|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument~Only experienced ears counted"
11148148|NCT01861704|OG001|Outcome|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument~Only experienced ears counted"
11148149|NCT01861704|EG000|Reported Event|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
11148150|NCT01861704|EG001|Reported Event|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
11148151|NCT01861756|BG000|Baseline|Diabetes Medication Choice Decision Aid|
11148152|NCT01861756|BG001|Baseline|Usual Care|
11148153|NCT01861756|BG002|Baseline|Total|Total of all reporting groups
11148154|NCT01861756|FG000|Participant Flow|Diabetes Medication Choice Decision Aid|
11148155|NCT01861756|FG001|Participant Flow|Usual Care|
11148156|NCT01861756|OG000|Outcome|Diabetes Medication Choice Decision Aid|
11148157|NCT01861756|OG001|Outcome|Usual Care|
11148158|NCT01861756|EG000|Reported Event|Diabetes Medication Choice Decision Aid|
11148159|NCT01861756|EG001|Reported Event|Usual Care|
11148160|NCT01861925|BG000|Baseline|Normal Eye|Astigmatism smaller than 1.5 diopters
11148161|NCT01861925|BG001|Baseline|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
11148162|NCT01861925|BG002|Baseline|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
11148163|NCT01861925|BG003|Baseline|Total|Total of all reporting groups
11148164|NCT01861925|FG000|Participant Flow|Normal Eye|Astigmatism smaller than 1.5 diopters
11148165|NCT01861925|FG001|Participant Flow|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
11148166|NCT01861925|FG002|Participant Flow|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
11148167|NCT01861925|OG000|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
11148168|NCT01861925|OG001|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
11148169|NCT01861925|OG002|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
11148170|NCT01861925|OG000|Outcome|Regular Eye|"Astigmatism smaller than 1.5 diopters and regular astigmatism >= 1.5 diopters (group normal eye and large regular astigmatism)"
11148171|NCT01861925|EG000|Reported Event|Normal Eye|Astigmatism smaller than 1.5 diopters
11148172|NCT01861925|EG001|Reported Event|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
11148173|NCT01861925|EG002|Reported Event|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
11148174|NCT01862029|BG000|Baseline|Roflumilast|Subjects with overweight/obesity and pre-diabetes who started Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor.
11148175|NCT01862029|FG000|Participant Flow|Subjects Who Took Roflumilast|Subjects with overweight/obesity and pre-diabetes were to take Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, for a total of six weeks. They were to take roflumilast 250mcg daily for the first two weeks and then, 500mcg daily for the remaining four weeks.
11148176|NCT01862029|OG000|Outcome|Pre-roflumilast|Data before the subjects began taking roflumilast
11148177|NCT01862029|OG000|Outcome|Post-roflumilast|Data obtained after subjects took roflumilast for a total of six weeks
11148178|NCT01862029|EG000|Reported Event|Subjects Who Took Roflumilast|Subjects with overweight/obesity and pre-diabetes were assigned to take Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, for a total of six weeks as follows: 250mcg daily for the first two weeks and then, 500mcg daily for the remaining four weeks.
11148179|NCT01862133|BG000|Baseline|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
11148180|NCT01862133|FG000|Participant Flow|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.~141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
11148181|NCT01862133|FG001|Participant Flow|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.~11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study~2 physicians were excluded because their patients were mainly Spanish speaking~1 physician verbally agreed to be in the study but never signed the informed consent statement~8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study"
11148182|NCT01862133|OG000|Outcome|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.~141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
11150209|NCT01876368|OG000|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
11150210|NCT01876368|OG001|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
11148183|NCT01862133|OG001|Outcome|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.~11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study~2 physicians were excluded because their patients were mainly Spanish speaking~1 physician verbally agreed to be in the study but never signed the informed consent statement~8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study~24"
11148184|NCT01862133|EG000|Reported Event|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
11148185|NCT01862133|EG001|Reported Event|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences."
11148186|NCT01862159|BG000|Baseline|Operated Patients|All patients operated with a laparoscopic gastric bypass procedure in Sweden during the inclusion period.
11148187|NCT01862159|FG000|Participant Flow|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
11148188|NCT01862159|OG000|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
11148189|NCT01862159|EG000|Reported Event|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
11148190|NCT01862250|BG000|Baseline|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
11148191|NCT01862250|FG000|Participant Flow|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in Mean Arterial Pressure (MAP) or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in Heart Rate (HR) from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
11148192|NCT01862250|OG000|Outcome|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
11148193|NCT01862250|EG000|Reported Event|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
11148194|NCT01862328|BG000|Baseline|Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148195|NCT01862328|BG001|Baseline|Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148196|NCT01862328|BG002|Baseline|Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148197|NCT01862328|BG003|Baseline|Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148198|NCT01862328|BG004|Baseline|Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148199|NCT01862328|BG005|Baseline|Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148200|NCT01862328|BG006|Baseline|Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148201|NCT01862328|BG007|Baseline|Total|Total of all reporting groups
11148202|NCT01862328|FG000|Participant Flow|Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or progressive disease (PD) (up to Cycle 52).
11148203|NCT01862328|FG001|Participant Flow|Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148204|NCT01862328|FG002|Participant Flow|Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148205|NCT01862328|FG003|Participant Flow|Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148206|NCT01862328|FG004|Participant Flow|Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148207|NCT01862328|FG005|Participant Flow|Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148208|NCT01862328|FG006|Participant Flow|Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148209|NCT01862328|OG000|Outcome|Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148210|NCT01862328|OG001|Outcome|Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148211|NCT01862328|OG002|Outcome|Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148212|NCT01862328|OG003|Outcome|Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148213|NCT01862328|OG004|Outcome|Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148214|NCT01862328|OG005|Outcome|Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148215|NCT01862328|OG006|Outcome|Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148216|NCT01862328|OG002|Outcome|Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148217|NCT01862328|OG003|Outcome|Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148218|NCT01862328|OG004|Outcome|Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11012937|NCT01118988|EG000|Reported Event|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
11012938|NCT01118988|EG001|Reported Event|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
11012939|NCT01118988|EG002|Reported Event|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
11012940|NCT01119001|BG000|Baseline|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
11012941|NCT01119001|FG000|Participant Flow|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
11012942|NCT01119001|OG000|Outcome|Brain-computer Interface (BCI) Environment|Accuracy typing for three sessions with the BCI acting as a stand-alone device.
11012943|NCT01119001|OG001|Outcome|Computer Environment|Accuracy typing for three sessions with the BCI acting as a keyboard for a laptop computer.
11012944|NCT01119001|OG002|Outcome|Assistive Technology Enironment|Accuracy typing for three sessions with the BCI acting as a keyboard for a Dynawrite communication system.
11012945|NCT01119001|EG000|Reported Event|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
11012946|NCT01119040|BG000|Baseline|Peg Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
11012947|NCT01119040|FG000|Participant Flow|"NOTES PEG Rescue"|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
11012948|NCT01119040|OG000|Outcome|NOTES PEG Rescue|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
11012949|NCT01119040|EG000|Reported Event|NOTES PEG Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
11012950|NCT01119105|BG000|Baseline|BC-3781 Dose 100mg|BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012951|NCT01119105|BG001|Baseline|BC-3781 Dose 150mg|BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012952|NCT01119105|BG002|Baseline|Vancomycin|Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012953|NCT01119105|BG003|Baseline|Total|Total of all reporting groups
11012954|NCT01119105|FG000|Participant Flow|BC-3781 Dose 100mg|BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012955|NCT01119105|FG001|Participant Flow|BC-3781 Dose 150mg|BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012956|NCT01119105|FG002|Participant Flow|Vancomycin|Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012957|NCT01119105|OG000|Outcome|BC-3781 Dose 100mg|BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012958|NCT01119105|OG001|Outcome|BC-3781 Dose 150mg|BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012959|NCT01119105|OG002|Outcome|Vancomycin|Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012960|NCT01119105|EG000|Reported Event|BC-3781 Dose 100mg|BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012961|NCT01119105|EG001|Reported Event|BC-3781 Dose 150mg|BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012962|NCT01119105|EG002|Reported Event|Vancomycin|Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
11012963|NCT01119118|BG000|Baseline|ZD4054|ZD4054 + multimodal PET/MRI imaging
11012964|NCT01119118|FG000|Participant Flow|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
11012965|NCT01119118|OG000|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
11012966|NCT01119118|EG000|Reported Event|ZD4054|ZD4054 + multimodal PET/MRI imaging
11012967|NCT01119131|BG000|Baseline|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
11012968|NCT01119131|BG001|Baseline|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
11012969|NCT01119131|BG002|Baseline|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
11012970|NCT01119131|BG003|Baseline|Total|Total of all reporting groups
11012971|NCT01119131|FG000|Participant Flow|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
11012972|NCT01119131|FG001|Participant Flow|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
11012973|NCT01119131|FG002|Participant Flow|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
11012974|NCT01119131|OG000|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
11012975|NCT01119131|OG001|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
11012976|NCT01119131|OG002|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
11012977|NCT01119131|EG000|Reported Event|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
11012978|NCT01119131|EG001|Reported Event|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
11012979|NCT01119131|EG002|Reported Event|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
11012980|NCT01119222|BG000|Baseline|Entire Study Population|Includes all participants who initiated in any treatment sequence
11012981|NCT01119222|FG000|Participant Flow|Placebo, Morphine, Diphenhydramine, Gabapentin|Placebo (capsules, tablet and intravenous (IV) first, then morphine 10 mg IV, then diphenhydramine 50 mg tablet, then gabapentin 1200 mg capsule.
11012982|NCT01119222|FG001|Participant Flow|Morphine, Gabapentin, Placebo, Diphenhydramine|Morphine 10 mg intravenous (IV) first, then gabapentin 1200 mg capsule, placebo (capsules, tablet and IV), then diphenhydramine 50 mg tablet.
11012983|NCT01119222|FG002|Participant Flow|Gabapentin, Diphenhydramine, Morphine, Placebo|Gabapentin 1200 mg capsule first, then diphenhydramine 50 mg tablet, then morphine 10 mg intravenous (IV), then placebo (capsules, tablet and IV).
11012984|NCT01119222|FG003|Participant Flow|Diphenhydramine, Placebo, Gabapentin, Morphine|Diphenhydramine 50 mg tablet first, then placebo (capsules, tablet and intravenous (IV), then gabapentin 1200 mg capsule, then morphine 10 mg IV.
11012985|NCT01119222|OG000|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
11012986|NCT01119222|OG001|Outcome|Morphine|Morphine single IV 10 mg dose
11012987|NCT01119222|OG002|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
11012988|NCT01119222|OG003|Outcome|Placebo|Oral and IV doses to match active treatments
11012989|NCT01119222|OG000|Outcome|Gabpentin|Gabapentin 1200 mg
11012990|NCT01119222|OG001|Outcome|Morphine|Morphine 10 mg
11012991|NCT01119222|OG000|Outcome|Gabapentin|Gabapentin 1200 mg
11012992|NCT01119222|EG000|Reported Event|Gabapentin|Gabapentin single oral 1200 mg dose
11012993|NCT01119222|EG001|Reported Event|Morphine|Morphine single IV 10 mg dose
11012994|NCT01119222|EG002|Reported Event|Diphenhydramine|Diphenhydramine single oral 50 mg dose
11012995|NCT01119222|EG003|Reported Event|Placebo|Oral and IV doses to match active treatments
11012996|NCT01119248|BG000|Baseline|Not Applicable|prospective observational cohort study
11012997|NCT01119248|FG000|Participant Flow|Children Undergoing MRI|children ages 6 months to 8 years scheduled for MRI under general anesthesia
11012998|NCT01119248|OG000|Outcome|Children Undergoing MRI|children 6 months to 8 years requiring GA for MRI
11012999|NCT01119248|OG000|Outcome|Children Undergoing MRI|children ages 6 months to 8 years scheduled for MRI under general anesthesia
11013000|NCT01119248|EG000|Reported Event|Children Undergoing MRI|infants 6 months to children 8 years
11013001|NCT01119287|BG000|Baseline|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013002|NCT01119287|BG001|Baseline|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013003|NCT01119287|BG002|Baseline|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013004|NCT01119287|BG003|Baseline|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013005|NCT01119287|BG004|Baseline|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013006|NCT01119287|BG005|Baseline|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013007|NCT01119287|BG006|Baseline|Total|Total of all reporting groups
11013008|NCT01119287|FG000|Participant Flow|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11148219|NCT01862328|OG005|Outcome|Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11013009|NCT01119287|FG001|Participant Flow|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013010|NCT01119287|FG002|Participant Flow|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013011|NCT01119287|FG003|Participant Flow|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013012|NCT01119287|FG004|Participant Flow|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013013|NCT01119287|FG005|Participant Flow|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013014|NCT01119287|OG000|Outcome|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013015|NCT01119287|OG001|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013016|NCT01119287|OG002|Outcome|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013017|NCT01119287|OG003|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013018|NCT01119287|OG000|Outcome|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013019|NCT01119287|OG001|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013020|NCT01119287|OG002|Outcome|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013021|NCT01119287|EG000|Reported Event|Maxidex|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013022|NCT01119287|EG001|Reported Event|Patanol|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013023|NCT01119287|EG002|Reported Event|Tears Naturale II|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
11013024|NCT01119443|BG000|Baseline|Treatment Sequence A|1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
11013025|NCT01119443|BG001|Baseline|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
11013026|NCT01119443|BG002|Baseline|Total|Total of all reporting groups
11013027|NCT01119443|FG000|Participant Flow|Treatment Sequence A|1.5 mg x 1 tablet once daily (q.d.) fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
11013028|NCT01119443|FG001|Participant Flow|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
11013029|NCT01119443|OG000|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
11013030|NCT01119443|OG001|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
11013031|NCT01119443|OG000|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
11013032|NCT01119443|OG001|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
11013033|NCT01119443|EG000|Reported Event|Up-titration|Up-titration to 0.75mg (10 days)
11013034|NCT01119443|EG001|Reported Event|1.5 mg q.d. Fed|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fed condition (10days in crossover)
11013035|NCT01119443|EG002|Reported Event|1.5 mg q.d. Fast|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fast condition (10 days in crossover)
11013036|NCT01119456|BG000|Baseline|IMC-RON8 (5 mg/kg qw)|IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
11013037|NCT01119456|BG001|Baseline|IMC-RON8 (10 mg/kg qw)|"IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013038|NCT01119456|BG002|Baseline|IMC-RON8 (15 mg/kg qw)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013039|NCT01119456|BG003|Baseline|IMC-RON8 (15 mg/kg q2w)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013040|NCT01119456|BG004|Baseline|IMC-RON8 (20 mg/kg q2w|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11150211|NCT01876368|EG000|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
11013041|NCT01119456|BG005|Baseline|IMC-RON8 (30 mg/kg q2w)|"IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013042|NCT01119456|BG006|Baseline|IMC-RON8 (40 mg/kg q2w)|"IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013043|NCT01119456|BG007|Baseline|IMC-RON8 (20 mg/kg qw)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013044|NCT01119456|BG008|Baseline|Total|Total of all reporting groups
11013045|NCT01119456|FG000|Participant Flow|IMC-RON8 (5 mg/kg qw)|IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
11013046|NCT01119456|FG001|Participant Flow|IMC-RON8 (10 mg/kg qw)|"IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013047|NCT01119456|FG002|Participant Flow|IMC-RON8 (15 mg/kg qw)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013048|NCT01119456|FG003|Participant Flow|IMC-RON8 (20 mg/kg qw)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met"
11013049|NCT01119456|FG004|Participant Flow|IMC-RON8 (15 mg/kg q2w)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met"
11013050|NCT01119456|FG005|Participant Flow|IMC-RON8 (20 mg/kg q2w)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013051|NCT01119456|FG006|Participant Flow|IMC-RON8 (30 mg/kg q2w)|"IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013052|NCT01119456|FG007|Participant Flow|IMC-RON8 (40 mg/kg q2w)|"IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013053|NCT01119456|OG000|Outcome|IMC-RON8|"IMC-RON8: Escalating doses (up to 40 mg/kg IMC-RON8) administered IV either qw or q2w for each 4-week cycle.~Participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013054|NCT01119456|OG000|Outcome|IMC-RON8 (5 mg/kg qw)|IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
11013055|NCT01119456|OG001|Outcome|IMC-RON8 (10 mg/kg qw)|"IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013056|NCT01119456|OG002|Outcome|IMC-RON8 (15 mg/kg qw)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013057|NCT01119456|OG003|Outcome|IMC-RON8 (20 mg/kg qw)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013058|NCT01119456|OG004|Outcome|IMC-RON8 (15 mg/kg q2w)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013059|NCT01119456|OG005|Outcome|IMC-RON8 (20 mg/kg q2w)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013060|NCT01119456|OG006|Outcome|IMC-RON8 (30 mg/kg q2w)|"IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013061|NCT01119456|OG007|Outcome|IMC-RON8 (40 mg/kg q2w)|"IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013062|NCT01119456|OG003|Outcome|IMC-RON8 (15 mg/kg q2w)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013063|NCT01119456|OG004|Outcome|IMC-RON8 (20 mg/kg q2w)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013064|NCT01119456|OG005|Outcome|IMC-RON8 (30 mg/kg q2w)|"IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013065|NCT01119456|OG006|Outcome|IMC-RON8 (40 mg/kg q2w)|"IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013066|NCT01119456|OG007|Outcome|IMC-RON8 (20 mg/kg qw)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013067|NCT01119456|OG003|Outcome|IMC-RON8 (15 mg/kg q2w)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met"
11013068|NCT01119456|EG000|Reported Event|IMC-RON8 (5 mg/kg qw)|IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
11013069|NCT01119456|EG001|Reported Event|IMC-RON8 (10 mg/kg qw)|"IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013070|NCT01119456|EG002|Reported Event|IMC-RON8 (15 mg/kg qw)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013071|NCT01119456|EG003|Reported Event|IMC-RON8 (20 mg/kg qw)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.~Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013072|NCT01119456|EG004|Reported Event|IMC-RON8 (15 mg/kg q2w)|"IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013073|NCT01119456|EG005|Reported Event|IMC-RON8 (20 mg/kg q2w)|"IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013074|NCT01119456|EG006|Reported Event|IMC-RON8 (30 mg/kg q2w)|"IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013075|NCT01119456|EG007|Reported Event|IMC-RON8 (40 mg/kg q2w)|"IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.~Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met."
11013076|NCT01119508|BG000|Baseline|Ipilimumab + Temozolomide|Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
11013077|NCT01119508|FG000|Participant Flow|Ipilimumab + Temozolomide|Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
11013078|NCT01119508|OG000|Outcome|Ipilimumab + Temozolomide|Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
11013079|NCT01119508|EG000|Reported Event|Ipilimumab + Temozolomide|Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
11013080|NCT01119625|BG000|Baseline|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
11013081|NCT01119625|BG001|Baseline|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
11013082|NCT01119625|BG002|Baseline|Total|Total of all reporting groups
11013083|NCT01119625|FG000|Participant Flow|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
11013084|NCT01119625|FG001|Participant Flow|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
11013085|NCT01119625|OG000|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
11013086|NCT01119625|OG001|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
11013087|NCT01119625|EG000|Reported Event|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
11013088|NCT01119625|EG001|Reported Event|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
11013089|NCT01119703|BG000|Baseline|Younger Participants|Aged 25 to 40 years old
11013090|NCT01119703|BG001|Baseline|Elderly Participants|Aged 65 years and older
11013091|NCT01119703|BG002|Baseline|Total|Total of all reporting groups
11013092|NCT01119703|FG000|Participant Flow|Younger Participants|Participants 25 to 40 years of age.
11013093|NCT01119703|FG001|Participant Flow|Elderly Participants|Participants 65 years old and older.
11013094|NCT01119703|OG000|Outcome|Elderly Participants|Healthy participants 65 years of age and older.
11013095|NCT01119703|OG000|Outcome|Elderly Participants|Healthy participants 65 years of age and older
11013096|NCT01119703|EG000|Reported Event|All Participants|Participants who received at least one dose of each vaccine
11013097|NCT01119716|BG000|Baseline|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
11013098|NCT01119716|FG000|Participant Flow|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
11013099|NCT01119716|OG000|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
11013100|NCT01119716|OG001|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
11013101|NCT01119716|OG002|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
11013102|NCT01119716|OG000|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
11013103|NCT01119716|OG001|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
11148220|NCT01862328|OG000|Outcome|Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11013104|NCT01119716|EG000|Reported Event|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
11013105|NCT01119755|BG000|Baseline|Group 1|
11013106|NCT01119755|FG000|Participant Flow|Group 1|
11013107|NCT01119755|OG000|Outcome|Group 1|
11013108|NCT01119755|EG000|Reported Event|Group 1|
11013109|NCT01119768|BG000|Baseline|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
11013110|NCT01119768|BG001|Baseline|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
11013111|NCT01119768|BG002|Baseline|Total|Total of all reporting groups
11013112|NCT01119768|FG000|Participant Flow|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
11013113|NCT01119768|FG001|Participant Flow|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
11013114|NCT01119768|OG000|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
11013115|NCT01119768|OG001|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
11013116|NCT01119768|EG000|Reported Event|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
11225608|NCT02369510|FG000|Participant Flow|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
11013117|NCT01119768|EG001|Reported Event|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
11013118|NCT01119794|BG000|Baseline|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
11013119|NCT01119794|FG000|Participant Flow|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
11013120|NCT01119794|OG000|Outcome|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
11013121|NCT01119794|EG000|Reported Event|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
11013122|NCT01119846|BG000|Baseline|Part A|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive escalating doses of GSK1292263 25 mg, 150 mg and 800 mg in each of 3 periods along with placebo and sitagliptin 100 mg orally in the other 2 periods in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013123|NCT01119846|BG001|Baseline|Part B|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted or fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 minutes (min) after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
11013124|NCT01119846|BG002|Baseline|Part C|Participants were randomized to 14 days of dosing with 4 dose regimens of GSK1292263 (final doses were: 50 mg BID, 150 mg BID, 300 mg BID, and 600 mg once daily) or matching placebo (administered BID) or open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa.
11013125|NCT01119846|BG003|Baseline|Total|Total of all reporting groups
11013126|NCT01119846|FG000|Participant Flow|Part A|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive escalating doses of GSK1292263 25 milligrams (mg), 150 mg and 800 mg in each of 3 periods along with placebo and sitagliptin 100 mg orally in the other 2 periods in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the oral glucose tolerance test (OGTT).
11013127|NCT01119846|FG001|Participant Flow|Part B|In this part (Cohort 2), after the appropriate washout period, T2DM participants on monotherapy or sub-maximal anti-diabetic medications were randomized to receive a single dose of GSK1292263 800 mg orally in fasted or fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 minutes after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
11013128|NCT01119846|FG002|Participant Flow|Part C|Participants were randomized to 14 days of dosing with 4 dose regimens of GSK1292263 (final doses were: 50 mg twice daily [BID], 150 mg BID, 300 mg BID, and 600 mg once daily) or matching placebo (administered BID) or open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013129|NCT01119846|OG000|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013130|NCT01119846|OG001|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013131|NCT01119846|OG002|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013132|NCT01119846|OG003|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013133|NCT01119846|OG004|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013134|NCT01119846|OG000|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013135|NCT01119846|OG001|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013136|NCT01119846|OG002|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013137|NCT01119846|OG000|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013138|NCT01119846|OG001|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013139|NCT01119846|OG002|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013140|NCT01119846|OG003|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013141|NCT01119846|OG004|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013142|NCT01119846|OG005|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013143|NCT01119846|OG000|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11148221|NCT01862328|OG001|Outcome|Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11013144|NCT01119846|OG000|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013145|NCT01119846|OG001|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013146|NCT01119846|OG002|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013147|NCT01119846|OG000|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
11013148|NCT01119846|OG001|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
11013149|NCT01119846|EG000|Reported Event|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive matching placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013150|NCT01119846|EG001|Reported Event|Part A: GSK1292263 25 mg Orally|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013151|NCT01119846|EG002|Reported Event|Part A: GSK1292263 150 mg Orally|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013152|NCT01119846|EG003|Reported Event|Part A: GSK1292263 800 mg Orally|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013153|NCT01119846|EG004|Reported Event|Part A: Sitagliptin 100 mg Orally|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
11013154|NCT01119846|EG005|Reported Event|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
11013155|NCT01119846|EG006|Reported Event|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
11013156|NCT01119846|EG007|Reported Event|Part C: GSK1292263 50 mg BID Orally|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11148222|NCT01862328|EG000|Reported Event|Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11150212|NCT01876368|EG001|Reported Event|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
11013157|NCT01119846|EG008|Reported Event|Part C: GSK1292263 150 mg BID Orally|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013158|NCT01119846|EG009|Reported Event|Part C: GSK1292263 300 mg BID Orally|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013159|NCT01119846|EG010|Reported Event|Part C: GSK1292263 600 mg Once Daily Orally|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013160|NCT01119846|EG011|Reported Event|Part C: Placebo Orally|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013161|NCT01119846|EG012|Reported Event|Part C: Sitagliptin 100 mg Once Daily Orally|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
11013162|NCT01119859|BG000|Baseline|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
11013163|NCT01119859|BG001|Baseline|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
11013164|NCT01119859|BG002|Baseline|Total|Total of all reporting groups
11013165|NCT01119859|FG000|Participant Flow|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
11013166|NCT01119859|FG001|Participant Flow|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
11013167|NCT01119859|OG000|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
11013168|NCT01119859|OG001|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
11148223|NCT01862328|EG001|Reported Event|Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11013169|NCT01119859|EG000|Reported Event|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
11013170|NCT01119859|EG001|Reported Event|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
11013171|NCT01119898|BG000|Baseline|PENNSAID Gel|Diclofenac sodium 2.0% w/w
11013172|NCT01119898|BG001|Baseline|Vehicle|The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
11013173|NCT01119898|BG002|Baseline|Total|Total of all reporting groups
11013174|NCT01119898|FG000|Participant Flow|PENNSAID Gel|Diclofenac sodium 2.0% w/w
11013175|NCT01119898|FG001|Participant Flow|Vehicle|The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
11013176|NCT01119898|OG000|Outcome|PENNSAID Gel|"Diclofenac sodium 2.0% w/w~PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks"
11013177|NCT01119898|OG001|Outcome|Vehicle|"The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium~Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks"
11013178|NCT01119898|EG000|Reported Event|PENNSAID Gel|Diclofenac sodium 2.0% w/w
11013179|NCT01119898|EG001|Reported Event|Vehicle|The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
11013180|NCT01119937|BG000|Baseline|NVA237|50µg once daily
11013181|NCT01119937|BG001|Baseline|Tiotropium|18µg once daily
11013182|NCT01119937|BG002|Baseline|Total|Total of all reporting groups
11013183|NCT01119937|FG000|Participant Flow|NVA237|50µg once daily
11013184|NCT01119937|FG001|Participant Flow|Tiotropium|18µg once daily
11013185|NCT01119937|OG000|Outcome|NVA237|50µg once daily
11013186|NCT01119937|OG001|Outcome|Tiotropium|18µg once daily
11013187|NCT01119937|EG000|Reported Event|NVA237|50µg once daily
11013188|NCT01119937|EG001|Reported Event|Tiotropium|18µg once daily
11013189|NCT01119950|BG000|Baseline|All Participants|All participants in the safety set
11013190|NCT01119950|FG000|Participant Flow|Overall Study|"For the overall study, 388 participants were randomized and 1 non-randomized participant received drug in error and was discontinued. This participant was excluded from randomized number of patients but included in number of treated participants and in the safety set.~Out of the 388 participants randomized, 341 completed study treatment and 47 discontinued, including 3 misrandomized participants who did not receive any study medication."
11013191|NCT01119950|OG000|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
11013192|NCT01119950|OG000|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
11013193|NCT01119950|OG001|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
11013194|NCT01119950|OG002|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
11013195|NCT01119950|OG003|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
11013196|NCT01119950|OG004|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
11013197|NCT01119950|OG005|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
11013198|NCT01119950|OG006|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
11013199|NCT01119950|OG007|Outcome|Placebo|Placebo to NVA237 once daily
11013200|NCT01119950|OG000|Outcome|NVA237 12.5 ug q.d.|NVA237 25 ug once daily
11013201|NCT01119950|OG001|Outcome|NVA237 25 ug q.d.|NVA237 12.5 ug once daily
11013202|NCT01119950|OG002|Outcome|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug twice daily
11013203|NCT01119950|OG003|Outcome|NVA237 50 ug q.d.|NVA237 50 ug once daily
11013204|NCT01119950|OG004|Outcome|NVA237 25 ug b.i.d.|NVA237 25 ug twice daily
11013205|NCT01119950|OG005|Outcome|NVA237 100 ug q.d.|NVA237 100 ug once daily
11013206|NCT01119950|OG006|Outcome|NVA237 50 ug b.i.d.|NVA237 50 ug twice daily
11013207|NCT01119950|EG000|Reported Event|NVA237 12.5 ug q.d.|NVA237 12.5 ug q.d.
11013208|NCT01119950|EG001|Reported Event|NVA237 25 ug q.d.|NVA237 25 ug q.d.
11013209|NCT01119950|EG002|Reported Event|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug b.i.d.
11013210|NCT01119950|EG003|Reported Event|NVA237 50 ug q.d.|NVA237 50 ug q.d.
11013211|NCT01119950|EG004|Reported Event|NVA237 25 ug b.i.d.|NVA237 25 ug b.i.d.
11013212|NCT01119950|EG005|Reported Event|NVA237 100 ug q.d.|NVA237 100 ug q.d.
11013213|NCT01119950|EG006|Reported Event|NVA237 50 ug b.i.d.|NVA237 50 ug b.i.d.
11013214|NCT01119950|EG007|Reported Event|Placebo|Placebo
11013215|NCT01119963|BG000|Baseline|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013216|NCT01119963|BG001|Baseline|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013217|NCT01119963|BG002|Baseline|Total|Total of all reporting groups
11013218|NCT01119963|FG000|Participant Flow|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013219|NCT01119963|FG001|Participant Flow|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013220|NCT01119963|OG000|Outcome|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013221|NCT01119963|OG001|Outcome|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013222|NCT01119963|EG000|Reported Event|Neonate: 17-alpha Hydroxyprogesterone Caproate, Makena®|"Neonate:~250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013223|NCT01119963|EG001|Reported Event|Neonate: Placebo|"Neonate:~Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013224|NCT01119963|EG002|Reported Event|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013225|NCT01119963|EG003|Reported Event|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
11013226|NCT01120028|BG000|Baseline|Period 1: Alemtuzumab/Tacrolimus|"Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus~Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart.~Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab."
11013227|NCT01120028|BG001|Baseline|Period 1: Basiliximab/Tacrolimus|"Induction therapy allocation: Basiliximab and Tacrolimus~Basiliximab: 20 mg intravenously, two doses 96 hours apart.~Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab."
11013228|NCT01120028|BG002|Baseline|Period 2: Sirolimus|Sirolimus maintenance therapy: target trough level of 6-12 ng/mL for the first 6-months, then reducing to 5-10 ng/mL.
11013229|NCT01120028|BG003|Baseline|Period 2: Tacrolimus|Tacrolimus maintenance therapy: target trough level of 5-7 ng/mL.
11013230|NCT01120028|BG004|Baseline|Total|Total of all reporting groups
11013231|NCT01120028|FG000|Participant Flow|Period 1: Alemtuzumab/Tacrolimus|"Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus~Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart~Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab."
11013232|NCT01120028|FG001|Participant Flow|Period 1: Basiliximab/Tacrolimus|"Induction therapy allocation: Basiliximab and Tacrolimus~Basiliximab: 20 mg intravenously, two doses 96 hours apart~Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab"
11013233|NCT01120028|FG002|Participant Flow|Period 2: Sirolimus|Sirolimus maintenance therapy: target trough level of 6-12 ng/mL for the first 6-months, then reducing to 5-10 ng/mL.
11013234|NCT01120028|FG003|Participant Flow|Period 2: Tacrolimus|Tacrolimus maintenance therapy: target trough level of 5-7 ng/mL
11013235|NCT01120028|OG000|Outcome|Period 1: Alemtuzumab/Tacrolimus|"Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus~Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart~Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab."
11013236|NCT01120028|OG001|Outcome|Period 1: Basiliximab/Tacrolimus|"Induction therapy allocation: Basiliximab and Tacrolimus~Basiliximab: 20 mg intravenously, two doses 96 hours apart~Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab"
11013237|NCT01120028|OG000|Outcome|Period 2: Sirolimus|Sirolimus maintenance therapy: target trough level of 6-12 ng/mL for the first 6-months, then reducing to 5-10 ng/mL.
11013238|NCT01120028|OG001|Outcome|Period 2: Tacrolimus|Tacrolimus maintenance therapy: target trough level of 5-7 ng/mL
11013239|NCT01120028|OG000|Outcome|Period 1: Campath 1H/Tacrolimus|"Induction therapy allocation: Campath-1H and Tacrolimus~Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart~Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab."
11013240|NCT01120028|EG000|Reported Event|Period 1: Alemtuzumab/Tacrolimus|"Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus~Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart~Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab."
11013241|NCT01120028|EG001|Reported Event|Period 1: Basiliximab/Tacrolimus|"Induction therapy allocation: Basiliximab and Tacrolimus~Basiliximab: 20 mg intravenously, two doses 96 hours apart~Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab"
11013242|NCT01120028|EG002|Reported Event|Period 2: Sirolimus|"Maintenance therapy allocation: Sirolimus~Target trough level of 6-12 ng/mL for the first 6-months then reducing to 5-10 ng/nL"
11225609|NCT02369510|FG001|Participant Flow|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
11013243|NCT01120028|EG003|Reported Event|Period 2: Tacrolimus|"Maintenancy therapy allocation: Tacrolimus~Target trough level of 5-7 ng/mL"
11013244|NCT01120067|BG000|Baseline|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
11013245|NCT01120067|BG001|Baseline|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
11013246|NCT01120067|BG002|Baseline|Total|Total of all reporting groups
11013247|NCT01120067|FG000|Participant Flow|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
11013248|NCT01120067|FG001|Participant Flow|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
11013249|NCT01120067|OG000|Outcome|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
11013250|NCT01120067|OG001|Outcome|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
11013251|NCT01120067|EG000|Reported Event|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
11225610|NCT02369510|FG002|Participant Flow|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
11013252|NCT01120067|EG001|Reported Event|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
11013253|NCT01120093|BG000|Baseline|Overall Study Population|All patients randomized into the crossover study
11066077|NCT01390818|OG001|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066078|NCT01390818|OG002|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11013254|NCT01120093|FG000|Participant Flow|Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days."
11013255|NCT01120093|FG001|Participant Flow|Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
11013256|NCT01120093|FG002|Participant Flow|Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
11013257|NCT01120093|FG003|Participant Flow|Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
11013258|NCT01120093|FG004|Participant Flow|Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
11013259|NCT01120093|OG000|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
11013260|NCT01120093|OG001|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
11013261|NCT01120093|OG002|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
11013262|NCT01120093|OG003|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
11013263|NCT01120093|OG004|Outcome|Placebo|Placebo via inhalation
11013264|NCT01120093|EG000|Reported Event|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
11013265|NCT01120093|EG001|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
11013266|NCT01120093|EG002|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
11013267|NCT01120093|EG003|Reported Event|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days.
11013268|NCT01120093|EG004|Reported Event|Placebo|Inhaled placebo dose for 7 days.
11066079|NCT01390818|OG003|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066080|NCT01390818|OG004|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11013269|NCT01120184|BG000|Baseline|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
11013270|NCT01120184|BG001|Baseline|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
11013271|NCT01120184|BG002|Baseline|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
11013272|NCT01120184|BG003|Baseline|Total|Total of all reporting groups
11013273|NCT01120184|FG000|Participant Flow|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
11013274|NCT01120184|FG001|Participant Flow|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
11013275|NCT01120184|FG002|Participant Flow|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
11013276|NCT01120184|OG000|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
11225611|NCT02369510|OG000|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
11013277|NCT01120184|OG001|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
11013278|NCT01120184|OG002|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
11013279|NCT01120184|EG000|Reported Event|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
11013280|NCT01120184|EG001|Reported Event|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
11013281|NCT01120184|EG002|Reported Event|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
11066081|NCT01390818|OG005|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066082|NCT01390818|OG000|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11013282|NCT01120197|BG000|Baseline|Exercise Group|: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
11013283|NCT01120197|BG001|Baseline|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
11013284|NCT01120197|BG002|Baseline|Total|Total of all reporting groups
11013285|NCT01120197|FG000|Participant Flow|Exercise Group|"Exercise Group: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).~The intervention is in accordance with Rehabilitation treatment guidelines in postmenupausal and senile osteoporosis ( Bonaiuti et al. 2005)."
11013286|NCT01120197|FG001|Participant Flow|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
11013287|NCT01120197|OG000|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
11013288|NCT01120197|OG001|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
11013289|NCT01120197|OG001|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
11013290|NCT01120197|EG000|Reported Event|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
11013291|NCT01120197|EG001|Reported Event|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
11013292|NCT01120210|BG000|Baseline|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
11013293|NCT01120210|BG001|Baseline|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
11013294|NCT01120210|BG002|Baseline|Total|Total of all reporting groups
11013295|NCT01120210|FG000|Participant Flow|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
11013296|NCT01120210|FG001|Participant Flow|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
11013297|NCT01120210|OG000|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
11013298|NCT01120210|OG001|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
11013299|NCT01120210|EG000|Reported Event|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
11225612|NCT02369510|OG001|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
11013300|NCT01120210|EG001|Reported Event|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
11013301|NCT01120223|BG000|Baseline|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
11013302|NCT01120223|FG000|Participant Flow|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
11013303|NCT01120223|OG000|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
11013304|NCT01120223|EG000|Reported Event|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
11013305|NCT01120236|BG000|Baseline|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
11013306|NCT01120236|BG001|Baseline|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
11013307|NCT01120236|BG002|Baseline|Total|Total of all reporting groups
11013308|NCT01120236|FG000|Participant Flow|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
11013309|NCT01120236|FG001|Participant Flow|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
11013310|NCT01120236|OG000|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
11013311|NCT01120236|OG001|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
11013312|NCT01120236|OG000|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
11013313|NCT01120236|OG001|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
11013314|NCT01120236|OG000|Outcome|PSA Complete Response|Patients who had a PSA level of ≤ 0.2 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
11013315|NCT01120236|OG001|Outcome|PSA Partial Response|Patients who had a PSA level of >0.2 ng/mL and <= 4.0 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
11013316|NCT01120236|OG002|Outcome|PSA Non-Responders|Patients who had a PSA level of > 4.0 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
11225613|NCT02369510|OG002|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
11013317|NCT01120236|OG000|Outcome|CTC=0|No CTCs foundin 7.5 mL blood sample collected at baseline, pooled treatment arms
11013318|NCT01120236|OG001|Outcome|CTC= 1-4|1 to 4 CTCs found in 7.5 mL blood sample collected at baseline, pooled treatment arms
11013319|NCT01120236|OG002|Outcome|CTC= 5+|Five or more CTCs were found in 7.5 mL blood sample collected at baseline, pooled treatment arms
11066083|NCT01390818|OG000|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11013320|NCT01120236|EG000|Reported Event|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
11013321|NCT01120236|EG001|Reported Event|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
11013322|NCT01120275|BG000|Baseline|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
11013323|NCT01120275|FG000|Participant Flow|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
11013324|NCT01120275|OG000|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
11013325|NCT01120275|OG000|Outcome|RO4929097|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
11013326|NCT01120275|EG000|Reported Event|RO4929097|Patients receive gamma-secretase/Notch signaling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11225614|NCT02369510|EG000|Reported Event|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
11013327|NCT01120379|BG000|Baseline|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
11013328|NCT01120379|FG000|Participant Flow|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
11013329|NCT01120379|OG000|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
11013330|NCT01120379|EG000|Reported Event|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
11013331|NCT01120405|BG000|Baseline|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
11013332|NCT01120405|BG001|Baseline|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
11013333|NCT01120405|BG002|Baseline|Total|Total of all reporting groups
11013334|NCT01120405|FG000|Participant Flow|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
11013335|NCT01120405|FG001|Participant Flow|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
11013336|NCT01120405|OG000|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
11013337|NCT01120405|OG001|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
11013338|NCT01120405|OG000|Outcome|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
11013339|NCT01120405|OG001|Outcome|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
11013340|NCT01120405|EG000|Reported Event|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
11013341|NCT01120405|EG001|Reported Event|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
11013342|NCT01120600|BG000|Baseline|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
11013343|NCT01120600|BG001|Baseline|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
11013344|NCT01120600|BG002|Baseline|Total|Total of all reporting groups
11013345|NCT01120600|FG000|Participant Flow|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
11013346|NCT01120600|FG001|Participant Flow|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
11013347|NCT01120600|OG000|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
11013348|NCT01120600|OG001|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
11013349|NCT01120600|EG000|Reported Event|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
11013350|NCT01120600|EG001|Reported Event|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
11013351|NCT01120626|BG000|Baseline|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
11013352|NCT01120626|BG001|Baseline|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
11013353|NCT01120626|BG002|Baseline|Total|Total of all reporting groups
11013354|NCT01120626|FG000|Participant Flow|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
11013355|NCT01120626|FG001|Participant Flow|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
11013356|NCT01120626|OG000|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
11013357|NCT01120626|OG001|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
11013358|NCT01120626|EG000|Reported Event|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
11013359|NCT01120626|EG001|Reported Event|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
11013360|NCT01120639|BG000|Baseline|Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013361|NCT01120639|BG001|Baseline|Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013362|NCT01120639|BG002|Baseline|Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013363|NCT01120639|BG003|Baseline|Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013364|NCT01120639|BG004|Baseline|Total|Total of all reporting groups
11013365|NCT01120639|FG000|Participant Flow|Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013366|NCT01120639|FG001|Participant Flow|Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013367|NCT01120639|FG002|Participant Flow|Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013368|NCT01120639|FG003|Participant Flow|Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013369|NCT01120639|OG000|Outcome|Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013370|NCT01120639|OG001|Outcome|Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013371|NCT01120639|OG002|Outcome|Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013372|NCT01120639|OG003|Outcome|Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013373|NCT01120639|EG000|Reported Event|Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013374|NCT01120639|EG001|Reported Event|Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013375|NCT01120639|EG002|Reported Event|Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013376|NCT01120639|EG003|Reported Event|Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide|"Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.~Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.~Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)"
11013377|NCT01120691|BG000|Baseline|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
11013378|NCT01120691|BG001|Baseline|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
11013379|NCT01120691|BG002|Baseline|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013380|NCT01120691|BG003|Baseline|Total|Total of all reporting groups
11013381|NCT01120691|FG000|Participant Flow|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
11013382|NCT01120691|FG001|Participant Flow|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
11013383|NCT01120691|FG002|Participant Flow|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013384|NCT01120691|OG000|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013385|NCT01120691|OG001|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013386|NCT01120691|OG001|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013387|NCT01120691|OG000|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11225615|NCT02369510|EG001|Reported Event|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
11013388|NCT01120691|OG001|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013389|NCT01120691|OG002|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013390|NCT01120691|OG002|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks.Salbutamol/albuterol was available for rescue medication use throughout the study.
11013391|NCT01120691|EG000|Reported Event|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013392|NCT01120691|EG001|Reported Event|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013393|NCT01120691|EG002|Reported Event|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device. for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
11013394|NCT01120704|BG000|Baseline|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013395|NCT01120704|BG001|Baseline|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013396|NCT01120704|BG002|Baseline|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013397|NCT01120704|BG003|Baseline|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013398|NCT01120704|BG004|Baseline|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013399|NCT01120704|BG005|Baseline|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013400|NCT01120704|BG006|Baseline|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013401|NCT01120704|BG007|Baseline|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013402|NCT01120704|BG008|Baseline|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013403|NCT01120704|BG009|Baseline|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013404|NCT01120704|BG010|Baseline|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013405|NCT01120704|BG011|Baseline|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013406|NCT01120704|BG012|Baseline|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013407|NCT01120704|BG013|Baseline|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11148224|NCT01862328|EG002|Reported Event|Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148225|NCT01862328|EG003|Reported Event|Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11013408|NCT01120704|BG014|Baseline|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013409|NCT01120704|BG015|Baseline|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013410|NCT01120704|BG016|Baseline|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013411|NCT01120704|BG017|Baseline|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013412|NCT01120704|BG018|Baseline|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013413|NCT01120704|BG019|Baseline|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013414|NCT01120704|BG020|Baseline|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013415|NCT01120704|BG021|Baseline|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013416|NCT01120704|BG022|Baseline|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013417|NCT01120704|BG023|Baseline|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013418|NCT01120704|BG024|Baseline|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013419|NCT01120704|BG025|Baseline|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013420|NCT01120704|BG026|Baseline|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013421|NCT01120704|BG027|Baseline|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013422|NCT01120704|BG028|Baseline|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013423|NCT01120704|BG029|Baseline|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11066084|NCT01390818|OG001|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066085|NCT01390818|OG002|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066086|NCT01390818|OG003|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11013424|NCT01120704|BG030|Baseline|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013425|NCT01120704|BG031|Baseline|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013426|NCT01120704|BG032|Baseline|Total|Total of all reporting groups
11013427|NCT01120704|FG000|Participant Flow|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013428|NCT01120704|FG001|Participant Flow|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013429|NCT01120704|FG002|Participant Flow|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013430|NCT01120704|FG003|Participant Flow|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013431|NCT01120704|FG004|Participant Flow|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013432|NCT01120704|FG005|Participant Flow|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013433|NCT01120704|FG006|Participant Flow|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013434|NCT01120704|FG007|Participant Flow|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013435|NCT01120704|FG008|Participant Flow|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013436|NCT01120704|FG009|Participant Flow|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013437|NCT01120704|FG010|Participant Flow|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013438|NCT01120704|FG011|Participant Flow|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013439|NCT01120704|FG012|Participant Flow|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013440|NCT01120704|FG013|Participant Flow|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013441|NCT01120704|FG014|Participant Flow|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11066087|NCT01390818|OG004|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11013442|NCT01120704|FG015|Participant Flow|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013443|NCT01120704|FG016|Participant Flow|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013444|NCT01120704|FG017|Participant Flow|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013445|NCT01120704|FG018|Participant Flow|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013446|NCT01120704|FG019|Participant Flow|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013447|NCT01120704|FG020|Participant Flow|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013448|NCT01120704|FG021|Participant Flow|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013449|NCT01120704|FG022|Participant Flow|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013450|NCT01120704|FG023|Participant Flow|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013451|NCT01120704|FG024|Participant Flow|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013452|NCT01120704|FG025|Participant Flow|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013453|NCT01120704|FG026|Participant Flow|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013454|NCT01120704|FG027|Participant Flow|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013455|NCT01120704|FG028|Participant Flow|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013456|NCT01120704|FG029|Participant Flow|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11148226|NCT01862328|EG004|Reported Event|Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148227|NCT01862328|EG005|Reported Event|Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148228|NCT01862328|EG006|Reported Event|Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2|MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
11148229|NCT01862419|BG000|Baseline|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
11013457|NCT01120704|FG030|Participant Flow|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
11013458|NCT01120704|FG031|Participant Flow|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
11013459|NCT01120704|OG000|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
11013460|NCT01120704|OG001|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
11013461|NCT01120704|OG002|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
11013462|NCT01120704|OG003|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
11013463|NCT01120704|OG004|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
11013464|NCT01120704|OG005|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
11066088|NCT01390818|OG005|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066089|NCT01390818|OG006|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066090|NCT01390818|OG007|Outcome|NSCLC: SAR245409 70mg Once|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11225616|NCT02369510|EG002|Reported Event|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
11013465|NCT01120704|OG006|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
11013466|NCT01120704|OG007|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
11013467|NCT01120704|OG008|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
11013468|NCT01120704|OG009|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
11013469|NCT01120704|EG000|Reported Event|26 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum.~IF the participant smoked >10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants were also asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.~IF the participant smoked 5-10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants were also asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication"
11013470|NCT01120704|EG001|Reported Event|8 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum.~IF participant smoked >10 cigs/day AND is randomized to a 8 week condition: they were asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants were also asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.~IF participant smoked 5-10 cigs/day AND is randomized to the 8 week medication condition: they were asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants were also asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment."
11013471|NCT01120717|BG000|Baseline|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
11013472|NCT01120717|BG001|Baseline|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
11013473|NCT01120717|BG002|Baseline|Total|Total of all reporting groups
11013474|NCT01120717|FG000|Participant Flow|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
11013475|NCT01120717|FG001|Participant Flow|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
11013476|NCT01120717|OG000|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
11013477|NCT01120717|OG001|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
11013478|NCT01120717|EG000|Reported Event|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
11225617|NCT02369796|BG000|Baseline|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11013479|NCT01120717|EG001|Reported Event|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
11013480|NCT01120756|BG000|Baseline|Goal-oriented Attentional Self-regulation Training|"Goal-oriented attentional self-regulation training (GOALS).~This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice."
11013481|NCT01120756|BG001|Baseline|Brain Health Education|"Brain Health Education (EDU)~Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework."
11013482|NCT01120756|BG002|Baseline|Total|Total of all reporting groups
11013483|NCT01120756|FG000|Participant Flow|Goal-oriented Attentional Self-regulation Training|"Goal-oriented attentional self-regulation training (GOALS).~This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice."
11013484|NCT01120756|FG001|Participant Flow|Brain Health Education|"Brain Health Education (EDU)~Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework."
11013485|NCT01120756|OG000|Outcome|Goal-oriented Attentional Self-regulation Training|"Goal-oriented attentional self-regulation training (GOALS).~This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice."
11013486|NCT01120756|OG001|Outcome|Brain Health Education|"Brain Health Education (EDU)~Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework."
11013487|NCT01120756|EG000|Reported Event|Goal-oriented Attentional Self-regulation Training|"Goal-oriented attentional self-regulation training (GOALS).~This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice."
11013488|NCT01120756|EG001|Reported Event|Brain Health Education|"Brain Health Education (EDU)~Brain Health Education: Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework."
11013489|NCT01120782|BG000|Baseline|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
11013490|NCT01120782|FG000|Participant Flow|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
11013491|NCT01120782|OG000|Outcome|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
11013492|NCT01120782|EG000|Reported Event|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
11013493|NCT01120808|BG000|Baseline|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
11013494|NCT01120808|FG000|Participant Flow|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
11013495|NCT01120808|OG000|Outcome|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
11013496|NCT01120808|EG000|Reported Event|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
11013497|NCT01120834|BG000|Baseline|All Subjects|"azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5~Dose level 2: azacitidine 75 mg/m2 on days 1-5~Dose level 3: azacitidine 55 mg/m2 on days 1-5~Dose level 4: azacitidine 75 mg/m2 on days 1-5~Each cycle = 28 days. Subjects may receive up to 6 cycles.~vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.~Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.~Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.~Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.~Each cycle = 28 days. Subjects receive up to 6 cycles."
11013498|NCT01120834|FG000|Participant Flow|All Subjects|"azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5~Dose level 2: azacitidine 75 mg/m2 on days 1-5~Dose level 3: azacitidine 55 mg/m2 on days 1-5~Dose level 4: azacitidine 75 mg/m2 on days 1-5~Each cycle = 28 days. Subjects may receive up to 6 cycles.~vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.~Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.~Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.~Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.~Each cycle = 28 days. Subjects receive up to 6 cycles."
11013499|NCT01120834|OG000|Outcome|All Subjects|
11013500|NCT01120834|EG000|Reported Event|All Subjects|all subjects
11013501|NCT01120899|BG000|Baseline|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
11013502|NCT01120899|FG000|Participant Flow|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
11013503|NCT01120899|OG000|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
11013504|NCT01120899|EG000|Reported Event|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
11013505|NCT01120990|BG000|Baseline|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
11013506|NCT01120990|FG000|Participant Flow|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
11013507|NCT01120990|OG000|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
11148230|NCT01862419|BG001|Baseline|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
11013508|NCT01120990|EG000|Reported Event|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
11013509|NCT01121146|BG000|Baseline|Crosslinked Marathon Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
11013510|NCT01121146|BG001|Baseline|Standard Enduron Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
11013511|NCT01121146|BG002|Baseline|Total|Total of all reporting groups
11013512|NCT01121146|FG000|Participant Flow|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
11013513|NCT01121146|FG001|Participant Flow|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
11013514|NCT01121146|OG000|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
11013515|NCT01121146|OG001|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
11013516|NCT01121146|OG000|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and crosslinked polyethylene liner.
11013517|NCT01121146|EG000|Reported Event|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
11013518|NCT01121146|EG001|Reported Event|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
11013519|NCT01121172|BG000|Baseline|Obese|obese children and adolescents according to International Obesity Task Force criteria
11013520|NCT01121172|BG001|Baseline|Lean|lean children and adolescents matched for age and gender to the obese group
11013521|NCT01121172|BG002|Baseline|Total|Total of all reporting groups
11013522|NCT01121172|FG000|Participant Flow|Obese|obese children and adolescents according to International Obesity Task Force criteria
11013523|NCT01121172|FG001|Participant Flow|Lean|lean children and adolescents matched for age and gender to the obese group
11013524|NCT01121172|OG000|Outcome|Obese|obese children and adolescents according to International Obesity Task Force criteria
11013525|NCT01121172|OG001|Outcome|Lean|lean children and adolescents matched for age and gender to the obese group
11013526|NCT01121172|OG000|Outcome|Obese Group|Obese children and adolescents according to IOTF criteria
11013527|NCT01121172|EG000|Reported Event|Obese|obese children and adolescents according to International Obesity Task Force criteria
11013528|NCT01121172|EG001|Reported Event|Lean|lean children and adolescents matched for age and gender to the obese group
11013529|NCT01121185|BG000|Baseline|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
11148231|NCT01862419|BG002|Baseline|Total|Total of all reporting groups
11148232|NCT01862419|FG000|Participant Flow|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
11148233|NCT01862419|FG001|Participant Flow|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
11013530|NCT01121185|BG001|Baseline|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
11013531|NCT01121185|BG002|Baseline|Total|Total of all reporting groups
11013532|NCT01121185|FG000|Participant Flow|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
11013533|NCT01121185|FG001|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
11013534|NCT01121185|OG000|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
11013535|NCT01121185|OG001|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
11013536|NCT01121185|EG000|Reported Event|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
11013537|NCT01121185|EG001|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
11013538|NCT01121211|BG000|Baseline|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
11013539|NCT01121211|BG001|Baseline|Placebo|"Placebo x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
11013540|NCT01121211|BG002|Baseline|Total|Total of all reporting groups
11013541|NCT01121211|FG000|Participant Flow|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks."
11013542|NCT01121211|FG001|Participant Flow|Placebo|"Placebo x 24 weeks~Placebo: Placebo transdermal patch x 24 weeks"
11013543|NCT01121211|OG000|Outcome|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
11013544|NCT01121211|OG001|Outcome|Placebo|"Placebo x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
11013545|NCT01121211|EG000|Reported Event|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks."
11013546|NCT01121211|EG001|Reported Event|Placebo|"Placebo x 24 weeks~Placebo: Placebo transdermal patch x 24 weeks"
11013547|NCT01121224|BG000|Baseline|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11013548|NCT01121224|BG001|Baseline|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11013549|NCT01121224|BG002|Baseline|Total|Total of all reporting groups
11013550|NCT01121224|FG000|Participant Flow|Bare Metal Stent Group|"Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11066091|NCT01390818|OG008|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11148234|NCT01862419|OG000|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
11148235|NCT01862419|OG001|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
11013551|NCT01121224|FG001|Participant Flow|Drug Eluting Stent Group|"Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11013552|NCT01121224|OG000|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11013553|NCT01121224|OG001|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11013554|NCT01121224|OG000|Outcome|Bare Metal Stent Group|"Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11013555|NCT01121224|OG001|Outcome|Drug Eluting Stent Group|"Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11013556|NCT01121224|EG000|Reported Event|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11013557|NCT01121224|EG001|Reported Event|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
11225618|NCT02369796|BG001|Baseline|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225619|NCT02369796|BG002|Baseline|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225620|NCT02369796|BG003|Baseline|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
11013558|NCT01121250|BG000|Baseline|Telephone Discussion Groups|Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
11225621|NCT02369796|BG004|Baseline|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
11225622|NCT02369796|BG005|Baseline|Total|Total of all reporting groups
11225623|NCT02369796|FG000|Participant Flow|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225624|NCT02369796|FG001|Participant Flow|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225625|NCT02369796|FG002|Participant Flow|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225626|NCT02369796|FG003|Participant Flow|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
11225627|NCT02369796|FG004|Participant Flow|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
11225628|NCT02369796|OG000|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225629|NCT02369796|OG001|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225630|NCT02369796|OG002|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225631|NCT02369796|OG000|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
11013559|NCT01121250|BG001|Baseline|Education Sessions|Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
11013560|NCT01121250|BG002|Baseline|Usual Care|Participants do not receive any services.
11013561|NCT01121250|BG003|Baseline|Total|Total of all reporting groups
11013562|NCT01121250|FG000|Participant Flow|Telephone Discussion Groups|Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
11013563|NCT01121250|FG001|Participant Flow|Education Sessions|Education sessions: Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
11013564|NCT01121250|FG002|Participant Flow|Usual Care|Participants do not receive any services.
11013565|NCT01121250|OG000|Outcome|Telephone Discussion Groups|Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
11013566|NCT01121250|OG001|Outcome|Education Sessions|Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
11013567|NCT01121250|OG002|Outcome|Usual Care|Participants do not receive any services.
11013568|NCT01121250|EG000|Reported Event|Telephone Discussion Groups|Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
11013569|NCT01121250|EG001|Reported Event|Education Sessions|Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
11013570|NCT01121250|EG002|Reported Event|Usual Care|Participants do not receive any services.
11013571|NCT01121263|BG000|Baseline|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
11013572|NCT01121263|BG001|Baseline|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
11013573|NCT01121263|BG002|Baseline|Total|Total of all reporting groups
11013574|NCT01121263|FG000|Participant Flow|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
11013575|NCT01121263|FG001|Participant Flow|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
11013576|NCT01121263|OG000|Outcome|HCR Group (N=200)|Primary Outcome in Cohort 2: Intervention Cohort - HCR Group
11013577|NCT01121263|OG001|Outcome|PCI Group (N=98)|Primary Outcome in Cohort 2: Intervention Cohort - PCI Group
11013578|NCT01121263|OG000|Outcome|HCR Group (N=200)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - HCR Group
11013579|NCT01121263|OG001|Outcome|PCI Group (N=98)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - PCI Group
11013580|NCT01121263|EG000|Reported Event|HCR Group (N=200)|Serious Adverse Events in Cohort 2: Intervention Cohort - HCR Group
11013581|NCT01121263|EG001|Reported Event|PCI Group (N=98)|Serious Adverse Events in Cohort 2: Intervention Cohort - PCI Group
11013582|NCT01121393|BG000|Baseline|Afatinib 40 Milligram (mg)|Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
11013583|NCT01121393|BG001|Baseline|Gemcitabine / Cisplatin Chemotherapy|Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
11013584|NCT01121393|BG002|Baseline|Total|Total of all reporting groups
11148236|NCT01862419|EG000|Reported Event|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
11148237|NCT01862419|EG001|Reported Event|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
11225632|NCT02369796|OG001|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
11013585|NCT01121393|FG000|Participant Flow|Afatinib 40 Milligram (mg)|Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
11013586|NCT01121393|FG001|Participant Flow|Gemcitabine / Cisplatin Chemotherapy|Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
11013587|NCT01121393|OG000|Outcome|Afatinib 40 Milligram (mg)|Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
11013588|NCT01121393|OG001|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
11013589|NCT01121393|OG000|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) orally after a dose reduction.
11013590|NCT01121393|OG001|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.) orally
11013591|NCT01121393|OG002|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) orally after a dose escalation.
11013592|NCT01121393|OG000|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
11013593|NCT01121393|OG001|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
11013594|NCT01121393|OG002|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
11013595|NCT01121393|EG000|Reported Event|Afatinib 40 Milligram (mg)|Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
11013596|NCT01121393|EG001|Reported Event|Gemcitabine / Cisplatin Chemotherapy|Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
11013597|NCT01121406|BG000|Baseline|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."
11013598|NCT01121406|BG001|Baseline|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
11013599|NCT01121406|BG002|Baseline|Total|Total of all reporting groups
11013600|NCT01121406|FG000|Participant Flow|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."
11013601|NCT01121406|FG001|Participant Flow|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
11013602|NCT01121406|OG000|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."
11013603|NCT01121406|OG001|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
11013604|NCT01121406|OG002|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
11013605|NCT01121406|OG000|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."
11013606|NCT01121406|EG000|Reported Event|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."
11013607|NCT01121406|EG001|Reported Event|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
11013608|NCT01121406|EG002|Reported Event|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
11013609|NCT01121484|BG000|Baseline|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
11013610|NCT01121484|BG001|Baseline|Placebo|Matching placebo tablets once daily for 10 weeks
11013611|NCT01121484|BG002|Baseline|Total|Total of all reporting groups
11013612|NCT01121484|FG000|Participant Flow|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
11013613|NCT01121484|FG001|Participant Flow|Placebo|Matching placebo tablets once daily for 10 weeks
11013614|NCT01121484|OG000|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
11013615|NCT01121484|OG001|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
11013616|NCT01121484|EG000|Reported Event|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
11013617|NCT01121484|EG001|Reported Event|Placebo|Matching placebo tablets once daily for 10 weeks
11013618|NCT01121536|BG000|Baseline|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
11013619|NCT01121536|FG000|Participant Flow|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
11013620|NCT01121536|OG000|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
11013621|NCT01121536|EG000|Reported Event|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
11013622|NCT01121549|BG000|Baseline|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
11013623|NCT01121549|FG000|Participant Flow|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
11013624|NCT01121549|OG000|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
11013625|NCT01121549|EG000|Reported Event|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
11013626|NCT01121562|BG000|Baseline|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
11013627|NCT01121562|FG000|Participant Flow|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
11013628|NCT01121562|OG000|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
11013629|NCT01121562|EG000|Reported Event|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
11013630|NCT01121575|BG000|Baseline|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013631|NCT01121575|BG001|Baseline|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013632|NCT01121575|BG002|Baseline|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013633|NCT01121575|BG003|Baseline|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013634|NCT01121575|BG004|Baseline|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
11013635|NCT01121575|BG005|Baseline|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
11013636|NCT01121575|BG006|Baseline|Total|Total of all reporting groups
11013637|NCT01121575|FG000|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg twice a day (BID) and oral dacomitinib 30 mg once daily (QD). The first cycle was for 28 days thereafter, each cycle was 21 days.
11225633|NCT02369796|EG000|Reported Event|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11013638|NCT01121575|FG001|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013639|NCT01121575|FG002|Participant Flow|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013640|NCT01121575|FG003|Participant Flow|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013641|NCT01121575|FG004|Participant Flow|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
11013642|NCT01121575|FG005|Participant Flow|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
11013643|NCT01121575|OG000|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013644|NCT01121575|OG001|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013645|NCT01121575|OG002|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013646|NCT01121575|OG003|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
11066092|NCT01390818|OG009|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066093|NCT01390818|OG007|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066094|NCT01390818|OG005|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11013647|NCT01121575|OG000|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
11013648|NCT01121575|OG001|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
11013649|NCT01121575|OG000|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
11013650|NCT01121575|OG001|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule.
11013651|NCT01121575|OG001|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
11013652|NCT01121575|OG000|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
11013653|NCT01121575|OG001|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
11013654|NCT01121575|EG000|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013655|NCT01121575|EG001|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013656|NCT01121575|EG002|Reported Event|PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013657|NCT01121575|EG003|Reported Event|PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
11013658|NCT01121575|EG004|Reported Event|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
11013659|NCT01121575|EG005|Reported Event|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
11013660|NCT01121666|BG000|Baseline|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
11013661|NCT01121666|BG001|Baseline|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
11013662|NCT01121666|BG002|Baseline|Total|Total of all reporting groups
11013663|NCT01121666|FG000|Participant Flow|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
11013664|NCT01121666|FG001|Participant Flow|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
11013665|NCT01121666|OG000|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
11013666|NCT01121666|OG001|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
11013667|NCT01121666|EG000|Reported Event|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
11013668|NCT01121666|EG001|Reported Event|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
11013669|NCT01121757|BG000|Baseline|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11066095|NCT01390818|OG000|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11013670|NCT01121757|BG001|Baseline|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11013671|NCT01121757|BG002|Baseline|Total|Total of all reporting groups
11013672|NCT01121757|FG000|Participant Flow|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11013673|NCT01121757|FG001|Participant Flow|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11013674|NCT01121757|OG000|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11013675|NCT01121757|OG001|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11013676|NCT01121757|OG000|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11013677|NCT01121757|OG001|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11013678|NCT01121757|EG000|Reported Event|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11066096|NCT01390818|OG001|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066097|NCT01390818|OG002|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
10886162|NCT00492531|EG001|Reported Event|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
11013679|NCT01121757|EG001|Reported Event|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
11013680|NCT01121900|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
11013681|NCT01121900|FG000|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.~IR = Immediate Release."
11013682|NCT01121900|FG001|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.~IR = Immediate Release."
11013683|NCT01121900|OG000|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
11013684|NCT01121900|OG001|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
11013685|NCT01121900|EG000|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
11013686|NCT01121900|EG001|Reported Event|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
11013687|NCT01121913|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Trazodone Contramid® OAD (prototype 1) First, Trazodone Contramid® OAD (prototype 2) First, Triticco® First, and Desyrel® First.
11013688|NCT01121913|FG000|Participant Flow|Trazodone Contramid® OAD (Prototype 1) First|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase I; followed by 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase III; and 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
11148238|NCT01862484|BG000|Baseline|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
11148239|NCT01862484|BG001|Baseline|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
11013689|NCT01121913|FG001|Participant Flow|Trazodone Contramid® OAD (Prototype 2) First|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase I, followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase II; 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase III; and 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
11013690|NCT01121913|FG002|Participant Flow|Triticco® First|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase I; followed by 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
11013691|NCT01121913|FG003|Participant Flow|Desyrel® First|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase I; followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase II; 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
11013692|NCT01121913|OG000|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
11013693|NCT01121913|OG001|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
11013694|NCT01121913|OG002|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
11013695|NCT01121913|OG003|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
11013696|NCT01121913|EG000|Reported Event|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
11013697|NCT01121913|EG001|Reported Event|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
11013698|NCT01121913|EG002|Reported Event|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
11013699|NCT01121913|EG003|Reported Event|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
11013700|NCT01121926|BG000|Baseline|Entire Study Population|"Includes groups randomized to receive Trazodone Contramid® OAD (Once-A-Day) test product first and Trazodone IR (Apotex Corp.) reference product first.~IR = Immediate Release"
11013701|NCT01121926|FG000|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.~IR = Immediate Release."
11013702|NCT01121926|FG001|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.~IR = Immediate Release."
11013703|NCT01121926|OG000|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
11013704|NCT01121926|OG001|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
11013705|NCT01121926|EG000|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
11013706|NCT01121926|EG001|Reported Event|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
11013707|NCT01121939|BG000|Baseline|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
11013708|NCT01121939|FG000|Participant Flow|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
11013709|NCT01121939|OG000|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
11013710|NCT01121939|OG001|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
11013711|NCT01121939|OG002|Outcome|All Patients|All patients on study (treatment is same for all patients)
11013712|NCT01121939|OG000|Outcome|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
11013713|NCT01121939|EG000|Reported Event|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
11013714|NCT01121991|BG000|Baseline|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
11148240|NCT01862484|BG002|Baseline|Total|Total of all reporting groups
11148241|NCT01862484|FG000|Participant Flow|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
11013715|NCT01121991|FG000|Participant Flow|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
11013716|NCT01121991|OG000|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
11013717|NCT01121991|EG000|Reported Event|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
11013718|NCT01122030|BG000|Baseline|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
11013719|NCT01122030|BG001|Baseline|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013720|NCT01122030|BG002|Baseline|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013721|NCT01122030|BG003|Baseline|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
11013722|NCT01122030|BG004|Baseline|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013723|NCT01122030|BG005|Baseline|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013724|NCT01122030|BG006|Baseline|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013725|NCT01122030|BG007|Baseline|Total|Total of all reporting groups
11013726|NCT01122030|FG000|Participant Flow|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
11013727|NCT01122030|FG001|Participant Flow|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013728|NCT01122030|FG002|Participant Flow|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013729|NCT01122030|FG003|Participant Flow|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
11013730|NCT01122030|FG004|Participant Flow|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013731|NCT01122030|FG005|Participant Flow|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013732|NCT01122030|FG006|Participant Flow|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013733|NCT01122030|OG000|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
11013734|NCT01122030|OG001|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013735|NCT01122030|OG002|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013736|NCT01122030|OG003|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
11013737|NCT01122030|OG004|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013738|NCT01122030|OG005|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013739|NCT01122030|OG006|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013740|NCT01122030|OG000|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013741|NCT01122030|OG001|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013742|NCT01122030|OG002|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
11013743|NCT01122030|OG003|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013744|NCT01122030|OG004|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013745|NCT01122030|OG005|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013746|NCT01122030|EG000|Reported Event|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
11013747|NCT01122030|EG001|Reported Event|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013748|NCT01122030|EG002|Reported Event|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
11013749|NCT01122030|EG003|Reported Event|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
11013750|NCT01122030|EG004|Reported Event|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013751|NCT01122030|EG005|Reported Event|Naldemedine 1 mg|Participants received a single dose of 1mg naldemedine tablets administered on Day 15 under fasted conditions.
11013752|NCT01122030|EG006|Reported Event|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
11013753|NCT01122108|BG000|Baseline|Colesevelam HCl (3.75g) vs Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
11013754|NCT01122108|FG000|Participant Flow|Colesevelam HCl 3.75g First, Then Cholestyramine 12g|Colesevelam HCl 3.75g once orally in the first intervention and Cholestyramine 12g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
11013755|NCT01122108|FG001|Participant Flow|Cholestyramine 12g First, Then Colesevelam HCl 3.75|Cholestyramine 12g once orally in the first intervention and Colesevelam 3.75g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
11013756|NCT01122108|OG000|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
11013757|NCT01122108|OG001|Outcome|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
11013758|NCT01122108|OG001|Outcome|Cholestyramine (12g)|
11013759|NCT01122108|EG000|Reported Event|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
11013760|NCT01122108|EG001|Reported Event|Colesevelam HCl (3.75 Grams)|
11013761|NCT01122108|EG002|Reported Event|More Than 30 Minutes After Last Beverage|This group summarizes the adverse events that occurred more than 30 mintures after the last beverage administered, and thus cannot be attributed to one specific bile acid sequestrant.
11013762|NCT01122160|BG000|Baseline|All Study Participants|All participants received both interventions.
11013763|NCT01122160|FG000|Participant Flow|Placebo First, Then Omeprazole|Placebo with berries (blackberries + strawberries), followed by Omeprazole with berries (blackberries + strawberries)
11013764|NCT01122160|FG001|Participant Flow|Omeprazole First, Then Placebo|Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries), followed by placebo with berries (blackberries + strawberries)
11013765|NCT01122160|OG000|Outcome|Experimental|
11013766|NCT01122160|OG001|Outcome|Placebo|
11013767|NCT01122160|EG000|Reported Event|Experimental|
11013768|NCT01122160|EG001|Reported Event|Placebo|
11013769|NCT01122173|BG000|Baseline|Robotic Catheter Manipulation, Ablation|To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation.
11013770|NCT01122173|FG000|Participant Flow|Robotic Catheter Manipulation, Ablation|To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation.
11013771|NCT01122173|OG000|Outcome|Robotic Catheter Manipulation, Ablation|To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation.
11013772|NCT01122173|OG000|Outcome|Robotic Catheter Manipulation, Ablation|To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation
11013773|NCT01122173|EG000|Reported Event|Robotic Catheter Manipulation, Ablation|To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation.
11013774|NCT01122238|BG000|Baseline|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013775|NCT01122238|BG001|Baseline|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013776|NCT01122238|BG002|Baseline|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013777|NCT01122238|BG003|Baseline|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013778|NCT01122238|BG004|Baseline|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013779|NCT01122238|BG005|Baseline|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013780|NCT01122238|BG006|Baseline|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013781|NCT01122238|BG007|Baseline|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013782|NCT01122238|BG008|Baseline|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013783|NCT01122238|BG009|Baseline|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013784|NCT01122238|BG010|Baseline|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013785|NCT01122238|BG011|Baseline|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013786|NCT01122238|BG012|Baseline|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013787|NCT01122238|BG013|Baseline|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013788|NCT01122238|BG014|Baseline|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013789|NCT01122238|BG015|Baseline|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013790|NCT01122238|BG016|Baseline|Total|Total of all reporting groups
11013791|NCT01122238|FG000|Participant Flow|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013792|NCT01122238|FG001|Participant Flow|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013793|NCT01122238|FG002|Participant Flow|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013794|NCT01122238|FG003|Participant Flow|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013795|NCT01122238|FG004|Participant Flow|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013796|NCT01122238|FG005|Participant Flow|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013797|NCT01122238|FG006|Participant Flow|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013798|NCT01122238|FG007|Participant Flow|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013799|NCT01122238|FG008|Participant Flow|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013800|NCT01122238|FG009|Participant Flow|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013801|NCT01122238|FG010|Participant Flow|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013802|NCT01122238|FG011|Participant Flow|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013803|NCT01122238|FG012|Participant Flow|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013804|NCT01122238|FG013|Participant Flow|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11148242|NCT01862484|FG001|Participant Flow|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
11148243|NCT01862484|OG000|Outcome|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
11148244|NCT01862484|OG001|Outcome|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
11013805|NCT01122238|FG014|Participant Flow|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
11013806|NCT01122238|FG015|Participant Flow|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
11013807|NCT01122238|OG000|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
11013808|NCT01122238|OG001|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
11013809|NCT01122238|OG002|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
11013810|NCT01122238|OG003|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
11013811|NCT01122238|OG004|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
11013812|NCT01122238|OG005|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
11013813|NCT01122238|OG006|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
11013814|NCT01122238|OG007|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
11013815|NCT01122238|EG000|Reported Event|Prequit Combined Nicotine Patch + Gum|"Prequit Combined Nicotine Patch + Gum~Participants randomized to this condition received a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks."
11013816|NCT01122238|EG001|Reported Event|Prequit Nicotine Patch Only|"Prequit Nicotine Patch Only~Participants randomized to this condition received a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks."
11013817|NCT01122238|EG002|Reported Event|Prequit Nicotine Gum Only|"Prequit Nicotine Gum Only.~Participants randomized to this condition received a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks."
11013818|NCT01122238|EG003|Reported Event|No Medication|"No Medication~Participants randomized to this condition received no medication."
11013819|NCT01122264|BG000|Baseline|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
11013820|NCT01122264|BG001|Baseline|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
11013821|NCT01122264|BG002|Baseline|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
11013822|NCT01122264|BG003|Baseline|Total|Total of all reporting groups
11013823|NCT01122264|FG000|Participant Flow|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
11013824|NCT01122264|FG001|Participant Flow|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
11013825|NCT01122264|FG002|Participant Flow|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
11013826|NCT01122264|OG000|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
11013827|NCT01122264|OG001|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
11013828|NCT01122264|OG002|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
11013829|NCT01122264|OG000|Outcome|Entire Study Population|"Tadalafil On Demand: Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).~Tadalafil Once a Day: Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.~Sildenafil Citrate On Demand: Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day)."
11013830|NCT01122264|OG000|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
11013831|NCT01122264|OG001|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.
11013832|NCT01122264|OG002|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
11013833|NCT01122264|EG000|Reported Event|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
11013834|NCT01122264|EG001|Reported Event|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
11013835|NCT01122264|EG002|Reported Event|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
11013836|NCT01122316|BG000|Baseline|Metformin|Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
11013837|NCT01122316|FG000|Participant Flow|Metformin|Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
11013838|NCT01122316|OG000|Outcome|Metformin|Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
11013839|NCT01122316|EG000|Reported Event|Metformin|Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
11013840|NCT01122394|BG000|Baseline|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
11013841|NCT01122394|BG001|Baseline|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
11013842|NCT01122394|BG002|Baseline|Total|Total of all reporting groups
11013843|NCT01122394|FG000|Participant Flow|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
11013844|NCT01122394|FG001|Participant Flow|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
11013845|NCT01122394|OG000|Outcome|Tailored Intervention (TI)|"Tailored intervention based on the transtheoretical model~TI: Tailored intervention based on the transtheoretical model"
11013846|NCT01122394|OG001|Outcome|Attention Placebo (AP)|"Attention Placebo~AP: Attention placebo"
11013847|NCT01122394|OG000|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
11013848|NCT01122394|OG001|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
11013849|NCT01122394|EG000|Reported Event|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
11013850|NCT01122394|EG001|Reported Event|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
11013851|NCT01122446|BG000|Baseline|Placebo Comparator|"Two doses of placebo day 1 and 30~Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.~Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo."
11013852|NCT01122446|BG001|Baseline|Alum-GAD (Diamyd)|"20 microgram Diamyd day 1 and 30~Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.~Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd"
11013853|NCT01122446|BG002|Baseline|Total|Total of all reporting groups
11013854|NCT01122446|FG000|Participant Flow|Placebo Comparator|"Two doses of placebo day 1 and 30~Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.~Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo."
11225634|NCT02369796|EG001|Reported Event|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11013855|NCT01122446|FG001|Participant Flow|Alum-GAD (Diamyd)|"20 microgram Diamyd day 1 and 30~Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.~Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd"
11013856|NCT01122446|OG000|Outcome|Placebo Comparator|"Two doses of placebo day 1 and 30~Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.~Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo."
11013857|NCT01122446|OG001|Outcome|Alum-GAD (Diamyd)|"20 microgram Diamyd day 1 and 30~Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.~Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd"
11013858|NCT01122446|EG000|Reported Event|Placebo Comparator|"Two doses of placebo day 1 and 30~Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.~Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo."
11013859|NCT01122446|EG001|Reported Event|Alum-GAD (Diamyd)|"20 microgram Diamyd day 1 and 30~Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.~Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd"
11013860|NCT01122576|BG000|Baseline|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
11013861|NCT01122576|BG001|Baseline|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
11013862|NCT01122576|BG002|Baseline|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
11013863|NCT01122576|BG003|Baseline|Total|Total of all reporting groups
11013864|NCT01122576|FG000|Participant Flow|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
11225635|NCT02369796|EG002|Reported Event|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
11225636|NCT02369796|EG003|Reported Event|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
11013865|NCT01122576|FG001|Participant Flow|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
11013866|NCT01122576|FG002|Participant Flow|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
11013867|NCT01122576|OG000|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
11013868|NCT01122576|OG001|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
11013869|NCT01122576|OG002|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
11013870|NCT01122576|OG001|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and wer implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
11013871|NCT01122576|OG000|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
11013872|NCT01122576|OG001|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
11013873|NCT01122576|EG000|Reported Event|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
11013874|NCT01122576|EG001|Reported Event|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
11225637|NCT02369796|EG004|Reported Event|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
11225638|NCT02369835|BG000|Baseline|Arm I (Modified Dakin's Solution)|Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
11225639|NCT02369835|BG001|Baseline|Arm II (Placebo)|Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
11225640|NCT02369835|BG002|Baseline|Total|Total of all reporting groups
11225641|NCT02369835|FG000|Participant Flow|Arm I (Modified Dakin's Solution)|Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
11225642|NCT02369835|FG001|Participant Flow|Arm II (Placebo)|Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
11225643|NCT02369835|OG000|Outcome|Arm I (Modified Dakin's Solution)|Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
11225644|NCT02369835|OG001|Outcome|Arm II (Placebo)|Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
11013875|NCT01122576|EG002|Reported Event|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
11013876|NCT01122680|BG000|Baseline|Total.|Total number of patients randomised and treated at all in the study.
11013877|NCT01122680|FG000|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Phase I, with a matching Placebo in Phase II and with Tiotropium 1.25 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
11013878|NCT01122680|FG001|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Phase I, with Tiotropium 5 mcg in Phase II and with Tiotropium 2.5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
11013879|NCT01122680|FG002|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with a matching Placebo in Phase I, with Tiotropium 2.5 mcg in Phase II and with Tiotropium 5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
11013880|NCT01122680|FG003|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Phase I, with Tiotropium 1.25 mcg in Phase II and with a matching Placebo in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
11013881|NCT01122680|OG000|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11013882|NCT01122680|OG001|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11013883|NCT01122680|OG002|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11013884|NCT01122680|OG003|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11013885|NCT01122680|EG000|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11013886|NCT01122680|EG001|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11013887|NCT01122680|EG002|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11013888|NCT01122680|EG003|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11013889|NCT01122849|BG000|Baseline|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013890|NCT01122849|BG001|Baseline|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013891|NCT01122849|BG002|Baseline|Prototype Nasal Strip|Participants applied the Prototype nasal dilator strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013892|NCT01122849|BG003|Baseline|Total|Total of all reporting groups
11013893|NCT01122849|FG000|Participant Flow|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013894|NCT01122849|FG001|Participant Flow|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013895|NCT01122849|FG002|Participant Flow|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013896|NCT01122849|OG000|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013897|NCT01122849|OG001|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11225645|NCT02369835|EG000|Reported Event|Arm I (Modified Dakin's Solution)|Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
11013898|NCT01122849|OG002|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013899|NCT01122849|OG000|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. The strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013900|NCT01122849|OG001|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. The strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013901|NCT01122849|OG002|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. The strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013902|NCT01122849|OG002|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal dilator strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013903|NCT01122849|OG000|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013904|NCT01122849|OG001|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013905|NCT01122849|OG002|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013906|NCT01122849|OG001|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant
11013907|NCT01122849|OG000|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant
11013908|NCT01122849|OG002|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal dilator strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013909|NCT01122849|EG000|Reported Event|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013910|NCT01122849|EG001|Reported Event|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013911|NCT01122849|EG002|Reported Event|Prototype Nasal Dilator|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
11013912|NCT01122862|BG000|Baseline|All Randomized Participants|All randomized participants were included for baseline parameters evaluation.
11013913|NCT01122862|FG000|Participant Flow|Test Mouth Rinse|Participants swirled their oral cavity with 15 milliliters (mL) of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013914|NCT01122862|FG001|Participant Flow|Chlorhexidine Mouth Rinse (0.12%)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% weight by volume (w/v) chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013915|NCT01122862|FG002|Participant Flow|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013916|NCT01122862|OG000|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013917|NCT01122862|OG001|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013918|NCT01122862|OG001|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013919|NCT01122862|OG002|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013920|NCT01122862|EG000|Reported Event|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013921|NCT01122862|EG001|Reported Event|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013922|NCT01122862|EG002|Reported Event|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
11013923|NCT01122901|BG000|Baseline|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
11013924|NCT01122901|BG001|Baseline|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11013925|NCT01122901|BG002|Baseline|Total|Total of all reporting groups
11013926|NCT01122901|FG000|Participant Flow|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
11013927|NCT01122901|FG001|Participant Flow|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11013928|NCT01122901|OG000|Outcome|Group A (Post Surgery) & Group B (Pre-surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies~GROUP B Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11013929|NCT01122901|OG001|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11013930|NCT01122901|OG000|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11013931|NCT01122901|OG000|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
11013932|NCT01122901|OG000|Outcome|Group A (Post Surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11013933|NCT01122901|OG001|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
11013934|NCT01122901|OG002|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11148245|NCT01862484|EG000|Reported Event|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
11148246|NCT01862484|EG001|Reported Event|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
11148247|NCT01862536|BG000|Baseline|Placebo|"Placebo tablet~placebo: Daily use in double blind study."
11013935|NCT01122901|EG000|Reported Event|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
11013936|NCT01122901|EG001|Reported Event|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11013937|NCT01122927|BG000|Baseline|All Study Participants|Participants who entered open-label treatment phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11013938|NCT01122927|FG000|Participant Flow|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continued to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
11013939|NCT01122927|FG001|Participant Flow|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11013940|NCT01122927|OG000|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11013941|NCT01122927|OG000|Outcome|Tanner Score at Baseline of 1|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11013942|NCT01122927|OG001|Outcome|Tanner Score at Baseline of 2|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11013943|NCT01122927|OG002|Outcome|Tanner Score at Baseline of 3|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11148248|NCT01862536|BG001|Baseline|Tadalafil|"Daily use of tadalafil (study drug) at 40 mg orally.~Tadalafil: Daily use of study drug to treat pulmonary hypertension."
11148249|NCT01862536|BG002|Baseline|Total|Total of all reporting groups
11148250|NCT01862536|FG000|Participant Flow|Placebo|"Placebo tablet~placebo: Daily use in double blind study."
11148251|NCT01862536|FG001|Participant Flow|Tadalafil|"Daily use of tadalafil (study drug) at 40 mg orally.~Tadalafil: Daily use of study drug to treat pulmonary hypertension."
11148252|NCT01862536|OG000|Outcome|Placebo|"Placebo tablet~placebo: Daily use in double blind study."
11148253|NCT01862536|OG001|Outcome|Tadalafil|"Daily use of tadalafil (study drug) at 40 mg orally.~Tadalafil: Daily use of study drug to treat pulmonary hypertension."
11148254|NCT01862536|OG000|Outcome|Placebo|Placebo Tablet
11148255|NCT01862536|OG001|Outcome|Tadalafil|Daily use of tadalafil (study drug) at 40 mg. orally
11148256|NCT01862536|EG000|Reported Event|Placebo|"Placebo tablet~placebo: Daily use in double blind study."
11148257|NCT01862536|EG001|Reported Event|Tadalafil|"Daily use of tadalafil (study drug) at 40 mg orally.~Tadalafil: Daily use of study drug to treat pulmonary hypertension."
11148258|NCT01862614|BG000|Baseline|Articaine|Subjects receiving articaine injection.
11148259|NCT01862614|FG000|Participant Flow|Articaine (First)|Subjects receiving 1.8cc articaine injection at first appointment.
11148260|NCT01862614|FG001|Participant Flow|Buffered Articaine (First)|Subjects receiving injection of 1.8cc buffered articaine at first appointment.
11148261|NCT01862614|OG000|Outcome|Articaine|Subjects receiving articaine injection.
11148262|NCT01862614|OG001|Outcome|Buffered Articaine|Subjects receiving an injection of 1.8cc buffered articaine.
11148263|NCT01862614|EG000|Reported Event|Articaine|Subjects receiving injection of 1.8cc 4% articaine.
11148264|NCT01862614|EG001|Reported Event|Buffered Articaine|Subjects receiving injection of 1.8cc buffered 4% articaine.
11148265|NCT01862640|BG000|Baseline|Brexpiprazole 0.5 mg/Day|All randomized participants received orally brexpiprazole 0.25 milligrams (mg)/day as a starting dose, which was up titrated to 0.5 mg/day. The investigational medicinal product (IMP) was administered once daily in the form of a tablet.
11148266|NCT01862640|BG001|Baseline|Brexpiprazole 1 mg/Day|All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
11148267|NCT01862640|BG002|Baseline|Brexpiprazole 2 mg/Day|All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
11013944|NCT01122927|OG003|Outcome|Tanner Score at Baseline of 4|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11013945|NCT01122927|OG004|Outcome|Tanner Score at Baseline of 5|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11013946|NCT01122927|EG000|Reported Event|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continue to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
11013947|NCT01122927|EG001|Reported Event|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
11013948|NCT01123070|BG000|Baseline|Cohort 1 TL011 500 mg|Participants were administered 500 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013949|NCT01123070|BG001|Baseline|Cohort 2 TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013950|NCT01123070|BG002|Baseline|Double Blind TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013951|NCT01123070|BG003|Baseline|Double Blind MabThera 1000 mg|Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013952|NCT01123070|BG004|Baseline|Total|Total of all reporting groups
11013953|NCT01123070|FG000|Participant Flow|Cohort 1 TL011 500 mg|Participants were administered 500 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013954|NCT01123070|FG001|Participant Flow|Cohort 2 TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013955|NCT01123070|FG002|Participant Flow|Double Blind TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013956|NCT01123070|FG003|Participant Flow|Double Blind MabThera 1000 mg|Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013957|NCT01123070|OG000|Outcome|Double Blind TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013958|NCT01123070|OG001|Outcome|Double Blind MabThera 1000 mg|Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013959|NCT01123070|OG000|Outcome|Cohort 2 TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013960|NCT01123070|OG000|Outcome|Cohort 1 TL011 500 mg|Participants were administered 500 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013961|NCT01123070|OG001|Outcome|Cohort 2 TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013962|NCT01123070|EG000|Reported Event|Cohort 1 TL011 500 mg|Participants were administered 500 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013963|NCT01123070|EG001|Reported Event|Cohort 2 TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013964|NCT01123070|EG002|Reported Event|Double Blind TL011 1000 mg|Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013965|NCT01123070|EG003|Reported Event|Double Blind MabThera 1000 mg|Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15).
11013966|NCT01123083|BG000|Baseline|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
11013967|NCT01123083|BG001|Baseline|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
11013968|NCT01123083|BG002|Baseline|Total|Total of all reporting groups
11013969|NCT01123083|FG000|Participant Flow|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 milligrams (mg) as intravenous (IV) infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
11013970|NCT01123083|FG001|Participant Flow|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
11013971|NCT01123083|OG000|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
11013972|NCT01123083|OG001|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
11013973|NCT01123083|EG000|Reported Event|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
11013974|NCT01123083|EG001|Reported Event|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
11013975|NCT01123148|BG000|Baseline|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
11148268|NCT01862640|BG003|Baseline|Placebo|All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
11013976|NCT01123148|FG000|Participant Flow|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
11013977|NCT01123148|OG000|Outcome|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
11013978|NCT01123148|EG000|Reported Event|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
11013979|NCT01123161|BG000|Baseline|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
11013980|NCT01123161|BG001|Baseline|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
11013981|NCT01123161|BG002|Baseline|Total|Total of all reporting groups
11013982|NCT01123161|FG000|Participant Flow|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
11013983|NCT01123161|FG001|Participant Flow|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming."
11013984|NCT01123161|OG000|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
11013985|NCT01123161|OG001|Outcome|Group 2 : IV t-PA and Hypothermia|"IV tpa and hypothermia~hypothermia: Hypothermia is induced using the Celsius Control™ System"
11013986|NCT01123161|OG001|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
11013987|NCT01123161|OG001|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming."
11013988|NCT01123161|OG001|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering treatment includes buspirone, meperidine, and surface warming."
11013989|NCT01123161|EG000|Reported Event|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
11013990|NCT01123161|EG001|Reported Event|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming."
11013991|NCT01123200|BG000|Baseline|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
11013992|NCT01123200|FG000|Participant Flow|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
11013993|NCT01123200|OG000|Outcome|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
11013994|NCT01123200|EG000|Reported Event|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
11013995|NCT01123356|BG000|Baseline|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
11013996|NCT01123356|FG000|Participant Flow|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
11013997|NCT01123356|OG000|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
11013998|NCT01123356|OG000|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
11013999|NCT01123356|EG000|Reported Event|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
11066098|NCT01390818|OG003|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066099|NCT01390818|OG004|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject
11014000|NCT01123382|BG000|Baseline|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
11014001|NCT01123382|BG001|Baseline|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
11014002|NCT01123382|BG002|Baseline|Total|Total of all reporting groups
11014003|NCT01123382|FG000|Participant Flow|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
11014004|NCT01123382|FG001|Participant Flow|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
11014005|NCT01123382|OG000|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
11014006|NCT01123382|OG001|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
11014007|NCT01123382|EG000|Reported Event|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
11014008|NCT01123382|EG001|Reported Event|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
11014009|NCT01123395|BG000|Baseline|Colcrys® Intact Tab and Colcrys® Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
11014010|NCT01123395|FG000|Participant Flow|Colcrys® Intact Tab Then Colcrys® Dissolved in Apple Juice|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice, after an overnight fast of at least 10 hours
11148269|NCT01862640|BG004|Baseline|Total|Total of all reporting groups
11225646|NCT02369835|EG001|Reported Event|Arm II (Placebo)|Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
11014011|NCT01123395|FG001|Participant Flow|Colcrys® Dissolved in Apple Juice Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and dissolved in 20 mL of apple juice after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours.
11014012|NCT01123395|OG000|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
11014013|NCT01123395|OG001|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
11014014|NCT01123395|EG000|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
11014015|NCT01123395|EG001|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
11066100|NCT01390818|OG005|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066101|NCT01390818|OG006|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
11066102|NCT01390818|OG000|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066103|NCT01390818|OG001|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066104|NCT01390818|OG002|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066105|NCT01390818|OG003|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066106|NCT01390818|OG004|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066107|NCT01390818|OG005|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066108|NCT01390818|OG006|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066109|NCT01390818|OG007|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066110|NCT01390818|OG008|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066111|NCT01390818|OG009|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11066112|NCT01390818|OG010|Outcome|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
11014016|NCT01123512|BG000|Baseline|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
11014017|NCT01123512|BG001|Baseline|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
11014018|NCT01123512|BG002|Baseline|Total|Total of all reporting groups
11014019|NCT01123512|FG000|Participant Flow|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
11014020|NCT01123512|FG001|Participant Flow|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
11014021|NCT01123512|OG000|Outcome|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
11014022|NCT01123512|OG001|Outcome|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
11014023|NCT01123512|EG000|Reported Event|Kiva VCF Treatment System|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
11014024|NCT01123512|EG001|Reported Event|Balloon Kyphoplasty|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
11148270|NCT01862640|FG000|Participant Flow|Brexpiprazole 0.5 mg/Day|All randomized participants received orally brexpiprazole 0.25 milligrams (mg)/day as a starting dose, which was up titrated to 0.5 mg/day. The investigational medicinal product (IMP) was administered once daily in the form of a tablet.
11014025|NCT01123642|BG000|Baseline|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
11014026|NCT01123642|FG000|Participant Flow|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
11014027|NCT01123642|OG000|Outcome|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
11014028|NCT01123642|OG000|Outcome|OEF/OIF/OND Veterans|Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn Veterans
11014029|NCT01123642|EG000|Reported Event|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
11014030|NCT01123655|BG000|Baseline|30 or 50 ug APL/Day|"The study will have 3 treatment arms each with 10-12 patients who have demonstrated T cell immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients will be randomized to one of the 3 treatment arms. Each of the 3 treatments will be given for 16 weeks.~In keeping with a sequential dose escalation strategy, the originally proposed randomization scheme will be modified so that subjects will be randomized to receive:~either the lowest dose (30 micrograms) or placebo (Block 1). We will begin with the lowest dose (30 micrograms/day) and enroll 6 to receive 30 micrograms/day APL A12 and 2 to receive placebo for 16 weeks. Results will be reported to the DMC for a decision to proceed to the next block based on indications of safety APL A12: IND 103860: The study drug APL A12 is a man made (or synthesized) fragment similar to a portion of natural type II collagen, the major collagen found in joint cartilage. Cartilage is the tough, elastic tissue found in"
11014031|NCT01123655|BG001|Baseline|Placebo|"Block 3 (Arm 3) will include placebo and both doses of APL/A12 to ensure 10-12 patients are enrolled in each arm ( total of approximately 32 subjects) so we will have 24 subjects who complete the 16 weeks of study treatment. Arms 2 and 3 will run simultaneously.~APL A12: IND 103860: The study drug APL A12 is a man made (or synthesized) fragment similar to a portion of natural type II collagen, the major collagen found in joint cartilage. Cartilage is the tough, elastic tissue found in various parts of the body, including the joints. The best dose of APL A12 to use in patients with rheumatoid arthritis is not known."
11014032|NCT01123655|BG002|Baseline|Total|Total of all reporting groups
11014033|NCT01123655|FG000|Participant Flow|30 mcg of APL/Day|30 micrograms compared with placebo
11014034|NCT01123655|FG001|Participant Flow|50 ug APL/Day|50 mcg and 30mcg compared to placebo
11014035|NCT01123655|FG002|Participant Flow|Placebo|Placebo group
11014036|NCT01123655|OG000|Outcome|APL 30 and 50ug/Day|"30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.~APL A12: IND 103860: The study drug APL A12 is a man made (or synthesized) fragment similar to a portion of natural type II collagen, the major collagen found in joint cartilage. Cartilage is the tough, elastic tissue found in various parts of the body including the joints. The best dose of APL A12 to use in patients with RA is not known."
11014037|NCT01123655|OG001|Outcome|Placebo|"Block 3 (Arm 3) will include placebo.~Dose of placebo was 2ml of IV saline."
11014038|NCT01123655|EG000|Reported Event|30 ug and 50 ug APL/Day|"30 micrograms APL A12/day and 50 micrograms APL A12/day~APL A12: IND 103860: The study drug APL A12 is a man made (or synthesized) fragment similar to a portion of natural type II collagen, the major collagen found in joint cartilage. Cartilage is the tough, elastic tissue found in various parts of the body, including the joints. The best dose of APL A12 to use in patients with rheumatoid arthritis is not known."
11014039|NCT01123655|EG001|Reported Event|Placebo|"Block 3 (Arm 3) will include placebo~Dose was 2ml of IV saline."
11148271|NCT01862640|FG001|Participant Flow|Brexpiprazole 1 mg/Day|All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
11148272|NCT01862640|FG002|Participant Flow|Brexpiprazole 2 mg/Day|All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
11014040|NCT01123889|BG000|Baseline|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
11014041|NCT01123889|BG001|Baseline|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
11014042|NCT01123889|BG002|Baseline|Total|Total of all reporting groups
11014043|NCT01123889|FG000|Participant Flow|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
11014044|NCT01123889|FG001|Participant Flow|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
11014045|NCT01123889|OG000|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
11014046|NCT01123889|OG001|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
11014047|NCT01123889|EG000|Reported Event|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
11014048|NCT01123889|EG001|Reported Event|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
11014049|NCT01123928|BG000|Baseline|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
11014050|NCT01123928|BG001|Baseline|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
11014051|NCT01123928|BG002|Baseline|Total|Total of all reporting groups
11014052|NCT01123928|FG000|Participant Flow|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
11014053|NCT01123928|FG001|Participant Flow|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
11014054|NCT01123928|OG000|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
11014055|NCT01123928|OG001|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
11014056|NCT01123928|EG000|Reported Event|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
11014057|NCT01123928|EG001|Reported Event|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
11014058|NCT01123941|BG000|Baseline|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
11014059|NCT01123941|BG001|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
11014060|NCT01123941|BG002|Baseline|Total|Total of all reporting groups
11014061|NCT01123941|FG000|Participant Flow|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
11014062|NCT01123941|FG001|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
11014063|NCT01123941|OG000|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
11014064|NCT01123941|OG001|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
11014065|NCT01123941|EG000|Reported Event|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
11014066|NCT01123941|EG001|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
11014067|NCT01123980|BG000|Baseline|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
11014068|NCT01123980|BG001|Baseline|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
11014069|NCT01123980|BG002|Baseline|Total|Total of all reporting groups
11014070|NCT01123980|FG000|Participant Flow|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
11014071|NCT01123980|FG001|Participant Flow|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
11014072|NCT01123980|OG000|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
11014073|NCT01123980|OG001|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
11014074|NCT01123980|EG000|Reported Event|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
11014075|NCT01123980|EG001|Reported Event|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
11014076|NCT01124006|BG000|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11014077|NCT01124006|BG001|Baseline|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
11014078|NCT01124006|BG002|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11014079|NCT01124006|BG003|Baseline|Total|Total of all reporting groups
11014080|NCT01124006|FG000|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11014081|NCT01124006|FG001|Participant Flow|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
11014082|NCT01124006|FG002|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11014083|NCT01124006|OG000|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11014084|NCT01124006|OG001|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
11014085|NCT01124006|OG002|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11014086|NCT01124006|EG000|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11014087|NCT01124006|EG001|Reported Event|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
11014088|NCT01124006|EG002|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11014089|NCT01124045|BG000|Baseline|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
11014090|NCT01124045|BG001|Baseline|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
11014091|NCT01124045|BG002|Baseline|Total|Total of all reporting groups
11014092|NCT01124045|FG000|Participant Flow|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
11014093|NCT01124045|FG001|Participant Flow|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
11014094|NCT01124045|OG000|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
11014095|NCT01124045|OG001|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
11014096|NCT01124045|EG000|Reported Event|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
11014097|NCT01124045|EG001|Reported Event|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
11014098|NCT01124097|BG000|Baseline|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014099|NCT01124097|BG001|Baseline|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014100|NCT01124097|BG002|Baseline|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014101|NCT01124097|BG003|Baseline|Placebo|Placebo: Tablets will be used.
11014102|NCT01124097|BG004|Baseline|Total|Total of all reporting groups
11014103|NCT01124097|FG000|Participant Flow|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014104|NCT01124097|FG001|Participant Flow|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014105|NCT01124097|FG002|Participant Flow|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014106|NCT01124097|FG003|Participant Flow|Placebo|Placebo: Tablets will be used.
11014107|NCT01124097|OG000|Outcome|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014108|NCT01124097|OG001|Outcome|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014109|NCT01124097|OG002|Outcome|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014110|NCT01124097|OG003|Outcome|Placebo|Placebo: Tablets will be used.
10886163|NCT00492544|BG000|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
11014111|NCT01124097|EG000|Reported Event|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014112|NCT01124097|EG001|Reported Event|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014113|NCT01124097|EG002|Reported Event|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
11014114|NCT01124097|EG003|Reported Event|Placebo|Placebo: Tablets will be used.
11014115|NCT01124149|BG000|Baseline|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
11014116|NCT01124149|FG000|Participant Flow|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
11014117|NCT01124149|OG000|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
11014118|NCT01124149|OG001|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
11014119|NCT01124149|OG000|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
11014120|NCT01124149|EG000|Reported Event|MMX Mesalamine/ Mesalazine (Acute Phase)|4.8g/day given QD for 8 weeks in the Acute Phase
11014121|NCT01124149|EG001|Reported Event|MMX Mesalamine/ Mesalazine (Maintenance Phase)|2.4 g/day given QD for 12 months in the Maintenance Phase
11014122|NCT01124162|BG000|Baseline|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
11014123|NCT01124162|BG001|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
11014124|NCT01124162|BG002|Baseline|Total|Total of all reporting groups
11014125|NCT01124162|FG000|Participant Flow|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
11014126|NCT01124162|FG001|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
11014127|NCT01124162|OG000|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
11014128|NCT01124162|OG001|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
11014129|NCT01124162|EG000|Reported Event|Losartan|100 mg Losartan Tablets test product dosed in either period.
11014130|NCT01124162|EG001|Reported Event|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
11014131|NCT01124175|BG000|Baseline|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
11014132|NCT01124175|BG001|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
11014133|NCT01124175|BG002|Baseline|Total|Total of all reporting groups
11014134|NCT01124175|FG000|Participant Flow|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
11014135|NCT01124175|FG001|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
11014136|NCT01124175|OG000|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
11014137|NCT01124175|OG001|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
11148273|NCT01862640|FG003|Participant Flow|Placebo|All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
11148274|NCT01862640|OG000|Outcome|Brexpiprazole 2 mg/Day|All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
11148275|NCT01862640|OG001|Outcome|Brexpiprazole 1 mg/Day|All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
11148276|NCT01862640|OG002|Outcome|Placebo|All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
11014138|NCT01124175|EG000|Reported Event|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
11014139|NCT01124175|EG001|Reported Event|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
11014140|NCT01124188|BG000|Baseline|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
11014141|NCT01124188|BG001|Baseline|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
11014142|NCT01124188|BG002|Baseline|Total|Total of all reporting groups
11014143|NCT01124188|FG000|Participant Flow|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
11014144|NCT01124188|FG001|Participant Flow|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
11014145|NCT01124188|OG000|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
11014146|NCT01124188|OG001|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
11014147|NCT01124188|EG000|Reported Event|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
11148277|NCT01862640|EG000|Reported Event|Brexpiprazole 0.5 mg/Day|All randomized participants received orally brexpiprazole 0.25 milligrams (mg)/day as a starting dose, which was up titrated to 0.5 mg/day. The investigational medicinal product (IMP) was administered once daily in the form of a tablet.
11148278|NCT01862640|EG001|Reported Event|Brexpiprazole 1 mg/Day|All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
11014148|NCT01124188|EG001|Reported Event|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
10886164|NCT00492544|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
11014149|NCT01124292|BG000|Baseline|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
11014150|NCT01124292|BG001|Baseline|Able-bodied Subject Without Tongue Piercing:|Able-bodied subjects who willing to receive a tongue piercing for this study.
11014151|NCT01124292|BG002|Baseline|Subjects With Spinal Cord Injury|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
11014152|NCT01124292|BG003|Baseline|Total|Total of all reporting groups
11014153|NCT01124292|FG000|Participant Flow|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
11014154|NCT01124292|FG001|Participant Flow|Able-bodied Subject Without Tongue Piercing|Able-bodied subjects who willing to receive a tongue piercing for this study.
11014155|NCT01124292|FG002|Participant Flow|Subjects With Spinal Cord Injury|persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
11014156|NCT01124292|OG000|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
11014157|NCT01124292|OG001|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
11014158|NCT01124292|OG002|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
11014159|NCT01124292|OG000|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
11014160|NCT01124292|OG002|Outcome|Subjects With Spinal Cord Injury (Group-C): Computer Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
11014161|NCT01124292|OG003|Outcome|Subjects With Spinal Cord Injury (Group-C): Wheelchair Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
11014162|NCT01124292|EG000|Reported Event|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
11014163|NCT01124292|EG001|Reported Event|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
11014164|NCT01124292|EG002|Reported Event|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
11014165|NCT01124305|BG000|Baseline|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
11014166|NCT01124305|BG001|Baseline|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
11014167|NCT01124305|BG002|Baseline|Total|Total of all reporting groups
11014168|NCT01124305|FG000|Participant Flow|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
11014169|NCT01124305|FG001|Participant Flow|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
11014170|NCT01124305|OG000|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
11014171|NCT01124305|OG001|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
11014172|NCT01124305|EG000|Reported Event|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
10886165|NCT00492544|OG000|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
11014173|NCT01124305|EG001|Reported Event|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
11014174|NCT01124370|BG000|Baseline|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
11014175|NCT01124370|FG000|Participant Flow|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
11014176|NCT01124370|OG000|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
11014177|NCT01124370|EG000|Reported Event|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
11014178|NCT01124422|BG000|Baseline|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
11014179|NCT01124422|BG001|Baseline|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
11014180|NCT01124422|BG002|Baseline|Total|Total of all reporting groups
11014181|NCT01124422|FG000|Participant Flow|Tiotropium (TIO)|Tiotropium (TIO) was administered in the dose of 18 micrograms (mcg) once daily for a duration of 4 weeks
11014182|NCT01124422|FG001|Participant Flow|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
11014183|NCT01124422|FG002|Participant Flow|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
11014184|NCT01124422|OG000|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
11014185|NCT01124422|OG001|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
11014186|NCT01124422|OG000|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
11014187|NCT01124422|EG000|Reported Event|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
11014188|NCT01124422|EG001|Reported Event|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
11014189|NCT01124448|BG000|Baseline|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
11014190|NCT01124448|BG001|Baseline|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
11014191|NCT01124448|BG002|Baseline|Total|Total of all reporting groups
11014192|NCT01124448|FG000|Participant Flow|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
11014193|NCT01124448|FG001|Participant Flow|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
11014194|NCT01124448|OG000|Outcome|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
11014195|NCT01124448|OG001|Outcome|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
11014196|NCT01124448|EG000|Reported Event|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
11014197|NCT01124448|EG001|Reported Event|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
11014198|NCT01124604|BG000|Baseline|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
11014199|NCT01124604|BG001|Baseline|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
11014200|NCT01124604|BG002|Baseline|Total|Total of all reporting groups
11014201|NCT01124604|FG000|Participant Flow|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
11014202|NCT01124604|FG001|Participant Flow|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
11014203|NCT01124604|OG000|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
11014204|NCT01124604|OG001|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
11014205|NCT01124604|EG000|Reported Event|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
11014206|NCT01124604|EG001|Reported Event|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
11014207|NCT01124617|BG000|Baseline|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
11014208|NCT01124617|BG001|Baseline|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
11014209|NCT01124617|BG002|Baseline|Total|Total of all reporting groups
11014210|NCT01124617|FG000|Participant Flow|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
11014211|NCT01124617|FG001|Participant Flow|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
11014212|NCT01124617|OG000|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
11014213|NCT01124617|OG001|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
11014214|NCT01124617|EG000|Reported Event|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
11014215|NCT01124617|EG001|Reported Event|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
11014216|NCT01124643|BG000|Baseline|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
11014217|NCT01124643|FG000|Participant Flow|Replagal® (0.2 mg/kg)|Replagal 0.2 milligram per kilogram (mg/kg) intravenously (IV), every other week (EOW).
11014218|NCT01124643|OG000|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
11014219|NCT01124643|EG000|Reported Event|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
11014220|NCT01124734|BG000|Baseline|Course 1 Cycles 1 and 2|"Course 1 Cycles of Part 1: Participants will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg~Course 2: Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days. Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg. Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days."
11014221|NCT01124734|FG000|Participant Flow|Course 1 Cycle 1 and Cycle 2|"This study is a single arm study. All participants received the same treatment regimen.~For initiation of study intervention (Course 1 - Cycle 1) participants are admitted inpatient for Course 1 Cycle 1 of HD IL-2 treatment. Participants will be given as many doses of IL-2 as tolerated up to a maximum of 14 at 8 hr intervals as allowed by the algorithm at 600,000 IU/kg. Participants will be discharged when the acute toxicities of the IL-2 have subsided.~Course 1 Cycle 2: After discharge, participants will be reassessed on or about 10 days after discharge (D10) and will be re-admitted to initiate Course 1 Cycle 2. For this Cycle 2, participants will be given as many doses of IL-2 as tolerated up to a maximum of 14 at 8 hr intervals as allowed by the algorithm at 600,000 IU/kg. After completion of this cycle 2 HD IL-2, they would begin Temzolomide at 75 mg/m2 on the day after hospital discharge. Participants will continue with Temzolomide for a total of 21 days."
11014222|NCT01124734|OG000|Outcome|Course 1 Cycle 1|"This study is a single arm study. All participants received the same treatment regimen.~Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.~Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg"
11014223|NCT01124734|OG001|Outcome|Course 1 Cycle 2|"Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.~Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg~Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days."
11014224|NCT01124734|OG000|Outcome|Course 1 Cycle 1 and Cycle 2|"This study is a single arm study. All participants received the same treatment regimen.~For initiation of study intervention (Course 1 - Cycle 1) participants are admitted inpatient for Course 1 Cycle 1 of HD IL-2 treatment. Participants will be given as many doses of IL-2 as tolerated up to a maximum of 14 at 8 hr intervals as allowed by the algorithm at 600,000 IU/kg. Participants will be discharged when the acute toxicities of the IL-2 have subsided.~Course 1 Cycle 2: After discharge, participants will be reassessed on or about 10 days after discharge (D10) and will be re-admitted to initiate Course 1 Cycle 2. For this Cycle 2, participants will be given as many doses of IL-2 as tolerated up to a maximum of 14 at 8 hr intervals as allowed by the algorithm at 600,000 IU/kg. After completion of this cycle 2 HD IL-2, they would begin Temzolomide at 75 mg/m2 on the day after hospital discharge. Participants will continue with Temzolomide for a total of 21 days."
11014225|NCT01124734|OG000|Outcome|% of Cells Expressing Phenotype Pre-treatment (BASELINE)|% of lymphocyte subset cells (particularly the T-reg cells, on cytokine production and anti-melanoma specific t-cell immune cells) that express the particular phenotype noted. Measured at pre-treatment time period (i.e. baseline)
11014226|NCT01124734|OG001|Outcome|% of Cells Expressing Phenotype Within 7 Days of Off-treatment|% of lymphocyte subset cells (particularly the T-reg cells, on cytokine production and anti-melanoma specific t-cell immune cells) that express the particular phenotype noted. Measured within 7 days the participant went off treatment. Note: Off treatment day will vary by participant and response to treatment/other intervening factors (toxicity, withdrawal of IC, etc).
11014227|NCT01124734|EG000|Reported Event|Course 1 Cycle 1|"This study is a single arm study. All participants received the same treatment regimen.~Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.~Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg"
11014228|NCT01124734|EG001|Reported Event|Course 1 Cycle 2|"Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.~Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg~Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days."
11014229|NCT01124786|BG000|Baseline|Gemcitabine Elaidate|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
11014230|NCT01124786|BG001|Baseline|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
11014231|NCT01124786|BG002|Baseline|Total|Total of all reporting groups
11014232|NCT01124786|FG000|Participant Flow|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
11014233|NCT01124786|FG001|Participant Flow|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
11014234|NCT01124786|OG000|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
11014235|NCT01124786|OG001|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
11014236|NCT01124786|EG000|Reported Event|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
11014237|NCT01124786|EG001|Reported Event|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
11014238|NCT01124838|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
10886166|NCT00492544|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
11014239|NCT01124838|BG001|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
11014240|NCT01124838|BG002|Baseline|Total|Total of all reporting groups
11014241|NCT01124838|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
11014242|NCT01124838|FG001|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
11014243|NCT01124838|OG000|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
11014244|NCT01124838|OG001|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
11014245|NCT01124838|OG002|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
11014246|NCT01124838|OG003|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
11014247|NCT01124838|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
10887258|NCT00499473|EG001|Reported Event|Stratum 2: EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib. In addition to EIAC (Enzyme-inducing anticonvulsant)
11014248|NCT01124838|EG001|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
11014249|NCT01124864|BG000|Baseline|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014250|NCT01124864|BG001|Baseline|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014251|NCT01124864|BG002|Baseline|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014252|NCT01124864|BG003|Baseline|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014253|NCT01124864|BG004|Baseline|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014254|NCT01124864|BG005|Baseline|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014255|NCT01124864|BG006|Baseline|Total|Total of all reporting groups
11014256|NCT01124864|FG000|Participant Flow|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014257|NCT01124864|FG001|Participant Flow|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014258|NCT01124864|FG002|Participant Flow|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014259|NCT01124864|FG003|Participant Flow|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014260|NCT01124864|FG004|Participant Flow|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014261|NCT01124864|FG005|Participant Flow||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014262|NCT01124864|OG000|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014263|NCT01124864|OG001|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014264|NCT01124864|OG002|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014265|NCT01124864|OG003|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014266|NCT01124864|OG004|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014267|NCT01124864|OG005|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11148279|NCT01862640|EG002|Reported Event|Brexpiprazole 2 mg/Day|All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
11148280|NCT01862640|EG003|Reported Event|Placebo|All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
11014268|NCT01124864|OG000|Outcome|AUY922|AUY922 Plasma Concentration
10887259|NCT00499486|BG000|Baseline|Sirolimus|adencarcinoma refractory to gemcitibine
11014269|NCT01124864|OG001|Outcome|BJP762|AUY Metabolite
11014270|NCT01124864|EG000|Reported Event|KRAS Mutant|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014271|NCT01124864|EG001|Reported Event|EGFR Mutant|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014272|NCT01124864|EG002|Reported Event|KRAS and EGFR Wild Type|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014273|NCT01124864|EG003|Reported Event|EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014274|NCT01124864|EG004|Reported Event|Modified EGFR Mutant|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI.Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014275|NCT01124864|EG005|Reported Event||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
11014276|NCT01124916|BG000|Baseline|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
11014277|NCT01124916|BG001|Baseline|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
11014278|NCT01124916|BG002|Baseline|Total|Total of all reporting groups
11014279|NCT01124916|FG000|Participant Flow|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
11014280|NCT01124916|FG001|Participant Flow|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
11014281|NCT01124916|OG000|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
11014282|NCT01124916|OG001|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
11014283|NCT01124916|EG000|Reported Event|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
11014284|NCT01124916|EG001|Reported Event|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
11014285|NCT01124955|BG000|Baseline|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
11014286|NCT01124955|BG001|Baseline|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
11014287|NCT01124955|BG002|Baseline|Total|Total of all reporting groups
11014288|NCT01124955|FG000|Participant Flow|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
11014289|NCT01124955|FG001|Participant Flow|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
11014290|NCT01124955|OG000|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
11014291|NCT01124955|OG001|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
11014292|NCT01124955|EG000|Reported Event|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
11014293|NCT01124955|EG001|Reported Event|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
11014294|NCT01125046|BG000|Baseline|Treatment With Bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months (1 cycle = 28 days with two doses of bevacizumab). Patients may then receive bevacizumab IV every 3 weeks for up to 12 months (1 cycle = 42 days) or stay on the 2 week cycle at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After 12 months of treatment patients may continue on bevacizumab at the discretion of their treating physician.~bevacizumab: Given IV"
11014295|NCT01125046|FG000|Participant Flow|Treatment With Bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months (1 cycle = 28 days with two doses of bevacizumab). Patients may then receive bevacizumab IV every 3 weeks for up to 12 months (1 cycle = 42 days) or stay on the 2 week cycle at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After 12 months of treatment patients may continue on bevacizumab at the discretion of their treating physician.~bevacizumab: Given IV"
11014296|NCT01125046|OG000|Outcome|Treatment With Bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months (1 cycle = 28 days with two doses of bevacizumab). Patients may then receive bevacizumab IV every 3 weeks for up to 12 months (1 cycle = 42 days) or stay on the 2 week cycle at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After 12 months of treatment patients may continue on bevacizumab at the discretion of their treating physician.~bevacizumab: Given IV"
11014297|NCT01125046|EG000|Reported Event|Treatment With Bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months (1 cycle = 28 days with two doses of bevacizumab). Patients may then receive bevacizumab IV every 3 weeks for up to 12 months (1 cycle = 42 days) or stay on the 2 week cycle at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After 12 months of treatment patients may continue on bevacizumab at the discretion of their treating physician.~bevacizumab: Given IV"
11014298|NCT01125098|BG000|Baseline|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
11014299|NCT01125098|BG001|Baseline|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
11014300|NCT01125098|BG002|Baseline|Total|Total of all reporting groups
11014301|NCT01125098|FG000|Participant Flow|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
11014302|NCT01125098|FG001|Participant Flow|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
11014303|NCT01125098|OG000|Outcome|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
11014304|NCT01125098|OG001|Outcome|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
11148281|NCT01862796|BG000|Baseline|Obese Underfeeding (UF)|"Obese randomized to received a 35% calorie reduced diet~Underfeeding diet: Heart healthy diet with 35% reduced calories"
11148282|NCT01862796|BG001|Baseline|Obese Weight Maintaining (WMEN)|"Randomized to receive a weight-maintaining diet~Weight maintaining diet: Heart healthy weight-maintaining diet"
11014305|NCT01125098|EG000|Reported Event|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
11014306|NCT01125098|EG001|Reported Event|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
11014307|NCT01125163|BG000|Baseline|Multivitamin With Iron|daily oral multivitamin providing 2mg/kg of iron
11014308|NCT01125163|BG001|Baseline|Multivitamin Without Iron|daily oral multivitamin without iron
11014309|NCT01125163|BG002|Baseline|Total|Total of all reporting groups
11014310|NCT01125163|FG000|Participant Flow|Multivitamin With Iron|daily oral multivitamin providing 2mg/kg of iron
11014311|NCT01125163|FG001|Participant Flow|Multivitamin Without Iron|daily oral multivitamin without iron
11014312|NCT01125163|OG000|Outcome|Multivitamin With Iron|daily oral multivitamin providing 2mg/kg/day of iron
11014313|NCT01125163|OG001|Outcome|Multivitamin Without Iron|daily oral multivitamin without iron
11014314|NCT01125163|OG000|Outcome|Multivitamin With Iron|daily oral multivitamin providing 2mg/kg of iron
11225647|NCT02369848|BG000|Baseline|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
11225648|NCT02369848|FG000|Participant Flow|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
11014315|NCT01125163|EG000|Reported Event|Multivitamin With Iron|daily oral multivitamin providing 2mg/kg of iron
11014316|NCT01125163|EG001|Reported Event|Multivitamin Without Iron|daily oral multivitamin without iron
11014317|NCT01125189|BG000|Baseline|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
11014318|NCT01125189|BG001|Baseline|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
11014319|NCT01125189|BG002|Baseline|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
11014320|NCT01125189|BG003|Baseline|Total|Total of all reporting groups
11014321|NCT01125189|FG000|Participant Flow|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
11014322|NCT01125189|FG001|Participant Flow|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
11014323|NCT01125189|FG002|Participant Flow|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
11014324|NCT01125189|OG000|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
11014325|NCT01125189|OG001|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
11014326|NCT01125189|OG002|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
11014327|NCT01125189|OG000|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated--interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
11014328|NCT01125189|OG002|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylate--interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
11014329|NCT01125189|OG001|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated--interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
11014330|NCT01125189|EG000|Reported Event|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated--interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
11014331|NCT01125189|EG001|Reported Event|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
11014332|NCT01125189|EG002|Reported Event|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
11014333|NCT01125202|BG000|Baseline|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
11014334|NCT01125202|BG001|Baseline|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
11014335|NCT01125202|BG002|Baseline|Total|Total of all reporting groups
11014336|NCT01125202|FG000|Participant Flow|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
11014337|NCT01125202|FG001|Participant Flow|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
11148283|NCT01862796|BG002|Baseline|Lean Weight Maintaining (WMEN)|"Normal weight individuals receiving a weight-maintaining energy needs diet~Weight maintaining diet: Heart healthy weight-maintaining diet"
11148284|NCT01862796|BG003|Baseline|Total|Total of all reporting groups
11148285|NCT01862796|FG000|Participant Flow|Obese Underfeeding (UF)|"Obese randomized to received a 35% calorie reduced diet~Underfeeding diet: Heart healthy diet with 35% reduced calories"
11014338|NCT01125202|OG000|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
11014339|NCT01125202|OG001|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
11014340|NCT01125202|EG000|Reported Event|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
11014341|NCT01125202|EG001|Reported Event|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
11014342|NCT01125293|BG000|Baseline|Phase I Stage A Level 1|"Combination of everolimus & rituximab for 6 cycles~Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014343|NCT01125293|BG001|Baseline|Phase I Stage A Level 2|"Combination of everolimus & rituximab for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014344|NCT01125293|BG002|Baseline|Phase I Stage B Level 1|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014345|NCT01125293|BG003|Baseline|Phase I Stage B Level 2|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014346|NCT01125293|BG004|Baseline|Phase I Dose Expansion|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014347|NCT01125293|BG005|Baseline|Phase II|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014348|NCT01125293|BG006|Baseline|Total|Total of all reporting groups
11014349|NCT01125293|FG000|Participant Flow|Phase I Stage A Level 1|"Combination of everolimus & rituximab for 6 cycles~Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014350|NCT01125293|FG001|Participant Flow|Phase I Stage A Level 2|"Combination of everolimus & rituximab for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014351|NCT01125293|FG002|Participant Flow|Phase I Stage B Level 1|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11148286|NCT01862796|FG001|Participant Flow|Obese Weight Maintaining (WMEN)|"Randomized to receive a weight-maintaining diet~Weight maintaining diet: Heart healthy weight-maintaining diet"
11148287|NCT01862796|FG002|Participant Flow|Lean Weight Maintaining (WMEN)|"Normal weight individuals receiving a weight-maintaining energy needs diet~Weight maintaining diet: Heart healthy weight-maintaining diet"
11148288|NCT01862796|OG000|Outcome|Obese Underfeeding (UF)|"Obese randomized to received a 35% calorie reduced diet~Underfeeding diet: Heart healthy diet with 35% reduced calories"
11148289|NCT01862796|OG001|Outcome|Obese Weight Maintaining (WMEN)|"Randomized to receive a weight-maintaining diet~Weight maintaining diet: Heart healthy weight-maintaining diet"
11014352|NCT01125293|FG003|Participant Flow|Phase I Stage B Level 2|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014353|NCT01125293|FG004|Participant Flow|Phase I Dose Expansion|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014354|NCT01125293|FG005|Participant Flow|Phase II|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014355|NCT01125293|OG000|Outcome|Phase I Stage A Level 1 and 2|"Combination of everolimus & rituximab for 6 cycles:~Level 1:Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Level 2:Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Levels 1 and 2: Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014356|NCT01125293|OG000|Outcome|Phase I Stage B Level 1 & 2 and Dose Expansion|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Level 1: Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Level 2 and Dose Expansion: Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Level 1 & 2 and Dose Expansion: Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Level 1 & 2 and Dose Expansion: Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014357|NCT01125293|OG000|Outcome|Phase I Stage A Level 1|"Combination of everolimus & rituximab for 6 cycles~Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014358|NCT01125293|OG001|Outcome|Phase I Stage A Level 2|"Combination of everolimus & rituximab for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014359|NCT01125293|OG002|Outcome|Phase I Stage B Level 1|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014360|NCT01125293|OG003|Outcome|Phase I Stage B Level 2|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014361|NCT01125293|OG000|Outcome|Phase II|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014362|NCT01125293|OG004|Outcome|Phase I Dose Expansion|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014363|NCT01125293|OG005|Outcome|Phase II|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014364|NCT01125293|EG000|Reported Event|Phase I Stage A Level 1|"Combination of everolimus & rituximab for 6 cycles~Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014365|NCT01125293|EG001|Reported Event|Phase I Stage A Level 2|"Combination of everolimus & rituximab for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)"
11014366|NCT01125293|EG002|Reported Event|Phase I Stage B Level 1|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014367|NCT01125293|EG003|Reported Event|Phase I Stage B Level 2|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014368|NCT01125293|EG004|Reported Event|Phase I Dose Expansion|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11148290|NCT01862796|OG002|Outcome|Lean Weight Maintaining (WMEN)|"Normal weight individuals receiving a weight-maintaining energy needs diet~Weight maintaining diet: Heart healthy weight-maintaining diet"
11148291|NCT01862796|EG000|Reported Event|Obese Underfeeding (UF)|"Obese randomized to received a 35% calorie reduced diet~Underfeeding diet: Heart healthy diet with 35% reduced calories"
11014369|NCT01125293|EG005|Reported Event|Phase II|"Combination of everolimus & rituximab with bortezomib for 6 cycles~Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)~Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)~Bortezomib 1.6 mg/m^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)"
11014370|NCT01125358|BG000|Baseline|10 mg LY2140023|5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
11014371|NCT01125358|BG001|Baseline|80 mg LY2140023|40 mg of LY2140023 orally, twice daily for 6 weeks.
11014372|NCT01125358|BG002|Baseline|160 mg LY2140023|80 mg of LY2140023 orally, twice daily for 6 weeks.
11014373|NCT01125358|BG003|Baseline|Placebo|Placebo orally, twice daily for 6 weeks.
11014374|NCT01125358|BG004|Baseline|Total|Total of all reporting groups
11014375|NCT01125358|FG000|Participant Flow|10 mg LY2140023|5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
11014376|NCT01125358|FG001|Participant Flow|80 mg LY2140023|40 mg of LY2140023 orally, twice daily for 6 weeks.
11014377|NCT01125358|FG002|Participant Flow|160 mg LY2140023|80 mg of LY2140023 orally, twice daily for 6 weeks.
11014378|NCT01125358|FG003|Participant Flow|Placebo|Placebo orally, twice daily for 6 weeks.
11014379|NCT01125358|OG000|Outcome|10 mg LY2140023|5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
11014380|NCT01125358|OG001|Outcome|80 mg LY2140023|40 mg of LY2140023 orally, twice daily for 6 weeks.
11014381|NCT01125358|OG002|Outcome|160 mg LY2140023|80 mg of LY2140023 orally, twice daily for 6 weeks.
11014382|NCT01125358|OG003|Outcome|Placebo|Placebo orally, twice daily for 6 weeks.
11014383|NCT01125358|EG000|Reported Event|10 mg LY2140023|5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
11014384|NCT01125358|EG001|Reported Event|80 mg LY2140023|40 mg of LY2140023 orally, twice daily for 6 weeks.
11014385|NCT01125358|EG002|Reported Event|160 mg LY2140023|80 mg of LY2140023 orally, twice daily for 6 weeks.
11014386|NCT01125358|EG003|Reported Event|Placebo|Placebo orally, twice daily for 6 weeks.
11066113|NCT01390818|OG011|Outcome|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066114|NCT01390818|OG012|Outcome|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066115|NCT01390818|OG013|Outcome|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066116|NCT01390818|OG014|Outcome|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
11066117|NCT01390818|EG000|Reported Event|MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
11066118|NCT01390818|EG001|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
11066119|NCT01390818|EG002|Reported Event|MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
11066120|NCT01390818|EG003|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
11148292|NCT01862796|EG001|Reported Event|Obese Weight Maintaining (WMEN)|"Randomized to receive a weight-maintaining diet~Weight maintaining diet: Heart healthy weight-maintaining diet"
11014387|NCT04733664|BG000|Baseline|Cohort 1|"Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.~VFI using the FAST PV Technology: The bolus IV administered visible fluorescent injectate (VFI) agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11014388|NCT04733664|FG000|Participant Flow|Cohort 1|"Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.~VFI using the FAST PV Technology: The bolus IV administered visible fluorescent injectate (VFI) agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11014389|NCT04733664|OG000|Outcome|Cohort 1|"Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.~VFI using the FAST PV Technology: The bolus IV administered visible fluorescent injectate (VFI) agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11014390|NCT04733664|EG000|Reported Event|Cohort 1|"Patients will receive one dose of visible fluorescent injectate (VFI)™ and one dose of iohexol approximately 4 hours prior to undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after completing dialysis.~VFI using the FAST PV Technology: The bolus IV administered visible fluorescent injectate (VFI) agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11014391|NCT04573322|BG000|Baseline|Lead-in 0.25 mg/kg|"0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014392|NCT04573322|BG001|Baseline|Lead-in 0.50 mg/kg|"0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014393|NCT04573322|BG002|Baseline|Lead-in 1.0 mg/kg|"1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014394|NCT04573322|BG003|Baseline|Lead-in 1.5 mg/kg|"1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014395|NCT04573322|BG004|Baseline|Total|Total of all reporting groups
11014396|NCT04573322|FG000|Participant Flow|Lead-in 0.25 mg/kg|"0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014397|NCT04573322|FG001|Participant Flow|Lead-in 0.50 mg/kg|"0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014398|NCT04573322|FG002|Participant Flow|Lead-in 1.0 mg/kg|"1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014399|NCT04573322|FG003|Participant Flow|Lead-in 1.5 mg/kg|"1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014400|NCT04573322|OG000|Outcome|Lead-in 0.25 mg/kg|"0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014401|NCT04573322|OG001|Outcome|Lead-in 0.50 mg/kg|"0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014402|NCT04573322|OG002|Outcome|Lead-in 1.0 mg/kg|"1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014403|NCT04573322|OG003|Outcome|Lead-in 1.5 mg/kg|"1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
10886167|NCT00492557|BG000|Baseline|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
11014404|NCT04573322|EG000|Reported Event|Lead-in 0.25 mg/kg|"0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014405|NCT04573322|EG001|Reported Event|Lead-in 0.50 mg/kg|"0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014406|NCT04573322|EG002|Reported Event|Lead-in 1.0 mg/kg|"1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014407|NCT04573322|EG003|Reported Event|Lead-in 1.5 mg/kg|"1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days~Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days"
11014408|NCT04516746|BG000|Baseline|AZD1222|Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.
11014409|NCT04516746|BG001|Baseline|Placebo|Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
11014410|NCT04516746|BG002|Baseline|Total|Total of all reporting groups
11014411|NCT04516746|FG000|Participant Flow|AZD1222|Participants were randomized to receive 2 intramuscular (IM) doses of either 5*10^10 viral particles (vp) (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.
11014412|NCT04516746|FG001|Participant Flow|Placebo|Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
11014413|NCT04516746|OG000|Outcome|AZD1222|Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.
11014414|NCT04516746|OG001|Outcome|Placebo|Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
11014415|NCT04516746|EG000|Reported Event|AZD1222|Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.
11014416|NCT04516746|EG001|Reported Event|Placebo|Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
11014417|NCT04374565|BG000|Baseline|Study Participants|"A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.~High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused."
11014418|NCT04374565|FG000|Participant Flow|Study Participants|"A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.~High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused."
11014419|NCT04374565|OG000|Outcome|Study Participants|"A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.~High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused."
11148293|NCT01862796|EG002|Reported Event|Lean Weight Maintaining (WMEN)|"Normal weight individuals receiving a weight-maintaining energy needs diet~Weight maintaining diet: Heart healthy weight-maintaining diet"
11148294|NCT01862874|BG000|Baseline|V501|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
10886168|NCT00492557|BG001|Baseline|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
11014420|NCT04374565|EG000|Reported Event|Study Participants|"A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.~High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused."
11014421|NCT04364737|BG000|Baseline|Convalescent Donor Plasma|Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate
11014422|NCT04364737|BG001|Baseline|Lactated Ringer's Solution or Sterile Saline Solution|Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
11014423|NCT04364737|BG002|Baseline|Total|Total of all reporting groups
11014424|NCT04364737|FG000|Participant Flow|Convalescent Donor Plasma|Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate
11014425|NCT04364737|FG001|Participant Flow|Lactated Ringer's Solution or Sterile Saline Solution|Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
11014426|NCT04364737|OG000|Outcome|Convalescent Donor Plasma|Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate
11014427|NCT04364737|OG001|Outcome|Lactated Ringer's Solution or Sterile Saline Solution|Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
11014428|NCT04364737|EG000|Reported Event|Convalescent Donor Plasma|Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate
11014429|NCT04364737|EG001|Reported Event|Lactated Ringer's Solution or Sterile Saline Solution|Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
11014430|NCT04354155|BG000|Baseline|Thromboprophylaxis|"Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 mg/kg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)~Enoxaparin Prefilled Syringe [Lovenox]: Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)"
11014431|NCT04354155|FG000|Participant Flow|Thromboprophylaxis|"Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 mg/kg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)~Enoxaparin Prefilled Syringe [Lovenox]: Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)"
11014432|NCT04354155|OG000|Outcome|Thromboprophylaxis|"Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 mg/kg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)~Enoxaparin Prefilled Syringe [Lovenox]: Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)"
11014433|NCT04354155|EG000|Reported Event|Thromboprophylaxis|"Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 mg/kg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)~Enoxaparin Prefilled Syringe [Lovenox]: Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)"
11066121|NCT01390818|EG004|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
11066122|NCT01390818|EG005|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
11066123|NCT01390818|EG006|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
11066124|NCT01390818|EG007|Reported Event|MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
11066125|NCT01390818|EG008|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).
11066126|NCT01390818|EG009|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily|MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
11066127|NCT01390818|EG010|Reported Event|MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily|MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
11066128|NCT01390818|EG011|Reported Event|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
11066129|NCT01390818|EG012|Reported Event|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
11066130|NCT01390818|EG013|Reported Event|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
11066131|NCT01390818|EG014|Reported Event|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
11066132|NCT01390844|BG000|Baseline|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
10886169|NCT00492557|BG002|Baseline|Total|Total of all reporting groups
11014434|NCT04085367|BG000|Baseline|MAL 16.8% Cream|Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy [DL-PDT]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
11014435|NCT04085367|BG001|Baseline|MAL Vehicle Cream|Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
11014436|NCT04085367|BG002|Baseline|Total|Total of all reporting groups
11014437|NCT04085367|FG000|Participant Flow|MAL 16.8% Cream|Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy [DL-PDT]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
11014438|NCT04085367|FG001|Participant Flow|MAL Vehicle Cream|Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
11014439|NCT04085367|OG000|Outcome|MAL 16.8% Cream|Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy [DL-PDT]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
11014440|NCT04085367|OG001|Outcome|MAL Vehicle Cream|Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
11014441|NCT04085367|EG000|Reported Event|MAL 16.8% Cream|Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser.
11014442|NCT04085367|EG001|Reported Event|MAL Vehicle Cream|Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser.
11014443|NCT03884270|BG000|Baseline|Hypnotherapy|"7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks)~Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia"
11014444|NCT03884270|FG000|Participant Flow|Hypnotherapy|"7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks)~Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia"
11014445|NCT03884270|OG000|Outcome|Hypnotherapy|"7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks)~Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia"
11014446|NCT03884270|EG000|Reported Event|Hypnotherapy|"7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks)~Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia"
11066133|NCT01390844|BG001|Baseline|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
11066134|NCT01390844|BG002|Baseline|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
11066135|NCT01390844|BG003|Baseline|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
11066136|NCT01390844|BG004|Baseline|Total|Total of all reporting groups
11066137|NCT01390844|FG000|Participant Flow|Boceprevir - Korea+Taiwan|PegIntron (pegylated interferon alfa-2b) (PEG) + ribavirin (RBV) for 4 weeks followed by boceprevir (BOC) + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
11148295|NCT01862874|BG001|Baseline|Placebo|Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
11014447|NCT03621696|BG000|Baseline|Arm 1: POAmCRT|"Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014448|NCT03621696|BG001|Baseline|Arm 2: POAmRT|"Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014449|NCT03621696|BG002|Baseline|Arm 3: POACRT|"Patients with clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)~The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014450|NCT03621696|BG003|Baseline|Not Assigned to an Arm|-Patients were enrolled to the study but deemed ineligible to start treatment and were not enrolled to any arm.
11014451|NCT03621696|BG004|Baseline|Total|Total of all reporting groups
11014452|NCT03621696|FG000|Participant Flow|Arm 1: POAmCRT|"Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014453|NCT03621696|FG001|Participant Flow|Arm 2: POAmRT|"Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014454|NCT03621696|FG002|Participant Flow|Arm 3: POACRT|"Patients with clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)~The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014455|NCT03621696|FG003|Participant Flow|Not Assigned to an Arm|-Patients were enrolled to the study but deemed ineligible to start treatment and were not enrolled to any arm.
11014456|NCT03621696|OG000|Outcome|Arm 1: POAmCRT|"Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014457|NCT03621696|OG001|Outcome|Arm 2: POAmRT|"Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11066138|NCT01390844|FG001|Participant Flow|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
11148296|NCT01862874|BG002|Baseline|Total|Total of all reporting groups
11014458|NCT03621696|OG002|Outcome|Arm 3: POACRT|"Patients with clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)~The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014459|NCT03621696|EG000|Reported Event|Arm 1: POAmCRT|"Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014460|NCT03621696|EG001|Reported Event|Arm 2: POAmRT|"Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014461|NCT03621696|EG002|Reported Event|Arm 3: POACRT|"Patients with clinical or pathologic T4 or clinical N3 disease~Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes~Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)~The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.~It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection~Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study"
11014462|NCT03544268|BG000|Baseline|Acoustic Angiography|"All clinical patients will be included in the experimental group.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent."
11014463|NCT03544268|BG001|Baseline|Image Optimization|"In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent."
11014464|NCT03544268|BG002|Baseline|Total|Total of all reporting groups
11014465|NCT03544268|FG000|Participant Flow|Acoustic Angiography|"All clinical patients will be included in the experimental group.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent."
11014466|NCT03544268|FG001|Participant Flow|Image Optimization|"In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent."
11014467|NCT03544268|OG000|Outcome|Acoustic Angiography|"All clinical patients will be included in the experimental group.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent."
11014468|NCT03544268|OG001|Outcome|Image Optimization|"In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent."
11014469|NCT03544268|EG000|Reported Event|Acoustic Angiography|"All clinical patients will be included in the experimental group.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent."
11014470|NCT03544268|EG001|Reported Event|Image Optimization|"In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent."
11014471|NCT03421197|BG000|Baseline|PPC-06 400 mg QD|"Tepilamide Fumarate 400 mg once per day~PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day"
11014472|NCT03421197|BG001|Baseline|PPC-06 400 mg BID|"Tepilamide Fumarate 400 mg twice per day~PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day"
11014473|NCT03421197|BG002|Baseline|PPC-06 600 mg BID|"Tepilamide Fumarate 600 mg twice per day~PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day"
11014474|NCT03421197|BG003|Baseline|Placebo BID|"White placebo tablet to mimic Tepilamide Fumarate~Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets"
11014475|NCT03421197|BG004|Baseline|Total|Total of all reporting groups
11014476|NCT03421197|FG000|Participant Flow|PPC-06 400 mg QD|"Tepilamide Fumarate 400 mg once per day~PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day"
11014477|NCT03421197|FG001|Participant Flow|PPC-06 400 mg BID|"Tepilamide Fumarate 400 mg twice per day~PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day"
11014478|NCT03421197|FG002|Participant Flow|PPC-06 600 mg BID|"Tepilamide Fumarate 600 mg twice per day~PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day"
11014479|NCT03421197|FG003|Participant Flow|Placebo BID|"White placebo tablet to mimic Tepilamide Fumarate~Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets"
11014480|NCT03421197|OG000|Outcome|PPC-06 400 mg QD|"Tepilamide Fumarate 400 mg once per day~PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day"
11014481|NCT03421197|OG001|Outcome|PPC-06 400 mg BID|"Tepilamide Fumarate 400 mg twice per day~PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day"
11014482|NCT03421197|OG002|Outcome|PPC-06 600 mg BID|"Tepilamide Fumarate 600 mg twice per day~PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day"
11014483|NCT03421197|OG003|Outcome|Placebo BID|"White placebo tablet to mimic Tepilamide Fumarate~Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets"
11014484|NCT03421197|EG000|Reported Event|PPC-06 400 mg QD|"Tepilamide Fumarate 400 mg once per day~PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day"
11014485|NCT03421197|EG001|Reported Event|PPC-06 400 mg BID|"Tepilamide Fumarate 400 mg twice per day~PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day"
11014486|NCT03421197|EG002|Reported Event|PPC-06 600 mg BID|"Tepilamide Fumarate 600 mg twice per day~PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day"
11014487|NCT03421197|EG003|Reported Event|Placebo BID|"White placebo tablet to mimic Tepilamide Fumarate~Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets"
11014488|NCT03371108|BG000|Baseline|Gan & Lee Insulin Glargine Injection|"Gan & Lee Insulin Glargine Injection solution for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0 mL prefilled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks.~Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection"
11014489|NCT03371108|BG001|Baseline|Lantus®|"Lantus® solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL prefilled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.~Lantus®: Route of administration: subcutaneous injection"
11014490|NCT03371108|BG002|Baseline|Total|Total of all reporting groups
11014491|NCT03371108|FG000|Participant Flow|Gan & Lee Insulin Glargine Injection|"Gan & Lee Insulin Glargine Injection solution for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0 mL prefilled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks.~Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection"
11014492|NCT03371108|FG001|Participant Flow|Lantus®|"Lantus® solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL prefilled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.~Lantus®: Route of administration: subcutaneous injection"
11014493|NCT03371108|OG000|Outcome|Gan & Lee Insulin Glargine Injection|"Gan & Lee Insulin Glargine Injection solution for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0 mL prefilled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks.~Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection"
11014494|NCT03371108|OG001|Outcome|Lantus®|"Lantus® solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL prefilled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.~Lantus®: Route of administration: subcutaneous injection"
11014495|NCT03371108|EG000|Reported Event|Gan & Lee Insulin Glargine Injection|"Gan & Lee Insulin Glargine Injection solution for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0 mL prefilled Gan & Lee injector pen. Subjects randomized to the Gan & Lee Insulin Glargine Injection group will participate in the study for 26 weeks.~Gan & Lee Insulin Glargine Injection: Route of administration: subcutaneous injection"
11014496|NCT03371108|EG001|Reported Event|Lantus®|"Lantus® solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL prefilled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.~Lantus®: Route of administration: subcutaneous injection"
11014497|NCT03112993|BG000|Baseline|Sugammadex Group|"2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight.~sugammadex: once at the end of the surgery"
11014498|NCT03112993|BG001|Baseline|Neostigmine Group|"50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery.~Dosing will be based on actual body weight not ideal body weight.~Neostigmine: once at the end of the surgery"
11014499|NCT03112993|BG002|Baseline|Total|Total of all reporting groups
11014500|NCT03112993|FG000|Participant Flow|Sugammadex Group|"2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight.~sugammadex: once at the end of the surgery"
11014501|NCT03112993|FG001|Participant Flow|Neostigmine Group|"50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery.~Dosing will be based on actual body weight not ideal body weight.~Neostigmine: once at the end of the surgery"
11014502|NCT03112993|OG000|Outcome|Sugammadex Group|"2 mg/kg of sugammadex, IV once at the end of the surgery.~Dosing will be based on actual body weight not ideal body weight.~sugammadex: once at the end of the surgery"
11014503|NCT03112993|OG001|Outcome|Neostigmine Group|"50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery.~Dosing will be based on actual body weight not ideal body weight.~Neostigmine: once at the end of the surgery"
11014504|NCT03112993|OG000|Outcome|Sugammadex Group|"2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight.~sugammadex: once at the end of the surgery"
11014505|NCT03112993|OG000|Outcome|Sugammadex Group|"2 mg/kg of sugammadex, IV once at the end of the surgery.~Dosing will be based on actual body weight not ideal body weight.~Sugammadex: once at the end of the surgery"
11014506|NCT03112993|EG000|Reported Event|Sugammadex Group|"2 mg/kg of sugammadex, IV once at the end of the surgery.~Dosing will be based on actual body weight not ideal body weight.~Sugammadex: once at the end of the surgery"
11014507|NCT03112993|EG001|Reported Event|Neostigmine Group|"50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery.~Dosing will be based on actual body weight not ideal body weight.~Neostigmine: once at the end of the surgery"
11014508|NCT03088137|BG000|Baseline|Primapur (Follitropin Alfa)|Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
11014509|NCT03088137|BG001|Baseline|Gonal-f (Follitropin Alfa)|Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
11014510|NCT03088137|BG002|Baseline|Total|Total of all reporting groups
11014511|NCT03088137|FG000|Participant Flow|Primapur (Follitropin Alfa)|Follitropin alfa (Primapur): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
11014512|NCT03088137|FG001|Participant Flow|Gonal-f (Follitropin Alfa)|Follitropin alfa (Gonal-f): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
11014513|NCT03088137|OG000|Outcome|Primapur (Follitropin Alfa)|Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
11014514|NCT03088137|OG001|Outcome|Gonal-f (Follitropin Alfa)|Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
11014515|NCT03088137|EG000|Reported Event|Primapur (Follitropin Alfa)|Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
11014516|NCT03088137|EG001|Reported Event|Gonal-f (Follitropin Alfa)|Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
11014517|NCT03038438|BG000|Baseline|ABRE|Subjects included and implanted with one or more Abre stents
11014518|NCT03038438|FG000|Participant Flow|ABRE|Subjects implanted with one or more Abre stents.
11014519|NCT03038438|OG000|Outcome|ABRE|Subjects implanted with one or more Abre stents.
11014520|NCT03038438|EG000|Reported Event|ABRE|Subjects implanted with one or more Abre stents.
11014521|NCT02951481|BG000|Baseline|Retrospective Historic Cohort.|Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
11014522|NCT02951481|BG001|Baseline|Intervention Group (Prospective)|"Patients diagnosed with a first episode of CDI in the University Hospital 12 de Octubre, Madrid, Spain, requiring hospitalization or emergency room admission longer than 48 hours, from the beginning of the study on (1-February-2017). An intervention was made."
11014523|NCT02951481|BG002|Baseline|Total|Total of all reporting groups
11014524|NCT02951481|FG000|Participant Flow|Retrospective Historic Cohort|During 2015 (12 months), there were 231 patients with a first episode of CDI.
11014525|NCT02951481|FG001|Participant Flow|Prospective Group|"Patients diagnosed with a first episode of CDI in the University Hospital 12 de Octubre, Madrid, Spain, requiring hospitalization or emergency room admission longer than 48 hours, from the beginning of the study on (1-February-2017). From February 15, 2017 to December 15, 2017 (10 months) there were 172 patients diagnosed with with a first episode of CDI."
11014526|NCT02951481|OG000|Outcome|Retrospective Historic Cohort.|Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
11014527|NCT02951481|OG001|Outcome|Intervention Group (Prospective)|"Patients diagnosed with a first episode of CDI in the University Hospital 12 de Octubre, Madrid, Spain, requiring hospitalization or emergency room admission longer than 48 hours, from the beginning of the study on (1-February-2017). An intervention was made."
11014528|NCT02951481|EG000|Reported Event|Retrospective Historic Cohort.|Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
11014529|NCT02951481|EG001|Reported Event|Intervention Group (Prospective)|"Patients diagnosed with a first episode of CDI in the University Hospital 12 de Octubre, Madrid, Spain, requiring hospitalization or emergency room admission longer than 48 hours, from the beginning of the study on (1-February-2017). An intervention was made."
11014530|NCT02451943|BG000|Baseline|Doxorubicin + Olaratumab|75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
11148297|NCT01862874|FG000|Participant Flow|V501|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
11014531|NCT02451943|BG001|Baseline|Doxorubicin + Placebo|75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
11014532|NCT02451943|BG002|Baseline|Total|Total of all reporting groups
11014533|NCT02451943|FG000|Participant Flow|Doxorubicin + Olaratumab|75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle up to 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle thereafter until documented progressive disease (PD) or discontinuation for any other reason.
11014534|NCT02451943|FG001|Participant Flow|Doxorubicin + Placebo|75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle up to 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle thereafter until PD or discontinuation for any other reason.
11014535|NCT02451943|OG000|Outcome|Doxorubicin + Olaratumab|75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
11014536|NCT02451943|OG001|Outcome|Doxorubicin + Placebo|75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
11014537|NCT02451943|EG000|Reported Event|Doxorubicin + Olaratumab|75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
11014538|NCT02451943|EG001|Reported Event|Doxorubicin + Placebo|75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
11066139|NCT01390844|FG002|Participant Flow|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
11066140|NCT01390844|FG003|Participant Flow|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
11066141|NCT01390844|OG000|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
11066142|NCT01390844|OG001|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
11066143|NCT01390844|OG000|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
11066144|NCT01390844|OG001|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
11148298|NCT01862874|FG001|Participant Flow|Placebo|Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
11148299|NCT01862874|OG000|Outcome|V501|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
11148300|NCT01862874|OG001|Outcome|Placebo|Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
11014554|NCT02198794|BG000|Baseline|SD-809|Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.
11014555|NCT02198794|FG000|Participant Flow|SD-809|Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.
11014556|NCT02198794|FG001|Participant Flow|Part B: Placebo|Participants received placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks.
11014557|NCT02198794|FG002|Participant Flow|Part B: SD-809|Participants received SD-809 (stable dose) for 1 week in randomized withdrawal period and continued to receive the same dose of SD-809 for an additional 12 weeks.
11014558|NCT02198794|FG003|Participant Flow|Part C: SD-809|EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B.
11014559|NCT02198794|OG000|Outcome|SD-809|Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.
11014560|NCT02198794|OG001|Outcome|Part C: SD-809|EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B.
11014561|NCT02198794|OG000|Outcome|Part B: Placebo|Participants received placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks.
11014562|NCT02198794|OG001|Outcome|Part B: SD-809|Participants received SD-809 (stable dose) for 1 week in randomized withdrawal period and continued to receive the same dose of SD-809 for an additional 12 weeks.
11014563|NCT02198794|OG000|Outcome|Part A: SD-809|Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.
11014564|NCT02198794|EG000|Reported Event|Part A and Part B Participants|Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158. Participants who agreed to participate in Part B, received SD-809 or placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks.
11014565|NCT02198794|EG001|Reported Event|Part C: SD-809|EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B.
11014566|NCT01877655|BG000|Baseline|Placebo|Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
11014567|NCT01877655|BG001|Baseline|ASP0113|Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
11014568|NCT01877655|BG002|Baseline|Total|Total of all reporting groups
11014569|NCT01877655|FG000|Participant Flow|Placebo|Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
11148301|NCT01862874|EG000|Reported Event|V501|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
11014570|NCT01877655|FG001|Participant Flow|ASP0113 5mg|Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
11014571|NCT01877655|OG000|Outcome|Placebo|Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
11014572|NCT01877655|OG001|Outcome|ASP0113|Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
11014573|NCT01877655|EG000|Reported Event|Placebo|Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
11014574|NCT01877655|EG001|Reported Event|ASP0113 5mg|Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
11014575|NCT00308685|BG000|Baseline|Albuterol-HFA-BAI|Participants received albuterol
11014576|NCT00308685|BG001|Baseline|Placebo-HFA-BAI|Participants received placebo
11014577|NCT00308685|BG002|Baseline|Total|Total of all reporting groups
11014578|NCT00308685|FG000|Participant Flow|Albuterol-HFA-BAI|Participants received albuterol
11014579|NCT00308685|FG001|Participant Flow|Placebo-HFA-BAI|Participants received placebo
11014580|NCT00308685|OG000|Outcome|Albuterol-HFA-BAI|Participants received albuterol
11014581|NCT00308685|OG001|Outcome|Placebo-HFA-BAI|Participants received placebo
11014582|NCT00308685|EG000|Reported Event|Albuterol-HFA-BAI|Participants received albuterol
11014583|NCT00308685|EG001|Reported Event|Placebo-HFA-BAI|Participants received placebo
11014584|NCT01125514|BG000|Baseline|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.~Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.~Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.~Day 28, no study treatment."
11014585|NCT01125514|FG000|Participant Flow|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.~Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.~Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.~Day 28, no study treatment."
11014586|NCT01125514|OG000|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
11014587|NCT01125514|OG001|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
11014588|NCT01125514|OG002|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
11014589|NCT01125514|OG003|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
11014590|NCT01125514|OG001|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
11014591|NCT01125514|OG002|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
10887260|NCT00499486|FG000|Participant Flow|Sirolimus|Patients with advanced pancreatic adenocarcinoma refractory to gemcitibine received Sirolimus at a single oral flat dose of 5 mg. per day. A treatment cycle was 28 days.
11014592|NCT01125514|OG003|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
11014593|NCT01125514|OG001|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
11014594|NCT01125514|OG002|Outcome|Furosemide go mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
11014595|NCT01125514|EG000|Reported Event|60 mg Furosemide + 150 mg Placebo + 300 mg Placebo|60 mg furosemide + 150 mg placebo + 300 mg placebo
11014596|NCT01125514|EG001|Reported Event|60 mg Furosemide + 150 mg Aliskiren + 300 mg Placebo|60 mg furosemide + 150 mg aliskiren + 300 mg placebo
11014597|NCT01125514|EG002|Reported Event|60 mg Furosemide + 300 mg Aliskiren + 150 mg Placebo|60 mg furosemide + 300 mg aliskiren + 150 mg placebo
11014598|NCT01125566|BG000|Baseline|Afatinib + Vinorelbine (AV)|Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.
11014599|NCT01125566|BG001|Baseline|Trastuzumab + Vinorelbine (TV)|Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.
11014600|NCT01125566|BG002|Baseline|Total|Total of all reporting groups
11148302|NCT01862874|EG001|Reported Event|Placebo|Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
11342106|NCT03697083|OG001|Outcome|Active Control Arm|"Participants will be asked to think about where they will store their prescription.~Active Control: Participants receive 8 text messages asking them to think of where they plan to store their medication once they pick it up and to think about that location on their intended date of pickup."
11014601|NCT01125566|FG000|Participant Flow|Afatinib + Vinorelbine (AV)|Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.
11014602|NCT01125566|FG001|Participant Flow|Trastuzumab + Vinorelbine (TV)|Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.
11014603|NCT01125566|FG002|Participant Flow|AV Switched to TV|This group describes participants who discontinued AV treatment and switched to TV, provided they were without disease progression on AV, following data monitoring committee (DMC) recommendation to terminate recruitment on 26 April 2013.
11014604|NCT01125566|OG000|Outcome|Afatinib + Vinorelbine (AV)|Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.
11014605|NCT01125566|OG001|Outcome|Trastuzumab + Vinorelbine (TV)|Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.
11014606|NCT01125566|EG000|Reported Event|Afatinib + Vinorelbine (AV)|Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.
11014607|NCT01125566|EG001|Reported Event|Trastuzumab + Vinorelbine (TV)|Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.
11014608|NCT01125566|EG002|Reported Event|AV Switched to TV|This group describes participants who discontinued AV treatment and switched to TV, provided they were without disease progression on AV, following data monitoring committee (DMC) recommendation to terminate recruitment on 26 April 2013.
11014609|NCT01125605|BG000|Baseline|Observational Group|Pasconal Nerventropfen
11014610|NCT01125605|FG000|Participant Flow|Observational Group|Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula.
11014611|NCT01125605|OG000|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
11014612|NCT01125605|OG001|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
11014613|NCT01125605|OG002|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
11014614|NCT01125605|OG003|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
11014615|NCT01125605|OG001|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
11014616|NCT01125605|OG000|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
11014617|NCT01125605|OG001|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
11014618|NCT01125605|OG000|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
11014619|NCT01125605|OG001|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
11014620|NCT01125605|OG002|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
11014621|NCT01125605|OG000|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with concomitant medication
11014622|NCT01125605|OG001|Outcome|>= 4 Weeks|Observational group (Pasconal Nerventropfen) without concomitant medication
11014623|NCT01125605|OG000|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
11014624|NCT01125605|OG001|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
11014625|NCT01125605|EG000|Reported Event|Observational Group|Pasconal Nerventropfen
11014626|NCT01125722|BG000|Baseline|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
11014627|NCT01125722|BG001|Baseline|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
11014628|NCT01125722|BG002|Baseline|Total|Total of all reporting groups
11014629|NCT01125722|FG000|Participant Flow|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
11014630|NCT01125722|FG001|Participant Flow|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
11014631|NCT01125722|OG000|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
11014632|NCT01125722|OG001|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
11014633|NCT01125722|EG000|Reported Event|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
11342107|NCT03697083|OG002|Outcome|Baseline Control Arm|"Participants are thanked for enrolling in the reminder program.~Baseline Control: Participants receive 1 text message thanking participants for enrolling in the reminder program. Participants are not contacted further."
11014634|NCT01125722|EG001|Reported Event|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
11014635|NCT01125748|BG000|Baseline|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
11014636|NCT01125748|BG001|Baseline|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
11014637|NCT01125748|BG002|Baseline|Total|Total of all reporting groups
11014638|NCT01125748|FG000|Participant Flow|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
11014639|NCT01125748|FG001|Participant Flow|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
11014640|NCT01125748|OG000|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
11014641|NCT01125748|OG001|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
11014642|NCT01125748|EG000|Reported Event|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
11014643|NCT01125748|EG001|Reported Event|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
11014644|NCT01125774|BG000|Baseline|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014645|NCT01125774|BG001|Baseline|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014646|NCT01125774|BG002|Baseline|Total|Total of all reporting groups
11014647|NCT01125774|FG000|Participant Flow|Telcagepant 140 mg - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to telcagepant. Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014648|NCT01125774|FG001|Participant Flow|Placebo - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014649|NCT01125774|FG002|Participant Flow|Telcagepant 140 mg - Duplicate Participants|Participants who were randomized at more than 1 study site and were randomized at least once to telcagepant and may also have been randomized to placebo. Study drug was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014650|NCT01125774|FG003|Participant Flow|Placebo - Duplicate Participants|Participants who were randomized at more than 1 study site and each time were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014651|NCT01125774|OG000|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014652|NCT01125774|OG001|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014653|NCT01125774|EG000|Reported Event|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014654|NCT01125774|EG001|Reported Event|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
11014655|NCT01125800|BG000|Baseline|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
11014656|NCT01125800|BG001|Baseline|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
11014657|NCT01125800|BG002|Baseline|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
11014658|NCT01125800|BG003|Baseline|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
11014659|NCT01125800|BG004|Baseline|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
11014660|NCT01125800|BG005|Baseline|Total|Total of all reporting groups
11014661|NCT01125800|FG000|Participant Flow|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
11014662|NCT01125800|FG001|Participant Flow|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
11014663|NCT01125800|FG002|Participant Flow|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
11014664|NCT01125800|FG003|Participant Flow|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route. The Phase I , Phase II patients are pooled and summarized by dose levels. One pediatric patient enrolled in the Phase II portion at the 680 mg/m2 dose was pooled with 21 pediatric patients enrolled in Phase I at the same dose
11014665|NCT01125800|FG004|Participant Flow|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
11014666|NCT01125800|OG000|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
11014667|NCT01125800|OG001|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
11014668|NCT01125800|OG002|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
11014669|NCT01125800|OG003|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
11014670|NCT01125800|OG000|Outcome|All Participants|All participants received LDE225 233, 372, 425, 680, 800 mg/m^2 once daily through oral route until disease progression, unacceptable toxicity, or consent withdrawal.
11014671|NCT01125800|OG004|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
11014672|NCT01125800|OG000|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
11014673|NCT01125800|OG001|Outcome|Adult Participants|All adult Participants were treated with sonidegib 800 mg once daily in phase II portion of the study. Pediatric patients were also enrolled in phase II portion of the study at the recommended phase II pediatric dose - 680 mg/m^2
11014674|NCT01125800|EG000|Reported Event|Pediatric Participants, LDE225 233 mg/m^2|Pediatric participants received LDE225 233 mg/m^2 once daily through oral route.
11014675|NCT01125800|EG001|Reported Event|Pediatric Participants, LDE225 372 mg/m^2|Pediatric participants received LDE225 372 mg/m^2 once daily through oral route.
11014676|NCT01125800|EG002|Reported Event|Pediatric Participants, LDE225 425 mg/m^2|Pediatric participants received LDE225 425 mg/m^2 once daily through oral route.
11014677|NCT01125800|EG003|Reported Event|Pediatric Participants, LDE225 680 mg/m^2|Pediatric participants received LDE225 680 mg/m^2 once daily through oral route.
11014678|NCT01125800|EG004|Reported Event|Adult Participants, LDE225 800 mg|Adult participants were treated with LDE225 800 mg capsule once daily.
11014679|NCT01125813|BG000|Baseline|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
11014680|NCT01125813|FG000|Participant Flow|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
11014681|NCT01125813|OG000|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
11014682|NCT01125813|EG000|Reported Event|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
11014683|NCT01125917|BG000|Baseline|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
11014684|NCT01125917|FG000|Participant Flow|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
11014685|NCT01125917|OG000|Outcome|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
11014686|NCT01125917|EG000|Reported Event|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
11014687|NCT01125930|BG000|Baseline|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
10887261|NCT00499486|OG000|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
11014688|NCT01125930|BG001|Baseline|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014689|NCT01125930|BG002|Baseline|Total|Total of all reporting groups
11014690|NCT01125930|FG000|Participant Flow|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014691|NCT01125930|FG001|Participant Flow|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014692|NCT01125930|OG000|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014693|NCT01125930|OG001|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014694|NCT01125930|OG000|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014695|NCT01125930|OG001|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014696|NCT01125930|OG002|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014697|NCT01125930|OG003|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014698|NCT01125930|OG004|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014699|NCT01125930|OG005|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014700|NCT01125930|OG006|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
10886170|NCT00492557|FG000|Participant Flow|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
11014701|NCT01125930|OG007|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014702|NCT01125930|OG008|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014703|NCT01125930|OG009|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014704|NCT01125930|OG000|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014705|NCT01125930|OG000|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014706|NCT01125930|OG002|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014707|NCT01125930|OG004|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014708|NCT01125930|OG006|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014709|NCT01125930|OG008|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014710|NCT01125930|EG000|Reported Event|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
11014711|NCT01125930|EG001|Reported Event|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
11014712|NCT01126060|BG000|Baseline|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
11014713|NCT01126060|BG001|Baseline|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
11014714|NCT01126060|BG002|Baseline|Total|Total of all reporting groups
11014715|NCT01126060|FG000|Participant Flow|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
11014716|NCT01126060|FG001|Participant Flow|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
11014717|NCT01126060|OG000|Outcome|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
11014718|NCT01126060|OG001|Outcome|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
11014719|NCT01126060|EG000|Reported Event|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
11014720|NCT01126060|EG001|Reported Event|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
11014721|NCT01126099|BG000|Baseline|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
11014722|NCT01126099|BG001|Baseline|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
11014723|NCT01126099|BG002|Baseline|Total|Total of all reporting groups
11014724|NCT01126099|FG000|Participant Flow|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
11014725|NCT01126099|FG001|Participant Flow|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
11014726|NCT01126099|OG000|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
11014727|NCT01126099|OG001|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
11014728|NCT01126099|EG000|Reported Event|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
11014729|NCT01126099|EG001|Reported Event|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
11014730|NCT01126268|BG000|Baseline|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
11014731|NCT01126268|FG000|Participant Flow|Retapamulin Ointment 1% Group|Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.
11014732|NCT01126268|OG000|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
11014733|NCT01126268|EG000|Reported Event|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
11014734|NCT01126359|BG000|Baseline|All Study Participants|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa.
11014735|NCT01126359|FG000|Participant Flow|Lidocaine Then Placebo-Saline|Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. Then, control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube.
11014736|NCT01126359|FG001|Participant Flow|Placebo-Saline Then Lidocaine|Control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube. Then, interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
11014737|NCT01126359|OG000|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
11014738|NCT01126359|OG001|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
11014739|NCT01126359|OG002|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline VAS difference for each participant. A negative VAS difference indicates a reduction in the level of pain with Lidocaine compared to Placebo-Saline utilizing crossover intervention.
11014740|NCT01126359|OG002|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Each patient narcotic requirements are determined at each measured time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline difference (mg). A negative narcotic requirement difference indicates a reduction in medication dosed (mg) used during and after VAC dressing change in a crossover intervention technique.
11014741|NCT01126359|EG000|Reported Event|First Intervention (Lidocaine)|
11014742|NCT01126359|EG001|Reported Event|First Intervention (Placebo)|
11014743|NCT01126359|EG002|Reported Event|Second Intervention (Placebo)|
11014744|NCT01126359|EG003|Reported Event|Second Intervention (Lidocaine)|
11014745|NCT01126424|BG000|Baseline|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
11014746|NCT01126424|BG001|Baseline|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
11014747|NCT01126424|BG002|Baseline|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
11014748|NCT01126424|BG003|Baseline|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
11014749|NCT01126424|BG004|Baseline|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
11014750|NCT01126424|BG005|Baseline|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
11014751|NCT01126424|BG006|Baseline|Total|Total of all reporting groups
11014752|NCT01126424|FG000|Participant Flow|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
11014753|NCT01126424|FG001|Participant Flow|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
11014754|NCT01126424|FG002|Participant Flow|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
11014755|NCT01126424|FG003|Participant Flow|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
11014756|NCT01126424|FG004|Participant Flow|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
11014757|NCT01126424|FG005|Participant Flow|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
11014758|NCT01126424|OG000|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
11014759|NCT01126424|OG001|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
11014760|NCT01126424|OG002|Outcome|Placebo|Participants received 21 days of treatment with placebo.
11014761|NCT01126424|EG000|Reported Event|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
11014762|NCT01126424|EG001|Reported Event|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
11014763|NCT01126424|EG002|Reported Event|Placebo|Participants received 21 days of treatment with placebo.
11014764|NCT01126437|BG000|Baseline|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
11014765|NCT01126437|BG001|Baseline|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
11014766|NCT01126437|BG002|Baseline|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
11014767|NCT01126437|BG003|Baseline|Total|Total of all reporting groups
11014768|NCT01126437|FG000|Participant Flow|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
11014769|NCT01126437|FG001|Participant Flow|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
11014770|NCT01126437|FG002|Participant Flow|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
11014771|NCT01126437|OG000|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
11014772|NCT01126437|OG001|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
11014773|NCT01126437|OG002|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
11014774|NCT01126437|EG000|Reported Event|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
11014775|NCT01126437|EG001|Reported Event|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
11014776|NCT01126437|EG002|Reported Event|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~Tiotropium 18 mcg: HandiHaler"
11014777|NCT01126541|BG000|Baseline|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
11014778|NCT01126541|BG001|Baseline|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
11014779|NCT01126541|BG002|Baseline|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
11014780|NCT01126541|BG003|Baseline|Total|Total of all reporting groups
11014781|NCT01126541|FG000|Participant Flow|Randomized Retreatment Arm A: Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) on Days 1 and 15. After Week 24, if Disease Activity Score based on 28-Joint Count (DAS28) was greater than (>)3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and methotrexate (MTX) ≥10 milligrams per week (mg/week) by mouth or parenteral throughout course of treatment.
11014782|NCT01126541|FG001|Participant Flow|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
11014783|NCT01126541|FG002|Participant Flow|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
11014784|NCT01126541|OG000|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
11014785|NCT01126541|OG001|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
11014786|NCT01126541|OG000|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
11014787|NCT01126541|OG001|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
11014788|NCT01126541|OG000|Outcome|Randomized Re-treatment Arm A: Single 1000 mg IV Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
11014789|NCT01126541|EG000|Reported Event|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
11014790|NCT01126541|EG001|Reported Event|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
11014791|NCT01126541|EG002|Reported Event|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
11014792|NCT01126580|BG000|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014793|NCT01126580|BG001|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014794|NCT01126580|BG002|Baseline|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
11014795|NCT01126580|BG003|Baseline|Total|Total of all reporting groups
11342108|NCT03697083|EG000|Reported Event|Reminders Through Association Arm|"participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription.~Reminders Through Association: Participants receive 8 text messages asking them to think of a reminder cue that will help them remember to pick up the prescription and use the cue."
11014796|NCT01126580|FG000|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014797|NCT01126580|FG001|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014798|NCT01126580|FG002|Participant Flow|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
11014799|NCT01126580|OG000|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014800|NCT01126580|OG001|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014801|NCT01126580|OG002|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
11014802|NCT01126580|OG000|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014803|NCT01126580|EG000|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014804|NCT01126580|EG001|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
11014805|NCT01126580|EG002|Reported Event|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
11014806|NCT01126593|BG000|Baseline|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
10886171|NCT00492557|FG001|Participant Flow|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
11014807|NCT01126593|BG001|Baseline|Control Group|The control group patients will receive no continuous infusion catheter.
11014808|NCT01126593|BG002|Baseline|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
11014809|NCT01126593|BG003|Baseline|Total|Total of all reporting groups
11014810|NCT01126593|FG000|Participant Flow|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
11014811|NCT01126593|FG001|Participant Flow|Control Group|The control group patients will receive no continuous infusion catheter.
11014812|NCT01126593|FG002|Participant Flow|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
11014813|NCT01126593|OG000|Outcome|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
11014814|NCT01126593|OG001|Outcome|Control Group|The control group patients will receive no continuous infusion catheter.
11014815|NCT01126593|OG002|Outcome|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
11014816|NCT01126593|EG000|Reported Event|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
11014817|NCT01126593|EG001|Reported Event|Control Group|The control group patients will receive no continuous infusion catheter.
11014818|NCT01126593|EG002|Reported Event|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
11014819|NCT01126619|BG000|Baseline|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
11014820|NCT01126619|FG000|Participant Flow|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
11014821|NCT01126619|OG000|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
11014822|NCT01126619|OG000|Outcome|Baseline|Baseline Static Physician Global Assessment of Psoriasis, prior to initiation of anti-TNF therapy.
11014823|NCT01126619|OG001|Outcome|Week 24|Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
11014824|NCT01126619|EG000|Reported Event|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
11014825|NCT01126671|BG000|Baseline|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
11014826|NCT01126671|BG001|Baseline|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
11014827|NCT01126671|BG002|Baseline|Total|Total of all reporting groups
11014828|NCT01126671|FG000|Participant Flow|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
11014829|NCT01126671|FG001|Participant Flow|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
11014830|NCT01126671|OG000|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
11014831|NCT01126671|OG001|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
11014832|NCT01126671|OG000|Outcome|Low Dose Vitamin D|"Subjects are randomized to take 200 IU vitamin D3 daily in this arm.~Supplemental Vitamin D: Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after."
11014833|NCT01126671|OG001|Outcome|High Dose Vitamin D|"Subjects are randomized to take 1000 IU vitamin D3 daily in this arm.~Supplemental Vitamin D: Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after."
11014834|NCT01126671|EG000|Reported Event|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
11014835|NCT01126671|EG001|Reported Event|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
11014836|NCT01126723|BG000|Baseline|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
11014837|NCT01126723|BG001|Baseline|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
11014838|NCT01126723|BG002|Baseline|Total|Total of all reporting groups
11014839|NCT01126723|FG000|Participant Flow|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
11014840|NCT01126723|FG001|Participant Flow|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
11014841|NCT01126723|OG000|Outcome|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
11014842|NCT01126723|OG001|Outcome|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
11014843|NCT01126723|EG000|Reported Event|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
11014844|NCT01126723|EG001|Reported Event|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
11014845|NCT01127061|BG000|Baseline|Exercise Training|Participants in the exercise group will be follow an individualized moderate-intensity exercise prescription (designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test). Exercise regimen will begin at a low level of intensity (3 sessions per week, 20 minutes per session, at a heart rate corresponding to 60% of heart rate reserve), then increase in duration and training intensity to a goal of up to 60 minutes per session, 4 to 7 sessions per week, at 70% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter. No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise.
11014846|NCT01127061|BG001|Baseline|Usual Activity|Participants in this group are not restricted in their activities. They simply are not guided in their physical activities by the study team. At the end of the 4-month study period, they will also receive an individualized exercise prescription for personal use.
11014847|NCT01127061|BG002|Baseline|Total|Total of all reporting groups
11014848|NCT01127061|FG000|Participant Flow|Exercise Training|Participants in the exercise group will be follow an individualized moderate-intensity exercise prescription (designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test). Exercise regimen will begin at a low level of intensity (3 sessions per week, 20 minutes per session, at a heart rate corresponding to 60% of heart rate reserve), then increase in duration and training intensity to a goal of up to 60 minutes per session, 4 to 7 sessions per week, at 70% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter. No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise.
11014849|NCT01127061|FG001|Participant Flow|Usual Activity|Participants in this group are not restricted in their activities. They simply are not guided in their physical activities by the study team. At the end of the 4 month study period, they will also receive an individualized exercise prescription for personal use.
11014850|NCT01127061|OG000|Outcome|Exercise Training|Participants in the exercise group will be follow an individualized moderate-intensity exercise prescription (designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test). Exercise regimen will begin at a low level of intensity (3 sessions per week, 20 minutes per session, at a heart rate corresponding to 60% of heart rate reserve), then increase in duration and training intensity to a goal of up to 60 minutes per session, 4 to 7 sessions per week, at 70% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter. No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise.
11014851|NCT01127061|OG001|Outcome|Usual Activity|Participants in this group are not restricted in their activities. They simply are not guided in their physical activities by the study team. At the end of the 4-month study period, they will also receive an individualized exercise prescription for personal use.
11342109|NCT03697083|EG001|Reported Event|Active Control Arm|"Participants will be asked to think about where they will store their prescription.~Active Control: Participants receive 8 text messages asking them to think of where they plan to store their medication once they pick it up and to think about that location on their intended date of pickup."
11342110|NCT03697083|EG002|Reported Event|Baseline Control Arm|"Participants are thanked for enrolling in the reminder program.~Baseline Control: Participants receive 1 text message thanking participants for enrolling in the reminder program. Participants are not contacted further."
11342111|NCT03697122|BG000|Baseline|HHBC and Forced Air Warming|"Patients admitted to intensive care unit hypothermic (≤ 35 C) following surgical procedures involving cardiopulmonary bypass. Will be rewarmed with heated humidified breathing circuits (ANAPOD) and standard forced air warming blankets.~Heated Humidified Breathing Circuit and Forced Air Blanket: Heated humidified breathing circuits (ANAPOD) will be set up and managed by respiratory therapist in standard fashion defined by the manufacturer. Temperate will be set at 41C.~Forced air warming blankets will be set at 42C for duration of rewarming."
11014852|NCT01127061|EG000|Reported Event|Exercise Training|Participants in the exercise group will be follow an individualized moderate-intensity exercise prescription (designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test). Exercise regimen will begin at a low level of intensity (3 sessions per week, 20 minutes per session, at a heart rate corresponding to 60% of heart rate reserve), then increase in duration and training intensity to a goal of up to 60 minutes per session, 4 to 7 sessions per week, at 70% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter. No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise.
11014853|NCT01127061|EG001|Reported Event|Usual Activity|Participants in this group are not restricted in their activities. They simply are not guided in their physical activities by the study team. At the end of the 4-month study period, they will also receive an individualized exercise prescription for personal use.
11014854|NCT01127087|BG000|Baseline|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014855|NCT01127087|BG001|Baseline|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014856|NCT01127087|BG002|Baseline|Total|Total of all reporting groups
11014857|NCT01127087|FG000|Participant Flow|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014858|NCT01127087|FG001|Participant Flow|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014859|NCT01127087|OG000|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014860|NCT01127087|OG001|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014861|NCT01127087|OG000|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014862|NCT01127087|OG001|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014863|NCT01127087|EG000|Reported Event|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014864|NCT01127087|EG001|Reported Event|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
11014865|NCT01127139|BG000|Baseline|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
11014866|NCT01127139|FG000|Participant Flow|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
11014867|NCT01127139|OG000|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
10886172|NCT00492557|OG000|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
11014868|NCT01127139|OG001|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
11014869|NCT01127139|OG002|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
11014870|NCT01127139|OG000|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
11014871|NCT01127139|EG000|Reported Event|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
11014872|NCT01127165|BG000|Baseline|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
11014873|NCT01127165|BG001|Baseline|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
11014874|NCT01127165|BG002|Baseline|Total|Total of all reporting groups
11014875|NCT01127165|FG000|Participant Flow|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
11014876|NCT01127165|FG001|Participant Flow|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
11014877|NCT01127165|OG000|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
11014878|NCT01127165|OG001|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
11014879|NCT01127165|EG000|Reported Event|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
11014880|NCT01127165|EG001|Reported Event|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
11014881|NCT01127321|BG000|Baseline|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
11014882|NCT01127321|BG001|Baseline|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
11014883|NCT01127321|BG002|Baseline|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
11014884|NCT01127321|BG003|Baseline|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
11014885|NCT01127321|BG004|Baseline|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
11014886|NCT01127321|BG005|Baseline|Total|Total of all reporting groups
11014887|NCT01127321|FG000|Participant Flow|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
11014888|NCT01127321|FG001|Participant Flow|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
11014889|NCT01127321|FG002|Participant Flow|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
11014890|NCT01127321|FG003|Participant Flow|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
11014891|NCT01127321|FG004|Participant Flow|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
11014892|NCT01127321|OG000|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
11014893|NCT01127321|OG001|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
11014894|NCT01127321|OG002|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
11014895|NCT01127321|OG003|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
11014896|NCT01127321|OG004|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
11014897|NCT01127321|EG000|Reported Event|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
11014898|NCT01127321|EG001|Reported Event|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
11014899|NCT01127321|EG002|Reported Event|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
11014900|NCT01127321|EG003|Reported Event|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
11014901|NCT01127321|EG004|Reported Event|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
11014902|NCT01127373|BG000|Baseline|Radiation Therapy Via Multi-beam IMRT|"This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.~Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.~BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment."
11014903|NCT01127373|FG000|Participant Flow|Radiation Therapy Via Multi-beam IMRT|"This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.~Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.~BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment."
11014904|NCT01127373|OG000|Outcome|Radiation Therapy Via Multi-beam IMRT|"This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.~Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.~BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment."
11014905|NCT01127373|EG000|Reported Event|Radiation Therapy Via Multi-beam IMRT|"This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.~Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.~BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment."
11014906|NCT01127438|BG000|Baseline|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
11014907|NCT01127438|BG001|Baseline|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
11014908|NCT01127438|BG002|Baseline|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
11014909|NCT01127438|BG003|Baseline|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
11014910|NCT01127438|BG004|Baseline|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
11014911|NCT01127438|BG005|Baseline|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
11014912|NCT01127438|BG006|Baseline|Total|Total of all reporting groups
11014913|NCT01127438|FG000|Participant Flow|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. The doses were weight-adjusted for each subject, with 6.5mg of Lusedra per kg during the Randomization Phase (1 day).
11014914|NCT01127438|FG001|Participant Flow|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomization Phase (1 day).
11014915|NCT01127438|FG002|Participant Flow|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
11014916|NCT01127438|FG003|Participant Flow|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomization Phase (1 day).
11014917|NCT01127438|FG004|Participant Flow|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 3.9mg of Lusedra per kg during the Randomization Phase (1 day).
11014918|NCT01127438|FG005|Participant Flow|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
11014919|NCT01127438|OG000|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
11014920|NCT01127438|OG001|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
11014921|NCT01127438|OG002|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
11014922|NCT01127438|OG003|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
11014923|NCT01127438|OG004|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
11014924|NCT01127438|OG005|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
11014925|NCT01127438|EG000|Reported Event|Lower Dose|Includes subgroups 1-3
11014926|NCT01127438|EG001|Reported Event|Approved Dose|Includes subgroups 1-3
11014927|NCT01127581|BG000|Baseline|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
11014928|NCT01127581|BG001|Baseline|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
11014929|NCT01127581|BG002|Baseline|Total|Total of all reporting groups
11014930|NCT01127581|FG000|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
11014931|NCT01127581|FG001|Participant Flow|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
11014932|NCT01127581|OG000|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
11014933|NCT01127581|OG001|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10886173|NCT00492557|OG001|Outcome|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
11014934|NCT01127581|EG000|Reported Event|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
11014935|NCT01127581|EG001|Reported Event|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
11014936|NCT01127607|BG000|Baseline|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
11014937|NCT01127607|BG001|Baseline|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
11014938|NCT01127607|BG002|Baseline|Total|Total of all reporting groups
11014939|NCT01127607|FG000|Participant Flow|Placebo Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period 1). The 14 subjects assigned to this arm were then switched to blinded placebo for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only placebo during period II.
11014940|NCT01127607|FG001|Participant Flow|Treatment Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period I). The 13 subjects assigned to this arm were then switched to blinded optimal dose of LDX for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only their optimal dose of LDX during period II.
11014941|NCT01127607|OG000|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
11014942|NCT01127607|OG001|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
11014943|NCT01127607|OG000|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
11014944|NCT01127607|OG001|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
11014945|NCT01127607|OG002|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
11014946|NCT01127607|OG003|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
11014947|NCT01127607|OG000|Outcome|Unmedicated|baseline; participants not on medication
11014948|NCT01127607|OG001|Outcome|Optimal Dose of Medication|Optimal dose of lisdexamfetamine (30 mg, 50 mg, or 70 mg) as selected by a three week open medication titration trial.
11014949|NCT01127607|OG000|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
11014950|NCT01127607|OG001|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
11014951|NCT01127607|OG000|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
11014952|NCT01127607|OG001|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
11014953|NCT01127607|OG000|Outcome|No Medication|The PSERS was completed at intake by all 38 participants who consented and met eligibility criteria in order to assess pre-medication rates of side effects. This was done because the PSERS measures commonly occurring events such as insomnia and irritability that can be seen in unmedicated patients with ADHD.
11014954|NCT01127607|OG001|Outcome|30 mg Lisdexamfetamine|This arm includes all participants who were prescribed the 30mg dose and completed at least one side effect rating for this dose.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study which is why this cell size is larger than for the randomized controlled comparison that followed it.
11014955|NCT01127607|OG002|Outcome|50 mg Lisdexamfetamine|This group includes all participants who were prescribed the 50mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg dose and are therefore included in that group as well.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study.
11014956|NCT01127607|OG003|Outcome|70 mg Lisdexamfetamine|This group includes all participants who were prescribed the 70mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg and 50mg doses and are therefore included in those groups as well. Not all participants who were prescribed this dose were optimized to this dose.
11014957|NCT01127607|EG000|Reported Event|Placebo Arm|subjects in this arm treated only with blinded placebo for duration of assessment (period II- between subjects trial).One participant assigned to placebo dropped out before medication was dispensed for period II which is why the side effect data only has a total of 13 and not 14 subjects.
11014958|NCT01127607|EG001|Reported Event|Treatment Arm|subjects in this arm (N=13) only treated with blinded optimal dose of LDX (either 30mg, 50mg or 70mg) for duration of assessment (period II between subjects trial).
11014959|NCT01127607|EG002|Reported Event|All Participants in Period 1 Prescribed 30mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~All 36 participants who were dispensed the 30mg dose and completed at least one Pittsburgh Side Effect Rating Scale (PSERS) are included in this category."
11014960|NCT01127607|EG003|Reported Event|All Participants in Period 1 Prescribed 50mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~21 of 36 participants were dispensed the 50mg dose."
11014961|NCT01127607|EG004|Reported Event|All Participants in Period 1 Prescribed 70mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~17 of 36 participants were dispensed the 70mg dose."
11014962|NCT01127633|BG000|Baseline|Placebo|Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
11014963|NCT01127633|BG001|Baseline|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
11014964|NCT01127633|BG002|Baseline|Total|Total of all reporting groups
11014965|NCT01127633|FG000|Participant Flow|Placebo|Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
11014966|NCT01127633|FG001|Participant Flow|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
11014967|NCT01127633|OG000|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
11014968|NCT01127633|OG001|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
11014969|NCT01127633|EG000|Reported Event|Placebo|Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
11014970|NCT01127633|EG001|Reported Event|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
11014971|NCT01127646|BG000|Baseline|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
11014972|NCT01127646|BG001|Baseline|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
11014973|NCT01127646|BG002|Baseline|Total|Total of all reporting groups
11014974|NCT01127646|FG000|Participant Flow|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
11014975|NCT01127646|FG001|Participant Flow|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
11014976|NCT01127646|OG000|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
11014977|NCT01127646|OG001|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
11014978|NCT01127646|OG000|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
11014979|NCT01127646|OG001|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
11014980|NCT01127646|EG000|Reported Event|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
11014981|NCT01127646|EG001|Reported Event|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
11014982|NCT01127659|BG000|Baseline|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks"
11014983|NCT01127659|BG001|Baseline|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
11014984|NCT01127659|BG002|Baseline|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
11014985|NCT01127659|BG003|Baseline|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
11014986|NCT01127659|BG004|Baseline|Eugonadal Diabetes|diabetic men with normal testosterone
11014987|NCT01127659|BG005|Baseline|Eugonadal Obese|obese non-diabetic men with normal testosterone
11014988|NCT01127659|BG006|Baseline|Total|Total of all reporting groups
11014989|NCT01127659|FG000|Participant Flow|Diabetes With HH: Testosterone|"active drug diabetes arm~testosterone: intramuscular every 2 weeks"
11014990|NCT01127659|FG001|Participant Flow|Diabetes With HH: Placebo|"placebo diabetes arm~placebo: saline intramuscular every 2 weeks"
10886174|NCT00492557|OG001|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
11014991|NCT01127659|FG002|Participant Flow|Obese Testosterone|"active drug obese arm~testosterone: intramuscular every 2 weeks"
11014992|NCT01127659|FG003|Participant Flow|Obese Placebo|"placebo obese arm~placebo: saline intramuscular every 2 weeks"
11014993|NCT01127659|FG004|Participant Flow|Eugonadal Diabetes|no intervention
11014994|NCT01127659|FG005|Participant Flow|Eugonadal Obese|no intervention
11014995|NCT01127659|OG000|Outcome|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks~Glucose infusion rate: 6.5+/-4.0 mg/kg fat-free mass/min"
11014996|NCT01127659|OG001|Outcome|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
11014997|NCT01127659|OG002|Outcome|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
11014998|NCT01127659|OG003|Outcome|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
11014999|NCT01127659|OG004|Outcome|Eugonadal Diabetes|"diabetic men with normal testosterone~Glucose infusion rate: 10.29+/-5.55 mg/kg fat-free mass/min"
11015000|NCT01127659|OG005|Outcome|Eugonadal Obese|obese non-diabetic men with normal testosterone
11015001|NCT01127659|EG000|Reported Event|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks"
11015002|NCT01127659|EG001|Reported Event|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
11015003|NCT01127659|EG002|Reported Event|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
11348876|NCT04140890|BG000|Baseline|Treatment|Participants in the treatment group will be asked to meet with an occupational therapist in their home weekly over 12 weeks. Each session takes an hour. In the first session, the occupational therapist will introduce the program. In session 2, the therapist will discuss pain and pain management with the participant. In session 3-12, the therapist will help the participant to develop physical activity and healthy eating habits. In each session the participant will pick two healthy behaviors to turn them into a habit. The therapist will give the participant a workbook and teach the participant to track his/her progress. The focus of session 3-5 will be physical activity, and session 6-11 will be healthy eating. In the last session (session 12), the therapist will wrap up the program and help the participant to develop a maintenance plan.
11348877|NCT04140890|BG001|Baseline|Control|Participants in the control group will receive newsletters focused on general healthy aging topics over 12 weeks. With the exception of two, 1-page handouts covering PA and dietary recommendations, the weekly content will not overlap with the treatment content. Within 4 days of mailing the newsletter, a trained research assistant (RA) will call the participant, verify receipt of the newsletter, and ask them if they have any questions about the materials. The phone call will last ~15 minutes. Control condition participants receive no further intervention.
11015004|NCT01127659|EG003|Reported Event|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
11015005|NCT01127659|EG004|Reported Event|Eugonadal Diabetes|diabetic men with normal testosterone
11015006|NCT01127659|EG005|Reported Event|Eugonadal Obese|obese non-diabetic men with normal testosterone
11015007|NCT01127737|BG000|Baseline|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
11015008|NCT01127737|BG001|Baseline|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
11015009|NCT01127737|BG002|Baseline|Total|Total of all reporting groups
11015010|NCT01127737|FG000|Participant Flow|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
11015011|NCT01127737|FG001|Participant Flow|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
11015012|NCT01127737|OG000|Outcome|Intervention|Educational intervention consisting of a mnemonic and a workboook
10886175|NCT00492557|EG000|Reported Event|13vPnC+TIV|Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM.
11015013|NCT01127737|OG001|Outcome|Placebo|
11015014|NCT01127737|EG000|Reported Event|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
11015015|NCT01127737|EG001|Reported Event|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
11015016|NCT01127763|BG000|Baseline|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
11015017|NCT01127763|FG000|Participant Flow|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
11015018|NCT01127763|OG000|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.~RAD001~Carboplatin"
11015019|NCT01127763|OG000|Outcome|RAD001+Carboplatin (AUC 6 and 5)|Carboplatin (starting dose of AUC 6 or AUC 5) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
11015020|NCT01127763|OG001|Outcome|RAD001+Carboplatin (AUC 4)|Carboplatin (starting dose of AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
11015021|NCT01127763|OG002|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
11015022|NCT01127763|OG000|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
11015023|NCT01127763|EG000|Reported Event|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
11015024|NCT01127893|BG000|Baseline|Tanezumab 2.5 mg|Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.
11015025|NCT01127893|FG000|Participant Flow|Tanezumab 2.5 mg|Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.
11015026|NCT01127893|OG000|Outcome|Tanezumab 2.5 mg|Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.
11015027|NCT01127893|EG000|Reported Event|Tanezumab 2.5 mg|Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.
11015028|NCT01128049|BG000|Baseline|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer's value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
11348878|NCT04140890|BG002|Baseline|Total|Total of all reporting groups
11015029|NCT01128049|BG001|Baseline|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
11015030|NCT01128049|BG002|Baseline|ADDE Population|Subjects with schirmer's value < 10mm/5 mins and no meibomian gland dysfunction.
11015031|NCT01128049|BG003|Baseline|Total|Total of all reporting groups
11015032|NCT01128049|FG000|Participant Flow|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer's value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
11015033|NCT01128049|FG001|Participant Flow|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
11015034|NCT01128049|FG002|Participant Flow|ADDE Population|Subjects with schirmer's value < 10mm/5 mins and no meibomian gland dysfunction.
11015035|NCT01128049|OG000|Outcome|Normal|Normal group included non-dry eye subjects.
11015036|NCT01128049|OG001|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects with mild to moderate Meibomian Gland Dysfunction (MGD) on a slit lamp examination were included in this group.
11015037|NCT01128049|OG002|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with a low tear volume measured by Schimer's score of less than 10 mm were included in this group.
11015038|NCT01128049|EG000|Reported Event|Normal Patient Population|Non-Dry Eye patient population (intervention remains the same across all arms)
11015039|NCT01128049|EG001|Reported Event|MGD Patient Population|Meibomium Gland Dysfunction population(intervention remains the same across all arms)
11015040|NCT01128049|EG002|Reported Event|ADDE Population|Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
11015041|NCT01128153|BG000|Baseline|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
11015042|NCT01128153|BG001|Baseline|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
11015043|NCT01128153|BG002|Baseline|Total|Total of all reporting groups
11015044|NCT01128153|FG000|Participant Flow|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
11015045|NCT01128153|FG001|Participant Flow|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
11015046|NCT01128153|OG000|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
11015047|NCT01128153|OG001|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
11015048|NCT01128153|EG000|Reported Event|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
11015049|NCT01128153|EG001|Reported Event|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
11015050|NCT01128179|BG000|Baseline|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
11015051|NCT01128179|BG001|Baseline|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
11015052|NCT01128179|BG002|Baseline|Total|Total of all reporting groups
11015053|NCT01128179|FG000|Participant Flow|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
11015054|NCT01128179|FG001|Participant Flow|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
11015055|NCT01128179|OG000|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
11015056|NCT01128179|OG001|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
11015057|NCT01128179|EG000|Reported Event|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
11015058|NCT01128179|EG001|Reported Event|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
11015059|NCT01128192|BG000|Baseline|Pasireotide 600 μg sc Bid|Pasireotide 600 μg sc bid n=19
11015060|NCT01128192|BG001|Baseline|Pasireotide 900 μg sc Bid|Pasireotide 900 μg sc bid n=19
11015061|NCT01128192|BG002|Baseline|Total|Total of all reporting groups
11015062|NCT01128192|FG000|Participant Flow|Pasireotide 600 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 600 μg (n=19). All participants completed the study.
11015063|NCT01128192|FG001|Participant Flow|Pasireotide 900 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 900 μg (n=19). All participants completed the study.
11015064|NCT01128192|FG002|Participant Flow|Pasireotide 1200 μg sc Bid|7 healthy male volunteers were randomized to receive Pasireotide 1200 μg (n=7). This arm was used in safety analysis only.
11015065|NCT01128192|OG000|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
11015066|NCT01128192|OG001|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
11015067|NCT01128192|OG000|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
11015068|NCT01128192|OG001|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
11015069|NCT01128192|OG000|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
11015070|NCT01128192|OG001|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
11015071|NCT01128192|EG000|Reported Event|Pasireotide 600 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
11015072|NCT01128192|EG001|Reported Event|Pasireotide 900 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
11015073|NCT01128192|EG002|Reported Event|Pasireotide 1200 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
11015074|NCT01128244|BG000|Baseline|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
11015075|NCT01128244|FG000|Participant Flow|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of the amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
11015076|NCT01128244|OG000|Outcome|Total Homocysteine Remethylation Flux|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
11015077|NCT01128244|OG000|Outcome|Homocysteine Remethylation Flux From Serine|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
11015078|NCT01128244|OG000|Outcome|Plasma Pyridoxal Phosphate Concentration|Plasma PLP will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
11015079|NCT01128244|OG000|Outcome|Plasma Cystathionine Concentration|Plasma cystathionine will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
11015080|NCT01128244|OG000|Outcome|Secondary Analysis: Plasma 3-hydroxykynurenine Concentration|Plasma 3-hydroxykynurenine concentration will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
11015081|NCT01128244|EG000|Reported Event|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of amino acids, serine, and methionine: Subjects will be given an infusion of the amino acids, serine, and methionine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
11015082|NCT01128270|BG000|Baseline|All Subjects|Intent was to have all subjects participate in all sessions (periods)
11015083|NCT01128270|FG000|Participant Flow|All Subjects|The intent was to have all subjects participate in all four sessions (periods). These were environmental chloral hydrate +/- environmental DCA and therapeutic chloral hydrate +/- therapeutic DCA. Patient participation: 4 Sessions (N=2), 3 Sessions (N=1), 2 Sessions (N=6), 1 Session (N=8), 0 Sessions (N=10), Total: N=27 patients participated in 31 sessions.
11015084|NCT01128270|OG000|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5. This outcome only applies to Period 3.
11015085|NCT01128270|OG000|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
11015086|NCT01128270|OG000|Outcome|Environmental Chloral Hydrate and DCA (1A)|Arm 1A: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights) and environmental Dichloroacetate on Day 1 (2.5 mcg/Kg.)pharmacokinetics are done on days 1 and 5.
11015087|NCT01128270|OG001|Outcome|Environmental Chloral Hydrate (1B)|Arm 1B: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights). Pharmacokinetics are done on days 1 and 5.
11015088|NCT01128270|OG002|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
11015089|NCT01128270|OG003|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
11015090|NCT01128270|EG000|Reported Event|1A: Chloral Hydrate+DCA (Environmental)|This is Period 1. See description of periods for full details.
11015091|NCT01128270|EG001|Reported Event|Chloral Hydrate (Environmental)|This is Period 2. See description of periods for full details.
11015092|NCT01128270|EG002|Reported Event|Chloral Hydrate +DCA (Therapeutic Dose)|This is Period 3. See description of periods for full details.
11015093|NCT01128270|EG003|Reported Event|Chloral Hydrate (Therapeutic Dose)|This is Period 4 See description of periods for full details.
11015094|NCT01128296|BG000|Baseline|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
11015095|NCT01128296|FG000|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
11015096|NCT01128296|FG001|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
11015097|NCT01128296|FG002|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
11015098|NCT01128296|FG003|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
11015099|NCT01128296|FG004|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
11015100|NCT01128296|FG005|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
11015101|NCT01128296|OG000|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
11015102|NCT01128296|OG001|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
11015103|NCT01128296|OG002|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
11015104|NCT01128296|OG003|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
11015105|NCT01128296|OG004|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
11015106|NCT01128296|OG005|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
11015107|NCT01128296|OG000|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants with pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (1200 mg/day) taken for 31 consecutive days until the day of surgery.
10886176|NCT00492557|EG001|Reported Event|Placebo|Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM [13vPnC + TIV]).
11015108|NCT01128296|OG000|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
11015109|NCT01128296|EG000|Reported Event|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
11066145|NCT01390844|EG000|Reported Event|Boceprevir - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
11015110|NCT01128361|BG000|Baseline|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
11015111|NCT01128361|BG001|Baseline|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
11015112|NCT01128361|BG002|Baseline|Total|Total of all reporting groups
11015113|NCT01128361|FG000|Participant Flow|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
11015114|NCT01128361|FG001|Participant Flow|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
11015115|NCT01128361|OG000|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
11015116|NCT01128361|OG001|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
11015117|NCT01128361|EG000|Reported Event|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
11015118|NCT01128361|EG001|Reported Event|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
11015119|NCT01128387|BG000|Baseline|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU"
11015120|NCT01128387|BG001|Baseline|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU"
11015121|NCT01128387|BG002|Baseline|Total|Total of all reporting groups
11015122|NCT01128387|FG000|Participant Flow|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)"
11015123|NCT01128387|FG001|Participant Flow|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU"
11015124|NCT01128387|OG000|Outcome|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU"
11015125|NCT01128387|OG001|Outcome|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU"
11015126|NCT01128387|EG000|Reported Event|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU"
11015127|NCT01128387|EG001|Reported Event|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU"
11015128|NCT01128400|BG000|Baseline|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
11015129|NCT01128400|BG001|Baseline|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
11015130|NCT01128400|BG002|Baseline|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
11015131|NCT01128400|BG003|Baseline|Total|Total of all reporting groups
11015132|NCT01128400|FG000|Participant Flow|rs1761667- AA Genotype|subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level and has a minor allele frequency of 38-48%.
11015133|NCT01128400|FG001|Participant Flow|rs1761667-GG Genotype|subjects who are homozygous of CD36 genotype rs1761667-G allele.
11015134|NCT01128400|FG002|Participant Flow|rs1761667-AG Genotype|Heterozygous of CD36 gene rs1761667-A genotype.
11015135|NCT01128400|OG000|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
11015136|NCT01128400|OG001|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
11015137|NCT01128400|OG002|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
11015138|NCT01128400|EG000|Reported Event|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
11015139|NCT01128400|EG001|Reported Event|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
11015140|NCT01128400|EG002|Reported Event|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
11015141|NCT01128413|BG000|Baseline|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
11015142|NCT01128413|BG001|Baseline|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
11015143|NCT01128413|BG002|Baseline|Total|Total of all reporting groups
11015144|NCT01128413|FG000|Participant Flow|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
11015145|NCT01128413|FG001|Participant Flow|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
11148303|NCT01862991|BG000|Baseline|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
11015146|NCT01128413|OG000|Outcome|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
11015147|NCT01128413|OG001|Outcome|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
11015148|NCT01128413|EG000|Reported Event|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
11015149|NCT01128413|EG001|Reported Event|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
11015150|NCT01128426|BG000|Baseline|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
11015151|NCT01128426|FG000|Participant Flow|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
11015152|NCT01128426|OG000|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
11015153|NCT01128426|OG000|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
11015154|NCT01128426|OG000|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
11015155|NCT01128426|EG000|Reported Event|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
11015156|NCT01128543|BG000|Baseline|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
11015157|NCT01128543|FG000|Participant Flow|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
11015158|NCT01128543|OG000|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
11015159|NCT01128543|EG000|Reported Event|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
11015160|NCT01128569|BG000|Baseline|Placebo, FF 100 µg OD, FF/VI 100/25 µg OD in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods once daily (OD) in the evening from the Dry Powder Inhaler (DPI) for 28 days: Placebo, Fluticasone Furoate (FF) 100 microgram (µg) dry inhalation powder, and FF/Vilanterol (FF/VI) 100/25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FF 100 µg, FF/VI 100/25 µg; (2) Placebo, FF/VI 100/25 µg, FF 100 µg; (3) FF 100 µg, FF/VI 100/25 µg, Placebo; (4) FF 100 µg, Placebo, FF/VI 100/25 µg; (5) FF/VI 100/25 µg, Placebo, FF 100 µg; (6) FF/VI 100/25 µg, FF 100 µg, Placebo. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11015161|NCT01128569|FG000|Participant Flow|Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received placebo, Fluticasone Furoate (FF) 100 micrograms (µg), and FF/Vilanterol (VI) 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11015162|NCT01128569|FG001|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11015163|NCT01128569|FG002|Participant Flow|Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11148304|NCT01862991|BG001|Baseline|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
11015164|NCT01128569|FG003|Participant Flow|Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg|Participants received FF 100 µg, placebo, and FF/VI 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11015165|NCT01128569|FG004|Participant Flow|Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg|Participants received FF/VI 100/25 µg, placebo, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11015166|NCT01128569|FG005|Participant Flow|Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo|Participants received FF/VI 100/25 µg, FF 100 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11015167|NCT01128569|OG000|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11015168|NCT01128569|OG001|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
11015169|NCT01128569|OG002|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
11015170|NCT01128569|EG000|Reported Event|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
11015171|NCT01128569|EG001|Reported Event|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
11015172|NCT01128569|EG002|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
11015173|NCT01128595|BG000|Baseline|Placebo, FF/VI 100/25 µg OD, FF 100 µg OD, VI 25 µg|All participants received one of the following four treatments in one of four treatment periods once daily (OD) from the Dry Powder Inhaler (DPI) for 21 days: Placebo; Fluticasone Furoate /Vilanterol (FF/VI) 100/25 microgram (µg) dry inhalation powder; Fluticasone Furoate (FF) 100 µg dry inhalation powder; and Vilanterol (VI) 25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the four following sequences: (1) VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg; (2) FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg; (3) Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg; (4) FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo. The four treatment periods were separated by a washout period of 21 to 35 days.
11015174|NCT01128595|FG000|Participant Flow|Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received Vilanterol (VI) 25 micrograms (µg), placebo, fluticasone furoate (FF) 100 µg, and FF/VI 100/25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
11015175|NCT01128595|FG001|Participant Flow|Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg|Participants received FF/VI 100/25 µg, FF 100 µg, placebo, and VI 25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
11015176|NCT01128595|FG002|Participant Flow|Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, VI 25 µg, and FF 100 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
11015177|NCT01128595|FG003|Participant Flow|Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, VI 25 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
11015178|NCT01128595|OG000|Outcome|Placebo|
11015179|NCT01128595|OG001|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
11015180|NCT01128595|OG002|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
11015181|NCT01128595|OG003|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
11015182|NCT01128595|OG000|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
11015183|NCT01128595|EG000|Reported Event|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
11015184|NCT01128595|EG001|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
11015185|NCT01128595|EG002|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
10886177|NCT00492557|EG002|Reported Event|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
11015186|NCT01128595|EG003|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
11015187|NCT01128621|BG000|Baseline|Part A: GSK1292263 300 mg|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
11015188|NCT01128621|BG001|Baseline|Part B: GSK1292263 75 mg/300 mg/ 600 mg|Participants received one of three dosing regimens of GSK1292263: 75 mg twice daily (BID) (as 1 x 75 mg tablet GSK1292263 + 2 placebo tablets in morning and evening), 300 mg BID (as 1 x 200 mg tablet + 1 x 75 mg tablet + 1 x 25 mg tablet GSK1292263 in morning and evening) and 600 mg once daily (QD) (as 3 x 200 mg tablets GSK1292263 in morning + 3 x placebo tablets in evening) or matching placebo BID (as 3 x placebo tablets in morning and evening), or open-label sitagliptin 50 mg BID for 14 days. Seven days before enrollment in Part B, participants taking metformin three times daily (TID) or using an extended-release formulation were converted to the equivalent total daily dose of immediate release metformin administered BID.
11015189|NCT01128621|BG002|Baseline|Total|Total of all reporting groups
11015190|NCT01128621|FG000|Participant Flow|Part A: GSK1292263 300 mg|Participants received a single dose of oral 300 milligrams (mg) tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
11015191|NCT01128621|FG001|Participant Flow|Part B: GSK1292263 75 mg/300 mg/ 600 mg|Participants received one of three dosing regimens of GSK1292263: 75 mg twice daily (BID) (as 1 x 75 mg tablet GSK1292263 + 2 placebo tablets in morning and evening), 300 mg BID (as 1 x 200 mg tablet + 1 x 75 mg tablet + 1 x 25 mg tablet GSK1292263 in morning and evening) and 600 mg once daily (QD) (as 3 x 200 mg tablets GSK1292263 in morning + 3 x placebo tablets in evening) or matching placebo BID (as 3 x placebo tablets in morning and evening), or open-label sitagliptin 50 mg BID for 14 days. Seven days before enrollment in Part B, participants taking metformin three times daily (TID) or using an extended-release formulation were converted to the equivalent total daily dose of immediate release metformin administered BID.
11015192|NCT01128621|OG000|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
11015193|NCT01128621|OG000|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days
11015194|NCT01128621|OG001|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days
11015195|NCT01128621|OG002|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days
11015196|NCT01128621|OG003|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
11015197|NCT01128621|OG004|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
11015198|NCT01128621|OG000|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
11015199|NCT01128621|OG001|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
11015200|NCT01128621|OG002|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
11015201|NCT01128621|OG004|Outcome|Sitagliptin 50mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
11015202|NCT01128621|OG000|Outcome|Arm A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
11015203|NCT01128621|OG000|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
11015204|NCT01128621|OG001|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
11015205|NCT01128621|OG002|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
11015206|NCT01128621|EG000|Reported Event|Part A - GSK1292263 300 mg|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
11015207|NCT01128621|EG001|Reported Event|Part B - Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
11015208|NCT01128621|EG002|Reported Event|Part B - GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
11015209|NCT01128621|EG003|Reported Event|Part B - GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
11015210|NCT01128621|EG004|Reported Event|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
11015211|NCT01128621|EG005|Reported Event|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
11148305|NCT01862991|BG002|Baseline|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
11148306|NCT01862991|BG003|Baseline|Total|Total of all reporting groups
11015212|NCT01128738|BG000|Baseline|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
11015213|NCT01128738|BG001|Baseline|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
11015214|NCT01128738|BG002|Baseline|Total|Total of all reporting groups
11015215|NCT01128738|FG000|Participant Flow|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
11015216|NCT01128738|FG001|Participant Flow|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
11015217|NCT01128738|OG000|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
11015218|NCT01128738|OG001|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
11015219|NCT01128738|OG002|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
11015220|NCT01128738|EG000|Reported Event|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
11015221|NCT01128738|EG001|Reported Event|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
11015222|NCT01128829|BG000|Baseline|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|"Obese subjects who do not use NNS and are insulin-sensitive (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6)."
11015223|NCT01128829|FG000|Participant Flow|"Water Then Sucralose"|"First intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load.~Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose 10 min before drinking a 75 g glucose load."
11148307|NCT01862991|FG000|Participant Flow|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
11015224|NCT01128829|FG001|Participant Flow|"Sucralose Then Water"|"First intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose10 min before drinking a 75 g glucose load.~Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load."
11015225|NCT01128829|OG000|Outcome|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|"Obese subjects who do not use NNS and are insulin-sensitive (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6)."
11015226|NCT01128829|EG000|Reported Event|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|"Obese subjects who do not use NNS and are insulin-sensitive (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6)."
11015227|NCT01128842|BG000|Baseline|Neratinib + Capecitabine|Neratinib: 240 mg, continuous once daily by mouth Capecitabine: 1500 mg/m^2 twice daily by mouth
11015228|NCT01128842|FG000|Participant Flow|Neratinib + Capecitabine|Neratinib: 240 mg once daily by mouth, Capecitabine: 1500 mg/m^2 twice daily.
11015229|NCT01128842|OG000|Outcome|Neratinib + Capecitabine|Neratinib: 240 mg once daily by mouth, Capecitabine: 1500 mg/m^2 twice daily by mouth.
11015230|NCT01128842|OG000|Outcome|Neratinib + Capecitabine|Neratinib: 240 mg once daily by mouth, Capecitabine: 1500 mg/m^2 twice daily by mouth
11015231|NCT01128842|EG000|Reported Event|Neratinib + Capecitabine|Neratinib: 240 mg once daily by mouth, Capecitabine: 1500 mg/m^2 twice daily by mouth.
11015232|NCT01128894|BG000|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
11015233|NCT01128894|BG001|Baseline|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
11015234|NCT01128894|BG002|Baseline|Total|Total of all reporting groups
11015235|NCT01128894|FG000|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
11015236|NCT01128894|FG001|Participant Flow|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
11015237|NCT01128894|OG000|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
11015238|NCT01128894|OG001|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
11015239|NCT01128894|EG000|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
11015240|NCT01128894|EG001|Reported Event|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
11015241|NCT01128946|BG000|Baseline|Overall|All randomized participants
11015242|NCT01128946|FG000|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015243|NCT01128946|FG001|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures
11015244|NCT01128946|FG002|Participant Flow|Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015245|NCT01128946|FG003|Participant Flow|NaF Toothpaste (675ppmF|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015246|NCT01128946|OG000|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015247|NCT01128946|OG001|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015248|NCT01128946|OG001|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015249|NCT01128946|OG002|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015250|NCT01128946|OG003|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015251|NCT01128946|EG000|Reported Event|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015252|NCT01128946|EG001|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015253|NCT01128946|EG002|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015254|NCT01128946|EG003|Reported Event|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11015255|NCT01128959|BG000|Baseline|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
11015256|NCT01128959|FG000|Participant Flow|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
11015257|NCT01128959|OG000|Outcome|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
11015258|NCT01128959|OG001|Outcome|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
11015259|NCT01128959|EG000|Reported Event|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|
11015260|NCT01128959|EG001|Reported Event|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|
11015261|NCT01128972|BG000|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
11015262|NCT01128972|FG000|Participant Flow|Test Dentifrice + Test Mouth Rinse (MR)|Participants were administered with treatment regimen comprising of test sodium fluoride (NaF) dentifrice [containing 1450 parts per million (ppm) fluoride (F) as NaF and potassium nitrate (KNO3)] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5 gram (g) test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
11015263|NCT01128972|FG001|Participant Flow|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015264|NCT01128972|FG002|Participant Flow|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference sodium monofluorophosphate (NaMFP)/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015265|NCT01128972|FG003|Participant Flow|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015266|NCT01128972|FG004|Participant Flow|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
11015267|NCT01128972|OG000|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
11015268|NCT01128972|OG001|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015269|NCT01128972|OG002|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015270|NCT01128972|OG003|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015271|NCT01128972|OG000|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
11015272|NCT01128972|OG001|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
11015273|NCT01128972|OG002|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015274|NCT01128972|OG003|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015275|NCT01128972|OG004|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015276|NCT01128972|OG000|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11148308|NCT01862991|FG001|Participant Flow|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
11015277|NCT01128972|OG001|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015278|NCT01128972|EG000|Reported Event|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
11015279|NCT01128972|EG001|Reported Event|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015280|NCT01128972|EG002|Reported Event|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015281|NCT01128972|EG003|Reported Event|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
11015282|NCT01128972|EG004|Reported Event|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
11015283|NCT01129024|BG000|Baseline|Lusutrombopag|Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
11015284|NCT01129024|FG000|Participant Flow|Lusutrombopag|Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
11015285|NCT01129024|OG000|Outcome|Lusutrombopag|Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
11015286|NCT01129024|EG000|Reported Event|Lusutrombopag|Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
11015287|NCT01129102|BG000|Baseline|NPC-01|Norethisterone 1mg, Ethinyl estradiol 0.02mg
11015288|NCT01129102|BG001|Baseline|IKH-01|Norethisterone 1mg, Ethinyl estradiol 0.035mg
11015289|NCT01129102|BG002|Baseline|Placebo|Placebo for NPC-01
11015290|NCT01129102|BG003|Baseline|Total|Total of all reporting groups
11015291|NCT01129102|FG000|Participant Flow|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
11015292|NCT01129102|FG001|Participant Flow|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg~IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
11015293|NCT01129102|FG002|Participant Flow|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
11015294|NCT01129102|OG000|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
11015295|NCT01129102|OG001|Outcome|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
11015296|NCT01129102|EG000|Reported Event|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
11015297|NCT01129102|EG001|Reported Event|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg~IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
11015298|NCT01129102|EG002|Reported Event|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
11015299|NCT01129115|BG000|Baseline|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
11015300|NCT01129115|BG001|Baseline|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
11015301|NCT01129115|BG002|Baseline|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
11015302|NCT01129115|BG003|Baseline|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
11015303|NCT01129115|BG004|Baseline|Total|Total of all reporting groups
11015304|NCT01129115|FG000|Participant Flow|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
11015305|NCT01129115|FG001|Participant Flow|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
11015306|NCT01129115|FG002|Participant Flow|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
11015307|NCT01129115|FG003|Participant Flow|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
11015308|NCT01129115|OG000|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
11015309|NCT01129115|OG001|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
11015310|NCT01129115|OG002|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
11015311|NCT01129115|OG003|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
11015312|NCT01129115|EG000|Reported Event|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
11015313|NCT01129115|EG001|Reported Event|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
11015314|NCT01129115|EG002|Reported Event|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
11015315|NCT01129115|EG003|Reported Event|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
11015316|NCT01129128|BG000|Baseline|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
11015317|NCT01129128|BG001|Baseline|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
11015318|NCT01129128|BG002|Baseline|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
11015319|NCT01129128|BG003|Baseline|Total|Total of all reporting groups
11015320|NCT01129128|FG000|Participant Flow|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
11015321|NCT01129128|FG001|Participant Flow|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
11015322|NCT01129128|FG002|Participant Flow|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
11015323|NCT01129128|OG000|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
11015324|NCT01129128|OG001|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
11015325|NCT01129128|OG002|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
11015326|NCT01129128|EG000|Reported Event|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
11015327|NCT01129128|EG001|Reported Event|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
11015328|NCT01129128|EG002|Reported Event|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
11015329|NCT01129141|BG000|Baseline|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
11015330|NCT01129141|BG001|Baseline|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
11015331|NCT01129141|BG002|Baseline|Total|Total of all reporting groups
11015332|NCT01129141|FG000|Participant Flow|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
11015333|NCT01129141|FG001|Participant Flow|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
11015334|NCT01129141|OG000|Outcome|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
11015335|NCT01129141|OG001|Outcome|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
11015336|NCT01129141|EG000|Reported Event|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
11015337|NCT01129141|EG001|Reported Event|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
11015338|NCT01129206|BG000|Baseline|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
11015339|NCT01129206|FG000|Participant Flow|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
11015340|NCT01129206|OG000|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
11015341|NCT01129206|OG000|Outcome|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
11015342|NCT01129206|OG000|Outcome|PERCIST Criteria Per PET|
11015343|NCT01129206|OG001|Outcome|RECIST Criteria Per CT|
11015344|NCT01129206|EG000|Reported Event|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
11148309|NCT01862991|FG002|Participant Flow|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
11015345|NCT01129245|BG000|Baseline|PreLH/postLH|Control cycle First, preLH surge dosing of celecoxib and postLH surge dosing of placebo. Followed by, preLH surge dosing of placebo and postLH surge dosing of drug.
11015346|NCT01129245|BG001|Baseline|PostLH/preLH|Control cycle First, postLH surge dosing of celecoxib and preLH surge dosing of placebo. Followed by, postLH surge dosing of placebo and preLH surge dosing of drug.
11015347|NCT01129245|BG002|Baseline|Total|Total of all reporting groups
11015348|NCT01129245|FG000|Participant Flow|PreLH Followed by postLH|Control cycle First, preLH surge dosing of celecoxib and postLH surge dosing of placebo. Followed by, preLH surge dosing of placebo and postLH surge dosing of drug.
11015349|NCT01129245|FG001|Participant Flow|PostLH Followed by preLH|Control cycle First, postLH surge dosing of celecoxib and preLH surge dosing of placebo. Followed by, postLH surge dosing of placebo and preLH surge dosing of drug.
11015350|NCT01129245|OG000|Outcome|Control Cycle|Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.
11015351|NCT01129245|OG001|Outcome|Pre-LH Celecoxib|"Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results~Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
11015352|NCT01129245|OG002|Outcome|Post-LH Surge Celecoxib|"Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.~Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
11015353|NCT01129245|OG001|Outcome|Pre-LH Celecoxib|Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
11015354|NCT01129245|EG000|Reported Event|Control Cycle|Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.
11015355|NCT01129245|EG001|Reported Event|Pre-LH Celecoxib|"Received Celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.~Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings."
11015356|NCT01129245|EG002|Reported Event|Post-LH Surge Celecoxib|"Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.~Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
11015357|NCT01129284|BG000|Baseline|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy
11015358|NCT01129284|BG001|Baseline|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)
11015359|NCT01129284|BG002|Baseline|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease)
11015360|NCT01129284|BG003|Baseline|Total|Total of all reporting groups
11015361|NCT01129284|FG000|Participant Flow|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
11015362|NCT01129284|FG001|Participant Flow|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
11015363|NCT01129284|FG002|Participant Flow|Immunoglobulin A (IgA) Nephropathy|Subjects diagnosed with Immunoglobulin A (IgA) nephropathy (Berger's disease) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
11015364|NCT01129284|OG000|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
11015365|NCT01129284|OG001|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
11015366|NCT01129284|OG002|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
11015367|NCT01129284|EG000|Reported Event|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
11015368|NCT01129284|EG001|Reported Event|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
11015369|NCT01129284|EG002|Reported Event|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
11015370|NCT01129336|BG000|Baseline|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
11015371|NCT01129336|BG001|Baseline|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
11015372|NCT01129336|BG002|Baseline|Total|Total of all reporting groups
11015373|NCT01129336|FG000|Participant Flow|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
11015374|NCT01129336|FG001|Participant Flow|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
11015375|NCT01129336|OG000|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
11015376|NCT01129336|OG001|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
11015377|NCT01129336|EG000|Reported Event|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
11015378|NCT01129336|EG001|Reported Event|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
11015379|NCT01129440|BG000|Baseline|Fluoride Varnish|"Topical fluoride varnish (FV) applications every 6 months~Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months."
11015380|NCT01129440|BG001|Baseline|FV + Glass Ionomer Sealants|"Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed~Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.~Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.~After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar."
11015381|NCT01129440|BG002|Baseline|Total|Total of all reporting groups
11015382|NCT01129440|FG000|Participant Flow|Fluoride Varnish|"Topical fluoride varnish (FV) applications every 6 months~Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months."
11015383|NCT01129440|FG001|Participant Flow|FV + Glass Ionomer Sealants|"Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed~Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.~Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.~After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar."
11015384|NCT01129440|OG000|Outcome|Fluoride Varnish|"Topical fluoride varnish (FV) applications every 6 months~Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months."
11015385|NCT01129440|OG001|Outcome|FV + Glass Ionomer Sealants|"Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed~Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.~Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.~After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar."
11015386|NCT01129440|OG000|Outcome|FV + Glass Ionomer Sealants|"Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.~Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.~After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar."
11015387|NCT01129440|EG000|Reported Event|Fluoride Varnish|"Topical fluoride varnish (FV) applications every 6 months~Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months."
11015388|NCT01129440|EG001|Reported Event|FV + Glass Ionomer Sealants|"Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed~Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.~Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.~After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar."
11015389|NCT01129531|BG000|Baseline|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
11015390|NCT01129531|BG001|Baseline|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
11015391|NCT01129531|BG002|Baseline|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
11015392|NCT01129531|BG003|Baseline|Total|Total of all reporting groups
11015393|NCT01129531|FG000|Participant Flow|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
11015394|NCT01129531|FG001|Participant Flow|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
11015395|NCT01129531|FG002|Participant Flow|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
11015396|NCT01129531|OG000|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
11015397|NCT01129531|OG001|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
11015398|NCT01129531|OG002|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
11015399|NCT01129531|OG002|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. Participants received two treatments 12 weeks apart.
11015400|NCT01129531|EG000|Reported Event|AGN-214868 3.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
11015401|NCT01129531|EG001|Reported Event|AGN-214868 16.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
11015402|NCT01129531|EG002|Reported Event|Placebo_Cycle 1|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
11015403|NCT01129531|EG003|Reported Event|AGN-214868 3.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
11015404|NCT01129531|EG004|Reported Event|AGN-214868 16.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
11015405|NCT01129531|EG005|Reported Event|Placebo_Cycle 2|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
11015406|NCT01129557|BG000|Baseline|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
11015407|NCT01129557|BG001|Baseline|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
11015408|NCT01129557|BG002|Baseline|Tekturna+Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
11015409|NCT01129557|BG003|Baseline|Total|Total of all reporting groups
11015410|NCT01129557|FG000|Participant Flow|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
11015411|NCT01129557|FG001|Participant Flow|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
11015412|NCT01129557|FG002|Participant Flow|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
11015413|NCT01129557|OG000|Outcome|Diovan|valsartan [angiotensin receptor blocker (ARB)] : Diovan 320 mg PO once daily for 9 months
11015414|NCT01129557|OG001|Outcome|Tekturna|aliskiren [direct renin inhibitor (DRI)] : Tekturna 300 mg PO once daily for 9 months
11015415|NCT01129557|OG002|Outcome|Tekturna + Diovan|aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
11015416|NCT01129557|OG000|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
11015417|NCT01129557|OG001|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
11015418|NCT01129557|OG002|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
11015419|NCT01129557|OG003|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
11015420|NCT01129557|OG004|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
11015421|NCT01129557|OG005|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
11015422|NCT01129557|OG006|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
11015423|NCT01129557|OG007|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
11015424|NCT01129557|OG001|Outcome|Final: Subjects Without Aldosterone Breakthrough|
11015425|NCT01129557|OG002|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
11015426|NCT01129557|OG003|Outcome|Final: Subjects With Aldosterone Breakthrough|
11015427|NCT01129557|EG000|Reported Event|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
11015428|NCT01129557|EG001|Reported Event|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
11015429|NCT01129557|EG002|Reported Event|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
11015430|NCT01129583|BG000|Baseline|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
11015431|NCT01129583|BG001|Baseline|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
11015432|NCT01129583|BG002|Baseline|Total|Total of all reporting groups
11015433|NCT01129583|FG000|Participant Flow|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
11015434|NCT01129583|FG001|Participant Flow|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
11015435|NCT01129583|OG000|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
11015436|NCT01129583|OG001|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
11015437|NCT01129583|EG000|Reported Event|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
11015438|NCT01129583|EG001|Reported Event|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
11015439|NCT01129609|BG000|Baseline|All Enrolled Subjects|Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System: All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft
11015440|NCT01129609|FG000|Participant Flow|All Enrolled Subjects|Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System: All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft
11015441|NCT01129609|OG000|Outcome|All Enrolled Subjects|Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System: All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft
11015442|NCT01129609|EG000|Reported Event|All Enrolled Subjects|Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System: All Subjects enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft.
11015443|NCT01129622|BG000|Baseline|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
11015444|NCT01129622|FG000|Participant Flow|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
11015445|NCT01129622|OG000|Outcome|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
11015446|NCT01129622|OG000|Outcome|Adverse Events|Hypo-estrogenic side effects
11015447|NCT01129622|EG000|Reported Event|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
11066146|NCT01390844|EG001|Reported Event|Control - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
11066147|NCT01390844|EG002|Reported Event|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
11066148|NCT01390844|EG003|Reported Event|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
11066149|NCT01390857|BG000|Baseline|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
11015448|NCT01129765|BG000|Baseline|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
11015449|NCT01129765|FG000|Participant Flow|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
11015450|NCT01129765|OG000|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
11015451|NCT01129765|EG000|Reported Event|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
11015452|NCT01129778|BG000|Baseline|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
11015453|NCT01129778|FG000|Participant Flow|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
11015454|NCT01129778|OG000|Outcome|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
11015455|NCT01129778|EG000|Reported Event|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
11015456|NCT01129804|BG000|Baseline|Network Support|"Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.~Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking."
11015457|NCT01129804|BG001|Baseline|Packaged Cognitive-Behavioral Treatment|"The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.~Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking."
11015458|NCT01129804|BG002|Baseline|Total|Total of all reporting groups
11015459|NCT01129804|FG000|Participant Flow|Network Support|"Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.~Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking."
11015460|NCT01129804|FG001|Participant Flow|Packaged Cognitive-Behavioral Treatment|"The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.~Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking."
11015461|NCT01129804|OG000|Outcome|Network Support|"Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.~Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking."
11015462|NCT01129804|OG001|Outcome|Packaged Cognitive-Behavioral Treatment|"The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.~Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking."
11015463|NCT01129804|EG000|Reported Event|Network Support|"Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.~Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking."
11015464|NCT01129804|EG001|Reported Event|Packaged Cognitive-Behavioral Treatment|"The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.~Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking."
11015465|NCT01129882|BG000|Baseline|Aripiprazole IM Depot|Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
11015466|NCT01129882|FG000|Participant Flow|Aripiprazole IM Depot|Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
11015467|NCT01129882|OG000|Outcome|Aripiprazole IM Depot|Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
11015468|NCT01129882|EG000|Reported Event|Aripiprazole IM Depot|Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
11015469|NCT01129921|BG000|Baseline|Mild Procedure|Group 1: mild percutaneous decompression with removal of bone and tissue
11015470|NCT01129921|BG001|Baseline|Sham Procedure|Group 2: sham decompression with trocar placement and no bone or tissue removal
11015471|NCT01129921|BG002|Baseline|Total|Total of all reporting groups
11015472|NCT01129921|FG000|Participant Flow|Percutaneous Decompression Procedure Only|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
11015473|NCT01129921|FG001|Participant Flow|Sham Then Percutaneous Decompression With Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
11015474|NCT01129921|OG000|Outcome|Mild Procedure Group 1|Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.
11015475|NCT01129921|OG001|Outcome|Sham Procedure Group 2 Prior to Cross-over|Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
11015476|NCT01129921|OG000|Outcome|Mild Group 1 Year-1 Cohort|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
11015477|NCT01129921|OG001|Outcome|Sham Group 2 Year-1 Cohort After X-over to Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
11015478|NCT01129921|OG000|Outcome|Percutaneous Decompression Procedure Only|Mild Group 1 Year-1 Cohort: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
11015479|NCT01129921|OG001|Outcome|Sham Then Percutaneous Decompression With Mild|Sham Group 2 Year-1 Cohort: After cross-over to the active mild procedure study arm in which bone and tissue were removed using the mild device kit.
11015480|NCT01129921|EG000|Reported Event|Mild Procedure|percutaneous decompression with bone and tissue removal
11015481|NCT01129921|EG001|Reported Event|Sham Procedure With Optional Crossover to Mild Post-unblinding|Sham procedure includes percutaneous trocar placement with no tissue or bone removal.
11015482|NCT01129960|BG000|Baseline|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
11015483|NCT01129960|BG001|Baseline|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
11015484|NCT01129960|BG002|Baseline|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
11015485|NCT01129960|BG003|Baseline|Placebo|Placebo: Tablets will be used.
11015486|NCT01129960|BG004|Baseline|Total|Total of all reporting groups
11015487|NCT01129960|FG000|Participant Flow|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
11015488|NCT01129960|FG001|Participant Flow|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
11015489|NCT01129960|FG002|Participant Flow|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
11015490|NCT01129960|FG003|Participant Flow|Placebo|Placebo: Tablets will be used.
11015491|NCT01129960|OG000|Outcome|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
11015492|NCT01129960|OG001|Outcome|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
11015493|NCT01129960|OG002|Outcome|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
11015494|NCT01129960|OG003|Outcome|Placebo|Placebo: Tablets will be used.
11015495|NCT01129960|EG000|Reported Event|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
11015496|NCT01129960|EG001|Reported Event|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
10886178|NCT00492557|EG003|Reported Event|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM [Placebo + TIV]).
10886179|NCT00492583|BG000|Baseline|Placebo|
10886180|NCT00492583|BG001|Baseline|Bifidobacterium Lactis (BB-12)|
10886181|NCT00492583|BG002|Baseline|Total|Total of all reporting groups
10886182|NCT00492583|FG000|Participant Flow|Placebo|
11015497|NCT01129960|EG002|Reported Event|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
11015498|NCT01129960|EG003|Reported Event|Placebo|Placebo: Tablets will be used.
11015499|NCT01130051|BG000|Baseline|Colcrys® Intact Tab and Colcrys® in Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
11015500|NCT01130051|FG000|Participant Flow|Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours
11015501|NCT01130051|FG001|Participant Flow|Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours
11015502|NCT01130051|OG000|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
11015503|NCT01130051|OG001|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
11015504|NCT01130051|EG000|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
11015505|NCT01130051|EG001|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
11148310|NCT01862991|OG000|Outcome|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
11148311|NCT01862991|OG001|Outcome|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
11148312|NCT01862991|OG002|Outcome|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
11148313|NCT01862991|EG000|Reported Event|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
11148314|NCT01862991|EG001|Reported Event|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
11148315|NCT01862991|EG002|Reported Event|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
11148316|NCT01863017|BG000|Baseline|Sham tDCS|"Five consecutive sessions of no tDCS. Each session will last approximately 30 minutes. Current will be applied for 20 minutes. Less than 3 minutes of tDCS has been shown to induce no lasting effects. Normal weight control participants will receive one sham session and one active session.~tDCS"
11148317|NCT01863017|BG001|Baseline|Active tDCS|"Five consecutive sessions of tDCS administered. Each session will take about 30 minutes. Normal weight control participants will receive one sham session and one active session.~tDCS"
11148318|NCT01863017|BG002|Baseline|Total|Total of all reporting groups
11148319|NCT01863017|FG000|Participant Flow|Sham tDCS|"Five consecutive sessions of no transcranial direct current stimulation (tDCS). Each session will last approximately 30 minutes. Current will be applied for 20 minutes. Less than 3 minutes of tDCS has been shown to induce no lasting effects. Normal weight control participants will receive one sham session and one active session.~tDCS"
11148320|NCT01863017|FG001|Participant Flow|Active tDCS|"Five consecutive sessions of tDCS administered. Each session will take about 30 minutes. Normal weight control participants will receive one sham session and one active session.~tDCS"
11148321|NCT01863017|OG000|Outcome|Sham tDCS|"Five consecutive sessions of no tDCS. Each session will last approximately 30 minutes. Current will be applied for 20 minutes. Less than 3 minutes of tDCS has been shown to induce no lasting effects. Normal weight control participants will receive one sham session and one active session.~tDCS"
11148322|NCT01863017|OG001|Outcome|Active tDCS|"Five consecutive sessions of tDCS administered. Each session will take about 30 minutes. Normal weight control participants will receive one sham session and one active session.~tDCS"
11148323|NCT01863017|EG000|Reported Event|Sham tDCS|Brief Stimulation
11148324|NCT01863017|EG001|Reported Event|Active tDCS|Transcranial Direct Current Stimulation for 30 minutes
11148325|NCT01863030|BG000|Baseline|Phasix Mesh|"Mesh being used for approved use. Mesh for ventral and incisional hernias.~Phasix mesh implant"
11148326|NCT01863030|FG000|Participant Flow|Phasix Mesh|Phasix mesh implant
11148327|NCT01863030|OG000|Outcome|Phasix Mesh|"Mesh being used for approved use. Mesh for ventral and incisional hernias.~Phasix mesh implant"
11148328|NCT01863030|OG000|Outcome|Phasix Mesh|Phasix mesh implant
11148329|NCT01863030|EG000|Reported Event|Phasix Mesh|"Mesh being used for approved use. Mesh for ventral and incisional hernias.~Phasix mesh implant"
11148330|NCT01863134|BG000|Baseline|Placebo/Control Group|In the control group patients were given identical doses of acetylsalicylic acid and enoxaparin followed by a placebo infusion of saline in lieu of the GPIIb/IIIa inhibitor.
11148331|NCT01863134|BG001|Baseline|Eptifibatide|In the treatment group patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery). The minimal and maximal periods of eptifibatide infusion were established at 12 and 48 hours respectively.
11148332|NCT01863134|BG002|Baseline|Total|Total of all reporting groups
11148333|NCT01863134|FG000|Participant Flow|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
11148334|NCT01863134|FG001|Participant Flow|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
11148335|NCT01863134|OG000|Outcome|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
11148336|NCT01863134|OG001|Outcome|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
11148337|NCT01863134|EG000|Reported Event|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
11148338|NCT01863134|EG001|Reported Event|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
11148339|NCT01863368|BG000|Baseline|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
11148340|NCT01863368|BG001|Baseline|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
10886183|NCT00492583|FG001|Participant Flow|Bifidobacterium Lactis (BB-12)|
10886184|NCT00492583|OG000|Outcome|Placebo|
11148341|NCT01863368|BG002|Baseline|Total|Total of all reporting groups
11148342|NCT01863368|FG000|Participant Flow|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
11148343|NCT01863368|FG001|Participant Flow|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
11148344|NCT01863368|OG000|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
11148345|NCT01863368|OG001|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
11148346|NCT01863368|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
11148347|NCT01863368|EG001|Reported Event|Systane Ultra|All subjects who were exposed to Systane Ultra or run-in therapy
11148348|NCT01863368|EG002|Reported Event|Optive|All subjects who were exposed to Optive or run-in therapy
11148349|NCT01863433|BG000|Baseline|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
11148350|NCT01863433|FG000|Participant Flow|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
11148351|NCT01863433|OG000|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
11148352|NCT01863433|EG000|Reported Event|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
11148353|NCT01863498|BG000|Baseline|PCA Pain Control|"Patients will have PCA for pain control~PCA: Patients will have PCA for pain control"
11148354|NCT01863498|BG001|Baseline|Epidural Pain Control|"Patients will have an epidural for pain control~Epidural: Patients will have an epidural for pain control"
11148355|NCT01863498|BG002|Baseline|Total|Total of all reporting groups
11148356|NCT01863498|FG000|Participant Flow|PCA Pain Control|"Patients will have PCA for pain control~PCA: Patients will have PCA for pain control"
11148357|NCT01863498|FG001|Participant Flow|Epidural Pain Control|"Patients will have an epidural for pain control~Epidural: Patients will have an epidural for pain control"
11148358|NCT01863498|OG000|Outcome|PCA Pain Control|"Patients will have PCA for pain control~PCA: Patients will have PCA for pain control"
11148359|NCT01863498|OG001|Outcome|Epidural Pain Control|"Patients will have an epidural for pain control~Epidural: Patients will have an epidural for pain control"
11148360|NCT01863498|EG000|Reported Event|PCA Pain Control|"Patients will have PCA for pain control~PCA: Patients will have PCA for pain control"
11148361|NCT01863498|EG001|Reported Event|Epidural Pain Control|"Patients will have an epidural for pain control~Epidural: Patients will have an epidural for pain control"
11148362|NCT01863563|BG000|Baseline|Quickclot|QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy
11148363|NCT01863563|FG000|Participant Flow|QuickClot|single dose
11148364|NCT01863563|OG000|Outcome|Cauterization Time|single dose
11148365|NCT01863563|EG000|Reported Event|Adverse Events|defined as bleeding or dehydration requiring medical intervention
11015506|NCT01130103|BG000|Baseline|Paroxetine|Paroxetine and Prolonged Exposure Therapy
11015507|NCT01130103|BG001|Baseline|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
11015508|NCT01130103|BG002|Baseline|Total|Total of all reporting groups
11015509|NCT01130103|FG000|Participant Flow|Paroxetine|Paroxetine and Prolonged Exposure Therapy
11015510|NCT01130103|FG001|Participant Flow|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
11015511|NCT01130103|OG000|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
11015512|NCT01130103|OG001|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
11015513|NCT01130103|EG000|Reported Event|Paroxetine|Paroxetine and Prolonged Exposure Therapy
11015514|NCT01130103|EG001|Reported Event|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
11015515|NCT01130168|BG000|Baseline|All Participants|
11015516|NCT01130168|FG000|Participant Flow|Placebo/ISMN ER/Amlodipine (Sequence 1)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. Experimental: ISMN ER/Amlodipine/Placebo
11015517|NCT01130168|FG001|Participant Flow|ISMN ER/Amlodipine/Placebo (Sequence 2)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
11015518|NCT01130168|FG002|Participant Flow|Amlodipine/Placebo/ISMN ER (Sequence 3)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
11015519|NCT01130168|FG003|Participant Flow|ISMN ER/Placebo/Amlodipine (Sequence 4)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.
11015520|NCT01130168|FG004|Participant Flow|Placebo/Amlodipine/ISMN ER (Sequence 5)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.
11015521|NCT01130168|FG005|Participant Flow|Amlodipine/ISMN ER/Placebo (Sequence 6)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.
10886185|NCT00492583|OG001|Outcome|Bifidobacterium Lactis (BB-12)|
10886186|NCT00492583|EG000|Reported Event|Placebo|
10886187|NCT00492583|EG001|Reported Event|Bifidobacterium Lactis (BB-12)|
10886188|NCT00492622|BG000|Baseline|All Participants|
10886189|NCT00492622|FG000|Participant Flow|All Study Participants|All participants were randomized to receive all formulations so baseline measures are reported for all participants.
10886190|NCT00492622|OG000|Outcome|All Study Participants Immediate Release Arm|Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
10886191|NCT00492622|OG001|Outcome|All Study Subjects Delayed Release Arm|Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
10886192|NCT00492622|OG000|Outcome|All Study Participants Immediate Release Arm|Immediate-release omeprazole concentration: Immediate-release omeprazole 40 mg qam for 7 days
10886193|NCT00492622|OG001|Outcome|All Study Subjects Delayed Release Arm|Delayed-release omeprazole concentration: Delayed-release omeprazole 40 mg qam for 7 days
10886194|NCT00492622|EG000|Reported Event|Immediate Release Fomeprazole|"subjects received immediate release for 7 days then delayed release for 7 days~Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days"
10886195|NCT00492622|EG001|Reported Event|Delayed Release Omeprazole|"subjects receive delayed release for 7 days then immediate release for 7 days~Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days"
10886196|NCT00492648|BG000|Baseline|GSK1437173A 18-30 Years Old Group|Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.
10886197|NCT00492648|BG001|Baseline|GSK1437173A 50-70 Years Old Group|Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
10886198|NCT00492648|BG002|Baseline|Total|Total of all reporting groups
10886199|NCT00492648|FG000|Participant Flow|GSK1437173A 18-30 Years Old Group|Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.
10886200|NCT00492648|FG001|Participant Flow|GSK1437173A 50-70 Years Old Group|Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
10886201|NCT00492648|OG000|Outcome|GSK1437173A 18-30 Years Old Group|Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.
10886202|NCT00492648|OG001|Outcome|GSK1437173A 50-70 Years Old Group|Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
10886203|NCT00492648|EG000|Reported Event|GSK1437173A 18-30 Years Old Group|Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine.
10886204|NCT00492648|EG001|Reported Event|GSK1437173A 50-70 Years Old Group|Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine.
10886205|NCT00492726|BG000|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
11015522|NCT01130168|OG000|Outcome|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
11015523|NCT01130168|OG001|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
11015524|NCT01130168|OG002|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
11015525|NCT01130168|OG000|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
11015526|NCT01130168|EG000|Reported Event|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
10886206|NCT00492726|BG001|Baseline|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
10886207|NCT00492726|BG002|Baseline|Total|Total of all reporting groups
10886208|NCT00492726|FG000|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
10886209|NCT00492726|FG001|Participant Flow|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
10886210|NCT00492726|OG000|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
10886211|NCT00492726|OG001|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
11015527|NCT01130168|EG001|Reported Event|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
11015528|NCT01130168|EG002|Reported Event|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
11015529|NCT01130272|BG000|Baseline|Eluxadoline 5 mg|Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
11015530|NCT01130272|BG001|Baseline|Eluxadoline 25 mg|Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks.
11015531|NCT01130272|BG002|Baseline|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
11015532|NCT01130272|BG003|Baseline|Eluxadoline 200 mg|Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
11015533|NCT01130272|BG004|Baseline|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
11015534|NCT01130272|BG005|Baseline|Total|Total of all reporting groups
11015535|NCT01130272|FG000|Participant Flow|Eluxadoline 5 mg|Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
11015536|NCT01130272|FG001|Participant Flow|Eluxadoline 25 mg|Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks.
11015537|NCT01130272|FG002|Participant Flow|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
11015538|NCT01130272|FG003|Participant Flow|Eluxadoline 200 mg|Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
11015539|NCT01130272|FG004|Participant Flow|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
11015540|NCT01130272|OG000|Outcome|Eluxadoline 5 mg|Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
11015541|NCT01130272|OG001|Outcome|Eluxadoline 25 mg|Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks.
11015542|NCT01130272|OG002|Outcome|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
11225649|NCT02369848|OG000|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
11015543|NCT01130272|OG003|Outcome|Eluxadoline 200 mg|Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
11015544|NCT01130272|OG004|Outcome|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
11015545|NCT01130272|EG000|Reported Event|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
11015546|NCT01130272|EG001|Reported Event|Eluxadoline 5 mg|Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
11015547|NCT01130272|EG002|Reported Event|Eluxadoline 25 mg|Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks.
11015548|NCT01130272|EG003|Reported Event|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
11015549|NCT01130272|EG004|Reported Event|Eluxadoline 200 mg|Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
11015550|NCT01130337|BG000|Baseline|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
11015551|NCT01130337|FG000|Participant Flow|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
11015552|NCT01130337|OG000|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
11066150|NCT01390857|FG000|Participant Flow|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
11066151|NCT01390857|OG000|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
11015553|NCT01130337|EG000|Reported Event|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
11015554|NCT01130493|BG000|Baseline|All Study Participants|Participants who were randomized to receive either IPX066 or IR CD-LD in Part 1 of the study and then IPX066 in Part 2 (open-label extension).
11015555|NCT01130493|FG000|Participant Flow|IPX066 Conversion|All subjects were converted to IPX066 during an open-label period
11015556|NCT01130493|FG001|Participant Flow|IPX066-Open-label IPX066 Washout-CLE-OLE|IPX066 (Per Protocol: Part 1 Period 1), Open-label washout IPX066, CLE (Per Protocol: Part 1 Period 2), OLE (Per Protocol: Part 2)
11015557|NCT01130493|FG002|Participant Flow|CLE-Open Label IPX066 Washout-IPX066-OLE|CLE (Per Protocol: Part 1 Period 1), Open-label washout IPX066, IPX066 (Per Protocol: Part 1 Period 2), OLE (Per Protocol: Part 2)
11015558|NCT01130493|OG000|Outcome|IPX066|Participants who received IPX066 in either Period 1 or Period 2
11015559|NCT01130493|OG001|Outcome|CLE (Active Comparator)|Participants who received CLE in either Period 1 or Period 2
11015560|NCT01130493|OG000|Outcome|Number of Participants Who Preferred IPX066|Participants who completed both treatment periods and who had a preference for IPX066
11015561|NCT01130493|OG001|Outcome|Number of Participants Who Preferred CLE|Participants who completed both treatment periods and who had a preference for CLE
11015562|NCT01130493|OG002|Outcome|Number of Participants Who Had no Preference|Participants who completed both treatment periods and who did not indicate a preference for either treatment
11015563|NCT01130493|EG000|Reported Event|Dose Conversion|Participants were to be converted from stable doses of CLE to open-label IPX066 over a 6-week period
11015564|NCT01130493|EG001|Reported Event|IPX066|Participants first received 2 weeks of IPX066 followed by an approximate 7-day washout period of IPX066 treatment followed by another 2 weeks of CLE.
11015565|NCT01130493|EG002|Reported Event|CLE (Active Comparator)|Participants first received 2 weeks of CLE followed by an approximate 7-day washout period of IPX066 treatment followed by another 2 weeks of IPX066.
11015566|NCT01130493|EG003|Reported Event|Washout|Participants receive open-label IPX066 for 1 week
11015567|NCT01130532|BG000|Baseline|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
11015568|NCT01130532|BG001|Baseline|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
11015569|NCT01130532|BG002|Baseline|Placebo|Placebo for 12 weeks during double-blind treatment period.
11015570|NCT01130532|BG003|Baseline|Total|Total of all reporting groups
11015571|NCT01130532|FG000|Participant Flow|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
11015572|NCT01130532|FG001|Participant Flow|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
11015573|NCT01130532|FG002|Participant Flow|Placebo|Placebo for 12 weeks during double-blind treatment period.
11015574|NCT01130532|FG003|Participant Flow|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
11015575|NCT01130532|OG000|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
11015576|NCT01130532|OG001|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
11015577|NCT01130532|OG002|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
11015578|NCT01130532|OG000|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
11015579|NCT01130532|OG001|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
11015580|NCT01130532|OG002|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
11015581|NCT01130532|EG000|Reported Event|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
11015582|NCT01130532|EG001|Reported Event|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
11015583|NCT01130532|EG002|Reported Event|Placebo|Placebo for 12 weeks during double-blind treatment period.
11015584|NCT01130532|EG003|Reported Event|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
11015585|NCT01130597|BG000|Baseline|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
11015586|NCT01130597|FG000|Participant Flow|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
11015587|NCT01130597|OG000|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
11066152|NCT01390857|EG000|Reported Event|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
11015588|NCT01130597|EG000|Reported Event|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
11015589|NCT01130740|BG000|Baseline|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
11015590|NCT01130740|BG001|Baseline|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
11015591|NCT01130740|BG002|Baseline|Total|Total of all reporting groups
11015592|NCT01130740|FG000|Participant Flow|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
11015593|NCT01130740|FG001|Participant Flow|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
11015594|NCT01130740|OG000|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
11015595|NCT01130740|OG001|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
11015596|NCT01130740|EG000|Reported Event|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
11015597|NCT01130740|EG001|Reported Event|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
11015598|NCT01130831|BG000|Baseline|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
11015599|NCT01130831|FG000|Participant Flow|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
11015600|NCT01130831|OG000|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of >=3 months of treatment prior to receiving lanthanum carbonate treatment.
11015601|NCT01130831|OG000|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
11015602|NCT01130831|OG000|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
11015603|NCT01130831|OG000|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium-phosphorous product KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
11015604|NCT01130831|OG000|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium-phosphorous product levels KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
11015605|NCT01130831|OG000|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum phosphorous KDOQI target on lanthanum carbonate.
11015606|NCT01130831|OG000|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium KDOQI target on lanthanum carbonate.
11015607|NCT01130831|OG000|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium-phosphorous product KDOQI target on lanthanum carbonate.
11015608|NCT01130831|OG000|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum phosphate KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
11015609|NCT01130831|OG000|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the iPTH KDOQI target on lanthanum carbonate.
11015610|NCT01130831|OG000|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
11015611|NCT01130831|OG000|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy of >=3 months of treatment.
11015612|NCT01130831|OG000|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy for >=3 months prior.
11015613|NCT01130831|EG000|Reported Event|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
11015614|NCT01130844|BG000|Baseline|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015615|NCT01130844|BG001|Baseline|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015616|NCT01130844|BG002|Baseline|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015617|NCT01130844|BG003|Baseline|Total|Total of all reporting groups
11015618|NCT01130844|FG000|Participant Flow|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015619|NCT01130844|FG001|Participant Flow|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015620|NCT01130844|FG002|Participant Flow|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015621|NCT01130844|OG000|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015622|NCT01130844|OG001|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015623|NCT01130844|OG002|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015624|NCT01130844|OG000|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015625|NCT01130844|OG001|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015626|NCT01130844|OG002|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11341242|NCT03679975|BG000|Baseline|Subjects With ALS|"Subjects with a diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria will be administered a single dose of the Riluzole Oral Soluble Film (ROSF) 50 mg.~Riluzole Oral Soluble film (ROSF) 50 mg: Enrolled subjects will undergo an instrumental evaluation of swallowing safety before and after administration of a single dose of the ROSF formulation containing 50 mg of riluzole."
11015627|NCT01130844|EG000|Reported Event|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015628|NCT01130844|EG001|Reported Event|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015629|NCT01130844|EG002|Reported Event|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
11015630|NCT01130883|BG000|Baseline|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
11015631|NCT01130883|FG000|Participant Flow|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
11015632|NCT01130883|OG000|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
11015633|NCT01130883|EG000|Reported Event|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
11015634|NCT01130896|BG000|Baseline|MRI and Cardiac Devices|Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
11015635|NCT01130896|FG000|Participant Flow|MRI and Cardiac Devices|Clinically indicated MRI (all types) in patients with implanted pacemakers and implantable cardioverter-defibrillator (ICD)
11015636|NCT01130896|OG000|Outcome|MRI and Cardiac Devices|Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
11015637|NCT01130896|EG000|Reported Event|MRI and Cardiac Devices|Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
11015638|NCT01130974|BG000|Baseline|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
11015639|NCT01130974|BG001|Baseline|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
11015640|NCT01130974|BG002|Baseline|Total|Total of all reporting groups
11015641|NCT01130974|FG000|Participant Flow|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
11015642|NCT01130974|FG001|Participant Flow|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
11015643|NCT01130974|OG000|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
11015644|NCT01130974|OG001|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
11015645|NCT01130974|OG001|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
11015646|NCT01130974|EG000|Reported Event|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
11015647|NCT01130974|EG001|Reported Event|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
11015648|NCT01131052|BG000|Baseline|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
11015649|NCT01131052|BG001|Baseline|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
11015650|NCT01131052|BG002|Baseline|Total|Total of all reporting groups
11015651|NCT01131052|FG000|Participant Flow|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
11015652|NCT01131052|FG001|Participant Flow|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
11015653|NCT01131052|OG000|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
11015654|NCT01131052|OG001|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
11015655|NCT01131052|EG000|Reported Event|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
11015656|NCT01131052|EG001|Reported Event|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
11015657|NCT01131065|BG000|Baseline|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
11015658|NCT01131065|FG000|Participant Flow|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
11015659|NCT01131065|OG000|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
11015660|NCT01131065|EG000|Reported Event|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
11015661|NCT01131078|BG000|Baseline|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
11015662|NCT01131078|BG001|Baseline|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
11015663|NCT01131078|BG002|Baseline|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
11015664|NCT01131078|BG003|Baseline|Total|Total of all reporting groups
11015665|NCT01131078|FG000|Participant Flow|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal.
11015666|NCT01131078|FG001|Participant Flow|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
11015667|NCT01131078|FG002|Participant Flow|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
11341243|NCT03679975|FG000|Participant Flow|Patients With ALS With Single 50 mg Dose ROSF|"Single group of patients with a diagnosis of probable or definite ALS in accordance with the Revised El-Escorial Criteria.~They participated in a Videofluoroscopic Swallowing Study (VFSS) with 11 bolus trials and were scored by two independent raters on the Penetration Aspiration Scale (PAS). They were then given a single dose of 50 mg Riluzole Oral Film, and the Videofluoroscopic Swallowing Study was repeated at three minutes after dosing."
10886212|NCT00492726|EG000|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
11015668|NCT01131078|OG000|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
11015669|NCT01131078|OG001|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
11015670|NCT01131078|OG002|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
11015671|NCT01131078|OG001|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal..
11015672|NCT01131078|OG001|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
11015673|NCT01131078|EG000|Reported Event|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
11015674|NCT01131078|EG001|Reported Event|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
11015675|NCT01131078|EG002|Reported Event|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
11015676|NCT01131104|BG000|Baseline|Cohort 1|Participants with NAION who have used PDE5 inhibitors
11015677|NCT01131104|FG000|Participant Flow|Enrolled Set|Enrolled participants who met inclusion/exclusion criteria and had physician-diagnosed NAION with a known date of onset.
11015678|NCT01131104|OG000|Outcome|Cohort 1|Participants with NAION who have used PDE5 inhibitors
11015679|NCT01131104|EG000|Reported Event|Cohort 1|Participants with NAION who have used PDE5 inhibitors.
11015680|NCT01131130|BG000|Baseline|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
11015681|NCT01131130|FG000|Participant Flow|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
11015682|NCT01131130|OG000|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
11015683|NCT01131130|OG001|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
11015684|NCT01131130|OG001|Outcome|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
11015685|NCT01131130|EG000|Reported Event|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
11015686|NCT01131130|EG001|Reported Event|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
11015687|NCT01131130|EG002|Reported Event|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
11015688|NCT01131182|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period. All participants as treated population, n=507.
11015689|NCT01131182|BG001|Baseline|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. All participants as treated population, n=514.
11015690|NCT01131182|BG002|Baseline|Total|Total of all reporting groups
11015691|NCT01131182|FG000|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period
11015692|NCT01131182|FG001|Participant Flow|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription
11015693|NCT01131182|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
11015694|NCT01131182|OG001|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
11015695|NCT01131182|EG000|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
11015696|NCT01131182|EG001|Reported Event|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
11015697|NCT01131260|BG000|Baseline|Open Group|S31 monitors in the open mode displayed ECG ST-segment information intended for use when uncertain fetal heart-rate patterns were detected. Management of the labor and delivery for women in this group was dictated by the ST-segment analysis guidelines
11015698|NCT01131260|BG001|Baseline|Masked Group|The masked S31 monitors functioned as conventional electronic fetal heart-rate monitors. The care of patients in the masked group was managed at the discretion of the attending physician or midwife.
11015699|NCT01131260|BG002|Baseline|Total|Total of all reporting groups
11015700|NCT01131260|FG000|Participant Flow|Open Group|S31 monitors in the open mode displayed ECG ST-segment information intended for use when uncertain fetal heart-rate patterns were detected. Management of the labor and delivery for women in this group was dictated by the ST-segment analysis guidelines
11015701|NCT01131260|FG001|Participant Flow|Masked Group|The masked S31 monitors functioned as conventional electronic fetal heart-rate monitors. The care of patients in the masked group was managed at the discretion of the attending physician or midwife.
11015702|NCT01131260|OG000|Outcome|Open Group|S31 monitors in the open mode displayed ECG ST-segment information intended for use when uncertain fetal heart-rate patterns were detected. Management of the labor and delivery for women in this group was dictated by the ST-segment analysis guidelines
11015703|NCT01131260|OG001|Outcome|Masked Group|The masked S31 monitors functioned as conventional electronic fetal heart-rate monitors. The care of patients in the masked group was managed at the discretion of the attending physician or midwife.
11015704|NCT01131260|OG000|Outcome|Open Group|"• Fetal STAN monitor electrode inserted and data available to caregivers~fetal STAN monitor: The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG."
11015705|NCT01131260|OG001|Outcome|Masked Group|"•Fetal STAN monitor electrode inserted, but data masked to the caregivers~fetal STAN monitor: The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG."
11015706|NCT01131260|EG000|Reported Event|Open Group|S31 monitors in the open mode displayed ECG ST-segment information intended for use when uncertain fetal heart-rate patterns were detected. Management of the labor and delivery for women in this group was dictated by the ST-segment analysis guidelines
11015707|NCT01131260|EG001|Reported Event|Masked Group|The masked S31 monitors functioned as conventional electronic fetal heart-rate monitors. The care of patients in the masked group was managed at the discretion of the attending physician or midwife.
11015708|NCT01131299|BG000|Baseline|Alpha Cyclodextrin & Placebo Participants|"Randomized subjects receiving alpha cyclodextrin~Alpha cyclodextrin: 2 g PO 3 times a day for 12- 14 weeks~Randomized subjects receiving placebo comparator~Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
11015709|NCT01131299|FG000|Participant Flow|Placebo First, Then Alpha Cyclodextrin|"Randomized subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks. After a one-week washout, the subjects will receive alpha cyclodextrin.~Alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks"
11015710|NCT01131299|FG001|Participant Flow|Alpha Cyclodextrin First, Then Placebo|"Subjects will receive alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks. After a one-week washout, the subjects will receive placebo.~Subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks"
11015711|NCT01131299|OG000|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
11015712|NCT01131299|OG001|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
11015713|NCT01131299|EG000|Reported Event|Entire Study Population|"Randomized subjects receiving active comparator~Alpha cyclodextrin: 2g PO 3 times a day for 12-14 weeks~Randomized subjects receiving placebo comparator~Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
11015714|NCT01131312|BG000|Baseline|Cytology|"Referred to colposcopy if cytology is high grade~Thinprep: Pap test"
11015715|NCT01131312|BG001|Baseline|Human Papillomavirus (HPV)|"Referred to colposcopy if cytology is high grade or HPV +~Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test"
11015716|NCT01131312|BG002|Baseline|Colposcopy|"All refer to colposcopy~Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva."
11015717|NCT01131312|BG003|Baseline|Total|Total of all reporting groups
11015718|NCT01131312|FG000|Participant Flow|Cytology|"Referred to colposcopy if cytology is high grade~Thinprep: Pap test"
11015719|NCT01131312|FG001|Participant Flow|Human Papillomavirus (HPV)|"Referred to colposcopy if cytology is high grade or HPV +~Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test"
11015720|NCT01131312|FG002|Participant Flow|Colposcopy|"All refer to colposcopy~Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva."
11015721|NCT01131312|OG000|Outcome|Cytology|"Referred to colposcopy if cytology is high grade~Thinprep: Pap test"
11015722|NCT01131312|OG001|Outcome|Human Papillomavirus (HPV)|"Referred to colposcopy if cytology is high grade or HPV +~Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test"
11015723|NCT01131312|OG002|Outcome|Colposcopy|"All refer to colposcopy~Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva."
11015724|NCT01131312|EG000|Reported Event|Cytology|"Referred to colposcopy if cytology is high grade~Thinprep: Pap test"
11015725|NCT01131312|EG001|Reported Event|Human Papillomavirus (HPV)|"Referred to colposcopy if cytology is high grade or HPV +~Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test"
11015726|NCT01131312|EG002|Reported Event|Colposcopy|"All refer to colposcopy~Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva."
11015727|NCT01131325|BG000|Baseline|Nilotinib|Participants received nilotinib 300 mg, BID po, every 12 hours in continuous 28-day cycle up to 2 years.
11015728|NCT01131325|FG000|Participant Flow|Nilotinib|Participants received nilotinib 300 milligram (mg) twice daily (bid) through the mouth (po), every 12 hours in a continuous 28-day cycle up to 2 years.
11015729|NCT01131325|OG000|Outcome|Nilotinib|Participants received nilotinib 300 mg, BID po, every 12 hours in continuous 28-day cycle up to 2 years.
11015730|NCT01131325|EG000|Reported Event|Nilotinib|Participants received nilotinib 300 mg, BID po, every 12 hours in continuous 28-day cycle up to 2 years.
11015731|NCT01131351|BG000|Baseline|Delamanid 250 mg BID + OBR|Participants received delamanid five 50 mg (250 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.
11015732|NCT01131351|BG001|Baseline|Delamanid 300 mg BID + OBR|Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.
11148366|NCT01863667|BG000|Baseline|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
10886213|NCT00492726|EG001|Reported Event|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
11015733|NCT01131351|BG002|Baseline|Total|Total of all reporting groups
11015734|NCT01131351|FG000|Participant Flow|Delamanid 250 mg BID + OBR|Participants received delamanid five 50 milligrams (mg) (250 mg) tablets, twice a day (BID), along with at least 2 additional anti-TB medications per optimized background regimen (OBR) for up to 28 weeks.
11015735|NCT01131351|FG001|Participant Flow|Delamanid 300 mg BID + OBR|Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.
11015736|NCT01131351|OG000|Outcome|Delamanid 250 mg BID + OBR|Participants received delamanid five 50 mg (250 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.
11015737|NCT01131351|OG001|Outcome|Delamanid 300 mg BID + OBR|Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.
11015738|NCT01131351|EG000|Reported Event|Delamanid 250 mg BID + OBR|Participants received delamanid five 50 mg (250 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.
11015739|NCT01131351|EG001|Reported Event|Delamanid 300 mg BID + OBR|Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.
11015740|NCT01131494|BG000|Baseline|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
11015741|NCT01131494|FG000|Participant Flow|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
11015742|NCT01131494|OG000|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
11015743|NCT01131494|OG001|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
11015744|NCT01131494|EG000|Reported Event|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
11015745|NCT01131507|BG000|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
11015746|NCT01131507|FG000|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
11015747|NCT01131507|OG000|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
11015748|NCT01131507|EG000|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
11148367|NCT01863667|BG001|Baseline|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
11148368|NCT01863667|BG002|Baseline|Total|Total of all reporting groups
11148369|NCT01863667|FG000|Participant Flow|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
11015749|NCT01131520|BG000|Baseline|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
11015750|NCT01131520|BG001|Baseline|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
11015751|NCT01131520|BG002|Baseline|Total|Total of all reporting groups
11015752|NCT01131520|FG000|Participant Flow|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
11015753|NCT01131520|FG001|Participant Flow|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
11015754|NCT01131520|OG000|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
11015755|NCT01131520|OG001|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
11015756|NCT01131520|EG000|Reported Event|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
11015757|NCT01131520|EG001|Reported Event|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
11015758|NCT01131585|BG000|Baseline|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
11015759|NCT01131585|BG001|Baseline|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
11015760|NCT01131585|BG002|Baseline|Total|Total of all reporting groups
11015761|NCT01131585|FG000|Participant Flow|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
11015762|NCT01131585|FG001|Participant Flow|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
11148370|NCT01863667|FG001|Participant Flow|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
11015763|NCT01131585|OG000|Outcome|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
11015764|NCT01131585|OG001|Outcome|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
11015765|NCT01131585|EG000|Reported Event|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
11015766|NCT01131585|EG001|Reported Event|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
11015767|NCT01131676|BG000|Baseline|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
11015768|NCT01131676|BG001|Baseline|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
11015769|NCT01131676|BG002|Baseline|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
11015770|NCT01131676|BG003|Baseline|Total|Total of all reporting groups
11015771|NCT01131676|FG000|Participant Flow|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
11148371|NCT01863667|OG000|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
11148372|NCT01863667|OG001|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
11015772|NCT01131676|FG001|Participant Flow|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
11015773|NCT01131676|FG002|Participant Flow|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
11015774|NCT01131676|OG000|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
11015775|NCT01131676|OG001|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
11348879|NCT04140890|FG000|Participant Flow|Treatment|Participants in the treatment group will be asked to meet with an occupational therapist in their home weekly over 12 weeks. Each session takes an hour. In the first session, the occupational therapist will introduce the program. In session 2, the therapist will discuss pain and pain management with the participant. In session 3-12, the therapist will help the participant to develop physical activity and healthy eating habits. In each session the participant will pick two healthy behaviors to turn them into a habit. The therapist will give the participant a workbook and teach the participant to track his/her progress. The focus of session 3-5 will be physical activity, and session 6-11 will be healthy eating. In the last session (session 12), the therapist will wrap up the program and help the participant to develop a maintenance plan.
11348880|NCT04140890|FG001|Participant Flow|Control|Participants in the control group will receive newsletters focused on general healthy aging topics over 12 weeks. With the exception of two, 1-page handouts covering PA and dietary recommendations, the weekly content will not overlap with the treatment content. Within 4 days of mailing the newsletter, a trained research assistant (RA) will call the participant, verify receipt of the newsletter, and ask them if they have any questions about the materials. The phone call will last ~15 minutes. Control condition participants receive no further intervention.
11015776|NCT01131676|OG002|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
11015777|NCT01131676|OG003|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
11015778|NCT01131676|EG000|Reported Event|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
11015779|NCT01131676|EG001|Reported Event|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
11015780|NCT01131676|EG002|Reported Event|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
11015781|NCT01132118|BG000|Baseline|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
11015782|NCT01132118|BG001|Baseline|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
11015783|NCT01132118|BG002|Baseline|Total|Total of all reporting groups
11015784|NCT01132118|FG000|Participant Flow|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
11015785|NCT01132118|FG001|Participant Flow|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
11015786|NCT01132118|OG000|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
11015787|NCT01132118|OG001|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
11015788|NCT01132118|EG000|Reported Event|Hydroxychloroquine|"Participants received hydroxychloroquine (HCQ) for 8 weeks.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
11015789|NCT01132118|EG001|Reported Event|Placebo|Participants received Placebo tablets for 8 weeks.
11148373|NCT01863667|EG000|Reported Event|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
11015790|NCT01132144|BG000|Baseline|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
11015791|NCT01132144|BG001|Baseline|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
11015792|NCT01132144|BG002|Baseline|Total|Total of all reporting groups
11015793|NCT01132144|FG000|Participant Flow|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
11015794|NCT01132144|FG001|Participant Flow|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
11015795|NCT01132144|OG000|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
11015796|NCT01132144|OG001|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
11015797|NCT01132144|OG000|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
11015798|NCT01132144|OG001|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
11015799|NCT01132144|EG000|Reported Event|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
11015800|NCT01132144|EG001|Reported Event|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
11015801|NCT01132313|BG000|Baseline|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
11015802|NCT01132313|BG001|Baseline|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
11015803|NCT01132313|BG002|Baseline|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015804|NCT01132313|BG003|Baseline|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015805|NCT01132313|BG004|Baseline|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015806|NCT01132313|BG005|Baseline|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015807|NCT01132313|BG006|Baseline|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015808|NCT01132313|BG007|Baseline|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015809|NCT01132313|BG008|Baseline|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015810|NCT01132313|BG009|Baseline|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015811|NCT01132313|BG010|Baseline|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
11015812|NCT01132313|BG011|Baseline|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
11015813|NCT01132313|BG012|Baseline|Total|Total of all reporting groups
11015814|NCT01132313|FG000|Participant Flow|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
11015815|NCT01132313|FG001|Participant Flow|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
11015816|NCT01132313|FG002|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015817|NCT01132313|FG003|Participant Flow|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015818|NCT01132313|FG004|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015819|NCT01132313|FG005|Participant Flow|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015820|NCT01132313|FG006|Participant Flow|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015821|NCT01132313|FG007|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015822|NCT01132313|FG008|Participant Flow|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015823|NCT01132313|FG009|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015824|NCT01132313|FG010|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
11015825|NCT01132313|FG011|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
11015826|NCT01132313|OG000|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
11015827|NCT01132313|OG001|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
11015828|NCT01132313|OG000|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015829|NCT01132313|OG001|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015830|NCT01132313|OG002|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11148374|NCT01863667|EG001|Reported Event|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
10887262|NCT00499486|EG000|Reported Event|Sirolimus|Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
11015831|NCT01132313|OG003|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015832|NCT01132313|OG004|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015833|NCT01132313|OG000|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015834|NCT01132313|OG001|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015835|NCT01132313|OG002|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015836|NCT01132313|OG003|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
11015837|NCT01132313|OG004|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
11015838|NCT01132313|OG002|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015839|NCT01132313|OG003|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015840|NCT01132313|OG004|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015841|NCT01132313|OG005|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015842|NCT01132313|OG006|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015843|NCT01132313|EG000|Reported Event|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
11015844|NCT01132313|EG001|Reported Event|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
11015845|NCT01132313|EG002|Reported Event|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015846|NCT01132313|EG003|Reported Event|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015847|NCT01132313|EG004|Reported Event|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015848|NCT01132313|EG005|Reported Event|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015849|NCT01132313|EG006|Reported Event|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015850|NCT01132313|EG007|Reported Event|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015851|NCT01132313|EG008|Reported Event|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015852|NCT01132313|EG009|Reported Event|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
11015853|NCT01132313|EG010|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
11015854|NCT01132313|EG011|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
11015855|NCT01132326|BG000|Baseline|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
11015856|NCT01132326|FG000|Participant Flow|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
11015857|NCT01132326|OG000|Outcome|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
11015858|NCT01132326|EG000|Reported Event|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
11015859|NCT01132378|BG000|Baseline|Median Parepatellar Approach or Minimidvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
11015860|NCT01132378|FG000|Participant Flow|Mini-midvastus Incision|"Total knee arthroplasty : staged bilateral total knee arthroplasty~Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini-midvastus approach in one knee and mini-Medial Parapatellar Approachthe in another knee (left or right)within no more than 7 days."
11015861|NCT01132378|OG000|Outcome|Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
11015862|NCT01132378|OG001|Outcome|Mini-midvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
11015863|NCT01132378|EG000|Reported Event|Midvastus or Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
11015864|NCT01132482|BG000|Baseline|Sildenafil|"Subjects will receive escalating doses of sildenafil~Sildenafil: During the course of the study, patients will receive 4 weeks of therapy: 28 days of placebo orally t.i.d. or 28 days of days of sildenafil orally t.i.d. Dosing of sildenafil will be escalated after the first week (20 mg orally t.i.d for the first week, then subjects will take 40 mg orally t.i.d. for 3 weeks). Patients not tolerating dose escalation will be discontinued from the study."
11015865|NCT01132482|BG001|Baseline|Placebo|"During the placebo arm, subjects receiving placebo will have sham dose escalation to maintain blinding.~Placebo: Patients receiving placebo will have sham dose escalation to maintain blinding."
11015866|NCT01132482|BG002|Baseline|Total|Total of all reporting groups
11015867|NCT01132482|FG000|Participant Flow|Sildenafil|"Subjects will receive escalating doses of sildenafil~Sildenafil: During the course of the study, patients will receive 4 weeks of therapy: 28 days of placebo orally t.i.d. or 28 days of days of sildenafil orally t.i.d. Dosing of sildenafil will be escalated after the first week (20 mg orally t.i.d for the first week, then subjects will take 40 mg orally t.i.d. for 3 weeks). Patients not tolerating dose escalation will be discontinued from the study."
11015868|NCT01132482|FG001|Participant Flow|Placebo|"During the placebo arm, subjects receiving placebo will have sham dose escalation to maintain blinding.~Placebo: Patients receiving placebo will have sham dose escalation to maintain blinding."
11015869|NCT01132482|OG000|Outcome|Sildenafil|"Subjects will receive escalating doses of sildenafil~Sildenafil: During the course of the study, patients will receive 4 weeks of therapy: 28 days of placebo orally t.i.d. or 28 days of days of sildenafil orally t.i.d. Dosing of sildenafil will be escalated after the first week (20 mg orally t.i.d for the first week, then subjects will take 40 mg orally t.i.d. for 3 weeks). Patients not tolerating dose escalation will be discontinued from the study."
11015870|NCT01132482|OG001|Outcome|Placebo|"During the placebo arm, subjects receiving placebo will have sham dose escalation to maintain blinding.~Placebo: Patients receiving placebo will have sham dose escalation to maintain blinding."
11015871|NCT01132482|EG000|Reported Event|Sildenafil|"Subjects will receive escalating doses of sildenafil~Sildenafil: During the course of the study, patients will receive 4 weeks of therapy: 28 days of placebo orally t.i.d. or 28 days of days of sildenafil orally t.i.d. Dosing of sildenafil will be escalated after the first week (20 mg orally t.i.d for the first week, then subjects will take 40 mg orally t.i.d. for 3 weeks). Patients not tolerating dose escalation will be discontinued from the study."
11015872|NCT01132482|EG001|Reported Event|Placebo|"During the placebo arm, subjects receiving placebo will have sham dose escalation to maintain blinding.~Placebo: Patients receiving placebo will have sham dose escalation to maintain blinding."
11015873|NCT01132495|BG000|Baseline|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
11015874|NCT01132495|BG001|Baseline|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
11015875|NCT01132495|BG002|Baseline|Cohort B - Follow-up|Observation with treatment based on physician preference
11015876|NCT01132495|BG003|Baseline|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data.
11015877|NCT01132495|BG004|Baseline|Total|Total of all reporting groups
11015878|NCT01132495|FG000|Participant Flow|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
11015879|NCT01132495|FG001|Participant Flow|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
11015880|NCT01132495|FG002|Participant Flow|Cohort B - Follow-up|Observation with treatment based on physician preference
11015881|NCT01132495|FG003|Participant Flow|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
11015882|NCT01132495|OG000|Outcome|Cohort A - PCI Plus OMT|PCI plus optimal medical treatment - Stenting plus OMT: FFR guided PCI, plus OMT
11015883|NCT01132495|OG001|Outcome|Cohort A - OMT Alone|Optimal medical treatment alone - Standard of care: OMT alone
11015884|NCT01132495|OG000|Outcome|Cohort A: PCI Plus OMT|"Patient with at least one hemodynamically significant stenosis (FFR, ≤0.80)~PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
11015885|NCT01132495|OG001|Outcome|Cohort A: OMT Alone|"Patient with at least one hemodynamically significant stenosis (FFR, ≤0.80)~Optimal medical treatment alone~OMT: OMT alone"
11015886|NCT01132495|OG002|Outcome|Cohort B: Registry Cohort|Patients in whom all stenoses had an FFR >0.80 were entered into a registry
11015887|NCT01132495|EG000|Reported Event|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
11015888|NCT01132495|EG001|Reported Event|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
11015889|NCT01132495|EG002|Reported Event|Cohort B - Follow-up|Observation with treatment based on physician preference
11015890|NCT01132495|EG003|Reported Event|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
11015891|NCT01132508|BG000|Baseline|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
11015892|NCT01132508|FG000|Participant Flow|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
11015893|NCT01132508|OG000|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
11015894|NCT01132508|EG000|Reported Event|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
11015895|NCT01132547|BG000|Baseline|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
11015896|NCT01132547|BG001|Baseline|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
11015897|NCT01132547|BG002|Baseline|Total|Total of all reporting groups
11015898|NCT01132547|FG000|Participant Flow|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
11015899|NCT01132547|FG001|Participant Flow|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
11015900|NCT01132547|OG000|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
11015901|NCT01132547|OG001|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
11015902|NCT01132547|EG000|Reported Event|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
11015903|NCT01132547|EG001|Reported Event|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
11015904|NCT01132612|BG000|Baseline|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
11015905|NCT01132612|BG001|Baseline|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
11015906|NCT01132612|BG002|Baseline|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
11015907|NCT01132612|BG003|Baseline|Total|Total of all reporting groups
11015908|NCT01132612|FG000|Participant Flow|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
11015909|NCT01132612|FG001|Participant Flow|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
11015910|NCT01132612|FG002|Participant Flow|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
11015911|NCT01132612|OG000|Outcome|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
11015912|NCT01132612|OG001|Outcome|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
11015913|NCT01132612|OG002|Outcome|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
11015914|NCT01132612|EG000|Reported Event|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
11015915|NCT01132612|EG001|Reported Event|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
11015916|NCT01132612|EG002|Reported Event|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
11015917|NCT01132651|BG000|Baseline|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
11015918|NCT01132651|BG001|Baseline|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
11015919|NCT01132651|BG002|Baseline|Total|Total of all reporting groups
11015920|NCT01132651|FG000|Participant Flow|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
11015921|NCT01132651|FG001|Participant Flow|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
11015922|NCT01132651|OG000|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
11015923|NCT01132651|OG001|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
11015924|NCT01132651|EG000|Reported Event|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
11015925|NCT01132651|EG001|Reported Event|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
11015926|NCT01132664|BG000|Baseline|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
11015927|NCT01132664|BG001|Baseline|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
11015928|NCT01132664|BG002|Baseline|Phase II - 100mg|Patients in the phase II only expansion cohort who received 100 mg of buparlisib - investigational drug
11015929|NCT01132664|BG003|Baseline|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
11015930|NCT01132664|BG004|Baseline|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
11015931|NCT01132664|BG005|Baseline|Total|Total of all reporting groups
11015932|NCT01132664|FG000|Participant Flow|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
11015933|NCT01132664|FG001|Participant Flow|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
11015934|NCT01132664|FG002|Participant Flow|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib dose escalation were included in phase II and received 100 mg of investigational drug - buparsilib
11015935|NCT01132664|FG003|Participant Flow|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
11015936|NCT01132664|FG004|Participant Flow|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
11015937|NCT01132664|OG000|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
11015938|NCT01132664|OG001|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
11015939|NCT01132664|OG002|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
11015940|NCT01132664|OG003|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
11015941|NCT01132664|OG004|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
11015942|NCT01132664|EG000|Reported Event|Phase Ib Dose Escalation 50 mg/Day|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug.
11015943|NCT01132664|EG001|Reported Event|Phase Ib Dose Escalation 100 mg/Day|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
11015944|NCT01132664|EG002|Reported Event|Phase II Dose Expansion 100 mg/Day|Patients in the phase II expansion + patients from phase Ib dose escalation who received 100 mg/day of buparlisib - investigational drug
11015945|NCT01132664|EG003|Reported Event|BM Cohort 80 mg/Day|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
11015946|NCT01132664|EG004|Reported Event|BM Cohort 100 mg/Day|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
11015947|NCT01132690|BG000|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
11015948|NCT01132690|BG001|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
11015949|NCT01132690|BG002|Baseline|Total|Total of all reporting groups
11015950|NCT01132690|FG000|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
11015951|NCT01132690|FG001|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
11015952|NCT01132690|OG000|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
11015953|NCT01132690|OG001|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
11015954|NCT01132690|EG000|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
11015955|NCT01132690|EG001|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
11015956|NCT01132755|BG000|Baseline|Patients Who Require Diagnostic Laparoscopy|Diagnostic peritoneal lavage will be performed at the time of laparoscopy utilizing a Veress needle/Seldinger technique to insert a peritoneal dialysis catheter. This is not a new technique. The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon.
11066153|NCT01390870|BG000|Baseline|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
11066154|NCT01390870|FG000|Participant Flow|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
11015957|NCT01132755|FG000|Participant Flow|Patients Who Require Diagnostic Laparoscopy|"Diagnostic peritoneal lavage will be performed at the time of laparoscopy utilizing a Veress needle/Seldinger technique to insert a peritoneal dialysis catheter. This is not a new technique. The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon.~Diagnostic peritoneal lavage: The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon. Caudal traction will be applied to the abdominal wall to provide a firm abdominal wall to insert the needle through, minimizing the peritoneum from tenting down closer to visceral structures. Intraperitoneal placement of the catheter will be confirmed by injection of saline into the needle with no resistance and with the saline in the hub of the needle falling into the peritoneal cavity spontaneously. A guide wire will be placed through the Veress and utilizing the Seldinger technique, a 9Fr peritoneal catheter will be placed."
11015958|NCT01132755|OG000|Outcome|Patients Who Require Diagnostic Laparoscopy|Diagnostic peritoneal lavage will be performed at the time of laparoscopy utilizing a Veress needle/Seldinger technique to insert a peritoneal dialysis catheter. This is not a new technique. The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon.
11015959|NCT01132755|EG000|Reported Event|Patients Who Require Diagnostic Laparoscopy|Diagnostic peritoneal lavage will be performed at the time of laparoscopy utilizing a Veress needle/Seldinger technique to insert a peritoneal dialysis catheter. This is not a new technique. The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon.
11015960|NCT01132807|BG000|Baseline|Treatment (ABVD x2 Cycles)|"Therapy consisted of 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. A cycle is 28 days.>>~Doxorubicin 25 mg/m2 IV on Days 1 and 15>>~Bleomycin 10 units/m2 IV on Days 1 and 15>>~Vinblastine 6 mg/m2 IV on Days 1 and 15>>~Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15>> >> PET/CT central review (cycle 2, days 23-25). Patients with a negative PET/CT (Deauville 1, 2, or 3) received 2 additional cycles of ABVD. >> >> Patients with positive PET received 2-21 day cycles of 3060-cGy involved-field RT (IFRT) and escalated BEACOPP:>>~Bleomycin 10 units/m2 IV on Day 8>> Etoposide 200 mg/m2 IV over 60 minutes on Days 1, 2 and 3 >> Doxorubicin 35 mg/m2 IV on Day 1 >> Cyclophosphamide 1250 mg/m2 IV over 60 minutes on Day 1 >> Vincristine 1.4 mg/m2 (maximum 2 mg) IV on Day 8 >> Procarbazine 100 mg/m2 (rounded to nearest 50 mg) orally on Days 1-7>> Prednisone 40 mg/m2 (rounded to nearest 5 mg) orally on Days 1-14"
11015961|NCT01132807|FG000|Participant Flow|Only Initial ABVD Treatment|"Therapy consisted of 2 initial cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. A cycle is 28 days.>~Doxorubicin 25 mg/m2 IV on Days 1 and 15>~Bleomycin 10 units/m2 IV on Days 1 and 15>~Vinblastine 6 mg/m2 IV on Days 1 and 15>~Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15"
11015962|NCT01132807|FG001|Participant Flow|Treatment (ABVD:Additional 2 Cycles)|"Therapy consisted of an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. A cycle is 28 days.>~Doxorubicin 25 mg/m2 IV on Days 1 and 15>~Bleomycin 10 units/m2 IV on Days 1 and 15>~Vinblastine 6 mg/m2 IV on Days 1 and 15>~Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15>~Patients underwent a PET/CT central review (cycle 2, days 23-25) and received an additional 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle."
11015963|NCT01132807|FG002|Participant Flow|Escalated BEACOPP and Involved Field Radiation Therapy|"Therapy consisted of 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. >~Doxorubicin 25 mg/m2 IV on Days 1 and 15>~Bleomycin 10 units/m2 IV on Days 1 and 15>~Vinblastine 6 mg/m2 IV on Days 1 and 15>~Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15> >> > >> Patients underwent a PET/CT central review (cycle 2, days 23-25) and received an additional 2-21 day cycles of 3060-cGy involved-field RT (IFRT) and escalated BEACOPP:> >> > >> Bleomycin 10 units/m2 IV on Day 8> >> Etoposide 200 mg/m2 IV over 60 minutes on Days 1, 2 and 3 > >> Doxorubicin 35 mg/m2 IV on Day 1 > >> Cyclophosphamide 1250 mg/m2 IV over 60 minutes on Day 1 > >> Vincristine 1.4 mg/m2 (maximum 2 mg) IV on Day 8 > >> Procarbazine 100 mg/m2 (rounded to nearest 50 mg) orally on Days 1-7>~Prednisone 40 mg/m2 (rounded to nearest 5 mg) orally on Days 1-14"
11015964|NCT01132807|OG000|Outcome|Treatment (ABVD: 4 Cycles)|"Therapy consisted of 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. A cycle is 28 days.~Doxorubicin 25 mg/m2 IV on Days 1 and 15~Bleomycin 10 units/m2 IV on Days 1 and 15~Vinblastine 6 mg/m2 IV on Days 1 and 15~Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15~PET/CT central review (cycle 2, days 23-25). Patients with a negative PET/CT (Deauville 1, 2, or 3) received 2 additional cycles of ABVD."
11015965|NCT01132807|OG000|Outcome|Treatment (ABVD:4 Cycles)|"Therapy consisted of 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. A cycle is 28 days.~Doxorubicin 25 mg/m2 IV on Days 1 and 15~Bleomycin 10 units/m2 IV on Days 1 and 15~Vinblastine 6 mg/m2 IV on Days 1 and 15~Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15~PET/CT central review (cycle 2, days 23-25). Patients with a negative PET/CT (Deauville 1, 2, or 3) received 2 additional cycles of ABVD."
11015966|NCT01132807|OG001|Outcome|Escalated BEACOPP and Involved Field Radiation Therapy|"Therapy consisted of 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. A cycle is 28 days.~Doxorubicin 25 mg/m2 IV on Days 1 and 15~Bleomycin 10 units/m2 IV on Days 1 and 15~Vinblastine 6 mg/m2 IV on Days 1 and 15~Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15~PET/CT central review (cycle 2, days 23-25). Patients with positive PET received 2-21 day cycles of 3060-cGy involved-field RT (IFRT) and escalated BEACOPP:~>~> Bleomycin 10 units/m2 IV on Day 8~> Etoposide 200 mg/m2 IV over 60 minutes on Days 1, 2 and 3~> Doxorubicin 35 mg/m2 IV on Day 1~> Cyclophosphamide 1250 mg/m2 IV over 60 minutes on Day 1~> Vincristine 1.4 mg/m2 (maximum 2 mg) IV on Day 8~> Procarbazine 100 mg/m2 (rounded to nearest 50 mg) orally on Days 1-7~> Prednisone 40 mg/m2 (rounded to nearest 5 mg) orally on Days 1-14"
11015967|NCT01132807|EG000|Reported Event|Only Initial Treatment (ABVD x2 Cycles)|Prednisone 40 mg/m2 (rounded to nearest 5 mg) orally on Days 1-14
11015968|NCT01132807|EG001|Reported Event|Treatment (ABVD:4 Cycles)|"Therapy consisted of 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. A cycle is 28 days.~Doxorubicin 25 mg/m2 IV on Days 1 and 15 Bleomycin 10 units/m2 IV on Days 1 and 15 Vinblastine 6 mg/m2 IV on Days 1 and 15 Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15~PET/CT central review (cycle 2, days 23-25). Patients with a negative PET/CT (Deauville 1, 2, or 3) received 2 additional cycles of ABVD."
11015969|NCT01132807|EG002|Reported Event|Escalated BEACOPP and Involved Field Radiation Therapy|"Therapy consisted of 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15 of each cycle. A cycle is 28 days.~Doxorubicin 25 mg/m2 IV on Days 1 and 15 Bleomycin 10 units/m2 IV on Days 1 and 15 Vinblastine 6 mg/m2 IV on Days 1 and 15 Dacarbazine 375 mg/m2 IV infusion on Days 1 and 15~PET/CT central review (cycle 2, days 23-25). Patients with positive PET received 2-21 day cycles of 3060-cGy involved-field RT (IFRT) and escalated BEACOPP:~Bleomycin 10 units/m2 IV on Day 8 Etoposide 200 mg/m2 IV over 60 minutes on Days 1, 2 and 3 Doxorubicin 35 mg/m2 IV on Day 1 Cyclophosphamide 1250 mg/m2 IV over 60 minutes on Day 1 Vincristine 1.4 mg/m2 (maximum 2 mg) IV on Day 8 Procarbazine 100 mg/m2 (rounded to nearest 50 mg) orally on Days 1-7 Prednisone 40 mg/m2 (rounded to nearest 5 mg) orally on Days 1-14"
11015970|NCT01132820|BG000|Baseline|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
11015971|NCT01132820|FG000|Participant Flow|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
11015972|NCT01132820|OG000|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
11015973|NCT01132820|EG000|Reported Event|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
11015974|NCT01132846|BG000|Baseline|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
11015975|NCT01132846|BG001|Baseline|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
11015976|NCT01132846|BG002|Baseline|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
11015977|NCT01132846|BG003|Baseline|Total|Total of all reporting groups
11015978|NCT01132846|FG000|Participant Flow|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
11015979|NCT01132846|FG001|Participant Flow|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
11015980|NCT01132846|FG002|Participant Flow|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
11015981|NCT01132846|OG000|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
11015982|NCT01132846|OG001|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
11015983|NCT01132846|OG002|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
11015984|NCT01132846|OG001|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
11015985|NCT01132846|OG002|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
11015986|NCT01132846|EG000|Reported Event|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
11015987|NCT01132846|EG001|Reported Event|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
11015988|NCT01132846|EG002|Reported Event|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
11015989|NCT01133067|BG000|Baseline|Total Cohort|Single-arm Prospective cohort
11015990|NCT01133067|FG000|Participant Flow|Total Cohort|Single-arm Prospective cohort
11015991|NCT01133067|OG000|Outcome|Total Cohort|Single-arm Prospective cohort
11015992|NCT01133067|EG000|Reported Event|Total Cohort|Single-arm Prospective cohort
11015993|NCT01133158|BG000|Baseline|Rituximab, Bendamustine, Mitoxantrone, Dexamethasone|"Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona~Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv"
11015994|NCT01133158|FG000|Participant Flow|Rituximab, Bendamustine, Mitoxantrone, Dexamethasone|"Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona~Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv"
11015995|NCT01133158|OG000|Outcome|Induction Rituximab, Bendamustine, Mitoxantrone, Dexamethasone|"Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona~Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv"
11015996|NCT01133158|OG001|Outcome|Maintenance Rituximab|"Patient who had response to induction will receive Rituximab in maintenance~Rituximab: 375 mg / m2 every three months"
11015997|NCT01133158|OG000|Outcome|R-BMD|"Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years~Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv"
11015998|NCT01133158|EG000|Reported Event|Rituximab, Bendamustine, Mitoxantrone, Dexamethasone|"Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona~Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv~Patients with response will receive Rituximab in maintenance: 375 mg / m2 every three months"
11015999|NCT01133171|BG000|Baseline|Dashboard Plus Nurse|
11016000|NCT01133171|BG001|Baseline|Nurse Alone|
11016001|NCT01133171|BG002|Baseline|Control|
11016002|NCT01133171|BG003|Baseline|Total|Total of all reporting groups
11016003|NCT01133171|FG000|Participant Flow|Dashboard Plus Nurse|
11016004|NCT01133171|FG001|Participant Flow|Nurse Alone|
11016005|NCT01133171|FG002|Participant Flow|Control|
11016006|NCT01133171|OG000|Outcome|Dashboard Plus Nurse|
11016007|NCT01133171|OG001|Outcome|Nurse Alone|
11016008|NCT01133171|OG002|Outcome|Control|
11016009|NCT01133171|EG000|Reported Event|Dashboard Plus Nurse|
11016010|NCT01133171|EG001|Reported Event|Nurse Alone|
11016011|NCT01133171|EG002|Reported Event|Control|
10886214|NCT00492752|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
11016012|NCT01133275|BG000|Baseline|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
11016013|NCT01133275|FG000|Participant Flow|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
11016014|NCT01133275|OG000|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
11016015|NCT01133275|EG000|Reported Event|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
11016016|NCT01133379|BG000|Baseline|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
11016017|NCT01133379|BG001|Baseline|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
11016018|NCT01133379|BG002|Baseline|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
11016019|NCT01133379|BG003|Baseline|Total|Total of all reporting groups
11016020|NCT01133379|FG000|Participant Flow|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
11016021|NCT01133379|FG001|Participant Flow|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
11016022|NCT01133379|FG002|Participant Flow|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
11016023|NCT01133379|OG000|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
11016024|NCT01133379|OG001|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
10886215|NCT00492752|BG001|Baseline|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
10886216|NCT00492752|BG002|Baseline|Total|Total of all reporting groups
11016025|NCT01133379|OG002|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
11016026|NCT01133379|EG000|Reported Event|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
11016027|NCT01133379|EG001|Reported Event|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
11016028|NCT01133379|EG002|Reported Event|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
11016029|NCT01133392|BG000|Baseline|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence ABAB.
11016030|NCT01133392|BG001|Baseline|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence BABA.
11016031|NCT01133392|BG002|Baseline|Total|Total of all reporting groups
11016032|NCT01133392|FG000|Participant Flow|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence ABAB. There was an interval of approximately 4 to 7 days between doses.
11016033|NCT01133392|FG001|Participant Flow|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence BABA. There was an interval of approximately 4 to 7 days between doses.
11016034|NCT01133392|OG000|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
11016035|NCT01133392|OG001|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
11016036|NCT01133392|EG000|Reported Event|Insulin Lispro A|Insulin lispro A formulation (Treatment A, test - 2 occasions)
11016037|NCT01133392|EG001|Reported Event|Insulin Lispro B|Insulin lispro B formulation (Treatment B, reference - 2 occasions)
11016038|NCT01133405|BG000|Baseline|Cohort A (Part 1): Sequence 1|Participants received Placebo, 15 milligram (mg) LY2886721 and 35 mg LY2886721 orally as per the dosing sequence in each period.
11016039|NCT01133405|BG001|Baseline|Cohort A (Part 1): Sequence 2|Participants received 1 mg LY2886721, 15 mg LY2886721 and placebo orally as per the dosing sequence in each period.
11016040|NCT01133405|BG002|Baseline|Cohort A (Part 1): Sequence 3|Participants received 1 mg LY2886721, placebo and 35 mg LY2886721 orally as per the dosing sequence in each period.
11016041|NCT01133405|BG003|Baseline|Cohort B (Part 1): Sequence 1|Participants received 7 mg LY2886721, 25 mg LY2886721 and placebo and orally as per the dosing sequence in each period.
11016042|NCT01133405|BG004|Baseline|Cohort B (Part 1): Sequence 2|Participants received 7 mg LY2886721, placebo and 7 mg LY2886721 (fed state) orally as per the dosing sequence in each period.
11016043|NCT01133405|BG005|Baseline|Cohort B (Part 1): Sequence 3|Participants received Placebo, 25 mg LY2886721 and 7 mg LY2886721 (fed state) orally as per the below dosing sequence in each period.
11016044|NCT01133405|BG006|Baseline|Cohort C (Part 2): 10mg LY2886721|Participants received a single 10 mg LY2886721 oral dose (low dose) in the fasted state.
11016045|NCT01133405|BG007|Baseline|Cohort C (Part 2): Placebo|.Participants received a single oral placebo dose in the fasted state.
11016046|NCT01133405|BG008|Baseline|Cohort D (Part 2): 35 mg LY2886721|Participants received a single 35 mg LY2886721 oral dose (high dose) in the fasted state.
11016047|NCT01133405|BG009|Baseline|Cohort D (Part 2): Placebo|Participants received a single oral placebo dose in the fasted state.
11016048|NCT01133405|BG010|Baseline|Total|Total of all reporting groups
11016049|NCT01133405|FG000|Participant Flow|Cohort A (Part 1) : Sequence 1|"Participants received Placebo, 15 milligram (mg) LY2886721 and 35 mg LY2886721 orally as per the below dosing sequence in each period.~Period 1: Placebo, Period 2: 15 mg LY2886721 and Period 3: 35 mg LY2886721."
11016050|NCT01133405|FG001|Participant Flow|Cohort A (Part 1): Sequence 2|"Participants received 1 mg LY2886721, 15 mg LY2886721 and placebo orally as per the below dosing sequence in each period.~Period 1: 1 mg LY2886721, Period 2: 15 mg LY2886721 and Period 3: Placebo."
11016051|NCT01133405|FG002|Participant Flow|Cohort A (Part 1): Sequence 3|"Participants received 1 mg LY2886721, placebo and 35 mg LY2886721 orally as per the below dosing sequence in each period.~Period 1: 1 mg LY2886721, Period 2: Placebo and Period 3: 35 mg LY2886721."
11016052|NCT01133405|FG003|Participant Flow|Cohort B (Part 1): Sequence 1|"Participants received 7 mg LY2886721, 25 mg LY2886721 and placebo and orally as per the below dosing sequence in each period.~Period 1: 7 mg LY2886721, Period 2: 25 mg LY2886721 and Period 3: Placebo."
11016053|NCT01133405|FG004|Participant Flow|Cohort B (Part 1): Sequence 2|"Participants received 7 mg LY2886721, placebo and 7 mg LY2886721 (fed state) orally as per the below dosing sequence in each period.~Period 1: 7 mg LY2886721 Period 2: Placebo and Period 3: 7 mg LY2886721 (fed state)."
11016054|NCT01133405|FG005|Participant Flow|Cohort B (Part 1): Sequence 3|"Participants received Placebo, 25 mg LY2886721 and 7 mg LY2886721 (fed state) orally as per the below dosing sequence in each period.~Period 1: Placebo, Period 2: 25 mg LY2886721 and Period 3: 7 mg LY2886721 (fed state)."
11016055|NCT01133405|FG006|Participant Flow|Cohort C (Part 2): 10mg LY2886721|Participants received a single 10 mg LY2886721 oral dose (low dose) in the fasted state.
11016056|NCT01133405|FG007|Participant Flow|Cohort C (Part 2): Placebo|Participants received a single oral placebo dose in the fasted state.
11016057|NCT01133405|FG008|Participant Flow|Cohort D (Part 2): 35 mg LY2886721|Participants received a single 35 mg LY2886721 oral dose (high dose) in the fasted state.
11016058|NCT01133405|FG009|Participant Flow|Cohort D (Part 2): Placebo|Participants received a single oral placebo dose in the fasted state.
11016059|NCT01133405|OG000|Outcome|Placebo (Part 1)|In a single 8-day period, participants received a single placebo oral dose after an overnight fast.
11016060|NCT01133405|OG001|Outcome|1 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast.
11016061|NCT01133405|OG002|Outcome|7 mg LY2886721 (Part 1 - Fed and Fasted)|"In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after completing breakfast (Fed).~In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast (Fasted)."
11016062|NCT01133405|OG003|Outcome|10 mg LY2886721 (Part 2)|Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
11016063|NCT01133405|OG004|Outcome|15 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast.
11016064|NCT01133405|OG005|Outcome|25 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast.
11016065|NCT01133405|OG006|Outcome|35 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast.
11016066|NCT01133405|OG007|Outcome|35 mg LY2886721 (Part 2)|Participants received a single 35-mg LY2886721 oral dose after an overnight fast.
11016067|NCT01133405|OG008|Outcome|Placebo (Part 2)|Participants received a single placebo oral dose after an overnight fast.
11016068|NCT01133405|OG000|Outcome|1 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast.
11016069|NCT01133405|OG001|Outcome|7 mg LY2886721 Fed (Part 1)|In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after completing breakfast.
11016070|NCT01133405|OG002|Outcome|7 mg LY2886721 Fasted (Part 1)|In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast.
11016071|NCT01133405|OG003|Outcome|15 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast.
11016072|NCT01133405|OG004|Outcome|25 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast.
11016073|NCT01133405|OG005|Outcome|35 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast.
11016074|NCT01133405|OG000|Outcome|10 mg LY2886721 (Part 2)|Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
11016075|NCT01133405|OG001|Outcome|35 mg LY2886721 (Part 2)|Participants received a single 35-mg LY2886721 oral dose by mouth after an overnight fast.
11016076|NCT01133405|OG001|Outcome|35 mg LY2886721 (Part 2)|Participants received a single 35-mg LY2886721 oral dose after an overnight fast.
11016077|NCT01133405|OG002|Outcome|Placebo (Part 2)|Participants received a single placebo oral dose after an overnight fast.
11016078|NCT01133405|EG000|Reported Event|Placebo (Part 1)|In a single 8-day period, participants received a single placebo oral dose after an overnight fast.
11016079|NCT01133405|EG001|Reported Event|1 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast.
11016080|NCT01133405|EG002|Reported Event|7 mg LY2886721 (Part 1 - Fed and Fasted)|"In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after breakfast (Fed).~In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast (Fasted)."
11016081|NCT01133405|EG003|Reported Event|10 mg LY2886721 (Part 2)|Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
11016082|NCT01133405|EG004|Reported Event|15 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast.
11016083|NCT01133405|EG005|Reported Event|25 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast.
11016084|NCT01133405|EG006|Reported Event|35 mg LY2886721 (Part 1)|In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast.
11016085|NCT01133405|EG007|Reported Event|35 mg LY2886721 (Part 2)|Participants received a single 35-mg LY2886721 oral dose after an overnight fast.
11016086|NCT01133405|EG008|Reported Event|Placebo (Part 2)|Participants received a single placebo oral dose after an overnight fast.
11016087|NCT01133418|BG000|Baseline|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
11016088|NCT01133418|BG001|Baseline|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
11016089|NCT01133418|BG002|Baseline|Total|Total of all reporting groups
11016090|NCT01133418|FG000|Participant Flow|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
11016091|NCT01133418|FG001|Participant Flow|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
11016092|NCT01133418|OG000|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
11016093|NCT01133418|OG001|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
11016094|NCT01133418|EG000|Reported Event|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
11016095|NCT01133418|EG001|Reported Event|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
11016096|NCT01133522|BG000|Baseline|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
11016097|NCT01133522|BG001|Baseline|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
11016098|NCT01133522|BG002|Baseline|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
11016099|NCT01133522|BG003|Baseline|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016100|NCT01133522|BG004|Baseline|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
11016101|NCT01133522|BG005|Baseline|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
11016102|NCT01133522|BG006|Baseline|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
11016103|NCT01133522|BG007|Baseline|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016104|NCT01133522|BG008|Baseline|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
11016105|NCT01133522|BG009|Baseline|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016106|NCT01133522|BG010|Baseline|Total|Total of all reporting groups
11016107|NCT01133522|FG000|Participant Flow|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
11016108|NCT01133522|FG001|Participant Flow|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly (QW) for 6 weeks.
11016109|NCT01133522|FG002|Participant Flow|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
11016110|NCT01133522|FG003|Participant Flow|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks (Q2W) for 6 weeks.
11016111|NCT01133522|FG004|Participant Flow|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
11016112|NCT01133522|FG005|Participant Flow|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks (Q4W) for 8 weeks.
11016113|NCT01133522|FG006|Participant Flow|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
11016114|NCT01133522|FG007|Participant Flow|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016115|NCT01133522|FG008|Participant Flow|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
11016116|NCT01133522|FG009|Participant Flow|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016117|NCT01133522|OG000|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
11016118|NCT01133522|OG001|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
11016119|NCT01133522|OG002|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
11016120|NCT01133522|OG003|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016121|NCT01133522|OG004|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
11016122|NCT01133522|OG005|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
11016123|NCT01133522|OG006|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
11016124|NCT01133522|OG007|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016125|NCT01133522|OG008|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
11016126|NCT01133522|OG009|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016127|NCT01133522|OG000|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
11016128|NCT01133522|OG001|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
11016129|NCT01133522|OG002|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016130|NCT01133522|OG003|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
11016131|NCT01133522|OG004|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
11016132|NCT01133522|OG005|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016133|NCT01133522|OG006|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016134|NCT01133522|EG000|Reported Event|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
11016135|NCT01133522|EG001|Reported Event|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
11016136|NCT01133522|EG002|Reported Event|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
11016137|NCT01133522|EG003|Reported Event|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016138|NCT01133522|EG004|Reported Event|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
11016139|NCT01133522|EG005|Reported Event|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
11016140|NCT01133522|EG006|Reported Event|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
11016141|NCT01133522|EG007|Reported Event|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016142|NCT01133522|EG008|Reported Event|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
11016143|NCT01133522|EG009|Reported Event|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
11016144|NCT01133626|BG000|Baseline|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
11225650|NCT02369848|EG000|Reported Event|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
11016145|NCT01133626|BG001|Baseline|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
11016146|NCT01133626|BG002|Baseline|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
11016147|NCT01133626|BG003|Baseline|Total|Total of all reporting groups
11016148|NCT01133626|FG000|Participant Flow|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
11016149|NCT01133626|FG001|Participant Flow|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
11016150|NCT01133626|FG002|Participant Flow|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
11016151|NCT01133626|OG000|Outcome|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
11016152|NCT01133626|OG001|Outcome|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
11016153|NCT01133626|OG002|Outcome|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
11016154|NCT01133626|EG000|Reported Event|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
11016155|NCT01133626|EG001|Reported Event|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
11016156|NCT01133626|EG002|Reported Event|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
11016157|NCT01133665|BG000|Baseline|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
11016158|NCT01133665|FG000|Participant Flow|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
11016159|NCT01133665|OG000|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
11016160|NCT01133665|EG000|Reported Event|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
11016161|NCT01133678|BG000|Baseline|Everolimus|"Everolimus 5 mg PO Daily for 2 21-day cycles~Everolimus: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel (175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Everolimus 5 mg PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose."
11016162|NCT01133678|BG001|Baseline|Placebo|"Placebo 5 mg PO Daily for 2 21-day cycles~Placebo: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel(175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Placebo PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose."
11016163|NCT01133678|BG002|Baseline|Total|Total of all reporting groups
11016164|NCT01133678|FG000|Participant Flow|Everolimus|"Everolimus 5 mg PO Daily for 2 21-day cycles~Everolimus: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel (175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Everolimus 5 mg PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose."
11016165|NCT01133678|FG001|Participant Flow|Placebo|"Placebo 5 mg PO Daily for 2 21-day cycles~Placebo: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel(175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Placebo PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose."
11016166|NCT01133678|OG000|Outcome|Everolimus|"Everolimus 5 mg PO Daily for 2 21-day cycles~Everolimus: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel (175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Everolimus 5 mg PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose."
11016167|NCT01133678|OG001|Outcome|Placebo|"Placebo 5 mg PO Daily for 2 21-day cycles~Placebo: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel(175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Placebo PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose."
11225651|NCT02369874|BG000|Baseline|Durvalumab + Tremelimumab|Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
11016168|NCT01133678|EG000|Reported Event|Everolimus|"Everolimus 5 mg PO Daily for 2 21-day cycles~Everolimus: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel (175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Everolimus 5 mg PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose."
11016169|NCT01133678|EG001|Reported Event|Placebo|"Placebo 5 mg PO Daily for 2 21-day cycles~Placebo: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel(175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Placebo PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose."
11016170|NCT01133704|BG000|Baseline|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
11016171|NCT01133704|BG001|Baseline|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
11016172|NCT01133704|BG002|Baseline|Total|Total of all reporting groups
11016173|NCT01133704|FG000|Participant Flow|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
11016174|NCT01133704|FG001|Participant Flow|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
11016175|NCT01133704|OG000|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
11016176|NCT01133704|OG001|Outcome|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
11016177|NCT01133704|EG000|Reported Event|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
11016178|NCT01133704|EG001|Reported Event|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
11016179|NCT01133756|BG000|Baseline|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016180|NCT01133756|BG001|Baseline|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016181|NCT01133756|BG002|Baseline|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016182|NCT01133756|BG003|Baseline|Total|Total of all reporting groups
11016183|NCT01133756|FG000|Participant Flow|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (area under the concentration-time curve [AUC] 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016184|NCT01133756|FG001|Participant Flow|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016185|NCT01133756|FG002|Participant Flow|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016186|NCT01133756|OG000|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016187|NCT01133756|OG001|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016188|NCT01133756|OG002|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016189|NCT01133756|EG000|Reported Event|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11225652|NCT02369874|BG001|Baseline|Durvalumab|Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
11016190|NCT01133756|EG001|Reported Event|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016191|NCT01133756|EG002|Reported Event|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
11016192|NCT01133821|BG000|Baseline|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
11016193|NCT01133821|BG001|Baseline|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
11016194|NCT01133821|BG002|Baseline|Total|Total of all reporting groups
11016195|NCT01133821|FG000|Participant Flow|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
11016196|NCT01133821|FG001|Participant Flow|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
11016197|NCT01133821|OG000|Outcome|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
11016198|NCT01133821|OG001|Outcome|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
11016199|NCT01133821|EG000|Reported Event|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
11016200|NCT01133821|EG001|Reported Event|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
11016201|NCT01133847|BG000|Baseline|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
11016202|NCT01133847|BG001|Baseline|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
11016203|NCT01133847|BG002|Baseline|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
11016204|NCT01133847|BG003|Baseline|Total|Total of all reporting groups
11016205|NCT01133847|FG000|Participant Flow|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
11016206|NCT01133847|FG001|Participant Flow|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
11016207|NCT01133847|FG002|Participant Flow|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
11016208|NCT01133847|OG000|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
11016209|NCT01133847|OG001|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
11016210|NCT01133847|OG002|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
11016211|NCT01133847|OG002|Outcome|Combined ADHD Treatment and Reading Instruction|"All interventions described in Reading Instruction and ADHD treatment arms:~All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training."
11016212|NCT01133847|EG000|Reported Event|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
11066155|NCT01390870|OG000|Outcome|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
11016213|NCT01133847|EG001|Reported Event|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
11016214|NCT01133847|EG002|Reported Event|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
11016215|NCT01133860|BG000|Baseline|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
11016216|NCT01133860|FG000|Participant Flow|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
11016217|NCT01133860|OG000|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
11016218|NCT01133860|OG000|Outcome|Eltrombopag|In patients with more than 100 x10e9 platelets/L at the end of therapy, we evaluated also the in vitro platelet aggregation after stimulation with adenosine diphosphate (5 and 20 mcM), collagen (5 and 20 mg/mL) and ristocetin (3 mg/mL) by the densitometric method of Born in native platelet rich plasma. The extent of platelet aggregation was measured 5 minutes after the addition of stimulating agents and results obtained in patients were compared with the normal ranges in the laboratories where the assay was performed. Results are reported as the number of patients with normal platelet aggregation.
11016219|NCT01133860|EG000|Reported Event|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
11016220|NCT01133977|BG000|Baseline|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016221|NCT01133977|BG001|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016222|NCT01133977|BG002|Baseline|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016223|NCT01133977|BG003|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016224|NCT01133977|BG004|Baseline|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016225|NCT01133977|BG005|Baseline|Total|Total of all reporting groups
11016226|NCT01133977|FG000|Participant Flow|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016227|NCT01133977|FG001|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016228|NCT01133977|FG002|Participant Flow|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016229|NCT01133977|FG003|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016230|NCT01133977|FG004|Participant Flow|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016231|NCT01133977|OG000|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit.
11016232|NCT01133977|OG001|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016233|NCT01133977|OG002|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016234|NCT01133977|OG000|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016235|NCT01133977|OG003|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016236|NCT01133977|OG004|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016237|NCT01133977|OG000|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016238|NCT01133977|OG001|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016239|NCT01133977|EG000|Reported Event|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11225653|NCT02369874|BG002|Baseline|Standard of Care (SoC)|Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.
11225654|NCT02369874|BG003|Baseline|Total|Total of all reporting groups
11225655|NCT02369874|FG000|Participant Flow|Durvalumab + Tremelimumab|Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
11225656|NCT02369874|FG001|Participant Flow|Durvalumab|Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
11016240|NCT01133977|EG001|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11225657|NCT02369874|FG002|Participant Flow|Standard of Care (SoC)|Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.
11225658|NCT02369874|OG000|Outcome|Durvalumab + Tremelimumab|Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
10886217|NCT00492752|FG000|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|"Participants randomized to Sorafenib treatment until unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
11225659|NCT02369874|OG001|Outcome|Durvalumab|Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
11225660|NCT02369874|OG002|Outcome|Standard of Care (SoC)|Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.
11016241|NCT01133977|EG002|Reported Event|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016242|NCT01133977|EG003|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016243|NCT01133977|EG004|Reported Event|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
11016244|NCT01134016|BG000|Baseline|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
11016245|NCT01134016|FG000|Participant Flow|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
11016246|NCT01134016|OG000|Outcome|Antroquinonol|Maximum Tolerable Dose for Antroquinonol
11016247|NCT01134016|OG000|Outcome|Tmax Day1: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
11016248|NCT01134016|OG001|Outcome|Tmax Day 1: 100 mg|Patient represent the time to reach the maximum plasma concentration after dose
11016249|NCT01134016|OG002|Outcome|Tmax Day 1: 200mg|Patient represent the time to reach the maximum plasma concentration after dose
11016250|NCT01134016|OG003|Outcome|Tmax Day 1: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
11016251|NCT01134016|OG004|Outcome|Tmax Day 1: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
11016252|NCT01134016|OG005|Outcome|Tmax Day 1 :600 mg|Patient represent the time to reach the maximum plasma concentration after dose
11016253|NCT01134016|OG006|Outcome|Tmax Day 28: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
11016254|NCT01134016|OG007|Outcome|Tmax Day 28: 100mg|Patient represent the time to reach the maximum plasma concentration after dose
11016255|NCT01134016|OG008|Outcome|Tmax Day 28: 200 mg|Patient represent the time to reach the maximum plasma concentration after dose
11016256|NCT01134016|OG009|Outcome|Tmax Day 28: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
11016257|NCT01134016|OG010|Outcome|Tmax Day 28: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
11016258|NCT01134016|OG011|Outcome|Tmax Day 28: 600mg|Patient represent the time to reach the maximum plasma concentration after dose
11225661|NCT02369874|EG000|Reported Event|Durvalumab + Tremelimumab|Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
11225662|NCT02369874|EG001|Reported Event|Durvalumab|Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
11016259|NCT01134016|OG000|Outcome|Half-life Time Day 1:50mg|The time of plasma concentration drops from maximum to half
11016260|NCT01134016|OG001|Outcome|Half-life Time Day 1: 100 mg|The time of plasma concentration drops from maximum to half
11016261|NCT01134016|OG002|Outcome|Half-life Time Day 1: 200mg|The time of plasma concentration drops from maximum to half
11016262|NCT01134016|OG003|Outcome|Half-life Time Day 1: 300mg|The time of plasma concentration drops from maximum to half
11225663|NCT02369874|EG002|Reported Event|Standard of Care (SoC)|Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.
11225664|NCT02369900|BG000|Baseline|Esmolol Infusion|"Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.~Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs~Esmolol"
11016263|NCT01134016|OG004|Outcome|Half-life Time Day 1: 450 mg|The time of plasma concentration drops from maximum to half
11016264|NCT01134016|OG005|Outcome|Half-life Time Day 1: 600 mg|The time of plasma concentration drops from maximum to half
11016265|NCT01134016|OG006|Outcome|Half-life Time Day 28: 50mg|The time of plasma concentration drops from maximum to half
11016266|NCT01134016|OG007|Outcome|Half-life Time Day 28:100 mg|The time of plasma concentration drops from maximum to half
11016267|NCT01134016|OG008|Outcome|Half-life Time Day 28: 200 mg|The time of plasma concentration drops from maximum to half
11016268|NCT01134016|OG009|Outcome|Half-life Time Day 28: 300 mg|The time of plasma concentration drops from maximum to half
11016269|NCT01134016|OG010|Outcome|Half-life Time Day 28: 450 mg|The time of plasma concentration drops from maximum to half
11016270|NCT01134016|OG011|Outcome|Half-life Time Day 28: 600mg|The time of plasma concentration drops from maximum to half
11016271|NCT01134016|OG000|Outcome|Cmax Day 1|the observed maximum plasma concentration after dosing on Day 1
11016272|NCT01134016|OG000|Outcome|Cmax Day 28|the observed maximum plasma concentration after dosing on Day 28
11016273|NCT01134016|OG000|Outcome|AUC0-t on Day 1|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 1
11016274|NCT01134016|OG000|Outcome|AUC0-t on Day 28|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 28
11016275|NCT01134016|OG000|Outcome|Tumer Responce at Per-protocol (PP) Population|All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST) of tumor size.
11016276|NCT01134016|EG000|Reported Event|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
11016277|NCT01134042|BG000|Baseline|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016278|NCT01134042|BG001|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016279|NCT01134042|BG002|Baseline|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016280|NCT01134042|BG003|Baseline|Total|Total of all reporting groups
11016281|NCT01134042|FG000|Participant Flow|FF 200 µg OD|Participants received FF 200 microgram (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening plus placebo via the DISKUS/ACCUHALER twice daily (BID), for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016282|NCT01134042|FG001|Participant Flow|FF/VI 200/25 µg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016283|NCT01134042|FG002|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016284|NCT01134042|OG000|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016285|NCT01134042|OG001|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016286|NCT01134042|OG002|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016287|NCT01134042|OG000|Outcome|FF 200 µg OD Arm|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016288|NCT01134042|EG000|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016289|NCT01134042|EG001|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016290|NCT01134042|EG002|Reported Event|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
11016291|NCT01134055|BG000|Baseline|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016292|NCT01134055|BG001|Baseline|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016293|NCT01134055|BG002|Baseline|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016294|NCT01134055|BG003|Baseline|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016295|NCT01134055|BG004|Baseline|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11066156|NCT01390870|EG000|Reported Event|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
11016296|NCT01134055|BG005|Baseline|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016297|NCT01134055|BG006|Baseline|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
11016298|NCT01134055|BG007|Baseline|Total|Total of all reporting groups
11016299|NCT01134055|FG000|Participant Flow|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016300|NCT01134055|FG001|Participant Flow|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 milligram/milliliter (mg/mL) TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016301|NCT01134055|FG002|Participant Flow|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016302|NCT01134055|FG003|Participant Flow|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016303|NCT01134055|FG004|Participant Flow|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11225665|NCT02369900|BG001|Baseline|Standard Care, Saline|"Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs~Saline"
11225666|NCT02369900|BG002|Baseline|Total|Total of all reporting groups
11016304|NCT01134055|FG005|Participant Flow|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016305|NCT01134055|FG006|Participant Flow|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
11016306|NCT01134055|OG000|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11066157|NCT01390909|BG000|Baseline|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
11016307|NCT01134055|OG001|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016308|NCT01134055|OG002|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016309|NCT01134055|OG003|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016310|NCT01134055|OG004|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016311|NCT01134055|OG005|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016312|NCT01134055|OG006|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
11016313|NCT01134055|OG003|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016314|NCT01134055|OG000|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016315|NCT01134055|OG001|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016316|NCT01134055|OG002|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016317|NCT01134055|OG003|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016318|NCT01134055|OG004|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016319|NCT01134055|EG000|Reported Event|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016320|NCT01134055|EG001|Reported Event|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016321|NCT01134055|EG002|Reported Event|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016322|NCT01134055|EG003|Reported Event|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016323|NCT01134055|EG004|Reported Event|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016324|NCT01134055|EG005|Reported Event|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
11016325|NCT01134055|EG006|Reported Event|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
11016326|NCT01134081|BG000|Baseline|CelTx™ & Free Gingival Grafts|CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
11016327|NCT01134081|FG000|Participant Flow|CelTx™ & Free Gingival Grafts|CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
11016328|NCT01134081|OG000|Outcome|CelTx™|Living bilayered cell therapy product
11016329|NCT01134081|OG001|Outcome|Free Gingival Grafts|Harvested tissue from palate
11016330|NCT01134081|OG000|Outcome|CelTx™|"Living bilayered cell therapy product~CelTx™: CelTx™ is a living bilayered cell therapy product. CelTx™ is constructed of Type I bovine collagen (extracted from bovine tendons and subsequently purified) and viable allogeneic human fibroblasts and keratinocytes isolated from human neonatal foreskin. This is applied once in the oral cavity."
11341244|NCT03679975|OG000|Outcome|Subjects With ALS|"Subjects with a diagnosis of probable or definite ALS in accordance with the Revised El-Escorial Criteria will be administered a single dose of the Riluzole Oral Soluble Film (ROSF) 50 mg.~Riluzole Oral Soluble film (ROSF) 50 mg: Enrolled subjects will undergo an instrumental evaluation of swallowing safety before and after administration of a single dose of the ROSF formulation containing 50 mg of riluzole."
11016331|NCT01134081|OG001|Outcome|Free Gingival Grafts|"Harvested tissue from palate~Free Gingival Graft: Harvested tissue from palate"
11016332|NCT01134081|EG000|Reported Event|CelTx™|Living bilayered cell therapy product
11016333|NCT01134081|EG001|Reported Event|Free Gingival Graft|Harvested tissue from palate
11016334|NCT01134107|BG000|Baseline|Lispro 6D/Aspart 6D|Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
11016335|NCT01134107|BG001|Baseline|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
11016336|NCT01134107|BG002|Baseline|Total|Total of all reporting groups
11016337|NCT01134107|FG000|Participant Flow|Lispro 6D/Aspart 6D|Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
11016338|NCT01134107|FG001|Participant Flow|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
11016339|NCT01134107|OG000|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
11016340|NCT01134107|OG001|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
11016341|NCT01134107|EG000|Reported Event|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
11016342|NCT01134107|EG001|Reported Event|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
11016343|NCT01134198|BG000|Baseline|Mifepristone|"demographics for 16 participants who were randomized and started Phase 1.~Mifepristone 600mg, 3x/wk for 4 weeks."
11016344|NCT01134198|BG001|Baseline|Placebo|"demographics for 13 participants who were randomized and started Phase 1.~Placebo 600mg, 3x/week for 4 weeks"
11016345|NCT01134198|BG002|Baseline|Total|Total of all reporting groups
11016346|NCT01134198|FG000|Participant Flow|Mifepristone|"Mifepristone 600mg~Mifepristone: Mifepristone 600mg, 3x/wk for 4 weeks"
11016347|NCT01134198|FG001|Participant Flow|Placebo|"Placebo~placebo: placebo"
11016348|NCT01134198|OG000|Outcome|Mifepristone|"Mifepristone 600mg~Mifepristone: Mifepristone 600mg, 3x/wk for 4 weeks"
11016349|NCT01134198|OG001|Outcome|Placebo|"Placebo~placebo: placebo"
11016350|NCT01134198|EG000|Reported Event|Mifepristone|"Mifepristone 600mg~Mifepristone: Mifepristone 600mg, 3x/wk for 4 weeks"
11016351|NCT01134198|EG001|Reported Event|Placebo|"Placebo~placebo: placebo"
11016352|NCT01134263|BG000|Baseline|CYD Dengue Vaccine Phase III Lot 1|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016353|NCT01134263|BG001|Baseline|CYD Dengue Vaccine Phase III Lot 2|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016354|NCT01134263|BG002|Baseline|CYD Dengue Vaccine Phase III Lot 3|Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016355|NCT01134263|BG003|Baseline|CYD Dengue Vaccine Phase II Lot|Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months, subcutaneously.
11016356|NCT01134263|BG004|Baseline|Placebo|Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016357|NCT01134263|BG005|Baseline|Total|Total of all reporting groups
11016358|NCT01134263|FG000|Participant Flow|CYD Dengue Vaccine Phase III Lot 1|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016359|NCT01134263|FG001|Participant Flow|CYD Dengue Vaccine Phase III Lot 2|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016360|NCT01134263|FG002|Participant Flow|CYD Dengue Vaccine Phase III Lot 3|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016361|NCT01134263|FG003|Participant Flow|CYD Dengue Vaccine Phase II Lot|Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016362|NCT01134263|FG004|Participant Flow|Placebo|Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016363|NCT01134263|OG000|Outcome|CYD Dengue Vaccine Phase III Lot 1|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016364|NCT01134263|OG001|Outcome|CYD Dengue Vaccine Phase III Lot 2|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3), subcutaneously.
11016365|NCT01134263|OG002|Outcome|CYD Dengue Vaccine Phase III Lot 3|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3) , subcutaneously.
11016366|NCT01134263|OG000|Outcome|CYD Dengue Vaccine Pooled Phase III Lot|Participants received 3 doses of CYD dengue vaccine one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3) from any of the Phase III Lots 1, 2 or 3.
11016367|NCT01134263|OG001|Outcome|CYD Dengue Vaccine Phase II Lot|Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016368|NCT01134263|OG000|Outcome|CYD Dengue Vaccine Phase III Lot 1|Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016369|NCT01134263|OG001|Outcome|CYD Dengue Vaccine Phase III Lot 2|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016370|NCT01134263|OG002|Outcome|CYD Dengue Vaccine Phase III Lot 3|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016371|NCT01134263|OG003|Outcome|CYD Dengue Vaccine Phase II Lot|Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016372|NCT01134263|OG004|Outcome|Placebo|Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016373|NCT01134263|OG003|Outcome|CYD Dengue Vaccine Phase II Lot|Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0(vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016374|NCT01134263|EG000|Reported Event|CYD Dengue Vaccine Phase III Lot 1|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016375|NCT01134263|EG001|Reported Event|CYD Dengue Vaccine Phase III Lot 2|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016376|NCT01134263|EG002|Reported Event|CYD Dengue Vaccine Phase III Lot 3|Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016377|NCT01134263|EG003|Reported Event|CYD Dengue Vaccine Phase II Lot|Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016378|NCT01134263|EG004|Reported Event|Placebo|Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
11016379|NCT01134276|BG000|Baseline|ERBD|final biliary drainage procedure: biliary drainage via ERBD/ENBD
11016380|NCT01134276|BG001|Baseline|PTBD|final biliary drainage procedure : biliary drainage via PTBD
10887299|NCT00499655|OG000|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
11016381|NCT01134276|BG002|Baseline|Total|Total of all reporting groups
11016382|NCT01134276|FG000|Participant Flow|ERBD|biliary drainage : biliary drainage via ERBD/ENBD
11016383|NCT01134276|FG001|Participant Flow|PTBD|biliary drainage : biliary drainage via PTBD
11016384|NCT01134276|OG000|Outcome|PTBD|finial biliary drainage procedure: biliary drainage via PTBD
11016385|NCT01134276|OG001|Outcome|ERBD|finial biliary drainage procedure: biliary drainage via ERBD or ENBD
11016386|NCT01134276|OG000|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
11016387|NCT01134276|OG001|Outcome|ENBD/ERBD|Final biliary drainage procedure: biliary drainage via ENBD/ERBD
11016388|NCT01134276|OG001|Outcome|ERBD|Final biliary drainage procedure: biliary drainage via ERBD/ENBD
11016389|NCT01134276|EG000|Reported Event|PTBD|"final biliary drainage procedure: biliary drainage via PTBD~Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
11016390|NCT01134276|EG001|Reported Event|ERBD|"final biliary drainage procedure: biliary drainage via ERBD/ENBD~Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
11016391|NCT01134315|BG000|Baseline|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
11016392|NCT01134315|BG001|Baseline|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
11016393|NCT01134315|BG002|Baseline|Total|Total of all reporting groups
11016394|NCT01134315|FG000|Participant Flow|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
11016395|NCT01134315|FG001|Participant Flow|Calcitriol|Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
11016396|NCT01134315|OG000|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
11016397|NCT01134315|OG001|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
11016398|NCT01134315|EG000|Reported Event|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
11016399|NCT01134315|EG001|Reported Event|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
11016400|NCT01134328|BG000|Baseline|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
11016401|NCT01134328|BG001|Baseline|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
11016402|NCT01134328|BG002|Baseline|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
11016403|NCT01134328|BG003|Baseline|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
11016404|NCT01134328|BG004|Baseline|Total|Total of all reporting groups
11016405|NCT01134328|FG000|Participant Flow|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
11016406|NCT01134328|FG001|Participant Flow|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
11016407|NCT01134328|FG002|Participant Flow|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
11016408|NCT01134328|FG003|Participant Flow|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
11016409|NCT01134328|OG000|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
11016410|NCT01134328|OG001|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
11016411|NCT01134328|OG002|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
11016412|NCT01134328|OG003|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
11016413|NCT01134328|EG000|Reported Event|AC-150 Combo|AC-150: 1 drop in each eye for up to 14 days
11016414|NCT01134328|EG001|Reported Event|AC-150A 0.1%|AC-150A: 1 drop in each eye once per day for up to 14 days
11016415|NCT01134328|EG002|Reported Event|AC-150B 0.005%|AC-150B: 1 drop in each eye once per day for up to 14 days
11016416|NCT01134328|EG003|Reported Event|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
11016417|NCT01134393|BG000|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11016418|NCT01134393|FG000|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11016419|NCT01134393|OG000|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11016420|NCT01134393|EG000|Reported Event|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11016421|NCT01134393|EG001|Reported Event|T80/A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily
11016422|NCT01134510|BG000|Baseline|C1 Esterase Inhibitor|"Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. The PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be emailed or faxed to the patient for review & consideration of study participation. The patient can contact the study team to ask questions and sign the Informed Consent Form (ICF), if interested.~C1 INH is dosed at 20 units per kg body weight and is administered by slow IV injection at a rate of approximately 4 mL per minute. Study patients will receive 20U/kg C1 INH vs placebo (0.9% NS) on days 0 and day 2, then twice weekly X 3 weeks."
11016423|NCT01134510|BG001|Baseline|Placebo|Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. Then PI will describe the standard of care of Transplant Immunology Program (TIP) patients. After that PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be either emailed or faxed to the patient for review and consideration of study participation. The patient can contact the study team where they will have the opportunity to ask questions and then sign the Informed Consent Form (ICF), if interested.
11016424|NCT01134510|BG002|Baseline|Total|Total of all reporting groups
11016425|NCT01134510|FG000|Participant Flow|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, Complement 3 and Complement 4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% Normal Saline) on day 0 and day 2, then twice weekly X 3 weeks. A protocol biopsy will be performed at 6 month to assess the allograft for evidence of Antibody Mediated Rejection, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and Anibody Mediated Rejection episodes as well as Donor Specific Antibody. A protocol biopsy will be performed at 6 month.
11016426|NCT01134510|FG001|Participant Flow|Placebo|Patients will receive placebo (0.9% Normal Saline) on days 0 and day 2, then twice weekly for 3 weeks.
11016427|NCT01134510|OG000|Outcome|C1 Esterase Inhibitor|"10 subjects will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
11016428|NCT01134510|OG001|Outcome|Normal Saline|"10 subjects placebo in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
11016429|NCT01134510|OG000|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
11016430|NCT01134510|OG001|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
11016431|NCT01134510|OG000|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
11016432|NCT01134510|EG000|Reported Event|Placebo|Total of 2 Serious Adverse Events (2/10 patients = 20%)
11016433|NCT01134510|EG001|Reported Event|C1 Esterase Inhibitor|Total of 1 Serious Adverse Event (1/10 = 10%)
11016434|NCT01129011|BG000|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
11016435|NCT01129011|BG001|Baseline|Naproxen|Naproxen 500 mg dosed twice daily (bid)
11016436|NCT01129011|BG002|Baseline|Total|Total of all reporting groups
11016437|NCT01129011|FG000|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
11016438|NCT01129011|FG001|Participant Flow|Naproxen|Naproxen 500 mg dosed twice daily (bid)
11016439|NCT01129011|OG000|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
11016440|NCT01129011|OG001|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
11016441|NCT01129011|EG000|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
11016442|NCT01129011|EG001|Reported Event|Naproxen|Naproxen 500 mg dosed twice daily (bid)
11016443|NCT01134549|BG000|Baseline|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
11016444|NCT01134549|BG001|Baseline|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
11016445|NCT01134549|BG002|Baseline|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
11016446|NCT01134549|BG003|Baseline|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
11016447|NCT01134549|BG004|Baseline|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
11016448|NCT01134549|BG005|Baseline|Total|Total of all reporting groups
11016449|NCT01134549|FG000|Participant Flow|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
11016450|NCT01134549|FG001|Participant Flow|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
11016451|NCT01134549|FG002|Participant Flow|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
11016452|NCT01134549|FG003|Participant Flow|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
11016453|NCT01134549|FG004|Participant Flow|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
11016454|NCT01134549|OG000|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
11016455|NCT01134549|OG001|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
11016456|NCT01134549|OG002|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
11016457|NCT01134549|OG003|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
11016458|NCT01134549|OG004|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
11016459|NCT01134549|OG000|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
11016460|NCT01134549|OG001|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
11016461|NCT01134549|OG002|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
11016462|NCT01134549|OG003|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
11016463|NCT01134549|EG000|Reported Event|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
11016464|NCT01134549|EG001|Reported Event|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
11016465|NCT01134549|EG002|Reported Event|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
11016466|NCT01134549|EG003|Reported Event|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
11016467|NCT01134549|EG004|Reported Event|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
11016468|NCT01134549|EG005|Reported Event|Etelcalcetide Pooled|Participants received a single dose of etelcalcetide administered by intravenous injection.
11016469|NCT01134562|BG000|Baseline|Cohort 1: Placebo/Etelcalcetide 5 mg|Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
11016470|NCT01134562|BG001|Baseline|Cohort 2: Placebo/Etelcalcetide 10 mg|Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
11016471|NCT01134562|BG002|Baseline|Cohort 3: Placebo/Etelcalcetide 20 mg|Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
11016472|NCT01134562|BG003|Baseline|Cohort 4: Placebo/Etelcalcetide 40 mg|Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design.
11016473|NCT01134562|BG004|Baseline|Cohort 5: Placebo/Etelcalcetide 60 mg|Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.
11016474|NCT01134562|BG005|Baseline|Total|Total of all reporting groups
11016475|NCT01134562|FG000|Participant Flow|Cohort 1: Placebo/Etelcalcetide 5 mg|Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
11016476|NCT01134562|FG001|Participant Flow|Cohort 2: Placebo/Etelcalcetide 10 mg|Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
11016477|NCT01134562|FG002|Participant Flow|Cohort 3: Placebo/Etelcalcetide 20 mg|Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
11016478|NCT01134562|FG003|Participant Flow|Cohort 4: Placebo/Etelcalcetide 40 mg|Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design.
11016479|NCT01134562|FG004|Participant Flow|Cohort 5: Placebo/Etelcalcetide 60 mg|Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.
11016480|NCT01134562|OG000|Outcome|Pooled Placebo|Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
11016481|NCT01134562|OG001|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
11016482|NCT01134562|OG002|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
11016483|NCT01134562|OG003|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
11016484|NCT01134562|OG004|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
11016485|NCT01134562|OG005|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
11016486|NCT01134562|OG000|Outcome|Pooled Placebo|Participants received a single dose of placebo IV injection after hemodialysis.
11016487|NCT01134562|OG000|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
11016488|NCT01134562|OG001|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
11016489|NCT01134562|OG002|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
11016490|NCT01134562|OG003|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
11016491|NCT01134562|OG004|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
11016492|NCT01134562|EG000|Reported Event|Pooled Placebo|Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
11016493|NCT01134562|EG001|Reported Event|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
11016494|NCT01134562|EG002|Reported Event|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
11016495|NCT01134562|EG003|Reported Event|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
11016496|NCT01134562|EG004|Reported Event|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
11016497|NCT01134562|EG005|Reported Event|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
11016498|NCT01134575|BG000|Baseline|Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2|"First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016499|NCT01134575|BG001|Baseline|Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2|"First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016500|NCT01134575|BG002|Baseline|Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)|"CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016501|NCT01134575|BG003|Baseline|Total|Total of all reporting groups
11016502|NCT01134575|FG000|Participant Flow|Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2|"First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11066158|NCT01390909|BG001|Baseline|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort.
11066159|NCT01390909|BG002|Baseline|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
11066160|NCT01390909|BG003|Baseline|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
11016503|NCT01134575|FG001|Participant Flow|Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2|"First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016504|NCT01134575|FG002|Participant Flow|Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)|"CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016505|NCT01134575|OG000|Outcome|Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2|"First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016506|NCT01134575|OG001|Outcome|Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2|"First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016507|NCT01134575|OG002|Outcome|Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)|"CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016508|NCT01134575|EG000|Reported Event|Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2|"First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016509|NCT01134575|EG001|Reported Event|Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2|"First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11066161|NCT01390909|BG004|Baseline|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (602 participants) were matched with participant records in the Medicaid, well-controlled cohort.
11016510|NCT01134575|EG002|Reported Event|Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)|"CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.~CMC-544 (Inotuzumab Ozogamycin): First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.~Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks."
11016511|NCT01134627|BG000|Baseline|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
11016512|NCT01134627|BG001|Baseline|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
11016513|NCT01134627|BG002|Baseline|Total|Total of all reporting groups
11016514|NCT01134627|FG000|Participant Flow|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
11016515|NCT01134627|FG001|Participant Flow|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
11016516|NCT01134627|OG000|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
11016517|NCT01134627|OG001|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
11148375|NCT01863680|BG000|Baseline|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro fertilization and embryo transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
11016518|NCT01134627|EG000|Reported Event|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
11016519|NCT01134627|EG001|Reported Event|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
11016520|NCT01134705|BG000|Baseline|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
11016521|NCT01134705|BG001|Baseline|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
11016522|NCT01134705|BG002|Baseline|Total|Total of all reporting groups
11016523|NCT01134705|FG000|Participant Flow|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily.
11016524|NCT01134705|FG001|Participant Flow|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
11016525|NCT01134705|OG000|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
11016526|NCT01134705|OG001|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
11016527|NCT01134705|EG000|Reported Event|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
11016528|NCT01134705|EG001|Reported Event|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
11016529|NCT01134731|BG000|Baseline|Paliperidone 1-5mg|daily
11016530|NCT01134731|BG001|Baseline|Lithium 600-1500mg|daily
11016531|NCT01134731|BG002|Baseline|Placebo 1-5 Capsules|12 weeks
11016532|NCT01134731|BG003|Baseline|Total|Total of all reporting groups
11016533|NCT01134731|FG000|Participant Flow|Paliperidone|dose escalation, levels 1-5 daily dosing range from 1-5 mg
11016534|NCT01134731|FG001|Participant Flow|Lithium|"mood stabilizer~dose escalation levels 1-5 daily dosing lithium: 300-1500mg daily (QD)"
11016535|NCT01134731|FG002|Participant Flow|Placebo|1-5 capsules
11016536|NCT01134731|OG000|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg~paliperidone: 1-5 mg qd"
11016537|NCT01134731|OG001|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg~lithium: 300-1500mg QD"
11016538|NCT01134731|OG002|Outcome|Placebo|placebo comparator, 1-5 capsules
11016539|NCT01134731|OG002|Outcome|Placebo|1-5 placebo capsules
11016540|NCT01134731|EG000|Reported Event|Paliperidone|
11016541|NCT01134731|EG001|Reported Event|Lithium|
11016542|NCT01134731|EG002|Reported Event|Placebo|
11016543|NCT01134783|BG000|Baseline|Control Group|This control group arm consists of students who served as the comparison group.
11016544|NCT01134783|BG001|Baseline|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
11016545|NCT01134783|BG002|Baseline|Total|Total of all reporting groups
11016546|NCT01134783|FG000|Participant Flow|Intervention Group|224 participants were randomized to the intervention condition
11016547|NCT01134783|FG001|Participant Flow|Control Group|217 participants were randomized to the control condition
11016548|NCT01134783|OG000|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
11016549|NCT01134783|OG001|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
11016550|NCT01134783|OG000|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
11016551|NCT01134783|OG001|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
11016552|NCT01134783|OG000|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
11016553|NCT01134783|OG001|Outcome|Control Group|Control group (serving as a comparison group)
11016554|NCT01134783|EG000|Reported Event|Intervention Group|This intervention group is a combination of the face-to-face class students, hybrid class students and online class students.
11016555|NCT01134783|EG001|Reported Event|Control Group|This control group consists of students who served as the comparison group.
11016556|NCT01134887|BG000|Baseline|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
11016557|NCT01134887|BG001|Baseline|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
11016558|NCT01134887|BG002|Baseline|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
11016559|NCT01134887|BG003|Baseline|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
11016560|NCT01134887|BG004|Baseline|Total|Total of all reporting groups
11016561|NCT01134887|FG000|Participant Flow|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
11016562|NCT01134887|FG001|Participant Flow|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
11016563|NCT01134887|FG002|Participant Flow|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
11016564|NCT01134887|FG003|Participant Flow|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
11016565|NCT01134887|OG000|Outcome|Arm 1: Intervention-Veterans|"Veterans randomized to the intervention group received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit, an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the Veteran in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
11016566|NCT01134887|OG001|Outcome|Arm 2: Control-Veterans|"The attention control comparator consisted of giving Veterans a copy of the NIA guide for Talking with Your Doctor. This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
11016567|NCT01134887|EG000|Reported Event|Arm 1: Intervention|"Veterans enrolled in the intervention arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
11016568|NCT01134887|EG001|Reported Event|Arm 2: Attention Control|"Veterans enrolled in the attention control arm received a copy of the NIA guide for Talking with Your Doctor. This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
11016569|NCT01134887|EG002|Reported Event|Arm 3: Intervention-Physicians|The 5 intervention arm physicians were coached in the Four Habits of Highly Effective Clinicians in a one hour face to face meeting involving review of the provider's interaction with his or her intervention patients and suggestions for improvement based on these observations.
11016570|NCT01134887|EG003|Reported Event|Arm 4: Control-Physicians|Control physicians were told to conduct their encounters as usual and were not given any coaching. Adverse event reporting was provided as part of the study.
11016571|NCT01134900|BG000|Baseline|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
11016572|NCT01134900|BG001|Baseline|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
11016573|NCT01134900|BG002|Baseline|Total|Total of all reporting groups
11016574|NCT01134900|FG000|Participant Flow|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
11016575|NCT01134900|FG001|Participant Flow|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
11016576|NCT01134900|OG000|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
11016577|NCT01134900|OG001|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
11016578|NCT01134900|EG000|Reported Event|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
11016579|NCT01134900|EG001|Reported Event|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
11016580|NCT01134939|BG000|Baseline|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
11016581|NCT01134939|BG001|Baseline|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
11016582|NCT01134939|BG002|Baseline|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
11016583|NCT01134939|BG003|Baseline|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
11016584|NCT01134939|BG004|Baseline|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
11016585|NCT01134939|BG005|Baseline|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
11016586|NCT01134939|BG006|Baseline|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
11016587|NCT01134939|BG007|Baseline|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
11016588|NCT01134939|BG008|Baseline|Total|Total of all reporting groups
11016589|NCT01134939|FG000|Participant Flow|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
11016590|NCT01134939|FG001|Participant Flow|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
11016591|NCT01134939|FG002|Participant Flow|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
11016592|NCT01134939|FG003|Participant Flow|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
11016593|NCT01134939|FG004|Participant Flow|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
11016594|NCT01134939|FG005|Participant Flow|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
11016595|NCT01134939|FG006|Participant Flow|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
11016596|NCT01134939|FG007|Participant Flow|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
11016597|NCT01134939|OG000|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
11016598|NCT01134939|OG001|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
11016599|NCT01134939|OG002|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
11016600|NCT01134939|OG003|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
11016601|NCT01134939|OG004|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
11016602|NCT01134939|OG005|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
11016603|NCT01134939|OG006|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
11016604|NCT01134939|OG007|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
11016605|NCT01134939|EG000|Reported Event|Treatment-naive Patients|Female and male patients who were not pretreated with HIV therapy.
11016606|NCT01134939|EG001|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Female and male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
11016607|NCT01134939|EG002|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Female and male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
11016608|NCT01134939|EG003|Reported Event|Patients With Baseline Viral Load Not Documented|Female and male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
11016609|NCT01134952|BG000|Baseline|MMF MRL Switch|Liver transplant recipients with Hepatitis C virus switched from mycophenolate mofetil (MMF) to sirolimus (SRL) for 3 months and then switched back to MMF
11016610|NCT01134952|FG000|Participant Flow|MMF SRL Switch|Liver transplant recipients with Hepatitis C virus taking sirolimus (SRL) instead of mycophenolate mofetil (MMF) for 3 months
11016611|NCT01134952|OG000|Outcome|MMF SRL Switch|Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
11016612|NCT01134952|OG000|Outcome|MMF SRL Switch|All patients switched for 3 months from mycophenolate mofetil to sirolimus and then back to mycophenolate mofetil
11016613|NCT01134952|OG000|Outcome|MMF SRL Switch|All patients after switch from mycophenolate to sirolimus
11016614|NCT01134952|OG000|Outcome|MMF SRL Switch|Liver transplant recipients switched from mycophenolate mofetil to sirolimus
11016615|NCT01134952|OG000|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
11016616|NCT01134952|EG000|Reported Event|MMF SRL Switch|All patients during 3 month period of switch from mycophenolate mofetil (MMF) to sirolimus and for 3 months after switch back to MMF
11016617|NCT01135017|BG000|Baseline|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
11016618|NCT01135017|BG001|Baseline|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
11016619|NCT01135017|BG002|Baseline|Total|Total of all reporting groups
11016620|NCT01135017|FG000|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
11016621|NCT01135017|FG001|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
11016622|NCT01135017|OG000|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
11016623|NCT01135017|OG001|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
11016624|NCT01135017|EG000|Reported Event|Placebo|Placebo (for dronedarone) twice a day for 12 weeks
11016625|NCT01135017|EG001|Reported Event|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
11016626|NCT01135069|BG000|Baseline|Generic|Tretinoin Microsphere Gel 0.1%
11016627|NCT01135069|BG001|Baseline|Brand|Retin-A Micro 0.1%
11016628|NCT01135069|BG002|Baseline|Placebo|Microsphere Gel no active
11016629|NCT01135069|BG003|Baseline|Total|Total of all reporting groups
11016630|NCT01135069|FG000|Participant Flow|Generic|Tretinoin Microsphere Gel 0.1%
11016631|NCT01135069|FG001|Participant Flow|Brand|Retin-A Micro 0.1%
11016632|NCT01135069|FG002|Participant Flow|Placebo|Microsphere Gel no active
11016633|NCT01135069|OG000|Outcome|Generic|"treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 74% reduction."
11016634|NCT01135069|OG001|Outcome|Brand|"Treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 76% reduction"
11016635|NCT01135069|OG002|Outcome|Placebo|"Treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 58% reduction"
11016636|NCT01135069|EG000|Reported Event|Generic|Tretinoin Microsphere Gel 0.1%
11016637|NCT01135069|EG001|Reported Event|Brand|Retin-A Micro 0.1%
11016638|NCT01135069|EG002|Reported Event|Placebo|Microsphere Gel no active
11016639|NCT01135095|BG000|Baseline|Low-dose Imaging|"Low-dose versus standard dose imaging~Low-dose imaging: the study is designed to assess the validity of a low dose (~5mSv) Tc99m one day protocol using D-SPECT standard protocol as the comparators.~D-SPECT cardiac scanner: the D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large photomultiplier tubes. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient."
11016640|NCT01135095|FG000|Participant Flow|Low-dose Imaging|"Low-dose versus standard-dose imaging~Low-dose imaging: the study is designed to assess the validity of a low-dose (~5mSv) Tc99m one day protocol using D-SPECT standard protocol as the comparators.~D-SPECT cardiac scanner: the D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large photomultiplier tubes. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient."
11066162|NCT01390909|BG005|Baseline|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
11066163|NCT01390909|BG006|Baseline|Total|Total of all reporting groups
11016641|NCT01135095|OG000|Outcome|Low-dose Imaging|"Low-dose versus standard dose imaging~Low-dose imaging: the study is designed to assess the validity of a low dose (~5mSv) Tc99m one day protocol using D-SPECT standard protocol as the comparators.~D-SPECT cardiac scanner: the D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large photomultiplier tubes. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient"
11016642|NCT01135095|EG000|Reported Event|Low-dose Imaging|"Low-dose versus standard dose imaging~Low-dose imaging: the study is designed to assess the validity of a low dose (~5mSv) Tc99m one day protocol using D-SPECT standard protocol as the comparators.~D-SPECT cardiac scanner: the D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large photomultiplier tubes. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient"
11016643|NCT01135186|BG000|Baseline|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1 through week 4)~sapropterin dihydrochloride: sapropterin dihydrochloride: 20mg/kg/day (week 5 through week 8)"
11016644|NCT01135186|FG000|Participant Flow|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day"
11016645|NCT01135186|OG000|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day"
11016646|NCT01135186|OG000|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day week 1-4, 20mg/kg/day week 5-8."
11016647|NCT01135186|OG000|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day weeks (1-4) and 20mg/kg/days weeks (week 5-8)"
11016648|NCT01135186|EG000|Reported Event|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1-4) 20 mg/kg/day (week 5-8)"
11016649|NCT01135329|BG000|Baseline|BMT Allogenic Transplantation|Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,: Fludarabine 30 mg/m2 IV once a day for 4 days Busulfan 0.8 mg/kg IV every 12 hours for 4 days Cyclophosphamide 50 mg/kg IV daily for 2 days
11016650|NCT01135329|FG000|Participant Flow|BMT Allogenic Transplantation|Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,: Fludarabine 30 mg/m2 IV once a day for 4 days Busulfan 0.8 mg/kg IV every 12 hours for 4 days Cyclophosphamide 50 mg/kg IV daily for 2 days
11016651|NCT01135329|OG000|Outcome|BMT Allogenic Transplantation|Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
11016652|NCT01135329|OG000|Outcome|Transplant|Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
11016653|NCT01135329|EG000|Reported Event|Transplant|Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
11066164|NCT01390909|FG000|Participant Flow|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
11066165|NCT01390909|FG001|Participant Flow|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
11066166|NCT01390909|FG002|Participant Flow|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
11066167|NCT01390909|FG003|Participant Flow|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
11066168|NCT01390909|FG004|Participant Flow|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
11066169|NCT01390909|FG005|Participant Flow|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
11066170|NCT01390909|OG000|Outcome|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
11066171|NCT01390909|OG001|Outcome|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
11066172|NCT01390909|OG002|Outcome|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
11066173|NCT01390909|OG003|Outcome|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
11066174|NCT01390909|OG004|Outcome|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
11016654|NCT01135368|BG000|Baseline|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
11016655|NCT01135368|FG000|Participant Flow|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
11016656|NCT01135368|OG000|Outcome|None|Participants with no symptoms at Baseline.
11016657|NCT01135368|OG001|Outcome|Mild|Participants with mild symptoms at Baseline.
11016658|NCT01135368|OG002|Outcome|Moderate|Participants with moderate symptoms at Baseline.
11016659|NCT01135368|OG003|Outcome|Severe|Participants with severe symptoms at Baseline.
11016660|NCT01135368|OG000|Outcome|Grade 0|Participants with Grade 0 (normal aspect of mucosa) at Baseline.
11016661|NCT01135368|OG001|Outcome|Grade A|Participants with Grade A (one or more mucosal breaks no longer than 5 mm, none of which extends between the tops of the mucosal folds) at Baseline.
11016662|NCT01135368|OG002|Outcome|Grade B|Participants with Grade B (one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds) at Baseline.
11016663|NCT01135368|OG003|Outcome|Grade C|Participants with Grade C (mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75% of the oesophageal circumference) at Baseline.
11016664|NCT01135368|OG004|Outcome|Grade D|Participants with Grade D (mucosal breaks which involve at least 75% of the oesophageal circumference) at Baseline.
11016665|NCT01135368|OG000|Outcome|Normal|Participants with normal ECL cell classification at Baseline.
11016666|NCT01135368|OG001|Outcome|Simple|Participants with simple (diffuse) hyperplasia at Baseline.
11016667|NCT01135368|OG002|Outcome|Linear|Participants with linear, chain producing hyperplasia at Baseline.
11016668|NCT01135368|OG003|Outcome|No Data|Participants with no data at Baseline.
11016669|NCT01135368|OG000|Outcome|No Atrophy|Participants with no atrophy at Baseline.
11016670|NCT01135368|OG001|Outcome|Mild|Participants with mild atrophy at Baseline.
11016671|NCT01135368|OG002|Outcome|Moderate|Participants with moderate atrophy at Baseline.
11016672|NCT01135368|OG003|Outcome|Severe|Participants with severe atrophy at Baseline.
11016673|NCT01135368|OG004|Outcome|No Data|Participants with no data at Baseline.
11016674|NCT01135368|OG000|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
11016675|NCT01135368|OG000|Outcome|None|Participants with no intestinal metaplasia at Baseline.
11016676|NCT01135368|OG001|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
11016677|NCT01135368|OG002|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
11016678|NCT01135368|OG003|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
11016679|NCT01135368|OG004|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
11016680|NCT01135368|OG000|Outcome|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
11016681|NCT01135368|OG000|Outcome|Missing Data|Participants with no data at Baseline.
11016682|NCT01135368|OG001|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
11016683|NCT01135368|OG002|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
11016684|NCT01135368|OG003|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
11016685|NCT01135368|OG000|Outcome|No Data|Participants with no color vision data at Baseline.
11016686|NCT01135368|OG001|Outcome|Normal|Participants with normal color vision at Baseline.
11016687|NCT01135368|OG002|Outcome|Pathological|Participants with pathological color vision at Baseline.
11016688|NCT01135368|OG000|Outcome|No Data|Participants with no data at Baseline.
11016689|NCT01135368|OG001|Outcome|Normal|Participants with normal assessment at Baseline.
11016690|NCT01135368|OG002|Outcome|Pathological|Participants with pathological assessment at Baseline.
11016691|NCT01135368|EG000|Reported Event|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
11016692|NCT01135381|BG000|Baseline|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
11016693|NCT01135381|BG001|Baseline|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
11016694|NCT01135381|BG002|Baseline|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
11016695|NCT01135381|BG003|Baseline|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
11016696|NCT01135381|BG004|Baseline|Total|Total of all reporting groups
11066175|NCT01390909|OG005|Outcome|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
11016697|NCT01135381|FG000|Participant Flow|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
11016698|NCT01135381|FG001|Participant Flow|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
11016699|NCT01135381|FG002|Participant Flow|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
11016700|NCT01135381|FG003|Participant Flow|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
11016701|NCT01135381|OG000|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
11016702|NCT01135381|OG001|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
11016703|NCT01135381|OG002|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
11016704|NCT01135381|OG003|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
11016705|NCT01135381|EG000|Reported Event|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
11016706|NCT01135381|EG001|Reported Event|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
11016707|NCT01135381|EG002|Reported Event|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
11016708|NCT01135381|EG003|Reported Event|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
11016709|NCT01135394|BG000|Baseline|Pioglitazone (Actos)|"Participants will have metabolism studies to consist of outpatient X-ray and MR measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.~Pioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks."
11016710|NCT01135394|FG000|Participant Flow|Pioglitazone (Actos)|"Participants will have metabolism studies to consist of outpatient X-ray and magnetic resonance (MR) measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.~Pioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks."
11016711|NCT01135394|OG000|Outcome|Pioglitazone (Actos)|"The study is a one-arm design.~All participants will receive Pioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks."
11066176|NCT01390909|OG006|Outcome|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
11066177|NCT01390909|OG007|Outcome|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
11016712|NCT01135394|EG000|Reported Event|Pioglitazone (Actos)|"Participants will have metabolism studies to consist of outpatient X-ray and MR measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.~Pioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks."
11016713|NCT01135420|BG000|Baseline|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
11016714|NCT01135420|BG001|Baseline|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety"
11016715|NCT01135420|BG002|Baseline|Total|Total of all reporting groups
11016716|NCT01135420|FG000|Participant Flow|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial received usual care (i.e., the care they would have received in the absence of a study)."
11016717|NCT01135420|FG001|Participant Flow|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention incorporated motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition received an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention had a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition was to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
11016718|NCT01135420|OG000|Outcome|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
11016719|NCT01135420|OG001|Outcome|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
11016720|NCT01135420|EG000|Reported Event|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
11148376|NCT01863680|FG000|Participant Flow|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using Gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
11016721|NCT01135420|EG001|Reported Event|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
11016722|NCT01135498|BG000|Baseline|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
11016723|NCT01135498|FG000|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2, tablet, orally (PO), every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
11016724|NCT01135498|OG000|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
11016725|NCT01135498|OG000|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"ACycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
11016726|NCT01135498|EG000|Reported Event|Bevacizumab+Eloxatin+Capecitabine/Bevacizumab+Erlotinib|A cycle was defined as the following: participants received 7.5 mg/kg bevacizumab, IV on Day 1; 130 mg/m^2 eloxatin tablets, orally, on Days 1 through 14; and 1000 mg/m^2 capecitabine tablets, orally, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. If all 6 cycles were tolerated with no disease progression, participants then received 7.5 mg/kg bevacizumab, IV on Day 1 and 150 mg erlotinib tablets, orally, once daily. This cycle was repeated every 3 weeks until disease progression.
11016727|NCT01135511|BG000|Baseline|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016728|NCT01135511|BG001|Baseline|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016729|NCT01135511|BG002|Baseline|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016730|NCT01135511|BG003|Baseline|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016731|NCT01135511|BG004|Baseline|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
11016732|NCT01135511|BG005|Baseline|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016733|NCT01135511|BG006|Baseline|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016734|NCT01135511|BG007|Baseline|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11225667|NCT02369900|FG000|Participant Flow|Esmolol Infusion|"Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.~Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs~Esmolol"
11016735|NCT01135511|BG008|Baseline|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016736|NCT01135511|BG009|Baseline|Total|Total of all reporting groups
11016737|NCT01135511|FG000|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016738|NCT01135511|FG001|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016739|NCT01135511|FG002|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016740|NCT01135511|FG003|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016741|NCT01135511|FG004|Participant Flow|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
11016742|NCT01135511|FG005|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016743|NCT01135511|FG006|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016744|NCT01135511|FG007|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
10886218|NCT00492752|FG001|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|"Participants randomized to Sorafenib treatment from until unblinding (August 19, 2007) until end of trial (July 27, 2009), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
11016745|NCT01135511|FG008|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016746|NCT01135511|OG000|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016747|NCT01135511|OG001|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016748|NCT01135511|OG002|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016749|NCT01135511|OG003|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016750|NCT01135511|OG004|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
11016751|NCT01135511|OG005|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016752|NCT01135511|OG006|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016753|NCT01135511|OG007|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11225668|NCT02369900|FG001|Participant Flow|Standard Care, Saline|"Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs~Saline"
11016754|NCT01135511|OG008|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016755|NCT01135511|EG000|Reported Event|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016756|NCT01135511|EG001|Reported Event|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016757|NCT01135511|EG002|Reported Event|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016758|NCT01135511|EG003|Reported Event|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016759|NCT01135511|EG004|Reported Event|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
11341245|NCT03679975|EG000|Reported Event|Subjects With ALS|"Subjects with a diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria will be administered a single dose of the Riluzole Oral Soluble Film (ROSF) 50 mg.~Riluzole Oral Soluble film (ROSF) 50 mg: Enrolled subjects will undergo an instrumental evaluation of swallowing safety before and after administration of a single dose of the ROSF formulation containing 50 mg of riluzole."
10886219|NCT00492752|FG002|Participant Flow|B1) Placebo - no Open Label Phase|"Participants randomized to Sorafenib-matching Placebo until unblinding (August 19, 2007), Placebo tablets matching in appearance were orally administered twice daily (bid).~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 2."
11016760|NCT01135511|EG005|Reported Event|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016761|NCT01135511|EG006|Reported Event|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016762|NCT01135511|EG007|Reported Event|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016763|NCT01135511|EG008|Reported Event|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
11016764|NCT01135524|BG000|Baseline|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
11016765|NCT01135524|FG000|Participant Flow|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
11016766|NCT01135524|OG000|Outcome|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
11016767|NCT01135524|EG000|Reported Event|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
11016768|NCT01135537|BG000|Baseline|Thymoglobulin|"Thymoglobulin 7.5 mg/kg/course prior to HSCT~Thymoglobulin (rATG): Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.~Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy."
11016769|NCT01135537|FG000|Participant Flow|Thymoglobulin|"Thymoglobulin 7.5 mg/kg/course prior to HSCT~Thymoglobulin (rATG): Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.~Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy."
11016770|NCT01135537|OG000|Outcome|Thymoglobulin|"Thymoglobulin 7.5 mg/kg/course prior to HSCT~Thymoglobulin (rATG): Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.~Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy."
11016771|NCT01135537|EG000|Reported Event|Thymoglobulin|"Thymoglobulin 7.5 mg/kg/course prior to HSCT~Thymoglobulin (rATG): Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.~Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy."
11016772|NCT01135914|BG000|Baseline|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
11016773|NCT01135914|BG001|Baseline|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
11016774|NCT01135914|BG002|Baseline|Laser Monotherapy|Participants received Laser photocoagulation therapy only
11016775|NCT01135914|BG003|Baseline|Total|Total of all reporting groups
11016776|NCT01135914|FG000|Participant Flow|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
11016777|NCT01135914|FG001|Participant Flow|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
11016778|NCT01135914|FG002|Participant Flow|Laser Monotherapy|Participants received Laser photocoagulation therapy only
11016779|NCT01135914|OG000|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
11016780|NCT01135914|OG001|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
11016781|NCT01135914|OG002|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
11016782|NCT01135914|EG000|Reported Event|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
11016783|NCT01135914|EG001|Reported Event|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
11016784|NCT01135914|EG002|Reported Event|Laser Monotherapy|Participants received Laser photocoagulation therapy only
11016785|NCT01135992|BG000|Baseline|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
11016786|NCT01135992|FG000|Participant Flow|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
11016787|NCT01135992|OG000|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
11016788|NCT01135992|EG000|Reported Event|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
11016789|NCT01136174|BG000|Baseline|Placebo|Placebo oral administration twice a day
11016790|NCT01136174|BG001|Baseline|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
11016791|NCT01136174|BG002|Baseline|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
11016792|NCT01136174|BG003|Baseline|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
11016793|NCT01136174|BG004|Baseline|Total|Total of all reporting groups
11016794|NCT01136174|FG000|Participant Flow|Placebo|Placebo oral administration twice a day
11016795|NCT01136174|FG001|Participant Flow|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
11016796|NCT01136174|FG002|Participant Flow|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
11016797|NCT01136174|FG003|Participant Flow|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
11016798|NCT01136174|OG000|Outcome|Placebo|Placebo oral administration twice a day
11016799|NCT01136174|OG001|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
11016800|NCT01136174|OG002|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
11016801|NCT01136174|OG003|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
11016802|NCT01136174|OG000|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
11016803|NCT01136174|OG001|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
11016804|NCT01136174|OG002|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
11016805|NCT01136174|OG000|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
11016806|NCT01136174|OG001|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
11016807|NCT01136174|OG002|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
11016808|NCT01136174|OG003|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
11016809|NCT01136174|OG000|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
11016810|NCT01136174|OG001|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
11016811|NCT01136174|EG000|Reported Event|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
11016812|NCT01136174|EG001|Reported Event|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
11016813|NCT01136174|EG002|Reported Event|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
11016814|NCT01136174|EG003|Reported Event|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
11016815|NCT01136226|BG000|Baseline|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
11016816|NCT01136226|FG000|Participant Flow|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
11016817|NCT01136226|OG000|Outcome|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
11016818|NCT01136226|OG000|Outcome|Eligard (TM)|"Eligard (TM) administered 22.5mg~Eligard (TM): Eligard (TM) 22.5 mg administered at baseline and Month 3"
11016819|NCT01136226|EG000|Reported Event|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
11016820|NCT01136291|BG000|Baseline|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
11016821|NCT01136291|BG001|Baseline|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
11016822|NCT01136291|BG002|Baseline|Total|Total of all reporting groups
11016823|NCT01136291|FG000|Participant Flow|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
11016824|NCT01136291|FG001|Participant Flow|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
11016825|NCT01136291|OG000|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
11016826|NCT01136291|OG001|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
11016827|NCT01136291|EG000|Reported Event|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
11016828|NCT01136291|EG001|Reported Event|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
11016829|NCT01136356|BG000|Baseline|Within Subjects Design|Participants received both study drugs (buprenorphine and morphine) in a randomized sequence.
11016830|NCT01136356|FG000|Participant Flow|Morphine First, Then Buprenorphine|Participants randomized to receive morphine (120 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using buprenorphine (32 mg/day i.m.) with the same time course
11016831|NCT01136356|FG001|Participant Flow|Buprenorphine First, Then Morphine|Participants randomized to receive buprenorphine (32 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using morphine (120 mg/day i.m.) with the same time course
11016832|NCT01136356|OG000|Outcome|Morphine|
11016833|NCT01136356|OG001|Outcome|Buprenorphine|
11016834|NCT01136356|EG000|Reported Event|All Participants|The adverse events were not specified per drug intervention, therefore, the adverse events per interventions is unknown. The data below references the adverse events recorded by licensed nursing personnel during the participants' 59-day protocol in a residential research unit. All participants (N=7) were randomized to receive either buprenorphine (32 mg/day i.m.) or morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day, or 30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received the second opioid administration and spontaneous withdrawal period using the same time course described above.
11016835|NCT01136382|BG000|Baseline|Placebo|Placebo pMDI bid
11016836|NCT01136382|BG001|Baseline|Budesonide|Budesonide pMDI 160 mcg bid
11016837|NCT01136382|BG002|Baseline|Total|Total of all reporting groups
11016838|NCT01136382|FG000|Participant Flow|Placebo|Placebo pMDI bid
11016839|NCT01136382|FG001|Participant Flow|Budesonide|Budesonide pMDI 160 mcg bid
11016840|NCT01136382|OG000|Outcome|Placebo|Placebo pMDI bid
11016841|NCT01136382|OG001|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
11016842|NCT01136382|EG000|Reported Event|Budesonide pMDI 160mcg b.i.d.|
11016843|NCT01136382|EG001|Reported Event|Placebo pMDI b.i.d.|
11016844|NCT01136408|BG000|Baseline|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
11016845|NCT01136408|BG001|Baseline|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
11016846|NCT01136408|BG002|Baseline|Warfarin|Dose-adjusted warfarin based on target INR values
11016847|NCT01136408|BG003|Baseline|Total|Total of all reporting groups
11016848|NCT01136408|FG000|Participant Flow|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
11016849|NCT01136408|FG001|Participant Flow|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
11016850|NCT01136408|FG002|Participant Flow|Warfarin|Dose-adjusted warfarin based on target INR values
11016851|NCT01136408|OG000|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
11016852|NCT01136408|OG001|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
11016853|NCT01136408|OG002|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
11016854|NCT01136408|OG002|Outcome|Warfarin|
11016855|NCT01136408|OG000|Outcome|Dabigatran Etexilate 220 mg Daily|"Dabigatran etexilate 110 mg capsule, twice a day, oral administration~Dabigatran etexilate: Dabigatran etexilate 110 mg capsule, twice a day, oral administration"
11016856|NCT01136408|OG001|Outcome|Dabigatran Etexilate 300 mg Daily|"Dabigatran etexilate 150 mg capsule, twice a day, oral administration~Dabigatran etexilate: Dabigatran etexilate 150 mg capsule, twice a day, oral administration"
11016857|NCT01136408|OG002|Outcome|Warfarin|"Dose-adjusted warfarin based on target INR values~Warfarin: Dose-adjusted warfarin based on target INR values"
11016858|NCT01136408|EG000|Reported Event|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
11016859|NCT01136408|EG001|Reported Event|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
11016860|NCT01136408|EG002|Reported Event|Warfarin|Dose-adjusted warfarin based on target INR values
11016861|NCT01136486|BG000|Baseline|Level of Severity of TBI|Four categories based on pain severity (no pain, mild, moderate and severe pain).
11016862|NCT01136486|FG000|Participant Flow|Treatment Arm|Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.
11016863|NCT01136486|OG000|Outcome|Severity of Pain by Severity of Injury|
11016864|NCT01136486|EG000|Reported Event|Severity of Pain by Severity of Injury|
11016865|NCT01136655|BG000|Baseline|Randomized Patients|All randomized patients
11016866|NCT01136655|FG000|Participant Flow|Randomized Patients|All randomized patients
11016867|NCT01136655|OG000|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
11016868|NCT01136655|OG001|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
11016869|NCT01136655|OG002|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
11016870|NCT01136655|OG003|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
11016871|NCT01136655|OG004|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
11016872|NCT01136655|OG003|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
11016873|NCT01136655|EG000|Reported Event|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
11016874|NCT01136655|EG001|Reported Event|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
11016875|NCT01136655|EG002|Reported Event|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
11016876|NCT01136655|EG003|Reported Event|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
11016877|NCT01136655|EG004|Reported Event|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
11016878|NCT01136733|BG000|Baseline|Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.~If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped."
11016879|NCT01136733|BG001|Baseline|Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11016880|NCT01136733|BG002|Baseline|Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11016881|NCT01136733|BG003|Baseline|Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus|The DLT was achieved and no participants were enrolled into this cohort.
11016882|NCT01136733|BG004|Baseline|Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus|Oral lenvatinib (18 mg) and everolimus (5 mg) was once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
11016883|NCT01136733|BG005|Baseline|Phase 2 (Arm B): 24 mg Lenvatinib|Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
11341246|NCT03680105|BG000|Baseline|Part 1; Cohort 1; RJX or Placebo|Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
11016884|NCT01136733|BG006|Baseline|Phase 2 (Arm C): 10 mg Everolimus|Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.
11016885|NCT01136733|BG007|Baseline|Total|Total of all reporting groups
11016886|NCT01136733|FG000|Participant Flow|Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.~If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped."
11016887|NCT01136733|FG001|Participant Flow|Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11016888|NCT01136733|FG002|Participant Flow|Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11016889|NCT01136733|FG003|Participant Flow|Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus|The DLT was achieved and no participants were enrolled into this cohort.
11016890|NCT01136733|FG004|Participant Flow|Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus|Oral lenvatinib (18mg) and everolimus (5 mg) was once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
11016891|NCT01136733|FG005|Participant Flow|Phase 2 (Arm B): 24 mg Lenvatinib|Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
11016892|NCT01136733|FG006|Participant Flow|Phase 2 (Arm C): 10 mg Everolimus|Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.
11016893|NCT01136733|OG000|Outcome|Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.~If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped."
11016894|NCT01136733|OG001|Outcome|Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11341247|NCT03680105|BG001|Baseline|Part 1; Cohort 2; RJX or Placebo|Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX or matching placebo on Day 1.
11341248|NCT03680105|BG002|Baseline|Part 1; Cohort 3; RJX or Placebo|Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX or matching placebo on Day 1.
11016895|NCT01136733|OG002|Outcome|Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11016896|NCT01136733|OG003|Outcome|Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus|The DLT was achieved and no participants were enrolled into this cohort.
11016897|NCT01136733|OG004|Outcome|Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus|Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
11016898|NCT01136733|OG005|Outcome|Phase 2 (Arm B): 24 mg Lenvatinib|Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
11016899|NCT01136733|OG006|Outcome|Phase 2 (Arm C): 10 mg Everolimus|Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.
11016900|NCT01136733|OG000|Outcome|Phase 1b: Dose Escalation and MTD Expansion Cohorts|Oral everolimus (18 mg) and lenvatinib (5 mg) were taken once daily in the morning (consistently with or without food) with water. Any dietary habits around the time of study medication intake had to be kept as consistent as possible throughout the study.
11016901|NCT01136733|OG002|Outcome|Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11016902|NCT01136733|OG000|Outcome|Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day withwater, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.~If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped."
11016903|NCT01136733|OG006|Outcome|Phase 2 (Arm C): 10 mg Everolimus|Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4 week) cycles.
11016904|NCT01136733|OG000|Outcome|Cycle 1, Day 1 (0 Hours)|Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
11016905|NCT01136733|OG001|Outcome|Cycle 1, Day 1 (2-8 Hours)|Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
11016906|NCT01136733|OG002|Outcome|Cycle 2, Day 1 (0 Hours)|Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
11016907|NCT01136733|OG003|Outcome|Cycle 2, Day 1 (2-8 Hours)|Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
11016908|NCT01136733|OG004|Outcome|Cycle 3, Day 1 (0 Hours)|Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
11016909|NCT01136733|OG005|Outcome|Cycle 3, Day 1 (2-8 Hours)|Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
11016910|NCT01136733|OG000|Outcome|Phase 2: 18 mg Lenvatinib + 5 mg Everolimus|Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
11016911|NCT01136733|OG001|Outcome|Phase 2: 24 mg Lenvatinib|Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
11016912|NCT01136733|OG000|Outcome|Phase 2: 18 mg Lenvatinib + 5 mg Everolimus|Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
11016913|NCT01136733|OG001|Outcome|Phase 2: 10 mg Everolimus|Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.
11016914|NCT01136733|EG000|Reported Event|Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.~If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped."
11016915|NCT01136733|EG001|Reported Event|Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11016916|NCT01136733|EG002|Reported Event|Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus|"Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.~If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort."
11016917|NCT01136733|EG003|Reported Event|Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus|The DLT was achieved and no participants were enrolled into this cohort.
11016918|NCT01136733|EG004|Reported Event|Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus|Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
11016919|NCT01136733|EG005|Reported Event|Phase 2 (Arm B): 24 mg Lenvatinib|Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
11016920|NCT01136733|EG006|Reported Event|Phase 2 (Arm C): 10 mg Everolimus|Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4 week) cycles.
11016921|NCT01136746|BG000|Baseline|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
11016922|NCT01136746|BG001|Baseline|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
11016923|NCT01136746|BG002|Baseline|Total|Total of all reporting groups
11016924|NCT01136746|FG000|Participant Flow|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
11016925|NCT01136746|FG001|Participant Flow|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
11016926|NCT01136746|OG000|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
11016927|NCT01136746|OG001|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
11016928|NCT01136746|EG000|Reported Event|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
11016929|NCT01136746|EG001|Reported Event|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
11016930|NCT01136772|BG000|Baseline|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
11016931|NCT01136772|BG001|Baseline|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
11016932|NCT01136772|BG002|Baseline|Total|Total of all reporting groups
11016933|NCT01136772|FG000|Participant Flow|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
11016934|NCT01136772|FG001|Participant Flow|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
11016935|NCT01136772|OG000|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
11016936|NCT01136772|OG001|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
11016937|NCT01136772|EG000|Reported Event|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
11016938|NCT01136772|EG001|Reported Event|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
11016939|NCT01136785|BG000|Baseline|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
11016940|NCT01136785|BG001|Baseline|Sham CPAP|7 days of sham CPAP in the laboratory.
11016941|NCT01136785|BG002|Baseline|Total|Total of all reporting groups
11016942|NCT01136785|FG000|Participant Flow|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
11016943|NCT01136785|FG001|Participant Flow|Sham CPAP|7 days of sham CPAP in the laboratory.
11016944|NCT01136785|OG000|Outcome|Active CPAP|7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea
10849715|NCT00297648|BG000|Baseline|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
11016945|NCT01136785|OG001|Outcome|Sham CPAP|7 days of sham CPAP in the laboratory.
11016946|NCT01136785|OG000|Outcome|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
11016947|NCT01136785|OG001|Outcome|CPAP|7 days of sham CPAP in the laboratory.
11016948|NCT01136785|OG000|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 12 participants who had complete 24-h profiles of glucose, insulin and counter-regulatory hormones before and after treatment with active CPAP.
11016949|NCT01136785|OG000|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 8 participants who had complete 24-h profiles of plasma norepinephrine before and after treatment with active CPAP.
11016950|NCT01136785|EG000|Reported Event|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
11016951|NCT01136785|EG001|Reported Event|Sham CPAP|7 days of sham CPAP in the laboratory.
11016952|NCT01136798|BG000|Baseline|Usual T2 DM Med Regimen|"Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.~Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks"
11016953|NCT01136798|BG001|Baseline|Usual T2 DM Med Regimen Plus Exenatide|"Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.~Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks"
11016954|NCT01136798|BG002|Baseline|Total|Total of all reporting groups
11016955|NCT01136798|FG000|Participant Flow|Usual T2 DM Med Regimen|"Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.~Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks"
11016956|NCT01136798|FG001|Participant Flow|Usual T2 DM Med Regimen Plus Exenatide|"Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.~Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks"
11341249|NCT03680105|BG003|Baseline|Part 1; Cohort 4; RJX or Placebo|Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX or matching placebo on Day 1.
11016957|NCT01136798|OG000|Outcome|Usual T2 DM Med Regimen|"Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.~Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks"
11016958|NCT01136798|OG001|Outcome|Usual T2 DM Med Regimen Plus Exenatide|"Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.~Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks"
11016959|NCT01136798|EG000|Reported Event|Usual T2 DM Med Regimen|"Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.~Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks"
11016960|NCT01136798|EG001|Reported Event|Usual T2 DM Med Regimen Plus Exenatide|"Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.~Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks"
11016961|NCT01136876|BG000|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
11016962|NCT01136876|BG001|Baseline|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
11016963|NCT01136876|BG002|Baseline|Total|Total of all reporting groups
11016964|NCT01136876|FG000|Participant Flow|Iodixanol 320|Iodixanol 320, a non-ionic iso-osmolar iodinated contrast media comparator, was administered as a single 652 mg dose for percutaneous coronary intervention procedure
11016965|NCT01136876|FG001|Participant Flow|Iopamidol 370|Iopamidol 370, a non-ionic low-osmolar iodinated contrast media, was administered as a single 755 mg dose for percutaneous coronary intervention procedure
11016966|NCT01136876|OG000|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
11016967|NCT01136876|OG001|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320
11016968|NCT01136876|OG002|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
11016969|NCT01136876|OG003|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
11016970|NCT01136876|EG000|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
11016971|NCT01136876|EG001|Reported Event|Iopamidol 370|Iopamidol 370 Non-ionic low osmolar iodinated contrast media: single administration for percutaneous coronary intervention
11016972|NCT01136915|BG000|Baseline|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
11016973|NCT01136915|BG001|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
11016974|NCT01136915|BG002|Baseline|Total|Total of all reporting groups
11016975|NCT01136915|FG000|Participant Flow|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
11016976|NCT01136915|FG001|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
11016977|NCT01136915|OG000|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
11016978|NCT01136915|OG001|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
11016979|NCT01136915|OG002|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
11016980|NCT01136915|OG003|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iodixanol 320
11016981|NCT01136915|EG000|Reported Event|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
11016982|NCT01136915|EG001|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
11016983|NCT01136954|BG000|Baseline|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
11341250|NCT03680105|BG004|Baseline|Part 1; Cohort 5; RJX or Placebo|Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX or matching placebo on Day 1.
10849716|NCT00297648|FG000|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
11016984|NCT01136954|BG001|Baseline|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
11016985|NCT01136954|BG002|Baseline|Total|Total of all reporting groups
11016986|NCT01136954|FG000|Participant Flow|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
11016987|NCT01136954|FG001|Participant Flow|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
11016988|NCT01136954|OG000|Outcome|Zonisamide (Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
11016989|NCT01136954|OG001|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
11016990|NCT01136954|OG000|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
11016991|NCT01136954|EG000|Reported Event|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
11016992|NCT01136954|EG001|Reported Event|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
11016993|NCT01137006|BG000|Baseline|Cohort 1A (5 mg/kg, q2w)|IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
11016994|NCT01137006|BG001|Baseline|Cohort 2A (10 mg/kg, q2w)|IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11016995|NCT01137006|BG002|Baseline|Cohort 3A (20 mg/kg, q2w)|IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11016996|NCT01137006|BG003|Baseline|Cohort 4A (30 mg/kg, q2w)|IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11016997|NCT01137006|BG004|Baseline|Cohort 1B (10 mg/kg, q3w)|IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11016998|NCT01137006|BG005|Baseline|Cohort 2B (20 mg/kg, q3w)|IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11016999|NCT01137006|BG006|Baseline|Cohort 3B (30 mg/kg, q3w)|IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017000|NCT01137006|BG007|Baseline|Total|Total of all reporting groups
11017001|NCT01137006|FG000|Participant Flow|Cohort 1A (5 mg/kg, q2w)|IMC-20D7S: 5 milligrams per kilogram (mg/kg) IMC-20D7S administered intravenously (i.v.) as an infusion every other week (q2w) on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
11017002|NCT01137006|FG001|Participant Flow|Cohort 2A (10 mg/kg, q2w)|IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017003|NCT01137006|FG002|Participant Flow|Cohort 3A (20 mg/kg, q2w)|IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017004|NCT01137006|FG003|Participant Flow|Cohort 4A (30 mg/kg, q2w)|IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017005|NCT01137006|FG004|Participant Flow|Cohort 1B (10 mg/kg, q3w)|IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion every three weeks (q3w) on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017006|NCT01137006|FG005|Participant Flow|Cohort 2B (20 mg/kg, q3w)|IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017007|NCT01137006|FG006|Participant Flow|Cohort 3B (30 mg/kg, q3w)|IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017008|NCT01137006|OG000|Outcome|IMC-20D7S|"IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle.~Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11017009|NCT01137006|OG000|Outcome|Cohort 1A (5 mg/kg, q2w)|IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
11017010|NCT01137006|OG001|Outcome|Cohort 2A (10 mg/kg, q2w)|IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017011|NCT01137006|OG002|Outcome|Cohort 3A (20 mg/kg, q2w)|IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017012|NCT01137006|OG003|Outcome|Cohort 4A (30 mg/kg, q2w)|IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017013|NCT01137006|OG004|Outcome|Cohort 1B (10 mg/kg, q3w)|IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017014|NCT01137006|OG005|Outcome|Cohort 2B (20 mg/kg, q3w)|IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017015|NCT01137006|OG006|Outcome|Cohort 3B (30 mg/kg, q3w)|IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017016|NCT01137006|EG000|Reported Event|Cohort 1A (5 mg/kg, q2w)|IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
11017017|NCT01137006|EG001|Reported Event|Cohort 2A (10 mg/kg, q2w)|IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017018|NCT01137006|EG002|Reported Event|Cohort 3A (20 mg/kg, q2w)|IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017019|NCT01137006|EG003|Reported Event|Cohort 4A (30 mg/kg, q2w)|IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017020|NCT01137006|EG004|Reported Event|Cohort 1B (10 mg/kg, q3w)|IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017021|NCT01137006|EG005|Reported Event|Cohort 2B (20 mg/kg, q3w)|IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017022|NCT01137006|EG006|Reported Event|Cohort 3B (30 mg/kg, q3w)|IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11017023|NCT01137032|BG000|Baseline|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
11017024|NCT01137032|FG000|Participant Flow|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
11017025|NCT01137032|OG000|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
11017026|NCT01137032|EG000|Reported Event|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
11017027|NCT01137071|BG000|Baseline|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
11017028|NCT01137071|FG000|Participant Flow|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
11017029|NCT01137071|OG000|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
11017030|NCT01137071|OG000|Outcome|hu3S193|hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
11017031|NCT01137071|OG000|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks.
11017032|NCT01137071|OG000|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.~Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
11017033|NCT01137071|OG000|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
11017034|NCT01137071|OG000|Outcome|Pharmacokinetic|All patients enrolled in the study that received at least 9 doses of investigational product were considered to this analysis.
11017035|NCT01137071|EG000|Reported Event|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
11017036|NCT01137110|BG000|Baseline|Brief LEV|3 days of LEV 1000mg after aSAH
11017037|NCT01137110|BG001|Baseline|Extended LEV|LEV for hospital stay after aSAH
11017038|NCT01137110|BG002|Baseline|Total|Total of all reporting groups
11017039|NCT01137110|FG000|Participant Flow|Levetiracetam 1000mg BID for 3 Days|"Levetiracetam short course: Levetiracetam 1000mg BID x 3 days~This cohort will receive three days of Levetiracetam twice daily for seizure prophylaxis. They will be followed for the entire hospital stay for incidence of seizures. If a seizure occurs, the treating physician will treat per usual therapies. Functional status will be assessed at the patients outpatient follow up if available."
11017040|NCT01137110|FG001|Participant Flow|Levetiracetam 1000mg BID x Hospital Stay|"Levetiracetam Long course: Levetiracetam 1000mg BID x hospital stay~This cohort will receive Levetiracetam for the entire length of hospital stay. They will be closely followed for both incidence of seizures as well as adverse effects of the medication. Functional status will be assessed at the patients outpatient follow up if available."
11017041|NCT01137110|OG000|Outcome|Brief LEV|In-hospital seizure in patient receiving 3 days of LEV compared to Extended LEV that received LEV for length of hospital stay.
11017042|NCT01137110|OG001|Outcome|Extended LEV|In-hospital seizure in patient receiving 3 days of LEV compared to Extended LEV that received LEV for length of hospital stay.
11017043|NCT01137110|EG000|Reported Event|Brief LEV|ADR requiring discontinuation
11017044|NCT01137110|EG001|Reported Event|Extended LEV|ADR requiring discontinue
11017045|NCT01137292|BG000|Baseline|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
11017046|NCT01137292|FG000|Participant Flow|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
11017047|NCT01137292|OG000|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
11017048|NCT01137292|EG000|Reported Event|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
11017049|NCT01137370|BG000|Baseline|Patients With TB|
11017050|NCT01137370|BG001|Baseline|People Without TB|
11017051|NCT01137370|BG002|Baseline|Total|Total of all reporting groups
11017052|NCT01137370|FG000|Participant Flow|Patients With TB|
11341251|NCT03680105|BG005|Baseline|Part 1; Cohort 6; RJX or Placebo|"Participants in Part 1; Cohort 6 received a single dose of 0.500 mL/kg RJX or matching placebo on Day 1.~Cohort 6 subjects comprised a cohort of healthy volunteers aged 51-70 inclusive."
10886220|NCT00492752|FG003|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Participants switched to Open-label Sorafenib treatment from Placebo after unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are the data reported in Reporting Group (RG) 3."
11017053|NCT01137370|FG001|Participant Flow|People Without TB|
11017054|NCT01137370|OG000|Outcome|Patients With TB|
11017055|NCT01137370|OG001|Outcome|People Without TB|
11017056|NCT01137370|EG000|Reported Event|Patients With TB|
11017057|NCT01137370|EG001|Reported Event|People Without TB|
11017058|NCT01137396|BG000|Baseline|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
11341252|NCT03680105|BG006|Baseline|Part 2; Cohort 1; RJX or Placebo|Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX or matching placebo every day for 7 days.
11017059|NCT01137396|BG001|Baseline|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
11017060|NCT01137396|BG002|Baseline|Total|Total of all reporting groups
11017061|NCT01137396|FG000|Participant Flow|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
11017062|NCT01137396|FG001|Participant Flow|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
11017063|NCT01137396|OG000|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
11017064|NCT01137396|OG001|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
11017065|NCT01137396|EG000|Reported Event|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
11017066|NCT01137396|EG001|Reported Event|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
11017067|NCT01137474|BG000|Baseline|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
11017068|NCT01137474|BG001|Baseline|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
11017069|NCT01137474|BG002|Baseline|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
11017070|NCT01137474|BG003|Baseline|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
11017071|NCT01137474|BG004|Baseline|Total|Total of all reporting groups
11017072|NCT01137474|FG000|Participant Flow|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
11017073|NCT01137474|FG001|Participant Flow|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
11017074|NCT01137474|FG002|Participant Flow|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
11017075|NCT01137474|FG003|Participant Flow|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
11017076|NCT01137474|OG000|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
11017077|NCT01137474|OG001|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
11017078|NCT01137474|OG000|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
11017079|NCT01137474|OG001|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
11017080|NCT01137474|EG000|Reported Event|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
11017081|NCT01137474|EG001|Reported Event|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
11017082|NCT01137474|EG002|Reported Event|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
11017083|NCT01137474|EG003|Reported Event|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
11017084|NCT01137539|BG000|Baseline|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
11017085|NCT01137539|FG000|Participant Flow|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
11017086|NCT01137539|OG000|Outcome|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
11017087|NCT01137539|EG000|Reported Event|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
11017088|NCT01137578|BG000|Baseline|All Imaged Participants|Baseline parameters for all participants in Cohorts A, B, and C: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
11017089|NCT01137578|FG000|Participant Flow|Cohort A|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was recently placed and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Imaging procedures occurred on Day 40 ± 20 days relative to catheter placement (Day 0) and included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used for MRI with contrast. No sedation or anesthesia was to be allowed. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
11017090|NCT01137578|FG001|Participant Flow|Cohort B|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT based on radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without gadolinium contrast enhancement) were to be done within 48 hours of each other or, for those with therapeutic anticoagulation, within 24 hours. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT.
11017091|NCT01137578|FG002|Participant Flow|Sub-Study Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
11017092|NCT01137578|OG000|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
11017093|NCT01137578|OG000|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
11017094|NCT01137578|OG001|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
11017095|NCT01137578|OG002|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
11017096|NCT01137578|OG003|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
11017097|NCT01137578|OG004|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
11017098|NCT01137578|OG005|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
11017099|NCT01137578|OG006|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
11017100|NCT01137578|OG007|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
11017101|NCT01137578|OG008|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
11017102|NCT01137578|OG000|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, were switched to Cohort B.
11017103|NCT01137578|OG001|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
11017104|NCT01137578|OG002|Outcome|Cohort C|Participants with a CVC in place and having an MRI for clinical reasons were enrolled.
11017105|NCT01137578|OG000|Outcome|Cohort A Participants <12Years of Age|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Diagnostic imaging procedures included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was allowed.
11017106|NCT01137578|OG001|Outcome|Cohort A Participants 12Years to 18 Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
11066178|NCT01390909|EG000|Reported Event|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
11066179|NCT01390909|EG001|Reported Event|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
10886221|NCT00492752|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
11017107|NCT01137578|OG002|Outcome|Cohort B Participants <12Years of Age|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without contrast enhancement) were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
11017108|NCT01137578|OG003|Outcome|Cohort B Participants 12Years to 18 Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
11017109|NCT01137578|OG004|Outcome|Cohort C Participants <12Years of Age|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC.
11017110|NCT01137578|OG005|Outcome|Cohort C Participants 12Years to 18 Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
11017111|NCT01137578|OG000|Outcome|All Imaged Participants: No Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but no study-related US (either bilateral or unilateral) was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
11017112|NCT01137578|OG001|Outcome|All Imaged Participants: Unilateral Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but a study-related unilateral US instead of a bilateral US was completed. Bilateral US was the protocol-defined procedure but if the participant was not able to complete a bilateral US, then the unilateral US was accepted for evaluation. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
11017113|NCT01137578|OG002|Outcome|All Imaged Participants: No MRI Without Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI without contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
11017114|NCT01137578|OG003|Outcome|All Imaged Participants: No MRI With Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI with contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
11017115|NCT01137578|OG000|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, should have been switched to Cohort B.
11017116|NCT01137578|OG002|Outcome|Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
11066180|NCT01390909|EG002|Reported Event|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
11066181|NCT01390909|EG003|Reported Event|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
10886222|NCT00492752|OG001|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
11017117|NCT01137578|EG000|Reported Event|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
11017118|NCT01137604|BG000|Baseline|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
11017119|NCT01137604|BG001|Baseline|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017120|NCT01137604|BG002|Baseline|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017121|NCT01137604|BG003|Baseline|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017122|NCT01137604|BG004|Baseline|Total|Total of all reporting groups
11017123|NCT01137604|FG000|Participant Flow|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
11017124|NCT01137604|FG001|Participant Flow|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017125|NCT01137604|FG002|Participant Flow|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017126|NCT01137604|FG003|Participant Flow|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017127|NCT01137604|OG000|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
11017128|NCT01137604|OG001|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11225669|NCT02369900|OG000|Outcome|Esmolol Infusion|"Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.~Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs~Esmolol"
11225670|NCT02369900|OG001|Outcome|Standard Care, Saline|"Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs~Saline"
11225671|NCT02369900|EG000|Reported Event|Esmolol Infusion|"Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.~Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs~Esmolol"
11017129|NCT01137604|OG002|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017130|NCT01137604|OG003|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017131|NCT01137604|EG000|Reported Event|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
11017132|NCT01137604|EG001|Reported Event|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017133|NCT01137604|EG002|Reported Event|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11017134|NCT01137604|EG003|Reported Event|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
11225672|NCT02369900|EG001|Reported Event|Standard Care, Saline|"Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs~Saline"
11341253|NCT03680105|BG007|Baseline|Part 2; Cohort 2; RJX or Placebo|Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX or matching placebo every day for 7 days.
11341254|NCT03680105|BG008|Baseline|Part 2; Cohort 3; RJX or Placebo|Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX or matching placebo every day for 7 days.
11341255|NCT03680105|BG009|Baseline|Total|Total of all reporting groups
11017135|NCT01137682|BG000|Baseline|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
11017136|NCT01137682|BG001|Baseline|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
11017137|NCT01137682|BG002|Baseline|Control Arm (Octreotide or Lanreotide)|Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
11017138|NCT01137682|BG003|Baseline|Total|Total of all reporting groups
11017139|NCT01137682|FG000|Participant Flow|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
11017140|NCT01137682|FG001|Participant Flow|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
11017141|NCT01137682|FG002|Participant Flow|Control Arm (Octreotide or Lanreotide)|Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
11017142|NCT01137682|OG000|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
11017143|NCT01137682|OG001|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
11017144|NCT01137682|OG002|Outcome|Control Arm (Octreotide or Lanreotide)|Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
11017145|NCT01137682|OG000|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
11017146|NCT01137682|OG001|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
11017147|NCT01137682|OG002|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
11017148|NCT01137682|OG002|Outcome|Control Arm (Octreotide or Lanreotide) Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled
11017149|NCT01137682|EG000|Reported Event|Pasireotide LAR 40 mg|Pasireotide LAR 40 mg
11017150|NCT01137682|EG001|Reported Event|Pasireotide LAR 60 mg|Pasireotide LAR 60 mg
11017151|NCT01137682|EG002|Reported Event|Cross-over to Pasireotide|Cross-over to pasireotide
11017152|NCT01137786|BG000|Baseline|Iodixanol 320 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
11017153|NCT01137786|BG001|Baseline|Iopamidol 370 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
11017154|NCT01137786|BG002|Baseline|Total|Total of all reporting groups
11017155|NCT01137786|FG000|Participant Flow|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
11017156|NCT01137786|FG001|Participant Flow|Iopamidol 370|Non ionic contrast media comparator : one time administration for PCI
11017157|NCT01137786|OG000|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320.
11017158|NCT01137786|OG001|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320.
11017159|NCT01137786|OG002|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370.
11017160|NCT01137786|OG003|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iopamidol 370.
11017161|NCT01137786|EG000|Reported Event|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
10849316|NCT00295854|OG001|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
11017162|NCT01137786|EG001|Reported Event|Iopamidol 370|Non ionic contrast media comparator : One time administration for PCI
11017163|NCT01137812|BG000|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11017164|NCT01137812|BG001|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11017165|NCT01137812|BG002|Baseline|Total|Total of all reporting groups
11017166|NCT01137812|FG000|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11017167|NCT01137812|FG001|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11017168|NCT01137812|OG000|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11017169|NCT01137812|OG001|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11017170|NCT01137812|EG000|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11017171|NCT01137812|EG001|Reported Event|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
11017172|NCT01137890|BG000|Baseline|Zonisamide|
11017173|NCT01137890|BG001|Baseline|Placebo|
11017174|NCT01137890|BG002|Baseline|Total|Total of all reporting groups
11017175|NCT01137890|FG000|Participant Flow|Zonisamide|"Participants administered blind capsules containing either placebo or zonisamide.~Zonisamide: Eight capsules administered daily in split doses at 22:00 and 09:00.~Cocaine Hydrochloride: Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.~Neurocognitive and Performance Battery: Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.~Smoking Assessments: Participants answer questions about smoking and smoking behaviors are monitored."
11017176|NCT01137890|FG001|Participant Flow|Placebo|"Participants administered only placebo capsules containing lactose.~Placebo: capsules administered in split doses at 22:00 and 09:00.~Cocaine Hydrochloride: Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.~Neurocognitive and Performance Battery: Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.~Smoking Assessments: Participants answer questions about smoking and smoking behaviors are monitored."
11017177|NCT01137890|OG000|Outcome|1mg-0mg|"1mg cocaine - 0mg zonisamide~Both doses are expected to be inactive, thus this arm is viewed as Placebo"
11017178|NCT01137890|OG001|Outcome|1mg-300mg|1mg cocaine - 300mg zonisamide
11017179|NCT01137890|OG002|Outcome|1mg-600mg|1mg cocaine - 600mg zonisamide
11017180|NCT01137890|OG003|Outcome|20mg-0mg|20mg cocaine - 0mg zonisamide
11017181|NCT01137890|OG004|Outcome|20mg-300mg|20mg cocaine - 300mg zonisamide
10886223|NCT00492752|EG000|Reported Event|Sorafenib, All (Double-Blind and Open Label Phase)|Reporting Group 1 (RG 1): All participants randomized to Sorafenib treatment (data from start of treatment until end of trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
11017182|NCT01137890|OG005|Outcome|20mg-600mg|20mg cocaine - 600mg zonisamide
11017183|NCT01137890|OG006|Outcome|40mg-0mg|40mg cocaine - 0mg zonisamide
11017184|NCT01137890|OG007|Outcome|40mg-300mg|40mg cocaine - 300mg zonisamide
11017185|NCT01137890|OG008|Outcome|40mg-600mg|40mg cocaine - 600mg zonisamide
11017186|NCT01137890|OG000|Outcome|Day 1|
11017187|NCT01137890|OG001|Outcome|Day 2|
11017188|NCT01137890|OG002|Outcome|Day 3|
11017189|NCT01137890|OG003|Outcome|Day 4|
11017190|NCT01137890|OG004|Outcome|Day 5|
11017191|NCT01137890|OG005|Outcome|Day 6|
11017192|NCT01137890|OG006|Outcome|Day 7|
11017193|NCT01137890|OG007|Outcome|Day 8|
11017194|NCT01137890|OG008|Outcome|Day 9|
11017195|NCT01137890|OG009|Outcome|Day 10|
11017196|NCT01137890|OG010|Outcome|Day 11|
11017197|NCT01137890|OG011|Outcome|Day 12|
11017198|NCT01137890|OG012|Outcome|Day 13|
11017199|NCT01137890|OG013|Outcome|Day 14|
11017200|NCT01137890|OG014|Outcome|Day 15|
11017201|NCT01137890|OG015|Outcome|Day 16|
11017202|NCT01137890|OG016|Outcome|Day 17|
11017203|NCT01137890|OG017|Outcome|Day 18|
11017204|NCT01137890|OG018|Outcome|Day 19|
11017205|NCT01137890|OG019|Outcome|Day 20|
11017206|NCT01137890|OG020|Outcome|Day 21|
11017207|NCT01137890|OG021|Outcome|Day 22|
11017208|NCT01137890|OG022|Outcome|Day 23|
11017209|NCT01137890|OG023|Outcome|Day 24|
11017210|NCT01137890|OG024|Outcome|Day 25|
11017211|NCT01137890|OG025|Outcome|Day 26|
11017212|NCT01137890|OG026|Outcome|Day 27|
11017213|NCT01137890|OG027|Outcome|Day 28|
11017214|NCT01137890|OG028|Outcome|Day 29|
11017215|NCT01137890|OG029|Outcome|Day 30|
11017216|NCT01137890|OG030|Outcome|Day 31|
11017217|NCT01137890|OG031|Outcome|Day 32|
11017218|NCT01137890|OG032|Outcome|Day 33|
11017219|NCT01137890|OG033|Outcome|Day 34|
11017220|NCT01137890|OG034|Outcome|Day 35|
11017221|NCT01137890|OG035|Outcome|Day 36|
11017222|NCT01137890|OG036|Outcome|Day 37|
11017223|NCT01137890|OG037|Outcome|Day 38|
11017224|NCT01137890|OG038|Outcome|Day 39|
11017225|NCT01137890|EG000|Reported Event|Zonisamide|"Participants administered blind capsules containing either placebo or zonisamide.~Zonisamide: Eight capsules administered daily in split doses at 22:00 and 09:00.~Cocaine Hydrochloride: Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.~Neurocognitive and Performance Battery: Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.~Smoking Assessments: Participants answer questions about smoking and smoking behaviors are monitored."
11017226|NCT01137890|EG001|Reported Event|Placebo|"Participants administered only placebo capsules containing lactose.~Placebo: capsules administered in split doses at 22:00 and 09:00.~Cocaine Hydrochloride: Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.~Neurocognitive and Performance Battery: Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.~Smoking Assessments: Participants answer questions about smoking and smoking behaviors are monitored."
11017227|NCT01138007|BG000|Baseline|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
11017228|NCT01138007|BG001|Baseline|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
11017229|NCT01138007|BG002|Baseline|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
11017230|NCT01138007|BG003|Baseline|Total|Total of all reporting groups
11017231|NCT01138007|FG000|Participant Flow|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
11017232|NCT01138007|FG001|Participant Flow|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
11017233|NCT01138007|FG002|Participant Flow|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
11017234|NCT01138007|OG000|Outcome|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
11017235|NCT01138007|OG001|Outcome|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
11017236|NCT01138007|OG002|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
11017237|NCT01138007|OG000|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
11017238|NCT01138007|OG001|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
11017239|NCT01138007|EG000|Reported Event|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
11017240|NCT01138007|EG001|Reported Event|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
11017241|NCT01138007|EG002|Reported Event|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
11017242|NCT01138046|BG000|Baseline|Lapatinib 1500mg + Paclitaxel 80mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
11017243|NCT01138046|FG000|Participant Flow|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 milligrams (mg) once daily (QD) in combination with intravenous (IV) paclitaxel (80 milligrams per meters squared [mg/m^2]) weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
11017244|NCT01138046|OG000|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
11017245|NCT01138046|EG000|Reported Event|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
11017246|NCT01138098|BG000|Baseline|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
11017247|NCT01138098|BG001|Baseline|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
11017248|NCT01138098|BG002|Baseline|Total|Total of all reporting groups
11017249|NCT01138098|FG000|Participant Flow|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
11341256|NCT03680105|FG000|Participant Flow|Part 1; Cohort 1; RJX or Placebo|Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
11017250|NCT01138098|FG001|Participant Flow|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
11017251|NCT01138098|OG000|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
11017252|NCT01138098|OG001|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
11017253|NCT01138098|EG000|Reported Event|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
11017254|NCT01138098|EG001|Reported Event|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
11017255|NCT01138111|BG000|Baseline|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
11017256|NCT01138111|FG000|Participant Flow|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection of 300 megaBecqerels (MBq) florbetaben, at baseline, at 12 and 24 months
11017257|NCT01138111|OG000|Outcome|Not Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who did not progress to AD during the study
11017258|NCT01138111|OG001|Outcome|Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who progressed to AD during the study
11017259|NCT01138111|OG002|Outcome|Not Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who did not progress to AD during the study
11017260|NCT01138111|OG003|Outcome|Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who progressed to AD during the study
11017261|NCT01138111|OG004|Outcome|Not Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who did not progress to AD during the study
11017262|NCT01138111|OG005|Outcome|Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who progressed to AD during the study
11017263|NCT01138111|OG000|Outcome|Not Progressed to AD (Baseline)|Results from baseline scan for participants with no progression to AD within 2 years after baseline scan
11017264|NCT01138111|OG001|Outcome|Progressed to AD (Baseline)|Results from baseline scan for participants with progression from MCI to AD within 2 years after baseline scan.
11017265|NCT01138111|OG002|Outcome|Not Progressed to AD (12 Month)|Results from 12 month scan for participants with no progression to AD within 2 years after baseline scan.
11017266|NCT01138111|OG003|Outcome|Progressed to AD (12 Month)|Results from 12 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
11017267|NCT01138111|OG004|Outcome|Not Progressed to AD (24 Month)|Results from 24 month scan for participants with no progression to AD within 2 years after baseline scan.
11017268|NCT01138111|OG005|Outcome|Progressed to AD (24 Month)|Results from 24 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
11017269|NCT01138111|OG000|Outcome|Not Progressed to AD (Baseline)|Baseline PET scan results for subjects who did not progress to AD through the end of the two year follow up period
11017270|NCT01138111|OG001|Outcome|Progressed to AD (Baseline)|Baseline PET scan results for subjects who progressed to AD within the two year follow up period
11017271|NCT01138111|OG002|Outcome|Not Progressed to AD (12 Month)|12 month PET scan results for subjects who did not progress to AD through the end of the two year follow up period
11017272|NCT01138111|OG003|Outcome|Progressed to AD (12 Month)|12 month PET scan results for subjects who progressed to AD within the two year follow up period
11017273|NCT01138111|OG004|Outcome|Not Progressed to AD (24 Month)|24 month scan results for subjects who did not progress to AD through the end of the two year follow up period
11017274|NCT01138111|OG005|Outcome|Progressed to AD (24 Month)|24 month PET scan results for subjects who progressed to AD within the two year follow up period
11017275|NCT01138111|OG000|Outcome|Baseline 45 Min|Baseline PET scan at 45 min post-injection
11017276|NCT01138111|OG001|Outcome|Baseline 90 Min|Baseline PET scan at 90 min post-injection
11017277|NCT01138111|OG002|Outcome|12 Month 45 Min|12 month PET scan at 45 min post-injection
11017278|NCT01138111|OG003|Outcome|12 Month 90 Min|12 month PET scan at 90 min post-injection
11017279|NCT01138111|OG004|Outcome|24 Month 45 Min|24 month PET scan at 45 min post-injection
11017280|NCT01138111|OG005|Outcome|24 Month 90 Min|24 month PET scan at 90 min post-injection
11017281|NCT01138111|EG000|Reported Event|MCI Subjects (Initial Drug Administration)|Subjects with AEs following the initial administration of florbetaben (BAY94-9172) at the baseline visit
11017282|NCT01138111|EG001|Reported Event|MCI Subjects (1st Repeat Drug Administration)|Subjects with AEs following the second administration of florbetaben (BAY94-9172) at the 12 month visit
11017283|NCT01138111|EG002|Reported Event|MCI Subjects (2nd Repeat Drug Administration)|Subjects with AEs following the third administration of florbetaben (BAY94-9172) at the 24 month visit
11017284|NCT01138124|BG000|Baseline|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
11017285|NCT01138124|BG001|Baseline|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
11017286|NCT01138124|BG002|Baseline|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm's tumor and cancer metastatic to kidney were excluded.
11017287|NCT01138124|BG003|Baseline|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
11017288|NCT01138124|BG004|Baseline|Total|Total of all reporting groups
11017289|NCT01138124|FG000|Participant Flow|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
11017290|NCT01138124|FG001|Participant Flow|Pancreatic Cancer Controls|"Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site.~The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin."
11017291|NCT01138124|FG002|Participant Flow|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm's tumor and cancer metastatic to kidney were excluded.
11017292|NCT01138124|FG003|Participant Flow|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
11017293|NCT01138124|OG000|Outcome|Cases|Cases
11017294|NCT01138124|OG001|Outcome|Controls|Controls
11017295|NCT01138124|EG000|Reported Event|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
11017296|NCT01138124|EG001|Reported Event|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
11017297|NCT01138124|EG002|Reported Event|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm's tumor and cancer metastatic to kidney were excluded.
11017298|NCT01138124|EG003|Reported Event|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
11017299|NCT01138150|BG000|Baseline|Treximet|Participants randomized to active drug Treximet during acute migraine attack.
11017300|NCT01138150|BG001|Baseline|Sugar Pill|Participants randomized to placebo (sugar pill) during acute migraine attack.
11017301|NCT01138150|BG002|Baseline|Total|Total of all reporting groups
11017302|NCT01138150|FG000|Participant Flow|Active Drug - Sumatriptan/Naproxen|Participants randomized to sumatriptan/naproxen upon presentation of migraine acute attack
11017303|NCT01138150|FG001|Participant Flow|Placebo|Participants randomized to placebo upon presentation with acute migraine attack.
11017304|NCT01138150|OG000|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
11017305|NCT01138150|OG001|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
11017306|NCT01138150|OG002|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
11017307|NCT01138150|OG003|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
11017308|NCT01138150|OG004|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
11017309|NCT01138150|OG005|Outcome|Treatment Non-Responders|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
11017310|NCT01138150|OG000|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
11017311|NCT01138150|OG001|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
11017312|NCT01138150|OG002|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
11017313|NCT01138150|OG003|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
11017314|NCT01138150|OG004|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
11017315|NCT01138150|OG005|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
11017316|NCT01138150|EG000|Reported Event|Treximet|sumatriptan/naproxen sodium: One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
11017317|NCT01138150|EG001|Reported Event|Sugar Pill|Placebo: One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
11017318|NCT01138475|BG000|Baseline|Paricalcitol|
11017319|NCT01138475|BG001|Baseline|Cholecalciferol|
11017320|NCT01138475|BG002|Baseline|Placebo|
11017321|NCT01138475|BG003|Baseline|Total|Total of all reporting groups
11017322|NCT01138475|FG000|Participant Flow|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
11017323|NCT01138475|FG001|Participant Flow|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
11017324|NCT01138475|FG002|Participant Flow|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
11017325|NCT01138475|OG000|Outcome|Paricalcitol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Paricalcitol: 1 microgram by mouth daily for 6 weeks"
11017326|NCT01138475|OG001|Outcome|Cholecalciferol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks"
11017327|NCT01138475|OG002|Outcome|Placebo|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Placebo: Inactive substance, one capsule daily for 6 weeks"
11017328|NCT01138475|OG000|Outcome|Paricalcitol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Paricalcitol: 1 microgram by mouth daily for 6 weeks"
11017329|NCT01138475|OG001|Outcome|Cholecalciferol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks"
11017330|NCT01138475|OG002|Outcome|Placebo|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Placebo: Inactive substance, one capsule daily for 6 weeks"
11017331|NCT01138475|OG000|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
11017332|NCT01138475|OG001|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
11017333|NCT01138475|OG002|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
11017334|NCT01138475|EG000|Reported Event|Paricalcitriol|Paricalcitriol 1 mcg per day 7 days per week
11017335|NCT01138475|EG001|Reported Event|Cholecalciferol|cholecalciferol 5000 units per day, 7 days per week
11017336|NCT01138475|EG002|Reported Event|Placebo|Placebo capsules, one a day 7 days per week
11017337|NCT01138501|BG000|Baseline|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
10849317|NCT00295854|OG002|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
11017338|NCT01138501|FG000|Participant Flow|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
11017339|NCT01138501|OG000|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
11017340|NCT01138501|EG000|Reported Event|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
11017341|NCT01138514|BG000|Baseline|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
11017342|NCT01138514|BG001|Baseline|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
11017343|NCT01138514|BG002|Baseline|Vehicle|Placebo: Placebo
11017344|NCT01138514|BG003|Baseline|Total|Total of all reporting groups
11017345|NCT01138514|FG000|Participant Flow|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
11017346|NCT01138514|FG001|Participant Flow|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
11017347|NCT01138514|FG002|Participant Flow|Vehicle|Placebo: Placebo
11017348|NCT01138514|OG000|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
11017349|NCT01138514|OG001|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
11017350|NCT01138514|OG002|Outcome|Vehicle|Placebo: Placebo
11017351|NCT01138514|OG002|Outcome|Vehicle|Placebo
11017352|NCT01138514|EG000|Reported Event|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
11017353|NCT01138514|EG001|Reported Event|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
11017354|NCT01138514|EG002|Reported Event|Vehicle|Placebo: Placebo
11017355|NCT01138657|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017356|NCT01138657|BG001|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017357|NCT01138657|BG002|Baseline|Total|Total of all reporting groups
11017358|NCT01138657|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017359|NCT01138657|FG001|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017360|NCT01138657|OG000|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017361|NCT01138657|OG001|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017362|NCT01138657|OG002|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017363|NCT01138657|OG003|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017364|NCT01138657|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017365|NCT01138657|EG001|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
11017366|NCT01138735|BG000|Baseline|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
11017367|NCT01138735|BG001|Baseline|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
11017368|NCT01138735|BG002|Baseline|Total|Total of all reporting groups
11017369|NCT01138735|FG000|Participant Flow|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
11017370|NCT01138735|FG001|Participant Flow|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
11017371|NCT01138735|OG000|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
11017372|NCT01138735|OG001|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
11017373|NCT01138735|EG000|Reported Event|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
11017374|NCT01138735|EG001|Reported Event|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
11017375|NCT01138826|BG000|Baseline|Entire Study Population|All participants randomized to any treatment.(Amlodipine tablet first, amlodipine ODT first, and amlodipine ODT without water first).
11341257|NCT03680105|FG001|Participant Flow|Part 1; Cohort 2; RJX or Placebo|Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX or matching placebo on Day 1.
11341258|NCT03680105|FG002|Participant Flow|Part 1; Cohort 3; RJX or Placebo|Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX or matching placebo on Day 1.
11017376|NCT01138826|FG000|Participant Flow|Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
11017377|NCT01138826|FG001|Participant Flow|Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
11017378|NCT01138826|FG002|Participant Flow|Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
11017379|NCT01138826|FG003|Participant Flow|Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
11017380|NCT01138826|FG004|Participant Flow|Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
11017381|NCT01138826|FG005|Participant Flow|Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
11017382|NCT01138826|OG000|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
11017383|NCT01138826|OG001|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
11017384|NCT01138826|OG002|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
11017385|NCT01138826|EG000|Reported Event|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
11017386|NCT01138826|EG001|Reported Event|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
11017387|NCT01138826|EG002|Reported Event|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
11017388|NCT01138917|BG000|Baseline|Experimental: All Participants (Within Patient Control)|Every subject received both interventions (RECELL and 2:1 meshed split-thickness autograft). Two distinct but similar areas of burn injury at least 100 cm2 and second degree depth will be treated according to random assignment (Area A and Area B). One burn injury area receives RECELL (Investigational Treatment) and the other area 2:1 meshed autograft (Control).
11017389|NCT01138917|FG000|Participant Flow|Experimental: All Participants (Within Patient Control)|Every subject received both interventions (RECELL and Control (2:1 meshed split-thickness autograft)). Two distinct but similar areas of burn injury at least 100 cm2 and second degree depth will be treated according to random assignment (Area A and Area B). One burn injury area receives RECELL (Investigational Treatment) and the other area Control (2:1 meshed autograft).
11017390|NCT01138917|OG000|Outcome|RECELL|"Cell suspension prepared using the RECELL device applied to RECELL Recipient Site"
11017391|NCT01138917|OG001|Outcome|Control|"2:1 meshed autograft applied to Control Recipient Site"
11017392|NCT01138917|OG000|Outcome|RECELL|RECELL donor site
11017393|NCT01138917|OG001|Outcome|Control|Control donor site
11017394|NCT01138917|OG000|Outcome|Recipient Site Wound Healing at Week 2|Investigator Assessment of Recipient Site Wound Healing Per-Protocol Population
11017395|NCT01138917|EG000|Reported Event|Experimental: All Participants (Within Patient Control)|"All subjects received cell suspension prepared using the RECELL device applied to RECELL Recipient Site and 2:1 meshed conventional autografting applied to Control Recipient Site"
11017396|NCT01138969|BG000|Baseline|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
11017397|NCT01138969|BG001|Baseline|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
11017398|NCT01138969|BG002|Baseline|Total|Total of all reporting groups
11017399|NCT01138969|FG000|Participant Flow|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
11017400|NCT01138969|FG001|Participant Flow|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
11017401|NCT01138969|OG000|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
11017402|NCT01138969|OG001|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
11017403|NCT01138969|EG000|Reported Event|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
11017404|NCT01138969|EG001|Reported Event|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
11017405|NCT01138995|BG000|Baseline|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
11017406|NCT01138995|BG001|Baseline|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
11017407|NCT01138995|BG002|Baseline|Total|Total of all reporting groups
11017408|NCT01138995|FG000|Participant Flow|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
11017409|NCT01138995|FG001|Participant Flow|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
11017410|NCT01138995|OG000|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
11017411|NCT01138995|OG001|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
11017412|NCT01138995|OG001|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
11017413|NCT01138995|EG000|Reported Event|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO) for 30 weeks."
11017414|NCT01138995|EG001|Reported Event|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
11017415|NCT01139008|BG000|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
11017416|NCT01139008|FG000|Participant Flow|MetroGel® 1% and Finacea 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
11017417|NCT01139008|OG000|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
11017418|NCT01139008|OG001|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
11017419|NCT01139008|OG000|Outcome|MetroGel® 1% and Finacea® Gel 15%|This is a split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid 15% gel was applied topically to the opposite side of the face twice daily for 3 weeks
11017420|NCT01139008|EG000|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
11017421|NCT01139008|EG001|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
11017422|NCT01139021|BG000|Baseline|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
11017423|NCT01139021|BG001|Baseline|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
11017424|NCT01139021|BG002|Baseline|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
11017425|NCT01139021|BG003|Baseline|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
11017426|NCT01139021|BG004|Baseline|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
11017427|NCT01139021|BG005|Baseline|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
11017428|NCT01139021|BG006|Baseline|Total|Total of all reporting groups
11017429|NCT01139021|FG000|Participant Flow|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
11017430|NCT01139021|FG001|Participant Flow|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
11017431|NCT01139021|FG002|Participant Flow|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
11017432|NCT01139021|FG003|Participant Flow|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
11017433|NCT01139021|FG004|Participant Flow|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
11017434|NCT01139021|FG005|Participant Flow|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
11017435|NCT01139021|OG000|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
11017436|NCT01139021|OG001|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
11017437|NCT01139021|OG002|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
11017438|NCT01139021|OG001|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age
11017439|NCT01139021|OG000|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
11017440|NCT01139021|OG001|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
11017441|NCT01139021|OG002|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
11017442|NCT01139021|OG000|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
11017443|NCT01139021|OG000|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
11017444|NCT01139021|OG001|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
11017445|NCT01139021|EG000|Reported Event|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
11017446|NCT01139021|EG001|Reported Event|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 months of age.
11017447|NCT01139021|EG002|Reported Event|B24_26|Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
11017448|NCT01139047|BG000|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
11017449|NCT01139047|FG000|Participant Flow|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
11017450|NCT01139047|OG000|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
11017451|NCT01139047|OG001|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
11017452|NCT01139047|OG000|Outcome|MetroGel® 1% and Finacea Gel® 15%|This was a randomized split-face study where metronidazole 1% gel was applied to one side of the face once daily for 3 weeks and azelaic acid 15 % gel was applied to the opposite side of the face twice daily for 3 weeks
11017453|NCT01139047|EG000|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
11017454|NCT01139047|EG001|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically to the opposite side of the face twice daily for 3 weeks
11017455|NCT01139164|BG000|Baseline|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
11017456|NCT01139164|BG001|Baseline|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
11017457|NCT01139164|BG002|Baseline|Group 3: Regimen C|B-Cell Lymphomas
11017458|NCT01139164|BG003|Baseline|Total|Total of all reporting groups
11017459|NCT01139164|FG000|Participant Flow|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
11017460|NCT01139164|FG001|Participant Flow|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
11017461|NCT01139164|FG002|Participant Flow|Group 3: Regimen C|B-Cell Lymphomas
11017462|NCT01139164|OG000|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
11017463|NCT01139164|OG001|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
11017464|NCT01139164|OG002|Outcome|Group 3: Regimen C|B-Cell Lymphomas
11017465|NCT01139164|EG000|Reported Event|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
11017466|NCT01139164|EG001|Reported Event|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
11017467|NCT01139164|EG002|Reported Event|Group 3: Regimen C|B-Cell Lymphomas
11017468|NCT01139190|BG000|Baseline|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
11017469|NCT01139190|BG001|Baseline|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
11017470|NCT01139190|BG002|Baseline|Total|Total of all reporting groups
11017471|NCT01139190|FG000|Participant Flow|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
11017472|NCT01139190|FG001|Participant Flow|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
11017473|NCT01139190|OG000|Outcome|PL3100|PL3100: Oral administration
11017474|NCT01139190|OG001|Outcome|Naproxen|Naproxen: Oral administration
11017475|NCT01139190|EG000|Reported Event|PL3100|PL3100: Oral administration
11017476|NCT01139190|EG001|Reported Event|Naproxen|Naproxen: Oral administration
11017477|NCT01139411|BG000|Baseline|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
11017478|NCT01139411|BG001|Baseline|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
11017479|NCT01139411|BG002|Baseline|Total|Total of all reporting groups
11017480|NCT01139411|FG000|Participant Flow|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
11017481|NCT01139411|FG001|Participant Flow|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
11017482|NCT01139411|OG000|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
11017483|NCT01139411|OG001|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
11017484|NCT01139411|OG000|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
11017485|NCT01139411|OG001|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
11017486|NCT01139411|EG000|Reported Event|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
11017487|NCT01139411|EG001|Reported Event|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
11017488|NCT01139450|BG000|Baseline|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
11017489|NCT01139450|BG001|Baseline|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
11017490|NCT01139450|BG002|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
11017491|NCT01139450|BG003|Baseline|Total|Total of all reporting groups
11017492|NCT01139450|FG000|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
11017493|NCT01139450|FG001|Participant Flow|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
11017494|NCT01139450|FG002|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
11017495|NCT01139450|OG000|Outcome|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
11017496|NCT01139450|OG001|Outcome|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
11017497|NCT01139450|OG002|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
11017498|NCT01139450|EG000|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
11017499|NCT01139450|EG001|Reported Event|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
11017500|NCT01139450|EG002|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
11017501|NCT01139515|BG000|Baseline|Entire Study Population|All participants randomized to any treatment (Eletriptan 20 mg tablet first, eletriptan 40 mg tablet first, eletriptan 80 mg tablet first, and eletriptan 40 mg 2 hrs apart repeated dose (80 mg in total).
11017502|NCT01139515|FG000|Participant Flow|Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 20 mg tablet in first intervention period; followed by single oral dose of eletriptan 40 mg tablet in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
11017503|NCT01139515|FG001|Participant Flow|Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 40 mg tablet in first intervention period; followed by single oral dose of eletriptan 80 mg tablet in second intervention period; then single oral dose of eletriptan 20 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
11017504|NCT01139515|FG002|Participant Flow|Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg|Single oral dose of eletriptan 80 mg tablet in first intervention period; followed by two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in second intervention period; then single oral dose of eletriptan 40 mg tablet in third intervention period; and single oral dose of eletriptan 20 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
11017505|NCT01139515|FG003|Participant Flow|Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg|Two oral doses of 40 mg eletriptan tablet administered 2 hrs apart tablet in first intervention period; followed by single oral dose of eletriptan 20 mg in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and single oral dose of eletriptan 40 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
11017506|NCT01139515|OG000|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
11017507|NCT01139515|OG001|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
11017508|NCT01139515|OG002|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
11017509|NCT01139515|OG003|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
11017510|NCT01139515|EG000|Reported Event|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
11017511|NCT01139515|EG001|Reported Event|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
11017512|NCT01139515|EG002|Reported Event|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
11017513|NCT01139515|EG003|Reported Event|Eletriptan 40 mg 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
11017514|NCT01139580|BG000|Baseline|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
11017515|NCT01139580|BG001|Baseline|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
11017516|NCT01139580|BG002|Baseline|Total|Total of all reporting groups
11017517|NCT01139580|FG000|Participant Flow|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.
11017518|NCT01139580|FG001|Participant Flow|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
11017519|NCT01139580|OG000|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
11017520|NCT01139580|OG001|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
11017521|NCT01139580|EG000|Reported Event|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
11017522|NCT01139580|EG001|Reported Event|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
11017523|NCT01139658|BG000|Baseline|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
11017524|NCT01139658|BG001|Baseline|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
11017525|NCT01139658|BG002|Baseline|Total|Total of all reporting groups
11017526|NCT01139658|FG000|Participant Flow|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
11017527|NCT01139658|FG001|Participant Flow|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
11017528|NCT01139658|OG000|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
11017529|NCT01139658|OG001|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
11017530|NCT01139658|EG000|Reported Event|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
11017531|NCT01139658|EG001|Reported Event|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
11017532|NCT01139762|BG000|Baseline|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
11017533|NCT01139762|BG001|Baseline|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
11017534|NCT01139762|BG002|Baseline|Total|Total of all reporting groups
11017535|NCT01139762|FG000|Participant Flow|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
11017536|NCT01139762|FG001|Participant Flow|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
11017537|NCT01139762|FG002|Participant Flow|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
11017538|NCT01139762|OG000|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
11017539|NCT01139762|OG001|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
11017540|NCT01139762|EG000|Reported Event|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
11017541|NCT01139762|EG001|Reported Event|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
11017542|NCT01139762|EG002|Reported Event|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
11017543|NCT01139775|BG000|Baseline|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
11017544|NCT01139775|BG001|Baseline|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
11017545|NCT01139775|BG002|Baseline|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
11017546|NCT01139775|BG003|Baseline|Total|Total of all reporting groups
11017547|NCT01139775|FG000|Participant Flow|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 milligrams per square meter (mg/m^2) + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 milligrams (mg)~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered intravenously (IV) over 10 minutes, 1 hour, and 1 hour, respectively."
10886224|NCT00492752|EG001|Reported Event|Placebo, All (Double-Blind and Open Label Phase)|Reporting Group 2 (RG 2): All participants randomized to Sorafenib-matching Placebo (data from start of treatment until end of trial [July 27, 2009]). Treatment for Double-Blind phase (before unblinding [August 19, 2007]): Placebo tablets matching in appearance were orally administered twice daily (bid); Treatment for Open Label phase (after unblinding [August 19, 2007]): Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
11017548|NCT01139775|FG001|Participant Flow|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
11017549|NCT01139775|FG002|Participant Flow|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes and cisplatin was administered IV over 1 hour."
11017550|NCT01139775|OG000|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
11017551|NCT01139775|OG001|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
11017552|NCT01139775|OG000|Outcome|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
11017553|NCT01139775|OG001|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
11017554|NCT01139775|OG002|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
11017555|NCT01139775|EG000|Reported Event|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
11017556|NCT01139775|EG001|Reported Event|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
11017557|NCT01139775|EG002|Reported Event|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
11017558|NCT01139801|BG000|Baseline|Oxytocin|Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
11017559|NCT01139801|BG001|Baseline|Misoprostol|Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
11017560|NCT01139801|BG002|Baseline|Total|Total of all reporting groups
11017561|NCT01139801|FG000|Participant Flow|Oxytocin|Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
11017562|NCT01139801|FG001|Participant Flow|Misoprostol|Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
11017563|NCT01139801|OG000|Outcome|Oxytocin|Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
11017564|NCT01139801|OG001|Outcome|Misoprostol|Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
11017565|NCT01139801|EG000|Reported Event|Oxytocin|Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
11017566|NCT01139801|EG001|Reported Event|Misoprostol|Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
11017567|NCT01139814|BG000|Baseline|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
11017568|NCT01139814|FG000|Participant Flow|Intent-to-Treat|"Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.~Amigo RCS is an accessory for use in the cardiac EP setting to allow the operator to manipulate a steerable cardiac catheter and perform a conventional electrophysiology procedure. The intent of the device is to allow the operator to complete the procedure in a conventional x-ray guided EP lab. Catheter control can be performed while standing (or sitting) some distance from the subject to minimize absorbed radiology dose and minimize operator fatigue from standing for long periods of time with the standard lead aprons/personal protection devices."
11017569|NCT01139814|OG000|Outcome|Intent-to-Treat|A subject was considered Intent-to-treat once the subject was evaluated for the study criteria on the day of procedure, the Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
11017570|NCT01139814|OG000|Outcome|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
11017571|NCT01139814|EG000|Reported Event|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
11017572|NCT01139879|BG000|Baseline|P400|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
11017573|NCT01139879|FG000|Participant Flow|P400|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
11017574|NCT01139879|OG000|Outcome|P400 Support Surface|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
11017575|NCT01139879|OG000|Outcome|P400|The P400 mattress will be placed for a period of 12 weeks for all enrolled patients
11017576|NCT01139879|OG000|Outcome|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
11017577|NCT01139879|EG000|Reported Event|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
11017578|NCT01140061|BG000|Baseline|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
11017579|NCT01140061|BG001|Baseline|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days
11017580|NCT01140061|BG002|Baseline|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
11017581|NCT01140061|BG003|Baseline|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
11017582|NCT01140061|BG004|Baseline|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
11017583|NCT01140061|BG005|Baseline|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
11017584|NCT01140061|BG006|Baseline|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days
11017585|NCT01140061|BG007|Baseline|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
11017586|NCT01140061|BG008|Baseline|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
11017587|NCT01140061|BG009|Baseline|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
11017588|NCT01140061|BG010|Baseline|Total|Total of all reporting groups
11017589|NCT01140061|FG000|Participant Flow|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
11017590|NCT01140061|FG001|Participant Flow|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
11017591|NCT01140061|FG002|Participant Flow|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
11017592|NCT01140061|FG003|Participant Flow|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
11017593|NCT01140061|FG004|Participant Flow|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
11017594|NCT01140061|FG005|Participant Flow|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
11017595|NCT01140061|FG006|Participant Flow|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
11017596|NCT01140061|FG007|Participant Flow|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
11017597|NCT01140061|FG008|Participant Flow|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
11017598|NCT01140061|FG009|Participant Flow|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
11017599|NCT01140061|OG000|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
11017600|NCT01140061|OG001|Outcome|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
11017601|NCT01140061|OG001|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
11017602|NCT01140061|OG002|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
11017603|NCT01140061|OG003|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
11017604|NCT01140061|OG004|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
11017605|NCT01140061|OG005|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
11017606|NCT01140061|EG000|Reported Event|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
11017607|NCT01140061|EG001|Reported Event|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
11017608|NCT01140061|EG002|Reported Event|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
11017609|NCT01140061|EG003|Reported Event|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
11017610|NCT01140061|EG004|Reported Event|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
11017611|NCT01140061|EG005|Reported Event|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
11017612|NCT01140191|BG000|Baseline|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
11017613|NCT01140191|FG000|Participant Flow|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
11017614|NCT01140191|OG000|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
11017615|NCT01140191|EG000|Reported Event|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
11017616|NCT01140295|BG000|Baseline|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
11017617|NCT01140295|BG001|Baseline|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
11017618|NCT01140295|BG002|Baseline|Total|Total of all reporting groups
11017619|NCT01140295|FG000|Participant Flow|1, Miralax|"Miralax colonoscopy preparation~Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
11017620|NCT01140295|FG001|Participant Flow|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
11017621|NCT01140295|OG000|Outcome|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
11066182|NCT01390909|EG004|Reported Event|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
11017622|NCT01140295|OG001|Outcome|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
11017623|NCT01140295|OG000|Outcome|1, Miralax|"Miralax colonoscopy preparation~Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
11017624|NCT01140295|OG001|Outcome|2, Senna|"Senna colonoscopy preparation~Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
11017625|NCT01140295|EG000|Reported Event|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
11017626|NCT01140295|EG001|Reported Event|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
11017627|NCT01140347|BG000|Baseline|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
11017628|NCT01140347|BG001|Baseline|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
11017629|NCT01140347|BG002|Baseline|Total|Total of all reporting groups
11017630|NCT01140347|FG000|Participant Flow|Ramucirumab (IMC-1121B) + BSC|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.~Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator."
11017631|NCT01140347|FG001|Participant Flow|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
11017632|NCT01140347|OG000|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
11017633|NCT01140347|OG001|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
11017634|NCT01140347|EG000|Reported Event|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
11017635|NCT01140347|EG001|Reported Event|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
11017636|NCT01140360|BG000|Baseline|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
11017637|NCT01140360|FG000|Participant Flow|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
11066183|NCT01390909|EG005|Reported Event|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
11341259|NCT03680105|FG003|Participant Flow|Part 1; Cohort 4; RJX or Placebo|Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX or matching placebo on Day 1.
11341260|NCT03680105|FG004|Participant Flow|Part 1; Cohort 5; RJX or Placebo|Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX or matching placebo on Day 1.
11341261|NCT03680105|FG005|Participant Flow|Part 1; Cohort 6; RJX or Placebo|"Participants in Part 1; Cohort 6 received a single dose of 0.500 mL/kg RJX or matching placebo on Day 1.~Cohort 6 subjects comprised a cohort of healthy volunteers aged 51-70 inclusive."
11017638|NCT01140360|OG000|Outcome|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
11017639|NCT01140360|EG000|Reported Event|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
11017640|NCT01140477|BG000|Baseline|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
11017641|NCT01140477|BG001|Baseline|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
11017642|NCT01140477|BG002|Baseline|Total|Total of all reporting groups
11017643|NCT01140477|FG000|Participant Flow|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
11017644|NCT01140477|FG001|Participant Flow|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
11017645|NCT01140477|OG000|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
11017646|NCT01140477|OG001|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
11017647|NCT01140477|EG000|Reported Event|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
11017648|NCT01140477|EG001|Reported Event|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
11017649|NCT01140503|BG000|Baseline|Apremilast|All subjects received apremilast 20mg PO BID
11017650|NCT01140503|FG000|Participant Flow|Apremilast|All subjects received apremilast 20mg PO BID
11017651|NCT01140503|OG000|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
11017652|NCT01140503|EG000|Reported Event|Apremilast|All subjects received apremilast 20mg PO BID
11017653|NCT01140568|BG000|Baseline|Nilotinib|"Patients will take nilotinib twice daily at the standard dose of 400mg taken by mouth twice a day until disease progression or development of unacceptable side effects.~nilotinib: 400mg po (orally) BID (twice daily)"
11017654|NCT01140568|FG000|Participant Flow|Nilotinib|"Patients will take nilotinib twice daily at the standard dose of 400mg taken by mouth twice a day until disease progression or development of unacceptable side effects.~nilotinib: 400mg po (orally) BID (twice daily)"
11017655|NCT01140568|OG000|Outcome|Nilotinib|"Patients will take nilotinib twice daily at the standard dose of 400mg taken by mouth twice a day until disease progression or development of unacceptable side effects.~nilotinib: 400mg po (orally) BID (twice daily)"
11017656|NCT01140568|EG000|Reported Event|Nilotinib|"Patients will take nilotinib twice daily at the standard dose of 400mg taken by mouth twice a day until disease progression or development of unacceptable side effects.~nilotinib: 400mg po (orally) BID (twice daily)"
11017657|NCT01140646|BG000|Baseline|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
11017658|NCT01140646|FG000|Participant Flow|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
11017659|NCT01140646|OG000|Outcome|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
11017660|NCT01140646|EG000|Reported Event|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
11017661|NCT01140815|BG000|Baseline|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
11017662|NCT01140815|BG001|Baseline|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
11017663|NCT01140815|BG002|Baseline|Total|Total of all reporting groups
11017664|NCT01140815|FG000|Participant Flow|Total|The Smith and Nephew Total Knee System
11017665|NCT01140815|FG001|Participant Flow|Deuce|The Journey Deuce Bicompartmental Knee System
11017666|NCT01140815|OG000|Outcome|Total|The Smith and Nephew Total Knee System
11017667|NCT01140815|OG001|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
11017668|NCT01140815|OG000|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
11017669|NCT01140815|OG001|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
11017670|NCT01140815|EG000|Reported Event|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
11017671|NCT01140815|EG001|Reported Event|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
11341262|NCT03680105|FG006|Participant Flow|Part 2; Cohort 1; RJX or Placebo|Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX or matching placebo every day for 7 days.
11017672|NCT01140880|BG000|Baseline|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
11017673|NCT01140880|BG001|Baseline|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
11017674|NCT01140880|BG002|Baseline|Total|Total of all reporting groups
11017675|NCT01140880|FG000|Participant Flow|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
11017676|NCT01140880|FG001|Participant Flow|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
11017677|NCT01140880|OG000|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
11017678|NCT01140880|OG001|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
11017679|NCT01140880|EG000|Reported Event|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
11017680|NCT01140880|EG001|Reported Event|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
11017681|NCT01140906|BG000|Baseline|Placebo|capsules, daily, orally
11017682|NCT01140906|BG001|Baseline|Vortioxetine 15 mg|encapsulated tablets, daily, orally
11017683|NCT01140906|BG002|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
11017684|NCT01140906|BG003|Baseline|Duloxetine 60 mg|encapsulated capsules, daily, orally
11017685|NCT01140906|BG004|Baseline|Total|Total of all reporting groups
11017686|NCT01140906|FG000|Participant Flow|Placebo|capsules, daily, orally
11017687|NCT01140906|FG001|Participant Flow|Vortioxetine 15 mg|encapsulated tablets, daily, orally
11017688|NCT01140906|FG002|Participant Flow|Vortioxetine 20 mg|encapsulated tablets, daily, orally
11017689|NCT01140906|FG003|Participant Flow|Duloxetine 60 mg|encapsulated capsules, daily, orally
11017690|NCT01140906|OG000|Outcome|Placebo|capsules, daily, orally
11017691|NCT01140906|OG001|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
11017692|NCT01140906|OG002|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
11017693|NCT01140906|OG003|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
11017694|NCT01140906|EG000|Reported Event|Placebo|
11017695|NCT01140906|EG001|Reported Event|Vortioxetine 15 mg|
11017696|NCT01140906|EG002|Reported Event|Vortioxetine 20 mg|
11017697|NCT01140906|EG003|Reported Event|Duloxetine 60 mg|
11017698|NCT01141049|BG000|Baseline|Gabapentin|"Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.~Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week."
11017699|NCT01141049|BG001|Baseline|Placebo|"Placebo capsules will be administered TID.~Placebo: Placebo, TID"
11017700|NCT01141049|BG002|Baseline|Total|Total of all reporting groups
11066184|NCT01390909|EG006|Reported Event|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
11066185|NCT01390909|EG007|Reported Event|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
11017701|NCT01141049|FG000|Participant Flow|Gabapentin|"Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.~Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week."
11017702|NCT01141049|FG001|Participant Flow|Placebo|"Placebo capsules will be administered TID.~Placebo: Placebo, TID"
11017703|NCT01141049|OG000|Outcome|Gabapentin|"Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.~Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week."
11017704|NCT01141049|OG001|Outcome|Placebo|"Placebo capsules will be administered TID.~Placebo: Placebo, TID"
11017705|NCT01141049|EG000|Reported Event|Gabapentin|"Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.~Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week."
11017706|NCT01141049|EG001|Reported Event|Placebo|"Placebo capsules will be administered TID.~Placebo: Placebo, TID"
11017707|NCT01141075|BG000|Baseline|Ataluren|"Cycle 1: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 5 mg/kg (morning), 5 mg/kg (midday), and 10 mg/kg (evening); there was then an interval of 21 up to 42 days without treatment.~Cycle 2: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening); there was then an interval of 14 days without treatment."
11017708|NCT01141075|FG000|Participant Flow|Ataluren|"Cycle 1: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 5 milligrams/kilograms (mg/kg) (morning), 5 mg/kg (midday), and 10 mg/kg (evening); there was then an interval of 21 up to 42 days without treatment.~Cycle 2: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening); there was then an interval of 14 days without treatment."
11017709|NCT01141075|OG000|Outcome|Ataluren|"Cycle 1: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 5 mg/kg (morning), 5 mg/kg (midday), and 10 mg/kg (evening); there was then an interval of 21 up to 42 days without treatment.~Cycle 2: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening); there was then an interval of 14 days without treatment."
11017710|NCT01141075|EG000|Reported Event|Ataluren|"Cycle 1: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 5 mg/kg (morning), 5 mg/kg (midday), and 10 mg/kg (evening); there was then an interval of 21 up to 42 days without treatment.~Cycle 2: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening); there was then an interval of 14 days without treatment."
11017711|NCT01141205|BG000|Baseline|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
11017712|NCT01141205|BG001|Baseline|Saline|Saline injection
11017713|NCT01141205|BG002|Baseline|Total|Total of all reporting groups
11017714|NCT01141205|FG000|Participant Flow|AFO-18|18 peptides representing 15 CD8 and 3 CD4 epitopes on HIV-1 plus 1 CD4 T helper epitope unrelated to HIV in an adjuvant (CAF01). Total 4.5 mg peptide (250 micro gram of each peptide) in CAF01 adjuvant. Total volume of 1.25 ml was injected i.m. (in m. deltoideus) at weeks 0, 2, 4, 8
11017715|NCT01141205|FG001|Participant Flow|Saline|Placebo was Sterile saline injection, 1.25 ml i.m. (in m. deltoideus) at each vaccination weeks 0, 2, 4, 8
11017716|NCT01141205|OG000|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
11017717|NCT01141205|OG001|Outcome|Placebo|participants receiving saline
11017718|NCT01141205|OG000|Outcome|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
11017719|NCT01141205|OG001|Outcome|Placebo Saline|Saline injection
11017720|NCT01141205|OG000|Outcome|Vaccinee|participants receiving active HIV-1 peptide vaccine in CAF01 adjuvant i.m.
11017721|NCT01141205|OG001|Outcome|Saline|Placebo participants receiving sterile saline i.m.
11017722|NCT01141205|EG000|Reported Event|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
11017723|NCT01141205|EG001|Reported Event|Saline|Saline injection
11017724|NCT01141283|BG000|Baseline|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
11017725|NCT01141283|FG000|Participant Flow|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
11017726|NCT01141283|OG000|Outcome|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
11017727|NCT01141283|EG000|Reported Event|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
11017728|NCT01141374|BG000|Baseline|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
11017729|NCT01141374|BG001|Baseline|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
11017730|NCT01141374|BG002|Baseline|Control Group|untreated group
11017731|NCT01141374|BG003|Baseline|Total|Total of all reporting groups
11017732|NCT01141374|FG000|Participant Flow|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
11017733|NCT01141374|FG001|Participant Flow|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
11017734|NCT01141374|FG002|Participant Flow|Control Group|untreated group
11017735|NCT01141374|OG000|Outcome|Control Group|Without intervention
11017736|NCT01141374|OG001|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
11017737|NCT01141374|OG002|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
11017738|NCT01141374|OG001|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
11017739|NCT01141374|OG002|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
11017740|NCT01141374|EG000|Reported Event|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
11017741|NCT01141374|EG001|Reported Event|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
10886225|NCT00492752|EG002|Reported Event|Placebo, Open Label Only (Participants Switched to Sorafenib)|Reporting Group 3 (RG 3): Participants switched to Open-label Sorafenib treatment from Placebo ( Data after unblinding [August 19, 2007] until end of this trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
11017742|NCT01141374|EG002|Reported Event|Control Group|untreated group
11017743|NCT01141478|BG000|Baseline|Proton Beam Radiotherapy Plus Sorafenib|"A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.~Proton Beam Radiotherapy: Fifteen consecutive sessions~Sorafenib: 400 mg po bid"
11017744|NCT01141478|BG001|Baseline|Sorafenib|"Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.~Sorafenib: 400 mg po bid"
11017745|NCT01141478|BG002|Baseline|Total|Total of all reporting groups
11017746|NCT01141478|FG000|Participant Flow|Proton Beam Radiotherapy Plus Sorafenib|"A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.~Proton Beam Radiotherapy: Fifteen consecutive sessions~Sorafenib: 400 mg po bid"
11017747|NCT01141478|FG001|Participant Flow|Sorafenib|"Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.~Sorafenib: 400 mg po bid"
11017748|NCT01141478|OG000|Outcome|Proton Beam Radiotherapy Plus Sorafenib|"A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.~Proton Beam Radiotherapy: Fifteen consecutive sessions~Sorafenib: 400 mg po bid"
11017749|NCT01141478|OG001|Outcome|Sorafenib|"Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.~Sorafenib: 400 mg po bid"
11017750|NCT01141478|EG000|Reported Event|Proton Beam Radiotherapy Plus Sorafenib|"A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.~Proton Beam Radiotherapy: Fifteen consecutive sessions~Sorafenib: 400 mg po bid"
11017751|NCT01141478|EG001|Reported Event|Sorafenib|"Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.~Sorafenib: 400 mg po bid"
11017752|NCT01141491|BG000|Baseline|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
11017753|NCT01141491|BG001|Baseline|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
11017754|NCT01141491|BG002|Baseline|Total|Total of all reporting groups
11017755|NCT01141491|FG000|Participant Flow|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
11017756|NCT01141491|FG001|Participant Flow|Arm B - OPT-821 Immunologic Adjuvant|Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
11017757|NCT01141491|OG000|Outcome|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
11017758|NCT01141491|OG001|Outcome|Arm B - OPT-821 Immunologic Adjuvant|"Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84~OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84"
11341263|NCT03680105|FG007|Participant Flow|Part 2; Cohort 2; RJX or Placebo|Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX or matching placebo every day for 7 days.
11341264|NCT03680105|FG008|Participant Flow|Part 2; Cohort 3; RJX or Placebo|Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX or matching placebo every day for 7 days.
11341265|NCT03680105|OG000|Outcome|Part 1; Placebo|Participants in Part 1 received a single saline placebo on Day 1.
11341266|NCT03680105|OG001|Outcome|Part 1; Cohort 1; RJX|Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
11017759|NCT01141491|EG000|Reported Event|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
11017760|NCT01141491|EG001|Reported Event|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
11017761|NCT01141569|BG000|Baseline|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11017762|NCT01141569|FG000|Participant Flow|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11017763|NCT01141569|OG000|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11017764|NCT01141569|EG000|Reported Event|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11017765|NCT01141595|BG000|Baseline|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
11017766|NCT01141595|FG000|Participant Flow|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
11017767|NCT01141595|OG000|Outcome|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
11017768|NCT01141595|EG000|Reported Event|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
11017769|NCT01141608|BG000|Baseline|Vigorous Intensity High Dose Exercise|"Usual Care Augmented with Vigorous Intensity High Dose Exercise~Vigorous Intensity High Dose Exercise: Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate."
11017770|NCT01141608|BG001|Baseline|Health Education Intervention|"Health Education Intervention~Health Education Intervention: Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials."
11017771|NCT01141608|BG002|Baseline|Total|Total of all reporting groups
11017772|NCT01141608|FG000|Participant Flow|Vigorous Intensity High Dose Exercise|"Usual Care Augmented with Vigorous Intensity High Dose Exercise~Vigorous Intensity High Dose Exercise: Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate."
11017773|NCT01141608|FG001|Participant Flow|Health Education Intervention|"Health Education Intervention~Health Education Intervention: Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials."
11017774|NCT01141608|OG000|Outcome|Vigorous Intensity High Dose Exercise|Participants randomized to Exercise completed supervised exercise sessions 3 times per week during the 12-week acute phase. Exercise was prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% of maximal heart rate (HRmax).
11017775|NCT01141608|OG001|Outcome|Health Education Intervention|Participants randomized to Health Education also completed 3 visits per week during the 12-week acute phase. Health Education consisted of one-on-one sessions in which information on health-related topics (e.g., cancer, heart disease, mental health) was distributed via didactics, websites, audio, video, and written materials.
11017776|NCT01141608|EG000|Reported Event|Vigorous Intensity High Dose Exercise|"Usual Care Augmented with Vigorous Intensity High Dose Exercise~Vigorous Intensity High Dose Exercise: Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate."
11017777|NCT01141608|EG001|Reported Event|Health Education Intervention|"Health Education Intervention~Health Education Intervention: Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials."
11017778|NCT01141647|BG000|Baseline|24-Month Supported Employment|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
11017779|NCT01141647|FG000|Participant Flow|24-Month Supported Employment|Evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
11017780|NCT01141647|OG000|Outcome|24-Month Supported Employment|Participants in Supported Employment.
11017781|NCT01141647|OG000|Outcome|48-Month Supported Employment|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
11017782|NCT01141647|OG000|Outcome|Early Stage|Interview data from clinical staff during year 1.
11017783|NCT01141647|OG001|Outcome|Mid Stage|Interview data from clinical staff from year 2.
11017784|NCT01141647|OG002|Outcome|Late Stage|Interview data from clinical staff in year 3.
11017785|NCT01141647|OG001|Outcome|Participants in SCI-VIP Standard Care|Standard Care group from SCI-VIP trial (NCT00117806): Standard care varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
11017786|NCT01141647|EG000|Reported Event|Baseline Sample (N=1047)|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
11017787|NCT01141660|BG000|Baseline|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
11017788|NCT01141660|BG001|Baseline|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
11017789|NCT01141660|BG002|Baseline|Total|Total of all reporting groups
11017790|NCT01141660|FG000|Participant Flow|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
11017791|NCT01141660|FG001|Participant Flow|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
11017792|NCT01141660|OG000|Outcome|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
11017793|NCT01141660|OG001|Outcome|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
11017794|NCT01141660|EG000|Reported Event|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
11017795|NCT01141660|EG001|Reported Event|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
11017796|NCT01141725|BG000|Baseline|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~bendamustine hydrochloride: Given IV~idarubicin: Given IV"
11017797|NCT01141725|FG000|Participant Flow|Bendamustine Dose of 45mg/m2/Day|"Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
11017798|NCT01141725|FG001|Participant Flow|Bendamustine Dose of 60mg/m2/Day|"Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
11017799|NCT01141725|FG002|Participant Flow|Bendamustine Dose of 75mg/m2/Day|"Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
11017800|NCT01141725|OG000|Outcome|Treatment A|"Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
11017801|NCT01141725|OG001|Outcome|Treatment B|"Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
11017802|NCT01141725|OG002|Outcome|Treatment C|"Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
11017803|NCT01141725|OG000|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~bendamustine hydrochloride: Given IV~idarubicin: Given IV"
11017804|NCT01141725|EG000|Reported Event|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~bendamustine hydrochloride: Given IV~idarubicin: Given IV~Adverse event report was not collected by dose level."
11017805|NCT01141907|BG000|Baseline|Heart Failure Self Care Support|The goal of the Heart Failure Self Care Support Intervention (Navigator Program), delivered by a nurse and community health navigator team over 3 months post discharge from the index hospitalization, was to improve care transitions by providing patients with tools and support that promote knowledge and skills for HF self care as they transition from hospital to home. The multifaceted Navigator Intervention included the following intervention components: HF home automated telemonitoring support, medication and symptom self management, patient-centered record, HF care follow up, and activation of key supporter.
11017806|NCT01141907|BG001|Baseline|Usual Heart Failure Care|Usual care for HF patients included the following: 1) Referral to HF clinic if the patient has no usual source of HF outpatient care, 2) HF patient education by HF care coordinator (advanced practice nurse), and 3) HF self care guide. All participants were treated by their usual source of HF care in the usual manner.
11017807|NCT01141907|BG002|Baseline|Total|Total of all reporting groups
11066186|NCT01390948|BG000|Baseline|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
11017808|NCT01141907|FG000|Participant Flow|Heart Failure Self Care Support|Navigator Team Intervention: The intervention is aimed at controlling heart failure (HF) and preventing exacerbations and hospitalizations by improving self management behaviors with the support of the Home Automated Telemonitoring (HAT) system. The intervention will be delivered by a RN-community health navigator (CHN) team over three months to HF patients and their caregivers in their home and via telephone and HAT system. The intervention will be initiated during the index hospitalization or as soon as possible after randomization. The RN-CHN team will collaborate with the participants, their caregivers, and their usual source of HF care. Intervention strategies include tracking of weight and HF symptoms to provide automated feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and using a patient centered record to promote communication with providers.
11017809|NCT01141907|FG001|Participant Flow|Usual Heart Failure Care|Usual heart failure care: Participants assigned to usual care are treated by their usual source of HF care in the usual manner and in accordance with the American College of Cardiology/American Heart Association Guidelines for the management of HF. Usual care for HF patients admitted to Johns Hopkins Hospital also includes the following: 1) Referral to HF clinic if the patient has no usual source of care and 2) HF patient education booklet.
11017810|NCT01141907|OG000|Outcome|Heart Failure Self Care Support|The goal of the Heart Failure Self Care Support Intervention (Navigator Program), delivered by a nurse and community health navigator team over 3 months post discharge from the index hospitalization, was to improve care transitions by providing patients with tools and support that promote knowledge and skills for HF self care as they transition from hospital to home. The multifaceted Navigator Intervention included the following intervention components: HF home automated telemonitoring support, medication and symptom self management, patient-centered record, HF care follow up, and activation of key supporter.
11017811|NCT01141907|OG001|Outcome|Usual Heart Failure Care|Usual care for HF patients included the following: 1) Referral to HF clinic if the patient has no usual source of HF outpatient care, 2) HF patient education by HF care coordinator (advanced practice nurse), and 3) HF self care guide. All participants were treated by their usual source of HF care in the usual manner.
11017812|NCT01141907|EG000|Reported Event|Heart Failure Self Care Support|
11017813|NCT01141907|EG001|Reported Event|Usual Heart Failure Care|
11017814|NCT01142089|BG000|Baseline|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
11017815|NCT01142089|BG001|Baseline|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
11017816|NCT01142089|BG002|Baseline|Total|Total of all reporting groups
11017817|NCT01142089|FG000|Participant Flow|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
11017818|NCT01142089|FG001|Participant Flow|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
11017819|NCT01142089|OG000|Outcome|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
11017820|NCT01142089|OG001|Outcome|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
11017821|NCT01142089|EG000|Reported Event|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
11017822|NCT01142089|EG001|Reported Event|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
11017823|NCT01142115|BG000|Baseline|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
11017824|NCT01142115|FG000|Participant Flow|SpeediCath First, Then Monza|Catheterization with SpeediCath catheter on visit 1. Catheterization with Monza catheter on visit 2.
11017825|NCT01142115|FG001|Participant Flow|Monza First, Then SpeediCath|Catheterization with Monza catheter on visit 1. Catheterization with SpeediCath catheter on visit 2.
11017826|NCT01142115|OG000|Outcome|Monza|Test product
11017827|NCT01142115|OG001|Outcome|SpeediCath|Control Product
11017828|NCT01142115|EG000|Reported Event|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
11017829|NCT01142193|BG000|Baseline|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
11017830|NCT01142193|BG001|Baseline|Placebo|Placebo
11017831|NCT01142193|BG002|Baseline|Total|Total of all reporting groups
11017832|NCT01142193|FG000|Participant Flow|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
11017833|NCT01142193|FG001|Participant Flow|Placebo|Placebo
11017834|NCT01142193|OG000|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
11017835|NCT01142193|OG001|Outcome|Placebo|Placebo
11017836|NCT01142193|EG000|Reported Event|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
11017837|NCT01142193|EG001|Reported Event|Placebo|Placebo
11341267|NCT03680105|OG002|Outcome|Part 1; Cohort 2; RJX|Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX on Day 1.
11341268|NCT03680105|OG003|Outcome|Part 1; Cohort 3; RJX|Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX on Day 1.
11341269|NCT03680105|OG004|Outcome|Part 1; Cohort 4; RJX|Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX on Day 1.
11341270|NCT03680105|OG005|Outcome|Part 1; Cohort 5; RJX|Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX on Day 1.
11341271|NCT03680105|OG006|Outcome|Part 1; Cohort 6; RJX|"Participants in Part 1; Cohort 6 received a single dose of 0.500 mL/kg RJX Day 1.~Cohort 6 subjects comprised a cohort of healthy volunteers aged 51-70 inclusive."
11017838|NCT01142232|BG000|Baseline|Phase I, Dose Level 1|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
11017839|NCT01142232|BG001|Baseline|Phase I, Dose Level 2|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
11017840|NCT01142232|BG002|Baseline|Phase I, Dose Level 3|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
11017841|NCT01142232|BG003|Baseline|Phase I, Dose Level 4|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
11017842|NCT01142232|BG004|Baseline|Phase II|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
11017843|NCT01142232|BG005|Baseline|Total|Total of all reporting groups
11017844|NCT01142232|FG000|Participant Flow|Phase I, Dose Level 1|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
11017845|NCT01142232|FG001|Participant Flow|Phase I, Dose Level 2|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
11017846|NCT01142232|FG002|Participant Flow|Phase I, Dose Level 3|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
11017847|NCT01142232|FG003|Participant Flow|Phase I, Dose Level 4|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
11017848|NCT01142232|FG004|Participant Flow|Phase II|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
11017849|NCT01142232|OG000|Outcome|Phase I, Dose Level 1|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
11017850|NCT01142232|OG001|Outcome|Phase I, Dose Level 2|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
11017851|NCT01142232|OG002|Outcome|Phase I, Dose Level 3|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
11017852|NCT01142232|OG003|Outcome|Phase I, Dose Level 4|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
11017853|NCT01142232|OG000|Outcome|Phase II|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
11017854|NCT01142232|EG000|Reported Event|Phase I, Dose Level 1|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
11017855|NCT01142232|EG001|Reported Event|Phase I, Dose Level 2|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
11017856|NCT01142232|EG002|Reported Event|Phase I, Dose Level 3|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
11017857|NCT01142232|EG003|Reported Event|Phase I, Dose Level 4|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
11017858|NCT01142232|EG004|Reported Event|Phase II|All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
11017859|NCT01142297|BG000|Baseline|Dental Implant|"standard SLA surface and chemically modified surface~dental implant : standard SLA surface and modified dental implant : chemically modified surface"
11017860|NCT01142297|FG000|Participant Flow|Dental Implant|standard SLA surface and chemically-modified surface implant
11017861|NCT01142297|OG000|Outcome|SLA Minimum ISQ HbA1c<9.5|"standard SLA surface~dental implant : standard SLA surface"
11017862|NCT01142297|OG001|Outcome|Modified SLA Minimum ISQ HbA1c<9.5|"chemically modified surface~modified dental implant : chemically modified surface"
11017863|NCT01142297|OG000|Outcome|Clinical Success of Implants|Successful outcome of implant after one year
11017864|NCT01142297|EG000|Reported Event|Dental Implant|"standard SLA surface~dental implant : standard SLA surface"
11017865|NCT01142297|EG001|Reported Event|Modified Dental Implant|"chemically modified surface~modified dental implant : chemically modified surface"
11017866|NCT01142310|BG000|Baseline|Lamotrigine|Participants took Lamotrigine beginning at 25mg/day and increased to a dose of 400mg/day over 10 weeks using a fixed scheduled.
11017867|NCT01142310|BG001|Baseline|Placebo|Placebo administered the same as the Lamotrigine.
11017868|NCT01142310|BG002|Baseline|Total|Total of all reporting groups
11017869|NCT01142310|FG000|Participant Flow|Lamotrigine|Participants took 25mg of Lamotrigine PO QD for two weeks. Dose was increased to 50mg PO QD at Week 2 for two weeks. Increased to 100mg PO QD at Week 4. Increased to 150mg PO QD at Week 5. Increased to 200mg PO QD at Week 6. Increased to 250mg PO QD at Week 7. Increased to 300mg PO QD at Week 8. Increased to 350mg PO QD at Week 9. Increased to 400mg PO QD at Week 10. Participants stayed at 400mg PO QD from Week 10 to Week 48.
11017870|NCT01142310|FG001|Participant Flow|Placebo|Placebo was administered the same as the Lamotrigine dose titration described.
11017871|NCT01142310|OG000|Outcome|Lamotrigine|Participants took 25mg of Lamotrigine PO QD for two weeks. Dose was increased to 50mg PO QD at Week 2 for two weeks. Increased to 100mg PO QD at Week 4. Increased to 150mg PO QD at Week 5. Increased to 200mg PO QD at Week 6. Increased to 250mg PO QD at Week 7. Increased to 300mg PO QD at Week 8. Increased to 350mg PO QD at Week 9. Increased to 400mg PO QD at Week 10. Participants stayed at 400mg PO QD from Week 10 to Week 48.
11017872|NCT01142310|OG001|Outcome|Placebo|Placebo was administered the same as the Lamotrigine dose titration described.
11017873|NCT01142310|EG000|Reported Event|Lamotrigine|Participants took Lamotrigine beginning at 25mg PO QD and increased to a dose of 400mg PO QD over 10 weeks using a fixed scheduled.
11017874|NCT01142310|EG001|Reported Event|Placebo|Placebo was administered the same as Lamotrigine.
11017875|NCT01142323|BG000|Baseline|Fenofibrate|fenofibrate 160 mg po daily
11017876|NCT01142323|FG000|Participant Flow|Fenofibrate|fenofibrate 160 mg po daily
11017877|NCT01142323|OG000|Outcome|Baseline|Prior to drug intervention
11017878|NCT01142323|OG001|Outcome|At 6 Months|fenofibrate 160 mg/day
11017879|NCT01142323|OG000|Outcome|Fenofibrate|"fenofibrate 160 mg po daily~fenofibrate: 160 mg po daily"
11017880|NCT01142323|EG000|Reported Event|Fenofibrate|fenofibrate 160 mg po daily
11017881|NCT01142336|BG000|Baseline|Placebo|Placebo 1 tablet qHS for 1 year
11017882|NCT01142336|BG001|Baseline|Simvastatin|Simvastatin 40mg qHS for 1 year
11017883|NCT01142336|BG002|Baseline|Total|Total of all reporting groups
11017884|NCT01142336|FG000|Participant Flow|Simvastatin|Simvastatin 40mg qHS for 1 year
11017885|NCT01142336|FG001|Participant Flow|Placebo|Placebo 1 tablet qHS for 1 year
11017886|NCT01142336|OG000|Outcome|Placebo|1 tab qHS for 1 year
11017887|NCT01142336|OG001|Outcome|Simvastatin|40mg qHS for 1 year
11017888|NCT01142336|OG000|Outcome|Placebo|1 tablet qHS for 1 year
11017889|NCT01142336|OG000|Outcome|Placebo|Placebo 1 tablet qHS for 1 year
11017890|NCT01142336|OG001|Outcome|Simvastatin|Simvastatin 40mg qHS for 1 year
11017891|NCT01142336|EG000|Reported Event|Simvastatin|Simvastatin 40mg qHS for 1 year
11017892|NCT01142336|EG001|Reported Event|Placebo|Placebo 1 tablet qHS for 1 year
11017893|NCT01142466|BG000|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
11017894|NCT01142466|BG001|Baseline|No Treatment|Participants in this group did not receive any treatment.
11017895|NCT01142466|BG002|Baseline|Total|Total of all reporting groups
11017896|NCT01142466|FG000|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
11017897|NCT01142466|FG001|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
11017898|NCT01142466|OG000|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
11017899|NCT01142466|OG001|Outcome|No Treatment|Participants in this group did not receive any treatment.
11017900|NCT01142466|EG000|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
11017901|NCT01142466|EG001|Reported Event|No Treatment|Participants in this group did not receive any treatment.
11017902|NCT01142661|BG000|Baseline|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
11017903|NCT01142661|FG000|Participant Flow|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
11017904|NCT01142661|OG000|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
11017905|NCT01142661|EG000|Reported Event|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
11017906|NCT01142726|BG000|Baseline|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
11017907|NCT01142726|BG001|Baseline|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
11017908|NCT01142726|BG002|Baseline|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
11017909|NCT01142726|BG003|Baseline|Total|Total of all reporting groups
11017910|NCT01142726|FG000|Participant Flow|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept subcutaneous (SC) 125 mg/week and MTX.
11017911|NCT01142726|FG001|Participant Flow|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
11017912|NCT01142726|FG002|Participant Flow|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
11017913|NCT01142726|OG000|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
11017914|NCT01142726|OG001|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
11017915|NCT01142726|OG000|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
11017916|NCT01142726|OG001|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
11017917|NCT01142726|OG002|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
11017918|NCT01142726|OG000|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
11017919|NCT01142726|OG001|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
11017920|NCT01142726|OG002|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months~Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
11017921|NCT01142726|OG000|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
11017922|NCT01142726|OG001|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
11017923|NCT01142726|OG002|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
11017924|NCT01142726|EG000|Reported Event|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC 125 mg/week and MTX. Safety data was collected from Day 1 to 56 days post last dose.
11017925|NCT01142726|EG001|Reported Event|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
11341272|NCT03680105|OG007|Outcome|Part 2; Placebo|Participants in Part 2 received a dose of saline placebo every day for 7 days.
11341273|NCT03680105|OG008|Outcome|Part 2; Cohort 1; RJX|Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX every day for 7 days.
11341274|NCT03680105|OG009|Outcome|Part 2; Cohort 2; RJX|Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX every day for 7 days.
11341275|NCT03680105|OG010|Outcome|Part 2; Cohort 3; RJX|Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX every day for 7 days.
11341276|NCT03680105|EG000|Reported Event|Part 1; Placebo|Participants in Part 1 received a single saline placebo on Day 1.
11341277|NCT03680105|EG001|Reported Event|Part 1; Cohort 1; RJX|Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX on Day 1.
11017926|NCT01142726|EG002|Reported Event|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
11017927|NCT01142791|BG000|Baseline|ExAblate Treatment|ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
11017928|NCT01142791|FG000|Participant Flow|ExAblate Treatment|ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation. Phase IV enhanced sonication technique.
11017929|NCT01142791|FG001|Participant Flow|Additional Safety Population Particpants|Per protocol 6 participants receiving only 1 sonication were added to the 115 ExAblate treated subjects to compose the full safety analysis population of 121. These 6 were included in adverse event reporting only, not in baseline or efficacy analyses.
11017930|NCT01142791|OG000|Outcome|ExAblate Treatment|ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation. Phase IV enhanced sonication technique.
11017931|NCT01142791|EG000|Reported Event|ExAblate Treatment|ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation. Phase IV enhanced sonication technique.
11017932|NCT01142908|BG000|Baseline|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
11017933|NCT01142908|BG001|Baseline|Education Control|The education control group - these participants will receive educational material about CVD reduction.
11017934|NCT01142908|BG002|Baseline|Total|Total of all reporting groups
11017935|NCT01142908|FG000|Participant Flow|Pharmacist CVD|The pharmacist cardiovascular (CVD) intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
11017936|NCT01142908|FG001|Participant Flow|Education Control|The education control group - these participants will receive educational material about CVD reduction.
11017937|NCT01142908|OG000|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
11017938|NCT01142908|OG001|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
11017939|NCT01142908|EG000|Reported Event|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
11017940|NCT01142908|EG001|Reported Event|Education Control|The education control group - these participants will receive educational material about CVD reduction.
11017941|NCT01142947|BG000|Baseline|Beclomethasone Dipropionate (BD)|"Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in pulmonary function and asthma control. These change will be used as phenotypes in a genetic association study. There is no placebo group.~beclomethasone dipropionate: 160 mcg twice a day (320 mcg per day total)"
11017942|NCT01142947|FG000|Participant Flow|Beclomethasone Dipropionate (BD)|"Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in asthma control. This change will be the phenotype used in discovery for the genetic association study. There is no placebo group.~beclomethasone dipropionate: 160 mcg twice a day (320 mcg per day total)"
11017943|NCT01142947|OG000|Outcome|Beclomethasone Dipropionate (BD)|"Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in pulmonary function and asthma control. These change will be used as phenotypes in a genetic association study. There is no placebo group.~beclomethasone dipropionate: 160 mcg twice a day (320 mcg per day total)"
11017944|NCT01142947|EG000|Reported Event|Beclomethasone Dipropionate (BD)|"Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in asthma control. This change will be the phenotype used in discovery for the genetic association study. There is no placebo group.~beclomethasone dipropionate: 160 mcg twice a day (320 mcg per day total)"
11017945|NCT01143038|BG000|Baseline|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
11017946|NCT01143038|FG000|Participant Flow|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
11148377|NCT01863680|OG000|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
11148378|NCT01863680|EG000|Reported Event|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
11148379|NCT01863732|BG000|Baseline|Secukinumab (AIN457) 75mg Group 1|AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
11148380|NCT01863732|BG001|Baseline|Secukinumab (AIN457) 150mg Group 2|AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
11148381|NCT01863732|BG002|Baseline|Pbo in Core Then AIN457 75mg Group 1|Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
11148382|NCT01863732|BG003|Baseline|Pbo in Core Then AIN457 150mg Group 2|Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
11148383|NCT01863732|BG004|Baseline|Total|Total of all reporting groups
11148384|NCT01863732|FG000|Participant Flow|Secukinumab (AIN457) 75mg Group 1|AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
11148385|NCT01863732|FG001|Participant Flow|Secukinumab (AIN457) 150mg Group 2|AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
11148386|NCT01863732|FG002|Participant Flow|Pbo in Core Then AIN457 75mg Group 1|Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
11148387|NCT01863732|FG003|Participant Flow|Pbo in Core Then AIN457 150mg Group 2|Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
11148388|NCT01863732|OG000|Outcome|Secukinumab (AIN457) 75mg Group 1|AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
11148389|NCT01863732|OG001|Outcome|Secukinumab (AIN457) 150mg Group 2|AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
11148390|NCT01863732|OG002|Outcome|Pbo in Core Then AIN457 75mg Group 1|Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
11148391|NCT01863732|OG003|Outcome|Pbo in Core Then AIN457 150mg Group 2|Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
11148392|NCT01863732|EG000|Reported Event|Any Secukinumab (AIN457) 75 mg|Any Secukinumab (AIN457) 75 mg safety in Core Study CAIN457F2305 and this extension study.
11148393|NCT01863732|EG001|Reported Event|Any Secukinumab (AIN457) 150 mg|Any Secukinumab (AIN457) 150 mgsafety in Core Study CAIN457F2305 and this extension study
11148394|NCT01863732|EG002|Reported Event|Placebo|Placebo in Core study CAIN457F2305E1
11148395|NCT01863758|BG000|Baseline|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
11148396|NCT01863758|FG000|Participant Flow|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
11148397|NCT01863758|OG000|Outcome|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
11148398|NCT01863758|EG000|Reported Event|Human-cl rhFVIII|All subject who received at least one dose of intravenous Human-cl rhFVIII (human cell line recombinant Factor VIII).
11148399|NCT01863771|BG000|Baseline|All Participants|Participants who received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC) in the induction phase.
11148400|NCT01863771|FG000|Participant Flow|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
11017947|NCT01143038|OG000|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
11017948|NCT01143038|EG000|Reported Event|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
11017949|NCT01143051|BG000|Baseline|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
11017950|NCT01143051|BG001|Baseline|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
11017951|NCT01143051|BG002|Baseline|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
11017952|NCT01143051|BG003|Baseline|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
11017953|NCT01143051|BG004|Baseline|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
11017954|NCT01143051|BG005|Baseline|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
11017955|NCT01143051|BG006|Baseline|Total|Total of all reporting groups
11017956|NCT01143051|FG000|Participant Flow|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
11017957|NCT01143051|FG001|Participant Flow|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
10887300|NCT00499655|OG001|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
11017958|NCT01143051|FG002|Participant Flow|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
11148401|NCT01863771|FG001|Participant Flow|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
11148402|NCT01863771|FG002|Participant Flow|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
11017959|NCT01143051|FG003|Participant Flow|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
11017960|NCT01143051|FG004|Participant Flow|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
11017961|NCT01143051|FG005|Participant Flow|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
11017962|NCT01143051|OG000|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
11017963|NCT01143051|OG001|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
11017964|NCT01143051|OG002|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
11017965|NCT01143051|OG002|Outcome|Treatment C|Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
11017966|NCT01143051|OG000|Outcome|Randomized Subjects|Subjects who have taken any amount of study drug treatment.
11017967|NCT01143051|EG000|Reported Event|Treatment T1|"T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation~epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations"
11017968|NCT01143051|EG001|Reported Event|Treatment T2|"HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation~epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations"
11017969|NCT01143051|EG002|Reported Event|Treatment C|"Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.~epinephrine inhalation aerosol : Single dose 220 mcg/inhalation, 10 inhalations"
11017970|NCT01143077|BG000|Baseline|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
11017971|NCT01143077|BG001|Baseline|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
11017972|NCT01143077|BG002|Baseline|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
11017973|NCT01143077|BG003|Baseline|Total|Total of all reporting groups
11017974|NCT01143077|FG000|Participant Flow|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
11017975|NCT01143077|FG001|Participant Flow|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
11017976|NCT01143077|FG002|Participant Flow|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
11017977|NCT01143077|OG000|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
11017978|NCT01143077|OG001|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
11017979|NCT01143077|OG002|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
11017980|NCT01143077|EG000|Reported Event|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
11017981|NCT01143077|EG001|Reported Event|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
11017982|NCT01143077|EG002|Reported Event|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
11017983|NCT01143090|BG000|Baseline|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
11017984|NCT01143090|FG000|Participant Flow|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.
11017985|NCT01143090|OG000|Outcome|Lurasidone Overall|
11017986|NCT01143090|EG000|Reported Event|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
11017987|NCT01143142|BG000|Baseline|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
11148403|NCT01863771|FG003|Participant Flow|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 weeks through Week 52.
11017988|NCT01143142|BG001|Baseline|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
11017989|NCT01143142|BG002|Baseline|Total|Total of all reporting groups
11017990|NCT01143142|FG000|Participant Flow|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
11017991|NCT01143142|FG001|Participant Flow|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
11017992|NCT01143142|OG000|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
11017993|NCT01143142|OG001|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
11017994|NCT01143142|EG000|Reported Event|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
11017995|NCT01143142|EG001|Reported Event|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
11017996|NCT01143181|BG000|Baseline|BCV (≤4 mg/kg/Week)|Pediatric subjects (≤12 years) who received BCV once or twice weekly.
11017997|NCT01143181|BG001|Baseline|BCV (>4 mg/kg/Week)|Pediatric subjects (≤12 years) who received BCV once or twice weekly.
11017998|NCT01143181|BG002|Baseline|BCV (≤200 mg/Week)|Adult/adolescent subjects (≥13 years) who received BCV once or twice weekly.
11017999|NCT01143181|BG003|Baseline|BCV (>200 mg/Week)|Adult/adolescent subjects (≥13 years) who received BCV once or twice weekly.
11018000|NCT01143181|BG004|Baseline|Total|Total of all reporting groups
11018001|NCT01143181|FG000|Participant Flow|BCV (≤4 mg/kg/Week)|Pediatric subjects (≤12 years) who received BCV once or twice weekly.
11018002|NCT01143181|FG001|Participant Flow|BCV (>4 mg/kg/Week)|Pediatric subjects (≤12 years) who received BCV once or twice weekly.
11018003|NCT01143181|FG002|Participant Flow|BCV (≤200 mg/Week)|Adult/adolescent subjects (≥13 years) who received BCV once or twice weekly.
10887301|NCT00499655|OG001|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg oforal erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
11018004|NCT01143181|FG003|Participant Flow|BCV (>200 mg/Week)|Adult/adolescent subjects (≥13 years) who received BCV once or twice weekly.
11018005|NCT01143181|OG000|Outcome|BCV (≤4 mg/kg/Week)|Pediatric subjects (≤12 years) who received BCV once or twice weekly.
11018006|NCT01143181|OG001|Outcome|BCV (>4 mg/kg/Week)|Pediatric subjects (≤12 years) who received BCV once or twice weekly.
11148404|NCT01863771|OG000|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
11341278|NCT03680105|EG002|Reported Event|Part 1; Cohort 2; RJX|Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX on Day 1.
11018007|NCT01143181|OG002|Outcome|BCV (≤200 mg/Week)|Adult/adolescent subjects (≥13 years) who received BCV once or twice weekly.
11018008|NCT01143181|OG003|Outcome|BCV (>200 mg/Week)|Adult/adolescent subjects (≥13 years) who received BCV once or twice weekly.
11018009|NCT01143181|EG000|Reported Event|BCV (≤4 mg/kg/Week)|Pediatric subjects (≤12 years) who received BCV once or twice weekly.
11018010|NCT01143181|EG001|Reported Event|BCV (>4 mg/kg/Week)|Pediatric subjects (≤12 years) who received BCV once or twice weekly.
11018011|NCT01143181|EG002|Reported Event|BCV (≤200 mg/Week)|Adult/adolescent subjects (≥13 years) who received BCV once or twice weekly.
11018012|NCT01143181|EG003|Reported Event|BCV (>200 mg/Week)|Adult/adolescent subjects (≥13 years) who received BCV once or twice weekly.
11018013|NCT01143207|BG000|Baseline|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
11018014|NCT01143207|FG000|Participant Flow|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
11018015|NCT01143207|OG000|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
11018016|NCT01143207|EG000|Reported Event|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
11018017|NCT01143259|BG000|Baseline|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
11018018|NCT01143259|BG001|Baseline|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
11018019|NCT01143259|BG002|Baseline|Total|Total of all reporting groups
11018020|NCT01143259|FG000|Participant Flow|300 mg Polyethylene|Control Group : The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
11018021|NCT01143259|FG001|Participant Flow|Alvimopan|Treatment Group : The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
11018022|NCT01143259|OG000|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
11018023|NCT01143259|OG001|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
11018024|NCT01143259|EG000|Reported Event|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
11018025|NCT01143259|EG001|Reported Event|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
11018026|NCT01143272|BG000|Baseline|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
11018027|NCT01143272|BG001|Baseline|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
11018028|NCT01143272|BG002|Baseline|Total|Total of all reporting groups
11018029|NCT01143272|FG000|Participant Flow|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
11018030|NCT01143272|FG001|Participant Flow|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
11018031|NCT01143272|OG000|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
11018032|NCT01143272|OG001|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
11018033|NCT01143272|EG000|Reported Event|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
11018034|NCT01143272|EG001|Reported Event|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
11018035|NCT01143324|BG000|Baseline|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
11018036|NCT01143324|FG000|Participant Flow|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
11018037|NCT01143324|OG000|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
11018038|NCT01143324|EG000|Reported Event|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
11018039|NCT01143337|BG000|Baseline|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
11148405|NCT01863771|OG001|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
11018040|NCT01143337|BG001|Baseline|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
11018041|NCT01143337|BG002|Baseline|Total|Total of all reporting groups
11018042|NCT01143337|FG000|Participant Flow|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
11018043|NCT01143337|FG001|Participant Flow|MP-435 100mg BID|MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
11018044|NCT01143337|FG002|Participant Flow|MP-435 400mg BID|MP-435 400mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
11018045|NCT01143337|OG000|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
11018046|NCT01143337|OG001|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
11018047|NCT01143337|EG000|Reported Event|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
11018048|NCT01143337|EG001|Reported Event|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
11018049|NCT01143389|BG000|Baseline|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
11018050|NCT01143389|BG001|Baseline|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
11018051|NCT01143389|BG002|Baseline|Total|Total of all reporting groups
11018052|NCT01143389|FG000|Participant Flow|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
11018053|NCT01143389|FG001|Participant Flow|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
11018054|NCT01143389|OG000|Outcome|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
11018055|NCT01143389|OG001|Outcome|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
11018056|NCT01143389|EG000|Reported Event|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
11018057|NCT01143389|EG001|Reported Event|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
11018058|NCT01143402|BG000|Baseline|Arm I (Temozolomide)|Randomized to Temozolomide
11018059|NCT01143402|BG001|Baseline|Arm II (Selumetinib)|Randomized to Selumetinib
11018060|NCT01143402|BG002|Baseline|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
11018061|NCT01143402|BG003|Baseline|Total|Total of all reporting groups
11018062|NCT01143402|FG000|Participant Flow|Arm I (Temozolomide)|Randomized to Temozolomide
11018063|NCT01143402|FG001|Participant Flow|Arm II (Selumetinib)|Randomized to Selumetinib
11018064|NCT01143402|FG002|Participant Flow|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
11018065|NCT01143402|OG000|Outcome|Arm I (Temozolomide)|Randomized to Temozolomide
11018066|NCT01143402|OG001|Outcome|Arm II (Selumetinib)|Randomized to Selumetinib
11018067|NCT01143402|EG000|Reported Event|Arm I (Temozolomide)|Randomized to Temozolomide
11018068|NCT01143402|EG001|Reported Event|Arm II (Selumetinib)|Randomized to Selumetinib
11018069|NCT01143402|EG002|Reported Event|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
11018070|NCT01143610|BG000|Baseline|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
11018071|NCT01143610|BG001|Baseline|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
11018072|NCT01143610|BG002|Baseline|Total|Total of all reporting groups
11018073|NCT01143610|FG000|Participant Flow|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
11018074|NCT01143610|FG001|Participant Flow|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
11018075|NCT01143610|OG000|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
11018076|NCT01143610|OG001|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
11018077|NCT01143610|EG000|Reported Event|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
11018078|NCT01143610|EG001|Reported Event|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
11018079|NCT01143636|BG000|Baseline|Active tDCS - Pelvic Pain|Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
11018080|NCT01143636|BG001|Baseline|Sham tDCS - Pelvic Pain|Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
11018081|NCT01143636|BG002|Baseline|Active tDCS&Sham tDCS - Healthy Controls|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
11018082|NCT01143636|BG003|Baseline|Total|Total of all reporting groups
11018083|NCT01143636|FG000|Participant Flow|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
11018084|NCT01143636|FG001|Participant Flow|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
11018085|NCT01143636|FG002|Participant Flow|Healthy Controls: Active tDCS/Sham tDCS|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
11018086|NCT01143636|FG003|Participant Flow|Healthy Subjects: Sham tDCS/Active tDCS|Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
11018087|NCT01143636|OG000|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
11018088|NCT01143636|OG001|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
11018089|NCT01143636|OG000|Outcome|Healthy Controls: Active tDCS|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
11018090|NCT01143636|OG001|Outcome|Healthy Subjects: Sham tDCS|Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
11148406|NCT01863771|EG000|Reported Event|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
11018091|NCT01143636|EG000|Reported Event|SHAM tDCS - Pelvic Pain Patients|"SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.~For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
11018092|NCT01143636|EG001|Reported Event|ACTIVE tDCS - Pelvic Pain Patients|"ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
11018093|NCT01143636|EG002|Reported Event|SHAM tDCS - Healthy|"SHAM tDCS: Subjects will receive a single session of sham tDCS. The anode electrode will be placed on the primary motor cortex.~For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
11018094|NCT01143636|EG003|Reported Event|ACTIVE tDCS - Sham|"ACTIVE tDCS: Subjects will receive a single session of active tDCS. The anode electrode will be placed on the primary motor cortex.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
11018095|NCT01143649|BG000|Baseline|tDCS + CIMT - Stroke|"Participants received active tDCS over the primary motor cortex (M1). We used the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects were stimulated at 1 mA for 40 minutes."
11018096|NCT01143649|BG001|Baseline|Sham tDCS + CIMT - Stroke|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
11018097|NCT01143649|BG002|Baseline|tDCS Active + CIMT - Healthy|Participants received active (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
11018098|NCT01143649|BG003|Baseline|Sham tDCS + CIMT - Healthy|Participants received sham tDCS (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
11018099|NCT01143649|BG004|Baseline|tACS Active&Sham - Healthy|active or sham 15Hz-tACS over of the primary motor cortex (M1) bilaterally.
11018100|NCT01143649|BG005|Baseline|Total|Total of all reporting groups
11018101|NCT01143649|FG000|Participant Flow|tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
11018102|NCT01143649|FG001|Participant Flow|Sham tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Sham stimulation consists of 30secondes of stimulation at the beginning of the 40minutes treatment."
11018103|NCT01143649|FG002|Participant Flow|Healthy Participants: Active tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA."
11018104|NCT01143649|FG003|Participant Flow|Healthy Participants: Sham tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS."
11018105|NCT01143649|FG004|Participant Flow|Healthy Participants - Active tACS, Then Sham|Subjects will receive 20 min of active then sham tACS over the primary motor cortex in a randomized order.
11018106|NCT01143649|FG005|Participant Flow|Healthy Participants - Sham tACS, Then Active|Subjects will receive 20 min of sham and then tACS over the primary motor cortex in a randomized order.
11018107|NCT01143649|OG000|Outcome|tDCS + CIMT|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
11018108|NCT01143649|OG001|Outcome|Sham tDCS + CIMT|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
11018109|NCT01143649|OG000|Outcome|Healthy Participants: Active tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA."
11018110|NCT01143649|OG001|Outcome|Healthy Participants: Sham tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS."
11018111|NCT01143649|OG000|Outcome|Healthy Participants - Active tACS|Subjects will receive 20 min of active tACS
10887302|NCT00499655|EG000|Reported Event|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
11018112|NCT01143649|OG001|Outcome|Healthy Participants - Sham tACS|Subjects will receive 20 min of sham tACS
11148407|NCT01863771|EG001|Reported Event|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
11018113|NCT01143649|EG000|Reported Event|tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
11018114|NCT01143649|EG001|Reported Event|Sham tDCS + CIMT - Stroke|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
11018115|NCT01143649|EG002|Reported Event|Active tDCS + CIMT - Healthy|subjects will undergo 40 minutes of tDCS at 1mA.
11018116|NCT01143649|EG003|Reported Event|Sham tDCS + CIMT - Healthy|subjects will undergo 40 minutes of sham tDCS.
11018117|NCT01143649|EG004|Reported Event|Active tACS - Healthy|Subjects will undergo 20 minutes of active tACS.
11018118|NCT01143649|EG005|Reported Event|Sham tACS - Healthy|Subjects will undergo 20 minutes of sham tACS.
10886226|NCT00492856|BG000|Baseline|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). If CRm, patients randomized to either (1) maintenance: ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle), or (2) observation. If CR or CRi, but not CRm, patients received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
11018119|NCT01143688|BG000|Baseline|Overall Study|
11018120|NCT01143688|FG000|Participant Flow|All Study Participants|Each study participant was randomized to a specific random sequence of interventions for visits 1-4 (e.g. first inhaled bronchodilator, then inhaled placebo, then sham acupuncture, then no intervention administered 3-7 days apart, or first sham acupuncture, then inhaled bronchodilator, then no intervention, then inhaled placebo administered 3-7 days apart, or any other combination of these four interventions in any order). This process was repeated for visits 5-8 and again for visits 9-12.
11018121|NCT01143688|OG000|Outcome|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.~Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
11018122|NCT01143688|OG001|Outcome|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
11018123|NCT01143688|OG002|Outcome|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
11018124|NCT01143688|OG003|Outcome|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.~Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
11018125|NCT01143688|EG000|Reported Event|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.~Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
11018126|NCT01143688|EG001|Reported Event|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
11018127|NCT01143688|EG002|Reported Event|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
11018128|NCT01143688|EG003|Reported Event|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.~Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
11018129|NCT01143701|BG000|Baseline|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
11018130|NCT01143701|BG001|Baseline|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
11018131|NCT01143701|BG002|Baseline|Total|Total of all reporting groups
11018132|NCT01143701|FG000|Participant Flow|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics ADHD guidelines."
11018133|NCT01143701|FG001|Participant Flow|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
11018134|NCT01143701|OG000|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
11018135|NCT01143701|OG001|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
11018136|NCT01143701|EG000|Reported Event|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
11018137|NCT01143701|EG001|Reported Event|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
11018138|NCT01143714|BG000|Baseline|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
11018139|NCT01143714|BG001|Baseline|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
11018140|NCT01143714|BG002|Baseline|Total|Total of all reporting groups
11018141|NCT01143714|FG000|Participant Flow|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
11018142|NCT01143714|FG001|Participant Flow|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
11018143|NCT01143714|OG000|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
11018144|NCT01143714|OG001|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
11018145|NCT01143714|EG000|Reported Event|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
11018146|NCT01143714|EG001|Reported Event|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
11018147|NCT01143727|BG000|Baseline|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
11018148|NCT01143727|BG001|Baseline|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
11018149|NCT01143727|BG002|Baseline|Total|Total of all reporting groups
11018150|NCT01143727|FG000|Participant Flow|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
11018151|NCT01143727|FG001|Participant Flow|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
11018152|NCT01143727|OG000|Outcome|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
11018153|NCT01143727|OG001|Outcome|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
11018154|NCT01143727|EG000|Reported Event|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
11018155|NCT01143727|EG001|Reported Event|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
11018156|NCT01143766|BG000|Baseline|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
11018157|NCT01143766|BG001|Baseline|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
11018158|NCT01143766|BG002|Baseline|Total|Total of all reporting groups
11018159|NCT01143766|FG000|Participant Flow|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
11018160|NCT01143766|FG001|Participant Flow|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
11018161|NCT01143766|OG000|Outcome|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
11018162|NCT01143766|OG001|Outcome|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
11018163|NCT01143766|OG000|Outcome|Standard Sedation|"Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.~Standard sedation regimen: Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care."
11018164|NCT01143766|OG001|Outcome|Gapabentin|"Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.~Gabapentin: gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure"
11018165|NCT01143766|EG000|Reported Event|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
11018166|NCT01143766|EG001|Reported Event|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
11018167|NCT01143792|BG000|Baseline|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
11018168|NCT01143792|BG001|Baseline|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
11018169|NCT01143792|BG002|Baseline|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
11018170|NCT01143792|BG003|Baseline|Total|Total of all reporting groups
11018171|NCT01143792|FG000|Participant Flow|CRA + HIV Prevention|Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
11018172|NCT01143792|FG001|Participant Flow|MET + HIV Prevention|Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions.
11018173|NCT01143792|FG002|Participant Flow|Case Management + HIV Prevention|Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
11018174|NCT01143792|OG000|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
11018175|NCT01143792|OG001|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
11018176|NCT01143792|OG002|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
11018177|NCT01143792|OG000|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
11018178|NCT01143792|OG001|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
11018179|NCT01143792|OG002|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
11018180|NCT01143792|OG001|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
11018181|NCT01143792|OG002|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
11018182|NCT01143792|OG000|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
11018183|NCT01143792|OG001|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
11018184|NCT01143792|OG002|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
11018185|NCT01143792|OG000|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
11018186|NCT01143792|OG001|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
11018187|NCT01143792|OG002|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
11018188|NCT01143792|EG000|Reported Event|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
11018189|NCT01143792|EG001|Reported Event|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
11018190|NCT01143792|EG002|Reported Event|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
11018191|NCT01143818|BG000|Baseline|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
11018192|NCT01143818|FG000|Participant Flow|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
11018193|NCT01143818|OG000|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
11018194|NCT01143818|EG000|Reported Event|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
11018195|NCT01143870|BG000|Baseline|Control|Received information on diabetes control using the standard hemoglobin A1c value
11018196|NCT01143870|BG001|Baseline|Letter Grades|Received information on diabetes control translated into a letter grade, ranging from A-F
11018197|NCT01143870|BG002|Baseline|Faces|Received information on diabetes control translated into a emoticon, ranging from smiling to crying
11018198|NCT01143870|BG003|Baseline|Total|Total of all reporting groups
11018199|NCT01143870|FG000|Participant Flow|Control|Received information on diabetes control using the standard hemoglobin A1c value
11018200|NCT01143870|FG001|Participant Flow|Letter Grades|Received information on diabetes control translated into a letter grade, ranging from A-F
11018201|NCT01143870|FG002|Participant Flow|Faces|Received information on diabetes control translated into a emoticon, ranging from smiling to crying
11018202|NCT01143870|OG000|Outcome|Control|Received information on diabetes control using the standard hemoglobin A1c value
11018203|NCT01143870|OG001|Outcome|Letter Grades|Received information on diabetes control translated into a letter grade, ranging from A-F
11018204|NCT01143870|OG002|Outcome|Faces|Received information on diabetes control translated into a emoticon, ranging from smiling to crying
11018205|NCT01143870|EG000|Reported Event|Control|Received information on diabetes control using the standard hemoglobin A1c value
11018206|NCT01143870|EG001|Reported Event|Letter Grades|
11018207|NCT01143870|EG002|Reported Event|Faces|
11018208|NCT01143883|BG000|Baseline|Silverlon Dressing|55
11018209|NCT01143883|BG001|Baseline|Standard of Care Dressing|55
11018210|NCT01143883|BG002|Baseline|Total|Total of all reporting groups
11018211|NCT01143883|FG000|Participant Flow|Silverlon Dressing|The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.
11018212|NCT01143883|FG001|Participant Flow|Standard of Care Dressing|The standard plain gauze is used to dress the wound postoperatively
11018213|NCT01143883|OG000|Outcome|Silverlon Dressing|55
11018214|NCT01143883|OG001|Outcome|Standard of Care Dressing|55
11018215|NCT01143883|EG000|Reported Event|Silverlon Dressing|55
11018216|NCT01143883|EG001|Reported Event|Standard of Care Dressing|55
11018217|NCT01143896|BG000|Baseline|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
11018218|NCT01143896|BG001|Baseline|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
11018219|NCT01143896|BG002|Baseline|Total|Total of all reporting groups
11018220|NCT01143896|FG000|Participant Flow|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
11018221|NCT01143896|FG001|Participant Flow|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
11018222|NCT01143896|OG000|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
11018223|NCT01143896|OG001|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
11148408|NCT01863771|EG002|Reported Event|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
11148409|NCT01863771|EG003|Reported Event|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 week through Week 52.
11148410|NCT01863849|BG000|Baseline|Age Group 1: Adults (18-59 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11148411|NCT01863849|BG001|Baseline|Age Group 2: Elderly (>60 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11148412|NCT01863849|BG002|Baseline|Total|Total of all reporting groups
11148413|NCT01863849|FG000|Participant Flow|Age Group 1: Adults (18-59 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.~Vaccination with Fluval AB suspension for injection: Single intramuscular injection with Fluval AB suspension for injection in both age groups"
11148414|NCT01863849|FG001|Participant Flow|Age Group 2: Elderly (> 60 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.~Vaccination with Fluval AB suspension for injection: Single intramuscular injection with Fluval AB suspension for injection in both age groups"
11148415|NCT01863849|OG000|Outcome|Age Group 1: Adults (18-59 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11148416|NCT01863849|OG001|Outcome|Age Group 2: Elderly (>60 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11148417|NCT01863849|OG001|Outcome|Age Group 2: Elderly (> 60 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11148418|NCT01863849|EG000|Reported Event|Age Group 1: Adults (18-59 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11148419|NCT01863849|EG001|Reported Event|Age Group 2: Elderly (> 60 Years)|"Intervention: Vaccination with Fluval AB suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11148420|NCT01863953|BG000|Baseline|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
11148421|NCT01863953|BG001|Baseline|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
11148422|NCT01863953|BG002|Baseline|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
11148423|NCT01863953|BG003|Baseline|Total|Total of all reporting groups
11148424|NCT01863953|FG000|Participant Flow|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
11148425|NCT01863953|FG001|Participant Flow|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
11148426|NCT01863953|FG002|Participant Flow|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
11148427|NCT01863953|OG000|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
11148428|NCT01863953|OG001|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
11148429|NCT01863953|OG002|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
11148430|NCT01863953|EG000|Reported Event|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
11148431|NCT01863953|EG001|Reported Event|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
11148432|NCT01863953|EG002|Reported Event|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
11148433|NCT01864005|BG000|Baseline|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
11148434|NCT01864005|BG001|Baseline|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
11148435|NCT01864005|BG002|Baseline|Total|Total of all reporting groups
11148436|NCT01864005|FG000|Participant Flow|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
11148437|NCT01864005|FG001|Participant Flow|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
11148438|NCT01864005|OG000|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
11148439|NCT01864005|OG001|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
11018224|NCT01143896|OG000|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
11018225|NCT01143896|EG000|Reported Event|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
11018226|NCT01143896|EG001|Reported Event|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
11018227|NCT01144026|BG000|Baseline|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
11018228|NCT01144026|BG001|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
11018229|NCT01144026|BG002|Baseline|Total|Total of all reporting groups
11018230|NCT01144026|FG000|Participant Flow|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
11018231|NCT01144026|FG001|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
11018232|NCT01144026|OG000|Outcome|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
11018233|NCT01144026|OG001|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
11018234|NCT01144026|EG000|Reported Event|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
11018235|NCT01144026|EG001|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
11018236|NCT01144052|BG000|Baseline|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
11018237|NCT01144052|BG001|Baseline|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
11018238|NCT01144052|BG002|Baseline|Total|Total of all reporting groups
11018239|NCT01144052|FG000|Participant Flow|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
11018240|NCT01144052|FG001|Participant Flow|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
11018241|NCT01144052|OG000|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
11018242|NCT01144052|OG001|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
11018243|NCT01144052|OG000|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.~Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions."
11018244|NCT01144052|OG001|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day~interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
11018245|NCT01144052|EG000|Reported Event|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
11018246|NCT01144052|EG001|Reported Event|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
11018247|NCT01144143|BG000|Baseline|Infliximab|Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
11018248|NCT01144143|BG001|Baseline|Salt Water|Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
11018249|NCT01144143|BG002|Baseline|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
11018250|NCT01144143|BG003|Baseline|Total|Total of all reporting groups
11018251|NCT01144143|FG000|Participant Flow|Infliximab|Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
11018252|NCT01144143|FG001|Participant Flow|Salt Water|Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
11018253|NCT01144143|FG002|Participant Flow|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
11018254|NCT01144143|OG000|Outcome|Infliximab|Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
11018255|NCT01144143|OG001|Outcome|Salt Water|Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
11018256|NCT01144143|OG002|Outcome|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
11018257|NCT01144143|OG001|Outcome|Salt Water|Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needlePlacebo: the placebo will be injected into the joint through a needle
11018258|NCT01144143|OG000|Outcome|Infliximab|Infliximab: the study drug will be injected into the joint through a needle
11018259|NCT01144143|OG001|Outcome|Normal Saline|Placebo: the placebo will be injected into the joint through a needle
11018260|NCT01144143|OG002|Outcome|Methylprednisolone Acetate|Standard of Care: Methylprednisolone acetate: Methylprednisolone acetate will be injected into the joint through a needle
11018261|NCT01144143|EG000|Reported Event|Infliximab|Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
11018262|NCT01144143|EG001|Reported Event|Salt Water|Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
11018263|NCT01144143|EG002|Reported Event|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
11018264|NCT01144182|BG000|Baseline|Current Best Practice (CBP)|Current best practice (CBP) receives the current treatment for patients discharged with heart failure
11018265|NCT01144182|BG001|Baseline|Comprehensive Quality Improvement Program (QIP)|Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
11018266|NCT01144182|BG002|Baseline|Total|Total of all reporting groups
11018267|NCT01144182|FG000|Participant Flow|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
11018268|NCT01144182|FG001|Participant Flow|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
11018269|NCT01144182|OG000|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
11018270|NCT01144182|OG001|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
11018271|NCT01144182|OG001|Outcome|Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
11018272|NCT01144182|EG000|Reported Event|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
11018273|NCT01144182|EG001|Reported Event|Quality Improvement Program (QIP)|"Quality improvement program (QIP)~The comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
11018274|NCT01144286|BG000|Baseline|Placebo|placebo pessary, single dose
11018275|NCT01144286|BG001|Baseline|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
11018276|NCT01144286|BG002|Baseline|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
11018277|NCT01144286|BG003|Baseline|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
11018278|NCT01144286|BG004|Baseline|Total|Total of all reporting groups
11018279|NCT01144286|FG000|Participant Flow|Placebo|placebo pessary, single dose
11018280|NCT01144286|FG001|Participant Flow|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
11018281|NCT01144286|FG002|Participant Flow|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
11018282|NCT01144286|FG003|Participant Flow|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
11018283|NCT01144286|OG000|Outcome|Placebo|placebo pessary, single dose
11018284|NCT01144286|OG001|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
11018285|NCT01144286|OG002|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
11018286|NCT01144286|OG003|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
11018287|NCT01144286|EG000|Reported Event|Placebo|placebo pessary, single dose
11018288|NCT01144286|EG001|Reported Event|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
11018289|NCT01144286|EG002|Reported Event|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
11018290|NCT01144286|EG003|Reported Event|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
11018291|NCT01144299|BG000|Baseline|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
11018292|NCT01144299|BG001|Baseline|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
11018293|NCT01144299|BG002|Baseline|Total|Total of all reporting groups
11018294|NCT01144299|FG000|Participant Flow|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
11018295|NCT01144299|FG001|Participant Flow|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
11018296|NCT01144299|OG000|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
11018297|NCT01144299|OG001|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
11018298|NCT01144299|EG000|Reported Event|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
11018299|NCT01144299|EG001|Reported Event|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
11018300|NCT01144338|BG000|Baseline|Placebo|Matching placebo subcutaneous injections
11018301|NCT01144338|BG001|Baseline|Exenatide Once Weekly|Exenatide 2mg once weekly subcutaneous injections
11018302|NCT01144338|BG002|Baseline|Total|Total of all reporting groups
11018303|NCT01144338|FG000|Participant Flow|Placebo|Matching placebo subcutaneous injections
11018304|NCT01144338|FG001|Participant Flow|Exenatide Once Weekly|Exenatide 2mg once weekly subcutaneous injections
11018305|NCT01144338|OG000|Outcome|Placebo|Matching placebo subcutaneous injections
11018306|NCT01144338|OG001|Outcome|Exenatide Once Weekly|Exenatide 2mg once weekly subcutaneous injections
11018307|NCT01144338|EG000|Reported Event|Placebo|Matching placebo subcutaneous injections
11018308|NCT01144338|EG001|Reported Event|Exenatide Once Weekly|Exenatide 2mg once weekly subcutaneous injections
11018309|NCT01144364|BG000|Baseline|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
11018310|NCT01144364|BG001|Baseline|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
11018311|NCT01144364|BG002|Baseline|Total|Total of all reporting groups
11018312|NCT01144364|FG000|Participant Flow|Induction Phase-Immunochemotherapy Rituximab-FND (R-FND)|Cycles 1 to 4: Participants received rituximab: 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1*, fludarabine (F): 25 mg/m^2 IV on Days 2-4*, mitoxantrone (N): 10 mg/m^2 IV on Day 2*, dexamethasone (D) 10 mg IV (total dose) on Days 2-4*. Cycles were repeated every 28 days for a total of 4 cycles. *In Cycle 1, rituximab was given on Day 8 in order to avoid tumour lysis syndrome. Consequently, in Cycle 1, fludarabine and dexamethasone were given on Days 1, 2, and 3. Mitoxantrone was given on Day 1.
11018313|NCT01144364|FG001|Participant Flow|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
11018314|NCT01144364|FG002|Participant Flow|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
11148440|NCT01864005|EG000|Reported Event|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
11341279|NCT03680105|EG003|Reported Event|Part 1; Cohort 3; RJX|Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX on Day 1.
11018315|NCT01144364|OG000|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
11018316|NCT01144364|OG001|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
11018317|NCT01144364|OG000|Outcome|Rituximab Induction|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no therapy (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
11018318|NCT01144364|OG000|Outcome|Rituximab Induction, Rituximab Maintenance|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
11018319|NCT01144364|OG000|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no treatment (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
11018320|NCT01144364|EG000|Reported Event|Rituximab Induction (Induction Phase Only)|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).
11018321|NCT01144364|EG001|Reported Event|Rituximab Induction, Rituximab Maintenance (Follow-up Phase)|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
11018322|NCT01144364|EG002|Reported Event|Rituximab Induction, Observation Maintenance (Follow-up Phase)|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
11018323|NCT01144377|BG000|Baseline|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
11018324|NCT01144377|BG001|Baseline|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018325|NCT01144377|BG002|Baseline|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018326|NCT01144377|BG003|Baseline|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
11018327|NCT01144377|BG004|Baseline|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018328|NCT01144377|BG005|Baseline|Total|Total of all reporting groups
11018329|NCT01144377|FG000|Participant Flow|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
11018330|NCT01144377|FG001|Participant Flow|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
11018331|NCT01144377|FG002|Participant Flow|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
11148441|NCT01864005|EG001|Reported Event|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
11018332|NCT01144377|FG003|Participant Flow|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
11018333|NCT01144377|FG004|Participant Flow|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period (for an additional 40 weeks for a total of 52 weeks follow-up for the main study participants only).
11018334|NCT01144377|OG000|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
11018335|NCT01144377|OG001|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018336|NCT01144377|OG002|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018337|NCT01144377|OG003|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
11018338|NCT01144377|OG004|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018339|NCT01144377|OG000|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
11018340|NCT01144377|OG003|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
11018341|NCT01144377|EG000|Reported Event|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
11018342|NCT01144377|EG001|Reported Event|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018343|NCT01144377|EG002|Reported Event|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018344|NCT01144377|EG003|Reported Event|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
11018345|NCT01144377|EG004|Reported Event|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
11018346|NCT01144403|BG000|Baseline|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
11148442|NCT01864148|BG000|Baseline|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11148443|NCT01864148|BG001|Baseline|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018347|NCT01144403|FG000|Participant Flow|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
11018348|NCT01144403|OG000|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~cyclophosphamide: as prescribed, 6 cycles~fludarabine: as prescribed, 6 cycles~mitoxantrone: as prescribed, 6 cycles~rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles"
11018349|NCT01144403|OG000|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
11018350|NCT01144403|EG000|Reported Event|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
11018351|NCT01144442|BG000|Baseline|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
11018352|NCT01144442|FG000|Participant Flow|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
11018353|NCT01144442|OG000|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
11018354|NCT01144442|EG000|Reported Event|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
11018355|NCT01144455|BG000|Baseline|Gemcitabine|"Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle."
11018356|NCT01144455|BG001|Baseline|240 mg/m2 TH-302 + Gemcitabine|"TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
11018357|NCT01144455|BG002|Baseline|340 mg/m2 TH-302 + Gemcitabine|"TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
11018358|NCT01144455|BG003|Baseline|Total|Total of all reporting groups
11018359|NCT01144455|FG000|Participant Flow|Gemcitabine|"Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle."
11018360|NCT01144455|FG001|Participant Flow|240 mg/m2 TH-302 + Gemcitabine|"TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
11018361|NCT01144455|FG002|Participant Flow|340 mg/m2 TH-302 + Gemcitabine|"TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
11018362|NCT01144455|OG000|Outcome|Gemcitabine|"Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle."
11018363|NCT01144455|OG001|Outcome|240 mg/m2 TH-302 + Gemcitabine|"TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
11018364|NCT01144455|OG002|Outcome|340 mg/m2 TH-302 + Gemcitabine|"TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
11018365|NCT01144455|EG000|Reported Event|Gemcitabine|"Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle."
11148444|NCT01864148|BG002|Baseline|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11148445|NCT01864148|BG003|Baseline|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018366|NCT01144455|EG001|Reported Event|240 mg/m2 TH-302 + Gemcitabine|"TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
11018367|NCT01144455|EG002|Reported Event|340 mg/m2 TH-302 + Gemcitabine|"TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
11018368|NCT01144494|BG000|Baseline|All Study Participants|participants were randomized to receive both IOP lowering drug and lubricating drops in a randomized order
11018369|NCT01144494|FG000|Participant Flow|IOP Lowering Drug Then Art Tears|"Eyedrops for lowering intraocular pressure~Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.~Lubricated eye drops~Artificial tears: Lubricating drops added three times a day for six weeks"
11018370|NCT01144494|FG001|Participant Flow|Artificial Tears Then IOP Lowering Drug|"Lubricated eye drops~Artificial tears: Lubricating drops added three times a day for six weeks~Eyedrops for lowering intraocular pressure~Brimonidine: One drop of brimonidine in each eye three times a day for six weeks."
11018371|NCT01144494|OG000|Outcome|Intraocular Pressure Lowering Drug|"Eyedrops for lowering intraocular pressure~Brimonidine: One drop of brimonidine in each eye three times a day for six weeks."
11018372|NCT01144494|OG001|Outcome|Artificial Tears|"Lubricated eye drops~Artificial tears: Lubricating drops added three times a day for six weeks"
11018373|NCT01144494|OG000|Outcome|IOP Lowering Drug|"Eyedrops for lowering intraocular pressure~Brimonidine: One drop of brimonidine in each eye three times a day for six weeks."
11018374|NCT01144494|OG000|Outcome|IOP Lowering Drug (Day)|"Eyedrops for lowering intraocular pressure~Brimonidine: One drop of brimonidine in each eye three times a day for six weeks."
11018375|NCT01144494|OG001|Outcome|IOP Lowering Drug (Night)|"Eyedrops for lowering intraocular pressure~Brimonidine: One drop of brimonidine in each eye three times a day for six weeks."
11018376|NCT01144494|OG002|Outcome|Artificial Tears (Day)|"Lubricated eye drops~Artificial tears: Lubricating drops added three times a day for six weeks"
11018377|NCT01144494|OG003|Outcome|Artificial Tears (Night)|"Lubricated eye drops~Artificial tears: Lubricating drops added three times a day for six weeks"
11018378|NCT01144494|EG000|Reported Event|Intraocular Pressure Lowering Drug|"Eyedrops for lowering intraocular pressure~Brimonidine: One drop of brimonidine in each eye three times a day for six weeks."
11018379|NCT01144494|EG001|Reported Event|Artificial Tears|"Lubricated eye drops~Artificial tears: Lubricating drops added three times a day for six weeks"
11018380|NCT01144598|BG000|Baseline|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
11018381|NCT01144598|FG000|Participant Flow|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
11018382|NCT01144598|OG000|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
11018383|NCT01144598|EG000|Reported Event|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
11018384|NCT01144624|BG000|Baseline|Dose Cohort 1|AZD9773 250/50 units/kg IV
11018385|NCT01144624|BG001|Baseline|Dose Cohort 2|AZD9773 500/100 units/kg IV
11018386|NCT01144624|BG002|Baseline|Placebo|Saline
11018387|NCT01144624|BG003|Baseline|Total|Total of all reporting groups
11018388|NCT01144624|FG000|Participant Flow|Dose Cohort 1|AZD9773 250/50 units/kg IV
11018389|NCT01144624|FG001|Participant Flow|Dose Cohort 2|AZD9773 500/100 units/kg IV
11018390|NCT01144624|FG002|Participant Flow|Placebo|Saline
11018391|NCT01144624|OG000|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
11018392|NCT01144624|OG001|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
11018393|NCT01144624|OG002|Outcome|Arm 3 - Placebo|Saline
11018394|NCT01144624|EG000|Reported Event|Dose Cohort 1|AZD9773 250/50 units/kg IV
11018395|NCT01144624|EG001|Reported Event|Dose Cohort 2|AZD9773 500/100 units/kg IV
11018396|NCT01144624|EG002|Reported Event|Placebo|Saline
11018397|NCT01144637|BG000|Baseline|Group 1|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018398|NCT01144637|BG001|Baseline|Group 2|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018399|NCT01144637|BG002|Baseline|Group 3|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018400|NCT01144637|BG003|Baseline|Group 4|"Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)~Placebo: 0.5 ml TBS"
11018401|NCT01144637|BG004|Baseline|Total|Total of all reporting groups
11018402|NCT01144637|FG000|Participant Flow|Group 1|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018403|NCT01144637|FG001|Participant Flow|Group 2|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018404|NCT01144637|FG002|Participant Flow|Group 3|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018405|NCT01144637|FG003|Participant Flow|Group 4|"Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)~Placebo: 0.5 ml TBS"
11018406|NCT01144637|OG000|Outcome|Group 1|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018407|NCT01144637|OG001|Outcome|Group 2|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018408|NCT01144637|OG002|Outcome|Group 3|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018409|NCT01144637|OG003|Outcome|Group 4|"Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)~Placebo: 0.5 ml TBS"
11018410|NCT01144637|EG000|Reported Event|Group 1|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018411|NCT01144637|EG001|Reported Event|Group 2|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018412|NCT01144637|EG002|Reported Event|Group 3|"Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3~IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)"
11018413|NCT01144637|EG003|Reported Event|Group 4|"Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)~Placebo: 0.5 ml TBS"
11018414|NCT01144663|BG000|Baseline|Nimenrix 3 Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
11018415|NCT01144663|BG001|Baseline|Nimenrix 2 Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018416|NCT01144663|BG002|Baseline|Menjugate Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018417|NCT01144663|BG003|Baseline|NeisVac-C Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018418|NCT01144663|BG004|Baseline|Total|Total of all reporting groups
11018419|NCT01144663|FG000|Participant Flow|Nimenrix 3 Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
11018420|NCT01144663|FG001|Participant Flow|Nimenrix 2 Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11148446|NCT01864148|BG004|Baseline|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018421|NCT01144663|FG002|Participant Flow|Menjugate Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11148447|NCT01864148|BG005|Baseline|Total|Total of all reporting groups
11018422|NCT01144663|FG003|Participant Flow|NeisVac-C Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018423|NCT01144663|OG000|Outcome|Nimenrix 3 Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
11018424|NCT01144663|OG001|Outcome|Nimenrix 2 Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11148448|NCT01864148|FG000|Participant Flow|Placebo|"Placebo once every 4 weeks intravenous (IV) infusion up to Week 72.~Avonex once-weekly intramuscular (IM) injection up to Week 84."
11148449|NCT01864148|FG001|Participant Flow|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11148450|NCT01864148|FG002|Participant Flow|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11148451|NCT01864148|FG003|Participant Flow|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018425|NCT01144663|OG002|Outcome|Menjugate Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018426|NCT01144663|OG003|Outcome|NeisVac-C Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018427|NCT01144663|EG000|Reported Event|Nimenrix 3 Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
11018428|NCT01144663|EG001|Reported Event|Nimenrix 2 Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018429|NCT01144663|EG002|Reported Event|Menjugate Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018430|NCT01144663|EG003|Reported Event|NeisVac-C Group|Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
11018431|NCT01144715|BG000|Baseline|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
11018432|NCT01144715|BG001|Baseline|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
11018433|NCT01144715|BG002|Baseline|Total|Total of all reporting groups
11018434|NCT01144715|FG000|Participant Flow|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
11018435|NCT01144715|FG001|Participant Flow|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
11018436|NCT01144715|OG000|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
11018437|NCT01144715|OG001|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
11148452|NCT01864148|FG004|Participant Flow|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018438|NCT01144715|EG000|Reported Event|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
11018439|NCT01144715|EG001|Reported Event|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
11018440|NCT01144949|BG000|Baseline|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
11148453|NCT01864148|OG000|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11148454|NCT01864148|OG001|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11148455|NCT01864148|OG002|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018441|NCT01144949|BG001|Baseline|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
11018442|NCT01144949|BG002|Baseline|Total|Total of all reporting groups
11018443|NCT01144949|FG000|Participant Flow|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
11018444|NCT01144949|FG001|Participant Flow|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
11018445|NCT01144949|OG000|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
11018446|NCT01144949|OG001|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
11018447|NCT01144949|EG000|Reported Event|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
11018448|NCT01144949|EG001|Reported Event|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
11018449|NCT01145001|BG000|Baseline|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
11018450|NCT01145001|BG001|Baseline|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
11018451|NCT01145001|BG002|Baseline|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
11018452|NCT01145001|BG003|Baseline|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
11018453|NCT01145001|BG004|Baseline|Total|Total of all reporting groups
11018454|NCT01145001|FG000|Participant Flow|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
11018455|NCT01145001|FG001|Participant Flow|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
11018456|NCT01145001|FG002|Participant Flow|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
11018457|NCT01145001|FG003|Participant Flow|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
11018458|NCT01145001|OG000|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
11018459|NCT01145001|OG001|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
11018460|NCT01145001|OG002|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
11018461|NCT01145001|OG003|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
11018462|NCT01145001|EG000|Reported Event|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
11018463|NCT01145001|EG001|Reported Event|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
11018464|NCT01145001|EG002|Reported Event|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
11018465|NCT01145001|EG003|Reported Event|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
11018466|NCT01145053|BG000|Baseline|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
11018467|NCT01145053|FG000|Participant Flow|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
11018468|NCT01145053|OG000|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
11018469|NCT01145053|EG000|Reported Event|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
11018470|NCT01145066|BG000|Baseline|Borage and Echium Oil Combination|"borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA~borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA"
11018471|NCT01145066|BG001|Baseline|Fish Oil|"Croda 18:12 fish oil~fish oil: 1.6g/day EPA and 1.08g/day DHA"
11018472|NCT01145066|BG002|Baseline|Corn Oil|corn oil: contains 4.5 g/day linoleic acid
11018473|NCT01145066|BG003|Baseline|Total|Total of all reporting groups
11018474|NCT01145066|FG000|Participant Flow|Borage and Echium Oil Combination|"borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA~borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA"
11018475|NCT01145066|FG001|Participant Flow|Fish Oil|"Croda 18:12 fish oil~fish oil: 1.6g/day EPA and 1.08g/day DHA"
11018476|NCT01145066|FG002|Participant Flow|Corn Oil|corn oil: contains 4.5 g/day linoleic acid
11018477|NCT01145066|OG000|Outcome|Borage and Echium Oil Combination|"borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA~borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA"
11018478|NCT01145066|OG001|Outcome|Fish Oil|"Croda 18:12 fish oil~fish oil: 1.6g/day EPA and 1.08g/day DHA"
11018479|NCT01145066|OG002|Outcome|Corn Oil|corn oil: contains 4.5 g/day linoleic acid
11018480|NCT01145066|EG000|Reported Event|Borage and Echium Oil Combination|"borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA~borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA"
11018481|NCT01145066|EG001|Reported Event|Fish Oil|"Croda 18:12 fish oil~fish oil: 1.6g/day EPA and 1.08g/day DHA"
11018482|NCT01145066|EG002|Reported Event|Corn Oil|corn oil: contains 4.5 g/day linoleic acid
11018483|NCT01145183|BG000|Baseline|Doxazosin (AA Genotype)|A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
11018484|NCT01145183|BG001|Baseline|Doxazosin (AT/TT Genotype)|A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
11018485|NCT01145183|BG002|Baseline|Placebo (AA Genotype)|Matched placebo daily dosing
11018486|NCT01145183|BG003|Baseline|Placebo (AT/TT Genotype)|Matched placebo daily dosing
11018487|NCT01145183|BG004|Baseline|Total|Total of all reporting groups
11018488|NCT01145183|FG000|Participant Flow|Doxazosin (AA Genotype)|A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
11018489|NCT01145183|FG001|Participant Flow|Doxazosin (AT/TT Genotype)|A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
11148456|NCT01864148|OG003|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018490|NCT01145183|FG002|Participant Flow|Placebo (AA Genotype)|Matched placebo daily dosing
11018491|NCT01145183|FG003|Participant Flow|Placebo (AT/TT Genotype)|Matched placebo daily dosing
11018492|NCT01145183|OG000|Outcome|Doxazosin (AA Genotype)|A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
11018493|NCT01145183|OG001|Outcome|Doxazosin (AT/TT Genotype)|A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
11018494|NCT01145183|OG002|Outcome|Placebo (AA Genotype)|Matched placebo daily dosing
11018495|NCT01145183|OG003|Outcome|Placebo (AT/TT Genotype)|Matched placebo daily dosing
11018496|NCT01145183|OG000|Outcome|Doxazosin|Doxazosin 8 mg/day
11018497|NCT01145183|OG001|Outcome|Placebo|Matched placebo daily dosing.
11018498|NCT01145183|EG000|Reported Event|Doxazosin|Doxazosin 8 mg/day
11018499|NCT01145183|EG001|Reported Event|Placebo|Matched placebo daily dosing.
11018500|NCT01145222|BG000|Baseline|Remimazolam 8.0/3.0 mg|Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance
11018501|NCT01145222|BG001|Baseline|Remimazolam 7.0/2.0 mg|Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance
11018502|NCT01145222|BG002|Baseline|Remimazolam 5.0/3.0 mg|Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance
11018503|NCT01145222|BG003|Baseline|Midazolam 2.5/1.0|Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance.
11018504|NCT01145222|BG004|Baseline|Total|Total of all reporting groups
11018505|NCT01145222|FG000|Participant Flow|Remimazolam 8.0/3.0 mg|Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance
11018506|NCT01145222|FG001|Participant Flow|Remimazolam 7.0/2.0 mg|Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance
11018507|NCT01145222|FG002|Participant Flow|Remimazolam 5.0/3.0 mg|Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance
11018508|NCT01145222|FG003|Participant Flow|Midazolam 2.5/1.0|Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1.0 mg top-ups for sedation maintenance.
11018509|NCT01145222|OG000|Outcome|Remimazolam 8.0/3.0 mg|Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance
11018510|NCT01145222|OG001|Outcome|Remimazolam 7.0/2.0 mg|Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance
11018511|NCT01145222|OG002|Outcome|Remimazolam 5.0/3.0 mg|Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance
11018512|NCT01145222|OG003|Outcome|Midazolam 2.5/1.0|Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance.
11018513|NCT01145222|EG000|Reported Event|Remimazolam 8.0/3.0 mg|Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance
11018514|NCT01145222|EG001|Reported Event|Remimazolam 7.0/2.0 mg|Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance
11018515|NCT01145222|EG002|Reported Event|Remimazolam 5.0/3.0 mg|Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance
11018516|NCT01145222|EG003|Reported Event|Midazolam 2.5/1.0|Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance.
11148457|NCT01864148|OG004|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11148458|NCT01864148|OG005|Outcome|BIIB033 Total|BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
11148459|NCT01864148|OG000|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018517|NCT01145352|BG000|Baseline|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
11018518|NCT01145352|FG000|Participant Flow|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
11018519|NCT01145352|OG000|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
11018520|NCT01145352|EG000|Reported Event|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
11018521|NCT01145391|BG000|Baseline|Control|Patients receive usual care.
11018522|NCT01145391|BG001|Baseline|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
11018523|NCT01145391|BG002|Baseline|Total|Total of all reporting groups
11018524|NCT01145391|FG000|Participant Flow|Control|Patients receive usual care.
11018525|NCT01145391|FG001|Participant Flow|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
11018526|NCT01145391|OG000|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
11018527|NCT01145391|OG001|Outcome|Usual Care|Usual care
11018528|NCT01145391|OG000|Outcome|Control|Patients receive usual care.
11018529|NCT01145391|OG001|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
11018530|NCT01145391|EG000|Reported Event|Control|Patients receive usual care.
11018531|NCT01145391|EG001|Reported Event|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
11018532|NCT01145417|BG000|Baseline|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
11018533|NCT01145417|BG001|Baseline|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
11018534|NCT01145417|BG002|Baseline|Total|Total of all reporting groups
11018535|NCT01145417|FG000|Participant Flow|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
11018536|NCT01145417|FG001|Participant Flow|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
11018537|NCT01145417|OG000|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
11018538|NCT01145417|OG001|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
11018539|NCT01145417|EG000|Reported Event|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
11018540|NCT01145417|EG001|Reported Event|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
11018541|NCT01145482|BG000|Baseline|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline administered once daily on two occasions
11018542|NCT01145482|BG001|Baseline|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin administered once daily on two occasions
11018543|NCT01145482|BG002|Baseline|Total|Total of all reporting groups
11018544|NCT01145482|FG000|Participant Flow|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline once daily on two occasions
11018545|NCT01145482|FG001|Participant Flow|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin once daily on two occasions
11018546|NCT01145482|OG000|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
11018547|NCT01145482|OG001|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
11018548|NCT01145482|EG000|Reported Event|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
11018549|NCT01145482|EG001|Reported Event|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
11018550|NCT01145508|BG000|Baseline|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
11018551|NCT01145508|BG001|Baseline|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
11018552|NCT01145508|BG002|Baseline|Total|Total of all reporting groups
11018553|NCT01145508|FG000|Participant Flow|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
11018554|NCT01145508|FG001|Participant Flow|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
11018555|NCT01145508|OG000|Outcome|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
11018556|NCT01145508|OG001|Outcome|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
11148460|NCT01864148|OG001|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018557|NCT01145508|EG000|Reported Event|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
11018558|NCT01145508|EG001|Reported Event|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
11018559|NCT01145547|BG000|Baseline|All Study Participants|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index and in one experiment, both meals had a high Glycemic Index.~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
11018560|NCT01145547|FG000|Participant Flow|Low Glycemic Index, High Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with low glycemic index followed by a second study consuming meals with a high glycemic index~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
11018561|NCT01145547|FG001|Participant Flow|High Glycemic Index, Low Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with high glycemic index followed by a second study consuming meals with a low glycemic index~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
11018562|NCT01145547|OG000|Outcome|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
11018563|NCT01145547|OG001|Outcome|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
11148461|NCT01864148|OG002|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11148462|NCT01864148|OG003|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018564|NCT01145547|EG000|Reported Event|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
11018565|NCT01145547|EG001|Reported Event|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
11018566|NCT01145560|BG000|Baseline|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
11018567|NCT01145560|BG001|Baseline|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
11018568|NCT01145560|BG002|Baseline|Placebo|Saline
11018569|NCT01145560|BG003|Baseline|Total|Total of all reporting groups
11018570|NCT01145560|FG000|Participant Flow|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
11018571|NCT01145560|FG001|Participant Flow|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
11018572|NCT01145560|FG002|Participant Flow|Placebo|Saline
11018573|NCT01145560|OG000|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
11018574|NCT01145560|OG001|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
11018575|NCT01145560|OG002|Outcome|Placebo|Saline
11018576|NCT01145560|EG000|Reported Event|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
11018577|NCT01145560|EG001|Reported Event|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
11018578|NCT01145560|EG002|Reported Event|Placebo|Saline
11018579|NCT01145625|BG000|Baseline|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
11018580|NCT01145625|BG001|Baseline|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
11018581|NCT01145625|BG002|Baseline|Total|Total of all reporting groups
11018582|NCT01145625|FG000|Participant Flow|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
11018583|NCT01145625|FG001|Participant Flow|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
11018584|NCT01145625|OG000|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
11018585|NCT01145625|OG001|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
11018586|NCT01145625|EG000|Reported Event|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
11018587|NCT01145625|EG001|Reported Event|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
11018588|NCT01145638|BG000|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
11018589|NCT01145638|BG001|Baseline|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
11018590|NCT01145638|BG002|Baseline|Total|Total of all reporting groups
11018591|NCT01145638|FG000|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
11018592|NCT01145638|FG001|Participant Flow|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
11018593|NCT01145638|OG000|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
11018594|NCT01145638|OG001|Outcome|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
11018595|NCT01145638|EG000|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
11018596|NCT01145638|EG001|Reported Event|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
11018597|NCT01145755|BG000|Baseline|AZD2066|AZD2066 12 mg, 18 mg
11018598|NCT01145755|BG001|Baseline|Duloxetine|Duloxetine 30 mg, 60 mg
11018599|NCT01145755|BG002|Baseline|Placebo|Placebo
11018600|NCT01145755|BG003|Baseline|Total|Total of all reporting groups
11018601|NCT01145755|FG000|Participant Flow|AZD2066|AZD2066 12 mg, 18 mg
11018602|NCT01145755|FG001|Participant Flow|Duloxetine|Duloxetine 30 mg, 60 mg
11018603|NCT01145755|FG002|Participant Flow|Placebo|Placebo
11018604|NCT01145755|OG000|Outcome|AZD2066|AZD2066 12 mg, 18 mg
11018605|NCT01145755|OG001|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
11018606|NCT01145755|OG002|Outcome|Placebo|Placebo
11018607|NCT01145755|EG000|Reported Event|AZD2066|AZD2066 12 mg, 18 mg
11018608|NCT01145755|EG001|Reported Event|Duloxetine|Duloxetine 30 mg, 60 mg
11018609|NCT01145755|EG002|Reported Event|Placebo|Placebo
11018610|NCT01145833|BG000|Baseline|Immediate Treatment Group|The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
11018611|NCT01145833|BG001|Baseline|Delayed Treatment Group|The delayed treatment group serves as the control group.
11018612|NCT01145833|BG002|Baseline|Total|Total of all reporting groups
11018613|NCT01145833|FG000|Participant Flow|Immediate Treatment Group|The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
11018614|NCT01145833|FG001|Participant Flow|Delayed Treatment Group|The delayed treatment group serves as the control group.
11018615|NCT01145833|OG000|Outcome|Immediate Treatment Group|The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
11018616|NCT01145833|OG001|Outcome|Delayed Treatment Group|The delayed treatment group serves as the control group.
11018617|NCT01145833|EG000|Reported Event|Immediate Treatment Group|The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
11018618|NCT01145833|EG001|Reported Event|Delayed Treatment Group|The delayed treatment group serves as the control group.
11018619|NCT01145885|BG000|Baseline|Volasertib|Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
11018620|NCT01145885|FG000|Participant Flow|Volasertib|Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
11018621|NCT01145885|OG000|Outcome|Volasertib 14C 300 mg|Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
11018622|NCT01145885|OG001|Outcome|Volasertib 300mg|Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
11018623|NCT01145885|OG002|Outcome|Volasertib 250mg|Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
11018624|NCT01145885|EG000|Reported Event|Volasertib 14C 300mg|Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
11018625|NCT01145885|EG001|Reported Event|Volasertib 300mg|Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
11018626|NCT01145885|EG002|Reported Event|Total_Volasertib 300|Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days) and patient who continued into further treatment cycles and received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle.
11018627|NCT01145885|EG003|Reported Event|Volasertib 250mg|Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
11018628|NCT01145885|EG004|Reported Event|Volasertib|Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
11018629|NCT01145898|BG000|Baseline|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
11018630|NCT01145898|BG001|Baseline|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
11018631|NCT01145898|BG002|Baseline|Total|Total of all reporting groups
11018632|NCT01145898|FG000|Participant Flow|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
11018633|NCT01145898|FG001|Participant Flow|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
11018634|NCT01145898|OG000|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
11018635|NCT01145898|OG001|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
11018636|NCT01145898|EG000|Reported Event|Glaucoma Patients|Patients with Glaucoma
11018637|NCT01146054|BG000|Baseline|SBRT and Gemzar|"Before stereotactic Body Radiotherapy (SBRT) 3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles should resume/start up to 4 weeks following SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Device: CyberKnife based stereotactic radiotherapy"
11018638|NCT01146054|FG000|Participant Flow|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose 18F-positron emission tomography/computerized tomography) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D (4 dimensional) pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
11018639|NCT01146054|OG000|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
11018640|NCT01146054|EG000|Reported Event|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
11148463|NCT01864148|EG000|Reported Event|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
11018641|NCT01146275|BG000|Baseline|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
11018642|NCT01146275|FG000|Participant Flow|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
11018643|NCT01146275|OG000|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.~Radiologial breast examination : MRI of breast, mammography and ultrasound of breast The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment."
11018644|NCT01146275|OG000|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.~Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"
11018645|NCT01146275|EG000|Reported Event|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
11018646|NCT01146288|BG000|Baseline|Acetazolamide First, Then Furosemide|intravenous acetazolamide 5 mg/kg/5 min. in first intervention period, intravenous furosemide 2 mg/5min in second intervention period (after washout period).
11018647|NCT01146288|BG001|Baseline|Furosemide First, Then Acetazolamide|intravenous furosemide 2 mg/5min. in first intervention period, intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
11018648|NCT01146288|BG002|Baseline|Total|Total of all reporting groups
11018649|NCT01146288|FG000|Participant Flow|Acetazolamide First, Then Furosemide|Intravenous acetazolamide 5 mg/kg/5 min. in first intervention period and intravenous furosemide 2 mg/5min in second intervention period (after washout period).
11018650|NCT01146288|FG001|Participant Flow|Furosemide First , Than Acetazolamide|Intravenous furosemide 2 mg/5min in first intervention period and intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
11018651|NCT01146288|OG000|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
11018652|NCT01146288|OG001|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
11018653|NCT01146288|EG000|Reported Event|Acetazolamide|Intravenous acetazolamide 5 mg/kg/5 min.
11018654|NCT01146288|EG001|Reported Event|Furosemide|Intravenous furosemide 2 mg/5min
11018655|NCT01146288|EG002|Reported Event|P-aminohippuric Acid|Intravenous priming dose of p-aminohippuric acid (8 mg/kg) before diuretics administration
11018656|NCT01146379|BG000|Baseline|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018657|NCT01146379|BG001|Baseline|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018658|NCT01146379|BG002|Baseline|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018659|NCT01146379|BG003|Baseline|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018660|NCT01146379|BG004|Baseline|Total|Total of all reporting groups
11018661|NCT01146379|FG000|Participant Flow|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11148464|NCT01864148|EG001|Reported Event|BIIB033 3 mg/kg|BIIB033 3 mg/kg once every 4 weeks IV infusion
11148465|NCT01864148|EG002|Reported Event|BIIB033 10 mg/kg|BIIB033 10 mg/kg once every 4 weeks IV infusion
11018662|NCT01146379|FG001|Participant Flow|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018663|NCT01146379|FG002|Participant Flow|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018664|NCT01146379|FG003|Participant Flow|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018665|NCT01146379|OG000|Outcome|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018666|NCT01146379|OG001|Outcome|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018667|NCT01146379|OG002|Outcome|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018668|NCT01146379|OG003|Outcome|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018669|NCT01146379|EG000|Reported Event|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018670|NCT01146379|EG001|Reported Event|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018671|NCT01146379|EG002|Reported Event|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11148466|NCT01864148|EG003|Reported Event|BIIB033 30 mg/kg|BIIB033 30 mg/kg once every 4 weeks IV infusion
11148467|NCT01864148|EG004|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg once every 4 weeks IV infusion
11341280|NCT03680105|EG004|Reported Event|Part 1; Cohort 4; RJX|Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX on Day 1.
11018672|NCT01146379|EG003|Reported Event|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
11018673|NCT01146457|BG000|Baseline|Placebo|Saline control
11018674|NCT01146457|BG001|Baseline|Morphine 25|Morphine 25 micrograms
11018675|NCT01146457|BG002|Baseline|Morphine 50|Morphine 50 micrograms
11018676|NCT01146457|BG003|Baseline|Hine 75|Morphine 75 micrograms
11018677|NCT01146457|BG004|Baseline|Morphine 100|Morphine 100 micrograms
11018678|NCT01146457|BG005|Baseline|Total|Total of all reporting groups
11018679|NCT01146457|FG000|Participant Flow|Placebo|Saline: Saline Control
11018680|NCT01146457|FG001|Participant Flow|Morphine 25|Morphine 25 micrograms: Active dosage
11018681|NCT01146457|FG002|Participant Flow|Morphine 50|Morphine 50 micrograms: Active dosage
11018682|NCT01146457|FG003|Participant Flow|Morphine 75|Morphine 75 micrograms: Active dosage
11018683|NCT01146457|FG004|Participant Flow|Morphine 100|Morphine 100 micrograms: Active dosage
11018684|NCT01146457|OG000|Outcome|Control|Saline Control
11018685|NCT01146457|OG001|Outcome|Morphine 25|Morphine 25 micrograms
11018686|NCT01146457|OG002|Outcome|Morphine 50|Morphine 50 micrograms
11018687|NCT01146457|OG003|Outcome|Morphine 75|Morphine 75 micrograms
11018688|NCT01146457|OG004|Outcome|Morphine 100|Morphine 100 micrograms
11018689|NCT01146457|EG000|Reported Event|Placebo|Saline: Saline Control
11018690|NCT01146457|EG001|Reported Event|Morphine 25|Morphine: Active dosage
11018691|NCT01146457|EG002|Reported Event|Morphine 50|Morphine: Active dosage
11018692|NCT01146457|EG003|Reported Event|Morphine 75|Morphine: Active dosage
11018693|NCT01146457|EG004|Reported Event|Morphine 100|Morphine: Active dosage
11018694|NCT01146496|BG000|Baseline|Storage Container|"Ultraviolet light resistant plastic in-ground pesticide storage container~Ultraviolet light-resistant plastic in-ground pesticide storage container: In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages"
11018695|NCT01146496|BG001|Baseline|Control|
11018696|NCT01146496|BG002|Baseline|Total|Total of all reporting groups
11018697|NCT01146496|FG000|Participant Flow|Storage Container|"Ultraviolet light resistant plastic in-ground pesticide storage container~Ultraviolet light-resistant plastic in-ground pesticide storage container: In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages"
11018698|NCT01146496|FG001|Participant Flow|Control|No intervention
11018699|NCT01146496|OG000|Outcome|Storage Container|"Ultraviolet light resistant plastic in-ground pesticide storage container~Ultraviolet light-resistant plastic in-ground pesticide storage container: In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages"
11018700|NCT01146496|OG001|Outcome|Control|
11018701|NCT01146496|OG001|Outcome|Control|No intervention
11018702|NCT01146496|EG000|Reported Event|Storage Container|"Ultraviolet light resistant plastic in-ground pesticide storage container~Ultraviolet light-resistant plastic in-ground pesticide storage container: In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages"
11018703|NCT01146496|EG001|Reported Event|Control|No intervention
11018704|NCT01146561|BG000|Baseline|Placebo|A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
11018705|NCT01146561|FG000|Participant Flow|Placebo|A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
11018706|NCT01146561|OG000|Outcome|Placebo|A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
11018707|NCT01146561|EG000|Reported Event|Placebo|A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
11018708|NCT01146600|BG000|Baseline|Clarithromycin, Then Placebo|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.~Clarithromycin followed by placebo : Clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks, then one week with no medication, then matched placebo po bid (with breakfast and lunch) for two weeks."
11018709|NCT01146600|BG001|Baseline|Placebo, Then Clarithromycin|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.~Placebo then Clarithromycin : Matched placebo po bid (with breakfast and lunch) for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks"
11018710|NCT01146600|BG002|Baseline|Total|Total of all reporting groups
11018711|NCT01146600|FG000|Participant Flow|Clarithromycin, Then Placebo|Subjects randomized to receive clarithromycin first (for two weeks), then matched placebo (for an additional two weeks, following the washout)
11018712|NCT01146600|FG001|Participant Flow|Placebo, Then Clarithromycin|Subjects randomized to receive placebo first (for two weeks), then clarithromycin (for an additional two weeks, following the washout)
11018713|NCT01146600|OG000|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
11018714|NCT01146600|OG001|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
11018715|NCT01146600|OG002|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
11018716|NCT01146600|EG000|Reported Event|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
11018717|NCT01146600|EG001|Reported Event|Placebo|Matched placebo with breakfast and with lunch for two weeks
11018718|NCT01146613|BG000|Baseline|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
11018719|NCT01146613|BG001|Baseline|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
11018720|NCT01146613|BG002|Baseline|Total|Total of all reporting groups
11018721|NCT01146613|FG000|Participant Flow|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
11018722|NCT01146613|FG001|Participant Flow|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
11018723|NCT01146613|OG000|Outcome|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
11018724|NCT01146613|OG001|Outcome|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
11018725|NCT01146613|EG000|Reported Event|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
11018726|NCT01146613|EG001|Reported Event|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
11018727|NCT01146665|BG000|Baseline|Standard Medical Care Followed by Computer-based PAF|Standard medical care followed by a brief intervention (computer-based personalized assessment feedback) that targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.
11018728|NCT01146665|BG001|Baseline|Standard Medical Care Followed by Computer-based Sham|Standard medical care followed by a computer-based sham intervention. The sham was similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions.
11018729|NCT01146665|BG002|Baseline|Total|Total of all reporting groups
11018730|NCT01146665|FG000|Participant Flow|Medical Care Plus Computer-based PAF|Computer-based Personalized Assessment Feedback: This brief intervention targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.
11018731|NCT01146665|FG001|Participant Flow|Medical Care Plus Computer-based Sham|Computer-based sham: Similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions.
11018732|NCT01146665|OG000|Outcome|Standard Medical Care Followed by Computer-based PAF|Standard medical care followed by a brief intervention (personalized assessment feedback) that targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.
11018733|NCT01146665|OG001|Outcome|Standard Medical Care Followed by Computer-based Sham|Standard medical care followed by a computer-based sham intervention. The sham was similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions.
11018734|NCT01146665|OG000|Outcome|All Participants|The recruitment rate relates to recruitment into the study, and not recruitment per arm as randomization and allocation occurred after enrolment.
11018735|NCT01146665|OG000|Outcome|All Participants|The retention rate was calculated as the number participants participating in follow-up data collection divided by the total number of study participants.
11018736|NCT01146665|OG000|Outcome|Research Staff|
11018737|NCT01146665|OG001|Outcome|ED Physicians|
11018738|NCT01146665|OG002|Outcome|ED Nurses|
11018739|NCT01146665|OG000|Outcome|Medical Care Plus Computer-based PAF|Computer-based Personalized Assessment Feedback: This brief intervention targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.
11018740|NCT01146665|OG000|Outcome|All Participants|
11018741|NCT01146665|OG001|Outcome|Standard Medical Care Followed by Computer-based PAF|Standard medical care followed by a brief intervention (computer-based personalized assessment feedback) that targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.
11018742|NCT01146665|OG002|Outcome|Standard Medical Care Followed by Computer-based Sham|Standard medical care followed by a computer-based sham intervention. The sham was similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions.
11018743|NCT01146665|EG000|Reported Event|Standard Medical Care Followed by Computer-based PAF|Standard medical care followed by a brief intervention (computer-based personalized assessment feedback) that targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.
11018744|NCT01146665|EG001|Reported Event|Standard Medical Care Followed by Computer-based Sham|Standard medical care followed by a computer-based sham intervention. The sham was similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions.
11018745|NCT01146704|BG000|Baseline|Standard Diet|"Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.~Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass: Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate."
11018746|NCT01146704|BG001|Baseline|High Protein Diet|"High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.~Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate: High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate."
11018747|NCT01146704|BG002|Baseline|Total|Total of all reporting groups
11341281|NCT03680105|EG005|Reported Event|Part 1; Cohort 5; RJX|Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX on Day 1.
11018748|NCT01146704|FG000|Participant Flow|Standard Diet|"Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.~Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass: Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate."
11018749|NCT01146704|FG001|Participant Flow|High Protein Diet|"High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.~Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate: High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate."
11018750|NCT01146704|OG000|Outcome|Standard Diet|"Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.~Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass: Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate."
11018751|NCT01146704|OG001|Outcome|High Protein Diet|"High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.~Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate: High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate."
11018752|NCT01146704|EG000|Reported Event|Standard Diet|"Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.~Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass: Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate."
11018753|NCT01146704|EG001|Reported Event|High Protein Diet|"High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.~Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate: High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate."
11018754|NCT01146782|BG000|Baseline|Safety Cohort|Demographics and Baseline Characteristics are presented for the Safety Cohort (N=146)
11018755|NCT01146782|FG000|Participant Flow|Sleep Apnea Treatment (Primary Endpoint Cohort)|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) polysomnogram (PSG).
11018756|NCT01146782|OG000|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
11018757|NCT01146782|OG000|Outcome|Safety Cohort|The Safety Cohort is comprised of all subjects with at least one night of Winx therapy usage.
11018758|NCT01146782|EG000|Reported Event|Safety Cohort|Device related adverse events are presented for the Safety Cohort.
11018759|NCT01146795|BG000|Baseline|Carboplatin, Paclitaxel, and Bevacizumab|Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
11018760|NCT01146795|FG000|Participant Flow|Carboplatin, Paclitaxel, and Bevacizumab|Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
11018761|NCT01146795|OG000|Outcome|Carboplatin, Paclitaxel, and Bevacizumab|Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
11018762|NCT01146795|EG000|Reported Event|Carboplatin, Paclitaxel, and Bevacizumab|Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
11148468|NCT01864174|BG000|Baseline|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
11148469|NCT01864174|BG001|Baseline|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
11148470|NCT01864174|BG002|Baseline|Total|Total of all reporting groups
11148471|NCT01864174|FG000|Participant Flow|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
11148472|NCT01864174|FG001|Participant Flow|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
11341282|NCT03680105|EG006|Reported Event|Part 1; Cohort 6; RJX|"Participants in Part 1; Cohort 6 receive a single dose of 0.500 mL/kg RJX on Day 1.~Cohort 6 subjects comprised a cohort of healthy volunteers aged 50-70 inclusive."
11148473|NCT01864174|OG000|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
11148474|NCT01864174|OG001|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
11148475|NCT01864174|EG000|Reported Event|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
11148476|NCT01864174|EG001|Reported Event|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
11148477|NCT01864200|BG000|Baseline|CroFab|"Crotalidae Polyvalent Immune Fab (ovine) per approved labeling~Crotalidae Polyvalent Immune Fab (ovine): crotalidae antivenom"
11148478|NCT01864200|BG001|Baseline|Saline Placebo|"Saline placebo~Placebo"
11148479|NCT01864200|BG002|Baseline|Total|Total of all reporting groups
11148480|NCT01864200|FG000|Participant Flow|CroFab|"crotilidae polyvalent immune fab (ovine) per approved labeling~crotilidae polyvalent immune fab (ovine): crotilidae antivenom"
11148481|NCT01864200|FG001|Participant Flow|Saline Placebo|"Saline placebo~Placebo"
11148482|NCT01864200|OG000|Outcome|CroFab|"crotilidae polyvalent immune fab (ovine) per approved labeling~crotilidae polyvalent immune fab (ovine): crotilidae antivenom"
11148483|NCT01864200|OG001|Outcome|Saline Placebo|"Saline placebo~Placebo"
11148484|NCT01864200|EG000|Reported Event|CroFab|"crotilidae polyvalent immune fab (ovine) per approved labeling~crotilidae polyvalent immune fab (ovine): crotilidae antivenom"
11148485|NCT01864200|EG001|Reported Event|Saline Placebo|"Saline placebo~Placebo"
11148486|NCT01864291|BG000|Baseline|Non-NF2 ABI Surgery|Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
11148487|NCT01864291|FG000|Participant Flow|Non-NF2 ABI Surgery|Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
11148488|NCT01864291|OG000|Outcome|Non-NF2 ABI Surgery|Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
11148489|NCT01864291|EG000|Reported Event|Non-NF2 ABI Surgery|Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
11148490|NCT01864434|BG000|Baseline|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
11148491|NCT01864434|BG001|Baseline|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
11148492|NCT01864434|BG002|Baseline|Total|Total of all reporting groups
11018763|NCT01146808|BG000|Baseline|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
11148493|NCT01864434|FG000|Participant Flow|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
11148494|NCT01864434|FG001|Participant Flow|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
11148495|NCT01864434|OG000|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
11148496|NCT01864434|OG001|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
11148497|NCT01864434|EG000|Reported Event|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
11148498|NCT01864434|EG001|Reported Event|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
11148499|NCT01864525|BG000|Baseline|Inactive Capsule First|"Participants who were randomized to receive a capsule with an inactive ingredient (placebo) during the first 3 weeks of the study (placebo arm of crossover design study), and then received octanoic acid in the last 3 weeks of the study.~Placebo"
11148500|NCT01864525|BG001|Baseline|Octanoic Acid First|"Participants who were randomized to receive a capsule with octanoic acid (amount determined by the participant's weight) during the first 3 weeks of the study (experimental arm of crossover design study), and then received the placebo in the last 3 weeks of the study.~Octanoic acid"
11148501|NCT01864525|BG002|Baseline|Total|Total of all reporting groups
11148502|NCT01864525|FG000|Participant Flow|Inactive Capsule First|"Participants who were randomized to receive a capsule with an inactive ingredient (placebo) during the first 3 weeks of the study (placebo arm of crossover design study), and then received octanoic acid in the last 3 weeks of the study.~Placebo"
11148503|NCT01864525|FG001|Participant Flow|Octanoic Acid First|"Participants who were randomized to receive a capsule with octanoic acid (amount determined by the participant's weight) during the first 3 weeks of the study (experimental arm of crossover design study), and then received the placebo in the last 3 weeks of the study.~Octanoic acid"
11148504|NCT01864525|OG000|Outcome|Placebo|"Participants who received a capsule with an inactive ingredient (placebo) during either the first or last 3 weeks of the study.~Placebo"
11148505|NCT01864525|OG001|Outcome|Octanoic Acid|"Participants who received a capsule with octanoic acid (amount determined by the participant's weight) during either the first or last 3 weeks of the study.~Octanoic acid"
11148506|NCT01864525|EG000|Reported Event|Placebo|Study phase 1 or 2, when participants were randomized to the 3-week intervention phase in which an inactive capsule (placebo or inactive drug) was taken once a day for 3 weeks.
11148507|NCT01864525|EG001|Reported Event|Octanoic Acid|Study phase 1 or 2, when participants were randomized to the 3-week intervention phase in which octanoic acid (the active drug) was taken once a day for 3 weeks.
11148508|NCT01864538|BG000|Baseline|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.~TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
11148509|NCT01864538|FG000|Participant Flow|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.~TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
11148510|NCT01864538|OG000|Outcome|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.~TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
11148511|NCT01864538|EG000|Reported Event|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.~TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
11148512|NCT01864564|BG000|Baseline|Routine Screening|"Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care.~All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation."
11148513|NCT01864564|BG001|Baseline|Early Screening|"Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care.~All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.~Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks."
11148514|NCT01864564|BG002|Baseline|Total|Total of all reporting groups
11018764|NCT01146808|FG000|Participant Flow|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
11148515|NCT01864564|FG000|Participant Flow|Routine Screening|"Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care.~All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation."
11148516|NCT01864564|FG001|Participant Flow|Early Screening|"Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care.~All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.~Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks."
11148517|NCT01864564|OG000|Outcome|Routine Screening|"Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care.~All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation."
11148518|NCT01864564|OG001|Outcome|Early Screening|"Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care.~All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.~Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks."
11148519|NCT01864564|EG000|Reported Event|Routine Screening|"Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care.~All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation."
11148520|NCT01864564|EG001|Reported Event|Early Screening|"Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care.~All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.~Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks."
11148521|NCT01865084|BG000|Baseline|Placebo|Placebo taken orally once daily.
11148522|NCT01865084|BG001|Baseline|0.3 mg/kg Tadalafil|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
11148523|NCT01865084|BG002|Baseline|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
11148524|NCT01865084|BG003|Baseline|Total|Total of all reporting groups
11148525|NCT01865084|FG000|Participant Flow|Placebo|Placebo taken orally once daily.
11148526|NCT01865084|FG001|Participant Flow|0.3 mg/kg Tadalafil|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
11148527|NCT01865084|FG002|Participant Flow|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
11148528|NCT01865084|OG000|Outcome|Placebo|Placebo taken orally once daily.
11148529|NCT01865084|OG001|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
11148530|NCT01865084|OG002|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg taken tadalafil orally once daily.
11148531|NCT01865084|OG002|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
11148532|NCT01865084|OG000|Outcome|0.3 mg/kg Tadalafil and 0.6 mg/kg Tadalafil|"0.3 mg/kg tadalafil taken orally once daily.~0.6 mg/kg tadalafil taken orally once daily."
11148533|NCT01865084|EG000|Reported Event|Placebo - DB|Placebo taken orally once daily.
11018765|NCT01146808|OG000|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
11018766|NCT01146808|EG000|Reported Event|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
11018767|NCT01146834|BG000|Baseline|Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF|"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018768|NCT01146834|BG001|Baseline|Arm B: VELCADE & G-CSF|"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018769|NCT01146834|BG002|Baseline|Arm C: CYCLOPHOSPHAMIDE & G-CSF|"High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.~cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018770|NCT01146834|BG003|Baseline|Arm D: PLERIXAFOR & G-CSF|"G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)~Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)"
11018771|NCT01146834|BG004|Baseline|Arm E: PLERIXAFOR, VELCADE, & G-CSF|"Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.~Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)~Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)"
11018772|NCT01146834|BG005|Baseline|Total|Total of all reporting groups
11018773|NCT01146834|FG000|Participant Flow|Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF|"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)"
11018774|NCT01146834|FG001|Participant Flow|Arm B: VELCADE & G-CSF|"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)"
11018775|NCT01146834|FG002|Participant Flow|Arm C: CYCLOPHOSPHAMIDE & G-CSF|"High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.~cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)"
11018776|NCT01146834|FG003|Participant Flow|Arm D: PLERIXAFOR & G-CSF|"G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)~Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)"
11066187|NCT01390948|BG001|Baseline|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
11066188|NCT01390948|BG002|Baseline|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
11066189|NCT01390948|BG003|Baseline|Total|Total of all reporting groups
11018777|NCT01146834|FG004|Participant Flow|Arm E: PLERIXAFOR, VELCADE, & G-CSF|"Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.~Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)~Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)"
11018778|NCT01146834|OG000|Outcome|Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF|"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018779|NCT01146834|OG001|Outcome|Arm B: VELCADE & G-CSF|"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018780|NCT01146834|OG002|Outcome|Arm C: CYCLOPHOSPHAMIDE & G-CSF|"High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.~cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018781|NCT01146834|OG003|Outcome|Arm D: PLERIXAFOR & G-CSF|"G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)~Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)"
11018782|NCT01146834|OG004|Outcome|Arm E: PLERIXAFOR, VELCADE, & G-CSF|"Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.~Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)~Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)"
11018783|NCT01146834|EG000|Reported Event|Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF|"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018784|NCT01146834|EG001|Reported Event|Arm B: VELCADE & G-CSF|"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018785|NCT01146834|EG002|Reported Event|Arm C: CYCLOPHOSPHAMIDE & G-CSF|"High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.~cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)"
11018786|NCT01146834|EG003|Reported Event|Arm D: PLERIXAFOR & G-CSF|"G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)~Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)"
11066190|NCT01390948|FG000|Participant Flow|Chemoradiation + TMZ|Participants received a total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 milligrams per meter squared (mg/m^2) TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
11148534|NCT01865084|EG001|Reported Event|0.3 mg/kg Tadalafil -DB|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
11018787|NCT01146834|EG004|Reported Event|Arm E: PLERIXAFOR, VELCADE, & G-CSF|"Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.~Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.~bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11~G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)~Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)"
11018788|NCT01146860|BG000|Baseline|BNO 1016|sugar coated tablets
11018789|NCT01146860|BG001|Baseline|Placebo|sugar coated tablets
11018790|NCT01146860|BG002|Baseline|Total|Total of all reporting groups
11018791|NCT01146860|FG000|Participant Flow|BNO 1016|sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; daily dose: 480 mg (2 tablets tid)
11018792|NCT01146860|FG001|Participant Flow|Placebo|sugar coated tablets of identical appearance to active treatment
11018793|NCT01146860|OG000|Outcome|BNO 1016|sugar coated tablets
11018794|NCT01146860|OG001|Outcome|Placebo|sugar coated tablets
11018795|NCT01146860|EG000|Reported Event|BNO 1016|sugar coated tablets
11018796|NCT01146860|EG001|Reported Event|Placebo|sugar coated tablets
11018797|NCT01146873|BG000|Baseline|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
11018798|NCT01146873|BG001|Baseline|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
11018799|NCT01146873|BG002|Baseline|Total|Total of all reporting groups
11018800|NCT01146873|FG000|Participant Flow|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
11018801|NCT01146873|FG001|Participant Flow|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
11018802|NCT01146873|OG000|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
11018803|NCT01146873|OG001|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
11018804|NCT01146873|EG000|Reported Event|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher
11018805|NCT01146873|EG001|Reported Event|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
11018806|NCT01146912|BG000|Baseline|Text Message Vaccine Reminders/Automated Telephone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
11018807|NCT01146912|BG001|Baseline|Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
11018808|NCT01146912|BG002|Baseline|Pregnant Women: Text Message|
11018809|NCT01146912|BG003|Baseline|Pregnant Women: Usual Care|
11018810|NCT01146912|BG004|Baseline|Delayed Pediatrics: Interactive Text Message|
11018811|NCT01146912|BG005|Baseline|Delayed Pediatrics: Conventional Text Message|
11018812|NCT01146912|BG006|Baseline|Delayed Pediatrics: Usual Care|
11018813|NCT01146912|BG007|Baseline|Total|Total of all reporting groups
11018814|NCT01146912|FG000|Participant Flow|Pediatric Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
11018815|NCT01146912|FG001|Participant Flow|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
11018816|NCT01146912|FG002|Participant Flow|Pregnant Women: Text Message|Received text message reminders
11018817|NCT01146912|FG003|Participant Flow|Pregnant Women: Usual Care|Received usual care
11018818|NCT01146912|FG004|Participant Flow|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
11018819|NCT01146912|FG005|Participant Flow|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
11018820|NCT01146912|FG006|Participant Flow|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
11018821|NCT01146912|FG007|Participant Flow|Parents|Included in enrollment but not in outcomes which are on child level
11018822|NCT01146912|OG000|Outcome|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
11018823|NCT01146912|OG001|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
11018824|NCT01146912|OG000|Outcome|Pediatric: Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
11018825|NCT01146912|OG000|Outcome|Text Message Vaccine Reminders|"Receipt of text message vaccine reminders~Text Message: Text message vaccine reminders~automated call: Automated call"
11018826|NCT01146912|OG001|Outcome|Automated Phone Call From Clinic|"Receipt of automated phone call from clinic~automated call: Automated call"
11018827|NCT01146912|OG000|Outcome|Pregnant Women: Text Message|
11018828|NCT01146912|OG001|Outcome|Pregnant Women: Usual Care|
11018829|NCT01146912|OG000|Outcome|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
11018830|NCT01146912|OG001|Outcome|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
11018831|NCT01146912|OG002|Outcome|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
11018832|NCT01146912|EG000|Reported Event|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
11148535|NCT01865084|EG002|Reported Event|0.6 mg/kg Tadalafil - DB|0.6 mg/kg tadalafil taken orally once daily.
11018833|NCT01146912|EG001|Reported Event|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
11018834|NCT01146912|EG002|Reported Event|Pregnant Women: Text Message|
11018835|NCT01146912|EG003|Reported Event|Pregnant Women: Usual Care|
11018836|NCT01146912|EG004|Reported Event|Delayed Pediatric: Interactive Text Message|
11018837|NCT01146912|EG005|Reported Event|Delayed Pediatric: Conventional Text Message|
11018838|NCT01146912|EG006|Reported Event|Delayed Pediatric: Usual Care|
11018839|NCT01146951|BG000|Baseline|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
11018840|NCT01146951|BG001|Baseline|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
11018841|NCT01146951|BG002|Baseline|Total|Total of all reporting groups
11018842|NCT01146951|FG000|Participant Flow|Rufinamide (E2080)|"Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.~Target maintenance dose:~15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)"
11018843|NCT01146951|FG001|Participant Flow|Placebo|Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
11018844|NCT01146951|OG000|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
11018845|NCT01146951|OG001|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
11018846|NCT01146951|EG000|Reported Event|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
11018847|NCT01146951|EG001|Reported Event|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
11018848|NCT01147055|BG000|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg IRT first and then crizotinib 250 mg + rifampin 600 mg.
11018849|NCT01147055|FG000|Participant Flow|Crizotinib 250 mg|Single oral dose of crizotinib 250 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
11018850|NCT01147055|FG001|Participant Flow|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in fasted state from Day 1 to Day 14. A single oral dose of crizotinib 250 mg IRTs was administered on Day 9 in second intervention period. A washout period of at least 14 days was maintained between each period.
11018851|NCT01147055|OG000|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
11148536|NCT01865084|EG003|Reported Event|0.3 mg/kg Tadalafil - OLE|0.3 mg/kg tadalafil taken orally once daily.
11148537|NCT01865084|EG004|Reported Event|0.6 mg/kg Tadalafil - OLE|0.6 mg/kg tadalafil taken orally once daily.
11148538|NCT01865448|BG000|Baseline|Control|Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
11018852|NCT01147055|OG001|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
11018853|NCT01147055|EG000|Reported Event|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
11018854|NCT01147055|EG001|Reported Event|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
11018855|NCT01147068|BG000|Baseline|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018856|NCT01147068|BG001|Baseline|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018857|NCT01147068|BG002|Baseline|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018858|NCT01147068|BG003|Baseline|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018859|NCT01147068|BG004|Baseline|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018860|NCT01147068|BG005|Baseline|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018861|NCT01147068|BG006|Baseline|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018862|NCT01147068|BG007|Baseline|Total|Total of all reporting groups
11018863|NCT01147068|FG000|Participant Flow|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018864|NCT01147068|FG001|Participant Flow|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018865|NCT01147068|FG002|Participant Flow|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018866|NCT01147068|FG003|Participant Flow|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018867|NCT01147068|FG004|Participant Flow|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018868|NCT01147068|FG005|Participant Flow|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018869|NCT01147068|FG006|Participant Flow|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018870|NCT01147068|OG000|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018871|NCT01147068|OG001|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018872|NCT01147068|OG002|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018873|NCT01147068|OG003|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018874|NCT01147068|OG004|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018875|NCT01147068|OG005|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018876|NCT01147068|OG006|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018877|NCT01147068|EG000|Reported Event|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018878|NCT01147068|EG001|Reported Event|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018879|NCT01147068|EG002|Reported Event|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018880|NCT01147068|EG003|Reported Event|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018881|NCT01147068|EG004|Reported Event|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018882|NCT01147068|EG005|Reported Event|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018883|NCT01147068|EG006|Reported Event|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
11018884|NCT01147107|BG000|Baseline|Raltegravir Based Therapy|"Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily~Raltegravir: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily"
11018885|NCT01147107|BG001|Baseline|Efavirenz Based Therapy|"Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily~Efavirenz: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily"
11018886|NCT01147107|BG002|Baseline|Total|Total of all reporting groups
11018887|NCT01147107|FG000|Participant Flow|Raltegravir Based Therapy|"Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily~Raltegravir: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily"
11018888|NCT01147107|FG001|Participant Flow|Efavirenz Based Therapy|"Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily~Efavirenz: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily"
10886227|NCT00492856|FG000|Participant Flow|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
11018889|NCT01147107|OG000|Outcome|Raltegravir Based Therapy|"Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily~Raltegravir: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily"
11018890|NCT01147107|OG001|Outcome|Efavirenz Based Therapy|"Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily~Efavirenz: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily"
11018891|NCT01147107|EG000|Reported Event|Raltegravir Based Therapy|"Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily~Raltegravir: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily"
11018892|NCT01147107|EG001|Reported Event|Efavirenz Based Therapy|"Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily~Efavirenz: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily"
11018893|NCT01147172|BG000|Baseline|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite~Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
11018894|NCT01147172|FG000|Participant Flow|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite~Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
11018895|NCT01147172|OG000|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
11018896|NCT01147172|OG000|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation at End of Study.
11018897|NCT01147172|OG000|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
11018898|NCT01147172|EG000|Reported Event|Safety Population|All Subjects receiving treatment of nasolabial folds (NLF) with injection of Elevess.
11018899|NCT01147250|BG000|Baseline|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
11018900|NCT01147250|BG001|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
11018901|NCT01147250|BG002|Baseline|Total|Total of all reporting groups
11018902|NCT01147250|FG000|Participant Flow|Placebo|Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).
11018903|NCT01147250|FG001|Participant Flow|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
11018904|NCT01147250|OG000|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
11018905|NCT01147250|OG001|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
11018906|NCT01147250|EG000|Reported Event|Placebo|Participants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)
11018907|NCT01147250|EG001|Reported Event|Lixisenatide|Participants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)
11341283|NCT03680105|EG007|Reported Event|Part 2; Placebo|Participants in Part 2 received a saline placebo every day for 7 days.
11018908|NCT01147302|BG000|Baseline|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
11018909|NCT01147302|BG001|Baseline|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
11018910|NCT01147302|BG002|Baseline|Total|Total of all reporting groups
11018911|NCT01147302|FG000|Participant Flow|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
11018912|NCT01147302|FG001|Participant Flow|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
11018913|NCT01147302|OG000|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
11018914|NCT01147302|OG001|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
11018915|NCT01147302|EG000|Reported Event|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
11018916|NCT01147302|EG001|Reported Event|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
11018917|NCT01147341|BG000|Baseline|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
11018918|NCT01147341|BG001|Baseline|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
11018919|NCT01147341|BG002|Baseline|Total|Total of all reporting groups
11018920|NCT01147341|FG000|Participant Flow|Active Treatment With Cimzia|"Reporting group: Cimzia : prefilled 200mg Cimzia syringes. Cimzia 400mg SC at baseline, weeks 2 and 4 and Cimzia 200mg SC at weeks 6, 8, and 10 during the Double Blind Portion.~Cimzia 400mg SC at weeks 12, 14, and 16 and Cimzia 200mg SC at weeks 18, 20, and 22.~27 patients entered the Double Blind Portion."
11018921|NCT01147341|FG001|Participant Flow|Placebo|"Reporting group: Placebo : prefilled saline syringe during the Double Blind Period~10 patients entered"
11018922|NCT01147341|OG000|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
11018923|NCT01147341|OG001|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
11018924|NCT01147341|EG000|Reported Event|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
11018925|NCT01147341|EG001|Reported Event|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
11066191|NCT01390948|FG001|Participant Flow|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks throughout the entire treatment period.
11066192|NCT01390948|FG002|Participant Flow|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
11066193|NCT01390948|OG000|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
11066194|NCT01390948|OG001|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
11066195|NCT01390948|EG000|Reported Event|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
11018926|NCT01147380|BG000|Baseline|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
11018927|NCT01147380|BG001|Baseline|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
11018928|NCT01147380|BG002|Baseline|Total|Total of all reporting groups
11018929|NCT01147380|FG000|Participant Flow|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
11018930|NCT01147380|FG001|Participant Flow|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
11018931|NCT01147380|OG000|Outcome|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
11018932|NCT01147380|OG001|Outcome|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
11018933|NCT01147380|OG000|Outcome|Small Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells( mainly NK cells) is between 10 and 100 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate. Patient of this arm receive small dose of liver NK cell inoculation as described.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
11018934|NCT01147380|OG001|Outcome|Large Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells(mainly NK cells) is between 100 and 1000 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate.Patient of this arm receive large dose of liver NK cell inoculation as described.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
11018935|NCT01147380|EG000|Reported Event|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
11018936|NCT01147380|EG001|Reported Event|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
11018937|NCT01147406|BG000|Baseline|Cohort 1|N6022 - Active 5 mg
11018938|NCT01147406|BG001|Baseline|Cohort 2 & 4|N6022 - Active 15 mg
11018939|NCT01147406|BG002|Baseline|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
11018940|NCT01147406|BG003|Baseline|Cohort 5|N6022 - Active 25 mg
11018941|NCT01147406|BG004|Baseline|Cohort 6|N6022 - Active 35 mg
11018942|NCT01147406|BG005|Baseline|Placebo|Not Active - Placebo
11018943|NCT01147406|BG006|Baseline|Total|Total of all reporting groups
11018944|NCT01147406|FG000|Participant Flow|Cohort 1|5 mg of N6022 was given intravenously daily for 7 days
11018945|NCT01147406|FG001|Participant Flow|Cohorts 2 and 4|15 mg of N6022 was given intravenously daily for 7 days
11018946|NCT01147406|FG002|Participant Flow|Cohort 3|45 mg of N6022 was to be given intravenously daily for 7 days however, the actual amount was 27.5 mg.
11018947|NCT01147406|FG003|Participant Flow|Cohort 5|25 mg of N6022 was given intravenously daily for 7 days
11018948|NCT01147406|FG004|Participant Flow|Cohort 6|35 mg of N6022 was given intravenously daily for 7 days
11018949|NCT01147406|FG005|Participant Flow|Placebo|Not Active - Placebo
11018950|NCT01147406|OG000|Outcome|Cohort 1|N6022 - Active 5 mg
11018951|NCT01147406|OG001|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
11018952|NCT01147406|OG002|Outcome|Cohort 3|N6022 - Active 45 mg
11018953|NCT01147406|OG003|Outcome|Cohort 5|N6022 - Active 25 mg
11018954|NCT01147406|OG004|Outcome|Cohort 6|N6022 - Active 35 mg
11018955|NCT01147406|OG005|Outcome|Placebo|Not Active - Placebo
11018956|NCT01147406|OG002|Outcome|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
11018957|NCT01147406|EG000|Reported Event|Cohort 1|N6022 - Active 5 mg
11018958|NCT01147406|EG001|Reported Event|Cohort 2 and 4|N6022 - Active 15 mg
11018959|NCT01147406|EG002|Reported Event|Cohort 3|N6022 - Active 45 mg
11018960|NCT01147406|EG003|Reported Event|Cohort 5|N6022 - Active 25 mg
11018961|NCT01147406|EG004|Reported Event|Cohort 6|N6022 - Active 35 mg
11018962|NCT01147406|EG005|Reported Event|Placebo|Not Active - Placebo
11018963|NCT01147458|BG000|Baseline|Entire Study Population|Includes groups randomized to receive PF-04191834 first, placebo first, PF-04191834 plus naproxen first, and naproxen first.
11018964|NCT01147458|FG000|Participant Flow|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
11018965|NCT01147458|FG001|Participant Flow|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
11018966|NCT01147458|FG002|Participant Flow|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
11018967|NCT01147458|FG003|Participant Flow|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
11018968|NCT01147458|OG000|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
11018969|NCT01147458|OG001|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
11018970|NCT01147458|OG002|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
11018971|NCT01147458|OG003|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
11018972|NCT01147458|OG000|Outcome|PF-04191834 600 mg BID|PF-04191834 600 mg BID administered either in Period 1 or Period 2
11018973|NCT01147458|OG001|Outcome|PF-04191834 600 mg BID + Naproxen 500 mg BID|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
11018974|NCT01147458|EG000|Reported Event|PF-04191834|PF-04191834 600 mg BID administered either in Period 1 or Period 2
11018975|NCT01147458|EG001|Reported Event|Placebo|Placebo administered either in Period 1 or Period 2
11018976|NCT01147458|EG002|Reported Event|PF-04191834 + Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
11018977|NCT01147458|EG003|Reported Event|Naproxen|Naproxen 500 mg BID administered either in Period 1 or Period 2
11018978|NCT01147471|BG000|Baseline|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
11018979|NCT01147471|BG001|Baseline|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry - after extubation."
11018980|NCT01147471|BG002|Baseline|Total|Total of all reporting groups
11018981|NCT01147471|FG000|Participant Flow|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
11018982|NCT01147471|FG001|Participant Flow|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry - after extubation."
11018983|NCT01147471|OG000|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
11018984|NCT01147471|OG001|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry - after extubation."
11148539|NCT01865448|BG001|Baseline|Omega-3 DHA|"Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.~Omega-3 DHA: Patients take daily 2 tablets of placebo"
11148540|NCT01865448|BG002|Baseline|Total|Total of all reporting groups
11018985|NCT01147471|EG000|Reported Event|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize stove-in segment. Post-operatively, the patients would receive standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.~operative rib fix"
11018986|NCT01147471|EG001|Reported Event|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry - after extubation."
11018987|NCT01147497|BG000|Baseline|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
11018988|NCT01147497|BG001|Baseline|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
11018989|NCT01147497|BG002|Baseline|Total|Total of all reporting groups
11018990|NCT01147497|FG000|Participant Flow|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
11018991|NCT01147497|FG001|Participant Flow|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
11018992|NCT01147497|OG000|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
11018993|NCT01147497|OG001|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
11018994|NCT01147497|EG000|Reported Event|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
11018995|NCT01147497|EG001|Reported Event|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
11018996|NCT01147601|BG000|Baseline|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.~topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
11018997|NCT01147601|BG001|Baseline|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily~Control (placebo) group: Control (placebo) group"
11018998|NCT01147601|BG002|Baseline|Total|Total of all reporting groups
11018999|NCT01147601|FG000|Participant Flow|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.~topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
11019000|NCT01147601|FG001|Participant Flow|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily~Control (placebo) group: Control (placebo) group"
11019001|NCT01147601|OG000|Outcome|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.~topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
11019002|NCT01147601|OG001|Outcome|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily~Control (placebo) group: Control (placebo) group"
11019003|NCT01147601|EG000|Reported Event|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.~topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
11019004|NCT01147601|EG001|Reported Event|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily~Control (placebo) group: Control (placebo) group"
11019005|NCT01147627|BG000|Baseline|Exenatide|
11019006|NCT01147627|BG001|Baseline|Premixed Insulin Analog|
11019007|NCT01147627|BG002|Baseline|Thiazolidinedione|
11019008|NCT01147627|BG003|Baseline|Total|Total of all reporting groups
11019009|NCT01147627|FG000|Participant Flow|Exenatide|5 µg was injected twice-daily subcutaneously increasing to 10 µg twice-daily after 4 weeks. Those who experienced hypoglycaemia frequently or could not tolerate adverse events were instructed to reduce the dose to 5 µg twice-daily.
11019010|NCT01147627|FG001|Participant Flow|Premixed Insulin Analog|Premixed insulin was injected twice-daily commencing with 0.4 IU/kg daily, with 50% given 15 minutes before breakfast and dinner respectively
11019011|NCT01147627|FG002|Participant Flow|Pioglitazone|Pioglitazone was commenced at a dose of 30 mg daily, increasing to 45 mg daily after 4 weeks.
11019012|NCT01147627|OG000|Outcome|Exenatide|
11019013|NCT01147627|OG001|Outcome|Premixed Insulin Analog|
11019014|NCT01147627|OG002|Outcome|Thiazolidinedione|
11019015|NCT01147627|EG000|Reported Event|Exenatide|
11019016|NCT01147627|EG001|Reported Event|Premixed Insulin Analog|
11019017|NCT01147627|EG002|Reported Event|Thiazolidinedione|
11019018|NCT01147640|BG000|Baseline|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
11019019|NCT01147640|BG001|Baseline|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
11019020|NCT01147640|BG002|Baseline|Total|Total of all reporting groups
11019021|NCT01147640|FG000|Participant Flow|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
11019022|NCT01147640|FG001|Participant Flow|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
11019023|NCT01147640|OG000|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
11019024|NCT01147640|OG001|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
11019025|NCT01147640|EG000|Reported Event|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
11019026|NCT01147640|EG001|Reported Event|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
11019027|NCT01147744|BG000|Baseline|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019028|NCT01147744|BG001|Baseline|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019029|NCT01147744|BG002|Baseline|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019030|NCT01147744|BG003|Baseline|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019031|NCT01147744|BG004|Baseline|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019032|NCT01147744|BG005|Baseline|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019033|NCT01147744|BG006|Baseline|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
11019034|NCT01147744|BG007|Baseline|Total|Total of all reporting groups
11019035|NCT01147744|FG000|Participant Flow|Placebo|Participants received two tablets of placebo orally plus one dose of fluticasone propionate (FP) matching placebo twice daily (BID) via dry powder inhaler (DPI) in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally once daily (QD) in evening for the 8-Weeks.
11019036|NCT01147744|FG001|Participant Flow|GSK2190915 10 Milligrams (mg)|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019037|NCT01147744|FG002|Participant Flow|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019038|NCT01147744|FG003|Participant Flow|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019039|NCT01147744|FG004|Participant Flow|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019040|NCT01147744|FG005|Participant Flow|Fluticasone Propionate 100 Microgram (mcg)|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019041|NCT01147744|FG006|Participant Flow|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
11019042|NCT01147744|OG000|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019043|NCT01147744|OG001|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019044|NCT01147744|OG002|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019045|NCT01147744|OG003|Outcome|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019046|NCT01147744|OG004|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11148541|NCT01865448|FG000|Participant Flow|Control|Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
11019047|NCT01147744|OG005|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019048|NCT01147744|OG006|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
11019049|NCT01147744|OG001|Outcome|GSK2190915 10mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019050|NCT01147744|OG002|Outcome|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019051|NCT01147744|OG003|Outcome|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019052|NCT01147744|OG004|Outcome|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019053|NCT01147744|OG006|Outcome|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
11019054|NCT01147744|OG003|Outcome|GSK2190915 10 0mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019055|NCT01147744|EG000|Reported Event|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019056|NCT01147744|EG001|Reported Event|GSK2190915 10mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019057|NCT01147744|EG002|Reported Event|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019058|NCT01147744|EG003|Reported Event|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019059|NCT01147744|EG004|Reported Event|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019060|NCT01147744|EG005|Reported Event|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
11019061|NCT01147744|EG006|Reported Event|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
11019062|NCT01147809|BG000|Baseline|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019063|NCT01147809|BG001|Baseline|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019064|NCT01147809|BG002|Baseline|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019065|NCT01147809|BG003|Baseline|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019066|NCT01147809|BG004|Baseline|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
11019067|NCT01147809|BG005|Baseline|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
11019068|NCT01147809|BG006|Baseline|Total|Total of all reporting groups
11341284|NCT03680105|EG008|Reported Event|Part 2; Cohort 1; RJX|Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX every day for 7 days.
11019069|NCT01147809|FG000|Participant Flow|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019070|NCT01147809|FG001|Participant Flow|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019071|NCT01147809|FG002|Participant Flow|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019072|NCT01147809|FG003|Participant Flow|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019073|NCT01147809|FG004|Participant Flow|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
11019074|NCT01147809|FG005|Participant Flow|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
11019075|NCT01147809|OG000|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019076|NCT01147809|OG001|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019077|NCT01147809|OG002|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019078|NCT01147809|OG003|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019079|NCT01147809|OG000|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
11019080|NCT01147809|OG001|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
11019081|NCT01147809|OG001|Outcome|21-Day Cycle Eltrombopag 100 mg)|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019082|NCT01147809|EG000|Reported Event|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019083|NCT01147809|EG001|Reported Event|Phase I: 21-Day Cycle Eltrombopag|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019084|NCT01147809|EG002|Reported Event|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019085|NCT01147809|EG003|Reported Event|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
11019086|NCT01147809|EG004|Reported Event|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
11019087|NCT01147809|EG005|Reported Event|Phase II: Eltrombopag|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
11019088|NCT01147848|BG000|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
11019089|NCT01147848|BG001|Baseline|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
11019090|NCT01147848|BG002|Baseline|Total|Total of all reporting groups
11019091|NCT01147848|FG000|Participant Flow|Fluticasone Propionate 250 µg BID|Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms.
11019092|NCT01147848|FG001|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
11019093|NCT01147848|FG002|Participant Flow|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
11019094|NCT01147848|OG000|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
11019095|NCT01147848|OG001|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
11019096|NCT01147848|OG000|Outcome|FFluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
11019097|NCT01147848|EG000|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
11019098|NCT01147848|EG001|Reported Event|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
11019099|NCT01147874|BG000|Baseline|All Participants|Participants with psoriasis were observed for 8 weeks.
11019100|NCT01147874|FG000|Participant Flow|All Participants|Participants with psoriasis were observed for 8 weeks.
11019101|NCT01147874|OG000|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
11019102|NCT01147874|EG000|Reported Event|All Participants|Participants with psoriasis were observed for 8 weeks.
11019103|NCT01147900|BG000|Baseline|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019104|NCT01147900|BG001|Baseline|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019105|NCT01147900|BG002|Baseline|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019106|NCT01147900|BG003|Baseline|Total|Total of all reporting groups
11019107|NCT01147900|FG000|Participant Flow|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019108|NCT01147900|FG001|Participant Flow|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019109|NCT01147900|FG002|Participant Flow|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11148542|NCT01865448|FG001|Participant Flow|Omega-3 DHA|"Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.~Omega-3 DHA: Patients take daily 2 tablets of placebo"
11019110|NCT01147900|OG000|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019111|NCT01147900|OG001|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019112|NCT01147900|OG002|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019113|NCT01147900|EG000|Reported Event|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019114|NCT01147900|EG001|Reported Event|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019115|NCT01147900|EG002|Reported Event|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11019116|NCT01147926|BG000|Baseline|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
11019117|NCT01147926|BG001|Baseline|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
11019118|NCT01147926|BG002|Baseline|Total|Total of all reporting groups
11019119|NCT01147926|FG000|Participant Flow|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
11019120|NCT01147926|FG001|Participant Flow|PRUCALOPRIDE|Prucalopride 2 milligram (mg) tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
11019121|NCT01147926|OG000|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
11019122|NCT01147926|OG001|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
11019123|NCT01147926|EG000|Reported Event|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
11019124|NCT01147926|EG001|Reported Event|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to less than <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
11019125|NCT01148017|BG000|Baseline|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
11019126|NCT01148017|BG001|Baseline|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
11019127|NCT01148017|BG002|Baseline|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
11019128|NCT01148017|BG003|Baseline|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
11019129|NCT01148017|BG004|Baseline|Total|Total of all reporting groups
11019130|NCT01148017|FG000|Participant Flow|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
11019131|NCT01148017|FG001|Participant Flow|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
11019132|NCT01148017|FG002|Participant Flow|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
11019133|NCT01148017|FG003|Participant Flow|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
11019134|NCT01148017|OG000|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
11019135|NCT01148017|OG001|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
11019136|NCT01148017|OG002|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
11019137|NCT01148017|OG002|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
11019138|NCT01148017|OG003|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
11019139|NCT01148017|EG000|Reported Event|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
11019140|NCT01148017|EG001|Reported Event|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
11019141|NCT01148017|EG002|Reported Event|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
11019142|NCT01148017|EG003|Reported Event|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
11019143|NCT01148225|BG000|Baseline|Adalimumab|Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
11019144|NCT01148225|FG000|Participant Flow|Adalimumab|Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
11019145|NCT01148225|OG000|Outcome|Adalimumab|Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
11019146|NCT01148225|OG000|Outcome|Adalimumab|Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
11019147|NCT01148225|OG000|Outcome|Adalimumab|Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
11019148|NCT01148225|OG000|Outcome|Adalimumab|"Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.~adalimumab: Adalimumab, pre-filled syringe, administered by SC injection"
11019149|NCT01148225|EG000|Reported Event|Adalimumab|Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
11019150|NCT01148420|BG000|Baseline|DMPA + MPA|
11019151|NCT01148420|FG000|Participant Flow|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
11019152|NCT01148420|OG000|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
11019153|NCT01148420|OG000|Outcome|DMPA + MPA|
11019154|NCT01148420|EG000|Reported Event|DMPA & High Dose MPA|DMPA & High Dose MPA
11019155|NCT01148459|BG000|Baseline|GSK257049 Group|Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
11019156|NCT01148459|BG001|Baseline|Verorab Group|Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
11019157|NCT01148459|BG002|Baseline|Total|Total of all reporting groups
11019158|NCT01148459|FG000|Participant Flow|GSK257049 Group|Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
11019159|NCT01148459|FG001|Participant Flow|Verorab Group|Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
11019160|NCT01148459|OG000|Outcome|GSK257049 Group|Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
11019161|NCT01148459|OG001|Outcome|Verorab Group|Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
11148543|NCT01865448|OG000|Outcome|Control|Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
11341285|NCT03680105|EG009|Reported Event|Part 2; Cohort 2; RJX or Placebo|Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX every day for 7 days.
11019162|NCT01148459|EG000|Reported Event|GSK257049 Group|Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
11019163|NCT01148459|EG001|Reported Event|Verorab Group|Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
11019164|NCT01148511|BG000|Baseline|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
11019165|NCT01148511|BG001|Baseline|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
11019166|NCT01148511|BG002|Baseline|Total|Total of all reporting groups
11019167|NCT01148511|FG000|Participant Flow|All Patients|All 99 patients were exposed to study drug. 93 of the 99 patients were randomized into the Treat and Extend and the Treat and Observe treatment groups.
11019168|NCT01148511|FG001|Participant Flow|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
11019169|NCT01148511|FG002|Participant Flow|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
11019170|NCT01148511|OG000|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
11019171|NCT01148511|OG001|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
11019172|NCT01148511|EG000|Reported Event|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
11019173|NCT01148511|EG001|Reported Event|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
11019174|NCT01148511|EG002|Reported Event|Before Randomization|These 6 patients were exposed to study drug but discontinued from the study prior to randomization.
11019175|NCT01148524|BG000|Baseline|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
11019176|NCT01148524|BG001|Baseline|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
11019177|NCT01148524|BG002|Baseline|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
11019178|NCT01148524|BG003|Baseline|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
11019179|NCT01148524|BG004|Baseline|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
11019180|NCT01148524|BG005|Baseline|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
11019181|NCT01148524|BG006|Baseline|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
11019182|NCT01148524|BG007|Baseline|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
11019183|NCT01148524|BG008|Baseline|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
11019184|NCT01148524|BG009|Baseline|Total|Total of all reporting groups
11019185|NCT01148524|FG000|Participant Flow|rMenB06|Subjects who had received 2 doses each of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB+OMV-NZ) (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
11019186|NCT01148524|FG001|Participant Flow|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
11019187|NCT01148524|FG002|Participant Flow|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
11019188|NCT01148524|FG003|Participant Flow|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
11019189|NCT01148524|FG004|Participant Flow|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
11019190|NCT01148524|FG005|Participant Flow|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
11019191|NCT01148524|FG006|Participant Flow|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
11019192|NCT01148524|FG007|Participant Flow|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
11019193|NCT01148524|FG008|Participant Flow|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
11019194|NCT01148524|OG000|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
11019195|NCT01148524|OG001|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
11019196|NCT01148524|OG002|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
11019197|NCT01148524|OG003|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
11019198|NCT01148524|OG004|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
11019199|NCT01148524|OG005|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
11019200|NCT01148524|OG006|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
11019201|NCT01148524|OG007|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
11019202|NCT01148524|OG008|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
11019203|NCT01148524|EG000|Reported Event|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
11019204|NCT01148524|EG001|Reported Event|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
11019205|NCT01148524|EG002|Reported Event|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
11019206|NCT01148524|EG003|Reported Event|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
11019207|NCT01148524|EG004|Reported Event|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
11019208|NCT01148524|EG005|Reported Event|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
11019209|NCT01148524|EG006|Reported Event|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
11019210|NCT01148524|EG007|Reported Event|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
11019211|NCT01148524|EG008|Reported Event|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
11019212|NCT01148537|BG000|Baseline|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
11019213|NCT01148537|BG001|Baseline|Placebo|Matching placebo transdermal patches.
11019214|NCT01148537|BG002|Baseline|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
11019215|NCT01148537|BG003|Baseline|Total|Total of all reporting groups
11019216|NCT01148537|FG000|Participant Flow|BTDS|"Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. Randomization was from predose on day 1 to predose on day 14. There were 3 treatment groups: BTDS, placebo, and moxifloxacin as the positive control. The treatment groups between placebo and BTDS were double-blinded. Moxifloxacin treatment was open label to subjects, to the investigator, and the staff at the study site.~BTDS or placebo TDS was applied on day 1 for 3 days (BTDS 5), on day 4 for 3 days (BTDS 10), on day 7 for 3 days (BTDS 20), and on day 10 for 4 days (2 * BTDS 20). On day 6 and day 13, subjects in the positive control group received one 400 mg tablet of moxifloxacin."
11019217|NCT01148537|FG001|Participant Flow|Placebo|Matching placebo transdermal patches.
11019218|NCT01148537|FG002|Participant Flow|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
11019219|NCT01148537|OG000|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
11019220|NCT01148537|OG001|Outcome|Placebo|Matching placebo transdermal patches.
11019221|NCT01148537|OG000|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
11019222|NCT01148537|OG000|Outcome|Mofloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
11019223|NCT01148537|EG000|Reported Event|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
11019224|NCT01148537|EG001|Reported Event|Placebo|Matching placebo transdermal patches.
11019225|NCT01148537|EG002|Reported Event|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
11019226|NCT01148563|BG000|Baseline|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
11019227|NCT01148563|BG001|Baseline|Tele-health Monitoring Group|The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.
11019228|NCT01148563|BG002|Baseline|Total|Total of all reporting groups
11019229|NCT01148563|FG000|Participant Flow|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
11019230|NCT01148563|FG001|Participant Flow|Tele-health Monitoring Group|The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.
11019231|NCT01148563|OG000|Outcome|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
11019232|NCT01148563|OG001|Outcome|Tele-health Monitoring Group|The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.
11019233|NCT01148563|OG001|Outcome|Tele-health Monitoring Group|"The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.~Tele-health Monitoring: Daily tele-health monitoring data will be collected from randomized participants."
11019234|NCT01148563|EG000|Reported Event|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
11019235|NCT01148563|EG001|Reported Event|Tele-health Monitoring Group|The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.
11019236|NCT01148693|BG000|Baseline|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
11019237|NCT01148693|BG001|Baseline|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
11019238|NCT01148693|BG002|Baseline|Total|Total of all reporting groups
11019239|NCT01148693|FG000|Participant Flow|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
11019240|NCT01148693|FG001|Participant Flow|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
11019241|NCT01148693|OG000|Outcome|Gentamicin|patients for whom 10m/10cc of gentamicin is added to contrast during ERCP
11019242|NCT01148693|OG001|Outcome|Placebo|patients for whom distilled water is added to contrast during ERCP
11019243|NCT01148693|EG000|Reported Event|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
11019244|NCT01148693|EG001|Reported Event|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
11019245|NCT01148745|BG000|Baseline|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
11019246|NCT01148745|FG000|Participant Flow|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
11019247|NCT01148745|OG000|Outcome|Ferumoxytol|All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
11019248|NCT01148745|OG000|Outcome|Ferumoxytol 510 mg|2 doses of 510 mg IV over 17 seconds separated by 3 days
11019249|NCT01148745|OG000|Outcome|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
11019250|NCT01148745|EG000|Reported Event|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
11019251|NCT01148771|BG000|Baseline|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
11019252|NCT01148771|BG001|Baseline|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
11019253|NCT01148771|BG002|Baseline|Total|Total of all reporting groups
11019254|NCT01148771|FG000|Participant Flow|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
11019255|NCT01148771|FG001|Participant Flow|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
11019256|NCT01148771|OG000|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
11019257|NCT01148771|OG001|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
11019258|NCT01148771|OG000|Outcome|Ertapenem IV 5 Minute Bolus|
11019259|NCT01148771|OG001|Outcome|Ertapenem IV 30 Minute Infusion|
11019260|NCT01148771|OG000|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 5 minute IV bolus.
11019261|NCT01148771|OG001|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 30 minute IV infusion.
11019262|NCT01148771|EG000|Reported Event|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
11019263|NCT01148771|EG001|Reported Event|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
11019264|NCT01148810|BG000|Baseline|BAF312/BAF312|2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019265|NCT01148810|BG001|Baseline|Placebo/BAF312|2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019266|NCT01148810|BG002|Baseline|Total|Total of all reporting groups
11019267|NCT01148810|FG000|Participant Flow|BAF312/BAF312|2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019268|NCT01148810|FG001|Participant Flow|Placebo/BAF312|2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019269|NCT01148810|OG000|Outcome|BAF312/BAF312|2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019270|NCT01148810|OG001|Outcome|Placebo/BAF312|2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019271|NCT01148810|OG000|Outcome|BAF312|2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019272|NCT01148810|EG000|Reported Event|BAF312/BAF312|2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019273|NCT01148810|EG001|Reported Event|Placebo/BAF312|2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
11019274|NCT01148836|BG000|Baseline|Healthy Controls Subjects|
11019275|NCT01148836|BG001|Baseline|Pulmonary Hypertension Subjects|
11019276|NCT01148836|BG002|Baseline|Total|Total of all reporting groups
11019277|NCT01148836|FG000|Participant Flow|Healthy Controls|
11019278|NCT01148836|FG001|Participant Flow|Pulmonary Hypertension Subjects (Disease)|
11019279|NCT01148836|OG000|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
11019280|NCT01148836|OG001|Outcome|Normal Controls|Normal controls taking Co-Q for three months
11019281|NCT01148836|EG000|Reported Event|Coenzyme Q and Pulmonary Hypertension|Pulmonary Hypertension subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
11019282|NCT01148836|EG001|Reported Event|Coenzyme Q and Healthy Controls|Healthy Control subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
11019283|NCT01148862|BG000|Baseline|Entire Study Population|Includes groups randomized to LGS on first and LGS off first
11019284|NCT01148862|FG000|Participant Flow|LGS on First, Then LGS Off|LGS on first, then LGS off group will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature turned 'ON' first, then LGS turned 'OFF' after crossing over
11019285|NCT01148862|FG001|Participant Flow|LGS Off First, Then LGS on|LGS off first, then LGS on group will wear the MiniMed Paradigm® X54 System with Low Glucose Suspend (LGS) turned 'OFF' first, then LGS turned on 'ON' after crossing over
11019286|NCT01148862|OG000|Outcome|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
11019287|NCT01148862|OG001|Outcome|LGS Off: Without Low Glucose Suspend (LGS) Feature|LGS off: Without Low Glucose Suspend (LGS) feature
11019288|NCT01148862|EG000|Reported Event|LGS Off: Without Low Glucose Suspend (LGS) Feature|
11019289|NCT01148862|EG001|Reported Event|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|
11019290|NCT01148940|BG000|Baseline|White|self-described
11019291|NCT01148940|BG001|Baseline|Black|self-described
11019292|NCT01148940|BG002|Baseline|Total|Total of all reporting groups
11019293|NCT01148940|FG000|Participant Flow|White Women With HbAA|White pregnant and post partum women with Hb AA
11019294|NCT01148940|FG001|Participant Flow|Black Women With Hb AA|Black pregnant and post partum women with HbAA
11019295|NCT01148940|FG002|Participant Flow|Black Women With SCT|Black pregnant and postpartum women with HbAS
11019296|NCT01148940|OG000|Outcome|White Women With HbAA|White women pregnant and postpartum with HbAA
11019297|NCT01148940|OG001|Outcome|Black Women With HbAA|Black women pregnant and postpartum with HbAA
11019298|NCT01148940|OG002|Outcome|Black Women With SCT|Black women pregnant and postpartum with HbAS
11019299|NCT01148940|EG000|Reported Event|White Women With HbAA|White pregnant/postpartum women with HbAA
11019300|NCT01148940|EG001|Reported Event|Black Women With HbAA|black pregnant/postpartum women with HbAA
11019301|NCT01148940|EG002|Reported Event|Black Women With SCT|black women with HbAS
11019302|NCT01148979|BG000|Baseline|Placebo, Then Vyvanse|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
11019303|NCT01148979|BG001|Baseline|Vyvanse, Then Placebo|"Participants first received Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
11019304|NCT01148979|BG002|Baseline|Total|Total of all reporting groups
11019305|NCT01148979|FG000|Participant Flow|Placebo, Then Vyvanse|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
11019306|NCT01148979|FG001|Participant Flow|Vyvanse, Then Placebo|"Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
11019307|NCT01148979|OG000|Outcome|Placebo Adjunct|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
11019308|NCT01148979|OG001|Outcome|Lisdexamfetamine Dimesylate (Vyvanse)|"Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
11019309|NCT01148979|EG000|Reported Event|Adjunct Lisdexamfetamine (Vyvanse)|"Participants receive Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg."
11019310|NCT01148979|EG001|Reported Event|Adjunct Placebo|"Participants receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they receive Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
11019311|NCT01149057|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
11019312|NCT01149057|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) intravenous (IV) infusion every 4 weeks for a period of 96 weeks.
11019313|NCT01149057|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
11019314|NCT01149057|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
11019315|NCT01149096|BG000|Baseline|Arm I (Conventional Bone Marrow Harvest)|"Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Laboratory Biomarker Analysis: Optional correlative studies"
11019316|NCT01149096|BG001|Baseline|Arm II (Filgrastim, Bone Marrow Harvest)|"Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Filgrastim: Given subcutaneously~Laboratory Biomarker Analysis: Optional correlative studies"
11019317|NCT01149096|BG002|Baseline|Total|Total of all reporting groups
11019318|NCT01149096|FG000|Participant Flow|Arm I (Conventional Bone Marrow Harvest)|"Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Laboratory Biomarker Analysis: Optional correlative studies"
11019319|NCT01149096|FG001|Participant Flow|Arm II (Filgrastim, Bone Marrow Harvest)|"Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Filgrastim: Given subcutaneously~Laboratory Biomarker Analysis: Optional correlative studies"
11019320|NCT01149096|OG000|Outcome|Arm II (Filgrastim, Bone Marrow Harvest)|"Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Filgrastim: Given subcutaneously~Laboratory Biomarker Analysis: Optional correlative studies"
11019321|NCT01149096|OG000|Outcome|Arm I (Conventional Bone Marrow Harvest)|"Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Laboratory Biomarker Analysis: Optional correlative studies"
11019322|NCT01149096|OG001|Outcome|Arm II (Filgrastim, Bone Marrow Harvest)|"Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Filgrastim: Given subcutaneously~Laboratory Biomarker Analysis: Optional correlative studies"
11019323|NCT01149096|EG000|Reported Event|Arm I (Conventional Bone Marrow Harvest)|"Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Laboratory Biomarker Analysis: Optional correlative studies"
11019324|NCT01149096|EG001|Reported Event|Arm II (Filgrastim, Bone Marrow Harvest)|"Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.~Bone Marrow Donation: Undergo bone marrow harvest~Filgrastim: Given subcutaneously~Laboratory Biomarker Analysis: Optional correlative studies"
11019325|NCT01149148|BG000|Baseline|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
11019326|NCT01149148|BG001|Baseline|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
11019327|NCT01149148|BG002|Baseline|Total|Total of all reporting groups
11019328|NCT01149148|FG000|Participant Flow|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
11019329|NCT01149148|FG001|Participant Flow|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
11019330|NCT01149148|OG000|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
11019331|NCT01149148|OG001|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
11019332|NCT01149148|OG000|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|At the start of surgery two sensor pads will be placed on the patients forehead and attached to the INVOS Monitoring System. If the rSO2 values decrease >20% from baseline or decline below 50 the anesthesiologist will initiate an intervention: Increase mean arterial pressure, check head and cannula position, increase pump flow, increase systemic oxygenation, increase PaCo2 >45, increase anesthetic depth by increaseing volatile anesthetic or administering propoful boluses, consider PRBC transfusion for Hct<21%.
11019333|NCT01149148|EG000|Reported Event|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
11019334|NCT01149148|EG001|Reported Event|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
11019335|NCT01149343|BG000|Baseline|GSK2302025A Cohort 1|Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019336|NCT01149343|BG001|Baseline|GSK2302025A Cohort 2|Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019337|NCT01149343|BG002|Baseline|GSK2302025A Cohort 3|Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019338|NCT01149343|BG003|Baseline|GSK2302025A Cohort 4|In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
11019339|NCT01149343|BG004|Baseline|Total|Total of all reporting groups
11019340|NCT01149343|FG000|Participant Flow|GSK2302025A Cohort 1|Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019341|NCT01149343|FG001|Participant Flow|GSK2302025A Cohort 2|Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019342|NCT01149343|FG002|Participant Flow|GSK2302025A Cohort 3|Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019343|NCT01149343|FG003|Participant Flow|GSK2302025A Cohort 4|In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
11019344|NCT01149343|OG000|Outcome|GSK2302025A Cohort 1|Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019345|NCT01149343|OG001|Outcome|GSK2302025A Cohort 2|Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019346|NCT01149343|OG002|Outcome|GSK2302025A Cohort 3|Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019347|NCT01149343|OG003|Outcome|GSK2302025A Cohort 4|In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
11019348|NCT01149343|OG000|Outcome|GSK2302025A Cohort 1|Subjects will receive investigational dose-level A (different from dose-levels B and C). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
11019349|NCT01149343|OG001|Outcome|GSK2302025A Cohort 2|Subjects will receive investigational dose-level B (different from dose-levels A and C). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
11019350|NCT01149343|OG002|Outcome|GSK2302025A Cohort 3|Subjects will receive investigational dose-level C (different from dose-levels A and B). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
11019351|NCT01149343|OG003|Outcome|GSK2302025A Cohort 4|In Phase 2 of the study subjects will receive the optimal investigational dose-level identified in Phase 1. Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
11148544|NCT01865448|OG001|Outcome|Omega-3 DHA|"Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.~Omega-3 DHA: Patients take daily 2 tablets of placebo"
11148545|NCT01865448|OG000|Outcome|Control|Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programmebo
11148546|NCT01865448|EG000|Reported Event|Control|Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
11148547|NCT01865448|EG001|Reported Event|Omega-3 DHA|"Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.~Omega-3 DHA: Patients take daily 2 tablets of placebo"
11148548|NCT01865487|BG000|Baseline|2-Dose Placebo|Placebo, QFT Neg and Pos, 2 doses day 0 and 56
11148549|NCT01865487|BG001|Baseline|2-Dose 5/500 H56/IC31nmol|5/500 H56ug/IC31nmol, QFT Neg and Pos, 2 Doses, days 0 and 56
11148550|NCT01865487|BG002|Baseline|2-Dose 15/500 H56/IC31nmol|15/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
11148551|NCT01865487|BG003|Baseline|2-Dose 50/500 H56/IC31nmol|50/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
11148552|NCT01865487|BG004|Baseline|3-Dose Placebo|Placebo QFT Neg and Pos, 3 Doses, days 0, 56, 112
11148553|NCT01865487|BG005|Baseline|3-Dose 5/500 H56/IC31nmol|5/500 H56ug/IC31nmol, QFT Neg and Pos, 3 Doses, days 0, 56, 112
11148554|NCT01865487|BG006|Baseline|Total|Total of all reporting groups
11148555|NCT01865487|FG000|Participant Flow|Group 1: 2-dose 5/500|5/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
11148556|NCT01865487|FG001|Participant Flow|Group 1: 2-dose 15/500|15/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
11148557|NCT01865487|FG002|Participant Flow|Group 1: 2-dose 50/500|50/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
11148558|NCT01865487|FG003|Participant Flow|Group 1: 2-dose Placebo|Placebo, QFT Negative, 2 doses, days 0 and 56
11148559|NCT01865487|FG004|Participant Flow|Group 2: 3-dose 5/500|5/500 H56ug/IC31nmol, QFT Negative, 3 doses, days 0, 56, 112
11148560|NCT01865487|FG005|Participant Flow|Group 2: 3-dose Placebo|Placebo, QFT Negative, 3 doses, days 0, 56, 112
11148561|NCT01865487|FG006|Participant Flow|Group 3: 2-dose 5/500|5/500 H56ug/IC31nmol, QFT Positive, 2 doses, Days 0 and 56
11148562|NCT01865487|FG007|Participant Flow|Group 3: 2-dose Placebo|Placebo, QFT Positive, 2 doses, Days 0 and 56
11148563|NCT01865487|FG008|Participant Flow|Group 4: 3-dose 5/500|5/500 H56ug/IC31nmol, QFT Positive, 3 doses, days 0, 56, 112
11148564|NCT01865487|FG009|Participant Flow|Group 4: 3-dose Placebo|Placebo, QFT positive, 3 doses, Days 0, 56, 112
11148565|NCT01865487|OG000|Outcome|Placebo QFT Neg|2-doses and 3-doses (Groups 1 and 2)
11148566|NCT01865487|OG001|Outcome|Placebo QFT Pos|2-doses and 3-doses (Groups 3 and 4)
11148567|NCT01865487|OG002|Outcome|2-Doses 5/500 QFT Neg|QFT Negative (Group 1)
11148568|NCT01865487|OG003|Outcome|2-Doses 15/500|QFT Negative (Group 1)
11148569|NCT01865487|OG004|Outcome|2-Doses 50/500|QFT Negative (Group 1)
11148570|NCT01865487|OG005|Outcome|3-Doses 5/500 QFT Neg|QFT Negative (Group 2)
11148571|NCT01865487|OG006|Outcome|2-Doses 5/500 QFT Pos|QFT Positive (Group 3)
11148572|NCT01865487|OG007|Outcome|3-Doses 5/500 QFT Pos|QFT Positive (Group 4)
11148573|NCT01865487|OG000|Outcome|2-Dose Placebo|Placebo, QFT Neg and Pos, 2 doses day 0 and 56
11148574|NCT01865487|OG001|Outcome|2-Dose 5/500 H56/IC31nmol|5/500 H56ug/IC31nmol, QFT Neg and Pos, 2 Doses, days 0 and 56
11148575|NCT01865487|OG002|Outcome|2-Dose 15/500 H56/IC31nmol|15/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
11148576|NCT01865487|OG003|Outcome|2-Dose 50/500 H56/IC31nmol|50/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
11148577|NCT01865487|OG004|Outcome|3-Dose Placebo|Placebo QFT Neg and Pos, 3 Doses, days 0, 56, 112
11148578|NCT01865487|OG005|Outcome|3-Dose 5/500 H56/IC31nmol|5/500 H56ug/IC31nmol, QFT Neg and Pos, 3 Doses, days 0, 56, 112
11148579|NCT01865487|OG002|Outcome|3-Dose Placebo|Placebo QFT Neg and Pos, 3 Doses, days 0, 56, 112
11148580|NCT01865487|OG003|Outcome|3-Dose 5/500 H56/IC31nmol|5/500 H56ug/IC31nmol, QFT Neg and Pos, 3 Doses, days 0, 56, 112
11148581|NCT01865487|OG001|Outcome|2-Doses 5/500 QFT Neg|QFT Negative (Group 1)
11148582|NCT01865487|OG002|Outcome|2-Doses 15/500|QFT Negative (Group 1)
11148583|NCT01865487|OG003|Outcome|2-Doses 50/500|QFT Negative (Group 1)
11148584|NCT01865487|OG004|Outcome|3-Doses 5/500 QFT Neg|QFT Negative (Group 2)
11148585|NCT01865487|EG000|Reported Event|2-Dose Placebo|Placebo QFT neg and pos
11148586|NCT01865487|EG001|Reported Event|2-Dose 5/500 H56ug/IC31nmol|2-Dose 5/500 H56ug/IC31nmol, QFT neg and pos
11148587|NCT01865487|EG002|Reported Event|2-Dose 15/500 H56ug/IC31nmol|2-Dose 15/500 H56ug/IC31nmol, QFT negative
11148588|NCT01865487|EG003|Reported Event|2-Dose 50/500 H56ug/IC31nmol|2-Dose 50/500 H56ug/IC31nmol, QFT negative
11148589|NCT01865487|EG004|Reported Event|3-Dose Placebo|3-Dose Placebo QFT neg and pos
11148590|NCT01865487|EG005|Reported Event|3-Dose 5/500 H56ug/IC31nmol|3-Dose 5/500 H56ug/IC31nmol, QFT neg and pos
11148591|NCT01865552|BG000|Baseline|SB4 and EU Sourced Enbrel in Part A|"SB4 followed by EU sourced Enbrel~SB4: SC administration~EU sourced Enbrel: SC administration"
11148592|NCT01865552|BG001|Baseline|EU Sourced Enbrel and SB4 in Part A|"EU sourced Enbrel followed by SB4~SB4: SC administration~EU sourced Enbrel: SC administration"
11148593|NCT01865552|BG002|Baseline|SB4 and US Sourced Enbrel in Part B|"SB4 followed by US sourced Enbrel~SB4: SC administration~US sourced Enbrel: SC administration"
11019352|NCT01149343|EG000|Reported Event|GSK2302025A Cohort 1|Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019353|NCT01149343|EG001|Reported Event|GSK2302025A Cohort 2|Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019354|NCT01149343|EG002|Reported Event|GSK2302025A Cohort 3|Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
11019355|NCT01149343|EG003|Reported Event|GSK2302025A Cohort 4|In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
11019356|NCT01149369|BG000|Baseline|Aprepitant|"Aprepitant 125 mg per day~Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks"
11019357|NCT01149369|BG001|Baseline|Aprepitant-placebo|"Placebo aprepitant 125mg per day~Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks"
11019358|NCT01149369|BG002|Baseline|Total|Total of all reporting groups
11019359|NCT01149369|FG000|Participant Flow|Aprepitant|"Aprepitant 125 mg per day~Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks"
11019360|NCT01149369|FG001|Participant Flow|Aprepitant-placebo|"Placebo aprepitant 125mg per day~Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks"
11019361|NCT01149369|OG000|Outcome|Aprepitant|"Aprepitant 125 mg per day~Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks"
11019362|NCT01149369|OG001|Outcome|Aprepitant-placebo|"Placebo aprepitant 125mg per day~Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks"
11019363|NCT01149369|EG000|Reported Event|Aprepitant|"Aprepitant 125 mg per day~Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks"
11019364|NCT01149369|EG001|Reported Event|Aprepitant-placebo|"Placebo aprepitant 125mg per day~Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks"
11019365|NCT01149421|BG000|Baseline|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
11019366|NCT01149421|BG001|Baseline|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
11019367|NCT01149421|BG002|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
11019368|NCT01149421|BG003|Baseline|Total|Total of all reporting groups
11019369|NCT01149421|FG000|Participant Flow|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
11019370|NCT01149421|FG001|Participant Flow|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
11019371|NCT01149421|FG002|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
11019372|NCT01149421|OG000|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
11019373|NCT01149421|OG001|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
11019374|NCT01149421|OG002|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
11019375|NCT01149421|EG000|Reported Event|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
11019376|NCT01149421|EG001|Reported Event|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
11019377|NCT01149421|EG002|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
11019378|NCT01149434|BG000|Baseline|Pharmacokinetic Arm - Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus."
11019379|NCT01149434|BG001|Baseline|Pharmacokinetic Arm-Phase II|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
11019380|NCT01149434|BG002|Baseline|Total|Total of all reporting groups
11148594|NCT01865552|BG003|Baseline|US Sourced Enbrel and SB4 in Part B|"US sourced Enbrel followed by SB4~SB4: SC administration~US sourced Enbrel: SC administration"
11148595|NCT01865552|BG004|Baseline|EU and US Sourced Enbrel in Part C|"EU sourced Enbrel followed by US sourced Enbrel~EU sourced Enbrel: SC administration~US sourced Enbrel: SC administration"
11019381|NCT01149434|FG000|Participant Flow|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
11019382|NCT01149434|FG001|Participant Flow|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
11019383|NCT01149434|OG000|Outcome|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
11019384|NCT01149434|OG000|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
11019385|NCT01149434|OG000|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
11019386|NCT01149434|EG000|Reported Event|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
11019387|NCT01149434|EG001|Reported Event|Pharmacodynamic Arm|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
11019388|NCT01149460|BG000|Baseline|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
11019389|NCT01149460|BG001|Baseline|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
11019390|NCT01149460|BG002|Baseline|Total|Total of all reporting groups
11019391|NCT01149460|FG000|Participant Flow|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
11019392|NCT01149460|FG001|Participant Flow|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
11019393|NCT01149460|OG000|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
11019394|NCT01149460|OG001|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
11019395|NCT01149460|EG000|Reported Event|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
11019396|NCT01149460|EG001|Reported Event|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
11019397|NCT01149473|BG000|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
11019398|NCT01149473|BG001|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
11019399|NCT01149473|BG002|Baseline|Total|Total of all reporting groups
11019400|NCT01149473|FG000|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
11019401|NCT01149473|FG001|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
11019402|NCT01149473|OG000|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
11019403|NCT01149473|OG001|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
11019404|NCT01149473|EG000|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
11019405|NCT01149473|EG001|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
11019406|NCT01149486|BG000|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
11019407|NCT01149486|BG001|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
11019408|NCT01149486|BG002|Baseline|Total|Total of all reporting groups
11019409|NCT01149486|FG000|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
11019410|NCT01149486|FG001|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
11019411|NCT01149486|OG000|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
11019412|NCT01149486|OG001|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
11019413|NCT01149486|EG000|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
11019414|NCT01149486|EG001|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
11019415|NCT01149512|BG000|Baseline|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
11019416|NCT01149512|FG000|Participant Flow|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
11019417|NCT01149512|OG000|Outcome|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
11019418|NCT01149512|EG000|Reported Event|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
11019419|NCT01149538|BG000|Baseline|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
11019420|NCT01149538|BG001|Baseline|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
11019421|NCT01149538|BG002|Baseline|Total|Total of all reporting groups
11019422|NCT01149538|FG000|Participant Flow|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
11019423|NCT01149538|FG001|Participant Flow|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
11019424|NCT01149538|OG000|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
11019425|NCT01149538|OG001|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
11019426|NCT01149538|EG000|Reported Event|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
11019427|NCT01149538|EG001|Reported Event|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
11019428|NCT01149616|BG000|Baseline|Intervention|"Dexamethasone 8mg iv x 1~Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
11019429|NCT01149616|BG001|Baseline|Placebo|"placebo~placebo: placebo administered IV x1"
11019430|NCT01149616|BG002|Baseline|Total|Total of all reporting groups
11019431|NCT01149616|FG000|Participant Flow|Intervention|"Dexamethasone 8mg iv x 1~Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
11019432|NCT01149616|FG001|Participant Flow|Placebo|"placebo~placebo: placebo administered IV x1"
11019433|NCT01149616|OG000|Outcome|Intervention|"Dexamethasone 8mg iv x 1~Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
11019434|NCT01149616|OG001|Outcome|Placebo|"placebo~placebo: placebo administered IV x1"
11019435|NCT01149616|OG000|Outcome|Intervention|Dexamethasone 8mg iv x 1
11019436|NCT01149616|OG001|Outcome|Placebo|placebo: 2 ml normal saline IV x1
11019437|NCT01149616|EG000|Reported Event|Intervention|"Dexamethasone 8mg iv x 1~Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
11019438|NCT01149616|EG001|Reported Event|Placebo|"placebo~placebo: placebo administered 2 ml normal saline IV x1"
11019439|NCT01149655|BG000|Baseline|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
11019440|NCT01149655|BG001|Baseline|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
11019441|NCT01149655|BG002|Baseline|Total|Total of all reporting groups
11019442|NCT01149655|FG000|Participant Flow|Aripiprazole-Conversion Phase|Participants who had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
11019443|NCT01149655|FG001|Participant Flow|Aripiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
11019444|NCT01149655|FG002|Participant Flow|Aripiprazole-Double Blind (DB) Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
11019445|NCT01149655|FG003|Participant Flow|Aripiprazole-Placebo-DB Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
11019446|NCT01149655|OG000|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
11019447|NCT01149655|OG001|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
11019448|NCT01149655|EG000|Reported Event|Aripiprazole-Conversion Phase|Participants had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
11019449|NCT01149655|EG001|Reported Event|Arpiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
11019450|NCT01149655|EG002|Reported Event|Aripiprazole-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
11019451|NCT01149655|EG003|Reported Event|Placebo-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
11019452|NCT01149681|BG000|Baseline|Aplidin®|"APLIDIN (plitidepsin): Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule).~Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four weeks for a maximum period of 6 cycles."
11019453|NCT01149681|FG000|Participant Flow|Aplidin®|"APLIDIN (plitidepsin): Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule).~Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four weeks for a maximum period of 6 cycles."
11019454|NCT01149681|OG000|Outcome|Arm One|"APLIDIN (plitidepsin): Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule).~Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four weeks for a maximum period of 6 cycles."
11019455|NCT01149681|OG000|Outcome|Aplidin®|"APLIDIN (plitidepsin): Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule).~Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four weeks for a maximum period of 6 cycles."
11019456|NCT01149681|EG000|Reported Event|Aplidin®|"APLIDIN (plitidepsin): Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule).~Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four weeks for a maximum period of 6 cycles."
11019457|NCT01149733|BG000|Baseline|Tamsulosin|0.4 mg Capsule
11019458|NCT01149733|BG001|Baseline|Flomax®|0.4 mg Capsule
11019459|NCT01149733|BG002|Baseline|Total|Total of all reporting groups
11019460|NCT01149733|FG000|Participant Flow|Tamsulosin|0.4 mg Capsule
11019461|NCT01149733|FG001|Participant Flow|Flomax®|0.4 mg Capsule
11019462|NCT01149733|OG000|Outcome|Tamsulosin|0.4 mg Capsule
11019463|NCT01149733|OG001|Outcome|Flomax®|0.4 mg Capsule
11019464|NCT01149733|EG000|Reported Event|Tamsulosin|0.4 mg Capsule
11019465|NCT01149733|EG001|Reported Event|Flomax®|0.4 mg Capsule
11019466|NCT01149759|BG000|Baseline|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
11019467|NCT01149759|FG000|Participant Flow|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
11019468|NCT01149759|OG000|Outcome|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
11019469|NCT01149759|EG000|Reported Event|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
11019470|NCT01149772|BG000|Baseline|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. After completion of the active treatment sessions, the participant will receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. Each active treatment session lasts 30 - 40 minutes and the booster calls last 10 - 15 minute.
11019471|NCT01149772|BG001|Baseline|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
11019472|NCT01149772|BG002|Baseline|Total|Total of all reporting groups
11019473|NCT01149772|FG000|Participant Flow|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
11348881|NCT04140890|OG000|Outcome|Control|Participants in the control group will receive newsletters focused on general healthy aging topics over 12 weeks. With the exception of two, 1-page handouts covering PA and dietary recommendations, the weekly content will not overlap with the treatment content. Within 4 days of mailing the newsletter, a trained research assistant (RA) will call the participant, verify receipt of the newsletter, and ask them if they have any questions about the materials. The phone call will last ~15 minutes. Control condition participants receive no further intervention.
11019474|NCT01149772|FG001|Participant Flow|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
11019475|NCT01149772|OG000|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
11019476|NCT01149772|OG001|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
11019477|NCT01149772|OG000|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
11019478|NCT01149772|OG001|Outcome|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
11019479|NCT01149772|EG000|Reported Event|ACCESS|ACCESS: Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completing core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
11019480|NCT01149772|EG001|Reported Event|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
11019481|NCT01149785|BG000|Baseline|Entire Study Population|Includes participants randomized to receive Crizotinib 150 mg IRT first and then Crizotinib 150 mg + Ketoconazole 200 mg BID
11019482|NCT01149785|FG000|Participant Flow|Crizotinib 150 mg|Single oral dose of crizotinib 150 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
11019483|NCT01149785|FG001|Participant Flow|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet twice daily (BID), orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period. A washout period of at least 14 days was maintained between each period.
11019484|NCT01149785|OG000|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
11019485|NCT01149785|OG001|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
11019486|NCT01149785|EG000|Reported Event|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
11019487|NCT01149785|EG001|Reported Event|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
11019488|NCT01149863|BG000|Baseline|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
11019489|NCT01149863|FG000|Participant Flow|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
11019490|NCT01149863|OG000|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
11148596|NCT01865552|BG005|Baseline|US and EU Sourced Enbrel in Part C|"US sourced Enbrel followed by EU sourced Enbrel~EU sourced Enbrel: SC administration~US sourced Enbrel: SC administration"
11019491|NCT01149863|EG000|Reported Event|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
11019492|NCT01149876|BG000|Baseline|Proprietary Topical|
11019493|NCT01149876|BG001|Baseline|Placebo|
11019494|NCT01149876|BG002|Baseline|Tretinoin|
11019495|NCT01149876|BG003|Baseline|Proprietary Topical Plus Iontophoresis|
11019496|NCT01149876|BG004|Baseline|Total|Total of all reporting groups
11019497|NCT01149876|FG000|Participant Flow|Nu Skin Product|
11019498|NCT01149876|FG001|Participant Flow|Over the Counter Moisturizer|CeraVe Moisturizer
11019499|NCT01149876|FG002|Participant Flow|Tretinoin Cream 0.05|
11019500|NCT01149876|FG003|Participant Flow|Nu Skin Product With Galvanic Spa System|
11019501|NCT01149876|OG000|Outcome|Nu Skin Product|
11019502|NCT01149876|OG001|Outcome|Over the Counter Moisturizer|CeraVe cream
11019503|NCT01149876|OG002|Outcome|Tretinoin Cream 0.05|
11019504|NCT01149876|OG003|Outcome|Nu Skin Product With Galvanic Spa System|
11019505|NCT01149876|OG001|Outcome|Over the Counter Moisturizer|
11019506|NCT01149876|EG000|Reported Event|Proprietary Topical|
11019507|NCT01149876|EG001|Reported Event|Placebo|
11019508|NCT01149876|EG002|Reported Event|Tretinoin|
11019509|NCT01149876|EG003|Reported Event|Proprietary Topical Plus Iontophoresis|
11019510|NCT01150097|BG000|Baseline|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
11019511|NCT01150097|BG001|Baseline|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
11019512|NCT01150097|BG002|Baseline|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
11019513|NCT01150097|BG003|Baseline|Total|Total of all reporting groups
11019514|NCT01150097|FG000|Participant Flow|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
11019515|NCT01150097|FG001|Participant Flow|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
11019516|NCT01150097|FG002|Participant Flow|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
11019517|NCT01150097|OG000|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
11019518|NCT01150097|OG001|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
11019519|NCT01150097|OG002|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
11019520|NCT01150097|EG000|Reported Event|Reduced TAC, Month 36|Reduced TAC, Month 36
11019521|NCT01150097|EG001|Reported Event|TAC Elimination, Month 36|TAC Elimination, Month 36
11019522|NCT01150097|EG002|Reported Event|TAC Control, Month 36|TAC Control, Month 36
11019523|NCT01150097|EG003|Reported Event|Reduced RAD + TAC, Month 48|Reduced RAD + TAC, Month 48
11019524|NCT01150097|EG004|Reported Event|TAC Elimination, Month 48|TAC Elimination, Month 48
11019525|NCT01150123|BG000|Baseline|5μg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
11019526|NCT01150123|BG001|Baseline|5μg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
11019527|NCT01150123|BG002|Baseline|20 μg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
11019528|NCT01150123|BG003|Baseline|20 μg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
11019529|NCT01150123|BG004|Baseline|5μg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
11019530|NCT01150123|BG005|Baseline|5μg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
11019531|NCT01150123|BG006|Baseline|20 μg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
11019532|NCT01150123|BG007|Baseline|20 μg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
11019533|NCT01150123|BG008|Baseline|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart t
11019534|NCT01150123|BG009|Baseline|5μg-1 Inj -MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019535|NCT01150123|BG010|Baseline|5μg-2 Inj -MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019536|NCT01150123|BG011|Baseline|20 μg-1 Inj -MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019537|NCT01150123|BG012|Baseline|20 μg-2 Inj -MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019538|NCT01150123|BG013|Baseline|5μg-1 Inj -MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019539|NCT01150123|BG014|Baseline|5μg-2 Inj -MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019540|NCT01150123|BG015|Baseline|20 μg-1 Inj -MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019541|NCT01150123|BG016|Baseline|20 μg-2 Inj-MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019542|NCT01150123|BG017|Baseline|Placebo - Group 2|Subjects received two injections of placebo administered 1 month apart
11019543|NCT01150123|BG018|Baseline|Total|Total of all reporting groups
11148597|NCT01865552|BG006|Baseline|Total|Total of all reporting groups
11019544|NCT01150123|FG000|Participant Flow|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
11019545|NCT01150123|FG001|Participant Flow|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
11019546|NCT01150123|FG002|Participant Flow|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
11019547|NCT01150123|FG003|Participant Flow|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
11019548|NCT01150123|FG004|Participant Flow|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
11019549|NCT01150123|FG005|Participant Flow|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
11019550|NCT01150123|FG006|Participant Flow|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
11019551|NCT01150123|FG007|Participant Flow|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
11019552|NCT01150123|FG008|Participant Flow|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
11019553|NCT01150123|FG009|Participant Flow|5 µg-1 Inj - MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019554|NCT01150123|FG010|Participant Flow|5 µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019555|NCT01150123|FG011|Participant Flow|20 µg-1 Inj - MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019556|NCT01150123|FG012|Participant Flow|20 µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019557|NCT01150123|FG013|Participant Flow|5 µg-1 Inj - MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019558|NCT01150123|FG014|Participant Flow|5 µg-2 Inj - MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019559|NCT01150123|FG015|Participant Flow|20 µg-1 Inj - MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019560|NCT01150123|FG016|Participant Flow|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019561|NCT01150123|FG017|Participant Flow|Placebo - Group 2|Subjects received two injections of placebo administered 1 month apart
11019562|NCT01150123|OG000|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
11019563|NCT01150123|OG001|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
11019564|NCT01150123|OG002|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
11019565|NCT01150123|OG003|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
11019566|NCT01150123|OG004|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
11019567|NCT01150123|OG005|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
11019568|NCT01150123|OG006|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
11019569|NCT01150123|OG007|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
11019570|NCT01150123|OG008|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
11019571|NCT01150123|OG000|Outcome|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
11019572|NCT01150123|OG001|Outcome|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
11019573|NCT01150123|OG004|Outcome|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
11019574|NCT01150123|OG005|Outcome|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
11019575|NCT01150123|OG009|Outcome|5µg-1 Inj - MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019576|NCT01150123|OG010|Outcome|5µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019577|NCT01150123|OG011|Outcome|20 µg-1 Inj - MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019578|NCT01150123|OG012|Outcome|20 µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019579|NCT01150123|OG013|Outcome|5µg-1 Inj - MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019580|NCT01150123|OG014|Outcome|5µg-2 Inj - MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019581|NCT01150123|OG015|Outcome|20 µg-1 Inj - MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019582|NCT01150123|OG016|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019583|NCT01150123|OG017|Outcome|Placebo - Group 2|Subjects received two injections of placebo administered 1 month apart
11019584|NCT01150123|OG009|Outcome|5 µg-1 Inj - MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019585|NCT01150123|OG010|Outcome|5 µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019586|NCT01150123|OG013|Outcome|5 µg-1 Inj - MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019587|NCT01150123|OG014|Outcome|5 µg-2 Inj - MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019588|NCT01150123|OG000|Outcome|5µg-1 Inj - MF59_H|Subjects received single active vaccine injection adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019589|NCT01150123|OG001|Outcome|5µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019590|NCT01150123|OG002|Outcome|20 µg-1 Inj - MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019591|NCT01150123|OG003|Outcome|20 µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019592|NCT01150123|OG004|Outcome|5µg-1 Inj - MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019593|NCT01150123|OG005|Outcome|5µg-2 Inj - MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019594|NCT01150123|OG006|Outcome|20 µg-1 Inj - MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019595|NCT01150123|OG007|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019596|NCT01150123|OG008|Outcome|Placebo - Group 2|Subjects received two injections of placebo administered 1 month apart
11019597|NCT01150123|OG000|Outcome|5µg-1 Inj - MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019598|NCT01150123|OG005|Outcome|5µg-2 Inj - MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019599|NCT01150123|EG000|Reported Event|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
11019600|NCT01150123|EG001|Reported Event|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
11019601|NCT01150123|EG002|Reported Event|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
11019602|NCT01150123|EG003|Reported Event|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
11019603|NCT01150123|EG004|Reported Event|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
11019604|NCT01150123|EG005|Reported Event|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
11019605|NCT01150123|EG006|Reported Event|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
11019606|NCT01150123|EG007|Reported Event|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
11019607|NCT01150123|EG008|Reported Event|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
11019608|NCT01150123|EG009|Reported Event|5µg-1 Inj - MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019609|NCT01150123|EG010|Reported Event|5µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019610|NCT01150123|EG011|Reported Event|20 µg-1 Inj - MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
11019611|NCT01150123|EG012|Reported Event|20 µg-2 Inj - MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
11019612|NCT01150123|EG013|Reported Event|5µg-1 Inj - MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019613|NCT01150123|EG014|Reported Event|5µg-2 Inj - MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019614|NCT01150123|EG015|Reported Event|20 µg-1 Inj - MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
11019615|NCT01150123|EG016|Reported Event|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
11019616|NCT01150123|EG017|Reported Event|Placebo - Group 2|Subjects received two injections of placebo administered 1 month apart
11019617|NCT01150357|BG000|Baseline|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight greater than or equal to (≥) 20 kilogram (kg) to less than (< ) 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and less than or equal to (≤)150 kg received 25 mg of aliskiren.
11019618|NCT01150357|BG001|Baseline|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
11019619|NCT01150357|BG002|Baseline|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
11019620|NCT01150357|BG003|Baseline|Total|Total of all reporting groups
11019621|NCT01150357|FG000|Participant Flow|Aliskiren Low (6.25/12.5/25 mg)|"During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.~During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment."
11019622|NCT01150357|FG001|Participant Flow|Aliskiren Mid (37.5/75/150 mg)|"During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.~During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment."
11019623|NCT01150357|FG002|Participant Flow|Aliskiren High (150/300/600 mg)|"During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.~During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment."
11019624|NCT01150357|OG000|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
11019625|NCT01150357|OG001|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
11019626|NCT01150357|OG002|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
11019627|NCT01150357|OG000|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
11019628|NCT01150357|OG001|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
11019629|NCT01150357|OG002|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
11019630|NCT01150357|OG003|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
11019631|NCT01150357|OG004|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
11019632|NCT01150357|OG005|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
11019633|NCT01150357|EG000|Reported Event|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
11019634|NCT01150357|EG001|Reported Event|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
11019635|NCT01150357|EG002|Reported Event|Phase 1: Aliskiren High (150/300/600 mg)|Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
11019636|NCT01150357|EG003|Reported Event|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
11019637|NCT01150357|EG004|Reported Event|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
11019638|NCT01150357|EG005|Reported Event|Phase 2: Aliskiren High (150/300/600 mg)|"Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and~≤ 150 kg received 600 mg of aliskiren."
11019639|NCT01150357|EG006|Reported Event|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
11019640|NCT01150357|EG007|Reported Event|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily.
11019641|NCT01150357|EG008|Reported Event|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
11019642|NCT01150461|BG000|Baseline|Losartan 50 mg PO BID|
11019643|NCT01150461|BG001|Baseline|Placebo|
11019644|NCT01150461|BG002|Baseline|Total|Total of all reporting groups
11019645|NCT01150461|FG000|Participant Flow|Losartan 50 mg BID|
11019646|NCT01150461|FG001|Participant Flow|Placebo|
11019647|NCT01150461|OG000|Outcome|Losartan 50 mg PO BID|
11019648|NCT01150461|OG001|Outcome|Placebo|
11019649|NCT01150461|EG000|Reported Event|Losartan 50 PO mg BID|
11019650|NCT01150461|EG001|Reported Event|Placebo|
11019651|NCT01150474|BG000|Baseline|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
11019652|NCT01150474|BG001|Baseline|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
11019653|NCT01150474|BG002|Baseline|Total|Total of all reporting groups
11019654|NCT01150474|FG000|Participant Flow|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
11019655|NCT01150474|FG001|Participant Flow|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
11019656|NCT01150474|OG000|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
11019657|NCT01150474|OG001|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
11019658|NCT01150474|EG000|Reported Event|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
11019659|NCT01150474|EG001|Reported Event|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
11019660|NCT01150500|BG000|Baseline|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
11019661|NCT01150500|FG000|Participant Flow|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
11019662|NCT01150500|OG000|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
11019663|NCT01150500|EG000|Reported Event|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
11019664|NCT01150760|BG000|Baseline|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
11019665|NCT01150760|BG001|Baseline|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
11019666|NCT01150760|BG002|Baseline|Total|Total of all reporting groups
11019667|NCT01150760|FG000|Participant Flow|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
11019668|NCT01150760|FG001|Participant Flow|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
11019669|NCT01150760|OG000|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
11019670|NCT01150760|OG001|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
11019671|NCT01150760|EG000|Reported Event|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
11019672|NCT01150760|EG001|Reported Event|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
11019673|NCT01150838|BG000|Baseline|Age 1-6 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued.~propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range"
11019674|NCT01150838|BG001|Baseline|Age 1-6 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued.~propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range"
11019675|NCT01150838|BG002|Baseline|Age 1-6 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued.~propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range"
11148598|NCT01865552|FG000|Participant Flow|SB4 and EU Sourced Enbrel in Part A|"SB4 (Period 1) followed by EU sourced Enbrel (Period 2)~SB4: SC administration~EU sourced Enbrel: SC administration"
11019676|NCT01150838|BG003|Baseline|Age 6-11 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued.~propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range"
11019677|NCT01150838|BG004|Baseline|Age 6-11 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued.~propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range"
11148599|NCT01865552|FG001|Participant Flow|EU Sourced Enbrel and SB4 in Part A|"EU sourced Enbrel (Period 1) followed by SB4 (Period 2)~SB4: SC administration~EU sourced Enbrel: SC administration"
11019678|NCT01150838|BG005|Baseline|Total|Total of all reporting groups
11019679|NCT01150838|FG000|Participant Flow|Age 1-6 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019680|NCT01150838|FG001|Participant Flow|Age 1-6 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019681|NCT01150838|FG002|Participant Flow|Age 1-6 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019682|NCT01150838|FG003|Participant Flow|Age 6-11 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019683|NCT01150838|FG004|Participant Flow|Age 6-11 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019684|NCT01150838|FG005|Participant Flow|Age 6-11 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019685|NCT01150838|OG000|Outcome|Age 1-6 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019686|NCT01150838|OG001|Outcome|Age 1-6 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019687|NCT01150838|OG002|Outcome|Age 1-6 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019688|NCT01150838|OG003|Outcome|Age 6-11 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019689|NCT01150838|OG004|Outcome|Age 6-11 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued until at least 6 crossovers are achieved."
11019690|NCT01150838|EG000|Reported Event|Propofol Administration|"Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is not excellent. Dose will be decreased by 0.3 mg/kg if intubation score is excellent. This dosing scheme will be continued."
11019691|NCT01150903|BG000|Baseline|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
11019692|NCT01150903|BG001|Baseline|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
11019693|NCT01150903|BG002|Baseline|Total|Total of all reporting groups
11148600|NCT01865552|FG002|Participant Flow|SB4 and US Sourced Enbrel in Part B|"SB4 (Period 1) followed by US sourced Enbrel (Period 2)~SB4: SC administration~US sourced Enbrel: SC administration"
11148601|NCT01865552|FG003|Participant Flow|US Sourced Enbrel and SB4 in Part B|"US sourced Enbrel (Period 1) followed by SB4 (Period 2)~SB4: SC administration~US sourced Enbrel: SC administration"
11019694|NCT01150903|FG000|Participant Flow|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
11019695|NCT01150903|FG001|Participant Flow|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
11019696|NCT01150903|OG000|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
11019697|NCT01150903|OG001|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
11019698|NCT01150903|EG000|Reported Event|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
11019699|NCT01150903|EG001|Reported Event|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
11019700|NCT01150981|BG000|Baseline|Rosiglitazone|One 8mg capsule daily for 6 weeks.
11019701|NCT01150981|BG001|Baseline|Placebo|One capsule daily for 6 weeks.
11019702|NCT01150981|BG002|Baseline|Total|Total of all reporting groups
11148602|NCT01865552|FG004|Participant Flow|EU and US Sourced Enbrel in Part C|"EU sourced Enbrel (Period 1) followed by US sourced Enbrel (Period 2)~EU sourced Enbrel: SC administration~US sourced Enbrel: SC administration"
11019703|NCT01150981|FG000|Participant Flow|Rosiglitazone|One 8mg capsule daily for 6 weeks.
11019704|NCT01150981|FG001|Participant Flow|Placebo|One capsule daily for 6 weeks.
11019705|NCT01150981|OG000|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
11019706|NCT01150981|OG001|Outcome|Placebo|One capsule daily for 6 weeks.
11019707|NCT01150981|EG000|Reported Event|Rosiglitazone|One 8mg capsule daily for 6 weeks.
11019708|NCT01150981|EG001|Reported Event|Placebo|One capsule daily for 6 weeks.
11019709|NCT01151020|BG000|Baseline|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
11019710|NCT01151020|FG000|Participant Flow|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
11019711|NCT01151020|OG000|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
11019712|NCT01151020|EG000|Reported Event|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
11019713|NCT01151046|BG000|Baseline|MM-121 + Exemestane|MM-121 and Exemestane: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
11019714|NCT01151046|BG001|Baseline|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
11019715|NCT01151046|BG002|Baseline|Total|Total of all reporting groups
11019716|NCT01151046|FG000|Participant Flow|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
11019717|NCT01151046|FG001|Participant Flow|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
11019718|NCT01151046|OG000|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
11341286|NCT03680105|EG010|Reported Event|Part 2; Cohort 3; RJX or Placebo|Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX every day for 7 days.
11019719|NCT01151046|OG001|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
11019720|NCT01151046|OG000|Outcome|HRG High: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
11019721|NCT01151046|OG001|Outcome|HRG High: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
11019722|NCT01151046|OG002|Outcome|HRG Low: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
11019723|NCT01151046|OG003|Outcome|HRG Low: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
11019724|NCT01151046|EG000|Reported Event|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
11019725|NCT01151046|EG001|Reported Event|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
11019726|NCT01151085|BG000|Baseline|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
11019727|NCT01151085|FG000|Participant Flow|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
11019728|NCT01151085|OG000|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
11019729|NCT01151085|OG000|Outcome|Male|Male Participants taking Voriconazole according to Japanese Package Insert.
11019730|NCT01151085|OG001|Outcome|Female|Female Participants taking Voriconazole according to Japanese Package Insert.
11019731|NCT01151085|OG000|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
11019732|NCT01151085|OG001|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
11019733|NCT01151085|OG002|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
11019734|NCT01151085|OG000|Outcome|With Past History|Participants with Past History who taking Voriconazole according to Japanese Package Insert.
11019735|NCT01151085|OG001|Outcome|Without Past History|Participants without Past History who taking Voriconazole according to Japanese Package Insert.
11019736|NCT01151085|EG000|Reported Event|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
11019737|NCT01151098|BG000|Baseline|Extension Phase (BTDS 5, 10 or 20)|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
11019738|NCT01151098|FG000|Participant Flow|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
11019739|NCT01151098|OG000|Outcome|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10, or 20) applied for 7-day wear.
11019740|NCT01151098|EG000|Reported Event|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
11019741|NCT01151137|BG000|Baseline|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
11019742|NCT01151137|BG001|Baseline|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
11019743|NCT01151137|BG002|Baseline|Total|Total of all reporting groups
11019744|NCT01151137|FG000|Participant Flow|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
11019745|NCT01151137|FG001|Participant Flow|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
11019746|NCT01151137|OG000|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
11019747|NCT01151137|OG001|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
11019748|NCT01151137|EG000|Reported Event|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
11019749|NCT01151137|EG001|Reported Event|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
11019750|NCT01151189|BG000|Baseline|Placebo|Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
11019751|NCT01151189|BG001|Baseline|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.~MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
11019752|NCT01151189|BG002|Baseline|Total|Total of all reporting groups
11019753|NCT01151189|FG000|Participant Flow|Placebo|"The placebo is a licensed product manufactured by Allermed, Inc. and is used for evaluation of delayed-type of hypersensitivity reactions in adults.~Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo."
11019754|NCT01151189|FG001|Participant Flow|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.~MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
11019755|NCT01151189|OG000|Outcome|Placebo|
11019756|NCT01151189|OG001|Outcome|MVA85A/AERAS-485|
11019757|NCT01151189|EG000|Reported Event|Placebo|
11019758|NCT01151189|EG001|Reported Event|MVA85A/AERAS-485|
11019759|NCT01151215|BG000|Baseline|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
11019760|NCT01151215|BG001|Baseline|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
11019761|NCT01151215|BG002|Baseline|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
11019762|NCT01151215|BG003|Baseline|Total|Total of all reporting groups
11019763|NCT01151215|FG000|Participant Flow|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
11019764|NCT01151215|FG001|Participant Flow|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
11019765|NCT01151215|FG002|Participant Flow|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
11019766|NCT01151215|OG000|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
11019767|NCT01151215|OG001|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
11019768|NCT01151215|OG002|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
11019769|NCT01151215|EG000|Reported Event|AZD8931 20mg|
11019770|NCT01151215|EG001|Reported Event|AZD8931 40mg|
11019771|NCT01151215|EG002|Reported Event|Placebo|
11019772|NCT01151280|BG000|Baseline|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
11019773|NCT01151280|FG000|Participant Flow|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
11019774|NCT01151280|OG000|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
11019775|NCT01151280|EG000|Reported Event|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
11019776|NCT01151345|BG000|Baseline|Entire Study Population|Includes groups randomized to receive any treatment (Tilazem 60 mg tablet first or Angiotrofin 60 mg tablet first )
11019777|NCT01151345|FG000|Participant Flow|Tilazem 60 mg Then Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in second intervention period after 7 day clearance period. The total study duration was 9 days.
11019778|NCT01151345|FG001|Participant Flow|Angiotrofin 60 mg Then Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Tilazem®) in second intervention period after 7 day clearance period.The total study duration was 9 days.
11019779|NCT01151345|OG000|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
11019780|NCT01151345|OG001|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
11019781|NCT01151345|EG000|Reported Event|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
11019782|NCT01151345|EG001|Reported Event|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
11019783|NCT01151371|BG000|Baseline|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
11019784|NCT01151371|BG001|Baseline|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
11019785|NCT01151371|BG002|Baseline|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
11019786|NCT01151371|BG003|Baseline|Total|Total of all reporting groups
11019787|NCT01151371|FG000|Participant Flow|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
11019788|NCT01151371|FG001|Participant Flow|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
11019789|NCT01151371|FG002|Participant Flow|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
11019790|NCT01151371|OG000|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
11019791|NCT01151371|OG001|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
11019792|NCT01151371|OG001|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
11019793|NCT01151371|EG000|Reported Event|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
11019794|NCT01151371|EG001|Reported Event|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
11019795|NCT01151371|EG002|Reported Event|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
11019796|NCT01151410|BG000|Baseline|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
11019797|NCT01151410|BG001|Baseline|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
11019798|NCT01151410|BG002|Baseline|Total|Total of all reporting groups
11019799|NCT01151410|FG000|Participant Flow|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
11019800|NCT01151410|FG001|Participant Flow|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
11019801|NCT01151410|OG000|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
11019802|NCT01151410|OG001|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
11019803|NCT01151410|EG000|Reported Event|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
11019804|NCT01151410|EG001|Reported Event|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
11019805|NCT01151423|BG000|Baseline|Caplacizumab|"Caplacizumab:~Subjects received a first i.v. bolus of 10 mg (filled at 5 mg/mL) caplacizumab via push injection within 6 hours to 15 minutes prior to the first PE on study. The first PE on study could either be the very first PE session for the current episode of aTTP (if the subject was randomized prior to the initiation of PE) or the second PE session (if the subject was randomized after a single PE session).~The first PE on study was followed by s.c. administration of 10 mg study drug within 30 minutes after the end of the PE procedure.~All subsequent study drug administrations were daily s.c. injections within 30 minutes after the end of the PE procedure (if applicable) or within 24 hours of the previous dose.~Subjects received caplacizumab up to 30 days after the last PE session."
11019806|NCT01151423|BG001|Baseline|Placebo|"Placebo:~Subjects received a first i.v. bolus of placebo via push injection within 6 hours to 15 minutes prior to the first PE on study. The first PE on study could either be the very first PE session for the current episode of aTTP (if the subject was randomized prior to the initiation of PE) or the second PE session (if the subject was randomized after a single PE session).~The first PE on study was followed by s.c. administration of placebo within 30 minutes after the end of the PE procedure.~All subsequent study drug administrations were daily s.c. injections within 30 minutes after the end of the PE procedure (if applicable) or within 24 hours of the previous dose.~Subjects received placebo up to 30 days after the last PE session."
11019807|NCT01151423|BG002|Baseline|Total|Total of all reporting groups
11019808|NCT01151423|FG000|Participant Flow|Caplacizumab|"Caplacizumab:~Subjects received a first i.v. bolus of 10 mg (filled at 5 mg/mL) caplacizumab via push injection within 6 hours to 15 minutes prior to the first PE on study. The first PE on study could either be the very first PE session for the current episode of aTTP (if the subject was randomized prior to the initiation of PE) or the second PE session (if the subject was randomized after a single PE session).~The first PE on study was followed by s.c. administration of 10 mg study drug within 30 minutes after the end of the PE procedure.~All subsequent study drug administrations were daily s.c. injections within 30 minutes after the end of the PE procedure (if applicable) or within 24 hours of the previous dose.~Subjects received caplacizumab up to 30 days after the last PE session."
11019809|NCT01151423|FG001|Participant Flow|Placebo|"Placebo:~Subjects received a first i.v. bolus of placebo via push injection within 6 hours to 15 minutes prior to the first PE on study. The first PE on study could either be the very first PE session for the current episode of aTTP (if the subject was randomized prior to the initiation of PE) or the second PE session (if the subject was randomized after a single PE session).~The first PE on study was followed by s.c. administration of placebo within 30 minutes after the end of the PE procedure.~All subsequent study drug administrations were daily s.c. injections within 30 minutes after the end of the PE procedure (if applicable) or within 24 hours of the previous dose.~Subjects received placebo up to 30 days after the last PE session."
11019810|NCT01151423|OG000|Outcome|Caplacizumab|Caplacizumab 10 mg once daily
11019811|NCT01151423|OG001|Outcome|Placebo|Placebo once daily
11019812|NCT01151423|EG000|Reported Event|Caplacizumab|Caplacizumab 10 mg once daily
11019813|NCT01151423|EG001|Reported Event|Placebo|Placebo once daily
11019814|NCT01151436|BG000|Baseline|Hyaluronic Acid|
11019815|NCT01151436|FG000|Participant Flow|Hyaluronic Acid|
11019816|NCT01151436|OG000|Outcome|Hyaluronic Acid|
11019817|NCT01151436|EG000|Reported Event|Hyaluronic Acid|
11019818|NCT01151449|BG000|Baseline|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
11019819|NCT01151449|FG000|Participant Flow|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
11019820|NCT01151449|OG000|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
11148603|NCT01865552|FG005|Participant Flow|US and EU Sourced Enbrel in Part C|"US sourced Enbrel (Period 1) followed by EU sourced Enbrel (Period 2)~EU sourced Enbrel: SC administration~US sourced Enbrel: SC administration"
11148604|NCT01865552|OG000|Outcome|SB4 in Part A|SB4: SC administration
11148605|NCT01865552|OG001|Outcome|EU Sourced Enbrel in Part A|EU sourced Enbrel: SC administration
11148606|NCT01865552|OG002|Outcome|SB4 in Part B|SB4: SC administration
11019821|NCT01151449|EG000|Reported Event|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
11148607|NCT01865552|OG003|Outcome|US Sourced Enbrel in Part B|US sourced Enbrel: SC administration
11148608|NCT01865552|OG004|Outcome|EU Sourced Enbrel in Part C|EU sourced Enbrel: SC administration
11148609|NCT01865552|OG005|Outcome|US Sourced Enbrel in Part C|US sourced Enbrel: SC administration
11148610|NCT01865552|EG000|Reported Event|SB4 in Part A|SB4: SC administration
11148611|NCT01865552|EG001|Reported Event|EU Sourced Enbrel in Part A|EU sourced Enbrel: SC administration
11148612|NCT01865552|EG002|Reported Event|SB4 in Part B|SB4: SC administration
11148613|NCT01865552|EG003|Reported Event|US Sourced Enbrel in Part B|US sourced Enbrel: SC administration
11148614|NCT01865552|EG004|Reported Event|EU Sourced Enbrel in Part C|EU sourced Enbrel: SC administration
11148615|NCT01865552|EG005|Reported Event|US Sourced Enbrel in Part C|US sourced Enbrel: SC administration
11019822|NCT01151540|BG000|Baseline|Rufinamide|Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.
11019823|NCT01151540|FG000|Participant Flow|Rufinamide|Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.
11019824|NCT01151540|OG000|Outcome|Rufinamide|Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.
11019825|NCT01151540|EG000|Reported Event|Rufinamide|Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.
11019826|NCT01151579|BG000|Baseline|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
11019827|NCT01151579|BG001|Baseline|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
11019828|NCT01151579|BG002|Baseline|Total|Total of all reporting groups
11019829|NCT01151579|FG000|Participant Flow|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
11019830|NCT01151579|FG001|Participant Flow|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
11019831|NCT01151579|OG000|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
11019832|NCT01151579|OG001|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
11019833|NCT01151579|EG000|Reported Event|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
11019834|NCT01151579|EG001|Reported Event|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
11019835|NCT01151618|BG000|Baseline|Therapy Arm|Non Invasive Ventilation using forced oscillation technique (FOT)
11019836|NCT01151618|FG000|Participant Flow|Therapy Arm|Non Invasive Ventilation using forced oscillation technique (FOT)
11019837|NCT01151618|OG000|Outcome|Therapy Arm|Non Invasive Ventilation using forced oscillation technique (FOT)
11019838|NCT01151618|EG000|Reported Event|Therapy Arm|Non Invasive Ventilation using forced oscillation technique (FOT)
11019839|NCT01151761|BG000|Baseline|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
11019840|NCT01151761|FG000|Participant Flow|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
11019841|NCT01151761|OG000|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
11019842|NCT01151761|EG000|Reported Event|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
11019843|NCT01151813|BG000|Baseline|Within-subjects Design|Varenicline, oral target dose of 1.0 mg BID, one week titration; placebo, matched for one week. Double-blind counterbalanced order
11019844|NCT01151813|FG000|Participant Flow|Varenicline First, Then Placebo|Varenicline, oral target dose of 1.0 mg BID, one week titration; followed by placebo, matched for one week.
11019845|NCT01151813|FG001|Participant Flow|Placebo First, Then Varenicline|Placebo for one week, followed by Varenicline, oral target dose of 1.0 mg BID, one week titration.
11019846|NCT01151813|OG000|Outcome|Varenicline First, Then Placebo|Varenicline, oral target dose of 1.0 mg BID, one week titration; followed by placebo, matched for one week.
11019847|NCT01151813|OG001|Outcome|Placebo First, Then Varenicline|Placebo for one week; followed by Varenicline, oral target dose of 1.0 mg BID, one week titration.
11019848|NCT01151813|OG000|Outcome|Varenicline First, Then Placebo|Varenicline, oral target dose of 1.0 mg BID, one week titration; placebo, matched for one week.
11019849|NCT01151813|EG000|Reported Event|Varenicline|While receiving Varenicline, oral target dose of 1.0 mg BID, one week titration
11019850|NCT01151813|EG001|Reported Event|Placebo|While receiving Placebo, one week
11019851|NCT01151852|BG000|Baseline|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
11019852|NCT01151852|BG001|Baseline|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
11019853|NCT01151852|BG002|Baseline|Total|Total of all reporting groups
11019854|NCT01151852|FG000|Participant Flow|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
11019855|NCT01151852|FG001|Participant Flow|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
11019856|NCT01151852|OG000|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
11019857|NCT01151852|OG001|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
11019858|NCT01151852|EG000|Reported Event|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
11019859|NCT01151852|EG001|Reported Event|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
11019860|NCT01152021|BG000|Baseline|Dexmedetomidine Group|"Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol.~Dexmedetomidine: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete."
11019861|NCT01152021|BG001|Baseline|Propofol Group|"Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to 2 additional 1 mg/kg boluses may be given (total 3 mg/kg) - each over 1 minute, wait 30 seconds after bolus completion to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg.~Propofol: An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete."
11019862|NCT01152021|BG002|Baseline|Total|Total of all reporting groups
11019863|NCT01152021|FG000|Participant Flow|Dexmedetomidine Group|"Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol.~Dexmedetomidine: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete."
11019864|NCT01152021|FG001|Participant Flow|Propofol Group|"Propofol bolus of 1 mg/kg over 1 minute then up to two additional 1 mg/kg boluses may be given (total 3 mg/kg) - each over a one (1) minute interval, waiting 30 seconds after completion of each bolus to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg.~Propofol: An initial bolus of 1mg/kg of propofol will be given over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete."
11019865|NCT01152021|OG000|Outcome|Dexmedetomidine Group|Adverse events in subjects who received dexmedetomidine given bolus and infusion for duration of scan, with or without IV pentobarbital
11019866|NCT01152021|OG001|Outcome|Propofol Group|Adverse events in subjects who received propofol bolus and infusion with or without IV pentobarbital
11019867|NCT01152021|OG000|Outcome|Dexmedetomidine Group|Subjects who received dexmedetomidine
11019868|NCT01152021|OG001|Outcome|Propofol Group|Subjects who received propofol group
11019869|NCT01152021|EG000|Reported Event|Dexmedetomidine Group|"Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol.~Dexmedetomidine: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete."
11019870|NCT01152021|EG001|Reported Event|Propofol Group|"Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to 2 additional 1 mg/kg boluses may be given (total 3 mg/kg) - each over 1 minute interval, wait 30 seconds after bolus completion to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg.~Propofol: An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete."
11019871|NCT01152112|BG000|Baseline|Treatment, Office Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in an office setting~Myomectomy: Removal of fibroids and / or polyps"
11019872|NCT01152112|BG001|Baseline|Treatment, Hospital Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting~Myomectomy: Removal of fibroids and / or polyps"
11019873|NCT01152112|BG002|Baseline|Total|Total of all reporting groups
11019874|NCT01152112|FG000|Participant Flow|Treatment, Office Setting, Myomectomy|Myomectomy for uterine polyps and/or fibroids occurring in an office setting
11019875|NCT01152112|FG001|Participant Flow|Treatment, Hospital Setting, Myomectomy|Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting
11019876|NCT01152112|OG000|Outcome|Treatment, Office Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in an office setting~Myomectomy: Removal of fibroids and / or polyps"
11019877|NCT01152112|OG001|Outcome|Treatment, Hospital Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting~Myomectomy: Removal of fibroids and / or polyps"
11019878|NCT01152112|EG000|Reported Event|Treatment, Office Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in an office setting~Myomectomy: Removal of fibroids and / or polyps"
11019879|NCT01152112|EG001|Reported Event|Treatment, Hospital Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting~Myomectomy: Removal of fibroids and / or polyps"
11019880|NCT01152190|BG000|Baseline|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
11019881|NCT01152190|BG001|Baseline|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
11019882|NCT01152190|BG002|Baseline|Total|Total of all reporting groups
11019883|NCT01152190|FG000|Participant Flow|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
11019884|NCT01152190|FG001|Participant Flow|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
11019885|NCT01152190|OG000|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
11019886|NCT01152190|OG001|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
11019887|NCT01152190|EG000|Reported Event|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
11019888|NCT01152190|EG001|Reported Event|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
11019889|NCT01152294|BG000|Baseline|Control|Group not receiving the decision aid (DVD and booklet)
11019890|NCT01152294|BG001|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
11019891|NCT01152294|BG002|Baseline|Total|Total of all reporting groups
11019892|NCT01152294|FG000|Participant Flow|Control|Group not receiving the decision aid (DVD and booklet)
11019893|NCT01152294|FG001|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
11019894|NCT01152294|OG000|Outcome|Control|Group not receiving the decision aid (DVD and booklet)
11019895|NCT01152294|OG001|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
11019896|NCT01152294|EG000|Reported Event|Control|Group not receiving the decision aid (DVD and booklet)
11019897|NCT01152294|EG001|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
11019898|NCT01152307|BG000|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
11019899|NCT01152307|BG001|Baseline|Control|Group not receiving the decision aid (DVD/booklet)
11019900|NCT01152307|BG002|Baseline|Total|Total of all reporting groups
11019901|NCT01152307|FG000|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
11019902|NCT01152307|FG001|Participant Flow|Control|Group not receiving the decision aid (DVD/booklet)
11019903|NCT01152307|OG000|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
11019904|NCT01152307|OG001|Outcome|Control|Group not receiving the decision aid (DVD/booklet)
11019905|NCT01152307|EG000|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
11019906|NCT01152307|EG001|Reported Event|Control|Group not receiving the decision aid (DVD/booklet)
11019907|NCT01152359|BG000|Baseline|Choice Arm|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
11019908|NCT01152359|BG001|Baseline|Control Arm|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
11019909|NCT01152359|BG002|Baseline|Total|Total of all reporting groups
11148616|NCT01865708|BG000|Baseline|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
11019910|NCT01152359|FG000|Participant Flow|Choice Arm|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
11019911|NCT01152359|FG001|Participant Flow|Control Arm|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
11019912|NCT01152359|OG000|Outcome|Choice Arm|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
11019913|NCT01152359|OG001|Outcome|Control Arm|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
11019914|NCT01152359|EG000|Reported Event|Choice Arm|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
11019915|NCT01152359|EG001|Reported Event|Control Arm|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
11019916|NCT01152385|BG000|Baseline|High Dose|200 mg (daily dose)
11019917|NCT01152385|BG001|Baseline|Middle Dose|140 mg (daily dose)
11019918|NCT01152385|BG002|Baseline|Low Dose|80 mg (daily dose)
11019919|NCT01152385|BG003|Baseline|Placebo|Placebo
11019920|NCT01152385|BG004|Baseline|Total|Total of all reporting groups
11019921|NCT01152385|FG000|Participant Flow|High Dose|200 mg (daily dose)
11019922|NCT01152385|FG001|Participant Flow|Middle Dose|140 mg (daily dose)
11019923|NCT01152385|FG002|Participant Flow|Low Dose|80 mg (daily dose)
11019924|NCT01152385|FG003|Participant Flow|Placebo|Placebo
11019925|NCT01152385|OG000|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
11019926|NCT01152385|OG001|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
11019927|NCT01152385|OG002|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
11019928|NCT01152385|OG003|Outcome|Arm 4 - Placebo Dose|Placebo
11019929|NCT01152385|OG000|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
11019930|NCT01152385|OG001|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
11019931|NCT01152385|OG002|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
11019932|NCT01152385|OG003|Outcome|Arm 4 - Placebo|Placebo
11019933|NCT01152385|EG000|Reported Event|High Dose|200 mg (daily dose)
11019934|NCT01152385|EG001|Reported Event|Middle Dose|140 mg (daily dose)
11019935|NCT01152385|EG002|Reported Event|Low Dose|80 mg (daily dose)
11019936|NCT01152385|EG003|Reported Event|Placebo|Placebo
11019937|NCT01152437|BG000|Baseline|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019938|NCT01152437|BG001|Baseline|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
11019939|NCT01152437|BG002|Baseline|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019940|NCT01152437|BG003|Baseline|Total|Total of all reporting groups
11019941|NCT01152437|FG000|Participant Flow|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019942|NCT01152437|FG001|Participant Flow|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
11019943|NCT01152437|FG002|Participant Flow|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019944|NCT01152437|OG000|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019945|NCT01152437|OG001|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
11019946|NCT01152437|OG000|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019947|NCT01152437|OG002|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019948|NCT01152437|OG001|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019949|NCT01152437|EG000|Reported Event|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019950|NCT01152437|EG001|Reported Event|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
11019951|NCT01152437|EG002|Reported Event|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
11019952|NCT01152450|BG000|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
11019953|NCT01152450|FG000|Participant Flow|Tio R2.5 Twice Daily (Bid) /Tio R5 Once Daily (qd) /Placebo|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with a matching Placebo in period 3 (morning and evening). All products were delivered by the Respimat inhaler, on top on maintenance therapy with inhaled corticosteroid (iCS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11019954|NCT01152450|FG001|Participant Flow|Tio R2.5 Bid/Placebo/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching Placebo in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11019955|NCT01152450|FG002|Participant Flow|Tio R5 qd/Tio R2.5 Bid/Placebo|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with Tiotropium 2.5 mcg in period 2 (morning and evening) and with matching Placebo in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11019956|NCT01152450|FG003|Participant Flow|Tio R5 qd/Placebo/Tio R2.5 Bid|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with matching Placebo in period 2 (morning and evening) and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11019957|NCT01152450|FG004|Participant Flow|Placebo/Tio R2.5 Bid/Tio R5 qd|Patients treated with matching Placebo in period 1 (morning and evening), with Tiotropium 2.5 mcg in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11019958|NCT01152450|FG005|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 Bid|Patients treated with a matching Placebo in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11019959|NCT01152450|OG000|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
11019960|NCT01152450|OG001|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
11019961|NCT01152450|OG002|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
11019962|NCT01152450|EG000|Reported Event|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
11019963|NCT01152450|EG001|Reported Event|Tio R2.5|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
11019964|NCT01152450|EG002|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
11019965|NCT01152515|BG000|Baseline|Control|stopping of propofol and remifentanil infusion
11019966|NCT01152515|BG001|Baseline|Remifentanil|stopping of propofol and maintenance of remifentanil infusion
11019967|NCT01152515|BG002|Baseline|Total|Total of all reporting groups
11019968|NCT01152515|FG000|Participant Flow|Control|stopping of propofol and remifentanil infusion
11019969|NCT01152515|FG001|Participant Flow|Remifentanil|stopping of propofol and maintenance of remifentanil infusion
11019970|NCT01152515|OG000|Outcome|Control|stopping of propofol and remifentanil infusion
11019971|NCT01152515|OG001|Outcome|Remifentanil|stopping of propofol and maintenance of remifentanil infusion
11019972|NCT01152515|EG000|Reported Event|Control|stopping of propofol and remifentanil infusion
11019973|NCT01152515|EG001|Reported Event|Remifentanil|stopping of propofol and maintenance of remifentanil infusion
11019974|NCT01152554|BG000|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11019975|NCT01152554|BG001|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11019976|NCT01152554|BG002|Baseline|Total|Total of all reporting groups
11019977|NCT01152554|FG000|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11019978|NCT01152554|FG001|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11019979|NCT01152554|OG000|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11019980|NCT01152554|OG001|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11019981|NCT01152554|EG000|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
11019982|NCT01152554|EG001|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11019983|NCT01152580|BG000|Baseline|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
11019984|NCT01152580|BG001|Baseline|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
11019985|NCT01152580|BG002|Baseline|Total|Total of all reporting groups
11019986|NCT01152580|FG000|Participant Flow|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
11019987|NCT01152580|FG001|Participant Flow|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
11019988|NCT01152580|OG000|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
11019989|NCT01152580|OG001|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
11019990|NCT01152580|EG000|Reported Event|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
11019991|NCT01152580|EG001|Reported Event|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
11019992|NCT01152697|BG000|Baseline|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
11019993|NCT01152697|FG000|Participant Flow|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). Dosage form was a long acting injectable administered every three to five weeks. Mean endpoint dose was 68.0 mg.
11019994|NCT01152697|OG000|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
11019995|NCT01152697|EG000|Reported Event|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
11019996|NCT01152788|BG000|Baseline|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
11019997|NCT01152788|BG001|Baseline|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
11019998|NCT01152788|BG002|Baseline|Total|Total of all reporting groups
11019999|NCT01152788|FG000|Participant Flow|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
11020000|NCT01152788|FG001|Participant Flow|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
11020001|NCT01152788|OG000|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
11020002|NCT01152788|OG001|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
11020003|NCT01152788|EG000|Reported Event|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
11020004|NCT01152788|EG001|Reported Event|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
11020005|NCT01152814|BG000|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
11020006|NCT01152814|FG000|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
11020007|NCT01152814|OG000|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
11020008|NCT01152814|EG000|Reported Event|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
11020009|NCT01152996|BG000|Baseline|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
11020010|NCT01152996|FG000|Participant Flow|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
11020011|NCT01152996|OG000|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
11020012|NCT01152996|EG000|Reported Event|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
11020013|NCT01153009|BG000|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
11020014|NCT01153009|BG001|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
11020015|NCT01153009|BG002|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
11020016|NCT01153009|BG003|Baseline|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
11020017|NCT01153009|BG004|Baseline|Total|Total of all reporting groups
11020018|NCT01153009|FG000|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
11020019|NCT01153009|FG001|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
11020020|NCT01153009|FG002|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
11020021|NCT01153009|FG003|Participant Flow|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
11020022|NCT01153009|OG000|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
11020023|NCT01153009|OG001|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
11020024|NCT01153009|OG002|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
11020025|NCT01153009|OG003|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
11020026|NCT01153009|EG000|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
11020027|NCT01153009|EG001|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
11020028|NCT01153009|EG002|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
11020029|NCT01153009|EG003|Reported Event|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
11020030|NCT01153269|BG000|Baseline|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
11020031|NCT01153269|FG000|Participant Flow|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
11020032|NCT01153269|OG000|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
11020033|NCT01153269|OG001|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
11020034|NCT01153269|OG000|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
11020035|NCT01153269|OG000|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
11020036|NCT01153269|EG000|Reported Event|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
11020037|NCT01153321|BG000|Baseline|AZD2423|Two 50 mg AZD2423 tablets, once daily
11020038|NCT01153321|BG001|Baseline|Placebo|Placebo to match AZD2423 tablets, once daily
11020039|NCT01153321|BG002|Baseline|Total|Total of all reporting groups
11020040|NCT01153321|FG000|Participant Flow|AZD2423|Two 50 mg AZD2423 tablets, once daily
11020041|NCT01153321|FG001|Participant Flow|Placebo|Placebo to match AZD2423 tablets, once daily
11020042|NCT01153321|OG000|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
11020043|NCT01153321|OG001|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
11020044|NCT01153321|EG000|Reported Event|AZD2423 100 mg|
11020045|NCT01153321|EG001|Reported Event|Placebo|Placebo to match AZD2423 tablets, once daily
11066196|NCT01390948|EG001|Reported Event|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
11066197|NCT01390948|EG002|Reported Event|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
11066198|NCT01391000|BG000|Baseline|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
11020046|NCT01153347|BG000|Baseline|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
11020047|NCT01153347|BG001|Baseline|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
11020048|NCT01153347|BG002|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
11020049|NCT01153347|BG003|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11020050|NCT01153347|BG004|Baseline|Total|Total of all reporting groups
11020051|NCT01153347|FG000|Participant Flow|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
11020052|NCT01153347|FG001|Participant Flow|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
11020053|NCT01153347|FG002|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
11020054|NCT01153347|FG003|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11020055|NCT01153347|OG000|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
11020056|NCT01153347|OG001|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
11020057|NCT01153347|OG002|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
11020058|NCT01153347|OG003|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11020059|NCT01153347|EG000|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
11020060|NCT01153347|EG001|Reported Event|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
11020061|NCT01153347|EG002|Reported Event|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
11020062|NCT01153347|EG003|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
11020063|NCT01153425|BG000|Baseline|Teriparatide (Forteo)|"20 µg of Teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.~Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
11020064|NCT01153425|BG001|Baseline|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.~Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
11020065|NCT01153425|BG002|Baseline|Total|Total of all reporting groups
11020066|NCT01153425|FG000|Participant Flow|Teriparatide (Forteo)|"20 µg of Teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.~Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
11020067|NCT01153425|FG001|Participant Flow|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.~Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
11341287|NCT03680521|BG000|Baseline|Sitravatinib 120 mg|Participants received sitravatinib orally, once a day, at a dose of 120 mg for 2 weeks (segment 1). Then, the participants continued to receive sitravatinib in combination with nivolumab 240 mg administered as an intravenous (IV) infusion every 2 weeks, for a maximum of 6 additional weeks (segment 2).
11020068|NCT01153425|OG000|Outcome|Teriparatide (Forteo)|"20 µg of Teriparatide self-injected subcutaneously once a day for 24 months with MRI performed at 0, 12 and 24 months.~The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone's platelikeness, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.~No difference was detected between the two treatment arms."
11020069|NCT01153425|OG001|Outcome|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid administered intravenously at baseline and 12 months and MRI performed at 0, 12, and 24 months.~The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone's platelikeness, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.~No difference was detected between the two treatment arms."
11020070|NCT01153425|OG000|Outcome|Teriparatide (Forteo)|"20 µg of Teriparatide self-injected subcutaneously once a day for 24 months with MRI performed at 0 and 24 months.~The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone's platelikeness, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.~No difference was detected between the two treatment arms."
11020071|NCT01153425|EG000|Reported Event|Teriparatide (Forteo)|"20 µg of teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.~Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.~Teriparatide: Participants are clinically indicated for treatment."
11020072|NCT01153425|EG001|Reported Event|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.~Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.~Zoledronic Acid: Participants are clinically indicated for treatment."
11020073|NCT01153503|BG000|Baseline|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
11020074|NCT01153503|BG001|Baseline|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
11020075|NCT01153503|BG002|Baseline|Ketorolac 30 mg IV|"Ketorolac 30 mg, IV at the end of surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
11020076|NCT01153503|BG003|Baseline|Total|Total of all reporting groups
11020077|NCT01153503|FG000|Participant Flow|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP blocks and Ketorolac 30 mg IV at the end of the surgery~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h and IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
11020078|NCT01153503|FG001|Participant Flow|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h Postoperative: IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
11020079|NCT01153503|FG002|Participant Flow|Ketorolac 30 mg|"Ketorolac 30 mg, IV at the end of surgery~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
11020080|NCT01153503|OG000|Outcome|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
11020081|NCT01153503|OG001|Outcome|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
11020082|NCT01153503|OG002|Outcome|Ketorolac 30 mg|"Ketorolac 30 mg after surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
11020083|NCT01153503|EG000|Reported Event|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
11020084|NCT01153503|EG001|Reported Event|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
11020085|NCT01153503|EG002|Reported Event|Ketorolac 30 mg|"Ketorolac 30 mg after surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
11020086|NCT01153516|BG000|Baseline|Diet Only Group|Patients on diet and activity protocol typical for patients after bariatric surgery
11020087|NCT01153516|BG001|Baseline|Surgery and Diet Group|Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
11020088|NCT01153516|BG002|Baseline|Total|Total of all reporting groups
11020089|NCT01153516|FG000|Participant Flow|Diet Only Group|Patients on diet and activity protocol typical for patients after bariatric surgery
11020090|NCT01153516|FG001|Participant Flow|Surgery and Diet Group|Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
11020091|NCT01153516|OG000|Outcome|Diet Only Group|Patients on diet and activity protocol typical for patients after bariatric surgery
11020092|NCT01153516|OG001|Outcome|Surgery and Diet Group|Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
11020093|NCT01153516|EG000|Reported Event|Diet Only Group|Patients on diet and activity protocol typical for patients after bariatric surgery
11020094|NCT01153516|EG001|Reported Event|Surgery and Diet Group|Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
11020095|NCT01153581|BG000|Baseline|Women|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
11020096|NCT01153581|FG000|Participant Flow|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
11020097|NCT01153581|OG000|Outcome|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
11020098|NCT01153581|OG000|Outcome|Low Orthostatic Tolerance|Women who pass out easily in response to posture change
11020099|NCT01153581|OG001|Outcome|High Orthostatic Tolerant|Women who can tolerate posture changes
11020100|NCT01153581|OG000|Outcome|Women With Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
11020101|NCT01153581|OG001|Outcome|Women Without Orthostatic Tolerance|Women who pass out easily with gravitational challenge
11020102|NCT01153581|EG000|Reported Event|Ganirelix Acetate|Ganirelix acetate (Organon, Roseland, NJ, USA), a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotrophin-releasing hormone (GnRH) to suppress GnRH. (250 μg in 0.5ml normal saline for 16 days).
11020103|NCT01153581|EG001|Reported Event|17β-Oestradiol|The same women added 17β-Oestradiol, E2; 0.2 mg day-1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.
11020104|NCT01153581|EG002|Reported Event|Progesterone|The same women added progesterone (P4, 200 mg day-1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13-16.
11020105|NCT01153620|BG000|Baseline|Ringer's Solution|
11020106|NCT01153620|BG001|Baseline|Lavasept 0.04%|
11020107|NCT01153620|BG002|Baseline|Total|Total of all reporting groups
11341288|NCT03680521|BG001|Baseline|Sitravatinib 80 mg|Participants received sitravatinib orally, once a day, at a dose of 80 mg for 2 weeks (segment 1). Then, the participants continued to receive sitravatinib in combination with nivolumab 240 mg administered as an intravenous (IV) infusion every 2 weeks, for a maximum of 6 additional weeks (segment 2).
11020108|NCT01153620|FG000|Participant Flow|Ringer's Solution|
11020109|NCT01153620|FG001|Participant Flow|Lavasept 0.04%|
11020110|NCT01153620|OG000|Outcome|Lavasept 0.04%|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
11020111|NCT01153620|OG001|Outcome|Ringer's Solution|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
11020112|NCT01153620|EG000|Reported Event|Ringer's Solution|
11020113|NCT01153620|EG001|Reported Event|Lavasept 0.04%|
11020114|NCT01153633|BG000|Baseline|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
11020115|NCT01153633|BG001|Baseline|Normal Saline and Placebo Gel|Sodium Choride 0.9% Solution, Neutral Gel without Polihexanide, without Betaine
11020116|NCT01153633|BG002|Baseline|Total|Total of all reporting groups
11020117|NCT01153633|FG000|Participant Flow|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
11020118|NCT01153633|FG001|Participant Flow|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
11020119|NCT01153633|OG000|Outcome|Prontosan Wound Irrigation Solution and Gel|Polihexanide 0.1%, Betaine 01.%, purified water, exipients
11020120|NCT01153633|OG001|Outcome|Normal Saline and Inactive Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
11020121|NCT01153633|OG000|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
11020122|NCT01153633|OG001|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
11020123|NCT01153633|EG000|Reported Event|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
11020124|NCT01153633|EG001|Reported Event|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
11020125|NCT01153672|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
11020126|NCT01153672|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
11341289|NCT03680521|BG002|Baseline|Total|Total of all reporting groups
11020127|NCT01153672|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
11020128|NCT01153672|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
11020129|NCT01153685|BG000|Baseline|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
11020130|NCT01153685|BG001|Baseline|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
11020131|NCT01153685|BG002|Baseline|Total|Total of all reporting groups
11020132|NCT01153685|FG000|Participant Flow|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
11020133|NCT01153685|FG001|Participant Flow|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
11020134|NCT01153685|OG000|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
11020135|NCT01153685|OG001|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
11020136|NCT01153685|EG000|Reported Event|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
11020137|NCT01153685|EG001|Reported Event|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
11020138|NCT01153698|BG000|Baseline|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
11225673|NCT02370004|BG000|Baseline|Resistive Flexibility and Strength Training|"Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner.~Resistive Flexibility and Strength Training: RFST is a physical therapy technique where a certified practitioner extends or flexes a joint with the subject actively resists the motion applied by the practitioner.~During the RFST treatment a subject will lie on a massage table while the practitioner holds the subject's arm or leg and flexes or extends the limb, instructing the patient to resist the flexion or extension produced by the practitioner. The process is repeated a number of times for each muscle while varying joint positions."
11020139|NCT01153698|FG000|Participant Flow|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
11020140|NCT01153698|OG000|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
11020141|NCT01153698|EG000|Reported Event|Enoxaparin 40mg|All patients treated with enoxaparin
10886228|NCT00492856|FG001|Participant Flow|Post-consolidation ATRA, 6-MP, MTX|Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
11020142|NCT01153698|EG001|Reported Event|Pradaxa 220mg|All patients treated with Pradaxa
11020143|NCT01153711|BG000|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
11020144|NCT01153711|FG000|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
11020145|NCT01153711|OG000|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
11020146|NCT01153711|OG001|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
11020147|NCT01153711|EG000|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
11225674|NCT02370004|FG000|Participant Flow|Resistive Flexibility and Strength Training|"Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner.~Resistive Flexibility and Strength Training: RFST is a physical therapy technique where a certified practitioner extends or flexes a joint with the subject actively resists the motion applied by the practitioner.~During the RFST treatment a subject will lie on a massage table while the practitioner holds the subject's arm or leg and flexes or extends the limb, instructing the patient to resist the flexion or extension produced by the practitioner. The process is repeated a number of times for each muscle while varying joint positions."
11020148|NCT01153711|EG001|Reported Event|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
11020149|NCT01153724|BG000|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
11020150|NCT01153724|FG000|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
11020151|NCT01153724|OG000|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
11020152|NCT01153724|OG001|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
11020153|NCT01153724|EG000|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
11020154|NCT01153724|EG001|Reported Event|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
11020155|NCT01153763|BG000|Baseline|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
11020156|NCT01153763|FG000|Participant Flow|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
11020157|NCT01153763|OG000|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
11020158|NCT01153763|EG000|Reported Event|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
11020159|NCT01153815|BG000|Baseline|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11020160|NCT01153815|BG001|Baseline|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11020161|NCT01153815|BG002|Baseline|Total|Total of all reporting groups
11020162|NCT01153815|FG000|Participant Flow|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11020163|NCT01153815|FG001|Participant Flow|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11020164|NCT01153815|OG000|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11020165|NCT01153815|OG001|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11020166|NCT01153815|EG000|Reported Event|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11020167|NCT01153815|EG001|Reported Event|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11020168|NCT01153841|BG000|Baseline|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
11020169|NCT01153841|BG001|Baseline|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
11020170|NCT01153841|BG002|Baseline|Total|Total of all reporting groups
10886229|NCT00492856|FG002|Participant Flow|Post-consolidation Observation|Patients who achieved CRm after consolidation and were randomized to the observation arm.
11020171|NCT01153841|FG000|Participant Flow|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
11020172|NCT01153841|FG001|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
11020173|NCT01153841|OG000|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
11020174|NCT01153841|OG001|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
11020175|NCT01153841|EG000|Reported Event|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
11020176|NCT01153841|EG001|Reported Event|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
11020177|NCT01153893|BG000|Baseline|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
11020178|NCT01153893|BG001|Baseline|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
11020179|NCT01153893|BG002|Baseline|Total|Total of all reporting groups
11020180|NCT01153893|FG000|Participant Flow|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
11020181|NCT01153893|FG001|Participant Flow|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
11020182|NCT01153893|OG000|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
11020183|NCT01153893|OG001|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
11020184|NCT01153893|EG000|Reported Event|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
11020185|NCT01153893|EG001|Reported Event|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
11020186|NCT01153958|BG000|Baseline|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
11020187|NCT01153958|BG001|Baseline|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
11020188|NCT01153958|BG002|Baseline|Total|Total of all reporting groups
11020189|NCT01153958|FG000|Participant Flow|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
11020190|NCT01153958|FG001|Participant Flow|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
11020191|NCT01153958|OG000|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
11020192|NCT01153958|OG001|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
11020193|NCT01153958|EG000|Reported Event|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
11020194|NCT01153958|EG001|Reported Event|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
11020195|NCT01153971|BG000|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
11020196|NCT01153971|FG000|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with complete response (CR), unconfirmed complete response (CRu), or partial response (PR), received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
11020197|NCT01153971|OG000|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
11020198|NCT01153971|EG000|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
11020199|NCT01153984|BG000|Baseline|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
11020200|NCT01153984|FG000|Participant Flow|Erlotinib|Participants received 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
11020201|NCT01153984|OG000|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
11225675|NCT02370004|OG000|Outcome|Resistive Flexibility and Strength Training|"Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner.~Resistive Flexibility and Strength Training: RFST is a physical therapy technique where a certified practitioner extends or flexes a joint with the subject actively resists the motion applied by the practitioner.~During the RFST treatment a subject will lie on a massage table while the practitioner holds the subject's arm or leg and flexes or extends the limb, instructing the patient to resist the flexion or extension produced by the practitioner. The process is repeated a number of times for each muscle while varying joint positions."
11225676|NCT02370004|OG000|Outcome|Asthma Control Test|Asthma Control Test which is a measure of asthma control and symptoms over the last four weeks
11020202|NCT01153984|EG000|Reported Event|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
11020203|NCT01154010|BG000|Baseline|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids."
11225677|NCT02370004|OG000|Outcome|Range of Motion- Pre Intervention- Circumference|Range of Motion and mobility- pre intervention
11225678|NCT02370004|OG001|Outcome|Range of Motion- Post Intervention- Circumference|Range of Motion - Post intervention
11225679|NCT02370004|OG000|Outcome|Range of Motion- Pre Intervention- Degree|Range of Motion and mobility- pre intervention
11225680|NCT02370004|OG001|Outcome|Range of Motion- Post Intervention- Degree|Range of Motion - Post intervention
11341290|NCT03680521|FG000|Participant Flow|Sitravatinib 120 mg|Participants received sitravatinib orally, once a day, at a dose of 120 mg for 2 weeks (segment 1). Then, the participants continued to receive sitravatinib in combination with nivolumab 240 mg administered as an intravenous (IV) infusion every 2 weeks, for a maximum of 6 additional weeks (segment 2).
11020204|NCT01154010|BG001|Baseline|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids."
11020205|NCT01154010|BG002|Baseline|Total|Total of all reporting groups
11020206|NCT01154010|FG000|Participant Flow|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
11020207|NCT01154010|FG001|Participant Flow|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
11020208|NCT01154010|OG000|Outcome|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
11020209|NCT01154010|OG001|Outcome|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
11020210|NCT01154010|EG000|Reported Event|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis on-going as of December, 2016."
11020211|NCT01154010|EG001|Reported Event|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis on-going as of December, 2016."
11020212|NCT01154088|BG000|Baseline|Nimenrix-A Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
11020213|NCT01154088|BG001|Baseline|Nimenrix-B Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
11020214|NCT01154088|BG002|Baseline|Mencevax Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
11020215|NCT01154088|BG003|Baseline|Total|Total of all reporting groups
10886230|NCT00492856|FG003|Participant Flow|Post-consolidation Gemtuzumab Ozogamicin|Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does).
11020216|NCT01154088|FG000|Participant Flow|Nimenrix-A Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
11020217|NCT01154088|FG001|Participant Flow|Nimenrix-B Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
11020218|NCT01154088|FG002|Participant Flow|Mencevax Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
11020219|NCT01154088|OG000|Outcome|Nimenrix-A Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
11020220|NCT01154088|OG001|Outcome|Nimenrix-B Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
11020221|NCT01154088|OG002|Outcome|Mencevax Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
11020222|NCT01154088|OG001|Outcome|Mencevax Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
11020223|NCT01154088|EG000|Reported Event|Nimenrix-A Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
11020224|NCT01154088|EG001|Reported Event|Nimenrix-B Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
11020225|NCT01154088|EG002|Reported Event|Mencevax Group|Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
11020226|NCT01154101|BG000|Baseline|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020227|NCT01154101|BG001|Baseline|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 gram (g) capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020228|NCT01154101|BG002|Baseline|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020229|NCT01154101|BG003|Baseline|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020230|NCT01154101|BG004|Baseline|No Treatment|Eligible participants in this arm received no treatment. No treatment arm was used when participants were randomized but discontinued prior to dosing.
11020231|NCT01154101|BG005|Baseline|Total|Total of all reporting groups
11020232|NCT01154101|FG000|Participant Flow|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020233|NCT01154101|FG001|Participant Flow|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 gram (g) capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020234|NCT01154101|FG002|Participant Flow|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020235|NCT01154101|FG003|Participant Flow|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020236|NCT01154101|FG004|Participant Flow|No Treatment|Eligible participants in this arm received no treatment. No treatment arm was used when participants were randomized but discontinued prior to dosing.
11148617|NCT01865708|FG000|Participant Flow|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
11020237|NCT01154101|OG000|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020238|NCT01154101|OG001|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020239|NCT01154101|OG002|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020240|NCT01154101|OG003|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020241|NCT01154101|OG000|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020242|NCT01154101|OG001|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020243|NCT01154101|OG002|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020244|NCT01154101|OG000|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
11020245|NCT01154101|OG001|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
11020246|NCT01154101|OG002|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
11020247|NCT01154101|OG003|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
11020248|NCT01154101|EG000|Reported Event|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020249|NCT01154101|EG001|Reported Event|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020250|NCT01154101|EG002|Reported Event|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020251|NCT01154101|EG003|Reported Event|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
11020252|NCT01154127|BG000|Baseline|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
11020253|NCT01154127|BG001|Baseline|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days~Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
11020254|NCT01154127|BG002|Baseline|Total|Total of all reporting groups
11020255|NCT01154127|FG000|Participant Flow|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
11020256|NCT01154127|FG001|Participant Flow|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days~Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
11020257|NCT01154127|OG000|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
11020258|NCT01154127|OG001|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
11020259|NCT01154127|EG000|Reported Event|NVA237|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
11020260|NCT01154127|EG001|Reported Event|Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
11020261|NCT01154140|BG000|Baseline|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
11020262|NCT01154140|BG001|Baseline|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
11020263|NCT01154140|BG002|Baseline|Total|Total of all reporting groups
11020264|NCT01154140|FG000|Participant Flow|Crizotinib|Crizotinib 250 mg (milligram) capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of (Response Evaluation Criteria in Solid Tumors) RECIST v1.1 defined PD, as determined by Independent Radiology Review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
10886231|NCT00492856|OG000|Outcome|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
10886232|NCT00492856|OG001|Outcome|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
11020265|NCT01154140|FG001|Participant Flow|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 intravenous (IV) infusion according to standard of care was administered over 10 minutes (min); either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an area under the concentration time curve (AUC) of 5 or 6 milligram*minute per millilitre (mg*min/mL), approximately 30 min after end of pemetrexed infusion.
11020266|NCT01154140|OG000|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
11020267|NCT01154140|OG001|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
11020268|NCT01154140|EG000|Reported Event|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
11020269|NCT01154140|EG001|Reported Event|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
11020270|NCT01154153|BG000|Baseline|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
11020271|NCT01154153|BG001|Baseline|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
11020272|NCT01154153|BG002|Baseline|Total|Total of all reporting groups
11020273|NCT01154153|FG000|Participant Flow|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
11020274|NCT01154153|FG001|Participant Flow|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
11020275|NCT01154153|OG000|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
11020276|NCT01154153|OG001|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
11020277|NCT01154153|EG000|Reported Event|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
11020278|NCT01154153|EG001|Reported Event|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
11020279|NCT01154166|BG000|Baseline|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
11020280|NCT01154166|BG001|Baseline|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
11020281|NCT01154166|BG002|Baseline|Total|Total of all reporting groups
11020282|NCT01154166|FG000|Participant Flow|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
11020283|NCT01154166|FG001|Participant Flow|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
11020284|NCT01154166|OG000|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
11020285|NCT01154166|OG001|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
11020286|NCT01154166|EG000|Reported Event|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
11020287|NCT01154166|EG001|Reported Event|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
11020288|NCT01154192|BG000|Baseline|PCOS Group|Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
11020289|NCT01154192|BG001|Baseline|Normal Group|Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.
11020290|NCT01154192|BG002|Baseline|Oligomenorrhea Group|
11020291|NCT01154192|BG003|Baseline|Total|Total of all reporting groups
11020292|NCT01154192|FG000|Participant Flow|PCOS Group|"Intervention: Each subject in the PCOS group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.~Dexamethasone: Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.~recombinant human chorionic gonadotropin (r-hCG): Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection"
11020293|NCT01154192|FG001|Participant Flow|Normal Group|"Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.~Dexamethasone"
11020294|NCT01154192|FG002|Participant Flow|There Were Only 2 Groups: PCOS and Normal Subjects|
11020295|NCT01154192|OG000|Outcome|PCOS Group|Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
11020296|NCT01154192|OG001|Outcome|Normal Group|Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.
11020297|NCT01154192|OG002|Outcome|Oligomenorrhea Group|
11020298|NCT01154192|OG001|Outcome|Normal Group|"Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.~."
11020299|NCT01154192|EG000|Reported Event|PCOS Group|Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
11020300|NCT01154192|EG001|Reported Event|Normal Group|Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.
11020301|NCT01154192|EG002|Reported Event|Oligomenorrhea Group|Not included in the study
11020302|NCT01154218|BG000|Baseline|Entire Study Population|Includes participants randomized to receive any treatment (crizotinib 250 mg IRT fasted first, crizotinib 250 mg PIC fasted first, crizotinib 250 mg CIC fasted first and crizotinib 250 mg CIC fed).
11020303|NCT01154218|FG000|Participant Flow|Crizotinib 250 mg IRT Fasted, PIC Fasted, CIC Fasted, CIC Fed|Single oral dose of crizotinib 250 milligram (mg) immediate release tablet (IRT) in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg powder in capsule (PIC) in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg commercial image capsule (CIC) in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fed state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
11020304|NCT01154218|FG001|Participant Flow|Crizotinib 250 mg PIC Fasted, CIC Fed, IRT Fasted, CIC Fasted|Single oral dose of crizotinib 250 mg PIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in second intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
11020305|NCT01154218|FG002|Participant Flow|Crizotinib 250 mg CIC Fasted, IRT Fasted, CIC Fed, PIC Fasted|Single oral dose of crizotinib 250 mg CIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in third intervention period; and single oral dose of crizotinib 250 mg PIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
11020306|NCT01154218|FG003|Participant Flow|Crizotinib 250 mg CIC Fed, CIC Fasted, PIC Fasted, IRT Fasted|Single oral dose of crizotinib 250 mg CIC in fed state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg PIC in fasted state in third intervention period; and single oral dose of crizotinib 250 mg IRT in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
11020307|NCT01154218|OG000|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
11148618|NCT01865708|OG000|Outcome|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
11020308|NCT01154218|OG001|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
11020309|NCT01154218|OG002|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
11020310|NCT01154218|OG003|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
11020311|NCT01154218|EG000|Reported Event|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
11020312|NCT01154218|EG001|Reported Event|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
11020313|NCT01154218|EG002|Reported Event|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
11020314|NCT01154218|EG003|Reported Event|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
11020315|NCT01154231|BG000|Baseline|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician's discretion.
11020316|NCT01154231|FG000|Participant Flow|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician's discretion.
11020317|NCT01154231|OG000|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician's discretion.
11020318|NCT01154231|EG000|Reported Event|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician's discretion.
11020319|NCT01154283|BG000|Baseline|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
11020320|NCT01154283|BG001|Baseline|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
11020321|NCT01154283|BG002|Baseline|Total|Total of all reporting groups
11020322|NCT01154283|FG000|Participant Flow|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
11020323|NCT01154283|FG001|Participant Flow|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
11020324|NCT01154283|OG000|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
11020325|NCT01154283|OG001|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
11020326|NCT01154283|EG000|Reported Event|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
11020327|NCT01154283|EG001|Reported Event|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
11020328|NCT01154296|BG000|Baseline|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
11020329|NCT01154296|BG001|Baseline|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
11020330|NCT01154296|BG002|Baseline|Total|Total of all reporting groups
11066199|NCT01391000|BG001|Baseline|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
11066200|NCT01391000|BG002|Baseline|Total|Total of all reporting groups
11020331|NCT01154296|FG000|Participant Flow|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
11020332|NCT01154296|FG001|Participant Flow|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
11020333|NCT01154296|OG000|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
11020334|NCT01154296|OG001|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
11020335|NCT01154296|EG000|Reported Event|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
11020336|NCT01154296|EG001|Reported Event|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
11020337|NCT01154322|BG000|Baseline|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
11020338|NCT01154322|FG000|Participant Flow|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
11020339|NCT01154322|OG000|Outcome|Currently-used Mask|Baseline AHI prior to Pixi mask use
11020340|NCT01154322|OG000|Outcome|Pixi Mask|AHI with Pixi mask
11020341|NCT01154322|EG000|Reported Event|Overall Study|
11020342|NCT01154452|BG000|Baseline|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
11020343|NCT01154452|BG001|Baseline|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
11020344|NCT01154452|BG002|Baseline|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
11020345|NCT01154452|BG003|Baseline|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
11020346|NCT01154452|BG004|Baseline|Total|Total of all reporting groups
11020347|NCT01154452|FG000|Participant Flow|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
11020348|NCT01154452|FG001|Participant Flow|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
11020349|NCT01154452|FG002|Participant Flow|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
11020350|NCT01154452|FG003|Participant Flow|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
11020351|NCT01154452|OG000|Outcome|All Phase Ib Participants|All Phase Ib Participants
11020352|NCT01154452|OG000|Outcome|Arm I (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-21.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11020353|NCT01154452|OG001|Outcome|Arm II (Vismodegib and Gamma-secretase Inhibitor RO4929097)|"Patients receive vismodegib PO and gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-21.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11020354|NCT01154452|OG000|Outcome|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
11020355|NCT01154452|OG001|Outcome|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
11020356|NCT01154452|OG002|Outcome|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
11020357|NCT01154452|OG003|Outcome|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
11020358|NCT01154452|EG000|Reported Event|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
11020359|NCT01154452|EG001|Reported Event|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
11020360|NCT01154452|EG002|Reported Event|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
11020361|NCT01154452|EG003|Reported Event|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
11020362|NCT01154634|BG000|Baseline|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
11020363|NCT01154634|BG001|Baseline|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
11020364|NCT01154634|BG002|Baseline|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
11020365|NCT01154634|BG003|Baseline|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
11020366|NCT01154634|BG004|Baseline|Total|Total of all reporting groups
11020367|NCT01154634|FG000|Participant Flow|First 5 mg, Then Placebo, Then 16 mg, Then 40 mg|period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.
11225681|NCT02370004|EG000|Reported Event|Resistive Flexibility and Strength Training|"Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner.~Resistive Flexibility and Strength Training: RFST is a physical therapy technique where a certified practitioner extends or flexes a joint with the subject actively resists the motion applied by the practitioner.~During the RFST treatment a subject will lie on a massage table while the practitioner holds the subject's arm or leg and flexes or extends the limb, instructing the patient to resist the flexion or extension produced by the practitioner. The process is repeated a number of times for each muscle while varying joint positions."
11225682|NCT02370043|BG000|Baseline|Overall Study|
11020368|NCT01154634|FG001|Participant Flow|First 40 mg, Then 16 mg, Then Placebo, Then 5 mg|period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.
11020369|NCT01154634|FG002|Participant Flow|First 16 mg, Then 5 mg, Then 40 mg, Then Placebo|period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.
11020370|NCT01154634|FG003|Participant Flow|First Placebo, Then 40 mg, Then 5 mg, Then 16 mg|period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg
11020371|NCT01154634|OG000|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
11020372|NCT01154634|OG001|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
11020373|NCT01154634|OG002|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
11020374|NCT01154634|OG003|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
11020375|NCT01154634|EG000|Reported Event|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
11020376|NCT01154634|EG001|Reported Event|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
11020377|NCT01154634|EG002|Reported Event|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
11020378|NCT01154634|EG003|Reported Event|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
11020379|NCT01154673|BG000|Baseline|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
11020380|NCT01154673|BG001|Baseline|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
11020381|NCT01154673|BG002|Baseline|Total|Total of all reporting groups
11020382|NCT01154673|FG000|Participant Flow|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID and endpoint is measured at 48 weeks"
11020383|NCT01154673|FG001|Participant Flow|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) and endpoint is measured at 48 weeks
11020384|NCT01154673|OG000|Outcome|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
11020385|NCT01154673|OG001|Outcome|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
11020386|NCT01154673|EG000|Reported Event|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
11225683|NCT02370043|FG000|Participant Flow|Sequence: 15 mg/Placebo/1200 mg/Placebo (Fed)|
11225684|NCT02370043|FG001|Participant Flow|Sequence: 15 mg KQ791/195 mg/Placebo/195 mg (Fed)|
11020387|NCT01154673|EG001|Reported Event|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
11020388|NCT01154699|BG000|Baseline|Asthma Only|Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
11020389|NCT01154699|BG001|Baseline|Asthma + OSA|Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
11020390|NCT01154699|BG002|Baseline|Total|Total of all reporting groups
11020391|NCT01154699|FG000|Participant Flow|Usual Care First, Then Bilevel PAP|"Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period. After a Washout Period of an additional 4 weeks of usual care, they will then start Bilevel PAP therapy for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests."
11020392|NCT01154699|FG001|Participant Flow|Bilevel PAP First, Then Usual Care|"Subjects will begin the study by starting on Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests. After a 4 week Washout Period of usual care, they will start a Usual Care period for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period."
11020393|NCT01154699|OG000|Outcome|Usual Care|Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
11020394|NCT01154699|OG001|Outcome|Bilevel PAP|Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
11020395|NCT01154699|OG000|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
11020396|NCT01154699|OG001|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
11020397|NCT01154699|EG000|Reported Event|Asthma Only|Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
11020398|NCT01154699|EG001|Reported Event|Asthma + OSA|Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
11020399|NCT01154751|BG000|Baseline|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
11020400|NCT01154751|FG000|Participant Flow|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
11020401|NCT01154751|OG000|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
11020402|NCT01154751|EG000|Reported Event|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
11020403|NCT01154816|BG000|Baseline|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
11020404|NCT01154816|BG001|Baseline|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
11020405|NCT01154816|BG002|Baseline|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
11020406|NCT01154816|BG003|Baseline|Recurrent Osteosarcoma|Experimental: Arm 4
11020407|NCT01154816|BG004|Baseline|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
11020408|NCT01154816|BG005|Baseline|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
11020409|NCT01154816|BG006|Baseline|Childhood Hepatoblastoma|Experimental: Arm 7
11020410|NCT01154816|BG007|Baseline|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
11020411|NCT01154816|BG008|Baseline|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
11020412|NCT01154816|BG009|Baseline|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
11020413|NCT01154816|BG010|Baseline|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
11020414|NCT01154816|BG011|Baseline|Rhaboid Malignancy|Experimental: Arm 12
11020415|NCT01154816|BG012|Baseline|Total|Total of all reporting groups
11020416|NCT01154816|FG000|Participant Flow|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
11020417|NCT01154816|FG001|Participant Flow|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
11020418|NCT01154816|FG002|Participant Flow|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
11020419|NCT01154816|FG003|Participant Flow|Recurrent Osteosarcoma|Experimental: Arm 4
11020420|NCT01154816|FG004|Participant Flow|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
11020421|NCT01154816|FG005|Participant Flow|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
11020422|NCT01154816|FG006|Participant Flow|Childhood Hepatoblastoma|Experimental: Arm 7
11020423|NCT01154816|FG007|Participant Flow|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
11020424|NCT01154816|FG008|Participant Flow|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
11020425|NCT01154816|FG009|Participant Flow|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
11020426|NCT01154816|FG010|Participant Flow|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
11020427|NCT01154816|FG011|Participant Flow|Rhaboid Malignancy|Experimental: Arm 12
11020428|NCT01154816|OG000|Outcome|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
11020429|NCT01154816|OG001|Outcome|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
11020430|NCT01154816|OG002|Outcome|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
11020431|NCT01154816|OG003|Outcome|Recurrent Osteosarcoma|Experimental: Arm 4
11020432|NCT01154816|OG004|Outcome|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
11020433|NCT01154816|OG005|Outcome|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
11020434|NCT01154816|OG006|Outcome|Childhood Hepatoblastoma|Experimental: Arm 7
11020435|NCT01154816|OG007|Outcome|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
11225685|NCT02370043|FG002|Participant Flow|Sequence: Placebo/195 mg/1200 mg/195 mg (Fed)|
11225686|NCT02370043|FG003|Participant Flow|Sequence: 60 mg/Placebo/1800 mg|
11225687|NCT02370043|FG004|Participant Flow|Sequence: 60 mg/600 mg/Placebo|
11225688|NCT02370043|FG005|Participant Flow|Sequence: Placebo/600 mg/1800 mg|
11225689|NCT02370043|OG000|Outcome|15 mg KQ-791 (Fasting)|
11225690|NCT02370043|OG001|Outcome|60 mg KQ-791 (Fasting)|
11225691|NCT02370043|OG002|Outcome|195 mg KQ-791 (Fasting)|
11225692|NCT02370043|OG003|Outcome|195 mg KQ-791 (Fed)|
11020436|NCT01154816|OG008|Outcome|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
11225693|NCT02370043|OG004|Outcome|600 mg KQ-791 (Fasting)|
10849318|NCT00295854|EG000|Reported Event|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
11020437|NCT01154816|OG009|Outcome|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
11020438|NCT01154816|OG010|Outcome|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
11020439|NCT01154816|OG011|Outcome|Rhaboid Malignancy|Experimental: Arm 12
11020440|NCT01154816|OG000|Outcome|All Patients|All patients
11020441|NCT01154816|OG000|Outcome|All Patients|All patients.
11020442|NCT01154816|EG000|Reported Event|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
11020443|NCT01154816|EG001|Reported Event|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
11020444|NCT01154816|EG002|Reported Event|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
11020445|NCT01154816|EG003|Reported Event|Recurrent Osteosarcoma|Experimental: Arm 4
11020446|NCT01154816|EG004|Reported Event|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
11020447|NCT01154816|EG005|Reported Event|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
11020448|NCT01154816|EG006|Reported Event|Childhood Hepatoblastoma|Experimental: Arm 7
11225694|NCT02370043|OG005|Outcome|1200 mg KQ-791 (Fasting)|
11225695|NCT02370043|OG006|Outcome|1800 mg Kq-791 (Fasting)|
11225696|NCT02370043|OG007|Outcome|Placebo (Fed)|
11225697|NCT02370043|OG008|Outcome|Placebo (Fasting)|
11225698|NCT02370043|OG000|Outcome|195 mg KQ-791|Food Effect (Fed/Fasting)
11225699|NCT02370043|OG000|Outcome|15 mg KQ-791 (Fasting)|12-24 hours post-dose
11225700|NCT02370043|OG001|Outcome|60 mg KQ-791 (Fasting)|12-24 hours post-dose
11225701|NCT02370043|OG002|Outcome|195 mg KQ-791 (Fasting)|12-24 hours post-dose
11225702|NCT02370043|OG003|Outcome|195 mg KQ-791 (Fed)|12-24 hours post dose
11225703|NCT02370043|OG004|Outcome|600 mg KQ-791 (Fasting)|12-24 hours post dose
11225704|NCT02370043|OG005|Outcome|1200 mg KQ-791 (Fasting)|12-24 hours post-dose
11225705|NCT02370043|OG006|Outcome|1800 mg Kq-791 (Fasting)|12-24 hours post-dose
11225706|NCT02370043|EG000|Reported Event|15 mg KQ-791 (Fasting)|
11225707|NCT02370043|EG001|Reported Event|60 mg KQ-791 (Fasting)|
11225708|NCT02370043|EG002|Reported Event|195 mg KQ-791 (Fasting)|
11225709|NCT02370043|EG003|Reported Event|195 mg KQ-791 (Fed)|
11225710|NCT02370043|EG004|Reported Event|600 mg KQ-791 (Fasting)|
11225711|NCT02370043|EG005|Reported Event|1200 mg KQ-791 (Fasting)|
11225712|NCT02370043|EG006|Reported Event|1800 mg Kq-791 (Fasting)|
11225713|NCT02370043|EG007|Reported Event|Placebo (Fasting)|
11225714|NCT02370043|EG008|Reported Event|Placebo (Fed)|
11225715|NCT02370056|BG000|Baseline|3D Visualization|"3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.~This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.~3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode"
11225716|NCT02370056|BG001|Baseline|2D Visualization|"2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.~This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.~2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode"
11225717|NCT02370056|BG002|Baseline|Total|Total of all reporting groups
11225718|NCT02370056|FG000|Participant Flow|3D Visualization|"3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.~This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.~3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode"
11225719|NCT02370056|FG001|Participant Flow|2D Visualization|"2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.~This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.~2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode"
11341291|NCT03680521|FG001|Participant Flow|Sitravatinib 80 mg|Participants received sitravatinib orally, once a day, at a dose of 80 mg for 2 weeks (segment 1). Then, the participants continued to receive sitravatinib in combination with nivolumab 240 mg administered as an intravenous (IV) infusion every 2 weeks, for a maximum of 6 additional weeks (segment 2).
11020449|NCT01154816|EG007|Reported Event|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
11020450|NCT01154816|EG008|Reported Event|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
11020451|NCT01154816|EG009|Reported Event|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
11020452|NCT01154816|EG010|Reported Event|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
11020453|NCT01154816|EG011|Reported Event|Rhaboid Malignancy|Experimental: 12
11020454|NCT01154985|BG000|Baseline|Placebo|Placebo: Placebo three times a day (TID) for 365 days
11020455|NCT01154985|BG001|Baseline|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
11020456|NCT01154985|BG002|Baseline|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
11020457|NCT01154985|BG003|Baseline|Total|Total of all reporting groups
11020458|NCT01154985|FG000|Participant Flow|Placebo|Placebo: Placebo three times a day (TID) for 365 days
11020459|NCT01154985|FG001|Participant Flow|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
11020460|NCT01154985|FG002|Participant Flow|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
11020461|NCT01154985|OG000|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
11020462|NCT01154985|OG001|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
11020463|NCT01154985|OG002|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
11020464|NCT01154985|EG000|Reported Event|Placebo|Placebo: Placebo three times a day (TID) for 365 days
11020465|NCT01154985|EG001|Reported Event|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
11020466|NCT01154985|EG002|Reported Event|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
11020467|NCT01155011|BG000|Baseline|MIPARC Intervention|"Intervention participants engage in group education session, individual phone counseling calls and group walks for the first 6 months. The telephone counseling calls will be eliminated after 3 months.~Participants monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. They receive support from peer leaders. The peer leaders also receive advocacy training from a non-profit advocacy organization to conduct walk audits of their CCRC and help mobilize participants to make changes to their community that will increase or improve the opportunities for physical activity."
11020468|NCT01155011|BG001|Baseline|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
11020469|NCT01155011|BG002|Baseline|Total|Total of all reporting groups
11020470|NCT01155011|FG000|Participant Flow|MIPARC Intervention|"The intervention will focus on increasing light to moderate PA, primarily promoting walking by gradually increasing participants' daily step counts.~Participants will monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. Participants will attend group educational sessions and group walks, receive phone counseling calls from UCSD counselors, receive support from peer mentors, In order to increase the sustainability of the project, MIPARC will focus on addressing on-site policies and neighborhood factors that are barriers to physical activity."
11020471|NCT01155011|FG001|Participant Flow|Health Education Control|The control group will receive an active health education intervention. The education curriculum will involve both lectures and mailed materials. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
11020472|NCT01155011|OG000|Outcome|MIPARC Intervention|Intervention participants received group education sessions, group walks, phone counseling and support from peer leaders.
11020473|NCT01155011|OG001|Outcome|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA.
11020474|NCT01155011|OG000|Outcome|MIPARC Intervention|Participants received group educations sessions, group walks, phone counseling, support from peer leaders.
11020475|NCT01155011|OG001|Outcome|Health Education Control|The control group will receive an active health education intervention.. The lectures will be delivered to match the MIPARC intervention schedule.
11020476|NCT01155011|OG000|Outcome|MIPARC Intervention|"Intervention participants engage in group education session, individual phone counseling calls and group walks for the first 6 months. The telephone counseling calls will be eliminated after 3 months.~Participants monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. They receive support from peer leaders."
11020477|NCT01155011|OG001|Outcome|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
11020478|NCT01155011|EG000|Reported Event|MIPARC Intervention|Intervention participants received group education sessions, group walks, phone counseling and support from peer leaders.
11020479|NCT01155011|EG001|Reported Event|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA.
11020480|NCT01155024|BG000|Baseline|Entire Study Population|Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first
11020481|NCT01155024|FG000|Participant Flow|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
11020482|NCT01155024|FG001|Participant Flow|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
11225720|NCT02370056|OG000|Outcome|3D Visualization|"3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.~This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.~3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode"
11225721|NCT02370056|OG001|Outcome|2D Visualization|"2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.~This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.~2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode"
11225722|NCT02370056|EG000|Reported Event|3D Visualization|"3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.~This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.~3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode"
10886233|NCT00492856|OG002|Outcome|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
11020483|NCT01155024|OG000|Outcome|Traditional Socket|Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
11020484|NCT01155024|OG001|Outcome|Direct Manufactured Socket|Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
11020485|NCT01155024|OG000|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
11020486|NCT01155024|EG000|Reported Event|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
11020487|NCT01155024|EG001|Reported Event|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
11020488|NCT01155050|BG000|Baseline|Tele-health Home Monitoring|"Participants will use the tele-health monitoring equipment to measure daily weight.~Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants."
11020489|NCT01155050|BG001|Baseline|Self-Directed Group|Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.
11020490|NCT01155050|BG002|Baseline|TrestleTree Telephone Coaching|"Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.~TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."
11225723|NCT02370056|EG001|Reported Event|2D Visualization|"2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.~This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.~2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode"
11225724|NCT02370095|BG000|Baseline|Treprostinil Inhalation Solution|"Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.~Treprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product"
11225725|NCT02370095|BG001|Baseline|Placebo|"Placebo administration will be administered as above for the active arm~Placebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil"
11225726|NCT02370095|BG002|Baseline|Total|Total of all reporting groups
11020491|NCT01155050|BG003|Baseline|Home Monitoring + Telephone Coach|"System to track stage of change in weight loss.~Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach."
11020492|NCT01155050|BG004|Baseline|Total|Total of all reporting groups
11020493|NCT01155050|FG000|Participant Flow|Tele-health Home Monitoring|"Participants will use the tele-health monitoring equipment to measure daily weight.~Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants."
11020494|NCT01155050|FG001|Participant Flow|Self-Directed Group|Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.
11020495|NCT01155050|FG002|Participant Flow|TrestleTree Telephone Coaching|"Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.~TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."
11020496|NCT01155050|FG003|Participant Flow|Home Monitoring + Telephone Coach|"System to track stage of change in weight loss.~Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach."
11020497|NCT01155050|OG000|Outcome|Tele-health Home Monitoring|"Participants will use the tele-health monitoring equipment to measure daily weight.~Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants."
11020498|NCT01155050|OG001|Outcome|Self-Directed Group|Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.
11020499|NCT01155050|OG002|Outcome|TrestleTree Telephone Coaching|"Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.~TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."
11020500|NCT01155050|OG003|Outcome|Home Monitoring + Telephone Coach|"System to track stage of change in weight loss.~Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach."
11020501|NCT01155050|EG000|Reported Event|Tele-health Home Monitoring|"Participants will use the tele-health monitoring equipment to measure daily weight.~Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants."
11020502|NCT01155050|EG001|Reported Event|Self-Directed Group|Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.
11020503|NCT01155050|EG002|Reported Event|TrestleTree Telephone Coaching|"Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.~TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."
11020504|NCT01155050|EG003|Reported Event|Home Monitoring + Telephone Coach|"System to track stage of change in weight loss.~Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach."
11020505|NCT01155063|BG000|Baseline|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
11020506|NCT01155063|FG000|Participant Flow|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 milligram (mg) oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
11020507|NCT01155063|OG000|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
11020508|NCT01155063|EG000|Reported Event|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
11020509|NCT01155141|BG000|Baseline|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
11020510|NCT01155141|FG000|Participant Flow|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
11020511|NCT01155141|OG000|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
11020512|NCT01155141|EG000|Reported Event|H.P. Acthar Gel|Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
11020513|NCT01155154|BG000|Baseline|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
11020514|NCT01155154|BG001|Baseline|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
11020515|NCT01155154|BG002|Baseline|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
11020516|NCT01155154|BG003|Baseline|Total|Total of all reporting groups
11020517|NCT01155154|FG000|Participant Flow|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
11020518|NCT01155154|FG001|Participant Flow|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
11020519|NCT01155154|FG002|Participant Flow|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
11020520|NCT01155154|OG000|Outcome|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
11020521|NCT01155154|OG001|Outcome|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
11020522|NCT01155154|OG002|Outcome|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
11020523|NCT01155154|EG000|Reported Event|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
11020524|NCT01155154|EG001|Reported Event|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
11020525|NCT01155154|EG002|Reported Event|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
11020526|NCT01155167|BG000|Baseline|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
11020527|NCT01155167|BG001|Baseline|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
11020528|NCT01155167|BG002|Baseline|Total|Total of all reporting groups
11020529|NCT01155167|FG000|Participant Flow|Placebo|Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
11020530|NCT01155167|FG001|Participant Flow|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
11020531|NCT01155167|OG000|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
11020532|NCT01155167|OG001|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
11020533|NCT01155167|EG000|Reported Event|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
11020534|NCT01155167|EG001|Reported Event|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
11020535|NCT01155180|BG000|Baseline|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
11020536|NCT01155180|BG001|Baseline|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo-daily self injections for 6 months"
11020537|NCT01155180|BG002|Baseline|Total|Total of all reporting groups
11020538|NCT01155180|FG000|Participant Flow|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
11020539|NCT01155180|FG001|Participant Flow|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
11020540|NCT01155180|OG000|Outcome|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
11020541|NCT01155180|OG001|Outcome|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
11020542|NCT01155180|EG000|Reported Event|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
11020543|NCT01155180|EG001|Reported Event|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
11020544|NCT01155193|BG000|Baseline|Palivizumab Registry 02/03 - 06/07|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.
11020545|NCT01155193|BG001|Baseline|Palivizumab Registry 07/08|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.
11020546|NCT01155193|BG002|Baseline|Palivizumab Registry 08/09|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
11020547|NCT01155193|BG003|Baseline|Palivizumab Registry 09/10 - 15/16|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.
11020548|NCT01155193|BG004|Baseline|Total|Total of all reporting groups
11020549|NCT01155193|FG000|Participant Flow|Palivizumab Registry 02/03 - 06/07|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 until 30 June 2007.
11020550|NCT01155193|FG001|Participant Flow|Palivizumab Registry 07/08|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.
11020551|NCT01155193|FG002|Participant Flow|Palivizumab Registry 08/09|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
11020552|NCT01155193|FG003|Participant Flow|Palivizumab Registry 09/10 - 15/16|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.
11020553|NCT01155193|OG000|Outcome|Palivizumab Registry 02/03 - 06/07|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.
11020554|NCT01155193|OG001|Outcome|Palivizumab Registry 07/08|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.
11020555|NCT01155193|OG002|Outcome|Palivizumab Registry 08/09|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
11020556|NCT01155193|OG003|Outcome|Palivizumab Registry 09/10 - 15/16|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.
11020557|NCT01155193|OG000|Outcome|Palivizumab Registry 08/09|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
11020558|NCT01155193|OG001|Outcome|Registry 09/10 - 15/16 Hospitalization Associated With RSV|Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization associated with RSV infection.
11020559|NCT01155193|OG002|Outcome|Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated|Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
11020560|NCT01155193|OG000|Outcome|Palivizumab Registry 02/03 - 06/07|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 until 30 June 2007.
11020561|NCT01155193|OG002|Outcome|Palivizumab Registry 08/09|"Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from~01 September 2008 to 30 June 2009."
11020562|NCT01155193|OG003|Outcome|Registry 09/10 - 15/16 Hospitalization Associated With RSV|Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was associated with RSV infection.
11020563|NCT01155193|OG004|Outcome|Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated|Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
11020564|NCT01155193|OG001|Outcome|Palivizumab Registry 09/10 - 15/16|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.
11020565|NCT01155193|EG000|Reported Event|Palivizumab|Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season (September to June) from 2002 to 2016.
11020566|NCT01155219|BG000|Baseline|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
11020567|NCT01155219|BG001|Baseline|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
11020568|NCT01155219|BG002|Baseline|Total|Total of all reporting groups
11020569|NCT01155219|FG000|Participant Flow|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
11020570|NCT01155219|FG001|Participant Flow|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
11020571|NCT01155219|OG000|Outcome|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
11020572|NCT01155219|OG001|Outcome|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
11020573|NCT01155219|EG000|Reported Event|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % unpreserved timolol maleate gel)~One drop in the conjunctival sac of each eye in the morning"
11020574|NCT01155219|EG001|Reported Event|Xalatan®|"Latanoprost~One drop in the conjunctival sac of each eye in the evening"
11020575|NCT01155284|BG000|Baseline|Sitagliptin and Lansoprazole|Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
11020576|NCT01155284|BG001|Baseline|Placebo|Matching placebo will be given daily for 12 months. Participants were then followed for an additional 12 months.
11020577|NCT01155284|BG002|Baseline|Total|Total of all reporting groups
11020578|NCT01155284|FG000|Participant Flow|Sitagliptin and Lansoprazole|Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
11020579|NCT01155284|FG001|Participant Flow|Placebo|Placebo: Matching placebo was given daily for 12 months.
11020580|NCT01155284|OG000|Outcome|Sitagliptin and Lansoprazole|"Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) given daily for 12 months.~Subjects age 11-17 years at Visit 2 will take 1 capsule once daily~Subjects age 18-45 years at Visit 2 will take 2 capsules once daily"
11020581|NCT01155284|OG001|Outcome|Placebo|Matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
11020582|NCT01155284|OG000|Outcome|Sitagliptin and Lansoprazole|Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
11020583|NCT01155284|OG001|Outcome|Placebo|Matching placebo will be given daily for 12 months. Participants were then followed for an additional 12 months.
11020584|NCT01155284|EG000|Reported Event|Sitagliptin and Lansoprazole|"Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) taken for 12 months.~Subjects age 11-17 years at Visit 2 will take 1 capsule once daily~Subjects age 18-45 years at Visit 2 will take 2 capsules once daily"
10886234|NCT00492856|OG003|Outcome|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
10886235|NCT00492856|OG000|Outcome|Post-consolidation Therapy Arm I|"Patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.~mercaptopurine: Given orally~methotrexate: Given orally~tretinoin: Given orally"
10886236|NCT00492856|OG001|Outcome|Post-consolidation Therapy Arm II|Patients receive no further chemotherapy. (Randomization and observation arm closed as of 05/27/10)
10886237|NCT00492856|EG000|Reported Event|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
10886238|NCT00492856|EG001|Reported Event|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
10886239|NCT00492856|EG002|Reported Event|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
10886240|NCT00492856|EG003|Reported Event|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
10886241|NCT00492921|BG000|Baseline|Cyclophosphamide|Treatment with cyclophosphamide 50 mg/kg/d x 2 days, then dose adjusted according to continuous reassessment model according to toxicities until MTD found.
10886242|NCT00492921|FG000|Participant Flow|Cyclophosphamide 50 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 1 day.
10886243|NCT00492921|FG001|Participant Flow|Cyclophosphamide 100 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 2 days.
10886244|NCT00492921|FG002|Participant Flow|Cyclophosphamide 150 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 3 days.
10886245|NCT00492921|OG000|Outcome|Cyclophosphamide 50 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 1 day.
10886246|NCT00492921|OG001|Outcome|Cyclophosphamide 100 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 2 days.
10886247|NCT00492921|OG002|Outcome|Cyclophosphamide 150 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 3 days.
10886248|NCT00492921|EG000|Reported Event|Cyclophosphamide 50 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 1 day.
10886249|NCT00492921|EG001|Reported Event|Cyclophosphamide 100 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 2 days.
10886250|NCT00492921|EG002|Reported Event|Cyclophosphamide 150 mg/kg|Treatment with cyclophosphamide 50 mg/kg/d x 3 days.
10886251|NCT00492973|BG000|Baseline|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
10886252|NCT00492973|BG001|Baseline|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
10886253|NCT00492973|BG002|Baseline|Total|Total of all reporting groups
10886254|NCT00492973|FG000|Participant Flow|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
10886255|NCT00492973|FG001|Participant Flow|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
10886256|NCT00492973|OG000|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
10886257|NCT00492973|OG001|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
10886258|NCT00492973|EG000|Reported Event|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
10886259|NCT00492973|EG001|Reported Event|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
10886260|NCT00493012|BG000|Baseline|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
10886261|NCT00493012|BG001|Baseline|Placebo Comparator|A daily placebo oil is given for year
10886262|NCT00493012|BG002|Baseline|Total|Total of all reporting groups
10886263|NCT00493012|FG000|Participant Flow|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
10886264|NCT00493012|FG001|Participant Flow|Placebo Comparator|A daily placebo oil is given for year
10886265|NCT00493012|OG000|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
10886266|NCT00493012|OG001|Outcome|Placebo Comparator|A daily placebo oil is given for year
10886267|NCT00493012|EG000|Reported Event|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
10886268|NCT00493012|EG001|Reported Event|Placebo Comparator|A daily placebo oil is given for year
10886269|NCT00493038|BG000|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
10886270|NCT00493038|BG001|Baseline|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
10886271|NCT00493038|BG002|Baseline|Total|Total of all reporting groups
11020585|NCT01155284|EG001|Reported Event|Placebo|Matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
11020586|NCT01155323|BG000|Baseline|Total Number of Participants|This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.
11020587|NCT01155323|FG000|Participant Flow|Etafilcon A/Omafilcon A|etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
11020588|NCT01155323|FG001|Participant Flow|Omafilcon A/Etafilcon A|omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
11020589|NCT01155323|OG000|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
11020590|NCT01155323|OG001|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
11020591|NCT01155323|EG000|Reported Event|Etafilcon A|soft contact lens replaced daily, worn for one week.
11020592|NCT01155323|EG001|Reported Event|Omafilcon A|soft contact lens replaced daily, worn for one week.
11020593|NCT01155336|BG000|Baseline|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
11020594|NCT01155336|BG001|Baseline|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
10886272|NCT00493038|FG000|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
11020595|NCT01155336|BG002|Baseline|Total|Total of all reporting groups
11020596|NCT01155336|FG000|Participant Flow|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
11020597|NCT01155336|FG001|Participant Flow|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
11020598|NCT01155336|OG000|Outcome|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
11020599|NCT01155336|OG001|Outcome|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
11020600|NCT01155336|EG000|Reported Event|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
11020601|NCT01155336|EG001|Reported Event|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
11020602|NCT01155466|BG000|Baseline|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
11020603|NCT01155466|BG001|Baseline|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
11020604|NCT01155466|BG002|Baseline|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
11020605|NCT01155466|BG003|Baseline|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
11020606|NCT01155466|BG004|Baseline|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
11020607|NCT01155466|BG005|Baseline|Total|Total of all reporting groups
11020608|NCT01155466|FG000|Participant Flow|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
11020609|NCT01155466|FG001|Participant Flow|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
11020610|NCT01155466|FG002|Participant Flow|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
11020611|NCT01155466|FG003|Participant Flow|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
11020612|NCT01155466|FG004|Participant Flow|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
11020613|NCT01155466|OG000|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
11020614|NCT01155466|OG001|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
11020615|NCT01155466|OG002|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
11020616|NCT01155466|OG003|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
11020617|NCT01155466|OG004|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
11225727|NCT02370095|FG000|Participant Flow|Treprostinil Inhalation Solution|"Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.~Treprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product"
10849717|NCT00297648|OG000|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
11225728|NCT02370095|FG001|Participant Flow|Placebo|"Placebo administration will be administered as above for the active arm~Placebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil"
10849718|NCT00297648|EG000|Reported Event|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
10849719|NCT00297778|BG000|Baseline|Placebo|Placebo tablet matching active treatment
10849720|NCT00297778|BG001|Baseline|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
10849721|NCT00297778|BG002|Baseline|Total|Total of all reporting groups
10849722|NCT00297778|FG000|Participant Flow|Placebo|Placebo tablet matching active treatment
10849723|NCT00297778|FG001|Participant Flow|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
10849724|NCT00297778|OG000|Outcome|Placebo|Placebo tablet matching active treatment
10849725|NCT00297778|OG001|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
10849726|NCT00297778|EG000|Reported Event|Placebo|Placebo tablet matching active treatment
10849727|NCT00297778|EG001|Reported Event|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
10849728|NCT00297830|BG000|Baseline|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
10849729|NCT00297830|BG001|Baseline|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
10849730|NCT00297830|BG002|Baseline|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
10849731|NCT00297830|BG003|Baseline|Total|Total of all reporting groups
10849732|NCT00297830|FG000|Participant Flow|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
10849733|NCT00297830|FG001|Participant Flow|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
10849734|NCT00297830|FG002|Participant Flow|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
10849735|NCT00297830|OG000|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
10849736|NCT00297830|OG001|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
10849737|NCT00297830|OG002|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
10849738|NCT00297830|EG000|Reported Event|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
10849739|NCT00297830|EG001|Reported Event|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.https://register.clinicaltrials.gov/prs/html/results_definitions.html#Result_ParticipantFlow_Period_title
10849740|NCT00297830|EG002|Reported Event|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
10849741|NCT00297882|BG000|Baseline|1 Artemether-Lumefantrine|"Artemether-Lumefantrine , Amodiaquine-Artesunate: 1 Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).~2 Amodiaquine-ArtemetherD0(0H),D1(24H),D2(48H)- Artesunate 4mg/kg and Amodiaquine at 10mg/kg"
10849742|NCT00297882|BG001|Baseline|2 Amodiaquine-Artemether|"Artemether-Lumefantrine , Amodiaquine-Artesunate: 1 Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).~2 Amodiaquine-ArtemetherD0(0H),D1(24H),D2(48H)- Artesunate 4mg/kg and Amodiaquine at 10mg/kg"
10849743|NCT00297882|BG002|Baseline|Total|Total of all reporting groups
11020618|NCT01155466|EG000|Reported Event|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
11020619|NCT01155466|EG001|Reported Event|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
11020620|NCT01155466|EG002|Reported Event|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
11020621|NCT01155466|EG003|Reported Event|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
11020622|NCT01155466|EG004|Reported Event|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
11020623|NCT01155479|BG000|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11020624|NCT01155479|BG001|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11341292|NCT03680521|OG000|Outcome|Sitravatinib 120 mg|Participants received sitravatinib orally, once a day, at a dose of 120 mg for 2 weeks (segment 1). Then, the participants continued to receive sitravatinib in combination with nivolumab 240 mg administered as an intravenous (IV) infusion every 2 weeks, for a maximum of 6 additional weeks (segment 2).
11020625|NCT01155479|BG002|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11020626|NCT01155479|BG003|Baseline|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
11020627|NCT01155479|BG004|Baseline|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11020628|NCT01155479|BG005|Baseline|Total|Total of all reporting groups
11020629|NCT01155479|FG000|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11020630|NCT01155479|FG001|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11020631|NCT01155479|FG002|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11020632|NCT01155479|FG003|Participant Flow|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
11020633|NCT01155479|FG004|Participant Flow|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11020634|NCT01155479|OG000|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
11020635|NCT01155479|OG001|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
11020636|NCT01155479|OG002|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
11020637|NCT01155479|OG003|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
11020638|NCT01155479|OG004|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
11020639|NCT01155479|OG000|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
11020640|NCT01155479|OG001|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks. The number of participants analyzed (202) represents the number of randomized and treated participants with at least one post-treatment value.
11020641|NCT01155479|OG002|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks. The number of participants analyzed (200) represents the number of randomized and treated participants with at least one post-treatment value.
11020642|NCT01155479|OG003|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
11020643|NCT01155479|OG004|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
11020644|NCT01155479|OG004|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
11020645|NCT01155479|OG000|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
11020646|NCT01155479|OG001|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
11020647|NCT01155479|OG002|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
11020648|NCT01155479|OG003|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
11020649|NCT01155479|OG004|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
11148619|NCT01865708|EG000|Reported Event|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
11148620|NCT01865747|BG000|Baseline|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
11148621|NCT01865747|BG001|Baseline|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
11148622|NCT01865747|BG002|Baseline|Total|Total of all reporting groups
11148623|NCT01865747|FG000|Participant Flow|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
11148624|NCT01865747|FG001|Participant Flow|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
11148625|NCT01865747|OG000|Outcome|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
11148626|NCT01865747|OG001|Outcome|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
11148627|NCT01865747|EG000|Reported Event|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
11148628|NCT01865747|EG001|Reported Event|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
11148629|NCT01865812|BG000|Baseline|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
10886273|NCT00493038|FG001|Participant Flow|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
11020650|NCT01155479|EG000|Reported Event|Preladenant 2 mg - Part 1|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1).
11020651|NCT01155479|EG001|Reported Event|Preladenant 5 mg - Part 1|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1).
11020652|NCT01155479|EG002|Reported Event|Preladenant 10 mg - Part 1|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1).
11020653|NCT01155479|EG003|Reported Event|Placebo - Part 1|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1).
11020654|NCT01155479|EG004|Reported Event|Rasagiline - Part 1|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1).
11020655|NCT01155479|EG005|Reported Event|Preladenant 2 mg - Part 2|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2).
11020656|NCT01155479|EG006|Reported Event|Preladenant 5 mg - Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2).
11020657|NCT01155479|EG007|Reported Event|Preladenant 10 mg - Part 2|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2).
11148630|NCT01865812|FG000|Participant Flow|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
11148631|NCT01865812|OG000|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
11148632|NCT01865812|EG000|Reported Event|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
11148633|NCT01866098|BG000|Baseline|Placebo|"Oral placebo capsule taken once daily for 52 weeks~Placebo"
11148634|NCT01866098|BG001|Baseline|Naltrexone 25mg|"Oral Naltrexone 25mg capsule taken once daily for 52 weeks~Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study."
11020658|NCT01155479|EG008|Reported Event|Placebo/Preladenant 5 Mg-Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2).
11020659|NCT01155479|EG009|Reported Event|Rasagiline - Part 2|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).
11020660|NCT01155531|BG000|Baseline|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020661|NCT01155531|BG001|Baseline|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020662|NCT01155531|BG002|Baseline|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020663|NCT01155531|BG003|Baseline|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020664|NCT01155531|BG004|Baseline|Total|Total of all reporting groups
11020665|NCT01155531|FG000|Participant Flow|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020666|NCT01155531|FG001|Participant Flow|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11225729|NCT02370095|OG000|Outcome|Treprostinil Inhalation Solution|"Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.~Treprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product"
10886274|NCT00493038|OG000|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
11020667|NCT01155531|FG002|Participant Flow|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020668|NCT01155531|FG003|Participant Flow|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020669|NCT01155531|OG000|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020670|NCT01155531|OG001|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020671|NCT01155531|OG002|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020672|NCT01155531|OG003|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020673|NCT01155531|EG000|Reported Event|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020674|NCT01155531|EG001|Reported Event|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020675|NCT01155531|EG002|Reported Event|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020676|NCT01155531|EG003|Reported Event|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
11020677|NCT01155570|BG000|Baseline|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
11225730|NCT02370095|OG001|Outcome|Placebo|"Placebo administration will be administered as above for the active arm~Placebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil"
10886275|NCT00493038|OG001|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
11020678|NCT01155570|FG000|Participant Flow|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
11020679|NCT01155570|OG000|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
11020680|NCT01155570|OG000|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
11020681|NCT01155570|OG001|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
11020682|NCT01155570|EG000|Reported Event|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
11020683|NCT01155583|BG000|Baseline|Arm A (GFR>=60mL/Min) Dose Level DL 1|"Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~dexamethasone: Given orally~DNA methylation analysis: Correlative studies~gene expression analysis: Correlative studies~bone marrow aspiration: Correlative studies~immunohistochemistry staining method: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~flow cytometry: Correlative studies"
11020684|NCT01155583|BG001|Baseline|Arm A (GFR>=60mL/Min) Dose Level 2|"Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity~lenalidomide: Given orally~dexamethasone: Given orally~DNA methylation analysis: Correlative studies~gene expression analysis: Correlative studies~bone marrow aspiration: Correlative studies~immunohistochemistry staining method: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~flow cytometry: Correlative studies"
11020685|NCT01155583|BG002|Baseline|Arm A (GFR>=60mL/Min) Dose Level 3|Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020686|NCT01155583|BG003|Baseline|Arm A (GFR>=60mL/Min) Dose Level 4|Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020687|NCT01155583|BG004|Baseline|Arm A (GFR>=60mL/Min) Dose Level 5|Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020688|NCT01155583|BG005|Baseline|Arm B (GFR 30-59mL/Min - CKD) Dose Level -1|Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020689|NCT01155583|BG006|Baseline|Arm B (GFR 30-59mL/Min - CKD) Dose Level 1|Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week
11020690|NCT01155583|BG007|Baseline|Arm B (GFR 30-59mL/Min - CKD) Dose Level 2|Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week
11020691|NCT01155583|BG008|Baseline|Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW)|Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week
11020692|NCT01155583|BG009|Baseline|Total|Total of all reporting groups
11020693|NCT01155583|FG000|Participant Flow|Arm A (GFR>=60mL/Min) Dose Level DL 1|"Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week~Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity."
11020694|NCT01155583|FG001|Participant Flow|Arm A (GFR>=60mL/Min) Dose Level 2|Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020695|NCT01155583|FG002|Participant Flow|Arm A (GFR>=60mL/Min) Dose Level 3|Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020696|NCT01155583|FG003|Participant Flow|Arm A (GFR>=60mL/Min) Dose Level 4|Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020697|NCT01155583|FG004|Participant Flow|Arm A (GFR>=60mL/Min) Dose Level 5|"Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week~Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity."
11148635|NCT01866098|BG002|Baseline|Naltrexone 50mg|"Oral Naltrexone 50mg capsule taken once daily for 52 weeks~Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study."
11148636|NCT01866098|BG003|Baseline|Total|Total of all reporting groups
11148637|NCT01866098|FG000|Participant Flow|Placebo|"Oral placebo capsule taken once daily for 52 weeks~Placebo"
11148638|NCT01866098|FG001|Participant Flow|Naltrexone 25mg|"Oral Naltrexone 25mg capsule taken once daily for 52 weeks~Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study."
11020698|NCT01155583|FG005|Participant Flow|Arm B (GFR 30-59mL/Min - CKD) Dose Level -1|"Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week~Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity."
11020699|NCT01155583|FG006|Participant Flow|Arm B (GFR 30-59mL/Min - CKD) Dose Level 1|Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week
11020700|NCT01155583|FG007|Participant Flow|Arm B (GFR 30-59mL/Min - CKD) Dose Level 2|Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week
11020701|NCT01155583|FG008|Participant Flow|Phase II Arm A or B GFR >= 30mL/Min Expansion Dose (50 BIW)|Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week
11225731|NCT02370095|EG000|Reported Event|Treprostinil Inhalation Solution|"Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.~Treprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product"
11225732|NCT02370095|EG001|Reported Event|Placebo|"Placebo administration will be administered as above for the active arm~Placebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil"
10886276|NCT00493038|EG000|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
11020702|NCT01155583|OG000|Outcome|Arm A - Azacitidine/Lenalidomide/Dexamethasone|"Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC~lenalidomide: Given orally~dexamethasone: Given orally~DNA methylation analysis: Correlative studies~gene expression analysis: Correlative studies~bone marrow aspiration: Correlative studies~immunohistochemistry staining method: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~flow cytometry: Correlative studies"
11020703|NCT01155583|OG001|Outcome|Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone|"Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC~lenalidomide: Given orally~dexamethasone: Given orally~DNA methylation analysis: Correlative studies~gene expression analysis: Correlative studies~bone marrow aspiration: Correlative studies~immunohistochemistry staining method: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~flow cytometry: Correlative studies"
11020704|NCT01155583|OG000|Outcome|Overall Study - (Azacitidine/Lenalidomide/Dexamethasone)|Participants receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Participants also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Participants then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020705|NCT01155583|OG001|Outcome|Participants Who Received HTLD/HTLD-CKD|Participants treated with the HTLD and HTLD-CKD dose: Azacitidine 50mg/m2 2x week + Lenalidomide 25mg (or 10mg for CKD) d1-21 every 28d + Dexamethasone 40mg once a week
11020706|NCT01155583|OG001|Outcome|Participants Who Received HTLD/HTLD-CKD|Participants who received HTLD and HTLD-CKD dose: Azacitidine 50mg/m2 2x week + Lenalidomide 25mg (or 10mg for CKD) d1-21 every 28d + Dexamethasone 40mg once a week
11020707|NCT01155583|EG000|Reported Event|Arm A (GFR>=60mL/Min) Dose Level DL 1|"Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week~Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity."
11020708|NCT01155583|EG001|Reported Event|Arm A (GFR>=60mL/ Min) Dose Level 2|Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11066201|NCT01391000|FG000|Participant Flow|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
11225733|NCT02370121|BG000|Baseline|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
11225734|NCT02370121|BG001|Baseline|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
11225735|NCT02370121|BG002|Baseline|Total|Total of all reporting groups
10886277|NCT00493038|EG001|Reported Event|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
11020709|NCT01155583|EG002|Reported Event|Arm A (GFR>=60mL/ Min) Dose Level 3|Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020710|NCT01155583|EG003|Reported Event|Arm A (GFR>=60mL/ Min) Dose Level 4|Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11020711|NCT01155583|EG004|Reported Event|Arm A (GFR>=60mL/ Min) Dose Level 5|"Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week~Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity."
11020712|NCT01155583|EG005|Reported Event|Arm B (GFR 30-59mL/Min - CKD) Dose Level -1|"Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week~Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity."
11020713|NCT01155583|EG006|Reported Event|Arm B (GFR 30-59mL/Min - CKD) Dose Level 1|Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week
11020714|NCT01155583|EG007|Reported Event|Arm B (GFR 30-59mL/Min - CKD) Dose Level 2|Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week
11020715|NCT01155583|EG008|Reported Event|Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW)|Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week
11020716|NCT01155661|BG000|Baseline|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
11020717|NCT01155661|FG000|Participant Flow|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
11020718|NCT01155661|OG000|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
11020719|NCT01155661|OG000|Outcome|LY2216684 + SSRI|LY2216684: 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
11020720|NCT01155661|EG000|Reported Event|LY2216684 + SSRI Open-Label Phase|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI); included all enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.
11020721|NCT01155661|EG001|Reported Event|Discontinuation Phase|Included all enrolled participants who abruptly discontinued LY2216684 (edivoxetine) treatment either at the end of the study or after early withdrawal from the study and who did not discontinue from the study for the reason 'Lost to follow-up' at the discontinuation phase visit. All participants maintained their SSRI treatment at the stable dose during the discontinuation phase.
11020722|NCT01155726|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
11020723|NCT01155726|FG000|Participant Flow|Nelfilcon A, Masked, Unmasked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
11020724|NCT01155726|FG001|Participant Flow|Nelfilcon A, Masked, Partially Masked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
11020725|NCT01155726|FG002|Participant Flow|Etafilcon A, Masked, Unmasked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
10886278|NCT00493064|BG000|Baseline|Prospective Active Treatment|"Niacin 500mg TID PO for treatment of retinal vein occlusions.~Nicotinic acid: topical eye drops~Prednisolone acetate: topical eye drops"
11020726|NCT01155726|FG003|Participant Flow|Etafilcon A, Masked, Partially Masked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
11020727|NCT01155726|OG000|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
11020728|NCT01155726|OG001|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
11020729|NCT01155726|OG002|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
11020730|NCT01155726|OG003|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
11020731|NCT01155726|OG004|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
11020732|NCT01155726|OG005|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
11020733|NCT01155726|OG006|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
11020734|NCT01155726|OG007|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
11020735|NCT01155726|OG008|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
11020736|NCT01155726|OG009|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
11020737|NCT01155726|OG010|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
11020738|NCT01155726|OG011|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
11020739|NCT01155726|OG012|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
11020740|NCT01155726|OG013|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
11020741|NCT01155726|OG014|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
11020742|NCT01155726|OG015|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
11020743|NCT01155726|EG000|Reported Event|Nelfilcon A|Nelfilcon A contact lenses
11020744|NCT01155726|EG001|Reported Event|Etafilcon A|Etafilcon A contact lenses
11020745|NCT01155726|EG002|Reported Event|1DAVM|Etafilcon A with comfort additive contact lenses
11020746|NCT01155726|EG003|Reported Event|DACP|Nelfilcon A with comfort additive contact lenses
11020747|NCT01155778|BG000|Baseline|HGT-1410 10 mg|HGT-1410/rhHNS 10 mg monthly via an IDDD (every 28 [±7 days]) for a total of 6 months.
11020748|NCT01155778|BG001|Baseline|HGT-1410 45 mg|HGT-1410/rhHNS 45 mg monthly via an IDDD (every 28 [±7 days]) for a total of 6 months.
11020749|NCT01155778|BG002|Baseline|HGT-1410 90 mg|HGT-1410/rhHNS 45 mg dose every 14 [±2 days] for a monthly total dose of 90 mg via an IDDD for 6 months.
11020750|NCT01155778|BG003|Baseline|Total|Total of all reporting groups
11020751|NCT01155778|FG000|Participant Flow|HGT-1410 10 mg|HGT-1410/rhHNS 10 milligram (mg) monthly via an intrathecal drug delivery device (IDDD) (every 28 [±7 days]) for a total of 6 months.
11020752|NCT01155778|FG001|Participant Flow|HGT-1410 45 mg|HGT-1410/rhHNS 45 mg monthly via an IDDD (every 28 [±7 days]) for a total of 6 months.
11020753|NCT01155778|FG002|Participant Flow|HGT-1410 90 mg|HGT-1410/rhHNS 45 mg dose every 14 [±2 days] for a monthly total dose of 90 mg via an IDDD for 6 months.
11020754|NCT01155778|OG000|Outcome|HGT-1410 10 mg|HGT-1410/rhHNS 10 mg monthly via an IDDD (every 28 [±7 days]) for a total of 6 months.
11020755|NCT01155778|OG001|Outcome|HGT-1410 45 mg|HGT-1410/rhHNS 45 mg monthly via an IDDD (every 28 [±7 days]) for a total of 6 months.
11020756|NCT01155778|OG002|Outcome|HGT-1410 90 mg|HGT-1410/rhHNS 45 mg dose every 14 [±2 days] for a monthly total dose of 90 mg via an IDDD for 6 months.
11020757|NCT01155778|EG000|Reported Event|HGT-1410 10 mg|HGT-1410/rhHNS 10 mg monthly via an IDDD (every 28 [±7 days]) for a total of 6 months.
11020758|NCT01155778|EG001|Reported Event|HGT-1410 45 mg|HGT-1410/rhHNS 45 mg monthly via an IDDD (every 28 [±7 days]) for a total of 6 months.
11020759|NCT01155778|EG002|Reported Event|HGT-1410 90 mg|HGT-1410/rhHNS 45 mg dose every 14 [±2 days] for a monthly total dose of 90 mg via an IDDD for 6 months.
11020760|NCT01155830|BG000|Baseline|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
11020761|NCT01155830|BG001|Baseline|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
11020762|NCT01155830|BG002|Baseline|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
11020763|NCT01155830|BG003|Baseline|Total|Total of all reporting groups
11020764|NCT01155830|FG000|Participant Flow|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
11020765|NCT01155830|FG001|Participant Flow|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
11020766|NCT01155830|FG002|Participant Flow|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
11020767|NCT01155830|OG000|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
11020768|NCT01155830|OG001|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
11020769|NCT01155830|OG002|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
11020770|NCT01155830|EG000|Reported Event|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
11020771|NCT01155830|EG001|Reported Event|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
11020772|NCT01155830|EG002|Reported Event|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
11020773|NCT01155869|BG000|Baseline|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
11020774|NCT01155869|BG001|Baseline|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
11020775|NCT01155869|BG002|Baseline|Total|Total of all reporting groups
11020776|NCT01155869|FG000|Participant Flow|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
11020777|NCT01155869|FG001|Participant Flow|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
11020778|NCT01155869|OG000|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
11020779|NCT01155869|OG001|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
11020780|NCT01155869|EG000|Reported Event|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
11020781|NCT01155869|EG001|Reported Event|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
11020782|NCT01155999|BG000|Baseline|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
11020783|NCT01155999|BG001|Baseline|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
11020784|NCT01155999|BG002|Baseline|Total|Total of all reporting groups
11020785|NCT01155999|FG000|Participant Flow|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
11020786|NCT01155999|FG001|Participant Flow|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
11020787|NCT01155999|OG000|Outcome|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
11020788|NCT01155999|OG001|Outcome|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
11020789|NCT01155999|EG000|Reported Event|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
11020790|NCT01155999|EG001|Reported Event|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
11020791|NCT01156012|BG000|Baseline|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
11020792|NCT01156012|BG001|Baseline|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
11020793|NCT01156012|BG002|Baseline|Total|Total of all reporting groups
11020794|NCT01156012|FG000|Participant Flow|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm"
11020795|NCT01156012|FG001|Participant Flow|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
11020796|NCT01156012|OG000|Outcome|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
11020797|NCT01156012|OG001|Outcome|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
11020798|NCT01156012|EG000|Reported Event|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
11020799|NCT01156012|EG001|Reported Event|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
11020800|NCT01156051|BG000|Baseline|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets were started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
11020801|NCT01156051|BG001|Baseline|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg were started and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
11020802|NCT01156051|BG002|Baseline|Total|Total of all reporting groups
11020803|NCT01156051|FG000|Participant Flow|Treatment Group|Children who received (double blinded, randomized) guanfacine extended release tablets in a flexible dosing protocol, with doses ranging from 1mg to 4mg administered once daily in the morning.
11020804|NCT01156051|FG001|Participant Flow|Control|Children who received a matching placebo tablet administered once daily in the morning in a flexible dosing protocol, with tablets identical to guanfacine extended release from 1mg to 4mg.
11020805|NCT01156051|OG000|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
11020806|NCT01156051|OG001|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
11020807|NCT01156051|EG000|Reported Event|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
11020808|NCT01156051|EG001|Reported Event|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
11020809|NCT01156116|BG000|Baseline|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
11020810|NCT01156116|BG001|Baseline|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
11020811|NCT01156116|BG002|Baseline|Total|Total of all reporting groups
11020812|NCT01156116|FG000|Participant Flow|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
11020813|NCT01156116|FG001|Participant Flow|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
11020814|NCT01156116|OG000|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
11020815|NCT01156116|OG001|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
11020816|NCT01156116|EG000|Reported Event|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
11020817|NCT01156116|EG001|Reported Event|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
11020818|NCT01156142|BG000|Baseline|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
11020819|NCT01156142|BG001|Baseline|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
11020820|NCT01156142|BG002|Baseline|Total|Total of all reporting groups
10886279|NCT00493064|FG000|Participant Flow|Prospective Active Treatment|"Niacin 500mg TID PO for treatment of retinal vein occlusions.~Nicotinic acid: topical eye drops~Prednisolone acetate: topical eye drops"
10886280|NCT00493064|OG000|Outcome|Prospective Active Treatment|"Niacin 500mg TID PO for treatment of retinal vein occlusions.~Nicotinic acid: topical eye drops~Prednisolone acetate: topical eye drops"
10886281|NCT00493064|EG000|Reported Event|Prospective Active Treatment|"Niacin 500mg TID PO for treatment of retinal vein occlusions.~Nicotinic acid: topical eye drops~Prednisolone acetate: topical eye drops"
10886282|NCT00493181|BG000|Baseline|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
10886283|NCT00493181|FG000|Participant Flow|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
10886284|NCT00493181|OG000|Outcome|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
10886285|NCT00493181|EG000|Reported Event|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
10886286|NCT00493220|BG000|Baseline|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
10886287|NCT00493220|BG001|Baseline|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
10886288|NCT00493220|BG002|Baseline|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
10886289|NCT00493220|BG003|Baseline|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
10886290|NCT00493220|BG004|Baseline|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
10886291|NCT00493220|BG005|Baseline|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
10886292|NCT00493220|BG006|Baseline|Total|Total of all reporting groups
10886293|NCT00493220|FG000|Participant Flow|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
10886294|NCT00493220|FG001|Participant Flow|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
10886295|NCT00493220|FG002|Participant Flow|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
10886296|NCT00493220|FG003|Participant Flow|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
10886297|NCT00493220|FG004|Participant Flow|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
10886298|NCT00493220|FG005|Participant Flow|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
11148639|NCT01866098|FG002|Participant Flow|Naltrexone 50mg|"Oral Naltrexone 50mg capsule taken once daily for 52 weeks~Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study."
10886299|NCT00493220|OG000|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous hylenex and ceftriaxone
10886300|NCT00493220|OG001|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
10886301|NCT00493220|OG002|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
10886302|NCT00493220|OG000|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
10886303|NCT00493220|OG002|Outcome|Intravenous|All per-protocol participant administered intravenous ceftriaxone
10886304|NCT00493220|EG000|Reported Event|HYLENEX SC|All participants administered subcutaneous HYLENEX and ceftriaxone
10886305|NCT00493220|EG001|Reported Event|Placebo SC|All participants administered subcutaneous placebo and ceftriaxone
10886306|NCT00493220|EG002|Reported Event|Intravenous|All participants administered intravenous ceftriaxone
10886307|NCT00493246|BG000|Baseline|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
10886308|NCT00493246|BG001|Baseline|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
10886309|NCT00493246|BG002|Baseline|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886310|NCT00493246|BG003|Baseline|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886311|NCT00493246|BG004|Baseline|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886312|NCT00493246|BG005|Baseline|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886313|NCT00493246|BG006|Baseline|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
11020821|NCT01156142|FG000|Participant Flow|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
11020822|NCT01156142|FG001|Participant Flow|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
11020823|NCT01156142|OG000|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
11020824|NCT01156142|OG001|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
11020825|NCT01156142|EG000|Reported Event|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
11020826|NCT01156142|EG001|Reported Event|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
11020827|NCT01156311|BG000|Baseline|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
11020828|NCT01156311|BG001|Baseline|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
11020829|NCT01156311|BG002|Baseline|Total|Total of all reporting groups
11020830|NCT01156311|FG000|Participant Flow|Monotherapy Period: Interferon Beta (IFNß)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
11020831|NCT01156311|FG001|Participant Flow|Monotherapy Period: Glatiramer Acetate (GA)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
11020832|NCT01156311|FG002|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to IFNß|"BG00012 (dimethyl fumarate) was to be administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months) as an add-on to a stable dose of IFNß.~Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study."
11020833|NCT01156311|FG003|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to GA|"Dimethyl fumarate was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).~Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study."
11020834|NCT01156311|OG000|Outcome|Monotherapy Period: IFNß|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
11020835|NCT01156311|OG001|Outcome|Monotherapy Period: GA|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
11020836|NCT01156311|OG000|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
11020837|NCT01156311|OG001|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
11020838|NCT01156311|OG000|Outcome|Interferon Beta 1a (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
11020839|NCT01156311|EG000|Reported Event|Monotherapy Period: IFNß|A stable dose of one of the IFNß products for up to 8 weeks (until the first dose of BG00012).
11020840|NCT01156311|EG001|Reported Event|Monotherapy Period: GA|A stable dose of GA for up to 8 weeks (until the first dose of BG00012).
11020841|NCT01156311|EG002|Reported Event|Add-on Therapy Period: IFNß and BG00012|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
11148640|NCT01866098|OG000|Outcome|Placebo|"Oral placebo capsule taken once daily for 52 weeks~Placebo"
11148641|NCT01866098|OG001|Outcome|Naltrexone 25mg|"Oral Naltrexone 25mg capsule taken once daily for 52 weeks~Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study."
11020842|NCT01156311|EG003|Reported Event|Add-on Therapy Period: GA and BG00012|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
11020843|NCT01156363|BG000|Baseline|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
11020844|NCT01156363|FG000|Participant Flow|Mircera|"Participants received Mircera (epoetin beta-methoxy polyethylene glycol) 80, 120, 200, or 360 micrograms (mcg) (based on the weekly dose of erythropoiesis stimulating agent [ESA] participant received in the week preceding the switch to Mircera [Week -1]) by intravenous (IV) or subcutaneous (SC) injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on hemoglobin (Hb) level.~This arm includes participants enrolled at all 3 centers."
11020845|NCT01156363|OG000|Outcome|Mircera - CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at China Medical University Hospital (CMUH)."
11020846|NCT01156363|OG001|Outcome|Mircera - KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
11020847|NCT01156363|OG002|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
11020848|NCT01156363|OG003|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
11020849|NCT01156363|OG000|Outcome|Mircera - CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at CMUH."
11020850|NCT01156363|OG001|Outcome|Mircera - KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at KMUH."
11020851|NCT01156363|OG002|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at BTCH."
11020852|NCT01156363|OG000|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
11020853|NCT01156363|EG000|Reported Event|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
11020854|NCT01156376|BG000|Baseline|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
11020855|NCT01156376|BG001|Baseline|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
11020856|NCT01156376|BG002|Baseline|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
10849744|NCT00297882|FG000|Participant Flow|1 Artemether-Lumefantrine|"Drug: Artemether-Lumefantrine, Artemether-Lumefantrine(Co-Artem) =Artemether, 2mg/kg x 2 (12H apart)/Lumefantrine, 12mg/kgx2 (12H apart).~Other Names: • CoArtem,"
11020857|NCT01156376|BG003|Baseline|Total|Total of all reporting groups
11020858|NCT01156376|FG000|Participant Flow|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
11020859|NCT01156376|FG001|Participant Flow|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
11020860|NCT01156376|FG002|Participant Flow|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
11020861|NCT01156376|OG000|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
11020862|NCT01156376|OG001|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
11020863|NCT01156376|OG002|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
11020864|NCT01156376|EG000|Reported Event|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
11020865|NCT01156376|EG001|Reported Event|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
11020866|NCT01156376|EG002|Reported Event|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
11148642|NCT01866098|OG002|Outcome|Naltrexone 50mg|"Oral Naltrexone 50mg capsule taken once daily for 52 weeks~Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study."
11148643|NCT01866098|EG000|Reported Event|Placebo|"Oral placebo capsule taken once daily for 52 weeks~Placebo"
11148644|NCT01866098|EG001|Reported Event|Naltrexone 25mg|"Oral Naltrexone 25mg capsule taken once daily for 52 weeks~Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study."
11020867|NCT01156480|BG000|Baseline|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
11020868|NCT01156480|BG001|Baseline|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
10886314|NCT00493246|BG007|Baseline|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
11020869|NCT01156480|BG002|Baseline|Total|Total of all reporting groups
11148645|NCT01866098|EG002|Reported Event|Naltrexone 50mg|"Oral Naltrexone 50mg capsule taken once daily for 52 weeks~Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study."
11148646|NCT01866150|BG000|Baseline|Overall Population|Retrospective chart review of all participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to NICE guidelines. Biologic combination therapy included biologic drug therapy (any) plus MTX or biologic plus MTX plus any other and classical DMARDs.
11148647|NCT01866150|FG000|Participant Flow|Overall Population|Retrospective chart review of all participants with rheumatoid arthritis (RA) who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to National Institute for Health and Care Excellence (NICE) guidelines. Biologic combination therapy included biologic drug therapy (any) plus methotrexate (MTX) or biologic plus MTX plus any other and classical disease-modifying antirheumatic drugs (DMARDs).
11148648|NCT01866150|OG000|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
11148649|NCT01866150|OG001|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
11148650|NCT01866150|OG000|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
11148651|NCT01866150|EG000|Reported Event|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) as monotherapy according to NICE guidelines.
11148652|NCT01866150|EG001|Reported Event|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
11148653|NCT01866163|BG000|Baseline|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
11148654|NCT01866163|BG001|Baseline|Vehicle|Aerosol foam vehicle
11148655|NCT01866163|BG002|Baseline|Total|Total of all reporting groups
11148656|NCT01866163|FG000|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
11148657|NCT01866163|FG001|Participant Flow|Vehicle|Aerosol foam vehicle
11148658|NCT01866163|OG000|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
11148659|NCT01866163|OG001|Outcome|Vehicle|Aerosol foam vehicle
11148660|NCT01866163|EG000|Reported Event|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
11148661|NCT01866163|EG001|Reported Event|Vehicle|Aerosol foam vehicle
11148662|NCT01866293|BG000|Baseline|Cabozantinib (XL184)|"Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.~Cabozantinib (XL184)"
11148663|NCT01866293|FG000|Participant Flow|Cabozantinib (XL184)|"Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.~Cabozantinib (XL184)"
11148664|NCT01866293|OG000|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
11148665|NCT01866293|EG000|Reported Event|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
11148666|NCT01866306|BG000|Baseline|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148667|NCT01866306|BG001|Baseline|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11020870|NCT01156480|FG000|Participant Flow|Hydrocortisone|hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous route for 3 days, then 2mg/kg/day divided every 8 hours IV for 1 day, then 1.5mg/kg/day divided every 8 hours IV for 1 day, then 1mg/kg/day divided every 12 hours for 1 day, then 0.5mg/kg/day in single dose for one day. Placebo group will receive equal volume of placebo on the same schedule. The first dose of study drug will be given within 6 hours of NEC diagnosis, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
11020871|NCT01156480|FG001|Participant Flow|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
11020872|NCT01156480|OG000|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
11020873|NCT01156480|OG001|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
11020874|NCT01156480|OG000|Outcome|Hydrocortisone|"Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.~hydrocortisone: Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via IV route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/k"
11148668|NCT01866306|BG002|Baseline|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148669|NCT01866306|BG003|Baseline|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148670|NCT01866306|BG004|Baseline|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148671|NCT01866306|BG005|Baseline|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148672|NCT01866306|BG006|Baseline|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148673|NCT01866306|BG007|Baseline|Total|Total of all reporting groups
11148674|NCT01866306|FG000|Participant Flow|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148675|NCT01866306|FG001|Participant Flow|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148676|NCT01866306|FG002|Participant Flow|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148677|NCT01866306|FG003|Participant Flow|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148678|NCT01866306|FG004|Participant Flow|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148679|NCT01866306|FG005|Participant Flow|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148680|NCT01866306|FG006|Participant Flow|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148681|NCT01866306|OG000|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148682|NCT01866306|OG001|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148683|NCT01866306|OG002|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
10886315|NCT00493246|BG008|Baseline|Total|Total of all reporting groups
11020875|NCT01156480|OG001|Outcome|Placebo|"Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.~placebo: Subjects in placebo group will receive a volume of placebo equal to the hydrocortisone group, on the same dosing schedule, with doses given every 8 hours via IV route for 3 days, followed by placebo every 8 hours IV for 1 day, followed by placebo every 8 hours IV for 1 day, followed by placebo every 12 hours for 1 day, followed by placebo in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn."
11020876|NCT01156480|EG000|Reported Event|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
11020877|NCT01156480|EG001|Reported Event|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
11020878|NCT01156532|BG000|Baseline|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
11020879|NCT01156532|FG000|Participant Flow|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
11020880|NCT01156532|OG000|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
11020881|NCT01156532|EG000|Reported Event|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
11148684|NCT01866306|OG003|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148685|NCT01866306|OG004|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148686|NCT01866306|OG005|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148687|NCT01866306|OG006|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148688|NCT01866306|EG000|Reported Event|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148689|NCT01866306|EG001|Reported Event|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148690|NCT01866306|EG002|Reported Event|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148691|NCT01866306|EG003|Reported Event|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148692|NCT01866306|EG004|Reported Event|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148693|NCT01866306|EG005|Reported Event|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148694|NCT01866306|EG006|Reported Event|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
11148695|NCT01866319|BG000|Baseline|Ipilimumab|Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
11148696|NCT01866319|BG001|Baseline|Pembrolizumab Q2W|Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
11148697|NCT01866319|BG002|Baseline|Pembrolizumab Q3W|Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
11148698|NCT01866319|BG003|Baseline|Total|Total of all reporting groups
11020882|NCT01156571|BG000|Baseline|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.~Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
11020883|NCT01156571|BG001|Baseline|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.~Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
11020884|NCT01156571|BG002|Baseline|Total|Total of all reporting groups
11225736|NCT02370121|FG000|Participant Flow|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
11225737|NCT02370121|FG001|Participant Flow|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
11225738|NCT02370121|OG000|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
11225739|NCT02370121|OG001|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
11225740|NCT02370121|EG000|Reported Event|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
11225741|NCT02370121|EG001|Reported Event|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
11225742|NCT02370160|BG000|Baseline|DT2219ARL|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225743|NCT02370160|FG000|Participant Flow|DT2219ARL 60 µg/kg/Dose (Phase I)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225744|NCT02370160|FG001|Participant Flow|DT2219 80 µg/kg/Dose (Phase I)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225745|NCT02370160|FG002|Participant Flow|DT2219 60 µg/kg/Dose (Phase II)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225746|NCT02370160|OG000|Outcome|DT2219ARL 60 µg/kg/Dose (Phase I)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225747|NCT02370160|OG001|Outcome|DT2219 80 µg/kg/Dose (Phase I)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225748|NCT02370160|OG002|Outcome|DT2219 (Phase II)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225749|NCT02370160|OG000|Outcome|DT2219ARL|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225750|NCT02370160|OG002|Outcome|DT2219 60 µg/kg/Dose (Phase II)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11225751|NCT02370160|OG000|Outcome|DT2219ARL 60 µg/kg/Dose (Phase I)|A recombinant bispecific antibody-targeted toxin. DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
11225752|NCT02370160|OG001|Outcome|DT2219 80 µg/kg/Dose (Phase I)|A recombinant bispecific antibody-targeted toxin. DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
11020885|NCT01156571|FG000|Participant Flow|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.~Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
11020886|NCT01156571|FG001|Participant Flow|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.~Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
11020887|NCT01156571|OG000|Outcome|Cangrelor Treatment Arm|
11020888|NCT01156571|OG001|Outcome|Clopidogrel Treatment Arm|
11020889|NCT01156571|EG000|Reported Event|Cangrelor Treatment Arm|
11020890|NCT01156571|EG001|Reported Event|Clopidogrel Treatment Arm|
11020891|NCT01156597|BG000|Baseline|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
11020892|NCT01156597|BG001|Baseline|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
11020893|NCT01156597|BG002|Baseline|Total|Total of all reporting groups
11020894|NCT01156597|FG000|Participant Flow|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
11020895|NCT01156597|FG001|Participant Flow|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
11020896|NCT01156597|OG000|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
11020897|NCT01156597|OG001|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
11020898|NCT01156597|OG000|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
11020899|NCT01156597|EG000|Reported Event|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
11020900|NCT01156597|EG001|Reported Event|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
11020901|NCT01156675|BG000|Baseline|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
11020902|NCT01156675|BG001|Baseline|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer
11020903|NCT01156675|BG002|Baseline|No Treatment|Not treated with FLEXUS or X-STOP
11020904|NCT01156675|BG003|Baseline|Total|Total of all reporting groups
11020905|NCT01156675|FG000|Participant Flow|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
11020906|NCT01156675|FG001|Participant Flow|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
11020907|NCT01156675|FG002|Participant Flow|No Treatment|Not treated with FLEXUS or X-STOP
11020908|NCT01156675|OG000|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
11020909|NCT01156675|OG001|Outcome|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
11020910|NCT01156675|OG002|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
11020911|NCT01156675|OG001|Outcome|XSTOP® Interspinous Spacer|XSTOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
11020912|NCT01156675|EG000|Reported Event|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
11020913|NCT01156675|EG001|Reported Event|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer
11020914|NCT01156675|EG002|Reported Event|No Treatment|Not treated with FLEXUS or X-STOP
11020915|NCT01156701|BG000|Baseline|All Patients Included in the Analysis|All patients at least 5 years old enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009
11020916|NCT01156701|FG000|Participant Flow|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020917|NCT01156701|FG001|Participant Flow|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020918|NCT01156701|FG002|Participant Flow|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020919|NCT01156701|FG003|Participant Flow|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
11020920|NCT01156701|OG000|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020921|NCT01156701|OG001|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020922|NCT01156701|OG002|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020923|NCT01156701|OG003|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
11020924|NCT01156701|EG000|Reported Event|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020925|NCT01156701|EG001|Reported Event|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020926|NCT01156701|EG002|Reported Event|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
11020927|NCT01156701|EG003|Reported Event|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
11020928|NCT01156714|BG000|Baseline|Arm 1: Treadmill Training|"Treadmill training with aerobic exercise~treadmill training: walk on treadmill for aerobic exercise"
11020929|NCT01156714|BG001|Baseline|Arm 2: Memory Training|"Memory training with computerized memory program~computerized memory training: memory testing and training on computer program"
11020930|NCT01156714|BG002|Baseline|Arm 3: Treadmill and Memory Training|"Combination of treadmill training and computerized memory program~treadmill training: walk on treadmill for aerobic exercise~computerized memory training: memory testing and training on computer program"
11020931|NCT01156714|BG003|Baseline|Total|Total of all reporting groups
11020932|NCT01156714|FG000|Participant Flow|Arm 1: Treadmill Training|"Treadmill training with aerobic exercise~treadmill training: walk on treadmill for aerobic exercise"
11020933|NCT01156714|FG001|Participant Flow|Arm 2: Memory Training|"Memory training with computerized memory program~computerized memory training: memory testing and training on computer program"
11020934|NCT01156714|FG002|Participant Flow|Arm 3: Treadmill and Memory Training|"Combination of treadmill training and computerized memory program~treadmill training: walk on treadmill for aerobic exercise~computerized memory training: memory testing and training on computer program"
11020935|NCT01156714|OG000|Outcome|Arm 1: Treadmill Training|"Treadmill training with aerobic exercise~treadmill training: walk on treadmill for aerobic exercise"
11020936|NCT01156714|OG001|Outcome|Arm 2: Memory Training|"Memory training with computerized memory program~computerized memory training: memory testing and training on computer program"
11020937|NCT01156714|OG002|Outcome|Arm 3: Treadmill and Memory Training|"Combination of treadmill training and computerized memory program~treadmill training: walk on treadmill for aerobic exercise~computerized memory training: memory testing and training on computer program"
11020938|NCT01156714|OG000|Outcome|Arm 1: Treadmill Training|"Treadmill training with aerobic exercise~Treadmill training with aerobic exercise: walk on treadmill for aerobic exercise"
11020939|NCT01156714|OG001|Outcome|Arm 2: Memory Training|"Memory training with computerized memory program~Memory training with computerized memory program: memory testing and training on computer program"
11020940|NCT01156714|OG002|Outcome|Arm 3: Treadmill and Memory Training|"Combination of treadmill training and computerized memory program~Combination of treadmill training and computerized memory: both exercise and cognitive computer training"
11020941|NCT01156714|EG000|Reported Event|Arm 1: Treadmill Training|"Treadmill training with aerobic exercise~treadmill training: walk on treadmill for aerobic exercise"
11020942|NCT01156714|EG001|Reported Event|Arm 2: Memory Training|"Memory training with computerized memory program~computerized memory training: memory testing and training on computer program"
11020943|NCT01156714|EG002|Reported Event|Arm 3: Treadmill and Memory Training|"Combination of treadmill training and computerized memory program~treadmill training: walk on treadmill for aerobic exercise~computerized memory training: memory testing and training on computer program"
11020944|NCT01156792|BG000|Baseline|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
11020945|NCT01156792|FG000|Participant Flow|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
11020946|NCT01156792|OG000|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
11020947|NCT01156792|OG001|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
11020948|NCT01156792|OG002|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
11020949|NCT01156792|OG003|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
11020950|NCT01156792|OG004|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
11020951|NCT01156792|OG000|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
11020952|NCT01156792|OG001|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
11020953|NCT01156792|OG002|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
11020954|NCT01156792|EG000|Reported Event|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
11020955|NCT01156792|EG001|Reported Event|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
11020956|NCT01156792|EG002|Reported Event|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
11020957|NCT01156792|EG003|Reported Event|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
11020958|NCT01156792|EG004|Reported Event|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
11020959|NCT01156805|BG000|Baseline|Educational Intervention, Control|"Experimental, intervention group has received educational training to improve food habits and physical activity~Educational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ"
11020960|NCT01156805|BG001|Baseline|Non Intervention|No intervention has been made.
11020961|NCT01156805|BG002|Baseline|Total|Total of all reporting groups
11020962|NCT01156805|FG000|Participant Flow|Educational Intervention, Control|"Experimental, intervention group has received educational training to improve food habits and physical activity~Educational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test"
11020963|NCT01156805|FG001|Participant Flow|Non Intervention|No intervention has been made.
11066202|NCT01391000|FG001|Participant Flow|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
11020964|NCT01156805|OG000|Outcome|Educational Intervention, Control|"Experimental, intervention group has received educational training to improve food habits and physical activity~Educational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test"
11020965|NCT01156805|OG001|Outcome|Non Intervention|No intervention has been made.
11020966|NCT01156805|EG000|Reported Event|Educational Intervention, Control|No untoward or unfavorable medical occurrence in a participants. There's no medication
11020967|NCT01156805|EG001|Reported Event|Non Intervention|No intervention has been made.
11020968|NCT01156844|BG000|Baseline|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020969|NCT01156844|BG001|Baseline|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020970|NCT01156844|BG002|Baseline|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020971|NCT01156844|BG003|Baseline|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020972|NCT01156844|BG004|Baseline|Total|Total of all reporting groups
11020973|NCT01156844|FG000|Participant Flow|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020974|NCT01156844|FG001|Participant Flow|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020975|NCT01156844|FG002|Participant Flow|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020976|NCT01156844|FG003|Participant Flow|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020977|NCT01156844|OG000|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11066203|NCT01391000|OG000|Outcome|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
11148699|NCT01866319|FG000|Participant Flow|Ipilimumab|Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
11148700|NCT01866319|FG001|Participant Flow|Pembrolizumab Q2W|Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
10849745|NCT00297882|FG001|Participant Flow|2 Amodiaquine- Artesunate|Drug: Amodiaquine-Artesunate Amodiaquine-Artemether - administration D0 (0H), D1 (24H), D2 (48H)- Artesunate 4mg/kg & Amodiaquine at 10mg/kg Other Names: • Arsucam
11148701|NCT01866319|FG002|Participant Flow|Pembrolizumab Q3W|Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
11020978|NCT01156844|OG001|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020979|NCT01156844|OG002|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020980|NCT01156844|OG003|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020981|NCT01156844|OG002|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
11020982|NCT01156844|OG000|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020983|NCT01156844|OG001|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020984|NCT01156844|EG000|Reported Event|Indacaterol 37.5 ug (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020985|NCT01156844|EG001|Reported Event|Indacaterol 75 ug (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020986|NCT01156844|EG002|Reported Event|Indacaterol 150 ug (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020987|NCT01156844|EG003|Reported Event|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11020988|NCT01156987|BG000|Baseline|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
11148702|NCT01866319|OG000|Outcome|Ipilimumab|Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
11148703|NCT01866319|OG001|Outcome|Pembrolizumab Q2W|Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
11020989|NCT01156987|BG001|Baseline|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
11020990|NCT01156987|BG002|Baseline|Total|Total of all reporting groups
11020991|NCT01156987|FG000|Participant Flow|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
11020992|NCT01156987|FG001|Participant Flow|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained. 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
11020993|NCT01156987|OG000|Outcome|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
11020994|NCT01156987|OG001|Outcome|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
11020995|NCT01156987|EG000|Reported Event|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
11020996|NCT01156987|EG001|Reported Event|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
11020997|NCT01157065|BG000|Baseline|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
11020998|NCT01157065|BG001|Baseline|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
11020999|NCT01157065|BG002|Baseline|Total|Total of all reporting groups
11021000|NCT01157065|FG000|Participant Flow|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
11021001|NCT01157065|FG001|Participant Flow|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
11021002|NCT01157065|OG000|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
11021003|NCT01157065|OG001|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
11021004|NCT01157065|EG000|Reported Event|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
11021005|NCT01157065|EG001|Reported Event|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
11021006|NCT01157078|BG000|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11021007|NCT01157078|BG001|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11021008|NCT01157078|BG002|Baseline|Total|Total of all reporting groups
11021009|NCT01157078|FG000|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11021010|NCT01157078|FG001|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11021011|NCT01157078|OG000|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11021012|NCT01157078|OG001|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11021013|NCT01157078|EG000|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11021014|NCT01157078|EG001|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11021015|NCT01157117|BG000|Baseline|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
11021016|NCT01157117|BG001|Baseline|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
11021017|NCT01157117|BG002|Baseline|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
11021018|NCT01157117|BG003|Baseline|Total|Total of all reporting groups
11021019|NCT01157117|FG000|Participant Flow|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
11021020|NCT01157117|FG001|Participant Flow|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
11021021|NCT01157117|FG002|Participant Flow|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
11021022|NCT01157117|OG000|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
11021023|NCT01157117|OG001|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
11021024|NCT01157117|OG002|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
11021025|NCT01157117|EG000|Reported Event|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
11021026|NCT01157117|EG001|Reported Event|Placebo for Omalizumab/Milk OIT|Placebo for omalizumab: Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the omalizumab treatment group (determined by the participant's IgE level and weight).
11021027|NCT01157117|EG002|Reported Event|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
11021028|NCT01157169|BG000|Baseline|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
11021029|NCT01157169|BG001|Baseline|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
11021030|NCT01157169|BG002|Baseline|Total|Total of all reporting groups
11021031|NCT01157169|FG000|Participant Flow|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
11021032|NCT01157169|FG001|Participant Flow|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
11021033|NCT01157169|OG000|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
11021034|NCT01157169|OG001|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
11021035|NCT01157169|EG000|Reported Event|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
11021036|NCT01157169|EG001|Reported Event|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
11021037|NCT01157182|BG000|Baseline|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
11021038|NCT01157182|BG001|Baseline|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
11021039|NCT01157182|BG002|Baseline|Total|Total of all reporting groups
11021040|NCT01157182|FG000|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
11021041|NCT01157182|FG001|Participant Flow|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
11021042|NCT01157182|OG000|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
11021043|NCT01157182|OG001|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
11021044|NCT01157182|EG000|Reported Event|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
11021045|NCT01157182|EG001|Reported Event|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
11021046|NCT01157234|BG000|Baseline|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021047|NCT01157234|BG001|Baseline|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021048|NCT01157234|BG002|Baseline|Total|Total of all reporting groups
11021049|NCT01157234|FG000|Participant Flow|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021050|NCT01157234|FG001|Participant Flow|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021051|NCT01157234|OG000|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021052|NCT01157234|OG001|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021053|NCT01157234|OG000|Outcome|Nebivolol <50 Year Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
11225753|NCT02370160|OG002|Outcome|DT2219 60 µg/kg/Dose (Phase II)|A recombinant bispecific antibody-targeted toxin. DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
11021054|NCT01157234|OG001|Outcome|Metoprolol >/= 50 Year Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
11021055|NCT01157234|OG000|Outcome|Nebivolol < 50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021056|NCT01157234|OG001|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021057|NCT01157234|OG000|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021058|NCT01157234|OG001|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients age less than 50 years treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021059|NCT01157234|OG001|Outcome|Metoprolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
11021060|NCT01157234|EG000|Reported Event|Nebivolol|"Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.~Nebivolol: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90."
11021061|NCT01157234|EG001|Reported Event|Metoprolol|"Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.~Metoprolol: Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90."
11021062|NCT01157351|BG000|Baseline|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
11021063|NCT01157351|BG001|Baseline|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
11021064|NCT01157351|BG002|Baseline|Total|Total of all reporting groups
11021065|NCT01157351|FG000|Participant Flow|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
11021066|NCT01157351|FG001|Participant Flow|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
11021067|NCT01157351|OG000|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
11021068|NCT01157351|OG001|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
11021069|NCT01157351|EG000|Reported Event|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
11021070|NCT01157351|EG001|Reported Event|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
11021071|NCT01157364|BG000|Baseline|Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021072|NCT01157364|BG001|Baseline|Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021073|NCT01157364|BG002|Baseline|Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021074|NCT01157364|BG003|Baseline|Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021075|NCT01157364|BG004|Baseline|Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021076|NCT01157364|BG005|Baseline|Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021077|NCT01157364|BG006|Baseline|Total|Total of all reporting groups
11021078|NCT01157364|FG000|Participant Flow|Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021079|NCT01157364|FG001|Participant Flow|Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021080|NCT01157364|FG002|Participant Flow|Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021081|NCT01157364|FG003|Participant Flow|Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021082|NCT01157364|FG004|Participant Flow|Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021083|NCT01157364|FG005|Participant Flow|Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021084|NCT01157364|OG000|Outcome|Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021085|NCT01157364|OG001|Outcome|Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021086|NCT01157364|OG002|Outcome|Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021087|NCT01157364|OG003|Outcome|Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021088|NCT01157364|OG004|Outcome|Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021089|NCT01157364|OG005|Outcome|Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021090|NCT01157364|EG000|Reported Event|Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021091|NCT01157364|EG001|Reported Event|Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021092|NCT01157364|EG002|Reported Event|Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021093|NCT01157364|EG003|Reported Event|Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021094|NCT01157364|EG004|Reported Event|Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021095|NCT01157364|EG005|Reported Event|Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%|Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
11021096|NCT01157377|BG000|Baseline|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
11021097|NCT01157377|BG001|Baseline|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
11021098|NCT01157377|BG002|Baseline|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
11021099|NCT01157377|BG003|Baseline|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
11021100|NCT01157377|BG004|Baseline|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
11021101|NCT01157377|BG005|Baseline|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
11021102|NCT01157377|BG006|Baseline|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
11021103|NCT01157377|BG007|Baseline|Total|Total of all reporting groups
11021104|NCT01157377|FG000|Participant Flow|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
11021105|NCT01157377|FG001|Participant Flow|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
11021106|NCT01157377|FG002|Participant Flow|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
11021107|NCT01157377|FG003|Participant Flow|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
11021108|NCT01157377|FG004|Participant Flow|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
11021109|NCT01157377|FG005|Participant Flow|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
11021110|NCT01157377|FG006|Participant Flow|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
11021111|NCT01157377|OG000|Outcome|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
11021112|NCT01157377|OG001|Outcome|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
11021113|NCT01157377|OG002|Outcome|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
11021114|NCT01157377|OG003|Outcome|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
11021115|NCT01157377|OG004|Outcome|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
11021116|NCT01157377|OG005|Outcome|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
11021117|NCT01157377|OG006|Outcome|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
11021118|NCT01157377|EG000|Reported Event|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
11021119|NCT01157377|EG001|Reported Event|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
11021120|NCT01157377|EG002|Reported Event|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
11021121|NCT01157377|EG003|Reported Event|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
11021122|NCT01157377|EG004|Reported Event|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
11021123|NCT01157377|EG005|Reported Event|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
11021124|NCT01157377|EG006|Reported Event|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
11021125|NCT01157416|BG000|Baseline|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021126|NCT01157416|BG001|Baseline|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021127|NCT01157416|BG002|Baseline|Total|Total of all reporting groups
11021128|NCT01157416|FG000|Participant Flow|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021129|NCT01157416|FG001|Participant Flow|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021130|NCT01157416|OG000|Outcome|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021131|NCT01157416|OG001|Outcome|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021132|NCT01157416|EG000|Reported Event|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021133|NCT01157416|EG001|Reported Event|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021134|NCT01157429|BG000|Baseline|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021135|NCT01157429|BG001|Baseline|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021136|NCT01157429|BG002|Baseline|Total|Total of all reporting groups
11021137|NCT01157429|FG000|Participant Flow|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021138|NCT01157429|FG001|Participant Flow|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021139|NCT01157429|OG000|Outcome|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021140|NCT01157429|OG001|Outcome|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol."
11021141|NCT01157429|EG000|Reported Event|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
11021142|NCT01157429|EG001|Reported Event|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol."
11021143|NCT01157676|BG000|Baseline|Open Cystectomy|Standard of care treatment, open cystectomy
11021144|NCT01157676|BG001|Baseline|Robotic Assisted Radical Cystectomy|Standard of care treatment, robotic assisted radical cystectomy
11021145|NCT01157676|BG002|Baseline|Total|Total of all reporting groups
11021146|NCT01157676|FG000|Participant Flow|Open Radical Cystectomy|Standard of care treatment
11021147|NCT01157676|FG001|Participant Flow|Robotic Assisted Radical Cystectomy|Standard of care treatment using DaVinci robot
11021148|NCT01157676|OG000|Outcome|Open Radical Cystectomy|Standard of care treatment
11021149|NCT01157676|OG001|Outcome|Robotic Assisted Radical Cystectomy|Standard of care treatment using the DaVinci robot.
11021150|NCT01157676|OG000|Outcome|Open Radical Cystectomy|Standard of care treatment, open cystectomy
11021151|NCT01157676|OG001|Outcome|Robotic Assisted Radical Cystectomy|Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot
11021152|NCT01157676|OG001|Outcome|Robotic Assisted Radical Cystectomy|Standard of care treatment, robotic assisted radical cystectomy using DaVinci robot
11021153|NCT01157676|OG000|Outcome|Open Cystectomy|"Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.~Open radical cystectomy: Standard of care removal of urinary bladder."
11021154|NCT01157676|OG001|Outcome|Robotic Assisted Radical Cystectomy|"Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.~Robotic assisted radical cystectomy: Standard of care removal of urinary bladder using DaVinci robot.~DaVinci robot: DaVinci robotic surgical system."
11021155|NCT01157676|OG001|Outcome|Robotic Assisted Radical Cystectomy|Standard of care treatment using DaVinci robot
11021156|NCT01157676|EG000|Reported Event|Open Cystectomy|Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.
11021157|NCT01157676|EG001|Reported Event|Robotic Assisted Radical Cystectomy|Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.
11021158|NCT01157845|BG000|Baseline|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
11021159|NCT01157845|FG000|Participant Flow|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
11021160|NCT01157845|OG000|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
11021161|NCT01157845|EG000|Reported Event|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
11021162|NCT01157897|BG000|Baseline|Cohort 1: 15 μg VMP001|"15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021163|NCT01157897|BG001|Baseline|Cohort 2: 30 μg VMP001|"30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021164|NCT01157897|BG002|Baseline|Cohort 3: 60 μg VMP001|"60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021165|NCT01157897|BG003|Baseline|Control|"No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021166|NCT01157897|BG004|Baseline|Total|Total of all reporting groups
11021167|NCT01157897|FG000|Participant Flow|Cohort 1: 15 μg VMP001|"15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GlaxoSmithKline (GSK) Biologicals' Adjuvant System AS01B (Adjuvant Formulation)~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021168|NCT01157897|FG001|Participant Flow|Cohort 2: 30 μg VMP001|"30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021169|NCT01157897|FG002|Participant Flow|Cohort 3: 60 μg VMP001|"60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021170|NCT01157897|FG003|Participant Flow|Control|"No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021171|NCT01157897|OG000|Outcome|Cohort 1: 15 μg VMP001|"15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021172|NCT01157897|OG001|Outcome|Cohort 2: 30 μg VMP001|"30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021173|NCT01157897|OG002|Outcome|Cohort 3: 60 μg VMP001|"60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.~VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021174|NCT01157897|OG003|Outcome|Control|"No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.~P. vivax sporozoite challenge: P. vivax sporozoite challenge"
11021175|NCT01157897|EG000|Reported Event|Cohort 1: 15 μg VMP001|01
11021176|NCT01157897|EG001|Reported Event|Cohort 2: 30 μg VMP001|02
11021177|NCT01157897|EG002|Reported Event|Cohort 3: 60 μg VMP001|03
11021178|NCT01157897|EG003|Reported Event|Cohort 4: Control|04
11021179|NCT01158118|BG000|Baseline|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
11021180|NCT01158118|BG001|Baseline|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
11021181|NCT01158118|BG002|Baseline|Total|Total of all reporting groups
11021182|NCT01158118|FG000|Participant Flow|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
11021183|NCT01158118|FG001|Participant Flow|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
11021184|NCT01158118|OG000|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
11021185|NCT01158118|OG000|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
11021186|NCT01158118|EG000|Reported Event|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
11021187|NCT01158118|EG001|Reported Event|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
11021188|NCT01158157|BG000|Baseline|Vaccination|"This study was a single arm study. All eligible subjects received ACAM2000.~ACAM2000: Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle."
11021189|NCT01158157|FG000|Participant Flow|Vaccination|"This study was a single arm study. All eligible subjects received ACAM2000.~ACAM2000: Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle."
11021190|NCT01158157|OG000|Outcome|ACAM200 Vaccination Dose|Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0.
11021191|NCT01158157|EG000|Reported Event|ACAM200 Vaccination Dose|Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0.
11021192|NCT01158222|BG000|Baseline|Arm I|"Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given orally~laboratory biomarker analysis: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~polymorphism analysis: Correlative studies"
11021193|NCT01158222|FG000|Participant Flow|Arm I|"Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given orally~laboratory biomarker analysis: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~polymorphism analysis: Correlative studies"
11021194|NCT01158222|OG000|Outcome|Arm I|"Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given orally~laboratory biomarker analysis: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~polymorphism analysis: Correlative studies"
11021195|NCT01158222|EG000|Reported Event|Arm I|"Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given orally~laboratory biomarker analysis: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~polymorphism analysis: Correlative studies"
11148704|NCT01866319|OG002|Outcome|Pembrolizumab Q3W|Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
11148705|NCT01866319|EG000|Reported Event|Ipilimumab|Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
10849746|NCT00297882|OG000|Outcome|1 Artemether-Lumefantrine AL|1Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
11021196|NCT01158261|BG000|Baseline|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon's standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
11021197|NCT01158261|FG000|Participant Flow|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon's standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
11021198|NCT01158261|OG000|Outcome|EVICEL® Fibrin Sealant (Human)|
11021199|NCT01158261|EG000|Reported Event|EVICEL® Fibrin Sealant (Human)|"An adverse event (AE) was defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of the EVICEL® product. For the purpose of this protocol, an AE was any untoward medical occurrence in a study subject that may be related or possibly related to the EVICEL® product. The relatedness to EVICEL® was based on the investigator's assessment.~In the original version of the protocol, the SAE definition did not require that the AE be related or possibly related to the treatment. This discrepancy with the AE definition resulted in the sites reporting non-EVICEL® related AEs and SAEs prior to the amended protocol implementation."
11021200|NCT01158378|BG000|Baseline|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
11021201|NCT01158378|BG001|Baseline|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
11021202|NCT01158378|BG002|Baseline|Total|Total of all reporting groups
11021203|NCT01158378|FG000|Participant Flow|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
11021204|NCT01158378|FG001|Participant Flow|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
11021205|NCT01158378|OG000|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
11021206|NCT01158378|OG001|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
11225754|NCT02370160|EG000|Reported Event|DT2219ARL 60 µg/kg/Dose (Phase I)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11021207|NCT01158378|OG000|Outcome|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
11021208|NCT01158378|EG000|Reported Event|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
10849747|NCT00297882|OG001|Outcome|2 Amodiaquine-Artesunate AQ-AS|2 Amodiaquine-Artesunate 4mg/kg and Amodiaquine at 10mg/kg
11021209|NCT01158378|EG001|Reported Event|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
11066204|NCT01391000|OG001|Outcome|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
11066205|NCT01391000|EG000|Reported Event|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
11066206|NCT01391000|EG001|Reported Event|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
11066207|NCT01391013|BG000|Baseline|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
11066208|NCT01391013|BG001|Baseline|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
11066209|NCT01391013|BG002|Baseline|Total|Total of all reporting groups
11066210|NCT01391013|FG000|Participant Flow|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
11066211|NCT01391013|FG001|Participant Flow|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
11066212|NCT01391013|OG000|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
11066213|NCT01391013|OG001|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
11066214|NCT01391013|EG000|Reported Event|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
11066215|NCT01391013|EG001|Reported Event|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
11066216|NCT01391130|BG000|Baseline|LY2510924 + Sunitinib|LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
11066217|NCT01391130|BG001|Baseline|Sunitinib|50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
11021210|NCT01158404|BG000|Baseline|2 mg LY900009 - Dose Escalation Phase (Part A)|2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021211|NCT01158404|BG001|Baseline|4 mg LY900009 - Dose Escalation Phase (Part A)|4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021212|NCT01158404|BG002|Baseline|8 mg LY900009 - Dose Escalation Phase (Part A)|8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021213|NCT01158404|BG003|Baseline|15 mg LY900009 - Dose Escalation Phase (Part A)|15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021214|NCT01158404|BG004|Baseline|30 mg LY900009 - Dose Escalation Phase (Part A)|30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021215|NCT01158404|BG005|Baseline|45 mg LY900009 - Dose Escalation Phase (Part A)|45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021216|NCT01158404|BG006|Baseline|60 mg LY900009 - Dose Escalation Phase (Part A)|60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021217|NCT01158404|BG007|Baseline|30 mg LY900009 - Dose Confirmation Phase (Part B)|30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle
11021218|NCT01158404|BG008|Baseline|Total|Total of all reporting groups
11021219|NCT01158404|FG000|Participant Flow|2 mg LY900009 - Dose Escalation Phase (Part A)|2 milligram (mg) LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021220|NCT01158404|FG001|Participant Flow|4 mg LY900009 - Dose Escalation Phase (Part A)|4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021221|NCT01158404|FG002|Participant Flow|8 mg LY900009 - Dose Escalation Phase (Part A)|8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11225755|NCT02370160|EG001|Reported Event|DT2219 80 µg/kg/Dose (Phase I)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11021222|NCT01158404|FG003|Participant Flow|15 mg LY900009 - Dose Escalation Phase (Part A)|15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021223|NCT01158404|FG004|Participant Flow|30 mg LY900009 - Dose Escalation Phase (Part A)|30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021224|NCT01158404|FG005|Participant Flow|45 mg LY900009 - Dose Escalation Phase (Part A)|45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021225|NCT01158404|FG006|Participant Flow|60 mg LY900009 - Dose Escalation Phase (Part A)|60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021226|NCT01158404|FG007|Participant Flow|30 mg LY900009 - Dose Confirmation Phase (Part B)|30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021227|NCT01158404|OG000|Outcome|2 mg LY900009 - Dose Escalation Phase (Part A)|2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021228|NCT01158404|OG001|Outcome|4 mg LY900009 - Dose Escalation Phase (Part A)|4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021229|NCT01158404|OG002|Outcome|8 mg LY900009 - Dose Escalation Phase (Part A)|8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021230|NCT01158404|OG003|Outcome|15 mg LY900009 - Dose Escalation Phase (Part A)|15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021231|NCT01158404|OG004|Outcome|30 mg LY900009 - Dose Escalation Phase (Part A)|30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021232|NCT01158404|OG005|Outcome|45 mg LY900009 - Dose Escalation Phase (Part A)|45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021233|NCT01158404|OG006|Outcome|60 mg LY900009 - Part A: Dose Escalation|60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021234|NCT01158404|OG007|Outcome|30 mg LY900009 - Dose Confirmation Phase (Part B)|30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021235|NCT01158404|OG000|Outcome|LY900009 - Dose Escalation Phase (Part A)|2 mg, 4 mg, 8 mg, 15mg, 30 mg, 45 mg and 60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021236|NCT01158404|OG006|Outcome|60 mg LY900009 - Dose Escalation Phase (Part A)|60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021237|NCT01158404|OG004|Outcome|30 mg LY900009 - Dose Escalation/Confirmation Phase (Part A,B)|30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021238|NCT01158404|EG000|Reported Event|2 mg LY900009 - Dose Escalation Phase (Part A)|2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021239|NCT01158404|EG001|Reported Event|4 mg LY900009 - Dose Escalation Phase (Part A)|4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021240|NCT01158404|EG002|Reported Event|8 mg LY900009 - Dose Escalation Phase (Part A)|8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021241|NCT01158404|EG003|Reported Event|15 mg LY900009 - Dose Escalation Phase (Part A)|15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021242|NCT01158404|EG004|Reported Event|30 mg LY900009 - Dose Escalation/Confirmation Phase (Part A,B)|30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021243|NCT01158404|EG005|Reported Event|45 mg LY900009 - Dose Escalation Phase (Part A)|45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021244|NCT01158404|EG006|Reported Event|60 mg LY900009 - Dose Escalation Phase (Part A)|60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
11021245|NCT01158521|BG000|Baseline|Treatment Group|"Patients receive oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.~pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity.~therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride."
11021246|NCT01158521|FG000|Participant Flow|Treatment Group|"Patients receive oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.~pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity.~therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride."
11021247|NCT01158521|OG000|Outcome|Arm I|"Patients receive oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.~pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity.~therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride."
11021248|NCT01158521|OG000|Outcome|Treatment Group|"Patients receive oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.~pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity.~therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride."
11021249|NCT01158521|OG000|Outcome|Treatment Group|"Patients receive oral pazopanib hydrochloride once daily for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.~pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 18 weeks in the absence of disease progression or unacceptable toxicity.~therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride."
11021250|NCT01158521|EG000|Reported Event|Treatment Group|"Patients receive oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.~pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity.~therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride."
11021251|NCT01158534|BG000|Baseline|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11021252|NCT01158534|FG000|Participant Flow|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11021253|NCT01158534|OG000|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11021254|NCT01158534|EG000|Reported Event|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11021255|NCT01158573|BG000|Baseline|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
11021256|NCT01158573|BG001|Baseline|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
11021257|NCT01158573|BG002|Baseline|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
11021258|NCT01158573|BG003|Baseline|Non Asthma Obese (NAO)|BMI > 30 Obese
11021259|NCT01158573|BG004|Baseline|Total|Total of all reporting groups
11021260|NCT01158573|FG000|Participant Flow|Obese Asthma|"Obese Asthma (OA)~BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
11021261|NCT01158573|FG001|Participant Flow|Non Asthma, Non-obese|BMI 20-25 Non obese
11021262|NCT01158573|FG002|Participant Flow|Asthma, Non-obese|BMI 20-25 Non obese
11021263|NCT01158573|FG003|Participant Flow|Non Asthma, Obese|BMI .30
11021264|NCT01158573|OG000|Outcome|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
11021265|NCT01158573|OG001|Outcome|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
11021266|NCT01158573|OG002|Outcome|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
11021267|NCT01158573|OG003|Outcome|Non Asthma Obese (NAO)|BMI > 30 Obese
11021268|NCT01158573|EG000|Reported Event|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
11021269|NCT01158573|EG001|Reported Event|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
11066218|NCT01391130|BG002|Baseline|Total|Total of all reporting groups
11021270|NCT01158573|EG002|Reported Event|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
11021271|NCT01158573|EG003|Reported Event|Non Asthma Obese (NAO)|BMI > 30 Obese
11021272|NCT01158651|BG000|Baseline|Active Therapy|"If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks). You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection. If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks)."
11021273|NCT01158651|FG000|Participant Flow|RAD001 (Everolimus) Active Therapy|"If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks).~You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection.~RAD001 (Everolimus): If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 course"
11021274|NCT01158651|OG000|Outcome|RAD001 (Everolimus) Active Therapy|"If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks). You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection. If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks)."
11021275|NCT01158651|EG000|Reported Event|RAD001 (Everolimus) Active Therapy|"If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks). You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection. If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks)."
11021276|NCT01158703|BG000|Baseline|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
11021277|NCT01158703|BG001|Baseline|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
11021278|NCT01158703|BG002|Baseline|Total|Total of all reporting groups
11021279|NCT01158703|FG000|Participant Flow|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
11021280|NCT01158703|FG001|Participant Flow|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
10849748|NCT00297882|OG000|Outcome|1 Artemether-Lumefantrine|1Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
11021281|NCT01158703|OG000|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
11021282|NCT01158703|OG001|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
11021283|NCT01158703|EG000|Reported Event|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
11021284|NCT01158703|EG001|Reported Event|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
11021285|NCT01158716|BG000|Baseline|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
11021286|NCT01158716|BG001|Baseline|Control|
11021287|NCT01158716|BG002|Baseline|Total|Total of all reporting groups
11021288|NCT01158716|FG000|Participant Flow|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
11021289|NCT01158716|FG001|Participant Flow|Control|
11021290|NCT01158716|OG000|Outcome|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
11021291|NCT01158716|OG001|Outcome|Control|
11021292|NCT01158716|EG000|Reported Event|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
11021293|NCT01158716|EG001|Reported Event|Control|
11021294|NCT01158820|BG000|Baseline|Placebo|Placebo + Standard of Care of midazolam and fentanyl
11021295|NCT01158820|BG001|Baseline|Dexmedetomidine and Ketamine|dexmedetomidine and ketamine + Standard of Care of midazolam and fentanyl
11021296|NCT01158820|BG002|Baseline|Total|Total of all reporting groups
11021297|NCT01158820|FG000|Participant Flow|Placebo|"Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes.~Following nebulization, syringe A (placebo) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time.~After step 2, syringe B (midazolam 2 mg and fentanyl 50 µg) will be administered by the anesthesiologist. The infusion rate of syringe A (placebo) will be decreased to 0.7 µg/kg/hr. Syringe C (placebo) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration)~Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl.~placebo + Standard of Care of midazolam and fentanyl: Control Saline 50 ml Midazolam 2 mg + Fentanyl 50 µg Saline 20 ml Midazolam 1"
11021298|NCT01158820|FG001|Participant Flow|Dexmedetomidine and Ketamine|"Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes.~Following nebulization, syringe A (dexmedetomidine) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time.~After step 2, syringe B (ketamine 30 mg) will be administered by the anesthesiologist. The infusion rate of syringe A (dexmedetomidine) will be decreased to 0.7 µg/kg/hr. Syringe C (ketamine) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration)~Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl.~dexmedetomidine and ketamine Study Medication: Experimental Dexmedetomidine 200 µg in 50 ml Ketamine 30 mg Ketamine 200 mg in 20 ml M"
11021299|NCT01158820|OG000|Outcome|Placebo|Placebo + Standard of Care of midazolam and fentanyl
11021300|NCT01158820|OG001|Outcome|Dexmedetomidine and Ketamine|dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
11021301|NCT01158820|OG001|Outcome|Dexmedetomidine and Ketamine|dexmedetomidine and ketamine + Standard of Care (midazolam + fentanyl)
11021302|NCT01158820|EG000|Reported Event|Placebo|Placebo + Standard of Care (midazolam and fentanyl)
11021303|NCT01158820|EG001|Reported Event|Dexmedetomidine and Ketamine|dexmedetomidine and ketamine + Standard of Care (midazolam + fentanyl)
11021304|NCT01158885|BG000|Baseline|Single Arm|"Clofarabine, Cytarabine, Methotrexate~See detailed description in Interventions section."
11021305|NCT01158885|FG000|Participant Flow|Single Arm|"Clofarabine, Cytarabine, Methotrexate~See detailed description in Interventions section."
11021306|NCT01158885|OG000|Outcome|Single Arm|"Clofarabine, Cytarabine, Methotrexate~See detailed description in Interventions section."
11021307|NCT01158885|EG000|Reported Event|Single Arm|"Clofarabine, Cytarabine, Methotrexate~See detailed description in Interventions section."
11021308|NCT01158924|BG000|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11021309|NCT01158924|BG001|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11021310|NCT01158924|BG002|Baseline|Total|Total of all reporting groups
11021311|NCT01158924|FG000|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11021312|NCT01158924|FG001|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11021313|NCT01158924|OG000|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11021314|NCT01158924|OG001|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11021315|NCT01158924|EG000|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11021316|NCT01158924|EG001|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11021317|NCT01158950|BG000|Baseline|All Study Participants|All study participants receiving either Tolcapone 200mg (single dose) or Placebo (single dose) administered at study visit, followed by crossover to other drug at next visit - all participants were randomized to receive all interventions.
11148706|NCT01866319|EG001|Reported Event|Pembrolizumab Q2W|Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
11021318|NCT01158950|FG000|Participant Flow|Tolcapone First, Then Placebo|Tolcapone 200mg (single dose) then Placebo (single dose) administered at study visit, followed by crossover to other drug at next visit
11021319|NCT01158950|FG001|Participant Flow|Placebo First, Then Tolcapone|Placebo (single dose) then Tolcapone 200mg (single dose) tadministered at study visit, followed by crossover to other drug at next visit
11021320|NCT01158950|OG000|Outcome|Functional MRI Arm (Tolcapone and Placebo)|This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion. Tolcapone is a medication in the class of catechol-O-methyltransferase (COMT) inhibitors. A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients.
11021321|NCT01158950|EG000|Reported Event|Tolcapone|Tolcapone 200mg (single dose)
11021322|NCT01158950|EG001|Reported Event|Placebo|Placebo (single dose)
11021323|NCT01158976|BG000|Baseline|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
11021324|NCT01158976|BG001|Baseline|Soybean Oil|Placebo: soybean oils with strawberry flavoring
11021325|NCT01158976|BG002|Baseline|Total|Total of all reporting groups
11021326|NCT01158976|FG000|Participant Flow|DHA Supplementation|Docosahexanoic Acid (DHA): 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
11021327|NCT01158976|FG001|Participant Flow|Soybean Oil|Placebo: soybean oils with strawberry flavoring
11021328|NCT01158976|OG000|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
11021329|NCT01158976|OG001|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
11021330|NCT01158976|EG000|Reported Event|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
11021331|NCT01158976|EG001|Reported Event|Soybean Oil|Placebo: soybean oils with strawberry flavoring
11021332|NCT01159015|BG000|Baseline|KetoNaph|"KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05%~KetoNaph: Ophthalmic Solution administered BID for 6 weeks"
11021333|NCT01159015|BG001|Baseline|Vehicle|"Vehicle of KetoNaph Ophthalmic Solution~Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks"
11021334|NCT01159015|BG002|Baseline|Total|Total of all reporting groups
11225756|NCT02370160|EG002|Reported Event|DT2219 (Phase II)|"A recombinant bispecific antibody-targeted toxin.~DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity."
11021335|NCT01159015|FG000|Participant Flow|KetoNaph|"KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05%~KetoNaph: Ophthalmic Solution administered BID for 6 weeks"
11021336|NCT01159015|FG001|Participant Flow|Vehicle|"Vehicle of KetoNaph Ophthalmic Solution~Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks"
11021337|NCT01159015|OG000|Outcome|KetoNaph|"KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05%~KetoNaph: Ophthalmic Solution administered BID for 6 weeks"
11021338|NCT01159015|OG001|Outcome|Vehicle|"Vehicle of KetoNaph Ophthalmic Solution~Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks"
11021339|NCT01159015|EG000|Reported Event|KetoNaph|"KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05%~KetoNaph: Ophthalmic Solution administered BID for 6 weeks"
11021340|NCT01159015|EG001|Reported Event|Vehicle|"Vehicle of KetoNaph Ophthalmic Solution~Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks"
11021341|NCT01159054|BG000|Baseline|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
11021342|NCT01159054|FG000|Participant Flow|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
11021343|NCT01159054|OG000|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
11021344|NCT01159054|EG000|Reported Event|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
11341293|NCT03680521|OG001|Outcome|Sitravatinib 80 mg|Participants received sitravatinib orally, once a day, at a dose of 80 mg for 2 weeks (segment 1). Then, the participants continued to receive sitravatinib in combination with nivolumab 240 mg administered as an intravenous (IV) infusion every 2 weeks, for a maximum of 6 additional weeks (segment 2).
11021345|NCT01159067|BG000|Baseline|Arm I|Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
11021346|NCT01159067|FG000|Participant Flow|Arm I|Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
11021347|NCT01159067|OG000|Outcome|Arm I|Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
11021348|NCT01159067|EG000|Reported Event|Arm I|Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
11021349|NCT01159171|BG000|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
11021350|NCT01159171|FG000|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
11021351|NCT01159171|OG000|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
11021352|NCT01159171|OG000|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Cycle 1 (28-Day Cycle) Participants received 5 milligrams/kilograms (mg/kg) bevacizumab intravenously (IV) on Days 1 and 15; 40 mg/meter^2 (mg/m^2) oxaliplatin IV on Days 1, 8, 15, and 22; and 2000 mg/m^2 capecitabine orally (PO) in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14 followed by a rest period on Days 15 through 28. Cycle 1 was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
11021353|NCT01159171|EG000|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
11021354|NCT01159262|BG000|Baseline|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021355|NCT01159262|BG001|Baseline|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021356|NCT01159262|BG002|Baseline|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021357|NCT01159262|BG003|Baseline|Total|Total of all reporting groups
11021358|NCT01159262|FG000|Participant Flow|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021359|NCT01159262|FG001|Participant Flow|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021360|NCT01159262|FG002|Participant Flow|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021361|NCT01159262|OG000|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
10849749|NCT00297882|OG001|Outcome|2 Amodiaquine-Artesunate|2 Amodiaquine-Artesunate 4mg/kg and Amodiaquine at 10mg/kg every day for 3 days
11021362|NCT01159262|OG001|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021363|NCT01159262|OG002|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021364|NCT01159262|EG000|Reported Event|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021365|NCT01159262|EG001|Reported Event|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021366|NCT01159262|EG002|Reported Event|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
11021367|NCT01159431|BG000|Baseline|Active|Trigeminal Nerve Stimulation-High Settings
11021368|NCT01159431|BG001|Baseline|Control|Trigeminal Nerve Stimulation-Low Settings
11021369|NCT01159431|BG002|Baseline|Total|Total of all reporting groups
11021370|NCT01159431|FG000|Participant Flow|Active|Trigeminal Nerve Stimulation-High Settings
11021371|NCT01159431|FG001|Participant Flow|Control|Trigeminal Nerve Stimulation-Low Settings
11021372|NCT01159431|OG000|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
11021373|NCT01159431|OG001|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
11021374|NCT01159431|OG000|Outcome|Control Group-Baseline|Baseline
11021375|NCT01159431|OG001|Outcome|Control Group-Double Blind Period|Sham Treatment
11021376|NCT01159431|OG002|Outcome|Treatment Group-Baseline|
11021377|NCT01159431|OG003|Outcome|Treatment Group-Double Blind Period|
11021378|NCT01159431|OG000|Outcome|Treatment|
11021379|NCT01159431|OG001|Outcome|Control|
11021380|NCT01159431|OG000|Outcome|Active|Trigeminal Nerve Stimulation-High Settings
11021381|NCT01159431|EG000|Reported Event|Active|Trigeminal Nerve Stimulation-High Settings
11021382|NCT01159431|EG001|Reported Event|Control|Trigeminal Nerve Stimulation-Low Settings
11021383|NCT01159535|BG000|Baseline|Mindfulness Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
11021384|NCT01159535|BG001|Baseline|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
11021385|NCT01159535|BG002|Baseline|Treatment as Usual|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.~Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
11021386|NCT01159535|BG003|Baseline|Total|Total of all reporting groups
11021387|NCT01159535|FG000|Participant Flow|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention~Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
11021388|NCT01159535|FG001|Participant Flow|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
11021389|NCT01159535|FG002|Participant Flow|Treatment as Usual (TAU)|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.~Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
11021390|NCT01159535|OG000|Outcome|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention~Mindfulness Based Relapse Prevention: The MBRP intervention consisted of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
11021391|NCT01159535|OG001|Outcome|Relapse Prevention (RP)|The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
11021392|NCT01159535|OG002|Outcome|Treatment as Usual (TAU)|Treatment as Usual included continuing care services (including attendance at Alcoholics Anonymous, Narcotics Anonymous, or other self-help groups) as recommended by their treatment providers.
11021393|NCT01159535|EG000|Reported Event|Mindfulness-Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
11021394|NCT01159535|EG001|Reported Event|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions were team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
11021395|NCT01159535|EG002|Reported Event|Treatment as Usual (TAU)|Treatment as Usual participants were enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants received ongoing support and monitoring by their continuing care providers on a regular basis.
11021396|NCT01159574|BG000|Baseline|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
11021397|NCT01159574|FG000|Participant Flow|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
11021398|NCT01159574|OG000|Outcome|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
11021399|NCT01159574|EG000|Reported Event|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
11021400|NCT01159600|BG000|Baseline|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
11021401|NCT01159600|BG001|Baseline|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021402|NCT01159600|BG002|Baseline|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021403|NCT01159600|BG003|Baseline|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021404|NCT01159600|BG004|Baseline|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021405|NCT01159600|BG005|Baseline|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021406|NCT01159600|BG006|Baseline|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021407|NCT01159600|BG007|Baseline|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021408|NCT01159600|BG008|Baseline|Total|Total of all reporting groups
11021409|NCT01159600|FG000|Participant Flow|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
11225757|NCT02370238|BG000|Baseline|Paclitaxel+Reparixin (Group 1) - Safety Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
11225758|NCT02370238|BG001|Baseline|Paclitaxel+Placebo (Group 2) - Safety Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
11225759|NCT02370238|BG002|Baseline|Total|Total of all reporting groups
11021410|NCT01159600|FG001|Participant Flow|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021411|NCT01159600|FG002|Participant Flow|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021412|NCT01159600|FG003|Participant Flow|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021413|NCT01159600|FG004|Participant Flow|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021414|NCT01159600|FG005|Participant Flow|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021415|NCT01159600|FG006|Participant Flow|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021416|NCT01159600|FG007|Participant Flow|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021417|NCT01159600|OG000|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
11021418|NCT01159600|OG001|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021419|NCT01159600|OG002|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021420|NCT01159600|OG003|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021421|NCT01159600|OG004|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021422|NCT01159600|OG005|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021423|NCT01159600|OG006|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021424|NCT01159600|OG007|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021425|NCT01159600|OG000|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks, in patients with background medication of metformin only.
11021426|NCT01159600|EG000|Reported Event|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
11021427|NCT01159600|EG001|Reported Event|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021428|NCT01159600|EG002|Reported Event|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021429|NCT01159600|EG003|Reported Event|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
11021430|NCT01159600|EG004|Reported Event|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021431|NCT01159600|EG005|Reported Event|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021432|NCT01159600|EG006|Reported Event|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11021433|NCT01159600|EG007|Reported Event|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
11225760|NCT02370238|FG000|Participant Flow|Paclitaxel+Reparixin (Group 1)|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
11021434|NCT01159665|BG000|Baseline|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
11021435|NCT01159665|BG001|Baseline|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
11021436|NCT01159665|BG002|Baseline|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
11021437|NCT01159665|BG003|Baseline|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
11021438|NCT01159665|BG004|Baseline|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
11021439|NCT01159665|BG005|Baseline|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
11021440|NCT01159665|BG006|Baseline|Total|Total of all reporting groups
11021441|NCT01159665|FG000|Participant Flow|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
11021442|NCT01159665|FG001|Participant Flow|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
11021443|NCT01159665|FG002|Participant Flow|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
11021444|NCT01159665|FG003|Participant Flow|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
11021445|NCT01159665|FG004|Participant Flow|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
11021446|NCT01159665|FG005|Participant Flow|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
11021447|NCT01159665|OG000|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
11021448|NCT01159665|OG001|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
11021449|NCT01159665|OG002|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
11021450|NCT01159665|OG003|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
11021451|NCT01159665|OG004|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
11021452|NCT01159665|OG005|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
11021453|NCT01159665|EG000|Reported Event|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
11021454|NCT01159665|EG001|Reported Event|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
11021455|NCT01159665|EG002|Reported Event|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
11021456|NCT01159665|EG003|Reported Event|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
11021457|NCT01159665|EG004|Reported Event|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
11021458|NCT01159665|EG005|Reported Event|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
11021459|NCT01159691|BG000|Baseline|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
11021460|NCT01159691|FG000|Participant Flow|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
11021461|NCT01159691|OG000|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
11021462|NCT01159691|EG000|Reported Event|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
11021463|NCT01159743|BG000|Baseline|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
11021464|NCT01159743|BG001|Baseline|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
11021465|NCT01159743|BG002|Baseline|Total|Total of all reporting groups
11021466|NCT01159743|FG000|Participant Flow|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
11021467|NCT01159743|FG001|Participant Flow|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
11021468|NCT01159743|OG000|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
11021469|NCT01159743|OG001|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
11021470|NCT01159743|EG000|Reported Event|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
11021471|NCT01159743|EG001|Reported Event|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
11021472|NCT01159769|BG000|Baseline|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
11021473|NCT01159769|FG000|Participant Flow|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
11021474|NCT01159769|OG000|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
11021475|NCT01159769|EG000|Reported Event|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
11021476|NCT01159912|BG000|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021477|NCT01159912|BG001|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021478|NCT01159912|BG002|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021479|NCT01159912|BG003|Baseline|Total|Total of all reporting groups
11021480|NCT01159912|FG000|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021481|NCT01159912|FG001|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021482|NCT01159912|FG002|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021483|NCT01159912|OG000|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11148707|NCT01866319|EG002|Reported Event|Pembrolizumab Q3W|Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
11021484|NCT01159912|OG001|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021485|NCT01159912|OG002|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021486|NCT01159912|EG000|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021487|NCT01159912|EG001|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021488|NCT01159912|EG002|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11021489|NCT01159938|BG000|Baseline|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
11021490|NCT01159938|BG001|Baseline|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021491|NCT01159938|BG002|Baseline|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021492|NCT01159938|BG003|Baseline|Total|Total of all reporting groups
11021493|NCT01159938|FG000|Participant Flow|Healthy Participants|Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
11021494|NCT01159938|FG001|Participant Flow|T2DM With Albuminuria, High to Low|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021495|NCT01159938|FG002|Participant Flow|T2DM With Albuminuria, Low to High|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021496|NCT01159938|FG003|Participant Flow|T2DM With Normal UAER, High to Low|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021497|NCT01159938|FG004|Participant Flow|T2DM With Normal UAER, Low to High|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021498|NCT01159938|OG000|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
11341294|NCT03680521|OG000|Outcome|PK Population: Sitravatinib 120 mg|PK assessments were assessed based on the actual dose associated with the visit. The PK assessment was associated with a daily dose of 120 mg of sitravatinib orally.
11021499|NCT01159938|OG001|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021500|NCT01159938|OG002|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
11021501|NCT01159938|OG003|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021502|NCT01159938|OG004|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
11021503|NCT01159938|OG005|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021504|NCT01159938|OG001|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021505|NCT01159938|OG003|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021506|NCT01159938|OG005|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021507|NCT01159938|OG000|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
11021508|NCT01159938|OG001|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
11021509|NCT01159938|OG002|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021510|NCT01159938|OG003|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
11021511|NCT01159938|OG004|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021512|NCT01159938|OG004|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose
11021513|NCT01159938|OG000|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams albumin per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
11021514|NCT01159938|EG000|Reported Event|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
11341295|NCT03680521|OG001|Outcome|PK Population: Sitravatinib 80 mg|PK assessments were assessed based on the actual dose associated with the visit. The PK assessment was associated with a daily dose of 80 mg of sitravatinib orally.
11021515|NCT01159938|EG001|Reported Event|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria(defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021516|NCT01159938|EG002|Reported Event|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
11021517|NCT01160198|BG000|Baseline|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
11021518|NCT01160198|BG001|Baseline|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
11021519|NCT01160198|BG002|Baseline|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
11021520|NCT01160198|BG003|Baseline|Total|Total of all reporting groups
11021521|NCT01160198|FG000|Participant Flow|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
11021522|NCT01160198|FG001|Participant Flow|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
11021523|NCT01160198|FG002|Participant Flow|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
11021524|NCT01160198|OG000|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
11021525|NCT01160198|OG001|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
11021526|NCT01160198|OG002|Outcome|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
10849750|NCT00297882|EG000|Reported Event|1 Artemether-Lumefantine (AL)|Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days.
11021527|NCT01160198|EG000|Reported Event|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
11021528|NCT01160198|EG001|Reported Event|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
11021529|NCT01160198|EG002|Reported Event|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
11021544|NCT01160237|BG000|Baseline|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
11021545|NCT01160237|BG001|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
11021546|NCT01160237|BG002|Baseline|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
11021547|NCT01160237|BG003|Baseline|Total|Total of all reporting groups
11021548|NCT01160237|FG000|Participant Flow|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
11021549|NCT01160237|FG001|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
11021550|NCT01160237|FG002|Participant Flow|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
11021551|NCT01160237|OG000|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
11021552|NCT01160237|OG001|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
11021553|NCT01160237|OG002|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
11021554|NCT01160237|EG000|Reported Event|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
11021555|NCT01160237|EG001|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
11021556|NCT01160237|EG002|Reported Event|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
11021557|NCT01160289|BG000|Baseline|1 mg LY2452473 and 5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 1-mg capsule~tadalafil 5-mg tablet~placebo 10-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021558|NCT01160289|BG001|Baseline|5 mg LY2452473 and 5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 5-mg capsule~tadalafil 5-mg tablet~placebo 10-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021559|NCT01160289|BG002|Baseline|5 mg LY2452473|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 5-mg capsule~placebo 5-mg tablet (matching tadalafil)~placebo 10-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021560|NCT01160289|BG003|Baseline|10 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~tadalafil 10-mg tablet~placebo 5-mg capsule (matching LY2452473)~placebo 5-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021561|NCT01160289|BG004|Baseline|5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~tadalafil 5-mg tablet~placebo 5-mg capsule (matching LY2452473)~placebo 10-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021562|NCT01160289|BG005|Baseline|Total|Total of all reporting groups
11021563|NCT01160289|FG000|Participant Flow|All Screened Subjects|After screening but prior to randomization, subjects completed a 4-week washout and a 4-week tadalafil [5-milligram (mg) tablet, administered orally, once daily] lead-in period.
11021564|NCT01160289|FG001|Participant Flow|1 mg LY2452473 and 5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 1-mg capsule~tadalafil 5-mg tablet~placebo 10-mg tablet (matching tadalafil)"
11021565|NCT01160289|FG002|Participant Flow|5 mg LY2452473 and 5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 5-mg capsule~tadalafil 5-mg tablet~placebo 10-mg tablet (matching tadalafil)"
11021566|NCT01160289|FG003|Participant Flow|5 mg LY2452473|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 5-mg capsule~placebo 5-mg tablet (matching tadalafil)~placebo 10-mg tablet (matching tadalafil)"
11021567|NCT01160289|FG004|Participant Flow|10 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~tadalafil 10-mg tablet~placebo 5-mg capsule (matching LY2452473)~placebo 5-mg tablet (matching tadalafil)"
11021568|NCT01160289|FG005|Participant Flow|5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~tadalafil 5-mg tablet~placebo 5-mg capsule (matching LY2452473)~placebo 10-mg tablet (matching tadalafil)"
11021569|NCT01160289|OG000|Outcome|1 mg LY2452473 and 5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 1-mg capsule~tadalafil 5-mg tablet~placebo 10-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021570|NCT01160289|OG001|Outcome|5 mg LY2452473 and 5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 5-mg capsule~tadalafil 5-mg tablet~placebo 10-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021571|NCT01160289|OG002|Outcome|5 mg LY2452473|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 5-mg capsule~placebo 5-mg tablet (matching tadalafil)~placebo 10-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021572|NCT01160289|OG003|Outcome|10 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~tadalafil 10-mg tablet~placebo 5-mg capsule (matching LY2452473)~placebo 5-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021573|NCT01160289|OG004|Outcome|5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~tadalafil 5-mg tablet~placebo 5-mg capsule (matching LY2452473)~placebo 10-mg tablet (matching tadalafil)~Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period."
11021574|NCT01160289|EG000|Reported Event|5 mg Tadalafil, Lead-in Period|5-mg tadalafil tablet, administered orally, once daily, during the 4-week lead-in period.
11021575|NCT01160289|EG001|Reported Event|1 mg LY2452473 and 5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 1-mg capsule~tadalafil 5-mg tablet~placebo 10-mg tablet (matching tadalafil)"
11021576|NCT01160289|EG002|Reported Event|5 mg LY2452473 and 5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 5-mg capsule~tadalafil 5-mg tablet~placebo 10-mg tablet (matching tadalafil)"
10849751|NCT00297882|EG001|Reported Event|2 Amodiaquine-Artesunate (AQ-AS)|Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days.
11021577|NCT01160289|EG003|Reported Event|5 mg LY2452473|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~LY2452473 5-mg capsule~placebo 5-mg tablet (matching tadalafil)~placebo 10-mg tablet (matching tadalafil)"
11021578|NCT01160289|EG004|Reported Event|10 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~tadalafil 10-mg tablet~placebo 5-mg capsule (matching LY2452473)~placebo 5-mg tablet (matching tadalafil)"
11021579|NCT01160289|EG005|Reported Event|5 mg Tadalafil|"The following study drugs, administered orally, once daily for 12 weeks post-randomization:~tadalafil 5-mg tablet~placebo 5-mg capsule (matching LY2452473)~placebo 10-mg tablet (matching tadalafil)"
11021580|NCT01160354|BG000|Baseline|Plerixafor 240 mcg/kg + Clofarabine|Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021581|NCT01160354|BG001|Baseline|Plerixafor 320 mcg/kg + Clofarabine|Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021582|NCT01160354|BG002|Baseline|Plerixafor 400 mcg/kg + Clofarabine|Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021583|NCT01160354|BG003|Baseline|Total|Total of all reporting groups
11021584|NCT01160354|FG000|Participant Flow|Plerixafor 240 mcg/kg + Clofarabine|Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour intravenous (IV) administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021585|NCT01160354|FG001|Participant Flow|Plerixafor 320 mcg/kg + Clofarabine|Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021586|NCT01160354|FG002|Participant Flow|Plerixafor 400 mcg/kg + Clofarabine|Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021587|NCT01160354|OG000|Outcome|Plerixafor 240 mcg/kg + Clofarabine|Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021588|NCT01160354|OG001|Outcome|Plerixafor 320 mcg/kg + Clofarabine|Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021589|NCT01160354|OG002|Outcome|Plerixafor 400 mcg/kg + Clofarabine|Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021590|NCT01160354|EG000|Reported Event|Plerixafor 240 mcg/kg + Clofarabine|Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021591|NCT01160354|EG001|Reported Event|Plerixafor 320 mcg/kg + Clofarabine|Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021592|NCT01160354|EG002|Reported Event|Plerixafor 400 mcg/kg + Clofarabine|Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
11021593|NCT01160380|BG000|Baseline|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets."
11021594|NCT01160380|BG001|Baseline|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.~Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets."
11021595|NCT01160380|BG002|Baseline|Total|Total of all reporting groups
11021596|NCT01160380|FG000|Participant Flow|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
11021597|NCT01160380|FG001|Participant Flow|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
11021598|NCT01160380|OG000|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
11021599|NCT01160380|OG001|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
11021600|NCT01160380|EG000|Reported Event|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs)."
11021601|NCT01160380|EG001|Reported Event|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.~AEs presented were those occurring during from Day 1 to Day 28 only"
11021602|NCT01160445|BG000|Baseline|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
11341296|NCT03680521|OG002|Outcome|PK Population: Sitravatinib 60 mg|PK assessments were assessed based on the actual dose associated with the visit. The PK assessment was associated with a daily dose of 60 mg of sitravatinib orally.
10849752|NCT00298038|BG000|Baseline|Rifaximin|Participants were administered a single rifaximin 550 mg tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
11021603|NCT01160445|BG001|Baseline|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
11021604|NCT01160445|BG002|Baseline|Total|Total of all reporting groups
11021605|NCT01160445|FG000|Participant Flow|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
11021606|NCT01160445|FG001|Participant Flow|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
11021607|NCT01160445|OG000|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
11021608|NCT01160445|OG001|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
11021609|NCT01160445|EG000|Reported Event|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
11021610|NCT01160445|EG001|Reported Event|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
11021611|NCT01160458|BG000|Baseline|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
11021612|NCT01160458|FG000|Participant Flow|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
11021613|NCT01160458|OG000|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
11021614|NCT01160458|EG000|Reported Event|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
11021615|NCT01160484|BG000|Baseline|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:~Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:~1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
11021616|NCT01160484|FG000|Participant Flow|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin (PLD)+ Lenalidomide (DVD-R) Therapy:~Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:~1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
11021617|NCT01160484|OG000|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
11021618|NCT01160484|EG000|Reported Event|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
11021619|NCT01160614|BG000|Baseline|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
11021620|NCT01160614|BG001|Baseline|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
11021621|NCT01160614|BG002|Baseline|Total|Total of all reporting groups
11021622|NCT01160614|FG000|Participant Flow|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
11021623|NCT01160614|FG001|Participant Flow|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
11021624|NCT01160614|OG000|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
11021625|NCT01160614|OG001|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
11021626|NCT01160614|OG002|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
11021627|NCT01160614|OG003|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
11225761|NCT02370238|FG001|Participant Flow|Paclitaxel+Placebo (Group 2)|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
11225762|NCT02370238|OG000|Outcome|Paclitaxel+Reparixin (Group 1) - ITT Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
10886316|NCT00493246|FG000|Participant Flow|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
10886317|NCT00493246|FG001|Participant Flow|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
10886318|NCT00493246|FG002|Participant Flow|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886319|NCT00493246|FG003|Participant Flow|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886320|NCT00493246|FG004|Participant Flow|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886321|NCT00493246|FG005|Participant Flow|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886322|NCT00493246|FG006|Participant Flow|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886323|NCT00493246|FG007|Participant Flow|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886324|NCT00493246|OG000|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
10886325|NCT00493246|OG001|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
10886326|NCT00493246|OG002|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
11021628|NCT01160614|OG004|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
10886327|NCT00493246|OG003|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886328|NCT00493246|OG004|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886329|NCT00493246|OG005|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886330|NCT00493246|OG006|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886331|NCT00493246|OG007|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886332|NCT00493246|EG000|Reported Event|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
10886333|NCT00493246|EG001|Reported Event|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
10886334|NCT00493246|EG002|Reported Event|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886335|NCT00493246|EG003|Reported Event|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886336|NCT00493246|EG004|Reported Event|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
11021629|NCT01160614|OG005|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
11021630|NCT01160614|OG000|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received multiple doses of 10 mg ORF
11021631|NCT01160614|OG001|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received multiple doses of 15 mg ORF
11021632|NCT01160614|OG002|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received multiple doses of 20 mg ORF
11021633|NCT01160614|OG003|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 10 mg ORF
11021634|NCT01160614|OG004|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 15 mg ORF
11021635|NCT01160614|OG005|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
11021636|NCT01160614|OG000|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
11021637|NCT01160614|OG001|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
11021638|NCT01160614|OG002|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
11021639|NCT01160614|OG003|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
11021640|NCT01160614|OG004|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
11021641|NCT01160614|OG005|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
11021642|NCT01160614|OG000|Outcome|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
11021643|NCT01160614|OG001|Outcome|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
11021644|NCT01160614|EG000|Reported Event|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
11021645|NCT01160614|EG001|Reported Event|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
11021646|NCT01160640|BG000|Baseline|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
11021647|NCT01160640|BG001|Baseline|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
11021648|NCT01160640|BG002|Baseline|Total|Total of all reporting groups
11021649|NCT01160640|FG000|Participant Flow|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
11021650|NCT01160640|FG001|Participant Flow|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
11021651|NCT01160640|OG000|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
11021652|NCT01160640|OG001|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
11021653|NCT01160640|OG000|Outcome|Histological Endometritis Present|Women who had endometritis confirmed by histologic assessment for endometritis. Endometritis was defined as >1 plasma cell per 100X microscopic field, was assessed independently by 2 pathologists blinded to the design
11021654|NCT01160640|OG001|Outcome|Histological Endometritis Absent|Women who did not have endometritis confirmed by histologic assessment for endometritis
11021655|NCT01160640|EG000|Reported Event|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
11021656|NCT01160640|EG001|Reported Event|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
11021657|NCT01160744|BG000|Baseline|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021658|NCT01160744|BG001|Baseline|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021659|NCT01160744|BG002|Baseline|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021660|NCT01160744|BG003|Baseline|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021661|NCT01160744|BG004|Baseline|Total|Total of all reporting groups
11021662|NCT01160744|FG000|Participant Flow|Pem + Carb or Cis (Non-Squamous)|"Pemetrexed (Pem): 500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle.~Carboplatin (Carb) [Area Under the Concentration Time Curve 6 (AUC 6)] : Day 1 of every 21-day cycle.~Cisplatin (Cis): 75 mg/m² intravenous (IV) on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
11021663|NCT01160744|FG001|Participant Flow|Ram + Pem + Carb or Cis (Non-Squamous)|Ramucirumab (Ram): 10 milligrams/kilogram (mg/kg) Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021664|NCT01160744|FG002|Participant Flow|Gem + Carb or Cis (Squamous)|"Gemcitabine (Gem): 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb [Area Under the Concentration Time Curve 5 (AUC 5)]: Day 1 of every 21-day cycle.~Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
11021665|NCT01160744|FG003|Participant Flow|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of each every 21-day cycle. Participants were treated for up to 89 weeks.
11021666|NCT01160744|OG000|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021667|NCT01160744|OG001|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021668|NCT01160744|OG002|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021669|NCT01160744|OG003|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021670|NCT01160744|OG001|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
11021671|NCT01160744|OG003|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021672|NCT01160744|EG000|Reported Event|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021673|NCT01160744|EG001|Reported Event|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021674|NCT01160744|EG002|Reported Event|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021675|NCT01160744|EG003|Reported Event|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
11021676|NCT01160770|BG000|Baseline|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
11021677|NCT01160770|FG000|Participant Flow|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
11021678|NCT01160770|OG000|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
11021679|NCT01160770|EG000|Reported Event|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
11021680|NCT01160822|BG000|Baseline|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
11021681|NCT01160822|BG001|Baseline|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
11021682|NCT01160822|BG002|Baseline|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
11021683|NCT01160822|BG003|Baseline|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
11021684|NCT01160822|BG004|Baseline|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021685|NCT01160822|BG005|Baseline|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021686|NCT01160822|BG006|Baseline|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
11021687|NCT01160822|BG007|Baseline|Total|Total of all reporting groups
11021688|NCT01160822|FG000|Participant Flow|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
11021689|NCT01160822|FG001|Participant Flow|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
11021690|NCT01160822|FG002|Participant Flow|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
11021691|NCT01160822|FG003|Participant Flow|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
11021692|NCT01160822|FG004|Participant Flow|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021693|NCT01160822|FG005|Participant Flow|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021694|NCT01160822|FG006|Participant Flow|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
11021695|NCT01160822|OG000|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
11021696|NCT01160822|OG001|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
11021697|NCT01160822|OG002|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
11021698|NCT01160822|OG003|Outcome|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
11021699|NCT01160822|OG000|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021700|NCT01160822|OG001|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021701|NCT01160822|OG002|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
11021702|NCT01160822|OG003|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021703|NCT01160822|EG000|Reported Event|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
11021704|NCT01160822|EG001|Reported Event|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
11021705|NCT01160822|EG002|Reported Event|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
11021706|NCT01160822|EG003|Reported Event|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
11021707|NCT01160822|EG004|Reported Event|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021708|NCT01160822|EG005|Reported Event|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
11021709|NCT01160822|EG006|Reported Event|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
11021710|NCT01160848|BG000|Baseline|3 Areas Per Patient, 3 Hours|
11021711|NCT01160848|BG001|Baseline|3 Areas Per Patient, 24 Hours|
11021712|NCT01160848|BG002|Baseline|Total|Total of all reporting groups
11021713|NCT01160848|FG000|Participant Flow|3 Areas Per Patient, 3 Hours|Visonac : MAL 80 mg/g Group 1: Alcohol wipe and Visonac without occlusion Group 2: Saline wipe and Visonac with occlusion Group 3: Saline wipe and Visonac without occlusion
11021714|NCT01160848|FG001|Participant Flow|3 Areas Per Patient, 24 Hours|Group 1: Visonac left on skin for 1 hour Group 2: Visonac left on skin for 24 hours, area 1 Group 3: Visonac left on skin for 24 hours, area 2
11021715|NCT01160848|OG000|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
11021716|NCT01160848|OG001|Outcome|Area Cleaned With Saline|
11021717|NCT01160848|OG002|Outcome|Area Cleaned With Ethyl Alcohol Solution|
11021718|NCT01160848|OG000|Outcome|Visonac Wiped Off After 1 Hour|
11021719|NCT01160848|OG001|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
11021720|NCT01160848|OG002|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
11021721|NCT01160848|EG000|Reported Event|3 Areas Per Patient, 3 Hours|
11021722|NCT01160848|EG001|Reported Event|3 Areas Per Patient, 24 Hours|
11021723|NCT01161043|BG000|Baseline|Subjects Wearing Sensors|"All subjects that wear sensors (all subjects)~Sensor wear: All subjects to wear sensors"
11021724|NCT01161043|FG000|Participant Flow|Sensor|"All subjects that wear sensors (all subjects)~Sensor wear: All subjects to wear sensors"
11021725|NCT01161043|OG000|Outcome|Subjects Wearing Sensors|"All subjects that wear sensors (all subjects)~Sensor wear: All subjects to wear sensors"
11021726|NCT01161043|EG000|Reported Event|Subjects Wearing Sensors|"All subjects that wear sensors (all subjects)~Sensor wear: All subjects to wear sensors"
11021727|NCT01161121|BG000|Baseline|Adenosine, Regadenoson|Each patient underwent standard intravenous adenosine infusion (140mcg/kg/min) with invasive pressure recordings for 2 min, or until maximal hyperemia occurred. Five minutes after return to baseline hemodynamics, a single intravenous bolus of 0.4 mg regadenoson was administered, and pressures were recorded for 5 min. FFR values were compared by linear regression and Bland-Altman analysis.
11021728|NCT01161121|FG000|Participant Flow|Adenosine Then Regadenoson|"Adenosine infusion will be compared to Regadenoson for efficacy and safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. All patients to receive Adenosine infusion followed by Regadenoson IV bolus upon return of coronary flow velocity to 15% of pre-dose value.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia.~Regadenoson : Administration of IV regadenoson bolus 0.4 mg/5 mls over 10 seconds followed by a 5 cc NS saline flush"
11021729|NCT01161121|OG000|Outcome|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia"
11021730|NCT01161121|OG001|Outcome|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
11021731|NCT01161121|OG000|Outcome|Adenosine|With infusion of 140 mcg/kg/min
11021732|NCT01161121|OG001|Outcome|Regadenosine|With bolus infusion of 0.4 mg
11021733|NCT01161121|EG000|Reported Event|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia~adenosine : Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
11021734|NCT01161121|EG001|Reported Event|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value then Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml. Then, a 5 cc saline flush will be administered.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
11021735|NCT01161160|BG000|Baseline|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021736|NCT01161160|BG001|Baseline|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021737|NCT01161160|BG002|Baseline|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021738|NCT01161160|BG003|Baseline|Total|Total of all reporting groups
11021739|NCT01161160|FG000|Participant Flow|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021740|NCT01161160|FG001|Participant Flow|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021741|NCT01161160|FG002|Participant Flow|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021742|NCT01161160|OG000|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021743|NCT01161160|OG001|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021744|NCT01161160|OG002|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021745|NCT01161160|EG000|Reported Event|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021746|NCT01161160|EG001|Reported Event|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021747|NCT01161160|EG002|Reported Event|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
11021748|NCT01161173|BG000|Baseline|Cohort|Participants in the observational cohort received second-line therapy with Tarceva. At the time of discontinuation of Tarceva, a third-line chemotherapy or best supportive care were initiated as appropriate.
11021749|NCT01161173|FG000|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
11021750|NCT01161173|OG000|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
11021751|NCT01161173|EG000|Reported Event|Erlotinib|"Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.~Erlotinib: Erlotinib was provided in the retail versions of the product."
10886337|NCT00493246|EG005|Reported Event|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886338|NCT00493246|EG006|Reported Event|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886339|NCT00493246|EG007|Reported Event|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
10886340|NCT00493285|BG000|Baseline|10^4 MEDI-534|
10886341|NCT00493285|BG001|Baseline|10^4 PLACEBO|
10886342|NCT00493285|BG002|Baseline|10^5 MEDI-534|
10886343|NCT00493285|BG003|Baseline|10^5 PLACEBO|
10886344|NCT00493285|BG004|Baseline|10^6 MEDI-534|
11021752|NCT01161225|BG000|Baseline|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021753|NCT01161225|BG001|Baseline|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
10886345|NCT00493285|BG005|Baseline|10^6 PLACEBO|
10886346|NCT00493285|BG006|Baseline|TOTAL|Total of all reporting groups
10886347|NCT00493285|FG000|Participant Flow|10^4 MEDI-534|
10886348|NCT00493285|FG001|Participant Flow|10^4 PLACEBO|
10886349|NCT00493285|FG002|Participant Flow|10^5 MEDI-534|
10886350|NCT00493285|FG003|Participant Flow|10^5 PLACEBO|
10886351|NCT00493285|FG004|Participant Flow|10^6 MEDI-534|
10886352|NCT00493285|FG005|Participant Flow|10^6 PLACEBO|
10886353|NCT00493285|OG000|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
10886354|NCT00493285|OG001|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
10886355|NCT00493285|OG002|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
10886356|NCT00493285|OG003|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
10886357|NCT00493285|OG004|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
10886358|NCT00493285|OG005|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
10886359|NCT00493285|EG000|Reported Event|10^4 MEDI-534|
10886360|NCT00493285|EG001|Reported Event|10^4 PLACEBO|
10886361|NCT00493285|EG002|Reported Event|10^5 MEDI-534|
10886362|NCT00493285|EG003|Reported Event|10^5 PLACEBO|
10886363|NCT00493285|EG004|Reported Event|10^6 MEDI-534|
10886364|NCT00493285|EG005|Reported Event|10^6 PLACEBO|
10886365|NCT00493311|BG000|Baseline|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
10886366|NCT00493311|BG001|Baseline|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
10886367|NCT00493311|BG002|Baseline|Total|Total of all reporting groups
10886368|NCT00493311|FG000|Participant Flow|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
10886369|NCT00493311|FG001|Participant Flow|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
10886370|NCT00493311|OG000|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
10886371|NCT00493311|OG001|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
10886372|NCT00493311|EG000|Reported Event|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
10886373|NCT00493311|EG001|Reported Event|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
10886374|NCT00493454|BG000|Baseline|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
10886375|NCT00493454|FG000|Participant Flow|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
10886376|NCT00493454|OG000|Outcome|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
11021754|NCT01161225|BG002|Baseline|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021755|NCT01161225|BG003|Baseline|Total|Total of all reporting groups
11021756|NCT01161225|FG000|Participant Flow|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021757|NCT01161225|FG001|Participant Flow|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021758|NCT01161225|FG002|Participant Flow|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021759|NCT01161225|OG000|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021760|NCT01161225|OG001|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021761|NCT01161225|OG002|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021762|NCT01161225|OG000|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months
11021763|NCT01161225|OG000|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program.
11021764|NCT01161225|OG001|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program
11021765|NCT01161225|OG002|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders
11021766|NCT01161225|EG000|Reported Event|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021767|NCT01161225|EG001|Reported Event|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021768|NCT01161225|EG002|Reported Event|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
11021769|NCT01161329|BG000|Baseline|Controlgroup|Ordinary life.
11021770|NCT01161329|BG001|Baseline|Intervention Group|High Intensity Functional Exercise Program
11021771|NCT01161329|BG002|Baseline|Total|Total of all reporting groups
11021772|NCT01161329|FG000|Participant Flow|Controlgroup|Instructed to live their ordinary life.
11021773|NCT01161329|FG001|Participant Flow|Intervention Group|High-Intensity Functional Exercise Program (HIFE) in combination with motivational group discussions two times a week. .
10886377|NCT00493454|EG000|Reported Event|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
11021774|NCT01161329|OG000|Outcome|Controlgroup|Ordinary life.
11021775|NCT01161329|OG001|Outcome|Intervention Group|High Intensity Functional Exercise Program
11021776|NCT01161329|OG001|Outcome|Group Exercise Program|High-Intensity Functional Exercise Program
11021777|NCT01161329|EG000|Reported Event|Controlgroup|Ordinary life.
11021778|NCT01161329|EG001|Reported Event|Intervention Group|High Intensity Functional Exercise Program
11021779|NCT01161407|BG000|Baseline|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
11021780|NCT01161407|BG001|Baseline|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
11021781|NCT01161407|BG002|Baseline|Total|Total of all reporting groups
11021782|NCT01161407|FG000|Participant Flow|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
11021783|NCT01161407|FG001|Participant Flow|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
11021784|NCT01161407|OG000|Outcome|Placebo|
11021785|NCT01161407|OG001|Outcome|Calcium|
11021786|NCT01161407|EG000|Reported Event|Placebo|
11021787|NCT01161407|EG001|Reported Event|Calcium|
11021788|NCT01161420|BG000|Baseline|Inspire Therapy|"Study subjects continue to use Inspire therapy~Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration."
11021789|NCT01161420|FG000|Participant Flow|Inspire Therapy|126 subjects were implanted with Inspire therapy
11021790|NCT01161420|OG000|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
11021791|NCT01161420|OG000|Outcome|All Subjects|126 implanted study subjects
11021792|NCT01161420|OG000|Outcome|Maintenance|Twenty-three (23) patients were in the therapy maintenance (ON) group
11021793|NCT01161420|OG001|Outcome|Withdrawal|Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
11021794|NCT01161420|OG000|Outcome|Inspire Therapy|126 subjects implanted with Inspire therapy
11021795|NCT01161420|OG000|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
11021796|NCT01161420|OG000|Outcome|Inspire Therapy|126 subjects were implanted with Inspire therapy; 124 subjects completed this visit (two expired prior to the 12-month visit).
11021797|NCT01161420|EG000|Reported Event|Inspire Therapy|This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
11021798|NCT01161446|BG000|Baseline|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
11021799|NCT01161446|BG001|Baseline|Standard Testing|HIV testing as usual.
11021800|NCT01161446|BG002|Baseline|Total|Total of all reporting groups
11021801|NCT01161446|FG000|Participant Flow|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
11021802|NCT01161446|FG001|Participant Flow|Standard Testing|HIV testing as usual.
11021803|NCT01161446|OG000|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
11021804|NCT01161446|OG001|Outcome|Standard Testing|HIV testing as usual.
11021805|NCT01161446|EG000|Reported Event|Home Testing|"Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.~Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: The device is the home HIV self-testing kit that includes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use on oral fluids. The kit itself is not the focus of this trial. As described in the Behavioral Intervention section, the intervention is having access to home self-testing for HIV."
11021806|NCT01161446|EG001|Reported Event|Standard Testing|HIV testing as usual.
11021807|NCT01161472|BG000|Baseline|Entire Study Population|All participants randomized to any treatment (fesoterodine 4 mg tablet first, fesoterodine 8 mg tablet first, alprazolam 1 mg capsule first and placebo first).
11021808|NCT01161472|FG000|Participant Flow|Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg|Fesoterodine 4 milligram (mg) tablet administered orally once daily (OD) for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
11021809|NCT01161472|FG001|Participant Flow|Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
11021810|NCT01161472|FG002|Participant Flow|Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
11021811|NCT01161472|FG003|Participant Flow|Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
11021812|NCT01161472|OG000|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
11021813|NCT01161472|OG001|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
11021814|NCT01161472|OG002|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
11021815|NCT01161472|OG003|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
11021816|NCT01161472|EG000|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
11021817|NCT01161472|EG001|Reported Event|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
11021818|NCT01161472|EG002|Reported Event|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
11021819|NCT01161472|EG003|Reported Event|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
11021820|NCT01161498|BG000|Baseline|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
11021821|NCT01161498|BG001|Baseline|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
11021822|NCT01161498|BG002|Baseline|Total|Total of all reporting groups
11021823|NCT01161498|FG000|Participant Flow|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
11021824|NCT01161498|FG001|Participant Flow|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming units (PFU)/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
11021825|NCT01161498|OG000|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
11021826|NCT01161498|OG001|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
11021827|NCT01161498|EG000|Reported Event|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
11021828|NCT01161498|EG001|Reported Event|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
11021829|NCT01161524|BG000|Baseline|Perampenal (Core Study)|Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.
11021830|NCT01161524|BG001|Baseline|Placebo (Core Study)|Participants received matching placebo tablets once a day (6 tablets of placebo).
11021831|NCT01161524|BG002|Baseline|Total|Total of all reporting groups
11021832|NCT01161524|FG000|Participant Flow|Perampanel (Core Study)|Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.
11021833|NCT01161524|FG001|Participant Flow|Placebo (Core Study)|Participants received matching placebo tablets once a day (6 tablets of placebo).
11021834|NCT01161524|FG002|Participant Flow|Perampanel (Extension Phase)|During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.
11021835|NCT01161524|OG000|Outcome|Perampanel (Core Study)|Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.
11021836|NCT01161524|OG001|Outcome|Placebo (Core Study)|Participants received matching placebo tablets once a day (6 tablets of placebo).
11021837|NCT01161524|OG000|Outcome|Perampanel (Extension Phase)|During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.
11021838|NCT01161524|OG000|Outcome|Perampanel (Extension Phase)|During the Extension phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.
11021839|NCT01161524|EG000|Reported Event|Perampanel (Core Study)|Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.
11021840|NCT01161524|EG001|Reported Event|Placebo (Core Study)|Participants received matching placebo tablets once a day (6 tablets of placebo).
11021841|NCT01161524|EG002|Reported Event|Perampanel (Extension Phase)|During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.
11021842|NCT01161537|BG000|Baseline|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
11021843|NCT01161537|FG000|Participant Flow|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 milligram (mg) orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
11021844|NCT01161537|OG000|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
11021845|NCT01161537|OG000|Outcome|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
11021846|NCT01161537|OG001|Outcome|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
11021847|NCT01161537|OG000|Outcome|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
11021848|NCT01161537|EG000|Reported Event|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
11021849|NCT01161537|EG001|Reported Event|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
11021850|NCT01161537|EG002|Reported Event|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
11021851|NCT01161563|BG000|Baseline|Leuprolide Acetate First, Then Triptorelin|Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area 6 months before injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
11021852|NCT01161563|BG001|Baseline|Triptorelin First, Then Leuprolide Acetate|Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock 6 months before injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.
11021853|NCT01161563|BG002|Baseline|Total|Total of all reporting groups
11021854|NCT01161563|FG000|Participant Flow|Triptorelin First, Then Leuprolide Acetate|"Injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock, followed 6 months later by injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area.~A detailed breakdown of participant flow by treatment period for each arm is not available."
11021855|NCT01161563|FG001|Participant Flow|Leuprolide Acetate First, Then Triptorelin|"Injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area, followed 6 months later by injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.~A detailed breakdown of participant flow by treatment period for each arm is not available."
11021856|NCT01161563|OG000|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
11021857|NCT01161563|OG001|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
11021858|NCT01161563|EG000|Reported Event|Leuprolide Acetate|
11021859|NCT01161563|EG001|Reported Event|Triptorelin Pamoate|
11021860|NCT01161628|BG000|Baseline|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
11021861|NCT01161628|FG000|Participant Flow|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
11021862|NCT01161628|OG000|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
11021863|NCT01161628|EG000|Reported Event|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
11021864|NCT01161771|BG000|Baseline|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
11021865|NCT01161771|FG000|Participant Flow|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
11021866|NCT01161771|OG000|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
11021867|NCT01161771|EG000|Reported Event|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
11021868|NCT01161862|BG000|Baseline|Bi-hormonal Pancreas With Meal-priming Bolus|An automatically adapting meal priming bolus was given by the controller at the time each meal was presented
11021869|NCT01161862|BG001|Baseline|Bi-hormonal Pancreas Without Meal-priming Bolus|The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
11021870|NCT01161862|BG002|Baseline|Total|Total of all reporting groups
11021871|NCT01161862|FG000|Participant Flow|Bi-hormonal Bionic Pancreas With Meal-priming Bolus|The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal.
11021872|NCT01161862|FG001|Participant Flow|Bi-hormonal Bionic Pancreas With no Meal-priming Bolus|Bi-hormonal bionic pancreas with no meal-priming bolus. The controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
11021873|NCT01161862|OG000|Outcome|Bionic Pancreas With Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
11021874|NCT01161862|OG001|Outcome|Bionic Pancreas Without Automated Meal-priming Bolus|
11021875|NCT01161862|OG000|Outcome|Bi-hormonal With Meal Priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
11021876|NCT01161862|OG001|Outcome|Bi-hormonal Without Meal Priming Bolus|
11021877|NCT01161862|OG001|Outcome|Bionic Pancreas Without Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
11021878|NCT01161862|EG000|Reported Event|Bi-hormonal With Meal Priming Bolus|Bi-hormonal with adaptive meal priming bolus
11021879|NCT01161862|EG001|Reported Event|Bi-hormonal Without Meal Priming Bolus|Bi-hormonal with no meal announcements or meal priming boluses
11021880|NCT01162005|BG000|Baseline|SDNS/FRNS Group|"SDNS: steroid dependent nephrotic syndrome FRNS: frequent relapsing nephrotic syndrome~Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months"
11021881|NCT01162005|BG001|Baseline|SRNS Group|"SRNS: steroid resistant nephrotic syndrome~Absence of remission after four weeks of steroid therapy."
11021882|NCT01162005|BG002|Baseline|Total|Total of all reporting groups
11021883|NCT01162005|FG000|Participant Flow|SDNS/FRNS Group|"Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months~SDNS: steroid-dependent nephrotic syndrome; FRNS: frequent-relapsing nephrotic syndrome;"
11021884|NCT01162005|FG001|Participant Flow|SRNS Group|Absence of remission after four weeks of steroid therapy SRNS: steroid-resistant nephrotic syndrome
11021885|NCT01162005|OG000|Outcome|SDNS/FRNS|Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months
11021886|NCT01162005|OG001|Outcome|SRNS|Absence of remission after four weeks of steroid therapy
11021887|NCT01162005|OG000|Outcome|SDNS/FRNS Group|Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months
11021888|NCT01162005|OG001|Outcome|SRNS Group|Absence of remission after four weeks of steroid therapy
11021889|NCT01162005|EG000|Reported Event|SDNS/FRNS Group|Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months
11021890|NCT01162005|EG001|Reported Event|SRNS Group|Absence of remission after four weeks of steroid therapy
11021891|NCT01162096|BG000|Baseline|Transplantation|
11021892|NCT01162096|FG000|Participant Flow|Transplantation|
11021893|NCT01162096|OG000|Outcome|Transplantation|
11021894|NCT01162096|OG000|Outcome|Transplantation|Haploidentical Allogeneic Transplantation: Patients undergoing reduced intensity haploidentical hematopoietic stem cell transplant from a partially matched related donor.
11021895|NCT01162096|EG000|Reported Event|Transplantation|
11021896|NCT01162122|BG000|Baseline|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
11021897|NCT01162122|BG001|Baseline|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
11021898|NCT01162122|BG002|Baseline|Total|Total of all reporting groups
11021899|NCT01162122|FG000|Participant Flow|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
11021900|NCT01162122|FG001|Participant Flow|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
11021901|NCT01162122|OG000|Outcome|aTIV_Lot 1|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
11021902|NCT01162122|OG001|Outcome|aTIV_Lot 2|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
11021903|NCT01162122|OG002|Outcome|aTIV_Lot 3|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
11021904|NCT01162122|OG000|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
11021905|NCT01162122|OG001|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
11021906|NCT01162122|EG000|Reported Event|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
11021907|NCT01162122|EG001|Reported Event|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
11021908|NCT01162135|BG000|Baseline|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
11021909|NCT01162135|FG000|Participant Flow|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
11021910|NCT01162135|OG000|Outcome|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
11021911|NCT01162135|EG000|Reported Event|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
11021912|NCT01162239|BG000|Baseline|Extended Brief Contact|"Following standard brief treatment, participants have monthly meetings with medical staff.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff."
11021913|NCT01162239|BG001|Baseline|Extended Health Education|"Following standard treatment, participants receive monthly counseling with content based on a health education model.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021914|NCT01162239|BG002|Baseline|Extended Relapse Prevention Plus Varenicline|"Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021915|NCT01162239|BG003|Baseline|Extended Relapse Prevention|"Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021916|NCT01162239|BG004|Baseline|Total|Total of all reporting groups
11021917|NCT01162239|FG000|Participant Flow|Extended Brief Contact|"Following standard brief treatment, participants have monthly meetings with medical staff.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff."
11021918|NCT01162239|FG001|Participant Flow|Extended Health Education|"Following standard treatment, participants receive monthly counseling with content based on a health education model.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021919|NCT01162239|FG002|Participant Flow|Extended Relapse Prevention Plus Varenicline|"Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021920|NCT01162239|FG003|Participant Flow|Extended Relapse Prevention|"Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021921|NCT01162239|OG000|Outcome|Extended Brief Contact|"Following standard brief treatment, participants have monthly meetings with medical staff.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff."
11021922|NCT01162239|OG001|Outcome|Extended Health Education|"Following standard treatment, participants receive monthly counseling with content based on a health education model.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021923|NCT01162239|OG002|Outcome|Extended Relapse Prevention Plus Varenicline|"Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021924|NCT01162239|OG003|Outcome|Extended Relapse Prevention|"Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021925|NCT01162239|OG001|Outcome|Combined Extended Treatments|"Patients in the extended treatments were offered the followint:~Following standard treatment, participants receive monthly counseling with content based on a health education model.~or~Eleven individual counseling sessions across a nine month period plus Varenicline.Each session 30-45 minutes in duration with a focus on relapse prevention~or~Eleven individual counseling sessions across a nine month period. Each session 30-45 minutes in duration with a focus on relapse prevention"
11021926|NCT01162239|EG000|Reported Event|Extended Brief Contact|"Following standard brief treatment, participants have monthly meetings with medical staff.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff."
11021927|NCT01162239|EG001|Reported Event|Extended Health Education|"Following standard treatment, participants receive monthly counseling with content based on a health education model.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021928|NCT01162239|EG002|Reported Event|Extended Relapse Prevention Plus Varenicline|"Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11066219|NCT01391130|FG000|Participant Flow|LY2510924 + Sunitinib|LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
11341297|NCT03680521|EG000|Reported Event|Sitravatinib 120 mg|Participants received sitravatinib orally, once a day, at a dose of 120 mg for 2 weeks (segment 1). Then, the participants continued to receive sitravatinib in combination with nivolumab 240 mg administered as an intravenous (IV) infusion every 2 weeks, for a maximum of 6 additional weeks (segment 2).
11021929|NCT01162239|EG003|Reported Event|Extended Relapse Prevention|"Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.~Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.~Individual counseling: Five 90 minute individual counseling sessions.~individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration."
11021930|NCT01162317|BG000|Baseline|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
11021931|NCT01162317|BG001|Baseline|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
11021932|NCT01162317|BG002|Baseline|Total|Total of all reporting groups
11021933|NCT01162317|FG000|Participant Flow|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
11021934|NCT01162317|FG001|Participant Flow|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
11021935|NCT01162317|OG000|Outcome|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
11021936|NCT01162317|OG001|Outcome|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
11021937|NCT01162317|EG000|Reported Event|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
11021938|NCT01162317|EG001|Reported Event|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
11021939|NCT01162343|BG000|Baseline|Older Emergency Department Patients|Patients who were 65 years or older from the emergency department were enrolled.
11021940|NCT01162343|FG000|Participant Flow|Older Emergency Department Patients|Patients who were 65 years or older from the emergency department were enrolled.
11021941|NCT01162343|OG000|Outcome|Older Emergency Department Patients|Patients who were 65 years or older from the emergency department were enrolled.
11021942|NCT01162343|EG000|Reported Event|Older Emergency Department Patients|Patients who were 65 years or older from the emergency department were enrolled.
11021943|NCT01162421|BG000|Baseline|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
11021944|NCT01162421|BG001|Baseline|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
11021945|NCT01162421|BG002|Baseline|Total|Total of all reporting groups
11021946|NCT01162421|FG000|Participant Flow|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
11021947|NCT01162421|FG001|Participant Flow|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
11021948|NCT01162421|OG000|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
11021949|NCT01162421|OG001|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
11021950|NCT01162421|EG000|Reported Event|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
11021951|NCT01162421|EG001|Reported Event|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
11021952|NCT01162473|BG000|Baseline|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
11021953|NCT01162473|BG001|Baseline|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
11021954|NCT01162473|BG002|Baseline|Total|Total of all reporting groups
11021955|NCT01162473|FG000|Participant Flow|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
11021956|NCT01162473|FG001|Participant Flow|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
11021957|NCT01162473|OG000|Outcome|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
11021958|NCT01162473|OG001|Outcome|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
11021959|NCT01162473|EG000|Reported Event|Delayed Desensitization|Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder (42 week protocol).
11021960|NCT01162473|EG001|Reported Event|Immediate Desensitization|Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder (29 week protocol)
11021961|NCT01162486|BG000|Baseline|Rifampin Control|"Rifampin + midazolam~Rifampin & midazolam: rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021962|NCT01162486|BG001|Baseline|RPT 1|"RPT Cohort 1 - 5 mg/kg~rifapentine & midazolam: rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021963|NCT01162486|BG002|Baseline|RPT 2|"RPT Cohort 2 - 10 mg/kg~rifapentine & midazolam: rifapentine - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021964|NCT01162486|BG003|Baseline|RPT 3|"RPT Cohort 3 - 15 mg/kg~rifapentine & midazolam: rifapentine - tablet, 15 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021965|NCT01162486|BG004|Baseline|RPT 4|"RPT Cohort 4 - 20 mg/kg~rifapentine and midazolam: rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021966|NCT01162486|BG005|Baseline|Total|Total of all reporting groups
11021967|NCT01162486|FG000|Participant Flow|Rifampin Control|"Rifampin + midazolam~Rifampin & midazolam: rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021968|NCT01162486|FG001|Participant Flow|RPT 1|"RPT Cohort 1 - 5 mg/kg~rifapentine & midazolam: rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021969|NCT01162486|FG002|Participant Flow|RPT 2|"RPT Cohort 2 - 10 mg/kg~rifapentine & midazolam: rifapentine - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021970|NCT01162486|FG003|Participant Flow|RPT 3|"RPT Cohort 3 - 15 mg/kg~rifapentine & midazolam: rifapentine - tablet, 15 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021971|NCT01162486|FG004|Participant Flow|RPT 4|"RPT Cohort 4 - 20 mg/kg~rifapentine and midazolam: rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021972|NCT01162486|OG000|Outcome|Rifampin Control|"Rifampin + midazolam~Rifampin & midazolam: rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021973|NCT01162486|OG001|Outcome|RPT 1|"RPT Cohort 1 - 5 mg/kg~rifapentine & midazolam: rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021974|NCT01162486|OG002|Outcome|RPT 2|"RPT Cohort 2 - 10 mg/kg~rifapentine & midazolam: rifapentine - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021975|NCT01162486|OG003|Outcome|RPT 3|"RPT Cohort 3 - 15 mg/kg~rifapentine & midazolam: rifapentine - tablet, 15 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021976|NCT01162486|OG004|Outcome|RPT 4|"RPT Cohort 4 - 20 mg/kg~rifapentine and midazolam: rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021977|NCT01162486|OG000|Outcome|RPT 1|"RPT Cohort 1 - 5 mg/kg~rifapentine & midazolam: rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021978|NCT01162486|OG001|Outcome|RPT 2|"RPT Cohort 2 - 10 mg/kg~rifapentine & midazolam: rifapentine - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021979|NCT01162486|OG002|Outcome|RPT 3|"RPT Cohort 3 - 15 mg/kg~rifapentine & midazolam: rifapentine - tablet, 15 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021980|NCT01162486|OG003|Outcome|RPT 4|"RPT Cohort 4 - 20 mg/kg~rifapentine and midazolam: rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021981|NCT01162486|EG000|Reported Event|Rifampin Control|"Rifampin + midazolam~Rifampin & midazolam: rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021982|NCT01162486|EG001|Reported Event|RPT 1|"RPT Cohort 1 - 5 mg/kg~rifapentine & midazolam: rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021983|NCT01162486|EG002|Reported Event|RPT 2|"RPT Cohort 2 - 10 mg/kg~rifapentine & midazolam: rifapentine - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021984|NCT01162486|EG003|Reported Event|RPT 3|"RPT Cohort 3 - 15 mg/kg~rifapentine & midazolam: rifapentine - tablet, 15 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021985|NCT01162486|EG004|Reported Event|RPT 4|"RPT Cohort 4 - 20 mg/kg~rifapentine and midazolam: rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15"
11021986|NCT01162499|BG000|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
11021987|NCT01162499|FG000|Participant Flow|Exendin-(9-39) First, Then Vehicle|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects. The next day, all procedures were repeated except subjects received an IV infusion of normal saline (vehicle) over 4 hours.
11021988|NCT01162499|FG001|Participant Flow|Vehicle First, Then Exendin-(9-39)|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The next day, all procedures were repeated except subjects received an IV infusion of Exendin-(9-39) which was started 1 hour prior to the meal challenge and continued for 4 hours. The dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects.
11021989|NCT01162499|OG000|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
11021990|NCT01162499|OG001|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
11021991|NCT01162499|OG002|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
11021992|NCT01162499|EG000|Reported Event|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
11021993|NCT01162499|EG001|Reported Event|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
11066220|NCT01391130|FG001|Participant Flow|Sunitinib|50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
10886378|NCT00493467|BG000|Baseline|Zevalin|Ibritumomab Tiuxetan (Zevalin): 111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) intravenous (IV) over 10 minutes on Day 1; 90Y Zevalin 0.3 or 0.4 mCi/kg IV over 10 minutes on Day 8. Rituximab: 250 mg/m^2 IV over 4-6 Hours on Days 1 and 8 prior to the administration of 111In Zevalin and 90Y Zevalin, respectively.
10886379|NCT00493467|FG000|Participant Flow|Zevalin|Ibritumomab Tiuxetan (Zevalin): 111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) intravenous (IV) over 10 minutes on Day 1; 90Y Zevalin 0.3 or 0.4 mCi/kg IV over 10 minutes on Day 8. Rituximab: 250 mg/m^2 IV over 4-6 Hours on Days 1 and 8 prior to the administration of 111In Zevalin and 90Y Zevalin, respectively.
10886380|NCT00493467|OG000|Outcome|Zevalin|Ibritumomab Tiuxetan (Zevalin): 111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) intravenous (IV) over 10 minutes on Day 1; 90Y Zevalin 0.3 or 0.4 mCi/kg IV over 10 minutes on Day 8. Rituximab: 250 mg/m^2 IV over 4-6 Hours on Days 1 and 8 prior to the administration of 111In Zevalin and 90Y Zevalin, respectively.
10886381|NCT00493467|EG000|Reported Event|Zevalin|Ibritumomab Tiuxetan (Zevalin): 111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) intravenous (IV) over 10 minutes on Day 1; 90Y Zevalin 0.3 or 0.4 mCi/kg IV over 10 minutes on Day 8. Rituximab: 250 mg/m^2 IV over 4-6 Hours on Days 1 and 8 prior to the administration of 111In Zevalin and 90Y Zevalin, respectively.
10886382|NCT00493636|BG000|Baseline|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
10886383|NCT00493636|BG001|Baseline|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
10886384|NCT00493636|BG002|Baseline|Total|Total of all reporting groups
10886385|NCT00493636|FG000|Participant Flow|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
10886386|NCT00493636|FG001|Participant Flow|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
10886387|NCT00493636|OG000|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
10886388|NCT00493636|OG001|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
10886389|NCT00493636|EG000|Reported Event|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
11021994|NCT01162499|EG002|Reported Event|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
11021995|NCT01162551|BG000|Baseline|Sirolimus and Methotrexate|"Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.~One cycle is 28 days~Sirolimus and Methotrexate: Single Arm Efficacy Trial:~Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.~One cycle is 28 days."
11021996|NCT01162551|FG000|Participant Flow|Sirolimus and Methotrexate|"Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.~One cycle is 28 days~Sirolimus and Methotrexate: Single Arm Efficacy Trial:~Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.~One cycle is 28 days."
11021997|NCT01162551|OG000|Outcome|Sirolimus and Methotrexate|"Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.~One cycle is 28 days~Sirolimus and Methotrexate: Single Arm Efficacy Trial:~Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.~One cycle is 28 days."
11021998|NCT01162551|EG000|Reported Event|Sirolimus and Methotrexate|"Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.~One cycle is 28 days~Sirolimus and Methotrexate: Single Arm Efficacy Trial:~Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.~One cycle is 28 days."
11021999|NCT01162733|BG000|Baseline|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
11022000|NCT01162733|BG001|Baseline|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
11022001|NCT01162733|BG002|Baseline|Total|Total of all reporting groups
11022002|NCT01162733|FG000|Participant Flow|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
11022003|NCT01162733|FG001|Participant Flow|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
11022004|NCT01162733|OG000|Outcome|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
11022005|NCT01162733|OG001|Outcome|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
11022006|NCT01162733|EG000|Reported Event|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
11022007|NCT01162733|EG001|Reported Event|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
11022008|NCT01162863|BG000|Baseline|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022009|NCT01162863|BG001|Baseline|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022010|NCT01162863|BG002|Baseline|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022011|NCT01162863|BG003|Baseline|Total|Total of all reporting groups
11022012|NCT01162863|FG000|Participant Flow|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022013|NCT01162863|FG001|Participant Flow|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022014|NCT01162863|FG002|Participant Flow|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022015|NCT01162863|OG000|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022016|NCT01162863|OG001|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
10886390|NCT00493636|EG001|Reported Event|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
10886391|NCT00493649|BG000|Baseline|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
10886392|NCT00493649|FG000|Participant Flow|TC+H|This is a nonrandomized, noncomparative, open-label Phase II study. On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive docetaxel (Taxotere) 75 mg/m^2 IV plus cyclophosphamide (Cytoxan) 600 mg/m^2 IV, plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, Day 1, Cycle 1 only) and 2 mg/kg IV (on Days 1, 8, and 15) thereafter. Subsequent cycles of therapy will continue until a total of 4 cycles of TC+H have been completed. Then, patients will continue to receive trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care.
10886393|NCT00493649|OG000|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
10886394|NCT00493649|OG001|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
10886395|NCT00493649|OG000|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
10886396|NCT00493649|OG001|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
10886397|NCT00493649|EG000|Reported Event|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
10886398|NCT00493779|BG000|Baseline|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
10886399|NCT00493779|FG000|Participant Flow|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
10886400|NCT00493779|OG000|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
10886401|NCT00493779|OG000|Outcome|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
10886402|NCT00493779|EG000|Reported Event|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
10886403|NCT00493805|BG000|Baseline|Total for Interventional Arm and Non Interventional Arm|
10886404|NCT00493805|FG000|Participant Flow|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
10886405|NCT00493805|FG001|Participant Flow|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
10886406|NCT00493805|OG000|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
10886407|NCT00493805|OG001|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
10886408|NCT00493805|EG000|Reported Event|Non Interventional Arm HOMA IR <=2|
10886409|NCT00493805|EG001|Reported Event|Interventional Arm HOMA IR >2|
10886410|NCT00493974|BG000|Baseline|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
10886411|NCT00493974|BG001|Baseline|Placebo|Matching placebo 4 times a day
10886412|NCT00493974|BG002|Baseline|Total|Total of all reporting groups
10886413|NCT00493974|FG000|Participant Flow|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
10886414|NCT00493974|FG001|Participant Flow|Placebo|Matching placebo 4 times a day
10886415|NCT00493974|OG000|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
10886416|NCT00493974|OG001|Outcome|Placebo|Matching placebo 4 times a day
10886417|NCT00493974|EG000|Reported Event|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
10886418|NCT00493974|EG001|Reported Event|Placebo|Matching placebo 4 times a day
10886419|NCT00494013|BG000|Baseline|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
10886420|NCT00494013|BG001|Baseline|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
10886421|NCT00494013|BG002|Baseline|Total|Total of all reporting groups
11022017|NCT01162863|OG002|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022018|NCT01162863|EG000|Reported Event|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022019|NCT01162863|EG001|Reported Event|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022020|NCT01162863|EG002|Reported Event|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
11022021|NCT01163032|BG000|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
11022022|NCT01163032|BG001|Baseline|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
11022023|NCT01163032|BG002|Baseline|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
11022024|NCT01163032|BG003|Baseline|Total|Total of all reporting groups
11022025|NCT01163032|FG000|Participant Flow|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
11022026|NCT01163032|FG001|Participant Flow|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
11022027|NCT01163032|FG002|Participant Flow|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
10886422|NCT00494013|FG000|Participant Flow|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
11022028|NCT01163032|OG000|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
11022029|NCT01163032|OG001|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
11022030|NCT01163032|OG000|Outcome|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
11022031|NCT01163032|EG000|Reported Event|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
11022032|NCT01163032|EG001|Reported Event|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
11022033|NCT01163032|EG002|Reported Event|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
11022034|NCT01163097|BG000|Baseline|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
11022035|NCT01163097|BG001|Baseline|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
11022036|NCT01163097|BG002|Baseline|Untreated Control|Treatment C: control group without any treatment administered
11022037|NCT01163097|BG003|Baseline|Total|Total of all reporting groups
11022038|NCT01163097|FG000|Participant Flow|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
11022039|NCT01163097|FG001|Participant Flow|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
11022040|NCT01163097|FG002|Participant Flow|Untreated Control|Treatment C: control group without any treatment administered
11022041|NCT01163097|OG000|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
11022042|NCT01163097|OG001|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
11022043|NCT01163097|OG000|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
11022044|NCT01163097|OG001|Outcome|Untreated Control|Treatment C: control group without any treatment administered
11022045|NCT01163097|OG002|Outcome|Untreated Control|Treatment C: control group without any treatment administered
11022046|NCT01163097|EG000|Reported Event|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
11022047|NCT01163097|EG001|Reported Event|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
11022048|NCT01163097|EG002|Reported Event|Untreated Control|Treatment C: control group without any treatment administered
11022049|NCT01163149|BG000|Baseline|0.3 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11148708|NCT01866410|BG000|Baseline|Cabozantinib-s-malate, Erlotinib Hydrochloride|"Patients will receive (A) XL184 (cabozantinib) at 40-mg p.o. daily plus erlotinib at 150-mg p.o. daily in 4-week cycles. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Erlotinib Hydrochloride: Given PO"
10886423|NCT00494013|FG001|Participant Flow|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
11022050|NCT01163149|BG001|Baseline|0.5 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022051|NCT01163149|BG002|Baseline|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects randomized to the concurrent control cohort were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug"
11022052|NCT01163149|BG003|Baseline|Total|Total of all reporting groups
11022053|NCT01163149|FG000|Participant Flow|0.3 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022054|NCT01163149|FG001|Participant Flow|0.5 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022055|NCT01163149|FG002|Participant Flow|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022056|NCT01163149|OG000|Outcome|0.3 mg/kg Asfotase Alfa|Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total)
11022057|NCT01163149|OG001|Outcome|0.5 mg/kg Asfotase Alfa|Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total)
11022058|NCT01163149|OG002|Outcome|Concurrent Control|Control (no asfotase alfa) during primary treatment period (first 24 weeks)
11022059|NCT01163149|OG003|Outcome|Combined Asfotase Alfa Group|Subjects from Cohort 1 and Cohort 2 treated with asfotase alfa during primary treatment period (first 24 weeks)
11022060|NCT01163149|OG000|Outcome|0.3 mg/kg Asfotase Alfa|Primary Treatment Period (first 24 week). Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total).
11022061|NCT01163149|OG001|Outcome|0.5 mg/kg Asfotase Alfa|Primary Treatment Period (first 24 weeks). Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total).
11022062|NCT01163149|OG002|Outcome|Concurrent Control|No asfotase alfa during primary treatment period: (first 24 weeks).
11022063|NCT01163149|OG003|Outcome|Cumulative Exposure to Asfotase Alfa|All subjects from Cohort 1, Cohort 2, or Control group with any asfotase alfa exposure. During primary treatment period, N=13. During open-label extension treatment period, N=19.
11022064|NCT01163149|OG000|Outcome|0.3 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022065|NCT01163149|OG001|Outcome|0.5 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022066|NCT01163149|OG002|Outcome|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022067|NCT01163149|OG003|Outcome|Asfotase Alfa Combined|All subjects from Cohort 1, Cohort 2, or Control group with any asfotase alfa exposure. During primary treatment period, N=13. During open-label extension treatment period, N=19.
11022068|NCT01163149|OG000|Outcome|0.3 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022069|NCT01163149|OG001|Outcome|0.5 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
11022070|NCT01163149|OG003|Outcome|Asfotase Alfa Combined|Subjects From Cohort 1 and Cohort 2 treated with asfotase alfa (N=13) during Primary Treatment Period, and all subjects exposed to asfotase alfa (N=19) during extension treatment period.
11022071|NCT01163149|OG003|Outcome|Asfotase Alfa Combined|Subjects from primary treatment period asfotase alfa groups.
11022072|NCT01163149|EG000|Reported Event|0.3 mg/kg Asfotase Alfa (First 24 Weeks)|Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total)
11022073|NCT01163149|EG001|Reported Event|0.5 mg/kg Asfotase Alfa (First 24 Weeks)|Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total)
11022074|NCT01163149|EG002|Reported Event|Concurrent Control (First 24 Weeks)|"No asfotase alfa treatment during primary treatment period: first 24 weeks.~After 24 weeks, Control Group subjects were eligible to begin asfotase alfa treatment in the open-label extension treatment period."
11022075|NCT01163149|EG003|Reported Event|Cumulative Exposure to Asfotase Alfa|Adverse events occurring in subjects from Cohort 1, Cohort 2 and original Control group during exposure to asfotase alfa.
11022076|NCT01163162|BG000|Baseline|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
11022077|NCT01163162|FG000|Participant Flow|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
11022078|NCT01163162|OG000|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
10886424|NCT00494013|OG000|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
11022079|NCT01163162|EG000|Reported Event|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
11022080|NCT01163214|BG000|Baseline|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
11022081|NCT01163214|BG001|Baseline|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
11022082|NCT01163214|BG002|Baseline|Total|Total of all reporting groups
11022083|NCT01163214|FG000|Participant Flow|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
11022084|NCT01163214|FG001|Participant Flow|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
11022085|NCT01163214|OG000|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
11022086|NCT01163214|OG001|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
11022087|NCT01163214|EG000|Reported Event|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
11022088|NCT01163214|EG001|Reported Event|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
11022089|NCT01163253|BG000|Baseline|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
11022090|NCT01163253|BG001|Baseline|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion.
11022091|NCT01163253|BG002|Baseline|Total|Total of all reporting groups
11022092|NCT01163253|FG000|Participant Flow|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
10886425|NCT00494013|OG001|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
10886426|NCT00494013|EG000|Reported Event|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
10886427|NCT00494013|EG001|Reported Event|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
10886428|NCT00494026|BG000|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
10886429|NCT00494026|FG000|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
10886430|NCT00494026|OG000|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
10886431|NCT00494026|EG000|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
10886432|NCT00494091|BG000|Baseline|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886433|NCT00494091|BG001|Baseline|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886434|NCT00494091|BG002|Baseline|Total|Total of all reporting groups
10886435|NCT00494091|FG000|Participant Flow|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886436|NCT00494091|FG001|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886437|NCT00494091|OG000|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886438|NCT00494091|OG001|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886439|NCT00494091|OG001|Outcome|Temsirolimus 25 mg IV|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886440|NCT00494091|EG000|Reported Event|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886441|NCT00494091|EG001|Reported Event|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
10886442|NCT00494143|BG000|Baseline|CESR, Prescribed, Conventional|all subjects were randomized to each of the three interventions
10886443|NCT00494143|FG000|Participant Flow|Conventional, Prescribed, CESR|this is a randomized arm where the sequence of prosthetic use was their conventional foot, followed by prescribed foot, followed by the CESR foot
10886444|NCT00494143|FG001|Participant Flow|Conventional, CESR, Prescribed|The randomized sequence of prosthetic use in this arm was Conventional foot, followed by CESR foot, followed by Prescribed.
10886445|NCT00494143|FG002|Participant Flow|Prescribed, CESR, Conventional|The randomized sequence of this arm was the Prescribed prosthetic foot, followed by the CESR foot followed by the Conventional prosthetic foot
10886446|NCT00494143|FG003|Participant Flow|Prescribed, Conventional, CESR|This arm included individuals who were randomized to the sequence, Prescribed prosthetic foot, conventional foot, CESR foot
10886447|NCT00494143|FG004|Participant Flow|CESR, Prescribed, Conventional|This arm included the individuals who were randomized to the prosthetic foot sequence, CESR foot followed by Prescribed foot, followed by Conventional foot.
10886448|NCT00494143|FG005|Participant Flow|CESR, Conventional, Prescribed|The individuals in this group were randomized to the prosthetic foot sequence, CESR foot, Conventional foot followed by Prescribed prosthetic foot.
10886449|NCT00494143|OG000|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
10886450|NCT00494143|OG001|Outcome|Conventional Prosthetic Foot|subjects wearing the conventional prosthetic foot
10886451|NCT00494143|OG002|Outcome|Prescribed Prosthetic Foot|subjects wearing the prescribed prosthetic foot
10886452|NCT00494143|OG001|Outcome|Conventional Prosthetic Foot|results with the conventional prosthetic foot
10886453|NCT00494143|OG002|Outcome|Prescribed Prosthetic Foot|results with prescribed prosthetic foot
10886454|NCT00494143|OG001|Outcome|Conventional Prosthetic Foot|results while wearing the conventional prosthetic foot
10886455|NCT00494143|OG002|Outcome|Prescribed Prosthetic Foot|results while wearing the prescribed prosthetic foot
10886456|NCT00494143|EG000|Reported Event|Arm 3 CESR Prosthetic Foot|subjects randomized to the CESR prosthetic foot
10886457|NCT00494143|EG001|Reported Event|Arm 1 Conventional Prosthetic Foot|subjects randomized to the conventional prosthetic foot
10886458|NCT00494143|EG002|Reported Event|Arm 2 Prescribed Prosthetic Foot|subjects randomized to the prescribed prosthetic foot
10886459|NCT00494221|BG000|Baseline|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
10886460|NCT00494221|BG001|Baseline|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
10886461|NCT00494221|BG002|Baseline|Placebo|FOLFOX + Placebo
10886462|NCT00494221|BG003|Baseline|Total|Total of all reporting groups
10886463|NCT00494221|FG000|Participant Flow|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
10886464|NCT00494221|FG001|Participant Flow|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
10886465|NCT00494221|FG002|Participant Flow|Placebo|FOLFOX + Placebo
10886466|NCT00494221|OG000|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
10886467|NCT00494221|OG001|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
10886468|NCT00494221|OG002|Outcome|Placebo|FOLFOX + Placebo
10886469|NCT00494221|EG000|Reported Event|Cediranib 20 mg|Cediranib 20 mg
10886470|NCT00494221|EG001|Reported Event|Cediranib 30 mg|Cediranib 30 mg
10886471|NCT00494221|EG002|Reported Event|Placebo|Placebo
10886472|NCT00494299|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
10886473|NCT00494299|BG001|Baseline|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
10886474|NCT00494299|BG002|Baseline|Total|Total of all reporting groups
10886475|NCT00494299|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
10886476|NCT00494299|FG001|Participant Flow|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
10886477|NCT00494299|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
10886478|NCT00494299|OG001|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
10886479|NCT00494299|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
10886480|NCT00494299|EG001|Reported Event|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
10886481|NCT00494442|BG000|Baseline|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
10886482|NCT00494442|BG001|Baseline|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
10886483|NCT00494442|BG002|Baseline|Total|Total of all reporting groups
10886484|NCT00494442|FG000|Participant Flow|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
10886485|NCT00494442|FG001|Participant Flow|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
10886486|NCT00494442|OG000|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
10886487|NCT00494442|OG001|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
10886488|NCT00494442|EG000|Reported Event|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
10886489|NCT00494442|EG001|Reported Event|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
11225763|NCT02370238|OG001|Outcome|Paclitaxel+Placebo (Group 2)|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
10886490|NCT00494481|BG000|Baseline|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
10886491|NCT00494481|BG001|Baseline|Placebo Plus Docetaxel|placebo plus docetaxel
10886492|NCT00494481|BG002|Baseline|Total|Total of all reporting groups
10886493|NCT00494481|FG000|Participant Flow|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
10886494|NCT00494481|FG001|Participant Flow|Placebo Plus Docetaxel|placebo plus docetaxel
10886495|NCT00494481|OG000|Outcome|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
10886496|NCT00494481|OG001|Outcome|Placebo Plus Docetaxel|placebo plus docetaxel
10886497|NCT00494481|EG000|Reported Event|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
10886498|NCT00494481|EG001|Reported Event|Placebo Plus Docetaxel|placebo plus docetaxel
10886499|NCT00494494|BG000|Baseline|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
10886500|NCT00494494|BG001|Baseline|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
10886501|NCT00494494|BG002|Baseline|Total|Total of all reporting groups
10886502|NCT00494494|FG000|Participant Flow|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
10886503|NCT00494494|FG001|Participant Flow|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
10886504|NCT00494494|OG000|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
10886505|NCT00494494|OG001|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
10886506|NCT00494494|EG000|Reported Event|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
10886507|NCT00494494|EG001|Reported Event|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
10886508|NCT00494507|BG000|Baseline|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886509|NCT00494507|BG001|Baseline|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886510|NCT00494507|BG002|Baseline|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
11022093|NCT01163253|FG001|Participant Flow|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion.
11022094|NCT01163253|OG000|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
11022095|NCT01163253|OG001|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion.
11022096|NCT01163253|EG000|Reported Event|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
11022097|NCT01163253|EG001|Reported Event|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion.
11022098|NCT01163266|BG000|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
11022099|NCT01163266|BG001|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
11022100|NCT01163266|BG002|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
11022101|NCT01163266|BG003|Baseline|Total|Total of all reporting groups
11022102|NCT01163266|FG000|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
11022103|NCT01163266|FG001|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
11022104|NCT01163266|FG002|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
11022105|NCT01163266|OG000|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
11022106|NCT01163266|OG001|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
11022107|NCT01163266|OG002|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
11022108|NCT01163266|EG000|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
11022109|NCT01163266|EG001|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
11022110|NCT01163266|EG002|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
11022111|NCT01163279|BG000|Baseline|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
11022112|NCT01163279|BG001|Baseline|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
11022113|NCT01163279|BG002|Baseline|Total|Total of all reporting groups
11022114|NCT01163279|FG000|Participant Flow|Cogntive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
11022115|NCT01163279|FG001|Participant Flow|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
11225764|NCT02370238|OG000|Outcome|Group 1 - Response Evaluable Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
11341298|NCT03680521|EG001|Reported Event|Sitravatinib 80 mg|Participants received sitravatinib orally, once a day, at a dose of 80 mg for 2 weeks (segment 1). Then, the participants continued to receive sitravatinib in combination with nivolumab 240 mg administered as an intravenous (IV) infusion every 2 weeks, for a maximum of 6 additional weeks (segment 2).
10886511|NCT00494507|BG003|Baseline|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886512|NCT00494507|BG004|Baseline|Total|Total of all reporting groups
10886513|NCT00494507|FG000|Participant Flow|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886514|NCT00494507|FG001|Participant Flow|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886515|NCT00494507|FG002|Participant Flow|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886516|NCT00494507|FG003|Participant Flow|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886517|NCT00494507|OG000|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
10886518|NCT00494507|OG001|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
10886519|NCT00494507|OG000|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
10886520|NCT00494507|OG001|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
10886521|NCT00494507|OG000|Outcome|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886522|NCT00494507|OG001|Outcome|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
10886523|NCT00494507|OG000|Outcome|HOP Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
10886524|NCT00494507|OG001|Outcome|HOP Placebo|Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
10886525|NCT00494507|OG000|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
10886526|NCT00494507|OG001|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
10886527|NCT00494507|OG000|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
10886528|NCT00494507|OG001|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
10886529|NCT00494507|EG000|Reported Event|HYP Double-Blind Dichlorphenamide|Hyperkalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
10886530|NCT00494507|EG001|Reported Event|HYP Double-Blind Placebo|Hyperkalemic participants were randomized to Placebo for the 9 week double-blind phase.
10886531|NCT00494507|EG002|Reported Event|HYP Open-Label Dichlorphenamide|Hyperkalemic participants received Dichlorphenamide for the 52 week open-label phase.
10886532|NCT00494507|EG003|Reported Event|HOP Double-Blind Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
10886533|NCT00494507|EG004|Reported Event|HOP Double-Blind Placebo|Hypokalemic participants were randomized to Placebo for the 9 week double-blind phase.
10886534|NCT00494507|EG005|Reported Event|HOP Open-Label Dichlorphenamide|Hypokalemic participants received Dichlorphenamide for the 52 week open-label phase.
10887263|NCT00499603|BG000|Baseline|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
10887264|NCT00499603|BG001|Baseline|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
10887265|NCT00499603|BG002|Baseline|Total|Total of all reporting groups
11022116|NCT01163279|OG000|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
11022117|NCT01163279|OG001|Outcome|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
11022118|NCT01163279|OG001|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
11022119|NCT01163279|EG000|Reported Event|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
11022120|NCT01163279|EG001|Reported Event|Psychosocial Education|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
11022121|NCT01163292|BG000|Baseline|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
11022122|NCT01163292|BG001|Baseline|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
11022123|NCT01163292|BG002|Baseline|Total|Total of all reporting groups
11022124|NCT01163292|FG000|Participant Flow|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
11022125|NCT01163292|FG001|Participant Flow|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
10849319|NCT00295854|EG001|Reported Event|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
11022126|NCT01163292|OG000|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
11022127|NCT01163292|OG001|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
11022128|NCT01163292|EG000|Reported Event|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
11022129|NCT01163292|EG001|Reported Event|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
11022130|NCT01163318|BG000|Baseline|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
10886535|NCT00494585|BG000|Baseline|CEP-701|80 mg orally twice daily for 30 days
11022131|NCT01163318|FG000|Participant Flow|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
11022132|NCT01163318|OG000|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
11022133|NCT01163318|EG000|Reported Event|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
11022134|NCT01163461|BG000|Baseline|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
11022135|NCT01163461|FG000|Participant Flow|Delayed Aphasia Therapy|14 individuals were randomized to received aphasia therapy following a 6-week control delay phase. Upon completion of the 6-week control phase, they received 60 hours of behavioral therapy
11022136|NCT01163461|FG001|Participant Flow|Immediate Aphasia Therapy|14 individuals were randomized to received 60 hours of aphasia therapy immediately following testing. (no delay)
11022137|NCT01163461|OG000|Outcome|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
11022138|NCT01163461|EG000|Reported Event|Single Group Open Trial|28 individuals were randomized to receive either immediate speech therapy, or delayed speech therapy (following a 6 week delay period to control for Hawthorne effects). All participants received 60 hours of speech therapy 2 hours/day, 5 days/week for 6 weeks. Language behaviors were testing before, after and 3 months later.
11022139|NCT01163474|BG000|Baseline|Arm 1 - Evaluate Video Clinic Visit|Evaluate video clinic visit prior to Face-to-Face usual care visit
11022140|NCT01163474|FG000|Participant Flow|Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua|Evaluate video clinic visit prior to Face-to-Face usual care visit
11022141|NCT01163474|OG000|Outcome|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
11022142|NCT01163474|OG000|Outcome|Arm 1 - Provider Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
11022143|NCT01163474|OG000|Outcome|Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua|Evaluate video clinic visit prior to Face-to-Face usual care visit
11022144|NCT01163474|EG000|Reported Event|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
11022145|NCT01163474|EG001|Reported Event|Arm 2|Face-to-face follow up for subjects (control)
11022146|NCT01163604|BG000|Baseline|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
11022147|NCT01163604|BG001|Baseline|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
10886536|NCT00494585|FG000|Participant Flow|CEP-701|80 mg orally twice daily for 30 days
11022148|NCT01163604|BG002|Baseline|Total|Total of all reporting groups
11022149|NCT01163604|FG000|Participant Flow|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
11022150|NCT01163604|FG001|Participant Flow|"Aspirin and Clopidogrel Interventions Group"|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
11022151|NCT01163604|OG000|Outcome|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
11022152|NCT01163604|OG001|Outcome|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
11022153|NCT01163604|EG000|Reported Event|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
11022154|NCT01163604|EG001|Reported Event|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
11022155|NCT01163617|BG000|Baseline|All Study Participants|Includes participants from Phases A and B of the study
11022156|NCT01163617|FG000|Participant Flow|Current Syringe First, Then Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
11022157|NCT01163617|FG001|Participant Flow|Physiolis Syringe First, Then Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
11022158|NCT01163617|FG002|Participant Flow|Current Autoinjector First, Then Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
11022159|NCT01163617|FG003|Participant Flow|Physiolis Autoinjector First, Then Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
11022160|NCT01163617|FG004|Participant Flow|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
10886537|NCT00494585|OG000|Outcome|CEP-701|80 mg orally twice daily for 30 days
10886538|NCT00494585|EG000|Reported Event|CEP-701|80 mg orally twice daily for 30 days
11022161|NCT01163617|FG005|Participant Flow|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
11022162|NCT01163617|FG006|Participant Flow|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
11022163|NCT01163617|FG007|Participant Flow|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
11022164|NCT01163617|OG000|Outcome|Current/Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
11341299|NCT03680742|BG000|Baseline|Treated|"All eligible patients who underwent an attempt with the Contour device.~Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms."
10886539|NCT00494676|BG000|Baseline|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
11022165|NCT01163617|OG001|Outcome|Physiolis/Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
11022166|NCT01163617|OG002|Outcome|Current/Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
11022167|NCT01163617|OG003|Outcome|Physiolis/Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
11022168|NCT01163617|OG000|Outcome|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C)
11022169|NCT01163617|OG001|Outcome|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C)
11022170|NCT01163617|OG000|Outcome|Current Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
11022171|NCT01163617|OG001|Outcome|Physiolis Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
11022172|NCT01163617|OG000|Outcome|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C)
11022173|NCT01163617|OG001|Outcome|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C)
11022174|NCT01163617|EG000|Reported Event|Current Syringe|Self-injection using current syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
10886540|NCT00494676|FG000|Participant Flow|Real Prism Glasses Then Sham|Real prism glasses for 4 weeks followed by sham prism glasses for 4 weeks
11022175|NCT01163617|EG001|Reported Event|Physiolis Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
11022176|NCT01163617|EG002|Reported Event|Current Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
11022177|NCT01163617|EG003|Reported Event|Physiolis Autoinjector|Self-injection using Physiolis autoinjector at Week 0 or Week 2 (Visit 2) (Phase A)
11022178|NCT01163617|EG004|Reported Event|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
11022179|NCT01163617|EG005|Reported Event|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
11022180|NCT01163617|EG006|Reported Event|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
11022181|NCT01163617|EG007|Reported Event|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
11022182|NCT01163643|BG000|Baseline|2% BOL-303242-X Ophthalmic Suspension|"2% BOL-303242-X ophthalmic suspension~2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022183|NCT01163643|BG001|Baseline|2% BOL-303242-X Ophthalmic Suspension in the Morning|"2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)~2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks."
11022184|NCT01163643|BG002|Baseline|2% BOL-303242-X Ophthalmic Suspension PM|"Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.~2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks."
11022185|NCT01163643|BG003|Baseline|1% BOL-303242-X Ophthalmic Suspension|"1% BOL-303242-X ophthalmic suspension~1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022186|NCT01163643|BG004|Baseline|0.3% BOL-303242-X Ophthalmic Suspension|"0.3% BOL-303242-X ophthalmic suspension~0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022187|NCT01163643|BG005|Baseline|Vehicle|"Vehicle twice daily (BID)~Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks."
11022188|NCT01163643|BG006|Baseline|Total|Total of all reporting groups
11022189|NCT01163643|FG000|Participant Flow|2% BOL-303242-X Ophthalmic Suspension|"2% BOL-303242-X ophthalmic suspension~2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks."
10886541|NCT00494676|FG001|Participant Flow|Sham Prism Glasses Then Real|Sham prism glasses for 4 weeks followed by real prism glasses for 4 weeks
11022190|NCT01163643|FG001|Participant Flow|2% BOL-303242-X Ophthalmic Suspension in the Morning|"2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)~2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks."
11022191|NCT01163643|FG002|Participant Flow|2% BOL-303242-X Ophthalmic Suspension PM|"Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.~2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks."
11022192|NCT01163643|FG003|Participant Flow|1% BOL-303242-X Ophthalmic Suspension|"1% BOL-303242-X ophthalmic suspension~1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022193|NCT01163643|FG004|Participant Flow|0.3% BOL-303242-X Ophthalmic Suspension|"0.3% BOL-303242-X ophthalmic suspension~0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022194|NCT01163643|FG005|Participant Flow|Vehicle|"Vehicle twice daily (BID)~Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks."
11022195|NCT01163643|OG000|Outcome|2% BOL-303242-X Ophthalmic Suspension|"2% BOL-303242-X ophthalmic suspension~2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11341300|NCT03680742|FG000|Participant Flow|Treated|"All eligible patients who underwent an attempt with the Contour device.~Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms."
10886542|NCT00494676|OG000|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
11022196|NCT01163643|OG001|Outcome|2% BOL-303242-X Ophthalmic Suspension in the Morning|"2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)~2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks."
11022197|NCT01163643|OG002|Outcome|2% BOL-303242-X Ophthalmic Suspension PM|"Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.~2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks."
11022198|NCT01163643|OG003|Outcome|1% BOL-303242-X Ophthalmic Suspension|"1% BOL-303242-X ophthalmic suspension~1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022199|NCT01163643|OG004|Outcome|0.3% BOL-303242-X Ophthalmic Suspension|"0.3% BOL-303242-X ophthalmic suspension~0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022200|NCT01163643|OG005|Outcome|Vehicle|"Vehicle twice daily (BID)~Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks."
11022201|NCT01163643|EG000|Reported Event|2% BOL-303242-X Ophthalmic Suspension|"2% BOL-303242-X ophthalmic suspension~2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022202|NCT01163643|EG001|Reported Event|2% BOL-303242-X Ophthalmic Suspension in the Morning|"2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)~2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks."
11022203|NCT01163643|EG002|Reported Event|2% BOL-303242-X Ophthalmic Suspension PM|"Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.~2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks."
11022204|NCT01163643|EG003|Reported Event|1% BOL-303242-X Ophthalmic Suspension|"1% BOL-303242-X ophthalmic suspension~1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022205|NCT01163643|EG004|Reported Event|0.3% BOL-303242-X Ophthalmic Suspension|"0.3% BOL-303242-X ophthalmic suspension~0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks."
11022206|NCT01163643|EG005|Reported Event|Vehicle|"Vehicle twice daily (BID)~Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks."
11022207|NCT01163656|BG000|Baseline|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
11022208|NCT01163656|BG001|Baseline|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
11022209|NCT01163656|BG002|Baseline|Total|Total of all reporting groups
11022210|NCT01163656|FG000|Participant Flow|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
11022211|NCT01163656|FG001|Participant Flow|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
11022212|NCT01163656|OG000|Outcome|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
11022213|NCT01163656|OG001|Outcome|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
11022214|NCT01163656|EG000|Reported Event|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
11022215|NCT01163656|EG001|Reported Event|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
11022216|NCT01163721|BG000|Baseline|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
11022217|NCT01163721|BG001|Baseline|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
11022218|NCT01163721|BG002|Baseline|Total|Total of all reporting groups
11022219|NCT01163721|FG000|Participant Flow|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
11022220|NCT01163721|FG001|Participant Flow|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
11022221|NCT01163721|OG000|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
11022222|NCT01163721|OG001|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
11022223|NCT01163721|EG000|Reported Event|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
11022224|NCT01163721|EG001|Reported Event|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
11022225|NCT01163747|BG000|Baseline|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
11022226|NCT01163747|BG001|Baseline|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
11022227|NCT01163747|BG002|Baseline|Total|Total of all reporting groups
11022228|NCT01163747|FG000|Participant Flow|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
11022229|NCT01163747|FG001|Participant Flow|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
11022230|NCT01163747|OG000|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
11022231|NCT01163747|OG001|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
11022232|NCT01163747|EG000|Reported Event|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
11022233|NCT01163747|EG001|Reported Event|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
11022234|NCT01163760|BG000|Baseline|Overall|Total number of completed participants are included in baseline measurements.
11022235|NCT01163760|FG000|Participant Flow|Etafilcon A First, Then Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
11022236|NCT01163760|FG001|Participant Flow|Ocufilcon D First, Then Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
11022237|NCT01163760|FG002|Participant Flow|Etafilcon A First, Then Etafilcon A|etafilcon A contact lenses worn for both periods.
11022238|NCT01163760|FG003|Participant Flow|Ocufilcon D First, Then Ocufilcon D|Ocufilcon D contact lenses worn for both periods.
10886543|NCT00494676|OG000|Outcome|Entire Study Population Who Continued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
11022239|NCT01163760|OG000|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
11022240|NCT01163760|OG001|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
11022241|NCT01163760|EG000|Reported Event|Etafilcon A/ Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
11022242|NCT01163760|EG001|Reported Event|Ocufilcon D / Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
11022243|NCT01163760|EG002|Reported Event|Etafilcon A/ Etafilcon A|etafilcon A contact lenses worn first and second period.
11022244|NCT01163760|EG003|Reported Event|Oculfilcon D / Ocufilcon D|ocufilcon D contact lenses worn first and second period.
11022245|NCT01163786|BG000|Baseline|Bortezomib|"Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.~Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle."
11022246|NCT01163786|FG000|Participant Flow|Bortezomib|"Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.~Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle."
11022247|NCT01163786|OG000|Outcome|Bortezomib|"Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.~Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle."
11022248|NCT01163786|EG000|Reported Event|Bortezomib|"Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.~Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle."
11022249|NCT01163851|BG000|Baseline|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
11022250|NCT01163851|BG001|Baseline|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
11022251|NCT01163851|BG002|Baseline|Total|Total of all reporting groups
10886544|NCT00494676|OG000|Outcome|Entire Study Population Who Discontinued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
11022252|NCT01163851|FG000|Participant Flow|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
11022253|NCT01163851|FG001|Participant Flow|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
11022254|NCT01163851|OG000|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
11022255|NCT01163851|OG001|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
11225765|NCT02370238|OG001|Outcome|Group 2 - Response-Evaluable Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
11022256|NCT01163851|EG000|Reported Event|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
11022257|NCT01163851|EG001|Reported Event|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
11022258|NCT01163916|BG000|Baseline|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
11022259|NCT01163916|BG001|Baseline|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
11022260|NCT01163916|BG002|Baseline|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
11022261|NCT01163916|BG003|Baseline|Total|Total of all reporting groups
11022262|NCT01163916|FG000|Participant Flow|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
11022263|NCT01163916|FG001|Participant Flow|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
11022264|NCT01163916|FG002|Participant Flow|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
11022265|NCT01163916|OG000|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.
11022266|NCT01163916|OG001|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
11022267|NCT01163916|OG002|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
11022268|NCT01163916|OG000|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
11022269|NCT01163916|OG000|Outcome|Convenient|"Participants who described the acceptability of adalimumab injections as convenient."
11022270|NCT01163916|OG001|Outcome|Not Convenient|"Participants who described the acceptability of adalimumab injections as not convenient."
11022271|NCT01163916|OG002|Outcome|Need Assistance|Participants who were unable to self-inject.
11022272|NCT01163916|OG003|Outcome|Missing|Participants for whom acceptability data were not available.
11022273|NCT01163916|EG000|Reported Event|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
11022274|NCT01163916|EG001|Reported Event|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
11022275|NCT01163916|EG002|Reported Event|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
11022276|NCT01163955|BG000|Baseline|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
11022277|NCT01163955|BG001|Baseline|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
11022278|NCT01163955|BG002|Baseline|Total|Total of all reporting groups
11022279|NCT01163955|FG000|Participant Flow|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
11022280|NCT01163955|FG001|Participant Flow|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
11022281|NCT01163955|OG000|Outcome|Postural Score Sitting on Floor After 5 Minutes|Children sat on the floor for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
11022282|NCT01163955|OG001|Outcome|Postural Score Sitting in a Chair After 5 Minutes|Children sat in a chair for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
11341301|NCT03680742|OG000|Outcome|Treated|"All eligible patients who underwent an attempt with the Contour device.~Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms."
11022283|NCT01163955|EG000|Reported Event|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
11022284|NCT01163955|EG001|Reported Event|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
11022285|NCT01164007|BG000|Baseline|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
11022286|NCT01164007|FG000|Participant Flow|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Day 1 and bevacizumab as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
11022287|NCT01164007|OG000|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
11022288|NCT01164007|EG000|Reported Event|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
11022289|NCT01164098|BG000|Baseline|Rituximab|"Participants will receive Rituximab post within 24 of Kidney Transplant~Rituximab: Induction therapy"
11022290|NCT01164098|BG001|Baseline|No Rituximab|Participants will not receive Rituximab within 24 hours of Kidney Transplant
11022291|NCT01164098|BG002|Baseline|Total|Total of all reporting groups
11022292|NCT01164098|FG000|Participant Flow|Rituximab|"Participants will receive Rituximab post within 24 of Kidney Transplant~Rituximab: Induction therapy"
11022293|NCT01164098|FG001|Participant Flow|No Rituximab|Participants will not receive Rituximab within 24 hours of Kidney Transplant
11022294|NCT01164098|OG000|Outcome|Rituximab|"Participants will receive Rituximab post within 24 of Kidney Transplant~Rituximab: Induction therapy"
11022295|NCT01164098|OG001|Outcome|No Rituximab|Participants will not receive Rituximab within 24 hours of Kidney Transplant
11022296|NCT01164098|EG000|Reported Event|Rituximab|"Participants will receive Rituximab post within 24 of Kidney Transplant~Rituximab: Induction therapy"
11022297|NCT01164098|EG001|Reported Event|No Rituximab|Participants will not receive Rituximab within 24 hours of Kidney Transplant
11022298|NCT01164137|BG000|Baseline|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
11022299|NCT01164137|BG001|Baseline|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
11225766|NCT02370238|OG000|Outcome|Paclitaxel+Reparixin (Group 1) - Safety Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
10886545|NCT00494676|EG000|Reported Event|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
11022300|NCT01164137|BG002|Baseline|Total|Total of all reporting groups
11022301|NCT01164137|FG000|Participant Flow|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
11022302|NCT01164137|FG001|Participant Flow|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
11022303|NCT01164137|OG000|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
11022304|NCT01164137|OG001|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
11022305|NCT01164137|EG000|Reported Event|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
11022306|NCT01164137|EG001|Reported Event|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
11022307|NCT01164475|BG000|Baseline|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
11022308|NCT01164475|BG001|Baseline|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
11022309|NCT01164475|BG002|Baseline|Total|Total of all reporting groups
11022310|NCT01164475|FG000|Participant Flow|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to [>=] 5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
11022311|NCT01164475|FG001|Participant Flow|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
11341302|NCT03680742|EG000|Reported Event|Treated|"All eligible patients who underwent an attempt with the Contour device.~Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms."
10886546|NCT00494780|BG000|Baseline|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886547|NCT00494780|BG001|Baseline|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886548|NCT00494780|BG002|Baseline|Total|Total of all reporting groups
10886549|NCT00494780|FG000|Participant Flow|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886550|NCT00494780|FG001|Participant Flow|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886551|NCT00494780|OG000|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886552|NCT00494780|OG001|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886553|NCT00494780|EG000|Reported Event|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886554|NCT00494780|EG001|Reported Event|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886555|NCT00494780|EG002|Reported Event|500 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886556|NCT00494780|EG003|Reported Event|1000 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
10886557|NCT00494806|BG000|Baseline|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
10886558|NCT00494806|BG001|Baseline|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
10886559|NCT00494806|BG002|Baseline|Total|Total of all reporting groups
10886560|NCT00494806|FG000|Participant Flow|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
10886561|NCT00494806|FG001|Participant Flow|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
10886562|NCT00494806|OG000|Outcome|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
10886563|NCT00494806|OG001|Outcome|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
10886564|NCT00494806|EG000|Reported Event|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
10886565|NCT00494806|EG001|Reported Event|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
11148709|NCT01866410|FG000|Participant Flow|Cabozantinib-s-malate, Erlotinib Hydrochloride|"Patients will receive (A) XL184 (cabozantinib) at 40-mg p.o. daily plus erlotinib at 150-mg p.o. daily in 4-week cycles. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Erlotinib Hydrochloride: Given PO"
11148710|NCT01866410|OG000|Outcome|Cabozantinib-s-malate, Erlotinib Hydrochloride|"Patients will receive (A) XL184 (cabozantinib) at 40-mg p.o. daily plus erlotinib at 150-mg p.o. daily in 4-week cycles. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Erlotinib Hydrochloride: Given PO"
10886566|NCT00494871|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
10886567|NCT00494871|BG001|Baseline|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
10886568|NCT00494871|BG002|Baseline|Total|Total of all reporting groups
10886569|NCT00494871|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
10886570|NCT00494871|FG001|Participant Flow|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
10886571|NCT00494871|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
10886572|NCT00494871|OG001|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
10886573|NCT00494871|EG000|Reported Event|RG1: Rivaroxaban Double-blind (DB) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
10886574|NCT00494871|EG001|Reported Event|RG2: Warfarin DB Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
11341303|NCT03681093|BG000|Baseline|Fevipiprant 150 mg|Fevipiprant (QAW039) 150 mg once daily orally
10886575|NCT00494871|EG002|Reported Event|RG3: Rivaroxaban Follow-up (FU) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
10886576|NCT00494871|EG003|Reported Event|RG4: Warfarin FU Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
10886577|NCT00494975|BG000|Baseline|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
10886578|NCT00494975|BG001|Baseline|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
10886579|NCT00494975|BG002|Baseline|Total|Total of all reporting groups
10886580|NCT00494975|FG000|Participant Flow|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
10886581|NCT00494975|FG001|Participant Flow|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
10886582|NCT00494975|OG000|Outcome|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
10886583|NCT00494975|OG001|Outcome|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
10886584|NCT00494975|EG000|Reported Event|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
10886585|NCT00494975|EG001|Reported Event|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
10886586|NCT00495040|BG000|Baseline|Dose-escalated Proton Therapy for Early-stage Non-small Cell l|35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
10886587|NCT00495040|FG000|Participant Flow|Dose-escalated Proton Therapy for Early-stage NSCLC|35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
10886588|NCT00495040|OG000|Outcome|Dose-escalated Proton Therapy for Early-stage Non-small Cell l|35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
10886589|NCT00495040|EG000|Reported Event|Dose-escalated Proton Therapy for Early-stage Non-small Cell l|35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
10886590|NCT00495079|BG000|Baseline|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
10886591|NCT00495079|FG000|Participant Flow|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
10886592|NCT00495079|OG000|Outcome|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
10886593|NCT00495079|OG000|Outcome|Marqibo|"Duration of response derived using the IRRC determined response dates for subjects who achieved CR or CRi (n=8). The K-M product limit method was used to estimate the median event time.~Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+- 10 minutes)every 7 days (+/- 3 days)"
11341304|NCT03681093|BG001|Baseline|Fevipiprant 450 mg|Fevipiprant (QAW039) 450 mg once daily orally
11341305|NCT03681093|BG002|Baseline|Placebo|Placebo once daily orally
11341306|NCT03681093|BG003|Baseline|Total|Total of all reporting groups
11022312|NCT01164475|OG000|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
11022313|NCT01164475|OG001|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
11022314|NCT01164475|EG000|Reported Event|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
11022315|NCT01164475|EG001|Reported Event|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
11066221|NCT01391130|OG000|Outcome|LY2510924 + Sunitinib|LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
11066222|NCT01391130|OG001|Outcome|Sunitinib|50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
11066223|NCT01391130|EG000|Reported Event|LY2510924 + Sunitinib|LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
11066224|NCT01391130|EG001|Reported Event|Sunitinib|50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
11066225|NCT01391273|BG000|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
10886594|NCT00495079|OG000|Outcome|Marqibo|"The population analyzed included all subjects who received at least one dose of Marqibo. Subjects who did not die had their survival times censored on the date of last contact. The K-M method was used to estimate the distribution of overall survival.~Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes)every 7 days (+/- 3 days)"
11066226|NCT01391273|BG001|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
11066227|NCT01391273|BG002|Baseline|Total|Total of all reporting groups
11066228|NCT01391273|FG000|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
11066229|NCT01391273|FG001|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
11066230|NCT01391273|OG000|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
11066231|NCT01391273|OG001|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
11066232|NCT01391273|EG000|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
11066233|NCT01391273|EG001|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
11066234|NCT01391286|BG000|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
11066235|NCT01391286|BG001|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
11066236|NCT01391286|BG002|Baseline|Total|Total of all reporting groups
11066237|NCT01391286|FG000|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
11066238|NCT01391286|FG001|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
11066239|NCT01391286|OG000|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
11341307|NCT03681093|FG000|Participant Flow|Fevipiprant 150 mg|Fevipiprant (QAW039) 150 mg once daily orally
11022316|NCT01164501|BG000|Baseline|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
11022317|NCT01164501|BG001|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
11022318|NCT01164501|BG002|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
11022319|NCT01164501|BG003|Baseline|Total|Total of all reporting groups
11022320|NCT01164501|FG000|Participant Flow|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
11022321|NCT01164501|FG001|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
11022322|NCT01164501|FG002|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
11022323|NCT01164501|OG000|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
11022324|NCT01164501|OG001|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
11022325|NCT01164501|OG001|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
11022326|NCT01164501|OG002|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
11022327|NCT01164501|OG000|Outcome|Placebo|Placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
11022328|NCT01164501|EG000|Reported Event|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
11022329|NCT01164501|EG001|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
11022330|NCT01164501|EG002|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
11022331|NCT01164579|BG000|Baseline|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022332|NCT01164579|BG001|Baseline|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022333|NCT01164579|BG002|Baseline|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
10886595|NCT00495079|OG000|Outcome|Marqibo|"Proportion if subjects who achieved CR+CRi as determined by the IRRC using the International Working Group (IWG)Criteria. The IRRC Evaluable analysis set(n=53) included subjects who received at least 1 dose of study drug and reviewable data.~Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+/-10 minutes) every 7 days (+/-3days)"
11022334|NCT01164579|BG003|Baseline|Total|Total of all reporting groups
11022335|NCT01164579|FG000|Participant Flow|Tofacitinib (CP-690,550) Plus Methotrexate (MTX)|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022336|NCT01164579|FG001|Participant Flow|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11066240|NCT01391286|OG001|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
11066241|NCT01391286|EG000|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
10886596|NCT00495079|EG000|Reported Event|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
11022337|NCT01164579|FG002|Participant Flow|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022338|NCT01164579|OG000|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022339|NCT01164579|OG001|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022340|NCT01164579|OG002|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022341|NCT01164579|OG000|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022342|NCT01164579|EG000|Reported Event|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022343|NCT01164579|EG001|Reported Event|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022344|NCT01164579|EG002|Reported Event|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
11022345|NCT01164644|BG000|Baseline|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
11022346|NCT01164644|BG001|Baseline|Placebo|The subject will take twelve pills by mouth three times a day over four days.
11022347|NCT01164644|BG002|Baseline|Total|Total of all reporting groups
11022348|NCT01164644|FG000|Participant Flow|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
10886597|NCT00495157|BG000|Baseline|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
11022349|NCT01164644|FG001|Participant Flow|Placebo|The subject will take twelve pills by mouth three times a day over four days.
11022350|NCT01164644|OG000|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
11022351|NCT01164644|OG001|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
11022352|NCT01164644|EG000|Reported Event|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
11022353|NCT01164644|EG001|Reported Event|Placebo|The subject will take twelve pills by mouth three times a day over four days.
11022354|NCT01164722|BG000|Baseline|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
11022355|NCT01164722|BG001|Baseline|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
11022356|NCT01164722|BG002|Baseline|Total|Total of all reporting groups
11022357|NCT01164722|FG000|Participant Flow|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
11022358|NCT01164722|FG001|Participant Flow|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
11022359|NCT01164722|OG000|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
11022360|NCT01164722|OG001|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
11022361|NCT01164722|EG000|Reported Event|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
11022362|NCT01164722|EG001|Reported Event|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
11022363|NCT01164865|BG000|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
11022364|NCT01164865|BG001|Baseline|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
11022365|NCT01164865|BG002|Baseline|Total|Total of all reporting groups
11022366|NCT01164865|FG000|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
11022367|NCT01164865|FG001|Participant Flow|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
11022368|NCT01164865|OG000|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
11022369|NCT01164865|OG001|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
11022370|NCT01164865|EG000|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
11022371|NCT01164865|EG001|Reported Event|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
11022372|NCT01164891|BG000|Baseline|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
11022373|NCT01164891|FG000|Participant Flow|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 milligrams (mg) orally two times daily (BID) from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
11022374|NCT01164891|OG000|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
11022375|NCT01164891|OG000|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15 participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
11022376|NCT01164891|EG000|Reported Event|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
11066242|NCT01391286|EG001|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
11066243|NCT01391299|BG000|Baseline|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
11022377|NCT01164956|BG000|Baseline|All Participants|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022378|NCT01164956|FG000|Participant Flow|M-P, P-M, M-P|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022379|NCT01164956|FG001|Participant Flow|P-M, P-M, M-P|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022380|NCT01164956|FG002|Participant Flow|P-M, M-P, M-P|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022381|NCT01164956|OG000|Outcome|All Participants|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022382|NCT01164956|OG000|Outcome|M-P, P-M, M-P|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022383|NCT01164956|OG001|Outcome|P-M, P-M, M-P|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022384|NCT01164956|OG002|Outcome|P-M, M-P, M-P|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022385|NCT01164956|OG000|Outcome|P-M, P-M, M-P|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022386|NCT01164956|EG000|Reported Event|All Participants|Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
11022387|NCT01165021|BG000|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
11022388|NCT01165021|FG000|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
11022389|NCT01165021|OG000|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
11022390|NCT01165021|EG000|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
11022391|NCT01165047|BG000|Baseline|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
11066244|NCT01391299|BG001|Baseline|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
11225767|NCT02370238|OG001|Outcome|Paclitaxel+Placebo (Group 2) - Safety Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
10849753|NCT00298038|BG001|Baseline|Placebo|Participants were administered a single matching placebo tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
11022392|NCT01165047|FG000|Participant Flow|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
11022393|NCT01165047|OG000|Outcome|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
11022394|NCT01165047|EG000|Reported Event|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
11022395|NCT01165112|BG000|Baseline|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11022396|NCT01165112|FG000|Participant Flow|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11022397|NCT01165112|OG000|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11022398|NCT01165112|EG000|Reported Event|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11022399|NCT01165138|BG000|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022400|NCT01165138|BG001|Baseline|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022401|NCT01165138|BG002|Baseline|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
10886598|NCT00495157|BG001|Baseline|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
11022402|NCT01165138|BG003|Baseline|Total|Total of all reporting groups
11022403|NCT01165138|FG000|Participant Flow|Current Anti-asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) for 4 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
11022404|NCT01165138|FG001|Participant Flow|Placebo|Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022405|NCT01165138|FG002|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022406|NCT01165138|FG003|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022407|NCT01165138|OG000|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022408|NCT01165138|OG001|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11066245|NCT01391299|BG002|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
11341308|NCT03681093|FG001|Participant Flow|Fevipiprant 450 mg|Fevipiprant (QAW039) 450 mg once daily orally
11341309|NCT03681093|FG002|Participant Flow|Placebo|Placebo once daily orally
11341310|NCT03681093|OG000|Outcome|Fevipiprant 150 mg|Fevipiprant (QAW039) 150 mg once daily orally
10886599|NCT00495157|BG002|Baseline|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
10886600|NCT00495157|BG003|Baseline|Total|Total of all reporting groups
11022409|NCT01165138|OG002|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022410|NCT01165138|EG000|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022411|NCT01165138|EG001|Reported Event|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022412|NCT01165138|EG002|Reported Event|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11022413|NCT01165177|BG000|Baseline|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
11022414|NCT01165177|BG001|Baseline|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022415|NCT01165177|BG002|Baseline|Total|Total of all reporting groups
11022416|NCT01165177|FG000|Participant Flow|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
11022417|NCT01165177|FG001|Participant Flow|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022418|NCT01165177|OG000|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
11225768|NCT02370238|EG000|Reported Event|Paclitaxel+Reparixin (Group 1) - Safety Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
11022419|NCT01165177|OG001|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
11022420|NCT01165177|OG002|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
11022421|NCT01165177|OG003|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
11022422|NCT01165177|OG004|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
11022423|NCT01165177|OG005|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
11022424|NCT01165177|OG006|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
11022425|NCT01165177|OG007|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
10849754|NCT00298038|BG002|Baseline|Total|Total of all reporting groups
11022426|NCT01165177|OG000|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
11022427|NCT01165177|OG001|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022428|NCT01165177|EG000|Reported Event|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
11022429|NCT01165177|EG001|Reported Event|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022430|NCT01165203|BG000|Baseline|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022431|NCT01165203|BG001|Baseline|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022432|NCT01165203|BG002|Baseline|Total|Total of all reporting groups
11022433|NCT01165203|FG000|Participant Flow|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022434|NCT01165203|FG001|Participant Flow|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022435|NCT01165203|OG000|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022436|NCT01165203|OG001|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022437|NCT01165203|OG000|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022438|NCT01165203|OG000|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022439|NCT01165203|OG001|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022440|NCT01165203|OG002|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11341311|NCT03681093|OG001|Outcome|Fevipiprant 450 mg|Fevipiprant (QAW039) 450 mg once daily orally
11341312|NCT03681093|OG002|Outcome|Placebo|Placebo once daily orally
11225769|NCT02370238|EG001|Reported Event|Paclitaxel+Placebo (Group 2) - Safety Population|"paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.~Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first."
11022441|NCT01165203|OG003|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022442|NCT01165203|OG004|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022443|NCT01165203|OG005|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022444|NCT01165203|EG000|Reported Event|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022445|NCT01165203|EG001|Reported Event|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11022446|NCT01165216|BG000|Baseline|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11022447|NCT01165216|BG001|Baseline|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11022448|NCT01165216|BG002|Baseline|Total|Total of all reporting groups
11225770|NCT02370251|BG000|Baseline|Omegaven|"Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.~Omegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs."
11022449|NCT01165216|FG000|Participant Flow|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11225771|NCT02370251|FG000|Participant Flow|Omegaven|Omegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day.
11225772|NCT02370251|OG000|Outcome|Omegaven|"Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.~Omegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs."
11225773|NCT02370251|EG000|Reported Event|Omegaven|"Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.~Omegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs."
11022450|NCT01165216|FG001|Participant Flow|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11022451|NCT01165216|OG000|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11022452|NCT01165216|OG001|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11022453|NCT01165216|OG001|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11022454|NCT01165216|OG001|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30 -60 minutes every 3 weeks (up to 6 doses).
11022455|NCT01165216|EG000|Reported Event|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11066246|NCT01391299|BG003|Baseline|Total|Total of all reporting groups
11066247|NCT01391299|FG000|Participant Flow|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
11022456|NCT01165216|EG001|Reported Event|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
11022457|NCT01165229|BG000|Baseline|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022458|NCT01165229|BG001|Baseline|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022459|NCT01165229|BG002|Baseline|Total|Total of all reporting groups
11022460|NCT01165229|FG000|Participant Flow|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022461|NCT01165229|FG001|Participant Flow|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022462|NCT01165229|OG000|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022463|NCT01165229|OG001|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022464|NCT01165229|OG002|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022465|NCT01165229|OG003|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022466|NCT01165229|OG004|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11225774|NCT02370368|BG000|Baseline|Dance Training|Dance training with the XBOX Kinect 3 times per week for six weeks.
11022467|NCT01165229|OG005|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022468|NCT01165229|OG000|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022469|NCT01165229|OG001|Outcome|Zoster-022/006 Pooled GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022470|NCT01165229|OG002|Outcome|Zoster-022/006 Pooled GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022471|NCT01165229|OG003|Outcome|Zoster-022/006 Pooled Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022472|NCT01165229|OG004|Outcome|Zoster-022/006 Pooled Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022473|NCT01165229|OG005|Outcome|Zoster-022/006 Pooled Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022474|NCT01165229|OG000|Outcome|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022475|NCT01165229|OG001|Outcome|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022476|NCT01165229|OG000|Outcome|Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group|Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022477|NCT01165229|OG001|Outcome|Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group|Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022478|NCT01165229|OG002|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022479|NCT01165229|OG003|Outcome|Zoster-022/006 Pooled GSK1437173A >=80 YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022480|NCT01165229|OG004|Outcome|Zoster-022/006 Pooled GSK1437173A >=50 YOA Group|Subjects above 50 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022481|NCT01165229|OG005|Outcome|Zoster-022/006 Pooled Placebo 50-59 YOA Group|Subjects between 50 and 59 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022482|NCT01165229|OG006|Outcome|Zoster-022/006 Pooled Placebo 60-69 YOA Group|Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022483|NCT01165229|OG007|Outcome|Zoster-022/006 Pooled Placebo 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022484|NCT01165229|OG008|Outcome|Zoster-022/006 Pooled Placebo >=80 YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022485|NCT01165229|OG009|Outcome|Zoster-022/006 Pooled Placebo >=50 YOA Group|Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11225775|NCT02370368|BG001|Baseline|Ladder Drills|Agility ladder drills 3 times per week for six weeks
11225776|NCT02370368|BG002|Baseline|Total|Total of all reporting groups
11225777|NCT02370368|FG000|Participant Flow|Dance Training|Participated in dance training with the XBOX Kinect 3 days per week for six weeks.
11225778|NCT02370368|FG001|Participant Flow|Ladder Drills|Participated in a ladder drill training programme three times per week for six weeks.
11225779|NCT02370368|OG000|Outcome|Dance Training|Participated in dance training with the XBOX Kinect 3 days per week for six weeks.
11225780|NCT02370368|OG001|Outcome|Ladder Drills|Participated in a ladder drill training programme three times per week for six weeks.
11022486|NCT01165229|OG000|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022487|NCT01165229|OG001|Outcome|Zoster-022/006 Pooled GSK1437173A >=80 YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022488|NCT01165229|OG002|Outcome|Zoster-022/006 Pooled GSK1437173A >=70 YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022489|NCT01165229|OG003|Outcome|Zoster-022/006 Pooled Placebo 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022490|NCT01165229|OG004|Outcome|Zoster-022/006 Pooled Placebo >=80 YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022491|NCT01165229|OG005|Outcome|Zoster-022/006 Pooled Placebo >=70 YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022492|NCT01165229|OG000|Outcome|Zoster-022/006 Pooled GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022493|NCT01165229|OG001|Outcome|Zoster-022/006 Pooled Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11225781|NCT02370368|EG000|Reported Event|Dance Training|Participated in dance training with the XBOX Kinect 3 days per week for six weeks.
11225782|NCT02370368|EG001|Reported Event|Ladder Drills|Participated in a ladder drill training programme three times per week for six weeks.
10886601|NCT00495157|FG000|Participant Flow|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
10886602|NCT00495157|FG001|Participant Flow|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
10886603|NCT00495157|FG002|Participant Flow|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
11022494|NCT01165229|EG000|Reported Event|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
11022495|NCT01165229|EG001|Reported Event|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
11022496|NCT01165242|BG000|Baseline|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022497|NCT01165242|BG001|Baseline|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022498|NCT01165242|BG002|Baseline|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022499|NCT01165242|BG003|Baseline|Total|Total of all reporting groups
11022500|NCT01165242|FG000|Participant Flow|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022501|NCT01165242|FG001|Participant Flow|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022502|NCT01165242|FG002|Participant Flow|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022503|NCT01165242|OG000|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022504|NCT01165242|OG001|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022505|NCT01165242|OG001|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022506|NCT01165242|OG002|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022507|NCT01165242|OG000|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022508|NCT01165242|EG000|Reported Event|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022509|NCT01165242|EG001|Reported Event|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11022510|NCT01165242|EG002|Reported Event|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
11066248|NCT01391299|FG001|Participant Flow|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
11066249|NCT01391299|FG002|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
11341313|NCT03681093|EG000|Reported Event|Fevipiprant 150 mg|Fevipiprant (QAW039) 150 mg once daily orally
11022511|NCT01165281|BG000|Baseline|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
11022512|NCT01165281|BG001|Baseline|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
11022513|NCT01165281|BG002|Baseline|Total|Total of all reporting groups
11022514|NCT01165281|FG000|Participant Flow|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
11022515|NCT01165281|FG001|Participant Flow|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
11022516|NCT01165281|OG000|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
11022517|NCT01165281|OG001|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
11022518|NCT01165281|EG000|Reported Event|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
11066250|NCT01391299|OG000|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
11066251|NCT01391299|OG001|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
11336574|NCT03569020|BG000|Baseline|Dietitian-Directed Diet Then Self-Directed Diet|"Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.~Subsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet."
11022519|NCT01165281|EG001|Reported Event|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
11022520|NCT01165307|BG000|Baseline|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
11022521|NCT01165307|BG001|Baseline|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
11022522|NCT01165307|BG002|Baseline|Total|Total of all reporting groups
11022523|NCT01165307|FG000|Participant Flow|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
11022524|NCT01165307|FG001|Participant Flow|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
11022525|NCT01165307|OG000|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
11022526|NCT01165307|OG001|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
11022527|NCT01165307|EG000|Reported Event|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
11022528|NCT01165307|EG001|Reported Event|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
11022529|NCT01165320|BG000|Baseline|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
11022530|NCT01165320|BG001|Baseline|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
11022531|NCT01165320|BG002|Baseline|Total|Total of all reporting groups
11022532|NCT01165320|FG000|Participant Flow|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
11022533|NCT01165320|FG001|Participant Flow|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
11022534|NCT01165320|FG002|Participant Flow|Participants With Esophageal Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively.
11022535|NCT01165320|OG000|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
11022536|NCT01165320|OG001|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
11022537|NCT01165320|EG000|Reported Event|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
11022538|NCT01165320|EG001|Reported Event|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
11022539|NCT01165541|BG000|Baseline|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg) for 7 weeks.
11022540|NCT01165541|FG000|Participant Flow|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg) for 7 weeks.
11022541|NCT01165541|OG000|Outcome|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg~Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
11022542|NCT01165541|OG001|Outcome|Quetiapine XR Plus Mirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg~Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg)"
11022543|NCT01165541|EG000|Reported Event|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg~Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
11022544|NCT01165541|EG001|Reported Event|Quetiapine XR andMirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg~Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg)"
11022545|NCT01165554|BG000|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
11225783|NCT02370394|BG000|Baseline|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
11022546|NCT01165554|FG000|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
11022547|NCT01165554|OG000|Outcome|Sensitivity Percentage of Abnormal Visual Reads|
11022548|NCT01165554|OG000|Outcome|Specificity Percentage of Normal Visual Reads|
11022549|NCT01165554|OG000|Outcome|Sensitivity-Abnormal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
11022550|NCT01165554|OG000|Outcome|Specificity-Normal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
11336575|NCT03569020|BG001|Baseline|Self-Directed Diet Then Dietitian-Directed Diet|Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
11022551|NCT01165554|EG000|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
11022552|NCT01165684|BG000|Baseline|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
11022553|NCT01165684|BG001|Baseline|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
11022554|NCT01165684|BG002|Baseline|Total|Total of all reporting groups
11022555|NCT01165684|FG000|Participant Flow|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
11022556|NCT01165684|FG001|Participant Flow|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
11022557|NCT01165684|OG000|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
11022558|NCT01165684|OG001|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
11066252|NCT01391299|OG002|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
11022559|NCT01165684|EG000|Reported Event|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
11022560|NCT01165684|EG001|Reported Event|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
11022561|NCT01165775|BG000|Baseline|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.~Data are available for 15 of 17 participants."
11022562|NCT01165775|FG000|Participant Flow|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
11022563|NCT01165775|OG000|Outcome|Non-Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
11022564|NCT01165775|OG001|Outcome|Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
11022565|NCT01165775|OG000|Outcome|Neonates With Hypoglycemia|Neonates with hypoglycemia from birth to hospital discharge.
11022566|NCT01165775|OG001|Outcome|Neonates Without Hypoglycemia|Neonates without hypoglycemia from birth to hospital discharge.
11022567|NCT01165775|OG002|Outcome|Neonates With Unknown Hypoglycemia Status|Neonates with unknown hypoglycemia status from birth to hospital discharge.
11022568|NCT01165775|EG000|Reported Event|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
11022569|NCT01165840|BG000|Baseline|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
11022570|NCT01165840|FG000|Participant Flow|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
11022571|NCT01165840|OG000|Outcome|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
11022572|NCT01165840|EG000|Reported Event|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
11022573|NCT01165983|BG000|Baseline|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
11022574|NCT01165983|BG001|Baseline|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
11022575|NCT01165983|BG002|Baseline|Total|Total of all reporting groups
11022576|NCT01165983|FG000|Participant Flow|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
11022577|NCT01165983|FG001|Participant Flow|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
11022578|NCT01165983|OG000|Outcome|Subjects at Risk of DMII|
11022579|NCT01165983|OG001|Outcome|T2DM Patients|
11022580|NCT01165983|OG000|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
11022581|NCT01165983|OG001|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
11022582|NCT01165983|EG000|Reported Event|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
11022583|NCT01165983|EG001|Reported Event|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
11022584|NCT01165996|BG000|Baseline|Arm I: Decitabine 0.2mg/kg|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
11022585|NCT01165996|FG000|Participant Flow|Arm I: Decitabine 0.2mg/kg|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
11022586|NCT01165996|OG000|Outcome|Arm I: Decitabine 0.2mg/kg|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
11066253|NCT01391299|EG000|Reported Event|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
11066254|NCT01391299|EG001|Reported Event|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
11022587|NCT01165996|OG000|Outcome|Arm I: Decitabine 0.2mg/kg|"INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts &lt; 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~flow cytometry: Correlative studies~DNA methylation analysis: Correlative studies~cytogenetic analysis: Correlative studies~decitabine: Given subcutaneously~microarray analysis: Correlative studies~gene expression analysis: Correlative studies~pharmacological study: Correlative studies~polymorphism analysis: Correlative studies"
11022588|NCT01165996|EG000|Reported Event|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
11022589|NCT01166126|BG000|Baseline|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
11022590|NCT01166126|FG000|Participant Flow|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
11022591|NCT01166126|OG000|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
11022592|NCT01166126|EG000|Reported Event|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
11022593|NCT01166139|BG000|Baseline|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
11022594|NCT01166139|FG000|Participant Flow|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
11022595|NCT01166139|OG000|Outcome|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
11022596|NCT01166139|EG000|Reported Event|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
11022597|NCT01166230|BG000|Baseline|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
11022598|NCT01166230|BG001|Baseline|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
11022599|NCT01166230|BG002|Baseline|Total|Total of all reporting groups
11022600|NCT01166230|FG000|Participant Flow|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
11022601|NCT01166230|FG001|Participant Flow|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
11022602|NCT01166230|OG000|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
11022603|NCT01166230|OG001|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
11336576|NCT03569020|BG002|Baseline|Total|Total of all reporting groups
11022604|NCT01166230|EG000|Reported Event|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
11022605|NCT01166230|EG001|Reported Event|Patients With Ta/T1, Randomized to White Light Cystoscopy|
11022606|NCT01166282|BG000|Baseline|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
11022607|NCT01166282|BG001|Baseline|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
11022608|NCT01166282|BG002|Baseline|Total|Total of all reporting groups
11022609|NCT01166282|FG000|Participant Flow|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
11022610|NCT01166282|FG001|Participant Flow|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
11022611|NCT01166282|FG002|Participant Flow|Open-label Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
11225784|NCT02370394|BG001|Baseline|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
11022612|NCT01166282|OG000|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
11022613|NCT01166282|OG001|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
11022614|NCT01166282|OG002|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
11022615|NCT01166282|EG000|Reported Event|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
11022616|NCT01166282|EG001|Reported Event|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
11022617|NCT01166282|EG002|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
11022618|NCT01166347|BG000|Baseline|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
11022619|NCT01166347|BG001|Baseline|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
11022620|NCT01166347|BG002|Baseline|Total|Total of all reporting groups
11022621|NCT01166347|FG000|Participant Flow|HeartWare® Ventricular Assist System (VAS)|HeartWare® Ventricular Assist System(VAS): The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
11022622|NCT01166347|FG001|Participant Flow|Control Left Ventricular Assist Device (LVAD)|Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.
11022623|NCT01166347|OG000|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
11022624|NCT01166347|OG001|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
11022625|NCT01166347|EG000|Reported Event|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
11022626|NCT01166347|EG001|Reported Event|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
11022627|NCT01166373|BG000|Baseline|SSLF+BPMT|Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
11022628|NCT01166373|BG001|Baseline|SSLF+USUAL|Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
11022629|NCT01166373|BG002|Baseline|ULS+BPMT|Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
11022630|NCT01166373|BG003|Baseline|ULS+USUAL|Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
11022631|NCT01166373|BG004|Baseline|Total|Total of all reporting groups
11022632|NCT01166373|FG000|Participant Flow|SSLF+BPMT|Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
11022633|NCT01166373|FG001|Participant Flow|SSLF+USUAL|Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
11022634|NCT01166373|FG002|Participant Flow|ULS+BPMT|Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
11022635|NCT01166373|FG003|Participant Flow|ULS+USUAL|Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
11022636|NCT01166373|OG000|Outcome|SSLF+BPMT|Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
11022637|NCT01166373|OG001|Outcome|SSLF+USUAL|Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
11022638|NCT01166373|OG002|Outcome|ULS+BPMT|Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
11022639|NCT01166373|OG003|Outcome|ULS+USUAL|Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
11022640|NCT01166373|OG000|Outcome|Enrollment Video Arm|"Arm of subjects that will be shown a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process.~Enrollment video: Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process"
11225785|NCT02370394|BG002|Baseline|Total|Total of all reporting groups
11341314|NCT03681093|EG001|Reported Event|Fevipiprant 450 mg|Fevipiprant (QAW039) 450 mg once daily orally
11341315|NCT03681093|EG002|Reported Event|Placebo|Placebo once daily orally
11341316|NCT03681119|BG000|Baseline|Hospice IDT MembersHospice Clinicians (RNs, Social Workers, Ch|Hospice Clinicians (RNs, Social Workers, Chaplains) who are given training
11022641|NCT01166373|OG001|Outcome|No Video Intervention Arm|This group of subjects will not view a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process.
11022642|NCT01166373|EG000|Reported Event|SSLF+BPMT|Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
11022643|NCT01166373|EG001|Reported Event|SSLF+USUAL|Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
11022644|NCT01166373|EG002|Reported Event|ULS+BPMT|Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
11022645|NCT01166373|EG003|Reported Event|ULS+USUAL|Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
11022646|NCT01166438|BG000|Baseline|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
11022647|NCT01166438|BG001|Baseline|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
11022648|NCT01166438|BG002|Baseline|Total|Total of all reporting groups
11022649|NCT01166438|FG000|Participant Flow|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
11022650|NCT01166438|FG001|Participant Flow|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
11022651|NCT01166438|OG000|Outcome|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
11022652|NCT01166438|OG001|Outcome|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
11226864|NCT02378714|BG003|Baseline|BASC + Active Varenicline|"Behavioral activation for smoking cessation plus active varenicline~Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.~BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.~Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11066255|NCT01391299|EG002|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
11066256|NCT01391312|BG000|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
11066257|NCT01391312|BG001|Baseline|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
11066258|NCT01391312|BG002|Baseline|Total|Total of all reporting groups
11022653|NCT01166438|OG001|Outcome|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 months~Trospium chloride: Oral Trospium XR 60mg once a day for up to 2 months"
11022654|NCT01166438|EG000|Reported Event|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
11022655|NCT01166438|EG001|Reported Event|Standardized Anticholinergic Regimen|A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. Dose escalation or drug change will be based exclusively on the result of the Patient Global Symptom Control Rating. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
11022656|NCT01166568|BG000|Baseline|PresVIEW Implantation Non-Randomized|288 subjects that received the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months. This sample consists of; 16 randomized deferred implantation subjects, 32 randomized implantation subjects, and 282 non-randomized implanted subjects (i.e. all enrolled subjects).
11022657|NCT01166568|BG001|Baseline|PresVIEW Implantation - Randomized|33 randomized subjects entered into a immediate treatment (implantation) group. Subjects were followed for 24 months. Immediate treatment group data was compared to the Deferred Treatment group at 6 months.
11022658|NCT01166568|BG002|Baseline|PresVIEW Deferred Implantation - Randomized|16 randomized subjects entered into a deferred treatment (control) group arm. Subjects were followed for 6 months (observation). Subjects that completed the 6 month observation were then offered PresVIEW implantation.
11022659|NCT01166568|BG003|Baseline|Total|Total of all reporting groups
11022660|NCT01166568|FG000|Participant Flow|PresVIEW Implantation - Non-Randomized|Subjects in the non-randomized arm of the study were bilaterally implanted and followed for 24 months. Per the protocol, primary endpoint analysis was performed on the primary eye (only). Fellow eyes were followed for safety and summarized separately
11022661|NCT01166568|FG001|Participant Flow|PresVIEW Implantation - Randomized|A randomized sub-study was used to evaluate the early (6 Month) effectiveness of the PresVIEW™ Scleral Implants against a deferred control group (no treatment). Subjects in the randomized sub-study that were randomly assigned to the immediate treatment (surgical) group were bilaterally implanted and followed for 24 months. Pre-operative, 3 month and 6 month post-operative visual acuity for the primary eye was compared to the differed treatment group primary eye visual acuity results. Thirty-two subjects of the total 48 subjects participating in the randomized sub-study, were randomly assigned to receive immediate surgery.
11022662|NCT01166568|FG002|Participant Flow|PresVIEW Deferred Implantation - Randomized|Subjects in the randomized sub-study that were randomly assigned to the deferred treatment (control) group were bilaterally implanted after 6 months observation and followed for 24 months post-op. Sixteen subjects of the total 48 subjects participating in the randomized sub-study were randomly assigned to the control group and followed for 6 months prior to surgery (observation). These patients will provide additional informed consent for implantation and their results will be included in the total patient cohort for the PSI SGP-046. Total study participation will be either 6 months (if they did not elect treatment after 6 months observation), or 30 months (6 months observation + 24 months post-operative) if they elected treatment. The observation period included follow-up visits for Day 0 (baseline), 3 months, and 6 months for the randomized sub-study and visual acuity for the primary eye was compared to the immediate treatment group primary eye visual acuity for analysis.
11022663|NCT01166568|OG000|Outcome|Overall Study Population|A total of 330 subjects at 11 sites received implantation of the PSI and were followed for 24 months post surgical. As per the protocol, the primary eye is the unit of analysis and was used for primary endpoint analysis. Fellow eyes were followed for safety and summarized separately. The primary eyes of subjects participating in the randomized sub-study were analyzed separately, though, they were also considered part of the overall study if they received implantation of the PSI.
11066259|NCT01391312|FG000|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
11066260|NCT01391312|FG001|Participant Flow|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
11066261|NCT01391312|OG000|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
11066262|NCT01391312|OG001|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
11066263|NCT01391312|EG000|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
11066264|NCT01391312|EG001|Reported Event|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
11066265|NCT01391325|BG000|Baseline|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
11022664|NCT01166568|OG000|Outcome|Overall Study Population|A total of 330 subjects at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
11022665|NCT01166568|OG000|Outcome|Overall Study Population|A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
11022666|NCT01166568|EG000|Reported Event|PresVIEW Implantation - Single Arm|330 nonrandomized subjects entered into a single group arm to receive the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months.
11022667|NCT01166646|BG000|Baseline|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
11022668|NCT01166646|BG001|Baseline|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
11022669|NCT01166646|BG002|Baseline|Total|Total of all reporting groups
11022670|NCT01166646|FG000|Participant Flow|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
11022671|NCT01166646|FG001|Participant Flow|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
11022672|NCT01166646|OG000|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
11226865|NCT02378714|BG004|Baseline|Total|Total of all reporting groups
11022673|NCT01166646|OG001|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
11022674|NCT01166646|EG000|Reported Event|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
11022675|NCT01166646|EG001|Reported Event|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
11022676|NCT01166659|BG000|Baseline|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
11022677|NCT01166659|FG000|Participant Flow|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
11022678|NCT01166659|OG000|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
11022679|NCT01166659|EG000|Reported Event|Non-Ocular Adverse Events|At risk population for non-ocular adverse events is included with unit of subjects
11022680|NCT01166659|EG001|Reported Event|Ocular Adverse Events|At risk population for ocular adverse events is included with unit of eyes.
11022681|NCT01166750|BG000|Baseline|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
11022682|NCT01166750|BG001|Baseline|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
11022683|NCT01166750|BG002|Baseline|Total|Total of all reporting groups
11022684|NCT01166750|FG000|Participant Flow|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
11022685|NCT01166750|FG001|Participant Flow|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
11022686|NCT01166750|OG000|Outcome|CD-ROM Treatment|Jointstrong
11022687|NCT01166750|OG001|Outcome|Wait-List Control Group|
11022688|NCT01166750|EG000|Reported Event|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
11341317|NCT03681119|BG001|Baseline|Advanced Demential Patients|Dementia symptom management at home hospice edition: quality assurance performance improvement program
11341318|NCT03681119|BG002|Baseline|Total|Total of all reporting groups
11341319|NCT03681119|FG000|Participant Flow|Hospice IDT Members|Hospice Interdisciplinary Team (IDT)
11022689|NCT01166750|EG001|Reported Event|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
11022690|NCT01166763|BG000|Baseline|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
11022691|NCT01166763|FG000|Participant Flow|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
11022692|NCT01166763|OG000|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
11022693|NCT01166763|EG000|Reported Event|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
11022694|NCT01166945|BG000|Baseline|Arm A|Short Course Antibiotic
11022695|NCT01166945|BG001|Baseline|Arm B|Long Course Antibiotic
11022696|NCT01166945|BG002|Baseline|Total|Total of all reporting groups
11022697|NCT01166945|FG000|Participant Flow|Arm A - Short Course Placebo Comparator|"Short Course Antibiotic Treatment~Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days."
11022698|NCT01166945|FG001|Participant Flow|Arm B - Long Course Treatment|"Long Course Antibiotic Treatment~Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days."
11022699|NCT01166945|OG000|Outcome|Arm A|Short Course Antibiotic
11022700|NCT01166945|OG001|Outcome|Arm B|Long Course Antibiotic
11022701|NCT01166945|OG000|Outcome|Short Course|"Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.~Amoxicillin-Potassium Clavulanate Combination: All subjects will be started on treatment with 5 days of high dose amoxicillin (90mg/kg) with potassium clavulanate (6.4 mg/kg) twice daily in bottle A. The allocation to group B1 or B2 will be concealed until after the family and subject has signed the assent and consent, respectively. The maximum dose will be 2 gms twice daily. After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.~Placebo: After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days."
11022702|NCT01166945|OG001|Outcome|Long Course|"Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.~Amoxicillin-Potassium Clavulanate Combination: All subjects will be started on treatment with 5 days of high dose amoxicillin (90mg/kg) with potassium clavulanate (6.4 mg/kg) twice daily in bottle A. The allocation to group B1 or B2 will be concealed until after the family and subject has signed the assent and consent, respectively. The maximum dose will be 2 gms twice daily. After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days."
11022703|NCT01166945|EG000|Reported Event|Arm A|Short Course Antibiotic Treatment
11022704|NCT01166945|EG001|Reported Event|Arm B|Long Course Antibiotic Treatment
11022705|NCT01166958|BG000|Baseline|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
11022706|NCT01166958|BG001|Baseline|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
11022707|NCT01166958|BG002|Baseline|Total|Total of all reporting groups
11022708|NCT01166958|FG000|Participant Flow|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
11022709|NCT01166958|FG001|Participant Flow|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
11022710|NCT01166958|OG000|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
11022711|NCT01166958|OG001|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
11022712|NCT01166958|EG000|Reported Event|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
11022713|NCT01166958|EG001|Reported Event|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
10886604|NCT00495157|OG000|Outcome|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
11022714|NCT01166971|BG000|Baseline|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
11022715|NCT01166971|BG001|Baseline|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
11022716|NCT01166971|BG002|Baseline|Total|Total of all reporting groups
11022717|NCT01166971|FG000|Participant Flow|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
11022718|NCT01166971|FG001|Participant Flow|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
11022719|NCT01166971|OG000|Outcome|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
11022720|NCT01166971|OG001|Outcome|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
11022721|NCT01166971|EG000|Reported Event|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
11022722|NCT01166971|EG001|Reported Event|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
11022723|NCT01166984|BG000|Baseline|AB103 7.5 µg/kg|AB103 7.5 µg/kg administered as a single IV infusion
11022724|NCT01166984|BG001|Baseline|AB103 37.5 µg/kg|AB103 37.5 µg/kg administered as a single IV infusion
11022725|NCT01166984|BG002|Baseline|AB103 150 µg/kg|AB103 150 µg/kg administered as a single IV infusion
11022726|NCT01166984|BG003|Baseline|AB103 450 µg/kg|AB103 450 µg/kg administered as a single IV infusion
11022727|NCT01166984|BG004|Baseline|Placebo|Normal saline (0.9% sodium chloride) administered as a single IV infusion
11022728|NCT01166984|BG005|Baseline|Total|Total of all reporting groups
11022729|NCT01166984|FG000|Participant Flow|AB103 7.5 µg/kg|AB103 7.5 µg/kg single IV infusion
11022730|NCT01166984|FG001|Participant Flow|AB103 37.5 µg/kg|AB103 37.5 µg/kg single IV infusion
11022731|NCT01166984|FG002|Participant Flow|AB103 150 µg/kg|AB103 150 µg/kg single IV infusion
11022732|NCT01166984|FG003|Participant Flow|AB103 450 µg/kg|AB103 450 µg/kg single IV infusion
11022733|NCT01166984|FG004|Participant Flow|Placebo|Normal saline (0.9% sodium chloride) single IV infusion
11022734|NCT01166984|OG000|Outcome|AB103 7.5 µg/kg|Each subject received a single IV infusion of AB103 7.5 µg/kg
11022735|NCT01166984|OG001|Outcome|AB103 37.5 µg/kg|Each subject received a single IV infusion of AB103 37.5 µg/kg
11022736|NCT01166984|OG002|Outcome|AB103 150 µg/kg|Each subject received a single IV infusion of 150 µg/kg
11022737|NCT01166984|OG003|Outcome|AB103 450 µg/kg|Each subject received a single IV infusion of 450 µg/kg
11022738|NCT01166984|OG004|Outcome|Placebo|Each subject received a single IV infusion of normal saline (0.9% sodium chloride)
11022739|NCT01166984|OG000|Outcome|AB103 7.5 µg/kg|AB103 single IV infusion of 7.5 µg/kg
11022740|NCT01166984|OG001|Outcome|AB103 37.5 µg/kg|AB103 single IV infusion of 37.5 µg/kg
11022741|NCT01166984|OG002|Outcome|AB103 150 µg/kg|AB103 single IV infusion of 150 µg/kg
11022742|NCT01166984|OG003|Outcome|AB103 450 µg/kg|AB103 single IV infusion of 450 µg/kg
11022743|NCT01166984|OG004|Outcome|Placebo|Normal saline (0.9% sodium chloride) single IV infusion
11022744|NCT01166984|OG000|Outcome|AB103 37.5 µg/kg|Each subject received a single IV infusion of AB103 37.5 µg/kg
11022745|NCT01166984|OG001|Outcome|AB103 150 µg/kg|Each subject received a single IV infusion of AB103 150 µg/kg
11022746|NCT01166984|OG002|Outcome|AB103 450 µg/kg|Each subject received a single IV infusion of AB103 450 µg/kg
11022747|NCT01166984|OG002|Outcome|AB103 150 µg/kg|Each subject received a single IV infusion of AB103 150 µg/kg
11022748|NCT01166984|OG003|Outcome|AB103 450 µg/kg|Each subject received a single IV infusion of AB103 450 µg/kg
11022749|NCT01166984|EG000|Reported Event|AB103 7.5 µg/kg|AB103 7.5 µg/kg administered as a single IV infusion
11022750|NCT01166984|EG001|Reported Event|AB103 37.5 µg/kg|AB103 37.5 µg/kg administered as a single IV infusion
11022751|NCT01166984|EG002|Reported Event|AB103 150 µg/kg|AB103 150 µg/kg administered as a single IV infusion
11022752|NCT01166984|EG003|Reported Event|AB103 450 µg/kg|AB103 450 µg/kg administered as a single IV infusion
11022753|NCT01166984|EG004|Reported Event|Placebo|Normal saline (0.9% sodium chloride) administered as a single IV infusion
11022754|NCT01166997|BG000|Baseline|UFH (Alone)|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
11022755|NCT01166997|BG001|Baseline|UFH + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
11022756|NCT01166997|BG002|Baseline|Total|Total of all reporting groups
11022757|NCT01166997|FG000|Participant Flow|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
11341320|NCT03681119|FG001|Participant Flow|Advanced Demential Patients|Dementia symptom management at home hospice edition: quality assurance performance improvement program
11022758|NCT01166997|FG001|Participant Flow|Unfractionated Heparin (UFH) + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
11022759|NCT01166997|OG000|Outcome|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
11022760|NCT01166997|OG001|Outcome|Unfractionated Heprin + EkoSonic Procedure|Patients in this arm received anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
11066266|NCT01391325|FG000|Participant Flow|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
11341321|NCT03681119|OG000|Outcome|Hospice IDT Members|Hospice Clinicians (RNs, Social Workers, Chaplains) who are given training
11341322|NCT03681119|EG000|Reported Event|Advanced Demential Patients|Dementia symptom management at home hospice edition: quality assurance performance improvement program
11022761|NCT01166997|OG000|Outcome|Ultrasound Accelerated Thrombolysis|"Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.~EkoSonic Endovascular System: The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus."
11022762|NCT01166997|OG001|Outcome|Intravenous Unfractionated Heparin|"Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.~Unfractionated heparin: Intravenous unfractionated heparin used for anticoagulation treatment"
11022763|NCT01166997|EG000|Reported Event|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
11022764|NCT01166997|EG001|Reported Event|UFH + EkoSonic|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
11022765|NCT01167023|BG000|Baseline|Placebo|Participants received placebo orally, once daily for 30 days.
11022766|NCT01167023|BG001|Baseline|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
11022767|NCT01167023|BG002|Baseline|Total|Total of all reporting groups
11022768|NCT01167023|FG000|Participant Flow|7.5 mg Prasugrel|Participants were to receive 7.5 milligrams (mg) of prasugrel orally, once daily if they weighed ≥60 kilograms (kg) and if pharmacodynamic (PD) measures indicated that the 5-mg prasugrel dose did not produce a steady-state PD response equivalent to inhibition of platelet activation (IPA) ≥25%. Because these criteria were not met, no participants received 7.5 mg of prasugrel.
11022769|NCT01167023|FG001|Participant Flow|Placebo|Participants received placebo orally, once daily for 30 days.
11022770|NCT01167023|FG002|Participant Flow|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
11022771|NCT01167023|OG000|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
11022772|NCT01167023|OG001|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
11022773|NCT01167023|EG000|Reported Event|Placebo|Participants received placebo orally, once daily for 30 days.
11022774|NCT01167023|EG001|Reported Event|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
11022775|NCT01167140|BG000|Baseline|Group 1|
11022776|NCT01167140|FG000|Participant Flow|Treatment Group|
11022777|NCT01167140|OG000|Outcome|Treatment Group|
11022778|NCT01167140|EG000|Reported Event|Treatment Group|
11022779|NCT01167153|BG000|Baseline|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
11022780|NCT01167153|BG001|Baseline|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
11022781|NCT01167153|BG002|Baseline|Total|Total of all reporting groups
11022782|NCT01167153|FG000|Participant Flow|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
11022783|NCT01167153|FG001|Participant Flow|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
11022784|NCT01167153|OG000|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
11022785|NCT01167153|OG001|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
11022786|NCT01167153|EG000|Reported Event|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
11022787|NCT01167153|EG001|Reported Event|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
11022788|NCT01167179|BG000|Baseline|Usual Care|The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care.
11022789|NCT01167179|BG001|Baseline|Intervention|The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.
11022790|NCT01167179|BG002|Baseline|Total|Total of all reporting groups
11022791|NCT01167179|FG000|Participant Flow|Usual Care|The participants in the usual care group received care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in usual care.
11022792|NCT01167179|FG001|Participant Flow|Intervention|"The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model.The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation. Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.~During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes."
11022793|NCT01167179|OG000|Outcome|Usual Care|The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care.
11022794|NCT01167179|OG001|Outcome|Intervention|The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.
11022795|NCT01167179|EG000|Reported Event|Usual Care|The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care.
11022796|NCT01167179|EG001|Reported Event|Intervention|The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.
11022797|NCT01167192|BG000|Baseline|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
11022798|NCT01167192|FG000|Participant Flow|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
11022799|NCT01167192|OG000|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
11022800|NCT01167192|EG000|Reported Event|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
11022801|NCT01167257|BG000|Baseline|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80mg/40ml) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
11022802|NCT01167257|BG001|Baseline|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
11341323|NCT03681353|BG000|Baseline|Reduced Use Condition|"This arm includes six weeks of mobile contingency management treatment administered via a smart-phone based application (mobile CM), in which participants are provided monetary reinforcement for reducing cannabis use.~Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use."
11022803|NCT01167257|BG002|Baseline|Total|Total of all reporting groups
11022804|NCT01167257|FG000|Participant Flow|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
11022805|NCT01167257|FG001|Participant Flow|Control Arm|"Normal saline 50ml in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
11022806|NCT01167257|OG000|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
11022807|NCT01167257|OG001|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
11022808|NCT01167257|OG001|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
11022809|NCT01167257|OG000|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10ml in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
11022810|NCT01167257|OG000|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 Ll water) in single intravesical instillation, one time treatment at the treatment day"
11022811|NCT01167257|OG000|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
11022812|NCT01167257|EG000|Reported Event|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A'~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
11022813|NCT01167257|EG001|Reported Event|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation'~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
11022814|NCT01167426|BG000|Baseline|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
11022815|NCT01167426|FG000|Participant Flow|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
11022816|NCT01167426|OG000|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
11022817|NCT01167426|EG000|Reported Event|Period 1: Glatiramer Acetate 20 mg/1.0 mL|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1).
11022818|NCT01167426|EG001|Reported Event|Period 2: Glatirimer Actetate|Participants received once daily subcutaneous administration of glatiramer acetate 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
11022819|NCT01167452|BG000|Baseline|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose oral dose of TMP/SMX (1600 mg/320 mg).
11022820|NCT01167452|FG000|Participant Flow|Sulfamethoxazole/Trimethoprim|"2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)~Sulfamethoxazole/trimethoprim: 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose"
11022821|NCT01167452|OG000|Outcome|Sulfamethoxazole|Results from sulfamethoxazole analysis
11022822|NCT01167452|OG001|Outcome|Trimethoprim|Results from trimethoprim analysis
11022823|NCT01167452|EG000|Reported Event|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose of TMP/SMX (1600 mg/320 mg).
11022824|NCT01167504|BG000|Baseline|Saliva Sample Collection|Collection of whole mouth and parotid saliva
11022825|NCT01167504|FG000|Participant Flow|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
11022826|NCT01167504|OG000|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
11022827|NCT01167504|EG000|Reported Event|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
11022828|NCT01167569|BG000|Baseline|A-Ascorbic Acid (Vitamin C)|"Ascorbic Acid~Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours."
11022829|NCT01167569|BG001|Baseline|B-Placebo|"5% Dextrose Water or Normal Saline (placebo)~5 % Dextrose Water or Normal Saline: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours."
11022830|NCT01167569|BG002|Baseline|Total|Total of all reporting groups
11022831|NCT01167569|FG000|Participant Flow|A-Ascorbic Acid (Vitamin C)|"Ascorbic Acid~Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg every 4 hours x 48 hours."
11022832|NCT01167569|FG001|Participant Flow|B-5% Dextrose Water or Normal Saline (Placebo|"5% Dextrose Water or Normal Saline (placebo)~5 % Dextrose Water or Normal Saline: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours."
11022833|NCT01167569|OG000|Outcome|A-Ascorbic Acid (Vitamin C)|"Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours.~Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours."
11022834|NCT01167569|OG001|Outcome|B-Placebo|"5% Dextrose Water or Normal Saline (placebo) x 2 in the operating room followed by 5 % Dextrose Water or NS (placebo) every 4 hours X 48 hours.~5 % Dextrose Water or Normal Saline: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours."
11022835|NCT01167569|OG000|Outcome|A-Ascorbic Acid (Vitamin C)|"Ascorbic Acid~Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg every 4 hours x 48 hours."
11022836|NCT01167569|OG001|Outcome|B-5% Dextrose Water or Normal Saline (Placebo|"5% Dextrose Water or Normal Saline (placebo)~5 % Dextrose Water or Normal Saline: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours."
11022837|NCT01167569|EG000|Reported Event|A-Ascorbic Acid (Vitamin C)|"Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours.~Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours."
11022838|NCT01167569|EG001|Reported Event|B-5% Dextrose Water or Normal Saline|"5% Dextrose Water or Normal Saline (placebo) x 2 in the operating room followed by 5 % Dextrose Water or NS (placebo) every 4 hours X 48 hours.~5 % Dextrose Water or Normal Saline: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours."
11022839|NCT01167582|BG000|Baseline|Liberal Transfusion Strategy|Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
11022840|NCT01167582|BG001|Baseline|Restrictive Transfusion Strategy|"Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.~Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension."
11022841|NCT01167582|BG002|Baseline|Total|Total of all reporting groups
11022842|NCT01167582|FG000|Participant Flow|Liberal Transfusion Strategy|Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
11022843|NCT01167582|FG001|Participant Flow|Restrictive Transfusion Strategy|"Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.~Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension."
11022844|NCT01167582|OG000|Outcome|Liberal Transfusion Strategy|Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
11022845|NCT01167582|OG001|Outcome|Restrictive Transfusion Strategy|"Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.~Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension."
11022846|NCT01167582|EG000|Reported Event|Liberal Transfusion Strategy|Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
11022847|NCT01167582|EG001|Reported Event|Restrictive Transfusion Strategy|"Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.~Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension."
11066267|NCT01391325|OG000|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
11066268|NCT01391325|EG000|Reported Event|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
11022848|NCT01167595|BG000|Baseline|PEP uP Protocol|"PEP-uP protocol and treatment algorithm implemented for all patients in ICU.~PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet."
11022849|NCT01167595|BG001|Baseline|Standard Feeding Protocol|Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
11022850|NCT01167595|BG002|Baseline|Total|Total of all reporting groups
11022851|NCT01167595|FG000|Participant Flow|PEP uP Protocol|"PEP-uP protocol and treatment algorithm implemented for all patients in ICU.~PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet."
11022852|NCT01167595|FG001|Participant Flow|Standard Feeding Protocol|Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
11022853|NCT01167595|OG000|Outcome|PEP uP Protocol|"PEP-uP protocol and treatment algorithm implemented for all patients in ICU.~PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet."
11022854|NCT01167595|OG001|Outcome|Standard Feeding Protocol|Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
11022855|NCT01167595|EG000|Reported Event|PEP uP Protocol|"PEP-uP protocol and treatment algorithm implemented for all patients in ICU.~PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet."
11022856|NCT01167595|EG001|Reported Event|Standard Feeding Protocol|Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
11022857|NCT01167608|BG000|Baseline|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
11022858|NCT01167608|FG000|Participant Flow|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
11022859|NCT01167608|OG000|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
11022860|NCT01167608|OG000|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
11022861|NCT01167608|EG000|Reported Event|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
11022862|NCT01167634|BG000|Baseline|1 - Control|
11022863|NCT01167634|BG001|Baseline|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match~Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022864|NCT01167634|BG002|Baseline|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match~Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
10849755|NCT00298038|FG000|Participant Flow|Rifaximin|Participants were administered a single rifaximin 550 milligrams (mg) tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
11022865|NCT01167634|BG003|Baseline|Experimental 4 - Deposit With no Match|"Deposit contract with no match~Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022866|NCT01167634|BG004|Baseline|Total|Total of all reporting groups
11022867|NCT01167634|FG000|Participant Flow|1 - Control|"Control - no financial incentive or match~Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive."
11022868|NCT01167634|FG001|Participant Flow|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match~Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022869|NCT01167634|FG002|Participant Flow|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match~Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022870|NCT01167634|FG003|Participant Flow|Experimental 4 - Deposit With no Match|"Deposit contract with no match~Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022871|NCT01167634|OG000|Outcome|1 - Control|Usual care arm
11022872|NCT01167634|OG001|Outcome|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match~Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022873|NCT01167634|OG002|Outcome|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match~Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022874|NCT01167634|OG003|Outcome|Experimental 4 - Deposit With no Match|"Deposit contract with no match~Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022875|NCT01167634|EG000|Reported Event|1 - Control|"Control - no financial incentive or match~Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive."
11022876|NCT01167634|EG001|Reported Event|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match~Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022877|NCT01167634|EG002|Reported Event|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match~Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022878|NCT01167634|EG003|Reported Event|Experimental 4 - Deposit Contract With no Match|"Deposit contract with no match~Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
11022879|NCT01167712|BG000|Baseline|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
11022880|NCT01167712|BG001|Baseline|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
11022881|NCT01167712|BG002|Baseline|Total|Total of all reporting groups
11022882|NCT01167712|FG000|Participant Flow|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV"
11022883|NCT01167712|FG001|Participant Flow|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
11022884|NCT01167712|OG000|Outcome|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV"
11022885|NCT01167712|OG001|Outcome|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
11022886|NCT01167712|EG000|Reported Event|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV"
11022887|NCT01167712|EG001|Reported Event|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
11022888|NCT01167829|BG000|Baseline|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
11022889|NCT01167829|FG000|Participant Flow|Acyline and 0ral Testosterone|Acyline 300 mcg/kg subcutaneous + 300mg modified slow-release oral testosterone tid
11022890|NCT01167829|OG000|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
11022891|NCT01167829|OG000|Outcome|Acyine and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
11022892|NCT01167829|OG000|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
11022893|NCT01167829|EG000|Reported Event|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
11022894|NCT01167881|BG000|Baseline|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
11022895|NCT01167881|BG001|Baseline|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
11022896|NCT01167881|BG002|Baseline|Total|Total of all reporting groups
11022897|NCT01167881|FG000|Participant Flow|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
11022898|NCT01167881|FG001|Participant Flow|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
11022899|NCT01167881|OG000|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
11022900|NCT01167881|OG001|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
11022901|NCT01167881|EG000|Reported Event|Empa 25mg|Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
11022902|NCT01167881|EG001|Reported Event|Glimepiride|Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
11022903|NCT01167907|BG000|Baseline|0.2% Ropivacaine|"Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.~0.2% ropivacaine: 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement~saline: saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement"
11022904|NCT01167907|BG001|Baseline|Saline|"Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.~saline: saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement"
11022905|NCT01167907|BG002|Baseline|Total|Total of all reporting groups
11022906|NCT01167907|FG000|Participant Flow|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
11022907|NCT01167907|FG001|Participant Flow|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
11022908|NCT01167907|OG000|Outcome|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
11022909|NCT01167907|OG001|Outcome|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
11022910|NCT01167907|EG000|Reported Event|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
11022911|NCT01167907|EG001|Reported Event|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
11022912|NCT01168024|BG000|Baseline|CINCOR™ System Treatment|"Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.~CINCOR™ System and CCS-1: Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media~Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
11022913|NCT01168024|BG001|Baseline|Standard of Care|"Peri-procedural hydration with isotonic saline or sodium bicarbonate for at least 2 hours prior to the procedure and 6-12 hours post-procedure.~Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
11022914|NCT01168024|BG002|Baseline|Total|Total of all reporting groups
11022915|NCT01168024|FG000|Participant Flow|CINCOR™ System and CCS-1|Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
11022916|NCT01168024|FG001|Participant Flow|Standard of Care Plus Peri-procedural Hydration|Peri-procedural hydration utilized prior to standard of care PCI.
11022917|NCT01168024|OG000|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
11022918|NCT01168024|OG001|Outcome|Control|Peri-procedure hydration
11022919|NCT01168024|EG000|Reported Event|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
11022920|NCT01168024|EG001|Reported Event|Control|Peri-procedure hydration
11022921|NCT01168232|BG000|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
11022922|NCT01168232|FG000|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
11022923|NCT01168232|OG000|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
11022924|NCT01168232|EG000|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
11022925|NCT01168349|BG000|Baseline|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022926|NCT01168349|FG000|Participant Flow|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022927|NCT01168349|OG000|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022928|NCT01168349|OG001|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia [CLL], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022929|NCT01168349|OG002|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022930|NCT01168349|OG001|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022931|NCT01168349|OG000|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
11022932|NCT01168349|OG001|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
11022933|NCT01168349|OG000|Outcome|Lung Cancer Participants|Lung cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022934|NCT01168349|OG001|Outcome|Breast Cancer Participants|Breast cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022935|NCT01168349|OG002|Outcome|Colon/Rectum Cancer Participants|Colon/rectum cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
10886605|NCT00495157|OG001|Outcome|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
11022936|NCT01168349|OG003|Outcome|Ovary Cancer Participants|Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022937|NCT01168349|OG004|Outcome|Multiple Myeloma Participants|Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022938|NCT01168349|OG005|Outcome|Non-Hodgkin's Lymphoma Participants|Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022939|NCT01168349|OG006|Outcome|Hodgkin's Lymphoma Participants|Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022940|NCT01168349|OG007|Outcome|Chronic Lymphocytic Leukemia Participants|Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022941|NCT01168349|OG008|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
10886606|NCT00495157|OG002|Outcome|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
11022942|NCT01168349|EG000|Reported Event|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022943|NCT01168349|EG001|Reported Event|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022944|NCT01168349|EG002|Reported Event|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
11022945|NCT01168401|BG000|Baseline|Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg|Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022946|NCT01168401|BG001|Baseline|Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg|Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022947|NCT01168401|BG002|Baseline|Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022948|NCT01168401|BG003|Baseline|Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg|Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022949|NCT01168401|BG004|Baseline|Cohort A1-A4: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022950|NCT01168401|BG005|Baseline|Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
11022951|NCT01168401|BG006|Baseline|Cohort B: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
11022952|NCT01168401|BG007|Baseline|Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
11022953|NCT01168401|BG008|Baseline|Cohort C: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
11022954|NCT01168401|BG009|Baseline|Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022955|NCT01168401|BG010|Baseline|Cohort D: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022956|NCT01168401|BG011|Baseline|Total|Total of all reporting groups
11022957|NCT01168401|FG000|Participant Flow|Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg|Norovirus bivalent Virus-Like Particle (VLP) Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022958|NCT01168401|FG001|Participant Flow|Cohort A2:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg|Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022959|NCT01168401|FG002|Participant Flow|Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022960|NCT01168401|FG003|Participant Flow|Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg|Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022961|NCT01168401|FG004|Participant Flow|Cohort A1-A4: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9 percent [%] sodium chloride [NaCl] and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022962|NCT01168401|FG005|Participant Flow|Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
11022963|NCT01168401|FG006|Participant Flow|Cohort B: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
11022964|NCT01168401|FG007|Participant Flow|Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
11022965|NCT01168401|FG008|Participant Flow|Cohort C: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
11022966|NCT01168401|FG009|Participant Flow|Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022967|NCT01168401|FG010|Participant Flow|Cohort D: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022968|NCT01168401|OG000|Outcome|Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg|Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022969|NCT01168401|OG001|Outcome|Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg|Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022970|NCT01168401|OG002|Outcome|Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022971|NCT01168401|OG003|Outcome|Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg|Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022972|NCT01168401|OG004|Outcome|Cohort A1-A4: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022973|NCT01168401|OG005|Outcome|Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
11022974|NCT01168401|OG006|Outcome|Cohort B: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
11022975|NCT01168401|OG007|Outcome|Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
11022976|NCT01168401|OG008|Outcome|Cohort C: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
11022977|NCT01168401|OG009|Outcome|Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022978|NCT01168401|OG010|Outcome|Cohort D: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022979|NCT01168401|EG000|Reported Event|Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg|Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022980|NCT01168401|EG001|Reported Event|Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg|Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022981|NCT01168401|EG002|Reported Event|Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022982|NCT01168401|EG003|Reported Event|Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg|Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022983|NCT01168401|EG004|Reported Event|Cohort A1-A4: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022984|NCT01168401|EG005|Reported Event|Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
11022985|NCT01168401|EG006|Reported Event|Cohort B: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
11022986|NCT01168401|EG007|Reported Event|Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
11022987|NCT01168401|EG008|Reported Event|Cohort C: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
11022988|NCT01168401|EG009|Reported Event|Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg|Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022989|NCT01168401|EG010|Reported Event|Cohort D: Placebo|Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
11022990|NCT01168427|BG000|Baseline|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
10886607|NCT00495157|EG000|Reported Event|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
11022991|NCT01168427|FG000|Participant Flow|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
11022992|NCT01168427|OG000|Outcome|Implant Cohort|Patient with Reveal device implanted
11022993|NCT01168427|EG000|Reported Event|Implant Cohort|Patient with Reveal device implanted
11022994|NCT01168596|BG000|Baseline|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
11022995|NCT01168596|BG001|Baseline|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
11022996|NCT01168596|BG002|Baseline|Total|Total of all reporting groups
11022997|NCT01168596|FG000|Participant Flow|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
11022998|NCT01168596|FG001|Participant Flow|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
11022999|NCT01168596|OG000|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
11023000|NCT01168596|OG001|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
11023001|NCT01168596|EG000|Reported Event|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
11023002|NCT01168596|EG001|Reported Event|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
11023003|NCT01168674|BG000|Baseline|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
11023004|NCT01168674|FG000|Participant Flow|Placebo-washout-ziprasidone|Placebo : The once-daily total daily dose will be 80-160 mg/d of the sugar pill. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Ziprazidone, for another 6 weeks, using same dosing techniques.
11023005|NCT01168674|FG001|Participant Flow|Ziprasidone-washout-placebo|ziprasidone : Ziprasidone will be administered as a pill. The once-daily total daily dose will be 80-160 mg/d of ziprasidone. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Placebo, for another 6 weeks, using same dosing techniques.
11023006|NCT01168674|OG000|Outcome|Placebo|Subjects randomized to placebo in either the initial or crossover phase
11023007|NCT01168674|OG001|Outcome|Ziprasidone|Subjects randomized to ziprasidone in either the initial or crossover phase.
11023008|NCT01168674|OG000|Outcome|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
11023009|NCT01168674|EG000|Reported Event|Placebo|Placebo administered double-blind.
11023010|NCT01168674|EG001|Reported Event|Ziprasidone|Active ziprasidone administered double-blind.
11023011|NCT01168687|BG000|Baseline|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
11023012|NCT01168687|BG001|Baseline|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days or will receive a double dose of placebo x 7 days.~Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
11023013|NCT01168687|BG002|Baseline|Total|Total of all reporting groups
11023014|NCT01168687|FG000|Participant Flow|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
11023015|NCT01168687|FG001|Participant Flow|Group B: Crossover Between High Dose Keppra and Placebo|Group B: Twenty moderate to heavy social alcohol users will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
11023016|NCT01168687|OG000|Outcome|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
11023017|NCT01168687|OG001|Outcome|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
11023018|NCT01168687|EG000|Reported Event|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
11023019|NCT01168687|EG001|Reported Event|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
11023020|NCT01168726|BG000|Baseline|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
11023021|NCT01168726|BG001|Baseline|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
11023022|NCT01168726|BG002|Baseline|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
11023023|NCT01168726|BG003|Baseline|Total|Total of all reporting groups
11023024|NCT01168726|FG000|Participant Flow|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
11023025|NCT01168726|FG001|Participant Flow|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
11023026|NCT01168726|FG002|Participant Flow|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
11023027|NCT01168726|OG000|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
11023028|NCT01168726|OG001|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
11023029|NCT01168726|OG002|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
11023030|NCT01168726|EG000|Reported Event|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
11023031|NCT01168726|EG001|Reported Event|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
11023032|NCT01168726|EG002|Reported Event|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
11023033|NCT01168856|BG000|Baseline|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
11023034|NCT01168856|BG001|Baseline|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
11023035|NCT01168856|BG002|Baseline|Total|Total of all reporting groups
11023036|NCT01168856|FG000|Participant Flow|Resistance Monitoring Arm|Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
11023037|NCT01168856|FG001|Participant Flow|Sustained Virological Response (SVR) Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
11023038|NCT01168856|OG000|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
11023039|NCT01168856|OG000|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
11023040|NCT01168856|OG000|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
11023041|NCT01168856|OG000|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
11023042|NCT01168856|OG000|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
11023043|NCT01168856|OG000|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in the following donor protocol: NP28266 [NCT01628094]. Patients had developed STV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
10886608|NCT00495157|EG001|Reported Event|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
10886609|NCT00495157|EG002|Reported Event|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
10886610|NCT00495170|BG000|Baseline|Concurrent Proton and Chemotherapy|Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
10886611|NCT00495170|FG000|Participant Flow|Concurrent Proton and Chemotherapy|Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
10886612|NCT00495170|OG000|Outcome|Concurrent Proton and Chemotherapy|Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
10886613|NCT00495170|EG000|Reported Event|Concurrent Proton and Chemotherapy|Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
10886614|NCT00495391|BG000|Baseline|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
10886615|NCT00495391|BG001|Baseline|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
10886616|NCT00495391|BG002|Baseline|Total|Total of all reporting groups
10886617|NCT00495391|FG000|Participant Flow|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
10886618|NCT00495391|FG001|Participant Flow|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
10886619|NCT00495391|OG000|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
10886620|NCT00495391|OG001|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
10886621|NCT00495391|EG000|Reported Event|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
11023044|NCT01168856|OG000|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV20536 [NCT00869661], WV21913 [NCT01331850], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], NP28266 [NCT01628094]. None of the enrolled patients had developed MCB-associated resistant mutation(s) in donor protocol. Participants were monitored up to 18 months.
11023045|NCT01168856|EG000|Reported Event|Resistance Monitoring Arm|Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations.
11023046|NCT01168856|EG001|Reported Event|SVR Durability Monitoring Arm|Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication.
11023047|NCT01168908|BG000|Baseline|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
11023048|NCT01168908|BG001|Baseline|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
11023049|NCT01168908|BG002|Baseline|Total|Total of all reporting groups
11023050|NCT01168908|FG000|Participant Flow|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
11023051|NCT01168908|FG001|Participant Flow|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
11023052|NCT01168908|OG000|Outcome|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
11023053|NCT01168908|OG001|Outcome|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
11023054|NCT01168908|EG000|Reported Event|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
11023055|NCT01168908|EG001|Reported Event|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
11023056|NCT01168934|BG000|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 50 mg IV first and crizotinib 250 mg oral first.
11023057|NCT01168934|FG000|Participant Flow|Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral|Single intravenous (IV) dose of crizotinib 50 milligram (mg) in first intervention period; and single oral dose of crizotinib 250 mg immediate release tablet (IRT) in second intervention period. A washout period of at least 14 days was maintained between each period.
11023058|NCT01168934|FG001|Participant Flow|Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV|Single oral dose of crizotinib 250 mg IRT in first intervention period; and single IV dose of crizotinib 50 mg in second intervention period. A washout period of at least 14 days was maintained between each period.
11023059|NCT01168934|OG000|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
11023060|NCT01168934|OG001|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
11023061|NCT01168934|OG000|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
11023062|NCT01168934|EG000|Reported Event|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
11023063|NCT01168934|EG001|Reported Event|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
11023064|NCT01168973|BG000|Baseline|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
11023065|NCT01168973|BG001|Baseline|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
11023066|NCT01168973|BG002|Baseline|Total|Total of all reporting groups
10886622|NCT00495391|EG001|Reported Event|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
10886623|NCT00495469|BG000|Baseline|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
11023067|NCT01168973|FG000|Participant Flow|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab drug product (DP) followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 milligrams per kilogram (mg/kg) administered intravenously.~Docetaxel: 75 milligrams per square meter (mg/m^2) (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
11023068|NCT01168973|FG001|Participant Flow|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
10886624|NCT00495469|BG001|Baseline|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886625|NCT00495469|BG002|Baseline|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886626|NCT00495469|BG003|Baseline|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886627|NCT00495469|BG004|Baseline|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886628|NCT00495469|BG005|Baseline|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
10886629|NCT00495469|BG006|Baseline|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
10886630|NCT00495469|BG007|Baseline|Total|Total of all reporting groups
10886631|NCT00495469|FG000|Participant Flow|Placebo|Participants received 2 placebo tablets matching for GSK189075 twice daily (BID) before breakfast and dinner and 1 placebo capsule matching for Pioglitazone once daily (QD) before breakfast for 12 weeks
10886632|NCT00495469|FG001|Participant Flow|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 milligrams (mg) each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886633|NCT00495469|FG002|Participant Flow|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886634|NCT00495469|FG003|Participant Flow|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886635|NCT00495469|FG004|Participant Flow|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886636|NCT00495469|FG005|Participant Flow|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
10886637|NCT00495469|FG006|Participant Flow|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
11023069|NCT01168973|OG000|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
11023070|NCT01168973|OG001|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
11023071|NCT01168973|EG000|Reported Event|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
11023072|NCT01168973|EG001|Reported Event|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
11023073|NCT01168986|BG000|Baseline|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
11023074|NCT01168986|BG001|Baseline|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
11023075|NCT01168986|BG002|Baseline|No Intervention|Participants receive/perform no intervention
11023076|NCT01168986|BG003|Baseline|Total|Total of all reporting groups
11023077|NCT01168986|FG000|Participant Flow|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
11023078|NCT01168986|FG001|Participant Flow|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
11023079|NCT01168986|FG002|Participant Flow|No Intervention|Participants receive/perform no intervention
11023080|NCT01168986|OG000|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
11023081|NCT01168986|OG001|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
11023082|NCT01168986|OG002|Outcome|No Intervention|Participants receive/perform no intervention
11023083|NCT01168986|EG000|Reported Event|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
11023084|NCT01168986|EG001|Reported Event|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
11023085|NCT01168986|EG002|Reported Event|No Intervention|Participants receive/perform no intervention
11023086|NCT01168999|BG000|Baseline|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
11023087|NCT01168999|BG001|Baseline|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
11023088|NCT01168999|BG002|Baseline|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
11023089|NCT01168999|BG003|Baseline|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
11023090|NCT01168999|BG004|Baseline|Total|Total of all reporting groups
11023091|NCT01168999|FG000|Participant Flow|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
11023092|NCT01168999|FG001|Participant Flow|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
11023093|NCT01168999|FG002|Participant Flow|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
11023094|NCT01168999|FG003|Participant Flow|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
11023095|NCT01168999|OG000|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
11023096|NCT01168999|OG001|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
11023097|NCT01168999|OG002|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
11023098|NCT01168999|OG003|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
11023099|NCT01168999|EG000|Reported Event|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
11023100|NCT01168999|EG001|Reported Event|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
11023101|NCT01168999|EG002|Reported Event|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
11023102|NCT01168999|EG003|Reported Event|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
11023103|NCT01169038|BG000|Baseline|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
11023104|NCT01169038|FG000|Participant Flow|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
11023105|NCT01169038|OG000|Outcome|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
11023106|NCT01169038|EG000|Reported Event|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
11023107|NCT01169064|BG000|Baseline|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
11023108|NCT01169064|BG001|Baseline|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
11023109|NCT01169064|BG002|Baseline|Total|Total of all reporting groups
11023110|NCT01169064|FG000|Participant Flow|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
11023111|NCT01169064|FG001|Participant Flow|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
11023112|NCT01169064|OG000|Outcome|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
11023113|NCT01169064|OG001|Outcome|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
11023114|NCT01169064|OG000|Outcome|Silver Dressing|
11023115|NCT01169064|OG001|Outcome|Cloth Dressing|
11023116|NCT01169064|EG000|Reported Event|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days~No adverse events"
11023117|NCT01169064|EG001|Reported Event|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days~No adverse events"
11023118|NCT01169103|BG000|Baseline|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
11023119|NCT01169103|BG001|Baseline|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
11023120|NCT01169103|BG002|Baseline|Total|Total of all reporting groups
11023121|NCT01169103|FG000|Participant Flow|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
11023122|NCT01169103|FG001|Participant Flow|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
11023123|NCT01169103|OG000|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
11023124|NCT01169103|OG001|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
10886638|NCT00495469|OG000|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
11023125|NCT01169103|EG000|Reported Event|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
11023126|NCT01169103|EG001|Reported Event|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
11023127|NCT01169311|BG000|Baseline|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
11023128|NCT01169311|FG000|Participant Flow|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
11023129|NCT01169311|OG000|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
11023130|NCT01169311|OG000|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
11023131|NCT01169311|EG000|Reported Event|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
11023132|NCT01169337|BG000|Baseline|Arm A (Lenalidomide; Phase II)|Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11023133|NCT01169337|BG001|Baseline|Arm A (Lenalidomide; Phase III)|Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11023134|NCT01169337|BG002|Baseline|Arm B (Observation; Phase III)|Patients undergo observation until progression to symptomatic myeloma.
11023135|NCT01169337|BG003|Baseline|Total|Total of all reporting groups
11023136|NCT01169337|FG000|Participant Flow|Arm A (Lenalidomide; Phase II)|Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11023137|NCT01169337|FG001|Participant Flow|Arm A (Lenalidomide; Phase III)|Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11023138|NCT01169337|FG002|Participant Flow|Arm B (Observation; Phase III)|Patients undergo observation until progression to symptomatic myeloma.
11023139|NCT01169337|OG000|Outcome|Arm A (Lenalidomide; Phase II)|Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11023140|NCT01169337|OG000|Outcome|Arm A (Lenalidomide; Phase III)|Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11023141|NCT01169337|OG001|Outcome|Arm B (Observation; Phase III)|Patients undergo observation until progression to symptomatic myeloma.
11023142|NCT01169337|EG000|Reported Event|Arm A (Lenalidomide; Phase II)|Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11023143|NCT01169337|EG001|Reported Event|Arm A (Lenalidomide; Phase III)|Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11023144|NCT01169337|EG002|Reported Event|Arm B (Observation; Phase III)|Patients undergo observation until progression to symptomatic myeloma.
11023145|NCT01169350|BG000|Baseline|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
11023146|NCT01169350|FG000|Participant Flow|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
11023147|NCT01169350|OG000|Outcome|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
11023148|NCT01169350|EG000|Reported Event|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
11023149|NCT01169467|BG000|Baseline|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
11023150|NCT01169467|BG001|Baseline|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
11023151|NCT01169467|BG002|Baseline|Total|Total of all reporting groups
11023152|NCT01169467|FG000|Participant Flow|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
11023153|NCT01169467|FG001|Participant Flow|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
11023154|NCT01169467|OG000|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
11023155|NCT01169467|OG001|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
11023156|NCT01169467|EG000|Reported Event|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
11023157|NCT01169467|EG001|Reported Event|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
11023158|NCT01169493|BG000|Baseline|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023159|NCT01169493|BG001|Baseline|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023160|NCT01169493|BG002|Baseline|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023161|NCT01169493|BG003|Baseline|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023162|NCT01169493|BG004|Baseline|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023163|NCT01169493|BG005|Baseline|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023164|NCT01169493|BG006|Baseline|Total|Total of all reporting groups
11066269|NCT01391364|BG000|Baseline|SofLens in Investigational Solution|"Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.~SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days."
11023165|NCT01169493|FG000|Participant Flow|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023166|NCT01169493|FG001|Participant Flow|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023167|NCT01169493|FG002|Participant Flow|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023168|NCT01169493|FG003|Participant Flow|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023169|NCT01169493|FG004|Participant Flow|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023170|NCT01169493|FG005|Participant Flow|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
11023171|NCT01169493|OG000|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
11023172|NCT01169493|OG001|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
11023173|NCT01169493|OG002|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
11023174|NCT01169493|EG000|Reported Event|VVI-40|VVI-40: Pacing mode set to VVI-40, RV only pacing
11023175|NCT01169493|EG001|Reported Event|RV DDD-40|RV DDD-40: ICD programmed to DDD-40, RV only pacing with an AV interval producing QRS fusion on surface EKG.
11023176|NCT01169493|EG002|Reported Event|Bi-V DDD-40|Bi-V DDD-40: ICD programmed to Bi-V pacing at a lower rate of 40
11023177|NCT01169519|BG000|Baseline|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration~Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min~Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
11023178|NCT01169519|FG000|Participant Flow|Baseline/Sildenafil|Assessment of baseline hemodynamics followed by sildenafil infusion with repeat assessment of hemodynamics
11023179|NCT01169519|OG000|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.125mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
11023180|NCT01169519|OG001|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.35mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
11023181|NCT01169519|OG002|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.45mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
11023182|NCT01169519|OG003|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.25mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusionplasma concentration
11023183|NCT01169519|OG000|Outcome|Baseline|Assessment of baseline hemodynamics
11023184|NCT01169519|OG001|Outcome|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration~Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min~Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
11023185|NCT01169519|EG000|Reported Event|Dose = 0.125mg/kg|Subjects receiving a sildenafil dose of 0.125mg/kg IV over 20 min
11023186|NCT01169519|EG001|Reported Event|Dose = 0.25mg/kg|Subjects receiving a sildenafil dose of 0.25mg/kg IV over 20 min
11023187|NCT01169519|EG002|Reported Event|Dose = 0.35mg/kg|Subjects receiving a sildenafil dose of 0.35mg/kg IV over 20 min
11023188|NCT01169519|EG003|Reported Event|Dose = 0.45mg/kg|Subjects receiving a sildenafil dose of 0.45mg/kg IV over 20 min
11023189|NCT01169532|BG000|Baseline|Treatment (Ridaforolimus and Vorinostat)|"Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ridaforolimus: Given PO~vorinostat: Given PO~biopsy: Optional correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11023190|NCT01169532|FG000|Participant Flow|Treatment (Ridaforolimus and Vorinostat)|"Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ridaforolimus: Given PO~vorinostat: Given PO~biopsy: Optional correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11023191|NCT01169532|OG000|Outcome|Treatment (Ridaforolimus and Vorinostat)|"Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ridaforolimus: Given PO~vorinostat: Given PO~biopsy: Optional correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11023192|NCT01169532|EG000|Reported Event|Treatment (Ridaforolimus and Vorinostat)|"Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ridaforolimus: Given PO~vorinostat: Given PO~biopsy: Optional correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11023193|NCT01169558|BG000|Baseline|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
11023194|NCT01169558|FG000|Participant Flow|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
11023195|NCT01169558|OG000|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
11023196|NCT01169558|EG000|Reported Event|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
11023197|NCT01169636|BG000|Baseline|Phase I: Panobinostat + ICE 10 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023198|NCT01169636|BG001|Baseline|Phase I: Panobinostat + ICE 20 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023199|NCT01169636|BG002|Baseline|Phase I: Panobinostat + ICE 30 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023200|NCT01169636|BG003|Baseline|Phase II: Standard of Care (ICE)|Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
10849756|NCT00298038|FG001|Participant Flow|Placebo|Participants were administered a single matching placebo tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
11023201|NCT01169636|BG004|Baseline|Phase II: Panobinostat + ICE|Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
11023202|NCT01169636|BG005|Baseline|Total|Total of all reporting groups
11023203|NCT01169636|FG000|Participant Flow|Phase I: Panobinostat + ICE 10 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023204|NCT01169636|FG001|Participant Flow|Phase I: Panobinostat + ICE 20 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023205|NCT01169636|FG002|Participant Flow|Phase I: Panobinostat + ICE 30 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023206|NCT01169636|FG003|Participant Flow|Phase II: Standard of Care (ICE)|Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
11023207|NCT01169636|FG004|Participant Flow|Phase II: Panobinostat + ICE|Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
11023208|NCT01169636|OG000|Outcome|Phase I: Panobinostat + ICE (Maximal Tolerated Dose (MTD)|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1of ICE and during two weeks of C1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023209|NCT01169636|OG001|Outcome|Phase II: Standard of Care (ICE)|Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
11023210|NCT01169636|OG002|Outcome|Phase II Panobinostat + ICE|Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
11023211|NCT01169636|EG000|Reported Event|Phase I: Panobinostat + ICE 10 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023212|NCT01169636|EG001|Reported Event|Phase I: Panobinostat + ICE 20 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023213|NCT01169636|EG002|Reported Event|Phase I: Panobinostat + ICE 30 mg|The dose level for ICE is fixed. Patients received Panobinostat daily on Mon-Wed-Fri starting one week prior to cycle 1 of ICE and during two weeks of C 1-2 of ICE. Pre-defined dose levels of Panobinostat: Dose level -1 = 10 mg Dose level 0 = 20 mg: Dose level 1= 30 mg
11023214|NCT01169636|EG003|Reported Event|Phase II: Standard of Care (ICE)|Patients are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
11023215|NCT01169636|EG004|Reported Event|Phase II: Panobinostat+ICE|Participants are randomized between ICE and Panobinostat plus ICE arms using A Bayesian adaptive algorithm. The dose level for Panobinostat was determined to be dose level 1 at 30mg as MTD during the phase I expansion cohort.
11023216|NCT01169649|BG000|Baseline|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
11023217|NCT01169649|FG000|Participant Flow|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
11023218|NCT01169649|OG000|Outcome|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
11023219|NCT01169649|EG000|Reported Event|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
11023220|NCT01169675|BG000|Baseline|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
11023221|NCT01169675|BG001|Baseline|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
11023222|NCT01169675|BG002|Baseline|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
11023223|NCT01169675|BG003|Baseline|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
11023224|NCT01169675|BG004|Baseline|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
11023225|NCT01169675|BG005|Baseline|Total|Total of all reporting groups
11023226|NCT01169675|FG000|Participant Flow|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
11023227|NCT01169675|FG001|Participant Flow|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
11023228|NCT01169675|FG002|Participant Flow|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
11023229|NCT01169675|FG003|Participant Flow|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
11023230|NCT01169675|FG004|Participant Flow|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
11023231|NCT01169675|OG000|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
11023232|NCT01169675|OG001|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
11023233|NCT01169675|OG002|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
11023234|NCT01169675|OG003|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
11023235|NCT01169675|OG004|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
11023236|NCT01169675|EG000|Reported Event|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
11023237|NCT01169675|EG001|Reported Event|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
11023238|NCT01169675|EG002|Reported Event|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
11023239|NCT01169675|EG003|Reported Event|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
11023240|NCT01169675|EG004|Reported Event|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
11023241|NCT01169701|BG000|Baseline|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
11023242|NCT01169701|BG001|Baseline|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
11023243|NCT01169701|BG002|Baseline|Total|Total of all reporting groups
11023244|NCT01169701|FG000|Participant Flow|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
11023245|NCT01169701|FG001|Participant Flow|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
11023246|NCT01169701|OG000|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
11066270|NCT01391364|BG001|Baseline|SofLens in Currently Marketed Solution|"SofLens daily disposable contact lens packaged in currently marketed storage solution.~SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days."
11066271|NCT01391364|BG002|Baseline|Total|Total of all reporting groups
11023247|NCT01169701|OG001|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
11023248|NCT01169701|EG000|Reported Event|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
11023249|NCT01169701|EG001|Reported Event|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
11023250|NCT01169779|BG000|Baseline|Placebo|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
11023251|NCT01169779|BG001|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
11023252|NCT01169779|BG002|Baseline|Total|Total of all reporting groups
11023253|NCT01169779|FG000|Participant Flow|Placebo|1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
11023254|NCT01169779|FG001|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
11023255|NCT01169779|OG000|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
11023256|NCT01169779|OG001|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
11023257|NCT01169779|EG000|Reported Event|Placebo|1-step initiation regimen of volume matching placebo.
11023258|NCT01169779|EG001|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
11023259|NCT01169844|BG000|Baseline|AIN457/AIN457 3 mg/kg|Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
11023260|NCT01169844|BG001|Baseline|Placebo/AIN457 3 mg/kg|Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
11023261|NCT01169844|BG002|Baseline|Total|Total of all reporting groups
11023262|NCT01169844|FG000|Participant Flow|AIN457/AIN457 3 mg/kg.|Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
11023263|NCT01169844|FG001|Participant Flow|Placebo/AIN457 3 mg/kg|Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
11023264|NCT01169844|OG000|Outcome|AIN457/AIN457 3 mg/kg|Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
11023265|NCT01169844|OG001|Outcome|Placebo/AIN457 3 mg/kg|Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
11023266|NCT01169844|EG000|Reported Event|AIN457/AIN457 3 mg/kg|Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
11023267|NCT01169844|EG001|Reported Event|Placebo/AIN457 3 mg/kg|Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
11023268|NCT01169987|BG000|Baseline|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
11023269|NCT01169987|FG000|Participant Flow|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
11023270|NCT01169987|OG000|Outcome|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
11023271|NCT01169987|OG000|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
11023272|NCT01169987|OG001|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
11023273|NCT01169987|OG002|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
11023274|NCT01169987|OG003|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
11023275|NCT01169987|OG004|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
11023276|NCT01169987|OG005|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
11023277|NCT01169987|EG000|Reported Event|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
11023278|NCT01170039|BG000|Baseline|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
11023279|NCT01170039|BG001|Baseline|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
11023280|NCT01170039|BG002|Baseline|Total|Total of all reporting groups
11023281|NCT01170039|FG000|Participant Flow|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
11023282|NCT01170039|FG001|Participant Flow|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
11023283|NCT01170039|OG000|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
11023284|NCT01170039|OG001|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
11023285|NCT01170039|EG000|Reported Event|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
11023286|NCT01170039|EG001|Reported Event|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
11023287|NCT01170065|BG000|Baseline|Placebo|Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
11023288|NCT01170065|BG001|Baseline|Nintedanib 50 mg- 100 mg|Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
11023289|NCT01170065|BG002|Baseline|Nintedanib 150 mg|Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
11023290|NCT01170065|BG003|Baseline|Total|Total of all reporting groups
11023291|NCT01170065|FG000|Participant Flow|Placebo|Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
11023292|NCT01170065|FG001|Participant Flow|Nintedanib 50 mg- 100 mg|Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
11023293|NCT01170065|FG002|Participant Flow|Nintedanib 150 mg|Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
11023294|NCT01170065|OG000|Outcome|Placebo|Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
11023295|NCT01170065|OG001|Outcome|Nintedanib 50 mg- 100 mg|Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
11023296|NCT01170065|OG002|Outcome|Nintedanib 150 mg|Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
11023297|NCT01170065|EG000|Reported Event|Placebo|Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
11023298|NCT01170065|EG001|Reported Event|Nintedanib 50 mg- 100 mg|Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
11023299|NCT01170065|EG002|Reported Event|Nintedanib 150 mg|Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
11023300|NCT01170091|BG000|Baseline|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
11023301|NCT01170091|FG000|Participant Flow|Mirapex|Patients with RLS who had initiated with Mirapex
11023302|NCT01170091|OG000|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
11023303|NCT01170091|EG000|Reported Event|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
11023304|NCT01170117|BG000|Baseline|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill"
11023305|NCT01170117|BG001|Baseline|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
11023306|NCT01170117|BG002|Baseline|Total|Total of all reporting groups
11023307|NCT01170117|FG000|Participant Flow|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill."
11023308|NCT01170117|FG001|Participant Flow|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
11023309|NCT01170117|OG000|Outcome|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill."
11023310|NCT01170117|OG001|Outcome|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
11023311|NCT01170117|EG000|Reported Event|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill."
11023312|NCT01170117|EG001|Reported Event|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
11023313|NCT01170208|BG000|Baseline|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
11023314|NCT01170208|BG001|Baseline|Group II|Type 2 diabetes treated with basalbolus therapy
11023315|NCT01170208|BG002|Baseline|Group III|Type 2 diabetes treated with biphasic insulin.
11023316|NCT01170208|BG003|Baseline|Total|Total of all reporting groups
11023317|NCT01170208|FG000|Participant Flow|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
11023318|NCT01170208|FG001|Participant Flow|Group II|Type 2 diabetes treated with basalbolus therapy
11023319|NCT01170208|FG002|Participant Flow|Group III|Type 2 diabetes treated with biphasic insulin.
11023320|NCT01170208|OG000|Outcome|Group I|Type 1 diabetes treated with basal-bolus insulin the
11023321|NCT01170208|OG001|Outcome|Group II|Type 2 diabetes treated with basal bolus therapy
11023322|NCT01170208|OG002|Outcome|Group III|Type 2 diabetes treated with biphasic insulin
11023323|NCT01170208|OG000|Outcome|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
11023324|NCT01170208|OG001|Outcome|Group II|Type 2 diabetes treated with basalbolus therapy
11023325|NCT01170208|OG002|Outcome|Group III|Type 2 diabetes treated with biphasic insulin.
11023326|NCT01170208|EG000|Reported Event|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
11023327|NCT01170208|EG001|Reported Event|Group II|Type 2 diabetes treated with basalbolus therapy
11023328|NCT01170208|EG002|Reported Event|Group III|Type 2 diabetes treated with biphasic insulin.
11023329|NCT01170221|BG000|Baseline|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
11023330|NCT01170221|BG001|Baseline|Linezolid|Oral linezolid 600 mg twice daily for 10 days
11023331|NCT01170221|BG002|Baseline|Total|Total of all reporting groups
11023332|NCT01170221|FG000|Participant Flow|Tedizolid Phosphate|Oral Tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
11023333|NCT01170221|FG001|Participant Flow|Linezolid|Oral linezolid 600 mg twice daily for 10 days
11023334|NCT01170221|OG000|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
11023335|NCT01170221|OG001|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
11023336|NCT01170221|EG000|Reported Event|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
11023337|NCT01170221|EG001|Reported Event|Linezolid|Oral linezolid 600 mg twice daily for 10 days
11066272|NCT01391364|FG000|Participant Flow|SofLens in Investigational Solution|"Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.~SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days."
11066273|NCT01391364|FG001|Participant Flow|SofLens in Currently Marketed Solution|"SofLens daily disposable contact lens packaged in currently marketed storage solution.~SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days."
11066274|NCT01391364|OG000|Outcome|SofLens in Investigational Solution|"Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.~SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days."
11066275|NCT01391364|OG001|Outcome|SofLens in Currently Marketed Solution|"SofLens daily disposable contact lens packaged in currently marketed storage solution.~SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days."
11066276|NCT01391364|EG000|Reported Event|SofLens in Investigational Solution|"Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.~SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days."
11066277|NCT01391364|EG001|Reported Event|SofLens in Currently Marketed Solution|"SofLens daily disposable contact lens packaged in currently marketed storage solution.~SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days."
11066278|NCT01391468|BG000|Baseline|Placebo|Cornstarch: placebo will be given in 6 months
11066279|NCT01391468|BG001|Baseline|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
11066280|NCT01391468|BG002|Baseline|Total|Total of all reporting groups
11066281|NCT01391468|FG000|Participant Flow|Placebo|Cornstarch: placebo will be given in 6 months
11023338|NCT01170247|BG000|Baseline|Intranasal Ketamine|
11023339|NCT01170247|BG001|Baseline|Intramuscular Ketamine|
11023340|NCT01170247|BG002|Baseline|Total|Total of all reporting groups
11023341|NCT01170247|FG000|Participant Flow|Intranasal Ketamine|Enrolled 2 patients over 6 month period
11023342|NCT01170247|FG001|Participant Flow|Intramuscular Ketamine|
11023343|NCT01170247|OG000|Outcome|Intranasal Ketamine|Ketamine: Intranasal Ketamine (100 mg/mL)
11023344|NCT01170247|OG001|Outcome|Intramuscular Ketamine|Ketamine: Intramuscular Ketamine
11023345|NCT01170247|EG000|Reported Event|Intranasal Ketamine|None Reported
11023346|NCT01170247|EG001|Reported Event|Intramuscular Ketamine|None report
11023347|NCT01170273|BG000|Baseline|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
11023348|NCT01170273|BG001|Baseline|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
11023349|NCT01170273|BG002|Baseline|Total|Total of all reporting groups
11023350|NCT01170273|FG000|Participant Flow|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
11023351|NCT01170273|FG001|Participant Flow|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
11023352|NCT01170273|OG000|Outcome|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
11023353|NCT01170273|OG001|Outcome|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
11023354|NCT01170273|EG000|Reported Event|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
11023355|NCT01170273|EG001|Reported Event|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
11023356|NCT01170364|BG000|Baseline|Sibutramine First, Then Placebo|Participants in this group were randomized to begin with 7 days of 15mg of sibutramine, followed by 14 days of placebo.
11023357|NCT01170364|BG001|Baseline|Placebo First, Then Sibutramine|Participants in this group were randomized to begin with 14 days of placebo, followed by 7 days of 15mg of sibutramine.
11023358|NCT01170364|BG002|Baseline|Total|Total of all reporting groups
11023359|NCT01170364|FG000|Participant Flow|Sibutramine First, Then Placebo|This is a cross over design study. Participants in this arm begin with one week of 15mg sibutramine, followed by two weeks of placebo.
11023360|NCT01170364|FG001|Participant Flow|Placebo First, Then Sibutramine|This is a cross over design study. Participants in this arm begin with two weeks of placebo, followed by one week of 15mg of sibutramine
11023361|NCT01170364|OG000|Outcome|Sibutramine|In this arm, participants received sibutramine 15mg for 7 days
11023362|NCT01170364|OG001|Outcome|Placebo|In this arm, participants received placebo (for 15mg sibumtramine) for 7 days.
11023363|NCT01170364|EG000|Reported Event|Sibutramine|Participants who received sibutramine 15mg capsule every morning for 7 days.
11023364|NCT01170364|EG001|Reported Event|Placebo|Participants who received a placebo capsule (matching sibutramine 15mg) every morning for 7 days.
11023365|NCT01170390|BG000|Baseline|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
11023366|NCT01170390|BG001|Baseline|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
11023367|NCT01170390|BG002|Baseline|Total|Total of all reporting groups
11023368|NCT01170390|FG000|Participant Flow|All Participants|All participants were given a low dose oral contraceptive (Aviane) cyclically for 2 months
11023369|NCT01170390|FG001|Participant Flow|Study Arm #1 (Aviane and Aviane)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
11023370|NCT01170390|FG002|Participant Flow|Study Arm #2 (Aviane and Portia)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
11023371|NCT01170390|OG000|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
11023372|NCT01170390|OG001|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
11023373|NCT01170390|OG000|Outcome|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
11023374|NCT01170390|OG001|Outcome|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
11023375|NCT01170390|EG000|Reported Event|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
11023376|NCT01170390|EG001|Reported Event|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
11023377|NCT01170533|BG000|Baseline|All Study Participants|"This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).~The PPI could be omeprazole (first phase) or pantoprazole (second phase)."
11023378|NCT01170533|FG000|Participant Flow|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
11023379|NCT01170533|FG001|Participant Flow|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
11023380|NCT01170533|OG000|Outcome|Omeprazole Concomitant|Participants took omeprazole with clopidogrel concomitantly
11023381|NCT01170533|OG001|Outcome|Omeprazole Staggered|Participants took omeprazole with clopidogrel staggered
11023382|NCT01170533|OG002|Outcome|Pantoprazole Concomitant|Participants took pantoprazole with clopidogrel concomitantly
11023383|NCT01170533|OG003|Outcome|Pantoprazole Staggered|Participants took pantoprazole with clopidogrel staggered
11023384|NCT01170533|OG004|Outcome|Clopidogrel Only (Omeprazole Phase)|Participants took clopidogrel only
11023385|NCT01170533|OG005|Outcome|Clopidogrel Only (Pantoprazole Phase)|Participants took clopidogrel only
11023386|NCT01170533|EG000|Reported Event|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
11023387|NCT01170533|EG001|Reported Event|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
11023388|NCT01170546|BG000|Baseline|KLCIR|plate-loaded kneeling leg curl with internal rotation
11023389|NCT01170546|BG001|Baseline|SP (Squat Press)|plate-loaded squat press
11023390|NCT01170546|BG002|Baseline|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
11023391|NCT01170546|BG003|Baseline|Control|Control group
11023392|NCT01170546|BG004|Baseline|Total|Total of all reporting groups
11023393|NCT01170546|FG000|Participant Flow|KLCIR|plate-loaded kneeling leg curl with internal rotation
11023394|NCT01170546|FG001|Participant Flow|SP (Squat Press)|plate-loaded squat press
11023395|NCT01170546|FG002|Participant Flow|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
11023396|NCT01170546|FG003|Participant Flow|Control|Control group
11023397|NCT01170546|OG000|Outcome|KLCIR|plate-loaded kneeling leg curl with internal rotation
11023398|NCT01170546|OG001|Outcome|SP (Squat Press)|plate-loaded squat press
11023399|NCT01170546|OG002|Outcome|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
11023400|NCT01170546|OG003|Outcome|Control|Control group
11023401|NCT01170546|EG000|Reported Event|KLCIR|plate-loaded kneeling leg curl with internal rotation
11023402|NCT01170546|EG001|Reported Event|SP (Squat Press)|plate-loaded squat press
11023403|NCT01170546|EG002|Reported Event|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
11023404|NCT01170546|EG003|Reported Event|Control|Control group
11023405|NCT01170598|BG000|Baseline|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
11023406|NCT01170598|FG000|Participant Flow|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
11023407|NCT01170598|OG000|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
11023408|NCT01170598|EG000|Reported Event|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
11023409|NCT01170663|BG000|Baseline|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
11023410|NCT01170663|BG001|Baseline|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
11023411|NCT01170663|BG002|Baseline|Total|Total of all reporting groups
11023412|NCT01170663|FG000|Participant Flow|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
11023413|NCT01170663|FG001|Participant Flow|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
11023414|NCT01170663|OG000|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
11023415|NCT01170663|OG001|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
11023416|NCT01170663|EG000|Reported Event|Ramucirumab and Paclitaxel|8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
11023417|NCT01170663|EG001|Reported Event|Placebo and Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle.
11023418|NCT01170715|BG000|Baseline|Experimental Group|"Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.~Etanercept: self-administered for 52 weeks"
11023419|NCT01170715|FG000|Participant Flow|Experimental Group|"Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.~Etanercept: self-administered for 52 weeks"
11023420|NCT01170715|OG000|Outcome|Experimental Group|"Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.~Etanercept: self-administered for 52 weeks"
11023421|NCT01170715|EG000|Reported Event|Experimental Group|"Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.~Etanercept: self-administered for 52 weeks"
11023422|NCT01170754|BG000|Baseline|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
11023423|NCT01170754|BG001|Baseline|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
11341324|NCT03681353|FG000|Participant Flow|Reduced Use Condition|"This arm includes six weeks of mobile contingency management treatment administered via a smart-phone based application (mobile CM), in which participants are provided monetary reinforcement for reducing cannabis use.~Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use."
10849757|NCT00298038|OG000|Outcome|Rifaximin|Participants were administered a single rifaximin 550 mg tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
11023424|NCT01170754|BG002|Baseline|Total|Total of all reporting groups
11023425|NCT01170754|FG000|Participant Flow|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
11023426|NCT01170754|FG001|Participant Flow|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
11023427|NCT01170754|OG000|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
11023428|NCT01170754|OG001|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
11023429|NCT01170754|OG000|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
11023430|NCT01170754|OG001|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
11023431|NCT01170754|EG000|Reported Event|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
11023432|NCT01170754|EG001|Reported Event|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
11023433|NCT01170884|BG000|Baseline|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
11023434|NCT01170884|BG001|Baseline|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
11023435|NCT01170884|BG002|Baseline|Total|Total of all reporting groups
11023436|NCT01170884|FG000|Participant Flow|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
11023437|NCT01170884|FG001|Participant Flow|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
11023438|NCT01170884|OG000|Outcome|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
11023439|NCT01170884|OG001|Outcome|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
11023440|NCT01170884|EG000|Reported Event|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
11023441|NCT01170884|EG001|Reported Event|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
11023442|NCT01170949|BG000|Baseline|Miltefosine|
11023443|NCT01170949|BG001|Baseline|Placebo|
11023444|NCT01170949|BG002|Baseline|Total|Total of all reporting groups
11023445|NCT01170949|FG000|Participant Flow|Miltefosine|Week 1 - 50 mg miltefosine or placebo Week 2 - 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 - 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
11023446|NCT01170949|FG001|Participant Flow|Placebo|Week 1 - 50 mg miltefosine or placebo Week 2 - 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 - 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
11023447|NCT01170949|OG000|Outcome|Miltefosine|Miltefosine: 50 or 100 or 150mg per day
11023448|NCT01170949|OG001|Outcome|Placebo|Placebo: Placebo
11023449|NCT01170949|EG000|Reported Event|Miltefosine|
11023450|NCT01170949|EG001|Reported Event|Placebo|
11023451|NCT01170962|BG000|Baseline|Daclastavir (20mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023452|NCT01170962|BG001|Baseline|Daclastavir (60mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023453|NCT01170962|BG002|Baseline|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023454|NCT01170962|BG003|Baseline|Total|Total of all reporting groups
11023455|NCT01170962|FG000|Participant Flow|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023456|NCT01170962|FG001|Participant Flow|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023457|NCT01170962|FG002|Participant Flow|Placebo: Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023458|NCT01170962|OG000|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023459|NCT01170962|OG001|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023460|NCT01170962|OG002|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023461|NCT01170962|OG003|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023462|NCT01170962|OG004|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023463|NCT01170962|OG003|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11066282|NCT01391468|FG001|Participant Flow|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
11066283|NCT01391468|OG000|Outcome|Placebo|Cornstarch: placebo will be given in 6 months
11023464|NCT01170962|OG000|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023465|NCT01170962|OG001|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023466|NCT01170962|OG002|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023467|NCT01170962|OG001|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023468|NCT01170962|OG004|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily up to 24 weeks. Participants continued to receive pegIFNα-2a and ribavirin, up to 48 weeks followed by a post treatment follow-up period of 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023469|NCT01170962|OG003|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy.
11023470|NCT01170962|EG000|Reported Event|Daclatasvir (20 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023471|NCT01170962|EG001|Reported Event|Daclatasvir (60 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023472|NCT01170962|EG002|Reported Event|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
11023473|NCT01171118|BG000|Baseline|Physostigmine/Placebo|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuouslyCapsaicin : 0.075% topical cream applicationPlacebo:We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this.
11023474|NCT01171118|FG000|Participant Flow|Physostigmine vs. Placebo in Room Air vs. O2 During Sedation|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Physostigmine (PS) vs. Placebo were randomized by DAYS. Then, on each day, subjects were randomized to receive oxygen or room air first or second. But each subject went through BOTH days and both oxygen and room air on each day.~There were eight total possible sequences."
11023475|NCT01171118|OG000|Outcome|Physostigmine/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
11023476|NCT01171118|OG001|Outcome|Placebo/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
11023477|NCT01171118|OG002|Outcome|Physostigmine/Room Air|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
11023478|NCT01171118|OG003|Outcome|Placebo/Room Air|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
11023479|NCT01171118|EG000|Reported Event|Physostigmine|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application
11023480|NCT01171118|EG001|Reported Event|Placebo|We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in OSA patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study is physostigmine versus placebo.
11023481|NCT01171118|EG002|Reported Event|Oxygen|Subjects were assessed for two separate one hour periods of time -- one hour while breathing oxygen via a nasal cannula at 2 liters/minute
11023482|NCT01171118|EG003|Reported Event|Room Air|Subjects were assessed for two separate one hour periods of time -- one hour while breathing room air
11023483|NCT01171183|BG000|Baseline|Placebo|Placebo: Placebo
11023484|NCT01171183|BG001|Baseline|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
11023485|NCT01171183|BG002|Baseline|Total|Total of all reporting groups
11023486|NCT01171183|FG000|Participant Flow|Placebo|Placebo: Placebo
11023487|NCT01171183|FG001|Participant Flow|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
11023488|NCT01171183|OG000|Outcome|Placebo|Placebo: Placebo
11023489|NCT01171183|OG001|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
11023490|NCT01171183|EG000|Reported Event|Placebo|Placebo: Placebo
11023491|NCT01171183|EG001|Reported Event|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
11023492|NCT01171521|BG000|Baseline|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
11023493|NCT01171521|FG000|Participant Flow|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
11023494|NCT01171521|OG000|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
11023495|NCT01171521|EG000|Reported Event|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
11023496|NCT01171612|BG000|Baseline|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
11023497|NCT01171612|FG000|Participant Flow|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
11023498|NCT01171612|OG000|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
11023499|NCT01171612|OG000|Outcome|Not Withdrawal Antiplatelet Therapy|Patients wiht aspirin and/or clopidogrel withdrawal for 5 or more days
11023500|NCT01171612|OG001|Outcome|Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn)|Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days
11023501|NCT01171612|OG002|Outcome|Complete Withdrawal|patients with aspirin oand/or clopidogrel, which stopped therapy > 5 days
11023502|NCT01171612|EG000|Reported Event|Cardiac and Cerebrovascular Events|Adverse events registered independently related with antiplatelet therapy management
11023503|NCT01171625|BG000|Baseline|Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023504|NCT01171625|FG000|Participant Flow|Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023505|NCT01171625|OG000|Outcome|Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023506|NCT01171625|OG000|Outcome|Magna Ease™, Model 3300TFX - 1 Year Post-Implant|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023507|NCT01171625|OG001|Outcome|Magna Ease™, Model 3300TFX - 2 Year Post-Implant|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023508|NCT01171625|OG002|Outcome|Magna Ease™, Model 3300TFX - 3 Year Post-Implant|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023509|NCT01171625|OG003|Outcome|Magna Ease™, Model 3300TFX - 4 Year Post-Implant|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023510|NCT01171625|OG004|Outcome|Magna Ease™, Model 3300TFX - 5 Year Post-Implant|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023511|NCT01171625|OG005|Outcome|Magna Ease™, Model 3300TFX - 6 Year Post-Implant|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023512|NCT01171625|OG006|Outcome|Magna Ease™, Model 3300TFX - 7 Year Post-Implant|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023513|NCT01171625|OG007|Outcome|Magna Ease™, Model 3300TFX - 8 Year Post-Implant|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023514|NCT01171625|EG000|Reported Event|Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX|Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
11023515|NCT01171677|BG000|Baseline|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
11023516|NCT01171677|BG001|Baseline|Treatment as Usual|
11023517|NCT01171677|BG002|Baseline|Total|Total of all reporting groups
11066284|NCT01391468|OG001|Outcome|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
11066285|NCT01391468|OG000|Outcome|Placebo|"cornstarch~Cornstarch: placebo will be given in 6 months"
11066286|NCT01391468|OG001|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
11023518|NCT01171677|FG000|Participant Flow|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
11023519|NCT01171677|FG001|Participant Flow|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
11023520|NCT01171677|OG000|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
11023521|NCT01171677|OG001|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
11023522|NCT01171677|EG000|Reported Event|Intensati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
11023523|NCT01171677|EG001|Reported Event|Treatment As Usual|
11023524|NCT01171690|BG000|Baseline|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
11023525|NCT01171690|BG001|Baseline|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
11023526|NCT01171690|BG002|Baseline|Total|Total of all reporting groups
11023527|NCT01171690|FG000|Participant Flow|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
11023528|NCT01171690|FG001|Participant Flow|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
11023529|NCT01171690|OG000|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
11023530|NCT01171690|OG001|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
11023531|NCT01171690|EG000|Reported Event|Teriparatide|"The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.~There were no adverse events related to the use of teriparatide."
11023532|NCT01171690|EG001|Reported Event|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
11023533|NCT01171794|BG000|Baseline|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
11023534|NCT01171794|BG001|Baseline|Placebo|Visually identical placebo
11023535|NCT01171794|BG002|Baseline|Total|Total of all reporting groups
11023536|NCT01171794|FG000|Participant Flow|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
11023537|NCT01171794|FG001|Participant Flow|Placebo|Visually identical placebo
11023538|NCT01171794|OG000|Outcome|Ibuprofen|Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
11023539|NCT01171794|OG001|Outcome|Placebo|visually identical placebo
11023540|NCT01171794|EG000|Reported Event|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
11023541|NCT01171794|EG001|Reported Event|Placebo|visually identical placebo
11023542|NCT01171820|BG000|Baseline|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
11023543|NCT01171820|BG001|Baseline|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
11023544|NCT01171820|BG002|Baseline|Total|Total of all reporting groups
11023545|NCT01171820|FG000|Participant Flow|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
11023546|NCT01171820|FG001|Participant Flow|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI)
11023547|NCT01171820|OG000|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
11023548|NCT01171820|OG001|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
11023549|NCT01171820|EG000|Reported Event|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
11023550|NCT01171820|EG001|Reported Event|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
11023551|NCT01171924|BG000|Baseline|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
11023552|NCT01171924|BG001|Baseline|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
11023553|NCT01171924|BG002|Baseline|Total|Total of all reporting groups
11023554|NCT01171924|FG000|Participant Flow|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
11023555|NCT01171924|FG001|Participant Flow|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
11023556|NCT01171924|OG000|Outcome|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
11023557|NCT01171924|OG001|Outcome|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
11023558|NCT01171924|EG000|Reported Event|Arm A: 5 Days/Week|
11023559|NCT01171924|EG001|Reported Event|Arm B: 3 Days/Week|
11023560|NCT01171963|BG000|Baseline|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
11023561|NCT01171963|BG001|Baseline|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
11023562|NCT01171963|BG002|Baseline|Total|Total of all reporting groups
11023563|NCT01171963|FG000|Participant Flow|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
11023564|NCT01171963|FG001|Participant Flow|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
11023565|NCT01171963|OG000|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
11023566|NCT01171963|OG001|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
11023567|NCT01171963|OG000|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.Not Applicable
11023568|NCT01171963|OG001|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
11023569|NCT01171963|OG000|Outcome|Overall Study Arm|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
11023570|NCT01171963|EG000|Reported Event|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
11023571|NCT01171963|EG001|Reported Event|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
11023572|NCT01171976|BG000|Baseline|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
11023573|NCT01171976|BG001|Baseline|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
11023574|NCT01171976|BG002|Baseline|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
11023575|NCT01171976|BG003|Baseline|Total|Total of all reporting groups
11023576|NCT01171976|FG000|Participant Flow|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
11023577|NCT01171976|FG001|Participant Flow|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
11023578|NCT01171976|FG002|Participant Flow|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
11023579|NCT01171976|OG000|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
11023580|NCT01171976|OG001|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
11023581|NCT01171976|OG002|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
11023582|NCT01171976|EG000|Reported Event|TE Ranibizumab 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
11023583|NCT01171976|EG001|Reported Event|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
11023584|NCT01171976|EG002|Reported Event|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
11066287|NCT01391468|OG000|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
11066288|NCT01391468|OG001|Outcome|Placebo|Placeo group received maltodextrin for 6 months
11023585|NCT01171989|BG000|Baseline|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023586|NCT01171989|BG001|Baseline|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023587|NCT01171989|BG002|Baseline|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023588|NCT01171989|BG003|Baseline|Total|Total of all reporting groups
11023589|NCT01171989|FG000|Participant Flow|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023590|NCT01171989|FG001|Participant Flow|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023591|NCT01171989|FG002|Participant Flow|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023592|NCT01171989|OG000|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023593|NCT01171989|OG001|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023594|NCT01171989|OG002|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023595|NCT01171989|EG000|Reported Event|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023596|NCT01171989|EG001|Reported Event|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023597|NCT01171989|EG002|Reported Event|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
11023598|NCT01172067|BG000|Baseline|QuickOpt Group|Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
11023599|NCT01172067|BG001|Baseline|Echocardiography Group|Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography
11023600|NCT01172067|BG002|Baseline|Total|Total of all reporting groups
11066289|NCT01391468|OG001|Outcome|Placebo|Plabeco group received maltodextrin for 6 months
11023601|NCT01172067|FG000|Participant Flow|Quickopt Group|"the QuickOpt Group patients will be optimized by QuickOpt(IEGM);~Cardiac Resynchronization Therapy: Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation."
11023602|NCT01172067|FG001|Participant Flow|Echocardiography Group|"the Echo Group patients will be optimized by Echo.~Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography"
11023603|NCT01172067|OG000|Outcome|QuickOpt Group|Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
11023604|NCT01172067|OG001|Outcome|Echocardiography Group|Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography
11023605|NCT01172067|EG000|Reported Event|Quickopt Group|"the QuickOpt Group patients will be optimized by QuickOpt(IEGM);~Cardiac Resynchronization Therapy: Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation."
11023606|NCT01172067|EG001|Reported Event|Echocardiography Group|"the Echo Group patients will be optimized by Echo.~Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography"
11023607|NCT01172145|BG000|Baseline|Cholinesterase Inhibitor Only|participants who received placebo
11023608|NCT01172145|BG001|Baseline|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
11023609|NCT01172145|BG002|Baseline|Total|Total of all reporting groups
11023610|NCT01172145|FG000|Participant Flow|Cholinesterase Inhibitor Only|participants who received placebo
11023611|NCT01172145|FG001|Participant Flow|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
11023612|NCT01172145|OG000|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
11023613|NCT01172145|OG001|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
11023614|NCT01172145|EG000|Reported Event|Cholinesterase Inhibitor Only|participants who received placebo
11023615|NCT01172145|EG001|Reported Event|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
11023616|NCT01172184|BG000|Baseline|Patients With Either Chronic or Acute Mitral Regurgitation|
11023617|NCT01172184|FG000|Participant Flow|Patients With Either Chronic or Acute Mitral Regurgitation|
11023618|NCT01172184|OG000|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
11023619|NCT01172184|EG000|Reported Event|Patients With Either Chronic or Acute Mitral Regurgitation|
11023620|NCT01172197|BG000|Baseline|Ropivacaine|"Local anaesthetic bolus and infusion~Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
11023621|NCT01172197|BG001|Baseline|Levobupivacaine|"Local anaesthetic bolus and infusion~Ropivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
11023622|NCT01172197|BG002|Baseline|Total|Total of all reporting groups
11023623|NCT01172197|FG000|Participant Flow|Ropivacaine|"Local anaesthetic bolus and infusion~Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
11023624|NCT01172197|FG001|Participant Flow|Levobupivacaine|"Local anaesthetic bolus and infusion~Ropivacaine: Bolus and infusion"
11023625|NCT01172197|OG000|Outcome|Ropivacaine|"Local anaesthetic bolus and infusion~Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
11023626|NCT01172197|OG001|Outcome|Levobupivacaine|"Local anaesthetic bolus and infusion~Ropivacaine: Bolus and infusion"
11023627|NCT01172197|EG000|Reported Event|Ropivacaine|"Local anaesthetic bolus and infusion~Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
11023628|NCT01172197|EG001|Reported Event|Levobupivacaine|"Local anaesthetic bolus and infusion~Ropivacaine: Bolus and infusion"
11023629|NCT01172275|BG000|Baseline|N-Acetylcysteine|"N-Acetylcysteine effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial.~N-Acetylcysteine: 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial."
11023630|NCT01172275|BG001|Baseline|Placebo|"Placebo effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.~Placebo: 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial."
11023631|NCT01172275|BG002|Baseline|Total|Total of all reporting groups
11023632|NCT01172275|FG000|Participant Flow|N-Acetylcysteine|"N-Acetylcysteine effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial.~N-Acetylcysteine: 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial."
11023633|NCT01172275|FG001|Participant Flow|Placebo|"Placebo effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.~Placebo: 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial."
11023634|NCT01172275|OG000|Outcome|N-Acetylcysteine|"N-Acetylcysteine effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial.~N-Acetylcysteine: 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial."
11066290|NCT01391468|EG000|Reported Event|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
11066291|NCT01391468|EG001|Reported Event|Placebo|Cornstarch: placebo will be given in 6 months
11023635|NCT01172275|OG001|Outcome|Placebo|"Placebo effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.~Placebo: 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial."
11023636|NCT01172275|EG000|Reported Event|N-Acetylcysteine|"N-Acetylcysteine effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial.~N-Acetylcysteine: 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial."
11023637|NCT01172275|EG001|Reported Event|Placebo|"Placebo effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.~Placebo: 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial."
11023638|NCT01172288|BG000|Baseline|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
11023639|NCT01172288|BG001|Baseline|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
11023640|NCT01172288|BG002|Baseline|Total|Total of all reporting groups
11023641|NCT01172288|FG000|Participant Flow|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
11023642|NCT01172288|FG001|Participant Flow|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
11023643|NCT01172288|OG000|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
11023644|NCT01172288|OG001|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
11023645|NCT01172288|EG000|Reported Event|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
11023646|NCT01172288|EG001|Reported Event|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
11023647|NCT01172353|BG000|Baseline|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
11023648|NCT01172353|BG001|Baseline|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
11023649|NCT01172353|BG002|Baseline|Total|Total of all reporting groups
11023650|NCT01172353|FG000|Participant Flow|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
11023651|NCT01172353|FG001|Participant Flow|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
11023652|NCT01172353|OG000|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
11023653|NCT01172353|OG001|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
11023654|NCT01172353|EG000|Reported Event|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
11023655|NCT01172353|EG001|Reported Event|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
11023656|NCT01172418|BG000|Baseline|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
11023657|NCT01172418|BG001|Baseline|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
11023658|NCT01172418|BG002|Baseline|Total|Total of all reporting groups
11023659|NCT01172418|FG000|Participant Flow|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
11023660|NCT01172418|FG001|Participant Flow|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
11023661|NCT01172418|OG000|Outcome|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
11023662|NCT01172418|OG001|Outcome|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
11023663|NCT01172418|OG000|Outcome|Thymoglobulin and Daclizumab|
11023664|NCT01172418|OG001|Outcome|Thymoglobulin and Alemtuzumab|
11023665|NCT01172418|EG000|Reported Event|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
11023666|NCT01172418|EG001|Reported Event|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
11023667|NCT01172522|BG000|Baseline|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison.~Placebo, fexofenadine"
11023668|NCT01172522|BG001|Baseline|Fexofenadine Left Side; Placebo Right Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison.~Fexofenadine, placebo"
11023669|NCT01172522|BG002|Baseline|Total|Total of all reporting groups
11023670|NCT01172522|FG000|Participant Flow|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison. Participants were randomized to side of face with active drug versus side of face with control, but with each treatment going on concurrently."
11023671|NCT01172522|FG001|Participant Flow|Fexofenadine Left Side; Placebo Right Side|Subjects were randomized as to side of face treated with test article versus placebo
11023672|NCT01172522|OG000|Outcome|Fexofenadine|All participants that received fexofenadine
11023673|NCT01172522|OG001|Outcome|Placebo|All participants that received placebo
11023674|NCT01172522|EG000|Reported Event|Split Face Intrasubject Comparison|"Topical treatment active versus placebo~Double blind randomized placebo controlled split face intrasubject comparison."
11023675|NCT01172535|BG000|Baseline|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavirr, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
11023676|NCT01172535|FG000|Participant Flow|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
11023677|NCT01172535|OG000|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
11023678|NCT01172535|OG000|Outcome|Week 4|Participants bringing medication to be measured at study week 4
11023679|NCT01172535|OG001|Outcome|Week 12|Participants bringing medication to be measured at study week 12
11023680|NCT01172535|OG002|Outcome|Week 24|Participants bringing medication to be measured at study week 24
11023681|NCT01172535|EG000|Reported Event|LPV/r|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
11023682|NCT01172600|BG000|Baseline|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
11023683|NCT01172600|BG001|Baseline|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
11023684|NCT01172600|BG002|Baseline|Total|Total of all reporting groups
11023685|NCT01172600|FG000|Participant Flow|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
11023686|NCT01172600|FG001|Participant Flow|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
11023687|NCT01172600|OG000|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
11023688|NCT01172600|OG001|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
11023689|NCT01172600|EG000|Reported Event|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
11023690|NCT01172600|EG001|Reported Event|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
11023691|NCT01172639|BG000|Baseline|CoBRA Classic High Risk Group|"Methotrexate (MTX)~Sulphasalazine~Step down steroid full dose~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023692|NCT01172639|BG001|Baseline|CoBRA Slim High Risk Group|"MTX~Step down steroid half dose~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023693|NCT01172639|BG002|Baseline|CoBRA Avant-garde High Risk Group|"MTX~Leflunomide~Step down steroid half dose~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023694|NCT01172639|BG003|Baseline|CoBRA Slim Low Risk Group|"MTX~Step down steroid half dose~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023695|NCT01172639|BG004|Baseline|Tight Step Up Low Risk Group|"MTX~No additional oral steroids allowed~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023696|NCT01172639|BG005|Baseline|Total|Total of all reporting groups
11023697|NCT01172639|FG000|Participant Flow|CoBRA Classic High Risk Group|"Methotrexate 15mg tablet by mouth, weekly for entire trial~Sulfasalazine 2g tablet by mouth, daily for 40 weeks~Prednisone tablet by mouth, weekly step down scheme 60 - 40 - 25 - 20 - 15 - 10 mg daily for 6 weeks, followed by 7.5mg daily till week 28, then further tapered down to stop at week 32"
11023698|NCT01172639|FG001|Participant Flow|CoBRA Slim High Risk Group|"Methotrexate 15mg tablet by mouth, weekly for entire trial~Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32"
11023699|NCT01172639|FG002|Participant Flow|CoBRA Avant-garde High Risk Group|"Methotrexate 15mg tablet by mouth, weekly for 40 weeks (continued for entire trial if randomized to Methotrexate monotherapy at week 40)~Leflunomide 10mg tablet by mouth, daily for 40 weeks (continued for entire trial if randomized to Leflunomide monotherapy at week 40)~Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32"
11023700|NCT01172639|FG003|Participant Flow|CoBRA Slim Low Risk Group|"Methotrexate 15mg tablet by mouth, weekly for entire trial~Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32"
10849758|NCT00298038|OG001|Outcome|Placebo|Participants were administered a single matching placebo tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
11023701|NCT01172639|FG004|Participant Flow|Tight Step Up Low Risk Group|"Methotrexate 15mg tablet by mouth, weekly for entire trial~No oral steroids allowed during the first year of the trial"
11023702|NCT01172639|OG000|Outcome|CoBRA Classic High Risk Group|"Methotrexate (MTX)~Sulphasalazine~Step down steroid full dose"
11023703|NCT01172639|OG001|Outcome|CoBRA Slim High Risk Group|"MTX~Step down steroid half dose"
11023704|NCT01172639|OG002|Outcome|CoBRA Avant-garde High Risk Group|"MTX~Leflunomide~Step down steroid half dose"
11023705|NCT01172639|OG003|Outcome|CoBRA Slim Low Risk Group|"MTX~Step down steroid half dose"
11023706|NCT01172639|OG004|Outcome|Tight Step Up Low Risk Group|"MTX~No additional oral steroids allowed"
11023707|NCT01172639|EG000|Reported Event|CoBRA Classic High Risk Group|"Methotrexate (MTX)~Sulphasalazine~Step down steroid full dose~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023708|NCT01172639|EG001|Reported Event|CoBRA Slim High Risk Group|"MTX~Step down steroid half dose~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023709|NCT01172639|EG002|Reported Event|CoBRA Avant-garde High Risk Group|"MTX~Leflunomide~Step down steroid half dose~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023710|NCT01172639|EG003|Reported Event|CoBRA Slim Low Risk Group|"MTX~Step down steroid half dose~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023711|NCT01172639|EG004|Reported Event|Tight Step Up Low Risk Group|"MTX~No additional oral steroids allowed~randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata."
11023712|NCT01172808|BG000|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023713|NCT01172808|BG001|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
11023714|NCT01172808|BG002|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
11023715|NCT01172808|BG003|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023716|NCT01172808|BG004|Baseline|Total|Total of all reporting groups
11023717|NCT01172808|FG000|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023718|NCT01172808|FG001|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
11023719|NCT01172808|FG002|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
11023720|NCT01172808|FG003|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023721|NCT01172808|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023722|NCT01172808|OG001|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
11023723|NCT01172808|OG002|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
11023724|NCT01172808|OG003|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023725|NCT01172808|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023726|NCT01172808|EG001|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
11023727|NCT01172808|EG002|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
11023728|NCT01172808|EG003|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023729|NCT01172821|BG000|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023730|NCT01172821|BG001|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
11023731|NCT01172821|BG002|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
11023732|NCT01172821|BG003|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023733|NCT01172821|BG004|Baseline|Total|Total of all reporting groups
11023734|NCT01172821|FG000|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023735|NCT01172821|FG001|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
11023736|NCT01172821|FG002|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
11023737|NCT01172821|FG003|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023738|NCT01172821|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023739|NCT01172821|OG001|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
11023740|NCT01172821|OG002|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
11023741|NCT01172821|OG003|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023742|NCT01172821|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023743|NCT01172821|EG001|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
11023744|NCT01172821|EG002|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
11023745|NCT01172821|EG003|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
11023746|NCT01172847|BG000|Baseline|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
11023747|NCT01172847|FG000|Participant Flow|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
11023748|NCT01172847|OG000|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
11023749|NCT01172847|OG001|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
11023750|NCT01172847|OG000|Outcome|Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
11023751|NCT01172847|OG001|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
11023752|NCT01172847|OG002|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
11023753|NCT01172847|EG000|Reported Event|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
11023754|NCT01172847|EG001|Reported Event|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
11023755|NCT01172847|EG002|Reported Event|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
11023756|NCT01172873|BG000|Baseline|D-cycloserine + E/RP|Participants in this treatment arm received 10 twice-weekly sessions of E/RP treatment and were administered D-Cycloserine (DCS) immediately after every treatment visit.
11023757|NCT01172873|BG001|Baseline|E/RP Alone (no DCS Administration)|Five participants were enrolled in the second treatment arm as a comparison. The participants received 10 twice-weekly sessions of E/RP treatment alone.
11023758|NCT01172873|BG002|Baseline|Total|Total of all reporting groups
11023759|NCT01172873|FG000|Participant Flow|D-cycloserine + E/RP|The first 11 participants received 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
11023760|NCT01172873|FG001|Participant Flow|E/RP Alone (no DCS Administration)|The final 5 participants enrolled in the study were assigned to a second treatment arm, to compare E/RP alone to E/RP with D-Cycloserine. These participants received 10 twice-weekly sessions of E/RP without D-Cycloserine. DCS was not administered to this group during the active study period.
11023761|NCT01172873|OG000|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
11023762|NCT01172873|OG001|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
11023763|NCT01172873|EG000|Reported Event|D-cycloserine + E/RP|Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held.
11023764|NCT01172873|EG001|Reported Event|E/RP Alone (no DCS Administration)|Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
11023765|NCT01172938|BG000|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
11023766|NCT01172938|BG001|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
11023767|NCT01172938|BG002|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
11023768|NCT01172938|BG003|Baseline|Total|Total of all reporting groups
11023769|NCT01172938|FG000|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
11023770|NCT01172938|FG001|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
11023771|NCT01172938|FG002|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
11023772|NCT01172938|FG003|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years. After 30 mg apremilast BID was identified as the optimal dose, all active participants originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose for these participants.
11023773|NCT01172938|FG004|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years. After 30 mg apremilast BID was identified as the optimal dose, all active participants originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose for these participants.
11023774|NCT01172938|FG005|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
11023775|NCT01172938|FG006|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
11023776|NCT01172938|FG007|Participant Flow|Placebo/Apremilast 20 mg (Long-Term Extension)|Participants initially randomized to placebo tablets BID during the placebo controlled phase and were re-randomized to apremilast at Week 16 or Week 24 and continued receiving apremilast 20 mg BID for up to 4.5 years in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active participants originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose.
11023777|NCT01172938|FG008|Participant Flow|Placebo/Apremilast 30 mg (Long-Term Extension)|Participants initially randomized to placebo tablets BID during the placebo controlled phase and were re-randomized to apremilast 30 mg tablets BID at Week 16 or Week 24 and continued receiving apremilast 30 mg BID for up to 4.5 years in the active treatment / long-term safety phase.
11023778|NCT01172938|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
11023779|NCT01172938|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
11023780|NCT01172938|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
11023781|NCT01172938|OG000|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
11023782|NCT01172938|OG001|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
11023783|NCT01172938|OG002|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
11023784|NCT01172938|OG003|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
11023785|NCT01172938|OG000|Outcome|Apremilast 20 mg (Pre-switch)|Participants randomized or re-randomized to apremilast 20 mg BID and then switched to apremilast 30 mg BID (n = 87, dose switches occurring between Weeks 211 to 249). Only the TEAEs that occurred during apremilast 20 mg BID treatment were counted.
11341325|NCT03681353|OG000|Outcome|Reduced Use Condition|"This arm includes six weeks of mobile contingency management treatment administered via a smart-phone based application (mobile CM), in which participants are provided monetary reinforcement for reducing cannabis use.~Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use."
11023786|NCT01172938|OG001|Outcome|Apremilast 20 mg/30 mg BID (Post-switch)|Participants who switched from apremilast 20 mg BID to apremilast 30 mg BID. Only the TEAEs that occurred during APR 30 mg BID treatment were counted.
11023787|NCT01172938|OG002|Outcome|Apremilast 30 mg BID|Participants who were treated with apremilast 30 mg BID throughout the study regardless of when their apremilast-exposure started (at Weeks 0, 16, or 24).
11023788|NCT01172938|EG000|Reported Event|Week 0-24: Placebo (Placebo-Controlled Phase)|Subjects received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for subjects who escaped early, and through Week 24 for all other subjects.
11023789|NCT01172938|EG001|Reported Event|Week 0-24: Apremilast 20 mg (Placebo- Controlled Phase)|Subjects received 20 mg apremilast tablets PO BID during the 24-week placebo-controlled phase.
11023790|NCT01172938|EG002|Reported Event|Week 0-24: Apremilast 30 mg (Placebo- Controlled Phase)|Subjects received 30 mg apremilast tablets PO BID during the 24-week placebo-controlled phase.
11023791|NCT01172938|EG003|Reported Event|Active Exposure up to 5 Years: Apremilast 20 mg|Subjects received 20 mg apremilast tablets BID at Week 0, and subjects initially received placebo tablets BID during the placebo controlled phase and were re-randomized and received apremilast 20 mg at Week 16 or Week 24 and continued to receive apremilast 20 mg BID for up to 4.5 years in the active treatment / long-term safety phase. Includes data which were occurring under 20 mg BID treatment.
11023792|NCT01172938|EG004|Reported Event|Active Exposure Up to 5 Years: Apremilast 20/30 mg BID|Subjects switched from apremilast 20 mg to apremilast 30 mg PO BID after identification of the optimal dose. Includes data which were occurring under 30 mg BID treatment
11023793|NCT01172938|EG005|Reported Event|Active Exposure up to 5 Years: Apremilast 30 mg BID|Subjects received 30 mg apremilast tablets BID at Week 0, and initially received placebo tablets BID during the placebo controlled phase and were re-randomized and received apremilast 30 mg at Week 16 or Week 24 and continued receiving apremilast 30 mg BID for up to 4.5 years in the active treatment / long-term safety phase.
11023794|NCT01173016|BG000|Baseline|Laronidase After Transplantation|"Patients with Mucopolysaccharidosis type IH (MPS I, Hurler syndrome) treated with a prior allogeneic transplant >2 years previously and treated with Laronidase weekly for 2 years after transplant.~Laronidase: Laronidase 0.58 mg/kg intravenously (IV) once a week for a maximum of 2 years"
11023795|NCT01173016|FG000|Participant Flow|Laronidase After Transplantation|"Patients with Mucopolysaccharidosis type IH (MPS I, Hurler syndrome) treated with a prior allogeneic transplant >2 years previously and treated with Laronidase weekly for 2 years after transplant.~Laronidase: Laronidase 0.58 mg/kg intravenously (IV) once a week for a maximum of 2 years"
11023796|NCT01173016|OG000|Outcome|Laronidase After Transplantation|"Patients with Mucopolysaccharidosis type IH (MPS I, Hurler syndrome) treated with a prior allogeneic transplant >2 years previously and treated with Laronidase weekly for 2 years after transplant.~Laronidase: Laronidase 0.58 mg/kg intravenously (IV) once a week for a maximum of 2 years"
11023797|NCT01173016|EG000|Reported Event|Laronidase After Transplantation|"Patients with Mucopolysaccharidosis type IH (MPS I, Hurler syndrome) treated with a prior allogeneic transplant >2 years previously and treated with Laronidase weekly for 2 years after transplant.~Laronidase: Laronidase 0.58 mg/kg intravenously (IV) once a week for a maximum of 2 years"
11023798|NCT01173029|BG000|Baseline|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
11023799|NCT01173029|BG001|Baseline|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
11023800|NCT01173029|BG002|Baseline|Total|Total of all reporting groups
11023801|NCT01173029|FG000|Participant Flow|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
11023802|NCT01173029|FG001|Participant Flow|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
11023803|NCT01173029|OG000|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
11023804|NCT01173029|OG001|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
11023805|NCT01173029|OG000|Outcome|Polygenic Score: Zero|Sum of the weights for analyzing polymorphisms equal to zero.
11023806|NCT01173029|OG001|Outcome|Polygenic Score: One|Sum of the weights for analyzing polymorphisms equal to one.
11023807|NCT01173029|OG002|Outcome|Polygenic Score: Two|Sum of the weights for analyzing polymorphisms equal to two.
11023808|NCT01173029|OG003|Outcome|Polygenic Score: Three|Sum of the weights for analyzing polymorphisms equal to three.
11023809|NCT01173029|OG004|Outcome|Polygenic Score: Four|Sum of the weights for analyzing polymorphisms equal to four.
11023810|NCT01173029|OG005|Outcome|Polygenic Score: Five|Sum of the weights for analyzing polymorphisms equal to five.
11023811|NCT01173029|OG006|Outcome|Polygenic Score: Six|Sum of the weights for analyzing polymorphisms equal to six.
11023812|NCT01173029|OG007|Outcome|Polygenic Score: Seven|Sum of the weights for analyzing polymorphisms equal to seven.
11023813|NCT01173029|OG008|Outcome|Polygenic Score: Eight|Sum of the weights for analyzing polymorphisms equal to eight.
11023814|NCT01173029|EG000|Reported Event|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
11023815|NCT01173029|EG001|Reported Event|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
11023816|NCT01173055|BG000|Baseline|Milnacipran First, Then Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
11023817|NCT01173055|BG001|Baseline|Placebo First, Then Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
11023818|NCT01173055|BG002|Baseline|Total|Total of all reporting groups
11023819|NCT01173055|FG000|Participant Flow|Milnacipran First, Then Placebo|"Milnacipran then placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Milnacipran First, Then Placebo: Period 1 (Day 1-49); Milnacipran 12.5mg by mouth (PO) Day 1; 12.5mg twice daily (BID) Day 2 to 3; 25mg BID Day 4 to 7; 50mg BID Day 8-14; 100mg BID Day 15-42 followed by taper Day 43-49 and a 14 day washout period. Then, placebo matching study treatment in similar pattern to Period 1 was administered beginning Period 2 (Day 64-112)."
11023820|NCT01173055|FG001|Participant Flow|Placebo First, Then Milnacipran|"Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo First, Then Milnacipran: Period 1 (Day 1-49); Placebo matching study treatment was administered beginning Period 1 (Day 1-49) and a 14 day washout period. Then, Milnacipran Period 2 (Day 64-112); Milnacipran 12.5mg Day 62; 12.5mg twice daily (BID) Day 65 to 66; 25mg BID Day 67 to 70; 50mg BID Day 71-77; 100mg BID Day 78-105 followed by taper Day 106-112."
11023821|NCT01173055|OG000|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
11023822|NCT01173055|OG001|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
11023823|NCT01173055|EG000|Reported Event|Milnacipran|Milnacipran was given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
11023824|NCT01173055|EG001|Reported Event|Placebo|Placebo was given orally twice daily in tablet form at different times during the course of the study.
11023825|NCT01173120|BG000|Baseline|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
11023826|NCT01173120|FG000|Participant Flow|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
11023827|NCT01173120|OG000|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
11023828|NCT01173120|OG000|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
11148711|NCT01866410|OG000|Outcome|Cabozantinib-s-malate, Erlotinib Hydrochloride, T790M Positive|"Patients will receive (A) XL184 (cabozantinib) at 40-mg p.o. daily plus erlotinib at 150-mg p.o. daily in 4-week cycles. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients had positive T790M status in tissue\blood.~Cabozantinib S-malate: Given PO~Erlotinib Hydrochloride: Given PO"
11148712|NCT01866410|OG001|Outcome|Cabozantinib-s-malate, Erlotinib Hydrochloride, T790M Negative|"Patients will receive (A) XL184 (cabozantinib) at 40-mg p.o. daily plus erlotinib at 150-mg p.o. daily in 4-week cycles. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients had negative T790M status in tissue\blood.~Cabozantinib S-malate: Given PO~Erlotinib Hydrochloride: Given PO"
11148713|NCT01866410|OG002|Outcome|Cabozantinib-s-malate, Erlotinib Hydrochloride, T790M Unknown|"Patients will receive (A) XL184 (cabozantinib) at 40-mg p.o. daily plus erlotinib at 150-mg p.o. daily in 4-week cycles. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients had unknown T790M status in tissue\blood.~Cabozantinib S-malate: Given PO~Erlotinib Hydrochloride: Given PO"
11148714|NCT01866410|EG000|Reported Event|Cabozantinib-s-malate, Erlotinib Hydrochloride|"Patients will receive (A) XL184 (cabozantinib) at 40-mg p.o. daily plus erlotinib at 150-mg p.o. daily in 4-week cycles. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Erlotinib Hydrochloride: Given PO"
11148715|NCT01866423|BG000|Baseline|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
11148716|NCT01866423|FG000|Participant Flow|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID (twice a day) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
11148717|NCT01866423|OG000|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
11148718|NCT01866423|EG000|Reported Event|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
11148719|NCT01866592|BG000|Baseline|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
11148720|NCT01866592|FG000|Participant Flow|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
11148721|NCT01866592|OG000|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
11148722|NCT01866592|EG000|Reported Event|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
11148723|NCT01866826|BG000|Baseline|All Participants|All human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
11148724|NCT01866826|FG000|Participant Flow|Rifaximin, Then Placebo|"Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.~Subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily) for 4 weeks, followed by a 4-6 week washout period, and then will receive three capsules of placebo by mouth twice daily for 4 weeks."
11148725|NCT01866826|FG001|Participant Flow|Placebo, Then Rifaximin|"HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design. Placebo~Subject will receive three capsules of placebo by mouth twice daily for 4 weeks, followed by a 4-6 week washout period, and then will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily) for 4 weeks."
11148726|NCT01866826|OG000|Outcome|Rifaximin|"Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.~Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily)."
11148727|NCT01866826|OG001|Outcome|Placebo|"HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.~Placebo: Subject will receive three capsules of placebo by mouth twice daily."
11148728|NCT01866826|EG000|Reported Event|Rifaximin|"Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.~Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily)."
10849759|NCT00298038|EG000|Reported Event|Rifaximin|Participants were administered a single rifaximin 550 mg tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
11023829|NCT01173120|OG000|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous abatacept via the ACP for the duration of the substudy. Abatacept was administered subcutaneously using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
11023830|NCT01173120|EG000|Reported Event|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
11023831|NCT01173159|BG000|Baseline|Omegaven|"Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require TPN or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.~Omegaven: For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site."
11023832|NCT01173159|FG000|Participant Flow|Omegaven|"Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.~Omegaven: For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site."
11023833|NCT01173159|OG000|Outcome|Omegaven|"Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require TPN or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.~Omegaven: For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site."
11023834|NCT01173159|EG000|Reported Event|Omegaven|"Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require TPN or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.~Omegaven: For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site."
11023835|NCT01173211|BG000|Baseline|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
11023836|NCT01173211|BG001|Baseline|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
11023837|NCT01173211|BG002|Baseline|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
11023838|NCT01173211|BG003|Baseline|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
11023839|NCT01173211|BG004|Baseline|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
11023840|NCT01173211|BG005|Baseline|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
11023841|NCT01173211|BG006|Baseline|Total|Total of all reporting groups
11023842|NCT01173211|FG000|Participant Flow|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
11023843|NCT01173211|FG001|Participant Flow|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
11023844|NCT01173211|FG002|Participant Flow|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
11023845|NCT01173211|FG003|Participant Flow|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
11023846|NCT01173211|FG004|Participant Flow|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
11023847|NCT01173211|FG005|Participant Flow|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
11023848|NCT01173211|OG000|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
11023849|NCT01173211|OG001|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
11023850|NCT01173211|OG002|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
11023851|NCT01173211|OG003|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
11023852|NCT01173211|OG004|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
11023853|NCT01173211|OG005|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
11023854|NCT01173211|EG000|Reported Event|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
11023855|NCT01173211|EG001|Reported Event|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
11023856|NCT01173211|EG002|Reported Event|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
11023857|NCT01173211|EG003|Reported Event|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
11023858|NCT01173211|EG004|Reported Event|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
11023859|NCT01173211|EG005|Reported Event|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
11023860|NCT01173471|BG000|Baseline|Placebo OD|Placebo once daily
11023861|NCT01173471|BG001|Baseline|AZD4017 200 mg OD|AZD4017 200 mg once daily
11023862|NCT01173471|BG002|Baseline|Placebo BID|Placebo twice daily
11023863|NCT01173471|BG003|Baseline|AZD4017 400 mg BID|AZD4017 400 mg twice daily
11023864|NCT01173471|BG004|Baseline|Total|Total of all reporting groups
11023865|NCT01173471|FG000|Participant Flow|Placebo OD|Placebo once daily
11023866|NCT01173471|FG001|Participant Flow|AZD4017 200 mg OD|AZD4017 200 mg once daily
11023867|NCT01173471|FG002|Participant Flow|Placebo BID|Placebo twice daily
11023868|NCT01173471|FG003|Participant Flow|AZD4017 400 mg BID|AZD4017 400 mg twice daily
11023869|NCT01173471|OG000|Outcome|Placebo OD|Placebo once daily
11023870|NCT01173471|OG001|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
11023871|NCT01173471|OG002|Outcome|Placebo BID|Placebo twice daily
11023872|NCT01173471|OG003|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
11023873|NCT01173471|EG000|Reported Event|Placebo OD|Placebo once daily
11023874|NCT01173471|EG001|Reported Event|AZD4017 200 mg OD|AZD4017 200 mg once daily
11023875|NCT01173471|EG002|Reported Event|Placebo BID|Placebo twice daily
11023876|NCT01173471|EG003|Reported Event|AZD4017 400 mg BID|AZD4017 400 mg twice daily
11023877|NCT01173523|BG000|Baseline|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
11023878|NCT01173523|BG001|Baseline|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
11023879|NCT01173523|BG002|Baseline|Total|Total of all reporting groups
11023880|NCT01173523|FG000|Participant Flow|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
11023881|NCT01173523|FG001|Participant Flow|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
11023882|NCT01173523|OG000|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
11023883|NCT01173523|OG001|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
11023884|NCT01173523|EG000|Reported Event|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
11023885|NCT01173523|EG001|Reported Event|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
11023886|NCT01173601|BG000|Baseline|12 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11023887|NCT01173601|BG001|Baseline|18 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
11023888|NCT01173601|BG002|Baseline|Placebo + SSRI (Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
11023889|NCT01173601|BG003|Baseline|Placebo + SSRI (Non-Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
11023890|NCT01173601|BG004|Baseline|Total|Total of all reporting groups
11023891|NCT01173601|FG000|Participant Flow|Placebo + SSRI (Pre-Randomized Participants)|Placebo: Administered orally, once daily for 3 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
11023892|NCT01173601|FG001|Participant Flow|12 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI
11023893|NCT01173601|FG002|Participant Flow|18 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
11023894|NCT01173601|FG003|Participant Flow|Placebo + SSRI (Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
11023895|NCT01173601|FG004|Participant Flow|Placebo + SSRI (Non-Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks
11023896|NCT01173601|OG000|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11023897|NCT01173601|OG001|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
11023898|NCT01173601|OG002|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
11023899|NCT01173601|OG000|Outcome|LY2216684 + SSRI|LY2216684: fixed doses of 12 milligrams (mg) administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) or 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
11023900|NCT01173601|EG000|Reported Event|Placebo + SSRI (Pre-randomized) CF Phase|"Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all enrolled participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Confirmation (CF) Phase."
11023901|NCT01173601|EG001|Reported Event|12 mg LY2216684 + SSRI (Randomized) AT Phase|"LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11023902|NCT01173601|EG002|Reported Event|18 mg LY2216684 + SSRI (Randomized) AT Phase|"LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11023903|NCT01173601|EG003|Reported Event|Placebo + SSRI (Randomized) AT Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11023904|NCT01173601|EG004|Reported Event|Placebo + SSRI (Non-randomized) AT Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes all non-randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11023905|NCT01173601|EG005|Reported Event|Placebo + SSRI (Pre-randomized) Discontinuation Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11023906|NCT01173601|EG006|Reported Event|12 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)|"LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11023907|NCT01173601|EG007|Reported Event|12 mg LY2216684 + SSRI (Taper Discontinuation Phase)|"LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI~Includes all randomized participants who tapered discontinuation of LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11023908|NCT01173601|EG008|Reported Event|18 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)|"LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11023909|NCT01173601|EG009|Reported Event|18 mg LY2216684 + SSRI (Taper Discontinuation Phase)|"LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase~Includes all randomized participants who tapered discontinuation of LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11023910|NCT01173601|EG010|Reported Event|Placebo + SSRI (Randomized) Discontinuation Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes all randomized participants who discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11023911|NCT01173601|EG011|Reported Event|Placebo + SSRI (Non-randomized) Discontinuation Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes all non-randomized participants who discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11023912|NCT01173653|BG000|Baseline|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
11023913|NCT01173653|BG001|Baseline|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
10849760|NCT00298038|EG001|Reported Event|Placebo|Participants were administered a single matching placebo tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
11023914|NCT01173653|BG002|Baseline|Total|Total of all reporting groups
11023915|NCT01173653|FG000|Participant Flow|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
11023916|NCT01173653|FG001|Participant Flow|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
11023917|NCT01173653|OG000|Outcome|Control Arm|No intervention given to this ED population of smokers
11023918|NCT01173653|OG001|Outcome|Intervention Arm|Enrollees put in contact with 1-800-QUIT-NOW line
11023919|NCT01173653|EG000|Reported Event|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
11023920|NCT01173653|EG001|Reported Event|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
11023921|NCT01173679|BG000|Baseline|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
11023922|NCT01173679|FG000|Participant Flow|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
11023923|NCT01173679|OG000|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm, open-label~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
11023924|NCT01173679|OG000|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
11023925|NCT01173679|EG000|Reported Event|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
11023926|NCT01173692|BG000|Baseline|Minocycline|Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
11023927|NCT01173692|BG001|Baseline|Placebo|Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
11023928|NCT01173692|BG002|Baseline|Total|Total of all reporting groups
11023929|NCT01173692|FG000|Participant Flow|Minocycline|Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
11023930|NCT01173692|FG001|Participant Flow|Placebo|Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
11023931|NCT01173692|OG000|Outcome|Minocycline|Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
11023932|NCT01173692|OG001|Outcome|Placebo|Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
11023933|NCT01173692|EG000|Reported Event|Minocycline|Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
11023934|NCT01173692|EG001|Reported Event|Placebo|Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
11023935|NCT01173718|BG000|Baseline|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
11023936|NCT01173718|FG000|Participant Flow|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
11023937|NCT01173718|OG000|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
11023938|NCT01173718|EG000|Reported Event|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft
11023939|NCT01173848|BG000|Baseline|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
11023940|NCT01173848|BG001|Baseline|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
11023941|NCT01173848|BG002|Baseline|Total|Total of all reporting groups
11023942|NCT01173848|FG000|Participant Flow|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
11023943|NCT01173848|FG001|Participant Flow|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
11023944|NCT01173848|OG000|Outcome|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
11023945|NCT01173848|OG001|Outcome|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
11023946|NCT01173848|EG000|Reported Event|Vitamin D2 and Vitamin D3|"Adverse Events were not logged by study arms.~Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months~or~Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
11023947|NCT01173874|BG000|Baseline|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
11023948|NCT01173874|BG001|Baseline|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
11023949|NCT01173874|BG002|Baseline|Total|Total of all reporting groups
11023950|NCT01173874|FG000|Participant Flow|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
11023951|NCT01173874|FG001|Participant Flow|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
11066292|NCT01391507|BG000|Baseline|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066293|NCT01391507|BG001|Baseline|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066294|NCT01391507|BG002|Baseline|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066295|NCT01391507|BG003|Baseline|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11023952|NCT01173874|OG000|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
11023953|NCT01173874|OG001|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
11023954|NCT01173874|EG000|Reported Event|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
11023955|NCT01173874|EG001|Reported Event|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
11023956|NCT01174004|BG000|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
11023957|NCT01174004|BG001|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
11023958|NCT01174004|BG002|Baseline|Total|Total of all reporting groups
11023959|NCT01174004|FG000|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
11023960|NCT01174004|FG001|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
11023961|NCT01174004|OG000|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
11023962|NCT01174004|OG001|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
11023963|NCT01174004|EG000|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
11023964|NCT01174004|EG001|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
11023965|NCT01174030|BG000|Baseline|CD07805/47 Gel 0.5% QD|
11023966|NCT01174030|BG001|Baseline|CD07805/47 Gel 0.18% QD|
11023967|NCT01174030|BG002|Baseline|CD07805/47 Gel 0.18% BID|
11023968|NCT01174030|BG003|Baseline|Vehicle Gel QD|
11023969|NCT01174030|BG004|Baseline|Vehicle Gel BID|
11023970|NCT01174030|BG005|Baseline|Total|Total of all reporting groups
11023971|NCT01174030|FG000|Participant Flow|CD07805/47 Gel 0.5% QD|CD07805/47 Gel 0.5% Once Daily
11023972|NCT01174030|FG001|Participant Flow|CD07805/47 Gel 0.18% QD|CD07805/47 Gel 0.18% Once Daily
11023973|NCT01174030|FG002|Participant Flow|CD07805/47 Gel 0.18% BID|CD07805/47 Gel 0.18% Twice Daily
11023974|NCT01174030|FG003|Participant Flow|Vehicle Gel QD|Vehicle Gel Once Daily
11023975|NCT01174030|FG004|Participant Flow|Vehicle Gel BID|Vehicle Gel Twice Daily
11023976|NCT01174030|OG000|Outcome|CD07805/47 Gel 0.5% QD|
11023977|NCT01174030|OG001|Outcome|CD07805/47 Gel 0.18% QD|
11023978|NCT01174030|OG002|Outcome|CD07805/47 Gel 0.18% BID|
11023979|NCT01174030|OG003|Outcome|Vehicle Gel QD|
11023980|NCT01174030|OG004|Outcome|Vehicle Gel BID|
11023981|NCT01174030|EG000|Reported Event|CD07805/47 Gel 0.5% QD|
11023982|NCT01174030|EG001|Reported Event|CD07805/47 Gel 0.18% QD|
11023983|NCT01174030|EG002|Reported Event|CD07805/47 Gel 0.18% BID|
11023984|NCT01174030|EG003|Reported Event|Vehicle Gel QD|
11023985|NCT01174030|EG004|Reported Event|Vehicle Gel BID|
11023986|NCT01174043|BG000|Baseline|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
11023987|NCT01174043|FG000|Participant Flow|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
11023988|NCT01174043|OG000|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
11023989|NCT01174043|EG000|Reported Event|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
11023990|NCT01174082|BG000|Baseline|Recipient|Vaccine + DLI
11023991|NCT01174082|BG001|Baseline|Donor|Vaccine
11023992|NCT01174082|BG002|Baseline|Total|Total of all reporting groups
11023993|NCT01174082|FG000|Participant Flow|Recipient|Vaccine + DLI
11023994|NCT01174082|FG001|Participant Flow|Donor|Vaccine
11023995|NCT01174082|OG000|Outcome|Recipient|Vaccine + DLI
11023996|NCT01174082|OG001|Outcome|Donor|Vaccine
11023997|NCT01174082|EG000|Reported Event|Recipient|KLH vaccine + DLI
11023998|NCT01174082|EG001|Reported Event|Donor|KLH vaccine
11023999|NCT01174160|BG000|Baseline|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
11024000|NCT01174160|BG001|Baseline|Placebo|"placebo~Up to two 10-min infusions of normal saline"
11024001|NCT01174160|BG002|Baseline|Total|Total of all reporting groups
11024002|NCT01174160|FG000|Participant Flow|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
11024003|NCT01174160|FG001|Participant Flow|Placebo|"placebo~Up to two 10-min infusions of normal saline"
11066296|NCT01391507|BG004|Baseline|Total|Total of all reporting groups
11024004|NCT01174160|OG000|Outcome|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
11024005|NCT01174160|OG001|Outcome|Placebo|"placebo~Up to two 10-min infusions of normal saline"
11024006|NCT01174160|EG000|Reported Event|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
11024007|NCT01174160|EG001|Reported Event|Placebo|"placebo~Up to two 10-min infusions of normal saline"
11024008|NCT01174173|BG000|Baseline|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
11024009|NCT01174173|FG000|Participant Flow|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
11024010|NCT01174173|OG000|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
11024011|NCT01174173|OG000|Outcome|Ranolazine 1000 mg po Bid|MRI was not analyzable due to inability of patients to undergo MRI due to technical issues
11024012|NCT01174173|EG000|Reported Event|Ranolazine|Ranolazine: ranolazine 1000 mg PO BID for 3 months
11024013|NCT01174186|BG000|Baseline|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
11024014|NCT01174186|BG001|Baseline|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
11024015|NCT01174186|BG002|Baseline|Total|Total of all reporting groups
11024016|NCT01174186|FG000|Participant Flow|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
11024017|NCT01174186|FG001|Participant Flow|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
11024018|NCT01174186|OG000|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
11024019|NCT01174186|OG001|Outcome|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
11024020|NCT01174186|EG000|Reported Event|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
11024021|NCT01174186|EG001|Reported Event|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
11024022|NCT01174238|BG000|Baseline|Axitinib+Carboplatin/Paclitaxel, Including FLT-PET Patients|"Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy~Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase~Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.~6 patients in this group received drug treatment and in addition underwent FLT-PET during first treatment cycle."
11024023|NCT01174238|FG000|Participant Flow|Axitinib + Carboplatin/Paclitaxel|"Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy~Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase~Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase."
11024024|NCT01174238|OG000|Outcome|Axitinib + Carboplatin/Paclitaxel|"All enrolled patients received the same treatment with study drugs axitinib, carboplatin, and paclitaxel and had tumor imaging assessments: PET-CT, CT Scan, and/or MRI. 6 of 38 patients were selected to undergo FLT-PET scans.~1 treatment cycle: 21 days~dual therapy: 5mg Axitinib on days 1-14, twice a day (BID)~monotherapy: if patient completes ≥ 6 cycles, 5mg Axitinib every day, once a day (QD)~Carboplatin: Day 1 of each treatment cycle in combination with paclitaxel if patients are in dual therapy phase~Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients in dual therapy phase."
11024025|NCT01174238|OG000|Outcome|Axitinib + Carboplatin/Paclitaxel With FLT-PET Scans|"Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy~Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase~Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase."
10849761|NCT00298090|BG000|Baseline|StO2 Values|StO2 values pre and post arterial line placement.
11024026|NCT01174238|OG000|Outcome|Axitinib+Carboplatin/Paclitaxel, Including FLT-PET Patients|"Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy~Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase~Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.~6 patients underwent FLT-PET during first treatment cycle."
11024027|NCT01174238|EG000|Reported Event|Axitinib + Carboplatin/Paclitaxel|"Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy~Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase~Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase."
11024028|NCT01174238|EG001|Reported Event|Axitinib + Carboplatin/Paclitaxel and With FLT-PET Scans|"Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy~Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase~Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.~FLT-PET during first treatment cycle."
11024029|NCT01174264|BG000|Baseline|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose of vismodegib PO on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024030|NCT01174264|BG001|Baseline|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024031|NCT01174264|BG002|Baseline|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024032|NCT01174264|BG003|Baseline|Total|Total of all reporting groups
11024033|NCT01174264|FG000|Participant Flow|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024034|NCT01174264|FG001|Participant Flow|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024035|NCT01174264|FG002|Participant Flow|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024036|NCT01174264|OG000|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024037|NCT01174264|OG001|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024038|NCT01174264|OG002|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024039|NCT01174264|EG000|Reported Event|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024040|NCT01174264|EG001|Reported Event|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024041|NCT01174264|EG002|Reported Event|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
11024042|NCT01174342|BG000|Baseline|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
11024043|NCT01174342|FG000|Participant Flow|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
11024044|NCT01174342|OG000|Outcome|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery
11024045|NCT01174342|EG000|Reported Event|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
11024046|NCT01174446|BG000|Baseline|All Study Participants Who Received Study Drug|BAX326 : -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX -Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only -Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1
11024047|NCT01174446|FG000|Participant Flow|PK (BAX326 Then BeneFIX) Then Prophylaxis Then PK BAX326 Only|-Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 (75 ± 5 IU/kg) then BeneFIX (75 ± 5 IU/kg). -Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only -Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1
11024048|NCT01174446|FG001|Participant Flow|PK (BeneFIX Then BAX326) Then Prophylaxis Then PK BAX326 Only|-Study Part 1: Pharmacokinetic (PK) Crossover with BeneFIX (75 ± 5 IU/kg) then BAX326 (75 ± 5 IU/kg). -Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only -Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1
11024049|NCT01174446|FG002|Participant Flow|Study Part 2 Only: BAX326 Prophylaxis|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
11024050|NCT01174446|FG003|Participant Flow|Study Part 2 Only: BAX326 On-Demand|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
11024051|NCT01174446|OG000|Outcome|BAX326|
11024052|NCT01174446|OG001|Outcome|BeneFIX|
11024053|NCT01174446|OG000|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
11024054|NCT01174446|OG001|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
11024055|NCT01174446|OG002|Outcome|Study Part 3: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)
11024056|NCT01174446|OG000|Outcome|Part 1 or Part 2, ED 1|PK infusion with BAX326 at 75 ± 5 IU/kg
11024057|NCT01174446|OG001|Outcome|Part 2: Week 5|PK infusion with BeneFIX at 75 ± 5 IU/kg
11024058|NCT01174446|OG002|Outcome|Part 2: Week 13|PK infusion with BAX326 at 75 ± 5 IU/kg Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)
11024059|NCT01174446|OG003|Outcome|Part 2 or Part 3: Week 26|
11024060|NCT01174446|OG004|Outcome|Study Completion or Termination Visit|
10886639|NCT00495469|OG001|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886640|NCT00495469|OG002|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886641|NCT00495469|OG003|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886642|NCT00495469|OG004|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886643|NCT00495469|OG005|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
10886644|NCT00495469|OG006|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
10886645|NCT00495469|OG000|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
10886646|NCT00495469|OG001|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886647|NCT00495469|OG002|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886648|NCT00495469|OG003|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
11024061|NCT01174446|OG000|Outcome|Part 2: Week 5|PK infusion with BAX326 at 75 ± 5 IU/kg
11024062|NCT01174446|OG001|Outcome|Part 2: Week 13|
10886649|NCT00495469|OG004|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886650|NCT00495469|OG005|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
10886651|NCT00495469|OG006|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
10886652|NCT00495469|EG000|Reported Event|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
10886653|NCT00495469|EG001|Reported Event|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886654|NCT00495469|EG002|Reported Event|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
11024063|NCT01174446|OG002|Outcome|Part 2 or Part 3: Week 26|
10886655|NCT00495469|EG003|Reported Event|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886656|NCT00495469|EG004|Reported Event|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
10886657|NCT00495469|EG005|Reported Event|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
10886658|NCT00495469|EG006|Reported Event|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
10886659|NCT00495495|BG000|Baseline|Ozone Treatment/Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
10886660|NCT00495495|FG000|Participant Flow|Ozone Treatment and Placebo Treatment|60-second Ozone device treatment compared to 60-second Placebo device treatment. Study utilized split-mouth design. The paired treatment assignment for the two teeth within each subject was performed according to a randomization table provided by the Biometrician. Randomization of teeth to Ozone treatment or Placebo treatment was stratifed according to tooth similarity.
10886661|NCT00495495|OG000|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
10886662|NCT00495495|OG001|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
11024064|NCT01174446|OG003|Outcome|Study Completion or Termination Visit|
11024065|NCT01174446|OG000|Outcome|BAX326 Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required. Participants received a minimum of three months prophylactic treatment
11024066|NCT01174446|OG000|Outcome|Bleeding Site: Target Joint|
11024067|NCT01174446|OG001|Outcome|Bleeding Site: Non-Target Joint|
11024068|NCT01174446|OG002|Outcome|Bleeding Site: All Joint|
11024069|NCT01174446|OG003|Outcome|Bleeding Site: Non-Joint|
11024070|NCT01174446|OG004|Outcome|Bleeding Cause: Spontaneous|
11024071|NCT01174446|OG005|Outcome|Bleeding Cause: Injury|
11024072|NCT01174446|OG006|Outcome|Bleeding Cause: Unknown|
11024073|NCT01174446|OG000|Outcome|Prophylactic Treatment|
11024074|NCT01174446|OG001|Outcome|Bleeding Treatment|Includes all participants who received any infusions for bleeding treatment in the Full Analysis Set. (ie includes all On-demand arm (N=14) and 33 participants from the prophylaxis arm who experienced a bleeding episode)
11024075|NCT01174446|OG000|Outcome|Prophylaxis|Study Part 2 Only
11024076|NCT01174446|OG001|Outcome|On-Demand|Study Part 2 Only
11024077|NCT01174446|OG000|Outcome|All Study Participants|
11024078|NCT01174446|OG000|Outcome|AEs - Not Related|
11024079|NCT01174446|OG001|Outcome|AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
11024080|NCT01174446|OG000|Outcome|Participants With AEs - Not Related|
11024081|NCT01174446|OG001|Outcome|Participants With AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
11024082|NCT01174446|OG000|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
11024083|NCT01174446|OG001|Outcome|Prophylaxis: End of Study|
11024084|NCT01174446|OG002|Outcome|Prophylaxis: Change From Baseline|
11024085|NCT01174446|OG003|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|On-Demand Dosing and Frequency (Guidance): • Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved • More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved • Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves Required dose calculated using IR determined of first 16 participants who completed Part 1 according to: Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery} Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by: Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg Amount administered & frequency should be oriented to individual clinical effectiveness
11024086|NCT01174446|OG004|Outcome|On-Demand: End of Study|
11024087|NCT01174446|OG005|Outcome|On-Demand: Change From Baseline|
11024088|NCT01174446|OG000|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
11024089|NCT01174446|OG003|Outcome|On-Demand: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|On-Demand Dosing and Frequency (Guidance): • Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved • More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved • Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves Required dose calculated using IR determined of first 16 participants who completed Part 1 according to: Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery} Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by: Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg Amount administered & frequency should be oriented to individual clinical effectiveness
11024090|NCT01174446|OG000|Outcome|Part 1 or Part 2, Exposure Day 1 (Baseline)|
11024091|NCT01174446|OG001|Outcome|End of Study|
11024092|NCT01174446|OG002|Outcome|Change From Baseline|
11024093|NCT01174446|OG000|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
11024094|NCT01174446|OG001|Outcome|On-Demand|On-Demand Dosing and Frequency (Guidance): • Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved • More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved • Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves Required dose calculated using IR determined of first 16 participants who completed Part 1 according to: Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery} Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by: Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg Amount administered & frequency should be oriented to individual clinical effectiveness
11024095|NCT01174446|EG000|Reported Event|BAX326|BAX326: -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX •Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only •Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1
11024096|NCT01174459|BG000|Baseline|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
11024097|NCT01174459|FG000|Participant Flow|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
11024098|NCT01174459|OG000|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
11024099|NCT01174459|EG000|Reported Event|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
11024100|NCT01174550|BG000|Baseline|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
11024101|NCT01174550|BG001|Baseline|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
11024102|NCT01174550|BG002|Baseline|Total|Total of all reporting groups
11024103|NCT01174550|FG000|Participant Flow|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
11024104|NCT01174550|FG001|Participant Flow|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
11024105|NCT01174550|OG000|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
11024106|NCT01174550|OG001|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
11024107|NCT01174550|EG000|Reported Event|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
11024108|NCT01174550|EG001|Reported Event|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
11024109|NCT01174576|BG000|Baseline|Group 1|
11024110|NCT01174576|FG000|Participant Flow|Caffeinated Coffee/Decaffeinated Coffee/Water|"200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight or instant decaffeinated coffee or water. All participants received all interventions without exception in a random order.~Three combinations of treatment sequences were used:~Caffeinated coffee, then decaffeinated coffee, then water~Decaffeinated coffee first, then water, then caffeinated coffee~Water first, then caffeinated coffee, then decaffeinated coffee.~Each treatment was separated by the other by at least one week interval.~The first volunteer entered the study received the first combination, the second volunteer the second combiation, the third volunteer the third combination, the forth volunteer the first combination of treatments, etc."
11024111|NCT01174576|OG000|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
11024112|NCT01174576|OG001|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
11024113|NCT01174576|OG002|Outcome|Water|200 mL
11024114|NCT01174576|OG001|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeineated coffee
11024115|NCT01174576|OG000|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
11024116|NCT01174576|OG001|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
11024117|NCT01174576|OG002|Outcome|Water|200 ml water
11024118|NCT01174576|OG000|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/ kg body weight
11024119|NCT01174576|EG000|Reported Event|Caffeinated Coffee|200 mL, coffee containing 3 mg caffeine/kg body weight
11024120|NCT01174576|EG001|Reported Event|Decaffeinated Coffee|200 mL decaffeinated coffee, same amount as caffeinated coffee
11024121|NCT01174576|EG002|Reported Event|Water|200 mL
11024122|NCT01174784|BG000|Baseline|Enrolled/Primary Cohort|Subjects with a CTO upon presentation to the surgical unit.
11024123|NCT01174784|FG000|Participant Flow|Device Treatment|This is a one-arm study. All subjects will have a CTO addressed by the Wildcat crossing device.
11024124|NCT01174784|OG000|Outcome|Enrolled/Primary Cohort|Patients with 99% to 100% stenosis of a peripheral artery were approached to join the study.
11024125|NCT01174784|OG000|Outcome|Enrolled/Primary Cohort|Single arm in which the device was used
11024126|NCT01174784|EG000|Reported Event|Enrolled/Primary Cohort|Patient with 99% to 100% stenosis of a peripheral artery.
11024127|NCT01174823|BG000|Baseline|Placebo|placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day
11024128|NCT01174823|BG001|Baseline|Bepotastine Besilate Ophthalmic Solution|bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
11024129|NCT01174823|BG002|Baseline|Total|Total of all reporting groups
11024130|NCT01174823|FG000|Participant Flow|Placebo|placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day
11024131|NCT01174823|FG001|Participant Flow|Bepotastine Besilate Ophthalmic Solution|bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
11024132|NCT01174823|OG000|Outcome|Placebo|placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day
11024133|NCT01174823|OG001|Outcome|Bepotastine Besilate Ophthalmic Solution|bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
11024134|NCT01174823|EG000|Reported Event|Placebo|placebo comparator ophthalmic solution: sterile ophthalmic solution
11024135|NCT01174823|EG001|Reported Event|Bepotastine Besilate Ophthalmic Solution|bepotastine besilate ophthalmic solution: sterile ophthalmic solution
11024136|NCT01175005|BG000|Baseline|Fever and a Central Venous Catheter|
11024137|NCT01175005|FG000|Participant Flow|Fever and a Central Venous Catheter|
11024138|NCT01175005|OG000|Outcome|Blood Culture Positive|Procalcitonin level in patients with fever and a CVC with positive blood culture
11024139|NCT01175005|OG001|Outcome|Blood Culture Negative|Procalcitonin level in patients with fever and a CVC with negative blood culture
11024140|NCT01175005|EG000|Reported Event|Fever and a Central Venous Catheter|
11024141|NCT01175018|BG000|Baseline|Anakinra|Anakinra 100 mg injectable subcutaneously daily
11024142|NCT01175018|BG001|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
11024143|NCT01175018|BG002|Baseline|Total|Total of all reporting groups
11024144|NCT01175018|FG000|Participant Flow|Anakinra|Anakinra 100 mg injectable subcutaneously daily
11024145|NCT01175018|FG001|Participant Flow|Placebo|0.67 ml of sodium chloride (NaCl) 0.9% solution
11024146|NCT01175018|OG000|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
11024147|NCT01175018|OG001|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
11024148|NCT01175018|OG000|Outcome|Anakinra|"Anakinra 100 mg injectable subcutaneously daily~Anakinra: Anakinra 100 mg s.c. daily for 14 days"
11024149|NCT01175018|OG001|Outcome|Placebo|"0.67 ml of NaCl 0.9% solution~Placebo: 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days"
11024150|NCT01175018|EG000|Reported Event|Anakinra|Anakinra 100 mg injectable subcutaneously daily
11024151|NCT01175018|EG001|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
11024152|NCT01175031|BG000|Baseline|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
11024153|NCT01175031|FG000|Participant Flow|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
11024154|NCT01175031|OG000|Outcome|REMstar Auto With A-Flex|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).~Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
11024155|NCT01175031|OG001|Outcome|Manually Scored Polysomnography (PSG)|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).~Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
11024156|NCT01175031|OG000|Outcome|Device-Detected Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
11024157|NCT01175031|OG000|Outcome|Device-Detected Obstructive Airway Apneas|Of the device-detected obstructive airway apneas a comparison was done of manually scored verses device detected.
11024158|NCT01175031|OG000|Outcome|Device-Detected Clear Airway Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
11024159|NCT01175031|EG000|Reported Event|Subjects With Sleep Apnea|Subjects aged 21 thru 80 with a diagnosis of CompSAS or OSA and able to undergo a full-night in the sleep laboratory.
11024160|NCT01175083|BG000|Baseline|Tritanrix-HepB/Hib+Polio Sabin <6S Group|Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
11024161|NCT01175083|BG001|Baseline|Tritanrix-HepB/Hib+Polio Sabin <6NS Group|Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
11024162|NCT01175083|BG002|Baseline|Synflorix 7-11S Group|Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024163|NCT01175083|BG003|Baseline|Synflorix 7-11NS Group|Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024164|NCT01175083|BG004|Baseline|Synflorix 12-23S Group|Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024165|NCT01175083|BG005|Baseline|Synflorix 12-23NS Group|Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024166|NCT01175083|BG006|Baseline|Total|Total of all reporting groups
11024167|NCT01175083|FG000|Participant Flow|Tritanrix-HepB/Hib+Polio Sabin <6S Group|Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
11066297|NCT01391507|FG000|Participant Flow|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11024168|NCT01175083|FG001|Participant Flow|Tritanrix-HepB/Hib+Polio Sabin <6NS Group|Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
11024169|NCT01175083|FG002|Participant Flow|Synflorix 7-11S Group|Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024170|NCT01175083|FG003|Participant Flow|Synflorix 7-11NS Group|Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024171|NCT01175083|FG004|Participant Flow|Synflorix 12-23S Group|Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024172|NCT01175083|FG005|Participant Flow|Synflorix 12-23NS Group|Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024173|NCT01175083|OG000|Outcome|Tritanrix-HepB/Hib+Polio Sabin <6S Group|Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
11024174|NCT01175083|OG001|Outcome|Tritanrix-HepB/Hib+Polio Sabin <6NS Group|Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
11024175|NCT01175083|OG000|Outcome|Synflorix 7-11S Group|Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024176|NCT01175083|OG001|Outcome|Synflorix 7-11NS Group|Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024177|NCT01175083|OG000|Outcome|Synflorix 12-23S Group|Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024178|NCT01175083|OG001|Outcome|Synflorix 12-23NS Group|Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024179|NCT01175083|OG002|Outcome|Synflorix 7-11S Group|Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024180|NCT01175083|OG003|Outcome|Synflorix 7-11NS Group|Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024181|NCT01175083|OG004|Outcome|Synflorix 12-23S Group|Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024182|NCT01175083|OG005|Outcome|Synflorix 12-23NS Group|Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024183|NCT01175083|EG000|Reported Event|Tritanrix-HepB/Hib+Polio Sabin <6S Group|Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
11024184|NCT01175083|EG001|Reported Event|Tritanrix-HepB/Hib+Polio Sabin <6NS Group|Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
11024185|NCT01175083|EG002|Reported Event|Synflorix 7-11S Group|Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024186|NCT01175083|EG003|Reported Event|Synflorix 7-11NS Group|Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
11024187|NCT01175083|EG004|Reported Event|Synflorix 12-23S Group|Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024188|NCT01175083|EG005|Reported Event|Synflorix 12-23NS Group|Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
11024189|NCT01175135|BG000|Baseline|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
11024190|NCT01175135|BG001|Baseline|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
11024191|NCT01175135|BG002|Baseline|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
11024192|NCT01175135|BG003|Baseline|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
11024193|NCT01175135|BG004|Baseline|Total|Total of all reporting groups
11024194|NCT01175135|FG000|Participant Flow|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
11024195|NCT01175135|FG001|Participant Flow|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
11024196|NCT01175135|FG002|Participant Flow|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
11024197|NCT01175135|FG003|Participant Flow|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
11024198|NCT01175135|OG000|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
11024199|NCT01175135|OG001|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
11024200|NCT01175135|OG002|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
11024201|NCT01175135|OG003|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
11024202|NCT01175135|EG000|Reported Event|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
11024203|NCT01175135|EG001|Reported Event|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
11024204|NCT01175135|EG002|Reported Event|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
11024205|NCT01175135|EG003|Reported Event|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
11024206|NCT01175148|BG000|Baseline|Recipient Arm|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
11024207|NCT01175148|BG001|Baseline|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
11024208|NCT01175148|BG002|Baseline|Total|Total of all reporting groups
11024209|NCT01175148|FG000|Participant Flow|Recipient Arm|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
11024210|NCT01175148|FG001|Participant Flow|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
11024211|NCT01175148|OG000|Outcome|Recipient Arm - Experimental|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
11024212|NCT01175148|EG000|Reported Event|Recipient Arm - Experimental|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
11024213|NCT01175148|EG001|Reported Event|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
11024214|NCT01175213|BG000|Baseline|Participants Aged 2 to <12 Years|
11024215|NCT01175213|BG001|Baseline|Participants Aged 12 to <16 Years|
11024216|NCT01175213|BG002|Baseline|Participants Aged 16 to <65 Years|
11024217|NCT01175213|BG003|Baseline|Participants Aged 65 Years and Older|
11024218|NCT01175213|BG004|Baseline|Total|Total of all reporting groups
11024219|NCT01175213|FG000|Participant Flow|IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only|Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). Participants then went into a safety follow-up with either SC administration of IGSC, 10% or intravenous (IV) administration of Immune Globulin Intravenous (Human) (IGIV), 10%, only. The IV or SC administration route was at the discretion of the participant and the investigator. Note: IGIV, 10% is the same product as IGSC, 10%.
11024220|NCT01175213|FG001|Participant Flow|IGIV, 10% Only|Participants were treated with Immune Globulin Intravenous (Human) (IGIV), 10% only, via the intravenous (IV) route throughout the study. Note: IGIV, 10% is the same product as IGSC, 10%.
11024221|NCT01175213|OG000|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20.
11024222|NCT01175213|OG000|Outcome|All Participants Treated With rHuPH20 and/or IGSC, 10%|All participants who had been exposed to either or both study drugs in the Safety Analysis Data Set. Study drugs are Immune Globulin Subcutaneous Solution, 10%, (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20). This includes the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20. The 3 participants were treated at 4-week intervals only. Number of participants in each treatment interval [N] is provided.
11024223|NCT01175213|OG000|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
11024224|NCT01175213|OG001|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
11024225|NCT01175213|OG000|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
11024226|NCT01175213|EG000|Reported Event|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
11024227|NCT01175213|EG001|Reported Event|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
11024228|NCT01175226|BG000|Baseline|BTA798|BTA798: BTA798 twice daily
11024229|NCT01175226|BG001|Baseline|Placebo|Placebo: Placebo twice daily
11024230|NCT01175226|BG002|Baseline|Total|Total of all reporting groups
11024231|NCT01175226|FG000|Participant Flow|BTA798|BTA798: BTA798 twice daily
11024232|NCT01175226|FG001|Participant Flow|Placebo|Placebo: Placebo twice daily
11024233|NCT01175226|OG000|Outcome|BTA798|BTA798: BTA798 twice daily
11024234|NCT01175226|OG001|Outcome|Placebo|Placebo: Placebo twice daily
11024235|NCT01175226|EG000|Reported Event|BTA798|BTA798: BTA798 twice daily
11024236|NCT01175226|EG001|Reported Event|Placebo|Placebo: Placebo twice daily
11024237|NCT01175317|BG000|Baseline|Goald-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
11024238|NCT01175317|BG001|Baseline|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
11024239|NCT01175317|BG002|Baseline|Total|Total of all reporting groups
11024240|NCT01175317|FG000|Participant Flow|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
11024241|NCT01175317|FG001|Participant Flow|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
11024242|NCT01175317|OG000|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
11024243|NCT01175317|OG001|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
11024244|NCT01175317|EG000|Reported Event|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
11024245|NCT01175317|EG001|Reported Event|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
11024246|NCT01175343|BG000|Baseline|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11024247|NCT01175343|FG000|Participant Flow|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11024248|NCT01175343|OG000|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11024249|NCT01175343|EG000|Reported Event|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11024250|NCT01175369|BG000|Baseline|Usual Care|Usual asthma care
11024251|NCT01175369|BG001|Baseline|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
11024252|NCT01175369|BG002|Baseline|Total|Total of all reporting groups
11024253|NCT01175369|FG000|Participant Flow|Usual Care|Usual asthma care
11024254|NCT01175369|FG001|Participant Flow|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
11024255|NCT01175369|OG000|Outcome|Usual Care|Usual asthma care
11024256|NCT01175369|OG001|Outcome|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
11024257|NCT01175369|EG000|Reported Event|Usual Care|Usual asthma care
11024258|NCT01175369|EG001|Reported Event|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
11024259|NCT01175382|BG000|Baseline|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
11024260|NCT01175382|BG001|Baseline|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
11024261|NCT01175382|BG002|Baseline|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
11024262|NCT01175382|BG003|Baseline|Total|Total of all reporting groups
11024263|NCT01175382|FG000|Participant Flow|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
11024264|NCT01175382|FG001|Participant Flow|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
11024265|NCT01175382|FG002|Participant Flow|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
11024266|NCT01175382|OG000|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
11024267|NCT01175382|OG001|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
11024268|NCT01175382|OG002|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
11024269|NCT01175382|EG000|Reported Event|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
11024270|NCT01175382|EG001|Reported Event|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
10886663|NCT00495495|EG000|Reported Event|Ozone Treatment and Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randominzed to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
10886664|NCT00495521|BG000|Baseline|4-Aminosalicylic Acid Extended Release Granules|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
10886665|NCT00495521|BG001|Baseline|Placebo Granules|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
10886666|NCT00495521|BG002|Baseline|Total|Total of all reporting groups
10886667|NCT00495521|FG000|Participant Flow|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
10886668|NCT00495521|FG001|Participant Flow|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
10886669|NCT00495521|OG000|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
10886670|NCT00495521|OG001|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
10886671|NCT00495521|EG000|Reported Event|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
10886672|NCT00495521|EG001|Reported Event|Placebo|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
10886673|NCT00495586|BG000|Baseline|Placebo|Placebo pills t.i.d. for 8 days
10886674|NCT00495586|BG001|Baseline|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
10886675|NCT00495586|BG002|Baseline|Total|Total of all reporting groups
10886676|NCT00495586|FG000|Participant Flow|Placebo|Placebo pills t.i.d. for 8 days
10886677|NCT00495586|FG001|Participant Flow|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
10886678|NCT00495586|OG000|Outcome|Placebo|Placebo pills t.i.d. for 8 days
10886679|NCT00495586|OG001|Outcome|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
10886680|NCT00495586|OG000|Outcome|Amoxicillin and Clavulanic Acid|Eighty-three exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (83/143: 58%)
10886681|NCT00495586|OG001|Outcome|Placebo|Ninety exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (90/123: 73.2%)
10886682|NCT00495586|EG000|Reported Event|Placebo|Placebo pills t.i.d. for 8 days
10886683|NCT00495586|EG001|Reported Event|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
10886684|NCT00495612|BG000|Baseline|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
10886685|NCT00495612|BG001|Baseline|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
10886686|NCT00495612|BG002|Baseline|Total|Total of all reporting groups
10886687|NCT00495612|FG000|Participant Flow|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
10886688|NCT00495612|FG001|Participant Flow|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
10886689|NCT00495612|OG000|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
10886690|NCT00495612|OG001|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
10886691|NCT00495612|EG000|Reported Event|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
10886692|NCT00495612|EG001|Reported Event|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
10886693|NCT00495625|BG000|Baseline|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
10886694|NCT00495625|FG000|Participant Flow|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
10886695|NCT00495625|OG000|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
10886696|NCT00495625|EG000|Reported Event|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
10886697|NCT00495677|BG000|Baseline|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886698|NCT00495677|BG001|Baseline|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886699|NCT00495677|BG002|Baseline|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886700|NCT00495677|BG003|Baseline|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886701|NCT00495677|BG004|Baseline|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886702|NCT00495677|BG005|Baseline|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886703|NCT00495677|BG006|Baseline|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886704|NCT00495677|BG007|Baseline|Total|Total of all reporting groups
10886705|NCT00495677|FG000|Participant Flow|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886706|NCT00495677|FG001|Participant Flow|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886707|NCT00495677|FG002|Participant Flow|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886708|NCT00495677|FG003|Participant Flow|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886709|NCT00495677|FG004|Participant Flow|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886710|NCT00495677|FG005|Participant Flow|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886711|NCT00495677|FG006|Participant Flow|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886712|NCT00495677|OG000|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
11024271|NCT01175382|EG002|Reported Event|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
10886713|NCT00495677|OG001|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886714|NCT00495677|OG002|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886715|NCT00495677|OG003|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886716|NCT00495677|OG004|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886717|NCT00495677|OG005|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886718|NCT00495677|OG006|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886719|NCT00495677|EG000|Reported Event|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886720|NCT00495677|EG001|Reported Event|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886721|NCT00495677|EG002|Reported Event|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886722|NCT00495677|EG003|Reported Event|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886723|NCT00495677|EG004|Reported Event|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886724|NCT00495677|EG005|Reported Event|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
10886725|NCT00495677|EG006|Reported Event|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
10886726|NCT00495755|BG000|Baseline|Campath (Alemtuzumab)|
10886727|NCT00495755|FG000|Participant Flow|Campath (Alemtuzumab)|3 dose cohorts entered
10886728|NCT00495755|OG000|Outcome|Maximum Tolerated Dose (MTD)|
10886729|NCT00495755|OG000|Outcome|Response|
10886730|NCT00495755|EG000|Reported Event|Campath (Alemtuzumab)|
11024272|NCT01175395|BG000|Baseline|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
11024273|NCT01175395|FG000|Participant Flow|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
11024274|NCT01175395|OG000|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
11024275|NCT01175395|EG000|Reported Event|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
11024276|NCT01175434|BG000|Baseline|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
11024277|NCT01175434|BG001|Baseline|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
11024278|NCT01175434|BG002|Baseline|Total|Total of all reporting groups
11024279|NCT01175434|FG000|Participant Flow|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
11024280|NCT01175434|FG001|Participant Flow|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
11066298|NCT01391507|FG001|Participant Flow|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066299|NCT01391507|FG002|Participant Flow|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066300|NCT01391507|FG003|Participant Flow|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066301|NCT01391507|OG000|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066302|NCT01391507|OG001|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066303|NCT01391507|OG002|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066304|NCT01391507|OG003|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066305|NCT01391507|EG000|Reported Event|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066306|NCT01391507|EG001|Reported Event|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066307|NCT01391507|EG002|Reported Event|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066308|NCT01391507|EG003|Reported Event|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
11066309|NCT01391546|BG000|Baseline|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
11066310|NCT01391546|BG001|Baseline|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
11066311|NCT01391546|BG002|Baseline|Total|Total of all reporting groups
11066312|NCT01391546|FG000|Participant Flow|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
11024281|NCT01175434|OG000|Outcome|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
11024282|NCT01175434|OG001|Outcome|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
11024283|NCT01175434|EG000|Reported Event|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
11024284|NCT01175434|EG001|Reported Event|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
11024285|NCT01175473|BG000|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
11024286|NCT01175473|BG001|Baseline|Liraglutide|2-step initiation regimen of liraglutide: 0.6 mg QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
11024287|NCT01175473|BG002|Baseline|Total|Total of all reporting groups
11024288|NCT01175473|FG000|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
11024289|NCT01175473|FG001|Participant Flow|Liraglutide|2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
11024290|NCT01175473|OG000|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
11024291|NCT01175473|OG001|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
11024292|NCT01175473|EG000|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
11024293|NCT01175473|EG001|Reported Event|Liraglutide|2-step initiation regimen of liraglutide.
11024294|NCT01175590|BG000|Baseline|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
11024295|NCT01175590|BG001|Baseline|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
11024296|NCT01175590|BG002|Baseline|Total|Total of all reporting groups
11024297|NCT01175590|FG000|Participant Flow|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
11024298|NCT01175590|FG001|Participant Flow|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
11024299|NCT01175590|OG000|Outcome|Besivance|besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days
11024300|NCT01175590|OG001|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
11024301|NCT01175590|OG000|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
11024302|NCT01175590|EG000|Reported Event|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
11024303|NCT01175590|EG001|Reported Event|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
11024304|NCT01175668|BG000|Baseline|NMS/Clonidine|
11024305|NCT01175668|BG001|Baseline|NMS/Phenobarbital|
11024306|NCT01175668|BG002|Baseline|Total|Total of all reporting groups
11024307|NCT01175668|FG000|Participant Flow|NMS/Clonidine|"Dosing was based on the Finnegan scores as below~Finn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day* + Clonidine 12 mcg/kg/day~Daily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia~*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
11024308|NCT01175668|FG001|Participant Flow|NMS/Phenobarbital|"Dosing was based on the Finnegan scores as below~Finn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day* + Phenobarbital 12 mg/kg/day~Daily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval~*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
11024309|NCT01175668|OG000|Outcome|NMS/Clonidine|
11024310|NCT01175668|OG001|Outcome|NMS/Phenobarbital|
11024311|NCT01175668|EG000|Reported Event|NMS/Clonidine|
11024312|NCT01175668|EG001|Reported Event|NMS/Phenobarbital|
11024313|NCT01175707|BG000|Baseline|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
11024314|NCT01175707|BG001|Baseline|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
11024315|NCT01175707|BG002|Baseline|Total|Total of all reporting groups
11024316|NCT01175707|FG000|Participant Flow|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
11024317|NCT01175707|FG001|Participant Flow|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
11024318|NCT01175707|OG000|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
11024319|NCT01175707|OG001|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
11024320|NCT01175707|OG000|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
11024321|NCT01175707|EG000|Reported Event|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
11024322|NCT01175707|EG001|Reported Event|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
11024323|NCT01175798|BG000|Baseline|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
11024324|NCT01175798|BG001|Baseline|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
11024325|NCT01175798|BG002|Baseline|Total|Total of all reporting groups
11024326|NCT01175798|FG000|Participant Flow|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
11024327|NCT01175798|FG001|Participant Flow|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
11024328|NCT01175798|OG000|Outcome|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
11024329|NCT01175798|OG001|Outcome|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
11024330|NCT01175798|EG000|Reported Event|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
11148729|NCT01866826|EG001|Reported Event|Placebo|"HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.~Placebo: Subject will receive three capsules of placebo by mouth twice daily."
11024331|NCT01175798|EG001|Reported Event|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
11024332|NCT01175811|BG000|Baseline|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
11024333|NCT01175811|BG001|Baseline|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
11024334|NCT01175811|BG002|Baseline|Total|Total of all reporting groups
11024335|NCT01175811|FG000|Participant Flow|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
11024336|NCT01175811|FG001|Participant Flow|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro~Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
11024337|NCT01175811|OG000|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
11024338|NCT01175811|OG001|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
11024339|NCT01175811|EG000|Reported Event|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
11024340|NCT01175811|EG001|Reported Event|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro~Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
11024341|NCT01175824|BG000|Baseline|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
11024342|NCT01175824|BG001|Baseline|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
11024343|NCT01175824|BG002|Baseline|Total|Total of all reporting groups
11148730|NCT01866839|BG000|Baseline|CD34+ Cell Positively Selected Graft Stem Cell Recipient|Recipients received a myeloablative conditioning regimen of cyclophosphamide (120 mg/kg total), fludarabine (125 mg/m2 total) and total body irradiation (1200 cGy with lung shielding to 600 cGy), followed by an infusion of a stem cell product selected for CD34+ progenitors using the Miltenyi CliniMACS® system. Older subjects will receive a lower dose of irradiation (800 or 600 cGy based on age) to reduce the regimen intensity.
11024344|NCT01175824|FG000|Participant Flow|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
11024345|NCT01175824|FG001|Participant Flow|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
11024346|NCT01175824|OG000|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
11024347|NCT01175824|OG001|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
11024348|NCT01175824|EG000|Reported Event|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
11024349|NCT01175824|EG001|Reported Event|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
11024350|NCT01175850|BG000|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
11024351|NCT01175850|BG001|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
11024352|NCT01175850|BG002|Baseline|Total|Total of all reporting groups
11024353|NCT01175850|FG000|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11024354|NCT01175850|FG001|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11024355|NCT01175850|OG000|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
11024356|NCT01175850|OG001|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
11024357|NCT01175850|OG001|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11024358|NCT01175850|EG000|Reported Event|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~Drug-Coated Balloon (DCB): balloon dilatation and provisional stenting with IN.PACT DCB"
11024359|NCT01175850|EG001|Reported Event|Standard PTA|"Standard Percutaneous Transluminal Angioplasty (PTA) Balloon: Balloon Angioplasty~PTA Balloon: Balloon Angioplasty: balloon dilatation and provisional stenting with standard non-coated PTA balloon"
11024360|NCT01175902|BG000|Baseline|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024361|NCT01175902|BG001|Baseline|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024362|NCT01175902|BG002|Baseline|Total|Total of all reporting groups
11024363|NCT01175902|FG000|Participant Flow|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024364|NCT01175902|FG001|Participant Flow|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024365|NCT01175902|OG000|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024366|NCT01175902|OG001|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024367|NCT01175902|OG000|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024368|NCT01175902|OG001|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024369|NCT01175902|EG000|Reported Event|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024370|NCT01175902|EG001|Reported Event|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
11024371|NCT01175980|BG000|Baseline|Treatment (Vorinostat)|"Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11024372|NCT01175980|FG000|Participant Flow|Treatment (Vorinostat)|"Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11024373|NCT01175980|OG000|Outcome|Treatment (Vorinostat)|"Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11024374|NCT01175980|EG000|Reported Event|Treatment (Vorinostat)|"Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11024375|NCT01176032|BG000|Baseline|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
11024376|NCT01176032|BG001|Baseline|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
11024377|NCT01176032|BG002|Baseline|Total|Total of all reporting groups
11024378|NCT01176032|FG000|Participant Flow|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
11024379|NCT01176032|FG001|Participant Flow|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
11024380|NCT01176032|OG000|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
11024381|NCT01176032|OG001|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
11024382|NCT01176032|OG001|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
11024383|NCT01176032|OG002|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
10886731|NCT00495794|BG000|Baseline|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
11024384|NCT01176032|OG003|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
11024385|NCT01176032|OG001|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
11024386|NCT01176032|OG002|Outcome|Losartan|losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
11024387|NCT01176032|EG000|Reported Event|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
11024388|NCT01176032|EG001|Reported Event|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
11024389|NCT01176058|BG000|Baseline|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
11024390|NCT01176058|BG001|Baseline|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
11024391|NCT01176058|BG002|Baseline|Total|Total of all reporting groups
11024392|NCT01176058|FG000|Participant Flow|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
11024393|NCT01176058|FG001|Participant Flow|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
11024394|NCT01176058|OG000|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
11024395|NCT01176058|OG001|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
11024396|NCT01176058|EG000|Reported Event|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
11024397|NCT01176058|EG001|Reported Event|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
11066313|NCT01391546|FG001|Participant Flow|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
11066314|NCT01391546|OG000|Outcome|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
11066315|NCT01391546|OG001|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
11066316|NCT01391546|OG000|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
11066317|NCT01391546|EG000|Reported Event|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
11066318|NCT01391546|EG001|Reported Event|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
11066319|NCT01391559|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Arformoterol first and Salmeterol first
11066320|NCT01391559|FG000|Participant Flow|Arformoterol First, Then Salmeterol|Arformoterol (15 mcg/2 mL) solution via nebulizer in the first intervention, Salmeterol (50 mcg) Diskus in the second intervention
11024398|NCT01176240|BG000|Baseline|Study 306A: Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
11024399|NCT01176240|BG001|Baseline|Study 306A: Placebo|"Placebo matched control~Placebo: Placebo"
11024400|NCT01176240|BG002|Baseline|Study 306B: Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
11225786|NCT02370394|FG000|Participant Flow|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
11225787|NCT02370394|FG001|Participant Flow|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
11225788|NCT02370394|OG000|Outcome|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
11225789|NCT02370394|OG001|Outcome|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
11225790|NCT02370394|OG001|Outcome|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later..
11225791|NCT02370394|EG000|Reported Event|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
11225792|NCT02370394|EG001|Reported Event|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
11225793|NCT02370407|BG000|Baseline|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).~a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
11225794|NCT02370407|BG001|Baseline|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).~Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
11225795|NCT02370407|BG002|Baseline|Total|Total of all reporting groups
11024401|NCT01176240|BG003|Baseline|Study 306B: Placebo|"Placebo matched control~Placebo: Placebo"
11024402|NCT01176240|BG004|Baseline|Total|Total of all reporting groups
11024403|NCT01176240|FG000|Participant Flow|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
11024404|NCT01176240|FG001|Participant Flow|Placebo|"Placebo matched control~Placebo: Placebo"
11024405|NCT01176240|OG000|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
11024406|NCT01176240|OG001|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
11024407|NCT01176240|EG000|Reported Event|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment~Droxidopa Safety set includes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
11024408|NCT01176240|EG001|Reported Event|Placebo|"Placebo matched control~Placebo: Placebo~Placebo Safety set excludes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
11024409|NCT01176266|BG000|Baseline|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
11024410|NCT01176266|FG000|Participant Flow|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
11024411|NCT01176266|OG000|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
11024412|NCT01176266|OG000|Outcome|Baseline|Baseline assessment before initiation of asfotase alfa
11024413|NCT01176266|OG001|Outcome|Asfotase Alfa - Without Respiratory Support at Baseline|Results at End of Study for Those Without Respiratory Support at Baseline (Last Assessment for Each Patient)
11024414|NCT01176266|OG002|Outcome|Asfotase Alfa - With Respiratory Support at Baseline|Results at End of Study for Those With Respiratory Support at Baseline (Last Assessment for Each Patient)
11024415|NCT01176266|OG000|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (2 mg/kg asfotase alfa 3 times per week)
11024416|NCT01176266|EG000|Reported Event|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
11024417|NCT01176292|BG000|Baseline|Rotating Platform High-Flex Cruciate Substituting TKA|
11024418|NCT01176292|BG001|Baseline|Rotating Platform Cruciate Substituting TKA|
11024419|NCT01176292|BG002|Baseline|Total|Total of all reporting groups
11024420|NCT01176292|FG000|Participant Flow|Rotating Platform High-Flex Cruciate Substituting TKA|
11024421|NCT01176292|FG001|Participant Flow|Rotating Platform Cruciate Substituting TKA|
11024422|NCT01176292|OG000|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
11024423|NCT01176292|OG001|Outcome|Rotating Platform Cruciate Substituting TKA|
11024424|NCT01176292|EG000|Reported Event|Rotating Platform High-Flex Cruciate Substituting TKA|
11024425|NCT01176292|EG001|Reported Event|Rotating Platform Cruciate Substituting TKA|
11024426|NCT01176435|BG000|Baseline|0.76 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024427|NCT01176435|BG001|Baseline|0.51 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024428|NCT01176435|BG002|Baseline|Placebo|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024429|NCT01176435|BG003|Baseline|Total|Total of all reporting groups
11024430|NCT01176435|FG000|Participant Flow|0.76 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024431|NCT01176435|FG001|Participant Flow|0.51 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024432|NCT01176435|FG002|Participant Flow|Placebo|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024433|NCT01176435|OG000|Outcome|0.76 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024434|NCT01176435|OG001|Outcome|0.51 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024435|NCT01176435|OG002|Outcome|Placebo|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024436|NCT01176435|EG000|Reported Event|0.76 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024437|NCT01176435|EG001|Reported Event|0.51 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024438|NCT01176435|EG002|Reported Event|Placebo|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
11024439|NCT01176448|BG000|Baseline|Patients With Scars|12 individual scars on 6 patients were treated. Each scar was divided in half, and the halves randomized to either fractionated laser resurfacing or dermabrasion.
11024440|NCT01176448|FG000|Participant Flow|Patients With Scars|"12 long scars were recruited for individual study. Only 6 patients were needed as each patient had two separate scars to be studied. Each scar was divided in half, and the halves randomized to fractionated laser resurfacing or dermabrasion.~The half of the scar randomized to fractionated CO2 laser was treated first. The Re:Pair CO2 laser was used, with a fluence of 40 mJ and a treatment level of 8 (Solta Medical Inc., Hayward, CA). Four passes of the laser were used in total, with two in the orthogonal direction. A standard diamond fraise dermabrader was used on the area painted with gentian violet down through the dermal-epidermal junction. Dermabrasion was performed until a uniform area of punctate bleeding was obtained, and the edges were feathered into the surrounding epidermis."
11024441|NCT01176448|OG000|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
11024442|NCT01176448|OG001|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
11024443|NCT01176448|OG000|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser. 6 patients had 12 scars treated (2 scars per patient.
11024444|NCT01176448|OG001|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared. 6 patients had 12 scars treated (2 scars per patient.
11024445|NCT01176448|EG000|Reported Event|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
11024446|NCT01176448|EG001|Reported Event|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
11066321|NCT01391559|FG001|Participant Flow|Salmeterol First, Then Arformoterol|Salmeterol (50 mcg) Diskus in the first intervention, Arformoterol (15 mcg/2 mL) solution via nebulizer in the second intervention
11066322|NCT01391559|OG000|Outcome|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
11066323|NCT01391559|OG001|Outcome|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
11024447|NCT01176565|BG000|Baseline|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
11024448|NCT01176565|BG001|Baseline|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
11024449|NCT01176565|BG002|Baseline|Total|Total of all reporting groups
11024450|NCT01176565|FG000|Participant Flow|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater then the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
11024451|NCT01176565|FG001|Participant Flow|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
11024452|NCT01176565|OG000|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
11024453|NCT01176565|OG001|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
11024454|NCT01176565|EG000|Reported Event|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
11066324|NCT01391559|EG000|Reported Event|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
11066325|NCT01391559|EG001|Reported Event|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
11066326|NCT01391611|BG000|Baseline|Pazopanib Arm|Pazopanib: 800 mg; PO
11024455|NCT01176565|EG001|Reported Event|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
11024456|NCT01176591|BG000|Baseline|Placebo Session 1, Aprepitant Session 2|Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.
11024457|NCT01176591|BG001|Baseline|Placebo Session1, Placebo Session 2|Placebo, one per session, oral administration
11024458|NCT01176591|BG002|Baseline|Total|Total of all reporting groups
11024459|NCT01176591|FG000|Participant Flow|Placebo Session 1, Aprepitant Session 2|Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.
11024460|NCT01176591|FG001|Participant Flow|Placebo in Session 1, Placebo in Session 2|Placebo, one per session, oral administration
11024461|NCT01176591|OG000|Outcome|Placebo Session 1, Aprepitant Session 2|Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.
11024462|NCT01176591|OG001|Outcome|Placebo Session 1, Placebo Session 2|Placebo in Session 1, Placebo in Session 2, oral administration
11024463|NCT01176591|OG000|Outcome|Placebo Session 1, Aprepitant Session 2|Placebo session 1, Aprepitant 80 mg session 2, oral administration.
11024464|NCT01176591|OG001|Outcome|Placebo Session 1, Placebo Session 2|Placebo, one per session, oral administration
11024465|NCT01176591|EG000|Reported Event|Placebo Session1, Aprepitant Session 2|Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration
11024466|NCT01176591|EG001|Reported Event|Placebo Session1, Placebo Session 2|Placebo, one per session, oral administration
11225796|NCT02370407|FG000|Participant Flow|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).~a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
11024467|NCT01176617|BG000|Baseline|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
11024468|NCT01176617|BG001|Baseline|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure."
11024469|NCT01176617|BG002|Baseline|Total|Total of all reporting groups
11024470|NCT01176617|FG000|Participant Flow|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
11024471|NCT01176617|FG001|Participant Flow|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure."
11024472|NCT01176617|FG002|Participant Flow|CM and Reveal XT|This was the non-randomized phase of the study in the first six months of evaluation.
11024473|NCT01176617|OG000|Outcome|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
11024474|NCT01176617|OG001|Outcome|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure."
11024475|NCT01176617|OG002|Outcome|Reveal XT and Conventional Monitoring|This was the non-randomized phase of the study in the first six months of evaluation.
11024476|NCT01176617|OG001|Outcome|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.~For details, please refer to the following citation of the published study: Kapa, et al, Journal of Cardiovascular Electrophysiology 2013; DOI:10.1111/JCE. 12141"
11024477|NCT01176617|EG000|Reported Event|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
11024478|NCT01176617|EG001|Reported Event|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure."
11024479|NCT01176773|BG000|Baseline|Juvéderm® Ultra Lip Injectable Gel|
11024480|NCT01176773|FG000|Participant Flow|Juvéderm® Ultra Lip Injectable Gel|
11024481|NCT01176773|OG000|Outcome|Juvéderm® Ultra Lip Injectable Gel|The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
11024482|NCT01176773|OG000|Outcome|Juvéderm® Ultra Lip Injectable Gel|
11024483|NCT01176773|EG000|Reported Event|Juvéderm® Ultra Lip Injectable Gel|
11024484|NCT01176877|BG000|Baseline|Keloid Scar|Those with a diagnosis of keloid scar.
11024485|NCT01176877|FG000|Participant Flow|Keloid Scar|Subjects over the age of 18 with a clinical diagnosis of keloid scarring were included in the study. First, subjects completed a written questionnaire to collect demographic data, including personal history of keloid scarring, past and present use of keloid scar treatments, and internet access and use to find information related to keloid scars. Second, subjects completed a written questionnaire to assess knowledge about keloids. Next, subjects listened to a scripted, 5 minute educational lecture about keloid scars and then completed a written questionnaire to assess knowledge about keloids. Finally, subjects were contacted by phone 3 months later to complete a questionnaire to assess knowledge about keloids and to answer questions about keloid-related behaviors over the previous 3 months.
11024486|NCT01176877|OG000|Outcome|Keloid Scar|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. Immediately after the educational lecture, the subjects completed an identical written questionnaire to assess knowledge about keloid scars.
11024487|NCT01176877|OG000|Outcome|Keloid Scars|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. 3 months after the educational lecture, subjects completed an identical verbal questionnaire to assess knowledge about keloid scars.
11024488|NCT01176877|EG000|Reported Event|Keloid Scar|
11024489|NCT01176916|BG000|Baseline|Exemestane|Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
11024490|NCT01176916|FG000|Participant Flow|Exemestane|Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
11024491|NCT01176916|OG000|Outcome|Exemestane|Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
11024492|NCT01176916|EG000|Reported Event|Exemestane|Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
11024493|NCT01176955|BG000|Baseline|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
11024494|NCT01176955|BG001|Baseline|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
11024495|NCT01176955|BG002|Baseline|Total|Total of all reporting groups
11024496|NCT01176955|FG000|Participant Flow|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
11024497|NCT01176955|FG001|Participant Flow|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
11024498|NCT01176955|OG000|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
11024499|NCT01176955|OG001|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
11024500|NCT01176955|OG000|Outcome|Internet Survey|Patients received a weekly Internet survey to report on the status of their acne.
11024501|NCT01176955|OG001|Outcome|Control|Patients received standard-of-care therapy without weekly Internet surveys.
11024502|NCT01176955|OG000|Outcome|All Participants|This group includes all participants in the study.
11024503|NCT01176955|EG000|Reported Event|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
11024504|NCT01176955|EG001|Reported Event|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
11024505|NCT01176968|BG000|Baseline|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
11024506|NCT01176968|BG001|Baseline|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
11024507|NCT01176968|BG002|Baseline|Total|Total of all reporting groups
11024508|NCT01176968|FG000|Participant Flow|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
11024509|NCT01176968|FG001|Participant Flow|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
11024510|NCT01176968|OG000|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
11024511|NCT01176968|OG001|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
11024512|NCT01176968|EG000|Reported Event|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
11024513|NCT01176968|EG001|Reported Event|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
11024514|NCT01176981|BG000|Baseline|HDMTX|"This is a single arm study. All subjects enrolled in the study will be in this arm.~High Dose Methotrexate: Methotrexate will be given by IV at a dose of 12 gram/m2/dose.~The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days)."
11024515|NCT01176981|FG000|Participant Flow|HDMTX|"This is a single arm study. All subjects enrolled in the study will be in this arm.~High Dose Methotrexate: Methotrexate will be given by IV at a dose of 12 gram/m2/dose.~The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days)."
11024516|NCT01176981|OG000|Outcome|HD MTX|all patients received outpatient HD MTX
11024517|NCT01176981|EG000|Reported Event|HDMTX|"This is a single arm study. All subjects enrolled in the study will be in this arm.~High Dose Methotrexate: Methotrexate will be given by IV at a dose of 12 gram/m2/dose.~The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days)."
11024518|NCT01177007|BG000|Baseline|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
11024519|NCT01177007|FG000|Participant Flow|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
11024520|NCT01177007|OG000|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
11024521|NCT01177007|OG000|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
11024522|NCT01177007|OG000|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each treated lob
11024523|NCT01177007|EG000|Reported Event|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
11066327|NCT01391611|FG000|Participant Flow|Pazopanib Arm|Pazopanib: 800 mg; PO
11148731|NCT01866839|FG000|Participant Flow|CD34+ Cell Positively Selected Graft Stem Cell Recipient|Recipients received a myeloablative conditioning regimen of cyclophosphamide (120 mg/kg total), fludarabine (125 mg/m2 total) and total body irradiation (1200 cGy with lung shielding to 600 cGy), followed by an infusion of a stem cell product selected for CD34+ progenitors using the Miltenyi CliniMACS® system. Older subjects will receive a lower dose of irradiation (800 or 600 cGy based on age) to reduce the regimen intensity.
11148732|NCT01866839|OG000|Outcome|CD34+ Cell Positively Selected Graft Stem Cell Recipient|Recipients received a myeloablative conditioning regimen of cyclophosphamide (120 mg/kg total), fludarabine (125 mg/m2 total) and total body irradiation (1200 cGy with lung shielding to 600 cGy), followed by an infusion of a stem cell product selected for CD34+ progenitors using the Miltenyi CliniMACS® system. Older subjects will receive a lower dose of irradiation (800 or 600 cGy based on age) to reduce the regimen intensity.
11148733|NCT01866839|EG000|Reported Event|CD34+ Cell Positively Selected Graft Stem Cell Recipient|Recipients received a myeloablative conditioning regimen of cyclophosphamide (120 mg/kg total), fludarabine (125 mg/m2 total) and total body irradiation (1200 cGy with lung shielding to 600 cGy), followed by an infusion of a stem cell product selected for CD34+ progenitors using the Miltenyi CliniMACS® system. Older subjects will receive a lower dose of irradiation (800 or 600 cGy based on age) to reduce the regimen intensity.
11148734|NCT01866917|BG000|Baseline|Transversus Abdominal Plane (Drug B)|Ropivicaine 0.5% 20cc injectate bilaterally
11148735|NCT01866917|BG001|Baseline|Saline (Drug A)|Normal saline 20cc injectate bilaterally
11148736|NCT01866917|BG002|Baseline|Total|Total of all reporting groups
11148737|NCT01866917|FG000|Participant Flow|Transversus Abdominal Plane|"Ropivicaine 0.5% 20cc injectate bilaterally~Group B"
11148738|NCT01866917|FG001|Participant Flow|Saline|"Normal saline 20cc injectate bilaterally~Group A"
11148739|NCT01866917|OG000|Outcome|Transversus Abdominis Plane (TAP) Group B|Ropivicaine 0.5% 20cc IV bilaterally
11148740|NCT01866917|OG001|Outcome|Saline Group A|Normal saline 20cc IV bilaterally
11148741|NCT01866917|OG000|Outcome|Transversus Abdominis Plane (TAP) Group B|"Ropivicaine 0.5% 20cc injectate bilaterally~Ropivacaine 0.5% 20cc injectate bilaterally"
11148742|NCT01866917|OG001|Outcome|Saline Group A|Normal saline 20cc injectate bilaterally
11148743|NCT01866917|EG000|Reported Event|Group B (TAP Block)|The anesthesiologist performing the TAP block will administer an injectate of either normal saline or the TAP block in a study labeled syringe that will be drawn by an OR staff member not involved in the surgery or analysis of study data. The protocol is as follows-- prior to skin incision, under ultrasound guidance, the abdominal wall muscular layers will be identified. A linear 6-13 MHz ultrasound transducer will be used. Once the plane is clearly identified between the internal oblique and transversus abdominal muscles, a 20cc injectate of saline or Ropivacaine 0.5% will be administered bilaterally under direct visualization at the site target using a 2 or 4 inch stimiplex needle depending on the size of the patient.
11148744|NCT01866917|EG001|Reported Event|Group A (Saline)|The anesthesiologist performing the TAP block will administer an injectate of either normal saline or the TAP block in a study labeled syringe that will be drawn by an OR staff member not involved in the surgery or analysis of study data. The protocol is as follows-- prior to skin incision, under ultrasound guidance, the abdominal wall muscular layers will be identified. A linear 6-13 MHz ultrasound transducer will be used. Once the plane is clearly identified between the internal oblique and transversus abdominal muscles, a 20cc injectate of saline or Ropivacaine 0.5% will be administered bilaterally under direct visualization at the site target using a 2 or 4 inch stimiplex needle depending on the size of the patient.
11148745|NCT01866943|BG000|Baseline|All Study Participants|"Baseline population, Groups are as follows:~Group 1 (Normal Saline Solution) Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Group 2 (Tranexamic Acid) Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.~Since only blinded and deidentified data is available, Baseline measures will be reported on the entire population."
11148746|NCT01866943|FG000|Participant Flow|Group 1|"Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Normal Saline Solution"
11148747|NCT01866943|FG001|Participant Flow|Group 2|"Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug."
11148748|NCT01866943|OG000|Outcome|Baseline Population|Data for 12 subjects is available, and cannot determine between groups as only data available is de-identified and blinded. Reporting data for these 12 subjects.
11148749|NCT01866943|OG000|Outcome|Baseline Population|Data for this outcome measure is available for 16 subjects, and cannot determine between groups as only data available is de-identified and blinded. Therefore data for these 16 subjects is reported.
11148750|NCT01866943|OG000|Outcome|All Study Participants|Data for this outcome is available for 4 subjects, and group membership is unknown as all data available is de-identified and blinded. Therefore data in these 4 subjects is reported.
11148751|NCT01866943|OG000|Outcome|All Study Participants|Data for this outcome is available for 35 subjects, and group membership is unknown as all data available is de-identified and blinded. Therefore data in these 35 subjects is reported.
11148752|NCT01866943|OG000|Outcome|All Study Participants|Data for this outcome is available for 31 subjects, and group membership is unknown as all data available is de-identified and blinded. Therefore data in these 31 subjects is reported.
11148753|NCT01866943|EG000|Reported Event|Group 1|"Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Normal Saline Solution"
11148754|NCT01866943|EG001|Reported Event|Group 2|"Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug."
11148755|NCT01867008|BG000|Baseline|Nucleus CI422 Cochlear Implant With N6 Sound Processor|Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
11148756|NCT01867008|FG000|Participant Flow|Nucleus CI422 Cochlear Implant With N6 Sound Processor|Newly implanted patient population seeking cochlear implantation as standard of care
11148757|NCT01867008|OG000|Outcome|Nucleus CI422 Cochlear Implant With N6 Sound Processor|Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
11148758|NCT01867008|EG000|Reported Event|Nucleus CI422 Cochlear Implant With N6 Sound Processor|Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
11148759|NCT01867021|BG000|Baseline|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
11148760|NCT01867021|BG001|Baseline|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
11148761|NCT01867021|BG002|Baseline|Total|Total of all reporting groups
11148762|NCT01867021|FG000|Participant Flow|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
11148763|NCT01867021|FG001|Participant Flow|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
11148764|NCT01867021|OG000|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
11148765|NCT01867021|OG001|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
11148766|NCT01867021|OG000|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
11148767|NCT01867021|OG001|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
11148768|NCT01867021|OG002|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
11148769|NCT01867021|OG003|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
11148770|NCT01867021|EG000|Reported Event|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
11148771|NCT01867021|EG001|Reported Event|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
11148772|NCT01867021|EG002|Reported Event|Total|Total number of Subjects
11148773|NCT01867047|BG000|Baseline|Continuation Group|ACE-I Continuation group: Subjects take ACE-I through day of surgery
11148774|NCT01867047|BG001|Baseline|Cessation Group|ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
11148775|NCT01867047|BG002|Baseline|Total|Total of all reporting groups
11148776|NCT01867047|FG000|Participant Flow|Continuation Group|ACE-I Continuation group: Subjects take ACE-I through day of surgery
11148777|NCT01867047|FG001|Participant Flow|Cessation Group|ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
11148778|NCT01867047|OG000|Outcome|Continuation Group|ACE-I Continuation group: Subjects take ACE-I through day of surgery
11148779|NCT01867047|OG001|Outcome|Cessation Group|ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
11148780|NCT01867047|OG000|Outcome|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery"
11148781|NCT01867047|OG001|Outcome|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery"
11148782|NCT01867047|OG000|Outcome|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery. Examples of possible ACE-I drugs include:~benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)"
11148783|NCT01867047|OG001|Outcome|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery. Examples of possible ACE-I drugs include:~benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)"
11148784|NCT01867047|EG000|Reported Event|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery"
11148785|NCT01867047|EG001|Reported Event|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery"
11148786|NCT01867086|BG000|Baseline|Vigil™ Vaccine|Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
11150213|NCT01876381|BG000|Baseline|OPC-41061|Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
11024524|NCT01177059|BG000|Baseline|Anti-HIV-1 Ribozyme (OZ1) Transduced Cells|Participants who received an infusion of final cell product (that is, a cluster of differentiation [CD]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
11024525|NCT01177059|FG000|Participant Flow|Anti-HIV-1 Ribozyme (OZ1) Transduced Cells|Participants who received an infusion of final cell product (that is, a cluster of differentiation [CD]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
11024526|NCT01177059|OG000|Outcome|Anti-HIV-1 Ribozyme (OZ1) Transduced Cells|Participants who received an infusion of final cell product (that is, a cluster of differentiation [CD]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
11024527|NCT01177059|EG000|Reported Event|Anti-HIV-1 Ribozyme (OZ1) Transduced Cells|Participants who received an infusion of final cell product (that is, a cluster of differentiation [CD]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
11024528|NCT01177098|BG000|Baseline|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
11024529|NCT01177098|BG001|Baseline|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
11024530|NCT01177098|BG002|Baseline|Total|Total of all reporting groups
11024531|NCT01177098|FG000|Participant Flow|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
11024532|NCT01177098|FG001|Participant Flow|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
11024533|NCT01177098|OG000|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
11024534|NCT01177098|OG001|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
11024535|NCT01177098|EG000|Reported Event|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
11024536|NCT01177098|EG001|Reported Event|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
11225797|NCT02370407|FG001|Participant Flow|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).~Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
11024537|NCT01177137|BG000|Baseline|Tinnitus Retraining Therapy (TRT)|"TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC).~The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus)~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11024538|NCT01177137|BG001|Baseline|Partial Tinnitus Retraining Therapy (Partial TRT)|"Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).~The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices.~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11024539|NCT01177137|BG002|Baseline|Standard of Care (SC)|"The standard of care arm includes care as typically delivered in US military medical centers~The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options."
11024540|NCT01177137|BG003|Baseline|Total|Total of all reporting groups
11066328|NCT01391611|OG000|Outcome|Pazopanib Arm|Pazopanib: 800 mg; PO
11066329|NCT01391611|EG000|Reported Event|Pazopanib Arm|Pazopanib: 800 mg; PO
11066330|NCT01391663|BG000|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
11066331|NCT01391663|BG001|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
11066332|NCT01391663|BG002|Baseline|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
11066333|NCT01391663|BG003|Baseline|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
11066334|NCT01391663|BG004|Baseline|Total|Total of all reporting groups
11024541|NCT01177137|FG000|Participant Flow|Tinnitus Retraining Therapy (TRT)|"TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC).~The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus)~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11024542|NCT01177137|FG001|Participant Flow|Partial Tinnitus Retraining Therapy (Partial TRT)|"Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).~The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices.~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11024543|NCT01177137|FG002|Participant Flow|Standard of Care (SC)|"The standard of care arm includes care as typically delivered in US military medical centers~The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options."
11024544|NCT01177137|OG000|Outcome|Tinnitus Retraining Therapy (TRT)|"TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC).~The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus)~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11024545|NCT01177137|OG001|Outcome|Partial Tinnitus Retraining Therapy (Partial TRT)|"Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).~The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices.~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11024546|NCT01177137|OG002|Outcome|Standard of Care (SC)|"The standard of care arm includes care as typically delivered in US military medical centers~The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options."
11024547|NCT01177137|OG000|Outcome|Tinnitus Retraining Therapy|"TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC).~The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus)~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11066335|NCT01391663|FG000|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
11066336|NCT01391663|FG001|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
11066337|NCT01391663|FG002|Participant Flow|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
11066338|NCT01391663|FG003|Participant Flow|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
11066339|NCT01391663|OG000|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
11024548|NCT01177137|OG001|Outcome|Partial Tinnitus Retraining Therapy|"Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).~Placebo sound generator (placebo SG): Tranquil model placebo sound generators (General Hearing Instruments, Inc.) are either inside or outside-the-ear devices that generate a sound different from the active devices.~Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process."
11024549|NCT01177137|OG002|Outcome|Standard of Care (SC)|"The standard of care arm includes care as typically delivered in US military medical centers~Standard of Care (SC): The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options."
11024550|NCT01177137|EG000|Reported Event|Tinnitus Retraining Therapy (TRT)|"TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC).~The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus)~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11024551|NCT01177137|EG001|Reported Event|Partial Tinnitus Retraining Therapy (Partial TRT)|"Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).~The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices.~Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process."
11024552|NCT01177137|EG002|Reported Event|Standard of Care (SC)|"The standard of care arm includes care as typically delivered in US military medical centers~The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options."
11024553|NCT01177189|BG000|Baseline|Arm 1|"Young healthy men and women aged 18-30~Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily"
11024554|NCT01177189|BG001|Baseline|Arm 2|"Older healthy men and women aged >70.~Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily"
11024555|NCT01177189|BG002|Baseline|Total|Total of all reporting groups
11024556|NCT01177189|FG000|Participant Flow|Arm 1|"Young healthy men and women aged 18-30~Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily"
11024557|NCT01177189|FG001|Participant Flow|Arm 2|"Older healthy men and women aged >70.~Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily"
11024558|NCT01177189|OG000|Outcome|Arm 1|"Young healthy men and women aged 18-30~Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily"
11024559|NCT01177189|OG001|Outcome|Arm 2|"Older healthy men and women aged >70.~Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily"
11024560|NCT01177189|EG000|Reported Event|Arm 1|"Young healthy men and women aged 18-30~Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily"
11024561|NCT01177189|EG001|Reported Event|Arm 2|"Older healthy men and women aged >70.~Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily"
11024562|NCT01177228|BG000|Baseline|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
11024563|NCT01177228|BG001|Baseline|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024564|NCT01177228|BG002|Baseline|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85.
11024565|NCT01177228|BG003|Baseline|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024566|NCT01177228|BG004|Baseline|Total|Total of all reporting groups
11024567|NCT01177228|FG000|Participant Flow|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
11024568|NCT01177228|FG001|Participant Flow|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.
11024569|NCT01177228|FG002|Participant Flow|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024570|NCT01177228|FG003|Participant Flow|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.
11024571|NCT01177228|OG000|Outcome|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
11024572|NCT01177228|OG001|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024573|NCT01177228|OG002|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024574|NCT01177228|OG003|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024575|NCT01177228|OG000|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024576|NCT01177228|OG001|Outcome|Vedolizumab (6 mg/kg)|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024577|NCT01177228|OG002|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024578|NCT01177228|OG001|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024579|NCT01177228|OG000|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
11024580|NCT01177228|EG000|Reported Event|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
11024581|NCT01177228|EG001|Reported Event|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024582|NCT01177228|EG002|Reported Event|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024583|NCT01177228|EG003|Reported Event|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
11024584|NCT01177293|BG000|Baseline|Entire Study Population|Includes groups randomized to receive any treatment first (amlodipine capsule first and amlodipine ODT first).
11024585|NCT01177293|FG000|Participant Flow|Amlodipine Capsule Then Amlodipine ODT|Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period.
11024586|NCT01177293|FG001|Participant Flow|Amlodipine ODT Then Amlodipine Capsule|Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.
11225798|NCT02370407|OG000|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
11225799|NCT02370407|OG001|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
11225800|NCT02370407|OG000|Outcome|Laparoscopic|10 repetitions on laparoscopic task
11024587|NCT01177293|OG000|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
11024588|NCT01177293|OG001|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
11024589|NCT01177293|EG000|Reported Event|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
11024590|NCT01177293|EG001|Reported Event|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
11024591|NCT01177384|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
11024592|NCT01177384|BG001|Baseline|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
11024593|NCT01177384|BG002|Baseline|Total|Total of all reporting groups
11024594|NCT01177384|FG000|Participant Flow|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
11024595|NCT01177384|FG001|Participant Flow|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
11024596|NCT01177384|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
11024597|NCT01177384|OG001|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
11024598|NCT01177384|EG000|Reported Event|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
11024599|NCT01177384|EG001|Reported Event|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
11024600|NCT01177410|BG000|Baseline|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
11024601|NCT01177410|BG001|Baseline|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
11024602|NCT01177410|BG002|Baseline|Placebo|Placebo : placebo capsules once daily for 12 weeks
11024603|NCT01177410|BG003|Baseline|Total|Total of all reporting groups
11024604|NCT01177410|FG000|Participant Flow|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
11024605|NCT01177410|FG001|Participant Flow|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
11024606|NCT01177410|FG002|Participant Flow|Placebo|Placebo : placebo capsules once daily for 12 weeks
11024607|NCT01177410|OG000|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
11024608|NCT01177410|OG001|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
11024609|NCT01177410|OG002|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
11024610|NCT01177410|EG000|Reported Event|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
11024611|NCT01177410|EG001|Reported Event|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
11024612|NCT01177410|EG002|Reported Event|Placebo|Placebo : placebo capsules once daily for 12 weeks
11024613|NCT01177553|BG000|Baseline|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
11066340|NCT01391663|OG001|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
11024614|NCT01177553|BG001|Baseline|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
11024615|NCT01177553|BG002|Baseline|Total|Total of all reporting groups
11024616|NCT01177553|FG000|Participant Flow|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
11024617|NCT01177553|FG001|Participant Flow|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
11024618|NCT01177553|OG000|Outcome|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
11024619|NCT01177553|OG001|Outcome|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
11024620|NCT01177553|EG000|Reported Event|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
11024621|NCT01177553|EG001|Reported Event|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
11024622|NCT01177670|BG000|Baseline|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
11024623|NCT01177670|FG000|Participant Flow|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
11024624|NCT01177670|OG000|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
11024625|NCT01177670|EG000|Reported Event|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
11024626|NCT01177709|BG000|Baseline|Metformin|Metformin: metformin 500- 2500 mg/day.
11024627|NCT01177709|FG000|Participant Flow|Metformin|Metformin: metformin 500- 2500 mg/day.
11024628|NCT01177709|OG000|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
11024629|NCT01177709|EG000|Reported Event|Metformin|Metformin: metformin 500- 2500 mg/day.
11024630|NCT01177722|BG000|Baseline|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024631|NCT01177722|BG001|Baseline|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024632|NCT01177722|BG002|Baseline|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024633|NCT01177722|BG003|Baseline|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024634|NCT01177722|BG004|Baseline|Total|Total of all reporting groups
11066341|NCT01391663|OG002|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
11024635|NCT01177722|FG000|Participant Flow|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024636|NCT01177722|FG001|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024637|NCT01177722|FG002|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024638|NCT01177722|FG003|Participant Flow|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024639|NCT01177722|OG000|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024640|NCT01177722|OG001|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024641|NCT01177722|OG002|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024642|NCT01177722|OG003|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024643|NCT01177722|OG003|Outcome|Infanrix Hexa™|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024644|NCT01177722|EG000|Reported Event|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024645|NCT01177722|EG001|Reported Event|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024646|NCT01177722|EG002|Reported Event|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11225801|NCT02370407|OG001|Outcome|Robotic|10 repetitions on robotic task
11024647|NCT01177722|EG003|Reported Event|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
11024648|NCT01177735|BG000|Baseline|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
11066342|NCT01391663|OG003|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
11225802|NCT02370407|OG000|Outcome|Laparoscopic|10 repetitions on the laparoscopic task
11024649|NCT01177735|FG000|Participant Flow|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
11024650|NCT01177735|OG000|Outcome|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
11024651|NCT01177735|EG000|Reported Event|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
11024652|NCT01177787|BG000|Baseline|Zeltiq on Left/Electrical Stimulation on Rt|"Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.~zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.~Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.~electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency."
11024653|NCT01177787|FG000|Participant Flow|Zeltiq on Left/ Electrical Stimulation on Right Thigh|"Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.~zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.~Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.~electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency."
11024654|NCT01177787|OG000|Outcome|Cross Sectional Area on Left Thigh|Cross Sectional Area (mm squares) on Left Thigh by CT
11024655|NCT01177787|OG001|Outcome|Cross Sectional Area on Right Thigh|Cross Sectional Area (mm squares) on Rt thigh by CT
11024656|NCT01177787|OG000|Outcome|Zeltiq on Left|Cryolipolysis using by Zeltiq for 1 hour
11024657|NCT01177787|OG001|Outcome|Electrical Stimulation on Right Side Thigh|The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once
11024658|NCT01177787|OG000|Outcome|The Change of Fat on Left Thigh Between Baseline and 12 Weeks|Comparison of Cross-Sectional Area on Left Thigh by CT between baseline and 12 weeks
11024659|NCT01177787|OG001|Outcome|The Change of Fat Right Thigh Between Baseline and 12 Weeks|Comparison of Cross-Sectional areas on Right thigh by CT between baseline and 12 weeks
11024660|NCT01177787|OG000|Outcome|Zeltiq|zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
11024661|NCT01177787|OG001|Outcome|Electrical Stimulation|electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
11024662|NCT01177787|EG000|Reported Event|Zeltiq|Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
11024663|NCT01177787|EG001|Reported Event|Electrical Stimulation|The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once.
11024664|NCT01177800|BG000|Baseline|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
11024665|NCT01177800|BG001|Baseline|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
11024666|NCT01177800|BG002|Baseline|Total|Total of all reporting groups
11024667|NCT01177800|FG000|Participant Flow|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
11024668|NCT01177800|FG001|Participant Flow|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
11024669|NCT01177800|OG000|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
11024670|NCT01177800|OG001|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
11024671|NCT01177800|EG000|Reported Event|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
11024672|NCT01177800|EG001|Reported Event|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
11066343|NCT01391663|EG000|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
11024673|NCT01177813|BG000|Baseline|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
11024674|NCT01177813|BG001|Baseline|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
11024675|NCT01177813|BG002|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
11024676|NCT01177813|BG003|Baseline|Sitagliptin 100|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
11024677|NCT01177813|BG004|Baseline|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
11024678|NCT01177813|BG005|Baseline|Total|Total of all reporting groups
11024679|NCT01177813|FG000|Participant Flow|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
11024680|NCT01177813|FG001|Participant Flow|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
11024681|NCT01177813|FG002|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
11024682|NCT01177813|FG003|Participant Flow|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
11024683|NCT01177813|FG004|Participant Flow|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
11024684|NCT01177813|OG000|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
11024685|NCT01177813|OG001|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
11024686|NCT01177813|OG002|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
11024687|NCT01177813|OG003|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
10886732|NCT00495794|BG001|Baseline|Usual Care|Eligible patients receive usual care
11024688|NCT01177813|OG004|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
11024689|NCT01177813|EG000|Reported Event|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
11024690|NCT01177813|EG001|Reported Event|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
11024691|NCT01177813|EG002|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
11024692|NCT01177813|EG003|Reported Event|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
10886733|NCT00495794|BG002|Baseline|Total|Total of all reporting groups
11024693|NCT01177813|EG004|Reported Event|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
11024694|NCT01177943|BG000|Baseline|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
11024695|NCT01177943|BG001|Baseline|Atomoxetine Capsule Followed by Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
11024696|NCT01177943|BG002|Baseline|Total|Total of all reporting groups
11024697|NCT01177943|FG000|Participant Flow|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 milligrams (mg) of atomoxetine orally (po), once (12.5 milliliters [mL] at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
11024698|NCT01177943|FG001|Participant Flow|Atomoxetine Capsule Formulation First, Then Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
11024699|NCT01177943|OG000|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
11024700|NCT01177943|OG001|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
11024701|NCT01177943|EG000|Reported Event|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
11024702|NCT01177943|EG001|Reported Event|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
11024703|NCT01177956|BG000|Baseline|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
11024704|NCT01177956|FG000|Participant Flow|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
11024705|NCT01177956|OG000|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
11066344|NCT01391663|EG001|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
11066345|NCT01391663|EG002|Reported Event|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
11024706|NCT01177956|EG000|Reported Event|Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. On or after the first dosing day of trial treatment and until 30 days after the last trial treatment administration.
11024707|NCT01177956|EG001|Reported Event|Cetuximab + Cisplatin + 5-FU : Late Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. Participants with end of treatment date after the last trial treatment date + 30 days or still on trial at the cut-off date.
11024708|NCT01177969|BG000|Baseline|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
11024709|NCT01177969|BG001|Baseline|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
11024710|NCT01177969|BG002|Baseline|Total|Total of all reporting groups
11024711|NCT01177969|FG000|Participant Flow|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
11024712|NCT01177969|FG001|Participant Flow|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
11024713|NCT01177969|OG000|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
11024714|NCT01177969|OG001|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
11024715|NCT01177969|EG000|Reported Event|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
11024716|NCT01177969|EG001|Reported Event|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
11024717|NCT01178073|BG000|Baseline|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024718|NCT01178073|BG001|Baseline|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024719|NCT01178073|BG002|Baseline|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
11024720|NCT01178073|BG003|Baseline|Total|Total of all reporting groups
11066346|NCT01391663|EG003|Reported Event|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
11066347|NCT01391793|BG000|Baseline|Adjuvant Dexamethasone|Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days
11066348|NCT01391793|BG001|Baseline|Placebo|Placebo: Twice daily for 3 days
11066349|NCT01391793|BG002|Baseline|Total|Total of all reporting groups
11024721|NCT01178073|FG000|Participant Flow|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024722|NCT01178073|FG001|Participant Flow|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024723|NCT01178073|FG002|Participant Flow|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
11024724|NCT01178073|OG000|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024725|NCT01178073|OG001|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024726|NCT01178073|OG002|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024727|NCT01178073|OG003|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
11024728|NCT01178073|EG000|Reported Event|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024729|NCT01178073|EG001|Reported Event|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
11024730|NCT01178073|EG002|Reported Event|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
11024731|NCT01178086|BG000|Baseline|Unselected Population (Participants With Any Comorbidity)|Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
11024732|NCT01178086|BG001|Baseline|"Slow Go Subpopulation"|"Slow go subpopulation (participants with cumulative illness rating scale for geriatrics [CIRS-G] score greater than [>] 6 and/or creatinine clearance less than [<] 70 milliliters per minute [mL/min]) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period."
11024733|NCT01178086|BG002|Baseline|Total|Total of all reporting groups
11024734|NCT01178086|FG000|Participant Flow|Participants With Chonic Lymphatic Leukemia (CLL)|Participants with CLL who were treated with intravenous (IV) rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
11024735|NCT01178086|OG000|Outcome|Unselected Population (Participants With Any Comorbidity)|Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
11024736|NCT01178086|OG001|Outcome|"Slow Go Subpopulation"|"Slow go subpopulation (participants with CIRS-G score >6 and/or creatinine clearance <70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period."
11024737|NCT01178086|EG000|Reported Event|Unselected Population (Participants With Any Comorbidity)|Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
11024738|NCT01178086|EG001|Reported Event|"Slow Go Subpopulation"|"Slow go subpopulation (participants with CIRS-G score >6 and/or creatinine clearance <70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period."
11066350|NCT01391793|FG000|Participant Flow|Adjuvant Dexamethasone|Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days
11024739|NCT01178099|BG000|Baseline|Prasugrel 10 mg SD; 5 mg MD (Healthy)|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
11024740|NCT01178099|BG001|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Healthy)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
11024741|NCT01178099|BG002|Baseline|Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (MD).
11024742|NCT01178099|BG003|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
11024743|NCT01178099|BG004|Baseline|Total|Total of all reporting groups
11024744|NCT01178099|FG000|Participant Flow|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
11024745|NCT01178099|FG001|Participant Flow|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
11024746|NCT01178099|OG000|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
11024747|NCT01178099|OG001|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
11024748|NCT01178099|EG000|Reported Event|Prasugrel 10/5 mg Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
11024749|NCT01178099|EG001|Reported Event|Prasugrel 10/7.5 mg Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
11024750|NCT01178099|EG002|Reported Event|All Prasugrel Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
11024751|NCT01178099|EG003|Reported Event|Prasugrel 10/5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kg) for an additional 11 days (MD).
11024752|NCT01178099|EG004|Reported Event|Prasugrel 10/7.5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
11024753|NCT01178099|EG005|Reported Event|All Prasugrel Sickle Cell Disease Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
11024754|NCT01178125|BG000|Baseline|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
11024755|NCT01178125|FG000|Participant Flow|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
11024756|NCT01178125|OG000|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
11024757|NCT01178125|OG001|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
11024758|NCT01178125|OG002|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
11024759|NCT01178125|OG000|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
11024760|NCT01178125|OG000|Outcome|DR-102: Baseline|prior to starting desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
11024761|NCT01178125|OG001|Outcome|DR-102: Endpoint|at Week 51 of treatment with desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
11024762|NCT01178125|EG000|Reported Event|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
11024763|NCT01178138|BG000|Baseline|Prazosin Effects on Methamphetamine|"The order of placebo vs. active medication will be randomized.~oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.~General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.~Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri).~Oral placebo + methamphetamine (0, 15, 15 mg/70 kg)~Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg)~Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
11024764|NCT01178138|FG000|Participant Flow|Prazosin Effects on Methamphetamine|"Double blind, placebo controlled study of the effect of prazosin on methamphetamine~The order of placebo vs. active medication will be randomized.~oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.~General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.~Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri).~Oral placebo + methamphetamine (0, 15, 15 mg/70 kg) Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg) Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
11024765|NCT01178138|OG000|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
11024766|NCT01178138|OG001|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
11024767|NCT01178138|OG002|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
11024768|NCT01178138|OG003|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
11024769|NCT01178138|OG004|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
11024770|NCT01178138|OG005|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
11024771|NCT01178138|EG000|Reported Event|Prazosin Effects on Methamphetamine|Randomized placebo controlled trial of prazosin effects on methamphetamine
11024772|NCT01178216|BG000|Baseline|Rituxan|"All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.~Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present."
11024773|NCT01178216|FG000|Participant Flow|Rituxan|"All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.~Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present."
11024774|NCT01178216|OG000|Outcome|Rituxan|"All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.~Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present."
11024775|NCT01178216|EG000|Reported Event|Rituxan|"All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.~Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present."
11024776|NCT01178268|BG000|Baseline|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
11024777|NCT01178268|BG001|Baseline|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
11024778|NCT01178268|BG002|Baseline|Total|Total of all reporting groups
11024779|NCT01178268|FG000|Participant Flow|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
11024780|NCT01178268|FG001|Participant Flow|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
11024781|NCT01178268|OG000|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
11024782|NCT01178268|OG001|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
11024783|NCT01178268|EG000|Reported Event|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
11024784|NCT01178268|EG001|Reported Event|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
11024785|NCT01178281|BG000|Baseline|Pomalidomide 0.5 mg|Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects or disease progression. Participants who experienced clinical benefit (defined as a reduction from Baseline of ≥ 50% in RBC-transfusion frequency during the prior 84-day interval) could continue to receive pomalidomide until the definition of clinical benefit was no longer met or other criteria for treatment discontinuation applied.
11024786|NCT01178281|BG001|Baseline|Placebo|"Participants received placebo taken by mouth once daily for at least 168 days unless there were unacceptable side effects or disease progression.~Participants who were RBC-transfusion independent or experienced clinical benefit could continue to receive placebo until loss of RBC-transfusion independence response or clinical benefit, or other criteria for treatment discontinuation applied."
11024787|NCT01178281|BG002|Baseline|China Extension: Pomalidomide 0.5 mg|Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects, disease progression, or they received a RBC-transfusion. Participants who experienced anemia response could continue treatment until the response was lost or other criteria for treatment discontinuation applied.
11024788|NCT01178281|BG003|Baseline|Total|Total of all reporting groups
11024789|NCT01178281|FG000|Participant Flow|Pomalidomide 0.5 mg|"Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects or disease progression.~Participants who were RBC-transfusion independent or experienced clinical benefit (defined as a reduction from Baseline of ≥ 50% in RBC-transfusion frequency during the prior 84-day interval) could continue to receive pomalidomide until loss of RBC-transfusion independence response or clinical benefit, or other criteria for treatment discontinuation applied."
11024790|NCT01178281|FG001|Participant Flow|Placebo|"Participants received placebo taken by mouth once daily for at least 168 days unless there were unacceptable side effects or disease progression.~Participants who were RBC-transfusion independent or experienced clinical benefit could continue to receive placebo until loss of RBC-transfusion independence response or clinical benefit, or other criteria for treatment discontinuation applied."
11024791|NCT01178281|FG002|Participant Flow|China Extension: Pomalidomide 0.5 mg|Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects, disease progression, or they received a RBC-transfusion. Participants who experienced anemia response could continue treatment until the response was lost or other criteria for treatment discontinuation applied.
11024792|NCT01178281|OG000|Outcome|Pomalidomide 0.5 mg|"Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects or disease progression.~Participants who were RBC-transfusion independent or experienced clinical benefit could continue to receive pomalidomide until loss of RBC-transfusion independence response or clinical benefit, or other criteria for treatment discontinuation applied."
11024793|NCT01178281|OG001|Outcome|Placebo|"Participants received placebo taken by mouth once daily for at least 168 days unless there were unacceptable side effects or disease progression.~Participants who were RBC-transfusion independent or experienced clinical benefit could continue to receive placebo until loss of RBC-transfusion independence response or clinical benefit, or other criteria for treatment discontinuation applied."
11024794|NCT01178281|OG000|Outcome|China Extension: Pomalidomide 0.5 mg|Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects, disease progression, or they received a RBC-transfusion.
11024795|NCT01178281|OG000|Outcome|Pomalidomide 0.5 mg|Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects or disease progression.
11024796|NCT01178281|OG002|Outcome|China Extension: Pomalidomide 0.5 mg|Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects, disease progression, or they received a RBC-transfusion.
11024797|NCT01178281|EG000|Reported Event|Global Study: Pomalidomide 0.5 mg|Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects or disease progression. Participants who experienced clinical benefit (defined as a reduction from Baseline of ≥ 50% in RBC-transfusion frequency during the prior 84-day interval) could continue to receive pomalidomide until the definition of clinical benefit was no longer met or other criteria for treatment discontinuation applied.
11024798|NCT01178281|EG001|Reported Event|Global Study: Placebo|Participants received placebo taken by mouth once daily for at least 168 days unless there were unacceptable side effects or disease progression. Participants who experienced clinical benefit could continue to receive placebo until the definition of clinical benefit was no longer met or other criteria for treatment discontinuation applied.
11024799|NCT01178281|EG002|Reported Event|China Extension: Pomalidomide 0.5 mg|Participants received pomalidomide 0.5 mg/day by mouth for at least 168 days unless there were unacceptable side effects, disease progression, or they received a RBC-transfusion. Participants who experienced anemia response could continue treatment until the response was lost or other criteria for treatment discontinuation applied.
11024800|NCT01178294|BG000|Baseline|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
11024801|NCT01178294|FG000|Participant Flow|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
11024802|NCT01178294|OG000|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
11024803|NCT01178294|EG000|Reported Event|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
11024804|NCT01178333|BG000|Baseline|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
11024805|NCT01178333|BG001|Baseline|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
11024806|NCT01178333|BG002|Baseline|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
11024807|NCT01178333|BG003|Baseline|Total|Total of all reporting groups
11024808|NCT01178333|FG000|Participant Flow|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
11024809|NCT01178333|FG001|Participant Flow|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
11024810|NCT01178333|FG002|Participant Flow|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
11024811|NCT01178333|OG000|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
11024812|NCT01178333|OG001|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
11024813|NCT01178333|OG002|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
11024814|NCT01178333|OG000|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
11024815|NCT01178333|OG001|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
11024816|NCT01178333|EG000|Reported Event|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
11024817|NCT01178333|EG001|Reported Event|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
11225803|NCT02370407|OG001|Outcome|Robotic Task|10 repetitions on the robotic task
11024818|NCT01178333|EG002|Reported Event|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
11024819|NCT01178385|BG000|Baseline|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
11024820|NCT01178385|BG001|Baseline|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
11024821|NCT01178385|BG002|Baseline|Total|Total of all reporting groups
11024822|NCT01178385|FG000|Participant Flow|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
11024823|NCT01178385|FG001|Participant Flow|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
11024824|NCT01178385|OG000|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
11024825|NCT01178385|OG001|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
11024826|NCT01178385|EG000|Reported Event|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
11024827|NCT01178385|EG001|Reported Event|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
11024828|NCT01178411|BG000|Baseline|Tivantinib (Monotherapy or Combination)|Participants received tivantinib 360 mg twice daily by mouth as monotherapy or combination therapy.
11024829|NCT01178411|FG000|Participant Flow|Tivantinib (Monotherapy or Combination)|Participants received tivantinib 360 mg twice daily by mouth as monotherapy or combination therapy.
11024830|NCT01178411|OG000|Outcome|Tivantinib (Monotherapy or Combination)|Participants received tivantinib 360 mg twice daily by mouth as monotherapy or combination therapy.
11024831|NCT01178411|EG000|Reported Event|Tivantinib (Monotherapy or Combination)|Participants received tivantinib 360 mg twice daily by mouth as monotherapy or combination therapy.
11024832|NCT01178528|BG000|Baseline|Ivabradine|up to 7.5 mg b.i.d.
11024833|NCT01178528|BG001|Baseline|Carvedilol|up to 25 mg b.i.d.
11024834|NCT01178528|BG002|Baseline|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
11024835|NCT01178528|BG003|Baseline|Total|Total of all reporting groups
11024836|NCT01178528|FG000|Participant Flow|Ivabradine|up to 7.5 mg b.i.d.
11024837|NCT01178528|FG001|Participant Flow|Carvedilol|up to 25 mg b.i.d.
11024838|NCT01178528|FG002|Participant Flow|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
11024839|NCT01178528|OG000|Outcome|Ivabradine|up to 7.5 mg b.i.d.
11024840|NCT01178528|OG001|Outcome|Carvedilol|up to 25 mg b.i.d.
11024841|NCT01178528|OG002|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
11024842|NCT01178528|OG000|Outcome|Ivabradine|7.5 mg b.i.d.
11024843|NCT01178528|EG000|Reported Event|Ivabradine|up to 7.5 mg b.i.d.
11024844|NCT01178528|EG001|Reported Event|Carvedilol|up to 25 mg b.i.d.
11024845|NCT01178528|EG002|Reported Event|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
11024846|NCT01178671|BG000|Baseline|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
11024847|NCT01178671|BG001|Baseline|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
11024848|NCT01178671|BG002|Baseline|Total|Total of all reporting groups
11066351|NCT01391793|FG001|Participant Flow|Placebo|Placebo: Twice daily for 3 days
11066352|NCT01391793|OG000|Outcome|Adjuvant Dexamethasone|Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days
11024849|NCT01178671|FG000|Participant Flow|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
11024850|NCT01178671|FG001|Participant Flow|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
11024851|NCT01178671|OG000|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
11024852|NCT01178671|OG001|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
11024853|NCT01178671|EG000|Reported Event|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
11024854|NCT01178671|EG001|Reported Event|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
11024855|NCT01178762|BG000|Baseline|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
11024856|NCT01178762|FG000|Participant Flow|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
11024857|NCT01178762|OG000|Outcome|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
11024858|NCT01178762|EG000|Reported Event|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
11024859|NCT01178827|BG000|Baseline|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
11024860|NCT01178827|BG001|Baseline|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
11024861|NCT01178827|BG002|Baseline|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
11024862|NCT01178827|BG003|Baseline|Total|Total of all reporting groups
11024863|NCT01178827|FG000|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride), 60mg once daily for 10 days
11024864|NCT01178827|FG001|Participant Flow|Oxybutynin IR|Oxybutynin IR (oxybutynin immediate release) 5 mg, three times daily for 2 days
11024865|NCT01178827|FG002|Participant Flow|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
11024866|NCT01178827|OG000|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
11024867|NCT01178827|OG001|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
11024868|NCT01178827|OG002|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
11024869|NCT01178827|EG000|Reported Event|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
11024870|NCT01178827|EG001|Reported Event|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
11024871|NCT01178827|EG002|Reported Event|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
11024872|NCT01178853|BG000|Baseline|Pitavastatin/Rosuvastatin|
11024873|NCT01178853|BG001|Baseline|Rosuvastatin/Pitavastatin|
11024874|NCT01178853|BG002|Baseline|Total|Total of all reporting groups
11024875|NCT01178853|FG000|Participant Flow|Pitavastatin/Rosuvastatin|
11024876|NCT01178853|FG001|Participant Flow|Rosuvastatin/Pitavastatin|
11024877|NCT01178853|OG000|Outcome|Warfarin + Pitavastatin|
11024878|NCT01178853|OG001|Outcome|Warfarin + Rosuvastatin|
11024879|NCT01178853|EG000|Reported Event|Warfarin + Pitavastatin|
11024880|NCT01178853|EG001|Reported Event|Warfarin + Rosuvastatin|
11024881|NCT01178944|BG000|Baseline|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
11066353|NCT01391793|OG001|Outcome|Placebo|Placebo: Twice daily for 3 days
11066354|NCT01391793|EG000|Reported Event|Adjuvant Dexamethasone|Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days
11024882|NCT01178944|FG000|Participant Flow|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
11024883|NCT01178944|OG000|Outcome|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
11024884|NCT01178944|EG000|Reported Event|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
11024885|NCT01179048|BG000|Baseline|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
11024886|NCT01179048|BG001|Baseline|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
11024887|NCT01179048|BG002|Baseline|Total|Total of all reporting groups
11024888|NCT01179048|FG000|Participant Flow|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
11024889|NCT01179048|FG001|Participant Flow|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
11024890|NCT01179048|OG000|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
11024891|NCT01179048|OG001|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
11024892|NCT01179048|EG000|Reported Event|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
11024893|NCT01179048|EG001|Reported Event|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
11024894|NCT01179113|BG000|Baseline|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
11024895|NCT01179113|BG001|Baseline|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
11024896|NCT01179113|BG002|Baseline|Total|Total of all reporting groups
11024897|NCT01179113|FG000|Participant Flow|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
11024898|NCT01179113|FG001|Participant Flow|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
11024899|NCT01179113|OG000|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
11024900|NCT01179113|OG001|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
11024901|NCT01179113|EG000|Reported Event|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
11024902|NCT01179113|EG001|Reported Event|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
11024903|NCT01179191|BG000|Baseline|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
11024904|NCT01179191|FG000|Participant Flow|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
11066355|NCT01391793|EG001|Reported Event|Placebo|Placebo: Twice daily for 3 days
11024905|NCT01179191|OG000|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
11024906|NCT01179191|EG000|Reported Event|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
11024907|NCT01179217|BG000|Baseline|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
11024908|NCT01179217|BG001|Baseline|Placebo|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
11024909|NCT01179217|BG002|Baseline|Total|Total of all reporting groups
11024910|NCT01179217|FG000|Participant Flow|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
11024911|NCT01179217|FG001|Participant Flow|Placebo|"Patients will be randomized to receive Placebo.~Placebo (100% maltodextrin): 0.3 g/kg of placebo will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
11024912|NCT01179217|OG000|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
11024913|NCT01179217|OG001|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
11024914|NCT01179217|OG001|Outcome|Placebo|"Patients will be randomized to receive Placebo.~Placebo (100% maltodextrin): 0.3 g/kg of placebo will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
11024915|NCT01179217|OG001|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
11024916|NCT01179217|EG000|Reported Event|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
11024917|NCT01179217|EG001|Reported Event|100% Maltodextrin|"Patients will be randomized to receive Placebo.~100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
11024918|NCT01179334|BG000|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
11024919|NCT01179334|BG001|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
11024920|NCT01179334|BG002|Baseline|Total|Total of all reporting groups
11024921|NCT01179334|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
11024922|NCT01179334|FG001|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
11024923|NCT01179334|OG000|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
11024924|NCT01179334|OG001|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
11024925|NCT01179334|EG000|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
11024926|NCT01179334|EG001|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
11024927|NCT01179347|BG000|Baseline|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
11024928|NCT01179347|BG001|Baseline|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
11024929|NCT01179347|BG002|Baseline|Total|Total of all reporting groups
11024930|NCT01179347|FG000|Participant Flow|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
11024931|NCT01179347|FG001|Participant Flow|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
11024932|NCT01179347|OG000|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
11024933|NCT01179347|OG001|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
11024934|NCT01179347|EG000|Reported Event|Placebo Randomized Group Over the Double-Blind Period|
11024935|NCT01179347|EG001|Reported Event|Tio 5mcg Randomized Group Over the Double-Blind Period|
11024936|NCT01179347|EG002|Reported Event|Placebo Randomized Group Over the Open-Label Period|
11024937|NCT01179347|EG003|Reported Event|Tio 5mcg Randomized Group Over the Study|
11024938|NCT01179477|BG000|Baseline|Subjects Implanted With a New QuickFlex μ Lead|Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years.
11024939|NCT01179477|FG000|Participant Flow|Subjects Implanted With a New QuickFlex μ Lead|Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years.
11024940|NCT01179477|OG000|Outcome|Subjects Implanted With a New QuickFlex μ Lead|Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
11024941|NCT01179477|EG000|Reported Event|Subjects Implanted With a New QuickFlex μ Lead|Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
11024942|NCT01179490|BG000|Baseline|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
11066356|NCT01391819|BG000|Baseline|Dengue Group|Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
11066357|NCT01391819|FG000|Participant Flow|Dengue Group|Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
11024943|NCT01179490|FG000|Participant Flow|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
11024944|NCT01179490|OG000|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
11024945|NCT01179490|EG000|Reported Event|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
11024946|NCT01179516|BG000|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
11024947|NCT01179516|BG001|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
11024948|NCT01179516|BG002|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
11024949|NCT01179516|BG003|Baseline|Total|Total of all reporting groups
11024950|NCT01179516|FG000|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
11024951|NCT01179516|FG001|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
11024952|NCT01179516|FG002|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
11024953|NCT01179516|OG000|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
11024954|NCT01179516|OG001|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
11024955|NCT01179516|OG002|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
11024956|NCT01179516|EG000|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
11024957|NCT01179516|EG001|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
11024958|NCT01179516|EG002|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
11024959|NCT01179568|BG000|Baseline|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024960|NCT01179568|BG001|Baseline|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
11024961|NCT01179568|BG002|Baseline|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024962|NCT01179568|BG003|Baseline|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
11024963|NCT01179568|BG004|Baseline|Total|Total of all reporting groups
11024964|NCT01179568|FG000|Participant Flow|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024965|NCT01179568|FG001|Participant Flow|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
11024966|NCT01179568|FG002|Participant Flow|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024967|NCT01179568|FG003|Participant Flow|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
11024968|NCT01179568|OG000|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024969|NCT01179568|OG001|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
11024970|NCT01179568|OG002|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024971|NCT01179568|OG003|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
11024972|NCT01179568|OG001|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
11024973|NCT01179568|OG001|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024974|NCT01179568|OG002|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
11024975|NCT01179568|EG000|Reported Event|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024976|NCT01179568|EG001|Reported Event|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
11024977|NCT01179568|EG002|Reported Event|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
11024978|NCT01179568|EG003|Reported Event|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
11024979|NCT01179672|BG000|Baseline|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1 then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
11024980|NCT01179672|BG001|Baseline|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
11024981|NCT01179672|BG002|Baseline|Total|Total of all reporting groups
11024982|NCT01179672|FG000|Participant Flow|Duloxetine|30 milligrams (mg) duloxetine capsule administered orally, once daily (QD) during Week 1 then 60 mg duloxetine capsule orally, QD for the remaining 11 weeks of treatment. After a total 12 weeks of treatment or early discontinuation participants tapered off study drug (30 mg duloxetine capsule QD) for 1 week during taper.
11024983|NCT01179672|FG001|Participant Flow|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
11024984|NCT01179672|OG000|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
11024985|NCT01179672|OG001|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
11024986|NCT01179672|OG000|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
11024987|NCT01179672|OG000|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper
11024988|NCT01179672|EG000|Reported Event|Duloxetine Treatment|30 mg duloxetine capsule administered orally, QD during Week 1 of the treatment; 60 mg capsule administered orally, QD for remaining 11 weeks of the treatment;
11024989|NCT01179672|EG001|Reported Event|Placebo Treatment|Placebo administered orally, QD for 12 weeks of the treatment.
11024990|NCT01179672|EG002|Reported Event|Duloxetine Taper|After 12 weeks of treatment or early discontinuation, 30 mg duloxetine capsule administered orally, QD for 1 week during taper.
11024991|NCT01179672|EG003|Reported Event|Placebo Taper|After 12 weeks of treatment or early discontinuation, placebo administered orally, QD for 1 week during taper.
11024992|NCT01179919|BG000|Baseline|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
11024993|NCT01179919|FG000|Participant Flow|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
11024994|NCT01179919|OG000|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
11024995|NCT01179919|EG000|Reported Event|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
11024996|NCT01179984|BG000|Baseline|Single-Arm|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
11024997|NCT01179984|FG000|Participant Flow|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
11024998|NCT01179984|OG000|Outcome|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
11024999|NCT01179984|OG000|Outcome|Single-Arm|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
11025000|NCT01179984|EG000|Reported Event|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
11025001|NCT01180036|BG000|Baseline|Rituximab Treatment Arm|"Patients randomized to the RTX arm will receive 1000 mg IV on Days 1 and 15. Patients who achieve complete remission at 6 months will not be retreated. A second course of RTX 1000 mg IV will be administered at study month 6 for individuals who have not achieved a complete remission, but have achieved a minimum of >25% reduction in Time 0 proteinuria. Dosing at study month 6 will be independent of CD19+ B cell count.~Rituximab: 1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of CD19+ B cell count"
11025002|NCT01180036|BG001|Baseline|Cyclosporine Treatment Arm|Patients randomized to the Cyclosporine arm will be started at a dose of CsA = 3.5 mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Target trough CsA blood levels are 125 to 175 ng/ml. Patients will have their doses adjusted according to their blood levels of CSA as monitored every 2 weeks until the target trough level is reached. If a complete remission is achieved by 6 months, CSA will be tapered and discontinued over a three-month period. If after 6 months there has not been a reduction in proteinuria of at least 25% of baseline values, the drug will also be discontinued. If there has been a >25% reduction in baseline proteinuria (but not complete remission) the CSA will be continued for an additional 6 months.
11025003|NCT01180036|BG002|Baseline|Total|Total of all reporting groups
11025004|NCT01180036|FG000|Participant Flow|Rituximab Treatment Arm|"Patients randomized to the RTX arm will receive 1000 mg IV on Days 1 and 15. Patients who achieve complete remission at 6 months will not be retreated. A second course of RTX 1000 mg IV will be administered at study month 6 for individuals who have not achieved a complete remission, but have achieved a minimum of >25% reduction in Time 0 proteinuria. Dosing at study month 6 will be independent of CD19+ B cell count.~Rituximab: 1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of CD19+ B cell count"
11025005|NCT01180036|FG001|Participant Flow|Cyclosporine Treatment Arm|Patients randomized to the Cyclosporine arm will be started at a dose of CsA = 3.5 mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Target trough CsA blood levels are 125 to 175 ng/ml. Patients will have their doses adjusted according to their blood levels of CSA as monitored every 2 weeks until the target trough level is reached. If a complete remission is achieved by 6 months, CSA will be tapered and discontinued over a three-month period. If after 6 months there has not been a reduction in proteinuria of at least 25% of baseline values, the drug will also be discontinued. If there has been a >25% reduction in baseline proteinuria (but not complete remission) the CSA will be continued for an additional 6 months.
11025006|NCT01180036|OG000|Outcome|Rituximab Treatment Arm|"Patients randomized to the Rituximab (RTX) arm will receive 1000 mg IV on Days 1 and 15. Patients who achieve complete remission at 6 months will not be retreated. A second course of RTX 1000 mg IV will be administered at study month 6 for individuals who have not achieved a complete remission, but have achieved a minimum of >25% reduction in Time 0 proteinuria. Dosing at study month 6 will be independent of Cluster of Differentiation 19 (CD19)+ B cell count.~Rituximab: 1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of CD19+ B cell count"
11150214|NCT01876381|FG000|Participant Flow|OPC-41061|Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
11150215|NCT01876381|OG000|Outcome|OPC-41061|Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
11025007|NCT01180036|OG001|Outcome|Cyclosporine Treatment Arm|Patients randomized to the Cyclosporine (CsA) arm will be started at a dose of CsA = 3.5 mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Target trough CsA blood levels are 125 to 175 ng/ml. Patients will have their doses adjusted according to their blood levels of CSA as monitored every 2 weeks until the target trough level is reached. If a complete remission is achieved by 6 months, CSA will be tapered and discontinued over a three-month period. If after 6 months there has not been a reduction in proteinuria of at least 25% of baseline values, the drug will also be discontinued. If there has been a >25% reduction in baseline proteinuria (but not complete remission) the CSA will be continued for an additional 6 months.
11025008|NCT01180036|OG000|Outcome|Rituximab Treatment Arm|"Patients randomized to the RTX arm will receive 1000 mg IV on Days 1 and 15. Patients who achieve complete remission at 6 months will not be retreated. A second course of RTX 1000 mg IV will be administered at study month 6 for individuals who have not achieved a complete remission, but have achieved a minimum of >25% reduction in Time 0 proteinuria. Dosing at study month 6 will be independent of CD19+ B cell count.~Rituximab: 1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of CD19+ B cell count"
11025009|NCT01180036|OG001|Outcome|Cyclosporine Treatment Arm|Patients randomized to the Cyclosporine arm will be started at a dose of CsA = 3.5 mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Target trough CsA blood levels are 125 to 175 ng/ml. Patients will have their doses adjusted according to their blood levels of CSA as monitored every 2 weeks until the target trough level is reached. If a complete remission is achieved by 6 months, CSA will be tapered and discontinued over a three-month period. If after 6 months there has not been a reduction in proteinuria of at least 25% of baseline values, the drug will also be discontinued. If there has been a >25% reduction in baseline proteinuria (but not complete remission) the CSA will be continued for an additional 6 months.
11025010|NCT01180036|EG000|Reported Event|Rituximab Treatment Arm|"Patients randomized to the RTX arm will receive 1000 mg IV on Days 1 and 15. Patients who achieve complete remission at 6 months will not be retreated. A second course of RTX 1000 mg IV will be administered at study month 6 for individuals who have not achieved a complete remission, but have achieved a minimum of >25% reduction in Time 0 proteinuria. Dosing at study month 6 will be independent of CD19+ B cell count.~Rituximab: 1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of CD19+ B cell count"
11025011|NCT01180036|EG001|Reported Event|Cyclosporine Treatment Arm|Patients randomized to the Cyclosporine arm will be started at a dose of CsA = 3.5 mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Target trough CsA blood levels are 125 to 175 ng/ml. Patients will have their doses adjusted according to their blood levels of CSA as monitored every 2 weeks until the target trough level is reached. If a complete remission is achieved by 6 months, CSA will be tapered and discontinued over a three-month period. If after 6 months there has not been a reduction in proteinuria of at least 25% of baseline values, the drug will also be discontinued. If there has been a >25% reduction in baseline proteinuria (but not complete remission) the CSA will be continued for an additional 6 months.
11025012|NCT01180049|BG000|Baseline|TEMSR 175/75 mg|Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
11025013|NCT01180049|BG001|Baseline|TEMSR 75 mg|Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
11025014|NCT01180049|BG002|Baseline|Total|Total of all reporting groups
11025015|NCT01180049|FG000|Participant Flow|TEMSR 175/75 mg|Participants had received desipramine 50 milligrams (mg) one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
11025016|NCT01180049|FG001|Participant Flow|TEMSR 75 mg|Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
11025017|NCT01180049|OG000|Outcome|TEMSR 175/75 mg|Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
11025018|NCT01180049|OG001|Outcome|TEMSR 75 mg|Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
11025019|NCT01180049|EG000|Reported Event|TEMSR 175/75 mg|Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
11025020|NCT01180049|EG001|Reported Event|TEMSR 75 mg|Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
11025021|NCT01180127|BG000|Baseline|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
11025022|NCT01180127|BG001|Baseline|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025023|NCT01180127|BG002|Baseline|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
11025024|NCT01180127|BG003|Baseline|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025025|NCT01180127|BG004|Baseline|Total|Total of all reporting groups
11025026|NCT01180127|FG000|Participant Flow|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
11025027|NCT01180127|FG001|Participant Flow|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025028|NCT01180127|FG002|Participant Flow|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
11025029|NCT01180127|FG003|Participant Flow|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025030|NCT01180127|OG000|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
11025031|NCT01180127|OG001|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025032|NCT01180127|OG002|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
11025033|NCT01180127|OG003|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025034|NCT01180127|OG000|Outcome|Exercise, Dietary Intervention|"aerobic training and flavonol containing food product~Flavonol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
11025035|NCT01180127|OG001|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavonol containing food product for 12 weeks~Flavonol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025036|NCT01180127|OG002|Outcome|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavonol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol"
11025037|NCT01180127|OG003|Outcome|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavonol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025038|NCT01180127|EG000|Reported Event|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
11025039|NCT01180127|EG001|Reported Event|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025040|NCT01180127|EG002|Reported Event|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
11025041|NCT01180127|EG003|Reported Event|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
11025042|NCT01180244|BG000|Baseline|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
11025043|NCT01180244|BG001|Baseline|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
11025044|NCT01180244|BG002|Baseline|Total|Total of all reporting groups
11066358|NCT01391819|OG000|Outcome|Dengue 5-9Y Group|Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
11066359|NCT01391819|OG001|Outcome|Dengue 10-17Y Group|Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
11066360|NCT01391819|OG000|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
11066361|NCT01391819|OG000|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
10886734|NCT00495794|FG000|Participant Flow|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
10886735|NCT00495794|FG001|Participant Flow|Usual Care|Eligible patients receive usual care
10886736|NCT00495794|OG000|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
11025045|NCT01180244|FG000|Participant Flow|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
11025046|NCT01180244|FG001|Participant Flow|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
11025047|NCT01180244|OG000|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
11025048|NCT01180244|OG001|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
11025049|NCT01180244|EG000|Reported Event|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
11025050|NCT01180244|EG001|Reported Event|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
11025051|NCT01180296|BG000|Baseline|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
11025052|NCT01180296|BG001|Baseline|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
11025053|NCT01180296|BG002|Baseline|Total|Total of all reporting groups
11025054|NCT01180296|FG000|Participant Flow|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
11025055|NCT01180296|FG001|Participant Flow|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
10886737|NCT00495794|OG001|Outcome|Usual Care|Eligible patients receive usual care
10886738|NCT00495794|EG000|Reported Event|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
11025056|NCT01180296|OG000|Outcome|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
11025057|NCT01180296|OG001|Outcome|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
11025058|NCT01180296|OG000|Outcome|Progesterone Group|oral micronized progesterone: 400 mg oral micronized progesterone nightly from 16 to 34 weeks vs placebo
11025059|NCT01180296|OG001|Outcome|Placebo|Identical Placebo tablet: placebo taking nightly from 16 to 34 weeks
11025060|NCT01180296|EG000|Reported Event|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
11025061|NCT01180296|EG001|Reported Event|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
11025062|NCT01180400|BG000|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11025063|NCT01180400|BG001|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11025064|NCT01180400|BG002|Baseline|Total|Total of all reporting groups
11025065|NCT01180400|FG000|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11025066|NCT01180400|FG001|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11025067|NCT01180400|OG000|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11025068|NCT01180400|OG001|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11025069|NCT01180400|EG000|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
11025070|NCT01180400|EG001|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11025071|NCT01180478|BG000|Baseline|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
11025072|NCT01180478|BG001|Baseline|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
11025073|NCT01180478|BG002|Baseline|Total|Total of all reporting groups
11025074|NCT01180478|FG000|Participant Flow|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
10886739|NCT00495794|EG001|Reported Event|Usual Care|Eligible patients receive usual care
11025075|NCT01180478|FG001|Participant Flow|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
11025076|NCT01180478|OG000|Outcome|Narrow Band Imaging|
11025077|NCT01180478|OG001|Outcome|White Light|
11025078|NCT01180478|OG000|Outcome|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
11025079|NCT01180478|OG001|Outcome|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
11025080|NCT01180478|EG000|Reported Event|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
11025081|NCT01180478|EG001|Reported Event|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
11025082|NCT01180647|BG000|Baseline|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
11025083|NCT01180647|BG001|Baseline|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
11025084|NCT01180647|BG002|Baseline|Total|Total of all reporting groups
11025085|NCT01180647|FG000|Participant Flow|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
11025086|NCT01180647|FG001|Participant Flow|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
11025087|NCT01180647|OG000|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
11025088|NCT01180647|OG001|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
11025089|NCT01180647|EG000|Reported Event|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
11025090|NCT01180647|EG001|Reported Event|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
11025091|NCT01180660|BG000|Baseline|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
11025092|NCT01180660|BG001|Baseline|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
11025093|NCT01180660|BG002|Baseline|Total|Total of all reporting groups
11025094|NCT01180660|FG000|Participant Flow|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
11025095|NCT01180660|FG001|Participant Flow|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
10886740|NCT00495820|BG000|Baseline|Arm 1|"Methylphenidate~Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
10886741|NCT00495820|BG001|Baseline|Arm 2|"Placebo~Placebo: Standard inactive pill."
11025096|NCT01180660|OG000|Outcome|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
11025097|NCT01180660|OG001|Outcome|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
11025098|NCT01180660|EG000|Reported Event|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
11025099|NCT01180660|EG001|Reported Event|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
11025100|NCT01180777|BG000|Baseline|All Subjects|Subjects were to wear all three lenses over the course of the study.
11025101|NCT01180777|FG000|Participant Flow|All Subjects|All subjects who enrolled, randomized, and exposed to the study lenses. Subjects where randomized to a study arm and wore all three of the study lenses by study completion. Randomization was to the arms as outlined in the 'arms' section of the protocol.
11025102|NCT01180777|OG000|Outcome|Etafilcon A (A)|Daily wear contact lens
11025103|NCT01180777|OG001|Outcome|Etafilcon A (B)|Daily wear contact lens
11025104|NCT01180777|OG002|Outcome|Etafilcon A (C)|Daily wear contact lens
11025105|NCT01180777|EG000|Reported Event|All Subjects|Subjects were to wear all three lenses over the course of the study. Due to the non-ocular related AE, all subjects are summarized to report the occurrence of event.
11025106|NCT01180790|BG000|Baseline|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025107|NCT01180790|BG001|Baseline|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
10886742|NCT00495820|BG002|Baseline|Total|Total of all reporting groups
11025108|NCT01180790|BG002|Baseline|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025109|NCT01180790|BG003|Baseline|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
10886743|NCT00495820|FG000|Participant Flow|Arm 1|"Methylphenidate~Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
11025110|NCT01180790|BG004|Baseline|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025111|NCT01180790|BG005|Baseline|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025112|NCT01180790|BG006|Baseline|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025113|NCT01180790|BG007|Baseline|Total|Total of all reporting groups
11025114|NCT01180790|FG000|Participant Flow|Segment 1: 200 mg ACH-0141625 for 28 Days|"ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025115|NCT01180790|FG001|Participant Flow|Segment 1: 400 mg ACH-0141625 for 28 Days|"ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025116|NCT01180790|FG002|Participant Flow|Segment 1: 800 mg ACH-0141625 for 28 Days|"ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025117|NCT01180790|FG003|Participant Flow|Segment 1: Placebo for 28 Days|"Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025118|NCT01180790|FG004|Participant Flow|Segment 2: 200 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
11025119|NCT01180790|FG005|Participant Flow|Segment 2 - 400 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
11066362|NCT01391819|EG000|Reported Event|Dengue Group|Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
10886744|NCT00495820|FG001|Participant Flow|Arm 2|"Placebo~Placebo: Standard inactive pill."
11025120|NCT01180790|FG006|Participant Flow|Segment 2 - 800 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
11025121|NCT01180790|OG000|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025122|NCT01180790|OG001|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025123|NCT01180790|OG002|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025124|NCT01180790|OG003|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025125|NCT01180790|OG001|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025126|NCT01180790|OG000|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025127|NCT01180790|OG001|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025128|NCT01180790|OG002|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025129|NCT01180790|OG000|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025130|NCT01180790|OG001|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
10886745|NCT00495820|OG000|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
11025131|NCT01180790|OG002|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025132|NCT01180790|OG000|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025133|NCT01180790|OG001|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025134|NCT01180790|OG002|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025135|NCT01180790|OG003|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025136|NCT01180790|OG000|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025137|NCT01180790|OG001|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025138|NCT01180790|OG002|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
10886746|NCT00495820|OG001|Outcome|Placebo Group|Subjects randomized to this group received placebo
10886747|NCT00495820|EG000|Reported Event|Methylphenidate Group|Subjects randomized to this group received methylphenidate
10886748|NCT00495820|EG001|Reported Event|Placebo Group|Subjects randomized to this group received methylphenidate
11025139|NCT01180790|OG003|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025140|NCT01180790|OG004|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025141|NCT01180790|OG005|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025142|NCT01180790|OG006|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025143|NCT01180790|OG001|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025144|NCT01180790|OG004|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily for~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025145|NCT01180790|OG005|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025146|NCT01180790|OG006|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025147|NCT01180790|OG000|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025148|NCT01180790|OG001|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025149|NCT01180790|OG002|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11150216|NCT01876381|EG000|Reported Event|OPC-41061|Dose-titration period Administration of OPC-41061 will be started at 7.5 mg/day and the dose was increased stepwise up to as high as 60 mg/day until the dose for intermittent administration is determined. (If the dose was not fixed, the subject received the next higher dose following a 6-day washout period.) Intermittent administration period Subjects received once-daily 4-day intermittent administration of OPC-41061 (days on which hemodialysis or hemodiafiltration was not performed).
11025150|NCT01180790|OG003|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025151|NCT01180790|OG004|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025152|NCT01180790|OG005|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025153|NCT01180790|OG006|Outcome|Segment 2 : 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025154|NCT01180790|OG005|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025155|NCT01180790|OG006|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11225804|NCT02370407|EG000|Reported Event|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).~Laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
11025156|NCT01180790|EG000|Reported Event|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025157|NCT01180790|EG001|Reported Event|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
11025158|NCT01180790|EG002|Reported Event|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025159|NCT01180790|EG003|Reported Event|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025160|NCT01180790|EG004|Reported Event|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025161|NCT01180790|EG005|Reported Event|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025162|NCT01180790|EG006|Reported Event|Segment 1 - Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
11025163|NCT01180894|BG000|Baseline|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
11025164|NCT01180894|BG001|Baseline|Placebo|"Placebo~100 mg Normal saline"
11025165|NCT01180894|BG002|Baseline|Total|Total of all reporting groups
11025166|NCT01180894|FG000|Participant Flow|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
11025167|NCT01180894|FG001|Participant Flow|Placebo|Placebo (100 mg normal saline)
11025168|NCT01180894|OG000|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
11025169|NCT01180894|OG001|Outcome|Placebo|"Pacebo - Normal Saline~Placebo"
11025170|NCT01180894|OG001|Outcome|Placebo|"Placebo~100 mg Normal saline"
11025171|NCT01180894|OG001|Outcome|Placebo|Placebo (100 mg normal saline)
11225805|NCT02370407|EG001|Reported Event|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).~Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
11025172|NCT01180894|EG000|Reported Event|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
11025173|NCT01180894|EG001|Reported Event|Placebo|"Placebo~100 mg Normal saline"
11025174|NCT01180985|BG000|Baseline|All Subjects|All enrolled subjects at baseline.
11025175|NCT01180985|FG000|Participant Flow|Galyfilcon A (Test)/Comfilcon A (Control)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
11025176|NCT01180985|FG001|Participant Flow|Comfilcon A (Control)/Galyfilcon A (Test)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
11025177|NCT01180985|OG000|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
11025178|NCT01180985|OG001|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
11025179|NCT01180985|OG000|Outcome|Comfilcon A Lens (Control)|All subjects who wore comfilcon A lenses
11025180|NCT01180985|OG001|Outcome|Galyfilcon A Lens (Test)|All subjects who wore galyfilcon A lenses
11025181|NCT01180985|EG000|Reported Event|Galyfilcon A Prototype/Comfilcon A|All enrolled subjects were to wear both lenses through the course of the study.
11025182|NCT01180998|BG000|Baseline|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
11025183|NCT01180998|BG001|Baseline|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
11025184|NCT01180998|BG002|Baseline|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
11025185|NCT01180998|BG003|Baseline|Total|Total of all reporting groups
11025186|NCT01180998|FG000|Participant Flow|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
11025187|NCT01180998|FG001|Participant Flow|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
11025188|NCT01180998|FG002|Participant Flow|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
11025189|NCT01180998|OG000|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
11025190|NCT01180998|OG001|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
11025191|NCT01180998|OG002|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
11025192|NCT01180998|OG001|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
11025193|NCT01180998|EG000|Reported Event|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users will use one of two toric lenses in a daily wear modality.
11025194|NCT01180998|EG001|Reported Event|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, will use one of two toric lenses in a daily wear modality.
11025195|NCT01180998|EG002|Reported Event|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses will use one of two toric lenses in a daily wear modality.
11025196|NCT01181011|BG000|Baseline|All Participants|all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
11025197|NCT01181011|FG000|Participant Flow|All Participants|
11025198|NCT01181011|OG000|Outcome|Telmisartan 80mg, Amlodipine 5mg|
11025199|NCT01181011|OG001|Outcome|Telmisartan 80mg|
11025200|NCT01181011|OG001|Outcome|Amlodipine 5mg|
11025201|NCT01181011|OG002|Outcome|Amlodipine 5mg|
11025202|NCT01181011|EG000|Reported Event|Telmisartan 80mg, Amlodipine 5mg|
11025203|NCT01181011|EG001|Reported Event|Telmisartan 80mg|
11025204|NCT01181011|EG002|Reported Event|Amlodipine 5mg|
11025205|NCT01181050|BG000|Baseline|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
11025206|NCT01181050|BG001|Baseline|Placebo|Subjects received a single dose of placebo
11025207|NCT01181050|BG002|Baseline|Total|Total of all reporting groups
11025208|NCT01181050|FG000|Participant Flow|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
11025209|NCT01181050|FG001|Participant Flow|Placebo|Subjects received a single dose of placebo
11025210|NCT01181050|OG000|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
11025211|NCT01181050|OG001|Outcome|Placebo|Subjects received a single dose of placebo
11025212|NCT01181050|EG000|Reported Event|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
11025213|NCT01181050|EG001|Reported Event|Placebo|Subjects received a single dose of placebo
11025214|NCT01181076|BG000|Baseline|Individualized Nutrition|Individualized Nutrition: The patients who are able to achieve oral nutrition requirement will receive a therapeutic diet using regular foods, which is lactose-reduced and energy-enriched. The naso-jejunal tube will be inserted during the first five days after transplantation. EN will be given when oral intake discontinue. EN with an additional PN will be given if the estimated requirements by the enteral route is lower than reference values.
11025215|NCT01181076|BG001|Baseline|Control Group|The patients in the control group will be nourished after established routine, first by the oral route, later by the PN route. Naso-jejunal tube will not be inserted and enteral nutrition will not be given.
11025216|NCT01181076|BG002|Baseline|Total|Total of all reporting groups
11025217|NCT01181076|FG000|Participant Flow|Individualized Nutrition|Individualized Nutrition: The patients who are able to achieve oral nutrition requirement will receive a therapeutic diet using regular foods, which is lactose-reduced and energy-enriched. The naso-jejunal tube will be inserted during the first five days after transplantation. EN will be given when oral intake discontinue. EN with an additional PN will be given if the estimated requirements by the enteral route is lower than reference values.
11025218|NCT01181076|FG001|Participant Flow|Control Group|The patients in the control group will be nourished after established routine, first by the oral route, later by the PN route. Naso-jejunal tube will not be inserted and enteral nutrition will not be given.
11025219|NCT01181076|OG000|Outcome|Individualized Nutrition|Individualized Nutrition: The patients who are able to achieve oral nutrition requirement will receive a therapeutic diet using regular foods, which is lactose-reduced and energy-enriched. The naso-jejunal tube will be inserted during the first five days after transplantation. EN will be given when oral intake discontinue. EN with an additional PN will be given if the estimated requirements by the enteral route is lower than reference values.
11025220|NCT01181076|OG001|Outcome|Control Group|The patients in the control group will be nourished after established routine, first by the oral route, later by the PN route. Naso-jejunal tube will not be inserted and enteral nutrition will not be given.
11025221|NCT01181076|EG000|Reported Event|Individualized Nutrition|Individualized Nutrition: The patients who are able to achieve oral nutrition requirement will receive a therapeutic diet using regular foods, which is lactose-reduced and energy-enriched. The naso-jejunal tube will be inserted during the first five days after transplantation. EN will be given when oral intake discontinue. EN with an additional PN will be given if the estimated requirements by the enteral route is lower than reference values.
11025222|NCT01181076|EG001|Reported Event|Control Group|The patients in the control group will be nourished after established routine, first by the oral route, later by the PN route. Naso-jejunal tube will not be inserted and enteral nutrition will not be given.
11025223|NCT01181102|BG000|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
11025224|NCT01181102|BG001|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
11025225|NCT01181102|BG002|Baseline|Total|Total of all reporting groups
11025226|NCT01181102|FG000|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
11025227|NCT01181102|FG001|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
11025228|NCT01181102|OG000|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
11025229|NCT01181102|OG001|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
11025230|NCT01181102|EG000|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
11025231|NCT01181102|EG001|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
11025232|NCT01181128|BG000|Baseline|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
11025233|NCT01181128|BG001|Baseline|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
11025234|NCT01181128|BG002|Baseline|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
11025235|NCT01181128|BG003|Baseline|Total|Total of all reporting groups
11025236|NCT01181128|FG000|Participant Flow|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
11025237|NCT01181128|FG001|Participant Flow|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
11025238|NCT01181128|FG002|Participant Flow|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
11025239|NCT01181128|OG000|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
11025240|NCT01181128|OG001|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
11025241|NCT01181128|OG002|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
11025242|NCT01181128|OG003|Outcome|All Arms: Total|All participants from the Individualized (Tailored) Prophylaxis, Weekly Prophylaxis, and Episodic (On-Demand) Dosing arms.
11025243|NCT01181128|OG000|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, Advate|"Participants underwent pharmacokinetic (PK) analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) and then a single dose of 50 IU/kg rFVIIIFc (rFVIIIFc Day 0) within 8 weeks of the Advate dose. A >= 96 hour washout from Advate or any other FVIII product was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via IV injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
11025244|NCT01181128|OG001|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, rFVIIIFc Only|"On rFVIIIFc Day 0, participants underwent pharmacokinetic (PK) analysis with a single dose of 50 IU/kg rFVIIIFc in order to estimate their PK parameters and guide the appropriate dose or interval of dosing.~After the PK assessment, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by PK analyses, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
11025245|NCT01181128|OG002|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
11025246|NCT01181128|OG003|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
11025247|NCT01181128|OG004|Outcome|Any Arm: Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
11025248|NCT01181128|OG001|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
11150217|NCT01876420|BG000|Baseline|The CoreValve™ Evolut R TAV™ System|"CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 & 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System~The CoreValve™ Evolut R TAV™ system: CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 & 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System"
11150218|NCT01876420|FG000|Participant Flow|All Implanted Subjects|Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
11025249|NCT01181128|OG000|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
11025250|NCT01181128|OG000|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
11025251|NCT01181128|OG000|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
11025252|NCT01181128|OG001|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
11025253|NCT01181128|OG000|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
11025254|NCT01181128|EG000|Reported Event|Individualized (Tailored) Prophylaxis, rFVIIIFc|"Initial twice weekly dosing with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days to maintain a trough level of 1% to 3% (or higher, as clinically indicated) rFVIIIFc activity.~Prior to rFVIIIFc treatment, on rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with rFVIIIFc in order to estimate participant's PK parameters and guide the appropriate dose or interval of dosing. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~A subset of participants (Sequential PK Subgroup) also had PK profiling performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout from Advate or any other FVIII product was performed before the first PK dose of rFVIIIFc was administered."
11025255|NCT01181128|EG001|Reported Event|Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
11025256|NCT01181128|EG002|Reported Event|Episodic (On-Demand) Dosing|Initial single dose of 50 IU/kg of rFVIIIFc via IV injection followed by 10 to 50 IU/kg rFVIIIFc, as required to treat a bleeding episode
11025257|NCT01181141|BG000|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
11025258|NCT01181141|BG001|Baseline|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
10849762|NCT00298090|FG000|Participant Flow|StO2 Values Pre and Post Arterial Line Placement|single arm study of StO2 in subjects undergoing placement of arterial line. Measurements of StO2 will be taken before and after arterial line placement.
11025259|NCT01181141|BG002|Baseline|Total|Total of all reporting groups
11025260|NCT01181141|FG000|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
11025261|NCT01181141|FG001|Participant Flow|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
11025262|NCT01181141|OG000|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
11025263|NCT01181141|OG001|Outcome|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
11025264|NCT01181141|EG000|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
11025265|NCT01181141|EG001|Reported Event|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
11025266|NCT01181167|BG000|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
11025267|NCT01181167|BG001|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
11025268|NCT01181167|BG002|Baseline|Total|Total of all reporting groups
11025269|NCT01181167|FG000|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
11025270|NCT01181167|FG001|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
11025271|NCT01181167|OG000|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
10849763|NCT00298090|OG000|Outcome|StO2 Values|StO2 pre and post catheter placement
11025272|NCT01181167|OG001|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
11025273|NCT01181167|EG000|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
11025274|NCT01181167|EG001|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
11025275|NCT01181258|BG000|Baseline|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
11025276|NCT01181258|FG000|Participant Flow|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
11025277|NCT01181258|OG000|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
11025278|NCT01181258|EG000|Reported Event|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
11025279|NCT01181271|BG000|Baseline|Autologous Then Allogeneic Transplant|Autologous then allogeneic stem cell transplantation
11025280|NCT01181271|FG000|Participant Flow|Autologous Then Allogeneic Transplant|Autologous, then Allogeneic Stem Cell Transplantation
11025281|NCT01181271|OG000|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
11025282|NCT01181271|EG000|Reported Event|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
11025283|NCT01181323|BG000|Baseline|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
11150219|NCT01876420|OG000|Outcome|All Implanted Subjects|Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
10849764|NCT00298090|EG000|Reported Event|StO2|StO2 measurements pre and post arterial line catheter placement.
10849765|NCT00298155|BG000|Baseline|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
10849766|NCT00298155|BG001|Baseline|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
11025284|NCT01181323|BG001|Baseline|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
11025285|NCT01181323|BG002|Baseline|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
11025286|NCT01181323|BG003|Baseline|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
11025287|NCT01181323|BG004|Baseline|Total|Total of all reporting groups
11025288|NCT01181323|FG000|Participant Flow|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection
11025289|NCT01181323|FG001|Participant Flow|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
11025290|NCT01181323|FG002|Participant Flow|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
11025291|NCT01181323|FG003|Participant Flow|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
11025292|NCT01181323|OG000|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
11025293|NCT01181323|OG001|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
11025294|NCT01181323|OG002|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
11025295|NCT01181323|OG003|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
11025296|NCT01181323|OG000|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
11025297|NCT01181323|OG001|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
11025298|NCT01181323|OG000|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
11025299|NCT01181323|OG001|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
11025300|NCT01181323|OG002|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
11025301|NCT01181323|OG003|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
11025302|NCT01181323|OG000|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
11025303|NCT01181323|OG001|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
11025304|NCT01181323|OG002|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
11025305|NCT01181323|OG003|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
11025306|NCT01181323|OG000|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
11025307|NCT01181323|OG002|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
11025308|NCT01181323|EG000|Reported Event|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
11025309|NCT01181323|EG001|Reported Event|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
11025310|NCT01181323|EG002|Reported Event|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
11025311|NCT01181323|EG003|Reported Event|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
11025312|NCT01181349|BG000|Baseline|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
11025313|NCT01181349|FG000|Participant Flow|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
11025314|NCT01181349|OG000|Outcome|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
11025315|NCT01181349|OG000|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
11025316|NCT01181349|OG001|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
11025317|NCT01181349|EG000|Reported Event|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
11025318|NCT01181479|BG000|Baseline|AG200-15|Intervention is drug: AG200-15 containing ethinyl estradiol and levonorgestrel for cycles 1-13.
11025319|NCT01181479|BG001|Baseline|Lessina Crossover to AG200-15|Intervention with drug: Lessina containing 20 mcg ethinyl estradiol and 100 mcg levonorgestrel in 21 day regimen cycles 1-6 followed by AG200-15 for cycles 7-13.
11025320|NCT01181479|BG002|Baseline|Total|Total of all reporting groups
11025321|NCT01181479|FG000|Participant Flow|AG200-15 (Cycles 1-13)|Intervention with drug: AG200-15 containing ethinyl estradiol and levonorgestrel. Administered for cycles 1-13.
11025322|NCT01181479|FG001|Participant Flow|Lessina (Cycles 1-6)|The Lessina regimen was taken for Cycles 1-6.
11025323|NCT01181479|FG002|Participant Flow|Lessina (Cycles 1-6) Crossover to AG200-15 (Cycles 7-13)|Intervention with drug: Lessina containing 20 mcg ethinyl estradiol and 100 mcg levonorgestrel in 21 day regimen cycles 1-6 followed by AG200-15 for cycles 7-13.
11025324|NCT01181479|OG000|Outcome|AG200-15 for Cycle 7-13|Subjects that applied AG200-15 for cycles 7-13.
11025325|NCT01181479|OG001|Outcome|Lessina|Subjects that only received Lessina for cycles 1-6.
11025326|NCT01181479|OG002|Outcome|AG200-15 for Cycle 1-13|Subjects that applied AG200-15 for all cycles (1-13)
11025327|NCT01181479|OG000|Outcome|AG200-15 for Cycle 1-6|Subjects that applied AG200-15 for cycles 1-6.
11025328|NCT01181479|OG000|Outcome|Lessina Cycles 1-6|Subjects that only received Lessina for cycles 1-6.
11025329|NCT01181479|OG001|Outcome|AG200-15 for Cycle 1-13|Subjects that applied AG200-15 for cycles 1-13.
11025330|NCT01181479|OG002|Outcome|AG200-15 for Cycles 7-13|Subjects switched hormonal contraceptive from Lessina to AG200-15 for cycle 7-13.
11025331|NCT01181479|OG000|Outcome|All Subjects Who Applied AG200-15|Intervention with drug: AG200-15 containing ethinyl estradiol and levonorgestrel
11025332|NCT01181479|EG000|Reported Event|All AG200-15|All subjects that received AG200-15, including subjects that switched from Lessina to AG200-15 for cycles 7-13.
11025333|NCT01181479|EG001|Reported Event|Lessina|Subjects that only received Lessina for cycles 1-6.
11025334|NCT01181492|BG000|Baseline|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
11025335|NCT01181492|BG001|Baseline|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
11025336|NCT01181492|BG002|Baseline|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
11025337|NCT01181492|BG003|Baseline|Total|Total of all reporting groups
10886749|NCT00496015|BG000|Baseline|Synflorix I Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
11025338|NCT01181492|FG000|Participant Flow|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
11025339|NCT01181492|FG001|Participant Flow|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
11025340|NCT01181492|FG002|Participant Flow|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
11025341|NCT01181492|OG000|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
11025342|NCT01181492|OG001|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
11025343|NCT01181492|OG002|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
11025344|NCT01181492|EG000|Reported Event|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
11025345|NCT01181492|EG001|Reported Event|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
11025346|NCT01181492|EG002|Reported Event|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
11025347|NCT01181531|BG000|Baseline|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
11025348|NCT01181531|BG001|Baseline|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
11025349|NCT01181531|BG002|Baseline|Total|Total of all reporting groups
11025350|NCT01181531|FG000|Participant Flow|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
11025351|NCT01181531|FG001|Participant Flow|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
11025352|NCT01181531|OG000|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
11025353|NCT01181531|OG001|Outcome|Cinacalcet|Cinacalcet Hydrochloride
11025354|NCT01181531|EG000|Reported Event|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
11025355|NCT01181531|EG001|Reported Event|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
11025356|NCT01181596|BG000|Baseline|Ultrasound Probing|Ultrasound probing to guide catheter placement
11025357|NCT01181596|FG000|Participant Flow|Ultrasound Probing|Ultrasound probing to guide catheter placement
11025358|NCT01181596|OG000|Outcome|Arm 1: Observational Ultrasound|Collection of image data with the ultrasound probe.
11025359|NCT01181596|OG000|Outcome|Ultrasound Probing|Ultrasound probing to guide catheter placement
11025360|NCT01181596|EG000|Reported Event|Ultrasound Probing|Ultrasound probing to guide catheter placement
11025361|NCT01181609|BG000|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
11150220|NCT01876420|EG000|Reported Event|All Attempted Implanted Subjects|Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
11025362|NCT01181609|FG000|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
11025363|NCT01181609|OG000|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
11025364|NCT01181609|EG000|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
11025365|NCT01181674|BG000|Baseline|Group 1 (Short)|"insulin glargine: sc injection~metformin: oral administration~acarbose: oral administration~lifestyle therapy: diet and exercise"
11025366|NCT01181674|BG001|Baseline|Group 2 (Long)|"insulin glargine: sc injection~metformin: oral administration~acarbose: oral administration~lifestyle therapy: diet and exercise"
11025367|NCT01181674|BG002|Baseline|Standard Care|Standard glycemic care: as informed by the current clinical practice guidelines
11025368|NCT01181674|BG003|Baseline|Total|Total of all reporting groups
11025369|NCT01181674|FG000|Participant Flow|Group 1 (Short)|"insulin glargine: sc injection~metformin: oral administration~acarbose: oral administration~lifestyle therapy: diet and exercise"
11025370|NCT01181674|FG001|Participant Flow|Group 2 (Long)|"insulin glargine: sc injection~metformin: oral administration~acarbose: oral administration~lifestyle therapy: diet and exercise"
11025371|NCT01181674|FG002|Participant Flow|Standard Care|Standard glycemic care: as informed by the current clinical practice guidelines
11025372|NCT01181674|OG000|Outcome|Group 1 (Short)|"insulin glargine: sc injection~metformin: oral administration~acarbose: oral administration~lifestyle therapy: diet and exercise"
11025373|NCT01181674|OG001|Outcome|Group 2 (Long)|"insulin glargine: sc injection~metformin: oral administration~acarbose: oral administration~lifestyle therapy: diet and exercise"
11025374|NCT01181674|OG002|Outcome|Standard Care|Standard glycemic care: as informed by the current clinical practice guidelines
11025375|NCT01181674|EG000|Reported Event|Group 1 (Short)|"insulin glargine: sc injection~metformin: oral administration~acarbose: oral administration~lifestyle therapy: diet and exercise"
11025376|NCT01181674|EG001|Reported Event|Group 2 (Long)|"insulin glargine: sc injection~metformin: oral administration~acarbose: oral administration~lifestyle therapy: diet and exercise"
11025377|NCT01181674|EG002|Reported Event|Standard Care|Standard glycemic care: as informed by the current clinical practice guidelines
11025378|NCT01181726|BG000|Baseline|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
11025379|NCT01181726|BG001|Baseline|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
11025380|NCT01181726|BG002|Baseline|Total|Total of all reporting groups
11025381|NCT01181726|FG000|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
11025382|NCT01181726|FG001|Participant Flow|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
11025383|NCT01181726|OG000|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
11025384|NCT01181726|OG001|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
11025385|NCT01181726|EG000|Reported Event|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
11025386|NCT01181726|EG001|Reported Event|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
11025387|NCT01181804|BG000|Baseline|Boceprevir Tablets Then Capsules (Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
11025388|NCT01181804|BG001|Baseline|Boceprevir Capsules Then Tablets (Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
11025389|NCT01181804|BG002|Baseline|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
11025390|NCT01181804|BG003|Baseline|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
11025391|NCT01181804|BG004|Baseline|Total|Total of all reporting groups
11025392|NCT01181804|FG000|Participant Flow|Boceprevir Tablets Then Capsules ( Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
11025393|NCT01181804|FG001|Participant Flow|Boceprevir Capsules Then Tablets ( Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
11025394|NCT01181804|FG002|Participant Flow|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
11025395|NCT01181804|FG003|Participant Flow|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
11225806|NCT02370420|BG000|Baseline|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
11225807|NCT02370420|BG001|Baseline|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
11225808|NCT02370420|BG002|Baseline|Total|Total of all reporting groups
11225809|NCT02370420|FG000|Participant Flow|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
11225810|NCT02370420|FG001|Participant Flow|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
11225811|NCT02370420|OG000|Outcome|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
11225812|NCT02370420|OG001|Outcome|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
11225813|NCT02370420|EG000|Reported Event|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
11225814|NCT02370420|EG001|Reported Event|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
11225815|NCT02370498|BG000|Baseline|Pembrolizumab|Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
10886750|NCT00496015|BG001|Baseline|Synflorix II Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
11225816|NCT02370498|BG001|Baseline|Paclitaxel|Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
11225817|NCT02370498|BG002|Baseline|Total|Total of all reporting groups
11225818|NCT02370498|FG000|Participant Flow|Pembrolizumab|Participants receive 200 mg intravenous (IV) pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
11225819|NCT02370498|FG001|Participant Flow|Paclitaxel|Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
11225820|NCT02370498|OG000|Outcome|Pembrolizumab|Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
10886751|NCT00496015|BG002|Baseline|Synflorix PRE Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
11025396|NCT01181804|OG000|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
11025397|NCT01181804|OG001|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
11025398|NCT01181804|OG000|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
11025399|NCT01181804|OG001|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
11025400|NCT01181804|EG000|Reported Event|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
11025401|NCT01181804|EG001|Reported Event|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
11025402|NCT01181804|EG002|Reported Event|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
11025403|NCT01181804|EG003|Reported Event|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
11025404|NCT01181895|BG000|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
11025405|NCT01181895|BG001|Baseline|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11025406|NCT01181895|BG002|Baseline|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11025407|NCT01181895|BG003|Baseline|Total|Total of all reporting groups
11025408|NCT01181895|FG000|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
11025409|NCT01181895|FG001|Participant Flow|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11025410|NCT01181895|FG002|Participant Flow|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11025411|NCT01181895|OG000|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
11025412|NCT01181895|OG001|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11025413|NCT01181895|OG002|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10886752|NCT00496015|BG003|Baseline|Synflorix POST Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
11025414|NCT01181895|EG000|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
11025415|NCT01181895|EG001|Reported Event|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11025416|NCT01181895|EG002|Reported Event|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11025417|NCT01181947|BG000|Baseline|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection>~> TEVAR: Thoracic endovascular aneurysm repair"
11025418|NCT01181947|FG000|Participant Flow|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection>~> TEVAR: Thoracic endovascular aneurysm repair"
11025419|NCT01181947|OG000|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection~TEVAR: Thoracic endovascular aneurysm repair"
11025420|NCT01181947|OG000|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
11025421|NCT01181947|EG000|Reported Event|1. VCOUS|Medtronic VCOUS
11150221|NCT01876446|BG000|Baseline|A: Chemo Resistant|"Group A: chemo resistant - those progressing on first-line therapy < 3 months after completion of treatment.~Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies"
11025422|NCT01181986|BG000|Baseline|Sub-study 1: Exenatide SC|Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study
11025423|NCT01181986|BG001|Baseline|Sub-study 2: Exenatide IV|Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study
11025424|NCT01181986|BG002|Baseline|Total|Total of all reporting groups
11025425|NCT01181986|FG000|Participant Flow|Exenatide Then Placebo (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
11025426|NCT01181986|FG001|Participant Flow|Placebo Then Exenatide (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
11025427|NCT01181986|FG002|Participant Flow|Exenatide IV (Sub-study 2)|Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo
11025428|NCT01181986|OG000|Outcome|Exenatide (Subs-study 1)|Exenatide: Exenatide 5-10 ug sc BID/10 days
11025429|NCT01181986|OG001|Outcome|Placebo (Sub-study 1)|Placebo sc BID for 10 days
11025430|NCT01181986|OG002|Outcome|Saline+Exenatide (Sub-study 2)|Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
11025431|NCT01181986|OG003|Outcome|Saline+Placebo (Sub-study 2)|Infusion of saline (min 0-75), added placebo infusion (min 30-75)
11025432|NCT01181986|OG004|Outcome|Exendin-9+Exenatide (Sub-study 2)|Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
11025433|NCT01181986|OG000|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
11025434|NCT01181986|OG001|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
11025435|NCT01181986|EG000|Reported Event|Exenatide SC (Sub-study 1)|Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11
11025436|NCT01181986|EG001|Reported Event|Placebo SC (Sub-study 1)|Placebo sc BID/10days, AM dose and meal test on day 11
11025437|NCT01181986|EG002|Reported Event|Saline+Exenatide IV (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)
11025438|NCT01181986|EG003|Reported Event|Saline+Placebo (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)
11025439|NCT01181986|EG004|Reported Event|Exendin-9+Exenatide IV (Sub-study 2)|Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)
11025440|NCT01182103|BG000|Baseline|Major Depressive Patients|
11025441|NCT01182103|BG001|Baseline|Healthy Subjects|
11025442|NCT01182103|BG002|Baseline|Total|Total of all reporting groups
11025443|NCT01182103|FG000|Participant Flow|Major Depressive Patients|
11025444|NCT01182103|FG001|Participant Flow|Healthy Subjects|
11025445|NCT01182103|OG000|Outcome|Major Depressive Patients|
11025446|NCT01182103|OG001|Outcome|Healthy Subjects|
11025447|NCT01182103|OG000|Outcome|Healthy Subjects|
11025448|NCT01182103|OG001|Outcome|Major Depressive Patients Before Treatment|
11025449|NCT01182103|OG002|Outcome|Major Depressive Patients After Treatment|
11025450|NCT01182103|EG000|Reported Event|Major Depressive Patients|
11025451|NCT01182103|EG001|Reported Event|Healthy Subjects|
11025452|NCT01182181|BG000|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
11025453|NCT01182181|BG001|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
11025454|NCT01182181|BG002|Baseline|Total|Total of all reporting groups
11025455|NCT01182181|FG000|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
11025456|NCT01182181|FG001|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
11025457|NCT01182181|OG000|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
11025458|NCT01182181|OG001|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
11025459|NCT01182181|EG000|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
11025460|NCT01182181|EG001|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
11025461|NCT01182194|BG000|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
11025462|NCT01182194|BG001|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
11025463|NCT01182194|BG002|Baseline|Total|Total of all reporting groups
11025464|NCT01182194|FG000|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
11025465|NCT01182194|FG001|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
11025466|NCT01182194|OG000|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
11025467|NCT01182194|OG001|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
11025468|NCT01182194|EG000|Reported Event|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
11225821|NCT02370498|OG001|Outcome|Paclitaxel|Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
11025469|NCT01182194|EG001|Reported Event|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
11025470|NCT01182207|BG000|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
11025471|NCT01182207|BG001|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
11025472|NCT01182207|BG002|Baseline|Total|Total of all reporting groups
11025473|NCT01182207|FG000|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
11025474|NCT01182207|FG001|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
11025475|NCT01182207|OG000|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
11025476|NCT01182207|OG001|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
11025477|NCT01182207|EG000|Reported Event|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
11025478|NCT01182207|EG001|Reported Event|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
11025479|NCT01182285|BG000|Baseline|All Participants (Phase 1 and Phase 2 Schedule 2)|"A- Phase 1 Radioiodine-Resistant Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening~B2 - Phase 2 Schedule 2 Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks."
11025480|NCT01182285|FG000|Participant Flow|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
11025481|NCT01182285|FG001|Participant Flow|B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 17 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Drug: Cytomel (25 micrograms) Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Liothyronine Sodium (Cytomel) for 4 weeks (25 micrograms twice a day)
11025482|NCT01182285|FG002|Participant Flow|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
11025483|NCT01182285|OG000|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
11025484|NCT01182285|OG001|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
11025485|NCT01182285|OG000|Outcome|All Participants|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
11025486|NCT01182285|OG000|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radiiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
11025487|NCT01182285|EG000|Reported Event|All Participants (Phase 1 and Phase 2 Schedule 2)|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
11025488|NCT01182298|BG000|Baseline|Standard|HCV INFECTED LATINO ARTICIPANTS
11025489|NCT01182298|FG000|Participant Flow|PegIFN and Ribavirin|"Latino Patients with hepatitis C receiving weekly pegIFN and ribavirin.~This is an observational study. The observed treatment is received and managed through their primary care."
11025490|NCT01182298|OG000|Outcome|Hepatitis C|latino participants with Hepatitis C
11025491|NCT01182298|EG000|Reported Event|Standard|Patients receiving weekly peg interferon and ribavirin for hCV treatment were studied This is an observational study. The observed treatment is received and managed through their primary care.
11025492|NCT01182337|BG000|Baseline|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11025493|NCT01182337|BG001|Baseline|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
11025494|NCT01182337|BG002|Baseline|Total|Total of all reporting groups
11025495|NCT01182337|FG000|Participant Flow|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11025496|NCT01182337|FG001|Participant Flow|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
11025497|NCT01182337|OG000|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11225822|NCT02370498|EG000|Reported Event|Pembrolizumab First Course|Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
11225823|NCT02370498|EG001|Reported Event|Paclitaxel|Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
11025498|NCT01182337|OG001|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
11025499|NCT01182337|OG000|Outcome|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11025500|NCT01182337|EG000|Reported Event|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
11025501|NCT01182337|EG001|Reported Event|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
11025502|NCT01182350|BG000|Baseline|All Biopsied Participants|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O^6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive)."
11025503|NCT01182350|FG000|Participant Flow|Cohort 1: MGMT-/EGFR-|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles"
11025504|NCT01182350|FG001|Participant Flow|Cohort 2: MGMT-/EGFR+|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles"
11225824|NCT02370498|EG002|Reported Event|Pembrolizumab Second Course|Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
11025505|NCT01182350|FG002|Participant Flow|Cohort 3 MGMT+/EGFR-|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles"
11025506|NCT01182350|FG003|Participant Flow|Cohort 4. MGMT+/EGFR+|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles~Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles"
11025507|NCT01182350|FG004|Participant Flow|Ineligible for Direct Treatment Assignment|All enrolled participants were to receive surgical biopsy to guide treatment assignment based on molecular results.Participants without an evaluable sample were ineligible for direct treatment assignment.
11025508|NCT01182350|OG000|Outcome|All Patients Starting Assigned Chemoradiation|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O^6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive)."
11025509|NCT01182350|OG000|Outcome|All Biopsied Participants|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive)."
11025510|NCT01182350|OG000|Outcome|Cohort 1 MGMT-/EGFR-|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles"
11025511|NCT01182350|OG001|Outcome|Cohort 2 MGMT-/EGFR+|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles"
11025512|NCT01182350|OG002|Outcome|Cohort 3: MGMT+/EGFR-|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles"
11025513|NCT01182350|OG003|Outcome|Cohort 4. MGMT+/EGFR+|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles"
11025514|NCT01182350|OG000|Outcome|Cohort 1: MGMT-/EGFR-|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy~Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles"
11225825|NCT02370511|BG000|Baseline|Native Mitral Valve With Severe MAC|"Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
10886753|NCT00496015|BG004|Baseline|Mencevax + Infanrix Hexa Group|Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
10886754|NCT00496015|BG005|Baseline|Total|Total of all reporting groups
11148787|NCT01867086|FG000|Participant Flow|Vigil™ Vaccine|"Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.~Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)"
11148788|NCT01867086|OG000|Outcome|Vigil™ Vaccine|"Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.~Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)"
11148789|NCT01867086|EG000|Reported Event|Vigil™ Vaccine|Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
11148790|NCT01867164|BG000|Baseline|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
11148791|NCT01867164|BG001|Baseline|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
11148792|NCT01867164|BG002|Baseline|Total|Total of all reporting groups
11148793|NCT01867164|FG000|Participant Flow|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
11148794|NCT01867164|FG001|Participant Flow|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter (mcg/ml) nystatin was administered vaginally, every 24 hours at night, for 10 days.
11148795|NCT01867164|OG000|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
11148796|NCT01867164|OG001|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
11148797|NCT01867164|EG000|Reported Event|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
11148798|NCT01867164|EG001|Reported Event|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
11148799|NCT01867216|BG000|Baseline|Placebo QD or BID|Placebo administered orally QD or BID for up to 28 days.
11148800|NCT01867216|BG001|Baseline|60 mg LY2922470 QD|60 mg LY2922470 administered orally QD for up to 28 days.
11148801|NCT01867216|BG002|Baseline|200 mg LY2922470 QD|200 mg LY2922470 administered orally QD for up to 28 days.
11148802|NCT01867216|BG003|Baseline|500 mg LY2922470 QD|500 mg LY2922470 administered orally QD for up to 28 days.
11148803|NCT01867216|BG004|Baseline|1200 mg LY2922470 QD|1200 mg LY2922470 administered orally QD for up to 28 days.
11148804|NCT01867216|BG005|Baseline|150 mg LY2922470 BID|150 mg LY2922470 administered orally BID for up to 28 days.
11148805|NCT01867216|BG006|Baseline|400 mg LY2922470 BID|400 mg LY2922470 administered orally BID for up to 28 days.
11148806|NCT01867216|BG007|Baseline|Total|Total of all reporting groups
11148807|NCT01867216|FG000|Participant Flow|Placebo QD or BID|Placebo administered orally once daily (QD) or twice daily (BID) for up to 28 days.
11148808|NCT01867216|FG001|Participant Flow|60 mg LY2922470 QD|60 mg LY2922470 administered orally QD for up to 28 days.
11148809|NCT01867216|FG002|Participant Flow|200 mg LY2922470 QD|200 mg LY2922470 administered orally QD for up to 28 days.
11148810|NCT01867216|FG003|Participant Flow|500 mg LY2922470 QD|500 mg LY2922470 administered orally QD for up to 28 days.
11148811|NCT01867216|FG004|Participant Flow|1200 mg LY2922470 QD|1200 mg LY2922470 administered orally QD for up to 28 days.
11148812|NCT01867216|FG005|Participant Flow|150 mg LY2922470 BID|150 mg LY2922470 administered orally BID for up to 28 days.
11148813|NCT01867216|FG006|Participant Flow|400 mg LY2922470 BID|400 mg LY2922470 administered orally BID for up to 28 days.
11148814|NCT01867216|OG000|Outcome|Placebo QD or BID|Placebo administered orally QD or BID for up to 28 days.
11148815|NCT01867216|OG001|Outcome|60 mg LY2922470 QD|60 mg LY2922470 administered orally QD for up to 28 days.
11148816|NCT01867216|OG002|Outcome|200 mg LY2922470 QD|200 mg LY2922470 administered orally QD for up to 28 days.
11148817|NCT01867216|OG003|Outcome|500 mg LY2922470 QD|500 mg LY2922470 administered orally QD for up to 28 days.
11148818|NCT01867216|OG004|Outcome|1200 mg LY2922470 QD|1200 mg LY2922470 administered orally QD for up to 28 days.
11148819|NCT01867216|OG005|Outcome|150 mg LY2922470 BID|150 mg LY2922470 administered orally BID for up to 28 days.
11148820|NCT01867216|OG006|Outcome|400 mg LY2922470 BID|400 mg LY2922470 administered orally BID for up to 28 days.
11148821|NCT01867216|OG000|Outcome|60 mg LY2922470 QD|60 mg LY2922470 administered orally QD for up to 28 days.
11148822|NCT01867216|OG001|Outcome|200 mg LY2922470 QD|200 mg LY2922470 administered orally QD for up to 28 days.
11148823|NCT01867216|OG002|Outcome|500 mg LY2922470 QD|500 mg LY2922470 administered orally QD for up to 28 days.
11148824|NCT01867216|OG003|Outcome|1200 mg LY2922470 QD|1200 mg LY2922470 administered orally QD for up to 28 days.
11148825|NCT01867216|OG004|Outcome|150 mg LY2922470 BID|150 mg LY2922470 administered orally BID for up to 28 days.
11148826|NCT01867216|OG005|Outcome|400 mg LY2922470 BID|400 mg LY2922470 administered orally BID for up to 28 days.
11148827|NCT01867216|EG000|Reported Event|Placebo QD or BID|Placebo administered orally QD or BID for up to 28 days.
11025515|NCT01182350|OG001|Outcome|Cohort 2: MGMT-/EGFR+|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy~Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles~Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles"
11025516|NCT01182350|OG002|Outcome|Cohort 3. MGMT+/EGFR-|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy~Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles~Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles"
11025517|NCT01182350|OG003|Outcome|Cohort 4. MGMT+/EGFR+|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy~Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles~Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles"
11025518|NCT01182350|EG000|Reported Event|Cohort 1 MGMT-/EGFR-|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles"
11148828|NCT01867216|EG001|Reported Event|60 mg LY2922470 QD|60 mg LY2922470 administered orally QD for up to 28 days.
11148829|NCT01867216|EG002|Reported Event|200 mg LY2922470 QD|200 mg LY2922470 administered orally QD for up to 28 days.
11148830|NCT01867216|EG003|Reported Event|500 mg LY2922470 QD|500 mg LY2922470 administered orally QD for up to 28 days.
11148831|NCT01867216|EG004|Reported Event|1200 mg LY2922470 QD|1200 mg LY2922470 administered orally QD for up to 28 days.
11148832|NCT01867216|EG005|Reported Event|150 mg LY2922470 BID|150 mg LY2922470 administered orally BID for up to 28 days.
11148833|NCT01867216|EG006|Reported Event|400 mg LY2922470 BID|400 mg LY2922470 administered orally BID for up to 28 days.
11148834|NCT01867294|BG000|Baseline|Study I: Spironolactone|Patients apply spironolactone topically to face BID for 4 weeks.
11148835|NCT01867294|BG001|Baseline|Study I: Placebo|Patients apply placebo topically to face BID for 4 weeks.
11148836|NCT01867294|BG002|Baseline|Study II: Spironolactone|Patients apply spironolactone topically to face and body BID for 4 weeks.
11148837|NCT01867294|BG003|Baseline|Study II: Modified Therapy|Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
11148838|NCT01867294|BG004|Baseline|Total|Total of all reporting groups
11148839|NCT01867294|FG000|Participant Flow|Study I: Spironolactone|Patients apply spironolactone topically to face BID for 4 weeks.
11148840|NCT01867294|FG001|Participant Flow|Study I: Placebo|Patients apply placebo topically to face BID for 4 weeks.
11148841|NCT01867294|FG002|Participant Flow|Study II: Spironolactone|Patients apply spironolactone topically to face and body BID for 4 weeks.
11148842|NCT01867294|FG003|Participant Flow|Study II: Modified Therapy|Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
11148843|NCT01867294|OG000|Outcome|Study I: Spironolactone|Patients apply spironolactone topically to face BID for 4 weeks.
11148844|NCT01867294|OG001|Outcome|Study I: Placebo|Patients apply placebo topically to face BID for 4 weeks.
11148845|NCT01867294|OG002|Outcome|Study II: Spironolactone|Patients apply spironolactone topically to face and body BID for 4 weeks.
11148846|NCT01867294|OG003|Outcome|Study II: Modified Therapy|Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
11148847|NCT01867294|EG000|Reported Event|Study I: Placebo|Patients apply placebo topically to face BID for 4 weeks.
11148848|NCT01867294|EG001|Reported Event|Study I: Spironolactone|.Patients apply spironolactone topically to face BID for 4 weeks.
11148849|NCT01867307|BG000|Baseline|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
11148850|NCT01867307|BG001|Baseline|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
11148851|NCT01867307|BG002|Baseline|Total|Total of all reporting groups
11025519|NCT01182350|EG001|Reported Event|Cohort 2 MGMT-/EGFR+|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles"
11025520|NCT01182350|EG002|Reported Event|Cohort 3: MGMT+/EGFR-|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles"
11025521|NCT01182350|EG003|Reported Event|Cohort 4. MGMT+/EGFR+|"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).~Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles"
11025522|NCT01182376|BG000|Baseline|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
11025523|NCT01182376|BG001|Baseline|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
11025524|NCT01182376|BG002|Baseline|Total|Total of all reporting groups
11025525|NCT01182376|FG000|Participant Flow|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
11025526|NCT01182376|FG001|Participant Flow|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
11025527|NCT01182376|OG000|Outcome|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
11025528|NCT01182376|OG001|Outcome|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
11025529|NCT01182376|EG000|Reported Event|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
11025530|NCT01182376|EG001|Reported Event|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
11025531|NCT01182415|BG000|Baseline|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
11025532|NCT01182415|FG000|Participant Flow|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
11025533|NCT01182415|OG000|Outcome|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
11025534|NCT01182415|EG000|Reported Event|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
11025535|NCT01182428|BG000|Baseline|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
11025536|NCT01182428|BG001|Baseline|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
11025537|NCT01182428|BG002|Baseline|Total|Total of all reporting groups
11025538|NCT01182428|FG000|Participant Flow|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
11025539|NCT01182428|FG001|Participant Flow|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
11025540|NCT01182428|OG000|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
11025541|NCT01182428|OG001|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
11025542|NCT01182428|EG000|Reported Event|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
11025543|NCT01182428|EG001|Reported Event|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
11025544|NCT01182441|BG000|Baseline|WATCHMAN|"Subjects assigned to receive the WATCHMAN device.~WATCHMAN Device: WATCHMAN Left Atrial Appendage Closure Technology"
11025545|NCT01182441|BG001|Baseline|Warfarin|"Subjects assigned to warfarin therapy.~Warfarin: Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0"
11025546|NCT01182441|BG002|Baseline|Total|Total of all reporting groups
11025547|NCT01182441|FG000|Participant Flow|WATCHMAN|"Subjects assigned to receive the WATCHMAN device.~WATCHMAN Device: WATCHMAN Left Atrial Appendage Closure Technology"
11025548|NCT01182441|FG001|Participant Flow|Warfarin|"Subjects assigned to warfarin therapy.~Warfarin: Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0"
11025549|NCT01182441|OG000|Outcome|WATCHMAN|"Subjects assigned to receive the WATCHMAN device.~WATCHMAN Device: WATCHMAN Left Atrial Appendage Closure Technology"
11025550|NCT01182441|OG001|Outcome|Warfarin|"Subjects assigned to warfarin therapy.~Warfarin: Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0"
11025551|NCT01182441|EG000|Reported Event|WATCHMAN|"Subjects assigned to receive the WATCHMAN device.~WATCHMAN Device: WATCHMAN Left Atrial Appendage Closure Technology"
11025552|NCT01182441|EG001|Reported Event|Warfarin|"Subjects assigned to warfarin therapy.~Warfarin: Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0"
11025553|NCT01182480|BG000|Baseline|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
11025554|NCT01182480|FG000|Participant Flow|Text Intervention|Group of study participants who received the text message intervention over a 3-month period. Participants received text messages 7, 2, and 1 day(s) prior to each of their scheduled appointments as recorded in the Denver Health scheduling system, and also received text messages prompts 3 times per week asking them to provide fasting blood sugar readings.
11025555|NCT01182480|OG000|Outcome|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
11025556|NCT01182480|EG000|Reported Event|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
11025557|NCT01182493|BG000|Baseline|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient"
11025558|NCT01182493|BG001|Baseline|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
11025559|NCT01182493|BG002|Baseline|Total|Total of all reporting groups
11025560|NCT01182493|FG000|Participant Flow|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
11025561|NCT01182493|FG001|Participant Flow|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
11025562|NCT01182493|OG000|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
11025563|NCT01182493|OG001|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
11025564|NCT01182493|EG000|Reported Event|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
11025565|NCT01182493|EG001|Reported Event|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
11025566|NCT01182675|BG000|Baseline|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
11025567|NCT01182675|BG001|Baseline|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
11025568|NCT01182675|BG002|Baseline|Total|Total of all reporting groups
11025569|NCT01182675|FG000|Participant Flow|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
11025570|NCT01182675|FG001|Participant Flow|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
11025571|NCT01182675|OG000|Outcome|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
11025572|NCT01182675|OG001|Outcome|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
11025573|NCT01182675|OG000|Outcome|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor Intervention: Transplant Conditioning with Mobilization Only~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
11025574|NCT01182675|OG001|Outcome|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor Intervention: Transplant Conditioning with Mobilization and Alemtuzumab~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
11025575|NCT01182675|EG000|Reported Event|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
11025576|NCT01182675|EG001|Reported Event|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
11025577|NCT01182805|BG000|Baseline|Single Arm Study.|
11025578|NCT01182805|FG000|Participant Flow|All Study Participants|All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure.
11025579|NCT01182805|OG000|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
11025580|NCT01182805|OG001|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
11025581|NCT01182805|OG002|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
11025582|NCT01182805|EG000|Reported Event|Single Arm Study.|
11025583|NCT01182844|BG000|Baseline|Control|Usual care
11025584|NCT01182844|BG001|Baseline|Lactobacillus Casei Shirota|"3 bottles of Yakult(R) light per day~Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day"
11025585|NCT01182844|BG002|Baseline|Total|Total of all reporting groups
11025586|NCT01182844|FG000|Participant Flow|Control|Usual care
11025587|NCT01182844|FG001|Participant Flow|Lactobacillus Casei Shirota|"3 bottles of Yakult(R) light per day~Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day"
11025588|NCT01182844|OG000|Outcome|Control|Usual care
11025589|NCT01182844|OG001|Outcome|Lactobacillus Casei Shirota|"3 bottles of Yakult(R) light per day~Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day"
11025590|NCT01182844|EG000|Reported Event|Control|Usual care
11025591|NCT01182844|EG001|Reported Event|Lactobacillus Casei Shirota|"3 bottles of Yakult(R) light per day~Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day"
11025592|NCT01183013|BG000|Baseline|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
11025593|NCT01183013|BG001|Baseline|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
11025594|NCT01183013|BG002|Baseline|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
11025595|NCT01183013|BG003|Baseline|Lina5/Lina5|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
11025596|NCT01183013|BG004|Baseline|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by a blinded trial period on linagliptin 5mg + pioglitazone 30mg FDC
11025597|NCT01183013|BG005|Baseline|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
11025598|NCT01183013|BG006|Baseline|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
11025599|NCT01183013|BG007|Baseline|Total|Total of all reporting groups
11025600|NCT01183013|FG000|Participant Flow|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
11025601|NCT01183013|FG001|Participant Flow|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
11025602|NCT01183013|FG002|Participant Flow|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
11025603|NCT01183013|FG003|Participant Flow|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
11025604|NCT01183013|FG004|Participant Flow|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
11025605|NCT01183013|FG005|Participant Flow|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
11025606|NCT01183013|FG006|Participant Flow|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
11025607|NCT01183013|OG000|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
11025608|NCT01183013|OG001|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
11025609|NCT01183013|OG002|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
11025610|NCT01183013|OG003|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
11025611|NCT01183013|OG004|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
11025612|NCT01183013|OG005|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
11025613|NCT01183013|OG006|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
11025614|NCT01183013|OG002|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
11025615|NCT01183013|EG000|Reported Event|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
11025616|NCT01183013|EG001|Reported Event|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
11025617|NCT01183013|EG002|Reported Event|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
11025618|NCT01183013|EG003|Reported Event|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
11025619|NCT01183013|EG004|Reported Event|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
11025620|NCT01183013|EG005|Reported Event|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
11025621|NCT01183013|EG006|Reported Event|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
11025622|NCT01183065|BG000|Baseline|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
11025623|NCT01183065|FG000|Participant Flow|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
11148852|NCT01867307|FG000|Participant Flow|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
11148853|NCT01867307|FG001|Participant Flow|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
11148854|NCT01867307|OG000|Outcome|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
11025624|NCT01183065|OG000|Outcome|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
11025625|NCT01183065|EG000|Reported Event|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
11025626|NCT01183104|BG000|Baseline|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
11025627|NCT01183104|BG001|Baseline|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
11025628|NCT01183104|BG002|Baseline|Total|Total of all reporting groups
11025629|NCT01183104|FG000|Participant Flow|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
11025630|NCT01183104|FG001|Participant Flow|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
11025631|NCT01183104|OG000|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
11025632|NCT01183104|OG001|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
11025633|NCT01183104|EG000|Reported Event|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
11025634|NCT01183104|EG001|Reported Event|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
11025635|NCT01183143|BG000|Baseline|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
11025636|NCT01183143|FG000|Participant Flow|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
10886755|NCT00496015|FG000|Participant Flow|Synflorix I Group|Subjects were vaccinated with 3 primary vaccination doses of Synflorix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
11025637|NCT01183143|OG000|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
11025638|NCT01183143|EG000|Reported Event|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
11025639|NCT01183169|BG000|Baseline|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
11025640|NCT01183169|BG001|Baseline|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
11025641|NCT01183169|BG002|Baseline|Treatment C|Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
11025642|NCT01183169|BG003|Baseline|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
11025643|NCT01183169|BG004|Baseline|Total|Total of all reporting groups
11025644|NCT01183169|FG000|Participant Flow|Treatment A|Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks.
11025645|NCT01183169|FG001|Participant Flow|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
11025646|NCT01183169|FG002|Participant Flow|Treatment C1|Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) <LOQ after 12 weeks of treatment) could switch to active ALV 600 mg QD with PEG and RBV.
11025647|NCT01183169|FG003|Participant Flow|Treatment C2|Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
11025648|NCT01183169|FG004|Participant Flow|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
11025649|NCT01183169|FG005|Participant Flow|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
11025650|NCT01183169|FG006|Participant Flow|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
11025651|NCT01183169|OG000|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
11025652|NCT01183169|OG001|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
11025653|NCT01183169|OG002|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
11025654|NCT01183169|OG003|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
11025655|NCT01183169|OG004|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
11025656|NCT01183169|OG005|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
11025657|NCT01183169|EG000|Reported Event|Treatment A: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
11025658|NCT01183169|EG001|Reported Event|Treatment B: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
11025659|NCT01183169|EG002|Reported Event|Treatment C1: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
11025660|NCT01183169|EG003|Reported Event|Treatment C2: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
11025661|NCT01183169|EG004|Reported Event|Treatment D: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
11025662|NCT01183169|EG005|Reported Event|Treatment A: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
11025663|NCT01183169|EG006|Reported Event|Treatment B: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
11025664|NCT01183169|EG007|Reported Event|Treatment C1: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
11025665|NCT01183169|EG008|Reported Event|Treatment C2: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
11025666|NCT01183169|EG009|Reported Event|Treatment D: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
11025667|NCT01183234|BG000|Baseline|Equasym XL First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
11025668|NCT01183234|BG001|Baseline|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules)
11025669|NCT01183234|BG002|Baseline|Total|Total of all reporting groups
11025670|NCT01183234|FG000|Participant Flow|Equasym XL (SPD544) First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule)
11025671|NCT01183234|FG001|Participant Flow|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules)
11025672|NCT01183234|OG000|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
11025673|NCT01183234|OG001|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
11025674|NCT01183234|EG000|Reported Event|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
11025675|NCT01183234|EG001|Reported Event|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
11025676|NCT01183260|BG000|Baseline|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
11025677|NCT01183260|BG001|Baseline|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
11025678|NCT01183260|BG002|Baseline|Total|Total of all reporting groups
11025679|NCT01183260|FG000|Participant Flow|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
11025680|NCT01183260|FG001|Participant Flow|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
11025681|NCT01183260|OG000|Outcome|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
11025682|NCT01183260|OG001|Outcome|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
11025683|NCT01183260|EG000|Reported Event|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
11025684|NCT01183260|EG001|Reported Event|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
11025685|NCT01183312|BG000|Baseline|Placebo First, Then Flumazenil|Placebo during the first intervention day and sublingual flumazenil during the second intervention day (after washout period).
11025686|NCT01183312|BG001|Baseline|Flumazenil First, Then Placebo|Sublingual flumazenil during the first intervention day and placebo during the second intervention day (after washout period).
11025687|NCT01183312|BG002|Baseline|Total|Total of all reporting groups
11025688|NCT01183312|FG000|Participant Flow|Placebo First, Then Flumazenil|Placebo administered sublingually three times during the first study day, followed by a washout of at least 7 days, then flumazenil administered sublingually three times during the second study day.
11025689|NCT01183312|FG001|Participant Flow|Flumazenil First, Then Placebo|Flumazenil administered sublingually three times during the first study day (as 12 mg, then 6 mg, then 6 mg, at approximately 3 hour intervals), followed by a washout of at least 7 days, then placebo administered sublingually three times on the second study day.
11025690|NCT01183312|OG000|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
11025691|NCT01183312|OG001|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
11025692|NCT01183312|EG000|Reported Event|Placebo|
11025693|NCT01183312|EG001|Reported Event|Sublingual Flumazenil|
11025694|NCT01183390|BG000|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
11025695|NCT01183390|BG001|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
11025696|NCT01183390|BG002|Baseline|Total|Total of all reporting groups
11025697|NCT01183390|FG000|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
11025698|NCT01183390|FG001|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
11025699|NCT01183390|OG000|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
11025700|NCT01183390|OG001|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
11025701|NCT01183390|EG000|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period
11025702|NCT01183390|EG001|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
11025703|NCT01183481|BG000|Baseline|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
11025704|NCT01183481|FG000|Participant Flow|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
11025705|NCT01183481|OG000|Outcome|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
11025706|NCT01183481|OG000|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
11025707|NCT01183481|EG000|Reported Event|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
11025708|NCT01183533|BG000|Baseline|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
11025709|NCT01183533|FG000|Participant Flow|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
11025710|NCT01183533|OG000|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
11025711|NCT01183533|EG000|Reported Event|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
11025712|NCT01183546|BG000|Baseline|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
11025713|NCT01183546|FG000|Participant Flow|Wheelchair Users With Spinal Cord Injury|wheelchair users with spinal cord injury
11025714|NCT01183546|OG000|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
11025715|NCT01183546|OG001|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
11025716|NCT01183546|EG000|Reported Event|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
11025717|NCT01183559|BG000|Baseline|Vandetanib|All patients were treated with vandetanib with dose escalation from 100 mg (dose level 1) to 200 mg (dose level 2) orally daily for the duration of radiation therapy
11025718|NCT01183559|FG000|Participant Flow|Vandetanib|All patients were treated with vandetanib with dose escalation from 100 mg (dose level 1) to 200 mg (dose level 2) orally daily for the duration of radiation therapy
11148855|NCT01867307|OG001|Outcome|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
11148856|NCT01867307|EG000|Reported Event|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
11148857|NCT01867307|EG001|Reported Event|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
11025719|NCT01183559|OG000|Outcome|Vandetanib|All patients were treated with Vandetanib 100 mg QD (6 patients) or 200 mg daily (3 patients) orally daily during the conventional 3D-guided conformal radiation therapy plus chemotherapy with carboplatin (AUC 5) on days 1 and 29, paclitaxel 50 mg/m2 i.v. weekly on days 1, 8, 15, 22, 29; and continuous infusion of 5-fluorouracil at 225 mg/m2 for 96 hours Monday-Friday during the radiation.
11025720|NCT01183559|OG000|Outcome|Vandetanib|All patients were treated with Vandetanib 100 mg QD (6 patients) or 200 mg QD (3 patients) orally daily during the conventional 3D-guided conformal radiation therapy plus chemotherapy with carboplatin (AUC 5) on days 1 and 29, paclitaxel 50 mg/m2 i.v. weekly on days 1, 8, 15, 22, 29; and continuous infusion of 5-fluorouracil at 225 mg/m2 for 96 hours Monday-Friday during the radiation.
11025721|NCT01183559|EG000|Reported Event|Vandetanib|All patients were treated with vandetanib with dose escalation from 100 mg (dose level 1) to 200 mg (dose level 2) orally daily for the duration of radiation therapy
11025722|NCT01183650|BG000|Baseline|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
11025723|NCT01183650|BG001|Baseline|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
11025724|NCT01183650|BG002|Baseline|Total|Total of all reporting groups
11025725|NCT01183650|FG000|Participant Flow|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
11025726|NCT01183650|FG001|Participant Flow|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
11025727|NCT01183650|OG000|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
11025728|NCT01183650|OG001|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
11025729|NCT01183650|EG000|Reported Event|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
11025730|NCT01183650|EG001|Reported Event|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
11025731|NCT01183689|BG000|Baseline|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
11025732|NCT01183689|BG001|Baseline|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
11025733|NCT01183689|BG002|Baseline|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
11025734|NCT01183689|BG003|Baseline|Total|Total of all reporting groups
11025735|NCT01183689|FG000|Participant Flow|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
11025736|NCT01183689|FG001|Participant Flow|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
11025737|NCT01183689|FG002|Participant Flow|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
11025738|NCT01183689|OG000|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
11025739|NCT01183689|OG001|Outcome|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
11025740|NCT01183689|OG002|Outcome|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
11025741|NCT01183689|OG001|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
11025742|NCT01183689|OG002|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
11025743|NCT01183689|EG000|Reported Event|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
11025744|NCT01183689|EG001|Reported Event|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
11025745|NCT01183689|EG002|Reported Event|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
11025746|NCT01183728|BG000|Baseline|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
11025747|NCT01183728|FG000|Participant Flow|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
11025748|NCT01183728|OG000|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
11225826|NCT02370511|BG001|Baseline|Valve-in-Ring|"Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11225827|NCT02370511|BG002|Baseline|Valve-in-Valve|"Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11025749|NCT01183728|EG000|Reported Event|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
11025750|NCT01183780|BG000|Baseline|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
11025751|NCT01183780|BG001|Baseline|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
11025752|NCT01183780|BG002|Baseline|Total|Total of all reporting groups
11025753|NCT01183780|FG000|Participant Flow|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
11025754|NCT01183780|FG001|Participant Flow|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
11025755|NCT01183780|OG000|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
11025756|NCT01183780|OG001|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
11025757|NCT01183780|EG000|Reported Event|FOLFIRI + Ramucirumab|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
11025758|NCT01183780|EG001|Reported Event|FOLFIRI + Placebo|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
11025759|NCT01183858|BG000|Baseline|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
11025760|NCT01183858|BG001|Baseline|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
11025761|NCT01183858|BG002|Baseline|Total|Total of all reporting groups
11225828|NCT02370511|BG003|Baseline|Total|Total of all reporting groups
11225829|NCT02370511|FG000|Participant Flow|Native Mitral Valve With Severe MAC|"Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11225830|NCT02370511|FG001|Participant Flow|Valve-in-Ring|"Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11025762|NCT01183858|FG000|Participant Flow|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
11025763|NCT01183858|FG001|Participant Flow|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
11025764|NCT01183858|OG000|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
11025765|NCT01183858|OG001|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
11025766|NCT01183858|EG000|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
11025767|NCT01183858|EG001|Reported Event|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
11025768|NCT01183923|BG000|Baseline|All Participants|the study population will be randomized in a 1:1 ratio to first eat broccoli sprouts followed by a washout period and then eat alfalfa sprouts, or to start with alfalfa sprouts followed by a washout and then eat broccoli sprouts
11025769|NCT01183923|FG000|Participant Flow|Broccoli Sprouts, Then Alfalfa Sprouts|Broccoli Sprouts will be eaten daily in a sandwich form, followed by a 14 day washout, and then alfalfa sprouts will be eaten daily in a sandwich form.
11025770|NCT01183923|FG001|Participant Flow|Alfalfa Sprouts, Then Broccoli Sprouts|Alfalfa sprouts will be eaten daily in a sandwich form, followed by a 14 day washout, and then broccoli sprouts will be eaten daily in a sandwich form.
11025771|NCT01183923|OG000|Outcome|Broccoli Sprouts|Broccoli Sprouts: Broccoli Sprouts will be eaten daily in a sandwich form followed by a washout period, after which alfalfa sprouts will be eaten in a sandwich form.
11025772|NCT01183923|OG001|Outcome|Alfalfa Sprouts|Participants who received alfalfa sprouts
11025773|NCT01183923|EG000|Reported Event|Total Study Population|Total population, which is randomized 1:1 to broccoli sprouts, then alfalfa sprouts or alfalfa sprouts, then broccoli sprouts
11025774|NCT01183975|BG000|Baseline|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
11025775|NCT01183975|FG000|Participant Flow|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
11025776|NCT01183975|OG000|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
11025777|NCT01183975|EG000|Reported Event|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
11025778|NCT01184014|BG000|Baseline|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
11025779|NCT01184014|BG001|Baseline|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
11025780|NCT01184014|BG002|Baseline|Total|Total of all reporting groups
11025781|NCT01184014|FG000|Participant Flow|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
11025782|NCT01184014|FG001|Participant Flow|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
11025783|NCT01184014|OG000|Outcome|Experimental Group|"a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO).~NPH insulin plus Complete Insulin Orders: NPH dosed per study-specific algorithm which incorporates total daily dosage of steroid to determine NPH dose. Complete insulin orders include background, meal-time and correction factor."
11025784|NCT01184014|OG001|Outcome|Control Group|"the standard recommended care (Methodist Hospital Complete Insulin Orders)~Complete Insulin Orders: 3-part insulin which includes background, meal-time and correction factor"
11025785|NCT01184014|EG000|Reported Event|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
11025786|NCT01184014|EG001|Reported Event|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
11025787|NCT01184053|BG000|Baseline|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
11025788|NCT01184053|FG000|Participant Flow|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
11025789|NCT01184053|OG000|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
11025790|NCT01184053|OG000|Outcome|Trisenox Treatment|"Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.~Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks."
11025791|NCT01184053|EG000|Reported Event|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
11025792|NCT01184079|BG000|Baseline|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
11025793|NCT01184079|BG001|Baseline|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
11025794|NCT01184079|BG002|Baseline|Total|Total of all reporting groups
11025795|NCT01184079|FG000|Participant Flow|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
11025796|NCT01184079|FG001|Participant Flow|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
11025797|NCT01184079|OG000|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
11025798|NCT01184079|OG001|Outcome|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
11025799|NCT01184079|OG000|Outcome|Group With Administration of 3rd Dose at 12 Months|"Group with administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
11025800|NCT01184079|OG001|Outcome|Group With Administration of 3rd Dose at 6 Months|"Group with administration of 3rd dose at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
11025801|NCT01184079|EG000|Reported Event|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
11025802|NCT01184079|EG001|Reported Event|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
11025803|NCT01184118|BG000|Baseline|FP 220 mcg 2 Puffs BID|"The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.~FP 220 mcg 2 puffs BID: The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care."
11025804|NCT01184118|FG000|Participant Flow|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by 2 weeks of FP 220 mcg 2 puffs BID then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks.
11025805|NCT01184118|OG000|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
11025806|NCT01184118|EG000|Reported Event|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
11025807|NCT01184326|BG000|Baseline|Dose Level 0: Everolimus 5mg + Pazopanib 600 mg|Everolimus 5mg + Pazopanib 600 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025808|NCT01184326|BG001|Baseline|Dose Level -1: Everolimus 5mg + Pazopanib 400 mg|Everolimus 5mg + Pazopanib 400 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025809|NCT01184326|BG002|Baseline|All Phase I Dose Expansion Participants|All phase I dose expansion participants received Everolimus 5mg and Pazopanib at the maximum tolerated dose established in the dose finding part of the study.
11025810|NCT01184326|BG003|Baseline|Total|Total of all reporting groups
11025811|NCT01184326|FG000|Participant Flow|Dose Level 0: Everolimus 5mg + Pazopanib 600 mg|Everolimus 5mg + Pazopanib 600 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025812|NCT01184326|FG001|Participant Flow|Dose Level -1: Everolimus 5mg + Pazopanib 400 mg|Everolimus 5mg + Pazopanib 400 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025813|NCT01184326|FG002|Participant Flow|All Phase I Dose Expansion Participants|All phase I dose expansion participants received Everolimus 5mg and Pazopanib at the maximum tolerated dose established in the dose finding part of the study.
11025814|NCT01184326|OG000|Outcome|All Phase I Dose Finding Participants|All phase I dose finding participants received Everolimus 5mg and Pazopanib according to the established dose escalation schedule.
11025815|NCT01184326|OG000|Outcome|Dose Level 0: Everolimus 5mg + Pazopanib 600 mg|Everolimus 5mg + Pazopanib 600 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025816|NCT01184326|OG001|Outcome|Dose Level -1: Everolimus 5mg + Pazopanib 400 mg|Everolimus 5mg + Pazopanib 400 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025817|NCT01184326|OG000|Outcome|All Phase I Dose Expansion Participants|All phase I dose expansion participants received Everolimus 5mg and Pazopanib at the maximum tolerated dose established in the dose finding part of the study.
11025818|NCT01184326|OG000|Outcome|Dose Level 0: Everolimus 5mg + Pazopanib 600 mg [Dose Finding]|Everolimus 5mg + Pazopanib 600 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025819|NCT01184326|OG001|Outcome|Dose Level -1: Everolimus 5mg + Pazopanib 400 mg [Dose Finding|Everolimus 5mg + Pazopanib 400 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025820|NCT01184326|EG000|Reported Event|Dose Level 0: Everolimus 5mg + Pazopanib 600 mg|Everolimus 5mg + Pazopanib 600 mg once daily for 28 days each cycle Participants were treated until disease progression, unacceptable toxicity or patient withdrawal.
11025821|NCT01184326|EG001|Reported Event|Dose Level -1: Everolimus 5mg + Pazopanib 400 mg|All phase I dose expansion participants received Everolimus 5mg and Pazopanib at the maximum tolerated dose established in the dose finding part of the study.
11025822|NCT01184326|EG002|Reported Event|All Phase I Dose Expansion Participants|All phase I dose expansion participants received Everolimus 5mg and Pazopanib at the maximum tolerated dose established in the dose finding part of the study.
11025823|NCT01184417|BG000|Baseline|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
11025824|NCT01184417|BG001|Baseline|Placebo Group|100 ml saline
11025825|NCT01184417|BG002|Baseline|Total|Total of all reporting groups
11025826|NCT01184417|FG000|Participant Flow|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
11025827|NCT01184417|FG001|Participant Flow|Placebo Group|100 ml saline
11025828|NCT01184417|OG000|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
11025829|NCT01184417|OG001|Outcome|Placebo Group|100 ml saline
11025830|NCT01184417|EG000|Reported Event|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
11025831|NCT01184417|EG001|Reported Event|Placebo Group|100 ml saline
11025832|NCT01184508|BG000|Baseline|Placebo|Capsules administered orally, once daily, for 12 weeks.
11025833|NCT01184508|BG001|Baseline|LY2300559|300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
11025834|NCT01184508|BG002|Baseline|Total|Total of all reporting groups
11025835|NCT01184508|FG000|Participant Flow|Placebo|Capsules administered orally, once daily, for 12 weeks.
11025836|NCT01184508|FG001|Participant Flow|LY2300559|300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
11025837|NCT01184508|OG000|Outcome|Placebo|Capsules administered orally, once daily, for 12 weeks.
11025838|NCT01184508|OG001|Outcome|LY2300559|300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
11025839|NCT01184508|OG000|Outcome|LY2300559|300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
11025840|NCT01184508|EG000|Reported Event|Placebo|Capsules administered orally, once daily, for 12 weeks.
11025841|NCT01184508|EG001|Reported Event|LY2300559|300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
11025842|NCT01184755|BG000|Baseline|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
11025843|NCT01184755|BG001|Baseline|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
11225831|NCT02370511|FG002|Participant Flow|Valve-in-Valve|"Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11025844|NCT01184755|BG002|Baseline|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
11025845|NCT01184755|BG003|Baseline|Total|Total of all reporting groups
11025846|NCT01184755|FG000|Participant Flow|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
11025847|NCT01184755|FG001|Participant Flow|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
11025848|NCT01184755|FG002|Participant Flow|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
11025849|NCT01184755|OG000|Outcome|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
11025850|NCT01184755|OG001|Outcome|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
11025851|NCT01184755|OG002|Outcome|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
11025852|NCT01184755|EG000|Reported Event|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
11025853|NCT01184755|EG001|Reported Event|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
11025854|NCT01184755|EG002|Reported Event|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
11025855|NCT01184846|BG000|Baseline|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
11025856|NCT01184846|FG000|Participant Flow|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
11025857|NCT01184846|OG000|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
11025858|NCT01184846|OG000|Outcome|IgPro10 - Before Infusion|IgG levels were determined before infusion with IgPro10.
11025859|NCT01184846|OG001|Outcome|IgPro10 - After Infusion|IgG levels were determined after infusion with IgPro10.
11025860|NCT01184846|EG000|Reported Event|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
11025861|NCT01184859|BG000|Baseline|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
11025862|NCT01184859|BG001|Baseline|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
11025863|NCT01184859|BG002|Baseline|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
11025864|NCT01184859|BG003|Baseline|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
11025865|NCT01184859|BG004|Baseline|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
11025866|NCT01184859|BG005|Baseline|Total|Total of all reporting groups
11025867|NCT01184859|FG000|Participant Flow|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
11025868|NCT01184859|FG001|Participant Flow|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
11025869|NCT01184859|FG002|Participant Flow|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
11025870|NCT01184859|FG003|Participant Flow|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
11025871|NCT01184859|FG004|Participant Flow|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
11025872|NCT01184859|OG000|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
11025873|NCT01184859|OG001|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
11025874|NCT01184859|OG002|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
11025875|NCT01184859|OG003|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
11025876|NCT01184859|OG004|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
11025877|NCT01184859|EG000|Reported Event|Placebo-Period 1|Study period 1: single dose of placebo.
11025878|NCT01184859|EG001|Reported Event|Desmopressin 10µg - Period 1|Study period 1: single dose of desmopressin 10µg.
11025879|NCT01184859|EG002|Reported Event|Desmopressin 25µg - Period 1|Study period 1: single dose of desmopressin 25µg.
11025880|NCT01184859|EG003|Reported Event|Desmopressin 50µg - Period 1|Study period 1: single dose of desmopressin 50µg.
11025881|NCT01184859|EG004|Reported Event|Desmopressin 100µg - Period 1|Study period 1: single dose of desmopressin 100µg.
11025882|NCT01184859|EG005|Reported Event|Placebo - Period 2|Study period 2: daily doses of placebo taken before bedtime for 28 days.
11025883|NCT01184859|EG006|Reported Event|Desmopressin 10µg - Period 2|Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
11025884|NCT01184859|EG007|Reported Event|Desmopressin 25µg - Period 2|Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
11025885|NCT01184859|EG008|Reported Event|Desmopressin 50µg - Period 2|Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
11025886|NCT01184859|EG009|Reported Event|Desmopressin 100µg - Period 2|Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
11025887|NCT01184872|BG000|Baseline|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
11025888|NCT01184872|BG001|Baseline|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
11025889|NCT01184872|BG002|Baseline|Total|Total of all reporting groups
11025890|NCT01184872|FG000|Participant Flow|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
11025891|NCT01184872|FG001|Participant Flow|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
11025892|NCT01184872|OG000|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
11025893|NCT01184872|OG001|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
11025894|NCT01184872|EG000|Reported Event|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
11025895|NCT01184872|EG001|Reported Event|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
11025896|NCT01184885|BG000|Baseline|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
11025897|NCT01184885|FG000|Participant Flow|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
11025898|NCT01184885|OG000|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m^2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m^2 on day 6; Decadron 40mg/day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m^2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m^2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m^2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
11025899|NCT01184885|OG000|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
11025900|NCT01184885|EG000|Reported Event|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
11025901|NCT01184898|BG000|Baseline|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
11025902|NCT01184898|FG000|Participant Flow|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
11025903|NCT01184898|OG000|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
11025904|NCT01184898|EG000|Reported Event|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
11025905|NCT01184989|BG000|Baseline|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
11025906|NCT01184989|FG000|Participant Flow|Patients Treated With Dabigatran Etexilate|"Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.~142 patients were enrolled for the study, but only 112 were treated. Therefore, the number of started patients corresponds to the ones that were actually treated."
11025907|NCT01184989|OG000|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
11025908|NCT01184989|EG000|Reported Event|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
11025909|NCT01185028|BG000|Baseline|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
11025910|NCT01185028|FG000|Participant Flow|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
11025911|NCT01185028|OG000|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
11025912|NCT01185028|EG000|Reported Event|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
11025913|NCT01185080|BG000|Baseline|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
11025914|NCT01185080|BG001|Baseline|Placebo|Placebo three times weekly
11025915|NCT01185080|BG002|Baseline|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
11025916|NCT01185080|BG003|Baseline|Total|Total of all reporting groups
11025917|NCT01185080|FG000|Participant Flow|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
11025918|NCT01185080|FG001|Participant Flow|Placebo|Placebo three times weekly
11025919|NCT01185080|FG002|Participant Flow|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
11025920|NCT01185080|OG000|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
11025921|NCT01185080|OG001|Outcome|Placebo|Placebo three times weekly
11025922|NCT01185080|OG002|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
11025923|NCT01185080|EG000|Reported Event|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
11025924|NCT01185080|EG001|Reported Event|Placebo|Placebo three times weekly
11025925|NCT01185080|EG002|Reported Event|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
11025926|NCT01185171|BG000|Baseline|ZD1839 500mg by Mouth (po) Daily|"Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.~Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy."
11025927|NCT01185171|FG000|Participant Flow|ZD1839 500mg by Mouth (po) Daily|"Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.~Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy."
11025928|NCT01185171|OG000|Outcome|ZD1839 500mg by Mouth (po) Daily|"Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.~Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy."
11025929|NCT01185171|EG000|Reported Event|ZD1839 500mg by Mouth (po) Daily|"Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.~Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy."
11025930|NCT01185249|BG000|Baseline|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
11025931|NCT01185249|FG000|Participant Flow|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
11025932|NCT01185249|OG000|Outcome|Evening Weights|Patients with both morning and evening weights
11025933|NCT01185249|OG001|Outcome|Morning Weight|Weight of study patients in kilograms first thing in the morning.
11025934|NCT01185249|EG000|Reported Event|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
11025935|NCT01185288|BG000|Baseline|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
11025936|NCT01185288|BG001|Baseline|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
11025937|NCT01185288|BG002|Baseline|Total|Total of all reporting groups
11025938|NCT01185288|FG000|Participant Flow|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
11025939|NCT01185288|FG001|Participant Flow|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
11148858|NCT01867424|BG000|Baseline|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
11148859|NCT01867424|BG001|Baseline|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
11148860|NCT01867424|BG002|Baseline|Total|Total of all reporting groups
11148861|NCT01867424|FG000|Participant Flow|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
11148862|NCT01867424|FG001|Participant Flow|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
11025940|NCT01185288|OG000|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
11148863|NCT01867424|OG000|Outcome|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
11148864|NCT01867424|OG001|Outcome|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
11148865|NCT01867424|EG000|Reported Event|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
11148866|NCT01867424|EG001|Reported Event|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
11148867|NCT01867515|BG000|Baseline|Younger Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 18 to 35~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
11148868|NCT01867515|BG001|Baseline|Older Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 36 to 65~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
11148869|NCT01867515|BG002|Baseline|Hearing-impaired Listeners|"individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below~age 18 to 65"
11148870|NCT01867515|BG003|Baseline|Total|Total of all reporting groups
11148871|NCT01867515|FG000|Participant Flow|Younger Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 18 to 35~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
11148872|NCT01867515|FG001|Participant Flow|Older Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 36 to 65~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
11148873|NCT01867515|FG002|Participant Flow|Hearing-impaired Listeners|"individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below~age 18 to 65"
11148874|NCT01867515|OG000|Outcome|Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 18 to 35~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
11148875|NCT01867515|OG001|Outcome|Older Normally-hearing|"Participants with auditory thresholds within the normal limits.~age 36 to 65~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
11148876|NCT01867515|OG002|Outcome|Hearing-impaired Listeners|individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below
11148877|NCT01867515|EG000|Reported Event|Younger Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 18 to 35~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
11148878|NCT01867515|EG001|Reported Event|Older Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 36 to 65~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
11148879|NCT01867515|EG002|Reported Event|Hearing-impaired Listeners|"individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below~age 18 to 65"
11148880|NCT01867580|BG000|Baseline|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
11148881|NCT01867580|BG001|Baseline|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
11148882|NCT01867580|BG002|Baseline|Total|Total of all reporting groups
11148883|NCT01867580|FG000|Participant Flow|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
11025941|NCT01185288|OG001|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
11025942|NCT01185288|EG000|Reported Event|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
11025943|NCT01185288|EG001|Reported Event|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
11025944|NCT01185301|BG000|Baseline|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
11025945|NCT01185301|BG001|Baseline|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
11025946|NCT01185301|BG002|Baseline|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
11025947|NCT01185301|BG003|Baseline|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
11025948|NCT01185301|BG004|Baseline|Total|Total of all reporting groups
11025949|NCT01185301|FG000|Participant Flow|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
11025950|NCT01185301|FG001|Participant Flow|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
11025951|NCT01185301|FG002|Participant Flow|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
11025952|NCT01185301|FG003|Participant Flow|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
11025953|NCT01185301|OG000|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
11025954|NCT01185301|OG001|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
11025955|NCT01185301|OG002|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
11025956|NCT01185301|OG003|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
11025957|NCT01185301|EG000|Reported Event|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
11025958|NCT01185301|EG001|Reported Event|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
11025959|NCT01185301|EG002|Reported Event|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
11148884|NCT01867580|FG001|Participant Flow|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
11148885|NCT01867580|OG000|Outcome|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
11148886|NCT01867580|OG001|Outcome|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
11148887|NCT01867580|EG000|Reported Event|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
11025960|NCT01185301|EG003|Reported Event|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
11025961|NCT01185340|BG000|Baseline|LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11025962|NCT01185340|BG001|Baseline|Placebo + SSRI (Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11025963|NCT01185340|BG002|Baseline|Placebo + SSRI (Non-randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11148888|NCT01867580|EG001|Reported Event|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
11148889|NCT01867632|BG000|Baseline|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
11148890|NCT01867632|BG001|Baseline|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
11148891|NCT01867632|BG002|Baseline|Total|Total of all reporting groups
11148892|NCT01867632|FG000|Participant Flow|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
11148893|NCT01867632|FG001|Participant Flow|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
11148894|NCT01867632|OG000|Outcome|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
11148895|NCT01867632|OG001|Outcome|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
11148896|NCT01867632|EG000|Reported Event|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
11148897|NCT01867632|EG001|Reported Event|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
11148898|NCT01867658|BG000|Baseline|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
11025964|NCT01185340|BG003|Baseline|Total|Total of all reporting groups
11025965|NCT01185340|FG000|Participant Flow|Placebo + SSRI (Pre-randomized Participants)|Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11025966|NCT01185340|FG001|Participant Flow|LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11025967|NCT01185340|FG002|Participant Flow|Placebo + SSRI (Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11025968|NCT01185340|FG003|Participant Flow|Placebo + SSRI (Non-randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11025969|NCT01185340|OG000|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11025970|NCT01185340|OG001|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11025971|NCT01185340|EG000|Reported Event|Placebo + SSRI (Pre-randomized) - CF Phase|"Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all enrolled participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Confirmation (CF) Phase."
11025972|NCT01185340|EG001|Reported Event|LY2216684 + SSRI (Randomized) - AT Phase|"LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11025973|NCT01185340|EG002|Reported Event|Placebo + SSRI (Randomized) - AT Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11025974|NCT01185340|EG003|Reported Event|Placebo + SSRI (Non-randomized) - AT Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all non-randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11025975|NCT01185340|EG004|Reported Event|Placebo + SSRI (Pre-randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11025976|NCT01185340|EG005|Reported Event|LY2216684 + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11025977|NCT01185340|EG006|Reported Event|Placebo + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11025978|NCT01185340|EG007|Reported Event|Placebo + SSRI (Non-randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all non-randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11025979|NCT01185353|BG000|Baseline|1 mg LY3009104|"Administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
11148899|NCT01867658|FG000|Participant Flow|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
11148900|NCT01867658|OG000|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
11148901|NCT01867658|EG000|Reported Event|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
11025980|NCT01185353|BG001|Baseline|2 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
11025981|NCT01185353|BG002|Baseline|4 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
11025982|NCT01185353|BG003|Baseline|8 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
11025983|NCT01185353|BG004|Baseline|Placebo|"Placebo administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
11025984|NCT01185353|BG005|Baseline|Total|Total of all reporting groups
11025985|NCT01185353|FG000|Participant Flow|1 Milligrams (mg) LY3009104 QD - Part A|"Administered orally once daily (QD) for 12 weeks in Part A.~Methotrexate (MTX) was administered orally as background therapy."
11025986|NCT01185353|FG001|Participant Flow|2 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
11025987|NCT01185353|FG002|Participant Flow|4 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
11025988|NCT01185353|FG003|Participant Flow|8 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
11025989|NCT01185353|FG004|Participant Flow|Placebo QD - Part A|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11025990|NCT01185353|FG005|Participant Flow|2 mg LY3009104 BID - Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 twice daily (BID) in Part B.~MTX was administered orally as background therapy."
11025991|NCT01185353|FG006|Participant Flow|4 mg LY3009104 QD - Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
11025992|NCT01185353|FG007|Participant Flow|4 mg LY3009104 QD - Parts C and D|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~Participants who completed Part C continued to receive 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11025993|NCT01185353|FG008|Participant Flow|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~At Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Participants who completed Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11025994|NCT01185353|FG009|Participant Flow|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.~Participants who completed Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11025995|NCT01185353|OG000|Outcome|4 or 8 mg LY3009104|"4 or 8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11025996|NCT01185353|OG001|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11025997|NCT01185353|OG000|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11025998|NCT01185353|OG001|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11025999|NCT01185353|OG002|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11026000|NCT01185353|OG003|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11026001|NCT01185353|OG004|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11026002|NCT01185353|OG001|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
11026003|NCT01185353|OG002|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
11026004|NCT01185353|OG003|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
11026005|NCT01185353|OG000|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11026006|NCT01185353|OG001|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11026007|NCT01185353|OG002|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11026008|NCT01185353|OG001|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11026009|NCT01185353|OG000|Outcome|1 mg LY3009104|1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
11026010|NCT01185353|OG001|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.~MTX was administered orally as background therapy."
11026011|NCT01185353|OG002|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
11026012|NCT01185353|OG003|Outcome|8 mg LY3009104|8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
11026013|NCT01185353|OG000|Outcome|1mg LY3009104|1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
11026014|NCT01185353|EG000|Reported Event|1 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11026015|NCT01185353|EG001|Reported Event|2 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11026016|NCT01185353|EG002|Reported Event|4 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Pat A.~MTX was administered orally as background therapy."
11026017|NCT01185353|EG003|Reported Event|8 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11026018|NCT01185353|EG004|Reported Event|Placebo QD - Part A|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
11026019|NCT01185353|EG005|Reported Event|2 mg LY3009104 BID Crossover- Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.~MTX was administered orally as background therapy."
11026020|NCT01185353|EG006|Reported Event|4 mg LY3009104 QD Crossover- Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
11026021|NCT01185353|EG007|Reported Event|2 mg LY3009104 QD - Part B|"Participants who received 2 mg LY3009104 QD in Part A continued to receive 2 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
11026022|NCT01185353|EG008|Reported Event|4 mg LY3009104 QD - Part B|"Participants who received 4 mg LY3009104 QD in Part A continued to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
11026023|NCT01185353|EG009|Reported Event|8 mg LY3009104 QD - Part B|"Participants who received 8 mg LY3009104 QD in Part A continued to receive 8 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
11026024|NCT01185353|EG010|Reported Event|4 mg LY3009104 QD - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~MTX was administered orally as background therapy."
11026025|NCT01185353|EG011|Reported Event|4 to 8 mg LY3009104 QD Pre-Rescue - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C.~MTX was administered orally as background therapy.~Adverse events were collected from Week 24 until predose of 8 mg LY3009104 QD."
11026026|NCT01185353|EG012|Reported Event|4 to 8 mg LY3009104 QD Post-Rescue - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C.~MTX was administered orally as background therapy.~Adverse events were collected from predose of 8 mg LY3009104 QD until Week 76."
11026027|NCT01185353|EG013|Reported Event|8 mg LY3009104 QD - Part C|"Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.~MTX was administered orally as background therapy."
11026028|NCT01185353|EG014|Reported Event|4 mg LY3009104 QD - Part D|"Participants who received 4 mg LY3009104 QD in Part C continued to receive 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11026029|NCT01185353|EG015|Reported Event|4 mg LY3009104 QD (4 to 8 mg Rescue)- Part D|"Participants who received 8 mg LY3009104 QD rescue treatment in Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11026030|NCT01185353|EG016|Reported Event|8/4 mg LY3009104 QD - Part D|"Participants who received 8 mg LY3009104 QD in Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
11026031|NCT01185353|EG017|Reported Event|Follow-Up|"Up to 28 days post the last dose of study drug.~MTX was administered orally as background therapy."
11026032|NCT01185366|BG000|Baseline|Everolimus|4 weeks of everolimus of 10 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to sunitinib.
11026033|NCT01185366|BG001|Baseline|Sunitinib|4 weeks of sunitinib of 50 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to everolimus.
11026034|NCT01185366|BG002|Baseline|Total|Total of all reporting groups
11026035|NCT01185366|FG000|Participant Flow|Everolimus|4 weeks of everolimus of 10 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to sunitinib.
11026036|NCT01185366|FG001|Participant Flow|Sunitinib|4 weeks of sunitinib of 50 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to everolimus.
11026037|NCT01185366|OG000|Outcome|Everolimus|4 weeks of everolimus of 10 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to sunitinib.
11341326|NCT03681353|EG000|Reported Event|Reduced Use Condition|"This arm includes six weeks of mobile contingency management treatment administered via a smart-phone based application (mobile CM), in which participants are provided monetary reinforcement for reducing cannabis use.~Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use."
11026038|NCT01185366|OG001|Outcome|Sunitinib|4 weeks of sunitinib of 50 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to everolimus.
11026039|NCT01185366|OG000|Outcome|Everolimus|4 weeks of everolimus of 10 mg orally each day then 2 weeks of no medication until progression.
11026040|NCT01185366|OG001|Outcome|Sunitinib|4 weeks of sunitinib of 50 mg orally each day then 2 weeks of no medication until progression.
11026041|NCT01185366|EG000|Reported Event|Everolimus|4 weeks of everolimus 10 mg orally each day then 2 weeks of no medication until progression.
11026042|NCT01185366|EG001|Reported Event|Sunitinib|4 weeks of sunitinib 50 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to everolimus.
11026043|NCT01185509|BG000|Baseline|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11026044|NCT01185509|BG001|Baseline|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11026045|NCT01185509|BG002|Baseline|Total|Total of all reporting groups
11026046|NCT01185509|FG000|Participant Flow|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11026047|NCT01185509|FG001|Participant Flow|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11148902|NCT01867671|BG000|Baseline|Peanut Oral Immune Therapy (OIT)|"Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.~Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance."
11148903|NCT01867671|BG001|Baseline|Peanut Placebo|"Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.~Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance."
11148904|NCT01867671|BG002|Baseline|Total|Total of all reporting groups
11026048|NCT01185509|OG000|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11026049|NCT01185509|OG001|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11026050|NCT01185509|OG000|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11026051|NCT01185509|EG000|Reported Event|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11148905|NCT01867671|FG000|Participant Flow|Peanut Oral Immune Therapy (OIT)|"Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.~Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance."
11148906|NCT01867671|FG001|Participant Flow|Peanut Placebo|"Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.~Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance."
11148907|NCT01867671|OG000|Outcome|Peanut Oral Immune Therapy (OIT)|"Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.~Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance."
11148908|NCT01867671|OG001|Outcome|Peanut Placebo|"Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.~Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance."
11148909|NCT01867671|EG000|Reported Event|Peanut Oral Immunotherapy (OIT)|Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.
11148910|NCT01867671|EG001|Reported Event|Peanut Placebo|Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract was derived from oat flour source material.
11148911|NCT01867710|BG000|Baseline|Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID|Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148912|NCT01867710|BG001|Baseline|Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148913|NCT01867710|BG002|Baseline|Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11026052|NCT01185509|EG001|Reported Event|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
11026053|NCT01185522|BG000|Baseline|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
11026054|NCT01185522|FG000|Participant Flow|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
11026055|NCT01185522|OG000|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
11026056|NCT01185522|OG000|Outcome|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
11026057|NCT01185522|EG000|Reported Event|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
11026058|NCT01185548|BG000|Baseline|All Participants|"Three study periods: Period 1 which was tolbutamide only and lasted 4 days and Periods 2 and 3 which had continued access to tasisulam every 28 days until disease progression:~Period 1: 500 mg tolbutamide administered once on Day 1.~Period 2: 500 mg of tolbutamide and individualized tasisulam dose administered once on Day 1.~Period 3: individualized tasisulam dose administered once on Day 1 and 500 mg tolbutamide administered once on Day 4."
11026059|NCT01185548|FG000|Participant Flow|All Participants|"Period 1: 500 milligram (mg) tolbutamide administered once on Day 1~Period 2: 500 mg of tolbutamide and individualized tasisulam dose (based on AUCalb) administered once on Day 1~Period 3: individualized tasisulam dose (based on AUCalb) administered once on Day 1 and 500 mg tolbutamide administered once on day 4"
11026060|NCT01185548|OG000|Outcome|Period 2: Tasisulam and Tolbutamide|Period 2: 500 mg of tolbutamide and individualized tasisulam dose (based on AUCalb) administered once on Day 1
11026061|NCT01185548|OG000|Outcome|Tasisulam and Tolbutamide: Period 3|Period 3: Individualized tasisulam dose (based on AUCalb) administered once on Day 1 and 500 mg tolbutamide administered once on Day 4.
11026062|NCT01185548|OG000|Outcome|Tolbutamide: Period 1|Period 1: 500 mg tolbutamide administered once on Day 1
11026063|NCT01185548|OG001|Outcome|Tasisulam and Tolbutamide: Period 2|Period 2: 500 mg of tolbutamide and individualized tasisulam dose (based on AUCalb) administered once on Day 1.
11026064|NCT01185548|OG002|Outcome|Tasisulam and Tolbutamide: Period 3|Period 3: individualized tasisulam dose (based on AUCalb) administered once on Day 1 and 500 mg tolbutamide administered once on Day 4.
11026065|NCT01185548|OG000|Outcome|Period 1: Tolbutamide|Period 1: 500 mg tolbutamide administered once on Day 1
11026066|NCT01185548|OG001|Outcome|Period 2: Tasisulam and Tolbutamide|Period 2: 500 mg tolbutamide and an individualized tasisulam dose (based on AUCalb) administered once on Day 1.
11026067|NCT01185548|OG002|Outcome|Period 3: Tasisulam and Tolbutamide|Period 3: Individualized tasisulam dose (based on AUCalb) administered once on Day 1 and 500 mg tolbutamide administered once on day 4 (administration day in period 3 could adjusted based on interim pharmacokinetic [PK] analyses)
11026068|NCT01185548|EG000|Reported Event|Tolbutamide|Adverse events (AEs) that occurred during Period 1 and during Period 2 when 500 mg tolbutamide was administered orally prior to individualized intravenous dosing (based on AUCalb) of tasisulam.
11026069|NCT01185548|EG001|Reported Event|Tasisulam and Tolbutamide|AEs that occurred during Periods 2 and 3 when both 500 mg oral tolbutamide and individualized intravenous tasisulam (based on AUCalb) were administered.
11026070|NCT01185548|EG002|Reported Event|Tasisulam|AEs that occurred during Period 3 Day 1 through Day 4 until just before 500 mg oral tolbutamide was administered on Day 4, 72 hours.
11026071|NCT01185561|BG000|Baseline|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
11026072|NCT01185561|BG001|Baseline|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
11026073|NCT01185561|BG002|Baseline|Total|Total of all reporting groups
11026074|NCT01185561|FG000|Participant Flow|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
11026075|NCT01185561|FG001|Participant Flow|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
11150222|NCT01876446|BG001|Baseline|B: Chemo Sensitive|"Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.~Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Pegylated Irinotecan: Given IV~Pharmacological Study: Correlative studies"
11026076|NCT01185561|OG000|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
11026077|NCT01185561|OG001|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
11026078|NCT01185561|EG000|Reported Event|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
11026079|NCT01185561|EG001|Reported Event|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
11026080|NCT01185600|BG000|Baseline|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
11026081|NCT01185600|BG001|Baseline|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
11026082|NCT01185600|BG002|Baseline|Total|Total of all reporting groups
11026083|NCT01185600|FG000|Participant Flow|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
11026084|NCT01185600|FG001|Participant Flow|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
11026085|NCT01185600|OG000|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
11026086|NCT01185600|OG001|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
11026087|NCT01185600|OG000|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency,or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
11026088|NCT01185600|OG000|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
11026089|NCT01185600|OG001|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
11026090|NCT01185600|EG000|Reported Event|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
11026091|NCT01185600|EG001|Reported Event|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
11026092|NCT01185639|BG000|Baseline|SBRT for Metastatic NSCLC|"SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions~stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques"
11026093|NCT01185639|FG000|Participant Flow|SBRT for Metastatic NSCLC|"SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions~stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques"
11026094|NCT01185639|OG000|Outcome|SBRT for Metastatic NSCLC|"SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions~stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques"
11150223|NCT01876446|BG002|Baseline|Total|Total of all reporting groups
11026095|NCT01185639|EG000|Reported Event|SBRT for Metastatic NSCLC|"SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions~stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques"
11026096|NCT01185704|BG000|Baseline|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
11026097|NCT01185704|BG001|Baseline|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
11026098|NCT01185704|BG002|Baseline|Total|Total of all reporting groups
11026099|NCT01185704|FG000|Participant Flow|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
11026100|NCT01185704|FG001|Participant Flow|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
11026101|NCT01185704|OG000|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
11026102|NCT01185704|OG001|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
11026103|NCT01185704|EG000|Reported Event|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
11026104|NCT01185704|EG001|Reported Event|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
11026105|NCT01185782|BG000|Baseline|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
11026106|NCT01185782|BG001|Baseline|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
11026107|NCT01185782|BG002|Baseline|Total|Total of all reporting groups
11026108|NCT01185782|FG000|Participant Flow|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
11026109|NCT01185782|FG001|Participant Flow|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
11026110|NCT01185782|OG000|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
11026111|NCT01185782|OG001|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
11026112|NCT01185782|EG000|Reported Event|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
11026113|NCT01185782|EG001|Reported Event|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
11026114|NCT01185821|BG000|Baseline|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026115|NCT01185821|BG001|Baseline|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026116|NCT01185821|BG002|Baseline|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026117|NCT01185821|BG003|Baseline|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026118|NCT01185821|BG004|Baseline|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026119|NCT01185821|BG005|Baseline|Total|Total of all reporting groups
11026120|NCT01185821|FG000|Participant Flow|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026121|NCT01185821|FG001|Participant Flow|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026122|NCT01185821|FG002|Participant Flow|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026123|NCT01185821|FG003|Participant Flow|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026124|NCT01185821|FG004|Participant Flow|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026125|NCT01185821|OG000|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026126|NCT01185821|OG001|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026127|NCT01185821|OG002|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026128|NCT01185821|OG003|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026129|NCT01185821|OG004|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026130|NCT01185821|OG000|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
11026131|NCT01185821|EG000|Reported Event|BAF312 10/2 mg|BAF312 10/2 mg
11026132|NCT01185821|EG001|Reported Event|BAF312 2/2 mg|BAF312 2/2 mg
11026133|NCT01185821|EG002|Reported Event|BAF312 1.25/2 mg|BAF312 1.25/2 mg
11026134|NCT01185821|EG003|Reported Event|BAF312 0.5/2 mg|BAF312 0.5/2 mg
11026135|NCT01185821|EG004|Reported Event|BAF312 0.25/2 mg|BAF312 0.25/2 mg
11026136|NCT01185821|EG005|Reported Event|All Patients|All patients
11026137|NCT01185834|BG000|Baseline|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
11026138|NCT01185834|FG000|Participant Flow|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
11026139|NCT01185834|OG000|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
11026140|NCT01185834|EG000|Reported Event|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
11026141|NCT01185964|BG000|Baseline|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
11026142|NCT01185964|BG001|Baseline|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
11026143|NCT01185964|BG002|Baseline|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
11026144|NCT01185964|BG003|Baseline|Total|Total of all reporting groups
11026145|NCT01185964|FG000|Participant Flow|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
11026146|NCT01185964|FG001|Participant Flow|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
11026147|NCT01185964|FG002|Participant Flow|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
11026148|NCT01185964|FG003|Participant Flow|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
11026149|NCT01185964|OG000|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle~Doxorubicin 75 mg/m2 by IV on day 1 of the 21-day cycle."
11026150|NCT01185964|OG001|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
11026151|NCT01185964|OG000|Outcome|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle~Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle."
11026152|NCT01185964|OG000|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle."
11026153|NCT01185964|OG002|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
11026154|NCT01185964|OG000|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
11026155|NCT01185964|OG000|Outcome|Phase 1b and Phase 2 Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
11026156|NCT01185964|OG000|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
11026157|NCT01185964|OG000|Outcome|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
11026158|NCT01185964|OG001|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
11026159|NCT01185964|EG000|Reported Event|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
11026160|NCT01185964|EG001|Reported Event|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
11026161|NCT01185964|EG002|Reported Event|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
11026162|NCT01185964|EG003|Reported Event|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
10886756|NCT00496015|FG001|Participant Flow|Synflorix II Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
11026163|NCT01186250|BG000|Baseline|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
11026164|NCT01186250|BG001|Baseline|Placebo|"Placebo~Placebo: placebo taken daily for one year"
11026165|NCT01186250|BG002|Baseline|Total|Total of all reporting groups
11026166|NCT01186250|FG000|Participant Flow|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
11026167|NCT01186250|FG001|Participant Flow|Placebo|"Placebo~Placebo: placebo taken daily for one year"
11026168|NCT01186250|OG000|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
11026169|NCT01186250|OG001|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
11026170|NCT01186250|EG000|Reported Event|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
11026171|NCT01186250|EG001|Reported Event|Placebo|"Placebo~Placebo: placebo taken daily for one year"
11026172|NCT01186328|BG000|Baseline|EZN Dose Level 1|Dose Level 1 is the starting dose level. Patients will receive 2 doses of EZN-3042 at 2.5 mg/m2/day (and intrathecal cytarabine, conditionally) prior to initiating systemic therapy with vincristine, doxorubicin, prednisone and PEG-asparaginase, and then Day 8, 15, 22, and 29. If MTD is exceeded at dose level 1, the dose level will be deescalated to Dose Level 0.
11026173|NCT01186328|FG000|Participant Flow|EZN Dose Level 1|Dose Level 1 is the starting dose level. Patients will receive 2 doses of EZN-3042 at 2.5 mg/m2/day (and intrathecal cytarabine, conditionally) prior to initiating systemic therapy with vincristine, doxorubicin, prednisone and PEG-asparaginase, and then Day 8, 15, 22, and 29. If MTD is exceeded at dose level 1, the dose level will be deescalated to Dose Level 0.
11026174|NCT01186328|FG001|Participant Flow|EZN Dose Level 2|If the MTD is not exceeded at dose level 1, the dose will be escalated to dose level 2 at 5mg/m2/day. Dose will be administered following the same dosing schedule as Dose level 1.
11026175|NCT01186328|FG002|Participant Flow|EZN Dose Level 3|If the MTD is not exceeded at Dose Level 2, the dose will be escalated to Dose Level 3 at 6.5 mg/kg following the same dosing schedule as Dose Level 1 and 2.
11026176|NCT01186328|OG000|Outcome|EZN Dose Level 1|Dose Level 1 is the starting dose level. Patients will receive 2 doses of EZN-3042 at 2.5 mg/m2/day (and intrathecal cytarabine, conditionally) prior to initiating systemic therapy with vincristine, doxorubicin, prednisone and PEG-asparaginase, and then Day 8, 15, 22, and 29. If MTD is exceeded at dose level 1, the dose level will be deescalated to Dose Level 0.
11026177|NCT01186328|OG001|Outcome|EZN Dose Level 0|Study deescalated to Dose Level 0 at 1.5 mg/kg after 2 patients at Dose Level 1 experienced DLTs.
11026178|NCT01186328|EG000|Reported Event|EZN Dose Level 1|Dose Level 1 is the starting dose level. Patients will receive 2 doses of EZN-3042 at 2.5 mg/m2/day (and intrathecal cytarabine, conditionally) prior to initiating systemic therapy with vincristine, doxorubicin, prednisone and PEG-asparaginase, and then Day 8, 15, 22, and 29. If MTD is exceeded at dose level 1, the dose level will be deescalated to Dose Level 0.
11026179|NCT01186406|BG000|Baseline|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
11026180|NCT01186406|FG000|Participant Flow|Gliadel, Radiation Therapy, Avastin, Temodar|"Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation~Gliadel, Radiation Therapy, Avastin, Temodar: Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, they will be treated with standard radiation therapy, and daily Temodar (75mg/m2) for 6.5 weeks of radiation. In addition, Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.~Beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with Avastin (10 mg/kg) every 14 days along with 5 day Temodar (200 mg/ m2)."
11026181|NCT01186406|OG000|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
11026182|NCT01186406|EG000|Reported Event|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
11026183|NCT01186419|BG000|Baseline|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
11026184|NCT01186419|BG001|Baseline|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
11026185|NCT01186419|BG002|Baseline|Total|Total of all reporting groups
11026186|NCT01186419|FG000|Participant Flow|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
11026187|NCT01186419|FG001|Participant Flow|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
11026188|NCT01186419|OG000|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
11026189|NCT01186419|EG000|Reported Event|SPD602 16 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
11026190|NCT01186419|EG001|Reported Event|SPD602 32 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
11026191|NCT01186458|BG000|Baseline|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
11026192|NCT01186458|FG000|Participant Flow|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
11026193|NCT01186458|OG000|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
11026194|NCT01186458|EG000|Reported Event|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
11026195|NCT01186562|BG000|Baseline|Sitagliptin|Sitagliptin: 100 mg PO daily
11026196|NCT01186562|BG001|Baseline|Placebo|Placebo: Placebo
11026197|NCT01186562|BG002|Baseline|Total|Total of all reporting groups
11026198|NCT01186562|FG000|Participant Flow|Sitagliptin|Sitagliptin: 100 mg PO daily
11026199|NCT01186562|FG001|Participant Flow|Placebo|Placebo: Placebo
11026200|NCT01186562|OG000|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
11026201|NCT01186562|OG001|Outcome|Placebo|Placebo: Placebo
11026202|NCT01186562|EG000|Reported Event|Sitagliptin|Sitagliptin: 100 mg PO daily
11026203|NCT01186562|EG001|Reported Event|Placebo|Placebo: Placebo
11026204|NCT01186692|BG000|Baseline|Enrolled Cohort|All subjects enrolled.
11026205|NCT01186692|FG000|Participant Flow|Enrolled|All subjects enrolled (n=131)
11026206|NCT01186692|OG000|Outcome|Implanted >24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
11026207|NCT01186692|OG000|Outcome|Attempted Implant Cohort|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
11026208|NCT01186692|OG000|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
11026209|NCT01186692|OG000|Outcome|Implanted Cohort|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
11026210|NCT01186692|OG000|Outcome|Implanted > 24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
11026211|NCT01186692|EG000|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
11026212|NCT01186705|BG000|Baseline|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
11026213|NCT01186705|FG000|Participant Flow|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
11026214|NCT01186705|OG000|Outcome|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
11026215|NCT01186705|EG000|Reported Event|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
11026216|NCT01186744|BG000|Baseline|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
11026217|NCT01186744|BG001|Baseline|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
11026218|NCT01186744|BG002|Baseline|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026219|NCT01186744|BG003|Baseline|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026220|NCT01186744|BG004|Baseline|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026221|NCT01186744|BG005|Baseline|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID or up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026222|NCT01186744|BG006|Baseline|Total|Total of all reporting groups
11026223|NCT01186744|FG000|Participant Flow|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for up to 24 continuous weeks during Period A (Initial Treatment)
11026224|NCT01186744|FG001|Participant Flow|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for up to 24 continuous weeks during Period A (Initial Treatment)
11026225|NCT01186744|FG002|Participant Flow|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026226|NCT01186744|FG003|Participant Flow|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026227|NCT01186744|FG004|Participant Flow|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026228|NCT01186744|FG005|Participant Flow|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026229|NCT01186744|OG000|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP690-550 5 mg for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026230|NCT01186744|OG001|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026231|NCT01186744|OG002|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026232|NCT01186744|OG003|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026233|NCT01186744|OG000|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026234|NCT01186744|OG002|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026235|NCT01186744|OG000|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026236|NCT01186744|OG001|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026237|NCT01186744|OG002|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026238|NCT01186744|OG003|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026239|NCT01186744|OG001|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026240|NCT01186744|OG002|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026241|NCT01186744|OG003|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026242|NCT01186744|OG000|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
11026243|NCT01186744|OG001|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
11026244|NCT01186744|OG000|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026245|NCT01186744|OG001|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026246|NCT01186744|OG003|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026247|NCT01186744|OG001|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026248|NCT01186744|OG000|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026249|NCT01186744|OG001|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026250|NCT01186744|OG002|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026251|NCT01186744|OG003|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026252|NCT01186744|OG000|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
11026253|NCT01186744|OG001|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
11026254|NCT01186744|OG001|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026255|NCT01186744|OG003|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
11026256|NCT01186744|EG000|Reported Event|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
11026257|NCT01186744|EG001|Reported Event|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
11026258|NCT01186744|EG002|Reported Event|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026259|NCT01186744|EG003|Reported Event|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026260|NCT01186744|EG004|Reported Event|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026261|NCT01186744|EG005|Reported Event|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
11026262|NCT01186770|BG000|Baseline|MNTX 150 mg|Participants received MNTX 150 mg (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026263|NCT01186770|BG001|Baseline|MNTX 300 mg|Participants received MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026264|NCT01186770|BG002|Baseline|MNTX 450 mg|Participants received MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026265|NCT01186770|BG003|Baseline|Placebo|Participants received 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).
11026266|NCT01186770|BG004|Baseline|Total|Total of all reporting groups
11026267|NCT01186770|FG000|Participant Flow|MNTX 150 mg|Participants received methylnaltrexone (MNTX) 150 milligrams (mg) (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally once daily (QD) for 28 days (4 weeks), then MNTX tablets at a dose as needed (PRN) for remaining 56 days (8 weeks).
11026268|NCT01186770|FG001|Participant Flow|MNTX 300 mg|Participants received MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026269|NCT01186770|FG002|Participant Flow|MNTX 450 mg|Participants received MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026270|NCT01186770|FG003|Participant Flow|Placebo|Participants received 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).
11026271|NCT01186770|OG000|Outcome|MNTX 150 mg|Participants received MNTX 150 mg (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11148914|NCT01867710|BG003|Baseline|Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148915|NCT01867710|BG004|Baseline|Total|Total of all reporting groups
11148916|NCT01867710|FG000|Participant Flow|Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID|Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148917|NCT01867710|FG001|Participant Flow|Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148918|NCT01867710|FG002|Participant Flow|Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148919|NCT01867710|FG003|Participant Flow|Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148920|NCT01867710|OG000|Outcome|Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID|Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11026272|NCT01186770|OG001|Outcome|MNTX 300 mg|Participants received MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026273|NCT01186770|OG002|Outcome|MNTX 450 mg|Participants received MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026274|NCT01186770|OG003|Outcome|Placebo|Participants received 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).
11026275|NCT01186770|EG000|Reported Event|MNTX 150 mg|Participants received MNTX 150 mg (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026276|NCT01186770|EG001|Reported Event|MNTX 300 mg|Participants received MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026277|NCT01186770|EG002|Reported Event|MNTX 450 mg|Participants received MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
11026278|NCT01186770|EG003|Reported Event|Placebo|Participants received 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).
11026279|NCT01186796|BG000|Baseline|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
11026280|NCT01186796|BG001|Baseline|Saline Group|"Subjects are given 3 consecutive weekly injections of Saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
11026281|NCT01186796|BG002|Baseline|Total|Total of all reporting groups
11026282|NCT01186796|FG000|Participant Flow|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
11026283|NCT01186796|FG001|Participant Flow|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
11026284|NCT01186796|OG000|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
11026285|NCT01186796|OG001|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
11026286|NCT01186796|EG000|Reported Event|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
11026287|NCT01186796|EG001|Reported Event|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
11026288|NCT01186809|BG000|Baseline|Cytokine Induced Killer|"Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)~in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals"
11026289|NCT01186809|FG000|Participant Flow|Cytokine Induced Killer|"Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)~in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals~This is a phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded CIK cells. Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor CIK cells will be administered according to a dose escalating program, starting 3 weeks after second DLI. CIK administrations will be separated by 3 weeks intervals. Standard treatment with unmanipulated DLI will be offered to patients refusing the proposal."
11026290|NCT01186809|OG000|Outcome|Cytokine Induced Killer|"Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)~in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals~This is a phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded CIK cells. Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor CIK cells will be administered according to a dose escalating program, starting 3 weeks after second DLI. CIK administrations will be separated by 3 weeks intervals. Standard treatment with unmanipulated DLI will be offered to patients refusing the proposal."
11026291|NCT01186809|EG000|Reported Event|Cytokine Induced Killer|"Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)~in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals~This is a phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded CIK cells. Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor CIK cells will be administered according to a dose escalating program, starting 3 weeks after second DLI. CIK administrations will be separated by 3 weeks intervals. Standard treatment with unmanipulated DLI will be offered to patients refusing the proposal."
11026292|NCT01186939|BG000|Baseline|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
11026293|NCT01186939|FG000|Participant Flow|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
11026294|NCT01186939|OG000|Outcome|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
11026295|NCT01186939|EG000|Reported Event|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
11026296|NCT01186978|BG000|Baseline|Single Arm|"This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.~Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week"
11026297|NCT01186978|FG000|Participant Flow|Single Arm|"This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.~Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week"
11026298|NCT01186978|OG000|Outcome|Single Arm|"This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.~Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week"
11026299|NCT01186978|EG000|Reported Event|Single Arm|"This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.~Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week"
11026300|NCT01187004|BG000|Baseline|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
11026301|NCT01187004|BG001|Baseline|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
11026302|NCT01187004|BG002|Baseline|Total|Total of all reporting groups
11026303|NCT01187004|FG000|Participant Flow|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
11026304|NCT01187004|FG001|Participant Flow|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
11026305|NCT01187004|OG000|Outcome|Acute Lung Injury|Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation
11026306|NCT01187004|OG000|Outcome|ICU-LOS in Patients Developing ALI|Intensive care unit length of stay in patients developing acute lung injury. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
11026307|NCT01187004|OG001|Outcome|Control Group|patients who didn't develope ALI. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
11026308|NCT01187004|EG000|Reported Event|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
11026309|NCT01187004|EG001|Reported Event|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
11026310|NCT01187017|BG000|Baseline|Fludarabine/Cyclophosphamide in Participants With Severe Aplastic Anemia|Participants with Severe Aplastic Anemia will receive Fludarabine at 125 mg/m squared plus Cyclophosphamide at 60 mg/kg (Flu/Cy).
11026311|NCT01187017|FG000|Participant Flow|Fludarabine/Cyclophosphamide in Participants With Severe Aplastic Anemia|Participants with Severe Aplastic Anemia will receive Fludarabine at 125 mg/m squared plus Cyclophosphamide at 60 mg/kg (Flu/Cy).
11026312|NCT01187017|OG000|Outcome|Fludarabine/Cyclophosphamide in Participants With Severe Aplastic Anemia|Participants with Severe Aplastic Anemia will receive Fludarabine at 125 mg/m squared plus Cyclophosphamide at 60 mg/kg (Flu/Cy).
11026313|NCT01187017|OG000|Outcome|Fludarabine/Cyclophosphamide in Participants With Severe Aplastic Anemia at 3 Months|Participants with Severe Aplastic Anemia will receive Fludarabine at 125 mg/m squared plus Cyclophosphamide at 60 mg/kg (Flu/Cy).
11026314|NCT01187017|OG000|Outcome|Fludarabine/ Cyclophosphamide in Participants With Severe Aplastic Anemia|Participants with Severe Aplastic Anemia will receive Fludarabine at 125 mg/m squared plus Cyclophosphamide at 60 mg/kg (Flu/Cy).
11026315|NCT01187017|EG000|Reported Event|Fludarabine/Cyclophosphamide in Participants With Severe Aplastic Anemia|Participants with Severe Aplastic Anemia will receive Fludarabine at 125 mg/m squared plus Cyclophosphamide at 60 mg/kg (Flu/Cy).
11026316|NCT01187043|BG000|Baseline|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026317|NCT01187043|BG001|Baseline|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026318|NCT01187043|BG002|Baseline|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026319|NCT01187043|BG003|Baseline|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026320|NCT01187043|BG004|Baseline|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026321|NCT01187043|BG005|Baseline|Total|Total of all reporting groups
11026322|NCT01187043|FG000|Participant Flow|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026323|NCT01187043|FG001|Participant Flow|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026324|NCT01187043|FG002|Participant Flow|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026325|NCT01187043|FG003|Participant Flow|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026326|NCT01187043|FG004|Participant Flow|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026327|NCT01187043|OG000|Outcome|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026328|NCT01187043|OG001|Outcome|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026329|NCT01187043|OG002|Outcome|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026330|NCT01187043|OG003|Outcome|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026331|NCT01187043|OG004|Outcome|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026332|NCT01187043|EG000|Reported Event|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026333|NCT01187043|EG001|Reported Event|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026334|NCT01187043|EG002|Reported Event|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026335|NCT01187043|EG003|Reported Event|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026336|NCT01187043|EG004|Reported Event|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
11026337|NCT01187095|BG000|Baseline|Counselling|"Does couples in IVF treatment benefit from emotional disclosure~Expressive writing: 3 consecutive days of writing"
11026338|NCT01187095|BG001|Baseline|Control|"Neutral writing exercise~Active ctrl: Control"
11026339|NCT01187095|BG002|Baseline|Total|Total of all reporting groups
11026340|NCT01187095|FG000|Participant Flow|Counselling|"Do couples in IVF treatment benefit from emotional disclosure~Expressive writing: 3 consecutive days of writing"
11026341|NCT01187095|FG001|Participant Flow|Control|"Neutral writing exercise~Active ctrl: Control"
11026342|NCT01187095|OG000|Outcome|Counselling|"Do couples in IVF treatment benefit from emotional disclosure~Expressive writing: 3 consecutive days of writing"
11026343|NCT01187095|OG001|Outcome|Control|"Neutral writing exercise~Active ctrl: Control"
11026344|NCT01187095|EG000|Reported Event|Counselling|"Do couples in IVF treatment benefit from emotional disclosure~Expressive writing: 3 consecutive days of writing"
11026345|NCT01187095|EG001|Reported Event|Control|"Neutral writing exercise~Active ctrl: Control"
11026346|NCT01187329|BG000|Baseline|Hyperinsulinemic Normoglycemic Clamp (HNC)|"Patients will be randomized to receive treatment with HNC during cardiac surgery.~hyperinsulinemic normoglycemic clamp (HNC): Prior to anesthetic induction, a baseline blood glucose value will be obtained, followed by an insulin infusion of 5 mU.Kg-1.min-1. When blood glucose is <110 mg/dL, a variable continuous infusion of glucose (dextrose 20%) supplemented with potassium (40 mEq/L) and phosphate (30 mmol/L) is administered to preserve normoglycemia (80-110 mg/dL). The glucose infusion is titrated to target glucose levels by checking blood glucose every 5 - 15 min with Accu-Check (Roche Diagnostics, Switzerland) glucose monitor. At sternal closure, insulin infusion is decreased to 1 mU/Kg/min. On admission to the ICU, insulin treatment follows the ICU protocol. The dextrose infusion is slowly weaned off over 2 - 4 hrs maintaining blood glucose > 80 mg/dL. Arterial blood glucose is measured every 30 - 60 min for 2 hrs, then, as stated in ICU protocol."
11026347|NCT01187329|BG001|Baseline|Standard Glucose Management|"Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.~control group: Baseline arterial blood glucose will be obtained before anesthetic induction. Repeat measurements are performed every 30-90 min. Glucose >150 on CPB will receive insulin according to intraoperative protocol. After surgery, insulin is given according to ICU protocol. Target glucose < 180 mg/dL."
11026348|NCT01187329|BG002|Baseline|Total|Total of all reporting groups
11026349|NCT01187329|FG000|Participant Flow|Hyperinsulinemic Normoglycemic Clamp (HNC)|"Patients will be randomized to receive treatment with HNC during cardiac surgery.~hyperinsulinemic normoglycemic clamp (HNC): Prior to anesthetic induction, a baseline blood glucose value will be obtained, followed by an insulin infusion of 5 mU.Kg-1.min-1. When blood glucose is <110 mg/dL, a variable continuous infusion of glucose (dextrose 20%) supplemented with potassium (40 mEq/L) and phosphate (30 mmol/L) is administered to preserve normoglycemia (80-110 mg/dL). The glucose infusion is titrated to target glucose levels by checking blood glucose every 5 - 15 min with Accu-Check (Roche Diagnostics, Switzerland) glucose monitor. At sternal closure, insulin infusion is decreased to 1 mU/Kg/min. On admission to the ICU, insulin treatment follows the ICU protocol. The dextrose infusion is slowly weaned off over 2 - 4 hrs maintaining blood glucose > 80 mg/dL. Arterial blood glucose is measured every 30 - 60 min for 2 hrs, then, as stated in ICU protocol."
11026350|NCT01187329|FG001|Participant Flow|Standard Glucose Management|"Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.~control group: Baseline arterial blood glucose will be obtained before anesthetic induction. Repeat measurements are performed every 30-90 min. Glucose >150 on CPB will receive insulin according to intraoperative protocol. After surgery, insulin is given according to ICU protocol. Target glucose < 180 mg/dL."
11026351|NCT01187329|OG000|Outcome|Hyperinsulinemic Normoglycemic Clamp (HNC)|"Patients will be randomized to receive treatment with HNC during cardiac surgery.~hyperinsulinemic normoglycemic clamp (HNC): Prior to anesthetic induction, a baseline blood glucose value will be obtained, followed by an insulin infusion of 5 mU.Kg-1.min-1. When blood glucose is <110 mg/dL, a variable continuous infusion of glucose (dextrose 20%) supplemented with potassium (40 mEq/L) and phosphate (30 mmol/L) is administered to preserve normoglycemia (80-110 mg/dL). The glucose infusion is titrated to target glucose levels by checking blood glucose every 5 - 15 min with Accu-Check (Roche Diagnostics, Switzerland) glucose monitor. At sternal closure, insulin infusion is decreased to 1 mU/Kg/min. On admission to the ICU, insulin treatment follows the ICU protocol. The dextrose infusion is slowly weaned off over 2 - 4 hrs maintaining blood glucose > 80 mg/dL. Arterial blood glucose is measured every 30 - 60 min for 2 hrs, then, as stated in ICU protocol."
11026352|NCT01187329|OG001|Outcome|Standard Glucose Management|"Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.~control group: Baseline arterial blood glucose will be obtained before anesthetic induction. Repeat measurements are performed every 30-90 min. Glucose >150 on CPB will receive insulin according to intraoperative protocol. After surgery, insulin is given according to ICU protocol. Target glucose < 180 mg/dL."
11026353|NCT01187329|EG000|Reported Event|Hyperinsulinemic Normoglycemic Clamp (HNC)|"Patients will be randomized to receive treatment with HNC during cardiac surgery.~hyperinsulinemic normoglycemic clamp (HNC): Prior to anesthetic induction, a baseline blood glucose value will be obtained, followed by an insulin infusion of 5 mU.Kg-1.min-1. When blood glucose is <110 mg/dL, a variable continuous infusion of glucose (dextrose 20%) supplemented with potassium (40 mEq/L) and phosphate (30 mmol/L) is administered to preserve normoglycemia (80-110 mg/dL). The glucose infusion is titrated to target glucose levels by checking blood glucose every 5 - 15 min with Accu-Check (Roche Diagnostics, Switzerland) glucose monitor. At sternal closure, insulin infusion is decreased to 1 mU/Kg/min. On admission to the ICU, insulin treatment follows the ICU protocol. The dextrose infusion is slowly weaned off over 2 - 4 hrs maintaining blood glucose > 80 mg/dL. Arterial blood glucose is measured every 30 - 60 min for 2 hrs, then, as stated in ICU protocol."
11026354|NCT01187329|EG001|Reported Event|Standard Glucose Management|"Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.~control group: Baseline arterial blood glucose will be obtained before anesthetic induction. Repeat measurements are performed every 30-90 min. Glucose >150 on CPB will receive insulin according to intraoperative protocol. After surgery, insulin is given according to ICU protocol. Target glucose < 180 mg/dL."
11026355|NCT01187355|BG000|Baseline|Alcon MPDS|Multi-purpose disinfecting contact lens solution
11026356|NCT01187355|BG001|Baseline|Renu Fresh MPS|Multi-purpose contact lens solution
11026357|NCT01187355|BG002|Baseline|Total|Total of all reporting groups
11026358|NCT01187355|FG000|Participant Flow|Alcon MPDS|Multi-purpose disinfecting contact lens solution
11026359|NCT01187355|FG001|Participant Flow|Renu Fresh MPS|Multi-purpose contact lens solution
11026360|NCT01187355|OG000|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
11026361|NCT01187355|OG001|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
11026362|NCT01187355|EG000|Reported Event|Alcon MPDS|Multi-purpose disinfecting contact lens solution
11026363|NCT01187355|EG001|Reported Event|Renu Fresh MPS|Multi-purpose contact lens solution
11026364|NCT01187381|BG000|Baseline|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
11148921|NCT01867710|OG001|Outcome|Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11026365|NCT01187381|FG000|Participant Flow|Participants With Breast Cancer|Participants with early or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
11026366|NCT01187381|OG000|Outcome|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
11026367|NCT01187381|EG000|Reported Event|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
11026368|NCT01187407|BG000|Baseline|12 or 18 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11026369|NCT01187407|BG001|Baseline|6 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
11026370|NCT01187407|BG002|Baseline|Placebo + SSRI (Randomized Participants)|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
11026371|NCT01187407|BG003|Baseline|Placebo + SSRI (Non-randomized Participants)|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
11026372|NCT01187407|BG004|Baseline|Total|Total of all reporting groups
11026373|NCT01187407|FG000|Participant Flow|Placebo + SSRI (Pre-randomized Participants)|Placebo: administered orally, once daily (QD) for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11026374|NCT01187407|FG001|Participant Flow|12 or 18 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, QD for 8 weeks, adjunctive to an SSRI
11026375|NCT01187407|FG002|Participant Flow|6 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
11225832|NCT02370511|OG000|Outcome|Native Mitral Valve With Severe MAC|"Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11026376|NCT01187407|FG003|Participant Flow|Placebo + SSRI (Randomized Participants)|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
11026377|NCT01187407|FG004|Participant Flow|Placebo + SSRI (Non-randomized Participants)|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
11026378|NCT01187407|OG000|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11026379|NCT01187407|OG001|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
11026380|NCT01187407|OG002|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
11026381|NCT01187407|OG001|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI)
11026382|NCT01187407|OG000|Outcome|LY2216684|LY2216684: flexible dose of 12 or 18 milligrams (mg) or fixed dose of 6 mg, administered orally, once daily (QD)
11026383|NCT01187407|EG000|Reported Event|Placebo + SSRI (Pre-randomized) - CF Phase|"Placebo: administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all enrolled who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Confirmation (CF) Phase."
11026384|NCT01187407|EG001|Reported Event|12 or 18 mg LY2216684 + SSRI (Randomized) - AT Phase|"LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11026385|NCT01187407|EG002|Reported Event|6 mg LY2216684 + SSRI (Randomized) - AT Phase|"LY2216684: fixed dose of 6 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11026386|NCT01187407|EG003|Reported Event|Placebo + SSRI (Randomized) - AT Phase|"Placebo: administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11026387|NCT01187407|EG004|Reported Event|Placebo + SSRI (Non-randomized) - AT Phase|"Placebo: administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all non-randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
11026388|NCT01187407|EG005|Reported Event|Placebo + SSRI (Pre-randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11026389|NCT01187407|EG006|Reported Event|12 or 18 mg LY2216684 + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11026390|NCT01187407|EG007|Reported Event|6 mg LY2216684 + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11026391|NCT01187407|EG008|Reported Event|Placebo + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11026392|NCT01187407|EG009|Reported Event|Placebo + SSRI (Non-randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all non-randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11026393|NCT01187446|BG000|Baseline|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
11026394|NCT01187446|BG001|Baseline|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day concurrent and continuing for 8 weeks total."
11026395|NCT01187446|BG002|Baseline|Total|Total of all reporting groups
11026396|NCT01187446|FG000|Participant Flow|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
11026397|NCT01187446|FG001|Participant Flow|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day continuing for 8 weeks total."
11026398|NCT01187446|OG000|Outcome|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
11026399|NCT01187446|OG001|Outcome|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day concurrent and continuing for 8 weeks total."
11026400|NCT01187446|EG000|Reported Event|TSEBT Only|TSEBT (12Gy) per institutional guidelines.
11026401|NCT01187446|EG001|Reported Event|TSEBT & Vorinostat|"TSEBT (12Gy) per institutional guidelines.~Vorinostat 400 mg daily starting one day prior to the initiation of TSEBT."
11026402|NCT01187498|BG000|Baseline|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
11026403|NCT01187498|BG001|Baseline|Drug Therapy|Individually titrated, extended release oxybutynin chloride
11026404|NCT01187498|BG002|Baseline|Total|Total of all reporting groups
11026405|NCT01187498|FG000|Participant Flow|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
11026406|NCT01187498|FG001|Participant Flow|Drug Therapy|Individually titrated, extended-release oxybutynin chloride, 5-30mg
11026407|NCT01187498|OG000|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
11026408|NCT01187498|OG001|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
11026409|NCT01187498|EG000|Reported Event|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
11026410|NCT01187498|EG001|Reported Event|Drug Therapy|Individually titrated, extended release oxybutynin chloride
11026411|NCT01187511|BG000|Baseline|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
11026412|NCT01187511|BG001|Baseline|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
11026413|NCT01187511|BG002|Baseline|Total|Total of all reporting groups
11026414|NCT01187511|FG000|Participant Flow|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
11026415|NCT01187511|FG001|Participant Flow|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
11026416|NCT01187511|OG000|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
11026417|NCT01187511|OG001|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
11026418|NCT01187511|EG000|Reported Event|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
11026419|NCT01187511|EG001|Reported Event|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
11026420|NCT01187550|BG000|Baseline|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
11026421|NCT01187550|BG001|Baseline|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
11026422|NCT01187550|BG002|Baseline|Total|Total of all reporting groups
11026423|NCT01187550|FG000|Participant Flow|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
11026424|NCT01187550|FG001|Participant Flow|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
11026425|NCT01187550|OG000|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
11026426|NCT01187550|OG001|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
11026427|NCT01187550|EG000|Reported Event|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
11026428|NCT01187550|EG001|Reported Event|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
11026429|NCT01187771|BG000|Baseline|Laparoscopic Gastric Banding|
11026430|NCT01187771|BG001|Baseline|Continuous Positive Airway Pressure|
11026431|NCT01187771|BG002|Baseline|Total|Total of all reporting groups
11026432|NCT01187771|FG000|Participant Flow|Laparoscopic Gastric Banding|
11026433|NCT01187771|FG001|Participant Flow|Continuous Positive Airway Pressure|
11026434|NCT01187771|OG000|Outcome|Laparoscopic Gastric Banding|
11026435|NCT01187771|OG001|Outcome|Continuous Positive Airway Pressure|
11026436|NCT01187771|OG000|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
11026437|NCT01187771|OG001|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
10886757|NCT00496015|FG002|Participant Flow|Synflorix PRE Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
11026438|NCT01187771|EG000|Reported Event|Laparoscopic Gastric Banding|
11026439|NCT01187771|EG001|Reported Event|Continuous Positive Airway Pressure|
11026440|NCT01187901|BG000|Baseline|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
11026441|NCT01187901|BG001|Baseline|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
11026442|NCT01187901|BG002|Baseline|Total|Total of all reporting groups
11026443|NCT01187901|FG000|Participant Flow|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
11026444|NCT01187901|FG001|Participant Flow|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
11026445|NCT01187901|OG000|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
11026446|NCT01187901|OG001|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
11026447|NCT01187901|EG000|Reported Event|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
11026448|NCT01187901|EG001|Reported Event|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
11066363|NCT01391832|BG000|Baseline|Sham rTMS|"Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)~Repetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.~Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma."
11066364|NCT01391832|BG001|Baseline|Active rTMS|"Active Repetitive Transcranial Magnet Stimulation treatment~Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex~Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.~Repetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil was be placed over over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46) and stimulation provided at 1 Hz (1.5-2.0 Tesla strength, 100 - 300 microseconds."
11066365|NCT01391832|BG002|Baseline|Total|Total of all reporting groups
11148922|NCT01867710|OG002|Outcome|Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11026449|NCT01187914|BG000|Baseline|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
11026450|NCT01187914|FG000|Participant Flow|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
11026451|NCT01187914|OG000|Outcome|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
11026452|NCT01187914|EG000|Reported Event|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
11026453|NCT01187953|BG000|Baseline|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
11026454|NCT01187953|BG001|Baseline|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
11026455|NCT01187953|BG002|Baseline|Total|Total of all reporting groups
11026456|NCT01187953|FG000|Participant Flow|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
11026457|NCT01187953|FG001|Participant Flow|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
11026458|NCT01187953|OG000|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
11026459|NCT01187953|OG001|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
11026460|NCT01187953|EG000|Reported Event|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
11026461|NCT01187953|EG001|Reported Event|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
11026462|NCT01188109|BG000|Baseline|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
11026463|NCT01188109|FG000|Participant Flow|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
11026464|NCT01188109|OG000|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
11026465|NCT01188109|EG000|Reported Event|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
11026466|NCT01188226|BG000|Baseline|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
11026467|NCT01188226|FG000|Participant Flow|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material~Denture teeth: Denture teeth made of nano hybrid composite material"
11026468|NCT01188226|OG000|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
11026469|NCT01188226|OG001|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
11026470|NCT01188226|OG001|Outcome|Lower Denture|Participants with lower denture in use 18 months after denture completion. Denture teeth are made of nano hybrid composite material
11026471|NCT01188226|OG000|Outcome|Upper Denture|Participants wearing upper denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
11026472|NCT01188226|OG001|Outcome|Lower Denture|Participants wearing lower denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
11026473|NCT01188226|OG000|Outcome|Participants With Nano Hybrid Composite Dentures|Denture teeth are made of nano hybrid composite material
11026474|NCT01188226|OG000|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
11026475|NCT01188226|OG001|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
11026476|NCT01188226|OG002|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
11026477|NCT01188226|OG000|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
11026478|NCT01188226|OG000|Outcome|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material~Denture teeth: Denture teeth made of nano hybrid composite material"
11026479|NCT01188226|EG000|Reported Event|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
11026480|NCT01188343|BG000|Baseline|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
11026481|NCT01188343|BG001|Baseline|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
11026482|NCT01188343|BG002|Baseline|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
11026483|NCT01188343|BG003|Baseline|Total|Total of all reporting groups
11026484|NCT01188343|FG000|Participant Flow|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
11026485|NCT01188343|FG001|Participant Flow|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
11026486|NCT01188343|FG002|Participant Flow|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0
11026487|NCT01188343|OG000|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
11026488|NCT01188343|OG001|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
11026489|NCT01188343|OG002|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
11026490|NCT01188343|OG000|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
11026491|NCT01188343|OG001|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
11026492|NCT01188343|OG002|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
11026493|NCT01188343|EG000|Reported Event|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
11026494|NCT01188343|EG001|Reported Event|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
11026495|NCT01188343|EG002|Reported Event|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
11026496|NCT01188369|BG000|Baseline|Levosimendan|"infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation~levosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation."
11026497|NCT01188369|BG001|Baseline|Placebo|"Identical placebo~placebo drug: Intravenous infusion, colour identical to levosimendan"
11026498|NCT01188369|BG002|Baseline|Total|Total of all reporting groups
11026499|NCT01188369|FG000|Participant Flow|Levosimendan|"infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation~levosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation."
11026500|NCT01188369|FG001|Participant Flow|Placebo|"Identical placebo~placebo drug: Intravenous infusion, colour identical to levosimendan"
11026501|NCT01188369|OG000|Outcome|Levosimendan|"infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation~levosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation."
11026502|NCT01188369|OG001|Outcome|Placebo|"Identical placebo~placebo drug: Intravenous infusion, colour identical to levosimendan"
11026503|NCT01188369|EG000|Reported Event|Levosimendan|"infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation~levosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation."
11026504|NCT01188369|EG001|Reported Event|Placebo|"Identical placebo~placebo drug: Intravenous infusion, colour identical to levosimendan"
11026505|NCT01188421|BG000|Baseline|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)~Buprenorphine/naloxone: up to 8/2 mg SL per day"
11026506|NCT01188421|BG001|Baseline|Tramadol ER|"Oral tramadol tablets (or placebo)~Tramadol ER: up to 600 mg per day"
11026507|NCT01188421|BG002|Baseline|Clonidine|"Oral clonidine tablets (or placebo)~Clonidine: up to 0.8 mg per day (oral)"
11026508|NCT01188421|BG003|Baseline|Total|Total of all reporting groups
11026509|NCT01188421|FG000|Participant Flow|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)~Buprenorphine/naloxone: up to 8/2 mg SL per day"
11026510|NCT01188421|FG001|Participant Flow|Tramadol ER|"Oral tramadol tablets (or placebo)~Tramadol ER: up to 600 mg per day"
11026511|NCT01188421|FG002|Participant Flow|Clonidine|"Oral clonidine tablets (or placebo)~Clonidine: up to 0.8 mg per day (oral)"
11026512|NCT01188421|OG000|Outcome|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)~Buprenorphine/naloxone: up to 8/2 mg SL per day"
11026513|NCT01188421|OG001|Outcome|Tramadol ER|"Oral tramadol tablets (or placebo)~Tramadol ER: up to 600 mg per day"
11026514|NCT01188421|OG002|Outcome|Clonidine|"Oral clonidine tablets (or placebo)~Clonidine: up to 0.8 mg per day (oral)"
11026515|NCT01188421|EG000|Reported Event|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)~Buprenorphine/naloxone: up to 8/2 mg SL per day"
11026516|NCT01188421|EG001|Reported Event|Tramadol ER|"Oral tramadol tablets (or placebo)~Tramadol ER: up to 600 mg per day"
11026517|NCT01188421|EG002|Reported Event|Clonidine|"Oral clonidine tablets (or placebo)~Clonidine: up to 0.8 mg per day (oral)"
11026518|NCT01188447|BG000|Baseline|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
11026519|NCT01188447|FG000|Participant Flow|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
11026520|NCT01188447|OG000|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
11026521|NCT01188447|OG000|Outcome|Eligible Patients|eligible patients evaluated with the Canadian C-Spine Rule
11026522|NCT01188447|EG000|Reported Event|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
11026523|NCT01188460|BG000|Baseline|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
11026524|NCT01188460|BG001|Baseline|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
11026525|NCT01188460|BG002|Baseline|Total|Total of all reporting groups
11026526|NCT01188460|FG000|Participant Flow|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
10886758|NCT00496015|FG003|Participant Flow|Synflorix POST Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
11026527|NCT01188460|FG001|Participant Flow|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
11026528|NCT01188460|OG000|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
11026529|NCT01188460|OG001|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
11026530|NCT01188460|EG000|Reported Event|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
11026531|NCT01188460|EG001|Reported Event|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
11026532|NCT01188499|BG000|Baseline|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026533|NCT01188499|BG001|Baseline|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026534|NCT01188499|BG002|Baseline|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026535|NCT01188499|BG003|Baseline|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
11026536|NCT01188499|BG004|Baseline|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
11026537|NCT01188499|BG005|Baseline|Total|Total of all reporting groups
11026538|NCT01188499|FG000|Participant Flow|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026539|NCT01188499|FG001|Participant Flow|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026540|NCT01188499|FG002|Participant Flow|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026541|NCT01188499|FG003|Participant Flow|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
11026542|NCT01188499|FG004|Participant Flow|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
11026543|NCT01188499|OG000|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026544|NCT01188499|OG001|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026545|NCT01188499|OG002|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11148923|NCT01867710|OG003|Outcome|Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11026546|NCT01188499|OG003|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
11026547|NCT01188499|OG004|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
11026548|NCT01188499|EG000|Reported Event|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026549|NCT01188499|EG001|Reported Event|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026550|NCT01188499|EG002|Reported Event|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
11026551|NCT01188499|EG003|Reported Event|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
11026552|NCT01188499|EG004|Reported Event|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
11026553|NCT01188538|BG000|Baseline|Epiduo Gel|
11026554|NCT01188538|BG001|Baseline|Benzoyl Peroxide (BPO) Gel|
10886759|NCT00496015|FG004|Participant Flow|Mencevax + Infanrix Hexa Group|Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
11026555|NCT01188538|BG002|Baseline|Total|Total of all reporting groups
11026556|NCT01188538|FG000|Participant Flow|Epiduo Gel|
11026557|NCT01188538|FG001|Participant Flow|Benzoyl Peroxide (BPO) Gel|
11026558|NCT01188538|OG000|Outcome|Epiduo Gel|
11026559|NCT01188538|OG001|Outcome|Benzoyl Peroxide (BPO) Gel|
11026560|NCT01188538|OG000|Outcome|Epiduo® Gel|Epiduo® Gel Topical to the face, once daily application in the evening
11026561|NCT01188538|OG001|Outcome|BPO Gel|BPO Gel Topical to the face, once daily application in the evening
11026562|NCT01188538|EG000|Reported Event|Epiduo Gel|
11026563|NCT01188538|EG001|Reported Event|Benzoyl Peroxide (BPO) Gel|
11026564|NCT01188551|BG000|Baseline|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
11026565|NCT01188551|BG001|Baseline|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
11026566|NCT01188551|BG002|Baseline|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
11026567|NCT01188551|BG003|Baseline|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
11026568|NCT01188551|BG004|Baseline|Total|Total of all reporting groups
11026569|NCT01188551|FG000|Participant Flow|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
11026570|NCT01188551|FG001|Participant Flow|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
11026571|NCT01188551|FG002|Participant Flow|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
11026572|NCT01188551|FG003|Participant Flow|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
11026573|NCT01188551|OG000|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
11026574|NCT01188551|OG001|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
11026575|NCT01188551|OG002|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
11026576|NCT01188551|OG003|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
11026577|NCT01188551|EG000|Reported Event|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
11026578|NCT01188551|EG001|Reported Event|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
11026579|NCT01188551|EG002|Reported Event|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
11026580|NCT01188551|EG003|Reported Event|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
11026581|NCT01188564|BG000|Baseline|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
11026582|NCT01188564|BG001|Baseline|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
11026583|NCT01188564|BG002|Baseline|Total|Total of all reporting groups
11026584|NCT01188564|FG000|Participant Flow|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
11026585|NCT01188564|FG001|Participant Flow|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
11026586|NCT01188564|OG000|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
11026587|NCT01188564|OG001|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
11026588|NCT01188564|EG000|Reported Event|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
11026589|NCT01188564|EG001|Reported Event|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
11026590|NCT01188577|BG000|Baseline|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
11026591|NCT01188577|BG001|Baseline|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
11026592|NCT01188577|BG002|Baseline|Total|Total of all reporting groups
11026593|NCT01188577|FG000|Participant Flow|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
11026594|NCT01188577|FG001|Participant Flow|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
11026595|NCT01188577|OG000|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
11026596|NCT01188577|OG001|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
11026597|NCT01188577|EG000|Reported Event|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
11026598|NCT01188577|EG001|Reported Event|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
11026599|NCT01188603|BG000|Baseline|Flibanserin|100mg Flibanserin administered orally once daily
11026600|NCT01188603|FG000|Participant Flow|Flibanserin|100mg Flibanserin administered orally once daily
11026601|NCT01188603|OG000|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
11026602|NCT01188603|EG000|Reported Event|Flibanserin|100mg Flibanserin administered orally once daily
11026603|NCT01188655|BG000|Baseline|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
11026604|NCT01188655|FG000|Participant Flow|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
11026605|NCT01188655|OG000|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
11026606|NCT01188655|EG000|Reported Event|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
11026607|NCT01188668|BG000|Baseline|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
11026608|NCT01188668|FG000|Participant Flow|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole (ARIP) as a single oral dose of 5 milligrams (mg) Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
11026609|NCT01188668|OG000|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
11026610|NCT01188668|OG001|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
11026611|NCT01188668|EG000|Reported Event|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
11026612|NCT01188668|EG001|Reported Event|DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state).
11026613|NCT01188668|EG002|Reported Event|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 7 though Day 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
11026614|NCT01188681|BG000|Baseline|Phase 1: 15 mg/kg TRU-016|"TRU-016 (15 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026615|NCT01188681|BG001|Baseline|Phase 1: 20 mg/kg TRU-016|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026616|NCT01188681|BG002|Baseline|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026617|NCT01188681|BG003|Baseline|Phase 2: Bendamustine|"Bendamustine alone (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026618|NCT01188681|BG004|Baseline|Total|Total of all reporting groups
11026619|NCT01188681|FG000|Participant Flow|Phase 1 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
11026620|NCT01188681|FG001|Participant Flow|Phase 1 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
11026621|NCT01188681|FG002|Participant Flow|Phase 2 TRU-016 and Bendamustine|Patients in the combination arm received otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles. In both arms, bendamustine (70 mg/m2) was administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
11026622|NCT01188681|FG003|Participant Flow|Phase 2 Bendamustine|Patients in the bendamustine arm received bendamustine (70 mg/m2) administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
11026623|NCT01188681|OG000|Outcome|Phase 1 15 mg/kg TRU-016|15 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
11026624|NCT01188681|OG001|Outcome|Phase 1 20 mg/kg TRU-016|20 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
11026625|NCT01188681|OG002|Outcome|TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026626|NCT01188681|OG003|Outcome|Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026627|NCT01188681|OG000|Outcome|Phase 2: TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026628|NCT01188681|OG001|Outcome|Phase 2: Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026629|NCT01188681|OG002|Outcome|Phase 1: 15 mg/kg TRU-016 +Beendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
11026630|NCT01188681|OG003|Outcome|Phase 1: 20 mg/kg TRU-016 +Bendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
11026631|NCT01188681|EG000|Reported Event|Phase 1: 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
11026632|NCT01188681|EG001|Reported Event|Phase 1: 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
11026633|NCT01188681|EG002|Reported Event|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026634|NCT01188681|EG003|Reported Event|Phase 2:Bendamustine|"Bendamustine alone (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
11026635|NCT01188694|BG000|Baseline|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
11026636|NCT01188694|BG001|Baseline|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
11026637|NCT01188694|BG002|Baseline|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
11026638|NCT01188694|BG003|Baseline|Total|Total of all reporting groups
11026639|NCT01188694|FG000|Participant Flow|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
11026640|NCT01188694|FG001|Participant Flow|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
11026641|NCT01188694|FG002|Participant Flow|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
11026642|NCT01188694|OG000|Outcome|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
11026643|NCT01188694|OG001|Outcome|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
11026644|NCT01188694|OG002|Outcome|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
11026645|NCT01188694|EG000|Reported Event|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
11026646|NCT01188694|EG001|Reported Event|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
11026647|NCT01188694|EG002|Reported Event|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
11026648|NCT01188772|BG000|Baseline|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026649|NCT01188772|BG001|Baseline|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026650|NCT01188772|BG002|Baseline|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026651|NCT01188772|BG003|Baseline|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
11026652|NCT01188772|BG004|Baseline|Total|Total of all reporting groups
11026653|NCT01188772|FG000|Participant Flow|Sofosbuvir 200 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+pegylated interferon alfa-2a (PEG)+ribavirin (RBV) for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
11026654|NCT01188772|FG001|Participant Flow|Sofosbuvir 400 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
11026655|NCT01188772|FG002|Participant Flow|Placebo (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
11026656|NCT01188772|FG003|Participant Flow|Sofosbuvir 400 mg (Genotype 2/3)|Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks.
11026657|NCT01188772|OG000|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026658|NCT01188772|OG001|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026659|NCT01188772|OG002|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026660|NCT01188772|OG003|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
11026661|NCT01188772|OG000|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
11026662|NCT01188772|OG001|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
11026663|NCT01188772|OG002|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
11026664|NCT01188772|EG000|Reported Event|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026665|NCT01188772|EG001|Reported Event|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026666|NCT01188772|EG002|Reported Event|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
11026667|NCT01188772|EG003|Reported Event|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
11026668|NCT01188811|BG000|Baseline|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
11026669|NCT01188811|BG001|Baseline|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
11026670|NCT01188811|BG002|Baseline|Total|Total of all reporting groups
11026671|NCT01188811|FG000|Participant Flow|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
11026672|NCT01188811|FG001|Participant Flow|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
11026673|NCT01188811|OG000|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
11026674|NCT01188811|OG001|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
11026675|NCT01188811|EG000|Reported Event|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
11026676|NCT01188811|EG001|Reported Event|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
11026677|NCT01188876|BG000|Baseline|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
11026678|NCT01188876|FG000|Participant Flow|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
11026679|NCT01188876|OG000|Outcome|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
11026680|NCT01188876|EG000|Reported Event|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
11026681|NCT01188928|BG000|Baseline|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
11026682|NCT01188928|BG001|Baseline|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
11026683|NCT01188928|BG002|Baseline|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
11026684|NCT01188928|BG003|Baseline|Topical Suspension Vehicle|The topical suspension vehicle alone
11026685|NCT01188928|BG004|Baseline|Total|Total of all reporting groups
11026686|NCT01188928|FG000|Participant Flow|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
11026687|NCT01188928|FG001|Participant Flow|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
11026688|NCT01188928|FG002|Participant Flow|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
11026689|NCT01188928|FG003|Participant Flow|Topical Suspension Vehicle|The topical suspension vehicle alone
11026690|NCT01188928|OG000|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
11026691|NCT01188928|OG001|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
11026692|NCT01188928|OG002|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
10886760|NCT00496015|OG000|Outcome|Synflorix I Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
11026693|NCT01188928|OG003|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
11026694|NCT01188928|EG000|Reported Event|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
11026695|NCT01188928|EG001|Reported Event|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
11026696|NCT01188928|EG002|Reported Event|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
11026697|NCT01188928|EG003|Reported Event|Topical Suspension Vehicle|The topical suspension vehicle alone
11026698|NCT01188967|BG000|Baseline|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received placebo pills.
11026699|NCT01188967|BG001|Baseline|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received the active treatment: GSK598809 pills,60 mg/day.
11026700|NCT01188967|BG002|Baseline|Total|Total of all reporting groups
11026701|NCT01188967|FG000|Participant Flow|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received 60 mg GSK598809 pills, the active treatment, for 6 weeks.
11026702|NCT01188967|FG001|Participant Flow|Placebo Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
11026703|NCT01188967|OG000|Outcome|Placebo Treatment Group|
11026704|NCT01188967|OG001|Outcome|GSK598809 Treatment Group|
11026705|NCT01188967|OG000|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
11026706|NCT01188967|OG001|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
11026707|NCT01188967|EG000|Reported Event|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the placebo pills.
11026708|NCT01188967|EG001|Reported Event|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the GSK598809 pills, the active treatment.
11026709|NCT01189032|BG000|Baseline|Placebo|Placebo ophthalmic solution
11026710|NCT01189032|BG001|Baseline|Low Concentration|1% DE-089 ophthalmic solution
11026711|NCT01189032|BG002|Baseline|High Concentration|3% DE-089 ophthalmic solution
11026712|NCT01189032|BG003|Baseline|Total|Total of all reporting groups
11026713|NCT01189032|FG000|Participant Flow|Placebo|Placebo ophthalmic solution
11026714|NCT01189032|FG001|Participant Flow|Low Concentration|1% DE-089 ophthalmic solution
11026715|NCT01189032|FG002|Participant Flow|High Concentration|3% DE-089 ophthalmic solution
11026716|NCT01189032|OG000|Outcome|Placebo|Placebo ophthalmic solution
11026717|NCT01189032|OG001|Outcome|Low Concentration|1% DE-089 ophthalmic solution
11026718|NCT01189032|OG002|Outcome|High Concentration|3% DE-089 ophthalmic solution
11026719|NCT01189032|EG000|Reported Event|Placebo|Placebo ophthalmic solution
11026720|NCT01189032|EG001|Reported Event|Low Concentration|1% DE-089 ophthalmic solution
11026721|NCT01189032|EG002|Reported Event|High Concentration|3% DE-089 ophthalmic solution
11026722|NCT01189110|BG000|Baseline|Arm 1|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
11026723|NCT01189110|BG001|Baseline|Arm 2|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
11026724|NCT01189110|BG002|Baseline|Total|Total of all reporting groups
11026725|NCT01189110|FG000|Participant Flow|Arm 1|Intervention- true Stim Flex treatment
11026726|NCT01189110|FG001|Participant Flow|Arm 2|Placebo group- sham Stim Flex machine
11026727|NCT01189110|OG000|Outcome|Arm 1- Intervention|Receipt of auriculotherapy via a Stim Flex machine that provided full electrical flow of current to the ear probe.
11026728|NCT01189110|OG001|Outcome|Arm 2- Placebo|Receipt of sham auriculotherapy via a Stim Flex machine that disabled electrical flow of current to the ear probe.
11026729|NCT01189110|EG000|Reported Event|Arm 1- Intervention|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
11026730|NCT01189110|EG001|Reported Event|Arm 2- Placebo|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
11026731|NCT01189123|BG000|Baseline|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
11026732|NCT01189123|BG001|Baseline|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
11026733|NCT01189123|BG002|Baseline|Total|Total of all reporting groups
11026734|NCT01189123|FG000|Participant Flow|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone~1 dose of vaccine was given IM"
11026735|NCT01189123|FG001|Participant Flow|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
11026736|NCT01189123|OG000|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
11026737|NCT01189123|OG001|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
11026738|NCT01189123|EG000|Reported Event|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
11026739|NCT01189123|EG001|Reported Event|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
11026740|NCT01189136|BG000|Baseline|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
11026741|NCT01189136|BG001|Baseline|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
11026742|NCT01189136|BG002|Baseline|Total|Total of all reporting groups
11026743|NCT01189136|FG000|Participant Flow|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
11026744|NCT01189136|FG001|Participant Flow|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
11026745|NCT01189136|OG000|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
11026746|NCT01189136|OG001|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
11026747|NCT01189136|EG000|Reported Event|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
11026748|NCT01189136|EG001|Reported Event|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
11026749|NCT01189201|BG000|Baseline|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were~Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)~Empagliflozin plus linagliptin, individual tablets (fasted)~Empagliflozin plus linagliptin FDC A1 (fed)~Empagliflozin plus linagliptin FDC A3 (fasted)~Drug administrations were separated by a washout period of at least 35 days.~A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
11026750|NCT01189201|FG000|Participant Flow|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were~Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)~Empagliflozin plus linagliptin, individual tablets (fasted)~Empagliflozin plus linagliptin FDC A1 (fed)~Empagliflozin plus linagliptin FDC A3 (fasted)~Drug administrations were separated by a washout period of at least 35 days.~A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
11026751|NCT01189201|OG000|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
11026752|NCT01189201|OG001|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
11026753|NCT01189201|OG002|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
11026754|NCT01189201|OG003|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
11026755|NCT01189201|OG001|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
11026756|NCT01189201|OG001|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
11026757|NCT01189201|OG001|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
11026758|NCT01189201|OG001|Outcome|Empa Plus Linagliptin Indivdual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
11026759|NCT01189201|OG003|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
11026760|NCT01189201|EG000|Reported Event|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
11026761|NCT01189201|EG001|Reported Event|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
11026762|NCT01189201|EG002|Reported Event|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
11026763|NCT01189201|EG003|Reported Event|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
11026764|NCT01189240|BG000|Baseline|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026765|NCT01189240|FG000|Participant Flow|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026766|NCT01189240|FG001|Participant Flow|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026767|NCT01189240|FG002|Participant Flow|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026768|NCT01189240|OG000|Outcome|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026769|NCT01189240|OG000|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026770|NCT01189240|OG001|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026771|NCT01189240|OG002|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026772|NCT01189240|OG000|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026773|NCT01189240|OG001|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026774|NCT01189240|OG002|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026775|NCT01189240|EG000|Reported Event|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11026776|NCT01189266|BG000|Baseline|Arm 1 Phase I Vorinostat 180 mg/m^2|"Patients in phase I received vorinostat at 180 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026777|NCT01189266|BG001|Baseline|Arm 2 Phase 1 Vorinostat 230 mg/m^2|"Patients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026778|NCT01189266|BG002|Baseline|Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2|"Patients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026779|NCT01189266|BG003|Baseline|Total|Total of all reporting groups
11026780|NCT01189266|FG000|Participant Flow|Arm 1, Phase I Vorinostat 180 mg/m^2|"Patients in phase I received vorinostat at 180 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026781|NCT01189266|FG001|Participant Flow|Arm 2, Phase I Vorinostat 230 mg/m^2|"Patients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11148924|NCT01867710|EG000|Reported Event|Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID|Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11026782|NCT01189266|FG002|Participant Flow|Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2|"Patients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026783|NCT01189266|OG000|Outcome|All Phase 1 Study Participants|"Arm 1, Phase 1 participants received vorinostat at 180 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks).~Arm 2, Phase 1 participants received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks)."
11026784|NCT01189266|OG000|Outcome|Arm 1, Phase I Vorinostat 180 mg/m^2|"Patients in phase I received vorinostat at 180 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026785|NCT01189266|OG001|Outcome|Arm 2, Phase I Vorinostat 230 mg/m^2|"Patients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026786|NCT01189266|OG002|Outcome|Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2|"Patients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026787|NCT01189266|EG000|Reported Event|Arm 1 Phase I Vorinostat 180 mg/m^2|"Patients in phase I received vorinostat at 180 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026788|NCT01189266|EG001|Reported Event|Arm 2 Phase 1 Vorinostat 230 mg/m^2|"Patients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026789|NCT01189266|EG002|Reported Event|Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2|"Patients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy~Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11026790|NCT01189279|BG000|Baseline|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
11026791|NCT01189279|BG001|Baseline|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
11026792|NCT01189279|BG002|Baseline|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
11026793|NCT01189279|BG003|Baseline|Total|Total of all reporting groups
11026794|NCT01189279|FG000|Participant Flow|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
10886761|NCT00496015|OG001|Outcome|Synflorix II Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
11026795|NCT01189279|FG001|Participant Flow|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
11026796|NCT01189279|FG002|Participant Flow|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
11026797|NCT01189279|OG000|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
11026798|NCT01189279|OG001|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
11026799|NCT01189279|OG002|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
11026800|NCT01189279|EG000|Reported Event|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
11026801|NCT01189279|EG001|Reported Event|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
11026802|NCT01189279|EG002|Reported Event|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
11026803|NCT01189292|BG000|Baseline|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
11026804|NCT01189292|BG001|Baseline|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
11026805|NCT01189292|BG002|Baseline|Total|Total of all reporting groups
11026806|NCT01189292|FG000|Participant Flow|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
11026807|NCT01189292|FG001|Participant Flow|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
11026808|NCT01189292|OG000|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
11026809|NCT01189292|OG001|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
11026810|NCT01189292|EG000|Reported Event|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
11026811|NCT01189292|EG001|Reported Event|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
11026812|NCT01189370|BG000|Baseline|Sorafenib|"Sorafenib 400 mg twice daily, 7 days a week~Sorafenib 600 mg twice daily, days 1-5 per week~Sorafenib 800 mg twice daily, days 1-5 per week~Sorafenib 1000 mg twice daily, says 1-5 per week"
11026813|NCT01189370|FG000|Participant Flow|Cohort 1: 400mg|Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
11026814|NCT01189370|FG001|Participant Flow|Cohort 2: 600 mg|Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
11026815|NCT01189370|FG002|Participant Flow|Cohort 3: 800mg|Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
11026816|NCT01189370|OG000|Outcome|Cohort 1: 400mg|Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
11026817|NCT01189370|OG001|Outcome|Cohort 2: 600 mg|Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
11026818|NCT01189370|OG002|Outcome|Cohort 3: 800mg|Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
11026819|NCT01189370|OG000|Outcome|Number of Participants With Disease Progression|Total number of participants that had disease progression while on study. Disease progression based on RECIST criteria.
11026820|NCT01189370|EG000|Reported Event|Sorafenib|"Sorafenib 400 mg twice daily, 7 days a week~Sorafenib 600 mg twice daily, days 1-5 per week~Sorafenib 800 mg twice daily, days 1-5 per week"
11026821|NCT01189409|BG000|Baseline|PEG Then Senna|"PEG in stepped bowel protocol~PEG then Senna: Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder)."
11026822|NCT01189409|BG001|Baseline|Senna Then PEG|"Stepped bowel protocol with Senna then PEG~Senna then PEG: Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder)."
11026823|NCT01189409|BG002|Baseline|Total|Total of all reporting groups
11026824|NCT01189409|FG000|Participant Flow|PEG Then Senna|"PEG in stepped bowel protocol~PEG then Senna: Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder)."
11026825|NCT01189409|FG001|Participant Flow|Senna Then PEG|"Stepped bowel protocol with Senna then PEG~Senna then PEG: Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder)."
11026826|NCT01189409|OG000|Outcome|Polyethylene Glycol (PEG)|Those patients on PEG during either treatment period
11026827|NCT01189409|OG001|Outcome|Sennosides|Those patients on sennosides during either treatment period
11026828|NCT01189409|OG000|Outcome|Polyethylene Glycol (PEG)|Participants who completed both arms of the study and preferred PEG over Senna
11026829|NCT01189409|OG001|Outcome|Senna|Participants who completed both arms of the study and preferred Senna over PEG
11026830|NCT01189409|OG002|Outcome|No Preference|Participants who completed both arms of the study and had no preference in treatment
11026831|NCT01189409|OG000|Outcome|Polyethylene Glycol (PEG)|Patients on the stepped bowel protocol with PEG accompanied by placebo alternate for the first 3 weeks.
11026832|NCT01189409|OG001|Outcome|Senna|Patients on the stepped bowel protocol with Senna accompanied by placebo alternate for the first 3 weeks.
11026833|NCT01189409|OG000|Outcome|Polyethylene Glycol (PEG)|Patients on PEG during either treatment period
11026834|NCT01189409|OG001|Outcome|Senna|Patients on Senna during either treatment period
11026835|NCT01189409|EG000|Reported Event|Polyethylene Glycol (PEG)|Patients on PEG during either treatment period
11026836|NCT01189409|EG001|Reported Event|Senna|Patients on Senna during either treatment period
11026837|NCT01189461|BG000|Baseline|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
11026838|NCT01189461|FG000|Participant Flow|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
11026839|NCT01189461|OG000|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
11026840|NCT01189461|EG000|Reported Event|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
11026841|NCT01189487|BG000|Baseline|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
11026842|NCT01189487|FG000|Participant Flow|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
11026843|NCT01189487|OG000|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
11026844|NCT01189487|EG000|Reported Event|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
11026845|NCT01189500|BG000|Baseline|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. DVS SR 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
11026846|NCT01189500|FG000|Participant Flow|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen (TAMOX) 40 milligrams (mg) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
11026847|NCT01189500|OG000|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
11026848|NCT01189500|OG001|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
11026849|NCT01189500|EG000|Reported Event|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose on Period 1 / Day 1.
11026850|NCT01189500|EG001|Reported Event|DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28.
11026851|NCT01189500|EG002|Reported Event|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|Tamoxifen 40 mg as a single oral dose coadministered with DVS SR 100 mg as a single oral dose on Period 2 / Day 7.
11026852|NCT01189604|BG000|Baseline|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
11026853|NCT01189604|BG001|Baseline|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
11026854|NCT01189604|BG002|Baseline|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
11026855|NCT01189604|BG003|Baseline|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
11026856|NCT01189604|BG004|Baseline|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
11026857|NCT01189604|BG005|Baseline|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
11026858|NCT01189604|BG006|Baseline|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
11026859|NCT01189604|BG007|Baseline|Total|Total of all reporting groups
11026860|NCT01189604|FG000|Participant Flow|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
11026861|NCT01189604|FG001|Participant Flow|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
11026862|NCT01189604|FG002|Participant Flow|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
11026863|NCT01189604|FG003|Participant Flow|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
11026864|NCT01189604|FG004|Participant Flow|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
11026865|NCT01189604|FG005|Participant Flow|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
11026866|NCT01189604|FG006|Participant Flow|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
11026867|NCT01189604|OG000|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
11026868|NCT01189604|OG001|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
11026869|NCT01189604|OG002|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
11026870|NCT01189604|OG003|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
11026871|NCT01189604|OG004|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
11026872|NCT01189604|OG005|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
11026873|NCT01189604|OG006|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
11026874|NCT01189604|EG000|Reported Event|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
11026875|NCT01189604|EG001|Reported Event|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
11026876|NCT01189604|EG002|Reported Event|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
11026877|NCT01189604|EG003|Reported Event|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
11026878|NCT01189604|EG004|Reported Event|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
11026879|NCT01189604|EG005|Reported Event|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
11026880|NCT01189604|EG006|Reported Event|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
11026881|NCT01189617|BG000|Baseline|Male|Male Participants
11026882|NCT01189617|BG001|Baseline|Female|Female Participants
11026883|NCT01189617|BG002|Baseline|Total|Total of all reporting groups
11026884|NCT01189617|FG000|Participant Flow|Male|Male Participants
11026885|NCT01189617|FG001|Participant Flow|Female|Female Participants
11026886|NCT01189617|OG000|Outcome|Male|Male Participants
11026887|NCT01189617|OG001|Outcome|Female|Female Participants
11026888|NCT01189617|EG000|Reported Event|Male|Male Participants
11026889|NCT01189617|EG001|Reported Event|Female|Female Participants
11026890|NCT01189747|BG000|Baseline|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
11026891|NCT01189747|BG001|Baseline|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
11026892|NCT01189747|BG002|Baseline|Total|Total of all reporting groups
11026893|NCT01189747|FG000|Participant Flow|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
11026894|NCT01189747|FG001|Participant Flow|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
11026895|NCT01189747|OG000|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
11026896|NCT01189747|OG001|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
11026897|NCT01189747|EG000|Reported Event|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
11026898|NCT01189747|EG001|Reported Event|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
11026899|NCT01189760|BG000|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026900|NCT01189760|BG001|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026901|NCT01189760|BG002|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026902|NCT01189760|BG003|Baseline|Total|Total of all reporting groups
11026903|NCT01189760|FG000|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026904|NCT01189760|FG001|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026905|NCT01189760|FG002|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026906|NCT01189760|OG000|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026907|NCT01189760|OG001|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026908|NCT01189760|OG002|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026909|NCT01189760|EG000|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026910|NCT01189760|EG001|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026911|NCT01189760|EG002|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
11026912|NCT01189812|BG000|Baseline|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
11026913|NCT01189812|BG001|Baseline|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
11026914|NCT01189812|BG002|Baseline|Total|Total of all reporting groups
11026915|NCT01189812|FG000|Participant Flow|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
11026916|NCT01189812|FG001|Participant Flow|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
11026917|NCT01189812|OG000|Outcome|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
11026918|NCT01189812|OG001|Outcome|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
11026919|NCT01189812|EG000|Reported Event|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
11026920|NCT01189812|EG001|Reported Event|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
11026921|NCT01189890|BG000|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
11026922|NCT01189890|BG001|Baseline|Glimepiride|Glimepiride 1-6 mg QD
11026923|NCT01189890|BG002|Baseline|Total|Total of all reporting groups
11026924|NCT01189890|FG000|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
11026925|NCT01189890|FG001|Participant Flow|Glimepiride|Glimepiride 1-6 mg QD
11225833|NCT02370511|OG001|Outcome|Valve-in-Ring|"Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11026926|NCT01189890|OG000|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
11026927|NCT01189890|OG001|Outcome|Glimepiride|Glimepiride 1-6 mg QD
11026928|NCT01189890|EG000|Reported Event|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
11026929|NCT01189890|EG001|Reported Event|Glimepiride|Glimepiride 1-6 mg QD
11026930|NCT01190007|BG000|Baseline|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
11026931|NCT01190007|FG000|Participant Flow|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
11026932|NCT01190007|OG000|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
11026933|NCT01190007|EG000|Reported Event|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
11026934|NCT01190020|BG000|Baseline|Lubiprostone|
11026935|NCT01190020|BG001|Baseline|Placebo|
11026936|NCT01190020|BG002|Baseline|Total|Total of all reporting groups
11026937|NCT01190020|FG000|Participant Flow|Lubiprostone|Received 24 mcg of lubiprostone twice a day with meals.
11026938|NCT01190020|FG001|Participant Flow|Placebo|Received placebo twice a day with meals.
11026939|NCT01190020|OG000|Outcome|Lubiprostone|
11026940|NCT01190020|OG001|Outcome|Placebo|
11026941|NCT01190020|EG000|Reported Event|Lubiprostone|
11026942|NCT01190020|EG001|Reported Event|Placebo|
11026943|NCT01190085|BG000|Baseline|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026944|NCT01190085|BG001|Baseline|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026945|NCT01190085|BG002|Baseline|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026946|NCT01190085|BG003|Baseline|Total|Total of all reporting groups
11026947|NCT01190085|FG000|Participant Flow|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026948|NCT01190085|FG001|Participant Flow|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026949|NCT01190085|FG002|Participant Flow|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026950|NCT01190085|OG000|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026951|NCT01190085|OG001|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026952|NCT01190085|OG002|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026953|NCT01190085|EG000|Reported Event|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026954|NCT01190085|EG001|Reported Event|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026955|NCT01190085|EG002|Reported Event|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
11026956|NCT01190098|BG000|Baseline|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
11026957|NCT01190098|BG001|Baseline|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
11026958|NCT01190098|BG002|Baseline|Total|Total of all reporting groups
11026959|NCT01190098|FG000|Participant Flow|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
11026960|NCT01190098|FG001|Participant Flow|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
11026961|NCT01190098|OG000|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
11026962|NCT01190098|OG001|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
11026963|NCT01190098|EG000|Reported Event|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
11026964|NCT01190098|EG001|Reported Event|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
11026965|NCT01190124|BG000|Baseline|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
11026966|NCT01190124|BG001|Baseline|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
11026967|NCT01190124|BG002|Baseline|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
11026968|NCT01190124|BG003|Baseline|Total|Total of all reporting groups
11026969|NCT01190124|FG000|Participant Flow|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
11026970|NCT01190124|FG001|Participant Flow|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
11026971|NCT01190124|FG002|Participant Flow|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
11026972|NCT01190124|OG000|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
11026973|NCT01190124|OG001|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
11026974|NCT01190124|OG002|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
11026975|NCT01190124|OG000|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
11026976|NCT01190124|OG000|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
11026977|NCT01190124|OG000|Outcome|Total|Total number of patients studied
11026978|NCT01190124|EG000|Reported Event|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
11026979|NCT01190124|EG001|Reported Event|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
11026980|NCT01190124|EG002|Reported Event|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
11026981|NCT01190150|BG000|Baseline|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
11026982|NCT01190150|BG001|Baseline|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
11026983|NCT01190150|BG002|Baseline|Total|Total of all reporting groups
11026984|NCT01190150|FG000|Participant Flow|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
11026985|NCT01190150|FG001|Participant Flow|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
11026986|NCT01190150|OG000|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
11026987|NCT01190150|OG001|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
11026988|NCT01190150|EG000|Reported Event|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
11026989|NCT01190150|EG001|Reported Event|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
11026990|NCT01190176|BG000|Baseline|HPV-062 Study Subjects Group|HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
11026991|NCT01190176|FG000|Participant Flow|HPV-062 Study Subjects Group|HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
11026992|NCT01190176|OG000|Outcome|HPV-062 Study Subjects Group|HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
11026993|NCT01190176|EG000|Reported Event|HPV-062 Study Subjects Group|HPV-015 (NCT00294047) study subjects who had normal cervical cytology but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
11026994|NCT01190189|BG000|Baseline|Cervarix Group|Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
11026995|NCT01190189|FG000|Participant Flow|Cervarix Group|Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
11026996|NCT01190189|OG000|Outcome|Cervarix Group|Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
11026997|NCT01190189|EG000|Reported Event|Cervarix Group|Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
11026998|NCT01190215|BG000|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
11026999|NCT01190215|BG001|Baseline|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
11027000|NCT01190215|BG002|Baseline|Total|Total of all reporting groups
11027001|NCT01190215|FG000|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
11027002|NCT01190215|FG001|Participant Flow|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
11027003|NCT01190215|OG000|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
11027004|NCT01190215|OG001|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
11027005|NCT01190215|EG000|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
11027006|NCT01190215|EG001|Reported Event|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
11027007|NCT01190410|BG000|Baseline|Certolizumab Pegol: Low-dose Group (Weight Adjusted)|200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027008|NCT01190410|BG001|Baseline|Certolizumab Pegol: High-dose Group (Weight Adjusted)|400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027009|NCT01190410|BG002|Baseline|Total Title|
11027010|NCT01190410|FG000|Participant Flow|Certolizumab Pegol: Low-dose Group (Weight Adjusted)|200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027011|NCT01190410|FG001|Participant Flow|Certolizumab Pegol: High-dose Group (Weight Adjusted)|400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027012|NCT01190410|OG000|Outcome|Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)|200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027013|NCT01190410|OG001|Outcome|Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)|400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027014|NCT01190410|OG002|Outcome|Certolizumab Pegol: Re-Induction Group - (SS)|If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to < 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027015|NCT01190410|OG000|Outcome|Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (ITT)|200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to &lt; 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
11027016|NCT01190410|OG001|Outcome|Certolizumab Pegol: High-dose Group (Weight Adjusted) - (ITT)|400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to &lt; 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
11027017|NCT01190410|OG000|Outcome|Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (ITT)|200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
11027018|NCT01190410|OG001|Outcome|Certolizumab Pegol: High-dose Group (Weight Adjusted) - (ITT)|400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
11027019|NCT01190410|EG000|Reported Event|Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)|200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027020|NCT01190410|EG001|Reported Event|Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)|400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027021|NCT01190410|EG002|Reported Event|Certolizumab Pegol: Re-Induction Group - (SS)|If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to < 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
11027022|NCT01190436|BG000|Baseline|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
11027023|NCT01190436|FG000|Participant Flow|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
11027024|NCT01190436|OG000|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
11027025|NCT01190436|OG000|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
11027026|NCT01190436|EG000|Reported Event|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
11027027|NCT01190449|BG000|Baseline|Arm I (Low-dose Ofatumumab)|Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
11027028|NCT01190449|BG001|Baseline|Arm II (High-dose Ofatumumab)|Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
11027029|NCT01190449|BG002|Baseline|Total|Total of all reporting groups
11027030|NCT01190449|FG000|Participant Flow|Arm I (Low-dose Ofatumumab)|Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
11027031|NCT01190449|FG001|Participant Flow|Arm II (High-dose Ofatumumab)|Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
11027032|NCT01190449|OG000|Outcome|Arm I (Low-dose Ofatumumab)|Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
11027033|NCT01190449|OG001|Outcome|Arm II (High-dose Ofatumumab)|Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
11027034|NCT01190449|EG000|Reported Event|Arm I (Low-dose Ofatumumab)|Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
11027035|NCT01190449|EG001|Reported Event|Arm II (High-dose Ofatumumab)|Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
11027036|NCT01190475|BG000|Baseline|BGS649 High Dose|1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules
11027037|NCT01190475|BG001|Baseline|BGS649 Low Dose|1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
11027038|NCT01190475|BG002|Baseline|Placebo|1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
11027039|NCT01190475|BG003|Baseline|Total|Total of all reporting groups
11027040|NCT01190475|FG000|Participant Flow|BGS649 High Dose|1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules
11027041|NCT01190475|FG001|Participant Flow|BGS649 Low Dose|1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
11027042|NCT01190475|FG002|Participant Flow|Placebo|1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
11027043|NCT01190475|OG000|Outcome|BGS649 High Dose|BGS649
11027044|NCT01190475|OG001|Outcome|BGS649 Low Dose|BGS649
11027045|NCT01190475|OG002|Outcome|Placebo|Placebo
11027046|NCT01190475|OG000|Outcome|BGS649 High Dose|"1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.~Active treatment with a high dose of BGS649"
11027047|NCT01190475|OG001|Outcome|BGS649 Low Dose|"1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules~Active treatment with a low dose of BGS649"
11027048|NCT01190475|EG000|Reported Event|BGS649 High Dose|1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.
11027049|NCT01190475|EG001|Reported Event|BGS649 Low Dose|1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
11027050|NCT01190475|EG002|Reported Event|Placebo|1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
11027051|NCT01190514|BG000|Baseline|Entire Study Population|Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg*2 Fed (A); or DVS SR 50 mg Fed (B); or DVS SR 25 mg*2 Fasted (C); or DVS SR 50 mg Fasted (D).
11027052|NCT01190514|FG000|Participant Flow|DVS SR 25 mg*2 Fed (A) First|Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
11027053|NCT01190514|FG001|Participant Flow|DVS SR 50 mg Fed (B) First|DVS SR 50 mg tablet on Day 1 of study period in fed state.
11027054|NCT01190514|FG002|Participant Flow|DVS SR 25 mg*2 Fasted (C) First|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
11027055|NCT01190514|FG003|Participant Flow|DVS SR 50 mg Fasted (D) First|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
11027056|NCT01190514|OG000|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
11027057|NCT01190514|OG001|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
11027058|NCT01190514|OG002|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
11027059|NCT01190514|OG003|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
11027060|NCT01190514|EG000|Reported Event|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
11027061|NCT01190514|EG001|Reported Event|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
11027062|NCT01190514|EG002|Reported Event|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
11027063|NCT01190514|EG003|Reported Event|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
11027064|NCT01190527|BG000|Baseline|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
11027065|NCT01190527|FG000|Participant Flow|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
11027066|NCT01190527|OG000|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
11027067|NCT01190527|EG000|Reported Event|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
11027068|NCT01190566|BG000|Baseline|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
11027069|NCT01190566|BG001|Baseline|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
11027070|NCT01190566|BG002|Baseline|Total|Total of all reporting groups
11027071|NCT01190566|FG000|Participant Flow|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
11027072|NCT01190566|FG001|Participant Flow|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
11027073|NCT01190566|OG000|Outcome|Pathologic Response to Chemotherapy|Degree of pathologic response to the neoadjuvant chemotherapy
11027074|NCT01190566|OG000|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
11027075|NCT01190566|OG001|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
11027076|NCT01190566|EG000|Reported Event|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
11027077|NCT01190566|EG001|Reported Event|Non-pCR|the presence of invasive tumor cells after surgery
11027078|NCT01190813|BG000|Baseline|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
11027079|NCT01190813|BG001|Baseline|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
11027080|NCT01190813|BG002|Baseline|Total|Total of all reporting groups
11027081|NCT01190813|FG000|Participant Flow|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
11027082|NCT01190813|FG001|Participant Flow|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
11027083|NCT01190813|OG000|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
11027084|NCT01190813|OG001|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
11027085|NCT01190813|EG000|Reported Event|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
11027086|NCT01190813|EG001|Reported Event|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
11027087|NCT01190839|BG000|Baseline|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
11027088|NCT01190839|BG001|Baseline|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
11027089|NCT01190839|BG002|Baseline|Total|Total of all reporting groups
11027090|NCT01190839|FG000|Participant Flow|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
11027091|NCT01190839|FG001|Participant Flow|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
11027092|NCT01190839|OG000|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
11027093|NCT01190839|OG001|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
11027094|NCT01190839|EG000|Reported Event|Placebo|Participants treated with placebo through the final visit or through a protocol defined dose increase. If a participant had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
11027095|NCT01190839|EG001|Reported Event|Infliximab 5 mg/kg|Participants treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a participants had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
11027096|NCT01190839|EG002|Reported Event|First Placebo Then Infliximab 5 mg/kg|Participants had a protocol defined dose increase from Placebo to infliximab 5 mg/kg. Only safety results after start of infliximab were included in this group.
11027097|NCT01190839|EG003|Reported Event|First Infliximab 5 mg/kg Then Infliximab 10 mg/kg|Participants had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg. Only safety results after the dose increase were included in this group.
11027098|NCT01190865|BG000|Baseline|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
11027099|NCT01190865|FG000|Participant Flow|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
11027100|NCT01190865|OG000|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
11027101|NCT01190865|EG000|Reported Event|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
11027102|NCT01190878|BG000|Baseline|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
11027103|NCT01190878|BG001|Baseline|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
11027104|NCT01190878|BG002|Baseline|Xibrom BID|Xibrom™: Xibrom dosed BID
11027105|NCT01190878|BG003|Baseline|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
11027106|NCT01190878|BG004|Baseline|Total|Total of all reporting groups
11027107|NCT01190878|FG000|Participant Flow|ISV-303 BID|ISV-303: 0.075% bromfenac in DuraSite dosed BID
11027108|NCT01190878|FG001|Participant Flow|ISV-303 QD|ISV-303: 0.075% bromfenac in DuraSite dosed QD
11027109|NCT01190878|FG002|Participant Flow|Xibrom BID|Xibrom™: 0.09% bromfenac dosed BID
11027110|NCT01190878|FG003|Participant Flow|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle dosed BID
11027111|NCT01190878|OG000|Outcome|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
11027112|NCT01190878|OG001|Outcome|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
11027113|NCT01190878|OG002|Outcome|Xibrom BID|Xibrom™: Xibrom dosed BID
11027114|NCT01190878|OG003|Outcome|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
11027115|NCT01190878|EG000|Reported Event|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
11027116|NCT01190878|EG001|Reported Event|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
11027117|NCT01190878|EG002|Reported Event|Xibrom BID|Xibrom™: Xibrom dosed BID
11027118|NCT01190878|EG003|Reported Event|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
11027119|NCT01190891|BG000|Baseline|Manual Physical Therapy|Manual Physical Therapy: Same as arm description
11027120|NCT01190891|BG001|Baseline|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
11027121|NCT01190891|BG002|Baseline|Total|Total of all reporting groups
11027122|NCT01190891|FG000|Participant Flow|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
11027123|NCT01190891|FG001|Participant Flow|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
11027124|NCT01190891|OG000|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
11027125|NCT01190891|OG001|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
11027126|NCT01190891|EG000|Reported Event|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
11027127|NCT01190891|EG001|Reported Event|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
11027128|NCT01190930|BG000|Baseline|B-ALL|All B-ALL patients
11027129|NCT01190930|BG001|Baseline|B-LLy|All B-LLy patients
11027130|NCT01190930|BG002|Baseline|Total|Total of all reporting groups
11027131|NCT01190930|FG000|Participant Flow|B-ALL|All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate on days 8 and 29. Patients with DS also receive leucovorin calcium every 12 hours on days 10-11 and 21-32. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 [> 25% lymphoblasts] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.
11027132|NCT01190930|FG001|Participant Flow|B-LLy|Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
11027133|NCT01190930|FG002|Participant Flow|B-ALL Average Risk|Consolidation (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34
11027134|NCT01190930|FG003|Participant Flow|Standard Risk With Down Syndrome|Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
11027135|NCT01190930|FG004|Participant Flow|B-ALL Low Risk Arm I (LR-M)|Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1&4), d 57 (course 2&5), d29 (course 3&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. *Patients do not receive MTX PO on d w/ IT MTX.
11027136|NCT01190930|FG005|Participant Flow|B-ALL Low Risk Arm II (LR-C)|Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
11027137|NCT01190930|FG006|Participant Flow|B-ALL Average Risk-Arm A|Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1+P8:W8-84; and IT MTX d 1
11027138|NCT01190930|FG007|Participant Flow|B-ALL Average Risk-Arm B|Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1
11027139|NCT01190930|FG008|Participant Flow|B-ALL Average Risk-Arm C|Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11027140|NCT01190930|FG009|Participant Flow|B-ALL Average Risk-Arm D|Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11027141|NCT01190930|OG000|Outcome|B-ALL Average Risk: MTX 20 mg/m^2/Week Starting Dose|Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11027142|NCT01190930|OG001|Outcome|B-ALL Average Risk: MTX 40 mg/m^2/Week Starting Dose|Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11027143|NCT01190930|OG000|Outcome|B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks|Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11027144|NCT01190930|OG001|Outcome|B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks|Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11225834|NCT02370511|OG002|Outcome|Valve-in-Valve|"Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11027145|NCT01190930|OG000|Outcome|B-ALL Low Risk Arm I (LR-M)|Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1&4), d 57 (course 2&5), d29 (course 3&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. *Patients do not receive MTX PO on d w/ IT MTX.
11027146|NCT01190930|OG001|Outcome|B-ALL Low Risk Arm II (LR-C)|Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
11027147|NCT01190930|OG000|Outcome|Standard Risk With Down Syndrome|Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
11027148|NCT01190930|OG000|Outcome|B-LLy|Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
11027149|NCT01190930|OG000|Outcome|B-LLy|Induction: same trt as B-ALL Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
11027150|NCT01190930|OG000|Outcome|B-ALL Average Risk|Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11027151|NCT01190930|OG000|Outcome|B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks|"Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayedintensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int.~maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1"
11027152|NCT01190930|OG001|Outcome|B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks|"Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayedintensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int.~maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1"
11067083|NCT01395277|BG000|Baseline|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content . On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.~During the first visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the placebo trial (low flavanol group) will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
11027153|NCT01190930|EG000|Reported Event|B-ALL|All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate on days 8 and 29. Patients with DS also receive leucovorin calcium every 12 hours on days 10-11 and 21-32. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 [> 25% lymphoblasts] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.
11027154|NCT01190930|EG001|Reported Event|B-LLy|Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
11027155|NCT01190930|EG002|Reported Event|B-ALL Average Risk|Consolidation (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34
11027156|NCT01190930|EG003|Reported Event|Standard Risk With Down Syndrome|Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
11027157|NCT01190930|EG004|Reported Event|B-ALL Low Risk Arm I (LR-M)|Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1&4), d 57 (course 2&5), d29 (course 3&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. *Patients do not receive MTX PO on d w/ IT MTX.
11027158|NCT01190930|EG005|Reported Event|B-ALL Low Risk Arm II (LR-C)|Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
11027159|NCT01190930|EG006|Reported Event|B-ALL Average Risk-Arm A|Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1+P8:W8-84; and IT MTX d 1
11027160|NCT01190930|EG007|Reported Event|B-ALL Average Risk-Arm B|Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1
11027161|NCT01190930|EG008|Reported Event|B-ALL Average Risk-Arm C|Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11027162|NCT01190930|EG009|Reported Event|B-ALL Average Risk-Arm D|Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
11027163|NCT01191008|BG000|Baseline|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
11027164|NCT01191008|FG000|Participant Flow|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
11027165|NCT01191008|OG000|Outcome|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
11027166|NCT01191008|EG000|Reported Event|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
11027167|NCT01191086|BG000|Baseline|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
11027168|NCT01191086|FG000|Participant Flow|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
11027169|NCT01191086|OG000|Outcome|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
11027170|NCT01191086|EG000|Reported Event|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
11027171|NCT01191190|BG000|Baseline|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
11027172|NCT01191190|FG000|Participant Flow|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
11027173|NCT01191190|OG000|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
11027174|NCT01191190|EG000|Reported Event|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
11027175|NCT01191242|BG000|Baseline|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
11027176|NCT01191242|FG000|Participant Flow|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
11027177|NCT01191242|OG000|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
11027178|NCT01191242|EG000|Reported Event|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
11027179|NCT01191255|BG000|Baseline|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
11027180|NCT01191255|BG001|Baseline|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
11027181|NCT01191255|BG002|Baseline|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
11027182|NCT01191255|BG003|Baseline|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
11027183|NCT01191255|BG004|Baseline|Total|Total of all reporting groups
11027184|NCT01191255|FG000|Participant Flow|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
11027185|NCT01191255|FG001|Participant Flow|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
11027186|NCT01191255|FG002|Participant Flow|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
11027187|NCT01191255|FG003|Participant Flow|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
11027188|NCT01191255|OG000|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
11027189|NCT01191255|OG001|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
11027190|NCT01191255|OG002|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
11027191|NCT01191255|OG003|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
11027192|NCT01191255|EG000|Reported Event|KRX-0502 (SAP)|Safety Assessment Period (Week 1-52)
11027193|NCT01191255|EG001|Reported Event|Active Control (SAP)|Safety Assessment Period (Week 1-52)
11027194|NCT01191255|EG002|Reported Event|KRX-0502 (EAP)|Efficacy Assessment Period (Week 52-56)
11027195|NCT01191255|EG003|Reported Event|Placebo (EAP)|Efficacy Assessment Period (Week 52-56)
11027196|NCT01191268|BG000|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027197|NCT01191268|BG001|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027198|NCT01191268|BG002|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027199|NCT01191268|BG003|Baseline|Total|Total of all reporting groups
11027200|NCT01191268|FG000|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027201|NCT01191268|FG001|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027202|NCT01191268|FG002|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027203|NCT01191268|OG000|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027204|NCT01191268|OG001|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027205|NCT01191268|OG002|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027206|NCT01191268|OG000|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg , subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027207|NCT01191268|EG000|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027208|NCT01191268|EG001|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027209|NCT01191268|EG002|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
11027210|NCT01191320|BG000|Baseline|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
11027211|NCT01191320|BG001|Baseline|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
11027212|NCT01191320|BG002|Baseline|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
11027213|NCT01191320|BG003|Baseline|Total|Total of all reporting groups
11027214|NCT01191320|FG000|Participant Flow|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
11027215|NCT01191320|FG001|Participant Flow|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
11027216|NCT01191320|FG002|Participant Flow|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
11027217|NCT01191320|OG000|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
11027218|NCT01191320|OG001|Outcome|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
11027219|NCT01191320|OG002|Outcome|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
11027220|NCT01191320|EG000|Reported Event|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
11027221|NCT01191320|EG001|Reported Event|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
11027222|NCT01191320|EG002|Reported Event|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
11027223|NCT01191333|BG000|Baseline|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11027224|NCT01191333|BG001|Baseline|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
11027225|NCT01191333|BG002|Baseline|Total|Total of all reporting groups
11027226|NCT01191333|FG000|Participant Flow|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11027227|NCT01191333|FG001|Participant Flow|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
11027228|NCT01191333|OG000|Outcome|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11027229|NCT01191333|OG001|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
11027230|NCT01191333|EG000|Reported Event|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11027231|NCT01191333|EG001|Reported Event|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
11027232|NCT01191398|BG000|Baseline|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
11027233|NCT01191398|BG001|Baseline|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
11027234|NCT01191398|BG002|Baseline|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
11027235|NCT01191398|BG003|Baseline|Total|Total of all reporting groups
11027236|NCT01191398|FG000|Participant Flow|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
11027237|NCT01191398|FG001|Participant Flow|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
11027238|NCT01191398|FG002|Participant Flow|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
11027239|NCT01191398|OG000|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
11027240|NCT01191398|OG001|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
11027241|NCT01191398|OG002|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
11027242|NCT01191398|EG000|Reported Event|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
11027243|NCT01191398|EG001|Reported Event|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
11027244|NCT01191398|EG002|Reported Event|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
11027245|NCT01191411|BG000|Baseline|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
11027246|NCT01191411|BG001|Baseline|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
11027247|NCT01191411|BG002|Baseline|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
11027248|NCT01191411|BG003|Baseline|Total|Total of all reporting groups
11027249|NCT01191411|FG000|Participant Flow|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
11027250|NCT01191411|FG001|Participant Flow|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
11027251|NCT01191411|FG002|Participant Flow|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
11225835|NCT02370511|EG000|Reported Event|Native Mitral Valve With Severe MAC|"Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11027252|NCT01191411|OG000|Outcome|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
11027253|NCT01191411|OG001|Outcome|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
11027254|NCT01191411|OG002|Outcome|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
11027255|NCT01191411|EG000|Reported Event|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
11027256|NCT01191411|EG001|Reported Event|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
11027257|NCT01191411|EG002|Reported Event|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
11027258|NCT01191476|BG000|Baseline|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
10886762|NCT00496015|OG002|Outcome|Synflorix PRE Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
11027259|NCT01191476|BG001|Baseline|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
11027260|NCT01191476|BG002|Baseline|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
11027261|NCT01191476|BG003|Baseline|Total|Total of all reporting groups
11027262|NCT01191476|FG000|Participant Flow|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
11027263|NCT01191476|FG001|Participant Flow|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
11027264|NCT01191476|FG002|Participant Flow|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
11027265|NCT01191476|OG000|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
11027266|NCT01191476|OG001|Outcome|Propofol|IV Propofol for induction and maintenance of anesthesia
11027267|NCT01191476|OG002|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
11027268|NCT01191476|OG001|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
11027269|NCT01191476|OG002|Outcome|Propofol Induction and Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
11027270|NCT01191476|EG000|Reported Event|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
11027271|NCT01191476|EG001|Reported Event|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
11027272|NCT01191476|EG002|Reported Event|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
11027273|NCT01191541|BG000|Baseline|DNR+Ara-c|one group treated with DNR+Ara-C
11027274|NCT01191541|BG001|Baseline|DNR（ no Ara-C)|one group treated with DNR
11027275|NCT01191541|BG002|Baseline|Total|Total of all reporting groups
11027276|NCT01191541|FG000|Participant Flow|Daunorubicin(DNR)+Ara-c (Ara-C Group)|one group treated with daunorubicin(DNR)+Ara-C in consolidation
11027277|NCT01191541|FG001|Participant Flow|DNR (No Ara-c Group)|Only DNR was used in consolidation
11027278|NCT01191541|OG000|Outcome|DNR Group|the patients in this group were treated with DNR alone in consolidation
11027279|NCT01191541|OG001|Outcome|DNR+Ara-C Group|the patients in this group were treated with DNR +Ara-C in consolidation
11027280|NCT01191541|OG000|Outcome|DNR+Ara-c(Ara-C Group)|"patients in this group were treated with DNR+Ara-C in consolidation~DNR:: DNR：45mg/m2 d1-3~Ara-c: DNR+ARA-C：DNR：45mg/m2 d1-3;Ara-C :1g/m2 d1-3"
11027281|NCT01191541|OG001|Outcome|DNR(No Ara-C Group)|"patients in this group were treated with DNR alone in consolidation~DNR:: DNR：45mg/m2 d1-3"
11027282|NCT01191541|OG000|Outcome|DNR+Ara-c (Ara-C Group)|one group treated with DNR+Ara-C in consolidation
11027283|NCT01191541|OG001|Outcome|DNR (No Ara-c Group)|Only DNR was used in consolidation
11027284|NCT01191541|EG000|Reported Event|All the Patients at Presentation|Between May 2010 and December 2016, 65 consecutive paediatric (≤14 years of age) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.
11027285|NCT01191541|EG001|Reported Event|the Adverse Events Associated With ATRA|There were 65 patients were treated with ATRA and ATO in induction.
11027286|NCT01191541|EG002|Reported Event|the Adverse Events Associated With ATO|There were 65 patients were treated with ATRA and ATO in induction.
11027287|NCT01191541|EG003|Reported Event|Consolidation: IDA|There were 65 patients were treated with IDA in consolidation. .
11027288|NCT01191541|EG004|Reported Event|Consolidation: ATO|There were 65 patients were treated with ATO in consolidation.
11027289|NCT01191541|EG005|Reported Event|Consolidation: DNR (No Ara-c Group)|There were 35 patients were treated with DNR in consolidation.
11027290|NCT01191541|EG006|Reported Event|Consolidation: DNR+Ara-c (Ara-C Group)|There were 30 patients were treated with DNR+ARA-C in consolidation.
11027291|NCT01191541|EG007|Reported Event|Maintenance: ATRA+MTX+6-MP|There were 65 patients were treated with maintenance.
11027292|NCT01191723|BG000|Baseline|All Subjects|All subjects enrolled in the study.
11027293|NCT01191723|FG000|Participant Flow|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.~Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4."
11027294|NCT01191723|FG001|Participant Flow|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.~Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
11027295|NCT01191723|FG002|Participant Flow|Treatment B, Then A, Then C|"Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.~Treatment C = inhaler placebo and placebo capsules at Visit 4."
11027296|NCT01191723|FG003|Participant Flow|Treatment B, Then C, Then A|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
11027297|NCT01191723|FG004|Participant Flow|Treatment C, Then A, Then B|"Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.~Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
11027298|NCT01191723|FG005|Participant Flow|Treatment C, Then B, Then A|Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
11027299|NCT01191723|OG000|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
11027300|NCT01191723|OG001|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
11027301|NCT01191723|OG000|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
11027302|NCT01191723|OG002|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
11027303|NCT01191723|EG000|Reported Event|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules
11027304|NCT01191723|EG001|Reported Event|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules
11027305|NCT01191723|EG002|Reported Event|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet
11027306|NCT01191736|BG000|Baseline|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
11027307|NCT01191736|BG001|Baseline|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
11027308|NCT01191736|BG002|Baseline|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
11027309|NCT01191736|BG003|Baseline|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
11027310|NCT01191736|BG004|Baseline|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
11027311|NCT01191736|BG005|Baseline|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
11027312|NCT01191736|BG006|Baseline|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
11027313|NCT01191736|BG007|Baseline|Total|Total of all reporting groups
11027314|NCT01191736|FG000|Participant Flow|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
11027315|NCT01191736|FG001|Participant Flow|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
11027316|NCT01191736|FG002|Participant Flow|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
11027317|NCT01191736|FG003|Participant Flow|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
11027318|NCT01191736|FG004|Participant Flow|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
11027319|NCT01191736|FG005|Participant Flow|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
11027320|NCT01191736|FG006|Participant Flow|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
11027321|NCT01191736|OG000|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
11027322|NCT01191736|OG001|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
11027323|NCT01191736|OG002|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
11027324|NCT01191736|OG003|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
11027325|NCT01191736|OG004|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
11027326|NCT01191736|OG005|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
11027327|NCT01191736|OG006|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
11027328|NCT01191736|EG000|Reported Event|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
11027329|NCT01191736|EG001|Reported Event|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
11027330|NCT01191736|EG002|Reported Event|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
11027331|NCT01191736|EG003|Reported Event|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
11027332|NCT01191736|EG004|Reported Event|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
11027333|NCT01191736|EG005|Reported Event|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
11027334|NCT01191736|EG006|Reported Event|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
11027335|NCT01191749|BG000|Baseline|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
11027336|NCT01191749|FG000|Participant Flow|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
11027337|NCT01191749|OG000|Outcome|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
11027338|NCT01191749|EG000|Reported Event|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
11027339|NCT01191762|BG000|Baseline|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
11027340|NCT01191762|BG001|Baseline|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
11027341|NCT01191762|BG002|Baseline|Total|Total of all reporting groups
11027342|NCT01191762|FG000|Participant Flow|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
11027343|NCT01191762|FG001|Participant Flow|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
11027344|NCT01191762|OG000|Outcome|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
11027345|NCT01191762|OG001|Outcome|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
11027346|NCT01191762|EG000|Reported Event|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
11027347|NCT01191762|EG001|Reported Event|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
11027348|NCT01191788|BG000|Baseline|Group CBT|Clients received up to 16 sessions of group CBT for depression
11027349|NCT01191788|BG001|Baseline|Comparison|Treatment as Usual comparison condition
11027350|NCT01191788|BG002|Baseline|Total|Total of all reporting groups
11027351|NCT01191788|FG000|Participant Flow|Group CBT|Clients received up to 16 sessions of group CBT for depression
11027352|NCT01191788|FG001|Participant Flow|Comparison|Treatment as Usual comparison condition
11027353|NCT01191788|OG000|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
11027354|NCT01191788|OG001|Outcome|Comparison|Usual care
11027355|NCT01191788|OG001|Outcome|Comparison|Usual care.
11027356|NCT01191788|EG000|Reported Event|Group CBT|Clients received up to 16 sessions of group CBT for depression
11027357|NCT01191788|EG001|Reported Event|Comparison|Treatment as Usual comparison condition
11027358|NCT01191801|BG000|Baseline|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
11027359|NCT01191801|BG001|Baseline|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
11027360|NCT01191801|BG002|Baseline|Total|Total of all reporting groups
11027361|NCT01191801|FG000|Participant Flow|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
11027362|NCT01191801|FG001|Participant Flow|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
11027363|NCT01191801|OG000|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
11027364|NCT01191801|OG001|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
11027365|NCT01191801|EG000|Reported Event|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
11027366|NCT01191801|EG001|Reported Event|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
11027367|NCT01191827|BG000|Baseline|Risperidone|Patients with schizophrenia treated with risperidone
11027368|NCT01191827|BG001|Baseline|Clozapine|Patients with schizophrenia treated with clozapine
11027369|NCT01191827|BG002|Baseline|Total|Total of all reporting groups
11027370|NCT01191827|FG000|Participant Flow|Risperidone|Patients with schizophrenia treated with risperidone
11027371|NCT01191827|FG001|Participant Flow|Clozapine|Patients with schizophrenia treated with clozapine
11027372|NCT01191827|OG000|Outcome|Risperidone|Patients with schizophrenia treated with risperidone
11027373|NCT01191827|OG001|Outcome|Clozapine|Patients with schizophrenia treated with clozapine
11027374|NCT01191827|EG000|Reported Event|Risperidone|Patients with schizophrenia treated with risperidone
11027375|NCT01191827|EG001|Reported Event|Clozapine|Patients with schizophrenia treated with clozapine
11027376|NCT01191840|BG000|Baseline|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
11027377|NCT01191840|BG001|Baseline|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
11027378|NCT01191840|BG002|Baseline|Total|Total of all reporting groups
11027379|NCT01191840|FG000|Participant Flow|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
11027380|NCT01191840|FG001|Participant Flow|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
11027381|NCT01191840|OG000|Outcome|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
11027382|NCT01191840|OG001|Outcome|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
11027383|NCT01191840|EG000|Reported Event|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
11027384|NCT01191840|EG001|Reported Event|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
11027385|NCT01191944|BG000|Baseline|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
11027386|NCT01191944|BG001|Baseline|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
11027387|NCT01191944|BG002|Baseline|Total|Total of all reporting groups
11027388|NCT01191944|FG000|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
11027389|NCT01191944|FG001|Participant Flow|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
11027390|NCT01191944|OG000|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
11027391|NCT01191944|OG001|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
11027392|NCT01191944|EG000|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
11027393|NCT01191944|EG001|Reported Event|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
11027394|NCT01192022|BG000|Baseline|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027395|NCT01192022|BG001|Baseline|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027396|NCT01192022|BG002|Baseline|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027397|NCT01192022|BG003|Baseline|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027398|NCT01192022|BG004|Baseline|Total|Total of all reporting groups
11027399|NCT01192022|FG000|Participant Flow|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027400|NCT01192022|FG001|Participant Flow|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027401|NCT01192022|FG002|Participant Flow|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027402|NCT01192022|FG003|Participant Flow|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027403|NCT01192022|FG004|Participant Flow|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027404|NCT01192022|OG000|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027405|NCT01192022|OG001|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027406|NCT01192022|OG002|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027407|NCT01192022|OG003|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027408|NCT01192022|OG004|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027409|NCT01192022|EG000|Reported Event|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027410|NCT01192022|EG001|Reported Event|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027411|NCT01192022|EG002|Reported Event|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11027412|NCT01192022|EG003|Reported Event|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11148925|NCT01867710|EG001|Reported Event|Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11027413|NCT01192100|BG000|Baseline|All Study Participants|22 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in a random order, the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, & 20% fat); and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, & 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
11027414|NCT01192100|FG000|Participant Flow|Normal Protein > High Protein > Skip|6 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, & 20% fat); 2) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, & 20% fat); and 3) Breakfast Skipping. On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
11027415|NCT01192100|FG001|Participant Flow|Skip > Normal Protein > High Protein|4 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, & 20% fat) and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, & 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
11027416|NCT01192100|FG002|Participant Flow|Skip > High Protein > Normal Protein|3 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, & 20% fat), and 3) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, & 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
11027417|NCT01192100|FG003|Participant Flow|High Protein > Skip > Normal Protein|4 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, & 20% fat), 2) Breakfast Skipping and 3) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, & 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern
11027418|NCT01192100|FG004|Participant Flow|High Protein > Normal Protein > Skip|3 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, & 20% fat), 2) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, & 20% fat) and 3) Breakfast Skipping. On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
11027419|NCT01192100|FG005|Participant Flow|Normal Protein > Skip > High Protein|2 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, & 20% fat), 2) Breakfast Skipping and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, & 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
11027420|NCT01192100|OG000|Outcome|Breakfast Skipping|"Breakfast skipping serves as the baseline/control arm since the participants habitually skip breakfast (i.e., skip breakfast at least 5 times/week). Thus, during the week prior to and including the testing day, the participants will continue to skip breakfast each morning.~Breakfast Skipping: Participants will continue to skip breakfast each morning."
11027421|NCT01192100|OG001|Outcome|Normal Protein Breakfast Meals|"For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.~Normal Protein Breakfast Meals: Participants will consume normal protein breakfast meals each morning."
11027422|NCT01192100|OG002|Outcome|Protein-rich Breakfast Meals|"For 7 days, the participants will consume protein-rich breakfast meals each morning. These meals will consist of home-cooked foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 40% protein (35 g of protein), 40% CHO, and 20% fat.~Protein-rich Breakfast Meals: Participants will consume protein-rich breakfast meals each morning."
11027423|NCT01192100|OG000|Outcome|Activation After Skipping Breakfast is > After Consuming|To determine the effects of breakfast/no breakfast on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus [food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing]. Talairach coordinates for each region are presented for each row as (x;y;z) when activation was determined significant.
11027424|NCT01192100|OG001|Outcome|Activation After Normal-protein Breakfast is > After High|"For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.~Normal Protein Breakfast Meals: Participants will consume normal protein breakfast meals each morning."
11027425|NCT01192100|EG000|Reported Event|Breakfast Skipping|"Breakfast skipping serves as the baseline/control arm since the participants habitually skip breakfast (i.e., skip breakfast at least 5 times/week). Thus, during the week prior to and including the testing day, the participants will continue to skip breakfast each morning.~Breakfast Skipping: Participants will continue to skip breakfast each morning."
11027426|NCT01192100|EG001|Reported Event|Normal Protein Breakfast Meals|"For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.~Normal Protein Breakfast Meals: Participants will consume normal protein breakfast meals each morning."
11027427|NCT01192100|EG002|Reported Event|Protein-rich Breakfast Meals|"For 7 days, the participants will consume protein-rich breakfast meals each morning. These meals will consist of home-cooked foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 40% protein (35 g of protein), 40% CHO, and 20% fat.~Protein-rich Breakfast Meals: Participants will consume protein-rich breakfast meals each morning."
11027428|NCT01192126|BG000|Baseline|Overall Study|All eligible subjects
11027429|NCT01192126|FG000|Participant Flow|B & L Daily Disposable Lens, Then J & J Acuvue Moist|Bausch & Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson & Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
11027430|NCT01192126|FG001|Participant Flow|J & J Acuvue Moist, Then B & L Daily Disposable Lens|Johnson & Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch & Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
11027431|NCT01192126|OG000|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
11027432|NCT01192126|OG001|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
11027433|NCT01192126|EG000|Reported Event|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
11027434|NCT01192126|EG001|Reported Event|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
11027435|NCT01192139|BG000|Baseline|All Enrolled and Treated Participants|
11027436|NCT01192139|FG000|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
11027437|NCT01192139|FG001|Participant Flow|Treatment Sequence ACB|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
11027438|NCT01192139|FG002|Participant Flow|Treatment Sequence BAC|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
11027439|NCT01192139|FG003|Participant Flow|Treatment Sequence BCA|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
11027440|NCT01192139|FG004|Participant Flow|Treatment Sequence CAB|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
11027441|NCT01192139|FG005|Participant Flow|Treatment Sequence CBA|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
11027442|NCT01192139|OG000|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
11027443|NCT01192139|OG001|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
11027444|NCT01192139|OG002|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
11027445|NCT01192139|EG000|Reported Event|Treatment A|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
11027446|NCT01192139|EG001|Reported Event|Treatment C|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
11027447|NCT01192139|EG002|Reported Event|Treatment B|Fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
11027448|NCT01192152|BG000|Baseline|All Enrolled and Treated Participants|
11027449|NCT01192152|FG000|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions; Treatment B (period 2):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment C (period 3): FDC tablet (5 mg saxa + 1000 mg metformin XR), once daily for 4 days, under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2. There was no washout between Periods 2 and 3.
11027450|NCT01192152|FG001|Participant Flow|Treatment Sequence BA|Treatment B (period 1):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment A (period 2): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2.
11027451|NCT01192152|OG000|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
11027452|NCT01192152|OG001|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
11027453|NCT01192152|OG002|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
11027454|NCT01192152|EG000|Reported Event|Saxa 5mg + 2x500mg Metformin, Fed|5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
11027455|NCT01192152|EG001|Reported Event|Saxa 5mg/1000mg Metformin, Fed|Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
11027456|NCT01192152|EG002|Reported Event|Saxa 5mg/500mg Metformin, Fed 4 Days|FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
11027457|NCT01192178|BG000|Baseline|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
11027458|NCT01192178|BG001|Baseline|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
11027459|NCT01192178|BG002|Baseline|Total|Total of all reporting groups
11027460|NCT01192178|FG000|Participant Flow|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
11027461|NCT01192178|FG001|Participant Flow|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
11027462|NCT01192178|OG000|Outcome|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
11027463|NCT01192178|OG001|Outcome|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
11027464|NCT01192178|OG000|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
11027465|NCT01192178|OG001|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
11027466|NCT01192178|EG000|Reported Event|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
11027467|NCT01192178|EG001|Reported Event|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
11027468|NCT01192191|BG000|Baseline|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
11027469|NCT01192191|BG001|Baseline|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
11027470|NCT01192191|BG002|Baseline|Total|Total of all reporting groups
11027471|NCT01192191|FG000|Participant Flow|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
11027472|NCT01192191|FG001|Participant Flow|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
11027473|NCT01192191|OG000|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
11027474|NCT01192191|OG001|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
11027475|NCT01192191|EG000|Reported Event|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
11027476|NCT01192191|EG001|Reported Event|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
11027477|NCT01192204|BG000|Baseline|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
11027478|NCT01192204|BG001|Baseline|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
11027479|NCT01192204|BG002|Baseline|Total|Total of all reporting groups
11027480|NCT01192204|FG000|Participant Flow|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
11027481|NCT01192204|FG001|Participant Flow|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
11027482|NCT01192204|OG000|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
11027483|NCT01192204|OG001|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
11027484|NCT01192204|OG000|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months."
11027485|NCT01192204|EG000|Reported Event|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months~No adverse events"
11027486|NCT01192204|EG001|Reported Event|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months~No adverse events"
11027487|NCT01192282|BG000|Baseline|New Cases|Newly diagnosed cases of genital warts
11027488|NCT01192282|BG001|Baseline|Recurrent Cases|Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
11027489|NCT01192282|BG002|Baseline|Persistent Cases|The warts presence after completion of treatment
11027490|NCT01192282|BG003|Baseline|Total|Total of all reporting groups
11027491|NCT01192282|FG000|Participant Flow|Number of Participants|Participants with Genital Warts
11027492|NCT01192282|OG000|Outcome|HIV Positive|Number of participants with HIV Positive
11027493|NCT01192282|OG001|Outcome|HIV Negative|Number of participants with HIV Negative
11027494|NCT01192282|OG002|Outcome|HIV Unknown|Number of participants who refused HIV Testing
11027495|NCT01192282|OG000|Outcome|HPV DNA Positive|Participants with HPV DNA Positive
11027496|NCT01192282|OG001|Outcome|HPV DNA Negative|Participants with HPV DNA Negative
11027497|NCT01192282|OG000|Outcome|HIV Positive|Participants with HIV Positive
11027498|NCT01192282|OG001|Outcome|HIV Negative|Participants with HIV Negative
11027499|NCT01192282|OG002|Outcome|HIV Unknown|Participants who Refused HIV Testing
11027500|NCT01192282|EG000|Reported Event|HIV Positive|Participants with Genital Warts who were HIV Positive
11027501|NCT01192282|EG001|Reported Event|HIV Negative|Participants with Genital Warts who were HIV Negative
11027502|NCT01192282|EG002|Reported Event|HIV Unknown|Participants with Genital Warts whom HIV Status was Unknown
11027503|NCT01192295|BG000|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
11027504|NCT01192295|BG001|Baseline|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
11027505|NCT01192295|BG002|Baseline|Total|Total of all reporting groups
11027506|NCT01192295|FG000|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
11027507|NCT01192295|FG001|Participant Flow|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
11027508|NCT01192295|OG000|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
11027509|NCT01192295|OG001|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
11027510|NCT01192295|OG000|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
11027511|NCT01192295|OG000|Outcome|6 to 16 Years|Children 6 to 16 years of age
11027512|NCT01192295|EG000|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
11027513|NCT01192295|EG001|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
11027514|NCT01192347|BG000|Baseline|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
11027515|NCT01192347|FG000|Participant Flow|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
11027516|NCT01192347|OG000|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
11027517|NCT01192347|EG000|Reported Event|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
11027518|NCT01192399|BG000|Baseline|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
11027519|NCT01192399|FG000|Participant Flow|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
11027520|NCT01192399|OG000|Outcome|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
11027521|NCT01192399|EG000|Reported Event|Eculizumab|600 mg of eculizumab as intravenous (IV) infusion once a week for 4 doses, followed by 900 mg eculizumab IV infusion 1 week later for 1 dose, then 900 mg eculizumab IV infusion every 2 weeks for 4 doses.
11027522|NCT01192412|BG000|Baseline|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
11027523|NCT01192412|BG001|Baseline|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
11027524|NCT01192412|BG002|Baseline|Total|Total of all reporting groups
11027525|NCT01192412|FG000|Participant Flow|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
11027526|NCT01192412|FG001|Participant Flow|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
11027527|NCT01192412|OG000|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
11027528|NCT01192412|OG001|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
11027529|NCT01192412|EG000|Reported Event|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
11027530|NCT01192412|EG001|Reported Event|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
11066366|NCT01391832|FG000|Participant Flow|Sham rTMS|"Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)~Repetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.~Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been alte"
11066367|NCT01391832|FG001|Participant Flow|Active rTMS|"Active Repetitive Transcranial Magnet Stimulation treatment~Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex~Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.~Repetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the active mode. After motor threshold determination, the stimulator coil is positioned over the dorsolateral prefrontal cortex - D"
11066368|NCT01391832|OG000|Outcome|Sham rTMS|"Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)~The rTMS coil will be placed over the right prefrontal scalp region, simulating targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp.~Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered."
10886763|NCT00496015|OG003|Outcome|Synflorix POST Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
10886764|NCT00496015|OG004|Outcome|Mencevax + Infanrix Hexa Group|Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
10886765|NCT00496015|OG000|Outcome|Synflorix I Group|Subjects were vaccinated with 3 primary vaccination doses of Synflorix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
10886766|NCT00496015|OG002|Outcome|Mencevax + Infanrix Hexa Group|Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
10886767|NCT00496015|OG003|Outcome|Pooled Synflorix PRE and POST Group|Pooled group with subjects from both, Synflorix PRE Group and Synflorix POST Group, that received in this study (before and after the implementation of the protocol amendment) a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
10886768|NCT00496015|OG000|Outcome|Mencevax + Infanrix Hexa Group|Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
10886769|NCT00496015|OG000|Outcome|Synflorix I Group|Subjects were vaccinated with 3 primary vaccination doses of 10Pn vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
10886770|NCT00496015|OG000|Outcome|Pooled Synflorix Group|For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled.
10886771|NCT00496015|OG001|Outcome|Mencevax + Infanrix Hexa Group|Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
10886772|NCT00496015|OG001|Outcome|Pooled Synflorix Group|For carriage analyses the Synforix I, Synforix II, Synflorix PRE Group and Synflorix POST Group were pooled.
10886773|NCT00496015|EG000|Reported Event|Synflorix I Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
10886774|NCT00496015|EG001|Reported Event|Synflorix II Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
10886775|NCT00496015|EG002|Reported Event|Synflorix PRE Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
10886776|NCT00496015|EG003|Reported Event|Synflorix POST Group|Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
10886777|NCT00496015|EG004|Reported Event|Mencevax + Infanrix Hexa Group|Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
10886778|NCT00496054|BG000|Baseline|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
10886779|NCT00496054|FG000|Participant Flow|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
10886780|NCT00496054|OG000|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
10886781|NCT00496054|EG000|Reported Event|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
10886782|NCT00496080|BG000|Baseline|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
10886783|NCT00496080|FG000|Participant Flow|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
10886784|NCT00496080|OG000|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
10886785|NCT00496080|OG000|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
10886786|NCT00496080|EG000|Reported Event|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
10886787|NCT00496197|BG000|Baseline|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
10887343|NCT00499889|OG000|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
10886788|NCT00496197|FG000|Participant Flow|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
11027531|NCT01192516|BG000|Baseline|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
11027532|NCT01192516|BG001|Baseline|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
11027533|NCT01192516|BG002|Baseline|Arm 3|Usual care group
11027534|NCT01192516|BG003|Baseline|Total|Total of all reporting groups
11027535|NCT01192516|FG000|Participant Flow|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
11027536|NCT01192516|FG001|Participant Flow|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
11027537|NCT01192516|FG002|Participant Flow|Usual Care Group|Participants receiving usual care
11027538|NCT01192516|OG000|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
11027539|NCT01192516|OG001|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
11027540|NCT01192516|OG002|Outcome|Usual Care Group|Participants receiving usual care
11027541|NCT01192516|OG000|Outcome|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
11027542|NCT01192516|OG001|Outcome|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
11027543|NCT01192516|OG002|Outcome|Arm 3|Usual care group
11027544|NCT01192516|OG000|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
11027545|NCT01192516|EG000|Reported Event|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
11027546|NCT01192516|EG001|Reported Event|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
11027547|NCT01192516|EG002|Reported Event|Arm 3|Usual care group
11027548|NCT01192542|BG000|Baseline|All Subjects|All subjects who enrolled in the study.
11027549|NCT01192542|FG000|Participant Flow|Galyfilcon A Prototype Lens/Enfilcon A Lens|The galyfilcon A prototype contact lens worn daily for 6-8 days first then the enfilcon A contact lens worn daily for 6-8 days second.
11027550|NCT01192542|FG001|Participant Flow|Enfilcon A Lens/Galyfilcon A Prototype Lens|The enfilcon A contact lens worn daily for 6-8 days first then the galyfilcon A prototype contact lens worn daily for 6-8 days second.
11027551|NCT01192542|OG000|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
11027552|NCT01192542|OG001|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
11027553|NCT01192542|OG000|Outcome|Galyfilcon A Prototype Lens|Prototype silicon hydrogel contact lens.
11027554|NCT01192542|OG000|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel contact lens.
11027555|NCT01192542|OG001|Outcome|Enfilcon A Lens|Marketed silicone hydrogel contact lens.
11027556|NCT01192542|EG000|Reported Event|All Subjects|All subjects who exposed to the Investigation lenses.
11027557|NCT01192815|BG000|Baseline|Arm I|Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11027558|NCT01192815|FG000|Participant Flow|Arm I|Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11027559|NCT01192815|OG000|Outcome|Arm I|Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11027560|NCT01192815|EG000|Reported Event|Arm I|Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11027561|NCT01192828|BG000|Baseline|Taurine Intervention|Treatment with taurine for 4 1/2 days, two doses per day
11027562|NCT01192828|FG000|Participant Flow|Taurine Intervention|For safety reason, the first two subjects studies received low dose taurine therapy: 25 mg/kg body weight twice a day (maximum dose 1.5 grams). The next subjects received target high dose therapy: 75 mg/kg body weight twice a day (maximum dose of 5 grams).
11027563|NCT01192828|OG000|Outcome|Taurine Intervention Group|For safety reason, the first two subjects studies received low dose taurine therapy: 25 mg/kg body weight twice a day (maximum dose 1.5 grams). There after all received target dose therapy: 75 mg/kg body weight twice a day (maximum dose of 5 grams).
11027564|NCT01192828|OG000|Outcome|Taurine Intervention|Baseline value prior to taurine intervention.
11027565|NCT01192828|OG000|Outcome|Taurine Intervention Group|Baseline value prior to taurine intervention on day two of study.
11027566|NCT01192828|EG000|Reported Event|Taurine Intervention|Taurine Intervention
11027567|NCT01193010|BG000|Baseline|Control|"Surgery without computer-assisted planning.~distal radius osteotomy: In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy."
11027568|NCT01193010|BG001|Baseline|Computer-Assisted Surgical Planning|Computer-Assisted Surgical Planning: Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.
11027569|NCT01193010|BG002|Baseline|Total|Total of all reporting groups
11027570|NCT01193010|FG000|Participant Flow|Control|"Surgery without computer-assisted planning.~distal radius osteotomy: In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy."
11027571|NCT01193010|FG001|Participant Flow|Computer-Assisted Surgical Planning|Computer-Assisted Surgical Planning: Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.
11027572|NCT01193010|OG000|Outcome|Control|"Surgery without computer-assisted planning.~distal radius osteotomy: In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy."
11027573|NCT01193010|OG001|Outcome|Computer-Assisted Surgical Planning|Computer-Assisted Surgical Planning: Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.
11027574|NCT01193010|EG000|Reported Event|Control|"Surgery without computer-assisted planning.~distal radius osteotomy: In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy."
11027575|NCT01193010|EG001|Reported Event|Computer-Assisted Surgical Planning|Computer-Assisted Surgical Planning: Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.
11027576|NCT01193049|BG000|Baseline|All Participants|All randomized participants
11027577|NCT01193049|FG000|Participant Flow|Prednisone, Then Placebo|Prednisone in the first double blind treatment period and placebo in the second double blind treatment period
11027578|NCT01193049|FG001|Participant Flow|Placebo, Then Prednisone|Placebo in the first double blind treatment period and prednisone in the second double blind treatment period
11027579|NCT01193049|OG000|Outcome|Prednisone|All participants who received at least one dose of prednisone
11027580|NCT01193049|OG001|Outcome|Placebo|All participants who received at least one dose of placebo
11027581|NCT01193049|EG000|Reported Event|Prednisone|All participants who received at least one dose of prednisone
11027582|NCT01193049|EG001|Reported Event|Placebo|All participants who received at least one dose of placebo
11027583|NCT01193101|BG000|Baseline|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
11027584|NCT01193101|BG001|Baseline|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
11027585|NCT01193101|BG002|Baseline|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
11027586|NCT01193101|BG003|Baseline|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
11027587|NCT01193101|BG004|Baseline|Total|Total of all reporting groups
11027588|NCT01193101|FG000|Participant Flow|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
11027589|NCT01193101|FG001|Participant Flow|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
11027590|NCT01193101|FG002|Participant Flow|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
11027591|NCT01193101|FG003|Participant Flow|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
11027592|NCT01193101|OG000|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
11027593|NCT01193101|OG001|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
11027594|NCT01193101|OG002|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
11027595|NCT01193101|OG003|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
11027596|NCT01193101|EG000|Reported Event|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
11027597|NCT01193101|EG001|Reported Event|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
11027598|NCT01193101|EG002|Reported Event|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
11027599|NCT01193101|EG003|Reported Event|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
11027600|NCT01193114|BG000|Baseline|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
11027601|NCT01193114|BG001|Baseline|Treatment as Usual|The Mothers were offered services provided through the family shelter.
11027602|NCT01193114|BG002|Baseline|Total|Total of all reporting groups
11027603|NCT01193114|FG000|Participant Flow|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
11027604|NCT01193114|FG001|Participant Flow|Treatment as Usual|The Mothers were offered services provided through the family shelter.
11027605|NCT01193114|OG000|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
11027606|NCT01193114|OG001|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
11027607|NCT01193114|EG000|Reported Event|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
11027608|NCT01193114|EG001|Reported Event|Treatment as Usual|The Mothers were offered services provided through the family shelter.
11027609|NCT01193127|BG000|Baseline|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
11027610|NCT01193127|BG001|Baseline|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
11027611|NCT01193127|BG002|Baseline|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
11027612|NCT01193127|BG003|Baseline|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
11027613|NCT01193127|BG004|Baseline|Total|Total of all reporting groups
11027614|NCT01193127|FG000|Participant Flow|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
11027615|NCT01193127|FG001|Participant Flow|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
11027616|NCT01193127|FG002|Participant Flow|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
11027617|NCT01193127|FG003|Participant Flow|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
11027618|NCT01193127|OG000|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
11027619|NCT01193127|OG001|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
11027620|NCT01193127|OG002|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
11027621|NCT01193127|OG003|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
11027622|NCT01193127|OG000|Outcome|Solution|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
11027623|NCT01193127|OG000|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution~Balanced Salt Solution (BSS) Solution"
11027624|NCT01193127|EG000|Reported Event|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
11027625|NCT01193127|EG001|Reported Event|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
11027626|NCT01193127|EG002|Reported Event|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
11027627|NCT01193127|EG003|Reported Event|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
11027628|NCT01193153|BG000|Baseline|Entire Study Population|Included all participants who received at least 1 dose of paliperidone palmitate in open-label lead in period.
11027629|NCT01193153|FG000|Participant Flow|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. DB Relapse prevention period (15 months): Same dose as Day 92 once every 4 weeks until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
11027630|NCT01193153|FG001|Participant Flow|Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.
11027631|NCT01193153|OG000|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
11027632|NCT01193153|OG001|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
11027633|NCT01193153|OG000|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
11027634|NCT01193153|OG001|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
11027635|NCT01193153|EG000|Reported Event|Open Label - Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period.
11027636|NCT01193153|EG001|Reported Event|Double Blind - Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
11027637|NCT01193153|EG002|Reported Event|Double Blind - Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants during DB relapse prevention period.
11027638|NCT01193218|BG000|Baseline|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
11027639|NCT01193218|BG001|Baseline|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
11027640|NCT01193218|BG002|Baseline|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
11027641|NCT01193218|BG003|Baseline|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
11027642|NCT01193218|BG004|Baseline|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
11027643|NCT01193218|BG005|Baseline|Total|Total of all reporting groups
11027644|NCT01193218|FG000|Participant Flow|Placebo/Empa 10mg|It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period
11027645|NCT01193218|FG001|Participant Flow|Placebo/Empa 25 mg|It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period
11027646|NCT01193218|FG002|Participant Flow|Empa 5mg/10mg|It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
11027647|NCT01193218|FG003|Participant Flow|Empa 5 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
11027648|NCT01193218|FG004|Participant Flow|Empa 10mg|Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
11027649|NCT01193218|FG005|Participant Flow|Empa 25mg|Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
11027650|NCT01193218|FG006|Participant Flow|Empa 50mg\10mg|It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period
11027651|NCT01193218|FG007|Participant Flow|Empa 50 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
11027652|NCT01193218|OG000|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
11027653|NCT01193218|OG001|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
11027654|NCT01193218|OG002|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
11027655|NCT01193218|OG003|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
11027656|NCT01193218|OG004|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
11027657|NCT01193218|EG000|Reported Event|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
11027658|NCT01193218|EG001|Reported Event|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
11027659|NCT01193218|EG002|Reported Event|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
11027660|NCT01193218|EG003|Reported Event|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
11027661|NCT01193218|EG004|Reported Event|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
11027662|NCT01193218|EG005|Reported Event|Empa 10mg (Randomized, 52 Week)|Patients randomized to empagliflozin 10mg once daily for 52 weeks
11027663|NCT01193218|EG006|Reported Event|Empa 25mg (Randomized, 52 Week)|Patients randomized to empagliflozin 25 mg once daily for 52 weeks
11027664|NCT01193218|EG007|Reported Event|Empa 10mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 10 mg once daily for 52-week treatment
11027665|NCT01193218|EG008|Reported Event|Empa 25mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 25 mg once daily for 52-week treatment
11027666|NCT01193244|BG000|Baseline|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
11027667|NCT01193244|BG001|Baseline|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
11027668|NCT01193244|BG002|Baseline|Total|Total of all reporting groups
11027669|NCT01193244|FG000|Participant Flow|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
10886789|NCT00496197|OG000|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
10886790|NCT00496197|EG000|Reported Event|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
10886791|NCT00496262|BG000|Baseline|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
10886792|NCT00496262|FG000|Participant Flow|Human Fibrinogen Concentrate|All enrolled subjects received a single IV infusion of 70 mg/kg body weight of human fibrinogen concentrate.
10886793|NCT00496262|OG000|Outcome|Pre-infusion|≤ 2 hours before start of infusion
10886794|NCT00496262|OG001|Outcome|1 Hour Post-infusion|1 hour after end of infusion
10886795|NCT00496262|OG000|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
10886796|NCT00496262|EG000|Reported Event|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
10886797|NCT00496340|BG000|Baseline|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
10886798|NCT00496340|FG000|Participant Flow|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total area under curve (AUC) of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
10886799|NCT00496340|OG000|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
10886800|NCT00496340|EG000|Reported Event|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
10886801|NCT00496366|BG000|Baseline|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
10886802|NCT00496366|FG000|Participant Flow|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
11027670|NCT01193244|FG001|Participant Flow|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
11027671|NCT01193244|OG000|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
10886803|NCT00496366|OG000|Outcome|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
10886804|NCT00496366|EG000|Reported Event|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
10886805|NCT00496379|BG000|Baseline|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
10886806|NCT00496379|FG000|Participant Flow|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
10886807|NCT00496379|OG000|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
10886808|NCT00496379|EG000|Reported Event|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
10886809|NCT00496470|BG000|Baseline|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
10886810|NCT00496470|BG001|Baseline|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
10886811|NCT00496470|BG002|Baseline|Total|Total of all reporting groups
10886812|NCT00496470|FG000|Participant Flow|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
10886813|NCT00496470|FG001|Participant Flow|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
10886814|NCT00496470|OG000|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
10886815|NCT00496470|OG001|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
10886816|NCT00496470|EG000|Reported Event|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
10886817|NCT00496470|EG001|Reported Event|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
10886818|NCT00496483|BG000|Baseline|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
10886819|NCT00496483|FG000|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.~On Day 22 patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.~LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL."
10886820|NCT00496483|OG000|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
10886821|NCT00496483|OG000|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
10886822|NCT00496483|OG000|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
11225836|NCT02370511|EG001|Reported Event|Valve-in-Ring|"Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
10886823|NCT00496483|EG000|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.~60 patients were enrolled into the study, but only 51 were dosed with LCP-Tacro."
10886824|NCT00496483|EG001|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.~60 patients were entrolled into the study and one withdrew consent right after screening. Therefore 59 patients are inlcuded in the ITT safety set."
10886825|NCT00496587|BG000|Baseline|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
10886826|NCT00496587|FG000|Participant Flow|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
10886827|NCT00496587|OG000|Outcome|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
10886828|NCT00496587|EG000|Reported Event|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
10886829|NCT00496626|BG000|Baseline|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886830|NCT00496626|BG001|Baseline|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886831|NCT00496626|BG002|Baseline|Total|Total of all reporting groups
10886832|NCT00496626|FG000|Participant Flow|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
11027672|NCT01193244|OG001|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
11027673|NCT01193244|EG000|Reported Event|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
11027674|NCT01193244|EG001|Reported Event|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
11027675|NCT01193257|BG000|Baseline|Placebo + Prednisone|Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
11027676|NCT01193257|BG001|Baseline|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
11027677|NCT01193257|BG002|Baseline|Total|Total of all reporting groups
11027678|NCT01193257|FG000|Participant Flow|Placebo + Prednisone|Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
11027679|NCT01193257|FG001|Participant Flow|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
11027680|NCT01193257|OG000|Outcome|Placebo + Prednisone|Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
11027681|NCT01193257|OG001|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
11027682|NCT01193257|EG000|Reported Event|Placebo + Prednisone|Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
11027683|NCT01193257|EG001|Reported Event|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.
11027684|NCT01193283|BG000|Baseline|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
11027685|NCT01193283|FG000|Participant Flow|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
11027686|NCT01193283|OG000|Outcome|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
11027687|NCT01193283|EG000|Reported Event|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
11027688|NCT01193335|BG000|Baseline|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
11027689|NCT01193335|BG001|Baseline|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027690|NCT01193335|BG002|Baseline|Total|Total of all reporting groups
11027691|NCT01193335|FG000|Participant Flow|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
11027692|NCT01193335|FG001|Participant Flow|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027693|NCT01193335|OG000|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
11027694|NCT01193335|OG001|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027695|NCT01193335|OG000|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
11027696|NCT01193335|OG000|Outcome|13vPnC Group 1A|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027697|NCT01193335|OG001|Outcome|13vPnC Group 1B|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027698|NCT01193335|OG002|Outcome|13vPnC Group 1C|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027699|NCT01193335|OG000|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027700|NCT01193335|OG001|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027701|NCT01193335|OG002|Outcome|13vPnC (Group 1C)|Preterm infant participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027702|NCT01193335|OG002|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
11027703|NCT01193335|EG000|Reported Event|13vPnC Group 1 (Preterm Infant) - Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
11027704|NCT01193335|EG001|Reported Event|13vPnC Group 2 (Term Infant) - Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
11027705|NCT01193335|EG002|Reported Event|13vPnC Group 1 (Preterm Infant) - After Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
11027706|NCT01193335|EG003|Reported Event|13vPnC Group 2 (Term Infant) - After Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
11027707|NCT01193335|EG004|Reported Event|13vPnC Group 1 (Preterm Infant) - Toddler Dose|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
11027708|NCT01193335|EG005|Reported Event|13vPnC Group 2 (Term Infant) - Toddler Dose|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
11027709|NCT01193335|EG006|Reported Event|13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
11027710|NCT01193335|EG007|Reported Event|13vPnC Group 2 (Term Infant) - 1 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
11027711|NCT01193335|EG008|Reported Event|13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
11027712|NCT01193335|EG009|Reported Event|13vPnC Group 2 (Term Infant) - 2 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
11027713|NCT01193348|BG000|Baseline|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
11027714|NCT01193348|FG000|Participant Flow|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
11027715|NCT01193348|OG000|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
10886833|NCT00496626|FG001|Participant Flow|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886834|NCT00496626|OG000|Outcome|Vaccine (Gardasil®) Group (Day 1)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886835|NCT00496626|OG001|Outcome|Placebo Group (Day 1)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886836|NCT00496626|OG002|Outcome|Vaccine (Gardasil®) Group (Month 7)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886837|NCT00496626|OG003|Outcome|Placebo Group (Month 7)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886838|NCT00496626|OG000|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886839|NCT00496626|OG001|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886840|NCT00496626|EG000|Reported Event|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886841|NCT00496626|EG001|Reported Event|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
10886842|NCT00496769|BG000|Baseline|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
10886843|NCT00496769|BG001|Baseline|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
10886844|NCT00496769|BG002|Baseline|Total|Total of all reporting groups
10886845|NCT00496769|FG000|Participant Flow|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
10886846|NCT00496769|FG001|Participant Flow|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
10886847|NCT00496769|FG002|Participant Flow|Open Label Apixaban|Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
10886848|NCT00496769|OG000|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
10886849|NCT00496769|OG001|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
10886850|NCT00496769|OG000|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|"Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.~Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban."
10886851|NCT00496769|OG001|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|"Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion~Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban."
10886852|NCT00496769|EG000|Reported Event|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
10886853|NCT00496769|EG001|Reported Event|Acetylsalicylic Acid, 81-324 mg Once Daily|"Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion~Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban."
10886854|NCT00496769|EG002|Reported Event|Open Label Apixaban|Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
10886855|NCT00496808|BG000|Baseline|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
10886856|NCT00496808|FG000|Participant Flow|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
10886857|NCT00496808|OG000|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
10886858|NCT00496808|EG000|Reported Event|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
10886859|NCT00496860|BG000|Baseline|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
10886860|NCT00496860|BG001|Baseline|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
10886861|NCT00496860|BG002|Baseline|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
10886862|NCT00496860|BG003|Baseline|Total|Total of all reporting groups
11027716|NCT01193348|OG000|Outcome|Eculizumab. Min and Max Blood Concentration|5 - <10kg weight cohort
11027717|NCT01193348|OG000|Outcome|Eculizumab. Min and Max Blood Concentration|10 - <20kg weight cohort
11027718|NCT01193348|OG000|Outcome|Eculizumab. Min and Max Blood Concentration|20 - <30kg weight cohort
11027719|NCT01193348|OG000|Outcome|Eculizumab. Min and Max Blood Concentration|30 - <40kg weight cohort
11027720|NCT01193348|OG000|Outcome|Eculizumab. Min and Max Blood Concentration|≥40kg weight cohort
11027721|NCT01193348|EG000|Reported Event|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
11027722|NCT01193517|BG000|Baseline|Phase I: Starting Dose|"Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)~Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2."
11027723|NCT01193517|BG001|Baseline|Phase I: Highest Dose Level|Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
11027724|NCT01193517|BG002|Baseline|Phase II|"MTD of Azacitidine + CAPOX~Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2."
11027725|NCT01193517|BG003|Baseline|Total|Total of all reporting groups
11027726|NCT01193517|FG000|Participant Flow|Phase I: Starting Dose|"Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)~Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2."
10886863|NCT00496860|FG000|Participant Flow|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
11027727|NCT01193517|FG001|Participant Flow|Phase I: Highest Dose Level|Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
11027728|NCT01193517|FG002|Participant Flow|Phase II|"MTD of Azacitidine + CAPOX~Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2."
11027729|NCT01193517|OG000|Outcome|Azacitidine+CAPOX (Capecitabine, Oxaliplatin)|Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
11027730|NCT01193517|OG000|Outcome|Phase I: Starting Dose|"Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)~Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2."
10886864|NCT00496860|FG001|Participant Flow|ALT-801 0.040 mg/kg/ Dose|0.040 mg/kg/dose of ALT-801
11027731|NCT01193517|OG001|Outcome|Phase I: Highest Dose Level|Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
11027732|NCT01193517|OG002|Outcome|Phase II|"MTD of Azacitidine + CAPOX~Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2."
11027733|NCT01193517|EG000|Reported Event|Phase I: Starting Dose|"Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)~Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2."
11027734|NCT01193517|EG001|Reported Event|Phase I: Highest Dose Level|Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
11027735|NCT01193517|EG002|Reported Event|Phase II|"MTD of Azacitidine + CAPOX~Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2."
11027736|NCT01193582|BG000|Baseline|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
11027737|NCT01193582|BG001|Baseline|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
11027738|NCT01193582|BG002|Baseline|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
11027739|NCT01193582|BG003|Baseline|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
11027740|NCT01193582|BG004|Baseline|Total|Total of all reporting groups
11027741|NCT01193582|FG000|Participant Flow|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
11027742|NCT01193582|FG001|Participant Flow|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
11027743|NCT01193582|FG002|Participant Flow|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
11027744|NCT01193582|FG003|Participant Flow|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
11027745|NCT01193582|OG000|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
11027746|NCT01193582|OG001|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
11027747|NCT01193582|OG002|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
11027748|NCT01193582|OG003|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
11027749|NCT01193582|OG000|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
11027750|NCT01193582|OG000|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
11027751|NCT01193582|EG000|Reported Event|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
11027752|NCT01193582|EG001|Reported Event|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
11027753|NCT01193582|EG002|Reported Event|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
11027754|NCT01193582|EG003|Reported Event|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
11027755|NCT01193608|BG000|Baseline|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027756|NCT01193608|BG001|Baseline|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027757|NCT01193608|BG002|Baseline|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027758|NCT01193608|BG003|Baseline|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027759|NCT01193608|BG004|Baseline|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027760|NCT01193608|BG005|Baseline|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
11027761|NCT01193608|BG006|Baseline|Total|Total of all reporting groups
11027762|NCT01193608|FG000|Participant Flow|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 milligram/kilogram (mg/kg) 1-hour intravenous (IV) infusion (infusion of AAB-003 and 20 milliliter (mL) normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
11027763|NCT01193608|FG001|Participant Flow|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
11027764|NCT01193608|FG002|Participant Flow|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
11027765|NCT01193608|FG003|Participant Flow|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
11027766|NCT01193608|FG004|Participant Flow|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
11027767|NCT01193608|FG005|Participant Flow|Placebo|Participants received placebo matched to AAB-003 1-hour IV infusion (infusion of placebo matched to AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
11027768|NCT01193608|OG000|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027769|NCT01193608|OG001|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027770|NCT01193608|OG002|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027771|NCT01193608|OG003|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027772|NCT01193608|OG004|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027773|NCT01193608|OG005|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
11027774|NCT01193608|OG000|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027775|NCT01193608|OG001|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027776|NCT01193608|OG002|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027777|NCT01193608|OG000|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027778|NCT01193608|OG001|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
11027779|NCT01193608|EG000|Reported Event|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027780|NCT01193608|EG001|Reported Event|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027781|NCT01193608|EG002|Reported Event|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027782|NCT01193608|EG003|Reported Event|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027783|NCT01193608|EG004|Reported Event|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
11027784|NCT01193608|EG005|Reported Event|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
11027785|NCT01193660|BG000|Baseline|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
11027786|NCT01193660|BG001|Baseline|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
11027787|NCT01193660|BG002|Baseline|Only Rehabilitation|Active rehabilitation
11027788|NCT01193660|BG003|Baseline|Total|Total of all reporting groups
11027789|NCT01193660|FG000|Participant Flow|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
11027790|NCT01193660|FG001|Participant Flow|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
11027791|NCT01193660|FG002|Participant Flow|Only Rehabilitation|Active rehabilitation
11027792|NCT01193660|OG000|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
11027793|NCT01193660|OG001|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
11027794|NCT01193660|OG002|Outcome|Only Rehabilitation|Active rehabilitation
11027795|NCT01193660|EG000|Reported Event|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
11027796|NCT01193660|EG001|Reported Event|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
11027797|NCT01193660|EG002|Reported Event|Only Rehabilitation|Active rehabilitation
11027798|NCT01193686|BG000|Baseline|Veteran Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabiliation were recruited for training as peer mentors.
11027799|NCT01193686|BG001|Baseline|Recipients of Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and were initiating rehabilitation therapies.
11027800|NCT01193686|BG002|Baseline|Total|Total of all reporting groups
11027801|NCT01193686|FG000|Participant Flow|Veteran Peer Visitors|Of the 15 (52%) PV who enrolled in the study and completed the baseline assessment, 4 (27%) withdrew prior to PV training due to moving out of state (3) or schedule limitations (n=1). One was removed from the study by investigators due to discovery of invalid reporting.
11027802|NCT01193686|FG001|Participant Flow|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
11027803|NCT01193686|OG000|Outcome|Veteran Peer Visitors|
11027804|NCT01193686|OG001|Outcome|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
11027805|NCT01193686|OG001|Outcome|Recipients of PV|
11027806|NCT01193686|EG000|Reported Event|Veteran Peer Visitors|Veteran Peer Visitors (VPV) who participated in a 2-day training program and then provided at 1-5 visits to at least 2 recipients. All Peer Visitors had served in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabilitation.
11027807|NCT01193686|EG001|Reported Event|Recipients of Veteran Peer Visitation|Veterans of Operation Enduring Freedom or Operation Iraqi Freedom who sustained polytrauma (i.e., mutiple systems involved) injuries.
11027808|NCT01193868|BG000|Baseline|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
11027809|NCT01193868|FG000|Participant Flow|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
11027810|NCT01193868|OG000|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
11027811|NCT01193868|EG000|Reported Event|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
11027812|NCT01193907|BG000|Baseline|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
11027813|NCT01193907|BG001|Baseline|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
11027814|NCT01193907|BG002|Baseline|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
11027815|NCT01193907|BG003|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
11027816|NCT01193907|BG004|Baseline|Total|Total of all reporting groups
11027817|NCT01193907|FG000|Participant Flow|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
11027818|NCT01193907|FG001|Participant Flow|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
11027819|NCT01193907|FG002|Participant Flow|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
11027820|NCT01193907|FG003|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
11027821|NCT01193907|OG000|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
11027822|NCT01193907|OG001|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
11027823|NCT01193907|OG002|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
11027824|NCT01193907|OG003|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
11027825|NCT01193907|EG000|Reported Event|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
11027826|NCT01193907|EG001|Reported Event|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
11027827|NCT01193907|EG002|Reported Event|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
11027828|NCT01193907|EG003|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
11027829|NCT01193920|BG000|Baseline|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
10886865|NCT00496860|FG002|Participant Flow|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
10886866|NCT00496860|OG000|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
10886867|NCT00496860|OG001|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
10886868|NCT00496860|OG002|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
10886869|NCT00496860|EG000|Reported Event|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
10886870|NCT00496860|EG001|Reported Event|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
10886871|NCT00496860|EG002|Reported Event|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
10886872|NCT00496873|BG000|Baseline|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
10886873|NCT00496873|FG000|Participant Flow|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
10886874|NCT00496873|OG000|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
10886875|NCT00496873|EG000|Reported Event|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
10886876|NCT00496964|BG000|Baseline|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
10886877|NCT00496964|BG001|Baseline|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
10886878|NCT00496964|BG002|Baseline|Total|Total of all reporting groups
10886879|NCT00496964|FG000|Participant Flow|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
10886880|NCT00496964|FG001|Participant Flow|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
10886881|NCT00496964|OG000|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
10886882|NCT00496964|OG001|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
10886883|NCT00496964|OG000|Outcome|Botulinum Toxin A Injection + Exercise|"Subjects in this group received an Injection of Botulinum toxin A in the vastus lateralis of the study limb plus exercise program~Subjects received a single injection of 100 ml of Botulinum toxin A (Botulinum toxin type A) into the vastus lateralis muscle of the involved limb near the motor point followed by instruction in a home exercise program for knee and hip musculature that Exercises were performed for 12 weeks, with the number or repetitions and sets determined and progressed by a physical therapist based on reports of knee pain."
10886884|NCT00496964|OG001|Outcome|Placebo Injection + Exercise|"Placebo injection + exercise~Placebo: Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome focusing on the knee & hip."
10886885|NCT00496964|EG000|Reported Event|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
10886886|NCT00496964|EG001|Reported Event|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
10886887|NCT00497055|BG000|Baseline|Aripiprazole|aripiprazole daily for 3 months
10886888|NCT00497055|BG001|Baseline|Placebo|placebo daily for 3 months
10886889|NCT00497055|BG002|Baseline|Total|Total of all reporting groups
10886890|NCT00497055|FG000|Participant Flow|Aripiprazole|Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
10886891|NCT00497055|FG001|Participant Flow|Placebo|Placebo (for Aripiprazole) 5mg daily for week one. Placebo (for Aripiprazole) 10mg daily for week two. Placebo (for Aripiprazole) 20mg daily for weeks three through twelve.
10886892|NCT00497055|OG000|Outcome|Aripiprazole|aripiprazole daily for 3 months
10886893|NCT00497055|OG001|Outcome|Placebo|placebo daily for 3 months
10886894|NCT00497055|EG000|Reported Event|Aripiprazole|aripiprazole daily for 3 months
10886895|NCT00497055|EG001|Reported Event|Placebo|placebo daily for 3 months
10886896|NCT00497081|BG000|Baseline|Active Comparator:|mirtazapine 30 mg daily for 3 months
10886897|NCT00497081|BG001|Baseline|Placebo Comparator:|placebo 30 mg daily for 3 months
10886898|NCT00497081|BG002|Baseline|Total|Total of all reporting groups
10886899|NCT00497081|FG000|Participant Flow|Active Comparator:|mirtazapine 30 mg daily for 3 months
10886900|NCT00497081|FG001|Participant Flow|Placebo Comparator:|placebo 30 mg daily for 3 months
10886901|NCT00497081|OG000|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
10886902|NCT00497081|OG001|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
10886903|NCT00497081|EG000|Reported Event|Active Comparator:|mirtazapine 30 mg daily for 3 months
10886904|NCT00497081|EG001|Reported Event|Placebo Comparator:|placebo 30 mg daily for 3 months
10886905|NCT00497146|BG000|Baseline|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
10886906|NCT00497146|BG001|Baseline|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
10886907|NCT00497146|BG002|Baseline|Total|Total of all reporting groups
10886908|NCT00497146|FG000|Participant Flow|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
10886909|NCT00497146|FG001|Participant Flow|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
11027830|NCT01193920|BG001|Baseline|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
11027831|NCT01193920|BG002|Baseline|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
11027832|NCT01193920|BG003|Baseline|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
11027833|NCT01193920|BG004|Baseline|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
11027834|NCT01193920|BG005|Baseline|Pregnant/Placebo|Pregnant women who received one injection of saline solution
11027835|NCT01193920|BG006|Baseline|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
11027836|NCT01193920|BG007|Baseline|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
11027837|NCT01193920|BG008|Baseline|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
11027838|NCT01193920|BG009|Baseline|Infants / Placebo|Infants born from women who received one injection of saline solution
11027839|NCT01193920|BG010|Baseline|Total|Total of all reporting groups
11027840|NCT01193920|FG000|Participant Flow|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
11027841|NCT01193920|FG001|Participant Flow|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
11027842|NCT01193920|FG002|Participant Flow|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
11027843|NCT01193920|FG003|Participant Flow|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
11027844|NCT01193920|FG004|Participant Flow|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
11027845|NCT01193920|FG005|Participant Flow|Pregnant/Placebo|Pregnant women who received one injection of saline solution
11027846|NCT01193920|FG006|Participant Flow|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
11027847|NCT01193920|FG007|Participant Flow|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
11027848|NCT01193920|FG008|Participant Flow|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
11027849|NCT01193920|FG009|Participant Flow|Infants / Placebo|Infants born from women who received saline solution
11027850|NCT01193920|OG000|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
11027851|NCT01193920|OG001|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
11027852|NCT01193920|OG000|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
11027853|NCT01193920|OG001|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
11027854|NCT01193920|OG002|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
11027855|NCT01193920|OG003|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
11027856|NCT01193920|OG001|Outcome|Non Pregnant/Placebo|Non pregnant women received two injections of saline solution
11027857|NCT01193920|OG000|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
11027858|NCT01193920|OG001|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
11027859|NCT01193920|OG002|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
11027860|NCT01193920|OG003|Outcome|Infants / Placebo|Infants born from women who received saline solution
11027861|NCT01193920|EG000|Reported Event|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
11027862|NCT01193920|EG001|Reported Event|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
11027863|NCT01193920|EG002|Reported Event|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
11027864|NCT01193920|EG003|Reported Event|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
11027865|NCT01193920|EG004|Reported Event|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
11027866|NCT01193920|EG005|Reported Event|Pregnant/Placebo|Pregnant women who received one injection of saline solution
11027867|NCT01193920|EG006|Reported Event|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
11027868|NCT01193920|EG007|Reported Event|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
11027869|NCT01193920|EG008|Reported Event|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
11027870|NCT01193920|EG009|Reported Event|Infants / Placebo|Infants born from women who received one injection of saline solution
11027871|NCT01194089|BG000|Baseline|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
11027872|NCT01194089|BG001|Baseline|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
11027873|NCT01194089|BG002|Baseline|Total|Total of all reporting groups
11027874|NCT01194089|FG000|Participant Flow|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
11027875|NCT01194089|FG001|Participant Flow|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
11027876|NCT01194089|OG000|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
11027877|NCT01194089|OG001|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
11027878|NCT01194089|EG000|Reported Event|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
11027879|NCT01194089|EG001|Reported Event|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
11027880|NCT01194154|BG000|Baseline|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
11027881|NCT01194154|BG001|Baseline|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
11027882|NCT01194154|BG002|Baseline|Total|Total of all reporting groups
11027883|NCT01194154|FG000|Participant Flow|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
11027884|NCT01194154|FG001|Participant Flow|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
11027885|NCT01194154|OG000|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
11027886|NCT01194154|OG001|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
11027887|NCT01194154|OG000|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
11027888|NCT01194154|OG000|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/ dL.
11027889|NCT01194154|EG000|Reported Event|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
11027890|NCT01194154|EG001|Reported Event|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
11027891|NCT01194245|BG000|Baseline|Non-randomized Participants|"Participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.~Participants did not complete the titration period or did not meet one or more randomization criteria and, therefore, were not randomized."
11027892|NCT01194245|BG001|Baseline|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027893|NCT01194245|BG002|Baseline|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027894|NCT01194245|BG003|Baseline|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027895|NCT01194245|BG004|Baseline|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027896|NCT01194245|BG005|Baseline|Total|Total of all reporting groups
11027897|NCT01194245|FG000|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027898|NCT01194245|FG001|Participant Flow|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027899|NCT01194245|FG002|Participant Flow|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027900|NCT01194245|FG003|Participant Flow|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027901|NCT01194245|FG004|Participant Flow|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027902|NCT01194245|OG000|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
11027903|NCT01194245|OG001|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
11027904|NCT01194245|EG000|Reported Event|Titration Period (All Enrolled Participants)|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027905|NCT01194245|EG001|Reported Event|Lispro-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027906|NCT01194245|EG002|Reported Event|Insulin Lispro (Lispro-PH20 Cohort) Treatment Period|"Participants were randomized to the Lispro-PH20 cohort.~100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027907|NCT01194245|EG003|Reported Event|Aspart-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027908|NCT01194245|EG004|Reported Event|Insulin Lispro (Aspart-PH20 Cohort) Treatment Period|"Participants were randomized to the Aspart-PH20 cohort.~100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027909|NCT01194258|BG000|Baseline|All Study Participants|All participants in the study, including those who were enrolled but were not randomized.
11027910|NCT01194258|FG000|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected SC, pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027911|NCT01194258|FG001|Participant Flow|Insulin Lispro, Then Lispro-PH20|"Participants received a subcutaneous (SC) injection of 100 units per milliliter (U/mL) insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U insulin lispro and 5 micrograms (µg) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
11027912|NCT01194258|FG002|Participant Flow|Lispro-PH20, Then Insulin Lispro|"Participants received a SC injection of 100 U/mL insulin lispro and 5 µg rHuPH20 (Lispro-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
11027913|NCT01194258|FG003|Participant Flow|Insulin Lispro, Then Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (combined: Aspart-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
11027914|NCT01194258|FG004|Participant Flow|Aspart-PH20, Then Insulin Lispro|"Participants received SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (Aspart-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
11027915|NCT01194258|OG000|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
11027916|NCT01194258|OG001|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
11027917|NCT01194258|OG000|Outcome|Analog-PH20|100 U/mL insulin analog (Insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
11027918|NCT01194258|OG001|Outcome|Insulin-lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
11027919|NCT01194258|EG000|Reported Event|Titration Period|Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
11027920|NCT01194258|EG001|Reported Event|Insulin Lispro (Lispro-PH20 Cohort)|"Participants randomized to the Lispro-PH20 cohort.~Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027921|NCT01194258|EG002|Reported Event|Lispro-PH20|"Participants received a SC injection of 100 U/mL insulin lispro with 5 micrograms (μg) rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027922|NCT01194258|EG003|Reported Event|Insulin Lispro (Aspart-PH20 Cohort)|"Participants randomized to the Aspart-PH20 cohort.~Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027923|NCT01194258|EG004|Reported Event|Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin aspart and 5 μg rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
11027924|NCT01194271|BG000|Baseline|Neoadjuvant Ipilimumab|Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
11027925|NCT01194271|FG000|Participant Flow|Neoadjuvant Ipilimumab|Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
11027926|NCT01194271|OG000|Outcome|Neoadjuvant Ipilimumab|Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
11027927|NCT01194271|EG000|Reported Event|Neoadjuvant Ipilimumab|Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
11027928|NCT01194297|BG000|Baseline|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
11027929|NCT01194297|BG001|Baseline|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
11027930|NCT01194297|BG002|Baseline|Total|Total of all reporting groups
11027931|NCT01194297|FG000|Participant Flow|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
11027932|NCT01194297|FG001|Participant Flow|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
11027933|NCT01194297|OG000|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
11027934|NCT01194297|OG001|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
10886910|NCT00497146|OG000|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
10886911|NCT00497146|OG001|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
10886912|NCT00497146|EG000|Reported Event|Paricalcitol: Treatment Period|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks.
10886913|NCT00497146|EG001|Reported Event|Placebo: Treatment Period|Participants received 2 placebo capsules once a day for up to 48 weeks.
10886914|NCT00497146|EG002|Reported Event|Paricalcitol: Long-term Follow-up|Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
10886915|NCT00497146|EG003|Reported Event|Placebo: Long-term Follow-up|Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
10886916|NCT00497198|BG000|Baseline|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
10886917|NCT00497198|BG001|Baseline|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
10886918|NCT00497198|BG002|Baseline|Total|Total of all reporting groups
10886919|NCT00497198|FG000|Participant Flow|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
10886920|NCT00497198|FG001|Participant Flow|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
10886921|NCT00497198|OG000|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
10886922|NCT00497198|OG001|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
10886923|NCT00497198|EG000|Reported Event|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
10886924|NCT00497198|EG001|Reported Event|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
10886925|NCT00497289|BG000|Baseline|MCT:LCT:FO / 5:4:1|Lipidem 20%: daily i.v. infusion for up to 5 days
10886926|NCT00497289|BG001|Baseline|MCT:LCT / 1:1|Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days
10886927|NCT00497289|BG002|Baseline|Total|Total of all reporting groups
10886928|NCT00497289|FG000|Participant Flow|Lipidem 20 %|"Lipidem 20 %~Lipidem 20%: daily i.v. infusion for up to 5 days"
10886929|NCT00497289|FG001|Participant Flow|Lipofundin MCT/LCT 20%|"Lipofundin MCT/LCT 20%~Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days"
10886930|NCT00497289|OG000|Outcome|MCT:LCT:FO / 5:4:1|Lipidem 20%: daily i.v. infusion for up to 5 days
10886931|NCT00497289|OG001|Outcome|MCT:LCT / 1:1|Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days
10886932|NCT00497289|OG000|Outcome|MCT:LCT:FO / 5:4:1|"Lipidem 20 %~Lipidem 20%: daily i.v. infusion for up to 5 days"
10886933|NCT00497289|OG001|Outcome|MCT:LCT / 1:1|"Lipofundin MCT/LCT 20%~Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days"
10886934|NCT00497289|EG000|Reported Event|MCT/LCT/FO-containing 20% Fat Emulsion|"Preterm infants received a study treatment by parenteral route with MCT/LCT/FO~Lipidem 20%: daily i.v. infusion for up to 6 days"
10886935|NCT00497289|EG001|Reported Event|MCT/LCT Emulsion (20%)|"Preterm infants received a study treatment by parenteral route with MCT/LCT~Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 6 days"
10886936|NCT00497770|BG000|Baseline|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
10886937|NCT00497770|BG001|Baseline|African American|African American participants receiving pemetrexed for 2nd line NSCLC
10886938|NCT00497770|BG002|Baseline|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
10886939|NCT00497770|BG003|Baseline|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
10886940|NCT00497770|BG004|Baseline|Total|Total of all reporting groups
10886941|NCT00497770|FG000|Participant Flow|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
10886942|NCT00497770|FG001|Participant Flow|African American|African American participants receiving pemetrexed for 2nd line NSCLC
10886943|NCT00497770|FG002|Participant Flow|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
10886944|NCT00497770|FG003|Participant Flow|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
10886945|NCT00497770|OG000|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
10886946|NCT00497770|OG001|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
10886947|NCT00497770|OG002|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
10886948|NCT00497770|OG003|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
10886949|NCT00497770|OG000|Outcome|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
10886950|NCT00497770|EG000|Reported Event|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
10886951|NCT00497770|EG001|Reported Event|African American|African American participants receiving pemetrexed for 2nd line NSCLC
10886952|NCT00497770|EG002|Reported Event|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
10886953|NCT00497770|EG003|Reported Event|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
10886954|NCT00497796|BG000|Baseline|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
10886955|NCT00497796|BG001|Baseline|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
10886956|NCT00497796|BG002|Baseline|Total|Total of all reporting groups
10886957|NCT00497796|FG000|Participant Flow|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
10886958|NCT00497796|FG001|Participant Flow|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
10886959|NCT00497796|OG000|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
10886960|NCT00497796|OG001|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
10886961|NCT00497796|EG000|Reported Event|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
10886962|NCT00497796|EG001|Reported Event|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
10886963|NCT00497874|BG000|Baseline|Intervention|Stage-based manual and three computer-tailored reports
10886964|NCT00497874|BG001|Baseline|Usual Care|Usual primary care treatment
10886965|NCT00497874|BG002|Baseline|Total|Total of all reporting groups
10886966|NCT00497874|FG000|Participant Flow|Intervention|Stage-based manual and three computer-tailored reports
10886967|NCT00497874|FG001|Participant Flow|Usual Care|Usual primary care treatment
11027935|NCT01194297|EG000|Reported Event|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
10886968|NCT00497874|OG000|Outcome|Intervention|Usual primary care + computer-tailored intervention
10886969|NCT00497874|OG001|Outcome|Usual Care|Usual primary care
10886970|NCT00497874|OG000|Outcome|Intervention|Stage-based manual and three computer-tailored reports
10886971|NCT00497874|OG001|Outcome|Usual Care|Usual primary care treatment
10886972|NCT00497874|EG000|Reported Event|Intervention|Stage-based manual and three computer-tailored reports
10886973|NCT00497874|EG001|Reported Event|Usual Care|Usual primary care treatment
10886974|NCT00498173|BG000|Baseline|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
10886975|NCT00498173|BG001|Baseline|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
11027936|NCT01194297|EG001|Reported Event|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
10886976|NCT00498173|BG002|Baseline|Total|Total of all reporting groups
10886977|NCT00498173|FG000|Participant Flow|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
10886978|NCT00498173|FG001|Participant Flow|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
10886979|NCT00498173|FG002|Participant Flow|Atomoxetine (Open Label Trial)|Placebo-treated subjects from the randomized trial that don't respond to placebo will be offered an 8-week open-label trial of atomoxetine.
10886980|NCT00498173|OG000|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
10886981|NCT00498173|OG001|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
10886982|NCT00498173|OG000|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
10886983|NCT00498173|EG000|Reported Event|Atomoxetine (Randomized)|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
10886984|NCT00498173|EG001|Reported Event|Placebo (Randomized)|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
10886985|NCT00498173|EG002|Reported Event|Atomoxetine (Open Label Trial)|Placebo-treated subjects from the randomized trial that don't respond to placebo will be offered an 8-week open-label trial of atomoxetine
10886986|NCT00498186|BG000|Baseline|Rotigotine|Rotigotine trans-dermal patch
10886987|NCT00498186|FG000|Participant Flow|Rotigotine|Rotigotine trans-dermal patch
11027937|NCT01194414|BG000|Baseline|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
11027938|NCT01194414|BG001|Baseline|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
11027939|NCT01194414|BG002|Baseline|Total|Total of all reporting groups
11027940|NCT01194414|FG000|Participant Flow|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027941|NCT01194414|FG001|Participant Flow|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027942|NCT01194414|FG002|Participant Flow|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027943|NCT01194414|FG003|Participant Flow|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
11027944|NCT01194414|OG000|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
11027945|NCT01194414|OG001|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
11027946|NCT01194414|OG000|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027947|NCT01194414|OG001|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027948|NCT01194414|OG002|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027949|NCT01194414|OG003|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
11027950|NCT01194414|EG000|Reported Event|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027951|NCT01194414|EG001|Reported Event|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027952|NCT01194414|EG002|Reported Event|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
11027953|NCT01194414|EG003|Reported Event|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
10886988|NCT00498186|OG000|Outcome|Rotigotine|Rotigotine trans-dermal patch
11148926|NCT01867710|EG002|Reported Event|Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148927|NCT01867710|EG003|Reported Event|Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
11148928|NCT01868009|BG000|Baseline|DISKUS BID in Period 1 or 2; ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive one of the following two sequences of DPIs containing placebo: (1) DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2; (2) ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
11148929|NCT01868009|FG000|Participant Flow|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current chronic obstructive pulmonary disease (COPD) medication(s) were randomized to receive DISKUS twice a day (BID) for 5-9 days in Period 1 and ELLIPTA once a day (QD) for 5-9 days in Period 2. There was no washout period between the two periods. Neither dry powder inhaler (DPI) contained any active treatment; placebo was administered in both DPIs.
11148930|NCT01868009|FG001|Participant Flow|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
11148931|NCT01868009|OG000|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
11148932|NCT01868009|OG001|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
11148933|NCT01868009|EG000|Reported Event|ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in either Period 1 or Period 2. There was no washout period between the two periods. The DPI did not contain any active treatment; placebo was administered in the DPI.
11148934|NCT01868009|EG001|Reported Event|DISKUS BID in Period 1 or 2|Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period.
11148935|NCT01868022|BG000|Baseline|5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
11148936|NCT01868022|BG001|Baseline|10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11148937|NCT01868022|BG002|Baseline|20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11148938|NCT01868022|BG003|Baseline|5 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11148939|NCT01868022|BG004|Baseline|10 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11148940|NCT01868022|BG005|Baseline|20 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11148941|NCT01868022|BG006|Baseline|10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11148942|NCT01868022|BG007|Baseline|15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11148943|NCT01868022|BG008|Baseline|20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11148944|NCT01868022|BG009|Baseline|Total|Total of all reporting groups
11148945|NCT01868022|FG000|Participant Flow|5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
11148946|NCT01868022|FG001|Participant Flow|10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11148947|NCT01868022|FG002|Participant Flow|20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11148948|NCT01868022|FG003|Participant Flow|5 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11148949|NCT01868022|FG004|Participant Flow|10 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11148950|NCT01868022|FG005|Participant Flow|20 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11148951|NCT01868022|FG006|Participant Flow|10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11027954|NCT01194440|BG000|Baseline|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
11027955|NCT01194440|FG000|Participant Flow|Arm I - IV Zoledronic Acid Prophylaxis|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
11027956|NCT01194440|OG000|Outcome|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
11027957|NCT01194440|OG000|Outcome|Arm I - IV Zoledronic Acid Prophylaxis|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
11027958|NCT01194440|EG000|Reported Event|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
11027959|NCT01194453|BG000|Baseline|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
11027960|NCT01194453|BG001|Baseline|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
11027961|NCT01194453|BG002|Baseline|Total|Total of all reporting groups
11027962|NCT01194453|FG000|Participant Flow|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
11027963|NCT01194453|FG001|Participant Flow|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
11027964|NCT01194453|OG000|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
11027965|NCT01194453|OG001|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
11027966|NCT01194453|EG000|Reported Event|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
11027967|NCT01194453|EG001|Reported Event|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
11027968|NCT01194466|BG000|Baseline|All Participants|All participants' characteristics, prior to first treatment
11027969|NCT01194466|FG000|Participant Flow|Order: Active, Placebo, No TENS|Active high frequency TENS will be used visit 1 Washout 6 days Placebo for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2
11027970|NCT01194466|FG001|Participant Flow|Order: Placebo, Active, No TENS|Placebo low frequency TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2
10886989|NCT00498186|EG000|Reported Event|Rotigotine|Rotigotine trans-dermal patch
11027971|NCT01194466|FG002|Participant Flow|Order: No TENS, Active, Placebo|No TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days Placebo Low Intensity TENS visit 3- 7 days after visit 2
11027972|NCT01194466|OG000|Outcome|Active TENS|Each participant received an Active TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Active TENS condition. Active TENS was delivered for 30 minutes at a frequency of 125Hz and a pulse duration of 100 2s on continuous mode output (calibrated using an oscilloscope before the study). Transcutaneous electrical nerve stimulation intensity was increased by the allocator until patients reported a ''maximally strong but comfortable sensation'' to ensure an analgesic effect.
11027973|NCT01194466|OG001|Outcome|Placebo TENS|Each participant received an Placebo TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Placebo TENS condition. Placebo TENS parameters were identical to active TENS (125 Hz, 100 2s). A novel, transient placebo TENS unit, previously tested and validated, was used. The intensity was increased until patients first felt ''any sensation at all (sensory threshold)'' in any electrode (ie, they did not have to reach sensory threshold in all electrodes). The placebo device then provided a current for 30 seconds and decreased gradually over 15 seconds to 0 output (ie, 45 seconds from the first sensory threshold). An indicator light remained on for the remainder of the visit so it appeared to the participant and outcomes assessor that the unit was still producing current.
11027974|NCT01194466|OG002|Outcome|No TENS|Each participant received a No TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the No TENS condition. No TENS parameters were identical to active and placebo TENS, except that (1) the unit was never turned on and (2) participants were told that the unit was not on.
11027975|NCT01194466|EG000|Reported Event|Active TENS|"Active high frequency TENS will be use for Active TENS.~Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2)."
11027976|NCT01194466|EG001|Reported Event|Low Intensity TENS|"Low Intensity TENS will be applied for one arm of the study~Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2)."
11027977|NCT01194466|EG002|Reported Event|No Treatment|"TENS unit in place but not turned on~Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2)."
11027978|NCT01194479|BG000|Baseline|Healthy Volunteers|"The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.~Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration~Placebo: Participants in both arms received placebo on 1 of the 2 visits."
11027979|NCT01194479|BG001|Baseline|Type 1 Diabetics|"The active group were participants with type 1 diabetes.~Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration~Placebo: Participants in both arms received placebo on 1 of the 2 visits."
11027980|NCT01194479|BG002|Baseline|Total|Total of all reporting groups
11027981|NCT01194479|FG000|Participant Flow|Control: Placebo|Healthy volunteers that received Placebo first, the Formoterol.
11027982|NCT01194479|FG001|Participant Flow|Control: Formoterol|Healthy volunteers that received Formoterol first, then Placebo.
11027983|NCT01194479|FG002|Participant Flow|Type 1 Diabetics: Placebo|Type 1 Diabetics that received Placebo first, then Formoterol.
11027984|NCT01194479|FG003|Participant Flow|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol first, then Placebo.
11027985|NCT01194479|OG000|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
11027986|NCT01194479|OG001|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
11027987|NCT01194479|OG002|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
11027988|NCT01194479|OG003|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
11027989|NCT01194479|EG000|Reported Event|Control: Placebo|Healthy volunteers that received Placebo on the first visit.
11027990|NCT01194479|EG001|Reported Event|Control: Formoterol|Healthy volunteers that received Formoterol on the first visit.
11027991|NCT01194479|EG002|Reported Event|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first visit.
11027992|NCT01194479|EG003|Reported Event|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first visit.
11027993|NCT01194531|BG000|Baseline|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
11027994|NCT01194531|BG001|Baseline|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
11027995|NCT01194531|BG002|Baseline|Total|Total of all reporting groups
11027996|NCT01194531|FG000|Participant Flow|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
11027997|NCT01194531|FG001|Participant Flow|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
11027998|NCT01194531|OG000|Outcome|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
11027999|NCT01194531|OG001|Outcome|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
11028000|NCT01194531|EG000|Reported Event|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
11028001|NCT01194531|EG001|Reported Event|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
11028002|NCT01194674|BG000|Baseline|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
11028003|NCT01194674|FG000|Participant Flow|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
11028004|NCT01194674|OG000|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
11028005|NCT01194674|OG000|Outcome|Microplasmin|Microplasmin: Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
11028006|NCT01194674|EG000|Reported Event|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
11028007|NCT01194804|BG000|Baseline|Eculizumab|"Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol~900 mg intravenous every 14 days."
11028008|NCT01194804|FG000|Participant Flow|Eculizumab|"Treatment with eculizumab for patients with paroxysmal nocturnal hemoglobinuria who have successfully completed the C07-001 protocol (NCT01192399)~Eculizumab: 900 mg intravenous every 14 days."
11028009|NCT01194804|OG000|Outcome|Eculizumab|"Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol~900 mg intravenous every 14 days."
11028010|NCT01194804|EG000|Reported Event|Eculizumab|"Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol~900 mg intravenous every 14 days."
11028011|NCT01194830|BG000|Baseline|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
11028012|NCT01194830|BG001|Baseline|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
11028013|NCT01194830|BG002|Baseline|Total|Total of all reporting groups
11028014|NCT01194830|FG000|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
11028015|NCT01194830|FG001|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
11028016|NCT01194830|OG000|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
11028017|NCT01194830|OG001|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
11028018|NCT01194830|EG000|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
11028019|NCT01194830|EG001|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
11028020|NCT01194869|BG000|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
11028021|NCT01194869|FG000|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
11028022|NCT01194869|OG000|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
11028023|NCT01194869|EG000|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
11028024|NCT01194973|BG000|Baseline|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
11028025|NCT01194973|FG000|Participant Flow|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
11028026|NCT01194973|OG000|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
11028027|NCT01194973|EG000|Reported Event|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
11028028|NCT01194999|BG000|Baseline|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
11028029|NCT01194999|FG000|Participant Flow|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
11028030|NCT01194999|OG000|Outcome|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
11028031|NCT01194999|EG000|Reported Event|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
11028032|NCT01195025|BG000|Baseline|Dilution Effects of iv Fluids|"Three experiments:~A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxy ethyl starch (HES) 6% 10 mL/kg bodyweight during 30 min C. A combination of A and B. HES during 0-30 min and Ringer's during 105-135 minutes."
11148952|NCT01868022|FG007|Participant Flow|15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11148953|NCT01868022|FG008|Participant Flow|20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11028033|NCT01195025|FG000|Participant Flow|A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
11028034|NCT01195025|FG001|Participant Flow|A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected"
11028035|NCT01195025|FG002|Participant Flow|A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by 150 minutes of equilibration, when blood samples were collected~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples."
11028036|NCT01195025|FG003|Participant Flow|A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
11028037|NCT01195025|FG004|Participant Flow|A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected."
11028038|NCT01195025|OG000|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
11028039|NCT01195025|OG000|Outcome|Venous Hemoglobin and Non-invasive Hemoglobin (SpHb)|"A comparison of all paired hemoglobin measurements (B-Hb and SpHb) during the experiments for all the 10 volunteers.~Relative difference(%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"
11028040|NCT01195025|OG000|Outcome|Colloid (Voluven), Acetated Ringers and a Combination of Both.|"A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes~The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant."
11028041|NCT01195025|EG000|Reported Event|Colloid-, Acetated Ringers and Combined|"Voluven, acetated Ringers: Infusions at three different occasions separated by at least one week.~A. acetated Ringers 25 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes. C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 15 ml/kg bodyweight during 30 minutes."
11028042|NCT01195090|BG000|Baseline|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
11028043|NCT01195090|BG001|Baseline|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
11028044|NCT01195090|BG002|Baseline|Total|Total of all reporting groups
11028045|NCT01195090|FG000|Participant Flow|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
11028046|NCT01195090|FG001|Participant Flow|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
11028047|NCT01195090|OG000|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
11028048|NCT01195090|OG001|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
11028049|NCT01195090|EG000|Reported Event|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
11028050|NCT01195090|EG001|Reported Event|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
11028051|NCT01195103|BG000|Baseline|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
11028052|NCT01195103|BG001|Baseline|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
11028053|NCT01195103|BG002|Baseline|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
11028054|NCT01195103|BG003|Baseline|Total|Total of all reporting groups
11028055|NCT01195103|FG000|Participant Flow|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
11028056|NCT01195103|FG001|Participant Flow|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
11028057|NCT01195103|FG002|Participant Flow|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
11028058|NCT01195103|OG000|Outcome|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
11028059|NCT01195103|OG001|Outcome|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
11028060|NCT01195103|OG002|Outcome|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
11028061|NCT01195103|EG000|Reported Event|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
11028062|NCT01195103|EG001|Reported Event|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
11028063|NCT01195103|EG002|Reported Event|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
11028064|NCT01195116|BG000|Baseline|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
11028065|NCT01195116|BG001|Baseline|Normal Saline|Normal Saline: 1mcg/kg/hr
11028066|NCT01195116|BG002|Baseline|Total|Total of all reporting groups
11028067|NCT01195116|FG000|Participant Flow|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
11028068|NCT01195116|FG001|Participant Flow|Normal Saline|Normal Saline: 1mcg/kg/hr
11028069|NCT01195116|OG000|Outcome|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
11028070|NCT01195116|OG001|Outcome|Normal Saline|Normal Saline: 1mcg/kg/hr
11028071|NCT01195116|EG000|Reported Event|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
11028072|NCT01195116|EG001|Reported Event|Normal Saline|Normal Saline: 1mcg/kg/hr
11028073|NCT01195272|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
11028074|NCT01195272|FG000|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) intravenously (IV), once every 4 weeks up to 52 weeks (total of 13 infusions).
11028075|NCT01195272|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
11028076|NCT01195272|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
11028077|NCT01195363|BG000|Baseline|Active Quetiapine SR|mood stabilizer plus active quetiapine sr
11028078|NCT01195363|BG001|Baseline|Quetiapine SR Placebo|mood stabilizer plus quetiapine SR placebo
11028079|NCT01195363|BG002|Baseline|Total|Total of all reporting groups
11148954|NCT01868022|OG000|Outcome|5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
11148955|NCT01868022|OG001|Outcome|10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11028080|NCT01195363|FG000|Participant Flow|Quetiapine SR, 200-600mg , po, QD|mood stabilizer plus active quetiapine SR
11028081|NCT01195363|FG001|Participant Flow|Quetiapine sr Placebo 200-600mg, po, qd|mood stabilizer plus quetiapine SR placebo
11028082|NCT01195363|OG000|Outcome|Active Quetiapine S.R., 200-600mg, po, qd|Atypical antipsychotic quetiapine S.R. plus mood stabilizer
11028083|NCT01195363|OG001|Outcome|Placebo Quetiapine S.R. 200-600mg, po, qd|mood stabilizer plus quetiapine S.R. placebo
11028084|NCT01195363|EG000|Reported Event|Mood Stabilizer Plus Quetiapine SR|mood stabilizer plus active quetiapine SR
11028085|NCT01195363|EG001|Reported Event|Mood Stabilizer Plus Quetiapine sr Placebo|mood stabilizer plus quetiapine SR placebo
11028086|NCT01195415|BG000|Baseline|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11028087|NCT01195415|FG000|Participant Flow|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11028088|NCT01195415|OG000|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11028089|NCT01195415|EG000|Reported Event|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11028090|NCT01195467|BG000|Baseline|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
11028091|NCT01195467|FG000|Participant Flow|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
11028092|NCT01195467|OG000|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
11028093|NCT01195467|EG000|Reported Event|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
11028094|NCT01195545|BG000|Baseline|Veritas Mesh in Hernia Repair|Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
11028095|NCT01195545|FG000|Participant Flow|Veritas Mesh in Hernia Repair|Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
11028096|NCT01195545|OG000|Outcome|Veritas Mesh in Hernia Repair|Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
11028097|NCT01195545|EG000|Reported Event|Experimental|Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
11028098|NCT01195584|BG000|Baseline|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
11028099|NCT01195584|BG001|Baseline|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
11028100|NCT01195584|BG002|Baseline|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
11028101|NCT01195584|BG003|Baseline|Total|Total of all reporting groups
11028102|NCT01195584|FG000|Participant Flow|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
11028103|NCT01195584|FG001|Participant Flow|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
11028104|NCT01195584|FG002|Participant Flow|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
11028105|NCT01195584|OG000|Outcome|Complications|Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
11028106|NCT01195584|OG000|Outcome|Duration|Duration of surgery
11028107|NCT01195584|OG000|Outcome|Blood Loss|
11028108|NCT01195584|OG000|Outcome|Number of Segments|Number of affected spine segments
11028109|NCT01195584|OG000|Outcome|Hospitalization|Days of hospitalization
11028110|NCT01195584|EG000|Reported Event|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
11028111|NCT01195584|EG001|Reported Event|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
11028112|NCT01195584|EG002|Reported Event|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
11028113|NCT01195597|BG000|Baseline|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
11028114|NCT01195597|FG000|Participant Flow|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
11028115|NCT01195597|OG000|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
11028116|NCT01195597|EG000|Reported Event|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
11028117|NCT01195623|BG000|Baseline|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
11028118|NCT01195623|BG001|Baseline|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
11028119|NCT01195623|BG002|Baseline|Total|Total of all reporting groups
11028120|NCT01195623|FG000|Participant Flow|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
11028121|NCT01195623|FG001|Participant Flow|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
11028122|NCT01195623|OG000|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
11028123|NCT01195623|OG001|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
11028124|NCT01195623|EG000|Reported Event|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
11028125|NCT01195623|EG001|Reported Event|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
11028126|NCT01195636|BG000|Baseline|XPF-002 First, Then Placebo|XPF-002 ointment applied twice daily for 3 weeks followed by Placebo ointment applied twice daily for 3 weeks (after a washout period)
11028127|NCT01195636|BG001|Baseline|Placebo First, Then XPF-002|Placebo ointment applied twice daily for 3 weeks followed by XPF-002 ointment applied twice daily for 3 weeks (after a washout period)
11028128|NCT01195636|BG002|Baseline|Total|Total of all reporting groups
11028129|NCT01195636|FG000|Participant Flow|XPF-002 First, Then Placebo|In the first intervention period XPF-002 ointment (8% strength) was applied twice daily for 3 weeks. After a washout period, Placebo ointment was applied twice daily for 3 weeks in the second intervention period.
11028130|NCT01195636|FG001|Participant Flow|Placebo First, Then XPF-002|In the first intervention period Placebo ointment was applied twice daily for 3 weeks. After a washout period, XPF-002 ointment (8% strength) was applied twice daily for 3 weeks in the second intervention period.
11028131|NCT01195636|OG000|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
11028132|NCT01195636|OG001|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
11028133|NCT01195636|EG000|Reported Event|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
11028134|NCT01195636|EG001|Reported Event|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
11028135|NCT01195662|BG000|Baseline|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028136|NCT01195662|BG001|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028137|NCT01195662|BG002|Baseline|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|Dapagliflozin: Tablets, Oral, 5 mg, once daily, Up to 12 weeks. This arm discontinued with implementation of Amendment 8 to the protocol (1 November 2011). Study continued to enroll participants in other 2 arms post Amendment 8. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028138|NCT01195662|BG003|Baseline|Total|Total of all reporting groups
11028139|NCT01195662|FG000|Participant Flow|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028140|NCT01195662|FG001|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028141|NCT01195662|FG002|Participant Flow|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
11028142|NCT01195662|OG000|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028143|NCT01195662|OG001|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028144|NCT01195662|OG000|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks.Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028145|NCT01195662|OG002|Outcome|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
11028146|NCT01195662|EG000|Reported Event|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11028147|NCT01195662|EG001|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
11148956|NCT01868022|OG002|Outcome|20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11148957|NCT01868022|OG003|Outcome|5 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11028148|NCT01195662|EG002|Reported Event|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
11028149|NCT01195675|BG000|Baseline|Study Overall|Total number of patients randomised and treated in the study.
11028150|NCT01195675|FG000|Participant Flow|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, placebo controlled, 5-period crossover trial, participants were randomised to one of ten possible treatment sequences. The treatments administered were~25mg empa administered orally on day 1 of the treatment period~200mg empa administered orally on day 1 of the treatment period~400mg moxifloxacin administered orally on day 1 of the treatment period~Placebo 1 administered orally on day 1 of the treatment period~Placebo 2 administered orally on day 1 of the treatment period~The trial was double-blind for the placebo and Empagliflozin (Empa) treatments, but open-label for the moxifloxacin treatment. A washout period of at least 1 week was respected between drug administrations."
11028151|NCT01195675|OG000|Outcome|Placebo|Single oral dose of placebo (8 tablets).
11028152|NCT01195675|OG001|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
11028153|NCT01195675|OG001|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
11028154|NCT01195675|OG001|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
11028155|NCT01195675|OG000|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
11028156|NCT01195675|OG002|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
11028157|NCT01195675|OG001|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
11028158|NCT01195675|OG002|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
11028159|NCT01195675|OG003|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
11028160|NCT01195675|EG000|Reported Event|Placebo|Single oral dose of placebo (8 tablets).
11028161|NCT01195675|EG001|Reported Event|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
11028162|NCT01195675|EG002|Reported Event|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
11028163|NCT01195675|EG003|Reported Event|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
11028164|NCT01195701|BG000|Baseline|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
11028165|NCT01195701|BG001|Baseline|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
11028166|NCT01195701|BG002|Baseline|Total|Total of all reporting groups
11028167|NCT01195701|FG000|Participant Flow|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
11028168|NCT01195701|FG001|Participant Flow|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
11028169|NCT01195701|OG000|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
11028170|NCT01195701|OG001|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
11028171|NCT01195701|EG000|Reported Event|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
11028172|NCT01195701|EG001|Reported Event|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
11028173|NCT01195779|BG000|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
11028174|NCT01195779|BG001|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
11028175|NCT01195779|BG002|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
11028176|NCT01195779|BG003|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
11028177|NCT01195779|BG004|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
11028178|NCT01195779|BG005|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
11028179|NCT01195779|BG006|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
11028180|NCT01195779|BG007|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
11028181|NCT01195779|BG008|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
11028182|NCT01195779|BG009|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
11028183|NCT01195779|BG010|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
11028184|NCT01195779|BG011|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
11028185|NCT01195779|BG012|Baseline|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
11028186|NCT01195779|BG013|Baseline|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
11028187|NCT01195779|BG014|Baseline|Total|Total of all reporting groups
11028188|NCT01195779|FG000|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
11028189|NCT01195779|FG001|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
11028190|NCT01195779|FG002|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
11028191|NCT01195779|FG003|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
11028192|NCT01195779|FG004|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
11028193|NCT01195779|FG005|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
11028194|NCT01195779|FG006|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
11028195|NCT01195779|FG007|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
11028196|NCT01195779|FG008|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
11028197|NCT01195779|FG009|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
11028198|NCT01195779|FG010|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
11028199|NCT01195779|FG011|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
11028200|NCT01195779|FG012|Participant Flow|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
11028201|NCT01195779|FG013|Participant Flow|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
11028202|NCT01195779|OG000|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
11028203|NCT01195779|OG001|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
11028204|NCT01195779|OG002|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
11028205|NCT01195779|OG003|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
11028206|NCT01195779|OG004|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
11028207|NCT01195779|OG005|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
11028208|NCT01195779|OG006|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
11028209|NCT01195779|OG007|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
11028210|NCT01195779|OG008|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
11028211|NCT01195779|OG009|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
11028212|NCT01195779|OG010|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
11028213|NCT01195779|OG011|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
11028214|NCT01195779|OG012|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
11028215|NCT01195779|OG013|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
11028216|NCT01195779|EG000|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
11028217|NCT01195779|EG001|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
11028218|NCT01195779|EG002|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
11028219|NCT01195779|EG003|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
11028220|NCT01195779|EG004|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
11028221|NCT01195779|EG005|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
11028222|NCT01195779|EG006|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
11028223|NCT01195779|EG007|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
11028224|NCT01195779|EG008|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
11028225|NCT01195779|EG009|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
11028226|NCT01195779|EG010|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
11028227|NCT01195779|EG011|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
11028228|NCT01195779|EG012|Reported Event|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
11028229|NCT01195779|EG013|Reported Event|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
11028230|NCT01195831|BG000|Baseline|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
11028231|NCT01195831|BG001|Baseline|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
11028232|NCT01195831|BG002|Baseline|Total|Total of all reporting groups
11028233|NCT01195831|FG000|Participant Flow|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
11028234|NCT01195831|FG001|Participant Flow|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
11028235|NCT01195831|OG000|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
11028236|NCT01195831|OG001|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
11028237|NCT01195831|EG000|Reported Event|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
11028238|NCT01195831|EG001|Reported Event|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
11028239|NCT01195844|BG000|Baseline|Children Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
11028240|NCT01195844|FG000|Participant Flow|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
11028241|NCT01195844|OG000|Outcome|Children Hospitalized For Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
11028242|NCT01195844|OG000|Outcome|Children Hospitalized for Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
11028243|NCT01195844|OG000|Outcome|Salvador (Northeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Salvador (Northeast Brazil) hospital research center
11028244|NCT01195844|OG001|Outcome|Goiânia (Center-West)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
11028245|NCT01195844|OG002|Outcome|Porto Alegre (South)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
11028246|NCT01195844|OG003|Outcome|São Paulo (Southeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
11028247|NCT01195844|OG000|Outcome|Children Hospitalized For Diarrhea Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers
11028248|NCT01195844|OG000|Outcome|Children Hospitalized For Rotavirus-Positive Diarrhea|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the 4 Brazilian hospital research centers
11028249|NCT01195844|OG000|Outcome|Total Number Hospitalized For Diarrhea of Any Cause|Total number of children up to 5 years of age hospitalized for diarrhea of any cause in the 4 Brazilian hospital research centers
11028250|NCT01195844|OG001|Outcome|Total Number Diagnosed With Rotavirus Diarrhea|Children up to 5 years of age diagnosed with rotavirus diarrhea in the 4 Brazilian hospital research centers
11028251|NCT01195844|OG000|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
11028252|NCT01195844|EG000|Reported Event|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
11028253|NCT01195883|BG000|Baseline|Crystalloid|"Lactated Ringers solution will be used for fluid replacement.~Crystalloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes."
11028254|NCT01195883|BG001|Baseline|Colloid|"Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement~Colloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes."
11028255|NCT01195883|BG002|Baseline|Total|Total of all reporting groups
11028256|NCT01195883|FG000|Participant Flow|Crystalloid|"Lactated Ringers solution will be used for fluid replacement.~Crystalloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes."
11028257|NCT01195883|FG001|Participant Flow|Colloid|"Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement~Colloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes."
11028258|NCT01195883|OG000|Outcome|Crystalloid|"Lactated Ringers solution will be used for fluid replacement.~Crystalloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes."
11028259|NCT01195883|OG001|Outcome|Colloid|"Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement~Colloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes."
11028260|NCT01195883|EG000|Reported Event|Crystalloid|"Lactated Ringers solution will be used for fluid replacement.~Crystalloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes."
11028261|NCT01195883|EG001|Reported Event|Colloid|"Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement~Colloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes."
11028262|NCT01195922|BG000|Baseline|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
11028263|NCT01195922|FG000|Participant Flow|Sirolimus|Rapamycin (sirolimus), dispensed as either tablets or an oral solution for patients with dysphagia was administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Dose reductions to 3 mg by mouth once per day were implemented if levels of rapamycin > 20 ng/ml occurred on Days 8 or 15.
11028264|NCT01195922|OG000|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
11028265|NCT01195922|EG000|Reported Event|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
11028266|NCT01195948|BG000|Baseline|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028267|NCT01195948|BG001|Baseline|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028268|NCT01195948|BG002|Baseline|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028269|NCT01195948|BG003|Baseline|Total|Total of all reporting groups
11028270|NCT01195948|FG000|Participant Flow|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028271|NCT01195948|FG001|Participant Flow|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028272|NCT01195948|FG002|Participant Flow|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028273|NCT01195948|OG000|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
11028274|NCT01195948|OG001|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
11028275|NCT01195948|OG002|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
11028276|NCT01195948|OG000|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028277|NCT01195948|OG001|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028278|NCT01195948|OG002|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
11028279|NCT01195948|EG000|Reported Event|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
11028280|NCT01195948|EG001|Reported Event|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
11028281|NCT01195948|EG002|Reported Event|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
11028282|NCT01196026|BG000|Baseline|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028283|NCT01196026|BG001|Baseline|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028284|NCT01196026|BG002|Baseline|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028285|NCT01196026|BG003|Baseline|Havrix Junior 6-11 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028286|NCT01196026|BG004|Baseline|Havrix Junior 12-35 Months Group|Subjects aged 12-35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine.
11028287|NCT01196026|BG005|Baseline|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028288|NCT01196026|BG006|Baseline|Total|Total of all reporting groups
11028289|NCT01196026|FG000|Participant Flow|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028290|NCT01196026|FG001|Participant Flow|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028291|NCT01196026|FG002|Participant Flow|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028292|NCT01196026|FG003|Participant Flow|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028293|NCT01196026|FG004|Participant Flow|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028294|NCT01196026|FG005|Participant Flow|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028295|NCT01196026|OG000|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028296|NCT01196026|OG001|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028297|NCT01196026|OG002|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028298|NCT01196026|OG003|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028299|NCT01196026|OG004|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028300|NCT01196026|OG005|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028301|NCT01196026|OG006|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
11028302|NCT01196026|OG007|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
11028303|NCT01196026|EG000|Reported Event|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028304|NCT01196026|EG001|Reported Event|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028305|NCT01196026|EG002|Reported Event|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
11028306|NCT01196026|EG003|Reported Event|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028307|NCT01196026|EG004|Reported Event|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028308|NCT01196026|EG005|Reported Event|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
11028309|NCT01196052|BG000|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
11028310|NCT01196052|FG000|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
11028311|NCT01196052|OG000|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
11028312|NCT01196052|EG000|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
11028313|NCT01196078|BG000|Baseline|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
11028314|NCT01196078|BG001|Baseline|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
11028315|NCT01196078|BG002|Baseline|Total|Total of all reporting groups
11028316|NCT01196078|FG000|Participant Flow|Erlotinib|Participants received erlotinib 150 milligrams (mg), tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
11028317|NCT01196078|FG001|Participant Flow|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 milligrams per square meter (mg/m^2) orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 adverse events [AEs]) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
11028318|NCT01196078|OG000|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
11028319|NCT01196078|OG001|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
11028320|NCT01196078|EG000|Reported Event|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
11028321|NCT01196078|EG001|Reported Event|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
11028322|NCT01196091|BG000|Baseline|LY2127399 Every 2 Weeks|LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
11028323|NCT01196091|BG001|Baseline|LY2127399 Every 4 Wks|"During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.~LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.~Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks."
10886990|NCT00498355|BG000|Baseline|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
10886991|NCT00498355|FG000|Participant Flow|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
10886992|NCT00498355|OG000|Outcome|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
10886993|NCT00498355|OG000|Outcome|Ranibizumab|Ranibizumab: 0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.
10886994|NCT00498355|EG000|Reported Event|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
10886995|NCT00498368|BG000|Baseline|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
10886996|NCT00498368|BG001|Baseline|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
10886997|NCT00498368|BG002|Baseline|Total|Total of all reporting groups
10886998|NCT00498368|FG000|Participant Flow|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
10886999|NCT00498368|FG001|Participant Flow|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
10887000|NCT00498368|OG000|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
11028324|NCT01196091|BG002|Baseline|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
11028325|NCT01196091|BG003|Baseline|Total|Total of all reporting groups
10887001|NCT00498368|OG001|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
10887002|NCT00498368|EG000|Reported Event|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
10887003|NCT00498368|EG001|Reported Event|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
10887004|NCT00498433|BG000|Baseline|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
10887005|NCT00498433|BG001|Baseline|Part 2, Double Blind Period: Aliskiren|Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
10887006|NCT00498433|BG002|Baseline|Part 2, Double Blind: Amlodipine|Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
10887007|NCT00498433|BG003|Baseline|Total|Total of all reporting groups
10887008|NCT00498433|FG000|Participant Flow|Placebo|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 2, Period 1: After confirming study eligibility based on inclusion and exclusion criteria, patients underwent a two week single-blind placebo run-in phase."
11028326|NCT01196091|FG000|Participant Flow|LY2127399 Every 2 Weeks|LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
11148958|NCT01868022|OG004|Outcome|10 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11028327|NCT01196091|FG001|Participant Flow|LY2127399 Every 4 Wks|"During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.~LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.~Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks."
11028328|NCT01196091|FG002|Participant Flow|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
11028329|NCT01196091|OG000|Outcome|LY2127399 Every 2 Weeks|LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
11028330|NCT01196091|OG001|Outcome|LY2127399 Every 4 Wks|"During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.~LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.~Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks."
11028331|NCT01196091|OG002|Outcome|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
11028332|NCT01196091|OG002|Outcome|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at first dose.
11028333|NCT01196091|OG002|Outcome|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
11028334|NCT01196091|EG000|Reported Event|LY2127399 Every 2 Weeks|LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
11028335|NCT01196091|EG001|Reported Event|LY2127399 Every 4 Wks|"During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.~LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.~Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks."
11028336|NCT01196091|EG002|Reported Event|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
11028337|NCT01196091|EG003|Reported Event|LY2127399 Every 2 Weeks, Follow Up|24-48 weeks post last dose
11028338|NCT01196091|EG004|Reported Event|LY2127399 Every 4 Wks, Follow Up|24-48 weeks post last dose
11028339|NCT01196091|EG005|Reported Event|Placebo, Follow Up|24-48 weeks post last dose
11028340|NCT01196104|BG000|Baseline|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
11028341|NCT01196104|BG001|Baseline|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
11028342|NCT01196104|BG002|Baseline|Total|Total of all reporting groups
11028343|NCT01196104|FG000|Participant Flow|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
11028344|NCT01196104|FG001|Participant Flow|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
11028345|NCT01196104|OG000|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
11028346|NCT01196104|OG001|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
11028347|NCT01196104|OG000|Outcome|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder~Technosphere® Insulin Inhalation Powder~Insulin Glargine"
11028348|NCT01196104|OG001|Outcome|Comparator|"Insulin Glargine and Insulin Aspart~Insulin Aspart: Usual Care~Insulin Glargine"
11028349|NCT01196104|EG000|Reported Event|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder~Technosphere® Insulin Inhalation Powder~Insulin Glargine"
11028350|NCT01196104|EG001|Reported Event|Comparator|"Insulin Glargine and Insulin Aspart~Insulin Aspart: Usual Care~Insulin Glargine"
11028351|NCT01196117|BG000|Baseline|All Study Participants|Participants received 14 days of placebo therapy then 14 days of continuous positive airway pressure (CPAP) therapy
11028352|NCT01196117|FG000|Participant Flow|14 Days of Placebo Therapy|14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
11028353|NCT01196117|FG001|Participant Flow|14 Days of Continuous Positive Airway Pressure (CPAP) Therapy|14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
11028354|NCT01196117|OG000|Outcome|14 Days of Placebo Therapy|14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
11028355|NCT01196117|OG001|Outcome|14 Days of CPAP Therapy|14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement
11028356|NCT01196117|OG000|Outcome|14 Days of Placebo Therapy, Then CPAP|14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
11028357|NCT01196117|OG001|Outcome|14 Days of CPAP Therapy|14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
11028358|NCT01196117|OG000|Outcome|CPAP>= 3 Hours Per Night|The average nightly CPAP use in the group using CPAP for >=3 hours (N=9) was 311 minutes (180-444) minutes.
11028359|NCT01196117|OG001|Outcome|CPAP<3 Hours Per Night|In the group using CPAP for <3hours (N=9), it was 33 minutes (2-85) minutes.
11028360|NCT01196117|EG000|Reported Event|14 Days of Placebo Therapy, Then CPAP|14 days of placebo therapy: 14 days of placebo therapy then 14 days of continuous positive airway pressure (CPAP) therapy
11028361|NCT01196117|EG001|Reported Event|14 Days of CPAP Therapy|14 days of continuous positive airway pressure (CPAP) therapy
11028362|NCT01196377|BG000|Baseline|Nebulized Albuterol 10mg/hr Continuous|Active control arm, 10mg/hr continuous.
11028363|NCT01196377|BG001|Baseline|10mg/hr Pulsed|Experimental 10mg/hr pulsed albuterol regimen.
11028364|NCT01196377|BG002|Baseline|25mg/hr Continuous|Experimental 25mg/hr continuous albuterol.
11028365|NCT01196377|BG003|Baseline|25mg/hr Pulsed|Experimental 25mg/hr pulsed
11028366|NCT01196377|BG004|Baseline|Total|Total of all reporting groups
11028367|NCT01196377|FG000|Participant Flow|Nebulized Albuterol 10mg/hr Continuous|Active control arm, 10mg/hr continuous.
11028368|NCT01196377|FG001|Participant Flow|10mg/hr Pulsed|Experimental 10mg/hr pulsed albuterol regimen.
11028369|NCT01196377|FG002|Participant Flow|25mg/hr Continuous|Experimental 25mg/hr continuous albuterol.
11028370|NCT01196377|FG003|Participant Flow|25mg/hr Pulsed|Experimental 25mg/hr pulsed
11028371|NCT01196377|OG000|Outcome|Nebulized Albuterol 10mg/hr Continuous|"Active control arm, 10mg/hr continuous.~Albuterol: Nebulized albuterol"
11028372|NCT01196377|OG001|Outcome|10mg/hr Pulsed|"Experimental 10mg/hr pulsed albuterol regimen.~Albuterol: Nebulized albuterol"
11028373|NCT01196377|OG002|Outcome|25mg/hr Continuous|"Experimental 25mg/hr continuous albuterol.~Albuterol: Nebulized albuterol"
11028374|NCT01196377|OG003|Outcome|25mg/hr Pulsed|"Experimental 25mg/hr pulsed~Albuterol: Nebulized albuterol"
11028375|NCT01196377|EG000|Reported Event|Nebulized Albuterol 10mg/hr Continuous|Active control arm, 10mg/hr continuous.
11028376|NCT01196377|EG001|Reported Event|10mg/hr Pulsed|Experimental 10mg/hr pulsed albuterol regimen.
11028377|NCT01196377|EG002|Reported Event|25mg/hr Continuous|Experimental 25mg/hr continuous albuterol.
11028378|NCT01196377|EG003|Reported Event|25mg/hr Pulsed|Experimental 25mg/hr pulsed
10887009|NCT00498433|FG001|Participant Flow|Aliskiren|"Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks"
11028379|NCT01196416|BG000|Baseline|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
11028380|NCT01196416|FG000|Participant Flow|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
11028381|NCT01196416|OG000|Outcome|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
11028382|NCT01196416|EG000|Reported Event|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
11028383|NCT01196429|BG000|Baseline|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
11028384|NCT01196429|BG001|Baseline|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
11028385|NCT01196429|BG002|Baseline|Total|Total of all reporting groups
10887010|NCT00498433|FG002|Participant Flow|Amlodipine|"Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.~Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks"
11028386|NCT01196429|FG000|Participant Flow|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
11028387|NCT01196429|FG001|Participant Flow|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
11028388|NCT01196429|OG000|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
11028389|NCT01196429|OG001|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
11028390|NCT01196429|OG000|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
11028391|NCT01196429|OG001|Outcome|Japan|Patients enrolled from Japan
11028392|NCT01196429|EG000|Reported Event|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
11028393|NCT01196429|EG001|Reported Event|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
11028394|NCT01196442|BG000|Baseline|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
11028395|NCT01196442|FG000|Participant Flow|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
11028396|NCT01196442|OG000|Outcome|Arm I|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~Electrical stimulation pain therapy: Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~Questionnaire administration: Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
11028397|NCT01196442|OG000|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
11028398|NCT01196442|EG000|Reported Event|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
11028399|NCT01196533|BG000|Baseline|Non Invasive Monitoring|single group of hospitalized cardiovascular patients
11028400|NCT01196533|FG000|Participant Flow|Non Invasive Monitoring|"Single group of hospitalized cardiovascular patients.~Non invasive peripheral blood monitoring: non invasive monitoring"
11028401|NCT01196533|OG000|Outcome|Non Invasive Monitoring|single group of hospitalized cardiovascular patients
11028402|NCT01196533|EG000|Reported Event|Non Invasive Monitoring|single group of hospitalized cardiovascular patients
11028403|NCT01196741|BG000|Baseline|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
11028404|NCT01196741|BG001|Baseline|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
11028405|NCT01196741|BG002|Baseline|Total|Total of all reporting groups
11028406|NCT01196741|FG000|Participant Flow|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
11028407|NCT01196741|FG001|Participant Flow|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
11028408|NCT01196741|OG000|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
11028409|NCT01196741|OG001|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
11028410|NCT01196741|EG000|Reported Event|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
11028411|NCT01196741|EG001|Reported Event|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
11028412|NCT01196793|BG000|Baseline|Febrile Children, Age 3 m to 5 y|3 month to 5 years old children with febrile illness
11028413|NCT01196793|FG000|Participant Flow|Febrile Children, Age 3 m to 5 y|3 month to 5 years old children with febrile illness
11028414|NCT01196793|OG000|Outcome|Febrile Children, Age 3 m to 5 y|3 month to 5 years children with febrile
11028415|NCT01196793|EG000|Reported Event|Febrile Children, Age 3 m to 5 y|3 month to 5 years old children with febrile
11028416|NCT01196819|BG000|Baseline|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
11028417|NCT01196819|BG001|Baseline|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
11028418|NCT01196819|BG002|Baseline|Total|Total of all reporting groups
11028419|NCT01196819|FG000|Participant Flow|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
11028420|NCT01196819|FG001|Participant Flow|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
11028421|NCT01196819|OG000|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
11028422|NCT01196819|OG001|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
11028423|NCT01196819|EG000|Reported Event|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
11028424|NCT01196819|EG001|Reported Event|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
11028425|NCT01196871|BG000|Baseline|Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
11028426|NCT01196871|BG001|Baseline|Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
11028427|NCT01196871|BG002|Baseline|Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
11028428|NCT01196871|BG003|Baseline|Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
11028429|NCT01196871|BG004|Baseline|Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
11028430|NCT01196871|BG005|Baseline|Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
11028431|NCT01196871|BG006|Baseline|Total|Total of all reporting groups
11028432|NCT01196871|FG000|Participant Flow|Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat hydrochloride (HCl) (migalastat) 2 hours (hr) before initiation of an intravenous (IV) infusion of 0.5 mg/kg mg/kg agalsidase beta.
11028433|NCT01196871|FG001|Participant Flow|Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
11028434|NCT01196871|FG002|Participant Flow|Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
11028435|NCT01196871|FG003|Participant Flow|Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450 mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
11028436|NCT01196871|FG004|Participant Flow|Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450 mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
11028437|NCT01196871|FG005|Participant Flow|Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450 mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
11028438|NCT01196871|OG000|Outcome|Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
11028439|NCT01196871|OG001|Outcome|Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
11028440|NCT01196871|OG002|Outcome|Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)|Stage 1: This arm consisted of 3 sequential treatment periods (Period 1 - Period 3). A single 150-mg oral dose (1 capsule) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
11028441|NCT01196871|OG003|Outcome|Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
11028442|NCT01196871|OG004|Outcome|Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 × 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
11028443|NCT01196871|OG005|Outcome|Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)|Stage 2: This arm consisted of 2 sequential treatment periods (Period 1, Period 2). A single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
11028444|NCT01196871|EG000|Reported Event|Stage 1 Pd 1: 0.5 mg/kg Agal-B (Arm 1)|Period 1 of Stage 1 consisted of IV administration of 0.5 mg/kg agalsidase beta.
11028445|NCT01196871|EG001|Reported Event|Stage 1 Pd 2: 150 mg Mig Before 0.5 mg/kg Agal-B (Arm 1)|Period 2 of Stage 1 consisted of administration of a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 0.5 mg/kg agalsidase beta.
11028446|NCT01196871|EG002|Reported Event|Stage 1 Pd 3: 150 mg Mig (Arm 1)|Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
11028447|NCT01196871|EG003|Reported Event|Stage 1 Pd 1: 1.0 mg/kg Agal-B (Arm 2)|Period 1 of Stage 1 consisted of IV administration of 1.0 mg/kg agalsidase beta.
11028448|NCT01196871|EG004|Reported Event|Stage 1 Pd 2: 150 mg Mig Before 1.0 mg/kg Agal-B (Arm 2)|Period 2 of Stage 1 consisted of administration of a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 1.0 mg/kg agalsidase beta.
11028449|NCT01196871|EG005|Reported Event|Stage 1 Pd 3: 150 mg Mig (Arm 2)|Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
11028450|NCT01196871|EG006|Reported Event|Stage 1 Pd 1: 0.2 mg/kg Agal-A (Arm 3)|Period 1 of Stage 1 consisted of IV administration of 0.2 mg/kg agalsidase alfa.
11028451|NCT01196871|EG007|Reported Event|Stage 1 Pd 2: 150 mg Mig Before 0.2 mg/kg Agal-A (Arm 3)|Period 2 of Stage 1 consisted of administration a single 150-mg oral dose of migalastat HCl 2 hr before initiation of an IV infusion of 0.2 mg/kg agalsidase alfa.
11028452|NCT01196871|EG008|Reported Event|Stage 1 Pd 3: 150 mg Mig (Arm 3)|Period 3 of Stage 1 consisted of a single 150-mg oral dose of migalastat HCl.
11028453|NCT01196871|EG009|Reported Event|Stage 2 Pd 1: 0.5 mg/kg Agal-B (Arm 4)|Period 1 of Stage 2 consisted of IV administration of 0.5 mg/kg agalsidase beta.
11028454|NCT01196871|EG010|Reported Event|Stage 2 Pd 2: 450 mg Mig Before 0.5 mg/kg Agal-B (Arm 4)|Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 0.5 mg/kg agalsidase beta.
11028455|NCT01196871|EG011|Reported Event|Stage 2 Pd 1: 1.0 mg/kg Agal-B (Arm 5)|Period 1 of Stage 2 consisted of IV administration of 0.5 mg/kg agalsidase beta.
11028456|NCT01196871|EG012|Reported Event|Stage 2 Pd 2: 450 Mig Before 1.0 mg/kg Agal-B (Arm 5)|Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 1.0 mg/kg agalsidase beta.
11028457|NCT01196871|EG013|Reported Event|Stage 2 Pd 1: 0.2 mg/kg Agal-A (Arm 6)|Period 1 of Stage 2 consisted of IV administration of 0.2 mg/kg agalsidase alfa.
11028458|NCT01196871|EG014|Reported Event|Stage 2 Pd 2: 450 Mig Before 0.2 mg/kg Agal-A (Arm 6)|Period 2 of Stage 2 consisted of a single 450-mg oral dose (3 x 150-mg capsules) of migalastat HCl 2 hr before IV administration of 0.2 mg/kg agalsidase alfa.
11028459|NCT01196923|BG000|Baseline|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants.
11028460|NCT01196923|FG000|Participant Flow|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
11028461|NCT01196923|OG000|Outcome|HeartLight Acutely Isolated Pulmonary Veins|
11028462|NCT01196923|EG000|Reported Event|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
11028463|NCT01196975|BG000|Baseline|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11028464|NCT01196975|BG001|Baseline|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028465|NCT01196975|BG002|Baseline|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028466|NCT01196975|BG003|Baseline|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028467|NCT01196975|BG004|Baseline|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028468|NCT01196975|BG005|Baseline|Total|Total of all reporting groups
11028469|NCT01196975|FG000|Participant Flow|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028470|NCT01196975|FG001|Participant Flow|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028471|NCT01196975|FG002|Participant Flow|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028472|NCT01196975|FG003|Participant Flow|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028473|NCT01196975|FG004|Participant Flow|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028474|NCT01196975|OG000|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028475|NCT01196975|OG001|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028476|NCT01196975|OG002|Outcome|Yamagata Strain FluLaval Group|Yamagata Strain FluLaval Group - Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028477|NCT01196975|OG000|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028478|NCT01196975|OG001|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028479|NCT01196975|OG002|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028480|NCT01196975|OG003|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028481|NCT01196975|OG004|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028482|NCT01196975|OG005|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028483|NCT01196975|OG000|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028484|NCT01196975|OG001|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028485|NCT01196975|OG002|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028486|NCT01196975|OG003|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028487|NCT01196975|OG004|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028488|NCT01196975|OG005|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028489|NCT01196975|OG000|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028490|NCT01196975|OG001|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028491|NCT01196975|OG002|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028492|NCT01196975|OG003|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028493|NCT01196975|OG004|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028494|NCT01196975|OG002|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11028495|NCT01196975|OG003|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11028496|NCT01196975|OG000|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028497|NCT01196975|OG002|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11028498|NCT01196975|OG005|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11028499|NCT01196975|OG005|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11028500|NCT01196975|OG002|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028501|NCT01196975|OG003|Outcome|Victoria Strain FluLaval|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11148959|NCT01868022|OG005|Outcome|20 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11028502|NCT01196975|EG000|Reported Event|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.dominant arm.
11028503|NCT01196975|EG001|Reported Event|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028504|NCT01196975|EG002|Reported Event|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028505|NCT01196975|EG003|Reported Event|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028506|NCT01196975|EG004|Reported Event|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028507|NCT01196988|BG000|Baseline|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028508|NCT01196988|BG001|Baseline|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028509|NCT01196988|BG002|Baseline|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028510|NCT01196988|BG003|Baseline|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028511|NCT01196988|BG004|Baseline|Total|Total of all reporting groups
11028512|NCT01196988|FG000|Participant Flow|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028513|NCT01196988|FG001|Participant Flow|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028514|NCT01196988|FG002|Participant Flow|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028515|NCT01196988|FG003|Participant Flow|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028516|NCT01196988|OG000|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028517|NCT01196988|OG001|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028518|NCT01196988|OG002|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028519|NCT01196988|OG003|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11148960|NCT01868022|OG006|Outcome|10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11028520|NCT01196988|OG000|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028521|NCT01196988|EG000|Reported Event|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028522|NCT01196988|EG001|Reported Event|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028523|NCT01196988|EG002|Reported Event|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028524|NCT01196988|EG003|Reported Event|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
11028525|NCT01197300|BG000|Baseline|Core Treatment Zoledronic Acid|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11028526|NCT01197300|BG001|Baseline|Core Treatment: Placebo|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11028527|NCT01197300|BG002|Baseline|Total|Total of all reporting groups
11028528|NCT01197300|FG000|Participant Flow|Core Treatment Zoledronic Acid|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11028529|NCT01197300|FG001|Participant Flow|Core Treatment: Placebo|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11028530|NCT01197300|OG000|Outcome|Core Treatment Zoledronic Acid|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11028531|NCT01197300|OG001|Outcome|Core Treatment: Placebo|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11028532|NCT01197300|EG000|Reported Event|Core Treatment Zoledronic Acid|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11028533|NCT01197300|EG001|Reported Event|Core Treatment Placebo|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11028534|NCT01197326|BG000|Baseline|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
11028535|NCT01197326|BG001|Baseline|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
11028536|NCT01197326|BG002|Baseline|Total|Total of all reporting groups
11028537|NCT01197326|FG000|Participant Flow|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
11028538|NCT01197326|FG001|Participant Flow|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
11028539|NCT01197326|OG000|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
11028540|NCT01197326|OG001|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
11028541|NCT01197326|OG000|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
11028542|NCT01197326|OG001|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
11028543|NCT01197326|EG000|Reported Event|Patients Who Triggered MET/RRT Calls Prior to the Use of MP5|Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor
11028544|NCT01197326|EG001|Reported Event|Patients Who Triggered MET/RRT Calls After the Use of MP5|Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor
11028545|NCT01197378|BG000|Baseline|Cysteamine Bitartrate|Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
11028546|NCT01197378|FG000|Participant Flow|Cysteamine Bitartrate|Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
11028547|NCT01197378|OG000|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
11028548|NCT01197378|EG000|Reported Event|Cysteamine Bitartrate|Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
11028549|NCT01197417|BG000|Baseline|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
11028550|NCT01197417|BG001|Baseline|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
11028551|NCT01197417|BG002|Baseline|Total|Total of all reporting groups
11028552|NCT01197417|FG000|Participant Flow|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
11028553|NCT01197417|FG001|Participant Flow|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
11028554|NCT01197417|OG000|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
11028555|NCT01197417|OG001|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
11028556|NCT01197417|EG000|Reported Event|Magnesium Group|Intravenous Magnesium Sulfate Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
11028557|NCT01197417|EG001|Reported Event|Placebo Group|Normal Saline placebo Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
11028558|NCT01197456|BG000|Baseline|Exposed/Chemotherapy|Breast cancer patients who will undergo chemotherapy
11028559|NCT01197456|BG001|Baseline|Unexposed|Breast cancer patients who will not undergo chemotherapy
11028560|NCT01197456|BG002|Baseline|Total|Total of all reporting groups
11028561|NCT01197456|FG000|Participant Flow|Exposed/Chemotherapy|Breast cancer patients who will undergo chemotherapy
11028562|NCT01197456|FG001|Participant Flow|Unexposed|Breast cancer patients who will not undergo chemotherapy
11028563|NCT01197456|OG000|Outcome|Exposed/Chemotherapy|Breast cancer patients who will undergo chemotherapy
11028564|NCT01197456|OG001|Outcome|Unexposed|Breast cancer patients who will not undergo chemotherapy
11028565|NCT01197456|EG000|Reported Event|Exposed/Chemotherapy|Breast cancer patients who will undergo chemotherapy
11028566|NCT01197456|EG001|Reported Event|Unexposed|Breast cancer patients who will not undergo chemotherapy
11028567|NCT01197495|BG000|Baseline|Treatment|Juvederm(R) Ultra XC Injectable Gel
11028568|NCT01197495|BG001|Baseline|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
11028569|NCT01197495|BG002|Baseline|Total|Total of all reporting groups
11028570|NCT01197495|FG000|Participant Flow|Treatment|Juvederm(R) Ultra XC Injectable Gel
11028571|NCT01197495|FG001|Participant Flow|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
11028572|NCT01197495|OG000|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
11028573|NCT01197495|OG001|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
11028574|NCT01197495|EG000|Reported Event|Onset Prior to Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
11028575|NCT01197495|EG001|Reported Event|Onset After Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
11028576|NCT01197508|BG000|Baseline|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
11028577|NCT01197508|BG001|Baseline|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
11028578|NCT01197508|BG002|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
11028579|NCT01197508|BG003|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11028580|NCT01197508|BG004|Baseline|Total|Total of all reporting groups
11028581|NCT01197508|FG000|Participant Flow|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
11028582|NCT01197508|FG001|Participant Flow|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
11028583|NCT01197508|FG002|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
11028584|NCT01197508|FG003|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11028585|NCT01197508|OG000|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
11028586|NCT01197508|OG001|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
11028587|NCT01197508|OG002|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
11028588|NCT01197508|OG003|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
11028589|NCT01197508|EG000|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
11028590|NCT01197508|EG001|Reported Event|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
11028591|NCT01197508|EG002|Reported Event|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
11028592|NCT01197508|EG003|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
11028593|NCT01197521|BG000|Baseline|FOSTA 100 MG BID PO|Dosing Group A
11028594|NCT01197521|BG001|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028595|NCT01197521|BG002|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
11028596|NCT01197521|BG003|Baseline|Total|Total of all reporting groups
11028597|NCT01197521|FG000|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
11028598|NCT01197521|FG001|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028599|NCT01197521|FG002|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
11028600|NCT01197521|OG000|Outcome|FOSTA 100 MG BID PO|Dosing Group A
11028601|NCT01197521|OG001|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028602|NCT01197521|OG002|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
11028603|NCT01197521|OG000|Outcome|FOSTA 100 MG BID (Combined)|Dosing Group A and B combined
11028604|NCT01197521|OG001|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
11028605|NCT01197521|EG000|Reported Event|FOSTA 100 MG BID|Dosing Group A
11028606|NCT01197521|EG001|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
11028607|NCT01197521|EG002|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
11028608|NCT01197521|EG003|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
11028609|NCT01197534|BG000|Baseline|FOSTA 100 MG BID PO|Dosing Group A
11028610|NCT01197534|BG001|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028611|NCT01197534|BG002|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
11028612|NCT01197534|BG003|Baseline|Total|Total of all reporting groups
11028613|NCT01197534|FG000|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
11028614|NCT01197534|FG001|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028615|NCT01197534|FG002|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
11028616|NCT01197534|OG000|Outcome|FOSTA 100 MG BID PO|Dosing Group A
11028617|NCT01197534|OG001|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028618|NCT01197534|OG002|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
11028619|NCT01197534|OG000|Outcome|FOSTA 100 MG BID PO (Combined)|Dosing Group A and B combined
11028620|NCT01197534|OG001|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
11028621|NCT01197534|EG000|Reported Event|FOSTA 100 MG BID|Dosing Group A
11028622|NCT01197534|EG001|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
11028623|NCT01197534|EG002|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
11028624|NCT01197534|EG003|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
11028625|NCT01197547|BG000|Baseline|Genesys HTA|"Genesys HTA Endometrial Ablation~Genesys HTA: Genesys HTA Endometrial Ablation"
11028626|NCT01197547|FG000|Participant Flow|Genesys HTA|Genesys HTA Endometrial Ablation
11028627|NCT01197547|OG000|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
11028628|NCT01197547|EG000|Reported Event|Genesys HTA|Genesys HTA Endometrial Ablation
11028629|NCT01197560|BG000|Baseline|Lenalidomide|Participants received lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may have been increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
11028630|NCT01197560|BG001|Baseline|Investigators Choice (IC)|Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal. Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only) Etoposide doses: 100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles
11028631|NCT01197560|BG002|Baseline|Total|Total of all reporting groups
11028632|NCT01197560|FG000|Participant Flow|Lenalidomide|Participants received lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may have been increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
11028633|NCT01197560|FG001|Participant Flow|Investigators Choice (Control Arm)|Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal. Participants with documented progressive disease had the option to receive crossover lenalidomide at the same dosage as participants randomized to lenalidomide.
11028634|NCT01197560|OG000|Outcome|Lenalidomide|Participants received lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may have been increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
11028635|NCT01197560|OG001|Outcome|Investigators Choice (IC)|Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal. Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only) Etoposide doses: 100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles
11028636|NCT01197560|OG001|Outcome|Investigators Choice (Control Arm)|Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal. Participants with documented progressive disease had the option to receive crossover lenalidomide at the same dosage as participants randomized to lenalidomide.
11028637|NCT01197560|EG000|Reported Event|Lenalidomide|Participants received lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may have been increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
11028638|NCT01197560|EG001|Reported Event|Investigator's Choice|Investigator's Choice
11028639|NCT01197573|BG000|Baseline|Standard DCD Liver Transplant|Standard method of liver transplant utilizing a DCD organ
11028640|NCT01197573|BG001|Baseline|rTPA Treatment - Liver|"Ex-vivo treatment of liver donated after cardiac death (DCD)with rTPA~rTPA Treatment: Ex-vivo treatment of DCD liver with rTPA (recombinant tissue plasminogen activator)prior to implantation"
11028641|NCT01197573|BG002|Baseline|rTPA Treatment - Kidney|"Ex-vivo treatment of kidney donated after cardiac death (DCD)with rTPA~rTPA Treatment: Ex-vivo treatment of DCD kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation"
11028642|NCT01197573|BG003|Baseline|Standard DCD Kidney Transplant|Standard method of kidney transplant utilizing a DCD organ
11028643|NCT01197573|BG004|Baseline|Total|Total of all reporting groups
11028644|NCT01197573|FG000|Participant Flow|Standard DCD Liver Transplant|Standard method of liver transplant utilizing a DCD organ
11028645|NCT01197573|FG001|Participant Flow|rTPA Treatment - Liver|"Ex-vivo treatment of liver donated after cardiac death (DCD)with rTPA~rTPA Treatment: Ex-vivo treatment of DCD liver with rTPA (recombinant tissue plasminogen activator)prior to implantation"
11028646|NCT01197573|FG002|Participant Flow|Standard DCD Kidney Transplant|Standard method of kidney transplant utilizing a DCD organ
11028647|NCT01197573|FG003|Participant Flow|rTPA Treatment - Kidney|"Ex-vivo treatment of kidney donated after cardiac death (DCD)with rTPA~rTPA Treatment: Ex-vivo treatment of DCD kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation"
11028648|NCT01197573|OG000|Outcome|rTPA Treatment - Kidney|"Ex-vivo treatment of kidney donated after cardiac death (DCD)with rTPA~rTPA Treatment: Ex-vivo treatment of DCD kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation"
11028649|NCT01197573|OG001|Outcome|Standard DCD Kidney Transplant|Standard method of kidney transplant utilizing a DCD organ
11028650|NCT01197573|OG000|Outcome|Standard DCD Liver Transplant|Standard method of liver transplant utilizing a DCD organ
11028651|NCT01197573|OG001|Outcome|rTPA Treatment|"Ex-vivo treatment of liver donated after cardiac death (DCD)with rTPA~rTPA Treatment: Ex-vivo treatment of DCD liver with rTPA (recombinant tissue plasminogen activator)prior to implantation"
11028652|NCT01197573|EG000|Reported Event|Standard DCD Liver Transplant|Standard method of liver transplant utilizing a DCD organ
11028653|NCT01197573|EG001|Reported Event|rTPA Treatment - Liver|"Ex-vivo treatment of liver donated after cardiac death (DCD)with rTPA~rTPA Treatment: Ex-vivo treatment of DCD liver with rTPA (recombinant tissue plasminogen activator)prior to implantation"
11028654|NCT01197573|EG002|Reported Event|rTPA Treatment - Kidney|"Ex-vivo treatment of kidney donated after cardiac death (DCD)with rTPA~rTPA Treatment: Ex-vivo treatment of DCD kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation"
11028655|NCT01197573|EG003|Reported Event|Standard DCD Kidneytransplant|Standard method of kidney transplant utilizing a DCD organ
11028656|NCT01197612|BG000|Baseline|Single Arm; Nostrils as Experimental and Comparator|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
11028657|NCT01197612|FG000|Participant Flow|Single Arm; Nostrils as Experimental and Comparator|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
11028658|NCT01197612|OG000|Outcome|Treated Nostril (Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
11028659|NCT01197612|OG001|Outcome|Untreated Nostril (no Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
11028660|NCT01197612|OG001|Outcome|Placebo Treated Nostril (no Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
11028661|NCT01197612|OG001|Outcome|Placebo/Untreated Nostril (no Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
11028662|NCT01197612|EG000|Reported Event|Single Arm; Nostrils as Experimental and Comparator|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
11028663|NCT01197755|BG000|Baseline|FOSTA 100 MG BID PO|Dosing Group A
11028664|NCT01197755|BG001|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028665|NCT01197755|BG002|Baseline|PLACEBO PO|Dosing Group C
11028666|NCT01197755|BG003|Baseline|Total|Total of all reporting groups
11028667|NCT01197755|FG000|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
11028668|NCT01197755|FG001|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028669|NCT01197755|FG002|Participant Flow|PLACEBO PO|Dosing Group C
11028670|NCT01197755|OG000|Outcome|FOSTA 100 MG BID PO|Dosing Group A
11028671|NCT01197755|OG001|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028672|NCT01197755|OG002|Outcome|PLACEBO PO|Dosing Group C
11028673|NCT01197755|OG000|Outcome|PLACEBO PO|Dosing Group C
11028674|NCT01197755|OG001|Outcome|Dosing Group A and B Combined PO|Fostamatinib 100 mg BID (combined)
11028675|NCT01197755|EG000|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
11028676|NCT01197755|EG001|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11028677|NCT01197755|EG002|Reported Event|PLACEBO PO|Dosing Group C
11028678|NCT01197794|BG000|Baseline|AZD1981 400 mg|AZD1981 400 mg twice daily
11028679|NCT01197794|BG001|Baseline|AZD1981 200 mg|AZD1981 200 mg once daily
11028680|NCT01197794|BG002|Baseline|AZD1981 100 mg|AZD1981 100 mg twice daily
11028681|NCT01197794|BG003|Baseline|AZD1981 80 mg|AZD1981 80 mg once daily
11028682|NCT01197794|BG004|Baseline|AZD1981 40 mg|AZD1981 40 mg twice daily
11028683|NCT01197794|BG005|Baseline|AZD1981 10 mg|AZD1981 10 mg twice daily
11028684|NCT01197794|BG006|Baseline|Placebo|Placebo
11028685|NCT01197794|BG007|Baseline|Total|Total of all reporting groups
11028686|NCT01197794|FG000|Participant Flow|AZD1981 400 mg|AZD1981 400 mg twice daily
11028687|NCT01197794|FG001|Participant Flow|AZD1981 200 mg|AZD1981 200 mg once daily
11028688|NCT01197794|FG002|Participant Flow|AZD1981 100 mg|AZD1981 100 mg twice daily
11028689|NCT01197794|FG003|Participant Flow|AZD1981 80 mg|AZD1981 80 mg once daily
11028690|NCT01197794|FG004|Participant Flow|AZD1981 40 mg|AZD1981 40 mg twice daily
11028691|NCT01197794|FG005|Participant Flow|AZD1981 10 mg|AZD1981 10 mg twice daily
11028692|NCT01197794|FG006|Participant Flow|Placebo|Placebo
11028693|NCT01197794|OG000|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
11028694|NCT01197794|OG001|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
11028695|NCT01197794|OG002|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
11028696|NCT01197794|OG003|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
11028697|NCT01197794|OG004|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
11028698|NCT01197794|OG005|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
11028699|NCT01197794|OG006|Outcome|Arm7-Placebo|Placebo
11028700|NCT01197794|OG006|Outcome|Arm 7-Placebo|Placebo
11028701|NCT01197794|EG000|Reported Event|AZD1981 400 mg|AZD1981 400 mg twice daily
11028702|NCT01197794|EG001|Reported Event|AZD1981 200 mg|AZD1981 200 mg once daily
11028703|NCT01197794|EG002|Reported Event|AZD1981 100 mg|AZD1981 100 mg twice daily
11028704|NCT01197794|EG003|Reported Event|AZD1981 80 mg|AZD1981 80 mg once daily
11028705|NCT01197794|EG004|Reported Event|AZD1981 40 mg|AZD1981 40 mg twice daily
11028706|NCT01197794|EG005|Reported Event|AZD1981 10 mg|AZD1981 10 mg twice daily
11028707|NCT01197794|EG006|Reported Event|Placebo|Placebo
11028708|NCT01197833|BG000|Baseline|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
11028709|NCT01197833|BG001|Baseline|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
11028710|NCT01197833|BG002|Baseline|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
11028711|NCT01197833|BG003|Baseline|Total|Total of all reporting groups
11028712|NCT01197833|FG000|Participant Flow|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
11028713|NCT01197833|FG001|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
11028714|NCT01197833|FG002|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
11028715|NCT01197833|OG000|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
11028716|NCT01197833|OG001|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
11028717|NCT01197833|OG002|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
11028718|NCT01197833|EG000|Reported Event|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
11028719|NCT01197833|EG001|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
11028720|NCT01197833|EG002|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
11028721|NCT01197898|BG000|Baseline|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
11028722|NCT01197898|BG001|Baseline|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
11028723|NCT01197898|BG002|Baseline|Total|Total of all reporting groups
11028724|NCT01197898|FG000|Participant Flow|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
11028725|NCT01197898|FG001|Participant Flow|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
11028726|NCT01197898|OG000|Outcome|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
11028727|NCT01197898|OG001|Outcome|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
11028728|NCT01197898|EG000|Reported Event|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
11028729|NCT01197898|EG001|Reported Event|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
11028730|NCT01197911|BG000|Baseline|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
11028731|NCT01197911|BG001|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
11028732|NCT01197911|BG002|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
11028733|NCT01197911|BG003|Baseline|Total|Total of all reporting groups
11028734|NCT01197911|FG000|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
11028735|NCT01197911|FG001|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
11028736|NCT01197911|FG002|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
11028737|NCT01197911|OG000|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
11028738|NCT01197911|OG001|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
11028739|NCT01197911|OG002|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
11028740|NCT01197911|OG000|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 mcg tablet
11028741|NCT01197911|EG000|Reported Event|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
11028742|NCT01197911|EG001|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
11028743|NCT01197911|EG002|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
11066369|NCT01391832|OG001|Outcome|Active rTMS|"Active Repetitive Transcranial Magnet Stimulation treatment~Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex The rTMS coil will be placed over the right prefrontal scalp region, targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the active mode. Alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds (1 HZ at 110% of motor-threshold).~Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered."
11066370|NCT01391832|EG000|Reported Event|Sham rTMS|"Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)~Repetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.~Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma."
11066371|NCT01391832|EG001|Reported Event|Active rTMS|"Active Repetitive Transcranial Magnet Stimulation treatment~Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex~Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.~Repetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil was be placed over over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46) and stimulation provided at 1 Hz (1.5-2.0 Tesla strength, 100 - 300 microseconds."
11066372|NCT01391858|BG000|Baseline|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
11066373|NCT01391858|BG001|Baseline|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
11066374|NCT01391858|BG002|Baseline|Total|Total of all reporting groups
11066375|NCT01391858|FG000|Participant Flow|Pregabalin|Pregabalin 300 mg 1-2 hrs. before the surgery and then 150 mg twice a day for 14 days
11066376|NCT01391858|FG001|Participant Flow|Placebo|Placebo 1-2 hrs. before the surgery and then twice daily for 14 days
11066377|NCT01391858|OG000|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
11066378|NCT01391858|OG001|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
11066379|NCT01391858|EG000|Reported Event|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
11066380|NCT01391858|EG001|Reported Event|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
11066381|NCT01392053|BG000|Baseline|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
11066382|NCT01392053|BG001|Baseline|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
11066383|NCT01392053|BG002|Baseline|Total|Total of all reporting groups
11066384|NCT01392053|FG000|Participant Flow|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
11066385|NCT01392053|FG001|Participant Flow|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
11066386|NCT01392053|OG000|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
11066387|NCT01392053|OG001|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
11028744|NCT01198002|BG000|Baseline|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028745|NCT01198002|BG001|Baseline|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028746|NCT01198002|BG002|Baseline|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028747|NCT01198002|BG003|Baseline|Total|Total of all reporting groups
11028748|NCT01198002|FG000|Participant Flow|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W).~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028749|NCT01198002|FG001|Participant Flow|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028750|NCT01198002|FG002|Participant Flow|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028751|NCT01198002|OG000|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
11028752|NCT01198002|OG001|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
11028753|NCT01198002|OG002|Outcome|Placebo|"Placebo Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
11066388|NCT01392053|EG000|Reported Event|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
11066389|NCT01392053|EG001|Reported Event|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
11028754|NCT01198002|OG000|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028755|NCT01198002|OG001|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028756|NCT01198002|OG002|Outcome|Placebo|"Placebo Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028757|NCT01198002|OG002|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
11028758|NCT01198002|OG002|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028759|NCT01198002|OG000|Outcome|LY2127399|"A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 100 weeks or a loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 100 weeks. At Weeks 16 and 52, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 100-week treatment period or 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
11028760|NCT01198002|EG000|Reported Event|LY 120 mg Q4W, Randomized Treatment Period 1|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
11028761|NCT01198002|EG001|Reported Event|LY 90 mg Q2W, Randomized Treatment Period 1|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
11028762|NCT01198002|EG002|Reported Event|Placebo, Randomized Treatment Period 1|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
11028763|NCT01198002|EG003|Reported Event|LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Rescue Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR."
11148961|NCT01868022|OG007|Outcome|15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11028764|NCT01198002|EG004|Reported Event|LY 90 mg Q2W, Rescue Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 16 weeks during Treatment Period 1.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR."
11028765|NCT01198002|EG005|Reported Event|Placebo to LY 90 mg Q2W (Week 16), Rescue Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR."
11028766|NCT01198002|EG006|Reported Event|LY 120 mg Q4W, Treatment Period 2|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
11028767|NCT01198002|EG007|Reported Event|LY 90 mg Q2W, Treatment Period 2|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~At Week 52, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
11028768|NCT01198002|EG008|Reported Event|Placebo to LY 120 mg Q4W (Week 52), Treatment Period 2|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~At Week 52, Week 16 responders were randomized to receive 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
11028769|NCT01198002|EG009|Reported Event|Placebo to LY 90 mg Q2W (Week 52), Treatment Period 2|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~At Week 52, Week 16 responders were randomized to receive 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q4W for the rest of the Treatment Period 2~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
11028770|NCT01198002|EG010|Reported Event|LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Treatment Period 2|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, Week 16 NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
11028771|NCT01198002|EG011|Reported Event|Placebo to LY 90 mg Q2W (Week 16), Treatment Period 2|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.~At Week 16, Week 16 NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
11028772|NCT01198002|EG012|Reported Event|LY 120 mg Q4W, Follow-up Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11066390|NCT01392183|BG000|Baseline|Temsirolimus (Control Group)|Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.
11066391|NCT01392183|BG001|Baseline|Pazopanib (Treatment Group)|Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.
11066392|NCT01392183|BG002|Baseline|Total|Total of all reporting groups
11225837|NCT02370511|EG002|Reported Event|Valve-in-Valve|"Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).~Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position."
11225838|NCT02370537|BG000|Baseline|Low FEC (EPANOVA® and OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
11028773|NCT01198002|EG013|Reported Event|LY 90 mg Q2W, Follow-up Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~At Week 52, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11028774|NCT01198002|EG014|Reported Event|Placebo to LY 120 mg Q4W (Week 52), Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~At Week 52, Week 16 responders were randomized to receive 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11028775|NCT01198002|EG015|Reported Event|Placebo to LY 90 mg Q2W (Week 52), Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~At Week 52, Week 16 responders were randomized to receive 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q4W for the rest of the Treatment Period 2~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11028776|NCT01198002|EG016|Reported Event|LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, Week 16 NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11028777|NCT01198002|EG017|Reported Event|Placebo to LY 90 mg Q2W (Week 16), Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.~At Week 16, Week 16 NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11028778|NCT01198002|EG018|Reported Event|Placebo, Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~The Post-Treatment Follow-Up Period started after Week 52 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11028779|NCT01198028|BG000|Baseline|Erlotinib|150 mg once daily by mouth.
11028780|NCT01198028|FG000|Participant Flow|Erlotinib|150 mg once daily by mouth.
11028781|NCT01198028|OG000|Outcome|Erlotinib|150 mg once daily by mouth.
11028782|NCT01198028|EG000|Reported Event|Erlotinib|150 mg once daily by mouth.
11028783|NCT01198132|BG000|Baseline|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
11028784|NCT01198132|BG001|Baseline|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
11028785|NCT01198132|BG002|Baseline|Total|Total of all reporting groups
11028786|NCT01198132|FG000|Participant Flow|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
11028787|NCT01198132|FG001|Participant Flow|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
11028788|NCT01198132|OG000|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
11028789|NCT01198132|OG001|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
11028790|NCT01198132|OG001|Outcome|Rebif +Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
11028791|NCT01198132|OG001|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with sub-cutaneous injection of Rebif 44 mcg 3 times weekly.
11028792|NCT01198132|EG000|Reported Event|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
11028793|NCT01198132|EG001|Reported Event|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
11028794|NCT01198145|BG000|Baseline|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
11028795|NCT01198145|BG001|Baseline|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.>~> placebo: Given orally"
11028796|NCT01198145|BG002|Baseline|Total|Total of all reporting groups
11028797|NCT01198145|FG000|Participant Flow|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
11028798|NCT01198145|FG001|Participant Flow|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.~>~> placebo: Given orally"
11028799|NCT01198145|OG000|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
11028800|NCT01198145|OG001|Outcome|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.~>~> placebo: Given orally"
11028801|NCT01198145|OG001|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
11028802|NCT01198145|EG000|Reported Event|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
11028803|NCT01198145|EG001|Reported Event|Arm II: Placebo|placebo: Given orally
11028804|NCT01198158|BG000|Baseline|Arm I (Everolimus)|Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.
11028805|NCT01198158|BG001|Baseline|Arm II (Everolimus With Bevacizumab)|Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
11028806|NCT01198158|BG002|Baseline|Total|Total of all reporting groups
11028807|NCT01198158|FG000|Participant Flow|Arm I (Everolimus)|Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.
11028808|NCT01198158|FG001|Participant Flow|Arm II (Everolimus With Bevacizumab)|Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
11028809|NCT01198158|OG000|Outcome|Arm I (Everolimus)|Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.
11028810|NCT01198158|OG001|Outcome|Arm II (Everolimus With Bevacizumab)|Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
11028811|NCT01198158|EG000|Reported Event|Arm I (Everolimus)|Patients receive everolimus 10mg daily orally plus intravenous placebo on day 1 and 15 (control arm) in a 28 day cycle.
11028812|NCT01198158|EG001|Reported Event|Arm II (Everolimus With Bevacizumab)|Patients receive everolimus 10mg daily orally plus intravenous bevacizumab 10mg/kg intravenously on day 1 and 15 (experimental arm) in a 28 day cycle.
11028813|NCT01198275|BG000|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
11028814|NCT01198275|BG001|Baseline|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
11028815|NCT01198275|BG002|Baseline|Total|Total of all reporting groups
11028816|NCT01198275|FG000|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
11028817|NCT01198275|FG001|Participant Flow|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
11028818|NCT01198275|OG000|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
11028819|NCT01198275|OG001|Outcome|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
11028820|NCT01198275|EG000|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
11028821|NCT01198275|EG001|Reported Event|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
11028822|NCT01198327|BG000|Baseline|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
11028823|NCT01198327|FG000|Participant Flow|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
11028824|NCT01198327|OG000|Outcome|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
11028825|NCT01198327|OG000|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for Central retinal vein occlusion.
11028826|NCT01198327|OG001|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
11028827|NCT01198327|OG000|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for central retinal vein occlusion.
11028828|NCT01198327|EG000|Reported Event|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
11028829|NCT01198366|BG000|Baseline|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
11028830|NCT01198366|BG001|Baseline|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028831|NCT01198366|BG002|Baseline|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028832|NCT01198366|BG003|Baseline|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11148962|NCT01868022|OG008|Outcome|20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11028833|NCT01198366|BG004|Baseline|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028834|NCT01198366|BG005|Baseline|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
11028835|NCT01198366|BG006|Baseline|Total|Total of all reporting groups
11028836|NCT01198366|FG000|Participant Flow|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
11028837|NCT01198366|FG001|Participant Flow|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028838|NCT01198366|FG002|Participant Flow|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028839|NCT01198366|FG003|Participant Flow|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028840|NCT01198366|FG004|Participant Flow|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028841|NCT01198366|FG005|Participant Flow|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
11028842|NCT01198366|OG000|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
11028843|NCT01198366|OG001|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028844|NCT01198366|OG002|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028845|NCT01198366|OG003|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028846|NCT01198366|OG004|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
11028847|NCT01198366|OG005|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
11028848|NCT01198366|EG000|Reported Event|Dose Finding - Group 1|Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.
11028849|NCT01198366|EG001|Reported Event|Dose Finding - Group 2|Subjects received two doses of AERAS-402 (1.5 x 10^10 vp) on study days 0 and 28.
11028850|NCT01198366|EG002|Reported Event|Dose Finding - Group 3|Subjects received two doses of AERAS-402 (3.0 x 10^10 vp) on study days 0 and 28.
11028851|NCT01198366|EG003|Reported Event|Dose Finding - Group 4|Subjects received two doses of AERAS-402 (1.0 x 10^11 vp) on study days 0 and 28.
11028852|NCT01198366|EG004|Reported Event|Expanded Safety Phase - Group 5|Subjects received 3 doses of AERAS-402 (1.0 X 10^11 vp) on days 0, 28 and 280.
11028853|NCT01198366|EG005|Reported Event|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo (sterile buffer) on days 0, 28 and 280.~Placebo"
11028854|NCT01198470|BG000|Baseline|TRIUMPH® Artificial Disc|"Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).~TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine."
11028855|NCT01198470|FG000|Participant Flow|TRIUMPH® Artificial Disc|"Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).~TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine."
11028856|NCT01198470|OG000|Outcome|TRIUMPH® Artificial Disc|"Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).~TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine."
11028857|NCT01198470|EG000|Reported Event|TRIUMPH® Artificial Disc|"Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).~TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine."
11028858|NCT01198509|BG000|Baseline|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
11028859|NCT01198509|BG001|Baseline|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
11028860|NCT01198509|BG002|Baseline|Rheumatoid Arthritis (RA) Randomized to no Treatment|Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.
11028861|NCT01198509|BG003|Baseline|Early RA Cross-sectional Cohort|Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
11028862|NCT01198509|BG004|Baseline|Psoriatic Arthritis (PsA)|Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
11028863|NCT01198509|BG005|Baseline|Healthy Volunteers|Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
11028864|NCT01198509|BG006|Baseline|Total|Total of all reporting groups
11028865|NCT01198509|FG000|Participant Flow|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months~N=5 (actual)"
11028866|NCT01198509|FG001|Participant Flow|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks~N=10 (actual)"
11028867|NCT01198509|FG002|Participant Flow|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
11028868|NCT01198509|FG003|Participant Flow|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
11028869|NCT01198509|FG004|Participant Flow|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
11028870|NCT01198509|FG005|Participant Flow|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
11028871|NCT01198509|OG000|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
11148963|NCT01868022|OG000|Outcome|20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11028872|NCT01198509|OG001|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
11028873|NCT01198509|OG002|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment, followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
11028874|NCT01198509|OG003|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
11028875|NCT01198509|OG004|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
11028876|NCT01198509|OG005|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
11028877|NCT01198509|OG002|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
11028878|NCT01198509|EG000|Reported Event|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
11028879|NCT01198509|EG001|Reported Event|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
11028880|NCT01198509|EG002|Reported Event|RA, PsA, Healthy|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.~Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients."
11028881|NCT01198574|BG000|Baseline|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
11028882|NCT01198574|BG001|Baseline|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
11148964|NCT01868022|OG001|Outcome|20 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11148965|NCT01868022|OG002|Outcome|15 mg/kg GSK3052230 + Pemetrexed + Carboplatin: Arm C|Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11028883|NCT01198574|BG002|Baseline|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
11028884|NCT01198574|BG003|Baseline|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
11028885|NCT01198574|BG004|Baseline|Total|Total of all reporting groups
11028886|NCT01198574|FG000|Participant Flow|Iron Group|Iron group received 60 mg of elemental iron, 2.5 mg folic acid + Placebo Vitamin A weekly
11028887|NCT01198574|FG001|Participant Flow|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Placebo iron containing 2.5 mg folic acid weekly
11028888|NCT01198574|FG002|Participant Flow|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid + 15,000 IU Vitamin A weekly
11028889|NCT01198574|FG003|Participant Flow|Placebo Group|Placebo group received 2.5 mg folic acid weekly
11028890|NCT01198574|OG000|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
11028891|NCT01198574|OG001|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
11028892|NCT01198574|OG002|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
11028893|NCT01198574|OG003|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
11028894|NCT01198574|EG000|Reported Event|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
11028895|NCT01198574|EG001|Reported Event|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
11028896|NCT01198574|EG002|Reported Event|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
11028897|NCT01198574|EG003|Reported Event|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
11028898|NCT01198587|BG000|Baseline|Outpatient Zinc Sulfate|"Outpatients with diarrhea will be randomized to Zinc Sulfate~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028899|NCT01198587|BG001|Baseline|Inpatient Zinc Sulfate|"Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc Sulfate~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028900|NCT01198587|BG002|Baseline|Outpatient Placebo|Outpatients with diarrhea will be randomized to Placebo oral capsule
11028901|NCT01198587|BG003|Baseline|Inpatient Placebo|Patients admitted to the hospital with diarrhea and dehydration will be randomized to Placebo oral capsule
11028902|NCT01198587|BG004|Baseline|Total|Total of all reporting groups
11028903|NCT01198587|FG000|Participant Flow|Outpatient Zinc Sulfate|"Outpatients with diarrhea will be randomized to either zinc or placebo to assess the effect on duration of diarrhea.~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028904|NCT01198587|FG001|Participant Flow|Inpatient Zinc Sulfate|"Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc or placebo, duration of hospitalization will be assessed.~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028905|NCT01198587|FG002|Participant Flow|Outpatient Placebo|Patient discharged randomized to Placebo Oral Capsule
11028906|NCT01198587|FG003|Participant Flow|Inpatient Placebo|Hospitalized patients randomized to Placebo oral capsule
11028907|NCT01198587|OG000|Outcome|Outpatient Zinc Sulfate|"Outpatients with diarrhea will be randomized to zinc sulfate~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028908|NCT01198587|OG001|Outcome|Inpatient Zinc Sulfate|"Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate.~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028909|NCT01198587|OG002|Outcome|Outpatient Placebo|Outpatients with diarrhea will be randomized to placebo oral capsule
11028910|NCT01198587|OG003|Outcome|Inpatient Placebo|Hospitalized patients with diarrhea and dehydration will be randomized to placebo oral capsule
11028911|NCT01198587|OG000|Outcome|Outpatient Zinc Sulfate|"Outpatients with diarrhea will be randomized to either zinc or placebo to assess the effect on duration of diarrhea.~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028912|NCT01198587|OG001|Outcome|Inpatient Zinc Sulfate|"Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc or placebo, duration of hospitalization will be assessed.~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028913|NCT01198587|OG002|Outcome|Outpatient Placebo|Outpatients with diarrhea randomized to placebo oral capsules
11028914|NCT01198587|OG003|Outcome|Inpatient Placebo|patients with diarrhea and dehydration hospitalized and randomized to placebo oral capsule
11028915|NCT01198587|OG002|Outcome|Outpatient Placebo|Outpatients with diarrhea randomized to placebo oral capsule
11028916|NCT01198587|EG000|Reported Event|Outpatient Zinc Sulfate|"Outpatients with diarrhea will be randomized to zinc sulfate~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028917|NCT01198587|EG001|Reported Event|Inpatient Zinc Sulfate|"Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate~Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
11028918|NCT01198587|EG002|Reported Event|Outpatient Placebo|Outpatients with diarrhea will be randomized to placebo oral capsule
11028919|NCT01198587|EG003|Reported Event|Inpatient Placebo|Patients admitted to the hospital with diarrhea and dehydration will be randomized to placebo oral capsule
11028920|NCT01198600|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
11028921|NCT01198600|FG000|Participant Flow|Phase 1: Habitual no Replacement, Then Habitual Replacement|Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a new pair dispensed at Day 28.
11028922|NCT01198600|FG001|Participant Flow|Phase 1: Habitual Replacement, Then Habitual no Replacement|Contact lenses per participant's habitual prescription worn for 30 days with a new pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.
11028923|NCT01198600|FG002|Participant Flow|Phase 2: Lotrafilcon B Replacement|Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
11028924|NCT01198600|FG003|Participant Flow|Phase 3: Lotrafilcon B Replacement Replacement|Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28.
11028925|NCT01198600|OG000|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15 during Phase 3. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
11028926|NCT01198600|OG001|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
11028927|NCT01198600|OG000|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
11028928|NCT01198600|OG001|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.of Phase 2."
11148966|NCT01868022|OG000|Outcome|10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11028929|NCT01198600|EG000|Reported Event|Habitual Contact Lens|Contact lens per participant's habitual prescription worn for two 30-day periods in Phase 1, with a replacement dispensed at Day 28 in either Period 1 or Period 2.
11028930|NCT01198600|EG001|Reported Event|Lotrafilcon B Contact Lens|Contact lens worn for 56 days with a replacement dispensed at Day 28 in Phase 2, followed by 43 days in Phase 3 with a replacement dispensed at Day 1 and Day 14.
11028931|NCT01198691|BG000|Baseline|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
11028932|NCT01198691|BG001|Baseline|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
11028933|NCT01198691|BG002|Baseline|Total|Total of all reporting groups
11028934|NCT01198691|FG000|Participant Flow|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
11028935|NCT01198691|FG001|Participant Flow|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
11028936|NCT01198691|OG000|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
11028937|NCT01198691|OG001|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
11028938|NCT01198691|EG000|Reported Event|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
11028939|NCT01198691|EG001|Reported Event|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
11028940|NCT01198756|BG000|Baseline|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028941|NCT01198756|BG001|Baseline|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028942|NCT01198756|BG002|Baseline|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028943|NCT01198756|BG003|Baseline|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
11148967|NCT01868022|OG001|Outcome|15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11148968|NCT01868022|OG002|Outcome|20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11028944|NCT01198756|BG004|Baseline|Total|Total of all reporting groups
11028945|NCT01198756|FG000|Participant Flow|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028946|NCT01198756|FG001|Participant Flow|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028947|NCT01198756|FG002|Participant Flow|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028948|NCT01198756|FG003|Participant Flow|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
11028949|NCT01198756|OG000|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028950|NCT01198756|OG001|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028951|NCT01198756|OG002|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028952|NCT01198756|OG003|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
11028953|NCT01198756|OG000|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028954|NCT01198756|OG001|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028955|NCT01198756|OG002|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028956|NCT01198756|OG003|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028957|NCT01198756|OG004|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028958|NCT01198756|OG005|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028959|NCT01198756|OG006|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
11028960|NCT01198756|EG000|Reported Event|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028961|NCT01198756|EG001|Reported Event|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028962|NCT01198756|EG002|Reported Event|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11028963|NCT01198756|EG003|Reported Event|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
11028964|NCT01198769|BG000|Baseline|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
11028965|NCT01198769|FG000|Participant Flow|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
11028966|NCT01198769|OG000|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
11028967|NCT01198769|EG000|Reported Event|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
11028968|NCT01198795|BG000|Baseline|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
11028969|NCT01198795|FG000|Participant Flow|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
11028970|NCT01198795|OG000|Outcome|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
11028971|NCT01198795|EG000|Reported Event|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
11028972|NCT01198873|BG000|Baseline|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
11028973|NCT01198873|BG001|Baseline|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
11028974|NCT01198873|BG002|Baseline|Total|Total of all reporting groups
11028975|NCT01198873|FG000|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
11028976|NCT01198873|FG001|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
11028977|NCT01198873|OG000|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
11028978|NCT01198873|OG001|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
11028979|NCT01198873|EG000|Reported Event|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
11028980|NCT01198873|EG001|Reported Event|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
11028981|NCT01198977|BG000|Baseline|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
11028982|NCT01198977|BG001|Baseline|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
11028983|NCT01198977|BG002|Baseline|Total|Total of all reporting groups
11028984|NCT01198977|FG000|Participant Flow|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
11028985|NCT01198977|FG001|Participant Flow|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
11028986|NCT01198977|OG000|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Intervention of brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
11028987|NCT01198977|OG001|Outcome|Education Counseling|"Self-directed physical activity information and instructional video~Informational video: Mailed video of Physical activity programs"
11028988|NCT01198977|OG000|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
11028989|NCT01198977|OG001|Outcome|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
11028990|NCT01198977|EG000|Reported Event|Telephone Counseling|"Telephone based counseling and instructional video (Intervention)~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
11028991|NCT01198977|EG001|Reported Event|Education Counseling|"Exercise information and instructional video (Control)~Informational video: Mailed video of exercise programs"
11028992|NCT01199016|BG000|Baseline|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
11028993|NCT01199016|FG000|Participant Flow|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
11028994|NCT01199016|OG000|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
11028995|NCT01199016|EG000|Reported Event|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
11028996|NCT01199042|BG000|Baseline|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design)
11028997|NCT01199042|FG000|Participant Flow|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
11028998|NCT01199042|OG000|Outcome|Diagnostic Apnea-Hypopnea Index|Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured
11028999|NCT01199042|OG001|Outcome|Continuous Positive Airway Pressure Apnea-Hypopnea Index|The CPAP machine was used to determine the Apnea-Hypopnea Index.
11029000|NCT01199042|OG002|Outcome|BiPAP autoSV Apnea-Hypopnea Index|The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
11029001|NCT01199042|OG000|Outcome|BiPAP autoSV Advanced Device|Over the 90-day home treatment period, the Auto-Servo Ventilation (ASV) device consistently treated obstructive and central Sleep Disordered Breathing (SDB) events.
11029002|NCT01199042|OG000|Outcome|BiPAP autoSV Advanced Device|"Positive airway pressure device~BiPAP autoSV Advanced: The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night."
11029003|NCT01199042|OG000|Outcome|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
11029004|NCT01199042|EG000|Reported Event|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Participants had a diagnostic PSG, then CPAP and BiPAP autoSV. Participants then went home and used the autoSV for 90 days.
11029005|NCT01199055|BG000|Baseline|CS-7017 0.25 mg BID; Initial Portion|Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
11029006|NCT01199055|BG001|Baseline|CS-7017 0.50 mg BID; Initial Portion|Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
11029007|NCT01199055|BG002|Baseline|CS-7017 0.50 mg BID; Additional Portion|"Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.~Cycle 1, Day 1: Carboplatin and paclitaxel only~Cycle 1, Day 3: CS-7017 at the dose selected in initial portion~Subsequent cycles: CS-7017 with carboplatin and paclitaxel"
11029008|NCT01199055|BG003|Baseline|Total|Total of all reporting groups
11029009|NCT01199055|FG000|Participant Flow|CS-7017 0.25 mg BID; Initial Portion|Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
11029010|NCT01199055|FG001|Participant Flow|CS-7017 0.50 mg BID; Initial Portion|Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
11029011|NCT01199055|FG002|Participant Flow|CS-7017 0.50 mg BID; Additional Portion|"Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.~Cycle 1, Day 1: Carboplatin and paclitaxel only~Cycle 1, Day 3: CS-7017 at the dose selected in initial portion~Subsequent cycles: CS-7017 with carboplatin and paclitaxel"
11029012|NCT01199055|OG000|Outcome|CS-7017 0.25 mg BID; Initial Portion|Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
11029013|NCT01199055|OG001|Outcome|CS-7017 0.50 mg BID; Initial Portion|Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
11029014|NCT01199055|OG002|Outcome|CS-7017 0.50 mg BID; Additional Portion|"Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.~Cycle 1, Day 1: Carboplatin and paclitaxel only~Cycle 1, Day 3: CS-7017 at the dose selected in initial portion~Subsequent cycles: CS-7017 with carboplatin and paclitaxel"
11029015|NCT01199055|OG003|Outcome|CS71017 0.5 mg BID; Initial and Additional Portion|All participants who received 0.5 mg twice daily CS-7017 in combination with carboplatin and paclitaxel during either the initial or additional portion.
11029016|NCT01199055|OG004|Outcome|Overall|All participants who received CS-7017 in combination with carboplatin and paclitaxel.
11029017|NCT01199055|EG000|Reported Event|CS-7017 0.25 mg BID; Initial Portion|Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
11029018|NCT01199055|EG001|Reported Event|CS-7017 0.50 mg BID; Initial Portion|Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
11029019|NCT01199055|EG002|Reported Event|CS-7017 0.50 mg BID; Additional Portion|"Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.~Cycle 1, Day 1: Carboplatin and paclitaxel only~Cycle 1, Day 3: CS-7017 at the dose selected in initial portion~Subsequent cycles: CS-7017 with carboplatin and paclitaxel"
11029020|NCT01199068|BG000|Baseline|CS-7017 0.25 mg BID; Initial Portion|Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029021|NCT01199068|BG001|Baseline|CS-7017 0.50 mg BID; Initial Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029022|NCT01199068|BG002|Baseline|CS-7017 0.50 mg BID; Additional Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029023|NCT01199068|BG003|Baseline|Total|Total of all reporting groups
11029024|NCT01199068|FG000|Participant Flow|CS-7017 0.25 mg BID; Initial Portion|Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029025|NCT01199068|FG001|Participant Flow|CS-7017 0.50 mg BID; Initial Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029026|NCT01199068|FG002|Participant Flow|CS-7017 0.50 mg BID; Additional Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029027|NCT01199068|OG000|Outcome|CS-7017 0.25 mg BID; Initial Portion|Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029028|NCT01199068|OG001|Outcome|CS-7017 0.50 mg BID; Initial Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029029|NCT01199068|OG002|Outcome|CS-7017 0.50 mg BID; Additional Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029030|NCT01199068|OG003|Outcome|CS-7017 0.50 mg BID; Initial + Additional Portions|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
11029031|NCT01199068|OG004|Outcome|Overall|All participants who received CS-71017 in combination with erlotinib.
11029032|NCT01199068|OG001|Outcome|CS-7017 0.50 mg BID; Initial + Additional Portions|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
11029033|NCT01199068|OG000|Outcome|CS-7017 0.50 mg BID; Additional Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029034|NCT01199068|OG002|Outcome|Overall|All participants who received CS-71017 in combination with erlotinib.
11029035|NCT01199068|EG000|Reported Event|CS-7017 0.25 mg BID; Initial Portion|Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029036|NCT01199068|EG001|Reported Event|CS-7017 0.50 mg BID; Initial Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029037|NCT01199068|EG002|Reported Event|CS-7017 0.50 mg BID; Additional Portion|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
11029038|NCT01199068|EG003|Reported Event|CS-7017 0.50 mg BID; Initial + Additional Portions|Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
11029039|NCT01199068|EG004|Reported Event|Overall|All participants who received CS-71017 in combination with erlotinib.
11029040|NCT01199146|BG000|Baseline|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
11029041|NCT01199146|FG000|Participant Flow|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
11029042|NCT01199146|OG000|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
11029043|NCT01199146|EG000|Reported Event|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
11029044|NCT01199198|BG000|Baseline|Tolvaptan Group|Starting dose 15 mg orally once a day for 14 days.
11029045|NCT01199198|BG001|Baseline|Placebo Group|Placebo orally once a day for 14 days.
11029046|NCT01199198|BG002|Baseline|Total|Total of all reporting groups
11029047|NCT01199198|FG000|Participant Flow|Tolvaptan Group|Starting dose 15 mg orally once a day for 14 days.
11029048|NCT01199198|FG001|Participant Flow|Placebo Group|Placebo orally once a day for 14 days.
11029049|NCT01199198|OG000|Outcome|Tolvaptan Group|Starting dose 15 mg orally once a day for 14 days.
11029050|NCT01199198|OG001|Outcome|Placebo Group|Placebo orally once a day for 14 days.
11029051|NCT01199198|EG000|Reported Event|Tolvaptan Group|Starting dose 15 mg orally once a day for 14 days.
11029052|NCT01199198|EG001|Reported Event|Placebo Group|Placebo orally once a day for 14 days.
11029053|NCT01199237|BG000|Baseline|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
11029054|NCT01199237|BG001|Baseline|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
11029055|NCT01199237|BG002|Baseline|Total|Total of all reporting groups
11029056|NCT01199237|FG000|Participant Flow|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
11029057|NCT01199237|FG001|Participant Flow|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
11029058|NCT01199237|OG000|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
11029059|NCT01199237|OG001|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
11029060|NCT01199237|OG000|Outcome|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
11029061|NCT01199237|OG001|Outcome|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
11029062|NCT01199237|EG000|Reported Event|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
11029063|NCT01199237|EG001|Reported Event|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
11029064|NCT01199263|BG000|Baseline|Arm I (Paclitaxel)|Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
11029065|NCT01199263|BG001|Baseline|Arm II (Paclitaxel and Wild-type Reovirus)|"Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.~Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV"
11029066|NCT01199263|BG002|Baseline|Total|Total of all reporting groups
11029067|NCT01199263|FG000|Participant Flow|Arm I (Paclitaxel)|Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
11029068|NCT01199263|FG001|Participant Flow|Arm II (Paclitaxel and Wild-type Reovirus)|"Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.~Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV"
11029069|NCT01199263|OG000|Outcome|Arm I (Paclitaxel)|Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
11029070|NCT01199263|OG001|Outcome|Arm II (Paclitaxel and Wild-type Reovirus)|"Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.~Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV"
11029071|NCT01199263|OG000|Outcome|Arm I (Paclitaxel) Grade 3 and Above Toxicity|Grade 3 and above toxicity in patients who receive paclitaxel IV over 1 hour on days 1, 8, and 15.
11029072|NCT01199263|OG001|Outcome|Arm II (Paclitaxel and Wild-type Reovirus) Grade 3 Above|Grade 3 and above toxicity in patients who receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
11029073|NCT01199263|EG000|Reported Event|Arm I (Paclitaxel)|Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
11029074|NCT01199263|EG001|Reported Event|Arm II (Paclitaxel and Wild-type Reovirus)|"Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.~Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV"
11029075|NCT01199289|BG000|Baseline|Placebo|Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029076|NCT01199289|BG001|Baseline|AMG 827 140 mg|Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029077|NCT01199289|BG002|Baseline|AMG 827 210 mg|Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029078|NCT01199289|BG003|Baseline|AMG 827 280 mg|Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029079|NCT01199289|BG004|Baseline|Total|Total of all reporting groups
11029080|NCT01199289|FG000|Participant Flow|Placebo|Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029081|NCT01199289|FG001|Participant Flow|AMG 827 140 mg|Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029082|NCT01199289|FG002|Participant Flow|AMG 827 210 mg|Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029083|NCT01199289|FG003|Participant Flow|AMG 827 280 mg|Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029084|NCT01199289|OG000|Outcome|Placebo|Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029085|NCT01199289|OG001|Outcome|AMG 827 140 mg|Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029086|NCT01199289|OG002|Outcome|AMG 827 210 mg|Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029087|NCT01199289|OG003|Outcome|AMG 827 280 mg|Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029088|NCT01199289|OG000|Outcome|AMG 827 140 mg|Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029089|NCT01199289|OG001|Outcome|AMG 827 210 mg|Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029090|NCT01199289|OG002|Outcome|AMG 827 280 mg|Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029091|NCT01199289|EG000|Reported Event|Placebo|Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029092|NCT01199289|EG001|Reported Event|AMG 827 140 mg|Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029093|NCT01199289|EG002|Reported Event|AMG 827 210 mg|Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029094|NCT01199289|EG003|Reported Event|AMG 827 280 mg|Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
11029095|NCT01199471|BG000|Baseline|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
11029096|NCT01199471|FG000|Participant Flow|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
11029097|NCT01199471|OG000|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
11029098|NCT01199471|OG000|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
11029099|NCT01199471|EG000|Reported Event|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
11029100|NCT01199575|BG000|Baseline|Revlimid + Rituximab|"Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.~Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity."
11029101|NCT01199575|FG000|Participant Flow|Revlimid + Rituximab|"Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.~Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity."
11029102|NCT01199575|OG000|Outcome|Revlimid + Rituximab|"A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.~Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.~Revlimid~Rituximab"
11029103|NCT01199575|OG000|Outcome|Revlimid + Rituximab|"Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.~Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity."
11029104|NCT01199575|EG000|Reported Event|Revlimid + Rituximab|"Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.~Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity."
11029105|NCT01199601|BG000|Baseline|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers (control group) .~Intrapartum, postpartum counseling : Intrapartum testing and routine counseling."
11029106|NCT01199601|BG001|Baseline|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention group).~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
11029107|NCT01199601|BG002|Baseline|Total|Total of all reporting groups
11029108|NCT01199601|FG000|Participant Flow|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers of same professional cadre as intervention group.~Intrapartum, postpartum counseling : Intrapartum testing and routine counseling package provided by study."
11029109|NCT01199601|FG001|Participant Flow|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention)~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
11029110|NCT01199601|OG000|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
11029111|NCT01199601|OG001|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
11029112|NCT01199601|EG000|Reported Event|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
11029113|NCT01199601|EG001|Reported Event|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
11029114|NCT01199705|BG000|Baseline|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
11029115|NCT01199705|FG000|Participant Flow|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
11029116|NCT01199705|OG000|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
11029117|NCT01199705|OG001|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
11029118|NCT01199705|OG000|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
11029119|NCT01199705|OG001|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
11029120|NCT01199705|OG000|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
11029121|NCT01199705|OG001|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
11029122|NCT01199705|OG002|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
11029123|NCT01199705|OG000|Outcome|IVIG Treatment|Subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
11029124|NCT01199705|OG001|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
11029125|NCT01199705|OG002|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
11029126|NCT01199705|OG001|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
11029127|NCT01199705|EG000|Reported Event|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
11148969|NCT01868022|EG000|Reported Event|5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
11148970|NCT01868022|EG001|Reported Event|10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11029128|NCT01199705|EG001|Reported Event|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
11029129|NCT01199731|BG000|Baseline|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11148971|NCT01868022|EG002|Reported Event|20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A|Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
11148972|NCT01868022|EG003|Reported Event|5 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11029130|NCT01199731|BG001|Baseline|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029131|NCT01199731|BG002|Baseline|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029132|NCT01199731|BG003|Baseline|Total|Total of all reporting groups
11029133|NCT01199731|FG000|Participant Flow|GSK2248761 100 Milligram (mg)|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, Darunavir (DRV) 1 x 600 mg tablet twice daily with food orally, Ritonavir (RTV) 1 x 100 mg tablet twice daily orally and Raltegravir(RAL) 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029134|NCT01199731|FG001|Participant Flow|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029135|NCT01199731|FG002|Participant Flow|Etravirine (ETV)|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029136|NCT01199731|OG000|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029137|NCT01199731|OG001|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029138|NCT01199731|OG002|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029139|NCT01199731|EG000|Reported Event|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029140|NCT01199731|EG001|Reported Event|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029141|NCT01199731|EG002|Reported Event|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
11029142|NCT01199744|BG000|Baseline|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
11029143|NCT01199744|FG000|Participant Flow|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
11148973|NCT01868022|EG004|Reported Event|10 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11029144|NCT01199744|OG000|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
11029145|NCT01199744|EG000|Reported Event|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
11148974|NCT01868022|EG005|Reported Event|20 mg/kg GSK3052230 + Docetaxel: Arm B|Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
11148975|NCT01868022|EG006|Reported Event|10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11029146|NCT01199822|BG000|Baseline|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029147|NCT01199822|BG001|Baseline|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029148|NCT01199822|BG002|Baseline|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029149|NCT01199822|BG003|Baseline|Total|Total of all reporting groups
11029150|NCT01199822|FG000|Participant Flow|10 mg/kg Olaratumab (IMC-3G3)|10 milligrams/kilogram (mg/kg) olaratumab intravenously (IV) administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of progressive disease (PD), or until other withdrawal criteria were met.
11029151|NCT01199822|FG001|Participant Flow|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029152|NCT01199822|FG002|Participant Flow|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11148976|NCT01868022|EG007|Reported Event|15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11148977|NCT01868022|EG008|Reported Event|20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C|Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
11148978|NCT01868035|BG000|Baseline|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
11029153|NCT01199822|OG000|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029154|NCT01199822|OG001|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029155|NCT01199822|OG002|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029156|NCT01199822|OG000|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.
11029157|NCT01199822|OG001|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycle 1.
11029158|NCT01199822|OG002|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.
11029159|NCT01199822|OG000|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
11029160|NCT01199822|OG001|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
11029161|NCT01199822|OG002|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
11029162|NCT01199822|OG000|Outcome|Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029163|NCT01199822|EG000|Reported Event|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029164|NCT01199822|EG001|Reported Event|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029165|NCT01199822|EG002|Reported Event|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
11029166|NCT01199848|BG000|Baseline|All Participants|All participants received all 4 interventions (Placebo, STRB 10g, STRB 20g, and STRB 40g) in a randomized sequence Placebo: whole milk shake without strawberry powder served with the high fat/carbohydrate test meal Dose 1-10G: whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal Dose 2- 20G: whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal Dose 3-40G: whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal
11029167|NCT01199848|FG000|Participant Flow|All Study Participants|"All participants received all 4 interventions (Placebo, STRB 10g, STRB 20g, and STRB 40g) in a randomized sequence~Placebo: whole milk shake without strawberry powder served with the high fat/carbohydrate test meal Dose 1-10G: whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal Dose 2- 20G: whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal Dose 3-40G: whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal"
11148979|NCT01868035|FG000|Participant Flow|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
11029168|NCT01199848|OG000|Outcome|Placebo|"Pbo~Placebo: whole milk shake without strawberry powder served with the high fat/carbohydrate test meal"
11029169|NCT01199848|OG001|Outcome|10G STRB Powder|"Dose 1~10G: whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal"
11029170|NCT01199848|OG002|Outcome|20G STRB Powder|"Dose 2~20G: whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal"
11029171|NCT01199848|OG003|Outcome|40G STRB Powder|"Dose 3~40G: whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal"
11029172|NCT01199848|EG000|Reported Event|Placebo|"Pbo~Placebo: whole milk shake without strawberry powder served with the high fat/carbohydrate test meal"
11029173|NCT01199848|EG001|Reported Event|10G STRB Powder|"Dose 1~10G: whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal"
11029174|NCT01199848|EG002|Reported Event|20G STRB Powder|"Dose 2~20G: whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal"
11029175|NCT01199848|EG003|Reported Event|40G STRB Powder|"Dose 3~40G: whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal"
11029176|NCT01199861|BG000|Baseline|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
11029177|NCT01199861|BG001|Baseline|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
11029178|NCT01199861|BG002|Baseline|Total|Total of all reporting groups
11029179|NCT01199861|FG000|Participant Flow|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
11029180|NCT01199861|FG001|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
11029181|NCT01199861|OG000|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
11029182|NCT01199861|OG001|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
11029183|NCT01199861|EG000|Reported Event|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
11029184|NCT01199861|EG001|Reported Event|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
11029185|NCT01199926|BG000|Baseline|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
11029186|NCT01199926|BG001|Baseline|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
11029187|NCT01199926|BG002|Baseline|Total|Total of all reporting groups
11029188|NCT01199926|FG000|Participant Flow|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
11029189|NCT01199926|FG001|Participant Flow|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
11029190|NCT01199926|OG000|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
11029191|NCT01199926|OG001|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
11029192|NCT01199926|EG000|Reported Event|Vitamin D|Were asked to consume 4000 IU of vitamin D/day for 3 months while performing a resistance training intervention.
11029193|NCT01199926|EG001|Reported Event|Placebo|Were asked to consume a placebo pill (microcrystalline cellulose) each day for 3 months while performing a resistance training intervention.
11029194|NCT01199939|BG000|Baseline|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
11029195|NCT01199939|FG000|Participant Flow|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
11029196|NCT01199939|OG000|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
11029197|NCT01199939|EG000|Reported Event|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
11029198|NCT01199952|BG000|Baseline|Control|The control group will not receive a counseling phone call one month after enrollment.
11029199|NCT01199952|BG001|Baseline|Intervention|Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception.
11029200|NCT01199952|BG002|Baseline|Total|Total of all reporting groups
11029201|NCT01199952|FG000|Participant Flow|Control|The control group will not receive a counseling phone call one month after enrollment.
10887011|NCT00498433|OG000|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
11029202|NCT01199952|FG001|Participant Flow|Intervention|Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception.
11029203|NCT01199952|OG000|Outcome|Control|The control group will not receive a counseling phone call one month after enrollment.
11029204|NCT01199952|OG001|Outcome|Intervention|"Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception.~Treatment group: receives counseling phone call intervention: Subjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment."
11029205|NCT01199952|OG001|Outcome|Intervention|Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception.
11029206|NCT01199952|EG000|Reported Event|Control|The control group will not receive a counseling phone call one month after enrollment.
11029207|NCT01199952|EG001|Reported Event|Intervention|Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception.
10887012|NCT00498433|OG000|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
10887013|NCT00498433|OG001|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
10887014|NCT00498433|OG000|Outcome|Aliskiren|Part 2, Double Blind: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
11029208|NCT01199965|BG000|Baseline|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
11029209|NCT01199965|BG001|Baseline|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
11029210|NCT01199965|BG002|Baseline|Total|Total of all reporting groups
11029211|NCT01199965|FG000|Participant Flow|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
11029212|NCT01199965|FG001|Participant Flow|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
11029213|NCT01199965|OG000|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
11029214|NCT01199965|OG001|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
11029215|NCT01199965|OG002|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
11029216|NCT01199965|OG003|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
11029217|NCT01199965|OG000|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at Visit 2 or 3.
11029218|NCT01199965|OG001|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at Visit 2 or 3.
11029219|NCT01199965|OG002|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at Visit 2 or 3.
11029220|NCT01199965|OG003|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at Visit 2 or 3.
11029221|NCT01199965|EG000|Reported Event|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
11029222|NCT01199965|EG001|Reported Event|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
11029223|NCT01199965|EG002|Reported Event|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
11029224|NCT01199965|EG003|Reported Event|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
11029225|NCT01200030|BG000|Baseline|Electrical Stimulation With Exercises|electrical stimulation with exercises: electrical stimulation with exercises
11029226|NCT01200030|BG001|Baseline|Placebo Stimulation With Exercises|placebo stimulation with exercises: placebo stimulation with exercises
11029227|NCT01200030|BG002|Baseline|Control|No active treatment
11029228|NCT01200030|BG003|Baseline|Total|Total of all reporting groups
11029229|NCT01200030|FG000|Participant Flow|Electrical Stimulation With Exercises|electrical stimulation with exercises: electrical stimulation with exercises (TES+ TRlT)
11029230|NCT01200030|FG001|Participant Flow|Placebo Stimulation With Exercises|placebo stimulation with exercises: placebo stimulation with exercises (pTES+ TRlT)
11029231|NCT01200030|FG002|Participant Flow|Control|No active treatment
11029232|NCT01200030|OG000|Outcome|Electrical Stimulation With Exercises|electrical stimulation with exercises: electrical stimulation with exercises
11029233|NCT01200030|OG001|Outcome|Placebo Stimulation With Exercises|placebo stimulation with exercises: placebo stimulation with exercises
11029234|NCT01200030|OG002|Outcome|Control|No active treatment
11029235|NCT01200030|EG000|Reported Event|Electrical Stimulation With Exercises|electrical stimulation with exercises: electrical stimulation with exercises
11029236|NCT01200030|EG001|Reported Event|Placebo Stimulation With Exercises|placebo stimulation with exercises: placebo stimulation with exercises
11029237|NCT01200030|EG002|Reported Event|Control|No active treatment
11029238|NCT01200069|BG000|Baseline|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
11029239|NCT01200069|BG001|Baseline|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
11029240|NCT01200069|BG002|Baseline|Total|Total of all reporting groups
11029241|NCT01200069|FG000|Participant Flow|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
11029242|NCT01200069|FG001|Participant Flow|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
11029243|NCT01200069|OG000|Outcome|Sugar Water-one Hour After Treatment #1|500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
11029244|NCT01200069|OG001|Outcome|Ibuprofen One Hour After Treatment #1|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~subject report of myalgia one hour after completion of procedure number 1"
11029245|NCT01200069|OG002|Outcome|Sugar Water 6 Hours After Procedure #1|Subject reported myalgia 6 hours after completion of treatment # 1,
11029246|NCT01200069|OG003|Outcome|Ibuprofen 6 Hours After Treatment #1|subject reported myalgia 6 hours after treatment 1
11029247|NCT01200069|OG004|Outcome|Sugar Water 24 Hours After Treatment #1|subject reported myalgia 24 hours after completion of procedure 1
11029248|NCT01200069|OG005|Outcome|Ibuprofen 24 Hours After Treatment 1|subject reported myalgia 24 hours after procedure 1
11029249|NCT01200069|OG006|Outcome|Sugar Water 48 Hours After Procedure 1|subject reported myalgia 48 hours after procedure 1
11029250|NCT01200069|OG007|Outcome|Ibuprofen 48 Hours After Treatment 1|subject reported myalgia 48 hours after treatment day 1
11029251|NCT01200069|OG000|Outcome|Sugar Water-one Hour After Treatment 2|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
11029252|NCT01200069|OG001|Outcome|Ibuprofen One Hour After Treatment #2|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 2 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
11029253|NCT01200069|OG002|Outcome|Sugar Water 6 Hours After Procedure #2|Subject reported myalgia 6 hours after completion of treatment #2
11029254|NCT01200069|OG003|Outcome|Ibuprofen 6 Hours After Treatment #2|Subject reported myalgia 6 hours after completion of treatment #2
11029255|NCT01200069|OG004|Outcome|Sugar Water 24 Hours After Treatment #2|Subject reported myalgia 24 hours after completion of treatment #2
11029256|NCT01200069|OG005|Outcome|Ibuprofen 24 Hours After Treatment #2|Subject reported myalgia 24 hours after completion of treatment #2
11029257|NCT01200069|OG006|Outcome|Sugar Water 48 Hours After Treatment 2|Subject reported myalgia 48 hours after completion of treatment #2
11029258|NCT01200069|OG007|Outcome|Ibuprofen 48 Hours After Treatment 2|Subject reported myalgia 48 hours after completion of treatment #2
11029259|NCT01200069|OG000|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
11029260|NCT01200069|OG001|Outcome|Ibuprofen One Hour After Treatment #3|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
11029261|NCT01200069|OG002|Outcome|Sugar Water 6 Hours After Procedure #3|Subject reported myalgia 6 hours after completion of treatment #3
11029262|NCT01200069|OG003|Outcome|Ibuprofen 6 Hours After Treatment #3|Subject reported myalgia 6 hours after completion of treatment #3
11029263|NCT01200069|OG004|Outcome|Sugar Water 24 Hours After Treatment #3|Subject reported myalgia 24 hours after completion of treatment #3
11029264|NCT01200069|OG005|Outcome|Ibuprofen 24 Hours After Treatment #3|Subject reported myalgia 24 hours after completion of treatment #3
11029265|NCT01200069|OG006|Outcome|Sugar Water 48 Hours After Treatment 3|Subject reported myalgia 48 hours after completion of treatment #3
11029266|NCT01200069|OG007|Outcome|Ibuprofen 48 Hours After Treatment 3|Subject reported myalgia 48 hours after completion of treatment #3
11029267|NCT01200069|OG000|Outcome|Pain Score Sugar Water-one Hour After Treatment 1|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 1"
11029268|NCT01200069|OG001|Outcome|Pain Score Ibuprofen One Hour After Treatment #1|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
11029269|NCT01200069|OG002|Outcome|Pain Score After Sugar Water 6 Hours After Treatment #1|Subject reported headache 6 hours after completion of treatment #1
11029270|NCT01200069|OG003|Outcome|Pain Score Ibuprofen 6 Hours After Treatment #1|Subject reported headache 6 hours after completion of treatment #1
11029271|NCT01200069|OG004|Outcome|Pain Score Sugar Water 24 Hours After Treatment #1|Subject reported headache 24 hours after completion of treatment #1
11029272|NCT01200069|OG005|Outcome|Pain Score Ibuprofen 24 Hours After Treatment #1|Subjects reported headache 24 hours after completion of treatment #1
11029273|NCT01200069|OG006|Outcome|Pain Score Sugar Water 48 Hours After Treatment 1|Subjects reported headache 48 hours after completion of treatment #1
11029274|NCT01200069|OG007|Outcome|Pain Score Ibuprofen 48 Hours After Treatment 1|Subjects reported headache 48 hours after completion of treatment #1
11029275|NCT01200069|OG001|Outcome|Ibuprofen One Hour After Treatment #2|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments #2 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
11029276|NCT01200069|OG002|Outcome|Sugar Water 6 Hours After Procedure #2|Subject reported headache 6 hours after completion of treatment #2
11029277|NCT01200069|OG003|Outcome|Ibuprofen 6 Hours After Treatment #2|Subject reported headache 6 hours after completion of treatment #2
11029278|NCT01200069|OG004|Outcome|Sugar Water 24 Hours After Treatment #2|Subject reported headache 24 hours after completion of treatment #2
10887015|NCT00498433|OG001|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
11029279|NCT01200069|OG005|Outcome|Ibuprofen 24 Hours After Treatment #2|Subject reported headache 24 hours after completion of treatment #2
11029280|NCT01200069|OG006|Outcome|Sugar Water 48 Hours After Treatment #2|Subject reported headache 48 hours after completion of treatment #2
11029281|NCT01200069|OG007|Outcome|Ibuprofen 48 Hours After Treatment #2|Subject reported headache 48 hours after completion of treatment #2
11029282|NCT01200069|OG002|Outcome|Sugar Water 6 Hours After Procedure #3|Subject reported headache 6 hours after completion of treatment #3
11029283|NCT01200069|OG003|Outcome|Ibuprofen 6 Hours After Treatment #3|Subject reported headache 6 hours after completion of treatment #3
11029284|NCT01200069|OG004|Outcome|Sugar Water 24 Hours After Treatment #3|Subject reported headache 24 hours after completion of treatment #3
11029285|NCT01200069|OG005|Outcome|Ibuprofen 24 Hours After Treatment #3|Subject reported headache 24 hours after completion of treatment #3
11029286|NCT01200069|OG006|Outcome|Sugar Water 48 Hours After Treatment 3|Subject reported headache 48 hours after completion of treatment #3
11029287|NCT01200069|OG007|Outcome|Ibuprofen 48 Hours After Treatment 3|Subject reported headache 48 hours after completion of treatment #3
11029288|NCT01200069|EG000|Reported Event|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
11029289|NCT01200069|EG001|Reported Event|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
11029290|NCT01200160|BG000|Baseline|Lipid Abnormalities|
11066393|NCT01392183|FG000|Participant Flow|Temsirolimus (Control Group)|Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.
11066394|NCT01392183|FG001|Participant Flow|Pazopanib (Treatment Group)|Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.
11029291|NCT01200160|FG000|Participant Flow|Lipid Abnormalities|"No comparison groups for this observational study. Patients receive only one type of formulation, then drug exposure was the same for all patients.~This study was conducted in a prospective, single-arm, multi-center format. As this study was observational in nature, the follow-up of subject's was not prescriptive in nature and was according to the judgment of the investigator, within the period of observation set forth in the protocol.~Typically, Niaspan is titrated in the following manner: After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Ideally, Niaspan should not be increased more than 500 mg in a 4-week period and daily doses above 2000 mg are not recommended. It is expected that women may respond at lower doses than men. However, consult with the approved label for titration recommendation in the particular country."
11029292|NCT01200160|OG000|Outcome|HDL-Cholesterol|
11029293|NCT01200160|EG000|Reported Event|Lipid Abnormalities|Those with the condition and exposed to the study drug
11029294|NCT01200238|BG000|Baseline|STA-9090: Cohort A|"Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).~Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal."
11029295|NCT01200238|BG001|Baseline|STA-9090: Cohort B|"Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).~Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal."
11029296|NCT01200238|BG002|Baseline|Total|Total of all reporting groups
11029297|NCT01200238|FG000|Participant Flow|STA-9090: Cohort A|"Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).~Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal."
11029298|NCT01200238|FG001|Participant Flow|STA-9090: Cohort B|"Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).~Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal."
11029299|NCT01200238|OG000|Outcome|STA-9090: Cohort A|"Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).~Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal."
11029300|NCT01200238|OG001|Outcome|STA-9090: Cohort B|"Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).~Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal."
11029301|NCT01200238|EG000|Reported Event|STA-9090: Cohort A|"Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).~Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal."
11029302|NCT01200238|EG001|Reported Event|STA-9090: Cohort B|"Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).~Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal."
11029303|NCT01200290|BG000|Baseline|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
11029304|NCT01200290|FG000|Participant Flow|LY2127399|LY2127399 was administered as a loading dose of 240-milligram (mg) subcutaneous (SC) injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
11029305|NCT01200290|OG000|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
11029306|NCT01200290|EG000|Reported Event|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
11029307|NCT01200329|BG000|Baseline|Overall Study Group|Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)+Palifermin 60 mcg/kg IV for 3 days post SCT
11029308|NCT01200329|FG000|Participant Flow|Overall Study Group|Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)+Palifermin 60 mcg/kg IV for 3 days post SCT
11029309|NCT01200329|OG000|Outcome|Overall Study Group|Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)+Palifermin 60 mcg/kg IV for 3 days post SCT
10887016|NCT00498433|OG000|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
11029310|NCT01200329|EG000|Reported Event|Overall Study Group|Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)+Palifermin 60 mcg/kg IV for 3 days post SCT
11029311|NCT01200342|BG000|Baseline|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
11029312|NCT01200342|FG000|Participant Flow|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
11066395|NCT01392183|OG000|Outcome|Temsirolimus (Control Group)|Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.
11029313|NCT01200342|OG000|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
11029314|NCT01200342|EG000|Reported Event|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
11029315|NCT01200355|BG000|Baseline|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
11029316|NCT01200355|BG001|Baseline|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
11029317|NCT01200355|BG002|Baseline|Total|Total of all reporting groups
11029318|NCT01200355|FG000|Participant Flow|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
11029319|NCT01200355|FG001|Participant Flow|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
11029320|NCT01200355|OG000|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
11029321|NCT01200355|OG001|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
11029322|NCT01200355|EG000|Reported Event|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
11029323|NCT01200355|EG001|Reported Event|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
11029324|NCT01200368|BG000|Baseline|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
11029325|NCT01200368|BG001|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
11029326|NCT01200368|BG002|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
11029327|NCT01200368|BG003|Baseline|Total|Total of all reporting groups
11029328|NCT01200368|FG000|Participant Flow|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
10887017|NCT00498433|OG001|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
11029329|NCT01200368|FG001|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
11029330|NCT01200368|FG002|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
11029331|NCT01200368|OG000|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
11029332|NCT01200368|OG001|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
11029333|NCT01200368|OG002|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
11029334|NCT01200368|EG000|Reported Event|13vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
11029335|NCT01200368|EG001|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
11029336|NCT01200368|EG002|Reported Event|DTaP (Catch-up 7vPnC) - Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
11029337|NCT01200368|EG003|Reported Event|13vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
11029338|NCT01200368|EG004|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
11029339|NCT01200368|EG005|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
11029340|NCT01200368|EG006|Reported Event|13vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 13vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
11029341|NCT01200368|EG007|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
11029342|NCT01200368|EG008|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
11029343|NCT01200368|EG009|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
11029344|NCT01200394|BG000|Baseline|Placebo|Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
11029345|NCT01200394|BG001|Baseline|PF-00489791 20 mg|PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
11029346|NCT01200394|BG002|Baseline|Total|Total of all reporting groups
11029347|NCT01200394|FG000|Participant Flow|Placebo|Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
11029348|NCT01200394|FG001|Participant Flow|PF-00489791 20 mg|PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
11029349|NCT01200394|OG000|Outcome|Placebo|Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
11029350|NCT01200394|OG001|Outcome|PF-00489791 20 mg|PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
11029351|NCT01200394|OG000|Outcome|PF-00489791 20 mg|PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
11029352|NCT01200394|EG000|Reported Event|Placebo|Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
11029353|NCT01200394|EG001|Reported Event|PF-00489791 20 mg|PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
11029354|NCT01200407|BG000|Baseline|Normetec|Amlodipine/olmesartan medoxomil(Normetec) was prescribed and administered at the recommended starting dose of 5/20 milligrams (mg) once daily according to approved product information in the Philippines.
11029355|NCT01200407|FG000|Participant Flow|Normetec|Amlodipine/olmesartan medoxomil(Normetec) was prescribed and administered at the recommended starting dose of 5/20 milligrams (mg) once daily according to approved product information in the Philippines.
11029356|NCT01200407|OG000|Outcome|Normetec|Amlodipine/olmesartan medoxomil(Normetec) was prescribed and administered at the recommended starting dose of 5/20 milligrams (mg) once daily according to approved product information in the Philippines.
11029357|NCT01200407|EG000|Reported Event|Normetec|Amlodipine/olmesartan medoxomil(Normetec) was prescribed and administered at the recommended starting dose of 5/20 milligrams (mg) once daily according to approved product information in the Philippines.
11029358|NCT01200433|BG000|Baseline|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"
11029359|NCT01200433|BG001|Baseline|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
11029360|NCT01200433|BG002|Baseline|Total|Total of all reporting groups
11029361|NCT01200433|FG000|Participant Flow|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"
11029362|NCT01200433|FG001|Participant Flow|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
11029363|NCT01200433|OG000|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"
11029364|NCT01200433|OG001|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
11029365|NCT01200433|EG000|Reported Event|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response"
11029366|NCT01200433|EG001|Reported Event|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
11029367|NCT01200485|BG000|Baseline|Rasburicase Alone|Rasburicase by vein on Day 1 (0.15 mg/kg or a flat dose of 3 mg) as a single dose, plus as needed dosing (until day 5), during cycle 1
11029368|NCT01200485|FG000|Participant Flow|Cycle 1: Rasburicase Alone|Rasburicase by vein on Day 1 (0.15 mg/kg or a flat dose of 3 mg) as a single dose, plus as needed dosing (until day 5), during cycle 1 (21 day cycle).
11029369|NCT01200485|FG001|Participant Flow|Cycle 2, Arm A: Rasburicase|Rasburicase (0.15 mg/kg) by vein on day 1 plus as needed dosing (until day 5) during Cycle 2.
11029370|NCT01200485|FG002|Participant Flow|Cycle 2, Arm B: Allopurinol|Allopurinol (300 mg/day) each day on Days 1-5 of Cycle 2.
11029371|NCT01200485|OG000|Outcome|Arm A (Rasburicase)|Rasburicase (0.15 mg/kg) by vein on day 1 plus as needed dosing (until day 5) during Cycle 2.
11029372|NCT01200485|OG001|Outcome|Arm B (Allopurinol)|Allopurinol (300 mg/day) each day on Days 1-5 of Cycle 2.
11029373|NCT01200485|EG000|Reported Event|Cycle 1: Rasburicase Alone|Rasburicase by vein on Day 1 (0.15 mg/kg or a flat dose of 3 mg) as a single dose, plus as needed dosing (until day 5), during cycle 1 (21 day cycle).
11029374|NCT01200485|EG001|Reported Event|Cycle 2: Arm A (Rasburicase)|Rasburicase (0.15 mg/kg) by vein on day 1 plus as needed dosing (until day 5) during Cycle 2.
11029375|NCT01200485|EG002|Reported Event|Cycle 2: Arm B (Allopurinol)|Allopurinol (300 mg/day) each day on Days 1-5 of Cycle 2.
11029376|NCT01200498|BG000|Baseline|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
11029377|NCT01200498|FG000|Participant Flow|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
11029378|NCT01200498|OG000|Outcome|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
11029379|NCT01200498|EG000|Reported Event|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
11029380|NCT01200511|BG000|Baseline|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11029381|NCT01200511|FG000|Participant Flow|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11029382|NCT01200511|OG000|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11029383|NCT01200511|OG000|Outcome|ReSTOR +3.0 Toric/Without|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
11029384|NCT01200511|OG001|Outcome|ReSTOR +3.0 Toric/With|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
11029385|NCT01200511|EG000|Reported Event|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11029386|NCT01200524|BG000|Baseline|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
11029387|NCT01200524|BG001|Baseline|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
11029388|NCT01200524|BG002|Baseline|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
11029389|NCT01200524|BG003|Baseline|Total|Total of all reporting groups
11029390|NCT01200524|FG000|Participant Flow|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
11029391|NCT01200524|FG001|Participant Flow|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
11029392|NCT01200524|FG002|Participant Flow|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
10887018|NCT00498433|OG000|Outcome|Placebo run-in|Part 2, Period 1, Placebo run-in phase: After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
11029393|NCT01200524|OG000|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
11029394|NCT01200524|OG001|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
11029395|NCT01200524|OG002|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
11029396|NCT01200524|EG000|Reported Event|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
11029397|NCT01200524|EG001|Reported Event|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
11029398|NCT01200524|EG002|Reported Event|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
11029399|NCT01200589|BG000|Baseline|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
11029400|NCT01200589|BG001|Baseline|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
10887019|NCT00498433|OG001|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
10887020|NCT00498433|OG002|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
11029401|NCT01200589|BG002|Baseline|Total|Total of all reporting groups
11029402|NCT01200589|FG000|Participant Flow|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
11029403|NCT01200589|FG001|Participant Flow|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
11029404|NCT01200589|OG000|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
11029405|NCT01200589|OG001|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
11029406|NCT01200589|EG000|Reported Event|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
11029407|NCT01200589|EG001|Reported Event|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
11029408|NCT01200758|BG000|Baseline|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
11029409|NCT01200758|BG001|Baseline|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
11029410|NCT01200758|BG002|Baseline|Total|Total of all reporting groups
11029411|NCT01200758|FG000|Participant Flow|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab intravenous (IV) infusion (375 milligrams per square meter [mg/m^2]; rituximab induction) in combination with up to 8 cycles of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least partial response (PR) during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
11029412|NCT01200758|FG001|Participant Flow|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 milligrams [mg]; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
11029413|NCT01200758|FG002|Participant Flow|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
11029414|NCT01200758|FG003|Participant Flow|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
11029415|NCT01200758|OG000|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
11029416|NCT01200758|OG001|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
10887021|NCT00498433|EG000|Reported Event|Part 1: Aliskiren|All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
11029417|NCT01200758|OG000|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
11029418|NCT01200758|OG001|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
11029419|NCT01200758|OG000|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
11029420|NCT01200758|OG001|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
11029421|NCT01200758|OG001|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
11029422|NCT01200758|OG000|Outcome|All Participants|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP): Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
11029423|NCT01200758|EG000|Reported Event|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
11029424|NCT01200758|EG001|Reported Event|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
11029425|NCT01200797|BG000|Baseline|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11029426|NCT01200797|FG000|Participant Flow|Treatment (SJG-136)|SJG-136 was administered consecutively on days 1 - 3 as a 20-minute intravenous infusion, at a dose of 30 mcg/m2/day. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11029427|NCT01200797|OG000|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11029428|NCT01200797|OG000|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11029429|NCT01200797|EG000|Reported Event|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11029430|NCT01200810|BG000|Baseline|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
11029431|NCT01200810|BG001|Baseline|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
11029432|NCT01200810|BG002|Baseline|Total|Total of all reporting groups
11029433|NCT01200810|FG000|Participant Flow|Arm I - Placebo|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
11066396|NCT01392183|OG001|Outcome|Pazopanib (Treatment Group)|Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death
11029434|NCT01200810|FG001|Participant Flow|Arm II - RO4929097|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
11029435|NCT01200810|OG000|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
11029436|NCT01200810|OG001|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
11029437|NCT01200810|EG000|Reported Event|Arm I - Placebo|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
11029438|NCT01200810|EG001|Reported Event|Arm II - RO4929097|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
11029439|NCT01200875|BG000|Baseline|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
11029440|NCT01200875|FG000|Participant Flow|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
11029441|NCT01200875|OG000|Outcome|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
11029442|NCT01200875|EG000|Reported Event|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
11029443|NCT01200992|BG000|Baseline|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL~EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
11029444|NCT01200992|BG001|Baseline|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL~Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
11029445|NCT01200992|BG002|Baseline|Total|Total of all reporting groups
11029446|NCT01200992|FG000|Participant Flow|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL~EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
11029447|NCT01200992|FG001|Participant Flow|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL~Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
11029448|NCT01200992|OG000|Outcome|EN3348|"8 mg mixed with water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
11148980|NCT01868035|OG000|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
11029449|NCT01200992|OG001|Outcome|Mitomycin C|"40 mg mixed with water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
11029450|NCT01200992|OG000|Outcome|EN3348|"8 mg mixed with sterile water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
11029451|NCT01200992|OG001|Outcome|Mitomycin C|"40 mg mixed with sterile water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
11029452|NCT01200992|EG000|Reported Event|EN3348|"8 mg mixed with sterile water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
11029453|NCT01200992|EG001|Reported Event|Mitomycin C|"40 mg mixed with sterile water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
11029454|NCT01201057|BG000|Baseline|0.5% SPL7013 Gel|0.5% SPL7013 Gel: Vaginal gel
11029455|NCT01201057|BG001|Baseline|1.0% SPL7013 Gel|1.0% SPL7013 Gel: Vaginal gel
11029456|NCT01201057|BG002|Baseline|3.0% SPL7013 Gel|3.0% SPL7013 Gel: Vaginal gel
11029457|NCT01201057|BG003|Baseline|Placebo Gel|Placebo Gel: Vaginal gel
10887022|NCT00498433|EG001|Reported Event|Part 1: Amlodipine|All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.
11029458|NCT01201057|BG004|Baseline|Total|Total of all reporting groups
11029459|NCT01201057|FG000|Participant Flow|0.5% SPL7013 Gel|0.5% SPL7013 Gel: Vaginal gel
11029460|NCT01201057|FG001|Participant Flow|1.0% SPL7013 Gel|1.0% SPL7013 Gel: Vaginal gel
11029461|NCT01201057|FG002|Participant Flow|3.0% SPL7013 Gel|3.0% SPL7013 Gel: Vaginal gel
11029462|NCT01201057|FG003|Participant Flow|Placebo Gel|Placebo Gel: Vaginal gel
11029463|NCT01201057|OG000|Outcome|0.5% SPL7013 Gel|0.5% SPL7013 Gel: Vaginal gel
11029464|NCT01201057|OG001|Outcome|1.0% SPL7013 Gel|1.0% SPL7013 Gel: Vaginal gel
11029465|NCT01201057|OG002|Outcome|3.0% SPL7013 Gel|3.0% SPL7013 Gel: Vaginal gel
11029466|NCT01201057|OG003|Outcome|Placebo Gel|Placebo Gel: Vaginal gel
11029467|NCT01201057|EG000|Reported Event|0.5% SPL7013 Gel|0.5% SPL7013 Gel: Vaginal gel
11029468|NCT01201057|EG001|Reported Event|1.0% SPL7013 Gel|1.0% SPL7013 Gel: Vaginal gel
11029469|NCT01201057|EG002|Reported Event|3.0% SPL7013 Gel|3.0% SPL7013 Gel: Vaginal gel
11029470|NCT01201057|EG003|Reported Event|Placebo Gel|Placebo Gel: Vaginal gel
11029471|NCT01201265|BG000|Baseline|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
11029472|NCT01201265|FG000|Participant Flow|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
11029473|NCT01201265|OG000|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
11029474|NCT01201265|EG000|Reported Event|All Particiapants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
11029475|NCT01201317|BG000|Baseline|AZD2423 150 mg|tablets, 150 mg once daily in the morning
11029476|NCT01201317|BG001|Baseline|AZD2423 20 mg|tablets, 20 mg once daily in the morning
11029477|NCT01201317|BG002|Baseline|Placebo|tablets, once daily in the morning
11029478|NCT01201317|BG003|Baseline|Total|Total of all reporting groups
11029479|NCT01201317|FG000|Participant Flow|AZD2423 150 mg|tablets, 150 mg once daily in the morning
11029480|NCT01201317|FG001|Participant Flow|AZD2423 20 mg|tablets, 20 mg once daily in the morning
11029481|NCT01201317|FG002|Participant Flow|Placebo|tablets, once daily in the morning
11029482|NCT01201317|OG000|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
11029483|NCT01201317|OG001|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
11029484|NCT01201317|OG002|Outcome|Placebo|tablets, once daily in the morning
11029485|NCT01201317|EG000|Reported Event|AZD2423 150 mg|tablets, 150 mg once daily in the morning
11029486|NCT01201317|EG001|Reported Event|AZD2423 20 mg|tablets, 20 mg once daily in the morning
11029487|NCT01201317|EG002|Reported Event|Placebo|tablets, once daily in the morning
11029488|NCT01201343|BG000|Baseline|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
11029489|NCT01201343|FG000|Participant Flow|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
11029490|NCT01201343|OG000|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
11029491|NCT01201343|EG000|Reported Event|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
11029492|NCT01201356|BG000|Baseline|Fingolimod 0.5 mg/Day|Open-label fingolimod 0.5 mg, taken orally once daily
11029493|NCT01201356|FG000|Participant Flow|Fingolimod 0.5 mg/Day|Open-label fingolimod 0.5 mg, taken orally once daily
11029494|NCT01201356|OG000|Outcome|Fingolimod 0.5 mg/Day|Open-label fingolimod 0.5 mg, taken orally once daily
11029495|NCT01201356|EG000|Reported Event|Fingolimod 0.5 mg/Day|Open-label fingolimod 0.5 mg, taken orally once daily
11029496|NCT01201486|BG000|Baseline|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
11029497|NCT01201486|FG000|Participant Flow|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
11029498|NCT01201486|OG000|Outcome|Pregnant Women|Pregnant females in the 2nd trimester.
11029499|NCT01201486|EG000|Reported Event|Pregnant Women|Pregnant females in the 2nd trimester.
11029500|NCT01201629|BG000|Baseline|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
11029501|NCT01201629|BG001|Baseline|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
11029502|NCT01201629|BG002|Baseline|Total|Total of all reporting groups
11029503|NCT01201629|FG000|Participant Flow|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
11029504|NCT01201629|FG001|Participant Flow|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
11029505|NCT01201629|OG000|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
11029506|NCT01201629|OG001|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
11029507|NCT01201629|EG000|Reported Event|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
11029508|NCT01201629|EG001|Reported Event|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
11066397|NCT01392183|OG000|Outcome|Temsirolimus (Control Group)|Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death
11029509|NCT01201759|BG000|Baseline|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.~Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
11029510|NCT01201759|BG001|Baseline|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.~Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
11029511|NCT01201759|BG002|Baseline|Total|Total of all reporting groups
11029512|NCT01201759|FG000|Participant Flow|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.~Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
11029513|NCT01201759|FG001|Participant Flow|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.~Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
11029514|NCT01201759|OG000|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
11029515|NCT01201759|OG001|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
11029516|NCT01201759|OG000|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
11029517|NCT01201759|OG001|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
11029518|NCT01201759|EG000|Reported Event|Placebo 2gr BID|Placebo twice a day for 30 days.
11029519|NCT01201759|EG001|Reported Event|Salsalate 2gr BID|Salsalate 2grams twice a day for 30 days.
11029520|NCT01201772|BG000|Baseline|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
11029521|NCT01201772|BG001|Baseline|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
11029522|NCT01201772|BG002|Baseline|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
11029523|NCT01201772|BG003|Baseline|Total|Total of all reporting groups
11029524|NCT01201772|FG000|Participant Flow|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
11029525|NCT01201772|FG001|Participant Flow|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablet
11029526|NCT01201772|FG002|Participant Flow|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablet
11029527|NCT01201772|OG000|Outcome|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
11029528|NCT01201772|OG001|Outcome|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
11029529|NCT01201772|OG002|Outcome|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
11148981|NCT01868035|EG000|Reported Event|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
11029530|NCT01201772|EG000|Reported Event|All Study Participants|All participants who received prasugrel
11029531|NCT01201785|BG000|Baseline|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
11029532|NCT01201785|FG000|Participant Flow|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
11029533|NCT01201785|OG000|Outcome|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
11029534|NCT01201785|EG000|Reported Event|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
11148982|NCT01868074|BG000|Baseline|Customized Insole|These participants were casted for customized insoles.
11029535|NCT01201798|BG000|Baseline|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
11029536|NCT01201798|BG001|Baseline|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
11029537|NCT01201798|BG002|Baseline|Total|Total of all reporting groups
11029538|NCT01201798|FG000|Participant Flow|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
11029539|NCT01201798|FG001|Participant Flow|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
11029540|NCT01201798|OG000|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
11029541|NCT01201798|OG001|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
11029542|NCT01201798|EG000|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
11029543|NCT01201798|EG001|Reported Event|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
11029544|NCT01201811|BG000|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
11029545|NCT01201811|FG000|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
11029546|NCT01201811|OG000|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
11029547|NCT01201811|EG000|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
11029548|NCT01201850|BG000|Baseline|Bevacizumab (Avastin®)|"Once enrolled, patients were treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses.~Bevacizumab (Avastin®): bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses."
11029549|NCT01201850|FG000|Participant Flow|Bevacizumab (Avastin®)|"Once enrolled, patients were treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses.~Bevacizumab (Avastin®): bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses."
11029550|NCT01201850|OG000|Outcome|Bevacizumab (Avastin®)|"Once enrolled, patients were treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses.~Bevacizumab (Avastin®): bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses."
11029551|NCT01201850|EG000|Reported Event|Bevacizumab (Avastin®)|"Once enrolled, patients were treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses.~Bevacizumab (Avastin®): bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses."
11029552|NCT01201863|BG000|Baseline|Low T Intervention - Treatment|"Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure.~Androgel (Testosterone Gel): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g."
11029553|NCT01201863|BG001|Baseline|Low T Intervention - Placebo|"Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure.~Androgel Placebo: 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g."
11029554|NCT01201863|BG002|Baseline|Normal T No Intervention - Followed|A subset of men with TBI meeting study criteria with Normal Testosterone levels were assessed at all data collection time points. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure.
11029555|NCT01201863|BG003|Baseline|Total|Total of all reporting groups
11029556|NCT01201863|FG000|Participant Flow|Intervention - Treatment|"Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure.~Androgel (Testosterone Gel): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g."
11148983|NCT01868074|BG001|Baseline|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
10887023|NCT00498433|EG002|Reported Event|Part 2: Placebo run-in Period|After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
11029557|NCT01201863|FG001|Participant Flow|Intervention Placebo|"Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure.~Androgel Placebo: 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g."
11029558|NCT01201863|FG002|Participant Flow|Normal - No Intervention|Enrolled participants with normal T
11029559|NCT01201863|OG000|Outcome|Intervention - Treatment|"Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to either a treatment or placebo group. They participated in blood assays at baseline and every other week for up to 12 weeks during inpatient rehabilitation hospitalization. At the same assessment points, they were also scored on the FIM (primary outcome measure) and were administered the NIH Toolbox (Secondary Outcome Measure).~Androgel (Testosterone Gel): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g."
11148984|NCT01868074|BG002|Baseline|Total|Total of all reporting groups
11029560|NCT01201863|OG001|Outcome|Intervention Placebo|"Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to either a treatment or placebo group. They participated in blood assays at baseline and every other week for up to 12 weeks during inpatient rehabilitation hospitalization. At the same assessment points, they were also scored on the FIM (primary outcome measure) and were administered the NIH Toolbox (Secondary Outcome Measure).~Androgel Placebo: 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g."
11029561|NCT01201863|OG002|Outcome|No Intervention|Men with TBI and normal T were followed for assessments only. They participated in blood assays at baseline and every other week for up to 12 weeks during inpatient rehabilitation hospitalization. At the same assessment points, they were also scored on the FIM (primary outcome measure) and were administered the NIH Toolbox (Secondary Outcome Measure).
11029562|NCT01201863|EG000|Reported Event|Low T Intervention - Treatment|"Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure).~Androgel (Testosterone Gel): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g."
11029563|NCT01201863|EG001|Reported Event|Low T Intervention - Placebo|"Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure).~Androgel Placebo: 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g."
11029564|NCT01201863|EG002|Reported Event|Normal T - No Intervention|A subset of men with TBI meeting study criteria with Normal Testosterone levels will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure).
11029565|NCT01201915|BG000|Baseline|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
11029566|NCT01201915|BG001|Baseline|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
11029567|NCT01201915|BG002|Baseline|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
11029568|NCT01201915|BG003|Baseline|Total|Total of all reporting groups
11029569|NCT01201915|FG000|Participant Flow|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
11029570|NCT01201915|FG001|Participant Flow|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
11029571|NCT01201915|FG002|Participant Flow|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
11029572|NCT01201915|OG000|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
11029573|NCT01201915|OG001|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
11029574|NCT01201915|OG002|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
11029575|NCT01201915|EG000|Reported Event|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
11029576|NCT01201915|EG001|Reported Event|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
11029577|NCT01201915|EG002|Reported Event|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
10887024|NCT00498433|EG003|Reported Event|Part 2: Aliskiren|Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
11029578|NCT01201967|BG000|Baseline|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
11029579|NCT01201967|BG001|Baseline|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
11029580|NCT01201967|BG002|Baseline|Total|Total of all reporting groups
11029581|NCT01201967|FG000|Participant Flow|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
11029582|NCT01201967|FG001|Participant Flow|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
11029583|NCT01201967|OG000|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
11029584|NCT01201967|OG001|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
11029585|NCT01201967|OG001|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
11029586|NCT01201967|EG000|Reported Event|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
11029587|NCT01201967|EG001|Reported Event|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
11029588|NCT01202071|BG000|Baseline|Entire Study Population: Group A, Group B, Group C, Group D|"Includes Group A, Group B, Group C, and Group D. Participants received Rabeprazole sodium Tablets for 5 days in each period.~Group A Period I: 5 mg, Period II: 10 mg, Period III: 20 mg, Period IV: 40 mg~Group B Period I: 10 mg, Period II: 20 mg, Period III: 40 mg, Period IV: 5 mg~Group C Period I: 20 mg, Period II: 40 mg, Period III: 5 mg, Period IV: 10 mg~Group D Period I: 40 mg, Period II: 5 mg, Period III: 10 mg, Period IV: 20 mg~Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV, a washout period consisted of 6 days or longer between each period."
11029589|NCT01202071|FG000|Participant Flow|Group A: Rapeprazole 5 mg, Then 10 mg, Then 20 mg, Then 40 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 5 mg; Period II (8 days total): 10 mg; Period III (8 days total): 20 mg; Period IV (8 days total): 40 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
11029590|NCT01202071|FG001|Participant Flow|Group B: Rapeprazole 10 mg, Then 20 mg, Then 40 mg, Then 5 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 10 mg; Period II (8 days total): 20 mg; Period III (8 days total): 40 mg; Period IV (8 days total): 5 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
11029591|NCT01202071|FG002|Participant Flow|Group C: Rapeprazole 20 mg, Then 40 mg, Then 5 mg, Then 10 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 20 mg; Period II (8 days total): 40 mg; Period III (8 days total): 5 mg; Period IV (8 days total): 10 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
11029592|NCT01202071|FG003|Participant Flow|Group D: Rapeprazole 40 mg, Then 5 mg, Then 10 mg, Then 20 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 40 mg; Period II (8 days total): 5 mg; Period III (8 days total): 10 mg; Period IV (8 days total): 20 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
11029593|NCT01202071|OG000|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
11029594|NCT01202071|OG001|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
11029595|NCT01202071|OG002|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
11029596|NCT01202071|OG003|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
11029597|NCT01202071|EG000|Reported Event|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
11029598|NCT01202071|EG001|Reported Event|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
11029599|NCT01202071|EG002|Reported Event|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
11029600|NCT01202071|EG003|Reported Event|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
11029601|NCT01202162|BG000|Baseline|Desflurane|Administration of Desflurane
11029602|NCT01202162|BG001|Baseline|Sevoflurane|Administration of Sevoflurane
11029603|NCT01202162|BG002|Baseline|Total|Total of all reporting groups
11029604|NCT01202162|FG000|Participant Flow|Desflurane|Administration of Desflurane
11029605|NCT01202162|FG001|Participant Flow|Sevoflurane|Administration of Sevoflurane
11029606|NCT01202162|OG000|Outcome|Desflurane|Administration of Desflurane
11029607|NCT01202162|OG001|Outcome|Sevoflurane|Administration of Sevoflurane
11029608|NCT01202162|EG000|Reported Event|Desflurane|Administration of Desflurane
11029609|NCT01202162|EG001|Reported Event|Sevoflurane|Administration of Sevoflurane
11029610|NCT01202175|BG000|Baseline|Nebivolol|Nebivolol: Oral nebivolol 5 mg once daily
11029611|NCT01202175|BG001|Baseline|Placebo|
11029612|NCT01202175|BG002|Baseline|Total|Total of all reporting groups
11029613|NCT01202175|FG000|Participant Flow|All Study Participants|Oral nebivolol 5 mg once daily or Placebo (sugar pill) once dailly. Arms/Groups are combined in this module because the only access to data is a publication that was published before Principal Invesitgator passed away. According to the publication; two participants dropped out because of flu-like symptoms, 2 were lost to follow-up, and 1 dropped out of the study after the initial visit but never took the medication. It is unknown what arm they were in.
11029614|NCT01202175|OG000|Outcome|Nebivolol|Nebivolol: Oral nebivolol 5 mg once daily
11029615|NCT01202175|OG001|Outcome|Placebo|
11029616|NCT01202175|EG000|Reported Event|All Study Particpants|Oral nebivolol 5 mg once daily or Placebo (sugar pill) once dailly. Arms/Groups are combined in this module because the only access to data is a publication that was published before Principal Invesitgator passed away. According to the publication; two participants dropped out because of flu-like symptoms, 2 were lost to follow-up, and 1 dropped out of the study after the initial visit but never took the medication. It is unknown what arm they were in.
11029617|NCT01202188|BG000|Baseline|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029618|NCT01202188|BG001|Baseline|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029619|NCT01202188|BG002|Baseline|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029620|NCT01202188|BG003|Baseline|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029621|NCT01202188|BG004|Baseline|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029622|NCT01202188|BG005|Baseline|Total|Total of all reporting groups
11029623|NCT01202188|FG000|Participant Flow|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029624|NCT01202188|FG001|Participant Flow|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029625|NCT01202188|FG002|Participant Flow|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
10887025|NCT00498433|EG004|Reported Event|Part 2: Amlodipine|Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
11029626|NCT01202188|FG003|Participant Flow|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029627|NCT01202188|FG004|Participant Flow|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029628|NCT01202188|OG000|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
11029629|NCT01202188|OG001|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
11029630|NCT01202188|OG002|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
11029631|NCT01202188|OG001|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
11029632|NCT01202188|OG003|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
11029633|NCT01202188|OG001|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via the manufacturer's proprietary device for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
11029634|NCT01202188|OG000|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029635|NCT01202188|OG001|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029636|NCT01202188|OG002|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029637|NCT01202188|OG003|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029638|NCT01202188|OG004|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029639|NCT01202188|EG000|Reported Event|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029640|NCT01202188|EG001|Reported Event|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029641|NCT01202188|EG002|Reported Event|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029642|NCT01202188|EG003|Reported Event|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029643|NCT01202188|EG004|Reported Event|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
11029644|NCT01202227|BG000|Baseline|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
11029645|NCT01202227|FG000|Participant Flow|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
11029646|NCT01202227|OG000|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
11029647|NCT01202227|EG000|Reported Event|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
11029648|NCT01202253|BG000|Baseline|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
11029649|NCT01202253|FG000|Participant Flow|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
11029650|NCT01202253|OG000|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
11029651|NCT01202253|EG000|Reported Event|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
11029652|NCT01202279|BG000|Baseline|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
11029653|NCT01202279|BG001|Baseline|Placebo|Placebo given bid with a full glass of water for 7 days
11029654|NCT01202279|BG002|Baseline|Total|Total of all reporting groups
11029655|NCT01202279|FG000|Participant Flow|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
11029656|NCT01202279|FG001|Participant Flow|Placebo|Placebo given bid with a full glass of water for 7 days
11029657|NCT01202279|OG000|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
11029658|NCT01202279|OG001|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
11029659|NCT01202279|EG000|Reported Event|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
11029660|NCT01202279|EG001|Reported Event|Placebo|Placebo given bid with a full glass of water for 7 days
11029661|NCT01202409|BG000|Baseline|Capecitabine + Panitumumab + Oxaliplatin|Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11029662|NCT01202409|FG000|Participant Flow|Capecitabine + Panitumumab + Oxaliplatin|Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11029663|NCT01202409|OG000|Outcome|Capecitabine + Panitumumab + Oxaliplatin|Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11029664|NCT01202409|EG000|Reported Event|Capecitabine + Panitumumab + Oxaliplatin|Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11029665|NCT01202565|BG000|Baseline|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
11029666|NCT01202565|FG000|Participant Flow|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
11029667|NCT01202565|OG000|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
11029668|NCT01202565|EG000|Reported Event|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
11029669|NCT01202578|BG000|Baseline|Tympanostomy Tube Placement Using the Tube Delivery System|
11029670|NCT01202578|FG000|Participant Flow|Tympanostomy Tube Placement Using the Tube Delivery System|
11029671|NCT01202578|OG000|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
11029672|NCT01202578|EG000|Reported Event|Safety Events|Safety in terms of number affected subjects in total number of subjects.
11029673|NCT01202591|BG000|Baseline|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
11029674|NCT01202591|BG001|Baseline|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
11029675|NCT01202591|BG002|Baseline|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
11029676|NCT01202591|BG003|Baseline|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
11225839|NCT02370537|BG001|Baseline|Intermediate FEC (EPANOVA® and OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
11029677|NCT01202591|BG004|Baseline|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
11029678|NCT01202591|BG005|Baseline|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
11029679|NCT01202591|BG006|Baseline|Total|Total of all reporting groups
11029680|NCT01202591|FG000|Participant Flow|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
11029681|NCT01202591|FG001|Participant Flow|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
11029682|NCT01202591|FG002|Participant Flow|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
11029683|NCT01202591|FG003|Participant Flow|AZD4547 80mg bd 2w/1w + Ex|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
11029684|NCT01202591|FG004|Participant Flow|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
11029685|NCT01202591|FG005|Participant Flow|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
11029686|NCT01202591|OG000|Outcome|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
11029687|NCT01202591|OG001|Outcome|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
11029688|NCT01202591|OG002|Outcome|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
11029689|NCT01202591|OG003|Outcome|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
11029690|NCT01202591|OG004|Outcome|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
11029691|NCT01202591|OG005|Outcome|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
11029692|NCT01202591|EG000|Reported Event|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
11029693|NCT01202591|EG001|Reported Event|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
11029694|NCT01202591|EG002|Reported Event|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
11029695|NCT01202591|EG003|Reported Event|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
11029696|NCT01202591|EG004|Reported Event|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
11029697|NCT01202591|EG005|Reported Event|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
11029698|NCT01202643|BG000|Baseline|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
11029699|NCT01202643|BG001|Baseline|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
11029700|NCT01202643|BG002|Baseline|Total|Total of all reporting groups
11029701|NCT01202643|FG000|Participant Flow|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
11029702|NCT01202643|FG001|Participant Flow|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
11029703|NCT01202643|OG000|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
11029704|NCT01202643|OG001|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
11029705|NCT01202643|EG000|Reported Event|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
11029706|NCT01202643|EG001|Reported Event|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
11029707|NCT01202656|BG000|Baseline|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation~then~Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
11029708|NCT01202656|BG001|Baseline|Saline Then G-CSF|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation~then~G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
11029709|NCT01202656|BG002|Baseline|Total|Total of all reporting groups
11029710|NCT01202656|FG000|Participant Flow|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of human chorionic gonadotropin(hCG) trigger for Ovulation"
11029711|NCT01202656|FG001|Participant Flow|Saline Then G-CSF|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
11029712|NCT01202656|OG000|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
11029713|NCT01202656|OG001|Outcome|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
11029714|NCT01202656|EG000|Reported Event|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
11029715|NCT01202656|EG001|Reported Event|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
11029716|NCT01202721|BG000|Baseline|Atenolol|Atenolol 25 mg up-titrated to 100 mg.
11029717|NCT01202721|BG001|Baseline|Telmisartan|Telmisartan 40 mg up-titrated to 80mg
11029718|NCT01202721|BG002|Baseline|Atenolol Placebo|Participants randomized to receive Atenolol placebo
11029719|NCT01202721|BG003|Baseline|Telmisartan Placebo|Participants randomized to receive Telmisartan placebo
11029720|NCT01202721|BG004|Baseline|Total|Total of all reporting groups
11029721|NCT01202721|FG000|Participant Flow|Atenolol|Atenolol 25 mg up-titrated to 100 mg.
11029722|NCT01202721|FG001|Participant Flow|Telmisartan|Telmisartan 40 mg up-titrated to 80mg
11029723|NCT01202721|FG002|Participant Flow|Atenolol Placebo|Participants in Atenolol group, randomized to receive matching placebo
11029724|NCT01202721|FG003|Participant Flow|Telmisartan Placebo|Participants in Telmisartan group, randomized to receive matching placebo
11029725|NCT01202721|OG000|Outcome|Atenolol|Atenolol 25 mg up-titrated to 100 mg.
11029726|NCT01202721|OG001|Outcome|Telmisartan|Telmisartan 40 mg up-titrated to 80mg
11029727|NCT01202721|OG002|Outcome|Atenolol Placebo|Participants randomized to receive atenolol placebo
11029728|NCT01202721|OG003|Outcome|Telmisartan Placebo|Participants randomized to receive telmisartan placebo
11029729|NCT01202721|OG002|Outcome|Atenolol Placebo|Participants randomized to receive Atenolol placebo
11029730|NCT01202721|OG003|Outcome|Telmisartan Placebo|Participants randomized to receive Telmisartan placebo
11029731|NCT01202721|EG000|Reported Event|Atenolol|Atenolol 25 mg up-titrated to 100 mg.
11029732|NCT01202721|EG001|Reported Event|Telmisartan|Telmisartan 40 mg up-titrated to 80mg
11029733|NCT01202721|EG002|Reported Event|Atenolol Placebo|Participants randomized to receive atenolol placebo
11029734|NCT01202721|EG003|Reported Event|Telmisartan Placebo|Participants randomized to receive telmisartan placebo
11029735|NCT01202747|BG000|Baseline|LipiFlow Treatment|Treatment with LipiFlow device
11029736|NCT01202747|FG000|Participant Flow|LipiFlow Treatment|Treatment with LipiFlow device
11029737|NCT01202747|OG000|Outcome|LipiFlow Treatment|Treatment with LipiFlow device
11029738|NCT01202747|EG000|Reported Event|LipiFlow Treatment|Treatment with LipiFlow device
11029739|NCT01202760|BG000|Baseline|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.~After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
11029740|NCT01202760|BG001|Baseline|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
11029741|NCT01202760|BG002|Baseline|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
11029742|NCT01202760|BG003|Baseline|Total|Total of all reporting groups
11066398|NCT01392183|OG001|Outcome|Pazopanib (Treatment Group)|Pazopanib 800 mg orally daily. Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death
11029743|NCT01202760|FG000|Participant Flow|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.~After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
11029744|NCT01202760|FG001|Participant Flow|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
11029745|NCT01202760|FG002|Participant Flow|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
11029746|NCT01202760|OG000|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
11029747|NCT01202760|OG001|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
11029748|NCT01202760|OG002|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
11029749|NCT01202760|OG000|Outcome|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
11029750|NCT01202760|OG001|Outcome|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
11029751|NCT01202760|OG002|Outcome|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
11029752|NCT01202760|OG000|Outcome|LY2127399|"120 milligrams (mg) LY2127399: subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~90 milligrams (mg) LY2127399: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
11029753|NCT01202760|EG000|Reported Event|120 mg LY2127399, Randomized Treatment Period|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.~The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders."
11029754|NCT01202760|EG001|Reported Event|90 mg LY2127399, Randomized Treatment Period|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders."
11029755|NCT01202760|EG002|Reported Event|Placebo, Randomized Treatment Period|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders."
11029756|NCT01202760|EG003|Reported Event|120 mg LY2127399, Rescue Period|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders."
11029757|NCT01202760|EG004|Reported Event|90 mg LY2127399, Rescue Period|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders."
11029758|NCT01202760|EG005|Reported Event|Placebo, Rescue Period|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders."
11029759|NCT01202760|EG006|Reported Event|120 mg LY2127399, Follow-up Period|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029760|NCT01202760|EG007|Reported Event|90 mg LY2127399, Follow-up Period|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029761|NCT01202760|EG008|Reported Event|Placebo, Follow-up Period|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029762|NCT01202760|EG009|Reported Event|120 mg LY2127399 to 90 mg LY212739 (Week 16), Follow-up Period|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029763|NCT01202760|EG010|Reported Event|Placebo to 90 mg LY2127399 (Week 16), Follow-up Period|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029764|NCT01202773|BG000|Baseline|120 mg LY2127399|"A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
11029765|NCT01202773|BG001|Baseline|90 mg LY2127399|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.~At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
11029766|NCT01202773|BG002|Baseline|Placebo|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
11029767|NCT01202773|BG003|Baseline|Total|Total of all reporting groups
11029768|NCT01202773|FG000|Participant Flow|120 mg LY2127399|"A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W) for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W).~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
11029769|NCT01202773|FG001|Participant Flow|90 mg LY2127399|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.~At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
11029770|NCT01202773|FG002|Participant Flow|Placebo|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
11029771|NCT01202773|OG000|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
11029772|NCT01202773|OG001|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
11029773|NCT01202773|OG002|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
11029774|NCT01202773|OG001|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period
11066399|NCT01392183|EG000|Reported Event|Temsirolimus (Control Group)|Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.
11066400|NCT01392183|EG001|Reported Event|Pazopanib (Treatment Group)|Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.
11029775|NCT01202773|OG000|Outcome|120 mg LY2127399|"A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks or a loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period or 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
11029776|NCT01202773|EG000|Reported Event|LY 120 mg Q4W, Randomized Treatment Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
11029777|NCT01202773|EG001|Reported Event|LY 90 mg Q2W, Randomized Treatment Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
11029778|NCT01202773|EG002|Reported Event|Placebo, Randomized Treatment Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.~The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
11029779|NCT01202773|EG003|Reported Event|LY 120 mg Q4W, Rescue Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR."
11029780|NCT01202773|EG004|Reported Event|LY 90 mg Q2W, Rescue Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 16 weeks.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR."
11029781|NCT01202773|EG005|Reported Event|Placebo, Rescue Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR."
11029782|NCT01202773|EG006|Reported Event|LY 120 mg Q4W, Follow-up Period|"A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029783|NCT01202773|EG007|Reported Event|LY 90 mg Q2W, Follow-up Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029784|NCT01202773|EG008|Reported Event|Placebo, Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029785|NCT01202773|EG009|Reported Event|LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029786|NCT01202773|EG010|Reported Event|Placebo to LY 90 mg Q2W (Week 16), Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
11029787|NCT01202877|BG000|Baseline|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine (AZA) 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
11029788|NCT01202877|BG001|Baseline|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
11029789|NCT01202877|BG002|Baseline|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
11029790|NCT01202877|BG003|Baseline|Total|Total of all reporting groups
11029791|NCT01202877|FG000|Participant Flow|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
11029792|NCT01202877|FG001|Participant Flow|Phase I: 5-azacytidine + PKC412 50 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
11029793|NCT01202877|FG002|Participant Flow|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
11029794|NCT01202877|OG000|Outcome|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
11029795|NCT01202877|OG001|Outcome|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
11029796|NCT01202877|OG002|Outcome|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
11029797|NCT01202877|EG000|Reported Event|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
11029798|NCT01202877|EG001|Reported Event|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
11029799|NCT01202877|EG002|Reported Event|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
11029800|NCT01202903|BG000|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
11029801|NCT01202903|BG001|Baseline|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
11029802|NCT01202903|BG002|Baseline|Total|Total of all reporting groups
11029803|NCT01202903|FG000|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
11029804|NCT01202903|FG001|Participant Flow|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
11029805|NCT01202903|OG000|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
11029806|NCT01202903|OG001|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
11029807|NCT01202903|EG000|Reported Event|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
11029808|NCT01202903|EG001|Reported Event|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
11029809|NCT01202955|BG000|Baseline|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
11029810|NCT01202955|BG001|Baseline|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
11029811|NCT01202955|BG002|Baseline|Total|Total of all reporting groups
11029812|NCT01202955|FG000|Participant Flow|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
11029813|NCT01202955|FG001|Participant Flow|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
11029814|NCT01202955|OG000|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
11029815|NCT01202955|OG001|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
11029816|NCT01202955|EG000|Reported Event|Tolcapone First, Then Placebo|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:~Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally~During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
11029817|NCT01202955|EG001|Reported Event|Placebo First, Then Tolcapone|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:~Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally~During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
11029818|NCT01202994|BG000|Baseline|Flute and pe|Participants receive a flutemetamol PET scan and two cognitive testing sessions across one week
11029819|NCT01202994|FG000|Participant Flow|Flute and pe|Participants receive a flutemetamol PET scan and two cognitive testing sessions across one week
11029820|NCT01202994|OG000|Outcome|Flute|"Flutemetamol PET scan.~18F-Flutemetamol: All subjects will undergo a PET scan with 18F-PIB. Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject."
11029821|NCT01202994|OG000|Outcome|Flute|"Flutemetamol PET scan.~18F-Flutemetamol: All subjects will undergo a PET scan with 18F-PIB, within six months of also undergoing an FDG-PET scan (PET scans will occur on separate days).~For the 18F-PIB PET scan: Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject.~The FDG-PET scan will follow the same procedures as routine scans obtained in a clinical setting (approximately 370 MBq of 18F-FDG will be injected intravenously and PET data collected for each subject). FDG-PET data will be used to correlate metabolic changes and for anatomic co-registration of 18F-PIB images."
11029822|NCT01202994|EG000|Reported Event|Flute and pe|Participants receive a flutemetamol PET scan and two cognitive testing sessions across one week
11066401|NCT01392300|BG000|Baseline|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
11066402|NCT01392300|BG001|Baseline|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
11066403|NCT01392300|BG002|Baseline|Total|Total of all reporting groups
11066404|NCT01392300|FG000|Participant Flow|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
11066405|NCT01392300|FG001|Participant Flow|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
11066406|NCT01392300|FG002|Participant Flow|OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
11066407|NCT01392300|OG000|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
11066408|NCT01392300|OG001|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
11066409|NCT01392300|EG000|Reported Event|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
11066410|NCT01392300|EG001|Reported Event|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
11066411|NCT01392300|EG002|Reported Event|OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
11066412|NCT01392326|BG000|Baseline|Group 1|Secukinumab (75mg)
11066413|NCT01392326|BG001|Baseline|Group 2|Secukinumab (150 mg)
11066414|NCT01392326|BG002|Baseline|Group 3|Placebo match (for 75 and 150 mg)
11066415|NCT01392326|BG003|Baseline|Total|Total of all reporting groups
11066416|NCT01392326|FG000|Participant Flow|AIN457 (75 mg)|Secukinumab (75mg)
11066417|NCT01392326|FG001|Participant Flow|AIN457 (150 mg)|Secukinumab (150 mg)
11066418|NCT01392326|FG002|Participant Flow|Placebo Match for AIN457 ( 75 and 150 mg)|Placebo match (for 75 and 150 mg)
11066419|NCT01392326|OG000|Outcome|Group 1|Secukinumab (75mg)
11066420|NCT01392326|OG001|Outcome|Group 2|Secukinumab (150 mg)
11066421|NCT01392326|OG002|Outcome|Group 3|Placebo match (for 75 and 150 mg)
11066422|NCT01392326|EG000|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
11066423|NCT01392326|EG001|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
11066424|NCT01392326|EG002|Reported Event|Placebo|Placebo. After week 24, only reponders continued to receive placebo to the end of the trial.
11150224|NCT01876446|FG000|Participant Flow|A: Chemo Resistant|"Group A: chemo resistant - those progressing on first-line therapy < 3 months after completion of treatment.~Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies"
11029823|NCT01203046|BG000|Baseline|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
11029824|NCT01203046|BG001|Baseline|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
11029825|NCT01203046|BG002|Baseline|Total|Total of all reporting groups
11029826|NCT01203046|FG000|Participant Flow|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
11029827|NCT01203046|FG001|Participant Flow|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
11029828|NCT01203046|OG000|Outcome|GROUP A: 7 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
11029829|NCT01203046|OG001|Outcome|GROUP B - 3 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
11029830|NCT01203046|OG000|Outcome|GROUP A - 7 DAYS THERAPY|Patients with 7 days therapy
11029831|NCT01203046|OG001|Outcome|GROUP B - 3 DAYS THERAPY|Patients with 3 days therapy
11029832|NCT01203046|EG000|Reported Event|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
11029833|NCT01203046|EG001|Reported Event|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
11029834|NCT01203072|BG000|Baseline|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
11029835|NCT01203072|BG001|Baseline|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
11029836|NCT01203072|BG002|Baseline|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
11029837|NCT01203072|BG003|Baseline|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
11029838|NCT01203072|BG004|Baseline|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
11029839|NCT01203072|BG005|Baseline|Total|Total of all reporting groups
11029840|NCT01203072|FG000|Participant Flow|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
11029841|NCT01203072|FG001|Participant Flow|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
11029842|NCT01203072|FG002|Participant Flow|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
11029843|NCT01203072|FG003|Participant Flow|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
11029844|NCT01203072|FG004|Participant Flow|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
11029845|NCT01203072|OG000|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
11029846|NCT01203072|OG001|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
11029847|NCT01203072|OG002|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
11029848|NCT01203072|OG003|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
11029849|NCT01203072|OG004|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
11029850|NCT01203072|EG000|Reported Event|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
11029851|NCT01203072|EG001|Reported Event|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
11029852|NCT01203072|EG002|Reported Event|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
11029853|NCT01203072|EG003|Reported Event|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
11029854|NCT01203072|EG004|Reported Event|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
11029855|NCT01203098|BG000|Baseline|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
11029856|NCT01203098|BG001|Baseline|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
11029857|NCT01203098|BG002|Baseline|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
11029858|NCT01203098|BG003|Baseline|Total|Total of all reporting groups
11029859|NCT01203098|FG000|Participant Flow|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
11029860|NCT01203098|FG001|Participant Flow|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
11029861|NCT01203098|FG002|Participant Flow|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
11029862|NCT01203098|OG000|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
11029863|NCT01203098|OG001|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
11029864|NCT01203098|OG002|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
11029865|NCT01203098|EG000|Reported Event|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
11029866|NCT01203098|EG001|Reported Event|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
11029867|NCT01203098|EG002|Reported Event|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
11029868|NCT01203189|BG000|Baseline|Shampoo Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
11029869|NCT01203189|BG001|Baseline|Foam Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
11029870|NCT01203189|BG002|Baseline|Cross Over Group|"Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
11029871|NCT01203189|BG003|Baseline|Total|Total of all reporting groups
11029872|NCT01203189|FG000|Participant Flow|Shampoo Only Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
11029873|NCT01203189|FG001|Participant Flow|Foam Only Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
11029874|NCT01203189|FG002|Participant Flow|Shampoo First and Then Foam|subjects used shampoo for 4 weeks, but did not reach 60% improvement on TDSS score were given foam treatment for 4 weeks
11029875|NCT01203189|OG000|Outcome|Shampoo Only Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
11029876|NCT01203189|OG001|Outcome|Foam Only Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
11029877|NCT01203189|OG002|Outcome|Cross Over Group|"Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
11029878|NCT01203189|EG000|Reported Event|Shampoo Only Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
11029879|NCT01203189|EG001|Reported Event|Foam Only Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
11029880|NCT01203189|EG002|Reported Event|Cross Over Group|"Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
11029881|NCT01203319|BG000|Baseline|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029882|NCT01203319|BG001|Baseline|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029883|NCT01203319|BG002|Baseline|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029884|NCT01203319|BG003|Baseline|Total|Total of all reporting groups
11029885|NCT01203319|FG000|Participant Flow|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029886|NCT01203319|FG001|Participant Flow|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029887|NCT01203319|FG002|Participant Flow|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029888|NCT01203319|OG000|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029889|NCT01203319|OG001|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029890|NCT01203319|OG002|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029891|NCT01203319|EG000|Reported Event|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029892|NCT01203319|EG001|Reported Event|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029893|NCT01203319|EG002|Reported Event|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
11029894|NCT01203644|BG000|Baseline|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11029895|NCT01203644|BG001|Baseline|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
11029896|NCT01203644|BG002|Baseline|Total|Total of all reporting groups
11029897|NCT01203644|FG000|Participant Flow|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11029898|NCT01203644|FG001|Participant Flow|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
11029899|NCT01203644|OG000|Outcome|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. Single 100 mg administration of 0.25% solution (i.e., 0.5% diluted 1:1) in a 40-mL volume via local infiltration
11029900|NCT01203644|OG001|Outcome|SKY0402 Low Dose|Single administration of SKY0402 (low dose, 175 mg) in a 40-mL volume via local infiltration
11029901|NCT01203644|OG002|Outcome|SKY0402 Low-mid Dose|Single administration of SKY0402 (low-mid dose, 225 mg) in a 40-mL volume via local infiltration
11029902|NCT01203644|OG003|Outcome|SKY0402 High-mid Dose|Single administration of SKY0402 (high-mid dose, 300 mg) in a 40-mL volume via local infiltration
11029903|NCT01203644|OG004|Outcome|SKY0402 High Dose|Single administration of SKY0402 (high dose, 350 mg) in a 40-mL volume via local infiltration
11029904|NCT01203644|EG000|Reported Event|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11029905|NCT01203644|EG001|Reported Event|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
11029906|NCT01203774|BG000|Baseline|All Participants|"Pen-administered, then syringe-admnistered Glargine Group (1) AND Syringe-administered then pen-administered Glargine Group (2)~Group 1: SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin Glargine insulin: 20-180 units per day~Group 2: Syringe-administered Glargine insulin and then pen-administered Glargine insulin Glargine insulin: 20-180 units per day"
11029907|NCT01203774|FG000|Participant Flow|Pen-administered, Then Syringe-admnistered Glargine|"SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin~Glargine insulin: 20-180 units per day"
11029908|NCT01203774|FG001|Participant Flow|Syringe-administered Then Pen-administered Glargine|"Syringe-administered Glargine insulin and then pen-administered Glargine insulin~Glargine insulin: 20-180 units per day"
11029909|NCT01203774|OG000|Outcome|Group 1: Pen-administered, Then Syringe-admnistered Glargine|"SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin~Glargine insulin: 20-180 units per day"
11150225|NCT01876446|FG001|Participant Flow|B: Chemo Sensitive|"Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.~Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Pegylated Irinotecan: Given IV~Pharmacological Study: Correlative studies"
11225840|NCT02370537|BG002|Baseline|Normal FEC (EPANOVA® and OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
11029910|NCT01203774|OG001|Outcome|Group 2: Syringe-administered Then Pen-administered Glargine|"Syringe-administered Glargine insulin and then pen-administered Glargine insulin~Glargine insulin: 20-180 units per day"
11029911|NCT01203774|EG000|Reported Event|Pen-administered Glargine|Glargine insulin: 20-180 units per day
11029912|NCT01203774|EG001|Reported Event|Syringe-administered Glargine|Glargine insulin: 20-180 units per day
11029913|NCT01203787|BG000|Baseline|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
11029914|NCT01203787|BG001|Baseline|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13, 200 mg twice daily from Day 14-Day 20, 600 mg daily from Day 21-Day 27, 400 mg twice daily beginning Day 28 until end of treatment or Week 24
11029915|NCT01203787|BG002|Baseline|Total|Total of all reporting groups
11029916|NCT01203787|FG000|Participant Flow|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
11029917|NCT01203787|FG001|Participant Flow|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
11029918|NCT01203787|OG000|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
11029919|NCT01203787|OG001|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
11029920|NCT01203787|OG000|Outcome|Sorafenib Standard Dosing Regimen|"Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24~Sorafenib Ramp-Up Regimen: 200 mg daily, Day 0-Day 13 200 mg twice daily, Day 14-Day 20 600 mg daily, Day 21-Day 27 400 mg twice daily, Day 28 until end of treatment400 mg twice daily"
11029921|NCT01203787|OG001|Outcome|Sorafenib Ramp-Up Regimen|"200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24~Sorafenib Standard Dosing Regimen: Sorafenib 400 mg twice daily until wk 24 or end of treatment"
11029922|NCT01203787|EG000|Reported Event|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
11029923|NCT01203787|EG001|Reported Event|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
11029924|NCT01203826|BG000|Baseline|2 mg/kg Asfotase Alfa|Dose group shown is as per patient's randomization in Study ENB-006-09
11029925|NCT01203826|BG001|Baseline|3 mg/kg Asfotase Alfa|Dose group shown is as per patient's randomization in Study ENB-006-09
11029926|NCT01203826|BG002|Baseline|Total|Total of all reporting groups
11029927|NCT01203826|FG000|Participant Flow|2 mg/kg Asfotase Alfa|The starting dose of asfotase alfa was 3 mg/kg/week for all patients in Study ENB-008-10 and was subsequently increased per study-wide dose adjustment to a total dose of 6 mg/kg/week. Results are shown by the patient's dose group assignment from Study ENB-006-09.
11029928|NCT01203826|FG001|Participant Flow|3 mg/kg Asfotase Alfa|The starting dose of asfotase alfa was 3 mg/kg/week for all patients in Study ENB-008-10 and was subsequently increased per study-wide dose adjustment to a total dose of 6 mg/kg/week. Results are shown by the patient's dose group assignment from Study ENB-006-09.
11029929|NCT01203826|OG000|Outcome|Asfotase Alfa Combined|ITT population for Study ENB-008-10, which included all patients that received treatment with asfotase alfa.
11029930|NCT01203826|EG000|Reported Event|2 mg/kg Asfotase Alfa|Dose group shown is as per patient's randomization in Study ENB-006-09.
11029931|NCT01203826|EG001|Reported Event|3 mg/kg Asfotase Alfa|Dose group shown is as per patient's randomization in Study ENB-006-09.
11029932|NCT01203826|EG002|Reported Event|Combined Asfotase Alfa Group|All patients treated with asfotase alfa during Study ENB-008-10
11029933|NCT01203852|BG000|Baseline|Metoprolol + Chlorthalidone|"This group was assigned to the following: Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their HBP average or OBP is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks. Then will washout from all study medication. After washout, participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks.~Metoprolol: Metoprolol 50 mg twice daily titrated to 100 mg twice daily~Chlorthalidone: Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily~Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily."
11029934|NCT01203852|FG000|Participant Flow|Metoprolol + Chlorthalidone|"This group was assigned the following:~(Metoprolol 8 weeks): Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their home blood pressure (HBP) average or office blood pressure (OBP) is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks.~(Washout 2 weeks): Then will washout from all study medication.~(Chlorthalidone 8 weeks): participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks."
11029935|NCT01203852|OG000|Outcome|Metoprolol + Chlorthalidone|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient's hypertension was re-established. After another set of identical baseline labs, study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
11029936|NCT01203852|OG001|Outcome|Metorprolol Only|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded.
11029937|NCT01203852|OG002|Outcome|Chlorthalidone Only|Study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
11029938|NCT01203852|OG000|Outcome|Adverse Metabolic Effects|Change in glucose after treatment with study medications
11029939|NCT01203852|EG000|Reported Event|All Study Participants|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient's hypertension was re-established. The subjects were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
11225841|NCT02370537|BG003|Baseline|Total|Total of all reporting groups
11029940|NCT01203878|BG000|Baseline|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
11029941|NCT01203878|BG001|Baseline|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
11029942|NCT01203878|BG002|Baseline|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period,
11029943|NCT01203878|BG003|Baseline|Total|Total of all reporting groups
11029944|NCT01203878|FG000|Participant Flow|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
11029945|NCT01203878|FG001|Participant Flow|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
11029946|NCT01203878|FG002|Participant Flow|Non-randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period
11029947|NCT01203878|OG000|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
11029948|NCT01203878|OG001|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
11029949|NCT01203878|EG000|Reported Event|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
11029950|NCT01203878|EG001|Reported Event|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
11029951|NCT01203878|EG002|Reported Event|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period.
11029952|NCT01203917|BG000|Baseline|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
11029953|NCT01203917|FG000|Participant Flow|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
11029954|NCT01203917|OG000|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
11029955|NCT01203917|EG000|Reported Event|Gefitinib 250 mg|
11029956|NCT01203930|BG000|Baseline|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
11029957|NCT01203930|BG001|Baseline|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
11029958|NCT01203930|BG002|Baseline|Total|Total of all reporting groups
11029959|NCT01203930|FG000|Participant Flow|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
11029960|NCT01203930|FG001|Participant Flow|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
11029961|NCT01203930|OG000|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
11029962|NCT01203930|OG001|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
11150226|NCT01876446|OG000|Outcome|A: Chemo Resistant|"Group A: chemo resistant - those progressing on first-line therapy < 3 months after completion of treatment.~Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies"
11029963|NCT01203930|OG000|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
11029964|NCT01203930|OG000|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
11029965|NCT01203930|EG000|Reported Event|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
11029966|NCT01203930|EG001|Reported Event|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
11029967|NCT01203956|BG000|Baseline|All Evaluable Subjects|All subjects completing both two-week periods of crossover study, with evaluable results for each period.
11029968|NCT01203956|FG000|Participant Flow|SmartFlex First, Then Standard|First two weeks with Smartflex engaged, second two weeks without Smartflex engaged
11029969|NCT01203956|FG001|Participant Flow|Standard First, Then Smartflex|First two weeks without Smartflex engaged, second two weeks with Smartflex engaged
11029970|NCT01203956|OG000|Outcome|SmartFlex|Used CPAP device with SmartFlex engaged, in either first or second two-week period.
11029971|NCT01203956|OG001|Outcome|Standard|Used CPAP device without SmartFlex engaged, in either first or second two-week period.
11029972|NCT01203956|EG000|Reported Event|SmartFlex|CPAP device used with SmartFlex engaged, either in first or second two-week period.
11029973|NCT01203956|EG001|Reported Event|Standard|CPAP device used without SmartFlex engaged, either in first or second two-week period.
11029974|NCT01203956|EG002|Reported Event||From data available it cannot be determined which mode the subject was using at the time of this event.
11029975|NCT01204203|BG000|Baseline|Zoledronic Acid (Zometa)|Zometa (zoledronic acid) 4mg will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
11029976|NCT01204203|FG000|Participant Flow|Zoledronic Acid (Zometa)|"Zoledronic acid (Zometa) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zoledronic acid (Zometa) will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
11029977|NCT01204203|OG000|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
11029978|NCT01204203|EG000|Reported Event|Zoledronic Acid (Zometa)|Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.
11029979|NCT01204255|BG000|Baseline|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
11029980|NCT01204255|FG000|Participant Flow|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
11029981|NCT01204255|OG000|Outcome|Application of Lorazepam, Diphenhydramine, Haloperidol|Topical application of lorazepam, diphenhydramine, haloperidol
11029982|NCT01204255|EG000|Reported Event|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
11029983|NCT01204294|BG000|Baseline|Bigu+Lina|biguanide plus linagliptin
11029984|NCT01204294|BG001|Baseline|Glin+Lina|glinide plus linagliptin
11029985|NCT01204294|BG002|Baseline|Glit+Lina|glitazone plus linagliptin
11029986|NCT01204294|BG003|Baseline|SU+Lina|sulfonylurea plus linagliptin
11029987|NCT01204294|BG004|Baseline|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
11029988|NCT01204294|BG005|Baseline|SU+Met|sulfonylurea plus metformin
11029989|NCT01204294|BG006|Baseline|A-GI+Met|alpha-glucosidase inhibitor plus metformin
11029990|NCT01204294|BG007|Baseline|Total|Total of all reporting groups
11029991|NCT01204294|FG000|Participant Flow|Bigu+Lina|biguanide plus linagliptin
11029992|NCT01204294|FG001|Participant Flow|Glin+Lina|glinide plus linagliptin
11029993|NCT01204294|FG002|Participant Flow|Glit+Lina|glitazone plus linagliptin
11029994|NCT01204294|FG003|Participant Flow|SU+Lina|sulfonylurea plus linagliptin
11029995|NCT01204294|FG004|Participant Flow|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
11029996|NCT01204294|FG005|Participant Flow|SU+Met|sulfonylurea plus metformin
11029997|NCT01204294|FG006|Participant Flow|A-GI+Met|alpha-glucosidase inhibitor plus metformin
11029998|NCT01204294|OG000|Outcome|Bigu+Lina|biguanide plus linagliptin
11029999|NCT01204294|OG001|Outcome|Glin+Lina|glinide plus linagliptin
11030000|NCT01204294|OG002|Outcome|Glit+Lina|glitazone plus linagliptin
11030001|NCT01204294|OG003|Outcome|SU+Lina|sulfonylurea plus linagliptin
11030002|NCT01204294|OG004|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
11030003|NCT01204294|OG005|Outcome|SU+Met|sulfonylurea plus metformin
11030004|NCT01204294|OG006|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
11030005|NCT01204294|EG000|Reported Event|Bigu+Lina|biguanide plus linagliptin
11030006|NCT01204294|EG001|Reported Event|Glin+Lina|glinide plus linagliptin
11030007|NCT01204294|EG002|Reported Event|Glit+Lina|glitazone plus linagliptin
11030008|NCT01204294|EG003|Reported Event|SU+Lina|sulfonylurea plus linagliptin
11030009|NCT01204294|EG004|Reported Event|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
11030010|NCT01204294|EG005|Reported Event|SU+Met|sulfonylurea plus metformin
11030011|NCT01204294|EG006|Reported Event|A-GI+Met|alpha-glucosidase inhibitor plus metformin
11030012|NCT01204398|BG000|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11030013|NCT01204398|FG000|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11030014|NCT01204398|OG000|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
11030015|NCT01204398|EG000|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
11030016|NCT01204658|BG000|Baseline|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030017|NCT01204658|BG001|Baseline|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030018|NCT01204658|BG002|Baseline|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
11030019|NCT01204658|BG003|Baseline|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
11030020|NCT01204658|BG004|Baseline|Total|Total of all reporting groups
11030021|NCT01204658|FG000|Participant Flow|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030022|NCT01204658|FG001|Participant Flow|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030023|NCT01204658|FG002|Participant Flow|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
11030024|NCT01204658|FG003|Participant Flow|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
11030025|NCT01204658|OG000|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030026|NCT01204658|OG001|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030027|NCT01204658|OG002|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
11030028|NCT01204658|OG003|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
11030029|NCT01204658|OG001|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
11030030|NCT01204658|OG000|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030031|NCT01204658|OG000|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™
11030032|NCT01204658|EG000|Reported Event|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030033|NCT01204658|EG001|Reported Event|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
11030034|NCT01204658|EG002|Reported Event|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
11030035|NCT01204658|EG003|Reported Event|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
11030036|NCT01204671|BG000|Baseline|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030037|NCT01204671|BG001|Baseline|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030038|NCT01204671|BG002|Baseline|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030039|NCT01204671|BG003|Baseline|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030040|NCT01204671|BG004|Baseline|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030041|NCT01204671|BG005|Baseline|Total|Total of all reporting groups
11150227|NCT01876446|OG001|Outcome|B: Chemo Sensitive|"Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.~Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Pegylated Irinotecan: Given IV~Pharmacological Study: Correlative studies"
11030042|NCT01204671|FG000|Participant Flow|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030043|NCT01204671|FG001|Participant Flow|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030044|NCT01204671|FG002|Participant Flow|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030045|NCT01204671|FG003|Participant Flow|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030046|NCT01204671|FG004|Participant Flow|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030047|NCT01204671|OG000|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030048|NCT01204671|OG001|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030049|NCT01204671|OG002|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030050|NCT01204671|OG000|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030051|NCT01204671|OG001|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
10887344|NCT00499889|EG000|Reported Event|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
11030052|NCT01204671|OG002|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030053|NCT01204671|OG003|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030054|NCT01204671|OG004|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030055|NCT01204671|OG001|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11030056|NCT01204671|EG000|Reported Event|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030057|NCT01204671|EG001|Reported Event|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030058|NCT01204671|EG002|Reported Event|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030059|NCT01204671|EG003|Reported Event|Fluarix Group|Subjects received one dose of the 1 dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030060|NCT01204671|EG004|Reported Event|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
11030061|NCT01204697|BG000|Baseline|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
11030062|NCT01204697|BG001|Baseline|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
11030063|NCT01204697|BG002|Baseline|Total|Total of all reporting groups
11030064|NCT01204697|FG000|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.
11030065|NCT01204697|FG001|Participant Flow|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
11030066|NCT01204697|OG000|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
11148985|NCT01868074|FG000|Participant Flow|Customized Insole Group|"Each participant in the intervention group had her insole customized to fit her typical daily footwear and was instructed to wear the insoles as often as possible. Participants in the intervention group had their feet molded by a certified orthotist, using a 3M, soft cast. The casting was done in a non-weight bearing, hind-foot neutral position so the insoles would preserve the long transverse arch and maintain a biomechanically efficient state to control motion at the foot and ankle. These castings were used to custom form insoles with the following characteristics: Footlights athletic or dress model (per participant shoe preference), with 3/16 semi-rigid shells, no arch fill, extrinsic rearfoot and standard intrinsic forefoot posting. A research team member not involved with outcome measurements met with the participants to give them their insoles and confirm they fit."
11148986|NCT01868074|FG001|Participant Flow|Usual Care Group|Participants in the control group were instructed to wear their usual footwear over the course of their pregnancy.
11148987|NCT01868074|OG000|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
11148988|NCT01868074|OG001|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
11148989|NCT01868074|EG000|Reported Event|Customized Insole|These participants were casted for customized insoles.
11148990|NCT01868074|EG001|Reported Event|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
11148991|NCT01868165|BG000|Baseline|Older Adult Cohort|Older adults receiving treatment with antihypertensive medication
11148992|NCT01868165|FG000|Participant Flow|Older Adult Cohort|Older adults receiving treatment with antihypertensive medication
11148993|NCT01868165|OG000|Outcome|Older Adult Cohort|Older adult cohort receiving antihypertensive medication
11148994|NCT01868165|EG000|Reported Event|Older Adult Cohort|Older adults receiving antihypertensive medication
11148995|NCT01868243|BG000|Baseline|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg (50 patients)"
11148996|NCT01868243|BG001|Baseline|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose"
11148997|NCT01868243|BG002|Baseline|Total|Total of all reporting groups
11148998|NCT01868243|FG000|Participant Flow|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
11148999|NCT01868243|FG001|Participant Flow|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
11149000|NCT01868243|OG000|Outcome|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
11149001|NCT01868243|OG001|Outcome|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
11149002|NCT01868243|EG000|Reported Event|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
11149003|NCT01868243|EG001|Reported Event|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
11149004|NCT01868334|BG000|Baseline|Pittsburgh Intervention|"Practices: Represents 10 clinical practices engaged in active intervention in Year 1.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza)."
11149005|NCT01868334|BG001|Baseline|Pittsburgh Control/Maintenance|"Practices: Represents 8 clinical practices who were control practices in Year 1 and who received the intervention in Year 2.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza)."
11149006|NCT01868334|BG002|Baseline|Houston Intervention|"Practices: Represents 3 clinical practices engaged in active intervention in Year 1.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza)."
11149007|NCT01868334|BG003|Baseline|Houston Control/Maintenance|"Practices: Represents 3 clinical practices who were control practices in Year 1 and who received the intervention in Year 2.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza)."
11149008|NCT01868334|BG004|Baseline|Total|Total of all reporting groups
11150228|NCT01876446|EG000|Reported Event|A: Chemo Resistant|"Group A: chemo resistant - those progressing on first-line therapy < 3 months after completion of treatment.~Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies"
11149009|NCT01868334|FG000|Participant Flow|Pittsburgh Intervention Sites|"Practices: Clinical practices were stratified by metropolitan area (e.g., Pittsburgh) and then randomized into the intervention or control arms within strata.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, PCV) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 1 RCCT Study: Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult vaccination rates (N=10).~Year 2 Pre-post study: Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult vaccination rates."
11149010|NCT01868334|FG001|Participant Flow|Pittsburgh Control/Maintenance Sites|"Practices: Clinical practices were stratified by metropolitan area (e.g., Pittsburgh) and then randomized into the intervention or control arms within strata.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, PCV) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 1 RCCT study: Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8).~Year 2 Pre-post study: Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult vaccination rates during Year 2 (N=6)."
11149011|NCT01868334|FG002|Participant Flow|Houston Intervention Sites|"Practices: Clinical practices were stratified by metropolitan area (e.g., Houston) and then randomized into the intervention or control arms within strata.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, PCV) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 1 RCCT study: Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult vaccination rates (N=3).~Year 2 Pre-post study: Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to increase adult vaccination rates."
11149012|NCT01868334|FG003|Participant Flow|Houston Control/Maintenance Sites|"Practices: Clinical practices were stratified by metropolitan area (e.g., Houston) and then randomized into the intervention or control arms within strata.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, PCV) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 1 RCCT study: Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3).~Year 2 Pre-post study: Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult vaccination rates during Year 2 (N=3)."
11149013|NCT01868334|OG000|Outcome|Year 1 RCCT Pittsburgh Intervention Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=10)."
11149014|NCT01868334|OG001|Outcome|Year 1 RCCT Pittsburgh Control Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
11149015|NCT01868334|OG002|Outcome|Year 1 RCCT Pittsburgh Intervention Sites - Pneumococcal Vacc|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=10)."
11149016|NCT01868334|OG003|Outcome|Year 1 RCCT Pittsburgh Control Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
11149017|NCT01868334|OG004|Outcome|Year 1 RCCT Pittsburgh Intervention Sites - Influenza Vaccine|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=10)."
11149018|NCT01868334|OG005|Outcome|Year 1 RCCT Pittsburgh Control Sites - Influenza Vaccine|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
11149019|NCT01868334|OG006|Outcome|Year 1 RCCT Houston Intervention Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=3)."
11149020|NCT01868334|OG007|Outcome|Year 1 RCCT Houston Control Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
11149021|NCT01868334|OG008|Outcome|Year 1 RCCT Houston Intervention Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=3)."
11149022|NCT01868334|OG009|Outcome|Year 1 RCCT Houston Control Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
11149023|NCT01868334|OG010|Outcome|Year 1 RCCT Houston Intervention Sites - Influenza Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=3)."
11149024|NCT01868334|OG011|Outcome|Year 1 RCCT Houston Control Sites - Influenza Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
11149025|NCT01868334|OG000|Outcome|Year 2 Pre-post Study Pittsburgh Intervention Sites - Tdap|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult Tdap vaccination rates."
11149026|NCT01868334|OG001|Outcome|Year 2 Pre-post Study Pittsburgh Maintenance Sites - Tdap|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult Tdap vaccination rates during Year 2 (N=6)."
11149027|NCT01868334|OG002|Outcome|Year 2 Pre-post Study Pittsburgh Intervention Sites - PPSV|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult pneumococcal vaccination rates."
11149028|NCT01868334|OG003|Outcome|Year 2 Pre-post Study Pittsburgh Maintenance Sites - PPSV|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult pneumococcal vaccination rates during Year 2 (N=6)."
11149029|NCT01868334|OG004|Outcome|Year 2 Pre-post Study Pittsburgh Intervention Sites-Influenza|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult influenza vaccination rates."
11149030|NCT01868334|OG005|Outcome|Year 2 Pre-post Study Pittsburgh Maintenance Sites - Influenza|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult influenza vaccination rates during Year 2 (N=6)."
11149031|NCT01868334|OG006|Outcome|Year 2 Pre-post Study Houston Intervention Sites - Tdap|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to increase adult Tdap vaccination rates."
11149032|NCT01868334|OG007|Outcome|Year 2 Pre-post Study Houston Maintenance Sites - Tdap|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult Tdap vaccination rates during Year 2 (N=3)."
11149033|NCT01868334|OG008|Outcome|Year 2 Pre-post Study Houston Intervention Sites - PPSV|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to raise adult pneumococcal vaccination rates."
11149034|NCT01868334|OG009|Outcome|Year 2 Pre-post Study Houston Maintenance Sites - PPSV|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult pneumococcal vaccination rates during Year 2 (N=3)."
11149035|NCT01868334|OG010|Outcome|Year 2 Pre-post Study Houston Intervention Sites - Influenza|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to increase adult influenza vaccination rates."
11149036|NCT01868334|OG011|Outcome|Year 2 Pre-post Study Houston Maintenance Sites - Influenza|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult influenza vaccination rates during Year 2 (N=3)."
11149037|NCT01868334|EG000|Reported Event|Year 1 RCCT Pittsburgh Intervention Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=10)."
11149038|NCT01868334|EG001|Reported Event|Year 1 RCCT Pittsburgh Control Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
11149039|NCT01868334|EG002|Reported Event|Year 1 RCCT Pittsburgh Intervention Sites - Pneumococcal Vacc|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=10)."
11149040|NCT01868334|EG003|Reported Event|Year 1 RCCT Pittsburgh Control Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
11149041|NCT01868334|EG004|Reported Event|Year 1 RCCT Pittsburgh Intervention Sites - Influenza Vaccine|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=10)."
11149042|NCT01868334|EG005|Reported Event|Year 1 RCCT Pittsburgh Control Sites - Influenza Vaccine|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
11149043|NCT01868334|EG006|Reported Event|Year 1 RCCT Houston Intervention Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=3)."
11149044|NCT01868334|EG007|Reported Event|Year 1 RCCT Houston Control Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
11149045|NCT01868334|EG008|Reported Event|Year 1 RCCT Houston Intervention Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=3)."
11149046|NCT01868334|EG009|Reported Event|Year 1 RCCT Houston Control Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
11149047|NCT01868334|EG010|Reported Event|Year 1 RCCT Houston Intervention Sites - Influenza Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=3)."
11149048|NCT01868334|EG011|Reported Event|Year 1 RCCT Houston Control Sites - Influenza Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
11149049|NCT01868425|BG000|Baseline|Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine|"aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane~multimodal:acetaminophen, gabapentin, ketamine, bupivacaine: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane"
11149050|NCT01868425|BG001|Baseline|Placebo Pills and Injectables|"standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane~placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds"
11149051|NCT01868425|BG002|Baseline|Total|Total of all reporting groups
11030067|NCT01204697|OG001|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
11030068|NCT01204697|EG000|Reported Event|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
11030069|NCT01204697|EG001|Reported Event|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
11030070|NCT01204710|BG000|Baseline|Olaratumab + Mitoxantrone|"15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²).~After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met."
11030071|NCT01204710|BG001|Baseline|Mitoxantrone: Optional Olaratumab Monotherapy|"12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²).~Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met."
11030072|NCT01204710|BG002|Baseline|Total|Total of all reporting groups
11030073|NCT01204710|FG000|Participant Flow|Olaratumab (IMC-3G3) + Mitoxantrone|"15 milligrams per kilogram (mg/kg) olaratumab was administered intravenously (IV) on Days 1 and 8 of each 21-day cycle, followed by 12 milligrams per square meter (mg/m²) mitoxantrone IV on Day 1 of each 21-day cycle with 5 milligrams (mg) prednisone orally (PO) twice daily (BID) on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²).~After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met."
11030074|NCT01204710|FG001|Participant Flow|Mitoxantrone: Optional Olaratumab Monotherapy|"12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²).~Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met."
11030075|NCT01204710|OG000|Outcome|Olaratumab + Mitoxantrone|"15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²).~After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met."
11030076|NCT01204710|OG001|Outcome|Mitoxantrone|"12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)."
11030077|NCT01204710|OG002|Outcome|Mitoxantrone: Optional Olaratumab Monotherapy|"12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²).~Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met."
11030078|NCT01204710|OG000|Outcome|Olaratumab + Mitoxantrone (HE)|Participants with CTC counts ≥5 cells/7.5 mL at baseline received 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²).
11030079|NCT01204710|OG001|Outcome|Mitoxantrone (HE)|"12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)."
11030080|NCT01204710|OG002|Outcome|Olaratumab + Mitoxantrone (LE)|Participants with CTC counts <5 cells/7.5 mL at baseline received 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²).
11030081|NCT01204710|OG003|Outcome|Mitoxantrone (LE)|"12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)."
11030082|NCT01204710|OG000|Outcome|Olaratumab+ Mitoxantrone|"15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²).~After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met."
11030083|NCT01204710|EG000|Reported Event|Olaratumab + Mitoxantrone|"15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²).~After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met."
11030084|NCT01204710|EG001|Reported Event|Mitoxantrone|"12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)."
11030085|NCT01204710|EG002|Reported Event|Mitoxantrone: Optional Olaratumab Monotherapy|"12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.~Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²).~Participants who experienced PD had the option to receive olaratumab monotherapy treatment.15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met."
11030086|NCT01204736|BG000|Baseline|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
11030087|NCT01204736|BG001|Baseline|Group 2|Subjects with biceps-to-triceps tendon transfers
11030088|NCT01204736|BG002|Baseline|Group 3|Subjects with cervical SCI who have not had tendon transfers
11030089|NCT01204736|BG003|Baseline|Group 4|Unimpaired control subjects
11030090|NCT01204736|BG004|Baseline|Total|Total of all reporting groups
11030091|NCT01204736|FG000|Participant Flow|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
11030092|NCT01204736|FG001|Participant Flow|Group 2|Subjects with biceps-to-triceps tendon transfers
11030093|NCT01204736|FG002|Participant Flow|Group 3|Subjects with cervical SCI who have not had tendon transfers
11030094|NCT01204736|FG003|Participant Flow|Group 4|Unimpaired control subjects
11030095|NCT01204736|OG000|Outcome|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
11030096|NCT01204736|OG001|Outcome|Group 2|Subjects with biceps-to-triceps tendon transfers
11030097|NCT01204736|OG002|Outcome|Group 3|Subjects with cervical SCI who have not had tendon transfers
11030098|NCT01204736|OG003|Outcome|Group 4|Unimpaired control subjects
11030099|NCT01204736|EG000|Reported Event|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
11030100|NCT01204736|EG001|Reported Event|Group 2|Subjects with biceps-to-triceps tendon transfers
11030101|NCT01204736|EG002|Reported Event|Group 3|Subjects with cervical SCI who have not had tendon transfers
11030102|NCT01204736|EG003|Reported Event|Group 4|Unimpaired control subjects
11030103|NCT01204775|BG000|Baseline|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
11030104|NCT01204775|BG001|Baseline|Placebo|Placebo matching saxagliptin
11030105|NCT01204775|BG002|Baseline|Total|Total of all reporting groups
11030106|NCT01204775|FG000|Participant Flow|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
11030107|NCT01204775|FG001|Participant Flow|Placebo|Placebo matching saxagliptin
11030108|NCT01204775|OG000|Outcome|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
11030109|NCT01204775|OG001|Outcome|Placebo|Placebo matching saxagliptin
11030110|NCT01204775|EG000|Reported Event|Placebo|Placebo matching saxagliptin
11030111|NCT01204775|EG001|Reported Event|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
11030112|NCT01204853|BG000|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
11030113|NCT01204853|FG000|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
11030114|NCT01204853|OG000|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
11030115|NCT01204853|EG000|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
11030116|NCT01204905|BG000|Baseline|Open Label ART|"Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.~Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart~Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart"
11030117|NCT01204905|FG000|Participant Flow|Open Label ART|"Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.~Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart~Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart"
11030118|NCT01204905|OG000|Outcome|Open Label ART|"Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.~Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart~Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart"
11030119|NCT01204905|EG000|Reported Event|Open Label ART|"Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.~Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart~Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart"
11030120|NCT01204918|BG000|Baseline|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
11030121|NCT01204918|BG001|Baseline|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
11030122|NCT01204918|BG002|Baseline|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
11030123|NCT01204918|BG003|Baseline|Total|Total of all reporting groups
11030124|NCT01204918|FG000|Participant Flow|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
11030125|NCT01204918|FG001|Participant Flow|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
11030126|NCT01204918|FG002|Participant Flow|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
11030127|NCT01204918|OG000|Outcome|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
11030128|NCT01204918|OG001|Outcome|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
11030129|NCT01204918|OG002|Outcome|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
11030130|NCT01204918|EG000|Reported Event|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
11030131|NCT01204918|EG001|Reported Event|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
11030132|NCT01204918|EG002|Reported Event|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
11030133|NCT01205035|BG000|Baseline|Observation|Observation; No treatment given
11030134|NCT01205035|BG001|Baseline|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
11030135|NCT01205035|BG002|Baseline|Total|Total of all reporting groups
11030136|NCT01205035|FG000|Participant Flow|Observation|Observation; No treatment given
11030137|NCT01205035|FG001|Participant Flow|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
11030138|NCT01205035|OG000|Outcome|Observation|Observation; No treatment given
11030139|NCT01205035|OG001|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
11030140|NCT01205035|EG000|Reported Event|Observation|Observation; No treatment given
11030141|NCT01205035|EG001|Reported Event|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
11030142|NCT01205126|BG000|Baseline|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
11030143|NCT01205126|BG001|Baseline|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
11030144|NCT01205126|BG002|Baseline|Total|Total of all reporting groups
11030145|NCT01205126|FG000|Participant Flow|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
11030146|NCT01205126|FG001|Participant Flow|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
10887345|NCT00499915|BG000|Baseline|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
11030147|NCT01205126|OG000|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
11030148|NCT01205126|OG001|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
11030149|NCT01205126|EG000|Reported Event|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
11030150|NCT01205126|EG001|Reported Event|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
11030151|NCT01205152|BG000|Baseline|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
11030152|NCT01205152|FG000|Participant Flow|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
11030153|NCT01205152|OG000|Outcome|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
11030154|NCT01205152|OG000|Outcome|Asfotase Alfa (Baseline ENB-002-08)|Baseline results prior to treatment with asfotase alfa
11030155|NCT01205152|OG001|Outcome|Asfotase Alfa (Last Assessment)|Results at the last assessment in the ENB-003-08 study.
11030156|NCT01205152|EG000|Reported Event|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
11030157|NCT01205165|BG000|Baseline|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
11030158|NCT01205165|FG000|Participant Flow|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 milligram (mg) Adefovir dipivoxil, orally once daily for 52-weeks
11030159|NCT01205165|OG000|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
11030160|NCT01205165|OG000|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
11030161|NCT01205165|EG000|Reported Event|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
11030162|NCT01205230|BG000|Baseline|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
11030163|NCT01205230|BG001|Baseline|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
11030164|NCT01205230|BG002|Baseline|Total|Total of all reporting groups
11030165|NCT01205230|FG000|Participant Flow|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
11030166|NCT01205230|FG001|Participant Flow|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
11030167|NCT01205230|OG000|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
11030168|NCT01205230|OG001|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
11030169|NCT01205230|OG002|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
11030170|NCT01205230|OG003|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
11030171|NCT01205230|OG000|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
11030172|NCT01205230|EG000|Reported Event|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
11030173|NCT01205230|EG001|Reported Event|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
11030174|NCT01205230|EG002|Reported Event|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
11030175|NCT01205230|EG003|Reported Event|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
11030176|NCT01205269|BG000|Baseline|Entire Study Population|Includes all groups randomized to one of 6 sequences of drug or placebo.
11030177|NCT01205269|FG000|Participant Flow|First 50 mcg, Then 200 mcg, Then Placebo|period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo
11030178|NCT01205269|FG001|Participant Flow|First 50 mcg, Then Placebo, Then 200 mcg|period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
11030179|NCT01205269|FG002|Participant Flow|First 200 mcg, Then Placebo, Then 50 mcg|period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
11030180|NCT01205269|FG003|Participant Flow|First 200 mcg, Then 50 mcg, Then Placebo|period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
11030181|NCT01205269|FG004|Participant Flow|First Placebo, Then 200 mcg, Then 50 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
11030182|NCT01205269|FG005|Participant Flow|First Placebo, Then 50 mcg, Then 200 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
11030183|NCT01205269|OG000|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
11030184|NCT01205269|OG001|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
11030185|NCT01205269|OG002|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
11030186|NCT01205269|EG000|Reported Event|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
11030187|NCT01205269|EG001|Reported Event|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
11030188|NCT01205269|EG002|Reported Event|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
11030189|NCT01205399|BG000|Baseline|AlloMax Surgical Graft Group|
11030190|NCT01205399|FG000|Participant Flow|AlloMax Surgical Graft Group|The study group included eligible subjects who underwent hernia repair using the AlloMax™ Surgical Graft at least 9 months prior to the start of this study.
11030191|NCT01205399|OG000|Outcome|AlloMax Surgical Graft Group|
11030192|NCT01205399|EG000|Reported Event|AlloMax Surgical Graft Group|
11030193|NCT01205438|BG000|Baseline|LY2127399 Every 2 Weeks|120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
11030194|NCT01205438|BG001|Baseline|LY2127399 Every 4 Weeks|"During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.~120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug~Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks."
11030195|NCT01205438|BG002|Baseline|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
11030196|NCT01205438|BG003|Baseline|Total|Total of all reporting groups
11030197|NCT01205438|FG000|Participant Flow|LY2127399 Every 2 Weeks|120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
11030198|NCT01205438|FG001|Participant Flow|LY2127399 Every 4 Weeks|"During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.~120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug~Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks."
11030199|NCT01205438|FG002|Participant Flow|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
11030200|NCT01205438|OG000|Outcome|LY2127399 Every 2 Weeks|LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
11149052|NCT01868425|FG000|Participant Flow|Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine|"aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane~multimodal:acetaminophen, gabapentin, ketamine, bupivacaine: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane"
11030201|NCT01205438|OG001|Outcome|LY2127399 Every 4 Weeks|"During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.~LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug~Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks."
11030202|NCT01205438|OG002|Outcome|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
11030203|NCT01205438|EG000|Reported Event|LY2127399 Every 2 Weeks|LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
11030204|NCT01205438|EG001|Reported Event|LY2127399 Every 4 Weeks|"During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.~LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug~Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks."
11030205|NCT01205438|EG002|Reported Event|Placebo|Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
11030206|NCT01205438|EG003|Reported Event|LY2127399 Every 2 Weeks, Follow Up|24-48 weeks post last dose for participants receiving LY2127399 every 2 weeks during the Treatment Period.
11030207|NCT01205438|EG004|Reported Event|LY2127399 Every 4 Wks, Follow Up|24-48 weeks post last dose for participants receiving LY2127399 every 4 weeks during the Treatment Period.
11030208|NCT01205438|EG005|Reported Event|Placebo, Follow Up|24-48 weeks post last dose for participants receiving placebo during the Treatment Period.
11030209|NCT01205451|BG000|Baseline|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11030210|NCT01205451|BG001|Baseline|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11030211|NCT01205451|BG002|Baseline|Total|Total of all reporting groups
11030212|NCT01205451|FG000|Participant Flow|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11030213|NCT01205451|FG001|Participant Flow|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11030214|NCT01205451|OG000|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11030215|NCT01205451|OG001|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11030216|NCT01205451|EG000|Reported Event|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11030217|NCT01205451|EG001|Reported Event|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
11030218|NCT01205503|BG000|Baseline|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
11030219|NCT01205503|BG001|Baseline|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
11149053|NCT01868425|FG001|Participant Flow|Placebo Pills and Injectables|"standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane~placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds"
11030220|NCT01205503|BG002|Baseline|Total|Total of all reporting groups
11030221|NCT01205503|FG000|Participant Flow|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
11030222|NCT01205503|FG001|Participant Flow|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
11030223|NCT01205503|OG000|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
11030224|NCT01205503|OG001|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
11030225|NCT01205503|EG000|Reported Event|Mesna|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
11030226|NCT01205503|EG001|Reported Event|Saline|"Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization~Infused over 15 minutes"
11030227|NCT01205529|BG000|Baseline|Atrial Fibrillation With ST Changes on Electrocardiogram|"Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will also have SCN5A mutation.~Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight."
11030228|NCT01205529|FG000|Participant Flow|Atrial Fibrillation With ST Changes on Electrocardiogram|"Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will also have SCN5A mutation.~Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight."
11030229|NCT01205529|OG000|Outcome|Atrial Fibrillation With ST Changes on Electrocardiogram|"Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will harbor cardiac sodium channel gene variants.~Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight."
11030230|NCT01205529|EG000|Reported Event|Atrial Fibrillation With ST Changes on Electrocardiogram|"Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will also have SCN5A mutation.~Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight."
11030231|NCT01205568|BG000|Baseline|Patients With Resistant Pulmonary Artery Stenosis|"Vessels with resistant PA stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.~171 vessels in 73 patients were studied. Individual participants could have vessels randomized to one or both arms of the trial."
11030232|NCT01205568|FG000|Participant Flow|Cutting Balloon (CB)|Resistant Vessels with Pulmonary Artery Stenosis were identified during catheterization and vessels were randomized to Cutting Balloon dilation.
11030233|NCT01205568|FG001|Participant Flow|High Pressure Balloon (HPB)|Resistant Vessels with Pulmonary Artery Stenosis were identified during catheterization and vessels were randomized to High Pressure Balloon dilation.
11030234|NCT01205568|OG000|Outcome|Patients With Resistant Pulmonary Artery Stenosis|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.
11030235|NCT01205568|EG000|Reported Event|Patients With Resistant Pulmonary Artery Stenosis|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon (CB) or High Pressure Balloon Dilation (HPB). Of the 73 patients, 26 received CB dilation only, 8 patients received HPB dilation only, and 39 patients received both CB and HPB dilations. Therefore, 65/73 patients were exposed to CB and 47/73 patients were exposed to HPB. Due to the overlap in treatment amongst patients, adverse events are reported on the patient level and not by intervention type.
11030236|NCT01205581|BG000|Baseline|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
11030237|NCT01205581|BG001|Baseline|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
11030238|NCT01205581|BG002|Baseline|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
11030239|NCT01205581|BG003|Baseline|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
11030240|NCT01205581|BG004|Baseline|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
11030241|NCT01205581|BG005|Baseline|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
11030242|NCT01205581|BG006|Baseline|Total|Total of all reporting groups
11030243|NCT01205581|FG000|Participant Flow|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
11030244|NCT01205581|FG001|Participant Flow|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
11030245|NCT01205581|FG002|Participant Flow|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
11030246|NCT01205581|FG003|Participant Flow|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
11030247|NCT01205581|FG004|Participant Flow|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
11030248|NCT01205581|FG005|Participant Flow|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
11030249|NCT01205581|OG000|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
11030250|NCT01205581|OG001|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
11030251|NCT01205581|OG002|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
11030252|NCT01205581|OG003|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
11030253|NCT01205581|OG004|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
11030254|NCT01205581|OG005|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
11030255|NCT01205581|OG000|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
11030256|NCT01205581|OG001|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
11030257|NCT01205581|OG000|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone HD.
11030258|NCT01205581|OG001|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone HD.
11030259|NCT01205581|OG002|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone HD.
11149054|NCT01868425|OG000|Outcome|Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine|"aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane~multimodal:acetaminophen, gabapentin, ketamine, bupivacaine: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane"
11030260|NCT01205581|OG003|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone HD.
11030261|NCT01205581|OG004|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone HD.
11030262|NCT01205581|OG005|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone HD.
11030263|NCT01205581|OG000|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone SD.
11030264|NCT01205581|OG001|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone SD.
11030265|NCT01205581|OG002|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone SD.
11030266|NCT01205581|OG003|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone SD.
11030267|NCT01205581|OG004|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone SD.
11030268|NCT01205581|OG005|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone SD.
11030269|NCT01205581|OG000|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
11030270|NCT01205581|OG001|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
11030271|NCT01205581|OG002|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
11030272|NCT01205581|EG000|Reported Event|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
11030273|NCT01205581|EG001|Reported Event|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
11030274|NCT01205581|EG002|Reported Event|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
11030275|NCT01205581|EG003|Reported Event|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
11030276|NCT01205581|EG004|Reported Event|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
11030277|NCT01205581|EG005|Reported Event|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
11030278|NCT01205646|BG000|Baseline|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
11030279|NCT01205646|FG000|Participant Flow|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
11030280|NCT01205646|OG000|Outcome|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
11030281|NCT01205646|EG000|Reported Event|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
11030282|NCT01205685|BG000|Baseline|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
11030283|NCT01205685|FG000|Participant Flow|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
11030284|NCT01205685|OG000|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
11030285|NCT01205685|EG000|Reported Event|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
11030286|NCT01205776|BG000|Baseline|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
11030287|NCT01205776|BG001|Baseline|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
11030288|NCT01205776|BG002|Baseline|Total|Total of all reporting groups
11030289|NCT01205776|FG000|Participant Flow|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
11030290|NCT01205776|FG001|Participant Flow|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
11149055|NCT01868425|OG001|Outcome|Placebo Pills and Injectables|"standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane~placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds"
11030291|NCT01205776|OG000|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
11030292|NCT01205776|OG001|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
11149056|NCT01868425|EG000|Reported Event|Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine|"aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane~multimodal:acetaminophen, gabapentin, ketamine, bupivacaine: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane"
11030293|NCT01205776|EG000|Reported Event|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
11030294|NCT01205776|EG001|Reported Event|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
11030295|NCT01205828|BG000|Baseline|Temozolomide + ABT-888|"Temozolomide and ABT-888~temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
11030296|NCT01205828|FG000|Participant Flow|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
11030297|NCT01205828|OG000|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
11030298|NCT01205828|OG000|Outcome|Temozolomide and ABT-888 in HCC Patients|"Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Temozolomide: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days~ABT-888: ABT-888 40 mg BID PO Days 1-7 every 28 days"
11030299|NCT01205828|EG000|Reported Event|Temozolomide + ABT-888|"Temozolomide and ABT-888~temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
11030300|NCT01206062|BG000|Baseline|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
11030301|NCT01206062|BG001|Baseline|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
11030302|NCT01206062|BG002|Baseline|Total|Total of all reporting groups
11030303|NCT01206062|FG000|Participant Flow|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
11030304|NCT01206062|FG001|Participant Flow|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
11030305|NCT01206062|OG000|Outcome|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
11030306|NCT01206062|OG001|Outcome|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
11030307|NCT01206062|OG000|Outcome|Intensive Control of SBP|"Participants randomized into the Intensive BP arm will have a goal of SBP <120 mm Hg. 2-drug therapy initiated in most Intensive participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic milepost visits: addition of another drug required if not at goal.~Intensive control of SBP: Participants in the Intensive arm have a goal of SBP <120 mm Hg. Use of once-daily antihypertensive agents will be encouraged unless alternative frequency is indicated/necessary."
11030308|NCT01206062|OG001|Outcome|Standard Control of SBP|"Participants randomized into the Standard arm will have a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: Participants in the Standard BP arm have a goal of SBP <140 mm Hg. The same medications used in the Intensive BP arm will be used for the Standard BP arm."
11030309|NCT01206062|EG000|Reported Event|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
11030310|NCT01206062|EG001|Reported Event|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
11030311|NCT01206140|BG000|Baseline|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11030312|NCT01206140|BG001|Baseline|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
11030313|NCT01206140|BG002|Baseline|Total|Total of all reporting groups
10887346|NCT00499915|BG001|Baseline|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
11030314|NCT01206140|FG000|Participant Flow|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11030315|NCT01206140|FG001|Participant Flow|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
11030316|NCT01206140|OG000|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
10887347|NCT00499915|BG002|Baseline|Total|Total of all reporting groups
11030317|NCT01206140|OG001|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
11030318|NCT01206140|EG000|Reported Event|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11030319|NCT01206140|EG001|Reported Event|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
11030320|NCT01206166|BG000|Baseline|Enteral Nutrition + Parenteral Nutrition|"Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).~Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated."
11030321|NCT01206166|BG001|Baseline|Enteral Nutrition Only|Enteral nutrition only - no intervention
11030322|NCT01206166|BG002|Baseline|Total|Total of all reporting groups
11030323|NCT01206166|FG000|Participant Flow|Enteral Nutrition + Parenteral Nutrition|"Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).~Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated."
11030324|NCT01206166|FG001|Participant Flow|Enteral Nutrition Only|Enteral nutrition only - no intervention
11030325|NCT01206166|OG000|Outcome|EN Only|Enteral nutrition no intervention
11030326|NCT01206166|OG001|Outcome|Enteral Nutrition + Parenteral Nutrition|"Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).~Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated."
11030327|NCT01206166|OG000|Outcome|Enteral Nutrition Only|Enteral nutrition no intervention
11030328|NCT01206166|OG000|Outcome|Enteral Nutrition Only|Enteral nutrition only - no intervention
11030329|NCT01206166|OG000|Outcome|Enteral Nutrition Only|Enteral Nutrition only-no intervention
11030330|NCT01206166|EG000|Reported Event|Enteral Nutrition + Parenteral Nutrition|"Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).~Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated."
11030331|NCT01206166|EG001|Reported Event|Enteral Nutrition Only|Enteral nutrition only - no intervention
11030332|NCT01206322|BG000|Baseline|Healthy|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
11030333|NCT01206322|BG001|Baseline|Diabetics|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
11030334|NCT01206322|BG002|Baseline|Total|Total of all reporting groups
11030335|NCT01206322|FG000|Participant Flow|Diabetes Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
11149057|NCT01868425|EG001|Reported Event|Placebo Pills and Injectables|"standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane~placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds"
11030336|NCT01206322|FG001|Participant Flow|Diabetes Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
11030337|NCT01206322|FG002|Participant Flow|Control Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
11030338|NCT01206322|FG003|Participant Flow|Control Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
11030339|NCT01206322|OG000|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
11030340|NCT01206322|OG001|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
11030341|NCT01206322|OG002|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
11030342|NCT01206322|OG003|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
11030343|NCT01206322|EG000|Reported Event|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
11030344|NCT01206322|EG001|Reported Event|Diabetes Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
11030345|NCT01206322|EG002|Reported Event|Control Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
11030346|NCT01206322|EG003|Reported Event|Control Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
11030347|NCT01206387|BG000|Baseline|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
11030348|NCT01206387|BG001|Baseline|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
11030349|NCT01206387|BG002|Baseline|Total|Total of all reporting groups
11030350|NCT01206387|FG000|Participant Flow|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
11348882|NCT04140890|OG001|Outcome|Treatment|Participants in the treatment group will be asked to meet with an occupational therapist in their home weekly over 12 weeks. Each session takes an hour. In the first session, the occupational therapist will introduce the program. In session 2, the therapist will discuss pain and pain management with the participant. In session 3-12, the therapist will help the participant to develop physical activity and healthy eating habits. In each session the participant will pick two healthy behaviors to turn them into a habit. The therapist will give the participant a workbook and teach the participant to track his/her progress. The focus of session 3-5 will be physical activity, and session 6-11 will be healthy eating. In the last session (session 12), the therapist will wrap up the program and help the participant to develop a maintenance plan.
11030351|NCT01206387|FG001|Participant Flow|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
11030352|NCT01206387|OG000|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
11030353|NCT01206387|OG001|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
11030354|NCT01206387|EG000|Reported Event|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
11030355|NCT01206387|EG001|Reported Event|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
11030356|NCT01206452|BG000|Baseline|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
11030357|NCT01206452|BG001|Baseline|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
11030358|NCT01206452|BG002|Baseline|Total|Total of all reporting groups
11030359|NCT01206452|FG000|Participant Flow|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
11030360|NCT01206452|FG001|Participant Flow|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
11030361|NCT01206452|OG000|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
11030362|NCT01206452|OG001|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
11030363|NCT01206452|EG000|Reported Event|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
11030364|NCT01206452|EG001|Reported Event|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
11030365|NCT01206465|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive pralatrexate IV over 5 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11030366|NCT01206465|FG000|Participant Flow|75 mg/m^2|pralatrexate (PDX) dose level
11030367|NCT01206465|FG001|Participant Flow|94 mg/m^2|pralatrexate (PDX) dose level
11030368|NCT01206465|FG002|Participant Flow|118 mg/m^2|pralatrexate (PDX) dose level
11030369|NCT01206465|FG003|Participant Flow|148 mg/m^2|pralatrexate (PDX) dose level
11030370|NCT01206465|FG004|Participant Flow|185 mg/m^2|pralatrexate (PDX) dose level
11030371|NCT01206465|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive pralatrexate IV over 5 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11030372|NCT01206465|OG000|Outcome|75 mg/m^2|pralatrexate (PDX) Dose level 1
11030373|NCT01206465|OG001|Outcome|94 mg/m^2|PDX Dose Level 2
11030374|NCT01206465|OG002|Outcome|118 mg/m^2|PDX Dose level 3
11030375|NCT01206465|OG003|Outcome|148 mg/m^2|PDX Dose level 4
11030376|NCT01206465|OG004|Outcome|185 mg/m^2|PDX Dose level 5
11030377|NCT01206465|OG000|Outcome|Wild Type|
11030378|NCT01206465|OG001|Outcome|Heterozygous|
11030379|NCT01206465|OG002|Outcome|Homozygous Variant|
11149058|NCT01868477|BG000|Baseline|Erythropoietin Alpha|Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
11030380|NCT01206465|OG000|Outcome|22 Hours|5 FU plasma levels
11030381|NCT01206465|OG001|Outcome|23 Hours|5 FU plasma levels
11030382|NCT01206465|OG002|Outcome|45 Hours|5 FU plasma levels
11030383|NCT01206465|OG003|Outcome|46 Hours|5 FU plasma levels
11030384|NCT01206465|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive pralatrexate IV over 5 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11030385|NCT01206478|BG000|Baseline|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
11030386|NCT01206478|BG001|Baseline|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
11030387|NCT01206478|BG002|Baseline|Total|Total of all reporting groups
11030388|NCT01206478|FG000|Participant Flow|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
11030389|NCT01206478|FG001|Participant Flow|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
11030390|NCT01206478|OG000|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
11030391|NCT01206478|OG001|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
11030392|NCT01206478|EG000|Reported Event|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
11030393|NCT01206478|EG001|Reported Event|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
11030394|NCT01206582|BG000|Baseline|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
11030395|NCT01206582|BG001|Baseline|Albumin|10 iv infusions for 8 weeks
11030396|NCT01206582|BG002|Baseline|Total|Total of all reporting groups
11030397|NCT01206582|FG000|Participant Flow|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, Illinois (IL). Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
11030398|NCT01206582|FG001|Participant Flow|Albumin|10 iv infusions for 8 weeks
11030399|NCT01206582|OG000|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
11030400|NCT01206582|OG001|Outcome|Albumin|10 iv infusions for 8 weeks
11030401|NCT01206582|EG000|Reported Event|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
11030402|NCT01206582|EG001|Reported Event|Albumin|10 iv infusions for 8 weeks
11030403|NCT01206595|BG000|Baseline|SKY0402|Low-dose, low-mid dose, and mid-dose
11030404|NCT01206595|BG001|Baseline|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030405|NCT01206595|BG002|Baseline|Total|Total of all reporting groups
11030406|NCT01206595|FG000|Participant Flow|SKY0402|Low-dose, low-mid dose, and mid-dose
11030407|NCT01206595|FG001|Participant Flow|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030408|NCT01206595|OG000|Outcome|Bupivacaine HCl|A single dose of bupivacaine HCl 125 mg was administered intraoperatively by local infiltration.
11030409|NCT01206595|OG001|Outcome|SKY0402 Low Dose (175 mg)|A single dose of SKY0402 Low Dose (175 mg) was administered intraoperatively by local infiltration.
11030410|NCT01206595|OG002|Outcome|SKY0402 Low-Mid Dose (225 mg)|A single dose of SKY0402 low-mid dose (225 mg) was administered intraoperatively by local infiltration.
11030411|NCT01206595|OG003|Outcome|SKY0402 Mid Dose (350 mg)|A single dose of SKY0402 mid dose (350 mg) was administered intraoperatively by local infiltration.
11030412|NCT01206595|EG000|Reported Event|SKY0402|Low-dose, low-mid dose, and mid-dose
11030413|NCT01206595|EG001|Reported Event|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030414|NCT01206608|BG000|Baseline|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030415|NCT01206608|BG001|Baseline|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030416|NCT01206608|BG002|Baseline|Total|Total of all reporting groups
11030417|NCT01206608|FG000|Participant Flow|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030418|NCT01206608|FG001|Participant Flow|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030419|NCT01206608|OG000|Outcome|Low-dose SKY0402 (150mg) + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of 150mg SKY0402 administration via local infiltration.
11030420|NCT01206608|OG001|Outcome|Mid-dose SKY0402 (300mg)+ Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of 150mg SKY0402 administration via local infiltration.
11030421|NCT01206608|EG000|Reported Event|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030422|NCT01206608|EG001|Reported Event|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
11030423|NCT01206660|BG000|Baseline|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
11030424|NCT01206660|BG001|Baseline|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
11030425|NCT01206660|BG002|Baseline|Total|Total of all reporting groups
11030426|NCT01206660|FG000|Participant Flow|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
11030427|NCT01206660|FG001|Participant Flow|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
11030428|NCT01206660|OG000|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
11030429|NCT01206660|OG001|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
11030430|NCT01206660|EG000|Reported Event|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
11030431|NCT01206660|EG001|Reported Event|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
11030432|NCT01206738|BG000|Baseline|Persuasive Communication|The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
11030433|NCT01206738|BG001|Baseline|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
11030434|NCT01206738|BG002|Baseline|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
11030435|NCT01206738|BG003|Baseline|Total|Total of all reporting groups
11030436|NCT01206738|FG000|Participant Flow|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
11030437|NCT01206738|FG001|Participant Flow|Alternative Intervention|"Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
11030438|NCT01206738|FG002|Participant Flow|General Information|"No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care).~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
11030439|NCT01206738|OG000|Outcome|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.~Persuasive communication: The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics."
11030440|NCT01206738|OG001|Outcome|Alternative Intervention|"This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic~Action plan: This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic"
11030441|NCT01206738|OG002|Outcome|General Information|"No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.~General intervention: No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing."
11030442|NCT01206738|OG000|Outcome|Email|GPs receiving an email invitation
11030443|NCT01206738|OG001|Outcome|Post|GPs receiving a postal invitation
11030444|NCT01206738|EG000|Reported Event|Persuasive Communication|The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
11030445|NCT01206738|EG001|Reported Event|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
11030446|NCT01206738|EG002|Reported Event|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
11030447|NCT01206764|BG000|Baseline|RAD001|Two 5 mg RAD001 tablets
11030448|NCT01206764|FG000|Participant Flow|RAD001|Two 5 mg RAD001 tablets
11030449|NCT01206764|OG000|Outcome|RAD001|Two 5 mg RAD001 tablets
11030450|NCT01206764|EG000|Reported Event|RAD001|Two 5 mg RAD001 tablets
11030451|NCT01206777|BG000|Baseline|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
11030452|NCT01206777|FG000|Participant Flow|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
11030453|NCT01206777|OG000|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
11030454|NCT01206777|EG000|Reported Event|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
11030455|NCT01206816|BG000|Baseline|Volasertib150 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib (Vol) 150 mg on Day 1 and afatinib (aftb) 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030456|NCT01206816|BG001|Baseline|Volasertib 225 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib 225 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030457|NCT01206816|BG002|Baseline|Volasertib 300 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030458|NCT01206816|BG003|Baseline|Volasertib 300 mg+Afatinib 40 mg (Schedule A)|"Schedule A : Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030459|NCT01206816|BG004|Baseline|Volasertib 300 mg+Afatinib 50 mg (Schedule B)|"Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030460|NCT01206816|BG005|Baseline|Volasertib 300 mg+Afatinib 70 mg (Schedule B)|"Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030461|NCT01206816|BG006|Baseline|Volasertib 300 mg+Afatinib 90 mg (Schedule B)|"Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030462|NCT01206816|BG007|Baseline|Total|Total of all reporting groups
11030463|NCT01206816|FG000|Participant Flow|Volasertib150 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib (Vol) 150 mg on Day 1 and afatinib (aftb) 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030464|NCT01206816|FG001|Participant Flow|Volasertib 225 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib 225 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030465|NCT01206816|FG002|Participant Flow|Volasertib 300 mg+Afatinib 30 mg (Schedule A)|"Schedule A :Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030466|NCT01206816|FG003|Participant Flow|Volasertib 300 mg+Afatinib 40 mg (Schedule A)|"Schedule A :Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030467|NCT01206816|FG004|Participant Flow|Volasertib 300 mg+Afatinib 50 mg (Schedule B)|"Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030468|NCT01206816|FG005|Participant Flow|Volasertib 300 mg+Afatinib 70 mg (Schedule B)|"Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030469|NCT01206816|FG006|Participant Flow|Volasertib 300 mg+Afatinib 90 mg (Schedule B)|"Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030470|NCT01206816|OG000|Outcome|Volasertib150 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib (Vol) 150 mg on Day 1 and afatinib (aftb) 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030471|NCT01206816|OG001|Outcome|Volasertib 225 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib 225 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030472|NCT01206816|OG002|Outcome|Volasertib 300 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030473|NCT01206816|OG003|Outcome|Volasertib 300 mg+Afatinib 40 mg (Schedule A)|"Schedule A :Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030474|NCT01206816|OG004|Outcome|Volasertib 300 mg+Afatinib 50 mg (Schedule B)|"Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030475|NCT01206816|OG005|Outcome|Volasertib 300 mg+Afatinib 70 mg (Schedule B)|"Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030476|NCT01206816|OG006|Outcome|Volasertib 300 mg+Afatinib 90 mg (Schedule B)|"Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030477|NCT01206816|OG000|Outcome|Volasertib in Combination With Afatinib (Schedule A)|"The combination of Volasertib and Afatinib were investigated in two treatment schedules (A & B). In schedule A, Dose level 1: Volasertib 150 mg and afatinib 30 mg . Dose level 2: Volasertib 225 mg and afatinib 30 mg. Dose level 3: Volasertib 300 mg and afatinib 30 mg. Dose level 4: Volasertib 300 mg and afatinib 40 mg. In schedule B , Dose level 1: Volasertib 300 mg and afatinib 50 mg. Dose level 2: Volasertib 300 mg and afatinib 70 mg. Dose level 3: Volasertib 300 mg and afatinib 90mg.~In schedule A, Volasertib was infused on Day 1 and afatinib from Day 2 to Day 21. In schedule B, Volasertib on Day 1 and afatinib pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Schedule B was depending on the outcome of the MTD determination from treatment schedule A."
11030478|NCT01206816|OG001|Outcome|Volasertib in Combination With Afatinib (Schedule B)|The combination of Volasertib and Afatinib were investigated in two treatment schedules (A & B). In schedule B , Dose level 1: Volasertib 300 mg and afatinib 50 mg. Dose level 2: Volasertib 300 mg and afatinib 70 mg. Dose level 3: Volasertib 300 mg and afatinib 90mg.
11030479|NCT01206816|OG003|Outcome|Volasertib 300 mg+Afatinib 40 mg (Schedule A)|"Schedule A : Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030480|NCT01206816|OG003|Outcome|Volasertib 300 mg+Afatinib 40 mg (Schedule A)|"Schedule A (Cycle 1):Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030481|NCT01206816|EG000|Reported Event|Volasertib150 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib (Vol) 150 mg on Day 1 and afatinib (aftb) 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030482|NCT01206816|EG001|Reported Event|Volasertib 225 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib 225 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030483|NCT01206816|EG002|Reported Event|Volasertib 300 mg+Afatinib 30 mg (Schedule A)|"Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030484|NCT01206816|EG003|Reported Event|Volasertib 300 mg+Afatinib 40 mg (Schedule A)|"Schedule A : Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21.~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030485|NCT01206816|EG004|Reported Event|Volasertib 300 mg+Afatinib 50 mg (Schedule B)|"Schedule B : Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030486|NCT01206816|EG005|Reported Event|Volasertib 300 mg+Afatinib 70 mg (Schedule B)|"Schedule B : Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030487|NCT01206816|EG006|Reported Event|Volasertib 300 mg+Afatinib 90 mg (Schedule B)|"Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21).~Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion."
11030488|NCT01207219|BG000|Baseline|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
11030489|NCT01207219|BG001|Baseline|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
11030490|NCT01207219|BG002|Baseline|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
11030491|NCT01207219|BG003|Baseline|Total|Total of all reporting groups
11030492|NCT01207219|FG000|Participant Flow|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
11030493|NCT01207219|FG001|Participant Flow|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
11030494|NCT01207219|FG002|Participant Flow|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
11030495|NCT01207219|OG000|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
11030496|NCT01207219|OG001|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
11030497|NCT01207219|OG002|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
11030498|NCT01207219|EG000|Reported Event|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
11030499|NCT01207219|EG001|Reported Event|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
11030500|NCT01207219|EG002|Reported Event|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
11030501|NCT01207388|BG000|Baseline|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
11030502|NCT01207388|FG000|Participant Flow|Blinatumomab|"Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.~Participants suitable for allogeneic hematopoietic stem cell transplant (HSCT) after treatment with at least 1 cycle of blinatumomab may have undergone allogeneic HSCT instead of receiving further cycles with blinatumomab."
11030503|NCT01207388|OG000|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
11030504|NCT01207388|OG000|Outcome|Cycle 1 MRD 10^-5|Participants with an MRD level 10^-5 at the end of cycle 1.
11030505|NCT01207388|OG001|Outcome|Cycle 1 MRD 10^-4|Participants with an MRD level 10^-4 at the end of cycle 1.
11030506|NCT01207388|OG002|Outcome|Cycle 1 MRD 10^-3|Participants with an MRD level 10^-3 at the end of cycle 1.
11030507|NCT01207388|OG003|Outcome|Cycle 1 MRD 10^-2|Participants with an MRD level 10^-2 at the end of cycle 1.
11030508|NCT01207388|OG004|Outcome|Cycle 1 MRD 10^-1|Participants with an MRD level 10^-1 at the end of cycle 1.
11030509|NCT01207388|OG005|Outcome|Cycle 1 MRD Unknown|Participants with an unknown MRD level at the end of cycle 1.
11030510|NCT01207388|OG000|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
11030511|NCT01207388|OG001|Outcome|Change From Baseline at End of Core Study|
11030512|NCT01207388|EG000|Reported Event|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
11030513|NCT01207401|BG000|Baseline|Paracervical Block|
11030514|NCT01207401|BG001|Baseline|No Paracervical Block|
11030515|NCT01207401|BG002|Baseline|Total|Total of all reporting groups
11030516|NCT01207401|FG000|Participant Flow|Paracervical Block|IUD insertion after a 10 cc 1% Lidocaine administeration at 4 o'clock and 8 o'clock at the cervical-vaginal mucosa.
11030517|NCT01207401|FG001|Participant Flow|No Paracervical Block|IUD insertion with no lidocaine injection
11030518|NCT01207401|OG000|Outcome|Paracervical Block|
11030519|NCT01207401|OG001|Outcome|No Paracervical Block|
11030520|NCT01207401|EG000|Reported Event|Paracervical Block|
11030521|NCT01207401|EG001|Reported Event|No Paracervical Block|
11030522|NCT01207414|BG000|Baseline|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
11030523|NCT01207414|BG001|Baseline|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
11030524|NCT01207414|BG002|Baseline|Total|Total of all reporting groups
11030525|NCT01207414|FG000|Participant Flow|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
11030526|NCT01207414|FG001|Participant Flow|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
11030527|NCT01207414|OG000|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
11030528|NCT01207414|OG001|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
11030529|NCT01207414|EG000|Reported Event|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
11030530|NCT01207414|EG001|Reported Event|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
11030531|NCT01207427|BG000|Baseline|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1 mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
11030532|NCT01207427|BG001|Baseline|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
11030533|NCT01207427|BG002|Baseline|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
11030534|NCT01207427|BG003|Baseline|Total|Total of all reporting groups
11030535|NCT01207427|FG000|Participant Flow|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
11030536|NCT01207427|FG001|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
11030537|NCT01207427|FG002|Participant Flow|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
10849767|NCT00298155|BG002|Baseline|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
11030538|NCT01207427|OG000|Outcome|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
11030539|NCT01207427|OG001|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
11030540|NCT01207427|OG002|Outcome|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
11030541|NCT01207427|EG000|Reported Event|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1- mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
11030542|NCT01207427|EG001|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
11030543|NCT01207427|EG002|Reported Event|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
11030544|NCT01207440|BG000|Baseline|Cohort A: CP-CML R-I|CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030545|NCT01207440|BG001|Baseline|Cohort B: CP-CML With T315I Mutation|CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030546|NCT01207440|BG002|Baseline|Cohort C: AP-CML R-I|AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
10849768|NCT00298155|BG003|Baseline|Total|Total of all reporting groups
11030547|NCT01207440|BG003|Baseline|Cohort D: AP-CML With T315I Mutation|AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030548|NCT01207440|BG004|Baseline|Cohort E: BP-CML/Ph+ ALL R-I|BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030549|NCT01207440|BG005|Baseline|Cohort F: BP-CML or Ph+ ALL With T315I Mutation|BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030550|NCT01207440|BG006|Baseline|Unassigned to Cohorts A-F|Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030551|NCT01207440|BG007|Baseline|Total|Total of all reporting groups
11030552|NCT01207440|FG000|Participant Flow|Cohort A: CP-CML R-I|CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030553|NCT01207440|FG001|Participant Flow|Cohort B: CP-CML With T315I Mutation|CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030554|NCT01207440|FG002|Participant Flow|Cohort C: AP-CML R-I|AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030555|NCT01207440|FG003|Participant Flow|Cohort D: AP-CML With T315I Mutation|AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030556|NCT01207440|FG004|Participant Flow|Cohort E: BP-CML/Ph+ ALL R-I|BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030557|NCT01207440|FG005|Participant Flow|Cohort F: BP-CML or Ph+ ALL With T315I Mutation|BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030558|NCT01207440|FG006|Participant Flow|Unassigned to Cohorts A-F|Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030559|NCT01207440|OG000|Outcome|Cohort A: CP-CML R-I|CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030560|NCT01207440|OG001|Outcome|Cohort B: CP-CML With T315I Mutation|CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030561|NCT01207440|OG000|Outcome|Cohort C: AP-CML R-I|AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030562|NCT01207440|OG001|Outcome|Cohort D: AP-CML With T315I Mutation|AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030563|NCT01207440|OG000|Outcome|Cohort E: BP-CML/Ph+ ALL R-I|BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030564|NCT01207440|OG001|Outcome|Cohort F: BP-CML or Ph+ ALL With T315I Mutation|BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030565|NCT01207440|OG002|Outcome|Cohort E: BP-CML/Ph+ ALL R-I|BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030566|NCT01207440|OG003|Outcome|Cohort F: BP-CML or Ph+ ALL With T315I Mutation|BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030567|NCT01207440|OG002|Outcome|Cohort C: AP-CML R-I|AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030568|NCT01207440|OG003|Outcome|Cohort D: AP-CML With T315I Mutation|AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030569|NCT01207440|OG004|Outcome|Cohort E: BP-CML/Ph+ ALL R-I|BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030570|NCT01207440|OG005|Outcome|Cohort F: BP-CML or Ph+ ALL With T315I Mutation|BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030571|NCT01207440|OG006|Outcome|Unassigned to Cohorts A-F|Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030572|NCT01207440|EG000|Reported Event|Cohort A: CP-CML R-I|CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030573|NCT01207440|EG001|Reported Event|Cohort B: CP-CML With T315I Mutation|CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030574|NCT01207440|EG002|Reported Event|Cohort C: AP-CML R-I|AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030575|NCT01207440|EG003|Reported Event|Cohort D: AP-CML With T315I Mutation|AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030576|NCT01207440|EG004|Reported Event|Cohort E: BP-CML/Ph+ ALL R-I|BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030577|NCT01207440|EG005|Reported Event|Cohort F: BP-CML or Ph+ ALL With T315I Mutation|BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030578|NCT01207440|EG006|Reported Event|Unassigned AP/CP-CML|Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not R-I to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
11030579|NCT01207453|BG000|Baseline|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
11030580|NCT01207453|BG001|Baseline|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
11030581|NCT01207453|BG002|Baseline|Total|Total of all reporting groups
11030582|NCT01207453|FG000|Participant Flow|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
11030583|NCT01207453|FG001|Participant Flow|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
11030584|NCT01207453|OG000|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
11030585|NCT01207453|OG001|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
11030586|NCT01207453|OG001|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Participants who take Milnacipran twice a day orally dosage was titrated up to target dosage of 50 mg (12.5 mg, 25 mg and 50 mg)."
11030587|NCT01207453|OG001|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
11030588|NCT01207453|EG000|Reported Event|Milnacipran|Participants received milnacipran for 6 weeks. The dose was titrated according to the following schedule: 1) Days 1-3: milnacipran 12.5 mg twice daily, 2) Days 4-6: milnacipran 25 mg twice daily, 3) Days 7-42: milnacipran 50 mg twice daily. If participants could not tolerate the full dose, the dose was decreased to the highest tolerated dose.
11030589|NCT01207453|EG001|Reported Event|Placebo|Participants received placebo tablets for 6 weeks. The tablets were identical in appearance to the milnacipran tablets.
11030590|NCT01207453|EG002|Reported Event|Washout Period|This 3-week period occurred after the first 6 weeks (when participants either received milnacipran or placebo). During the washout period, participants down titrated from the full dosage of milnacipran/placebo to nothing.
11030591|NCT01207466|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
11030592|NCT01207466|FG000|Participant Flow|Nelfilcon A Invest'l / nelfilconA Comm'l|Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
11030593|NCT01207466|FG001|Participant Flow|Nelfilcon A Comm'l / nelfilconA Invest'l|Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
11030594|NCT01207466|OG000|Outcome|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
11030595|NCT01207466|OG001|Outcome|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
11030596|NCT01207466|EG000|Reported Event|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
11030597|NCT01207466|EG001|Reported Event|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
11030598|NCT01207570|BG000|Baseline|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
11030599|NCT01207570|BG001|Baseline|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
11030600|NCT01207570|BG002|Baseline|Total|Total of all reporting groups
11030601|NCT01207570|FG000|Participant Flow|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
11030602|NCT01207570|FG001|Participant Flow|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
11030603|NCT01207570|OG000|Outcome|Endermotherapy|A single endermotherapy treatment session
11030604|NCT01207570|OG001|Outcome|Passive Stretching|A single passive stretching session
11030605|NCT01207570|OG000|Outcome|Endermotherapy|A single session of endermotherapy treatment
11030606|NCT01207570|OG001|Outcome|Passive Stretching|A single session of passive stretching
11030607|NCT01207570|EG000|Reported Event|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
11030608|NCT01207570|EG001|Reported Event|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
11030609|NCT01207583|BG000|Baseline|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 vaccine as standard care as per the SmPC.
11030610|NCT01207583|BG001|Baseline|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
11030611|NCT01207583|BG002|Baseline|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
11030612|NCT01207583|BG003|Baseline|Total|Total of all reporting groups
11030613|NCT01207583|FG000|Participant Flow|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of 7-valent pneumococcal conjugate vaccine (PCV7) as standard care as per the Summary of Product Characteristics (SmPC).
11030614|NCT01207583|FG001|Participant Flow|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
11030615|NCT01207583|FG002|Participant Flow|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
11030616|NCT01207583|OG000|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
11030617|NCT01207583|OG001|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
11030618|NCT01207583|OG002|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
11030619|NCT01207583|OG000|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
11030620|NCT01207583|OG001|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
11030621|NCT01207583|OG002|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
11030622|NCT01207583|OG000|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
11030623|NCT01207583|OG001|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
11030624|NCT01207583|OG000|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
11030625|NCT01207583|OG002|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccines as standard care as per the SmPC.
11030626|NCT01207583|EG000|Reported Event|Dose 1 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
11030627|NCT01207583|EG001|Reported Event|Dose 2 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
11030628|NCT01207583|EG002|Reported Event|Dose 3 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
11030629|NCT01207583|EG003|Reported Event|Dose 4 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
11030630|NCT01207583|EG004|Reported Event|Dose 1 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
11030631|NCT01207583|EG005|Reported Event|Dose 2 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
11030632|NCT01207583|EG006|Reported Event|Dose 3 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
11030633|NCT01207583|EG007|Reported Event|Dose 1 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
11030634|NCT01207583|EG008|Reported Event|Dose 2 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
11030635|NCT01207596|BG000|Baseline|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
11030636|NCT01207596|FG000|Participant Flow|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
11030637|NCT01207596|OG000|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
11030638|NCT01207596|EG000|Reported Event|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
11030639|NCT01207648|BG000|Baseline|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
11030640|NCT01207648|FG000|Participant Flow|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
11030641|NCT01207648|OG000|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
11030642|NCT01207648|EG000|Reported Event|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
11030643|NCT01207687|BG000|Baseline|Treatment (Bevacizumab)|People with NF2, not eligible for surgery with progressive vestibular schwannoma
11030644|NCT01207687|FG000|Participant Flow|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
11030645|NCT01207687|OG000|Outcome|Treatment (Bevacizumab) - All Participants|Patients who met all eligibility criteria underwent baseline evaluation and then received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity. Hearing evaluation for word recognition score was evaluated every 12 weeks. Hearing response was defined as improvement beyond the 95% CI maintained across 2 timepoints.
11030646|NCT01207687|OG001|Outcome|Treatment (Bevacizumab) - Pediatric Participants Only|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
11030647|NCT01207687|OG000|Outcome|Treatment (Bevacizumab) - All Participants|All enrolled patients received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
11030648|NCT01207687|OG001|Outcome|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
11030649|NCT01207687|OG000|Outcome|Treatment (Bevacizumab) - All Participants|All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
11030650|NCT01207687|OG000|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
11030651|NCT01207687|EG000|Reported Event|Treatment (Bevacizumab) - All Participants|All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
11030652|NCT01207687|EG001|Reported Event|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
11030653|NCT01207752|BG000|Baseline|Systane Balance|"Artificial tear emulsion~Systane Balance: Artificial tear emulsion drop"
11030654|NCT01207752|BG001|Baseline|Optive Lubricant Eye Drops|"Artificial tear~Optive Lubricant Eye Drops: Artificial tear eye drop"
11030655|NCT01207752|BG002|Baseline|Total|Total of all reporting groups
11030656|NCT01207752|FG000|Participant Flow|Systane Balance|"Artificial tear emulsion~Systane Balance: Artificial tear emulsion drop"
11030657|NCT01207752|FG001|Participant Flow|Optive Lubricant Eye Drops|"Artificial tear~Optive Lubricant Eye Drops: Artificial tear eye drop"
11030658|NCT01207752|OG000|Outcome|Systane Balance|"Artificial tear emulsion~Systane Balance: Artificial tear emulsion drop"
11030659|NCT01207752|OG001|Outcome|Optive Lubricant Eye Drops|"Artificial tear~Optive Lubricant Eye Drops: Artificial tear eye drop"
11030660|NCT01207752|EG000|Reported Event|Systane Balance|"Artificial tear emulsion~Systane Balance: Artificial tear emulsion drop"
11030661|NCT01207752|EG001|Reported Event|Optive Lubricant Eye Drops|"Artificial tear~Optive Lubricant Eye Drops: Artificial tear eye drop"
11030662|NCT01207765|BG000|Baseline|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
11030663|NCT01207765|FG000|Participant Flow|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
11030664|NCT01207765|OG000|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
11030665|NCT01207765|EG000|Reported Event|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
11030666|NCT01207908|BG000|Baseline|IGF-1|"IGF-1 plus standard steroid treatment~IGF-1: IGF-1 will be administered once daily by subcutaneous injection every morning with breakfast. Duration 6 months."
11030667|NCT01207908|BG001|Baseline|Standard Steroid Treatment Alone|Standard daily steroid treatment for DMD
11030668|NCT01207908|BG002|Baseline|Total|Total of all reporting groups
11030669|NCT01207908|FG000|Participant Flow|IGF-1|"IGF-1 plus standard steroid treatment~IGF-1: IGF-1 will be administered once daily by subcutaneous injection every morning with breakfast. Duration 6 months."
11030670|NCT01207908|FG001|Participant Flow|Standard Steroid Treatment Alone|Once daily steroid treatment (Deflazacort or Prednisone) administered orally for DMD.
11030671|NCT01207908|OG000|Outcome|IGF-1|"IGF-1 plus standard steroid treatment~IGF-1: IGF-1 will be administered once daily by subcutaneous injection every morning with breakfast. Duration 6 months."
11030672|NCT01207908|OG001|Outcome|Standard Steroid Treatment Alone|Once daily steroid treatment (Deflazacort or Prednisone) administered orally for DMD.
11030673|NCT01207908|EG000|Reported Event|IGF-1|"IGF-1 plus standard steroid treatment~IGF-1: IGF-1 will be administered once daily by subcutaneous injection every morning with breakfast. Duration 6 months."
11030674|NCT01207908|EG001|Reported Event|Standard Steroid Treatment Alone|Standard daily steroid treatment for DMD
11030675|NCT01207934|BG000|Baseline|Placebo|saline placebo for fourteen days
11030676|NCT01207934|BG001|Baseline|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
11030677|NCT01207934|BG002|Baseline|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
11030678|NCT01207934|BG003|Baseline|Total|Total of all reporting groups
11030679|NCT01207934|FG000|Participant Flow|Placebo|saline placebo for fourteen days
11030680|NCT01207934|FG001|Participant Flow|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
11030681|NCT01207934|FG002|Participant Flow|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
11030682|NCT01207934|OG000|Outcome|Placebo|14 days on placebo (saline)
11030683|NCT01207934|OG001|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
11030684|NCT01207934|OG002|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
11030685|NCT01207934|EG000|Reported Event|Placebo|saline placebo for fourteen days
11030686|NCT01207934|EG001|Reported Event|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
11030687|NCT01207934|EG002|Reported Event|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
11030688|NCT01208038|BG000|Baseline|Testosterone|"Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks~Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks"
11030689|NCT01208038|FG000|Participant Flow|Testosterone|"Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks~Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks"
11030690|NCT01208038|OG000|Outcome|Testosterone|"Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks~Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks"
11030691|NCT01208038|EG000|Reported Event|Testosterone|"Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks~Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks"
11030692|NCT01208051|BG000|Baseline|Phase I Dose Level 0|Cediranib 20 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 15 days of a 28 day cycle)
11030693|NCT01208051|BG001|Baseline|Phase I Dose Level +1|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 21 days of a 28 day cycle)
11030694|NCT01208051|BG002|Baseline|Phase I Dose Level +2|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (28/28 days, i.e., given for 28 days of a 28 day cycle)
11030695|NCT01208051|BG003|Baseline|Phase II Arm A (Cediranib Maleate)|"Patients receive cediranib maleate 30 mg PO QD on days 1-28. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11030696|NCT01208051|BG004|Baseline|Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)|"Patients receive cediranib maleate 30 mg PO and lenalidomide 15 mg PO on days 1-21. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. NOTE: As of April 10, 2015, patients assigned to this arm are discontinued lenalidomide and continued on cediranib alone.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11030697|NCT01208051|BG005|Baseline|Total|Total of all reporting groups
11030698|NCT01208051|FG000|Participant Flow|Phase I Dose Level 0|Cediranib 20 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 15 days of a 28 day cycle)
11030699|NCT01208051|FG001|Participant Flow|Phase I Dose Level +1|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 21 days of a 28 day cycle)
11030700|NCT01208051|FG002|Participant Flow|Phase I Dose Level +2|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (28/28 days, i.e., given for 28 days of a 28 day cycle)
11030701|NCT01208051|FG003|Participant Flow|Phase II Arm A (Cediranib Maleate)|"Patients receive cediranib maleate 30 mg PO QD on days 1-28. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11030702|NCT01208051|FG004|Participant Flow|Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)|"Patients receive cediranib maleate 30 mg PO and lenalidomide 15 mg PO on days 1-21. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. NOTE: As of April 10, 2015, patients assigned to this arm are discontinued lenalidomide and continued on cediranib alone.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11030703|NCT01208051|OG000|Outcome|Phase I Dose Level 0|Cediranib 20 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 15 days of a 28 day cycle)
11030704|NCT01208051|OG001|Outcome|Phase I Dose Level +1|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 21 days of a 28 day cycle)
11030705|NCT01208051|OG002|Outcome|Phase I Dose Level +2|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (28/28 days, i.e., given for 28 days of a 28 day cycle)
11030706|NCT01208051|OG003|Outcome|Phase II Arm A (Cediranib Maleate)|"Patients receive cediranib maleate 30 mg PO QD on days 1-28. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11030707|NCT01208051|OG004|Outcome|Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)|"Patients receive cediranib maleate 30 mg PO and lenalidomide 15 mg PO on days 1-21. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. NOTE: As of April 10, 2015, patients assigned to this arm are discontinued lenalidomide and continued on cediranib alone.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11030708|NCT01208051|OG000|Outcome|Dose Level 0|Cediranib 20 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 15 days of a 28 day cycle)
11030709|NCT01208051|OG001|Outcome|Dose Level +1|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 21 days of a 28 day cycle)
11030710|NCT01208051|OG002|Outcome|Dose Level +2|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (28/28 days, i.e., given for 28 days of a 28 day cycle)
11030711|NCT01208051|OG004|Outcome|Phase II Arm B (Cediranib Maleate Plus Lenalidomide)|"Patients receive cediranib maleate 30 mg PO and lenalidomide 15 mg PO on days 1-21. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. NOTE: As of April 10, 2015, patients assigned to this arm are discontinued lenalidomide and continued on cediranib alone.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11030712|NCT01208051|EG000|Reported Event|Phase I Dose Level 0|Cediranib 20 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 15 days of a 28 day cycle)
11030713|NCT01208051|EG001|Reported Event|Phase I Dose Level +1|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (21/28 days, i.e., given for 21 days of a 28 day cycle)
11030714|NCT01208051|EG002|Reported Event|Phase I Dose Level +2|Cediranib 30 mg (28/28 days, i.e., given for 28 days of a 28 day cycle) + Lenalidomide 15 mg (28/28 days, i.e., given for 28 days of a 28 day cycle)
11030715|NCT01208051|EG003|Reported Event|Phase II Arm A (Cediranib Maleate)|"Patients receive cediranib maleate 30 mg PO QD on days 1-28. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11030716|NCT01208051|EG004|Reported Event|Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)|"Patients receive cediranib maleate 30 mg PO and lenalidomide 15 mg PO on days 1-21. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. NOTE: As of April 10, 2015, patients assigned to this arm are discontinued lenalidomide and continued on cediranib alone.~Cediranib: Given PO~Cediranib Maleate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11030717|NCT01208103|BG000|Baseline|Bevacizumab + Capecitabine + Oxaliplatin|Capecitabine 750 mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11030718|NCT01208103|FG000|Participant Flow|Bevacizumab + Capecitabine + Oxaliplatin|Capecitabine 750 mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11030719|NCT01208103|OG000|Outcome|Bevacizumab + Capecitabine + Oxaliplatin|Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11030720|NCT01208103|OG000|Outcome|Bevacizumab + Capecitabine + Oxaliplatin|Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11030721|NCT01208103|EG000|Reported Event|Bevacizumab + Capecitabine + Oxaliplatin|Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
11030722|NCT01208220|BG000|Baseline|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
11030723|NCT01208220|BG001|Baseline|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
11030724|NCT01208220|BG002|Baseline|Total|Total of all reporting groups
11030725|NCT01208220|FG000|Participant Flow|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
11030726|NCT01208220|FG001|Participant Flow|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
11030727|NCT01208220|OG000|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
11030728|NCT01208220|OG001|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
11030729|NCT01208220|EG000|Reported Event|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
11030730|NCT01208220|EG001|Reported Event|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
11030731|NCT01208233|BG000|Baseline|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
11030732|NCT01208233|BG001|Baseline|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
11030733|NCT01208233|BG002|Baseline|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
11030734|NCT01208233|BG003|Baseline|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
11030735|NCT01208233|BG004|Baseline|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
11030736|NCT01208233|BG005|Baseline|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
11030737|NCT01208233|BG006|Baseline|Total|Total of all reporting groups
11030738|NCT01208233|FG000|Participant Flow|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
11030739|NCT01208233|FG001|Participant Flow|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
11030740|NCT01208233|FG002|Participant Flow|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
11030741|NCT01208233|FG003|Participant Flow|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
11030742|NCT01208233|FG004|Participant Flow|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
11030743|NCT01208233|FG005|Participant Flow|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
11030744|NCT01208233|OG000|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
11030745|NCT01208233|OG001|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
11030746|NCT01208233|OG002|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
11030747|NCT01208233|OG003|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
11030748|NCT01208233|OG004|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
11030749|NCT01208233|OG005|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
11030750|NCT01208233|OG000|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
11030751|NCT01208233|OG001|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
11030752|NCT01208233|OG001|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
11030753|NCT01208233|OG002|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
11030754|NCT01208233|OG003|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
11030755|NCT01208233|OG005|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
11030756|NCT01208233|EG000|Reported Event|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
11030757|NCT01208233|EG001|Reported Event|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
11030758|NCT01208233|EG002|Reported Event|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
11030759|NCT01208233|EG003|Reported Event|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
11030760|NCT01208233|EG004|Reported Event|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
11030761|NCT01208233|EG005|Reported Event|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
11066425|NCT01392378|BG000|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
11030762|NCT01208324|BG000|Baseline|Active Patch: Active Tryptophan, Then Sham Tryptophan|Participants assigned to receive the Active ET patch, and sequence of active tryptophan followed by sham tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030763|NCT01208324|BG001|Baseline|Active Patch: Sham Tryptophan, Then Active Tryptophan|Participants assigned to receive the Active ET patch, and sequence of sham tryptophan followed by active tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030764|NCT01208324|BG002|Baseline|Sham Patch: Active Tryptophan, Then Sham Tryptophan|Participants assigned to receive the Sham patch, and sequence of active tryptophan followed by sham tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030765|NCT01208324|BG003|Baseline|Sham Patch: Sham Tryptophan, Then Active Tryptophan|Participants assigned to receive the Sham ET patch, and sequence of sham tryptophan followed by active tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030766|NCT01208324|BG004|Baseline|Total|Total of all reporting groups
11030767|NCT01208324|FG000|Participant Flow|Active Patch: Active Tryptophan, Then Sham Tryptophan|Participants assigned to receive the Active ET patch, and sequence of active tryptophan followed by sham tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030768|NCT01208324|FG001|Participant Flow|Active Patch: Sham Tryptophan, Then Active Tryptophan|Participants assigned to receive the Active ET patch, and sequence of sham tryptophan followed by active tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030769|NCT01208324|FG002|Participant Flow|Sham Patch: Active Tryptophan, Then Sham Tryptophan|Participants assigned to receive the Sham patch, and sequence of active tryptophan followed by sham tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030770|NCT01208324|FG003|Participant Flow|Sham Patch: Sham Tryptophan, Then Active Tryptophan|Participants assigned to receive the Sham ET patch, and sequence of sham tryptophan followed by active tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030771|NCT01208324|OG000|Outcome|High Ace|Participants with an adverse childhood experience (ACE) score greater than or equal to 2.
11030772|NCT01208324|OG001|Outcome|Low Ace|Participants with an adverse childhood experience (ACE) score less than 2.
11030773|NCT01208324|OG000|Outcome|High ACE|Participants with an adverse childhood experience (ACE) score greater than or equal to 2.
11030774|NCT01208324|OG001|Outcome|Low ACE|Participants with an adverse childhood experience (ACE) score less than 2.
11030775|NCT01208324|EG000|Reported Event|Active Patch: Active Tryptophan, Then Sham Tryptophan|Participants assigned to receive the Active ET patch, and sequence of active tryptophan followed by sham tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030776|NCT01208324|EG001|Reported Event|Active Patch: Sham Tryptophan, Then Active Tryptophan|Participants assigned to receive the Active ET patch, and sequence of sham tryptophan followed by active tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030777|NCT01208324|EG002|Reported Event|Sham Patch: Active Tryptophan, Then Sham Tryptophan|Participants assigned to receive the Sham patch, and sequence of active tryptophan followed by sham tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030778|NCT01208324|EG003|Reported Event|Sham Patch: Sham Tryptophan, Then Active Tryptophan|Participants assigned to receive the Sham ET patch, and sequence of sham tryptophan followed by active tryptophan. There will be four successful* TRP depletion test sequences: two test sequences one week apart prior to randomization to ET or PT, and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. Each TRP depletion test day will involve ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion; for participants who are not lactose intolerant) or 31.5 g of microcellulose (sham depletion; for participants who have mild to moderate lactose intolerance), while during the other test they will contain a total of 31.5 g of amino acids, but no tryptophan.
11030779|NCT01208337|BG000|Baseline|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
11030780|NCT01208337|FG000|Participant Flow|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
11030781|NCT01208337|OG000|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
11030782|NCT01208337|EG000|Reported Event|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
11030783|NCT01208402|BG000|Baseline|Long-Acting Beta Blocker|Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
11030784|NCT01208402|BG001|Baseline|Esmolol|Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
11030785|NCT01208402|BG002|Baseline|Total|Total of all reporting groups
11030786|NCT01208402|FG000|Participant Flow|Long-Acting Beta Blocker|Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
11030787|NCT01208402|FG001|Participant Flow|Esmolol|Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
11030788|NCT01208402|OG000|Outcome|Long-Acting Beta Blocker|Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
11030789|NCT01208402|OG001|Outcome|Esmolol|Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
11030790|NCT01208402|EG000|Reported Event|Long-Acting Beta Blocker|Administer patient's routine oral long acting beta blocker on day of surgery (standard of care).
11030791|NCT01208402|EG001|Reported Event|Esmolol|Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
11030792|NCT01208415|BG000|Baseline|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
11030793|NCT01208415|FG000|Participant Flow|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
11030794|NCT01208415|OG000|Outcome|Device Implant|Endovascular repair for aortoiliac or iliac aneurysms.: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.
11030795|NCT01208415|EG000|Reported Event|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
11030796|NCT01208870|BG000|Baseline|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030797|NCT01208870|BG001|Baseline|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030798|NCT01208870|BG002|Baseline|Total|Total of all reporting groups
11030799|NCT01208870|FG000|Participant Flow|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group. Experimental"
11030800|NCT01208870|FG001|Participant Flow|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030801|NCT01208870|OG000|Outcome|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030802|NCT01208870|OG001|Outcome|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030803|NCT01208870|OG000|Outcome|Experimental Group|"Traditional family based weight control treatment program with components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 sessions.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030804|NCT01208870|OG001|Outcome|Nutrition Education Control|"Traditional family based weight control treatment program, without components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 sessions.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030805|NCT01208870|EG000|Reported Event|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030806|NCT01208870|EG001|Reported Event|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
11030807|NCT01208922|BG000|Baseline|Group A|"Rifamycin SV-MMX® 200 mg tablets~Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d."
11030808|NCT01208922|BG001|Baseline|Group B|"Ciprofloxacin 500 mg capsules~Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d."
11030809|NCT01208922|BG002|Baseline|Total|Total of all reporting groups
11030810|NCT01208922|FG000|Participant Flow|Rifamycin Group|"Rifamycin SV-MMX® 200 mg tablets~Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d."
11030811|NCT01208922|FG001|Participant Flow|Ciprofloxacin Group|"Ciprofloxacin 500 mg capsules~Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d."
11030812|NCT01208922|OG000|Outcome|Group A|"Rifamycin SV-MMX® 200 mg tablets~Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d."
11030813|NCT01208922|OG001|Outcome|Group B|"Ciprofloxacin 500 mg capsules~Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d."
11030814|NCT01208922|EG000|Reported Event|Group A|"Rifamycin SV-MMX® 200 mg tablets~Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d."
11030815|NCT01208922|EG001|Reported Event|Group B|"Ciprofloxacin 500 mg capsules~Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d."
11030816|NCT01208961|BG000|Baseline|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
11030817|NCT01208961|FG000|Participant Flow|Epanova-Lovaza-Epanova-Lovaza|Epanova (4 g) and Lovaza (4 g) : Single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
11030818|NCT01208961|FG001|Participant Flow|Lovaza-Epanova-Lovaza-Epanova|Lovaza (4 g) and Epanova (4 g) : Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Epanova (omefas),4x1g capsules, taken with high-fat meals
11030819|NCT01208961|OG000|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
11030820|NCT01208961|OG001|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
11030821|NCT01208961|EG000|Reported Event|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
11030822|NCT01209078|BG000|Baseline|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030823|NCT01209078|BG001|Baseline|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030824|NCT01209078|BG002|Baseline|Total|Total of all reporting groups
11030825|NCT01209078|FG000|Participant Flow|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 milliliter (mL) of water or liquid.
11030826|NCT01209078|FG001|Participant Flow|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030827|NCT01209078|OG000|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030828|NCT01209078|OG001|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030829|NCT01209078|OG000|Outcome|GSK1322322 1500 mg|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030830|NCT01209078|OG001|Outcome|Linezolid 600 mg|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030831|NCT01209078|EG000|Reported Event|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030832|NCT01209078|EG001|Reported Event|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
11030833|NCT01209143|BG000|Baseline|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
11030834|NCT01209143|BG001|Baseline|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
11030835|NCT01209143|BG002|Baseline|Total|Total of all reporting groups
11030836|NCT01209143|FG000|Participant Flow|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
11030837|NCT01209143|FG001|Participant Flow|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
11030838|NCT01209143|OG000|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
11030839|NCT01209143|OG000|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
11030840|NCT01209143|EG000|Reported Event|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
11030841|NCT01209143|EG001|Reported Event|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
11030842|NCT01209195|BG000|Baseline|MM-121 + Paclitaxel: Dose Escalation|"MM-121 plus Paclitaxel: Cohort 1:~MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Intermediate doses between cohorts 1 and 2 may also be considered."
11030843|NCT01209195|BG001|Baseline|MM-121 + Paclitaxel: Expansion Cohort|MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
11030844|NCT01209195|BG002|Baseline|Total|Total of all reporting groups
11030845|NCT01209195|FG000|Participant Flow|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
11030846|NCT01209195|FG001|Participant Flow|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
11030847|NCT01209195|FG002|Participant Flow|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
11030848|NCT01209195|FG003|Participant Flow|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
11030849|NCT01209195|FG004|Participant Flow|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
11030850|NCT01209195|FG005|Participant Flow|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
11030851|NCT01209195|OG000|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
11030852|NCT01209195|OG001|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
11030853|NCT01209195|OG002|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
11030854|NCT01209195|OG003|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
11030855|NCT01209195|OG004|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
11030856|NCT01209195|OG005|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
11030857|NCT01209195|OG000|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
11030858|NCT01209195|OG001|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
11030859|NCT01209195|OG000|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
11030860|NCT01209195|OG001|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
11030861|NCT01209195|OG002|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
11030862|NCT01209195|OG003|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.~Paclitaxel: 80 mg/m2"
11030863|NCT01209195|EG000|Reported Event|MM-121 + Paclitaxel: Dose Escalation|"Cohort 1:~MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV"
11030864|NCT01209195|EG001|Reported Event|MM-121 + Paclitaxel: Expansion Cohort|"Cohort 1:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 20 mg/kg IV loading dose x followed by 12 mg/kg IV QW maintenance dose Paclitaxel: 80 mg/m2 weekly IV~Cohort 3:~MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV~Cohort 4:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
11030865|NCT01209234|BG000|Baseline|MRSA Decolonization|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.~MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month."
11030866|NCT01209234|BG001|Baseline|Education Arm|"Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.~Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home."
11030867|NCT01209234|BG002|Baseline|Total|Total of all reporting groups
11030868|NCT01209234|FG000|Participant Flow|MRSA Decolonization|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.~MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month."
11030869|NCT01209234|FG001|Participant Flow|Education Arm|"Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.~Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home."
11030870|NCT01209234|OG000|Outcome|MRSA Decolonization|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.~MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month."
11030871|NCT01209234|OG001|Outcome|Education Arm|"Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.~Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home."
11030872|NCT01209234|EG000|Reported Event|MRSA Decolonization|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.~MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month."
11030873|NCT01209234|EG001|Reported Event|Education Arm|"Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.~Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home."
11030874|NCT01209260|BG000|Baseline|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
11030875|NCT01209260|BG001|Baseline|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
11030876|NCT01209260|BG002|Baseline|Total|Total of all reporting groups
11030877|NCT01209260|FG000|Participant Flow|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
11030878|NCT01209260|FG001|Participant Flow|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
11030879|NCT01209260|OG000|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
11030880|NCT01209260|OG001|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
11030881|NCT01209260|OG000|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
11030882|NCT01209260|OG001|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
11030883|NCT01209260|EG000|Reported Event|Radiofrequency Energy Needle (RF)|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
11030884|NCT01209260|EG001|Reported Event|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
11030885|NCT01209286|BG000|Baseline|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
11030886|NCT01209286|BG001|Baseline|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
11030887|NCT01209286|BG002|Baseline|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
11030888|NCT01209286|BG003|Baseline|Total|Total of all reporting groups
11030889|NCT01209286|FG000|Participant Flow|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
11030890|NCT01209286|FG001|Participant Flow|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
11030891|NCT01209286|FG002|Participant Flow|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
11030892|NCT01209286|OG000|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
11030893|NCT01209286|OG001|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
11030894|NCT01209286|OG002|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
11030895|NCT01209286|OG003|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
11030896|NCT01209286|OG002|Outcome|ABlinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
11030897|NCT01209286|OG003|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
11030898|NCT01209286|OG003|Outcome|Blinatumimab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
11030899|NCT01209286|OG000|Outcome|Blinatumomab 5 μg|Participants receiving blinatumomab 5 μg/m²/day.
11030900|NCT01209286|OG001|Outcome|Blinatumomab 15 μg|Participants receiving blinatumomab 15 μg/m²/day.
10849769|NCT00298155|FG000|Participant Flow|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
11030901|NCT01209286|OG002|Outcome|Blinatumomab 30 μg|Participants receiving blinatumomab 30 μg/m²/day.
11030902|NCT01209286|OG000|Outcome|Blinatumomab|All participants who received blinatumomab.
11030903|NCT01209286|EG000|Reported Event|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
11030904|NCT01209286|EG001|Reported Event|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
11030905|NCT01209286|EG002|Reported Event|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
11030906|NCT01209286|EG003|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
11030907|NCT01209325|BG000|Baseline|Vaccination|"Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine~laboratory biomarker analysis"
11030908|NCT01209325|FG000|Participant Flow|Vaccination|"Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine~laboratory biomarker analysis"
11030909|NCT01209325|OG000|Outcome|Naive to HPV 6|HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
11030910|NCT01209325|OG001|Outcome|Prior Exposure to HPV 6|HPV 6 positive based on serum at visit 0.
11030911|NCT01209325|OG000|Outcome|Naive to HPV 11|HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
11030912|NCT01209325|OG001|Outcome|Prior Exposure to HPV 11|HPV 11 positive based on serum at visit 0.
11030913|NCT01209325|OG000|Outcome|Naive to HPV 16|HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
11030914|NCT01209325|OG001|Outcome|Prior Exposure to HPV 16|HPV 16 positive based on serum at visit 0.
11030915|NCT01209325|OG000|Outcome|Naive to HPV 18|HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
11030916|NCT01209325|OG001|Outcome|Prior Exposure to HPV 18|HPV 18 positive based on serum at visit 0.
11030917|NCT01209325|OG001|Outcome|Prior Exposure HPV 6|HPV 6 positive based on serum at visit 0 from any anatomical site.
11030918|NCT01209325|OG001|Outcome|Prior Exposure to HPV 11|HPV 11 positive based on serum at visit 0 from any anatomical site.
11030919|NCT01209325|OG001|Outcome|Prior Exposure to HPV 16|HPV 16 positive based on serum at visit 0 from any anatomical site.
11030920|NCT01209325|OG001|Outcome|Prior Exposure to HPV 18|HPV 18 positive based on serum at visit 0 from any anatomical site.
11030921|NCT01209325|OG000|Outcome|Vaccination|"Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine~laboratory biomarker analysis"
11030922|NCT01209325|OG000|Outcome|HPV 6 Sero-negative at Baseline|Sero-negative for HPV 6 at baseline.
11030923|NCT01209325|OG001|Outcome|HPV 6 Sero-positive at Baseline|Sero-positive for HPV 6 at baseline
11030924|NCT01209325|OG000|Outcome|HPV 11 Sero-negative at Baseline|Sero-negative for HPV 11 at baseline.
11030925|NCT01209325|OG001|Outcome|HPV 11 Sero-positive at Baseline|Sero-positive for HPV 11 at baseline
11030926|NCT01209325|OG000|Outcome|HPV 16 Sero-negative at Baseline|Sero-negative for HPV 16 at baseline.
11030927|NCT01209325|OG001|Outcome|HPV 16 Sero-positive at Baseline|Sero-positive for HPV 16 at baseline
11030928|NCT01209325|OG000|Outcome|HPV 18 Sero-negative at Baseline|Sero-negative for HPV 18 at baseline.
11030929|NCT01209325|OG001|Outcome|HPV 18 Sero-positive at Baseline|Sero-positive for HPV 18 at baseline
11030930|NCT01209325|OG000|Outcome|Month 7 Visit|Month 7 visit after enrollment
11030931|NCT01209325|OG001|Outcome|Month 24 Visit|Month 24 visit after enrollment
11030932|NCT01209325|EG000|Reported Event|Vaccination|"Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine~laboratory biomarker analysis"
11030933|NCT01209442|BG000|Baseline|RT With Temozolomide and Bevacizumab|Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily TMZ at 75 mg/m2 qd concurrent with IMRT (including weekends and holidays). Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Day 1 and the 1st Fx of IMRT must start on the same day. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab therapy, patients will have a brain MRI and if there is no evidence of disease progression, patients will receive 6 cycles of Bevacizumab and TMZ. Beginning a minimum of 28 days after the last radiation treatment the bevacizumab will be dosed at 10 mg/kg on day 1 and day 15 of each cycle. TMZ will be given at 150-200 mg/m2 qd on days 1-5 of each cycle. Each cycle is 28 days.
11030934|NCT01209442|FG000|Participant Flow|RT With Temozolomide and Bevacizumab|Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily TMZ at 75 mg/m2 qd concurrent with IMRT (including weekends and holidays). Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Day 1 and the 1st Fx of IMRT must start on the same day. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab therapy, patients will have a brain MRI and if there is no evidence of disease progression, patients will receive 6 cycles of Bevacizumab and TMZ. Beginning a minimum of 28 days after the last radiation treatment the bevacizumab will be dosed at 10 mg/kg on day 1 and day 15 of each cycle. TMZ will be given at 150-200 mg/m2 qd on days 1-5 of each cycle. Each cycle is 28 days.
11030935|NCT01209442|OG000|Outcome|RT With Temozolomide and Bevacizumab|Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily TMZ at 75 mg/m2 qd concurrent with IMRT (including weekends and holidays). Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Day 1 and the 1st Fx of IMRT must start on the same day. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab therapy, patients will have a brain MRI and if there is no evidence of disease progression, patients will receive 6 cycles of Bevacizumab and TMZ. Beginning a minimum of 28 days after the last radiation treatment the bevacizumab will be dosed at 10 mg/kg on day 1 and day 15 of each cycle. TMZ will be given at 150-200 mg/m2 qd on days 1-5 of each cycle. Each cycle is 28 days.
11030936|NCT01209442|EG000|Reported Event|RT With Temozolomide and Bevacizumab|Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily TMZ at 75 mg/m2 qd concurrent with IMRT (including weekends and holidays). Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Day 1 and the 1st Fx of IMRT must start on the same day. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab therapy, patients will have a brain MRI and if there is no evidence of disease progression, patients will receive 6 cycles of Bevacizumab and TMZ. Beginning a minimum of 28 days after the last radiation treatment the bevacizumab will be dosed at 10 mg/kg on day 1 and day 15 of each cycle. TMZ will be given at 150-200 mg/m2 qd on days 1-5 of each cycle. Each cycle is 28 days.
11030937|NCT01209598|BG000|Baseline|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
11030938|NCT01209598|BG001|Baseline|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients."
11030939|NCT01209598|BG002|Baseline|Total|Total of all reporting groups
11030940|NCT01209598|FG000|Participant Flow|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
11030941|NCT01209598|FG001|Participant Flow|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients."
11030942|NCT01209598|OG000|Outcome|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
11030943|NCT01209598|OG001|Outcome|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients."
11030944|NCT01209598|OG001|Outcome|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients.~Expansion Cohort: Dosed as per Schedule 3/1. Capsules should be taken with food."
11030945|NCT01209598|EG000|Reported Event|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
11030946|NCT01209598|EG001|Reported Event|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients."
11030947|NCT01209624|BG000|Baseline|Xalatan®|Once daily as 1 drop (topical application) in the evening
11030948|NCT01209624|FG000|Participant Flow|Xalatan®|Once daily as 1 drop (topical application) in the evening
11030949|NCT01209624|OG000|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
11030950|NCT01209624|EG000|Reported Event|Xalatan®|Once daily as 1 drop (topical application) in the evening
11030951|NCT01209689|BG000|Baseline|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
11030952|NCT01209689|BG001|Baseline|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
11030953|NCT01209689|BG002|Baseline|Total|Total of all reporting groups
11030954|NCT01209689|FG000|Participant Flow|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
11030955|NCT01209689|FG001|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
11030956|NCT01209689|OG000|Outcome|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
11030957|NCT01209689|OG001|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
11030958|NCT01209689|EG000|Reported Event|Tocilizumab|Patients randomized to tocilizumab who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks for 24 weeks and patients randomized to placebo who switched or escaped to tocilizumab treatment.
11030959|NCT01209689|EG001|Reported Event|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
11066426|NCT01392378|BG001|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
11066427|NCT01392378|BG002|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
11066428|NCT01392378|BG003|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
11066429|NCT01392378|BG004|Baseline|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
11066430|NCT01392378|BG005|Baseline|Total|Total of all reporting groups
11066431|NCT01392378|FG000|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
11030960|NCT01209702|BG000|Baseline|Combined Placebo|Participants in Part 1 and Part 2 who received intravenous infusions of placebo once every 4 weeks.
11030961|NCT01209702|BG001|Baseline|Combined Tocilizumab|Participants randomized in Part 1 and Part 2 to receive intravenous infusions of 4 mg/kg (in Part 2 only) or 8 mg/kg tocilizumab once every 4 weeks.
11030962|NCT01209702|BG002|Baseline|Total|Total of all reporting groups
11030963|NCT01209702|FG000|Participant Flow|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
11030964|NCT01209702|FG001|Participant Flow|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
11030965|NCT01209702|FG002|Participant Flow|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
11030966|NCT01209702|FG003|Participant Flow|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
11030967|NCT01209702|OG000|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12.
11030968|NCT01209702|OG001|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12.
11030969|NCT01209702|OG000|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
11030970|NCT01209702|OG001|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
10849770|NCT00298155|FG001|Participant Flow|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
11030971|NCT01209702|OG000|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
11030972|NCT01209702|OG001|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
11030973|NCT01209702|OG002|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
11030974|NCT01209702|OG003|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
11030975|NCT01209702|OG000|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
11030976|NCT01209702|OG001|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
11030977|NCT01209702|OG000|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
11030978|NCT01209702|OG000|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
11030979|NCT01209702|OG000|Outcome|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2, including participants randomized to placebo who switched or escaped to tocilizumab treatment.
11030980|NCT01209702|EG000|Reported Event|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
11030981|NCT01209702|EG001|Reported Event|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
11030982|NCT01209702|EG002|Reported Event|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks. AEs reported only until participants escaped or switched to tocilizumab.
11030983|NCT01209702|EG003|Reported Event|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2. This group includes participants randomized to placebo who switched or escaped to tocilizumab treatment for whom adverse events are reported after the start of treatment with tocilizumab.
11030984|NCT01209780|BG000|Baseline|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
11030985|NCT01209780|BG001|Baseline|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of vaccine.
11030986|NCT01209780|BG002|Baseline|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
11030987|NCT01209780|BG003|Baseline|Control (9-17 Years)|All subjects received one dose of control TIV (eTIV_f).
11030988|NCT01209780|BG004|Baseline|Total|Total of all reporting groups
11030989|NCT01209780|FG000|Participant Flow|TIV (3-8 Years Old)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
11030990|NCT01209780|FG001|Participant Flow|Control (4-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf.
11030991|NCT01209780|FG002|Participant Flow|Control (3 to < 4 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV.
11030992|NCT01209780|FG003|Participant Flow|TIV (9-17 Years)|All subjects in this group were non-naive and received one dose of investigational TIV.
11030993|NCT01209780|FG004|Participant Flow|Control (9-17 Years)|All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.
11030994|NCT01209780|OG000|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
11030995|NCT01209780|OG001|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
11030996|NCT01209780|OG000|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
11030997|NCT01209780|OG001|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
11030998|NCT01209780|OG002|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
11030999|NCT01209780|OG003|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine(TIVf).
11031000|NCT01209780|OG003|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine (TIVf).
11031001|NCT01209780|EG000|Reported Event|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
11031002|NCT01209780|EG001|Reported Event|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
11031003|NCT01209780|EG002|Reported Event|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
11031004|NCT01209780|EG003|Reported Event|Control (9-17 Years)|All subjects received one dose of control vaccine (TIV_f).
11031005|NCT01209832|BG000|Baseline|Midazolam + Tasisulam|"Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1.~Period 2 (28 days): Tasisulam intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms per milliliter (h*mcg/mL) on Day 1 and 1.2 mg midazolam orally on Day 8.~Maintenance Period (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h*mcg/mL on Day 1."
11031006|NCT01209832|FG000|Participant Flow|Midazolam + Tasisulam|"Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1.~Period 2 (28 days): Tasisulam intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms per milliliter (h*mcg/mL) on Day 1 and 1.2 mg midazolam orally on Day 8.~Maintenance Period 1 and 2 (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h*mcg/mL on Day 1."
11031007|NCT01209832|OG000|Outcome|Midazolam|Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1.
11031008|NCT01209832|OG001|Outcome|Midazolam + Tasisulam|Period 2 (28 days): Tasisulam was dosed intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms per milliliter (h*mcg/mL) on Day 1 and followed by 1.2 mg midazolam orally on Day 8.
11031009|NCT01209832|OG000|Outcome|Midazolam + Tasisulam|"Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1.~Period 2 (28 days): Tasisulam intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms per milliliter (h*mcg/mL) on Day 1 and 1.2 mg midazolam orally on Day 8.~Maintenance Period (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h*mcg/mL on Day 1."
11031010|NCT01209832|OG000|Outcome|Tasisulam|Period 2 (28 days): Tasisulam was dosed intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms per milliliter (h*mcg/mL) on Day 1 and followed by 1.2 milligrams (mg) midazolam orally on Day 8.
11031011|NCT01209832|OG000|Outcome|Tasisulam|Period 2 (28 days): Tasisulam was dosed intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms per milliliter (h*mcg/mL) on Day 1 and followed by 1.2 milligrams (mg) midazolam orally on Day 8
11031012|NCT01209832|EG000|Reported Event|Midazolam|Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1.
11031013|NCT01209832|EG001|Reported Event|Tasisulam and Midazolam|Period 2 (28 days): Tasisulam intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms per milliliter (h*mcg/mL) on Day 1 and 1.2 mg midazolam orally on Day 8.
11031014|NCT01209832|EG002|Reported Event|Tasisulam (M1)|Maintenance Period 1 (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h*mcg/mL on Day 1.
11031015|NCT01209832|EG003|Reported Event|Tasisulam (M2)|Maintenance Period 2 (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h*mcg/mL on Day 1.
11031016|NCT01209949|BG000|Baseline|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
11031017|NCT01209949|FG000|Participant Flow|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
11031018|NCT01209949|OG000|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
11031019|NCT01209949|EG000|Reported Event|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
11031020|NCT01210001|BG000|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
11031021|NCT01210001|BG001|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
11031022|NCT01210001|BG002|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
11031023|NCT01210001|BG003|Baseline|Total|Total of all reporting groups
11031024|NCT01210001|FG000|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
11031025|NCT01210001|FG001|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
11031026|NCT01210001|FG002|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
11031027|NCT01210001|OG000|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
11031028|NCT01210001|OG001|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
11031029|NCT01210001|OG002|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
11031030|NCT01210001|EG000|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
11031031|NCT01210001|EG001|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
11031032|NCT01210001|EG002|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
11031033|NCT01210079|BG000|Baseline|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
11031034|NCT01210079|BG001|Baseline|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
11031035|NCT01210079|BG002|Baseline|Total|Total of all reporting groups
11031036|NCT01210079|FG000|Participant Flow|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
11031037|NCT01210079|FG001|Participant Flow|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
11031038|NCT01210079|OG000|Outcome|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
11031039|NCT01210079|OG001|Outcome|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
11031040|NCT01210079|EG000|Reported Event|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
11031041|NCT01210079|EG001|Reported Event|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
11031042|NCT01210118|BG000|Baseline|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
11031043|NCT01210118|BG001|Baseline|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
11031044|NCT01210118|BG002|Baseline|Total|Total of all reporting groups
11031045|NCT01210118|FG000|Participant Flow|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
11031046|NCT01210118|FG001|Participant Flow|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
11031047|NCT01210118|OG000|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
11031048|NCT01210118|OG001|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
11031049|NCT01210118|OG000|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
11031050|NCT01210118|OG000|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
11031051|NCT01210118|OG000|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
11031052|NCT01210118|EG000|Reported Event|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
11031053|NCT01210118|EG001|Reported Event|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
11031054|NCT01210144|BG000|Baseline|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
11031055|NCT01210144|BG001|Baseline|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
11031056|NCT01210144|BG002|Baseline|Total|Total of all reporting groups
11031057|NCT01210144|FG000|Participant Flow|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) gonadotropin-releasing hormone (GnRH) agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
11031058|NCT01210144|FG001|Participant Flow|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
11031059|NCT01210144|OG000|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
11031060|NCT01210144|OG000|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
11031061|NCT01210144|OG001|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
11031062|NCT01210144|EG000|Reported Event|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
11031063|NCT01210144|EG001|Reported Event|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
11031064|NCT01210170|BG000|Baseline|All Study Participants|• participant with asthma were enrolled in the study
11031065|NCT01210170|FG000|Participant Flow|All Study Participants|"• Inhalation of 400 µg mometasone DPI 30 min before inhalation of 180 µg albuterol~Mometasone furoate: • Inhalation of 400 µg mometasone or placebo DPI 30 min before inhalation of 180 µg albuterol~• Inhalation of 400 µg mometasone or placebo DPI 60 min before inhalation of 180 µg albuterol"
11031066|NCT01210170|OG000|Outcome|All Participants Received 400 mcg Mometasone-30 Min|mometasone 400 mcg 30 minutes before albuterol 180 mcg inhalation
11031067|NCT01210170|OG001|Outcome|All Participants Received Placebo 30 Minutes Before Albuterol|mometasone placebo 30 minutes before albuterol 180 mcg inhalation
11031068|NCT01210170|OG002|Outcome|All Participants Received 400 mcg Mometasone Simultaneous|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol
11031069|NCT01210170|OG003|Outcome|All Participants Received Placebo Simultaneously With Albutero|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
11031070|NCT01210170|OG004|Outcome|All Participants Received 200 mcg Mometasone-30 Min|mometasone 200 mcg 30 minutes before inhalation of 180 mcg of albuterol
11031071|NCT01210170|OG005|Outcome|All Participants Received 400 mcg -60 Min|mometasone 400 mcg 60 minutes before inhalation of 180 mcg of albuterol
11031072|NCT01210170|OG006|Outcome|All Participants Received Placebo -60 Min|placebo 60 minutes before inhalation of 180 mcg of albuterol
11031073|NCT01210170|OG007|Outcome|All Participants Received 200 mcg Mometasone Simultaneous|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol
11031074|NCT01210170|OG008|Outcome|All Participants Received 200 mcg -60 Min|mometasone 200 mcg 60 minutes before inhalation of 180 mcg of albuterol
11031075|NCT01210170|OG000|Outcome|400 mcg Mometasone 30 Minutes Before Albuterol|• Inhalation of 400 µg mometasone 30 min before inhalation of 180 µg albuterol
11031076|NCT01210170|OG001|Outcome|Mometasone Placebo 30 Minutes Before Albuterol|Inhalation of mometasone placebo 30 min before inhalation of 180 µg albuterol
11031077|NCT01210170|OG002|Outcome|400 mcg Mometasone and Albuterol Simultaneously|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol.
11031078|NCT01210170|OG003|Outcome|Mometasone Placebo and Albuterol Simultaneously|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
11031079|NCT01210170|OG004|Outcome|400 mcg Mometasone 60 Minutes Before Albuterol|Inhalation of 400 µg mometasone 60 min before inhalation of 180 µg albuterol
11031080|NCT01210170|OG005|Outcome|Mometasone Placebo 60 Minutes Before Albuterol|Inhalation of mometasone placebo 60 min before inhalation of 180 µg albuterol
11031081|NCT01210170|OG006|Outcome|200 mcg Mometasone and Albuterol Simultaneously|inhalation of 200 mcg mometasone immediately before inhalation of 180 mcg albuterol
11031082|NCT01210170|OG007|Outcome|200 mcg Mometasone 60 Minutes Before Albuterol|Inhalation of 200 µg mometasone 60 min before inhalation of 180 µg albuterol
11031083|NCT01210170|OG008|Outcome|200 mcg Mometasone 30 Minutes Before Albuterol|Inhalation of 200 µg mometasone 30 min before inhalation of 180 µg albuterol
11031084|NCT01210170|EG000|Reported Event|All Study Participants|Simultaneous inhalation of 400 µg mometasone DPI and 180 µg albuterol
11031085|NCT01210222|BG000|Baseline|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
11031086|NCT01210222|FG000|Participant Flow|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
11031087|NCT01210222|OG000|Outcome|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
11031088|NCT01210222|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
11031089|NCT01210222|OG001|Outcome|Grade 1 (CTCAE v 4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
11031090|NCT01210222|OG002|Outcome|Grade 2 (CTCAE v 4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
11031091|NCT01210222|OG003|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
11031092|NCT01210222|OG004|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
11031093|NCT01210222|OG005|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
11031094|NCT01210222|EG000|Reported Event|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
11031095|NCT01210352|BG000|Baseline|Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg|6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
11031096|NCT01210352|BG001|Baseline|Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg|6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid
11031097|NCT01210352|BG002|Baseline|Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg|6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
11031098|NCT01210352|BG003|Baseline|Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg|2 to <6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
11031099|NCT01210352|BG004|Baseline|Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg|2 to <6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid
11031100|NCT01210352|BG005|Baseline|Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg|2 to <6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
11031101|NCT01210352|BG006|Baseline|Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg|0 to < 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
11031102|NCT01210352|BG007|Baseline|Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg|6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
11031103|NCT01210352|BG008|Baseline|Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg|2 to <6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
11031104|NCT01210352|BG009|Baseline|Total|Total of all reporting groups
11031105|NCT01210352|FG000|Participant Flow|Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg|6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
11031106|NCT01210352|FG001|Participant Flow|Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg|6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid
11031107|NCT01210352|FG002|Participant Flow|Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg|6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
11031108|NCT01210352|FG003|Participant Flow|Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg|2 to <6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
11031109|NCT01210352|FG004|Participant Flow|Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg|2 to <6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid
11031110|NCT01210352|FG005|Participant Flow|Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg|2 to <6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
11031111|NCT01210352|FG006|Participant Flow|Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg|0 to < 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid
11031112|NCT01210352|FG007|Participant Flow|Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg|6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
11031113|NCT01210352|FG008|Participant Flow|Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg|2 to <6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
11031114|NCT01210352|OG000|Outcome|6 Years to ≤ 12 Years Age Group in Single Dose Phase|Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
11031115|NCT01210352|OG001|Outcome|2 Years to < 6 Years Age Group in Single Dose Phase|Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
11031116|NCT01210352|OG002|Outcome|0 Years to < 2 Years Age Group in Single Dose Phase|Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to < 2 years age group
11031117|NCT01210352|OG002|Outcome|0 Years to < 2 Years Age Group in Single Dose Phase|Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to < 2 year age group
11031118|NCT01210352|OG000|Outcome|6 Years to ≤ 12 Years Age Group in Multiple Dose Phase|Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
11031119|NCT01210352|OG001|Outcome|2 Years to < 6 Years Age Group in Multiple Dose Phase|Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
11031120|NCT01210352|OG000|Outcome|6 to ≤12 Years Age Group: 0.20 mg/kg|Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group
11031121|NCT01210352|OG001|Outcome|2 to <6 Years Age Group: 0.20 mg/kg|Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
11031122|NCT01210352|OG000|Outcome|6 to ≤12 Years Age Group: 0.20 mg/kg|Percentages are based on the number of subjects ('N') in effectiveness population in each dose group in each age group in Multiple-Dose Phase
11031123|NCT01210352|OG001|Outcome|2 to <6 Years Age Group: 0.20 mg/kg|Percentages are based on the number of subjects ('N') in effectiveness population in each dose group in each age group in Multiple-Dose Phase
11031124|NCT01210352|OG000|Outcome|0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031125|NCT01210352|OG001|Outcome|0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031126|NCT01210352|OG002|Outcome|0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031127|NCT01210352|OG003|Outcome|0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031128|NCT01210352|OG004|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031129|NCT01210352|OG005|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031130|NCT01210352|OG000|Outcome|0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Tmax: The time at which Cmax was observed
11031131|NCT01210352|OG001|Outcome|0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Tmax: The time at which Cmax was observed
11031132|NCT01210352|OG002|Outcome|0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Tmax: The time at which Cmax was observed
11031133|NCT01210352|OG003|Outcome|0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Tmax: The time at which Cmax was observed
11031134|NCT01210352|OG004|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Tmax: The time at which Cmax was observed
11031135|NCT01210352|OG005|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Tmax: The time at which Cmax was observed
11031136|NCT01210352|OG000|Outcome|0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031137|NCT01210352|OG001|Outcome|0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031138|NCT01210352|OG002|Outcome|0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031139|NCT01210352|OG003|Outcome|0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031140|NCT01210352|OG004|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031141|NCT01210352|OG005|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031142|NCT01210352|OG000|Outcome|0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Tlast: The time at which Clast was observed
11031143|NCT01210352|OG001|Outcome|0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Tlast: The time at which Clast was observed
11031144|NCT01210352|OG002|Outcome|0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Tlast: The time at which Clast was observed
11031145|NCT01210352|OG003|Outcome|0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Tlast: The time at which Clast was observed
11031146|NCT01210352|OG004|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|Tlast: The time at which Clast was observed
11031147|NCT01210352|OG005|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|Tlast: The time at which Clast was observed
11031148|NCT01210352|OG000|Outcome|0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031149|NCT01210352|OG001|Outcome|0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031150|NCT01210352|OG002|Outcome|0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031151|NCT01210352|OG003|Outcome|0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031152|NCT01210352|OG004|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031153|NCT01210352|OG005|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031154|NCT01210352|OG000|Outcome|0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031155|NCT01210352|OG001|Outcome|0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031156|NCT01210352|OG002|Outcome|0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031157|NCT01210352|OG003|Outcome|0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031158|NCT01210352|OG004|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031159|NCT01210352|OG005|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031160|NCT01210352|OG000|Outcome|0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031161|NCT01210352|OG001|Outcome|0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031162|NCT01210352|OG002|Outcome|0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031163|NCT01210352|OG003|Outcome|0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031164|NCT01210352|OG004|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031165|NCT01210352|OG005|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031166|NCT01210352|OG000|Outcome|0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031167|NCT01210352|OG001|Outcome|0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031168|NCT01210352|OG002|Outcome|0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031169|NCT01210352|OG003|Outcome|0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031170|NCT01210352|OG004|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031171|NCT01210352|OG005|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031172|NCT01210352|OG000|Outcome|Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years|CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
11031173|NCT01210352|OG001|Outcome|Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years|CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
11031174|NCT01210352|OG000|Outcome|Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years|V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
11031175|NCT01210352|OG001|Outcome|Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years|V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
11031176|NCT01210352|OG000|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031177|NCT01210352|OG001|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031178|NCT01210352|OG002|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031179|NCT01210352|OG003|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
11031180|NCT01210352|OG000|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1|Tmax: The time at which Cmax was observed
11031181|NCT01210352|OG001|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1|Tmax: The time at which Cmax was observed
11031182|NCT01210352|OG002|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7|Tmax: The time at which Cmax was observed
11031183|NCT01210352|OG003|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7|Tmax: The time at which Cmax was observed
11031184|NCT01210352|OG000|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031185|NCT01210352|OG001|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031186|NCT01210352|OG002|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031187|NCT01210352|OG003|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
11031188|NCT01210352|OG000|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1|Tlast: The time at which Clast was observed
11031189|NCT01210352|OG001|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1|Tlast: The time at which Clast was observed
11031190|NCT01210352|OG002|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7|Tlast: The time at which Clast was observed
11031191|NCT01210352|OG003|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7|Tlast: The time at which Clast was observed
11031192|NCT01210352|OG000|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031193|NCT01210352|OG001|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031194|NCT01210352|OG002|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031195|NCT01210352|OG003|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
11031196|NCT01210352|OG000|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031197|NCT01210352|OG001|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031198|NCT01210352|OG002|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031199|NCT01210352|OG003|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
11031200|NCT01210352|OG000|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031201|NCT01210352|OG001|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031202|NCT01210352|OG002|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031203|NCT01210352|OG003|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
11031204|NCT01210352|OG000|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031205|NCT01210352|OG001|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031206|NCT01210352|OG002|Outcome|0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031207|NCT01210352|OG003|Outcome|0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7|t1/2: Terminal half-life, calculated as λn/(ln 2)
11031208|NCT01210352|EG000|Reported Event|6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg|All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.05 mg/kg
11031209|NCT01210352|EG001|Reported Event|6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg|All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.10 mg/kg
11031210|NCT01210352|EG002|Reported Event|6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg|All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.20 mg/kg
11031211|NCT01210352|EG003|Reported Event|2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg|All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.05 mg/kg
11031212|NCT01210352|EG004|Reported Event|2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg|All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.10 mg/kg
11031213|NCT01210352|EG005|Reported Event|2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg|All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.20 mg/kg
11031214|NCT01210352|EG006|Reported Event|0 to < 2 Years Age Group: Single Dose 0.05 mg/kg|All (serious and nonserious) AEs for the 0 to < 2 years Age Group - Single Dose 0.05 mg/kg
11031215|NCT01210352|EG007|Reported Event|6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg|All (serious and nonserious) AEs for the 0 to < 2 years Age Group - Multiple Dose 0.20 mg/kg
11031216|NCT01210352|EG008|Reported Event|2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg|All (serious and nonserious) AEs for the 2 to < 6 years Age Group - Multiple Dose 0.20 mg/kg
11031217|NCT01210443|BG000|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
11031218|NCT01210443|FG000|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
11031219|NCT01210443|OG000|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
11031220|NCT01210443|EG000|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
11031221|NCT01210495|BG000|Baseline|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
11031222|NCT01210495|BG001|Baseline|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
11031223|NCT01210495|BG002|Baseline|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
11031224|NCT01210495|BG003|Baseline|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
11031225|NCT01210495|BG004|Baseline|Total|Total of all reporting groups
11031226|NCT01210495|FG000|Participant Flow|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 milligrams (mg) twice daily (BID).
11031227|NCT01210495|FG001|Participant Flow|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
11031228|NCT01210495|FG002|Participant Flow|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
11031229|NCT01210495|FG003|Participant Flow|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
11031230|NCT01210495|OG000|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
11031231|NCT01210495|OG001|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
11031232|NCT01210495|OG000|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
11031233|NCT01210495|OG001|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
11031234|NCT01210495|EG000|Reported Event|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
11031235|NCT01210495|EG001|Reported Event|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non randomized portion of this study to determine the recommended starting dose of axitinib for this population.
11031236|NCT01210495|EG002|Reported Event|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
11031237|NCT01210495|EG003|Reported Event|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
11031238|NCT01210560|BG000|Baseline|Group 1|Group 1 participants enrolled in a 3-period, randomized, crossover design to compare multiple doses of a 90+30 mg split-dose of the tolvaptan IR formulation, a 120 mg QD dose of the tolvaptan MR formulation, and, in an incomplete block randomization, multiple doses of either 20 mg QD, 60 mg QD, or 20 mg BID tolvaptan MR formulation. All dose regimens were administered for 7 days. Placebo doses were administered in order to mask formulation and dosing regimen.
11031239|NCT01210560|BG001|Baseline|Group 2|Group 2 participants enrolled in a 3-period, randomized, crossover design to compare multiple oral doses of the tolvaptan MR formulation administered for 7 days as 20 mg QD, 60 mg QD, and 20 mg BID. Placebo capsules were administered in order to mask dosing regimen.
11031240|NCT01210560|BG002|Baseline|Total|Total of all reporting groups
11031241|NCT01210560|FG000|Participant Flow|Group 1: DAE|D = participants received MR tolvaptan 120 mg QD A = participants received MR tolvaptan 20 mg QD E = participants received IR tolvaptan 90 + 30 mg QD
11031242|NCT01210560|FG001|Participant Flow|Group 1: DBE|D = participants received MR tolvaptan 120 mg QD B = participants received MR tolvaptan 20 mg BID E = participants received IR tolvaptan 90 + 30 mg QD
11031243|NCT01210560|FG002|Participant Flow|Group 1: DCE|D = participants received MR tolvaptan 120 mg QD C = participants received MR tolvaptan 60 mg QD E = participants received IR tolvaptan 90 + 30 mg QD
11031244|NCT01210560|FG003|Participant Flow|Group 1: EAD|E = participants received IR tolvaptan 90 + 30 mg QD A = participants received MR tolvaptan 20 mg QD D = participants received MR tolvaptan 120 mg QD
11031245|NCT01210560|FG004|Participant Flow|Group 1: EBD|E = participants received IR tolvaptan 90 + 30 mg QD B = participants received MR tolvaptan 20 mg BID D = participants received MR tolvaptan 120 mg QD
11031246|NCT01210560|FG005|Participant Flow|Group 1: ECD|E = participants received IR tolvaptan 90 + 30 mg QD C = participants received MR tolvaptan 60 mg QD D = participants received MR tolvaptan 120 mg QD
11031247|NCT01210560|FG006|Participant Flow|Group 2: FGH|F = participants received MR tolvaptan 20 mg QD G = participants received MR tolvaptan 20 + 20 mg BID H = participants received MR tolvaptan 60 mg QD
11031248|NCT01210560|FG007|Participant Flow|Group 2: HFG|H = participants received MR tolvaptan 60 mg QD F = participants received MR tolvaptan 20 mg QD G = participants received MR tolvaptan 20 + 20 mg BID
11031249|NCT01210560|FG008|Participant Flow|Group 2: GHF|G = participants received MR tolvaptan 20 + 20 mg BID H = participants received MR tolvaptan 60 mg QD F = participants received MR tolvaptan 20 mg QD
11031250|NCT01210560|OG000|Outcome|MR 20 mg|Participants received MR tolvaptan 20 mg QD.
11031251|NCT01210560|OG001|Outcome|MR 20+20 mg|Participants received MR tolvaptan 20 mg BID.
11031252|NCT01210560|OG002|Outcome|MR 60 mg|Participants received MR tolvaptan 60 mg QD.
11031253|NCT01210560|OG003|Outcome|MR 120 mg|Participants received MR tolvaptan 120 mg QD.
11031254|NCT01210560|OG004|Outcome|IR 90+30 mg|Participants received IR tolvaptan 90+30 mg QD.
11031255|NCT01210560|OG002|Outcome|MR 60 mg|Participants received MR tolvaptan 60 mg Q
11031256|NCT01210560|EG000|Reported Event|MR 20 mg|Participants received MR tolvaptan 20 mg QD.
11031257|NCT01210560|EG001|Reported Event|MR 20+20 mg|Participants received MR tolvaptan 20 mg BID.
11031258|NCT01210560|EG002|Reported Event|MR 60 mg|Participants received MR tolvaptan 60 mg QD.
11031259|NCT01210560|EG003|Reported Event|MR 120 mg|Participants received MR tolvaptan 120 mg QD.
11031260|NCT01210560|EG004|Reported Event|IR 90+30 mg|Participants received IR tolvaptan 90+30 mg QD.
11031261|NCT01210651|BG000|Baseline|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
11031262|NCT01210651|BG001|Baseline|Attention Control Education Group|Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.
11031263|NCT01210651|BG002|Baseline|Total|Total of all reporting groups
11031264|NCT01210651|FG000|Participant Flow|Hatha Yoga Practice Group|Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks.
11031265|NCT01210651|FG001|Participant Flow|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
11031266|NCT01210651|OG000|Outcome|Hatha Yoga Practice Group|Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
11031267|NCT01210651|OG001|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
11031268|NCT01210651|OG000|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
11031269|NCT01210651|OG001|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
11031270|NCT01210651|OG000|Outcome|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
11031271|NCT01210651|OG001|Outcome|Attention Control Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
11031272|NCT01210651|EG000|Reported Event|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks. week for a total of 8 weeks.
11031273|NCT01210651|EG001|Reported Event|Attention Control Group|Participants in this group met for 90-minute education seminars on yoga history and philosophy twice a week for a total of 8 weeks.
11031274|NCT01210664|BG000|Baseline|Polyclonal Regulatory T Cells|"Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion~Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells: The researchers will multiply/expand the Tregs in the laboratory using anti-CD3/anti-CD28 coated beads plus IL-2. Then, the Tregs will be infused back into the patient in a single infusion. The first cohort will receive 0.05 x10^8 cells. The second cohort will receive 0.4 x10^8 cells. The third cohort will receive 3.2 x10^8 cells. The fourth cohort will receive 26 x10^8 cells."
11031275|NCT01210664|FG000|Participant Flow|Polyclonal Regulatory T Cells, 0.05 x10^8 Cells|Cohort 1: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 0.05 x10^8 cells of Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion
11031276|NCT01210664|FG001|Participant Flow|Polyclonal Regulatory T Cells, 0.4 x10^8 Cells|Cohort 2: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 0.4 x10^8 cells of Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion
11031277|NCT01210664|FG002|Participant Flow|Polyclonal Regulatory T Cells, 3.2 x10^8 Cells|Cohort 3: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 3.2 x10^8 cells of Ex vivo expanded Human Autologous Polyclonal Regulatory T Cells by infusion
11031278|NCT01210664|FG003|Participant Flow|Polyclonal Regulatory T Cells, 26 x10^8 Cells|Cohort 4: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 26 x10^8 cells of Ex vivo expanded Human Autologous Polyclonal Regulatory T Cells by infusion
11031279|NCT01210664|OG000|Outcome|Cohort 1|Target dose of 0.05 X10^8 cells
11031280|NCT01210664|OG001|Outcome|Cohort 2|Target dose of 0.4 X10^8 cells
11031281|NCT01210664|OG002|Outcome|Cohort 3|Target dose 3.2 x10^8 cells
11031282|NCT01210664|OG003|Outcome|Cohort 4|Target dose 26 x10^8 cells
11031283|NCT01210664|EG000|Reported Event|Cohort 1|Target dose of 0.05 X10^8 cells
11031284|NCT01210664|EG001|Reported Event|Cohort 2|Target dose of 0.4 X10^8 cells
11031285|NCT01210664|EG002|Reported Event|Cohort 3|Target dose 3.2 x10^8 cells
11031286|NCT01210664|EG003|Reported Event|Cohort 4|Target dose 26 x10^8 cells
11031287|NCT01210690|BG000|Baseline|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
11031288|NCT01210690|FG000|Participant Flow|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
11031289|NCT01210690|OG000|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
11031290|NCT01210690|OG000|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and is not influenced by the study protocol.
11031291|NCT01210690|EG000|Reported Event|Patients, 1 - 11 Mths Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
11031292|NCT01210716|BG000|Baseline|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
11031293|NCT01210716|FG000|Participant Flow|Spectra First, Then AMICUS|Patients randomized to Control (Spectra) procedure first. Second procedure performed was Test (AMICUS).
11031294|NCT01210716|FG001|Participant Flow|AMICUS First, Then Spectra|Patients randomized to Test (AMICUS) procedure first. Second procedure performed was Control (Spectra).
11031295|NCT01210716|OG000|Outcome|AMICUS (Test)|Each evaluable patient underwent one complete TPE procedure on the AMICUS separator.
11031296|NCT01210716|OG001|Outcome|Spectra (Control)|Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator.
11031297|NCT01210716|OG000|Outcome|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
11031298|NCT01210716|EG000|Reported Event|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
11031299|NCT01210807|BG000|Baseline|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
11031300|NCT01210807|BG001|Baseline|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
11031301|NCT01210807|BG002|Baseline|Total|Total of all reporting groups
11031302|NCT01210807|FG000|Participant Flow|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
11031303|NCT01210807|FG001|Participant Flow|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
11031304|NCT01210807|OG000|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
11031305|NCT01210807|OG001|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
11031306|NCT01210807|EG000|Reported Event|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
11031307|NCT01210807|EG001|Reported Event|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
11031308|NCT01210820|BG000|Baseline|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
11031309|NCT01210820|BG001|Baseline|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
11031310|NCT01210820|BG002|Baseline|Total|Total of all reporting groups
11031311|NCT01210820|FG000|Participant Flow|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
11031312|NCT01210820|FG001|Participant Flow|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
11031313|NCT01210820|OG000|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
11031314|NCT01210820|OG001|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
11031315|NCT01210820|EG000|Reported Event|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
11031316|NCT01210820|EG001|Reported Event|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
11031317|NCT01211106|BG000|Baseline|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
11031318|NCT01211106|BG001|Baseline|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
11031319|NCT01211106|BG002|Baseline|Total|Total of all reporting groups
11031320|NCT01211106|FG000|Participant Flow|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
11031321|NCT01211106|FG001|Participant Flow|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
11031322|NCT01211106|OG000|Outcome|Arm 1: Integrated Conditions|Motivational enhancement therapy combined with Prolonged Exposure therapy.
11031323|NCT01211106|OG001|Outcome|Arm 2 Sequential Therapy|MET followed by Prolonged Exposure
11031324|NCT01211106|OG000|Outcome|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
11031325|NCT01211106|OG001|Outcome|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
11031326|NCT01211106|EG000|Reported Event|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
11031327|NCT01211106|EG001|Reported Event|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
11031328|NCT01211145|BG000|Baseline|Placebo|Placebo to ZOMIG nasal spray
11031329|NCT01211145|BG001|Baseline|ZOMIG 0.5 mg|ZOMIG nasal spray
11031330|NCT01211145|BG002|Baseline|ZOMIG 2.5 mg|ZOMIG nasal spray
11031331|NCT01211145|BG003|Baseline|ZOMIG 5 mg|ZOMIG nasal spray
11031332|NCT01211145|BG004|Baseline|Total|Total of all reporting groups
11031333|NCT01211145|FG000|Participant Flow|Placebo|Placebo to ZOMIG nasal spray
11031334|NCT01211145|FG001|Participant Flow|ZOMIG 0.5 mg|ZOMIG nasal spray
11031335|NCT01211145|FG002|Participant Flow|ZOMIG 2.5 mg|ZOMIG nasal spray
11031336|NCT01211145|FG003|Participant Flow|ZOMIG 5 mg|ZOMIG nasal spray
11031337|NCT01211145|OG000|Outcome|Placebo|Placebo to ZOMIG nasal spray
11031338|NCT01211145|OG001|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
11031339|NCT01211145|OG002|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
11031340|NCT01211145|OG003|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
11031341|NCT01211145|EG000|Reported Event|Placebo|Placebo to ZOMIG nasal spray
11031342|NCT01211145|EG001|Reported Event|ZOMIG 0.5 mg|ZOMIG nasal spray
11031343|NCT01211145|EG002|Reported Event|ZOMIG 2.5 mg|ZOMIG nasal spray
11031344|NCT01211145|EG003|Reported Event|ZOMIG 5 mg|ZOMIG nasal spray
11031345|NCT01211184|BG000|Baseline|Fasting|patients undergo surgery in the fasting state
11031346|NCT01211184|BG001|Baseline|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
11031347|NCT01211184|BG002|Baseline|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
11031348|NCT01211184|BG003|Baseline|Total|Total of all reporting groups
11031349|NCT01211184|FG000|Participant Flow|Fasting|patients undergo surgery in the fasting state
11031350|NCT01211184|FG001|Participant Flow|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
11031351|NCT01211184|FG002|Participant Flow|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
11031352|NCT01211184|OG000|Outcome|Fasting Group|Patients did not ingest any drink or food from midnight before the surgery.
11031353|NCT01211184|OG001|Outcome|Water Group|Patients drank 800 ml of tap water 2 hrs before entering the operating room
11031354|NCT01211184|OG002|Outcome|Nutrition Group|Patients drank 800 ml in the evening before surgery and 400 ml 2 hours before surgery of a commercially available carbohydrate drink (PreOp)
11031355|NCT01211184|OG000|Outcome|Fasting|Fasting before surgery
11031356|NCT01211184|OG001|Outcome|Water Group|Patients drank 800 ml of water 2 hrs before surgery
11031357|NCT01211184|OG002|Outcome|Nutrition Group|Drank a carbohydrate drink 800 ml in the evening before surgery and 400 ml 2 hrs before surgery
11031358|NCT01211184|EG000|Reported Event|Fasting|patients undergo surgery in the fasting state
11031359|NCT01211184|EG001|Reported Event|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
11031360|NCT01211184|EG002|Reported Event|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
11031361|NCT01211197|BG000|Baseline|Study Overall|"An open label, randomised, three-way crossover study. The three treatments administered were~Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~A washout period of at least 7 days was respected between drug administrations."
11031362|NCT01211197|FG000|Participant Flow|FDC Fasted / Individual Tablets Fasted / FDC Fed|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin (BI 10773) and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
11031363|NCT01211197|FG001|Participant Flow|FDC Fasted / FDC Fed / Individual Tablets Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
11031364|NCT01211197|FG002|Participant Flow|Individual Tablets Fasted / FDC Fasted / FDC Fed|"Patients received the three treatments in the following order:~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
11031365|NCT01211197|FG003|Participant Flow|Individual Tablets Fasted / FDC Fed / FDC Fasted|"Patients received the three treatments in the following order:~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
11031366|NCT01211197|FG004|Participant Flow|FDC Fed / FDC Fasted / Individual Tablets Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
11031367|NCT01211197|FG005|Participant Flow|FDC Fed / Individual Tablets Fasted / FDC Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
11031368|NCT01211197|OG000|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
11031369|NCT01211197|OG001|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
11031370|NCT01211197|OG002|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
11031371|NCT01211197|EG000|Reported Event|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
11031372|NCT01211197|EG001|Reported Event|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
11031373|NCT01211197|EG002|Reported Event|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
11031374|NCT01211262|BG000|Baseline|IMCgp100 Weekly Dosing Regimen|Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
11031375|NCT01211262|BG001|Baseline|IMCgp100 Daily Dosing Regimen|Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle
11031376|NCT01211262|BG002|Baseline|Total|Total of all reporting groups
11031377|NCT01211262|FG000|Participant Flow|IMCgp100 Weekly Dosing Regimen|Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
11031378|NCT01211262|FG001|Participant Flow|IMCgp100 Daily Dosing Regimen|Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
11031379|NCT01211262|OG000|Outcome|IMCgp100 Weekly Dosing Regimen|Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
11031380|NCT01211262|OG000|Outcome|IMCgp100 Daily Dosing Regimen|Daily intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
11031381|NCT01211262|OG001|Outcome|IMCgp100 Daily Dosing Regimen|Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
11031382|NCT01211262|OG001|Outcome|IMCgp100 Daily Dosing Regimen|Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment.
11031383|NCT01211262|OG000|Outcome|IMCgp100 Daily Dosing Regimen|Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
11031384|NCT01211262|EG000|Reported Event|IMCgp100 Weekly Dosing Regimen|Weekly intravenous (IV) infusions of IMCgp100 at the weekly maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) over treatment cycles of eight weeks each.
11031385|NCT01211262|EG001|Reported Event|IMCgp100 Daily Dosing Regimen|Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six week treatment cycle at the MTD/daily RP2D.
11031386|NCT01211288|BG000|Baseline|HIV Negative Group|"This group contains participants consented to receive implants and identified as negative for HIV~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031387|NCT01211288|BG001|Baseline|HIV Positive Group|"This group contains participants consented to receive implants and identified as positive for HIV~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031388|NCT01211288|BG002|Baseline|Total|Total of all reporting groups
11031389|NCT01211288|FG000|Participant Flow|HIV Negative Group|"This group contains participants consented to receive implants and identified as negative for HIV~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031390|NCT01211288|FG001|Participant Flow|HIV Positive Group|"This group contains participants consented to receive implants and identified as positive for HIV~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031391|NCT01211288|OG000|Outcome|HIV Negative Group|"This group contains participants consented to receive implants and identified as negative for HIV~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031392|NCT01211288|OG001|Outcome|HIV Positive Group|"This group contains participants consented to receive implants and identified as positive for HIV~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031393|NCT01211288|OG000|Outcome|HIV Negative Group|"This group contains participants consented to receive implants and identified as negative for HIV. Some participants has more than one implant.~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031394|NCT01211288|OG001|Outcome|HIV Positive Group|"This group contains participants consented to receive implants and identified as positive for HIV.Some participants has more than one implant.~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031395|NCT01211288|EG000|Reported Event|HIV Negative Group|"This group contains participants consented to receive implants and identified as negative for HIV~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031396|NCT01211288|EG001|Reported Event|HIV Positive Group|"This group contains participants consented to receive implants and identified as positive for HIV~Astra implants: Root form OsseoSpeed TX Astra Tech Implant System"
11031397|NCT01211340|BG000|Baseline|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
11031398|NCT01211340|BG001|Baseline|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
11031399|NCT01211340|BG002|Baseline|Total|Total of all reporting groups
11031400|NCT01211340|FG000|Participant Flow|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
11031401|NCT01211340|FG001|Participant Flow|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
11031402|NCT01211340|OG000|Outcome|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
11031403|NCT01211340|OG001|Outcome|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
11031404|NCT01211340|EG000|Reported Event|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
11031405|NCT01211340|EG001|Reported Event|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
11031406|NCT01211483|BG000|Baseline|Phase 1b: U3127 18mg/kg + Erlotinib|Participants who received U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031407|NCT01211483|BG001|Baseline|Phase 2: U3-1287 18 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031408|NCT01211483|BG002|Baseline|Phase 2: U3-1287 9 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 9 mg/kg IV Q3W and Erlotinib 150 mg/day PO.
11031409|NCT01211483|BG003|Baseline|Phase 2: Placebo + Erlotinib|Participants who were randomized to receive placebo matching U3-1287 IV Q3W and Erlotinib150 mg/day PO.
11031410|NCT01211483|BG004|Baseline|Total|Total of all reporting groups
11031411|NCT01211483|FG000|Participant Flow|Phase 1b: U31287 18 mg/kg + Erlotinib|Participants who received U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031412|NCT01211483|FG001|Participant Flow|Phase 2: U3-1287 18 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031413|NCT01211483|FG002|Participant Flow|Phase 2: U3-1287 9 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 9 mg/kg IV Q3W and Erlotinib 150 mg/day PO.
11031414|NCT01211483|FG003|Participant Flow|Phase 2: Placebo + Erlotinib|Participants who were randomized to receive placebo matching U3-1287 IV Q3W and Erlotinib150 mg/day PO.
11031415|NCT01211483|OG000|Outcome|Phase 2: U3-1287 18 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031416|NCT01211483|OG001|Outcome|Phase 2: U3-1287 9 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 9 mg/kg IV Q3W and Erlotinib 150 mg/day PO.
11031417|NCT01211483|OG002|Outcome|Phase 2: Placebo + Erlotinib|Participants who were randomized to receive placebo matching U3-1287 IV Q3W and Erlotinib150 mg/day PO.
11031418|NCT01211483|OG000|Outcome|Phase 1b and Phase 2: U31287 18 mg/kg + Erlotinib|Participants who received U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO). Phase 1b and Phase 2 PK analysis sets were combined for the PK analyses.
11031419|NCT01211483|OG000|Outcome|Phase 1b: U3127 18mg/kg + Erlotinib|Participants who received U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031420|NCT01211483|OG001|Outcome|Phase 2: U3-1287 18 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031421|NCT01211483|OG002|Outcome|Phase 2: U3-1287 9 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 9 mg/kg IV Q3W and Erlotinib 150 mg/day PO.
11031422|NCT01211483|OG003|Outcome|Phase 2: Placebo + Erlotinib|Participants who were randomized to receive placebo matching U3-1287 IV Q3W and Erlotinib150 mg/day PO.
11031423|NCT01211483|EG000|Reported Event|Phase 1b: U31287 18mg/kg + Erlotinib|Participants who received U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031424|NCT01211483|EG001|Reported Event|Phase 2: U3-1287 18 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 18 mg/kg intravenously (IV) every three weeks (Q3W) and Erlotinib 150 mg/day orally (PO).
11031425|NCT01211483|EG002|Reported Event|Phase 2: U3-1287 9 mg/kg + Erlotinib|Participants who were randomized to receive U3-1287 9 mg/kg IV Q3W and Erlotinib 150 mg/day PO.
11031426|NCT01211483|EG003|Reported Event|Phase 2: Placebo + Erlotinib|Participants who were randomized to receive placebo matching U3-1287 IV Q3W and Erlotinib150 mg/day PO.
11031427|NCT01211522|BG000|Baseline|Haloperidol|"Haloperidol~Haloperidol: Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU."
11031428|NCT01211522|BG001|Baseline|Ziprasidone|"Ziprasidone~Ziprasidone: Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU."
11031429|NCT01211522|BG002|Baseline|Placebo|"Placebo~Placebo: Placebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU."
11031430|NCT01211522|BG003|Baseline|Total|Total of all reporting groups
11031431|NCT01211522|FG000|Participant Flow|Haloperidol|"Haloperidol~Haloperidol: Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU."
11031432|NCT01211522|FG001|Participant Flow|Ziprasidone|"Ziprasidone~Ziprasidone: Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU."
11031433|NCT01211522|FG002|Participant Flow|Placebo|"Placebo~Placebo: Placebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU."
11031434|NCT01211522|OG000|Outcome|Haloperidol|"Haloperidol~Haloperidol: Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU."
11031435|NCT01211522|OG001|Outcome|Ziprasidone|"Ziprasidone~Ziprasidone: Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU."
11031436|NCT01211522|OG002|Outcome|Placebo|"Placebo~Placebo: Placebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU."
11031437|NCT01211522|EG000|Reported Event|Haloperidol|"Haloperidol~Haloperidol: Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU."
11031438|NCT01211522|EG001|Reported Event|Ziprasidone|"Ziprasidone~Ziprasidone: Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU."
11031439|NCT01211522|EG002|Reported Event|Placebo|"Placebo~Placebo: Placebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU."
11031440|NCT01211535|BG000|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
11031441|NCT01211535|BG001|Baseline|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
11031442|NCT01211535|BG002|Baseline|Total|Total of all reporting groups
11031443|NCT01211535|FG000|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
11031444|NCT01211535|FG001|Participant Flow|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
11031445|NCT01211535|OG000|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
11031446|NCT01211535|OG001|Outcome|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
11031447|NCT01211535|EG000|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
11031448|NCT01211535|EG001|Reported Event|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
11031449|NCT01211600|BG000|Baseline|Suture|Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
11031450|NCT01211600|BG001|Baseline|Staples|Interrupted Ethicon Staples
11031451|NCT01211600|BG002|Baseline|Total|Total of all reporting groups
11031452|NCT01211600|FG000|Participant Flow|Suture|Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
11031453|NCT01211600|FG001|Participant Flow|Staples|Interrupted Ethicon Staples
11031454|NCT01211600|OG000|Outcome|Suture|Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
11031455|NCT01211600|OG001|Outcome|Staples|Interrupted Ethicon Staples
11031456|NCT01211600|OG000|Outcome|Staples|"Interrupted Ethicon Staples~Staples: Interrupted Ethicon Staples"
11031457|NCT01211600|OG001|Outcome|Suture|"Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)~Suture: Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)"
11031458|NCT01211600|EG000|Reported Event|Suture|Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
11031459|NCT01211600|EG001|Reported Event|Staples|Interrupted Ethicon Staples
11031460|NCT01211613|BG000|Baseline|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
11031461|NCT01211613|BG001|Baseline|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
11031462|NCT01211613|BG002|Baseline|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
11031463|NCT01211613|BG003|Baseline|Total|Total of all reporting groups
11031464|NCT01211613|FG000|Participant Flow|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
11031465|NCT01211613|FG001|Participant Flow|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
11031466|NCT01211613|FG002|Participant Flow|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
11031467|NCT01211613|OG000|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
11031468|NCT01211613|OG001|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
11031469|NCT01211613|OG002|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
11031470|NCT01211613|EG000|Reported Event|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
11031471|NCT01211613|EG001|Reported Event|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
11031472|NCT01211613|EG002|Reported Event|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
11031473|NCT01211665|BG000|Baseline|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
11031474|NCT01211665|BG001|Baseline|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
11031475|NCT01211665|BG002|Baseline|Total|Total of all reporting groups
11031476|NCT01211665|FG000|Participant Flow|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
11031477|NCT01211665|FG001|Participant Flow|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
11031478|NCT01211665|OG000|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
11031479|NCT01211665|OG001|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
11031480|NCT01211665|EG000|Reported Event|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
11031481|NCT01211665|EG001|Reported Event|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
11031482|NCT01211730|BG000|Baseline|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
11031483|NCT01211730|BG001|Baseline|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
11031484|NCT01211730|BG002|Baseline|Total|Total of all reporting groups
11031485|NCT01211730|FG000|Participant Flow|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
11031486|NCT01211730|FG001|Participant Flow|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
11031487|NCT01211730|OG000|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
11031488|NCT01211730|OG001|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
11031489|NCT01211730|EG000|Reported Event|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
11031490|NCT01211730|EG001|Reported Event|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
11031491|NCT01211769|BG000|Baseline|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
11031492|NCT01211769|BG001|Baseline|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
11031493|NCT01211769|BG002|Baseline|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
11031494|NCT01211769|BG003|Baseline|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
11031495|NCT01211769|BG004|Baseline|Total|Total of all reporting groups
11031496|NCT01211769|FG000|Participant Flow|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
11031497|NCT01211769|FG001|Participant Flow|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
11031498|NCT01211769|FG002|Participant Flow|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
11031499|NCT01211769|FG003|Participant Flow|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
11031500|NCT01211769|OG000|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
11031501|NCT01211769|OG001|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
11031502|NCT01211769|OG002|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
11031503|NCT01211769|OG003|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
11031504|NCT01211769|EG000|Reported Event|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
11031505|NCT01211769|EG001|Reported Event|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
11031506|NCT01211769|EG002|Reported Event|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
11031507|NCT01211769|EG003|Reported Event|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
11031508|NCT01211873|BG000|Baseline|Magnevist (Gadopentetate Dimeglumine)|adults received Magnevist as 1:2 ratio compared to Dotarem
11031509|NCT01211873|BG001|Baseline|Dotarem (Gadoterate Meglumine)|adults received Dotarem as 2:1 ratio compared to Magnevist.
11031510|NCT01211873|BG002|Baseline|Dotarem 2 (Gadoterate Meglumine)|All children were assigned to Dotarem
11031511|NCT01211873|BG003|Baseline|Total|Total of all reporting groups
11031512|NCT01211873|FG000|Participant Flow|Dotarem (Gadoterate Meglumine)|Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
11031513|NCT01211873|FG001|Participant Flow|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
11031514|NCT01211873|FG002|Participant Flow|Dotarem 2 (Gadoterate Meglumine)|Pediatric patients were assigned to Dotarem group only
10887026|NCT00498485|BG000|Baseline|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
10887027|NCT00498485|BG001|Baseline|Xyrem|Xyrem: Same as for Placebo
10887028|NCT00498485|BG002|Baseline|Total|Total of all reporting groups
10887029|NCT00498485|FG000|Participant Flow|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
10887030|NCT00498485|FG001|Participant Flow|Xyrem|Xyrem: Same as for Placebo
10887031|NCT00498485|OG000|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
10887032|NCT00498485|OG001|Outcome|Drug Treated|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
10887033|NCT00498485|OG000|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
10887034|NCT00498485|OG001|Outcome|Xyrem|Xyrem: Same as for Placebo
10887035|NCT00498485|EG000|Reported Event|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
10887036|NCT00498485|EG001|Reported Event|Xyrem|Xyrem: Same as for Placebo
11031515|NCT01211873|OG000|Outcome|Dotarem (Gadoterate Meglumine) - PRE|Any sequence acquired prior to injection of Dotarem was pooled as PRE
10887037|NCT00498550|BG000|Baseline|Clozapine|Clozapine, Clozaril
10887038|NCT00498550|BG001|Baseline|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
10887039|NCT00498550|BG002|Baseline|Total|Total of all reporting groups
10887040|NCT00498550|FG000|Participant Flow|Clozapine|Clozapine, Clozaril
11031516|NCT01211873|OG001|Outcome|Dotarem (Gadoterate Meglumine) - PAIRED|All sequences pre- and post-injection of Dotarem were pooled as PAIRED
11031517|NCT01211873|OG002|Outcome|Magnevist (Gadopentetate Dimeglumine) - PRE|Any sequence acquired prior to injection of Magnevist was pooled as PRE
11031518|NCT01211873|OG003|Outcome|Magnevist (Gadopentetate Dimeglumine) - PAIRED|All sequences pre- and post-injection of Magnevist were pooled as PAIRED
11031519|NCT01211873|EG000|Reported Event|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adults
11031520|NCT01211873|EG001|Reported Event|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
11031521|NCT01211873|EG002|Reported Event|Dotarem 2 (Gadoterate Meglumine )|children were only assigned to Dotarem
11031522|NCT01212094|BG000|Baseline|Placebo|Group administered placebo
11031523|NCT01212094|BG001|Baseline|Rituximab|Group administered active drug
11031524|NCT01212094|BG002|Baseline|Baseline|Patients in their first year baseline prior to treatment phase
11031525|NCT01212094|BG003|Baseline|Total|Total of all reporting groups
11031526|NCT01212094|FG000|Participant Flow|Baseline|Patients in their first year baseline prior to study drug phase
11031527|NCT01212094|FG001|Participant Flow|Placebo|Group administered placebo
11031528|NCT01212094|FG002|Participant Flow|Rituximab|Group administered active drug
11031529|NCT01212094|OG000|Outcome|Placebo|Group administered placebo
11031530|NCT01212094|OG001|Outcome|Rituximab|Group administered active drug
11031531|NCT01212094|EG000|Reported Event|Placebo|Placebo group
11031532|NCT01212094|EG001|Reported Event|Rituximab|Group who got active drug
11031533|NCT01212094|EG002|Reported Event|Baseline|Patients in their first year baseline prior to study drug phase
11031534|NCT01212107|BG000|Baseline|Part A: 2 mg FGF Receptor QD|Part A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
11031535|NCT01212107|BG001|Baseline|Part A: 4 mg FGF Receptor QD|Part A: Dose escalation 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
11031536|NCT01212107|BG002|Baseline|Part A: 10 mg FGF Receptor QD|Part A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
11031537|NCT01212107|BG003|Baseline|Part A: 10 mg FGF Receptor QD + Phosphate Binders|Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle
11031538|NCT01212107|BG004|Baseline|Part A: 8 mg FGF Receptor BID|Part A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle
11031539|NCT01212107|BG005|Baseline|Part A: 10 mg FGF Receptor BID|Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031540|NCT01212107|BG006|Baseline|Part A: 14 mg FGF Receptor BID|Part A: Dose escalation 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031541|NCT01212107|BG007|Baseline|Part A: 18 mg FGF Receptor BID|Part A: Dose escalation18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031542|NCT01212107|BG008|Baseline|Part A: 24 mg FGF Receptor BID|Part A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031543|NCT01212107|BG009|Baseline|Part A: 18 mg FGF Receptor BID Extension|Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
11031544|NCT01212107|BG010|Baseline|Part A: 16 mg FGF Receptor BID|Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
11031545|NCT01212107|BG011|Baseline|Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer )|Part B: Dose determined by part a dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
11031546|NCT01212107|BG012|Baseline|Total|Total of all reporting groups
11031547|NCT01212107|FG000|Participant Flow|Part A: 2 mg FGF Receptor QD|"Part A: Dose escalation~2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle."
11031548|NCT01212107|FG001|Participant Flow|Part A: 4 mg FGF Receptor QD|"Part A: Dose escalation~4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle."
11031549|NCT01212107|FG002|Participant Flow|Part A: 10 mg FGF Receptor QD|"Part A: Dose escalation~10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle."
11031550|NCT01212107|FG003|Participant Flow|Part A: 10 mg FGF Receptor QD + Phosphate Binders|Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
11031551|NCT01212107|FG004|Participant Flow|Part A: 8 mg FGF Receptor BID|"Part A: Dose escalation~8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle."
11031552|NCT01212107|FG005|Participant Flow|Part A: 10 mg FGF Receptor BID|Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031553|NCT01212107|FG006|Participant Flow|Part A: 14 mg FGF Receptor BID|Part A: Dose escalation 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031554|NCT01212107|FG007|Participant Flow|Part A: 18 mg FGF Receptor BID|"Part A: Dose escalation~18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle."
11031555|NCT01212107|FG008|Participant Flow|Part A: 24 mg FGF Receptor BID|"Part A: Dose escalation~24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle."
11031556|NCT01212107|FG009|Participant Flow|Part A: 18 mg FGF Receptor BID Extension|Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
11031557|NCT01212107|FG010|Participant Flow|Part A: 16 mg FGF Receptor BID|Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
11031558|NCT01212107|FG011|Participant Flow|Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer)|"Part B: Dose determined by part a dose escalation~16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031559|NCT01212107|OG000|Outcome|Part A Participants|"Part A: Dose escalation~Cohort 1: 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.~Cohort2: 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.~Cohort3: 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.~Cohort4: 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.~Cohort5: 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.~Cohort6: 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.~Cohort7: 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.~Cohort8: 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.~Cohort9: 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.~Cohort10: 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.~Cohort11: 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031560|NCT01212107|OG000|Outcome|Part A: 2 mg FGF Receptor QD|"Part A: Dose escalation~2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle."
11031561|NCT01212107|OG001|Outcome|Part A: 4 mg FGF Receptor QD|"Part A: Dose escalation~4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle."
11031562|NCT01212107|OG002|Outcome|Part A: 10 mg FGF Receptor QD|"Part A: Dose escalation~10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle."
11031563|NCT01212107|OG003|Outcome|Part A: 10 mg FGF Receptor QD + Phosphate Binders|"Part A: Dose escalation~10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle."
11031564|NCT01212107|OG004|Outcome|Part A: 8 mg FGF Receptor BID|"Part A: Dose escalation~8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle."
11031565|NCT01212107|OG005|Outcome|Part A: 10 mg FGF Receptor BID|"Part A: Dose escalation~10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle."
11031566|NCT01212107|OG006|Outcome|Part A: 14 mg FGF Receptor BID|"Part A: Dose escalation~14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle."
11031567|NCT01212107|OG007|Outcome|Part A: 18 mg FGF Receptor BID|"Part A: Dose escalation~18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle."
11031568|NCT01212107|OG008|Outcome|Part A: 24 mg FGF Receptor BID|"Part A: Dose escalation~24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle."
11031569|NCT01212107|OG009|Outcome|Part A: 18 mg FGF Receptor BID Extension|"Part A: Dose escalation~18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031570|NCT01212107|OG010|Outcome|Part A: 16 mg FGF Receptor BID|"Part A: Dose escalation~16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle"
11031571|NCT01212107|OG011|Outcome|Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer)|"Part B: Dose confirmation~16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031572|NCT01212107|OG007|Outcome|Part A: 18 mg FGF Receptor BID|18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031573|NCT01212107|OG009|Outcome|18 mg FGF Receptor BID Extension|"Part A: Dose escalation~18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031574|NCT01212107|OG010|Outcome|Part A: 16 mg FGF Receptor BID|"Part A:~16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031575|NCT01212107|OG009|Outcome|Part A: 16 mg FGF Receptor BID|"Part A: Dose escalation~16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031576|NCT01212107|OG010|Outcome|Part B: 16 mg FGF Receptor BID (NSCLS)|"Part B: Dose confirmation~16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031577|NCT01212107|OG011|Outcome|Part B: 16 mg FGF Receptor BID (Gastric Cancer)|"Part B: Dose confirmation~16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031578|NCT01212107|OG000|Outcome|Part A: 2 mg FGF Receptor QD|Part A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
11031579|NCT01212107|OG002|Outcome|Part A: 10 mg FGF Receptor QD|Part A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
11031580|NCT01212107|OG003|Outcome|Part A: 10 mg FGF Receptor QD + Phosphate Binders|Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
11031581|NCT01212107|OG004|Outcome|Part A: 8 mg FGF Receptor BID|Part A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
11031582|NCT01212107|OG005|Outcome|Part A: 10 mg FGF Receptor BID|Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031583|NCT01212107|OG006|Outcome|Part A: 14 mg FGF Receptor BID|Part A: Dose escalation 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031584|NCT01212107|OG007|Outcome|Part A:18 mg FGF Receptor BID|Part A: Dose escalation 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031585|NCT01212107|OG008|Outcome|Part A: 24 mg FGF Receptor BID|Part A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031586|NCT01212107|OG009|Outcome|Part A: 16 mg FGF Receptor BID|Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
11031587|NCT01212107|EG000|Reported Event|Part A: 2 mg FGF Receptor QD|Part A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
11031588|NCT01212107|EG001|Reported Event|Part A: 4 mg FGF Receptor QD|Part A: Dose escalation 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
11031589|NCT01212107|EG002|Reported Event|Part A: 10 mg FGF Receptor QD|Part A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
11031590|NCT01212107|EG003|Reported Event|Part A: 10 mg FGF Receptor QD + Phosphate Binders|Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
11031591|NCT01212107|EG004|Reported Event|Part A: 8 mg FGF Receptor BID|Part A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
11031592|NCT01212107|EG005|Reported Event|Part A: 10 mg FGF Receptor BID|Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031593|NCT01212107|EG006|Reported Event|Part A: 14 mg FGF Receptor BID|Part A: Dose escalation 14 FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031594|NCT01212107|EG007|Reported Event|Part A: 18 mg FGF Receptor BID|Part A: Dose escalation 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031595|NCT01212107|EG008|Reported Event|Part A: 24 mg FGF Receptor BID|Part A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
11031596|NCT01212107|EG009|Reported Event|Part A: 18 mg FGF Receptor BID Extension|Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
11031597|NCT01212107|EG010|Reported Event|Part A: 16 mg FGF Receptor BID|Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
11031598|NCT01212107|EG011|Reported Event|Part B: 16 mg FGF Receptor BID (NSCLS and Gastric Cancer)|"Part B: Dose determined by part a dose escalation~16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle."
11031599|NCT01212159|BG000|Baseline|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
11031600|NCT01212159|BG001|Baseline|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
11031601|NCT01212159|BG002|Baseline|Total|Total of all reporting groups
11031602|NCT01212159|FG000|Participant Flow|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
11031603|NCT01212159|FG001|Participant Flow|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
11031604|NCT01212159|OG000|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
11031605|NCT01212159|OG001|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
11031606|NCT01212159|EG000|Reported Event|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
11031607|NCT01212159|EG001|Reported Event|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
11031608|NCT01212172|BG000|Baseline|Side-by Side Comparsion of Soprano/SHR to Light Sheer|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.~LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
11031609|NCT01212172|FG000|Participant Flow|Soprano Duet 810 nm Diode Laser|"Soprano Duet 810 nm diode laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
11031610|NCT01212172|FG001|Participant Flow|LightSheer Duet 810 nm Diode Laser|"Soprano and LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
11031611|NCT01212172|OG000|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
11031612|NCT01212172|OG001|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
11031613|NCT01212172|OG000|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
11031614|NCT01212172|OG001|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
11031615|NCT01212172|EG000|Reported Event|Soprano/SHR 810 nm Diode Laser|"Alma Soprano/SHR VS Light Sheer Duet 810 nm Diode Lasers~Right Axilla or Lower Leg~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
11031616|NCT01212172|EG001|Reported Event|Light Sheer 810 nm Diode Laser|"Light Sheer 810 nm Diode Laser~Left Axilla or Lower Leg~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
11031617|NCT01212185|BG000|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
11031618|NCT01212185|BG001|Baseline|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
11031619|NCT01212185|BG002|Baseline|Total|Total of all reporting groups
11031620|NCT01212185|FG000|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 3 days"
11031621|NCT01212185|FG001|Participant Flow|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
11031622|NCT01212185|OG000|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
11031623|NCT01212185|OG001|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
11031624|NCT01212185|EG000|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
11031625|NCT01212185|EG001|Reported Event|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
11031626|NCT01212302|BG000|Baseline|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
11031627|NCT01212302|FG000|Participant Flow|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
11031628|NCT01212302|OG000|Outcome|Clopidogrel Low Response|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
11031629|NCT01212302|EG000|Reported Event|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
11031630|NCT01212445|BG000|Baseline|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
11031631|NCT01212445|BG001|Baseline|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031632|NCT01212445|BG002|Baseline|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031633|NCT01212445|BG003|Baseline|Total|Total of all reporting groups
11031634|NCT01212445|FG000|Participant Flow|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031635|NCT01212445|FG001|Participant Flow|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031636|NCT01212445|FG002|Participant Flow|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031637|NCT01212445|OG000|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031638|NCT01212445|OG001|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031639|NCT01212445|OG002|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031640|NCT01212445|OG000|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
11031641|NCT01212445|EG000|Reported Event|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031642|NCT01212445|EG001|Reported Event|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031643|NCT01212445|EG002|Reported Event|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
11031644|NCT01212471|BG000|Baseline|Bromfenac Ophthalmic Solution 0.06%|Bromfenac Ophthalmic Solution 0.06% twice a day
11031645|NCT01212471|BG001|Baseline|Bromfenac Ophthalmic Solution 0.03%|Bromfenac Ophthalmic Solution 0.03% twice a day
11031646|NCT01212471|BG002|Baseline|Placebo Comparator|"Placebo Comparator~Placebo Comparator: sterile ophthalmic solution"
11031647|NCT01212471|BG003|Baseline|Total|Total of all reporting groups
11031648|NCT01212471|FG000|Participant Flow|Bromfenac Ophthalmic Solution 0.06%|Bromfenac Ophthalmic Solution 0.06% twice a day
11031649|NCT01212471|FG001|Participant Flow|Bromfenac Ophthalmic Solution 0.03%|Bromfenac Ophthalmic Solution 0.03% twice a day
11031650|NCT01212471|FG002|Participant Flow|Placebo Comparator|"Placebo Comparator~Placebo Comparator: sterile ophthalmic solution"
11031651|NCT01212471|OG000|Outcome|Bromfenac Ophthalmic Solution 0.06%|Bromfenac Ophthalmic Solution 0.06% twice a day
11031652|NCT01212471|OG001|Outcome|Bromfenac Ophthalmic Solution 0.03%|Bromfenac Ophthalmic Solution 0.03% twice a day
11031653|NCT01212471|OG002|Outcome|Placebo Comparator|"Placebo Comparator~Placebo Comparator: sterile ophthalmic solution"
11031654|NCT01212471|EG000|Reported Event|Bromfenac Ophthalmic Solution 0.06%|Bromfenac Ophthalmic Solution 0.06% twice a day
11031655|NCT01212471|EG001|Reported Event|Bromfenac Ophthalmic Solution 0.03%|Bromfenac Ophthalmic Solution 0.03% twice a day
11031656|NCT01212471|EG002|Reported Event|Placebo Comparator|"Placebo Comparator~Placebo Comparator: sterile ophthalmic solution"
11031657|NCT01212484|BG000|Baseline|All Study Subjects|
11031658|NCT01212484|FG000|Participant Flow|Placebo (First), Carbidopa (Second)|Subjects will be given placebo first (4 weeks), followed by carbidopa (4 weeks).
11031659|NCT01212484|FG001|Participant Flow|Carbidopa (First), Placebo (Second)|Subjects will be given Carbidopa for a 4 week period followed by placebo for a 4 week period.
11031660|NCT01212484|OG000|Outcome|Carbidopa|
11031661|NCT01212484|OG001|Outcome|Placebo|
11031662|NCT01212484|EG000|Reported Event|Carbidopa|"carbidopa~Carbidopa : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
11031663|NCT01212484|EG001|Reported Event|Placebo|"Placebo~Placebo : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
11031664|NCT01212588|BG000|Baseline|Mifepristone|"Mifepristone 600mg once daily x 7 days~mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days"
11031665|NCT01212588|BG001|Baseline|Placebo|"Matching placebo tablets one daily~Placebo: 3 tablets once daily for seven days"
11031666|NCT01212588|BG002|Baseline|Total|Total of all reporting groups
11031667|NCT01212588|FG000|Participant Flow|Mifepristone|"Mifepristone 600mg once daily x 7 days~mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days"
11031668|NCT01212588|FG001|Participant Flow|Placebo|"Matching placebo tablets one daily~Placebo: 3 tablets once daily for seven days"
11031669|NCT01212588|OG000|Outcome|Mifepristone|"Mifepristone 600mg once daily x 7 days~mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days"
11031670|NCT01212588|OG001|Outcome|Placebo|"Matching placebo tablets one daily~Placebo: 3 tablets once daily for seven days"
11031671|NCT01212588|EG000|Reported Event|Mifepristone|"Mifepristone 600mg once daily x 7 days~mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days"
11031672|NCT01212588|EG001|Reported Event|Placebo|"Matching placebo tablets one daily~Placebo: 3 tablets once daily for seven days"
11031673|NCT01212627|BG000|Baseline|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
11031674|NCT01212627|FG000|Participant Flow|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
11031675|NCT01212627|OG000|Outcome|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
11031676|NCT01212627|EG000|Reported Event|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
11031677|NCT01212744|BG000|Baseline|rAvPAL-PEG|rAvPAL-PEG in varying doses
11031678|NCT01212744|FG000|Participant Flow|rAvPAL-PEG|"rAvPAL-PEG in varying doses~rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day"
11031679|NCT01212744|OG000|Outcome|rAvPAL-PEG|"rAvPAL-PEG in varying doses~rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day"
11031680|NCT01212744|OG000|Outcome|Total|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
11031681|NCT01212744|OG000|Outcome|Total|rAvPAL-PEG in all doses.
11031682|NCT01212744|EG000|Reported Event|rAvPAL-PEG|rAvPAL-PEG in varying doses
11031683|NCT01212757|BG000|Baseline|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
11031684|NCT01212757|BG001|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
11031685|NCT01212757|BG002|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
11031686|NCT01212757|BG003|Baseline|Total|Total of all reporting groups
11031687|NCT01212757|FG000|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily (BID) in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
11031688|NCT01212757|FG001|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
11031689|NCT01212757|FG002|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
11031690|NCT01212757|FG003|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to placebo twice daily in the 24-week placebo-controlled phase were re-randomized due to early escape (EE) at Week 16 and began receiving 20 mg apremilast tablets twice a day in the active treatment phase.
11031691|NCT01212757|FG004|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily in the 24-week placebo-controlled phase were re-randomized at Week 24 (XO) to 20 mg apremilast tablets twice daily in the active treatment phase.
11031692|NCT01212757|FG005|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to placebo twice daily in the 24-week placebo controlled phase were re-randomized due to early escape (EE) at Week 16 to 30 mg apremilast tablets twice daily in the active-treatment phase.
11031693|NCT01212757|FG006|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to placebo twice daily in the 24-week placebo-controlled phase were re-randomized at Week 24 to 30 mg apremilast tablets twice daily in the active treatment phase.
11031694|NCT01212757|FG007|Participant Flow|Placebo/Apremilast 20 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets twice daily during the placebo controlled phase were re-randomized to 20 mg apremilast twice daily at Week 16 or Week 24 and continued receiving apremilast 20 mg twice daily in the active treatment / long-term safety phase. (After 30 mg apremilast twice daily was identified as the optimal dose, all participants receiving 20 mg apremilast twice daily were switched to the 30 mg apremilast twice daily dose).
11031695|NCT01212757|FG008|Participant Flow|Placebo/Apremilast 30 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets twice daily during the placebo controlled phase were re-randomized to apremilast 30 mg tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 30 mg twice daily in the active treatment / long-term safety phase.
11031696|NCT01212757|OG000|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
11031697|NCT01212757|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
11031698|NCT01212757|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
11031699|NCT01212757|OG000|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
11031700|NCT01212757|OG001|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
11031701|NCT01212757|OG002|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
11031702|NCT01212757|OG003|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
11031703|NCT01212757|OG000|Outcome|Apremilast 20 mg (Pre-switch)|Participants who received apremilast 20 mg BID regardless of when the apremilast exposure started (at week 0, 16 and 24). Only the TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.
11031704|NCT01212757|OG001|Outcome|Apremilast 20 mg/30 mg (Post-switch)|Participants who switched from apremilast 20 mg BID to apremilast 30 mg BID. Only the TEAEs that occurred during APR 30 mg BID treatment were included.
11031705|NCT01212757|OG002|Outcome|Apremilast 30 mg BID|Participants who received apremilast 30 mg twice daily regardless of when the apremilast-exposure started (at Weeks 0, 16, or 24).
11031706|NCT01212757|EG000|Reported Event|Weeks 0-24: Placebo (Placebo-Controlled Phase)|Participants received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
11031707|NCT01212757|EG001|Reported Event|Weeks 0-24: Apremilast 20 mg (Placebo- Controlled Phase)|Participants received 20 mg apremilast tablets PO BID during the 24-week placebo-controlled phase.
11031708|NCT01212757|EG002|Reported Event|Weeks 0-24: Apremilast 30 mg (Placebo- Controlled Phase)|Participants received 30 mg apremilast tablets PO BID during the 24-week placebo-controlled phase.
11031709|NCT01212757|EG003|Reported Event|APR Exposure Period Up to 5 Years: APR 20 mg|Participants who received apremilast 20 mg tablets twice daily regardless of when the apremilast exposure started (at Week 0, 16 or 24). Only the TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.
11031710|NCT01212757|EG004|Reported Event|APR Exposure Period Up to 5 Years: APR 20mg/30 mg|Participants who switched from apremilast 20 mg BID to apremilast 30 mg BID. Only the TEAEs that occurred during APR 30 mg BID treatment were included.
11031711|NCT01212757|EG005|Reported Event|APR Exposure Period Up to 5 Years: APR 30 mg|Participants who received 30 mg apremilast twice daily regardless of when their apremilast-exposure started (at Weeks 0, 16, or 24).
11031712|NCT01212770|BG000|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
11031713|NCT01212770|BG001|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
11031714|NCT01212770|BG002|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
11031715|NCT01212770|BG003|Baseline|Total|Total of all reporting groups
11031716|NCT01212770|FG000|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily (BID) in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
11031717|NCT01212770|FG001|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase continued receiving 20 mg apremilast tablets twice daily in the active treatment / long-term safety phase (LTSP).
11031718|NCT01212770|FG002|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
11031719|NCT01212770|FG003|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to placebo twice daily were re-randomized due to early escape (EE) at Week 16 and began to receive 20 mg apremilast twice a day in the active treatment phase.
11031720|NCT01212770|FG004|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily were re-randomized at Week 24 (XO) to 20 mg apremilast tablets twice daily in the active treatment phase.
11031721|NCT01212770|FG005|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to placebo twice daily were re-randomized due to early escape (EE) at Week 16 began receiving 30 mg apremilast tablets twice daily in the active treatment phase.
11031722|NCT01212770|FG006|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to placebo twice daily were re-randomized at Week 24 to 30 mg apremilast twice daily in the active treatment phase.
11031723|NCT01212770|FG007|Participant Flow|Placebo/Apremilast 20 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets twice daily during the 24-week placebo-controlled phase were re-randomized to 20 mg apremilast tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 20 mg tablets twice daily in active treatment / long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose).
11031724|NCT01212770|FG008|Participant Flow|Placebo/Apremilast 30 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets BID during the 24-week placebo-controlled phase were re-randomized to apremilast 30 mg tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 30 mg tablets twice daily in the active treatment / long-term safety phase.
11031725|NCT01212770|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
11031726|NCT01212770|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
11031727|NCT01212770|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
11031728|NCT01212770|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
11031729|NCT01212770|OG000|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
11031730|NCT01212770|OG001|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
11031731|NCT01212770|OG002|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
11031732|NCT01212770|OG003|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
11031733|NCT01212770|OG000|Outcome|Placebo|Participants received placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were rerandomized to either 20 mg or 30 mg apremilast twice daily (early escape).
11031734|NCT01212770|OG001|Outcome|Apremilast 20 mg|Participants who received 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
11031735|NCT01212770|OG002|Outcome|Apremilast 30 mg|Participants who received 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
11031736|NCT01212770|OG000|Outcome|Apremilast 20 mg (Pre-switch)|Participants who received apremilast 20 mg twice daily regardless of when the apremilast exposure started (at Week 0, 16, or 24). Only the TEAEs that occurred during apremilast 20 mg BID were counted.
11031737|NCT01212770|OG001|Outcome|Apremilast 20/30 mg (Post-switch)|Participants who switched from apremilast 20 mg BID to apremilast 30 mg BID. Only the TEAEs that occurred during APR 30 mg BID treatment were included.
11031738|NCT01212770|OG002|Outcome|Apremilast 30 mg|Participants who received apremilast 30 mg twice daily regardless of when the apremilast-exposure started (at Week 0, 16, or 24).
11031739|NCT01212770|EG000|Reported Event|Weeks 0-24: Placebo (Placebo-Controlled Phase)|Participants received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
11031740|NCT01212770|EG001|Reported Event|Weeks 0-24: Apremilast 20 mg (Placebo- Controlled Phase)|Participants received 20 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.
11031741|NCT01212770|EG002|Reported Event|Weeks 0-24: Apremilast 30 mg (Placebo- Controlled Phase)|Participants received 30 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.
11031742|NCT01212770|EG003|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 20 mg|Participants who received apremilast 20 mg twice daily regardless of when the apremilast exposure started (at Week 0, 16 or 24). Only TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.
11031743|NCT01212770|EG004|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 20mg/30 mg|Participants who switched from apremilast 20 mg twice daily to apremilast 30 mg BID. Only the TEAEs that occurred during apremilast 30 mg twice daily treatment were included.
11031744|NCT01212770|EG005|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 30 mg|Participants who received apremilast 30 mg twice daily throughout the study regardless of when the apremilast-exposure started (at Week 0, 16, or 24).
11031745|NCT01212874|BG000|Baseline|Nitroglycerin|"nitroglycerin infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass~nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery."
11031746|NCT01212874|BG001|Baseline|Esmolol|"esmolol infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass~esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension."
11031747|NCT01212874|BG002|Baseline|Total|Total of all reporting groups
11031748|NCT01212874|FG000|Participant Flow|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
11031749|NCT01212874|FG001|Participant Flow|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
11031750|NCT01212874|OG000|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
11031751|NCT01212874|OG001|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
11031752|NCT01212874|EG000|Reported Event|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
11031753|NCT01212874|EG001|Reported Event|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
11031754|NCT01212900|BG000|Baseline|Imaging|Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
11031755|NCT01212900|BG001|Baseline|Standard|Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
11031756|NCT01212900|BG002|Baseline|Total|Total of all reporting groups
11031757|NCT01212900|FG000|Participant Flow|Imaging|Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
11031758|NCT01212900|FG001|Participant Flow|Standard|Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
11031759|NCT01212900|OG000|Outcome|Imaging|Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
11031760|NCT01212900|OG001|Outcome|Standard|Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
11031761|NCT01212900|EG000|Reported Event|Imaging|Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
11031762|NCT01212900|EG001|Reported Event|Standard|Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
11031763|NCT01212952|BG000|Baseline|Phase 1; Dose Level 1|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11031764|NCT01212952|BG001|Baseline|Phase 1; Dose Level 2|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11031765|NCT01212952|BG002|Baseline|Phase 2; Dose Level 2|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11031766|NCT01212952|BG003|Baseline|Total|Total of all reporting groups
11031767|NCT01212952|FG000|Participant Flow|Phase 1 Dose Level 1|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
11031768|NCT01212952|FG001|Participant Flow|Phase 1 Dose Level 2|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
11031769|NCT01212952|FG002|Participant Flow|Phase 2 Dose Level 2|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
11031770|NCT01212952|OG000|Outcome|Phase 1 Dose Level 1|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
11031771|NCT01212952|OG001|Outcome|Phase 1 Dose Level 2|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
11031772|NCT01212952|OG000|Outcome|Phase I - Dose Level 1|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
11031773|NCT01212952|OG001|Outcome|Phase I - Dose Level 2|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
11031774|NCT01212952|OG002|Outcome|Phase II|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
11031775|NCT01212952|EG000|Reported Event|Phase 1; Dose Level 1|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11031776|NCT01212952|EG001|Reported Event|Phase 1; Dose Level 2|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11031777|NCT01212952|EG002|Reported Event|Phase 2; Dose Level 2|Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11031778|NCT01212991|BG000|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11031779|NCT01212991|BG001|Baseline|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
11349042|NCT04128293|FG003|Participant Flow|Sequence 4 - Treatment DCBA|Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
11031780|NCT01212991|BG002|Baseline|Total|Total of all reporting groups
11031781|NCT01212991|FG000|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11031782|NCT01212991|FG001|Participant Flow|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
11031783|NCT01212991|FG002|Participant Flow|Placebo Participants Crossover to Enzalutamide|Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11031784|NCT01212991|OG000|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11031785|NCT01212991|OG001|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
11031786|NCT01212991|OG002|Outcome|Placebo Participants Crossover to Enzalutamide|Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11031787|NCT01212991|EG000|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11031788|NCT01212991|EG001|Reported Event|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
11031789|NCT01212991|EG002|Reported Event|Placebo Participants Crossover to Enzalutamide|Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
11031790|NCT01213043|BG000|Baseline|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
11031791|NCT01213043|BG001|Baseline|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
11031792|NCT01213043|BG002|Baseline|Total|Total of all reporting groups
11031793|NCT01213043|FG000|Participant Flow|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
11031794|NCT01213043|FG001|Participant Flow|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
11031795|NCT01213043|OG000|Outcome|60 mg/kg Prolastin-C|
11031796|NCT01213043|OG001|Outcome|120 mg/kg Prolastin-C|
11031797|NCT01213043|EG000|Reported Event|60 mg/kg Prolastin-C|
11031798|NCT01213043|EG001|Reported Event|120 mg/kg Prolastin-C|
11031799|NCT01213082|BG000|Baseline|24GyE + Anti-VEGF|24GyE proton and Anti-VEGF: 24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
11031800|NCT01213082|BG001|Baseline|16GyE + Anti-VEGF|16GyE and anti-VEGF: 16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
11031801|NCT01213082|BG002|Baseline|Sham Irradiation + Anti-VEGF|Sham Irradiation and anti-VEGF: 2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
11031802|NCT01213082|BG003|Baseline|Total|Total of all reporting groups
11031803|NCT01213082|FG000|Participant Flow|24GyE + Anti-VEGF|24GyE proton and Anti-VEGF: 24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
11031804|NCT01213082|FG001|Participant Flow|16GyE + Anti-VEGF|16GyE and anti-VEGF: 16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
11031805|NCT01213082|FG002|Participant Flow|Sham Irradiation + Anti-VEGF|Sham Irradiation and anti-VEGF: 2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
11031806|NCT01213082|OG000|Outcome|24GyE PBT|intravitreal anti-VEGF combined with 24GyE PBT for exudative AMD
11031807|NCT01213082|OG001|Outcome|16GyE PBT|intravitreal anti-VEGF combined with 16GyE PBT for exudative AMD
11031808|NCT01213082|OG002|Outcome|Sham Radiation|intravitreal anti-VEGF combined with sham PBT for exudative AMD
10887041|NCT00498550|FG001|Participant Flow|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
11031809|NCT01213082|EG000|Reported Event|24GyE + Anti-VEGF|24GyE proton and Anti-VEGF: 24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
11031810|NCT01213082|EG001|Reported Event|16GyE + Anti-VEGF|16GyE and anti-VEGF: 16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
11031811|NCT01213082|EG002|Reported Event|Sham Irradiation + Anti-VEGF|Sham Irradiation and anti-VEGF: 2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
11031812|NCT01213173|BG000|Baseline|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
11031813|NCT01213173|BG001|Baseline|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
11031814|NCT01213173|BG002|Baseline|Total|Total of all reporting groups
11031815|NCT01213173|FG000|Participant Flow|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
11031816|NCT01213173|FG001|Participant Flow|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
11031817|NCT01213173|OG000|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
11031818|NCT01213173|OG001|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
11031819|NCT01213173|EG000|Reported Event|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
11031820|NCT01213173|EG001|Reported Event|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
11031821|NCT01213199|BG000|Baseline|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
11031822|NCT01213199|FG000|Participant Flow|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
11031823|NCT01213199|OG000|Outcome|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
11031824|NCT01213199|EG000|Reported Event|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
11031825|NCT01213251|BG000|Baseline|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
11031826|NCT01213251|BG001|Baseline|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
11031827|NCT01213251|BG002|Baseline|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
11031828|NCT01213251|BG003|Baseline|Total|Total of all reporting groups
11031829|NCT01213251|FG000|Participant Flow|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
10887042|NCT00498550|OG000|Outcome|Clozapine|Clozapine, Clozaril
10887043|NCT00498550|OG001|Outcome|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
10887044|NCT00498550|EG000|Reported Event|Clozapine|Clozapine, Clozaril
10887045|NCT00498550|EG001|Reported Event|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
11031830|NCT01213251|FG001|Participant Flow|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
11031831|NCT01213251|FG002|Participant Flow|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
11031832|NCT01213251|OG000|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
11031833|NCT01213251|OG001|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
11031834|NCT01213251|OG000|Outcome|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
11031835|NCT01213251|OG001|Outcome|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
11031836|NCT01213251|OG000|Outcome|Single Site Pacing|Subjects randomized to the group that were successfully implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
11031837|NCT01213251|OG001|Outcome|Dual Site Pacing|Subjects randomized to the group that were successfully be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
11031838|NCT01213251|OG002|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
11031839|NCT01213251|OG000|Outcome|All Subjects|All subjects randomized in the study (either control, single pacing or dual pacing). For the patients randomized to single or dual site, only patients with successful implant are included.
11031840|NCT01213251|EG000|Reported Event|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
11031841|NCT01213251|EG001|Reported Event|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
11031842|NCT01213251|EG002|Reported Event|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
11031843|NCT01213264|BG000|Baseline|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
10887046|NCT00498602|BG000|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11031844|NCT01213264|BG001|Baseline|Sugammadex|Participants administered sugammadex for NMB reversal
11031845|NCT01213264|BG002|Baseline|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
11031846|NCT01213264|BG003|Baseline|Total|Total of all reporting groups
10887047|NCT00498602|BG001|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11031847|NCT01213264|FG000|Participant Flow|Spontaneous Reversal|Participants whose reversal from neuromuscular blockade (NMB) was spontaneous (no reversal agent used)
11031848|NCT01213264|FG001|Participant Flow|Sugammadex|Participants administered sugammadex for NMB reversal
11031849|NCT01213264|FG002|Participant Flow|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
11031850|NCT01213264|OG000|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
11031851|NCT01213264|OG001|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
11031852|NCT01213264|OG002|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
11031853|NCT01213264|OG000|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
11031854|NCT01213264|OG000|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
11031855|NCT01213264|OG001|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
11031856|NCT01213264|EG000|Reported Event|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
11031857|NCT01213264|EG001|Reported Event|Sugammadex|Participants administered sugammadex for NMB reversal
11031858|NCT01213264|EG002|Reported Event|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
11031859|NCT01213316|BG000|Baseline|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
11031860|NCT01213316|FG000|Participant Flow|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
11031861|NCT01213316|OG000|Outcome|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
11031862|NCT01213316|OG000|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
11031863|NCT01213316|OG000|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
11031864|NCT01213316|EG000|Reported Event|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
11031865|NCT01213316|EG001|Reported Event|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
11031866|NCT01213316|EG002|Reported Event|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
11031867|NCT01213472|BG000|Baseline|NY-ESO 1 Group|Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
11031868|NCT01213472|FG000|Participant Flow|NY-ESO 1 Group|Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
11031869|NCT01213472|OG000|Outcome|NY-ESO 1 Group|Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
11031870|NCT01213472|EG000|Reported Event|NY-ESO 1 Group|Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
11031871|NCT01213524|BG000|Baseline|Smokers With Schizophrenia|
11031872|NCT01213524|BG001|Baseline|Non-Psychiatric Controls|Smokers without current psychiatric illness
11031873|NCT01213524|BG002|Baseline|Total|Total of all reporting groups
11031874|NCT01213524|FG000|Participant Flow|VLNC + NIC|"Within-subjects study with 5 conditions that participants underwent in counter-balanced order:~Transdermal nicotine replacement + sensorimotor replacement (denicotinized cigarettes)~Transdermal nicotine replacement + no sensorimotor replacement~Placebo patches + sensorimotor replacement~Placebo patches + no sensorimotor replacement~Usual brand cigarettes"
11031875|NCT01213524|OG000|Outcome|Very Low Nicotine Content Cigarettes + Nicotine Replacement|5-hr very low nicotine cigarettes + 42 mg nicotine replacement
10887048|NCT00498602|BG002|Baseline|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11031876|NCT01213524|OG001|Outcome|Very Low Nicotine Content Cigarettes + Placebo|5-hr very low nicotine cigarettes + placebo patches
11031877|NCT01213524|OG002|Outcome|No Cigarettes + Nicotine Replacement|5-hr 42 mg nicotine replacement only
11031878|NCT01213524|OG003|Outcome|No Cigarettes + Placebo|5-hr placebo patches only
11031879|NCT01213524|OG004|Outcome|Usual Brand Cigarettes|5-hr use of usual-brand cigarettes
11031880|NCT01213524|OG001|Outcome|Very Low Nicotine Content Cigarettes + Placebo|5-hr very low nicotine cigarettes plus placebo patches
11031881|NCT01213524|OG004|Outcome|Usual Brand Cigarettes|5-hr use of usual brand cigarettes
11031882|NCT01213524|EG000|Reported Event|Smokers With Schizophrenia|
11031883|NCT01213524|EG001|Reported Event|Non-Psychiatric Controls|Smokers without current psychiatric illness
11031884|NCT01213576|BG000|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Annual|Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year
11031885|NCT01213576|BG001|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Annual|Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year
11031886|NCT01213576|BG002|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Biannual|Albendazole 400mg and ivermectin 200mcg/kg given twice a year
11031887|NCT01213576|BG003|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual|Albendazole 800mg and ivermectin 400mcg/kg given twice a year
11031888|NCT01213576|BG004|Baseline|Total|Total of all reporting groups
11031889|NCT01213576|FG000|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
11031890|NCT01213576|FG001|Participant Flow|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
11031891|NCT01213576|FG002|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
11031892|NCT01213576|FG003|Participant Flow|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
11031893|NCT01213576|OG000|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
11031894|NCT01213576|OG001|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
11031895|NCT01213576|OG002|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
11031896|NCT01213576|OG003|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
11031897|NCT01213576|EG000|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
11031898|NCT01213576|EG001|Reported Event|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
11031899|NCT01213576|EG002|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
11031900|NCT01213576|EG003|Reported Event|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
11031901|NCT01213589|BG000|Baseline|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
11031902|NCT01213589|BG001|Baseline|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
11031903|NCT01213589|BG002|Baseline|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
11031904|NCT01213589|BG003|Baseline|Total|Total of all reporting groups
11031905|NCT01213589|FG000|Participant Flow|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
11031906|NCT01213589|FG001|Participant Flow|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
11031907|NCT01213589|FG002|Participant Flow|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
11031908|NCT01213589|OG000|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
11031909|NCT01213589|OG001|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
11031910|NCT01213589|OG002|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
11031911|NCT01213589|EG000|Reported Event|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
11225842|NCT02370537|FG000|Participant Flow|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially triglycerides (TGs) and faecal elastase-1 concentration (FEC) as a measure of pancreatic exocrine function in the study population. Patients in the Low FEC group were determined to have FEC levels <100 microgram per gram (mcg/g). No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
11225843|NCT02370537|FG001|Participant Flow|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
11225844|NCT02370537|FG002|Participant Flow|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
11225845|NCT02370537|OG000|Outcome|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels <100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
11225846|NCT02370537|OG001|Outcome|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
11031912|NCT01213589|EG001|Reported Event|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
11031913|NCT01213589|EG002|Reported Event|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
11031914|NCT01213706|BG000|Baseline|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.~Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
11031915|NCT01213706|FG000|Participant Flow|SHAM WBPA Then WBPA|
11031916|NCT01213706|OG000|Outcome|WBPA|Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
11031917|NCT01213706|OG001|Outcome|Sham WBPA|Subjects will be resting on the platform without any WBPA.
11225847|NCT02370537|OG002|Outcome|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
11225848|NCT02370537|OG000|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
11225849|NCT02370537|OG001|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
11031918|NCT01213706|EG000|Reported Event|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.~Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
11031919|NCT01213706|EG001|Reported Event|Sham WBPA|"The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.~Sham WBPA: The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge."
11031920|NCT01213823|BG000|Baseline|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
11031921|NCT01213823|BG001|Baseline|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
11031922|NCT01213823|BG002|Baseline|Total|Total of all reporting groups
11031923|NCT01213823|FG000|Participant Flow|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
11031924|NCT01213823|FG001|Participant Flow|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
11031925|NCT01213823|OG000|Outcome|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
11031926|NCT01213823|OG001|Outcome|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
11031927|NCT01213823|EG000|Reported Event|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
11031928|NCT01213823|EG001|Reported Event|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
11031929|NCT01213836|BG000|Baseline|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
11031930|NCT01213836|BG001|Baseline|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
11031931|NCT01213836|BG002|Baseline|Total|Total of all reporting groups
11031932|NCT01213836|FG000|Participant Flow|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
11031933|NCT01213836|FG001|Participant Flow|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
11031934|NCT01213836|OG000|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
11031935|NCT01213836|OG001|Outcome|Seroquel IR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
11031936|NCT01213836|OG001|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
11031937|NCT01213836|OG000|Outcome|Seroquel XR|Patients treated with at least one dose of Seroquel XR
11031938|NCT01213836|OG001|Outcome|Seroquel IR|Patients treated with at least one dose of Seroquel IR
11031939|NCT01213836|EG000|Reported Event|Seroquel XR|Patients treated with at least one dose of Seroquel XR
11031940|NCT01213836|EG001|Reported Event|Seroquel IR|Patients treated with at least one dose of Seroquel IR
11031941|NCT01213940|BG000|Baseline|Baratric Surgery|"surgery vs.weight loss program 6 months prior to bariatric surgery~bariatric surgery: bariatric surgery for weight loss"
11031942|NCT01213940|BG001|Baseline|Pre-bariatric Weight Loss Program|"weight loss program prior to bariatric surgery~pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program"
11031943|NCT01213940|BG002|Baseline|Total|Total of all reporting groups
11031944|NCT01213940|FG000|Participant Flow|Baratric Surgery|"surgery vs.weight loss program 6 months prior to bariatric surgery~bariatric surgery: bariatric surgery for weight loss"
11031945|NCT01213940|FG001|Participant Flow|Pre-bariatric Weight Loss Program|"weight loss program prior to bariatric surgery~pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program"
11031946|NCT01213940|OG000|Outcome|Bariatric Surgery|surgery vs, weight loss program 6 months prior to bariatric surgery
11031947|NCT01213940|OG001|Outcome|Pre-bariatric Weight Loss Program|weight loss program prior to bariatric surgery
11031948|NCT01213940|EG000|Reported Event|Baratric Surgery|"surgery vs.weight loss program 6 months prior to bariatric surgery~bariatric surgery: bariatric surgery for weight loss"
11031949|NCT01213940|EG001|Reported Event|Pre-bariatric Weight Loss Program|"weight loss program prior to bariatric surgery~pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program"
11031950|NCT01213966|BG000|Baseline|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
11031951|NCT01213966|BG001|Baseline|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
11031952|NCT01213966|BG002|Baseline|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
11031953|NCT01213966|BG003|Baseline|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
11031954|NCT01213966|BG004|Baseline|Total|Total of all reporting groups
11031955|NCT01213966|FG000|Participant Flow|800 mg OZ439 po Single Dose|Cohort 1 received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients was made following a study cohort review
11031956|NCT01213966|FG001|Participant Flow|400 mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
11031957|NCT01213966|FG002|Participant Flow|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
11031958|NCT01213966|FG003|Participant Flow|1200 mg OZ439 po Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.received single dose
11031959|NCT01213966|OG000|Outcome|800 mg OZ439 po Single Dose|The first cohort received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients with either P. falciparum or P. vivax malaria, was made following a study cohort review of the safety data, drug exposure levels, and the PRR over 24 hours after the investigational product administration (PRR24) obtained from the previous cohort.
11031960|NCT01213966|OG001|Outcome|400 mg OZ439 p.o. Single Dose|After review of the data from Cohort 1 (800 mg), patients in Cohort 2 received a single dose of 400 mg OZ439.
11031961|NCT01213966|OG002|Outcome|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg) and data from Cohort 2 (400 mg), patients in Cohort 3 received a single dose of 200 mg OZ439.
11031962|NCT01213966|OG003|Outcome|1200 mg OZ439 po Single Dose|"Ultimately, after review of the data from Cohort 1 (800 mg), from Cohort 2 (400 mg), and Cohort 3 (200 mg), patients in Cohort 4 received a single dose of 1200 mg OZ439.~It was decided not to proceed with a fifth cohort and no further patients were enrolled."
11031963|NCT01213966|EG000|Reported Event|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
11031964|NCT01213966|EG001|Reported Event|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
11031965|NCT01213966|EG002|Reported Event|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
11031966|NCT01213966|EG003|Reported Event|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
11031967|NCT01214044|BG000|Baseline|Study Drug|"Subjects will have a total of 12 visits to Oregon Clinical & Translational Research Institute at Oregon Health & Science University over the 14-16 weeks of study. An initial screening visit will determine eligibility. Subjects who meet criteria and agree to participate will then stop taking their current antidepressant medication (if applicable), during which time the study doctor and staff will conduct weekly mood assessments to ensure safety. Subjects will then have a study initiation/materials visit followed by 9 visits during treatment with placebo or escitalopram. A final post-study follow-up safety visit will be scheduled at the end of treatment.~Placebo/escitalopram: Subjects will first complete a one week, single-blind placebo lead in phase. Subjects will then receive escitalopram for 8 weeks. Subjects will receive 10 mg/day for the first 2 weeks of active treatment, and then 20 mg/day for the remaining 6 weeks of treatment. Medication will be dispensed weekly."
11031968|NCT01214044|FG000|Participant Flow|Study Drug|"Subjects will have a total of 12 visits to Oregon Clinical & Translational Research Institute at Oregon Health & Science University over the 14-16 weeks of study. Subjects will first undergo an initial screening visit to determine eligibility. Subjects who meet criteria will then stop taking their current antidepressant medication (if applicable), during which time the study doctor and staff will conduct weekly mood assessments to ensure safety. Subjects will then have a study initiation/materials visit followed by 9 visits during treatment with placebo or escitalopram. A final post-study follow-up safety visit will be scheduled at the end of treatment.~placebo/escitalopram: Subjects will first complete a one week, single-blind placebo lead in phase. Subjects will then receive escitalopram for 8 weeks. Subjects will receive 10 mg/day for the first 2 weeks of active treatment, and then 20 mg/day for the remaining 6 weeks of treatment. Medication will be dispensed on a weekly basis."
11349043|NCT04128293|OG000|Outcome|Treatment A- GSK3640254 200 mg Capsules (Fed)|Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
11031969|NCT01214044|OG000|Outcome|Study Drug|"Subjects will have a total of 12 visits to Oregon Clinical & Translational Research Institute at Oregon Health & Science University over the 14-16 weeks of study. An initial screening visit will determine eligibility. Subjects who meet criteria and agree to participate will then stop taking their current antidepressant medication (if applicable), during which time the study doctor and staff will conduct weekly mood assessments to ensure safety. Subjects will then have a study initiation/materials visit followed by 9 visits during treatment with placebo or escitalopram. A final post-study follow-up safety visit will be scheduled at the end of treatment.~Placebo/escitalopram: Subjects will first complete a one week, single-blind placebo lead in phase. Subjects will then receive escitalopram for 8 weeks. Subjects will receive 10 mg/day for the first 2 weeks of active treatment, and then 20 mg/day for the remaining 6 weeks of treatment. Medication will be dispensed weekly."
11031970|NCT01214044|OG000|Outcome|Study Drug|"Subjects will have a total of 12 visits to Oregon Clinical & Translational Research Institute at Oregon Health & Science University over the 14-16 weeks of study. An initial screening visit will determine eligibility. Subjects who meet criteria and agree to participate will then stop taking their current antidepressant medication (if applicable), during which time the study doctor and staff will conduct weekly mood assessments to ensure safety. Subjects will then have a study initiation/materials visit followed by 9 visits during treatment with placebo or escitalopram. A final post-study follow-up safety visit will be scheduled at the end of treatment.~placebo/escitalopram: Subjects will first complete a one week, single-blind placebo lead in phase. Subjects will then receive escitalopram for 8 weeks. Subjects will receive 10 mg/day for the first 2 weeks of active treatment, and then 20 mg/day for the remaining 6 weeks of treatment. Medication will be dispensed on a weekly basis."
11031971|NCT01214044|EG000|Reported Event|Visit 1: Screening & Consent, Washout|Subjects will have a total of 12 visits to Oregon Clinical & Translational Research Institute at Oregon Health & Science University over the 14-16 weeks of study. An initial screening visit will determine eligibility. Subjects who meet criteria and agree to participate will then stop taking their current antidepressant medication (if applicable), during which time the study doctor and staff will conduct weekly mood assessments to ensure safety.
11031972|NCT01214044|EG001|Reported Event|Visit 2: End Washout & Start Placebo|After completing the washout period, Subjects will then complete a one week, single-blind placebo lead in phase.
11031973|NCT01214044|EG002|Reported Event|Visits 3-5: Escitalopram 10 mg Daily|After the week of placebo, Subjects will then receive 10 mg/day of escitalpram for the first 2 weeks of active treatment.
11031974|NCT01214044|EG003|Reported Event|Visits 6-11: Escitalopram 20 mg Daily|After receiving 10 mg/day of escitalopram for 2 weeks, subjects will then receive escitalopram, 20 mg/day for the remaining 6 weeks of treatment.
11031975|NCT01214057|BG000|Baseline|Total Intravenous Anesthesia|"Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl~Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min."
11031976|NCT01214057|BG001|Baseline|Inhaled Anesthesia|"Inhaled anesthesia with sevoflurane and remifentanyl.~Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml."
11031977|NCT01214057|BG002|Baseline|Total|Total of all reporting groups
11031978|NCT01214057|FG000|Participant Flow|Total Intravenous Anesthesia|"Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl~Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min."
11031979|NCT01214057|FG001|Participant Flow|Inhaled Anesthesia|"Inhaled anesthesia with sevoflurane and remifentanyl.~Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml."
11066432|NCT01392378|FG001|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
11349044|NCT04128293|OG001|Outcome|Treatment B- GSK3640254 200 mg Tablet (Fed)|Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
11031980|NCT01214057|OG000|Outcome|Total Intravenous Anesthesia|"Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl~Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min."
11031981|NCT01214057|OG001|Outcome|Inhaled Anesthesia|"Inhaled anesthesia with sevoflurane and remifentanyl.~Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml."
11031982|NCT01214057|EG000|Reported Event|Total Intravenous Anesthesia|"Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl~Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min."
11031983|NCT01214057|EG001|Reported Event|Inhaled Anesthesia|"Inhaled anesthesia with sevoflurane and remifentanyl.~Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml."
11031984|NCT01214083|BG000|Baseline|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
11031985|NCT01214083|BG001|Baseline|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
11031986|NCT01214083|BG002|Baseline|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
11031987|NCT01214083|BG003|Baseline|Total|Total of all reporting groups
11031988|NCT01214083|FG000|Participant Flow|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
11031989|NCT01214083|FG001|Participant Flow|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
11031990|NCT01214083|FG002|Participant Flow|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
11031991|NCT01214083|OG000|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
11031992|NCT01214083|OG001|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
11031993|NCT01214083|OG002|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
11031994|NCT01214083|EG000|Reported Event|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
11031995|NCT01214083|EG001|Reported Event|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
11031996|NCT01214083|EG002|Reported Event|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
11031997|NCT01214109|BG000|Baseline|All Subjects|24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented are by overall treatment.
11031998|NCT01214109|FG000|Participant Flow|0.375 mg q.d.Extended Release (ER)|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11031999|NCT01214109|FG001|Participant Flow|0.125 mg t.i.d. Immediate Release (IR)|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
11032000|NCT01214109|FG002|Participant Flow|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11032001|NCT01214109|FG003|Participant Flow|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
11032002|NCT01214109|OG000|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11032003|NCT01214109|OG001|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
11032004|NCT01214109|OG002|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11032005|NCT01214109|OG003|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
11032006|NCT01214109|EG000|Reported Event|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11032007|NCT01214109|EG001|Reported Event|0.75 mg q.d. ER Up-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11032008|NCT01214109|EG002|Reported Event|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11032009|NCT01214109|EG003|Reported Event|0.75 mg q.d. ER Down-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11032010|NCT01214109|EG004|Reported Event|0.375 mg q.d.ER Down-titration|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
11032011|NCT01214109|EG005|Reported Event|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
11032012|NCT01214109|EG006|Reported Event|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
11032013|NCT01214161|BG000|Baseline|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
11032014|NCT01214161|BG001|Baseline|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
11032015|NCT01214161|BG002|Baseline|Total|Total of all reporting groups
11032016|NCT01214161|FG000|Participant Flow|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
11032017|NCT01214161|FG001|Participant Flow|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
11032018|NCT01214161|OG000|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
11032019|NCT01214161|OG001|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
11032020|NCT01214161|OG000|Outcome|Participants|The cohort of all 200 women having their IUD inserted.
11032021|NCT01214161|OG001|Outcome|Providers|The healthcare provider placing the IUD on that particular participant.
11032022|NCT01214161|EG000|Reported Event|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
11150229|NCT01876446|EG001|Reported Event|B: Chemo Sensitive|"Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.~Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Pegylated Irinotecan: Given IV~Pharmacological Study: Correlative studies"
11032023|NCT01214161|EG001|Reported Event|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
11032024|NCT01214174|BG000|Baseline|Dose 1|IBI-10090 513ug
11032025|NCT01214174|BG001|Baseline|Dose 2|IBI-10090 776ug
11032026|NCT01214174|BG002|Baseline|Dose 3|IBI-10090 1046ug
11032027|NCT01214174|BG003|Baseline|Total|Total of all reporting groups
11032028|NCT01214174|FG000|Participant Flow|Dose 1|IBI-10090 513ug
11032029|NCT01214174|FG001|Participant Flow|Dose 2|IBI-10090 776ug
11032030|NCT01214174|FG002|Participant Flow|Dose 3|IBI-10090 1046ug
11032031|NCT01214174|OG000|Outcome|Dose 1|IBI-10090 513ug
11032032|NCT01214174|OG001|Outcome|Dose 2|IBI-10090 776ug
11032033|NCT01214174|OG002|Outcome|Dose 3|IBI-10090 1046ug
11032034|NCT01214174|EG000|Reported Event|Dose 1|IBI-10090 513ug
11032035|NCT01214174|EG001|Reported Event|Dose 2|IBI-10090 776ug
11032036|NCT01214174|EG002|Reported Event|Dose 3|IBI-10090 1046ug
11032037|NCT01214187|BG000|Baseline|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
11032038|NCT01214187|BG001|Baseline|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
11032039|NCT01214187|BG002|Baseline|Total|Total of all reporting groups
11032040|NCT01214187|FG000|Participant Flow|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
11032041|NCT01214187|FG001|Participant Flow|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
11032042|NCT01214187|OG000|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
11032043|NCT01214187|OG001|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
11032044|NCT01214187|EG000|Reported Event|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
11032045|NCT01214187|EG001|Reported Event|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
11032046|NCT01214200|BG000|Baseline|High Intensity Non Invasive Pos.Pressure|The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
11032047|NCT01214200|FG000|Participant Flow|High Intensity Non Invasive Pos.Pressure|The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic Chronic Obstructive Pulmonary Diseased (COPD) participants that meet eligibility criteria will receive HINPPV for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O (centimeters of water); or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
11032048|NCT01214200|OG000|Outcome|High Intensity Non Invasive Pos.Pressure|The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
11032049|NCT01214200|OG000|Outcome|At Rest|All participants competed the modifed Borg scale at rest, prior to exercise.
11032050|NCT01214200|OG001|Outcome|After Exertion|All participants completed the modified Borg scale after exertion (6 minute walk test).
11032051|NCT01214200|EG000|Reported Event|High Intensity Non Invasive Pos.Pressure|The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
11032052|NCT01214239|BG000|Baseline|Placebo|Placebo
11032053|NCT01214239|BG001|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
11032054|NCT01214239|BG002|Baseline|Total|Total of all reporting groups
11032055|NCT01214239|FG000|Participant Flow|Placebo|Placebo
11032056|NCT01214239|FG001|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
11032057|NCT01214239|OG000|Outcome|Placebo|Placebo
11032058|NCT01214239|OG001|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
11032059|NCT01214239|EG000|Reported Event|Placebo|Placebo
11032060|NCT01214239|EG001|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
11032061|NCT01214252|BG000|Baseline|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
11032062|NCT01214252|FG000|Participant Flow|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
11032063|NCT01214252|OG000|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.~Permacol Surgical Implant: Permacol Surgical Implant"
11032064|NCT01214252|OG000|Outcome|Permacol Patients|"Total (confirmed or unconfrimed) hernia or hernia recurrence at the repair site by year (# and percentage).~Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms questionnaire but not confirmed by clinical assessment by a surgeon or medical chart review"
11032065|NCT01214252|EG000|Reported Event|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
11032066|NCT01214317|BG000|Baseline|Mitoxantrone and Plasmapheresis|plasmapheresis: 3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
11032067|NCT01214317|BG001|Baseline|Mitoxantrone|
11032068|NCT01214317|BG002|Baseline|Total|Total of all reporting groups
11032069|NCT01214317|FG000|Participant Flow|Mitoxantrone and Plasmapheresis|Monthly plasmapheresis (plasma exchange machine: Haemonetics, model TCS2, USA) 25 ml/kg for 5 cycles, with replacement of 0.9% saline and 5% human serum albumin followed by monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) at the end of each plasmapheresis course for three successive months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
11032070|NCT01214317|FG001|Participant Flow|Mitoxantrone|Monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
11032071|NCT01214317|OG000|Outcome|Mitoxantrone and Plasmapheresis|Monthly Plasmapheresis (plasma exchange machine: Haemonetics, model TCS2, USA) 25 ml/kg for 5 cycles, with replacement of 0.9% saline and 5% human serum albumin followed by monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) at the end of each Plasmapheresis course for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
11032072|NCT01214317|OG001|Outcome|Mitoxantrone|Monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
11032073|NCT01214317|OG000|Outcome|Mitoxantrone and Plasmapheresis|plasmapheresis: 3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
11032074|NCT01214317|OG001|Outcome|Mitoxantrone|
11032075|NCT01214317|EG000|Reported Event|Mitoxantrone and Plasmapheresis|plasmapheresis: 3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
11032076|NCT01214317|EG001|Reported Event|Mitoxantrone|
11032077|NCT01214330|BG000|Baseline|Solopap|females, age >18, without severe hand arthritis
11032078|NCT01214330|FG000|Participant Flow|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
11032079|NCT01214330|OG000|Outcome|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
11032080|NCT01214330|EG000|Reported Event|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
11032081|NCT01214356|BG000|Baseline|Vitamin D Supplementation|vitamin D3 at 4000 IU/d
11032082|NCT01214356|BG001|Baseline|Usual Care|vitamin D3 at 400 IU/d
11032083|NCT01214356|BG002|Baseline|Total|Total of all reporting groups
11032084|NCT01214356|FG000|Participant Flow|Vitamin D|Vitamin D supplementation
11032085|NCT01214356|FG001|Participant Flow|Usual Care|vitamin D3 at 400 IU/d
11032086|NCT01214356|OG000|Outcome|Vitamin D Supplementation|vitamin D3 at 4000 IU/d
11032087|NCT01214356|OG001|Outcome|Usual Care|vitamin D3 at 400 IU/d
11032088|NCT01214356|EG000|Reported Event|Vitamin D Supplementation|vitamin D3 at 4000 IU/d
11032089|NCT01214356|EG001|Reported Event|Usual Care|vitamin D3 at 400 IU/d
11032090|NCT01214395|BG000|Baseline|Tea Tree Oil Application|tea tree oil medication group
11032091|NCT01214395|FG000|Participant Flow|Tea Tree Oil Application|tea tree oil medication group
11032092|NCT01214395|OG000|Outcome|Tea Tree Oil|tea tree oil application
11032093|NCT01214395|OG000|Outcome|Did Not Have Staph. Aureus Infection|No exit site infection or peritonitis with Staph. aureus
11032094|NCT01214395|EG000|Reported Event|Tea Tree Oil Application|tea tree oil medication group
11032095|NCT01214421|BG000|Baseline|Tolvaptan (From Study 156-04-251: Tolvaptan, Early Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with tolvaptan in previous Study 156-04-251, hence called as Early Treated.
11032096|NCT01214421|BG001|Baseline|Tolvaptan (From Study 156-04-251: Placebo, Delayed Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with placebo in the previous Study 156-04-251, hence called as Delayed Treated.
11349045|NCT04128293|OG000|Outcome|Treatment C- GSK3640254 200 mg Tablet (Fasted)|Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.
11032097|NCT01214421|BG002|Baseline|Tolvaptan (From Other Studies: Tolvaptan, Early Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with tolvaptan in other studies (156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290), hence called as Early Treated.
11032098|NCT01214421|BG003|Baseline|Tolvaptan (From Other Studies: Placebo, Delayed Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with placebo in other studies (156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290), hence called as Delayed Treated.
11032099|NCT01214421|BG004|Baseline|Total|Total of all reporting groups
11032100|NCT01214421|FG000|Participant Flow|Tolvaptan (From Study 156-04-251: Tolvaptan, Early Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 milligram (mg) in the morning [AM]/15 mg in the evening [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with tolvaptan in previous Study 156-04-251, hence called as Early Treated.
11032101|NCT01214421|FG001|Participant Flow|Tolvaptan (From Study 156-04-251: Placebo, Delayed Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with placebo in the previous Study 156-04-251, hence called as Delayed Treated.
11032102|NCT01214421|FG002|Participant Flow|Tolvaptan (From Other Studies: Tolvaptan, Early Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with tolvaptan in other studies (156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290), hence called as Early Treated.
11032103|NCT01214421|FG003|Participant Flow|Tolvaptan (From Other Studies: Placebo, Delayed Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with placebo in other studies (156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290), hence called as Delayed Treated.
11032104|NCT01214421|OG000|Outcome|Tolvaptan, Early Treated (From Study 156-04-251: Tolvaptan)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with tolvaptan in Study 156-04-251.
11032105|NCT01214421|OG001|Outcome|Tolvaptan, Delayed Treated (From Study 156-04-251: Placebo)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with placebo in Study 156-04-251.
11032106|NCT01214421|OG000|Outcome|Tolvaptan, Delayed Treated (In Study 156-08-271)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with placebo in Study 156-04-251.
11032107|NCT01214421|OG001|Outcome|Placebo (In Study 156-04-251)|Participants were treated with placebo in the previous Study 156-04-251.
11032108|NCT01214421|EG000|Reported Event|Tolvaptan (From Study 156-04-251: Tolvaptan, Early Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with tolvaptan in previous Study 156-04-251, hence called as Early Treated.
11032109|NCT01214421|EG001|Reported Event|Tolvaptan (From Study 156-04-251: Placebo, Delayed Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with placebo in the previous Study 156-04-251, hence called as Delayed Treated.
11032110|NCT01214421|EG002|Reported Event|Tolvaptan (From Other Studies: Tolvaptan, Early Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with tolvaptan in other studies (156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290), hence called as Early Treated.
11032111|NCT01214421|EG003|Reported Event|Tolvaptan (From Other Studies: Placebo, Delayed Treated)|Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 mg [AM]/15 mg [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily up to Month 24. Participants were previously treated with placebo in other studies (156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290), hence called as Delayed Treated.
11032112|NCT01214434|BG000|Baseline|Bland Emollient|Bland emollient : Eucerin cream twice daily
11032113|NCT01214434|BG001|Baseline|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
11032114|NCT01214434|BG002|Baseline|Total|Total of all reporting groups
11032115|NCT01214434|FG000|Participant Flow|Bland Emollient|Bland emollient : Eucerin cream twice daily
11032116|NCT01214434|FG001|Participant Flow|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
11032117|NCT01214434|OG000|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
11032118|NCT01214434|OG001|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
11032119|NCT01214434|EG000|Reported Event|Bland Emollient|Bland emollient : Eucerin cream twice daily
11032120|NCT01214434|EG001|Reported Event|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
11032121|NCT01214603|BG000|Baseline|Cohort 1, 40 mg LY2090314: D1, D8, D15|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032122|NCT01214603|BG001|Baseline|Cohort 2, 40 mg LY2090314: D1, D5, D9|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032123|NCT01214603|BG002|Baseline|Cohort 3, 40 mg LY2090314: D1, D5, D9, D12|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032124|NCT01214603|BG003|Baseline|Total|Total of all reporting groups
11032125|NCT01214603|FG000|Participant Flow|Cohort 1, 40 mg LY2090314: D1, D8, D15|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on Day (D)1, D8, and D15 for two 28-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032126|NCT01214603|FG001|Participant Flow|Cohort 2, 40 mg LY2090314: D1, D5, D9|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032127|NCT01214603|FG002|Participant Flow|Cohort 3, 40 mg LY2090314: D1, D5, D9, D12|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032128|NCT01214603|OG000|Outcome|Cohort 1, 40 mg LY2090314: D1, D8, D15|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032129|NCT01214603|OG001|Outcome|Cohort 2, 40 mg LY2090314: D1, D5, D9|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032130|NCT01214603|OG002|Outcome|Cohort 3, 40 mg LY2090314: D1, D5, D9, D12|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032131|NCT01214603|OG000|Outcome|Entire Study Population|"All participants who received at least 1 dose of LY2090314 regardless of the cohort to which they were enrolled.~Cohort 1: LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.~Cohort 2: LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.~Cohort 3: LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032132|NCT01214603|EG000|Reported Event|Cohort 1, 40 mg LY2090314: D1, D8, D15|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032133|NCT01214603|EG001|Reported Event|Cohort 2, 40 mg LY2090314: D1, D5, D9|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032134|NCT01214603|EG002|Reported Event|Cohort 3, 40 mg LY2090314: D1, D5, D9, D12|"LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.~If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met."
11032135|NCT01214616|BG000|Baseline|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
11032136|NCT01214616|BG001|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
11032137|NCT01214616|BG002|Baseline|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
11032138|NCT01214616|BG003|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
11032139|NCT01214616|BG004|Baseline|Total|Total of all reporting groups
11032140|NCT01214616|FG000|Participant Flow|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
11032141|NCT01214616|FG001|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
11032142|NCT01214616|FG002|Participant Flow|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
11032143|NCT01214616|FG003|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
11032144|NCT01214616|OG000|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
11032145|NCT01214616|OG001|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
11032146|NCT01214616|OG002|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
11032147|NCT01214616|OG003|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
11032148|NCT01214616|OG000|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as 20 mg afatinib with vinorelbine 25 mg/m2 or 40 mg afatinib with vinorelbine 20 mg/m2 or 40 mg afatinib with vinorelbine 25 mg/m2.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as without vinorelbine because no large effect of vinorelbine is expected from PK point of view."
11032149|NCT01214616|OG001|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as 20 mg afatinib with vinorelbine 25 mg/m2 or 40 mg afatinib with vinorelbine 20 mg/m2 or 40 mg afatinib with vinorelbine 25 mg/m2.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as without vinorelbine because no large effect of vinorelbine is expected from PK point of view."
11032150|NCT01214616|OG002|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as 20 mg afatinib with vinorelbine 25 mg/m2 or 40 mg afatinib with vinorelbine 20 mg/m2 or 40 mg afatinib with vinorelbine 25 mg/m2.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as without vinorelbine because no large effect of vinorelbine is expected from PK point of view."
11032151|NCT01214616|OG003|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as 20 mg afatinib with vinorelbine 25 mg/m2 or 40 mg afatinib with vinorelbine 20 mg/m2 or 40 mg afatinib with vinorelbine 25 mg/m2.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as without vinorelbine because no large effect of vinorelbine is expected from PK point of view."
11032152|NCT01214616|OG000|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as 20 mg afatinib with vinorelbine 25 mg/m2 or 40 mg afatinib with vinorelbine 20 mg/m2 or 40 mg afatinib with vinorelbine 25 mg/m2.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as without afatinib."
11032153|NCT01214616|OG001|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as 20 mg afatinib with vinorelbine 25 mg/m2 or 40 mg afatinib with vinorelbine 20 mg/m2 or 40 mg afatinib with vinorelbine 25 mg/m2.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as without afatinib."
11032154|NCT01214616|OG002|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as 20 mg afatinib with vinorelbine 25 mg/m2 or 40 mg afatinib with vinorelbine 20 mg/m2 or 40 mg afatinib with vinorelbine 25 mg/m2.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as without afatinib."
11032155|NCT01214616|OG003|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as 20 mg afatinib with vinorelbine 25 mg/m2 or 40 mg afatinib with vinorelbine 20 mg/m2 or 40 mg afatinib with vinorelbine 25 mg/m2.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as without afatinib."
11032156|NCT01214616|EG000|Reported Event|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
11032157|NCT01214616|EG001|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
11032158|NCT01214616|EG002|Reported Event|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
11032159|NCT01214616|EG003|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
11032160|NCT01214629|BG000|Baseline|0.125 mg/m²/Day LY|0.125 milligrams per meter square per day (mg/m²/day) LY2523355 (LY) was administered as an intravenous (IV) infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until progressive disease (PD), unacceptable toxicity or other withdrawal criterion is met
11032161|NCT01214629|BG001|Baseline|0.25 mg/m²/Day LY|0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032162|NCT01214629|BG002|Baseline|0.5 mg/m²/Day LY|0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032163|NCT01214629|BG003|Baseline|1.0 mg/m²/Day LY|1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032164|NCT01214629|BG004|Baseline|2.0 mg/m²/Day LY|2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met
11032165|NCT01214629|BG005|Baseline|4.0 mg/m²/Day LY|4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032166|NCT01214629|BG006|Baseline|5.0 mg/m²/Day LY|5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032167|NCT01214629|BG007|Baseline|6.0 mg/m²/Day LY|6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032168|NCT01214629|BG008|Baseline|4.0 mg/m²/Day LY + 6 mg PEG|"4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032169|NCT01214629|BG009|Baseline|6.0 mg/m²/Day LY + 6 mg PEG|"6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032170|NCT01214629|BG010|Baseline|7.0 mg/m²/Day LY + 6 mg PEG|"7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032171|NCT01214629|BG011|Baseline|Total|Total of all reporting groups
11032172|NCT01214629|FG000|Participant Flow|0.125 mg/m²/Day LY|0.125 milligrams per meter square per day (mg/m²/day) LY2523355 (LY) was administered as an intravenous (IV) infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until progressive disease (PD), unacceptable toxicity or other withdrawal criterion is met.
11032173|NCT01214629|FG001|Participant Flow|0.25 mg/m²/Day LY|0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032174|NCT01214629|FG002|Participant Flow|0.5 mg/m²/Day LY|0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032175|NCT01214629|FG003|Participant Flow|1.0 mg/m²/Day LY|1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032176|NCT01214629|FG004|Participant Flow|2.0 mg/m²/Day LY|2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032177|NCT01214629|FG005|Participant Flow|4.0 mg/m²/Day LY|4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032178|NCT01214629|FG006|Participant Flow|5.0 mg/m²/Day LY|5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032179|NCT01214629|FG007|Participant Flow|6.0 mg/m²/Day LY|6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032180|NCT01214629|FG008|Participant Flow|4.0 mg/m²/Day LY + 6 mg PEG|"4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032181|NCT01214629|FG009|Participant Flow|6.0 mg/m²/Day LY + 6 mg PEG|"6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032182|NCT01214629|FG010|Participant Flow|7.0 mg/m²/Day LY + 6 mg PEG|"7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032183|NCT01214629|OG000|Outcome|LY2523355|0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)
11032184|NCT01214629|OG001|Outcome|LY2523355 + Pegfilgrastim|4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).
11032185|NCT01214629|OG000|Outcome|0.125 mg/m²/Day LY|0.125 mg/m²/day LY2523355 (LY) was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032186|NCT01214629|OG001|Outcome|0.25 mg/m²/Day LY|0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032187|NCT01214629|OG002|Outcome|0.5 mg/m²/Day LY|0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032188|NCT01214629|OG003|Outcome|1.0 mg/m²/Day LY|1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032189|NCT01214629|OG004|Outcome|2.0 mg/m²/Day LY|2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032190|NCT01214629|OG005|Outcome|4.0 mg/m²/Day LY|4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032191|NCT01214629|OG006|Outcome|5.0 mg/m²/Day LY|5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032192|NCT01214629|OG007|Outcome|6.0 mg/m²/Day LY|6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032193|NCT01214629|OG008|Outcome|4.0 mg/m²/Day LY + 6 mg PEG|"4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met."
11032194|NCT01214629|OG009|Outcome|6.0 mg/m²/Day LY + 6 mg PEG|"6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032195|NCT01214629|OG010|Outcome|7.0 mg/m²/Day LY + 6 mg PEG|"7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032196|NCT01214629|OG000|Outcome|1.0 mg/m²/Day LY|1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).
11032197|NCT01214629|OG001|Outcome|2.0 mg/m²/Day LY|2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).
11032198|NCT01214629|OG002|Outcome|4.0 mg/m²/Day LY|4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).
11032199|NCT01214629|OG003|Outcome|5.0 mg/m²/Day LY|5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).
11032200|NCT01214629|OG004|Outcome|6.0 mg/m²/Day LY|6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).
11032201|NCT01214629|OG005|Outcome|7.0 mg/m²/Day LY|7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).
11032202|NCT01214629|OG000|Outcome|1.0 mg/m²/Day LY|1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle).
11032203|NCT01214629|OG001|Outcome|2.0 mg/m²/Day LY|2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle).
11032204|NCT01214629|OG002|Outcome|4.0 mg/m²/Day LY|4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle) or 4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day cycle).
11032205|NCT01214629|OG003|Outcome|5.0 mg/m²/Day LY|5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle).
11032206|NCT01214629|OG004|Outcome|6.0 mg/m²/Day LY|6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle) or 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day cycle).
11032207|NCT01214629|OG005|Outcome|7.0 mg/m²/Day LY|7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day cycle).
11032208|NCT01214629|EG000|Reported Event|0.125 mg/m²/Day LY|0.125 mg/m²/day LY2523355 (LY) was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032209|NCT01214629|EG001|Reported Event|0.25 mg/m²/Day LY|0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032210|NCT01214629|EG002|Reported Event|0.5 mg/m²/Day LY|0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032211|NCT01214629|EG003|Reported Event|1.0 mg/m²/Day LY|1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032212|NCT01214629|EG004|Reported Event|2.0 mg/m²/Day LY|2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032213|NCT01214629|EG005|Reported Event|4.0 mg/m²/Day LY|4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032214|NCT01214629|EG006|Reported Event|4.0 mg/m²/Day LY + 6 mg PEG|"4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032215|NCT01214629|EG007|Reported Event|5.0 mg/m²/Day LY|5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032216|NCT01214629|EG008|Reported Event|6.0 mg/m²/Day LY|6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
11032217|NCT01214629|EG009|Reported Event|6.0 mg/m²/Day LY + 6 mg PEG|"6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032218|NCT01214629|EG010|Reported Event|7.0 mg/m²/Day LY + 6 mg PEG|"7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.~6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.~Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met."
11032219|NCT01214642|BG000|Baseline|Part A - Days 1, 5, 9 - 2 mg/m^2/Day|2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032220|NCT01214642|BG001|Baseline|Part A - Days 1, 5, 9 - 4 mg/m^2/Day|4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032221|NCT01214642|BG002|Baseline|Part A - Days 1, 5, 9 - 8 mg/m^2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032222|NCT01214642|BG003|Baseline|Part A - Days 1, 5, 9 - 7 mg/m^2/Day|7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032223|NCT01214642|BG004|Baseline|Part A - Days 1, 5, 9 - 6 mg/m^2/Day|6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032224|NCT01214642|BG005|Baseline|Part A - Days 1, 5, 9 - 5 mg/m^2/Day|5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032225|NCT01214642|BG006|Baseline|Part A - Days 1, 8 - 8 mg/m^2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
11032226|NCT01214642|BG007|Baseline|Part A - Days 1, 5+PEG - 8 mg/m^2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
11032227|NCT01214642|BG008|Baseline|Part A and B - Days 1, 5+PEG - 12 mg/m^2/Day|12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 in Part A and Part B.
11032228|NCT01214642|BG009|Baseline|Part A - Days 1, 5+PEG - 16 mg/m^2/Day|16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032229|NCT01214642|BG010|Baseline|Part A - Days 1, 5+PEG - 14 mg/m^2/Day|14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032230|NCT01214642|BG011|Baseline|Part B - Days 1, 4+PEG - 12 mg/m^2/Day|12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
11032231|NCT01214642|BG012|Baseline|Total|Total of all reporting groups
11032232|NCT01214642|FG000|Participant Flow|Part A - Days 1, 5, 9 - 2 mg/m^2/Day|2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032233|NCT01214642|FG001|Participant Flow|Part A - Days 1, 5, 9 - 4 mg/m^2/Day|4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032234|NCT01214642|FG002|Participant Flow|Part A - Days 1, 5, 9 - 8 mg/m^2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032235|NCT01214642|FG003|Participant Flow|Part A - Days 1, 5, 9 - 7 mg/m^2/Day|7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032236|NCT01214642|FG004|Participant Flow|Part A - Days 1, 5, 9 - 6 mg/m^2/Day|6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032237|NCT01214642|FG005|Participant Flow|Part A - Days 1, 5, 9 - 5 mg/m^2/Day|5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032238|NCT01214642|FG006|Participant Flow|Part A - Days 1, 8 - 8 mg/m^2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
11032239|NCT01214642|FG007|Participant Flow|Part A - Days 1, 5+PEG - 8 mg/m^2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
11032240|NCT01214642|FG008|Participant Flow|Part A and B- Days 1, 5+PEG - 12 mg/m^2/Day|12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032241|NCT01214642|FG009|Participant Flow|Part A - Days 1, 5+PEG - 16 mg/m^2/Day|16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032242|NCT01214642|FG010|Participant Flow|Part A - Days 1, 5+PEG - 14 mg/m^2/Day|14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032243|NCT01214642|FG011|Participant Flow|Part B - Days 1, 4+PEG - 12 mg/m^2/Day|12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
11032244|NCT01214642|OG000|Outcome|LY2523355 / LY2523355 +PEG|Escalating doses starting at 2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m^2/day.
11032245|NCT01214642|OG000|Outcome|Part A - Days 1, 5, 9 - 2 mg/m^2/Day|2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032246|NCT01214642|OG001|Outcome|Part A - Days 1, 5, 9 - 4 mg/m^2/Day|4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032247|NCT01214642|OG002|Outcome|Part A - Days 1, 5, 9 - 8 mg/m^2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032248|NCT01214642|OG003|Outcome|Part A - Days 1, 5, 9 - 7 mg/m^2/Day|7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032249|NCT01214642|OG004|Outcome|Part A - Days 1, 5, 9 - 6 mg/m^2/Day|6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032250|NCT01214642|OG005|Outcome|Part A - Days 1, 5, 9 - 5 mg/m^2/Day|5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032251|NCT01214642|OG006|Outcome|Part A - Days 1, 8 - 8 mg/m^2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
11032252|NCT01214642|OG007|Outcome|Part A - Days 1, 5+PEG - 8 mg/m2/Day|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
11032253|NCT01214642|OG008|Outcome|Part A - Days 1, 5+PEG - 12 mg/m^2/Day|12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032254|NCT01214642|OG009|Outcome|Part A - Days 1, 5+PEG - 16 mg/m^2/Day|16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032255|NCT01214642|OG010|Outcome|Part A - Days 1, 5+PEG - 14 mg/m^2/Day|14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032256|NCT01214642|OG011|Outcome|Part B - Days 1, 5+PEG - 12 mg/m^2/Day|12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032257|NCT01214642|OG012|Outcome|Part B - Days 1, 4+PEG - 12 mg/m^2/d|12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
11032258|NCT01214642|OG000|Outcome|2 mg/m^2/Day LY2523355|2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032259|NCT01214642|OG001|Outcome|4 mg/m^2/Day LY2523355|4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032260|NCT01214642|OG002|Outcome|5 mg/m^2/Day LY2523355|5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032261|NCT01214642|OG003|Outcome|6 mg/m^2/Day LY2523355|6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032262|NCT01214642|OG004|Outcome|7 mg/m^2/Day LY2523355|7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032263|NCT01214642|OG005|Outcome|8 mg/m^2/Day LY2523355|8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion across all schedules and in the presence or absence of PEG administered subcutaneously.
11032264|NCT01214642|OG006|Outcome|12 mg/m^2/Day LY2523355|12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 and on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
11032265|NCT01214642|OG007|Outcome|14 mg/m^2/Day LY2523355|14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032266|NCT01214642|OG008|Outcome|16 mg/m^2/Day LY2523355|16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032267|NCT01214642|OG002|Outcome|5 mg/m^2/Day LY25233552|5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032268|NCT01214642|OG000|Outcome|LY2523355 Days 1, 5 and 9|Escalating dose started at 2 milligrams per meter squared (mg/m^2) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5 and 9, for two planned cycles of 21 days. Dose could be escalated by a maximum increment of the lesser of doubling the current dose or 4 milligrams per meter squared per day (mg/m^2/day), with a maximum allowed dose of 30 mg/m^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21 days.
11349046|NCT04128293|OG001|Outcome|Treatment D- GSK3640254 200 mg Tablet (High Fat)|Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
11032269|NCT01214642|OG001|Outcome|LY2523355 Days 1 and 8|Escalating dose started at 8 mg/m^2 of LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 for two planned 21-day cycles. Dose could be escalated by a maximum of 4 mg/m^2/day, with a maximum allowed dose of 30 mg/m^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.
11032270|NCT01214642|OG002|Outcome|LY2523355 Days 1 and 5 + PEG|Escalating dose started at 8 mg/m^2 LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5, for two planned cycles of 21-days and 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Dose could be escalated by a maximum of 4 mg/m^2/day, with a maximum allowed dose of 30 mg/m^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.
11032271|NCT01214642|OG003|Outcome|LY2523355 Days 1 and 4 + PEG|12 mg/m^2 LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4, for two planned 21 days cycles, 6 mg PEG administered subcutaneously on Day 5 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.
11032272|NCT01214642|EG000|Reported Event|Part A - Days 1, 5, 9 - 2 mg/m^2/Day|Part A (Dose Escalation Phase): 2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032273|NCT01214642|EG001|Reported Event|Part A - Days 1, 5, 9 - 4 mg/m^2/Day|Part A (Dose Escalation Phase): 4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032274|NCT01214642|EG002|Reported Event|Part A - Days 1, 5, 9 - 8 mg/m^2/Day|Part A (Dose Escalation Phase): 8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032275|NCT01214642|EG003|Reported Event|Part A - Days 1, 5, 9 - 7 mg/m^2/Day|Part A (Dose Escalation Phase): 7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032276|NCT01214642|EG004|Reported Event|Part A - Days 1, 5, 9 - 6 mg/m^2/Day|Part A (Dose Escalation Phase): 6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032277|NCT01214642|EG005|Reported Event|Part A - Days 1, 5, 9 - 5 mg/m^2/Day|Part A (Dose Escalation Phase): 5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
11032278|NCT01214642|EG006|Reported Event|Part A - Days 1, 8 - 8 mg/m^2/Day|Part A (Dose Escalation Phase): 8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
11032279|NCT01214642|EG007|Reported Event|Part A - Days 1, 5+PEG - 8 mg/m^2/Day|Part A (Dose Escalation Phase): 8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
11032280|NCT01214642|EG008|Reported Event|Part A - Days 1, 5+PEG - 12 mg/m^2/Day|Part A (Dose Escalation Phase): 12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032281|NCT01214642|EG009|Reported Event|Part A - Days 1, 5+PEG - 16 mg/m^2/Day|Part A (Dose Escalation Phase): 16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032282|NCT01214642|EG010|Reported Event|Part A - Days 1, 5+PEG - 14 mg/m^2/Day|Part A (Dose Escalation Phase): 14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032283|NCT01214642|EG011|Reported Event|Part B - Days 1, 5+PEG - 12 mg/m^2/Day|Part B (Dose Maintenance Phase): 12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
11032284|NCT01214642|EG012|Reported Event|Part B - Days 1, 4+PEG - 12 mg/m^2/d|Part B (Dose Maintenance Phase): 12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously Day 5.
11032285|NCT01214655|BG000|Baseline|Schedule A LY2523355|Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by intravenous (IV) infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
11032286|NCT01214655|BG001|Baseline|Schedule B LY2523355|Starting dose was 8 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
11032287|NCT01214655|BG002|Baseline|Schedule C LY2523355|"Starting dose was 5 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.~No participants in Part C escalated from their initial dose."
11032288|NCT01214655|BG003|Baseline|Total|Total of all reporting groups
11032289|NCT01214655|FG000|Participant Flow|Schedule A LY2523355|Participants received a dose escalation to maximum tolerated dose (MTD) from 2 mg/m²/day to 4,5 and 6 mg/m²/day during a 1 hour (hr) infusion on Days 1,2, 3 (Schedule A) of a 21 day cycle. Participants did not have to escalate doses and participants could join at a higher dose level.
11032290|NCT01214655|FG001|Participant Flow|Schedule B LY2523355|Participants received a dose escalation to maximum tolerated dose (MTD) ranging from 8 mg/m²/day (starting dose) to 10,12 and 14 mg/m²/day during a 1 hour (hr) infusion on Days 1,5, 9 (Schedule B)of a 21 day cycle Participants did not have to escalate doses and participants could join at a higher dose level.
11032291|NCT01214655|FG002|Participant Flow|Schedule C LY2523355|Starting dose was 5 mg/m²/day administered by IV infusion over 1 hour on Days 1, 2, and 3 (Schedule C) of every 21-day Cycle.
11032292|NCT01214655|OG000|Outcome|LY2523355|Escalating doses starting at 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
11032293|NCT01214655|OG000|Outcome|Schedule A LY2523355|Escalating doses starting at 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study.
11032294|NCT01214655|OG001|Outcome|Schedule B LY2523355|Starting dose was 8 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
11032295|NCT01214655|OG002|Outcome|Schedule C LY2523355|Starting dose was 5 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
11032296|NCT01214655|OG000|Outcome|Schedule A 2 mg LY2523355|2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
11032297|NCT01214655|OG001|Outcome|Schedule A 4 mg LY2524455|4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
11032298|NCT01214655|OG002|Outcome|Schedule A,C 5 mg LY2523355|Schedule A 5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A and Part C combined.
11032299|NCT01214655|OG003|Outcome|Schedule A 6 mg LY2523355|6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
11032300|NCT01214655|OG004|Outcome|Schedule B 8 mg LY2523355|8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
11032301|NCT01214655|OG005|Outcome|Schedule B 10 mg LY2523355|10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
11032302|NCT01214655|OG006|Outcome|Schedule B 12 mg LY2523355|12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
11032303|NCT01214655|OG007|Outcome|Schedule B 14 mg 2523355|14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
11032304|NCT01214655|OG008|Outcome|Schedule B 16 mg LY2523355|16 mg/m²/day was inadvertently given to a participant.
11032305|NCT01214655|OG000|Outcome|Schedule A Day 3 2 mg LY2523355|2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
11032306|NCT01214655|OG001|Outcome|Schedule A Day 3 4 mg LY2523355|4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
11032307|NCT01214655|OG002|Outcome|Schedule A/C Day 3 5 mg LY2523355|5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
11032308|NCT01214655|OG003|Outcome|Schedule A Day 3 6 mg LY2523355|6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
11032309|NCT01214655|OG004|Outcome|Schedule B Day 9 8 mg LY2523355|8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle
11032310|NCT01214655|OG005|Outcome|Schedule B Day 9 10 mg LY2523355|10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle
11032311|NCT01214655|OG006|Outcome|Schedule B Day 9 12 mg LY2523355|12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A, Part B and Part C.
11032312|NCT01214655|OG007|Outcome|Schedule B Day 9 14 mg LY2523355|14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle
11032313|NCT01214655|OG000|Outcome|Schedule A Day 1 2 mg LY2523355|2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
11032314|NCT01214655|OG001|Outcome|Schedule A Day 1 4 mg LY2524455|4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
11032315|NCT01214655|OG002|Outcome|Schedule A,C Day 1 5 mg LY2523355|5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A and Part C combined.
11032316|NCT01214655|OG003|Outcome|Schedule A Day 1 6 mg LY2523355|6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
11032317|NCT01214655|OG004|Outcome|Schedule B Day 1 8 mg LY2523355|8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
11032318|NCT01214655|OG005|Outcome|Schedule B Day 1 10 mg LY2523355|10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
11032319|NCT01214655|OG006|Outcome|Schedule B Day 1 12 mg LY2523355|12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
11032320|NCT01214655|OG007|Outcome|Schedule B Day 1 14 mg 2523355|14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
11032321|NCT01214655|OG008|Outcome|Schedule B Day 1 16 mg LY2523355|16 mg/m²/day was inadvertently given to a participant.
11032322|NCT01214655|OG000|Outcome|Schedule A LY2523355 Days 1, 2, and 3|"Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.~Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day)."
11032323|NCT01214655|OG001|Outcome|Schedule B LY2523355 Days 1, 5, and 9|"Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.~Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day)."
11032324|NCT01214655|OG002|Outcome|Schedule C LY2523355 Days 1, 2, and 3|"Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.~No participants in Part C escalated from their initial dose."
11349047|NCT04128293|OG000|Outcome|Treatment B- GSK3640254 200 mg Tablet (Fed)|Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
10887049|NCT00498602|BG003|Baseline|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032325|NCT01214655|OG000|Outcome|Schedule A LY2523355 Days 1, 2, and 3|"Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day Cycle.~Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day)."
11032326|NCT01214655|OG000|Outcome|Schedule LY2523355 Days 1, 2, and 3|"Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day Cycle.~Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day)."
11032327|NCT01214655|EG000|Reported Event|Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3|Dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.
11032328|NCT01214655|EG001|Reported Event|Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3|Dose was 4 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
11032329|NCT01214655|EG002|Reported Event|Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3|Dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
11032330|NCT01214655|EG003|Reported Event|Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3|Dose was 6 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
11032331|NCT01214655|EG004|Reported Event|Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9|Dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
11032332|NCT01214655|EG005|Reported Event|Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9|Dose was 10 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
10887050|NCT00498602|BG004|Baseline|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032333|NCT01214655|EG006|Reported Event|Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9|Dose was 12 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
11032334|NCT01214655|EG007|Reported Event|Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9|Dose was 14 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
11032335|NCT01214655|EG008|Reported Event|Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3|Dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
11032336|NCT01214668|BG000|Baseline|LY 300 μg/mL + Dox|LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.
11032337|NCT01214668|BG001|Baseline|LY 320 μg/mL + Dox|LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032338|NCT01214668|BG002|Baseline|LY 340 μg/mL + Dox|LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032339|NCT01214668|BG003|Baseline|LY 360 μg/mL + Dox|LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032340|NCT01214668|BG004|Baseline|LY 380 μg/mL + Dox|LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032341|NCT01214668|BG005|Baseline|LY Albumin and Day 15 PK Tailored + Dox|LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*μg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
11032342|NCT01214668|BG006|Baseline|Total|Total of all reporting groups
11032343|NCT01214668|FG000|Participant Flow|LY 300 μg/mL + Dox|LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.
11032344|NCT01214668|FG001|Participant Flow|LY 320 μg/mL + Dox|LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032345|NCT01214668|FG002|Participant Flow|LY 340 μg/mL + Dox|LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032346|NCT01214668|FG003|Participant Flow|LY 360 μg/mL + Dox|LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032347|NCT01214668|FG004|Participant Flow|LY 380 μg/mL + Dox|LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11349048|NCT04128293|OG001|Outcome|Treatment C- GSK3640254 200 mg Tablet (Fasted)|Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.
10887051|NCT00498602|BG005|Baseline|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10887052|NCT00498602|BG006|Baseline|Phosphate Buffered Saline|Participants received PBS. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032348|NCT01214668|FG005|Participant Flow|LY Albumin and Day 15 PK Tailored + Dox|LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
11032349|NCT01214668|OG000|Outcome|LY 300 μg/mL + Dox|LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.
11032350|NCT01214668|OG001|Outcome|LY 320 μg/mL + Dox|LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032351|NCT01214668|OG002|Outcome|LY 340 μg/mL + Dox|LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032352|NCT01214668|OG003|Outcome|LY 360 μg/mL + Dox|LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032353|NCT01214668|OG004|Outcome|LY 380 μg/mL + Dox|LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032354|NCT01214668|OG005|Outcome|LY Albumin and Day 15 PK Tailored + Dox|LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
11032355|NCT01214668|OG000|Outcome|LY573636|LY573636 dose was based on an albumin-corrected exposure (AUCalb) to target a specific exposure range. Intravenous dosing is done on Day 1 of a 28-day cycle. Data are pooled together from all treatment groups.
11032356|NCT01214668|EG000|Reported Event|LY 300 μg/mL + Dox|LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.
11032357|NCT01214668|EG001|Reported Event|LY 320 μg/mL + Dox|LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032358|NCT01214668|EG002|Reported Event|LY 340 μg/mL + Dox|LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032359|NCT01214668|EG003|Reported Event|LY 360 μg/mL + Dox|LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032360|NCT01214668|EG004|Reported Event|LY 380 μg/mL + Dox|LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
11032361|NCT01214668|EG005|Reported Event|LY Albumin and Day 15 PK Tailored + Dox|LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
11032362|NCT01214720|BG000|Baseline|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
11032363|NCT01214720|BG001|Baseline|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
11032364|NCT01214720|BG002|Baseline|Total|Total of all reporting groups
11225850|NCT02370537|OG002|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
10887053|NCT00498602|BG007|Baseline|Total|Total of all reporting groups
11032365|NCT01214720|FG000|Participant Flow|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg per square meter (mg/m^2) IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, orally (PO), once daily (QD) for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
11032366|NCT01214720|FG001|Participant Flow|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
11032367|NCT01214720|OG000|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
11032368|NCT01214720|OG001|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
11032369|NCT01214720|EG000|Reported Event|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
11032370|NCT01214720|EG001|Reported Event|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
11032371|NCT01214759|BG000|Baseline|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
11032372|NCT01214759|FG000|Participant Flow|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
11032373|NCT01214759|OG000|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
11032374|NCT01214759|EG000|Reported Event|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
11032375|NCT01214811|BG000|Baseline|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
11032376|NCT01214811|FG000|Participant Flow|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
11032377|NCT01214811|OG000|Outcome|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
11032378|NCT01214811|EG000|Reported Event|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
11032379|NCT01214824|BG000|Baseline|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
11032380|NCT01214824|FG000|Participant Flow|Intervention Group|Participants using the FreeStyle Navigator System Intermittently. At the start and end of the study subjects wore the FreeStyle Navigator masked (without seeing continuous glucose results) for 5 days (1 sensor wear). During the study subjects used the FreeStyle Navigator fully functional (unmasked) for 2 periods. The first unmasked phase was for 2 weeks (3 sensor wears) following the baseline masked wear. The second unmasked phase was a 5 day wear at 3 months. After each unmasked phase the HCP reviewed results with the subject and changes to insulin regimen were recommended as required. For the remainder of the study a standard blood glucose meter was used for diabetes management.
11032381|NCT01214824|OG000|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
11032382|NCT01214824|OG000|Outcome|Intervention Group|Participants using the FreeStyle Navigator System intermittently
11032383|NCT01214824|EG000|Reported Event|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
11032384|NCT01214837|BG000|Baseline|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
11032385|NCT01214837|BG001|Baseline|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
11032386|NCT01214837|BG002|Baseline|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
11032387|NCT01214837|BG003|Baseline|Total|Total of all reporting groups
11032388|NCT01214837|FG000|Participant Flow|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
11032389|NCT01214837|FG001|Participant Flow|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
11032390|NCT01214837|FG002|Participant Flow|Routine Vaccines|Subjects received routine vaccines only, including pneumococcal 13-valent conjugate vaccine (PCV-13), at 2, 4, 6 and 12 months of age.
11032391|NCT01214837|OG000|Outcome|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
11032392|NCT01214837|OG000|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
11032393|NCT01214837|OG001|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
11032394|NCT01214837|OG002|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
11032395|NCT01214837|EG000|Reported Event|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
11032396|NCT01214837|EG001|Reported Event|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
11032397|NCT01214837|EG002|Reported Event|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
11032398|NCT01214850|BG000|Baseline|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
11032399|NCT01214850|BG001|Baseline|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
11032400|NCT01214850|BG002|Baseline|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
11032401|NCT01214850|BG003|Baseline|Total|Total of all reporting groups
11032402|NCT01214850|FG000|Participant Flow|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
11032403|NCT01214850|FG001|Participant Flow|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
11032404|NCT01214850|FG002|Participant Flow|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
11032405|NCT01214850|OG000|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
11032406|NCT01214850|OG001|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
11032407|NCT01214850|OG000|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
11032408|NCT01214850|OG001|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
11032409|NCT01214850|OG001|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
11032410|NCT01214850|OG002|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
11032411|NCT01214850|EG000|Reported Event|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
11032412|NCT01214850|EG001|Reported Event|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
11032413|NCT01214850|EG002|Reported Event|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
11032414|NCT01214915|BG000|Baseline|Anagrelide Hydrochloride|
11032415|NCT01214915|FG000|Participant Flow|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
11032416|NCT01214915|OG000|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
11032417|NCT01214915|EG000|Reported Event|Anagrelide Hydrochloride|
11032418|NCT01214980|BG000|Baseline|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
11032419|NCT01214980|BG001|Baseline|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
11032420|NCT01214980|BG002|Baseline|Total|Total of all reporting groups
11032421|NCT01214980|FG000|Participant Flow|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
11032422|NCT01214980|FG001|Participant Flow|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
11032423|NCT01214980|OG000|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
11032424|NCT01214980|OG001|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
11032425|NCT01214980|EG000|Reported Event|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
11032426|NCT01214980|EG001|Reported Event|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
11066433|NCT01392378|FG002|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
11066434|NCT01392378|FG003|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
11066435|NCT01392378|FG004|Participant Flow|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
11066436|NCT01392378|OG000|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
11066437|NCT01392378|OG001|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
11066438|NCT01392378|OG002|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
11066439|NCT01392378|OG003|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
11066440|NCT01392378|OG004|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
11349049|NCT04128293|OG002|Outcome|Treatment D- GSK3640254 200 mg Tablet (High Fat)|Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
11349050|NCT04128293|OG002|Outcome|Treatment C- GSK3640254 200 mg Tablet (Fasted)|Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.
10887054|NCT00498602|FG000|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032427|NCT01215032|BG000|Baseline|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
11032428|NCT01215032|FG000|Participant Flow|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
11032429|NCT01215032|OG000|Outcome|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
11032430|NCT01215032|OG000|Outcome|Normal Baseline Hemoglobin A1c|Hemoglobin A1c less than 6.0 before metformin dosing began.
11032431|NCT01215032|OG001|Outcome|Abnormal Baseline Hemoglobin A1c|Hemoglobin A1c greater than or equal to 6.0 before metformin dosing began.
11032432|NCT01215032|EG000|Reported Event|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
11032433|NCT01215097|BG000|Baseline|Placebo|Placebo
11032434|NCT01215097|BG001|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
11032435|NCT01215097|BG002|Baseline|Total|Total of all reporting groups
11032436|NCT01215097|FG000|Participant Flow|Placebo|Placebo
11032437|NCT01215097|FG001|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
11032438|NCT01215097|OG000|Outcome|Placebo|Placebo
11032439|NCT01215097|OG001|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
11032440|NCT01215097|EG000|Reported Event|Placebo|Placebo
11032441|NCT01215097|EG001|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
11032442|NCT01215110|BG000|Baseline|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
11032443|NCT01215110|BG001|Baseline|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
10887055|NCT00498602|FG001|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032444|NCT01215110|BG002|Baseline|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
11032445|NCT01215110|BG003|Baseline|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
11032446|NCT01215110|BG004|Baseline|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
10887056|NCT00498602|FG002|Participant Flow|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10887057|NCT00498602|FG003|Participant Flow|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032447|NCT01215110|BG005|Baseline|Total|Total of all reporting groups
11032448|NCT01215110|FG000|Participant Flow|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
11032449|NCT01215110|FG001|Participant Flow|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
11032450|NCT01215110|FG002|Participant Flow|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
11032451|NCT01215110|FG003|Participant Flow|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
11032452|NCT01215110|FG004|Participant Flow|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
11032453|NCT01215110|OG000|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
11032454|NCT01215110|OG001|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
11032455|NCT01215110|OG002|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
11032456|NCT01215110|OG003|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
11032457|NCT01215110|OG004|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
11032458|NCT01215110|OG000|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
11032459|NCT01215110|OG001|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
11032460|NCT01215110|OG002|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
11032461|NCT01215110|OG003|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
11032462|NCT01215110|EG000|Reported Event|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
11032463|NCT01215110|EG001|Reported Event|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
11032464|NCT01215110|EG002|Reported Event|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
11032465|NCT01215110|EG003|Reported Event|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
11032466|NCT01215110|EG004|Reported Event|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
11032467|NCT01215123|BG000|Baseline|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
11032468|NCT01215123|FG000|Participant Flow|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
11032469|NCT01215123|OG000|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
11032470|NCT01215123|EG000|Reported Event|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
11032471|NCT01215175|BG000|Baseline|V114 Adjuvanted - Adult Cohort|Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
11032472|NCT01215175|BG001|Baseline|Prevnar™ - Adult Cohort|Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
11032473|NCT01215175|BG002|Baseline|V114 Adjuvanted - Toddler Cohort|Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.
11032474|NCT01215175|BG003|Baseline|V114 Nonadjuvanted-Toddler Cohort|Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.
11032475|NCT01215175|BG004|Baseline|Prevnar™ - Toddler Cohort|Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
11032476|NCT01215175|BG005|Baseline|Total|Total of all reporting groups
11032477|NCT01215175|FG000|Participant Flow|V114 Adjuvanted - Adult Cohort|Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
11032478|NCT01215175|FG001|Participant Flow|Prevnar™ - Adult Cohort|Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
11032479|NCT01215175|FG002|Participant Flow|V114 Adjuvanted - Toddler Cohort|Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.
11032480|NCT01215175|FG003|Participant Flow|V114 Nonadjuvanted-Toddler Cohort|Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.
11032481|NCT01215175|FG004|Participant Flow|Prevnar™ - Toddler Cohort|Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
11032482|NCT01215175|OG000|Outcome|V114 Adjuvanted - Adult Cohort|Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
11032483|NCT01215175|OG001|Outcome|Prevnar™ - Adult Cohort|Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
11032484|NCT01215175|OG000|Outcome|V114 Adjuvanted - Toddler Cohort|Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.
11032485|NCT01215175|OG001|Outcome|V114 Nonadjuvanted-Toddler Cohort|Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.
11032486|NCT01215175|OG002|Outcome|Prevnar™ - Toddler Cohort|Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
11032487|NCT01215175|EG000|Reported Event|V114 Adjuvanted -Adult Cohort|Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
11032488|NCT01215175|EG001|Reported Event|PREVNAR™-Adult Cohort|Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
11032489|NCT01215175|EG002|Reported Event|V114 Adjuvanted- Toddler Cohort|Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum nonadjuvanted V114 on Day 1.
11032490|NCT01215175|EG003|Reported Event|V114 Nonadjuvanted-toddler Cohort|Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum nonadjuvanted V114 on Day 1.
10887058|NCT00498602|FG004|Participant Flow|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032491|NCT01215175|EG004|Reported Event|PREVNAR™- Toddler Cohort|Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
11032492|NCT01215188|BG000|Baseline|V114 Adjuvanted|Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
11032493|NCT01215188|BG001|Baseline|V114 Nonadjuvanted|Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
11032494|NCT01215188|BG002|Baseline|PREVNAR 13®|Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
11032495|NCT01215188|BG003|Baseline|Total|Total of all reporting groups
11032496|NCT01215188|FG000|Participant Flow|V114 Adjuvanted|Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
11032497|NCT01215188|FG001|Participant Flow|V114 Nonadjuvanted|Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
11032498|NCT01215188|FG002|Participant Flow|PREVNAR 13®|Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
11032499|NCT01215188|OG000|Outcome|V114 Adjuvanted|Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
11032500|NCT01215188|OG001|Outcome|V114 Nonadjuvanted|Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
11032501|NCT01215188|OG002|Outcome|PREVNAR 13®|Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
11032502|NCT01215188|EG000|Reported Event|V114|Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
11032503|NCT01215188|EG001|Reported Event|V114 Non-Adjuvanted|Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
11032504|NCT01215188|EG002|Reported Event|Prevnar|Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
11032505|NCT01215227|BG000|Baseline|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032506|NCT01215227|BG001|Baseline|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032507|NCT01215227|BG002|Baseline|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032508|NCT01215227|BG003|Baseline|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032509|NCT01215227|BG004|Baseline|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
11032510|NCT01215227|BG005|Baseline|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
11032511|NCT01215227|BG006|Baseline|Total|Total of all reporting groups
11032512|NCT01215227|FG000|Participant Flow|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032513|NCT01215227|FG001|Participant Flow|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032514|NCT01215227|FG002|Participant Flow|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032515|NCT01215227|FG003|Participant Flow|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032516|NCT01215227|FG004|Participant Flow|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
11032517|NCT01215227|FG005|Participant Flow|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
11032518|NCT01215227|OG000|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
10887059|NCT00498602|FG005|Participant Flow|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
10887060|NCT00498602|FG006|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032519|NCT01215227|OG001|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032520|NCT01215227|OG002|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032521|NCT01215227|OG003|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032522|NCT01215227|OG004|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
11349051|NCT04128293|OG003|Outcome|Treatment D- GSK3640254 200 mg Tablet (High Fat)|Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
11032523|NCT01215227|OG005|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
11032524|NCT01215227|EG000|Reported Event|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032525|NCT01215227|EG001|Reported Event|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032526|NCT01215227|EG002|Reported Event|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032527|NCT01215227|EG003|Reported Event|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
11032528|NCT01215227|EG004|Reported Event|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
11032529|NCT01215227|EG005|Reported Event|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
11032530|NCT01215240|BG000|Baseline|Prophylactic Peritoneal Dialysis|"Prophylactic peritoneal dialysis~Peritoneal dialysis: Prophylactic peritoneal dialysis"
11032531|NCT01215240|BG001|Baseline|Standard Care Without PDC|Standard care with diuretics
11032532|NCT01215240|BG002|Baseline|Total|Total of all reporting groups
11032533|NCT01215240|FG000|Participant Flow|Prophylactic Peritoneal Dialysis|"A peritoneal dialysis catheter (PDC) was inserted at the time of the Norwood operation. The PDC was left open to drainage until the patient was stable enough to start peritoneal dialysis cycles.~Criteria to start PD cycles included: no fluid bolus given within the past four hours; no escalation of inotropes or vasopressors within the last two hours; vasoactive inotropes score (VIS) ≤ 15; and oxygen saturations ≥ 65% on FiO2 ≤ 0.4.~PD cycles consisted initially of 10 ml/kg dwell volumes with initial 1.5% dextrose concentration and 60 minute manual cycles (in/dwell 40 minutes, drain 20 minutes)."
11032534|NCT01215240|FG001|Participant Flow|Standard Care Without PDC|This group did not receive a peritoneal dialysis catheter at the time of their Norwood. This group received standard care according to their attending physician. At our institution, diuresis is typically initiated with furosemide, either by continuous infusion or bolus dosing at the discretion of the treating team. Study design allowed for placement of a peritoneal dialysis catheter if clinically indicated due to recalcitrant hyperkalemia (serum potassium > 5.9 mEq/L), volume overload unresponsive to diuretics, abdominal compartment syndrome, oliguria (urine output < 1 ml/kg/hr) for more than four hours despite medical intervention or increased serum creatinine in association with persistent metabolic acidosis or low cardiac output syndrome (LCOS).
11032535|NCT01215240|OG000|Outcome|Prophylactic Peritoneal Dialysis|"Prophylactic peritoneal dialysis~Peritoneal dialysis: Prophylactic peritoneal dialysis"
11032536|NCT01215240|OG001|Outcome|Standard Care Without PDC|
11032537|NCT01215240|EG000|Reported Event|Prophylactic Peritoneal Dialysis|"Prophylactic peritoneal dialysis~Peritoneal dialysis: Prophylactic peritoneal dialysis"
11032538|NCT01215240|EG001|Reported Event|Standard Care Without PDC|
11032539|NCT01215253|BG000|Baseline|Ranolazine|"At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.~Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week."
11032540|NCT01215253|BG001|Baseline|Placebo|Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
11032541|NCT01215253|BG002|Baseline|Total|Total of all reporting groups
11032542|NCT01215253|FG000|Participant Flow|Ranolazine|"At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.~Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week."
11032543|NCT01215253|FG001|Participant Flow|Placebo|Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
11032544|NCT01215253|OG000|Outcome|Ranolazine|"At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.~Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week."
11032545|NCT01215253|OG001|Outcome|Placebo|Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
11032546|NCT01215253|OG001|Outcome|Placebo|"At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.~Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week."
11032547|NCT01215253|EG000|Reported Event|Ranolazine|"At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.~Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week."
11032548|NCT01215253|EG001|Reported Event|Placebo|Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
11032549|NCT01215279|BG000|Baseline|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
11032550|NCT01215279|BG001|Baseline|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
11032551|NCT01215279|BG002|Baseline|Total|Total of all reporting groups
10887061|NCT00498602|OG000|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032552|NCT01215279|FG000|Participant Flow|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
11032553|NCT01215279|FG001|Participant Flow|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
11032554|NCT01215279|OG000|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
11032555|NCT01215279|OG001|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
11032556|NCT01215279|EG000|Reported Event|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
11032557|NCT01215279|EG001|Reported Event|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
11032558|NCT01215292|BG000|Baseline|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
11032559|NCT01215292|BG001|Baseline|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
11032560|NCT01215292|BG002|Baseline|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
11032561|NCT01215292|BG003|Baseline|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
10887062|NCT00498602|OG001|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032562|NCT01215292|BG004|Baseline|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
11032563|NCT01215292|BG005|Baseline|Total|Total of all reporting groups
11032564|NCT01215292|FG000|Participant Flow|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
11032565|NCT01215292|FG001|Participant Flow|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
11032566|NCT01215292|FG002|Participant Flow|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
11032567|NCT01215292|FG003|Participant Flow|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
11032568|NCT01215292|FG004|Participant Flow|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
11032569|NCT01215292|OG000|Outcome|Acyline + Testosterone Gel + Placebo|300mcg Acyline, 1% testosterone gel 5g daily + placebo
11032570|NCT01215292|OG001|Outcome|Acyline + Tgel + Ketoconazole 400mg|300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole
11032571|NCT01215292|OG002|Outcome|Acyline + Tgel + Ketoconazole 800mg|300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
11032572|NCT01215292|OG003|Outcome|Acyline & TGel & Dutasteride 2.5mg|
11032573|NCT01215292|OG004|Outcome|Acyline & TGel & Anastrazole 1mg|
11032574|NCT01215292|OG000|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + placebo
11032575|NCT01215292|OG001|Outcome|Acyline & TGel & Ketoconazole 400 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + ketoconazole 400mg x 7 days
11225851|NCT02370537|OG003|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
11032576|NCT01215292|OG002|Outcome|Acyline & TGel & Ketoconazole 800 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + 800mg ketoconazole x 7 days
11032577|NCT01215292|OG003|Outcome|Acyline & TGel & Dutasteride|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + dutasteride 2.5mg x 7 days
11032578|NCT01215292|OG004|Outcome|Acyline & TGel & Anastrazole|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + Anastrazole 1mg x 7 days
11032579|NCT01215292|OG000|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|
11032580|NCT01215292|OG001|Outcome|Acyline + Tgel + Ketoconazole 400mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
11032581|NCT01215292|OG002|Outcome|Acyline + Tgel + Ketoconazole 800mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
11032582|NCT01215292|EG000|Reported Event|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
10887063|NCT00498602|OG002|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032583|NCT01215292|EG001|Reported Event|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
11032584|NCT01215292|EG002|Reported Event|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
11032585|NCT01215292|EG003|Reported Event|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
11032586|NCT01215292|EG004|Reported Event|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
11032587|NCT01215318|BG000|Baseline|Modified Vaginal Tampons|Patients wearing modified vaginal tampons during PET/CT
11032588|NCT01215318|BG001|Baseline|Unmodified Vaginal Tampons|Patients wearing unmodified vaginal tampons during PET/CT
11032589|NCT01215318|BG002|Baseline|Total|Total of all reporting groups
11032590|NCT01215318|FG000|Participant Flow|Modified Vaginal Tampons|Patients wearing modified tampons during PET/CT
11032591|NCT01215318|FG001|Participant Flow|Unmodified Vaginal Tampons|Patients wearing unmodified vaginal tampons during FDG PET/CT
11032592|NCT01215318|OG000|Outcome|Modified Vaginal Tampons|Patients wearing modified tampons during FDG PET/CT
11032593|NCT01215318|OG001|Outcome|Unmodified Vaginal Tampons|Patients wearing unmodified tampons during FDG PET/CT
11032594|NCT01215318|OG000|Outcome|Modified Vaginal Tampons|Patients wearing modified vaginal tampon during PET/CT
11032595|NCT01215318|OG001|Outcome|Unmodified Vaginal Tampons|Patients wearing modified vaginal tampon during PET/CT
11032596|NCT01215318|EG000|Reported Event|Modified Vaginal Tampons|Patients wearing modified vaginal tampon during PET/CT
11032597|NCT01215318|EG001|Reported Event|Unmodified Vaginal Tampons|Patients wearing unmodified vaginal tampon during PET/CT
11032598|NCT01215344|BG000|Baseline|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~Lenalidomide: 25 mg by mouth on days 1-4 of each cycle~Dexamethasone: 20 mg the day before and the day after receiving VELCADE~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
11032599|NCT01215344|BG001|Baseline|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle~Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
11032600|NCT01215344|BG002|Baseline|Total|Total of all reporting groups
11032601|NCT01215344|FG000|Participant Flow|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~Lenalidomide: 25 mg by mouth on days 1-4 of each cycle~Dexamethasone: 20 mg the day before and the day after receiving VELCADE~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
11032602|NCT01215344|FG001|Participant Flow|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle~Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
11225852|NCT02370537|OG004|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
11032603|NCT01215344|OG000|Outcome|VELCADE, Lenalidomide, Dexamethasone (VRD)|"VELCADE, Lenalidomide, Dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~Lenalidomide: 25 mg by mouth on days 1-4 of each cycle~Dexamethasone: 20 mg the day before and the day after receiving VELCADE~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
11032604|NCT01215344|OG001|Outcome|VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)|"VELCADE, liposomal doxorubicin, dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle~Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
11032605|NCT01215344|OG000|Outcome|MRD Negative at Day 100|Patients with MRD status negative at day 100 (post-AHCT). They have MRD negative or positve at EOI.
11032606|NCT01215344|OG001|Outcome|MRD Status Positive at Day 100 (Post-AHCT)|Patients with MRD status stay positive at both EOI and day 100.
11032607|NCT01215344|EG000|Reported Event|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~Lenalidomide: 25 mg by mouth on days 1-4 of each cycle~Dexamethasone: 20 mg the day before and the day after receiving VELCADE~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
11032608|NCT01215344|EG001|Reported Event|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle~Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
11032609|NCT01215357|BG000|Baseline|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
11032610|NCT01215357|FG000|Participant Flow|Ecopipam (50 or 100 mg, as Needed)|Patients were instructed to take a 50 mg tablet each time they had an urge to gamble. If that was ineffective, they were instructed to take a second 50 mg tablet. If that was ineffective, they were not allowed to increase the dose further.
11032611|NCT01215357|OG000|Outcome|Ecopipam 50 mg or 100 mg as Needed|Patients were instructed to take one 50 mg tablet of ecopipam when they had an urge to gamble. If this was effective, they should not take any more drug. If it was not effective, they were permitted to take a second 50 mg tablet of ecopipam. If this was effective, they should not take any more drug. If this was not effective, they were not permitted to take any additional ecopipam.
11349052|NCT04128293|EG000|Reported Event|Treatment A- GSK3640254 200 mg Capsules (Fed)|Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
11032612|NCT01215357|EG000|Reported Event|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
11032613|NCT01215422|BG000|Baseline|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
11032614|NCT01215422|BG001|Baseline|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
10887064|NCT00498602|OG003|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032615|NCT01215422|BG002|Baseline|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
11032616|NCT01215422|BG003|Baseline|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
11032617|NCT01215422|BG004|Baseline|Total|Total of all reporting groups
11032618|NCT01215422|FG000|Participant Flow|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
11032619|NCT01215422|FG001|Participant Flow|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice.
11032620|NCT01215422|FG002|Participant Flow|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface DCI (KS) VLS
11032621|NCT01215422|FG003|Participant Flow|GS Intubation Participants|Children intubated with the GlideScope system (GS) VLS
11032622|NCT01215422|OG000|Outcome|GS Intubations|Anesthesiologists who performed minimum 18 intubations with the GS VLS.
11032623|NCT01215422|OG001|Outcome|KS Intubations|Anesthesiologists who performed minimum 18 intubations with the KS VLS
11032624|NCT01215422|OG000|Outcome|GS Intubation Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
11032625|NCT01215422|OG001|Outcome|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
11032626|NCT01215422|OG002|Outcome|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
11032627|NCT01215422|OG000|Outcome|GS Intubation Times for Those Who Used GS First|
11032628|NCT01215422|OG001|Outcome|KS Intubation Times for Those Who Used KS First|
11032629|NCT01215422|OG002|Outcome|GS Intubation Times for Those Who Used KS First|
11032630|NCT01215422|OG003|Outcome|KS Intubation Times for Those Who Used GS First|
11225853|NCT02370537|OG005|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
11225854|NCT02370537|EG000|Reported Event|Low FEC (EPANOVA®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
11032631|NCT01215422|OG000|Outcome|GS Intubation Participants|Children successfully intubated with the GlideScope system (GS) video laryngoscope (VLS)
11032632|NCT01215422|OG001|Outcome|KS Intubation Participants|Children successfully intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
11032633|NCT01215422|OG002|Outcome|Baseline Intubation Participants|Children intubated with the standard laryngoscope of the anesthesiologist's choice
11032634|NCT01215422|OG000|Outcome|Randomized to GS First|
11032635|NCT01215422|OG001|Outcome|Randomized to KS First|
11032636|NCT01215422|OG000|Outcome|GS Intubations|Anesthesiologists who intubated minimum 18 children with the GS VLS.
11032637|NCT01215422|OG001|Outcome|KS Intubations|Anesthesiologists who intubated minimum 18 children with the KS VLS
11032638|NCT01215422|EG000|Reported Event|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
11032639|NCT01215422|EG001|Reported Event|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
11032640|NCT01215422|EG002|Reported Event|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
11032641|NCT01215422|EG003|Reported Event|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
11032642|NCT01215435|BG000|Baseline|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
11032643|NCT01215435|BG001|Baseline|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
11032644|NCT01215435|BG002|Baseline|Total|Total of all reporting groups
11032645|NCT01215435|FG000|Participant Flow|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
11032646|NCT01215435|FG001|Participant Flow|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
11032647|NCT01215435|OG000|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
11032648|NCT01215435|OG001|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
11032649|NCT01215435|EG000|Reported Event|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
11349053|NCT04128293|EG001|Reported Event|Treatment B- GSK3640254 200 mg Tablet (Fed)|Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
11032650|NCT01215435|EG001|Reported Event|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
11032651|NCT01215513|BG000|Baseline|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
11032652|NCT01215513|FG000|Participant Flow|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
11032653|NCT01215513|OG000|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
11032654|NCT01215513|OG000|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
11032655|NCT01215513|EG000|Reported Event|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
11032656|NCT01215643|BG000|Baseline|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
11032657|NCT01215643|BG001|Baseline|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
11032658|NCT01215643|BG002|Baseline|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
11032659|NCT01215643|BG003|Baseline|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
11032660|NCT01215643|BG004|Baseline|PEG+RBV|PEG and RBV during Weeks 1 to 24.
11032661|NCT01215643|BG005|Baseline|Total|Total of all reporting groups
11032662|NCT01215643|FG000|Participant Flow|ALV 1000 mg|Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
11032663|NCT01215643|FG001|Participant Flow|ALV 600 mg+RBV|ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
11032664|NCT01215643|FG002|Participant Flow|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
11032665|NCT01215643|FG003|Participant Flow|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with peginterferon alfa-2a (PEG) during Weeks 2 to 24.
11032666|NCT01215643|FG004|Participant Flow|PEG+RBV|PEG and RBV during Weeks 1 to 24.
11032667|NCT01215643|OG000|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
11032668|NCT01215643|OG001|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
11032669|NCT01215643|OG002|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
11032670|NCT01215643|OG003|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
11032671|NCT01215643|OG004|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
11032672|NCT01215643|EG000|Reported Event|ALV 1000 mg: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
11032673|NCT01215643|EG001|Reported Event|ALV 600 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
11032674|NCT01215643|EG002|Reported Event|ALV 800 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
11032675|NCT01215643|EG003|Reported Event|ALV 600 mg+PEG: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
11032676|NCT01215643|EG004|Reported Event|PEG+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24.
11032677|NCT01215643|EG005|Reported Event|ALV 1000 mg: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
11032678|NCT01215643|EG006|Reported Event|ALV 600 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
11032679|NCT01215643|EG007|Reported Event|ALV 800 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
11032680|NCT01215643|EG008|Reported Event|ALV 600 mg+PEG: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
11032681|NCT01215643|EG009|Reported Event|PEG+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
11032682|NCT01215695|BG000|Baseline|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
11032683|NCT01215695|BG001|Baseline|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
11032684|NCT01215695|BG002|Baseline|Total|Total of all reporting groups
11032685|NCT01215695|FG000|Participant Flow|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
11032686|NCT01215695|FG001|Participant Flow|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
11032687|NCT01215695|OG000|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
11032688|NCT01215695|OG001|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
11032689|NCT01215695|EG000|Reported Event|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
11032690|NCT01215695|EG001|Reported Event|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
11032691|NCT01215721|BG000|Baseline|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
11032692|NCT01215721|FG000|Participant Flow|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
11032693|NCT01215721|OG000|Outcome|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
11032694|NCT01215721|EG000|Reported Event|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
11032695|NCT01215734|BG000|Baseline|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
11032696|NCT01215734|BG001|Baseline|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
11032697|NCT01215734|BG002|Baseline|Total|Total of all reporting groups
11032698|NCT01215734|FG000|Participant Flow|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
11032699|NCT01215734|FG001|Participant Flow|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
11032700|NCT01215734|OG000|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
11032701|NCT01215734|OG001|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
11032702|NCT01215734|EG000|Reported Event|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
11032703|NCT01215734|EG001|Reported Event|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
11032704|NCT01215786|BG000|Baseline|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
11032705|NCT01215786|BG001|Baseline|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
11032706|NCT01215786|BG002|Baseline|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
11032707|NCT01215786|BG003|Baseline|Total|Total of all reporting groups
11032708|NCT01215786|FG000|Participant Flow|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
11032709|NCT01215786|FG001|Participant Flow|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
11032710|NCT01215786|FG002|Participant Flow|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
11032711|NCT01215786|OG000|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
11032712|NCT01215786|OG001|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
11032713|NCT01215786|OG002|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
11032714|NCT01215786|EG000|Reported Event|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
11032715|NCT01215786|EG001|Reported Event|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
11032716|NCT01215786|EG002|Reported Event|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
11032717|NCT01215851|BG000|Baseline|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
11032718|NCT01215851|BG001|Baseline|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
11032719|NCT01215851|BG002|Baseline|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
10887065|NCT00498602|OG004|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032720|NCT01215851|BG003|Baseline|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets and pyrazinamide administered once daily in 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
11032721|NCT01215851|BG004|Baseline|Rifafour e-275 mg|Rifafour e-275 administered once daily with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
11032722|NCT01215851|BG005|Baseline|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
11032723|NCT01215851|BG006|Baseline|Total|Total of all reporting groups
11032724|NCT01215851|FG000|Participant Flow|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
11032725|NCT01215851|FG001|Participant Flow|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
11032726|NCT01215851|FG002|Participant Flow|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
11032727|NCT01215851|FG003|Participant Flow|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
11032728|NCT01215851|FG004|Participant Flow|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
10887066|NCT00498602|OG005|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032729|NCT01215851|FG005|Participant Flow|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
11032730|NCT01215851|OG000|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
11032731|NCT01215851|OG001|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
11032732|NCT01215851|OG002|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
11032733|NCT01215851|OG003|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
11032734|NCT01215851|OG004|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
11032735|NCT01215851|OG005|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
11032736|NCT01215851|OG001|Outcome|TMC207 and Pyrazinamide|MC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
11032737|NCT01215851|EG000|Reported Event|TMC207|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide placebo
11032738|NCT01215851|EG001|Reported Event|TMC207 and Pyrazinamide|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide (dosed by weight)
11032739|NCT01215851|EG002|Reported Event|PA-824 and Pyrazinamide|PA-824 200mg and pyrazinamide (dosed by weight)and moxifloxacin placebo
11032740|NCT01215851|EG003|Reported Event|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 200 mg and pyrazinamide (dosed by weight) and moxifloxacin 400 mg
11032741|NCT01215851|EG004|Reported Event|Rifafour e-275 mg|Rifafour e-275 275 mg
11032742|NCT01215851|EG005|Reported Event|TMC207 and PA-824|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 200 mg
11225855|NCT02370537|EG001|Reported Event|Low FEC (OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
11032743|NCT01215916|BG000|Baseline|LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032744|NCT01215916|BG001|Baseline|LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032745|NCT01215916|BG002|Baseline|LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032746|NCT01215916|BG003|Baseline|LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032747|NCT01215916|BG004|Baseline|LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032748|NCT01215916|BG005|Baseline|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032749|NCT01215916|BG006|Baseline|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met
11032750|NCT01215916|BG007|Baseline|Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4|Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
10887067|NCT00498602|OG006|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032751|NCT01215916|BG008|Baseline|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032752|NCT01215916|BG009|Baseline|Total|Total of all reporting groups
11032753|NCT01215916|FG000|Participant Flow|LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11225856|NCT02370537|EG002|Reported Event|Intermediate FEC (EPANOVA®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
11032754|NCT01215916|FG001|Participant Flow|LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032755|NCT01215916|FG002|Participant Flow|LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032756|NCT01215916|FG003|Participant Flow|LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032757|NCT01215916|FG004|Participant Flow|LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032758|NCT01215916|FG005|Participant Flow|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032759|NCT01215916|FG006|Participant Flow|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032760|NCT01215916|FG007|Participant Flow|Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4|Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032761|NCT01215916|FG008|Participant Flow|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032762|NCT01215916|OG000|Outcome|Pemetrexed Followed by LY573636|"Pemetrexed on Day 1 and LY573636 on Day 4.~LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 micrograms per milliliter (ug/mL) up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.~Pemetrexed: 375 milligrams per square meter (mg/m^2) to 500 mg/m^2; intravenous dosing was completed once each 28-day cycle.~Participants were pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent].~Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11066441|NCT01392378|EG000|Reported Event|13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
11349054|NCT04128293|EG002|Reported Event|Treatment C- GSK3640254 200 mg Tablet (Fasted)|Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.
10887068|NCT00498602|EG000|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032763|NCT01215916|OG001|Outcome|LY573636 Followed by Pemetrexed|"LY573636 on Day 1 and pemetrexed on Day 4.~LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.~Pemetrexed: 375 mg/m^2 to 500 mg/m^2; intravenous dosing was completed once each 28-day cycle.~Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).~Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11032764|NCT01215916|OG002|Outcome|LY573636 and Pemetrexed on Day 1|"LY573636 and pemetrexed on Day 1.~LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 21-day cycle.~Pemetrexed: 375 mg/m^2 to 500 mg/m^2. Intravenous dosing was completed once each 21-day cycle.~Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).~Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
11032765|NCT01215916|OG000|Outcome|LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032766|NCT01215916|OG001|Outcome|LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032767|NCT01215916|OG002|Outcome|LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032768|NCT01215916|OG003|Outcome|LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032769|NCT01215916|OG004|Outcome|LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032770|NCT01215916|OG005|Outcome|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032771|NCT01215916|OG006|Outcome|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11225857|NCT02370537|EG003|Reported Event|Intermediate FEC (OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
11225858|NCT02370537|EG004|Reported Event|Normal FEC (EPANOVA®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
11032772|NCT01215916|OG007|Outcome|Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4|Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032773|NCT01215916|OG008|Outcome|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032774|NCT01215916|OG000|Outcome|All Enrolled Participants|Participants who received 1 or more doses of LY573636.
11032775|NCT01215916|EG000|Reported Event|LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day1|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032776|NCT01215916|EG001|Reported Event|LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032777|NCT01215916|EG002|Reported Event|LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032778|NCT01215916|EG003|Reported Event|LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032779|NCT01215916|EG004|Reported Event|LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4|Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032780|NCT01215916|EG005|Reported Event|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032781|NCT01215916|EG006|Reported Event|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032782|NCT01215916|EG007|Reported Event|Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4|Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11066442|NCT01392378|EG001|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
11032783|NCT01215916|EG008|Reported Event|Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4|Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
11032784|NCT01215929|BG000|Baseline|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
11225859|NCT02370537|EG005|Reported Event|Normal FEC (OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
11032785|NCT01215929|BG001|Baseline|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
11032786|NCT01215929|BG002|Baseline|Total|Total of all reporting groups
11032787|NCT01215929|FG000|Participant Flow|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
11032788|NCT01215929|FG001|Participant Flow|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
11032789|NCT01215929|OG000|Outcome|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
11032790|NCT01215929|OG001|Outcome|Placebo|Placebo: Thirty-five treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
11032791|NCT01215929|EG000|Reported Event|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
11032792|NCT01215929|EG001|Reported Event|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
11032793|NCT01215942|BG000|Baseline|120 mg LY2127399 (LY A)|"120 mg LY2127399 administered SC Q4W.~Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment."
11032794|NCT01215942|BG001|Baseline|90 mg LY2127399 (LY B)|"90 mg LY2127399 administered SC Q2W.~Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment."
11032795|NCT01215942|BG002|Baseline|Total|Total of all reporting groups
11032796|NCT01215942|FG000|Participant Flow|120 mg LY2127399 (LY A)|"120 milligrams (mg) LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W).~Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study H9B-MC-BCDP (BCDP) enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment."
11225860|NCT02370602|BG000|Baseline|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
11225861|NCT02370602|BG001|Baseline|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11032797|NCT01215942|FG001|Participant Flow|90 mg LY2127399 (LY B)|"90 mg LY2127399 administered SC every 2 weeks (Q2W).~Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment."
11032798|NCT01215942|OG000|Outcome|120 mg LY2127399 (LY A)|"120 mg LY2127399 administered SC Q4W.~Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment."
11032799|NCT01215942|OG001|Outcome|90 mg LY2127399 (LY B)|"90 mg LY2127399 administered SC Q2W.~Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment."
11032800|NCT01215942|OG000|Outcome|LY A|"120 mg LY2127399 administered SC Q4W (LY A).~All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV."
11032801|NCT01215942|OG001|Outcome|LY B|"90 mg LY2127399 administered SC Q2W (LY B).~All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV."
11032802|NCT01215942|OG002|Outcome|NR LY A to LY B|"90 mg LY2127399 administered SC Q2W.~All Week 16 non-responders (NR) from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV."
11032803|NCT01215942|OG003|Outcome|NR LY B to LY B|"90 mg LY2127399 administered SC Q2W.~All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV."
11032804|NCT01215942|OG004|Outcome|NR Placebo to LY B|"90 mg LY2127399 administered SC Q2W.~All Week 16 NR from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV."
11032805|NCT01215942|OG005|Outcome|Placebo to LY A|"120 mg LY2127399 administered SC Q4W (240 mg LY2127399 loading dose at Week 0).~All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 120 mg LY2127399 SC Q4W in Study BCDP."
11032806|NCT01215942|OG006|Outcome|Placebo to LY B|"90 mg LY2127399 administered SC Q2W (180 mg LY2127399 loading dose at Week 0).~All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 90 mg LY2127399 SC Q2W in Study BCDP."
11032807|NCT01215942|OG002|Outcome|NR LY A to LY B|"90 mg LY2127399 administered SC Q2W.~All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV."
11032808|NCT01215942|OG001|Outcome|LY B|90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
11032809|NCT01215942|EG000|Reported Event|120 mg LY2127399 (LY A) Treatment Period|"120 mg LY2127399 administered SC Q4W.~Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment."
11032810|NCT01215942|EG001|Reported Event|90 mg LY2127399 (LY B) Treatment Period|"90 mg LY2127399 administered SC Q2W.~Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment."
10887069|NCT00498602|EG001|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032811|NCT01215942|EG002|Reported Event|120 mg LY2127399 (LY A) Follow-Up Period|"The Post-Treatment Follow-Up Period was defined as the time after study treatment discontinuation visit up to 48 weeks following the last injection of study treatment.~Includes Participants who were previously enrolled in Studies BCDO, BCDV and BCDM and who received 120 mg LY2127399 SC Q4W during Study BCDP treatment period."
11032812|NCT01215942|EG003|Reported Event|90 mg LY2127399 (LY B) Follow-Up Period|"The Post-Treatment Follow-Up Period was defined as the time after study treatment discontinuation visit up to 48 weeks following the last injection of study treatment.~Includes Participants who were previously enrolled in Studies BCDO, BCDV and BCDM and who received 90 mg LY2127399 SC Q2W during Study BCDP treatment period."
11032813|NCT01215955|BG000|Baseline|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11032814|NCT01215955|BG001|Baseline|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based dose was on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11349055|NCT04128293|EG003|Reported Event|Treatment D- GSK3640254 200 mg Tablet (High Fat)|Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
11032815|NCT01215955|BG002|Baseline|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032816|NCT01215955|BG003|Baseline|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032817|NCT01215955|BG004|Baseline|Total|Total of all reporting groups
11032818|NCT01215955|FG000|Participant Flow|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11032819|NCT01215955|FG001|Participant Flow|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11032820|NCT01215955|FG002|Participant Flow|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032821|NCT01215955|FG003|Participant Flow|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032822|NCT01215955|OG000|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11032823|NCT01215955|OG001|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11032824|NCT01215955|OG002|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032825|NCT01215955|OG003|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032826|NCT01215955|OG000|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11032827|NCT01215955|OG002|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032828|NCT01215955|OG003|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032829|NCT01215955|EG000|Reported Event|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11225862|NCT02370602|BG002|Baseline|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11032830|NCT01215955|EG001|Reported Event|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
11032831|NCT01215955|EG002|Reported Event|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032832|NCT01215955|EG003|Reported Event|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
11032833|NCT01215968|BG000|Baseline|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
11032834|NCT01215968|BG001|Baseline|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
11032835|NCT01215968|BG002|Baseline|Total|Total of all reporting groups
11032836|NCT01215968|FG000|Participant Flow|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
11032837|NCT01215968|FG001|Participant Flow|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
11032838|NCT01215968|OG000|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
11032839|NCT01215968|OG001|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
11032840|NCT01215968|OG001|Outcome|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
11032841|NCT01215968|OG002|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
11032842|NCT01215968|EG000|Reported Event|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
11032843|NCT01215968|EG001|Reported Event|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
11032844|NCT01215968|EG002|Reported Event|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
11032845|NCT01215981|BG000|Baseline|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
11032846|NCT01215981|BG001|Baseline|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
10887070|NCT00498602|EG002|Reported Event|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11032847|NCT01215981|BG002|Baseline|Total|Total of all reporting groups
11032848|NCT01215981|FG000|Participant Flow|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
11032849|NCT01215981|FG001|Participant Flow|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
11032850|NCT01215981|OG000|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
11032851|NCT01215981|OG001|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
11032852|NCT01215981|EG000|Reported Event|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
11032853|NCT01215981|EG001|Reported Event|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
11032854|NCT01216072|BG000|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
11032855|NCT01216072|BG001|Baseline|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
11032856|NCT01216072|BG002|Baseline|Total|Total of all reporting groups
11032857|NCT01216072|FG000|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
11032858|NCT01216072|FG001|Participant Flow|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
11032859|NCT01216072|OG000|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
11032860|NCT01216072|OG001|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
11032861|NCT01216072|OG001|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
11032862|NCT01216072|OG002|Outcome|Extension Fingolimod Period|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
11032863|NCT01216072|EG000|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
11032864|NCT01216072|EG001|Reported Event|Standard MS DMT|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
11032865|NCT01216072|EG002|Reported Event|Fingolimod Extension Phase|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
11032866|NCT01216163|BG000|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
11032867|NCT01216163|BG001|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
11032868|NCT01216163|BG002|Baseline|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
11032869|NCT01216163|BG003|Baseline|Total|Total of all reporting groups
11032870|NCT01216163|FG000|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
11032871|NCT01216163|FG001|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
11032872|NCT01216163|FG002|Participant Flow|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
11032873|NCT01216163|OG000|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
11032874|NCT01216163|OG001|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
11032875|NCT01216163|OG002|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
11032876|NCT01216163|EG000|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
11032877|NCT01216163|EG001|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
11032878|NCT01216163|EG002|Reported Event|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
11032879|NCT01216176|BG000|Baseline|Phase 1 - Cohort A|"Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer~Anastrozole~AZD0530"
11032880|NCT01216176|BG001|Baseline|Phase 2 - Cohort B [Anastrozole + AZD0530]|"Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed.~Anastrozole~AZD0530"
11032881|NCT01216176|BG002|Baseline|Phase 2 - Cohort B [Anastrozole + Placebo]|"Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed.~Anastrozole~Placebo"
11032882|NCT01216176|BG003|Baseline|Total|Total of all reporting groups
11032883|NCT01216176|FG000|Participant Flow|Phase 1 - Cohort A|"Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer~Anastrozole~AZD0530"
11032884|NCT01216176|FG001|Participant Flow|Phase 2 - Cohort B [Anastrozole + AZD0530]|"Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed.~Anastrozole~AZD0530"
11032885|NCT01216176|FG002|Participant Flow|Phase 2 - Cohort B [Anastrozole + Placebo]|"Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed.~Anastrozole~Placebo"
11032886|NCT01216176|OG000|Outcome|Phase 1 - Cohort A|"Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer~Anastrozole~AZD0530"
11032887|NCT01216176|OG000|Outcome|Phase 2 - Cohort B [Anastrozole + AZD0530]|"Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed.~Anastrozole~AZD0530"
11032888|NCT01216176|OG001|Outcome|Phase 2 - Cohort B [Anastrozole + Placebo]|"Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed.~Anastrozole~Placebo"
11032889|NCT01216176|OG000|Outcome|Phase 1 - Cohort A|"Dual treatment with 1 mg anastrozole orally once daily given for 7 days followed by anastrozole 1 mg orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer.~Anastrozole~AZD0530"
11032890|NCT01216176|EG000|Reported Event|Phase 1 - Cohort A|"Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer~Anastrozole~AZD0530"
11032891|NCT01216176|EG001|Reported Event|Phase 2 - Cohort B [Anastrozole + AZD0530]|"Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed.~Anastrozole~AZD0530"
11032892|NCT01216176|EG002|Reported Event|Phase 2 - Cohort B [Anastrozole + Placebo]|"Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed.~Anastrozole~Placebo"
11032893|NCT01216189|BG000|Baseline|Preoperative Radiotherapy|Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
11032894|NCT01216189|BG001|Baseline|No Preoperative Radiotherapy|Women with rectal cancer treated with surgery alone (no RT).
11032895|NCT01216189|BG002|Baseline|Total|Total of all reporting groups
11032896|NCT01216189|FG000|Participant Flow|Preoperative Radiotherapy|Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
11032897|NCT01216189|FG001|Participant Flow|No Preoperative Radiotherapy|Women with rectal cancer treated with surgery alone (no RT).
11032898|NCT01216189|OG000|Outcome|Preoperative Radiotherapy|Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
11032899|NCT01216189|OG001|Outcome|No Preoperative Radiotherapy|Women with rectal cancer treated with surgery alone (no RT).
11032900|NCT01216189|EG000|Reported Event|Preoperative RT|Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
11032901|NCT01216189|EG001|Reported Event|No Preoperative RT|Women with rectal cancer treated with surgery alone (no RT).
11032902|NCT01216202|BG000|Baseline|Preoperative RT|Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
11032903|NCT01216202|BG001|Baseline|No Preoperative RT|Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
11032904|NCT01216202|BG002|Baseline|Total|Total of all reporting groups
11032905|NCT01216202|FG000|Participant Flow|Preoperative RT|Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
11032906|NCT01216202|FG001|Participant Flow|No Preoperative RT|Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
11032907|NCT01216202|OG000|Outcome|Preoperative RT|Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
11032908|NCT01216202|OG001|Outcome|No Preoperative RT|Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
11032909|NCT01216202|OG000|Outcome|Preoperative RT|Men with rectal cancer treated with preoperative therapy (RT) and surgery with available semen samples.
11032910|NCT01216202|OG001|Outcome|No Preoperative RT|Men with rectal cancer treated with surgery alone (no RT) with available semen samples.
11032911|NCT01216202|EG000|Reported Event|Preoperative RT|Men with rectal cancer treated with preoperative therapy (RT) and surgery.
11032912|NCT01216202|EG001|Reported Event|No Preoperative RT|Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
11032913|NCT01216241|BG000|Baseline|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
11032914|NCT01216241|BG001|Baseline|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
11032915|NCT01216241|BG002|Baseline|Total|Total of all reporting groups
11032916|NCT01216241|FG000|Participant Flow|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
11032917|NCT01216241|FG001|Participant Flow|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
11032918|NCT01216241|OG000|Outcome|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
11032919|NCT01216241|OG001|Outcome|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
11032920|NCT01216241|EG000|Reported Event|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
11032921|NCT01216241|EG001|Reported Event|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
11032922|NCT01216319|BG000|Baseline|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
11032923|NCT01216319|FG000|Participant Flow|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
11032924|NCT01216319|OG000|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
11032925|NCT01216319|EG000|Reported Event|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
11032926|NCT01216332|BG000|Baseline|High-Dose Trivalent Inactivated Influenza Vaccine|"0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.~High-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine."
11032927|NCT01216332|BG001|Baseline|Standard Dose Trivalent Inactivated Influenza Vaccine|"0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine~Standard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine"
11032928|NCT01216332|BG002|Baseline|Total|Total of all reporting groups
11032929|NCT01216332|FG000|Participant Flow|High-Dose Trivalent Inactivated Influenza Vaccine|0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.
11032930|NCT01216332|FG001|Participant Flow|Standard Dose Trivalent Inactivated Influenza Vaccine|0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine
11032931|NCT01216332|OG000|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|"0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.~High-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine."
11032932|NCT01216332|OG001|Outcome|Standard Dose Trivalent Inactivated Influenza Vaccine|"0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine~Standard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine"
11032933|NCT01216332|EG000|Reported Event|High-Dose Trivalent Inactivated Influenza Vaccine|"0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.~High-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine."
11032934|NCT01216332|EG001|Reported Event|Standard Dose Trivalent Inactivated Influenza Vaccine|"0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine~Standard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine"
11032935|NCT01216397|BG000|Baseline|All Participants|Treatment with standard batch and side batch
11032936|NCT01216397|FG000|Participant Flow|Standard Batch Then Side Batch|Linagliptin/metformin FDC tablet from standard batch, then Linagliptin/metformin FDC tablet from side batch
11032937|NCT01216397|FG001|Participant Flow|Side Batch Then Standard Batch|Linagliptin/metformin FDC tablet from side batch, then Linagliptin/metformin FDC tablet from standard batch
11032938|NCT01216397|OG000|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
11032939|NCT01216397|OG001|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
11032940|NCT01216397|EG000|Reported Event|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
11032941|NCT01216397|EG001|Reported Event|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
11032942|NCT01216410|BG000|Baseline|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
11032943|NCT01216410|BG001|Baseline|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
11032944|NCT01216410|BG002|Baseline|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
11032945|NCT01216410|BG003|Baseline|Total|Total of all reporting groups
11032946|NCT01216410|FG000|Participant Flow|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
11032947|NCT01216410|FG001|Participant Flow|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
11032948|NCT01216410|FG002|Participant Flow|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
11032949|NCT01216410|OG000|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
11032950|NCT01216410|OG001|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
11032951|NCT01216410|OG002|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
11032952|NCT01216410|EG000|Reported Event|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
11032953|NCT01216410|EG001|Reported Event|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
11032954|NCT01216410|EG002|Reported Event|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
11032955|NCT01216735|BG000|Baseline|Smokers|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
11032956|NCT01216735|BG001|Baseline|Non-smokers|this group served as controls for baseline data. No intervention or treatment were assigned to this group.
11032957|NCT01216735|BG002|Baseline|Total|Total of all reporting groups
11032958|NCT01216735|FG000|Participant Flow|Fluticasone First, Then Placebo|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
11032959|NCT01216735|FG001|Participant Flow|Placebo First, Then Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
11032960|NCT01216735|OG000|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
11032961|NCT01216735|OG001|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Placebo: Placebo MDI"
11032962|NCT01216735|EG000|Reported Event|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day for 3 weeks~Placebo: Placebo for 3 weeks"
11032963|NCT01216735|EG001|Reported Event|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day for 3 weeks~Placebo: Placebo for 3 weeks"
11032964|NCT01216748|BG000|Baseline|Controls|health-lifetime non-smokers were enrolled
11032965|NCT01216748|FG000|Participant Flow|All Study Participants|healthy lifetime non smokers were challenged with 4 respiratory manouvers: quiet breathing, hypocapnic hyperventilation, hypercapnic hyperventilation, and eucapnic hyperventilation in random order.
11032966|NCT01216748|OG000|Outcome|Health Controls|Health lifetime non smokers were recruited.
11032967|NCT01216748|EG000|Reported Event|Health Controls|Health lifetime non smokers were recruited.
11032968|NCT01216761|BG000|Baseline|Total Population|
11032969|NCT01216761|FG000|Participant Flow|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
11032970|NCT01216761|FG001|Participant Flow|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
11032971|NCT01216761|FG002|Participant Flow|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
11032972|NCT01216761|OG000|Outcome|Chlorhexidine Gluconate (CHG_|2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
11032973|NCT01216761|OG001|Outcome|Iodine Tincture (IT)|Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
11032974|NCT01216761|OG002|Outcome|Povidone Iodine (PI)|10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
11032975|NCT01216761|EG000|Reported Event|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
11032976|NCT01216761|EG001|Reported Event|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
11032977|NCT01216761|EG002|Reported Event|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
11032978|NCT01216943|BG000|Baseline|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
11032979|NCT01216943|FG000|Participant Flow|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
11032980|NCT01216943|OG000|Outcome|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
11225863|NCT02370602|BG003|Baseline|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
11032981|NCT01216943|EG000|Reported Event|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
11032982|NCT01217073|BG000|Baseline|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
11032983|NCT01217073|BG001|Baseline|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
11032984|NCT01217073|BG002|Baseline|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
11032985|NCT01217073|BG003|Baseline|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
11032986|NCT01217073|BG004|Baseline|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
11032987|NCT01217073|BG005|Baseline|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
11032988|NCT01217073|BG006|Baseline|Total|Total of all reporting groups
11032989|NCT01217073|FG000|Participant Flow|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
11032990|NCT01217073|FG001|Participant Flow|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
11032991|NCT01217073|FG002|Participant Flow|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
11032992|NCT01217073|FG003|Participant Flow|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
11032993|NCT01217073|FG004|Participant Flow|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
11032994|NCT01217073|FG005|Participant Flow|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
11032995|NCT01217073|FG006|Participant Flow|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)
11032996|NCT01217073|FG007|Participant Flow|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
11032997|NCT01217073|OG000|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
11032998|NCT01217073|OG001|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
11032999|NCT01217073|OG002|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
11033000|NCT01217073|OG003|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
11033001|NCT01217073|OG004|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
11033002|NCT01217073|OG005|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
11033003|NCT01217073|OG000|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
11033004|NCT01217073|OG001|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
11033005|NCT01217073|OG000|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
11033006|NCT01217073|OG001|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
11033007|NCT01217073|OG002|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
11033008|NCT01217073|OG003|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
11033009|NCT01217073|OG004|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
11033010|NCT01217073|OG005|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
11033011|NCT01217073|EG000|Reported Event|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
11033012|NCT01217073|EG001|Reported Event|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
11225864|NCT02370602|BG004|Baseline|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11033013|NCT01217073|EG002|Reported Event|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
11033014|NCT01217073|EG003|Reported Event|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
11033015|NCT01217073|EG004|Reported Event|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
11033016|NCT01217073|EG005|Reported Event|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
11033017|NCT01217073|EG006|Reported Event|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
11033018|NCT01217073|EG007|Reported Event|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
11033019|NCT01217112|BG000|Baseline|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
11033020|NCT01217112|BG001|Baseline|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
11033021|NCT01217112|BG002|Baseline|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
11033022|NCT01217112|BG003|Baseline|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
11033023|NCT01217112|BG004|Baseline|Placebo|Contains excipients only
11033024|NCT01217112|BG005|Baseline|Total|Total of all reporting groups
11033025|NCT01217112|FG000|Participant Flow|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
11033026|NCT01217112|FG001|Participant Flow|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
11033027|NCT01217112|FG002|Participant Flow|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
11033028|NCT01217112|FG003|Participant Flow|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
11033029|NCT01217112|FG004|Participant Flow|Placebo|Contains excipients only
11033030|NCT01217112|OG000|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
11033031|NCT01217112|OG001|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
11033032|NCT01217112|OG002|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
11033033|NCT01217112|OG003|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
11033034|NCT01217112|OG004|Outcome|Placebo|Contains excipients only
11033035|NCT01217112|EG000|Reported Event|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
11033036|NCT01217112|EG001|Reported Event|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
11033037|NCT01217112|EG002|Reported Event|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
11033038|NCT01217112|EG003|Reported Event|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
11033039|NCT01217112|EG004|Reported Event|Placebo|Contains excipients only
11033040|NCT01217190|BG000|Baseline|Experimental: Ondansetron ODFS, Then Zofran ODT|24 participants completed treatment with Ondansetron ODSF 8 mg. After a washout period of 7 days, 24 of the 24 participants who completed the first treatment also completed treatment with Zofran ODT 8mg.
11033041|NCT01217190|BG001|Baseline|Experimental: Zofran ODT, Then Ondansetron ODFS|24 participants completed treatment with Zofran ODT 8 mg. After a washout period of 7 days, 22 of the 24 participants who completed the first treatment also completed treatment with Ondansetron ODSF 8 mg
11033042|NCT01217190|BG002|Baseline|Total|Total of all reporting groups
11033043|NCT01217190|FG000|Participant Flow|Experimental: Ondansetron ODFS, Then Zofran ODT|Participants first received a single oral dose of Ondansetron Orally Dissolving Film Strip (ODFS) 8 mg after an overnight fast of at least 10 hours. After a washout period of 7 days, they then received a single oral dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg after an overnight fast of at least 10 hours.
11033044|NCT01217190|FG001|Participant Flow|Experimental: Zofran ODT, Then Ondansetron ODFS|Participants first received a single oral dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg after an overnight fast of at least 10 hours. After a washout period of 7 days, they then received a single oral dose of Ondansetron Oral Dissolving Film Strip (ODFS) 8 mg after an overnight fast of at least 10 hours.
11033045|NCT01217190|OG000|Outcome|Ondansetron ODFS|"Single dose of Ondansetron Orally Dissolving Film Strip (ODFS) 8 mg~ODFS:Two-way cross-over study to compare ODFS 8 mg with Zofran Orally Disintegrating Table (ODT) containing ondansetron 8 mg"
11033046|NCT01217190|OG001|Outcome|Zofran ODT|"Single dose of Zofran (Ondansetron) Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg~Zofran (ODT): Two-way cross-over study to compare ODFS 8 mg with Zofran ODT 8 mg"
11033047|NCT01217190|OG000|Outcome|Ondansetron ODFS|"Single dose of Ondansetron Orally Dissolving Film Strip 8 mg~Ondansetron (ODS): Two-wy cross-over study to compare ondansetron ODSF with Zofran ODT"
11033048|NCT01217190|OG001|Outcome|Zofran ODT|"Single dose of Zofran ODT® Orally Disintegrating Tablet 8 mg~Zofran (ODT): Two way cross-over study to compare ondansetron ODSF with Zofran ODT"
11033049|NCT01217190|OG001|Outcome|Zofran ODT|"Single dose of Zofran (Ondansetron) ODT® Orally Disintegrating Tablets 8 mg~Zofran (ODT): Two way cross-over study to compare ondansetron ODSF with Zofran ODT"
11033050|NCT01217190|EG000|Reported Event|Ondansetron ODFS|"Single dose of Ondansetron Orally Dissolving Film Strip (ODFS) 8 mg~ODFS: Two-way cross-over study to compare ODFS 8 mg with Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg"
11033051|NCT01217190|EG001|Reported Event|Zofran ODT|"Single dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg~Zofran ODT: Two-way cross-over study to compare ODFS 8 mg with Zofran ODT 8 mg"
11033052|NCT01217229|BG000|Baseline|PLX3397|Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
11033053|NCT01217229|FG000|Participant Flow|PLX3397|Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
11033054|NCT01217229|OG000|Outcome|PLX3397|Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
11033055|NCT01217229|EG000|Reported Event|PLX3397|Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
11033056|NCT01217307|BG000|Baseline|Metformin|"metformin 500mg twice daily during 4 months~Metformin: Metformin 500mg twice daily during 4 months"
11033057|NCT01217307|BG001|Baseline|Placebo|"Placebo twice daily during 4 months~Placebo: Placebo twice daily during 4 months"
10887071|NCT00498602|EG003|Reported Event|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11033058|NCT01217307|BG002|Baseline|Total|Total of all reporting groups
11033059|NCT01217307|FG000|Participant Flow|Metformin|"metformin 500mg twice daily during 4 months~Metformin: Metformin 500mg twice daily during 4 months"
11033060|NCT01217307|FG001|Participant Flow|Placebo|"Placebo twice daily during 4 months~Placebo: Placebo twice daily during 4 months"
11033061|NCT01217307|OG000|Outcome|Metformin|"metformin 500mg twice daily during 4 months~Metformin: Metformin 500mg twice daily during 4 months"
11033062|NCT01217307|OG001|Outcome|Placebo|"Placebo twice daily during 4 months~Placebo: Placebo twice daily during 4 months"
11033063|NCT01217307|EG000|Reported Event|Metformin|"metformin 500mg twice daily during 4 months~Metformin: Metformin 500mg twice daily during 4 months"
11033064|NCT01217307|EG001|Reported Event|Placebo|"Placebo twice daily during 4 months~Placebo: Placebo twice daily during 4 months"
11033065|NCT01217385|BG000|Baseline|Diffuse Optical Spectroscopy Imaging (DOSI)|"Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.~DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during neoadjuvant Chemotherapy (NAC) treatment."
11033066|NCT01217385|FG000|Participant Flow|Diffuse Optical Spectroscopy Imaging (DOSI)|"Participants undergo approximately four assessments of breast health using the Diffuse optical spectroscopy imaging (DOSI)technology during treatment and prior to surgery for breast cancer.~DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during neoadjuvant chemotherapy (NAC) treatment."
11033067|NCT01217385|OG000|Outcome|Diffuse Optical Spectroscopy Imaging (DOSI|"Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.~DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment."
11033068|NCT01217385|OG000|Outcome|PR+ Participants|Participants who are PR Positive (PR+)
11033069|NCT01217385|OG001|Outcome|PR- Participants|Participants who are Progesterone Receptor Negative (PR-)
11033070|NCT01217385|OG002|Outcome|PR? Participants|Participants whose PR status is unknown
11033071|NCT01217385|OG000|Outcome|StO2 Negative|Evaluable subjects with measurable baseline tumor oxygen saturation StO2 <= 76.9%. (i.e. population median)
11033072|NCT01217385|OG001|Outcome|StO2 Positive|Evaluable subjects with measurable baseline tumor oxygen saturation StO2 > 76.9%. (i.e. population median)
11033073|NCT01217385|OG000|Outcome|Diffuse Optical Spectroscopy Imaging (DOSI)|"Participants undergo approximately four assessments of breast health using the Diffuse optical spectroscopy imaging (DOSI)technology during treatment and prior to surgery for breast cancer.~DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during neoadjuvant chemotherapy (NAC) treatment."
11033074|NCT01217385|EG000|Reported Event|DOSI|"Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.~DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment."
11033075|NCT01217411|BG000|Baseline|Phase 1 Arm I (WBRT + R04929097)|Patients with >= 4 brain lesions undergo WBRT + R04929097 Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery
11033076|NCT01217411|BG001|Baseline|Phase 1 Arm II (SRS + RO4929097)|"Patients with =< 3 brain lesions receive RO4929097 and undergo SRS. For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality"
11033077|NCT01217411|BG002|Baseline|Total|Total of all reporting groups
11033078|NCT01217411|FG000|Participant Flow|Phase 1 Arm I (WBRT + R04929097)|"Patients with >= 4 brain lesions undergo WBRT + R04929097~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
11033079|NCT01217411|FG001|Participant Flow|Phase 1 Arm II (SRS + RO4929097)|"Patients with =< 3 brain lesions receive RO4929097 and undergo SRS. For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality"
11033080|NCT01217411|OG000|Outcome|Phase 1 Arm I|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT"
11033081|NCT01217411|OG000|Outcome|Phase I Arm II|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
11033082|NCT01217411|OG000|Outcome|Phase I Arm I|Arm 1: Patients with 4 or more lesions will receive Whole Brain Radiation Therapy (WBRT) combined with R04929097 (study drug) 1st cohort: Starting dose of 5mg (2nd cohort 10mg, 3rd cohort 20mg) (3 days on/4 days off continuous) 1 day prior to beginning WBRT
11033083|NCT01217411|OG001|Outcome|Phase 1 Arm II|Arm 2: Patients with less than 4 lesions will receive Stereotactic Radiosurgery (SRS) combined with R04929097 (study drug). 1st cohort: starting dose of 5mg (2nd cohort 10mg, 3rd cohort 20 mg) (3 days on/4 days off continuous) 3 days prior to SRS)
11033084|NCT01217411|EG000|Reported Event|Phase 1 Arm I (WBRT + R04929097)|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
11033085|NCT01217411|EG001|Reported Event|Phase 1 Arm II (SRS + RO4929097)|"Patients with =< 3 brain lesions receive RO4929097 and undergo SRS. For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality"
11033086|NCT01217437|BG000|Baseline|Arm I (Temozolomide, Irinotecan Hydrochloride)|"Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO"
11033087|NCT01217437|BG001|Baseline|Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)|"Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.~Bevacizumab: Given IV~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO"
11033088|NCT01217437|BG002|Baseline|Total|Total of all reporting groups
11033089|NCT01217437|FG000|Participant Flow|Arm I (Temozolomide, Irinotecan Hydrochloride)|"Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO"
11033090|NCT01217437|FG001|Participant Flow|Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)|"Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.~Bevacizumab: Given IV~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO"
11033091|NCT01217437|OG000|Outcome|Arm I (Temozolomide, Irinotecan Hydrochloride)|"Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO"
11033092|NCT01217437|OG001|Outcome|Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)|"Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.~Bevacizumab: Given IV~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO"
11033093|NCT01217437|EG000|Reported Event|Arm I (Temozolomide, Irinotecan Hydrochloride)|"Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO"
11033094|NCT01217437|EG001|Reported Event|Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)|"Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.~Bevacizumab: Given IV~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO"
11033095|NCT01217463|BG000|Baseline|Trafermin|Trafermin 0.01% spray
11033096|NCT01217463|BG001|Baseline|Placebo|Matching placebo spray
11033097|NCT01217463|BG002|Baseline|Total|Total of all reporting groups
11033098|NCT01217463|FG000|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
11033099|NCT01217463|FG001|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
11033100|NCT01217463|OG000|Outcome|Trafermin|Trafermin 0.01% spray
11033101|NCT01217463|OG001|Outcome|Placebo|Matching placebo spray
11033102|NCT01217463|OG000|Outcome|Trafermin 0.01% Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
11033103|NCT01217463|OG001|Outcome|Matching Placebo Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
11033104|NCT01217463|EG000|Reported Event|Trafermin|Trafermin 0.01% spray
11033105|NCT01217463|EG001|Reported Event|Placebo|Matching placebo spray
11033106|NCT01217476|BG000|Baseline|Trafermin|Trafermin 0.01% spray
11033107|NCT01217476|BG001|Baseline|Placebo|Matching placebo spray
11033108|NCT01217476|BG002|Baseline|Total|Total of all reporting groups
11033109|NCT01217476|FG000|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
11033110|NCT01217476|FG001|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
11033111|NCT01217476|OG000|Outcome|Trafermin|Trafermin 0.01% spray
11033112|NCT01217476|OG001|Outcome|Placebo|Matching placebo spray
11033113|NCT01217476|EG000|Reported Event|Trafermin|Trafermin 0.01% spray
11033114|NCT01217476|EG001|Reported Event|Placebo|Matching placebo spray
11033115|NCT01217515|BG000|Baseline|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
11033116|NCT01217515|BG001|Baseline|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
11033117|NCT01217515|BG002|Baseline|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
11225865|NCT02370602|BG005|Baseline|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
11033118|NCT01217515|BG003|Baseline|Total|Total of all reporting groups
11033119|NCT01217515|FG000|Participant Flow|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
11033120|NCT01217515|FG001|Participant Flow|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
11033121|NCT01217515|FG002|Participant Flow|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
11033122|NCT01217515|OG000|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
11033123|NCT01217515|OG001|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
11033124|NCT01217515|OG002|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
11033125|NCT01217515|EG000|Reported Event|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
11033126|NCT01217515|EG001|Reported Event|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
11033127|NCT01217515|EG002|Reported Event|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
11033128|NCT01217606|BG000|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
11033129|NCT01217606|BG001|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
11033130|NCT01217606|BG002|Baseline|Total|Total of all reporting groups
11033131|NCT01217606|FG000|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
11033132|NCT01217606|FG001|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
11033133|NCT01217606|OG000|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
11033134|NCT01217606|OG001|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
11225866|NCT02370602|BG006|Baseline|Total|Total of all reporting groups
11033135|NCT01217606|EG000|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
11033136|NCT01217606|EG001|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
11033137|NCT01217749|BG000|Baseline|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
11033138|NCT01217749|BG001|Baseline|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
11033139|NCT01217749|BG002|Baseline|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
11033140|NCT01217749|BG003|Baseline|Total|Total of all reporting groups
11033141|NCT01217749|FG000|Participant Flow|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
11033142|NCT01217749|FG001|Participant Flow|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
11033143|NCT01217749|FG002|Participant Flow|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
11033144|NCT01217749|OG000|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
11033145|NCT01217749|OG001|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
11033146|NCT01217749|OG002|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
11033147|NCT01217749|OG000|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
11033148|NCT01217749|OG000|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO daily was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
11033149|NCT01217749|EG000|Reported Event|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
11033150|NCT01217749|EG001|Reported Event|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
11033151|NCT01217749|EG002|Reported Event|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
11033152|NCT01217801|BG000|Baseline|Ondanestron Orally Dissolving Filmstrip|Ondanestron Orally Dissolving Filmstrip (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Disintegrating tablets (8 mg); AUCs for each period will be calculated.
11033153|NCT01217801|BG001|Baseline|Ondanestron Orally Disintegrating Tablet|Ondanestron Orally Disintegrating Tablet (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Dissolving Filmstrip (8 mg); AUCs for each period will be calculated.
11033154|NCT01217801|BG002|Baseline|Total|Total of all reporting groups
11033155|NCT01217801|FG000|Participant Flow|Ondansetron Orally Dissolving Filmstrip Then ODT|Ondansetron Orally Dissolving Filmstrip 8 mg then 7 days then Ondansetron Orally Disintegrating Tablet 8 mg measure AUC
11033156|NCT01217801|FG001|Participant Flow|Ondansetron Orally Disintegrating Tablet Then OD Film|Ondansetron Orally Disintegrating Tablet AUC Ondansetron 8 mg then 7 days then Ondansetron Orally Disintegrating Film 8 mg measure AUC
11033157|NCT01217801|OG000|Outcome|Film|AUC film strip
11033158|NCT01217801|OG001|Outcome|Tablet|tablet AUC
11033159|NCT01217801|EG000|Reported Event|Ondanestron Orally Dissolving Filmstrip|Ondanestron Orally Dissolving Filmstrip AUC
11033160|NCT01217801|EG001|Reported Event|Ondanestron Orally Disintegrating Tablet|Ondanestron Orally Disintegrating Tablet AUC
11033161|NCT01217814|BG000|Baseline|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
11033162|NCT01217814|BG001|Baseline|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
11033163|NCT01217814|BG002|Baseline|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
11033164|NCT01217814|BG003|Baseline|Total|Total of all reporting groups
11033165|NCT01217814|FG000|Participant Flow|Placebo|Subcutaneous (SC) injection of placebo 2 mL once a week (qw) to match sarilumab and 0.5 mL every 4 weeks (q4w) to match golimumab on top of methotrexate (MTX) (15-25 mg) qw for 12 weeks.
11033166|NCT01217814|FG001|Participant Flow|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
11033167|NCT01217814|FG002|Participant Flow|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
11033168|NCT01217814|OG000|Outcome|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
11033169|NCT01217814|OG001|Outcome|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
11033170|NCT01217814|OG002|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
11033171|NCT01217814|OG000|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
11033172|NCT01217814|EG000|Reported Event|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
11033173|NCT01217814|EG001|Reported Event|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
11033174|NCT01217814|EG002|Reported Event|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
11225867|NCT02370602|FG000|Participant Flow|[^11C]T-773 Only|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
11033175|NCT01217827|BG000|Baseline|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
11033176|NCT01217827|BG001|Baseline|Control|This group does not receive an intervention.
11033177|NCT01217827|BG002|Baseline|Total|Total of all reporting groups
11033178|NCT01217827|FG000|Participant Flow|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
11033179|NCT01217827|FG001|Participant Flow|Control|This group does not receive an intervention.
11033180|NCT01217827|OG000|Outcome|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
11033181|NCT01217827|OG001|Outcome|Control|This group does not receive an intervention.
11033182|NCT01217827|EG000|Reported Event|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
11033183|NCT01217827|EG001|Reported Event|Control|This group does not receive an intervention.
10887072|NCT00498602|EG004|Reported Event|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11033184|NCT01217840|BG000|Baseline|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
11033185|NCT01217840|BG001|Baseline|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
11033186|NCT01217840|BG002|Baseline|Total|Total of all reporting groups
11033187|NCT01217840|FG000|Participant Flow|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
11033188|NCT01217840|FG001|Participant Flow|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
10887073|NCT00498602|EG005|Reported Event|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11033189|NCT01217840|OG000|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
11033190|NCT01217840|OG001|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
11033191|NCT01217840|OG001|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
11033192|NCT01217840|EG000|Reported Event|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
11033193|NCT01217840|EG001|Reported Event|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
11033194|NCT01217892|BG000|Baseline|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033195|NCT01217892|BG001|Baseline|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033196|NCT01217892|BG002|Baseline|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033197|NCT01217892|BG003|Baseline|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
11033198|NCT01217892|BG004|Baseline|Total|Total of all reporting groups
11033199|NCT01217892|FG000|Participant Flow|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033200|NCT01217892|FG001|Participant Flow|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033201|NCT01217892|FG002|Participant Flow|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033202|NCT01217892|FG003|Participant Flow|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
11033203|NCT01217892|OG000|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033204|NCT01217892|OG001|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033205|NCT01217892|OG002|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033206|NCT01217892|OG003|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
11033207|NCT01217892|EG000|Reported Event|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
10887074|NCT00498602|EG006|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11033208|NCT01217892|EG001|Reported Event|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033209|NCT01217892|EG002|Reported Event|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
11033210|NCT01217892|EG003|Reported Event|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
11033211|NCT01217944|BG000|Baseline|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
11033212|NCT01217944|BG001|Baseline|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
11033213|NCT01217944|BG002|Baseline|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
11033214|NCT01217944|BG003|Baseline|Total|Total of all reporting groups
11033215|NCT01217944|FG000|Participant Flow|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
11033216|NCT01217944|FG001|Participant Flow|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
11033217|NCT01217944|FG002|Participant Flow|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
11033218|NCT01217944|OG000|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
11033219|NCT01217944|OG001|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
11033220|NCT01217944|OG002|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
11033221|NCT01217944|OG000|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
11033222|NCT01217944|EG000|Reported Event|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
11033223|NCT01217944|EG001|Reported Event|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
11033224|NCT01217944|EG002|Reported Event|Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3|After month 3 participants received active ranibizumab, active vPDT or a combination of the two if needed.
11033225|NCT01217944|EG003|Reported Event|Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3|After month 3 participants did not receive active ranibizumab
11033226|NCT01217957|BG000|Baseline|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033227|NCT01217957|BG001|Baseline|Phase 1 :Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033228|NCT01217957|BG002|Baseline|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033229|NCT01217957|BG003|Baseline|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033230|NCT01217957|BG004|Baseline|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033231|NCT01217957|BG005|Baseline|Total|Total of all reporting groups
11033232|NCT01217957|FG000|Participant Flow|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033233|NCT01217957|FG001|Participant Flow|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033234|NCT01217957|FG002|Participant Flow|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033235|NCT01217957|FG003|Participant Flow|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033236|NCT01217957|FG004|Participant Flow|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033237|NCT01217957|OG000|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033238|NCT01217957|OG001|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033239|NCT01217957|OG002|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033240|NCT01217957|OG003|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033241|NCT01217957|OG000|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033242|NCT01217957|OG001|Outcome|Phase 2: Ixazomib 4.0mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23. mg/m^2 in Phase 1.
11033243|NCT01217957|OG000|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033244|NCT01217957|OG000|Outcome|Phase 2 :Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033245|NCT01217957|OG001|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
11033246|NCT01217957|OG002|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033247|NCT01217957|OG003|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033248|NCT01217957|OG000|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033249|NCT01217957|OG001|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033250|NCT01217957|OG002|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033251|NCT01217957|OG001|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
11033252|NCT01217957|OG000|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033253|NCT01217957|OG001|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
11033254|NCT01217957|EG000|Reported Event|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033255|NCT01217957|EG001|Reported Event|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
11033256|NCT01218009|BG000|Baseline|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
11033257|NCT01218009|BG001|Baseline|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
11033258|NCT01218009|BG002|Baseline|Total|Total of all reporting groups
11033259|NCT01218009|FG000|Participant Flow|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
11033260|NCT01218009|FG001|Participant Flow|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
11033261|NCT01218009|OG000|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
11033262|NCT01218009|OG001|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
11033263|NCT01218009|EG000|Reported Event|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
11033264|NCT01218009|EG001|Reported Event|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
11033265|NCT01218048|BG000|Baseline|Neo-Adjuvant Cetuximab|"Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation + Cisplatin (or Carboplatin)~NOTE: Based the results of surgery if the treating physician feels patient is not a candidate for chemotherapy, radiation can be given alone or with cetuximab.~Cetuximab: Pre-Surgery: IV, 400 mg/m^2 day 1 then 250 mg/m^2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT~Post-surgical radiation: Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery~Cisplatin or carboplatin: Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy"
11033266|NCT01218048|FG000|Participant Flow|Neo-Adjuvant Cetuximab|"Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation + Cisplatin (or Carboplatin)~NOTE: Based the results of surgery if the treating physician feels patient is not a candidate for chemotherapy, radiation can be given alone or with cetuximab.~Cetuximab: Pre-Surgery: IV, 400 mg/m^2 day 1 then 250 mg/m^2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT~Post-surgical radiation: Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery~Cisplatin or carboplatin: Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy"
11033267|NCT01218048|OG000|Outcome|Neo-Adjuvant Cetuximab|Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m^2 alone days 8 and 15; then 250mg/m^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m^2 weekly cetuximab.
11033268|NCT01218048|OG000|Outcome|Neo-Adjuvant Cetuximab|"Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation + Cisplatin (or Carboplatin)~NOTE: Based the results of surgery if the treating physician feels patient is not a candidate for chemotherapy, radiation can be given alone or with cetuximab.~Cetuximab: Pre-Surgery: IV, 400 mg/m^2 day 1 then 250 mg/m^2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT~Post-surgical radiation: Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery~Cisplatin or carboplatin: Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy"
11033269|NCT01218048|EG000|Reported Event|Neo-Adjuvant Cetuximab|Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m^2 alone days 8 and 15; then 250mg/m^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m^2 weekly cetuximab.
11033270|NCT01218087|BG000|Baseline|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant
11033271|NCT01218087|BG001|Baseline|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
11033272|NCT01218087|BG002|Baseline|Total|Total of all reporting groups
11033273|NCT01218087|FG000|Participant Flow|Cranial Cup Device|The cranial cup device was used 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours.
11033274|NCT01218087|FG001|Participant Flow|Moldable Positioner Device|Moldable positioner device was used 24/24 hours as a comparison to the cranial cup and moldable positioner study arm.
11033275|NCT01218087|OG000|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
11033276|NCT01218087|OG001|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
11033277|NCT01218087|EG000|Reported Event|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
11033278|NCT01218087|EG001|Reported Event|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
11033279|NCT01218100|BG000|Baseline|Placebo|Placebo group - starting dose is placebo
11033280|NCT01218100|BG001|Baseline|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
11033281|NCT01218100|BG002|Baseline|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
11033282|NCT01218100|BG003|Baseline|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
11033283|NCT01218100|BG004|Baseline|Total|Total of all reporting groups
11033284|NCT01218100|FG000|Participant Flow|Placebo|Placebo group - starting dose is placebo
11033285|NCT01218100|FG001|Participant Flow|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
11033286|NCT01218100|FG002|Participant Flow|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
11033287|NCT01218100|FG003|Participant Flow|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
11033288|NCT01218100|OG000|Outcome|Placebo|Placebo group - starting dose is placebo
11033289|NCT01218100|OG001|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
11033290|NCT01218100|OG002|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
11033291|NCT01218100|OG003|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
11033292|NCT01218100|EG000|Reported Event|Placebo|Placebo group - starting dose is placebo
11033293|NCT01218100|EG001|Reported Event|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
11033294|NCT01218100|EG002|Reported Event|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
11033295|NCT01218100|EG003|Reported Event|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
10887075|NCT00498615|BG000|Baseline|3 Period Crossover Study ( All Participants)|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge.~Men and women between ages 18-80 years with a clinical diagnosis of RP secondary to SSc were eligible for the study."
11033296|NCT01218113|BG000|Baseline|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033297|NCT01218113|BG001|Baseline|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033298|NCT01218113|BG002|Baseline|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033299|NCT01218113|BG003|Baseline|Total|Total of all reporting groups
11033300|NCT01218113|FG000|Participant Flow|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033301|NCT01218113|FG001|Participant Flow|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033302|NCT01218113|FG002|Participant Flow|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033303|NCT01218113|OG000|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033304|NCT01218113|OG001|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033305|NCT01218113|OG002|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033306|NCT01218113|OG000|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
11033307|NCT01218113|OG001|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033308|NCT01218113|OG000|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033309|NCT01218113|OG001|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033310|NCT01218113|OG002|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033311|NCT01218113|OG003|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033312|NCT01218113|OG002|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
11033313|NCT01218113|EG000|Reported Event|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033314|NCT01218113|EG001|Reported Event|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033315|NCT01218113|EG002|Reported Event|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
11033316|NCT01218126|BG000|Baseline|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033317|NCT01218126|BG001|Baseline|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033318|NCT01218126|BG002|Baseline|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033319|NCT01218126|BG003|Baseline|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033320|NCT01218126|BG004|Baseline|Total|Total of all reporting groups
11033321|NCT01218126|FG000|Participant Flow|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033322|NCT01218126|FG001|Participant Flow|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 milligram (mg) tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033323|NCT01218126|FG002|Participant Flow|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033324|NCT01218126|FG003|Participant Flow|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033325|NCT01218126|OG000|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033326|NCT01218126|OG001|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033327|NCT01218126|OG002|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033328|NCT01218126|OG003|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033329|NCT01218126|EG000|Reported Event|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11225868|NCT02370602|FG001|Participant Flow|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11033330|NCT01218126|EG001|Reported Event|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033331|NCT01218126|EG002|Reported Event|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033332|NCT01218126|EG003|Reported Event|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
11033333|NCT01218204|BG000|Baseline|Part A|Four participants on 80 mg atorvastatin [either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg], received GSK1292263 800 mg for 2 weeks, and 2 participants not on lipid-modifying treatment received GSK1282263 800 mg alone for 2 weeks.
11033334|NCT01218204|BG001|Baseline|Part B|Part B included Washout phase (Participants were washed off their prior lipid-lowering therapy for 4 weeks), Run-in phase (Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period) and Treatment phase (Randomized participants after washout received monotherpy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) for 2 weeks. Participants in the 10mg atorvastatin run-in group received GSK1292263, 300 mg QD GSK1292263, 800 mg QD GSK1292263, placebo for GSK1292263 or 10 mg open-label ezetimibe for 2 weeks. Participants in the 80 mg atorvastatin run-in group received 800 mg QD GSK1292263 and placebo for GSK1292263 for 2 weeks)
11033335|NCT01218204|BG002|Baseline|Total|Total of all reporting groups
11033336|NCT01218204|FG000|Participant Flow|Part A|Four participants on 80 milligrams (mg) atorvastatin [either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40mg], received GSK1292263 800 mg for 2 weeks, and 2 participants not on lipid-modifying treatment received GSK1282263 800 mg alone for 2 weeks.
11033337|NCT01218204|FG001|Participant Flow|Part B Washout|Participants were washed off their prior lipid-lowering therapy for 4 weeks.
11033338|NCT01218204|FG002|Participant Flow|Part B Run-in|Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period.
11033339|NCT01218204|FG003|Participant Flow|Part B Pooled Treatment Arm|In this pooled arm, after washout, randomized participants were stratified into 11 arms to receive either atorvastatin 10 mg along with 100 mg or 300 mg or 800 mg of GSK129226 or placebo or ezetimibe 10 mg once daily for 2 weeks; or atorvastatin 80 mg along with 800 mg of GSK129226 or placebo once daily for 2 weeks; or monotherapy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) once daily for 2 weeks.
11033340|NCT01218204|OG000|Outcome|80 mg Atorvastatin + 800 mg GSK1292263|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
11033341|NCT01218204|OG001|Outcome|800 mg GSK1292263|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
11033342|NCT01218204|OG000|Outcome|Pre-treatment|This was the time period prior to Day 1 of Washout Phase.
11033343|NCT01218204|OG001|Outcome|Washout|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
11033344|NCT01218204|OG000|Outcome|Atorvastatin 10 mg|After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.
11033345|NCT01218204|OG001|Outcome|Atorvastatin 80 mg|After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.
11033346|NCT01218204|OG000|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
11033347|NCT01218204|OG001|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
11033348|NCT01218204|OG002|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
11033349|NCT01218204|OG003|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
11033350|NCT01218204|OG004|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
11033351|NCT01218204|OG005|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
11033352|NCT01218204|OG006|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
11033353|NCT01218204|OG007|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks
11033354|NCT01218204|OG008|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks
11033355|NCT01218204|OG009|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks
11033356|NCT01218204|OG010|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
11033357|NCT01218204|OG000|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
11033358|NCT01218204|OG001|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
11033359|NCT01218204|OG000|Outcome|Washout|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
11033360|NCT01218204|OG007|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
11033361|NCT01218204|OG008|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
11033362|NCT01218204|OG009|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
11033363|NCT01218204|OG010|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
11033364|NCT01218204|OG003|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
11033365|NCT01218204|OG004|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
11033366|NCT01218204|OG005|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
11033367|NCT01218204|OG006|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
11033368|NCT01218204|EG000|Reported Event|80 mg Atorvastatin + 800 mg GSK1292263 (Part A)|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
11033369|NCT01218204|EG001|Reported Event|800 mg GSK1292263 (Part A)|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
11033370|NCT01218204|EG002|Reported Event|Pre-treatment (Part B)|This was the time period prior to Day 1 of Washout Phase.
11033371|NCT01218204|EG003|Reported Event|Washout (Part B)|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
11033372|NCT01218204|EG004|Reported Event|Atorvastatin 10 mg (Part B Run-in)|After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.
11033373|NCT01218204|EG005|Reported Event|Atorvastatin 80 mg (Part B Run-in)|After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.
11033374|NCT01218204|EG006|Reported Event|Atorvastatin 10 mg + GSK1292263 100 mg (Part B Treatment)|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
11033375|NCT01218204|EG007|Reported Event|Atorvastatin 10 mg + GSK1292263 300 mg (Part B Treatment)|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
11033376|NCT01218204|EG008|Reported Event|Atorvastatin 10 mg + GSK1292263 800 mg (Part B Treatment)|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
11033377|NCT01218204|EG009|Reported Event|Atorvastatin 10 mg + Placebo (Part B Treatment)|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
10849771|NCT00298155|FG002|Participant Flow|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
11033378|NCT01218204|EG010|Reported Event|Atorvastatin 10 mg + Ezetimibe 10 mg (Part B Treatment)|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
11033379|NCT01218204|EG011|Reported Event|Atorvastatin 80 mg + GSK1292263 800 mg (Part B Treatment)|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
11033380|NCT01218204|EG012|Reported Event|Atorvastatin 80 mg + Placebo (Part B Treatment)|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
11033381|NCT01218204|EG013|Reported Event|GSK1292263 100 mg (Part B Treatment)|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
11033382|NCT01218204|EG014|Reported Event|GSK1292263 300 mg (Part B Treatment)|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
11033383|NCT01218204|EG015|Reported Event|GSK1292263 800 mg (Part B Treatment)|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
11033384|NCT01218204|EG016|Reported Event|Placebo (Part B Treatment)|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
11033385|NCT01218243|BG000|Baseline|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
11033386|NCT01218243|BG001|Baseline|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
11033387|NCT01218243|BG002|Baseline|Total|Total of all reporting groups
11033388|NCT01218243|FG000|Participant Flow|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
11033389|NCT01218243|FG001|Participant Flow|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
11033390|NCT01218243|OG000|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
11033391|NCT01218243|OG001|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
11033392|NCT01218243|EG000|Reported Event|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
11033393|NCT01218243|EG001|Reported Event|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
11033394|NCT01218308|BG000|Baseline|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11033395|NCT01218308|BG001|Baseline|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11033396|NCT01218308|BG002|Baseline|Total|Total of all reporting groups
11033397|NCT01218308|FG000|Participant Flow|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11033398|NCT01218308|FG001|Participant Flow|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11033399|NCT01218308|OG000|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11033400|NCT01218308|OG001|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11033401|NCT01218308|EG000|Reported Event|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11033402|NCT01218308|EG001|Reported Event|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
11033403|NCT01218399|BG000|Baseline|Symbicort|"combination of budesonide and formoterol~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
11033404|NCT01218399|BG001|Baseline|Budesonide|"control of budesonide alone~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
11033405|NCT01218399|BG002|Baseline|Total|Total of all reporting groups
11033406|NCT01218399|FG000|Participant Flow|Symbicort|"Combination of budesonide and formoterol~Symbicort will be given as per product insert (2 puffs twice daily of 160/4.5 Budesonide/formoterol)"
11033407|NCT01218399|FG001|Participant Flow|Budesonide|"Control of budesonide alone~Pulmicort Flexhaler will be given as per product insert (2 puffs twice daily of 160 mcg)"
11033408|NCT01218399|OG000|Outcome|Symbicort|"combination of budesonide and formoterol~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
11033409|NCT01218399|OG001|Outcome|Budesonide|"control of budesonide alone~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
11033410|NCT01218399|EG000|Reported Event|Symbicort|"combination of budesonide and formoterol~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
11033411|NCT01218399|EG001|Reported Event|Budesonide|"control of budesonide alone~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
11033412|NCT01218438|BG000|Baseline|Study Epochs 1-4|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study. - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
11033413|NCT01218438|FG000|Participant Flow|Study Participants|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study. - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
11033414|NCT01218438|OG000|Outcome|Study Participants|
11033415|NCT01218438|OG000|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
11033416|NCT01218438|OG001|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
11033417|NCT01218438|OG000|Outcome|Intravenous 10% - Epoch 1|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
11033418|NCT01218438|OG001|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
11033419|NCT01218438|OG000|Outcome|Study Epochs 1-4|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
11225869|NCT02370602|FG002|Participant Flow|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11033420|NCT01218438|OG000|Outcome|IV 10% 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
11033421|NCT01218438|OG001|Outcome|IV 10% 4 Weeks|
11033422|NCT01218438|OG002|Outcome|SC 20% 145% IV 1 Week|
11033423|NCT01218438|OG003|Outcome|SC 20% Adjusted 1 Week|
11033424|NCT01218438|OG004|Outcome|SC 20% Individualized 1 Week|
11033425|NCT01218438|OG000|Outcome|Overall Study Arm|
11033426|NCT01218438|OG000|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
11033427|NCT01218438|OG001|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
11033428|NCT01218438|OG002|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
11033429|NCT01218438|OG003|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously (IGSC)
11033430|NCT01218438|OG003|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
11033431|NCT01218438|OG001|Outcome|Study Epoch 1: IGIV 10% Every 4 Week|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
11033432|NCT01218438|OG000|Outcome|Study Epoch 1: IGIV 10% Every 3 WeeksOverall Study Arm|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
11033433|NCT01218438|OG002|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
11033434|NCT01218438|OG003|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
11033435|NCT01218438|OG000|Outcome|Correction Factor|
11033436|NCT01218438|OG000|Outcome|INTRAVENOUS 10%|
11033437|NCT01218438|OG001|Outcome|SUBCUTANEOUS 20%|
11033438|NCT01218438|OG000|Outcome|IGIV, 10%|
11033439|NCT01218438|OG001|Outcome|Subcutaneous, 20%|
11033440|NCT01218438|OG000|Outcome|Intravenous 10%|
11033441|NCT01218438|OG001|Outcome|Subcutaneous 20%|
11033442|NCT01218438|OG000|Outcome|Pre-Infusion Toxicity Grade 0|Normal Systolic Blood Pressure
11033443|NCT01218438|OG001|Outcome|Pre-Infusion Toxicity Grade 1|Systolic Blood Pressure 141-150 mmHg
11033444|NCT01218438|OG002|Outcome|Pre-Infusion Toxicity Grade 2|Systolic Blood Pressure 151-155 mmHg
11033445|NCT01218438|OG003|Outcome|Pre-Infusion Toxicity Grade 3|Systolic Blood Pressure >155 mmHg
11033446|NCT01218438|OG004|Outcome|Pre-Infusion Toxicity Grade 4|ER visit or hospitalization for malignant hypertension
11033447|NCT01218438|OG000|Outcome|Pre-Infusion Toxicity Grade 0|Normal Diastolic Blood Pressure
11033448|NCT01218438|OG001|Outcome|Pre-Infusion Toxicity Grade 1|Diastolic Blood Pressure 141-150 mmHg
11033449|NCT01218438|OG002|Outcome|Pre-Infusion Toxicity Grade 2|Diastolic Blood Pressure 151-155 mmHg
11033450|NCT01218438|OG003|Outcome|Pre-Infusion Toxicity Grade 3|Diastolic Blood Pressure >155 mmHg
11033451|NCT01218438|OG000|Outcome|Pre-Infusion Toxicity Grade 0|Normal Heart Rate (Pulse)
11033452|NCT01218438|OG001|Outcome|Pre-Infusion Toxicity Grade 1|Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute)
11033453|NCT01218438|OG002|Outcome|Pre-Infusion Toxicity Grade 2|Heart Rate (Pulse): Either Bradycardia (45 - 49 beats per minute) OR Tachycardia (116 - 130 beats per minute)
11033454|NCT01218438|OG003|Outcome|Pre-Infusion Toxicity Grade 3|Heart Rate (Pulse): Either Bradycardia (< 45 beats per minute) OR Tachycardia (> 130 beats per minute)
11033455|NCT01218438|OG004|Outcome|Pre-Infusion Toxicity Grade 4|Heart Rate (Pulse): Either Bradycardia (ER visit or hospitalization for arrhythmia) OR Tachycardia (ER visit or hospitalization for arrhythmia)
11033456|NCT01218438|OG000|Outcome|Pre-Infusion Toxicity Grade 0|Normal Respiratory Rate
11033457|NCT01218438|OG001|Outcome|Pre-Infusion Toxicity Grade 1|Respiratory Rate: 17 - 20 breaths per minute
11033458|NCT01218438|OG002|Outcome|Pre-Infusion Toxicity Grade 2|Respiratory Rate: 21 - 25 breaths per minute
11033459|NCT01218438|OG003|Outcome|Pre-Infusion Toxicity Grade 3|Respiratory Rate: > 25 breaths per minute
11033460|NCT01218438|OG004|Outcome|Pre-Infusion Toxicity Grade 4|Intubation
11033461|NCT01218438|OG000|Outcome|Pre-Infusion Toxicity Grade 0|Normal Body temperature
11033462|NCT01218438|OG001|Outcome|Pre-Infusion Toxicity Grade 1|Body Temperature, Fever (°C) of: 38.0 - 38.4
11033463|NCT01218438|OG002|Outcome|Pre-Infusion Toxicity Grade 2|Body Temperature, Fever (°C) of: 38.5 - 38.9
11033464|NCT01218438|OG003|Outcome|Pre-Infusion Toxicity Grade 3|Body Temperature, Fever (°C) of: 39.0 - 40
11033465|NCT01218438|OG004|Outcome|Pre-Infusion Toxicity Grade 4|Body Temperature, Fever (°C) of: > 40
11033466|NCT01218438|OG000|Outcome|Start of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
11033467|NCT01218438|OG001|Outcome|End of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
11033468|NCT01218438|OG002|Outcome|End of Study Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
11033469|NCT01218438|OG003|Outcome|End of Study Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
11033470|NCT01218438|OG004|Outcome|Change End Epoch 1 to End Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
11033471|NCT01218438|OG005|Outcome|Change End Epoch 1 to End Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
11033472|NCT01218438|OG000|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
11033473|NCT01218438|OG001|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
11033474|NCT01218438|OG002|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
11033475|NCT01218438|OG003|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
11033476|NCT01218438|OG004|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
11033477|NCT01218438|OG005|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
11033478|NCT01218438|OG000|Outcome|START OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
11033479|NCT01218438|OG001|Outcome|END OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
11033480|NCT01218438|OG002|Outcome|END OF STUDY EPOCH 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
11033481|NCT01218438|OG003|Outcome|END OF STUDY EPOCH 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
11033482|NCT01218438|OG004|Outcome|CHANGE END EPOCH 1 TO END EPOCH 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
11033483|NCT01218438|OG005|Outcome|CHANGE END EPOCH 1 TO END EPOCH 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
11033484|NCT01218438|EG000|Reported Event|Study Epoch 1: Intravenous 10% Treatment|
11033485|NCT01218438|EG001|Reported Event|Study Epochs 2-4: Subcutaneous 20% Treatment|
11033486|NCT01218477|BG000|Baseline|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
11033487|NCT01218477|BG001|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), plus BMS-833923, 50 mg, QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033488|NCT01218477|BG002|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033489|NCT01218477|BG003|Baseline|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033490|NCT01218477|BG004|Baseline|Total|Total of all reporting groups
11033491|NCT01218477|FG000|Participant Flow|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
11033492|NCT01218477|FG001|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg QD
11033493|NCT01218477|FG002|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033494|NCT01218477|FG003|Participant Flow|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033495|NCT01218477|OG000|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
11033496|NCT01218477|OG000|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
11033497|NCT01218477|OG001|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
11033498|NCT01218477|OG002|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033499|NCT01218477|OG003|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033500|NCT01218477|OG000|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
11033501|NCT01218477|OG001|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
11033502|NCT01218477|OG002|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days, followed by dasatinib, 100/140 mg once daily (QD)
11033503|NCT01218477|EG000|Reported Event|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD) (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033504|NCT01218477|EG001|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatanib, 100/140 mg once daily (QD), as oral tablets plus BMS-833923, 50 mg, QD (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033505|NCT01218477|EG002|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatanib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033506|NCT01218477|EG003|Reported Event|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
11033507|NCT01218516|BG000|Baseline|Combination Therapy: Placebo + Chemotherapy|During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
11033508|NCT01218516|BG001|Baseline|Combination Therapy: Farletuzumab + Chemotherapy|During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
11033509|NCT01218516|BG002|Baseline|Total|Total of all reporting groups
11033510|NCT01218516|FG000|Participant Flow|Combination Therapy: Placebo + Chemotherapy|During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
11033511|NCT01218516|FG001|Participant Flow|Combination Therapy: Farletuzumab + Chemotherapy|During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
11033512|NCT01218516|FG002|Participant Flow|Monotherapy: Placebo|Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
11033513|NCT01218516|FG003|Participant Flow|Monotherapy: Farletuzumab|Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
11033514|NCT01218516|OG000|Outcome|Combination Therapy: Placebo + Chemotherapy|During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
11033515|NCT01218516|OG001|Outcome|Combination Therapy: Farletuzumab + Chemotherapy|During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
11033516|NCT01218516|OG002|Outcome|Monotherapy: Placebo|Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
11033517|NCT01218516|OG003|Outcome|Monotherapy: Farletuzumab|Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
11033518|NCT01218516|EG000|Reported Event|Combination Therapy: Placebo + Chemotherapy|During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
11033519|NCT01218516|EG001|Reported Event|Combination Therapy: Farletuzumab + Chemotherapy|During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
11033520|NCT01218516|EG002|Reported Event|Monotherapy: Placebo|Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
11033521|NCT01218516|EG003|Reported Event|Monotherapy: Farletuzumab|Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
11033522|NCT01218542|BG000|Baseline|Volumetric Modulated Arc Therapy|"Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.~Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy."
11033523|NCT01218542|FG000|Participant Flow|Volumetric Modulated Arc Therapy|"Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.~Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy."
11033524|NCT01218542|OG000|Outcome|Volumetric Modulated Arc Therapy|"Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.~Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy."
11033525|NCT01218542|OG000|Outcome|Volumetric Modulated Arc Therapy|The 2-year neurocognitive effect was not collected. We collected and reported neurocognitive data up to 6 months after treatment.
11033526|NCT01218542|EG000|Reported Event|Volumetric Modulated Arc Therapy|"Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.~Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy."
11033527|NCT01218594|BG000|Baseline|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
11033528|NCT01218594|FG000|Participant Flow|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
11033529|NCT01218594|OG000|Outcome|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
11033530|NCT01218594|EG000|Reported Event|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
11033531|NCT01218646|BG000|Baseline|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
11033532|NCT01218646|BG001|Baseline|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
11033533|NCT01218646|BG002|Baseline|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
11033534|NCT01218646|BG003|Baseline|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
11033535|NCT01218646|BG004|Baseline|Total|Total of all reporting groups
11033536|NCT01218646|FG000|Participant Flow|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
11033537|NCT01218646|FG001|Participant Flow|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
11033538|NCT01218646|FG002|Participant Flow|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
11033539|NCT01218646|FG003|Participant Flow|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine.
11033540|NCT01218646|OG000|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
11033541|NCT01218646|OG001|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
11033542|NCT01218646|OG002|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
11033543|NCT01218646|OG003|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
11033544|NCT01218646|EG000|Reported Event|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
11033545|NCT01218646|EG001|Reported Event|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
11033546|NCT01218646|EG002|Reported Event|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
11033547|NCT01218646|EG003|Reported Event|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
11033548|NCT01218659|BG000|Baseline|Migalastat (0-18 Months)|Participants received 150 mg migalastat orally QOD during the 18-month randomized treatment period. Participants received an inactive reminder capsule on alternate days during both treatment periods.
11033549|NCT01218659|BG001|Baseline|ERT (0-18 Months)|Participants received ERT (either agalsidase alfa or agalsidase beta) as prescribed by the participant's treating physician and administered in accordance with the approved prescribing information during the 18-month randomized treatment period. Participants were required to be given >80% of the currently labeled dose and regimen during the 18-month randomized treatment period. Participants received an inactive reminder capsule on alternate days during the OLE.
11033550|NCT01218659|BG002|Baseline|Total|Total of all reporting groups
11033551|NCT01218659|FG000|Participant Flow|Migalastat (0-18 Months)|Participants received 150 milligrams (mg) of migalastat hydrochloride (migalastat) (equivalent to 123 mg of migalastat) orally once every other day (QOD) during the 18-month randomized treatment period (0-18 months). Participants received an inactive reminder capsule on alternate days during both treatment periods.
11033552|NCT01218659|FG001|Participant Flow|ERT (0-18 Months)|Participants received ERT (either agalsidase alfa or agalsidase beta) as prescribed by the participant's treating physician and administered in accordance with the approved prescribing information during the 18-month randomized treatment period (0-18 months). Participants were required to be given >80% of the currently labeled dose and regimen during the 18-month randomized treatment period.
11033553|NCT01218659|FG002|Participant Flow|All Migalastat (0-30 Months)|Participants in this group are composed of participants from the Migalastat (0-18 months) and the ERT (0-18 months) groups. Therefore, participants in the All Migalastat group received at least 1 dose of 150 mg migalastat orally QOD during the 18-month randomization period or the optional 12-month OLE (for a total time period of up to 30 months), regardless of whether or not the participant discontinued the study early, and regardless of whether they were previously randomized to migalastat or ERT during the 18-month Randomized Period (0-18 months).
11033554|NCT01218659|OG000|Outcome|Migalastat (0-18 Months)|Participants received 150 mg migalastat orally QOD during the 18-month randomized treatment period. Participants received an inactive reminder capsule on alternate days during both treatment periods.
11033555|NCT01218659|OG001|Outcome|ERT (0-18 Months)|Participants received ERT (either agalsidase alfa or agalsidase beta) as prescribed by the participant's treating physician and administered in accordance with the approved prescribing information during the 18-month randomized treatment period. Participants were required to be given >80% of the currently labeled dose and regimen during the 18-month randomized treatment period. During the optional 12-month OLE period, participants received 150 mg migalastat orally QOD. Participants received an inactive reminder capsule on alternate days during the OLE.
11033556|NCT01218659|EG000|Reported Event|Migalastat (0-18 Months)|Participants received 150 mg of migalastat orally QOD during the 18-month randomized treatment period (0-18 months). Participants received an inactive reminder capsule on alternate days during both treatment periods.
11033557|NCT01218659|EG001|Reported Event|ERT (0-18 Months)|Participants received ERT (either agalsidase alfa or agalsidase beta) as prescribed by the participant's treating physician and administered in accordance with the approved prescribing information during the 18-month randomized treatment period (0-18 months). Participants were required to be given >80% of the currently labeled dose and regimen during the 18-month randomized treatment period.
11033558|NCT01218659|EG002|Reported Event|All Migalastat (0-30 Months)|Participants in this group are composed of participants from the Migalastat (0-18 month) and the ERT (0-18 month) groups. Therefore, participants in the All Migalastat group received at least 1 dose of 150 mg migalastat orally QOD during the 18-month randomized treatment period or the optional 12-month OLE (for a total time period of up to 30 months), regardless of whether or not the participant discontinued the study early, and regardless of whether they were previously randomized to migalastat or ERT during the 18-month randomized phase (0-18 months).
11033559|NCT01218672|BG000|Baseline|GreenLight XPS|"Photoselective vaporization of the prostate using GreenLight XPS laser system.~GreenLight XPS vs. TURP: GreenLight XPS laser console GreenLight XPS consists of a 532 nm laser console capable of achieving power outputs between 20W and 180W. Laser technology is used to vaporize tissue for debulking prostatic hyperplasia and improvement of lower urinary tract symptoms. The 532 nm wavelength is in the visible spectrum as green light and is strongly absorbed by oxyhemoglobin."
11033560|NCT01218672|BG001|Baseline|TURP|"Monopolar and bipolar Transuretheral resection of the prostate (TURP)~The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system that carry the CE mark may be used for the study."
11033561|NCT01218672|BG002|Baseline|Total|Total of all reporting groups
11033562|NCT01218672|FG000|Participant Flow|GreenLight XPS|Photoselective vaporization of the prostate using GreenLight XPS Laser System.
11033563|NCT01218672|FG001|Participant Flow|TURP|Monopolar and bipolar loop TURP Systems
11033564|NCT01218672|OG000|Outcome|GreenLight XPS|Photoselective vaporization of the prostate using GreenLight XPS Laser System.
11033565|NCT01218672|OG001|Outcome|TURP|Monopolar and bipolar loop TURP Systems
11033566|NCT01218672|OG000|Outcome|GreenLight XPS|"Photoselective vaporization of the prostate using GreenLight XPS laser system.~Photoselective Vaporization of the Prostate: GreenLight XPS laser console GreenLight XPS consists of a 532 nm laser console capable of achieving power outputs between 20W and 180W. Laser technology is used to vaporize tissue for debulking prostatic hyperplasia and improvement of lower urinary tract symptoms. The 532 nm wavelength is in the visible spectrum as green light and is strongly absorbed by oxyhemoglobin.~GreenLight XPS will be used in conjunction with the MoXy™ fiber. The fiber features a side firing mechanism delivering up to180W of 532 nm light to vaporize and coagulate the prostate tissue. The fiber is guided to the treatment site by the continuous flow cystoscope, consisting of an inner and outer sheath set, 30ْ forward oblique telescope and visual obturator."
11033567|NCT01218672|OG001|Outcome|Transurethral Resection of the Prostate|"Monopolar and bipolar Transuretheral resection of the prostate (TURP)~Transurethral Resection of the Prostate: Monopolar and bipolar loop TURP Systems The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system that carry the CE mark may be used for the study."
11033568|NCT01218672|EG000|Reported Event|GreenLight XPS|Photoselective vaporization of the prostate using GreenLight XPS Laser System.
11033569|NCT01218672|EG001|Reported Event|TURP|Monopolar and bipolar Transuretheral resection of the prostate (TURP)
11033570|NCT01218802|BG000|Baseline|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
11033571|NCT01218802|BG001|Baseline|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
11033572|NCT01218802|BG002|Baseline|Total|Total of all reporting groups
11033573|NCT01218802|FG000|Participant Flow|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
11033574|NCT01218802|FG001|Participant Flow|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
11033575|NCT01218802|OG000|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
11033576|NCT01218802|OG001|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
11033577|NCT01218802|EG000|Reported Event|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
11033578|NCT01218802|EG001|Reported Event|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
11033579|NCT01218867|BG000|Baseline|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033580|NCT01218867|BG001|Baseline|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033581|NCT01218867|BG002|Baseline|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
10849772|NCT00298155|OG000|Outcome|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
11033582|NCT01218867|BG003|Baseline|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033583|NCT01218867|BG004|Baseline|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033584|NCT01218867|BG005|Baseline|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033585|NCT01218867|BG006|Baseline|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033586|NCT01218867|BG007|Baseline|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033587|NCT01218867|BG008|Baseline|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033588|NCT01218867|BG009|Baseline|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11066443|NCT01392378|EG002|Reported Event|13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
11033589|NCT01218867|BG010|Baseline|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033590|NCT01218867|BG011|Baseline|Total|Total of all reporting groups
11033591|NCT01218867|FG000|Participant Flow|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033592|NCT01218867|FG001|Participant Flow|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033593|NCT01218867|FG002|Participant Flow|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033594|NCT01218867|FG003|Participant Flow|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033595|NCT01218867|FG004|Participant Flow|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033596|NCT01218867|FG005|Participant Flow|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11066444|NCT01392378|EG003|Reported Event|13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
11033597|NCT01218867|FG006|Participant Flow|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033598|NCT01218867|FG007|Participant Flow|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033599|NCT01218867|FG008|Participant Flow|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033600|NCT01218867|FG009|Participant Flow|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033601|NCT01218867|FG010|Participant Flow|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033602|NCT01218867|OG000|Outcome|Cohort 1 - 1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11066445|NCT01392378|EG004|Reported Event|13vPnC + INFANRIX Hexa - Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).
10849773|NCT00298155|OG001|Outcome|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
11033603|NCT01218867|OG001|Outcome|Cohort 2 - 3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033604|NCT01218867|OG002|Outcome|Cohort 3 - 1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033605|NCT01218867|OG003|Outcome|Cohort 4 - 3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033606|NCT01218867|OG004|Outcome|Cohort 5 - 1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033607|NCT01218867|OG005|Outcome|Cohort 6 - 3x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033608|NCT01218867|OG006|Outcome|Cohort 7 - 1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033609|NCT01218867|OG007|Outcome|Cohort 8 - 1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033610|NCT01218867|OG008|Outcome|Cohort 9 - 3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033611|NCT01218867|OG009|Outcome|Cohort 10 - 1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033612|NCT01218867|OG010|Outcome|Cohort 11 - 3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033613|NCT01218867|OG000|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033614|NCT01218867|OG001|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033615|NCT01218867|OG002|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033616|NCT01218867|OG003|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033617|NCT01218867|OG004|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11066446|NCT01392378|EG005|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
11033618|NCT01218867|OG005|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033619|NCT01218867|OG006|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033620|NCT01218867|OG007|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033621|NCT01218867|OG008|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033622|NCT01218867|OG009|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033623|NCT01218867|OG010|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033624|NCT01218867|EG000|Reported Event|Cohort 1 (1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
10887076|NCT00498615|FG000|Participant Flow|Sequence 1|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods.
11033625|NCT01218867|EG001|Reported Event|Cohort 2 (3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033626|NCT01218867|EG002|Reported Event|Cohort 3 (1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033627|NCT01218867|EG003|Reported Event|Cohort 4 (3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033628|NCT01218867|EG004|Reported Event|Cohort 5 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033629|NCT01218867|EG005|Reported Event|Cohort 6 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033630|NCT01218867|EG006|Reported Event|Cohort 7 (1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033631|NCT01218867|EG007|Reported Event|Cohort 8 (1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11066447|NCT01392378|EG006|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
11033632|NCT01218867|EG008|Reported Event|Cohort 9 (3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033633|NCT01218867|EG009|Reported Event|Cohort 10 (1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033634|NCT01218867|EG010|Reported Event|Cohort 11 (3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
11033635|NCT01218958|BG000|Baseline|Medisorb Naltrexone 190 mg|
11033636|NCT01218958|BG001|Baseline|Medisorb Naltrexone 380 mg|
11033637|NCT01218958|BG002|Baseline|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
11033638|NCT01218958|BG003|Baseline|Total|Total of all reporting groups
11033639|NCT01218958|FG000|Participant Flow|Medisorb Naltrexone 190 mg|
11033640|NCT01218958|FG001|Participant Flow|Medisorb Naltrexone 380 mg|
11033641|NCT01218958|FG002|Participant Flow|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
11033642|NCT01218958|OG000|Outcome|Medisorb Naltrexone 190 mg|
10887077|NCT00498615|FG001|Participant Flow|Sequence 2|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
11033643|NCT01218958|OG001|Outcome|Medisorb Naltrexone 380 mg|
11033644|NCT01218958|OG002|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
11033645|NCT01218958|EG000|Reported Event|Medisorb Naltrexone 190 mg|
11033646|NCT01218958|EG001|Reported Event|Medisorb Naltrexone 380 mg|
11033647|NCT01218958|EG002|Reported Event|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
11033648|NCT01218971|BG000|Baseline|Medisorb Naltrexone 380 mg|
11033649|NCT01218971|BG001|Baseline|Medisorb Naltrexone 190 mg|
11033650|NCT01218971|BG002|Baseline|Total|Total of all reporting groups
11033651|NCT01218971|FG000|Participant Flow|Medisorb Naltrexone 380 mg|
11033652|NCT01218971|FG001|Participant Flow|Medisorb Naltrexone 190 mg|
11033653|NCT01218971|OG000|Outcome|Medisorb Naltrexone 380 mg|
11033654|NCT01218971|OG001|Outcome|Medisorb Naltrexone 190 mg|
11033655|NCT01218971|EG000|Reported Event|Medisorb Naltrexone 380mg--Combined|Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
11033656|NCT01218971|EG001|Reported Event|Medisorb Naltrexone 190mg--Combined|Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
11033657|NCT01218971|EG002|Reported Event|Placebo to 380mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
11033658|NCT01218971|EG003|Reported Event|380mg to 380mg|Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
11033659|NCT01218971|EG004|Reported Event|Placebo to 190mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
11033660|NCT01218971|EG005|Reported Event|190mg to 190mg|includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
11033661|NCT01218984|BG000|Baseline|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
11033662|NCT01218984|BG001|Baseline|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
11033663|NCT01218984|BG002|Baseline|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
11033664|NCT01218984|BG003|Baseline|Total|Total of all reporting groups
11033665|NCT01218984|FG000|Participant Flow|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
11033666|NCT01218984|FG001|Participant Flow|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
11033667|NCT01218984|FG002|Participant Flow|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
11033668|NCT01218984|OG000|Outcome|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
11033669|NCT01218984|OG001|Outcome|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
11033670|NCT01218984|OG002|Outcome|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
11033671|NCT01218984|EG000|Reported Event|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
11033672|NCT01218984|EG001|Reported Event|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
11033673|NCT01218984|EG002|Reported Event|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
11033674|NCT01218997|BG000|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
11033675|NCT01218997|BG001|Baseline|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
11033676|NCT01218997|BG002|Baseline|Total|Total of all reporting groups
11033677|NCT01218997|FG000|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
11033678|NCT01218997|FG001|Participant Flow|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
11033679|NCT01218997|OG000|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
11033680|NCT01218997|OG001|Outcome|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
11033681|NCT01218997|EG000|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
11033682|NCT01218997|EG001|Reported Event|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
11033683|NCT01219738|BG000|Baseline|Asthma|"asthmatic subject received different doses of inhaled budesonide~Budesonide: A single inhaled dose of 360ug budesonide from a DPI.~Budesonide: A single inhaled dose of 720ug budesonide from a DPI.~Budesonide: A single dose of 1440ug of the budesonide from DPI.~Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.~Placebo: A single inhaled dose of placebo from a DPI."
11033684|NCT01219738|FG000|Participant Flow|All Study Participants|"asthmatic subject received different doses of inhaled budesonide~Budesonide: A single inhaled dose of 360ug budesonide from a DPI.~Budesonide: A single inhaled dose of 720ug budesonide from a DPI.~Budesonide: A single dose of 1440ug of the budesonide from DPI.~Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.~Placebo: A single inhaled dose of placebo from a DPI."
11033685|NCT01219738|OG000|Outcome|Budesonide 360ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
11033686|NCT01219738|OG001|Outcome|Budesonide 720ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
11033687|NCT01219738|OG002|Outcome|Budesonide 1440ug|Budesonide: A single dose of 1440ug of the budesonide from DPI.
11033688|NCT01219738|OG003|Outcome|Budesonide 720ug 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
11033689|NCT01219738|OG004|Outcome|Placebo|Placebo: A single inhaled dose of placebo from a DPI
11033690|NCT01219738|OG000|Outcome|Budesonide 360 ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
11033691|NCT01219738|OG001|Outcome|Budesonide 720 ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
11033692|NCT01219738|OG002|Outcome|Budesonide 1440 ug|Budesonide: A single inhaled dose of 1440ug budesonide from a DPI.
11033693|NCT01219738|OG003|Outcome|720ug of Budesonide 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
11033694|NCT01219738|OG004|Outcome|Placebo|A single inhaled dose of placebo from a DPI
11033695|NCT01219738|EG000|Reported Event|All Study Participants|Budesonide:was given in different doses
11033696|NCT01219777|BG000|Baseline|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
11033697|NCT01219777|FG000|Participant Flow|Carboplatin + Weekly Paclitaxel and Bevacizumab|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.~Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
11066448|NCT01392378|EG007|Reported Event|13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
11033698|NCT01219777|OG000|Outcome|Arm I|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.~Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
11033699|NCT01219777|OG000|Outcome|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
11033700|NCT01219777|EG000|Reported Event|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
11033701|NCT01219855|BG000|Baseline|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
11033702|NCT01219855|BG001|Baseline|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
11033703|NCT01219855|BG002|Baseline|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
11033704|NCT01219855|BG003|Baseline|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
11033705|NCT01219855|BG004|Baseline|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
11033706|NCT01219855|BG005|Baseline|Total|Total of all reporting groups
11033707|NCT01219855|FG000|Participant Flow|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
11033708|NCT01219855|FG001|Participant Flow|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
11033709|NCT01219855|FG002|Participant Flow|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
11033710|NCT01219855|FG003|Participant Flow|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
11033711|NCT01219855|FG004|Participant Flow|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
10887078|NCT00498615|FG002|Participant Flow|Sequence 3|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
11033712|NCT01219855|OG000|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
11033713|NCT01219855|OG001|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
11033714|NCT01219855|OG002|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
11033715|NCT01219855|OG003|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
11033716|NCT01219855|OG004|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
11033717|NCT01219855|EG000|Reported Event|Cohorts 1,2: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
11033718|NCT01219855|EG001|Reported Event|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
11033719|NCT01219855|EG002|Reported Event|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
11033720|NCT01219855|EG003|Reported Event|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
11033721|NCT01219881|BG000|Baseline|Desflurane|Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane (5.4 to 7.4%)
11033722|NCT01219881|BG001|Baseline|Sevoflurane|Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane (1.4 to 2.5%).
11033723|NCT01219881|BG002|Baseline|Total|Total of all reporting groups
11033724|NCT01219881|FG000|Participant Flow|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Desflurane : 5.4 to 7.4% desflurane"
11033725|NCT01219881|FG001|Participant Flow|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
11033726|NCT01219881|OG000|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
11033727|NCT01219881|OG001|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
11033728|NCT01219881|EG000|Reported Event|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
11033729|NCT01219881|EG001|Reported Event|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
11033730|NCT01219933|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
11033731|NCT01219933|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) once every 4 weeks and methotrexate (MTX) 7.5 to 25 mg per week (mg/week; per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received an oral glucocorticoid (GC; no product/dose limitation) until low disease activity (LDA; defined as Disease Activity Score Based on 28-Joint Count and C-reactive protein [DAS28-CRP] less than or equal to [≤]3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to methylprednisolone (MP) tablets, by mouth (PO). MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be greater than or equal to [≥]1 mg and ≤20 mg per day [mg/day]), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment
11033732|NCT01219933|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
11033733|NCT01219933|EG000|Reported Event|Noninterventional Phase|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week according to local standard of care and at the investigator's discretion (or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months.
11033734|NCT01219933|EG001|Reported Event|Interventional Phase|All participants who maintained LDA from V2 to V3 were included in the interventional phase for reduction of GC. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
11033735|NCT01219959|BG000|Baseline|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
11033736|NCT01219959|BG001|Baseline|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
11033737|NCT01219959|BG002|Baseline|Total|Total of all reporting groups
11033738|NCT01219959|FG000|Participant Flow|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
11033739|NCT01219959|FG001|Participant Flow|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
11033740|NCT01219959|OG000|Outcome|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
11033741|NCT01219959|OG001|Outcome|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
11033742|NCT01219959|EG000|Reported Event|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
11033743|NCT01219959|EG001|Reported Event|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
11033744|NCT01219985|BG000|Baseline|Investigation Arm|Patients included in the trial. n=50
11033745|NCT01219985|FG000|Participant Flow|Investigation Arm|Patients definitely included in the trial. All these patients underwent non-gated and gated PET/CT as well as hepatic surgery. In addition, histological analysis of the resected lesions were also obtained.
11033746|NCT01219985|OG000|Outcome|Ungated Per-lesion Sensitivity|Ungated PET images results were compared with pathological analyses
11033747|NCT01219985|OG001|Outcome|CT-Based Per-lesion Sensitivity|CT-Based PET images results were compared with pathological analyses
11033748|NCT01219985|OG000|Outcome|SUVmax Study|SUVmax measurement for each lesion in Ungated and CT-Based PET images. SUVmax was obtained automatically in a volume of interest encompassing the entire lesion
11033749|NCT01219985|EG000|Reported Event|Investigation Arm|Patients included in the trial. n=50
11033750|NCT01220024|BG000|Baseline|2, 5x5cm Bupivacaine Collagen Sponges|Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge
11033751|NCT01220024|BG001|Baseline|2, Placebo Collagen Sponges|Placebo collagen Sponge: Drug: Placebo Collagen Sponge
11033752|NCT01220024|BG002|Baseline|Total|Total of all reporting groups
11033753|NCT01220024|FG000|Participant Flow|2, 5x5cm Bupivacaine Collagen Sponges|Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge - Two 5 × 5-cm bupivacaine sponges each containing 75 mg of Type I collagen and 100 mg bupivacaine hydrochloride,
11033754|NCT01220024|FG001|Participant Flow|2, Placebo Collagen Sponges|Placebo collagen Sponge: Drug: Placebo Collagen Sponge - Two 5 × 5-cm placebo sponges each containing 75 mg of Type I collagen.
11033755|NCT01220024|OG000|Outcome|2, 5x5cm Bupivacaine Collagen Sponges|Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge
11033756|NCT01220024|OG001|Outcome|2, Placebo Collagen Sponges|Placebo collagen Sponge: Drug: Placebo Collagen Sponge
11033757|NCT01220024|EG000|Reported Event|2, 5x5cm Bupivacaine Collagen Sponges|Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge
11033758|NCT01220024|EG001|Reported Event|2, Placebo Collagen Sponges|Placebo collagen Sponge: Drug: Placebo Collagen Sponge
11033759|NCT01220128|BG000|Baseline|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
11033760|NCT01220128|BG001|Baseline|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.
11033761|NCT01220128|BG002|Baseline|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.
11033762|NCT01220128|BG003|Baseline|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033763|NCT01220128|BG004|Baseline|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033764|NCT01220128|BG005|Baseline|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
11033765|NCT01220128|BG006|Baseline|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033766|NCT01220128|BG007|Baseline|Total|Total of all reporting groups
10887079|NCT00498615|FG003|Participant Flow|Sequence 4|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
10887080|NCT00498615|FG004|Participant Flow|Sequence 5|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
11033767|NCT01220128|FG000|Participant Flow|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
11033768|NCT01220128|FG001|Participant Flow|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.
11033769|NCT01220128|FG002|Participant Flow|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.
11033770|NCT01220128|FG003|Participant Flow|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033771|NCT01220128|FG004|Participant Flow|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033772|NCT01220128|FG005|Participant Flow|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
11033773|NCT01220128|FG006|Participant Flow|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033774|NCT01220128|OG000|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule
11033775|NCT01220128|OG001|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.
11033776|NCT01220128|OG002|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.
11033777|NCT01220128|OG003|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033778|NCT01220128|OG004|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033779|NCT01220128|OG005|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
11033780|NCT01220128|OG006|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033781|NCT01220128|OG000|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
11033782|NCT01220128|EG000|Reported Event|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
11033783|NCT01220128|EG001|Reported Event|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.
11033784|NCT01220128|EG002|Reported Event|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.
11033785|NCT01220128|EG003|Reported Event|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033786|NCT01220128|EG004|Reported Event|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11033787|NCT01220128|EG005|Reported Event|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
11033788|NCT01220128|EG006|Reported Event|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
11225870|NCT02370602|FG003|Participant Flow|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
11033789|NCT01220167|BG000|Baseline|Sequence ABC|Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water).
11033790|NCT01220167|BG001|Baseline|Sequence BCA|Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water).
11033791|NCT01220167|BG002|Baseline|Sequence CAB|Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water).
11033792|NCT01220167|BG003|Baseline|Total|Total of all reporting groups
11033793|NCT01220167|FG000|Participant Flow|Sequence ABC|Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water).
11225871|NCT02370602|FG004|Participant Flow|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11033794|NCT01220167|FG001|Participant Flow|Sequence BCA|Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water).
11033795|NCT01220167|FG002|Participant Flow|Sequence CAB|Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water).
11033796|NCT01220167|OG000|Outcome|Ondansetron ODFS With or Without Water and Zofran ODT|Single dose of Ondansetron ODFS 8 mg film administered with and then without water and Zofran 8 mg administered without water
11033797|NCT01220167|OG000|Outcome|Ondansetron ODFS With and Without Water and Zofran ODT|Single dose of Ondansetron ODFS 8 mg film with and again without water and Zofran 8 mg without water
11033798|NCT01220167|OG000|Outcome|Ondansetron ODFS With and Without Water and Zofran ODT|Single dose of Ondansetron ODFS 8 mg film with water and without water and Zofran 8 mg without water
11033799|NCT01220167|EG000|Reported Event|ODFS 8 mg With and Without Water and Zofran ODT Without Water|"Single dose of ondansetron ODFS 8 mg film administered with and without water and Zofran 8 mg administered without water in randomized sequence.~Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments."
11033800|NCT01220180|BG000|Baseline|Pregabalin: Epilepsy|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy.
11033801|NCT01220180|BG001|Baseline|Pregabalin: Neuropathic Pain|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
11033802|NCT01220180|BG002|Baseline|Pregabalin: Fibromyalgia|Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia.
11033803|NCT01220180|BG003|Baseline|Total|Total of all reporting groups
11033804|NCT01220180|FG000|Participant Flow|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
11033805|NCT01220180|OG000|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
11033806|NCT01220180|EG000|Reported Event|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
11033807|NCT01220297|BG000|Baseline|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
11033808|NCT01220297|BG001|Baseline|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
10887081|NCT00498615|FG005|Participant Flow|Sequence 6|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
11033809|NCT01220297|BG002|Baseline|Total|Total of all reporting groups
11033810|NCT01220297|FG000|Participant Flow|Graft-vs-Host Disease (GvHD) Prophlyaxis|Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative
11033811|NCT01220297|OG000|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
11033812|NCT01220297|OG001|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
11033813|NCT01220297|EG000|Reported Event|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
11033814|NCT01220297|EG001|Reported Event|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
11033815|NCT01220401|BG000|Baseline|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
11033816|NCT01220401|FG000|Participant Flow|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
11033817|NCT01220401|OG000|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
11033818|NCT01220401|EG000|Reported Event|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
11225872|NCT02370602|FG005|Participant Flow|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
11033819|NCT01220414|BG000|Baseline|Naltrexone Then Placebo|All participants completed both naltrexone and placebo conditions
11033820|NCT01220414|BG001|Baseline|Placebo Then Naltrxone|
11033821|NCT01220414|BG002|Baseline|Total|Total of all reporting groups
11033822|NCT01220414|FG000|Participant Flow|Males, Naltrexone Then Placebo|
11033823|NCT01220414|FG001|Participant Flow|Males, Placebo Then Naltrexone|
11033824|NCT01220414|FG002|Participant Flow|Females, Naltrexone Then Placebo|
11033825|NCT01220414|FG003|Participant Flow|Females, Placebo Then Naltrexone|
11033826|NCT01220414|OG000|Outcome|Men, Placebo|
11033827|NCT01220414|OG001|Outcome|Women, Placebo|
11033828|NCT01220414|OG002|Outcome|Men, Naltrexone|
11033829|NCT01220414|OG003|Outcome|Females, Naltrexone|
11033830|NCT01220414|EG000|Reported Event|Naltrexone and Placebo|Participants completed both naltrexone and placebo conditions
11033831|NCT01220466|BG000|Baseline|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to~+9.00 D, with cylinder between 0.00 and +6.00 D."
11033832|NCT01220466|BG001|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
11033833|NCT01220466|BG002|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
11033834|NCT01220466|BG003|Baseline|Total|Total of all reporting groups
11033835|NCT01220466|FG000|Participant Flow|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to~+9.00 D, with cylinder between 0.00 and +6.00 D."
11033836|NCT01220466|FG001|Participant Flow|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
11033837|NCT01220466|FG002|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
11033838|NCT01220466|OG000|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
11033839|NCT01220466|OG001|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
11033840|NCT01220466|OG002|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
11033841|NCT01220466|EG000|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
11033842|NCT01220466|EG001|Reported Event|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
10887082|NCT00498615|OG000|Outcome|40 mg Fasudil|This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil 40 mg administered 2 hours before a standardized cold challenge participant and researchers will not know what is received on the testing day.
11033843|NCT01220466|EG002|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
11033844|NCT01220557|BG000|Baseline|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
11033845|NCT01220557|BG001|Baseline|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
11033846|NCT01220557|BG002|Baseline|Total|Total of all reporting groups
11033847|NCT01220557|FG000|Participant Flow|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
11033848|NCT01220557|FG001|Participant Flow|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
11033849|NCT01220557|OG000|Outcome|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
11033850|NCT01220557|OG001|Outcome|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
11033851|NCT01220557|EG000|Reported Event|PRIMAS Group|"PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material~PRIMAS: PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material"
11033852|NCT01220557|EG001|Reported Event|Control Group|"The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.~DTTP: The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material."
11033853|NCT01220609|BG000|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
11033854|NCT01220609|FG000|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
11033855|NCT01220609|OG000|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
11033856|NCT01220609|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
11033857|NCT01220609|OG001|Outcome|Grade 1 (CTCAE v 4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
11033858|NCT01220609|OG002|Outcome|Grade 2 (CTCAE v 4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
11033859|NCT01220609|OG003|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
11033860|NCT01220609|OG004|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
11033861|NCT01220609|OG005|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
11033862|NCT01220609|EG000|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
11033863|NCT01220687|BG000|Baseline|Placebo 20ppm|"Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study~Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen."
11033864|NCT01220687|BG001|Baseline|iNO 20 Ppm|"Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study~iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen."
11033865|NCT01220687|BG002|Baseline|Total|Total of all reporting groups
11033866|NCT01220687|FG000|Participant Flow|Placebo 20ppm|"Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study~Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen."
11033867|NCT01220687|FG001|Participant Flow|iNO 20 Ppm|"Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study~iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen."
11033868|NCT01220687|OG000|Outcome|Placebo 20ppm|"Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study~Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen."
11033869|NCT01220687|OG001|Outcome|iNO 20 Ppm|"Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study~iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen."
11033870|NCT01220687|EG000|Reported Event|Placebo 20ppm|"Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study~Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen."
11033871|NCT01220687|EG001|Reported Event|iNO 20 Ppm|"Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study~iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen."
11033872|NCT01220726|BG000|Baseline|Botox|"200U onabotulinumtoxinA (botox)~Botox: Botox injection"
11033873|NCT01220726|BG001|Baseline|Placebo|"200U Saline~Placebo: Placebo injection"
11033874|NCT01220726|BG002|Baseline|Total|Total of all reporting groups
11033875|NCT01220726|FG000|Participant Flow|Botox|"200U onabotulinumtoxinA (botox)~Botox: Botox injection"
11033876|NCT01220726|FG001|Participant Flow|Placebo|"200U Saline~Placebo: Placebo injection"
11033877|NCT01220726|OG000|Outcome|Placebo|"200U Saline~Placebo: Placebo injection"
11033878|NCT01220726|OG001|Outcome|Botox|"200U onabotulinumtoxinA (botox)~Botox: Botox injection"
10887083|NCT00498615|OG001|Outcome|80 mg Fasudil|participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
11033879|NCT01220726|EG000|Reported Event|Botox|Number of adverse events that occurred in the botox arm
11033880|NCT01220726|EG001|Reported Event|Placebo|Number of adverse events that occurred in the placebo arm
11033881|NCT01220739|BG000|Baseline|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
11033882|NCT01220739|BG001|Baseline|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
11033883|NCT01220739|BG002|Baseline|Total|Total of all reporting groups
11033884|NCT01220739|FG000|Participant Flow|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
11033885|NCT01220739|FG001|Participant Flow|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
11033886|NCT01220739|OG000|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
11033887|NCT01220739|OG001|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
11033888|NCT01220739|EG000|Reported Event|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
11033889|NCT01220739|EG001|Reported Event|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
11033890|NCT01220856|BG000|Baseline|Reparixin|"Reparixin + Immunosuppression~Reparixin was administered at a dose of 2.772 mg/kg body weight/hour for 7 days (168 hours) at each transplant. It was administered as a continuous IV infusion into a (high-flow) central vein. Investigational Product infusion was to begin approximately 12 hours (range between 6 to 16 hours) before each pancreatic islet infusion was started. The Investigator identified the time to start study drug administration.~Reparixin was given to all patients of this arm using the same dosing solution (reparixin 11.00 mg/mL), but the pump rate was adjusted to provide an infusion rate of approximately 0.25 mL/kg/hour.~For immunosoppression regimen see the other arm description.~Reparixin: Reparixin + immunosuppression"
11225873|NCT02370602|OG000|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
10887084|NCT00498615|OG002|Outcome|Placebo|participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
11033891|NCT01220856|BG001|Baseline|No Experimental Intervention|Immunosuppression only. Induction: First islet infusion: anti-thymocyte globulin (ATG), administered IV (central vein) at the dose of 1.5 mg/kg on Day -1, 0, 1, and 2 of islet infusion. The first ATG injection was preceded by a bolus IV injection of 500 mg methylprednisolone. Induction for the second islet infusion was to be administered per center practice. Maintenance: Mycophenolate mofetil (MMF), administered orally at the dose of 1 g twice a day, starting on Day -1 of the first islet infusion; Tacrolimus, administered orally starting on Day -1 of the first islet infusion at a dose of 0.087 mg/kg twice a day. Thereafter, dosing was to be targeted to blood trough levels of 8 to 10 ng/mL. Administration continued up to Month 3 after the first transplant. Rapamycin was to replace tacrolimus from Month 3 after the first transplant. It was to be administered orally at the starting dose of 0.1 mg/kg once a day, then targeted to a blood trough level of 10 to 12 ng/mL.
11033892|NCT01220856|BG002|Baseline|Total|Total of all reporting groups
11033893|NCT01220856|FG000|Participant Flow|Reparixin|"Reparixin + Immunosuppression~Reparixin was administered at a dose of 2.772 mg/kg body weight/hour for 7 days (168 hours) at each transplant. It was administered as a continuous IV infusion into a (high-flow) central vein. Investigational Product infusion was to begin approximately 12 hours (range between 6 to 16 hours) before each pancreatic islet infusion was started. The Investigator identified the time to start study drug administration.~Reparixin was given to all patients of this arm using the same dosing solution (reparixin 11.00 mg/mL), but the pump rate was adjusted to provide an infusion rate of approximately 0.25 mL/kg/hour.~For immunosuppression regimen see the other arm description.~Reparixin: Reparixin + immunosuppression"
11033894|NCT01220856|FG001|Participant Flow|No Experimental Intervention|Immunosuppression only. Induction: First islet infusion: anti-thymocyte globulin (ATG), administered IV (central vein) at the dose of 1.5 mg/kg on Day -1, 0, 1, and 2 of islet infusion. The first ATG injection was preceded by a bolus IV injection of 500 mg methylprednisolone. Induction for the second islet infusion was to be administered per center practice. Maintenance: Mycophenolate mofetil (MMF), administered orally at the dose of 1 g twice a day, starting on Day -1 of the first islet infusion; Tacrolimus, administered orally starting on Day -1 of the first islet infusion at a dose of 0.087 mg/kg twice a day. Thereafter, dosing was to be targeted to blood trough levels of 8 to 10 ng/mL. Administration continued up to Month 3 after the first transplant. Rapamycin was to replace tacrolimus from Month 3 after the first transplant. It was to be administered orally at the starting dose of 0.1 mg/kg once a day, then targeted to a blood trough level of 10 to 12 ng/mL.
11033895|NCT01220856|OG000|Outcome|Reparixin|"Reparixin + Immunosuppression~Reparixin was administered at a dose of 2.772 mg/kg body weight/hour for 7 days (168 hours) at each transplant. It was administered as a continuous IV infusion into a (high-flow) central vein. Investigational Product infusion was to begin approximately 12 hours (range between 6 to 16 hours) before each pancreatic islet infusion was started. The Investigator identified the time to start study drug administration.~Reparixin was given to all patients of this arm using the same dosing solution (reparixin 11.00 mg/mL), but the pump rate was adjusted to provide an infusion rate of approximately 0.25 mL/kg/hour.~For immunosuppression regimen see the other arm description.~Reparixin: Reparixin + immunosuppression"
11033896|NCT01220856|OG001|Outcome|No Experimental Intervention|"Immunosuppression only. Induction: First islet infusion: anti-thymocyte globulin (ATG), administered IV (central vein) at the dose of 1.5 mg/kg on Day -1, 0, 1, and 2 of islet infusion. The first ATG injection was preceded by a bolus IV injection of 500 mg methylprednisolone. Induction for the second islet infusion was to be administered per center practice. Maintenance: Mycophenolate mofetil (MMF), administered orally at the dose of 1 g twice a day, starting on Day -1 of the first islet infusion; Tacrolimus, administered orally starting on Day -1 of the first islet infusion at a dose of 0.087 mg/kg twice a day. Thereafter, dosing was to be targeted to blood trough levels of 8 to 10 ng/mL. Administration continued up to Month 3 after the first transplant.~Rapamycin was to replace tacrolimus from Month 3 after the first transplant. It was to be administered orally at the starting dose of 0.1 mg/kg once a day, then targeted to a blood trough level of 10 to 12 ng/mL."
11033897|NCT01220856|OG001|Outcome|No Experimental Intervention|Immunosuppression only. Induction: First islet infusion: anti-thymocyte globulin (ATG), administered IV (central vein) at the dose of 1.5 mg/kg on Day -1, 0, 1, and 2 of islet infusion. The first ATG injection was preceded by a bolus IV injection of 500 mg methylprednisolone. Induction for the second islet infusion was to be administered per center practice. Maintenance: Mycophenolate mofetil (MMF), administered orally at the dose of 1 g twice a day, starting on Day -1 of the first islet infusion; Tacrolimus, administered orally starting on Day -1 of the first islet infusion at a dose of 0.087 mg/kg twice a day. Thereafter, dosing was to be targeted to blood trough levels of 8 to 10 ng/mL. Administration continued up to Month 3 after the first transplant. Rapamycin was to replace tacrolimus from Month 3 after the first transplant. It was to be administered orally at the starting dose of 0.1 mg/kg once a day, then targeted to a blood trough level of 10 to 12 ng/mL.
11033898|NCT01220856|OG000|Outcome|Reparixin|"Reparixin + Immunosuppression~Reparixin was administered at a dose of 2.772 mg/kg body weight/hour for 7 days (168 hours) at each transplant. It was administered as a continuous IV infusion into a (high-flow) central vein.~Investigational Product infusion was to begin approximately 12 hours (range between 6 to 16 hours) before each pancreatic islet infusion was started. The Investigator identified the time to start study drug administration.~Reparixin was given to all patients of this arm using the same dosing solution (reparixin 11.00 mg/mL), but the pump rate was adjusted to provide an infusion rate of approximately 0.25 mL/kg/hour.~For immunosuppression regimen see the other arm description.~Reparixin: Reparixin + immunosuppression"
11225874|NCT02370602|OG001|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
10887085|NCT00498615|OG000|Outcome|80 mg Fasudil|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil In this arm participants received 80 mg of Fasudil 2 hours before a standardized cold challenge.~Men and women between ages 18-80 years with a clinical diagnosis of Raynauds Phenomenon secondary to Scleroderma were eligible for the study."
10887086|NCT00498615|OG001|Outcome|40 mg Fasudil|In this group participants received 40mg of Fasudil 2 hours before cold challenge
11033899|NCT01220856|OG001|Outcome|No Experimental Intervention|"Immunosuppression only. Induction: First islet infusion: anti-thymocyte globulin (ATG), administered IV (central vein) at the dose of 1.5 mg/kg on Day -1, 0, 1, and 2 of islet infusion. The first ATG injection was preceded by a bolus IV injection of 500 mg methylprednisolone. Induction for the second islet infusion was to be administered per center practice.~Maintenance: Mycophenolate mofetil (MMF), administered orally at the dose of 1 g twice a day, starting on Day -1 of the first islet infusion; Tacrolimus, administered orally starting on Day -1 of the first islet infusion at a dose of 0.087 mg/kg twice a day. Thereafter, dosing was to be targeted to blood trough levels of 8 to 10 ng/mL. Administration continued up to Month 3 after the first transplant.~Rapamycin was to replace tacrolimus from Month 3 after the first transplant. It was to be administered orally at the starting dose of 0.1 mg/kg once a day, then targeted to a blood trough level of 10 to 12 ng/mL."
11033900|NCT01220856|EG000|Reported Event|Reparixin|"Reparixin + Immunosuppression~Reparixin was administered at a dose of 2.772 mg/kg body weight/hour for 7 days (168 hours) at each transplant. It was administered as a continuous IV infusion into a (high-flow) central vein. Investigational Product infusion was to begin approximately 12 hours (range between 6 to 16 hours) before each pancreatic islet infusion was started. The Investigator identified the time to start study drug administration.~Reparixin was given to all patients of this arm using the same dosing solution (reparixin 11.00 mg/mL), but the pump rate was adjusted to provide an infusion rate of approximately 0.25 mL/kg/hour.~For immunosoppression regimen see the other arm description.~Reparixin: Reparixin + immunosuppression"
11033901|NCT01220856|EG001|Reported Event|No Experimental Intervention|Immunosuppression only. Induction: First islet infusion: anti-thymocyte globulin (ATG), administered IV (central vein) at the dose of 1.5 mg/kg on Day -1, 0, 1, and 2 of islet infusion. The first ATG injection was preceded by a bolus IV injection of 500 mg methylprednisolone. Induction for the second islet infusion was to be administered per center practice. Maintenance: Mycophenolate mofetil (MMF), administered orally at the dose of 1 g twice a day, starting on Day -1 of the first islet infusion; Tacrolimus, administered orally starting on Day -1 of the first islet infusion at a dose of 0.087 mg/kg twice a day. Thereafter, dosing was to be targeted to blood trough levels of 8 to 10 ng/mL. Administration continued up to Month 3 after the first transplant. Rapamycin was to replace tacrolimus from Month 3 after the first transplant. It was to be administered orally at the starting dose of 0.1 mg/kg once a day, then targeted to a blood trough level of 10 to 12 ng/mL.
11033902|NCT01220869|BG000|Baseline|Degarelix|Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose)
11033903|NCT01220869|FG000|Participant Flow|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
11033904|NCT01220869|OG000|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
11033905|NCT01220869|EG000|Reported Event|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
11033906|NCT01220973|BG000|Baseline|Atorvastatin and Celecoxib|"atorvastatin calcium~celecoxib~laboratory biomarker analysis"
11033907|NCT01220973|FG000|Participant Flow|Atorvastatin and Celecoxib|"atorvastatin calcium~celecoxib~laboratory biomarker analysis"
11033908|NCT01220973|OG000|Outcome|Atorvastatin and Celecoxib|"atorvastatin calcium~celecoxib~laboratory biomarker analysis"
11033909|NCT01220973|EG000|Reported Event|Atorvastatin and Celecoxib|"atorvastatin calcium~celecoxib~laboratory biomarker analysis"
11033910|NCT01220999|BG000|Baseline|Cohort 1|Subjects received an initial loading dose of 111^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033911|NCT01220999|BG001|Baseline|Cohort 2|Subjects received an initial loading dose of 111^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033912|NCT01220999|BG002|Baseline|Cohort 3|Subjects received an initial loading dose of 111^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033913|NCT01220999|BG003|Baseline|Cohort 4|Subjects received an initial loading dose of 111^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033914|NCT01220999|BG004|Baseline|Cohort 5|Subjects received an initial loading dose of 111^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033915|NCT01220999|BG005|Baseline|Total|Total of all reporting groups
11033916|NCT01220999|FG000|Participant Flow|Cohort 1|Subjects received an initial loading dose of 111^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033917|NCT01220999|FG001|Participant Flow|Cohort 2|Subjects received an initial loading dose of 111^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
10887087|NCT00498615|OG002|Outcome|Placebo|In this group participants received placebo 2 hours before cold challenge.
11033918|NCT01220999|FG002|Participant Flow|Cohort 3|Subjects received an initial loading dose of 111^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033919|NCT01220999|FG003|Participant Flow|Cohort 4|Subjects received an initial loading dose of 111^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033920|NCT01220999|FG004|Participant Flow|Cohort 5|Subjects received an initial loading dose of 111^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033921|NCT01220999|OG000|Outcome|Cohort 1|Subjects received an initial loading dose of 111^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033922|NCT01220999|OG001|Outcome|Cohort 2|Subjects received an initial loading dose of 111^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033923|NCT01220999|OG002|Outcome|Cohort 3|Subjects received an initial loading dose of 111^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033924|NCT01220999|OG003|Outcome|Cohort 4|Subjects received an initial loading dose of 111^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033925|NCT01220999|OG004|Outcome|Cohort 5|Subjects received an initial loading dose of 111^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033926|NCT01220999|EG000|Reported Event|Cohort 1|Subjects received an initial loading dose of 111^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033927|NCT01220999|EG001|Reported Event|Cohort 2|Subjects received an initial loading dose of 111^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033928|NCT01220999|EG002|Reported Event|Cohort 3|Subjects received an initial loading dose of 111^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033929|NCT01220999|EG003|Reported Event|Cohort 4|Subjects received an initial loading dose of 111^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033930|NCT01220999|EG004|Reported Event|Cohort 5|Subjects received an initial loading dose of 111^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
11033931|NCT01221090|BG000|Baseline|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
11033932|NCT01221090|BG001|Baseline|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
11033933|NCT01221090|BG002|Baseline|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
11033934|NCT01221090|BG003|Baseline|Control|Usual Care
11033935|NCT01221090|BG004|Baseline|Total|Total of all reporting groups
11033936|NCT01221090|FG000|Participant Flow|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
11033937|NCT01221090|FG001|Participant Flow|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
11033938|NCT01221090|FG002|Participant Flow|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
11033939|NCT01221090|FG003|Participant Flow|Control|Usual Care
11033940|NCT01221090|OG000|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
11033941|NCT01221090|OG001|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
11033942|NCT01221090|OG002|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
11033943|NCT01221090|OG003|Outcome|Control|Usual Care
11033944|NCT01221090|EG000|Reported Event|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
11033945|NCT01221090|EG001|Reported Event|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
11033946|NCT01221090|EG002|Reported Event|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
11033947|NCT01221090|EG003|Reported Event|Control|Usual Care
11033948|NCT01221181|BG000|Baseline|Eculizumab|Patients will receive Eculizumab and be observed for 60 minutes after the first 5 infusions, then 30 minutes after all subsequent infusions.
11033949|NCT01221181|FG000|Participant Flow|Eculizumab|Patients will receive Eculizumab and be observed for 60 minutes after the first 5 infusions, then 30 minutes after all subsequent infusions.
11033950|NCT01221181|OG000|Outcome|Eculizumab|"Eculizumab 900 mg IV one a week for 4 weeks, 1200 mg IV week 5, then 1200 mg IV every 2 weeks through week 53.~Eculizumab: 900 mg IV once a week x 4 weeks, 1200 mg IV week 5, then 1200 mg IV every 2 weeks through week 53.~Patients will be observed for 60 minutes after the first 5 infusions, then 30 minutes after all subsequent infusions. Patients will not be allowed to take other immunomodulatory therapies during the study period but will continue on their other non-immunomodulatory therapies (e.g. ACE inhibitors, -statins, aspirin) without modifications unless clinically indicated. All patients, if unvaccinated, will be given N. meningitidis vaccine at least two weeks prior to first eculizumab exposure. All female patients of childbearing potential will be asked to use adequate contraception methods during treatment and up to 5 months following discontinuation of eculizumab treatment."
11033951|NCT01221181|EG000|Reported Event|Eculizumab|Patients will receive Eculizumab and be observed for 60 minutes after the first 5 infusions, then 30 minutes after all subsequent infusions.
11033952|NCT01221194|BG000|Baseline|PFC Stockings|"The stocking therapy group will be given PFC shear reducing stockings to wear.~PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases."
11033953|NCT01221194|BG001|Baseline|Standard Therapy|"Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.~Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear."
11033954|NCT01221194|BG002|Baseline|Total|Total of all reporting groups
11033955|NCT01221194|FG000|Participant Flow|PFC Stockings|"The stocking therapy group will be given PFC shear reducing stockings to wear.~PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases."
11033956|NCT01221194|FG001|Participant Flow|Standard Therapy|"Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.~Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear."
11033957|NCT01221194|OG000|Outcome|PFC Stockings|"The stocking therapy group will be given PFC shear reducing stockings to wear.~PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases."
11033958|NCT01221194|OG001|Outcome|Standard Therapy|"Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.~Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear."
11033959|NCT01221194|EG000|Reported Event|PFC Stockings|"The stocking therapy group will be given PFC shear reducing stockings to wear.~PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases."
11033960|NCT01221194|EG001|Reported Event|Standard Therapy|"Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.~Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear."
10887348|NCT00499915|FG000|Participant Flow|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
11033961|NCT01221207|BG000|Baseline|Instant Total Contact Cast (ITCC)|"The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician.~Instant Total Contact Cast (ITCC): The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician."
11033962|NCT01221207|BG001|Baseline|Device - Total Contact Cast (TCC)|"A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing.~Total Contact Cast: A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing."
11033963|NCT01221207|BG002|Baseline|Removable Cast Walker (RCW)|"The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot.~Removable Cast Walker (RCW): The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot."
11033964|NCT01221207|BG003|Baseline|Total|Total of all reporting groups
11033965|NCT01221207|FG000|Participant Flow|Instant Total Contact Cast (ITCC)|"The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician.~Instant Total Contact Cast (ITCC): The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician."
11033966|NCT01221207|FG001|Participant Flow|Device - Total Contact Cast (TCC)|"A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing.~Total Contact Cast: A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing."
11033967|NCT01221207|FG002|Participant Flow|Removable Cast Walker (RCW)|"The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot.~Removable Cast Walker (RCW): The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot."
11033968|NCT01221207|OG000|Outcome|Instant Total Contact Cast (ITCC)|"The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician.~Instant Total Contact Cast (ITCC): The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician."
11033969|NCT01221207|OG001|Outcome|Device - Total Contact Cast (TCC)|"A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing.~Total Contact Cast: A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing."
11033970|NCT01221207|OG002|Outcome|Removable Cast Walker (RCW)|"The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot.~Removable Cast Walker (RCW): The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot."
11033971|NCT01221207|EG000|Reported Event|Instant Total Contact Cast (ITCC)|"The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician.~Instant Total Contact Cast (ITCC): The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician."
11033972|NCT01221207|EG001|Reported Event|Device - Total Contact Cast (TCC)|"A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing.~Total Contact Cast: A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing."
11033973|NCT01221207|EG002|Reported Event|Removable Cast Walker (RCW)|"The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot.~Removable Cast Walker (RCW): The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot."
11033974|NCT01221233|BG000|Baseline|NMES AND Stabilization Exercises|"Neuromuscular Electrical Stimulation and Lumbar Stabilization Exercises~Neuromuscular Electrical Stimulation: Neuromuscular Electrical Stimulation (NMES) to the low back muscles (i.e. spinal extensors) will be applied at the parameters previously used in the knee muscles at the maximal tolerable intensity, which results in a full, sustained isometric contraction of the back muscles. Pad placement will be just below the waist line, with 2, 2X2 inch pads, on either side of the spine. Participants will be positioned on their belly with 2 pillows under their stomach to level the spine and secured to a table using a belt that crosses the buttock.~The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees)."
11033975|NCT01221233|BG001|Baseline|Moist Heat AND Stabilization Exercises|"Moist Heat and Lumbar Stabilization Exercises~Moist Heat: For participants who do not receive NMES, moist heat will be applied for 15 minutes in a position of comfort for the participant.~The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees)."
11033976|NCT01221233|BG002|Baseline|Total|Total of all reporting groups
11033977|NCT01221233|FG000|Participant Flow|NMES AND Stabilization Exercises|"Neuromuscular Electrical Stimulation and Lumbar Stabilization Exercises~Neuromuscular Electrical Stimulation: Neuromuscular Electrical Stimulation (NMES) to the low back muscles (i.e. spinal extensors) will be applied at the parameters previously used in the knee muscles at the maximal tolerable intensity, which results in a full, sustained isometric contraction of the back muscles. Pad placement will be just below the waist line, with 2, 2X2 inch pads, on either side of the spine. Participants will be positioned on their belly with 2 pillows under their stomach to level the spine and secured to a table using a belt that crosses the buttock.~The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees)."
11033978|NCT01221233|FG001|Participant Flow|Moist Heat AND Stabilization Exercises|"Moist Heat and Lumbar Stabilization Exercises~Moist Heat: For participants who do not receive NMES, moist heat will be applied for 15 minutes in a position of comfort for the participant.~The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees)."
11225875|NCT02370602|OG002|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
11033979|NCT01221233|OG000|Outcome|NMES AND Stabilization Exercises|"Neuromuscular Electrical Stimulation (NMES) and Lumbar Stabilization Exercises~Participants received a physical therapy intervention 2 times per week for 6 weeks that consisted of a lumbar stabilization exercise program targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees) followed by NMES set to portable 300PV unit by EMPI (St. Paul, MN) was set to the following: 50 bursts per second, 12 seconds of contraction, 50 seconds of rest, a 2 second ramp, 400 microseconds, and a treatment time of 20 minutes"
11033980|NCT01221233|OG001|Outcome|Moist Heat AND Stabilization Exercises|Participants received a physical therapy intervention 2 times per week for 6 weeks that consisted of a lumbar stabilization exercise program targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees) followed by 20 minutes of moist heat to the low back region.
11033981|NCT01221233|EG000|Reported Event|NMES AND Stabilization Exercises|Neuromuscular Electrical Stimulation (NMES) and Lumbar Stabilization Exercises
11033982|NCT01221233|EG001|Reported Event|Moist Heat AND Stabilization Exercises|Moist Heat and Lumbar Stabilization Exercises
11033983|NCT01221272|BG000|Baseline|All Participants|"Baseline characteristics were analyzed as a single group (Safety Analysis Set). All participants were assigned to complete the same treatment periods in the same manner.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
11033984|NCT01221272|FG000|Participant Flow|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
11033985|NCT01221272|FG001|Participant Flow|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
11033986|NCT01221272|OG000|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
11033987|NCT01221272|OG001|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
11033988|NCT01221272|OG000|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
11033989|NCT01221272|OG001|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
11033990|NCT01221272|EG000|Reported Event|Onset Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events for which the last dosed treatment was ranolazine, ie, events with onset during the ranolazine treatment period or during post-ranolazine treatment period follow-up.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
11033991|NCT01221272|EG001|Reported Event|Onset Following Placebo|"This reporting group includes participants dosed with placebo and their events for which the last dosed treatment was placebo, ie, events with onset during the placebo treatment period or during post-placebo treatment period follow-up.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
11033992|NCT01221272|EG002|Reported Event|Onset at Any Time Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events with onset at any time following ranolazine treatment.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
11033993|NCT01221285|BG000|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
11033994|NCT01221285|FG000|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
11033995|NCT01221285|OG000|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
11033996|NCT01221285|EG000|Reported Event|Experimental: German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
11033997|NCT01221298|BG000|Baseline|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
11033998|NCT01221298|FG000|Participant Flow|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
11033999|NCT01221298|OG000|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
11034000|NCT01221298|EG000|Reported Event|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
11034001|NCT01221311|BG000|Baseline|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
11034002|NCT01221311|BG001|Baseline|Plastic Stent|Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
11034003|NCT01221311|BG002|Baseline|Total|Total of all reporting groups
11034004|NCT01221311|FG000|Participant Flow|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
11034005|NCT01221311|FG001|Participant Flow|Plastic Stent|"Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).~Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal"
11034006|NCT01221311|OG000|Outcome|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
11034007|NCT01221311|OG001|Outcome|Plastic Stent|"Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).~Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal"
11034008|NCT01221311|EG000|Reported Event|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
11034009|NCT01221311|EG001|Reported Event|Plastic Stent|Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
11034010|NCT01221350|BG000|Baseline|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
11034011|NCT01221350|BG001|Baseline|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
11034012|NCT01221350|BG002|Baseline|Total|Total of all reporting groups
11034013|NCT01221350|FG000|Participant Flow|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
11034014|NCT01221350|FG001|Participant Flow|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
11034015|NCT01221350|OG000|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
11034016|NCT01221350|OG001|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
11034017|NCT01221350|OG000|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
11034018|NCT01221350|OG001|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
11034019|NCT01221350|EG000|Reported Event|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
11034020|NCT01221350|EG001|Reported Event|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
11034021|NCT01221363|BG000|Baseline|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
11034022|NCT01221363|BG001|Baseline|Control Group|No intervention control group
11034023|NCT01221363|BG002|Baseline|Total|Total of all reporting groups
11034024|NCT01221363|FG000|Participant Flow|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
11034025|NCT01221363|FG001|Participant Flow|Control Group|No intervention control group
11034026|NCT01221363|OG000|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
11034027|NCT01221363|OG001|Outcome|Control Group|No intervention control group
11034028|NCT01221363|EG000|Reported Event|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
11034029|NCT01221363|EG001|Reported Event|Control Group|No intervention control group
11034030|NCT01221441|BG000|Baseline|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
11034031|NCT01221441|BG001|Baseline|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
11034032|NCT01221441|BG002|Baseline|Total|Total of all reporting groups
11034033|NCT01221441|FG000|Participant Flow|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
11034034|NCT01221441|FG001|Participant Flow|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
11034035|NCT01221441|OG000|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
11034036|NCT01221441|OG001|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
11034037|NCT01221441|EG000|Reported Event|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
11034038|NCT01221441|EG001|Reported Event|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
11034039|NCT01221597|BG000|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034040|NCT01221597|BG001|Baseline|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
11034041|NCT01221597|BG002|Baseline|Total|Total of all reporting groups
11034042|NCT01221597|FG000|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034043|NCT01221597|FG001|Participant Flow|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
11034044|NCT01221597|OG000|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034045|NCT01221597|OG001|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
11034046|NCT01221597|OG001|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
11034047|NCT01221597|EG000|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034048|NCT01221597|EG001|Reported Event|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
11034049|NCT01221623|BG000|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034050|NCT01221623|BG001|Baseline|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034051|NCT01221623|BG002|Baseline|Total|Total of all reporting groups
11034052|NCT01221623|FG000|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034053|NCT01221623|FG001|Participant Flow|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034054|NCT01221623|OG000|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034055|NCT01221623|OG001|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034056|NCT01221623|EG000|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034057|NCT01221623|EG001|Reported Event|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
11034058|NCT01221727|BG000|Baseline|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2. Out of 21 subjects enrolled and randomized, 19 subjects received investigation product.
11034059|NCT01221727|BG001|Baseline|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16. Out of 9 subjects enrolled and randomized, 8 subjects received investigation product.
11034060|NCT01221727|BG002|Baseline|Total|Total of all reporting groups
11034061|NCT01221727|FG000|Participant Flow|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2
11034062|NCT01221727|FG001|Participant Flow|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16.
11034063|NCT01221727|OG000|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
11034064|NCT01221727|OG000|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
11034065|NCT01221727|OG000|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16 , and 60 mg subcutaneous dose of Denosumab on day 2
11034066|NCT01221727|OG000|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
11034067|NCT01221727|EG000|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 1|
11034068|NCT01221727|EG001|Reported Event|Midazolam With Denosumab Group With Denosumab 60mg on Day 2-15|
11034069|NCT01221727|EG002|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 16|
11034070|NCT01221727|EG003|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 1|
11034071|NCT01221727|EG004|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 2-15|
11034072|NCT01221727|EG005|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 16|
11034073|NCT01221753|BG000|Baseline|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
11034074|NCT01221753|FG000|Participant Flow|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
11034075|NCT01221753|OG000|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
11034076|NCT01221753|EG000|Reported Event|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
11034077|NCT01221857|BG000|Baseline|NiCord|NiCord®: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.
11034078|NCT01221857|FG000|Participant Flow|NiCord|NiCord: NiCord is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.
11034079|NCT01221857|OG000|Outcome|NiCord|Analysis population is patients transplanted with NiCord plus unmanipulated cord blood unit.
11034080|NCT01221857|OG000|Outcome|Neutrophil Engraftment|Patients transplanted with NiCord plus unmanipulated cord blood unit.
11034081|NCT01221857|OG000|Outcome|Grade II-IV GvHD|All patients transplanted were assessed for acute GvHD grade II-IV.
11034082|NCT01221857|OG001|Outcome|Grade III-IV GvHD|All patients transplanted were assessed for acute GvHD grade III-IV.
11034083|NCT01221857|OG000|Outcome|Non-relapse Mortality|proportion of patients with non-relapse mortality at 100 days
11034084|NCT01221857|EG000|Reported Event|NiCord|NiCord®: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.
11034085|NCT01221948|BG000|Baseline|Deep Brain Stimulation|"Vercise (TM) Rechargeable Deep Brain Stimulation System~Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System"
11034086|NCT01221948|FG000|Participant Flow|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
11034087|NCT01221948|OG000|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
11034088|NCT01221948|EG000|Reported Event|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
11034089|NCT01222078|BG000|Baseline|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
11034090|NCT01222078|FG000|Participant Flow|Otelixizumab|Participant received a single dose of otelixizumab intravenous (IV) infusions each given over a 30 minute period on 8 consecutive days in order: 0.1 milligrams (mg), 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before start of infusion (SOI), 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
11034091|NCT01222078|OG000|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
11034092|NCT01222078|OG000|Outcome|Overall Study Arm|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
11034093|NCT01222078|EG000|Reported Event|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
11034094|NCT01222091|BG000|Baseline|All Study Participants|Half of the participants received propranolol at the first study session and the saline placebo at the second session. The treatment infusions were administered continuously before, during, and after remifentanil infusion.
11034095|NCT01222091|FG000|Participant Flow|Propranolol, Then Placebo|Half of the participants received propranolol at the first study session and the saline placebo at the second session. The treatment infusions were administered continuously before, during, and after remifentanil infusion.
11034096|NCT01222091|FG001|Participant Flow|Placebo, Then Propranolol|Half of the participants received saline placebo at the first study session and propranolol at the second session. The treatment infusions were administered continuously before, during, and after remifentanil infusion.
11034097|NCT01222091|OG000|Outcome|Propranolol|Half of the participants received propranolol at the first study session and the saline placebo at the second session. The treatment infusions were administered continuously before, during, and after remifentanil infusion.
11034098|NCT01222091|OG001|Outcome|Placebo|Half of the participants received propranolol at the first study session and the saline placebo at the second session. The treatment infusions were administered continuously before, during, and after remifentanil infusion.
11034099|NCT01222091|EG000|Reported Event|Propranolol|Half of the participants received propranolol at the first study session and the saline placebo at the second session. The treatment infusions were administered continuously before, during, and after remifentanil infusion.
11034100|NCT01222091|EG001|Reported Event|Placebo|Half of the participants received propranolol at the first study session and the saline placebo at the second session. The treatment infusions were administered continuously before, during, and after remifentanil infusion.
11034101|NCT01222104|BG000|Baseline|All Participants|
11034102|NCT01222104|FG000|Participant Flow|All Participants|
11034103|NCT01222104|OG000|Outcome|Angio -Seal|Angio-Seal attempted and/or deployed group
11034104|NCT01222104|OG000|Outcome|Angio-Seal|Secondary outcome reported in subjects with successful Angio-Seal deployment which achieved hemostasis by device.
11034105|NCT01222104|OG000|Outcome|All Participants|
11034106|NCT01222104|OG000|Outcome|All Participants|All enrolled participants
11034107|NCT01222104|OG000|Outcome|All Participants With Deployments and Readable Angiograms|
11034108|NCT01222104|OG000|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
11034109|NCT01222104|OG000|Outcome|Participants With Deployment|Participants with successful or attempted Angio-Seal deployments
11348883|NCT04140890|OG000|Outcome|Treatment|Participants in the treatment group will be asked to meet with an occupational therapist in their home weekly over 12 weeks. Each session takes an hour. In the first session, the occupational therapist will introduce the program. In session 2, the therapist will discuss pain and pain management with the participant. In session 3-12, the therapist will help the participant to develop physical activity and healthy eating habits. In each session the participant will pick two healthy behaviors to turn them into a habit. The therapist will give the participant a workbook and teach the participant to track his/her progress. The focus of session 3-5 will be physical activity, and session 6-11 will be healthy eating. In the last session (session 12), the therapist will wrap up the program and help the participant to develop a maintenance plan.
11348884|NCT04140890|OG001|Outcome|Control|Participants in the control group will receive newsletters focused on general healthy aging topics over 12 weeks. With the exception of two, 1-page handouts covering PA and dietary recommendations, the weekly content will not overlap with the treatment content. Within 4 days of mailing the newsletter, a trained research assistant (RA) will call the participant, verify receipt of the newsletter, and ask them if they have any questions about the materials. The phone call will last ~15 minutes. Control condition participants receive no further intervention.
11034110|NCT01222104|EG000|Reported Event|All Participants|
11034111|NCT01222117|BG000|Baseline|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
11348885|NCT04140890|OG000|Outcome|Treatment|Participants in the treatment group will be asked to meet with an occupational therapist in their home weekly over 12 weeks.
11034112|NCT01222117|BG001|Baseline|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034113|NCT01222117|BG002|Baseline|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034114|NCT01222117|BG003|Baseline|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034115|NCT01222117|BG004|Baseline|Plasminogen Activator Blinded Group E|"PA administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
11034116|NCT01222117|BG005|Baseline|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
11348886|NCT04140890|EG000|Reported Event|Control|Participants in the control group will receive newsletters focused on general healthy aging topics over 12 weeks. With the exception of two, 1-page handouts covering PA and dietary recommendations, the weekly content will not overlap with the treatment content. Within 4 days of mailing the newsletter, a trained research assistant (RA) will call the participant, verify receipt of the newsletter, and ask them if they have any questions about the materials. The phone call will last ~15 minutes. Control condition participants receive no further intervention.
11348887|NCT04140890|EG001|Reported Event|Treatment|Participants in the treatment group will be asked to meet with an occupational therapist in their home weekly over 12 weeks. Each session takes an hour. In the first session, the occupational therapist will introduce the program. In session 2, the therapist will discuss pain and pain management with the participant. In session 3-12, the therapist will help the participant to develop physical activity and healthy eating habits. In each session the participant will pick two healthy behaviors to turn them into a habit. The therapist will give the participant a workbook and teach the participant to track his/her progress. The focus of session 3-5 will be physical activity, and session 6-11 will be healthy eating. In the last session (session 12), the therapist will wrap up the program and help the participant to develop a maintenance plan.
11348888|NCT04139018|BG000|Baseline|Timolol Gel Arm|"Participants in the timolol gel arm (active medication arm) will receive timolol nasal gel 0.1% with 0.5 mL applied to each nostril twice daily via a syringe that will amount to a 2 mg total daily dose.~Timolol Gel: Timolol nasal gel 0.1% will be prepared with a poloxamer gel (combination of poloxamer 188 and 407; pH adjusted to 4.5-6.5) and 0.5 ml applied to each nostril twice daily. The total daily dose would amount to 2 mg."
11348889|NCT04139018|BG001|Baseline|Placebo Gel Arm|"Participants in the placebo gel arm will receive the gel itself with no active medication.~Placebo Gel: Placebo gel is prepared with poloxamers and no active ingredients."
11348890|NCT04139018|BG002|Baseline|Total|Total of all reporting groups
11348891|NCT04139018|FG000|Participant Flow|Timolol Gel Arm|"Participants in the timolol gel arm (active medication arm) will receive timolol nasal gel 0.1% with 0.5 mL applied to each nostril twice daily via a syringe that will amount to a 2 mg total daily dose.~Timolol Gel: Timolol nasal gel 0.1% will be prepared with a poloxamer gel (combination of poloxamer 188 and 407; pH adjusted to 4.5-6.5) and 0.5 ml applied to each nostril twice daily. The total daily dose would amount to 2 mg."
11348892|NCT04139018|FG001|Participant Flow|Placebo Gel Arm|"Participants in the placebo gel arm will receive the gel itself with no active medication.~Placebo Gel: Placebo gel is prepared with poloxamers and no active ingredients."
11348893|NCT04139018|OG000|Outcome|Timolol Gel Arm|"Participants in the timolol gel arm (active medication arm) will receive timolol nasal gel 0.1% with 0.5 mL applied to each nostril twice daily via a syringe that will amount to a 2 mg total daily dose.~Timolol Gel: Timolol nasal gel 0.1% will be prepared with a poloxamer gel (combination of poloxamer 188 and 407; pH adjusted to 4.5-6.5) and 0.5 ml applied to each nostril twice daily. The total daily dose would amount to 2 mg."
11034117|NCT01222117|BG006|Baseline|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034118|NCT01222117|BG007|Baseline|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11348894|NCT04139018|OG001|Outcome|Placebo Gel Arm|"Participants in the placebo gel arm will receive the gel itself with no active medication.~Placebo Gel: Placebo gel is prepared with poloxamers and no active ingredients."
11348895|NCT04139018|EG000|Reported Event|Timolol Gel Arm|"Participants in the timolol gel arm (active medication arm) will receive timolol nasal gel 0.1% with 0.5 mL applied to each nostril twice daily via a syringe that will amount to a 2 mg total daily dose.~Timolol Gel: Timolol nasal gel 0.1% will be prepared with a poloxamer gel (combination of poloxamer 188 and 407; pH adjusted to 4.5-6.5) and 0.5 ml applied to each nostril twice daily. The total daily dose would amount to 2 mg."
11348896|NCT04139018|EG001|Reported Event|Placebo Gel Arm|"Participants in the placebo gel arm will receive the gel itself with no active medication.~Placebo Gel: Placebo gel is prepared with poloxamers and no active ingredients."
11348897|NCT04138810|BG000|Baseline|Post-op VCE|"As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The VCE group will conduct their encounter via the videoconference section of the MyChart mobile applications. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.~VCE: Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.~Survey: Measure of satisfaction regarding post-op visit."
11348898|NCT04138810|BG001|Baseline|Office Post-operative Visits|"As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The traditional follow up group will receive a telephone call from the office nurse as is current standard of care. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.~Survey: Measure of satisfaction regarding post-op visit."
11348899|NCT04138810|BG002|Baseline|Total|Total of all reporting groups
11034119|NCT01222117|BG008|Baseline|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034120|NCT01222117|BG009|Baseline|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034121|NCT01222117|BG010|Baseline|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034122|NCT01222117|BG011|Baseline|Total|Total of all reporting groups
11034123|NCT01222117|FG000|Participant Flow|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034124|NCT01222117|FG001|Participant Flow|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034125|NCT01222117|FG002|Participant Flow|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034126|NCT01222117|FG003|Participant Flow|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
10887349|NCT00499915|FG001|Participant Flow|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
11034127|NCT01222117|FG004|Participant Flow|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
11034128|NCT01222117|FG005|Participant Flow|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
11034129|NCT01222117|FG006|Participant Flow|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034130|NCT01222117|FG007|Participant Flow|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034131|NCT01222117|FG008|Participant Flow|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034132|NCT01222117|FG009|Participant Flow|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034133|NCT01222117|FG010|Participant Flow|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034134|NCT01222117|OG000|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034135|NCT01222117|OG001|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034136|NCT01222117|OG002|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034137|NCT01222117|OG003|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034138|NCT01222117|OG004|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
11034139|NCT01222117|OG005|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
11034140|NCT01222117|OG006|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034141|NCT01222117|OG007|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034142|NCT01222117|OG008|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034143|NCT01222117|OG009|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034144|NCT01222117|OG010|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034145|NCT01222117|EG000|Reported Event|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034146|NCT01222117|EG001|Reported Event|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034147|NCT01222117|EG002|Reported Event|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034148|NCT01222117|EG003|Reported Event|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034149|NCT01222117|EG004|Reported Event|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
11034150|NCT01222117|EG005|Reported Event|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
11034151|NCT01222117|EG006|Reported Event|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034152|NCT01222117|EG007|Reported Event|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034153|NCT01222117|EG008|Reported Event|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034154|NCT01222117|EG009|Reported Event|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034155|NCT01222117|EG010|Reported Event|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
11034156|NCT01222195|BG000|Baseline|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
11034157|NCT01222195|FG000|Participant Flow|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
11034158|NCT01222195|OG000|Outcome|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
11034159|NCT01222195|EG000|Reported Event|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
11034160|NCT01222234|BG000|Baseline|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
11034161|NCT01222234|BG001|Baseline|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
11034162|NCT01222234|BG002|Baseline|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
11034163|NCT01222234|BG003|Baseline|Total|Total of all reporting groups
11034164|NCT01222234|FG000|Participant Flow|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
11034165|NCT01222234|FG001|Participant Flow|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
11034166|NCT01222234|FG002|Participant Flow|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
11034167|NCT01222234|OG000|Outcome|Group 1: Cholecalciferol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol 50,000 IU twice weekly for 8 weeks"
11034168|NCT01222234|OG001|Outcome|Group 2: Calcitriol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Calcitriol 0.25 mcg every day"
11034169|NCT01222234|OG000|Outcome|Group 1: CKD Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
11034170|NCT01222234|OG001|Outcome|Group 3: Non-CKD Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
11034171|NCT01222234|EG000|Reported Event|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
11034172|NCT01222234|EG001|Reported Event|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
11034173|NCT01222234|EG002|Reported Event|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
11225876|NCT02370602|OG003|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11034174|NCT01222260|BG000|Baseline|Treatment Arm|"Subjects with AL will receive Bendamustine and Dexamethasone~Bendamustine: Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle:~CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle~CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle~Available to qualifying subjects is the option to dose escalate to dose level (+)1:~120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study)~100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)~Dexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle"
11034175|NCT01222260|FG000|Participant Flow|Treatment Arm|"Subjects with relapsed/refractory systemic light-chain (AL) will receive Bendamustine and Dexamethasone.~Bendamustine: Patients will start bendamustine at dose level 0 and according to creatinine clearance (CrCl) on day 1 and 2 of each cycle:~CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle~CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle~Available to qualifying subjects is the option to dose escalate to dose level (+)1:~120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study)~100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)~Dexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle"
11034176|NCT01222260|OG000|Outcome|Treatment Arm|"Subjects with AL will receive Bendamustine and Dexamethasone~Bendamustine: Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle:~CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle~CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle~Available to qualifying subjects is the option to dose escalate to dose level (+)1:~120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study)~100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)~Dexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle"
11034177|NCT01222260|EG000|Reported Event|Treatment Arm|"Subjects with AL will receive Bendamustine and Dexamethasone~Bendamustine: Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle:~CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle~CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle~Available to qualifying subjects is the option to dose escalate to dose level (+)1:~120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study)~100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)~Dexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle"
11034178|NCT01222273|BG000|Baseline|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
11034179|NCT01222273|FG000|Participant Flow|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
11034180|NCT01222273|OG000|Outcome|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
11034181|NCT01222273|EG000|Reported Event|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
11034182|NCT01222286|BG000|Baseline|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
11034183|NCT01222286|BG001|Baseline|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
11034184|NCT01222286|BG002|Baseline|Total|Total of all reporting groups
11034185|NCT01222286|FG000|Participant Flow|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
11034186|NCT01222286|FG001|Participant Flow|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
11034187|NCT01222286|OG000|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
11034188|NCT01222286|OG001|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
11034189|NCT01222286|EG000|Reported Event|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
11034190|NCT01222286|EG001|Reported Event|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
11034191|NCT01222299|BG000|Baseline|Placebo|"placebo comparator nasal product~placebo comparator nasal product: sterile nasal product twice daily"
11034192|NCT01222299|BG001|Baseline|Low Dose - 2%|"bepotastine besilate nasal product - low dose~bepotastine besilate nasal product - low dose: sterile nasal product twice daily"
11034193|NCT01222299|BG002|Baseline|Medium Dose - 4%|"bepotastine besilate nasal product - medium dose~bepotastine besilate nasal product - medium dose: sterile nasal product twice daily"
11034194|NCT01222299|BG003|Baseline|High Dose - 6%|"bepotastine besilate nasal product - high dose~bepotastine besilate nasal product - high dose: sterile nasal product twice daily"
11034195|NCT01222299|BG004|Baseline|Total|Total of all reporting groups
11034196|NCT01222299|FG000|Participant Flow|Placebo|"placebo comparator nasal product~placebo comparator nasal product: sterile nasal product twice daily"
11034197|NCT01222299|FG001|Participant Flow|Low Dose - 2%|"bepotastine besilate nasal product - low dose~bepotastine besilate nasal product - low dose: sterile nasal product twice daily"
11034198|NCT01222299|FG002|Participant Flow|Medium Dose - 4%|"bepotastine besilate nasal product - medium dose~bepotastine besilate nasal product - medium dose: sterile nasal product twice daily"
11034199|NCT01222299|FG003|Participant Flow|High Dose - 6%|"bepotastine besilate nasal product - high dose~bepotastine besilate nasal product - high dose: sterile nasal product twice daily"
11034200|NCT01222299|OG000|Outcome|Placebo|"placebo comparator nasal product~placebo comparator nasal product: sterile nasal product twice daily"
11034201|NCT01222299|OG001|Outcome|Low Dose - 2%|"bepotastine besilate nasal product - low dose~bepotastine besilate nasal product - low dose: sterile nasal product twice daily"
11034202|NCT01222299|OG002|Outcome|Medium Dose - 4%|"bepotastine besilate nasal product - medium dose~bepotastine besilate nasal product - medium dose: sterile nasal product twice daily"
11034203|NCT01222299|OG003|Outcome|High Dose - 6%|"bepotastine besilate nasal product - high dose~bepotastine besilate nasal product - high dose: sterile nasal product twice daily"
11034204|NCT01222299|EG000|Reported Event|Placebo|"placebo comparator nasal product~placebo comparator nasal product: sterile nasal product twice daily"
11034205|NCT01222299|EG001|Reported Event|Low Dose - 2%|"bepotastine besilate nasal product - low dose~bepotastine besilate nasal product - low dose: sterile nasal product twice daily"
11034206|NCT01222299|EG002|Reported Event|Medium Dose - 4%|"bepotastine besilate nasal product - medium dose~bepotastine besilate nasal product - medium dose: sterile nasal product twice daily"
11034207|NCT01222299|EG003|Reported Event|High Dose - 6%|"bepotastine besilate nasal product - high dose~bepotastine besilate nasal product - high dose: sterile nasal product twice daily"
11034208|NCT01222390|BG000|Baseline|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
11034209|NCT01222390|FG000|Participant Flow|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
11034210|NCT01222390|OG000|Outcome|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
11034211|NCT01222390|EG000|Reported Event|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
11034212|NCT01222403|BG000|Baseline|Fluad_aTIV|Subjects aged >65 years received one dose of Fluad_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
11034213|NCT01222403|BG001|Baseline|Vantaflu_aTIV|Subjects aged >65 years received one dose of Vantaflu_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
11034214|NCT01222403|BG002|Baseline|Total|Total of all reporting groups
11034215|NCT01222403|FG000|Participant Flow|Fluad_aTIV|Subjects aged >65 years received one dose of Fluad_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
11034216|NCT01222403|FG001|Participant Flow|Vantaflu_aTIV|Subjects aged >65 years received one dose of Vantaflu_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
11034217|NCT01222403|OG000|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of Fluad_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
11034218|NCT01222403|OG001|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of Vantaflu_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
11034219|NCT01222403|EG000|Reported Event|Fluad_aTIV|Subjects aged >65 years received one dose of Fluad_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
11034220|NCT01222403|EG001|Reported Event|Vantaflu_aTIV|Subjects aged >65 years received one dose of Vantaflu_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
11034221|NCT01222416|BG000|Baseline|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
11034222|NCT01222416|BG001|Baseline|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
11034223|NCT01222416|BG002|Baseline|Total|Total of all reporting groups
11034224|NCT01222416|FG000|Participant Flow|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
11034225|NCT01222416|FG001|Participant Flow|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
11034226|NCT01222416|OG000|Outcome|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
11034227|NCT01222416|OG001|Outcome|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
11034228|NCT01222416|EG000|Reported Event|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
11034229|NCT01222416|EG001|Reported Event|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
11034230|NCT01222494|BG000|Baseline|Antipsychotic Treated Educational Control|"Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator.~Diet and Exercise Education: Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional."
11034231|NCT01222494|BG001|Baseline|Antipsychotic Treated Weekly Behavioral Weight Loss|"Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.~Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit."
11034232|NCT01222494|BG002|Baseline|Non-antipsychotic Treated Weekly Behavioral Weight Loss|"Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.~Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit."
11034233|NCT01222494|BG003|Baseline|Total|Total of all reporting groups
11034234|NCT01222494|FG000|Participant Flow|Antipsychotic Treated Educational Control|"Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator.~Diet and Exercise Education: Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional."
11034235|NCT01222494|FG001|Participant Flow|Antipsychotic Treated Weekly Behavioral Weight Loss|"Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.~Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit."
11034236|NCT01222494|FG002|Participant Flow|Non-antipsychotic Treated Weekly Behavioral Weight Loss|"Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.~Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit."
11034237|NCT01222494|OG000|Outcome|Antipsychotic Treated Educational Control|"Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator.~Diet and Exercise Education: Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional."
11034238|NCT01222494|OG001|Outcome|Antipsychotic Treated Weekly Behavioral Weight Loss|"Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.~Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit."
11034239|NCT01222494|OG002|Outcome|Non-antipsychotic Treated Weekly Behavioral Weight Loss|"Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.~Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit."
11034240|NCT01222494|EG000|Reported Event|Antipsychotic Treated Educational Control|"Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator.~Diet and Exercise Education: Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional."
11034241|NCT01222494|EG001|Reported Event|Antipsychotic Treated Weekly Behavioral Weight Loss|"Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.~Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit."
11034242|NCT01222494|EG002|Reported Event|Non-antipsychotic Treated Weekly Behavioral Weight Loss|"Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.~Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit."
11034243|NCT01222507|BG000|Baseline|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
11034244|NCT01222507|FG000|Participant Flow|Brain Speed Test (BST)|60 subjects who complete 60 Second Brain Game and Brain Speed Test
11034245|NCT01222507|OG000|Outcome|Brain Processing Speed|Brain Speed Test is measured through Brain Speed Test, and the results are transformed to z-scores based on normal population data.Z-score is calculated by subtracting the raw score (x) from the mean of the population (µ) which is then divided by the standard deviation of the population.
11034246|NCT01222507|EG000|Reported Event|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
11034247|NCT01222520|BG000|Baseline|Telmisartan and Amlodipine FDC|
11034248|NCT01222520|BG001|Baseline|Telmisartan|
11034249|NCT01222520|BG002|Baseline|Total|Total of all reporting groups
11034250|NCT01222520|FG000|Participant Flow|Telmisartan and Amlodipine FDC|
11034251|NCT01222520|FG001|Participant Flow|Telmisartan|
11034252|NCT01222520|OG000|Outcome|Telmisartan and Amlodipine FDC|
11034253|NCT01222520|OG001|Outcome|Telmisartan|
11034254|NCT01222520|EG000|Reported Event|Telmisartan and Amlodipine FDC|
11034255|NCT01222520|EG001|Reported Event|Telmisartan|
11034256|NCT01222533|BG000|Baseline|Study Overall|Total number of patients randomised and treated in the study.
11034257|NCT01222533|FG000|Participant Flow|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 5-period crossover trial. 154 patients were randomised to one of 15 sequences and treated. The trial was blinded within the 4 Respimat treatments, but open for the HandiHaler treatment. Each of the 5 treatment regimens was taken for 4 weeks without washouts between treatment periods.
11034258|NCT01222533|OG000|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
11034259|NCT01222533|OG001|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
11034260|NCT01222533|OG002|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
11034261|NCT01222533|OG003|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
11034262|NCT01222533|OG004|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
11034263|NCT01222533|EG000|Reported Event|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
11034264|NCT01222533|EG001|Reported Event|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
11034265|NCT01222533|EG002|Reported Event|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
11034266|NCT01222533|EG003|Reported Event|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
11034267|NCT01222533|EG004|Reported Event|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
11034268|NCT01222572|BG000|Baseline|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
11034269|NCT01222572|FG000|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
11225877|NCT02370602|OG004|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
11034270|NCT01222572|FG001|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 2)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 50 Gy; Stereotactic Boost to Primary: 15 Gy; Total Dose to Primary: 65 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
11034271|NCT01222572|FG002|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 3)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 46 Gy; Stereotactic Boost to Primary: 20 Gy; Total Dose to Primary: 66 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
11034272|NCT01222572|OG000|Outcome|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
11034273|NCT01222572|EG000|Reported Event|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
11034274|NCT01222585|BG000|Baseline|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
11034275|NCT01222585|FG000|Participant Flow|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
11034276|NCT01222585|OG000|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
11034277|NCT01222585|EG000|Reported Event|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
11034278|NCT01222689|BG000|Baseline|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib by mouth (PO) every day (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
11225878|NCT02370602|OG001|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11034279|NCT01222689|FG000|Participant Flow|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
11034280|NCT01222689|OG000|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
11034281|NCT01222689|EG000|Reported Event|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
11034282|NCT01222715|BG000|Baseline|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
11034283|NCT01222715|BG001|Baseline|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
11034284|NCT01222715|BG002|Baseline|Total|Total of all reporting groups
11225879|NCT02370602|OG000|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
11225880|NCT02370602|OG001|Outcome|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
11225881|NCT02370602|OG001|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11034285|NCT01222715|FG000|Participant Flow|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
11034286|NCT01222715|FG001|Participant Flow|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
11034287|NCT01222715|OG000|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
11034288|NCT01222715|OG001|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
11034289|NCT01222715|EG000|Reported Event|Regimen A|Vinorelbine/cyclophosphamide (VC) + bevacizumab
11034290|NCT01222715|EG001|Reported Event|Regimen B|Vinorelbine/cyclophosphamide (VC) + temsirolimus
11034291|NCT01222767|BG000|Baseline|PM00104|PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
11034292|NCT01222767|FG000|Participant Flow|PM00104|PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
11034293|NCT01222767|OG000|Outcome|PM00104|PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
11034294|NCT01222767|EG000|Reported Event|PM00104|PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
11034295|NCT01222832|BG000|Baseline|Bacitracin|"Nasopore sponge soaked in Bacitracin~Bacitracin: Bacitracin soaked sponge"
11034296|NCT01222832|BG001|Baseline|Saline|Nasopore sponge soaked in saline
11034297|NCT01222832|BG002|Baseline|Total|Total of all reporting groups
11034298|NCT01222832|FG000|Participant Flow|Bacitracin|"Nasopore sponge soaked in Bacitracin~Bacitracin: Bacitracin soaked sponge"
11034299|NCT01222832|FG001|Participant Flow|Saline|Saline soaked sponge and oral antibiotics
11034300|NCT01222832|OG000|Outcome|Bacitracin|Bacitracin soaked sponge
11034301|NCT01222832|OG001|Outcome|Saline|Saline soaked sponge and oral antibiotics
11034302|NCT01222832|EG000|Reported Event|Bacitracin|Bacitracin soaked sponge
11034303|NCT01222832|EG001|Reported Event|Saline|Saline soaked sponge and oral antibiotics
11034304|NCT01222884|BG000|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
11034305|NCT01222884|BG001|Baseline|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
11034306|NCT01222884|BG002|Baseline|Total|Total of all reporting groups
11034307|NCT01222884|FG000|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
11034308|NCT01222884|FG001|Participant Flow|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
11034309|NCT01222884|OG000|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
11034310|NCT01222884|OG001|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
11034311|NCT01222884|EG000|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
11225882|NCT02370602|OG002|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11034312|NCT01222884|EG001|Reported Event|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
11034313|NCT01223027|BG000|Baseline|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
11034314|NCT01223027|BG001|Baseline|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
11034315|NCT01223027|BG002|Baseline|Total|Total of all reporting groups
11034316|NCT01223027|FG000|Participant Flow|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
11034317|NCT01223027|FG001|Participant Flow|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
11034318|NCT01223027|OG000|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
11034319|NCT01223027|OG001|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
11034320|NCT01223027|EG000|Reported Event|Dovitinib|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
11034321|NCT01223027|EG001|Reported Event|Sorafenib|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
11034322|NCT01223183|BG000|Baseline|Isotonic Saline Then Hypertonic Saline|Subjects inhaled isotonic saline on study day 1, then had a washout period of 5-24 days, then inhaled 7% hypertonic saline on study day 2
11034323|NCT01223183|BG001|Baseline|Hypertonic Saline Then Isotonic Saline|Subjects inhaled 7% hypertonic saline on study day 1, then had a washout period of 5-24 days, then inhaled isotonic saline on study day 2
11034324|NCT01223183|BG002|Baseline|Total|Total of all reporting groups
11034325|NCT01223183|FG000|Participant Flow|Isotonic Saline Then Hypertonic Saline|Subjects inhale nebulized isotonic saline on study day 1, then perform a washout period of 5-24 days, then inhale 7% hypertonic saline on study day 2.
11034326|NCT01223183|FG001|Participant Flow|Hypertonic Saline Then Isotonic Saline|Subjects inhale nebulized 7% hypertonic saline on study day 1, then perform a 5-24 day washout period, and then inhale nebulized isotonic saline on study day 2.
11034327|NCT01223183|OG000|Outcome|Isotonic Saline Inhalation|Results from isotonic inhalation day
11034328|NCT01223183|OG000|Outcome|Hypertonic Saline Inhalation|Results from hypertonic saline inhalation day
11034329|NCT01223183|OG000|Outcome|Isotonic Saline Inhalation|Results from isotonic saline inhalation day
11034330|NCT01223183|EG000|Reported Event|Isotonic Saline Then Hypertonic Saline|Subjects inhaled isotonic saline on study day 1 and hypertonic saline on study day 2
11034331|NCT01223183|EG001|Reported Event|Hypertonic Saline Then Isotonic Saline|Subjects inhaled hypertonic saline on study day 1 and isotonic saline on study day 2
11034332|NCT01223196|BG000|Baseline|Placebo|One arm of the study subjects will be treated with Placebo only.
11034333|NCT01223196|BG001|Baseline|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
11034334|NCT01223196|BG002|Baseline|Total|Total of all reporting groups
11034335|NCT01223196|FG000|Participant Flow|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
11034336|NCT01223196|FG001|Participant Flow|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
11034337|NCT01223196|OG000|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
11034338|NCT01223196|OG001|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
11034339|NCT01223196|OG000|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
11034340|NCT01223196|OG001|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
11034341|NCT01223196|EG000|Reported Event|Placebo|One arm of the study subjects will be treated with Placebo only.
11034342|NCT01223196|EG001|Reported Event|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
11034343|NCT01223235|BG000|Baseline|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
11034344|NCT01223235|FG000|Participant Flow|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
11034345|NCT01223235|OG000|Outcome|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
11034346|NCT01223235|EG000|Reported Event|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
11034347|NCT01223352|BG000|Baseline|Bosentan 2 mg/kg t.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally three times a day (t.i.d.) for a planned duration of 24 weeks
11034348|NCT01223352|BG001|Baseline|Bosentan 2 mg/kg b.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally twice daily (b.i.d.) for a planned duration of 24 weeks
11034349|NCT01223352|BG002|Baseline|Total|Total of all reporting groups
11034350|NCT01223352|FG000|Participant Flow|Bosentan 2 mg/kg t.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally three times a day (t.i.d.) for a planned duration of 24 weeks
11034351|NCT01223352|FG001|Participant Flow|Bosentan 2 mg/kg b.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally twice daily (b.i.d.) for a planned duration of 24 weeks
11034352|NCT01223352|OG000|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
11034353|NCT01223352|OG001|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
11034354|NCT01223352|OG000|Outcome|Bosentan 2 mg/kg t.i.d.|Patients randomized to the bosentan 2 mg/kg t.i.d. group.
11034355|NCT01223352|OG001|Outcome|Bosentan 2 mg/kg b.i.d|Patients randomized to the bosentan 2 mg/kg b.i.d. group.
11034356|NCT01223352|OG000|Outcome|Bosentan 2 mg/kg t.i.d.|Patients randomized to the bosentan 2 mg/kg t.i.d. group
11034357|NCT01223352|OG001|Outcome|Bosentan 2 mg/kg b.i.d.|Patients randomized to the bosentan 2 mg/kg b.i.d. group
11034358|NCT01223352|OG000|Outcome|Bosentan 2 mg/kg t.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan.
11034359|NCT01223352|OG001|Outcome|Bosentan 2 mg/kg b.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan.
11034360|NCT01223352|EG000|Reported Event|Bosentan 2 mg/kg t.i.d|Patients received 2 mg/kg of bosentan 3 times a day (morning, afternoon, evening) for at least 0.4 week and up to 28.7 weeks
11034361|NCT01223352|EG001|Reported Event|Bosentan 2 mg/kg b.i.d|Patients received 2 mg/kg of bosentan twice daily (morning and evening) for at least 6 weeks and up to 26.4 weeks
11034362|NCT01223365|BG000|Baseline|Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at th3 successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
11034363|NCT01223365|FG000|Participant Flow|Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
11034364|NCT01223365|OG000|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
11034365|NCT01223365|OG001|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
11034366|NCT01223365|OG002|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
11034367|NCT01223365|OG003|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
11034368|NCT01223365|EG000|Reported Event|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
11034369|NCT01223365|EG001|Reported Event|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
11034370|NCT01223365|EG002|Reported Event|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
11034371|NCT01223378|BG000|Baseline|BOL-303259-X 0.006%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.006%, once daily (QD) 28 days"
11034372|NCT01223378|BG001|Baseline|BOL-303259-X 0.012%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.012%, once daily (QD) 28 days"
11034373|NCT01223378|BG002|Baseline|BOL-303259-X 0.024%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.024%, once daily (QD) 28 days"
11034374|NCT01223378|BG003|Baseline|BOL-303259-X 0.040%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.040%, once daily (QD) 28 days"
11034375|NCT01223378|BG004|Baseline|Latanoprost|"ophthalmic solution~Latanoprost: 0.005% ophthalmic solution, QD 28 days"
11034376|NCT01223378|BG005|Baseline|Total|Total of all reporting groups
11034377|NCT01223378|FG000|Participant Flow|BOL-303259-X 0.006%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.006%, once daily (QD) 28 days"
11034378|NCT01223378|FG001|Participant Flow|BOL-303259-X 0.012%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.012%, once daily (QD) 28 days"
11034379|NCT01223378|FG002|Participant Flow|BOL-303259-X 0.024%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.024%, once daily (QD) 28 days"
11034380|NCT01223378|FG003|Participant Flow|BOL-303259-X 0.040%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.040%, once daily (QD) 28 days"
11034381|NCT01223378|FG004|Participant Flow|Latanoprost|"ophthalmic solution~Latanoprost: 0.005% ophthalmic solution, QD 28 days"
11034382|NCT01223378|OG000|Outcome|BOL-303259-X 0.006%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.006%, once daily (QD) 28 days"
11034383|NCT01223378|OG001|Outcome|BOL-303259-X 0.012%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.012%, once daily (QD) 28 days"
11034384|NCT01223378|OG002|Outcome|BOL-303259-X 0.024%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.024%, once daily (QD) 28 days"
11034385|NCT01223378|OG003|Outcome|BOL-303259-X 0.040%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.040%, once daily (QD) 28 days"
11034386|NCT01223378|OG004|Outcome|Latanoprost|"ophthalmic solution~Latanoprost: 0.005% ophthalmic solution, QD 28 days"
11034387|NCT01223378|EG000|Reported Event|BOL-303259-X 0.006%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.006%, once daily (QD) 28 days"
11034388|NCT01223378|EG001|Reported Event|BOL-303259-X 0.012%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.012%, once daily (QD) 28 days"
11034389|NCT01223378|EG002|Reported Event|BOL-303259-X 0.024%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.024%, once daily (QD) 28 days"
11034390|NCT01223378|EG003|Reported Event|BOL-303259-X 0.040%|"ophthalmic solution~Experimental: BOL-303259-X: ophthalmic solution, 0.040%, once daily (QD) 28 days"
11034391|NCT01223378|EG004|Reported Event|Latanoprost|"ophthalmic solution~Latanoprost: 0.005% ophthalmic solution, QD 28 days"
11034392|NCT01223404|BG000|Baseline|All Study Participants|Participants in each of the six arms received all three interventions (placebo, nicotine, mecamylamine).
11034393|NCT01223404|FG000|Participant Flow|Placebo, Nicotine, Mecamylamine|First session: Placebo patch and placebo capsule (filler: methylcellulose) Second session: Nicotine patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Mecamylamine capsule
11034394|NCT01223404|FG001|Participant Flow|Nicotine, Placebo, Mecamylamine|First session: Nicotine patch and placebo capsule (filler: methylcellulose) Second session: Placebo patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Mecamylamine capsule
11034395|NCT01223404|FG002|Participant Flow|Placebo, Mecamylamine, Nicotine|First session: Placebo patch and Placebo capsule (filler: methylcellulose) Second session: Placebo patch and Mecamylamine capsule Third session: Nicotine patch and Placebo capsule (filler: methylcellulose)
11034396|NCT01223404|FG003|Participant Flow|Nicotine, Mecamylamine, Placebo|First session: Nicotine patch and placebo capsule (filler: methylcellulose) Second session: Placebo patch and Mecamylamine capsule Third session: Placebo patch and Placebo capsule (filler: methylcellulose)
11034397|NCT01223404|FG004|Participant Flow|Mecamylamine, Placebo, Nicotine|First session: Placebo patch and Mecamylamine capsule Second session: Placebo patch and Placebo capsule (filler: methylcellulose) Third session: Nicotine patch and Placebo capsule (filler: methylcellulose)
11034398|NCT01223404|FG005|Participant Flow|Mecamylamine, Nicotine, Placebo|First session: Placebo patch and Mecamylamine capsule Second session: Nicotine patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Placebo capsule (filler: methylcellulose)
11034399|NCT01223404|OG000|Outcome|Intervention: Placebo|A placebo patch and a placebo capsule are administered.
11034400|NCT01223404|OG001|Outcome|Intervention: Nicotine|A nicotine patch and a placebo capsule is administered.
11034401|NCT01223404|OG002|Outcome|Intervention: Mecamylamine|A placebo patch and a mecamylamine capsule are administered.
11034402|NCT01223404|OG001|Outcome|Intervention: Nicotine|A nicotine patch and a placebo capsule are administered.
11034403|NCT01223404|OG000|Outcome|Intervention: Placebo|A placebo patch and a placebo capsule is administered.
11034404|NCT01223404|OG002|Outcome|Intervention: Mecamylamine|A placebo patch and a mecamylamine capsule were administered.
11034405|NCT01223404|OG000|Outcome|Intervention: Placebo|A placebo patch and a placebo capsule were administered.
11034406|NCT01223404|OG001|Outcome|Intervention: Nicotine|A nicotine patch and a placebo capsule were administered.
11034407|NCT01223404|OG000|Outcome|Intervention: Placebo|Placebo patch and placebo capsule.
11034408|NCT01223404|OG001|Outcome|Intervention: Nicotine|Nicotine patch and placebo capsule.
11034409|NCT01223404|OG002|Outcome|Intervention: Mecamylamine|Placebo patch and mecamylamine capsule.
11034410|NCT01223404|EG000|Reported Event|Intervention: Placebo|Participants receive a placebo patch and a placebo capsule.
11034411|NCT01223404|EG001|Reported Event|Intervention: Nicotine|Participants receive a nicotine patch and a placebo capsule.
11034412|NCT01223404|EG002|Reported Event|Intervention: Mecamylamine|Participants receive a placebo patch and a mecamylamine capsule.
11034413|NCT01223469|BG000|Baseline|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
11034414|NCT01223469|BG001|Baseline|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
11034415|NCT01223469|BG002|Baseline|Total|Total of all reporting groups
11034416|NCT01223469|FG000|Participant Flow|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
11034417|NCT01223469|FG001|Participant Flow|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
11034418|NCT01223469|OG000|Outcome|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
11034419|NCT01223469|OG001|Outcome|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
11034420|NCT01223469|EG000|Reported Event|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
11034421|NCT01223469|EG001|Reported Event|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
11034422|NCT01223703|BG000|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
11034423|NCT01223703|BG001|Baseline|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
11034424|NCT01223703|BG002|Baseline|Total|Total of all reporting groups
11034425|NCT01223703|FG000|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
11034426|NCT01223703|FG001|Participant Flow|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
11034427|NCT01223703|OG000|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
11034428|NCT01223703|OG001|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
11034429|NCT01223703|EG000|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
11034430|NCT01223703|EG001|Reported Event|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
11034431|NCT01223937|BG000|Baseline|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
11034432|NCT01223937|BG001|Baseline|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
11034433|NCT01223937|BG002|Baseline|Total|Total of all reporting groups
11034434|NCT01223937|FG000|Participant Flow|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
11034435|NCT01223937|FG001|Participant Flow|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
11034436|NCT01223937|OG000|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
11034437|NCT01223937|OG001|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
11034438|NCT01223937|EG000|Reported Event|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
11034439|NCT01223937|EG001|Reported Event|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
11034440|NCT01223963|BG000|Baseline|Macrolane|Women that have had breast enhancement with Macrolane Volume Restoration Factor.
11034441|NCT01223963|FG000|Participant Flow|Macrolane|Women that have had breast enhancement with Macrolane Volume Restoration Factor.
11034442|NCT01223963|OG000|Outcome|Macrolane|Number of related Adverse events reported during the study period
11034443|NCT01223963|OG000|Outcome|Macrolane|Women that have had breast enhancement with Macrolane Volume Restoration Factor.
11034444|NCT01223963|EG000|Reported Event|Macrolane|Women that have had breast enhancement with Macrolane Volume Restoration Factor.
11034445|NCT01224015|BG000|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034446|NCT01224015|BG001|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034447|NCT01224015|BG002|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034448|NCT01224015|BG003|Baseline|Total|Total of all reporting groups
11034449|NCT01224015|FG000|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034450|NCT01224015|FG001|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034451|NCT01224015|FG002|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034452|NCT01224015|OG000|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034453|NCT01224015|OG001|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034454|NCT01224015|OG002|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034455|NCT01224015|EG000|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034456|NCT01224015|EG001|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034457|NCT01224015|EG002|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
11034458|NCT01224145|BG000|Baseline|Drug: Bupivacaine Collagen Sponge|"4, 5x5 bupivacaine collagen sponges~4, 5x5cm bupivacaine collagen sponges"
11034459|NCT01224145|FG000|Participant Flow|Drug: Bupivacaine Collagen Sponge|"4, 5x5 bupivacaine collagen sponges~4, 5x5cm bupivacaine collagen sponges"
11034460|NCT01224145|OG000|Outcome|Bupivacaine Collagen Sponge|Bupivacaine Collagen Sponge
11034461|NCT01224145|OG000|Outcome|Bupivacaine Collagen Sponge|4, 5x5 bupivacaine collagen sponges
11034462|NCT01224145|EG000|Reported Event|Drug: Bupivacaine Collagen Sponge|4, 5x5 bupivacaine collagen sponges
11034463|NCT01224158|BG000|Baseline|Manual Toothbrush (PR-000172)|Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
11034464|NCT01224158|BG001|Baseline|Power Toothbrush (PR-009577)|Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
11034465|NCT01224158|BG002|Baseline|Total|Total of all reporting groups
11034466|NCT01224158|FG000|Participant Flow|Manual Toothbrush (PR-000172)|Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
11034467|NCT01224158|FG001|Participant Flow|Power Toothbrush (PR-009577)|Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
11034468|NCT01224158|OG000|Outcome|Manual Toothbrush (PR-000172)|Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
11034469|NCT01224158|OG001|Outcome|Power Toothbrush (PR-009577)|Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
11034470|NCT01224158|EG000|Reported Event|Manual Toothbrush (PR-000172)|Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
11034471|NCT01224158|EG001|Reported Event|Power Toothbrush (PR-009577)|Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
11034472|NCT01224171|BG000|Baseline|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
11034473|NCT01224171|BG001|Baseline|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
11034474|NCT01224171|BG002|Baseline|Total|Total of all reporting groups
11034475|NCT01224171|FG000|Participant Flow|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
11034476|NCT01224171|FG001|Participant Flow|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
11034477|NCT01224171|OG000|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
11034478|NCT01224171|OG001|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
11034479|NCT01224171|EG000|Reported Event|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
11034480|NCT01224171|EG001|Reported Event|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
11034481|NCT01224210|BG000|Baseline|Ambrisentan (24 Weeks), Extension (4 Weeks)|Long-term extension of 24-28 weeks of ambrisentan.
11034482|NCT01224210|FG000|Participant Flow|Ambrisentan (24 Weeks), Extension (4 Weeks)|Treatment-naive Group 1 Pulmonary Arterial Hypertension patients with Porto-pulmonary Hypertension with Child-Pugh class A/B were administered with ambrisentan for 24 weeks, followed by a long-term extension (24-28 weeks).
11034483|NCT01224210|OG000|Outcome|Ambrisentan|"Open Label Ambrisentan~Ambrisentan: Ambrisentan once-daily in the morning with or without food. The adult dose selected for this study will be 5 mg for the first 4 weeks. After the initial 4 weeks the dose will be increased to 10mg (available doses are 5, and 10 mg) based on tolerance safety. Subjects will remain on 10mg until they complete the study. Dose adjustments may be made based on side effects."
11034484|NCT01224210|OG000|Outcome|Group 1 PAH With PoPH|Treatment-naive Group 1 PAH patients with PoPH with Child-Pugh class A/B were administered with ambrisentan for 24 weeks, followed by a long-term extension (24-28 weeks).
11034485|NCT01224210|EG000|Reported Event|Ambrisentan (24 Weeks), Extension (4 Weeks)|Treatment-naive Group 1 Pulmonary Arterial Hypertension patients with Porto-pulmonary Hypertension with Child-Pugh class A/B were administered with ambrisentan for 24 weeks, followed by a long-term extension (24-28 weeks).
11034486|NCT01224236|BG000|Baseline|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
11034487|NCT01224236|BG001|Baseline|Control|multivitamin solution without iron
11034488|NCT01224236|BG002|Baseline|Total|Total of all reporting groups
11034489|NCT01224236|FG000|Participant Flow|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
11034490|NCT01224236|FG001|Participant Flow|Control|multivitamin solution without iron
11034491|NCT01224236|OG000|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
11034492|NCT01224236|OG001|Outcome|Control|multivitamin solution without iron
11034493|NCT01224236|EG000|Reported Event|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
11034494|NCT01224236|EG001|Reported Event|Control|multivitamin solution without iron
11034495|NCT01224431|BG000|Baseline|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
11034496|NCT01224431|BG001|Baseline|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
11034497|NCT01224431|BG002|Baseline|Total|Total of all reporting groups
11034498|NCT01224431|FG000|Participant Flow|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
11034499|NCT01224431|FG001|Participant Flow|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
11034500|NCT01224431|OG000|Outcome|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
11034501|NCT01224431|OG001|Outcome|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
11034502|NCT01224431|OG000|Outcome|Buffered Lidocaine J-tip|Buffered Lidocaine group: Pain Scores and Cry Time Between Groups
11034503|NCT01224431|OG001|Outcome|Normal Saline J-tip|Normal Saline Group: Pain scores and cry time
11034504|NCT01224431|EG000|Reported Event|Buffered Lidacaine J-tip|Experimental: needleless injection of buffered lidocaine
11034505|NCT01224431|EG001|Reported Event|Normal Saline J-tip|Placebo Comparator: normal saline via needleless injection
11034506|NCT01224444|BG000|Baseline|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
11034507|NCT01224444|FG000|Participant Flow|All Adenomatous Polyps|Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≥5mm to ≤20mm.
11034508|NCT01224444|OG000|Outcome|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≥5mm and ≤20mm.
11034509|NCT01224444|EG000|Reported Event|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
11034510|NCT01224626|BG000|Baseline|Linezolid|Participants who have been treated with Zyvox (linezolid).
11034511|NCT01224626|FG000|Participant Flow|Linezolid|Participants who have been treated with Zyvox (linezolid).
11034512|NCT01224626|OG000|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
11034513|NCT01224626|EG000|Reported Event|Linezolid|Participants who have been treated with Zyvox (linezolid).
11034514|NCT01224639|BG000|Baseline|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
11034515|NCT01224639|BG001|Baseline|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11034516|NCT01224639|BG002|Baseline|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
11034517|NCT01224639|BG003|Baseline|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
11034518|NCT01224639|BG004|Baseline|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
11034519|NCT01224639|BG005|Baseline|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11034520|NCT01224639|BG006|Baseline|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
11034521|NCT01224639|BG007|Baseline|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
11034522|NCT01224639|BG008|Baseline|Total|Total of all reporting groups
11034523|NCT01224639|FG000|Participant Flow|Low Dose Subcutaneous: TDV|TDV 0.5 milliliter (mL), injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). Takeda's Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 plaque forming units (PFU), TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
11034524|NCT01224639|FG001|Participant Flow|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11034525|NCT01224639|FG002|Participant Flow|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
11034526|NCT01224639|FG003|Participant Flow|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
11034527|NCT01224639|FG004|Participant Flow|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
11034528|NCT01224639|FG005|Participant Flow|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11034529|NCT01224639|FG006|Participant Flow|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
11034530|NCT01224639|FG007|Participant Flow|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
11034531|NCT01224639|OG000|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
11034532|NCT01224639|OG001|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11034533|NCT01224639|OG002|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
11034534|NCT01224639|OG003|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
11034535|NCT01224639|OG004|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
11034536|NCT01224639|OG005|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11034537|NCT01224639|OG006|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
11034538|NCT01224639|OG007|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
11034539|NCT01224639|EG000|Reported Event|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
11034540|NCT01224639|EG001|Reported Event|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11034541|NCT01224639|EG002|Reported Event|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
11034542|NCT01224639|EG003|Reported Event|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
11034543|NCT01224639|EG004|Reported Event|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
11034544|NCT01224639|EG005|Reported Event|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11034545|NCT01224639|EG006|Reported Event|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
11034546|NCT01224639|EG007|Reported Event|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
11034547|NCT01224678|BG000|Baseline|Placebo|Patients receive oral placebo once daily for 12 months.
11034548|NCT01224678|BG001|Baseline|Vitamin D|Patients receive oral vitamin D (2000 IU) once daily for 12 months.
11034549|NCT01224678|BG002|Baseline|Total|Total of all reporting groups
11034550|NCT01224678|FG000|Participant Flow|Placebo|Patients receive oral placebo once daily for 12 months.
11034551|NCT01224678|FG001|Participant Flow|Vitamin D|Patients receive oral vitamin D (2000 IU) once daily for 12 months.
11034552|NCT01224678|OG000|Outcome|Placebo|Patients receive oral placebo once daily for 12 months.
11034553|NCT01224678|OG001|Outcome|Vitamin D|Patients receive oral vitamin D (2000 IU) once daily for 12 months.
11034554|NCT01224678|EG000|Reported Event|Placebo|Patients receive oral placebo once daily for 12 months.
11034555|NCT01224678|EG001|Reported Event|Vitamin D|Patients receive oral vitamin D (2000 IU) once daily for 12 months.
11034556|NCT01224782|BG000|Baseline|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
11034557|NCT01224782|FG000|Participant Flow|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
11034558|NCT01224782|OG000|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
11034559|NCT01224782|EG000|Reported Event|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
11034560|NCT01224821|BG000|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
11034561|NCT01224821|FG000|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
11034562|NCT01224821|OG000|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
11034563|NCT01224821|EG000|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
11034564|NCT01224925|BG000|Baseline|Dycal - Calcium Hydroxide Material|"Pulp capping with Dycal~Direct pulp capping over carious exposure: Dycal: covered with Fuji IX. After one week,part of the temporary filling was left under the permanent filling"
11034565|NCT01224925|BG001|Baseline|WMTA - White Mineral Trioxide Aggregate|"Pulp capping with Mineral Trioxide Aggregate~Direct pulp capping: WMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic"
11034566|NCT01224925|BG002|Baseline|Total|Total of all reporting groups
11034567|NCT01224925|FG000|Participant Flow|Dycal - Calcium Hydroxide Material|"Pulp capping with Dycal~Direct pulp capping over carious exposure: Dycal: covered with Fuji IX. After one week,part of the temporary filling was left under the permanent filling"
11034568|NCT01224925|FG001|Participant Flow|WMTA - White Mineral Trioxide Aggregate|"Pulp capping with Mineral Trioxide Aggregate~Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX. After one week, the entire temporary filling was removed the cavity was permanently restored with a composite resin material used at the study clinic"
11034569|NCT01224925|OG000|Outcome|Dycal - Calcium Hydroxide Material|"Pulp capping with Dycal~direct pulp capping over carious exposure: Dycal: covered with Fuji IX"
11034570|NCT01224925|OG001|Outcome|WMTA - White Mineral Trioxide Aggregate|"Pulp capping with Mineral Trioxide Aggregate~Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX"
11034571|NCT01224925|OG000|Outcome|Direct Pulp Capping With Dycal|"Total caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany)~Direct pulp capping over carious exposure with Dycal: Direct pulp capping over carious exposure with Dycal.~Dycal: covered with Fuji IX"
11034572|NCT01224925|OG001|Outcome|Direct Pulp Capping With WMTA|"Total caries removal. In case of pulp exposure Direct Pulp capping with Mineral Trioxide Aggregate White ProRoot® (WMTA) (DENTSPLY, Tulsa Dental, Tulsa, OK, USA)~Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX"
11034573|NCT01224925|EG000|Reported Event|Capping Over Carious Exposure With Dycal|Direct pulp capping over carious exposure: Dycal: covered with Fuji IX
11034574|NCT01224925|EG001|Reported Event|Capping Over Carious Exposure With WMTA|Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX
11034575|NCT01225029|BG000|Baseline|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
11034576|NCT01225029|BG001|Baseline|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
11034577|NCT01225029|BG002|Baseline|Total|Total of all reporting groups
11034578|NCT01225029|FG000|Participant Flow|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
11034579|NCT01225029|FG001|Participant Flow|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
11034580|NCT01225029|OG000|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
11034581|NCT01225029|OG001|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
11034582|NCT01225029|EG000|Reported Event|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
11034583|NCT01225029|EG001|Reported Event|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
11034584|NCT01225055|BG000|Baseline|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
11034585|NCT01225055|BG001|Baseline|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
11034586|NCT01225055|BG002|Baseline|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
11034587|NCT01225055|BG003|Baseline|Total|Total of all reporting groups
11034588|NCT01225055|FG000|Participant Flow|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
11034589|NCT01225055|FG001|Participant Flow|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
11034590|NCT01225055|FG002|Participant Flow|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
11034591|NCT01225055|OG000|Outcome|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
11034592|NCT01225055|OG001|Outcome|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
11034593|NCT01225055|OG002|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
11034594|NCT01225055|EG000|Reported Event|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
11034595|NCT01225055|EG001|Reported Event|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
11034596|NCT01225055|EG002|Reported Event|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
11034597|NCT01225068|BG000|Baseline|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
11034598|NCT01225068|BG001|Baseline|Placebo|Placebo treatment group
11034599|NCT01225068|BG002|Baseline|Total|Total of all reporting groups
11034600|NCT01225068|FG000|Participant Flow|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
11034601|NCT01225068|FG001|Participant Flow|Placebo|Placebo treatment group
11034602|NCT01225068|OG000|Outcome|Placebo|Placebo arm
11034603|NCT01225068|OG001|Outcome|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
11034604|NCT01225068|EG000|Reported Event|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
11034605|NCT01225068|EG001|Reported Event|Placebo|Placebo treatment group
11034606|NCT01225146|BG000|Baseline|Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
11034607|NCT01225146|BG001|Baseline|Cohort 2|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
11034608|NCT01225146|BG002|Baseline|Total|Total of all reporting groups
11034609|NCT01225146|FG000|Participant Flow|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
11034610|NCT01225146|FG001|Participant Flow|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
11034611|NCT01225146|OG000|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
11034612|NCT01225146|OG001|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
11034613|NCT01225146|OG000|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria."
11034614|NCT01225146|OG001|Outcome|Treatment Naive (Cohort 2)|Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
11034615|NCT01225146|EG000|Reported Event|Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
11034616|NCT01225146|EG001|Reported Event|Cohort 2|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
11034617|NCT01225159|BG000|Baseline|Tight Glycaemic Control (TGC)|TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
11225883|NCT02370602|OG003|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
11034618|NCT01225159|BG001|Baseline|Conventional Glycaemic Control (Control)|Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
11034619|NCT01225159|BG002|Baseline|Total|Total of all reporting groups
11034620|NCT01225159|FG000|Participant Flow|Tight Glycaemic Control (TGC)|"Allocated to intensive group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
11034621|NCT01225159|FG001|Participant Flow|Conventional Glycaemic Control (Control)|"Allocated to control group (n = 100)~• Received allocated intervention (n = 100)"
11034622|NCT01225159|OG000|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
11034623|NCT01225159|OG001|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
11034624|NCT01225159|EG000|Reported Event|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
11034625|NCT01225159|EG001|Reported Event|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
11034626|NCT01225172|BG000|Baseline|BMS 100+LET|Treatment with 100 mg BMS-754807 + 2.5 mg letrozole
11034627|NCT01225172|BG001|Baseline|BMS 100|100 mg BMS-754807 alone
11034628|NCT01225172|BG002|Baseline|Total|Total of all reporting groups
11034629|NCT01225172|FG000|Participant Flow|BMS 100+LET|Treatment with 100 mg BMS-754807 + 2.5 mg letrozole
11034630|NCT01225172|FG001|Participant Flow|BMS 100|100 mg BMS-754807 alone
11034631|NCT01225172|OG000|Outcome|BMS 100 + LET|Treatment with 100 mg BMS-754807 + 2.5 mg letrozole
11034632|NCT01225172|OG001|Outcome|BMS 100|100 mg BMS-754807 alone
11225884|NCT02370602|OG004|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
11034633|NCT01225172|EG000|Reported Event|BMS 100+LET|Treatment with 100 mg BMS-754807 + 2.5 mg letrozole
11034634|NCT01225172|EG001|Reported Event|BMS 100|100 mg BMS-754807 alone
11034635|NCT01225211|BG000|Baseline|Cohort 1: Placebo|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
11034636|NCT01225211|BG001|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
11034637|NCT01225211|BG002|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
11034638|NCT01225211|BG003|Baseline|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
11034639|NCT01225211|BG004|Baseline|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034640|NCT01225211|BG005|Baseline|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034641|NCT01225211|BG006|Baseline|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034642|NCT01225211|BG007|Baseline|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034643|NCT01225211|BG008|Baseline|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
11034644|NCT01225211|BG009|Baseline|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
11034645|NCT01225211|BG010|Baseline|Total|Total of all reporting groups
11034646|NCT01225211|FG000|Participant Flow|Cohort 1: Placebo|Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
11034647|NCT01225211|FG001|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
11034648|NCT01225211|FG002|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
11034649|NCT01225211|FG003|Participant Flow|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
11034650|NCT01225211|FG004|Participant Flow|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034651|NCT01225211|FG005|Participant Flow|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034652|NCT01225211|FG006|Participant Flow|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034653|NCT01225211|FG007|Participant Flow|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034654|NCT01225211|FG008|Participant Flow|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
11034655|NCT01225211|FG009|Participant Flow|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
11034656|NCT01225211|OG000|Outcome|Cohort 1: Placebo - Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
11034657|NCT01225211|OG001|Outcome|Cohort 1: LUM 200 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
11034658|NCT01225211|OG002|Outcome|Cohort 1: Placebo - Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
11034659|NCT01225211|OG003|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
11034660|NCT01225211|OG004|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
11034661|NCT01225211|OG000|Outcome|Cohort 2 and 3: Placebo (HO and HE) - Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
11225885|NCT02370602|OG005|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
11034662|NCT01225211|OG001|Outcome|Cohort 2: LUM 200 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
11034663|NCT01225211|OG002|Outcome|Cohort 2: LUM 400 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
11034664|NCT01225211|OG003|Outcome|Cohort 2: LUM 600 mg qd - Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
11034665|NCT01225211|OG004|Outcome|Cohort 3: LUM 400 mg q12h - Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
11034666|NCT01225211|OG005|Outcome|Cohort 2 and 3: Placebo (HO and HE) - Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
11034667|NCT01225211|OG006|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034668|NCT01225211|OG007|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034669|NCT01225211|OG008|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034670|NCT01225211|OG009|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034671|NCT01225211|OG000|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
11034672|NCT01225211|OG001|Outcome|Cohort 4: Active Study Drug|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
11034673|NCT01225211|OG000|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
11034674|NCT01225211|OG001|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
11034675|NCT01225211|OG000|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034676|NCT01225211|OG001|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034677|NCT01225211|OG002|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11225886|NCT02370602|EG000|Reported Event|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
11034678|NCT01225211|OG003|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) - Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034679|NCT01225211|OG004|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034680|NCT01225211|OG001|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
11034681|NCT01225211|OG000|Outcome|Cohort 1: LUM 200 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
11034682|NCT01225211|OG001|Outcome|Cohort 1: Placebo - Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
11034683|NCT01225211|OG000|Outcome|Cohort 2: LUM 200 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
11034684|NCT01225211|OG001|Outcome|Cohort 2: LUM 400 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
11034685|NCT01225211|OG002|Outcome|Cohort 2: LUM 600 mg qd (HO) - Period 1|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
11034686|NCT01225211|OG003|Outcome|Cohort 2: LUM 600 mg qd (HE) - Period 1|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
11034687|NCT01225211|OG005|Outcome|Cohort 2 and 3: Placebo (HO and HE) - Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
11034688|NCT01225211|OG000|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11225887|NCT02370602|EG001|Reported Event|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
11225888|NCT02370615|BG000|Baseline|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
11225889|NCT02370615|BG001|Baseline|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once on Day 3 to 8.
11034689|NCT01225211|OG001|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034690|NCT01225211|OG002|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034691|NCT01225211|OG003|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034692|NCT01225211|OG004|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034693|NCT01225211|OG005|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
11034694|NCT01225211|EG000|Reported Event|Cohort 1: LUM 200 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
11034695|NCT01225211|EG001|Reported Event|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
11034696|NCT01225211|EG002|Reported Event|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
11034697|NCT01225211|EG003|Reported Event|Cohort 1: Placebo - Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
11034698|NCT01225211|EG004|Reported Event|Cohort 1: Placebo - Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
11034699|NCT01225211|EG005|Reported Event|Cohort 2: LUM 200 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
11034700|NCT01225211|EG006|Reported Event|Cohort 2: LUM 400 mg qd - Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
11034701|NCT01225211|EG007|Reported Event|Cohort 2: LUM 600 mg qd - Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
11034702|NCT01225211|EG008|Reported Event|Cohort 3: LUM 400 mg q12h - Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
11034703|NCT01225211|EG009|Reported Event|Cohort 2 and 3: Placebo (HO and HE) - Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
11034704|NCT01225211|EG010|Reported Event|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034705|NCT01225211|EG011|Reported Event|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034706|NCT01225211|EG012|Reported Event|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034707|NCT01225211|EG013|Reported Event|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
11034708|NCT01225211|EG014|Reported Event|Cohort 2 and 3: Placebo (HO and HE) - Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
11034709|NCT01225211|EG015|Reported Event|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
11034710|NCT01225211|EG016|Reported Event|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
11034711|NCT01225250|BG000|Baseline|Polydioxanone (PDS) Plates|"15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft~Polydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.~Caudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure."
11034712|NCT01225250|BG001|Baseline|Non-plated Cartilagenous Graft|"15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft~Caudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure."
11225890|NCT02370615|BG002|Baseline|Total|Total of all reporting groups
11034713|NCT01225250|BG002|Baseline|Total|Total of all reporting groups
11034714|NCT01225250|FG000|Participant Flow|Polydioxanone (PDS) Plates|"15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft~Polydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.~Caudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure."
11034715|NCT01225250|FG001|Participant Flow|Non-plated Cartilagenous Graft|"15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft~Caudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure."
11034716|NCT01225250|OG000|Outcome|Polydioxanone (PDS) Plates|"15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft~Polydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.~Caudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure."
11034717|NCT01225250|OG001|Outcome|Non-plated Cartilagenous Graft|"15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft~Caudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure."
11034718|NCT01225250|EG000|Reported Event|Polydioxanone (PDS) Plates|"15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft~Polydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.~Caudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure."
11034719|NCT01225250|EG001|Reported Event|Non-plated Cartilagenous Graft|"15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft~Caudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure."
11034720|NCT01225263|BG000|Baseline|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
11034721|NCT01225263|BG001|Baseline|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
11034722|NCT01225263|BG002|Baseline|Total|Total of all reporting groups
11034723|NCT01225263|FG000|Participant Flow|Simvastatin and Vitamin D|Participants in this arm took Simvastatin 20 mg twice daily for 6 months plus Vitamin D3 1000 IU twice daily for 6 months.
11034724|NCT01225263|FG001|Participant Flow|"Placebo Sugar Pill"|Participants in this arm took placebo pills, which looked like the Simvastatin and Vitamin D. Two placebo pills were taken twice daily for 6 months.
11034725|NCT01225263|OG000|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
11034726|NCT01225263|OG001|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
11034727|NCT01225263|OG001|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
11034728|NCT01225263|EG000|Reported Event|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
11034729|NCT01225263|EG001|Reported Event|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
11034730|NCT01225289|BG000|Baseline|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
11034731|NCT01225289|BG001|Baseline|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
11034732|NCT01225289|BG002|Baseline|Total|Total of all reporting groups
11034733|NCT01225289|FG000|Participant Flow|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
11034734|NCT01225289|FG001|Participant Flow|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
11034735|NCT01225289|OG000|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
11034736|NCT01225289|OG001|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
11034737|NCT01225289|EG000|Reported Event|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
11034738|NCT01225289|EG001|Reported Event|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
11034739|NCT01225354|BG000|Baseline|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
11034740|NCT01225354|FG000|Participant Flow|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
11034741|NCT01225354|OG000|Outcome|Calcium Hydroxylapatite|"Subject will be treated at baseline and, if needed, at 2 weeks.~Calcium hydroxylapatite: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks."
11034742|NCT01225354|OG000|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
11034743|NCT01225354|EG000|Reported Event|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
11034744|NCT01225549|BG000|Baseline|Baseline Total|Total number of patients randomised and treated in the study
11034745|NCT01225549|FG000|Participant Flow|ACBP|AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo
11034746|NCT01225549|FG001|Participant Flow|APBC|AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid
11034747|NCT01225549|FG002|Participant Flow|BACP|AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo
11034748|NCT01225549|FG003|Participant Flow|BPCA|AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg
11034749|NCT01225549|FG004|Participant Flow|CAPB|Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od
11034750|NCT01225549|FG005|Participant Flow|CBAP|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo
11034751|NCT01225549|FG006|Participant Flow|CBPA|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg
11034752|NCT01225549|FG007|Participant Flow|PBAC|Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid
11034753|NCT01225549|FG008|Participant Flow|PCAB|Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od
11034754|NCT01225549|FG009|Participant Flow|PCBA|Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg
11034755|NCT01225549|OG000|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
10849044|NCT00293384|EG000|Reported Event|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
11034756|NCT01225549|OG001|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
11034757|NCT01225549|OG002|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
11034758|NCT01225549|OG003|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
11034759|NCT01225549|EG000|Reported Event|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
11034760|NCT01225549|EG001|Reported Event|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
11034761|NCT01225549|EG002|Reported Event|Arm 3 - 2x200ug Budesonide|2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
11034762|NCT01225549|EG003|Reported Event|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
11034763|NCT01225562|BG000|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
11034764|NCT01225562|BG001|Baseline|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
11034765|NCT01225562|BG002|Baseline|Placebo|Matching placebo
11034766|NCT01225562|BG003|Baseline|Total|Total of all reporting groups
11034767|NCT01225562|FG000|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
11034768|NCT01225562|FG001|Participant Flow|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
11034769|NCT01225562|FG002|Participant Flow|Placebo|Matching placebo
11034770|NCT01225562|OG000|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
11034771|NCT01225562|OG001|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
11034772|NCT01225562|OG002|Outcome|Placebo|Matching placebo
11034773|NCT01225562|EG000|Reported Event|Placebo|
11034774|NCT01225562|EG001|Reported Event|Ticagrelor 60mg bd|
11034775|NCT01225562|EG002|Reported Event|Ticagrelor 90mg bd|
11034776|NCT01225731|BG000|Baseline|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
11034777|NCT01225731|BG001|Baseline|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
11034778|NCT01225731|BG002|Baseline|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
11034779|NCT01225731|BG003|Baseline|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
11034780|NCT01225731|BG004|Baseline|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
11034781|NCT01225731|BG005|Baseline|Total|Total of all reporting groups
11034782|NCT01225731|FG000|Participant Flow|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
11034783|NCT01225731|FG001|Participant Flow|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
11034784|NCT01225731|FG002|Participant Flow|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
11034785|NCT01225731|FG003|Participant Flow|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
11034786|NCT01225731|FG004|Participant Flow|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
11034787|NCT01225731|FG005|Participant Flow|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
11034788|NCT01225731|FG006|Participant Flow|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
11034789|NCT01225731|FG007|Participant Flow|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
11034790|NCT01225731|FG008|Participant Flow|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
11034791|NCT01225731|FG009|Participant Flow|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
11034792|NCT01225731|FG010|Participant Flow|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
11034793|NCT01225731|FG011|Participant Flow|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
11034794|NCT01225731|FG012|Participant Flow|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
11034795|NCT01225731|OG000|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
11034796|NCT01225731|OG001|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
11034797|NCT01225731|OG002|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
11034798|NCT01225731|OG003|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
11034799|NCT01225731|OG004|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
11034800|NCT01225731|OG005|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
11034801|NCT01225731|OG006|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
11034802|NCT01225731|OG007|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
11034803|NCT01225731|OG008|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
11034804|NCT01225731|OG009|Outcome|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
11034805|NCT01225731|OG010|Outcome|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
11034806|NCT01225731|OG011|Outcome|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
11034807|NCT01225731|OG012|Outcome|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
11034808|NCT01225731|EG000|Reported Event|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
11034809|NCT01225731|EG001|Reported Event|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
11034810|NCT01225731|EG002|Reported Event|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
11034811|NCT01225731|EG003|Reported Event|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
11034812|NCT01225731|EG004|Reported Event|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
11034813|NCT01225731|EG005|Reported Event|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
11034814|NCT01225731|EG006|Reported Event|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
11034815|NCT01225731|EG007|Reported Event|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
11034816|NCT01225731|EG008|Reported Event|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
11034817|NCT01225731|EG009|Reported Event|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
11034818|NCT01225731|EG010|Reported Event|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
11034819|NCT01225731|EG011|Reported Event|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
11034820|NCT01225731|EG012|Reported Event|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
11034821|NCT01225731|EG013|Reported Event|Placebo Follow-up|Participants who received placebo in Part 1 and did not receive additional therapy.
11034822|NCT01225822|BG000|Baseline|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
11034823|NCT01225822|BG001|Baseline|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
11034824|NCT01225822|BG002|Baseline|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
11034825|NCT01225822|BG003|Baseline|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
11034826|NCT01225822|BG004|Baseline|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
11034827|NCT01225822|BG005|Baseline|Total|Total of all reporting groups
11034828|NCT01225822|FG000|Participant Flow|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid(twice daily) oral
11034829|NCT01225822|FG001|Participant Flow|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid(twice daily) oral
11034830|NCT01225822|FG002|Participant Flow|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid(twice daily) oral
11034831|NCT01225822|FG003|Participant Flow|BIBR 1048 300 mg qd|Dabigatran 300 mg qd(once daily) oral
11034832|NCT01225822|FG004|Participant Flow|Enoxaparin 40 mg qd|Enoxaparin 40 qd (once daily) subcutaneous injection
11034833|NCT01225822|OG000|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
11034834|NCT01225822|OG001|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
11034835|NCT01225822|OG002|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
11034836|NCT01225822|OG003|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
11034837|NCT01225822|OG004|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
11034838|NCT01225822|OG004|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mgqd (once daily) subcutaneous injection
11034839|NCT01225822|OG004|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40mg qd (once daily) subcutaneous injection
11034840|NCT01225822|OG001|Outcome|BIBR 1048 150 mg Bid|Dabigatran 50 mg bid (twice daily) oral
11034841|NCT01225822|EG000|Reported Event|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
11034842|NCT01225822|EG001|Reported Event|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
11034843|NCT01225822|EG002|Reported Event|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
11034844|NCT01225822|EG003|Reported Event|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
11034845|NCT01225822|EG004|Reported Event|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
11034846|NCT01225835|BG000|Baseline|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034847|NCT01225835|BG001|Baseline|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034848|NCT01225835|BG002|Baseline|Total|Total of all reporting groups
11034849|NCT01225835|FG000|Participant Flow|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034850|NCT01225835|FG001|Participant Flow|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034851|NCT01225835|OG000|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034852|NCT01225835|OG001|Outcome|Menotrophin: Stratum Age <39 Yrs|The subset of participants in the menotrophin treatment arm who were < 39 years old.
11034853|NCT01225835|OG002|Outcome|Menotrophin: Stratum Age >=39 Yrs|The subset of participants in the menotrophin treatment arm who were >= 39 years old.
11034854|NCT01225835|OG003|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034855|NCT01225835|OG004|Outcome|Follitrophin Alpha: Stratum Age <39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were < 39 years old.
11034856|NCT01225835|OG005|Outcome|Follitrophin Alpha: Stratum Age >=39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were >= 39 years old.
11034857|NCT01225835|OG000|Outcome|All Participants|The analysis of whether progesterone level is a predictor for ongoing pregnancy used all participants.
11034858|NCT01225835|OG001|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034859|NCT01225835|EG000|Reported Event|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034860|NCT01225835|EG001|Reported Event|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
11034861|NCT01225887|BG000|Baseline|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
11034862|NCT01225887|FG000|Participant Flow|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
11034863|NCT01225887|OG000|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
11034864|NCT01225887|EG000|Reported Event|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
11034865|NCT01225926|BG000|Baseline|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
11034866|NCT01225926|BG001|Baseline|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
11034867|NCT01225926|BG002|Baseline|Total|Total of all reporting groups
11034868|NCT01225926|FG000|Participant Flow|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
11034869|NCT01225926|FG001|Participant Flow|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
11034870|NCT01225926|OG000|Outcome|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
11034871|NCT01225926|OG001|Outcome|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
11034872|NCT01225926|EG000|Reported Event|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
11034873|NCT01225926|EG001|Reported Event|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
11034874|NCT01225952|BG000|Baseline|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
11034875|NCT01225952|BG001|Baseline|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
11034876|NCT01225952|BG002|Baseline|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
11034877|NCT01225952|BG003|Baseline|Total|Total of all reporting groups
11034878|NCT01225952|FG000|Participant Flow|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
11034879|NCT01225952|FG001|Participant Flow|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
11034880|NCT01225952|FG002|Participant Flow|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
11034881|NCT01225952|OG000|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
11034882|NCT01225952|OG001|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
11034883|NCT01225952|OG002|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
11034884|NCT01225952|EG000|Reported Event|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
11034885|NCT01225952|EG001|Reported Event|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
11034886|NCT01225952|EG002|Reported Event|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
11034887|NCT01225991|BG000|Baseline|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
11034888|NCT01225991|FG000|Participant Flow|Milnacipran, Active Drug, Open-label|"All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day, or to their maximum tolerated dose in the course of the first week. The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.~Milnacipran: All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day"
11034889|NCT01225991|OG000|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
11034890|NCT01225991|EG000|Reported Event|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
11034891|NCT01226043|BG000|Baseline|Crossover Phase: Pen / Vial & Syringe|Patients randomized to the sequence: Lantus SoloSTAR pen in Period 1 and Lantus vial and syringe in Period 2 for the 4-week crossover phase.
11034892|NCT01226043|BG001|Baseline|Crossover Phase: Vial & Syringe / Pen|Patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2 for the 4-week crossover phase.
11034893|NCT01226043|BG002|Baseline|Total|Total of all reporting groups
11034894|NCT01226043|FG000|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Lantus SoloSTAR® pen in Period 1 and Lantus vial and syringe in Period 2.
11034895|NCT01226043|FG001|Participant Flow|Vial &Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2.
11034896|NCT01226043|FG002|Participant Flow|SoloSTAR® Pen|Re-randomization phase and the observational phase: patients randomized to Lantus SoloSTAR® pen.
11034897|NCT01226043|FG003|Participant Flow|Vial and Syringe|Re-randomization phase and the observational phase: patients randomized to Lantus Vial and Syringe.
11034898|NCT01226043|OG000|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
11034899|NCT01226043|OG001|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
11034900|NCT01226043|OG000|Outcome|SoloSTAR® Pen|SoloSTAR® Pen used during the crossover phase either at period 1 or at period 2
11034901|NCT01226043|OG001|Outcome|Vial and Syringe|Vial and Syringe used during the crossover phase either at period 1 or at period 2
11034902|NCT01226043|OG000|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
11034903|NCT01226043|OG001|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
11034904|NCT01226043|OG000|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
11034905|NCT01226043|OG001|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
11034906|NCT01226043|OG000|Outcome|SoloSTAR® Pen (Period 1)|Patients using SoloSTAR® pen during period 1 of the crossover phase.
11034907|NCT01226043|OG001|Outcome|Vial and Syringe (Period 2)|Patients using Vial and Syringe during period 2 of the crossover phase.
11034908|NCT01226043|OG002|Outcome|SoloSTAR® Pen (Period 2)|Patients using SoloSTAR® pen during period 2 of the crossover phase.
11034909|NCT01226043|OG003|Outcome|Vial and Syringe (Period 1)|Patients using Vial and Syringe during period 1 of the crossover phase.
11034910|NCT01226043|OG000|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the re-randomization phase.
11034911|NCT01226043|OG001|Outcome|Vial and Syringe|Patients using Vial and Syringe during the re-randomization phase.
11034912|NCT01226043|OG000|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the observational phase.
11034913|NCT01226043|OG001|Outcome|Vial and Syringe|Patients using Vial and Syringe during the observational phase.
11034914|NCT01226043|OG000|Outcome|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
11034915|NCT01226043|OG001|Outcome|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
11034916|NCT01226043|OG002|Outcome|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
11034917|NCT01226043|OG003|Outcome|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
11034918|NCT01226043|OG004|Outcome|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
11034919|NCT01226043|OG005|Outcome|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
11034920|NCT01226043|EG000|Reported Event|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
11034921|NCT01226043|EG001|Reported Event|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
11034922|NCT01226043|EG002|Reported Event|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
11034923|NCT01226043|EG003|Reported Event|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
11034924|NCT01226043|EG004|Reported Event|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
11034925|NCT01226043|EG005|Reported Event|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
11066449|NCT01392378|EG008|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
11066450|NCT01392378|EG009|Reported Event|13vPnC + INFANRIX Hexa - After Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.
11066451|NCT01392378|EG010|Reported Event|13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
11066452|NCT01392378|EG011|Reported Event|13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
11066453|NCT01392378|EG012|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
11066454|NCT01392378|EG013|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
11066455|NCT01392378|EG014|Reported Event|13vPnC + INFANRIX Hexa - Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
11066456|NCT01392443|BG000|Baseline|Ruxolitinib|Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count >200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
11066457|NCT01392443|FG000|Participant Flow|Ruxolitinib|Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count >200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
11066458|NCT01392443|OG000|Outcome|Ruxolitinib|Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count >200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
11066459|NCT01392443|EG000|Reported Event|Ruxolitinib|Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count >200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
11066460|NCT01392469|BG000|Baseline|Imatinib+ Bosentan+ Sildenafil|Participants received treatment with bosentan 125 mg twice daily and sildenafil thrice daily for 8 days in treatment period 1. Participants were on the same sildenafil dose level (20, 40, 50 or 60 mg) they had been at study entry which was well tolerated in conjunction with bosentan. Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2. Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.
11149059|NCT01868477|BG001|Baseline|Deferasirox + Erythropoietin Alpha|Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study
11149060|NCT01868477|BG002|Baseline|Total|Total of all reporting groups
11034926|NCT01226095|BG000|Baseline|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
11034927|NCT01226095|FG000|Participant Flow|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
11034928|NCT01226095|OG000|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
11034929|NCT01226095|OG001|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
11034930|NCT01226095|OG000|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
11034931|NCT01226095|OG002|Outcome|Brufen Retard (All Visits)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information throughout this post-marketing observational study.
11034932|NCT01226095|OG001|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
11034933|NCT01226095|OG002|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
11034934|NCT01226095|OG000|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
11034935|NCT01226095|OG000|Outcome|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
11034936|NCT01226095|EG000|Reported Event|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
11034937|NCT01226121|BG000|Baseline|Day 1 Manipulation|Finger manipulation one day following collagenase injection
11034938|NCT01226121|BG001|Baseline|Day 2 Manipulation|Finger manipulation two days following collagenase injection
11034939|NCT01226121|BG002|Baseline|Day 4 Manipulation|Finger manipulation four days following collagenase injection
11034940|NCT01226121|BG003|Baseline|Total|Total of all reporting groups
11034941|NCT01226121|FG000|Participant Flow|Day 1 Manipulation|Finger manipulation one day following collagenase injection
11034942|NCT01226121|FG001|Participant Flow|Day 2 Manipulation|Finger manipulation two days following collagenase injection
11034943|NCT01226121|FG002|Participant Flow|Day 4 Manipulation|Finger manipulation four days following collagenase injection
11034944|NCT01226121|OG000|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
11034945|NCT01226121|OG001|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
11034946|NCT01226121|OG002|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
11034947|NCT01226121|EG000|Reported Event|Day 1 Manipulation|Finger manipulation one day following collagenase injection
11034948|NCT01226121|EG001|Reported Event|Day 2 Manipulation|Finger manipulation two days following collagenase injection
11034949|NCT01226121|EG002|Reported Event|Day 4 Manipulation|Finger manipulation four days following collagenase injection
11034950|NCT01226420|BG000|Baseline|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
11034951|NCT01226420|FG000|Participant Flow|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
11034952|NCT01226420|OG000|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
11034953|NCT01226420|EG000|Reported Event|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
11034954|NCT01226459|BG000|Baseline|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
11034955|NCT01226459|BG001|Baseline|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
11034956|NCT01226459|BG002|Baseline|Total|Total of all reporting groups
11034957|NCT01226459|FG000|Participant Flow|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
11034958|NCT01226459|FG001|Participant Flow|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
11034959|NCT01226459|OG000|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
11034960|NCT01226459|OG001|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
11034961|NCT01226459|EG000|Reported Event|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
11225891|NCT02370615|FG000|Participant Flow|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
11225892|NCT02370615|FG001|Participant Flow|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
11225893|NCT02370615|OG000|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
11225894|NCT02370615|OG001|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
11225895|NCT02370615|OG000|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
11034962|NCT01226459|EG001|Reported Event|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
11034963|NCT01226472|BG000|Baseline|KW-0761|KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
11034964|NCT01226472|FG000|Participant Flow|KW-0761|KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
11034965|NCT01226472|OG000|Outcome|KW-0761|KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
11034966|NCT01226472|EG000|Reported Event|KW-0761|KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
11034967|NCT01226485|BG000|Baseline|Part A: Cohort 1|Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.
11034968|NCT01226485|BG001|Baseline|Part A: Cohort 2|Part A Cohort 2 : 100 mg taladegib administered orally QD on a 28-day cycle.
11034969|NCT01226485|BG002|Baseline|Part A: Cohort 3|Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.
11034970|NCT01226485|BG003|Baseline|Part A: Cohort 4|Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.
11225896|NCT02370615|OG001|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
11225897|NCT02370615|OG000|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
11034971|NCT01226485|BG004|Baseline|Part A: Cohort 5|Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.
11034972|NCT01226485|BG005|Baseline|Part C|Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.
11034973|NCT01226485|BG006|Baseline|Part D|Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
11034974|NCT01226485|BG007|Baseline|Total|Total of all reporting groups
11034975|NCT01226485|FG000|Participant Flow|Part A: Cohort 1|Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.
11034976|NCT01226485|FG001|Participant Flow|Part A: Cohort 2|Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.
11034977|NCT01226485|FG002|Participant Flow|Part A: Cohort 3|Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.
11034978|NCT01226485|FG003|Participant Flow|Part A: Cohort 4|Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.
11034979|NCT01226485|FG004|Participant Flow|Part A: Cohort 5|Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.
11034980|NCT01226485|FG005|Participant Flow|Part C|Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.
11034981|NCT01226485|FG006|Participant Flow|Part D|Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
11034982|NCT01226485|OG000|Outcome|All Part A Participants|"Part A: Cohort 1 Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.~Part A: Cohort 2 Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.~Part A: Cohort 3 Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.~Part A: Cohort 4 Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.~Part A: Cohort 5 Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle."
11225898|NCT02370615|OG001|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
11225899|NCT02370615|OG000|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
11225900|NCT02370615|OG001|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
11225901|NCT02370615|OG000|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
11225902|NCT02370615|EG000|Reported Event|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
11225903|NCT02370615|EG001|Reported Event|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
11034983|NCT01226485|OG000|Outcome|50 mg Taladegib|50 milligram (mg) taladegib administered orally QD on a 28-day cycle.
11034984|NCT01226485|OG001|Outcome|100 mg Taladegib|100 mg taladegib administered orally QD on a 28-day cycle.
11034985|NCT01226485|OG002|Outcome|200 mg Taladegib|200 mg taladegib administered orally QD on a 28-day cycle.
11034986|NCT01226485|OG003|Outcome|400 mg Taladegib|400 mg taladegib administered orally QD on a 28-day cycle.
11034987|NCT01226485|OG004|Outcome|600 mg Taladegib|600 mg taladegib administered orally QD on a 28-day cycle.
11034988|NCT01226485|OG000|Outcome|Part A: Cohort 1|Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.
11034989|NCT01226485|OG001|Outcome|Part A: Cohort 2|Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.
11034990|NCT01226485|OG002|Outcome|Part A: Cohort 3|Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.
11034991|NCT01226485|OG003|Outcome|Part A: Cohort 4|Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.
11034992|NCT01226485|OG004|Outcome|Part A: Cohort 5|Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.
11034993|NCT01226485|OG005|Outcome|Part C|Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.
11034994|NCT01226485|OG006|Outcome|Part D|Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
11034995|NCT01226485|OG000|Outcome|Part C|Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.
11034996|NCT01226485|OG001|Outcome|Part D|Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
11034997|NCT01226485|EG000|Reported Event|Part A: Cohort 1|Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.
11034998|NCT01226485|EG001|Reported Event|Part A: Cohort 2|Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.
11034999|NCT01226485|EG002|Reported Event|Part A: Cohort 3|Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.
11035000|NCT01226485|EG003|Reported Event|Part A: Cohort 4|Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.
11035001|NCT01226485|EG004|Reported Event|Part A: Cohort 5|Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.
11035002|NCT01226485|EG005|Reported Event|Part C|Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.
11035003|NCT01226485|EG006|Reported Event|Part D|Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
11035004|NCT01226511|BG000|Baseline|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
11035005|NCT01226511|BG001|Baseline|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
11035006|NCT01226511|BG002|Baseline|Total|Total of all reporting groups
11035007|NCT01226511|FG000|Participant Flow|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
11035008|NCT01226511|FG001|Participant Flow|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
11035009|NCT01226511|OG000|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
11035010|NCT01226511|OG001|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
11035011|NCT01226511|OG000|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
11035012|NCT01226511|OG001|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
11035013|NCT01226511|EG000|Reported Event|Duloxetine|Adverse events (AEs) during the acute treatment period for participants who received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks.
11035014|NCT01226511|EG001|Reported Event|Placebo|AEs during the acute treatment period for participants who received placebo capsules orally, QD for 10 weeks.
11035015|NCT01226511|EG002|Reported Event|Duloxetine/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received flexible doses of duloxetine 30 to 120 mg orally, QD during both the acute and extension treatment periods (up to 28 weeks).
11035016|NCT01226511|EG003|Reported Event|Placebo/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received placebo capsules orally, QD during the acute treatment period (10 weeks) and flexible doses of duloxetine 30 to 120 mg orally, QD during the extension treatment period (up to 18 weeks).
11035017|NCT01226511|EG004|Reported Event|Duloxetine-Taper|AEs during the taper period for participants who were dispensed duloxetine prior to entering the taper phase. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period.
11035018|NCT01226511|EG005|Reported Event|Placebo-Taper|AEs during the taper period for participants who were dispensed placebo prior to entering the taper phase. Participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
11035019|NCT01226706|BG000|Baseline|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
11035020|NCT01226706|BG001|Baseline|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
11035021|NCT01226706|BG002|Baseline|Total|Total of all reporting groups
11035022|NCT01226706|FG000|Participant Flow|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
11035023|NCT01226706|FG001|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
11035024|NCT01226706|OG000|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
11035025|NCT01226706|OG001|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
11035026|NCT01226706|OG000|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
11035027|NCT01226706|OG001|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
11035028|NCT01226706|EG000|Reported Event|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
11035029|NCT01226706|EG001|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
11035030|NCT01226719|BG000|Baseline|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
11035031|NCT01226719|FG000|Participant Flow|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
11035032|NCT01226719|OG000|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
11035033|NCT01226719|EG000|Reported Event|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
11035034|NCT01226745|BG000|Baseline|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035035|NCT01226745|BG001|Baseline|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
11035036|NCT01226745|BG002|Baseline|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
11035037|NCT01226745|BG003|Baseline|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035038|NCT01226745|BG004|Baseline|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
11035039|NCT01226745|BG005|Baseline|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
11035040|NCT01226745|BG006|Baseline|Total|Total of all reporting groups
11035041|NCT01226745|FG000|Participant Flow|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035042|NCT01226745|FG001|Participant Flow|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
11035043|NCT01226745|FG002|Participant Flow|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
11035044|NCT01226745|FG003|Participant Flow|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035045|NCT01226745|FG004|Participant Flow|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
11035046|NCT01226745|FG005|Participant Flow|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
11035047|NCT01226745|OG000|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035048|NCT01226745|OG001|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
11035049|NCT01226745|OG002|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
11035050|NCT01226745|OG003|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035051|NCT01226745|OG004|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
11035052|NCT01226745|OG005|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
11035053|NCT01226745|OG000|Outcome|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035054|NCT01226745|EG000|Reported Event|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035055|NCT01226745|EG001|Reported Event|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
11035056|NCT01226745|EG002|Reported Event|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
11035057|NCT01226745|EG003|Reported Event|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
11035058|NCT01226745|EG004|Reported Event|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
11035059|NCT01226745|EG005|Reported Event|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
11035060|NCT01226914|BG000|Baseline|EVICEL Group|For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.
11035061|NCT01226914|BG001|Baseline|Placebo Group|For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.
11035062|NCT01226914|BG002|Baseline|Total|Total of all reporting groups
11035063|NCT01226914|FG000|Participant Flow|EVICEL Group|
11035064|NCT01226914|FG001|Participant Flow|Placebo Group|
11035065|NCT01226914|OG000|Outcome|EVICEL Group|For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.
11035066|NCT01226914|OG001|Outcome|Placebo Group|For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.
11035067|NCT01226914|EG000|Reported Event|EVICEL|For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.
11035068|NCT01226914|EG001|Reported Event|Placebo|For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.
11225904|NCT02370641|BG000|Baseline|Urolithin Excretors|"The excretor status was determined by analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.~PomX: 1000 mg POMx daily for 4 weeks"
11225905|NCT02370641|BG001|Baseline|Non Excretors|"The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.~PomX: 1000 mg POMx daily for 4 weeks"
11035069|NCT01226979|BG000|Baseline|HDRBT|"Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.~High-dose endorectal brachytherapy: The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer."
11035070|NCT01226979|FG000|Participant Flow|High-dose Endorectal Brachytherapy (HDRBT)|"The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.~Daily dose of 6.5 Gy over four consecutive days"
11035071|NCT01226979|OG000|Outcome|HDRBT (High Dose Rectal Brachytherapy)|"Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days~High-dose endorectal brachytherapy (HDRBT): The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer."
11035072|NCT01226979|OG000|Outcome|HDRBT|"The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.~Daily dose of 6.5 Gy over four consecutive days"
11035073|NCT01226979|EG000|Reported Event|High-Dose-Rate Endorectal Brachytherapy (HDRBT)|"The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.~Daily dose of 6.5 Gy over four consecutive days"
11035074|NCT01227005|BG000|Baseline|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
11035075|NCT01227005|BG001|Baseline|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
11035076|NCT01227005|BG002|Baseline|Total|Total of all reporting groups
11035077|NCT01227005|FG000|Participant Flow|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
11035078|NCT01227005|FG001|Participant Flow|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
11035079|NCT01227005|OG000|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
11035080|NCT01227005|OG001|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
11035081|NCT01227005|EG000|Reported Event|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
11035082|NCT01227005|EG001|Reported Event|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
11035083|NCT01227018|BG000|Baseline|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
11035084|NCT01227018|FG000|Participant Flow|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
11035085|NCT01227018|OG000|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
11035086|NCT01227018|EG000|Reported Event|STA-9090|175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression.
11035087|NCT01227044|BG000|Baseline|Placebo + MM/MC|"Placebo plus Medical Management/Medication Coaching~Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching"
11225906|NCT02370641|BG002|Baseline|Total|Total of all reporting groups
11035088|NCT01227044|BG001|Baseline|NTX + MM/MC|"Naltrexone + Medical Management/Medication Coaching~Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals."
11035089|NCT01227044|BG002|Baseline|Total|Total of all reporting groups
11035090|NCT01227044|FG000|Participant Flow|NTX + MM/MC|"Naltrexone + Medical Management/Medication Coaching~Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals."
11035091|NCT01227044|FG001|Participant Flow|Placebo + MM/MC|"Placebo plus Medical Management/Medication Coaching~Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching"
11035092|NCT01227044|OG000|Outcome|Placebo + MM/MC|"Placebo plus Medical Management/Medication Coaching~Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching"
11225907|NCT02370641|FG000|Participant Flow|Urolithin Excretors|"The excretor status was determined by analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.~PomX: 1000 mg POMx daily for 4 weeks"
11035093|NCT01227044|OG001|Outcome|NTX + MM/MC|"Naltrexone + Medical Management/Medication Coaching~Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals."
11035094|NCT01227044|EG000|Reported Event|Placebo + MM/MC|"Placebo plus Medical Management/Medication Coaching~Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching"
11035095|NCT01227044|EG001|Reported Event|NTX + MM/MC|"Naltrexone + Medical Management/Medication Coaching~Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals."
11035096|NCT01227057|BG000|Baseline|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
11035097|NCT01227057|BG001|Baseline|Arm 2: Case Management|Case Management: Case management
11035098|NCT01227057|BG002|Baseline|Total|Total of all reporting groups
11035099|NCT01227057|FG000|Participant Flow|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
11035100|NCT01227057|FG001|Participant Flow|Arm 2: Case Management|Case Management: Case management
11035101|NCT01227057|OG000|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
11035102|NCT01227057|OG001|Outcome|Arm 2: Case Management|Case Management: Case management
11035103|NCT01227057|OG001|Outcome|Arm 2: Case Management|"Case management~Case Management: Case management"
11035104|NCT01227057|EG000|Reported Event|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
11035105|NCT01227057|EG001|Reported Event|Arm 2: Case Management|Case Management: Case management
11035106|NCT01227252|BG000|Baseline|Placebo|Placebo was administered orally as capsules, once daily for 14 days.
11035107|NCT01227252|BG001|Baseline|5 mg LY2886721|A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035108|NCT01227252|BG002|Baseline|15 mg LY2886721|A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035109|NCT01227252|BG003|Baseline|35 mg LY2886721|A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035110|NCT01227252|BG004|Baseline|Total|Total of all reporting groups
11035111|NCT01227252|FG000|Participant Flow|Placebo|Placebo was administered orally as capsules, once daily for 14 days.
11035112|NCT01227252|FG001|Participant Flow|5 mg LY2886721|A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035113|NCT01227252|FG002|Participant Flow|15 mg LY2886721|A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035114|NCT01227252|FG003|Participant Flow|35 mg LY2886721|A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035115|NCT01227252|OG000|Outcome|Placebo|Placebo was administered orally as capsules, once daily for 14 days.
11035116|NCT01227252|OG001|Outcome|5 mg LY2886721|A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035117|NCT01227252|OG002|Outcome|15 mg LY2886721|A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035118|NCT01227252|OG003|Outcome|35 mg LY2886721|A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035119|NCT01227252|OG000|Outcome|5 mg LY2886721|Participants received a 5-mg oral dose of LY2886721 capsules, once daily for 14 days.
11035120|NCT01227252|OG001|Outcome|15 mg LY2886721|Participants received a 10-mg oral dose of LY2886721 capsules, once daily for 14 days.
11035121|NCT01227252|OG002|Outcome|35 mg LY2886721|Participants received a 35-mg oral dose of LY2886721 capsules, once daily for 14 days.
11035122|NCT01227252|EG000|Reported Event|Placebo|Placebo was administered orally as capsules, once daily for 14 days.
11035123|NCT01227252|EG001|Reported Event|5 mg LY2886721|A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035124|NCT01227252|EG002|Reported Event|15 mg LY2886721|A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035125|NCT01227252|EG003|Reported Event|35 mg LY2886721|A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
11035126|NCT01227265|BG000|Baseline|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
11035127|NCT01227265|BG001|Baseline|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
11035128|NCT01227265|BG002|Baseline|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
11035129|NCT01227265|BG003|Baseline|Total|Total of all reporting groups
11035130|NCT01227265|FG000|Participant Flow|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
11035131|NCT01227265|FG001|Participant Flow|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
11035132|NCT01227265|FG002|Participant Flow|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
11035133|NCT01227265|OG000|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
11035134|NCT01227265|OG001|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
11035135|NCT01227265|OG002|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
11035136|NCT01227265|EG000|Reported Event|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
11035137|NCT01227265|EG001|Reported Event|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
11035138|NCT01227265|EG002|Reported Event|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
11035139|NCT01227278|BG000|Baseline|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
11035140|NCT01227278|BG001|Baseline|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
11035141|NCT01227278|BG002|Baseline|Total|Total of all reporting groups
11035142|NCT01227278|FG000|Participant Flow|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
11035143|NCT01227278|FG001|Participant Flow|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
11035144|NCT01227278|OG000|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
11035145|NCT01227278|OG001|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
11035146|NCT01227278|EG000|Reported Event|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
11035147|NCT01227278|EG001|Reported Event|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
11035148|NCT01227382|BG000|Baseline|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
11035149|NCT01227382|FG000|Participant Flow|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
11035150|NCT01227382|OG000|Outcome|Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
11035151|NCT01227382|OG000|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
11035152|NCT01227382|OG000|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
11035153|NCT01227382|EG000|Reported Event|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
11035154|NCT01227395|BG000|Baseline|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035155|NCT01227395|BG001|Baseline|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
11035156|NCT01227395|BG002|Baseline|Total|Total of all reporting groups
11035157|NCT01227395|FG000|Participant Flow|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035158|NCT01227395|FG001|Participant Flow|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
11035159|NCT01227395|OG000|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035160|NCT01227395|OG001|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
11035161|NCT01227395|OG000|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035162|NCT01227395|OG001|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035163|NCT01227395|OG000|Outcome|Male|Male Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035164|NCT01227395|OG001|Outcome|Female|Female Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035165|NCT01227395|OG000|Outcome|Azithromycin With Concomitant Drugs|Participants with concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035166|NCT01227395|OG001|Outcome|Azithromycin Without Concomitant Drugs|Participants without concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035167|NCT01227395|OG000|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035168|NCT01227395|OG001|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035169|NCT01227395|OG000|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035170|NCT01227395|OG001|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035171|NCT01227395|OG000|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
11035172|NCT01227395|OG001|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
11035173|NCT01227395|OG000|Outcome|Male|Male Participants taking Azithromycin for Treatment according to Japanese Package Insert.
11035174|NCT01227395|OG001|Outcome|Female|Female Participants taking Azithromycin for Treatment according to Japanese Package Insert.
11035175|NCT01227395|OG000|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
11035176|NCT01227395|OG001|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
11035177|NCT01227395|OG000|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
11035178|NCT01227395|OG001|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
11035179|NCT01227395|OG000|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
11035180|NCT01227395|EG000|Reported Event|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
11035181|NCT01227395|EG001|Reported Event|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
11035182|NCT01227421|BG000|Baseline|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
11035183|NCT01227421|BG001|Baseline|Placebo|placebo tablet twice daily with food for 5 days
11035184|NCT01227421|BG002|Baseline|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
11035185|NCT01227421|BG003|Baseline|Total|Total of all reporting groups
11035186|NCT01227421|FG000|Participant Flow|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
11035187|NCT01227421|FG001|Participant Flow|Placebo|placebo tablet twice daily with food for 5 days
11035188|NCT01227421|FG002|Participant Flow|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
11035189|NCT01227421|OG000|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
11035190|NCT01227421|OG001|Outcome|Placebo|placebo tablet twice daily with food for 5 days
11035191|NCT01227421|OG002|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
11035192|NCT01227421|EG000|Reported Event|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
11035193|NCT01227421|EG001|Reported Event|Placebo|placebo tablet twice daily with food for 5 days
11035194|NCT01227421|EG002|Reported Event|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
11035195|NCT01227434|BG000|Baseline|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035196|NCT01227434|BG001|Baseline|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035197|NCT01227434|BG002|Baseline|Total|Total of all reporting groups
11035198|NCT01227434|FG000|Participant Flow|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, surgical resection for progression, and resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035199|NCT01227434|FG001|Participant Flow|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035200|NCT01227434|OG000|Outcome|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035201|NCT01227434|OG001|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035202|NCT01227434|OG000|Outcome|Surgical Group|PD 0332991 at a dose of 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035203|NCT01227434|EG000|Reported Event|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035204|NCT01227434|EG001|Reported Event|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
11035205|NCT01227512|BG000|Baseline|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
11035206|NCT01227512|BG001|Baseline|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
11035207|NCT01227512|BG002|Baseline|Total|Total of all reporting groups
11035208|NCT01227512|FG000|Participant Flow|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
11035209|NCT01227512|FG001|Participant Flow|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
11035210|NCT01227512|OG000|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
11035211|NCT01227512|OG001|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
11225908|NCT02370641|FG001|Participant Flow|Non Excretors|"The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.~PomX: 1000 mg POMx daily for 4 weeks"
11035212|NCT01227512|OG001|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction be may titrated based on serum sodium response.
11035213|NCT01227512|OG001|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based on serum sodium response.
11035214|NCT01227512|EG000|Reported Event|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
11035215|NCT01227512|EG001|Reported Event|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
11035216|NCT01227551|BG000|Baseline|CVA21|CVA21 monotherapy
11035217|NCT01227551|FG000|Participant Flow|CVA21|CVA21 monotherapy
11035218|NCT01227551|OG000|Outcome|CVA21|CVA21 monotherapy
11035219|NCT01227551|EG000|Reported Event|CVA21|CVA21 monotherapy
11035220|NCT01227564|BG000|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035221|NCT01227564|BG001|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035222|NCT01227564|BG002|Baseline|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035223|NCT01227564|BG003|Baseline|Total|Total of all reporting groups
11035224|NCT01227564|FG000|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035225|NCT01227564|FG001|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035226|NCT01227564|FG002|Participant Flow|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035227|NCT01227564|OG000|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035228|NCT01227564|OG001|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035229|NCT01227564|OG002|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035230|NCT01227564|OG003|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035231|NCT01227564|OG002|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11225909|NCT02370641|OG000|Outcome|Microbial Phylum Abundance in Urolithin Excretors|Microbial phylum abundance (% of total) in urolithin excretors after consumption of 1000 mg pomegranate extract daily for 4 weeks
11035232|NCT01227564|EG000|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035233|NCT01227564|EG001|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035234|NCT01227564|EG002|Reported Event|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
11035235|NCT01227577|BG000|Baseline|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
11035236|NCT01227577|FG000|Participant Flow|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
11035237|NCT01227577|OG000|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
11035238|NCT01227577|EG000|Reported Event|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
11035239|NCT01227629|BG000|Baseline|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
11035240|NCT01227629|BG001|Baseline|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
11035241|NCT01227629|BG002|Baseline|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035242|NCT01227629|BG003|Baseline|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
11035243|NCT01227629|BG004|Baseline|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
11035244|NCT01227629|BG005|Baseline|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035245|NCT01227629|BG006|Baseline|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
11035246|NCT01227629|BG007|Baseline|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
11035247|NCT01227629|BG008|Baseline|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035248|NCT01227629|BG009|Baseline|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
11035249|NCT01227629|BG010|Baseline|Total|Total of all reporting groups
11035250|NCT01227629|FG000|Participant Flow|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
11035251|NCT01227629|FG001|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
11035252|NCT01227629|FG002|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035253|NCT01227629|FG003|Participant Flow|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
11035254|NCT01227629|FG004|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
11035255|NCT01227629|FG005|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035256|NCT01227629|FG006|Participant Flow|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
11035257|NCT01227629|FG007|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
11035258|NCT01227629|FG008|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035259|NCT01227629|FG009|Participant Flow|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
11035260|NCT01227629|OG000|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
11035261|NCT01227629|OG001|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
11035262|NCT01227629|OG002|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035263|NCT01227629|OG003|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
11035264|NCT01227629|OG004|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
11035265|NCT01227629|OG005|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035266|NCT01227629|OG006|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
11035267|NCT01227629|OG007|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
11035268|NCT01227629|OG008|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
11035269|NCT01227629|OG009|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
11035270|NCT01227629|OG000|Outcome|D50bid|Dabigatran 50 mg twice daily
11035271|NCT01227629|OG001|Outcome|D50qd|Dabigatran 50 mg once daily
11035272|NCT01227629|OG002|Outcome|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
11035273|NCT01227629|OG003|Outcome|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
11035274|NCT01227629|OG004|Outcome|D150bid|Dabigatran 150 mg twice daily
11035275|NCT01227629|OG005|Outcome|D150qd|Dabigatran 150 mg once daily
11035276|NCT01227629|OG006|Outcome|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
11035277|NCT01227629|OG007|Outcome|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
11035278|NCT01227629|OG008|Outcome|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
11035279|NCT01227629|OG009|Outcome|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
11035280|NCT01227629|OG010|Outcome|D300bid|Dabigatran 300 mg twice daily
11035281|NCT01227629|OG011|Outcome|D300qd|Dabigatran 300 mg once daily
11035282|NCT01227629|OG012|Outcome|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
11035283|NCT01227629|OG013|Outcome|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
11035284|NCT01227629|OG014|Outcome|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
11035285|NCT01227629|OG015|Outcome|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
11035286|NCT01227629|OG016|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|Warfarin once daily
11035287|NCT01227629|EG000|Reported Event|D50bid|Dabigatran 50 mg twice daily
11035288|NCT01227629|EG001|Reported Event|D50qd|Dabigatran 50 mg once daily
11035289|NCT01227629|EG002|Reported Event|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
11035290|NCT01227629|EG003|Reported Event|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
11035291|NCT01227629|EG004|Reported Event|D150bid|Dabigatran 150 mg twice daily
11035292|NCT01227629|EG005|Reported Event|D150qd|Dabigatran 150 mg once daily
11035293|NCT01227629|EG006|Reported Event|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
11035294|NCT01227629|EG007|Reported Event|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
11035295|NCT01227629|EG008|Reported Event|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
11035296|NCT01227629|EG009|Reported Event|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
11035297|NCT01227629|EG010|Reported Event|D300bid|Dabigatran 300 mg twice daily
11035298|NCT01227629|EG011|Reported Event|D300qd|Dabigatran 300 mg once daily
11225910|NCT02370641|OG001|Outcome|Microbial Phylum Abundance in Non Excretors|Microbial phylum abundance (% of total) in urolithin excretors after consumption of 1000 mg pomegranate extract daily for 4 weeks.
11035299|NCT01227629|EG012|Reported Event|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
11035300|NCT01227629|EG013|Reported Event|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
11035301|NCT01227629|EG014|Reported Event|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
11225911|NCT02370641|EG000|Reported Event|Microbial Phylum Abundance in Urolithin Excretors|microbial phylum abundance in urolithin excretors after consumption of 1000 mg pomegranate extract daily for 4 weeks
11035302|NCT01227629|EG015|Reported Event|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
11035303|NCT01227629|EG016|Reported Event|Warfarin|Warfarin once daily
11035304|NCT01227655|BG000|Baseline|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
11035305|NCT01227655|BG001|Baseline|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
11035306|NCT01227655|BG002|Baseline|Placebo|Placebo: comparator
11035307|NCT01227655|BG003|Baseline|Total|Total of all reporting groups
11035308|NCT01227655|FG000|Participant Flow|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
11035309|NCT01227655|FG001|Participant Flow|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
11035310|NCT01227655|FG002|Participant Flow|Placebo|Placebo: comparator
11035311|NCT01227655|OG000|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
11035312|NCT01227655|OG001|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
11035313|NCT01227655|OG002|Outcome|Placebo|Placebo: comparator
11035314|NCT01227655|EG000|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
11035315|NCT01227655|EG001|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
11035316|NCT01227655|EG002|Reported Event|Placebo|Placebo: comparator
11035317|NCT01227668|BG000|Baseline|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
11035318|NCT01227668|BG001|Baseline|Placebo|Phase 2: Participants received placebo for 16 weeks.
11035319|NCT01227668|BG002|Baseline|Total|Total of all reporting groups
11035320|NCT01227668|FG000|Participant Flow|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|"Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.~Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability."
11035321|NCT01227668|FG001|Participant Flow|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
11035322|NCT01227668|OG000|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
11035323|NCT01227668|OG001|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
11035324|NCT01227668|OG000|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole (ARP) at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
11035325|NCT01227668|OG001|Outcome|Placebo|Phase 2 only: Participants received placebo (pb)for 16 weeks.
11035326|NCT01227668|OG000|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
11035327|NCT01227668|EG000|Reported Event|Aripiprazole, 2-15 mg (Phase 1)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
11035328|NCT01227668|EG001|Reported Event|Aripiprazole, 2-15 mg (Phase 2)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
11035329|NCT01227668|EG002|Reported Event|Placebo (Phase 2 Only)|Phase 2 only: Participants received placebo for 16 weeks.
11035330|NCT01227681|BG000|Baseline|High Dose G-CSF Injection for Parkinson's Disease|3.3 ug/kg/day for consecutive 5 days of each 60 day cycle
11035331|NCT01227681|BG001|Baseline|Low Dose G-CSF Injection for Parkinson's Disease|1.65 ug/kg/day for consecutive 5 days of each 60 day cycle
11035332|NCT01227681|BG002|Baseline|Placebo|normal saline 0.9% injection
11035333|NCT01227681|BG003|Baseline|Total|Total of all reporting groups
11035334|NCT01227681|FG000|Participant Flow|G-CSF|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
11035335|NCT01227681|FG001|Participant Flow|Low Dose G-CSF|1.65ug/kg/day for consecutive 5 days of each 60 day cycle
11035336|NCT01227681|FG002|Participant Flow|Placebo|subcutaneous Normal saline for consecutive 5 days of each 60 day cycle
11035337|NCT01227681|OG000|Outcome|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
11035338|NCT01227681|EG000|Reported Event|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
11035339|NCT01227707|BG000|Baseline|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
11035340|NCT01227707|FG000|Participant Flow|Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
11035341|NCT01227707|OG000|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
11035342|NCT01227707|EG000|Reported Event|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
11035343|NCT01227785|BG000|Baseline|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
11035344|NCT01227785|FG000|Participant Flow|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
11035345|NCT01227785|OG000|Outcome|INCEPTA CRT-D Patients|
11035346|NCT01227785|OG000|Outcome|Group1: Patients With a HFE|Patients who experienced a protocol-defined HF event
11035347|NCT01227785|OG001|Outcome|Group 2: Patients Without a HFE|Patients who did not experience a protocol-defined HFE
11035348|NCT01227785|OG001|Outcome|INCEPTA ICD Patients|
11035349|NCT01227785|OG000|Outcome|INCEPTA CRT-D and ICD Patients (Overall Study Population)|
11035350|NCT01227785|OG000|Outcome|INCEPTA CRT-D|
11035351|NCT01227785|OG001|Outcome|INCEPTA ICD|
11035352|NCT01227785|OG000|Outcome|INCEPTA CRT-D and ICD (Overall Study Population)|
11035353|NCT01227785|EG000|Reported Event|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
11035354|NCT01227824|BG000|Baseline|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF)/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
11035355|NCT01227824|BG001|Baseline|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
11035356|NCT01227824|BG002|Baseline|Total|Total of all reporting groups
11035357|NCT01227824|FG000|Participant Flow|DTG 50 mg Once a Day|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
11035358|NCT01227824|FG001|Participant Flow|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
11035359|NCT01227824|FG002|Participant Flow|DTG 50 mg Once a Day (Open-label)|Participants who successfully completed 96 weeks of double blind phase continued to receive DTG 50 mg once a day during open label phase, until dolutegravir was locally available commercially. Participants received DTG 50 mg once a day in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.
11035360|NCT01227824|OG000|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
11035361|NCT01227824|OG001|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
11035362|NCT01227824|EG000|Reported Event|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
11035363|NCT01227824|EG001|Reported Event|RTG 400mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
11035364|NCT01227824|EG002|Reported Event|DTG 50 mg Once a Day (Open-label)|Participants who successfully completed 96 weeks of double blind phase continued to receive DTG 50 mg once a day during open label phase, until DTG was locally available commercially. Participants received DTG 50 mg once a day in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.
11035365|NCT01227889|BG000|Baseline|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
11035366|NCT01227889|BG001|Baseline|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
11035367|NCT01227889|BG002|Baseline|Total|Total of all reporting groups
11035368|NCT01227889|FG000|Participant Flow|GSK2118436 150 mg BID|Participants (par.) were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
11035369|NCT01227889|FG001|Participant Flow|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received intravenous (IV) Dacarbazine (DTIC) 1000 mg per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
11035370|NCT01227889|OG000|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
11035371|NCT01227889|OG001|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received intravenous (IV) Dacarbazine (DTIC) 1000 milligrams per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
11035372|NCT01227889|OG000|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
11035373|NCT01227889|OG001|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
11035374|NCT01227889|OG001|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
11035375|NCT01227889|OG000|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable adverse AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
11035376|NCT01227889|OG000|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
11035377|NCT01227889|OG000|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
11035378|NCT01227889|OG000|Outcome|All Screened Participants|Specimens were tested for V600E mutations to determine trial eligibility with the CTA were retested with the THxID BRAF test. The analytical agreement between the THxID BRAF and the CTA was evaluated for both mutation positive and mutation negative specimens from all sites.
11035379|NCT01227889|EG000|Reported Event|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
11035380|NCT01227889|EG001|Reported Event|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
11035381|NCT01227889|EG002|Reported Event|GSK25118436 in the Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
11035382|NCT01227902|BG000|Baseline|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035383|NCT01227902|BG001|Baseline|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035384|NCT01227902|BG002|Baseline|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035385|NCT01227902|BG003|Baseline|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035386|NCT01227902|BG004|Baseline|Total|Total of all reporting groups
11035387|NCT01227902|FG000|Participant Flow|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035388|NCT01227902|FG001|Participant Flow|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035389|NCT01227902|FG002|Participant Flow|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035390|NCT01227902|FG003|Participant Flow|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035391|NCT01227902|OG000|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035392|NCT01227902|OG001|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035393|NCT01227902|OG002|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035394|NCT01227902|OG003|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035395|NCT01227902|OG004|Outcome|Total|All four antiepileptic drug treatment arms combined
11035396|NCT01227902|EG000|Reported Event|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035397|NCT01227902|EG001|Reported Event|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035398|NCT01227902|EG002|Reported Event|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035399|NCT01227902|EG003|Reported Event|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
11035400|NCT01227928|BG000|Baseline|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
11035401|NCT01227928|BG001|Baseline|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
11035402|NCT01227928|BG002|Baseline|Total|Total of all reporting groups
11035403|NCT01227928|FG000|Participant Flow|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
11035404|NCT01227928|FG001|Participant Flow|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
11035405|NCT01227928|OG000|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
11035406|NCT01227928|OG001|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
11035407|NCT01227928|EG000|Reported Event|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
11225912|NCT02370641|EG001|Reported Event|Microbial Phylum Abundance in Urolithin Non Excretors|"The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.~PomX: 1000 mg POMx daily for 4 weeks"
11225913|NCT02370667|BG000|Baseline|Biomechanical Exercise (BE)|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.~Biomechanical Exercise (BE): A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
11225914|NCT02370667|BG001|Baseline|Traditional Exercise (TE)|"The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.~Traditional Exercise (TE): A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
11225915|NCT02370667|BG002|Baseline|Meditation Control (M)|"The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.~Meditation Control (M): A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
11225916|NCT02370667|BG003|Baseline|Total|Total of all reporting groups
11225917|NCT02370667|FG000|Participant Flow|Biomechanical Exercise (BE)|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.~Biomechanical Exercise (BE): A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
11225918|NCT02370667|FG001|Participant Flow|Traditional Exercise (TE)|"The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.~Traditional Exercise (TE): A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
11225919|NCT02370667|FG002|Participant Flow|Meditation Control (M)|"The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.~Meditation Control (M): A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
11225920|NCT02370667|OG000|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
11035408|NCT01227928|EG001|Reported Event|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
11035409|NCT01227954|BG000|Baseline|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
11035410|NCT01227954|FG000|Participant Flow|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
11035411|NCT01227954|OG000|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
11035412|NCT01227954|EG000|Reported Event|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
11035413|NCT01227967|BG000|Baseline|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
11035414|NCT01227967|BG001|Baseline|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
11035415|NCT01227967|BG002|Baseline|Total|Total of all reporting groups
11035416|NCT01227967|FG000|Participant Flow|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
11035417|NCT01227967|FG001|Participant Flow|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
11035418|NCT01227967|OG000|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
11035419|NCT01227967|OG001|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
11035420|NCT01227967|EG000|Reported Event|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
11035421|NCT01227967|EG001|Reported Event|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
11225921|NCT02370667|OG001|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
11225922|NCT02370667|OG002|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
11035422|NCT01227980|BG000|Baseline|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
11035423|NCT01227980|BG001|Baseline|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
11035424|NCT01227980|BG002|Baseline|Total|Total of all reporting groups
11035425|NCT01227980|FG000|Participant Flow|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
11035426|NCT01227980|FG001|Participant Flow|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
11035427|NCT01227980|OG000|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
11035428|NCT01227980|OG001|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
11035429|NCT01227980|EG000|Reported Event|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
11035430|NCT01227980|EG001|Reported Event|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
11035431|NCT01227993|BG000|Baseline|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
11035432|NCT01227993|FG000|Participant Flow|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
11035433|NCT01227993|OG000|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
11035434|NCT01227993|EG000|Reported Event|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
11035435|NCT01228019|BG000|Baseline|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
11035436|NCT01228019|FG000|Participant Flow|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
11035437|NCT01228019|OG000|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
11035438|NCT01228019|EG000|Reported Event|ALL PARTICIPANTS|
11035439|NCT01228071|BG000|Baseline|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
11035440|NCT01228071|FG000|Participant Flow|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
11035441|NCT01228071|OG000|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
11035442|NCT01228071|EG000|Reported Event|EN3350 (Testosterone Gel 2%)|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
11035443|NCT01228084|BG000|Baseline|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
11035444|NCT01228084|FG000|Participant Flow|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
11035445|NCT01228084|OG000|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
11035446|NCT01228084|EG000|Reported Event|Sulpforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic
11035447|NCT01228149|BG000|Baseline|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11035448|NCT01228149|BG001|Baseline|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11035449|NCT01228149|BG002|Baseline|Total|Total of all reporting groups
11035450|NCT01228149|FG000|Participant Flow|Diamox/DexaEDO|"Patients receive oral acetazolamide starting 28 days preoperatively. 7 days preoperatively dexamethasone eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11035451|NCT01228149|FG001|Participant Flow|Cosopt S|"Patients receive Cosopt S eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11035452|NCT01228149|OG000|Outcome|Diamox/DexaEDO|"Patients receive oral Diamox (acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11035453|NCT01228149|OG001|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11149061|NCT01868477|FG000|Participant Flow|Erythropoietin Alpha|Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
11149062|NCT01868477|FG001|Participant Flow|Deferasirox + Erythropoietin Alpha|Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study
11149063|NCT01868477|OG000|Outcome|Erythropoietin Alpha|Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
11149064|NCT01868477|OG001|Outcome|Deferasirox + Erythropoietin Alpha|Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study
11149065|NCT01868477|OG000|Outcome|EPO+DFX (12 Weeks)|Patients randomized to EPO alone with inadequate response at 12 weeks who had been switched over to combination EPO+DFX
11149066|NCT01868477|OG000|Outcome|EPO (24 Weeks)|Patients who were in EPO alone group and were not switched to EPO+DFX after 12 weeks,
11149067|NCT01868477|OG000|Outcome|Deferasirox + Erythropoietin Alpha|Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study
11149068|NCT01868477|OG000|Outcome|EPO+DFX at 12|Patients randomized to EPO alone with inadequate response at 12 weeks who had been switched over to combination EPO+DFX
11149069|NCT01868477|OG000|Outcome|EPO+DFX at 12 Weeks|This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy. The time-course of Hb and its absolute changes from baseline was summarized by descriptive statistics by visit and erythroid response. Patients randomized to EPO and not switching after 12 weeks to EPO+DFX would consist of only responders
11149070|NCT01868477|EG000|Reported Event|EPO A|Patients receiving EPO during the first 12 weeks and no switching to EPO+DFX arm
11149071|NCT01868477|EG001|Reported Event|EPO+DFX DT|Patients receiving EPO+DFX from week 1 and continuing with EPO+DFX after 12 weeks or with DFX alone after 12 weeks
11035454|NCT01228149|OG000|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.~Trabeculectomy with preoperative Diamox/DexaEDO treatment: Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery"
11035455|NCT01228149|OG001|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.~Trabeculectomy with preoperative Cosopt S treatment: Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery."
11035456|NCT01228149|OG000|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11035457|NCT01228149|EG000|Reported Event|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11035458|NCT01228149|EG001|Reported Event|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
11035459|NCT01228175|BG000|Baseline|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
11035460|NCT01228175|BG001|Baseline|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
11035461|NCT01228175|BG002|Baseline|Total|Total of all reporting groups
11035462|NCT01228175|FG000|Participant Flow|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
11035463|NCT01228175|FG001|Participant Flow|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
11035464|NCT01228175|OG000|Outcome|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
11035465|NCT01228175|OG001|Outcome|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
11035466|NCT01228175|EG000|Reported Event|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
11035467|NCT01228175|EG001|Reported Event|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
11035468|NCT01228318|BG000|Baseline|Zoledronic Acid|Participants in this arm received a 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.
11035469|NCT01228318|BG001|Baseline|Placebo|Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel.
11035470|NCT01228318|BG002|Baseline|Total|Total of all reporting groups
11035471|NCT01228318|FG000|Participant Flow|Zoledronic Acid|"Participants in this arm received a 5 milligrams (mg)/100 milliliter (mL) solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.~Study visits occurred at 12, 24, 48, 96, and 144 weeks."
11035472|NCT01228318|FG001|Participant Flow|Placebo|"Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel.~Study visits occurred at 12, 24, 48, 96, and 144 weeks."
11035473|NCT01228318|OG000|Outcome|Zoledronic Acid|"Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.~Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.~b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes."
11035474|NCT01228318|OG001|Outcome|Placebo|"Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel.~Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.~b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes."
11035475|NCT01228318|EG000|Reported Event|Zoledronic Acid|Participants in this arm received a 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.
11035476|NCT01228318|EG001|Reported Event|Placebo|Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel.
11035477|NCT01228435|BG000|Baseline|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
11035478|NCT01228435|BG001|Baseline|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
11035479|NCT01228435|BG002|Baseline|Total|Total of all reporting groups
11035480|NCT01228435|FG000|Participant Flow|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
11035481|NCT01228435|FG001|Participant Flow|ALK-inhibitor Pre-treated|Patients in this arm had prior exposure to an ALK inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
11035482|NCT01228435|OG000|Outcome|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
11035483|NCT01228435|OG001|Outcome|ALK-inhibitor Pre-treated|Patients in this arm had received prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
11035484|NCT01228435|EG000|Reported Event|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
11035485|NCT01228435|EG001|Reported Event|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
11035486|NCT01228591|BG000|Baseline|All Subjects|Subjects who were randomized and successfully completed the study.
11035487|NCT01228591|FG000|Participant Flow|Acuvue Advance Plus/ Acuvue Advance|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
11035488|NCT01228591|FG001|Participant Flow|Acuvue Advance/ Acuvue Advance Plus|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
11035489|NCT01228591|OG000|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses-Binocular measurements
11035490|NCT01228591|OG001|Outcome|Acuvue Advance|Acuvue Advance contact lenses - Binocular Measurements
11035491|NCT01228591|OG000|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
11035492|NCT01228591|OG001|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
11035493|NCT01228591|OG000|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
11035494|NCT01228591|OG001|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
11035495|NCT01228591|EG000|Reported Event|Acuvue Advance Plus|Acuvue Advance Plus contact lenses
11035496|NCT01228591|EG001|Reported Event|Acuvue Advance|Acuvue Advance contact lenses
11035497|NCT01228734|BG000|Baseline|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
11035498|NCT01228734|BG001|Baseline|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
11035499|NCT01228734|BG002|Baseline|Total|Total of all reporting groups
11035500|NCT01228734|FG000|Participant Flow|Cetuximab + FOLFOX4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab was always administered every 7 days with an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
11035501|NCT01228734|FG001|Participant Flow|FOLFOX4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
11035502|NCT01228734|OG000|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
11035503|NCT01228734|OG001|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
11066461|NCT01392469|FG000|Participant Flow|Imatinib+ Bosentan+ Sildenafil|Participants received treatment with bosentan 125 mg twice daily and sildenafil thrice daily for 8 days in treatment period 1. Participants were on the same sildenafil dose level (20, 40, 50 or 60 mg) they had been at study entry which was well tolerated in conjunction with bosentan. Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2. Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.
11035504|NCT01228734|EG000|Reported Event|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
11035505|NCT01228734|EG001|Reported Event|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
11035506|NCT01228747|BG000|Baseline|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily"
11035507|NCT01228747|BG001|Baseline|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
11035508|NCT01228747|BG002|Baseline|Total|Total of all reporting groups
11035509|NCT01228747|FG000|Participant Flow|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
11035510|NCT01228747|FG001|Participant Flow|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
11035511|NCT01228747|OG000|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
11035512|NCT01228747|OG001|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
11035513|NCT01228747|EG000|Reported Event|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
11035514|NCT01228747|EG001|Reported Event|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
11035515|NCT01228903|BG000|Baseline|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
11035516|NCT01228903|BG001|Baseline|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
11035517|NCT01228903|BG002|Baseline|Total|Total of all reporting groups
11035518|NCT01228903|FG000|Participant Flow|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
11035519|NCT01228903|FG001|Participant Flow|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
11035520|NCT01228903|OG000|Outcome|Control|Placebo: Placebo tablets with no active ingredient
11035521|NCT01228903|OG001|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
11035522|NCT01228903|EG000|Reported Event|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
11035523|NCT01228903|EG001|Reported Event|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
11035524|NCT01228929|BG000|Baseline|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
11035525|NCT01228929|BG001|Baseline|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
11035526|NCT01228929|BG002|Baseline|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
11035527|NCT01228929|BG003|Baseline|Total|Total of all reporting groups
11035528|NCT01228929|FG000|Participant Flow|Normal|Subjects with no clinical diagnosis or symptoms of dry eye. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
11035529|NCT01228929|FG001|Participant Flow|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
11035530|NCT01228929|FG002|Participant Flow|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
11035531|NCT01228929|OG000|Outcome|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
11035532|NCT01228929|OG001|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
11035533|NCT01228929|OG002|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
11035534|NCT01228929|EG000|Reported Event|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
11035535|NCT01228929|EG001|Reported Event|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
11035536|NCT01228929|EG002|Reported Event|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
11035537|NCT01228968|BG000|Baseline|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
11035538|NCT01228968|FG000|Participant Flow|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
11035539|NCT01228968|OG000|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
11035540|NCT01228968|EG000|Reported Event|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
11035541|NCT01229111|BG000|Baseline|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
11035542|NCT01229111|FG000|Participant Flow|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
11035543|NCT01229111|OG000|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
11035544|NCT01229111|EG000|Reported Event|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
11035545|NCT01229150|BG000|Baseline|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
11035546|NCT01229150|BG001|Baseline|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
11035547|NCT01229150|BG002|Baseline|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
11035548|NCT01229150|BG003|Baseline|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
11035549|NCT01229150|BG004|Baseline|Total|Total of all reporting groups
11035550|NCT01229150|FG000|Participant Flow|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
11035551|NCT01229150|FG001|Participant Flow|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
11035552|NCT01229150|FG002|Participant Flow|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
11035553|NCT01229150|FG003|Participant Flow|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
11035554|NCT01229150|OG000|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
11035555|NCT01229150|OG001|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
11035556|NCT01229150|OG002|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
11035557|NCT01229150|OG003|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
11035558|NCT01229150|OG000|Outcome|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
11035559|NCT01229150|OG002|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
11035560|NCT01229150|OG000|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd."
11035561|NCT01229150|OG002|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd (every day)"
11035562|NCT01229150|OG003|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd."
11035563|NCT01229150|EG000|Reported Event|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
11035564|NCT01229150|EG001|Reported Event|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
11035565|NCT01229150|EG002|Reported Event|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
11035566|NCT01229176|BG000|Baseline|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
11035567|NCT01229176|BG001|Baseline|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
11035568|NCT01229176|BG002|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11035569|NCT01229176|BG003|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
11035570|NCT01229176|BG004|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11035571|NCT01229176|BG005|Baseline|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
11035572|NCT01229176|BG006|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
11035573|NCT01229176|BG007|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
11035574|NCT01229176|BG008|Baseline|Total|Total of all reporting groups
11035575|NCT01229176|FG000|Participant Flow|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
11035576|NCT01229176|FG001|Participant Flow|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
11035577|NCT01229176|FG002|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11035578|NCT01229176|FG003|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
11035579|NCT01229176|FG004|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11035580|NCT01229176|FG005|Participant Flow|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
11035581|NCT01229176|FG006|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
11035582|NCT01229176|FG007|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
11035583|NCT01229176|OG000|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
11035584|NCT01229176|OG001|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
11035585|NCT01229176|OG002|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11035586|NCT01229176|OG003|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
11035587|NCT01229176|OG004|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11035588|NCT01229176|OG005|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
11035589|NCT01229176|OG006|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
11035590|NCT01229176|OG007|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
11035591|NCT01229176|EG000|Reported Event|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
11035592|NCT01229176|EG001|Reported Event|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
11035593|NCT01229176|EG002|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11035594|NCT01229176|EG003|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
11035595|NCT01229176|EG004|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11035596|NCT01229176|EG005|Reported Event|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
11035597|NCT01229176|EG006|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
11035598|NCT01229176|EG007|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
11035599|NCT01229228|BG000|Baseline|Naproxen Test (Lower Dose)|
11035600|NCT01229228|BG001|Baseline|Naproxen Test (Upper Dose)|
11035601|NCT01229228|BG002|Baseline|Naprosyn 250 mg|
11035602|NCT01229228|BG003|Baseline|Naprosyn 500 mg|
11035603|NCT01229228|BG004|Baseline|Placebo|
11035604|NCT01229228|BG005|Baseline|Total|Total of all reporting groups
11035605|NCT01229228|FG000|Participant Flow|Naproxen Test (Lower Dose)|
11035606|NCT01229228|FG001|Participant Flow|Naproxen Test (Upper Dose)|
11035607|NCT01229228|FG002|Participant Flow|Naprosyn 250 mg|
11035608|NCT01229228|FG003|Participant Flow|Naprosyn 500 mg|
11035609|NCT01229228|FG004|Participant Flow|Placebo|
11035610|NCT01229228|OG000|Outcome|Naproxen Test (Lower Dose)|200-mg single dose
11035611|NCT01229228|OG001|Outcome|Naproxen Test (Upper Dose)|400-mg (2 x 200-mg)
11035612|NCT01229228|OG002|Outcome|Naprosyn 250 mg|
11035613|NCT01229228|OG003|Outcome|Naprosyn 500 mg|
11035614|NCT01229228|OG004|Outcome|Placebo|
11035615|NCT01229228|EG000|Reported Event|Naproxen Test (Lower Dose)|
11035616|NCT01229228|EG001|Reported Event|Naproxen Test (Upper Dose)|
11035617|NCT01229228|EG002|Reported Event|Naprosyn 250 mg|
11035618|NCT01229228|EG003|Reported Event|Naprosyn 500 mg|
11035619|NCT01229228|EG004|Reported Event|Placebo|
11035620|NCT01229254|BG000|Baseline|Betrixaban 30 mg (+Amiodarone)|Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
11035621|NCT01229254|BG001|Baseline|Betrixaban 60 mg (<80 kg)|Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
11035622|NCT01229254|BG002|Baseline|Betrixaban 90 mg (≥80 kg)|Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
11035623|NCT01229254|BG003|Baseline|Total|Total of all reporting groups
11035624|NCT01229254|FG000|Participant Flow|Betrixaban 30 mg (+Amiodarone)|Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
11035625|NCT01229254|FG001|Participant Flow|Betrixaban 60 mg (<80 kg)|Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
11035626|NCT01229254|FG002|Participant Flow|Betrixaban 90 mg (≥80 kg)|Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
11035627|NCT01229254|OG000|Outcome|Betrixaban 30 mg (+Amiodarone)|Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
11035628|NCT01229254|OG001|Outcome|Betrixaban 60 mg (<80 kg)|Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
11035629|NCT01229254|OG002|Outcome|Betrixaban 90 mg (≥80 kg)|Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
11035630|NCT01229254|OG000|Outcome|Betrixaban|Betrixaban 30 mg once daily for patients taking amiodarone, plus Betrixaban 60 mg once daily, plus Betrixaban 90 mg once daily, all for at least 4 weeks and up to 24 weeks
11035631|NCT01229254|EG000|Reported Event|Betrixaban 30 mg (+Amiodarone)|Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
11035632|NCT01229254|EG001|Reported Event|Betrixaban 60 mg (<80 kg)|Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
11035633|NCT01229254|EG002|Reported Event|Betrixaban 90 mg (≥80 kg)|Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
11035634|NCT01229267|BG000|Baseline|V212 Consistency Lot 1|Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035635|NCT01229267|BG001|Baseline|V212 Consistency Lot 2|Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035636|NCT01229267|BG002|Baseline|V212 Consistency Lot 3|Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035637|NCT01229267|BG003|Baseline|V212 High Antigen Lot|Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035638|NCT01229267|BG004|Baseline|Placebo|Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035639|NCT01229267|BG005|Baseline|Total|Total of all reporting groups
11035640|NCT01229267|FG000|Participant Flow|V212 Consistency Lot 1|Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035641|NCT01229267|FG001|Participant Flow|V212 Consistency Lot 2|Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035642|NCT01229267|FG002|Participant Flow|V212 Consistency Lot 3|Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035643|NCT01229267|FG003|Participant Flow|V212 High Antigen Lot|Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035644|NCT01229267|FG004|Participant Flow|Placebo|Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035645|NCT01229267|OG000|Outcome|V212 Consistency Lots|Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035646|NCT01229267|OG001|Outcome|Placebo|Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035647|NCT01229267|OG000|Outcome|All V212 (Including High Antigen Lot)|V212 (all lots, including High Antigen Lot) administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.
11035648|NCT01229267|EG000|Reported Event|V212 [Including High Antigen Lot]|Participants received V212 Consistency Lot 1, 2, 3 or High Antigen Lot 0.5 mL administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.
11035649|NCT01229267|EG001|Reported Event|Placebo|Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
11035650|NCT01229371|BG000|Baseline|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
11035651|NCT01229371|BG001|Baseline|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
11035652|NCT01229371|BG002|Baseline|Subjects >60 Years - AdImmune HA Antigen|
11035653|NCT01229371|BG003|Baseline|Subjects >60 Years - CSL HA Antigen|
11035654|NCT01229371|BG004|Baseline|Total|Total of all reporting groups
11035655|NCT01229371|FG000|Participant Flow|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
11035656|NCT01229371|FG001|Participant Flow|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
11035657|NCT01229371|FG002|Participant Flow|Subjects >60 Years - AdImmune HA Antigen|
11035658|NCT01229371|FG003|Participant Flow|Subjects >60 Years - CSL HA Antigen|
11035659|NCT01229371|OG000|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
11035660|NCT01229371|OG001|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
11035661|NCT01229371|OG002|Outcome|Subjects >60 Years - AdImmune HA Antigen|
11035662|NCT01229371|OG003|Outcome|Subjects >60 Years - CSL HA Antigen|
11035663|NCT01229371|EG000|Reported Event|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
11035664|NCT01229371|EG001|Reported Event|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
11035665|NCT01229371|EG002|Reported Event|Subjects >60 Years - AdImmune HA Antigen|
11035666|NCT01229371|EG003|Reported Event|Subjects >60 Years - CSL HA Antigen|
11035667|NCT01229397|BG000|Baseline|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
11035668|NCT01229397|BG001|Baseline|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
11035669|NCT01229397|BG002|Baseline|Total|Total of all reporting groups
11035670|NCT01229397|FG000|Participant Flow|Inflexal V 0.25 mL x 2|"2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:~7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus~7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus~7.5 μg HA antigen of B/Brisbane/60/2008-like virus"
11035671|NCT01229397|FG001|Participant Flow|Inflexal V 0.5 mL x 1|"1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:~15 μg HA antigen of A/California/7/2009 (H1N1)-like virus~15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus~15 μg HA antigen of B/Brisbane/60/2008-like virus"
11035672|NCT01229397|OG000|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
11035673|NCT01229397|OG001|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
11035674|NCT01229397|OG000|Outcome|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
11035675|NCT01229397|OG001|Outcome|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
11035676|NCT01229397|OG002|Outcome|Inflexal V 0.5 mL x 1|
11035677|NCT01229397|EG000|Reported Event|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
11035678|NCT01229397|EG001|Reported Event|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
11035679|NCT01229397|EG002|Reported Event|Inflexal V 0.5 mL x 1|
11035680|NCT01229410|BG000|Baseline|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
11035681|NCT01229410|BG001|Baseline|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
11035682|NCT01229410|BG002|Baseline|Total|Total of all reporting groups
11035683|NCT01229410|FG000|Participant Flow|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
11035684|NCT01229410|FG001|Participant Flow|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
11035685|NCT01229410|OG000|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
11035686|NCT01229410|OG001|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
11035687|NCT01229410|EG000|Reported Event|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
11035688|NCT01229410|EG001|Reported Event|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
11035689|NCT01229423|BG000|Baseline|LATISSE®|bimatoprost 0.03% (LATISSE®)
11035690|NCT01229423|FG000|Participant Flow|LATISSE®|bimatoprost 0.03% (LATISSE®)
11035691|NCT01229423|OG000|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
11035692|NCT01229423|EG000|Reported Event|LATISSE®|bimatoprost 0.03% (LATISSE®)
11035693|NCT01229436|BG000|Baseline|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
11035694|NCT01229436|FG000|Participant Flow|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
11035695|NCT01229436|OG000|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
11035696|NCT01229436|EG000|Reported Event|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
11035697|NCT01229449|BG000|Baseline|Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)|One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
11035698|NCT01229449|BG001|Baseline|Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)|Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
11035699|NCT01229449|BG002|Baseline|Nurofen Plus®|Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
11035700|NCT01229449|BG003|Baseline|Panadeine® Extra|Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
11035701|NCT01229449|BG004|Baseline|Placebo|Two placebo tablets by mouth
11035702|NCT01229449|BG005|Baseline|Total|Total of all reporting groups
11035703|NCT01229449|FG000|Participant Flow|Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)|One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth (single dose)
11035704|NCT01229449|FG001|Participant Flow|Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)|Two tablets of ibuprofen 200 mg plus two tablets of acetaminophen 500 mg by mouth (single dose)
11035705|NCT01229449|FG002|Participant Flow|Nurofen Plus®|Two tablets ibuprofen 200 mg plus codeine 12.8 mg (Nurofen Plus®) by mouth (single dose)
11035706|NCT01229449|FG003|Participant Flow|Panadeine® Extra|Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth (single dose)
11035707|NCT01229449|FG004|Participant Flow|Placebo|Two placebo tablets by mouth
11035708|NCT01229449|OG000|Outcome|Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)|One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
11035709|NCT01229449|OG001|Outcome|Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)|Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
11035710|NCT01229449|OG002|Outcome|Nurofen Plus®|Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
11035711|NCT01229449|OG003|Outcome|Panadeine® Extra|Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
11035712|NCT01229449|OG004|Outcome|Placebo|Two placebo tablets by mouth
11225923|NCT02370667|EG000|Reported Event|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
11035713|NCT01229449|EG000|Reported Event|Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)|One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
11035714|NCT01229449|EG001|Reported Event|Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)|Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
11035715|NCT01229449|EG002|Reported Event|Nurofen Plus®|Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
11035716|NCT01229449|EG003|Reported Event|Panadeine® Extra|Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
11035717|NCT01229449|EG004|Reported Event|Placebo|Two placebo tablets by mouth
11035718|NCT01229462|BG000|Baseline|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
11035719|NCT01229462|BG001|Baseline|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
11035720|NCT01229462|BG002|Baseline|Total|Total of all reporting groups
11035721|NCT01229462|FG000|Participant Flow|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
11035722|NCT01229462|FG001|Participant Flow|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
11035723|NCT01229462|OG000|Outcome|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
11035724|NCT01229462|OG001|Outcome|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
11035725|NCT01229462|EG000|Reported Event|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
11035726|NCT01229462|EG001|Reported Event|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
11035727|NCT01229527|BG000|Baseline|Remifentanil RS1|
11035728|NCT01229527|BG001|Baseline|Remifentanil RS2|
11035729|NCT01229527|BG002|Baseline|Meperidine|
11035730|NCT01229527|BG003|Baseline|Total|Total of all reporting groups
11035731|NCT01229527|FG000|Participant Flow|Remifentanil RS1|
11035732|NCT01229527|FG001|Participant Flow|Remifentanil RS2|
11225924|NCT02370667|EG001|Reported Event|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
11225925|NCT02370667|EG002|Reported Event|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
11035733|NCT01229527|FG002|Participant Flow|Meperidine|
11035734|NCT01229527|OG000|Outcome|Remifentanil RS1|
11035735|NCT01229527|OG001|Outcome|Remifentanil RS2|
11035736|NCT01229527|OG002|Outcome|Meperidine|
11035737|NCT01229527|EG000|Reported Event|Remifentanil RS1|
11035738|NCT01229527|EG001|Reported Event|Remifentanil RS2|
11035739|NCT01229527|EG002|Reported Event|Meperidine|
11035740|NCT01229722|BG000|Baseline|Beeper (Control)|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
11035741|NCT01229722|BG001|Baseline|Cell Phone (Intervention)|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
11035742|NCT01229722|BG002|Baseline|Total|Total of all reporting groups
11035743|NCT01229722|FG000|Participant Flow|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
11035744|NCT01229722|FG001|Participant Flow|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
11035745|NCT01229722|OG000|Outcome|Beeper (Control)|Patients randomized to the control arm (Beeper) received the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects were simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They did not receive any text messages addressing their adherence to ART between each study visit. Their providers did not receive any adherence reports but were asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
11035746|NCT01229722|OG001|Outcome|Cell Phone (Intervention)|"Participants received a text message reminder at scheduled intervals, with varying frequency. They potentially received a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates received a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
11035747|NCT01229722|OG000|Outcome|Beeper (Control)|"Patients randomized to the control arm (Beeper) received the standard of care at each clinic visit. The subjects brought their HIV medications every 3 weeks (MEMS measure, pill count) and were questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They did not receive any text messages addressing their adherence to ART between each study visit. Their providers did not receive any adherence reports, but were asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care.~Beeper: Beepers are handheld portable devices which can be attached to a belt. At regular intervals corresponding to the participant's preferred reminder time, they buzz for a few minutes or until the participant presses a button to stop the buzzing."
11035748|NCT01229722|OG001|Outcome|Cell Phone (Intervention)|"Participants received a text message reminder via ARemind at scheduled intervals, with varying frequency. They also potentially received a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those demonstrated lower adherence rates received a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
11149072|NCT01868477|EG002|Reported Event|EPO+DFX FCT|Patients receiving EPO alone and switched to EPO+DFX after 12 weeks of treatment
11149073|NCT01868477|EG003|Reported Event|Switched to DFX+EPO After 12 Weeks|Switched to DFX+EPO after 12 weeks
10849045|NCT00293397|BG000|Baseline|Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE)|"Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.~doxorubicin hydrochloride: Doxorubicin eluting beads"
11035749|NCT01229722|OG000|Outcome|Beeper (Control)|"Patients randomized to the control arm (Beeper) received the standard of care at each clinic visit. The subjects brought their HIV medications every 3 weeks (MEMS measure, pill count) and were questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They did not receive any text messages addressing their adherence to ART between each study visit. Their providers did not receive any adherence reports but were asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care.~Beeper: Beepers are handheld portable devices which can be attached to a belt. At regular intervals corresponding to the participant's preferred reminder time, they buzz for a few minutes or until the participant presses a button to stop the buzzing."
11225926|NCT02370693|BG000|Baseline|Bortezomib Plus Mycophenolate Mofetil|"Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Bortezomib: Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks"
11225927|NCT02370693|BG001|Baseline|Placebo Plus Mycophenolate Mofetil|"Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Placebo: Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks"
11225928|NCT02370693|BG002|Baseline|Enrolled But Not Randomized|Subjects who were enrolled (signed consent form) but did not continue through the screening process far enough to reach randomization.
11225929|NCT02370693|BG003|Baseline|Total|Total of all reporting groups
11225930|NCT02370693|FG000|Participant Flow|Bortezomib Plus Mycophenolate Mofetil|"Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Bortezomib: Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks"
11225931|NCT02370693|FG001|Participant Flow|Placebo Plus Mycophenolate Mofetil|"Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Placebo: Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks"
11035750|NCT01229722|OG001|Outcome|Cell Phone (Intervention)|"Participants received a text message reminder via ARemind at scheduled intervals, with varying frequency. They also potentially received a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrated lower adherence rates received a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
11066462|NCT01392469|OG000|Outcome|Bosentan + Sildenafil (Reference)|Participants received treatment with bosentan 125 mg twice daily and sildenafil thrice daily for 8 days in treatment period 1. Participants were on the same sildenafil dose level (20, 40, 50 or 60 mg) they had been at study entry which was well tolerated in conjunction with bosentan
11066463|NCT01392469|OG001|Outcome|Imatinib (200 mg/Day) + Bosentan + Sildenafil (Test 1)|Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2.
11066464|NCT01392469|OG002|Outcome|Imatinib (400 mg/Day) + Bosentan + Sildenafil (Test 2)|Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg tablet daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.
11225932|NCT02370693|OG000|Outcome|Bortezomib Plus Mycophenolate Mofetil|"Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Bortezomib: Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks"
11225933|NCT02370693|OG001|Outcome|Placebo Plus Mycophenolate Mofetil|"Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Placebo: Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks"
11225934|NCT02370693|EG000|Reported Event|Bortezomib Plus Mycophenolate Mofetil|"Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Bortezomib: Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks"
11225935|NCT02370693|EG001|Reported Event|Placebo Plus Mycophenolate Mofetil|"Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Placebo: Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks"
11225936|NCT02370784|BG000|Baseline|Atorvastatin 40 mg Daily|Atorvastatin 40 mg daily x 16 weeks
11225937|NCT02370784|BG001|Baseline|Placebo|Placebo daily x 16 weeks
11225938|NCT02370784|BG002|Baseline|Total|Total of all reporting groups
11035751|NCT01229722|EG000|Reported Event|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
11035752|NCT01229722|EG001|Reported Event|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
11035753|NCT01229735|BG000|Baseline|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
11035754|NCT01229735|BG001|Baseline|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
11035755|NCT01229735|BG002|Baseline|Total Title|
11035756|NCT01229735|FG000|Participant Flow|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
11035757|NCT01229735|FG001|Participant Flow|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
11035758|NCT01229735|OG000|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
11035759|NCT01229735|OG001|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
11035760|NCT01229735|OG000|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
11035761|NCT01229735|OG001|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
11035762|NCT01229735|EG000|Reported Event|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
11035763|NCT01229735|EG001|Reported Event|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
11035764|NCT01229891|BG000|Baseline|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
11035765|NCT01229891|BG001|Baseline|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
11035766|NCT01229891|BG002|Baseline|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
11035767|NCT01229891|BG003|Baseline|Total|Total of all reporting groups
11035768|NCT01229891|FG000|Participant Flow|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
11035769|NCT01229891|FG001|Participant Flow|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
11035770|NCT01229891|FG002|Participant Flow|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
11035771|NCT01229891|OG000|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
11035772|NCT01229891|OG001|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
11035773|NCT01229891|OG002|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
11035774|NCT01229891|EG000|Reported Event|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
11035775|NCT01229891|EG001|Reported Event|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
11035776|NCT01229891|EG002|Reported Event|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
11035777|NCT01230021|BG000|Baseline|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
11035778|NCT01230021|FG000|Participant Flow|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
11035779|NCT01230021|OG000|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
11225939|NCT02370784|FG000|Participant Flow|Atorvastatin 40 mg Daily|Length of intervention: 16 weeks atorvastatin: Atorvastatin is an oral cholesterol-lowering medication commonly referred to as statin therapy.
11035780|NCT01230021|EG000|Reported Event|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
11035781|NCT01230060|BG000|Baseline|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
11035782|NCT01230060|FG000|Participant Flow|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
11035783|NCT01230060|OG000|Outcome|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
11035784|NCT01230060|EG000|Reported Event|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
11035785|NCT01230125|BG000|Baseline|Mapracorat|"Ophthalmic suspension 3%~Mapracorat: Instill study medication into study eye per dosing instructions for 14 days"
11035786|NCT01230125|BG001|Baseline|Vehicle|"Vehicle of mapracorat ophthalmic suspension~Vehicle: Instill study medication into the study eye per dosing instructions for 14 days"
11035787|NCT01230125|BG002|Baseline|Total|Total of all reporting groups
11035788|NCT01230125|FG000|Participant Flow|Mapracorat|"Ophthalmic suspension 3%~Mapracorat: Instill study medication into study eye per dosing instructions for 14 days"
11035789|NCT01230125|FG001|Participant Flow|Vehicle|"Vehicle of mapracorat ophthalmic suspension~Vehicle: Instill study medication into the study eye per dosing instructions for 14 days"
11035790|NCT01230125|OG000|Outcome|Mapracorat|"Ophthalmic suspension 3%~Mapracorat: Instill study medication into study eye per dosing instructions for 14 days"
11035791|NCT01230125|OG001|Outcome|Vehicle|"Vehicle of mapracorat ophthalmic suspension~Vehicle: Instill study medication into the study eye per dosing instructions for 14 days"
11035792|NCT01230125|EG000|Reported Event|Mapracorat|"Ophthalmic suspension 3%~Mapracorat: Instill study medication into study eye per dosing instructions for 14 days"
11035793|NCT01230125|EG001|Reported Event|Vehicle|"Vehicle of mapracorat ophthalmic suspension~Vehicle: Instill study medication into the study eye per dosing instructions for 14 days"
11035794|NCT01230177|BG000|Baseline|Etanercept (Renetical Recombination)|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
11035795|NCT01230177|FG000|Participant Flow|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
11035796|NCT01230177|OG000|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
11035797|NCT01230177|EG000|Reported Event|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
11035798|NCT01230424|BG000|Baseline|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
11035799|NCT01230424|BG001|Baseline|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
11035800|NCT01230424|BG002|Baseline|Total|Total of all reporting groups
11035801|NCT01230424|FG000|Participant Flow|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
11035802|NCT01230424|FG001|Participant Flow|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
11035803|NCT01230424|OG000|Outcome|Triamcinolone Acetonide 40mg|All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
11035804|NCT01230424|OG001|Outcome|0.9% Sodium Chloride|All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
11035805|NCT01230424|OG000|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
11035806|NCT01230424|OG001|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
11035807|NCT01230424|OG001|Outcome|Sodium Chloride|"0.9% Sodium chloride injection as Placebo will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
11035808|NCT01230424|EG000|Reported Event|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
11035809|NCT01230424|EG001|Reported Event|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
11035810|NCT01230502|BG000|Baseline|Group 3: Donor Specific Regulation DSR -, Standard of Care|"Subjects who test DSR (donor specific regulation) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR(-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
11035811|NCT01230502|BG001|Baseline|Group 2 Donor Specific Regulation DSR +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR(+) standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
11035812|NCT01230502|BG002|Baseline|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
11035813|NCT01230502|BG003|Baseline|Total|Total of all reporting groups
11035814|NCT01230502|FG000|Participant Flow|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
11035815|NCT01230502|FG001|Participant Flow|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
11035816|NCT01230502|FG002|Participant Flow|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
11035817|NCT01230502|OG000|Outcome|Group 3: DSR (-), Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
11035818|NCT01230502|OG001|Outcome|Group 2 DSR (+); Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
11066465|NCT01392469|OG000|Outcome|Bosentan + Sildenafil (Reference)|Participants received treatment with bosentan 125 mg twice daily and sildenafil thrice daily for 8 days in treatment period 1. Participants were on the same sildenafil dose level (20, 40, 50 or 60 mg) they had been at study entry which was well tolerated in conjunction with bosentan.
11066466|NCT01392469|OG000|Outcome|Bosentan + Sildenafil|Participants received treatment with bosentan 125 mg twice daily and sildenafil thrice daily for 8 days in treatment period 1
11066467|NCT01392469|OG001|Outcome|Imatinib (200 mg/Day) + Bosentan + Sildenafil|Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg tablet daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2.
11035819|NCT01230502|OG002|Outcome|Group 1 DSR (+), Withdrawal of Tacrolimus to MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
11035820|NCT01230502|OG000|Outcome|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
11035821|NCT01230502|OG001|Outcome|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
11035822|NCT01230502|OG002|Outcome|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
11066468|NCT01392469|OG002|Outcome|Imatinib (400 mg/Day) + Bosentan+ Sildenafil|Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg tablet daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.
11225940|NCT02370784|FG001|Participant Flow|Placebo Control|Placebo: oral drug of similar appearance to atorvastatin
11225941|NCT02370784|OG000|Outcome|Active Drug|"atorvastatin 40 mg once daily for sixteen weeks~atorvastatin: Atorvastatin is an oral cholesterol-lowering medication commonly referred to as statin therapy."
11225942|NCT02370784|OG001|Outcome|Placebo Control|"receive a placebo of similar appearance once daily for sixteen weeks~Placebo: oral drug of similar appearance to atorvastatin"
11225943|NCT02370784|OG000|Outcome|Atorvastatin 40 mg Daily|Atorvastatin 40 mg daily x 16 weeks
11225944|NCT02370784|OG001|Outcome|Placebo|Placebo daily x 16 weeks
11225945|NCT02370784|EG000|Reported Event|Atorvastatin 40 mg Daily|Length of intervention: 16 weeks atorvastatin: Atorvastatin is an oral cholesterol-lowering medication commonly referred to as statin therapy.
11225946|NCT02370784|EG001|Reported Event|Placebo Control|Placebo: oral drug of similar appearance to atorvastatin
11225947|NCT02370810|BG000|Baseline|Experimental Group|"CBT-based internet-intervention for tinnitus The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.~CBT-based internet-intervention for tinnitus: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt."
11225948|NCT02370810|BG001|Baseline|Weekly check-in Group|will complete weekly measures and commence the treatment once the experimental group completes the intervention
11225949|NCT02370810|BG002|Baseline|Total|Total of all reporting groups
11225950|NCT02370810|FG000|Participant Flow|Experimental Group|CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
11225951|NCT02370810|FG001|Participant Flow|Control Group|During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
11225952|NCT02370810|OG000|Outcome|Experimental Group|CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
11225953|NCT02370810|OG001|Outcome|Control Group|During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
11035823|NCT01230502|EG000|Reported Event|Group 3: DSR (Donor Specific Regulation) (-), Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR(-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
11035824|NCT01230502|EG001|Reported Event|Group 2 DSR (Donor Specific Regulation) (+); Standard of Care|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR(+) standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
11035825|NCT01230502|EG002|Reported Event|Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy|"Subjects that are Donor specific regulation DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
11035826|NCT01230554|BG000|Baseline|Prism I|"Bausch & Lomb daily disposable cosmetic tint contact lens~Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week."
11035827|NCT01230554|FG000|Participant Flow|Prism I|"Bausch & Lomb daily disposable cosmetic tint contact lens~Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week."
11035828|NCT01230554|OG000|Outcome|Prism I|"Bausch & Lomb daily disposable cosmetic tint contact lens~Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week."
11035829|NCT01230554|EG000|Reported Event|Prism I|"Bausch & Lomb daily disposable cosmetic tint contact lens~Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week."
11035830|NCT01230593|BG000|Baseline|Hot Compress|"Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.~Hot Compresses: Hot compresses 3x/day to eyelids"
11035831|NCT01230593|BG001|Baseline|Hot Compress + Tobramycin Drops and Ointment|"In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.~Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed."
11035832|NCT01230593|BG002|Baseline|Hot Compress + Tobramycin/Dexamethasone Drops and Ointment|"In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.~Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed."
11035833|NCT01230593|BG003|Baseline|Total|Total of all reporting groups
11035834|NCT01230593|FG000|Participant Flow|Hot Compress|"Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.~Hot Compresses: Hot compresses 3x/day to eyelids"
11035835|NCT01230593|FG001|Participant Flow|Hot Compress + Tobramycin Drops and Ointment|"In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.~Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed."
11035836|NCT01230593|FG002|Participant Flow|Hot Compress + Tobramycin/Dexamethasone Drops and Ointment|"In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.~Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed."
11035837|NCT01230593|OG000|Outcome|Hot Compress|"Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.~Hot Compresses: Hot compresses 3x/day to eyelids"
11035838|NCT01230593|OG001|Outcome|Hot Compress + Tobramycin Drops and Ointment|"In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.~Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed."
11035839|NCT01230593|OG002|Outcome|Hot Compress + Tobramycin/Dexamethasone Drops and Ointment|"In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.~Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed."
11035840|NCT01230593|EG000|Reported Event|Hot Compress|"Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.~Hot Compresses: Hot compresses 3x/day to eyelids"
11035841|NCT01230593|EG001|Reported Event|Hot Compress, Tobrex Drops, Tobrex Ointment|"In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.~Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed."
11035842|NCT01230593|EG002|Reported Event|Hot Compress, Tobradex Drops, Tobradex Ointment|"In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.~Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed."
11035843|NCT01230710|BG000|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
11035844|NCT01230710|FG000|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
11035845|NCT01230710|OG000|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
11035846|NCT01230710|EG000|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
11035847|NCT01230749|BG000|Baseline|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
11035848|NCT01230749|BG001|Baseline|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
11035849|NCT01230749|BG002|Baseline|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
11035850|NCT01230749|BG003|Baseline|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
11035851|NCT01230749|BG004|Baseline|Total|Total of all reporting groups
11035852|NCT01230749|FG000|Participant Flow|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
11035853|NCT01230749|FG001|Participant Flow|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
11035854|NCT01230749|FG002|Participant Flow|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
11035855|NCT01230749|FG003|Participant Flow|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
11035856|NCT01230749|OG000|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
11035857|NCT01230749|OG001|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
11035858|NCT01230749|OG002|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
11035859|NCT01230749|OG003|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
11035860|NCT01230749|OG000|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
11035861|NCT01230749|OG001|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
11035862|NCT01230749|OG002|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
11035863|NCT01230749|EG000|Reported Event|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
11035864|NCT01230749|EG001|Reported Event|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
11035865|NCT01230749|EG002|Reported Event|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
11035866|NCT01230749|EG003|Reported Event|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
11035867|NCT01230801|BG000|Baseline|BMN 701 5 mg/kg|BMN 701 5 mg/kg IV
11035868|NCT01230801|BG001|Baseline|BMN 701 10 mg/kg|BMN 701 10 mg/kg IV
11035869|NCT01230801|BG002|Baseline|BMN 701 20 mg/kg|BMN 701 20 mg/kg IV
11035870|NCT01230801|BG003|Baseline|Total|Total of all reporting groups
11035871|NCT01230801|FG000|Participant Flow|BMN 701 5 mg/kg|BMN 701 5 mg/kg IV
11035872|NCT01230801|FG001|Participant Flow|BMN 701 10 mg/kg|BMN 701 10 mg/kg IV
11035873|NCT01230801|FG002|Participant Flow|BMN 701 20 mg/kg|BMN 701 20 mg/kg IV
11035874|NCT01230801|OG000|Outcome|BMN 701 5 mg/kg|BMN 701 5 mg/kg IV
11035875|NCT01230801|OG001|Outcome|BMN 701 10 mg/kg|BMN 701 10 mg/kg IV
11035876|NCT01230801|OG002|Outcome|BMN 701 20 mg/kg|BMN 701 20 mg/kg IV
11035877|NCT01230801|OG003|Outcome|Total|Total Results
11035878|NCT01230801|OG003|Outcome|Total|Total IV
11035879|NCT01230801|EG000|Reported Event|BMN 701 5 mg/kg|BMN 701 5 mg/kg IV
11035880|NCT01230801|EG001|Reported Event|BMN 701 10 mg/kg|BMN 701 10 mg/kg IV
11035881|NCT01230801|EG002|Reported Event|BMN 701 20 mg/kg|BMN 701 20 mg/kg IV
11035882|NCT01230801|EG003|Reported Event|Total|Total Results
11035883|NCT01230814|BG000|Baseline|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
11035884|NCT01230814|BG001|Baseline|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
11035885|NCT01230814|BG002|Baseline|Total|Total of all reporting groups
11035886|NCT01230814|FG000|Participant Flow|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
11035887|NCT01230814|FG001|Participant Flow|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
11035888|NCT01230814|OG000|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
11225954|NCT02370810|OG000|Outcome|Experimental Group|"CBT-based internet-intervention for tinnitus The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.~CBT-based internet-intervention for tinnitus: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt."
11225955|NCT02370810|OG001|Outcome|Weekly check-in Group|will complete weekly measures and commence the treatment once the experimental group completes the intervention
11225956|NCT02370810|EG000|Reported Event|Experimental Group|CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
11225957|NCT02370810|EG001|Reported Event|Control Group|During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
11225958|NCT02370914|BG000|Baseline|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
11225959|NCT02370914|FG000|Participant Flow|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
11035889|NCT01230814|OG001|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
11035890|NCT01230814|EG000|Reported Event|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
11035891|NCT01230814|EG001|Reported Event|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
11035892|NCT01230827|BG000|Baseline|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
11035893|NCT01230827|BG001|Baseline|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
11035894|NCT01230827|BG002|Baseline|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
11035895|NCT01230827|BG003|Baseline|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
11035896|NCT01230827|BG004|Baseline|Total|Total of all reporting groups
11035897|NCT01230827|FG000|Participant Flow|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
11035898|NCT01230827|FG001|Participant Flow|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
11035899|NCT01230827|FG002|Participant Flow|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
11035900|NCT01230827|FG003|Participant Flow|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
11066469|NCT01392469|OG000|Outcome|Imatinib (200 mg/Day) + Bosentan + Sildenafil|Participants received concomitant treatment of oral imatinib 200 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2.
11225960|NCT02370914|OG000|Outcome|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
11225961|NCT02370914|EG000|Reported Event|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
11225962|NCT02371187|BG000|Baseline|Dapagliflozin|"The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days."
11225963|NCT02371187|BG001|Baseline|Placebo|"Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days."
11225964|NCT02371187|BG002|Baseline|Total|Total of all reporting groups
11035901|NCT01230827|OG000|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
11035902|NCT01230827|OG001|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
11035903|NCT01230827|EG000|Reported Event|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
11035904|NCT01230827|EG001|Reported Event|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
11035905|NCT01230827|EG002|Reported Event|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
11035906|NCT01230827|EG003|Reported Event|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
11035907|NCT01230892|BG000|Baseline|Nebivolol|Nebivolol: 10 mg PO qday
11035908|NCT01230892|BG001|Baseline|Atenolol|Atenolol: 100 mg PO qday
11035909|NCT01230892|BG002|Baseline|Total|Total of all reporting groups
11035910|NCT01230892|FG000|Participant Flow|Nebivolol|Nebivolol: 10 mg PO qday
11035911|NCT01230892|FG001|Participant Flow|Atenolol|Atenolol: 100 mg PO qday
11035912|NCT01230892|OG000|Outcome|Nebivolol|Nebivolol: 10 mg PO qday
11035913|NCT01230892|OG001|Outcome|Atenolol|Atenolol: 100 mg PO qday
11035914|NCT01230892|EG000|Reported Event|Nebivolol|Nebivolol: 10 mg PO qday
11225965|NCT02371187|FG000|Participant Flow|Dapagliflozin|"The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days."
11035915|NCT01230892|EG001|Reported Event|Atenolol|Atenolol: 100 mg PO qday
11035916|NCT01230931|BG000|Baseline|Vitagel and Standard of Care|"The group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.~Vitagel: Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11035917|NCT01230931|BG001|Baseline|Standard of Care|"This group of patients will receive the standard of care for hemostasis in acetabular surgery (electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing). They will not receive the vitagel product.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11035918|NCT01230931|BG002|Baseline|Total|Total of all reporting groups
11035919|NCT01230931|FG000|Participant Flow|Vitagel and Standard of Care|"The group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.~Vitagel: Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11035920|NCT01230931|FG001|Participant Flow|Standard of Care|"This group of patients will receive the standard of care for hemostasis in acetabular surgery (electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing). They will not receive the vitagel product.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11035921|NCT01230931|OG000|Outcome|Vitagel and Standard of Care|"The group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.~Vitagel: Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11225966|NCT02371187|FG001|Participant Flow|Placebo|"Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days."
11035922|NCT01230931|OG001|Outcome|Standard of Care|"This group of patients will receive the standard of care for hemostasis in acetabular surgery (electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing). They will not receive the vitagel product.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11035923|NCT01230931|OG000|Outcome|Vitagel and Standard of Care|"This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.~Vitagel: Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11035924|NCT01230931|EG000|Reported Event|Vitagel and Standard of Care|"The group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.~Vitagel: Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11035925|NCT01230931|EG001|Reported Event|Standard of Care|"This group of patients will receive the standard of care for hemostasis in acetabular surgery (electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing). They will not receive the vitagel product.~Standard of care: Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing."
11035926|NCT01231230|BG000|Baseline|All Study Participants|participant received in random order one of the four treatments ( fluticasone, salmeterol, fluticasone+salmeterol or placebo)
11035927|NCT01231230|FG000|Participant Flow|All Study Groups|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
11225967|NCT02371187|OG000|Outcome|Dapagliflozin|"The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days."
11225968|NCT02371187|OG001|Outcome|Placebo|"Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days."
11225969|NCT02371187|EG000|Reported Event|Dapagliflozin|"The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days."
11225970|NCT02371187|EG001|Reported Event|Placebo|"Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days."
11225971|NCT02371252|BG000|Baseline|Original Alendronate (Fosamax)|The patients will be given the brand alendronate (Fosamax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
11225972|NCT02371252|BG001|Baseline|Generic Alendronate (Bonmax)|"The patients will be given the generic alendronate (Bonmax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.~Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment."
11225973|NCT02371252|BG002|Baseline|Total|Total of all reporting groups
11035928|NCT01231230|OG000|Outcome|Fluticasone|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
11035929|NCT01231230|OG001|Outcome|Placebo|"inhalation of placebo diskus~placebo inhalation: placebo inhalation once"
11035930|NCT01231230|OG002|Outcome|Salmeterol|"inhalation of salmeterol 50 mcg once~Salmeterol: 50 mcg salmeterol once~Salmeterol: 50 mcg once"
11225974|NCT02371252|FG000|Participant Flow|Original Alendronate (Fosamax)|The patients will be given the brand alendronate (Fosamax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
11225975|NCT02371252|FG001|Participant Flow|Generic Alendronate (Bonmax)|"The patients will be given the generic alendronate (Bonmax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.~Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment."
11225976|NCT02371252|OG000|Outcome|Original Alendronate (Fosamax)|The patients will be given the brand alendronate (Fosamax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
11225977|NCT02371252|OG001|Outcome|Generic Alendronate (Bonmax)|"The patients will be given the generic alendronate (Bonmax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.~Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment."
11035931|NCT01231230|OG003|Outcome|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg~fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
11035932|NCT01231230|EG000|Reported Event|Fluticasone|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
11035933|NCT01231230|EG001|Reported Event|Placebo|"inhalation of placebo diskus~placebo inhalation: placebo inhalation once"
11035934|NCT01231230|EG002|Reported Event|Salmeterol|"inhalation of salmeterol 50 mcg once~Salmeterol: 50 mcg salmeterol once~Salmeterol: 50 mcg once"
11035935|NCT01231230|EG003|Reported Event|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg~fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
11035936|NCT01231321|BG000|Baseline|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
11035937|NCT01231321|FG000|Participant Flow|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
11035938|NCT01231321|OG000|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
11035939|NCT01231321|OG000|Outcome|Change From Normal to Abnormal|Subjects whose physical examination findings for the categories below were normal at Baseline and abnormal at 24 weeks
11035940|NCT01231321|OG001|Outcome|Change From Abnormal to Normal|Subjects whose physical examination findings for the categories below were abnormal at Baseline and normal at 24 weeks
11035941|NCT01231321|OG000|Outcome|Below Reference Range|Subjects with laboratory values at Week 24 lower than the reference range indicated for each parameter
11035942|NCT01231321|OG001|Outcome|Above Reference Range|Subjects with laboratory values at Week 24 higher than the reference range indicated for each parameter
11035943|NCT01231321|OG000|Outcome|Below Reference Range|Subjects with vital sign values at Week 24 lower than the reference range indicated for each parameter
11035944|NCT01231321|OG001|Outcome|Above Reference Range|Subjects with vital sign values at Week 24 higher than the reference range indicated for each parameter
11035945|NCT01231321|EG000|Reported Event|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
11035946|NCT01231334|BG000|Baseline|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
11035947|NCT01231334|BG001|Baseline|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
11035948|NCT01231334|BG002|Baseline|Total|Total of all reporting groups
11035949|NCT01231334|FG000|Participant Flow|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
11035950|NCT01231334|FG001|Participant Flow|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
11225978|NCT02371252|EG000|Reported Event|Original Alendronate (Fosamax)|The patients will be given the brand alendronate (Fosamax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
11035951|NCT01231334|OG000|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
11035952|NCT01231334|OG001|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
11035953|NCT01231334|EG000|Reported Event|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
11225979|NCT02371252|EG001|Reported Event|Generic Alendronate (Bonmax)|The patients will be given the generic alendronate (Bonmax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
11225980|NCT02371356|BG000|Baseline|Depressed, Medication Only|Screen positive for depression and use only antidepressants during pregnancy
11035954|NCT01231334|EG001|Reported Event|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
11035955|NCT01231373|BG000|Baseline|Vehicle|Vehicle: Injection of vehicle comparator
11035956|NCT01231373|BG001|Baseline|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam active placebo
11035957|NCT01231373|BG002|Baseline|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam lower experimental dose
11035958|NCT01231373|BG003|Baseline|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam therapeutic dose
11035959|NCT01231373|BG004|Baseline|Total|Total of all reporting groups
11035960|NCT01231373|FG000|Participant Flow|Vehicle|Vehicle: Injection of vehicle comparator
11035961|NCT01231373|FG001|Participant Flow|Polidocanol Injectable Foam, 0.125%|active placebo for blinding of therapeutic polidocanol dose
11035962|NCT01231373|FG002|Participant Flow|Polidocanol Injectable Foam, 0.5%|lower experimental polidocanol dose
11035963|NCT01231373|FG003|Participant Flow|Polidocanol Injectable Foam, 1.0%|1.0% polidocanol foam injection
11035964|NCT01231373|OG000|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
11035965|NCT01231373|OG001|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
11035966|NCT01231373|OG002|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
11035967|NCT01231373|OG003|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0%: Injection of mid-dose PEM
11035968|NCT01231373|OG003|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, experimental dose 1.0%
11035969|NCT01231373|OG003|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0% experimental dose
11035970|NCT01231373|EG000|Reported Event|Vehicle|Vehicle: Injection of vehicle comparator
11035971|NCT01231373|EG001|Reported Event|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125% active placebo
11035972|NCT01231373|EG002|Reported Event|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam, 0.5% lower experimental dose
11035973|NCT01231373|EG003|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam target therapeutic dose
11035974|NCT01231399|BG000|Baseline|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
11035975|NCT01231399|FG000|Participant Flow|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
11035976|NCT01231399|OG000|Outcome|Dose Level 1 - 2.5 mg Everolimus|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
11035977|NCT01231399|OG000|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
11225981|NCT02371356|BG001|Baseline|Depressed, Psychotherapy Only|Screen positive for depression and receive psychotherapy only
11225982|NCT02371356|BG002|Baseline|Depressed, Medication & Psychotherapy|Screen positive for depression and receive both antidepressants and psychotherapy
11225983|NCT02371356|BG003|Baseline|Depressed, Untreated|Screen positive for depression and receive no treatment
11225984|NCT02371356|BG004|Baseline|Not Depressed|Screen negative for depression and received no treatment
11225985|NCT02371356|BG005|Baseline|Total|Total of all reporting groups
11225986|NCT02371356|FG000|Participant Flow|Depressed, Medication Only|Screen positive for depression and use only antidepressants during pregnancy
11225987|NCT02371356|FG001|Participant Flow|Depressed, Psychotherapy Only|Screen positive for depression and receive psychotherapy only
11225988|NCT02371356|FG002|Participant Flow|Depressed, Medication & Psychotherapy|Screen positive for depression and receive both antidepressants and psychotherapy
11225989|NCT02371356|FG003|Participant Flow|Depressed, Untreated|Screen positive for depression and receive no treatment
11225990|NCT02371356|FG004|Participant Flow|Not Depressed|Screen negative for depression and received no treatment
11035978|NCT01231399|EG000|Reported Event|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
11035979|NCT01231412|BG000|Baseline|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
11035980|NCT01231412|BG001|Baseline|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
11035981|NCT01231412|BG002|Baseline|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
11035982|NCT01231412|BG003|Baseline|Total|Total of all reporting groups
11066470|NCT01392469|OG001|Outcome|Imatinib (400 mg/Day) + Bosentan + Sildenafil|Participants received concomitant treatment of oral imatinib 400 mg tablet daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.
11225991|NCT02371356|OG000|Outcome|Depressed, Medication Only|Screen positive for depression and use only antidepressants during pregnancy
11225992|NCT02371356|OG001|Outcome|Depressed, Psychotherapy Only|Screen positive for depression and receive psychotherapy only
11225993|NCT02371356|OG002|Outcome|Depressed, Medication & Psychotherapy|Screen positive for depression and receive both antidepressants and psychotherapy
11225994|NCT02371356|OG003|Outcome|Depressed, Untreated|Screen positive for depression and receive no treatment
11225995|NCT02371356|OG004|Outcome|Not Depressed|Screen negative for depression and received no treatment
11035983|NCT01231412|FG000|Participant Flow|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
11035984|NCT01231412|FG001|Participant Flow|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
11035985|NCT01231412|FG002|Participant Flow|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
11035986|NCT01231412|OG000|Outcome|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
11035987|NCT01231412|OG001|Outcome|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
11035988|NCT01231412|OG002|Outcome|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
11035989|NCT01231412|EG000|Reported Event|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
11035990|NCT01231412|EG001|Reported Event|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
11035991|NCT01231412|EG002|Reported Event|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
11035992|NCT01231464|BG000|Baseline|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
11035993|NCT01231464|BG001|Baseline|Placebo|Matching Vehicle Placebo Nasal Spray QD
11035994|NCT01231464|BG002|Baseline|Total|Total of all reporting groups
11035995|NCT01231464|FG000|Participant Flow|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
11035996|NCT01231464|FG001|Participant Flow|Placebo|Matching Vehicle Placebo Nasal Spray QD
11035997|NCT01231464|OG000|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
11035998|NCT01231464|OG001|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
11035999|NCT01231464|OG001|Outcome|Placebo|Matching Vehicle placebo nasal spray QD
11036000|NCT01231464|OG000|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mg) once daily (QD)
11036001|NCT01231464|EG000|Reported Event|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
11036002|NCT01231464|EG001|Reported Event|Placebo|Matching Vehicle Placebo Nasal Spray QD
11036003|NCT01231503|BG000|Baseline|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11066471|NCT01392469|EG000|Reported Event|Bosentan + Sildenafil|Participants received treatment with bosentan 125 mg twice daily and sildenafil thrice daily for 8 days in treatment period 1
11066472|NCT01392469|EG001|Reported Event|Imatinib (200 mg/Day) + Bosentan + Sildenafil|Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg tablet daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2.
11225996|NCT02371356|EG000|Reported Event|Depressed, Medication Only|Screen positive for depression and use only antidepressants during pregnancy
11036004|NCT01231503|BG001|Baseline|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036005|NCT01231503|BG002|Baseline|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036006|NCT01231503|BG003|Baseline|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036007|NCT01231503|BG004|Baseline|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036008|NCT01231503|BG005|Baseline|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of TritanrixHepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036009|NCT01231503|BG006|Baseline|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036010|NCT01231503|BG007|Baseline|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036011|NCT01231503|BG008|Baseline|Total|Total of all reporting groups
11036012|NCT01231503|FG000|Participant Flow|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11066473|NCT01392469|EG002|Reported Event|Imatinib (400 mg/Day) + Bosentan+ Sildenafil|Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg tablet daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.
11066474|NCT01392469|EG003|Reported Event|Total Participants|
11066475|NCT01392495|BG000|Baseline|QTI571|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
11066476|NCT01392495|FG000|Participant Flow|QTI571|Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
11036013|NCT01231503|FG001|Participant Flow|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036014|NCT01231503|FG002|Participant Flow|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036015|NCT01231503|FG003|Participant Flow|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036016|NCT01231503|FG004|Participant Flow|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036017|NCT01231503|FG005|Participant Flow|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036018|NCT01231503|FG006|Participant Flow|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036019|NCT01231503|FG007|Participant Flow|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036020|NCT01231503|OG000|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11066477|NCT01392495|OG000|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
11066478|NCT01392495|OG001|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
11066479|NCT01392495|EG000|Reported Event|QTI571 200mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
11066480|NCT01392495|EG001|Reported Event|QTI571 400mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
11225997|NCT02371356|EG001|Reported Event|Depressed, Psychotherapy Only|Screen positive for depression and receive psychotherapy only
11036021|NCT01231503|OG001|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036022|NCT01231503|OG002|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036023|NCT01231503|OG003|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11066481|NCT01392547|BG000|Baseline|Vatrepcacog Alfa and rFVIIa|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner.
11066482|NCT01392547|FG000|Participant Flow|Vatreptacog Alfa and rFVIIa (All Subjects)|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner. Subjects participating in the trial had bleeding episodes randomised to treatment with either vatraptacog alfa or rFVIIa in an independent manner for each bleeding episodes. Of the 72 subjects, 3 subjects did not have any bleeds.
11225998|NCT02371356|EG002|Reported Event|Depressed, Medication & Psychotherapy|Screen positive for depression and receive both antidepressants and psychotherapy
11225999|NCT02371356|EG003|Reported Event|Depressed, Untreated|Screen positive for depression and receive no treatment
11226000|NCT02371356|EG004|Reported Event|Not Depressed|Screen negative for depression and received no treatment
11226001|NCT02371395|BG000|Baseline|Single Arm|This was a study of enrolling patients with fever or history of fever for malaria testing. A total of 1,000 samples were collected from patients in Cruzeiro do Sul, Acre state from January to June, 2015.
11226002|NCT02371395|FG000|Participant Flow|Patients With Suspected Malaria (Fever)|This was a study of enrolling patients with fever or history of fever for malaria testing. A total of 1,000 samples were collected from patients in Cruzeiro do Sul, Acre state from January to June, 2015.
11226003|NCT02371395|OG000|Outcome|Single Arm|This was a study of enrolling patients with fever or history of fever for malaria testing. A total of 1,000 samples were collected from patients in Cruzeiro do Sul, Acre state from January to June, 2015.
11226004|NCT02371395|EG000|Reported Event|Single Arm|This was a study of enrolling patients with fever or history of fever for malaria testing. A total of 1,000 samples were collected from patients in Cruzeiro do Sul, Acre state from January to June, 2015.
11226005|NCT02371616|BG000|Baseline|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
11226006|NCT02371616|BG001|Baseline|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
11226007|NCT02371616|BG002|Baseline|Total|Total of all reporting groups
11226008|NCT02371616|FG000|Participant Flow|Test Dentifrice|Test dentifrice containing 5% weight by weight (w/w) calcium sodium phosphosilicate and 1426 parts per million (ppm) fluoride as sodium fluoride.
11226009|NCT02371616|FG001|Participant Flow|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
11226010|NCT02371616|OG000|Outcome|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
11226011|NCT02371616|OG001|Outcome|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
11226012|NCT02371616|EG000|Reported Event|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
11226013|NCT02371616|EG001|Reported Event|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
11226014|NCT02371629|BG000|Baseline|NVA237 Twice Daily|Patients randomized to this arm received an NVA237 22 μg capsule in the morning and evening for 26 weeks. All participants received salbutamol as rescue medicine.
11226015|NCT02371629|BG001|Baseline|NVA237 Once Daily|Patients randomized to this arm received an NVA237 44 μg capsule in the morning and a placebo capsule in the evening for 26 weeks. All participants received salbutamol as rescue medicine.
11226016|NCT02371629|BG002|Baseline|Total|Total of all reporting groups
11226017|NCT02371629|FG000|Participant Flow|NVA237 Twice Daily|Patients randomized to this arm received an NVA237 22 μg capsule in the morning and evening for 26 weeks. All participants received salbutamol as rescue medicine.
11226018|NCT02371629|FG001|Participant Flow|NVA237 Once Daily|Patients randomized to this arm received an NVA237 44 μg capsule in the morning and a placebo capsule in the evening for 26 weeks. All participants received salbutamol as rescue medicine.
11226019|NCT02371629|OG000|Outcome|NVA237 Twice Daily|Patients randomized to this arm received an NVA237 22 μg capsule in the morning and evening for 26 weeks. All participants received salbutamol as rescue medicine.
11036024|NCT01231503|OG004|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036025|NCT01231503|OG005|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036026|NCT01231503|OG006|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036027|NCT01231503|OG007|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036028|NCT01231503|OG001|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036029|NCT01231503|OG002|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036030|NCT01231503|OG000|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036031|NCT01231503|OG001|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11066483|NCT01392547|OG000|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1-3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
11066484|NCT01392547|OG001|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1-3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
11226020|NCT02371629|OG001|Outcome|NVA237 Once Daily|Patients randomized to this arm received an NVA237 44 μg capsule in the morning and a placebo capsule in the evening for 26 weeks. All participants received salbutamol as rescue medicine.
11226021|NCT02371629|EG000|Reported Event|NVA237 22 mcg b.i.d.|NVA237 22 mcg b.i.d.
11226022|NCT02371629|EG001|Reported Event|NVA237 44 mcg o.d.|NVA237 44 mcg o.d.
11036032|NCT01231503|OG002|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036033|NCT01231503|OG003|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036034|NCT01231503|OG000|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036035|NCT01231503|OG001|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036036|NCT01231503|OG005|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036037|NCT01231503|OG004|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036038|NCT01231503|EG000|Reported Event|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11226023|NCT02371668|BG000|Baseline|CR6261|CR6261, Investigational monoclonal antibody against influenza A viruses
11036039|NCT01231503|EG001|Reported Event|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11066485|NCT01392547|EG000|Reported Event|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1-3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
11066486|NCT01392547|EG001|Reported Event|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1-3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
11226024|NCT02371668|BG001|Baseline|Placebo Comparator|Placebo, 5% dextrose (D-glucose) water
11226025|NCT02371668|BG002|Baseline|Total|Total of all reporting groups
11036040|NCT01231503|EG002|Reported Event|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036041|NCT01231503|EG003|Reported Event|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036042|NCT01231503|EG004|Reported Event|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036043|NCT01231503|EG005|Reported Event|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036044|NCT01231503|EG006|Reported Event|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036045|NCT01231503|EG007|Reported Event|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
11036046|NCT01231555|BG000|Baseline|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036047|NCT01231555|BG001|Baseline|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036048|NCT01231555|BG002|Baseline|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036049|NCT01231555|BG003|Baseline|Total|Total of all reporting groups
11036050|NCT01231555|FG000|Participant Flow|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 milligrams (mg) capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 mg once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received antiretroviral therapy (ART) of Tenofovir disoproxil fumarate/ Emtricitabine (TDF/FTC) 300 mg/200 mg or Abacavir/ Lamivudine (ABC/3TC) 600 mg/300 mg along with the study drug.
11036051|NCT01231555|FG001|Participant Flow|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11066487|NCT01392560|BG000|Baseline|Empagliflozin (BI 10773) 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
11036052|NCT01231555|FG002|Participant Flow|EFV 600 mg Once Daily|Eligible participants were planned to receive oral Efavirenz (EFV) 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036053|NCT01231555|OG000|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036054|NCT01231555|OG001|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036055|NCT01231555|OG002|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036056|NCT01231555|EG000|Reported Event|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036057|NCT01231555|EG001|Reported Event|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036058|NCT01231555|EG002|Reported Event|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
11036059|NCT01231581|BG000|Baseline|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
11036060|NCT01231581|BG001|Baseline|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
11036061|NCT01231581|BG002|Baseline|Total|Total of all reporting groups
11036062|NCT01231581|FG000|Participant Flow|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
11036063|NCT01231581|FG001|Participant Flow|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
11036064|NCT01231581|OG000|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
11036065|NCT01231581|OG001|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
11036066|NCT01231581|EG000|Reported Event|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
11036067|NCT01231581|EG001|Reported Event|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
11036068|NCT01231607|BG000|Baseline|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
11036069|NCT01231607|BG001|Baseline|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
11036070|NCT01231607|BG002|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
11226026|NCT02371668|FG000|Participant Flow|CR6261|CR6261, Investigational monoclonal antibody against influenza A viruses
11226027|NCT02371668|FG001|Participant Flow|Placebo Comparator|Placebo, 5% dextrose (D-glucose) water
11226028|NCT02371668|OG000|Outcome|CR6261|CR6261, Investigational monoclonal antibody against influenza A viruses
11226029|NCT02371668|OG001|Outcome|Placebo Comparator|Placebo, 5% dextrose (D-glucose) water
11226030|NCT02371668|EG000|Reported Event|CR6261|CR6261, Investigational monoclonal antibody against influenza A viruses
11226031|NCT02371668|EG001|Reported Event|Placebo Comparator|Placebo, 5% dextrose (D-glucose) water
11226032|NCT02371746|BG000|Baseline|Cohort 1 - Group 1|2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
11036071|NCT01231607|BG003|Baseline|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
11036072|NCT01231607|BG004|Baseline|Placebo|Matching dutasteride placebo and finasteride placebo once daily
11036073|NCT01231607|BG005|Baseline|Total|Total of all reporting groups
11036074|NCT01231607|FG000|Participant Flow|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
11036075|NCT01231607|FG001|Participant Flow|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
11036076|NCT01231607|FG002|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
11036077|NCT01231607|FG003|Participant Flow|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
11036078|NCT01231607|FG004|Participant Flow|Placebo|Matching dutasteride placebo and finasteride placebo once daily
11036079|NCT01231607|OG000|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
11036080|NCT01231607|OG001|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
11036081|NCT01231607|OG002|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
11036082|NCT01231607|OG003|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
11226033|NCT02371746|BG001|Baseline|Cohort 1 - Group 2|3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
11226034|NCT02371746|BG002|Baseline|Cohort 1 - Group 3|1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
11226035|NCT02371746|BG003|Baseline|Cohort 1 - Group 4|2 ENV515-3 implants (85.0 μg travoprost) in Study Eye for 28 days
11226036|NCT02371746|BG004|Baseline|Cohort 2|2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
11226037|NCT02371746|BG005|Baseline|Cohort 3 - Group 1|1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
11226038|NCT02371746|BG006|Baseline|Cohort 3 - Group 2|2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
11226039|NCT02371746|BG007|Baseline|Total|Total of all reporting groups
11226040|NCT02371746|FG000|Participant Flow|Cohort 1 - Group 1|2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
11226041|NCT02371746|FG001|Participant Flow|Cohort 1 - Group 2|3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
11226042|NCT02371746|FG002|Participant Flow|Cohort 1 - Group 3|1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
11226043|NCT02371746|FG003|Participant Flow|Cohort 1 - Group 4|2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days
11226044|NCT02371746|FG004|Participant Flow|Cohort 2|2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
11226045|NCT02371746|FG005|Participant Flow|Cohort 3 - Group 1|1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
11226046|NCT02371746|FG006|Participant Flow|Cohort 3 - Group 2|2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
11226047|NCT02371746|OG000|Outcome|Cohort 1 - Group 1|2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
11226048|NCT02371746|OG001|Outcome|Cohort 1 - Group 2|3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
11226049|NCT02371746|OG002|Outcome|Cohort 1 - Group 3|1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
11226050|NCT02371746|OG003|Outcome|Cohort 1 - Group 4|2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days
11226051|NCT02371746|OG004|Outcome|Cohort 2|2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
11226052|NCT02371746|OG005|Outcome|Cohort 3 - Group 1|1 ENV515-3-2 implant (28.2 μg travoprost) in Study Eye for for up to 24 months
11226053|NCT02371746|OG006|Outcome|Cohort 3 - Group 2|2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
11226054|NCT02371746|EG000|Reported Event|Cohort 1 - Group 1|2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
11226055|NCT02371746|EG001|Reported Event|Cohort 1 - Group 2|3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
11226056|NCT02371746|EG002|Reported Event|Cohort 2 - Group 3|1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
11226057|NCT02371746|EG003|Reported Event|Cohort 1 - Group 4|2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days
11226058|NCT02371746|EG004|Reported Event|Cohort 2|2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
11226059|NCT02371746|EG005|Reported Event|Cohort 3 - Group 1|1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
11226060|NCT02371746|EG006|Reported Event|Cohort 3 - Group 2|2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
11226061|NCT02371759|BG000|Baseline|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226062|NCT02371759|BG001|Baseline|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11036083|NCT01231607|OG004|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
11226063|NCT02371759|BG002|Baseline|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226064|NCT02371759|BG003|Baseline|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226065|NCT02371759|BG004|Baseline|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226066|NCT02371759|BG005|Baseline|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226067|NCT02371759|BG006|Baseline|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226068|NCT02371759|BG007|Baseline|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226069|NCT02371759|BG008|Baseline|Total|Total of all reporting groups
11226070|NCT02371759|FG000|Participant Flow|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226071|NCT02371759|FG001|Participant Flow|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11036084|NCT01231607|OG000|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
11036085|NCT01231607|OG001|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
11036086|NCT01231607|OG002|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
11036087|NCT01231607|EG000|Reported Event|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
11226072|NCT02371759|FG002|Participant Flow|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226073|NCT02371759|FG003|Participant Flow|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226074|NCT02371759|FG004|Participant Flow|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226075|NCT02371759|FG005|Participant Flow|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226076|NCT02371759|FG006|Participant Flow|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226077|NCT02371759|FG007|Participant Flow|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226078|NCT02371759|OG000|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226079|NCT02371759|OG001|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226080|NCT02371759|OG002|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226081|NCT02371759|OG003|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226082|NCT02371759|OG004|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226083|NCT02371759|OG005|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226084|NCT02371759|OG006|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226085|NCT02371759|OG007|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226086|NCT02371759|EG000|Reported Event|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226087|NCT02371759|EG001|Reported Event|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226088|NCT02371759|EG002|Reported Event|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226089|NCT02371759|EG003|Reported Event|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226090|NCT02371759|EG004|Reported Event|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226091|NCT02371759|EG005|Reported Event|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
11226092|NCT02371759|EG006|Reported Event|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226093|NCT02371759|EG007|Reported Event|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
11226094|NCT02371785|BG000|Baseline|Baseline Demographics|Baseline measures for the treated subjects.
11226095|NCT02371785|FG000|Participant Flow|CorPath 200 System|"CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention.~CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI)."
11226096|NCT02371785|OG000|Outcome|CorPath 200 System|"CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention.~CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI)."
11226097|NCT02371785|OG000|Outcome|Device-related Periprocedural Event|The primary safety measure was the absence of device-related serious adverse events during the procedure. These were defined as adverse events related to the use of the robotic device that resulted in hospitalization, prolonged hospitalization, were life threatening, or resulted in death.
11226098|NCT02371785|OG000|Outcome|Clinical Procedural Success|Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure (without an unplanned switch to the manual procedure) in the absence of device-related SAE, either within twenty-four (24) hours of the procedure or prior to hospital discharge, whichever occurs first.
11226099|NCT02371785|OG000|Outcome|Fluoroscopy and/or X-ray Time|As recorded by an X-ray system utilized during the procedure.
11226100|NCT02371785|OG000|Outcome|Contrast Fluid Volume|Total amount of contrast used during CorPath procedure.
11226101|NCT02371785|OG000|Outcome|Overall Procedure Time|Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).
11226102|NCT02371785|OG000|Outcome|PVI Procedure Time|Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
11226103|NCT02371785|EG000|Reported Event|Device-related Periprocedural Event|The primary safety measure was the absence of device-related serious adverse events during the procedure. These were defined as adverse events related to the use of the robotic device that resulted in hospitalization, prolonged hospitalization, were life threatening, or resulted in death.
11226104|NCT02371850|BG000|Baseline|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
11226105|NCT02371850|FG000|Participant Flow|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
11036088|NCT01231607|EG001|Reported Event|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
11226106|NCT02371850|OG000|Outcome|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
11226107|NCT02371850|OG000|Outcome|NicoDerm CQ (Early Heat)|early heat
11226108|NCT02371850|OG001|Outcome|NicoDerm CQ (Late Heat)|late heat
11226109|NCT02371850|OG002|Outcome|Aveva (Early Heat)|early heat
11226110|NCT02371850|OG003|Outcome|Aveva (Late Heat)|late heat
11226111|NCT02371850|EG000|Reported Event|Nicoderm Patch 4 h Heat Application|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
11036089|NCT01231607|EG002|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
11036090|NCT01231607|EG003|Reported Event|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
11036091|NCT01231607|EG004|Reported Event|Placebo|Matching dutasteride placebo and finasteride placebo once daily
11226112|NCT02371850|EG001|Reported Event|Nicoderm Patch 8 h Heat Application|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
11226113|NCT02371850|EG002|Reported Event|Aveva Patch 4 h Heat Application|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
11226114|NCT02371850|EG003|Reported Event|Aveva Patch 8 h Heat Application|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
11226115|NCT02371876|BG000|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11226116|NCT02371876|FG000|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11226117|NCT02371876|OG000|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
11036092|NCT01231620|BG000|Baseline|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.
11036093|NCT01231620|BG001|Baseline|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days
11036094|NCT01231620|BG002|Baseline|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.
11036095|NCT01231620|BG003|Baseline|Total|Total of all reporting groups
11036096|NCT01231620|FG000|Participant Flow|IV Zanamivir 300 mg|Participants >=16 years of age received intravenous (IV) zanamivir 300 milligrams (mg) twice daily, adjusted for renal function for 5-10 days.
11036097|NCT01231620|FG001|Participant Flow|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days
11036098|NCT01231620|FG002|Participant Flow|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.
11226118|NCT02371876|OG000|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary palm blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
10847134|NCT00281840|BG000|Baseline|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
11036099|NCT01231620|OG000|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.
11036100|NCT01231620|OG001|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days
11036101|NCT01231620|OG002|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.
11036102|NCT01231620|EG000|Reported Event|Intravenous (IV) Zanamivir 300mg Twice Daily|300mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily
11036103|NCT01231620|EG001|Reported Event|Intravenous (IV) Zanamivir 600mg Twice Daily|600mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily
11036104|NCT01231620|EG002|Reported Event|Oral Oseltamivir 75mg Twice Daily|75mg oral oseltamivir twice daily plus intravenous placebo zanamivir twice daily
11066488|NCT01392560|FG000|Participant Flow|Empagliflozin (BI 10773) 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
11036105|NCT01231633|BG000|Baseline|Group 1|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036106|NCT01231633|BG001|Baseline|Group 2|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036107|NCT01231633|BG002|Baseline|Total|Total of all reporting groups
11036108|NCT01231633|FG000|Participant Flow|Ozurdex & Avastin|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036109|NCT01231633|FG001|Participant Flow|Avastin Only|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036110|NCT01231633|OG000|Outcome|Group 1|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036111|NCT01231633|OG001|Outcome|Group 2|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036112|NCT01231633|OG000|Outcome|Ozurdex & Avastin|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036113|NCT01231633|OG001|Outcome|Avastin Only|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036114|NCT01231633|EG000|Reported Event|Group 1|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036115|NCT01231633|EG001|Reported Event|Group 2|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
11036116|NCT01231646|BG000|Baseline|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
11036117|NCT01231646|BG001|Baseline|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
11036118|NCT01231646|BG002|Baseline|Total|Total of all reporting groups
11036119|NCT01231646|FG000|Participant Flow|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
11036120|NCT01231646|FG001|Participant Flow|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
11036121|NCT01231646|OG000|Outcome|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
11036122|NCT01231646|OG001|Outcome|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
11036123|NCT01231646|EG000|Reported Event|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
11036124|NCT01231646|EG001|Reported Event|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
11066489|NCT01392560|OG000|Outcome|All Patients (Empagliflozin 25 mg)|"All patients (hyperfilterers and non-hyperfilterers)~Empagliflozin 25 mg: Oral once daily"
11066490|NCT01392560|OG001|Outcome|Hyperfilterers (Empagliflozin 25 mg)|"Hyperfilterers~Empagliflozin 25 mg: Oral once daily~hyperfilterers = GFRs of ≥135 mL/min/1.73m2"
11066491|NCT01392560|OG002|Outcome|Non-hyperfilterers (Empagliflozin 25 mg)|"Non-hyperfilterers~Empagliflozin 25 mg: Oral once daily~non-hyperfilterers = GFRs of ≥60 mL/min/1.73m2 to <135 mL/min/1.73m2"
11066492|NCT01392560|EG000|Reported Event|Empagliflozin 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
11066493|NCT01392573|BG000|Baseline|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
11066494|NCT01392573|BG001|Baseline|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11066495|NCT01392573|BG002|Baseline|Total|Total of all reporting groups
11066496|NCT01392573|FG000|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
11066497|NCT01392573|FG001|Participant Flow|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11036125|NCT01231659|BG000|Baseline|Everolimus + Letrozole|All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.
11036126|NCT01231659|FG000|Participant Flow|Everolimus + Letrozole|All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.
11036127|NCT01231659|OG000|Outcome|Everolimus + Letrozole|All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.
11036128|NCT01231659|EG000|Reported Event|Everolimus + Letrozole|All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.
11036129|NCT01231841|BG000|Baseline|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
11036130|NCT01231841|FG000|Participant Flow|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
11036131|NCT01231841|OG000|Outcome|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
11036132|NCT01231841|EG000|Reported Event|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
11036133|NCT01231984|BG000|Baseline|4 mm vs. 8 mm|Subjects randomized to this study arm first use either the 4mm PN or the 8mm PN for 12 weeks, then switched to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
11036134|NCT01231984|BG001|Baseline|4 mm vs. 12.7 mm|Subjects randomized to this study arm first use either the 4mm PN or the 12.7mm PN for 12 weeks, then switch to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
11036135|NCT01231984|BG002|Baseline|Total|Total of all reporting groups
11036136|NCT01231984|FG000|Participant Flow|4 mm First (4 vs.8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
11036137|NCT01231984|FG001|Participant Flow|8 mm First (4 vs.8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
11036138|NCT01231984|FG002|Participant Flow|4 mm First (4 vs.12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
11036139|NCT01231984|FG003|Participant Flow|12.7 mm First ( 4 vs.12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
11036140|NCT01231984|OG000|Outcome|4 mm First (4 vs. 8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
11036141|NCT01231984|OG001|Outcome|8 mm First (4 vs. 8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
11036142|NCT01231984|OG000|Outcome|4 mm First|Subjects in this group first used the 4 mm PN for 12 weeks in Period 1, then switched to a longer PN (8 mm or 12 mm PN) for another 12 weeks in Period 2, based on their randomization.
11036143|NCT01231984|OG001|Outcome|Longer PN First (8mm or 12.7mm)|Subjects in this group first used one of the longer PNs (8 mm or 12 mm PN) for 12 weeks in Period 1, based on the randomization, then switched to the 4mm PN for another 12 weeks in Period 2.
11036144|NCT01231984|OG000|Outcome|4 mm Among Those in 8mm x 4 mm Arm|Subjects randomized to this study arm first used the 8mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
11036145|NCT01231984|OG001|Outcome|8 mm Among Those in 4mm x 8mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 8mm PN for another 12 weeks.
11036146|NCT01231984|OG000|Outcome|4 mm Among Those in 12mm x 4mm Arm|Subjects randomized to this study arm first used the 12mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
11036147|NCT01231984|OG001|Outcome|12 mm Among Those in 4 mm x 12 mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 12mm PN for another 12 weeks.
11036148|NCT01231984|OG000|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
11036149|NCT01231984|OG001|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
11036150|NCT01231984|OG002|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
11036151|NCT01231984|OG000|Outcome|4 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
11036152|NCT01231984|OG001|Outcome|12.7 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
11036153|NCT01231984|EG000|Reported Event|4mm Needle|
11036154|NCT01231984|EG001|Reported Event|8mm Needle|
11036155|NCT01231984|EG002|Reported Event|12.7mm Needle|
11036156|NCT01232127|BG000|Baseline|All Treated|
11036157|NCT01232127|FG000|Participant Flow|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI). Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036158|NCT01232127|FG001|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036159|NCT01232127|FG002|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036160|NCT01232127|OG000|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036161|NCT01232127|OG001|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036162|NCT01232127|OG002|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036163|NCT01232127|OG000|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
11036164|NCT01232127|OG000|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI)on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036165|NCT01232127|OG001|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036166|NCT01232127|OG000|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus TDF, 300 mg QD, and at least 1 NRTI on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036167|NCT01232127|EG000|Reported Event|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036168|NCT01232127|EG001|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
11036169|NCT01232127|EG002|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF
11036170|NCT01232205|BG000|Baseline|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
11036171|NCT01232205|BG001|Baseline|Control|
11036172|NCT01232205|BG002|Baseline|Total|Total of all reporting groups
11036173|NCT01232205|FG000|Participant Flow|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
11036174|NCT01232205|FG001|Participant Flow|Control|
11036175|NCT01232205|OG000|Outcome|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
11036176|NCT01232205|OG001|Outcome|Control|
11036177|NCT01232205|EG000|Reported Event|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
11036178|NCT01232205|EG001|Reported Event|Control|
11036179|NCT01232296|BG000|Baseline|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
11036180|NCT01232296|BG001|Baseline|Sorafenib|400 mg tablet p.o. b.i.d.
11036181|NCT01232296|BG002|Baseline|Total|Total of all reporting groups
11036182|NCT01232296|FG000|Participant Flow|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
11036183|NCT01232296|FG001|Participant Flow|Sorafenib|400 mg tablet p.o. b.i.d.
11036184|NCT01232296|OG000|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
11036185|NCT01232296|OG001|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
11036186|NCT01232296|EG000|Reported Event|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
11036187|NCT01232296|EG001|Reported Event|Sorafenib|400 mg tablet p.o. b.i.d.
11036188|NCT01232452|BG000|Baseline|Pemetrexed + Cisplatin + Cixutumumab|"Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 plus cixutumumab 20 mg/kg given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.~Maintenance Therapy: Pemetrexed 500 mg/m^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met."
11036189|NCT01232452|BG001|Baseline|Pemetrexed + Cisplatin|"Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.~Maintenance Therapy: Pemetrexed 500 mg/m^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met."
11036190|NCT01232452|BG002|Baseline|Total|Total of all reporting groups
11036191|NCT01232452|FG000|Participant Flow|Pemetrexed + Cisplatin + Cixutumumab|"Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 plus cixutumumab 20 mg/kg given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.~Maintenance Therapy: Pemetrexed 500 mg/m^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met."
11036192|NCT01232452|FG001|Participant Flow|Pemetrexed + Cisplatin|"Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.~Maintenance Therapy: Pemetrexed 500 mg/m^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met."
11036193|NCT01232452|OG000|Outcome|Pemetrexed + Cisplatin + Cixutumumab|"Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 plus cixutumumab 20 mg/kg given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.~Maintenance Therapy: Pemetrexed 500 mg/m^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met."
11036194|NCT01232452|OG001|Outcome|Pemetrexed + Cisplatin|"Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.~Maintenance Therapy: Pemetrexed 500 mg/m^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met."
11036195|NCT01232452|EG000|Reported Event|Pemetrexed + Cisplatin + Cixutumumab|"Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 plus cixutumumab 20 mg/kg given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.~Maintenance Therapy: Pemetrexed 500 mg/m^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met."
11036196|NCT01232452|EG001|Reported Event|Pemetrexed + Cisplatin|"Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.~Maintenance Therapy: Pemetrexed 500 mg/m^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met."
11036197|NCT01232465|BG000|Baseline|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
11036198|NCT01232465|BG001|Baseline|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
11036199|NCT01232465|BG002|Baseline|Total|Total of all reporting groups
11036200|NCT01232465|FG000|Participant Flow|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
11036201|NCT01232465|FG001|Participant Flow|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
11036202|NCT01232465|OG000|Outcome|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
11036203|NCT01232465|OG001|Outcome|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
11036204|NCT01232465|EG000|Reported Event|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
11036205|NCT01232465|EG001|Reported Event|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
11036206|NCT01232491|BG000|Baseline|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
11036207|NCT01232491|BG001|Baseline|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
11036208|NCT01232491|BG002|Baseline|Total|Total of all reporting groups
11036209|NCT01232491|FG000|Participant Flow|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
11036210|NCT01232491|FG001|Participant Flow|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
11036211|NCT01232491|OG000|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
11036212|NCT01232491|OG001|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
11036213|NCT01232491|EG000|Reported Event|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
11036214|NCT01232491|EG001|Reported Event|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
11036215|NCT01232504|BG000|Baseline|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036216|NCT01232504|BG001|Baseline|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036217|NCT01232504|BG002|Baseline|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036218|NCT01232504|BG003|Baseline|Total|Total of all reporting groups
11036219|NCT01232504|FG000|Participant Flow|rhGM-CSF Group|subcutaneous recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036220|NCT01232504|FG001|Participant Flow|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) and 2-3μg/kg/d recombinant human granulocyte stimulating factor (rhG-CSF) each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036221|NCT01232504|FG002|Participant Flow|rhG-CSF Group|subcutaneous recombinant human granulocyte stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036222|NCT01232504|OG000|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036223|NCT01232504|OG001|Outcome|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036224|NCT01232504|OG002|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036225|NCT01232504|OG001|Outcome|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036226|NCT01232504|OG002|Outcome|rhG-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036227|NCT01232504|OG000|Outcome|rhGM-CSF|"5-7μg/kg per day~rhGM-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
11036228|NCT01232504|OG001|Outcome|rhGM-CSF Plus rhG-CSF|"rhGM-CSF and rhG-CSF both at 2-3μg/kg per day~rhGM-CSF plus rhG-CSF: rhGM-CSF and rhG-CSF (both at 2-3μg/kg/d) subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
11036229|NCT01232504|OG002|Outcome|rhG-CSF|"5-7μg/kg per day~rhG-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
11036230|NCT01232504|OG001|Outcome|rhG-CSF+ rhGM-CSF|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036231|NCT01232504|OG001|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036232|NCT01232504|OG002|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036233|NCT01232504|EG000|Reported Event|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036234|NCT01232504|EG001|Reported Event|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036235|NCT01232504|EG002|Reported Event|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
11036236|NCT01232556|BG000|Baseline|Inotuzumab Ozogamicin+Rituximab|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
11036237|NCT01232556|BG001|Baseline|Rituximab+Gemcitabine or Rituximab+Bendamustine|Participants received either R-bendamustine (rituximab 375 mg/m^2 via IV infusion on Day 1 and bendamustine 120 mg/m^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
11036238|NCT01232556|BG002|Baseline|Total|Total of all reporting groups
11036239|NCT01232556|FG000|Participant Flow|Inotuzumab Ozogamicin Plus (+) Rituximab|Participants received rituximab 375 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
11036240|NCT01232556|FG001|Participant Flow|Rituximab+Gemcitabine or Rituximab+Bendamustine|Participants received either R-bendamustine (rituximab 375 mg/m^2 via IV infusion on Day 1 and bendamustine 120 mg/m^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
11036241|NCT01232556|OG000|Outcome|Inotuzumab Ozogamicin+Rituximab|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
11036242|NCT01232556|OG001|Outcome|Rituximab+Gemcitabine or Rituximab+Bendamustine|Participants received either R-bendamustine (rituximab 375 mg/m^2 via IV infusion on Day 1 and bendamustine 120 mg/m^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
11036243|NCT01232556|EG000|Reported Event|Inotuzumab Ozogamicin+Rituximab|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
11036244|NCT01232556|EG001|Reported Event|Rituximab+Gemcitabine or Rituximab+Bendamustine|Participants received either R-bendamustine (rituximab 375 mg/m^2 via IV infusion on Day 1 and bendamustine 120 mg/m^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
11036245|NCT01232569|BG000|Baseline|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
11036246|NCT01232569|BG001|Baseline|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
11036247|NCT01232569|BG002|Baseline|Total|Total of all reporting groups
11036248|NCT01232569|FG000|Participant Flow|Tocilizumab 162 mg sc - Double-blind Treatment Period|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
11036249|NCT01232569|FG001|Participant Flow|Placebo sc - Double-blind Treatment Period|Patients received placebo sc every 2 weeks for 24 weeks.
11036250|NCT01232569|FG002|Participant Flow|Tocilizumab Pre-filled Syringe - Open-label Extension Period|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
11036251|NCT01232569|FG003|Participant Flow|Tocilizumab Auto-injector - Open-label Extension Period|Patients received tocilizumab 162 mg sc via auto-injector every 2 weeks for 72 weeks.
11036252|NCT01232569|OG000|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
11036253|NCT01232569|OG001|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
11036254|NCT01232569|EG000|Reported Event|Tocilizumab Pre-filled Syringe|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks. In addition, this reporting group includes participants re-randomized at Week 24 to tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks (Weeks 25-96).
11036255|NCT01232569|EG001|Reported Event|Placebo Pre-filled Syringe|Patients received placebo subcutaneously (sc) via a pre-filled syringe every 2 weeks for 24 weeks.
11036256|NCT01232569|EG002|Reported Event|Tocilizumab Pre-filled Syringe to Tocilizumab Auto-injector|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
11036257|NCT01232569|EG003|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Pre-filled Syringe|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
11036258|NCT01232569|EG004|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Autoinjector|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
11036259|NCT01232738|BG000|Baseline|Rasagiline|Open label study of 2 mg rasagiline daily
11036260|NCT01232738|FG000|Participant Flow|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
11036261|NCT01232738|OG000|Outcome|ALSRFS-R Slope - Rasagiline|Change in ALSRFS-R at 12 months
11036262|NCT01232738|OG001|Outcome|ALSFRS-R - Historical Placebo Control|Change in slope in the Historical Placebo Control group
11036263|NCT01232738|OG000|Outcome|Difference in Time to Treatment Failure - Rasagiline|This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or noninvasive ventilation >=23 hours/day for 14 days.
11036264|NCT01232738|OG001|Outcome|Difference in Time to Treatment Failure - Historical Control|Historical Controls were from the previous ALS trials.
11036265|NCT01232738|OG000|Outcome|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
11036266|NCT01232738|EG000|Reported Event|Rasagiline|"Treated for 12 months with rasagiline 2mg orally, once daily.~rasagiline: rasagiline 2 mg daily for 12 months"
11036267|NCT01232790|BG000|Baseline|Participants|This is the overall group of trial participants prior to randomization to either of the two crossover arms in the study.
11036268|NCT01232790|FG000|Participant Flow|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
11036269|NCT01232790|FG001|Participant Flow|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
11036270|NCT01232790|OG000|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
11036271|NCT01232790|OG001|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
11036272|NCT01232790|OG000|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
11036273|NCT01232790|OG001|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and the receives rge commercially available sustained release form of NAC, in each arm the capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
11036274|NCT01232790|OG001|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
11036275|NCT01232790|OG001|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
11036276|NCT01232790|OG000|Outcome|Intervention|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
11036277|NCT01232790|OG001|Outcome|Placebo|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
11036278|NCT01232790|OG000|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
10848895|NCT00292318|EG001|Reported Event|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
11036279|NCT01232790|OG001|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
11036280|NCT01232790|EG000|Reported Event|Placebo: First Crossover Follow Up|This group of participants received the placebo on the first day in the crossover design.
11036281|NCT01232790|EG001|Reported Event|NAC: First Crossover Follow Up|This group of participants received the active treatment (NAC) on the first day of the crossover study.
11036282|NCT01232790|EG002|Reported Event|Placebo: Second Crossover Follow Up|This group of participants received the placebo on the second day in the crossover design.
11036283|NCT01232790|EG003|Reported Event|NAC: Second Crossover Follow Up|This group of participants received the active treatment (NAC) on the second day of the crossover study.
11036284|NCT01232829|BG000|Baseline|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
11036285|NCT01232829|FG000|Participant Flow|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
11036286|NCT01232829|OG000|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
11036287|NCT01232829|EG000|Reported Event|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
11036288|NCT01232868|BG000|Baseline|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
11036289|NCT01232868|BG001|Baseline|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
11036290|NCT01232868|BG002|Baseline|Total|Total of all reporting groups
11036291|NCT01232868|FG000|Participant Flow|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
11036292|NCT01232868|FG001|Participant Flow|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
11036293|NCT01232868|OG000|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
11036294|NCT01232868|OG001|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
11036295|NCT01232868|EG000|Reported Event|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
11036296|NCT01232868|EG001|Reported Event|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
11036297|NCT01232894|BG000|Baseline|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
11036298|NCT01232894|BG001|Baseline|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
11036299|NCT01232894|BG002|Baseline|Total|Total of all reporting groups
11036300|NCT01232894|FG000|Participant Flow|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
11036301|NCT01232894|FG001|Participant Flow|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
11036302|NCT01232894|OG000|Outcome|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
11036303|NCT01232894|OG001|Outcome|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
11036304|NCT01232894|EG000|Reported Event|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
11036305|NCT01232894|EG001|Reported Event|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
11036306|NCT01232920|BG000|Baseline|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
11036307|NCT01232920|BG001|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
11036308|NCT01232920|BG002|Baseline|Total|Total of all reporting groups
11036309|NCT01232920|FG000|Participant Flow|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
11036310|NCT01232920|FG001|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
11036311|NCT01232920|OG000|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
11036312|NCT01232920|OG001|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
11036313|NCT01232920|EG000|Reported Event|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
11036314|NCT01232920|EG001|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
11036315|NCT01232946|BG000|Baseline|Iiraglutide|"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~liraglutide: 1.8mg subcutaneous qd for 3 months"
11036316|NCT01232946|BG001|Baseline|Insulin Detemir|"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~insulin detemir: 5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months"
11036317|NCT01232946|BG002|Baseline|Liraglutide Plus Insulin Detemir|"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months."
11036318|NCT01232946|BG003|Baseline|Total|Total of all reporting groups
11036319|NCT01232946|FG000|Participant Flow|Iiraglutide|"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~liraglutide: 1.8mg subcutaneous qd for 3 months"
11036320|NCT01232946|FG001|Participant Flow|Insulin Detemir|"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~insulin detemir: 5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months"
11036321|NCT01232946|FG002|Participant Flow|Liraglutide Plus Insulin Detemir|"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months."
11036322|NCT01232946|OG000|Outcome|Iiraglutide|"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~liraglutide: 1.8mg subcutaneous qd for 3 months"
11036323|NCT01232946|OG001|Outcome|Insulin Detemir|"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~insulin detemir: 5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months"
11036324|NCT01232946|OG002|Outcome|Liraglutide Plus Insulin Detemir|"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months."
11036325|NCT01232946|EG000|Reported Event|Iiraglutide|"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~liraglutide: 1.8mg subcutaneous qd for 3 months"
11036326|NCT01232946|EG001|Reported Event|Insulin Detemir|"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~insulin detemir: 5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months"
11036327|NCT01232946|EG002|Reported Event|Liraglutide Plus Insulin Detemir|"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.~liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months."
11036328|NCT01233050|BG000|Baseline|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
11036329|NCT01233050|BG001|Baseline|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
11036330|NCT01233050|BG002|Baseline|Total|Total of all reporting groups
11036331|NCT01233050|FG000|Participant Flow|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
11036332|NCT01233050|FG001|Participant Flow|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
11036333|NCT01233050|OG000|Outcome|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
11036334|NCT01233050|OG001|Outcome|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
11036335|NCT01233050|EG000|Reported Event|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
11036336|NCT01233050|EG001|Reported Event|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
11036337|NCT01233076|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
11036338|NCT01233076|FG000|Participant Flow|Nelfilcon A / Narafilcon B|Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
11036339|NCT01233076|FG001|Participant Flow|Narafilcon B / Nelfilcon A|Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
11036340|NCT01233076|OG000|Outcome|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
11036341|NCT01233076|OG001|Outcome|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
11036342|NCT01233076|EG000|Reported Event|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
11036343|NCT01233076|EG001|Reported Event|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
11036344|NCT01233232|BG000|Baseline|Placebo|4 x placebo capsules, twice daily (bid)
11036345|NCT01233232|BG001|Baseline|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
11036346|NCT01233232|BG002|Baseline|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
11036347|NCT01233232|BG003|Baseline|Total|Total of all reporting groups
11036348|NCT01233232|FG000|Participant Flow|Placebo|4 x placebo capsules, twice daily (bid)
11036349|NCT01233232|FG001|Participant Flow|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
11036350|NCT01233232|FG002|Participant Flow|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
11036351|NCT01233232|OG000|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
11036352|NCT01233232|OG001|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
11036353|NCT01233232|OG002|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
11036354|NCT01233232|OG000|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
11036355|NCT01233232|OG001|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
11036356|NCT01233232|EG000|Reported Event|Placebo|4 x placebo capsules, twice daily (bid)
11036357|NCT01233232|EG001|Reported Event|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
11036358|NCT01233232|EG002|Reported Event|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
11036359|NCT01233258|BG000|Baseline|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
11036360|NCT01233258|BG001|Baseline|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
11036361|NCT01233258|BG002|Baseline|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
11036362|NCT01233258|BG003|Baseline|Total|Total of all reporting groups
11036363|NCT01233258|FG000|Participant Flow|On Demand, BAY 81-8973 Potency First EP Then ADJ|Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months.
11036364|NCT01233258|FG001|Participant Flow|On Demand, BAY 81-8973 Potency First ADJ Then EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ for 6 months, followed by cross-over to study drug assayed by CS/EP for 6 months.
11036365|NCT01233258|FG002|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII(BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
11036366|NCT01233258|FG003|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
11036367|NCT01233258|FG004|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
11036368|NCT01233258|FG005|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII(BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
11036369|NCT01233258|OG000|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
11036370|NCT01233258|OG001|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
11036371|NCT01233258|OG000|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
11036372|NCT01233258|OG001|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/EP|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months.
11036373|NCT01233258|OG000|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
11036374|NCT01233258|OG001|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/ADJ|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
11036375|NCT01233258|OG001|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
11149074|NCT01868503|BG000|Baseline|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
11149075|NCT01868503|FG000|Participant Flow|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
11149076|NCT01868503|OG000|Outcome|Lapatinib Plus Radiation Therapy|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
11149077|NCT01868503|OG000|Outcome|All Participants|
11149078|NCT01868503|OG000|Outcome|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
11149079|NCT01868503|EG000|Reported Event|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
11149080|NCT01868542|BG000|Baseline|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
11149081|NCT01868542|BG001|Baseline|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
11149082|NCT01868542|BG002|Baseline|Total|Total of all reporting groups
11149083|NCT01868542|FG000|Participant Flow|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
11149084|NCT01868542|FG001|Participant Flow|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
11149085|NCT01868542|OG000|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
11149086|NCT01868542|OG001|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
11036376|NCT01233258|OG000|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
11036377|NCT01233258|OG001|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
11036378|NCT01233258|OG002|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
11036379|NCT01233258|OG001|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
11036380|NCT01233258|OG002|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
11036381|NCT01233258|EG000|Reported Event|rFVIII (BAY81-8973) Treatment|Participants received on-demand or prophylaxis treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization
11036382|NCT01233284|BG000|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
11036383|NCT01233284|FG000|Participant Flow|Tio R5 Once Daily(qd)/Tio R1.25 qd/Placebo/Tio R2.5 qd|Patients treated with Tiotropium 5 mcg in period 1 (evening), with Tiotropium 1.25 mcg in period 2 (evening), with a matching Placebo in period 3 (evening) and with Tiotropium 2.5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroids (ICS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11036384|NCT01233284|FG001|Participant Flow|Tio R2.5 qd/Placebo/Tio R1.25 qd/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (evening), with a matching Placebo in period 2 (evening), with Tiotropium 1.25 mcg in period 3 (evening) and with Tiotropium 5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11036385|NCT01233284|FG002|Participant Flow|Tio R1.25 qd/Tio R2.5 qd/Tio R5 qd/Placebo|Patients treated with Tiotropium 1.25 mcg in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with a matching placebo in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroid ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11036386|NCT01233284|FG003|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 qd/Tio R1.25 qd|Patients treated with a matching Placebo in period 1 (evening), with Tiotropium 5 mcg in period 2 (evening), with Tiotropium 2.5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11036387|NCT01233284|FG004|Participant Flow|Placebo/Tio R2.5 qd/Tio R5 qd/Tio R1.25 qd|Patient treated with a matching Placebo in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
11036388|NCT01233284|OG000|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
11036389|NCT01233284|OG001|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
11036390|NCT01233284|OG002|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
11036391|NCT01233284|OG003|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
11036392|NCT01233284|EG000|Reported Event|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
11036393|NCT01233284|EG001|Reported Event|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
11036394|NCT01233284|EG002|Reported Event|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
11036395|NCT01233284|EG003|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
11036396|NCT01233518|BG000|Baseline|Single Arm Study|"Patients will receive cCTA, ICA, FFR, and cFFR per protocol.~FFR: Fractional flow reserve measured during cardiac catheterization"
11036397|NCT01233518|FG000|Participant Flow|Single Arm Study|"Patients will receive cCTA, ICA, FFR, and cFFR per protocol.~FFR: Fractional flow reserve measured during cardiac catheterization"
11036398|NCT01233518|OG000|Outcome|Single Arm Study|Per-patient performance (diagnostic accuracy) CCTA plus FFRCT
11036399|NCT01233518|OG000|Outcome|Single Arm Study|"Patients will receive cCTA, ICA, FFR, and cFFR per protocol.~FFR: Fractional flow reserve measured during cardiac catheterization"
11036400|NCT01233518|EG000|Reported Event|Single Arm Study|"Patients will receive cCTA, ICA, FFR, and cFFR per protocol.~FFR: Fractional flow reserve measured during cardiac catheterization"
11036401|NCT01233609|BG000|Baseline|Placebo|"Subjects who receive placebo~Placebo: Dosage per subject weight- same schedule as the active comparator"
11036402|NCT01233609|BG001|Baseline|Valproic Acid|"Subjects who receive valproic acid~Valproic Acid: One to four 250mg softgels by mouth daily (dose determined by body weight)"
11036403|NCT01233609|BG002|Baseline|Total|Total of all reporting groups
11036404|NCT01233609|FG000|Participant Flow|Valproic Acid|"Subjects who receive valproic acid~Valproic Acid: One to four 250mg softgels by mouth daily (dose determined by body weight)"
11036405|NCT01233609|FG001|Participant Flow|Placebo|"Subjects who receive placebo~Placebo: Dosage per subject weight- same schedule as the active comparator"
11036406|NCT01233609|OG000|Outcome|Placebo--Right Eye|Right eye of Placebo-treated patients
11036407|NCT01233609|OG001|Outcome|Placebo--Left Eye|Left eye of Placebo-treated patients
11036408|NCT01233609|OG002|Outcome|Valproic Acid--Right Eye|Right eye of Valproic acid-treated patients
11036409|NCT01233609|OG003|Outcome|Valproic Acid--Left Eye|Left eye of Valproic acid-treated patients
11036410|NCT01233609|OG003|Outcome|Valproic Acid--Left Eye|Left eye of Valproic Acid-treated patients
11036411|NCT01233609|OG000|Outcome|Placebo--Right Eye|Right eye of placebo-treated patients
11036412|NCT01233609|OG000|Outcome|Valproic Acid -- Right Eye|Results from the Right Eye in Patients treated with Valproic Acid
11036413|NCT01233609|OG001|Outcome|Valproic Acid--Left Eye|Results from the Left Eye in Patients treated with Valproic Acid
11036414|NCT01233609|OG002|Outcome|Placebo --Right Eye|Results from the Right Eye in Patients treated with Placebo
11036415|NCT01233609|OG003|Outcome|Placebo --Left Eye|Results from the Left Eye in Patients treated with Placebo
11036416|NCT01233609|EG000|Reported Event|Placebo|"Subjects who receive placebo~Placebo: Dosage per subject weight- same schedule as the active comparator"
11036417|NCT01233609|EG001|Reported Event|Valproic Acid|"Subjects who receive valproic acid~Valproic Acid: One to four 250mg softgels by mouth daily (dose determined by body weight)"
11036418|NCT01233687|BG000|Baseline|AMG 102 + Erlotinib|
11036419|NCT01233687|FG000|Participant Flow|AMG 102 + Erlotinib|
11036420|NCT01233687|OG000|Outcome|AMG 102 + Erlotinib|
11036421|NCT01233687|EG000|Reported Event|AMG 102 + Erlotinib|"Serious and Non-Serious Adverse Events include the events considered at least possibly, probably or definitely related to study treatment.~Non-Serious (Other) Adverse Events include those that occurred with a frequency of more than or equal to 5%."
11036422|NCT01233726|BG000|Baseline|DIABA HP|"Patients of this group received new-generation diabetes-specific high-protein formula (Diaba HP®, Vegenat, Badajoz, Spain); as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg/ day for 28 days, via gastric or transpyloric."
11036423|NCT01233726|BG001|Baseline|ISOSOURCE PROTEIN FIBRE|"Patients of this group will received ISOSOURCE PROTEIN FIBRE (Nestlé Health Science, barcelona, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
11036424|NCT01233726|BG002|Baseline|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Nutrition, Madrid, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
11036425|NCT01233726|BG003|Baseline|Total|Total of all reporting groups
11036426|NCT01233726|FG000|Participant Flow|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
11036427|NCT01233726|FG001|Participant Flow|ISOSOURCE PROTEIN FIBRE|"Patients of this group received ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
11036428|NCT01233726|FG002|Participant Flow|GLUCERNA SELECT|"Patients of this group received GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
11036429|NCT01233726|OG000|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
11036430|NCT01233726|OG001|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
11036431|NCT01233726|OG002|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
11036432|NCT01233726|OG000|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
11036433|NCT01233726|OG001|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
11036434|NCT01233726|OG002|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
11036435|NCT01233726|EG000|Reported Event|DIABA HP|"Patients of this group received Diaba HP® as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
11036436|NCT01233726|EG001|Reported Event|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
11036437|NCT01233726|EG002|Reported Event|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg/ day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg / day for 28 days, via gastric or transpyloric."
11036438|NCT01233817|BG000|Baseline|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
11036439|NCT01233817|FG000|Participant Flow|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
11036440|NCT01233817|OG000|Outcome|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
11036441|NCT01233817|EG000|Reported Event|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
11036442|NCT01233869|BG000|Baseline|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
11036443|NCT01233869|BG001|Baseline|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
11036444|NCT01233869|BG002|Baseline|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
11036445|NCT01233869|BG003|Baseline|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
11036446|NCT01233869|BG004|Baseline|Total|Total of all reporting groups
11036447|NCT01233869|FG000|Participant Flow|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
11036448|NCT01233869|FG001|Participant Flow|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
11036449|NCT01233869|FG002|Participant Flow|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
11036450|NCT01233869|FG003|Participant Flow|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
11036451|NCT01233869|OG000|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
11036452|NCT01233869|OG001|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
11036453|NCT01233869|OG002|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
11036454|NCT01233869|OG003|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
11036455|NCT01233869|EG000|Reported Event|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
11036456|NCT01233869|EG001|Reported Event|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
11036457|NCT01233869|EG002|Reported Event|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
11036458|NCT01233869|EG003|Reported Event|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
11036459|NCT01233921|BG000|Baseline|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
11036460|NCT01233921|BG001|Baseline|Arm II (no Palifermin)|Patients do not receive palifermin.
11036461|NCT01233921|BG002|Baseline|Total|Total of all reporting groups
11036462|NCT01233921|FG000|Participant Flow|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
11036463|NCT01233921|FG001|Participant Flow|Arm II (no Palifermin)|Patients do not receive palifermin.
11036464|NCT01233921|OG000|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
11036465|NCT01233921|OG001|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
11036466|NCT01233921|EG000|Reported Event|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
11036467|NCT01233921|EG001|Reported Event|Arm II (no Palifermin)|Patients do not receive palifermin.
11036468|NCT01233999|BG000|Baseline|Botox|single-drug dosage comparison cross-over study
11036469|NCT01233999|FG000|Participant Flow|Botox|Participants will be randomly assigned to receive 1 injection with Botulinum toxin A, 40 units in either the left or right hand.
11036470|NCT01233999|OG000|Outcome|Botox|single-drug dosage comparison cross-over study
11036471|NCT01233999|EG000|Reported Event|Botox|single-drug dosage comparison cross-over study
11036472|NCT01234207|BG000|Baseline|All Study Participants|Crossover trial: all study participants received both Test and Control spectacles, in randomized order.
11036473|NCT01234207|FG000|Participant Flow|Group 1 - Control Spectacles Worn First, Then Test Spectacles|Crossover trial; 2 arms: subjects randomized to wear Control spectacles 1st, then Test spectacles 2nd
11036474|NCT01234207|FG001|Participant Flow|Group 2 - Test Spectacles Worn First, Then Control Spectacles|Crossover trial; 2 arms: subjects randomized to wear Test spectacles 1st, then Control spectacles 2nd
11036475|NCT01234207|OG000|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
11036476|NCT01234207|OG001|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
11036477|NCT01234207|OG000|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
11036478|NCT01234207|OG001|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
11036479|NCT01234207|EG000|Reported Event|Control Spectacles|"Arm/Groups Adverse Events are reported per intervention"
11036480|NCT01234207|EG001|Reported Event|Test Spectacles|"Arm/Groups Adverse Events are reported per intervention"
11036481|NCT01234337|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Sorafenib tablets were administered orally continuously at a total daily dose of 600 mg (200 mg in the morning, 400 mg in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and sorafenib dose to a total daily dose of 800 mg for that participant.
11036482|NCT01234337|BG001|Baseline|Placebo + Capecitabine|Placebo tablets matching with sorafenib were administered orally continuously (1 tablet in the morning, 2 tablets in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that participant.
11036483|NCT01234337|BG002|Baseline|Total|Total of all reporting groups
11036484|NCT01234337|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Sorafenib tablets were administered orally continuously at a total daily dose of 600 mg (200 mg in the morning, 400 mg in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and sorafenib dose to a total daily dose of 800 mg for that participant.
11226119|NCT02371876|OG000|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
11036485|NCT01234337|FG001|Participant Flow|Placebo + Capecitabine|Placebo tablets matching with sorafenib were administered orally continuously (1 tablet in the morning, 2 tablets in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that participant.
11036486|NCT01234337|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Sorafenib tablets were administered orally continuously at a total daily dose of 600 mg (200 mg in the morning, 400 mg in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and sorafenib dose to a total daily dose of 800 mg for that participant.
11036487|NCT01234337|OG001|Outcome|Placebo + Capecitabine|Placebo tablets matching with sorafenib were administered orally continuously (1 tablet in the morning, 2 tablets in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a participant, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that participant.
11036488|NCT01234337|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Sorafenib tablets were administered orally continuously at a total daily dose of 600 mg (200 mg in the morning, 400 mg in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a subject, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and sorafenib dose to a total daily dose of 800 mg for that subject.
11036489|NCT01234337|EG001|Reported Event|Placebo + Capecitabine|Placebo tablets matching with sorafenib were administered orally continuously (1 tablet in the morning, 2 tablets in the evening) in a 3-week cycle. Capecitabine was administered orally at a total daily dose of 2,000 mg/m^2 (1,000 mg/m^2 twice daily, 12 hours apart). If tolerability criteria were met for a subject, capecitabine dose was escalated to 2,500 mg/m^2 total daily dose (1,250 mg/m^2 twice daily) and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
11036490|NCT01234350|BG000|Baseline|FIRMAGON|FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label
11036491|NCT01234350|BG001|Baseline|GnRH Agonist|Any GnRH agonist prescribed in accordance with the approved labels
11036492|NCT01234350|BG002|Baseline|Total|Total of all reporting groups
11036493|NCT01234350|FG000|Participant Flow|FIRMAGON|FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label
11036494|NCT01234350|FG001|Participant Flow|GnRH Agonist|Any GnRH agonist prescribed in accordance with the approved labels
11036495|NCT01234350|OG000|Outcome|FIRMAGON|FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label
11036496|NCT01234350|OG001|Outcome|GnRH Agonist|Any GnRH agonist prescribed in accordance with the approved labels
11036497|NCT01234350|OG001|Outcome|GnRH Agonist|Any GnRH prescribed in accordance with the approved labels
11036498|NCT01234350|OG001|Outcome|GnRH Agonist|Any GnRH Agonist prescribed in accordance with the approved labels
11036499|NCT01234350|EG000|Reported Event|FIRMAGON|FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label
11036500|NCT01234350|EG001|Reported Event|GnRH Agonist|Any GnRH agonist prescribed in accordance with the approved labels
11036501|NCT01234402|BG000|Baseline|Ramucirumab + Capecitabine|Participants received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036502|NCT01234402|BG001|Baseline|Icrucumab + Capecitabine|Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036503|NCT01234402|BG002|Baseline|Capecitabine|"Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.~After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;~Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.~Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle."
11036504|NCT01234402|BG003|Baseline|Total|Total of all reporting groups
11036505|NCT01234402|FG000|Participant Flow|Ramucirumab + Capecitabine|Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036506|NCT01234402|FG001|Participant Flow|Icrucumab + Capecitabine|Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036507|NCT01234402|FG002|Participant Flow|Capecitabine|"Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.~After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;~Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.~Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle."
11036508|NCT01234402|OG000|Outcome|Ramucirumab + Capecitabine|Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036509|NCT01234402|OG001|Outcome|Icrucumab + Capecitabine|Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036510|NCT01234402|OG002|Outcome|Capecitabine|"Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.~After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;~Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.~Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle."
11036511|NCT01234402|EG000|Reported Event|Ramucirumab + Capecitabine|Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per meter square (mg/m*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036512|NCT01234402|EG001|Reported Event|Icrucumab + Capecitabine|Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 milligram per meter square (mg/m*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036513|NCT01234402|EG002|Reported Event|Capecitabine|Participants received 1000 mg/m*2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036514|NCT01234402|EG003|Reported Event|Crossover to Ramucirumab DP + Capecitabine|Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per meter square (mg/m*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036515|NCT01234402|EG004|Reported Event|Crossover to Icrucumab + Capecitabine|Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 milligram per meter square (mg/m*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
11036516|NCT01234467|BG000|Baseline|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
11036517|NCT01234467|FG000|Participant Flow|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
11036518|NCT01234467|OG000|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
11036519|NCT01234467|EG000|Reported Event|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
11036520|NCT01234480|BG000|Baseline|All Evaluable Participants|All participants with satisfactory samples at completion of the study.
11036521|NCT01234480|FG000|Participant Flow|All Study Participants|All Enrolled Participants - Cervical cancer status was not known upon enrollment
11036522|NCT01234480|OG000|Outcome|SurePath Plus|Samples tested on the SurePath Plus
11036523|NCT01234480|OG001|Outcome|SurePath Pap|Samples tested on the SurePath Pap
11036524|NCT01234480|OG000|Outcome|SurePath Plus With Immunostain|Samples tested on the SurePath Plus
11036525|NCT01234480|OG001|Outcome|SurePath Pap With HPV|Samples tested on the SurePath Pap
11036526|NCT01234480|EG000|Reported Event|All Evaluable Participants|All participants with satisfactory samples at completion of the study.
11036527|NCT01234649|BG000|Baseline|Metformin XR Plus Liraglutide|"Metformin XR plus Liraglutide Metformin extended release (XR) 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid- 84 weeks (end study) Liraglutide - start .6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated~Metformin XR plus liraglutide: Metformin XR-500 qd for 2 weeks, 500 mg bid 2 weeks; 500 mg am, 1000 mg pm- 2 weeks - 1000 bid final dose Liraglutide- start 0.6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated during the 4-wk non-forced dose-escalation period ( maximum allowed dose of 1.8 mg SC QD)"
11036528|NCT01234649|BG001|Baseline|Metformin XR Plus Placebo|"Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -84 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated~Metformin XR plus placebo: Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -98 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated"
11036529|NCT01234649|BG002|Baseline|Total|Total of all reporting groups
11036530|NCT01234649|FG000|Participant Flow|Metformin XR Plus Liraglutide|"Metformin XR plus Liraglutide Metformin extended release (XR) 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid- 84 weeks (end study) Liraglutide - start .6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated~Metformin XR plus liraglutide: Metformin XR-500 qd for 2 weeks, 500 mg bid 2 weeks; 500 mg am, 1000 mg pm- 2 weeks - 1000 bid final dose Liraglutide- start 0.6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated during the 4-wk non-forced dose-escalation period ( maximum allowed dose of 1.8 mg SC QD)"
11036531|NCT01234649|FG001|Participant Flow|Metformin XR Plus Placebo|"Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -84 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated~Metformin XR plus placebo: Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -98 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated"
11036532|NCT01234649|OG000|Outcome|Metformin XR Plus Liraglutide|"Metformin XR plus Liraglutide Metformin extended release (XR) 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid- 84 weeks (end study) Liraglutide - start .6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated~Metformin XR plus liraglutide: Metformin XR-500 qd for 2 weeks, 500 mg bid 2 weeks; 500 mg am, 1000 mg pm- 2 weeks - 1000 bid final dose Liraglutide- start 0.6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated during the 4-wk non-forced dose-escalation period ( maximum allowed dose of 1.8 mg SC QD)"
11036533|NCT01234649|OG001|Outcome|Metformin XR Plus Placebo|"Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -84 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated~Metformin XR plus placebo: Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -98 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated"
11036534|NCT01234649|EG000|Reported Event|Metformin XR Plus Liraglutide|"Metformin XR plus Liraglutide Metformin extended release (XR) 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid- 84 weeks (end study) Liraglutide - start .6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated~Metformin XR plus liraglutide: Metformin XR-500 qd for 2 weeks, 500 mg bid 2 weeks; 500 mg am, 1000 mg pm- 2 weeks - 1000 bid final dose Liraglutide- start 0.6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated during the 4-wk non-forced dose-escalation period ( maximum allowed dose of 1.8 mg SC QD)"
11036535|NCT01234649|EG001|Reported Event|Metformin XR Plus Placebo|"Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -84 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated~Metformin XR plus placebo: Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -98 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated"
11036536|NCT01234675|BG000|Baseline|All Study Participants|2 treatment period, with each period 6 weeks and 7 day washout period Milnacipran in treatment period 1, Placebo in treatment period 2 Placebo treatment in Period 1, and Milnacipran in Period 2
11036537|NCT01234675|FG000|Participant Flow|Placebo Then Milnacipran|50 mg twice daily (BID) maintenance dose
11036538|NCT01234675|FG001|Participant Flow|Milnacipran Then Placebo|50 mg twice daily (BID) maintenance dose
11036539|NCT01234675|OG000|Outcome|Milnacipran|Treatment with 50 mg BiD
11036540|NCT01234675|OG001|Outcome|Placebo|50 mg placebo BiD
11036541|NCT01234675|EG000|Reported Event|Milnacipran|Drug: milnacipran, 50 mg twice daily for 4 weeks.
11036542|NCT01234675|EG001|Reported Event|Placebo|Drug: Placebo 50 mg, twice daily for 4 weeks.
11036543|NCT01234714|BG000|Baseline|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
11036544|NCT01234714|FG000|Participant Flow|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
11036545|NCT01234714|OG000|Outcome|Clavien-Dindo Grade <IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.~No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification.~Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.~Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.~Blood transfusions and total parenteral nutrition are also included.~Grade III:Requiring surgical, endoscopic or radiological intervention"
11036546|NCT01234714|OG001|Outcome|Clavien-Dindo Grade ≥IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.~These are typically life-threatening complication (including CNS complications) requiring ICU management.~Grade IVa: single organ dysfunction (including dialysis)~Grade IVb: multi-organ dysfunction"
11036547|NCT01234714|OG000|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
11036548|NCT01234714|OG001|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
11036549|NCT01234714|EG000|Reported Event|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
11036550|NCT01234766|BG000|Baseline|Single Arm|"Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan~Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle~Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle~Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes"
11036551|NCT01234766|FG000|Participant Flow|Single Arm|"Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan~Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle~Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle~Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes"
11036552|NCT01234766|OG000|Outcome|Single Arm|"Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan~Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle~Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle~Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes"
11036553|NCT01234766|EG000|Reported Event|Single Arm|"Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan~Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle~Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle~Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes"
11036554|NCT01234831|BG000|Baseline|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
11036555|NCT01234831|BG001|Baseline|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
11036556|NCT01234831|BG002|Baseline|Total|Total of all reporting groups
11036557|NCT01234831|FG000|Participant Flow|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
11036558|NCT01234831|FG001|Participant Flow|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
11036559|NCT01234831|OG000|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
11036560|NCT01234831|OG001|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
11036561|NCT01234831|OG000|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
11036562|NCT01234831|OG000|Outcome|Active Screening With Contact Precautions Removed|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays. Contact Precautions will be removed for subjects who are cleared of colonization based on the study intervention.
11036563|NCT01234831|EG000|Reported Event|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
11036564|NCT01234870|BG000|Baseline|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
11036565|NCT01234870|FG000|Participant Flow|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
11036566|NCT01234870|OG000|Outcome|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
11036567|NCT01234870|OG000|Outcome|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
11036568|NCT01234870|EG000|Reported Event|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
11036569|NCT01234883|BG000|Baseline|Plasma-Lyte A|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
11036570|NCT01234883|BG001|Baseline|0.9% Saline|saline: IV saline solution dosed as clinically indicated for rehydration
11036571|NCT01234883|BG002|Baseline|Total|Total of all reporting groups
11036572|NCT01234883|FG000|Participant Flow|Multiple Electrolyte Solution|Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP): IV multiple electrolyte solution dosed as clinically indicated for rehydration.
11036573|NCT01234883|FG001|Participant Flow|Saline|0.9% Normal Saline: IV saline solution dosed as clinically indicated for rehydration
11036574|NCT01234883|OG000|Outcome|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
11036575|NCT01234883|OG001|Outcome|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
11036576|NCT01234883|EG000|Reported Event|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
11036577|NCT01234883|EG001|Reported Event|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
11036578|NCT01234922|BG000|Baseline|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
11036579|NCT01234922|BG001|Baseline|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
11036580|NCT01234922|BG002|Baseline|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
11036581|NCT01234922|BG003|Baseline|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
11036582|NCT01234922|BG004|Baseline|Total|Total of all reporting groups
11036583|NCT01234922|FG000|Participant Flow|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
11036584|NCT01234922|FG001|Participant Flow|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
11036585|NCT01234922|FG002|Participant Flow|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
11036586|NCT01234922|FG003|Participant Flow|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
11036587|NCT01234922|OG000|Outcome|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
11036588|NCT01234922|OG001|Outcome|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
11036589|NCT01234922|OG002|Outcome|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
11036590|NCT01234922|OG003|Outcome|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
11036591|NCT01234922|EG000|Reported Event|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
11036592|NCT01234922|EG001|Reported Event|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
11036593|NCT01234922|EG002|Reported Event|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
11036594|NCT01234922|EG003|Reported Event|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
11036595|NCT01235195|BG000|Baseline|Entire Study Population|Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet
11036596|NCT01235195|FG000|Participant Flow|Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet|Sertraline Hydrochloride 50 milligram (mg) hard gelatin capsule in the first intervention period, Sertraline Hydrochloride 50 mg Film-Coated Tablet in the second intervention period
11036597|NCT01235195|FG001|Participant Flow|Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule|Sertraline Hydrochloride 50 mg film-coated tablet in the first intervention period, Sertraline Hydrochloride 50 mg hard gelatin capsule in the second intervention period
11036598|NCT01235195|OG000|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
11036599|NCT01235195|OG001|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
11036600|NCT01235195|EG000|Reported Event|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
11036601|NCT01235195|EG001|Reported Event|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
11036615|NCT01235338|BG000|Baseline|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
11036616|NCT01235338|BG001|Baseline|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
11036617|NCT01235338|BG002|Baseline|Total|Total of all reporting groups
11036618|NCT01235338|FG000|Participant Flow|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
11036619|NCT01235338|FG001|Participant Flow|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
11036620|NCT01235338|OG000|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
11036621|NCT01235338|OG001|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
11036622|NCT01235338|EG000|Reported Event|LDX (SPD489)|Titration dosing period
11036623|NCT01235338|EG001|Reported Event|LDX + Venlafaxine XR/Venlafaxine XR + LDX|Combination dosing periods
11036624|NCT01235338|EG002|Reported Event|Venlafaxine XR Titration|Titration dosing period (Effexor XR 75, 150, and 225 mg)
11036625|NCT01235338|EG003|Reported Event|Venlafaxine XR Tapering|Tapering dosing period (Effexor XR 150 and 75 mg)
11036626|NCT01235351|BG000|Baseline|CYP2C19*2 Non-Carriers|
11036627|NCT01235351|BG001|Baseline|CYP2C19*2 Carriers|
11036628|NCT01235351|BG002|Baseline|Total|Total of all reporting groups
11036629|NCT01235351|FG000|Participant Flow|CYP2C19*2 Non-Carrier|Period 1: clopidogrel 75 mg and 150 mg for 14 days each Period 2: crossover to sequences of clopidogrel (75 mg first, then 150 mg, and 150 mg first, then 75 mg) for 14 days each.
11036630|NCT01235351|FG001|Participant Flow|CYP2C19*2 Carrier|Period 1: clopidogrel 75 mg and 150 mg for 14 days each Period 2: crossover to sequences of clopidogrel (225 mg first, then 300 mg, and 300 mg first, then 225 mg) for 14 days each.
11036631|NCT01235351|OG000|Outcome|CYP2C19*2 Carriers|Carrier of reduced function allele
11036632|NCT01235351|OG001|Outcome|CYP2C19*2 Non-Carriers|Not a carrier of reduced function allele
11036633|NCT01235351|EG000|Reported Event|CYP2C19*2 Carriers 75 mg|Patient with a carrier of genotype given 75 mg of the drug
11036634|NCT01235351|EG001|Reported Event|CYP2C19*2 Carriers 150 mg|Patient with a carrier of genotype given 150 mg of the drug
11036635|NCT01235351|EG002|Reported Event|CYP2C19*2 Carriers 225 mg|Patient with a carrier of genotype given 225 mg of the drug
11036636|NCT01235351|EG003|Reported Event|CYP2C19*2 Carriers 300mg|Patient with a carrier of genotype given 300 mg of the drug
11036637|NCT01235351|EG004|Reported Event|CYP2C19*2 Noncarriers 75 mg|Patients who are non-carriers of the genotype given 75 mg of the drug
11036638|NCT01235351|EG005|Reported Event|CYP2C19*2 Noncarriers 150 mg|Patients who are non-carriers of the genotype given 150 mg of the drug
11036639|NCT01235377|BG000|Baseline|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
11036640|NCT01235377|BG001|Baseline|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
11036641|NCT01235377|BG002|Baseline|Total|Total of all reporting groups
11036642|NCT01235377|FG000|Participant Flow|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
11036643|NCT01235377|FG001|Participant Flow|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
11036644|NCT01235377|OG000|Outcome|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
11036645|NCT01235377|OG001|Outcome|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
11036646|NCT01235377|EG000|Reported Event|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
11036647|NCT01235377|EG001|Reported Event|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
11036648|NCT01235403|BG000|Baseline|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day~Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
11036649|NCT01235403|FG000|Participant Flow|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
11036650|NCT01235403|OG000|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
11036651|NCT01235403|EG000|Reported Event|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day~Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
11036652|NCT01235442|BG000|Baseline|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
11036653|NCT01235442|BG001|Baseline|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
11036654|NCT01235442|BG002|Baseline|Total|Total of all reporting groups
11036655|NCT01235442|FG000|Participant Flow|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
11036656|NCT01235442|FG001|Participant Flow|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
11036657|NCT01235442|OG000|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
11036658|NCT01235442|OG001|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
11036659|NCT01235442|EG000|Reported Event|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
11036660|NCT01235442|EG001|Reported Event|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
11036661|NCT01235507|BG000|Baseline|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
11036662|NCT01235507|FG000|Participant Flow|Tocilizumab Plus Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum 800 mg) intravenously (IV) every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg per week (mg/week) of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
11036663|NCT01235507|OG000|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
11036664|NCT01235507|EG000|Reported Event|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
11036665|NCT01235546|BG000|Baseline|Placebo With Standard Prophylaxis|Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
11036666|NCT01235546|BG001|Baseline|Azithromycin (Zithromax) With Standard Prophylaxis|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
11036667|NCT01235546|BG002|Baseline|Total|Total of all reporting groups
11036668|NCT01235546|FG000|Participant Flow|Placebo and Standard of Care|Placebo: 250 cc normal saline Standard of care (cephazolin or clindamycin)
11036669|NCT01235546|FG001|Participant Flow|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and standard of care (cephazolin or clindamycin)
11036670|NCT01235546|OG000|Outcome|Placebo|"250 cc normal saline~Placebo: 250 cc normal saline"
11036671|NCT01235546|OG001|Outcome|Azithromycin|Azithromycin: 500 mg in 250 cc normal saline 1 time dose
11036672|NCT01235546|OG000|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and standard of care (cefazolin or clindamycin)
11036673|NCT01235546|OG001|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of Care (cefazolin or clindamycin
11036674|NCT01235546|OG000|Outcome|Placebo and Standard of Care|"250 cc normal saline~Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)"
11036675|NCT01235546|OG001|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
11036676|NCT01235546|OG000|Outcome|Placebo With Standard Prophylaxis|Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
11036677|NCT01235546|OG001|Outcome|Azithromycin (Zithromax) With Standard Prophylaxis|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
11036678|NCT01235546|OG000|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline Standard of care (cefazolin or clindamycin)
11036679|NCT01235546|OG001|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard of care (cefazolin or clindamycin)
11036680|NCT01235546|OG000|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
11036681|NCT01235546|EG000|Reported Event|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
11036682|NCT01235546|EG001|Reported Event|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline and Standard of care (cefazolin or clindamycin)
11036683|NCT01235598|BG000|Baseline|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
11036684|NCT01235598|BG001|Baseline|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
11036685|NCT01235598|BG002|Baseline|Total|Total of all reporting groups
11036686|NCT01235598|FG000|Participant Flow|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
11036687|NCT01235598|FG001|Participant Flow|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
11036688|NCT01235598|OG000|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
11036689|NCT01235598|OG001|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
11036690|NCT01235598|OG000|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
11036691|NCT01235598|OG001|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
11036692|NCT01235598|EG000|Reported Event|Certolizumab Pegol (CZP) at Any Time|"Eligible subjects were allocated to the following study treatments in a 2:1 ratio:~Certolizumab Pegol (CZP) 400mg for subcutaneous injection (sc) at Weeks 0, 2, and 4, followed by CZP 200mg sc and placebo (saline solution) at Week 6 and CZP 200mg at Weeks 8, 10, 12, 14, and 16 or~Placebo (saline solution) at Day 0 and then CZP 400mg sc at Weeks 2, 4, and 6 followed by CZP 200mg sc at Weeks 8, 10, 12, 14, and 16"
11036693|NCT01235689|BG000|Baseline|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
11036694|NCT01235689|BG001|Baseline|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
11036695|NCT01235689|BG002|Baseline|Total|Total of all reporting groups
11036696|NCT01235689|FG000|Participant Flow|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine.~Participants who randomized at Week 9 meeting success criteria started with no therapy; participants who randomized prior to Week 9 or who randomized at Week 9 but did not meet the success criteria began treatment with adalimumab.~Therapy was escalated according to pre-specified failure criteria using less stringent criteria:~At Key Visit 1 the criteria for management of disease activity were a CDAI decrease ≥ 70 (CR-70) compared to Baseline or CDAI < 200 at 1 week prior to the visit. At Key Visits 3, 4, and 5 (every 12 weeks after Key visit 1), the criteria for a change in treatment were a CDAI decrease of ≥ 100 (CR-100) compared to Baseline or CDAI < 200, and absence of prednisone during the preceding week."
11036697|NCT01235689|FG001|Participant Flow|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. Participants who randomized at Week 9 meeting success criteria started with no therapy; participants who randomized prior to Week 9 or who randomized at Week 9 but did not meet the success criteria began treatment with adalimumab.~Therapy was escalated according to pre-specified tight control criteria: At Key Visit 1 the success criteria were CDAI < 150, hs-CRP, < 5 mg/L, fecal calprotectin < 250 μg/g, and absence of prednisone use. At Key Visits 3, 4, and 5 (every 12 weeks after Key visit 1), the criteria were CDAI < 150, hs-CRP < 5 mg/L, fecal calprotectin < 250 μg/g, and absence of prednisone during the preceding week."
11036698|NCT01235689|OG000|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
10887303|NCT00499655|EG001|Reported Event|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
11036699|NCT01235689|OG001|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
11036700|NCT01235689|EG000|Reported Event|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
11036701|NCT01235689|EG001|Reported Event|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
11036702|NCT01235715|BG000|Baseline|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
11036703|NCT01235715|BG001|Baseline|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
11036704|NCT01235715|BG002|Baseline|Total|Total of all reporting groups
11036705|NCT01235715|FG000|Participant Flow|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
11036706|NCT01235715|FG001|Participant Flow|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
11036707|NCT01235715|OG000|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
11036708|NCT01235715|OG001|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
11036709|NCT01235715|OG001|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
11036710|NCT01235715|EG000|Reported Event|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
11036711|NCT01235715|EG001|Reported Event|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
11036712|NCT01235728|BG000|Baseline|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
11036713|NCT01235728|FG000|Participant Flow|Treatment Sequence 1|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
11036714|NCT01235728|FG001|Participant Flow|Treatment Sequence 2|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
11036715|NCT01235728|FG002|Participant Flow|Treatment Sequence 3|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
11036716|NCT01235728|FG003|Participant Flow|Treatment Sequence 4|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-873 on upper lesion D.
11036717|NCT01235728|FG004|Participant Flow|Treatment Sequence 5|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
11036718|NCT01235728|FG005|Participant Flow|Treatment Sequence 6|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
11036719|NCT01235728|FG006|Participant Flow|Treatment Sequence 7|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
11036720|NCT01235728|FG007|Participant Flow|Treatment Sequence 8|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.
11036721|NCT01235728|OG000|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
11036722|NCT01235728|OG001|Outcome|MK-0873 Vehicle|Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
11036723|NCT01235728|OG000|Outcome|Calcitriol 0.0003%|Participants were randomly assigned to receive calcitriol 0.0003% (3mg/g) BID for 28 days on upper or lower lesion C or D and MK-0873 on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
11036724|NCT01235728|OG001|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
11036725|NCT01235728|OG000|Outcome|MK-0873|Participants were randomized to receive MK- 0873 on upper or lower lesion A or B and MK-0873 Vehicle on the opposing lesion B or A, and MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C.
11036726|NCT01235728|EG000|Reported Event|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
11036727|NCT01235741|BG000|Baseline|Non-Randomized Lead-in LCD|6 Week Lead-in with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to study drug in the Randomization period.
11036728|NCT01235741|BG001|Baseline|Placebo|Self administered subcutaneous (SC ) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
11036729|NCT01235741|BG002|Baseline|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
11036730|NCT01235741|BG003|Baseline|Total|Total of all reporting groups
11036731|NCT01235741|FG000|Participant Flow|Low Calorie Diet Only|6 Week Lead-in Period with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to either study drug or placebo in the Randomization period.
11036732|NCT01235741|FG001|Participant Flow|Placebo|Self administered subcutaneous (SC) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
11036733|NCT01235741|FG002|Participant Flow|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 micrograms (µg) + metreleptin 5.0 milligrams (mg) BID for 16 weeks
11036734|NCT01235741|OG000|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
11036735|NCT01235741|OG001|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
11036736|NCT01235741|OG000|Outcome|On Treatment Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
11036737|NCT01235741|OG001|Outcome|On Treatment Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
11036738|NCT01235741|OG002|Outcome|Post Treatment Placebo Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
11036739|NCT01235741|OG003|Outcome|Post Treatment Pramlintide + Metreleptin Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
11036740|NCT01235741|OG000|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
10887304|NCT00499681|BG000|Baseline|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
11036741|NCT01235741|OG000|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
11036742|NCT01235741|EG000|Reported Event|Placebo-P + Placebo-M|Self administered subcutaneous injection once a day (QD) of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) for 1 week followed by BID dosing for 15 weeks (16 weeks total).
11036743|NCT01235741|EG001|Reported Event|Pramlintide + Metreleptin|Self administered subcutaneous injection once a day (QD) of pramlintide 360 micrograms (µg) plus metreleptin 5.0 milligrams (mg ) for 1 week followed by twice a week (BID) dosing for 15 weeks (Total of 16 Weeks treatment).
11036744|NCT01235793|BG000|Baseline|DRBEAT Regimen|Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m^2 (cumulative total dose of 1250 mg/m^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
11036745|NCT01235793|FG000|Participant Flow|DRBEAT Regimen|Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m^2 (cumulative total dose of 1250 mg/m^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
11036746|NCT01235793|OG000|Outcome|DRBEAT Regimen|Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m2 (cumulative total dose of 1250 mg/m2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
11036747|NCT01235793|OG000|Outcome|DRBEAT Regimen|Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m^2 (cumulative total dose of 1250 mg/m^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
11036748|NCT01235793|EG000|Reported Event|DRBEAT Regimen|Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m^2 (cumulative total dose of 1250 mg/m^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
11036749|NCT01235897|BG000|Baseline|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
11036750|NCT01235897|FG000|Participant Flow|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
11036751|NCT01235897|OG000|Outcome|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
11036752|NCT01235897|OG000|Outcome|MK-2206|MK-2206 given orally at a dose of 135 mg weekly + Trastuzumab 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg + Paclitaxel 80 mg/m2 weekly
11036753|NCT01235897|EG000|Reported Event|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
11036754|NCT01235910|BG000|Baseline|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
11036755|NCT01235910|FG000|Participant Flow|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
11036756|NCT01235910|OG000|Outcome|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
11036757|NCT01235910|EG000|Reported Event|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
11036758|NCT01235949|BG000|Baseline|IIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
11036759|NCT01235949|BG001|Baseline|DIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036760|NCT01235949|BG002|Baseline|NIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036761|NCT01235949|BG003|Baseline|IPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036762|NCT01235949|BG004|Baseline|DPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036763|NCT01235949|BG005|Baseline|NPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036764|NCT01235949|BG006|Baseline|IIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036765|NCT01235949|BG007|Baseline|IIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036766|NCT01235949|BG008|Baseline|IIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036767|NCT01235949|BG009|Baseline|DIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036768|NCT01235949|BG010|Baseline|DIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036769|NCT01235949|BG011|Baseline|DIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036770|NCT01235949|BG012|Baseline|NIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036771|NCT01235949|BG013|Baseline|NIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036772|NCT01235949|BG014|Baseline|NIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036773|NCT01235949|BG015|Baseline|IPARA-NPARA Group|Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036774|NCT01235949|BG016|Baseline|DPARA-IPARA Group|Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036775|NCT01235949|BG017|Baseline|NPARA-IPARA Group|Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036776|NCT01235949|BG018|Baseline|Total|Total of all reporting groups
11036777|NCT01235949|FG000|Participant Flow|IIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
11036778|NCT01235949|FG001|Participant Flow|DIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036779|NCT01235949|FG002|Participant Flow|NIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036780|NCT01235949|FG003|Participant Flow|IPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036781|NCT01235949|FG004|Participant Flow|DPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036782|NCT01235949|FG005|Participant Flow|NPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036783|NCT01235949|FG006|Participant Flow|IIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036784|NCT01235949|FG007|Participant Flow|IIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036785|NCT01235949|FG008|Participant Flow|IIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036786|NCT01235949|FG009|Participant Flow|DIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036787|NCT01235949|FG010|Participant Flow|DIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036788|NCT01235949|FG011|Participant Flow|DIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036789|NCT01235949|FG012|Participant Flow|NIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11226120|NCT02371876|OG000|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject venous blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. BG results were compared to reference method results obtained from subject venous plasma."
11036790|NCT01235949|FG013|Participant Flow|NIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036791|NCT01235949|FG014|Participant Flow|NIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036792|NCT01235949|FG015|Participant Flow|IPARA-NPARA Group|Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036793|NCT01235949|FG016|Participant Flow|DPARA-IPARA Group|Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036794|NCT01235949|FG017|Participant Flow|NPARA-IPARA Group|Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036795|NCT01235949|OG000|Outcome|IIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
11036796|NCT01235949|OG001|Outcome|DIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036797|NCT01235949|OG002|Outcome|NIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036798|NCT01235949|OG003|Outcome|IPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036799|NCT01235949|OG004|Outcome|DPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
10848896|NCT00292370|BG000|Baseline|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine~In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
11036800|NCT01235949|OG005|Outcome|NPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036801|NCT01235949|OG000|Outcome|IIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036802|NCT01235949|OG001|Outcome|IIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036803|NCT01235949|OG002|Outcome|IIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11226121|NCT02371876|OG000|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11036804|NCT01235949|OG003|Outcome|DIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036805|NCT01235949|OG004|Outcome|DIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036806|NCT01235949|OG005|Outcome|DIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036807|NCT01235949|OG006|Outcome|NIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036808|NCT01235949|OG007|Outcome|NIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036809|NCT01235949|OG008|Outcome|NIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036810|NCT01235949|OG009|Outcome|IPARA-NPARA Group|Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036811|NCT01235949|OG010|Outcome|DPARA-IPARA Group|Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036812|NCT01235949|OG011|Outcome|NPARA-IPARA Group|Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036813|NCT01235949|EG000|Reported Event|IIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
11036814|NCT01235949|EG001|Reported Event|DIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036815|NCT01235949|EG002|Reported Event|NIBU Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036816|NCT01235949|EG003|Reported Event|IPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036817|NCT01235949|EG004|Reported Event|DPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036818|NCT01235949|EG005|Reported Event|NPARA Group|Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
11036819|NCT01235949|EG006|Reported Event|IIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036820|NCT01235949|EG007|Reported Event|IIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036821|NCT01235949|EG008|Reported Event|IIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
10848897|NCT00292370|BG001|Baseline|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II: Double-blind placebo~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
11036822|NCT01235949|EG009|Reported Event|DIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036823|NCT01235949|EG010|Reported Event|DIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036824|NCT01235949|EG011|Reported Event|DIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036825|NCT01235949|EG012|Reported Event|NIBU-IIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036826|NCT01235949|EG013|Reported Event|NIBU-DIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036827|NCT01235949|EG014|Reported Event|NIBU-NIBU Group|1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036828|NCT01235949|EG015|Reported Event|IPARA-NPARA Group|Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036829|NCT01235949|EG016|Reported Event|DPARA-IPARA Group|Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036830|NCT01235949|EG017|Reported Event|NPARA-IPARA Group|Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
11036831|NCT01235975|BG000|Baseline|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
11036832|NCT01235975|BG001|Baseline|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
11036833|NCT01235975|BG002|Baseline|Total|Total of all reporting groups
11036834|NCT01235975|FG000|Participant Flow|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
10848898|NCT00292370|BG002|Baseline|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II: Double-blind quetiapine~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine in a double-blind fashion."
11036835|NCT01235975|FG001|Participant Flow|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
11036836|NCT01235975|OG000|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
11036837|NCT01235975|OG001|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
11036838|NCT01235975|EG000|Reported Event|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
11036839|NCT01235975|EG001|Reported Event|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
11036840|NCT01236001|BG000|Baseline|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
11036841|NCT01236001|BG001|Baseline|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
11036842|NCT01236001|BG002|Baseline|Total|Total of all reporting groups
11036843|NCT01236001|FG000|Participant Flow|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
11036844|NCT01236001|FG001|Participant Flow|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
11036845|NCT01236001|OG000|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
11036846|NCT01236001|OG001|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
11036847|NCT01236001|OG002|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
11036848|NCT01236001|OG002|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
11036849|NCT01236001|EG000|Reported Event|Vimpat® Treatment|Reported Adverse Events is a combination of both patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
10848899|NCT00292370|BG003|Baseline|Total|Total of all reporting groups
11036850|NCT01236053|BG000|Baseline|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036851|NCT01236053|BG001|Baseline|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036852|NCT01236053|BG002|Baseline|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036853|NCT01236053|BG003|Baseline|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036854|NCT01236053|BG004|Baseline|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036855|NCT01236053|BG005|Baseline|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036856|NCT01236053|BG006|Baseline|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036857|NCT01236053|BG007|Baseline|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036858|NCT01236053|BG008|Baseline|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11226122|NCT02371876|EG000|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11226768|NCT02377817|EG001|Reported Event|Sham PrenaBelt on First Night, PrenaBelt on Second Night|"These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night.~PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.~Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points."
11226769|NCT02377921|BG000|Baseline|Ace-ER 6 g/Day|Ace-ER 6 g/day, divided TID for 48 weeks.
11226770|NCT02377921|BG001|Baseline|Placebo|Matching placebo TID for 48 weeks.
11226771|NCT02377921|BG002|Baseline|Total|Total of all reporting groups
11226772|NCT02377921|FG000|Participant Flow|Ace-ER 6 g/Day|Aceneuramic acid extended-release (Ace-ER) 6 g/day, divided 3 times per day (TID) for 48 weeks.
11226773|NCT02377921|FG001|Participant Flow|Placebo|Matching placebo TID for 48 weeks.
11226774|NCT02377921|OG000|Outcome|Ace-ER 6 g/Day|Ace-ER 6 g/day, divided TID for 48 weeks.
11226775|NCT02377921|OG001|Outcome|Placebo|Matching placebo TID for 48 weeks.
11226776|NCT02377921|EG000|Reported Event|Ace-ER 6 g/Day|Ace-ER 6 g/day, divided TID for 48 weeks.
11226777|NCT02377921|EG001|Reported Event|Placebo|Matching placebo TID for 48 weeks.
11226778|NCT02377947|BG000|Baseline|Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)|Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
11226779|NCT02377947|FG000|Participant Flow|Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)|Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
11226780|NCT02377947|OG000|Outcome|Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)|Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
11226781|NCT02377947|EG000|Reported Event|Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)|Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
11226782|NCT02377986|BG000|Baseline|Experimental: BIT+In-home Decluttering|"Patients who have not received the BIT workshop through our previous study (IRB 6681) will receive BIT+in-home decluttering practice.~BIT+in-home decluterring: BIT Workshop + In-home decluttering practice~In-Home Decluttering: In-home decluttering practice"
11226783|NCT02377986|FG000|Participant Flow|Experimental: BIT+In-home Decluttering|"Patients who have not received the BIT workshop through our previous study (IRB 6681) will receive BIT+in-home decluttering practice.~BIT+in-home decluterring: BIT Workshop + In-home decluttering practice~In-Home Decluttering: In-home decluttering practice"
11226784|NCT02377986|OG000|Outcome|Experimental: BIT+In-home Decluttering|"Patients who have not received the BIT workshop through our previous study (IRB 6681) will receive BIT+in-home decluttering practice.~BIT+in-home decluterring: BIT Workshop + In-home decluttering practice~In-Home Decluttering: In-home decluttering practice"
11226785|NCT02377986|EG000|Reported Event|Experimental: BIT+In-home Decluttering|"Patients who have not received the BIT workshop through our previous study (IRB 6681) will receive BIT+in-home decluttering practice.~BIT+in-home decluterring: BIT Workshop + In-home decluttering practice~In-Home Decluttering: In-home decluttering practice"
11226786|NCT02378025|BG000|Baseline|Yoga Group|"Postures, meditation, breathing exercises~Yoga Group: A 10-week yoga course designed to treat pain."
11226787|NCT02378025|BG001|Baseline|Pain Management Wellness Group|"Behavioral medicine~Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain."
11226788|NCT02378025|BG002|Baseline|Total|Total of all reporting groups
11226789|NCT02378025|FG000|Participant Flow|Yoga Group|"Postures, meditation, breathing exercises~Yoga Group: A 10-week yoga course designed to treat pain."
11226790|NCT02378025|FG001|Participant Flow|Pain Management Wellness Group|"Behavioral medicine~Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain."
11226791|NCT02378025|OG000|Outcome|Yoga Group|"Postures, meditation, breathing exercises~Yoga Group: A 10-week yoga course designed to treat pain."
11226792|NCT02378025|OG001|Outcome|Pain Management Wellness Group|"Behavioral medicine~Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain."
11226793|NCT02378025|EG000|Reported Event|Yoga Group|"Postures, meditation, breathing exercises~Yoga Group: A 10-week yoga course designed to treat pain."
11226794|NCT02378025|EG001|Reported Event|Pain Management Wellness Group|"Behavioral medicine~Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain."
11226795|NCT02378038|BG000|Baseline|PNT2258|PNT2258 administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle.
11226796|NCT02378038|FG000|Participant Flow|PNT2258|PNT2258 administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle.
11226797|NCT02378038|OG000|Outcome|PNT2258|PNT2258 administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle.
11036859|NCT01236053|BG009|Baseline|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036860|NCT01236053|BG010|Baseline|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036861|NCT01236053|BG011|Baseline|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036862|NCT01236053|BG012|Baseline|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036863|NCT01236053|BG013|Baseline|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036864|NCT01236053|BG014|Baseline|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036865|NCT01236053|BG015|Baseline|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036866|NCT01236053|BG016|Baseline|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036867|NCT01236053|BG017|Baseline|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036868|NCT01236053|BG018|Baseline|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036869|NCT01236053|BG019|Baseline|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036870|NCT01236053|BG020|Baseline|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11226123|NCT02371980|BG000|Baseline|Open-label: Vortioxetine 10 mg|Vortioxetine 10 mg, capsules, orally, once, daily (QD) up to 8 weeks. Participants who achieved response (defined as a ≥50% reduction in Montgomery Asberg Depression Rating Scale (MADRS) total score from Baseline) continued to receive vortioxetine 10 mg, capsules, orally, QD for up to Week 16 (stabilization period) in the Open-label Period.
10887305|NCT00499681|BG001|Baseline|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
11036871|NCT01236053|BG021|Baseline|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036872|NCT01236053|BG022|Baseline|Total|Total of all reporting groups
11036873|NCT01236053|FG000|Participant Flow|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036874|NCT01236053|FG001|Participant Flow|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036875|NCT01236053|FG002|Participant Flow|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036876|NCT01236053|FG003|Participant Flow|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036877|NCT01236053|FG004|Participant Flow|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036878|NCT01236053|FG005|Participant Flow|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036879|NCT01236053|FG006|Participant Flow|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036880|NCT01236053|FG007|Participant Flow|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036881|NCT01236053|FG008|Participant Flow|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036882|NCT01236053|FG009|Participant Flow|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11226124|NCT02371980|FG000|Participant Flow|Open-label: Vortioxetine 10 mg|Vortioxetine 10 mg, capsules, orally, once, daily (QD) up to 8 weeks. Participants who achieved response (defined as a ≥50% reduction in Montgomery Asberg Depression Rating Scale (MADRS) total score from Baseline) continued to receive vortioxetine 10 mg, capsules, orally, QD for up to Week 16 (stabilization period) in the Open-label Period.
10887306|NCT00499681|BG002|Baseline|Total|Total of all reporting groups
10848900|NCT00292370|FG000|Participant Flow|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine~In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
11036883|NCT01236053|FG010|Participant Flow|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036884|NCT01236053|FG011|Participant Flow|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036885|NCT01236053|FG012|Participant Flow|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036886|NCT01236053|FG013|Participant Flow|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036887|NCT01236053|FG014|Participant Flow|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036888|NCT01236053|FG015|Participant Flow|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036889|NCT01236053|FG016|Participant Flow|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036890|NCT01236053|FG017|Participant Flow|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036891|NCT01236053|FG018|Participant Flow|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036892|NCT01236053|FG019|Participant Flow|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036893|NCT01236053|FG020|Participant Flow|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036894|NCT01236053|FG021|Participant Flow|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036895|NCT01236053|OG000|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
11036896|NCT01236053|OG001|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036897|NCT01236053|OG000|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
11036898|NCT01236053|OG001|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036899|NCT01236053|OG000|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
11036900|NCT01236053|OG001|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036901|NCT01236053|OG000|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
11036902|NCT01236053|OG001|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036903|NCT01236053|OG001|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice
11036904|NCT01236053|OG000|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
11036905|NCT01236053|OG001|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036906|NCT01236053|OG000|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
11036907|NCT01236053|OG001|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036908|NCT01236053|OG000|Outcome|Cases|Cases
11036909|NCT01236053|OG001|Outcome|Controls|Controls
11036910|NCT01236053|OG000|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
11036911|NCT01236053|OG001|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036912|NCT01236053|OG000|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
11036913|NCT01236053|OG001|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036914|NCT01236053|OG000|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
11036915|NCT01236053|OG001|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036916|NCT01236053|OG000|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
11036917|NCT01236053|OG001|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036918|NCT01236053|OG000|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
11036919|NCT01236053|OG001|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
11036920|NCT01236053|EG000|Reported Event|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036921|NCT01236053|EG001|Reported Event|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036922|NCT01236053|EG002|Reported Event|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036923|NCT01236053|EG003|Reported Event|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036924|NCT01236053|EG004|Reported Event|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036925|NCT01236053|EG005|Reported Event|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036926|NCT01236053|EG006|Reported Event|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036927|NCT01236053|EG007|Reported Event|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036928|NCT01236053|EG008|Reported Event|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036929|NCT01236053|EG009|Reported Event|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036930|NCT01236053|EG010|Reported Event|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036931|NCT01236053|EG011|Reported Event|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11226125|NCT02371980|FG001|Participant Flow|Double-blind: Placebo|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine placebo-matching capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11036932|NCT01236053|EG012|Reported Event|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036933|NCT01236053|EG013|Reported Event|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036934|NCT01236053|EG014|Reported Event|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036935|NCT01236053|EG015|Reported Event|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036936|NCT01236053|EG016|Reported Event|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036937|NCT01236053|EG017|Reported Event|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036938|NCT01236053|EG018|Reported Event|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036939|NCT01236053|EG019|Reported Event|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036940|NCT01236053|EG020|Reported Event|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
11036941|NCT01236053|EG021|Reported Event|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
11036942|NCT01236105|BG000|Baseline|LY2624803|"Participants received each of the following 3 study treatments:~LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.~LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.~LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
11066498|NCT01392573|OG000|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
10848901|NCT00292370|FG001|Participant Flow|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II : Double-blind placebo~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
11226126|NCT02371980|FG002|Participant Flow|Double-blind: Vortioxetine 5 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 5 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226127|NCT02371980|FG003|Participant Flow|Double-blind: Vortioxetine 10 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 10 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226128|NCT02371980|FG004|Participant Flow|Double-blind: Vortioxetine 20 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 20 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226129|NCT02371980|OG000|Outcome|Double-blind: Placebo|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine placebo-matching capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226130|NCT02371980|OG001|Outcome|Double-blind: Vortioxetine 5 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 5 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226131|NCT02371980|OG002|Outcome|Double-blind: Vortioxetine 10 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 10 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226132|NCT02371980|OG003|Outcome|Double-blind: Vortioxetine 20 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 20 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226133|NCT02371980|EG000|Reported Event|Open-label: Vortioxetine 10 mg|Vortioxetine 10 mg, capsules, orally, once, daily (QD) up to 8 weeks. Participants who achieved response (defined as a ≥50% reduction in Montgomery Asberg Depression Rating Scale (MADRS) total score from Baseline) continued to receive vortioxetine 10 mg, capsules, orally, QD for up to Week 16 (stabilization period) in the Open-label Period.
11226134|NCT02371980|EG001|Reported Event|Double-blind: Placebo|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine placebo-matching capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226135|NCT02371980|EG002|Reported Event|Double-blind: Vortioxetine 5 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 5 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226136|NCT02371980|EG003|Reported Event|Double-blind: Vortioxetine 10 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 10 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11226137|NCT02371980|EG004|Reported Event|Double-blind: Vortioxetine 20 mg|Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 20 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
11036943|NCT01236105|FG000|Participant Flow|LY2624803|"Participants received each of the following 3 study treatments:~LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.~LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.~LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
11036944|NCT01236105|OG000|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
11036945|NCT01236105|OG001|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
11036946|NCT01236105|OG002|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
11036947|NCT01236105|EG000|Reported Event|LY2624803 Morning Dosing|LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.
11226798|NCT02378038|EG000|Reported Event|PNT2258|PNT2258 administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle.
11226799|NCT02378207|BG000|Baseline|Group 1 H4:IC31|"15 mcg H4/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.~n=24"
11226800|NCT02378207|BG001|Baseline|Group 2 H56:IC31|"5 mcg H56/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.~n=24"
11226801|NCT02378207|BG002|Baseline|Group 3 BCG (2-8 x 105 CFU)|"Administered ID as 0.1 mL in either deltoid muscle at Day 0.~n=24"
11036948|NCT01236105|EG001|Reported Event|LY2624803 Morning Dosing + Activated Charcoal|LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
11036949|NCT01236105|EG002|Reported Event|LY2624803 Evening Dosing|LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast.
11036950|NCT01236118|BG000|Baseline|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
11036951|NCT01236118|BG001|Baseline|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
11036952|NCT01236118|BG002|Baseline|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44.
11036953|NCT01236118|BG003|Baseline|Total|Total of all reporting groups
11036954|NCT01236118|FG000|Participant Flow|30 mg LY2439821|Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44.
11036955|NCT01236118|FG001|Participant Flow|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
11036956|NCT01236118|FG002|Participant Flow|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
11036957|NCT01236118|OG000|Outcome|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
11036958|NCT01236118|OG001|Outcome|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
11036959|NCT01236118|OG002|Outcome|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
11036960|NCT01236118|EG000|Reported Event|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
11036961|NCT01236118|EG001|Reported Event|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
11036962|NCT01236118|EG002|Reported Event|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
11036963|NCT01236170|BG000|Baseline|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
11036964|NCT01236170|FG000|Participant Flow|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
11036965|NCT01236170|OG000|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
11036966|NCT01236170|EG000|Reported Event|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
11036967|NCT01236196|BG000|Baseline|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
11036968|NCT01236196|BG001|Baseline|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
11036969|NCT01236196|BG002|Baseline|Total|Total of all reporting groups
11036970|NCT01236196|FG000|Participant Flow|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
11036971|NCT01236196|FG001|Participant Flow|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
11036972|NCT01236196|OG000|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
11036973|NCT01236196|OG001|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
11036974|NCT01236196|EG000|Reported Event|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
11036975|NCT01236196|EG001|Reported Event|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
11036976|NCT01236300|BG000|Baseline|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
11036977|NCT01236300|FG000|Participant Flow|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
11036978|NCT01236300|OG000|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
11036979|NCT01236300|OG000|Outcome|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
11036980|NCT01236300|EG000|Reported Event|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
11036981|NCT01236326|BG000|Baseline|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
11036982|NCT01236326|BG001|Baseline|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
11036983|NCT01236326|BG002|Baseline|Total|Total of all reporting groups
11036984|NCT01236326|FG000|Participant Flow|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
11036985|NCT01236326|FG001|Participant Flow|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
11036986|NCT01236326|OG000|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
11036987|NCT01236326|OG001|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
11036988|NCT01236326|EG000|Reported Event|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
11036989|NCT01236326|EG001|Reported Event|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
11036990|NCT01236339|BG000|Baseline|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
11036991|NCT01236339|BG001|Baseline|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
11036992|NCT01236339|BG002|Baseline|Total|Total of all reporting groups
11036993|NCT01236339|FG000|Participant Flow|TIPS|TIPS with GORE® VIATORR® TIPS Endoprosthesis
11036994|NCT01236339|FG001|Participant Flow|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)"
11036995|NCT01236339|OG000|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
11036996|NCT01236339|OG001|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
11036997|NCT01236339|OG000|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis>~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
11036998|NCT01236339|EG000|Reported Event|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
11036999|NCT01236339|EG001|Reported Event|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
11037000|NCT01236352|BG000|Baseline|5 mg Phase I|BMS-911543 5 mg capsule by mouth twice daily
11037001|NCT01236352|BG001|Baseline|10 mg Phase I|BMS-911543 10 mg capsule by mouth twice daily
11037002|NCT01236352|BG002|Baseline|20 mg Phase I|BMS-911543 20 mg capsule by mouth twice daily
11037003|NCT01236352|BG003|Baseline|40 mg Phase I|BMS-911543 40 mg capsule by mouth twice daily
11037004|NCT01236352|BG004|Baseline|80 mg Phase I|BMS-911543 80 mg capsule by mouth twice daily
11037005|NCT01236352|BG005|Baseline|120 mg Phase I|BMS-911543 120 mg capsule by mouth twice daily
11037006|NCT01236352|BG006|Baseline|160 mg Phase I|BMS-911543 160 mg capsule by mouth twice daily
11037007|NCT01236352|BG007|Baseline|200 mg Phase I|BMS-911543 2000 mg capsule by mouth twice daily
11037008|NCT01236352|BG008|Baseline|240 mg Phase I|BMS-911543 240 mg capsule by mouth twice daily
11037009|NCT01236352|BG009|Baseline|120 mg Phase II|BMS-911543 120 mg capsule by mouth twice daily
11037010|NCT01236352|BG010|Baseline|200 mg Phase II|BMS-911543 200 mg capsule by mouth twice daily
11037011|NCT01236352|BG011|Baseline|Total|Total of all reporting groups
11037012|NCT01236352|FG000|Participant Flow|5 mg Phase I|BMS-911543 5 mg capsule by mouth twice daily
11037013|NCT01236352|FG001|Participant Flow|10 mg Phase I|BMS-911543 10 mg capsule by mouth twice daily
11037014|NCT01236352|FG002|Participant Flow|20 mg Phase I|BMS-911543 20 mg capsule by mouth twice daily
11037015|NCT01236352|FG003|Participant Flow|40 mg Phase I|BMS-911543 40 mg capsule by mouth twice daily
11037016|NCT01236352|FG004|Participant Flow|80 mg Phase I|BMS-911543 80 mg capsule by mouth twice daily
11037017|NCT01236352|FG005|Participant Flow|120 mg Phase I|BMS-911543 120 mg capsule by mouth twice daily
11037018|NCT01236352|FG006|Participant Flow|160 mg Phase I|BMS-911543 160 mg capsule by mouth twice daily
11037019|NCT01236352|FG007|Participant Flow|200 mg Phase I|BMS-911543 2000 mg capsule by mouth twice daily
11037020|NCT01236352|FG008|Participant Flow|240 mg Phase I|BMS-911543 240 mg capsule by mouth twice daily
11037021|NCT01236352|FG009|Participant Flow|120 mg Phase II|BMS-911543 120 mg capsule by mouth twice daily
11037022|NCT01236352|FG010|Participant Flow|200 mg Phase II|BMS-911543 200 mg capsule by mouth twice daily
11037023|NCT01236352|OG000|Outcome|5 mg Phase I|BMS-911543 5 mg capsule by mouth twice daily
11037024|NCT01236352|OG001|Outcome|10 mg Phase I|BMS-911543 10 mg capsule by mouth twice daily
11037025|NCT01236352|OG002|Outcome|20 mg Phase I|BMS-911543 20 mg capsule by mouth twice daily
11037026|NCT01236352|OG003|Outcome|40 mg Phase I|BMS-911543 40 mg capsule by mouth twice daily
11037027|NCT01236352|OG004|Outcome|80 mg Phase I|BMS-911543 80 mg capsule by mouth twice daily
11037028|NCT01236352|OG005|Outcome|120 mg Phase I|BMS-911543 120 mg capsule by mouth twice daily
11037029|NCT01236352|OG006|Outcome|160 mg Phase I|BMS-911543 160 mg capsule by mouth twice daily
11037030|NCT01236352|OG007|Outcome|200 mg Phase I|BMS-911543 2000 mg capsule by mouth twice daily
11037031|NCT01236352|OG008|Outcome|240 mg Phase I|BMS-911543 240 mg capsule by mouth twice daily
11037032|NCT01236352|OG009|Outcome|120 mg Phase II|BMS-911543 120 mg capsule by mouth twice daily
11037033|NCT01236352|OG010|Outcome|200 mg Phase II|BMS-911543 200 mg capsule by mouth twice daily
11037034|NCT01236352|EG000|Reported Event|5 mg Phase I|BMS-911543 5 mg capsule by mouth twice daily
11037035|NCT01236352|EG001|Reported Event|10 mg Phase I|BMS-911543 10 mg capsule by mouth twice daily
11037036|NCT01236352|EG002|Reported Event|20 mg Phase I|BMS-911543 20 mg capsule by mouth twice daily
11037037|NCT01236352|EG003|Reported Event|40 mg Phase I|BMS-911543 40 mg capsule by mouth twice daily
11037038|NCT01236352|EG004|Reported Event|80 mg Phase I|BMS-911543 80 mg capsule by mouth twice daily
11037039|NCT01236352|EG005|Reported Event|120 mg Phase I|BMS-911543 120 mg capsule by mouth twice daily
11037040|NCT01236352|EG006|Reported Event|160 mg Phase I|BMS-911543 160 mg capsule by mouth twice daily
11037041|NCT01236352|EG007|Reported Event|200 mg Phase I|BMS-911543 2000 mg capsule by mouth twice daily
11037042|NCT01236352|EG008|Reported Event|240 mg Phase I|BMS-911543 240 mg capsule by mouth twice daily
11037043|NCT01236352|EG009|Reported Event|120 mg Phase II|BMS-911543 120 mg capsule by mouth twice daily
11037044|NCT01236352|EG010|Reported Event|200 mg Phase II|BMS-911543 200 mg capsule by mouth twice daily
11037045|NCT01236365|BG000|Baseline|Atorvastatin|Atorvastatin: 10 or 20 mg daily
11037046|NCT01236365|BG001|Baseline|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
11037047|NCT01236365|BG002|Baseline|Total|Total of all reporting groups
11037048|NCT01236365|FG000|Participant Flow|Atorvastatin|Atorvastatin: 10 or 20 mg daily
11037049|NCT01236365|FG001|Participant Flow|Placebo|Placebo: 10 or 20 mg daily
11037050|NCT01236365|OG000|Outcome|Atorvastatin LDL-C at Randomization|
11037051|NCT01236365|OG001|Outcome|Atorvastatin LDL-C at 6 Months|
11037052|NCT01236365|OG002|Outcome|Placebo LDL-C at Randomization|
11037053|NCT01236365|OG003|Outcome|Placebo LDL-C at 6 Months|
11037054|NCT01236365|OG000|Outcome|Atorvastatin hsCRP at Randomization|
11037055|NCT01236365|OG001|Outcome|Atorvastatin hsCRP at 6 Months|
11037056|NCT01236365|OG002|Outcome|Placebo hsCRP at Randomization|
11037057|NCT01236365|OG003|Outcome|Placebo hsCRP at 6 Months|
11037058|NCT01236365|OG000|Outcome|Atorvastatin MAGE at Randomization|
11037059|NCT01236365|OG001|Outcome|Atorvastatin MAGE at 6 Months|
11037060|NCT01236365|OG002|Outcome|Placebo MAGE at Randomization|
11037061|NCT01236365|OG003|Outcome|Placebo MAGE at 6 Months|
11037062|NCT01236365|OG000|Outcome|Atorvastatin at Randomization|
11037063|NCT01236365|OG001|Outcome|Placebo at Randomization|
11037064|NCT01236365|EG000|Reported Event|Atorvastatin|Atorvastatin: 10 or 20 mg daily
11037065|NCT01236365|EG001|Reported Event|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
11037066|NCT01236378|BG000|Baseline|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
11037067|NCT01236378|FG000|Participant Flow|Sirolimus|Sirolimus, 1 milligram (mg) tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last pharmacokinetic (PK) sample collection.
11037068|NCT01236378|OG000|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
11037069|NCT01236378|EG000|Reported Event|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
11037070|NCT01236391|BG000|Baseline|PCI-32765|PCI-32765: 560 mg daily
11037071|NCT01236391|FG000|Participant Flow|PCI-32765|Participants received 560 mg daily
11037072|NCT01236391|OG000|Outcome|PCI-32765|PCI-32765: 560 mg daily
11037073|NCT01236391|OG000|Outcome|PCI-32765 - Day 8|PCI-32765: 560 mg daily
11037074|NCT01236391|OG001|Outcome|PCI-45227 (Metabolite)- Day 8|PCI-32765: 560 mg daily
11037075|NCT01236391|OG000|Outcome|EORTC QLQ-C30|Participants received PCI-32765 560 mg daily and completed the EORTC QLQ-C30 questionnaire at Pre-Dose and at Cycle 5
11037076|NCT01236391|EG000|Reported Event|PCI-32765|PCI-32765: 560 mg daily
11037077|NCT01236534|BG000|Baseline|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
11037078|NCT01236534|BG001|Baseline|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
11037079|NCT01236534|BG002|Baseline|Total|Total of all reporting groups
11037080|NCT01236534|FG000|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
11037081|NCT01236534|FG001|Participant Flow|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
11037082|NCT01236534|OG000|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
11037083|NCT01236534|OG001|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
11037084|NCT01236534|EG000|Reported Event|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
11037085|NCT01236534|EG001|Reported Event|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
11037086|NCT01236573|BG000|Baseline|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037087|NCT01236573|BG001|Baseline|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037088|NCT01236573|BG002|Baseline|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037089|NCT01236573|BG003|Baseline|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037090|NCT01236573|BG004|Baseline|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037091|NCT01236573|BG005|Baseline|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037092|NCT01236573|BG006|Baseline|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
10848902|NCT00292370|FG002|Participant Flow|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II : Double-blind quetiapine~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine for 8 weeks in a double-blind fashion."
11037093|NCT01236573|BG007|Baseline|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037094|NCT01236573|BG008|Baseline|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037095|NCT01236573|BG009|Baseline|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11226802|NCT02378207|BG003|Baseline|Group 4 Control Sodium Chloride 0.9%|"Administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.~n=24"
11226803|NCT02378207|BG004|Baseline|Total|Total of all reporting groups
11226804|NCT02378207|FG000|Participant Flow|Group 1 H4:IC31|15 mcg H4/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.
11037096|NCT01236573|BG010|Baseline|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037097|NCT01236573|BG011|Baseline|Total|Total of all reporting groups
11037098|NCT01236573|FG000|Participant Flow|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037099|NCT01236573|FG001|Participant Flow|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037100|NCT01236573|FG002|Participant Flow|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037101|NCT01236573|FG003|Participant Flow|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037102|NCT01236573|FG004|Participant Flow|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037103|NCT01236573|FG005|Participant Flow|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037104|NCT01236573|FG006|Participant Flow|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037105|NCT01236573|FG007|Participant Flow|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037106|NCT01236573|FG008|Participant Flow|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037107|NCT01236573|FG009|Participant Flow|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
10848903|NCT00292370|OG000|Outcome|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Placebo: Double-blind placebo taken with OL paroxetine"
11037108|NCT01236573|FG010|Participant Flow|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037109|NCT01236573|OG000|Outcome|All Phase I Participants|All phase I participants who received at least one dose intravenously of CD8 + TIL expressing IL-12 in Groups 1-4, and Bulk TIL expressing IL-12 in Groups 5-10 (i.e., CD8 + TIL expressing IL-12 1x10^6, CD8 + TIL expressing IL-12 3x10^6, CD8 + TIL expressing IL-12 3x10^7, CD8 + TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^7, Bulk TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^8, Bulk TIL expressing IL-12 3x10^8, Bulk TIL expressing IL-12 1x10^9, and Bulk TIL expressing IL-12 3x10^9) respectively.
11037110|NCT01236573|OG000|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037111|NCT01236573|OG001|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037112|NCT01236573|OG002|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037113|NCT01236573|OG003|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037114|NCT01236573|OG004|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037115|NCT01236573|OG005|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037116|NCT01236573|OG006|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037117|NCT01236573|OG007|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037118|NCT01236573|OG008|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11226805|NCT02378207|FG001|Participant Flow|Group 2 H56:IC31|5 mcg H56/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.
11226806|NCT02378207|FG002|Participant Flow|Group 3 BCG (2-8 x 105 CFU)|Administered ID as 0.1 mL in either deltoid muscle at Day 0.
11226807|NCT02378207|FG003|Participant Flow|Group 4 Control Sodium Chloride 0.9%|Administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.
11226808|NCT02378207|OG000|Outcome|Group 1 H4:IC31|15 mcg H4/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.
11037119|NCT01236573|OG009|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037120|NCT01236573|OG010|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037121|NCT01236573|EG000|Reported Event|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037122|NCT01236573|EG001|Reported Event|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037123|NCT01236573|EG002|Reported Event|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037124|NCT01236573|EG003|Reported Event|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037125|NCT01236573|EG004|Reported Event|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037126|NCT01236573|EG005|Reported Event|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037127|NCT01236573|EG006|Reported Event|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037128|NCT01236573|EG007|Reported Event|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11226138|NCT02372006|BG000|Baseline|Dose Finding - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11226809|NCT02378207|OG001|Outcome|Group 2 H56:IC31|5 mcg H56/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.
11037129|NCT01236573|EG008|Reported Event|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037130|NCT01236573|EG009|Reported Event|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037131|NCT01236573|EG010|Reported Event|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
11037132|NCT01236742|BG000|Baseline|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
11037133|NCT01236742|BG001|Baseline|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
11037134|NCT01236742|BG002|Baseline|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
11037135|NCT01236742|BG003|Baseline|Total|Total of all reporting groups
11037136|NCT01236742|FG000|Participant Flow|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
11037137|NCT01236742|FG001|Participant Flow|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
11037138|NCT01236742|FG002|Participant Flow|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
11037139|NCT01236742|OG000|Outcome|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
11037140|NCT01236742|OG001|Outcome|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
11037141|NCT01236742|OG002|Outcome|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
11037142|NCT01236742|EG000|Reported Event|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
11037143|NCT01236742|EG001|Reported Event|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
11037144|NCT01236742|EG002|Reported Event|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
11037145|NCT01236755|BG000|Baseline|Subjects Completed the 14-month Study|Subjects who have completed the study in which they used single-vision spectacles every day for 7 months in Phase I and ortho-k lenses every night for the next 7 months in Phase II to correct their vision.
11037146|NCT01236755|FG000|Participant Flow|Subjects in Spectacle and Ortho-k Wearing Phases|Subjects enrolled in the study during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
11037147|NCT01236755|OG000|Outcome|Axial Elongation in Spectacle and Ortho-k Wearing Phases|Axial elongation in children during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
11226810|NCT02378207|OG002|Outcome|Group 3 BCG (2-8 x 105 CFU)|Administered ID as 0.1 mL in either deltoid muscle at Day 0.
11037148|NCT01236755|OG000|Outcome|Serious Adverse Events in Spectacle and Ortho-k Wearing Phases|Number of subjects with serious adverse events in the cornea and conjunctiva during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
11037149|NCT01236755|EG000|Reported Event|Serious Adverse Events in Spectacle and Ortho-k Wearing Phase|Number of subjects with serious adverse events of the cornea and conjunctiva during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
11037150|NCT01236768|BG000|Baseline|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
11037151|NCT01236768|BG001|Baseline|Levora|hormonal oral contraceptive
11037152|NCT01236768|BG002|Baseline|Total|Total of all reporting groups
11037153|NCT01236768|FG000|Participant Flow|AG200-15|Transdermal contraceptive delivery system (TCDS)
11037154|NCT01236768|FG001|Participant Flow|Levora|hormonal oral contraceptive
11037155|NCT01236768|OG000|Outcome|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
11037156|NCT01236768|OG001|Outcome|Levora|hormonal oral contraceptive
11037157|NCT01236768|OG001|Outcome|Levora|"oral contraceptive containing 150mcg of LNG and 30mcg of EE~Levora: One tablet of Levora will be taken each day for a 28 day cycle."
11037158|NCT01236768|EG000|Reported Event|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
11037159|NCT01236768|EG001|Reported Event|Levora|"oral contraceptive containing 150mcg of LNG and 30mcg of EE~Levora: One tablet of Levora will be taken each day for a 28 day cycle."
11037160|NCT01237041|BG000|Baseline|Niacin First|"Subjects receive niacin on day 1 then cross over to receive placebo on day 2.~Niacin: 500 mg po four times on one of the inpatient days~Placebo"
11037161|NCT01237041|BG001|Baseline|Placebo First|"Subjects receive placebo on day 1 then cross over to receive niacin on day 2~Niacin: 500 mg po four times on one of the inpatient days~Placebo"
11037162|NCT01237041|BG002|Baseline|Dose-Establishing Study 1 Niacin 250mg|Niacin 250mg x 3 doses 2 hours apart at 6AM, 8AM, and 10AM
11037163|NCT01237041|BG003|Baseline|Dose-Establishing Study 1 Niacin 500mg|Niacin 500mg x 3 doses 2 hours apart 6AM, 8AM, and 10AM
11037164|NCT01237041|BG004|Baseline|Dose-Establishing Study 2 Niacin 500mg|Niacin 500mg x 4 doses 1 hours apart 7:30AM, 8:30AM, 9:30AM, and 10:30AM
11037165|NCT01237041|BG005|Baseline|Total|Total of all reporting groups
11037166|NCT01237041|FG000|Participant Flow|Niacin First|"Subjects receive niacin on day 1 then cross over to receive placebo on day 2.~Niacin: 500 mg po four times on one of the inpatient day~Placebo po four times on the next inpatient day"
11037167|NCT01237041|FG001|Participant Flow|Placebo First|"Subjects receive placebo on day 1 then cross over to receive niacin on day 2~Placebo po four times on an inpatient day Niacin: 500 mg po four times on the next inpatient day"
11037168|NCT01237041|FG002|Participant Flow|Dose-Establishing Study 1 Niacin 250mg|Subjects received Niacin 250 mg every 2 hours for 3 doses (at 6am, 8am, and 10am).
11037169|NCT01237041|FG003|Participant Flow|Dose-Establishing Study 1 Niacin 500mg|Subjects received Niacin 500 mg every 2 hours for 3 doses (at 6am, 8am, and 10am).
11037170|NCT01237041|FG004|Participant Flow|Dose-Establishing Study 2 Niacin 500mg|Subjects received Niacin 500 mg hourly for 4 doses (administered at 7:30am, 8:30am, 9:30am, and 10:30am).
11037171|NCT01237041|OG000|Outcome|All Randomized Subjects|Results of both randomization orders to assess effect of niacin
11037172|NCT01237041|OG001|Outcome|Dose-Establishing Study 1 Niacin 250mg|Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
11037173|NCT01237041|OG002|Outcome|Dose-Establishing Study 1 Niacin 500mg|Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
11037174|NCT01237041|OG003|Outcome|Dose-Establishing Study 2 Niacin 500mg|Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
11037175|NCT01237041|EG000|Reported Event|All Randomized Subjects|Results of both randomization orders to assess effect of Niacin 500mg every 1 hour for 4 doses
11037176|NCT01237041|EG001|Reported Event|Dose-Finding Study 1 Niacin 250mg|Results from Niacin 250mg every 2 hours for 3 doses
11037177|NCT01237041|EG002|Reported Event|Dose-Finding Study 1 Niacin 500mg|Results from Niacin 500mg every 2 hours for 3 doses
11037178|NCT01237041|EG003|Reported Event|Dose-Finding Study 2 Niacin 500mg|Results from Niacin 500mg every 1 hour for 4 doses
11037179|NCT01237054|BG000|Baseline|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
11066499|NCT01392573|OG001|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11226811|NCT02378207|OG003|Outcome|Group 4 Control Sodium Chloride 0.9%|Administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.
11226812|NCT02378207|EG000|Reported Event|Group 1 H4:IC31|"15 mcg H4/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.~H4:IC31"
11037180|NCT01237054|FG000|Participant Flow|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
11037181|NCT01237054|OG000|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
11037182|NCT01237054|OG001|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
11037183|NCT01237054|OG002|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
11037184|NCT01237054|OG001|Outcome|SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. Multiple myeloma is a plasma cell neoplasm.
11037185|NCT01237054|EG000|Reported Event|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
11037186|NCT01237080|BG000|Baseline|Fastrach|50 persons beeing intubated using the Fastrach.
11037187|NCT01237080|BG001|Baseline|GlideScope|50 persons beeing intubated using the GlideScope.
11037188|NCT01237080|BG002|Baseline|Total|Total of all reporting groups
11037189|NCT01237080|FG000|Participant Flow|Fastrach|50 persons beeing intubated using the Fastrach.
11037190|NCT01237080|FG001|Participant Flow|GlideScope|50 persons beeing intubated using the GlideScope.
11037191|NCT01237080|OG000|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
11037192|NCT01237080|OG001|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
11037193|NCT01237080|EG000|Reported Event|Fastrach|50 persons beeing intubated using the Fastrach.
11037194|NCT01237080|EG001|Reported Event|GlideScope|50 persons beeing intubated using the GlideScope.
11037195|NCT01237197|BG000|Baseline|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
11037196|NCT01237197|BG001|Baseline|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
11037197|NCT01237197|BG002|Baseline|Total|Total of all reporting groups
11037198|NCT01237197|FG000|Participant Flow|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
11037199|NCT01237197|FG001|Participant Flow|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
11037200|NCT01237197|OG000|Outcome|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
11037201|NCT01237197|OG001|Outcome|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
11037202|NCT01237197|EG000|Reported Event|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
11037203|NCT01237197|EG001|Reported Event|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
11037204|NCT01237223|BG000|Baseline|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
11226813|NCT02378207|EG001|Reported Event|Group 2 H56:IC31|"5 mcg H56/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.~H56:IC31"
11037205|NCT01237223|BG001|Baseline|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
11037206|NCT01237223|BG002|Baseline|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
11037207|NCT01237223|BG003|Baseline|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
11037208|NCT01237223|BG004|Baseline|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
11037209|NCT01237223|BG005|Baseline|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
11037210|NCT01237223|BG006|Baseline|Total|Total of all reporting groups
11037211|NCT01237223|FG000|Participant Flow|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
11037212|NCT01237223|FG001|Participant Flow|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
11037213|NCT01237223|FG002|Participant Flow|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
11037214|NCT01237223|FG003|Participant Flow|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
11037215|NCT01237223|FG004|Participant Flow|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
11037216|NCT01237223|FG005|Participant Flow|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
11037217|NCT01237223|OG000|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
11037218|NCT01237223|OG001|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
11037219|NCT01237223|OG002|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
11037220|NCT01237223|OG003|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
11037221|NCT01237223|OG004|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
11226814|NCT02378207|EG002|Reported Event|Group 3 BCG (2-8 x 105 CFU)|"Administered ID as 0.1 mL in either deltoid muscle at Day 0.~BCG"
11226815|NCT02378207|EG003|Reported Event|Group 4 Control Sodium Chloride 0.9%|"Administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56.~Control Sodium Chloride 0.9%"
11037222|NCT01237223|OG005|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
11037223|NCT01237223|OG000|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
11037224|NCT01237223|EG000|Reported Event|Placebo (Double Blind)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
11037225|NCT01237223|EG001|Reported Event|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
11037226|NCT01237223|EG002|Reported Event|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
11037227|NCT01237223|EG003|Reported Event|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
11037228|NCT01237223|EG004|Reported Event|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
11037229|NCT01237223|EG005|Reported Event|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
11037230|NCT01237223|EG006|Reported Event|Placebo (Single-Blind run-in Period)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in period (4 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
11037231|NCT01237301|BG000|Baseline|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037232|NCT01237301|BG001|Baseline|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037233|NCT01237301|BG002|Baseline|Total|Total of all reporting groups
11037234|NCT01237301|FG000|Participant Flow|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037235|NCT01237301|FG001|Participant Flow|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037236|NCT01237301|OG000|Outcome|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037237|NCT01237301|OG001|Outcome|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037238|NCT01237301|OG000|Outcome|CGM Group|"Wear an unblinded CGM for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use real time continuous glucose monitoring (rt CGM).~CGM Group: Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037239|NCT01237301|OG001|Outcome|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use structured self monitoring blood glucose (stSMBG) and periodic, blinded continuous glucose monitoring (CGM).~SMBG Group: Fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes. Used CGM blinded once every four weeks."
11037240|NCT01237301|EG000|Reported Event|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037241|NCT01237301|EG001|Reported Event|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
11037242|NCT01237327|BG000|Baseline|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
11037243|NCT01237327|BG001|Baseline|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
11037244|NCT01237327|BG002|Baseline|Total|Total of all reporting groups
11037245|NCT01237327|FG000|Participant Flow|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
11037246|NCT01237327|FG001|Participant Flow|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
11037247|NCT01237327|OG000|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
11037248|NCT01237327|OG001|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
11037249|NCT01237327|EG000|Reported Event|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
11037250|NCT01237327|EG001|Reported Event|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
11037251|NCT01237340|BG000|Baseline|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
11037252|NCT01237340|FG000|Participant Flow|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
11037253|NCT01237340|OG000|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
11037254|NCT01237340|OG000|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
11037255|NCT01237340|OG001|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
11037256|NCT01237340|OG001|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
11037257|NCT01237340|EG000|Reported Event|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
11037258|NCT01237353|BG000|Baseline|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
11226816|NCT02378220|BG000|Baseline|"Controls (Not Tested)"|Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)
11037259|NCT01237353|FG000|Participant Flow|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
11226817|NCT02378220|BG001|Baseline|"Intervention (Tested)"|"Patients in the tested group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.~Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System"
11226818|NCT02378220|BG002|Baseline|Total|Total of all reporting groups
11226819|NCT02378220|FG000|Participant Flow|"Controls (Not Tested)"|Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)
11037260|NCT01237353|OG000|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
11037261|NCT01237353|EG000|Reported Event|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
11037262|NCT01237587|BG000|Baseline|Duloxetine|"Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).~Participants who received higher doses of Duloxetine in acute & extension phase received gradually lower doses of duloxetine & participants on lower doses of Duloxetine in acute phase received placebo during 1-week tapering phase."
11037263|NCT01237587|BG001|Baseline|Placebo|"Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).~Participants who received placebo in acute phase received placebo & participants who received higher doses of Duloxetine in extension phase received gradually lower doses of duloxetine during 1-week tapering phase."
11037264|NCT01237587|BG002|Baseline|Total|Total of all reporting groups
11037265|NCT01237587|FG000|Participant Flow|Duloxetine/Duloxetine|"Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).~Participants who received higher doses of Duloxetine in acute & extension phase received gradually lower doses of duloxetine & participants on lower doses of Duloxetine in acute phase received placebo during 1-week tapering phase."
11037266|NCT01237587|FG001|Participant Flow|Placebo/Duloxetine|"Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).~Participants who received placebo in acute phase received placebo & participants who received higher doses of Duloxetine in extension phase received gradually lower doses of duloxetine during1-week tapering phase."
11037267|NCT01237587|OG000|Outcome|Duloxetine - Acute|Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
11037268|NCT01237587|OG001|Outcome|Placebo - Acute|Participants received Placebo orally once daily (QD) for 13 weeks.
11037269|NCT01237587|OG000|Outcome|Duloxetine/Duloxetine - Extension|Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment phase.
11037270|NCT01237587|OG000|Outcome|Duloxetine/Duloxetine - Extension Phase|Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
11037271|NCT01237587|OG001|Outcome|Placebo/Duloxetine - Extension Phase|Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
11037272|NCT01237587|EG000|Reported Event|Duloxetine - Acute|Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks during Acute phase.
11037273|NCT01237587|EG001|Reported Event|Placebo - Acute|Participants received Placebo orally once daily (QD) for 13 weeks during Acute phase.
11037274|NCT01237587|EG002|Reported Event|Duloxetine/Duloxetine - Extension|Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
11037275|NCT01237587|EG003|Reported Event|Placebo/Duloxetine - Extension|Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
11037276|NCT01237587|EG004|Reported Event|Duloxetine 60/Duloxetine 30 - Taper|Participants who received 60mg Duloxetine in acute & extension phase received 30mg of Duloxetine in taper phase.
11037277|NCT01237587|EG005|Reported Event|Placebo/Placebo - Taper|Participants who received placebo or 30mg Duloxetine in acute phase received placebo in Taper phase.
11226820|NCT02378220|FG001|Participant Flow|"Intervention (Tested)"|"Patients in the tested group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.~Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System"
11037278|NCT01237678|BG000|Baseline|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037279|NCT01237678|BG001|Baseline|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037280|NCT01237678|BG002|Baseline|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
11037281|NCT01237678|BG003|Baseline|Total|Total of all reporting groups
11037282|NCT01237678|FG000|Participant Flow|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037283|NCT01237678|FG001|Participant Flow|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D (recommended phase II dose) determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037284|NCT01237678|FG002|Participant Flow|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
11037285|NCT01237678|OG000|Outcome|IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2|
11037286|NCT01237678|OG001|Outcome|IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2|
11037287|NCT01237678|OG002|Outcome|IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2|
11037288|NCT01237678|OG003|Outcome|IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2|
11037289|NCT01237678|OG004|Outcome|IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2|
11226821|NCT02378220|OG000|Outcome|"Controls (Not Tested)"|Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)
11037290|NCT01237678|OG000|Outcome|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037291|NCT01237678|OG000|Outcome|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037292|NCT01237678|OG001|Outcome|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037293|NCT01237678|OG002|Outcome|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
11037294|NCT01237678|OG001|Outcome|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
11037295|NCT01237678|EG000|Reported Event|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037296|NCT01237678|EG001|Reported Event|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
11037297|NCT01237678|EG002|Reported Event|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
11037298|NCT01237821|BG000|Baseline|BenzaClin|"Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.~BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks"
11037299|NCT01237821|BG001|Baseline|Effaclar|"Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.~Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks"
11037300|NCT01237821|BG002|Baseline|Total|Total of all reporting groups
11037301|NCT01237821|FG000|Participant Flow|BenzaClin|"Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.~BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks"
11037302|NCT01237821|FG001|Participant Flow|Effaclar|"Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.~Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks"
11037303|NCT01237821|OG000|Outcome|Effaclar|Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
11037304|NCT01237821|OG001|Outcome|Benzaclin|BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
11037305|NCT01237821|EG000|Reported Event|Effaclar|"Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.~Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks"
11037306|NCT01237821|EG001|Reported Event|BenzaClin|"Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.~BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks"
11037307|NCT01237899|BG000|Baseline|1 mg LY2623091 First Then 25 mg LY2623091|1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
11037308|NCT01237899|BG001|Baseline|1 mg LY2623091 First Then Placebo|1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
11037309|NCT01237899|BG002|Baseline|1 mg LY2623091 First Then 50 mg Eplerenone|1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
11037310|NCT01237899|BG003|Baseline|50 mg Eplerenone First Then 25 mg LY2623091|50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
11037311|NCT01237899|BG004|Baseline|50 mg Eplerenone First Then Placebo|50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
11037312|NCT01237899|BG005|Baseline|Placebo First Then 25 mg LY2623091|Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
10848904|NCT00292370|OG001|Outcome|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Quetiapine: Double-blind quetiapine taken with OL paroxetine"
11037313|NCT01237899|BG006|Baseline|10 mg LY2623091 First Then 0.3 mg LY2623091|10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before 0.3 mg LY2623091 daily by mouth for 7 days.
11037314|NCT01237899|BG007|Baseline|10 mg LY2623091 First Then Placebo|10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
11037315|NCT01237899|BG008|Baseline|10 mg LY2623091 First Then 50 mg Eplerenone|10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
11037316|NCT01237899|BG009|Baseline|50 mg Eplerenone First Then 0.3 mg LY2623091|50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
11037317|NCT01237899|BG010|Baseline|Placebo Then 0.3 mg LY2623091|Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
11037318|NCT01237899|BG011|Baseline|Total|Total of all reporting groups
11037319|NCT01237899|FG000|Participant Flow|1 mg LY2623091 First Then 25 mg LY2623091|1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
11037320|NCT01237899|FG001|Participant Flow|1 mg LY2623091 First Then Placebo|1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
11037321|NCT01237899|FG002|Participant Flow|1 mg LY2623091 First Then 50 mg Eplerenone|1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
11037322|NCT01237899|FG003|Participant Flow|50 mg Eplerenone First Then 25 mg LY2623091|50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
11037323|NCT01237899|FG004|Participant Flow|50 mg Eplerenone First Then Placebo|50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
11037324|NCT01237899|FG005|Participant Flow|Placebo First Then 25 mg LY2623091|Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
11037325|NCT01237899|FG006|Participant Flow|10 mg LY2623091 First Then 0.3 mg LY2623091|10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before 0.3 mg LY2623091 daily by mouth for 7 days.
11037326|NCT01237899|FG007|Participant Flow|10 mg LY2623091 First Then Placebo|10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
11037327|NCT01237899|FG008|Participant Flow|10 mg LY2623091 First Then 50 mg Eplerenone|10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
11037328|NCT01237899|FG009|Participant Flow|50 mg Eplerenone First Then 0.3 mg LY2623091|50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
11037329|NCT01237899|FG010|Participant Flow|Placebo Then 0.3 mg LY2623091|Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
11037330|NCT01237899|OG000|Outcome|Placebo|Daily by mouth for 7 days.
11037331|NCT01237899|OG001|Outcome|0.3 mg LY2623091|Daily by mouth for 7 days.
11037332|NCT01237899|OG002|Outcome|1 mg LY2623091|Daily by mouth for 7 days.
11037333|NCT01237899|OG003|Outcome|10 mg LY2623091|Daily by mouth for 7 days.
11037334|NCT01237899|OG004|Outcome|25 mg LY2623091|Daily by mouth for 7 days.
11037335|NCT01237899|OG005|Outcome|50 mg Eplerenone|Daily by mouth for 7 days.
11037336|NCT01237899|OG000|Outcome|0.3 mg LY2623091|Daily by mouth for 7 days.
11037337|NCT01237899|OG001|Outcome|1 mg LY2623091|Daily by mouth for 7 days.
11037338|NCT01237899|OG002|Outcome|10 mg LY2623091|Daily by mouth for 7 days.
11037339|NCT01237899|OG003|Outcome|25 mg LY2623091|Daily by mouth for 7 days.
11037340|NCT01237899|EG000|Reported Event|Placebo|Daily by mouth for 7 days.
11037341|NCT01237899|EG001|Reported Event|0.3 mg LY2623091|Daily by mouth for 7 days.
11037342|NCT01237899|EG002|Reported Event|1 mg LY2623091|Daily by mouth for 7 days.
11037343|NCT01237899|EG003|Reported Event|10 mg LY2623091|Daily by mouth for 7 days.
11037344|NCT01237899|EG004|Reported Event|25 mg LY2623091|Daily by mouth for 7 days.
11037345|NCT01237899|EG005|Reported Event|50 mg Eplerenone|Daily by mouth for 7 days.
11037346|NCT01237951|BG000|Baseline|Gemcitabine/Busulfan/Melphalan|Patients ages 18-70 with primary refractory or relapsed myeloma, candidates for an autologous SCT (ASCT) who had previously received treatment with bortezomib, an immunomodulatory drug, or both, or who were receiving a salvage ASCT.
11037347|NCT01237951|FG000|Participant Flow|Gemcitabine/Busulfan/Melphalan|Patients ages 18-70 with primary refractory or relapsed myeloma, candidates for an autologous SCT (ASCT) who had previously received treatment with bortezomib, an immunomodulatory drug, or both, or who were receiving a salvage ASCT.
11037348|NCT01237951|OG000|Outcome|Gemcitabine/Busulfan/Melphalan|Patients with refractory or relapsed myeloma received high-dose GemBuMel with ASCT
11037349|NCT01237951|EG000|Reported Event|Gemcitabine/Busulfan/Melphalan|Participants with refractory or relapsed myeloma received high-dose GemBuMel with ASCT.
11037350|NCT01238120|BG000|Baseline|Placebo and Home-Based Exercise|"200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.~Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period~Placebo: 200mg BID and 8 hours apart"
11037351|NCT01238120|BG001|Baseline|Placebo|"200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.~Placebo: 200mg BID and 8 hours apart"
11037352|NCT01238120|BG002|Baseline|Ibuprofen 200mg BID, Home-Based Exercise|"200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.~Ibuprofen: 200 mg BID and 8 hours apart~Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period"
11037353|NCT01238120|BG003|Baseline|Ibuprofen 200 mg BID|"200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.~Ibuprofen: 200 mg BID and 8 hours apart"
11037354|NCT01238120|BG004|Baseline|Total|Total of all reporting groups
11037355|NCT01238120|FG000|Participant Flow|Placebo and Home-Based Exercise|"200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.~Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period~Placebo: 200mg BID and 8 hours apart"
11037356|NCT01238120|FG001|Participant Flow|Placebo|"200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.~Placebo: 200mg BID and 8 hours apart"
11037357|NCT01238120|FG002|Participant Flow|Ibuprofen 200mg BID, Home-Based Exercise|"200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.~Ibuprofen: 200 mg BID and 8 hours apart~Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period"
11037358|NCT01238120|FG003|Participant Flow|Ibuprofen 200 mg BID|"200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.~Ibuprofen: 200 mg BID and 8 hours apart"
11037359|NCT01238120|OG000|Outcome|Placebo and Home-Based Exercise|"200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.~Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period~Placebo: 200mg BID and 8 hours apart"
11037360|NCT01238120|OG001|Outcome|Placebo|"200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.~Placebo: 200mg BID and 8 hours apart"
11037361|NCT01238120|OG002|Outcome|Ibuprofen 200mg BID, Home-Based Exercise|"200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.~Ibuprofen: 200 mg BID and 8 hours apart~Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period"
11037362|NCT01238120|OG003|Outcome|Ibuprofen 200 mg BID|"200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.~Ibuprofen: 200 mg BID and 8 hours apart"
11037363|NCT01238120|EG000|Reported Event|Placebo and Home-Based Exercise|"200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.~Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period~Placebo: 200mg BID and 8 hours apart"
11037364|NCT01238120|EG001|Reported Event|Placebo|"200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.~Placebo: 200mg BID and 8 hours apart"
11037365|NCT01238120|EG002|Reported Event|Ibuprofen 200mg BID, Home-Based Exercise|"200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.~Ibuprofen: 200 mg BID and 8 hours apart~Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period"
11037366|NCT01238120|EG003|Reported Event|Ibuprofen 200 mg BID|"200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.~Ibuprofen: 200 mg BID and 8 hours apart"
11037367|NCT01238172|BG000|Baseline|Arm A - MEAL Program Intervention|Patients will receive dietary education and telephone counseling sessions over 24 months.
11037368|NCT01238172|BG001|Baseline|Arm B - Prostate Cancer Foundation Booklet|Patients receive education material about diet, nutrition, exercise and cancer.
11037369|NCT01238172|BG002|Baseline|Total|Total of all reporting groups
11037370|NCT01238172|FG000|Participant Flow|Arm A - MEAL Program Intervention|Patients will receive dietary education and telephone counseling sessions over 24 months.
11037371|NCT01238172|FG001|Participant Flow|Arm B - Prostate Cancer Foundation Booklet|Patients receive education material about diet, nutrition, exercise and cancer.
11037372|NCT01238172|OG000|Outcome|Arm A - MEAL Program Intervention|Patients will receive dietary education and telephone counseling sessions over 24 months.
11037373|NCT01238172|OG001|Outcome|Arm B - Prostate Cancer Foundation Booklet|Patients receive education material about diet, nutrition, exercise and cancer.
11037374|NCT01238172|EG000|Reported Event|Arm A - MEAL Program Intervention|Patients will receive dietary education and telephone counseling sessions over 24 months.
11037375|NCT01238172|EG001|Reported Event|Arm B - Prostate Cancer Foundation Booklet|Patients receive education material about diet, nutrition, exercise and cancer.
11037376|NCT01238341|BG000|Baseline|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
11037377|NCT01238341|FG000|Participant Flow|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
11037378|NCT01238341|OG000|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
11037379|NCT01238341|EG000|Reported Event|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
11066500|NCT01392573|EG000|Reported Event|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
11037380|NCT01238471|BG000|Baseline|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
11037381|NCT01238471|BG001|Baseline|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
11037382|NCT01238471|BG002|Baseline|Total|Total of all reporting groups
11037383|NCT01238471|FG000|Participant Flow|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
11037384|NCT01238471|FG001|Participant Flow|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
11037385|NCT01238471|OG000|Outcome|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
11037386|NCT01238471|OG001|Outcome|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
11037387|NCT01238471|EG000|Reported Event|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
11037388|NCT01238471|EG001|Reported Event|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
11037389|NCT01238536|BG000|Baseline|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
11037390|NCT01238536|BG001|Baseline|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
11037391|NCT01238536|BG002|Baseline|Total|Total of all reporting groups
11037392|NCT01238536|FG000|Participant Flow|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
11037393|NCT01238536|FG001|Participant Flow|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
11037394|NCT01238536|OG000|Outcome|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
11037395|NCT01238536|OG001|Outcome|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
11037396|NCT01238536|OG000|Outcome|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)"
11037397|NCT01238536|OG001|Outcome|Epidural Local Anesthetic Injection|Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
11037398|NCT01238536|EG000|Reported Event|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
11037399|NCT01238536|EG001|Reported Event|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
11037400|NCT01238549|BG000|Baseline|Spinal Cord Injury|Participants with SCI
11037401|NCT01238549|FG000|Participant Flow|Spinal Cord Injury|Participants with SCI
11037402|NCT01238549|OG000|Outcome|Spinal Cord Injury|Participants with SCI
11037403|NCT01238549|EG000|Reported Event|Spinal Cord Injury|Participants with SCI
11037404|NCT01238575|BG000|Baseline|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
11037405|NCT01238575|BG001|Baseline|Inactive Placebo|placebo: Administered for up to 8 weeks.
11037406|NCT01238575|BG002|Baseline|Total|Total of all reporting groups
11037407|NCT01238575|FG000|Participant Flow|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
11037408|NCT01238575|FG001|Participant Flow|Inactive Placebo|placebo: Administered for up to 8 weeks.
11037409|NCT01238575|OG000|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
11037410|NCT01238575|OG001|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
11037411|NCT01238575|EG000|Reported Event|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
11037412|NCT01238575|EG001|Reported Event|Inactive Placebo|placebo: Administered for up to 8 weeks.
11037413|NCT01238588|BG000|Baseline|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
11037414|NCT01238588|FG000|Participant Flow|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
11037415|NCT01238588|OG000|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
11037416|NCT01238588|EG000|Reported Event|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
11037417|NCT01238640|BG000|Baseline|Overall Study|
11037418|NCT01238640|FG000|Participant Flow|Overall Study|
11037419|NCT01238640|OG000|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
11037420|NCT01238640|OG001|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
11037421|NCT01238640|OG002|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
11037422|NCT01238640|EG000|Reported Event|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
11037423|NCT01238640|EG001|Reported Event|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
11037424|NCT01238640|EG002|Reported Event|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
11037425|NCT01238822|BG000|Baseline|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
11037426|NCT01238822|FG000|Participant Flow|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
11037427|NCT01238822|OG000|Outcome|Placebo|placebo
11037428|NCT01238822|OG001|Outcome|Low Dosage|18 mg methylphenidate
11037429|NCT01238822|OG002|Outcome|Medium Dosage|36 mg methylphenidate if >25 kg; 27 mg methylphenidate if < 25 kg.
11037430|NCT01238822|OG003|Outcome|High Dosage|54 mg methylphenidate if >25 kg; 36 mg methylphenidate if < 25 kg.
11037431|NCT01238822|EG000|Reported Event|Placebo|
11037432|NCT01238822|EG001|Reported Event|Low Dosage|Low dose: 18 mg methylphenidate
11037433|NCT01238822|EG002|Reported Event|Medium Dosage|Medium Dosage: 36 mg methylphenidate
11037434|NCT01238822|EG003|Reported Event|High Dosage|54 mg methylphenidate
11037435|NCT01238835|BG000|Baseline|TAVR-TA|"Transcatheter valve replacement with transapical access~SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach"
11037436|NCT01238835|FG000|Participant Flow|TAVR-TA|"Transcatheter valve replacement with transapical access~SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach"
11037437|NCT01238835|OG000|Outcome|TAVR-TA|"Transcatheter valve replacement with transapical access~SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach"
11037438|NCT01238835|EG000|Reported Event|TAVR-TA|"Transcatheter valve replacement with transapical access~SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach"
11037439|NCT01238848|BG000|Baseline|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
11037440|NCT01238848|BG001|Baseline|Normal|Normal saline (sodium chloride 0.9%) + albuterol
11037441|NCT01238848|BG002|Baseline|Total|Total of all reporting groups
11037442|NCT01238848|FG000|Participant Flow|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
11037443|NCT01238848|FG001|Participant Flow|Normal|Normal saline (sodium chloride 0.9%) + albuterol
11037444|NCT01238848|OG000|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
11037445|NCT01238848|OG001|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
11037446|NCT01238848|EG000|Reported Event|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
11037447|NCT01238848|EG001|Reported Event|Normal|Normal saline (sodium chloride 0.9%) + albuterol
11037448|NCT01238861|BG000|Baseline|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037449|NCT01238861|BG001|Baseline|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037450|NCT01238861|BG002|Baseline|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037451|NCT01238861|BG003|Baseline|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037452|NCT01238861|BG004|Baseline|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037453|NCT01238861|BG005|Baseline|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037454|NCT01238861|BG006|Baseline|Total|Total of all reporting groups
11037455|NCT01238861|FG000|Participant Flow|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037456|NCT01238861|FG001|Participant Flow|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037457|NCT01238861|FG002|Participant Flow|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037458|NCT01238861|FG003|Participant Flow|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037459|NCT01238861|FG004|Participant Flow|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037460|NCT01238861|FG005|Participant Flow|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037461|NCT01238861|OG000|Outcome|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037462|NCT01238861|OG001|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037463|NCT01238861|OG002|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037464|NCT01238861|OG003|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037465|NCT01238861|OG000|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
11037466|NCT01238861|OG000|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037467|NCT01238861|OG001|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037468|NCT01238861|OG002|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
11037469|NCT01238861|OG004|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037470|NCT01238861|OG005|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
11037471|NCT01238861|OG000|Outcome|Placebo|EOS+ and EOS- participants received two placebo injections subcutaneously.
11037472|NCT01238861|OG003|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
11037473|NCT01238861|OG000|Outcome|Placebo|Participants received two placebo injections subcutaneously.
11037474|NCT01238861|EG000|Reported Event|EOS POS Placebo|EOS+ participants received two placebo injections subcutaneously.
11037475|NCT01238861|EG001|Reported Event|EOS POS Benralizumab 2 mg|EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
11037476|NCT01238861|EG002|Reported Event|EOS POS Benralizumab 20 mg|EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
11037477|NCT01238861|EG003|Reported Event|EOS POS Benralizumab 100 mg|EOS+ participants received two benralizumab 50 mg injections subcutaneously.
11037478|NCT01238861|EG004|Reported Event|EOS NEG Placebo|EOS- participants received two placebo injections subcutaneously.
11037479|NCT01238861|EG005|Reported Event|EOS NEG Benralizumab 100 mg|EOS- participants received two benralizumab 50 mg injections subcutaneously.
11037480|NCT01238900|BG000|Baseline|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
11037481|NCT01238900|FG000|Participant Flow|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
11037482|NCT01238900|OG000|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
11037483|NCT01238900|OG000|Outcome|Per- Protocol Analysis of Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
11037484|NCT01238900|EG000|Reported Event|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
11037485|NCT01238991|BG000|Baseline|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037486|NCT01238991|BG001|Baseline|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037487|NCT01238991|BG002|Baseline|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037488|NCT01238991|BG003|Baseline|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037489|NCT01238991|BG004|Baseline|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037490|NCT01238991|BG005|Baseline|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037491|NCT01238991|BG006|Baseline|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037492|NCT01238991|BG007|Baseline|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037493|NCT01238991|BG008|Baseline|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037494|NCT01238991|BG009|Baseline|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037495|NCT01238991|BG010|Baseline|Total|Total of all reporting groups
11037496|NCT01238991|FG000|Participant Flow|3 μg ACC-001+QS-21|A group of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037497|NCT01238991|FG001|Participant Flow|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037498|NCT01238991|FG002|Participant Flow|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037499|NCT01238991|FG003|Participant Flow|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037500|NCT01238991|FG004|Participant Flow|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037501|NCT01238991|FG005|Participant Flow|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037502|NCT01238991|FG006|Participant Flow|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037503|NCT01238991|FG007|Participant Flow|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037504|NCT01238991|FG008|Participant Flow|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037505|NCT01238991|FG009|Participant Flow|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037506|NCT01238991|OG000|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037507|NCT01238991|OG001|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037508|NCT01238991|OG002|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037509|NCT01238991|OG003|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037510|NCT01238991|OG004|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037511|NCT01238991|OG005|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037512|NCT01238991|OG000|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037513|NCT01238991|OG001|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037514|NCT01238991|OG002|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037515|NCT01238991|OG003|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037516|NCT01238991|OG004|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037517|NCT01238991|OG005|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037518|NCT01238991|OG006|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11226822|NCT02378220|OG001|Outcome|"Intervention (Tested)"|"Patients in the tested group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.~Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System"
11037519|NCT01238991|OG007|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037520|NCT01238991|OG008|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037521|NCT01238991|OG009|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
11037522|NCT01238991|EG000|Reported Event|3μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
11037523|NCT01238991|EG001|Reported Event|3μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and acctive vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037524|NCT01238991|EG002|Reported Event|10ug ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037525|NCT01238991|EG003|Reported Event|10μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037526|NCT01238991|EG004|Reported Event|30μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037527|NCT01238991|EG005|Reported Event|30μg Control|A group of participants who received IM injection of adjuvant QS-21(50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
11037528|NCT01238991|EG006|Reported Event|Total|All participants
11037529|NCT01239043|BG000|Baseline|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
11037530|NCT01239043|BG001|Baseline|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
11037531|NCT01239043|BG002|Baseline|Total|Total of all reporting groups
11037532|NCT01239043|FG000|Participant Flow|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
11037533|NCT01239043|FG001|Participant Flow|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
11037534|NCT01239043|OG000|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
11037535|NCT01239043|OG001|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
11037536|NCT01239043|EG000|Reported Event|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
11037537|NCT01239043|EG001|Reported Event|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
11037538|NCT01239056|BG000|Baseline|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
11037539|NCT01239056|FG000|Participant Flow|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
11037540|NCT01239056|OG000|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
11037541|NCT01239056|OG000|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
11037542|NCT01239056|EG000|Reported Event|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
11037543|NCT01239121|BG000|Baseline|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
11037544|NCT01239121|BG001|Baseline|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
11037545|NCT01239121|BG002|Baseline|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
11037546|NCT01239121|BG003|Baseline|Total|Total of all reporting groups
11037547|NCT01239121|FG000|Participant Flow|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
11037548|NCT01239121|FG001|Participant Flow|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
11037549|NCT01239121|FG002|Participant Flow|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
11037550|NCT01239121|OG000|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
11037551|NCT01239121|OG001|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
11037552|NCT01239121|OG002|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
11037553|NCT01239121|EG000|Reported Event|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
11037554|NCT01239121|EG001|Reported Event|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
11037555|NCT01239121|EG002|Reported Event|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
11037556|NCT01239160|BG000|Baseline|Advanced PCD|"The use of an advanced PCD device to reduce and maintain limb volume~Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between normal and increased. The device is intended to be used for 60 minutes per day."
11037557|NCT01239160|BG001|Baseline|Simple PCD|"The use of the Simple PCD is to reduce and maintain limb volume~Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day."
11037558|NCT01239160|BG002|Baseline|Total|Total of all reporting groups
11037559|NCT01239160|FG000|Participant Flow|Advanced PCD|"The use of an advanced PCD device to reduce and maintain limb volume~Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between normal and increased. The device is intended to be used for 60 minutes per day"
11037560|NCT01239160|FG001|Participant Flow|Simple PCD|"The use of the Simple PCD is to reduce and maintain limb volume~Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day."
11037561|NCT01239160|FG002|Participant Flow|Treatment Not Assigned|Consented, but did withdrawn prior to being randomized into one of the treatment groups.
11037562|NCT01239160|OG000|Outcome|Advanced PCD|"The use of an advanced PCD device to reduce and maintain limb volume~Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between normal and increased. The device is intended to be used for 60 minutes per day"
11037563|NCT01239160|OG001|Outcome|Simple PCD|"The use of the Simple PCD is to reduce and maintain limb volume~Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day."
11037564|NCT01239160|EG000|Reported Event|Advanced PCD|"The use of an advanced PCD device to reduce and maintain limb volume~Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between normal and increased. The device is intended to be used for 60 minutes per day"
11037565|NCT01239160|EG001|Reported Event|Simple PCD|"The use of the Simple PCD is to reduce and maintain limb volume~Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day."
11037566|NCT01239212|BG000|Baseline|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
11037567|NCT01239212|FG000|Participant Flow|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
11037568|NCT01239212|OG000|Outcome|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
11037569|NCT01239212|EG000|Reported Event|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
11037570|NCT01239316|BG000|Baseline|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
11037571|NCT01239316|FG000|Participant Flow|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
11037572|NCT01239316|OG000|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
11037573|NCT01239316|EG000|Reported Event|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
11037574|NCT01239342|BG000|Baseline|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
11037575|NCT01239342|BG001|Baseline|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
11037576|NCT01239342|BG002|Baseline|Total|Total of all reporting groups
11226139|NCT02372006|BG001|Baseline|Dose Finding - Level 1|"Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11226140|NCT02372006|BG002|Baseline|Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11226141|NCT02372006|BG003|Baseline|Total|Total of all reporting groups
11226142|NCT02372006|FG000|Participant Flow|Dose Finding - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11226143|NCT02372006|FG001|Participant Flow|Dose Finding - Level 1|"Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11226144|NCT02372006|FG002|Participant Flow|Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11226823|NCT02378220|OG000|Outcome|"Intervention (Tested)"|"Patients in the tested group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.~Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System"
11226824|NCT02378220|EG000|Reported Event|"Controls (Not Tested)"|Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)
11037577|NCT01239342|FG000|Participant Flow|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
11037578|NCT01239342|FG001|Participant Flow|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
11037579|NCT01239342|OG000|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
11037580|NCT01239342|OG001|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
11037581|NCT01239342|EG000|Reported Event|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
11037582|NCT01239342|EG001|Reported Event|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
11037583|NCT01239355|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11037584|NCT01239355|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11037585|NCT01239355|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11037586|NCT01239355|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11037587|NCT01239381|BG000|Baseline|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
11037588|NCT01239381|FG000|Participant Flow|SBRT-Proton|"Stereotactic Body Radiation Therapy (SBRT) by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
11037589|NCT01239381|OG000|Outcome|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
11037590|NCT01239381|OG000|Outcome|SBRT-Proton|"Stereotactic Body Radiation Therapy (SBRT) by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
11037591|NCT01239381|EG000|Reported Event|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
11037592|NCT01239394|BG000|Baseline|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
11037593|NCT01239394|FG000|Participant Flow|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
11037594|NCT01239394|OG000|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
11037595|NCT01239394|EG000|Reported Event|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
11037596|NCT01239472|BG000|Baseline|Tacrolimus|Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone with low immunologic risk .
11037597|NCT01239472|BG001|Baseline|Everolimus|Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone with low immunologic risk, and converted for use of mycophenolate sodium, everolimus, and prednisone after 90 days of kidney transplantation.
11037598|NCT01239472|BG002|Baseline|Total|Total of all reporting groups
11037599|NCT01239472|FG000|Participant Flow|Tacrolimus|Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone the whole study
11037600|NCT01239472|FG001|Participant Flow|Everolimus|Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, whom switched tacrolimus to everolimus 90 days after renal transplantation. Since then the patients kept taking everolimus, mycophenolate sodium and prednisone
11037601|NCT01239472|OG000|Outcome|Tacrolimus|Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, during the whole study. This is the no intervention group.
11037602|NCT01239472|OG001|Outcome|Everolimus|Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone at beginning, but whom switched tacrolimus to everolimus at 90 days after transplant. This is the intervention group
11037603|NCT01239472|OG000|Outcome|Tacrolimus|Kidney transplant patients with living donors starting with the use of tacrolimus, mycophenolate sodium and prednisone without induction.
11037604|NCT01239472|OG001|Outcome|Everolimus|Kidney transplant patients with living donors starting with the use of tacrolimus, mycophenolate sodium and prednisone without induction, and converted for use of mycophenolate sodium, everolimus, and prednisone after 90 days of kidney transplantation.
11037605|NCT01239472|EG000|Reported Event|Tacrolimus|Kidney transplant patients starting taking tacrolimus, mycophenolate sodium and prednisone, and keeping it the whole study.
11037606|NCT01239472|EG001|Reported Event|Everolimus|Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, and whom switched tacrolimus to everolimus 90 days after renal transplantation. Therefore the patients were taking everolimus, mycophenolate sodium and prednisone since 90 days after the transplant, and kept this way during the whole study
11037607|NCT01239511|BG000|Baseline|Placebo Group|placebo capsule 2# t.i.d./day
11037608|NCT01239511|BG001|Baseline|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
11037609|NCT01239511|BG002|Baseline|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
11037610|NCT01239511|BG003|Baseline|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
11037611|NCT01239511|BG004|Baseline|Total|Total of all reporting groups
11037612|NCT01239511|FG000|Participant Flow|Placebo Group|placebo capsule 2# t.i.d./day
11037613|NCT01239511|FG001|Participant Flow|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
11037614|NCT01239511|FG002|Participant Flow|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
11037615|NCT01239511|FG003|Participant Flow|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
11037616|NCT01239511|OG000|Outcome|Placebo Group|placebo capsule 2# t.i.d./day
11037617|NCT01239511|OG001|Outcome|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
11037618|NCT01239511|OG002|Outcome|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
11037619|NCT01239511|OG003|Outcome|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
11037620|NCT01239511|EG000|Reported Event|Placebo Group|placebo capsule 2# t.i.d./day
11037621|NCT01239511|EG001|Reported Event|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
11037622|NCT01239511|EG002|Reported Event|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
11037623|NCT01239511|EG003|Reported Event|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
11037624|NCT01239732|BG000|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
11037625|NCT01239732|FG000|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 milligram per square meter (mg/m^2) IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (area under the plasma concentration-time curve [AUC] 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
11037626|NCT01239732|OG000|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
11037627|NCT01239732|EG000|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
11037628|NCT01239745|BG000|Baseline|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
11037629|NCT01239745|FG000|Participant Flow|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
11037630|NCT01239745|OG000|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
11037631|NCT01239745|EG000|Reported Event|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
11037632|NCT01239992|BG000|Baseline|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
11037633|NCT01239992|FG000|Participant Flow|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
11037634|NCT01239992|OG000|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
11037635|NCT01239992|EG000|Reported Event|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
11037636|NCT01240122|BG000|Baseline|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
11037637|NCT01240122|FG000|Participant Flow|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
11037638|NCT01240122|OG000|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
11037639|NCT01240122|OG001|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
11037640|NCT01240122|OG000|Outcome|Biotrue MPS|Paired/parallel eye evaluation; each subject was treated with Biotrue multi-purpose solution in one eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
11037641|NCT01240122|OG001|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used Investigational MPS in the alternate eye and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
11037642|NCT01240122|OG000|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue MPS in one eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
11037643|NCT01240122|OG001|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used the Investigational MPS in the alternate eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
11037644|NCT01240122|EG000|Reported Event|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
11037645|NCT01240135|BG000|Baseline|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
11037646|NCT01240135|BG001|Baseline|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
11037647|NCT01240135|BG002|Baseline|Total|Total of all reporting groups
11037648|NCT01240135|FG000|Participant Flow|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
11037649|NCT01240135|FG001|Participant Flow|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
11037650|NCT01240135|OG000|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
11037651|NCT01240135|OG001|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
11037652|NCT01240135|EG000|Reported Event|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
11037653|NCT01240135|EG001|Reported Event|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
11037654|NCT01240200|BG000|Baseline|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
11037655|NCT01240200|BG001|Baseline|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
11037656|NCT01240200|BG002|Baseline|Total|Total of all reporting groups
11037657|NCT01240200|FG000|Participant Flow|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
11037658|NCT01240200|FG001|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
11037659|NCT01240200|OG000|Outcome|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
11037660|NCT01240200|OG001|Outcome|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
11037661|NCT01240200|OG001|Outcome|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover study group of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
11037662|NCT01240200|OG000|Outcome|Vial & Syringe|Participants from both dosing sequences (Period 1 and Period 2) using a vial and syringe during the study to self-administer insulin glargine.
11037663|NCT01240200|OG001|Outcome|SoloSTAR Pen|Participants from both dosing sequences (Period 1 and Period 2) using the SoloSTAR Pen during the study to self-administer insulin glargine.
11037664|NCT01240200|EG000|Reported Event|Vial and Syringe|Participants, from both dosing sequences (Period 1 and Period 2), using a vial and syringe during the study to self-administer insulin.
11037665|NCT01240200|EG001|Reported Event|SoloSTAR Pen|Participants, from both dosing sequences (Period 1 and Period 2), using the SoloSTAR Pen during the study to self-administer insulin.
11037666|NCT01240330|BG000|Baseline|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
11037667|NCT01240330|FG000|Participant Flow|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
11037668|NCT01240330|OG000|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
11037669|NCT01240330|EG000|Reported Event|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
11037670|NCT01240356|BG000|Baseline|Phase I|Non-stroke volunteers.
11037671|NCT01240356|BG001|Baseline|Phase II|Phase II-20 patients with ischemic stroke treated with IV-tPA
11037672|NCT01240356|BG002|Baseline|Total|Total of all reporting groups
11037673|NCT01240356|FG000|Participant Flow|Phase I|Non-stroke volunteers.
11037674|NCT01240356|FG001|Participant Flow|Phase II|Acute Ischemic Stroke patients received standard-doce intravenous tissue-type plasminogen activator (tPA) within 0-3 hours window.
11037675|NCT01240356|OG000|Outcome|Phase I|Non stroke patients
11037676|NCT01240356|OG000|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
11037677|NCT01240356|OG000|Outcome|Phase 1 (Healthy Volunteers)|Phase I - A group of non-stroke healthy volunteers.
11037678|NCT01240356|OG000|Outcome|Phase II - Iscehmic Stroke Patients|Phase II - 20 patients with ischemic stroke treated with IV-tPA
11037679|NCT01240356|OG000|Outcome|Phase I: Healthy Volunteers|Phase I - A group of 15 Non-stroke healthy volunteers.
11037680|NCT01240356|EG000|Reported Event|Phase I: Healthy Volunteers|Phase I - 15 non-stroke healthy volunteers.
11037681|NCT01240356|EG001|Reported Event|Phase II - Ischemic Stroke Patients|Phase II - 20 patient with ischemic stroke treated with IV-tPA
11037682|NCT01240382|BG000|Baseline|3% DE-089|3% DE-089 ophthalmic solution
11037683|NCT01240382|BG001|Baseline|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
11037684|NCT01240382|BG002|Baseline|Total|Total of all reporting groups
11037685|NCT01240382|FG000|Participant Flow|3% DE-089|3% DE-089 ophthalmic solution
11037686|NCT01240382|FG001|Participant Flow|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
11037687|NCT01240382|OG000|Outcome|3% DE-089|3% DE-089 ophthalmic solution
11037688|NCT01240382|OG001|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
11037689|NCT01240382|EG000|Reported Event|3% DE-089|3% DE-089 ophthalmic solution
11037690|NCT01240382|EG001|Reported Event|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
11037691|NCT01240551|BG000|Baseline|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
11037692|NCT01240551|BG001|Baseline|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
11037693|NCT01240551|BG002|Baseline|Total|Total of all reporting groups
11037694|NCT01240551|FG000|Participant Flow|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
11037695|NCT01240551|FG001|Participant Flow|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
11037696|NCT01240551|OG000|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
11037697|NCT01240551|OG001|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
11037698|NCT01240551|EG000|Reported Event|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
11037699|NCT01240551|EG001|Reported Event|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
11037700|NCT01240590|BG000|Baseline|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
11037701|NCT01240590|BG001|Baseline|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
11037702|NCT01240590|BG002|Baseline|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
11037703|NCT01240590|BG003|Baseline|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
11037704|NCT01240590|BG004|Baseline|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
11037705|NCT01240590|BG005|Baseline|Total|Total of all reporting groups
11037706|NCT01240590|FG000|Participant Flow|Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
11037707|NCT01240590|FG001|Participant Flow|Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
11037708|NCT01240590|FG002|Participant Flow|Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
11037709|NCT01240590|FG003|Participant Flow|Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
11037710|NCT01240590|FG004|Participant Flow|Level 4: Cisplatin|100mg/m(2) Cisplatin Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
11037711|NCT01240590|OG000|Outcome|All Participants|All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
11037712|NCT01240590|OG000|Outcome|All Participants|All participants who received at least one dose of 8-20 mg/m(2)crolibulin intravenously.
11037713|NCT01240590|OG000|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
11037714|NCT01240590|OG001|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
11037715|NCT01240590|OG000|Outcome|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
11037716|NCT01240590|OG001|Outcome|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
11037717|NCT01240590|OG002|Outcome|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
11037718|NCT01240590|OG003|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
11037719|NCT01240590|OG004|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
11037720|NCT01240590|OG000|Outcome|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
11037721|NCT01240590|OG001|Outcome|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
11037722|NCT01240590|OG002|Outcome|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
11037723|NCT01240590|OG003|Outcome|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
11037724|NCT01240590|OG004|Outcome|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
11037725|NCT01240590|OG000|Outcome|Ph I Level -1: Cisplatin + Crolibulin|"75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
11037726|NCT01240590|OG001|Outcome|Ph I Level 1: Cisplatin + Crolibulin|"75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
11037727|NCT01240590|OG002|Outcome|Ph I Level 2: Cisplatin + Crolibulin|"100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
11037728|NCT01240590|OG003|Outcome|Ph II Level 3: Cisplatin + Crolibulin|"100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
11037729|NCT01240590|OG004|Outcome|Ph II Level 4: Cisplatin|"100mg/m(2) Cisplatin~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
11037730|NCT01240590|EG000|Reported Event|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
11037731|NCT01240590|EG001|Reported Event|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
11037732|NCT01240590|EG002|Reported Event|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
11037733|NCT01240590|EG003|Reported Event|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
11037734|NCT01240590|EG004|Reported Event|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
11037735|NCT01240746|BG000|Baseline|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
11037736|NCT01240746|BG001|Baseline|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
11037737|NCT01240746|BG002|Baseline|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
11037738|NCT01240746|BG003|Baseline|Total|Total of all reporting groups
11037739|NCT01240746|FG000|Participant Flow|Study Group 1 (2010-2011 Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen.
11037740|NCT01240746|FG001|Participant Flow|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
11037741|NCT01240746|FG002|Participant Flow|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
11037742|NCT01240746|OG000|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
11037743|NCT01240746|OG001|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
11037744|NCT01240746|OG002|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
11037745|NCT01240746|EG000|Reported Event|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
11037746|NCT01240746|EG001|Reported Event|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
11037747|NCT01240746|EG002|Reported Event|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
11037748|NCT01240785|BG000|Baseline|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
11037749|NCT01240785|BG001|Baseline|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
11037750|NCT01240785|BG002|Baseline|Total|Total of all reporting groups
11037751|NCT01240785|FG000|Participant Flow|Metformin Arm|
11037752|NCT01240785|FG001|Participant Flow|Insulin|
11037753|NCT01240785|OG000|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
11037754|NCT01240785|OG001|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
11037755|NCT01240785|EG000|Reported Event|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
11037756|NCT01240785|EG001|Reported Event|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
11037757|NCT01240811|BG000|Baseline|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
11037758|NCT01240811|BG001|Baseline|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
11037759|NCT01240811|BG002|Baseline|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
11037760|NCT01240811|BG003|Baseline|Total|Total of all reporting groups
11037761|NCT01240811|FG000|Participant Flow|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
11037762|NCT01240811|FG001|Participant Flow|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
11037763|NCT01240811|FG002|Participant Flow|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
11037764|NCT01240811|OG000|Outcome|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
11037765|NCT01240811|OG001|Outcome|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
11037766|NCT01240811|OG002|Outcome|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
11037767|NCT01240811|OG001|Outcome|Levonorgestrel IUS|"Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.~IUD placement: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).~Levonorgestrel IUD"
11037768|NCT01240811|OG002|Outcome|Copper T380A IUD|"Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.~IUD placement: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).~Copper T380A IUD"
11037769|NCT01240811|EG000|Reported Event|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
11037770|NCT01240811|EG001|Reported Event|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
11037771|NCT01240811|EG002|Reported Event|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
11037772|NCT01240863|BG000|Baseline|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11037773|NCT01240863|BG001|Baseline|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11037774|NCT01240863|BG002|Baseline|Total|Total of all reporting groups
11037775|NCT01240863|FG000|Participant Flow|Hydrocodone ER (Open-Label Titration Period)|All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
11037776|NCT01240863|FG001|Participant Flow|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11037777|NCT01240863|FG002|Participant Flow|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11037778|NCT01240863|OG000|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11037779|NCT01240863|OG001|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11037780|NCT01240863|OG001|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered ER hydrocodone tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11037781|NCT01240863|OG000|Outcome|Open-Label Titration: Opioid Naive|During the open label titration period, all participants received hydrocodone extended release tablets on an open-label basis. Opioid naïve participants (ie, those taking less than 10 mg/day of oxycodone or equivalent, during the 14 days before screening) started at a 15 mg dose of hydrocodone extended release, administered every 12 hours. A decision regarding dose adjustment was made based on whether the criterion of successful dose (ie, dose that produced stable pain relief) was met. In general, dose escalation stepped from 15 mg to 30 mg, 45 mg, 60 mg, and 90 mg every 12 hours until stable pain relief was obtained.
11037782|NCT01240863|OG001|Outcome|Open-Label Titration: Opioid Experienced|"During the open label titration period, all participants received hydrocodone extended release tablets on an open-label basis. Opioid experienced participants switched from their current opioid medications to the calculated dose of hydrocodone extended release tablets based on an equianalgesic dose-conversion scheme.~A decision regarding dose adjustment was made based on whether the criterion of successful dose (ie, dose that produced stable pain relief) was met. In general, dose escalation stepped to 30 mg or 45 mg or 60 mg, or 90 mg every 12 hours until stable pain relief was obtained. The escalated dose was dependent upon the initial calculated equivalent dose."
11037783|NCT01240863|OG002|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11037784|NCT01240863|OG003|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11037785|NCT01240863|EG000|Reported Event|Hydrocodone ER (Open-Label Titration Period)|All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
11037786|NCT01240863|EG001|Reported Event|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
11037787|NCT01240863|EG002|Reported Event|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
11037788|NCT01240915|BG000|Baseline|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
11037789|NCT01240915|BG001|Baseline|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037790|NCT01240915|BG002|Baseline|Cohort 1: MultiStem 300 or MultiStem 300 (x3), Placebo|Participants received either a single dose of MultiStem 300 Million Cells infusion on Day 1 or 3 doses on Day 1, Week 1, and Week 2; followed by a single dose of placebo infusion at Week 8.
11037791|NCT01240915|BG003|Baseline|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037792|NCT01240915|BG004|Baseline|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037793|NCT01240915|BG005|Baseline|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037794|NCT01240915|BG006|Baseline|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037795|NCT01240915|BG007|Baseline|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037796|NCT01240915|BG008|Baseline|Total|Total of all reporting groups
11037797|NCT01240915|FG000|Participant Flow|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
11037798|NCT01240915|FG001|Participant Flow|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037799|NCT01240915|FG002|Participant Flow|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037800|NCT01240915|FG003|Participant Flow|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
11037801|NCT01240915|FG004|Participant Flow|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037802|NCT01240915|FG005|Participant Flow|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037803|NCT01240915|FG006|Participant Flow|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037804|NCT01240915|FG007|Participant Flow|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037805|NCT01240915|FG008|Participant Flow|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037806|NCT01240915|OG000|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
11037807|NCT01240915|OG001|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
11037808|NCT01240915|OG000|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
11037809|NCT01240915|OG001|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037810|NCT01240915|OG002|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037811|NCT01240915|OG003|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
11037812|NCT01240915|OG004|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037813|NCT01240915|OG005|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037814|NCT01240915|OG006|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037815|NCT01240915|OG007|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037816|NCT01240915|OG008|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037817|NCT01240915|EG000|Reported Event|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
11037818|NCT01240915|EG001|Reported Event|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037819|NCT01240915|EG002|Reported Event|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037820|NCT01240915|EG003|Reported Event|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
11037821|NCT01240915|EG004|Reported Event|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037822|NCT01240915|EG005|Reported Event|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037823|NCT01240915|EG006|Reported Event|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037824|NCT01240915|EG007|Reported Event|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
11037825|NCT01240915|EG008|Reported Event|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
11037826|NCT01241240|BG000|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
11037827|NCT01241240|BG001|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
11037828|NCT01241240|BG002|Baseline|Total|Total of all reporting groups
11037829|NCT01241240|FG000|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
11037830|NCT01241240|FG001|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
11037831|NCT01241240|OG000|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
11037832|NCT01241240|OG001|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
11037833|NCT01241240|EG000|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
11037834|NCT01241240|EG001|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
11037835|NCT01241292|BG000|Baseline|Elotuzumab 10 mg/kg|Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
11037836|NCT01241292|BG001|Baseline|Elotuzumab 20 mg/kg|Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
11037837|NCT01241292|BG002|Baseline|Total|Total of all reporting groups
11037838|NCT01241292|FG000|Participant Flow|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
11037839|NCT01241292|FG001|Participant Flow|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
11037840|NCT01241292|OG000|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
11037841|NCT01241292|OG001|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
11037842|NCT01241292|OG000|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
11066501|NCT01392573|EG001|Reported Event|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11037843|NCT01241292|OG001|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
11037844|NCT01241292|OG000|Outcome|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
11037845|NCT01241292|OG001|Outcome|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
11037846|NCT01241292|EG000|Reported Event|BMS 10mg/kg + Ld|
11037847|NCT01241292|EG001|Reported Event|BMS 20mg/kg + Ld|
11037848|NCT01241318|BG000|Baseline|Chlorhexidine Cord Care|"Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.~Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."
11037849|NCT01241318|BG001|Baseline|Dry Cord Care|"Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.~Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."
11037850|NCT01241318|BG002|Baseline|Total|Total of all reporting groups
11037851|NCT01241318|FG000|Participant Flow|Chlorhexidine Cord Care|"Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.~Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."
11037852|NCT01241318|FG001|Participant Flow|Dry Cord Care|"Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.~Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."
11037853|NCT01241318|OG000|Outcome|Chlorhexidine Cord Care|"Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.~Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."
11037854|NCT01241318|OG001|Outcome|Dry Cord Care|"Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.~Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."
11037855|NCT01241318|OG000|Outcome|Facility Delivery|Women who enrolled in ZamCAT study and delivered at a facility
11037856|NCT01241318|OG001|Outcome|Home Delivery|Women who enrolled in ZamCAT study and delivered at home
11037857|NCT01241318|OG000|Outcome|Study Health Facilities & Hospitals|90 health facilities and 10 district hospitals were included in the main chlorhexidine trial. A survey was completed to assess availability of emergency obstetric care.
11037858|NCT01241318|EG000|Reported Event|Chlorhexidine Cord Care|"Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.~Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body."
11037859|NCT01241318|EG001|Reported Event|Dry Cord Care|"Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.~Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump."
11037860|NCT01241344|BG000|Baseline|BCV BIW|"Randomized (Blinded) Phase~Adult subjects: 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).~Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg)."
11037861|NCT01241344|BG001|Baseline|BCV QW|"Randomized (Blinded) Phase~Adult subjects: 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally once weekly (QW).~Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg)."
11037862|NCT01241344|BG002|Baseline|Placebo|"Randomized (Blinded) Phase~Adult subjects: Matching placebo tablets taken orally once weekly (QW) or twice weekly (BIW).~Pediatric subjects: Matching liquid placebo taken orally QW or BIW."
11037863|NCT01241344|BG003|Baseline|BCV Direct to Open-Label|"Subjects who were enrolled directly to open-label and had not been previously randomized (n=4) received 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).~This number does not include subjects who were previously randomized and moved to open-label (n=8), as they are represented in their previously randomized arm."
11037864|NCT01241344|BG004|Baseline|Total|Total of all reporting groups
11037865|NCT01241344|FG000|Participant Flow|Brincidofovir BIW|"Randomized (Blinded) Phase~Adult subjects: 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).~Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg)."
11037866|NCT01241344|FG001|Participant Flow|Brincidofovir QW|"Randomized (Blinded) Phase~Adult subjects: 200 mg brincidofovir (BCV) administered as two 50 mg tablets taken orally once weekly (QW).~Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg)"
11037867|NCT01241344|FG002|Participant Flow|Placebo|"Randomized (Blinded) Phase~Adult subjects: Matching placebo tablets taken orally once weekly (QW; 2 tablets) or twice weekly (BIW; 4 tablets).~Pediatric subjects: Matching liquid placebo taken orally QW or BIW."
11037868|NCT01241344|FG003|Participant Flow|Directly to Open-label|"Subjects who were enrolled directly to open-label and had not been previously randomized (n=4) received 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).~This number does not include subjects who were previously randomized and moved to open-label (n=8), as they are represented in their previously randomized arm."
11037869|NCT01241344|OG000|Outcome|BCV BIW|"Randomized (Blinded) Phase~Adult subjects: 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).~Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg)."
11037870|NCT01241344|OG001|Outcome|BCV QW|"Randomized (Blinded) Phase~Adult subjects: 200 mg brincidofovir (BCV) administered as two 50mg tablets taken orally once weekly (QW).~Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg)."
11037871|NCT01241344|OG002|Outcome|Placebo|"Randomized (Blinded) Phase~Adult subjects: Matching placebo tablets taken orally either once weekly (QW) or twice weekly (BIW).~Pediatric subjects: Matching liquid placebo taken orally either QW or BIW."
11037872|NCT01241344|EG000|Reported Event|BCV BIW|"Randomized (Blinded) Phase~Adult subjects: 200 mg brincidofocir (BCV) administered as four 50mg tablets orally twice weekly (BIW).~Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg)."
11037873|NCT01241344|EG001|Reported Event|BCV QW|"Randomized (Blinded) Phase~Adult subjects: 200 mg brincidofovir (BCV) administered as two 50mg tablets orally once weekly (QW).~Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg)."
11037874|NCT01241344|EG002|Reported Event|Placebo|"Randomized (Blinded) Phase~Adult subjects: Matching placebo tablets taken orally either once weekly (QW) or twice weekly (BIW).~Pediatric subjects: Matching liquid placebo taken orally QW or BIW."
11037875|NCT01241344|EG003|Reported Event|BCV Open-Label|Subjects who were enrolled directly to open-label and not randomized (n=4) and subjects who were previously randomized and moved to open-label (n=8) received 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).
11037876|NCT01241435|BG000|Baseline|Normal Hepatic Function|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
11037877|NCT01241435|BG001|Baseline|Mild Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
11037878|NCT01241435|BG002|Baseline|Moderate Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
11037879|NCT01241435|BG003|Baseline|Severe Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
11037880|NCT01241435|BG004|Baseline|Total|Total of all reporting groups
11037881|NCT01241435|FG000|Participant Flow|Normal Hepatic Function|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
11037882|NCT01241435|FG001|Participant Flow|Mild Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
11037883|NCT01241435|FG002|Participant Flow|Moderate Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
11037884|NCT01241435|FG003|Participant Flow|Severe Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
11037885|NCT01241435|OG000|Outcome|Normal Hepatic Function|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
11037886|NCT01241435|OG001|Outcome|Mild Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
11037887|NCT01241435|OG002|Outcome|Moderate Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
11037888|NCT01241435|OG003|Outcome|Severe Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
11037889|NCT01241435|EG000|Reported Event|Normal Hepatic Function|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
11037890|NCT01241435|EG001|Reported Event|Mild Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
11037891|NCT01241435|EG002|Reported Event|Moderate Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
11037892|NCT01241435|EG003|Reported Event|Severe Hepatic Impairment|LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
11037893|NCT01241448|BG000|Baseline|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037894|NCT01241448|BG001|Baseline|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037895|NCT01241448|BG002|Baseline|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037896|NCT01241448|BG003|Baseline|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037897|NCT01241448|BG004|Baseline|Total|Total of all reporting groups
11037898|NCT01241448|FG000|Participant Flow|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037899|NCT01241448|FG001|Participant Flow|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037900|NCT01241448|FG002|Participant Flow|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037901|NCT01241448|FG003|Participant Flow|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037902|NCT01241448|OG000|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037903|NCT01241448|OG001|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037904|NCT01241448|OG002|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037905|NCT01241448|OG003|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037906|NCT01241448|OG000|Outcome|LY2409021|2.5 mg, 10 mg or 20 mg LY2409021 taken orally once daily for 24 weeks
11037907|NCT01241448|EG000|Reported Event|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037908|NCT01241448|EG001|Reported Event|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037909|NCT01241448|EG002|Reported Event|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037910|NCT01241448|EG003|Reported Event|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
11037911|NCT01241461|BG000|Baseline|50 mg LY2584702|50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
11037912|NCT01241461|BG001|Baseline|75 mg LY2584702|75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
11037913|NCT01241461|BG002|Baseline|Total|Total of all reporting groups
11037914|NCT01241461|FG000|Participant Flow|50 mg LY2584702|50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
11037915|NCT01241461|FG001|Participant Flow|75 mg LY2584702|75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
11037916|NCT01241461|OG000|Outcome|50 mg LY2584702|50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
11037917|NCT01241461|OG001|Outcome|75 mg LY2584702|75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
11037918|NCT01241461|OG000|Outcome|50 mg LY2584702 Single Dose|50 milligram (mg) LY2584702 single oral dose on Day 1
11037919|NCT01241461|OG001|Outcome|75 mg LY2584702 Single Dose|75 mg LY2584702 single oral dose on Day 1
11037920|NCT01241461|OG002|Outcome|50 mg LY2584702 Multiple Doses|50 mg LY2584702 oral doses twice daily for a 28-day cycle
11037921|NCT01241461|OG003|Outcome|75 mg LY2584702 Multiple Doses|75 mg LY2584702 oral doses twice daily for a 28-day cycle
11037922|NCT01241461|EG000|Reported Event|50 mg LY2584702|50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
11037923|NCT01241461|EG001|Reported Event|75 mg LY2584702|75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
11037924|NCT01241513|BG000|Baseline|N-acetylcysteine (NAC)|NAC
11037925|NCT01241513|BG001|Baseline|Placebo|Placebo
11037926|NCT01241513|BG002|Baseline|Total|Total of all reporting groups
11037927|NCT01241513|FG000|Participant Flow|N-acetylcysteine|Active drug group
11037928|NCT01241513|FG001|Participant Flow|Placebo|Placebo
10849046|NCT00293397|FG000|Participant Flow|Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE)|"Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.~doxorubicin hydrochloride: Doxorubicin eluting beads"
11037929|NCT01241513|OG000|Outcome|Placebo Group|Placebo (Diet soda only)
11037930|NCT01241513|OG001|Outcome|NAC Group|N-acetyl-L-Cysteine (800 mg T.I.D. in diet soda) for 4 days
11037931|NCT01241513|EG000|Reported Event|NAC Group and Placebo Group|
11037932|NCT01241539|BG000|Baseline|Dabigatran|Dabigatran treated patients
11037933|NCT01241539|FG000|Participant Flow|Dabigatran|Period 1 target blood flow rate during dialysis was 200mL/min. Period 2 target blood flow rate during dialysis was 400mL/min.
11037934|NCT01241539|OG000|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
11037935|NCT01241539|OG001|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
11037936|NCT01241539|OG000|Outcome|Dabigatran|Dabigatran treated patients
11037937|NCT01241539|EG000|Reported Event|Dabigatran|Dabigatran treated patients
11037938|NCT01241552|BG000|Baseline|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
11037939|NCT01241552|BG001|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
11037940|NCT01241552|BG002|Baseline|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
11037941|NCT01241552|BG003|Baseline|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
11037942|NCT01241552|BG004|Baseline|Total|Total of all reporting groups
11037943|NCT01241552|FG000|Participant Flow|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care (SOC) for CDI
11037944|NCT01241552|FG001|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
11037945|NCT01241552|FG002|Participant Flow|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
11037946|NCT01241552|FG003|Participant Flow|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
11037947|NCT01241552|OG000|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
11037948|NCT01241552|OG001|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
11037949|NCT01241552|OG002|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
11037950|NCT01241552|OG003|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
11037951|NCT01241552|EG000|Reported Event|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + SOC for CDI
11037952|NCT01241552|EG001|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
11037953|NCT01241552|EG002|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
11037954|NCT01241552|EG003|Reported Event|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + SOC for CDI
11037955|NCT01241565|BG000|Baseline|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
11037956|NCT01241565|FG000|Participant Flow|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
11037957|NCT01241565|OG000|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
11037958|NCT01241565|OG000|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
11037959|NCT01241565|EG000|Reported Event|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
11037960|NCT01241591|BG000|Baseline|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037961|NCT01241591|BG001|Baseline|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037962|NCT01241591|BG002|Baseline|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037963|NCT01241591|BG003|Baseline|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037964|NCT01241591|BG004|Baseline|Total|Total of all reporting groups
11037965|NCT01241591|FG000|Participant Flow|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037966|NCT01241591|FG001|Participant Flow|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037967|NCT01241591|FG002|Participant Flow|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037968|NCT01241591|FG003|Participant Flow|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037969|NCT01241591|OG000|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037970|NCT01241591|OG001|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037971|NCT01241591|OG002|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037972|NCT01241591|OG003|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037973|NCT01241591|EG000|Reported Event|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037974|NCT01241591|EG001|Reported Event|CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037975|NCT01241591|EG002|Reported Event|Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037976|NCT01241591|EG003|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
11037977|NCT01241604|BG000|Baseline|All Participants|All participants that were consented.
11037978|NCT01241604|FG000|Participant Flow|Screening Population|All participants that signed consent are considered for the screening population.
11037979|NCT01241604|FG001|Participant Flow|Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3|Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device
11037980|NCT01241604|FG002|Participant Flow|Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T|Auto Servo Ventilation Device and then Mechanical Non-invasive Ventilation
11037981|NCT01241604|OG000|Outcome|Respironics BiPAP S/T|"Control Arm using Respironics BiPAP S/T~BiPAP S/T: Mechanical Non-invasive Ventilation"
11037982|NCT01241604|OG001|Outcome|Respironics BiPAP Auto SV3|"Treatment arm using Respironics BiPAP Auto SV3~BiPAP Auto SV3: Auto Servo Ventilation Device"
11037983|NCT01241604|EG000|Reported Event|Screening Period|All participants that were consented into the study.
11037984|NCT01241604|EG001|Reported Event|Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3|Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device
11037985|NCT01241604|EG002|Reported Event|Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T|Auto Servo Ventilation Device first and then Mechanical Non-invasive Ventilation
11037986|NCT01241760|BG000|Baseline|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
11037987|NCT01241760|BG001|Baseline|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
11037988|NCT01241760|BG002|Baseline|Total|Total of all reporting groups
11037989|NCT01241760|FG000|Participant Flow|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
11037990|NCT01241760|FG001|Participant Flow|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
11037991|NCT01241760|OG000|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
11037992|NCT01241760|OG001|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
11037993|NCT01241760|EG000|Reported Event|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
11037994|NCT01241760|EG001|Reported Event|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
11037995|NCT01241760|EG002|Reported Event|Total|All
11037996|NCT01241903|BG000|Baseline|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
11037997|NCT01241903|BG001|Baseline|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
11037998|NCT01241903|BG002|Baseline|Total|Total of all reporting groups
11037999|NCT01241903|FG000|Participant Flow|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
11038000|NCT01241903|FG001|Participant Flow|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
11038001|NCT01241903|OG000|Outcome|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
11038002|NCT01241903|OG001|Outcome|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
11038003|NCT01241903|EG000|Reported Event|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
11038004|NCT01241903|EG001|Reported Event|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
11226145|NCT02372006|OG000|Outcome|Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11038005|NCT01241916|BG000|Baseline|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
11038006|NCT01241916|BG001|Baseline|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
11038007|NCT01241916|BG002|Baseline|Total|Total of all reporting groups
11038008|NCT01241916|FG000|Participant Flow|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
11038009|NCT01241916|FG001|Participant Flow|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
11038010|NCT01241916|OG000|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
11038011|NCT01241916|OG001|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
11038012|NCT01241916|EG000|Reported Event|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
11038013|NCT01241916|EG001|Reported Event|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
11038014|NCT01242085|BG000|Baseline|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
11038015|NCT01242085|BG001|Baseline|Trumatch Group|patients randomized to study instrumentation
11038016|NCT01242085|BG002|Baseline|Both Interventions|one participant had bilateral knee replacement with one control knee and one trumatch knee
11038017|NCT01242085|BG003|Baseline|Total|Total of all reporting groups
11038018|NCT01242085|FG000|Participant Flow|Trumatch Group|trumatch group will have customized knee instruments : CT based customized knee instruments
11038019|NCT01242085|FG001|Participant Flow|Control Group|control group will have standard instrumentation of their knee replacement
11038020|NCT01242085|FG002|Participant Flow|Both Interventions|one participant had both interventions - one for each knee
11038021|NCT01242085|OG000|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
11038022|NCT01242085|OG001|Outcome|Trumatch Group|patients randomized to study instrumentation
11038023|NCT01242085|EG000|Reported Event|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
11038024|NCT01242085|EG001|Reported Event|Trumatch Group|patients randomized to study instrumentation
11038025|NCT01242111|BG000|Baseline|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
11038026|NCT01242111|FG000|Participant Flow|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
11038027|NCT01242111|OG000|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
11038028|NCT01242111|EG000|Reported Event|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
11038029|NCT01242176|BG000|Baseline|Study Overall|"An open-label, randomised, two-way crossover study. The two treatments administered were~A single dose of empagliflozin (empa) 25mg, final formulation~A single dose of empa 25mg, trial formulation 2~Between drug administrations there was a washout period of at least 7 days."
11038030|NCT01242176|FG000|Participant Flow|Empa FF / Empa TF2|Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments.
11038031|NCT01242176|FG001|Participant Flow|Empa TF2 / Empa FF|Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.
11038032|NCT01242176|OG000|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
11038033|NCT01242176|OG001|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
11038034|NCT01242176|EG000|Reported Event|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
11038035|NCT01242176|EG001|Reported Event|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
11038036|NCT01242241|BG000|Baseline|Obese Children|"Obese children are categorized as those with a body mass index >95th percentile~Propofol : Each Obese child/subject in this group received a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)"
11038037|NCT01242241|BG001|Baseline|Non-obese|"Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile~Propofol : This arm of patients(non-obese)served as the control group for the obese children. Each non-obese child/subject received a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)"
11038038|NCT01242241|BG002|Baseline|Total|Total of all reporting groups
11038039|NCT01242241|FG000|Participant Flow|Obese Children|"Obese children are categorized as those with a body mass index >95th percentile~Propofol : Each Obese child/subject in this group received a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)"
11038040|NCT01242241|FG001|Participant Flow|Non-obese|"Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile~Propofol : This arm of patients(non-obese)served as the control group for the obese children. Each non-obese child/subject received a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)"
11038041|NCT01242241|OG000|Outcome|Obese Children|"Obese children are categorized as those with a body mass index >95th percentile~Propofol : Each Obese child/subject in this group received a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)"
11038042|NCT01242241|OG001|Outcome|Non-obese|"Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile~Propofol : This arm of patients(non-obese)served as the control group for the obese children. Each non-obese child/subject received a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)"
11038043|NCT01242241|EG000|Reported Event|Non-obese|"Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile~Propofol: This arm of patients(non-obese)will act as the control group for the obese children. Each non-obese child/subject will receive a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)"
11038044|NCT01242241|EG001|Reported Event|Obese Children|"Obese children are categorized as those with a body mass index >95th percentile~Propofol: Each Obese child/subject in this group will receive a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)"
11038045|NCT01242371|BG000|Baseline|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
11038046|NCT01242371|BG001|Baseline|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
11038047|NCT01242371|BG002|Baseline|Total|Total of all reporting groups
11038048|NCT01242371|FG000|Participant Flow|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
11038049|NCT01242371|FG001|Participant Flow|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
11038050|NCT01242371|OG000|Outcome|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
11038051|NCT01242371|OG001|Outcome|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
11038052|NCT01242371|EG000|Reported Event|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
11038053|NCT01242371|EG001|Reported Event|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
11038054|NCT01242514|BG000|Baseline|Fostamatinib 100 mg Bid|Oral treatment
11038055|NCT01242514|BG001|Baseline|Fostamatinib 150 mg qd|Oral treatment
11038056|NCT01242514|BG002|Baseline|Fostamatinib 100 mg qd|Oral treatment
11038057|NCT01242514|BG003|Baseline|Total|Total of all reporting groups
11038058|NCT01242514|FG000|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
11038059|NCT01242514|FG001|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
11038060|NCT01242514|FG002|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
11038061|NCT01242514|OG000|Outcome|Fostamatinib 100 mg Bid|Oral treatment
11038062|NCT01242514|OG001|Outcome|Fostamatinib 150 mg qd|Oral treatment
11038063|NCT01242514|OG002|Outcome|Fostamatinib 100 mg qd|Oral treatment
11038064|NCT01242514|EG000|Reported Event|FOSTA 100 MG BID|
11038065|NCT01242514|EG001|Reported Event|FOSTA 100 MG QD|
11038066|NCT01242514|EG002|Reported Event|FOSTA 150 MG QD|
11038067|NCT01242527|BG000|Baseline|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
11038068|NCT01242527|BG001|Baseline|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
11038069|NCT01242527|BG002|Baseline|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
11038070|NCT01242527|BG003|Baseline|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
11038071|NCT01242527|BG004|Baseline|Total|Total of all reporting groups
11038072|NCT01242527|FG000|Participant Flow|Olive Oil (Placebo Control)|placebo : 4 capsules (1g) daily for 12 weeks
11038073|NCT01242527|FG001|Participant Flow|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
11038074|NCT01242527|FG002|Participant Flow|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
11038075|NCT01242527|FG003|Participant Flow|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
11038076|NCT01242527|OG000|Outcome|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
11038077|NCT01242527|OG001|Outcome|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
11038078|NCT01242527|OG002|Outcome|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
11038079|NCT01242527|OG003|Outcome|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
11038080|NCT01242527|EG000|Reported Event|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
11038081|NCT01242527|EG001|Reported Event|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
11038082|NCT01242527|EG002|Reported Event|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
11038083|NCT01242527|EG003|Reported Event|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
11038084|NCT01242644|BG000|Baseline|Pain Pump , Injectable Medication|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;~pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour"
11038085|NCT01242644|BG001|Baseline|Saline Pain Pump , Injectable Medication|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour~saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour"
11038086|NCT01242644|BG002|Baseline|Injectable Medication Only|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.~ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected"
11038087|NCT01242644|BG003|Baseline|Total|Total of all reporting groups
11038088|NCT01242644|FG000|Participant Flow|Pain Pump , Injectable Medication|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;~pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour"
11038089|NCT01242644|FG001|Participant Flow|Saline Pain Pump , Injectable Medication|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour~saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour"
11038090|NCT01242644|FG002|Participant Flow|Injectable Medication Only|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.~ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected"
11038091|NCT01242644|OG000|Outcome|Pain Pump , Injectable Medication|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;~pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour"
11038092|NCT01242644|OG001|Outcome|Saline Pain Pump , Injectable Medication|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour~saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour"
11038093|NCT01242644|OG002|Outcome|Injectable Medication Only|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.~ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected"
11038094|NCT01242644|EG000|Reported Event|Pain Pump , Injectable Medication|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;~pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour"
11226825|NCT02378220|EG001|Reported Event|"Intervention (Tested)"|"Patients in the tested group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.~Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System"
11038095|NCT01242644|EG001|Reported Event|Saline Pain Pump , Injectable Medication|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour~saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour"
11038096|NCT01242644|EG002|Reported Event|Injectable Medication Only|"30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.~ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected"
11038097|NCT01242748|BG000|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
11038098|NCT01242748|BG001|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
11038099|NCT01242748|BG002|Baseline|Total|Total of all reporting groups
11038100|NCT01242748|FG000|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
11038101|NCT01242748|FG001|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
11038102|NCT01242748|OG000|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
11038103|NCT01242748|OG001|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
11038104|NCT01242748|EG000|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
11038105|NCT01242748|EG001|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
11038106|NCT01242813|BG000|Baseline|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
11038107|NCT01242813|FG000|Participant Flow|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare.
11038108|NCT01242813|OG000|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
11038109|NCT01242813|EG000|Reported Event|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
11038110|NCT01243112|BG000|Baseline|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
11038111|NCT01243112|FG000|Participant Flow|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
11038112|NCT01243112|OG000|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
11038113|NCT01243112|EG000|Reported Event|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
11038114|NCT01243151|BG000|Baseline|Placebo|Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038115|NCT01243151|BG001|Baseline|PF-04950615 0.25 mg/kg|Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038116|NCT01243151|BG002|Baseline|PF-04950615 0.50 mg/kg|Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038117|NCT01243151|BG003|Baseline|PF-04950615 1.0 mg/kg|Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038118|NCT01243151|BG004|Baseline|PF-04950615 1.50 mg/kg|Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
11038119|NCT01243151|BG005|Baseline|Total|Total of all reporting groups
11038120|NCT01243151|FG000|Participant Flow|Placebo|Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038121|NCT01243151|FG001|Participant Flow|PF-04950615 0.25 mg/kg|Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038122|NCT01243151|FG002|Participant Flow|PF-04950615 0.50 mg/kg|Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038123|NCT01243151|FG003|Participant Flow|PF-04950615 1.0 mg/kg|Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038124|NCT01243151|FG004|Participant Flow|PF-04950615 1.5 mg/kg|Participants received PF-04950615 1.5 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038125|NCT01243151|OG000|Outcome|Placebo|Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038126|NCT01243151|OG001|Outcome|PF-04950615 0.25 mg/kg|Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038127|NCT01243151|OG002|Outcome|PF-04950615 0.50 mg/kg|Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038128|NCT01243151|OG003|Outcome|PF-04950615 1.0 mg/kg|Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038129|NCT01243151|OG004|Outcome|PF-04950615 1.50 mg/kg|Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
11038130|NCT01243151|OG000|Outcome|PF-04950615 0.25 mg/kg|Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038131|NCT01243151|OG001|Outcome|PF-04950615 0.50 mg/kg|Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038132|NCT01243151|OG002|Outcome|PF-04950615 1.0 mg/kg|Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038133|NCT01243151|OG003|Outcome|PF-04950615 1.50 mg/kg|Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
11038134|NCT01243151|EG000|Reported Event|Placebo|Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038135|NCT01243151|EG001|Reported Event|PF-04950615 0.25 mg/kg|Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038136|NCT01243151|EG002|Reported Event|PF-04950615 0.50 mg/kg|Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
11038137|NCT01243151|EG003|Reported Event|PF-04950615 1.00 mg/kg|Participants recieved a single dose of PF-04950615 1.0 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
11038138|NCT01243151|EG004|Reported Event|PF-04950615 1.50 mg/kg|Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
11038139|NCT01243177|BG000|Baseline|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
11038140|NCT01243177|BG001|Baseline|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
11038141|NCT01243177|BG002|Baseline|Total Title|
11038142|NCT01243177|FG000|Participant Flow|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
11038143|NCT01243177|FG001|Participant Flow|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
11038144|NCT01243177|OG000|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
11038145|NCT01243177|OG001|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
11038146|NCT01243177|EG000|Reported Event|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
11038147|NCT01243177|EG001|Reported Event|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
11038148|NCT01243242|BG000|Baseline|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
11038149|NCT01243242|BG001|Baseline|Placebo|Eligible subjects who received 1400 mg of Placebo
11038150|NCT01243242|BG002|Baseline|Total|Total of all reporting groups
11038151|NCT01243242|FG000|Participant Flow|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
11038152|NCT01243242|FG001|Participant Flow|Placebo|Eligible subjects who received 1400 mg of Placebo
11038153|NCT01243242|OG000|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
11038154|NCT01243242|OG001|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
11038155|NCT01243242|EG000|Reported Event|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
11038156|NCT01243242|EG001|Reported Event|Placebo|Eligible subjects who received 1400 mg of Placebo
11038157|NCT01243268|BG000|Baseline|Twynsta® Tablets|"Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.~Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine."
11038158|NCT01243268|FG000|Participant Flow|Twynsta® Tablets|"Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.~Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine."
11038159|NCT01243268|OG000|Outcome|Twynsta® Tablets|"Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.~Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine."
11038160|NCT01243268|EG000|Reported Event|Twynsta® Tablets|"Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.~Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine."
11038161|NCT01243294|BG000|Baseline|Entire Study Population|Includes groups randomized to receive SS (new ostomy bag)first and SenSura first
11038162|NCT01243294|FG000|Participant Flow|SenSura First, Then SS|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
11038163|NCT01243294|FG001|Participant Flow|SS First, Then SenSura|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
11038164|NCT01243294|OG000|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
11038165|NCT01243294|OG001|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
11038166|NCT01243294|EG000|Reported Event|SenSura|Base plates applied 1 till 6 times a day
11038167|NCT01243294|EG001|Reported Event|SS (New Ostomy Bag)|Base plates applied 1 till 6 times a day SS = new ostomy bag
11038168|NCT01243320|BG000|Baseline|All Study Participants|10 ppm Silver, then 32 ppm Silver
11038169|NCT01243320|FG000|Participant Flow|All Study Participants|Study had two dosing phases. All study participants were assigned the 10ppm Oral Silver and proceed to the 32 pm Oral Silver.
11038170|NCT01243320|OG000|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
11038171|NCT01243320|OG001|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
11038172|NCT01243320|EG000|Reported Event|10ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
11038173|NCT01243320|EG001|Reported Event|32ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
11038174|NCT01243333|BG000|Baseline|All Patients: Multi-Tracer PET Scans|Patients undergo PET scans with [F-18]fluorodeoxyglucose and [F-18]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
11038175|NCT01243333|FG000|Participant Flow|All Patients: Multi-Tracer PET Scans|Patients undergo Positron Emission Tomography (PET) scans with [F-18]fluorodeoxyglucose and [F-18]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
11038176|NCT01243333|OG000|Outcome|All Patients: Multi-Tracer PET Scans|Patients undergo PET scans with [F-18]fluorodeoxyglucose and [F-18]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
11038177|NCT01243333|EG000|Reported Event|All Patients: Multi-Tracer PET Scans|Patients undergo PET scans with [F-18]fluorodeoxyglucose and [F-18]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
11038178|NCT01243411|BG000|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
11038179|NCT01243411|FG000|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
11038180|NCT01243411|OG000|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
11038181|NCT01243411|EG000|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
11038182|NCT01243424|BG000|Baseline|Linagliptin|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038183|NCT01243424|BG001|Baseline|Glimepiride|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038184|NCT01243424|BG002|Baseline|Total|Total of all reporting groups
11038185|NCT01243424|FG000|Participant Flow|Linagliptin|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038186|NCT01243424|FG001|Participant Flow|Glimepiride|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038187|NCT01243424|OG000|Outcome|Linagliptin|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038188|NCT01243424|OG001|Outcome|Glimepiride|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038189|NCT01243424|OG000|Outcome|All Participants|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose or 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. All doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038190|NCT01243424|EG000|Reported Event|Linagliptin|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038191|NCT01243424|EG001|Reported Event|Glimepiride|After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
11038192|NCT01243450|BG000|Baseline|Active Generic|Active generic group
11038193|NCT01243450|BG001|Baseline|Brand|Brand group
11038194|NCT01243450|BG002|Baseline|Placebo|Placebo group
11038195|NCT01243450|BG003|Baseline|Total|Total of all reporting groups
11038196|NCT01243450|FG000|Participant Flow|Active Generic|"active cream~Tretinoin: Topical skin"
11038197|NCT01243450|FG001|Participant Flow|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
11038198|NCT01243450|FG002|Participant Flow|Brand|Tretinoin: Topical skin
11038199|NCT01243450|OG000|Outcome|Active Generic|"active cream~Tretinoin: Topical skin"
11038200|NCT01243450|OG001|Outcome|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
11038201|NCT01243450|OG002|Outcome|Brand|Tretinoin: Topical skin
11038202|NCT01243450|EG000|Reported Event|Active Generic|"active cream~Tretinoin: Topical skin"
11038203|NCT01243450|EG001|Reported Event|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
11038204|NCT01243450|EG002|Reported Event|Brand|Tretinoin: Topical skin
11038205|NCT01243567|BG000|Baseline|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
11226826|NCT02378402|BG000|Baseline|Unstable HF Group|"Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF<50%. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11038206|NCT01243567|BG001|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
11038207|NCT01243567|BG002|Baseline|Total|Total of all reporting groups
11038208|NCT01243567|FG000|Participant Flow|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
11038209|NCT01243567|FG001|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
11038210|NCT01243567|OG000|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
11038211|NCT01243567|OG001|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
11038212|NCT01243567|EG000|Reported Event|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
11038213|NCT01243567|EG001|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
11038214|NCT01243580|BG000|Baseline|AG200-15/Ortho-Cyclen®|Subject applied AG200-15 in cycle 1. Subjects applied AG200-15 (Cycle 2) followed by oral contraceptive, Ortho-Cyclen® (Cycle 3)
11038215|NCT01243580|BG001|Baseline|Ortho-Cyclen® /AG200-15|Subject applied AG200-15 in cycle 1. Subjects received Ortho-Cyclen® (Cycle 2) followed by AG200-15 (Cycle 3).
11038216|NCT01243580|BG002|Baseline|Total|Total of all reporting groups
11038217|NCT01243580|FG000|Participant Flow|AG200-15/Ortho-Cyclen®|AG200-15 transdermal contraceptive delivery system, delivering 25-30 mcg ethinyl estradiol/ 100-120 mcg levonorgestrel per day, was applied weekly for 3 consecutive weeks and was removed on the 4th week for a patch free week. This regimen occurred for Cycles 1 and 2. For cycle 3, Ortho-Cyclen® containing 250 mcg norgestimate and 35 mcg ethinyl estradiol was taken daily for 21 days followed by a drug free interval of 7 days.
11038218|NCT01243580|FG001|Participant Flow|Ortho-Cyclen®/AG200-15|AG200-15 transdermal contraceptive delivery system, delivering 25-30 mcg ethinyl estradiol and 100-120 mcg levonorgestrel per day, was applied for 3 consecutive weeks and removed on the 4th week for a patch free week. This regimen occurred for Cycle 1 and Cycle 3. Ortho-Cyclen®, containing 250 mcg norgestimate and 35 mcg ethinyl estradiol, was taken daily for 21 days followed by a drug free interval of 7 days for Cycle 2.
11038219|NCT01243580|OG000|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
11038220|NCT01243580|OG001|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of levonorgestrel (LNG) and 25 - 30 mcg EE"
11038221|NCT01243580|OG001|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
11038222|NCT01243580|OG000|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
11038223|NCT01243580|EG000|Reported Event|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
11038224|NCT01243580|EG001|Reported Event|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
11038225|NCT01243593|BG000|Baseline|Treatment Group|Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
11038226|NCT01243593|BG001|Baseline|Control Group|Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
11038227|NCT01243593|BG002|Baseline|Total|Total of all reporting groups
11038228|NCT01243593|FG000|Participant Flow|Treatment Group|Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
11038229|NCT01243593|FG001|Participant Flow|Control Group|Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
11038230|NCT01243593|OG000|Outcome|Treatment Group|Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
11038231|NCT01243593|OG001|Outcome|Control Group|Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
11038232|NCT01243593|EG000|Reported Event|Treatment Group|Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
11038233|NCT01243593|EG001|Reported Event|Control Group|Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
11038234|NCT01243619|BG000|Baseline|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
11038235|NCT01243619|FG000|Participant Flow|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
11038236|NCT01243619|OG000|Outcome|All Participants|"All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.~All patients accepted and complied with having three sets of PET scans performed (six total PET scans).~The software used in this protocol has allowed quantitative comparison among the PET scans."
11038237|NCT01243619|EG000|Reported Event|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
11038238|NCT01243671|BG000|Baseline|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
11038239|NCT01243671|FG000|Participant Flow|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
11038240|NCT01243671|OG000|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
11038241|NCT01243671|EG000|Reported Event|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
11038242|NCT01243762|BG000|Baseline|Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038243|NCT01243762|BG001|Baseline|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038244|NCT01243762|BG002|Baseline|Dalotuzumab 10 mg/kg + MK-2206 90 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038245|NCT01243762|BG003|Baseline|Dalotuzumab 10 mg/kg + MK-2206 135 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038246|NCT01243762|BG004|Baseline|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038247|NCT01243762|BG005|Baseline|Dalotuzumab 10 mg/kg + MK-2206 200 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038248|NCT01243762|BG006|Baseline|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038249|NCT01243762|BG007|Baseline|Total|Total of all reporting groups
11038250|NCT01243762|FG000|Participant Flow|Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038251|NCT01243762|FG001|Participant Flow|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038252|NCT01243762|FG002|Participant Flow|Dalotuzumab 10 mg/kg + MK-2206 90 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038253|NCT01243762|FG003|Participant Flow|Dalotuzumab 10 mg/kg + MK-2206 135 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038254|NCT01243762|FG004|Participant Flow|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038255|NCT01243762|FG005|Participant Flow|Dalotuzumab 10 mg/kg + MK-2206 200 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038256|NCT01243762|FG006|Participant Flow|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038257|NCT01243762|OG000|Outcome|Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038258|NCT01243762|OG001|Outcome|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038259|NCT01243762|OG002|Outcome|Dalotuzumab 10 mg/kg + MK-2206 90 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038260|NCT01243762|OG003|Outcome|Dalotuzumab 10 mg/kg + MK-2206 135 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038261|NCT01243762|OG004|Outcome|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038262|NCT01243762|OG005|Outcome|Dalotuzumab 10 mg/kg + MK-2206 200 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038263|NCT01243762|OG006|Outcome|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038264|NCT01243762|OG000|Outcome|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038265|NCT01243762|OG001|Outcome|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038266|NCT01243762|OG002|Outcome|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038267|NCT01243762|EG000|Reported Event|Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038268|NCT01243762|EG001|Reported Event|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038269|NCT01243762|EG002|Reported Event|Dalotuzumab 10 mg/kg + MK-2206 90 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038270|NCT01243762|EG003|Reported Event|Dalotuzumab 10 mg/kg + MK-2206 135 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038271|NCT01243762|EG004|Reported Event|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038272|NCT01243762|EG005|Reported Event|Dalotuzumab 10 mg/kg + MK-2206 200 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038273|NCT01243762|EG006|Reported Event|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
11038274|NCT01243775|BG000|Baseline|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
11038275|NCT01243775|FG000|Participant Flow|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
11038276|NCT01243775|OG000|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
11038277|NCT01243775|EG000|Reported Event|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
11038278|NCT01243944|BG000|Baseline|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
11038279|NCT01243944|BG001|Baseline|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
11038280|NCT01243944|BG002|Baseline|Total|Total of all reporting groups
11038281|NCT01243944|FG000|Participant Flow|Ruxolitinib|Starting dose of 10 mg twice a day (BID) with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy
11038282|NCT01243944|FG001|Participant Flow|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
11038283|NCT01243944|OG000|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
11038284|NCT01243944|OG001|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
11038285|NCT01243944|EG000|Reported Event|Ruxolitinib - Through Week 32|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
11038286|NCT01243944|EG001|Reported Event|Best Available Therapy - Through Week 32|Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
11038287|NCT01243944|EG002|Reported Event|Ruxolitinib - Week 256 Close Out|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
11038288|NCT01243957|BG000|Baseline|LY2216684 + Fluoxetine|"LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.~Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)."
11038289|NCT01243957|FG000|Participant Flow|LY2216684 + Fluoxetine|"LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.~Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)."
11038290|NCT01243957|OG000|Outcome|LY2216684 + Fluoxetine|"LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.~Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)."
11038291|NCT01243957|EG000|Reported Event|LY2216684|LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.
11038292|NCT01243957|EG001|Reported Event|Fluoxetine|Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).
11038293|NCT01243957|EG002|Reported Event|LY2216684 + Fluoxetine|"LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.~Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)."
11038294|NCT01244035|BG000|Baseline|All Participants, All Sequences|A: MK-8266 1.3 mg BID, B: MK-8266 0.9 mg FDD, C: Placebo
11038295|NCT01244035|FG000|Participant Flow|Sequence ABC|MK-8266 1.3 mg BID, then MK-8266 0.9 mg FDD, then Placebo
11038296|NCT01244035|FG001|Participant Flow|Sequence ACB|MK-8266 1.3 mg BID, then Placebo, then MK-8266 0.9 mg FDD
11038297|NCT01244035|FG002|Participant Flow|Sequence BCA|MK-8266 0.9 mg FDD, then Placebo, then MK-8266 1.3 mg BID
11038298|NCT01244035|FG003|Participant Flow|Sequence BAC|MK-8266 0.9 mg FDD, then MK-8266 1.3 mg BID, then Placebo
11038299|NCT01244035|FG004|Participant Flow|Sequence CAB|Placebo, then MK-8266 1.3 mg BID, then MK-8266 0.9 mg FDD
11038300|NCT01244035|FG005|Participant Flow|Sequence CBA|Placebo, then MK-8266 0.9 mg FDD, then MK-8266 1.3 mg BID
11038301|NCT01244035|OG000|Outcome|MK-8266 1.3 mg BID|Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
11038302|NCT01244035|OG001|Outcome|MK-8266 0.9 mg FDD|Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
11038303|NCT01244035|OG002|Outcome|MK-8266 1 mg QD|Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
11038304|NCT01244035|OG003|Outcome|Placebo|Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
11038305|NCT01244035|OG000|Outcome|MK-8266 1.3 mg BID; MK-8266 1 mg QD|Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
11038306|NCT01244035|OG001|Outcome|MK-8266 0.9 mg FDD; MK-8266 1 mg QD|Participants receiving MK-8266 0.9 mg FDD on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
11038307|NCT01244035|OG000|Outcome|MK-8266 1.3 mg BID|All Treatment Sequences (A, B, C) for Day 1 to Day 3
11038308|NCT01244035|OG001|Outcome|MK-8266 0.9 mg FDD|All Treatment Sequences (A, B, C) for Day 1 to Day 3
11038309|NCT01244035|OG001|Outcome|MK-8266 0.9 mg FDD; MK-8266 1 mg QD|Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
11038310|NCT01244035|OG000|Outcome|MK-1.3 mg BID; MK-8266 1 mg QD|Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
11038311|NCT01244035|OG001|Outcome|MK-8266 0.9 mg FDD, MK-8266 1 mg QD|Participants receiving MK-8266 0.9 mg FDD on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
11038312|NCT01244035|OG000|Outcome|MK-8266 0.9 mg FDD|MK-8266 administered as 0.1 mg every 2 hours (total dose of 0.9 mg) on Days 1, 2, and 3
11038313|NCT01244035|OG001|Outcome|MK-8266 1.3 mg BID|MK-8266 administered as 1.0 mg in the morning + 0.3 mg 8 hours later on Days 1, 2, and 3
11038314|NCT01244035|OG002|Outcome|Placebo|Matching placebo administered at time points matching administration of MK-8266 on Days 1, 2, and 3
11038315|NCT01244035|EG000|Reported Event|MK-8266 1.3 mg BID|MK-8266 administered as 1.0 mg in the morning + 0.3 mg 8 hours later on Days 1, 2, and 3
11038316|NCT01244035|EG001|Reported Event|MK-8266 0.9 mg FDD|MK-8266 administered as 0.1 mg every 2 hours on Days 1, 2, and 3
11038317|NCT01244035|EG002|Reported Event|MK-8266 1 mg QD|MK-8266 administered a single 1 mg dose on Day 4
11038318|NCT01244035|EG003|Reported Event|Placebo|Placebo matching MK-8266 administered on Days 1, 2, 3 and 4
11038319|NCT01244061|BG000|Baseline|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
11038320|NCT01244061|BG001|Baseline|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
11038321|NCT01244061|BG002|Baseline|Total|Total of all reporting groups
11038322|NCT01244061|FG000|Participant Flow|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
11038323|NCT01244061|FG001|Participant Flow|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
11038324|NCT01244061|OG000|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
11038325|NCT01244061|OG001|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
11038326|NCT01244061|EG000|Reported Event|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
11038327|NCT01244061|EG001|Reported Event|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
11038328|NCT01244126|BG000|Baseline|IM Morphine|0.1 mg/kg morphine IM
11038329|NCT01244126|BG001|Baseline|IV Morphine|0.1 mg/kg morphine IV
11038330|NCT01244126|BG002|Baseline|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
11038331|NCT01244126|BG003|Baseline|Total|Total of all reporting groups
11226146|NCT02372006|OG000|Outcome|Dose Finding - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
10848905|NCT00292370|EG000|Reported Event|Arm 1: Open Label (OL) Paroxetine|"In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.~Open Label (OL) Paroxetine: Open-label Paroxetine"
11038332|NCT01244126|FG000|Participant Flow|IM Morphine|0.1 mg/kg morphine IM
11038333|NCT01244126|FG001|Participant Flow|IV Morphine|0.1 mg/kg morphine IV
11038334|NCT01244126|FG002|Participant Flow|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
11038335|NCT01244126|OG000|Outcome|IM Morphine|0.1 mg/kg morphine IM
11038336|NCT01244126|OG001|Outcome|IV Morphine|0.1 mg/kg morphine IV
11038337|NCT01244126|OG002|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
11038338|NCT01244126|EG000|Reported Event|IM Morphine|0.1 mg/kg morphine IM
11038339|NCT01244126|EG001|Reported Event|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
11038340|NCT01244126|EG002|Reported Event|IV Morphine|0.1 mg/kg morphine IV
11038341|NCT01244191|BG000|Baseline|Tivantinib and Erlotinib|Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
11038342|NCT01244191|BG001|Baseline|Placebo and Erlotinib|Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
11038343|NCT01244191|BG002|Baseline|Total|Total of all reporting groups
11038344|NCT01244191|FG000|Participant Flow|Tivantinib and Erlotinib|Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
11038345|NCT01244191|FG001|Participant Flow|Placebo and Erlotinib|Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
11038346|NCT01244191|OG000|Outcome|Tivantinib and Erlotinib|Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
11038347|NCT01244191|OG001|Outcome|Placebo and Erlotinib|Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
11038348|NCT01244191|EG000|Reported Event|Tivantinib and Erlotinib|Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
11038349|NCT01244191|EG001|Reported Event|Placebo and Erlotinib|Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
11038350|NCT01244243|BG000|Baseline|Active Therapy|"All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.~Hand & Wrist Assisting Robotic Device: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks."
11038351|NCT01244243|FG000|Participant Flow|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
11038352|NCT01244243|OG000|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
11038353|NCT01244243|EG000|Reported Event|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
11038354|NCT01244412|BG000|Baseline|Imaged Subjects|
11038355|NCT01244412|FG000|Participant Flow|Imaged Subjects|Subjects imaged with hand held device
11038356|NCT01244412|OG000|Outcome|Imaged Subjects|
11038357|NCT01244412|EG000|Reported Event|Imaged Subjects|
11038358|NCT01244425|BG000|Baseline|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
11038359|NCT01244425|BG001|Baseline|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
11038360|NCT01244425|BG002|Baseline|Total|Total of all reporting groups
11038361|NCT01244425|FG000|Participant Flow|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
11038362|NCT01244425|FG001|Participant Flow|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
11038363|NCT01244425|OG000|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4 minutes after application of the study treatment.
11038364|NCT01244425|OG001|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 4 minutes after application of the study treatment.
11038365|NCT01244425|OG000|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 6 minutes after application of the study treatment.
11038366|NCT01244425|OG001|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 6 minutes after application of the study treatment.
11038367|NCT01244425|OG000|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 8 minutes after application of the study treatment.
11038368|NCT01244425|OG001|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 8 minutes after application of the study treatment.
11038369|NCT01244425|OG000|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 10 minutes after application of the study treatment.
11038370|NCT01244425|OG001|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 10 minutes after application of the study treatment.
11038371|NCT01244425|OG000|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
11038372|NCT01244425|OG001|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
11038373|NCT01244425|EG000|Reported Event|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
11038374|NCT01244425|EG001|Reported Event|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
11038375|NCT01244451|BG000|Baseline|Bendofa|Bendamustine + Ofatumumab
11038376|NCT01244451|FG000|Participant Flow|Bendofa|Bendamustine + Ofatumumab
11038377|NCT01244451|OG000|Outcome|Bendofa|Bendamustine + Ofatumumab
11038378|NCT01244451|OG000|Outcome|Study Group|Number of patients experiencing 3 or >3 AEs (both hematological and not hematological)
11038379|NCT01244451|EG000|Reported Event|Study Group|
11038380|NCT01244477|BG000|Baseline|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
11038381|NCT01244477|BG001|Baseline|Treatment-as-Usual|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
11038382|NCT01244477|BG002|Baseline|Total|Total of all reporting groups
11038383|NCT01244477|FG000|Participant Flow|CPT-C|Group Cognitive Processing Therapy-C (CPT-C): Participants who chose to participate in a 12-week CPT-C treatment group.
11038384|NCT01244477|FG001|Participant Flow|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
11038385|NCT01244477|OG000|Outcome|Arm 1: CPT-C Group|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
11038386|NCT01244477|OG001|Outcome|Arm 2: Waitlist Control Group|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
11038387|NCT01244477|OG000|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
10848906|NCT00292370|EG001|Reported Event|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Placebo: Double-blind placebo taken with OL paroxetine"
11038388|NCT01244477|OG001|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
11038389|NCT01244477|EG000|Reported Event|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
11038390|NCT01244477|EG001|Reported Event|Treatment-as-Usual|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
11038391|NCT01244490|BG000|Baseline|Placebo|Once daily
11038392|NCT01244490|BG001|Baseline|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
11038393|NCT01244490|BG002|Baseline|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
11038394|NCT01244490|BG003|Baseline|Total|Total of all reporting groups
11038395|NCT01244490|FG000|Participant Flow|Placebo|Once daily
11038396|NCT01244490|FG001|Participant Flow|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
11038397|NCT01244490|FG002|Participant Flow|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
11038398|NCT01244490|OG000|Outcome|Placebo|Once daily
11038399|NCT01244490|OG001|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
11038400|NCT01244490|OG002|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
11038401|NCT01244490|EG000|Reported Event|Placebo|Once daily
11038402|NCT01244490|EG001|Reported Event|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
11038403|NCT01244490|EG002|Reported Event|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
11038404|NCT01244503|BG000|Baseline|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
11038405|NCT01244503|FG000|Participant Flow|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
11038406|NCT01244503|OG000|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
11038407|NCT01244503|EG000|Reported Event|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
11038408|NCT01244516|BG000|Baseline|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
11038409|NCT01244516|BG001|Baseline|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
11038410|NCT01244516|BG002|Baseline|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
11038411|NCT01244516|BG003|Baseline|Total|Total of all reporting groups
11038412|NCT01244516|FG000|Participant Flow|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
11038413|NCT01244516|FG001|Participant Flow|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
11038414|NCT01244516|FG002|Participant Flow|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
11038415|NCT01244516|OG000|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
11038416|NCT01244516|OG001|Outcome|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
11038417|NCT01244516|OG002|Outcome|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
11038418|NCT01244516|OG001|Outcome|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
11038419|NCT01244516|EG000|Reported Event|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
11038420|NCT01244516|EG001|Reported Event|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
11038421|NCT01244516|EG002|Reported Event|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
11038422|NCT01244529|BG000|Baseline|All Subjects|All subjects who where enrolled wore all intervention lenses throughout the course of the study. The specific lenses used include the following: senofilcon A (control) soft contact lens with 8.8 base; senofilcon A (control) soft contact lens with 8.4 base curve; galyfilcon A (control) soft contact lens with 8.7 base curve; galyfilcon A (control) soft contact lens with 8.3 base curve; galyfilcon A Plus (test) soft contact lens with 8.7 base curve; galyfilcon A Plus (test) soft contact lens with 8.3 base curve.
11038423|NCT01244529|FG000|Participant Flow|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
11038424|NCT01244529|OG000|Outcome|Galyfilcon A Plus (Test)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038425|NCT01244529|OG001|Outcome|Galyfilcon A (Control)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038426|NCT01244529|OG002|Outcome|Senofilcon A|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038427|NCT01244529|OG000|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038428|NCT01244529|OG001|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038429|NCT01244529|OG002|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038430|NCT01244529|OG003|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038431|NCT01244529|OG004|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038432|NCT01244529|OG005|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038433|NCT01244529|OG000|Outcome|Galyfilcon AP 8.3 BC vs Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038434|NCT01244529|OG001|Outcome|Galyfilcon AP 8.3 BC vs Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038435|NCT01244529|OG002|Outcome|Galyfilcon AP 8.7 BC vs Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038436|NCT01244529|OG003|Outcome|Galyfilcon AP 8.7 BC vs Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
11038437|NCT01244529|EG000|Reported Event|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
11038438|NCT01244633|BG000|Baseline|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
11038439|NCT01244633|FG000|Participant Flow|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
11038440|NCT01244633|OG000|Outcome|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
11038441|NCT01244633|EG000|Reported Event|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
11066502|NCT01392625|BG000|Baseline|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
11066503|NCT01392625|BG001|Baseline|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
11066504|NCT01392625|BG002|Baseline|Total|Total of all reporting groups
11066505|NCT01392625|FG000|Participant Flow|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
11066506|NCT01392625|FG001|Participant Flow|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
11066507|NCT01392625|OG000|Outcome|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
11066508|NCT01392625|OG001|Outcome|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
11066509|NCT01392625|EG000|Reported Event|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
11038442|NCT01244711|BG000|Baseline|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
11038443|NCT01244711|FG000|Participant Flow|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
11038444|NCT01244711|OG000|Outcome|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
11038445|NCT01244711|EG000|Reported Event|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
11038446|NCT01244724|BG000|Baseline|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
11038447|NCT01244724|FG000|Participant Flow|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
11038448|NCT01244724|OG000|Outcome|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
11038449|NCT01244724|EG000|Reported Event|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
11038450|NCT01244893|BG000|Baseline|All Subjects|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.
11038451|NCT01244893|FG000|Participant Flow|Acuvue Advance Plus preQ/Acuvue Advance Plus postQ|"Arm 1:~Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.~Arm 2:~Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second."
11038452|NCT01244893|FG001|Participant Flow|Acuvue Advance Plus postQ/Acuvue Advance Plus preQ|"Arm 1:~Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second.~Arm 2:~Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second."
11038453|NCT01244893|OG000|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.
11038454|NCT01244893|OG001|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
11038455|NCT01244893|OG000|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
11038456|NCT01244893|OG001|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post to qualification were worn daily for 6-8 days.
11038457|NCT01244893|OG001|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days.
11038458|NCT01244893|OG000|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-9 days.
11038459|NCT01244893|OG001|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-9 days.
11038460|NCT01244893|EG000|Reported Event|AAP PreQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
11038461|NCT01244893|EG001|Reported Event|AAP PostQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
11038462|NCT01244906|BG000|Baseline|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
11038463|NCT01244906|FG000|Participant Flow|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
11038464|NCT01244906|OG000|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
11038465|NCT01244906|EG000|Reported Event|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
11038466|NCT01244984|BG000|Baseline|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
11038467|NCT01244984|BG001|Baseline|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
11038468|NCT01244984|BG002|Baseline|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
11038469|NCT01244984|BG003|Baseline|Total|Total of all reporting groups
11038470|NCT01244984|FG000|Participant Flow|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg ) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
11038471|NCT01244984|FG001|Participant Flow|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
11038472|NCT01244984|FG002|Participant Flow|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
11038473|NCT01244984|OG000|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
11038474|NCT01244984|OG001|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
11038475|NCT01244984|OG002|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
11038476|NCT01244984|OG002|Outcome|FF 100 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
11038477|NCT01244984|EG000|Reported Event|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
11038478|NCT01244984|EG001|Reported Event|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
11038479|NCT01244984|EG002|Reported Event|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
11038480|NCT01245049|BG000|Baseline|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
11038481|NCT01245049|BG001|Baseline|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
11038482|NCT01245049|BG002|Baseline|Total|Total of all reporting groups
11038483|NCT01245049|FG000|Participant Flow|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
11038484|NCT01245049|FG001|Participant Flow|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
11038485|NCT01245049|OG000|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
11038486|NCT01245049|OG001|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
11038487|NCT01245049|EG000|Reported Event|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
11038488|NCT01245049|EG001|Reported Event|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
11038489|NCT01245062|BG000|Baseline|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
11038490|NCT01245062|BG001|Baseline|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
11038491|NCT01245062|BG002|Baseline|Total|Total of all reporting groups
11226827|NCT02378402|BG001|Baseline|Stable HF Group|"Patients with acute HF episode with hospitalization treatment within 12 months, LVEF>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11038492|NCT01245062|FG000|Participant Flow|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
11038493|NCT01245062|FG001|Participant Flow|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
11038494|NCT01245062|FG002|Participant Flow|Cross-over From Chemotherapy to Trametinib|Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
11038495|NCT01245062|OG000|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
11038496|NCT01245062|OG001|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
11038497|NCT01245062|OG000|Outcome|Cross-over From Chemotherapy to Trametinib|Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
11038498|NCT01245062|EG000|Reported Event|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
11038499|NCT01245062|EG001|Reported Event|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
11038500|NCT01245062|EG002|Reported Event|Cross-over From Chemotherapy to Trametinib|Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
11038501|NCT01245101|BG000|Baseline|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
11038502|NCT01245101|BG001|Baseline|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
11038503|NCT01245101|BG002|Baseline|Total|Total of all reporting groups
11038504|NCT01245101|FG000|Participant Flow|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
11038505|NCT01245101|FG001|Participant Flow|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
11038506|NCT01245101|OG000|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
11038507|NCT01245101|OG001|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
11038508|NCT01245101|EG000|Reported Event|Raltegravir|Raltegravir 400 mg twice a day for 16 weeks
11038509|NCT01245101|EG001|Reported Event|Observation|Observation for 16 weeks
11038510|NCT01245140|BG000|Baseline|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
11038511|NCT01245140|BG001|Baseline|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
11038512|NCT01245140|BG002|Baseline|Total|Total of all reporting groups
11038513|NCT01245140|FG000|Participant Flow|Matching Placebo|Participants received matching placebo orally once daily (QD) for up to 24 weeks.
11038514|NCT01245140|FG001|Participant Flow|Alitretinoin 30 mg|Participants received an alitretinoin 30 milligram (mg) capsule orally QD for up to 24 weeks.
11038515|NCT01245140|OG000|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
11038516|NCT01245140|OG001|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
11038517|NCT01245140|EG000|Reported Event|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
11038518|NCT01245140|EG001|Reported Event|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
11038519|NCT01245270|BG000|Baseline|Bilberry Capsule First, Then Control Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038520|NCT01245270|BG001|Baseline|Control Capsule First, Then Bilberry Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038521|NCT01245270|BG002|Baseline|Total|Total of all reporting groups
11038522|NCT01245270|FG000|Participant Flow|Single Control Capsule First Then Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11066510|NCT01392625|EG001|Reported Event|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
11066511|NCT01392677|BG000|Baseline|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
11038523|NCT01245270|FG001|Participant Flow|Single Bilberry Capsule First Then Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038524|NCT01245270|OG000|Outcome|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038525|NCT01245270|OG001|Outcome|Single Blaeberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038526|NCT01245270|OG000|Outcome|Single Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038527|NCT01245270|OG001|Outcome|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038528|NCT01245270|EG000|Reported Event|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038529|NCT01245270|EG001|Reported Event|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
11038530|NCT01245283|BG000|Baseline|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
11066512|NCT01392677|BG001|Baseline|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
11038531|NCT01245283|BG001|Baseline|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
11038532|NCT01245283|BG002|Baseline|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while assistance is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
11038533|NCT01245283|BG003|Baseline|Total|Total of all reporting groups
11038534|NCT01245283|FG000|Participant Flow|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
11038535|NCT01245283|FG001|Participant Flow|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
11038536|NCT01245283|FG002|Participant Flow|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while assistance is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
11038537|NCT01245283|OG000|Outcome|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
11038538|NCT01245283|OG001|Outcome|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
11038539|NCT01245283|OG002|Outcome|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while assistance is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
11038540|NCT01245283|OG000|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
11038541|NCT01245283|OG001|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
11038542|NCT01245283|OG002|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
11038543|NCT01245283|EG000|Reported Event|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
11038544|NCT01245283|EG001|Reported Event|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
11038545|NCT01245283|EG002|Reported Event|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while assistance is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
11038546|NCT01245374|BG000|Baseline|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
11066513|NCT01392677|BG002|Baseline|Total|Total of all reporting groups
11038547|NCT01245374|FG000|Participant Flow|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
11038548|NCT01245374|OG000|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
11038549|NCT01245374|OG000|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
11038550|NCT01245374|EG000|Reported Event|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
11038551|NCT01245387|BG000|Baseline|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
11038552|NCT01245387|FG000|Participant Flow|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
11038553|NCT01245387|OG000|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
11038554|NCT01245387|EG000|Reported Event|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
11038555|NCT01245413|BG000|Baseline|Entire Study Population|Entire study population = all participlants enrolled in the study
11038556|NCT01245413|FG000|Participant Flow|SenSura Adhesive|Sensura is an already commercially available baseplate. Designed to collect output from a stoma(e.g an ileostomy and colostomy).
11038557|NCT01245413|FG001|Participant Flow|Athena Adhesive|Athena =the new test product. The Athena in this trails is an adhesive. The intend use is collecting output from a stoma (e.g an ileostomy and colostomy).
11038558|NCT01245413|OG000|Outcome|SenSura Adhesive|Reference adhesive which is commercially available.
11038559|NCT01245413|OG001|Outcome|Athena Adhesive|New test adhesive
11038560|NCT01245413|EG000|Reported Event|SenSura Adhesive|base-plate adhesion to skin
11038561|NCT01245413|EG001|Reported Event|Athena Adhesive|Base-plate adhesion to skin
11038562|NCT01245439|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
11038563|NCT01245439|FG000|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
11038564|NCT01245439|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
11038565|NCT01245439|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
11038566|NCT01245439|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current (DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
11038567|NCT01245439|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
11038568|NCT01245595|BG000|Baseline|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
11038569|NCT01245595|BG001|Baseline|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
11038570|NCT01245595|BG002|Baseline|Total|Total of all reporting groups
11038571|NCT01245595|FG000|Participant Flow|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
11038572|NCT01245595|FG001|Participant Flow|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
11038573|NCT01245595|OG000|Outcome|Aminophylline|"Patients to receive aminophylline 5 mg/kg intravenous (IV) bolus then 1.8 mg/kg IV every six (Q6) hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
11038574|NCT01245595|OG001|Outcome|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
11038575|NCT01245595|EG000|Reported Event|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
11038576|NCT01245595|EG001|Reported Event|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
11038577|NCT01245647|BG000|Baseline|Sugar Pill, 50mg, Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
11066514|NCT01392677|FG000|Participant Flow|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
11038578|NCT01245647|BG001|Baseline|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
11038579|NCT01245647|BG002|Baseline|Total|Total of all reporting groups
11038580|NCT01245647|FG000|Participant Flow|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
11038581|NCT01245647|FG001|Participant Flow|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
11038582|NCT01245647|OG000|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
11038583|NCT01245647|OG001|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
11038584|NCT01245647|EG000|Reported Event|Sugar Pill, 50 mg Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
11038585|NCT01245647|EG001|Reported Event|Naltrexone, 50mg Pill Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
11038586|NCT01245673|BG000|Baseline|Prevnar, T Cells, Lenalidomide, MAGE A-3|"MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis.~Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0.~Day 2 Activated/costimulated autologous T cells.~Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC.~Day 100 start Lenalidomide.~Day 120 and 150 MAGE-A3 and PVC."
11038587|NCT01245673|FG000|Participant Flow|MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide,|"MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis.~Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0.~Day 2 Activated/costimulated autologous T cells.~Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC.~Day 100 start Lenalidomide.~Day 120 and 150 MAGE-A3 and PVC."
11038588|NCT01245673|OG000|Outcome|Prevnar, T Cells, Lenalidomide, MAGE A-3|All patients will receive a priming immunization with a MAGE-A3/GM-CSF vaccine with adjuvant Hiltonol® (Poly-ICLC) along with the pneumococcal conjugate vaccine/PCV control vaccine about 10 days before a steady-state mononuclear cell apheresis. Patients will then undergo hematopoietic stem cell mobilization. All patients will receive high-dose melphalan followed by hematopoietic stem cells on day 0.
11038589|NCT01245673|EG000|Reported Event|Prevnar, T Cells, Lenalidomide, MAGE A-3|"MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis.~Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0.~Day 2 Activated/costimulated autologous T cells.~Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC.~Day 100 start Lenalidomide.~Day 120 and 150 MAGE-A3 and PVC."
11038590|NCT01245699|BG000|Baseline|Phase I|Before training
11038591|NCT01245699|BG001|Baseline|Phase 2|After training.
11038592|NCT01245699|BG002|Baseline|Total|Total of all reporting groups
11038593|NCT01245699|FG000|Participant Flow|Before Training, RTAV CPR Feedback and Debriefing|Before scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing
11038594|NCT01245699|FG001|Participant Flow|After Training, RTAV CPR Feedback, and Debriefing|After scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing.
11038595|NCT01245699|OG000|Outcome|Before Training|Before scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing
11038596|NCT01245699|OG001|Outcome|After Training.|After scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing
11038597|NCT01245699|OG001|Outcome|After Training|After scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing
11038598|NCT01245699|EG000|Reported Event|Phase I|Before training
11038599|NCT01245699|EG001|Reported Event|Phase 2|After training.
11038600|NCT01245738|BG000|Baseline|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
11038601|NCT01245738|FG000|Participant Flow|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
11038602|NCT01245738|OG000|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
11038603|NCT01245738|EG000|Reported Event|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
11038604|NCT01245751|BG000|Baseline|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038605|NCT01245751|BG001|Baseline|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038606|NCT01245751|BG002|Baseline|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038607|NCT01245751|BG003|Baseline|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038608|NCT01245751|BG004|Baseline|Total|Total of all reporting groups
11038609|NCT01245751|FG000|Participant Flow|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038610|NCT01245751|FG001|Participant Flow|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038611|NCT01245751|FG002|Participant Flow|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038612|NCT01245751|FG003|Participant Flow|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038613|NCT01245751|OG000|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038614|NCT01245751|OG001|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038615|NCT01245751|OG000|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038616|NCT01245751|OG002|Outcome|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038617|NCT01245751|OG003|Outcome|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038618|NCT01245751|EG000|Reported Event|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038619|NCT01245751|EG001|Reported Event|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038620|NCT01245751|EG002|Reported Event|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038621|NCT01245751|EG003|Reported Event|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
11038622|NCT01245764|BG000|Baseline|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038623|NCT01245764|BG001|Baseline|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038624|NCT01245764|BG002|Baseline|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038625|NCT01245764|BG003|Baseline|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
11038626|NCT01245764|BG004|Baseline|Total|Total of all reporting groups
11038627|NCT01245764|FG000|Participant Flow|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038628|NCT01245764|FG001|Participant Flow|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038629|NCT01245764|FG002|Participant Flow|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038630|NCT01245764|FG003|Participant Flow|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
11038631|NCT01245764|OG000|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
11038632|NCT01245764|OG001|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
11038633|NCT01245764|OG000|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
11038634|NCT01245764|OG001|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
11038635|NCT01245764|OG000|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
11038636|NCT01245764|OG001|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
11038637|NCT01245764|OG002|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
11038638|NCT01245764|OG003|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
11038639|NCT01245764|OG000|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038640|NCT01245764|OG001|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038641|NCT01245764|OG002|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation will continue to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
11038642|NCT01245764|OG003|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
11038643|NCT01245764|EG000|Reported Event|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
11038644|NCT01245764|EG001|Reported Event|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
11038645|NCT01245764|EG002|Reported Event|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
11038646|NCT01245764|EG003|Reported Event|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.
11038647|NCT01245972|BG000|Baseline|Control|No treatment administered
11038648|NCT01245972|BG001|Baseline|PDL Setting 1|"PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes~PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings."
11038649|NCT01245972|BG002|Baseline|PDL Setting 2|"PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses~PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings."
11038650|NCT01245972|BG003|Baseline|Total|Total of all reporting groups
11038651|NCT01245972|FG000|Participant Flow|Control|No treatment administered
11038652|NCT01245972|FG001|Participant Flow|PDL Setting 1|"PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes~PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings."
11038653|NCT01245972|FG002|Participant Flow|PDL Setting 2|"PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses~PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings."
11038654|NCT01245972|OG000|Outcome|Control|No treatment administered
11038655|NCT01245972|OG001|Outcome|PDL Setting 1|"PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes~PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings."
11038656|NCT01245972|OG002|Outcome|PDL Setting 2|"PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses~PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings."
11038657|NCT01245972|EG000|Reported Event|Control|No treatment administered
11038658|NCT01245972|EG001|Reported Event|PDL Setting 1|"PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes~PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings."
11038659|NCT01245972|EG002|Reported Event|PDL Setting 2|"PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses~PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings."
11038660|NCT01246050|BG000|Baseline|Arm 1: Received HF Training|"CBOC Providers who have received HF Training~3 days of training in HF management: HF training includes didactic lectures, case discussions and interactive symposia, course materials including teaching material, textbooks, copies of HF clinical guidelines and patient education material for distribution, participation in HF Clinics and Inpatient Heart Failure Rounds.~Access to clinical pharmacist services: Including medication and disease teaching, adjustment and uptitration~Quarterly analysis of physician compliance: Individualized confidential, non-punitive feedback to providers from a set of prespecified core HF performance measures."
11038661|NCT01246050|BG001|Baseline|Arm 2: No HF Training|CBOC Providers in the same CBOC who have not received HF Training
11038662|NCT01246050|BG002|Baseline|Total|Total of all reporting groups
11038663|NCT01246050|FG000|Participant Flow|Arm 1: Received HF Training|"CBOC Providers who have received HF Training~3 days of training in HF management: HF training includes didactic lectures, case discussions and interactive symposia, course materials including teaching material, textbooks, copies of HF clinical guidelines and patient education material for distribution, participation in HF Clinics and Inpatient Heart Failure Rounds.~Access to clinical pharmacist services: Including medication and disease teaching, adjustment and uptitration~Quarterly analysis of physician compliance: Individualized confidential, non-punitive feedback to providers from a set of prespecified core HF performance measures."
11038664|NCT01246050|FG001|Participant Flow|Arm 2: No HF Training|CBOC Providers in the same CBOC who have not received HF Training
11038665|NCT01246050|OG000|Outcome|Arm 1: Received HF Training|Patients followed by CBOC Providers who have received HF Training.
11038666|NCT01246050|OG001|Outcome|Arm 2: No HF Training|Patients followed by CBOC Providers in the same CBOC who have not received HF Training
11038667|NCT01246050|EG000|Reported Event|Arm 1: Received HF Training|"CBOC Providers who have received HF Training~3 days of training in HF management: HF training includes didactic lectures, case discussions and interactive symposia, course materials including teaching material, textbooks, copies of HF clinical guidelines and patient education material for distribution, participation in HF Clinics and Inpatient Heart Failure Rounds.~Access to clinical pharmacist services: Including medication and disease teaching, adjustment and uptitration~Quarterly analysis of physician compliance: Individualized confidential, non-punitive feedback to providers from a set of prespecified core HF performance measures."
11038668|NCT01246050|EG001|Reported Event|Arm 2: No HF Training|CBOC Providers in the same CBOC who have not received HF Training
11038669|NCT01246063|BG000|Baseline|Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)|Dose Level 0: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
11038670|NCT01246063|BG001|Baseline|Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)|Dose Level 1: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
11038671|NCT01246063|BG002|Baseline|Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)|Dose Level 2: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
11038672|NCT01246063|BG003|Baseline|Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)|Dose Level 3: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
11038673|NCT01246063|BG004|Baseline|Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)|Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038674|NCT01246063|BG005|Baseline|Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)|Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038675|NCT01246063|BG006|Baseline|Total|Total of all reporting groups
11038676|NCT01246063|FG000|Participant Flow|Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)|Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
11038677|NCT01246063|FG001|Participant Flow|Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)|Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
11038678|NCT01246063|FG002|Participant Flow|Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)|Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
11038679|NCT01246063|FG003|Participant Flow|Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)|Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
11038680|NCT01246063|FG004|Participant Flow|Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)|Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038681|NCT01246063|FG005|Participant Flow|Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)|Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038682|NCT01246063|OG000|Outcome|Phase I - Part 1|"Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.~Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.~Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.~Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6."
11038683|NCT01246063|OG001|Outcome|Phase I - Part 2|Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038684|NCT01246063|OG002|Outcome|Phase 2|Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11066515|NCT01392677|FG001|Participant Flow|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
11066516|NCT01392677|OG000|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
11038685|NCT01246063|OG001|Outcome|Phase 2 (Includes Phase I - Part 2 Participants)|"Phase I Part 2 Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.~Phase 2: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib."
11038686|NCT01246063|OG000|Outcome|Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)|Dose Level 0: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
11038687|NCT01246063|OG001|Outcome|Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)|Dose Level 1: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
11038688|NCT01246063|OG002|Outcome|Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)|Dose Level 2: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
11038689|NCT01246063|OG003|Outcome|Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)|Dose Level 3: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
11038690|NCT01246063|OG004|Outcome|Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)|Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038691|NCT01246063|OG005|Outcome|Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)|Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038692|NCT01246063|EG000|Reported Event|Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)|Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
11038693|NCT01246063|EG001|Reported Event|Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)|Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
11038694|NCT01246063|EG002|Reported Event|Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)|Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
11038695|NCT01246063|EG003|Reported Event|Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)|Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
11038696|NCT01246063|EG004|Reported Event|Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)|Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038697|NCT01246063|EG005|Reported Event|Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)|Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
11038698|NCT01246076|BG000|Baseline|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
11038699|NCT01246076|FG000|Participant Flow|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
11038700|NCT01246076|OG000|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
11038701|NCT01246076|EG000|Reported Event|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
11038702|NCT01246206|BG000|Baseline|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
11066517|NCT01392677|OG001|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
11066518|NCT01392677|EG000|Reported Event|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
11038703|NCT01246206|FG000|Participant Flow|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
11038704|NCT01246206|OG000|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
11038705|NCT01246206|EG000|Reported Event|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
11038706|NCT01246258|BG000|Baseline|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
11038707|NCT01246258|FG000|Participant Flow|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
11038708|NCT01246258|OG000|Outcome|Test Group|VEMPs
11038709|NCT01246258|OG000|Outcome|Test Group|"Standard tests of balance function~Vestibular evoked myogenic potentials (VEMPs): Standard test of balance function~Utricular centrifugation test: Standard test of balance function"
11038710|NCT01246258|EG000|Reported Event|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
11038711|NCT01246349|BG000|Baseline|Treatment Group (Motivational Interviewing)|"The treatment group received Motivational Interviewing (MI), which is a client-centered, directive method of therapy aimed at enhancing a client's intrinsic motivation to change by exploring and resolving ambivalence.~MI utilizes strategies to guide the patient, as opposed to offering advice or focusing on accomplishing specific goals. For example, using reflective listening and shared decision making are common within the MI approach.~Six individual MI sessions, approximately 30 minutes in length each, were provided by a trained clinical psychology doctoral student."
11038712|NCT01246349|BG001|Baseline|Control (Social Skills Training)|"The control group received social skills training in place of Motivational Interviewing (MI). The social skills training was provided by a therapist who was not trained in MI to avoid cross-contamination.~The social skills training provided was a standardized and manualized treatment, developed and validated for children and adolescents. As part of this training, the interventionist offered advice and clients were assigned specific tasks to work on. No consideration of clients' readiness to change was made in this group."
11038713|NCT01246349|BG002|Baseline|Total|Total of all reporting groups
11038714|NCT01246349|FG000|Participant Flow|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients' readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
11038715|NCT01246349|FG001|Participant Flow|Treatment/Experimental Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
11038716|NCT01246349|OG000|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients' readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
11038717|NCT01246349|OG001|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
11066519|NCT01392677|EG001|Reported Event|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
11066520|NCT01392703|BG000|Baseline|All Treated|
11038718|NCT01246349|EG000|Reported Event|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients' readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
11038719|NCT01246349|EG001|Reported Event|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
11038720|NCT01246401|BG000|Baseline|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
11038721|NCT01246401|BG001|Baseline|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
11038722|NCT01246401|BG002|Baseline|Total|Total of all reporting groups
11038723|NCT01246401|FG000|Participant Flow|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
11038724|NCT01246401|FG001|Participant Flow|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
11038725|NCT01246401|OG000|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
11038726|NCT01246401|OG001|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
11038727|NCT01246401|OG000|Outcome|Placebo + Participants With 3 or Fewer XR-NTX Injections|All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections
11038728|NCT01246401|OG001|Outcome|4 or More XR-NTX Injections|All participants who received 4 or more XR-NTX injections
11038729|NCT01246401|EG000|Reported Event|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
11038730|NCT01246401|EG001|Reported Event|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
11038731|NCT01246466|BG000|Baseline|AtriCure Bipolar System Combined With a Catheter Ablation|"Procedure using the AtriCure Bipolar System plus a catheter ablation~Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation"
11038732|NCT01246466|FG000|Participant Flow|AtriCure Bipolar System Combined With a Catheter Ablation|"Procedure using the AtriCure Bipolar System plus a catheter ablation~Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation"
11038733|NCT01246466|OG000|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Procedure using the AtriCure Bipolar System plus a catheter ablation~Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation"
11038734|NCT01246466|OG000|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"procedure using the AtriCure Bipolar System plus a catheter ablation~Hybrid: AtriCure Bipolar System & EP ablation procedure: AtriCure Bipolar System plus a catheter ablation"
11038735|NCT01246466|EG000|Reported Event|AtriCure Bipolar System Combined With a Catheter Ablation|"Procedure using the AtriCure Bipolar System plus a catheter ablation~Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation"
11038736|NCT01246479|BG000|Baseline|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
11038737|NCT01246479|FG000|Participant Flow|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 has given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
11038738|NCT01246479|OG000|Outcome|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
11038739|NCT01246479|EG000|Reported Event|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
11038740|NCT01246583|BG000|Baseline|2% CP-690,550 Ointment 1|CP-690,550 2% ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038741|NCT01246583|BG001|Baseline|Vehicle 1|Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038742|NCT01246583|BG002|Baseline|2% CP-690,550 Ointment 2|CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038743|NCT01246583|BG003|Baseline|Vehicle 2|Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks
11038744|NCT01246583|BG004|Baseline|Total|Total of all reporting groups
11038745|NCT01246583|FG000|Participant Flow|2% CP-690,550 Ointment 1|CP-690,550 2 percent (%) ointment 1, containing a dermal penetration agent, was applied topically to a 300 square centimeter (cm^2) treatment area twice daily at an application coverage of 3 milligram per cm^2 (mg/cm^2) for 4 weeks.
11038746|NCT01246583|FG001|Participant Flow|Vehicle 1|Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038747|NCT01246583|FG002|Participant Flow|2% CP-690,550 Ointment 2|CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038748|NCT01246583|FG003|Participant Flow|Vehicle 2|Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks
11038749|NCT01246583|OG000|Outcome|2% CP-690,550 Ointment 1|CP-690,550 2% ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038750|NCT01246583|OG001|Outcome|Vehicle 1|Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038751|NCT01246583|OG002|Outcome|2% CP-690,550 Ointment 2|CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038752|NCT01246583|OG003|Outcome|Vehicle 2|Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks
11038753|NCT01246583|OG001|Outcome|2% CP-690,550 Ointment 2|CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038754|NCT01246583|EG000|Reported Event|2% CP-690,550 Ointment 1|CP-690,550 2% ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038755|NCT01246583|EG001|Reported Event|Vehicle 1|Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038756|NCT01246583|EG002|Reported Event|2% CP-690,550 Ointment 2|CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
11038757|NCT01246583|EG003|Reported Event|Vehicle 2|Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks
11038758|NCT01246713|BG000|Baseline|All Study Participants|All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.
11038759|NCT01246713|FG000|Participant Flow|Solid Acetaminophen First, Then Liquid Acetaminophen|Study participants randomized to receive solid formulation first. They received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
11038760|NCT01246713|FG001|Participant Flow|Liquid Acetaminophen First, Then Solid Acetaminophen|Study participants randomized to receive liquid formulation first. They received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
11038761|NCT01246713|OG000|Outcome|Acetaminophen Solid Formulation|Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. Results for APAP-cysteinate metabolite
11038762|NCT01246713|OG001|Outcome|Acetaminophen Liquid Formulation|Subjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation. Results for APAP-cysteinate metabolite
11038763|NCT01246713|EG000|Reported Event|Solid Acetaminophen First, Then Liquid Acetaminophen|Participants in arm Solid Acetaminophen First: received a single 15mg/kg dose of a solid acetaminophen formulation first, and then a 15mg/kg dose of a liquid acetaminophen formulation after a 2 week washout period.
11038764|NCT01246713|EG001|Reported Event|Liquid Acetaminophen First, Then Solid Acetaminophen|Participants in arm Liquid Acetaminophen First: received a single 15mg/kg dose of a liquid acetaminophen formulation, and then a 15mg/kg dose of a solid acetaminophen formulation after a 2 week washout period.
11038765|NCT01246791|BG000|Baseline|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
11038766|NCT01246791|FG000|Participant Flow|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
11038767|NCT01246791|OG000|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
11038768|NCT01246791|EG000|Reported Event|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
11038769|NCT01246895|BG000|Baseline|Experimental|Microfracture with BST-CarGel
11038770|NCT01246895|BG001|Baseline|Control|Microfracture without BST-CarGel
11038771|NCT01246895|BG002|Baseline|Total|Total of all reporting groups
11038772|NCT01246895|FG000|Participant Flow|Microfracture + BST-CarGel|Microfracture with BST-CarGel
11038773|NCT01246895|FG001|Participant Flow|Microfracture Alone|Microfracture without BST-CarGel
11038774|NCT01246895|OG000|Outcome|Microfracture + BST-CarGel|Microfracture with BST-CarGel
11038775|NCT01246895|OG001|Outcome|Microfracture Alone|Microfracture without BST-CarGel
11038776|NCT01246895|OG000|Outcome|Expiremental|Microfracture with BST-CarGel
11038777|NCT01246895|OG001|Outcome|Control|Microfracture without BST-CarGel
11038778|NCT01246895|EG000|Reported Event|Microfracture + BST-CarGel|Microfracture with BST-CarGel
11038779|NCT01246895|EG001|Reported Event|Microfracture Alone|Microfracture without BST-CarGel
11038780|NCT01246960|BG000|Baseline|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
11038781|NCT01246960|BG001|Baseline|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
11038782|NCT01246960|BG002|Baseline|Total|Total of all reporting groups
11038783|NCT01246960|FG000|Participant Flow|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin 85 milligrams per square meter (mg/m^2)~Leucovorin 400 mg/m^2~5-Fluorouracil (5-FU) 400 mg/m^2 bolus~5-FU 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
11038784|NCT01246960|FG001|Participant Flow|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin 85 mg/m^2~Leucovorin 400 mg/m^2~5-FU 400 mg/m^2 bolus~5-FU 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
11038785|NCT01246960|OG000|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
11038786|NCT01246960|OG001|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
11038787|NCT01246960|EG000|Reported Event|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
11038788|NCT01246960|EG001|Reported Event|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
11038789|NCT01246973|BG000|Baseline|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
11038790|NCT01246973|BG001|Baseline|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
11038791|NCT01246973|BG002|Baseline|Total|Total of all reporting groups
11038792|NCT01246973|FG000|Participant Flow|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
11038793|NCT01246973|FG001|Participant Flow|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
11038794|NCT01246973|OG000|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
11038795|NCT01246973|OG001|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
11038796|NCT01246973|EG000|Reported Event|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
11038797|NCT01246973|EG001|Reported Event|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
11038798|NCT01246986|BG000|Baseline|Part A Cohort 1 - 160 mg LY2157299|80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle)..
11038799|NCT01246986|BG001|Baseline|Part A Cohort 2 - 300 mg LY2157299|150mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038800|NCT01246986|BG002|Baseline|Part B - 300 mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038801|NCT01246986|BG003|Baseline|Part C Cohort 1 - 160 mg LY2157299 + Sorafenib|80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038802|NCT01246986|BG004|Baseline|Part C Cohort 2 - 300 mg LY2157299 + Sorafenib|150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038803|NCT01246986|BG005|Baseline|Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab|80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).
11038804|NCT01246986|BG006|Baseline|Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab|150 mg LY2157299 given twice BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
11038805|NCT01246986|BG007|Baseline|Total|Total of all reporting groups
11038806|NCT01246986|FG000|Participant Flow|Part A Cohort 1 - 160 mg LY2157299|80 mg LY2157299 given orally twice daily (BID) for 14 days followed by 14 days off (28-day cycle).
11038807|NCT01246986|FG001|Participant Flow|Part A Cohort 2 - 300 mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038808|NCT01246986|FG002|Participant Flow|Part B - 300 mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038809|NCT01246986|FG003|Participant Flow|Part C Cohort 1 - 160 mg LY2157299 + Sorafenib|80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038810|NCT01246986|FG004|Participant Flow|Part C Cohort 2 - 300 mg LY2157299 + Sorafenib|150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038811|NCT01246986|FG005|Participant Flow|Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab|80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).
11038812|NCT01246986|FG006|Participant Flow|Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab|150 mg LY2157299 given twice orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
11038813|NCT01246986|OG000|Outcome|Part A Cohort 1 - 160 mg LY2157299|80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.
11038814|NCT01246986|OG001|Outcome|Part A Cohort 2 - 300 mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038815|NCT01246986|OG002|Outcome|Part B LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038816|NCT01246986|OG003|Outcome|Part C LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038817|NCT01246986|OG001|Outcome|Part A Cohort 2 - 300 mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 2.
11038818|NCT01246986|OG003|Outcome|Part C LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days 0ff (28-day cycle).
11038819|NCT01246986|OG000|Outcome|Part A Cohort 1 - 160 mg LY2157299|80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038820|NCT01246986|OG002|Outcome|Part B - 300 mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038821|NCT01246986|OG003|Outcome|Part C Cohort 1 - 160 mg + Sorafenib|80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib
11038822|NCT01246986|OG004|Outcome|Part C Cohort 2 - 300 mg LY2157299 + Sorafenib|150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
11038823|NCT01246986|OG000|Outcome|LY2157299|LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038824|NCT01246986|OG003|Outcome|Part C Cohort 1 - 160 mg LY2157299 + Sorafenib|80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038825|NCT01246986|OG004|Outcome|Part C Cohort 2 - 300 mg LY2157299 + Sorafenib|150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038826|NCT01246986|OG002|Outcome|Part B - 300 mg LY2157299|150 mg LY2157299 given orally 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038827|NCT01246986|OG003|Outcome|Part C Cohort 1 - 160 mg LY2157299 + Sorafenib|80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
11038828|NCT01246986|OG003|Outcome|Part C Cohort 1 - 160 mg LY2157299 + Sorafenib|80 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle
11038829|NCT01246986|OG004|Outcome|Part C Cohort 2 - 300 mg LY2157299 + Sorafenib|150 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle
11038830|NCT01246986|OG003|Outcome|Part C Cohort 1 - 160 mg LY2157299 + Sorafenib|80 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038831|NCT01246986|OG004|Outcome|Part C Cohort 2 - 300 mg LY2157299 + Sorafenib|150 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038832|NCT01246986|OG003|Outcome|Part C Cohort 1 - 160mg LY2157299 + Sorafenib|80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).
11038833|NCT01246986|OG004|Outcome|Part C Cohort 2 - 300 mg LY2157299 + Sorafenib|150 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).
11038834|NCT01246986|OG003|Outcome|Part C Cohort 2 - 300mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038835|NCT01246986|EG000|Reported Event|Part A Cohort 1 - 160 mg LY2157299|80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038836|NCT01246986|EG001|Reported Event|Part A Cohort 2 - 300 mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038837|NCT01246986|EG002|Reported Event|Part B - 300 mg LY2157299|150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
11038838|NCT01246986|EG003|Reported Event|Part C Cohort 1 - 160 mg LY2157299 + Sorafenib|80 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038839|NCT01246986|EG004|Reported Event|Part C Cohort 2 - 300 mg LY2157299 + Sorafenib|150 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
11038840|NCT01246986|EG005|Reported Event|Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab|80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
11038841|NCT01246986|EG006|Reported Event|Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab|150 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
11038842|NCT01246999|BG000|Baseline|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
11038843|NCT01246999|BG001|Baseline|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
11038844|NCT01246999|BG002|Baseline|TIV - TIV|TIV will be given followed by TIV 28 days later
11038845|NCT01246999|BG003|Baseline|LAIV - TIV|LAIV will be given followed by TIV 28 days later
11038846|NCT01246999|BG004|Baseline|Total|Total of all reporting groups
11038847|NCT01246999|FG000|Participant Flow|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
11038848|NCT01246999|FG001|Participant Flow|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
11038849|NCT01246999|FG002|Participant Flow|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
11038850|NCT01246999|FG003|Participant Flow|TIV - TIV|TIV will be given IM followed by TIV IM
11038851|NCT01246999|OG000|Outcome|Trivalent Seasonal Live Attenuated Influenza Vaccine|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
11038852|NCT01246999|OG001|Outcome|Seasonal Influenza Vaccine (TIV-LAIV)|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
11038853|NCT01246999|OG002|Outcome|All First Dose Live Vaccine|All subjects who received LAIV as a first dose
11038854|NCT01246999|OG000|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
11038855|NCT01246999|OG001|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
11038856|NCT01246999|OG002|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
11038857|NCT01246999|OG003|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
11038858|NCT01246999|EG000|Reported Event|LAIV-LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
11038859|NCT01246999|EG001|Reported Event|TIV-LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
11038860|NCT01246999|EG002|Reported Event|LAIV-TIV|LAIV will be given intranasally followed by TIV intramuscularly
11038861|NCT01246999|EG003|Reported Event|TIV-TIV|TIV will be given IM followed by IV IM
11038862|NCT01247064|BG000|Baseline|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
11038863|NCT01247064|BG001|Baseline|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
11038864|NCT01247064|BG002|Baseline|Total|Total of all reporting groups
11038865|NCT01247064|FG000|Participant Flow|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
11038866|NCT01247064|FG001|Participant Flow|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
11038867|NCT01247064|OG000|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
11038868|NCT01247064|OG001|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
11038869|NCT01247064|EG000|Reported Event|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
11038870|NCT01247064|EG001|Reported Event|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
11038871|NCT01247090|BG000|Baseline|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
11038872|NCT01247090|BG001|Baseline|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
11038873|NCT01247090|BG002|Baseline|Placebo|No Dose - Placebo Comparator
11038874|NCT01247090|BG003|Baseline|Total|Total of all reporting groups
11038875|NCT01247090|FG000|Participant Flow|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
11038876|NCT01247090|FG001|Participant Flow|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
11038877|NCT01247090|FG002|Participant Flow|Placebo|No Dose - Placebo Comparator
11038878|NCT01247090|OG000|Outcome|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
11038879|NCT01247090|OG001|Outcome|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
11038880|NCT01247090|OG002|Outcome|Placebo|No Dose - Placebo Comparator
11038881|NCT01247090|EG000|Reported Event|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
11038882|NCT01247090|EG001|Reported Event|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
11038883|NCT01247090|EG002|Reported Event|Placebo|No Dose - Placebo Comparator
11038884|NCT01247220|BG000|Baseline|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
11038885|NCT01247220|BG001|Baseline|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
11038886|NCT01247220|BG002|Baseline|Total|Total of all reporting groups
11038887|NCT01247220|FG000|Participant Flow|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
11038888|NCT01247220|FG001|Participant Flow|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
11038889|NCT01247220|OG000|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
11038890|NCT01247220|OG001|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
11038891|NCT01247220|EG000|Reported Event|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
11038892|NCT01247220|EG001|Reported Event|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
11038893|NCT01247272|BG000|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
11038894|NCT01247272|BG001|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
11038895|NCT01247272|BG002|Baseline|Total|Total of all reporting groups
11038896|NCT01247272|FG000|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
11038897|NCT01247272|FG001|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
11038898|NCT01247272|OG000|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
11038899|NCT01247272|OG001|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
11038900|NCT01247272|EG000|Reported Event|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
11226147|NCT02372006|OG001|Outcome|Dose Finding - Level 1|"Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11226148|NCT02372006|OG002|Outcome|Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11038901|NCT01247272|EG001|Reported Event|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
11038902|NCT01247285|BG000|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
11038903|NCT01247285|BG001|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
11038904|NCT01247285|BG002|Baseline|Total|Total of all reporting groups
11038905|NCT01247285|FG000|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
11038906|NCT01247285|FG001|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
11038907|NCT01247285|OG000|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
11038908|NCT01247285|OG001|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
11038909|NCT01247285|EG000|Reported Event|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
11226828|NCT02378402|BG002|Baseline|Control Group|"Age- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11038910|NCT01247285|EG001|Reported Event|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in either period.
11038911|NCT01247298|BG000|Baseline|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
11038912|NCT01247298|FG000|Participant Flow|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
11038913|NCT01247298|OG000|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
11038914|NCT01247298|OG000|Outcome|Stereotactic Body Radiation Therapy (SBRT)|"Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.)~Stereotactic Body Radiation Therapy (SBRT): This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy."
11226829|NCT02378402|BG003|Baseline|Total|Total of all reporting groups
11038915|NCT01247298|EG000|Reported Event|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
11038916|NCT01247350|BG000|Baseline|2 mg LY3009104|2 mg administered orally once on Day 1 (single dose)
11038917|NCT01247350|BG001|Baseline|5 mg LY3009104|5 mg administered orally once on Day 1 (single dose)
11038918|NCT01247350|BG002|Baseline|10 mg LY3009104|10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)
11038919|NCT01247350|BG003|Baseline|14 mg LY3009104|14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
11038920|NCT01247350|BG004|Baseline|Placebo|administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
11038921|NCT01247350|BG005|Baseline|Total|Total of all reporting groups
11038922|NCT01247350|FG000|Participant Flow|2 mg LY3009104 (Baricitinib)|2 mg administered orally once on Day 1 (single dose)
11038923|NCT01247350|FG001|Participant Flow|5 mg LY3009104|5 mg administered orally once on Day 1 (single dose)
11038924|NCT01247350|FG002|Participant Flow|10 mg LY3009104|10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)
11038925|NCT01247350|FG003|Participant Flow|14 mg LY3009104|14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
11038926|NCT01247350|FG004|Participant Flow|Placebo|administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
11038927|NCT01247350|OG000|Outcome|2 mg LY3009104 Single Dose|2 mg administered orally once on Day 1
11038928|NCT01247350|OG001|Outcome|5 mg LY3009104 Single Dose|5 mg administered orally once on Day 1
11038929|NCT01247350|OG002|Outcome|10 mg LY3009104 Single Dose|10 mg administered orally once on Day 1
11038930|NCT01247350|OG003|Outcome|14 mg LY3009104 Single Dose|14 mg administered orally once on Day 1
11038931|NCT01247350|OG004|Outcome|Placebo Single Dose|administered orally once on Day 1
11038932|NCT01247350|OG005|Outcome|10 mg LY3009104 Multiple Dose|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
11038933|NCT01247350|OG006|Outcome|14 mg LY3009104 Multiple Dose|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
11038934|NCT01247350|OG007|Outcome|Placebo Multiple Dose|Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
11038935|NCT01247350|OG000|Outcome|2 mg LY3009104 Day 1|2 mg administered orally once on Day 1
11038936|NCT01247350|OG001|Outcome|5 mg LY3009104 Day 1|5 mg administered orally once on Day 1
11038937|NCT01247350|OG002|Outcome|10 mg LY3009104 Day 1|10 mg administered orally once on Day 1
11038938|NCT01247350|OG003|Outcome|14 mg LY3009104 Day 1|14 mg administered orally once on Day 1
11038939|NCT01247350|OG004|Outcome|10 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
11038940|NCT01247350|OG005|Outcome|14 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
11038941|NCT01247350|OG000|Outcome|10 mg LY3009104 Day 1|10 mg administered orally on Day 1
11038942|NCT01247350|OG001|Outcome|14 mg LY3009104 Day 1|14 mg administered orally on Day 1
11038943|NCT01247350|EG000|Reported Event|2 mg LY3009104 - Single Dose|2 mg administered orally once on Day 1
11038944|NCT01247350|EG001|Reported Event|5 mg LY3009104 - Single Dose|5 mg administered orally once on Day 1
11038945|NCT01247350|EG002|Reported Event|10 mg LY3009104 - Single Dose|10 mg administered orally on Day 1
11038946|NCT01247350|EG003|Reported Event|14 mg LY3009104 - Single Dose|14 mg administered orally on Day 1
11038947|NCT01247350|EG004|Reported Event|Placebo - Single Dose|administered orally on Day 1
11038948|NCT01247350|EG005|Reported Event|10 mg LY3009104 - Multiple Dose|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
11038949|NCT01247350|EG006|Reported Event|14 mg LY3009104 - Multiple Dose|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
11038950|NCT01247350|EG007|Reported Event|Placebo - Multiple Dose|Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
11038951|NCT01247363|BG000|Baseline|LY2608204|Oral capsules of LY2608204 given once daily at a starting dose of 160 mg, which was titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.
11038952|NCT01247363|FG000|Participant Flow|LY2608204|Oral capsules of LY2608204 given once daily at a starting dose of 160 mg, which was titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.
11038953|NCT01247363|OG000|Outcome|160 mg LY2608204|Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg)
11038954|NCT01247363|OG001|Outcome|240 mg LY2608204|Oral capsules of LY2608204 given once daily at dose of 240 mg
11038955|NCT01247363|OG002|Outcome|320 mg LY2608204|Oral capsules of LY2608204 given once daily at dose of 320 mg
11038956|NCT01247363|OG003|Outcome|400 mg LY2608204|Oral capsules of LY2608204 given once daily at dose of 400 mg
11038957|NCT01247363|OG000|Outcome|160 mg LY2608204 Day 1|Oral capsules of LY2608204 given once at dose of 160 milligram (mg)
11038958|NCT01247363|OG001|Outcome|160 mg LY2608204 Day 7|Oral capsules of LY2608204 given once daily at dose of 160 mg
11038959|NCT01247363|OG002|Outcome|240 mg LY2608204 Day 14|Oral capsules of LY2608204 given once daily at dose of 240 mg
11038960|NCT01247363|OG003|Outcome|320 mg LY2608204 Day 21|Oral capsules of LY2608204 given once daily at dose of 320 mg
11038961|NCT01247363|OG004|Outcome|400 mg LY2608204 Day 28|Oral capsules of LY2608204 given once daily at dose of 400 mg
11038962|NCT01247363|EG000|Reported Event|160 mg LY2608204|Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg)
11038963|NCT01247363|EG001|Reported Event|240 mg LY2608204|Oral capsules of LY2608204 given once daily at dose of 240 mg
11038964|NCT01247363|EG002|Reported Event|320 mg LY2608204|Oral capsules of LY2608204 given once daily at dose of 320 mg
11038965|NCT01247363|EG003|Reported Event|400 mg LY2608204|Oral capsules of LY2608204 given once daily at dose of 400 mg
11038966|NCT01247428|BG000|Baseline|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11038967|NCT01247428|FG000|Participant Flow|MiStent SES|The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11038968|NCT01247428|OG000|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11038969|NCT01247428|EG000|Reported Event|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11038970|NCT01247571|BG000|Baseline|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
11038971|NCT01247571|FG000|Participant Flow|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
11038972|NCT01247571|OG000|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
11038973|NCT01247571|EG000|Reported Event|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
11038974|NCT01247675|BG000|Baseline|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
11038975|NCT01247675|BG001|Baseline|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
11038976|NCT01247675|BG002|Baseline|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
11038977|NCT01247675|BG003|Baseline|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
11038978|NCT01247675|BG004|Baseline|Total|Total of all reporting groups
11038979|NCT01247675|FG000|Participant Flow|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.02 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
11038980|NCT01247675|FG001|Participant Flow|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.04 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
11038981|NCT01247675|FG002|Participant Flow|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.08 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
11038982|NCT01247675|FG003|Participant Flow|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: subcutaneous, daily injection of Omnitrope equivalent to 0.04 mg/kg/wk over 4 weeks. Prior to randomization, study subjects entered a wash out period of 14 to 21 days following cessation of daily growth hormone therapy.
11038983|NCT01247675|OG000|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
11038984|NCT01247675|OG001|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
11038985|NCT01247675|OG002|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
11038986|NCT01247675|OG003|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
11038987|NCT01247675|OG001|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk
11038988|NCT01247675|OG002|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk
11038989|NCT01247675|EG000|Reported Event|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
11038990|NCT01247675|EG001|Reported Event|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
11038991|NCT01247675|EG002|Reported Event|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk
11038992|NCT01247675|EG003|Reported Event|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
11038993|NCT01247922|BG000|Baseline|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
11038994|NCT01247922|FG000|Participant Flow|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
11038995|NCT01247922|OG000|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
11038996|NCT01247922|EG000|Reported Event|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
11038997|NCT01247974|BG000|Baseline|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
11038998|NCT01247974|BG001|Baseline|Control|No closure of pericardium
11038999|NCT01247974|BG002|Baseline|Total|Total of all reporting groups
11039000|NCT01247974|FG000|Participant Flow|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
11039001|NCT01247974|FG001|Participant Flow|Control|Pericardium is not closed
11039002|NCT01247974|OG000|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
11039003|NCT01247974|OG001|Outcome|Control|No Pericardial Closure
11039004|NCT01247974|EG000|Reported Event|CorMatrix ECM|CorMatrix ECM for Pericardial Closure
11039005|NCT01247974|EG001|Reported Event|Control|Pericardium is not closed
11039006|NCT01248013|BG000|Baseline|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
11039007|NCT01248013|FG000|Participant Flow|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
11039008|NCT01248013|OG000|Outcome|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
11039009|NCT01248013|EG000|Reported Event|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
11039010|NCT01248065|BG000|Baseline|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
11039011|NCT01248065|BG001|Baseline|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
11039012|NCT01248065|BG002|Baseline|Total|Total of all reporting groups
11039013|NCT01248065|FG000|Participant Flow|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
11039014|NCT01248065|FG001|Participant Flow|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
11039015|NCT01248065|OG000|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
11039016|NCT01248065|OG001|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
11039017|NCT01248065|EG000|Reported Event|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
11039018|NCT01248065|EG001|Reported Event|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
11039019|NCT01248104|BG000|Baseline|Tranexamic Acid|Tranexamic Acid: Infusion during cardiac surgery
11039020|NCT01248104|BG001|Baseline|Aminocaproic Acid|Aminocaproic Acid: Infusion during cardiac surgery
11039021|NCT01248104|BG002|Baseline|Total|Total of all reporting groups
11039022|NCT01248104|FG000|Participant Flow|Tranexamic Acid|Tranexamic Acid: Infusion during cardiac surgery
11039023|NCT01248104|FG001|Participant Flow|Aminocaproic Acid|Aminocaproic Acid: Infusion during cardiac surgery
11039024|NCT01248104|OG000|Outcome|Tranexamic Acid|Tranexamic Acid: Infusion during cardiac surgery
11039025|NCT01248104|OG001|Outcome|Aminocaproic Acid|Aminocaproic Acid: Infusion during cardiac surgery
11039026|NCT01248104|EG000|Reported Event|Tranexamic Acid|Tranexamic Acid: Infusion during cardiac surgery
11039027|NCT01248104|EG001|Reported Event|Aminocaproic Acid|Aminocaproic Acid: Infusion during cardiac surgery
11039028|NCT01248221|BG000|Baseline|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039029|NCT01248221|BG001|Baseline|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039030|NCT01248221|BG002|Baseline|Total|Total of all reporting groups
11039031|NCT01248221|FG000|Participant Flow|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039032|NCT01248221|FG001|Participant Flow|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039033|NCT01248221|OG000|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039034|NCT01248221|OG001|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039035|NCT01248221|OG000|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039036|NCT01248221|OG001|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039037|NCT01248221|EG000|Reported Event|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039038|NCT01248221|EG001|Reported Event|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
11039039|NCT01248364|BG000|Baseline|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039040|NCT01248364|BG001|Baseline|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039041|NCT01248364|BG002|Baseline|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039042|NCT01248364|BG003|Baseline|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
11039043|NCT01248364|BG004|Baseline|Total|Total of all reporting groups
11039044|NCT01248364|FG000|Participant Flow|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039045|NCT01248364|FG001|Participant Flow|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039046|NCT01248364|FG002|Participant Flow|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039047|NCT01248364|FG003|Participant Flow|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
11039048|NCT01248364|OG000|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039049|NCT01248364|OG001|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039050|NCT01248364|OG002|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039051|NCT01248364|OG003|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
11039052|NCT01248364|EG000|Reported Event|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039053|NCT01248364|EG001|Reported Event|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039054|NCT01248364|EG002|Reported Event|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039055|NCT01248364|EG003|Reported Event|Healthy Subjects|Healthy subjects received empagliflozin (empa) 25mg tablet once daily for 28 days.
11039056|NCT01248416|BG000|Baseline|Aromatase Inhibitor|"Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years~Aromatase Inhibitor"
11039057|NCT01248416|BG001|Baseline|Growth Hormone|"Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years~Growth Hormone"
11039058|NCT01248416|BG002|Baseline|Aromatase Inhibitor and Growth Hormone|"Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years~Aromatase Inhibitor~Growth Hormone~Aromatase Inhibitor and Growth Hormone"
11039059|NCT01248416|BG003|Baseline|Total|Total of all reporting groups
11039060|NCT01248416|FG000|Participant Flow|Aromatase Inhibitor|"Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years~Aromatase Inhibitor"
11039061|NCT01248416|FG001|Participant Flow|Growth Hormone|"Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years~Growth Hormone"
11039062|NCT01248416|FG002|Participant Flow|Aromatase Inhibitor and Growth Hormone|"Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years~Aromatase Inhibitor~Growth Hormone~Aromatase Inhibitor and Growth Hormone"
11039063|NCT01248416|OG000|Outcome|Aromatase Inhibitor|"Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years~Aromatase Inhibitor"
11039064|NCT01248416|OG001|Outcome|Growth Hormone|"Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years~Growth Hormone"
11039065|NCT01248416|OG002|Outcome|Aromatase Inhibitor and Growth Hormone|"Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years~Aromatase Inhibitor~Growth Hormone~Aromatase Inhibitor and Growth Hormone"
11039066|NCT01248416|OG000|Outcome|Anastrozole|Anastrozole 1mg for 2 to 3 years .
11039067|NCT01248416|OG001|Outcome|Letrozole|Letrozole 2.5mg daily orally for 2 to 3 years .
11039068|NCT01248416|EG000|Reported Event|Aromatase Inhibitor|"Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years~Aromatase Inhibitor"
11226830|NCT02378402|FG000|Participant Flow|Unstable HF Group|"Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF<50%. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11039069|NCT01248416|EG001|Reported Event|Growth Hormone|"Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years~Growth Hormone"
11039070|NCT01248416|EG002|Reported Event|Aromatase Inhibitor and Growth Hormone|"Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years~Aromatase Inhibitor~Growth Hormone~Aromatase Inhibitor and Growth Hormone"
11039071|NCT01248455|BG000|Baseline|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
11039072|NCT01248455|FG000|Participant Flow|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
11039073|NCT01248455|OG000|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
11039074|NCT01248455|EG000|Reported Event|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
11039075|NCT01248468|BG000|Baseline|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
11039076|NCT01248468|BG001|Baseline|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
11039077|NCT01248468|BG002|Baseline|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
11039078|NCT01248468|BG003|Baseline|Total|Total of all reporting groups
11039079|NCT01248468|FG000|Participant Flow|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
11039080|NCT01248468|FG001|Participant Flow|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
11039081|NCT01248468|FG002|Participant Flow|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
11039082|NCT01248468|OG000|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
11039083|NCT01248468|OG001|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
11039084|NCT01248468|OG002|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
11039085|NCT01248468|EG000|Reported Event|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
11039086|NCT01248468|EG001|Reported Event|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
11039087|NCT01248468|EG002|Reported Event|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
11039088|NCT01248585|BG000|Baseline|Dexamethasone|"2 x 4 mg dexamethasone tablets taken once daily for 5 days~Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days"
11039089|NCT01248585|BG001|Baseline|Placebo|"2 placebo tablets taken once daily for 5 days~Placebo: 2 placebo tablets taken once daily for 5 days"
11039090|NCT01248585|BG002|Baseline|Total|Total of all reporting groups
11039091|NCT01248585|FG000|Participant Flow|Dexamethasone|"2 x 4 mg dexamethasone tablets taken once daily for 5 days~Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days"
11039092|NCT01248585|FG001|Participant Flow|Placebo|"2 placebo tablets taken once daily for 5 days~Placebo: 2 placebo tablets taken once daily for 5 days"
11039093|NCT01248585|OG000|Outcome|Dexamethasone|"2 x 4 mg dexamethasone tablets taken once daily for 5 days~Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days"
11039094|NCT01248585|OG001|Outcome|Placebo|"2 placebo tablets taken once daily for 5 days~Placebo: 2 placebo tablets taken once daily for 5 days"
11039095|NCT01248585|EG000|Reported Event|Dexamethasone|"2 x 4 mg dexamethasone tablets taken once daily for 5 days~Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days"
11039096|NCT01248585|EG001|Reported Event|Placebo|"2 placebo tablets taken once daily for 5 days~Placebo: 2 placebo tablets taken once daily for 5 days"
11039097|NCT01248715|BG000|Baseline|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
11039098|NCT01248715|BG001|Baseline|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
11039099|NCT01248715|BG002|Baseline|Total|Total of all reporting groups
11039100|NCT01248715|FG000|Participant Flow|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
11039101|NCT01248715|FG001|Participant Flow|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
11039102|NCT01248715|OG000|Outcome|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
11039103|NCT01248715|OG001|Outcome|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
11039104|NCT01248715|EG000|Reported Event|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
11039105|NCT01248715|EG001|Reported Event|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
11039106|NCT01248728|BG000|Baseline|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
11039107|NCT01248728|BG001|Baseline|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
11039108|NCT01248728|BG002|Baseline|Total|Total of all reporting groups
11039109|NCT01248728|FG000|Participant Flow|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
11039110|NCT01248728|FG001|Participant Flow|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
11039111|NCT01248728|OG000|Outcome|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
11039112|NCT01248728|OG001|Outcome|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
11039113|NCT01248728|OG000|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
11039114|NCT01248728|OG001|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
11039115|NCT01248728|EG000|Reported Event|Omega-3 Fatty Acids|"Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.~Omega-3 Fatty Acids: Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process."
11039116|NCT01248728|EG001|Reported Event|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
11039117|NCT01248741|BG000|Baseline|Localized Prostate Cancer|Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.
11039118|NCT01248741|FG000|Participant Flow|HDR Prostate Brachytherapy|"HDR prostate brachytherapy: HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a boost combined with external beam radiotherapy"
11039119|NCT01248741|OG000|Outcome|Localized Prostate Cancer|Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.
11039120|NCT01248741|EG000|Reported Event|Localized Prostate Cancer|Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.
11039121|NCT01248780|BG000|Baseline|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
11039122|NCT01248780|BG001|Baseline|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
11039123|NCT01248780|BG002|Baseline|Total|Total of all reporting groups
11039124|NCT01248780|FG000|Participant Flow|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
11039125|NCT01248780|FG001|Participant Flow|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
11039126|NCT01248780|OG000|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
11039127|NCT01248780|OG001|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
11039128|NCT01248780|EG000|Reported Event|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escaped to receive golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48; or placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
11226831|NCT02378402|FG001|Participant Flow|Stable HF Group|"Patients with acute HF episode with hospitalization treatment within 12 months, LVEF>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11039129|NCT01248780|EG001|Reported Event|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
11039130|NCT01248793|BG000|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
11039131|NCT01248793|BG001|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
11039132|NCT01248793|BG002|Baseline|Total|Total of all reporting groups
11039133|NCT01248793|FG000|Participant Flow|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
11039134|NCT01248793|FG001|Participant Flow|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
11039135|NCT01248793|OG000|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
11039136|NCT01248793|OG001|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
11039137|NCT01248793|EG000|Reported Event|Placebo -> Golimumab 50 mg|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48
11039138|NCT01248793|EG001|Reported Event|Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
11039139|NCT01248884|BG000|Baseline|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039140|NCT01248884|BG001|Baseline|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039141|NCT01248884|BG002|Baseline|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039142|NCT01248884|BG003|Baseline|Total|Total of all reporting groups
11039143|NCT01248884|FG000|Participant Flow|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039144|NCT01248884|FG001|Participant Flow|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039145|NCT01248884|FG002|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
11039146|NCT01248884|OG000|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039147|NCT01248884|OG001|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039148|NCT01248884|OG002|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
11039149|NCT01248884|OG002|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039150|NCT01248884|OG002|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039151|NCT01248884|EG000|Reported Event|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039152|NCT01248884|EG001|Reported Event|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
11039153|NCT01248884|EG002|Reported Event|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
11039154|NCT01248936|BG000|Baseline|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
11039155|NCT01248936|FG000|Participant Flow|Overall Trial|Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
11039156|NCT01248936|OG000|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
11039157|NCT01248936|OG000|Outcome|Overall Trial|Participants received Vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, Unmanageable toxicity most probably attributable to Vemurafenib, withdrawal of consent, and Study termination by the Sponsor
11039158|NCT01248936|EG000|Reported Event|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
11039159|NCT01248949|BG000|Baseline|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
11039160|NCT01248949|BG001|Baseline|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
11039161|NCT01248949|BG002|Baseline|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
11039162|NCT01248949|BG003|Baseline|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
11039163|NCT01248949|BG004|Baseline|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
11039164|NCT01248949|BG005|Baseline|Total|Total of all reporting groups
11039165|NCT01248949|FG000|Participant Flow|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
11039166|NCT01248949|FG001|Participant Flow|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
11039167|NCT01248949|FG002|Participant Flow|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
11039168|NCT01248949|FG003|Participant Flow|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
11039169|NCT01248949|FG004|Participant Flow|MEDI3617 + CARBOPLATIN/ PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
11039170|NCT01248949|OG000|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
11039171|NCT01248949|OG001|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
11039172|NCT01248949|OG002|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
11039173|NCT01248949|OG003|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
11039174|NCT01248949|OG004|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
11039175|NCT01248949|EG000|Reported Event|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
11039176|NCT01248949|EG001|Reported Event|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
11039177|NCT01248949|EG002|Reported Event|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
11039178|NCT01248949|EG003|Reported Event|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
11039179|NCT01248949|EG004|Reported Event|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
11039180|NCT01248962|BG000|Baseline|Standard 30-minute Infusion|"This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.~carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion."
11039181|NCT01248962|BG001|Baseline|Extended 3-hour Infusion|"This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.~carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion."
11039182|NCT01248962|BG002|Baseline|Total|Total of all reporting groups
11039183|NCT01248962|FG000|Participant Flow|Standard 30-minute Infusion|"This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.~carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion."
11039184|NCT01248962|FG001|Participant Flow|Extended 3-hour Infusion|"This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.~carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion."
11039185|NCT01248962|OG000|Outcome|Standard 30-minute Infusion|"This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.~carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion."
11039186|NCT01248962|OG001|Outcome|Extended 3-hour Infusion|"This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.~carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion."
11039187|NCT01248962|OG000|Outcome|Participants Who Experienced HSR|Participants who Experienced Hypersensitivity Reaction
11348900|NCT04138810|FG000|Participant Flow|Post-op VCE|"As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The VCE group will conduct their encounter via the videoconference section of the MyChart mobile applications. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.~VCE: Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.~Survey: Measure of satisfaction regarding post-op visit."
11348901|NCT04138810|FG001|Participant Flow|Office Post-operative Visits|"As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The traditional follow up group will receive a telephone call from the office nurse as is current standard of care. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.~Survey: Measure of satisfaction regarding post-op visit."
11348902|NCT04138810|OG000|Outcome|Post-op VCE|"As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The VCE group will conduct their encounter via the videoconference section of the MyChart mobile applications. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.~VCE: Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.~Survey: Measure of satisfaction regarding post-op visit."
11348903|NCT04138810|OG001|Outcome|Office Post-operative Visits|"As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The traditional follow up group will receive a telephone call from the office nurse as is current standard of care. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.~Survey: Measure of satisfaction regarding post-op visit."
11348904|NCT04138810|EG000|Reported Event|Post-op VCE|"As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The VCE group will conduct their encounter via the videoconference section of the MyChart mobile applications. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.~VCE: Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.~Survey: Measure of satisfaction regarding post-op visit."
11039188|NCT01248962|EG000|Reported Event|Standard 30-minute Infusion|"This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.~carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion."
11039189|NCT01248962|EG001|Reported Event|Extended 3-hour Infusion|"This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.~carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion."
11039190|NCT01249027|BG000|Baseline|Observational|"Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).~XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study."
11039191|NCT01249027|FG000|Participant Flow|Observational|"Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).~XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study."
11039192|NCT01249027|OG000|Outcome|Observational|"Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).~XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study."
11039193|NCT01249027|EG000|Reported Event|Observational|"Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).~XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study."
11039194|NCT01249092|BG000|Baseline|Pentoxifylline 400 mg/d|All patients received same intervention.
11039195|NCT01249092|FG000|Participant Flow|Pentoxifylline 400 mg/d|All patients received same intervention.
11039196|NCT01249092|OG000|Outcome|Change in Alkaline Phosphatase After Pentoxifylline Therapy|
11039197|NCT01249092|OG000|Outcome|Change in Serum TIMP-1 (Tissue Inhibitor metalloproteinase1)|
11039198|NCT01249092|OG000|Outcome|Pentoxifylline 400 mg/d|Descriptive information only of small open label pilot. Small patient number not amenable for any valid statistical comparisons regarding side effects. All patients received same intervention. No SAEs occurred.
11039199|NCT01249092|EG000|Reported Event|Pentoxifylline 400 mg/d|All patients received same intervention.
11039200|NCT01249118|BG000|Baseline|Entire Study Population|"Part 1: Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.~Part 2: Participants received single dose of GDC-0973 2 mg IV infusion and GDC-0973 20 mg oral capsules (four 5-mg capsules) in either of the two intervention periods. There was a washout period of minimum 10 days after each intervention period."
11039201|NCT01249118|FG000|Participant Flow|Part 1: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 milligrams (mg) intravenous (IV) infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
11039202|NCT01249118|FG001|Participant Flow|Part 2: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
11039203|NCT01249118|FG002|Participant Flow|Part 2: GDC-0973 Capsules First, Then GDC-0973 IV Infusion|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in first intervention period followed by single dose of GDC-0973 2 mg IV infusion in second intervention period. There was a washout period of minimum 10 days after each intervention period.
11039204|NCT01249118|OG000|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
11039205|NCT01249118|OG001|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
11039206|NCT01249118|OG000|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
11039207|NCT01249118|EG000|Reported Event|GDC-0973 2 mg IV|Participants received GDC-0973 2 mg IV infusion in either intervention period in part 1 and part 2 of the study.
11039208|NCT01249118|EG001|Reported Event|GDC-0973 20 mg Oral|Participants received GDC-0973 20 mg oral capsules (four 5-mg capsule) in either intervention period in part 1 and part 2 of the study.
11039209|NCT01249131|BG000|Baseline|Entire Study Population|All participants randomized to any treatment.
11039210|NCT01249131|FG000|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A: One 20-milligram (mg) tablet of cobimetinib administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period was a minimum of 10 days.
11226149|NCT02372006|EG000|Reported Event|Dose Finding - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11039211|NCT01249131|FG001|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
11039212|NCT01249131|FG002|Participant Flow|Treatment B First, Then Treatment A, Followed by Treatment C|Treatment B first, then Treatment A, followed by Treatment C Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period.
11039213|NCT01249131|FG003|Participant Flow|Treatment B First, Then Treatment C, Followed by Treatment A|Treatment B first, then Treatment C, followed by Treatment A Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
11039214|NCT01249131|FG004|Participant Flow|Treatment C First, Then Treatment A, Followed by Treatment B|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
11039215|NCT01249131|FG005|Participant Flow|Treatment C First, Then Treatment B, Followed by Treatment A|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
11039216|NCT01249131|OG000|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
11039217|NCT01249131|OG001|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
11039218|NCT01249131|OG002|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
11039219|NCT01249131|EG000|Reported Event|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
11039220|NCT01249131|EG001|Reported Event|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
11039221|NCT01249131|EG002|Reported Event|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
11039222|NCT01249261|BG000|Baseline|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
11039223|NCT01249261|BG001|Baseline|Risedronate|Risedronate 5mg years 1-7, no drug year 8
11039224|NCT01249261|BG002|Baseline|Total|Total of all reporting groups
11039225|NCT01249261|FG000|Participant Flow|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
11039226|NCT01249261|FG001|Participant Flow|Risedronate|Risedronate 5mg years 1-7, no drug year 8
11039227|NCT01249261|OG000|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
11039228|NCT01249261|OG001|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
11039229|NCT01249261|EG000|Reported Event|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
11039230|NCT01249261|EG001|Reported Event|Risedronate|Risedronate 5mg years 1-7, no drug year 8
11039231|NCT01249274|BG000|Baseline|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
11039232|NCT01249274|BG001|Baseline|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
11039233|NCT01249274|BG002|Baseline|Total|Total of all reporting groups
11039234|NCT01249274|FG000|Participant Flow|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
11039235|NCT01249274|FG001|Participant Flow|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
11039236|NCT01249274|OG000|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
11039237|NCT01249274|OG001|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
11039238|NCT01249274|OG000|Outcome|Placebo|Placebo: Matched placebo pills to be taken twice daily
11039239|NCT01249274|OG001|Outcome|Progesterone|Progesterone: 100mgs progesterone twice daily
11039240|NCT01249274|EG000|Reported Event|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
11039241|NCT01249274|EG001|Reported Event|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
11039242|NCT01249365|BG000|Baseline|HPV Vaccine|Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
11039243|NCT01249365|FG000|Participant Flow|HPV Vaccine|Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
11039244|NCT01249365|OG000|Outcome|HPV Vaccine|Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
11039245|NCT01249365|EG000|Reported Event|HPV Vaccine|Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
11039246|NCT01249404|BG000|Baseline|Dysport® 1000 U|Subjects received i.m.injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039247|NCT01249404|BG001|Baseline|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039248|NCT01249404|BG002|Baseline|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
11039249|NCT01249404|BG003|Baseline|Total Title|
11039250|NCT01249404|FG000|Participant Flow|Dysport® 1000 U|Subjects received intramuscular (i.m.) injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039251|NCT01249404|FG001|Participant Flow|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039252|NCT01249404|FG002|Participant Flow|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
11039253|NCT01249404|OG000|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039254|NCT01249404|OG001|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039255|NCT01249404|OG002|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
11039256|NCT01249404|EG000|Reported Event|Dysport® 1000 U|Subjects received intramuscular (i.m.) injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039257|NCT01249404|EG001|Reported Event|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039258|NCT01249404|EG002|Reported Event|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
11039259|NCT01249417|BG000|Baseline|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039260|NCT01249417|BG001|Baseline|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039261|NCT01249417|BG002|Baseline|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039262|NCT01249417|BG003|Baseline|Total|Total of all reporting groups
11039263|NCT01249417|FG000|Participant Flow|Dysport 10 U/Kg|"10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.~Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
11039264|NCT01249417|FG001|Participant Flow|Dysport 15 U/Kg|"15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.~Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
11039265|NCT01249417|FG002|Participant Flow|Placebo|"Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.~Placebo: I.M. injection on day 1 of a single treatment cycle."
11039266|NCT01249417|OG000|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039267|NCT01249417|OG001|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039268|NCT01249417|OG002|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039269|NCT01249417|EG000|Reported Event|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039270|NCT01249417|EG001|Reported Event|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039271|NCT01249417|EG002|Reported Event|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
11039272|NCT01249625|BG000|Baseline|N95 Respirator|"The investigators are comparing the selected N95 respirators against the selected medical mask.~N95 Respirator: Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period."
11039273|NCT01249625|BG001|Baseline|Medical/Surgical Mask|"The investigators are comparing the selected medical/surgical mask against the N95 respirator.~Medical/surgical mask: Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period."
11039274|NCT01249625|BG002|Baseline|Total|Total of all reporting groups
11039275|NCT01249625|FG000|Participant Flow|N95 Respirator|"The investigators are comparing the selected N95 respirators against the selected medical mask.~N95 Respirator: Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period."
11039276|NCT01249625|FG001|Participant Flow|Medical/Surgical Mask|"The investigators are comparing the selected medical/surgical mask against the N95 respirator.~Medical/surgical mask: Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period."
11039277|NCT01249625|OG000|Outcome|N95 Respirator|"The investigators are comparing the selected N95 respirators against the selected medical mask.~N95 Respirator: Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period."
11039278|NCT01249625|OG001|Outcome|Medical/Surgical Mask|"The investigators are comparing the selected medical/surgical mask against the N95 respirator.~Medical/surgical mask: Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period."
11039279|NCT01249625|EG000|Reported Event|N95 Respirator|"The investigators are comparing specific N95 respirator against specific medical masks.~Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period."
11039280|NCT01249625|EG001|Reported Event|Medical/Surgical Mask|"The investigators are comparing medical/surgical masks against the N95 respirator.~Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period."
11039281|NCT01249651|BG000|Baseline|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
11039282|NCT01249651|FG000|Participant Flow|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
11039283|NCT01249651|OG000|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
11039284|NCT01249651|EG000|Reported Event|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
11039285|NCT01249664|BG000|Baseline|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
11039286|NCT01249664|BG001|Baseline|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
11039287|NCT01249664|BG002|Baseline|Total|Total of all reporting groups
11039288|NCT01249664|FG000|Participant Flow|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
11039289|NCT01249664|FG001|Participant Flow|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
11039290|NCT01249664|OG000|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
11039291|NCT01249664|OG001|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
11039292|NCT01249664|EG000|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg single dose of IAI at baseline (Week 20). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 20 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed until week 24. Participants in the safety population were at risk.
11039293|NCT01249664|EG001|Reported Event|Sham Treatment (Until Week 20)|Participants received a sham injection every 4 weeks from week 0 through week 20. Participants were observed until week 24. Participants in the safety population were at risk.
11039294|NCT01249664|EG002|Reported Event|Aflibercept Injection (Until Week 44)|Participants who continued the study drug until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed from week 24 until week 48. Participants in the safety population were at risk.
11039295|NCT01249664|EG003|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 44)|Participants who continued the sham treatment until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment were not met, participant received a sham injection. Participants were observed from Week 24 until Week 48. Participants in the safety population were at risk.
11039296|NCT01249833|BG000|Baseline|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
11039297|NCT01249833|BG001|Baseline|Standard of Care Alone|Standard of care for influenza
11039298|NCT01249833|BG002|Baseline|Total|Total of all reporting groups
11348905|NCT04138810|EG001|Reported Event|Office Post-operative Visits|"As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The traditional follow up group will receive a telephone call from the office nurse as is current standard of care. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.~Survey: Measure of satisfaction regarding post-op visit."
10848907|NCT00292370|EG002|Reported Event|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Quetiapine: Double-blind quetiapine taken with OL paroxetine"
11039299|NCT01249833|FG000|Participant Flow|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
11039300|NCT01249833|FG001|Participant Flow|Standard of Care Alone|Standard of care for influenza
11039301|NCT01249833|OG000|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
11039302|NCT01249833|OG001|Outcome|Standard of Care Alone|Standard of care for influenza
11039303|NCT01249833|EG000|Reported Event|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
11039304|NCT01249833|EG001|Reported Event|Standard of Care Alone|Standard of care for influenza
11039305|NCT01249872|BG000|Baseline|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039306|NCT01249872|BG001|Baseline|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intraoperatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039307|NCT01249872|BG002|Baseline|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intraoperatively (45 min before the estimated end of the surgery) an epidural bolus dose 2 mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039308|NCT01249872|BG003|Baseline|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 ml of normal saline. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039309|NCT01249872|BG004|Baseline|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039310|NCT01249872|BG005|Baseline|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039311|NCT01249872|BG006|Baseline|Total|Total of all reporting groups
11039312|NCT01249872|FG000|Participant Flow|GROUP A : 0 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039313|NCT01249872|FG001|Participant Flow|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039314|NCT01249872|FG002|Participant Flow|GROUP C : 2 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039315|NCT01249872|FG003|Participant Flow|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039316|NCT01249872|FG004|Participant Flow|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11348906|NCT04131556|BG000|Baseline|Maribavir|Participants received 200 milligrams (mg) of maribavir tablet orally (Treatment A) or 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Treatment B) or maribavir 200 mg powder for oral suspension with 36.1% drug loading (Treatment C) on Day 1 or Day 4 or Day 7 in different sequences of ABC, BCA, CAB, CBA, ACB, and BAC.
10848908|NCT00292461|BG000|Baseline|Zonegran|once or twice daily orally for 16 weeks
10848909|NCT00292461|BG001|Baseline|Lamotrigine|once daily orally for 16 weeks
11039317|NCT01249872|FG005|Participant Flow|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039318|NCT01249872|OG000|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039319|NCT01249872|OG001|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039320|NCT01249872|OG002|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039321|NCT01249872|OG003|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039322|NCT01249872|OG004|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039323|NCT01249872|OG005|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039324|NCT01249872|OG000|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039325|NCT01249872|OG001|Outcome|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039326|NCT01249872|OG002|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039327|NCT01249872|OG003|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039328|NCT01249872|OG001|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039329|NCT01249872|OG003|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039330|NCT01249872|OG005|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039331|NCT01249872|OG004|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
10848910|NCT00292461|BG002|Baseline|Total|Total of all reporting groups
10848911|NCT00292461|FG000|Participant Flow|Zonegran|once or twice daily orally for 16 weeks
10848912|NCT00292461|FG001|Participant Flow|Lamotrigine|once daily orally for 16 weeks
11039332|NCT01249872|EG000|Reported Event|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039333|NCT01249872|EG001|Reported Event|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039334|NCT01249872|EG002|Reported Event|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039335|NCT01249872|EG003|Reported Event|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039336|NCT01249872|EG004|Reported Event|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039337|NCT01249872|EG005|Reported Event|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
11039338|NCT01250002|BG000|Baseline|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
11039339|NCT01250002|BG001|Baseline|Placebo|Group B (control group) will receive the same volume of saline infusion.
11039340|NCT01250002|BG002|Baseline|Total|Total of all reporting groups
11039341|NCT01250002|FG000|Participant Flow|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
11039342|NCT01250002|FG001|Participant Flow|Placebo|Group B (control group) will receive the same volume of saline infusion.
11039343|NCT01250002|OG000|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
11039344|NCT01250002|OG001|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
11039345|NCT01250002|EG000|Reported Event|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
11039346|NCT01250002|EG001|Reported Event|Placebo|Group B (control group) will receive the same volume of saline infusion.
11039347|NCT01250054|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
11039348|NCT01250054|FG000|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
11039349|NCT01250054|FG001|Participant Flow|Comfilcon A /Lotrafilcon B|Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
11039350|NCT01250054|OG000|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
11039351|NCT01250054|OG001|Outcome|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
11039352|NCT01250054|EG000|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
11039353|NCT01250054|EG001|Reported Event|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
11039354|NCT01250119|BG000|Baseline|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
11039355|NCT01250119|FG000|Participant Flow|Non-small-cell Lung Cancer (NSCLC) Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
11039356|NCT01250119|FG001|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent.
11039357|NCT01250119|OG000|Outcome|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
11039358|NCT01250119|OG000|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
11039359|NCT01250119|OG000|Outcome|EGFR Positive|All participants who tested positive for EGFR mutations were included in this group.
11039360|NCT01250119|OG001|Outcome|EGFR Negative|All participants who tested negative for EGFR mutations were included in this group.
11039361|NCT01250119|EG000|Reported Event|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
11039362|NCT01250145|BG000|Baseline|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
11039363|NCT01250145|BG001|Baseline|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
11039364|NCT01250145|BG002|Baseline|Total|Total of all reporting groups
11039365|NCT01250145|FG000|Participant Flow|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
11039366|NCT01250145|FG001|Participant Flow|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
11039367|NCT01250145|OG000|Outcome|Part A: Active Patch - Prior to Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
11039368|NCT01250145|OG001|Outcome|Part A: Active Patch - 1 Hour Post Patch Removal|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
11039369|NCT01250145|OG002|Outcome|Part A: Active Patch - 24 Hours Post Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
11039370|NCT01250145|OG003|Outcome|Part A: Placebo Patch - Prior to Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
11039371|NCT01250145|OG004|Outcome|Part A: Placebo Patch - 1 Hour Post Patch Removal|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
11039372|NCT01250145|OG005|Outcome|Part A: Placebo Patch - 24 Hours Post Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
11039373|NCT01250145|OG000|Outcome|Active Patch|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
11039374|NCT01250145|OG001|Outcome|Placebo Patch|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
11039375|NCT01250145|OG000|Outcome|Part B: Active Patch - Prior to Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
11039376|NCT01250145|OG001|Outcome|Part B: Active Patch - 1 Hour Post Patch Removal|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
11039377|NCT01250145|OG002|Outcome|Part B: Active Patch - 24 Hours Post Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
11039378|NCT01250145|OG003|Outcome|Part B: Placebo Patch - Prior to Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
11039379|NCT01250145|OG004|Outcome|Part B: Placebo Patch - 1 Hour Post Patch Removal|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
11039380|NCT01250145|OG005|Outcome|Part B: Placebo Patch - 24 Hours Post Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
11039381|NCT01250145|OG000|Outcome|Active Patch|"Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
11039382|NCT01250145|OG001|Outcome|Placebo Patch|"Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.~Rest phase: 2 weeks with no patch application~Challenge phase: placebo patch given once for at least 6 hours"
11039383|NCT01250145|EG000|Reported Event|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
11039384|NCT01250145|EG001|Reported Event|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
11039385|NCT01250171|BG000|Baseline|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
11039386|NCT01250171|BG001|Baseline|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
11039387|NCT01250171|BG002|Baseline|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
11039388|NCT01250171|BG003|Baseline|Total|Total of all reporting groups
11039389|NCT01250171|FG000|Participant Flow|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
11039390|NCT01250171|FG001|Participant Flow|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
11039391|NCT01250171|FG002|Participant Flow|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
11039392|NCT01250171|OG000|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
11039393|NCT01250171|OG001|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
11039394|NCT01250171|OG002|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
11039395|NCT01250171|EG000|Reported Event|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
11039396|NCT01250171|EG001|Reported Event|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
11039397|NCT01250171|EG002|Reported Event|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
11039398|NCT01250184|BG000|Baseline|Blocking the MTP Plus Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
11039399|NCT01250184|BG001|Baseline|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
11039400|NCT01250184|BG002|Baseline|Blocking the MTP|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
11039401|NCT01250184|BG003|Baseline|Total|Total of all reporting groups
11039402|NCT01250184|FG000|Participant Flow|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
11039403|NCT01250184|FG001|Participant Flow|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
11039404|NCT01250184|FG002|Participant Flow|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
11039405|NCT01250184|OG000|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
11039406|NCT01250184|OG001|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
11039407|NCT01250184|OG002|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
11039408|NCT01250184|EG000|Reported Event|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
11039409|NCT01250184|EG001|Reported Event|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
11039410|NCT01250184|EG002|Reported Event|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
11039411|NCT01250210|BG000|Baseline|AG200LE Transdermal Contraceptive Delivery System|a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).
11039412|NCT01250210|BG001|Baseline|AG200 Transdermal Contraceptive Delivery System|a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).
11039413|NCT01250210|BG002|Baseline|AG200-15 Transdermal Contraceptive System|a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).
11039414|NCT01250210|BG003|Baseline|Total|Total of all reporting groups
11039415|NCT01250210|FG000|Participant Flow|AG200LE Transdermal Contraceptive Delivery System|a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).
11039416|NCT01250210|FG001|Participant Flow|AG200 Transdermal Contraceptive Delivery System|a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).
11039417|NCT01250210|FG002|Participant Flow|AG200-15 Transdermal Contraceptive System|a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).
11039418|NCT01250210|OG000|Outcome|AG200LE|a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).
11039419|NCT01250210|OG001|Outcome|AG200|a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).
11039420|NCT01250210|OG002|Outcome|AG200-15|a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).
11039421|NCT01250210|EG000|Reported Event|AG200LE|a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).
11039422|NCT01250210|EG001|Reported Event|AG200|a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).
11039423|NCT01250210|EG002|Reported Event|AG200-15|a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).
11039424|NCT01250379|BG000|Baseline|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
11039425|NCT01250379|BG001|Baseline|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
11039426|NCT01250379|BG002|Baseline|Total|Total of all reporting groups
11039427|NCT01250379|FG000|Participant Flow|Chemotherapy (CT) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
11039428|NCT01250379|FG001|Participant Flow|Chemotherapy Plus Bevacizumab (CT+BV) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
11039429|NCT01250379|OG000|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
11039430|NCT01250379|OG001|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
11039431|NCT01250379|EG000|Reported Event|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
11039432|NCT01250379|EG001|Reported Event|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
11039433|NCT01250418|BG000|Baseline|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.~Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
11039434|NCT01250418|BG001|Baseline|No Ketamine|No ketamine added to anesthesia regimen
11039435|NCT01250418|BG002|Baseline|Total|Total of all reporting groups
11039436|NCT01250418|FG000|Participant Flow|Ketamine Group|ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
11039437|NCT01250418|FG001|Participant Flow|No Ketamine|No ketamine added to anesthesia regimen
10848913|NCT00292461|OG000|Outcome|Zonegran|once or twice daily orally for 16 weeks
11039438|NCT01250418|OG000|Outcome|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.~Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
11039439|NCT01250418|OG001|Outcome|No Ketamine|No ketamine added to anesthesia regimen
11039440|NCT01250418|EG000|Reported Event|No Ketamine Added to Anesthesia Regimen|No ketamine added to the patients anesthesia regimen
11039441|NCT01250418|EG001|Reported Event|Ketamine Group|Ketamine group: Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
11039442|NCT01250509|BG000|Baseline|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
11039443|NCT01250509|BG001|Baseline|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
11039444|NCT01250509|BG002|Baseline|Total|Total of all reporting groups
11039445|NCT01250509|FG000|Participant Flow|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
11039446|NCT01250509|FG001|Participant Flow|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
11039447|NCT01250509|OG000|Outcome|CALMM|
11039448|NCT01250509|OG001|Outcome|Waitlist|
11039449|NCT01250509|OG000|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
11039450|NCT01250509|OG001|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
11039451|NCT01250509|EG000|Reported Event|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
11039452|NCT01250509|EG001|Reported Event|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
11039453|NCT01250717|BG000|Baseline|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
11039454|NCT01250717|FG000|Participant Flow|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
11039455|NCT01250717|OG000|Outcome|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
11039456|NCT01250717|EG000|Reported Event|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
11039457|NCT01250730|BG000|Baseline|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
11039458|NCT01250730|BG001|Baseline|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
11039459|NCT01250730|BG002|Baseline|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
11039460|NCT01250730|BG003|Baseline|Total|Total of all reporting groups
11039461|NCT01250730|FG000|Participant Flow|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
11039462|NCT01250730|FG001|Participant Flow|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
11039463|NCT01250730|FG002|Participant Flow|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
11039464|NCT01250730|OG000|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
11039465|NCT01250730|OG001|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
11039466|NCT01250730|OG002|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
11039467|NCT01250730|EG000|Reported Event|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
11039468|NCT01250730|EG001|Reported Event|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
11039469|NCT01250730|EG002|Reported Event|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
11066521|NCT01392703|FG000|Participant Flow|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
11039470|NCT01250756|BG000|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
11039471|NCT01250756|BG001|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
11039472|NCT01250756|BG002|Baseline|Total|Total of all reporting groups
11039473|NCT01250756|FG000|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
11039474|NCT01250756|FG001|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
11039475|NCT01250756|OG000|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
11039476|NCT01250756|OG001|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
11039477|NCT01250756|OG000|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
11039478|NCT01250756|EG000|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
11039479|NCT01250756|EG001|Reported Event|DTaP (Catch-up 7vPnC)- Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
11039480|NCT01250756|EG002|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
11039481|NCT01250756|EG003|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
11039482|NCT01250756|EG004|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
11039483|NCT01250756|EG005|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
11039484|NCT01250756|EG006|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
11039485|NCT01250769|BG000|Baseline|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
11039486|NCT01250769|BG001|Baseline|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
11039487|NCT01250769|BG002|Baseline|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
11039488|NCT01250769|BG003|Baseline|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
10848914|NCT00292461|OG001|Outcome|Lamotrigine|once daily orally for 16 weeks
11039489|NCT01250769|BG004|Baseline|Total|Total of all reporting groups
11039490|NCT01250769|FG000|Participant Flow|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
11039491|NCT01250769|FG001|Participant Flow|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
11039492|NCT01250769|FG002|Participant Flow|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
11039493|NCT01250769|FG003|Participant Flow|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
11039494|NCT01250769|OG000|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
11039495|NCT01250769|OG001|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
11039496|NCT01250769|OG002|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
11039497|NCT01250769|OG003|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
11039498|NCT01250769|EG000|Reported Event|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
11039499|NCT01250769|EG001|Reported Event|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
11039500|NCT01250769|EG002|Reported Event|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
11039501|NCT01250769|EG003|Reported Event|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
11039502|NCT01250834|BG000|Baseline|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.~Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
11039503|NCT01250834|FG000|Participant Flow|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.~Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
11039504|NCT01250834|OG000|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
11039505|NCT01250834|OG001|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
11039506|NCT01250834|EG000|Reported Event|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
11039507|NCT01250834|EG001|Reported Event|1.5 mg LY2189265|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3.
11039508|NCT01250834|EG002|Reported Event|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2.
11066522|NCT01392703|FG001|Participant Flow|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
11066523|NCT01392703|FG002|Participant Flow|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
11066524|NCT01392703|OG000|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
11066525|NCT01392703|OG001|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
11066526|NCT01392703|OG002|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
11066527|NCT01392703|OG001|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period..
11066528|NCT01392703|OG000|Outcome|All Treated|
11066529|NCT01392703|EG000|Reported Event|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
11066530|NCT01392703|EG001|Reported Event|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
11066531|NCT01392703|EG002|Reported Event|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
11039509|NCT01250873|BG000|Baseline|LY2216684/Sertraline/LY2216684 + Sertraline|Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
11039510|NCT01250873|FG000|Participant Flow|LY2216684/Sertraline/LY2216684 + Sertraline|Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
11039511|NCT01250873|OG000|Outcome|LY2216684/Sertraline/LY2216684 + Sertraline|Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
11039512|NCT01250873|EG000|Reported Event|LY2216684|Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
11039513|NCT01250873|EG001|Reported Event|Sertraline|Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10.
11039514|NCT01250873|EG002|Reported Event|LY2216684 + Sertraline|Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
11039515|NCT01250899|BG000|Baseline|Vitamin D Sufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
11039516|NCT01250899|BG001|Baseline|Vitamin D Insufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks.
11039517|NCT01250899|BG002|Baseline|Total|Total of all reporting groups
11039518|NCT01250899|FG000|Participant Flow|Vitamin D Sufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
11039519|NCT01250899|FG001|Participant Flow|Vitamin D Insufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
11039520|NCT01250899|OG000|Outcome|Vitamin D Insufficient|Baseline 25(OH)D <30 ng/mL received 12 weeks of oral vitamin D supplementation. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
11039521|NCT01250899|EG000|Reported Event|Vitamin D Insufficient|25(OH)D <30 mg/mL at study entry (i.e. group of patients receiving vitamin D supplementation).
11039522|NCT01250925|BG000|Baseline|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039523|NCT01250925|BG001|Baseline|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039524|NCT01250925|BG002|Baseline|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039525|NCT01250925|BG003|Baseline|Total|Total of all reporting groups
11039526|NCT01250925|FG000|Participant Flow|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039527|NCT01250925|FG001|Participant Flow|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039528|NCT01250925|FG002|Participant Flow|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039529|NCT01250925|OG000|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039530|NCT01250925|OG001|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039531|NCT01250925|OG002|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039532|NCT01250925|EG000|Reported Event|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039533|NCT01250925|EG001|Reported Event|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039534|NCT01250925|EG002|Reported Event|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
11039535|NCT01250977|BG000|Baseline|Placebo|Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.
11039536|NCT01250977|BG001|Baseline|Donepezil|Participants are instructed to take one 5mg pill (donepezil HCL [Aricept®]) every night before going to bed with a glass of water for 28 days.
11039537|NCT01250977|BG002|Baseline|Total|Total of all reporting groups
11039538|NCT01250977|FG000|Participant Flow|Placebo|Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.
11039539|NCT01250977|FG001|Participant Flow|Donepezil|Participants are instructed to take one 5mg pill (donepezil HCL [Aricept®]) every night before going to bed with a glass of water for 28 days.
11039540|NCT01250977|OG000|Outcome|Placebo|Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.
11039541|NCT01250977|OG001|Outcome|Donepezil|Participants are instructed to take one 5mg pill (donepezil HCL [Aricept®]) every night before going to bed with a glass of water for 28 days.
11039542|NCT01250977|EG000|Reported Event|Placebo|Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.
11039543|NCT01250977|EG001|Reported Event|Donepezil|Participants are instructed to take one 5mg pill (donepezil HCL [Aricept®]) every night before going to bed with a glass of water for 28 days.
11039544|NCT01250990|BG000|Baseline|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
11039545|NCT01250990|BG001|Baseline|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
11039546|NCT01250990|BG002|Baseline|Total|Total of all reporting groups
11039547|NCT01250990|FG000|Participant Flow|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
11039548|NCT01250990|FG001|Participant Flow|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
11039549|NCT01250990|OG000|Outcome|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
11039550|NCT01250990|OG001|Outcome|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
11039551|NCT01250990|EG000|Reported Event|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
11039552|NCT01250990|EG001|Reported Event|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
11039553|NCT01251042|BG000|Baseline|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
11039554|NCT01251042|BG001|Baseline|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
11039555|NCT01251042|BG002|Baseline|Total|Total of all reporting groups
11039556|NCT01251042|FG000|Participant Flow|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
11039557|NCT01251042|FG001|Participant Flow|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
11039558|NCT01251042|OG000|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
11039559|NCT01251042|OG001|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
11039560|NCT01251042|EG000|Reported Event|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
11039561|NCT01251042|EG001|Reported Event|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
11039562|NCT01251146|BG000|Baseline|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
11039563|NCT01251146|BG001|Baseline|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
11039564|NCT01251146|BG002|Baseline|Total|Total of all reporting groups
11039565|NCT01251146|FG000|Participant Flow|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
11066532|NCT01392742|BG000|Baseline|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion.
10848915|NCT00292461|EG000|Reported Event|Zonegran|once or twice daily orally for 16 weeks
11039566|NCT01251146|FG001|Participant Flow|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
11039567|NCT01251146|OG000|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
11039568|NCT01251146|OG001|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
11039569|NCT01251146|EG000|Reported Event|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
11039570|NCT01251146|EG001|Reported Event|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
11039571|NCT01251276|BG000|Baseline|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
11039572|NCT01251276|BG001|Baseline|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
11039573|NCT01251276|BG002|Baseline|Total|Total of all reporting groups
11039574|NCT01251276|FG000|Participant Flow|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
11039575|NCT01251276|FG001|Participant Flow|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
11039576|NCT01251276|OG000|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
11039577|NCT01251276|OG001|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
11039578|NCT01251276|EG000|Reported Event|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
11039579|NCT01251276|EG001|Reported Event|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
11039580|NCT01251315|BG000|Baseline|Placebo-A|low dose oral x1
11039581|NCT01251315|BG001|Baseline|N Acetyl Cysteine-A|N Acetyl cysteine low dose group (600mg oral X1)
11039582|NCT01251315|BG002|Baseline|Proimmune 200-A|Proimmune 200 low dose group (3000mg oral X 1)
11039583|NCT01251315|BG003|Baseline|Placebo-B|High dose oral X1
11039584|NCT01251315|BG004|Baseline|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group ( 1200mg oral X1)
10848916|NCT00292461|EG001|Reported Event|Lamotrigine|once daily orally for 16 weeks
11039585|NCT01251315|BG005|Baseline|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
11039586|NCT01251315|BG006|Baseline|Total|Total of all reporting groups
11039587|NCT01251315|FG000|Participant Flow|Placebo Low Dose Group, Given Oral as a Single Dose|Placebo low dose group, given oral as a single dose
11039588|NCT01251315|FG001|Participant Flow|N Acetyl Cysteine (Low Dose, 600mg Oral as a Single Dose)|N Acetyl cysteine (low dose, 600mg oral as a single dose)
11039589|NCT01251315|FG002|Participant Flow|Proimmune 200 (Low Dose, 3000 mg Oral as a Single Dose)|Proimmune 200 (low dose, 3000 mg oral as a single dose)
11039590|NCT01251315|FG003|Participant Flow|Placebo High Dose Group, Given Oral as a Single Dose|Placebo high dose group, given oral as a single dose
11039591|NCT01251315|FG004|Participant Flow|N Acetyl Cysteine (High Dose, 1200 mg Oral as a Single Dose)|N Acetyl cysteine (high dose 1200 mg oral as a single dose)
11039592|NCT01251315|FG005|Participant Flow|Proimmune 200 (High Dose, 6000 mg Oral as a Single Dose)|Proimmune 200 (high dose, 6000 mg oral as a single dose)
10848917|NCT00292591|BG000|Baseline|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11039593|NCT01251315|OG000|Outcome|Placebo-A|Placebo low dose group
11039594|NCT01251315|OG001|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group ( 600mg oral x1)
11039595|NCT01251315|OG002|Outcome|Proimmune 200-A|Proimmune 200 low dose group ( 3000mg oral x1)
11039596|NCT01251315|OG003|Outcome|Placebo-B|Placebo High dose group
11039597|NCT01251315|OG004|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group (1200 mg oral x1)
11039598|NCT01251315|OG005|Outcome|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
11039599|NCT01251315|OG001|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
11039600|NCT01251315|OG002|Outcome|Proimmune 200-A|Proimmune 200 low dose group
11039601|NCT01251315|OG004|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
11039602|NCT01251315|OG005|Outcome|Proimmune 200-B|Proimmune 200 High dose group
11039603|NCT01251315|EG000|Reported Event|Placebo-A|low dose group
11039604|NCT01251315|EG001|Reported Event|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
11039605|NCT01251315|EG002|Reported Event|Proimmune 200-A|Proimmune 200 low dose group
11039606|NCT01251315|EG003|Reported Event|Placebo-B|High dose group
11039607|NCT01251315|EG004|Reported Event|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
11039608|NCT01251315|EG005|Reported Event|Proimmune 200-B|Proimmune 200 High dose group
11039609|NCT01251354|BG000|Baseline|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
11039610|NCT01251354|FG000|Participant Flow|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
11039611|NCT01251354|OG000|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
11039612|NCT01251354|EG000|Reported Event|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
11039613|NCT01251367|BG000|Baseline|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039614|NCT01251367|FG000|Participant Flow|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 Units [U] or 1000 U) by intramuscular (i.m.) injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039615|NCT01251367|OG000|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11066533|NCT01392742|FG000|Participant Flow|Hepatitis C Virus (HCV) Infected Participants|Participants who were infected by HCV and receiving pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 micrograms per week (µg/week) subcutaneously, plus ribavirin tablets 1000 milligrams (mg) (those weighing less than [<] 75 kilograms [kg]) or 1200 mg (those weighing greater than [>] 75 kg) orally; were observed for approximately up to 24 weeks after end of treatment (EOT). Dose change was as per investigators' discretion.
11039616|NCT01251367|EG000|Reported Event|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
11039617|NCT01251380|BG000|Baseline|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
11039618|NCT01251380|FG000|Participant Flow|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
11039619|NCT01251380|OG000|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs.
11039620|NCT01251380|OG000|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
11039621|NCT01251380|OG000|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5U/kg to 20U/kg for one leg and 10U/kg to 30U/kg for both legs
11039622|NCT01251380|OG000|Outcome|Dysport Treatment Cycle 1|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
11039623|NCT01251380|OG001|Outcome|Dysport Treatment Cycle 2|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
11039624|NCT01251380|OG002|Outcome|Dysport Treatment Cycle 3|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
11039625|NCT01251380|EG000|Reported Event|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs.
11039626|NCT01251393|BG000|Baseline|Biperiden|55 participants took biperidene for 2 months.
11039627|NCT01251393|BG001|Baseline|Placebo|55 participants took placebo for 2 months.
11039628|NCT01251393|BG002|Baseline|Total|Total of all reporting groups
11039629|NCT01251393|FG000|Participant Flow|Biperiden|"Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.~Biperiden: Thirty volunteers will take three pills of Biperiden (6mg/day) during two months."
11039630|NCT01251393|FG001|Participant Flow|Placebo|"Thirty volunteers will take three pills of Placebo (6mg/day) during two months.~Placebo: Thirty volunteers will take three pills of Placebo (6mg/day) during two months."
11039631|NCT01251393|OG000|Outcome|Biperiden|"Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.~Biperiden: Thirty volunteers will take three pills of Biperiden (6mg/day) during two months."
11039632|NCT01251393|OG001|Outcome|Placebo|"Thirty volunteers will take three pills of Placebo (6mg/day) during two months.~Placebo: Thirty volunteers will take three pills of Placebo (6mg/day) during two months."
11039633|NCT01251393|EG000|Reported Event|Placebo|No adverse event
11039634|NCT01251393|EG001|Reported Event|Biperiden|No adverse event
11039635|NCT01251536|BG000|Baseline|Arm A - Dose Escalation of Cetuximab|"Patients with no cetuximab-related skin toxicity or other significant toxicity after first 3 weeks of treatment with cetuximab standard dosing in combination with FOLFIRI, in whom cetuximab doses were increased at day 22.~Dose escalation of cetuximab: Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)~Arm allocation at day 22:~Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly"
11039636|NCT01251536|BG001|Baseline|Arm B - Standard Dose of Cetuximab|"Patients with any grade cetuximab-related skin toxicity or other significant toxicity after first 3 weeks of treatment with cetuximab standard dosing in combination with FOLFIRI, in whom cetuximab doses were maintained at standard levels at day 22.~Standard first line treatment with cetuximab + Folfiri: Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)~Arm allocation at day 22:~Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly."
11039637|NCT01251536|BG002|Baseline|Not Allocated|Patients unable to continue treatment with cetuximab and FOLFIRI at standard or reduced doses, requiring discontinuation before arm allocation at day 22.
11039638|NCT01251536|BG003|Baseline|Total|Total of all reporting groups
11039639|NCT01251536|FG000|Participant Flow|Arm A - Dose Escalation of Cetuximab|"Patients with no cetuximab-related skin toxicity or other significant toxicity after first 3 weeks of treatment with cetuximab standard dosing in combination with FOLFIRI, in whom cetuximab doses were increased at day 22.~Dose escalation of cetuximab: Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)~Arm allocation at day 22:~Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly"
11039640|NCT01251536|FG001|Participant Flow|Arm B - Standard Dose of Cetuximab|"Patients with any grade cetuximab-related skin toxicity or other significant toxicity after first 3 weeks of treatment with cetuximab standard dosing in combination with FOLFIRI, in whom cetuximab doses were maintained at standard levels at day 22.~Standard first line treatment with cetuximab + Folfiri: Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)~Arm allocation at day 22:~Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly."
11039641|NCT01251536|FG002|Participant Flow|Not Allocated|Patients unable to continue treatment with cetuximab and FOLFIRI at standard or reduced doses, requiring discontinuation before arm allocation at day 22.
11039642|NCT01251536|OG000|Outcome|Arm A - Dose Escalation of Cetuximab|"Patients with no cetuximab-related skin toxicity or other significant toxicity after first 3 weeks of treatment with cetuximab standard dosing in combination with FOLFIRI, in whom cetuximab doses were increased at day 22.~Dose escalation of cetuximab: Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)~Arm allocation at day 22:~Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly"
11039643|NCT01251536|OG001|Outcome|Arm B - Standard Dose of Cetuximab|"Patients with any grade cetuximab-related skin toxicity or other significant toxicity after first 3 weeks of treatment with cetuximab standard dosing in combination with FOLFIRI, in whom cetuximab doses were maintained at standard levels at day 22.~Standard first line treatment with cetuximab + Folfiri: Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)~Arm allocation at day 22:~Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly."
11039644|NCT01251536|OG002|Outcome|Not Allocated|Patients unable to continue treatment with cetuximab and FOLFIRI at standard or reduced doses, requiring discontinuation before arm allocation at day 22.
11039645|NCT01251536|OG003|Outcome|ITT / Safety Set|All patients for whom there was evidence they were administered any dose of cetuximab or FOLFIRI on study. For this study, the safety set includes all patients and is identical to the intention-to-treat (ITT) set.
11039646|NCT01251536|OG002|Outcome|ITT / Safety Set|All patients for whom there was evidence they were administered any dose of cetuximab or FOLFIRI on study. For this study, the safety set includes all patients and is identical to the intention-to-treat (ITT) set.
11039647|NCT01251536|EG000|Reported Event|Arm A - Dose Escalation of Cetuximab|"Patients with no cetuximab-related skin toxicity or other significant toxicity after first 3 weeks of treatment with cetuximab standard dosing in combination with FOLFIRI, in whom cetuximab doses were increased at day 22.~Dose escalation of cetuximab: Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)~Arm allocation at day 22:~Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly"
11039648|NCT01251536|EG001|Reported Event|Arm B - Standard Dose of Cetuximab|"Patients with any grade cetuximab-related skin toxicity or other significant toxicity after first 3 weeks of treatment with cetuximab standard dosing in combination with FOLFIRI, in whom cetuximab doses were maintained at standard levels at day 22.~Standard first line treatment with cetuximab + Folfiri: Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)~Arm allocation at day 22:~Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly."
11039649|NCT01251536|EG002|Reported Event|Not Allocated|Patients unable to continue treatment with cetuximab and FOLFIRI at standard or reduced doses, requiring discontinuation before arm allocation at day 22.
11039650|NCT01251575|BG000|Baseline|Treatment (Fludarabine, Transplant, Immunosuppression)|"CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation.~IMMUNOSUPPRESSION: Patients receive sirolimus PO QD on days -3 to 180 with taper to day 365; cyclosporine PO BID on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO TID on days 0-30 and then BID to day 100 with taper to day 150.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Sirolimus: Given PO~Total-Body Irradiation: Undergo total-body irradiation"
11039651|NCT01251575|FG000|Participant Flow|Treatment (Fludarabine, Transplant, Immunosuppression)|"CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation.~IMMUNOSUPPRESSION: Patients receive sirolimus PO QD on days -3 to 180 with taper to day 365; cyclosporine PO BID on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO TID on days 0-30 and then BID to day 100 with taper to day 150.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Sirolimus: Given PO~Total-Body Irradiation: Undergo total-body irradiation"
11039652|NCT01251575|OG000|Outcome|Class I Mismatch|Patients 1) mismatched at antigen level for any single class I locus (HLA-A, -B, -C) +/- an additional class mismatch at the allele level, or 2) mismatched at the allele level for any 2 class I loci.
11039653|NCT01251575|OG001|Outcome|Class II Mismatch|Patients mismatched at the antigen or allele level for class II loci HLA-DRB1 and/or DQB1. Must be matched for at least one DRB1 allele and one DQB1 allele.
11039654|NCT01251575|OG000|Outcome|Treatment (Fludarabine, Transplant, Immunosuppression)|"CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation.~IMMUNOSUPPRESSION: Patients receive sirolimus PO QD on days -3 to 180 with taper to day 365; cyclosporine PO BID on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO TID on days 0-30 and then BID to day 100 with taper to day 150.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Sirolimus: Given PO~Total-Body Irradiation: Undergo total-body irradiation"
11039655|NCT01251575|EG000|Reported Event|Treatment (Fludarabine, Transplant, Immunosuppression)|"CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation.~IMMUNOSUPPRESSION: Patients receive sirolimus PO QD on days -3 to 180 with taper to day 365; cyclosporine PO BID on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO TID on days 0-30 and then BID to day 100 with taper to day 150.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Sirolimus: Given PO~Total-Body Irradiation: Undergo total-body irradiation"
11039656|NCT01251588|BG000|Baseline|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
11039657|NCT01251588|BG001|Baseline|Microfracture|Microfracture: Arthroscopic Microfracture
11039658|NCT01251588|BG002|Baseline|Total|Total of all reporting groups
11039659|NCT01251588|FG000|Participant Flow|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
11039660|NCT01251588|FG001|Participant Flow|Microfracture|Microfracture: Arthroscopic Microfracture
11039661|NCT01251588|OG000|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
11039662|NCT01251588|OG001|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
11039663|NCT01251588|OG000|Outcome|MACI|"autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study~autologous cultured chondrocytes on porcine collagen membrane: Implantation received in the previous MACI00206 study"
11039664|NCT01251588|OG001|Outcome|Microfracture|"Microfracture treatment received in previous MACI00206 study~Microfracture: Arthroscopic Microfracture treatment received in the previous MACI00206 study"
11039665|NCT01251588|EG000|Reported Event|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
11039666|NCT01251588|EG001|Reported Event|Microfracture|Microfracture: Arthroscopic Microfracture
11039667|NCT01251614|BG000|Baseline|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
11039668|NCT01251614|BG001|Baseline|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
11039669|NCT01251614|BG002|Baseline|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
11039670|NCT01251614|BG003|Baseline|Total|Total of all reporting groups
11039671|NCT01251614|FG000|Participant Flow|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
11066534|NCT01392742|OG000|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion.
11066535|NCT01392742|EG000|Reported Event|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately 24 weeks. Dose change was as per investigators' discretion.
11039672|NCT01251614|FG001|Participant Flow|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
11039673|NCT01251614|FG002|Participant Flow|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
11039674|NCT01251614|OG000|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
11039675|NCT01251614|OG001|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
11039676|NCT01251614|OG002|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
11039677|NCT01251614|OG000|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
11039678|NCT01251614|OG001|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
11039679|NCT01251614|OG002|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
11039680|NCT01251614|EG000|Reported Event|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
11039681|NCT01251614|EG001|Reported Event|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
11039682|NCT01251614|EG002|Reported Event|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
11039683|NCT01251614|EG003|Reported Event|Period B: MTX/No Treatment|Participants initially randomized to methotrexate who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
11039684|NCT01251614|EG004|Reported Event|Period B: ADA 0.4 mg/kg/No Treatment|Participants initially randomized to adalimumab (ADA) 0.4 mg/kg who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
11039685|NCT01251614|EG005|Reported Event|Period B: ADA 0.8 mg/kg/No Treatment|Participants initially randomized to adalimumab (ADA) 0.8 mg/kg who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
11039686|NCT01251614|EG006|Reported Event|Period C: Adalimumab 0.4 mg/kg|Participants initially randomized to adalimumab 0.4 mg/kg with loss of disease control in Period B received adalimumab 0.4 mg/kg eow for up to 16 weeks in Period C.
11039687|NCT01251614|EG007|Reported Event|Period C: Adalimumab 0.8 mg/kg|Participants initially randomized to either methotrexate or adalimumab 0.8 mg/kg with loss of disease control in Period B received adalimumab 0.8 mg/kg eow for up to 16 weeks in Period C.
11039688|NCT01251614|EG008|Reported Event|Period D: Adalimumab 0.4 mg/kg|Participants received adalimumab 0.4 mg/kg eow for up to 52 weeks in Period D.
11039689|NCT01251614|EG009|Reported Event|Period D: Adalimumab 0.8 mg/kg|Participants received adalimumab 0.8 mg/kg eow for up to 52 weeks in Period D.
11039690|NCT01251653|BG000|Baseline|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039691|NCT01251653|BG001|Baseline|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039692|NCT01251653|BG002|Baseline|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039693|NCT01251653|BG003|Baseline|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039694|NCT01251653|BG004|Baseline|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039695|NCT01251653|BG005|Baseline|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
11039696|NCT01251653|BG006|Baseline|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039697|NCT01251653|BG007|Baseline|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039698|NCT01251653|BG008|Baseline|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039699|NCT01251653|BG009|Baseline|Total|Total of all reporting groups
11039700|NCT01251653|FG000|Participant Flow|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039701|NCT01251653|FG001|Participant Flow|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039702|NCT01251653|FG002|Participant Flow|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039703|NCT01251653|FG003|Participant Flow|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039704|NCT01251653|FG004|Participant Flow|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039705|NCT01251653|FG005|Participant Flow|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
11039706|NCT01251653|FG006|Participant Flow|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039707|NCT01251653|FG007|Participant Flow|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039708|NCT01251653|FG008|Participant Flow|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039709|NCT01251653|OG000|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039710|NCT01251653|OG001|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039711|NCT01251653|OG002|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039712|NCT01251653|OG003|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039713|NCT01251653|OG004|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039714|NCT01251653|OG005|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
11039715|NCT01251653|OG006|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039716|NCT01251653|OG007|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039717|NCT01251653|OG008|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039718|NCT01251653|OG000|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039719|NCT01251653|OG001|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
11039720|NCT01251653|OG002|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039721|NCT01251653|OG000|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039722|NCT01251653|OG001|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
11039723|NCT01251653|OG002|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
11039724|NCT01251653|OG003|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
11039725|NCT01251653|OG004|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039726|NCT01251653|OG005|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
11039727|NCT01251653|OG002|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039728|NCT01251653|OG000|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039729|NCT01251653|OG001|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11348907|NCT04131556|FG000|Participant Flow|Maribavir|Participants received 200 milligrams (mg) of maribavir tablet orally (Treatment A) or 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Treatment B) or maribavir 200 mg powder for oral suspension with 36.1% drug loading (Treatment C) on Day 1 or Day 4 or Day 7 in different sequences of ABC, BCA, CAB, CBA, ACB, and BAC.
11039730|NCT01251653|OG000|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039731|NCT01251653|OG001|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039732|NCT01251653|OG002|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039733|NCT01251653|OG003|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039734|NCT01251653|EG000|Reported Event|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039735|NCT01251653|EG001|Reported Event|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039736|NCT01251653|EG002|Reported Event|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039737|NCT01251653|EG003|Reported Event|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039738|NCT01251653|EG004|Reported Event|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
11039739|NCT01251653|EG005|Reported Event|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039740|NCT01251653|EG006|Reported Event|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039741|NCT01251653|EG007|Reported Event|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039742|NCT01251653|EG008|Reported Event|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
11039743|NCT01251744|BG000|Baseline|CMV Mothers' Group|Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
11039744|NCT01251744|BG001|Baseline|CMV Newborns' Group|Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
11039745|NCT01251744|BG002|Baseline|Total|Total of all reporting groups
11039746|NCT01251744|FG000|Participant Flow|CMV Mothers' Group|Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
11039747|NCT01251744|FG001|Participant Flow|CMV Newborns' Group|Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
11039748|NCT01251744|OG000|Outcome|CMV Offsprings' Group|Offsprings of the CMV Mothers' Group, also tested for CMV infection.
11039749|NCT01251744|OG001|Outcome|CMV Newborns' Group|Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
11039750|NCT01251744|OG002|Outcome|CMV Foetus Group|Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were stillborn or with pregnancy termination.
11039751|NCT01251744|OG000|Outcome|CMV Newborns' Group|Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
11039752|NCT01251744|OG000|Outcome|CMV Infant Group|Offspring of the CMV Mothers' Group, also tested for CMV infection.
11039753|NCT01251744|OG001|Outcome|CMV Newborn Sub-Group|For the purpose of the analysis, this sub-group was divided from the CMV Infant Group, comprising infants that were live born.
11039754|NCT01251744|OG002|Outcome|CMV Foetus Sub-Group|For the purpose of the analysis, this sub-group was divided from the CMV Infant Group, comprising infants that were stillborn or with pregnancy termination.
11039755|NCT01251744|OG000|Outcome|Overall Study Arm|
11039756|NCT01251744|OG000|Outcome|CMV Mothers' Group|Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
11039757|NCT01251744|EG000|Reported Event|CMV Mothers' Group|Pregnant female subjects, 18 years of age or older at the time of study enrollment, with confirmed primary cytomegalovirus (CMV) infection.
11039758|NCT01251744|EG001|Reported Event|CMV Newborns' Group|Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
11039759|NCT01251757|BG000|Baseline|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
11039760|NCT01251757|BG001|Baseline|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.~The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
11348908|NCT04131556|OG000|Outcome|Treatment A|Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
11039761|NCT01251757|BG002|Baseline|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.~The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
11039762|NCT01251757|BG003|Baseline|Total|Total of all reporting groups
11039763|NCT01251757|FG000|Participant Flow|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
11039764|NCT01251757|FG001|Participant Flow|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.~The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
11348909|NCT04131556|OG001|Outcome|Treatment B|Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
11348910|NCT04131556|OG002|Outcome|Treatment C|Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
11039765|NCT01251757|FG002|Participant Flow|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.~The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
11039766|NCT01251757|OG000|Outcome|Usual Care (UC)|statin users in UC arm
11039767|NCT01251757|OG001|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
11039768|NCT01251757|OG002|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
11039769|NCT01251757|OG000|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
11039770|NCT01251757|OG001|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
11039771|NCT01251757|OG002|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
11039772|NCT01251757|OG001|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
11039773|NCT01251757|EG000|Reported Event|Usual Care (UC)|usual medical care
11039774|NCT01251757|EG001|Reported Event|Interactive Voice Recognition (IVR)|usual care plus automated phone calls
11039775|NCT01251757|EG002|Reported Event|Enhanced IVR (IVR+)|usual care plus automated phone calls plus educational mailings and mail follow-up for persistent nonadherence
11039776|NCT01251770|BG000|Baseline|ClNa 0.3%|maintenance solution with ClNa 0.3%
11039777|NCT01251770|BG001|Baseline|ClNa 0.45%|maintenance solution with ClNa 0.45%
11039778|NCT01251770|BG002|Baseline|Total|Total of all reporting groups
11039779|NCT01251770|FG000|Participant Flow|ClNa 0.3%|maintenance solution with ClNa 0.3%
11039780|NCT01251770|FG001|Participant Flow|ClNa 0.45%|maintenance solution with ClNa 0.45%
11039781|NCT01251770|OG000|Outcome|ClNa 0.3%|maintenance solution with ClNa 0.3%
11039782|NCT01251770|OG001|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
11039783|NCT01251770|EG000|Reported Event|ClNa 0.3%|maintenance solution with ClNa 0.3%
11039784|NCT01251770|EG001|Reported Event|ClNa 0.45%|maintenance solution with ClNa 0.45%
10848918|NCT00292591|BG001|Baseline|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11039785|NCT01251887|BG000|Baseline|Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)|Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
11039786|NCT01251887|BG001|Baseline|Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)|Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
11039787|NCT01251887|BG002|Baseline|Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)|Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
11039788|NCT01251887|BG003|Baseline|Total|Total of all reporting groups
11039789|NCT01251887|FG000|Participant Flow|Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)|Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
11039790|NCT01251887|FG001|Participant Flow|Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)|Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
11039791|NCT01251887|FG002|Participant Flow|Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)|Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
11039792|NCT01251887|OG000|Outcome|Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)|Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
11039793|NCT01251887|OG001|Outcome|Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)|Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
11039794|NCT01251887|OG002|Outcome|Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)|Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
11039795|NCT01251887|EG000|Reported Event|Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)|Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
11039796|NCT01251887|EG001|Reported Event|Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)|Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
11039797|NCT01251887|EG002|Reported Event|Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)|Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
11039798|NCT01251965|BG000|Baseline|Ruxolitinib 50 mg BID|Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
11039799|NCT01251965|BG001|Baseline|Ruxolitinib 100 mg BID|Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
11039800|NCT01251965|BG002|Baseline|Ruxolitinib 200 mg BID|Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
11039801|NCT01251965|BG003|Baseline|Total|Total of all reporting groups
11039802|NCT01251965|FG000|Participant Flow|Ruxolitinib 50 mg BID|Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
11039803|NCT01251965|FG001|Participant Flow|Ruxolitinib 100 mg BID|Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
11039804|NCT01251965|FG002|Participant Flow|Ruxolitinib 200 mg BID|Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
11039805|NCT01251965|OG000|Outcome|Ruxolitinib 50 mg BID|Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
11039806|NCT01251965|OG001|Outcome|Ruxolitinib 100 mg BID|Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
11039807|NCT01251965|OG002|Outcome|Ruxolitinib 200 mg BID|Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
11039808|NCT01251965|OG000|Outcome|Ruxolitinib|"Phase I - Starting dose of Ruxolitinib 50 mg by mouth twice a day for 28 day cycle.~Phase II - MTD reached in Phase I.~Ruxolitinib: Phase I - Starting dose of 50 mg by mouth twice a day for 28 day cycle.~Phase II - MTD reached in Phase I."
11039809|NCT01251965|EG000|Reported Event|Ruxolitinib 50 mg BID|Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
11039810|NCT01251965|EG001|Reported Event|Ruxolitinib 100 mg BID|Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
11039811|NCT01251965|EG002|Reported Event|Ruxolitinib 200 mg BID|Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
11039812|NCT01251978|BG000|Baseline|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
11039813|NCT01251978|BG001|Baseline|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
11039814|NCT01251978|BG002|Baseline|Total|Total of all reporting groups
11039815|NCT01251978|FG000|Participant Flow|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
11039816|NCT01251978|FG001|Participant Flow|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
11039817|NCT01251978|OG000|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
11039818|NCT01251978|OG001|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
11039819|NCT01251978|EG000|Reported Event|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
11039820|NCT01251978|EG001|Reported Event|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
11039821|NCT01252095|BG000|Baseline|25 mg Dose|25 mg PG545/week
11039822|NCT01252095|BG001|Baseline|50 mg Dose|50 mg PG545/week
11039823|NCT01252095|BG002|Baseline|Total|Total of all reporting groups
11039824|NCT01252095|FG000|Participant Flow|25 mg Dose|25 mg PG545/week
11039825|NCT01252095|FG001|Participant Flow|50 mg Dose|50 mg PG545/week
11039826|NCT01252095|OG000|Outcome|25 mg Dose|25 mg PG545/week
11039827|NCT01252095|OG001|Outcome|50 mg Dose|50 mg PG545/week
11039828|NCT01252095|EG000|Reported Event|25 mg Dose|25 mg PG545/week
11039829|NCT01252095|EG001|Reported Event|50 mg Dose|50 mg PG545/week
11039830|NCT01252134|BG000|Baseline|Overall|All enrolled participants
11039831|NCT01252134|FG000|Participant Flow|Synergi, Then Biotrue, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
11039832|NCT01252134|FG001|Participant Flow|Synergi, Then OTE, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
11039833|NCT01252134|FG002|Participant Flow|Biotrue, Then OTE, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
11039834|NCT01252134|FG003|Participant Flow|Biotrue, Then Synergi, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
11039835|NCT01252134|FG004|Participant Flow|OTE, Then Biotrue, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
11039836|NCT01252134|FG005|Participant Flow|OTE, Then Synergi, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
11039837|NCT01252134|OG000|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
11039838|NCT01252134|OG001|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
11039839|NCT01252134|OG002|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
11039840|NCT01252134|EG000|Reported Event|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
11039841|NCT01252134|EG001|Reported Event|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
11039842|NCT01252134|EG002|Reported Event|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
11039843|NCT01252147|BG000|Baseline|All Participants|
11039844|NCT01252147|FG000|Participant Flow|All Participants|
11039845|NCT01252147|OG000|Outcome|All Participants|
11039846|NCT01252147|EG000|Reported Event|All Participants|
11039847|NCT01252186|BG000|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
11039848|NCT01252186|BG001|Baseline|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
11039849|NCT01252186|BG002|Baseline|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
11039850|NCT01252186|BG003|Baseline|Total|Total of all reporting groups
11039851|NCT01252186|FG000|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
11039852|NCT01252186|FG001|Participant Flow|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
11039853|NCT01252186|FG002|Participant Flow|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
11039854|NCT01252186|OG000|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
11039855|NCT01252186|OG001|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
11039856|NCT01252186|OG002|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
10848919|NCT00292591|BG002|Baseline|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11039857|NCT01252186|EG000|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
11039858|NCT01252186|EG001|Reported Event|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
11039859|NCT01252186|EG002|Reported Event|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
11039860|NCT01252238|BG000|Baseline|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
10848920|NCT00292591|BG003|Baseline|Total|Total of all reporting groups
11039861|NCT01252238|BG001|Baseline|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
11039862|NCT01252238|BG002|Baseline|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
11039863|NCT01252238|BG003|Baseline|Total|Total of all reporting groups
11039864|NCT01252238|FG000|Participant Flow|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
11039865|NCT01252238|FG001|Participant Flow|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
11039866|NCT01252238|FG002|Participant Flow|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
11039867|NCT01252238|OG000|Outcome|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
11039868|NCT01252238|OG001|Outcome|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
11039869|NCT01252238|OG002|Outcome|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
11039870|NCT01252238|OG000|Outcome|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren: Subject taking combination of valsartan and aliskiren."
11039871|NCT01252238|OG001|Outcome|Aliskiren|Aliskiren: Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
11039872|NCT01252238|OG002|Outcome|Placebo Group|"Only taking Amlodipine~Amlodipine: Taking Amlodipine as prescribed by MD for management of high blood pressure."
11039873|NCT01252238|EG000|Reported Event|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
11039874|NCT01252238|EG001|Reported Event|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
11039875|NCT01252238|EG002|Reported Event|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
11039876|NCT01252251|BG000|Baseline|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
11039877|NCT01252251|FG000|Participant Flow|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
11039878|NCT01252251|OG000|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
11039879|NCT01252251|EG000|Reported Event|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
11039880|NCT01252277|BG000|Baseline|Lovaza™|Lovaza™ (two 1 gram capsules twice daily) for six months
11039881|NCT01252277|FG000|Participant Flow|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
11039882|NCT01252277|OG000|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
11039883|NCT01252277|OG000|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
11039884|NCT01252277|EG000|Reported Event|Lovaza™|"Lovaza™ (two 1 gram capsules twice daily) for six months~Lovaza™: 4 capsules daily for 6 months"
11039885|NCT01252290|BG000|Baseline|Lovaza™|Lovaza™: 4 capsules daily for 6 months
11039886|NCT01252290|FG000|Participant Flow|Lovaza™|Lovaza™: 4 capsules daily for 6 months
11039887|NCT01252290|OG000|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
11039888|NCT01252290|EG000|Reported Event|Lovaza™|Lovaza™: 4 capsules daily for 6 months
11039889|NCT01252355|BG000|Baseline|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
11039890|NCT01252355|BG001|Baseline|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
11039891|NCT01252355|BG002|Baseline|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
11039892|NCT01252355|BG003|Baseline|Total|Total of all reporting groups
11039893|NCT01252355|FG000|Participant Flow|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
11039894|NCT01252355|FG001|Participant Flow|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
11039895|NCT01252355|FG002|Participant Flow|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
11039896|NCT01252355|OG000|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
11039897|NCT01252355|OG001|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
11039898|NCT01252355|OG002|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
11039899|NCT01252355|EG000|Reported Event|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
11039900|NCT01252355|EG001|Reported Event|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
11039901|NCT01252355|EG002|Reported Event|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
11039902|NCT01252563|BG000|Baseline|Amlodipine 10 mg Tablet|Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039903|NCT01252563|FG000|Participant Flow|Amlodipine 10 mg Tablet|Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039904|NCT01252563|OG000|Outcome|Amlodipine 10 mg Tablet|Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039905|NCT01252563|OG000|Outcome|The Achievement Rate to Ambulatory Blood Pressure Goal|The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
11039906|NCT01252563|OG000|Outcome|Changes in Ambulatory SBP From Baseline|changes in ambulatory SBP from baseline at weeks 4, 8, and 12 as well as on the last day of the observation period.
11039907|NCT01252563|OG000|Outcome|Changes in Ambulatory DBP From Baseline|changes in ambulatory DBP from baseline at weeks 4, 8, and 12 as well as on the last day of the observation period.
11039908|NCT01252563|OG000|Outcome|With Complication(s)|Participants who had at least one complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039909|NCT01252563|OG001|Outcome|Without Complication(s)|Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039910|NCT01252563|OG000|Outcome|Male|Male participants who experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039911|NCT01252563|OG001|Outcome|Female|Female participants who experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039912|NCT01252563|OG000|Outcome|With Angina Pectoris|Participants who had angina pectoris as a complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039913|NCT01252563|OG001|Outcome|Without Angina Pectoris|Participants who had no angina pectoris as a complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039914|NCT01252563|OG000|Outcome|With Dyslipidaemia|Participants who had dyslipidaemia as a complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039915|NCT01252563|OG001|Outcome|Without Dyslipidaemia|Participants who had no dyslipidaemia as a complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039916|NCT01252563|OG000|Outcome|With Antihypertensive|Participants who received antihypertensive as a concomitant drug and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039917|NCT01252563|OG001|Outcome|Without Antihypertensive|Participants who received no antihypertensive as a concomitant drug and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11226150|NCT02372006|EG001|Reported Event|Dose Finding - Level 1|"Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11226151|NCT02372006|EG002|Reported Event|Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0|"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area [BSA] using allometric scaling):~Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets.~Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment.~Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter."
11039918|NCT01252563|OG000|Outcome|With ARB|Participants who received ARB as a concomitant drug and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039919|NCT01252563|OG001|Outcome|Without ARB|Participants who received no ARB as a concomitant drug and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
11039920|NCT01252563|OG000|Outcome|With Diabetes Mellitus|Participants with diabetes mellitus as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039921|NCT01252563|OG001|Outcome|Without Diabetes Mellitus|Participants without diabetes mellitus as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039922|NCT01252563|OG000|Outcome|With Chronic Kidney Disease|Participants with chronic kidney disease as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039923|NCT01252563|OG001|Outcome|Without Chronic Kidney Disease|Participants without chronic kidney disease as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039924|NCT01252563|OG000|Outcome|With Myocardial Infarction|Participants with myocardial infarction as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039925|NCT01252563|OG001|Outcome|Without Myocardial Infarction|Participants without myocardial infarction as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039926|NCT01252563|OG000|Outcome|With Metabolic Syndrome|Participants with metabolic syndrome as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039927|NCT01252563|OG001|Outcome|Without Metabolic Syndrome|Participants without metabolic syndrome as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039928|NCT01252563|OG000|Outcome|<120 mmHg at Baseline|Participants with ambulatory SBP of below 120 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039929|NCT01252563|OG001|Outcome|120 to 140 mmHg at Baseline|Participants with ambulatory SBP of 120 to 140 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039930|NCT01252563|OG002|Outcome|140 to 160 mmHg at Baseline|Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039931|NCT01252563|OG003|Outcome|160 to 180 mmHg at Baseline|Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039932|NCT01252563|OG004|Outcome|>= 180 mmHg at Baseline|Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039933|NCT01252563|OG000|Outcome|The Achievement Rate to Home Blood Pressure Goal|The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
11039934|NCT01252563|OG000|Outcome|Changes in Home SBP From Baseline|Mean changes in home SBP from baseline at weeks 4, 8, and 12 as well as on the last day of the observation period.
11039935|NCT01252563|OG000|Outcome|Changes in Home Diastolic Blood Pressure From Baseline|Mean changes in home DBP from baseline at weeks 4, 8, and 12 as well as on the last day of the observation period.
11039936|NCT01252563|EG000|Reported Event|Amlodipine 10 mg Tablet|Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
11039937|NCT01252667|BG000|Baseline|Part 1 - Dose 1 (30 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 30 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039938|NCT01252667|BG001|Baseline|Part 1 - Dose 2 (40 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 40 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039939|NCT01252667|BG002|Baseline|Part 1 - Dose 3 (50 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 50 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039940|NCT01252667|BG003|Baseline|Part 2 - Dose 1 (30 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 30 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039941|NCT01252667|BG004|Baseline|Part 2 - Dose 2 (40 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 40 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039942|NCT01252667|BG005|Baseline|Part 2 - Dose 3 (50 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 50 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039943|NCT01252667|BG006|Baseline|Total|Total of all reporting groups
11149087|NCT01868542|EG000|Reported Event|Insulin Detemir (3-0-3 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :~>6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir."
11039944|NCT01252667|FG000|Participant Flow|Part 1 - Dose 1 (30 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 30 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039945|NCT01252667|FG001|Participant Flow|Part 1 - Dose 2 (40 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 40 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039946|NCT01252667|FG002|Participant Flow|Part 1 - Dose 3 (50 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 50 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039947|NCT01252667|FG003|Participant Flow|Part 2 - Dose 1 (30 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 30 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039948|NCT01252667|FG004|Participant Flow|Part 2 - Dose 2 (40 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 40 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039949|NCT01252667|FG005|Participant Flow|Part 2 - Dose 3 (50 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 50 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039950|NCT01252667|OG000|Outcome|Part 1 - Dose 1 (30 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 30 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11226152|NCT02372058|BG000|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
11226153|NCT02372058|FG000|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
11226154|NCT02372058|OG000|Outcome|BiliCare TcB Average|"The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.~This is the average of both devices"
11226155|NCT02372058|OG001|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
11226156|NCT02372058|OG002|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
11226157|NCT02372058|EG000|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
11226158|NCT02372071|BG000|Baseline|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
11226159|NCT02372071|FG000|Participant Flow|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
11226160|NCT02372071|OG000|Outcome|BiliCare TcB Average|"The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.~This is the average of both devices"
11226161|NCT02372071|OG001|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured routinely for total serum bilirubin
11226162|NCT02372071|EG000|Reported Event|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
11226163|NCT02372097|BG000|Baseline|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
11226164|NCT02372097|BG001|Baseline|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
11226165|NCT02372097|BG002|Baseline|Total|Total of all reporting groups
11039951|NCT01252667|OG001|Outcome|Part 1 - Dose 2 (40 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 40 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11226166|NCT02372097|FG000|Participant Flow|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
11226167|NCT02372097|FG001|Participant Flow|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
11226168|NCT02372097|OG000|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
11226169|NCT02372097|OG001|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
11226170|NCT02372097|EG000|Reported Event|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
11226171|NCT02372097|EG001|Reported Event|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
11226172|NCT02372253|BG000|Baseline|Verapamil|Verapamil SR 360mg Daily
11226173|NCT02372253|BG001|Baseline|Placebo|Matching Placebo
11226174|NCT02372253|BG002|Baseline|Total|Total of all reporting groups
11226175|NCT02372253|FG000|Participant Flow|Verapamil|Verapamil Sustained Release (SR) 360mg Daily
11226176|NCT02372253|FG001|Participant Flow|Placebo|Matching Placebo
11226177|NCT02372253|OG000|Outcome|Verapamil|Verapamil SR 360mg Daily
11226178|NCT02372253|OG001|Outcome|Placebo|Matching Placebo
11226179|NCT02372253|OG000|Outcome|Verapamil|"13-26 subjects with Type 1 Diabetes meeting the inclusion criteria will be randomly assigned to receive daily oral verapamil for 12 months. The initial dose of verapamil will be 120 mg daily, and this will be advanced if tolerated to a maximum dose of 360 mg daily. The verapamil tablets will be encapsulated to match the placebo capsules~Verapamil"
11226180|NCT02372253|OG001|Outcome|Placebo|"13-26 subjects with Type 1 Diabetes meeting the inclusion criteria will be randomly assigned to receive daily oral placebo for 12 months. The initial dose of placebo will be 120 mg daily, and this will be advanced if tolerated to a maximum dose of 360 mg daily. The placebo tablets will be encapsulated to match the verapamil capsules~Placebo"
11226181|NCT02372253|EG000|Reported Event|Verapamil|Verapamil SR 360mg Daily
11226182|NCT02372253|EG001|Reported Event|Placebo|Matching Placebo
11226183|NCT02372344|BG000|Baseline|AZD0585|All subjects received a single oral dose of 4 g AZD0585 on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions. Each dose was administered on Day 1 of each separate treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
11039952|NCT01252667|OG002|Outcome|Part 1 - Dose 3 (50 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 50 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039953|NCT01252667|OG003|Outcome|Part 2 - Dose 1 (30 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 30 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039954|NCT01252667|OG004|Outcome|Part 2 - Dose 2 (40 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 40 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039955|NCT01252667|OG005|Outcome|Part 2 - Dose 3 (50 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 50 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11226184|NCT02372344|FG000|Participant Flow|Sequence ABC|"Subjects randomized to treatment sequence ABC: A=fasting / B=before meal / C=after meal.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
11226185|NCT02372344|FG001|Participant Flow|Sequence BCA|"Subjects randomized to treatment sequence BCA: B=before meal / C=after meal / A=fasting.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
11226186|NCT02372344|FG002|Participant Flow|Sequence CAB|"Subjects randomized to treatment sequence CAB: C=after meal / A=fasting / B=before meal.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
11226187|NCT02372344|OG000|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
11226188|NCT02372344|OG001|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
11226189|NCT02372344|OG002|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
11226190|NCT02372344|EG000|Reported Event|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
11226191|NCT02372344|EG001|Reported Event|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
11226192|NCT02372344|EG002|Reported Event|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
10848921|NCT00292591|FG000|Participant Flow|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11226193|NCT02372383|BG000|Baseline|CF Subjects|"Fasting State Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug~Food/Enzymes State Subjects with CF will then cross-over and be given the same dose of the 3 antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase). CF subjects will be randomized to either receive the medications in the Fasting or Food/Enzymes state first."
11039956|NCT01252667|EG000|Reported Event|Part 1 - Dose 1 (30 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 30 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039957|NCT01252667|EG001|Reported Event|Part 1 - Dose 2 (40 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 40 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039958|NCT01252667|EG002|Reported Event|Part 1 - Dose 3 (50 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 50 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039959|NCT01252667|EG003|Reported Event|Part 2 - Dose 1 (30 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 30 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039960|NCT01252667|EG004|Reported Event|Part 2 - Dose 2 (40 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 40 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039961|NCT01252667|EG005|Reported Event|Part 2 - Dose 3 (50 mg/m^2 Clofarabine)|"CONDITIONING REGIMEN: Patients receive 50 mg/m^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.~IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Clofarabine: Given IV~Cyclosporine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT~Pharmacological Study: Optional correlative studies~Total-Body Irradiation: Undergo TBI"
11039962|NCT01252732|BG000|Baseline|Single-Dose 1200 mg Oritavancin|Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.
11039963|NCT01252732|BG001|Baseline|Vancomycin|IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
11039964|NCT01252732|BG002|Baseline|Total|Total of all reporting groups
11039965|NCT01252732|FG000|Participant Flow|Single-Dose 1200 mg Oritavancin|Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.
11039966|NCT01252732|FG001|Participant Flow|Vancomycin|IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
11039967|NCT01252732|OG000|Outcome|Single-Dose 1200 mg Oritavancin|Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.
11039968|NCT01252732|OG001|Outcome|Vancomycin|IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
11039969|NCT01252732|EG000|Reported Event|Single-Dose 1200 mg Oritavancin|Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.
11039970|NCT01252732|EG001|Reported Event|Vancomycin|IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
11039971|NCT01252745|BG000|Baseline|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
11039972|NCT01252745|BG001|Baseline|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
10848922|NCT00292591|FG001|Participant Flow|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11039973|NCT01252745|BG002|Baseline|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
11039974|NCT01252745|BG003|Baseline|Total|Total of all reporting groups
11039975|NCT01252745|FG000|Participant Flow|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
11039976|NCT01252745|FG001|Participant Flow|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
11039977|NCT01252745|FG002|Participant Flow|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
11039978|NCT01252745|OG000|Outcome|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
11039979|NCT01252745|OG001|Outcome|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
11039980|NCT01252745|OG002|Outcome|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
11039981|NCT01252745|OG000|Outcome|10.0 mg of TBS-1, 4.0% T.I.D.|"TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)~10.0 mg of Testosterone, 4.0% TID"
11039982|NCT01252745|OG001|Outcome|13.5 mg of TBS-1, 4.5% B.I.D|"TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)~13.5 mg of Testosterone, 4.5% B.I.D"
11039983|NCT01252745|OG002|Outcome|11.25 mg of TBS-1, 4.5% T.I.D|"TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)~11.25 mg of Testosterone, 4.5% T.I.D"
11039984|NCT01252745|EG000|Reported Event|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
11039985|NCT01252745|EG001|Reported Event|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
11039986|NCT01252745|EG002|Reported Event|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
11039987|NCT01252810|BG000|Baseline|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
11039988|NCT01252810|BG001|Baseline|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
11039989|NCT01252810|BG002|Baseline|Total|Total of all reporting groups
11039990|NCT01252810|FG000|Participant Flow|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
11039991|NCT01252810|FG001|Participant Flow|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
11039992|NCT01252810|OG000|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
11039993|NCT01252810|OG001|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
11039994|NCT01252810|EG000|Reported Event|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration. Up to 7 days post Iopamidol administration.
11039995|NCT01252810|EG001|Reported Event|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration. Up to 7 days post Ioforminol administration.
11039996|NCT01252940|BG000|Baseline|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
11039997|NCT01252940|BG001|Baseline|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
11039998|NCT01252940|BG002|Baseline|Total|Total of all reporting groups
11039999|NCT01252940|FG000|Participant Flow|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
11040000|NCT01252940|FG001|Participant Flow|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
11040001|NCT01252940|OG000|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
11040002|NCT01252940|OG001|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
11040003|NCT01252940|EG000|Reported Event|FTC/RPV/TDF|The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
11040004|NCT01252940|EG001|Reported Event|SBR/Delayed Switch (up to Week 24)|The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
11040005|NCT01252940|EG002|Reported Event|SBR/Delayed Switch (After Week 24)|The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.
11348911|NCT04131556|OG000|Outcome|Maribavir|Participants received 200 milligrams (mg) of maribavir tablet orally (Treatment A) or 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Treatment B) or maribavir 200 mg powder for oral suspension with 36.1% drug loading (Treatment C) on Day 1 or Day 4 or Day 7 in different sequences of ABC, BCA, CAB, CBA, ACB, and BAC.
11040006|NCT01252966|BG000|Baseline|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
11040007|NCT01252966|BG001|Baseline|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
11040008|NCT01252966|BG002|Baseline|Total|Total of all reporting groups
11040009|NCT01252966|FG000|Participant Flow|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
11040010|NCT01252966|FG001|Participant Flow|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
11040011|NCT01252966|OG000|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
11040012|NCT01252966|OG001|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
11040013|NCT01252966|OG000|Outcome|Cognitive Training|The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
11040014|NCT01252966|OG001|Outcome|Control Training|The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.
11040015|NCT01252966|EG000|Reported Event|Cognitive Training|
11040016|NCT01252966|EG001|Reported Event|Control Training|
11040017|NCT01253018|BG000|Baseline|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
11040018|NCT01253018|BG001|Baseline|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
11040019|NCT01253018|BG002|Baseline|Total|Total of all reporting groups
11040020|NCT01253018|FG000|Participant Flow|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using 2 different robots in a sequential 4 week progression in 3 distinct modules: wrist, shoulder-elbow and alternating sessions of wrist and shoulder-elbow robot. Sessions were 3x/week x 60 minutes.
11040021|NCT01253018|FG001|Participant Flow|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
11040022|NCT01253018|OG000|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
11040023|NCT01253018|OG001|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
11040024|NCT01253018|OG001|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
11040025|NCT01253018|EG000|Reported Event|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
11040026|NCT01253018|EG001|Reported Event|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
11040027|NCT01253044|BG000|Baseline|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
11040028|NCT01253044|BG001|Baseline|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
11040029|NCT01253044|BG002|Baseline|Total|Total of all reporting groups
11040030|NCT01253044|FG000|Participant Flow|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
11040031|NCT01253044|FG001|Participant Flow|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
11040032|NCT01253044|OG000|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
11040033|NCT01253044|OG001|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
11040034|NCT01253044|EG000|Reported Event|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
11040035|NCT01253044|EG001|Reported Event|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
11040036|NCT01253135|BG000|Baseline|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
11040037|NCT01253135|FG000|Participant Flow|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
11040038|NCT01253135|OG000|Outcome|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
11040039|NCT01253135|OG001|Outcome|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
11040040|NCT01253135|OG000|Outcome|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
11040041|NCT01253135|OG001|Outcome|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
11040042|NCT01253135|EG000|Reported Event|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
11040043|NCT01253135|EG001|Reported Event|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
11040044|NCT01253148|BG000|Baseline|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
11040045|NCT01253148|FG000|Participant Flow|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
11040046|NCT01253148|OG000|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
11040047|NCT01253148|EG000|Reported Event|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
11040048|NCT01253174|BG000|Baseline|Entire Study Population|Includes all participants treated
11040049|NCT01253174|FG000|Participant Flow|Treatment Sequence A: Yasmin, EE30/DRSP/L-5-MTHF Ca, Metafolin|Yasmin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
11040050|NCT01253174|FG001|Participant Flow|Treatment Sequence B: Yasmin, Metafolin, EE30/DRSP/L-5-MTHF Ca|Yasmin for Period 1; Metafolin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
11040051|NCT01253174|FG002|Participant Flow|Treatment Sequence C: EE30/DRSP/L-5-MTHF Ca, Yasmin, Metafolin|EE30/DRSP/L-5-MTHF Ca for Period 1; Yasmin for Period 2; Metafolin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
11040052|NCT01253174|FG003|Participant Flow|Treatment Sequence D: EE30/DRSP/L-5-MTHF Ca, Metafolin, Yasmin|EE30/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; Yasmin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
11040053|NCT01253174|FG004|Participant Flow|Treatment Sequence E: Metafolin, Yasmin, EE30/DRSP/L-5-MTHF Ca|Metafolin for Period 1; Yasmin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
11040054|NCT01253174|FG005|Participant Flow|Treatment Sequence F: Metafolin, EE30/DRSP/L-5-MTHF Ca, Yasmin|Metafolin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Yasmin for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
11040055|NCT01253174|OG000|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
11040056|NCT01253174|OG001|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
11040057|NCT01253174|OG000|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
11040058|NCT01253174|OG001|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
11040059|NCT01253174|EG000|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
11040060|NCT01253174|EG001|Reported Event|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
11040061|NCT01253174|EG002|Reported Event|L-5-MTHF Ca 0.451mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
11040062|NCT01253187|BG000|Baseline|Entire Study Population|Includes all participants treated
11040063|NCT01253187|FG000|Participant Flow|Treatment Sequence A: YAZ, EE20/DRSP/L-5-MTHF Ca, Metafolin|YAZ for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
11040064|NCT01253187|FG001|Participant Flow|Treatment Sequence B: YAZ, Metafolin, EE20/DRSP/L-5-MTHF Ca|YAZ for Period 1; Metafolin for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
11040065|NCT01253187|FG002|Participant Flow|Treatment Sequence C: EE20/DRSP/L-5-MTHF Ca, YAZ, Metafolin|EE20/DRSP/L-5-MTHF Ca for Period 1; YAZ for Period 2; Metafolin for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
11040066|NCT01253187|FG003|Participant Flow|Treatment Sequence D: EE20/DRSP/L-5-MTHF Ca, Metafolin, YAZ|EE20/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; YAZ for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
11040067|NCT01253187|FG004|Participant Flow|Treatment Sequence E: Metafolin, YAZ, EE20/DRSP/L-5-MTHF Ca|Metafolin for Period 1; YAZ for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
11040068|NCT01253187|FG005|Participant Flow|Treatment Sequence F: Metafolin, EE20/DRSP/L-5-MTHF Ca, YAZ|Metafolin for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; YAZ for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
11040069|NCT01253187|OG000|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
11040070|NCT01253187|OG001|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
11040071|NCT01253187|OG000|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
11040072|NCT01253187|OG001|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium) [L-5-MTHF Ca]
11040073|NCT01253187|OG001|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
11040074|NCT01253187|OG000|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
11040075|NCT01253187|EG000|Reported Event|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
11040076|NCT01253187|EG001|Reported Event|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
11040077|NCT01253187|EG002|Reported Event|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
11040078|NCT01253200|BG000|Baseline|Randomized Blazer® Open-Irrigated Ablation Catheter|Patients randomized to treatment with the Blazer® Open-Irrigated Ablation Catheter
11040079|NCT01253200|BG001|Baseline|Randomized Control Catheter|"Patients randomized to treatment with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
11040080|NCT01253200|BG002|Baseline|Roll-In Blazer® Open-Irrigated Ablation Catheter|The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
11040081|NCT01253200|BG003|Baseline|Roll-In Control Catheter|The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis
11040082|NCT01253200|BG004|Baseline|Not Randomized to Any Treatment Group|Subjects not Randomized to any treatment group and were not Roll-in subjects
11040083|NCT01253200|BG005|Baseline|Total|Total of all reporting groups
11040084|NCT01253200|FG000|Participant Flow|Randomized Blazer® Open-Irrigated Ablation Catheter|"Randomized Patients treated with the Blazer® Open-Irrigated Ablation Catheter~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter"
11040085|NCT01253200|FG001|Participant Flow|Randomized Control Catheter|"Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
11040086|NCT01253200|FG002|Participant Flow|Roll-in Blazer Open Irrigated Subjects|The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
11040087|NCT01253200|FG003|Participant Flow|Roll-in Control Catheter|The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
11040088|NCT01253200|FG004|Participant Flow|Not Randomized to Any Treatment Group Subjects|Five subjects were not Randomized to any treatment group and were not Roll-in subjects.
11040089|NCT01253200|OG000|Outcome|Blazer® Open-Irrigated Ablation Catheter|"Patients treated with the Blazer® Open-Irrigated Ablation Catheter~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter"
11040090|NCT01253200|OG001|Outcome|Control Catheter|"Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
11040091|NCT01253200|EG000|Reported Event|Randomized Blazer® Open-Irrigated Ablation Catheter|"Randomized patients treated with the Blazer® Open-Irrigated Ablation Catheter (procedure patients)~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
11040092|NCT01253200|EG001|Reported Event|Randomized Control Catheter|"Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter (procedure patients)~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
11040093|NCT01253200|EG002|Reported Event|Roll-in Blazer® Open-Irrigated Ablation Catheter|"Roll-in patients treated with the Blazer® Open-Irrigated Ablation Catheter (procedure patients)~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
11040094|NCT01253200|EG003|Reported Event|Roll-in Control Catheter|"Roll-in patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter (procedure patients)~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
11040095|NCT01253200|EG004|Reported Event|Non-Randomized to Any Treatment Group|"Five subjects were not randomized to any treatment group and were not Roll-in subjects. Therefore, these five subjects were not treated with the Blazer Open-irrigated catheter or a Control catheter.~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
11040096|NCT01253226|BG000|Baseline|30 mg Tabalumab Q4W|Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040097|NCT01253226|BG001|Baseline|60 mg Tabalumab Q4W|Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040098|NCT01253226|BG002|Baseline|120 mg Tabalumab Q4W|Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040099|NCT01253226|BG003|Baseline|120 mg Tabalumab Q2W|Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
11040100|NCT01253226|BG004|Baseline|Placebo|"Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).~Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20)."
11040101|NCT01253226|BG005|Baseline|Total|Total of all reporting groups
11040102|NCT01253226|FG000|Participant Flow|30 mg Tabalumab Q4W|Tabalumab: 30 milligrams (mg) subcutaneous (SC) injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040103|NCT01253226|FG001|Participant Flow|60 mg Tabalumab Q4W|Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040104|NCT01253226|FG002|Participant Flow|120 mg Tabalumab Q4W|Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040105|NCT01253226|FG003|Participant Flow|120 mg Tabalumab Q2W|Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
11040106|NCT01253226|FG004|Participant Flow|Placebo|"Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).~Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20)."
11040107|NCT01253226|OG000|Outcome|30 mg Tabalumab Q4W|Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040108|NCT01253226|OG001|Outcome|60 mg Tabalumab Q4W|Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040109|NCT01253226|OG002|Outcome|120 mg Tabalumab Q4W|Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040110|NCT01253226|OG003|Outcome|120 mg Tabalumab Q2W|Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
11040111|NCT01253226|OG004|Outcome|Placebo|"Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).~Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20)."
11040112|NCT01253226|EG000|Reported Event|30 mg Tabalumab Q4W|Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040113|NCT01253226|EG001|Reported Event|60 mg Tabalumab Q4W|Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040114|NCT01253226|EG002|Reported Event|120 mg Tabalumab Q4W|Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
11040115|NCT01253226|EG003|Reported Event|120 mg Tabalumab Q2W|Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
11040116|NCT01253226|EG004|Reported Event|Placebo|"Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).~Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20)."
11040117|NCT01253265|BG000|Baseline|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040118|NCT01253265|BG001|Baseline|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040119|NCT01253265|BG002|Baseline|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040120|NCT01253265|BG003|Baseline|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
11040121|NCT01253265|BG004|Baseline|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
10848923|NCT00292591|FG002|Participant Flow|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11040122|NCT01253265|BG005|Baseline|Total|Total of all reporting groups
11040123|NCT01253265|FG000|Participant Flow|30 Milligram (mg) LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040124|NCT01253265|FG001|Participant Flow|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040125|NCT01253265|FG002|Participant Flow|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040126|NCT01253265|FG003|Participant Flow|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
11040127|NCT01253265|FG004|Participant Flow|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
11040128|NCT01253265|OG000|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040129|NCT01253265|OG001|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040130|NCT01253265|OG002|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040131|NCT01253265|OG003|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
11040132|NCT01253265|OG004|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
11040133|NCT01253265|EG000|Reported Event|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040134|NCT01253265|EG001|Reported Event|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040135|NCT01253265|EG002|Reported Event|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
11040136|NCT01253265|EG003|Reported Event|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
11040137|NCT01253265|EG004|Reported Event|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
11040138|NCT01253291|BG000|Baseline|Placebo/LY2127399 120 mg Q4W|Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040139|NCT01253291|BG001|Baseline|LY2127399 30 mg Q4W/120 mg Q4W|Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040140|NCT01253291|BG002|Baseline|LY2127399 60 mg Q4W/120 mg Q4W|Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040141|NCT01253291|BG003|Baseline|LY2127399 120 mg Q4W/120 mg Q4W|Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040142|NCT01253291|BG004|Baseline|LY2127399 120 mg Q2W/120 mg Q4W|Participants who previously received 120 mg of LY2127399 Q2W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040143|NCT01253291|BG005|Baseline|Total|Total of all reporting groups
11040144|NCT01253291|FG000|Participant Flow|Placebo/LY2127399 120 mg Q4W|Participants who previously received placebo in Study BCDK were assigned to receive 120 milligrams (mg) of LY2127399 administered subcutaneously (SC) once every 4 weeks (Q4W) for 48 weeks.
11040145|NCT01253291|FG001|Participant Flow|LY2127399 30 mg Q4W/120 mg Q4W|Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040146|NCT01253291|FG002|Participant Flow|LY2127399 60 mg Q4W/120 mg Q4W|Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040147|NCT01253291|FG003|Participant Flow|LY2127399 120 mg Q4W/120 mg Q4W|Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040148|NCT01253291|FG004|Participant Flow|LY2127399 120 mg Q2W/120 mg Q4W|Participants who previously received 120 mg of LY2127399 every 2 weeks (Q2W) in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040149|NCT01253291|OG000|Outcome|Placebo/LY2127399 120 mg Q4W|Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040150|NCT01253291|OG001|Outcome|LY2127399 30 mg Q4W/120 mg Q4W|Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040151|NCT01253291|OG002|Outcome|LY2127399 60 mg Q4W/120 mg Q4W|Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040152|NCT01253291|OG003|Outcome|LY2127399 120 mg Q4W/120 mg Q4W|Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040153|NCT01253291|OG004|Outcome|LY2127399 120 mg Q2W/120 mg Q4W|Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040154|NCT01253291|OG000|Outcome|120 mg LY2127399 Q4W|Participants who previously received placebo or 30 mg Q4W up to 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040155|NCT01253291|EG000|Reported Event|Placebo/LY2127399 120 mg Q4W|Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040156|NCT01253291|EG001|Reported Event|LY2127399 30 mg Q4W/120 mg Q4W|Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040157|NCT01253291|EG002|Reported Event|LY2127399 60 mg Q4W/120 mg Q4W|Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040158|NCT01253291|EG003|Reported Event|LY2127399 120 mg Q4W/120 mg Q4W|Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040159|NCT01253291|EG004|Reported Event|LY2127399 120 mg Q2W/120 mg Q4W|Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
11040160|NCT01253304|BG000|Baseline|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
11040161|NCT01253304|BG001|Baseline|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
11040162|NCT01253304|BG002|Baseline|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
11040163|NCT01253304|BG003|Baseline|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
11040164|NCT01253304|BG004|Baseline|Total|Total of all reporting groups
11040165|NCT01253304|FG000|Participant Flow|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
11040166|NCT01253304|FG001|Participant Flow|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
11348912|NCT04131556|EG000|Reported Event|Maribavir|Participants received 200 milligrams (mg) of maribavir tablet orally (Treatment A) or 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Treatment B) or maribavir 200 mg powder for oral suspension with 36.1% drug loading (Treatment C) on Day 1 or Day 4 or Day 7 in different sequences of ABC, BCA, CAB, CBA, ACB, and BAC.
11040167|NCT01253304|FG002|Participant Flow|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
11040168|NCT01253304|FG003|Participant Flow|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
11040169|NCT01253304|OG000|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
11040170|NCT01253304|OG001|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
11040171|NCT01253304|OG002|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
11040172|NCT01253304|OG003|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
11040173|NCT01253304|EG000|Reported Event|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
11040174|NCT01253304|EG001|Reported Event|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
11040175|NCT01253304|EG002|Reported Event|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
11040176|NCT01253304|EG003|Reported Event|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
11040177|NCT01253317|BG000|Baseline|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
11040178|NCT01253317|FG000|Participant Flow|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
11040179|NCT01253317|OG000|Outcome|4-week Multiple Ascending Dose (MAD)|Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, and evaluating safety and tolerability of IGF-1.
11040180|NCT01253317|OG001|Outcome|20-week Open Label Extension (OLE)|10 subjects that previously participated in the MAD went on to complete the OLE and were monitoring for safety of prolonged treatment (20 weeks).
11040181|NCT01253317|OG000|Outcome|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
11226194|NCT02372383|BG001|Baseline|Healthy Controls (Fasting Only)|"Healthy subjects without CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug"
11040182|NCT01253317|OG000|Outcome|MAD and OLE Treatment Periods|Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, and evaluating safety and tolerability of IGF-1. Ten subjects that previously participated in the MAD went on to complete the OLE and were monitoring for safety of prolonged treatment (20 weeks).
11040183|NCT01253317|OG000|Outcome|20-week Open Label Extension (OLE)|10 subjects that previously participated in the MAD went on to complete the OLE and were monitored for safety of prolonged treatment (20 weeks).
11040184|NCT01253317|EG000|Reported Event|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
11040185|NCT01253343|BG000|Baseline|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score ≥ 8.
11040186|NCT01253343|BG001|Baseline|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score ≤6.5.
11040187|NCT01253343|BG002|Baseline|Total|Total of all reporting groups
11040188|NCT01253343|FG000|Participant Flow|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
11040189|NCT01253343|FG001|Participant Flow|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
11226195|NCT02372383|BG002|Baseline|Total|Total of all reporting groups
11040190|NCT01253343|OG000|Outcome|Low Aggression Group + Cortisol Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
11040191|NCT01253343|OG001|Outcome|Low Aggression Group + Cortisol Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
11040192|NCT01253343|OG002|Outcome|Low Aggression Group + Cortisol Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
11040193|NCT01253343|OG003|Outcome|High Aggression Group + Cortisol Sample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
11040194|NCT01253343|OG004|Outcome|High Aggression Group + Cortisol Sample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
11040195|NCT01253343|OG005|Outcome|High Aggression Group + Cortisol Sample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
11040196|NCT01253343|OG000|Outcome|Low Aggression Group + DHEA Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
11348913|NCT04126174|BG000|Baseline|All Participants|Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
11040197|NCT01253343|OG001|Outcome|Low Aggression Group + DHEA Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
11040198|NCT01253343|OG002|Outcome|Low Aggression Group + DHEA Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
11040199|NCT01253343|OG003|Outcome|Low Aggression Group + TestosteroneSample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
11040200|NCT01253343|OG004|Outcome|Low Aggression Group + TestosteroneSample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
11040201|NCT01253343|OG005|Outcome|Low Aggression Group + TestosteroneSample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
11040202|NCT01253343|OG006|Outcome|High Aggression Group + DHEASample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
11040203|NCT01253343|OG007|Outcome|High Aggression Group + DHEASample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
11040204|NCT01253343|OG008|Outcome|High Aggression Group + DHEASample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
11040205|NCT01253343|OG009|Outcome|High Aggression Group + TestosteroneSample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
11040206|NCT01253343|OG010|Outcome|High Aggression Group + TestosteroneSample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
11040207|NCT01253343|OG011|Outcome|High Aggression Group + TestosteroneSample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
11040208|NCT01253343|EG000|Reported Event|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
11040209|NCT01253343|EG001|Reported Event|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
11040210|NCT01253369|BG000|Baseline|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
11040211|NCT01253369|FG000|Participant Flow|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
11040212|NCT01253369|OG000|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
11040213|NCT01253369|EG000|Reported Event|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
11040214|NCT01253408|BG000|Baseline|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
11040215|NCT01253408|BG001|Baseline|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
11040216|NCT01253408|BG002|Baseline|Placebo|Placebo will be taken orally with water twice per day for two days.
11348914|NCT04126174|FG000|Participant Flow|Femtosecond Limbal Relaxing Incision (LRI)|"Eyes will be treated with arcuate incisions from a femtosecond laser system.~femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system."
11040217|NCT01253408|BG003|Baseline|Total|Total of all reporting groups
11040218|NCT01253408|FG000|Participant Flow|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
11040219|NCT01253408|FG001|Participant Flow|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
11040220|NCT01253408|FG002|Participant Flow|Placebo|Placebo will be taken orally with water twice per day for two days.
11040221|NCT01253408|OG000|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
11040222|NCT01253408|OG001|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
11040223|NCT01253408|OG002|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
11040224|NCT01253408|EG000|Reported Event|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
11040225|NCT01253408|EG001|Reported Event|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
11040226|NCT01253408|EG002|Reported Event|Placebo|Placebo will be taken orally with water twice per day for two days.
11040227|NCT01253421|BG000|Baseline|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
11040228|NCT01253421|BG001|Baseline|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
11040229|NCT01253421|BG002|Baseline|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
11040230|NCT01253421|BG003|Baseline|HC-placebo|Subjects having no history of mental disorder who received placebo
11040231|NCT01253421|BG004|Baseline|Total|Total of all reporting groups
11040232|NCT01253421|FG000|Participant Flow|All Participants Prior to Randomization|All Participants went through Assessment, prior to randomization.
11040233|NCT01253421|FG001|Participant Flow|MDD-amisulpride|Subjects experiencing a current episode of major depression who are randomized to receive amisulpride
11040234|NCT01253421|FG002|Participant Flow|MDD-placebo|Subjects experiencing a current episode of major depression who are randomized to receive placebo
11040235|NCT01253421|FG003|Participant Flow|HC-amisulpride|Subjects having no history of mental disorder who are randomized to receive amisulpride
11040236|NCT01253421|FG004|Participant Flow|HC-placebo|Subjects having no history of mental disorder who are randomized to receive placebo
11040237|NCT01253421|OG000|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
11348915|NCT04126174|FG001|Participant Flow|Manual LRI|"Eyes will be treated with arcuate incisions completed manually with a blade.~Manual LRI: Manual LRI"
11040238|NCT01253421|OG001|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
11040239|NCT01253421|OG002|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
11040240|NCT01253421|OG003|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
11040241|NCT01253421|EG000|Reported Event|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
11040242|NCT01253421|EG001|Reported Event|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
11040243|NCT01253421|EG002|Reported Event|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
11040244|NCT01253421|EG003|Reported Event|HC-placebo|Subjects having no history of mental disorder who received placebo
11040245|NCT01253447|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
11040246|NCT01253447|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
11040247|NCT01253447|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
11040248|NCT01253447|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle~Akt inhibitor MK2206: 200 mg orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative studies"
11040249|NCT01253447|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
11040250|NCT01253460|BG000|Baseline|Cyclophosphamide, Rituximab + Sapacitabine|"After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.~Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.~Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.~Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course."
11040251|NCT01253460|FG000|Participant Flow|Cyclophosphamide, Rituximab + Sapacitabine|"After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.~Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.~Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.~Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course."
11040252|NCT01253460|OG000|Outcome|Cyclophosphamide, Rituximab + Sapacitabine|"After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.~Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.~Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.~Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course."
11040253|NCT01253460|EG000|Reported Event|Cyclophosphamide, Rituximab + Sapacitabine|"After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.~Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.~Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.~Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course."
11040254|NCT01253525|BG000|Baseline|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
11040255|NCT01253525|FG000|Participant Flow|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
11040256|NCT01253525|OG000|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
11040257|NCT01253525|EG000|Reported Event|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
11040258|NCT01253564|BG000|Baseline|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
11040259|NCT01253564|FG000|Participant Flow|Vemurafenib|Participants received vemurafenib tablets, 960 milligrams (mg), twice daily (BID), orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
11040260|NCT01253564|OG000|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
11040261|NCT01253564|EG000|Reported Event|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
11348916|NCT04126174|OG000|Outcome|Femtosecond Limbal Relaxing Incision (LRI)|"Eyes will be treated with arcuate incisions from a femtosecond laser system.~femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system."
11040262|NCT01253577|BG000|Baseline|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
11040263|NCT01253577|FG000|Participant Flow|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
11040264|NCT01253577|OG000|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
11040265|NCT01253577|OG001|Outcome|Non-coated Implant Side|Sinus stent without drug coating
11040266|NCT01253577|OG000|Outcome|All Subjects|
11040267|NCT01253577|EG000|Reported Event|All Patients|Patients served as their own controls in the study, with a drug-coated stent placed on one sinus side and a non-drug-coated control placed on contralateral side. Therefore adverse events are listed for the entire 105-patient cohort rather than by treatment group.
11040268|NCT01253642|BG000|Baseline|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
11040269|NCT01253642|FG000|Participant Flow|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
11040270|NCT01253642|OG000|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
11040271|NCT01253642|OG000|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
11040272|NCT01253642|EG000|Reported Event|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
11040273|NCT01253811|BG000|Baseline|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
11040274|NCT01253811|FG000|Participant Flow|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
11040275|NCT01253811|OG000|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
11040276|NCT01253811|EG000|Reported Event|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
11040277|NCT01253824|BG000|Baseline|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
11040278|NCT01253824|BG001|Baseline|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
11040279|NCT01253824|BG002|Baseline|Total|Total of all reporting groups
11040280|NCT01253824|FG000|Participant Flow|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
11040281|NCT01253824|FG001|Participant Flow|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
11040282|NCT01253824|OG000|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
11040283|NCT01253824|OG001|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
11040284|NCT01253824|EG000|Reported Event|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
11040285|NCT01253824|EG001|Reported Event|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
11040286|NCT01253902|BG000|Baseline|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040287|NCT01253902|BG001|Baseline|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040288|NCT01253902|BG002|Baseline|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040289|NCT01253902|BG003|Baseline|Total|Total of all reporting groups
11040290|NCT01253902|FG000|Participant Flow|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040291|NCT01253902|FG001|Participant Flow|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040292|NCT01253902|FG002|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040293|NCT01253902|OG000|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040294|NCT01253902|OG001|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040295|NCT01253902|OG002|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040296|NCT01253902|EG000|Reported Event|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040297|NCT01253902|EG001|Reported Event|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040298|NCT01253902|EG002|Reported Event|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
11040299|NCT01253980|BG000|Baseline|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
11040300|NCT01253980|BG001|Baseline|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
11040301|NCT01253980|BG002|Baseline|Total|Total of all reporting groups
11040302|NCT01253980|FG000|Participant Flow|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
11040303|NCT01253980|FG001|Participant Flow|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
11040304|NCT01253980|OG000|Outcome|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
11040305|NCT01253980|OG001|Outcome|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
11040306|NCT01253980|EG000|Reported Event|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
10848924|NCT00292591|OG000|Outcome|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11040307|NCT01253980|EG001|Reported Event|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
11040308|NCT01254019|BG000|Baseline|Placebo|Participants received single dose of matching placebo sterile solution for subcutaneous injection preferably in the morning over the 48 week treatment period.
11040309|NCT01254019|BG001|Baseline|GSK2402968 6mg/kg/Week|Participants received single dose of GSK2402968 6 mg/kg/week subcutaneous injection preferably in the morning over the 48 week treatment period.
11040310|NCT01254019|BG002|Baseline|Total|Total of all reporting groups
11040311|NCT01254019|FG000|Participant Flow|Placebo|Participants received single dose of matching placebo sterile solution for subcutaneous injection preferably in the morning over the 48 week treatment period.
11040312|NCT01254019|FG001|Participant Flow|GSK2402968 6mg/kg/Week|Participants received single dose of GSK2402968 6 milligrams per kilogram per week (mg/kg/week) subcutaneous injection preferably in the morning over the 48 week treatment period.
11040313|NCT01254019|OG000|Outcome|Placebo|Participants received single dose of matching placebo sterile solution for subcutaneous injection preferably in the morning over the 48 week treatment period.
11040314|NCT01254019|OG001|Outcome|GSK2402968 6mg/kg/Week|Participants received single dose of GSK2402968 6 mg/kg/week subcutaneous injection preferably in the morning over the 48 week treatment period.
11040315|NCT01254019|OG000|Outcome|Placebo|Participants received single dose of matching placebo 1 mL sterile solution for subcutaneous injection preferably in the morning over the 48 week treatment period.
11040316|NCT01254019|OG001|Outcome|GSK2402968 6mg/kg/Week|Participants received single dose of GSK2402968 6 mg/kg/week subcutaneous injection preferably in the morning over the 48 week treatment period
11040317|NCT01254019|OG000|Outcome|GSK2402968 6mg/kg/Week|Participants received single dose of GSK2402968 6 mg/kg/week subcutaneous injection preferably in the morning over the 48 week treatment period.
11040318|NCT01254019|EG000|Reported Event|Placebo|Participants received single dose of matching placebo sterile solution for subcutaneous injection preferably in the morning over the 48 week treatment period.
11040319|NCT01254019|EG001|Reported Event|GSK2402968 6mg/kg/Week|Participants received single dose of GSK2402968 6 mg/kg/week subcutaneous injection preferably in the morning over the 48 week treatment period.
11040320|NCT01254045|BG000|Baseline|All Study Participants|Includes groups randomized to one of six different sequences of three interventions (placebo, oxytocin 24IU, oxytocin 48IU).
11040321|NCT01254045|FG000|Participant Flow|Placebo 48IU, Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
11348917|NCT04126174|OG001|Outcome|Manual LRI|"Eyes will be treated with arcuate incisions completed manually with a blade.~Manual LRI: Manual LRI"
11348918|NCT04126174|EG000|Reported Event|Femtosecond Limbal Relaxing Incision (LRI)|"Eyes will be treated with arcuate incisions from a femtosecond laser system.~femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system."
11040322|NCT01254045|FG001|Participant Flow|Oxytocin 24IU/Placebo 24IU, Placebo 48IU, Oxytocin 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
11040323|NCT01254045|FG002|Participant Flow|Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
11040324|NCT01254045|FG003|Participant Flow|Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
11040325|NCT01254045|FG004|Participant Flow|Oxytocin 48IU, Placebo 48IU, Oxytocin 24IU/Placebo 24IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles ; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
11040326|NCT01254045|FG005|Participant Flow|Placebo 48IU, Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
11040327|NCT01254045|OG000|Outcome|Placebo|placebo (48IU)
11040328|NCT01254045|OG001|Outcome|Oxytocin 24IU/Placebo 24IU|24 international units of intranasal oxytocin and 24 international units of placebo
11040329|NCT01254045|OG002|Outcome|48IU OT|48 international units of intranasal oxytocin
11040330|NCT01254045|OG000|Outcome|Placebo|placebo (48 IU)
11040331|NCT01254045|OG001|Outcome|24IU OT|24 international units of intranasal oxytocin and 24 IU of placebo
11040332|NCT01254045|EG000|Reported Event|Intervention: Placebo 48IU|Two participants received placebo 48IU at baseline. Three participants received placebo 48IU at Time 2. Three participants received placebo 48IU at Time 3. This study is a cross-over design.
11040333|NCT01254045|EG001|Reported Event|Intervention: Oxytocin 24IU/Placebo 24IU|Three participants received Oxytocin 24IU/Placebo 24IU at baseline. Three participants received Oxytocin 24IU/Placebo 24IU at Time 2. Two participants received Oxytocin 24IU/Placebo 24IU at Time 3. This study is a cross-over design.
11040334|NCT01254045|EG002|Reported Event|Intervention: Oxytocin 48IU|Three participants received Oxytocin 48IU at baseline. Two participants received Oxytocin 48IU at Time 2. Three participants received Oxytocin 48IU at Time 3. This study is a cross-over design.
11040335|NCT01254188|BG000|Baseline|Nilotinib|Nilotinib 300 mg BID
11040336|NCT01254188|FG000|Participant Flow|Nilotinib|Nilotinib 300 mg BID
11040337|NCT01254188|OG000|Outcome|Nilotinib|Nilotinib 300 mg BID
11040338|NCT01254188|EG000|Reported Event|Nilotinib|Nilotinib 300 mg BID
11040339|NCT01254214|BG000|Baseline|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
11040340|NCT01254214|BG001|Baseline|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
11040341|NCT01254214|BG002|Baseline|Total|Total of all reporting groups
11040342|NCT01254214|FG000|Participant Flow|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
11040343|NCT01254214|FG001|Participant Flow|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
11040344|NCT01254214|OG000|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
11040345|NCT01254214|OG001|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
11040346|NCT01254214|EG000|Reported Event|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
11040347|NCT01254214|EG001|Reported Event|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
10887266|NCT00499603|FG000|Participant Flow|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
11040348|NCT01254227|BG000|Baseline|All Participants|Participants received an initial combined dose of Deferasirox (DFX) 20 mg/kg/day every day and Deferoxamine (DFO) 40 mg/kg/day (DFO: 5 days/week for at least 8 hours/day). Deferasirox was increased to 30 mg/kg/day every day at Month 1 Further dose increases upto 40 mg/kg/day every day at Month 6 visit. Participants could be switched from the Deferasirox - Deferoxamine (DFX - DFO) combination to Deferasirox monotherapy at the highest tolerable dose (30-40 mg/kg/day) at any time point after 6 months.
11040349|NCT01254227|FG000|Participant Flow|All Participants|Participants received an initial combined dose of Deferasirox (DFX) 20 Milligrams per Kilogram per day (mg/kg/day) every day and Deferoxamine (DFO) 40 mg/kg/day (DFO: 5 days/week for at least 8 hours/day). Deferasirox was increased to 30 mg/kg/day every day at Month 1 Further dose increases upto 40 mg/kg/day every day at Month 6 visit. Participants could be switched from the Deferasirox - Deferoxamine (DFX - DFO) combination to Deferasirox monotherapy at the highest tolerable dose (30-40 mg/kg/day) at any time point after 6 months.
11040350|NCT01254227|OG000|Outcome|All Participants|Participants received an initial combined dose of Deferasirox (DFX) 20 mg/kg/day every day and Deferoxamine (DFO) 40 mg/kg/day (DFO: 5 days/week for at least 8 hours/day). Deferasirox was increased to 30 mg/kg/day every day at Month 1 Further dose increases upto 40 mg/kg/day every day at Month 6 visit. Participants could be switched from the Deferasirox - Deferoxamine (DFX - DFO) combination to Deferasirox monotherapy at the highest tolerable dose (30-40 mg/kg/day) at any time point after 6 months.
11040351|NCT01254227|EG000|Reported Event|All Participants|Participants received an initial combined dose of Deferasirox (DFX) 20 mg/kg/day every day and Deferoxamine (DFO) 40 mg/kg/day (DFO: 5 days/week for at least 8 hours/day). Deferasirox was increased to 30 mg/kg/day every day at Month 1 Further dose increases upto 40 mg/kg/day every day at Month 6 visit. Participants could be switched from the Deferasirox - Deferoxamine (DFX - DFO) combination to Deferasirox monotherapy at the highest tolerable dose (30-40 mg/kg/day) at any time point after 6 months.
11040352|NCT01254292|BG000|Baseline|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
11040353|NCT01254292|BG001|Baseline|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
11040354|NCT01254292|BG002|Baseline|Total|Total of all reporting groups
11040355|NCT01254292|FG000|Participant Flow|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
11040356|NCT01254292|FG001|Participant Flow|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
11040357|NCT01254292|OG000|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
11040358|NCT01254292|OG001|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
11040359|NCT01254292|OG000|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
11040360|NCT01254292|EG000|Reported Event|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
11040361|NCT01254292|EG001|Reported Event|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
11040362|NCT01254305|BG000|Baseline|Placebo|"Matching placebo capsules, oral administration~Placebo : Matching placebo capsules, oral administration, once daily dosing"
11040363|NCT01254305|BG001|Baseline|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
11348919|NCT04126174|EG001|Reported Event|Manual LRI|"Eyes will be treated with arcuate incisions completed manually with a blade.~Manual LRI: Manual LRI"
10887088|NCT00498615|OG000|Outcome|Fasudil 80 mg|"Time to recover 70% of baseline skin temperature after cold challenge done 2 hrs after dose.~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
11040364|NCT01254305|BG002|Baseline|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
11040365|NCT01254305|BG003|Baseline|Total|Total of all reporting groups
11040366|NCT01254305|FG000|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing.
11040367|NCT01254305|FG001|Participant Flow|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.
11040368|NCT01254305|FG002|Participant Flow|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
11040369|NCT01254305|OG000|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
11040370|NCT01254305|OG001|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks
11040371|NCT01254305|OG002|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
11040372|NCT01254305|OG000|Outcome|Placebo|Dose matched placebo capsules, oral administration for 8 weeks.
11040373|NCT01254305|OG001|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks
11040374|NCT01254305|OG001|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks.
11040375|NCT01254305|EG000|Reported Event|Placebo|"Matching placebo capsules, oral administration~Placebo : Matching placebo capsules, oral administration, once daily dosing"
11040376|NCT01254305|EG001|Reported Event|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
11040377|NCT01254305|EG002|Reported Event|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
11040378|NCT01254318|BG000|Baseline|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation.
11040379|NCT01254318|FG000|Participant Flow|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
11040380|NCT01254318|OG000|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
11040381|NCT01254318|EG000|Reported Event|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
11040382|NCT01254331|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
11040383|NCT01254331|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the European League Against Rheumatism (EULAR) category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
11040384|NCT01254331|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
11040385|NCT01254331|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
11040386|NCT01254344|BG000|Baseline|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
11040387|NCT01254344|BG001|Baseline|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
11040388|NCT01254344|BG002|Baseline|Total|Total of all reporting groups
11040389|NCT01254344|FG000|Participant Flow|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
11040390|NCT01254344|FG001|Participant Flow|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
11040391|NCT01254344|OG000|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
11040392|NCT01254344|OG001|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
11040393|NCT01254344|EG000|Reported Event|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
11040394|NCT01254344|EG001|Reported Event|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
11040395|NCT01254396|BG000|Baseline|Entire Study Population|Includes groups randomized to receive sildenafil 50 mg ODT under fasted condition first and sildenafil 50 mg ODT under fed condition first.
11040396|NCT01254396|FG000|Participant Flow|Sildenafil Fasted First, Then Sildenafil Fed|Single oral dose of sildenafil 50 milligram (mg) orally disintegrating tablet (ODT) under fasted condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fed condition in second intervention period. A washout period of at least 1 day was maintained between each period.
11040397|NCT01254396|FG001|Participant Flow|Sildenafil Fed First, Then Sildenafil Fasted|Single oral dose of sildenafil 50 mg ODT under fed condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fasted condition in second intervention period. A washout period of at least 1 day was maintained between each period.
11040398|NCT01254396|OG000|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
11040399|NCT01254396|OG001|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
11040400|NCT01254396|EG000|Reported Event|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
11040401|NCT01254396|EG001|Reported Event|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
11040402|NCT01254552|BG000|Baseline|All Included Patients|All patients included in the study.
11040403|NCT01254552|FG000|Participant Flow|Dotarem and Xenetix 350|All patients were planned to undergo a MRI examination with Dotarem and a myocardial CCTA examination with Xenetix 350 to evaluate his/her coronary and cardiac status.
11040404|NCT01254552|OG000|Outcome|Intention To Treat Population|All patients with a valid MRI and CCTA examinations.
11040405|NCT01254552|OG000|Outcome|Patients Without Occult Myocardial Scar|Patients without Occult Myocardial Scar on cardiac MRI
11040406|NCT01254552|OG001|Outcome|Patients With at Least One Occult Myocardial Scar|Patients with at least one Occult Myocardial Scar on cardiac MRI
11040407|NCT01254552|EG000|Reported Event|Between Dotarem and Xenetix 350 Injection|Adverse events that occurred after Dotarem injection (MRI examination) and before Xenetix 350 injection (CCTA examination)
11040408|NCT01254552|EG001|Reported Event|During Xenetix 350 Injection|Adverse events that occurred during injection of Xenetix 350 (CCTA examination)
11040409|NCT01254552|EG002|Reported Event|After Xenetix 350 Injection|Adverse events that occurred after the injection of Xenetix 350 (CCTA examination)
11040410|NCT01254565|BG000|Baseline|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
11040411|NCT01254565|BG001|Baseline|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
11040412|NCT01254565|BG002|Baseline|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040413|NCT01254565|BG003|Baseline|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040414|NCT01254565|BG004|Baseline|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040415|NCT01254565|BG005|Baseline|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040416|NCT01254565|BG006|Baseline|Total|Total of all reporting groups
11040417|NCT01254565|FG000|Participant Flow|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
11040418|NCT01254565|FG001|Participant Flow|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
11040419|NCT01254565|FG002|Participant Flow|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040420|NCT01254565|FG003|Participant Flow|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040421|NCT01254565|FG004|Participant Flow|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040422|NCT01254565|FG005|Participant Flow|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040423|NCT01254565|OG000|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
11040424|NCT01254565|OG001|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
11040425|NCT01254565|OG002|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040426|NCT01254565|OG003|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040427|NCT01254565|OG004|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040428|NCT01254565|OG005|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040429|NCT01254565|EG000|Reported Event|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
11040430|NCT01254565|EG001|Reported Event|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
11040431|NCT01254565|EG002|Reported Event|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11348920|NCT04134429|BG000|Baseline|Everion®|"The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.~Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data."
10887307|NCT00499681|FG000|Participant Flow|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
11040432|NCT01254565|EG003|Reported Event|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040433|NCT01254565|EG004|Reported Event|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040434|NCT01254565|EG005|Reported Event|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
11040435|NCT01254604|BG000|Baseline|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
11040436|NCT01254604|BG001|Baseline|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
11040437|NCT01254604|BG002|Baseline|Total|Total of all reporting groups
11040438|NCT01254604|FG000|Participant Flow|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
11040439|NCT01254604|FG001|Participant Flow|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
11040440|NCT01254604|OG000|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
11040441|NCT01254604|OG001|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
11040442|NCT01254604|EG000|Reported Event|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
11040443|NCT01254604|EG001|Reported Event|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
11040444|NCT01254630|BG000|Baseline|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040445|NCT01254630|BG001|Baseline|V212-HM|Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040446|NCT01254630|BG002|Baseline|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040447|NCT01254630|BG003|Baseline|Placebo-HM|Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040448|NCT01254630|BG004|Baseline|Total|Total of all reporting groups
11040449|NCT01254630|FG000|Participant Flow|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040450|NCT01254630|FG001|Participant Flow|V212-HM|Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040451|NCT01254630|FG002|Participant Flow|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040452|NCT01254630|FG003|Participant Flow|Placebo-HM|Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040453|NCT01254630|OG000|Outcome|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040454|NCT01254630|OG001|Outcome|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040455|NCT01254630|EG000|Reported Event|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040456|NCT01254630|EG001|Reported Event|V212-HM|Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040457|NCT01254630|EG002|Reported Event|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040458|NCT01254630|EG003|Reported Event|Placebo-HM|Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
11040459|NCT01254643|BG000|Baseline|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
11040460|NCT01254643|FG000|Participant Flow|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
11040461|NCT01254643|OG000|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
11040462|NCT01254643|EG000|Reported Event|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
11040463|NCT01254656|BG000|Baseline|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040464|NCT01254656|BG001|Baseline|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040465|NCT01254656|BG002|Baseline|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040466|NCT01254656|BG003|Baseline|Total|Total of all reporting groups
11040467|NCT01254656|FG000|Participant Flow|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040468|NCT01254656|FG001|Participant Flow|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040469|NCT01254656|FG002|Participant Flow|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040470|NCT01254656|OG000|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040471|NCT01254656|OG001|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040472|NCT01254656|OG002|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040473|NCT01254656|EG000|Reported Event|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040474|NCT01254656|EG001|Reported Event|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040475|NCT01254656|EG002|Reported Event|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
11040476|NCT01254669|BG000|Baseline|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
11040477|NCT01254669|BG001|Baseline|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one for immigration status .
11040478|NCT01254669|BG002|Baseline|Total|Total of all reporting groups
11040479|NCT01254669|FG000|Participant Flow|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve Human Papilloma Virus (HPV) vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV vaccine information sheet usually given to all patients prior to vaccination. Control mothers met once with the research assistant to collect demographic characteristics, HPV knowledge, and vaccine status of the daughter on the day of visit. No Brief Negotiated Intervention (BNI) counseling was provided."
11040480|NCT01254669|FG001|Participant Flow|Brief Negotiated Inteview (BNI) Intervention|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2) and one dropped out for fear information from study will affect her immigration status"
11040481|NCT01254669|OG000|Outcome|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), received the standard of care handout given to patients on the vaccine they will be getting that day. three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
11040482|NCT01254669|OG001|Outcome|BNI/Intervention|Intervention was administered to 100 African-American and Haitian mothers over 10-20 minutes prior to seeing the health provider if the daughter had never received the HPV vaccine, or after seeing the health provider if the daughter did not received the vaccine during the visit.
11040483|NCT01254669|OG000|Outcome|BNI Post-educational Intervention Group|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Post-educational interventional assessment of HPV knowledge ranges from 0(minimal knowledge) to 12 (maximal knowledge)"
11040484|NCT01254669|OG001|Outcome|Control Group|Did not receive any BNI intervention on the pre and post measure
11040485|NCT01254669|EG000|Reported Event|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
11040486|NCT01254669|EG001|Reported Event|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). . Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one due to fear of information affecting immigration status.
11040487|NCT01254721|BG000|Baseline|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
11040488|NCT01254721|BG001|Baseline|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
11040489|NCT01254721|BG002|Baseline|Total|Total of all reporting groups
11040490|NCT01254721|FG000|Participant Flow|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
11040491|NCT01254721|FG001|Participant Flow|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
11040492|NCT01254721|OG000|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
11040493|NCT01254721|OG001|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
11040494|NCT01254721|EG000|Reported Event|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
11040495|NCT01254721|EG001|Reported Event|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
11040496|NCT01254747|BG000|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040497|NCT01254747|BG001|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040498|NCT01254747|BG002|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040499|NCT01254747|BG003|Baseline|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040500|NCT01254747|BG004|Baseline|Total|Total of all reporting groups
11040501|NCT01254747|FG000|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040502|NCT01254747|FG001|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040503|NCT01254747|FG002|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040504|NCT01254747|FG003|Participant Flow|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040505|NCT01254747|OG000|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040506|NCT01254747|OG001|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040507|NCT01254747|OG002|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040508|NCT01254747|OG003|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040509|NCT01254747|EG000|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040510|NCT01254747|EG001|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040511|NCT01254747|EG002|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040512|NCT01254747|EG003|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
11040513|NCT01254760|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
11040514|NCT01254760|FG000|Participant Flow|Investigational Multifocal / Commercial Multifocal|Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
11040515|NCT01254760|FG001|Participant Flow|Commercial Multifocal / Investigational Multifocal|Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
11040516|NCT01254760|OG000|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
11040517|NCT01254760|OG001|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
11040518|NCT01254760|OG001|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in bilaterally on a daily wear, daily disposable basis for 5 days
11040519|NCT01254760|EG000|Reported Event|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
11040520|NCT01254760|EG001|Reported Event|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
11040521|NCT01254851|BG000|Baseline|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
11040522|NCT01254851|BG001|Baseline|Usual Care|routine post-operative ambulation
11040523|NCT01254851|BG002|Baseline|Total|Total of all reporting groups
11040524|NCT01254851|FG000|Participant Flow|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
11040525|NCT01254851|FG001|Participant Flow|Usual Care|routine post-operative ambulation
11040526|NCT01254851|OG000|Outcome|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
11040527|NCT01254851|OG001|Outcome|Usual Care|routine post-operative ambulation
11040528|NCT01254851|EG000|Reported Event|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
11040529|NCT01254851|EG001|Reported Event|Usual Care|routine post-operative ambulation
11040530|NCT01254877|BG000|Baseline|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
11040531|NCT01254877|BG001|Baseline|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
11040532|NCT01254877|BG002|Baseline|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
11040533|NCT01254877|BG003|Baseline|Total|Total of all reporting groups
11040534|NCT01254877|FG000|Participant Flow|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
11040535|NCT01254877|FG001|Participant Flow|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
11040536|NCT01254877|FG002|Participant Flow|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
11040537|NCT01254877|OG000|Outcome|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
11040538|NCT01254877|OG001|Outcome|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
11040539|NCT01254877|OG002|Outcome|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
11040540|NCT01254877|EG000|Reported Event|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
11040541|NCT01254877|EG001|Reported Event|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
11040542|NCT01254877|EG002|Reported Event|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
11040543|NCT01254890|BG000|Baseline|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
11040544|NCT01254890|BG001|Baseline|Phase II: Azacitidine + 400 Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
11040545|NCT01254890|BG002|Baseline|Total|Total of all reporting groups
11040546|NCT01254890|FG000|Participant Flow|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
11226196|NCT02372383|FG000|Participant Flow|Healthy Controls (Fasting Only)|"Healthy subjects without CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug"
11226197|NCT02372383|FG001|Participant Flow|CF Patients, Fasting, Then Food|"Fasting for 1 day, then washout for 2 weeks, then Food for 1 day.~Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg) Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg) Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg) Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Experimental: Food/Enzymes Subjects with CF will be given the antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase).~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg) Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg) Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg) Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose"
11226198|NCT02372383|FG002|Participant Flow|CF Patients, Food Then Fasting|"Food for 1 day, then washout for 2 weeks, then Fasting for 1 day.~Subjects with CF will be given the antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase).~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg) Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg) Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg) Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg) Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg) Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg) Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose"
11226199|NCT02372383|OG000|Outcome|Healthy Controls|"Healthy subjects without CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug"
11226200|NCT02372383|OG001|Outcome|CF Fasting|"Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug~CF subjects will then cross-over following at least a 2 week washout time point and and be given the same dose of the 3 antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase)."
11226201|NCT02372383|OG002|Outcome|CF Food|"Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug~CF subjects will then cross-over following at least a 2 week washout time point and and be given the same dose of the 3 antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase)."
11226202|NCT02372383|OG001|Outcome|CF Patients, Fasting|"Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug~CF subjects will then cross-over following at least a 2 week washout time point and and be given the same dose of the 3 antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase)."
11226203|NCT02372383|OG002|Outcome|CF Patients, Food|"Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug~CF subjects will then cross-over following at least a 2 week washout time point and and be given the same dose of the 3 antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase)."
10848925|NCT00292591|OG001|Outcome|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
10848926|NCT00292591|OG002|Outcome|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11040547|NCT01254890|FG001|Participant Flow|Phase II: Azacitidine + 400 mg Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
11040548|NCT01254890|OG000|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
11040549|NCT01254890|EG000|Reported Event|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
11040550|NCT01254890|EG001|Reported Event|Phase II: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 400 mg orally twice a day for 28 Day cycle.
11040551|NCT01255137|BG000|Baseline|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
11040552|NCT01255137|FG000|Participant Flow|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
11040553|NCT01255137|OG000|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
11040554|NCT01255137|EG000|Reported Event|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
11040555|NCT01255163|BG000|Baseline|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
11040556|NCT01255163|BG001|Baseline|Placebo|Placebo SC twice daily
11040557|NCT01255163|BG002|Baseline|Total|Total of all reporting groups
11040558|NCT01255163|FG000|Participant Flow|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
11040559|NCT01255163|FG001|Participant Flow|Placebo|Placebo SC twice daily
11040560|NCT01255163|OG000|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
11040561|NCT01255163|OG001|Outcome|Placebo|Placebo SC twice daily
11040562|NCT01255163|OG000|Outcome|Exendin-4|"Exenatide 5 mcg or 10 mcg SC twice daily~Exendin-4 SC: Exenatide 5 mcg or 10 mcg SC twice daily"
11040563|NCT01255163|OG001|Outcome|Placebo|"Placebo SC twice daily~Placebo SC: Placebo SC twice daily"
11040564|NCT01255163|EG000|Reported Event|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
11040565|NCT01255163|EG001|Reported Event|Placebo|Placebo SC twice daily
11040566|NCT01255306|BG000|Baseline|NO IOP|Patients without raised IOP
11040567|NCT01255306|BG001|Baseline|RAISED IOP|Patients with raised IOP
11040568|NCT01255306|BG002|Baseline|Total|Total of all reporting groups
11040569|NCT01255306|FG000|Participant Flow|NO IOP|Patients without raised IOP
11040570|NCT01255306|FG001|Participant Flow|RAISED IOP|Patients with raised IOP
11040571|NCT01255306|OG000|Outcome|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
11040572|NCT01255306|OG001|Outcome|CONTROL EYES|Fellow eye of each patient
11040573|NCT01255306|OG000|Outcome|NO IOP|Patients without raised IOP
11040574|NCT01255306|OG001|Outcome|RAISED IOP|Patients with raised IOP
11040575|NCT01255306|OG002|Outcome|CONTROL|Fellow eye of each patient
11040576|NCT01255306|EG000|Reported Event|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
11040577|NCT01255306|EG001|Reported Event|CONTROL EYES|Fellow eye of each patient
11040578|NCT01255423|BG000|Baseline|Diclofenac Sodium Topical Gel 1%|
11040579|NCT01255423|BG001|Baseline|Placebo|
11040580|NCT01255423|BG002|Baseline|Total|Total of all reporting groups
11040581|NCT01255423|FG000|Participant Flow|Diclofenac Sodium Topical Gel 1%|
11040582|NCT01255423|FG001|Participant Flow|Placebo|
11040583|NCT01255423|OG000|Outcome|Diclofenac Sodium Topical Gel 1%|
11040584|NCT01255423|OG001|Outcome|Placebo|
11040585|NCT01255423|EG000|Reported Event|Diclofenac Sodium Topical Gel 1%|
11040586|NCT01255423|EG001|Reported Event|Placebo|
11040587|NCT01255436|BG000|Baseline|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
11040588|NCT01255436|BG001|Baseline|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
11040589|NCT01255436|BG002|Baseline|Total|Total of all reporting groups
11040590|NCT01255436|FG000|Participant Flow|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
11040591|NCT01255436|FG001|Participant Flow|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
11040592|NCT01255436|OG000|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
11040593|NCT01255436|OG001|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
11040594|NCT01255436|EG000|Reported Event|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
11040595|NCT01255436|EG001|Reported Event|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
11040596|NCT01255449|BG000|Baseline|Albuterol|All recruited subjects underwent an acute bronchodilation with albuterol following baseline pulmonary function measurements.
11040597|NCT01255449|FG000|Participant Flow|Albuterol|On each study day, all lung function measurements were taken before and 30 min after inhaling four consecutive albuterol doses of 100 mcg each, through a valved-holding chamber. Lung diffusing capacity for carbon monoxide was measured only after bronchodilator inhalation.
11040598|NCT01255449|OG000|Outcome|Airway Distensibility With Lung Inflation After HSCT|Changes in airway conductance at 5 Hz (Grs5) were related to changes in lung volume (DeltaGrs5/DeltaVL) to estimate airway distensibility
11040599|NCT01255449|OG000|Outcome|Post-HSCT Changes in Lung Tissue Density|In eight out of 26 patients, a quantitative CT scan analysis was conducted to measure changes in lung tissue density
11040600|NCT01255449|EG000|Reported Event|Albuterol|All subjects underwent an acute bronchodilation with albuterol by inhaling four consecutive doses (100 mcg each)of the drug through a valved-holding chamber
11040601|NCT01255592|BG000|Baseline|AZD5069|AZD5069 80 mg bd
11040602|NCT01255592|BG001|Baseline|Placebo|Placebo bd
11040603|NCT01255592|BG002|Baseline|Total|Total of all reporting groups
11040604|NCT01255592|FG000|Participant Flow|AZD5069|AZD5069 80 mg bd
11040605|NCT01255592|FG001|Participant Flow|Placebo|Placebo for AZD5069, bd
11040606|NCT01255592|OG000|Outcome|AZD5069|AZD5069 80 mg bd
11040607|NCT01255592|OG001|Outcome|Placebo|Placebo bd
11040608|NCT01255592|OG001|Outcome|Placebo|Placebo for AZD5069, bd
11040609|NCT01255592|EG000|Reported Event|AZD5069|80 mg bd
11040610|NCT01255592|EG001|Reported Event|Placebo|Placebo for AZD5069 bd
11040611|NCT01255631|BG000|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
11040612|NCT01255631|BG001|Baseline|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
11040613|NCT01255631|BG002|Baseline|Total|Total of all reporting groups
11040614|NCT01255631|FG000|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
11040615|NCT01255631|FG001|Participant Flow|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
11040616|NCT01255631|OG000|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
10887267|NCT00499603|FG001|Participant Flow|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
11040617|NCT01255631|OG001|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
11040618|NCT01255631|EG000|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
11040619|NCT01255631|EG001|Reported Event|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
11040620|NCT01255670|BG000|Baseline|Penicillin and Metronidazole|"After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess.~Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days."
11040621|NCT01255670|BG001|Baseline|Penicillin and Placebo|"After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess.~Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days."
11040622|NCT01255670|BG002|Baseline|Total|Total of all reporting groups
11040623|NCT01255670|FG000|Participant Flow|Penicillin and Metronidazole|"After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess.~Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days."
11040624|NCT01255670|FG001|Participant Flow|Penicillin and Placebo|"After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess.~Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days."
11040625|NCT01255670|OG000|Outcome|Penicillin and Metronidazole|"After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess.~Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days."
11040626|NCT01255670|OG001|Outcome|Penicillin and Placebo|"After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess.~Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days."
11040627|NCT01255670|EG000|Reported Event|Penicillin and Metronidazole|"After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess.~Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days."
11226204|NCT02372383|EG000|Reported Event|Healthy Controls|"Healthy subjects without CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug"
11226205|NCT02372383|EG001|Reported Event|CF Patients, Fasting|"Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug~CF subjects will then cross-over following at least a 2 week washout time point and and be given the same dose of the 3 antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase)."
11226206|NCT02372383|EG002|Reported Event|CF Patients, Food|"Subjects with CF will be given the antimycobacterial drugs in the fasting state, without supplemental pancreatic enzymes~Rifampin 10mg/kg oral once daily (max 600mg, round to closest 150mg)~Ethambutol 15mg/kg oral once daily (max 2500mg, round to nearest 100mg)~Azithromycin 10mg/kg oral once daily (max 500mg, rounded to the nearest 250mg)~Blood will be drawn at time points 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose~Ethambutol: Anti-mycobacterial oral drug~Rifampin: Anti-mycobacterial oral drug~Azithromycin: Anti-mycobacterial oral drug~CF subjects will then cross-over following at least a 2 week washout time point and and be given the same dose of the 3 antimycobacterial drugs with a standardized meal plus a typical meal-dose of pancreatic enzymes (Pancrelipase)."
11226207|NCT02372396|BG000|Baseline|CBCT-Vet|"CBCT-Vet delivered in 10 1.5-hour group treatment sessions.~CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness."
11226208|NCT02372396|BG001|Baseline|Veteran.Calm|"Veteran.calm delivered in 10 1.5-hour group treatment sessions.~Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises)."
11226209|NCT02372396|BG002|Baseline|Total|Total of all reporting groups
11226210|NCT02372396|FG000|Participant Flow|CBCT-Vet|"Cognitively Based Compassion Training, Veteran Version (CBCT-Vet) delivered in 10 1.5-hour group treatment sessions.~CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness."
11226211|NCT02372396|FG001|Participant Flow|Veteran.Calm|"Veteran.calm delivered in 10 1.5-hour group treatment sessions.~Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises)."
11226212|NCT02372396|OG000|Outcome|CBCT-Vet|"CBCT-Vet delivered in 10 1.5-hour group treatment sessions.~CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness."
11226213|NCT02372396|OG001|Outcome|Veteran.Calm|"Veteran.calm delivered in 10 1.5-hour group treatment sessions.~Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises)."
11226214|NCT02372396|EG000|Reported Event|CBCT-Vet|"CBCT-Vet delivered in 10 1.5-hour group treatment sessions.~CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness."
11226215|NCT02372396|EG001|Reported Event|Veteran.Calm|"Veteran.calm delivered in 10 1.5-hour group treatment sessions.~Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises)."
11226216|NCT02372682|BG000|Baseline|Test|"Any pediatric patient (0-18 years of age) with known liver disease in whom a liver biopsy is to be performed as standard of care to assess the degree of fibrosis will also undergo an abdominal ultrasound to evaluate the liver.~Underlying diagnoses include but are not limited to biliary atresia, congenital fibrosis-cholestasis, Alagille syndrome, Caroli's disease, choledochal cyst, alpha-1-antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC), viral hepatitis, glycogenosis, fructosemia, Wilson disease, cystic fibrosis, autosomal recessive polycystic kidney disease (ARPCKD), mesenterico-caval shunt, post liver transplant, and nonalcoholic steatohepatitis (NASH).~Shear wave sonoelastography: Sonoelastography is to be performed on the liver."
11226217|NCT02372682|BG001|Baseline|Control|"Any pediatric patient (0-18 years of age) undergoing evaluation with an abdominal ultrasound as standard of care for evaluation for a diagnosis other than liver disease and in whom the US shows a normal liver, gallbladder, pancreas, spleen, and biliary tree will then be asked to enroll in the research study by undergoing shear wave elastography.~Shear wave sonoelastography: Sonoelastography is to be performed on the liver."
11040628|NCT01255670|EG001|Reported Event|Penicillin and Placebo|"After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess.~Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days."
11040629|NCT01255722|BG000|Baseline|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
11040630|NCT01255722|BG001|Baseline|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
11040631|NCT01255722|BG002|Baseline|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
11040632|NCT01255722|BG003|Baseline|Total|Total of all reporting groups
11040633|NCT01255722|FG000|Participant Flow|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
11040634|NCT01255722|FG001|Participant Flow|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
11040635|NCT01255722|FG002|Participant Flow|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
11040636|NCT01255722|OG000|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
11040637|NCT01255722|OG001|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
11040638|NCT01255722|OG002|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
11040639|NCT01255722|OG001|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before coronary CT angiography
11040640|NCT01255722|EG000|Reported Event|Iobitridol|"Patients were IV injected with a single dose of iobitridol before a coronary CT angiography~iobitridol: single IV injection"
11040641|NCT01255722|EG001|Reported Event|Iopromide|"Patients were IV injected with a single dose of iopromide before a coronary CT angiography~iopromide: Single IV injection"
11040642|NCT01255722|EG002|Reported Event|Iomeprol|"Patients were IV injected with a single dose of iomeprol before a coronary CT angiography~iomeprol: Single IV injection"
11348921|NCT04134429|FG000|Participant Flow|Everion®|"The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.~Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data."
11066536|NCT01392859|BG000|Baseline|Overall Study|"211 participants enrolled in overall study including laser doppler testing. Only 28 participants continued to subgroups below:~Group 1: Initial Treatment: Levocetirizine(LCT) will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.~Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.~Group 2: Initial Treatment: Placebo will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.~Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD."
11066537|NCT01392859|FG000|Participant Flow|Initial Treatment: Levocetirizine First, Then Placebo|"Only a small sub-set of the overall study participants were included in this analysis.~Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.~These participants also went through the laser doppler portion prior to the crossover portion of the study.~Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD."
11066538|NCT01392859|FG001|Participant Flow|Initial Treatment: Placebo First, Then Levocetirizine|"Only a small sub-set of the overall study participants were included in this analysis.~Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.~These participants also went through the laser doppler portion prior to the crossover portion of the study.~Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD."
11066539|NCT01392859|FG002|Participant Flow|Laser Doppler Portion Only|Participants who completed Only Laser Doppler portion of the study.
11066540|NCT01392859|OG000|Outcome|Overall Study|Comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine.
11066541|NCT01392859|EG000|Reported Event|Initial Treatment: Levocetirizine First, Then Placebo|"Only a small sub-set of the overall study participants were included in this analysis.~Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.~Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.~These participants also went through the laser doppler portion prior to the crossover portion of the study.~Note: Adverse Events (AE) were recorded by arm therefore AE's cannot be provided for each intervention separately. This data is no longer available to retrospectively separate AE's out by intervention."
11226218|NCT02372682|BG002|Baseline|Total|Total of all reporting groups
11040643|NCT01255761|BG000|Baseline|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
11040644|NCT01255761|BG001|Baseline|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
11040645|NCT01255761|BG002|Baseline|Total|Total of all reporting groups
11040646|NCT01255761|FG000|Participant Flow|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
11040647|NCT01255761|FG001|Participant Flow|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
11040648|NCT01255761|OG000|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
11040649|NCT01255761|OG001|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
11226219|NCT02372682|FG000|Participant Flow|Test|"Any pediatric patient (0-18 years of age) with known liver disease in whom a liver biopsy is to be performed as standard of care to assess the degree of fibrosis will also undergo an abdominal ultrasound to evaluate the liver.~Underlying diagnoses include but are not limited to biliary atresia, congenital fibrosis-cholestasis, Alagille syndrome, Caroli's disease, choledochal cyst, alpha-1-antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC), viral hepatitis, glycogenosis, fructosemia, Wilson disease, cystic fibrosis, autosomal recessive polycystic kidney disease (ARPCKD), mesenterico-caval shunt, post liver transplant, and nonalcoholic steatohepatitis (NASH).~Shear wave sonoelastography: Sonoelastography is to be performed on the liver."
11226220|NCT02372682|FG001|Participant Flow|Control|"Any pediatric patient (0-18 years of age) undergoing evaluation with an abdominal ultrasound as standard of care for evaluation for a diagnosis other than liver disease and in whom the US shows a normal liver, gallbladder, pancreas, spleen, and biliary tree will then be asked to enroll in the research study by undergoing shear wave elastography.~Shear wave sonoelastography: Sonoelastography is to be performed on the liver."
11226221|NCT02372682|OG000|Outcome|Controls+METAVIR 0|Controls+METAVIR 0 (no portal fibrosis)
11226222|NCT02372682|OG001|Outcome|METAVIR F1|portal fibrosis without septa
11226223|NCT02372682|OG002|Outcome|METAVIR F2|portal fibrosis with few septa
10848927|NCT00292591|EG000|Reported Event|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11040650|NCT01255761|EG000|Reported Event|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
11040651|NCT01255761|EG001|Reported Event|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
11040652|NCT01255787|BG000|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
11040653|NCT01255787|BG001|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
11040654|NCT01255787|BG002|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
11040655|NCT01255787|BG003|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
11040656|NCT01255787|BG004|Baseline|Total|Total of all reporting groups
11040657|NCT01255787|FG000|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
11040658|NCT01255787|FG001|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
11040659|NCT01255787|FG002|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
11226224|NCT02372682|OG003|Outcome|METAVIR F3|septal fibrosis without cirrhosis
11226225|NCT02372682|OG000|Outcome|Control + Ishak 0|Control + Ishak 0 (no fibrosis)
11226226|NCT02372682|OG001|Outcome|Ishak 1|Fibrous expansion of some portal areas, with or without short fibrous septa
11226227|NCT02372682|OG002|Outcome|Ishak 2|Fibrous expansion of most portal areas, with or without short fibrous septa
11226228|NCT02372682|OG003|Outcome|Ishak 3|Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging
11226229|NCT02372682|OG004|Outcome|Ishak 4|Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)
11226832|NCT02378402|FG002|Participant Flow|Control Group|"Age- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11040660|NCT01255787|FG003|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
11040661|NCT01255787|OG000|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
11040662|NCT01255787|OG001|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
11040663|NCT01255787|OG002|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
11040664|NCT01255787|OG003|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
11040665|NCT01255787|EG000|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
11040666|NCT01255787|EG001|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
11040667|NCT01255787|EG002|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
11040668|NCT01255787|EG003|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
11040669|NCT01255865|BG000|Baseline|Age1|Age group 0 up to 1 month
11040670|NCT01255865|BG001|Baseline|Age2|Age group from 1 month to 3 months
11040671|NCT01255865|BG002|Baseline|Age3|Age group from 3 months to 1 year
11040672|NCT01255865|BG003|Baseline|Age4|Age group from older than 1y and younger than 5 years
11040673|NCT01255865|BG004|Baseline|Age5|Age group from older than 5y and younger than 12 years
11040674|NCT01255865|BG005|Baseline|Age6|Age group from older than 12 years and younger than 21 years
11040675|NCT01255865|BG006|Baseline|Age7|Age group older than 21 years
11040676|NCT01255865|BG007|Baseline|Total|Total of all reporting groups
11040677|NCT01255865|FG000|Participant Flow|Age 1|Age group 0 up to 1 month
11226866|NCT02378714|FG000|Participant Flow|Standard Treatment + Placebo Varenicline|"Standard behavioral smoking cessation treatment plus placebo varenicline~Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11040678|NCT01255865|FG001|Participant Flow|Age 2|Age group from 1 month to 3 months
11040679|NCT01255865|FG002|Participant Flow|Age 3|Age group from 3 months to 1 year
11040680|NCT01255865|FG003|Participant Flow|Age 4|Age group from older than 1y and younger than 5 years
11040681|NCT01255865|FG004|Participant Flow|Age 5|Age group from older than 5y and younger than 12 years
11040682|NCT01255865|FG005|Participant Flow|Age 6|Age group from older than 12 years and younger than 21 years
11040683|NCT01255865|FG006|Participant Flow|Age 7|Age group older than 21 years
11040684|NCT01255865|OG000|Outcome|Age1|Age group 0 up to 1 month
11040685|NCT01255865|OG001|Outcome|Age2|Age group from 1 month to 3 months
11040686|NCT01255865|OG002|Outcome|Age3|Age group from 3 months to 1 year
11040687|NCT01255865|OG003|Outcome|Age4|Age group from older than 1y and younger than 5 years
11040688|NCT01255865|OG004|Outcome|Age5|Age group from older than 5y and younger than 12 years
11040689|NCT01255865|OG005|Outcome|Age6|Age group from older than 12 years and younger than 21 years
11040690|NCT01255865|OG006|Outcome|Age7|Age group older than 21 years
11040691|NCT01255865|EG000|Reported Event|Age1|Age group 0 up to 1 month
11040692|NCT01255865|EG001|Reported Event|Age2|Age group from 1 month to 3 months
11040693|NCT01255865|EG002|Reported Event|Age3|Age group from 3 months to 1 year
11040694|NCT01255865|EG003|Reported Event|Age4|Age group from older than 1y and younger than 5 years
11040695|NCT01255865|EG004|Reported Event|Age5|Age group from older than 5y and younger than 12 years
11040696|NCT01255865|EG005|Reported Event|Age6|Age group from older than 12 years and younger than 21 years
11040697|NCT01255865|EG006|Reported Event|Age7|Age group older than 21 years
11040698|NCT01255904|BG000|Baseline|Oral Placebo and Intransal Dexmedetomidine|
11040699|NCT01255904|BG001|Baseline|Oral Chloral Hydrate and Intranasal Placebo|
11040700|NCT01255904|BG002|Baseline|Total|Total of all reporting groups
11040701|NCT01255904|FG000|Participant Flow|Oral Placebo and Intransal Dexmedetomidine|Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).
11040702|NCT01255904|FG001|Participant Flow|Oral Chloral Hydrate and Intranasal Placebo|50 mg/kg oral chloral hydrate followed by intranasal placebo.
11040703|NCT01255904|OG000|Outcome|Oral Placebo and Intransal Dexmedetomidine|
11040704|NCT01255904|OG001|Outcome|Oral Chloral Hydrate and Intranasal Placebo|
11040705|NCT01255904|EG000|Reported Event|Oral Placebo and Intransal Dexmedetomidine|
11040706|NCT01255904|EG001|Reported Event|Oral Chloral Hydrate and Intranasal Placebo|
11040707|NCT01256008|BG000|Baseline|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
11040708|NCT01256008|BG001|Baseline|stage1 CBT|"The experimental group each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
11040709|NCT01256008|BG002|Baseline|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
11040710|NCT01256008|BG003|Baseline|Total|Total of all reporting groups
11040711|NCT01256008|FG000|Participant Flow|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
11040712|NCT01256008|FG001|Participant Flow|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
11040713|NCT01256008|FG002|Participant Flow|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
11040714|NCT01256008|OG000|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
11040715|NCT01256008|OG001|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
11040716|NCT01256008|OG002|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
11040717|NCT01256008|OG001|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
11040718|NCT01256008|OG002|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
11040719|NCT01256008|EG000|Reported Event|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
11040720|NCT01256008|EG001|Reported Event|stage1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
11040721|NCT01256008|EG002|Reported Event|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
11040722|NCT01256034|BG000|Baseline|Group A|preoperative immunonutrition
11040723|NCT01256034|BG001|Baseline|Group B|ordinary diet
11040724|NCT01256034|BG002|Baseline|Total|Total of all reporting groups
11040725|NCT01256034|FG000|Participant Flow|Group A|preoperative immunonutrition
11040726|NCT01256034|FG001|Participant Flow|Group B|ordinary diet
11040727|NCT01256034|OG000|Outcome|Group A|preoperative immunonutrition
11040728|NCT01256034|OG001|Outcome|Group B|ordinary diet
11040729|NCT01256034|EG000|Reported Event|Group A|preoperative immunonutrition
11040730|NCT01256034|EG001|Reported Event|Group B|ordinary diet
11040731|NCT01256060|BG000|Baseline|Intanasal Oxytocin|"A modified dose finding method was used to determine safety among four dose levels. Half the dose (0.2 IU/kg /dose) was the minimum dose and two intermediate doses were also evaluated (0.26 and 0.33 IU/kg / dose) Dose-finding escalations were done in groups of three patients.~Three patients were studied at the first dose level~If none of these patients experienced dose limiting toxicity, the dose was escalated.~If one patient experienced dose limiting toxicity, up to three more patients were accrued at the same level. (a) If none of these patients experienced dose limiting toxicity, the dose was escalated. (b) If one or more experienced dose-limiting toxicity, entry at that dose level would be stopped, the maximum tolerated dose exceeded, and dose escalation would be stopped. Up to three more patients would be treated at the next lower dose. If zero out of three patients experience dose limiting toxicity, an additional three patients were to be treated at that dose."
11040732|NCT01256060|FG000|Participant Flow|0.2 IU / kg|
11040733|NCT01256060|FG001|Participant Flow|0.26 IU / kg|
11226230|NCT02372682|EG000|Reported Event|Test|"Any pediatric patient (0-18 years of age) with known liver disease in whom a liver biopsy is to be performed as standard of care to assess the degree of fibrosis will also undergo an abdominal ultrasound to evaluate the liver.~Underlying diagnoses include but are not limited to biliary atresia, congenital fibrosis-cholestasis, Alagille syndrome, Caroli's disease, choledochal cyst, alpha-1-antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC), viral hepatitis, glycogenosis, fructosemia, Wilson disease, cystic fibrosis, autosomal recessive polycystic kidney disease (ARPCKD), mesenterico-caval shunt, post liver transplant, and nonalcoholic steatohepatitis (NASH).~Shear wave sonoelastography: Sonoelastography is to be performed on the liver."
11040734|NCT01256060|FG002|Participant Flow|0.33 IU / kg|
11040735|NCT01256060|FG003|Participant Flow|0.4 IU / kg|
11040736|NCT01256060|OG000|Outcome|Intanasal Oxytocin|Cohort 1 Dosage: 0.20 IU/kg - 3 participants Cohort 2 Dosage: 0.26 IU/kg - 3 participants Cohort 3 Dosage: 0.33 IU/kg - 3 participants Cohort 4 Dosage: 0.40 IU/kg - 6 participants
11040737|NCT01256060|OG000|Outcome|Intanasal Oxytocin|Number of Participants Experiencing a Serious Adverse Event
11040738|NCT01256060|OG000|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
11040739|NCT01256060|EG000|Reported Event|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin. Please note that the Adverse Events are not presented per dose level received, as this is not a dose-finding study, it is a modified maximum tolerated dose study. This means that a small number of participants were exposed to increasing dose levels to assess for Adverse Events. It is not meaningful to analyze adverse events by cohorts due to the extremely small sample size.
11040740|NCT01256164|BG000|Baseline|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
11040741|NCT01256164|BG001|Baseline|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
11040742|NCT01256164|BG002|Baseline|Total|Total of all reporting groups
11040743|NCT01256164|FG000|Participant Flow|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
11040744|NCT01256164|FG001|Participant Flow|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
11040745|NCT01256164|OG000|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
11040746|NCT01256164|OG001|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
11040747|NCT01256164|EG000|Reported Event|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
11040748|NCT01256164|EG001|Reported Event|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
11040749|NCT01256177|BG000|Baseline|Placebo|Placebo matching Quetiapine XR.
11040750|NCT01256177|BG001|Baseline|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
11040751|NCT01256177|BG002|Baseline|Total|Total of all reporting groups
11040752|NCT01256177|FG000|Participant Flow|Placebo|Placebo matching Quetiapine XR.
11040753|NCT01256177|FG001|Participant Flow|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
11040754|NCT01256177|OG000|Outcome|Placebo|Placebo matching Quetiapine XR.
11040755|NCT01256177|OG001|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
11040756|NCT01256177|EG000|Reported Event|PLACEBO|
11040757|NCT01256177|EG001|Reported Event|QUETIAPINE XR|
11040758|NCT01256190|BG000|Baseline|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
11040759|NCT01256190|BG001|Baseline|Gelatin Sponge|approved device for surgical bleeding
11040760|NCT01256190|BG002|Baseline|Total|Total of all reporting groups
11040761|NCT01256190|FG000|Participant Flow|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
11040762|NCT01256190|FG001|Participant Flow|Gelatin Sponge|approved device for surgical bleeding
11040763|NCT01256190|OG000|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
11040764|NCT01256190|OG001|Outcome|Gelatin Sponge|approved device for surgical bleeding
11040765|NCT01256190|EG000|Reported Event|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
11040766|NCT01256190|EG001|Reported Event|Gelatin Sponge|approved device for surgical bleeding
11040767|NCT01256294|BG000|Baseline|All Participants|"Period 1 (Days 1 through 14): Participants randomized to Sequence 1 took branded tacrolimus (Prograf) and participants randomized to Sequence 2 took generic tacrolimus (Sandoz).~Period 2 (Days 15 through 28): Participants randomized to Sequence 1 crossed over to treatment with generic tacrolimus and participants randomized to Sequence 2 crossed over to treatment with branded tacrolimus."
11040768|NCT01256294|FG000|Participant Flow|Sequence 1 - Branded Tacrolimus / Generic Tacrolimus|In Period 1 (Days 1 - 14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis).
11040769|NCT01256294|FG001|Participant Flow|Sequence 2 - Generic Tacrolimus / Branded Tacrolimus|In Period 1 (Days 1-14) participants received generic tacrolimus (Sandoz) orally twice a day and in Period 2 (Days 15-28) participants received branded tacrolimus (Prograf) orally twice a day. Participants received the same stable dosage of tacrolimus dose they had been taking prior to enrollment (on a milligram for milligram basis).
11040770|NCT01256294|OG000|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
11040771|NCT01256294|OG001|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
11040772|NCT01256294|EG000|Reported Event|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
11040773|NCT01256294|EG001|Reported Event|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
11040774|NCT01256385|BG000|Baseline|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
11040775|NCT01256385|BG001|Baseline|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
11040776|NCT01256385|BG002|Baseline|Total|Total of all reporting groups
11040777|NCT01256385|FG000|Participant Flow|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
11040778|NCT01256385|FG001|Participant Flow|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
11040779|NCT01256385|OG000|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
11040780|NCT01256385|OG001|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
11040781|NCT01256385|EG000|Reported Event|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
11040782|NCT01256385|EG001|Reported Event|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
11040783|NCT01256411|BG000|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
11040784|NCT01256411|BG001|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
11040785|NCT01256411|BG002|Baseline|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
11040786|NCT01256411|BG003|Baseline|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
11040787|NCT01256411|BG004|Baseline|Total|Total of all reporting groups
11040788|NCT01256411|FG000|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
11040789|NCT01256411|FG001|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
11040790|NCT01256411|FG002|Participant Flow|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
11040791|NCT01256411|FG003|Participant Flow|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
11040792|NCT01256411|FG004|Participant Flow|LCZ696 Monotherapy|Participants received LCZ696 only.
11040793|NCT01256411|FG005|Participant Flow|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
11040794|NCT01256411|OG000|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
11040795|NCT01256411|OG001|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
11040796|NCT01256411|OG002|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
11040797|NCT01256411|OG003|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
11040798|NCT01256411|OG004|Outcome|LCZ696 100 mg|Participants were down-titrated to 100 mg.
11040799|NCT01256411|OG000|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
11040800|NCT01256411|OG001|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
11040801|NCT01256411|EG000|Reported Event|LCZ696 100 mg|Participants were down-titrated to 100 mg.
11040802|NCT01256411|EG001|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
11040803|NCT01256411|EG002|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
11040804|NCT01256411|EG003|Reported Event|LCZ696 400 mg/Aml|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
11040805|NCT01256411|EG004|Reported Event|LCZ696 400 mg/Aml/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
11040806|NCT01256424|BG000|Baseline|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
11040807|NCT01256424|BG001|Baseline|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
11040808|NCT01256424|BG002|Baseline|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
11040809|NCT01256424|BG003|Baseline|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
11040810|NCT01256424|BG004|Baseline|Total|Total of all reporting groups
11040811|NCT01256424|FG000|Participant Flow|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
11040812|NCT01256424|FG001|Participant Flow|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
11040813|NCT01256424|FG002|Participant Flow|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
11040814|NCT01256424|FG003|Participant Flow|Placebo Ointment Without Illumination|Treatment with a singe dose of 2g placebo ointment, no photoactivation
11040815|NCT01256424|OG000|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
11040816|NCT01256424|OG001|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
11040817|NCT01256424|OG002|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
11040818|NCT01256424|OG003|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
11040819|NCT01256424|OG003|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
11040820|NCT01256424|EG000|Reported Event|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
11040821|NCT01256424|EG001|Reported Event|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
11040822|NCT01256424|EG002|Reported Event|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
11040823|NCT01256424|EG003|Reported Event|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
11040824|NCT01256450|BG000|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11040825|NCT01256450|BG001|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11040826|NCT01256450|BG002|Baseline|Total|Total of all reporting groups
11348922|NCT04134429|OG000|Outcome|Everion®|"The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.~Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data."
11040827|NCT01256450|FG000|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
11040828|NCT01256450|FG001|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11040829|NCT01256450|FG002|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11040830|NCT01256450|OG000|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11040831|NCT01256450|OG001|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
11040832|NCT01256450|EG000|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
11040833|NCT01256450|EG001|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
11040834|NCT01256450|EG002|Reported Event|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
11040835|NCT01256476|BG000|Baseline|Pitavastatin 4 mg Once a Day (QD)|
11226231|NCT02372682|EG001|Reported Event|Control|"Any pediatric patient (0-18 years of age) undergoing evaluation with an abdominal ultrasound as standard of care for evaluation for a diagnosis other than liver disease and in whom the US shows a normal liver, gallbladder, pancreas, spleen, and biliary tree will then be asked to enroll in the research study by undergoing shear wave elastography.~Shear wave sonoelastography: Sonoelastography is to be performed on the liver."
11226232|NCT02372799|BG000|Baseline|Placebo|Dose-matched placebo tablets or capsules, oral administration, once per day.
11226233|NCT02372799|BG001|Baseline|Vilazodone|Vilazodone tablets 15-30 mg. Oral administration, once per day.
11226234|NCT02372799|BG002|Baseline|Fluoxetine|Fluoxetine capsules 20 mg. Oral administration, once per day.
11226235|NCT02372799|BG003|Baseline|Total|Total of all reporting groups
11226236|NCT02372799|FG000|Participant Flow|Placebo|Dose-matched placebo tablets or capsules, oral administration, once per day.
11226237|NCT02372799|FG001|Participant Flow|Vilazodone|Vilazodone tablets 15-30 mg. Oral administration, once per day.
11226238|NCT02372799|FG002|Participant Flow|Fluoxetine|Fluoxetine capsules 20 mg. Oral administration, once per day.
11226239|NCT02372799|OG000|Outcome|Placebo|Dose-matched placebo tablets or capsules, oral administration, once per day.
11226240|NCT02372799|OG001|Outcome|Vilazodone|Vilazodone tablets 15-30 mg. Oral administration, once per day.
11226241|NCT02372799|OG002|Outcome|Fluoxetine|Fluoxetine capsules 20 mg. Oral administration, once per day.
11226242|NCT02372799|EG000|Reported Event|Placebo|Dose-matched placebo tablets or capsules, oral administration, once per day.
11226243|NCT02372799|EG001|Reported Event|Vilazodone|Vilazodone tablets 15-30 mg. Oral administration, once per day.
11226244|NCT02372799|EG002|Reported Event|Fluoxetine|Fluoxetine capsules 20 mg. Oral administration, once per day.
11226245|NCT02373098|BG000|Baseline|FTY720|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od.
11226246|NCT02373098|BG001|Baseline|Healthy Volunteers|The healthy volunteers had only Visit 1 (Day 0) and served as control group for cytokine/chemokine measurements
11226247|NCT02373098|BG002|Baseline|Total|Total of all reporting groups
11348923|NCT04134429|EG000|Reported Event|Everion®|"The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.~Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data."
11226248|NCT02373098|FG000|Participant Flow|FTY720|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od.
11226249|NCT02373098|FG001|Participant Flow|Healthy Volunteers|The healthy volunteers had only Visit 1 (Day 0) and served as control group for cytokine/chemokine measurements
11226250|NCT02373098|OG000|Outcome|Healthy Controls|Healthy volunteers had only Visit 1 (day 0) when serum and whole blood samples were taken.
11226251|NCT02373098|OG001|Outcome|FTY720|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od.
11226252|NCT02373098|OG000|Outcome|Visit 1|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od at visit 1
11226253|NCT02373098|OG001|Outcome|Visit 2|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od at visit 2
11226254|NCT02373098|OG002|Outcome|Visit 3|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od at visit 3
11226255|NCT02373098|OG001|Outcome|Visit 1|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od at visit 1
11226256|NCT02373098|OG002|Outcome|Visit 2|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od at visit 2
11226257|NCT02373098|OG003|Outcome|Visit 3|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od at visit 3
11226258|NCT02373098|EG000|Reported Event|Fingolimod 0.5 mg|Relapsing-remitting multiple sclerosis (RRMS) patients were treated with fingolimod 0.5 mg capsule od.
11226259|NCT02373098|EG001|Reported Event|All Patients|All patients in the trial
11226260|NCT02373124|BG000|Baseline|Open-label|"52 minute infusion of NMDA antagonist~infusion of NMDA antagonist: 52 minute infusion"
11226261|NCT02373124|FG000|Participant Flow|Open-label|"52 minute infusion of NMDA antagonist~infusion of NMDA antagonist: 52 minute infusion"
11226262|NCT02373124|OG000|Outcome|Open-label|"52 minute infusion of NMDA antagonist~infusion of NMDA antagonist: 52 minute infusion"
11226263|NCT02373124|EG000|Reported Event|Open-label|"52 minute infusion of NMDA antagonist~infusion of NMDA antagonist: 52 minute infusion"
11226264|NCT02373137|BG000|Baseline|UT-DSAEK|"Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.~UT-DSAEK~Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam."
11226265|NCT02373137|BG001|Baseline|DMEK|"Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.~DMEK~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.~Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery."
11226266|NCT02373137|BG002|Baseline|Total|Total of all reporting groups
11040836|NCT01256476|BG001|Baseline|Pravastatin 40 mg Once a Day (QD)|
11040837|NCT01256476|BG002|Baseline|Total|Total of all reporting groups
11040838|NCT01256476|FG000|Participant Flow|Pitavastatin 4 mg Once a Day (QD)|
11040839|NCT01256476|FG001|Participant Flow|Pravastatin 40 mg Once a Day (QD)|
11040840|NCT01256476|OG000|Outcome|Pitavastatin 4 mg Once Daily (QD)|
11040841|NCT01256476|OG001|Outcome|Pravastatin 40 mg Once Daily (QD)|
11040842|NCT01256476|EG000|Reported Event|Pitavastatin 4 mg Once a Day (QD)|
11040843|NCT01256476|EG001|Reported Event|Pravastatin 40 mg Once a Day (QD)|
11040844|NCT01256502|BG000|Baseline|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11040845|NCT01256502|FG000|Participant Flow|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11040846|NCT01256502|OG000|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11040847|NCT01256502|OG000|Outcome|Very Difficult to Use|
11040848|NCT01256502|OG001|Outcome|Difficult to Use|
11040849|NCT01256502|OG002|Outcome|Neither Difficult Nor Easy to Use|
11040850|NCT01256502|OG003|Outcome|Easy to Use|
11040851|NCT01256502|OG004|Outcome|Very Easy to Use|
11040852|NCT01256502|EG000|Reported Event|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11040853|NCT01256567|BG000|Baseline|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
11040854|NCT01256567|FG000|Participant Flow|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab (IMC-1121B) administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
11040855|NCT01256567|OG000|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
11040856|NCT01256567|OG000|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel : Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab : Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
11040857|NCT01256567|EG000|Reported Event|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
11040858|NCT01256593|BG000|Baseline|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11040859|NCT01256593|FG000|Participant Flow|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11040860|NCT01256593|OG000|Outcome|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11040861|NCT01256593|EG000|Reported Event|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11040862|NCT01256658|BG000|Baseline|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
11040863|NCT01256658|BG001|Baseline|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
11040864|NCT01256658|BG002|Baseline|Total|Total of all reporting groups
11040865|NCT01256658|FG000|Participant Flow|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
11040866|NCT01256658|FG001|Participant Flow|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
11040867|NCT01256658|OG000|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
11040868|NCT01256658|OG001|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
11040869|NCT01256658|OG001|Outcome|Control|Not applicable to this outcome measure
11040870|NCT01256658|EG000|Reported Event|Intervention - Period 1|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
11040871|NCT01256658|EG001|Reported Event|Control - Period 1|Participants received COA566 treatment for symptomatic malaria episodes only.
11040872|NCT01256658|EG002|Reported Event|Intervention - Period 2 - Follow-up Only|Participants from the intervention group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
11040873|NCT01256658|EG003|Reported Event|Control - Period 2- Follow-up Only|Participants from the control group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
11040874|NCT01256671|BG000|Baseline|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
11040875|NCT01256671|FG000|Participant Flow|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
11040876|NCT01256671|OG000|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
11040877|NCT01256671|EG000|Reported Event|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
11040878|NCT01256684|BG000|Baseline|Placebo|Placebo: Placebo vaginal suppository
11040879|NCT01256684|BG001|Baseline|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
11040880|NCT01256684|BG002|Baseline|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
11040881|NCT01256684|BG003|Baseline|Total|Total of all reporting groups
11040882|NCT01256684|FG000|Participant Flow|Placebo|Placebo: Placebo vaginal suppository
11040883|NCT01256684|FG001|Participant Flow|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
11040884|NCT01256684|FG002|Participant Flow|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
11040885|NCT01256684|OG000|Outcome|Placebo|Placebo: Placebo vaginal suppository
11040886|NCT01256684|OG001|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
11040887|NCT01256684|OG002|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
11040888|NCT01256684|EG000|Reported Event|Placebo|Placebo: Placebo vaginal suppository
11040889|NCT01256684|EG001|Reported Event|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
11040890|NCT01256684|EG002|Reported Event|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
11040891|NCT01256788|BG000|Baseline|Viscosupplementation|"Hyaluronic acid injection~Euflexxa: 4 injections of 2ml of Euflexxa"
11040892|NCT01256788|BG001|Baseline|Saline Injection|Saline: 4 injections of 3 ml of sterile saline
11040893|NCT01256788|BG002|Baseline|No Treatment|No injections given
11040894|NCT01256788|BG003|Baseline|Total|Total of all reporting groups
11040895|NCT01256788|FG000|Participant Flow|Viscosupplementation|"Hyaluronic acid injection~Euflexxa: 4 injections of 2ml of Euflexxa"
11040896|NCT01256788|FG001|Participant Flow|Saline Injection|Saline: 4 injections of 3 ml of sterile saline
11040897|NCT01256788|FG002|Participant Flow|No Treatment|No injection - pain/function questionnaires only through 1 year
11040898|NCT01256788|OG000|Outcome|Viscosupplementation|"Hyaluronic acid injection~Euflexxa: 4 injections of 2ml of Euflexxa"
11040899|NCT01256788|OG001|Outcome|Saline Injection|Saline: 4 injections of 3 ml of sterile saline
11040900|NCT01256788|OG002|Outcome|No Treatment|Patients did not receive neither viscosupplementation nor saline.
11040901|NCT01256788|EG000|Reported Event|Viscosupplementation|"Hyaluronic acid injection~Euflexxa: 4 injections of 2ml of Euflexxa"
11040902|NCT01256788|EG001|Reported Event|Saline Injection|Saline: 4 injections of 3 ml of sterile saline
11040903|NCT01256788|EG002|Reported Event|No Treatment|No injection - pain/function questionnaires only through 1 year
11040904|NCT01256840|BG000|Baseline|Calorie Restricting Group|Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant's self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
11040905|NCT01256840|BG001|Baseline|Normal-eating Controls|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
11040906|NCT01256840|BG002|Baseline|Obese Comparison Group|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
11040907|NCT01256840|BG003|Baseline|Total|Total of all reporting groups
11040908|NCT01256840|FG000|Participant Flow|Calorie Restricting Group|Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant's self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
11040909|NCT01256840|FG001|Participant Flow|Normal-eating Controls|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
11040910|NCT01256840|FG002|Participant Flow|Obese Comparison Group|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
11040911|NCT01256840|OG000|Outcome|Calorie Restricting Group|Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant's self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
11040912|NCT01256840|OG001|Outcome|Normal-eating Controls|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
11040913|NCT01256840|OG002|Outcome|Obese Comparison Group|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
11040914|NCT01256840|EG000|Reported Event|Calorie Restricting Group|Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant's self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
11040915|NCT01256840|EG001|Reported Event|Normal-eating Controls|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
11040916|NCT01256840|EG002|Reported Event|Obese Comparison Group|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
11040917|NCT01256879|BG000|Baseline|Cimetidine|cimetidine 200mg total dose (single dose)
11040918|NCT01256879|FG000|Participant Flow|Cimetidine|cimetidine 200mg total dose (single dose)
11040919|NCT01256879|OG000|Outcome|Experimental: CimTest-A|"cimetidine capsule with hydroxypropyl methylcellulose (HPMC), a type of filler~cimetidine: cimetidine 200mg total dose (single dose)"
11040920|NCT01256879|OG001|Outcome|Experimental: CimTest-B|"cimetidine capsule with magnesium stearate, a type of filler~cimetidine: cimetidine 200mg total dose (single dose)"
11040921|NCT01256879|OG002|Outcome|Active Comparator: Sorbitol-free Cimetidine Solution|"non-commercial cimetidine solution~cimetidine: cimetidine 200mg total dose (single dose)"
11040922|NCT01256879|OG003|Outcome|Experimental: Commercial Cimetidine Solution|"commercial cimetidine solution~cimetidine: cimetidine 200mg total dose (single dose)"
11040923|NCT01256879|EG000|Reported Event|Experimental: CimTest-A|"cimetidine capsule with hydroxypropyl methylcellulose (HPMC), a type of filler~cimetidine: cimetidine 200mg total dose (single dose)"
11040924|NCT01256879|EG001|Reported Event|Experimental: CimTest-B|"cimetidine capsule with magnesium stearate, a type of filler~cimetidine: cimetidine 200mg total dose (single dose)"
11040925|NCT01256879|EG002|Reported Event|Active Comparator: Sorbitol-free Cimetidine Solution|"non-commercial cimetidine solution~cimetidine: cimetidine 200mg total dose (single dose)"
11040926|NCT01256879|EG003|Reported Event|Experimental: Commercial Cimetidine Solution|"commercial cimetidine solution~cimetidine: cimetidine 200mg total dose (single dose)"
11040927|NCT01256918|BG000|Baseline|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
11040928|NCT01256918|FG000|Participant Flow|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
11040929|NCT01256918|OG000|Outcome|Phacodepth|A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .
11040930|NCT01256918|OG000|Outcome|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop during the phacoemulsification procedure.
11040931|NCT01256918|OG000|Outcome|Nuclear Colour|nuclear grading as per LOCS III criteria for cataract shall be done on a decimal scale from 0.1 to 6.9 nuclear colour is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
11040932|NCT01256918|OG001|Outcome|Phacodepth|actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
11040933|NCT01256918|OG000|Outcome|Nuclear Opalescence|nuclear grading as per LOCS III criteria for cataract.nuclear opalescence is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
11040934|NCT01256918|OG001|Outcome|Phacodepth|actual depth of penetration (in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
11040935|NCT01256918|OG000|Outcome|Lens Thickness|lens thickness as measured using an A scan biometer
11040936|NCT01256918|OG001|Outcome|Phacodepth|depth of penetration of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
11040937|NCT01256918|EG000|Reported Event|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
11040938|NCT01256944|BG000|Baseline|Control|The normal women
11040939|NCT01256944|BG001|Baseline|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
11040940|NCT01256944|BG002|Baseline|Total|Total of all reporting groups
11040941|NCT01256944|FG000|Participant Flow|Control|The normal women
11040942|NCT01256944|FG001|Participant Flow|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
11040943|NCT01256944|OG000|Outcome|Control|The normal women
11040944|NCT01256944|OG001|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
11040945|NCT01256944|OG000|Outcome|Obese With PCOS|"BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).~Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
11040946|NCT01256944|OG001|Outcome|Obese With Control|BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
11040947|NCT01256944|OG002|Outcome|Non-obese With PCOS|"BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).~Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
11040948|NCT01256944|OG003|Outcome|Nonb-obese With Control|BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
11040949|NCT01256944|EG000|Reported Event|Control|The normal women
11040950|NCT01256944|EG001|Reported Event|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
11040951|NCT01256983|BG000|Baseline|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
11040952|NCT01256983|BG001|Baseline|No Intervention|10000 Lux after day 63
11040953|NCT01256983|BG002|Baseline|Total|Total of all reporting groups
11040954|NCT01256983|FG000|Participant Flow|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
11040955|NCT01256983|FG001|Participant Flow|No Intervention|10000 Lux after day 63
11040956|NCT01256983|OG000|Outcome|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
11040957|NCT01256983|OG001|Outcome|No Intervention|10000 Lux after day 63
11040958|NCT01256983|EG000|Reported Event|Bright Light Therapy|Bright Light Therapy with 10000 lux beginning at day 21 until day 42
11040959|NCT01256983|EG001|Reported Event|Wait-list Intervention|Wait-list design Intervention. Bright Light Therapy with 10000 lux beginning at day 63 until day 84, when the 9 study weeks were over.
11040960|NCT01257087|BG000|Baseline|Intensive Glycaemic Control|"Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.~Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group."
11040961|NCT01257087|BG001|Baseline|Conservative Glycaemic Control|"Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.~Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group."
11040962|NCT01257087|BG002|Baseline|Total|Total of all reporting groups
11040963|NCT01257087|FG000|Participant Flow|Intensive Glycaemic Control|"Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.~Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group."
11040964|NCT01257087|FG001|Participant Flow|Conservative Glycaemic Control|"Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.~Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group."
11040965|NCT01257087|OG000|Outcome|Intensive Glycaemic Control|"Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.~Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group."
11040966|NCT01257087|OG001|Outcome|Conservative Glycaemic Control|"Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.~Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group."
11040967|NCT01257087|EG000|Reported Event|Intensive Glycaemic Control|"Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.~Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group."
11040968|NCT01257087|EG001|Reported Event|Conservative Glycaemic Control|"Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.~Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group."
11040969|NCT01257204|BG000|Baseline|Dacalatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
11040970|NCT01257204|BG001|Baseline|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
11040971|NCT01257204|BG002|Baseline|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
11040972|NCT01257204|BG003|Baseline|Total|Total of all reporting groups
11040973|NCT01257204|FG000|Participant Flow|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
11040974|NCT01257204|FG001|Participant Flow|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
11040975|NCT01257204|FG002|Participant Flow|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
11040976|NCT01257204|OG000|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
11040977|NCT01257204|OG001|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
11040978|NCT01257204|OG002|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
11040979|NCT01257204|OG000|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
11040980|NCT01257204|OG001|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
11040981|NCT01257204|OG002|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
11040982|NCT01257204|OG000|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 week s.
11040983|NCT01257204|OG001|Outcome|Dacalatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
11040984|NCT01257204|OG002|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα-2a solution for injection 180 mcg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
11040985|NCT01257204|OG000|Outcome|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
11040986|NCT01257204|OG001|Outcome|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks during treatment period and entered into the follow-up period.
11040987|NCT01257204|OG002|Outcome|Placebo: Follow-up|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks during treatment period and entered into the follow-up period.
11040988|NCT01257204|EG000|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
11040989|NCT01257204|EG001|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
11040990|NCT01257204|EG002|Reported Event|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
11040991|NCT01257204|EG003|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
11040992|NCT01257204|EG004|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.
11040993|NCT01257204|EG005|Reported Event|Placebo: Follow-up|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
11040994|NCT01257217|BG000|Baseline|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
11040995|NCT01257217|BG001|Baseline|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
11040996|NCT01257217|BG002|Baseline|Total|Total of all reporting groups
11040997|NCT01257217|FG000|Participant Flow|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
11040998|NCT01257217|FG001|Participant Flow|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
11040999|NCT01257217|OG000|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
11041000|NCT01257217|OG001|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
11041001|NCT01257217|OG000|Outcome|ReSTOR +3/Without|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
11041002|NCT01257217|OG001|Outcome|ReSTOR +3/With|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
11041003|NCT01257217|OG002|Outcome|Acri.LISA/Without|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
11041004|NCT01257217|OG003|Outcome|Acri.LISA/With|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
11041005|NCT01257217|EG000|Reported Event|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
11041006|NCT01257217|EG001|Reported Event|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL
11041007|NCT01257230|BG000|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041008|NCT01257230|BG001|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041009|NCT01257230|BG002|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041010|NCT01257230|BG003|Baseline|Total|Total of all reporting groups
11041011|NCT01257230|FG000|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041012|NCT01257230|FG001|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041013|NCT01257230|FG002|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler.
11041014|NCT01257230|OG000|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041015|NCT01257230|OG001|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041016|NCT01257230|OG002|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041017|NCT01257230|OG001|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks delivered by the Respimat Inhaler
11041018|NCT01257230|EG000|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041019|NCT01257230|EG001|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041020|NCT01257230|EG002|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
11041021|NCT01257347|BG000|Baseline|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
11067084|NCT01395277|BG001|Baseline|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.~During the first visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
11226267|NCT02373137|FG000|Participant Flow|UT-DSAEK|"Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.~UT-DSAEK~Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam."
11226268|NCT02373137|FG001|Participant Flow|DMEK|"Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.~DMEK~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.~Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery."
11226269|NCT02373137|OG000|Outcome|UT-DSAEK|"Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.~UT-DSAEK~Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam."
11226270|NCT02373137|OG001|Outcome|DMEK|"Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.~DMEK~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.~Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery."
11226271|NCT02373137|OG000|Outcome|DSAEK|"Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.~DSAEK~Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam."
11226272|NCT02373137|EG000|Reported Event|UT-DSAEK|"Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.~UT-DSAEK~Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam."
11226273|NCT02373137|EG001|Reported Event|DMEK|"Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.~DMEK~Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.~Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.~Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.~Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.~Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery."
11226274|NCT02373202|BG000|Baseline|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
11067085|NCT01395277|BG002|Baseline|Total|Total of all reporting groups
11226275|NCT02373202|BG001|Baseline|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
11226276|NCT02373202|BG002|Baseline|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
11226277|NCT02373202|BG003|Baseline|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
11226278|NCT02373202|BG004|Baseline|Total|Total of all reporting groups
11226279|NCT02373202|FG000|Participant Flow|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, subcutaneous (SC) injection, q2w along with non-MTX DMARDs for up to 52 weeks.
11041022|NCT01257347|BG001|Baseline|Electronically-measuring Adherence|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
11041023|NCT01257347|BG002|Baseline|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
11041024|NCT01257347|BG003|Baseline|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
11041025|NCT01257347|BG004|Baseline|Total|Total of all reporting groups
11041026|NCT01257347|FG000|Participant Flow|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.35 patients belonged to providers in the control group.
11041027|NCT01257347|FG001|Participant Flow|Electronically-Measuring Adherence Intervention: Physicians|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.
11041028|NCT01257347|FG002|Participant Flow|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
11041029|NCT01257347|FG003|Participant Flow|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
11041030|NCT01257347|OG000|Outcome|Usual Care Control Group|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
11041031|NCT01257347|OG001|Outcome|Electronically-measuring Adherence|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
11041032|NCT01257347|OG000|Outcome|Usual Care Control Group, Adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. Clinicians will be expected to manage hypertension according to usual care.
11226280|NCT02373202|FG001|Participant Flow|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
11041033|NCT01257347|OG001|Outcome|Electronically-measuring Adherence Group, Adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
11041034|NCT01257347|OG000|Outcome|Usual Care Control Group, Non-adherent Only|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
11226281|NCT02373202|FG002|Participant Flow|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
11226282|NCT02373202|FG003|Participant Flow|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
11226283|NCT02373202|OG000|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
11226284|NCT02373202|OG001|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
11226285|NCT02373202|OG002|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
11041035|NCT01257347|OG001|Outcome|Electronically-measuring Adherence Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
11041036|NCT01257347|OG000|Outcome|Usual Care Control Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. Clinicians will be expected to manage hypertension according to usual care.
11041037|NCT01257347|EG000|Reported Event|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care. 35 patients belonged to providers in the control group.
11041038|NCT01257347|EG001|Reported Event|Electronically-Measuring Adherence Intervention: Physicians|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.
11041039|NCT01257347|EG002|Reported Event|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
11041040|NCT01257347|EG003|Reported Event|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
11041041|NCT01257425|BG000|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
11041042|NCT01257425|BG001|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
11041043|NCT01257425|BG002|Baseline|Total|Total of all reporting groups
11041044|NCT01257425|FG000|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
11226286|NCT02373202|OG003|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
11041045|NCT01257425|FG001|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
11041046|NCT01257425|OG000|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
11041047|NCT01257425|OG001|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
11041048|NCT01257425|EG000|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
11041049|NCT01257425|EG001|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
11041050|NCT01257438|BG000|Baseline|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
11041051|NCT01257438|BG001|Baseline|PTA Only|PTA only: Treatment of in-stent restenosis
11041052|NCT01257438|BG002|Baseline|Total|Total of all reporting groups
11041053|NCT01257438|FG000|Participant Flow|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
11041054|NCT01257438|FG001|Participant Flow|PTA Only|PTA only: Treatment of in-stent restenosis
11041055|NCT01257438|OG000|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
11041056|NCT01257438|OG001|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
11041057|NCT01257438|EG000|Reported Event|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
11041058|NCT01257438|EG001|Reported Event|PTA Only|PTA only: Treatment of in-stent restenosis
11041059|NCT01257503|BG000|Baseline|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
11041060|NCT01257503|BG001|Baseline|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
11041061|NCT01257503|BG002|Baseline|Total|Total of all reporting groups
11226287|NCT02373202|EG000|Reported Event|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
11226288|NCT02373202|EG001|Reported Event|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
11226289|NCT02373202|EG002|Reported Event|Sarilumab 150 mg q2w Monotherapy|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
11041062|NCT01257503|FG000|Participant Flow|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
11041063|NCT01257503|FG001|Participant Flow|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
11041064|NCT01257503|OG000|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
11041065|NCT01257503|OG001|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
11041066|NCT01257503|EG000|Reported Event|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
11041067|NCT01257503|EG001|Reported Event|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
11041068|NCT01257542|BG000|Baseline|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
11041069|NCT01257542|BG001|Baseline|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
11041070|NCT01257542|BG002|Baseline|Total|Total of all reporting groups
11041071|NCT01257542|FG000|Participant Flow|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
11041072|NCT01257542|FG001|Participant Flow|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
11041073|NCT01257542|OG000|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
11041074|NCT01257542|OG001|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
11041075|NCT01257542|EG000|Reported Event|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
11041076|NCT01257542|EG001|Reported Event|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
11041077|NCT01257581|BG000|Baseline|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
11041078|NCT01257581|BG001|Baseline|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
11041079|NCT01257581|BG002|Baseline|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
11041080|NCT01257581|BG003|Baseline|Total|Total of all reporting groups
11041081|NCT01257581|FG000|Participant Flow|Creatine 30gm|"Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Creatine is a nutritional supplement and is not approved by the U.S. Food and Drug Administration (FDA) for treating ALS.~creatine: creatine monohydrate powder"
11041082|NCT01257581|FG001|Participant Flow|Tamoxifen 40mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.~tamoxifen: Tamoxifen citrate capsules"
11041083|NCT01257581|FG002|Participant Flow|Tamoxifen 80mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.~tamoxifen: Tamoxifen citrate capsules"
11041084|NCT01257581|OG000|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
11041085|NCT01257581|OG001|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
11041086|NCT01257581|OG002|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
11041087|NCT01257581|EG000|Reported Event|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
11041088|NCT01257581|EG001|Reported Event|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
11041089|NCT01257581|EG002|Reported Event|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
11041090|NCT01257698|BG000|Baseline|Dorzolamide-timolol Topical Drops|Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
11041091|NCT01257698|BG001|Baseline|Standard of Care|Standard post-operative drops
11041092|NCT01257698|BG002|Baseline|Total|Total of all reporting groups
11041093|NCT01257698|FG000|Participant Flow|Dorzolamide-timolol Topical Drops|Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
11041094|NCT01257698|FG001|Participant Flow|Standard of Care|Standard post-operative drops
11041095|NCT01257698|OG000|Outcome|Dorzolamide-timolol Topical Drops|Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
11041096|NCT01257698|OG001|Outcome|Standard of Care|
11041097|NCT01257698|EG000|Reported Event|Dorzolamide-timolol Topical Drops|Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
11041098|NCT01257698|EG001|Reported Event|Standard of Care|Standard post-operative drops
11041099|NCT01257737|BG000|Baseline|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041100|NCT01257737|BG001|Baseline|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041101|NCT01257737|BG002|Baseline|Total|Total of all reporting groups
11041102|NCT01257737|FG000|Participant Flow|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041103|NCT01257737|FG001|Participant Flow|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041104|NCT01257737|OG000|Outcome|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041105|NCT01257737|OG001|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041106|NCT01257737|OG000|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041107|NCT01257737|EG000|Reported Event|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041108|NCT01257737|EG001|Reported Event|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
11041109|NCT01257750|BG000|Baseline|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
11041110|NCT01257750|FG000|Participant Flow|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
11041111|NCT01257750|OG000|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
11041112|NCT01257750|OG000|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Pazopanib (5mg/ml): Topical pazopanib, 4 times per day for 3 weeks"
11041113|NCT01257750|EG000|Reported Event|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
11041114|NCT01257802|BG000|Baseline|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
11041115|NCT01257802|BG001|Baseline|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses~Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
11041116|NCT01257802|BG002|Baseline|Total|Total of all reporting groups
11041117|NCT01257802|FG000|Participant Flow|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
11041118|NCT01257802|FG001|Participant Flow|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses~Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
11041119|NCT01257802|OG000|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
11041120|NCT01257802|OG001|Outcome|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses~Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
11041121|NCT01257802|OG001|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
11041122|NCT01257802|EG000|Reported Event|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
11041123|NCT01257802|EG001|Reported Event|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses~Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
11041124|NCT01257880|BG000|Baseline|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
11041125|NCT01257880|BG001|Baseline|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
11041126|NCT01257880|BG002|Baseline|Total|Total of all reporting groups
11041127|NCT01257880|FG000|Participant Flow|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
11041128|NCT01257880|FG001|Participant Flow|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
11041129|NCT01257880|OG000|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
11041130|NCT01257880|OG001|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
11226290|NCT02373202|EG003|Reported Event|Sarilumab 200 mg q2w Monotherapy|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
11041131|NCT01257880|EG000|Reported Event|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
11041132|NCT01257880|EG001|Reported Event|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
11041133|NCT01258049|BG000|Baseline|ArTiMist|"Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h.~Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable."
11041134|NCT01258049|BG001|Baseline|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable
11041135|NCT01258049|BG002|Baseline|Total|Total of all reporting groups
11041136|NCT01258049|FG000|Participant Flow|ArTiMist|Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h. Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable.
11041137|NCT01258049|FG001|Participant Flow|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable.
11041138|NCT01258049|OG000|Outcome|ArTiMist|
11041139|NCT01258049|OG001|Outcome|Quinine|
11041140|NCT01258049|EG000|Reported Event|ArTiMist|
11041141|NCT01258049|EG001|Reported Event|Quinine|
11041142|NCT01258075|BG000|Baseline|Welchol 3.75 g (High-dose)|Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
11041143|NCT01258075|BG001|Baseline|Welchol 0.625 g (Low-dose)|Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
11041144|NCT01258075|BG002|Baseline|Total|Total of all reporting groups
11041145|NCT01258075|FG000|Participant Flow|Welchol 3.75 g (High-dose)|Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
11041146|NCT01258075|FG001|Participant Flow|Welchol 0.625 g (Low-dose)|Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
11041147|NCT01258075|OG000|Outcome|Welchol 3.75 g (High-dose)|Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
11041148|NCT01258075|OG001|Outcome|Welchol 0.625 g (Low-dose)|Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
11041149|NCT01258075|EG000|Reported Event|Welchol 3.75 g (High-dose)|Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
11041150|NCT01258075|EG001|Reported Event|Welchol 0.625 g (Low-dose)|Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
11226291|NCT02373371|BG000|Baseline|Daylight|"Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline~Metvix®~Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug"
11041151|NCT01258101|BG000|Baseline|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
11041152|NCT01258101|BG001|Baseline|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
11041153|NCT01258101|BG002|Baseline|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
11041154|NCT01258101|BG003|Baseline|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
11041155|NCT01258101|BG004|Baseline|Total|Total of all reporting groups
11041156|NCT01258101|FG000|Participant Flow|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
11041157|NCT01258101|FG001|Participant Flow|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
11041158|NCT01258101|FG002|Participant Flow|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
11041159|NCT01258101|FG003|Participant Flow|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
11041160|NCT01258101|OG000|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
11041161|NCT01258101|OG001|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
11041162|NCT01258101|OG002|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
11041163|NCT01258101|OG003|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
11041164|NCT01258101|EG000|Reported Event|Ribavirin 800 mg/24W|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
11041165|NCT01258101|EG001|Reported Event|Ribavirin 400 mg/24W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
11041166|NCT01258101|EG002|Reported Event|Ribavirin 800 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
11041167|NCT01258101|EG003|Reported Event|Ribavirin 400 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
11041168|NCT01258153|BG000|Baseline|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
11041169|NCT01258153|BG001|Baseline|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
11041170|NCT01258153|BG002|Baseline|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
11041171|NCT01258153|BG003|Baseline|Total|Total of all reporting groups
11041172|NCT01258153|FG000|Participant Flow|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
11041173|NCT01258153|FG001|Participant Flow|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
11041174|NCT01258153|FG002|Participant Flow|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
11041175|NCT01258153|OG000|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
11041176|NCT01258153|OG001|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
11041177|NCT01258153|OG002|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
11041178|NCT01258153|OG000|Outcome|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
11041179|NCT01258153|OG001|Outcome|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
11041180|NCT01258153|EG000|Reported Event|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
11041181|NCT01258153|EG001|Reported Event|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
11041182|NCT01258153|EG002|Reported Event|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
11041183|NCT01258348|BG000|Baseline|All Participants|LY573636 dose was to target a specific maximum concentration (Cmax) as a 2-hour infusion on Days 4 and 25 or Day 4 of a 6-week cycle. Sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks.
11041184|NCT01258348|FG000|Participant Flow|LY 340 μg/mL + Sunitinib 50 mg|LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
11041185|NCT01258348|FG001|Participant Flow|LY 300 μg/mL + Sunitinib 50/37.5 mg|LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
11041186|NCT01258348|FG002|Participant Flow|LY 320 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041187|NCT01258348|FG003|Participant Flow|LY 340 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041188|NCT01258348|FG004|Participant Flow|LY 360 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041189|NCT01258348|OG000|Outcome|LY 340 μg/mL + Sunitinib 50 mg|LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
11041190|NCT01258348|OG001|Outcome|LY 300 μg/mL + Sunitinib 50/37.5 mg|LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
11041191|NCT01258348|OG002|Outcome|LY 320 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041192|NCT01258348|OG003|Outcome|LY 340 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041193|NCT01258348|OG004|Outcome|LY 360 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041194|NCT01258348|OG000|Outcome|LY573636|LY573636 dose was to target a specific maximum concentration (Cmax) as a 2-hour infusion on Days 4 and 25 or Day 4 of a 6-week cycle. Sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks.
11041195|NCT01258348|OG000|Outcome|Sunitinib|LY573636 dose was to target a specific maximum concentration (Cmax) as a 2-hour infusion on Days 4 and 25 or Day 4 of a 6-week cycle. Sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks.
11041196|NCT01258348|EG000|Reported Event|LY 340 μg/mL + Sunitinib 50 mg|LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
11041197|NCT01258348|EG001|Reported Event|LY 300 μg/mL + Sunitinib 50/37.5 mg|LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
11041198|NCT01258348|EG002|Reported Event|LY 320 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041199|NCT01258348|EG003|Reported Event|LY 340 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041200|NCT01258348|EG004|Reported Event|LY 360 μg/mL + Sunitinib 37.5 mg|LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
11041201|NCT01258374|BG000|Baseline|Single Arm With Dual Therapy|"Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD~Raltegravir: Raltegravir, 400 mg bid~Darunavir: Darunavir, 800 mg QD + ritonavir 100 mg QD"
11041202|NCT01258374|FG000|Participant Flow|Single Arm With Dual Therapy|"Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD~Raltegravir: Raltegravir, 400 mg bid~Darunavir: Darunavir, 800 mg QD + ritonavir 100 mg QD"
11041203|NCT01258374|OG000|Outcome|Single Arm With Dual Therapy|"Fifteen patients were screened and enrolled, and all of them completed the study procedures. The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily.~Inclusion criteria were HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. All doses of RAL were administered in the morning and evening, orally with food (light meal). Patients were admitted to the hospital in the morning on day 15 and stayed for 12 hours after the last administration of RAL. The morning dose of RAL and DRV/ RTV was administered in the clinic with a light breakfast (200 mL of whole milk and a ham and cheese sandwich), and blood samples were drawn immediately before breakfast and 0.5 1, 2, 3, 4, 6, 8, 12, and 24 hours afterward"
11041204|NCT01258374|OG000|Outcome|Single Arm With Dual Therapy|"Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD~Raltegravir: Raltegravir, 400 mg bid~Darunavir: Darunavir, 800 mg QD + ritonavir 100 mg QD"
11041205|NCT01258374|EG000|Reported Event|Single Arm With Dual Therapy|"Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD~Raltegravir: Raltegravir, 400 mg bid~Darunavir: Darunavir, 800 mg QD + ritonavir 100 mg QD"
11041206|NCT01258387|BG000|Baseline|Placebo|Patients in each of 7 cohorts randomized to Placebo
11041207|NCT01258387|BG001|Baseline|GGF2 First Dose|First dosing: patients in cohort randomized to GGF2
11041208|NCT01258387|BG002|Baseline|GGF2 Second Escalated Dose|Second dosing: patients in cohort randomized to GGF2
11041209|NCT01258387|BG003|Baseline|GGF2 Third Escalated Dose|Third dosing: patients in cohort randomized to GGF2
11041210|NCT01258387|BG004|Baseline|GGF2 Fourth Escalated Dose|Fourth dosing: patients in cohort randomized to GGF2
11041211|NCT01258387|BG005|Baseline|GGF2 Fifth Escalated Dose|Fifth dosing: patients in cohort randomized to GGF2
11041212|NCT01258387|BG006|Baseline|GGF2 Sixth Escalated Dose|Sixth dosing: patients in cohort randomized to GGF2.
11041213|NCT01258387|BG007|Baseline|GGF2 Seventh Escalataed Dose|Seventh dosing: patients in cohort randomized to GGF2
11041214|NCT01258387|BG008|Baseline|Total|Total of all reporting groups
11348924|NCT04130425|BG000|Baseline|Healthy Individuals|"Subject will be measured for forearm rotation while wearing the custom orthoses Hely & Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis.~Hely & Weber MTC Fracture Brace: Prefabricated muenster orthosis~Thermoplastic orthosis: Muenster orthosis fabricated out of thermoplastics and secured with Velcro~Delta cast orthosis: Muenster orthosis fabricated out of Delta Cast and secured with Velcro"
11041215|NCT01258387|FG000|Participant Flow|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
11041216|NCT01258387|FG001|Participant Flow|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
11041217|NCT01258387|FG002|Participant Flow|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
11041218|NCT01258387|FG003|Participant Flow|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
11041219|NCT01258387|FG004|Participant Flow|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
11041220|NCT01258387|FG005|Participant Flow|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed .
11041221|NCT01258387|FG006|Participant Flow|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
11041222|NCT01258387|OG000|Outcome|Placebo|
11041223|NCT01258387|OG001|Outcome|GGF2 First Dose|
11041224|NCT01258387|OG002|Outcome|GGF2 Second Escalated Dose|
11041225|NCT01258387|OG003|Outcome|GGF2 Third Escalated Dose|
11041226|NCT01258387|OG004|Outcome|GGF2 Fourth Escalated Dose|
11041227|NCT01258387|OG005|Outcome|GGF2 Fifth Escalated Dose|
11041228|NCT01258387|OG006|Outcome|GGF2 Sixth Escalated Dose|
11041229|NCT01258387|OG007|Outcome|GGF2 Seventh Escalataed Dose|
11041230|NCT01258387|EG000|Reported Event|Placebo|
11041231|NCT01258387|EG001|Reported Event|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
11041232|NCT01258387|EG002|Reported Event|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
11041233|NCT01258387|EG003|Reported Event|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
11041234|NCT01258387|EG004|Reported Event|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
11041235|NCT01258387|EG005|Reported Event|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
11041236|NCT01258387|EG006|Reported Event|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed .
11041237|NCT01258387|EG007|Reported Event|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
11041238|NCT01258504|BG000|Baseline|Bosentan|bosentan 125 mg p.o. day 1 single dose bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
11041239|NCT01258504|FG000|Participant Flow|Bosentan|bosentan 125 mg p.o. single dose day 1 bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
11041240|NCT01258504|OG000|Outcome|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
11041241|NCT01258504|OG001|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
11041242|NCT01258504|OG002|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
11041243|NCT01258504|OG000|Outcome|Bosentan After First Dose|bosentan125 mg p.o. day 1 single dose
11041244|NCT01258504|EG000|Reported Event|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
11041245|NCT01258504|EG001|Reported Event|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
11041246|NCT01258504|EG002|Reported Event|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
11041247|NCT01258582|BG000|Baseline|Fingerstick|Fingerstick rapid HIV testing
11041248|NCT01258582|BG001|Baseline|Oral Fluid|Oral fluid rapid HIV testing
11041249|NCT01258582|BG002|Baseline|Total|Total of all reporting groups
11041250|NCT01258582|FG000|Participant Flow|Fingerstick|Fingerstick rapid HIV testing
11041251|NCT01258582|FG001|Participant Flow|Oral Fluid|Oral fluid rapid HIV testing
11041252|NCT01258582|OG000|Outcome|Fingerstick HIV Testing|whole-blood fingerstick rapid HIV testing
11041253|NCT01258582|OG001|Outcome|Oral HIV Testing|oral fluid rapid HIV testing
11041254|NCT01258582|EG000|Reported Event|Fingerstick|Fingerstick rapid HIV testing
11041255|NCT01258582|EG001|Reported Event|Oral Fluid|Oral fluid rapid HIV testing
11041256|NCT01258595|BG000|Baseline|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
11041257|NCT01258595|BG001|Baseline|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
11041258|NCT01258595|BG002|Baseline|Total|Total of all reporting groups
11041259|NCT01258595|FG000|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
11041260|NCT01258595|FG001|Participant Flow|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
11041261|NCT01258595|OG000|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
11041262|NCT01258595|OG001|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
11041263|NCT01258595|EG000|Reported Event|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
11041264|NCT01258595|EG001|Reported Event|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
11041265|NCT01258608|BG000|Baseline|Sorafenib+Placebo|Participants received sorafenib 400 milligrams (mg) orally twice daily continuously in each 21-day cycle. Placebo was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity
11041266|NCT01258608|BG001|Baseline|Sorafenib+Mapatumumab 30 mg/kg|Participants received sorafenib 400 mg orally twice daily continuously in each 21-day cycle. Mapatumumab 30 milligrams per kilogram (mg/kg) was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity
11041267|NCT01258608|BG002|Baseline|Total|Total of all reporting groups
11041268|NCT01258608|FG000|Participant Flow|Sorafenib+Placebo|Participants received sorafenib 400 milligrams (mg) orally twice daily continuously in each 21-day cycle. Placebo was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity
11041269|NCT01258608|FG001|Participant Flow|Sorafenib+Mapatumumab 30 mg/kg|Participants received sorafenib 400 mg orally twice daily continuously in each 21-day cycle. Mapatumumab 30 milligrams per kilogram (mg/kg) was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity.
11041270|NCT01258608|OG000|Outcome|Sorafenib+Placebo|Participants received sorafenib 400 milligrams (mg) orally twice daily continuously in each 21-day cycle. Placebo was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity
11041271|NCT01258608|OG001|Outcome|Sorafenib+Mapatumumab 30 mg/kg|Participants received sorafenib 400 mg orally twice daily continuously in each 21-day cycle. Mapatumumab 30 milligrams per kilogram (mg/kg) was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity
11041272|NCT01258608|OG000|Outcome|Sorafenib+Mapatumumab 30 mg/kg|Participants received sorafenib 400 mg orally twice daily continuously in each 21-day cycle. Mapatumumab 30 milligrams per kilogram (mg/kg) was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity
11041273|NCT01258608|EG000|Reported Event|Sorafenib+Placebo|Participants received sorafenib 400 milligrams (mg) orally twice daily continuously in each 21-day cycle. Placebo was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity.
11041274|NCT01258608|EG001|Reported Event|Sorafenib+Mapatumumab 30 mg/kg|Participants received sorafenib 400 mg orally twice daily continuously in each 21-day cycle. Mapatumumab 30 milligrams per kilogram (mg/kg) was administered via the intravenous route on Day 1 of each 21-day cycle. The treatments were administered until radiologic disease progression or unacceptable toxicity.
11041275|NCT01258660|BG000|Baseline|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11226292|NCT02373371|BG001|Baseline|Conventional Treatment|"Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline~Metvix®~Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug"
11041276|NCT01258660|BG001|Baseline|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11041277|NCT01258660|BG002|Baseline|Total|Total of all reporting groups
11041278|NCT01258660|FG000|Participant Flow|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11041279|NCT01258660|FG001|Participant Flow|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11226293|NCT02373371|BG002|Baseline|Total|Total of all reporting groups
11226294|NCT02373371|FG000|Participant Flow|Daylight|"Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline~Metvix®~Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug"
11226295|NCT02373371|FG001|Participant Flow|Conventional Treatment|"Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline~Metvix®~Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug"
10848928|NCT00292591|EG001|Reported Event|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11041280|NCT01258660|OG000|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11041281|NCT01258660|OG001|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11041282|NCT01258660|OG000|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11041283|NCT01258660|EG000|Reported Event|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11041284|NCT01258660|EG001|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
11041285|NCT01258738|BG000|Baseline|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
11041286|NCT01258738|BG001|Baseline|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
11041287|NCT01258738|BG002|Baseline|Total|Total of all reporting groups
11041288|NCT01258738|FG000|Participant Flow|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
11041289|NCT01258738|FG001|Participant Flow|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
11041290|NCT01258738|OG000|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
11041291|NCT01258738|OG001|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
11041292|NCT01258738|EG000|Reported Event|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
11041293|NCT01258738|EG001|Reported Event|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
11041294|NCT01258790|BG000|Baseline|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
11041295|NCT01258790|BG001|Baseline|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
11041296|NCT01258790|BG002|Baseline|Total|Total of all reporting groups
11041297|NCT01258790|FG000|Participant Flow|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
11041298|NCT01258790|FG001|Participant Flow|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
11041299|NCT01258790|OG000|Outcome|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
11041300|NCT01258790|OG001|Outcome|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
11041301|NCT01258790|EG000|Reported Event|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
11041302|NCT01258790|EG001|Reported Event|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
11041303|NCT01258855|BG000|Baseline|Combination Arm (Ziv-Afilbercept+HD IL2)|Each course consisted of 2 cycles of HD IL2 at 600,000 IU/kg IV every 8 hours for up to 14 doses (1st cycle), followed by a period of 1 week rest and readmission for HD IL2 (2nd cycle). Ziv-aflibercept was given concurrently at 3 mg/kg IV every 2 weeks, starting 2 weeks prior to IL2 in course 1. In the absence of disease progression, maintenance ziv-aflibercept was given at 4 mg/kg every 2 weeks after completion of IL2
11041304|NCT01258855|BG001|Baseline|Mono-therapy Arm (HD IL2 Alone)|Patients received HD IL2 for a maximum of 3 courses (6 cycles)
11041305|NCT01258855|BG002|Baseline|Total|Total of all reporting groups
11041306|NCT01258855|FG000|Participant Flow|Combination Arm (Ziv-Afilbercept+HD IL2)|Each course consisted of 2 cycles of HD IL2 at 600,000 IU/kg IV every 8 hours for up to 14 doses (1st cycle), followed by a period of 1 week rest and readmission for HD IL2 (2nd cycle). Ziv-aflibercept was given concurrently at 3 mg/kg IV every 2 weeks, starting 2 weeks prior to IL2 in course 1. In the absence of disease progression, maintenance ziv-aflibercept was given at 4 mg/kg every 2 weeks after completion of IL2
11041307|NCT01258855|FG001|Participant Flow|Mono-therapy Arm (HD IL2 Alone)|Patients received HD IL2 for a maximum of 3 courses (6 cycles)
11041308|NCT01258855|OG000|Outcome|Combination Arm (Ziv-Afilbercept+HD IL2)|Each course consisted of 2 cycles of HD IL2 at 600,000 IU/kg IV every 8 hours for up to 14 doses (1st cycle), followed by a period of 1 week rest and readmission for HD IL2 (2nd cycle). Ziv-aflibercept was given concurrently at 3 mg/kg IV every 2 weeks, starting 2 weeks prior to IL2 in course 1. In the absence of disease progression, maintenance ziv-aflibercept was given at 4 mg/kg every 2 weeks after completion of IL2
11041309|NCT01258855|OG001|Outcome|Mono-therapy Arm (HD IL2 Alone)|Patients received HD IL2 for a maximum of 3 courses (6 cycles)
11041310|NCT01258855|EG000|Reported Event|Combination Arm (Ziv-Afilbercept+HD IL2)|Each course consisted of 2 cycles of HD IL2 at 600,000 IU/kg IV every 8 hours for up to 14 doses (1st cycle), followed by a period of 1 week rest and readmission for HD IL2 (2nd cycle). Ziv-aflibercept was given concurrently at 3 mg/kg IV every 2 weeks, starting 2 weeks prior to IL2 in course 1. In the absence of disease progression, maintenance ziv-aflibercept was given at 4 mg/kg every 2 weeks after completion of IL2
11041311|NCT01258855|EG001|Reported Event|Mono-therapy Arm (HD IL2 Alone)|Patients received HD IL2 for a maximum of 3 courses (6 cycles)
11041312|NCT01258985|BG000|Baseline|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
11041313|NCT01258985|BG001|Baseline|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
11041314|NCT01258985|BG002|Baseline|Total|Total of all reporting groups
11041315|NCT01258985|FG000|Participant Flow|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
11041316|NCT01258985|FG001|Participant Flow|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
11041317|NCT01258985|OG000|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
11041318|NCT01258985|OG001|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
10848929|NCT00292591|EG002|Reported Event|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
11041319|NCT01258985|EG000|Reported Event|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
11041320|NCT01258985|EG001|Reported Event|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
11041321|NCT01258998|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
11041322|NCT01258998|FG000|Participant Flow|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
11041323|NCT01258998|OG000|Outcome|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
11041324|NCT01258998|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
11041325|NCT01259011|BG000|Baseline|Control|As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
11041326|NCT01259011|BG001|Baseline|SPIRIT Intervention|the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
11041327|NCT01259011|BG002|Baseline|Total|Total of all reporting groups
11041328|NCT01259011|FG000|Participant Flow|Control|As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
11041329|NCT01259011|FG001|Participant Flow|SPIRIT Intervention|the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
11041330|NCT01259011|OG000|Outcome|Control|As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
11041331|NCT01259011|OG001|Outcome|SPIRIT Intervention|the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
11041332|NCT01259011|OG000|Outcome|Control|Written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. A social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
11041333|NCT01259011|OG001|Outcome|SPIRIT Intervention|"The SPIRIT intervention is a two-session, 1½ hour-long, structured intervention that is composed of six steps (assessing representations, identifying and exploring gaps and concerns, creating conditions for conceptual change, introducing replacement information, summarizing, and setting goals and planning), presented to both patient and surrogate by a trained nurse interventionist in a face-to-face interview format based on the representational approach.~the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers"
11041334|NCT01259011|EG000|Reported Event|Control|As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
11041335|NCT01259011|EG001|Reported Event|SPIRIT Intervention|the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
11041336|NCT01259063|BG000|Baseline|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response. Patients demonstrating a CR (by cystoscopy and cytology) or a Partial Response at their Cycle 12 cystoscopy will be observed with serial cystoscopies every 3 months.
11041337|NCT01259063|FG000|Participant Flow|Everolimus and Intravesical Gemcitabine|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response.
11041338|NCT01259063|OG000|Outcome|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
11041339|NCT01259063|EG000|Reported Event|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
11041340|NCT01259089|BG000|Baseline|Arm I|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041341|NCT01259089|FG000|Participant Flow|Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041342|NCT01259089|FG001|Participant Flow|Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041343|NCT01259089|FG002|Participant Flow|Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041344|NCT01259089|FG003|Participant Flow|Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041345|NCT01259089|FG004|Participant Flow|Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041346|NCT01259089|FG005|Participant Flow|Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041347|NCT01259089|OG000|Outcome|Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041348|NCT01259089|OG001|Outcome|Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041349|NCT01259089|OG002|Outcome|Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041350|NCT01259089|OG003|Outcome|Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041351|NCT01259089|OG004|Outcome|Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11226296|NCT02373371|OG000|Outcome|Daylight|"Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline~Metvix®~Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug"
11041352|NCT01259089|OG000|Outcome|Arm I|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041353|NCT01259089|EG000|Reported Event|Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041354|NCT01259089|EG001|Reported Event|Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041355|NCT01259089|EG002|Reported Event|Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041356|NCT01259089|EG003|Reported Event|Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041357|NCT01259089|EG004|Reported Event|Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041358|NCT01259089|EG005|Reported Event|Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib|"Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally~Hsp90 inhibitor AUY922: Given IV~laboratory biomarker analysis: Correlative studies~needle biopsy: Undergo image-guided needle biopsy (correlative studies)~mutation analysis: Correlative studies~pharmacological study: Correlative studies"
11041359|NCT01259102|BG000|Baseline|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
11041360|NCT01259102|BG001|Baseline|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
11041361|NCT01259102|BG002|Baseline|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
11041362|NCT01259102|BG003|Baseline|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
11041363|NCT01259102|BG004|Baseline|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
11226297|NCT02373371|OG001|Outcome|Conventional Treatment|"Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline~Metvix®~Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug"
11041364|NCT01259102|BG005|Baseline|Total|Total of all reporting groups
11041365|NCT01259102|FG000|Participant Flow|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
11226298|NCT02373371|EG000|Reported Event|Daylight|"Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline~Metvix®~Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug"
11226299|NCT02373371|EG001|Reported Event|Conventional Treatment|"Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline~Metvix®~Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug"
11041366|NCT01259102|FG001|Participant Flow|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
11041367|NCT01259102|FG002|Participant Flow|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
11041368|NCT01259102|FG003|Participant Flow|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
11041369|NCT01259102|FG004|Participant Flow|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
11041370|NCT01259102|OG000|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
11041371|NCT01259102|OG001|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
11041372|NCT01259102|OG002|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
11041373|NCT01259102|OG003|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
11041374|NCT01259102|OG004|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
11041375|NCT01259102|EG000|Reported Event|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
11041376|NCT01259102|EG001|Reported Event|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
11041377|NCT01259102|EG002|Reported Event|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
11041378|NCT01259102|EG003|Reported Event|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
11041379|NCT01259102|EG004|Reported Event|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
11041380|NCT01259115|BG000|Baseline|Overall Study|Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 1; Washout Period for 4 to 18 days; Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 2.
11041381|NCT01259115|FG000|Participant Flow|Sequence A: BTDS 10 With Ketoconazole (Test) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily (Test) first;~Washout Period of 4 to 18 days;~Period 2: BTDS 10 with ketoconazole placebo tablets twice daily."
11041382|NCT01259115|FG001|Participant Flow|Sequence B: BTDS 10 With Placebo (Reference) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo tablets twice daily (Reference) first~Washout Period of 4 to 18 days;~Period 2: BTDS 10 with ketoconazole 200 mg tablets twice daily."
11041383|NCT01259115|OG000|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
11041384|NCT01259115|OG001|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
11041385|NCT01259115|OG000|Outcome|All Subjects|Subjects who received BTDS with Ketoconazole treatment
11041386|NCT01259115|OG000|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
11041387|NCT01259115|OG001|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
11041388|NCT01259115|OG000|Outcome|BTDS 10 With Ketoconazole|Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily.
11041389|NCT01259115|OG001|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo oral tablets twice daily.
11041390|NCT01259115|EG000|Reported Event|BTDS With Ketoconazole|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole 200 mg oral tablets twice daily.
11041391|NCT01259115|EG001|Reported Event|BTDS With Placebo|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole placebo oral tablets twice daily.
11041392|NCT01259128|BG000|Baseline|SER120 500 ng|All participants received 500 ng once daily
11041393|NCT01259128|BG001|Baseline|SER120 750 ng|All participants received 750 ng once daily
11041394|NCT01259128|BG002|Baseline|Total|Total of all reporting groups
11041395|NCT01259128|FG000|Participant Flow|SER120 500 ng|All participants received 500 ng once daily
11041396|NCT01259128|FG001|Participant Flow|SER120 750 ng|All participants received 750 ng once daily
11041397|NCT01259128|OG000|Outcome|SER120 500 ng|All participants received 500 ng once daily
11041398|NCT01259128|OG001|Outcome|SER120 750 ng|All participants received 750 ng once daily
11041399|NCT01259128|EG000|Reported Event|SER120 500 ng|All participants received 500 ng once daily
11041400|NCT01259128|EG001|Reported Event|SER120 750 ng|All participants received 750 ng once daily
11041401|NCT01259245|BG000|Baseline|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
11041402|NCT01259245|BG001|Baseline|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
11041403|NCT01259245|BG002|Baseline|Total|Total of all reporting groups
11041404|NCT01259245|FG000|Participant Flow|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
11041405|NCT01259245|FG001|Participant Flow|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
11041406|NCT01259245|OG000|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
11041407|NCT01259245|OG001|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
11041408|NCT01259245|OG000|Outcome|Pulmonary Rehabilitation Program|
11041409|NCT01259245|OG001|Outcome|PRP+Tai Chi|
11041410|NCT01259245|EG000|Reported Event|PRP + Tai Chi|Tai Chi elements added to PRP program
11041411|NCT01259245|EG001|Reported Event|Pulmonary Rehabilitation Program PRP|Subjects who received formal pulmonary rehabilitation program
11041412|NCT01259297|BG000|Baseline|Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
11041413|NCT01259297|BG001|Baseline|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
11041414|NCT01259297|BG002|Baseline|Aliskiren + Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
11041415|NCT01259297|BG003|Baseline|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
11041416|NCT01259297|BG004|Baseline|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
11041417|NCT01259297|BG005|Baseline|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
11041418|NCT01259297|BG006|Baseline|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were run-in stratum randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
11041419|NCT01259297|BG007|Baseline|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
11041420|NCT01259297|BG008|Baseline|Total|Total of all reporting groups
11041421|NCT01259297|FG000|Participant Flow|Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
11041422|NCT01259297|FG001|Participant Flow|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
11041423|NCT01259297|FG002|Participant Flow|Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
10848930|NCT00292942|BG000|Baseline|Placebo|"Mannitol (200 mg/vial) diluted in phosphate buffer and delivered in an equivalent volume by subject's weight as artesunate.~Placebo: Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight."
11041424|NCT01259297|FG003|Participant Flow|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
11041425|NCT01259297|FG004|Participant Flow|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
11041426|NCT01259297|FG005|Participant Flow|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
11041427|NCT01259297|FG006|Participant Flow|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
11041428|NCT01259297|FG007|Participant Flow|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
11041429|NCT01259297|OG000|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
11041430|NCT01259297|OG001|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
11041431|NCT01259297|OG000|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
11041432|NCT01259297|OG000|Outcome|Aliskiren+Amlodipine/HCTZ Group|This reporting group includes all the patients who has received Aliskiren plus an additional BP lowering drug (Amlodipine or Hydrochlorothiazide). This reporting group includes patients from arms such as Aliskiren + Hydrochlorothiazide (HCTZ) and Aliskiren + Amlodipine.
11041433|NCT01259297|OG001|Outcome|Placebo|This reporting group includes all the patients who has received placebo of aliskiren plus placebo of an additional BP lowering drug (amlodipine or hydrochlorothiazide). This reporting group includes patients from arms such as Placebo for Aliskiren + Placebo for HCTZ and Placebo for aliskiren + Placebo for Amlodipine .
11041434|NCT01259297|EG000|Reported Event|Run-in Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received Hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
11041435|NCT01259297|EG001|Reported Event|Run-in Period: Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
11041436|NCT01259297|EG002|Reported Event|Double Blind Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
11041437|NCT01259297|EG003|Reported Event|Double Blind Period: Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
11041438|NCT01259297|EG004|Reported Event|Double Blind Period: Aliskiren + Amlodipine|"In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
11041439|NCT01259297|EG005|Reported Event|Double Blind Period: Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
11041440|NCT01259297|EG006|Reported Event|Double Blind Period: HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
11041441|NCT01259297|EG007|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
11041442|NCT01259297|EG008|Reported Event|Double Blind Period: Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
11041443|NCT01259297|EG009|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for Amlod|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
11041444|NCT01259375|BG000|Baseline|All Groups|All patients that received treatment.
11041445|NCT01259375|FG000|Participant Flow|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
11041446|NCT01259375|OG000|Outcome|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
11041447|NCT01259375|OG000|Outcome|All Patients|"All participants who received Amrubicin.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
11041448|NCT01259375|OG000|Outcome|All Groups|All patients who had a partial or greater response
11041449|NCT01259375|EG000|Reported Event|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
11041450|NCT01259388|BG000|Baseline|Lithium Then Observation|"Lithium carbonate was dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.~During observation subjects continued on their standard of care disease modifying agent (or no agent at all if judged not appropriate by the treating physician)."
11041451|NCT01259388|BG001|Baseline|Observation Then Lithium|"During observation subjects continued on their standard of care disease modifying agent (or no agent at all if judged not appropriate by the treating physician).~Lithium carbonate was dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time."
11041452|NCT01259388|BG002|Baseline|Total|Total of all reporting groups
11041453|NCT01259388|FG000|Participant Flow|Lithium First (One Year), Then Observation (One Year)|Subjects randomized to this group took lithium carbonate dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time, followed by a year of observation (standard care). No washout period occurred between the treatment periods.
11041454|NCT01259388|FG001|Participant Flow|Observation First (One Year), Then Lithium (One Year)|Subjects randomized to this group were observed for a year of observation (standard care), followed by a year of lithium carbonate dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time. No washout period occurred between the treatment periods.
11041455|NCT01259388|OG000|Outcome|Lithium|"Lithium-treatment phase~Lithium Carbonate: Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time."
11041456|NCT01259388|OG001|Outcome|Observation|During observation subjects continued on their standard of care disease modifying agent (or no agent at all if judged not appropriate by the treating physician).
11041457|NCT01259388|EG000|Reported Event|Lithium|"Lithium-treatment phase~Lithium Carbonate: Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time."
11041458|NCT01259388|EG001|Reported Event|Observation|During observation subjects continued on their standard of care disease modifying agent (or no agent at all if judged not appropriate by the treating physician).
11041459|NCT01259401|BG000|Baseline|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
11041460|NCT01259401|BG001|Baseline|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
11041461|NCT01259401|BG002|Baseline|Total|Total of all reporting groups
11041462|NCT01259401|FG000|Participant Flow|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
11041463|NCT01259401|FG001|Participant Flow|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
11041464|NCT01259401|OG000|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
11041465|NCT01259401|OG001|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
11041466|NCT01259401|EG000|Reported Event|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
11041467|NCT01259401|EG001|Reported Event|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
11041468|NCT01259427|BG000|Baseline|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
11041469|NCT01259427|BG001|Baseline|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
11041470|NCT01259427|BG002|Baseline|Total|Total of all reporting groups
10848931|NCT00292942|BG001|Baseline|2 mg/kg Intravenous Artesunate|"2 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041471|NCT01259427|FG000|Participant Flow|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
11041472|NCT01259427|FG001|Participant Flow|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
11041473|NCT01259427|OG000|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
11041474|NCT01259427|OG001|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
11041475|NCT01259427|OG001|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
11348925|NCT04130425|FG000|Participant Flow|Hely & Weber MTC Fracture Brace, Thermoplastic Orthosis and Delta-Cast Orthosis|Each participant received a sequence of three different orthotic interventions and served as his/her own match control to assess forearm range of motion.
11348926|NCT04130425|OG000|Outcome|Thermoplastic Results|The 30 healthy participants trialing the thermoplastic orthosis. Total arc of motion reported.
11041476|NCT01259427|EG000|Reported Event|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
11041477|NCT01259427|EG001|Reported Event|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
11041478|NCT01259440|BG000|Baseline|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
11041479|NCT01259440|BG001|Baseline|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
11041480|NCT01259440|BG002|Baseline|Total|Total of all reporting groups
11041481|NCT01259440|FG000|Participant Flow|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
11041482|NCT01259440|FG001|Participant Flow|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
11041483|NCT01259440|OG000|Outcome|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
11041484|NCT01259440|OG001|Outcome|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
11041485|NCT01259440|EG000|Reported Event|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
11041486|NCT01259440|EG001|Reported Event|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
11041487|NCT01259466|BG000|Baseline|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
11041488|NCT01259466|BG001|Baseline|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
11041489|NCT01259466|BG002|Baseline|Total|Total of all reporting groups
11041490|NCT01259466|FG000|Participant Flow|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
11041491|NCT01259466|FG001|Participant Flow|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
11041492|NCT01259466|OG000|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
11041493|NCT01259466|OG001|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
11041494|NCT01259466|EG000|Reported Event|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
11041495|NCT01259466|EG001|Reported Event|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
11041496|NCT01259492|BG000|Baseline|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041497|NCT01259492|BG001|Baseline|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041498|NCT01259492|BG002|Baseline|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041499|NCT01259492|BG003|Baseline|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041500|NCT01259492|BG004|Baseline|Total|Total of all reporting groups
11041501|NCT01259492|FG000|Participant Flow|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041502|NCT01259492|FG001|Participant Flow|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041503|NCT01259492|FG002|Participant Flow|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041504|NCT01259492|FG003|Participant Flow|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
10848932|NCT00292942|BG002|Baseline|4 mg/kg Intravenous Artesunate|"4 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041505|NCT01259492|OG000|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041506|NCT01259492|OG001|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11226300|NCT02373813|BG000|Baseline|Double-Blind Treatment: Methotrexate Monotherapy|"Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg)."
11226301|NCT02373813|BG001|Baseline|Double-Blind Treatment: Etanercept Monotherapy|"Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg)."
11226302|NCT02373813|BG002|Baseline|Double-Blind Treatment: Etanercept Plus Methotrexate|"Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment)."
11226303|NCT02373813|BG003|Baseline|Total|Total of all reporting groups
11226304|NCT02373813|FG000|Participant Flow|Open Label Run-In: Etanercept Plus Methotrexate|Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care.
11226305|NCT02373813|FG001|Participant Flow|Double-Blind Treatment: Methotrexate Monotherapy|"Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg)."
11226306|NCT02373813|FG002|Participant Flow|Double-Blind Treatment: Etanercept Monotherapy|"Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg)."
11226307|NCT02373813|FG003|Participant Flow|Double-Blind Treatment: Etanercept Plus Methotrexate|"Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment)."
11041507|NCT01259492|OG002|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041508|NCT01259492|OG003|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041509|NCT01259492|OG000|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
11041510|NCT01259492|EG000|Reported Event|All Ritalin LA|"All Ritalin LA:~In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients continued on their optimal dose."
11041511|NCT01259492|EG001|Reported Event|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
11041512|NCT01259596|BG000|Baseline|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
10848933|NCT00292942|BG003|Baseline|8 mg/kg Intravenous Artesunate|"8 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041513|NCT01259596|BG001|Baseline|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041514|NCT01259596|BG002|Baseline|Total|Total of all reporting groups
11041515|NCT01259596|FG000|Participant Flow|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041516|NCT01259596|FG001|Participant Flow|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041517|NCT01259596|OG000|Outcome|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041518|NCT01259596|OG001|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041519|NCT01259596|OG000|Outcome|Cognitive Behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~cognitive behavioral therapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041520|NCT01259596|OG001|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~nondirective supportive therapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041521|NCT01259596|EG000|Reported Event|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041522|NCT01259596|EG001|Reported Event|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
11041523|NCT01259713|BG000|Baseline|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
11041524|NCT01259713|BG001|Baseline|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
11041525|NCT01259713|BG002|Baseline|Total|Total of all reporting groups
11348927|NCT04130425|OG001|Outcome|Delta-Cast Results|The 30 healthy participants trialing the Delta-Cast orthosis. Results are total arc of motion.
10848934|NCT00292942|BG004|Baseline|Total|Total of all reporting groups
11041526|NCT01259713|FG000|Participant Flow|Liposomal Amphotericin B|Liposomal amphotericin B (AmBisome®) 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
11041527|NCT01259713|FG001|Participant Flow|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
11041528|NCT01259713|OG000|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
11041529|NCT01259713|OG001|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
11041530|NCT01259713|EG000|Reported Event|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
10848935|NCT00292942|FG000|Participant Flow|Placebo|"Mannitol (200 mg/vial) diluted in phosphate buffer and delivered in an equivalent volume by subject's weight as artesunate.~Placebo: Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight."
11041531|NCT01259713|EG001|Reported Event|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
11041532|NCT01259726|BG000|Baseline|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
11041533|NCT01259726|BG001|Baseline|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
11041534|NCT01259726|BG002|Baseline|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
11041535|NCT01259726|BG003|Baseline|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
11041536|NCT01259726|BG004|Baseline|Total|Total of all reporting groups
11041537|NCT01259726|FG000|Participant Flow|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
11041538|NCT01259726|FG001|Participant Flow|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
11041539|NCT01259726|FG002|Participant Flow|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
11041540|NCT01259726|FG003|Participant Flow|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
11041541|NCT01259726|OG000|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
11041542|NCT01259726|OG001|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
11041543|NCT01259726|OG002|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
11041544|NCT01259726|OG003|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
11041545|NCT01259726|EG000|Reported Event|Placebo|Placebo: 10 mL placebo once daily for 14 days
11041546|NCT01259726|EG001|Reported Event|VP20621 Low Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
11041547|NCT01259726|EG002|Reported Event|VP20621 High Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
11041548|NCT01259726|EG003|Reported Event|VP20621 High Dose|VP20621: VP20621 as oral liquid once daily for 14 days
11041549|NCT01259856|BG000|Baseline|PEGASYS|"The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment."
11041550|NCT01259856|BG001|Baseline|Hydroxyurea|"Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment."
11041551|NCT01259856|BG002|Baseline|Total|Total of all reporting groups
11041552|NCT01259856|FG000|Participant Flow|PEGASYS|"The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment."
11041553|NCT01259856|FG001|Participant Flow|Hydroxyurea|"Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment."
11041554|NCT01259856|OG000|Outcome|PEGASYS|"The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment."
11041555|NCT01259856|OG001|Outcome|Hydroxyurea|"Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment."
11041556|NCT01259856|EG000|Reported Event|PEGASYS|"The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment."
11041557|NCT01259856|EG001|Reported Event|Hydroxyurea|"Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment."
11041558|NCT01259869|BG000|Baseline|PX-866|PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
11041559|NCT01259869|FG000|Participant Flow|PX-866|PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
11041560|NCT01259869|OG000|Outcome|PX-866|PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
11041561|NCT01259869|EG000|Reported Event|PX-866|PX-866: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
11041562|NCT01260142|BG000|Baseline|Cohort 1 (Sequence A)|Participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
11041563|NCT01260142|BG001|Baseline|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
11041564|NCT01260142|BG002|Baseline|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
11041565|NCT01260142|BG003|Baseline|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
11041566|NCT01260142|BG004|Baseline|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
11041567|NCT01260142|BG005|Baseline|Cohort 3 ( Sequence F)|Participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
11041568|NCT01260142|BG006|Baseline|Total|Total of all reporting groups
11041569|NCT01260142|FG000|Participant Flow|Cohort 1 (Sequence A)|Participants were administered intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
11041570|NCT01260142|FG001|Participant Flow|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
11041571|NCT01260142|FG002|Participant Flow|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
11041572|NCT01260142|FG003|Participant Flow|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
11041573|NCT01260142|FG004|Participant Flow|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
11041574|NCT01260142|FG005|Participant Flow|Cohort 3 (Sequence F)|Participants were administered an intravenous IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
11041575|NCT01260142|OG000|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
11041576|NCT01260142|OG001|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
11041577|NCT01260142|OG002|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
11041578|NCT01260142|OG000|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
11041579|NCT01260142|OG001|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
11041580|NCT01260142|OG002|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
11041581|NCT01260142|OG003|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
11041582|NCT01260142|OG004|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
11041583|NCT01260142|OG005|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
11226308|NCT02373813|OG000|Outcome|Double-Blind Treatment: Methotrexate Monotherapy|"Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg)."
11041584|NCT01260142|OG000|Outcome|Cohort 1 (Fospropofol 6.5 : Propofol 0.65)|"Cohort 1 (Sequence A): participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.~Cohort 1: Sequence B: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium."
11041585|NCT01260142|OG001|Outcome|Cohort 2 (Fospropofol 10.0 : Propofol 1.0)|"Cohort 2 (Sequence C): Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.~Cohort 2 (Sequence D): Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium."
11041586|NCT01260142|OG002|Outcome|Cohort 3 (Fospropofol 15.0 : Propofol 1.5)|"Cohort 3 (Sequence E): participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.~Cohort (Sequence F): participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium."
11041587|NCT01260142|EG000|Reported Event|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
11041588|NCT01260142|EG001|Reported Event|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
11041589|NCT01260142|EG002|Reported Event|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
11041590|NCT01260142|EG003|Reported Event|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
11041591|NCT01260142|EG004|Reported Event|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
11041592|NCT01260142|EG005|Reported Event|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
11041593|NCT01260181|BG000|Baseline|Erlotinib|Participants received erlotinib 150 millgrams (mg) orally daily until disease progression.
11041594|NCT01260181|FG000|Participant Flow|Erlotinib|Participants received erlotinib 150 millgrams (mg) orally daily until disease progression.
11041595|NCT01260181|OG000|Outcome|Erlotinib|Participants received erlotinib 150 millgrams (mg) orally daily until disease progression.
11041596|NCT01260181|EG000|Reported Event|Erlotinib|Participants received erlotinib 150 millgrams (mg) orally daily until disease progression.
11041597|NCT01260194|BG000|Baseline|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator's discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
11041598|NCT01260194|FG000|Participant Flow|Trastuzumab|Trastuzumab was administered at a loading dose of 8 milligram per kilogram (mg/kg) body weight on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator's discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
11041599|NCT01260194|OG000|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator's discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
11041600|NCT01260194|EG000|Reported Event|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator's discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
11041601|NCT01260272|BG000|Baseline|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
11041602|NCT01260272|BG001|Baseline|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
11041603|NCT01260272|BG002|Baseline|Total|Total of all reporting groups
11226309|NCT02373813|OG001|Outcome|Double-Blind Treatment: Etanercept Monotherapy|"Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg)."
10848936|NCT00292942|FG001|Participant Flow|2 mg/kg Intravenous Artesunate|"2 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041604|NCT01260272|FG000|Participant Flow|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
11041605|NCT01260272|FG001|Participant Flow|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
11041606|NCT01260272|OG000|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
11041607|NCT01260272|OG001|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
11041608|NCT01260272|OG000|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
11041609|NCT01260272|OG001|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
11041610|NCT01260272|EG000|Reported Event|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
11041611|NCT01260272|EG001|Reported Event|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
11041612|NCT01260311|BG000|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
11041613|NCT01260311|FG000|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 milligram (mg) or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
11041614|NCT01260311|OG000|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
11041615|NCT01260311|EG000|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
11041616|NCT01260324|BG000|Baseline|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
11041617|NCT01260324|BG001|Baseline|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
11041618|NCT01260324|BG002|Baseline|Total|Total of all reporting groups
11348928|NCT04130425|OG002|Outcome|Hely and Weber Fracture Brace MTC|The 30 healthy participants trialing the Hely and Weber Fracture Brace MTC. Results reported in total arc of motion.
11041619|NCT01260324|FG000|Participant Flow|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
11041620|NCT01260324|FG001|Participant Flow|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
11041621|NCT01260324|OG000|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
11041622|NCT01260324|OG000|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
11041623|NCT01260324|EG000|Reported Event|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
11041624|NCT01260324|EG001|Reported Event|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
11041625|NCT01260350|BG000|Baseline|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
11041626|NCT01260350|BG001|Baseline|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041627|NCT01260350|BG002|Baseline|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041628|NCT01260350|BG003|Baseline|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041629|NCT01260350|BG004|Baseline|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041630|NCT01260350|BG005|Baseline|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041631|NCT01260350|BG006|Baseline|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
11041632|NCT01260350|BG007|Baseline|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041633|NCT01260350|BG008|Baseline|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
11041634|NCT01260350|BG009|Baseline|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041635|NCT01260350|BG010|Baseline|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041636|NCT01260350|BG011|Baseline|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041637|NCT01260350|BG012|Baseline|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041638|NCT01260350|BG013|Baseline|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041639|NCT01260350|BG014|Baseline|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041640|NCT01260350|BG015|Baseline|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041641|NCT01260350|BG016|Baseline|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041642|NCT01260350|BG017|Baseline|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041643|NCT01260350|BG018|Baseline|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
11041644|NCT01260350|BG019|Baseline|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
11041645|NCT01260350|BG020|Baseline|Total|Total of all reporting groups
11041646|NCT01260350|FG000|Participant Flow|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
11041647|NCT01260350|FG001|Participant Flow|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
10848937|NCT00292942|FG002|Participant Flow|4 mg/kg Intravenous Artesunate|"4 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
10848938|NCT00292942|FG003|Participant Flow|8 mg/kg Intravenous Artesunate|"8 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041648|NCT01260350|FG002|Participant Flow|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041649|NCT01260350|FG003|Participant Flow|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041650|NCT01260350|FG004|Participant Flow|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041651|NCT01260350|FG005|Participant Flow|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041652|NCT01260350|FG006|Participant Flow|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
11041653|NCT01260350|FG007|Participant Flow|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041654|NCT01260350|FG008|Participant Flow|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
11041655|NCT01260350|FG009|Participant Flow|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041656|NCT01260350|FG010|Participant Flow|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041657|NCT01260350|FG011|Participant Flow|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041658|NCT01260350|FG012|Participant Flow|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041659|NCT01260350|FG013|Participant Flow|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041660|NCT01260350|FG014|Participant Flow|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041661|NCT01260350|FG015|Participant Flow|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041662|NCT01260350|FG016|Participant Flow|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041663|NCT01260350|FG017|Participant Flow|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041664|NCT01260350|FG018|Participant Flow|Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
11041665|NCT01260350|FG019|Participant Flow|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
11041666|NCT01260350|FG020|Participant Flow|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
11041667|NCT01260350|FG021|Participant Flow|Group 22: LDV/SOF FDC 6 wk: GT 1, TN|Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
11041668|NCT01260350|OG000|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
11041669|NCT01260350|OG001|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041670|NCT01260350|OG002|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041671|NCT01260350|OG003|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041672|NCT01260350|OG004|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041673|NCT01260350|OG005|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041674|NCT01260350|OG006|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
11041675|NCT01260350|OG007|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041676|NCT01260350|OG008|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
11041677|NCT01260350|OG009|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041678|NCT01260350|OG010|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041679|NCT01260350|OG011|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041680|NCT01260350|OG012|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041681|NCT01260350|OG013|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041682|NCT01260350|OG014|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041683|NCT01260350|OG015|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041684|NCT01260350|OG016|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041685|NCT01260350|OG017|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041686|NCT01260350|OG018|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
11041687|NCT01260350|OG019|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
11041688|NCT01260350|OG005|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
11041689|NCT01260350|OG006|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041690|NCT01260350|OG007|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
11041691|NCT01260350|OG008|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041692|NCT01260350|OG009|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041693|NCT01260350|OG010|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041694|NCT01260350|OG011|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041695|NCT01260350|OG012|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041696|NCT01260350|OG013|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041697|NCT01260350|OG014|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041698|NCT01260350|OG015|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041699|NCT01260350|OG016|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
11041700|NCT01260350|EG000|Reported Event|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
11041701|NCT01260350|EG001|Reported Event|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041702|NCT01260350|EG002|Reported Event|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041703|NCT01260350|EG003|Reported Event|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041704|NCT01260350|EG004|Reported Event|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041705|NCT01260350|EG005|Reported Event|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041706|NCT01260350|EG006|Reported Event|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
11041707|NCT01260350|EG007|Reported Event|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041708|NCT01260350|EG008|Reported Event|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
11041709|NCT01260350|EG009|Reported Event|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041710|NCT01260350|EG010|Reported Event|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041711|NCT01260350|EG011|Reported Event|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041712|NCT01260350|EG012|Reported Event|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041713|NCT01260350|EG013|Reported Event|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
11041714|NCT01260350|EG014|Reported Event|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
11041715|NCT01260350|EG015|Reported Event|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041716|NCT01260350|EG016|Reported Event|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
11041717|NCT01260350|EG017|Reported Event|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
11041718|NCT01260350|EG018|Reported Event|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
11041719|NCT01260350|EG019|Reported Event|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
11041720|NCT01260454|BG000|Baseline|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
11041721|NCT01260454|FG000|Participant Flow|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
11348929|NCT04130425|OG000|Outcome|Hely & Weber MTC Fracture Brace|Each participant is their own matched control for the three orthoses. This data describes only the Hely & Weber MTC Fracture Brace.
11348930|NCT04130425|OG001|Outcome|Thermoplastic Orthosis|Each participant is their own matched control for the three orthoses. This data describes only the Thermoplastic Orthosis
11041722|NCT01260454|OG000|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
11041723|NCT01260454|EG000|Reported Event|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
11041724|NCT01260467|BG000|Baseline|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
11041725|NCT01260467|FG000|Participant Flow|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
11041726|NCT01260467|OG000|Outcome|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
11041727|NCT01260467|OG000|Outcome|Memantine Arm|memantine: 10 milligrams orally twice a day
11041728|NCT01260467|OG000|Outcome|Single Arm|No adverse events reported.
11041729|NCT01260467|EG000|Reported Event|Single Agent Memantine Group|NO data to report
11041730|NCT01260493|BG000|Baseline|Conventional Care, Controlgroup|conventional care, control group
11041731|NCT01260493|BG001|Baseline|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
11041732|NCT01260493|BG002|Baseline|Total|Total of all reporting groups
11041733|NCT01260493|FG000|Participant Flow|Conventional Care, Controlgroup|conventional care, control group
11041734|NCT01260493|FG001|Participant Flow|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
11041735|NCT01260493|OG000|Outcome|Conventional Care, Controlgroup|conventional care, control group
11041736|NCT01260493|OG001|Outcome|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
11041737|NCT01260493|EG000|Reported Event|Conventional Care, Controlgroup|conventional care, control group
11041738|NCT01260493|EG001|Reported Event|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
11041739|NCT01260584|BG000|Baseline|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
11041740|NCT01260584|BG001|Baseline|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
11041741|NCT01260584|BG002|Baseline|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
11041742|NCT01260584|BG003|Baseline|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
11041743|NCT01260584|BG004|Baseline|Total|Total of all reporting groups
11041744|NCT01260584|FG000|Participant Flow|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
11041745|NCT01260584|FG001|Participant Flow|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
11041746|NCT01260584|FG002|Participant Flow|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
10848939|NCT00292942|OG000|Outcome|Placebo|"Mannitol (200 mg/vial) diluted in phosphate buffer and delivered in an equivalent volume by subject's weight as artesunate.~Placebo: Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight."
11041747|NCT01260584|FG003|Participant Flow|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
11041748|NCT01260584|OG000|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
11041749|NCT01260584|OG001|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
11041750|NCT01260584|OG002|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
11041751|NCT01260584|OG003|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
11041752|NCT01260584|EG000|Reported Event|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
11041753|NCT01260584|EG001|Reported Event|Prasugrel Non-Smokers|"participants who do not currently smoke while receiving prasugrel as test medication during study. 1 participant who started the arm was not at risk."
11041754|NCT01260584|EG002|Reported Event|Clopidogrel Smokers|"participants who currently smoke while receiving clopidogrel as test medication during study. 2 participants who started this arm were not At risk."
11041755|NCT01260584|EG003|Reported Event|Clopidogrel Non-Smokers|"participants who do not currently smoke while receiving clopidogrel as test medication during study. 1 participant who started this arm was not at risk."
11041756|NCT01260649|BG000|Baseline|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
11041757|NCT01260649|BG001|Baseline|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
11041758|NCT01260649|BG002|Baseline|Total|Total of all reporting groups
11041759|NCT01260649|FG000|Participant Flow|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
11041760|NCT01260649|FG001|Participant Flow|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
11041761|NCT01260649|OG000|Outcome|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
11041762|NCT01260649|OG001|Outcome|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
11041763|NCT01260649|EG000|Reported Event|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
10848940|NCT00292942|OG001|Outcome|2 mg/kg Intravenous Artesunate|"2 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041764|NCT01260649|EG001|Reported Event|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
11041765|NCT01260662|BG000|Baseline|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041766|NCT01260662|BG001|Baseline|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041767|NCT01260662|BG002|Baseline|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041768|NCT01260662|BG003|Baseline|Total|Total of all reporting groups
11041769|NCT01260662|FG000|Participant Flow|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11348931|NCT04130425|OG002|Outcome|Delta-Cast Orthosis|Each participant is their own matched control for the three orthoses. This data describes only the Delta Cast orthosis
11041770|NCT01260662|FG001|Participant Flow|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041771|NCT01260662|FG002|Participant Flow|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041772|NCT01260662|OG000|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041773|NCT01260662|OG001|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041774|NCT01260662|OG002|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041775|NCT01260662|EG000|Reported Event|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041776|NCT01260662|EG001|Reported Event|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041777|NCT01260662|EG002|Reported Event|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
11041778|NCT01260688|BG000|Baseline|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041779|NCT01260688|BG001|Baseline|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041780|NCT01260688|BG002|Baseline|Total|Total of all reporting groups
10848941|NCT00292942|OG002|Outcome|4 mg/kg Intravenous Artesunate|"4 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041781|NCT01260688|FG000|Participant Flow|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041782|NCT01260688|FG001|Participant Flow|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041783|NCT01260688|OG000|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041784|NCT01260688|OG001|Outcome|Arm II - Cediranib Alone|Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041785|NCT01260688|OG000|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate (20mg) once daily and oral dasatinib (100mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
11041786|NCT01260688|OG001|Outcome|Arm II - Cediranib Alone|Patients receive oral cediranib maleate (20mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
11041787|NCT01260688|OG001|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041788|NCT01260688|EG000|Reported Event|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate (20mg) once daily and oral dasatinib (100mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
11041789|NCT01260688|EG001|Reported Event|Arm II - Cediranib Alone|Patients receive oral cediranib maleate (20mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
11041790|NCT01260701|BG000|Baseline|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041791|NCT01260701|FG000|Participant Flow|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041792|NCT01260701|OG000|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041793|NCT01260701|EG000|Reported Event|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11041794|NCT01260883|BG000|Baseline|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
11041795|NCT01260883|BG001|Baseline|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
11041796|NCT01260883|BG002|Baseline|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
11041797|NCT01260883|BG003|Baseline|Total|Total of all reporting groups
11041798|NCT01260883|FG000|Participant Flow|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
11041799|NCT01260883|FG001|Participant Flow|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
11041800|NCT01260883|FG002|Participant Flow|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
11041801|NCT01260883|OG000|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration, analyzed by NONMEM population pharmacokinetic methodology
11041802|NCT01260883|OG001|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
11041803|NCT01260883|OG002|Outcome|Placebo|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
11041804|NCT01260883|OG000|Outcome|S- Ketorolac Volume Distribution, Central|stereo-specific ketorolac analysis by NONMEM
11041805|NCT01260883|OG001|Outcome|R+ Ketorolac Volume Distribution, Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
11041806|NCT01260883|OG002|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
11041807|NCT01260883|OG000|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
11041808|NCT01260883|OG001|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
11041809|NCT01260883|OG000|Outcome|S- Ketorolac Half-life|stereo-specific ketorolac analysis by NONMEM
11041810|NCT01260883|OG001|Outcome|R+ Ketorolac Half-life|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
11041811|NCT01260883|OG000|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving active drug intravenously after surgery
11041812|NCT01260883|OG001|Outcome|Placebo|infants receiving placebo infusion intravenously after surgery
11041813|NCT01260883|OG000|Outcome|Ketorolac 1 or 0.5 mg/kg|infants given ketorolac intravenously after surgery
11041814|NCT01260883|OG001|Outcome|Placebo|infants given placebo intravenously after surgery
11041815|NCT01260883|OG000|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac analysis by NONMEM
11041816|NCT01260883|OG001|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
11041817|NCT01260883|OG000|Outcome|S- Ketorolac Volume Distribution Central|stereo-specific ketorolac analysis by NONMEM
10848942|NCT00292942|OG003|Outcome|8 mg/kg Intravenous Artesunate|"8 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041818|NCT01260883|OG001|Outcome|R+ Ketorolac Volume Distribution Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
11041819|NCT01260883|OG000|Outcome|S- Ketorolac Half-life|noncompartmental ketorolac analysis
11041820|NCT01260883|OG001|Outcome|R+ Ketorolac Half-life|noncompartmental analysis of stereo-isomers of ketorolac
11041821|NCT01260883|OG002|Outcome|Placebo|noncompartmental analysis of stereo-isomers of ketorolac
11041822|NCT01260883|OG000|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac infusion after surgery
11041823|NCT01260883|OG001|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
11041824|NCT01260883|OG000|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac after surgery
11041825|NCT01260883|EG000|Reported Event|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
11041826|NCT01260883|EG001|Reported Event|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
11041827|NCT01260883|EG002|Reported Event|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
11041828|NCT01260896|BG000|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11041829|NCT01260896|BG001|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11041830|NCT01260896|BG002|Baseline|Total|Total of all reporting groups
11041831|NCT01260896|FG000|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11041832|NCT01260896|FG001|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11041833|NCT01260896|OG000|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
11041834|NCT01260896|OG001|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
11041835|NCT01260896|EG000|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11041836|NCT01260896|EG001|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11041837|NCT01260922|BG000|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
11041838|NCT01260922|BG001|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
11041839|NCT01260922|BG002|Baseline|Total|Total of all reporting groups
11041840|NCT01260922|FG000|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
11041841|NCT01260922|FG001|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
11041842|NCT01260922|OG000|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
11041843|NCT01260922|OG001|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
11041844|NCT01260922|EG000|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
11041845|NCT01260922|EG001|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
11041846|NCT01260948|BG000|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
11041847|NCT01260948|BG001|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
11041848|NCT01260948|BG002|Baseline|Total|Total of all reporting groups
11041849|NCT01260948|FG000|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
11041850|NCT01260948|FG001|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
11041851|NCT01260948|OG000|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
11041852|NCT01260948|OG001|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
11041853|NCT01260948|EG000|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
11041854|NCT01260948|EG001|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
11041855|NCT01261000|BG000|Baseline|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
11041856|NCT01261000|FG000|Participant Flow|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
11041857|NCT01261000|OG000|Outcome|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
11041858|NCT01261000|EG000|Reported Event|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
11066542|NCT01392859|EG001|Reported Event|Initial Treatment: Placebo First, Then Levocetirizine|"Only a small sub-set of the overall study participants were included in this analysis.~Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.~Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.~These participants also went through the laser doppler portion prior to the crossover portion of the study.~Note: Adverse Events (AE) were recorded by arm therefore AE's cannot be provided for each intervention separately. This data is no longer available to retrospectively separate AE's out by intervention."
11066543|NCT01392859|EG002|Reported Event|Laser Doppler Portion Only|Participants who completed Only Laser Doppler portion of the study.
11066544|NCT01392963|BG000|Baseline|Botox, Then Placebo|At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).
11066545|NCT01392963|BG001|Baseline|Placebo, Then Botox|At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).
11066546|NCT01392963|BG002|Baseline|Total|Total of all reporting groups
11066547|NCT01392963|FG000|Participant Flow|Botox, Then Placebo|At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).
11066548|NCT01392963|FG001|Participant Flow|Placebo, Then Botox|At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).
11066549|NCT01392963|OG000|Outcome|Placebo, Then Botox|"At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).~botulinum toxin type A neurotoxin complex: 29-40 U injection~Placebo: 29-40 U 0.9% NaCl injection"
11066550|NCT01392963|OG001|Outcome|Botox, Then Placebo|At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).
11041859|NCT01261052|BG000|Baseline|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
11041860|NCT01261052|FG000|Participant Flow|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
11041861|NCT01261052|OG000|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
11348932|NCT04130425|EG000|Reported Event|Hely & Weber MTC Fracture Brace|Participants served as their own matched controls for each of the three orthoses.
11348933|NCT04130425|EG001|Reported Event|Thermoplastic Orthosis|Participants served as their own matched controls for each of the three orthoses.
11348934|NCT04130425|EG002|Reported Event|Delta-Cast Orthosis|Participants served as their own matched controls for each of the three orthoses.
11041862|NCT01261052|EG000|Reported Event|APD Only Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
10887268|NCT00499603|OG000|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
11066551|NCT01392963|OG000|Outcome|Placebo, Then Botox (Week 6)|Group received placebo injection at week 0 of study followed by a Botox injection at week 12. HDRS-21 scores were done six weeks after each injection (week 6 and week 18).
11066552|NCT01392963|OG001|Outcome|Placebo, Then Botox (Week 18)|Group received placebo injection at week 0 of study followed by a Botox injection at week 12. HDRS-21 scores were done six weeks after each injection (week 6 and week 18).
11348935|NCT04138498|BG000|Baseline|Sequence 1 (ADBC)|"Subjects in sequence ADBC will receive study treatments in the following order: Focalin XR 5 mg capsule, CTx-1301 50 mg tablet, CTx-1301 6.25 mg tablet, Focalin XR 40 mg capsule.~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation"
11348936|NCT04138498|BG001|Baseline|Sequence 2 (BACD)|"Subjects in sequence BACD will receive study treatments in the following order: CTx-1301 6.25 mg tablet, Focalin XR 5 mg capsule, Focalin XR 40 mg capsule, CTx-1301 50 mg tablet.~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation"
11348937|NCT04138498|BG002|Baseline|Sequence 3 (CBDA)|"Subjects in sequence CBDA will receive study treatments in the following order: Focalin XR 40 mg capsule, CTx-1301 6.25 mg tablet, CTx-1301 50 mg tablet, Focalin XR 5 mg capsule.~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation"
11041863|NCT01261052|EG001|Reported Event|FMPD/APD Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
11041864|NCT01261325|BG000|Baseline|Placebo|Matching placebo tablets administered twice daily
11041865|NCT01261325|BG001|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
11041866|NCT01261325|BG002|Baseline|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
11041867|NCT01261325|BG003|Baseline|Total Title|
11041868|NCT01261325|FG000|Participant Flow|Placebo|Matching placebo tablets administered twice daily
11041869|NCT01261325|FG001|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
11041870|NCT01261325|FG002|Participant Flow|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
11041871|NCT01261325|OG000|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
11041872|NCT01261325|OG001|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
11041873|NCT01261325|OG002|Outcome|Placebo|Matching placebo tablets administered twice daily
11041874|NCT01261325|OG000|Outcome|Placebo|Matching placebo tablets administered twice daily
11041875|NCT01261325|OG001|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
11041876|NCT01261325|OG002|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
11041877|NCT01261325|EG000|Reported Event|Placebo|Matching placebo tablets administered twice daily
11041878|NCT01261325|EG001|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
11041879|NCT01261325|EG002|Reported Event|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
11041880|NCT01261338|BG000|Baseline|Olestra|"Non-absorbable fat~olestra : non-absorbable dietary fat"
11041881|NCT01261338|BG001|Baseline|Vegetable Oil|absorbable fat
11041882|NCT01261338|BG002|Baseline|Total|Total of all reporting groups
11041883|NCT01261338|FG000|Participant Flow|Olestra|"Non-absorbable fat~olestra : non-absorbable dietary fat"
11041884|NCT01261338|FG001|Participant Flow|Vegetable Oil|absorbable fat
11041885|NCT01261338|OG000|Outcome|Olestra|"Non-absorbable fat~olestra : non-absorbable dietary fat"
11041886|NCT01261338|OG001|Outcome|Vegetable Oil|absorbable fat
11041887|NCT01261338|EG000|Reported Event|Olestra|"Non-absorbable fat~olestra : non-absorbable dietary fat"
11041888|NCT01261338|EG001|Reported Event|Vegetable Oil|absorbable fat
11041889|NCT01261390|BG000|Baseline|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
11041890|NCT01261390|BG001|Baseline|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
11041891|NCT01261390|BG002|Baseline|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
11041892|NCT01261390|BG003|Baseline|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
11041893|NCT01261390|BG004|Baseline|Total|Total of all reporting groups
11041894|NCT01261390|FG000|Participant Flow|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
11041895|NCT01261390|FG001|Participant Flow|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
11041896|NCT01261390|FG002|Participant Flow|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
11041897|NCT01261390|FG003|Participant Flow|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
11041898|NCT01261390|OG000|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
11041899|NCT01261390|OG001|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
11041900|NCT01261390|OG000|Outcome|Active PAP With RT Support Only|Participants randomly assigned to either the Active PAP with RT Support arm (ActiveBeh).
11041901|NCT01261390|OG001|Outcome|Active PAP With Motivational Enhancement|Participants randomly assigned to Active PAP with Behavioral Modification arm (Active+Beh).
11041902|NCT01261390|OG000|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
11041903|NCT01261390|OG001|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
11041904|NCT01261390|OG002|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
11041905|NCT01261390|OG003|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
11041906|NCT01261390|OG002|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
11041907|NCT01261390|EG000|Reported Event|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
11041908|NCT01261390|EG001|Reported Event|Sham PAP (Sham)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
11041909|NCT01261390|EG002|Reported Event|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
11041910|NCT01261390|EG003|Reported Event|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
11041911|NCT01261507|BG000|Baseline|Radiologists|Board Certified Radiologists working in the Washington, DC, Baltimore region
11041912|NCT01261507|FG000|Participant Flow|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
11041913|NCT01261507|OG000|Outcome|Board Certified Radiologists Working Without Software|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
11041914|NCT01261507|OG001|Outcome|Radiologists Working With Software|Each radiologist serves as own control, working without and with software. This is the arm working with software
11041915|NCT01261507|OG000|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
11041916|NCT01261507|OG001|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
11041917|NCT01261507|EG000|Reported Event|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
11041918|NCT01261559|BG000|Baseline|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
11041919|NCT01261559|BG001|Baseline|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
11041920|NCT01261559|BG002|Baseline|Total|Total of all reporting groups
11041921|NCT01261559|FG000|Participant Flow|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
11041922|NCT01261559|FG001|Participant Flow|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
11041923|NCT01261559|OG000|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
11041924|NCT01261559|OG001|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
11041925|NCT01261559|OG001|Outcome|Chrysalis CT|"Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.~Chrysalis breast displacement device: Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement."
11041926|NCT01261559|EG000|Reported Event|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
11041927|NCT01261559|EG001|Reported Event|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
10848943|NCT00292942|OG000|Outcome|2 mg/kg Intravenous Artesunate|"2 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041928|NCT01261611|BG000|Baseline|Dysport NG|"500U (1mL) administered as intramuscular injection on day 1 of treatment cycle 1 and 2.~250U (0.5mL), 500U (1mL) or 750U (1.5mL) administered as intramuscular injection on day 1 of treatment cycle 3.~250U (0.5mL), 500U (1mL), 750U (1.5mL) or 1000U (2mL) administered as intramuscular injection on day 1 of treatment cycle 4 and 5.~Botulinum type A toxin (Dysport NG): I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles."
11041929|NCT01261611|BG001|Baseline|Dysport|"500U (1mL) injected as intramuscular injection on day 1 of treatment cycle 1.~Botulinum type A toxin (Dysport®): I.M. injection on day 1 of treatment cycle 1."
11041930|NCT01261611|BG002|Baseline|Placebo|"1mL administered as, intramuscular injection on day 1 of treatment cycle 1.~Placebo: I.M. injection on day 1 of treatment cycle 1."
11041931|NCT01261611|BG003|Baseline|Total|Total of all reporting groups
11041932|NCT01261611|FG000|Participant Flow|Dysport NG|Up to 5 treatment cycles of Dysport NG
11041933|NCT01261611|FG001|Participant Flow|Dysport|1 treatment cycle of Dysport
11041934|NCT01261611|FG002|Participant Flow|Placebo|1 treatment cycle of placebo
11041935|NCT01261611|OG000|Outcome|Dysport NG|500U
11041936|NCT01261611|OG001|Outcome|Dysport|500U
11041937|NCT01261611|OG002|Outcome|Placebo|
11041938|NCT01261611|OG000|Outcome|Dysport NG|All doses
11041939|NCT01261611|EG000|Reported Event|Dysport NG, 250U|Subjects in the safety population were analysed as treated.
11041940|NCT01261611|EG001|Reported Event|Dysport NG, 500U|Subjects in the safety population were analysed as treated.
11041941|NCT01261611|EG002|Reported Event|Dysport NG, 750U|Subjects in the safety population were analysed as treated.
11041942|NCT01261611|EG003|Reported Event|Dysport NG, 1000U|Subjects in the safety population were analysed as treated.
11041943|NCT01261611|EG004|Reported Event|Dysport, 500U|The safety population was analysed using subjects as treated. One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population, and the Dysport group for the ITT population.
11041944|NCT01261611|EG005|Reported Event|Placebo|The safety population was analysed using subjects as treated. One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population, and the Dysport group for the ITT population.
11041945|NCT01261624|BG000|Baseline|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg BID|Patient received the dose of 0.50 mg/kg for 12 weeks in fed condition
11041946|NCT01261624|BG001|Baseline|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patient received the dose of 0.75 mg/kg for 12 weeks in fed condition
11041947|NCT01261624|BG002|Baseline|Total|Total of all reporting groups
11041948|NCT01261624|FG000|Participant Flow|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg Twice Daily (BID)|Patients (pts) received the dose of 0.50 mg/kg BID for 12 weeks in fed condition
11041949|NCT01261624|FG001|Participant Flow|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patients received the dose of 0.75 mg/kg BID for 12 weeks in fed conditions
11041950|NCT01261624|OG000|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
11041951|NCT01261624|OG001|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
11041952|NCT01261624|OG002|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator's decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
11041953|NCT01261624|OG003|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
11041954|NCT01261624|OG004|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
11041955|NCT01261624|EG000|Reported Event|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
11041956|NCT01261624|EG001|Reported Event|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
11041957|NCT01261624|EG002|Reported Event|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator's decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort). Safety data selected for high and low dose in this cohort are not available, this kind of analysis has not been performed.
11041958|NCT01261624|EG003|Reported Event|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
11041959|NCT01261624|EG004|Reported Event|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
11041960|NCT01261780|BG000|Baseline|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
11041961|NCT01261780|BG001|Baseline|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
10848944|NCT00292942|OG001|Outcome|4 mg/kg Intravenous Artesunate|"4 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11041962|NCT01261780|BG002|Baseline|Total|Total of all reporting groups
11041963|NCT01261780|FG000|Participant Flow|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
11041964|NCT01261780|FG001|Participant Flow|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
11041965|NCT01261780|OG000|Outcome|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
11041966|NCT01261780|OG001|Outcome|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
11149088|NCT01868542|EG001|Reported Event|Insulin Detemir (2-4-6-8 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :~>10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir."
11149089|NCT01868594|BG000|Baseline|Subetta|"Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus"
11149090|NCT01868594|BG001|Baseline|Placebo|"Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11149091|NCT01868594|BG002|Baseline|Total|Total of all reporting groups
11149092|NCT01868594|FG000|Participant Flow|Subetta|"Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus"
11149093|NCT01868594|FG001|Participant Flow|Placebo|"Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11149094|NCT01868594|OG000|Outcome|Subetta|"Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus"
11149095|NCT01868594|OG001|Outcome|Placebo|"Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11149096|NCT01868594|OG000|Outcome|Subetta|"Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day).~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus"
11149097|NCT01868594|OG001|Outcome|Placebo|"Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day).~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11149098|NCT01868594|EG000|Reported Event|Subetta|"Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day).~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus"
11149099|NCT01868594|EG001|Reported Event|Placebo|"Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day).~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11149100|NCT01868633|BG000|Baseline|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
11149101|NCT01868633|BG001|Baseline|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
11149102|NCT01868633|BG002|Baseline|Total|Total of all reporting groups
11149103|NCT01868633|FG000|Participant Flow|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
11149104|NCT01868633|FG001|Participant Flow|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
11149105|NCT01868633|OG000|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
11149106|NCT01868633|OG001|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
11149107|NCT01868633|EG000|Reported Event|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
11149108|NCT01868633|EG001|Reported Event|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
11149109|NCT01868646|BG000|Baseline|Subetta|"Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus"
11149110|NCT01868646|BG001|Baseline|Placebo|"Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11149111|NCT01868646|BG002|Baseline|Total|Total of all reporting groups
11226310|NCT02373813|OG001|Outcome|Double-Blind Treatment: Etanercept Plus Methotrexate|"Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment)."
11041967|NCT01261780|EG000|Reported Event|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
11041968|NCT01261780|EG001|Reported Event|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
11041969|NCT01261793|BG000|Baseline|Placebo Weekly (SS)|Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
11041970|NCT01261793|BG001|Baseline|Epratuzumab 1200 mg Every Other Week (SS)|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
11041971|NCT01261793|BG002|Baseline|Epratuzumab 600 mg Weekly (SS)|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
11041972|NCT01261793|BG003|Baseline|Total Title|
11041973|NCT01261793|FG000|Participant Flow|Placebo Weekly (RS)|Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
11041974|NCT01261793|FG001|Participant Flow|Epratuzumab 1200 mg Every Other Week (RS)|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
11041975|NCT01261793|FG002|Participant Flow|Epratuzumab 600 mg Weekly (RS)|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
11041976|NCT01261793|OG000|Outcome|Placebo Weekly (FAS)|Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
11041977|NCT01261793|OG001|Outcome|Epratuzumab 1200 mg Every Other Week (FAS)|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
11041978|NCT01261793|OG002|Outcome|Epratuzumab 600 mg Weekly (FAS)|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
11041979|NCT01261793|EG000|Reported Event|Placebo Weekly (SS)|Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
11041980|NCT01261793|EG001|Reported Event|Epratuzumab 1200 mg Every Other Week (SS)|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
11041981|NCT01261793|EG002|Reported Event|Epratuzumab 600 mg Weekly (SS)|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
11041982|NCT01261819|BG000|Baseline|Transurethral Laparoscope|"These patients had cystoscopy performed with the transurethral laparoscope.~cystoscopy"
11041983|NCT01261819|BG001|Baseline|Traditional Cystoscopy|"These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the gold standard.~cystoscopy"
11041984|NCT01261819|BG002|Baseline|Total|Total of all reporting groups
11041985|NCT01261819|FG000|Participant Flow|Transurethral Laparoscope|These patients had cystoscopy performed with the transurethral laparoscope.
11041986|NCT01261819|FG001|Participant Flow|Traditional Cystoscopy|"These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the gold standard."
11041987|NCT01261819|OG000|Outcome|Transurethral Laparoscope|These patients had cystoscopy performed with the transurethral laparoscope.
11041988|NCT01261819|OG001|Outcome|Traditional Cystoscopy|"These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the gold standard."
11041989|NCT01261819|EG000|Reported Event|Transurethral Laparoscope|These patients had cystoscopy performed with the transurethral laparoscope.
11041990|NCT01261819|EG001|Reported Event|Traditional Cystoscopy|"These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the gold standard."
11041991|NCT01261975|BG000|Baseline|Cataract Surgery|Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System
11041992|NCT01261975|FG000|Participant Flow|Cataract Surgery|Cataract surgery with phacoemulsification. Eligible patients were randomized to undergo cataract surgery using the 1.8 mm coaxial micro incision technique in either the right eye or the left eye. The fellow eye was assigned to undergo cataract surgery using the 2.75 mm standard incision. The Stellaris Vision Enhancement System was used for the surgery.
11041993|NCT01261975|OG000|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
11041994|NCT01261975|OG001|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
11041995|NCT01261975|EG000|Reported Event|Co-Axial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System.
11041996|NCT01261975|EG001|Reported Event|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
11041997|NCT01261975|EG002|Reported Event|Cataract Surgery All Participants|Events by participant one eye with 1.8 mm coaxial micro-incision cataract surgery (C-MICS) and the contralateral eye with the 2.75 mm coaxial standard cataract surgery.
11041998|NCT01262027|BG000|Baseline|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
11041999|NCT01262027|FG000|Participant Flow|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
11042000|NCT01262027|OG000|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
11042001|NCT01262027|EG000|Reported Event|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
11042002|NCT01262092|BG000|Baseline|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
11042003|NCT01262092|BG001|Baseline|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
11042004|NCT01262092|BG002|Baseline|Total|Total of all reporting groups
11042005|NCT01262092|FG000|Participant Flow|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
11042006|NCT01262092|FG001|Participant Flow|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
11042007|NCT01262092|OG000|Outcome|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
11042008|NCT01262092|OG001|Outcome|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
11042009|NCT01262092|EG000|Reported Event|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
11042010|NCT01262092|EG001|Reported Event|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
11042011|NCT01262105|BG000|Baseline|No Device|
11042012|NCT01262105|BG001|Baseline|Device Deployed|
11042013|NCT01262105|BG002|Baseline|Total|Total of all reporting groups
11042014|NCT01262105|FG000|Participant Flow|No Device|
11042015|NCT01262105|FG001|Participant Flow|Device Deployed|
11042016|NCT01262105|OG000|Outcome|No Device|No device is deployed during surgery
11042017|NCT01262105|OG001|Outcome|Device Deployed|The ABS device is employed during surgery.
11042018|NCT01262105|EG000|Reported Event|No Device|
11042019|NCT01262105|EG001|Reported Event|Device Deployed|
11042020|NCT01262118|BG000|Baseline|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
11042021|NCT01262118|BG001|Baseline|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
11042022|NCT01262118|BG002|Baseline|Total|Total of all reporting groups
11042023|NCT01262118|FG000|Participant Flow|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
11042024|NCT01262118|FG001|Participant Flow|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
11042025|NCT01262118|OG000|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
11042026|NCT01262118|OG001|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
11042027|NCT01262118|EG000|Reported Event|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
11042028|NCT01262118|EG001|Reported Event|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
11042029|NCT01262131|BG000|Baseline|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
11042030|NCT01262131|BG001|Baseline|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
11042031|NCT01262131|BG002|Baseline|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
11042032|NCT01262131|BG003|Baseline|Total|Total of all reporting groups
11042033|NCT01262131|FG000|Participant Flow|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
11042034|NCT01262131|FG001|Participant Flow|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
11042035|NCT01262131|FG002|Participant Flow|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
11042036|NCT01262131|OG000|Outcome|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
11042037|NCT01262131|OG001|Outcome|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
11042038|NCT01262131|OG002|Outcome|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
11042039|NCT01262131|EG000|Reported Event|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
11042040|NCT01262131|EG001|Reported Event|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
11042041|NCT01262131|EG002|Reported Event|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
11042042|NCT01262287|BG000|Baseline|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
11042043|NCT01262287|BG001|Baseline|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
11042044|NCT01262287|BG002|Baseline|Total|Total of all reporting groups
11042045|NCT01262287|FG000|Participant Flow|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
11042046|NCT01262287|FG001|Participant Flow|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
11042047|NCT01262287|OG000|Outcome|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
11042048|NCT01262287|OG001|Outcome|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
11042049|NCT01262287|OG000|Outcome|AKR1C3*2 C/C Genotype + Dutasteride|AKR1C3*2 C/C genotype subjects in dutasteride arm (1 mg daily for 8 wks)
11042050|NCT01262287|OG001|Outcome|AKR1C3*2 C/C Genotype + Placebo|"AKR1C3*2 C/C genotype subjects in placebo arm~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
11042051|NCT01262287|OG002|Outcome|AKR1C3*2 G-carriers + Dutasteride|AKR1C3*2 G-carriers in dutasteride arm (1 mg/day x 8 wks)
11042052|NCT01262287|OG003|Outcome|AKR1C3*2 G-carriers + Placebo|AKR1C3*2 G-carriers in placebo arm
11042053|NCT01262287|EG000|Reported Event|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
11042054|NCT01262287|EG001|Reported Event|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
11042055|NCT01262352|BG000|Baseline|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
11042056|NCT01262352|BG001|Baseline|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
11042057|NCT01262352|BG002|Baseline|Total|Total of all reporting groups
11042058|NCT01262352|FG000|Participant Flow|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
11042059|NCT01262352|FG001|Participant Flow|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
11042060|NCT01262352|OG000|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
11042061|NCT01262352|OG001|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
11042062|NCT01262352|EG000|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
11042063|NCT01262352|EG001|Reported Event|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
11042064|NCT01262365|BG000|Baseline|Placebo (Weekly Infusion)|Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
11042065|NCT01262365|BG001|Baseline|Epratuzumab 1200 mg Every Other Week|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
11042066|NCT01262365|BG002|Baseline|Epratuzumab 600 mg Per Week|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
11042067|NCT01262365|BG003|Baseline|Total Title|
11042068|NCT01262365|FG000|Participant Flow|Placebo (RS)|Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
11042069|NCT01262365|FG001|Participant Flow|Epratuzumab 1200 mg Every Other Week (RS)|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
11042070|NCT01262365|FG002|Participant Flow|Epratuzumab 600 mg Per Week (RS)|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
11042071|NCT01262365|OG000|Outcome|Placebo (Weekly Infusion) FAS|Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
11042072|NCT01262365|OG001|Outcome|Epratuzumab 1200 mg Every Other Week (FAS)|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
11042073|NCT01262365|OG002|Outcome|Epratuzumab 600 mg Per Week (FAS)|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
11042074|NCT01262365|EG000|Reported Event|Placebo (Weekly Infusion)|Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
11042075|NCT01262365|EG001|Reported Event|Epratuzumab 1200 mg Every Other Week|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
11042076|NCT01262365|EG002|Reported Event|Epratuzumab 600 mg Per Week|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
11042077|NCT01262456|BG000|Baseline|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042078|NCT01262456|BG001|Baseline|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042079|NCT01262456|BG002|Baseline|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042080|NCT01262456|BG003|Baseline|Total|Total of all reporting groups
11042081|NCT01262456|FG000|Participant Flow|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
11042082|NCT01262456|FG001|Participant Flow|50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
11042083|NCT01262456|FG002|Participant Flow|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
11042084|NCT01262456|OG000|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042085|NCT01262456|OG001|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042086|NCT01262456|OG002|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042087|NCT01262456|OG000|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042088|NCT01262456|OG002|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042089|NCT01262456|OG000|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
11042090|NCT01262456|OG001|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
11042091|NCT01262456|OG002|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
11226311|NCT02373813|OG002|Outcome|Double-Blind Treatment: Etanercept Plus Methotrexate|"Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment)."
11042092|NCT01262456|EG000|Reported Event|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042093|NCT01262456|EG001|Reported Event|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042094|NCT01262456|EG002|Reported Event|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
11042095|NCT01262456|EG003|Reported Event|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
11042096|NCT01262456|EG004|Reported Event|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
11042097|NCT01262456|EG005|Reported Event|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
11042098|NCT01262547|BG000|Baseline|All Study Participants|"Dermabrasion-Micrografting, Dermabrasion and Control~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.~Control: Untreated depigmented area"
11042099|NCT01262547|FG000|Participant Flow|Patients With Vitiligo|Three subjects with vitiligo were recruited for the study. All subjects had three test sites that were studied. One site received dermabrasion and micrografting, one site received dermabrasion alone and one site was not treated and served as the control.
11042100|NCT01262547|OG000|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
11042101|NCT01262547|OG001|Outcome|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
11042102|NCT01262547|OG002|Outcome|Control|Target sites did not receive any treatment
11042103|NCT01262547|OG002|Outcome|Control|Control
11226312|NCT02373813|EG000|Reported Event|Open Label Run-In: Etanercept Plus Methotrexate|Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care.
11042104|NCT01262547|EG000|Reported Event|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
11042105|NCT01262547|EG001|Reported Event|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
11042106|NCT01262547|EG002|Reported Event|Control|"Control~Depigmented areas that did not receive any treatment."
11066553|NCT01392963|EG000|Reported Event|Botox, Then Placebo|At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).
11066554|NCT01392963|EG001|Reported Event|Placebo, Then Botox|At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).
11066555|NCT01392989|BG000|Baseline|Allogeneic Cytokine Induced Killer Cells (CIK)|"Target dose of ≥ 5 x 106 CD34+ cells/kg of recipient body weight plus an additional 2 x109 mononuclear cells.~CIK cells: Standard of care~Cyclosporine: 5 mg/kg, po~Mycophenolate Mofetil: 15 mg/kg, oral~Thymoglobulin: 7.5 mg/kg, IV"
11066556|NCT01392989|FG000|Participant Flow|Allogeneic Cytokine Induced Killer Cells (CIK)|"Target dose of ≥ 5 x 106 CD34+ cells/kg of recipient body weight plus an additional 2 x109 mononuclear cells.~CIK cells: Standard of care~Cyclosporine: 5 mg/kg, po~Mycophenolate Mofetil: 15 mg/kg, oral~Thymoglobulin: 7.5 mg/kg, IV"
11066557|NCT01392989|OG000|Outcome|Allogeneic Cytokine Induced Killer Cells (CIK)|"Target dose of ≥ 5 x 106 CD34+ cells/kg of recipient body weight plus an additional 2 x109 mononuclear cells.~CIK cells: Standard of care~Cyclosporine: 5 mg/kg, po~Mycophenolate Mofetil: 15 mg/kg, oral~Thymoglobulin: 7.5 mg/kg, IV"
11066558|NCT01392989|OG000|Outcome|Allogeneic Cytokine Induced Killer Cells (CIK)|"Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.~CIK cells: Standard of care~Cyclosporine: 5 mg/kg, po~Mycophenolate Mofetil: 15 mg/kg, oral~Thymoglobulin: 7.5 mg/kg, IV"
11066559|NCT01392989|EG000|Reported Event|Allogeneic Cytokine Induced Killer Cells (CIK)|"Target dose of ≥ 5 x 106 CD34+ cells/kg of recipient body weight plus an additional 2 x109 mononuclear cells.~CIK cells: Standard of care~Cyclosporine: 5 mg/kg, po~Mycophenolate Mofetil: 15 mg/kg, oral~Thymoglobulin: 7.5 mg/kg, IV"
11066560|NCT01393106|BG000|Baseline|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
11066561|NCT01393106|FG000|Participant Flow|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
11066562|NCT01393106|OG000|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
11066563|NCT01393106|EG000|Reported Event|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
11066564|NCT01393132|BG000|Baseline|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
11066565|NCT01393132|BG001|Baseline|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
11066566|NCT01393132|BG002|Baseline|Total|Total of all reporting groups
10848945|NCT00292942|OG002|Outcome|8 mg/kg Intravenous Artesunate|"8 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11066567|NCT01393132|FG000|Participant Flow|Thymosin|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial~Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.~Period Title * Participant Flow: Overall Study~Placebo Thymosin Beta 4 Started 3 6 Completed 3 6"
11066568|NCT01393132|FG001|Participant Flow|Placebo|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial~Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days."
11066569|NCT01393132|OG000|Outcome|Thymosin|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
11066570|NCT01393132|OG001|Outcome|Placebo|Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
11066571|NCT01393132|OG000|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
10848946|NCT00292942|EG000|Reported Event|Placebo|"Mannitol (200 mg/vial) diluted in phosphate buffer and delivered in an equivalent volume by subject's weight as artesunate.~Placebo: Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight."
11066572|NCT01393132|OG001|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
11066573|NCT01393132|EG000|Reported Event|Thymosin Beta 4|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
11042107|NCT01262560|BG000|Baseline|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
11042108|NCT01262560|BG001|Baseline|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
11042109|NCT01262560|BG002|Baseline|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
11042110|NCT01262560|BG003|Baseline|Total|Total of all reporting groups
11042111|NCT01262560|FG000|Participant Flow|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
11042112|NCT01262560|FG001|Participant Flow|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
11042113|NCT01262560|FG002|Participant Flow|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
11042114|NCT01262560|OG000|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
11042115|NCT01262560|OG001|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
11042116|NCT01262560|OG002|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
11042117|NCT01262560|EG000|Reported Event|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
11042118|NCT01262560|EG001|Reported Event|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
11042119|NCT01262560|EG002|Reported Event|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
11042120|NCT01262573|BG000|Baseline|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
11042121|NCT01262573|BG001|Baseline|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
11042122|NCT01262573|BG002|Baseline|Total|Total of all reporting groups
11042123|NCT01262573|FG000|Participant Flow|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
11042124|NCT01262573|FG001|Participant Flow|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
11042125|NCT01262573|OG000|Outcome|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
11042126|NCT01262573|OG001|Outcome|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
11042127|NCT01262573|EG000|Reported Event|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
11042128|NCT01262573|EG001|Reported Event|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
11042129|NCT01262599|BG000|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
11042130|NCT01262599|BG001|Baseline|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
11042131|NCT01262599|BG002|Baseline|Total|Total of all reporting groups
11042132|NCT01262599|FG000|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
11042133|NCT01262599|FG001|Participant Flow|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
11042134|NCT01262599|OG000|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
11042135|NCT01262599|OG001|Outcome|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
11042136|NCT01262599|OG000|Outcome|Sham PEMF Device|"Patients will receive inactive device~Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields"
11042137|NCT01262599|OG001|Outcome|PEMF Device|"Patients will receive Ivivi Torino II PEMF Device~Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours. Supplied by Ivivi Health Sciences, LLC."
11042138|NCT01262599|EG000|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
11042139|NCT01262599|EG001|Reported Event|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
11042140|NCT01262638|BG000|Baseline|ETC-1002 40 mg|Participants received ETC-1002 40 milligrams (mg), orally, once daily for 12 weeks.
11042141|NCT01262638|BG001|Baseline|ETC-1002 80 mg|Participants received ETC-1002 80 mg, orally, once daily for 12 weeks.
11042142|NCT01262638|BG002|Baseline|ETC-1002 120 mg|Participants received ETC-1002 120 mg, orally, once daily for 12 weeks.
11042143|NCT01262638|BG003|Baseline|Placebo|Participants received placebo, orally, once daily for 12 weeks.
11042144|NCT01262638|BG004|Baseline|Total|Total of all reporting groups
11042145|NCT01262638|FG000|Participant Flow|ETC-1002 40 mg|Participants received ETC-1002 40 milligrams (mg), orally, once daily for 12 weeks.
11042146|NCT01262638|FG001|Participant Flow|ETC-1002 80 mg|Participants received ETC-1002 80 mg, orally, once daily for 12 weeks.
11042147|NCT01262638|FG002|Participant Flow|ETC-1002 120 mg|Participants received ETC-1002 120 mg, orally, once daily for 12 weeks.
11042148|NCT01262638|FG003|Participant Flow|Placebo|Participants received placebo, orally, once daily for 12 weeks.
11042149|NCT01262638|OG000|Outcome|ETC-1002 40 mg|Participants received ETC-1002 40 milligrams (mg), orally, once daily for 12 weeks.
11042150|NCT01262638|OG001|Outcome|ETC-1002 80 mg|Participants received ETC-1002 80 mg, orally, once daily for 12 weeks.
11042151|NCT01262638|OG002|Outcome|ETC-1002 120 mg|Participants received ETC-1002 120 mg, orally, once daily for 12 weeks.
11042152|NCT01262638|OG003|Outcome|Placebo|Participants received placebo, orally, once daily for 12 weeks.
11042153|NCT01262638|OG000|Outcome|ETC-1002 40 mg|Participants received ETC-1002 40 mg, orally, once daily for 12 weeks.
11042154|NCT01262638|OG001|Outcome|ETC-1002 80 mg|Participants received ETC-1002 80 mg, orally, once daily for 12 weeks
11042155|NCT01262638|OG001|Outcome|ETC-1002 80 mg|Participants received ETC-1002 80 mg, orally, once daily for 12 weeks..
11042156|NCT01262638|EG000|Reported Event|ETC-1002 40 mg|Participants received ETC-1002 40 mg, orally, once daily for 12 weeks.
11042157|NCT01262638|EG001|Reported Event|ETC-1002 80 mg|Participants received ETC-1002 80 mg, orally, once daily for 12 weeks.
11042158|NCT01262638|EG002|Reported Event|ETC-1002 120 mg|Participants received ETC-1002 120 mg, orally, once daily for 12 weeks.
11042159|NCT01262638|EG003|Reported Event|Placebo|Participants received placebo, orally, once daily for 12 weeks.
11042160|NCT01262651|BG000|Baseline|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11042161|NCT01262651|BG001|Baseline|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
11042162|NCT01262651|BG002|Baseline|Total|Total of all reporting groups
11042163|NCT01262651|FG000|Participant Flow|Nabiximols|Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11042164|NCT01262651|FG001|Participant Flow|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
11042165|NCT01262651|OG000|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11042166|NCT01262651|OG001|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
11042167|NCT01262651|EG000|Reported Event|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11042168|NCT01262651|EG001|Reported Event|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
11042169|NCT01262677|BG000|Baseline|Pregabalin 165 mg|After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042170|NCT01262677|BG001|Baseline|Pregabalin 330 mg|After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042171|NCT01262677|BG002|Baseline|Placebo|After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042172|NCT01262677|BG003|Baseline|Total|Total of all reporting groups
11066574|NCT01393132|EG001|Reported Event|Placebo|: A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
11066575|NCT01393158|BG000|Baseline|Apremilast 20mg|Apremilast: 20 mg by mouth twice daily for a total of 12 weeks.
11042173|NCT01262677|FG000|Participant Flow|Pregabalin 165 mg|After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hour (hr) after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042174|NCT01262677|FG001|Participant Flow|Pregabalin 330 mg|After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042175|NCT01262677|FG002|Participant Flow|Placebo|After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042176|NCT01262677|OG000|Outcome|Pregabalin 165 mg|After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042177|NCT01262677|OG001|Outcome|Pregabalin 330 mg|After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042178|NCT01262677|OG002|Outcome|Placebo|After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042179|NCT01262677|EG000|Reported Event|Pregabalin 165 mg|After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042180|NCT01262677|EG001|Reported Event|Pregabalin 330 mg|After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042181|NCT01262677|EG002|Reported Event|Placebo|After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
11042182|NCT01262755|BG000|Baseline|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
10848947|NCT00292942|EG001|Reported Event|2 mg/kg Intravenous Artesunate|"2 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11042183|NCT01262755|FG000|Participant Flow|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
11042184|NCT01262755|OG000|Outcome|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
11042185|NCT01262755|EG000|Reported Event|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
11042186|NCT01262820|BG000|Baseline|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
11042187|NCT01262820|FG000|Participant Flow|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
11042188|NCT01262820|OG000|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
11042189|NCT01262820|EG000|Reported Event|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
11042190|NCT01262846|BG000|Baseline|Fluzone SD|"Fluzone® Standard dose~Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
11042191|NCT01262846|BG001|Baseline|Fluzone® High Dose|"Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.~Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
11042192|NCT01262846|BG002|Baseline|Total|Total of all reporting groups
11066576|NCT01393158|BG001|Baseline|Apremilast 30mg|Apremilast: 30 mg by mouth twice daily for a total of 24 weeks.
11042193|NCT01262846|FG000|Participant Flow|Fluzone SD|"Fluzone® Standard dose~Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
11042194|NCT01262846|FG001|Participant Flow|Fluzone® High Dose|"Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.~Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
11042195|NCT01262846|OG000|Outcome|SD Recipients|Fluzone Regular Dose
11042196|NCT01262846|OG001|Outcome|HD Recipients|Fluzone High Dose
11042197|NCT01262846|EG000|Reported Event|SD Recipients|
11042198|NCT01262846|EG001|Reported Event|HD Recipients|
11042199|NCT01262872|BG000|Baseline|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
11042200|NCT01262872|BG001|Baseline|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
11042201|NCT01262872|BG002|Baseline|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042202|NCT01262872|BG003|Baseline|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042203|NCT01262872|BG004|Baseline|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042204|NCT01262872|BG005|Baseline|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042205|NCT01262872|BG006|Baseline|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042206|NCT01262872|BG007|Baseline|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042207|NCT01262872|BG008|Baseline|Total|Total of all reporting groups
11042208|NCT01262872|FG000|Participant Flow|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
11066577|NCT01393158|BG002|Baseline|Total|Total of all reporting groups
11066578|NCT01393158|FG000|Participant Flow|Apremilast 20mg|Apremilast: 20 mg by mouth twice daily for a total of 12 weeks.
11042209|NCT01262872|FG001|Participant Flow|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
11042210|NCT01262872|FG002|Participant Flow|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042211|NCT01262872|FG003|Participant Flow|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042212|NCT01262872|FG004|Participant Flow|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042213|NCT01262872|FG005|Participant Flow|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042214|NCT01262872|FG006|Participant Flow|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042215|NCT01262872|FG007|Participant Flow|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042216|NCT01262872|OG000|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
11042217|NCT01262872|OG001|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
11042218|NCT01262872|OG001|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
11066579|NCT01393158|FG001|Participant Flow|Apremilast 30mg|Apremilast: 30 mg by mouth twice daily for a total of 24 weeks.
11066580|NCT01393158|OG000|Outcome|Apremilast 20 BID|Subjects received 20mg of Apremilast BID for 12 weeks
11066581|NCT01393158|OG001|Outcome|Apremilast 30mg BID|Subjects received 30mg of Apremilast BID for 24 weeks
11066582|NCT01393158|OG000|Outcome|Apremilast 20 BID|Subjects received 20mg BID for 12 weeks
11066583|NCT01393158|OG001|Outcome|Apremilast 30 BID|Subjects received 30mg of Apremilast BID for 24 weeks
11066584|NCT01393158|OG000|Outcome|Apremilast 20mg BID|Subjects received 20mg BID
11042219|NCT01262872|OG000|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042220|NCT01262872|OG001|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042221|NCT01262872|OG002|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042222|NCT01262872|OG000|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042223|NCT01262872|OG001|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042224|NCT01262872|OG000|Outcome|10PP-HD 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
11042225|NCT01262872|OG001|Outcome|Prevnar13 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
11042226|NCT01262872|OG000|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
11042227|NCT01262872|OG003|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042228|NCT01262872|OG000|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11066585|NCT01393158|OG001|Outcome|Apremilast 30mg BID|Subjects received 30 mg BID
11066586|NCT01393158|OG000|Outcome|Apremilast 20 BID|Subjects received 20mg Apremilast BID
11066587|NCT01393158|OG001|Outcome|Apremilast 30mg BID|Subjects received 30mg Apremilast BID
11066588|NCT01393158|EG000|Reported Event|Apremalist 20mg BID|Patients receiving 20mg BID for 12 weeks
11042229|NCT01262872|OG001|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042230|NCT01262872|OG000|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042231|NCT01262872|OG000|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
11042232|NCT01262872|OG002|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
11042233|NCT01262872|OG001|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
11042234|NCT01262872|OG003|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042235|NCT01262872|OG000|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042236|NCT01262872|OG001|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042237|NCT01262872|OG000|Outcome|"Total All 5 Group"|A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded).
11066589|NCT01393158|EG001|Reported Event|Apremalist 30mg BID|Patients receiving 30mg BID for 24 weeks
11042238|NCT01262872|OG003|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042239|NCT01262872|OG004|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042240|NCT01262872|EG000|Reported Event|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
11042241|NCT01262872|EG001|Reported Event|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
11042242|NCT01262872|EG002|Reported Event|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042243|NCT01262872|EG003|Reported Event|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042244|NCT01262872|EG004|Reported Event|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042245|NCT01262872|EG005|Reported Event|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042246|NCT01262872|EG006|Reported Event|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11066590|NCT01393301|BG000|Baseline|Behavioral Intervention Arm|"Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.~Integrated cognitive-behavioral therapy for smoking cessation and anxiety: Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress."
11066591|NCT01393301|BG001|Baseline|Control Arm|"Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).~Control: Enhanced standard smoking cessation treatment and NRT."
11066592|NCT01393301|BG002|Baseline|Total|Total of all reporting groups
11042247|NCT01262872|EG007|Reported Event|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
11042248|NCT01262898|BG000|Baseline|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
11042249|NCT01262898|BG001|Baseline|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
11042250|NCT01262898|BG002|Baseline|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
11042251|NCT01262898|BG003|Baseline|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
11042252|NCT01262898|BG004|Baseline|Total|Total of all reporting groups
11042253|NCT01262898|FG000|Participant Flow|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
11042254|NCT01262898|FG001|Participant Flow|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
11042255|NCT01262898|FG002|Participant Flow|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
11042256|NCT01262898|FG003|Participant Flow|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
11042257|NCT01262898|OG000|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
11042258|NCT01262898|OG001|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
11042259|NCT01262898|OG002|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
11042260|NCT01262898|OG003|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
11042261|NCT01262898|OG000|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
11042262|NCT01262898|OG001|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
11042263|NCT01262898|OG002|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
11042264|NCT01262898|EG000|Reported Event|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
11042265|NCT01262898|EG001|Reported Event|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
11042266|NCT01262898|EG002|Reported Event|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
11042267|NCT01262898|EG003|Reported Event|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
11042268|NCT01262976|BG000|Baseline|HIV(+)-HA/GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042269|NCT01262976|BG001|Baseline|HIV(+)HA-/Placebo|HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042270|NCT01262976|BG002|Baseline|HIV(+)-TN/GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042271|NCT01262976|BG003|Baseline|HIV(+)-TN/Placebo|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042272|NCT01262976|BG004|Baseline|HIV(-)/GSK692342|Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042273|NCT01262976|BG005|Baseline|HIV(-)/Placebo|Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042274|NCT01262976|BG006|Baseline|Total|Total of all reporting groups
11042275|NCT01262976|FG000|Participant Flow|HIV(+)-HA/GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042276|NCT01262976|FG001|Participant Flow|HIV(+)-HA/Placebo|HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042277|NCT01262976|FG002|Participant Flow|HIV(+)-TN/GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042278|NCT01262976|FG003|Participant Flow|HIV(+)-TN/Placebo|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042279|NCT01262976|FG004|Participant Flow|HIV(-)/GSK692342|Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042280|NCT01262976|FG005|Participant Flow|HIV(-)/Placebo|Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042281|NCT01262976|OG000|Outcome|HIV(+)-HA/GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042282|NCT01262976|OG001|Outcome|HIV(+)-HA/Placebo|HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042283|NCT01262976|OG002|Outcome|HIV(+)-TN/ GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042284|NCT01262976|OG003|Outcome|HIV(+)-TN/Placebo|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042285|NCT01262976|OG004|Outcome|HIV(-)/GSK692342|Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042286|NCT01262976|OG005|Outcome|HIV(-)/Placebo|Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042287|NCT01262976|OG002|Outcome|HIV(+)-TN/GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042288|NCT01262976|EG000|Reported Event|HIV(+)-HA/GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042289|NCT01262976|EG001|Reported Event|HIV(+)-HA/Placebo|HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042290|NCT01262976|EG002|Reported Event|HIV(+)-TN/GSK692342|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042291|NCT01262976|EG003|Reported Event|HIV(+)-TN/Placebo|HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042292|NCT01262976|EG004|Reported Event|HIV(-)/GSK692342|Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042293|NCT01262976|EG005|Reported Event|HIV(-)/Placebo|Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
11042294|NCT01262989|BG000|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days) or reference product in Period 1 and test product in Period 2
11042295|NCT01262989|FG000|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
11042296|NCT01262989|FG001|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
11042297|NCT01262989|OG000|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
11042298|NCT01262989|OG001|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
11042299|NCT01262989|EG000|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
11042300|NCT01262989|EG001|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
11042301|NCT01263015|BG000|Baseline|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
11042302|NCT01263015|BG001|Baseline|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
11042303|NCT01263015|BG002|Baseline|Total|Total of all reporting groups
11042304|NCT01263015|FG000|Participant Flow|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks.
11042305|NCT01263015|FG001|Participant Flow|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks.
11042306|NCT01263015|OG000|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
11042307|NCT01263015|OG001|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
11042308|NCT01263015|EG000|Reported Event|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
11042309|NCT01263015|EG001|Reported Event|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
11042310|NCT01263054|BG000|Baseline|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
11042311|NCT01263054|BG001|Baseline|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
11042312|NCT01263054|BG002|Baseline|Total|Total of all reporting groups
11042313|NCT01263054|FG000|Participant Flow|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
11042314|NCT01263054|FG001|Participant Flow|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
11042315|NCT01263054|OG000|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
11042316|NCT01263054|OG001|Outcome|Medical Management|Standard Medical Management
11042317|NCT01263054|EG000|Reported Event|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
11042318|NCT01263054|EG001|Reported Event|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
11042319|NCT01263093|BG000|Baseline|Clopidogrel First, Then LY2216684 + Clopidogrel|"Period 1: a single 300-milligram (mg) dose of clopidogrel administered orally on Day 1 (Treatment 1).~Period 2: an 18-mg dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2).~There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2."
11042320|NCT01263093|BG001|Baseline|LY2216684 + Clopidogrel First, Then Clopidogrel|"Period 1: an 18-milligram (mg) dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2).~Period 2: a single 300-mg dose of clopidogrel administered orally on Day 1 (Treatment 1).~There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2."
11042321|NCT01263093|BG002|Baseline|Total|Total of all reporting groups
11042322|NCT01263093|FG000|Participant Flow|Clopidogrel First, Then LY2216684 + Clopidogrel|"Period 1: a single 300-milligram (mg) dose of clopidogrel administered orally on Day 1 (Treatment 1).~Period 2: an 18-mg dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2).~There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2."
11042323|NCT01263093|FG001|Participant Flow|LY2216684 + Clopidogrel First, Then Clopidogrel|"Period 1: an 18-milligram (mg) dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2).~Period 2: a single 300-mg dose of clopidogrel administered orally on Day 1 (Treatment 1).~There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2."
11042324|NCT01263093|OG000|Outcome|Clopidogrel|Clopidogrel: a single 300-milligram (mg) dose, administered orally on Day 1 of Treatment 1
11042325|NCT01263093|OG001|Outcome|LY2216684 + Clopidogrel|"LY2216684: 18-milligram (mg) dose, administered orally, once daily (QD) on Days 1 through 3 of Treatment 2~Clopidogrel: a single 300-mg dose, administered orally on Day 3 of Treatment 2"
11042326|NCT01263093|EG000|Reported Event|Clopidogrel|"Clopidogrel: a single 300-milligram (mg) dose, administered orally on Day 1~Time Frame: Treatment 1"
11042327|NCT01263093|EG001|Reported Event|LY2216684|"LY2216684: 18-milligram (mg) dose, administered orally, once daily (QD) on Days 1 through 3~Time Frame: Treatment 2; prior to clopidogrel dose on Day 3"
11042328|NCT01263093|EG002|Reported Event|LY2216684 + Clopidogrel|"LY2216684: 18-milligram (mg) dose, administered orally, once daily (QD) on Days 1 through 3~Clopidogrel: a single 300-mg dose, administered orally on Day 3~Time Frame: Treatment 2; after the clopidogrel dose on Day 3"
11042329|NCT01263106|BG000|Baseline|All Participants|All started participants.
11042330|NCT01263106|FG000|Participant Flow|Theophylline Alone, Then LY2216684 + Theophylline|Period 1: single 200 mg theophylline oral dose on Day 1; Washout period of at least 7 days; Period 2: 18 mg LY2216684 orally once daily on Days 1-5. Single dose of 200 mg theophylline coadministered on Day 3.
11042331|NCT01263106|FG001|Participant Flow|LY2216684 + Theophylline, Then Theophylline Alone|Period 1: 18 mg LY2216684 orally once daily on Days 1-5. Single dose of 200 mg theophylline coadministered on Day 3.Washout period of at least 7 days; Period 2: single 200 mg theophylline oral dose on Day 1
11042332|NCT01263106|OG000|Outcome|Theophylline Alone|Single 200 mg theophylline oral dose on Day 1.
11042333|NCT01263106|OG001|Outcome|LY2216684 + Theophylline|Oral dose of 18 mg LY2216684, once daily on Days 1-5 with single 200 mg theophylline dose coadministered on Day 3.
11042334|NCT01263106|OG000|Outcome|Theophylline|Single 200 mg theophylline oral dose on Day 1.
11042335|NCT01263106|OG000|Outcome|18 mg LY2216684 + 200 mg Theophylline|Oral dose of 18 mg LY2216684, once daily on Days 1-5 with single 200 mg theophylline dose coadministered on Day 3.
11042336|NCT01263106|EG000|Reported Event|LY2216684|18 mg LY2216684 orally
11042337|NCT01263106|EG001|Reported Event|Theophylline|single 200-mg theophylline oral dose
11042338|NCT01263106|EG002|Reported Event|LY2216684 + Theophylline|18 mg LY2216684 orally with single 200-mg theophylline oral dose coadministered
11042339|NCT01263119|BG000|Baseline|Warfarin, LY2216684 + Warfarin|Period 1: Single 10-milligram (mg) warfarin oral dose on Day 1; Washout Period of at least 14 days; Period 2: 18-mg LY2216684 oral dose, once daily on Days 1 to 12, with single 10-mg warfarin oral dose coadministered on Day 3.
11042340|NCT01263119|FG000|Participant Flow|Warfarin, LY2216684 + Warfarin|Period 1: Single 10-milligram (mg) warfarin oral dose on Day 1; Washout Period of at least 14 days; Period 2: 18-mg LY2216684 oral dose, once daily on Days 1 to 12, with single 10-mg warfarin oral dose coadministered on Day 3.
11042341|NCT01263119|OG000|Outcome|10 mg Warfarin + 18 mg LY2216684 (Test)|Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
11042342|NCT01263119|OG001|Outcome|10 mg Warfarin Alone (Reference)|Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
11042343|NCT01263119|OG001|Outcome|10 mg Warfarin Alone (Reference)|Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
11042344|NCT01263119|EG000|Reported Event|10 mg Warfarin + 18 mg LY2216684 (Test)|Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
11042345|NCT01263119|EG001|Reported Event|10 mg Warfarin Alone (Reference)|Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
11042346|NCT01263119|EG002|Reported Event|18 mg LY2216684 Alone|Period 2: 18-mg LY2216684 oral dose, once daily on Days 1 to 12.
11042347|NCT01263132|BG000|Baseline|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
11042348|NCT01263132|BG001|Baseline|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
11042349|NCT01263132|BG002|Baseline|Total|Total of all reporting groups
11042350|NCT01263132|FG000|Participant Flow|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
11042351|NCT01263132|FG001|Participant Flow|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
11042352|NCT01263132|OG000|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
11042353|NCT01263132|OG001|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
11042354|NCT01263132|EG000|Reported Event|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
11042355|NCT01263132|EG001|Reported Event|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
11042356|NCT01263197|BG000|Baseline|Group 1, Any Sequence (LY2216684, Albuterol, or Placebo)|"Participants were administered LY2216684, albuterol, or placebo during Periods 1, 2, and 3.~LY2216684 or placebo was administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 of each period.~Albuterol or placebo was co-administered as a 2-mg oral dose (one 2-mg tablet) QD on Days 1, 3, and 5 of each period."
11042357|NCT01263197|BG001|Baseline|Group 2, Any Sequence (LY2216684, Propranolol, or Placebo)|"Participants were administered LY2216684, propranolol, or placebo during Periods 1, 2, and 3.~LY2216684 or placebo was administered as an 18-milligram (mg) oral dose (two 9-mg tablets) QD on Days 1 through 5 of each period.~Propranolol or placebo was co-administered as a 40-mg oral dose (one 40-mg tablet) QD on Days 1, 3, and 5 of each period."
11042358|NCT01263197|BG002|Baseline|Total|Total of all reporting groups
11042359|NCT01263197|FG000|Participant Flow|Group 1, Seq 1: LY2216684, Albuterol, LY2216684+Albuterol|"Group 1, Sequence (Seq) 1~First intervention: LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.~Second intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.~Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.~There was a minimum 7-day washout between each intervention period."
11042360|NCT01263197|FG001|Participant Flow|Group 1, Seq 2: Albuterol, LY2216684+Albuterol, LY2216684|"Group 1, Sequence 2~First intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.~Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.~Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.~There was a minimum 7-day washout between each intervention period."
11042361|NCT01263197|FG002|Participant Flow|Group 1, Seq 3: LY2216684+Albuterol, LY2216684, Albuterol|"Group 1, Sequence 3~First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.~Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.~Third intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.~There was a minimum 7-day washout between each intervention period."
11042362|NCT01263197|FG003|Participant Flow|Group 2, Seq 1: LY2216684, Propranolol, LY2216684+Propranolol|"Group 2, Sequence 1~First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.~Second intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.~Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.~There was a minimum 7-day washout between each intervention period."
11042363|NCT01263197|FG004|Participant Flow|Group 2, Seq 2: Propranolol, LY2216684+Propranolol, LY2216684|"Group 2, Sequence 2~First intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.~Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.~Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.~There was a minimum 7-day washout between each intervention period."
11042364|NCT01263197|FG005|Participant Flow|Group 2, Seq 3: LY2216684+Propranolol, LY2216684, Propranolol|"Group 2, Sequence 3~First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.~Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.~Third intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.~There was a minimum 7-day washout between each intervention period."
11042365|NCT01263197|OG000|Outcome|LY2216684 (Group 1)|Participants randomized to Group 1 who received LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5 in any treatment period.
11042366|NCT01263197|OG001|Outcome|Albuterol|Participants randomized to Group 1 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
11042367|NCT01263197|OG002|Outcome|LY2216684+Albuterol|Participants randomized to Group 1 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
11042368|NCT01263197|OG003|Outcome|LY2216684 (Group 2)|Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5 in any treatment period.
11042369|NCT01263197|OG004|Outcome|Propranolol|Participants randomized to Group 2 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
11042370|NCT01263197|OG005|Outcome|LY2216684+Propranolol|Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
11042371|NCT01263197|EG000|Reported Event|LY2216684 (Group 1)|Participants randomized to Group 1 who received LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5 in any treatment period.
11042372|NCT01263197|EG001|Reported Event|Albuterol|Participants randomized to Group 1 who received who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
11042373|NCT01263197|EG002|Reported Event|LY2216684+Albuterol|Participants randomized to Group 1 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
11042374|NCT01263197|EG003|Reported Event|LY2216684 (Group 2)|Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5 in any treatment period.
11042375|NCT01263197|EG004|Reported Event|Propranolol|Participants randomized to Group 2 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40-mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
11042376|NCT01263197|EG005|Reported Event|LY2216684+Propranolol|Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
11042377|NCT01263223|BG000|Baseline|Overall Study Participants|"Period 1: 18-mg LY2216684 or Placebo administered orally, once daily on Days 1-4.~Period 2: Participants who received LY2216684 in Period 1, then received Placebo administered orally, once daily on Days 1-4 in Period 2. Participants who received Placebo in Period 1, then received 18-mg LY2216684 administered orally, once daily on Days 1-4 in Period 2.~Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4."
11042378|NCT01263223|FG000|Participant Flow|18-mg LY2216684; Placebo; 36-mg LY2216684 or Placebo|"Period 1: 18-milligram (mg) LY2216684 (LY) administered orally once daily on Days 1-4~Period 2: Placebo administered orally, once daily on Days 1-4~Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4"
11042379|NCT01263223|FG001|Participant Flow|Placebo; 18-mg LY2216684; Placebo or 36-mg LY2216684|"Period 1: Placebo administered orally, once daily on Days 1-4~Period 2: 18-mg LY2216684 administered orally, once daily on Days 1-4~Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4"
11042380|NCT01263223|OG000|Outcome|18-mg LY2216684|Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
11042381|NCT01263223|OG001|Outcome|Placebo|Participants received a single, oral dose of Placebo each day over 4 days.
11042382|NCT01263223|OG000|Outcome|36-mg LY2216684|Participants received a single, oral dose of 36-mg LY2216684 each day over 4 days.
11042383|NCT01263223|OG001|Outcome|36-mg LY2216684|Participants received a single, oral dose of 36-mg LY2216684 each day over 4 days.
11042384|NCT01263223|EG000|Reported Event|18-mg LY2216684|Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
11042385|NCT01263223|EG001|Reported Event|36-mg LY2216684|Participants received a single, oral dose of 36-mg LY2216684 each day over 4 days.
11042386|NCT01263223|EG002|Reported Event|Placebo|Participants received a single, oral dose of Placebo each day over 4 days.
11042387|NCT01263301|BG000|Baseline|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
11042388|NCT01263301|BG001|Baseline|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
11042389|NCT01263301|BG002|Baseline|Total|Total of all reporting groups
11042390|NCT01263301|FG000|Participant Flow|Carotid Duplex for Nonhemidialytic Patients Wtih SSS|using carotid duplex to study vertebral and subclavian artery, using cuff test to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test for patients in the two groups
11042391|NCT01263301|FG001|Participant Flow|Carotid Duplex for Hemodialytic Patients|"After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of vertebral artery and subclavian artery in the ipsilateral side of vascular access.~However, before carotid duplex, we didn't know which patients will show SSS.All 11 hemodialytic patients completed the study but only 2 showed the results of SSS. And for further analysis, we used these only 2."
11042392|NCT01263301|OG000|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test
11042393|NCT01263301|OG001|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
11042394|NCT01263301|OG000|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow remained unchanged during the cuff test
11042395|NCT01263301|OG001|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow remained unchanged during the cuff test
11042396|NCT01263301|OG000|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow reversed to normal during the test
11042397|NCT01263301|OG001|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow reversed to normal pattern during the test
11042398|NCT01263301|OG000|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow remained unchanged during the test
11042399|NCT01263301|OG001|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow remained unchanged during the test
11042400|NCT01263301|EG000|Reported Event|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
11042401|NCT01263301|EG001|Reported Event|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
11042402|NCT01263314|BG000|Baseline|Panel A (Elderly Males, Mild/Moderate Hypertension)|MK-8266 (0.3 mg, 0.6 mg, or 0.7 mg and then 0.3 mg after 10 hours) or placebo
11042403|NCT01263314|BG001|Baseline|Panel B (Elderly Females, Mild/Moderate Hypertension)|MK-8266 (0.3 mg, 0.6 mg, or 0.7 mg and then 0.3 mg after 10 hours) or placebo
11042404|NCT01263314|BG002|Baseline|Total|Total of all reporting groups
11042405|NCT01263314|FG000|Participant Flow|Panel A (Elderly Males, Mild/Moderate Hypertension) Sequence 1|Period 1: MK-8266 0.3 mg; Period 2: MK-8266 0.6 mg; and Period 3: placebo.
11042406|NCT01263314|FG001|Participant Flow|Panel A (Elderly Males, Mild/Moderate Hypertension) Sequence 2|Period 1: MK-8266 0.3 mg; Period 2: MK-8266 0.6 mg; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
11042407|NCT01263314|FG002|Participant Flow|Panel A (Elderly Males, Mild/Moderate Hypertension) Sequence 3|Period 1: MK-8266 0.3 mg; Period 2: placebo; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
11042408|NCT01263314|FG003|Participant Flow|Panel A (Elderly Males, Mild/Moderate Hypertension) Sequence 4|Period 1: placebo; Period 2: MK-8266 0.6 mg; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
11042409|NCT01263314|FG004|Participant Flow|Panel B (Elderly Females, Mild/Moderate Hypertension) Seq. 1|Period 1: MK-8266 0.3 mg; Period 2: placebo; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
11042410|NCT01263314|FG005|Participant Flow|Panel B (Elderly Females, Mild/Moderate Hypertension) Seq. 2|Period 1: MK-8266 0.3 mg; Period 2: MK-8266 0.6 mg; and Period 3: placebo.
11042411|NCT01263314|FG006|Participant Flow|Panel B (Elderly Females, Mild/Moderate Hypertension) Seq. 3|Period 1: MK-8266 0.3 mg; Period 2: MK-8266 0.6 mg; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
11042412|NCT01263314|FG007|Participant Flow|Panel B (Elderly Females, Mild/Moderate Hypertension) Seq. 4|Period 1: placebo; Period 2: MK-8266 0.6 mg; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
11042413|NCT01263314|OG000|Outcome|Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)|"MK-8266 single dose 0.3 mg~Hypertension (HTN)"
11042414|NCT01263314|OG001|Outcome|Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)|MK-8266 single dose 0.6 mg
11042415|NCT01263314|OG002|Outcome|Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)|MK-8266 0.7 mg and then 0.3 mg after 10 hours
11042416|NCT01263314|OG003|Outcome|Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)|Placebo to MK-8266 single dose
11042417|NCT01263314|OG004|Outcome|Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)|MK-8266 single dose 0.3 mg
11042418|NCT01263314|OG005|Outcome|Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)|MK-8266 single dose 0.6 mg
11042419|NCT01263314|OG006|Outcome|Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)|MK-8266 0.7 mg and then 0.3 mg after 10 hours
11042420|NCT01263314|OG007|Outcome|Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)|Placebo to MK-8266 single dose
11042421|NCT01263314|OG000|Outcome|Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)|MK-8266 single dose 0.3 mg
11042422|NCT01263314|OG000|Outcome|Panel A MK-8266 0.3 mg (Elderly Males With Mild/Mod. HTN)|MK-8266 single dose 0.3 mg
11042423|NCT01263314|OG001|Outcome|Panel A MK-8266 0.6 mg (Elderly Males With Mild/Mod. HTN)|MK-8266 single dose 0.6 mg
11042424|NCT01263314|OG002|Outcome|Panel A MK-8266 0.7 /0.3 (Elderly Males With Mild/Mod. HTN)|MK-8266 0.7 mg and then 0.3 mg after 10 hours
11042425|NCT01263314|OG003|Outcome|Panel A Placebo to MK-8266 (Elderly Males Mild/Moderate HTN)|Placebo to MK- 8266 single dose
11042426|NCT01263314|OG004|Outcome|Panel B MK-8266 0.3 mg (Elderly Females With Mild/Mod. HTN)|MK-8266 single dose 0.3 mg
11042427|NCT01263314|EG000|Reported Event|Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)|MK-8266 single dose 0.3 mg
11042428|NCT01263314|EG001|Reported Event|Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)|MK-8266 single dose 0.6 mg
11042429|NCT01263314|EG002|Reported Event|Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)|MK-8266 0.7 mg and then 0.3 mg after 10 hours
11042430|NCT01263314|EG003|Reported Event|Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)|Placebo to MK-8266 single dose
11042431|NCT01263314|EG004|Reported Event|Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)|MK-8266 single dose 0.3 mg
11042432|NCT01263314|EG005|Reported Event|Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)|MK-8266 single dose 0.6 mg
11042433|NCT01263314|EG006|Reported Event|Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)|MK-8266 0.7 mg and then 0.3 mg after 10 hours
11042434|NCT01263314|EG007|Reported Event|Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)|Placebo to MK-8266 single dose
11042435|NCT01263444|BG000|Baseline|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
11042436|NCT01263444|FG000|Participant Flow|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
11042437|NCT01263444|OG000|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
11042438|NCT01263444|EG000|Reported Event|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
11042439|NCT01263470|BG000|Baseline|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
11042440|NCT01263470|BG001|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
11042441|NCT01263470|BG002|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
11042442|NCT01263470|BG003|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
11042443|NCT01263470|BG004|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
11042444|NCT01263470|BG005|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042445|NCT01263470|BG006|Baseline|Total|Total of all reporting groups
11042446|NCT01263470|FG000|Participant Flow|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
11042447|NCT01263470|FG001|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
11042448|NCT01263470|FG002|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
11042449|NCT01263470|FG003|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
11042450|NCT01263470|FG004|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
11042451|NCT01263470|FG005|Participant Flow|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042452|NCT01263470|OG000|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
11042453|NCT01263470|OG001|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
11042454|NCT01263470|OG002|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
11042455|NCT01263470|OG003|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
11042456|NCT01263470|OG004|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
11042457|NCT01263470|OG005|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042458|NCT01263470|EG000|Reported Event|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
11042459|NCT01263470|EG001|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
11042460|NCT01263470|EG002|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
11042461|NCT01263470|EG003|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
11042462|NCT01263470|EG004|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
11042463|NCT01263470|EG005|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042464|NCT01263483|BG000|Baseline|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042465|NCT01263483|BG001|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
11042466|NCT01263483|BG002|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042467|NCT01263483|BG003|Baseline|Total|Total of all reporting groups
11042468|NCT01263483|FG000|Participant Flow|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042469|NCT01263483|FG001|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
11042470|NCT01263483|FG002|Participant Flow|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042471|NCT01263483|OG000|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042472|NCT01263483|OG001|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
11042473|NCT01263483|OG002|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042474|NCT01263483|EG000|Reported Event|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042475|NCT01263483|EG001|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
11042476|NCT01263483|EG002|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
11042477|NCT01263496|BG000|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
11042478|NCT01263496|BG001|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
11042479|NCT01263496|BG002|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
11042480|NCT01263496|BG003|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
11042481|NCT01263496|BG004|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042482|NCT01263496|BG005|Baseline|Total|Total of all reporting groups
11042483|NCT01263496|FG000|Participant Flow|Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group|"Alogliptin 6.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 6.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
11042484|NCT01263496|FG001|Participant Flow|Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 12.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
11042485|NCT01263496|FG002|Participant Flow|Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 25 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
10887269|NCT00499603|OG001|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
11042486|NCT01263496|FG003|Participant Flow|Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group|"Alogliptin 50 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 50 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
11042487|NCT01263496|FG004|Participant Flow|Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group|"Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the voglibose 0.2 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
11042488|NCT01263496|FG005|Participant Flow|Placebo Dose Group* → Alogliptin 6.25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
11042489|NCT01263496|FG006|Participant Flow|Placebo Dose Group* → Alogliptin 12.5 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
11042490|NCT01263496|FG007|Participant Flow|Placebo Dose Group* → Alogliptin 25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
11042491|NCT01263496|FG008|Participant Flow|Placebo Dose Group* → Alogliptin 50 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
11042492|NCT01263496|OG000|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
11042493|NCT01263496|OG001|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
11042494|NCT01263496|OG002|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
11042495|NCT01263496|OG003|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
11042496|NCT01263496|OG004|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042497|NCT01263496|EG000|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
11042498|NCT01263496|EG001|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
11042499|NCT01263496|EG002|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
11042500|NCT01263496|EG003|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
11042501|NCT01263496|EG004|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042502|NCT01263509|BG000|Baseline|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042503|NCT01263509|BG001|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042504|NCT01263509|BG002|Baseline|Total|Total of all reporting groups
11042505|NCT01263509|FG000|Participant Flow|12.5 mg Combination Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
11042506|NCT01263509|FG001|Participant Flow|25 mg Combination Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
11042507|NCT01263509|FG002|Participant Flow|α-glucosidase Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
11042508|NCT01263509|FG003|Participant Flow|α-glucosidase Monotherapy Group*→ 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
11042509|NCT01263509|OG000|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042510|NCT01263509|OG001|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042511|NCT01263509|EG000|Reported Event|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042512|NCT01263509|EG001|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
11042513|NCT01263561|BG000|Baseline|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
11042514|NCT01263561|BG001|Baseline|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
11042515|NCT01263561|BG002|Baseline|Total|Total of all reporting groups
11042516|NCT01263561|FG000|Participant Flow|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
11042517|NCT01263561|FG001|Participant Flow|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
11042518|NCT01263561|OG000|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
11042519|NCT01263561|OG001|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
11042520|NCT01263561|EG000|Reported Event|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
11042521|NCT01263561|EG001|Reported Event|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
11042522|NCT01263639|BG000|Baseline|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
11042523|NCT01263639|BG001|Baseline|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
11042524|NCT01263639|BG002|Baseline|Total|Total of all reporting groups
11042525|NCT01263639|FG000|Participant Flow|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
11042526|NCT01263639|FG001|Participant Flow|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
11042527|NCT01263639|OG000|Outcome|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
11042528|NCT01263639|OG001|Outcome|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
11042529|NCT01263639|EG000|Reported Event|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
11042530|NCT01263639|EG001|Reported Event|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
11042531|NCT01263665|BG000|Baseline|Investigational Arm|25 cm length GORE® VIABAHN® Endoprosthesis with> PROPATEN Bioactive Surface Subjects
11042532|NCT01263665|FG000|Participant Flow|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|"25 cm length GORE® VIABAHN® Endoprosthesis with~> PROPATEN Bioactive Surface Subjects"
11042533|NCT01263665|OG000|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with> PROPATEN Bioactive Surface Subjects
11042534|NCT01263665|EG000|Reported Event|25 cm GORE VIABAHN|25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
11042535|NCT01263691|BG000|Baseline|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
11042536|NCT01263691|BG001|Baseline|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042537|NCT01263691|BG002|Baseline|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042538|NCT01263691|BG003|Baseline|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042539|NCT01263691|BG004|Baseline|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042540|NCT01263691|BG005|Baseline|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
11042541|NCT01263691|BG006|Baseline|Total|Total of all reporting groups
11042542|NCT01263691|FG000|Participant Flow|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
11042543|NCT01263691|FG001|Participant Flow|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042544|NCT01263691|FG002|Participant Flow|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042545|NCT01263691|FG003|Participant Flow|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042546|NCT01263691|FG004|Participant Flow|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042547|NCT01263691|FG005|Participant Flow|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
11042548|NCT01263691|OG000|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
11042549|NCT01263691|OG001|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042550|NCT01263691|OG002|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042551|NCT01263691|OG003|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042552|NCT01263691|OG004|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042553|NCT01263691|OG005|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
11042554|NCT01263691|OG000|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042555|NCT01263691|OG001|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042556|NCT01263691|OG002|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042557|NCT01263691|OG003|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042558|NCT01263691|OG004|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042559|NCT01263691|OG005|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042560|NCT01263691|OG006|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042561|NCT01263691|OG007|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042562|NCT01263691|OG008|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042563|NCT01263691|OG009|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042564|NCT01263691|OG010|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042565|NCT01263691|OG011|Outcome|Male Saline|Male Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042566|NCT01263691|OG012|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042567|NCT01263691|OG013|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042568|NCT01263691|OG014|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042569|NCT01263691|OG015|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042570|NCT01263691|OG016|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042571|NCT01263691|OG017|Outcome|Female Saline|Female Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042572|NCT01263691|OG005|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042573|NCT01263691|OG011|Outcome|Male Saline|Male participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042574|NCT01263691|OG017|Outcome|Female Saline|Female participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
11042575|NCT01263691|EG000|Reported Event|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
11042576|NCT01263691|EG001|Reported Event|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042577|NCT01263691|EG002|Reported Event|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042578|NCT01263691|EG003|Reported Event|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042579|NCT01263691|EG004|Reported Event|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
11042580|NCT01263691|EG005|Reported Event|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
11042581|NCT01263704|BG000|Baseline|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
11042582|NCT01263704|FG000|Participant Flow|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
11042583|NCT01263704|OG000|Outcome|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
11042584|NCT01263704|EG000|Reported Event|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
11042585|NCT01263717|BG000|Baseline|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
11042586|NCT01263717|BG001|Baseline|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
11042587|NCT01263717|BG002|Baseline|Total|Total of all reporting groups
11042588|NCT01263717|FG000|Participant Flow|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
11042589|NCT01263717|FG001|Participant Flow|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
11042590|NCT01263717|OG000|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
11042591|NCT01263717|OG001|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
11042592|NCT01263717|EG000|Reported Event|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
11042593|NCT01263717|EG001|Reported Event|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
11042594|NCT01263782|BG000|Baseline|Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe|Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression
11042595|NCT01263782|BG001|Baseline|Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression
11042596|NCT01263782|BG002|Baseline|Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression
11042597|NCT01263782|BG003|Baseline|Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
11042598|NCT01263782|BG004|Baseline|Total|Total of all reporting groups
11042599|NCT01263782|FG000|Participant Flow|Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe|Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression
11042600|NCT01263782|FG001|Participant Flow|Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression
11042601|NCT01263782|FG002|Participant Flow|Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression
11042602|NCT01263782|FG003|Participant Flow|Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
11042603|NCT01263782|OG000|Outcome|Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe|Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression
11042604|NCT01263782|OG001|Outcome|Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression
11042605|NCT01263782|OG002|Outcome|Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression
11042606|NCT01263782|OG003|Outcome|Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
11042607|NCT01263782|EG000|Reported Event|Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe|Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression
11042608|NCT01263782|EG001|Reported Event|Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression
11042609|NCT01263782|EG002|Reported Event|Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression
11042610|NCT01263782|EG003|Reported Event|Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance|Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
11042611|NCT01263873|BG000|Baseline|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
11042612|NCT01263873|BG001|Baseline|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
11042613|NCT01263873|BG002|Baseline|Total|Total of all reporting groups
11042614|NCT01263873|FG000|Participant Flow|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
11042615|NCT01263873|FG001|Participant Flow|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
11042616|NCT01263873|OG000|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
11042617|NCT01263873|OG001|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
11042618|NCT01263873|EG000|Reported Event|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
11042619|NCT01263873|EG001|Reported Event|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
11042620|NCT01263925|BG000|Baseline|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
11042621|NCT01263925|BG001|Baseline|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
11042622|NCT01263925|BG002|Baseline|Total|Total of all reporting groups
11042623|NCT01263925|FG000|Participant Flow|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
11042624|NCT01263925|FG001|Participant Flow|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
11042625|NCT01263925|OG000|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
11042626|NCT01263925|OG001|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
11042627|NCT01263925|EG000|Reported Event|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
11042628|NCT01263925|EG001|Reported Event|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
11042629|NCT01263938|BG000|Baseline|Atorvastatin|"Atorvastatin: For subjects on PI-based HAART therapy: 10mg/day X 2weeks followed by 20mg/day.~For subjects on non PI-based HAART therapy: 20mg/day X 2weeks followed by 40mg/day."
11042630|NCT01263938|FG000|Participant Flow|Atorvastatin|"Atorvastatin: For subjects on PI-based HAART therapy: 10mg/day X 2weeks followed by 20mg/day.~For subjects on non PI-based HAART therapy: 20mg/day X 2weeks followed by 40mg/day."
11042631|NCT01263938|OG000|Outcome|Atorvastatin|"For subjects on PI-based HAART:~10mg/day X 2weeks followed by 20mg/day.~For subjects on non PI-based HAART:~20mg/day X 2weeks followed by 40mg/day.~For all subjects treatment was stopped at 12 weeks."
11042632|NCT01263938|OG000|Outcome|Atorvastatin|"For subjects on PI-based HAART:~10mg/day X 2weeks followed by 20mg/day.~For subjects on non PI-based HAART:~20mg/day X 2weeks followed by 40mg/day."
11042633|NCT01263938|EG000|Reported Event|Atorvastatin|"Atorvastatin: For subjects on PI-based HAART therapy: 10mg/day X 2weeks followed by 20mg/day.~For subjects on non PI-based HAART therapy: 20mg/day X 2weeks followed by 40mg/day."
11042634|NCT01264016|BG000|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable.
11042635|NCT01264016|FG000|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
11042636|NCT01264016|OG000|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
11042637|NCT01264016|OG000|Outcome|Study Staff Test Subject Venous Blood|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood.
11042638|NCT01264016|EG000|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
11042639|NCT01264081|BG000|Baseline|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
11042640|NCT01264081|FG000|Participant Flow|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
11042641|NCT01264081|OG000|Outcome|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
11042642|NCT01264081|EG000|Reported Event|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
11042643|NCT01264380|BG000|Baseline|All Participants|Included all participants who received single oral dose of vemurafenib tablet at 960 mg in fasted condition first and fed condition first in Period A and Period B and twice daily dose of vemurafenib tablet at 960 mg in Period C.
11042644|NCT01264380|FG000|Participant Flow|Vemurafenib (RO5185426): Fasted Then Fed|Single oral dose of vemurafenib tablet at 960 milligrams (mg) on Day 1 was administered to participants in fasted condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fed condition (Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
11042645|NCT01264380|FG001|Participant Flow|Vemurafenib (RO5185426): Fed Then Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fasted condition Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
11042646|NCT01264380|FG002|Participant Flow|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
11042647|NCT01264380|OG000|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
11042648|NCT01264380|OG001|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
11042649|NCT01264380|OG000|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
11042650|NCT01264380|EG000|Reported Event|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
11042651|NCT01264380|EG001|Reported Event|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
11042652|NCT01264380|EG002|Reported Event|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
11348938|NCT04138498|BG003|Baseline|Sequence 4 (DCAB)|"Subjects in sequence DCAB will receive study treatments in the following order: CTx-1301 50 mg tablet, Focalin XR 40 mg capsule, Focalin XR 5 mg capsule, CTx-1301 6.25 mg tablet.~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation"
11042653|NCT01264419|BG000|Baseline|Single|Carotid angioplasty and stenting with Silk Road Embolic Protection System: Major Adverse Event (MAE) rate with reverse flow neuroprotection
11042654|NCT01264419|FG000|Participant Flow|Silk Road Embolic Protection System|Eligible subjects who are to receive a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease
11042655|NCT01264419|OG000|Outcome|Silk Road Embolic Protection System|Eligible subjects who are to receive a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease
11042656|NCT01264419|EG000|Reported Event|Single|Carotid angioplasty and stenting with Silk Road Embolic Protection System: Major Adverse Event (MAE) rate with reverse flow neuroprotection
11042657|NCT01264601|BG000|Baseline|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
11042658|NCT01264601|BG001|Baseline|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
11042659|NCT01264601|BG002|Baseline|Total|Total of all reporting groups
11042660|NCT01264601|FG000|Participant Flow|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
11042661|NCT01264601|FG001|Participant Flow|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
11042662|NCT01264601|OG000|Outcome|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
11042663|NCT01264601|OG001|Outcome|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
11042664|NCT01264601|EG000|Reported Event|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
11042665|NCT01264601|EG001|Reported Event|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
11042666|NCT01264614|BG000|Baseline|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
11042667|NCT01264614|BG001|Baseline|Normative Older Adults|Normative older adults with no known history of neurological condition.
11042668|NCT01264614|BG002|Baseline|Total|Total of all reporting groups
11042669|NCT01264614|FG000|Participant Flow|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
11042670|NCT01264614|FG001|Participant Flow|Normative Older Adults|Normative older adults with no known history of neurological condition.
11042671|NCT01264614|OG000|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
11042672|NCT01264614|OG001|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
11042673|NCT01264614|EG000|Reported Event|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
11042674|NCT01264614|EG001|Reported Event|Normative Older Adults|Normative older adults with no known history of neurological condition.
11042675|NCT01264705|BG000|Baseline|Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily
11042676|NCT01264705|BG001|Baseline|Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily
11042677|NCT01264705|BG002|Baseline|Bavituximab: 3.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
11042678|NCT01264705|BG003|Baseline|Total|Total of all reporting groups
11042679|NCT01264705|FG000|Participant Flow|Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily
11042680|NCT01264705|FG001|Participant Flow|Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily
11042681|NCT01264705|FG002|Participant Flow|Bavituximab: 3.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
11042682|NCT01264705|OG000|Outcome|Cohort 1|Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily
11042683|NCT01264705|OG001|Outcome|Cohort 2|Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily
11042684|NCT01264705|OG002|Outcome|Cohort 3|Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
11042685|NCT01264705|OG000|Outcome|Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|"Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily~bavituximab (0.3 mg/kg) and sorafenib: Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily"
11042686|NCT01264705|OG001|Outcome|Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|"Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily~bavituximab (1.0 mg/kg ) and sorafenib: Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily"
11348939|NCT04138498|BG004|Baseline|Total|Total of all reporting groups
11042687|NCT01264705|OG002|Outcome|Bavituximab: 3.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily|"Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily~bavituximab (3.0 mg/kg) and sorafenib: Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily"
11042688|NCT01264705|EG000|Reported Event|Cohort 1|Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily
11042689|NCT01264705|EG001|Reported Event|Cohort 2|Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily
11042690|NCT01264705|EG002|Reported Event|Cohort 3|Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
11042691|NCT01264718|BG000|Baseline|Intervention: Parent Mentors|Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.
11042692|NCT01264718|BG001|Baseline|Control: No Intervention|Families received traditional Medicaid/CHIP outreach
11042693|NCT01264718|BG002|Baseline|Total|Total of all reporting groups
11042694|NCT01264718|FG000|Participant Flow|Intervention: Parent Mentors|Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.
11042695|NCT01264718|FG001|Participant Flow|Control: No Intervention|Families received traditional Medicaid/CHIP outreach
11042696|NCT01264718|OG000|Outcome|Intervention: Parent Mentors|Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.
11042697|NCT01264718|OG001|Outcome|Control: No Intervention|Families received traditional Medicaid/CHIP outreach
11042698|NCT01264718|EG000|Reported Event|Intervention: Parent Mentors|Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.
11042699|NCT01264718|EG001|Reported Event|Control: No Intervention|Families received traditional Medicaid/CHIP outreach
11042700|NCT01264770|BG000|Baseline|FOSTA 100 MG BID PO|Dosing Group A
10848948|NCT00292942|EG002|Reported Event|4 mg/kg Intravenous Artesunate|"4 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11042701|NCT01264770|BG001|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11042702|NCT01264770|BG002|Baseline|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
11042703|NCT01264770|BG003|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
11042704|NCT01264770|BG004|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
11042705|NCT01264770|BG005|Baseline|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
11042706|NCT01264770|BG006|Baseline|Total|Total of all reporting groups
11042707|NCT01264770|FG000|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
11042708|NCT01264770|FG001|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11042709|NCT01264770|FG002|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
11042710|NCT01264770|FG003|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
11042711|NCT01264770|FG004|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
11042712|NCT01264770|FG005|Participant Flow|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
11042713|NCT01264770|OG000|Outcome|Dosing Group A|FOSTA 100 MG BID PO
11042714|NCT01264770|OG001|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
11042715|NCT01264770|OG002|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
11042716|NCT01264770|OG003|Outcome|Dosing Group E|PLACEBO (COMBINED)
11042717|NCT01264770|OG003|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
11042718|NCT01264770|OG004|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
11042719|NCT01264770|OG005|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
11042720|NCT01264770|OG004|Outcome|Dosing Group E|PLACEBO (COMBINED)
11042721|NCT01264770|OG005|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
11042722|NCT01264770|OG006|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
11042723|NCT01264770|EG000|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
11042724|NCT01264770|EG001|Reported Event|FOSTA 100 MG BID|Dosing Group A
11042725|NCT01264770|EG002|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD|Dosing Group C
11042726|NCT01264770|EG003|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|
11042727|NCT01264770|EG004|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-FOSTAperiod|
11042728|NCT01264770|EG005|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-PBO Period|
11042729|NCT01264770|EG006|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
11042730|NCT01264770|EG007|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
11042731|NCT01264887|BG000|Baseline|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
11042732|NCT01264887|FG000|Participant Flow|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
11042733|NCT01264887|OG000|Outcome|Number of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
11042734|NCT01264887|OG000|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
11042735|NCT01264887|OG000|Outcome|Frequency of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
11042736|NCT01264887|EG000|Reported Event|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
11042737|NCT01264939|BG000|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
11042738|NCT01264939|BG001|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
11042739|NCT01264939|BG002|Baseline|Total|Total of all reporting groups
11042740|NCT01264939|FG000|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
11042741|NCT01264939|FG001|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
11042742|NCT01264939|OG000|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
11042743|NCT01264939|OG001|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
11042744|NCT01264939|EG000|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
11042745|NCT01264939|EG001|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
11042746|NCT01264952|BG000|Baseline|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non-treated metastases on the right side were removed with right hemihepatectomy.
11042747|NCT01264952|BG001|Baseline|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non-treated metastases were removed with liver resection.
11042748|NCT01264952|BG002|Baseline|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
11042749|NCT01264952|BG003|Baseline|Total|Total of all reporting groups
11042750|NCT01264952|FG000|Participant Flow|Bilateral, Multiple, Metachronous Metastases|The first group included patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non-treated metastases on the right side were removed with right hemihepatectomy.
11042751|NCT01264952|FG001|Participant Flow|Synchronous Metastases|The second group (group II) included patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non-treated metastases were removed with liver resection.
11042752|NCT01264952|FG002|Participant Flow|<= 3 Metachronous, Unresectable Liver Metastases|The third group included patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
11042753|NCT01264952|OG000|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non-treated metastases on the right side were removed with right hemihepatectomy.
11042754|NCT01264952|OG001|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non-treated metastases were removed with liver resection.
11042755|NCT01264952|OG002|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
11042756|NCT01264952|EG000|Reported Event|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non-treated metastases on the right side were removed with right hemihepatectomy.
11042757|NCT01264952|EG001|Reported Event|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non-treated metastases were removed with liver resection.
11042758|NCT01264952|EG002|Reported Event|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
11042759|NCT01265056|BG000|Baseline|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
11042760|NCT01265056|BG001|Baseline|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
11042761|NCT01265056|BG002|Baseline|Total|Total of all reporting groups
11042762|NCT01265056|FG000|Participant Flow|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
11042763|NCT01265056|FG001|Participant Flow|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
11042764|NCT01265056|OG000|Outcome|Placebo|Patients received a sugar pill similar to gabapentin.
11042765|NCT01265056|OG001|Outcome|Gabapentin|Patients received gabapentin.
11042766|NCT01265056|EG000|Reported Event|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
11042767|NCT01265056|EG001|Reported Event|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
11042768|NCT01265394|BG000|Baseline|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
11042769|NCT01265394|FG000|Participant Flow|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
11042770|NCT01265394|OG000|Outcome|Normal and Abnormal Reads With or Without Amyloid|Each Subject received a dose of [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
11042771|NCT01265394|OG000|Outcome|(18F) Flutemetamol Injection|Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
11042772|NCT01265394|EG000|Reported Event|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
11042773|NCT01265420|BG000|Baseline|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
11042774|NCT01265420|FG000|Participant Flow|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
11042775|NCT01265420|OG000|Outcome|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
11042776|NCT01265420|EG000|Reported Event|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
11042777|NCT01265446|BG000|Baseline|Lidocaine 8mg +CPC 2mg|one single dose
11042778|NCT01265446|BG001|Baseline|Lidocaine 1mg + CPC 2mg|one single dose
11042779|NCT01265446|BG002|Baseline|Total|Total of all reporting groups
11042780|NCT01265446|FG000|Participant Flow|Lidocaine 8mg +CPC 2mg|one single dose
11042781|NCT01265446|FG001|Participant Flow|Lidocaine 1mg + CPC 2mg|one single dose
11042782|NCT01265446|OG000|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
11042783|NCT01265446|OG001|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
11042784|NCT01265446|EG000|Reported Event|Lidocaine 8mg +CPC 2mg|one single dose
11042785|NCT01265446|EG001|Reported Event|Lidocaine 1mg + CPC 2mg|one single dose
11042786|NCT01265459|BG000|Baseline|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042787|NCT01265459|BG001|Baseline|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042788|NCT01265459|BG002|Baseline|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042789|NCT01265459|BG003|Baseline|Total|Total of all reporting groups
11042790|NCT01265459|FG000|Participant Flow|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042791|NCT01265459|FG001|Participant Flow|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042792|NCT01265459|FG002|Participant Flow|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042793|NCT01265459|OG000|Outcome|Durolane 3 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
11042794|NCT01265459|OG001|Outcome|Durolane 4.5 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
11042795|NCT01265459|OG002|Outcome|Durolane 6 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
11042796|NCT01265459|OG000|Outcome|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042797|NCT01265459|OG001|Outcome|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042798|NCT01265459|OG002|Outcome|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042799|NCT01265459|OG000|Outcome|Durolane 3 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
11042800|NCT01265459|OG001|Outcome|Durolane 4.5 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
11042801|NCT01265459|OG002|Outcome|Durolane 6 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
11042802|NCT01265459|OG000|Outcome|Durolane 3 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
11042803|NCT01265459|OG001|Outcome|Durolane 4.5 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
11042804|NCT01265459|OG002|Outcome|Durolane 6 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
11042805|NCT01265459|OG000|Outcome|Durolane 3 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
11042806|NCT01265459|OG001|Outcome|Durolane 4.5 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
11042807|NCT01265459|OG002|Outcome|Durolane 6 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
11042808|NCT01265459|EG000|Reported Event|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042809|NCT01265459|EG001|Reported Event|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042810|NCT01265459|EG002|Reported Event|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
11042811|NCT01265498|BG000|Baseline|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
11042812|NCT01265498|BG001|Baseline|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
11042813|NCT01265498|BG002|Baseline|Total|Total of all reporting groups
11042814|NCT01265498|FG000|Participant Flow|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
11042815|NCT01265498|FG001|Participant Flow|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
11042816|NCT01265498|OG000|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
11042817|NCT01265498|OG001|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
11042818|NCT01265498|EG000|Reported Event|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
11042819|NCT01265498|EG001|Reported Event|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
11042820|NCT01265511|BG000|Baseline|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
11042821|NCT01265511|BG001|Baseline|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
11042822|NCT01265511|BG002|Baseline|Total|Total of all reporting groups
11042823|NCT01265511|FG000|Participant Flow|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
11042824|NCT01265511|FG001|Participant Flow|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
11042825|NCT01265511|OG000|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
11042826|NCT01265511|OG001|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
11042827|NCT01265511|EG000|Reported Event|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
11042828|NCT01265511|EG001|Reported Event|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
11042829|NCT01265524|BG000|Baseline|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
11042830|NCT01265524|BG001|Baseline|Placebo|Placebo: capsules
11042831|NCT01265524|BG002|Baseline|Total|Total of all reporting groups
11042832|NCT01265524|FG000|Participant Flow|Investigational Drug: CLP|Investigational drug: 15 g CLP per day given as capsules
11042833|NCT01265524|FG001|Participant Flow|Placebo|Placebo: capsules
11042834|NCT01265524|OG000|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
11042835|NCT01265524|OG001|Outcome|Placebo|Placebo: capsules
11042836|NCT01265524|EG000|Reported Event|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
11042837|NCT01265524|EG001|Reported Event|Placebo|Placebo: capsules
11042838|NCT01265537|BG000|Baseline|Low Target Tacrolimus (Advagraf)|"This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and low-target Advagraf.~Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1~Table 1~Months post tx:~0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4"
11226313|NCT02373813|EG001|Reported Event|Double-Blind Treatment: Methotrexate Monotherapy|"Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg)."
11042839|NCT01265537|BG001|Baseline|Standard Target Tacrolimus (Advagraf)|"This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and standard target Advagraf.~Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1~Table 1~Months post tx~0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8."
11042840|NCT01265537|BG002|Baseline|Total|Total of all reporting groups
11042841|NCT01265537|FG000|Participant Flow|Low Target Tacrolimus (Advagraf)|"This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and low-target Advagraf.~Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1~Table 1~Months post tx:~0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4"
11042842|NCT01265537|FG001|Participant Flow|Standard Target Tacrolimus (Advagraf)|"This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and standard target Advagraf.~Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1~Table 1~Months post tx~0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8."
11042843|NCT01265537|OG000|Outcome|Low Target Tacrolimus (Advagraf)|"This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and low-target Advagraf.~Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1~Table 1~Months post tx:~0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4"
11042844|NCT01265537|OG001|Outcome|Standard Target Tacrolimus (Advagraf)|"This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and standard target Advagraf.~Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1~Table 1~Months post tx~0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8."
11042845|NCT01265537|EG000|Reported Event|Low Target Tacrolimus (Advagraf)|"This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and low-target Advagraf.~Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1~Table 1~Months post tx:~0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4"
11042846|NCT01265537|EG001|Reported Event|Standard Target Tacrolimus (Advagraf)|"This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and standard target Advagraf.~Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1~Table 1~Months post tx~0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8."
11042847|NCT01265550|BG000|Baseline|Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042848|NCT01265550|BG001|Baseline|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
11042849|NCT01265550|BG002|Baseline|Placebo Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042850|NCT01265550|BG003|Baseline|Not Randomized|Subset of all enrolled participants who did not end up being randomized to the study.
11042851|NCT01265550|BG004|Baseline|Total|Total of all reporting groups
11042852|NCT01265550|FG000|Participant Flow|Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042853|NCT01265550|FG001|Participant Flow|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
11042854|NCT01265550|FG002|Participant Flow|Placebo Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042855|NCT01265550|FG003|Participant Flow|All Enrolled|All patients consented.
11042856|NCT01265550|OG000|Outcome|Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042857|NCT01265550|OG001|Outcome|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
11042858|NCT01265550|OG002|Outcome|Placebo Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
10848949|NCT00292942|EG003|Reported Event|8 mg/kg Intravenous Artesunate|"8 mg/kg of Intravenous artesunate~Intravenous Artesunate: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)"
11042859|NCT01265550|OG000|Outcome|All Enrolled|All patients consented.
11042860|NCT01265550|OG000|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042861|NCT01265550|OG001|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
11042862|NCT01265550|OG002|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042863|NCT01265550|OG000|Outcome|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
11042864|NCT01265550|EG000|Reported Event|Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042865|NCT01265550|EG001|Reported Event|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
11042866|NCT01265550|EG002|Reported Event|Placebo Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
11042867|NCT01265550|EG003|Reported Event|All Enrolled|All patients consented.
11042868|NCT01265563|BG000|Baseline|NAC Placebo and Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
11042869|NCT01265563|BG001|Baseline|NAC Active and Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
11042870|NCT01265563|BG002|Baseline|NAC Placebo and Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
11042871|NCT01265563|BG003|Baseline|NAC Active and Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
11042872|NCT01265563|BG004|Baseline|NAC Active and High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
11042873|NCT01265563|BG005|Baseline|Total|Total of all reporting groups
10848950|NCT00292981|BG000|Baseline|C1 Esterase Inhibitor|
10848951|NCT00292981|FG000|Participant Flow|C1 Esterase Inhibitor|
10848952|NCT00292981|OG000|Outcome|C1 Esterase Inhibitor|
11042874|NCT01265563|FG000|Participant Flow|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
11042875|NCT01265563|FG001|Participant Flow|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
11066593|NCT01393301|FG000|Participant Flow|Behavioral Intervention Arm|"Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.~Integrated cognitive-behavioral therapy for smoking cessation and anxiety: Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress."
11042876|NCT01265563|FG002|Participant Flow|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
11042877|NCT01265563|FG003|Participant Flow|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
11042878|NCT01265563|FG004|Participant Flow|NAC Active + High Dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
11042879|NCT01265563|OG000|Outcome|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
11042880|NCT01265563|OG001|Outcome|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
11042881|NCT01265563|OG002|Outcome|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
11042882|NCT01265563|OG003|Outcome|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
11042883|NCT01265563|OG004|Outcome|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
11042884|NCT01265563|OG000|Outcome|NAC Placebo and Silibin Placebo|"Drug: N-acetylcysteine placebo and Drug: Silibin placebo~N-acetylcysteine placebo and silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient and silibin placebo orally twice daily for three months"
11042885|NCT01265563|OG001|Outcome|NAC Active and Silibin Placebo|"Drug: N-acetylcysteine and Drug: Silibin placebo~N-acetylcysteine active and silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin placebo orally twice a day for three months"
11042886|NCT01265563|OG002|Outcome|NAC Placebo and Silibin Active|"Drug: N-acetylcysteine placebo and Drug: Silibin active~N-acetylcysteine placebo and silibin active: Dietary Supplement: silibin 480 mg orally twice daily and N-acetylcysteine placebo orally twice a day for three months"
11042887|NCT01265563|OG003|Outcome|NAC Active and Silibin Active|"Drug: N-acetylcysteine active and Drug: Silibin active~N-acetylcysteine active and silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 480 mg orally twice daily for three months"
11042888|NCT01265563|OG004|Outcome|NAC Active and High-dose Silibin Active|"Drug: N-acetylcysteine active and Drug: Silibin higher dose active~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 960 mg orally twice daily for three months"
11066594|NCT01393301|FG001|Participant Flow|Control Arm|"Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).~Control: Enhanced standard smoking cessation treatment and NRT."
11042889|NCT01265563|EG000|Reported Event|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
11042890|NCT01265563|EG001|Reported Event|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
11042891|NCT01265563|EG002|Reported Event|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
11042892|NCT01265563|EG003|Reported Event|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
11042893|NCT01265563|EG004|Reported Event|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
11042894|NCT01265615|BG000|Baseline|Paricalcitol Treatment|6-8 μg daily per os without special diet
11042895|NCT01265615|BG001|Baseline|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
11042896|NCT01265615|BG002|Baseline|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
11042897|NCT01265615|BG003|Baseline|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
11042898|NCT01265615|BG004|Baseline|Total|Total of all reporting groups
11042899|NCT01265615|FG000|Participant Flow|Paricalcitol Treatment|6-8 μg daily per os without special diet
11042900|NCT01265615|FG001|Participant Flow|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
11042901|NCT01265615|FG002|Participant Flow|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
11042902|NCT01265615|FG003|Participant Flow|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
11042903|NCT01265615|OG000|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
11042904|NCT01265615|OG001|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
11042905|NCT01265615|OG002|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
11042906|NCT01265615|OG003|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
11042907|NCT01265615|EG000|Reported Event|Paricalcitol Treatment|6-8 μg daily per os without special diet
11042908|NCT01265615|EG001|Reported Event|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
11042909|NCT01265615|EG002|Reported Event|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
11042910|NCT01265615|EG003|Reported Event|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
11042911|NCT01265667|BG000|Baseline|CF101 2mg|Oral tablets given every 12 hours for 16 weeks
11042912|NCT01265667|BG001|Baseline|Placebo|Oral tablets given every 12 hours for 16 weeks
11042913|NCT01265667|BG002|Baseline|Total|Total of all reporting groups
11042914|NCT01265667|FG000|Participant Flow|CF101 2 mg|CF101: orally q12h
11042915|NCT01265667|FG001|Participant Flow|Placebo|Placebo: orally q12h
11042916|NCT01265667|OG000|Outcome|CF101 2 mg|CF101: orally q12h
11042917|NCT01265667|OG001|Outcome|Placebo|Placebo: orally q12h
11042918|NCT01265667|EG000|Reported Event|CF101 2 mg|CF101: orally q12h
11042919|NCT01265667|EG001|Reported Event|Placebo|Placebo: orally q12h
11042920|NCT01265719|BG000|Baseline|Latanoprost Group|"Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.~Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only."
11042921|NCT01265719|BG001|Baseline|Non Prostaglandin Group|"Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.~Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period."
11042922|NCT01265719|BG002|Baseline|Total|Total of all reporting groups
11226314|NCT02373813|EG002|Reported Event|Double-Blind Treatment: Etanercept Monotherapy|"Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg)."
11226315|NCT02373813|EG003|Reported Event|Double-Blind Treatment: Etanercept Plus Methotrexate|"Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.~After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment)."
11042923|NCT01265719|FG000|Participant Flow|Latanoprost Group|"Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.~Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only."
11042924|NCT01265719|FG001|Participant Flow|Non Prostaglandin Group|"Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.~Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period."
11042925|NCT01265719|OG000|Outcome|Latanoprost Group|"Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.~Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only."
11042926|NCT01265719|OG001|Outcome|Non Prostaglandin Group|"Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.~Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period."
11042927|NCT01265719|EG000|Reported Event|Latanoprost Group|"Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.~Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only."
11042928|NCT01265719|EG001|Reported Event|Non Prostaglandin Group|"Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.~Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period."
11042929|NCT01265797|BG000|Baseline|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
11042930|NCT01265797|BG001|Baseline|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
11042931|NCT01265797|BG002|Baseline|Total|Total of all reporting groups
11226316|NCT02373813|EG004|Reported Event|Open Label Rescue: Etanercept Plus Methotrexate|After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
11042932|NCT01265797|FG000|Participant Flow|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
11042933|NCT01265797|FG001|Participant Flow|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
11042934|NCT01265797|OG000|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
11042935|NCT01265797|OG001|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
11042936|NCT01265797|OG000|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
11042937|NCT01265797|OG001|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
11042938|NCT01265797|EG000|Reported Event|Verum|Verum : wears active cranial electrostimulation (CES) device for 20 minutes daily for 28 days
11042939|NCT01265797|EG001|Reported Event|Sham|Sham: wears sham cranial electrostimulation (CES) device for 20 minutes daily for 28 days
11042940|NCT01265823|BG000|Baseline|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
11042941|NCT01265823|FG000|Participant Flow|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
11042942|NCT01265823|OG000|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
11042943|NCT01265823|OG000|Outcome|Adalimumab in Obese Participants|Obese participants were defined as having a BMI ≥ 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
11042944|NCT01265823|OG001|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as having a BMI < 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
11042945|NCT01265823|OG000|Outcome|Adalimumab in Obese Participants|Obese participants were defined as those with a waist-hip ratio of >1 for men and >0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
11226317|NCT02373852|BG000|Baseline|WIRION|Patients undergoing SVG stenting procedure with the use of the WIRION
11226318|NCT02373852|FG000|Participant Flow|WIRION|Patients undergoing SVG stenting procedure with the use of the WIRION
11226319|NCT02373852|OG000|Outcome|WIRION|Patients undergoing SVG stenting procedure with the use of the WIRION
10848953|NCT00292981|EG000|Reported Event|C1 Esterase Inhibitor|
11042946|NCT01265823|OG001|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as those with a waist-hip ratio of ≤1 for men and ≤0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
11042947|NCT01265823|EG000|Reported Event|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
11042948|NCT01265875|BG000|Baseline|Human Secretin|Human Secretin : Dose Escalation
11042949|NCT01265875|FG000|Participant Flow|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
11042950|NCT01265875|OG000|Outcome|Human Secretin|Human Secretin : Dose Escalation
11042951|NCT01265875|OG000|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
11042952|NCT01265875|EG000|Reported Event|Human Secretin|Human Secretin : Dose Escalation within participant
11042953|NCT01265953|BG000|Baseline|Broccoli Sprout Extract Capsules|Four weeks broccoli sprout extract (BSE) capsules: 200µmol of sulforaphane (SFN) daily, 2 capsules (1 capsule B.I.D.) daily
11042954|NCT01265953|BG001|Baseline|Placebo Capsules|"Four weeks placebo capsules: 2 capsules (1 capsule B.I.D.) daily~Dietary Supplement: Gelatin capsule containing microcrystalline cellulose"
11042955|NCT01265953|BG002|Baseline|Total|Total of all reporting groups
11042956|NCT01265953|FG000|Participant Flow|Supplement|Subjects in this group were administered with broccoli sprout extract.
11042957|NCT01265953|FG001|Participant Flow|Placebo|Subjects in this group were administered with placebo.
11042958|NCT01265953|OG000|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
11042959|NCT01265953|OG001|Outcome|Placebo|Subjects in this group were administered with placebo.
11042960|NCT01265953|EG000|Reported Event|Supplement|Subjects in this group were administered with broccoli sprout extract.
11042961|NCT01265953|EG001|Reported Event|Placebo|Subjects in this group were administered with placebo.
11042962|NCT01265966|BG000|Baseline|Moderate Sedation|Children undergoing moderate sedation for procedures.
11042963|NCT01265966|BG001|Baseline|Deep Sedation|Children undergoing deep sedation for procedures.
11042964|NCT01265966|BG002|Baseline|General Anesthesia|Children undergoing general anesthesia for procedures.
11042965|NCT01265966|BG003|Baseline|Total|Total of all reporting groups
11042966|NCT01265966|FG000|Participant Flow|Moderate Sedation|Children undergoing moderate sedation for procedures.
11042967|NCT01265966|FG001|Participant Flow|Deep Sedation|Children undergoing deep sedation for procedures.
11042968|NCT01265966|FG002|Participant Flow|General Anesthesia|Children undergoing general anesthesia for procedures.
11042969|NCT01265966|OG000|Outcome|Moderate Sedation|Children undergoing moderate sedation for procedures.
11042970|NCT01265966|OG001|Outcome|Deep Sedation|Children undergoing deep sedation for procedures.
11042971|NCT01265966|OG002|Outcome|General Anesthesia|Children undergoing general anesthesia for procedures.
11042972|NCT01265966|EG000|Reported Event|Moderate Sedation|Children undergoing moderate sedation for procedures.
11042973|NCT01265966|EG001|Reported Event|Deep Sedation|Children undergoing deep sedation for procedures.
11042974|NCT01265966|EG002|Reported Event|General Anesthesia|Children undergoing general anesthesia for procedures.
11042975|NCT01265992|BG000|Baseline|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
11042976|NCT01265992|FG000|Participant Flow|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
11042977|NCT01265992|OG000|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
11042978|NCT01265992|EG000|Reported Event|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
11042979|NCT01266018|BG000|Baseline|All Enrolled Subjects|Includes all subjects enrolled in Cohort 1 (n = 9) and Cohort 2 (n = 13).
11042980|NCT01266018|FG000|Participant Flow|Cohort 1: Sensitive Disease|"Cohort 1 comprised subjects with sensitive disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more."
11042981|NCT01266018|FG001|Participant Flow|Cohort 2: Refractory Disease|"Cohort 2 comprised subjects with refractory disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response"
11042982|NCT01266018|OG000|Outcome|Cohort 1: Sensitive Disease|"Includes subjects with sensitive disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more."
11042983|NCT01266018|OG001|Outcome|Cohort 2: Refractory Disease|"Includes subjects with refractory disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response."
11042984|NCT01266018|OG000|Outcome|All Subjects (Pharmacodynamic Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.
11042985|NCT01266018|EG000|Reported Event|All Subjects (Safety Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 13) who received at least 1 dose of study drug.
11226320|NCT02373852|EG000|Reported Event|WIRION|Patients undergoing SVG stenting procedure with the use of the WIRION
11042986|NCT01266070|BG000|Baseline|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
11042987|NCT01266070|FG000|Participant Flow|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
11042988|NCT01266070|OG000|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
11042989|NCT01266070|EG000|Reported Event|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
11042990|NCT01266122|BG000|Baseline|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
11042991|NCT01266122|BG001|Baseline|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
11042992|NCT01266122|BG002|Baseline|Total|Total of all reporting groups
11042993|NCT01266122|FG000|Participant Flow|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
11042994|NCT01266122|FG001|Participant Flow|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
11042995|NCT01266122|OG000|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
11042996|NCT01266122|OG001|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
11042997|NCT01266122|EG000|Reported Event|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
11042998|NCT01266122|EG001|Reported Event|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
11042999|NCT01266148|BG000|Baseline|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
11043000|NCT01266148|BG001|Baseline|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
11043001|NCT01266148|BG002|Baseline|Total|Total of all reporting groups
11043002|NCT01266148|FG000|Participant Flow|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
11043003|NCT01266148|FG001|Participant Flow|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
11043004|NCT01266148|OG000|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
11043005|NCT01266148|OG001|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
11043006|NCT01266148|EG000|Reported Event|Controls|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study
11043007|NCT01266148|EG001|Reported Event|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
11043008|NCT01266161|BG000|Baseline|Placebo|Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
11043009|NCT01266161|BG001|Baseline|Ibuprofen|Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
11043010|NCT01266161|BG002|Baseline|Total|Total of all reporting groups
11043011|NCT01266161|FG000|Participant Flow|Placebo|Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
11043012|NCT01266161|FG001|Participant Flow|Ibuprofen|Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
11043013|NCT01266161|OG000|Outcome|Placebo|Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
11043014|NCT01266161|OG001|Outcome|Ibuprofen|Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
11043015|NCT01266161|EG000|Reported Event|Placebo|Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
11043016|NCT01266161|EG001|Reported Event|Ibuprofen|Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
11043017|NCT01266265|BG000|Baseline|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
11043018|NCT01266265|BG001|Baseline|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
11043019|NCT01266265|BG002|Baseline|Total|Total of all reporting groups
11043020|NCT01266265|FG000|Participant Flow|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
11043021|NCT01266265|FG001|Participant Flow|Control|"The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician"
11043022|NCT01266265|OG000|Outcome|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
11043023|NCT01266265|OG001|Outcome|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
11043024|NCT01266265|EG000|Reported Event|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
11043025|NCT01266265|EG001|Reported Event|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
11043026|NCT01266291|BG000|Baseline|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased by 1 gm/week for one month under the supervision of the study doctor.
11043027|NCT01266291|FG000|Participant Flow|Treatment With Sabril (Vigabatrin)|"The interventional arm of this phase 4 study involved subjects taking vigabatrin (Sabril) in accordance with standard of care, FDA approved dosing instructions. There were no planned arms; all subjects followed the FDA-approved prescribing label.~As there were not multiple treatment arms under investigation, per the FDA-approved prescribing label, the one and only subject who enrolled underwent upward titration happened at a rate of 500mg per week until she reached her maximum tolerated dose, or 3g per day. This dose was decreased as needed under the supervision of the study doctor. Again in accordance with standard of care, FDA-approved prescribing guidelines, when she stopped taking Sabril, her dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor."
11043028|NCT01266291|OG000|Outcome|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
11043029|NCT01266291|EG000|Reported Event|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
11043030|NCT01266317|BG000|Baseline|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
11043031|NCT01266317|FG000|Participant Flow|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
11043032|NCT01266317|OG000|Outcome|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
10848954|NCT00293020|BG000|Baseline|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
11043033|NCT01266317|EG000|Reported Event|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
11066595|NCT01393301|OG000|Outcome|Behavioral Intervention Arm|"Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.~Integrated cognitive-behavioral therapy for smoking cessation and anxiety: Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress."
11066596|NCT01393301|OG001|Outcome|Control Arm|"Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).~Control: Enhanced standard smoking cessation treatment and NRT."
11066597|NCT01393301|EG000|Reported Event|Behavioral Intervention Arm|"Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.~Integrated cognitive-behavioral therapy for smoking cessation and anxiety: Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress."
11066598|NCT01393301|EG001|Reported Event|Control Arm|"Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).~Control: Enhanced standard smoking cessation treatment and NRT."
11066599|NCT01393392|BG000|Baseline|Intensive, Tailored Intervention|"Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.~Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided."
11066600|NCT01393392|BG001|Baseline|Control Intervention|"Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants.~NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit)."
11066601|NCT01393392|BG002|Baseline|Total|Total of all reporting groups
11066602|NCT01393392|FG000|Participant Flow|Intensive, Tailored Intervention|"Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.~Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided."
11066603|NCT01393392|FG001|Participant Flow|Control Intervention|"Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants.~NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit)."
11066604|NCT01393392|OG000|Outcome|Intensive, Tailored Intervention|"Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.~Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided."
11066605|NCT01393392|OG001|Outcome|Control Intervention|"Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants.~NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit)."
10848955|NCT00293020|FG000|Participant Flow|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
10848956|NCT00293020|OG000|Outcome|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
10848957|NCT00293020|EG000|Reported Event|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
11043034|NCT01266447|BG000|Baseline|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
11043035|NCT01266447|FG000|Participant Flow|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
11043036|NCT01266447|OG000|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
11043037|NCT01266447|EG000|Reported Event|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
11043038|NCT01266460|BG000|Baseline|Treatment (ADXS11-001)|"Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11043039|NCT01266460|FG000|Participant Flow|Treatment (ADXS11-001)|"Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11043040|NCT01266460|OG000|Outcome|Treatment (ADXS11-001)|"Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11043041|NCT01266460|EG000|Reported Event|Treatment (ADXS11-001)|"Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11043042|NCT01266590|BG000|Baseline|LY2216684 + Digoxin|Two oral 0.5-milligrams (mg) (two 0.25-mg tablets) doses of digoxin separated by 12 hours on Day 1, followed by once daily 0.25-mg (single 0.25-mg tablet) dose of digoxin on Days 2-14. Daily oral 18-mg (two 9-mg tablets) doses of LY2216684 on Days 8-14.
11043043|NCT01266590|FG000|Participant Flow|LY2216684 + Digoxin|Two oral 0.5-milligrams (mg) (two 0.25-mg tablets) doses of digoxin separated by 12 hours on Day 1, followed by once daily 0.25-mg (single 0.25-mg tablet) dose of digoxin on Days 2-14. Daily oral 18-mg (two 9-mg tablets) doses of LY2216684 on Days 8-14.
11043044|NCT01266590|OG000|Outcome|Digoxin|0.5-milligrams (mg) (two 0.25-mg tablets) digoxin administered orally twice on Day 1 and 0.25-mg (single 0.25-mg tablet) digoxin administered orally once daily on Days 2 through 7.
11043045|NCT01266590|OG001|Outcome|LY2216684 + Digoxin|0.25-mg (single 0.25-mg tablet) digoxin and 18-mg (two 9-mg tablets) LY2216684 administered orally once daily on Days 8 through 14.
11043046|NCT01266590|EG000|Reported Event|Digoxin 0.5mg|0.5-milligrams (mg) (two 0.25-mg tablets) digoxin administered orally twice on Day 1.
11043047|NCT01266590|EG001|Reported Event|Digoxin 0.25mg|0.25-mg (single 0.25-mg tablet) digoxin administered orally once daily on Days 2 through 7.
11043048|NCT01266590|EG002|Reported Event|LY2216684 + Digoxin|0.25-mg (single 0.25-mg tablet) digoxin and 18-mg (two 9-mg tablets) LY2216684 administered orally once daily on Days 8 through 14.
11043049|NCT01266603|BG000|Baseline|High-dose Interleukin-2 (HDIL-2) + recMAGE-A3 Protein (MAGE-A3|In the induction phase, 300 ug of MAGE-A3 +AS15 were given via intramuscular injection every 2 weeks for 6 cycles and then every 3 weeks for 6 cycles. HDIL-2 was initiated on the day following MAGE-A3 CI immunization or up to eight cycles on weeks 1,3,9,11,18.21,27 and 30 at 720,000 IU/kg every 8 h for up to 14 doses each cycle. Following completion of of the 30-week induction HDIL-2 + MAGE-A3, patients who remained on study were continued on the maintenance MAGE-A3 alone alone given every 6 weeks for 4 cycles, then every 12 weeks for 4 cycles, and then every 24 weeks for 4 cycles.
11043050|NCT01266603|FG000|Participant Flow|High-dose Interleukin-2 (HDIL-2) + recMAGE-A3 Protein (MAGE-A3|In the induction phase, 300 ug of MAGE-A3 +AS15 were given via intramuscular injection every 2 weeks for 6 cycles and then every 3 weeks for 6 cycles. HDIL-2 was initiated on the day following MAGE-A3 CI immunization or up to eight cycles on weeks 1,3,9,11,18.21,27 and 30 at 720,000 IU/kg every 8 h for up to 14 doses each cycle. Following completion of of the 30-week induction HDIL-2 + MAGE-A3, patients who remained on study were continued on the maintenance MAGE-A3 alone alone given every 6 weeks for 4 cycles, then every 12 weeks for 4 cycles, and then every 24 weeks for 4 cycles.
11043051|NCT01266603|OG000|Outcome|High-dose Interleukin-2 (HDIL-2) + recMAGE-A3 Protein (MAGE-A3|In the induction phase, 300 ug of MAGE-A3 +AS15 were given via intramuscular injection every 2 weeks for 6 cycles and then every 3 weeks for 6 cycles. HDIL-2 was initiated on the day following MAGE-A3 CI immunization or up to eight cycles on weeks 1,3,9,11,18.21,27 and 30 at 720,000 IU/kg every 8 h for up to 14 doses each cycle. Following completion of of the 30-week induction HDIL-2 + MAGE-A3, patients who remained on study were continued on the maintenance MAGE-A3 alone alone given every 6 weeks for 4 cycles, then every 12 weeks for 4 cycles, and then every 24 weeks for 4 cycles.
10848958|NCT00293033|BG000|Baseline|Onsolis|Includes all subjects and all dose levels
11043052|NCT01266603|EG000|Reported Event|High-dose Interleukin-2 (HDIL-2) + recMAGE-A3 Protein (MAGE-A3|In the induction phase, 300 ug of MAGE-A3 +AS15 were given via intramuscular injection every 2 weeks for 6 cycles and then every 3 weeks for 6 cycles. HDIL-2 was initiated on the day following MAGE-A3 CI immunization or up to eight cycles on weeks 1,3,9,11,18.21,27 and 30 at 720,000 IU/kg every 8 h for up to 14 doses each cycle. Following completion of of the 30-week induction HDIL-2 + MAGE-A3, patients who remained on study were continued on the maintenance MAGE-A3 alone alone given every 6 weeks for 4 cycles, then every 12 weeks for 4 cycles, and then every 24 weeks for 4 cycles.
11043053|NCT01266642|BG000|Baseline|CF-WBI|50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
11043054|NCT01266642|BG001|Baseline|HF-WBI|42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
11043055|NCT01266642|BG002|Baseline|Total|Total of all reporting groups
11043056|NCT01266642|FG000|Participant Flow|CF-WBI|50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
11043057|NCT01266642|FG001|Participant Flow|HF-WBI|42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
11043058|NCT01266642|OG000|Outcome|CF-WBI|50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
11043059|NCT01266642|OG001|Outcome|HF-WBI|42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
11043060|NCT01266642|EG000|Reported Event|CF-WBI|50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
11043061|NCT01266642|EG001|Reported Event|HF-WBI|42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
11043062|NCT01266850|BG000|Baseline|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received 2-mL RotaTeq® orally at 2, 4 and 6 months of age.
11043063|NCT01266850|BG001|Baseline|Group 2: RotaTeq, Rotarix, Rotarix|Participants received 2-mL RotaTeq® orally at 2 months of age, followed by 1-mL Rotarix® orally at 4 and 6 months of age.
11043064|NCT01266850|BG002|Baseline|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received 2-mL RotaTeq® orally at 2 and 4 months of age, followed by 1-mL Rotarix® orally at 6 months of age.
11043065|NCT01266850|BG003|Baseline|Group 4: Rotarix, Rotarix|Participants received 2-mL Rotarix® orally at 2 and 4 months of age.
11043066|NCT01266850|BG004|Baseline|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received 2-mL Rotarix® orally at 2 months of age, followed by 1-mL RotaTeq® orally at 4 and 6 months of age.
11043067|NCT01266850|BG005|Baseline|Total|Total of all reporting groups
11043068|NCT01266850|FG000|Participant Flow|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
11043069|NCT01266850|FG001|Participant Flow|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
11043070|NCT01266850|FG002|Participant Flow|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
11043071|NCT01266850|FG003|Participant Flow|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
11043072|NCT01266850|FG004|Participant Flow|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
11043073|NCT01266850|OG000|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
11043074|NCT01266850|OG001|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
11043075|NCT01266850|OG002|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
11043076|NCT01266850|OG003|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
11043077|NCT01266850|OG004|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
11043078|NCT01266850|EG000|Reported Event|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
11043079|NCT01266850|EG001|Reported Event|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
11043080|NCT01266850|EG002|Reported Event|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
11043081|NCT01266850|EG003|Reported Event|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
11043082|NCT01266850|EG004|Reported Event|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
11043083|NCT01266876|BG000|Baseline|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043084|NCT01266876|BG001|Baseline|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043085|NCT01266876|BG002|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043086|NCT01266876|BG003|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043087|NCT01266876|BG004|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043088|NCT01266876|BG005|Baseline|Total|Total of all reporting groups
11043089|NCT01266876|FG000|Participant Flow|Placebo|Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043090|NCT01266876|FG001|Participant Flow|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043091|NCT01266876|FG002|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043092|NCT01266876|FG003|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043093|NCT01266876|FG004|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043094|NCT01266876|OG000|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043095|NCT01266876|OG001|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043096|NCT01266876|OG002|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043097|NCT01266876|OG003|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043098|NCT01266876|OG004|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043099|NCT01266876|EG000|Reported Event|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043100|NCT01266876|EG001|Reported Event|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043101|NCT01266876|EG002|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043102|NCT01266876|EG003|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043103|NCT01266876|EG004|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
11043104|NCT01266902|BG000|Baseline|Rilpivirine (RPV) (TMC278-C204 [C204])|Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1.
11043105|NCT01266902|BG001|Baseline|RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])|Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.
11043106|NCT01266902|BG002|Baseline|Total|Total of all reporting groups
11043107|NCT01266902|FG000|Participant Flow|Rilpivirine (RPV) (TMC278-C204 [C204])|Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1.
11043108|NCT01266902|FG001|Participant Flow|RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])|Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.
11043109|NCT01266902|FG002|Participant Flow|RPV 25 mg (After Protocol Amendment 3)|All Participants who were continued under a simplified study setting with only a minimum of study-related activities, as per Protocol Amendment 3 continued to receive RPV 25 mg and followed up for safety.
11043110|NCT01266902|OG000|Outcome|Rilpivirine (RPV) (TMC278-C204 [C204])|Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1.
11043111|NCT01266902|OG001|Outcome|RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])|Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.
11043112|NCT01266902|OG000|Outcome|Rilpivirine (RPV) (TMC278-C204 [C204])|Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with a background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1.
11043113|NCT01266902|OG001|Outcome|RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])|Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.
11043114|NCT01266902|EG000|Reported Event|Rilpivirine (RPV) (TMC278-C204 [C204])|Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1.
11043115|NCT01266902|EG001|Reported Event|RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])|Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.
11043116|NCT01266967|BG000|Baseline|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
11043117|NCT01266967|BG001|Baseline|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
11043118|NCT01266967|BG002|Baseline|Total|Total of all reporting groups
11226321|NCT02374060|BG000|Baseline|Periocular Triamcinolone 40mg|"Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0~Second injection permitted at Week 8 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed."
11341327|NCT03681405|BG000|Baseline|Group I (eMMB)|"Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.~Informational Intervention: Given information about mindful movement and breathing~Questionnaire Administration: Ancillary studies"
11043119|NCT01266967|FG000|Participant Flow|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
11043120|NCT01266967|FG001|Participant Flow|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
11043121|NCT01266967|OG000|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
11043122|NCT01266967|OG001|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
11043123|NCT01266967|OG000|Outcome|GSK2118436 150 mg|Participants with or without prior local therapy for brain metastasis received GSK2118436 50 mg and 75 mg capsules either one hour before or 2 hours after a meal twice daily.
11043124|NCT01266967|OG000|Outcome|RGI IUO Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the RGI assay. The RGI assay is a BRAF mutation test developed by Response Genetics Incorporated, and was used to determine eligibility. It employs the allele-specific polymerase chain reaction (ASPCR) methodology, and was offered as an Investigational Use Only assay (only for pre-market investigational purposes).
11043125|NCT01266967|OG001|Outcome|ThxID BRAF Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the ThxID assay. The RGI test was further validated by BioMerieux (BMX THxID assay) for regulatory approval. The THxID IUO assay was used to retrospectively confirm the RGI test results.
11043126|NCT01266967|EG000|Reported Event|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
11043127|NCT01266967|EG001|Reported Event|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
11043128|NCT01266993|BG000|Baseline|Nimenrix Group|Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
11043129|NCT01266993|BG001|Baseline|Menjugate Group|Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
11043130|NCT01266993|BG002|Baseline|Total|Total of all reporting groups
11043131|NCT01266993|FG000|Participant Flow|Nimenrix Group|Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
11043132|NCT01266993|FG001|Participant Flow|Menjugate Group|Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
11043133|NCT01266993|OG000|Outcome|Nimenrix Group|Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
11043134|NCT01266993|OG001|Outcome|Menjugate Group|Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
11043135|NCT01266993|EG000|Reported Event|Nimenrix Group|Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
11043136|NCT01266993|EG001|Reported Event|Menjugate Group|Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
11043137|NCT01267019|BG000|Baseline|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
11043138|NCT01267019|BG001|Baseline|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
11043139|NCT01267019|BG002|Baseline|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
11043140|NCT01267019|BG003|Baseline|Total|Total of all reporting groups
11043141|NCT01267019|FG000|Participant Flow|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
11043142|NCT01267019|FG001|Participant Flow|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
11043143|NCT01267019|FG002|Participant Flow|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
11043144|NCT01267019|OG000|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
11043145|NCT01267019|OG001|Outcome|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
11043146|NCT01267019|OG002|Outcome|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
11043147|NCT01267019|EG000|Reported Event|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
11043148|NCT01267019|EG001|Reported Event|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
11043149|NCT01267019|EG002|Reported Event|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
11043150|NCT01267045|BG000|Baseline|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in Mindfulness-Based Stress Reduction.~Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
11043151|NCT01267045|BG001|Baseline|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
11043152|NCT01267045|BG002|Baseline|Total|Total of all reporting groups
11043153|NCT01267045|FG000|Participant Flow|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction.~Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a class series called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
11043154|NCT01267045|FG001|Participant Flow|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
11149112|NCT01868646|FG000|Participant Flow|Subetta|"Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~One tablet contains: affinity purified antibodies to the C-terminal fragment of the beta subunit receptor insulin - 0.006g*, affinity purified antibodies to endothelial NO synthase - 0.006g*.~*applied onto isomalt crystals as a mixture of three active aqueous-alcoholic dilutions of the drug substance - diluted 100^12, 100^30, 100^200 times, respectively.~Excipients: isomalt, crospovidone, magnesium stearate."
11043155|NCT01267045|OG000|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
11043156|NCT01267045|OG001|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
11043157|NCT01267045|OG000|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
11043158|NCT01267045|EG000|Reported Event|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course.~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
11043159|NCT01267045|EG001|Reported Event|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
11043160|NCT01267136|BG000|Baseline|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
11043161|NCT01267136|BG001|Baseline|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
11043162|NCT01267136|BG002|Baseline|Total|Total of all reporting groups
11043163|NCT01267136|FG000|Participant Flow|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
11043164|NCT01267136|FG001|Participant Flow|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day).
11043165|NCT01267136|OG000|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
11043166|NCT01267136|OG001|Outcome|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
11043167|NCT01267136|OG000|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen: Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
11043168|NCT01267136|OG001|Outcome|Tramadol Suspension|Tramadol suspension: Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
11043169|NCT01267136|EG000|Reported Event|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
11043170|NCT01267136|EG001|Reported Event|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
11043171|NCT01267175|BG000|Baseline|X54 Pump|All subjects transferred from current pump to X54
11043172|NCT01267175|FG000|Participant Flow|X54 Pump|All subjects transferred from current pump to X54
11043173|NCT01267175|OG000|Outcome|X54 Pump|All subjects transferred from current pump to X54
11043174|NCT01267175|EG000|Reported Event|X54 Pump|All subjects transferred from current pump to X54
11043175|NCT01267201|BG000|Baseline|Entire Study Population|Includes all participants randomized to receive methylprednisolone 32 mg tablet first, formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) first and formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) first.
11043176|NCT01267201|FG000|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 1, Formulation 2|Single oral dose of methylprednisolone 32 milligram (mg) tablet on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 milligram/milliliter (mg/mL) at 32 mg (Micronized active pharmaceutical ingredient [API]) on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
11043177|NCT01267201|FG001|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 2, Formulation 1|Single oral dose of methylprednisolone 32 mg tablet on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
11043178|NCT01267201|FG002|Participant Flow|Methylprednisolone Formulation 1, 32 mg Tablet, Formulation 2|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
11043179|NCT01267201|FG003|Participant Flow|Methylprednisolone Formulation 1, Formulation 2, 32 mg Tablet|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
11043180|NCT01267201|FG004|Participant Flow|Methylprednisolone Formulation 2, 32 mg Tablet, Formulation 1|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
11043181|NCT01267201|FG005|Participant Flow|Methylprednisolone Formulation 2, Formulation 1, 32 mg Tablet|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
11043182|NCT01267201|OG000|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
11043183|NCT01267201|OG001|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
11043184|NCT01267201|OG002|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
11043185|NCT01267201|EG000|Reported Event|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
11043186|NCT01267201|EG001|Reported Event|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
11043187|NCT01267201|EG002|Reported Event|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
11043188|NCT01267227|BG000|Baseline|High Dose|Pterostilbene 125 mg twice daily
11043189|NCT01267227|BG001|Baseline|Low Dose|Pterostilbene 50 mg twice daily
11043190|NCT01267227|BG002|Baseline|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
11043191|NCT01267227|BG003|Baseline|Placebo|Matching placebo twice daily
11043192|NCT01267227|BG004|Baseline|Total|Total of all reporting groups
11043193|NCT01267227|FG000|Participant Flow|High Dose|Pterostilbene 125 mg twice daily
11043194|NCT01267227|FG001|Participant Flow|Low Dose|Pterostilbene 50 mg twice daily
11043195|NCT01267227|FG002|Participant Flow|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
11043196|NCT01267227|FG003|Participant Flow|Placebo|Matching placebo twice daily
11043197|NCT01267227|OG000|Outcome|High Dose|Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
11043198|NCT01267227|OG001|Outcome|Low Dose|Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
11043199|NCT01267227|OG002|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
11043200|NCT01267227|OG003|Outcome|Placebo|Matching placebo twice daily. Unadjusted change from baseline.
11043201|NCT01267227|OG000|Outcome|High Dose|Pterostilbene 125 mg twice daily
11043202|NCT01267227|OG001|Outcome|Low Dose|Pterostilbene 50 mg twice daily
11043203|NCT01267227|OG002|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
11043204|NCT01267227|OG003|Outcome|Placebo|Matching placebo twice daily
11043205|NCT01267227|EG000|Reported Event|High Dose|Pterostilbene 125 mg twice daily
11043206|NCT01267227|EG001|Reported Event|Low Dose|Pterostilbene 50 mg twice daily
11043207|NCT01267227|EG002|Reported Event|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
11043208|NCT01267227|EG003|Reported Event|Placebo|Matching placebo twice daily
11043209|NCT01267240|BG000|Baseline|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
11043210|NCT01267240|FG000|Participant Flow|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
11043211|NCT01267240|OG000|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
11226867|NCT02378714|FG001|Participant Flow|BASC + Placebo Varenicline|"Behavioral activation for smoking cessation plus placebo varenicline~BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.~Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11043212|NCT01267240|EG000|Reported Event|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
11043213|NCT01267253|BG000|Baseline|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
11043214|NCT01267253|FG000|Participant Flow|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
11043215|NCT01267253|OG000|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
11043216|NCT01267253|EG000|Reported Event|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
11043217|NCT01267266|BG000|Baseline|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
11043218|NCT01267266|FG000|Participant Flow|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
11043219|NCT01267266|FG001|Participant Flow|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
11043220|NCT01267266|OG000|Outcome|Arm I (Saracatinib)|"Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
11043221|NCT01267266|OG001|Outcome|Arm II (Placebo)|"Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.~hydrocortisone/placebo: Given orally"
11043222|NCT01267266|OG000|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
11043223|NCT01267266|OG001|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
11043224|NCT01267266|EG000|Reported Event|Saracatinib, Lead-in Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
11043225|NCT01267266|EG001|Reported Event|Saracatinib, Randomized Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
11043226|NCT01267266|EG002|Reported Event|Placebo, Randomized Phase|Patients receive placebo once daily on days 1-28.
11043227|NCT01267279|BG000|Baseline|Placebo|Placebo
11043228|NCT01267279|BG001|Baseline|Zoledronic Acid|Zoledronic acid: Zoledronic acid per protocol
11043229|NCT01267279|BG002|Baseline|Total|Total of all reporting groups
11043230|NCT01267279|FG000|Participant Flow|Placebo|Placebo
11043231|NCT01267279|FG001|Participant Flow|Zoledronic Acid|Zoledronic acid: Zoledronic acid per protocol
11043232|NCT01267279|OG000|Outcome|Placebo|Placebo
11043233|NCT01267279|OG001|Outcome|Zoledronic Acid|Zoledronic acid: Zoledronic acid per protocol
11043234|NCT01267279|EG000|Reported Event|Placebo|Placebo
11043235|NCT01267279|EG001|Reported Event|Zoledronic Acid|Zoledronic acid: Zoledronic acid per protocol
11043236|NCT01267292|BG000|Baseline|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
11043237|NCT01267292|BG001|Baseline|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
11043238|NCT01267292|BG002|Baseline|Total|Total of all reporting groups
11043239|NCT01267292|FG000|Participant Flow|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
11043240|NCT01267292|FG001|Participant Flow|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
11043241|NCT01267292|OG000|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
11043242|NCT01267292|OG001|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
11043243|NCT01267292|EG000|Reported Event|Buspirone|"week 1: Buspirone 30 mg BID weeks 2-3: Buspirone 45 mg BID~Buspirone: week 1 = 30 mg BID weeks 2-3 = 45 mg BID"
11043244|NCT01267292|EG001|Reported Event|Placebo|"week 1: Placebo BID weeks 2-3: Placebo BID~Placebo: week 1 = placebo BID weeks 2-3 = placebo BID"
11043245|NCT01267422|BG000|Baseline|All Study Participants|Age,Gender,Ethnicity,Race,Region of Enrollment
11043246|NCT01267422|FG000|Participant Flow|Participants Receiving Treatment in Left Eye|5 participants receiving treatment in left eye
11043247|NCT01267422|FG001|Participant Flow|Participants Receiving Treatment in Right Eye|4 participants receiving treatment in right eye
11043248|NCT01267422|OG000|Outcome|BCVA of Un-treated Eyes|BCVA of un-treated eyes in 9 patients
11043249|NCT01267422|OG001|Outcome|BCVA of Treated Eyes|BCVA of trearted eyes in 9 patients
11043250|NCT01267422|OG000|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ Before Treatment|The mean percentage of CD3+ before treatment;The mean percentage of CD4+ before treatment;The mean percentage of CD8+ before treatment
11043251|NCT01267422|OG001|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ After Treatment|The mean percentage of CD3+ after treatment;The mean percentage of CD4+ after treatment;The mean percentage of CD8+ after treatment
11043252|NCT01267422|OG000|Outcome|IOP Before Treatment|Ophthalmologic examinations includes IOP of 9 paticipants before treatment
11043253|NCT01267422|OG001|Outcome|IOP After Treatment|Ophthalmologic examinations includes IOP of 9 participants after treatment
11043254|NCT01267422|OG000|Outcome|The Mean of Neutralizing Antibody Assay Before Treatment|The mean of Neutralizing antibody assay before treatment of 8 patients
11043255|NCT01267422|OG001|Outcome|The Mean of Neutralizing Antibody Assay After Treatment|The mean of Neutralizing antibody assay after treatment of 8 patients
11043256|NCT01267422|OG000|Outcome|Average RNFL Thickness Before Treatment|Average RNFL thickness before treatment of injected eyes;Average RNFL thickness before treatment of uninjected eyes
11043257|NCT01267422|OG001|Outcome|Average RNFL Thickness After Treatment|Average RNFL thickness after treatment of injected eyes;Average RNFL thickness after treatment of uninjected eyes
11043258|NCT01267422|OG000|Outcome|Mean MD Before Treatment|Mean MD before treatment of injected eyes;Mean MD before treatment of uninjected eyes
11043259|NCT01267422|OG001|Outcome|Mean MD After Treatment|Mean MD after treatment of injected eyes;Mean MD after treatment of uninjected eyes
11043260|NCT01267422|OG000|Outcome|Mean VFI Before Treatment|Mean VFI before treatment of injected eyes;Mean VFI before treatment of uninjected eyes
11043261|NCT01267422|OG001|Outcome|Mean VFI After Treatment|Mean VFI after treatment of injected eyes;Mean VFI after treatment of uninjected eyes
11043262|NCT01267422|EG000|Reported Event|Short-term Affects|Lens may be injured during intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Endophthalmitis after treament. Hyper-susceptibility or immune response during surgery or after surgery.
11043263|NCT01267422|EG001|Reported Event|Long-term Affects|Lens may be injured after intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Blood and urine routine is affected.Liver and kidney function is affected.Immune response after surgery.
11043264|NCT01267656|BG000|Baseline|Overall|The study was a cross-over study, so the 166 treated participants received both treatment groups.
11043265|NCT01267656|FG000|Participant Flow|Lubricating and Rewetting Drops Then AMO Blink Contacts Lubric|"Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.~Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.~AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week."
11043266|NCT01267656|FG001|Participant Flow|AMO Blink Contacts Lubricant Eye Drops Then Lubricating and Re|"AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week~AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.~Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.~Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week."
11043267|NCT01267656|OG000|Outcome|Lubricating and Rewetting Drops|"Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.~Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week."
11043268|NCT01267656|OG001|Outcome|AMO Blink Contacts Lubricant Eye Drops|"AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week~AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week."
11043269|NCT01267656|EG000|Reported Event|Lubricating and Rewetting Drops|"Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.~Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week."
11043270|NCT01267656|EG001|Reported Event|AMO Blink Contacts Lubricant Eye Drops|"AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week~AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week."
11043271|NCT01267864|BG000|Baseline|Metoclopramide|"Metoclopramide 10mg IVSS~Metoclorpamide: 10mg IVSS"
11043272|NCT01267864|BG001|Baseline|Ketorolac|"Ketorolac 30mg IV~Ketorolac: 30g IVSS"
11043273|NCT01267864|BG002|Baseline|Valproate|"1gm IV~Valproate: 1gm IVSS"
11043274|NCT01267864|BG003|Baseline|Total|Total of all reporting groups
11043275|NCT01267864|FG000|Participant Flow|Metoclopramide|"Metoclopramide 10mg IVSS~Metoclorpamide: 10mg IVSS"
11043276|NCT01267864|FG001|Participant Flow|Ketorolac|"Ketorolac 30mg IV~Ketorolac: 30g IVSS"
11043277|NCT01267864|FG002|Participant Flow|Valproate|"1gm IV~Valproate: 1gm IVSS"
11043278|NCT01267864|OG000|Outcome|Metoclopramide|"Metoclopramide 10mg IVSS~Metoclorpamide: 10mg IVSS"
11043279|NCT01267864|OG001|Outcome|Ketorolac|"Ketorolac 30mg IV~Ketorolac: 30g IVSS"
11043280|NCT01267864|OG002|Outcome|Valproate|"1gm IV~Valproate: 1gm IVSS"
11043281|NCT01267864|EG000|Reported Event|Metoclopramide|"Metoclopramide 10mg IVSS~Metoclorpamide: 10mg IVSS"
11043282|NCT01267864|EG001|Reported Event|Ketorolac|"Ketorolac 30mg IV~Ketorolac: 30g IVSS"
11043283|NCT01267864|EG002|Reported Event|Valproate|"1gm IV~Valproate: 1gm IVSS"
11043284|NCT01267929|BG000|Baseline|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
11043285|NCT01267929|BG001|Baseline|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
11043286|NCT01267929|BG002|Baseline|Total|Total of all reporting groups
11043287|NCT01267929|FG000|Participant Flow|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
11043288|NCT01267929|FG001|Participant Flow|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
11043289|NCT01267929|OG000|Outcome|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
11043290|NCT01267929|OG001|Outcome|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
11149113|NCT01868646|FG001|Participant Flow|Placebo|"Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11149114|NCT01868646|OG000|Outcome|Subetta|"Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus"
11043291|NCT01267929|EG000|Reported Event|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
11043292|NCT01267929|EG001|Reported Event|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
11043293|NCT01267994|BG000|Baseline|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
11043294|NCT01267994|FG000|Participant Flow|Open Label Trial|Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease
11043295|NCT01267994|OG000|Outcome|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
11043296|NCT01267994|OG000|Outcome|Single Arm|Subject who received at least one injection of anakinra
11043297|NCT01267994|EG000|Reported Event|Single Arm|Anakinra administered for 84 consecutive days
11043298|NCT01268046|BG000|Baseline|Young Postmenopausal Women - Estrogen|1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
11043299|NCT01268046|BG001|Baseline|Older Postmenopausal Women - Estrogen|1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
11043300|NCT01268046|BG002|Baseline|Younger Postmenopausal Women - Placebo|1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in younger postmenopausal women
11043301|NCT01268046|BG003|Baseline|Older Postmenopausal Women - Placebo|1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in older postmenopausal women
11043302|NCT01268046|BG004|Baseline|Total|Total of all reporting groups
11043303|NCT01268046|FG000|Participant Flow|Young Postmenopausal Women - Estrogen|1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
11043304|NCT01268046|FG001|Participant Flow|Older Postmenopausal Women - Estrogen|1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
11043305|NCT01268046|FG002|Participant Flow|Young Postmenopausal Women - Placebo|1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in younger postmenopausal women
11043306|NCT01268046|FG003|Participant Flow|Older Postmenopausal Women - Placebo|1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in older postmenopausal women
11043307|NCT01268046|OG000|Outcome|Young Postmenopausal Women - Estrogen|1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
11043308|NCT01268046|OG001|Outcome|Older Postmenopausal Women - Estrogen|1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
11043309|NCT01268046|OG002|Outcome|Young Postmenopausal Women - Placebo|1 placebo capsule administered daily for one month OR 1 transdermal placebo patch with patch change every 84 hr for one month in younger postmenopausal women
11043310|NCT01268046|OG003|Outcome|Older Postmenopausal Women - Placebo|1 placebo capsule administered daily for one month OR 1 transdermal placebo patch with patch change every 84 hr for one month in younger postmenopausal women
11043311|NCT01268046|EG000|Reported Event|Young Postmenopausal Women - Estrogen|1 oral capsule (1 mg estradiol) administered daily for one month OR : 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
11043312|NCT01268046|EG001|Reported Event|Older Postmenopausal Women - Estrogen|1 oral capsule (1 mg estradiol) administered daily for one month OR : 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
11043313|NCT01268046|EG002|Reported Event|Young Postmenopausal Women - Placebo|1 placebo capsule administered daily for one month OR 1 transdermal placebo patch with patch change every 84 hr for one month in younger postmenopausal women
11043314|NCT01268046|EG003|Reported Event|Older Postmenopausal Women - Placebo|1 placebo capsule administered daily for one month OR 1 transdermal placebo patch with patch change every 84 hr for one month in younger postmenopausal women
11043315|NCT01268059|BG000|Baseline|Carboplatin/Paclitaxel (C/P): North America/EU Population|Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve [AUC] of 6 milligram per milliliter into minute [mg/mL*min], and paclitaxel 200 milligram per square meter [mg/m^2]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043316|NCT01268059|BG001|Baseline|C/P + MEDI-575 (C/P/M): North America/EU Population|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043317|NCT01268059|BG002|Baseline|Carboplatin/Paclitaxel (C/P): Japan Population|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) administered as an IV infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043318|NCT01268059|BG003|Baseline|C/P + MEDI-575 (C/P/M): Japan Population|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043319|NCT01268059|BG004|Baseline|Total|Total of all reporting groups
11043320|NCT01268059|FG000|Participant Flow|Carboplatin/Paclitaxel (C/P): North America/EU Population|Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve [AUC] of 6 milligram per milliliter into minute [mg/mL*min], and paclitaxel 200 milligram per square meter [mg/m^2]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043321|NCT01268059|FG001|Participant Flow|C/P + MEDI-575 (C/P/M): North America/EU Population|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043322|NCT01268059|FG002|Participant Flow|Carboplatin/Paclitaxel (C/P): Japan Population|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) administered as an IV infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043323|NCT01268059|FG003|Participant Flow|C/P + MEDI-575 (C/P/M): Japan Population|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043324|NCT01268059|OG000|Outcome|Carboplatin/Paclitaxel + MEDI-575 - Phase 1b|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043325|NCT01268059|OG000|Outcome|Carboplatin/Paclitaxel - North America/European Union (EU)|Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve [AUC] of 6 milligram per milliliter into minute [mg/mL*min], and paclitaxel 200 milligram per square meter [mg/m^2]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043326|NCT01268059|OG001|Outcome|Carboplatin/Paclitaxel + MEDI-575 - North America/EU|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043327|NCT01268059|OG002|Outcome|Carboplatin/Paclitaxel - Japan|Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve [AUC] of 6 milligram per milliliter into minute [mg/mL*min], and paclitaxel 200 milligram per square meter [mg/m^2]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043328|NCT01268059|OG003|Outcome|Carboplatin/Paclitaxel + MEDI-575 - Japan|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043329|NCT01268059|OG000|Outcome|Carboplatin/Paclitaxel (Total)|Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve [AUC] of 6 milligram per milliliter into minute [mg/mL*min], and paclitaxel 200 milligram per square meter [mg/m^2]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043330|NCT01268059|OG001|Outcome|Carboplatin/Paclitaxel + MEDI-575 (Total)|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043331|NCT01268059|OG001|Outcome|Carboplatin/Paclitaxel + MEDI-575 - Phase 2|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043332|NCT01268059|OG002|Outcome|Carboplatin/Paclitaxel - Phase 2|Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve [AUC] of 6 milligram per milliliter into minute [mg/mL*min], and paclitaxel 200 milligram per square meter [mg/m^2]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043333|NCT01268059|EG000|Reported Event|Carboplatin/Paclitaxel + MEDI-575 (Total)|Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL*min, and paclitaxel 200 mg/m^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
11043334|NCT01268059|EG001|Reported Event|Carboplatin/Paclitaxel (Total)|Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve [AUC] of 6 milligram per milliliter into minute [mg/mL*min], and paclitaxel 200 milligram per square meter [mg/m^2]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
11043335|NCT01268098|BG000|Baseline|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
11043336|NCT01268098|BG001|Baseline|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
11043337|NCT01268098|BG002|Baseline|Total|Total of all reporting groups
11043338|NCT01268098|FG000|Participant Flow|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily.
11341328|NCT03681405|BG001|Baseline|Group II (AC)|"Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.~Questionnaire Administration: Ancillary studies~Telephone-Based Intervention: Receive caring attention phone call"
11043339|NCT01268098|FG001|Participant Flow|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily.
11043340|NCT01268098|OG000|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
11043341|NCT01268098|OG001|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
11043342|NCT01268098|EG000|Reported Event|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
11043343|NCT01268098|EG001|Reported Event|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
11043344|NCT01268111|BG000|Baseline|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
11043345|NCT01268111|BG001|Baseline|Placebo|Matching placebo q weekly for 8 weeks
11043346|NCT01268111|BG002|Baseline|Total|Total of all reporting groups
11043347|NCT01268111|FG000|Participant Flow|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
11043348|NCT01268111|FG001|Participant Flow|Placebo|Matching placebo q weekly for 8 weeks
11043349|NCT01268111|OG000|Outcome|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
11043350|NCT01268111|OG001|Outcome|Placebo|Matching placebo q weekly for 8 weeks
11043351|NCT01268111|EG000|Reported Event|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
11043352|NCT01268111|EG001|Reported Event|Placebo|Matching placebo q weekly for 8 weeks
11043353|NCT01268150|BG000|Baseline|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
11043354|NCT01268150|FG000|Participant Flow|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
11043355|NCT01268150|OG000|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
11043356|NCT01268150|EG000|Reported Event|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
11043357|NCT01268189|BG000|Baseline|Burn Wound Patients|Burn wound patients with oxygen diffusing dressing placed on 1 donor skin graft site and standard of care (Xeroform) dressing placed on a 2nd donor skin graft
11043358|NCT01268189|FG000|Participant Flow|Burn Wound Patients|Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites
11043359|NCT01268189|OG000|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
11043360|NCT01268189|OG001|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
11043361|NCT01268189|EG000|Reported Event|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
11043362|NCT01268189|EG001|Reported Event|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
11043363|NCT01268267|BG000|Baseline|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
11341329|NCT03681405|BG002|Baseline|Total|Total of all reporting groups
11043364|NCT01268267|FG000|Participant Flow|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
11043365|NCT01268267|OG000|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
11043366|NCT01268267|OG000|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
11043367|NCT01268267|EG000|Reported Event|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
11043368|NCT01268293|BG000|Baseline|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
11043369|NCT01268293|FG000|Participant Flow|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
11043370|NCT01268293|OG000|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
11043371|NCT01268293|EG000|Reported Event|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
11043372|NCT01268306|BG000|Baseline|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
11043373|NCT01268306|FG000|Participant Flow|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
11043374|NCT01268306|OG000|Outcome|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
11043375|NCT01268306|EG000|Reported Event|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
11043376|NCT01268488|BG000|Baseline|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
11043377|NCT01268488|FG000|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
11043378|NCT01268488|OG000|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
11043379|NCT01268488|OG000|Outcome|Intended Users of the System|Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
11043380|NCT01268488|EG000|Reported Event|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
11043381|NCT01268501|BG000|Baseline|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
11043382|NCT01268501|FG000|Participant Flow|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
11043383|NCT01268501|OG000|Outcome|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
11043384|NCT01268501|EG000|Reported Event|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
11043385|NCT01268514|BG000|Baseline|Permacol Biological Implant Single Arm|"Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study.~At the Screening/Baseline (-60 days) the following patient elements are collected:~Informed Consent~Demographic Information~Medical History~Surgical History~Concomitant Medications~Physical Exam~Radiographic Exam"
11043386|NCT01268514|FG000|Participant Flow|Permacol Biological Implant Single Arm|Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study.
11043387|NCT01268514|OG000|Outcome|Permacol Implant|This is the number of patients who returned for their 36 month follow-up and who were assessed for hernia recurrence.
11043388|NCT01268514|OG000|Outcome|Permacol Biological Implant Single Arm|Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study.
11043389|NCT01268514|OG000|Outcome|Permacol Implant|Permacol biological mesh implant
11043390|NCT01268514|EG000|Reported Event|Permacol Biological Implant Single Arm|Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study.
11043391|NCT01268527|BG000|Baseline|Cohort 1|Three concentrations of E6201 topical gel (0.03%, 0.1%, and 0.2%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site using separate tuberculin syringes that were filled with approximately 200 uL of each concentration of study treatment and comparator. Prior to each new application, remaining preparation residues were removed by gently cleansing each test field with a separate soft tissue. The fields to be treated were done in an occlusive manner for a treatment period of 12 days. Application time was to be kept as close as possible to the baseline application time, and was not to differ by more than +/- 4 hours. The 3 concentrations of E6201 gel were dosed first in Cohort 1 to establish the safety and tolerability prior to dosing in Cohort 2.
11043392|NCT01268527|BG001|Baseline|Cohort 2|Three concentrations of E6201 topical gel (0.005%, 0.01%, and 0.05%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described for Cohort 1. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated.
11043393|NCT01268527|BG002|Baseline|Total|Total of all reporting groups
11043394|NCT01268527|FG000|Participant Flow|Cohort 1|Three concentrations of E6201 topical gel (0.03%, 0.1%, and 0.2%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site using separate tuberculin syringes that were filled with approximately 200 uL of each concentration of study treatment and comparator. Prior to each new application, remaining preparation residues were removed by gently cleansing each test field with a separate soft tissue. The fields to be treated were done in an occlusive manner for a treatment period of 12 days. Application time was to be kept as close as possible to the baseline application time, and was not to differ by more than +/- 4 hours. The 3 concentrations of E6201 gel were dosed first in Cohort 1 to establish the safety and tolerability prior to dosing in Cohort 2.
11043395|NCT01268527|FG001|Participant Flow|Cohort 2|Three concentrations of E6201 topical gel (0.005%, 0.01%, and 0.05%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described for Cohort 1. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated.
11043396|NCT01268527|OG000|Outcome|Daivonex (Calcipotriene Cream)|Daivonex (calcipotriene cream) at 0.005% was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site using a tuberculin syringe that was filled with approximately 200 uL of Daivonex. Prior to each new application, remaining preparation residues were removed by gently cleansing each test field with a separate soft tissue. The fields to be treated were done in an occlusive manner for a treatment period of 12 days. Application time was to be kept as close as possible to the baseline application time, and was not to differ by more than +/- 4 hours.
11043397|NCT01268527|OG001|Outcome|E6201 Vehicle|E6201 vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043398|NCT01268527|OG002|Outcome|0.005% E6201 Gel|E6201 gel (0.005%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043399|NCT01268527|OG003|Outcome|0.01% E6201 Gel|E6201 gel (0.01%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043400|NCT01268527|OG004|Outcome|0.03% E6201 Gel|E6201 gel (0.03%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043401|NCT01268527|OG005|Outcome|0.05% E6201 Gel|E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043402|NCT01268527|OG006|Outcome|0.1% E6201 Gel|E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043403|NCT01268527|OG007|Outcome|0.2% E6201 Gel|E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043404|NCT01268527|OG001|Outcome|E6201 Vehicle|E6201-vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11149115|NCT01868646|OG001|Outcome|Placebo|"Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11348940|NCT04138498|FG000|Participant Flow|Sequence 1 (ADBC)|"Subjects in sequence ADBC received study treatments in the following order: Focalin XR 5 mg capsule, CTx-1301 50 mg tablet, CTx-1301 6.25 mg tablet, Focalin XR 40 mg capsule.~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation"
11043405|NCT01268527|EG000|Reported Event|Daivonex (Calcipotriene Cream)|Daivonex (calcipotriene cream) at 0.005% was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site using a tuberculin syringe that was filled with approximately 200 uL of Daivonex. Prior to each new application, remaining preparation residues were removed by gently cleansing each test field with a separate soft tissue. The fields to be treated were done in an occlusive manner for a treatment period of 12 days. Application time was to be kept as close as possible to the baseline application time, and was not to differ by more than +/- 4 hours.
11043406|NCT01268527|EG001|Reported Event|E6201 Vehicle|E6201 vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043407|NCT01268527|EG002|Reported Event|0.005% E6201 Gel|E6201 gel (0.005%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043408|NCT01268527|EG003|Reported Event|0.01% E6201 Gel|E6201 gel (0.01%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043409|NCT01268527|EG004|Reported Event|0.03% E6201 Gel|E6201 gel (0.03%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043410|NCT01268527|EG005|Reported Event|0.05% E6201 Gel|E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043411|NCT01268527|EG006|Reported Event|0.1% E6201 Gel|E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043412|NCT01268527|EG007|Reported Event|0.2% E6201 Gel|E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier.
11043413|NCT01268553|BG000|Baseline|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
11043414|NCT01268553|FG000|Participant Flow|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
11043415|NCT01268553|OG000|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
11043416|NCT01268553|EG000|Reported Event|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
11043417|NCT01268566|BG000|Baseline|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
11043418|NCT01268566|FG000|Participant Flow|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
11043419|NCT01268566|OG000|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
11043420|NCT01268566|EG000|Reported Event|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
11043421|NCT01268644|BG000|Baseline|Week 0 (Baseline)|After a 4-week lead-in period, baseline evaluation was conducted at week 0.
11043422|NCT01268644|FG000|Participant Flow|Leptin Therapy in T1DM Patients|After a 4-week lead-in period, baseline evaluation was conducted at week 0.
11043423|NCT01268644|OG000|Outcome|Leptin Therapy Week 12|Change in HbA1c after 12 weeks on Leptin Therapy from Baseline.
11043424|NCT01268644|OG000|Outcome|Leptin Therapy in TIDM Patients|Change in Body Weight after 12 weeks on Leptin Therapy compared to Baseline value
11043425|NCT01268644|OG000|Outcome|Leptin Therapy in TIDM Patients|Change in Daily insulin dose after 12 weeks on Leptin Therapy compared to insulin dose during the Baseline period
11043426|NCT01268644|OG000|Outcome|Week 20 (On Leptin)|Change in Hba1c after 20 weeks on Leptin Therapy compared to Baseline value. With ongoing metreleptin therapy, the concomitant basal insulin dose was actively reduced by 50% after week 12.
11043427|NCT01268644|EG000|Reported Event|Overall Study|After a 4-week lead-in period, baseline evaluation was conducted at week 0.
11043428|NCT01268683|BG000|Baseline|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
11043429|NCT01268683|FG000|Participant Flow|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
11043430|NCT01268683|OG000|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
11043431|NCT01268683|EG000|Reported Event|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
11043432|NCT01268891|BG000|Baseline|Placebo|Once daily; tablet; orally; 18 weeks
11043433|NCT01268891|BG001|Baseline|Azilect®|1 mg daily; tablet; orally; 18 weeks
11043434|NCT01268891|BG002|Baseline|Total|Total of all reporting groups
11043435|NCT01268891|FG000|Participant Flow|Placebo|Once daily; tablet; orally; 18 weeks
11043436|NCT01268891|FG001|Participant Flow|Azilect®|1 mg daily; tablet; orally; 18 weeks
11043437|NCT01268891|OG000|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
11043438|NCT01268891|OG001|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
11043439|NCT01268891|EG000|Reported Event|Placebo|
11043440|NCT01268891|EG001|Reported Event|Azilect®|
11043441|NCT01268943|BG000|Baseline|1000mg|capecitabine 500mg/m2 twice daily. 6 patients enrolled
11043442|NCT01268943|BG001|Baseline|1200mg|capecitabine 600mg/m2 twice daily. 3 patients enrolled
11043443|NCT01268943|BG002|Baseline|1400mg|capecitabine 700mg/m2 twice daily. 3 patients enrolled
11043444|NCT01268943|BG003|Baseline|1500mg|capecitabine 750mg/m2 twice daily. 6 patients enrolled
11043445|NCT01268943|BG004|Baseline|Total|Total of all reporting groups
11043446|NCT01268943|FG000|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043447|NCT01268943|FG001|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043448|NCT01268943|FG002|Participant Flow|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043449|NCT01268943|FG003|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043450|NCT01268943|OG000|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043451|NCT01268943|OG001|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
10887308|NCT00499681|FG001|Participant Flow|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
11043452|NCT01268943|OG002|Outcome|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043453|NCT01268943|OG003|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043454|NCT01268943|EG000|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043455|NCT01268943|EG001|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043456|NCT01268943|EG002|Reported Event|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043457|NCT01268943|EG003|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
11043458|NCT01269047|BG000|Baseline|Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
11043459|NCT01269047|BG001|Baseline|Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
11043460|NCT01269047|BG002|Baseline|Insulin Monotherapy|"This group will be on their regular insulin therapy.~Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study."
11043461|NCT01269047|BG003|Baseline|Total|Total of all reporting groups
11043462|NCT01269047|FG000|Participant Flow|Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
11043463|NCT01269047|FG001|Participant Flow|Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
11043464|NCT01269047|FG002|Participant Flow|Insulin Monotherapy|"This group will be on their regular insulin therapy.~Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study."
11043465|NCT01269047|OG000|Outcome|Acute Pramlintide + Insulin Group|"The kids in Exenatide group will get a single dose of Pramlintide at the end of 4 months as part of the 4 hour MMTT.~The dose of pramlintide used for acute treatment is either 30 mcg or 60 mcg"
11043466|NCT01269047|OG001|Outcome|Acute Exenatide + Insulin Group|"The kids in Pramlintide group will get a single dose of Exenatide at the end of 4 months as part of the 4 hour MMTT.~The dose of pramlintide used for acute treatment is either 1.25 mcg or 2.5 mcg"
11043467|NCT01269047|OG002|Outcome|Chronic Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
11043468|NCT01269047|OG003|Outcome|Chronic Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
11043469|NCT01269047|OG004|Outcome|Insulin Monotherapy|These kids received insulin only treatment
11043470|NCT01269047|EG000|Reported Event|Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
11043471|NCT01269047|EG001|Reported Event|Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
11043472|NCT01269047|EG002|Reported Event|Insulin Monotherapy|"This group will be on their regular insulin therapy.~Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study."
11043473|NCT01269125|BG000|Baseline|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
11043474|NCT01269125|BG001|Baseline|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
11043475|NCT01269125|BG002|Baseline|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
11043476|NCT01269125|BG003|Baseline|Total|Total of all reporting groups
11043477|NCT01269125|FG000|Participant Flow|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
11043478|NCT01269125|FG001|Participant Flow|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
11043479|NCT01269125|FG002|Participant Flow|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
11043480|NCT01269125|OG000|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
11043481|NCT01269125|OG001|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
11043482|NCT01269125|OG002|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
11043483|NCT01269125|EG000|Reported Event|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
11043484|NCT01269125|EG001|Reported Event|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
11043485|NCT01269125|EG002|Reported Event|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
11043486|NCT01269346|BG000|Baseline|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
11043487|NCT01269346|FG000|Participant Flow|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as an IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
11043488|NCT01269346|OG000|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
11043489|NCT01269346|OG000|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
11043490|NCT01269346|EG000|Reported Event|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
11043491|NCT01269372|BG000|Baseline|Reporting Group|"This was a single center study where 30 patients were enrolled. No formal sample sizing has been performed as this study was a pilot for a larger multicenter trial.~All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps."
11043492|NCT01269372|FG000|Participant Flow|Reporting Group|"This was a single center study where 30 patients were enrolled. No formal sample sizing has been performed as this study was a pilot for a larger multicenter trial.~All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps."
11043493|NCT01269372|OG000|Outcome|PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp|All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp >= 6mm
11043494|NCT01269372|OG001|Outcome|PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp|All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp >= 10mm
11043495|NCT01269372|OG000|Outcome|PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp|All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of polyps >= 6mm per segment
11043496|NCT01269372|OG001|Outcome|PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp|All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection for polyp >= 10mm per segment
11043497|NCT01269372|OG000|Outcome|PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp|All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Specificity is presented for the detection of polyps >= 6mm per segment
11043498|NCT01269372|OG001|Outcome|PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp|All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Specificity is presented for the detection for polyp >= 10mm per segment
11043499|NCT01269372|EG000|Reported Event|PillCam Colon 2 and Standard Colonoscopy|All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy.
11043500|NCT01269385|BG000|Baseline|All Patients|"During one 35-day period of treatment:~Patients receive 1, 2, or 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously~3 mg day 3~10 mg day 4~30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11149116|NCT01868646|EG000|Reported Event|Subetta|"Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus"
11149117|NCT01868646|EG001|Reported Event|Placebo|"Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).~Placebo"
11149118|NCT01868776|BG000|Baseline|Buffered|buffered lidocaine
11149119|NCT01868776|BG001|Baseline|Nonbuffered|nonbuffered lidocaine
11149120|NCT01868776|BG002|Baseline|Total|Total of all reporting groups
11149121|NCT01868776|FG000|Participant Flow|Buffered|buffered lidocaine
11149122|NCT01868776|FG001|Participant Flow|Nonbuffered|nonbuffered lidocaine
11149123|NCT01868776|OG000|Outcome|Buffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.~buffered lidocaine"
11149124|NCT01868776|OG001|Outcome|Nonbuffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine~nonbuffered lidocaine"
11149125|NCT01868776|EG000|Reported Event|Buffered|buffered lidocaine
11149126|NCT01868776|EG001|Reported Event|Nonbuffered|nonbuffered lidocaine
11149127|NCT01868789|BG000|Baseline|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
11149128|NCT01868789|BG001|Baseline|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
11149129|NCT01868789|BG002|Baseline|Total|Total of all reporting groups
11149130|NCT01868789|FG000|Participant Flow|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
11149131|NCT01868789|FG001|Participant Flow|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
11149132|NCT01868789|OG000|Outcome|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
11149133|NCT01868789|OG001|Outcome|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
11149134|NCT01868789|EG000|Reported Event|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
11149135|NCT01868789|EG001|Reported Event|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
11149136|NCT01868893|BG000|Baseline|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
11149137|NCT01868893|FG000|Participant Flow|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
11149138|NCT01868893|OG000|Outcome|Obinutuzumab|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6.
11149139|NCT01868893|OG001|Outcome|Chlorambucil|Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6.
11149140|NCT01868893|OG000|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
11149141|NCT01868893|EG000|Reported Event|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
11149142|NCT01868997|BG000|Baseline|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
11149143|NCT01868997|BG001|Baseline|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
11149144|NCT01868997|BG002|Baseline|Total|Total of all reporting groups
11149145|NCT01868997|FG000|Participant Flow|Placebo|A placebo infusion (normal saline) was administered once every 3 weeks (q3W) by intravenous (IV) infusion over a period of 24 weeks for a total of 8 infusions.
11149146|NCT01868997|FG001|Participant Flow|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
11149147|NCT01868997|OG000|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
11043501|NCT01269385|FG000|Participant Flow|Phase I: Dose Level 0|"During one 35-day period of treatment:~Patients receive 1 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043502|NCT01269385|FG001|Participant Flow|Phase I: Dose Level 1|"During one 35-day period of treatment:~Patients receive 2 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043503|NCT01269385|FG002|Participant Flow|Phase I: Dose Level 2|"During one 35-day period of treatment:~Patients receive 4 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043504|NCT01269385|FG003|Participant Flow|Phase II: Dose Level 2|"During one 35-day period of treatment:~Patients receive 4 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043505|NCT01269385|OG000|Outcome|Phase I: Dose Level 0|"During one 35-day period of treatment:~Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043506|NCT01269385|OG001|Outcome|Phase I: Dose Level 1|"During one 35-day period of treatment:~Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043507|NCT01269385|OG002|Outcome|Phase I: Dose Level 2|"During one 35-day period of treatment:~Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043508|NCT01269385|OG000|Outcome|Dose Level 2|"During one 35-day period of treatment:~Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043509|NCT01269385|OG000|Outcome|All Patients|"During one 35-day period of treatment:~Patients receive 1, 2, or 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.~Treatment continues in the absence of disease progression or unacceptable toxicity."
11043510|NCT01269385|EG000|Reported Event|Dose Level 0|"During one 35-day period of treatment:~Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity."
11043511|NCT01269385|EG001|Reported Event|Dose Level 1|"During one 35-day period of treatment:~Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity."
11043512|NCT01269385|EG002|Reported Event|Dose Level 2|"During one 35-day period of treatment:~Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31~Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.~Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity."
11043513|NCT01269710|BG000|Baseline|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
11043514|NCT01269710|FG000|Participant Flow|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
11149148|NCT01868997|OG001|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
11043515|NCT01269710|OG000|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
11043516|NCT01269710|EG000|Reported Event|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
11043517|NCT01269736|BG000|Baseline|Nurses|Nurses on participating units who received education at the time hospital assigned to the standard training or online ECG education training.
11043518|NCT01269736|BG001|Baseline|Patients|Patients on participating units on whom quality of care data was obtained.
11043519|NCT01269736|BG002|Baseline|Total|Total of all reporting groups
11043520|NCT01269736|FG000|Participant Flow|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
11043521|NCT01269736|FG001|Participant Flow|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
11043522|NCT01269736|OG000|Outcome|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
11043523|NCT01269736|OG001|Outcome|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
11043524|NCT01269736|EG000|Reported Event|Online ECG Education- Patient Outcomes|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Outcomes groups.
11043525|NCT01269736|EG001|Reported Event|Standard Care Then Online ECG Monitoring- Patient Outcomes|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Outcomes groups.
11043526|NCT01269736|EG002|Reported Event|Online ECG Education- Quality of Care|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Quality of Care groups.
11043527|NCT01269736|EG003|Reported Event|Standard Care Then Online ECG Monitoring- Quality of Care|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. Patient Quality of Care groups.
11043528|NCT01269801|BG000|Baseline|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
11043529|NCT01269801|BG001|Baseline|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
11043530|NCT01269801|BG002|Baseline|Total|Total of all reporting groups
11043531|NCT01269801|FG000|Participant Flow|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
11043532|NCT01269801|FG001|Participant Flow|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
11043533|NCT01269801|OG000|Outcome|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
11043534|NCT01269801|OG001|Outcome|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
11043535|NCT01269801|EG000|Reported Event|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
11043536|NCT01269801|EG001|Reported Event|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
11043537|NCT01269918|BG000|Baseline|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
11043538|NCT01269918|BG001|Baseline|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
11043539|NCT01269918|BG002|Baseline|Total|Total of all reporting groups
11043540|NCT01269918|FG000|Participant Flow|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
11043541|NCT01269918|FG001|Participant Flow|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
11043542|NCT01269918|OG000|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
11043543|NCT01269918|OG001|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
11043544|NCT01269918|EG000|Reported Event|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
11043545|NCT01269918|EG001|Reported Event|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
11043546|NCT01270126|BG000|Baseline|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
11043547|NCT01270126|BG001|Baseline|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
11043548|NCT01270126|BG002|Baseline|Total|Total of all reporting groups
11043549|NCT01270126|FG000|Participant Flow|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
11043550|NCT01270126|FG001|Participant Flow|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
11043551|NCT01270126|OG000|Outcome|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
11043552|NCT01270126|OG001|Outcome|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
11043553|NCT01270126|EG000|Reported Event|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
11043554|NCT01270126|EG001|Reported Event|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
11043555|NCT01270139|BG000|Baseline|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
11043556|NCT01270139|BG001|Baseline|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
11043557|NCT01270139|BG002|Baseline|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
11043558|NCT01270139|BG003|Baseline|Total|Total of all reporting groups
11043559|NCT01270139|FG000|Participant Flow|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
11043560|NCT01270139|FG001|Participant Flow|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
11043561|NCT01270139|FG002|Participant Flow|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
11149149|NCT01868997|EG000|Reported Event|Safety Population: Placebo|"A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.~Safety Population: participants who received at least 1 dose of study treatment, grouped by treatment actually received."
10887309|NCT00499681|OG000|Outcome|Part I and Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with lapatinib and 14 weeks treatment with letrozole and lapatinib
11043562|NCT01270139|OG000|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
11043563|NCT01270139|OG001|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
11043564|NCT01270139|OG002|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
11043565|NCT01270139|OG000|Outcome|Nano Group|60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/
11043566|NCT01270139|OG001|Outcome|Ferro Group|60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP. NP were detonated with NIR laser under the protection of anti-platelet therapy. Transplantation of iron-bearing nanoparticles: 60 - int
11043567|NCT01270139|OG002|Outcome|Stenting Control|"In case of control group (stenting control), XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.~Stenting: 60 - in sirolimus-eluting stenting control"
11043568|NCT01270139|OG000|Outcome|Nano Group|60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. NP were activated with NIR laser at 7 days after the intervention. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/15-70/40 nm silica-gold nanoparticles (NPs) transplanted by endoscopic cardiac surgery in the composition of bioengineered on-artery patch grown on the basis of biopolymeric scaffold and host circulating CD45-CD34-CD73+CD105+ progenitor cells
11149150|NCT01868997|EG001|Reported Event|Safety Population: Teprotumumab|"Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.~Safety Population: participants who received at least 1 dose of study treatment, grouped by treatment actually received."
11149151|NCT01869075|BG000|Baseline|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11043569|NCT01270139|OG001|Outcome|Ferro Group|"60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction. NP were detonated with NIR laser under the protection of anti-platelet therapy.~Transplantation of iron-bearing nanoparticles: 60 - into ferro-magnetic group with 60/15-70/40 nm silica-gold iron-bearing NPs with delivery in hand of magnetic navigation system"
11043570|NCT01270139|OG000|Outcome|Exposure of Nanoparticles|Blood for ex-vivo cytotoxic analysis (20.0 ml from a random patient) was collected for analysis at the Center for Modern Nanotechnologies of the Ural Federal University from the random naive patients to the BD Vacutainer (NJ, USA) plastic heparin tubes (spray-coated) with 150 USP units of sodium heparin per 10.0 ml, and then diluted by 0.1 g/l silica-gold NPs.
11043571|NCT01270139|OG001|Outcome|Sham|Blood for ex-vivo cytotoxic analysis (20.0 ml from a random patient) was collected for analysis at the Center for Modern Nanotechnologies of the Ural Federal University from the random naive patients to the BD Vacutainer (NJ, USA) plastic heparin tubes (spray-coated) with 150 USP units of sodium heparin per 10.0 ml, and then diluted by saline.
11043572|NCT01270139|EG000|Reported Event|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
11043573|NCT01270139|EG001|Reported Event|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
11043574|NCT01270139|EG002|Reported Event|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
11043575|NCT01270256|BG000|Baseline|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
11043576|NCT01270256|BG001|Baseline|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
11043577|NCT01270256|BG002|Baseline|Total|Total of all reporting groups
11043578|NCT01270256|FG000|Participant Flow|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
11043579|NCT01270256|FG001|Participant Flow|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
11043580|NCT01270256|OG000|Outcome|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
11043581|NCT01270256|OG001|Outcome|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
11043582|NCT01270256|EG000|Reported Event|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
11043583|NCT01270256|EG001|Reported Event|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
11043584|NCT01270321|BG000|Baseline|Arm A (Everolimus Alone)|"CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression~Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)"
11043585|NCT01270321|BG001|Baseline|Arm B (Pasireotide Alone)|"CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression~Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks"
11043586|NCT01270321|BG002|Baseline|Arm C (Everolimus + Pasireotide)|"CURRENTLY CLOSED TO ACCRUAL~Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks"
11043587|NCT01270321|BG003|Baseline|Total|Total of all reporting groups
11043588|NCT01270321|FG000|Participant Flow|Arm A (Everolimus Alone)|"CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression~Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)"
10887310|NCT00499681|OG001|Outcome|Part 1: Letrozole Plus Placebo Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with a placebo and 14 weeks treatment with letrozole and lapatinib
11043589|NCT01270321|FG001|Participant Flow|Arm B (Pasireotide Alone)|"CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression~Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks"
11043590|NCT01270321|FG002|Participant Flow|Arm C (Everolimus + Pasireotide)|"CURRENTLY CLOSED TO ACCRUAL~Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks"
11043591|NCT01270321|OG000|Outcome|Arm A (Everolimus Alone)|"CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression~Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)~Most frequent adverse events in >20% of patients:~Dry skin~Dysgeusia~Hypoalbuminemia~Joint Pain~Cough~Diarrhea~Hypercholesterolemia~Hypertriglceridemia~Hypokalemia~Hyponatremiapnia~Mucositis~Rash~Thrombocyto"
11043592|NCT01270321|OG001|Outcome|Arm B (Pasireotide Alone)|"CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression~Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks.~Most frequent adverse events in >20% of patients:~Hyperbilirubinemia~Hypertriglyceridemia~Hypercholesterolemia"
11043593|NCT01270321|OG002|Outcome|Arm C (Everolimus + Pasireotide)|"CURRENTLY CLOSED TO ACCRUAL~Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks.~Most frequent adverse events in >20% of patients:~Hypercholesterolemia~Anemia~Headache~Decreased Appetite~Cough~Mucositis~Hyponatremia"
11043594|NCT01270321|EG000|Reported Event|Arm A (Everolimus Alone)|"CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression~Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)"
11043595|NCT01270321|EG001|Reported Event|Arm B (Pasireotide Alone)|"CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression~Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks"
11043596|NCT01270321|EG002|Reported Event|Arm C (Everolimus + Pasireotide)|"CURRENTLY CLOSED TO ACCRUAL~Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks"
11043597|NCT01270464|BG000|Baseline|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
11043598|NCT01270464|BG001|Baseline|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
11043599|NCT01270464|BG002|Baseline|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
11043600|NCT01270464|BG003|Baseline|Total|Total of all reporting groups
11043601|NCT01270464|FG000|Participant Flow|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
11043602|NCT01270464|FG001|Participant Flow|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
11043603|NCT01270464|FG002|Participant Flow|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
11043604|NCT01270464|OG000|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
11043605|NCT01270464|OG001|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
11043606|NCT01270464|OG002|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
11043607|NCT01270464|EG000|Reported Event|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
11043608|NCT01270464|EG001|Reported Event|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
11043609|NCT01270464|EG002|Reported Event|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
11043610|NCT01270503|BG000|Baseline|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
11043611|NCT01270503|FG000|Participant Flow|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
11043612|NCT01270503|OG000|Outcome|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
11043613|NCT01270503|OG000|Outcome|Menactra® Vaccine Group|Participants received a single dose of Menactra vaccine
11043614|NCT01270503|EG000|Reported Event|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
11043615|NCT01270516|BG000|Baseline|Control, to be Given Saline Solution|"Intervention: This group will be given saline (30 ml every 12 hours) for 10 days~Saline: Control"
11043616|NCT01270516|BG001|Baseline|EPA, Eicosapentaenoic Acid|"This group will be given 1000 mg EPA every 12 hours for 10 days~EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days"
11043617|NCT01270516|BG002|Baseline|HMB, Hydroxymethylbutyrate|"This arm will be given HMB (1500 mg) every 12 hours for 10 days.~HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days"
11043618|NCT01270516|BG003|Baseline|EPA and HMB|"Intervention: This group will be given EPA (1000 mg every 12 hours given via the GI tract) and HMB (1500 mg every 12 hours given via the GI tract) for 10 days.~HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days~EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days"
11043619|NCT01270516|BG004|Baseline|Total|Total of all reporting groups
11043620|NCT01270516|FG000|Participant Flow|Control, to be Given Saline Solution|"Intervention: This group will be given saline (30 ml every 12 hours) for 10 days~Saline: Control"
11043621|NCT01270516|FG001|Participant Flow|EPA, Eicosapentaenoic Acid|"This group will be given 1000 mg EPA every 12 hours for 10 days~EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days"
11149152|NCT01869075|BG001|Baseline|AMI - Usual Care|Usual care as provided at the hospital.
11043622|NCT01270516|FG002|Participant Flow|HMB, Hydroxymethylbutyrate|"This arm will be given HMB (1500 mg) every 12 hours for 10 days.~HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days"
11043623|NCT01270516|FG003|Participant Flow|EPA and HMB|"Intervention: This group will be given EPA (1000 mg every 12 hours given via the GI tract) and HMB (1500 mg every 12 hours given via the GI tract) for 10 days.~HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days~EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days"
11043624|NCT01270516|OG000|Outcome|Control, to be Given Saline Solution|"Intervention: This group will be given saline (30 ml every 12 hours) for 10 days~Saline: Control"
11043625|NCT01270516|OG001|Outcome|EPA, Eicosapentaenoic Acid|"This group will be given 1000 mg EPA every 12 hours for 10 days~EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days"
11043626|NCT01270516|OG002|Outcome|HMB, Hydroxymethylbutyrate|"This arm will be given HMB (1500 mg) every 12 hours for 10 days.~HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days"
11043627|NCT01270516|OG003|Outcome|EPA and HMB|"Intervention: This group will be given EPA (1000 mg every 12 hours given via the GI tract) and HMB (1500 mg every 12 hours given via the GI tract) for 10 days.~HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days~EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days"
11043628|NCT01270516|EG000|Reported Event|Control, to be Given Saline Solution|"Intervention: This group will be given saline (30 ml every 12 hours) for 10 days~Saline: Control"
11043629|NCT01270516|EG001|Reported Event|EPA, Eicosapentaenoic Acid|"This group will be given 1000 mg EPA every 12 hours for 10 days~EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days"
11043630|NCT01270516|EG002|Reported Event|HMB, Hydroxymethylbutyrate|"This arm will be given HMB (1500 mg) every 12 hours for 10 days.~HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days"
11043631|NCT01270516|EG003|Reported Event|EPA and HMB|"Intervention: This group will be given EPA (1000 mg every 12 hours given via the GI tract) and HMB (1500 mg every 12 hours given via the GI tract) for 10 days.~HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days~EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days"
11043632|NCT01270529|BG000|Baseline|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043633|NCT01270529|BG001|Baseline|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043634|NCT01270529|BG002|Baseline|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043635|NCT01270529|BG003|Baseline|Total|Total of all reporting groups
11043636|NCT01270529|FG000|Participant Flow|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043637|NCT01270529|FG001|Participant Flow|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043638|NCT01270529|FG002|Participant Flow|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043639|NCT01270529|OG000|Outcome|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11149153|NCT01869075|BG002|Baseline|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11043640|NCT01270529|OG001|Outcome|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043641|NCT01270529|OG002|Outcome|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043642|NCT01270529|EG000|Reported Event|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043643|NCT01270529|EG001|Reported Event|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043644|NCT01270529|EG002|Reported Event|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
11043645|NCT01270542|BG000|Baseline|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
11043646|NCT01270542|BG001|Baseline|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
11043647|NCT01270542|BG002|Baseline|Total|Total of all reporting groups
11043648|NCT01270542|FG000|Participant Flow|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
11043649|NCT01270542|FG001|Participant Flow|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
11043650|NCT01270542|OG000|Outcome|Avastin (Bevacizumab)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
11043651|NCT01270542|OG001|Outcome|Sham Injection|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
11043652|NCT01270542|EG000|Reported Event|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
11043653|NCT01270542|EG001|Reported Event|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
11043654|NCT01270555|BG000|Baseline|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
11043655|NCT01270555|FG000|Participant Flow|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
11043656|NCT01270555|OG000|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
11043657|NCT01270555|EG000|Reported Event|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
11043658|NCT01270620|BG000|Baseline|Desflurane|"Patients received propofol or desflurane as general anesthetic for total knee replacement.~Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
11043659|NCT01270620|BG001|Baseline|Propofol|"Patients received propofol or desflurane as general anesthetic for total knee replacement.~Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
11043660|NCT01270620|BG002|Baseline|Total|Total of all reporting groups
11043661|NCT01270620|FG000|Participant Flow|Desflurane Group|"Patients will receive desflurane as general anesthetic. Desflurane is inhaled agent which will be provided continuously via ETT in concentrations varying from 4-6% according to BIS monitoring.~Desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
11043662|NCT01270620|FG001|Participant Flow|Propofol Group|"Patients will receive propofol as general anesthetic Propofol is an intravenous agent which will be provided continuously via IV in doses varying from 100 to 200 mcg/kg/min according to BIS monitoring.~Propofol: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
11043663|NCT01270620|OG000|Outcome|Desflurane|"Patients received desflurane as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
11043664|NCT01270620|OG001|Outcome|Propofol|"Patients received propofol as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
11043665|NCT01270620|OG000|Outcome|Desflurane|Patients received desflurane as general anesthetic
11043666|NCT01270620|OG001|Outcome|Propofol|Patients received propofol as general anesthetic
11043667|NCT01270620|OG000|Outcome|Desflurane|Patient received desflurane as a general anesthesia
11043668|NCT01270620|OG001|Outcome|Propofol|Patient received propofol as a general anesthesia
11043669|NCT01270620|OG000|Outcome|Desflurane|Patients received desflurane as a general anesthetic
11043670|NCT01270620|OG001|Outcome|Propofol|Patients received propofol as a general anesthetic
11043671|NCT01270620|EG000|Reported Event|Desflurane|"Patients will receive desflurane as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
11043672|NCT01270620|EG001|Reported Event|Propofol|"Patients will receive propofol as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
11043673|NCT01270659|BG000|Baseline|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
11043674|NCT01270659|BG001|Baseline|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
11043675|NCT01270659|BG002|Baseline|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
11043676|NCT01270659|BG003|Baseline|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
11043677|NCT01270659|BG004|Baseline|Total|Total of all reporting groups
11043678|NCT01270659|FG000|Participant Flow|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
11043679|NCT01270659|FG001|Participant Flow|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
11043680|NCT01270659|FG002|Participant Flow|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
11043681|NCT01270659|FG003|Participant Flow|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
11043682|NCT01270659|OG000|Outcome|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
11043683|NCT01270659|OG001|Outcome|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
11043684|NCT01270659|OG002|Outcome|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
11043685|NCT01270659|OG003|Outcome|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
11043686|NCT01270659|EG000|Reported Event|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
11043687|NCT01270659|EG001|Reported Event|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
11043688|NCT01270659|EG002|Reported Event|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
11043689|NCT01270659|EG003|Reported Event|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
11043690|NCT01270711|BG000|Baseline|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
11043691|NCT01270711|BG001|Baseline|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
11043692|NCT01270711|BG002|Baseline|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
11043693|NCT01270711|BG003|Baseline|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
11043694|NCT01270711|BG004|Baseline|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
11043695|NCT01270711|BG005|Baseline|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
11043696|NCT01270711|BG006|Baseline|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
11149154|NCT01869075|BG003|Baseline|MGS - Usual Care|Usual Care as provided at the hospital.
11043697|NCT01270711|BG007|Baseline|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
11043698|NCT01270711|BG008|Baseline|Total|Total of all reporting groups
11043699|NCT01270711|FG000|Participant Flow|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
11043700|NCT01270711|FG001|Participant Flow|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
11043701|NCT01270711|FG002|Participant Flow|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
11043702|NCT01270711|FG003|Participant Flow|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
11043703|NCT01270711|FG004|Participant Flow|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
11043704|NCT01270711|FG005|Participant Flow|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
11043705|NCT01270711|FG006|Participant Flow|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
11043706|NCT01270711|FG007|Participant Flow|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
11336596|NCT03569098|BG000|Baseline|Placebo|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of placebo (matching with Dysport) intramuscular injection distributed between 4 injection points in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
10887311|NCT00499681|EG000|Reported Event|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
11043707|NCT01270711|OG000|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
11043708|NCT01270711|OG001|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
11043709|NCT01270711|OG002|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
11043710|NCT01270711|OG003|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
11043711|NCT01270711|OG004|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
11043712|NCT01270711|OG002|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
11043713|NCT01270711|OG000|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
11043714|NCT01270711|OG001|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
11043715|NCT01270711|OG002|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
11043716|NCT01270711|EG000|Reported Event|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
11043717|NCT01270711|EG001|Reported Event|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
11043718|NCT01270711|EG002|Reported Event|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
11043719|NCT01270711|EG003|Reported Event|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
11043720|NCT01270711|EG004|Reported Event|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
11043721|NCT01270711|EG005|Reported Event|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
11043722|NCT01270711|EG006|Reported Event|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
11043723|NCT01270711|EG007|Reported Event|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
11043724|NCT01270802|BG000|Baseline|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
11043725|NCT01270802|BG001|Baseline|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir~Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
11043726|NCT01270802|BG002|Baseline|Total|Total of all reporting groups
11043727|NCT01270802|FG000|Participant Flow|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz (as Atripla) one pill per day
11043728|NCT01270802|FG001|Participant Flow|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/raltegravir : Tenofovir/emtricitabine/efavirenz (as Atripla one pill per day) will be switched to tenofovir/emtricitabine (as Truvada one pill per day) plus raltegravir (as Isentress) 400mg orally twice daily
11043729|NCT01270802|OG000|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
11043730|NCT01270802|OG001|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
11043731|NCT01270802|OG001|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/efavirenz will be switched to tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
11043732|NCT01270802|EG000|Reported Event|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
11043733|NCT01270802|EG001|Reported Event|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir~Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
11043734|NCT01270828|BG000|Baseline|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
11043735|NCT01270828|BG001|Baseline|Placebo DB|Participants received matching placebo
11043736|NCT01270828|BG002|Baseline|Total|Total of all reporting groups
11043737|NCT01270828|FG000|Participant Flow|Pregabalin Controlled Release (CR) DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
11043738|NCT01270828|FG001|Participant Flow|Placebo DB|Participants received matching placebo
11043739|NCT01270828|FG002|Participant Flow|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
11043740|NCT01270828|OG000|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
11043741|NCT01270828|OG001|Outcome|Placebo DB|Participants received matching placebo
11043742|NCT01270828|OG002|Outcome|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
11043743|NCT01270828|EG000|Reported Event|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
11043744|NCT01270828|EG001|Reported Event|Placebo DB|Participants received matching placebo
11043745|NCT01270828|EG002|Reported Event|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
11043746|NCT01270841|BG000|Baseline|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
11043747|NCT01270841|BG001|Baseline|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
11043748|NCT01270841|BG002|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
11043749|NCT01270841|BG003|Baseline|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
11043750|NCT01270841|BG004|Baseline|Total|Total of all reporting groups
11043751|NCT01270841|FG000|Participant Flow|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
11043752|NCT01270841|FG001|Participant Flow|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
11043753|NCT01270841|FG002|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
11043754|NCT01270841|FG003|Participant Flow|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
11043755|NCT01270841|OG000|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
11043756|NCT01270841|OG001|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
11043757|NCT01270841|OG002|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
11043758|NCT01270841|OG003|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
11043759|NCT01270841|EG000|Reported Event|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
11043760|NCT01270841|EG001|Reported Event|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
11043761|NCT01270841|EG002|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
11043762|NCT01270841|EG003|Reported Event|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
11043763|NCT01270867|BG000|Baseline|Merci Retriever|Patients who were randomized to the Merci Retriever
11043764|NCT01270867|BG001|Baseline|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
11043765|NCT01270867|BG002|Baseline|Total|Total of all reporting groups
11043766|NCT01270867|FG000|Participant Flow|Merci Retriever|Patients who were randomized to the Merci Retriever
11043767|NCT01270867|FG001|Participant Flow|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
11043768|NCT01270867|OG000|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
11043769|NCT01270867|OG001|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
11043770|NCT01270867|EG000|Reported Event|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
11043771|NCT01270867|EG001|Reported Event|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
11043772|NCT01270880|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
11043773|NCT01270880|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
11043774|NCT01270880|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
11043775|NCT01270880|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
11043776|NCT01270958|BG000|Baseline|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
11043777|NCT01270958|FG000|Participant Flow|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
11043778|NCT01270958|OG000|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
11043779|NCT01270958|EG000|Reported Event|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
11043780|NCT01270971|BG000|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
11043781|NCT01270971|BG001|Baseline|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
11043782|NCT01270971|BG002|Baseline|Total|Total of all reporting groups
11043783|NCT01270971|FG000|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
11043784|NCT01270971|FG001|Participant Flow|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
11043785|NCT01270971|OG000|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
11043786|NCT01270971|OG001|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
11043787|NCT01270971|EG000|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
11043788|NCT01270971|EG001|Reported Event|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
11043789|NCT01271010|BG000|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
11043790|NCT01271010|FG000|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
11043791|NCT01271010|OG000|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
11043792|NCT01271010|EG000|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
11043793|NCT01271036|BG000|Baseline|Male|Male Participants
11043794|NCT01271036|BG001|Baseline|Female|Female Participants
11043795|NCT01271036|BG002|Baseline|Total|Total of all reporting groups
11043796|NCT01271036|FG000|Participant Flow|Males|Male Participants (K-Y Brand TOUCH 2-in-1)
11043797|NCT01271036|FG001|Participant Flow|Female|Female Participants (K-Y Brand TOUCH 2-in-1)
11043798|NCT01271036|OG000|Outcome|Male|Male Participants
11043799|NCT01271036|OG001|Outcome|Female|Female Participants
11043800|NCT01271036|EG000|Reported Event|Male|Male Participants
11043801|NCT01271036|EG001|Reported Event|Female|Female Participants
11043802|NCT01271244|BG000|Baseline|PTSD Depression Group|Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks
11043803|NCT01271244|BG001|Baseline|Major Depression Group|Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
11043804|NCT01271244|BG002|Baseline|Total|Total of all reporting groups
11043805|NCT01271244|FG000|Participant Flow|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
11043806|NCT01271244|FG001|Participant Flow|Major Depression Group|Veteran with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
11043807|NCT01271244|OG000|Outcome|PTSD Depression Group|Veterans with PTSD and depression receive Escitalopram: 10-20mg daily for 12 weeks
11043808|NCT01271244|OG001|Outcome|Major Depression Group|Veterans with major depression receive Escitalopram: 10-20mg daily for 12 weeks
11043809|NCT01271244|EG000|Reported Event|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
11043810|NCT01271244|EG001|Reported Event|Major Depression Group|Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks
11043811|NCT01271413|BG000|Baseline|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
11043812|NCT01271413|BG001|Baseline|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
11043813|NCT01271413|BG002|Baseline|Total|Total of all reporting groups
11043814|NCT01271413|FG000|Participant Flow|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
11043815|NCT01271413|FG001|Participant Flow|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
11043816|NCT01271413|OG000|Outcome|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
11043817|NCT01271413|OG001|Outcome|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
11043818|NCT01271413|EG000|Reported Event|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
11043819|NCT01271413|EG001|Reported Event|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
11043820|NCT01271452|BG000|Baseline|Vistabel®|botulinum toxin type A (Vistabel®)
11043821|NCT01271452|BG001|Baseline|Bocouture®|botulinum toxin type A (Bocouture®)
11043822|NCT01271452|BG002|Baseline|Total|Total of all reporting groups
11043823|NCT01271452|FG000|Participant Flow|Vistabel®|botulinum toxin type A (Vistabel®)
11043824|NCT01271452|FG001|Participant Flow|Bocouture®|botulinum toxin type A (Bocouture®)
11043825|NCT01271452|OG000|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
11043826|NCT01271452|OG001|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
11043827|NCT01271452|EG000|Reported Event|Vistabel®|botulinum toxin type A (Vistabel®)
11043828|NCT01271452|EG001|Reported Event|Bocouture®|botulinum toxin type A (Bocouture®)
11043829|NCT01271504|BG000|Baseline|Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 513 Days).
11043830|NCT01271504|BG001|Baseline|Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg|Participants received golvatinib 300 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 513 Days).
11043831|NCT01271504|BG002|Baseline|Phase 2: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 Days).
11043832|NCT01271504|BG003|Baseline|Phase 2: Sorafenib 400 mg|Participants received sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 Days).
11043833|NCT01271504|BG004|Baseline|Total|Total of all reporting groups
11043834|NCT01271504|FG000|Participant Flow|Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 milligram (mg), tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 513 Days).
11043835|NCT01271504|FG001|Participant Flow|Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg|Participants received golvatinib 300 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 513 Days).
11043836|NCT01271504|FG002|Participant Flow|Phase 2: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 Days).
11043837|NCT01271504|FG003|Participant Flow|Phase 2: Sorafenib 400 mg|Participants received sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 Days).
11043838|NCT01271504|OG000|Outcome|Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 513 Days).
11043839|NCT01271504|OG001|Outcome|Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg|Participants received golvatinib 300 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 513 Days).
11043840|NCT01271504|OG000|Outcome|Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once in combination with sorafenib 400 mg, tablet, orally twice on Day-7.
11043841|NCT01271504|OG001|Outcome|Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg|Participants received golvatinib 300 mg, tablet, orally, once in combination with sorafenib 400 mg, tablet, orally twice on Day-7.
11043842|NCT01271504|OG000|Outcome|Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice on Day 1 of Cycle 1.
11043843|NCT01271504|OG001|Outcome|Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg|Participants received golvatinib 300 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice on Day 1 of Cycle 1.
11043844|NCT01271504|OG000|Outcome|Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily from Day 1 to 28 of Cycle 1.
11043845|NCT01271504|OG001|Outcome|Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg|Participants received golvatinib 300 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily from Day 1 to 28 of Cycle 1.
11043846|NCT01271504|OG000|Outcome|Phase 2: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 Days).
11043847|NCT01271504|OG001|Outcome|Phase 2: Sorafenib 400 mg|Participants received sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 Days).
11043848|NCT01271504|OG000|Outcome|Phase 2: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 days).
11043849|NCT01271504|OG001|Outcome|Phase 2: Sorafenib 400 mg|Participants received sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 days).
11043850|NCT01271504|OG000|Outcome|Phase 2: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
11043851|NCT01271504|OG001|Outcome|Phase 2: Sorafenib 400 mg|Participants received sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
11043852|NCT01271504|EG000|Reported Event|Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 513 days).
11043853|NCT01271504|EG001|Reported Event|Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg|Participants received golvatinib 300 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 513 days).
11043854|NCT01271504|EG002|Reported Event|Phase 2: Golvatinib 200 mg + Sorafenib 400 mg|Participants received golvatinib 200 mg, tablet, orally, once daily in combination with sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 days).
11043855|NCT01271504|EG003|Reported Event|Phase 2: Sorafenib 400 mg|Participants received sorafenib 400 mg, tablet, orally, twice daily in 28-days treatment cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first (Up to 705 days).
11043856|NCT01271543|BG000|Baseline|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11043857|NCT01271543|BG001|Baseline|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11043858|NCT01271543|BG002|Baseline|Total|Total of all reporting groups
11043859|NCT01271543|FG000|Participant Flow|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11149155|NCT01869075|BG004|Baseline|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11149156|NCT01869075|BG005|Baseline|HFS - Usual Care|Usual Care as provided at the hospital.
11043860|NCT01271543|FG001|Participant Flow|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11043861|NCT01271543|OG000|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11043862|NCT01271543|OG001|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11043863|NCT01271543|OG000|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11043864|NCT01271543|EG000|Reported Event|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11043865|NCT01271543|EG001|Reported Event|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
11043866|NCT01271686|BG000|Baseline|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks
11043867|NCT01271686|FG000|Participant Flow|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
11043868|NCT01271686|OG000|Outcome|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
11043869|NCT01271686|EG000|Reported Event|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
11043870|NCT01271712|BG000|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11043871|NCT01271712|BG001|Baseline|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11043872|NCT01271712|BG002|Baseline|Total|Total of all reporting groups
11043873|NCT01271712|FG000|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11043874|NCT01271712|FG001|Participant Flow|Placebo First, Then Option of Open Label Regorafenib Treatment|Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
11043875|NCT01271712|OG000|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11043876|NCT01271712|OG001|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11149157|NCT01869075|BG006|Baseline|Total|Total of all reporting groups
11043877|NCT01271712|EG000|Reported Event|Regorafenib (Double Blind Only)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11043878|NCT01271712|EG001|Reported Event|Placebo (Double Blind Only)|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11043879|NCT01271712|EG002|Reported Event|Placebo, Open Label Only (Switch to Regorafenib)|Participants switched to Open-label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks
11043880|NCT01271712|EG003|Reported Event|Treated With Regorafenib at Any Time|Treated with Regorafenib at any time: At any time, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11043881|NCT01271712|EG004|Reported Event|Treated With Regorafenib for > 1 Year|Treated with Regorafenib for > 1 year: For more than a year, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
11043882|NCT01271725|BG000|Baseline|Afatinib Monotherapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.
11043883|NCT01271725|FG000|Participant Flow|Afatinib Monotherapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.
11043884|NCT01271725|FG001|Participant Flow|Afatinib and Paclitaxel or Vinorelbine Combination Therapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
11043885|NCT01271725|OG000|Outcome|Afatinib Monotherapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.
11043886|NCT01271725|OG001|Outcome|Afatinib and Paclitaxel or Vinorelbine Combination Therapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
11043887|NCT01271725|OG001|Outcome|Afatinib and Vinorelbine Combination Therapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
11043888|NCT01271725|OG002|Outcome|Afatinib and Paclitaxel Combination Therapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
11043889|NCT01271725|EG000|Reported Event|Afatinib Monotherapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.
11043890|NCT01271725|EG001|Reported Event|Afatinib and Vinorelbine Combination Therapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
11043891|NCT01271725|EG002|Reported Event|Afatinib and Paclitaxel Combination Therapy|Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
11043892|NCT01271803|BG000|Baseline|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043893|NCT01271803|BG001|Baseline|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043894|NCT01271803|BG002|Baseline|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043895|NCT01271803|BG003|Baseline|Total|Total of all reporting groups
11043896|NCT01271803|FG000|Participant Flow|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043897|NCT01271803|FG001|Participant Flow|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043898|NCT01271803|FG002|Participant Flow|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043899|NCT01271803|OG000|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043900|NCT01271803|OG001|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043901|NCT01271803|OG002|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043902|NCT01271803|OG003|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043903|NCT01271803|OG004|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043904|NCT01271803|OG005|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043905|NCT01271803|OG006|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043906|NCT01271803|OG007|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043907|NCT01271803|OG008|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043908|NCT01271803|OG000|Outcome|Dose Escalation Stage (Stage 1)|All participants who received vemurafenib and cobimetinib in any dose combination during DES, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043909|NCT01271803|OG007|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043910|NCT01271803|OG008|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043911|NCT01271803|OG009|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043912|NCT01271803|OG000|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043913|NCT01271803|OG009|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043914|NCT01271803|OG010|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043915|NCT01271803|OG003|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043916|NCT01271803|OG004|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043917|NCT01271803|OG005|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043918|NCT01271803|OG006|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043919|NCT01271803|OG007|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043920|NCT01271803|OG000|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043921|NCT01271803|OG001|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043922|NCT01271803|OG004|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043923|NCT01271803|OG005|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043924|NCT01271803|OG006|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043925|NCT01271803|OG000|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043926|NCT01271803|OG001|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043927|NCT01271803|OG002|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10887312|NCT00499681|EG001|Reported Event|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
11043928|NCT01271803|OG003|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043929|NCT01271803|OG004|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043930|NCT01271803|OG005|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043931|NCT01271803|OG006|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043932|NCT01271803|OG000|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043933|NCT01271803|OG001|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043934|NCT01271803|OG002|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043935|NCT01271803|OG003|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043936|NCT01271803|OG004|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043937|NCT01271803|OG000|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043938|NCT01271803|OG001|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043939|NCT01271803|EG000|Reported Event|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043940|NCT01271803|EG001|Reported Event|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
11043941|NCT01271803|EG002|Reported Event|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11043942|NCT01271855|BG000|Baseline|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
11043943|NCT01271855|BG001|Baseline|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
11043944|NCT01271855|BG002|Baseline|Total|Total of all reporting groups
11043945|NCT01271855|FG000|Participant Flow|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
11043946|NCT01271855|FG001|Participant Flow|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
11043947|NCT01271855|OG000|Outcome|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
11043948|NCT01271855|OG001|Outcome|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
11043949|NCT01271855|EG000|Reported Event|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
11043950|NCT01271855|EG001|Reported Event|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
11043951|NCT01271868|BG000|Baseline|IB1001|PK study and Treatment Study
11043952|NCT01271868|FG000|Participant Flow|IB1001|
11043953|NCT01271868|OG000|Outcome|IB1001|Treatment phase: Prophylaxis treatment (n=8) and on demand treatment (n=1)
11043954|NCT01271868|OG000|Outcome|IB1001|PK phase
11043955|NCT01271868|OG000|Outcome|IB1001|Treatment study for those receiving prophylaxis treatment (n=8)
11043956|NCT01271868|EG000|Reported Event|IB1001|IB1001 Safety population includes all subjects who received at least one dose of IB1001
11043957|NCT01271907|BG000|Baseline|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
11043958|NCT01271907|BG001|Baseline|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
11043959|NCT01271907|BG002|Baseline|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
11043960|NCT01271907|BG003|Baseline|Total|Total of all reporting groups
11043961|NCT01271907|FG000|Participant Flow|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
11043962|NCT01271907|FG001|Participant Flow|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
11043963|NCT01271907|FG002|Participant Flow|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
11043964|NCT01271907|OG000|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
11043965|NCT01271907|OG001|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
11043966|NCT01271907|OG002|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
11043967|NCT01271907|EG000|Reported Event|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
11043968|NCT01271907|EG001|Reported Event|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
11043969|NCT01271907|EG002|Reported Event|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
11043970|NCT01271933|BG000|Baseline|Pregabalin (Single Blind Phase)|Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.
11043971|NCT01271933|FG000|Participant Flow|Pregabalin (Single Blind Phase)|Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.
11043972|NCT01271933|FG001|Participant Flow|Pregabalin (Double Blind Phase)|At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
11043973|NCT01271933|FG002|Participant Flow|Placebo (Double Blind Phase)|At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
11043974|NCT01271933|OG000|Outcome|Pregabalin (Double Blind Phase)|At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
11043975|NCT01271933|OG001|Outcome|Placebo (Double Blind Phase)|At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
11043976|NCT01271933|OG000|Outcome|Pregabalin (Single Blind Phase)|Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.
11043977|NCT01271933|OG001|Outcome|Pregabalin (Double Blind Phase)|At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
11043978|NCT01271933|OG002|Outcome|Placebo (Double Blind Phase)|At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
11043979|NCT01271933|EG000|Reported Event|Pregabalin (Single Blind Phase)|Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.
11043980|NCT01271933|EG001|Reported Event|Pregabalin (Double Blind Phase)|At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
11043981|NCT01271933|EG002|Reported Event|Placebo (Double Blind Phase)|At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
11043982|NCT01271946|BG000|Baseline|Intent to Treat|
11043983|NCT01271946|BG001|Baseline|Sheath Greater Than 6F|
11043984|NCT01271946|BG002|Baseline|Total|Total of all reporting groups
11043985|NCT01271946|FG000|Participant Flow|Intent to Treat (ITT)|The ITT cohort consists of those subjects where an attempt was made to place the Arstasis device into subject's vasculature regardless of whether or not this attempt was successful.
11043986|NCT01271946|FG001|Participant Flow|Sheath Greater Than 6 French (F)|Subjects in whom the procedural sheath was upsized to greater than 6F.
11043987|NCT01271946|OG000|Outcome|Intent to Treat|Major access site-related complications observed in the intent-to-treat population.
11043988|NCT01271946|OG001|Outcome|Sheath Greater Than 6F|Major access site-related complications observed in subjects treated with sheath size greater than 6F.
11043989|NCT01271946|OG000|Outcome|Intent to Treat|
11043990|NCT01271946|OG001|Outcome|Sheath Greater Than 6F|
11043991|NCT01271946|OG000|Outcome|Group 1|Minor access site-related complications observed in the intent-to-treat population.
11043992|NCT01271946|OG001|Outcome|Sheath Greater Than 6F|Minor access site-related complications observed in subjects who were upsized to sheath size greater than 6F.
11043993|NCT01271946|OG000|Outcome|Intent to Treat|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
11043994|NCT01271946|OG001|Outcome|Sheath Greater Than 6F|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
11043995|NCT01271946|OG000|Outcome|Group 1|Time to Discharge Eligibility was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
11043996|NCT01271946|OG000|Outcome|Intent to Treat|Time to Actual Discharge was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
11043997|NCT01271946|OG000|Outcome|Intent to Treat|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
11043998|NCT01271946|OG001|Outcome|Sheath Greater Than 6F|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
11043999|NCT01271946|OG000|Outcome|Intent to Treat|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
11044000|NCT01271946|OG001|Outcome|Sheath Greater Than 6F|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
11044001|NCT01271946|OG000|Outcome|Per Protocol|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
11044002|NCT01271946|OG000|Outcome|Per Protocol|Time to Ambulation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
11044003|NCT01271946|EG000|Reported Event|Intent to Treat|
11044004|NCT01271946|EG001|Reported Event|Sheath Greater Than 6F|
11044005|NCT01272011|BG000|Baseline|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
11044006|NCT01272011|BG001|Baseline|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
11044007|NCT01272011|BG002|Baseline|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
11044008|NCT01272011|BG003|Baseline|Total|Total of all reporting groups
11044009|NCT01272011|FG000|Participant Flow|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
11044010|NCT01272011|FG001|Participant Flow|Phase 2 Arm (LTF)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
11044011|NCT01272011|FG002|Participant Flow|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
11149158|NCT01869075|FG000|Participant Flow|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11044012|NCT01272011|OG000|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.~Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
11044013|NCT01272011|OG001|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
11044014|NCT01272011|OG002|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
11044015|NCT01272011|EG000|Reported Event|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
11044016|NCT01272011|EG001|Reported Event|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
11044017|NCT01272011|EG002|Reported Event|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
11044018|NCT01272076|BG000|Baseline|GA Group|Patients diagnosed with dry AMD and geographic atrophy
11044019|NCT01272076|FG000|Participant Flow|Dry AMD With Geographic Atrophy|Patients diagnosed with dry AMD and geographic atrophy
11044020|NCT01272076|OG000|Outcome|GA Group|Inter-device variability in measuring the area of Geographic Atrophy. 3 acceptable scans from 3 Cirrus HD-OCT devices (total of 9) were taken by one operator in this phase.
11044021|NCT01272076|EG000|Reported Event|GA Group|Patients with dry age related macular degeneration and geographic atrophy.
11044022|NCT01272180|BG000|Baseline|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
11044023|NCT01272180|BG001|Baseline|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
11044024|NCT01272180|BG002|Baseline|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
11044025|NCT01272180|BG003|Baseline|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
11044026|NCT01272180|BG004|Baseline|Total|Total of all reporting groups
11044027|NCT01272180|FG000|Participant Flow|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
11044028|NCT01272180|FG001|Participant Flow|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
11044029|NCT01272180|FG002|Participant Flow|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
11044030|NCT01272180|FG003|Participant Flow|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
11044031|NCT01272180|OG000|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
11044032|NCT01272180|OG001|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
11044033|NCT01272180|OG002|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
11044034|NCT01272180|OG002|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
11044035|NCT01272180|OG002|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
11044036|NCT01272180|OG002|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
11044037|NCT01272180|OG003|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
11044038|NCT01272180|OG002|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
11044039|NCT01272180|EG000|Reported Event|ABCWY+OMV|Subjects in this group received two doses of rMenB(+ OMV_full dose) and MenACWY combination vaccine, administered two months apart.
11044040|NCT01272180|EG001|Reported Event|ABCWY+qOMV|"Subjects in this group received two doses of rMenB (+ OMV_1/4th dose)~+and MenACWY combination vaccine, administered two months apart."
11044041|NCT01272180|EG002|Reported Event|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
11044042|NCT01272180|EG003|Reported Event|ACWY|Subjects in this group received first dose of placebo followed by one dose of MenACWY vaccine administered two months apart.
11044043|NCT01272193|BG000|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
11044044|NCT01272193|BG001|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
11044045|NCT01272193|BG002|Baseline|Total|Total of all reporting groups
11044046|NCT01272193|FG000|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
11149159|NCT01869075|FG001|Participant Flow|AMI - Usual Care|Usual care provided at the hospital
11044047|NCT01272193|FG001|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
11044048|NCT01272193|OG000|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
11044049|NCT01272193|OG001|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
11044050|NCT01272193|EG000|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
11044051|NCT01272193|EG001|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
11044052|NCT01272219|BG000|Baseline|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
11044053|NCT01272219|BG001|Baseline|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
11044054|NCT01272219|BG002|Baseline|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
11044055|NCT01272219|BG003|Baseline|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
11044056|NCT01272219|BG004|Baseline|Total|Total of all reporting groups
11044057|NCT01272219|FG000|Participant Flow|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
11044058|NCT01272219|FG001|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
11044059|NCT01272219|FG002|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
11044060|NCT01272219|FG003|Participant Flow|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
11044061|NCT01272219|FG004|Participant Flow|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
11044062|NCT01272219|FG005|Participant Flow|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
11044063|NCT01272219|OG000|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
11044064|NCT01272219|OG001|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
11044065|NCT01272219|OG000|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
11044066|NCT01272219|OG001|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
11044067|NCT01272219|OG000|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
11044068|NCT01272219|OG001|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
11044069|NCT01272219|OG002|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
11044070|NCT01272219|EG000|Reported Event|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
11044071|NCT01272219|EG001|Reported Event|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
11044072|NCT01272219|EG002|Reported Event|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
11044073|NCT01272219|EG003|Reported Event|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
11044074|NCT01272232|BG000|Baseline|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044075|NCT01272232|BG001|Baseline|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044076|NCT01272232|BG002|Baseline|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11226833|NCT02378402|OG000|Outcome|Unstable HF Group|"Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF<50%. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. We quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data."
11044077|NCT01272232|BG003|Baseline|Total|Total of all reporting groups
11044078|NCT01272232|FG000|Participant Flow|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044079|NCT01272232|FG001|Participant Flow|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044080|NCT01272232|FG002|Participant Flow|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044081|NCT01272232|OG000|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044082|NCT01272232|OG001|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044083|NCT01272232|OG002|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044084|NCT01272232|EG000|Reported Event|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044085|NCT01272232|EG001|Reported Event|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044086|NCT01272232|EG002|Reported Event|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
11044087|NCT01272245|BG000|Baseline|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
11044088|NCT01272245|FG000|Participant Flow|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
11044089|NCT01272245|OG000|Outcome|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
11044090|NCT01272245|EG000|Reported Event|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
11044091|NCT01272284|BG000|Baseline|Altis® SIS|Participants implanted with Altis® Single Incision Sling
11044092|NCT01272284|FG000|Participant Flow|Altis® SIS|Participants implanted with Altis® Single Incision Sling
11044093|NCT01272284|OG000|Outcome|Altis SIS®|Participants implanted with Altis® Single Incision Sling
11044094|NCT01272284|OG000|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
11044095|NCT01272284|EG000|Reported Event|Altis® SIS|Participants implanted with Altis® Single Incision Sling
11044096|NCT01272388|BG000|Baseline|Tadalafil|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044097|NCT01272388|BG001|Baseline|Placebo|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills daily is not tolerated, then the dose will be decreased back to 1 pill daily.
11044098|NCT01272388|BG002|Baseline|Total|Total of all reporting groups
11044099|NCT01272388|FG000|Participant Flow|Tadalafil|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044100|NCT01272388|FG001|Participant Flow|Placebo|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills daily is not tolerated, then the dose will be decreased back to 1 pill daily.
11044101|NCT01272388|OG000|Outcome|Tadalafil|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044102|NCT01272388|OG001|Outcome|Placebo|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills daily is not tolerated, then the dose will be decreased back to 1 pill daily.
11044103|NCT01272388|EG000|Reported Event|Tadalafil|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044104|NCT01272388|EG001|Reported Event|Placebo|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills daily is not tolerated, then the dose will be decreased back to 1 pill daily.
11044105|NCT01272583|BG000|Baseline|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
11044106|NCT01272583|BG001|Baseline|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
11044107|NCT01272583|BG002|Baseline|Total|Total of all reporting groups
11044108|NCT01272583|FG000|Participant Flow|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
11044109|NCT01272583|FG001|Participant Flow|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
11044110|NCT01272583|OG000|Outcome|Baseline|
11044111|NCT01272583|OG001|Outcome|Sitagliptin Treatment|
11044112|NCT01272583|OG002|Outcome|Placebo|
11044113|NCT01272583|EG000|Reported Event|Baseline|
11044114|NCT01272583|EG001|Reported Event|Sitagliptin Treatment|
11044115|NCT01272583|EG002|Reported Event|Placebo|
11066606|NCT01393392|EG000|Reported Event|Intensive, Tailored Intervention|"Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.~Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided."
11066607|NCT01393392|EG001|Reported Event|Control Intervention|"Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants.~NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit)."
11066608|NCT01393405|BG000|Baseline|Induction Period (Week 1-16)|Steroid taper for 12 weeks and 25 mg MTX sq once weekly + 1 mg folic acid daily
11066609|NCT01393405|FG000|Participant Flow|Induction Period (Week 1-16)|Steroid taper for 12 weeks and 25 mg MTX sq once weekly + 1 mg folic acid daily
11066610|NCT01393405|FG001|Participant Flow|Methotrexate Maintenance (Week 17-48)|25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
11066611|NCT01393405|FG002|Participant Flow|Placebo Maintenance (Week 17-48)|Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
11066612|NCT01393405|OG000|Outcome|Methotrexate Maintenance (Week 17-48)|"25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
11066613|NCT01393405|OG001|Outcome|Placebo Maintenance (Week 17-48)|"Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
11066614|NCT01393405|OG000|Outcome|Induction Period (Week 1-16)|All patients treated with open label methotrexate 25 mg/kg bodyweight for 16 weeks in the Induction Period and a steroid taper week 0-12.
11066615|NCT01393405|OG000|Outcome|Methotrexate Maintenance (Week 17-48)|25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
11066616|NCT01393405|OG001|Outcome|Placebo Maintenance (Week 17-48)|Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
11066617|NCT01393405|EG000|Reported Event|Induction Period (Week 1-16)|Steroid taper for 12 weeks and 25 mg MTX sq once weekly + 1 mg folic acid daily
11066618|NCT01393405|EG001|Reported Event|Methotrexate Maintenance (Week 17-48)|25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
11066619|NCT01393405|EG002|Reported Event|Placebo Maintenance (Week 17-48)|Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
11044116|NCT01272635|BG000|Baseline|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
11044117|NCT01272635|BG001|Baseline|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
11044118|NCT01272635|BG002|Baseline|Total|Total of all reporting groups
11044119|NCT01272635|FG000|Participant Flow|Azithromycin/Prednisolone|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
11044120|NCT01272635|FG001|Participant Flow|Azithromycin/Placebo|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
11044121|NCT01272635|FG002|Participant Flow|Placebo/Prednisolone|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
11044122|NCT01272635|FG003|Participant Flow|Placebo/Placebo|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
11044123|NCT01272635|OG000|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
11044124|NCT01272635|OG001|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
11044125|NCT01272635|OG000|Outcome|Prednisone|Active Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
11044126|NCT01272635|OG001|Outcome|Placebo|Placebo Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
11044127|NCT01272635|EG000|Reported Event|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
11044128|NCT01272635|EG001|Reported Event|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
11044129|NCT01272661|BG000|Baseline|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
11044130|NCT01272661|BG001|Baseline|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
11044131|NCT01272661|BG002|Baseline|Enhanced Curriculum+Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
11044132|NCT01272661|BG003|Baseline|Total|Total of all reporting groups
11044133|NCT01272661|FG000|Participant Flow|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
11044134|NCT01272661|FG001|Participant Flow|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
11044135|NCT01272661|FG002|Participant Flow|Enhanced Curriculum +Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
11044136|NCT01272661|OG000|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
11044137|NCT01272661|OG001|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
11044138|NCT01272661|OG002|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
11044139|NCT01272661|EG000|Reported Event|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
11044140|NCT01272661|EG001|Reported Event|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
11066620|NCT01393444|BG000|Baseline|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
11044141|NCT01272661|EG002|Reported Event|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
11044142|NCT01272804|BG000|Baseline|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
11044143|NCT01272804|BG001|Baseline|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
11044144|NCT01272804|BG002|Baseline|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
11044145|NCT01272804|BG003|Baseline|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
11044146|NCT01272804|BG004|Baseline|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
11044147|NCT01272804|BG005|Baseline|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
11044148|NCT01272804|BG006|Baseline|Total|Total of all reporting groups
11044149|NCT01272804|FG000|Participant Flow|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
11044150|NCT01272804|FG001|Participant Flow|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
11044151|NCT01272804|FG002|Participant Flow|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
11044152|NCT01272804|FG003|Participant Flow|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
11044153|NCT01272804|FG004|Participant Flow|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
11044154|NCT01272804|FG005|Participant Flow|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
11044155|NCT01272804|OG000|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
11044156|NCT01272804|OG001|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
11044157|NCT01272804|OG002|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
11044158|NCT01272804|OG003|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
11044159|NCT01272804|OG004|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
11044160|NCT01272804|OG005|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
11044161|NCT01272804|EG000|Reported Event|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
11044162|NCT01272804|EG001|Reported Event|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
11044163|NCT01272804|EG002|Reported Event|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
11044164|NCT01272804|EG003|Reported Event|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
11044165|NCT01272804|EG004|Reported Event|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
11044166|NCT01272804|EG005|Reported Event|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
11044167|NCT01272830|BG000|Baseline|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
11044168|NCT01272830|BG001|Baseline|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
11044169|NCT01272830|BG002|Baseline|Total|Total of all reporting groups
11044170|NCT01272830|FG000|Participant Flow|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
11044171|NCT01272830|FG001|Participant Flow|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
11044172|NCT01272830|OG000|Outcome|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
11044173|NCT01272830|OG001|Outcome|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
11044174|NCT01272830|EG000|Reported Event|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
11044175|NCT01272830|EG001|Reported Event|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
11044176|NCT01272869|BG000|Baseline|Sensura|The reference product is the SenSura product which is already commercially available
11044177|NCT01272869|BG001|Baseline|Morfeus|The test product is the product with the proposed new filter (Morfeus)
11044178|NCT01272869|BG002|Baseline|Total|Total of all reporting groups
11044179|NCT01272869|FG000|Participant Flow|Sensura First; Then Morfeus|The reference product is the SenSura product which is already commercially available
11044180|NCT01272869|FG001|Participant Flow|Morfeus First; Then Sensura|The test product with the Morfeus filter is the test product with the proposed new filter.
11044181|NCT01272869|OG000|Outcome|Sensura|SenSura is the reference product and the product is already commercially available
11044182|NCT01272869|OG001|Outcome|Morfeus|The test product is the product with the proposed new filter (Morfeus)
11044183|NCT01272869|EG000|Reported Event|Sensura|The reference product is the SenSura product which is already commercially available
11044184|NCT01272869|EG001|Reported Event|Morfeus|The test product is the product with the proposed new filter (Morfeus)
11044185|NCT01272882|BG000|Baseline|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
11044186|NCT01272882|FG000|Participant Flow|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
11044187|NCT01272882|OG000|Outcome|Adults With ARDS or ALI|Adults with PaO2/FiO2 ratio less than 300. Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device
11044188|NCT01272882|EG000|Reported Event|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
11044189|NCT01272908|BG000|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
11044190|NCT01272908|FG000|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg per week (mg/week) and a stable dose of folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (Disease Activity Score based on 28-Joint Count [DAS28] score of greater than or equal to [≥]2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg], given 14 days apart), at any time between Week 24 and 48.
11044191|NCT01272908|OG000|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
11044192|NCT01272908|OG000|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
11044193|NCT01272908|EG000|Reported Event|Initial Treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
11044194|NCT01272908|EG001|Reported Event|Re-treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
11044195|NCT01272921|BG000|Baseline|GROUP 1|"Varying does to determine duration of analgesia following a sciatic nerve block~Bupivacaine : Varying doses to determine the duration of analgesia"
11044196|NCT01272921|BG001|Baseline|GROUP 2|"Varying does to determine duration of analgesia following a sciatic nerve block~Ropivacaine : Varying doses to determine the duration of analgesia"
11044197|NCT01272921|BG002|Baseline|Total|Total of all reporting groups
11044198|NCT01272921|FG000|Participant Flow|Bupivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block~Bupivacaine : Varying doses to determine the duration of analgesia"
11044199|NCT01272921|FG001|Participant Flow|Ropivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block~Ropivacaine : Varying doses to determine the duration of analgesia"
11044200|NCT01272921|OG000|Outcome|Above CIEL|The mean threshold current required to elicit a motor response above the common investing extraneural layer (CIEL).
11044201|NCT01272921|OG001|Outcome|Below CIEL|The mean threshold current required to elicit a motor response below the common investing extraneural layer (CIEL).
11044202|NCT01272921|OG000|Outcome|Bupivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
11044203|NCT01272921|OG001|Outcome|Ropivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
11044204|NCT01272921|EG000|Reported Event|GROUP 1|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
11044205|NCT01272921|EG001|Reported Event|GROUP 2|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
11044206|NCT01272934|BG000|Baseline|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
11044207|NCT01272934|BG001|Baseline|Placebo|Placebo : Topical gel-4 times daily
11044208|NCT01272934|BG002|Baseline|Total|Total of all reporting groups
11044209|NCT01272934|FG000|Participant Flow|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
11044210|NCT01272934|FG001|Participant Flow|Placebo|Placebo : Topical gel-4 times daily
11044211|NCT01272934|OG000|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
11044212|NCT01272934|OG001|Outcome|Placebo|Placebo : Topical gel-4 times daily
11044213|NCT01272934|OG001|Outcome|Placebo|
11044214|NCT01272934|EG000|Reported Event|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
11044215|NCT01272934|EG001|Reported Event|Placebo|Placebo : Topical gel-4 times daily
11044216|NCT01272947|BG000|Baseline|Diclofenac Sodium Topical Gel 1%|
11044217|NCT01272947|BG001|Baseline|Placebo|
11044218|NCT01272947|BG002|Baseline|Total|Total of all reporting groups
11044219|NCT01272947|FG000|Participant Flow|Diclofenac Sodium Topical Gel 1%|
11044220|NCT01272947|FG001|Participant Flow|Placebo|
11044221|NCT01272947|OG000|Outcome|Diclofenac Sodium Topical Gel 1%|
11044222|NCT01272947|OG001|Outcome|Placebo|
11044223|NCT01272947|EG000|Reported Event|Diclofenac Sodium Topical Gel 1%|
11044224|NCT01272947|EG001|Reported Event|Placebo|
11044225|NCT01272960|BG000|Baseline|Interval Insertion|14 subjects received Mirena at 4-8 weeks post-partum after vaginal delivery.
11044226|NCT01272960|BG001|Baseline|Post-Placental Mirena Insertion|15 received Mirena insertion within 10 minutes of delivery of placenta
11044227|NCT01272960|BG002|Baseline|Total|Total of all reporting groups
11044228|NCT01272960|FG000|Participant Flow|Interval Insertion|"Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
11044229|NCT01272960|FG001|Participant Flow|Post-Placental Mirena Insertion|"Will receive Mirena insertion within 10 minutes of delivery of placenta~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
11044230|NCT01272960|OG000|Outcome|Post Placental Mirena Insertion|
11044231|NCT01272960|OG001|Outcome|Interval Insertion|
11044232|NCT01272960|OG000|Outcome|Interval Insertion|"Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
11044233|NCT01272960|OG001|Outcome|Post-Placental Mirena Insertion|"Will receive Mirena insertion within 10 minutes of delivery of placenta~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
11044234|NCT01272960|OG000|Outcome|Interval Insertion|"Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.~Interval Insertion: Insertion of Mirena 4-8 weeks post partum after vaginal delivery"
11044235|NCT01272960|EG000|Reported Event|Interval Insertion|
11044236|NCT01272960|EG001|Reported Event|Post Placental Mirena Insertion|
11044237|NCT01272999|BG000|Baseline|MEF Population|Participants with Streptococcus pneumoniae (S pneumoniae) isolates from middle ear fluid (MEF) sample without regard to whether or not they received routinely recommended vaccination of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13) according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule during a surveillance period starting from December 20, 2010 through December 31, 2013.
11044238|NCT01272999|BG001|Baseline|Mastoid Population|Participants with S pneumoniae isolates from mastoid sample without regard to whether or not they received routinely recommended vaccination of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13) according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule during a surveillance period starting from December 20, 2010 through December 31, 2013.
11044239|NCT01272999|BG002|Baseline|Total|Total of all reporting groups
11044240|NCT01272999|FG000|Participant Flow|MEF Population|Participants with Streptococcus pneumoniae (S pneumoniae) isolates from middle ear fluid (MEF) sample without regard to whether or not they received routinely recommended vaccination of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13) according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule during a surveillance period starting from December 20, 2010 through December 31, 2013.
11044241|NCT01272999|FG001|Participant Flow|Mastoid Population|Participants with S pneumoniae isolates from mastoid sample without regard to whether or not they received routinely recommended vaccination of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13) according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule during a surveillance period starting from December 20, 2010 through December 31, 2013.
11044242|NCT01272999|OG000|Outcome|MEF Population|Participants with Streptococcus pneumoniae (S pneumoniae) isolates from middle ear fluid (MEF) sample without regard to whether or not they received routinely recommended vaccination of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13) according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule during a surveillance period starting from December 20, 2010 through December 31, 2013.
11044243|NCT01272999|OG000|Outcome|Mastoid Population|Participants with S pneumoniae isolates from mastoid sample without regard to whether or not they received routinely recommended vaccination of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13) according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule during a surveillance period starting from December 20, 2010 through December 31, 2013.
11044244|NCT01272999|EG000|Reported Event|MEF Population|Participants with Streptococcus pneumoniae (S pneumoniae) isolates from middle ear fluid (MEF) sample without regard to whether or not they received routinely recommended vaccination of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13) according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule during a surveillance period starting from December 20, 2010 through December 31, 2013.
11044245|NCT01272999|EG001|Reported Event|Mastoid Population|Participants with S pneumoniae isolates from mastoid sample without regard to whether or not they received routinely recommended vaccination of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13) according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule during a surveillance period starting from December 20, 2010 through December 31, 2013.
11044246|NCT01273038|BG000|Baseline|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
11044247|NCT01273038|BG001|Baseline|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
11044248|NCT01273038|BG002|Baseline|Total|Total of all reporting groups
11044249|NCT01273038|FG000|Participant Flow|Morfeus First (Test Filter), Then SenSura (Reference Filter)|First Intervention with Morfeus (14 days) then Second Intervention with SenSura (14 days)
11044250|NCT01273038|FG001|Participant Flow|SenSura First (Reference Filter), Then Morfeus (Test Filter)|First Intervention with SenSura (14 days) then Second Intervention with Morfeus (14 days)
11044251|NCT01273038|OG000|Outcome|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
11044252|NCT01273038|OG001|Outcome|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
11044253|NCT01273038|EG000|Reported Event|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
11044254|NCT01273038|EG001|Reported Event|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
11044255|NCT01273155|BG000|Baseline|Normal Function|"Normal Liver Function was defined as bilirubin ≤Upper Limit of Normal (ULN) and aspartate aminotransferase (AST) ≤ ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044256|NCT01273155|BG001|Baseline|Mild Dysfunction|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044257|NCT01273155|BG002|Baseline|Moderate Dysfunction|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044258|NCT01273155|BG003|Baseline|Severe Dysfunction|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044259|NCT01273155|BG004|Baseline|Total|Total of all reporting groups
11044260|NCT01273155|FG000|Participant Flow|Normal Function-Belinostat 1000 mg/m(2)|"Normal Liver Function was defined as bilirubin ≤Upper Limit of Normal (ULN) and aspartate aminotransferase (AST) ≤ ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044261|NCT01273155|FG001|Participant Flow|Mild Dysfunction-Belinostat 750 mg/m(2)|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044262|NCT01273155|FG002|Participant Flow|Mild Dysfunction-Belinostat 1000 mg/m(2)|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044263|NCT01273155|FG003|Participant Flow|Moderate Dysfunction-Belinostat 500 mg/m(2)|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044264|NCT01273155|FG004|Participant Flow|Moderate Dysfunction-Belinostat 750 mg/m(2)|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044265|NCT01273155|FG005|Participant Flow|Severe Dysfunction-Belinostat 250 mg/m(2)|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044266|NCT01273155|FG006|Participant Flow|Severe Dysfunction-Belinostat 350 mg/m(2)|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044267|NCT01273155|OG000|Outcome|Normal Function-Belinostat 1000 mg/m(2)|"Normal Liver Function was defined as bilirubin ≤Upper Limit of Normal (ULN) and aspartate aminotransferase (AST) ≤ ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044268|NCT01273155|OG001|Outcome|Mild Dysfunction-Belinostat 750 mg/m(2)|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044269|NCT01273155|OG002|Outcome|Mild Dysfunction-Belinostat 1000 mg/m(2)|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044270|NCT01273155|OG003|Outcome|Moderate Dysfunction-Belinostat 500 mg/m(2)|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044271|NCT01273155|OG004|Outcome|Moderate Dysfunction-Belinostat 750 mg/m(2)|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044272|NCT01273155|OG005|Outcome|Severe Dysfunction-Belinostat 250 mg/m(2)|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044273|NCT01273155|OG006|Outcome|Severe Dysfunction-Belinostat 350 mg/m(2)|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044274|NCT01273155|OG000|Outcome|Mild Dysfunction|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044275|NCT01273155|OG001|Outcome|Moderate Dysfunction|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044276|NCT01273155|OG002|Outcome|Severe Dysfunction|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044277|NCT01273155|OG000|Outcome|Normal Function|"Normal Liver Function was defined as bilirubin ≤Upper Limit of Normal (ULN) and aspartate aminotransferase (AST) ≤ ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044278|NCT01273155|OG001|Outcome|Mild Dysfunction|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044279|NCT01273155|OG002|Outcome|Moderate Dysfunction|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044280|NCT01273155|OG003|Outcome|Severe Dysfunction|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044281|NCT01273155|EG000|Reported Event|Normal Function-Belinostat 1000 mg/m(2)|"Normal Liver Function was defined as bilirubin ≤Upper Limit of Normal (ULN) and aspartate aminotransferase (AST) ≤ ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044282|NCT01273155|EG001|Reported Event|Mild Dysfunction-Belinostat 750 mg/m(2)|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044283|NCT01273155|EG002|Reported Event|Mild Dysfunction-Belinostat 1000 mg/m(2)|"Mild Liver Dysfunction was defined as bilirubin >Upper Limit of Normal (ULN) but ≤1.5 x ULN and/or aspartate aminotransferase (AST) > ULN.~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044284|NCT01273155|EG003|Reported Event|Moderate Dysfunction-Belinostat 500 mg/m(2)|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044285|NCT01273155|EG004|Reported Event|Moderate Dysfunction-Belinostat 750 mg/m(2)|"Moderate Liver Dysfunction was defined as bilirubin >1.5 to ≤ 3 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044286|NCT01273155|EG005|Reported Event|Severe Dysfunction-Belinostat 250 mg/m(2)|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044287|NCT01273155|EG006|Reported Event|Severe Dysfunction-Belinostat 350 mg/m(2)|"Severe Liver Dysfunction was defined as bilirubin >3 but ≤ 10 x ULN and any aspartate aminotransferase (AST).~Belinostat: Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days)."
11044288|NCT01273181|BG000|Baseline|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044289|NCT01273181|BG001|Baseline|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044290|NCT01273181|BG002|Baseline|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044291|NCT01273181|BG003|Baseline|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044292|NCT01273181|BG004|Baseline|Total|Total of all reporting groups
11044293|NCT01273181|FG000|Participant Flow|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044294|NCT01273181|FG001|Participant Flow|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044295|NCT01273181|FG002|Participant Flow|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC
11044296|NCT01273181|FG003|Participant Flow|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Other cancers
11044297|NCT01273181|OG000|Outcome|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044298|NCT01273181|OG001|Outcome|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044299|NCT01273181|OG002|Outcome|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044300|NCT01273181|OG003|Outcome|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044301|NCT01273181|OG000|Outcome|Anti-MAGE TCR PBL 5x10e9 +HD IL-2|"anti-MAGE A3/12 TCR PBL 3x10e10 to 1 x 10e11 + HD IL-2~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044302|NCT01273181|OG001|Outcome|Anti-MAGE TCR PBL 5x10e10 +HD IL-2|"anti-MAGE A3/12 TCR PBL 5x10e9 to 3 x 10e10 + HD IL-2~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044303|NCT01273181|OG002|Outcome|Anti-MAGE TCR PBL+HD IL-2, Mel, RCC|"anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11341905|NCT03691948|EG000|Reported Event|ROPEs|Responsible Opioid Prescriber Education (ROPES): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources.
11044304|NCT01273181|OG003|Outcome|Anti-MAGE TCR PBL +HD IL-2, Other|"anti-MAGE A3/12 TCR PBL MTD +HD-IL-1 Other cancers~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044305|NCT01273181|EG000|Reported Event|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044306|NCT01273181|EG001|Reported Event|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044307|NCT01273181|EG002|Reported Event|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044308|NCT01273181|EG003|Reported Event|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
11044309|NCT01273207|BG000|Baseline|Inhaled Cyclosporine in HSCT Participants|Hemopoietic Stem Cell transplant (HSCT) subjects with Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) at maximum tolerated dose not exceeding 300 mg administered three times per week
11044310|NCT01273207|FG000|Participant Flow|Inhaled Cyclosporine in HSCT Participants|Hemopoietic Stem Cell transplant (HSCT) subjects with Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) at maximum tolerated dose not exceeding 300 mg administered three times per week
11044311|NCT01273207|OG000|Outcome|Inhaled Cyclosporine in HSCT Participants|Hemopoietic Stem Cell transplant (HSCT) subjects with Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) at maximum tolerated dose not exceeding 300 mg administered three times per week
11044312|NCT01273207|EG000|Reported Event|Inhaled Cyclosporine in HSCT Participants|Hemopoietic Stem Cell transplant (HSCT) subjects with Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) at maximum tolerated dose not exceeding 300 mg administered three times per week
11044313|NCT01273519|BG000|Baseline|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044314|NCT01273519|BG001|Baseline|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044315|NCT01273519|BG002|Baseline|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044316|NCT01273519|BG003|Baseline|Total|Total of all reporting groups
11044317|NCT01273519|FG000|Participant Flow|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044318|NCT01273519|FG001|Participant Flow|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044319|NCT01273519|FG002|Participant Flow|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044320|NCT01273519|OG000|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044321|NCT01273519|OG000|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044322|NCT01273519|OG001|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044323|NCT01273519|OG000|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044324|NCT01273519|OG001|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044325|NCT01273519|OG002|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044326|NCT01273519|OG000|Outcome|PsA, AS|Participants with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044327|NCT01273519|OG000|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044328|NCT01273519|EG000|Reported Event|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
11044329|NCT01273597|BG000|Baseline|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
11044330|NCT01273597|FG000|Participant Flow|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
11044331|NCT01273597|OG000|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
11044332|NCT01273597|EG000|Reported Event|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
11044333|NCT01273623|BG000|Baseline|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
11044334|NCT01273623|FG000|Participant Flow|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
11044335|NCT01273623|OG000|Outcome|Pre-atherectomy|prior to Jetstream use
11044336|NCT01273623|OG001|Outcome|Post-atherectomy|after Jetstream use and prior to adjunctive therapies
11044337|NCT01273623|OG000|Outcome|Study Participants|
11044338|NCT01273623|EG000|Reported Event|Study Participants|
11044339|NCT01273766|BG000|Baseline|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
11044340|NCT01273766|BG001|Baseline|Control Arm|blood tested on healthy patients
11044341|NCT01273766|BG002|Baseline|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
11044342|NCT01273766|BG003|Baseline|Total|Total of all reporting groups
11044343|NCT01273766|FG000|Participant Flow|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
11044344|NCT01273766|FG001|Participant Flow|Control Arm|blood tested on healthy patients
11044345|NCT01273766|FG002|Participant Flow|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
11044346|NCT01273766|OG000|Outcome|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
11044347|NCT01273766|OG001|Outcome|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
11044348|NCT01273766|EG000|Reported Event|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
11044349|NCT01273766|EG001|Reported Event|Control Arm|blood tested on healthy patients
11044350|NCT01273766|EG002|Reported Event|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
11044351|NCT01273805|BG000|Baseline|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11044352|NCT01273805|BG001|Baseline|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11044353|NCT01273805|BG002|Baseline|Total|Total of all reporting groups
11044354|NCT01273805|FG000|Participant Flow|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11044355|NCT01273805|FG001|Participant Flow|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11044356|NCT01273805|OG000|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11044357|NCT01273805|OG001|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11044358|NCT01273805|EG000|Reported Event|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11044359|NCT01273805|EG001|Reported Event|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11044360|NCT01273818|BG000|Baseline|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
11044361|NCT01273818|BG001|Baseline|Cephazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
11044362|NCT01273818|BG002|Baseline|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
11044363|NCT01273818|BG003|Baseline|Total|Total of all reporting groups
11226322|NCT02374060|BG001|Baseline|Intravitreal Triamcinolone 4mg|"(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0~Second injection permitted at Week 8 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection."
11226323|NCT02374060|BG002|Baseline|Dexamethasoneintravitreal Implant|"Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0~Second injection permitted at Week 12 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections."
11226324|NCT02374060|BG003|Baseline|Total|Total of all reporting groups
11341906|NCT03691948|EG001|Reported Event|Control|Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
11044364|NCT01273818|FG000|Participant Flow|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
11044365|NCT01273818|FG001|Participant Flow|Cefazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
11044366|NCT01273818|FG002|Participant Flow|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
11044367|NCT01273818|OG000|Outcome|Topical Gentamicin|Total number of patients to which topical gentamicin was applied for prophylaxis
11044368|NCT01273818|OG001|Outcome|Cefazolin IV|Total number of patients to which ceephazoline (İV) was applied for prophylaxis
11044369|NCT01273818|OG002|Outcome|Topical and iv|Total number of patients to which topical gentamicin and cephazoline (iv) was applied for prophylaxis
11044370|NCT01273818|EG000|Reported Event|Gentamicin|"Gentamicin arm: application of 80 mg gentamycin topically~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
11044371|NCT01273818|EG001|Reported Event|Cephazolin|"Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
11044372|NCT01273818|EG002|Reported Event|Gentamicin+ Cefazolin Sodium|"Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
11044373|NCT01273857|BG000|Baseline|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
11044374|NCT01273857|BG001|Baseline|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
11044375|NCT01273857|BG002|Baseline|Total|Total of all reporting groups
11044376|NCT01273857|FG000|Participant Flow|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
11044377|NCT01273857|FG001|Participant Flow|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
11044378|NCT01273857|OG000|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
11066621|NCT01393444|FG000|Participant Flow|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
11044379|NCT01273857|OG001|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
11044380|NCT01273857|EG000|Reported Event|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
11044381|NCT01273857|EG001|Reported Event|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
11044382|NCT01273883|BG000|Baseline|Entire Study Population|Includes groups randomized to receive magnesium first and placebo first.
11044383|NCT01273883|FG000|Participant Flow|Magnesium First, Then Placebo|Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
11044384|NCT01273883|FG001|Participant Flow|Placebo First, Then Magnesium|Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
11044385|NCT01273883|OG000|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
11044386|NCT01273883|OG001|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
11044387|NCT01273883|EG000|Reported Event|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
11044388|NCT01273883|EG001|Reported Event|Placebo|Placebo administered daily in either first intervention period or second intervention period.
11044389|NCT01273896|BG000|Baseline|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
11226325|NCT02374060|FG000|Participant Flow|Periocular Triamcinolone 40mg|"Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0~Second injection permitted at Week 8 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed."
11341934|NCT03693742|BG001|Baseline|Placebo, Then MSG|"After a fasting period of 4 hours, participants first received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.~Within 1 week, participants returned and after having fasted for 4 hours, then received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan."
11044390|NCT01273896|FG000|Participant Flow|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
11044391|NCT01273896|OG000|Outcome|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
11044392|NCT01273896|EG000|Reported Event|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
11044393|NCT01274182|BG000|Baseline|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044394|NCT01274182|BG001|Baseline|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044395|NCT01274182|BG002|Baseline|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044396|NCT01274182|BG003|Baseline|Total|Total of all reporting groups
11044397|NCT01274182|FG000|Participant Flow|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044398|NCT01274182|FG001|Participant Flow|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044399|NCT01274182|FG002|Participant Flow|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044400|NCT01274182|OG000|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044401|NCT01274182|OG001|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044402|NCT01274182|OG002|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044403|NCT01274182|OG003|Outcome|GP2013 Part I|"This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I.~Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I"
11044404|NCT01274182|OG001|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11341935|NCT03693742|BG002|Baseline|Total|Total of all reporting groups
11044405|NCT01274182|OG002|Outcome|GP2013 Part I|"This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I.~Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I"
11044406|NCT01274182|OG003|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044407|NCT01274182|EG000|Reported Event|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044408|NCT01274182|EG001|Reported Event|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044409|NCT01274182|EG002|Reported Event|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
11044410|NCT01274338|BG000|Baseline|Arm A (HIP)|Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044411|NCT01274338|BG001|Baseline|Arm B (HDI)|Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
11044412|NCT01274338|BG002|Baseline|Arm C (LIP)|Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044413|NCT01274338|BG003|Baseline|Arm D (HIP; Pediatric)|Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (ages 12-17)
11044414|NCT01274338|BG004|Baseline|Arm E (HDI; Pediatric)|Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (ages 12-17)
11044415|NCT01274338|BG005|Baseline|Arm F (LIP; Pediatric)|Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (ages 12-17)
11044416|NCT01274338|BG006|Baseline|Total|Total of all reporting groups
11044417|NCT01274338|FG000|Participant Flow|Arm A (HIP)|Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044418|NCT01274338|FG001|Participant Flow|Arm B (HDI)|Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
11044419|NCT01274338|FG002|Participant Flow|Arm C (LIP)|Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11226834|NCT02378402|OG001|Outcome|Stable HF Group|"Patients with acute HF episode with hospitalization treatment within 12 months, LVEF>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. We quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data."
11044420|NCT01274338|FG003|Participant Flow|Arm D (HIP; Pediatric)|Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (ages 12-17)
11044421|NCT01274338|FG004|Participant Flow|Arm E (HDI; Pediatric)|Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (ages 12-17)
11044422|NCT01274338|FG005|Participant Flow|Arm F (LIP; Pediatric)|Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (ages 12-17)
11044423|NCT01274338|OG000|Outcome|Arm B (HDI)|Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
11044424|NCT01274338|OG001|Outcome|Arm C (LIP)|Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044425|NCT01274338|OG000|Outcome|Arm A (HIP)|Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044426|NCT01274338|OG001|Outcome|Arm B (HDI)|Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
11044427|NCT01274338|OG002|Outcome|Arm C (LIP)|Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044428|NCT01274338|EG000|Reported Event|Arm A (HIP)|Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044429|NCT01274338|EG001|Reported Event|Arm B (HDI)|Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
11044430|NCT01274338|EG002|Reported Event|Arm C (LIP)|Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044431|NCT01274338|EG003|Reported Event|Arm D (HIP; Pediatric)|Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044432|NCT01274338|EG004|Reported Event|Arm E (HDI; Pediatric)|Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
11044433|NCT01274338|EG005|Reported Event|Arm F (LIP; Pediatric)|Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
11044434|NCT01274351|BG000|Baseline|Nilotinib|administered orally at a dose of 300 mg twice daily for 24 months
11044435|NCT01274351|FG000|Participant Flow|Nilotinib|administered orally at a dose of 300 mg twice daily for 24 months
11044436|NCT01274351|OG000|Outcome|Nilotinib|administered orally at a dose of 300 mg twice daily for 24 months
11044437|NCT01274351|EG000|Reported Event|Nilotinib|administered orally at a dose of 300 mg twice daily for 24 months
11044438|NCT01274520|BG000|Baseline|Matched Control Group|This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended criteria donor (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, Model for End-Stage Liver Disease (MELD) score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
11044439|NCT01274520|BG001|Baseline|Experimental: Hypothermic Machine Perfusion Group Group|24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
11044440|NCT01274520|BG002|Baseline|Total|Total of all reporting groups
11044441|NCT01274520|FG000|Participant Flow|Matched Control Group|This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
11044442|NCT01274520|FG001|Participant Flow|Experimental: Medtronic Portable Bypass System Group|24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
11044443|NCT01274520|OG000|Outcome|Matched Control Group|This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
11044444|NCT01274520|OG001|Outcome|Experimental: Hypothermic Machine Perfusion Group|24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
11044445|NCT01274520|OG000|Outcome|Matched Control Group|This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
11044446|NCT01274520|OG000|Outcome|Matched Control Group|This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended criteria donor (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, Model for End-Stage Liver Disease (MELD) score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
11044447|NCT01274520|OG001|Outcome|Experimental: Hypothermic Machine Perfusion Group Group|24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
11044448|NCT01274520|EG000|Reported Event|Matched Control Group|This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
11044449|NCT01274520|EG001|Reported Event|Experimental: Hypothermic Machine Perfusion Group Group|24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
11044450|NCT01274585|BG000|Baseline|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
11044451|NCT01274585|BG001|Baseline|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
11044452|NCT01274585|BG002|Baseline|Total|Total of all reporting groups
11044453|NCT01274585|FG000|Participant Flow|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
11044454|NCT01274585|FG001|Participant Flow|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
11044455|NCT01274585|OG000|Outcome|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
11044456|NCT01274585|OG001|Outcome|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
11044457|NCT01274585|EG000|Reported Event|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
11044458|NCT01274585|EG001|Reported Event|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
11044459|NCT01274637|BG000|Baseline|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
11044460|NCT01274637|BG001|Baseline|Control Group|No treatment control group.
11044461|NCT01274637|BG002|Baseline|Total|Total of all reporting groups
11044462|NCT01274637|FG000|Participant Flow|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
11044463|NCT01274637|FG001|Participant Flow|Control Group|No treatment control group.
11044464|NCT01274637|OG000|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
11044465|NCT01274637|OG001|Outcome|Control Group|No treatment control group.
11044466|NCT01274637|EG000|Reported Event|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
11044467|NCT01274637|EG001|Reported Event|Control Group|No treatment control group.
11044468|NCT01274715|BG000|Baseline|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
11044469|NCT01274715|FG000|Participant Flow|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
11044470|NCT01274715|OG000|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
11044471|NCT01274715|EG000|Reported Event|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
11044472|NCT01274897|BG000|Baseline|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
11044473|NCT01274897|BG001|Baseline|Placebo|Subjects received the saline placebo.
11044474|NCT01274897|BG002|Baseline|Total|Total of all reporting groups
11044475|NCT01274897|FG000|Participant Flow|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
11044476|NCT01274897|FG001|Participant Flow|Placebo|Subjects received the saline placebo.
11044477|NCT01274897|OG000|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
11044478|NCT01274897|OG001|Outcome|Placebo|Subjects received the saline placebo.
11044479|NCT01274897|EG000|Reported Event|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
11044480|NCT01274897|EG001|Reported Event|Placebo|Subjects received the saline placebo.
11044481|NCT01275053|BG000|Baseline|Leptin|leptin: 0.01mg/kg
11044482|NCT01275053|FG000|Participant Flow|Leptin|leptin: 0.01mg/kg
11044483|NCT01275053|OG000|Outcome|Leptin|leptin: 0.01mg/kg
11044484|NCT01275053|EG000|Reported Event|Leptin|leptin: 0.01mg/kg
11044485|NCT01275066|BG000|Baseline|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
11044486|NCT01275066|BG001|Baseline|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
11044487|NCT01275066|BG002|Baseline|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
11044488|NCT01275066|BG003|Baseline|Total|Total of all reporting groups
11044489|NCT01275066|FG000|Participant Flow|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
11044490|NCT01275066|FG001|Participant Flow|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
11044491|NCT01275066|FG002|Participant Flow|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
11044492|NCT01275066|OG000|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
11044493|NCT01275066|OG001|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
11044494|NCT01275066|OG002|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
11044495|NCT01275066|EG000|Reported Event|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
11044496|NCT01275066|EG001|Reported Event|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
11044497|NCT01275066|EG002|Reported Event|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
11044498|NCT01275092|BG000|Baseline|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
11044499|NCT01275092|FG000|Participant Flow|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
11044500|NCT01275092|OG000|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
11044501|NCT01275092|EG000|Reported Event|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
11066622|NCT01393444|OG000|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
11044502|NCT01275131|BG000|Baseline|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
11044503|NCT01275131|BG001|Baseline|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
11044504|NCT01275131|BG002|Baseline|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to a 6-hr euglycemic clamp."
11044505|NCT01275131|BG003|Baseline|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the euglycemic clamp .~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to a 6-hr euglycemic clamp."
11044506|NCT01275131|BG004|Baseline|Total|Total of all reporting groups
11044507|NCT01275131|FG000|Participant Flow|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5-micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
11044508|NCT01275131|FG001|Participant Flow|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
11044509|NCT01275131|FG002|Participant Flow|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp."
11044510|NCT01275131|FG003|Participant Flow|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp .~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp."
11044511|NCT01275131|OG000|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
11044512|NCT01275131|OG001|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
11044513|NCT01275131|OG000|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Day 6 and 8 of Period 2.
11066623|NCT01393444|EG000|Reported Event|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
11044514|NCT01275131|OG001|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
11044515|NCT01275131|OG000|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
11044516|NCT01275131|OG001|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
11044517|NCT01275131|OG000|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
11044518|NCT01275131|OG001|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
11044519|NCT01275131|OG000|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
11044520|NCT01275131|OG001|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days, including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 or Days 6 and 8.
11044521|NCT01275131|OG000|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6 hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
11044522|NCT01275131|OG000|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6 hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
11044523|NCT01275131|EG000|Reported Event|Stage 1: Insulin Aspart|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
11044524|NCT01275131|EG001|Reported Event|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
11044525|NCT01275131|EG002|Reported Event|Stage 3: Insulin Aspart|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3 and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
11044526|NCT01275131|EG003|Reported Event|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
11044527|NCT01275144|BG000|Baseline|Overall|All randomized participants
11044528|NCT01275144|FG000|Participant Flow|LY2216684 + Lorazepam, Then Placebo + Lorazepam|Period 1, 18 milligram (mg) dose of LY2216684 on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3. Period 2, dose of Placebo on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3.
11044529|NCT01275144|FG001|Participant Flow|Placebo + Lorazepam, Then LY2216684 + Lorazepam|Period 1, dose of Placebo on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3.Period 2, 18 milligram (mg) dose of LY2216684 on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3.
11044530|NCT01275144|OG000|Outcome|LY2216684 + Lorazepam|Oral 18 mg dose of LY2216684 on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3
11044531|NCT01275144|OG001|Outcome|Placebo + Lorazepam|Oral dose of Placebo on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3
11044532|NCT01275144|EG000|Reported Event|LY2216684|Oral 18 mg dose of LY2216684 on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3; Serious and Other Adverse Events assessed on Days 1 and 2
11044533|NCT01275144|EG001|Reported Event|Placebo|Oral dose of Placebo on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3; Serious and Other Adverse Events assessed on Days 1 and 2
11044534|NCT01275144|EG002|Reported Event|LY2216684 + Lorazepam|Oral 18 mg dose of LY2216684 on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3; Serious and Other Adverse Events assessed on Days 3-6
11044535|NCT01275144|EG003|Reported Event|Placebo + Lorazepam|Oral dose of Placebo on Days 1-6 with a single oral 1 mg dose of lorazepam on Day 3; Serious and Other Adverse Events assessed on Days 3-6
11044536|NCT01275170|BG000|Baseline|Panel A: Mild Renal Impairment|Participants with an eGFR of >50 to <80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044537|NCT01275170|BG001|Baseline|Panel B: Healthy Controls to Panel A|Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044538|NCT01275170|BG002|Baseline|Panel C: Moderate Renal Impairment|Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044539|NCT01275170|BG003|Baseline|Panel D: Healthy Controls to Panel C|Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044540|NCT01275170|BG004|Baseline|Panel E: Severe Renal Impairment|Participants with an eGFR <30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.
11044541|NCT01275170|BG005|Baseline|Panel F: Healthy Controls to Panel E|A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044542|NCT01275170|BG006|Baseline|Panel G: ESRD/HD Participants|Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2).
11044543|NCT01275170|BG007|Baseline|Panel H: Healthy Controls to Panel G|Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044544|NCT01275170|BG008|Baseline|Total|Total of all reporting groups
11044545|NCT01275170|FG000|Participant Flow|Panel A: Mild Renal Impairment|Participants with an eGFR of >50 to <80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044546|NCT01275170|FG001|Participant Flow|Panel B: Healthy Controls to Panel A|Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044547|NCT01275170|FG002|Participant Flow|Panel C: Moderate Renal Impairment|Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044548|NCT01275170|FG003|Participant Flow|Panel D: Healthy Controls to Panel C|Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044549|NCT01275170|FG004|Participant Flow|Panel E: Severe Renal Impairment|Participants with an eGFR <30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.
11044550|NCT01275170|FG005|Participant Flow|Panel F: Healthy Controls to Panel E|A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044551|NCT01275170|FG006|Participant Flow|Panel G: ESRD/HD Participants|Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2).
11044552|NCT01275170|FG007|Participant Flow|Panel H: Healthy Controls to Panel G|Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044553|NCT01275170|OG000|Outcome|Panel A: Mild Renal Impairment|Participants with an eGFR of >50 to <80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044554|NCT01275170|OG001|Outcome|Panel B: Healthy Controls to Panel A|Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044555|NCT01275170|OG002|Outcome|Panel C: Moderate Renal Impairment|Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044556|NCT01275170|OG003|Outcome|Panel D: Healthy Controls to Panel C|Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044557|NCT01275170|OG004|Outcome|Panel E: Severe Renal Impairment|Participants with an eGFR <30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044558|NCT01275170|OG005|Outcome|Panel F: Healthy Controls to Panel E|A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044559|NCT01275170|OG006|Outcome|Panel G: ESRD/HD Period 1 Postdialysis|Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
11044560|NCT01275170|OG007|Outcome|Panel H: Healthy Controls to Panel G|Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044561|NCT01275170|OG008|Outcome|Panel G: ESRD/HD Period 2 Predialysis|Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
11044562|NCT01275170|OG006|Outcome|Panel H: Healthy Controls to Panel G|Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044563|NCT01275170|OG000|Outcome|Panel E: Severe Renal Impairment|Participants with an eGFR <30 mL/min/1.73m² receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg in Part 2.
11044564|NCT01275170|OG001|Outcome|Panel F: Healthy Controls to Panel E|A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044565|NCT01275170|OG002|Outcome|Panel G: ESRD/HD Period 1 Postdialysis|Participants with ESRD/HD receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg 1 hour predialysis (Period 1) in Part 2.
11044566|NCT01275170|OG003|Outcome|Panel G: ESRD/HD Period 2 Predialysis|Participants with ESRD/HD receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg 24 hours predialysis (Period 2) in Part 2.
11044567|NCT01275170|OG004|Outcome|Panel H: Healthy Controls to Panel G|Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044568|NCT01275170|OG001|Outcome|Panel C: Moderate Renal Impairment|Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044569|NCT01275170|OG002|Outcome|Panel E: Severe Renal Impairment|Participants with an eGFR <30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044570|NCT01275170|OG003|Outcome|Panel G: ESRD/HD Participants|Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Period 1) and predialysis (Period 2) in Part 1.
11044571|NCT01275170|OG004|Outcome|Healthy Matched Controls (Part 1)|Healthy matched controls receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV. Data from all of the Healthy Control subsets from Part 1 was pooled for safety analyses.
11044572|NCT01275170|OG005|Outcome|Panel E: Severe Renal Impairment (Part 2)|Participants with Participants with an eGFR <30 mL/min/1.73m² receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg postdialysis (Period 1) and predialysis (Period 2) in Part 2.
11044573|NCT01275170|OG006|Outcome|Panel G: ESRD/HD (Part 2)|Participants with ESRD/HD receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg postdialysis (Period 1) and predialysis (Period 2) in Part 2.
11044574|NCT01275170|OG007|Outcome|Healthy Matched Controls (Part 2)|Healthy matched controls receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg postdialysis (Period 1) and predialysis (Period 2) in Part 2. Data from all of the Healthy Control subsets from Part 2 was pooled for safety analyses.
11044575|NCT01275170|OG000|Outcome|Panel G: ESRD/HD Period 2 Predialysis|Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
11044576|NCT01275170|EG000|Reported Event|Panel A: Mild Renal Impairment|Participants with an eGFR of >50 to <80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044577|NCT01275170|EG001|Reported Event|Panel C: Moderate Renal Impairment|Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
11044578|NCT01275170|EG002|Reported Event|Panel E: Severe Renal Impairment|Participants with an eGFR <30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.
11044579|NCT01275170|EG003|Reported Event|Panel G: ESRD/HD Participants|Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2).
11044580|NCT01275170|EG004|Reported Event|Healthy Matched Controls|Healthy matched controls receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. For AE reporting, all healthy control participants in Part 1 are pooled into a single arm.
11044581|NCT01275170|EG005|Reported Event|Panel E: Severe Renal Impairment (Part 2)|Participants with an eGFR <30 mL/min/1.73m² receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.
11044582|NCT01275170|EG006|Reported Event|Panel G: ESRD/HC (Part 2)|Participants with ESRD/HD receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.
11044583|NCT01275170|EG007|Reported Event|Healthy Matched Controls (Part 2)|Healthy matched controls receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg in Part 2. For AE reporting, all healthy control participants in Part 2 are pooled into a single arm.
11044584|NCT01275196|BG000|Baseline|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
11044585|NCT01275196|BG001|Baseline|Nilotinib|Patients received 300 mg bid (600 mg/day)
11044586|NCT01275196|BG002|Baseline|Total|Total of all reporting groups
11044587|NCT01275196|FG000|Participant Flow|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
11044588|NCT01275196|FG001|Participant Flow|Nilotinib|Patients received 300 mg bid (600 mg/day)
11044589|NCT01275196|OG000|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
11044590|NCT01275196|OG001|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
11044591|NCT01275196|OG001|Outcome|CGP74588|Major metabolite of Imatinib
11044592|NCT01275196|OG002|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
11044593|NCT01275196|EG000|Reported Event|Imatinib 400 mg qd|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
11044594|NCT01275196|EG001|Reported Event|Nilotinib 300 mg Bid|Patients received 300 mg bid (600 mg/day)
11044595|NCT01275222|BG000|Baseline|Phase l: RAD001 20mg/Week|RAD001 20 mg was given once a week.
11044596|NCT01275222|BG001|Baseline|Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044597|NCT01275222|BG002|Baseline|Phase l: RAD001 5mg/Day + Glivec 600mg/Day|RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044598|NCT01275222|BG003|Baseline|Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
11044599|NCT01275222|BG004|Baseline|Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day|All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044600|NCT01275222|BG005|Baseline|Phase ll: Stratum ll (Post Second-line Therapy)|All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044601|NCT01275222|BG006|Baseline|Total|Total of all reporting groups
11044602|NCT01275222|FG000|Participant Flow|Phase l: RAD001 20mg/Week|RAD001 20 mg was given once a week.
11044603|NCT01275222|FG001|Participant Flow|Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044604|NCT01275222|FG002|Participant Flow|Phase l: RAD001 5mg/Day + Glivec 600mg/Day|RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044605|NCT01275222|FG003|Participant Flow|Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
11044606|NCT01275222|FG004|Participant Flow|Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day|All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044607|NCT01275222|FG005|Participant Flow|Phase ll: Stratum ll (Post Second-line Therapy)|All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044608|NCT01275222|OG000|Outcome|Phase l: RAD001 20mg/Week|RAD001 20 mg was given once a week.
11044609|NCT01275222|OG001|Outcome|Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044610|NCT01275222|OG002|Outcome|Phase l: RAD001 5mg/Day + Glivec 600mg/Day|RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044611|NCT01275222|OG003|Outcome|Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
11044612|NCT01275222|OG004|Outcome|Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day|All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044613|NCT01275222|OG005|Outcome|Phase ll: Stratum ll (Post Second-line Therapy)|All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044614|NCT01275222|OG000|Outcome|Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day|All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044615|NCT01275222|OG001|Outcome|Phase ll: Stratum ll (Post Second-line Therapy)|All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044616|NCT01275222|OG001|Outcome|Phase l: RAD001 5mg/Day + Glivec 600mg/Day|RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044617|NCT01275222|OG002|Outcome|Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044618|NCT01275222|EG000|Reported Event|Phase I - RAD001 20mg/Week ++ Glivec 600mg/Day|RAD001 20 mg was given in combination with Glivec/Gleevec 600mg/day
11044619|NCT01275222|EG001|Reported Event|Phase I: RAD001 2.5mg/Day + Glivec 600mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044620|NCT01275222|EG002|Reported Event|Phase I: RAD001 5mg/Day + Glivec 600mg/Day|RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
11044621|NCT01275222|EG003|Reported Event|Phase I: RAD001 2.5mg/Day + Glivec 800mg/Day|RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
11044622|NCT01275222|EG004|Reported Event|Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day|All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044623|NCT01275222|EG005|Reported Event|Phase ll: Stratum ll (Post Second-line Therapy)|All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
11044624|NCT01275300|BG000|Baseline|All Study Participants|All participants had the same experience of interventions throughout the study, just in different randomized orders of receipt.
11044625|NCT01275300|FG000|Participant Flow|"Placebo+Niacin First, Then Aspirin+Niacin"|"Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days of 81 mg aspirin or placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. The same subjects came back for cross-over study and were assigned to a different group. There was a 2-week washout period between each treatment. Urine was collected sequentially for analysis~Phase II: The same study subjects come back for an open label one week study. They were given 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6. Urine was collected sequentially for analysis"
11044626|NCT01275300|FG001|Participant Flow|Aspirin+Niacin First, Then Placebo+Niacin|"Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days of 81 mg aspirin or placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. The same subjects came back for cross-over study and were assigned to a different group. There was a 2-week washout period between each treatment. Urine was collected sequentially for analysis~Phase II: The same study subjects come back for an open label one week study. They were given 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6. Urine was collected sequentially for analysis"
11044627|NCT01275300|OG000|Outcome|Placebo|
11044628|NCT01275300|OG001|Outcome|Aspirin|
11044629|NCT01275300|EG000|Reported Event|P1: Placebo/Aspirin Followed by Niacin|"Phase 1, 5 days of placebo, followed by a single dose of 600mg niacin on day 6, 10 day washout and 5 days of aspirin 81 mg x followed by a single dose of 600 mg niacin on day 6~P1, placebo/aspirin followed by niacin: 5 days of placebo or aspirin followed by 600 mg niacin, 10 day washout in between two 6-day study periods"
11044630|NCT01275300|EG001|Reported Event|P2: Aspirin and Niacin|"Phase 2, aspirin 81 mg x 5 days and a single dose of 600 mg niacin on day 6~P2, aspirin and niacin: aspirin 81 mg x 5 days and a single dose niacin on day 6"
11044640|NCT01275339|BG000|Baseline|Tadalafil in Diabetic Cohort|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044641|NCT01275339|BG001|Baseline|Placebo in Diabetic Cohort|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
11044642|NCT01275339|BG002|Baseline|Tadalafil in Non-Diabetic Cohort|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044643|NCT01275339|BG003|Baseline|Placebo in Non-Diabetic Cohort|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
11044644|NCT01275339|BG004|Baseline|Total|Total of all reporting groups
11044645|NCT01275339|FG000|Participant Flow|Tadalafil in Diabetic Cohort|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044646|NCT01275339|FG001|Participant Flow|Placebo in Diabetic Cohort|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
11044647|NCT01275339|FG002|Participant Flow|Tadalafil in Non-Diabetic Cohort|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044648|NCT01275339|FG003|Participant Flow|Placebo in Non-Diabetic Cohort|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
11044649|NCT01275339|OG000|Outcome|Tadalafil in Diabetic Cohort|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044650|NCT01275339|OG001|Outcome|Placebo in Diabetic Cohort|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
11044651|NCT01275339|OG002|Outcome|Tadalafil in Non-Diabetic Cohort|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044652|NCT01275339|OG003|Outcome|Placebo in Non-Diabetic Cohort|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
11044653|NCT01275339|EG000|Reported Event|Tadalafil in Diabetic Cohort|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044654|NCT01275339|EG001|Reported Event|Placebo in Diabetic Cohort|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
11226326|NCT02374060|FG001|Participant Flow|Intravitreal Triamcinolone 4mg|"(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0~Second injection permitted at Week 8 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection."
11226327|NCT02374060|FG002|Participant Flow|Dexamethasoneintravitreal Implant|"Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0~Second injection permitted at Week 12 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections."
11226328|NCT02374060|OG000|Outcome|Periocular Triamcinolone 40mg|"Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0~Second injection permitted at Week 8 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed."
11226329|NCT02374060|OG001|Outcome|Intravitreal Triamcinolone 4mg|"(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0~Second injection permitted at Week 8 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection."
11226330|NCT02374060|OG002|Outcome|Dexamethasoneintravitreal Implant|"Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0~Second injection permitted at Week 12 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections."
11226331|NCT02374060|EG000|Reported Event|Periocular Triamcinolone 40mg|"Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0~Second injection permitted at Week 8 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed."
11226332|NCT02374060|EG001|Reported Event|Intravitreal Triamcinolone 4mg|"(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0~Second injection permitted at Week 8 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection."
11066624|NCT01393457|BG000|Baseline|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
11066625|NCT01393457|BG001|Baseline|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
11066626|NCT01393457|BG002|Baseline|Ldopa|levodopa/carbidopa 800/200 mg/d
11066627|NCT01393457|BG003|Baseline|Placebo|Placebo
10887270|NCT00499603|OG000|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
11044655|NCT01275339|EG002|Reported Event|Tadalafil in Non-Diabetic Cohort|Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
11044656|NCT01275339|EG003|Reported Event|Placebo in Non-Diabetic Cohort|Placebo: The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
11044657|NCT01275365|BG000|Baseline|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
11044658|NCT01275365|BG001|Baseline|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
11044659|NCT01275365|BG002|Baseline|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
11044660|NCT01275365|BG003|Baseline|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
11044661|NCT01275365|BG004|Baseline|Total|Total of all reporting groups
11044662|NCT01275365|FG000|Participant Flow|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
11044663|NCT01275365|FG001|Participant Flow|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
11044664|NCT01275365|FG002|Participant Flow|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
11044665|NCT01275365|FG003|Participant Flow|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
11044666|NCT01275365|OG000|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
11044667|NCT01275365|OG001|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
11044668|NCT01275365|OG002|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
11044669|NCT01275365|OG003|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
11044670|NCT01275365|EG000|Reported Event|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
11044671|NCT01275365|EG001|Reported Event|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
11044672|NCT01275365|EG002|Reported Event|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
11044673|NCT01275365|EG003|Reported Event|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
11044674|NCT01275430|BG000|Baseline|Sherlock 3CG|"Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.~Randomization did not occur due to early termination. All participants were assigned to Sherlock 3CG in phase I. Randomization would have occurred at the start of Phase II, but Phase II was not initiated due to early termination."
11044675|NCT01275430|FG000|Participant Flow|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System.~All participants were assigned to Sherlock 3CG in Phase I. Zero subjects started Phase II because of early termination of the study, so zero subjects were randomized. All adverse event reporting is also for Phase I (3CG) participants."
11044676|NCT01275430|OG000|Outcome|Sherlock 3CG|Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
11044677|NCT01275430|OG000|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
11044678|NCT01275430|EG000|Reported Event|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."
11044679|NCT01275586|BG000|Baseline|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
11044680|NCT01275586|FG000|Participant Flow|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
11044681|NCT01275586|OG000|Outcome|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
11044682|NCT01275586|EG000|Reported Event|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
11044683|NCT01275625|BG000|Baseline|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
11044684|NCT01275625|FG000|Participant Flow|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
11044685|NCT01275625|OG000|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
11044686|NCT01275625|EG000|Reported Event|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
11044687|NCT01275664|BG000|Baseline|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
11044688|NCT01275664|FG000|Participant Flow|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
11044689|NCT01275664|OG000|Outcome|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
11044690|NCT01275664|EG000|Reported Event|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
11044691|NCT01275755|BG000|Baseline|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
11044692|NCT01275755|BG001|Baseline|ADL5945 0.25mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
11044693|NCT01275755|BG002|Baseline|Total|Total of all reporting groups
11044694|NCT01275755|FG000|Participant Flow|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
11044695|NCT01275755|FG001|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
11044696|NCT01275755|OG000|Outcome|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
11044697|NCT01275755|OG001|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
11044698|NCT01275755|EG000|Reported Event|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
11044699|NCT01275755|EG001|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
10887313|NCT00499694|BG000|Baseline|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
11044700|NCT01275833|BG000|Baseline|Device Programming Modifies AV Timing|"DDD-40-BiV~Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing"
11044701|NCT01275833|BG001|Baseline|Device Programming Allows Intrinsic AV Timing.|VVI-40-RV
11044702|NCT01275833|BG002|Baseline|Total|Total of all reporting groups
11044703|NCT01275833|FG000|Participant Flow|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
11044704|NCT01275833|FG001|Participant Flow|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
11044705|NCT01275833|OG000|Outcome|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
11044706|NCT01275833|OG001|Outcome|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
11044707|NCT01275833|EG000|Reported Event|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
11226333|NCT02374060|EG002|Reported Event|Dexamethasoneintravitreal Implant|"Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0~Second injection permitted at Week 12 IF:~Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;~IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;~Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections."
11226334|NCT02374099|BG000|Baseline|CC-486 and Fulvestrant|Participants received CC-486 tablets by mouth (PO) daily (QD) on days 1-21 of each 28 day treatment cycle and fulvestrant 500 mg by intramuscular injection (IM) on days 1 and 15 of cycle 1 and on day 1 only in subsequent cycles until disease progression, start of new anticancer therapy, death, withdrawal of consent, or lost to follow-up withdrawal of consent, or lost to follow-up.
11044708|NCT01275833|EG001|Reported Event|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
11044709|NCT01276041|BG000|Baseline|Pertuzumab in Combination With Trastuzumab and Paclitaxel|This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
11044710|NCT01276041|FG000|Participant Flow|Pertuzumab in Combination With Trastuzumab and Paclitaxel|This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
11044711|NCT01276041|OG000|Outcome|Pertuzumab in Combination With Trastuzumab and Paclitaxel|This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
11044712|NCT01276041|EG000|Reported Event|Pertuzumab in Combination With Trastuzumab and Paclitaxel|This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
11044713|NCT01276106|BG000|Baseline|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
11044714|NCT01276106|BG001|Baseline|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
11044715|NCT01276106|BG002|Baseline|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
11226335|NCT02374099|BG001|Baseline|Fulvestrant|Participants received fulvestrant 500 mg by intramuscular injection on days 1 and 15 of cycle 1 and on day 1 only in subsequent cycles until disease progression, start of new anticancer therapy, death, withdrawal of consent, or lost to follow-up.
11044716|NCT01276106|BG003|Baseline|Placebo|Placebo: Capsule, BID
11044717|NCT01276106|BG004|Baseline|Total|Total of all reporting groups
11044718|NCT01276106|FG000|Participant Flow|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
11226336|NCT02374099|BG002|Baseline|Total|Total of all reporting groups
11044719|NCT01276106|FG001|Participant Flow|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
11044720|NCT01276106|FG002|Participant Flow|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
11044721|NCT01276106|FG003|Participant Flow|Placebo|Placebo: Capsule, BID
11044722|NCT01276106|OG000|Outcome|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
11044723|NCT01276106|OG001|Outcome|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
11044724|NCT01276106|OG002|Outcome|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
11044725|NCT01276106|OG003|Outcome|Placebo|Placebo: Capsule, BID
11044726|NCT01276106|EG000|Reported Event|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
11044727|NCT01276106|EG001|Reported Event|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
11044728|NCT01276106|EG002|Reported Event|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
11044729|NCT01276106|EG003|Reported Event|Placebo|Placebo: Capsule, BID
11044730|NCT01276171|BG000|Baseline|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
11044731|NCT01276171|BG001|Baseline|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
11044732|NCT01276171|BG002|Baseline|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
11044733|NCT01276171|BG003|Baseline|Total|Total of all reporting groups
11044734|NCT01276171|FG000|Participant Flow|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
11044735|NCT01276171|FG001|Participant Flow|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
11044736|NCT01276171|FG002|Participant Flow|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
11044737|NCT01276171|OG000|Outcome|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
11044738|NCT01276171|OG001|Outcome|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
11044739|NCT01276171|OG002|Outcome|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
11044740|NCT01276171|EG000|Reported Event|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
11044741|NCT01276171|EG001|Reported Event|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
11044742|NCT01276171|EG002|Reported Event|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
11044743|NCT01276184|BG000|Baseline|Usual Care|Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate).
11044744|NCT01276184|BG001|Baseline|SMS Text Message|"Participants in both Usual Care group and the Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s). Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit.~SMS Text Message: Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s) (phone call, letter, etc, as appropriate)."
11044745|NCT01276184|BG002|Baseline|Total|Total of all reporting groups
11044746|NCT01276184|FG000|Participant Flow|Usual Care|Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate).
11044747|NCT01276184|FG001|Participant Flow|SMS Text Message|"Participants in both Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit.~SMS Text Message: Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s) (phone call,"
11044748|NCT01276184|OG000|Outcome|Usual Care|Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate).
11044749|NCT01276184|OG001|Outcome|SMS Text Message|"Participants in both Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit.~SMS Text Message: Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s) (phone call,"
11044750|NCT01276184|EG000|Reported Event|Usual Care|Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate).
11044751|NCT01276184|EG001|Reported Event|SMS Text Message|"Participants in both Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit.~SMS Text Message: Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s)."
11044752|NCT01276197|BG000|Baseline|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
11044753|NCT01276197|BG001|Baseline|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
11044754|NCT01276197|BG002|Baseline|Total|Total of all reporting groups
11044755|NCT01276197|FG000|Participant Flow|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
11044756|NCT01276197|FG001|Participant Flow|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
11044757|NCT01276197|OG000|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
11044758|NCT01276197|OG001|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
11066628|NCT01393457|BG004|Baseline|Total|Total of all reporting groups
11044759|NCT01276197|EG000|Reported Event|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
11044760|NCT01276197|EG001|Reported Event|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
11044761|NCT01276223|BG000|Baseline|Run-In Only|Difluprednate vehicle
11044762|NCT01276223|BG001|Baseline|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
11044763|NCT01276223|BG002|Baseline|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
11044764|NCT01276223|BG003|Baseline|Total|Total of all reporting groups
11044765|NCT01276223|FG000|Participant Flow|Run-In Only|Difluprednate vehicle
11044766|NCT01276223|FG001|Participant Flow|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
11044767|NCT01276223|FG002|Participant Flow|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
11044768|NCT01276223|OG000|Outcome|Durezol|Difluprednate 0.5% ophthalmic emulsion
11044769|NCT01276223|OG001|Outcome|Vehicle|Difluprednate vehicle
11044770|NCT01276223|EG000|Reported Event|Run-In|Difluprednate vehicle, all patients
11044771|NCT01276223|EG001|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion
11044772|NCT01276223|EG002|Reported Event|Vehicle|Difluprednate vehicle
11044773|NCT01276236|BG000|Baseline|Treatment Arm (Maraviroc)|"The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.~Maraviroc: FDA Recommended dosing will be used in this study. Subjects on an efavirenz or etravirine-based regimen will be dosed at 600 mg orally, twice per day, for 96 weeks.~Subjects on a ritonavir-boosted protease inhibitor based regimen (except for tipranavir/ritonavir) will be dosed at 150 mg orally, twice per day, for 96 weeks.~Subjects that are on regimens that do not include etravirine, efavirenz, or ritonavir will be dosed at 300mg orally, twice per day, for 96 weeks. These doses are based on the recommendations from the company based on drug-drug interactions."
11226337|NCT02374099|FG000|Participant Flow|CC-486 and Fulvestrant|Participants received CC-486 tablets by mouth (PO) daily (QD) on days 1-21 of each 28 day treatment cycle and fulvestrant 500 mg by intramuscular injection (IM) on days 1 and 15 of cycle 1 and on day 1 only in subsequent cycles until disease progression, start of new anticancer therapy, death, withdrawal of consent, or lost to follow-up withdrawal of consent, or lost to follow-up.
11226338|NCT02374099|FG001|Participant Flow|Fulvestrant|Participants received fulvestrant 500 mg by intramuscular injection on days 1 and 15 of cycle 1 and on day 1 only in subsequent cycles until disease progression, start of new anticancer therapy, death, withdrawal of consent, or lost to follow-up.
11226339|NCT02374099|OG000|Outcome|CC-486 and Fulvestrant|Participants received CC-486 tablets by mouth (PO) daily (QD) on days 1-21 of each 28 day treatment cycle and fulvestrant 500 mg by intramuscular injection (IM) on days 1 and 15 of cycle 1 and on day 1 only in subsequent cycles until disease progression, start of new anticancer therapy, death, withdrawal of consent, or lost to follow-up withdrawal of consent, or lost to follow-up.
11044774|NCT01276236|FG000|Participant Flow|Treatment Arm (Maraviroc)|"The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.~Maraviroc: FDA Recommended dosing will be used in this study. Subjects on an efavirenz or etravirine-based regimen will be dosed at 600 mg orally, twice per day, for 96 weeks.~Subjects on a ritonavir-boosted protease inhibitor based regimen (except for tipranavir/ritonavir) will be dosed at 150 mg orally, twice per day, for 96 weeks.~Subjects that are on regimens that do not include etravirine, efavirenz, or ritonavir will be dosed at 300mg orally, twice per day, for 96 weeks. These doses are based on the recommendations from the company based on drug-drug interactions."
11044775|NCT01276236|OG000|Outcome|Treatment Arm (Maraviroc)|"The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.~Maraviroc: FDA Recommended dosing will be used in this study. Subjects on an efavirenz or etravirine-based regimen will be dosed at 600 mg orally, twice per day, for 96 weeks.~Subjects on a ritonavir-boosted protease inhibitor based regimen (except for tipranavir/ritonavir) will be dosed at 150 mg orally, twice per day, for 96 weeks.~Subjects that are on regimens that do not include etravirine, efavirenz, or ritonavir will be dosed at 300mg orally, twice per day, for 96 weeks. These doses are based on the recommendations from the company based on drug-drug interactions."
11044776|NCT01276236|EG000|Reported Event|Treatment Arm (Maraviroc)|"The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.~Maraviroc: FDA Recommended dosing will be used in this study. Subjects on an efavirenz or etravirine-based regimen will be dosed at 600 mg orally, twice per day, for 96 weeks.~Subjects on a ritonavir-boosted protease inhibitor based regimen (except for tipranavir/ritonavir) will be dosed at 150 mg orally, twice per day, for 96 weeks.~Subjects that are on regimens that do not include etravirine, efavirenz, or ritonavir will be dosed at 300mg orally, twice per day, for 96 weeks. These doses are based on the recommendations from the company based on drug-drug interactions."
11044777|NCT01276288|BG000|Baseline|Overall Patients|A randomised, open-label, multiple-dose, 2- way cross-over study. All patients received 25 mg empagliflozin in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h) (days 1 to 5). Following a wash-out period of seven days, half of the patients received 25 mg hydrochlorothiazide (HCT) either on its own in a form of a film-coated tablet orally once daily (days 1 to 4) or in combination with 25 mg empagliflozin ( days 5 to 9), while the other half of the patients received 5 mg torasemide (TOR) either on its own (days 1 to 4) or in combination with the 25 mg empagliflozin ( days 5 to 9). This sequence was then reversed so that the HCT or TOR and its combination with 25 mg empagliflozin were administered first in a same manner as stated above, followed by 25 mg empagliflozin after seven days wash out period.
11044778|NCT01276288|FG000|Participant Flow|Empa / Empa+HCT|Patients received 25mg empagliflozin (Empa) orally in a form of a film-coated tablet once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet was administered orally once daily in combination with 25mg Empa.
11066629|NCT01393457|FG000|Participant Flow|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
11044779|NCT01276288|FG001|Participant Flow|Empa+HCT/ Empa|Patients received 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet orally once daily in combination with 25mg Empa. Following a wash-out period of seven days 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
11044780|NCT01276288|FG002|Participant Flow|Empa/ Empa+ TOR|Patients received 25mg Empa in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 5 mg torasemide (TOR) in combination with 25mg Empa was administered.
11044781|NCT01276288|FG003|Participant Flow|Empa+TOR/ Empa|Patients received 5mg torasemide (TOR) in combination with 25mg Empa. Following a wash-out period of seven days, 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
11044782|NCT01276288|OG000|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
11044783|NCT01276288|OG001|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
11044784|NCT01276288|OG002|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
11044785|NCT01276288|OG003|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
11044786|NCT01276288|OG004|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
11044787|NCT01276288|OG001|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
11044788|NCT01276288|OG002|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
11044789|NCT01276288|OG000|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
11044790|NCT01276288|OG001|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
11044791|NCT01276288|OG000|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
11044792|NCT01276288|OG001|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
11044793|NCT01276288|OG002|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
11044794|NCT01276288|OG003|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
11044795|NCT01276288|OG004|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
11044796|NCT01276288|OG005|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
11044797|NCT01276288|EG000|Reported Event|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
11044798|NCT01276288|EG001|Reported Event|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
11044799|NCT01276288|EG002|Reported Event|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
11044800|NCT01276288|EG003|Reported Event|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
11044801|NCT01276288|EG004|Reported Event|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
11044802|NCT01276301|BG000|Baseline|Entire Study Population|"An open label, randomised, two-period crossover trial. The two treatments administered were~A single dose of empagliflozin (empa) 25 mg~A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil~The two treatment periods were separated by a washout period of at least 7 days."
11044803|NCT01276301|FG000|Participant Flow|Empa / Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
11044804|NCT01276301|FG001|Participant Flow|Empa Plus Verapamil / Empa|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg.
11044805|NCT01276301|OG000|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
11044806|NCT01276301|OG001|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
11044807|NCT01276301|OG000|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
11044808|NCT01276301|EG000|Reported Event|Empa|A single dose of empagliflozin (empa) 25 mg.
11044809|NCT01276301|EG001|Reported Event|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
11044810|NCT01276314|BG000|Baseline|Anti- TNF-a Treatment (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
11044811|NCT01276314|BG001|Baseline|Control Group (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
11044812|NCT01276314|BG002|Baseline|Anti- TNF-a Treatment (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
11044813|NCT01276314|BG003|Baseline|Control Group (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
11044814|NCT01276314|BG004|Baseline|Total|Total of all reporting groups
11044815|NCT01276314|FG000|Participant Flow|Anti- TNF-a Treatment (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
11044816|NCT01276314|FG001|Participant Flow|Control Group (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
11044817|NCT01276314|FG002|Participant Flow|Anti- TNF-a Treatment (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
11044818|NCT01276314|FG003|Participant Flow|Control Group (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
11044819|NCT01276314|OG000|Outcome|Anti- TNF-a Treatment (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
11044820|NCT01276314|OG001|Outcome|Control Group (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
11044821|NCT01276314|OG002|Outcome|Anti- TNF-a Treatment (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
11044822|NCT01276314|OG003|Outcome|Control Group (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
11044823|NCT01276314|EG000|Reported Event|Anti- TNF-a Treatment (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
11044824|NCT01276314|EG001|Reported Event|Control Group (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
11044825|NCT01276314|EG002|Reported Event|Anti- TNF-a Treatment (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
11044826|NCT01276314|EG003|Reported Event|Control Group (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
11044827|NCT01276327|BG000|Baseline|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
11044828|NCT01276327|BG001|Baseline|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
11044829|NCT01276327|BG002|Baseline|Total|Total of all reporting groups
11044830|NCT01276327|FG000|Participant Flow|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
11044831|NCT01276327|FG001|Participant Flow|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
11044832|NCT01276327|OG000|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
11044833|NCT01276327|OG001|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
11044834|NCT01276327|EG000|Reported Event|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
11044835|NCT01276327|EG001|Reported Event|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
11044836|NCT01276353|BG000|Baseline|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044837|NCT01276353|BG001|Baseline|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044838|NCT01276353|BG002|Baseline|Total|Total of all reporting groups
11044839|NCT01276353|FG000|Participant Flow|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044840|NCT01276353|FG001|Participant Flow|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044841|NCT01276353|OG000|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044842|NCT01276353|OG001|Outcome|E2020 10 mg (EM)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044843|NCT01276353|OG000|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once in the morning daily for 52 weeks in the extension phase.
11044844|NCT01276353|OG001|Outcome|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044845|NCT01276353|EG000|Reported Event|E2020 SR 23 mg (Double-blind)|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
11044846|NCT01276353|EG001|Reported Event|E2020 10 mg (Double-blind)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
11044847|NCT01276353|EG002|Reported Event|E2020 SR 23 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044848|NCT01276353|EG003|Reported Event|E2020 10 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
11044849|NCT01276379|BG000|Baseline|WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab|"Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.~FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.~FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~Cetuximab: - 500 mg/m2 i.v. Every 2 weeks."
11044850|NCT01276379|BG001|Baseline|Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab|"Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.~FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.~FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~Cetuximab: - 500 mg/m2 i.v. Every 2 weeks."
11226340|NCT02374099|OG001|Outcome|Fulvestrant|Participants received fulvestrant 500 mg by intramuscular injection on days 1 and 15 of cycle 1 and on day 1 only in subsequent cycles until disease progression, start of new anticancer therapy, death, withdrawal of consent, or lost to follow-up.
11044851|NCT01276379|BG002|Baseline|Total|Total of all reporting groups
11044852|NCT01276379|FG000|Participant Flow|FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab|"FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.~FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~Cetuximab: - 500 mg/m2 i.v. Every 2 weeks."
11044853|NCT01276379|OG000|Outcome|WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab|"Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.~FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.~FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~Cetuximab: - 500 mg/m2 i.v. Every 2 weeks."
11044854|NCT01276379|OG001|Outcome|Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab|"Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.~FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.~FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~Cetuximab: - 500 mg/m2 i.v. Every 2 weeks."
11044855|NCT01276379|OG000|Outcome|FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab|"FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.~FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~Cetuximab: - 500 mg/m2 i.v. Every 2 weeks."
11044856|NCT01276379|EG000|Reported Event|FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab|"FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.~FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:~Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.~Cetuximab: - 500 mg/m2 i.v. Every 2 weeks."
11044857|NCT01276457|BG000|Baseline|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
11066630|NCT01393457|FG001|Participant Flow|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
11226341|NCT02374099|EG000|Reported Event|CC-486 and Fulvestrant|Participants received CC-486 tablets by mouth (PO) daily (QD) on days 1-21 of each 28 day treatment cycle and fulvestrant 500 mg by intramuscular injection (IM) on days 1 and 15 of cycle 1 and on day 1 only in subsequent cycles until disease progression, start of new anticancer therapy, death, withdrawal of consent, or lost to follow-up withdrawal of consent, or lost to follow-up.
11066631|NCT01393457|FG002|Participant Flow|Ldopa|levodopa/carbidopa 800/200 mg/d
11066632|NCT01393457|FG003|Participant Flow|Placebo|Placebo
11066633|NCT01393457|OG000|Outcome|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
11044858|NCT01276457|BG001|Baseline|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
11044859|NCT01276457|BG002|Baseline|Total|Total of all reporting groups
11044860|NCT01276457|FG000|Participant Flow|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
11044861|NCT01276457|FG001|Participant Flow|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
11044862|NCT01276457|OG000|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
11044863|NCT01276457|OG001|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
11044864|NCT01276457|EG000|Reported Event|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
11044865|NCT01276457|EG001|Reported Event|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
11044866|NCT01276509|BG000|Baseline|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
11044867|NCT01276509|BG001|Baseline|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
11044868|NCT01276509|BG002|Baseline|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
11044869|NCT01276509|BG003|Baseline|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
11044870|NCT01276509|BG004|Baseline|Total|Total of all reporting groups
11044871|NCT01276509|FG000|Participant Flow|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
11044872|NCT01276509|FG001|Participant Flow|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
11044873|NCT01276509|FG002|Participant Flow|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
11044874|NCT01276509|FG003|Participant Flow|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
11044875|NCT01276509|OG000|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
11044876|NCT01276509|OG001|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
11044877|NCT01276509|OG002|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
11044878|NCT01276509|OG003|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
11044879|NCT01276509|EG000|Reported Event|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
11044880|NCT01276509|EG001|Reported Event|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
11044881|NCT01276509|EG002|Reported Event|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
11044882|NCT01276509|EG003|Reported Event|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
11044883|NCT01276535|BG000|Baseline|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
11066634|NCT01393457|OG001|Outcome|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
11066635|NCT01393457|OG002|Outcome|Ldopa|levodopa/carbidopa 800/200 mg/d
11066636|NCT01393457|OG003|Outcome|Placebo|Placebo
11044884|NCT01276535|FG000|Participant Flow|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
11044885|NCT01276535|OG000|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
11044886|NCT01276535|EG000|Reported Event|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
11044887|NCT01276639|BG000|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
11044888|NCT01276639|BG001|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11044889|NCT01276639|BG002|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
11044890|NCT01276639|BG003|Baseline|Total|Total of all reporting groups
11044891|NCT01276639|FG000|Participant Flow|CP-690,550 5 mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
11044892|NCT01276639|FG001|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11044893|NCT01276639|FG002|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
11044894|NCT01276639|FG003|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11044895|NCT01276639|FG004|Participant Flow|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11044896|NCT01276639|OG000|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
11044897|NCT01276639|OG001|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11044898|NCT01276639|OG002|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
11044899|NCT01276639|OG000|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11044900|NCT01276639|OG001|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11044901|NCT01276639|OG002|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11044902|NCT01276639|OG003|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11044903|NCT01276639|OG003|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11044904|NCT01276639|EG000|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
11044905|NCT01276639|EG001|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11044906|NCT01276639|EG002|Reported Event|Placebo, CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
11044907|NCT01276639|EG003|Reported Event|Placebo, CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
11044908|NCT01276639|EG004|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
11044909|NCT01276652|BG000|Baseline|Environmental Modification|Subjects received an environmental modification intervention designed to strengthen day/night routines for the first 48 hours beginning the morning after enrollment. Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
11044910|NCT01276652|BG001|Baseline|Usual Care (Randomized)|Usual Care was provided for the first 48 hours.
11044911|NCT01276652|BG002|Baseline|Usual Care (Observational)|Usual care was provided for the first 48 hours.
11044912|NCT01276652|BG003|Baseline|Total|Total of all reporting groups
11044913|NCT01276652|FG000|Participant Flow|Randomization: Environmental Modification Group|Subjects randomized to this group underwent the environmental modification intervention designed to promote strong day/night routines for 48 hours.
11044914|NCT01276652|FG001|Participant Flow|Randomization: Usual Care|Subjects received usual care for 48 hours beginning the morning after enrollment. A subset of this group received the intervention on a pilot basis after this time period had elapsed.
11044915|NCT01276652|FG002|Participant Flow|Usual Care (Observational)|Subjects received usual care for 48 hours beginning the morning after enrollment.
11044916|NCT01276652|OG000|Outcome|Environmental Modification|A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
11044917|NCT01276652|OG001|Outcome|Usual Care (Randomized)|Usual Care was provided during the first 48 hours.
11044918|NCT01276652|OG002|Outcome|Usual Care (Observational)|Usual care was provided for 48 hours.
11044919|NCT01276652|OG000|Outcome|Environmental Modification|"In a subset of this study, subjects are randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). Usual Care was provided outside of this interval.~Environmental modification: Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night."
11044920|NCT01276652|OG001|Outcome|Usual Care (Randomized)|Usual care for 48 hours.
11044921|NCT01276652|OG002|Outcome|Usual Care (Observational)|Usual care is provided to the subjects for 48 hours.
11044922|NCT01276652|OG001|Outcome|Usual Care (Randomized)|Usual Care was provided to the subjects.
11044923|NCT01276652|OG002|Outcome|Usual Care (Observational)|Usual care was provided to the subjects.
11044924|NCT01276652|EG000|Reported Event|Environmental Modification|Environmental modification is provided for the initial 48 hours and consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
11226342|NCT02374099|EG001|Reported Event|Fulvestrant|Participants received fulvestrant 500 mg by intramuscular injection on days 1 and 15 of cycle 1 and on day 1 only in subsequent cycles until disease progression, start of new anticancer therapy, death, withdrawal of consent, or lost to follow-up.
11044925|NCT01276652|EG001|Reported Event|Usual Care (Randomized)|Usual care is provided to the subjects.
11044926|NCT01276652|EG002|Reported Event|Usual Care (Observational)|Usual care is provided to the subjects.
11044927|NCT01276756|BG000|Baseline|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
11044928|NCT01276756|BG001|Baseline|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
11044929|NCT01276756|BG002|Baseline|Total|Total of all reporting groups
11044930|NCT01276756|FG000|Participant Flow|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
11044931|NCT01276756|FG001|Participant Flow|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
11044932|NCT01276756|OG000|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
11044933|NCT01276756|OG001|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
11044934|NCT01276756|EG000|Reported Event|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
11044935|NCT01276756|EG001|Reported Event|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
11044936|NCT01276821|BG000|Baseline|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
11226343|NCT02374138|BG000|Baseline|Usual Care|"IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination~Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination"
11044937|NCT01276821|BG001|Baseline|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
11044938|NCT01276821|BG002|Baseline|Total|Total of all reporting groups
11044939|NCT01276821|FG000|Participant Flow|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
11044940|NCT01276821|FG001|Participant Flow|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
11044941|NCT01276821|OG000|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
11044942|NCT01276821|OG001|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
11044943|NCT01276821|EG000|Reported Event|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
11044944|NCT01276821|EG001|Reported Event|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
11044945|NCT01276847|BG000|Baseline|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
11044946|NCT01276847|BG001|Baseline|No Treatment|No treatment administered
11066637|NCT01393457|EG000|Reported Event|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
11044947|NCT01276847|BG002|Baseline|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
11044948|NCT01276847|BG003|Baseline|Total|Total of all reporting groups
11044949|NCT01276847|FG000|Participant Flow|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
11044950|NCT01276847|FG001|Participant Flow|No Treatment|No treatment administered
11044951|NCT01276847|FG002|Participant Flow|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
11044952|NCT01276847|OG000|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
11044953|NCT01276847|OG000|Outcome|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
11044954|NCT01276847|EG000|Reported Event|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
11044955|NCT01276847|EG001|Reported Event|No Treatment|No treatment administered
11044956|NCT01276847|EG002|Reported Event|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
11044957|NCT01276860|BG000|Baseline|Treatment Group|PVT subjects with sleep complaints.Control subjects will be asked to participate in one session. Treatment subjects will be asked to participate in 3 sessions.
11044958|NCT01276860|BG001|Baseline|Control Group|PVT subjects without sleep complaints.Control subjects will be asked to participate in one session. Treatment subjects will be asked to participate in 3 sessions.
11044959|NCT01276860|BG002|Baseline|Total|Total of all reporting groups
11044960|NCT01276860|FG000|Participant Flow|Treatment Group|PVT subjects with sleep complaints.
11044961|NCT01276860|FG001|Participant Flow|Control Group|PVT subjects without sleep complaints.
11044962|NCT01276860|OG000|Outcome|Treatment Group|PVT subjects with sleep complaints/Obstructive Sleep Apnea.
11044963|NCT01276860|OG001|Outcome|Control Group|PVT subjects without sleep complaints.
11044964|NCT01276860|EG000|Reported Event|Treatment Group|PVT subjects with sleep complaints.
11044965|NCT01276860|EG001|Reported Event|Control Group|PVT subjects without sleep complaints.
11044966|NCT01277042|BG000|Baseline|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044967|NCT01277042|BG001|Baseline|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044968|NCT01277042|BG002|Baseline|Total|Total of all reporting groups
11044969|NCT01277042|FG000|Participant Flow|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044970|NCT01277042|FG001|Participant Flow|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044971|NCT01277042|OG000|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044972|NCT01277042|OG001|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044973|NCT01277042|OG001|Outcome|Engerix-B Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044974|NCT01277042|EG000|Reported Event|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044975|NCT01277042|EG001|Reported Event|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11044976|NCT01277081|BG000|Baseline|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
11044977|NCT01277081|BG001|Baseline|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
11044978|NCT01277081|BG002|Baseline|Total|Total of all reporting groups
11044979|NCT01277081|FG000|Participant Flow|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 milligram (mg) of paracetamol in 200 milliliter (mL) of boiled mineral water was taken orally by participants within a time period of 15 minutes.
11044980|NCT01277081|FG001|Participant Flow|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
11044981|NCT01277081|OG000|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
11044982|NCT01277081|OG001|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
11044983|NCT01277081|EG000|Reported Event|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
11044984|NCT01277081|EG001|Reported Event|Paracetamol Tablets|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
11044985|NCT01277159|BG000|Baseline|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).~A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
11044986|NCT01277159|BG001|Baseline|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.~B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
11044987|NCT01277159|BG002|Baseline|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)~C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
11044988|NCT01277159|BG003|Baseline|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).~D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
11044989|NCT01277159|BG004|Baseline|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.~E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).~IV saline."
11044990|NCT01277159|BG005|Baseline|Total|Total of all reporting groups
11044991|NCT01277159|FG000|Participant Flow|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).~A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
11044992|NCT01277159|FG001|Participant Flow|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.~B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
11044993|NCT01277159|FG002|Participant Flow|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)~C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
11044994|NCT01277159|FG003|Participant Flow|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).~D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
11044995|NCT01277159|FG004|Participant Flow|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.~E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).~IV saline."
11044996|NCT01277159|OG000|Outcome|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).~A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
11044997|NCT01277159|OG001|Outcome|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.~B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
11044998|NCT01277159|OG002|Outcome|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)~C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
11044999|NCT01277159|OG003|Outcome|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).~D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
11045000|NCT01277159|OG004|Outcome|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.~E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).~IV saline."
11045001|NCT01277159|EG000|Reported Event|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).~A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
11045002|NCT01277159|EG001|Reported Event|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.~B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
11045003|NCT01277159|EG002|Reported Event|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)~C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
11045004|NCT01277159|EG003|Reported Event|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).~D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
11045005|NCT01277159|EG004|Reported Event|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.~E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).~IV saline."
11045006|NCT01277302|BG000|Baseline|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
11045007|NCT01277302|BG001|Baseline|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
11045008|NCT01277302|BG002|Baseline|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
11045009|NCT01277302|BG003|Baseline|Total|Total of all reporting groups
11045010|NCT01277302|FG000|Participant Flow|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
11045011|NCT01277302|FG001|Participant Flow|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
11045012|NCT01277302|FG002|Participant Flow|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
11045013|NCT01277302|OG000|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
11045014|NCT01277302|OG001|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
11045015|NCT01277302|OG002|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
11045016|NCT01277302|EG000|Reported Event|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
11045017|NCT01277302|EG001|Reported Event|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
11045018|NCT01277302|EG002|Reported Event|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
11045019|NCT01277341|BG000|Baseline|2% Twice a Day|"Bepotastine Besilate Nasal Spray 2% Twice a day~Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray"
11045020|NCT01277341|BG001|Baseline|3% Twice a Day|"Bepotastine Besilate Nasal Spray 3% Twice a day~Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray"
11045021|NCT01277341|BG002|Baseline|4% Twice a Day|"Bepotastine Besilate Nasal Spray 4% Twice a day~Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray"
11045022|NCT01277341|BG003|Baseline|Placebo|"Placebo nasal spray~Placebo Nasal Spray: nasal spray"
11045023|NCT01277341|BG004|Baseline|Total|Total of all reporting groups
11045024|NCT01277341|FG000|Participant Flow|2% Twice a Day|"Bepotastine Besilate Nasal Spray 2% Twice a day~Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray"
11045025|NCT01277341|FG001|Participant Flow|3% Twice a Day|"Bepotastine Besilate Nasal Spray 3% Twice a day~Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray"
11045026|NCT01277341|FG002|Participant Flow|4% Twice a Day|"Bepotastine Besilate Nasal Spray 4% Twice a day~Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray"
11045027|NCT01277341|FG003|Participant Flow|Placebo|"Placebo nasal spray~Placebo Nasal Spray: nasal spray"
11045028|NCT01277341|OG000|Outcome|2% Twice a Day|"Bepotastine Besilate Nasal Spray 2% Twice a day~Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray"
11045029|NCT01277341|OG001|Outcome|3% Twice a Day|"Bepotastine Besilate Nasal Spray 3% Twice a day~Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray"
11045030|NCT01277341|OG002|Outcome|4% Twice a Day|"Bepotastine Besilate Nasal Spray 4% Twice a day~Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray"
11045031|NCT01277341|OG003|Outcome|Placebo|"Placebo nasal spray~Placebo Nasal Spray: nasal spray"
11045032|NCT01277341|EG000|Reported Event|2% Twice a Day|"Bepotastine Besilate Nasal Spray 2% Twice a day~Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray"
11045033|NCT01277341|EG001|Reported Event|3% Twice a Day|"Bepotastine Besilate Nasal Spray 3% Twice a day~Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray"
11045034|NCT01277341|EG002|Reported Event|4% Twice a Day|"Bepotastine Besilate Nasal Spray 4% Twice a day~Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray"
11045035|NCT01277341|EG003|Reported Event|Placebo|"Placebo nasal spray~Placebo Nasal Spray: nasal spray"
11045036|NCT01277354|BG000|Baseline|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
11045037|NCT01277354|BG001|Baseline|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
11045038|NCT01277354|BG002|Baseline|Total|Total of all reporting groups
11045039|NCT01277354|FG000|Participant Flow|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
11045040|NCT01277354|FG001|Participant Flow|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
11045041|NCT01277354|OG000|Outcome|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
11045042|NCT01277354|OG001|Outcome|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
11045043|NCT01277354|EG000|Reported Event|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
11045044|NCT01277354|EG001|Reported Event|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
11045045|NCT01277510|BG000|Baseline|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
11045046|NCT01277510|BG001|Baseline|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
11045047|NCT01277510|BG002|Baseline|Total|Total of all reporting groups
11045048|NCT01277510|FG000|Participant Flow|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
11045049|NCT01277510|FG001|Participant Flow|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
11045050|NCT01277510|OG000|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
11045051|NCT01277510|OG001|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
11045052|NCT01277510|EG000|Reported Event|Double-blind Phase: Placebo|
11045053|NCT01277510|EG001|Reported Event|Double-blind Phase: Cinacalcet|
11045054|NCT01277510|EG002|Reported Event|Open-label Phase: Previous Placebo|
11045055|NCT01277510|EG003|Reported Event|Open-label Phase: Previous Cinacalcet|
11045056|NCT01277523|BG000|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045057|NCT01277523|BG001|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045058|NCT01277523|BG002|Baseline|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045059|NCT01277523|BG003|Baseline|Total|Total of all reporting groups
11045060|NCT01277523|FG000|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045061|NCT01277523|FG001|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045062|NCT01277523|FG002|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045063|NCT01277523|OG000|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045064|NCT01277523|OG001|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045065|NCT01277523|OG002|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045066|NCT01277523|EG000|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11066638|NCT01393457|EG001|Reported Event|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
11045067|NCT01277523|EG001|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045068|NCT01277523|EG002|Reported Event|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
11045069|NCT01277549|BG000|Baseline|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
11045070|NCT01277549|BG001|Baseline|Nonmobilized Donors|Donors not mobilized prior to MNC collection
11045071|NCT01277549|BG002|Baseline|Total|Total of all reporting groups
11045072|NCT01277549|FG000|Participant Flow|G-CSF Mobilized Donors|In this arm the donors received G-CSF (granulocyte colony stimulating factor) prior to the MNC (mononuclear cell) collection. G-CSF causes the mobilization of hematopoetic stem cells which are CD34 (cluster of differentiation 34) + to the peripheral blood. Collection efficiency of all mononuclear cells and of the CD34+ subset of mononuclear cells was assessed.
11045073|NCT01277549|FG001|Participant Flow|Non-mobilized Donors|In this arm, donors were not mobilized prior to mononuclear cell collection. Only collection efficiency of mononuclear cells could be assessed as CD34+ cells are not present in this population.
11045074|NCT01277549|OG000|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
11045075|NCT01277549|OG001|Outcome|Nonmobilized Donors|Donors were not mobilized prior to MNC collection.
11045076|NCT01277549|OG000|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
11045077|NCT01277549|OG001|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
11045078|NCT01277549|OG000|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
11226344|NCT02374138|BG001|Baseline|Intervention|"Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.~Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by community wellness coaches."
11045079|NCT01277549|EG000|Reported Event|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
11045080|NCT01277549|EG001|Reported Event|Nonmobilized Donors|"Donors not mobilized prior to MNC collection. Note that some Adverse Events (Flu-like symptoms, Muscle Aches, and Bone Pain) apply only to G-CSF mobilized donors. Nonmobilized donors were not assessed for these adverse events as they were not at risk."
11045081|NCT01277601|BG000|Baseline|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
11045082|NCT01277601|BG001|Baseline|TDF 48 Weeks + Peg-IFN 16 Week|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
11226345|NCT02374138|BG002|Baseline|Total|Total of all reporting groups
11045083|NCT01277601|BG002|Baseline|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
11045084|NCT01277601|BG003|Baseline|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
11045085|NCT01277601|BG004|Baseline|Total|Total of all reporting groups
11045086|NCT01277601|FG000|Participant Flow|TDF+Peg-IFN 48 Weeks|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks
11045087|NCT01277601|FG001|Participant Flow|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
11045088|NCT01277601|FG002|Participant Flow|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
11045089|NCT01277601|FG003|Participant Flow|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
11045090|NCT01277601|OG000|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
11045091|NCT01277601|OG001|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
11045092|NCT01277601|OG002|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
11045093|NCT01277601|OG000|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
11045094|NCT01277601|OG001|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
11045095|NCT01277601|OG002|Outcome|TDF 120 Week|TDF 300 mg tablet once daily for 120 weeks
11045096|NCT01277601|OG003|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
11045097|NCT01277601|OG002|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
11045098|NCT01277601|OG000|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
11045099|NCT01277601|OG001|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
11045100|NCT01277601|OG002|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
11045101|NCT01277601|OG003|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
11045102|NCT01277601|OG004|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
11045103|NCT01277601|OG005|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
11045104|NCT01277601|OG006|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
11045105|NCT01277601|OG000|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
11045106|NCT01277601|OG002|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
11045107|NCT01277601|OG005|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
11045108|NCT01277601|EG000|Reported Event|TDF+Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
11045109|NCT01277601|EG001|Reported Event|TDF+Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.~TDF 300 mg tablet once daily up to Week 120"
11045110|NCT01277601|EG002|Reported Event|TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks"
11045111|NCT01277601|EG003|Reported Event|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.~TDF 300 mg tablet once daily up to Week 120"
11045112|NCT01277601|EG004|Reported Event|TDF 120 Weeks|"Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days).~TDF 300 mg tablet once daily for up to 120 weeks"
11226346|NCT02374138|FG000|Participant Flow|Usual Care|"IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination~Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination"
11045113|NCT01277601|EG005|Reported Event|Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
11045114|NCT01277601|EG006|Reported Event|Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days).~TDF 300 mg tablet once daily up to Week 120"
11045115|NCT01277666|BG000|Baseline|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
11045116|NCT01277666|BG001|Baseline|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
11045117|NCT01277666|BG002|Baseline|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
11045118|NCT01277666|BG003|Baseline|Total|Total of all reporting groups
11045119|NCT01277666|FG000|Participant Flow|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period
11045120|NCT01277666|FG001|Participant Flow|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 milligram (mg) once daily hard gelatin capsules orally for 12 weeks treatment period
11045121|NCT01277666|FG002|Participant Flow|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period
11045122|NCT01277666|OG000|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
11045123|NCT01277666|OG001|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
11045124|NCT01277666|OG002|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
11045125|NCT01277666|EG000|Reported Event|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
11045126|NCT01277666|EG001|Reported Event|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
11045127|NCT01277666|EG002|Reported Event|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
11045128|NCT01277718|BG000|Baseline|Entire Study Population|All participants randomized to any treatment.
11045129|NCT01277718|FG000|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast. Treatment B in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized Food and Drug Administration (FDA) high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. There was minimum of a 13-day washout between cobimetinib doses of each period.
11066639|NCT01393457|EG002|Reported Event|Ldopa|levodopa/carbidopa 800/200 mg/d
11066640|NCT01393457|EG003|Reported Event|Placebo|Placebo
11066641|NCT01393600|BG000|Baseline|All Subjects|All randomized subjects who received at least one dose of study drug.
11045130|NCT01277718|FG001|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. Treatment B in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. There was minimum of a 13-day washout between cobimetinib doses of each period.
11045131|NCT01277718|OG000|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
11045132|NCT01277718|OG001|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
11045133|NCT01277718|OG002|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
11045134|NCT01277718|EG000|Reported Event|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
11045135|NCT01277718|EG001|Reported Event|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
11045136|NCT01277718|EG002|Reported Event|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
11045137|NCT01277744|BG000|Baseline|HIPEC|HIPEC with Cisplatin
11045138|NCT01277744|FG000|Participant Flow|HIPEC|HIPEC with Cisplatin
11045139|NCT01277744|OG000|Outcome|HIPEC|HIPEC with Cisplatin
11045140|NCT01277744|EG000|Reported Event|HIPEC|HIPEC with Cisplatin
11045141|NCT01277757|BG000|Baseline|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
11045142|NCT01277757|FG000|Participant Flow|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
11045143|NCT01277757|OG000|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
11045144|NCT01277757|EG000|Reported Event|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
11045145|NCT01277783|BG000|Baseline|Left Ventricular Endocardial Pacing|All enrolled patients were scheduled to receive a CRT implantation with endocardial LV lead
11045146|NCT01277783|FG000|Participant Flow|LV Endocardial Lead|"subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE.~Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery~Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery~Medtronic Model 3830: Endocardial Left Ventricular pacing"
11045147|NCT01277783|OG000|Outcome|LV Endocardial Lead|"subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE.~Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery~Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery~Medtronic Model 3830: Endocardial Left Ventricular pacing"
11045148|NCT01277783|OG000|Outcome|Left Ventricular Endocardial Pacing|"subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE.~Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing"
11045149|NCT01277783|EG000|Reported Event|Left Ventricular Endocardial Pacing|"subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE.~Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing"
11045150|NCT01277861|BG000|Baseline|FENTANYL|FENTANYL
11045151|NCT01277861|BG001|Baseline|SALINE|SALINE
11045152|NCT01277861|BG002|Baseline|Total|Total of all reporting groups
11045153|NCT01277861|FG000|Participant Flow|FENTANYL|FENTANYL
11045154|NCT01277861|FG001|Participant Flow|SALINE|SALINE
11045155|NCT01277861|OG000|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
11045156|NCT01277861|OG001|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
11045157|NCT01277861|OG000|Outcome|Fentanyl Pretreatment Group|
11045158|NCT01277861|OG001|Outcome|Saline Pretreatment Group|
11045159|NCT01277861|EG000|Reported Event|FENTANYL|FENTANYL
11045160|NCT01277861|EG001|Reported Event|SALINE|SALINE
11045161|NCT01277887|BG000|Baseline|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
11045162|NCT01277887|BG001|Baseline|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
11045163|NCT01277887|BG002|Baseline|Total|Total of all reporting groups
11045164|NCT01277887|FG000|Participant Flow|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
11045165|NCT01277887|FG001|Participant Flow|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
11045166|NCT01277887|OG000|Outcome|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
11045167|NCT01277887|OG001|Outcome|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
11045168|NCT01277887|EG000|Reported Event|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
11045169|NCT01277887|EG001|Reported Event|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
11045170|NCT01278030|BG000|Baseline|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
11045171|NCT01278030|BG001|Baseline|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
11045172|NCT01278030|BG002|Baseline|Total|Total of all reporting groups
11045173|NCT01278030|FG000|Participant Flow|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
11045174|NCT01278030|FG001|Participant Flow|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
11045175|NCT01278030|OG000|Outcome|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
11045176|NCT01278030|OG001|Outcome|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
11045177|NCT01278030|EG000|Reported Event|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
11045178|NCT01278030|EG001|Reported Event|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
11045179|NCT01278160|BG000|Baseline|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
11066642|NCT01393600|FG000|Participant Flow|Placebo, Then Valbenazine 12.5 mg|Participants first received Placebo (matching valbenazine solution) once daily from Day 1 to 14, then they received valbenazine 12.5 mg solution once daily from Day 15 to 28.
11045180|NCT01278160|BG001|Baseline|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
11045181|NCT01278160|BG002|Baseline|Total|Total of all reporting groups
11045182|NCT01278160|FG000|Participant Flow|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
11045183|NCT01278160|FG001|Participant Flow|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
11045184|NCT01278160|OG000|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
11045185|NCT01278160|OG001|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
11045186|NCT01278160|EG000|Reported Event|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
11045187|NCT01278160|EG001|Reported Event|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
11045188|NCT01278173|BG000|Baseline|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
11045189|NCT01278173|FG000|Participant Flow|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
11045190|NCT01278173|OG000|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
11045191|NCT01278173|EG000|Reported Event|Vigabatrin|
11045192|NCT01278303|BG000|Baseline|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
11045193|NCT01278303|FG000|Participant Flow|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
11045194|NCT01278303|OG000|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
11045195|NCT01278303|EG000|Reported Event|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
11045196|NCT01278342|BG000|Baseline|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
11045197|NCT01278342|BG001|Baseline|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
11045198|NCT01278342|BG002|Baseline|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
11045199|NCT01278342|BG003|Baseline|Total|Total of all reporting groups
11045200|NCT01278342|FG000|Participant Flow|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
11045201|NCT01278342|FG001|Participant Flow|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
11045202|NCT01278342|FG002|Participant Flow|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
11045203|NCT01278342|OG000|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
11045204|NCT01278342|OG001|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
11045205|NCT01278342|OG002|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
11045206|NCT01278342|EG000|Reported Event|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months
11045207|NCT01278342|EG001|Reported Event|Sandostatin LAR High Dose + Pegvisomant|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
11045208|NCT01278342|EG002|Reported Event|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
11045209|NCT01278394|BG000|Baseline|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
11045210|NCT01278394|FG000|Participant Flow|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
11045211|NCT01278394|OG000|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
11045212|NCT01278394|EG000|Reported Event|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
11045213|NCT01278407|BG000|Baseline|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
11045214|NCT01278407|BG001|Baseline|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
11045215|NCT01278407|BG002|Baseline|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
11045216|NCT01278407|BG003|Baseline|Total|Total of all reporting groups
11045217|NCT01278407|FG000|Participant Flow|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
11045218|NCT01278407|FG001|Participant Flow|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
11045219|NCT01278407|FG002|Participant Flow|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
11045220|NCT01278407|FG003|Participant Flow|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
11045221|NCT01278407|FG004|Participant Flow|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
11045222|NCT01278407|OG000|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
11045223|NCT01278407|OG001|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
11045224|NCT01278407|OG002|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
11045225|NCT01278407|EG000|Reported Event|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
11045226|NCT01278407|EG001|Reported Event|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
11045227|NCT01278407|EG002|Reported Event|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
11045228|NCT01278407|EG003|Reported Event|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
11045229|NCT01278407|EG004|Reported Event|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
11045230|NCT01278485|BG000|Baseline|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
11045231|NCT01278485|FG000|Participant Flow|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
11045232|NCT01278485|OG000|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
11045233|NCT01278485|EG000|Reported Event|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
11045234|NCT01278615|BG000|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11045235|NCT01278615|FG000|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11045236|NCT01278615|OG000|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11045237|NCT01278615|EG000|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11045238|NCT01278745|BG000|Baseline|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
11045239|NCT01278745|BG001|Baseline|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
10887089|NCT00498615|OG001|Outcome|40 mg Fasudil|"Time to reach 70% skin temperature after cold challenge done 2 hrs after dosing.~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
11045240|NCT01278745|BG002|Baseline|Total|Total of all reporting groups
11066643|NCT01393600|FG001|Participant Flow|Valbenazine 12.5 mg, Then Placebo|Participants first received valbenazine 12.5 mg solution once daily from Day 1 to 14, then they received Placebo (matching valbenazine solution) once daily from Day 15 to 28.
10887271|NCT00499603|OG001|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
11045241|NCT01278745|FG000|Participant Flow|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
11045242|NCT01278745|FG001|Participant Flow|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
11045243|NCT01278745|FG002|Participant Flow|Discontinued Pre-Transplant|Subjects that enrolled, but withdrew from the study prior to their transplant.
11045244|NCT01278745|FG003|Participant Flow|Discontinued Pre-Randomization|Subjects that were enrolled and transplanted on study, but withdrew from the study prior to randomization.
11045245|NCT01278745|OG000|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
11045246|NCT01278745|OG001|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
11045247|NCT01278745|EG000|Reported Event|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
11045248|NCT01278745|EG001|Reported Event|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
11045249|NCT01278745|EG002|Reported Event|Discontinued Pre-Transplant|Subjects that enrolled, but withdrew from the study prior to their transplant.
11045250|NCT01278745|EG003|Reported Event|Discontinued Pre-Randomization|Subjects that were enrolled and transplanted on study, but withdrew from the study prior to randomization.
11066644|NCT01393600|FG002|Participant Flow|Placebo, Then Valbenazine 50 mg|Participants first received Placebo (matching valbenazine solution) once daily from Day 1 to 14, then they received valbenazine 50 mg solution once daily from Day 15 to 28.
11066645|NCT01393600|FG003|Participant Flow|Valbenazine 50 mg, Then Placebo|Participants first received valbenazine 50 mg solution once daily from Day 1 to 14, then they received Placebo (matching valbenazine solution) once daily from Day 15 to 28.
11066646|NCT01393600|OG000|Outcome|Placebo|Placebo (matching valbenazine solution)
11066647|NCT01393600|OG001|Outcome|Valbenazine 12.5 mg|Valbenazine 12.5 mg solution
11066648|NCT01393600|OG002|Outcome|Valbenazine 50 mg|Valbenazine 50 mg solution
11066649|NCT01393600|OG000|Outcome|Valbenazine 12.5mg Placebo|Participants who received Placebo (matching valbenazine 12.5mg solution) once daily from Day 1 to 14 and participants who received Placebo (matching valbenazine 12.5mg solution) from Day 15 to 28.
11066650|NCT01393600|OG001|Outcome|Valbenazine 12.5mg|Participants who received valbenazine 12.5mg solution once daily from Day 1 to 14 and participants who received valbenazine 12.5mg solution from Day 15 to 28.
11066651|NCT01393600|OG002|Outcome|Valbenazine 50mg Placebo|Participants who received Placebo (matching valbenazine 50mg solution) once daily from Day 1 to 14 and participants who received Placebo (matching valbenazine 50mg solution) from Day 15 to 28.
11066652|NCT01393600|OG003|Outcome|Valbenazine 50mg|Participants who received valbenazine 50mg solution once daily from Day 1 to 14 and participants who received valbenazine 50mg solution from Day 15 to 28.
11066653|NCT01393600|EG000|Reported Event|Placebo|Placebo (matching NBI-98854 solution) for 28 days followed by 7 days of posttreatment.
11066654|NCT01393600|EG001|Reported Event|NBI-98854 12.5 mg|NBI-98854 12.5 mg solution for 28 days followed by 7 days of posttreatment.
11066655|NCT01393600|EG002|Reported Event|NBI-98854 50 mg|NBI-98854 50 mg solution for 28 days followed by 7 days of posttreatment.
11066656|NCT01393613|BG000|Baseline|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
11066657|NCT01393613|BG001|Baseline|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
11066658|NCT01393613|BG002|Baseline|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
11066659|NCT01393613|BG003|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
11066660|NCT01393613|BG004|Baseline|Total|Total of all reporting groups
11066661|NCT01393613|FG000|Participant Flow|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
11066662|NCT01393613|FG001|Participant Flow|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
11066663|NCT01393613|FG002|Participant Flow|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
11066664|NCT01393613|FG003|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
11066665|NCT01393613|OG000|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
11066666|NCT01393613|OG001|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
11066667|NCT01393613|OG002|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
11066668|NCT01393613|OG003|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
11066669|NCT01393613|OG002|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
11066670|NCT01393613|OG003|Outcome|Placebo|Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
11066671|NCT01393613|EG000|Reported Event|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
11066672|NCT01393613|EG001|Reported Event|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
11066673|NCT01393613|EG002|Reported Event|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
11066674|NCT01393613|EG003|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
11066675|NCT01393626|BG000|Baseline|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
11066676|NCT01393626|BG001|Baseline|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
11066677|NCT01393626|BG002|Baseline|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
11066678|NCT01393626|BG003|Baseline|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
11066679|NCT01393626|BG004|Baseline|Total|Total of all reporting groups
11066680|NCT01393626|FG000|Participant Flow|Placebo|Placebo tablets to match tofacitinib 5 milligrams (mg) for oral administration twice daily (BID) for 8 weeks.
11066681|NCT01393626|FG001|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
11066682|NCT01393626|FG002|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
11066683|NCT01393626|FG003|Participant Flow|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
11066684|NCT01393626|OG000|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
11066685|NCT01393626|OG001|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
11066686|NCT01393626|OG002|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
11066687|NCT01393626|OG003|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
11066688|NCT01393626|OG000|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
11066689|NCT01393626|OG001|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
11066690|NCT01393626|OG002|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
11045251|NCT01278797|BG000|Baseline|Entire Study Population|Includes all subjects randomized to either treatment sequence
11045252|NCT01278797|FG000|Participant Flow|Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg|Combination tablet followed by individual components
11045253|NCT01278797|FG001|Participant Flow|Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg|Individual components followed by Combination tablet
11045254|NCT01278797|OG000|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
11045255|NCT01278797|OG001|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
11045256|NCT01278797|EG000|Reported Event|Telm/Amlo 80 mg/10 mg|Combination tablet
11045257|NCT01278797|EG001|Reported Event|Telm 80 mg + Amlo 10 mg|Individual tablets
11045258|NCT01278862|BG000|Baseline|DVS Veneer|"veneer made by CAD/CAM method~DVS veneer: CAD/CAM milled porcelain veneer for Lava crown"
11045259|NCT01278862|BG001|Baseline|Conventional Veneer|"Veneer made by laboratory technician~DVS veneer: CAD/CAM milled porcelain veneer for Lava crown"
11045260|NCT01278862|BG002|Baseline|Total|Total of all reporting groups
11045261|NCT01278862|FG000|Participant Flow|DVS Veneer|"veneer made by CAD/CAM method~DVS veneer: CAD/CAM milled porcelain veneer for Lava crown"
11045262|NCT01278862|FG001|Participant Flow|Conventional Veneer|"Veneer made by laboratory technician~DVS veneer: CAD/CAM milled porcelain veneer for Lava crown"
11045263|NCT01278862|OG000|Outcome|DVS Veneer|"veneer made by CAD/CAM method~DVS veneer: CAD/CAM milled porcelain veneer for Lava crown"
11045264|NCT01278862|OG001|Outcome|Conventional Veneer|"Veneer made by laboratory technician~DVS veneer: CAD/CAM milled porcelain veneer for Lava crown"
11045265|NCT01278862|EG000|Reported Event|DVS Veneer|"veneer made by CAD/CAM method~DVS veneer: CAD/CAM milled porcelain veneer for Lava crown"
11045266|NCT01278862|EG001|Reported Event|Conventional Veneer|"Veneer made by laboratory technician~DVS veneer: CAD/CAM milled porcelain veneer for Lava crown"
11045267|NCT01278927|BG000|Baseline|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
11045268|NCT01278927|BG001|Baseline|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
11045269|NCT01278927|BG002|Baseline|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
11045270|NCT01278927|BG003|Baseline|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
11045271|NCT01278927|BG004|Baseline|Total|Total of all reporting groups
11045272|NCT01278927|FG000|Participant Flow|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
11045273|NCT01278927|FG001|Participant Flow|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
11045274|NCT01278927|FG002|Participant Flow|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
11045275|NCT01278927|FG003|Participant Flow|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
11045276|NCT01278927|OG000|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
11045277|NCT01278927|OG001|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
11045278|NCT01278927|OG002|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
11045279|NCT01278927|OG003|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
11045280|NCT01278927|OG002|Outcome|Exercise and Stress Management|Exercise and Stress Management - Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
11045281|NCT01278927|EG000|Reported Event|Exercise|"Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.~Exercise: Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention."
11045282|NCT01278927|EG001|Reported Event|Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.~Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention."
11066691|NCT01393626|OG000|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
11066692|NCT01393626|OG001|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
11045283|NCT01278927|EG002|Reported Event|Exercise and Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.~Exercise and Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions."
11045284|NCT01278927|EG003|Reported Event|Standard Care|"Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).~Standard Care: Patients randomized to standard care only will be informed of their assigned condition and receive the DVD."
11045285|NCT01278953|BG000|Baseline|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
11045286|NCT01278953|BG001|Baseline|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
11045287|NCT01278953|BG002|Baseline|Total|Total of all reporting groups
11045288|NCT01278953|FG000|Participant Flow|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
11045289|NCT01278953|FG001|Participant Flow|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
11045290|NCT01278953|OG000|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
11045291|NCT01278953|OG001|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
11045292|NCT01278953|EG000|Reported Event|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
11045293|NCT01278953|EG001|Reported Event|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
11045294|NCT01279044|BG000|Baseline|Phase 1 - Formative Research|Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling
11226347|NCT02374138|FG001|Participant Flow|Intervention|"Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.~Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by community wellness coaches."
11045295|NCT01279044|BG001|Baseline|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
11045296|NCT01279044|BG002|Baseline|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
11045297|NCT01279044|BG003|Baseline|Total|Total of all reporting groups
11045298|NCT01279044|FG000|Participant Flow|Formative Phase 1|Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling
11045299|NCT01279044|FG001|Participant Flow|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
11045300|NCT01279044|FG002|Participant Flow|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
11045301|NCT01279044|OG000|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
11045302|NCT01279044|OG001|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
11045303|NCT01279044|EG000|Reported Event|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
11045304|NCT01279044|EG001|Reported Event|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
11045305|NCT01279057|BG000|Baseline|Test|Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
11045306|NCT01279057|BG001|Baseline|Reference|Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
11045307|NCT01279057|BG002|Baseline|Placebo|Placebo nasal spray administered once daily for 14 days.
11045308|NCT01279057|BG003|Baseline|Total|Total of all reporting groups
11045309|NCT01279057|FG000|Participant Flow|Test|Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
11045310|NCT01279057|FG001|Participant Flow|Reference|Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
11045311|NCT01279057|FG002|Participant Flow|Placebo|Placebo nasal spray administered once daily for 14 days.
11045312|NCT01279057|OG000|Outcome|Test|Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
11045313|NCT01279057|OG001|Outcome|Reference|Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
11045314|NCT01279057|OG002|Outcome|Placebo|Placebo nasal spray administered once daily for 14 days.
11045315|NCT01279057|EG000|Reported Event|Test|Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
11045316|NCT01279057|EG001|Reported Event|Reference|Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
11045317|NCT01279057|EG002|Reported Event|Placebo|Placebo nasal spray administered once daily for 14 days.
11045318|NCT01279070|BG000|Baseline|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
11045319|NCT01279070|BG001|Baseline|Repyflec Training|Cognitive remediation treatment
11045320|NCT01279070|BG002|Baseline|Total|Total of all reporting groups
11045321|NCT01279070|FG000|Participant Flow|Experimental Group (Repyflec Cognitive Remediation)|"Cognitive remediation (CR) group training (Repyflec)~REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations,examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF)."
11045322|NCT01279070|FG001|Participant Flow|Leisure Group (Control Group)|"Leisure group~Parallel to the experimental group, a leisure control group was established which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, etc.) over 4 months twice a week and lasting 1 h."
11045323|NCT01279070|OG000|Outcome|REPYFLEC Cognitive Remediation Group Training|REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
11045324|NCT01279070|OG001|Outcome|Leisure & Socialization Group|"The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, coffee & talk, geography review, etc.)without specific goals."
11045325|NCT01279070|OG000|Outcome|REPYFLEC Cognitive Group Trainining|"REPYFLEC is a strategy-based training, explicitly described from session to session, which is carried out using pencil and paper with a blackboard as visual support. This format allows results to be replicated with rigour. The working content is divided into two principal areas: Problem solving (PS) and Cognitive Flexibility (CF). In the PS block, training in executive function, the thinking process and self-monitoring was emphasized. In the CF block, the tasks require the use of cognitive flexibility for successful completion. Some activities seek to promote training of other functions such as memory, working memory, sustained attention and language. Development of training was performed taking into account the contextual bases of learning, mainly using techniques as modelling to foster coping abilities, molding, self-monitoring, errorless learning and Socratic questioning. REPYFLEC is carried out in a group format (4-6), consisting of 32 sessions lasting 1 hour."
11045326|NCT01279070|OG001|Outcome|Leisure & Socialization Group|"Parallel to the experimental group, a leisure group was established (control group) which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, geography review, etc)."
11045327|NCT01279070|OG000|Outcome|Repyflec Training|Cognitive remediation treatment
11045328|NCT01279070|OG001|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
11045329|NCT01279070|EG000|Reported Event|Leisure Group|Stimulating activities without specific goals and focused on leisure
11045330|NCT01279070|EG001|Reported Event|Repyflec Training|Cognitive remediation group treatment based on Problem Solving and Cognitive Flexibility
11045331|NCT01279109|BG000|Baseline|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
11045332|NCT01279109|BG001|Baseline|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
11045333|NCT01279109|BG002|Baseline|Total|Total of all reporting groups
11045334|NCT01279109|FG000|Participant Flow|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
11045335|NCT01279109|FG001|Participant Flow|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
11045336|NCT01279109|OG000|Outcome|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
11045337|NCT01279109|OG001|Outcome|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
11045338|NCT01279109|EG000|Reported Event|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
11045339|NCT01279109|EG001|Reported Event|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
11045340|NCT01279187|BG000|Baseline|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
11045341|NCT01279187|BG001|Baseline|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
11045342|NCT01279187|BG002|Baseline|Total|Total of all reporting groups
11045343|NCT01279187|FG000|Participant Flow|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
11045344|NCT01279187|FG001|Participant Flow|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
11045345|NCT01279187|OG000|Outcome|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
11045346|NCT01279187|OG001|Outcome|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
11045347|NCT01279187|EG000|Reported Event|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
11066693|NCT01393626|OG002|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
11045348|NCT01279187|EG001|Reported Event|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
11045349|NCT01279200|BG000|Baseline|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
11045350|NCT01279200|BG001|Baseline|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
11045351|NCT01279200|BG002|Baseline|Total|Total of all reporting groups
11045352|NCT01279200|FG000|Participant Flow|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
11045353|NCT01279200|FG001|Participant Flow|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
11045354|NCT01279200|OG000|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
11045355|NCT01279200|OG001|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
11045356|NCT01279200|EG000|Reported Event|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
11045357|NCT01279200|EG001|Reported Event|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
11045358|NCT01279265|BG000|Baseline|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
11045359|NCT01279265|BG001|Baseline|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
11045360|NCT01279265|BG002|Baseline|Total|Total of all reporting groups
11045361|NCT01279265|FG000|Participant Flow|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
11045362|NCT01279265|FG001|Participant Flow|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
11045363|NCT01279265|OG000|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
11045364|NCT01279265|OG001|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
11045365|NCT01279265|OG000|Outcome|Nutramigen Lipil With Enflora|"Formula with probiotics (Lactobaccillus Rhamnosus GG)~Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG"
11045366|NCT01279265|OG001|Outcome|Nutramigen A+|"Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)~Nutramigen A+: Hypoallergenic formula without lactobacillus"
11045367|NCT01279265|EG000|Reported Event|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
11045368|NCT01279265|EG001|Reported Event|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
11045369|NCT01279317|BG000|Baseline|Vinegar Co-ingestion|All participants performed both intervention periods.
11045370|NCT01279317|FG000|Participant Flow|Vinegar Co-ingestion First, Then Placebo Co-intestion|First acute experiment with vinegar-coingestion (1 day), after 1 week washout, experiment with placebo co-ingestion (1 day).
11045371|NCT01279317|FG001|Participant Flow|Placebo Co-ingestion First, Then Vinegar Co-ingestion|First acute experiment with placebo-coingestion (1 day), after 1 week washout experiment with vinegar co-ingestion (1 day).
11045372|NCT01279317|OG000|Outcome|Vinegar Co-ingestion|
11045373|NCT01279317|OG001|Outcome|Placebo Co-ingestion|
11045374|NCT01279317|EG000|Reported Event|Vinegar Co-ingestion|All participants performed both intervention periods.
11045375|NCT01279343|BG000|Baseline|Foley Bulb Plus Misoprostol|In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.
11045376|NCT01279343|BG001|Baseline|Misoprostol|The participants in this arm received misoprostol 25 micrograms every 4 hours.
11045377|NCT01279343|BG002|Baseline|Total|Total of all reporting groups
11045378|NCT01279343|FG000|Participant Flow|Foley Bulb Plus Misoprostol|In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.
11045379|NCT01279343|FG001|Participant Flow|Misoprostol|The participants in this arm received misoprostol 25 micrograms every 4 hours.
11045380|NCT01279343|OG000|Outcome|Foley Bulb Plus Misoprostol|In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.
11045381|NCT01279343|OG001|Outcome|Misoprostol|The participants in this arm received misoprostol 25 micrograms every 4 hours.
11045382|NCT01279343|EG000|Reported Event|Foley Bulb Plus Misoprostol|In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.
11045383|NCT01279343|EG001|Reported Event|Misoprostol|The participants in this arm received misoprostol 25 micrograms every 4 hours.
11045384|NCT01279447|BG000|Baseline|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
11045385|NCT01279447|BG001|Baseline|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
11045386|NCT01279447|BG002|Baseline|Total|Total of all reporting groups
11045387|NCT01279447|FG000|Participant Flow|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
11045388|NCT01279447|FG001|Participant Flow|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
11045389|NCT01279447|OG000|Outcome|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
11045390|NCT01279447|OG001|Outcome|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
11045391|NCT01279447|EG000|Reported Event|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
11045392|NCT01279447|EG001|Reported Event|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
11045393|NCT01279486|BG000|Baseline|Pregnancy Test|"Volunteers were instructed to carry out the pregnancy test according to the instruction leaflet and collect a urine sample from the same void into the provided urine container. Volunteers were told to conduct the test according to the instruction leaflet. No other instructions were given. Volunteers were free to choose the in-stream or dip method of sampling."
11045394|NCT01279486|FG000|Participant Flow|Pregnancy Test|"Volunteers were instructed to carry out the pregnancy test according to the instruction leaflet and collect a urine sample from the same void into the provided urine container. Volunteers were told to conduct the test according to the instruction leaflet. No other instructions were given. Volunteers were free to choose the in-stream or dip method of sampling."
11045395|NCT01279486|OG000|Outcome|Pregnancy Test|"Volunteers were instructed to carry out the pregnancy test according to the instruction leaflet and collect a urine sample from the same void into the provided urine container. Volunteers were told to conduct the test according to the instruction leaflet. No other instructions were given. Volunteers were free to choose the in-stream or dip method of sampling."
11045396|NCT01279486|EG000|Reported Event|Pregnancy Test|"Volunteers were instructed to carry out the pregnancy test according to the instruction leaflet and collect a urine sample from the same void into the provided urine container. Volunteers were told to conduct the test according to the instruction leaflet. No other instructions were given. Volunteers were free to choose the in-stream or dip method of sampling."
11045397|NCT01279564|BG000|Baseline|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation"
11045398|NCT01279564|BG001|Baseline|Control|"Intubation~Endotracheal tube: Intubation"
11045399|NCT01279564|BG002|Baseline|Total|Total of all reporting groups
11045400|NCT01279564|FG000|Participant Flow|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation"
11045401|NCT01279564|FG001|Participant Flow|Control|"Intubation~Endotracheal tube- standard"
11045402|NCT01279564|OG000|Outcome|ETview|"Endotracheal intubation with ETview TVT~Duration of intubation"
11045403|NCT01279564|OG001|Outcome|Control|"Intubation~Duration of intubation"
11045404|NCT01279564|EG000|Reported Event|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation~No adverse events"
11045405|NCT01279564|EG001|Reported Event|Control|"Intubation~Endotracheal tube: Intubation~No adverse events"
11045406|NCT01279681|BG000|Baseline|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11045407|NCT01279681|BG001|Baseline|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11045408|NCT01279681|BG002|Baseline|Total|Total of all reporting groups
11045409|NCT01279681|FG000|Participant Flow|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11066694|NCT01393626|OG003|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
11045410|NCT01279681|FG001|Participant Flow|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11045411|NCT01279681|OG000|Outcome|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11045412|NCT01279681|OG001|Outcome|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11045413|NCT01279681|EG000|Reported Event|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11045414|NCT01279681|EG001|Reported Event|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11045415|NCT01279850|BG000|Baseline|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
11045416|NCT01279850|FG000|Participant Flow|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
11045417|NCT01279850|OG000|Outcome|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
11045418|NCT01279850|EG000|Reported Event|LYRICA Capsules (Pregabalin)|Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
11045419|NCT01279954|BG000|Baseline|Open-label Abatacept, Then 10 mg/kg Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then 10 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045420|NCT01279954|BG001|Baseline|Open-label Abatacept, Then 5 mg/kg Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then 5 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045421|NCT01279954|BG002|Baseline|Total|Total of all reporting groups
11045422|NCT01279954|FG000|Participant Flow|Open-label Abatacept, Then 10 mg/kg Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then 10 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045423|NCT01279954|FG001|Participant Flow|Open-label Abatacept, Then 5mg/kg Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then 5 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045424|NCT01279954|OG000|Outcome|Randomized 10 mg/kg Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then continue receiving 10 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045425|NCT01279954|OG001|Outcome|Randomized 5 mg/kg Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then receive 5 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045426|NCT01279954|OG002|Outcome|Open Label Abatacept|All subjects received open label 10mg/kg abatacept during the first 24 weeks of the trial.
11066695|NCT01393626|EG000|Reported Event|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
11045427|NCT01279954|OG000|Outcome|Open-label Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045428|NCT01279954|EG000|Reported Event|10 mg/kg Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then receive 10 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045429|NCT01279954|EG001|Reported Event|5 mg/kg Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then receive 5 mg/kg.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045430|NCT01279954|EG002|Reported Event|Open Label Abatacept|"Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial.~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
11045431|NCT01280058|BG000|Baseline|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
11045432|NCT01280058|BG001|Baseline|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
11045433|NCT01280058|BG002|Baseline|Total|Total of all reporting groups
11045434|NCT01280058|FG000|Participant Flow|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
11045435|NCT01280058|FG001|Participant Flow|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
11045436|NCT01280058|OG000|Outcome|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
11045437|NCT01280058|OG001|Outcome|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
11045438|NCT01280058|OG000|Outcome|Arm I (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
11045439|NCT01280058|OG001|Outcome|Arm II (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
11045440|NCT01280058|EG000|Reported Event|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin and Paclitaxel were given IV. Wild-type Reovirus: Given IV
11045441|NCT01280058|EG001|Reported Event|Arm B (Carboplatin, Paclitaxel)|Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Carboplatin and Paclitaxel were given IV
11045442|NCT01280110|BG000|Baseline|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
11045443|NCT01280110|BG001|Baseline|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
11045444|NCT01280110|BG002|Baseline|Total|Total of all reporting groups
11045445|NCT01280110|FG000|Participant Flow|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
11045446|NCT01280110|FG001|Participant Flow|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
11045447|NCT01280110|OG000|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
11045448|NCT01280110|OG001|Outcome|Preservative-free Lubricating Drops|he second group will receive preservative-free lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
11045449|NCT01280110|OG000|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
11045450|NCT01280110|OG001|Outcome|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
11045451|NCT01280110|EG000|Reported Event|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
11045452|NCT01280110|EG001|Reported Event|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
11045453|NCT01280123|BG000|Baseline|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
11045454|NCT01280123|BG001|Baseline|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
11045455|NCT01280123|BG002|Baseline|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
11045456|NCT01280123|BG003|Baseline|Total|Total of all reporting groups
11045457|NCT01280123|FG000|Participant Flow|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
11045458|NCT01280123|FG001|Participant Flow|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
11045459|NCT01280123|FG002|Participant Flow|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
11045460|NCT01280123|OG000|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
11226348|NCT02374138|OG000|Outcome|Usual Care|"IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination~Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination"
11226349|NCT02374138|OG001|Outcome|Intervention|"Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.~Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by community wellness coaches."
11045461|NCT01280123|OG001|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
11045462|NCT01280123|OG002|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
11045463|NCT01280123|EG000|Reported Event|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
11045464|NCT01280123|EG001|Reported Event|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
11066696|NCT01393626|EG001|Reported Event|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
11045465|NCT01280123|EG002|Reported Event|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
11045466|NCT01280201|BG000|Baseline|Arm of Pazopanib|Single arm of pazopanib 800 mg, administered once a day as the only treatment.
11045467|NCT01280201|FG000|Participant Flow|Arm of Pazopanib|Single arm of pazopanib 800 mg, administered once a day as the only treatment.
11045468|NCT01280201|OG000|Outcome|Arm of Pazopanib|Single arm of pazopanib 800 mg, administered once a day as the only treatment.
11045469|NCT01280201|EG000|Reported Event|Arm of Pazopanib|Single arm of pazopanib 800 mg, administered once a day as the only treatment.
11045470|NCT01280266|BG000|Baseline|Amlodipine-Udenafil (AU) Arm|Amlodipine first, then Udenafil
11045471|NCT01280266|BG001|Baseline|Udenafil-Amlodipine (UA) Arm|Udenafil first, then Amlodipine
11045472|NCT01280266|BG002|Baseline|Total|Total of all reporting groups
10887314|NCT00499694|FG000|Participant Flow|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
11045473|NCT01280266|FG000|Participant Flow|Amlodipine-Udenafil (AU) Arm|Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks.
11045474|NCT01280266|FG001|Participant Flow|Udenafil-Amlodipine (UA) Arm|Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks.
11045475|NCT01280266|OG000|Outcome|Amlodipine|Changes in RP attacks per day during amlodipine 10 mg orally per day
11045476|NCT01280266|OG001|Outcome|Udenafil|Changes in RP attacks per day during udenafil 100mg orally per day
11045477|NCT01280266|OG000|Outcome|Amlodipine|Changes in RPS during amlodipine 100 mg orally per day
11045478|NCT01280266|OG001|Outcome|Udenafil|Changes in RPS during udenafil 10 mg orally per day
11045479|NCT01280266|OG000|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
11045480|NCT01280266|OG001|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
11045481|NCT01280266|EG000|Reported Event|Amlodipine|Adverse effects observed while taking amlodipine in both study arms
11045482|NCT01280266|EG001|Reported Event|Udenafil|Adverse effects observed while taking udenafil in both study arms
11045483|NCT01280357|BG000|Baseline|Monitor With the Philips 50XM, Remove Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the predicate Tocco device
11045484|NCT01280357|FG000|Participant Flow|All Participants|during labor & delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 & the Philips 50XM
11045485|NCT01280357|OG000|Outcome|All Participants|Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.
11045486|NCT01280357|OG000|Outcome|All Participants|all participants that had fetal heart rate measured with the Monica AN24 & the Philips 50XM
11045487|NCT01280357|OG000|Outcome|All Participants|all participants that had maternal heart rate measured with the Monica AN24 & the Philips 50XM
11045488|NCT01280357|EG000|Reported Event|Philips 50XM,|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
11045489|NCT01280357|EG001|Reported Event|Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
11045490|NCT01280409|BG000|Baseline|Placebo|"Compounded placebo~Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks."
11045491|NCT01280409|BG001|Baseline|Metformin|"Compounded metformin as the intervention~Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks"
11045492|NCT01280409|BG002|Baseline|Total|Total of all reporting groups
11045493|NCT01280409|FG000|Participant Flow|Placebo|"Compounded placebo~Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks."
11045494|NCT01280409|FG001|Participant Flow|Metformin|"Compounded metformin as the intervention~Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks"
11045495|NCT01280409|OG000|Outcome|Placebo|"Compounded placebo~Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks."
11045496|NCT01280409|OG001|Outcome|Metformin|"Compounded metformin as the intervention~Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks"
11045497|NCT01280409|EG000|Reported Event|Placebo|"Compounded placebo~Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks."
11045498|NCT01280409|EG001|Reported Event|Metformin|"Compounded metformin as the intervention~Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks"
11045499|NCT01280552|BG000|Baseline|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
11045500|NCT01280552|BG001|Baseline|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
11045501|NCT01280552|BG002|Baseline|Total|Total of all reporting groups
11045502|NCT01280552|FG000|Participant Flow|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
11045503|NCT01280552|FG001|Participant Flow|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
11045504|NCT01280552|OG000|Outcome|ICT-107|Treatment with autologous dendritic cells pulsed with immunogenic peptides
11045505|NCT01280552|OG001|Outcome|Control Dendritic Cells|Treatment with autologous dendritic cells not pulsed with immunogenic peptides
11045506|NCT01280552|OG000|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
11045507|NCT01280552|OG001|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
11045508|NCT01280552|OG001|Outcome|Control|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
11045509|NCT01280552|EG000|Reported Event|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
11045510|NCT01280552|EG001|Reported Event|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
11045511|NCT01280591|BG000|Baseline|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
11045512|NCT01280591|BG001|Baseline|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
11045513|NCT01280591|BG002|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
11045514|NCT01280591|BG003|Baseline|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
11045515|NCT01280591|BG004|Baseline|Total|Total of all reporting groups
11045516|NCT01280591|FG000|Participant Flow|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
11045517|NCT01280591|FG001|Participant Flow|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
11045518|NCT01280591|FG002|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
11045519|NCT01280591|FG003|Participant Flow|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
11045520|NCT01280591|OG000|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
11045521|NCT01280591|OG001|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
11045522|NCT01280591|OG002|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
11045523|NCT01280591|OG003|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
11045524|NCT01280591|EG000|Reported Event|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
11045525|NCT01280591|EG001|Reported Event|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
11045526|NCT01280591|EG002|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
11045527|NCT01280591|EG003|Reported Event|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
11045528|NCT01280604|BG000|Baseline|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
11045529|NCT01280604|BG001|Baseline|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
11045530|NCT01280604|BG002|Baseline|Total|Total of all reporting groups
11045531|NCT01280604|FG000|Participant Flow|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
11045532|NCT01280604|FG001|Participant Flow|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
11045533|NCT01280604|OG000|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
11045534|NCT01280604|OG001|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
11045535|NCT01280604|EG000|Reported Event|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
11045536|NCT01280604|EG001|Reported Event|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
11045537|NCT01280617|BG000|Baseline|Thymoglobulin 1.25mg/kg Dose|"The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.~Thymoglobulin: Thymoglobulin 1.25mg/kg dose"
11045538|NCT01280617|BG001|Baseline|Thymoglobulin 0.75mg/kg Dose|"The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.~Thymoglobulin 0.75mg/kg dose: Thymoglobulin"
11045539|NCT01280617|BG002|Baseline|Total|Total of all reporting groups
11045540|NCT01280617|FG000|Participant Flow|Thymoglobulin 1.25mg/kg Dose|"The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.~Thymoglobulin: Thymoglobulin 1.25mg/kg dose"
11045541|NCT01280617|FG001|Participant Flow|Thymoglobulin 0.75mg/kg Dose|"The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.~Thymoglobulin 0.75mg/kg dose: Thymoglobulin"
11045542|NCT01280617|OG000|Outcome|Thymoglobulin 1.25mg/kg Dose|Thymoglobulin 1.25mg/kg dose All Cause mortality 0/23
11045543|NCT01280617|OG001|Outcome|Thymoglobulin 0.75mg/kg Dose|Thymoglobulin 0.75mg/kg dose All Cause Mortality 3/20 - 2 with pre-existing cardiac disease, diabetes, and history of smoking
11045544|NCT01280617|EG000|Reported Event|Thymoglobulin 1.25mg/kg Dose|Thymoglobulin 1.25mg/kg dose All Cause mortality 0/23
11045545|NCT01280617|EG001|Reported Event|Thymoglobulin 0.75mg/kg Dose|Thymoglobulin 0.75mg/kg dose All Cause Mortality 3/20 - 2 with pre-existing cardiac disease, diabetes, and history of smoking
11045546|NCT01280656|BG000|Baseline|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045547|NCT01280656|BG001|Baseline|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045548|NCT01280656|BG002|Baseline|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045549|NCT01280656|BG003|Baseline|Total|Total of all reporting groups
11045550|NCT01280656|FG000|Participant Flow|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045551|NCT01280656|FG001|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045552|NCT01280656|FG002|Participant Flow|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045553|NCT01280656|OG000|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045554|NCT01280656|OG001|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045555|NCT01280656|OG002|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
11045556|NCT01280656|EG000|Reported Event|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
11045557|NCT01280656|EG001|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy
11045558|NCT01280656|EG002|Reported Event|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
11045559|NCT01280695|BG000|Baseline|Placebo|Placebo capsule once daily
11045560|NCT01280695|BG001|Baseline|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
11045561|NCT01280695|BG002|Baseline|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
11045562|NCT01280695|BG003|Baseline|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
11045563|NCT01280695|BG004|Baseline|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
11045564|NCT01280695|BG005|Baseline|Total|Total of all reporting groups
11045565|NCT01280695|FG000|Participant Flow|Placebo|Placebo capsule once daily
11045566|NCT01280695|FG001|Participant Flow|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
10887315|NCT00499694|OG000|Outcome|Bevacizumab and Satraplatin|"Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
11045567|NCT01280695|FG002|Participant Flow|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
11045568|NCT01280695|FG003|Participant Flow|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
11045569|NCT01280695|FG004|Participant Flow|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
11045570|NCT01280695|OG000|Outcome|Placebo|Placebo capsule once daily
11045571|NCT01280695|OG001|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
11045572|NCT01280695|OG002|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
11045573|NCT01280695|OG003|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
11045574|NCT01280695|OG004|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
11045575|NCT01280695|EG000|Reported Event|Placebo|Placebo capsule once daily
11045576|NCT01280695|EG001|Reported Event|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
11045577|NCT01280695|EG002|Reported Event|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
11045578|NCT01280695|EG003|Reported Event|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
11045579|NCT01280695|EG004|Reported Event|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
11045580|NCT01280721|BG000|Baseline|Tolvaptan|Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg
11045581|NCT01280721|FG000|Participant Flow|Tolvaptan|Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg
11045582|NCT01280721|OG000|Outcome|Baseline|Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period
11045583|NCT01280721|OG001|Outcome|Month 12|Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period
11045584|NCT01280721|OG002|Outcome|Month 24|Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period
11045585|NCT01280721|OG003|Outcome|Month 36|Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period
11045586|NCT01280721|OG000|Outcome|Baseline|Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period
11045587|NCT01280721|OG001|Outcome|Month 12|Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period
11045588|NCT01280721|OG002|Outcome|Month 24|Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period
11045589|NCT01280721|OG003|Outcome|Month 36|Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period
11045590|NCT01280721|OG000|Outcome|Baselime|Measured values of serum cystatin C concentration during trial period
11045591|NCT01280721|OG001|Outcome|Month 12|Measured values of serum cystatin C concentration during trial period
11045592|NCT01280721|OG002|Outcome|Month 24|Measured values of serum cystatin C concentration during trial period
11045593|NCT01280721|OG003|Outcome|Month 36|Measured values of serum cystatin C concentration during trial period
11045594|NCT01280721|EG000|Reported Event|Tolvaptan|Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg
11045595|NCT01280812|BG000|Baseline|PA Intervention and Maintenance Plus|"3-month physical activity intervention and 6-month maintenance intervention-Plus program~Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary."
11045596|NCT01280812|BG001|Baseline|PA Intervention and Maintenance Regular|"3-month physical activity intervention and 6-month maintenance - Regular program~Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer."
11045597|NCT01280812|BG002|Baseline|Pedometer|"Non-intervention group~Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer."
11045598|NCT01280812|BG003|Baseline|Total|Total of all reporting groups
11045599|NCT01280812|FG000|Participant Flow|PA Intervention and Maintenance Plus|"3-month physical activity intervention and 6-month maintenance intervention-Plus program~Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary."
11045600|NCT01280812|FG001|Participant Flow|PA Intervention and Maintenance Regular|"3-month physical activity intervention and 6-month maintenance - Regular program~Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer."
11045601|NCT01280812|FG002|Participant Flow|Pedometer|"Non-intervention group~Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer."
11045602|NCT01280812|OG000|Outcome|PA Intervention and Maintenance Plus|"3-month physical activity intervention and 6-month maintenance intervention-Plus program~Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary."
11045603|NCT01280812|OG001|Outcome|PA Intervention and Maintenance Regular|"3-month physical activity intervention and 6-month maintenance - Regular program~Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer."
11045604|NCT01280812|OG002|Outcome|Control|"Non-intervention group~Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer."
11045605|NCT01280812|OG002|Outcome|Pedometer|"Non-intervention group~Control (pedometer only): This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer."
11045606|NCT01280812|EG000|Reported Event|PA Intervention and Maintenance Plus|"3-month physical activity intervention and 6-month maintenance intervention-Plus program~Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary."
11045607|NCT01280812|EG001|Reported Event|PA Intervention and Maintenance Regular|"3-month physical activity intervention and 6-month maintenance intervention regular program~Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to stop using the app (activity diary)."
11045608|NCT01280812|EG002|Reported Event|Control|"Non-intervention group~Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer."
11045609|NCT01280903|BG000|Baseline|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
11045610|NCT01280903|BG001|Baseline|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
11045611|NCT01280903|BG002|Baseline|Total|Total of all reporting groups
11045612|NCT01280903|FG000|Participant Flow|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
11045613|NCT01280903|FG001|Participant Flow|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
11045614|NCT01280903|OG000|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
11045615|NCT01280903|OG001|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
11045616|NCT01280903|EG000|Reported Event|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
11045617|NCT01280903|EG001|Reported Event|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
11045618|NCT01280942|BG000|Baseline|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
11066697|NCT01393626|EG002|Reported Event|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
11066698|NCT01393626|EG003|Reported Event|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
11045619|NCT01280942|BG001|Baseline|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
11045620|NCT01280942|BG002|Baseline|Total|Total of all reporting groups
11045621|NCT01280942|FG000|Participant Flow|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
11045622|NCT01280942|FG001|Participant Flow|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
11045623|NCT01280942|OG000|Outcome|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
11045624|NCT01280942|OG001|Outcome|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
11045625|NCT01280942|EG000|Reported Event|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
11045626|NCT01280942|EG001|Reported Event|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
11045627|NCT01280955|BG000|Baseline|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
11045628|NCT01280955|FG000|Participant Flow|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
11045629|NCT01280955|OG000|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
11045630|NCT01280955|OG000|Outcome|Transplant Recipients|"Transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
11045631|NCT01280955|OG000|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
11045632|NCT01280955|EG000|Reported Event|Transplant Recipients|"This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Adverse Events were monitored for 29 transplant recipients"
11045633|NCT01280968|BG000|Baseline|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
11045634|NCT01280968|BG001|Baseline|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
11045635|NCT01280968|BG002|Baseline|Total|Total of all reporting groups
11045636|NCT01280968|FG000|Participant Flow|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
11045637|NCT01280968|FG001|Participant Flow|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
11045638|NCT01280968|OG000|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
11045639|NCT01280968|OG001|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
11045640|NCT01280968|OG002|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
11045641|NCT01280968|EG000|Reported Event|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
11045642|NCT01280968|EG001|Reported Event|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
11045643|NCT01280981|BG000|Baseline|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
11045644|NCT01280981|FG000|Participant Flow|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
11045645|NCT01280981|OG000|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
11045646|NCT01280981|EG000|Reported Event|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
11045647|NCT01281007|BG000|Baseline|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
11045648|NCT01281007|BG001|Baseline|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
11045649|NCT01281007|BG002|Baseline|Total|Total of all reporting groups
10887316|NCT00499694|OG000|Outcome|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
11045650|NCT01281007|FG000|Participant Flow|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
11045651|NCT01281007|FG001|Participant Flow|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
11045652|NCT01281007|OG000|Outcome|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
11045653|NCT01281007|OG001|Outcome|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
11045654|NCT01281007|EG000|Reported Event|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
11045655|NCT01281007|EG001|Reported Event|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
11045656|NCT01281137|BG000|Baseline|Continuous Letrozole Treatment Group|Patients were randomized 1:1 for SOLE and enrolled in 1:3 ratio for SOLE-EST between continuous letrozole (2.5 mg/day orally for 5 years) and intermittent letrozole treatment (2.5 mg/day during 9 months followed by a 3 month interruption in years 1-4 and then 2.5 mg/day during all year 5).
11045657|NCT01281137|BG001|Baseline|Intermittent Letrozole Treatment Group|Patients were randomized 1:1 for SOLE and enrolled in 1:3 ratio for SOLE-EST between continuous letrozole (2.5 mg/day orally for 5 years) and intermittent letrozole treatment (2.5 mg/day during 9 months followed by a 3 month interruption in years 1-4 and then 2.5 mg/day during all year 5).
11045658|NCT01281137|BG002|Baseline|Total|Total of all reporting groups
11045659|NCT01281137|FG000|Participant Flow|Continuous Letrozole Treatment Group|The phase 3 randomized, open-label Study of Letrozole Extension (SOLE) enrolled 4884 postmenopausal women between December 2007 and October 2012. Among them, 104 patients were enrolled in the SOLE Estrogen Substudy (SOLE-EST).Patients were randomized 1:1 for SOLE and enrolled in 1:3 ratio for SOLE-EST between continuous letrozole (2.5 mg/day orally for 5 years) and intermittent letrozole treatment (2.5 mg/day during 9 months followed by a 3 month interruption in years 1-4 and then 2.5 mg/day during all year 5).
11045660|NCT01281137|FG001|Participant Flow|Intermittent Letrozole Treatment Group|The phase 3 randomized, open-label Study of Letrozole Extension (SOLE) enrolled 4884 postmenopausal women between December 2007 and October 2012. Among them, 104 patients were enrolled in the SOLE Estrogen Substudy (SOLE-EST).Patients were randomized 1:1 for SOLE and enrolled in 1:3 ratio for SOLE-EST between continuous letrozole (2.5 mg/day orally for 5 years) and intermittent letrozole treatment (2.5 mg/day during 9 months followed by a 3 month interruption in years 1-4 and then 2.5 mg/day during all year 5).
11045661|NCT01281137|OG000|Outcome|Continuous Letrozole Treatment Group (Baseline, Month 0)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045662|NCT01281137|OG001|Outcome|Intermittent Letrozole Treatment Group (Baseline, Month 0)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045663|NCT01281137|OG002|Outcome|Continuous Letrozole Treatment Group (9 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045664|NCT01281137|OG003|Outcome|Intermittent Letrozole Treatment Group (9 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045665|NCT01281137|OG004|Outcome|Continuous Letrozole Treatment Group (10.5 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045666|NCT01281137|OG005|Outcome|Intermittent Letrozole Treatment Group (10.5 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045667|NCT01281137|OG006|Outcome|Continuous Letrozole Treatment Group (12 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045668|NCT01281137|OG007|Outcome|Intermittent Letrozole Treatment Group (12 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045669|NCT01281137|OG000|Outcome|Continuous Letrozole Treamtnet Group (9 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent)/, 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045670|NCT01281137|OG001|Outcome|Intermittent Letrozole Treatment Group (9 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045671|NCT01281137|OG002|Outcome|Continuous Letrozole Treatment Arm (10.5 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045672|NCT01281137|OG003|Outcome|Intermittent Letrozole Treatment Group (10.5 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045673|NCT01281137|OG004|Outcome|Continuous Letrozole Treatment Arm (12 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045674|NCT01281137|OG005|Outcome|Intermittent Letrozole Treatment Group (12 Months)|There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent), and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in analyses of hormone levels over time.
11045675|NCT01281137|OG000|Outcome|Continuous Letrozole Treatment Group|In total, 76/85 patients (19 continuous; 57 intermittent) who had a 9 month sample also had a sample at 12 months and are included in analyses relating E2 change (9 to 12m) with QL, grip strength and AE changes.
11045676|NCT01281137|OG001|Outcome|Intermittent Letrozole Treatment Group|In total, 76/85 patients (19 continuous; 57 intermittent) who had a 9 month sample also had a sample at 12 months and are included in analyses relating E2 change (9 to 12m) with QL, grip strength and AE changes.
11045677|NCT01281137|OG000|Outcome|Continuous Letrozole Treatment Group|In total, 76/85 patients (19 continuous; 57 intermittent) who had a 6 month sample also had a sample at 12 months and are included in analyses relating E2 change with quality of life.
11045678|NCT01281137|OG001|Outcome|Intermittent Letrozole Treatment Group|In total, 76/85 patients (19 continuous; 57 intermittent) who had a 6 month sample also had a sample at 12 months and are included in analyses relating E2 change with quality of life.
11045679|NCT01281137|OG000|Outcome|Continuous Letrozole Treatment Group|Longitudinal analysis population N=90 (21 Continuous letrozole; 69 Intermittent letrozole); N samples per timepoint: N=90 at baseline, N=85 at month 9; N= 84 at month 10.5, N=81 at month 12. In total, 76/85 patients (19 continuous; 57 intermittent) who had a 9 month sample also had a sample at 12 months and are included in analyses relating E2 change (9 to 12m) with QL, grip strength and AE changes.
11066699|NCT01393704|BG000|Baseline|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
11045680|NCT01281137|OG001|Outcome|Intermittent Letrozole Treatment Group|Longitudinal analysis population N=90 (21 Continuous letrozole; 69 Intermittent letrozole); N samples per timepoint: N=90 at baseline, N=85 at month 9; N= 84 at month 10.5, N=81 at month 12. In total, 76/85 patients (19 continuous; 57 intermittent) who had a 9 month sample also had a sample at 12 months and are included in analyses relating E2 change (9 to 12m) with QL, grip strength and AE changes.
11045681|NCT01281137|EG000|Reported Event|Continuous Letrozole Treatment Group|Patients were randomized 1:1 for SOLE and enrolled in 1:3 ratio for SOLE-EST between continuous letrozole (2.5 mg/day orally for 5 years) and intermittent letrozole treatment (2.5 mg/day during 9 months followed by a 3 month interruption in years 1-4 and then 2.5 mg/day during all year 5).
11045682|NCT01281137|EG001|Reported Event|Intermittent Letrozole Treatment Group|Patients were randomized 1:1 for SOLE and enrolled in 1:3 ratio for SOLE-EST between continuous letrozole (2.5 mg/day orally for 5 years) and intermittent letrozole treatment (2.5 mg/day during 9 months followed by a 3 month interruption in years 1-4 and then 2.5 mg/day during all year 5).
11045683|NCT01281189|BG000|Baseline|Placebo|Matching Placebo: Oral tablet twice daily.
11045684|NCT01281189|BG001|Baseline|Dexpramipexole|Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
11045685|NCT01281189|BG002|Baseline|Total|Total of all reporting groups
11045686|NCT01281189|FG000|Participant Flow|Placebo|Matching Placebo: Oral tablet twice daily.
11045687|NCT01281189|FG001|Participant Flow|Dexpramipexole|Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
11045688|NCT01281189|OG000|Outcome|Placebo|Matching Placebo: Oral tablet twice daily.
11045689|NCT01281189|OG001|Outcome|Dexpramipexole|Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
11045690|NCT01281189|EG000|Reported Event|Placebo|Matching Placebo: Oral tablet twice daily.
11045691|NCT01281189|EG001|Reported Event|Dexpramipexole|Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
10887272|NCT00499603|EG000|Reported Event|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
11045692|NCT01281202|BG000|Baseline|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
11045693|NCT01281202|BG001|Baseline|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
11045694|NCT01281202|BG002|Baseline|Total|Total of all reporting groups
11045695|NCT01281202|FG000|Participant Flow|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
11045696|NCT01281202|FG001|Participant Flow|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
11045697|NCT01281202|OG000|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
11045698|NCT01281202|OG001|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
11045699|NCT01281202|OG000|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase~During treatment, subject received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
11045700|NCT01281202|OG001|Outcome|Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase~During treatment, subject received Vigabatrin matching placebo tablets, bid, for 9 weeks~Subject were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
11045701|NCT01281202|EG000|Reported Event|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
11045702|NCT01281202|EG001|Reported Event|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
11045703|NCT01281306|BG000|Baseline|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
11045704|NCT01281306|BG001|Baseline|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
11045705|NCT01281306|BG002|Baseline|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
11045706|NCT01281306|BG003|Baseline|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
11045707|NCT01281306|BG004|Baseline|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
11045708|NCT01281306|BG005|Baseline|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
11045709|NCT01281306|BG006|Baseline|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
11045710|NCT01281306|BG007|Baseline|Total|Total of all reporting groups
11045711|NCT01281306|FG000|Participant Flow|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
11045712|NCT01281306|FG001|Participant Flow|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
11045713|NCT01281306|FG002|Participant Flow|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
11045714|NCT01281306|FG003|Participant Flow|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
11045715|NCT01281306|FG004|Participant Flow|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
11226350|NCT02374138|OG000|Outcome|Intervention|"Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.~Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by community wellness coaches."
11226351|NCT02374138|EG000|Reported Event|Usual Care|"IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination~Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination"
11045716|NCT01281306|FG005|Participant Flow|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
11045717|NCT01281306|FG006|Participant Flow|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
11045718|NCT01281306|OG000|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
11045719|NCT01281306|OG001|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
11045720|NCT01281306|OG002|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
11045721|NCT01281306|OG003|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
11045722|NCT01281306|OG004|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
11045723|NCT01281306|OG005|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
11045724|NCT01281306|OG006|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
11045725|NCT01281306|EG000|Reported Event|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
11045726|NCT01281306|EG001|Reported Event|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
11045727|NCT01281306|EG002|Reported Event|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
11045728|NCT01281306|EG003|Reported Event|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
11045729|NCT01281306|EG004|Reported Event|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
11045730|NCT01281306|EG005|Reported Event|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
11045731|NCT01281306|EG006|Reported Event|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
11045732|NCT01281475|BG000|Baseline|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
11045733|NCT01281475|BG001|Baseline|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.~It is also taken 3 times a day, just like Levodopa."
11045734|NCT01281475|BG002|Baseline|Total|Total of all reporting groups
11045735|NCT01281475|FG000|Participant Flow|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
11226352|NCT02374138|EG001|Reported Event|Intervention|"Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.~Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by community wellness coaches."
11045736|NCT01281475|FG001|Participant Flow|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
11045737|NCT01281475|OG000|Outcome|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
11045738|NCT01281475|OG001|Outcome|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.~The placebo capsules are taken 3 times a day, just like the levodopa / carbidopa capsules"
11045739|NCT01281475|OG000|Outcome|Levodopa|"Levodopa is prescribed as a combination of levodopa/carbidopa (4:1) to reduce the peripheral side effects. The dosage used was 15 mg/kg/day in 3 divided doses.~Levodopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
11045740|NCT01281475|OG001|Outcome|Placebo|"The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa, so it is not expected to have any effect.~Placebo Oral Capsule: The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa."
11045741|NCT01281475|EG000|Reported Event|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
11045742|NCT01281475|EG001|Reported Event|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
11045743|NCT01281501|BG000|Baseline|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
11045744|NCT01281501|BG001|Baseline|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
11045745|NCT01281501|BG002|Baseline|Total|Total of all reporting groups
10887317|NCT00499694|EG000|Reported Event|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
11045746|NCT01281501|FG000|Participant Flow|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
11045747|NCT01281501|FG001|Participant Flow|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
11045748|NCT01281501|OG000|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
11045749|NCT01281501|OG001|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
11045750|NCT01281501|EG000|Reported Event|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
11045751|NCT01281501|EG001|Reported Event|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
11045752|NCT01281839|BG000|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11045753|NCT01281839|BG001|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
11045754|NCT01281839|BG002|Baseline|Total|Total of all reporting groups
11045755|NCT01281839|FG000|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11045756|NCT01281839|FG001|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
11045757|NCT01281839|OG000|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11045758|NCT01281839|OG001|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
11045759|NCT01281839|EG000|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11045760|NCT01281839|EG001|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
11045761|NCT01281865|BG000|Baseline|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
11045762|NCT01281865|BG001|Baseline|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
11045763|NCT01281865|BG002|Baseline|Total|Total of all reporting groups
11045764|NCT01281865|FG000|Participant Flow|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
11045765|NCT01281865|FG001|Participant Flow|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
11045766|NCT01281865|OG000|Outcome|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
11045767|NCT01281865|OG001|Outcome|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
11045768|NCT01281865|EG000|Reported Event|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
11045769|NCT01281865|EG001|Reported Event|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
11045770|NCT01281917|BG000|Baseline|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
11045771|NCT01281917|FG000|Participant Flow|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
11045772|NCT01281917|OG000|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
11045773|NCT01281917|EG000|Reported Event|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
11045774|NCT01281956|BG000|Baseline|All Participants Enrolled in Study|All participants enrolled in the study
11045775|NCT01281956|FG000|Participant Flow|Placebo Then PRX|Participants with epilepsy receiving placebo during the first period followed by PRX during the second period
11045776|NCT01281956|FG001|Participant Flow|PRX Then Placebo|Participants with epilepsy receiving PRX during the first period followed by Placebo during the second period
11226353|NCT02374164|BG000|Baseline|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
11045777|NCT01281956|OG000|Outcome|PRX-0023|Participants with epilepsy receiving PRX-0023
11045778|NCT01281956|OG001|Outcome|Placebo|Participants with epilepsy receiving Placebo
11045779|NCT01281956|OG000|Outcome|All Participants Who Completed Study|All participants who completed both arms of the study
11045780|NCT01281956|OG001|Outcome|Placebo|Participants with epilepsy receiving placebo
11045781|NCT01281956|OG000|Outcome|PRX-0023|Participants with epilepsy receiving PRX
11045782|NCT01281956|EG000|Reported Event|PRX-0023|Participants with epilepsy receiving PRX-0023
11045783|NCT01281956|EG001|Reported Event|Placebo|Participants with epilepsy receiving placebo
11045784|NCT01281969|BG000|Baseline|IVIG|Gamunex Intravenous Immunoglobulin: 2.0 gm/kg total, IV (in the vein), over 2 days
11045785|NCT01281969|BG001|Baseline|Placebo|Placebo: Normal saline, IV (in the vein), over 2 days
11045786|NCT01281969|BG002|Baseline|Total|Total of all reporting groups
11045787|NCT01281969|FG000|Participant Flow|IVIG|Gamunex Intravenous Immunoglobulin: 2.0 gm/kg total, IV (in the vein), over 2 days
11045788|NCT01281969|FG001|Participant Flow|Placebo|Placebo: Normal saline, IV (in the vein), over 2 days
11045789|NCT01281969|FG002|Participant Flow|Screened But Not Randomized|Excluded prior to randomization because child did not meet study entry criteria or child refused consent
11045790|NCT01281969|OG000|Outcome|Group A|Gamunex Intravenous Immunoglobulin: 2.0 gm/kg total, IV (in the vein), over 2 days
11045791|NCT01281969|OG001|Outcome|Group B|Placebo: Normal saline, IV (in the vein), over 2 days
11045792|NCT01281969|OG000|Outcome|IVIG|Gamunex Intravenous Immunoglobulin: 2.0 gm/kg total, IV (in the vein), over 2 days
11045793|NCT01281969|OG001|Outcome|Placebo|Placebo: Normal saline, IV (in the vein), over 2 days
11045794|NCT01281969|EG000|Reported Event|Group A|Gamunex Intravenous Immunoglobulin: 2.0 gm/kg total, IV (in the vein), over 2 days
11045795|NCT01281969|EG001|Reported Event|Group B|Placebo: Normal saline, IV (in the vein), over 2 days
11045796|NCT01282086|BG000|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
11045797|NCT01282086|FG000|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
11045798|NCT01282086|OG000|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
11045799|NCT01282086|OG000|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery.
11045800|NCT01282086|EG000|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
11045801|NCT01282138|BG000|Baseline|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
11045802|NCT01282138|BG001|Baseline|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
11045803|NCT01282138|BG002|Baseline|Total|Total of all reporting groups
11045804|NCT01282138|FG000|Participant Flow|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
11045805|NCT01282138|FG001|Participant Flow|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
11045806|NCT01282138|OG000|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
11045807|NCT01282138|OG001|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
11045808|NCT01282138|EG000|Reported Event|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
11045809|NCT01282138|EG001|Reported Event|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
11045810|NCT01282164|BG000|Baseline|Study Patients|"patients with growth hormone deficiency or hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
11045811|NCT01282164|BG001|Baseline|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
11045812|NCT01282164|BG002|Baseline|Total|Total of all reporting groups
11045813|NCT01282164|FG000|Participant Flow|Study Patients|"patients with growth hormone deficiency or hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg adrenocorticotropin hormone (ACTH) stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), cerebrovascular disease (CVD), seizure"
11045814|NCT01282164|FG001|Participant Flow|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
11045815|NCT01282164|OG000|Outcome|Patients With 1-2 PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
11045816|NCT01282164|OG001|Outcome|Patients With 1-2 PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
10887318|NCT00499746|BG000|Baseline|Group 1|
11045817|NCT01282164|OG002|Outcome|Patients With 1-2 PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
11045818|NCT01282164|OG000|Outcome|Control Group- ITT|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site did not enroll the control group. All underwent insulin tolerance test using 0.10-0.15 U/kg
11045819|NCT01282164|OG001|Outcome|Control Group- Fixed-dose GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
11045820|NCT01282164|OG002|Outcome|Control Group- Weight-based GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
11045821|NCT01282164|OG000|Outcome|Patients With 3 or More PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
11045822|NCT01282164|OG001|Outcome|Patients With 3 or More PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
11045823|NCT01282164|OG002|Outcome|Patients With 3 or More PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
11045824|NCT01282164|OG000|Outcome|Patients Older Than 65|Three patients with adult onset hypothalamic-pituitary disease underwent who were older than 65 years of age underwent ACTH stimulation test instead of ITT.
11045825|NCT01282164|EG000|Reported Event|Study Patients|"patients with hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
11045826|NCT01282164|EG001|Reported Event|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
11045827|NCT01282203|BG000|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
11045828|NCT01282203|FG000|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
11045829|NCT01282203|OG000|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
11045830|NCT01282203|OG000|Outcome|General Anesthesia|Duration of experience with general anesthesia.
11045831|NCT01282203|OG001|Outcome|Inhalation Anesthesia|Duration of experience with inhalation anesthesia.
11045832|NCT01282203|OG002|Outcome|Anesthesia With Sevorane|Duration of experience with Sevorane.
11045833|NCT01282203|EG000|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
11045834|NCT01282229|BG000|Baseline|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
11045835|NCT01282229|FG000|Participant Flow|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
11045836|NCT01282229|OG000|Outcome|LANAP Quadrant (5-6mm Pockets)|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
11045837|NCT01282229|OG001|Outcome|LANAP Quadrant (≥7mm Pockets)|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
11045838|NCT01282229|OG002|Outcome|Modified Widman Flap (5-6mm Pockets)|Quadrant treated with Modified Widman Flap surgery
11045839|NCT01282229|OG003|Outcome|Modified Widman Flap (≥7mm Pockets)|Quadrant treated with Modified Widman Flap surgery
11045840|NCT01282229|OG004|Outcome|Scaling and Root Planing (5-6mm Pockets)|Quadrant treated with scaling and root planing alone
11045841|NCT01282229|OG005|Outcome|Scaling and Root Planing (≥7mm Pockets)|Quadrant treated with scaling and root planing alone
11045842|NCT01282229|OG006|Outcome|Coronal Debridement (5-6mm Pockets)|Quadrant treated with coronal debridement
11045843|NCT01282229|OG007|Outcome|Coronal Debridement (≥7mm Pockets)|Quadrant treated with coronal debridement
11045844|NCT01282229|OG000|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
11045845|NCT01282229|OG001|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
11045846|NCT01282229|OG002|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
11045847|NCT01282229|OG003|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
11045848|NCT01282229|EG000|Reported Event|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
11045849|NCT01282229|EG001|Reported Event|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
11045850|NCT01282229|EG002|Reported Event|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
11045851|NCT01282229|EG003|Reported Event|Coronal Debridement|Quadrant treated with coronal debridement
11045852|NCT01282242|BG000|Baseline|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
11045853|NCT01282242|BG001|Baseline|SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
11045854|NCT01282242|BG002|Baseline|Total|Total of all reporting groups
11045855|NCT01282242|FG000|Participant Flow|Primary SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
11045856|NCT01282242|FG001|Participant Flow|Secondary SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
11045857|NCT01282242|OG000|Outcome|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
11045858|NCT01282242|OG001|Outcome|SIR < 1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
11045859|NCT01282242|EG000|Reported Event|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
11045860|NCT01282242|EG001|Reported Event|SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
11045861|NCT01282294|BG000|Baseline|ETN PROtect|"There is only 1 cohort in this case series.~ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating"
11045862|NCT01282294|FG000|Participant Flow|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
11045863|NCT01282294|OG000|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
11045864|NCT01282294|EG000|Reported Event|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
11045865|NCT01282372|BG000|Baseline|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
11045866|NCT01282372|FG000|Participant Flow|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
11045867|NCT01282372|OG000|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
11045868|NCT01282372|OG001|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
11045869|NCT01282372|OG002|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
11045870|NCT01282372|OG000|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
11045871|NCT01282372|OG000|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
11045872|NCT01282372|OG000|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
11045873|NCT01282372|OG000|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
11045874|NCT01282372|OG000|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
11045875|NCT01282372|EG000|Reported Event|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
11045876|NCT01282424|BG000|Baseline|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
11045877|NCT01282424|FG000|Participant Flow|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
11045878|NCT01282424|OG000|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
11045879|NCT01282424|EG000|Reported Event|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
11045880|NCT01282463|BG000|Baseline|Docetaxel|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle"
11045881|NCT01282463|BG001|Baseline|Docetaxel + Ramucirumab DP|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle"
11045882|NCT01282463|BG002|Baseline|Docetaxel + Icrucumab|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle"
11045883|NCT01282463|BG003|Baseline|Total|Total of all reporting groups
11045884|NCT01282463|FG000|Participant Flow|Docetaxel|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle"
11045885|NCT01282463|FG001|Participant Flow|Docetaxel + Ramucirumab DP|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle"
11045886|NCT01282463|FG002|Participant Flow|Docetaxel + Icrucumab|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle"
11045887|NCT01282463|OG000|Outcome|Docetaxel|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle"
11045888|NCT01282463|OG001|Outcome|Docetaxel + Ramucirumab DP|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle"
11045889|NCT01282463|OG002|Outcome|Docetaxel + Icrucumab|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle"
11045890|NCT01282463|OG000|Outcome|Docetaxel|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle"
11045891|NCT01282463|OG000|Outcome|Docetaxel + Ramucirumab DP|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle"
11045892|NCT01282463|OG000|Outcome|Docetaxel + Icrucumab|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Icrucumab: 12 mg/kg IV on Day 1 and Day 8 of each 21-day cycle"
11045893|NCT01282463|OG000|Outcome|Docetaxel + Icrucumab|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle"
11045894|NCT01282463|OG000|Outcome|Docetaxel + Icrucumab|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle"
11045895|NCT01282463|OG001|Outcome|Docetaxel + Ramucirumab DP|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle"
11045896|NCT01282463|OG002|Outcome|Docetaxel + Icrucumab|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle"
11045897|NCT01282463|OG000|Outcome|Docetaxel|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle"
11045898|NCT01282463|EG000|Reported Event|Docetaxel|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle"
11045899|NCT01282463|EG001|Reported Event|Docetaxel + Ramucirumab DP|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle"
11045900|NCT01282463|EG002|Reported Event|Docetaxel + Icrucumab|"Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.~Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle~Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle"
11045901|NCT01282476|BG000|Baseline|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
11045902|NCT01282476|FG000|Participant Flow|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
11045903|NCT01282476|OG000|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
11045904|NCT01282476|EG000|Reported Event|Panobinostat/Rituximab|"single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.~Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles."
11226354|NCT02374164|BG001|Baseline|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
11045905|NCT01282710|BG000|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
11226355|NCT02374164|BG002|Baseline|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
11045906|NCT01282710|FG000|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
11045907|NCT01282710|OG000|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
11045908|NCT01282710|EG000|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
11045909|NCT01282723|BG000|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
11045910|NCT01282723|FG000|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
11045911|NCT01282723|OG000|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
11045912|NCT01282723|EG000|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
11045913|NCT01282801|BG000|Baseline|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11045914|NCT01282801|BG001|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11045915|NCT01282801|BG002|Baseline|Total|Total of all reporting groups
11045916|NCT01282801|FG000|Participant Flow|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11045917|NCT01282801|FG001|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11045918|NCT01282801|OG000|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
11045919|NCT01282801|OG001|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
11045920|NCT01282801|EG000|Reported Event|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11045921|NCT01282801|EG001|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11045922|NCT01282814|BG000|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11045923|NCT01282814|BG001|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11045924|NCT01282814|BG002|Baseline|Total|Total of all reporting groups
11045925|NCT01282814|FG000|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11045926|NCT01282814|FG001|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11045927|NCT01282814|OG000|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
11045928|NCT01282814|OG001|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
11045929|NCT01282814|EG000|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
11045930|NCT01282814|EG001|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
11045931|NCT01282866|BG000|Baseline|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
11045932|NCT01282866|FG000|Participant Flow|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
11045933|NCT01282866|OG000|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
11045934|NCT01282866|EG000|Reported Event|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
11045935|NCT01283009|BG000|Baseline|Arm 1: Inactive Substance|"Inactive substance~Inactive substance will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day)."
11045936|NCT01283009|BG001|Baseline|Arm 2: Methylprednisolone|"Methylprednisolone~Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day)."
11045937|NCT01283009|BG002|Baseline|Total|Total of all reporting groups
11045938|NCT01283009|FG000|Participant Flow|Arm 1: Inactive Substance|"Inactive substance~Inactive Substance: Inactive Substance will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day)."
11045939|NCT01283009|FG001|Participant Flow|Arm 2: Methylprednisolone|"Methylprednisolone~Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day)."
11045940|NCT01283009|OG000|Outcome|Arm 1: Inactive Substance|"Inactive substance~Inactive substance will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day)."
11045941|NCT01283009|OG001|Outcome|Arm 2: Methylprednisolone|"Methylprednisolone~Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day)."
11045942|NCT01283009|EG000|Reported Event|Arm 1: Inactive Substance|"Inactive substance~Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day)."
11045943|NCT01283009|EG001|Reported Event|Arm 2: Methylprednisolone|"Methylprednisolone~Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day)."
11045944|NCT01283022|BG000|Baseline|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
11045945|NCT01283022|FG000|Participant Flow|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
11045946|NCT01283022|OG000|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
11045947|NCT01283022|OG000|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
11045948|NCT01283022|EG000|Reported Event|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
11045949|NCT01283035|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11226356|NCT02374164|BG003|Baseline|Total|Total of all reporting groups
11045950|NCT01283035|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11045951|NCT01283035|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11045952|NCT01283035|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10887319|NCT00499746|FG000|Participant Flow|All Participants|Participant flow is reported in single group due to the number of randomized sequences. In Phase 1 and Phase 2, each participant received two exposures of each training drug in randomize order (placebo, Hydromorphone 8 mg, Methylphenidate 60 mg). In Phase 3, each participant received randomized exposure to placebo, Hydromorphone (4 and 8 mg), Methylphenidate (30 and 60 mg), tramadol (50, 100, 200, and 400 mg).
11045953|NCT01283139|BG000|Baseline|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045954|NCT01283139|BG001|Baseline|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045955|NCT01283139|BG002|Baseline|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045956|NCT01283139|BG003|Baseline|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045957|NCT01283139|BG004|Baseline|Total|Total of all reporting groups
11045958|NCT01283139|FG000|Participant Flow|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045959|NCT01283139|FG001|Participant Flow|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045960|NCT01283139|FG002|Participant Flow|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045961|NCT01283139|FG003|Participant Flow|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045962|NCT01283139|OG000|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
10887320|NCT00499746|OG000|Outcome|Placebo 0 mg|
11045963|NCT01283139|OG001|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045964|NCT01283139|OG002|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045965|NCT01283139|OG003|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
11045966|NCT01283139|EG000|Reported Event|Placebo|Placebo matching to sifalimumab administered intravenously for 48 weeks (Day 337).
11045967|NCT01283139|EG001|Reported Event|Sifalimumab 200 mg|Sifalimumab 200 milligram (mg) administered intravenously for 48 weeks (Day 337).
11045968|NCT01283139|EG002|Reported Event|Sifalimumab 600 mg|Sifalimumab 600 mg administered intravenously for 48 weeks (Day 337).
11045969|NCT01283139|EG003|Reported Event|Sifalimumab 1200 mg|Sifalimumab 1,200 mg administered intravenously for 48 weeks (Day 337).
11045970|NCT01283152|BG000|Baseline|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
11045971|NCT01283152|BG001|Baseline|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
11045972|NCT01283152|BG002|Baseline|Total|Total of all reporting groups
11045973|NCT01283152|FG000|Participant Flow|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
11045974|NCT01283152|FG001|Participant Flow|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
11045975|NCT01283152|OG000|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
11045976|NCT01283152|OG001|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
11045977|NCT01283152|EG000|Reported Event|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
11045978|NCT01283152|EG001|Reported Event|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
11045979|NCT01283282|BG000|Baseline|All Subjects|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
11045980|NCT01283282|FG000|Participant Flow|Placebo First/Then Clopidogrel|The subjects received placebo PO qd for the first 6 weeks then were switched to clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
11045981|NCT01283282|FG001|Participant Flow|Clopidogrel First/Then Placebo|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks then were switched to placebo PO qd therapy for an additional 6 weeks without any wash out period in between.
11045982|NCT01283282|OG000|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
11045983|NCT01283282|OG001|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
11045984|NCT01283282|OG000|Outcome|Clopidogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
11226357|NCT02374164|FG000|Participant Flow|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
11045985|NCT01283282|EG000|Reported Event|Clopidogrel|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
11045986|NCT01283282|EG001|Reported Event|Placebo|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
11045987|NCT01283321|BG000|Baseline|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
11045988|NCT01283321|BG001|Baseline|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
11045989|NCT01283321|BG002|Baseline|Total|Total of all reporting groups
10887321|NCT00499746|OG001|Outcome|Hydromorphone 8 mg|
10887322|NCT00499746|OG002|Outcome|Methylphenidate 60 mg|
10887323|NCT00499746|OG001|Outcome|Hydromorphone 4 mg|
11045990|NCT01283321|FG000|Participant Flow|Group A: RiaSTAP|Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
11045991|NCT01283321|FG001|Participant Flow|Group B: Apheresis Platelets|apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
11045992|NCT01283321|OG000|Outcome|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
11045993|NCT01283321|OG001|Outcome|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
11045994|NCT01283321|OG000|Outcome|Group A: RiaSTAP|Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
11045995|NCT01283321|OG001|Outcome|Group B: Apheresis Platelets|apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
11045996|NCT01283321|EG000|Reported Event|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
11045997|NCT01283321|EG001|Reported Event|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
11045998|NCT01283334|BG000|Baseline|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
11045999|NCT01283334|FG000|Participant Flow|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
11046000|NCT01283334|OG000|Outcome|Everolimus Dose Level 1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level 1 (2.5 mg/day)
11046001|NCT01283334|OG001|Outcome|Everolimus Dose Level -1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level -1 (2.5 mg every other day)
11046002|NCT01283334|OG000|Outcome|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
11046003|NCT01283334|EG000|Reported Event|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
11066700|NCT01393704|BG001|Baseline|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
11066701|NCT01393704|BG002|Baseline|Total|Total of all reporting groups
11046004|NCT01283386|BG000|Baseline|FCR-lite|Rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m^2 IV on Days 1-3; cyclophosphamide 150 mg/m^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m^2 orally on Days 1-3; cyclophosphamide 150 mg/m^2 orally on Days 1-3 for 6 cycles (28 days each).
11046005|NCT01283386|BG001|Baseline|LR Therapy|Rituximab 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m^2 orally on Days 1-7 for 6 cycles.
11046006|NCT01283386|BG002|Baseline|Total|Total of all reporting groups
11046007|NCT01283386|FG000|Participant Flow|FCR-lite|Rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m^2 IV on Days 1-3; cyclophosphamide 150 mg/m^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m^2 orally on Days 1-3; cyclophosphamide 150 mg/m^2 orally on Days 1-3 for 6 cycles (28 days each).
11046008|NCT01283386|FG001|Participant Flow|LR Therapy|Rituximab 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m^2 orally on Days 1-7 for 6 cycles.
11046009|NCT01283386|OG000|Outcome|FCR-lite|Rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m^2 IV on Days 1-3; cyclophosphamide 150 mg/m^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m^2 orally on Days 1-3; cyclophosphamide 150 mg/m^2 orally on Days 1-3 for 6 cycles (28 days each).
11046010|NCT01283386|OG001|Outcome|LR Therapy|Rituximab 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m^2 orally on Days 1-7 for 6 cycles.
11046011|NCT01283386|EG000|Reported Event|FCR-lite|Rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m^2 IV on Days 1-3; cyclophosphamide 150 mg/m^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m^2 orally on Days 1-3; cyclophosphamide 150 mg/m^2 orally on Days 1-3 for 6 cycles (28 days each).
11046012|NCT01283386|EG001|Reported Event|LR Therapy|Rituximab 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m^2 orally on Days 1-7 for 6 cycles.
11046013|NCT01283464|BG000|Baseline|Retinol|Retinol 1.0% cream
11226358|NCT02374164|FG001|Participant Flow|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
10887324|NCT00499746|OG002|Outcome|Hydromorphone 8 mg|
11046014|NCT01283464|BG001|Baseline|Tretinoin|Tretinoin 0.02% cream
11046015|NCT01283464|BG002|Baseline|Total|Total of all reporting groups
11046016|NCT01283464|FG000|Participant Flow|Retinol|Retinol 1.0% cream to entire face daily or as tolerated for 6 months
11046017|NCT01283464|FG001|Participant Flow|Tretinoin|Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months
11046018|NCT01283464|OG000|Outcome|Retinol|Retinol 1.0% cream
11046019|NCT01283464|OG001|Outcome|Tretinoin|Tretinoin 0.02% cream
11046020|NCT01283464|EG000|Reported Event|Retinol|Retinol 1.0% cream
11046021|NCT01283464|EG001|Reported Event|Tretinoin|Tretinoin 0.02% cream
11046022|NCT01283516|BG000|Baseline|LDK378 50 mg|Participants receiving 50 mg of LDK378
11046023|NCT01283516|BG001|Baseline|LDK378 100 mg|Participants receiving 100 mg of LDK378
11046024|NCT01283516|BG002|Baseline|LDK378 200 mg|Participants receiving 200 mg of LDK378
10887325|NCT00499746|OG003|Outcome|Methylphenidate 30 mg|
10887326|NCT00499746|OG004|Outcome|Methylphenidate 60 mg|
10887327|NCT00499746|OG005|Outcome|Tramadol 50 mg|
10887328|NCT00499746|OG006|Outcome|Tramadol 100 mg|
10887329|NCT00499746|OG007|Outcome|Tramadol 200 mg|
11046025|NCT01283516|BG003|Baseline|LDK378 300 mg|Participants receiving 300 mg of LDK378
11046026|NCT01283516|BG004|Baseline|LDK378 400 mg|Participants receiving 400 mg of LDK378
11046027|NCT01283516|BG005|Baseline|LDK378 500 mg|Participants receiving 500 mg of LDK378
11046028|NCT01283516|BG006|Baseline|LDK378 600 mg|Participants receiving 600 mg of LDK378
11046029|NCT01283516|BG007|Baseline|LDK378 700 mg|Participants receiving 700 mg of LDK378
11046030|NCT01283516|BG008|Baseline|LDK378 750 mg|Participants receiving 750 mg of LDK378.
11046031|NCT01283516|BG009|Baseline|Total|Total of all reporting groups
11046032|NCT01283516|FG000|Participant Flow|LDK378 50 mg|Participants receiving 50 mg of LDK378
11046033|NCT01283516|FG001|Participant Flow|LDK378 100 mg|Participants receiving 100 mg of LDK378
11046034|NCT01283516|FG002|Participant Flow|LDK378 200 mg|Participants receiving 200 mg of LDK378
11046035|NCT01283516|FG003|Participant Flow|LDK378 300 mg|Participants receiving 300 mg of LDK378
11046036|NCT01283516|FG004|Participant Flow|LDK378 400 mg|Participants receiving 400 mg of LDK378
11046037|NCT01283516|FG005|Participant Flow|LDK378 500 mg|Participants receiving 500 mg of LDK378
11046038|NCT01283516|FG006|Participant Flow|LDK378 600 mg|Participants receiving 600 mg of LDK378
11046039|NCT01283516|FG007|Participant Flow|LDK378 700 mg|Participants receiving 700 mg of LDK378
11046040|NCT01283516|FG008|Participant Flow|LDK378 750 mg|Participants receiving 750 mg of LDK378.
11046041|NCT01283516|OG000|Outcome|LDK378 50 mg|Participants receiving 50 mg of LDK378
11046042|NCT01283516|OG001|Outcome|LDK378 100 mg|Participants receiving 100 mg of LDK378
11046043|NCT01283516|OG002|Outcome|LDK378 200 mg|Participants receiving 200 mg of LDK378
11046044|NCT01283516|OG003|Outcome|LDK378 300 mg|Participants receiving 300 mg of LDK378
11046045|NCT01283516|OG004|Outcome|LDK378 400 mg|Participants receiving 400 mg of LDK378
11046046|NCT01283516|OG005|Outcome|LDK378 500 mg|Participants receiving 500 mg of LDK378
11046047|NCT01283516|OG006|Outcome|LDK378 600 mg|Participants receiving 600 mg of LDK378
11046048|NCT01283516|OG007|Outcome|LDK378 700 mg|Participants receiving 700 mg of LDK378
11046049|NCT01283516|OG008|Outcome|LDK378 750 mg|Participants receiving 750 mg of LDK378.
11046050|NCT01283516|OG000|Outcome|NSCLC With Prior ALKi (Arms 1A + 1B)|Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
11046051|NCT01283516|OG001|Outcome|NSCLC ALKi Naive (Arm 2)|Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
11046052|NCT01283516|OG002|Outcome|All NSCLC|all NSCLC patients.
11046053|NCT01283516|OG002|Outcome|All NCSLC|all NSCLC patients.
11046054|NCT01283516|OG002|Outcome|All NSCLC|all NSCLC patients
11046055|NCT01283516|OG001|Outcome|NSCLC ALKi Naive (Arm 2)|Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor
10887273|NCT00499603|EG001|Reported Event|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
11046056|NCT01283516|OG002|Outcome|ALL NSCLC|all NSCLC patients.
11046057|NCT01283516|EG000|Reported Event|LDK378 50 mg|Participants receiving 50 mg of LDK378
11046058|NCT01283516|EG001|Reported Event|LDK378 100 mg|Participants receiving 100 mg of LDK378
11046059|NCT01283516|EG002|Reported Event|LDK378 200 mg|Participants receiving 200 mg of LDK378
11046060|NCT01283516|EG003|Reported Event|LDK378 300 mg|Participants receiving 300 mg of LDK378
11046061|NCT01283516|EG004|Reported Event|LDK378 400 mg|Participants receiving 400 mg of LDK378
11046062|NCT01283516|EG005|Reported Event|LDK378 500 mg|Participants receiving 500 mg of LDK378
11046063|NCT01283516|EG006|Reported Event|LDK378 600 mg|Participants receiving 600 mg of LDK378
11046064|NCT01283516|EG007|Reported Event|LDK378 700 mg|Participants receiving 700 mg of LDK378
11046065|NCT01283516|EG008|Reported Event|LDK378 750 mg|Participants receiving 750 mg of LDK378.
11046066|NCT01283516|EG009|Reported Event|All Participants|All participants enrolled in the study
11046067|NCT01283542|BG000|Baseline|Pasireotide LAR|All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
11046068|NCT01283542|FG000|Participant Flow|Pasireotide LAR|All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
11046069|NCT01283542|OG000|Outcome|Pasireotide LAR|All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
11046070|NCT01283542|OG000|Outcome|Baseline|Baseline of Main Phase
11046071|NCT01283542|OG001|Outcome|Week 4|Week 4 of Main Phase
11046072|NCT01283542|OG002|Outcome|Week 12|Week 12 of Main Phase
11046073|NCT01283542|OG003|Outcome|Week 24|Week 24 of Main Phase
11046074|NCT01283542|OG004|Outcome|Week 48|Week 48 of Extension Phase
11046075|NCT01283542|OG005|Outcome|Week 72|Week 72 of Extension Phase
11046076|NCT01283542|OG006|Outcome|Week 96|Week 96 of Extension Phase
11046077|NCT01283542|OG001|Outcome|Week 24|Week 24 of Main Phase
11046078|NCT01283542|OG002|Outcome|Week 48|Week 48 of Extension Phase
11046079|NCT01283542|OG003|Outcome|Week 96|Week 96 of Extension Phase
11046080|NCT01283542|OG001|Outcome|Week 12|Week 12 of Main Phase
11046081|NCT01283542|OG002|Outcome|Week 24|Week 24 of Main Phase
11046082|NCT01283542|OG003|Outcome|Week 48|Week 48 of Extension Phase
11046083|NCT01283542|OG004|Outcome|Week 72|Week 72 of Extension Phase
11046084|NCT01283542|OG005|Outcome|Week 96|Week 96 of Extension Phase
11046085|NCT01283542|OG000|Outcome|Week 12|Week 12 of Main Phase
11046086|NCT01283542|OG003|Outcome|Week 72|Week 72 of Extension Phase
11046087|NCT01283542|OG004|Outcome|Week 96|Week 96 of Extension Phase
11046088|NCT01283542|EG000|Reported Event|Pasireotide LAR|All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
11046089|NCT01283555|BG000|Baseline|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
11046090|NCT01283555|FG000|Participant Flow|User-Filled Applicator First, Then Prefilled|User-filled paper applicator (filled using a tube of Tenofovir 1% gel)used twice daily in first intervention period and prefilled applicator used twice daily in second intervention period (after washout period)
11046091|NCT01283555|FG001|Participant Flow|Prefilled Applicator First, Then User-filled|Plastic applicator (prefilled with Tenofovir 1% gel) used twice daily in first intervention period and user-filled applicator used twice daily in second intervention period (after washout period)
11046092|NCT01283555|OG000|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
11046093|NCT01283555|OG001|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
11046094|NCT01283555|OG002|Outcome|Same|no preference between user-filled or prefilled applicator
11046095|NCT01283555|OG000|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
11046096|NCT01283555|OG000|Outcome|Baseline Colposcopic Findings|Number of colposcopic findings identified during baseline colposcopies for both study arms. Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
11046097|NCT01283555|OG001|Outcome|Colposcopic Findings After 7 Days of Product Use|Number of colposcopic findings identified during colposcopy after one week of twice daily product use (data from both study arms are combined). Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
11046098|NCT01283555|EG000|Reported Event|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
11046099|NCT01283555|EG001|Reported Event|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
11046100|NCT01283581|BG000|Baseline|Delafloxacin IV (Intravenous)|Delafloxacin 300 mg, BID (twice a day)
11046101|NCT01283581|BG001|Baseline|Linezolid|Linezolid 600 mg, BID
11046102|NCT01283581|BG002|Baseline|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
11046103|NCT01283581|BG003|Baseline|Total|Total of all reporting groups
11046104|NCT01283581|FG000|Participant Flow|Delafloxacin IV (Intravenous)|Delafloxacin 300 mg, BID (twice a day)
11046105|NCT01283581|FG001|Participant Flow|Linezolid IV|Linezolid 600 mg, BID
11046106|NCT01283581|FG002|Participant Flow|Vancomycin IV|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
11046107|NCT01283581|OG000|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
11046108|NCT01283581|OG001|Outcome|Linezolid|Linezolid 600 mg, BID
11046109|NCT01283581|OG002|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
11046110|NCT01283581|OG000|Outcome|Delafloxacin|"300 mg IV every 12 hours for 5-14 days~Delafloxacin: 300mg IV every 12 hours for 5-14 days"
11046111|NCT01283581|OG001|Outcome|Vancomycin|"15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas~Vancomycin: 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days"
11046112|NCT01283581|OG002|Outcome|Linezolid|"600 mg IV every 12 hours for 5-14 days~Linezolid: 600mg IV every 12 hours for 5-14 days"
11046113|NCT01283581|EG000|Reported Event|Delafloxacin IV|Delafloxacin 300 mg, BID
11046114|NCT01283581|EG001|Reported Event|Linezolid|Linezolid 600 mg, BID
11046115|NCT01283581|EG002|Reported Event|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
11046116|NCT01283971|BG000|Baseline|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
11046117|NCT01283971|BG001|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
11046118|NCT01283971|BG002|Baseline|Total|Total of all reporting groups
11046119|NCT01283971|FG000|Participant Flow|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
11046120|NCT01283971|FG001|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
11046121|NCT01283971|OG000|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
11046122|NCT01283971|OG001|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
11046123|NCT01283971|EG000|Reported Event|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
11046124|NCT01283971|EG001|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
11046125|NCT01284062|BG000|Baseline|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046126|NCT01284062|BG001|Baseline|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046127|NCT01284062|BG002|Baseline|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046128|NCT01284062|BG003|Baseline|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046129|NCT01284062|BG004|Baseline|Total|Total of all reporting groups
11046130|NCT01284062|FG000|Participant Flow|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046131|NCT01284062|FG001|Participant Flow|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046132|NCT01284062|FG002|Participant Flow|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046133|NCT01284062|FG003|Participant Flow|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046134|NCT01284062|OG000|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046135|NCT01284062|OG001|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046136|NCT01284062|OG002|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046137|NCT01284062|OG003|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046138|NCT01284062|OG000|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046139|NCT01284062|OG001|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046140|NCT01284062|OG002|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046141|NCT01284062|EG000|Reported Event|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046142|NCT01284062|EG001|Reported Event|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046143|NCT01284062|EG002|Reported Event|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046144|NCT01284062|EG003|Reported Event|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
11046145|NCT01284114|BG000|Baseline|Aliskiren|
11046146|NCT01284114|FG000|Participant Flow|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
11046147|NCT01284114|OG000|Outcome|Aliskiren|
11046148|NCT01284114|OG000|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
11046149|NCT01284114|EG000|Reported Event|Aliskiren|
11046150|NCT01284127|BG000|Baseline|Deferiprone|All patients must have MRI evidence of superficial siderosis and be treated with deferiprone according to standard of care guidelines.
11046151|NCT01284127|FG000|Participant Flow|Deferiprone|All patients must have MRI evidence of superficial siderosis and be treated with deferiprone according to standard of care guidelines.
11046152|NCT01284127|OG000|Outcome|Deferiprone|All patients must have MRI evidence of superficial siderosis and be treated with deferiprone according to standard of care guidelines.
11046153|NCT01284127|EG000|Reported Event|Deferiprone|All patients must have MRI evidence of superficial siderosis and be treated with deferiprone according to standard of care guidelines.
11046154|NCT01284140|BG000|Baseline|Sleep Promotion Protocol|"Behavioral: sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention will attempt to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. Supplemental bright lights and eyeshades and noise cancelling headphones may also be employed."
11046155|NCT01284140|BG001|Baseline|Usual Care|"Behavioral: usual care.~Usual care: Usual care."
11046156|NCT01284140|BG002|Baseline|Total|Total of all reporting groups
11046157|NCT01284140|FG000|Participant Flow|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
11046158|NCT01284140|FG001|Participant Flow|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
11046159|NCT01284140|OG000|Outcome|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
11046160|NCT01284140|OG001|Outcome|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
11046161|NCT01284140|EG000|Reported Event|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
11046162|NCT01284140|EG001|Reported Event|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
11046163|NCT01284244|BG000|Baseline|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
11046164|NCT01284244|BG001|Baseline|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
11046165|NCT01284244|BG002|Baseline|Total|Total of all reporting groups
11046166|NCT01284244|FG000|Participant Flow|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
11046167|NCT01284244|FG001|Participant Flow|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
11046168|NCT01284244|OG000|Outcome|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
11046169|NCT01284244|OG001|Outcome|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
11046170|NCT01284244|EG000|Reported Event|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
11046171|NCT01284244|EG001|Reported Event|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
11046172|NCT01284296|BG000|Baseline|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
11046173|NCT01284296|FG000|Participant Flow|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
11046174|NCT01284296|OG000|Outcome|Digital Block (All Perfusion Indices 0.29-8.3)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
11046175|NCT01284296|OG001|Outcome|Digital Block (Perfusion Indices >2.0)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss. This is a subgroup of differences with the perfusion index >2.0
11046176|NCT01284296|EG000|Reported Event|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
11046177|NCT01284335|BG000|Baseline|Arm A Tasisulam + Gemcitabine Dose Escalation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046178|NCT01284335|BG001|Baseline|Arm A Tasisulam + Gemcitabine Dose Confirmation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046179|NCT01284335|BG002|Baseline|Arm B* Tasisulam + Docetaxel Dose Escalation|Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
11046180|NCT01284335|BG003|Baseline|Arm B1 Tasisulam + Docetaxel Dose Escalation|"Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam Day 4 of a 28 day cycle. Participant's may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11226359|NCT02374164|FG002|Participant Flow|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
11226360|NCT02374164|OG000|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
11046181|NCT01284335|BG004|Baseline|Arm B2 Tasisulam + Docetaxel Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046182|NCT01284335|BG005|Baseline|Arm B2 Tasisulam + Docetaxel Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046183|NCT01284335|BG006|Baseline|Arm C Tasisulam + Temozolomide Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met"
11046184|NCT01284335|BG007|Baseline|Arm C Tasisulam + Temozolomide Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046185|NCT01284335|BG008|Baseline|Arm D* Tasisulam + Cisplatin Dose Escalation|Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
11046186|NCT01284335|BG009|Baseline|Arm D Tasisulam + Cisplatin Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046187|NCT01284335|BG010|Baseline|Arm D Tasisulam + Cisplatin Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046188|NCT01284335|BG011|Baseline|Arm E Tasisulam + Erlotinib Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046189|NCT01284335|BG012|Baseline|Arm E Tasisulam + Erlotinib Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046190|NCT01284335|BG013|Baseline|Total|Total of all reporting groups
11046191|NCT01284335|FG000|Participant Flow|Arm A Tasisulam + Gemcitabine Dose Escalation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046192|NCT01284335|FG001|Participant Flow|Arm A Tasisulam + Gemcitabine Dose Confirmation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046193|NCT01284335|FG002|Participant Flow|Arm B* Tasisulam + Docetaxel Dose Escalation|Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
11226361|NCT02374164|OG001|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
11226362|NCT02374164|OG000|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
10887330|NCT00499746|OG008|Outcome|Tramadol 400 mg|
10887331|NCT00499746|EG000|Reported Event|All Participants|
10887332|NCT00499863|BG000|Baseline|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
10887333|NCT00499863|BG001|Baseline|Placebo (PTS)|Placebo Transdermal System
11046194|NCT01284335|FG003|Participant Flow|Arm B1 Tasisulam + Docetaxel Dose Escalation|"Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046195|NCT01284335|FG004|Participant Flow|Arm B2 Tasisulam + Docetaxel Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046196|NCT01284335|FG005|Participant Flow|Arm B2 Tasisulam + Docetaxel Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046197|NCT01284335|FG006|Participant Flow|Arm C Tasisulam + Temozolomide Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met"
11046198|NCT01284335|FG007|Participant Flow|Arm C Tasisulam + Temozolomide Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046199|NCT01284335|FG008|Participant Flow|Arm D* Tasisulam + Cisplatin Dose Escalation|Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
11046200|NCT01284335|FG009|Participant Flow|Arm D Tasisulam + Cisplatin Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046201|NCT01284335|FG010|Participant Flow|Arm D Tasisulam + Cisplatin Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
10887274|NCT00499616|BG000|Baseline|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
11046202|NCT01284335|FG011|Participant Flow|Arm E Tasisulam + Erlotinib Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046203|NCT01284335|FG012|Participant Flow|Arm E Tasisulam + Erlotinib Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
10887334|NCT00499863|BG002|Baseline|Total|Total of all reporting groups
11046204|NCT01284335|OG000|Outcome|Arm A Tasisulam + Gemcitabine Dose Escalation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046205|NCT01284335|OG001|Outcome|Arm A Tasisulam + Gemcitabine Dose Confirmation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046206|NCT01284335|OG002|Outcome|Arm B* Tasisulam + Docetaxel Dose Escalation|Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
11046207|NCT01284335|OG003|Outcome|Arm B1 Tasisulam + Docetaxel Dose Escalation|"Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046208|NCT01284335|OG004|Outcome|Arm B2 Tasisulam + Docetaxel Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046209|NCT01284335|OG005|Outcome|Arm B2 Tasisulam + Docetaxel Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046210|NCT01284335|OG006|Outcome|Arm C Tasisulam + Temozolomide Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met"
11046211|NCT01284335|OG007|Outcome|Arm C Tasisulam + Temozolomide Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046212|NCT01284335|OG008|Outcome|Arm D* Tasisulam + Cisplatin Dose Escalation|Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
11046213|NCT01284335|OG009|Outcome|Arm D Tasisulam + Cisplatin Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046214|NCT01284335|OG010|Outcome|Arm D Tasisulam + Cisplatin Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
10887335|NCT00499863|FG000|Participant Flow|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
10887336|NCT00499863|FG001|Participant Flow|Placebo (PTS)|Placebo Transdermal System
11046215|NCT01284335|OG011|Outcome|Arm E Tasisulam + Erlotinib Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046216|NCT01284335|OG012|Outcome|Arm E Tasisulam + Erlotinib Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046217|NCT01284335|OG000|Outcome|Tasisulam|Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion are met.
11066702|NCT01393704|FG000|Participant Flow|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
11046218|NCT01284335|OG000|Outcome|Arm A Tasisulam + Gemcitabine Dose Confirmation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046219|NCT01284335|OG001|Outcome|Arm B* Tasisulam + Docetaxel Dose Confirmation|Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
11046220|NCT01284335|OG002|Outcome|Arm C Tasisulam + Temozolomide Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046221|NCT01284335|OG003|Outcome|Arm D Tasisulam + Cisplatin Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046222|NCT01284335|OG004|Outcome|Arm E Tasisulam + Erlotinib Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046223|NCT01284335|OG000|Outcome|Arm A Tasisulam + Gemcitabine Dose Escalation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participants height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046224|NCT01284335|OG001|Outcome|Arm A Tasisulam + Gemcitabine Dose Confirmation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participants height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046225|NCT01284335|OG002|Outcome|Arm B1 Tasisulam + Docetaxel Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046226|NCT01284335|OG003|Outcome|Arm B* Tasisulam + Docetaxel Dose Escalation|Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
11046227|NCT01284335|OG007|Outcome|Arm C Tasisulam + Temozolomide Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met"
11046228|NCT01284335|OG000|Outcome|Tasisulam|Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters
11046229|NCT01284335|EG000|Reported Event|Arm A Tasisulam + Gemcitabine Dose Escalation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11226363|NCT02374164|EG000|Reported Event|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
11226364|NCT02374164|EG001|Reported Event|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
11226365|NCT02374164|EG002|Reported Event|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
11226366|NCT02374255|BG000|Baseline|Patients - GoC Intervention|"Patients given OncoTalk GoC intervention~GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction."
11226367|NCT02374255|BG001|Baseline|Patients - Usual Care|Prospective control group where no intervention was given.
11046230|NCT01284335|EG001|Reported Event|Arm A Tasisulam + Gemcitabine Dose Confirmation|"Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046231|NCT01284335|EG002|Reported Event|Arm B* Tasisulam + Docetaxel Dose Escalation|Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
11046232|NCT01284335|EG003|Reported Event|Arm B1 Tasisulam + Docetaxel Dose Escalation|"Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.~Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met."
11046233|NCT01284335|EG004|Reported Event|Arm B2 Tasisulam + Docetaxel Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046234|NCT01284335|EG005|Reported Event|Arm B2 Tasisulam + Docetaxel Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046235|NCT01284335|EG006|Reported Event|Arm C Tasisulam + Temozolomide Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met"
11046236|NCT01284335|EG007|Reported Event|Arm C Tasisulam + Temozolomide Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046237|NCT01284335|EG008|Reported Event|Arm D* Tasisulam + Cisplatin Dose Escalation|Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
11046238|NCT01284335|EG009|Reported Event|Arm D Tasisulam+ Cisplatin Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046239|NCT01284335|EG010|Reported Event|Arm D Tasisulam+ Cisplatin Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046240|NCT01284335|EG011|Reported Event|Arm E Tasisulam + Erlotinib Dose Escalation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046241|NCT01284335|EG012|Reported Event|Arm E Tasisulam + Erlotinib Dose Confirmation|"Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.~Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met."
11046242|NCT01284361|BG000|Baseline|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
11046243|NCT01284361|FG000|Participant Flow|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
11046244|NCT01284361|OG000|Outcome|Control and Test Crossover|Control and test intermittent urinary catheters : randomized cross-over
11046245|NCT01284361|OG000|Outcome|Control 40 cm Catheter|Commercial gel lubricated 40 cm catheter
11046246|NCT01284361|OG001|Outcome|Test 30 cm Catheter|Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter
11046247|NCT01284361|EG000|Reported Event|Control 40 cm Catheter|Commercial 40 cm gel lubricated catheter
11226368|NCT02374255|BG002|Baseline|Oncologists - GoC Intervention|Oncologists trained using OncoTalk to have Goals of Care discussions.
11046248|NCT01284361|EG001|Reported Event|Test 30 cm Catheter|Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter
11046249|NCT01284426|BG000|Baseline|Chronic Urticaria|Chronic urticaria, Natural history
11226369|NCT02374255|BG003|Baseline|Oncologists - Usual Care|Oncologists not trained using OncoTalk to have Goals of Care discussions.
11226370|NCT02374255|BG004|Baseline|Total|Total of all reporting groups
11226371|NCT02374255|FG000|Participant Flow|Patients - GoC Intervention|"Patients given OncoTalk GoC intervention~GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction."
11226372|NCT02374255|FG001|Participant Flow|Patients - Usual Care|Prospective control group where no intervention was given.
11226373|NCT02374255|FG002|Participant Flow|Oncologists - GoC Intervention|Oncologists trained using OncoTalk to have Goals of Care discussions.
11226374|NCT02374255|FG003|Participant Flow|Oncologists - Usual Care|Oncologists not trained using OncoTalk to have Goals of Care discussions.
11226375|NCT02374255|OG000|Outcome|Patients - GoC Intervention|"Patients given OncoTalk GoC intervention~GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction."
11046250|NCT01284426|FG000|Participant Flow|Chronic Urticaria|Chronic urticaria, Natural history
11046251|NCT01284426|OG000|Outcome|Chronic Urticaria|Chronic urticaria, Natural history
11046252|NCT01284426|EG000|Reported Event|Chronic Urticaria|Chronic urticaria, Natural history
11226376|NCT02374255|OG001|Outcome|Patients - Usual Care|Prospective control group where no intervention was given.
11226377|NCT02374255|OG002|Outcome|Oncologist - GoC Intervention|Oncologists trained using OncoTalk to have Goals of Care discussions.
11226378|NCT02374255|OG003|Outcome|Oncologists - Usual Care|Oncologists not trained using OncoTalk to have Goals of Care discussions.
11226379|NCT02374255|OG000|Outcome|Patients - GoC Intervention|"Patients given OncoTalk GoC intervention.~GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction."
11226380|NCT02374255|OG002|Outcome|Oncologists - GoC Intervention|Oncologists trained using OncoTalk to have Goals of Care discussions.
11226381|NCT02374255|OG000|Outcome|Oncologists - GoC Intervention|"Oncologists trained using OncoTalk to have Goals of Care discussions.~GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction."
11226382|NCT02374255|OG001|Outcome|Oncologists - Usual Care|Oncologists not trained using OncoTalk to have Goals of Care discussions.
11226383|NCT02374255|OG002|Outcome|Patients - GoC Intervention|"Patients given OncoTalk GoC intervention.~GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction."
11226384|NCT02374255|OG003|Outcome|Patients - Usual Care|Prospective control group where no intervention was given.
11226385|NCT02374255|EG000|Reported Event|Patients - GoC Intervention|"Patients given OncoTalk GoC intervention~GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction."
11046253|NCT01284517|BG000|Baseline|Lurasidone 20-120 mg Flexible Dose+Li/VPA|
11046254|NCT01284517|BG001|Baseline|Placebo + Li/VPA|
11046255|NCT01284517|BG002|Baseline|Total|Total of all reporting groups
11046256|NCT01284517|FG000|Participant Flow|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
11046257|NCT01284517|FG001|Participant Flow|Placebo + Li/VPA|Placebo + Lithium/divalproex
11046258|NCT01284517|OG000|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
11046259|NCT01284517|OG001|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
11226386|NCT02374255|EG001|Reported Event|Patients - Usual Care|Prospective control group where no intervention was given.
11226387|NCT02374255|EG002|Reported Event|Oncologists - GoC Intervention|Oncologists trained using OncoTalk to have Goals of Care discussions.
11226388|NCT02374255|EG003|Reported Event|Oncologists - Usual Care|Oncologists not trained using OncoTalk to have Goals of Care discussions.
11226389|NCT02374307|BG000|Baseline|Intervention|Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
11226390|NCT02374307|BG001|Baseline|Control|Activities as usual.
11226391|NCT02374307|BG002|Baseline|Total|Total of all reporting groups
11226392|NCT02374307|FG000|Participant Flow|Intervention|Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
11226393|NCT02374307|FG001|Participant Flow|Control|Activities as usual.
11226394|NCT02374307|OG000|Outcome|Intervention|Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
11226395|NCT02374307|OG001|Outcome|Control|Activities as usual.
11226396|NCT02374307|EG000|Reported Event|Intervention|Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
11226397|NCT02374307|EG001|Reported Event|Control|Activities as usual.
11226398|NCT02374346|BG000|Baseline|Elective Surgery Patients|All adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ear-nose-throat (ENT) and vascular procedures.
11226399|NCT02374346|FG000|Participant Flow|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
11226400|NCT02374346|OG000|Outcome|Elective Surgery Patients (Total Sample)|postoperative headache in elective surgery patients
11226401|NCT02374346|OG000|Outcome|Postoperative Headache in the Total Sample|Factors for developing postoperative headache in the total number of participants
11226402|NCT02374346|OG001|Outcome|Postoperative Headache Patients Without Headache History|Factors for developing postoperative headache in patients without previous history of headache.
11046260|NCT01284517|EG000|Reported Event|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
11046261|NCT01284517|EG001|Reported Event|Placebo + Li/VPA|Placebo (PO)+ Lithium/divalproex
11046262|NCT01284621|BG000|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were~Empagliflozin alone~Ramipril~Empagliflozin plus Ramipril~Each treatment period was 8 days, with drug administration on days 1 to 5, and they were separated by a washout period of at least 7 days between drug administrations of 2 subsequent treatments."
11046263|NCT01284621|FG000|Participant Flow|Empa Alone / Empa + Ramipril / Ramipril Alone|"Patients were administered three treatments in the following order:~Empagliflozin alone~Empagliflozin plus Ramipril~Ramipril"
11046264|NCT01284621|FG001|Participant Flow|Empa Alone / Ramipril Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:~Empagliflozin alone~Ramipril~Empagliflozin plus Ramipril"
11046265|NCT01284621|FG002|Participant Flow|Ramipril Alone / Empa Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:~Ramipril~Empagliflozin alone~Empagliflozin plus Ramipril"
11046266|NCT01284621|FG003|Participant Flow|Ramipril Alone / Empa + Ramipril / Empa Alone|"Patients were administered three treatments in the following order:~Ramipril~Empagliflozin plus Ramipril~Empagliflozin alone"
11046267|NCT01284621|FG004|Participant Flow|Empa + Ramipril / Empa Alone / Ramipril Alone|"Patients were administered three treatments in the following order:~Empagliflozin plus Ramipril~Empagliflozin alone~Ramipril"
11046268|NCT01284621|FG005|Participant Flow|Empa + Ramipril / Ramipril Alone / Empa Alone|"Patients were administered three treatments in the following order:~Empagliflozin plus Ramipril~Ramipril~Empagliflozin alone"
11046269|NCT01284621|OG000|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
11046270|NCT01284621|OG001|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
10887337|NCT00499863|OG000|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
10887338|NCT00499863|OG001|Outcome|Placebo (PTS)|Placebo Transdermal System
11046271|NCT01284621|OG000|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
11046272|NCT01284621|OG001|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
11046273|NCT01284621|OG002|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
11046274|NCT01284621|EG000|Reported Event|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
11046275|NCT01284621|EG001|Reported Event|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
11046276|NCT01284621|EG002|Reported Event|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
11046277|NCT01284634|BG000|Baseline|GWP42003 200 mg/Day Dose|Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046278|NCT01284634|BG001|Baseline|GWP42003 400 mg/Day Dose|Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046279|NCT01284634|BG002|Baseline|GWP42003 800 mg/Day Dose|Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046280|NCT01284634|BG003|Baseline|Placebo|Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046281|NCT01284634|BG004|Baseline|Total|Total of all reporting groups
11046282|NCT01284634|FG000|Participant Flow|GWP42003 200 Milligram (mg)/Day Dose|Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046283|NCT01284634|FG001|Participant Flow|GWP42003 400 mg/Day Dose|Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046284|NCT01284634|FG002|Participant Flow|GWP42003 800 mg/Day Dose|Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046285|NCT01284634|FG003|Participant Flow|Placebo|Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046286|NCT01284634|OG000|Outcome|GWP42003 200 mg/Day Dose|Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046287|NCT01284634|OG001|Outcome|GWP42003 400 mg/Day Dose|Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046288|NCT01284634|OG002|Outcome|GWP42003 800 mg/Day Dose|Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046289|NCT01284634|OG003|Outcome|Placebo|Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046290|NCT01284634|EG000|Reported Event|GWP42003 200 mg/Day Dose|Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046291|NCT01284634|EG001|Reported Event|GWP42003 400 mg/Day Dose|Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046292|NCT01284634|EG002|Reported Event|800 mg GWP42003|Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046293|NCT01284634|EG003|Reported Event|Placebo|Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
11046294|NCT01284959|BG000|Baseline|Risperidone|Drug: risperidone Groups: risperidone
11046295|NCT01284959|BG001|Baseline|Placebo|drug: lactose group: placebo
11046296|NCT01284959|BG002|Baseline|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
11046297|NCT01284959|BG003|Baseline|Total|Total of all reporting groups
11046298|NCT01284959|FG000|Participant Flow|Risperidone|Drug: risperidone Groups: risperidone
11226403|NCT02374346|EG000|Reported Event|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
10887339|NCT00499863|EG000|Reported Event|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
10887340|NCT00499863|EG001|Reported Event|Placebo (PTS)|Placebo Transdermal System
11046299|NCT01284959|FG001|Participant Flow|Placebo|drug: lactose group: placebo
11046300|NCT01284959|FG002|Participant Flow|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
11046301|NCT01284959|OG000|Outcome|Risperidone|Drug: risperidone Groups: risperidone
11046302|NCT01284959|OG001|Outcome|Placebo|drug: lactose group: placebo
11046303|NCT01284959|OG002|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
11046304|NCT01284959|EG000|Reported Event|Risperidone|Drug: risperidone Groups: risperidone
11046305|NCT01284959|EG001|Reported Event|Placebo|drug: lactose group: placebo
11046306|NCT01284959|EG002|Reported Event|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
11046307|NCT01285024|BG000|Baseline|Control|No Vitagel used during total hip arthroplasty
11046308|NCT01285024|BG001|Baseline|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
11046309|NCT01285024|BG002|Baseline|Total|Total of all reporting groups
11046310|NCT01285024|FG000|Participant Flow|Control|No Vitagel used during total hip arthroplasty
11046311|NCT01285024|FG001|Participant Flow|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
11046312|NCT01285024|OG000|Outcome|Control|No Vitagel used during total hip arthroplasty
11046313|NCT01285024|OG001|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
11046314|NCT01285024|EG000|Reported Event|Control|No Vitagel used during total hip arthroplasty
11046315|NCT01285024|EG001|Reported Event|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
11046316|NCT01285050|BG000|Baseline|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
11046317|NCT01285050|FG000|Participant Flow|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
11046318|NCT01285050|OG000|Outcome|Pre ART HCV RNA Decline|"HCV viral load determined by RT-PCR and reported as log IU/ml before giving antiretroviral therapy (ART)~Interferon alfa-2b was administered once as part of a pharmacokinetic study before and after ART.~ART included:~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
11046319|NCT01285050|OG001|Outcome|Post ART HCV Decline|HCV RNA determined by RT-PCR and expressed as log IU/ml after ART
11046320|NCT01285050|EG000|Reported Event|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
11046321|NCT01285076|BG000|Baseline|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
11046322|NCT01285076|FG000|Participant Flow|All Enrolled Participants|Adults with Type 2 diabetes mellitus (DM) ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
11046323|NCT01285076|OG000|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
11046324|NCT01285076|EG000|Reported Event|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
11046325|NCT01285310|BG000|Baseline|Placebo|Placebo: Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders were transitioned early to 20 mg Apremilast BID at Week 16.
11046326|NCT01285310|BG001|Baseline|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
11046327|NCT01285310|BG002|Baseline|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
11046328|NCT01285310|BG003|Baseline|Total|Total of all reporting groups
11046329|NCT01285310|FG000|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg Apremilast twice daily (early escape), and were designated as Placebo/Apremilast 20mg EE.
11046330|NCT01285310|FG001|Participant Flow|Apremilast 20 mg|"Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.~At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
11046331|NCT01285310|FG002|Participant Flow|Apremilast 30 mg|"Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.~At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
11046332|NCT01285310|FG003|Participant Flow|Placebo/Apremilast 20mg EE|"Participants initially randomized to receive placebo twice daily and were transitioned due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to week 24.~At week 24, participants were continued on Apremilast 20 mg BID for up to Week 52.~At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
11046333|NCT01285310|FG004|Participant Flow|Placebo / Apremilast 20 mg XO|"Participants initially randomized to receive placebo twice daily who were transitioned at Week 24 (XO) to receive 20 mg apremilast for up to Week 52.~At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
11046334|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
11046335|NCT01285310|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
11046336|NCT01285310|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
11046337|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
11046338|NCT01285310|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
11046339|NCT01285310|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
11046340|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE
11046341|NCT01285310|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
11046342|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily
11046343|NCT01285310|OG001|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
11046344|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape).
11046345|NCT01285310|OG001|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily
11046346|NCT01285310|OG002|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily
11046347|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE ..
11046348|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE .
11046349|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape)and were designated as Placebo/Apremilast 20mg EE.
11046350|NCT01285310|OG002|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily.
11046351|NCT01285310|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
10887275|NCT00499616|BG001|Baseline|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11046352|NCT01285310|OG000|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
11046353|NCT01285310|OG001|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
11046354|NCT01285310|OG002|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
11046355|NCT01285310|OG003|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
11046356|NCT01285310|OG001|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned transitioned to receive 20 mg apremilast twice daily.
11046357|NCT01285310|OG000|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
11046358|NCT01285310|OG001|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
11046359|NCT01285310|OG001|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily
11046360|NCT01285310|OG001|Outcome|Placebo/Apremilast 20 mg XO|.Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
11046361|NCT01285310|OG000|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
11046362|NCT01285310|OG001|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
11046363|NCT01285310|OG000|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
11046364|NCT01285310|OG001|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
11046365|NCT01285310|EG000|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
11046366|NCT01285310|EG001|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
11046367|NCT01285310|EG002|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
11046368|NCT01285310|EG003|Reported Event|Study Termination: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
11046369|NCT01285310|EG004|Reported Event|Study Termination: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
11046370|NCT01285323|BG000|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046371|NCT01285323|BG001|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046372|NCT01285323|BG002|Baseline|Total|Total of all reporting groups
11046373|NCT01285323|FG000|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046374|NCT01285323|FG001|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046375|NCT01285323|OG000|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046376|NCT01285323|OG001|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046377|NCT01285323|EG000|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046378|NCT01285323|EG001|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11066703|NCT01393704|FG001|Participant Flow|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
11066704|NCT01393704|OG000|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
11066705|NCT01393704|OG001|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
11066706|NCT01393704|EG000|Reported Event|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
11046379|NCT01285349|BG000|Baseline|Couple Wellness Promotion|"7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.~Couple Wellness Promotion :"
11046380|NCT01285349|BG001|Baseline|Couple-based HIV Prevention|"7-session couple-based HIV/STI risk reduction intervention (CSTI)~Couple HIV/STI prevention intervention :~Couple-based HIV prevention :"
11046381|NCT01285349|BG002|Baseline|Individual HIV/STI Prevention|"7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.~Individual HIV/STI prevention :"
11046382|NCT01285349|BG003|Baseline|Total|Total of all reporting groups
11046383|NCT01285349|FG000|Participant Flow|Couple Wellness Promotion|"7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.~Couple Wellness Promotion :"
11046384|NCT01285349|FG001|Participant Flow|Couple-based HIV Prevention|"7-session couple-based HIV/STI risk reduction intervention (CSTI)~Couple HIV/STI prevention intervention :~Couple-based HIV prevention :"
11046385|NCT01285349|FG002|Participant Flow|Individual HIV/STI Prevention|"7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.~Individual HIV/STI prevention :"
11046386|NCT01285349|OG000|Outcome|Couple-Based Wellness Promotion|"7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.~Couple Wellness Promotion :"
11046387|NCT01285349|OG001|Outcome|Couple-based HIV Prevention|"7-session couple-based HIV/STI risk reduction intervention (CSTI)~Couple HIV/STI prevention intervention :~Couple-based HIV prevention :"
11046388|NCT01285349|OG002|Outcome|Individual HIV/STI Prevention|"7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.~Individual HIV/STI prevention :"
11046389|NCT01285349|OG000|Outcome|Couple Wellness Promotion|"7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.~Couple Wellness Promotion :"
11046390|NCT01285349|EG000|Reported Event|Couple Wellness Promotion|"7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.~Couple Wellness Promotion :"
11046391|NCT01285349|EG001|Reported Event|Couple-based HIV Prevention|"7-session couple-based HIV/STI risk reduction intervention (CSTI)~Couple HIV/STI prevention intervention :~Couple-based HIV prevention :"
11046392|NCT01285349|EG002|Reported Event|Individual HIV/STI Prevention|"7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.~Individual HIV/STI prevention :"
11046393|NCT01285401|BG000|Baseline|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
11046394|NCT01285401|BG001|Baseline|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
11046395|NCT01285401|BG002|Baseline|Total|Total of all reporting groups
11046396|NCT01285401|FG000|Participant Flow|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25-hydroxyvitamin D [25(OH)D3] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) [167 microgram per day (mcg/d)] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).
11046397|NCT01285401|FG001|Participant Flow|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
11046398|NCT01285401|OG000|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
11046399|NCT01285401|OG001|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
11046400|NCT01285401|EG000|Reported Event|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
11046401|NCT01285401|EG001|Reported Event|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
11046402|NCT01285427|BG000|Baseline|DNA Loci (SeCore vs. SSP UniTray Platforms)|
11046403|NCT01285427|FG000|Participant Flow|DNA Loci (SeCore vs. SSP UniTray Platforms)|
11046404|NCT01285427|OG000|Outcome|Concordance|All SeCore Kits
11046405|NCT01285427|OG000|Outcome|Concordance|SeCore kit, A Locus
11046406|NCT01285427|OG000|Outcome|SeCore® Kit, B Locus (Single Amp)|SeCore® Kit, B Locus (Single Amp)
11046407|NCT01285427|OG000|Outcome|SeCore® Kit, C Locus|SeCore® Kit, C Locus
11046408|NCT01285427|OG000|Outcome|SeCore® DPB1 Locus Kit|SeCore® DPB1 Locus Kit
11046409|NCT01285427|OG000|Outcome|SeCore® Kit, DQB1 Locus|SeCore® Kit, DQB1 Locus
11046410|NCT01285427|OG000|Outcome|SeCore® Kit, DRB1 Locus|SeCore® Kit, DRB1 Locus
11046411|NCT01285427|OG000|Outcome|SeCore® Kit, DR Group Kit (DRB1 Locus)|SeCore® Kit, DR Group Kit (DRB1 Locus),
11046412|NCT01285427|OG000|Outcome|SeCore® Kit, DR Group Kit (DRB345 Loci)|SeCore® Kit, DR Group Kit (DRB345 Loci),
11046413|NCT01285427|EG000|Reported Event|Concordance|All SeCore Kits
11046414|NCT01285492|BG000|Baseline|QVA149|QVA149 110/50 μg once a day (o.d)
11046415|NCT01285492|BG001|Baseline|Tiotropium|tiotropium 18 μg o.d.
11046416|NCT01285492|BG002|Baseline|Total|Total of all reporting groups
11046417|NCT01285492|FG000|Participant Flow|QVA149|QVA149 110/50 μg o.d. (once a day)
11046418|NCT01285492|FG001|Participant Flow|Tiotropium|tiotropium 18 μg o.d.
11046419|NCT01285492|OG000|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
11046420|NCT01285492|OG001|Outcome|Tiotropium|tiotropium 18 μg o.d.
11046421|NCT01285492|EG000|Reported Event|QVA149|QVA149 110/50 μg once a day (o.d)
11226404|NCT02374398|BG000|Baseline|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
11226405|NCT02374398|BG001|Baseline|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts~Aquamantys System: see arm/group descriptions"
11226406|NCT02374398|BG002|Baseline|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
11226407|NCT02374398|BG003|Baseline|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
11226408|NCT02374398|BG004|Baseline|Total|Total of all reporting groups
11226409|NCT02374398|FG000|Participant Flow|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
11226410|NCT02374398|FG001|Participant Flow|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts~Aquamantys System: see arm/group descriptions"
11226411|NCT02374398|FG002|Participant Flow|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
11046422|NCT01285492|EG001|Reported Event|Tiotropium|tiotropium 18 μg o.d.
11226412|NCT02374398|FG003|Participant Flow|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
11226413|NCT02374398|OG000|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
11226414|NCT02374398|OG001|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts~Aquamantys System: see arm/group descriptions"
11226415|NCT02374398|OG002|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
11226416|NCT02374398|OG003|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
11226417|NCT02374398|OG003|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control: Standard Electro-cautery and Saline"
11226418|NCT02374398|EG000|Reported Event|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
11226419|NCT02374398|EG001|Reported Event|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts~Aquamantys System: see arm/group descriptions"
11226420|NCT02374398|EG002|Reported Event|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
10887341|NCT00499889|BG000|Baseline|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
11046423|NCT01285518|BG000|Baseline|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
11046424|NCT01285518|BG001|Baseline|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
11046425|NCT01285518|BG002|Baseline|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
11046426|NCT01285518|BG003|Baseline|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
11046427|NCT01285518|BG004|Baseline|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
11046428|NCT01285518|BG005|Baseline|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
11046429|NCT01285518|BG006|Baseline|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
11046430|NCT01285518|BG007|Baseline|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
11046431|NCT01285518|BG008|Baseline|Total|Total of all reporting groups
11046432|NCT01285518|FG000|Participant Flow|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
11046433|NCT01285518|FG001|Participant Flow|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
11046434|NCT01285518|FG002|Participant Flow|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
11046435|NCT01285518|FG003|Participant Flow|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
11046436|NCT01285518|FG004|Participant Flow|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
11046437|NCT01285518|FG005|Participant Flow|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
11046438|NCT01285518|FG006|Participant Flow|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
11046439|NCT01285518|FG007|Participant Flow|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
11046440|NCT01285518|OG000|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
11046441|NCT01285518|OG001|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
10848959|NCT00293033|FG000|Participant Flow|Onsolis|Subjects were administered BEMA™ Fentanyl at escalating doses (200, 400, 600, 800, and 1200 μg) in Titration period. During the double-blind period, subjects were randomly assigned to a sequence of active and placebo discs. Each subject acted as his or her own control. For each subject, the sequencing of the placebo and BEMA™ Fentanyl discs was random.
11046442|NCT01285518|OG002|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
11046443|NCT01285518|OG003|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
11046444|NCT01285518|OG004|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
11046445|NCT01285518|OG005|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
11046446|NCT01285518|OG006|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
11046447|NCT01285518|OG007|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
11046448|NCT01285518|OG000|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
11046449|NCT01285518|EG000|Reported Event|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
11046450|NCT01285518|EG001|Reported Event|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
11046451|NCT01285518|EG002|Reported Event|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
11046452|NCT01285518|EG003|Reported Event|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
11046453|NCT01285518|EG004|Reported Event|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
11046454|NCT01285518|EG005|Reported Event|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
11046455|NCT01285518|EG006|Reported Event|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
11046456|NCT01285518|EG007|Reported Event|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
11046457|NCT01285609|BG000|Baseline|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046458|NCT01285609|BG001|Baseline|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046459|NCT01285609|BG002|Baseline|Total|Total of all reporting groups
10848960|NCT00293033|OG000|Outcome|Onsolis|BioErodible MucoAdhesive (BEMA) Fentanyl
10848961|NCT00293033|OG001|Outcome|Placebo|Placebo Disc
10848962|NCT00293033|OG001|Outcome|Placebo|Placebo DIsc
11226421|NCT02374398|EG003|Reported Event|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
11046460|NCT01285609|FG000|Participant Flow|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046461|NCT01285609|FG001|Participant Flow|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046462|NCT01285609|OG000|Outcome|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046463|NCT01285609|OG001|Outcome|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046464|NCT01285609|OG000|Outcome|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046465|NCT01285609|OG001|Outcome|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046466|NCT01285609|EG000|Reported Event|10 MG/KG Ipilimumab + Paclitaxel/ Carbop|Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046467|NCT01285609|EG001|Reported Event|Placebo + Paclitaxel/ Carboplatin|Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
11046468|NCT01285635|BG000|Baseline|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046469|NCT01285635|BG001|Baseline|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
11046470|NCT01285635|BG002|Baseline|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046471|NCT01285635|BG003|Baseline|Total|Total of all reporting groups
11046472|NCT01285635|FG000|Participant Flow|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11226422|NCT02374463|BG000|Baseline|MMBI|Multimodality Balance Intervention (MMBI)
10848963|NCT00293033|OG000|Outcome|Onsolis|BioErodible MucoAdhesive (BEMA) Fentanyl - Includes all subjects and all dose levels.
10848964|NCT00293033|OG001|Outcome|Placebo|Placebo Disc - Includes all subjects and all dose levels.
11046473|NCT01285635|FG001|Participant Flow|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
10849047|NCT00293397|OG000|Outcome|Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE)|"Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.~doxorubicin hydrochloride: Doxorubicin eluting beads"
11046474|NCT01285635|FG002|Participant Flow|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046475|NCT01285635|OG000|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046476|NCT01285635|OG001|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046477|NCT01285635|OG002|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046478|NCT01285635|OG000|Outcome|Docetaxel and AT-101|"Patients all receive Docetaxel 75mg/m^2 on Day 1. Patients will receive AT-101 on one of the following arms:~Arm A: Docetaxel alone for two weeks, then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.~Arm B: AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles~Arm C: AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles."
11046479|NCT01285635|OG001|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
11046480|NCT01285635|OG001|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046481|NCT01285635|EG000|Reported Event|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046482|NCT01285635|EG001|Reported Event|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046483|NCT01285635|EG002|Reported Event|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
11046484|NCT01285713|BG000|Baseline|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
11046485|NCT01285713|BG001|Baseline|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
11046486|NCT01285713|BG002|Baseline|Total|Total of all reporting groups
11046487|NCT01285713|FG000|Participant Flow|5% Dextrose (D5) in Normal Saline (NS)|10cc/kg 5% Dextrose (D5) in Normal Saline (NS) (D5NS), followed by 30cc/kg Normal Saline (NS)
11046488|NCT01285713|FG001|Participant Flow|Normal Saline (NS)|10cc/kg NS, followed by 30cc/kg NS
11046489|NCT01285713|OG000|Outcome|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
11046490|NCT01285713|OG001|Outcome|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
11046491|NCT01285713|EG000|Reported Event|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
11046492|NCT01285713|EG001|Reported Event|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
11046493|NCT01285791|BG000|Baseline|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
11046494|NCT01285791|BG001|Baseline|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
11046495|NCT01285791|BG002|Baseline|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
11046496|NCT01285791|BG003|Baseline|Total|Total of all reporting groups
11046497|NCT01285791|FG000|Participant Flow|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
11046498|NCT01285791|FG001|Participant Flow|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
11046499|NCT01285791|FG002|Participant Flow|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
11046500|NCT01285791|OG000|Outcome|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
11046501|NCT01285791|OG001|Outcome|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
11046502|NCT01285791|OG002|Outcome|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
11046503|NCT01285791|EG000|Reported Event|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
11046504|NCT01285791|EG001|Reported Event|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
11046505|NCT01285791|EG002|Reported Event|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
11046506|NCT01285843|BG000|Baseline|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
11226423|NCT02374463|BG001|Baseline|Tai Chi|Tai Chi Intervention
11226424|NCT02374463|BG002|Baseline|Total|Total of all reporting groups
11046507|NCT01285843|BG001|Baseline|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
11046508|NCT01285843|BG002|Baseline|Total|Total of all reporting groups
11046509|NCT01285843|FG000|Participant Flow|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
11046510|NCT01285843|FG001|Participant Flow|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
11046511|NCT01285843|OG000|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
11046512|NCT01285843|OG001|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
11046513|NCT01285843|EG000|Reported Event|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
11046514|NCT01285843|EG001|Reported Event|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
11046515|NCT01285908|BG000|Baseline|All Study Participants|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or Pure Autonomic Failure.
11046516|NCT01285908|FG000|Participant Flow|Baseline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees). Baseline measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
11046517|NCT01285908|FG001|Participant Flow|Saline, Then Norepinephrine|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of saline followed by IV administration of norepinephrine. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
11046518|NCT01285908|FG002|Participant Flow|Norepinephrine, Then Saline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of norepinephrine followed by IV administration of saline. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
11046519|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
11046520|NCT01285908|OG001|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
11046521|NCT01285908|OG002|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
11046522|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of diastolic blood pressure taken at varying tilt angles.
11046523|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of heart rate taken at varying tilt angles.
11046524|NCT01285908|OG001|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a saline infusion.
11046525|NCT01285908|OG002|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a norepinephrine infusion.
11046526|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac stroke volume taken at varying tilt angles.
11046527|NCT01285908|OG001|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a saline infusion.
11046528|NCT01285908|OG002|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a norepinephrine infusion.
11046529|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of average blood pressure taken at varying tilt angles.
11046530|NCT01285908|OG001|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a saline infusion.
11046531|NCT01285908|OG002|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a norepinephrine infusion.
11046532|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac output taken at varying tilt angles.
11046533|NCT01285908|OG001|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a saline infusion.
11046534|NCT01285908|OG002|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a norepinephrine infusion.
11226868|NCT02378714|FG002|Participant Flow|Standard Treatment + Active Varenicline|"Standard behavioral smoking cessation treatment plus active varenicline~Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.~Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11046535|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of total peripheral resistance taken at varying tilt angles.
11046536|NCT01285908|OG001|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a saline infusion.
11046537|NCT01285908|OG002|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a norepinephrine infusion.
11046538|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of plasma levels of norepinephrine at varying tilt angles.
11046539|NCT01285908|OG001|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a saline infusion.
11046540|NCT01285908|OG002|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a norepinephrine infusion.
11046541|NCT01285908|OG000|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of plasma levels of dihydroxyphenylglycol at varying tilt angles.
11046542|NCT01285908|OG001|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a saline infusion.
11046543|NCT01285908|OG002|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a norepinephrine infusion.
11046544|NCT01285908|EG000|Reported Event|Baseline|The participants are patients with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of BP at varying tilt angles.
11046545|NCT01285908|EG001|Reported Event|Saline, Then Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of saline, followed by IV administration of norepinephrine.
11046546|NCT01285908|EG002|Reported Event|Norepinephrine, Then Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of norepinephrine, followed by IV administration of saline.
11046547|NCT01285960|BG000|Baseline|ExAblate Treatment UF V2|"ExAblate MRgFUS Treatment~ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period."
11046548|NCT01285960|FG000|Participant Flow|ExAblate Treatment UF V2|"ExAblate MRgFUS Treatment~ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period."
11046549|NCT01285960|OG000|Outcome|ExAblate Treatment UF V2|"ExAblate MRgFUS Treatment~ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period."
11046550|NCT01285960|EG000|Reported Event|ExAblate Treatment UF V2|"ExAblate MRgFUS Treatment~ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period."
11046551|NCT01286012|BG000|Baseline|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
11046552|NCT01286012|BG001|Baseline|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
11046553|NCT01286012|BG002|Baseline|Total|Total of all reporting groups
11046554|NCT01286012|FG000|Participant Flow|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
11046555|NCT01286012|FG001|Participant Flow|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
11046556|NCT01286012|OG000|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
11046557|NCT01286012|OG001|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
11046558|NCT01286012|OG000|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
11046559|NCT01286012|EG000|Reported Event|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
11046560|NCT01286012|EG001|Reported Event|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
11046561|NCT01286077|BG000|Baseline|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
11046562|NCT01286077|BG001|Baseline|Non-treated Control|no treatment, observation only
11046563|NCT01286077|BG002|Baseline|Total|Total of all reporting groups
11046564|NCT01286077|FG000|Participant Flow|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
11046565|NCT01286077|FG001|Participant Flow|Non-treated Control|no treatment, observation only
11046566|NCT01286077|OG000|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
11046567|NCT01286077|OG001|Outcome|Non-treated Control|no treatment, observation only
11046568|NCT01286077|EG000|Reported Event|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
11046569|NCT01286077|EG001|Reported Event|Non-treated Control|no treatment, observation only
11046570|NCT01286129|BG000|Baseline|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
11046571|NCT01286129|BG001|Baseline|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
11046572|NCT01286129|BG002|Baseline|Total|Total of all reporting groups
11046573|NCT01286129|FG000|Participant Flow|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
11046574|NCT01286129|FG001|Participant Flow|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
11046575|NCT01286129|OG000|Outcome|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
11046576|NCT01286129|OG001|Outcome|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
11046577|NCT01286129|OG000|Outcome|Allergic Asthmatic|Change in nasal lavage eosinophil percentages in allergic asthmatic at baseline and at 7h post first and last challenge
11046578|NCT01286129|OG001|Outcome|Allergic Non Asthmatic|Change in nasal lavage eosinophil percentages in allergic non asthmatic at baseline and at 7h post first and last challenge
11046579|NCT01286129|EG000|Reported Event|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
11046580|NCT01286129|EG001|Reported Event|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
11046581|NCT01286168|BG000|Baseline|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
11046582|NCT01286168|FG000|Participant Flow|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
11046583|NCT01286168|OG000|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
11046584|NCT01286168|EG000|Reported Event|Antisepsis Side|"A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.~Sodium hypochlorite (Dakin's Solution): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day~Chlorhexidine gluconate disk: Apply one chlorhexidine disk to the intervention drain site(s) and change every three days~Occlusive Adhesive Dressing: A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days."
11046585|NCT01286168|EG001|Reported Event|Control Side|"Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.~Control: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care."
11046586|NCT01286259|BG000|Baseline|Intervention Arm|Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
11046587|NCT01286259|FG000|Participant Flow|Intervention Arm|Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
11046588|NCT01286259|OG000|Outcome|Intervention Arm|Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
11046589|NCT01286259|EG000|Reported Event|Intervention Arm|Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
11046590|NCT01286311|BG000|Baseline|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
11046591|NCT01286311|BG001|Baseline|Control|
11046592|NCT01286311|BG002|Baseline|Total|Total of all reporting groups
11046593|NCT01286311|FG000|Participant Flow|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
11046594|NCT01286311|FG001|Participant Flow|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores.
11046595|NCT01286311|OG000|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
11046596|NCT01286311|OG001|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
11046597|NCT01286311|EG000|Reported Event|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
11046598|NCT01286311|EG001|Reported Event|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
11046599|NCT01286324|BG000|Baseline|Placebo Tablet|Contained lactose
11046600|NCT01286324|BG001|Baseline|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
11046601|NCT01286324|BG002|Baseline|Total|Total of all reporting groups
11046602|NCT01286324|FG000|Participant Flow|Placebo Tablet|Contained lactose
11046603|NCT01286324|FG001|Participant Flow|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
11046604|NCT01286324|OG000|Outcome|Placebo Tablet|Contained lactose
11046605|NCT01286324|OG001|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
11046606|NCT01286324|EG000|Reported Event|Placebo Tablet|Contained lactose
11046607|NCT01286324|EG001|Reported Event|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
11046608|NCT01286402|BG000|Baseline|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days~- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
11046609|NCT01286402|BG001|Baseline|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
11046610|NCT01286402|BG002|Baseline|Total|Total of all reporting groups
11046611|NCT01286402|FG000|Participant Flow|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days~- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
11046612|NCT01286402|FG001|Participant Flow|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
11046613|NCT01286402|OG000|Outcome|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days~- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
11046614|NCT01286402|OG001|Outcome|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
11046615|NCT01286402|EG000|Reported Event|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days~- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
11046616|NCT01286402|EG001|Reported Event|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
11046617|NCT01286441|BG000|Baseline|Placebo|"Placebo for East Indian Sandalwood Oil ointment administered topically twice daily~Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046618|NCT01286441|BG001|Baseline|10% EISO|"East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily~10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046619|NCT01286441|BG002|Baseline|20% EISO|"East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily~20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046620|NCT01286441|BG003|Baseline|30% EISO|"East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily~30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046621|NCT01286441|BG004|Baseline|Total|Total of all reporting groups
11046622|NCT01286441|FG000|Participant Flow|Placebo|"Placebo for East Indian Sandalwood Oil ointment administered topically twice daily~Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046623|NCT01286441|FG001|Participant Flow|10% EISO|"East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily~10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046624|NCT01286441|FG002|Participant Flow|20% EISO|"East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily~20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046625|NCT01286441|FG003|Participant Flow|30% EISO|"East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily~30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046626|NCT01286441|OG000|Outcome|Placebo|"Placebo for East Indian Sandalwood Oil ointment administered topically twice daily~Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046627|NCT01286441|OG001|Outcome|10% EISO|"East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily~10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046628|NCT01286441|OG002|Outcome|20% EISO|"East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily~20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
10887276|NCT00499616|BG002|Baseline|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S disease who achieve a very good PR (VGPR) to chemo (with the exception of resolution of skin or liver metastases in stage 4S patients) proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11046629|NCT01286441|OG003|Outcome|30% EISO|"East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily~30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046630|NCT01286441|EG000|Reported Event|Placebo|"Placebo for East Indian Sandalwood Oil ointment administered topically twice daily~Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046631|NCT01286441|EG001|Reported Event|10% EISO|"East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily~10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11066707|NCT01393704|EG001|Reported Event|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
11066708|NCT01393717|BG000|Baseline|All Study Participants|Patients receive salvage brentuximab vedotin IV.
11046632|NCT01286441|EG002|Reported Event|20% EISO|"East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily~20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046633|NCT01286441|EG003|Reported Event|30% EISO|"East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily~30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks."
11046634|NCT01286454|BG000|Baseline|Entire Study Population|Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.
11046635|NCT01286454|FG000|Participant Flow|Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER|Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046636|NCT01286454|FG001|Participant Flow|Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046637|NCT01286454|FG002|Participant Flow|Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046638|NCT01286454|FG003|Participant Flow|Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046639|NCT01286454|FG004|Participant Flow|Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046640|NCT01286454|FG005|Participant Flow|Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046641|NCT01286454|FG006|Participant Flow|Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046642|NCT01286454|FG007|Participant Flow|Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11066709|NCT01393717|FG000|Participant Flow|Cohort #1|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
11046643|NCT01286454|FG008|Participant Flow|Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046644|NCT01286454|FG009|Participant Flow|Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
11046645|NCT01286454|FG010|Participant Flow|Fesoterodine 4 mg 10% ER Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.
11046646|NCT01286454|OG000|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
11046647|NCT01286454|OG001|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
11046648|NCT01286454|OG002|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
11046649|NCT01286454|OG003|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
11046650|NCT01286454|OG004|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
11046651|NCT01286454|OG005|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
11046652|NCT01286454|EG000|Reported Event|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
11046653|NCT01286454|EG001|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
11046654|NCT01286454|EG002|Reported Event|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
11046655|NCT01286454|EG003|Reported Event|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
11046656|NCT01286454|EG004|Reported Event|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
11046657|NCT01286454|EG005|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
11046658|NCT01286480|BG000|Baseline|Clinic-based Educational Intervention|Clinic-based Educational Intervention: This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
11046659|NCT01286480|BG001|Baseline|Usual Care|Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
11046660|NCT01286480|BG002|Baseline|Total|Total of all reporting groups
11046661|NCT01286480|FG000|Participant Flow|Intervention Arm|The intervention was conducted by one of three experienced cardiology nurses following intervention-facilitation training and fidelity assurance. The intervention involved a meeting with the nurse and the participant, with the exception of three interventions also attended by a father (n=1), an uncle (n=1) and a participant's friend (n=1). Interventions were held in a quiet room without other distractions, a short walk from the cardiology clinic. The order of the intervention was consistently followed, and the study nurse completed a log and field notes to document any difficulties that were encountered during the intervention and the participant's reaction, level of engagement, questions and body language. Interventions were offered on the same day as a routine clinic visit, or at a later date, depending on the participant's preference.
11046662|NCT01286480|FG001|Participant Flow|Usual Care|Participants allocated to the usual care group were unaware of the intervention being offered to the treatment group. This was intended to prevent contamination by self-education or other means.
11066710|NCT01393717|FG001|Participant Flow|Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
11046663|NCT01286480|OG000|Outcome|Intervention|This involves a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport is created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists are also reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) are presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
11046664|NCT01286480|OG001|Outcome|Usual Care|Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
11046665|NCT01286480|EG000|Reported Event|Intervention|This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
11046666|NCT01286480|EG001|Reported Event|Usual Care|The youth in the usual care arm see a nurse for vitals. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.
11046667|NCT01286493|BG000|Baseline|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
11046668|NCT01286493|FG000|Participant Flow|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
11046669|NCT01286493|OG000|Outcome|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
11046670|NCT01286493|EG000|Reported Event|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
11046671|NCT01286558|BG000|Baseline|80 mg Telmisartan and 5 mg Amlodipine FDC|
11046672|NCT01286558|BG001|Baseline|40 mg Telmisartan and 5 mg Amlodipine FDC|
11046673|NCT01286558|BG002|Baseline|Total|Total of all reporting groups
11046674|NCT01286558|FG000|Participant Flow|80 mg Telmisartan and 5 mg Amlodipine FDC|
11046675|NCT01286558|FG001|Participant Flow|40 mg Telmisartan and 5 mg Amlodipine FDC|
11046676|NCT01286558|OG000|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
11046677|NCT01286558|OG001|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
11046678|NCT01286558|EG000|Reported Event|80 mg Telmisartan and 5 mg Amlodipine FDC|
11046679|NCT01286558|EG001|Reported Event|40 mg Telmisartan and 5 mg Amlodipine FDC|
11046680|NCT01286740|BG000|Baseline|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
11046681|NCT01286740|FG000|Participant Flow|FTC/RPV/TDF|Participants switched from their existing treatment regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (tenofovir DF; TDF) to the FTC 200 mg/rilpivirine (RPV) 25 mg/TDF 300 mg single-table regimen (STR).
11046682|NCT01286740|OG000|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
11046683|NCT01286740|EG000|Reported Event|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
11046684|NCT01286753|BG000|Baseline|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
11046685|NCT01286753|BG001|Baseline|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
11046686|NCT01286753|BG002|Baseline|Total|Total of all reporting groups
11046687|NCT01286753|FG000|Participant Flow|Tyrosine Kinase Inhibitor (TKI) Naive|Vemurafenib 960 milligrams (mg) orally twice daily in participants naive to any prior systemic TKI therapy.
11046688|NCT01286753|FG001|Participant Flow|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
11046689|NCT01286753|OG000|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
11046690|NCT01286753|OG000|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
11046691|NCT01286753|OG001|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
11046692|NCT01286753|EG000|Reported Event|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
11046693|NCT01286753|EG001|Reported Event|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
11046694|NCT01286779|BG000|Baseline|BAX 326|Participants treated with BAX 326
11226835|NCT02378402|OG002|Outcome|Control Group|"Age- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. We quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data."
11046695|NCT01286779|FG000|Participant Flow|BAX 326|Participants treated with BAX 326
11046696|NCT01286779|OG000|Outcome|BAX 326|Participants treated with BAX 326
11046697|NCT01286779|OG001|Outcome|Standard Prophylaxis|Participants treated with BAX 326 with twice weekly prophylactic infusions of 50 IU/kg
11046698|NCT01286779|OG002|Outcome|Modified Prophylaxis|Participants treated with BAX 326 with prophylactic treatment determined by the investigator. The dose could be increased up to 100 IU/kg if indicated.
11046699|NCT01286779|OG003|Outcome|PK Tailored Prophylaxis|Participants treated with BAX 326 with PK tailored prophylaxis base on participant's individual PK with maximum dose of 120 IU/kg.
11046700|NCT01286779|OG004|Outcome|Overall Prophylaxis|All participants who received BAX 326 as prophylactic regimen (standard prophylaxis, modified prophylaxis and PK-tailored prophylaxis)
11046701|NCT01286779|OG005|Outcome|On-Demand|All participants who received BAX 326 as on-demand regimen.
11046702|NCT01286779|OG000|Outcome|Standard Prophylaxis|Participants treated with BAX 326 with twice weekly prophylactic infusions of 50 IU/kg
11046703|NCT01286779|OG001|Outcome|Modified Prophylaxis|Participants treated with BAX 326 with prophylactic treatment determined by the investigator. The dose could be increased up to 100 IU/kg if indicated.
11046704|NCT01286779|OG002|Outcome|PK Tailored Prophylaxis|Participants treated with BAX 326 with PK tailored prophylaxis base on participant's individual PK with maximum dose of 120 IU/kg.
11046705|NCT01286779|OG003|Outcome|Overall Prophylaxis|All participants who received BAX 326 as prophylactic regimen (standard prophylaxis, modified prophylaxis and PK-tailored prophylaxis)
11046706|NCT01286779|OG004|Outcome|On-Demand|All participants who received BAX 326 as on-demand regimen.
11046707|NCT01286779|EG000|Reported Event|BAX 326|Participants treated with BAX 326
11046708|NCT01286805|BG000|Baseline|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
11046709|NCT01286805|BG001|Baseline|Control Group|The control group received only a combined spinal-epidural.
11046710|NCT01286805|BG002|Baseline|Total|Total of all reporting groups
11046711|NCT01286805|FG000|Participant Flow|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
11046712|NCT01286805|FG001|Participant Flow|Control Group|The control group received only a combined spinal-epidural.
11046713|NCT01286805|OG000|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
11046714|NCT01286805|OG001|Outcome|Control Group|The control group received only a combined spinal-epidural.
11046715|NCT01286805|EG000|Reported Event|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
11046716|NCT01286805|EG001|Reported Event|Control Group|The control group received only a combined spinal-epidural.
11046717|NCT01286818|BG000|Baseline|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
11046718|NCT01286818|FG000|Participant Flow|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
11066711|NCT01393717|OG000|Outcome|Patients Receive Brentuximab Vedotin|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
11066712|NCT01393717|OG000|Outcome|Patients in Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
11066713|NCT01393717|OG000|Outcome|Cohort #1|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
11046719|NCT01286818|OG000|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
11046720|NCT01286818|EG000|Reported Event|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
11046721|NCT01286870|BG000|Baseline|Reconstruction|"The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.~The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort."
11046722|NCT01286870|FG000|Participant Flow|Reconstruction|"The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.~The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort."
11046723|NCT01286870|OG000|Outcome|Reconstruction|"The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.~The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort."
11046724|NCT01286870|EG000|Reported Event|Reconstruction|"The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.~The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort."
11046725|NCT01286987|BG000|Baseline|Part 1: Talazoparib 25 mcg/Day|Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046726|NCT01286987|BG001|Baseline|Part 1: Talazoparib 50 mcg/Day|Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046727|NCT01286987|BG002|Baseline|Part 1: Talazoparib 100 mcg/Day|Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046728|NCT01286987|BG003|Baseline|Part 1: Talazoparib 200 mcg/Day|Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046729|NCT01286987|BG004|Baseline|Part 1: Talazoparib 400 mcg/Day|Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046730|NCT01286987|BG005|Baseline|Part 1: Talazoparib 600 mcg/Day|Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046731|NCT01286987|BG006|Baseline|Part 1: Talazoparib 900 mcg/Day|Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046732|NCT01286987|BG007|Baseline|Part 1: Talazoparib 1000 mcg/Day|Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046733|NCT01286987|BG008|Baseline|Part 1: Talazoparib 1100 mcg/Day|Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046734|NCT01286987|BG009|Baseline|Part 2: Talazoparib (Breast Cancer)|Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046735|NCT01286987|BG010|Baseline|Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)|Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046736|NCT01286987|BG011|Baseline|Part 2: Talazoparib (Pancreatic Cancer)|Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046737|NCT01286987|BG012|Baseline|Part 2: Talazoparib (Ewing Cancer)|Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046738|NCT01286987|BG013|Baseline|Part 2: Talazoparib (SCLC Cancer)|Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046739|NCT01286987|BG014|Baseline|Part 2: Talazoparib (Prostate Cancer)|Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046740|NCT01286987|BG015|Baseline|Total|Total of all reporting groups
11046741|NCT01286987|FG000|Participant Flow|Part 1: Talazoparib 25 mcg/Day|Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046742|NCT01286987|FG001|Participant Flow|Part 1: Talazoparib 50 mcg/Day|Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046743|NCT01286987|FG002|Participant Flow|Part 1: Talazoparib 100 mcg/Day|Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046744|NCT01286987|FG003|Participant Flow|Part 1: Talazoparib 200 mcg/Day|Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046745|NCT01286987|FG004|Participant Flow|Part 1: Talazoparib 400 mcg/Day|Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046746|NCT01286987|FG005|Participant Flow|Part 1: Talazoparib 600 mcg/Day|Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046747|NCT01286987|FG006|Participant Flow|Part 1: Talazoparib 900 mcg/Day|Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046748|NCT01286987|FG007|Participant Flow|Part 1: Talazoparib 1000 mcg/Day|Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046749|NCT01286987|FG008|Participant Flow|Part 1: Talazoparib 1100 mcg/Day|Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046750|NCT01286987|FG009|Participant Flow|Part 2: Talazoparib (Breast Cancer)|Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046751|NCT01286987|FG010|Participant Flow|Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)|Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046752|NCT01286987|FG011|Participant Flow|Part 2: Talazoparib (Pancreatic Cancer)|Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046753|NCT01286987|FG012|Participant Flow|Part 2: Talazoparib (Ewing Cancer)|Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046754|NCT01286987|FG013|Participant Flow|Part 2: Talazoparib (SCLC Cancer)|Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046755|NCT01286987|FG014|Participant Flow|Part 2: Talazoparib (Prostate Cancer)|Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046756|NCT01286987|OG000|Outcome|Part 1 and Part 2: Talazoparib (Breast Cancer)|Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
11046757|NCT01286987|OG001|Outcome|Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)|Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
11046758|NCT01286987|OG002|Outcome|Part 1 and Part 2: Talazoparib (Pancreatic Cancer)|Participants with pancreatic cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 1000 mcg/day.
11046759|NCT01286987|OG003|Outcome|Part 1 and Part 2: Talazoparib (Ewing Cancer)|Participants with ewing cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 1000 mcg/day, 1100 mcg/day.
11046760|NCT01286987|OG004|Outcome|Part 2: Talazoparib (SCLC Cancer)|Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
10887277|NCT00499616|BG003|Baseline|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.~Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
11046761|NCT01286987|OG005|Outcome|Part 1 and Part 2: Talazoparib (Prostate Cancer)|Participants with prostate cancer who received talazoparib capsules in Part 1 and 2 at a dose of 600 mcg/day.
11046762|NCT01286987|OG006|Outcome|Part 1: Talazoparib (Colorectal Cancer)|Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
11046763|NCT01286987|OG000|Outcome|Part 1: Talazoparib: All Participants|All participants who received talazoparib capsules in part 1 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day and 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046764|NCT01286987|OG000|Outcome|Part 1: Talazoparib 25 mcg/Day|Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046765|NCT01286987|OG001|Outcome|Part 1: Talazoparib 50 mcg/Day|Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046766|NCT01286987|OG002|Outcome|Part 1: Talazoparib 100 mcg/Day|Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046767|NCT01286987|OG003|Outcome|Part 1: Talazoparib 200 mcg/Day|Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046768|NCT01286987|OG004|Outcome|Part 1: Talazoparib 400 mcg/Day|Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11066714|NCT01393717|OG001|Outcome|Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
10887278|NCT00499616|BG004|Baseline|Total|Total of all reporting groups
11046769|NCT01286987|OG005|Outcome|Part 1: Talazoparib 600 mcg/Day|Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046770|NCT01286987|OG006|Outcome|Part 1: Talazoparib 900 mcg/Day|Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046771|NCT01286987|OG007|Outcome|Part 1: Talazoparib 1000 mcg/Day|Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046772|NCT01286987|OG008|Outcome|Part 1: Talazoparib 1100 mcg/Day|Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046773|NCT01286987|OG009|Outcome|Part 2: Talazoparib (Breast Cancer)|Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046774|NCT01286987|OG010|Outcome|Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)|Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046775|NCT01286987|OG011|Outcome|Part 2: Talazoparib (Pancreatic Cancer)|Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046776|NCT01286987|OG012|Outcome|Part 2: Talazoparib (Ewing Cancer)|Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046777|NCT01286987|OG013|Outcome|Part 2: Talazoparib (SCLC Cancer)|Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
11046778|NCT01286987|OG014|Outcome|Part 2: Talazoparib (Prostate Cancer)|Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046779|NCT01286987|OG000|Outcome|Part 2: Talazoparib 1000 mcg|All participants with either breast, ovarian/peritoneal, pancreatic, ewing, SCLC, or prostate cancer who received talazoparib capsules at a dose of 1000 mcg/day in Part 2.
11046780|NCT01286987|EG000|Reported Event|Part 1: Talazoparib 25 mcg/Day|Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046781|NCT01286987|EG001|Reported Event|Part 1: Talazoparib 50 mcg/Day|Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046782|NCT01286987|EG002|Reported Event|Part 1: Talazoparib 100 mcg/Day|Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046783|NCT01286987|EG003|Reported Event|Part 1: Talazoparib 200 mcg/Day|Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046784|NCT01286987|EG004|Reported Event|Part 1: Talazoparib 400 mcg/Day|Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046785|NCT01286987|EG005|Reported Event|Part 1: Talazoparib 600 mcg/Day|Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046786|NCT01286987|EG006|Reported Event|Part 1: Talazoparib 900 mcg/Day|Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046787|NCT01286987|EG007|Reported Event|Part 1: Talazoparib 1000 mcg/Day|Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11066715|NCT01393717|OG000|Outcome|Patients With BV Followed by AutoHCT|Patients that received brentuximab vedotin followed by autologous transplants.
11046788|NCT01286987|EG008|Reported Event|Part 1: Talazoparib 1100 mcg/Day|Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046789|NCT01286987|EG009|Reported Event|Part 2: Talazoparib (Breast Cancer)|Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046790|NCT01286987|EG010|Reported Event|Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)|Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046791|NCT01286987|EG011|Reported Event|Part 2: Talazoparib (Pancreatic Cancer)|Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046792|NCT01286987|EG012|Reported Event|Part 2: Talazoparib (Ewing Cancer)|Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046793|NCT01286987|EG013|Reported Event|Part 2: Talazoparib (SCLC Cancer)|Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046794|NCT01286987|EG014|Reported Event|Part 2: Talazoparib (Prostate Cancer)|Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
11046795|NCT01287013|BG000|Baseline|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
11046796|NCT01287013|BG001|Baseline|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
11046797|NCT01287013|BG002|Baseline|PILOT|Procedures performed with Xperguide without randomization to familiarize operators.
11046798|NCT01287013|BG003|Baseline|Total|Total of all reporting groups
11046799|NCT01287013|FG000|Participant Flow|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
11046800|NCT01287013|FG001|Participant Flow|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
11046801|NCT01287013|FG002|Participant Flow|PILOT|Procedures performed with Xperguide without randomization to familiarize operators.
11046802|NCT01287013|OG000|Outcome|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
11046803|NCT01287013|OG001|Outcome|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
11046804|NCT01287013|OG001|Outcome|Convetional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
11046805|NCT01287013|EG000|Reported Event|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
11046806|NCT01287013|EG001|Reported Event|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
11046807|NCT01287013|EG002|Reported Event|Pilot Arm|Pilot participants were enrolled to familiarize operators with performing Xperguide procedures.
11046808|NCT01287039|BG000|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046809|NCT01287039|BG001|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046810|NCT01287039|BG002|Baseline|Total|Total of all reporting groups
11046811|NCT01287039|FG000|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046812|NCT01287039|FG001|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046813|NCT01287039|OG000|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046814|NCT01287039|OG001|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046815|NCT01287039|EG000|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046816|NCT01287039|EG001|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
11046817|NCT01287065|BG000|Baseline|Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM in 1 of 6 Seq|All participants received one of the following three treatments in one of three treatment periods from the Dry Powder Inhaler (DPI) for 14 days: placebo in the morning (AM) and evening (PM), Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM, and FF/VI inhalation powder 100/25 µg PM and placebo AM. Participants were randomized to receive treatment in one of the six following sequences (seq): (1) placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM; (2) placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM; (3) FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, placebo; (4) FF/VI 100/25 µg AM, placebo, FF/VI 100/25 µg PM; (5) FF/VI 100/25 µg PM, placebo, FF/VI 100/25 µg AM; (6) FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, placebo. Each 14 day treatment period was followed by a 14-21 day washout period.
11066716|NCT01393717|OG000|Outcome|Patients Received BV Followed by AutoHCT|Patients that received brentuximab (BV) vedotin followed by autologous transplants
11046818|NCT01287065|FG000|Participant Flow|Sequence 1: Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM|Participants received placebo, Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) AM, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
11046819|NCT01287065|FG001|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM|Participants received placebo, FF/VI 100/25 µg PM, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
11046820|NCT01287065|FG002|Participant Flow|Sequence 3: FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, Placebo|Participants received FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
11046821|NCT01287065|FG003|Participant Flow|Sequence 4: FF/VI 100/25 µg AM, Placebo, FF/VI 100/25 µg PM|Participants received FF/VI 100/25 µg AM, placebo, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
11046822|NCT01287065|FG004|Participant Flow|Sequence 5: FF/VI 100/25 µg PM, Placebo, FF/VI 100/25 µg AM|Participants received FF/VI 100/25 µg PM, placebo, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
11046823|NCT01287065|FG005|Participant Flow|Sequence 6: FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, Placebo|Participants received FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
11046824|NCT01287065|OG000|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
11046825|NCT01287065|OG001|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
11046826|NCT01287065|OG002|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
11046827|NCT01287065|EG000|Reported Event|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
11046828|NCT01287065|EG001|Reported Event|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
11046829|NCT01287065|EG002|Reported Event|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
11046830|NCT01287078|BG000|Baseline|Inhaled Cyclosporine in HSCT Recipients|Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
11046831|NCT01287078|BG001|Baseline|Inhaled Cyclosporine in Lung Transplant Recipients|Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
11046832|NCT01287078|BG002|Baseline|Total|Total of all reporting groups
11046833|NCT01287078|FG000|Participant Flow|Inhaled Cyclosporine in HSCT Recipients|Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
11046834|NCT01287078|FG001|Participant Flow|Inhaled Cyclosporine in Lung Transplant Recipients|Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
11046835|NCT01287078|OG000|Outcome|Inhaled Cyclosporine in HSCT Recipients|Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
11046836|NCT01287078|OG001|Outcome|Inhaled Cyclosporine in Lung Transplant Recipients|Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
11046837|NCT01287078|EG000|Reported Event|Inhaled Cyclosporine in HSCT Recipients|Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
11066717|NCT01393717|EG000|Reported Event|Cohort #1|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
11046838|NCT01287078|EG001|Reported Event|Inhaled Cyclosporine in Lung Transplant Recipients|Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
11046839|NCT01287104|BG000|Baseline|SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046840|NCT01287104|BG001|Baseline|SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^6 NK cells/kg.
11046841|NCT01287104|BG002|Baseline|SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)|All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046842|NCT01287104|BG003|Baseline|SG4 - Related Donors|All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
11046843|NCT01287104|BG004|Baseline|Total|Total of all reporting groups
11046844|NCT01287104|FG000|Participant Flow|SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046845|NCT01287104|FG001|Participant Flow|SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^6 NK cells/kg.
11046846|NCT01287104|FG002|Participant Flow|SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)|All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046847|NCT01287104|FG003|Participant Flow|SG4 - Related Donors|All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
11046848|NCT01287104|OG000|Outcome|SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046849|NCT01287104|OG001|Outcome|SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^6 NK cells/kg.
11046850|NCT01287104|OG002|Outcome|SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)|All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046851|NCT01287104|OG000|Outcome|SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^6 NK cells/kg.
11046852|NCT01287104|OG001|Outcome|SG3 - Patients With Unrelated Donors at Dose Level 1 (1x10^5 c|All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046853|NCT01287104|OG002|Outcome|SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)|All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg..
11046854|NCT01287104|OG000|Outcome|SG1 - Patients With Related Donors|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046855|NCT01287104|OG001|Outcome|SG2 - Patients With Unrelated Donors|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^6 NK cells/kg.
11046856|NCT01287104|OG001|Outcome|SG2 - Patients With Related Donors at DL 2 (1x10^6 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^6 NK cells/kg.
11046857|NCT01287104|OG002|Outcome|SG3 - Patients With Unrelated Donors at Dose Level 1 (1x10^5 c|All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046858|NCT01287104|OG003|Outcome|SG4 - Related Donors|All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
11046859|NCT01287104|EG000|Reported Event|SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046860|NCT01287104|EG001|Reported Event|SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)|All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^6 NK cells/kg.
11046861|NCT01287104|EG002|Reported Event|SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)|All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10^5 NK cells/kg.
11046862|NCT01287104|EG003|Reported Event|SG4 - Related Donors|All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
11046863|NCT01287117|BG000|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
11046864|NCT01287117|BG001|Baseline|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046865|NCT01287117|BG002|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046866|NCT01287117|BG003|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046867|NCT01287117|BG004|Baseline|Total|Total of all reporting groups
11046868|NCT01287117|FG000|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
11046869|NCT01287117|FG001|Participant Flow|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046870|NCT01287117|FG002|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046871|NCT01287117|FG003|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046872|NCT01287117|OG000|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
11046873|NCT01287117|OG001|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046874|NCT01287117|OG002|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046875|NCT01287117|OG003|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046876|NCT01287117|EG000|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
11046877|NCT01287117|EG001|Reported Event|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046878|NCT01287117|EG002|Reported Event|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046879|NCT01287117|EG003|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
11046880|NCT01287195|BG000|Baseline|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
11046881|NCT01287195|FG000|Participant Flow|Oral OKT3|Participants with ulcerative colitis received 1 milligram (mg) Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
11046882|NCT01287195|OG000|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
11046883|NCT01287195|EG000|Reported Event|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
11046884|NCT01287208|BG000|Baseline|Unblinded|Activity monitor with visible and on-line feedback
11046885|NCT01287208|BG001|Baseline|Blinded|Activity monitor with no feedback
11046886|NCT01287208|BG002|Baseline|Total|Total of all reporting groups
11046887|NCT01287208|FG000|Participant Flow|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
11046888|NCT01287208|FG001|Participant Flow|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
11046889|NCT01287208|OG000|Outcome|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
11046890|NCT01287208|OG001|Outcome|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
11046891|NCT01287208|OG000|Outcome|Unblinded|"Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.~Activity monitor: The activity monitor is an accelerometer that records steps, distance, calories, and sleep"
11046892|NCT01287208|OG001|Outcome|Blinded|"Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.~Activity device: Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject"
11046893|NCT01287208|EG000|Reported Event|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
11046894|NCT01287208|EG001|Reported Event|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
11046895|NCT01287221|BG000|Baseline|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
11046896|NCT01287221|BG001|Baseline|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
11046897|NCT01287221|BG002|Baseline|Total|Total of all reporting groups
11046898|NCT01287221|FG000|Participant Flow|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
11046899|NCT01287221|FG001|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
11046900|NCT01287221|OG000|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
11046901|NCT01287221|OG001|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
11046902|NCT01287221|EG000|Reported Event|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
11046903|NCT01287221|EG001|Reported Event|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
11046904|NCT01287364|BG000|Baseline|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
11046905|NCT01287364|BG001|Baseline|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
11046906|NCT01287364|BG002|Baseline|Total|Total of all reporting groups
11046907|NCT01287364|FG000|Participant Flow|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
11046908|NCT01287364|FG001|Participant Flow|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
11046909|NCT01287364|OG000|Outcome|Average Cronbach's Alpha (Raw) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
11046910|NCT01287364|OG001|Outcome|Average Cronbach's Alpha (Standardized) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
11046911|NCT01287364|OG000|Outcome|Low Symptoms|Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
11046912|NCT01287364|OG001|Outcome|Medium Symptoms|Patients were assigned to baseline rTNSS categories of Medium Symptoms (7.25 - 9.25; n = 61). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
11046913|NCT01287364|OG002|Outcome|High Symptoms|Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
11046914|NCT01287364|OG000|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
11046915|NCT01287364|OG001|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
11046916|NCT01287364|OG002|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
11046917|NCT01287364|OG001|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups.
11046918|NCT01287364|OG002|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups..
11046919|NCT01287364|OG000|Outcome|Low Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
11046920|NCT01287364|OG001|Outcome|High Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
11046921|NCT01287364|OG002|Outcome|High Minus Low Response Group|Between Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
11046922|NCT01287364|OG000|Outcome|Treatment Process|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Process Component reflects preference on items pertaining to the perceived drug treatment process, including ease of use; convenience; flexibility in daily activities; taste; use in public; smell; fewer problems with medication running out of the nose; fewer problems with medication dripping down throat; and number of sprays per dose.
11046923|NCT01287364|OG001|Outcome|Treatment Outcomes|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Outcomes Component reflects the perceived outcomes of drug treatment, including longer relief; symptom relief, if both were the same price; for feeling better about your appearance; for fewer problems with irritation to nose; faster relief; and how it makes your nose feel.
11046924|NCT01287364|EG000|Reported Event|Ciclesonide|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily pooled
11046925|NCT01287364|EG001|Reported Event|Mometasone|mometasone nasal inhalation 200 μg once daily pooled
11046926|NCT01287377|BG000|Baseline|Pre-Patch and Telephone Counseling|"Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.~Counseling includes a comprehensive pre-quit session and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date."
11046927|NCT01287377|BG001|Baseline|Post-Patch and Telephone Counseling|"Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.~Counseling includes a comprehensive pre-quit session and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date."
11046928|NCT01287377|BG002|Baseline|Telephone Counseling and no Patches Sent|"Counseling includes a comprehensive pre-quit session and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.~Patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches."
11046929|NCT01287377|BG003|Baseline|Total|Total of all reporting groups
11046930|NCT01287377|FG000|Participant Flow|Pre-Patch and Telephone Counseling|"2-weeks of nicotine patches mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.~Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.~Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to st"
11046931|NCT01287377|FG001|Participant Flow|Post-Patch and Telephone Counseling|"2-weeks of nicotine patches mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.~Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.~Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start usi"
11046932|NCT01287377|FG002|Participant Flow|Telephone Counseling and no Patches Sent|"Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date."
11046933|NCT01287377|OG000|Outcome|Pre-Patch and Telephone Counseling|"2-weeks of nicotine patches mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.~Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.~Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to st"
11066718|NCT01393717|EG001|Reported Event|Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
11066719|NCT01393730|BG000|Baseline|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
11046934|NCT01287377|OG001|Outcome|Post-Patch and Telephone Counseling|"2-weeks of nicotine patches mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.~Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.~Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start usi"
11046935|NCT01287377|OG002|Outcome|Telephone Counseling and no Patches Sent|"Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date."
11046936|NCT01287377|EG000|Reported Event|Pre-Patch and Telephone Counseling|"Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.~Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.~s."
11046937|NCT01287377|EG001|Reported Event|Post-Patch and Telephone Counseling|"Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.~Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date."
11046938|NCT01287377|EG002|Reported Event|Telephone Counseling and no Patches Sent|"Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.~Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date."
11046939|NCT01287403|BG000|Baseline|Entire Study Population|Includes groups randomized to receive either esterase wholegrain wheat flour first or liquid wholegrain wheat flour first or liquid wholegrain barley flour first or refined wheat flour first or wholegrain wheat flour first or wholegrain barley flour first
11046940|NCT01287403|FG000|Participant Flow|Six Products (Flours) Assigned Randomly (Cross Over)|"In a crossover design, all subjects were administered the 6 following products in a randomized order:~Esterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids).~Refined wheat flour: a treated cereal flour mixed with milk (negative control).~Liquid whole grain wheat flour: a treated cereal flour mixed with milk.~Liquid wholegrain barley flour: a treated cereal flour mixed with milk.~Wholegrain wheat flour: a treated cereal flour mixed with milk.~Wholegrain barley flour: a treated cereal flour mixed with milk."
11046941|NCT01287403|OG000|Outcome|Esterase Whole Grain Wheat Flour|A cereal flour treated with esterase to release phenolics (positive control for phenolic acids).
11046942|NCT01287403|OG001|Outcome|Refined Wheat Flour|A treated cereal flour mixed with milk(negative control).
11046943|NCT01287403|OG002|Outcome|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
11046944|NCT01287403|OG003|Outcome|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
11046945|NCT01287403|OG004|Outcome|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
11046946|NCT01287403|OG005|Outcome|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
11046947|NCT01287403|EG000|Reported Event|Refined Wheat Flour|A treated cereal flour mixed with milk (negative control).
11046948|NCT01287403|EG001|Reported Event|Esterase Wholegrain Wheat Flour|A cereal flour treated with esterases to release phenolics (positive control for phenolic acids)
11046949|NCT01287403|EG002|Reported Event|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
11046950|NCT01287403|EG003|Reported Event|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
11046951|NCT01287403|EG004|Reported Event|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
11046952|NCT01287403|EG005|Reported Event|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
11046953|NCT01287416|BG000|Baseline|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
11046954|NCT01287416|BG001|Baseline|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity-focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities-explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
11046955|NCT01287416|BG002|Baseline|Total|Total of all reporting groups
11046956|NCT01287416|FG000|Participant Flow|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
11046957|NCT01287416|FG001|Participant Flow|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity-focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities-explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
11046958|NCT01287416|OG000|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
11046959|NCT01287416|OG001|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity-focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities-explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
11046960|NCT01287416|EG000|Reported Event|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
11046961|NCT01287416|EG001|Reported Event|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity-focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities-explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
11046962|NCT01287520|BG000|Baseline|LY 10/Carb 5/Pem 500 (Cohort 1)|"Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11046963|NCT01287520|BG001|Baseline|LY 10/Carb 6/Pem 500 (Cohort 2)|"Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11046964|NCT01287520|BG002|Baseline|LY 20/Carb 6/Pem 500 (Cohort 3)|"Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion."
11046965|NCT01287520|BG003|Baseline|LY 40/Carb 6/Pem 500 (Cohort 4)|"Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion."
11046966|NCT01287520|BG004|Baseline|LY 80/Carb 6/Pem 500 (Cohort 5)|"Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion."
11046967|NCT01287520|BG005|Baseline|LY 120/Carb 6/Pem 500 (Cohort 6)|"Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion."
11046968|NCT01287520|BG006|Baseline|LY 80/Carb 6/Pem 500 + R50 (Cohort 7)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046969|NCT01287520|BG007|Baseline|LY 60/Carb 6/Pem 500 + R50 (Cohort 8)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046970|NCT01287520|BG008|Baseline|LY 40/Carb 6/Pem 500 + R50 (Cohort 9)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046971|NCT01287520|BG009|Baseline|Total|Total of all reporting groups
11046972|NCT01287520|FG000|Participant Flow|LY 10/Carb 5/Pem 500 (Cohort 1)|"Cycle 1 Day 1 of 28-day cycle: 10 milligrams (mg) LY2090314 (LY) administered by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 milligrams per meter squared (mg/m^2) pemetrexed (Pem) administered by intravenous infusion followed by Area Under the Time Curve (AUC) 5 milligrams per milliliter times minutes (mg/mL * min) carboplatin (Carb) administered by intravenous infusion.~Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL * min Carb administered by intravenous infusion followed by 10 mg LY2090314 administered by intravenous infusion."
11046973|NCT01287520|FG001|Participant Flow|LY 10/Carb 6/Pem 500 (Cohort 2)|"Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11046974|NCT01287520|FG002|Participant Flow|LY 20/Carb 6/Pem 500 (Cohort 3)|"Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion."
11046975|NCT01287520|FG003|Participant Flow|LY 40/Carb 6/Pem 500 (Cohort 4)|"Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 and beyond: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion."
11066720|NCT01393730|FG000|Participant Flow|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
11046976|NCT01287520|FG004|Participant Flow|LY 80/Carb 6/Pem 500 (Cohort 5)|"Cycle 1 Day 1 of 28 -ay cycle: 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up and beyond: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion"
11046977|NCT01287520|FG005|Participant Flow|LY 120/Carb 6/Pem 500 -(Cohort 6)|"Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion."
11046978|NCT01287520|FG006|Participant Flow|LY 80/Carb 6/Pem 500 + R50 (Cohort 7)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine (R50) intravenous, 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem IV infusion.~Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046979|NCT01287520|FG007|Participant Flow|LY 60/Carb 6/Pem 500 + R50 (Cohort 8)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by IV infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046980|NCT01287520|FG008|Participant Flow|LY 40/Carb 6/Pem 500 + R50 (Cohort 9)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine IV pretreatment and 40 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046981|NCT01287520|OG000|Outcome|LY2090314/Pemetrexed/Carboplatin|"Cycle 1 (28 days)~Cohorts 1 to 3~Cycle 1 Day 1: 10-20 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or 6 mg/mL * min Carb by intravenous infusion.~Cohorts 4 to 9, Cohorts 7 to 9 were pretreated with 50 mg ranitidine intravenous-Cycle 1 Day 1: 40-120 mg LY2090314 by intravenous infusion.~-Cycle 1 Day 8: 500 mg/m^2 by Pem intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40-120 mg LY2090314 by intravenous infusion."
11046982|NCT01287520|OG000|Outcome|LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)|"Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11046983|NCT01287520|OG001|Outcome|LY 20/Carb 6/Pem 500 (Cohort 3)|"Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion."
11046984|NCT01287520|OG002|Outcome|LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)|"Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion-followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 49 mg LY2090314 by intravenous infusion.~Cohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.~Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11066721|NCT01393730|OG000|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
11066722|NCT01393730|EG000|Reported Event|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
11226425|NCT02374463|FG000|Participant Flow|MMBI|Multimodality Balance Intervention (MMBI): The Investigator's MMBI class will be held 3-times a week for an hour and will consist of a group dynamic balance class (30 minutes), a supervised obstacle course (10 minutes), and lower extremity and core strengthening (20 minutes). The group exercise classes will focus on dynamic weight shifts with an emphasis on the lateral and diagonal directions. Over the 6 months of class, the exercises will gradually increase in difficulty to challenge balance. A skilled instructor will lead each class and 1-2 assistants will be present to assist with fall risk prevention. The supervised obstacle course will focus on obstacle negotiation, gait over challenging surfaces, and moving in lateral, diagonal, and backward directions. Finally, strength training of the lower extremities and core will focus on strengthening major muscles of the lower extremity and core utilizing commonly available gym equipment, ankle weights and body weight.
11046985|NCT01287520|OG003|Outcome|LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)|"Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cohort 7, LY2090314 pretreated with 50 mg ranitidine intravenous.~Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046986|NCT01287520|OG004|Outcome|LY 120/Carb 6/Pem 500 (Cohort 6)|"Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 by Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion."
11046987|NCT01287520|OG005|Outcome|LY 60/Carb 6/Pem 500 + R50 (Cohort 8)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046988|NCT01287520|OG002|Outcome|LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)|"Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.~Based on I2H-MC-JWYa Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046989|NCT01287520|OG003|Outcome|LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)|"Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cohort 7, LY2090314 pretreated with 50 mg ranitidine intravenous.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046990|NCT01287520|OG001|Outcome|LY 20/Carb 6/Pem 500 (Cohort 3)|"Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by LY2090314 20 mg by intravenous infusion."
11046991|NCT01287520|OG002|Outcome|LY 40/Carb 6/Pem 500 (Cohorts 4 and 9 )|"Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 49 mg LY2090314 by intravenous infusion.~Cohort 9, LY2090314 pretreated with 50 mg ranitidine IV. Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046992|NCT01287520|OG003|Outcome|LY 80/Carb 6/Pem 500 (Cohorts 5 and 7|"Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cohort 7, LY2090314 pretreated with 50 mg ranitidine IV.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11066723|NCT01393743|BG000|Baseline|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
11046993|NCT01287520|OG005|Outcome|LY 60/Carb 6/Pem 500 + R50 (Cohort 8)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by IV infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046994|NCT01287520|OG002|Outcome|LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)|"Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046995|NCT01287520|OG003|Outcome|LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)|"Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cohort 7, LY2090314 pretreated with 50 mg ranitidine IV.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046996|NCT01287520|OG005|Outcome|LY 60/Carb 6/Pem 500 + R50 (Cohort 8)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.~Based on I2H-MC_JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11046997|NCT01287520|OG000|Outcome|LY 10/Carb 5/Pem 500 (Cohort 1)|"Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11046998|NCT01287520|OG001|Outcome|LY 10/Carb 6/Pem 500 (Cohort 2)|"Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11046999|NCT01287520|OG002|Outcome|LY 20/Carb 6/Pem 500 (Cohort 3)|"Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion."
11047000|NCT01287520|OG003|Outcome|LY 40/Carb 6/Pem 500 (Cohort 4)|"Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion."
11047001|NCT01287520|OG004|Outcome|LY 80/Carb 6/Pem 500 (Cohort 5)|"Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion."
11047002|NCT01287520|OG005|Outcome|LY 120/Carb 6/Pem 500 (Cohort 6)|"Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion."
11066724|NCT01393743|BG001|Baseline|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
11066725|NCT01393743|BG002|Baseline|Total|Total of all reporting groups
11066726|NCT01393743|FG000|Participant Flow|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
11047003|NCT01287520|OG006|Outcome|LY 80/Carb 6/Pem 500 + R50 (Cohort 7)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 IV infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047004|NCT01287520|OG007|Outcome|LY 60/Carb 6/Pem 500 + R50 (Cohort 8)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047005|NCT01287520|OG008|Outcome|LY 40/Carb 6/Pem 500 + R50 (Cohort 9)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 intravenous Pem infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min by Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047006|NCT01287520|OG000|Outcome|Pemetrexed (Doublet Therapy)|"Pem with Carb~Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem and AUC 5 or AUC 6 mg/mL * min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.~Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle"
11047007|NCT01287520|OG001|Outcome|Pemetrexed (Triplet Therapy)|"Pem with Carb and LY2090314~Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 10: Day 1 of 21-day cycle.~Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.~Based on I2H-MC-JWYA Protocol Amendment (D) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9."
11047008|NCT01287520|OG001|Outcome|Pemetrexed (Triplet Therapy)|"Pem with Carb and LY2090317~Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 10: Day 1 of 21-day cycle.~Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9."
11047009|NCT01287520|OG000|Outcome|Carboplatin (Doublet Therapy)|"Carb and Pem~Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem and AUC 5 or AUC 6 mg/mL * min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.~Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle"
11047010|NCT01287520|OG001|Outcome|Carboplatin (Triplet Therapy)|"Carb with Pem and LY2090314~Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 9: Day 1 of 21-day cycle.~Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 9: Day 1 of 21-day cycle.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9."
11047011|NCT01287520|OG001|Outcome|Carboplatin (Triplet Therapy)|"Carb and Pem with LY2090314~Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 9: Day 1 of 21-day cycle.~Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9."
11047012|NCT01287520|OG000|Outcome|LY 10/Carb 5/Pem 500 (Cohort 1)|"Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by IV infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11047013|NCT01287520|OG001|Outcome|LY 10/Carb 6/Pem 500 (Cohort 2)|"Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by IV infusion.~Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11047014|NCT01287520|OG002|Outcome|LY 20/Carb 6/Pem 500 (Cohort 3)|"Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 -ay cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion."
11047015|NCT01287520|OG005|Outcome|LY 120/Carb 6/Pem 500 (Cohort 6)|"Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 mg by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion."
11047016|NCT01287520|OG006|Outcome|LY 80/Carb 6/Pem 500 + R50 (Cohort 7)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047017|NCT01287520|OG007|Outcome|LY 60/Carb 6/Pem 500 + R50 (Cohort 8)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine IV pretreatment and 60 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047018|NCT01287520|OG008|Outcome|LY 40/Carb 6/Pem 500 + R50 (Cohort 9)|"Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.~Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047019|NCT01287520|EG000|Reported Event|LY 10/Carb 5/Pem 500 (Cohort 1)|"Cycle 1 Day 1 of 28 day cycle: 10 mg LY2090314 administered by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL * min Carb administered by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL * min Carb administered by intravenous infusion followed by 10 mg LY2090314 administered by intravenous infusion."
11047020|NCT01287520|EG001|Reported Event|LY 10/Carb 6/Pem 500 (Cohort 2)|"Cycle 1 Day 1 of 28 day cycle: 10 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 by Pem intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion."
11047021|NCT01287520|EG002|Reported Event|LY 20/Carb 6/Pem 500 (Cohort 3)|"Cycle 1 Day 1 of 28 day cycle: 20 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.~Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion."
11047022|NCT01287520|EG003|Reported Event|LY 40/Carb 6/Pem 500 (Cohort 4)|"Cycle 1 Day 1 of 28 day cycle: 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion."
11047023|NCT01287520|EG004|Reported Event|LY 80/Carb 6/Pem 500 (Cohort 5)|"Cycle 1 Day 1 of 28 day cycle: 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion."
11066727|NCT01393743|FG001|Participant Flow|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
11047024|NCT01287520|EG005|Reported Event|LY 120/Carb 6/Pem 500 (Cohort 6)|"Cycle 1 Day 1 of 28 day cycle: 120 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion."
11047025|NCT01287520|EG006|Reported Event|LY 80/Carb 6/Pem 500 + R50 (Cohort 7)|"Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.~Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047026|NCT01287520|EG007|Reported Event|LY 60/Carb 6/Pem 500 + R50 (Cohort 8)|"Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.~Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.~Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047027|NCT01287520|EG008|Reported Event|LY 40/Carb 6/Pem 500 + R50 (Cohort 9)|"Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.~Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40mmg LY2090314 40 mg by intravenous infusion.~Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.~Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.~Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain."
11047028|NCT01287754|BG000|Baseline|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
11047029|NCT01287754|BG001|Baseline|Untreated|Participants without the EGFR mutation were followed for overall survival but did not undergo treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
11047030|NCT01287754|BG002|Baseline|Total|Total of all reporting groups
11047031|NCT01287754|FG000|Participant Flow|Erlotinib|Participants positive for the epidermal growth factor receptor (EGFR) mutation and who met eligibility criteria received treatment with erlotinib, 150 milligrams (mg) orally once daily until disease progression or unacceptable toxicity.
11047032|NCT01287754|FG001|Participant Flow|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
11047033|NCT01287754|OG000|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
11047034|NCT01287754|OG001|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
11047035|NCT01287754|OG000|Outcome|All Participants|All participants underwent EGFR mutation testing at Screening. Those positive for the EGFR mutation and who met eligibility criteria (n = 3) received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity. The remaining participants (n = 21) were followed for overall survival but did not receive treatment.
11047036|NCT01287754|EG000|Reported Event|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
11047037|NCT01287832|BG000|Baseline|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
11047038|NCT01287832|BG001|Baseline|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
11047039|NCT01287832|BG002|Baseline|Total|Total of all reporting groups
11047040|NCT01287832|FG000|Participant Flow|High Dose Vancomycin|Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
11047041|NCT01287832|FG001|Participant Flow|High-dose Daptomycin|Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
11047042|NCT01287832|OG000|Outcome|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
11047043|NCT01287832|OG001|Outcome|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
11047044|NCT01287832|EG000|Reported Event|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
11047045|NCT01287832|EG001|Reported Event|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
11047046|NCT01287897|BG000|Baseline|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047047|NCT01287897|BG001|Baseline|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047048|NCT01287897|BG002|Baseline|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047049|NCT01287897|BG003|Baseline|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047050|NCT01287897|BG004|Baseline|Total|Total of all reporting groups
11047051|NCT01287897|FG000|Participant Flow|Placebo|Placebo administered subcutaneously (SC) in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047052|NCT01287897|FG001|Participant Flow|PF-04236921 10 Milligram (mg)|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047053|NCT01287897|FG002|Participant Flow|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047054|NCT01287897|FG003|Participant Flow|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047055|NCT01287897|OG000|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047056|NCT01287897|OG001|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047057|NCT01287897|OG002|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047058|NCT01287897|OG001|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047059|NCT01287897|OG000|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047060|NCT01287897|OG001|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047061|NCT01287897|OG002|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047062|NCT01287897|OG003|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047063|NCT01287897|EG000|Reported Event|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047064|NCT01287897|EG001|Reported Event|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047065|NCT01287897|EG002|Reported Event|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047066|NCT01287897|EG003|Reported Event|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
11047067|NCT01288027|BG000|Baseline|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
11047068|NCT01288027|FG000|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
11047069|NCT01288027|OG000|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
11047070|NCT01288027|EG000|Reported Event|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
11047071|NCT01288053|BG000|Baseline|Allogeneic Stem Cell Therapy|"Allogeneic Stem Cell Therapy will be performed after conditioning~Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease"
11047072|NCT01288053|FG000|Participant Flow|Allogeneic Stem Cell Therapy|"Allogeneic Stem Cell Therapy will be performed after conditioning~Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease"
11047073|NCT01288053|OG000|Outcome|Allogeneic Stem Cell Therapy|"Allogeneic Stem Cell Therapy will be performed after conditioning~Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease"
11047074|NCT01288053|EG000|Reported Event|Allogeneic Stem Cell Therapy|"Allogeneic Stem Cell Therapy will be performed after conditioning~Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease"
11047075|NCT01288079|BG000|Baseline|1 mg BID TC-5214|
11047076|NCT01288079|BG001|Baseline|4 mg BID TC-5214|
11047077|NCT01288079|BG002|Baseline|60 mg QD Duloxetine|
11047078|NCT01288079|BG003|Baseline|Placebo|
11047079|NCT01288079|BG004|Baseline|Total|Total of all reporting groups
11047080|NCT01288079|FG000|Participant Flow|1 mg BID TC-5214|
11047081|NCT01288079|FG001|Participant Flow|4 mg BID TC-5214|
11047082|NCT01288079|FG002|Participant Flow|60 mg QD Duloxetine|
11047083|NCT01288079|FG003|Participant Flow|Placebo|
11047084|NCT01288079|OG000|Outcome|1 mg BID TC-5214|
11047085|NCT01288079|OG001|Outcome|4 mg BID TC-5214|
11047086|NCT01288079|OG002|Outcome|60 mg QD Duloxetine|
11047087|NCT01288079|OG003|Outcome|Placebo|
11047088|NCT01288079|EG000|Reported Event|1 mg BID TC-5214|
11047089|NCT01288079|EG001|Reported Event|4 mg BID TC-5214|
11047090|NCT01288079|EG002|Reported Event|60 mg QD Duloxetine|
11047091|NCT01288079|EG003|Reported Event|Placebo|
11047092|NCT01288209|BG000|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
11047093|NCT01288209|BG001|Baseline|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
11047094|NCT01288209|BG002|Baseline|Total|Total of all reporting groups
11047095|NCT01288209|FG000|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
11047096|NCT01288209|FG001|Participant Flow|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
11047097|NCT01288209|OG000|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11047098|NCT01288209|OG001|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11047099|NCT01288209|EG000|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
11047100|NCT01288209|EG001|Reported Event|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
11047101|NCT01288287|BG000|Baseline|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.~Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
11047102|NCT01288287|FG000|Participant Flow|All Patients|Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
11047103|NCT01288287|OG000|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
11047104|NCT01288287|OG001|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
11047105|NCT01288287|EG000|Reported Event|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.~Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
11047106|NCT01288430|BG000|Baseline|Part 1, Cohort 1: DS-2248 0.6 mg/m^2|Participants who received oral DS-2248 0.6 mg/m^2 once daily.
11047107|NCT01288430|BG001|Baseline|Part 1, Cohort 2: DS-2248 1.2 mg/m^2|Participants who received oral DS-2248 1.2 mg/m^2 once daily.
11047108|NCT01288430|BG002|Baseline|Part 1, Cohort 3: DS-2248 1.8 mg/m^2|Participants who received oral DS-2248 1.8 mg/m^2 once daily.
11047109|NCT01288430|BG003|Baseline|Part 1, Cohort 4: DS-2248 2.7 mg/m^2|Participants who received oral DS-2248 2.7 mg/m^2 once daily.
11047110|NCT01288430|BG004|Baseline|Part 1, Cohort 5: DS-2248 3.5 mg/m^2|Participants who received oral DS-2248 3.5 mg/m^2 once daily.
11047111|NCT01288430|BG005|Baseline|Part 1, Cohort 6: DS-2248 4.5 mg/m^2|Participants who received oral DS-2248 4.5 mg/m^2 once daily.
11047112|NCT01288430|BG006|Baseline|Part 1, Cohort 7: DS-2248 5.85 mg/m^2|Participants who received oral DS-2248 5.85 mg/m^2 once daily.
11047113|NCT01288430|BG007|Baseline|Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2|Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m^2 once daily.
11047114|NCT01288430|BG008|Baseline|Part 2, ALK-resistant: DS-2248 4.5 mg/m^2|Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m^2 once daily.
11047115|NCT01288430|BG009|Baseline|Part 2, ALK-naive: DS-2248 4.5 mg/m^2|Participants who were ALK treatment naive and received oral 4.5 mg/m^2 once daily.
11047116|NCT01288430|BG010|Baseline|Total|Total of all reporting groups
11047117|NCT01288430|FG000|Participant Flow|Part 1, Cohort 1: DS-2248 0.6 mg/m^2|Participants who received oral DS-2248 0.6 mg/m^2 once daily.
11047118|NCT01288430|FG001|Participant Flow|Part 1, Cohort 2: DS-2248 1.2 mg/m^2|Participants who received oral DS-2248 1.2 mg/m^2 once daily.
11047119|NCT01288430|FG002|Participant Flow|Part 1, Cohort 3: DS-2248 1.8 mg/m^2|Participants who received oral DS-2248 1.8 mg/m^2 once daily.
11047120|NCT01288430|FG003|Participant Flow|Part 1, Cohort 4: DS-2248 2.7 mg/m^2|Participants who received oral DS-2248 2.7 mg/m^2 once daily.
11047121|NCT01288430|FG004|Participant Flow|Part 1, Cohort 5: DS-2248 3.5 mg/m^2|Participants who received oral DS-2248 3.5 mg/m^2 once daily.
11047122|NCT01288430|FG005|Participant Flow|Part 1, Cohort 6: DS-2248 4.5 mg/m^2|Participants who received oral DS-2248 4.5 mg/m^2 once daily.
11047123|NCT01288430|FG006|Participant Flow|Part 1, Cohort 7: DS-2248 5.85 mg/m^2|Participants who received oral DS-2248 5.85 mg/m^2 once daily.
11047124|NCT01288430|FG007|Participant Flow|Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2|Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m^2 once daily.
11047125|NCT01288430|FG008|Participant Flow|Part 2, ALK-resistant: DS-2248 4.5 mg/m^2|Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m^2 once daily.
11047126|NCT01288430|FG009|Participant Flow|Part 2, ALK-naive: DS-2248 4.5 mg/m^2|Participants who were ALK treatment naive and received oral 4.5 mg/m^2 once daily.
11047127|NCT01288430|OG000|Outcome|Part 1, Cohort 1: DS-2248 0.6 mg/m^2|Participants who received oral DS-2248 0.6 mg/m^2 once daily.
11047128|NCT01288430|OG001|Outcome|Part 1, Cohort 2: DS-2248 1.2 mg/m^2|Participants who received oral DS-2248 1.2 mg/m^2 once daily.
11047129|NCT01288430|OG002|Outcome|Part 1, Cohort 3: DS-2248 1.8 mg/m^2|Participants who received oral DS-2248 1.8 mg/m^2 once daily.
11047130|NCT01288430|OG003|Outcome|Part 1, Cohort 4: DS-2248 2.7 mg/m^2|Participants who received oral DS-2248 2.7 mg/m^2 once daily.
11047131|NCT01288430|OG004|Outcome|Part 1, Cohort 5: DS-2248 3.5 mg/m^2|Participants who received oral DS-2248 3.5 mg/m^2 once daily.
11047132|NCT01288430|OG005|Outcome|Part 1, Cohort 6: DS-2248 4.5 mg/m^2|Participants who received oral DS-2248 4.5 mg/m^2 once daily.
11047133|NCT01288430|OG006|Outcome|Part 1, Cohort 7: DS-2248 5.85 mg/m^2|Participants who received oral DS-2248 5.85 mg/m^2 once daily.
11047134|NCT01288430|OG007|Outcome|Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2|Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m^2 once daily.
11047135|NCT01288430|OG008|Outcome|Part 2, ALK-resistant: DS-2248 4.5 mg/m^2|Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m^2 once daily.
11047136|NCT01288430|OG009|Outcome|Part 2, ALK-naive: DS-2248 4.5 mg/m^2|Participants who were ALK treatment naive and received oral 4.5 mg/m^2 once daily.
11047137|NCT01288430|OG007|Outcome|Total - Part 1|All participants who received oral DS-2248 in Part 1.
11047138|NCT01288430|OG008|Outcome|Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2|Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m^2 once daily.
11047139|NCT01288430|OG009|Outcome|Part 2, ALK-resistant: DS-2248 4.5 mg/m^2|Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m^2 once daily.
11047140|NCT01288430|OG010|Outcome|Part 2, ALK-naive: DS-2248 4.5 mg/m^2|Participants who were ALK treatment naive and received oral 4.5 mg/m^2 once daily.
11047141|NCT01288430|OG011|Outcome|Total - Part 2|All participants who received oral DS-2248 in Part 2.
11047142|NCT01288430|EG000|Reported Event|Part 1, Cohort 1: DS-2248 0.6 mg/m^2|Participants who received oral DS-2248 0.6 mg/m^2 once daily.
11047143|NCT01288430|EG001|Reported Event|Part 1, Cohort 2: DS-2248 1.2 mg/m^2|Participants who received oral DS-2248 1.2 mg/m^2 once daily.
11047144|NCT01288430|EG002|Reported Event|Part 1, Cohort 3: DS-2248 1.8 mg/m^2|Participants who received oral DS-2248 1.8 mg/m^2 once daily.
11047145|NCT01288430|EG003|Reported Event|Part 1, Cohort 4: DS-2248 2.7 mg/m^2|Participants who received oral DS-2248 2.7 mg/m^2 once daily.
11047146|NCT01288430|EG004|Reported Event|Part 1, Cohort 5: DS-2248 3.5 mg/m^2|Participants who received oral DS-2248 3.5 mg/m^2 once daily.
11047147|NCT01288430|EG005|Reported Event|Part 1, Cohort 6: DS-2248 4.5 mg/m^2|Participants who received oral DS-2248 4.5 mg/m^2 once daily.
11047148|NCT01288430|EG006|Reported Event|Part 1, Cohort 7: DS-2248 5.85 mg/m^2|Participants who received oral DS-2248 5.85 mg/m^2 once daily.
11047149|NCT01288430|EG007|Reported Event|Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2|Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m^2 once daily.
11047150|NCT01288430|EG008|Reported Event|Part 2, ALK-resistant: DS-2248 4.5 mg/m^2|Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m^2 once daily.
11047151|NCT01288430|EG009|Reported Event|Part 2, ALK-naive: DS-2248 4.5 mg/m^2|Participants who were ALK treatment naive and received oral 4.5 mg/m^2 once daily.
11047152|NCT01288443|BG000|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047153|NCT01288443|BG001|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047154|NCT01288443|BG002|Baseline|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047155|NCT01288443|BG003|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047156|NCT01288443|BG004|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047157|NCT01288443|BG005|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047158|NCT01288443|BG006|Baseline|Total|Total of all reporting groups
11047159|NCT01288443|FG000|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
11047160|NCT01288443|FG001|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047161|NCT01288443|FG002|Participant Flow|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047162|NCT01288443|FG003|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047163|NCT01288443|FG004|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047164|NCT01288443|FG005|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047165|NCT01288443|OG000|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047166|NCT01288443|OG001|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047167|NCT01288443|OG002|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047168|NCT01288443|OG003|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047169|NCT01288443|OG004|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047170|NCT01288443|OG005|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047171|NCT01288443|EG000|Reported Event|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047172|NCT01288443|EG001|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047173|NCT01288443|EG002|Reported Event|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11348941|NCT04138498|FG001|Participant Flow|Sequence 2 (BACD)|"Subjects in sequence BACD received study treatments in the following order: CTx-1301 6.25 mg tablet, Focalin XR 5 mg capsule, Focalin XR 40 mg capsule, CTx-1301 50 mg tablet.~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation"
11348942|NCT04138498|FG002|Participant Flow|Sequence 3 (CBDA)|"Subjects in sequence CBDA received study treatments in the following order: Focalin XR 40 mg capsule, CTx-1301 6.25 mg tablet, CTx-1301 50 mg tablet, Focalin XR 5 mg capsule.~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation"
11047174|NCT01288443|EG003|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
11047175|NCT01288443|EG004|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047176|NCT01288443|EG005|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
11047177|NCT01288469|BG000|Baseline|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
11047178|NCT01288469|BG001|Baseline|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
11047179|NCT01288469|BG002|Baseline|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
11047180|NCT01288469|BG003|Baseline|Total|Total of all reporting groups
11047181|NCT01288469|FG000|Participant Flow|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
11047182|NCT01288469|FG001|Participant Flow|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
11047183|NCT01288469|FG002|Participant Flow|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
11047184|NCT01288469|OG000|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
11047185|NCT01288469|OG001|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
11047186|NCT01288469|OG002|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
11047187|NCT01288469|EG000|Reported Event|Placebo + Atorvastatin 80mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
11047188|NCT01288469|EG001|Reported Event|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
11047189|NCT01288469|EG002|Reported Event|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
11047190|NCT01288521|BG000|Baseline|Tacrolimus + Ketoconazole, Then Tacrolimus Alone|"Randomized, cross over design~Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
11047191|NCT01288521|BG001|Baseline|Tacrolimus Alone, Then Tacrolimus + Ketoconazole|"Randomized, cross over design~Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
11047192|NCT01288521|BG002|Baseline|Total|Total of all reporting groups
11047193|NCT01288521|FG000|Participant Flow|Tacrolimus + Ketoconazole, Then Tacrolimus Alone|"Randomized, cross over design~Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
11047194|NCT01288521|FG001|Participant Flow|Tacrolimus Alone, Then Tacrolimus + Ketoconazole|"Randomized, cross over design~Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
11047195|NCT01288521|OG000|Outcome|Tacrolimus Alone|"cross over design~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
11047196|NCT01288521|OG001|Outcome|Tacrolimus + Ketoconazole|Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.
11047197|NCT01288521|EG000|Reported Event|Tacrolimus Alone|Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)
11047198|NCT01288521|EG001|Reported Event|Tacrolimus + Ketoconazole|Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.
11047199|NCT01288534|BG000|Baseline|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
11047200|NCT01288534|FG000|Participant Flow|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
11047201|NCT01288534|OG000|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
11047202|NCT01288534|EG000|Reported Event|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
11047203|NCT01288612|BG000|Baseline|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
11047204|NCT01288612|BG001|Baseline|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
11047205|NCT01288612|BG002|Baseline|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
11348943|NCT04138498|FG003|Participant Flow|Sequence 4 (DCAB)|"Subjects in sequence DCAB received study treatments in the following order: CTx-1301 50 mg tablet, Focalin XR 40 mg capsule, Focalin XR 5 mg capsule, CTx-1301 6.25 mg tablet.~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 6.25 mg Tablet: Experimental drug for comparative BA evaluation~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation~Dexmethylphenidate 50 mg Tablet: Experimental drug for comparative BA evaluation"
11047206|NCT01288612|BG003|Baseline|Total|Total of all reporting groups
11047207|NCT01288612|FG000|Participant Flow|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
11047208|NCT01288612|FG001|Participant Flow|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
11047209|NCT01288612|FG002|Participant Flow|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
11047210|NCT01288612|OG000|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
11047211|NCT01288612|OG001|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
11047212|NCT01288612|OG002|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
11047213|NCT01288612|EG000|Reported Event|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
11047214|NCT01288612|EG001|Reported Event|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
11047215|NCT01288612|EG002|Reported Event|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
11047216|NCT01288729|BG000|Baseline|Group 1 - Steel Cathetar, Then Teflon|Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.
11047217|NCT01288729|BG001|Baseline|Group 2 - Teflon Cathetar, the Steel|Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
11047218|NCT01288729|BG002|Baseline|Total|Total of all reporting groups
11047219|NCT01288729|FG000|Participant Flow|Group 1: Steel Cathetar, Then Teflon|Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.
11047220|NCT01288729|FG001|Participant Flow|Group 2 - Teflon Cathetar, the Steel|Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
11047221|NCT01288729|OG000|Outcome|Sure-T Steel Infusion Set Catheter|"Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study)~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
11047222|NCT01288729|OG001|Outcome|Quick-Set Teflon Catheter|"Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study).~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
11047223|NCT01288729|EG000|Reported Event|Sure-T Steel Infusion Set Catheter|"Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study)~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
11047224|NCT01288729|EG001|Reported Event|Quick-Set Teflon Catheter|"Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study).~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
11047225|NCT01288781|BG000|Baseline|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
11047226|NCT01288781|BG001|Baseline|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
11047227|NCT01288781|BG002|Baseline|Total|Total of all reporting groups
11047228|NCT01288781|FG000|Participant Flow|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
11047229|NCT01288781|FG001|Participant Flow|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
11047230|NCT01288781|OG000|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
11047231|NCT01288781|OG001|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
11047232|NCT01288781|EG000|Reported Event|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
11047233|NCT01288781|EG001|Reported Event|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
11047234|NCT01288807|BG000|Baseline|Treatment|"Titrated Milnacipram doses~Milnacipram: Titration to 200mg PO daily"
11047235|NCT01288807|FG000|Participant Flow|Treatment|"Titrated Milnacipram doses~Milnacipram: Titration to 200mg PO daily"
11047236|NCT01288807|OG000|Outcome|Treatment|"Titrated Milnacipram doses~Milnacipram: Titration to 200mg PO daily"
11047237|NCT01288807|EG000|Reported Event|Treatment|"Titrated Milnacipram doses~Milnacipram: Titration to 200mg PO daily"
11047238|NCT01288833|BG000|Baseline|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
11047239|NCT01288833|BG001|Baseline|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
11047240|NCT01288833|BG002|Baseline|Total|Total of all reporting groups
11047241|NCT01288833|FG000|Participant Flow|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
11047242|NCT01288833|FG001|Participant Flow|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
11047243|NCT01288833|OG000|Outcome|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
11047244|NCT01288833|OG001|Outcome|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
11047245|NCT01288833|EG000|Reported Event|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
11348944|NCT04138498|OG000|Outcome|Treatment A|"Focalin XR 5 mg capsule~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation"
11047246|NCT01288833|EG001|Reported Event|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
11047247|NCT01288859|BG000|Baseline|All Study Participants|All participants followed all the periods
11047248|NCT01288859|FG000|Participant Flow|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
11047249|NCT01288859|FG001|Participant Flow|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
11047250|NCT01288859|FG002|Participant Flow|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
11047251|NCT01288859|FG003|Participant Flow|Control Cream|Subjects consumed 3 nut cream portions (33g each).
11047252|NCT01288859|FG004|Participant Flow|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
11047253|NCT01288859|FG005|Participant Flow|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
11047254|NCT01288859|OG000|Outcome|Free Curcumin|subjects consumed bread enriched with free curcumin
11047255|NCT01288859|OG001|Outcome|Encapsulated Curcumin|subjects consumed bread enriched with encapsulated curcumin
11047256|NCT01288859|OG002|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein
11047257|NCT01288859|OG003|Outcome|Control Cream|subjects consumed cocoa-nut cream
11047258|NCT01288859|OG004|Outcome|Free Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form
11047259|NCT01288859|OG005|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols
11047260|NCT01288859|OG000|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
11047261|NCT01288859|OG001|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
11047262|NCT01288859|OG002|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
11047263|NCT01288859|OG003|Outcome|Control|Subjects consumed white bread or nut cream
11047264|NCT01288859|OG004|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
11047265|NCT01288859|OG005|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
11047266|NCT01288859|EG000|Reported Event|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
11047267|NCT01288859|EG001|Reported Event|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
11047268|NCT01288859|EG002|Reported Event|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
11047269|NCT01288859|EG003|Reported Event|Control Cream|Subjects consumed 3 nut cream portions (33g each).
11047270|NCT01288859|EG004|Reported Event|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
11047271|NCT01288859|EG005|Reported Event|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
11047272|NCT01288911|BG000|Baseline|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
11047273|NCT01288911|BG001|Baseline|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
11047274|NCT01288911|BG002|Baseline|Total|Total of all reporting groups
11047275|NCT01288911|FG000|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
11348945|NCT04138498|OG001|Outcome|Treatment B|"CTx-1301 6.25 mg tablet~Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation"
11348946|NCT04138498|OG002|Outcome|Treatment B/A|PK Comparison of 6.25 mg CTx-1301 (treatment B) to 5 mg Focalin XR (treatment A)
11348947|NCT04138498|OG003|Outcome|Treatment C|"Focalin XR 40 mg capsule~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation"
11348948|NCT04138498|OG004|Outcome|Treatment D|"CTx-1301 50 mg tablet~Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation"
11348949|NCT04138498|OG005|Outcome|Treatment D/C|PK Comparison of 50 mg CTx-1301 (treatment D) to 40 mg Focalin XR (treatment C).
11348950|NCT04138498|OG002|Outcome|Treatment C|"Focalin XR 40 mg capsule~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation"
11047276|NCT01288911|FG001|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
11047277|NCT01288911|OG000|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
11047278|NCT01288911|OG001|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
11047279|NCT01288911|OG002|Outcome|Total Enzalutamide|Participants received enzalutamide in the double-blind and/or open-label period (including participants who switched from bicalutamide to enzalutamide).
11047280|NCT01288911|EG000|Reported Event|Double-blind Period: Enzalutamide|Participants received enzalutamide 160 mg orally once daily in the double-blind period until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
11047281|NCT01288911|EG001|Reported Event|Double-blind Period: Bicalutamide|Participants received bicalutamide 50 mg orally once daily in the double-blind period until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
11047282|NCT01288911|EG002|Reported Event|Open-label Period: Enzalutamide/Enzalutamide|Participants received enzalutamide in the double-blind period and received enzalutamide in the open-label period as well.
11047283|NCT01288911|EG003|Reported Event|Open-label Period: Bicalutamide/Enzalutamide|Participants received bicalutamide in the double-blind period and switched over to enzalutamide in the open-label period.
11047284|NCT01288937|BG000|Baseline|Milnacipran|"Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period):~Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)"
11047285|NCT01288937|BG001|Baseline|Placebo|Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).
11047286|NCT01288937|BG002|Baseline|Total|Total of all reporting groups
11047287|NCT01288937|FG000|Participant Flow|Milnacipran|"Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period):~Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)"
11047288|NCT01288937|FG001|Participant Flow|Placebo|Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).
11047289|NCT01288937|OG000|Outcome|Milnacipran|"Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period):~Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)"
11047290|NCT01288937|OG001|Outcome|Placebo|Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).
11047291|NCT01288937|EG000|Reported Event|Milnacipran|"Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period):~Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)"
11047292|NCT01288937|EG001|Reported Event|Placebo|Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).
11047293|NCT01288976|BG000|Baseline|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
11047294|NCT01288976|BG001|Baseline|Medical Management|Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
11047295|NCT01288976|BG002|Baseline|Mitral Valve Surgery|Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
11047296|NCT01288976|BG003|Baseline|Total|Total of all reporting groups
11047297|NCT01288976|FG000|Participant Flow|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
11047298|NCT01288976|FG001|Participant Flow|Medical Management|Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
11348951|NCT04138498|OG003|Outcome|Treatment D|"CTx-1301 50 mg tablet~Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation"
11348952|NCT04138498|EG000|Reported Event|Treatment A|"Focalin XR 5 mg capsule~Dexmethylphenidate 5 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation"
11348953|NCT04138498|EG001|Reported Event|Treatment B|"CTx-1301 6.25 mg tablet~Dexmethylphenidate 6.25 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation"
11348954|NCT04138498|EG002|Reported Event|Treatment C|"Focalin XR 40 mg capsule~Dexmethylphenidate 40 Mg Oral Capsule, Extended Release: Reference listed drug (RLD) for comparative BA evaluation"
11047299|NCT01288976|FG002|Participant Flow|Mitral Valve Surgery|Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
11047300|NCT01288976|OG000|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
11047301|NCT01288976|EG000|Reported Event|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
11047302|NCT01288976|EG001|Reported Event|Medical Management|"Patients with MR managed nonsurgically based on standard hospital clinical practice.~Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included."
11047303|NCT01288976|EG002|Reported Event|Mitral Valve Surgery|Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
11047304|NCT01288989|BG000|Baseline|5 mg/kg IMC-3C5|"Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047305|NCT01288989|BG001|Baseline|10 mg/kg IMC-3C5|"Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047306|NCT01288989|BG002|Baseline|20 mg/kg IMC-3C5|"Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047307|NCT01288989|BG003|Baseline|30 mg/kg IMC-3C5|"Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047308|NCT01288989|BG004|Baseline|30 mg/kg IMC-3C5 (CRC)|"Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047309|NCT01288989|BG005|Baseline|Total|Total of all reporting groups
11047310|NCT01288989|FG000|Participant Flow|5 mg/kg IMC-3C5|"Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047311|NCT01288989|FG001|Participant Flow|10 mg/kg IMC-3C5|"Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047312|NCT01288989|FG002|Participant Flow|20 mg/kg IMC-3C5|"Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047313|NCT01288989|FG003|Participant Flow|30 mg/kg IMC-3C5|"Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047314|NCT01288989|FG004|Participant Flow|30 mg/kg IMC-3C5 (CRC)|"Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047315|NCT01288989|OG000|Outcome|5 mg/kg IMC-3C5|"Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11348955|NCT04138498|EG003|Reported Event|Treatment D|"CTx-1301 50 mg tablet~Dexmethylphenidate 50 Mg Oral Tablet, Extended Release: Investigational Medication for comparative BA evaluation"
11047316|NCT01288989|OG001|Outcome|10 mg/kg IMC-3C5|"Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047317|NCT01288989|OG002|Outcome|20 mg/kg IMC-3C5|"Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047318|NCT01288989|OG003|Outcome|30 mg/kg IMC-3C5|"Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047319|NCT01288989|OG004|Outcome|30 mg/kg IMC-3C5 (CRC)|"Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met."
11047320|NCT01288989|OG000|Outcome|5 mg/kg IMC-3C5|"Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047321|NCT01288989|OG001|Outcome|10 mg/kg IMC-3C5|"Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047322|NCT01288989|OG002|Outcome|20 mg/kg IMC-3C5|"Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047323|NCT01288989|OG003|Outcome|30 mg/kg IMC-3C5|"Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047324|NCT01288989|OG000|Outcome|30 mg/kg IMC-3C5|"Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047325|NCT01288989|OG004|Outcome|30 mg/kg IMC-3C5 (CRC)|"Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047326|NCT01288989|EG000|Reported Event|5 mg/kg IMC-3C5|"Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047327|NCT01288989|EG001|Reported Event|10 mg/kg IMC-3C5|"Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047328|NCT01288989|EG002|Reported Event|20 mg/kg IMC-3C5|"Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047329|NCT01288989|EG003|Reported Event|30 mg/kg IMC-3C5|"Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047330|NCT01288989|EG004|Reported Event|30 mg/kg IMC-3C5 (CRC)|"Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).~After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met."
11047331|NCT01289015|BG000|Baseline|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
11047332|NCT01289015|BG001|Baseline|Placebo|Placebo : Topical; applied once daily for two weeks
11047333|NCT01289015|BG002|Baseline|Total|Total of all reporting groups
11348956|NCT04138043|BG000|Baseline|Placebo|Participants received a single SC dose of Placebo, administered as three separate SC injections.
11047334|NCT01289015|FG000|Participant Flow|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
11047335|NCT01289015|FG001|Participant Flow|Placebo|Placebo : Topical; applied once daily for two weeks
11047336|NCT01289015|OG000|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
11047337|NCT01289015|OG001|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
11047338|NCT01289015|EG000|Reported Event|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
11047339|NCT01289015|EG001|Reported Event|Placebo|Placebo : Topical; applied once daily for two weeks
11047340|NCT01289028|BG000|Baseline|Nilotinib|
11047341|NCT01289028|FG000|Participant Flow|Nilotinib|
11047342|NCT01289028|OG000|Outcome|Nilotinib|
11047343|NCT01289028|OG000|Outcome|Nilotinib|ITT
11047344|NCT01289028|OG000|Outcome|Nilotinib|Per Protocol population
11047345|NCT01289028|EG000|Reported Event|All Patients|All patients
11047346|NCT01289041|BG000|Baseline|All Patients|
11047347|NCT01289041|FG000|Participant Flow|All Patients|
11047348|NCT01289041|OG000|Outcome|Activated Pl3K|
11047349|NCT01289041|OG001|Outcome|Non-Activated Pl3K|
11047350|NCT01289041|OG002|Outcome|All Patients|
11047351|NCT01289041|EG000|Reported Event|All Patients|
11047352|NCT01289067|BG000|Baseline|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
11047353|NCT01289067|FG000|Participant Flow|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
11047354|NCT01289067|OG000|Outcome|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
11047355|NCT01289067|EG000|Reported Event|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
11047356|NCT01289080|BG000|Baseline|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
11047357|NCT01289080|BG001|Baseline|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
11047358|NCT01289080|BG002|Baseline|Total|Total of all reporting groups
11047359|NCT01289080|FG000|Participant Flow|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
11047360|NCT01289080|FG001|Participant Flow|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
11047361|NCT01289080|OG000|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
11047362|NCT01289080|OG001|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
11047363|NCT01289080|OG001|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
11047364|NCT01289080|OG001|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
11047365|NCT01289080|EG000|Reported Event|Brexpiprazole 3mg|Participants with normal renal function and severe renal impairment were administered 3 mg brexpiprazole.
11047366|NCT01289119|BG000|Baseline|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
11047367|NCT01289119|BG001|Baseline|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
11047368|NCT01289119|BG002|Baseline|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
11047369|NCT01289119|BG003|Baseline|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
11047370|NCT01289119|BG004|Baseline|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
11047371|NCT01289119|BG005|Baseline|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
11047372|NCT01289119|BG006|Baseline|Total|Total of all reporting groups
11047373|NCT01289119|FG000|Participant Flow|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
11047374|NCT01289119|FG001|Participant Flow|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
11047375|NCT01289119|FG002|Participant Flow|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
11047376|NCT01289119|FG003|Participant Flow|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
11047377|NCT01289119|FG004|Participant Flow|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
11047378|NCT01289119|FG005|Participant Flow|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
11047379|NCT01289119|OG000|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
11047380|NCT01289119|OG001|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
11047381|NCT01289119|OG002|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
11047382|NCT01289119|OG003|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
11047383|NCT01289119|OG004|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
11047384|NCT01289119|OG005|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
11047385|NCT01289119|EG000|Reported Event|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
11047386|NCT01289119|EG001|Reported Event|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
11047387|NCT01289119|EG002|Reported Event|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
11047388|NCT01289119|EG003|Reported Event|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
11047389|NCT01289119|EG004|Reported Event|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
11047390|NCT01289119|EG005|Reported Event|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
11047391|NCT01289210|BG000|Baseline|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
11047392|NCT01289210|FG000|Participant Flow|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then administered weekly for 3 weeks in a 4 week cycle over 3 cycles.
11047393|NCT01289210|OG000|Outcome|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then admnistered weekly for 3 weeks in a 4 week cycle over 3 cycles.
11047394|NCT01289210|EG000|Reported Event|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
11047395|NCT01289275|BG000|Baseline|Telephone Counseling|Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
11047396|NCT01289275|BG001|Baseline|Nicotine Patches|"Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices."
11047397|NCT01289275|BG002|Baseline|Telephone Counseling and Nicotine Patches|"Nicotine Patches: 8 weeks of nicotine patches at discharge.~Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse."
11047398|NCT01289275|BG003|Baseline|Brief Hospital Counseling|Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
11047399|NCT01289275|BG004|Baseline|Total|Total of all reporting groups
11047400|NCT01289275|FG000|Participant Flow|Telephone Counseling|Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
11047401|NCT01289275|FG001|Participant Flow|Nicotine Patches|"Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices."
11047402|NCT01289275|FG002|Participant Flow|Telephone Counseling and Nicotine Patches|"Nicotine Patches: 8 weeks of nicotine patches at discharge.~Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse."
11047403|NCT01289275|FG003|Participant Flow|Brief Hospital Counseling|Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
11047404|NCT01289275|OG000|Outcome|Telephone Counseling|Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
11047405|NCT01289275|OG001|Outcome|Nicotine Patches|"Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices."
11047406|NCT01289275|OG002|Outcome|Telephone Counseling and Nicotine Patches|"Nicotine Patches: 8 weeks of nicotine patches at discharge.~Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse."
11047407|NCT01289275|OG003|Outcome|Brief Hospital Counseling|Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
11348957|NCT04138043|BG001|Baseline|GSK2330811 450 mg|Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]).
11348958|NCT04138043|BG002|Baseline|Total|Total of all reporting groups
11348959|NCT04138043|FG000|Participant Flow|Placebo|Participants received a single SC dose of Placebo, administered as three separate SC injections.
11047408|NCT01289275|OG000|Outcome|Telephone Counseling|"Up to 5 proactive counseling sessions~Telephone Counseling: Up to 5 proactive counseling sessions from California Smokers' Helpline.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices."
11047409|NCT01289275|OG001|Outcome|Nicotine Patches|"8 weeks of nicotine patches~Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices."
11047410|NCT01289275|OG002|Outcome|Telephone Counseling + Patches|"5 proactive sessions, 8 weeks patches~Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Telephone Counseling: Up to 5 proactive counseling sessions from California Smokers' Helpline.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices."
11047411|NCT01289275|OG003|Outcome|Brief Hospital Counseling|"brief in hospital counseling, no proactive sessions or patches~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices."
11047412|NCT01289275|EG000|Reported Event|Telephone Counseling|Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
11047413|NCT01289275|EG001|Reported Event|Nicotine Patches|"Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices."
11047414|NCT01289275|EG002|Reported Event|Telephone Counseling and Nicotine Patches|"Nicotine Patches: 8 weeks of nicotine patches at discharge.~Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse."
11047415|NCT01289275|EG003|Reported Event|Brief Hospital Counseling|Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
11047416|NCT01289353|BG000|Baseline|ChemoRT|"Concurrent Carboplatin and Radiotherapy~Carboplatin: IV, weekly for 6 weeks, AUC of 2.0~3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy"
11047417|NCT01289353|FG000|Participant Flow|ChemoRT|"Concurrent Carboplatin and Radiotherapy~Carboplatin: IV, weekly for 6 weeks, AUC of 2.0~3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy"
11047418|NCT01289353|OG000|Outcome|ChemoRT|"Concurrent Carboplatin and Radiotherapy~Carboplatin: IV, weekly for 6 weeks, AUC of 2.0~3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy"
11047419|NCT01289353|EG000|Reported Event|ChemoRT|"Concurrent Carboplatin and Radiotherapy~Carboplatin: IV, weekly for 6 weeks, AUC of 2.0~3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy"
11047420|NCT01289392|BG000|Baseline|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
11047421|NCT01289392|BG001|Baseline|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
11348960|NCT04138043|FG001|Participant Flow|GSK2330811 450 mg|Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]).
11348961|NCT04138043|OG000|Outcome|Placebo|Participants received a single SC dose of Placebo, administered as three separate SC injections.
11348962|NCT04138043|OG001|Outcome|GSK2330811 450 mg|Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]).
11047422|NCT01289392|BG002|Baseline|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
11047423|NCT01289392|BG003|Baseline|Total|Total of all reporting groups
11047424|NCT01289392|FG000|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
11047425|NCT01289392|FG001|Participant Flow|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
11047426|NCT01289392|FG002|Participant Flow|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
11047427|NCT01289392|OG000|Outcome|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
11047428|NCT01289392|OG001|Outcome|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
11047429|NCT01289392|OG002|Outcome|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
11047430|NCT01289392|EG000|Reported Event|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
11047431|NCT01289392|EG001|Reported Event|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
11047432|NCT01289392|EG002|Reported Event|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
11047433|NCT01289418|BG000|Baseline|Health Care Workers in Quebec|Health care workers from Quebec
11047434|NCT01289418|BG001|Baseline|Health Care Workers in Toronto|Health Care Workers from Toronto
11047435|NCT01289418|BG002|Baseline|Health Care Workers in Halifax|Health Care Workers from Halifax
11047436|NCT01289418|BG003|Baseline|Total|Total of all reporting groups
11047437|NCT01289418|FG000|Participant Flow|Health Care Workers|Health care workers from all hospitals
11047438|NCT01289418|OG000|Outcome|Health Care Workers|Health care workers with a valid e-mail address
11047439|NCT01289418|OG000|Outcome|Health Care Workers|Health care workers with a valid email address
11047440|NCT01289418|OG000|Outcome|Health Care Workers From CHUQ Hospitals|
11047441|NCT01289418|EG000|Reported Event|Health Care Workers From CHUQ Hospitals|
11047442|NCT01289431|BG000|Baseline|0.3% Once a Day|BOL-303242-X dosed in the eye
11047443|NCT01289431|BG001|Baseline|2% Once a Day|BOL-303242-X dosed in the eye
11047444|NCT01289431|BG002|Baseline|3% Once a Day|BOL-303242-X dosed in the eye
11047445|NCT01289431|BG003|Baseline|0.3% Twice a Day|BOL-303242-X dosed in the eye
11047446|NCT01289431|BG004|Baseline|2% Twice a Day|BOL-303242-X dosed in the eye
11047447|NCT01289431|BG005|Baseline|3% Twice a Day|BOL-303242-X dosed in the eye
11047448|NCT01289431|BG006|Baseline|Vehicle|Vehicle of BOL-303242-X dosed in the eye
11047449|NCT01289431|BG007|Baseline|Total|Total of all reporting groups
11047450|NCT01289431|FG000|Participant Flow|0.3% Once a Day|BOL-303242-X dosed in the eye
11047451|NCT01289431|FG001|Participant Flow|2% Once a Day|BOL-303242-X dosed in the eye
11047452|NCT01289431|FG002|Participant Flow|3% Once a Day|BOL-303242-X dosed in the eye
11047453|NCT01289431|FG003|Participant Flow|0.3% Twice a Day|BOL-303242-X dosed in the eye
11047454|NCT01289431|FG004|Participant Flow|2% Twice a Day|BOL-303242-X dosed in the eye
11047455|NCT01289431|FG005|Participant Flow|3% Twice a Day|BOL-303242-X dosed in the eye
11047456|NCT01289431|FG006|Participant Flow|Vehicle|Vehicle of BOL-303242-X dosed in the eye
11047457|NCT01289431|OG000|Outcome|0.3% Once a Day|BOL-303242-X dosed in the eye
11047458|NCT01289431|OG001|Outcome|2% Once a Day|BOL-303242-X dosed in the eye
11047459|NCT01289431|OG002|Outcome|3% Once a Day|BOL-303242-X dosed in the eye
11047460|NCT01289431|OG003|Outcome|0.3% Twice a Day|BOL-303242-X dosed in the eye
11047461|NCT01289431|OG004|Outcome|2% Twice a Day|BOL-303242-X dosed in the eye
11047462|NCT01289431|OG005|Outcome|3% Twice a Day|BOL-303242-X dosed in the eye
11047463|NCT01289431|OG006|Outcome|Vehicle|Vehicle of BOL-303242-X dosed in the eye
11047464|NCT01289431|EG000|Reported Event|0.3% Once a Day|BOL-303242-X dosed in the eye
11047465|NCT01289431|EG001|Reported Event|2% Once a Day|BOL-303242-X dosed in the eye
11047466|NCT01289431|EG002|Reported Event|3% Once a Day|BOL-303242-X dosed in the eye
11047467|NCT01289431|EG003|Reported Event|0.3% Twice a Day|BOL-303242-X dosed in the eye
11047468|NCT01289431|EG004|Reported Event|2% Twice a Day|BOL-303242-X dosed in the eye
11047469|NCT01289431|EG005|Reported Event|3% Twice a Day|BOL-303242-X dosed in the eye
11047470|NCT01289431|EG006|Reported Event|Vehicle|Vehicle of BOL-303242-X dosed in the eye
11047471|NCT01289457|BG000|Baseline|Clofarabine + Idarubicin + Cytarabine|"Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.~Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle."
11047472|NCT01289457|BG001|Baseline|Group 1 CIA|"Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.~Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle."
11047473|NCT01289457|BG002|Baseline|Group 2 FLAI|"Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.~Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5)."
11047474|NCT01289457|BG003|Baseline|Total|Total of all reporting groups
11348963|NCT04138043|OG000|Outcome|GSK2330811 450 mg|Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]).
11047475|NCT01289457|FG000|Participant Flow|Clofarabine + Idarubicin + Cytarabine|"Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.~Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle."
11047476|NCT01289457|FG001|Participant Flow|Group 1 CIA|"Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.~Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle."
11047477|NCT01289457|FG002|Participant Flow|Group 2 FLAI|"Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.~Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5)."
11047478|NCT01289457|OG000|Outcome|Clofarabine + Idarubicin + Cytarabine|"Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.~Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle."
11047479|NCT01289457|OG001|Outcome|Group 1 CIA|"Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.~Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle."
11047480|NCT01289457|OG002|Outcome|Group 2 FLAI|"Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.~Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5)."
11047481|NCT01289457|EG000|Reported Event|Clofarabine + Idarubicin + Cytarabine|"Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.~Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle."
11047482|NCT01289457|EG001|Reported Event|Group 1 CIA|"Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.~Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle."
11047483|NCT01289457|EG002|Reported Event|Group 2 FLAI|"Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.~Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.~Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.~Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5)."
11047484|NCT01289522|BG000|Baseline|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m2 IV every 2 weeks during the maintenance therapy.~Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
11047485|NCT01289522|FG000|Participant Flow|Cetuximab|"cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² over 60 minutes weekly on subsequent administrations~500mg/m2 every 2 weeks during the maintenance therapy. Drug: -Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles~Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support mandatory after each cycle of chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the 4th cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks."
11348964|NCT04138043|EG000|Reported Event|Placebo|Participants received a single SC dose of Placebo, administered as three separate SC injections.
11047486|NCT01289522|OG000|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according~cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
11047487|NCT01289522|EG000|Reported Event|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m2 IV every 2 weeks during the maintenance therapy.~Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
11047488|NCT01289548|BG000|Baseline|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
11047489|NCT01289548|BG001|Baseline|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
11047490|NCT01289548|BG002|Baseline|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
11047491|NCT01289548|BG003|Baseline|Total|Total of all reporting groups
11047492|NCT01289548|FG000|Participant Flow|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
11047493|NCT01289548|FG001|Participant Flow|Donor RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
11047494|NCT01289548|FG002|Participant Flow|Recipient PIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
11047495|NCT01289548|OG000|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
11047496|NCT01289548|OG001|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
11047497|NCT01289548|OG002|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
11047498|NCT01289548|EG000|Reported Event|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
11047499|NCT01289548|EG001|Reported Event|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
11047500|NCT01289548|EG002|Reported Event|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
11047501|NCT01289574|BG000|Baseline|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
11047502|NCT01289574|BG001|Baseline|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
11047503|NCT01289574|BG002|Baseline|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
11047504|NCT01289574|BG003|Baseline|Total|Total of all reporting groups
11047505|NCT01289574|FG000|Participant Flow|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
11047506|NCT01289574|FG001|Participant Flow|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
11047507|NCT01289574|FG002|Participant Flow|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
11047508|NCT01289574|OG000|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
11047509|NCT01289574|OG001|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
11047510|NCT01289574|OG002|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
11047511|NCT01289574|OG000|Outcome|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
11047512|NCT01289574|EG000|Reported Event|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
11047513|NCT01289574|EG001|Reported Event|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
11047514|NCT01289574|EG002|Reported Event|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
11047515|NCT01289639|BG000|Baseline|Arm 1|"matching placebo for fenofibrate 1 po qd~matching placebo for pioglitazone 1 po qd"
11047516|NCT01289639|BG001|Baseline|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
11047517|NCT01289639|BG002|Baseline|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
11047518|NCT01289639|BG003|Baseline|Total|Total of all reporting groups
11047519|NCT01289639|FG000|Participant Flow|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
11047520|NCT01289639|FG001|Participant Flow|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
11047521|NCT01289639|FG002|Participant Flow|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
11047522|NCT01289639|OG000|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
11047523|NCT01289639|OG001|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
11047524|NCT01289639|OG002|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
11047525|NCT01289639|EG000|Reported Event|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
11047526|NCT01289639|EG001|Reported Event|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
11047527|NCT01289639|EG002|Reported Event|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
11047528|NCT01289665|BG000|Baseline|Lubricating Gel|Lubricating gel used during speculum insertion.: Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.
11047529|NCT01289665|BG001|Baseline|Water|Water used during speculum examination.: Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
11047530|NCT01289665|BG002|Baseline|Total|Total of all reporting groups
11047531|NCT01289665|FG000|Participant Flow|Lubricating Gel|Lubricating gel used during speculum insertion.: Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.
11047532|NCT01289665|FG001|Participant Flow|Water|Water used during speculum examination.: Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
11047533|NCT01289665|OG000|Outcome|Lubricating Gel|Lubricating gel used during speculum insertion.: Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.
11047534|NCT01289665|OG001|Outcome|Water|Water used during speculum examination.: Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
11047535|NCT01289665|EG000|Reported Event|Lubricating Gel|Lubricating gel used during speculum insertion.: Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.
11047536|NCT01289665|EG001|Reported Event|Water|Water used during speculum examination.: Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
11047537|NCT01289678|BG000|Baseline|Interleukin-2|"interleukin-2 therapy during lymphocyte recovery~Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days"
11047538|NCT01289678|FG000|Participant Flow|Interleukin-2|"interleukin-2 therapy during lymphocyte recovery~Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days"
11047539|NCT01289678|OG000|Outcome|Interleukin-2|"interleukin-2 therapy during lymphocyte recovery~Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days"
11047540|NCT01289678|EG000|Reported Event|Interleukin-2|"interleukin-2 therapy during lymphocyte recovery~Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days"
11047541|NCT01289782|BG000|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047542|NCT01289782|BG001|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
11047543|NCT01289782|BG002|Baseline|Total|Total of all reporting groups
11047544|NCT01289782|FG000|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047545|NCT01289782|FG001|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
11047546|NCT01289782|OG000|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047547|NCT01289782|OG001|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
11047548|NCT01289782|EG000|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047549|NCT01289782|EG001|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
11047550|NCT01289821|BG000|Baseline|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L-folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
11047551|NCT01289821|FG000|Participant Flow|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L-folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
11047552|NCT01289821|OG000|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L-folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
11047553|NCT01289821|EG000|Reported Event|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
11047554|NCT01289847|BG000|Baseline|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
11047555|NCT01289847|FG000|Participant Flow|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
11047556|NCT01289847|OG000|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
11047557|NCT01289847|EG000|Reported Event|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
11047558|NCT01289912|BG000|Baseline|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
11047559|NCT01289912|BG001|Baseline|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
11047560|NCT01289912|BG002|Baseline|Total|Total of all reporting groups
11047561|NCT01289912|FG000|Participant Flow|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
11047562|NCT01289912|FG001|Participant Flow|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
11047563|NCT01289912|OG000|Outcome|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
11348965|NCT04138043|EG001|Reported Event|GSK2330811 450 mg|Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]).
11348966|NCT04137627|BG000|Baseline|Melatonin Group|Participants who received Melatonin (treatment arm) who finished study protocol
11348967|NCT04137627|BG001|Baseline|Placebo Group|Participants who received Placebo (control arm) who finished study protocol
11348968|NCT04137627|BG002|Baseline|Total|Total of all reporting groups
11047564|NCT01289912|OG001|Outcome|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
11047565|NCT01289912|OG000|Outcome|Placebo - Baseline|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
11047566|NCT01289912|OG001|Outcome|RAD001 - Baseline|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
11047567|NCT01289912|OG002|Outcome|Placebo - 6 Months|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
11047568|NCT01289912|OG003|Outcome|RAD001 - 6 Months|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
11047569|NCT01289912|OG000|Outcome|Placebo - Baseline|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Baseline.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
11047570|NCT01289912|OG001|Outcome|RAD001 - Baseline|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. Baseline.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
11047571|NCT01289912|OG002|Outcome|Placebo - 6 Months|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. 6 months.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
11047572|NCT01289912|OG003|Outcome|RAD001 - 6 Months|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. 6 months.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
11047573|NCT01289912|OG000|Outcome|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
11047574|NCT01289912|OG001|Outcome|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
11047575|NCT01289912|EG000|Reported Event|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
11149160|NCT01869075|FG002|Participant Flow|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11149161|NCT01869075|FG003|Participant Flow|MGS - Usual Care|Usual care provided at the hospital
11047576|NCT01289912|EG001|Reported Event|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
11047577|NCT01289990|BG000|Baseline|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
11047578|NCT01289990|BG001|Baseline|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047579|NCT01289990|BG002|Baseline|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
11047580|NCT01289990|BG003|Baseline|Sitagliptin 100 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100 mg: Sitagliptin once daily"
11047581|NCT01289990|BG004|Baseline|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
11047582|NCT01289990|BG005|Baseline|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047583|NCT01289990|BG006|Baseline|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047584|NCT01289990|BG007|Baseline|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
11047585|NCT01289990|BG008|Baseline|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047586|NCT01289990|BG009|Baseline|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047587|NCT01289990|BG010|Baseline|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
11047588|NCT01289990|BG011|Baseline|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047589|NCT01289990|BG012|Baseline|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047590|NCT01289990|BG013|Baseline|Total|Total of all reporting groups
11047591|NCT01289990|FG000|Participant Flow|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
11047592|NCT01289990|FG001|Participant Flow|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 10 mg"
11047593|NCT01289990|FG002|Participant Flow|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
11047594|NCT01289990|FG003|Participant Flow|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100mg: Sitagliptin once daily"
11047595|NCT01289990|FG004|Participant Flow|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
11047596|NCT01289990|FG005|Participant Flow|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047597|NCT01289990|FG006|Participant Flow|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047598|NCT01289990|FG007|Participant Flow|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
11047599|NCT01289990|FG008|Participant Flow|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11226426|NCT02374463|FG001|Participant Flow|Tai Chi|Tai Chi Intervention: The supervised Tai Chi class will be held 3-times a week for one hour. All Tai Chi classes will be taught in a group setting by an experienced instructor. The emphasis during the class will be on standing movements, body alignment, weight shift and changes of direction. Movements will be adapted as the class progresses to increase the difficulty of weight shift and change in direction over time so that participants balance is continually challenged throughout the 6 months. Chairs or hand rails will be available for the participants to use as needed for balance recovery.
11226427|NCT02374463|OG000|Outcome|MMBI|Multimodality Balance Intervention (MMBI)
11047600|NCT01289990|FG009|Participant Flow|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047601|NCT01289990|FG010|Participant Flow|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
11047602|NCT01289990|FG011|Participant Flow|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047603|NCT01289990|FG012|Participant Flow|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047604|NCT01289990|OG000|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
11047605|NCT01289990|OG001|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
11047606|NCT01289990|OG002|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
11047607|NCT01289990|OG003|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
11047608|NCT01289990|OG004|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
11047609|NCT01289990|OG005|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
11047610|NCT01289990|OG006|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
11047611|NCT01289990|OG007|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
11047612|NCT01289990|OG008|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
11047613|NCT01289990|OG009|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
11047614|NCT01289990|OG010|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
11047615|NCT01289990|OG011|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
11047616|NCT01289990|OG012|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
11047617|NCT01289990|EG000|Reported Event|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
11047618|NCT01289990|EG001|Reported Event|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 10 mg"
11047619|NCT01289990|EG002|Reported Event|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
11047620|NCT01289990|EG003|Reported Event|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100mg: Sitagliptin once daily"
11047621|NCT01289990|EG004|Reported Event|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
11047622|NCT01289990|EG005|Reported Event|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047623|NCT01289990|EG006|Reported Event|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047624|NCT01289990|EG007|Reported Event|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
11047625|NCT01289990|EG008|Reported Event|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047626|NCT01289990|EG009|Reported Event|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047627|NCT01289990|EG010|Reported Event|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
11226428|NCT02374463|OG001|Outcome|Tai Chi|Tai Chi Intervention
11226429|NCT02374463|OG000|Outcome|MMBI|Multimodality Balance Intervention (MMBI):
11047628|NCT01289990|EG011|Reported Event|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
11047629|NCT01289990|EG012|Reported Event|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
11047630|NCT01290029|BG000|Baseline|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
11047631|NCT01290029|FG000|Participant Flow|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
11047632|NCT01290029|OG000|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
11047633|NCT01290029|EG000|Reported Event|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
11047634|NCT01290068|BG000|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
11047635|NCT01290068|BG001|Baseline|Monofocal IOL|Monofocal IOL, bilateral implantation
11047636|NCT01290068|BG002|Baseline|Total|Total of all reporting groups
11047637|NCT01290068|FG000|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
11047638|NCT01290068|FG001|Participant Flow|Monofocal IOL|Monofocal IOL, bilateral implantation
11047639|NCT01290068|OG000|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
11047640|NCT01290068|OG001|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
11047641|NCT01290068|EG000|Reported Event|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
11047642|NCT01290068|EG001|Reported Event|Monofocal IOL|Monofocal IOL, bilateral implantation
11047643|NCT01290094|BG000|Baseline|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
11047644|NCT01290094|FG000|Participant Flow|Ibandronate|Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
11047645|NCT01290094|OG000|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
11047646|NCT01290094|EG000|Reported Event|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections).
11047647|NCT01290224|BG000|Baseline|Sham Procedure + Scrambler Treatment|
11047648|NCT01290224|FG000|Participant Flow|Sham Procedure + Scrambler Treatment|
11047649|NCT01290224|OG000|Outcome|Sham Procedure + Scrambler Treatment|
11047650|NCT01290224|OG000|Outcome|Sham Procedure (Day 1 )|
11047651|NCT01290224|OG001|Outcome|Scrambler Therapy (Day 2)|
11047652|NCT01290224|EG000|Reported Event|Sham Procedure + Scrambler Treatment|
11047653|NCT01290237|BG000|Baseline|Vancomycin Loading Dose|"Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
11047654|NCT01290237|BG001|Baseline|Control|"Intravenous vancomycin 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
11047655|NCT01290237|BG002|Baseline|Total|Total of all reporting groups
11047656|NCT01290237|FG000|Participant Flow|Vancomycin Loading Dose|"Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
11047657|NCT01290237|FG001|Participant Flow|Control|"Intravenous vancomycin 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
11047658|NCT01290237|OG000|Outcome|Vancomycin Loading Dose|"Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
11047659|NCT01290237|OG001|Outcome|Control|"Intravenous vancomycin 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
11047660|NCT01290237|OG000|Outcome|Loading Dose|As above
11047661|NCT01290237|OG001|Outcome|Conventional Dose|as above
11047662|NCT01290237|EG000|Reported Event|Vancomycin Loading Dose|"Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
11047663|NCT01290237|EG001|Reported Event|Control|"Intravenous vancomycin 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
11047664|NCT01290263|BG000|Baseline|Cohort B: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
11047665|NCT01290263|BG001|Baseline|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
11047666|NCT01290263|BG002|Baseline|Total|Total of all reporting groups
11047667|NCT01290263|FG000|Participant Flow|Cohort A: AMG 386 30 mg/kg|Cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
11047668|NCT01290263|FG001|Participant Flow|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
11149162|NCT01869075|FG004|Participant Flow|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11047669|NCT01290263|FG002|Participant Flow|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.~As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg + kg."
11047670|NCT01290263|FG003|Participant Flow|Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab|Participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the maximum tolerated AMG 386 dose established in the Phase I Cohort B study, AMG 386 of 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
11047671|NCT01290263|FG004|Participant Flow|All Cohort B Participants: AMG 386 + Bevacizumab|Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
11047672|NCT01290263|OG000|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
11047673|NCT01290263|OG001|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
11047674|NCT01290263|OG000|Outcome|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
11047675|NCT01290263|OG001|Outcome|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.~As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg."
11047676|NCT01290263|EG000|Reported Event|Cohort B: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
11047677|NCT01290263|EG001|Reported Event|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
11047678|NCT01290315|BG000|Baseline|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
11047679|NCT01290315|BG001|Baseline|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
11047680|NCT01290315|BG002|Baseline|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)"
11047681|NCT01290315|BG003|Baseline|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
11047682|NCT01290315|BG004|Baseline|Total|Total of all reporting groups
11047683|NCT01290315|FG000|Participant Flow|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
11047684|NCT01290315|FG001|Participant Flow|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
11047685|NCT01290315|FG002|Participant Flow|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)"
11047686|NCT01290315|FG003|Participant Flow|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
11047687|NCT01290315|OG000|Outcome|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
11047688|NCT01290315|OG001|Outcome|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
11047689|NCT01290315|OG002|Outcome|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)"
11047690|NCT01290315|OG003|Outcome|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
11047691|NCT01290315|OG002|Outcome|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750mg dose at 100 mg/minute (Cohort II)"
11047692|NCT01290315|EG000|Reported Event|Ferric Carboxymaltose (FCM)|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)"
11047693|NCT01290315|EG001|Reported Event|Iron Sucrose or Iron Dextran|"Intravenous iron~Iron Sucrose / Iron Dextran: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
11149163|NCT01869075|FG005|Participant Flow|HFS - Usual Care|Usual care provided at the hospital
11149164|NCT01869075|OG000|Outcome|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11047694|NCT01290341|BG000|Baseline|NAFT-600|Topical; applied once daily for two weeks
11047695|NCT01290341|BG001|Baseline|Placebo|Topical; applied once daily for two weeks.
11047696|NCT01290341|BG002|Baseline|Total|Total of all reporting groups
11047697|NCT01290341|FG000|Participant Flow|NAFT-600|Topical; applied once daily for two weeks
11047698|NCT01290341|FG001|Participant Flow|Placebo|Topical; applied once daily for two weeks.
11047699|NCT01290341|OG000|Outcome|NAFT-600|Topical; applied once daily for two weeks
11047700|NCT01290341|OG001|Outcome|Placebo|Topical; applied once daily for two weeks.
11047701|NCT01290341|EG000|Reported Event|NAFT-600|Topical; applied once daily for two weeks
11047702|NCT01290341|EG001|Reported Event|Placebo|Topical; applied once daily for two weeks.
11047703|NCT01290445|BG000|Baseline|Varenicline Exposed Cohort|Participants included infants who were exposed to varenicline in utero.
11047704|NCT01290445|BG001|Baseline|Varenicline Unexposed Cohort|Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
11047705|NCT01290445|BG002|Baseline|Reference Cohort|Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
11348969|NCT04137627|FG000|Participant Flow|Melatonin|"The group received standard treatment with the oral administration of Melatonin~Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect."
11047706|NCT01290445|BG003|Baseline|Total|Total of all reporting groups
11047707|NCT01290445|FG000|Participant Flow|Varenicline Exposed Cohort|Participants included infants who were exposed to varenicline in utero.
11047708|NCT01290445|FG001|Participant Flow|Varenicline Unexposed Cohort|Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
11047709|NCT01290445|FG002|Participant Flow|Reference Cohort|Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
11047710|NCT01290445|OG000|Outcome|Varenicline Exposed Cohort|Participants included infants who were exposed to varenicline in utero.
11047711|NCT01290445|OG001|Outcome|Varenicline Unexposed Cohort|Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
11047712|NCT01290445|OG002|Outcome|Reference Cohort|Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
11047713|NCT01290445|EG000|Reported Event|Varenicline Exposed Cohort|Participants included infants who were exposed to varenicline in utero.
11047714|NCT01290445|EG001|Reported Event|Varenicline Unexposed Cohort|Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
11047715|NCT01290445|EG002|Reported Event|Reference Cohort|Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
11047716|NCT01290484|BG000|Baseline|Sildenafil|Male and female subjects between the ages of 6 months and 10 years, weighing at least 8 kg and had been given a diagnosis of a lymphatic malformation of at least 3 cm based on clinical and radiologic criteria. Macrocystic, microcystic, or mixed lymphatic malformations involving any location on the body were included. Lymphatic malformations associated with an incomplete response to previous treatments, a risk of functional or aesthetic impairment, or local complications were included.
11047717|NCT01290484|FG000|Participant Flow|Sildenafil|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).
11047718|NCT01290484|OG000|Outcome|Sildenafil|The primary outcome was the effect of sildenafil on lymphatic malformation volume. Response to sildenafil was characterized by any decrease in lymphatic malformation volume. Lymphatic malformations volumes were assessed blindly by MRI volume segmentation analysis at baseline and after 20 weeks of sildenafil. 4 subjects had a lymphatic malformation volume decrease.
11047719|NCT01290484|EG000|Reported Event|Sildenafil|Adverse events reported while one sildenafil were minimal. All subjects tolerated the prescribed medication dose. One subject developed an upper respiratory tract infection and experienced temporary hearing loss due to fluid accumulation. This was resolved completely and she experienced no further hearing loss while on sildenafil. Four parents requested to have the child continue sildenafil after study completion.
11047720|NCT01290523|BG000|Baseline|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
11047721|NCT01290523|FG000|Participant Flow|Yttrium-90 Liver Radioembolization 1 Treatment|"Patients who received 1 liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
11047722|NCT01290523|OG000|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
11047723|NCT01290523|EG000|Reported Event|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
11047724|NCT01290536|BG000|Baseline|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
11149165|NCT01869075|OG001|Outcome|AMI - Usual Care|Usual care as provided at the hospital
11348970|NCT04137627|FG001|Participant Flow|Placebo|"The group received standard treatment with the oral administration of Placebo~Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy"
11348971|NCT04137627|OG000|Outcome|Melatonin|"The group received standard treatment with the oral administration of Melatonin~Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect."
11047725|NCT01290536|FG000|Participant Flow|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
11047726|NCT01290536|OG000|Outcome|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
11047727|NCT01290536|OG000|Outcome|Colorectal - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
11047728|NCT01290536|OG001|Outcome|Neuroendocrine - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
11047729|NCT01290536|OG002|Outcome|Other Tumors - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
11047730|NCT01290536|EG000|Reported Event|Yttrium-90 Liver Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
11047731|NCT01290601|BG000|Baseline|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
11047732|NCT01290601|BG001|Baseline|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
11047733|NCT01290601|BG002|Baseline|Total|Total of all reporting groups
11047734|NCT01290601|FG000|Participant Flow|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
11047735|NCT01290601|FG001|Participant Flow|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
11047736|NCT01290601|FG002|Participant Flow|Cohort 2 Tafenoquine|"Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.~tafenoquine: Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days."
11047737|NCT01290601|FG003|Participant Flow|Cohort 2 Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days."
11047738|NCT01290601|OG000|Outcome|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
11047739|NCT01290601|OG001|Outcome|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
11047740|NCT01290601|EG000|Reported Event|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
11047741|NCT01290601|EG001|Reported Event|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
11047742|NCT01290614|BG000|Baseline|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
11226430|NCT02374463|EG000|Reported Event|MMBI|Multimodality Balance Intervention (MMBI)
11226431|NCT02374463|EG001|Reported Event|Tai Chi|Tai Chi Intervention
11047743|NCT01290614|BG001|Baseline|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
11047744|NCT01290614|BG002|Baseline|Total|Total of all reporting groups
11047745|NCT01290614|FG000|Participant Flow|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
11047746|NCT01290614|FG001|Participant Flow|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
11047747|NCT01290614|OG000|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
11047748|NCT01290614|OG001|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
11047749|NCT01290614|EG000|Reported Event|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
11047750|NCT01290614|EG001|Reported Event|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
11047751|NCT01290627|BG000|Baseline|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
11047752|NCT01290627|BG001|Baseline|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
11047753|NCT01290627|BG002|Baseline|Control|Subjects with normal knees
11047754|NCT01290627|BG003|Baseline|Total|Total of all reporting groups
11047755|NCT01290627|FG000|Participant Flow|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
11047756|NCT01290627|FG001|Participant Flow|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
11047757|NCT01290627|FG002|Participant Flow|Control|Subjects with normal knees
11047758|NCT01290627|OG000|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
11047759|NCT01290627|OG001|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
11047760|NCT01290627|OG002|Outcome|Control|Subjects with normal knees
11047761|NCT01290627|EG000|Reported Event|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
11047762|NCT01290627|EG001|Reported Event|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
11047763|NCT01290627|EG002|Reported Event|Control|Subjects with normal knees
11047764|NCT01290640|BG000|Baseline|PFC RP TC3 TKA|
11047765|NCT01290640|BG001|Baseline|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
11047766|NCT01290640|BG002|Baseline|Total|Total of all reporting groups
11047767|NCT01290640|FG000|Participant Flow|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA
11047768|NCT01290640|FG001|Participant Flow|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
11047769|NCT01290640|OG000|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
11047770|NCT01290640|OG001|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
11047771|NCT01290640|EG000|Reported Event|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
11047772|NCT01290640|EG001|Reported Event|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
11047773|NCT01290666|BG000|Baseline|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
11047774|NCT01290666|FG000|Participant Flow|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
11047775|NCT01290666|OG000|Outcome|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
11047776|NCT01290666|EG000|Reported Event|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
11047777|NCT01290679|BG000|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047778|NCT01290679|BG001|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
11047779|NCT01290679|BG002|Baseline|Total|Total of all reporting groups
11047780|NCT01290679|FG000|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047781|NCT01290679|FG001|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
11047782|NCT01290679|OG000|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047783|NCT01290679|OG001|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
11047784|NCT01290679|EG000|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047785|NCT01290679|EG001|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
11047786|NCT01290731|BG000|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
11047787|NCT01290731|FG000|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
11047788|NCT01290731|OG000|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
11047789|NCT01290731|EG000|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
11047790|NCT01290757|BG000|Baseline|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
11047791|NCT01290757|BG001|Baseline|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
11047792|NCT01290757|BG002|Baseline|Total|Total of all reporting groups
11047793|NCT01290757|FG000|Participant Flow|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
11047794|NCT01290757|FG001|Participant Flow|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
11047795|NCT01290757|OG000|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
11047796|NCT01290757|OG001|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
11047797|NCT01290757|EG000|Reported Event|Qualicaps|Dabigatran 150mg in Qualicaps
11047798|NCT01290757|EG001|Reported Event|Capsugel|Dabigatran 150mg in Capsugel
11226432|NCT02374593|BG000|Baseline|Targeted Dosing|Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
11047799|NCT01290796|BG000|Baseline|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
11047800|NCT01290796|FG000|Participant Flow|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
11047801|NCT01290796|OG000|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
11047802|NCT01290796|EG000|Reported Event|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
11047803|NCT01290874|BG000|Baseline|Tiotropium|"Tiotropium bromide will be evaluated as a treatment for asthma.~Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment."
11047804|NCT01290874|BG001|Baseline|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
11047805|NCT01290874|BG002|Baseline|Total|Total of all reporting groups
11047806|NCT01290874|FG000|Participant Flow|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
11047807|NCT01290874|FG001|Participant Flow|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
11047808|NCT01290874|OG000|Outcome|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
11047809|NCT01290874|OG001|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
11047810|NCT01290874|OG000|Outcome|Tiotropium|"Tiotropium bromide will be evaluated as a treatment for asthma.~Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment."
11047811|NCT01290874|EG000|Reported Event|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
11047812|NCT01290874|EG001|Reported Event|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
11047813|NCT01290887|BG000|Baseline|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
11047814|NCT01290887|BG001|Baseline|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
11047815|NCT01290887|BG002|Baseline|Total|Total of all reporting groups
11047816|NCT01290887|FG000|Participant Flow|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
11047817|NCT01290887|FG001|Participant Flow|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
11047818|NCT01290887|OG000|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
11047819|NCT01290887|OG001|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
11047820|NCT01290887|OG002|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
11047821|NCT01290887|EG000|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
11047822|NCT01290913|BG000|Baseline|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
11047823|NCT01290913|FG000|Participant Flow|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
11047824|NCT01290913|OG000|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
11047825|NCT01290913|EG000|Reported Event|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
11047826|NCT01290952|BG000|Baseline|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
11047827|NCT01290952|BG001|Baseline|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
11047828|NCT01290952|BG002|Baseline|Total|Total of all reporting groups
11047829|NCT01290952|FG000|Participant Flow|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
11047830|NCT01290952|FG001|Participant Flow|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
11047831|NCT01290952|OG000|Outcome|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
11047832|NCT01290952|OG001|Outcome|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
11047833|NCT01290952|OG000|Outcome|On-pump Bypass Surgery|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
11047834|NCT01290952|OG001|Outcome|Off-pump Bypass Surgery|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
11047835|NCT01290952|EG000|Reported Event|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
11047836|NCT01290952|EG001|Reported Event|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
11047837|NCT01290978|BG000|Baseline|ChloraPrep , DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
10849048|NCT00293397|OG000|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|"Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.~doxorubicin hydrochloride: Doxorubicin eluting beads"
11047838|NCT01290978|FG000|Participant Flow|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
11047839|NCT01290978|OG000|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
11047840|NCT01290978|OG001|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
11047841|NCT01290978|EG000|Reported Event|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
10849049|NCT00293397|EG000|Reported Event|Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE)|"Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.~doxorubicin hydrochloride: Doxorubicin eluting beads"
10849050|NCT00293423|BG000|Baseline|Phase 1: Vaccine|Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
11047842|NCT01291017|BG000|Baseline|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
10849051|NCT00293423|BG001|Baseline|Phase 2: Vaccine|Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
10849052|NCT00293423|BG002|Baseline|Total|Total of all reporting groups
10849053|NCT00293423|FG000|Participant Flow|Phase 1: Vaccine|Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
11047843|NCT01291017|FG000|Participant Flow|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
11047844|NCT01291017|OG000|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
11047845|NCT01291017|EG000|Reported Event|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
11047846|NCT01291056|BG000|Baseline|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
11047847|NCT01291056|BG001|Baseline|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
11047848|NCT01291056|BG002|Baseline|Total|Total of all reporting groups
11047849|NCT01291056|FG000|Participant Flow|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
11047850|NCT01291056|FG001|Participant Flow|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
11047851|NCT01291056|OG000|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
11047852|NCT01291056|OG001|Outcome|Placebo|Placebo
11047853|NCT01291056|EG000|Reported Event|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
11047854|NCT01291056|EG001|Reported Event|Placebo, Then Clomiphene Citrate|Placebo daily, then Clomiphene Citrate 50 milligrams daily
11047855|NCT01291108|BG000|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
11047856|NCT01291108|BG001|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
11047857|NCT01291108|BG002|Baseline|Bimatoprost Followed by Bimatoprost + AGN-210669|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + AGN-210669 applied as 1 drop of each treatment in both eyes every evening for Month 2.
11047858|NCT01291108|BG003|Baseline|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
11047859|NCT01291108|BG004|Baseline|Total|Total of all reporting groups
11047860|NCT01291108|FG000|Participant Flow|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
11047861|NCT01291108|FG001|Participant Flow|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
11047862|NCT01291108|FG002|Participant Flow|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
11047863|NCT01291108|FG003|Participant Flow|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
11047864|NCT01291108|FG004|Participant Flow|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
11047865|NCT01291108|FG005|Participant Flow|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
11047866|NCT01291108|OG000|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
11047867|NCT01291108|OG001|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
11047868|NCT01291108|OG002|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of 'AGN-210669 0.05% + bimatoprost' and 'bimatoprost + AGN-210669 0.05%'. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
11047869|NCT01291108|EG000|Reported Event|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
11047870|NCT01291108|EG001|Reported Event|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
11226433|NCT02374593|BG001|Baseline|Historical Control|Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
11226434|NCT02374593|BG002|Baseline|Total|Total of all reporting groups
11226435|NCT02374593|FG000|Participant Flow|Targeted Dosing|Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
11226436|NCT02374593|FG001|Participant Flow|Historical Control|Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
11226437|NCT02374593|OG000|Outcome|Targeted Dosing|Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
11226438|NCT02374593|OG001|Outcome|Historical Control|Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
11226439|NCT02374593|OG000|Outcome|Patients With Athyreosis|"Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy at 15 mcg/kg for athyreosis.~Levothyroxine: Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.~Ultrasound"
11226440|NCT02374593|OG001|Outcome|Patients With Dysgenetic Thyroids|patients with dysgenetic thyroids
11047871|NCT01291108|EG002|Reported Event|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
11226441|NCT02374593|OG002|Outcome|Patients With Eutopic Thyroids|patients with eutopic thyroids
11226442|NCT02374593|OG003|Outcome|Historical Controls|see title
11226443|NCT02374593|EG000|Reported Event|Targeted Dosing|Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
11226444|NCT02374593|EG001|Reported Event|Historical Control|Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
11047872|NCT01291108|EG003|Reported Event|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
11047873|NCT01291108|EG004|Reported Event|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
11226445|NCT02374671|BG000|Baseline|Implantation-Non-Randomized|"Subjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria.~VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months."
11226446|NCT02374671|BG001|Baseline|Implantation-Randomized|"Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. VisAbility micro inserts surgically implanted in the eyes. Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.~VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months."
11226447|NCT02374671|BG002|Baseline|Deferred Implantion-Randomized|Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
11226448|NCT02374671|BG003|Baseline|Total|Total of all reporting groups
11226449|NCT02374671|FG000|Participant Flow|Implantation-Non-Randomzied|"Subjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria.~VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months."
11226450|NCT02374671|FG001|Participant Flow|Implantation-Randomized|"Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. VisAbility micro inserts surgically implanted in the eyes. Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.~VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months."
11226451|NCT02374671|FG002|Participant Flow|Deferred Implantion-Randomized|Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
11226452|NCT02374671|OG000|Outcome|Overall Study Population|A total of 360 subjects at 14 sites received implantation of VisiAbility micro inserts and were followed for 24 months post surgical. As per the protocol, the primary eye is the unit of analysis and was used for primary endpoint analysis. Fellow eyes were followed for safety and summarized separately. The primary eyes of subjects participating in the randomized sub-study were analyzed separately, though, they were also considered part of the overall study if they received implantation of the micro inserts.
11226453|NCT02374671|OG000|Outcome|Implantation-Randomized|"Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. VisAbility micro inserts surgically implanted in the eyes. Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.~VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months."
11226454|NCT02374671|OG001|Outcome|Deferred Implantion-Randomized|Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
11348972|NCT04137627|OG001|Outcome|Placebo|"The group received standard treatment with the oral administration of Placebo~Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy"
11047874|NCT01291108|EG005|Reported Event|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
11047875|NCT01291160|BG000|Baseline|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
11047876|NCT01291160|BG001|Baseline|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
11047877|NCT01291160|BG002|Baseline|Total|Total of all reporting groups
11047878|NCT01291160|FG000|Participant Flow|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
11047879|NCT01291160|FG001|Participant Flow|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
11047880|NCT01291160|OG000|Outcome|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
11047881|NCT01291160|OG001|Outcome|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
11047882|NCT01291160|EG000|Reported Event|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
11047883|NCT01291160|EG001|Reported Event|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
11047884|NCT01291173|BG000|Baseline|Placebo|Placebo capsule taken once daily for up to 11 weeks
11047885|NCT01291173|BG001|Baseline|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
11047886|NCT01291173|BG002|Baseline|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
11047887|NCT01291173|BG003|Baseline|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
11047888|NCT01291173|BG004|Baseline|Total|Total of all reporting groups
11047889|NCT01291173|FG000|Participant Flow|Placebo|Placebo capsule taken once daily for up to 11 weeks
11047890|NCT01291173|FG001|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
11047891|NCT01291173|FG002|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
11047892|NCT01291173|FG003|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
11047893|NCT01291173|OG000|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
11047894|NCT01291173|OG001|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
11047895|NCT01291173|OG002|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
11047896|NCT01291173|OG003|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
11047897|NCT01291173|EG000|Reported Event|Placebo|Placebo capsule taken once daily for up to 11 weeks
11047898|NCT01291173|EG001|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
11047899|NCT01291173|EG002|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
11047900|NCT01291173|EG003|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
11047901|NCT01291225|BG000|Baseline|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
11047902|NCT01291225|BG001|Baseline|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
11047903|NCT01291225|BG002|Baseline|Total|Total of all reporting groups
11047904|NCT01291225|FG000|Participant Flow|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
11348973|NCT04137627|EG000|Reported Event|Melatonin|"The group received standard treatment with the oral administration of Melatonin~Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect."
11047905|NCT01291225|FG001|Participant Flow|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
11047906|NCT01291225|OG000|Outcome|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
11047907|NCT01291225|OG001|Outcome|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
11047908|NCT01291225|OG000|Outcome|Playground--Chillicothe|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
11047909|NCT01291225|OG001|Outcome|Playground--Circleville|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
11047910|NCT01291225|OG002|Outcome|Farms--Ross County|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
11047911|NCT01291225|OG003|Outcome|Farms--Pickaway/Morrow Counties|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
11047912|NCT01291225|EG000|Reported Event|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
11047913|NCT01291225|EG001|Reported Event|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
11047914|NCT01291264|BG000|Baseline|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
11047915|NCT01291264|FG000|Participant Flow|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
11047916|NCT01291264|OG000|Outcome|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
11047917|NCT01291264|EG000|Reported Event|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
11047918|NCT01291277|BG000|Baseline|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
11047919|NCT01291277|BG001|Baseline|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
11047920|NCT01291277|BG002|Baseline|Total|Total of all reporting groups
11047921|NCT01291277|FG000|Participant Flow|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
11047922|NCT01291277|FG001|Participant Flow|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
11047923|NCT01291277|OG000|Outcome|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
11047924|NCT01291277|OG001|Outcome|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
11047925|NCT01291277|EG000|Reported Event|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
11047926|NCT01291277|EG001|Reported Event|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
11047927|NCT01291498|BG000|Baseline|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
11047928|NCT01291498|FG000|Participant Flow|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
11047929|NCT01291498|OG000|Outcome|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
11047930|NCT01291498|OG000|Outcome|HIFU Treatment|Ablation of the parathyroid gland by HIFU Treatment
11047931|NCT01291498|OG000|Outcome|HIFU Treatment|Allsubjects are planned to have HIFU Treatment
11047932|NCT01291498|EG000|Reported Event|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
11348974|NCT04137627|EG001|Reported Event|Placebo|"The group received standard treatment with the oral administration of Placebo~Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy"
11047933|NCT01291784|BG000|Baseline|Phase 1 MF Subjects|3 subjects were enrolled in the study. The three subjects were treated at a GC1008 dose level of 1 mg/kg given intravenously over approximately 60 minutes and then repeated every 28 days for a total of 6 cycles in the core study period and then an additional 6 cycles in an extension phase.
11047934|NCT01291784|FG000|Participant Flow|Sub A|Subject A
11047935|NCT01291784|FG001|Participant Flow|Sub B|Subject B
11047936|NCT01291784|FG002|Participant Flow|Sub C|Subject C
11047937|NCT01291784|OG000|Outcome|Sub A|Subject A
11047938|NCT01291784|OG001|Outcome|Sub B|Subject B
11047939|NCT01291784|OG002|Outcome|Sub C|Subject C
11047940|NCT01291784|EG000|Reported Event|Sub A|Subject A
11047941|NCT01291784|EG001|Reported Event|Sub B|Subject B
11047942|NCT01291784|EG002|Reported Event|Sub C|Subject C
11047943|NCT01291836|BG000|Baseline|Enrollment Group-No Treatment Arms.|All subjects underwent the same protocol procedures no stratification.
11047944|NCT01291836|FG000|Participant Flow|Enrollment Group|Subjects with sufficient data to be included in the analysis.
11047945|NCT01291836|FG001|Participant Flow|Subjects Enrolled But Not Included in the Analysis.|Subjects that were consented and some study procedures completed but did not have required study procedures completed and subsequent data available for inclusion in the primary analysis.
11337710|NCT03591406|EG000|Reported Event|Ferric Carboxymaltose (FCM)|"Participants treated with FCM given by IV injection or drip infusion~Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection~Strength: 10 mL vials containing 500 mg iron per vial~Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening)~Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline)~Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15."
11047946|NCT01291836|OG000|Outcome|Enrollment Group|Subjects enrolled in the study and completing required procedures to be included in the primary analysis.
11047947|NCT01291836|OG000|Outcome|Enrollment Group|Subjects enrolled and completing the required study procedures for the primary analysis.
11047948|NCT01291836|EG000|Reported Event|Enrollment Group|Subjects enrolled in the study and completing study procedures required for the analysis.
11047949|NCT01291836|EG001|Reported Event|Non-participating Group|Subjects consented and/or enrolled in the study but not completing study procedures required for the analysis.
11047950|NCT01292005|BG000|Baseline|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
11047951|NCT01292005|BG001|Baseline|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
11047952|NCT01292005|BG002|Baseline|Total|Total of all reporting groups
11047953|NCT01292005|FG000|Participant Flow|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
11047954|NCT01292005|FG001|Participant Flow|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
11047955|NCT01292005|OG000|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
11047956|NCT01292005|OG001|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
11047957|NCT01292005|EG000|Reported Event|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
11047958|NCT01292005|EG001|Reported Event|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
11047959|NCT01292057|BG000|Baseline|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
11047960|NCT01292057|BG001|Baseline|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
11047961|NCT01292057|BG002|Baseline|Total|Total of all reporting groups
11047962|NCT01292057|FG000|Participant Flow|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
11047963|NCT01292057|FG001|Participant Flow|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
11047964|NCT01292057|OG000|Outcome|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
11047965|NCT01292057|OG001|Outcome|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
11047966|NCT01292057|EG000|Reported Event|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
11047967|NCT01292057|EG001|Reported Event|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
11047968|NCT01292135|BG000|Baseline|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
11047969|NCT01292135|BG001|Baseline|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
11047970|NCT01292135|BG002|Baseline|Total|Total of all reporting groups
11047971|NCT01292135|FG000|Participant Flow|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|"PCI-32765: 420 mg daily~FCR:~Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1(Cycle 2 to Cycle 6).~Fludarabine: 25 mg/m2/day for 3 days (Days 1 to 3) of each cycle~Cyclophosphamide: 250 mg/m2/day for 3 days (Days 1 to 3) of each cycle (Up to 6 Cycle)"
11047972|NCT01292135|FG001|Participant Flow|PCI-32765 Plus Bendamustine/Rituximab (BR)|"PCI-32765: 420 mg daily~BR:~Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1 (Cycle 2 to Cycle 6).~Bendamustine; 70 mg/m² on Day 1 and 2 of each cycle (Up to 6 Cycles)"
11047973|NCT01292135|OG000|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
11047974|NCT01292135|OG001|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
11047975|NCT01292135|OG001|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
11047976|NCT01292135|OG001|Outcome|PCI- 32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
11047977|NCT01292135|EG000|Reported Event|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
11047978|NCT01292135|EG001|Reported Event|PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
11047979|NCT01292187|BG000|Baseline|rsCT Tablets|Patients who received oral calcitonin as an active treatment
11047980|NCT01292187|BG001|Baseline|Placebo Tablets|Patients who did not receive any active treatment, just placebo
11047981|NCT01292187|BG002|Baseline|Total|Total of all reporting groups
11047982|NCT01292187|FG000|Participant Flow|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
11047983|NCT01292187|FG001|Participant Flow|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
11047984|NCT01292187|OG000|Outcome|Oral Calcitonin Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
11047985|NCT01292187|OG001|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
11047986|NCT01292187|OG000|Outcome|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
11047987|NCT01292187|EG000|Reported Event|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
11047988|NCT01292187|EG001|Reported Event|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
11047989|NCT01292226|BG000|Baseline|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
11047990|NCT01292226|FG000|Participant Flow|Mycophenolate Mofetil (MMF) Monotherapy|Participants received an initial dose of MMF 1 gram (g), orally (PO), twice per day (BID), started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
11047991|NCT01292226|OG000|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
11047992|NCT01292226|EG000|Reported Event|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
11047993|NCT01292239|BG000|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047994|NCT01292239|BG001|Baseline|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
11047995|NCT01292239|BG002|Baseline|Total|Total of all reporting groups
11047996|NCT01292239|FG000|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047997|NCT01292239|FG001|Participant Flow|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
11047998|NCT01292239|OG000|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11047999|NCT01292239|OG001|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
11048000|NCT01292239|EG000|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
11048001|NCT01292239|EG001|Reported Event|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
11048002|NCT01292252|BG000|Baseline|Treatment: Forteo, Terapeptide 20 ug|"Forteo, Terapeptide 20 ug subcutaneous injection~teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks"
11048003|NCT01292252|BG001|Baseline|Control: Saline Placebo|"Saline placebo~Placebo: Saline solution"
11048004|NCT01292252|BG002|Baseline|Total|Total of all reporting groups
11048005|NCT01292252|FG000|Participant Flow|Treatment: Forteo, Terapeptide 20 ug|"Forteo, Terapeptide 20 ug subcutaneous injection~teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks"
11048006|NCT01292252|FG001|Participant Flow|Control: Saline Placebo|"Saline placebo~Placebo: Saline solution"
11048007|NCT01292252|OG000|Outcome|Treatment: Forteo, Terapeptide 20 ug|"Forteo, Terapeptide 20 ug subcutaneous injection~teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks"
11048008|NCT01292252|OG001|Outcome|Control: Saline Placebo|"Saline placebo~Placebo: Saline solution"
11048009|NCT01292252|EG000|Reported Event|Treatment: Forteo, Terapeptide 20 ug|"Forteo, Terapeptide 20 ug subcutaneous injection~teriparatide: Teriparatide 20 ug subcutaneous injection daily for 12 weeks"
11048010|NCT01292252|EG001|Reported Event|Control: Saline Placebo|"Saline placebo~Placebo: Saline solution"
11048011|NCT01292304|BG000|Baseline|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
11048012|NCT01292304|FG000|Participant Flow|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
11048013|NCT01292304|OG000|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
11048014|NCT01292304|EG000|Reported Event|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
11048015|NCT01292447|BG000|Baseline|Control Group|"Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.~Placebo gel: Inert gel x 1"
11048016|NCT01292447|BG001|Baseline|Study Group|"Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.~2% lidocaine gel: 120mg lidocaine x 1"
11048017|NCT01292447|BG002|Baseline|Total|Total of all reporting groups
11048018|NCT01292447|FG000|Participant Flow|Control Group|"Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.~Placebo gel: Inert gel x 1"
11048019|NCT01292447|FG001|Participant Flow|Study Group|"Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.~2% lidocaine gel: 120mg lidocaine x 1"
11048020|NCT01292447|OG000|Outcome|Control Group|"Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.~Placebo gel: Inert gel x 1"
11048021|NCT01292447|OG001|Outcome|Study Group|"Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.~2% lidocaine gel: 120mg lidocaine x 1"
11048022|NCT01292447|EG000|Reported Event|Control Group|"Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.~Placebo gel: Inert gel x 1"
11048023|NCT01292447|EG001|Reported Event|Study Group|"Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.~2% lidocaine gel: 120mg lidocaine x 1"
11048024|NCT01292473|BG000|Baseline|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
11048025|NCT01292473|BG001|Baseline|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
11048026|NCT01292473|BG002|Baseline|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
11048027|NCT01292473|BG003|Baseline|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
11048028|NCT01292473|BG004|Baseline|Total|Total of all reporting groups
11048029|NCT01292473|FG000|Participant Flow|Placebo|Placebo subcutaneously (sc) every 4 weeks.
11048030|NCT01292473|FG001|Participant Flow|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
11048031|NCT01292473|FG002|Participant Flow|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
11048032|NCT01292473|FG003|Participant Flow|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
11048033|NCT01292473|OG000|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
11048034|NCT01292473|OG001|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
11048035|NCT01292473|OG002|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
11048036|NCT01292473|OG003|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
11048037|NCT01292473|OG000|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
11048038|NCT01292473|OG001|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
11048039|NCT01292473|OG002|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
11048040|NCT01292473|OG003|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
11048041|NCT01292473|EG000|Reported Event|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
11048042|NCT01292473|EG001|Reported Event|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
11048043|NCT01292473|EG002|Reported Event|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
11048044|NCT01292473|EG003|Reported Event|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
11048045|NCT01292486|BG000|Baseline|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
11048046|NCT01292486|FG000|Participant Flow|All Per Protocol Patients|This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
11048047|NCT01292486|OG000|Outcome|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
11048048|NCT01292486|OG000|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
11048049|NCT01292486|EG000|Reported Event|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
11048050|NCT01292538|BG000|Baseline|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
11048051|NCT01292538|BG001|Baseline|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
11048052|NCT01292538|BG002|Baseline|Total|Total of all reporting groups
11048053|NCT01292538|FG000|Participant Flow|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
11048054|NCT01292538|FG001|Participant Flow|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
11048055|NCT01292538|OG000|Outcome|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
11048056|NCT01292538|OG001|Outcome|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
11048057|NCT01292538|EG000|Reported Event|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
11048058|NCT01292538|EG001|Reported Event|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
11048059|NCT01292603|BG000|Baseline|Part 1: Rituximab SC 1400 Milligrams (mg)|Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048060|NCT01292603|BG001|Baseline|Part 1: Rituximab SC 1600 mg|Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048061|NCT01292603|BG002|Baseline|Part 1: Rituximab SC 1870 mg|Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048062|NCT01292603|BG003|Baseline|Part 2 : Rituximab IV 500 mg/m^2|Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048063|NCT01292603|BG004|Baseline|Part 2: Rituximab SC 1600 mg|Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048064|NCT01292603|BG005|Baseline|Total|Total of all reporting groups
11048065|NCT01292603|FG000|Participant Flow|Part 1: Rituximab SC 1400 Milligrams (mg)|Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 milligrams per square meter (mg/m^2) on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048066|NCT01292603|FG001|Participant Flow|Part 1: Rituximab SC 1600 mg|Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11149166|NCT01869075|OG002|Outcome|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11048067|NCT01292603|FG002|Participant Flow|Part 1: Rituximab SC 1870 mg|Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048068|NCT01292603|FG003|Participant Flow|Part 1: No SC Dose Received|These participants were withdrawn prior to SC treatment.
11048069|NCT01292603|FG004|Participant Flow|Part 2 : Rituximab IV 500 mg/m^2|Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048070|NCT01292603|FG005|Participant Flow|Part 2: Rituximab SC 1600 mg|Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048071|NCT01292603|OG000|Outcome|Part 1: Rituximab SC|Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048072|NCT01292603|OG000|Outcome|Part 2 : Rituximab IV 500 mg/m^2|Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048073|NCT01292603|OG001|Outcome|Part 2: Rituximab SC 1600 mg|Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048074|NCT01292603|OG000|Outcome|Part 1: Rituximab SC 1400 mg|Participant could have been enrolled any time during treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048075|NCT01292603|OG001|Outcome|Part 1: Rituximab SC 1600 mg|Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048076|NCT01292603|OG002|Outcome|Part 1: Rituximab SC 1870 mg|Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048077|NCT01292603|OG000|Outcome|Part 1: Rituximab SC|Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048078|NCT01292603|OG000|Outcome|Part 1: Rituximab SC 1400 Milligrams (mg)|Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048079|NCT01292603|OG003|Outcome|Part 1: Rituximab SC 1000 mg|"One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.~Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3)."
11048080|NCT01292603|OG004|Outcome|Part 1: No SC Dose Received|These participants were withdrawn prior to SC treatment.
11048081|NCT01292603|OG000|Outcome|Part 1: Rituximab SC 1400 mg|Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048082|NCT01292603|OG003|Outcome|Rituximab SC 1000 mg|Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048083|NCT01292603|EG000|Reported Event|Part 1: Rituximab SC 1400 mg|Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048084|NCT01292603|EG001|Reported Event|Part 1: Rituximab SC 1600 mg|Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048085|NCT01292603|EG002|Reported Event|Part 1: Rituximab SC 1870 mg|PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048086|NCT01292603|EG003|Reported Event|Part 1: Rituximab SC 1000 mg|"One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.~Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3)."
11048087|NCT01292603|EG004|Reported Event|Part 1: No SC Dose Received|These participants were withdrawn prior to SC treatment.
11048088|NCT01292603|EG005|Reported Event|Part 2 : Rituximab IV 500 mg/m^2|Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048089|NCT01292603|EG006|Reported Event|Part 2: Rituximab SC 1600 mg|Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1-3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1-3 (or as an oral dose of 150 mg/m^2 on Days 1-5 or 200-250 mg/m^2 on Days 1-3).
11048090|NCT01292629|BG000|Baseline|iSert® 251 Intraocular Lens|Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects.
11048091|NCT01292629|FG000|Participant Flow|iSert 251: iSert 251 Intraocular Lens|Implantation with the iSert® 251 Intraocular lens
11048092|NCT01292629|OG000|Outcome|iSert 251: iSert 251 Intraocular Lens|Eligible subjects underwent phacoemulsification cataract extraction surgery and were implanted with the iSert® Intraocular Lens. Study observation was up to 271 days.
11048093|NCT01292629|OG000|Outcome|iSert 251 Aphakik IOL|iSert 251: iSert 251 intraocular lens
11048094|NCT01292629|EG000|Reported Event|iSert 251: iSert 251 Intraocular Lens|Subjects who underwent phacoemulsification cataract extraction surgery who were implanted with the iSert aphakic intraocular lens.
11048095|NCT01292642|BG000|Baseline|Treatment|CBT plus NRT
11048096|NCT01292642|FG000|Participant Flow|Treatment|Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
11048097|NCT01292642|OG000|Outcome|Baseline - Cigarettes Per Day|
11048098|NCT01292642|OG001|Outcome|PostTreatment - Cigarettes Per Day|CBT plus NRT
11048099|NCT01292642|OG000|Outcome|Baseline - Cannabis Inhalations Per Day|CBT plus NRT
11348975|NCT04136145|BG000|Baseline|Belimumab 200 mg IV|Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.
11048100|NCT01292642|OG001|Outcome|Post Treatment - Cannabis Inhalations Per Day|
11048101|NCT01292642|OG000|Outcome|Treatment|CBT plus NRT
11048102|NCT01292642|EG000|Reported Event|Treatment|CBT plus NRT
11048103|NCT01292746|BG000|Baseline|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
11048104|NCT01292746|FG000|Participant Flow|Erchonia MLS|Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light.
11048105|NCT01292746|OG000|Outcome|Erchonia MLS|Erchonia MLS: The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
11048106|NCT01292746|EG000|Reported Event|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
11048107|NCT01292798|BG000|Baseline|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
11048108|NCT01292798|FG000|Participant Flow|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
11048109|NCT01292798|OG000|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
11048110|NCT01292798|EG000|Reported Event|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
11048111|NCT01292837|BG000|Baseline|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
11048112|NCT01292837|FG000|Participant Flow|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
11048113|NCT01292837|OG000|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
11048114|NCT01292837|EG000|Reported Event|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
11048115|NCT01292876|BG000|Baseline|Extracellular Matrix|"Implantation of Extracellular Matrix~Extracellular Matrix: Extracellular Matrix"
11048116|NCT01292876|FG000|Participant Flow|Extracellular Matrix|Overall number of participants for which baseline characteristics were measured for all baseline measures reported..
11048117|NCT01292876|OG000|Outcome|Extracellular Matrix|Participants for which final characteristics and functional evaluations were measured for all measures reported.
11048118|NCT01292876|OG000|Outcome|Extracellular Matrix|Overall number of participants for which characteristics were measured for all measures reported..
11048119|NCT01292876|EG000|Reported Event|Extracellular Matrix_Control|Control (prior to implantation of ECM)
11048120|NCT01292876|EG001|Reported Event|Extracellular Matrix_Exp|Experimental group; post implantation of ECM
11048121|NCT01292928|BG000|Baseline|Innova Stent|Stent implantation into SFA/PPA
11348976|NCT04136145|BG001|Baseline|Belimumab 200 mg SC|Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
11048122|NCT01292928|FG000|Participant Flow|Innova Stent|Stent implantation into Superficial Femoral Artery (SFA) / Proximal Popliteal Artery (PPA)
11048123|NCT01292928|OG000|Outcome|Innova Stent|Stent implantation into SFA/PPA
11048124|NCT01292928|OG000|Outcome|Innova Stent Core Matrix (20-150 mm)|Core Matrix Stent implantation into SFA/PPA
11048125|NCT01292928|OG001|Outcome|Innova Stent Entire Matrix (20-200 mm)|Entire Matrix Stent implantation into SFA/PPA
11048126|NCT01292928|EG000|Reported Event|Innova Stent|Stent implantation into SFA/PPA
11048127|NCT01293006|BG000|Baseline|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of, at least, 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
11048128|NCT01293006|BG001|Baseline|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of MK-suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
11048129|NCT01293006|BG002|Baseline|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
11048130|NCT01293006|BG003|Baseline|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
11048131|NCT01293006|BG004|Baseline|Total|Total of all reporting groups
11048132|NCT01293006|FG000|Participant Flow|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
11048133|NCT01293006|FG001|Participant Flow|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
11348977|NCT04136145|BG002|Baseline|Total|Total of all reporting groups
11048134|NCT01293006|FG002|Participant Flow|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
11048135|NCT01293006|FG003|Participant Flow|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
11048136|NCT01293006|OG000|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg oral dose of suvorexant.
11048137|NCT01293006|OG001|Outcome|Placebo|Participants administered placebo.
11048138|NCT01293006|OG000|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
11048139|NCT01293006|OG001|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
11048140|NCT01293006|OG002|Outcome|Placebo|Participants administered placebo.
11048141|NCT01293006|OG000|Outcome|Suvorexant (30 mg or 40 mg)|Participants receiving either a 40-mg or 30-mg dose of suvorexant.
11048142|NCT01293006|OG001|Outcome|Placebo|Participants receiving placebo.
11048143|NCT01293006|OG000|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or 30-mg dose of suvorexant.
11048144|NCT01293006|OG000|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
11048145|NCT01293006|OG000|Outcome|Suvorexant (40 mg or 30 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
11048146|NCT01293006|EG000|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
11048147|NCT01293006|EG001|Reported Event|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
11048148|NCT01293006|EG002|Reported Event|Placebo|Participants administered placebo.
11048149|NCT01293032|BG000|Baseline|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
11048150|NCT01293032|BG001|Baseline|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
11048151|NCT01293032|BG002|Baseline|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
11048152|NCT01293032|BG003|Baseline|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
11048153|NCT01293032|BG004|Baseline|Total|Total of all reporting groups
11048154|NCT01293032|FG000|Participant Flow|Group 1 (RS < 11)|"Patients with a RS of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
11048155|NCT01293032|FG001|Participant Flow|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
11048156|NCT01293032|FG002|Participant Flow|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
11048157|NCT01293032|FG003|Participant Flow|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
11048158|NCT01293032|OG000|Outcome|Group 2 (RS 11-25)|Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.
11149167|NCT01869075|OG003|Outcome|MGS - Usual Care|Usual Care as provided at the hospital
11348978|NCT04136145|FG000|Participant Flow|Belimumab 200 mg IV|Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.
11048159|NCT01293032|EG000|Reported Event|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
11048160|NCT01293032|EG001|Reported Event|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
11048161|NCT01293032|EG002|Reported Event|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
11048162|NCT01293032|EG003|Reported Event|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
11048163|NCT01293084|BG000|Baseline|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
11048164|NCT01293084|FG000|Participant Flow|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
11048165|NCT01293084|OG000|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
11048166|NCT01293084|OG001|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
11048167|NCT01293084|EG000|Reported Event|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
11048168|NCT01293084|EG001|Reported Event|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
11048169|NCT01293240|BG000|Baseline|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
11048170|NCT01293240|FG000|Participant Flow|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
10846964|NCT00281463|EG000|Reported Event|Pushrim Activated Power Assist Wheelchair|"Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
11048171|NCT01293240|OG000|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
11048172|NCT01293240|EG000|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
11048173|NCT01293396|BG000|Baseline|Overall Study|20 patients with type 2 diabetes receive insulin aspart, premixed biphasic insulin 30 and premixed biphasic insulin aspart 70 in randomized order.
11048174|NCT01293396|FG000|Participant Flow|Group 1|Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period.
11048175|NCT01293396|FG001|Participant Flow|Group 2|Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period
11048176|NCT01293396|FG002|Participant Flow|Group 3|Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period.
11048177|NCT01293396|OG000|Outcome|Biphasic Insulin Aspart 30|Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
11048178|NCT01293396|OG001|Outcome|Biphasic Insulin Aspart 70|Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
11048179|NCT01293396|OG002|Outcome|Insulin Aspart|Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
11048180|NCT01293396|EG000|Reported Event|Biphasic Insulin Aspart 30|Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
11048181|NCT01293396|EG001|Reported Event|Biphasic Insulin Aspart 70|Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
11048182|NCT01293396|EG002|Reported Event|Insulin Aspart|Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
11149168|NCT01869075|OG004|Outcome|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11048183|NCT01293539|BG000|Baseline|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.~Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
11048184|NCT01293539|FG000|Participant Flow|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.~Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
11048185|NCT01293539|OG000|Outcome|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.~Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
11048186|NCT01293539|EG000|Reported Event|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.~Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
11048187|NCT01293695|BG000|Baseline|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy (HRT)~Hypnosis: Hypnosis relaxation in five weekly sessions"
11048188|NCT01293695|BG001|Baseline|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
11048189|NCT01293695|BG002|Baseline|Total|Total of all reporting groups
11048190|NCT01293695|FG000|Participant Flow|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
11048191|NCT01293695|FG001|Participant Flow|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
11048192|NCT01293695|OG000|Outcome|Hypnosis|"Received 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
11048193|NCT01293695|OG001|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
11048194|NCT01293695|OG000|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
11048195|NCT01293695|OG000|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions."
11348979|NCT04136145|FG001|Participant Flow|Belimumab 200 mg SC|Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
11048196|NCT01293695|OG000|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
11048197|NCT01293695|EG000|Reported Event|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
11048198|NCT01293695|EG001|Reported Event|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
11048199|NCT01293825|BG000|Baseline|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
11048200|NCT01293825|FG000|Participant Flow|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
11048201|NCT01293825|OG000|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
11048202|NCT01293825|EG000|Reported Event|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
11048203|NCT01293968|BG000|Baseline|Ibuprofen, Diphenhydramine and Aluminium MgS|
11048204|NCT01293968|BG001|Baseline|Diphenhydramine and Aluminium MgS|
11048205|NCT01293968|BG002|Baseline|Total|Total of all reporting groups
11048206|NCT01293968|FG000|Participant Flow|Ibuprofen, Diphenhydramine and Aluminium MgS|
11048207|NCT01293968|FG001|Participant Flow|Diphenhydramine and Aluminium MgS|
11048208|NCT01293968|OG000|Outcome|Ibuprofen, Diphenhydramine and Aluminium MgS|the group received the study solution containing 5cc ibuprofen 100mg, 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
11048209|NCT01293968|OG001|Outcome|Diphenhydramine and Aluminium MgS|the group received the placebo solution containing 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
11048210|NCT01293968|EG000|Reported Event|Ibuprofen, Diphenhydramine and Aluminium MgS|
11048211|NCT01293968|EG001|Reported Event|Diphenhydramine and Aluminium MgS|
11048212|NCT01294098|BG000|Baseline|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
11048213|NCT01294098|BG001|Baseline|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
11048214|NCT01294098|BG002|Baseline|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
11048215|NCT01294098|BG003|Baseline|Total|Total of all reporting groups
11048216|NCT01294098|FG000|Participant Flow|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
11048217|NCT01294098|FG001|Participant Flow|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
11048218|NCT01294098|FG002|Participant Flow|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
11048219|NCT01294098|OG000|Outcome|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
11048220|NCT01294098|OG001|Outcome|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
11048221|NCT01294098|OG002|Outcome|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
11048222|NCT01294098|EG000|Reported Event|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
11048223|NCT01294098|EG001|Reported Event|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
11048224|NCT01294098|EG002|Reported Event|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
11048225|NCT01294150|BG000|Baseline|UroLift System|Average of 4.9 implants per prostate implanted. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction.
11048226|NCT01294150|BG001|Baseline|Cystoscopy|Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure.
11048227|NCT01294150|BG002|Baseline|Total|Total of all reporting groups
11048228|NCT01294150|FG000|Participant Flow|UroLift System|The treatment group subjects underwent the UroLift (UL)system procedure. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to be retreated with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months were considered treatment failures, but started their follow-up schedule over. All subjects will be followed at a minimum of 5 years per the assessment schedule.
11048229|NCT01294150|FG001|Participant Flow|Cystoscopy (Control/Sham)|The control group subjects underwent a cystoscopy procedure. The subject was blinded as to whether he was randomized to the control or treatment group. Unblinding occurred at 3 months post procedure after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo procedure with the UroLift system, provided he met the inclusion and exclusion criteria. Subjects crossing over are then to be followed for 5 years post-treatment. If subject did not crossover, his participation was not required beyond the 12 month visit.
11048230|NCT01294150|OG000|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
11048231|NCT01294150|OG000|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
11048232|NCT01294150|OG001|Outcome|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
11149169|NCT01869075|OG005|Outcome|HFS - Usual Care|Usual Care as provided at the hospital
11149170|NCT01869075|EG000|Reported Event|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11048233|NCT01294150|EG000|Reported Event|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
11048234|NCT01294150|EG001|Reported Event|Crossover|Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
11048235|NCT01294150|EG002|Reported Event|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
11048236|NCT01294163|BG000|Baseline|Xenon|Anesthetic agent before and after CPB: xenon
11048237|NCT01294163|BG001|Baseline|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
11048238|NCT01294163|BG002|Baseline|TIVA|Anesthetic agent before and after CPB: propofol
11048239|NCT01294163|BG003|Baseline|Total|Total of all reporting groups
11048240|NCT01294163|FG000|Participant Flow|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
11048241|NCT01294163|FG001|Participant Flow|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
11226836|NCT02378402|EG000|Reported Event|Unstable HF Group|"Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF<50%. Proton (1H-) magnetic resonance (MR) spectroscopy.~Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value."
11048242|NCT01294163|FG002|Participant Flow|TIVA|Anesthetic agent before and after CPB: propofol
11048243|NCT01294163|OG000|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
11048244|NCT01294163|OG001|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
11048245|NCT01294163|EG000|Reported Event|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
11048246|NCT01294163|EG001|Reported Event|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
11048247|NCT01294163|EG002|Reported Event|TIVA|Anesthetic agent before and after CPB: propofol
11048248|NCT01294228|BG000|Baseline|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
11048249|NCT01294228|FG000|Participant Flow|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
11048250|NCT01294228|OG000|Outcome|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
11048251|NCT01294228|EG000|Reported Event|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
11048252|NCT01294241|BG000|Baseline|All Study Participants|One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control.
11048253|NCT01294241|FG000|Participant Flow|All Study Participants|One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control (intra-individual comparison).
11048254|NCT01294241|OG000|Outcome|All Study Participants|Intra-individual comparison of two treatments: One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as standard of care control.
11048255|NCT01294241|OG000|Outcome|Oleogel-S10 and Non-adhesive Wound Dressing|One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing.
11048256|NCT01294241|OG001|Outcome|Non-adhesive Wound Dressing Only|The other half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with non-adhesive wound Dressing only as control.
11048257|NCT01294241|EG000|Reported Event|Safety Population|All participants who received at least 1 dose of Oleogel-S10 were included in the safety population. All adverse events were reported for all study participants. Localized adverse events were not separately reported by intervention.
11048258|NCT01294267|BG000|Baseline|Circulatory Support System|Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.
11048259|NCT01294267|FG000|Participant Flow|Circulatory Support System|Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.
11048260|NCT01294267|OG000|Outcome|Circulatory Support System|"Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.~Circulatory Support System: Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects"
11048261|NCT01294267|EG000|Reported Event|Circulatory Support System|Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.
11048262|NCT01294306|BG000|Baseline|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
11048263|NCT01294306|BG001|Baseline|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
11048264|NCT01294306|BG002|Baseline|Total|Total of all reporting groups
11048265|NCT01294306|FG000|Participant Flow|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
11048266|NCT01294306|FG001|Participant Flow|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
11048267|NCT01294306|OG000|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
11048268|NCT01294306|OG001|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
11048269|NCT01294306|EG000|Reported Event|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
11048270|NCT01294306|EG001|Reported Event|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
11048271|NCT01294319|BG000|Baseline|Sedentary Young Adults, SMCP|Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone
11048272|NCT01294319|BG001|Baseline|Endurance-trained Young Athletes, SMCP|Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone
11348980|NCT04136145|OG000|Outcome|Belimumab 200 mg IV|Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.
11048273|NCT01294319|BG002|Baseline|Sedentary Young Adults, MSPC|Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone
11048274|NCT01294319|BG003|Baseline|Endurance-trained Young Athletes, MSPC|Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone
11048275|NCT01294319|BG004|Baseline|Sedentary Young Adults, CPSM|Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone
11048276|NCT01294319|BG005|Baseline|Endurance-trained Young Athletes, CPSM|Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone
11048277|NCT01294319|BG006|Baseline|Sedentary Young Adults,PCMS|Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
11048278|NCT01294319|BG007|Baseline|Endurance-trained Young Athletes,PCMS|Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
11048279|NCT01294319|BG008|Baseline|Total|Total of all reporting groups
11048280|NCT01294319|FG000|Participant Flow|Sedentary Young Adults, SMCP|Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone
11048281|NCT01294319|FG001|Participant Flow|Endurance-trained Young Athletes, SMCP|Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone
11048282|NCT01294319|FG002|Participant Flow|Sedentary Young Adults, MSPC|Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone
11048283|NCT01294319|FG003|Participant Flow|Endurance-trained Young Athletes, MSPC|Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone
11048284|NCT01294319|FG004|Participant Flow|Sedentary Young Adults, CPSM|Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone
11048285|NCT01294319|FG005|Participant Flow|Endurance-trained Young Athletes, CPSM|Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone
11048286|NCT01294319|FG006|Participant Flow|Sedentary Young Adults,PCMS|Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
11048287|NCT01294319|FG007|Participant Flow|Endurance-trained Young Athletes,PCMS|Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
11048288|NCT01294319|OG000|Outcome|Endurance-trained Young Athletes|"Endurance-trained Young Athletes group consists of 20 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone~Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone~Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone~Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
11048289|NCT01294319|OG001|Outcome|Sedentary Young Adults|"Sedentary young adults group consists of 19 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone~Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone~Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone~Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
11048290|NCT01294319|OG000|Outcome|Endurance-trained Young Athletes|"Endurance-trained young athletes group consists of 20 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone~Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone~Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone~Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
11048291|NCT01294319|EG000|Reported Event|Sedentary Young Adults|"Sedentary young adults group consists of 19 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
11048292|NCT01294319|EG001|Reported Event|Atheletes|"Endurance-trained Young Athletes group consists of 20 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
11149171|NCT01869075|EG001|Reported Event|AMI - Usual Care|Usual care as provided at the hospital
11149172|NCT01869075|EG002|Reported Event|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11149173|NCT01869075|EG003|Reported Event|MGS - Usual Care|Usual Care as provided at the hospital
11048293|NCT01294358|BG000|Baseline|All Participants|"All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h, 36 mg/m(2)/24h, 72 mg/m(2)/24h, 96 mg/m(2)/24h, and/or 115 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048294|NCT01294358|FG000|Participant Flow|18 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048295|NCT01294358|FG001|Participant Flow|36 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048296|NCT01294358|FG002|Participant Flow|72 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048297|NCT01294358|FG003|Participant Flow|96 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048298|NCT01294358|FG004|Participant Flow|115 mg/m(2)/24h.|"All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048299|NCT01294358|OG000|Outcome|18 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048300|NCT01294358|OG001|Outcome|36 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048301|NCT01294358|OG002|Outcome|72 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048302|NCT01294358|OG003|Outcome|96 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048303|NCT01294358|OG004|Outcome|115 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048304|NCT01294358|OG000|Outcome|Gemcitabine Dose Escalation|"All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h, 36 mg/m(2)/24h, 72 mg/m(2)/24h, 96 mg/m(2)/24h, and/or 115 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048305|NCT01294358|OG000|Outcome|18 mg/m(2)/24h,|"All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048306|NCT01294358|OG002|Outcome|72 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048307|NCT01294358|OG003|Outcome|96 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048308|NCT01294358|OG003|Outcome|96 mg/m(2)/24h.|"All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11348981|NCT04136145|OG000|Outcome|Belimumab 200 mg SC|Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
11048309|NCT01294358|EG000|Reported Event|18 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048310|NCT01294358|EG001|Reported Event|36 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048311|NCT01294358|EG002|Reported Event|72 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048312|NCT01294358|EG003|Reported Event|96 mg/m(2)/24h.|"All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048313|NCT01294358|EG004|Reported Event|115 mg/m(2)/24h|"All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h.~gemcitabine dose escalation~Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h."
11048314|NCT01294371|BG000|Baseline|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
11048315|NCT01294371|FG000|Participant Flow|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
11048316|NCT01294371|OG000|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
11348982|NCT04136145|OG001|Outcome|Belimumab 200 mg SC|Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
10846965|NCT00281528|BG000|Baseline|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
10846966|NCT00281528|BG001|Baseline|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
10846967|NCT00281528|BG002|Baseline|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
11048317|NCT01294371|OG000|Outcome|Overall|"Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was impossible - phytoestrogens with calcium products."
11048318|NCT01294371|OG001|Outcome|Plus Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and add-back therapy following local guidelines or therapeutic recommendations.
11048319|NCT01294371|OG002|Outcome|No Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
11048320|NCT01294371|EG000|Reported Event|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
11048321|NCT01294384|BG000|Baseline|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
10846968|NCT00281528|BG003|Baseline|Total|Total of all reporting groups
11048322|NCT01294384|BG001|Baseline|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
11048323|NCT01294384|BG002|Baseline|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
11048324|NCT01294384|BG003|Baseline|Total|Total of all reporting groups
11048325|NCT01294384|FG000|Participant Flow|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
11048326|NCT01294384|FG001|Participant Flow|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
11048327|NCT01294384|FG002|Participant Flow|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
11048328|NCT01294384|OG000|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
11048329|NCT01294384|OG001|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
11048330|NCT01294384|OG002|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
11048331|NCT01294384|EG000|Reported Event|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
11048332|NCT01294384|EG001|Reported Event|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
11048333|NCT01294384|EG002|Reported Event|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
11048334|NCT01294397|BG000|Baseline|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
11048335|NCT01294397|FG000|Participant Flow|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
11048336|NCT01294397|OG000|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
11048337|NCT01294397|EG000|Reported Event|Etanercept 50 mg Day - 28 - Day 7|Participants received etanercept 50 mg subcutaneously once weekly. Adverse events are reported from day -28 until day 7.
11048338|NCT01294397|EG001|Reported Event|Etanercept 50 mg + Denosumab 60 mg Day 8 - EOS|"Participants received etanercept 50 mg subcutaneously once weekly. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.~Adverse events are reported from day 8 to end of study (day 176)."
11048339|NCT01294397|EG002|Reported Event|All Subjects On-study|"Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.~Adverse events are reported from day -28 up to day 176."
11048340|NCT01294423|BG000|Baseline|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
11048341|NCT01294423|BG001|Baseline|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
11048342|NCT01294423|BG002|Baseline|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
11048343|NCT01294423|BG003|Baseline|Total|Total of all reporting groups
11048344|NCT01294423|FG000|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
11048345|NCT01294423|FG001|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
11048346|NCT01294423|FG002|Participant Flow|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
11048347|NCT01294423|OG000|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
11048348|NCT01294423|OG001|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
11348983|NCT04136145|EG000|Reported Event|Belimumab 200 mg IV|Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.
11048349|NCT01294423|OG002|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
11048350|NCT01294423|EG000|Reported Event|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
11048351|NCT01294423|EG001|Reported Event|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
11048352|NCT01294423|EG002|Reported Event|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
11048353|NCT01294436|BG000|Baseline|Monotherapy|Dapagliflozin 5/10 mg only
11048354|NCT01294436|BG001|Baseline|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
11048355|NCT01294436|BG002|Baseline|Total|Total of all reporting groups
11048356|NCT01294436|FG000|Participant Flow|Monotherapy|Dapagliflozin 5/10 mg only
11048357|NCT01294436|FG001|Participant Flow|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
11048358|NCT01294436|OG000|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
11048359|NCT01294436|OG001|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
11048360|NCT01294436|EG000|Reported Event|Monotherapy|Dapagliflozin 5/10 mg only
11048361|NCT01294436|EG001|Reported Event|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
11048362|NCT01294449|BG000|Baseline|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
11048363|NCT01294449|BG001|Baseline|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
11048364|NCT01294449|BG002|Baseline|Total|Total of all reporting groups
11048365|NCT01294449|FG000|Participant Flow|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
11048366|NCT01294449|FG001|Participant Flow|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
11048367|NCT01294449|OG000|Outcome|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
11048368|NCT01294449|OG001|Outcome|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
11048369|NCT01294449|EG000|Reported Event|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
11048370|NCT01294449|EG001|Reported Event|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
11048371|NCT01294462|BG000|Baseline|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
11048372|NCT01294462|BG001|Baseline|Clopidogrel|Clopidogrel 75mg od
11048373|NCT01294462|BG002|Baseline|Total|Total of all reporting groups
11048374|NCT01294462|FG000|Participant Flow|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
11048375|NCT01294462|FG001|Participant Flow|Clopidogrel|Clopidogrel 75mg od
11048376|NCT01294462|OG000|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
11048377|NCT01294462|OG001|Outcome|Clopidogrel|Clopidogrel 75mg od
11048378|NCT01294462|EG000|Reported Event|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
11048379|NCT01294462|EG001|Reported Event|Clopidogrel|Clopidogrel 75mg od
11048380|NCT01294514|BG000|Baseline|Healthy Volunteers|Healthy volunteers were studied
11048381|NCT01294514|FG000|Participant Flow|Respiration Rate in Healthy Volunteers|"Healthy volunteer participants were monitored for 30 minute period to collect respiratory rate information from non-invasive sensors.~Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide."
11048382|NCT01294514|OG000|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration Rate determined by novel plethysmographic analysis
11048383|NCT01294514|OG001|Outcome|Respiration Rate From Endtidal Carbon Dioxide|Respiration Rate determined by manual overscoring of capnography waveforms.
11048384|NCT01294514|OG002|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate determined by Transthoracic Impedance
11048385|NCT01294514|OG000|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
11048386|NCT01294514|OG000|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide.
11048387|NCT01294514|EG000|Reported Event|Healthy Volunteers|A selection of subjects from the general population from ages 18 - 50.
11048388|NCT01294553|BG000|Baseline|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
11048389|NCT01294553|FG000|Participant Flow|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to the appropriate dose of Avandamet tablet based on their current regimen (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg). Participants were not to have exceeded the maximum recommended daily dose of 8/2000. All participants were to have started the rosiglitazone component of Avandamet at the lowest recommended dose, and all dose increases should have been accompanied by careful monitoring for adverse events related to fluid retention.
11048390|NCT01294553|OG000|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
11048391|NCT01294553|OG000|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
11048392|NCT01294553|EG000|Reported Event|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
11048393|NCT01294579|BG000|Baseline|Ofatumumab and Bendamustine|1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
11048394|NCT01294579|FG000|Participant Flow|Ofatumumab and Bendamustine|1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
11048395|NCT01294579|OG000|Outcome|Ofatumumab and Bendamustine|1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
11048396|NCT01294579|EG000|Reported Event|Ofatumumab + Bendamustine|Ofatumumab + Bendamustine
11048397|NCT01294592|BG000|Baseline|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
11048398|NCT01294592|BG001|Baseline|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
11048399|NCT01294592|BG002|Baseline|Total|Total of all reporting groups
11048400|NCT01294592|FG000|Participant Flow|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
11048401|NCT01294592|FG001|Participant Flow|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
11048402|NCT01294592|OG000|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
11048403|NCT01294592|OG001|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
11048404|NCT01294592|OG001|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
11048405|NCT01294592|OG002|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
11048406|NCT01294592|EG000|Reported Event|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
11048407|NCT01294592|EG001|Reported Event|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
11048408|NCT01294592|EG002|Reported Event|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
11048409|NCT01294644|BG000|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11048410|NCT01294644|BG001|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
11226455|NCT02374671|EG000|Reported Event|VisAbility Micro Insert Implantation - Single Arm|For post-implant safety analysis, the Implantation-Non Randomized, Implantation-Randomized, and Deferred Implantation-Randomized arms were combined into (one) safety cohort (306 subjects + 26 subjects + 28 subjects, respectively), per protocol. All 360 implanted subjects that received the VisAbility Micro Insert implantation were followed for 24 months and were not analyzed separately. I.e. Subjects who participated in the randomized sub-study crossed over into a single (safety) arm at the time of implantation. For safety analysis and adverse event reporting, all implanted subjects were considered one cohort as there was no difference in treatment nor follow-up after VisAbility Micro Insert implantation.
11048411|NCT01294644|BG002|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11048412|NCT01294644|BG003|Baseline|Total|Total of all reporting groups
11048413|NCT01294644|FG000|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11048414|NCT01294644|FG001|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
11048415|NCT01294644|FG002|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11048416|NCT01294644|OG000|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11048417|NCT01294644|OG001|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
11048418|NCT01294644|OG002|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11048419|NCT01294644|EG000|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11048420|NCT01294644|EG001|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
11048421|NCT01294644|EG002|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11048422|NCT01294683|BG000|Baseline|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
11048423|NCT01294683|BG001|Baseline|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
11048424|NCT01294683|BG002|Baseline|Total|Total of all reporting groups
11048425|NCT01294683|FG000|Participant Flow|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
11048426|NCT01294683|FG001|Participant Flow|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
11048427|NCT01294683|OG000|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
11048428|NCT01294683|OG001|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
11048429|NCT01294683|OG000|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
11048430|NCT01294683|OG001|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
11048431|NCT01294683|OG002|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
11048432|NCT01294683|OG003|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
11048433|NCT01294683|EG000|Reported Event|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
11048434|NCT01294683|EG001|Reported Event|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
11048435|NCT01294683|EG002|Reported Event|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III
11226456|NCT02374918|BG000|Baseline|mTBI Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11048436|NCT01294683|EG003|Reported Event|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
11048437|NCT01294709|BG000|Baseline|All Enrolled Participants|All enrolled participants who recieved at least one dose of either telcagepant or placebo.
11226457|NCT02374918|BG001|Baseline|mTBI Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
10846969|NCT00281528|FG000|Participant Flow|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
11048438|NCT01294709|FG000|Participant Flow|Telcagepant Then Placebo|Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
11048439|NCT01294709|FG001|Participant Flow|Placebo Then Telcagepant|Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
11048440|NCT01294709|OG000|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
11048441|NCT01294709|OG001|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
11048442|NCT01294709|OG002|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
11048443|NCT01294709|OG000|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
11048444|NCT01294709|OG001|Outcome|Placebo|Participants who received single oral dose of placebo in Period 1 or 2 of crossover
11048445|NCT01294709|OG001|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
11048446|NCT01294709|EG000|Reported Event|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
11048447|NCT01294709|EG001|Reported Event|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
11048448|NCT01294709|EG002|Reported Event|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
11048449|NCT01294748|BG000|Baseline|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11048450|NCT01294748|BG001|Baseline|Endeavor DES|Active Comparator: Endeavor DES
11048451|NCT01294748|BG002|Baseline|Total|Total of all reporting groups
11048452|NCT01294748|FG000|Participant Flow|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11048453|NCT01294748|FG001|Participant Flow|Endeavor DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11048454|NCT01294748|OG000|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11048455|NCT01294748|OG001|Outcome|Endeavor DES|Active Comparator: Endeavor DES
11048456|NCT01294748|EG000|Reported Event|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
11048457|NCT01294748|EG001|Reported Event|Endeavor DES|Active Comparator: Endeavor DES
11048458|NCT01294787|BG000|Baseline|All Participants|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods. One participant was randomized but did not receive study drug.
11048459|NCT01294787|FG000|Participant Flow|QVA149 / Placebo / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
11048460|NCT01294787|FG001|Participant Flow|QVA149 / Tiotropium / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
11048461|NCT01294787|FG002|Participant Flow|Placebo / QVA149 / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
11048462|NCT01294787|FG003|Participant Flow|Placebo / Tiotropium / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
11048463|NCT01294787|FG004|Participant Flow|Tiotropium / QAV149 / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
11048464|NCT01294787|FG005|Participant Flow|Tiotropium / Placebo / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
11048465|NCT01294787|OG000|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
11048466|NCT01294787|OG001|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
11048467|NCT01294787|OG001|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
11048468|NCT01294787|OG002|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
11226458|NCT02374918|BG002|Baseline|HC Wavelength-1 Bright Light|"30 minutes of light exposure~HC wavelength-1 bright light: 30 minutes of light exposure"
11048469|NCT01294787|OG002|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
11048470|NCT01294787|OG000|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
11048471|NCT01294787|EG000|Reported Event|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
11048472|NCT01294787|EG001|Reported Event|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
11048473|NCT01294787|EG002|Reported Event|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
11048474|NCT01294800|BG000|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
11048475|NCT01294800|BG001|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048476|NCT01294800|BG002|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048477|NCT01294800|BG003|Baseline|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048478|NCT01294800|BG004|Baseline|Total|Total of all reporting groups
11048479|NCT01294800|FG000|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
11048480|NCT01294800|FG001|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048481|NCT01294800|FG002|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048482|NCT01294800|FG003|Participant Flow|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048483|NCT01294800|OG000|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048484|NCT01294800|OG001|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048485|NCT01294800|OG002|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048486|NCT01294800|OG003|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048487|NCT01294800|EG000|Reported Event|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048488|NCT01294800|EG001|Reported Event|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048489|NCT01294800|EG002|Reported Event|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11226459|NCT02374918|BG003|Baseline|HC Wavelength-2 Bright Light|"30 minutes of light exposure~HC wavelength-2 bright light: 30 minutes of light exposure"
11226460|NCT02374918|BG004|Baseline|Total|Total of all reporting groups
11048490|NCT01294800|EG003|Reported Event|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
11048491|NCT01294917|BG000|Baseline|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
11048492|NCT01294917|FG000|Participant Flow|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
11048493|NCT01294917|OG000|Outcome|AMO Investigational MPS|All subjects received the AMO Investigational MPS for one month for the care of their soft contact lenses.
11048494|NCT01294917|OG001|Outcome|Clear Care|All subjects received the Clear Care for one month for the care of their soft contact lenses.
11048495|NCT01294917|OG002|Outcome|OptiFree RepleniSH MPS|All subjects received the OptiFree RepleniSH MPS for one month for the care of their soft contact lenses.
11048496|NCT01294917|EG000|Reported Event|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
11048497|NCT01295034|BG000|Baseline|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
11048498|NCT01295034|BG001|Baseline|Tiered/Titrated Vitamin B Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
11048499|NCT01295034|BG002|Baseline|Total|Total of all reporting groups
11048500|NCT01295034|FG000|Participant Flow|Conventional Vitamin D Treatment|conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
11048501|NCT01295034|FG001|Participant Flow|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
11048502|NCT01295034|OG000|Outcome|Conventional Vitamin D Treatment|conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
11048503|NCT01295034|OG001|Outcome|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
11048504|NCT01295034|OG000|Outcome|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
11048505|NCT01295034|EG000|Reported Event|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
11048506|NCT01295034|EG001|Reported Event|Tiered/Titrated Vitamin B Dosing|Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
11048507|NCT01295112|BG000|Baseline|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
11048508|NCT01295112|BG001|Baseline|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
11048509|NCT01295112|BG002|Baseline|Total|Total of all reporting groups
11226461|NCT02374918|FG000|Participant Flow|mTBI Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
10846970|NCT00281528|FG001|Participant Flow|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
11048510|NCT01295112|FG000|Participant Flow|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
11048511|NCT01295112|FG001|Participant Flow|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
11048512|NCT01295112|OG000|Outcome|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
11048513|NCT01295112|OG001|Outcome|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
11048514|NCT01295112|EG000|Reported Event|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
11048515|NCT01295112|EG001|Reported Event|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
11048516|NCT01295216|BG000|Baseline|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
11048517|NCT01295216|BG001|Baseline|Control|Individuals who receive the usual primary health care
11048518|NCT01295216|BG002|Baseline|Total|Total of all reporting groups
11048519|NCT01295216|FG000|Participant Flow|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
11048520|NCT01295216|FG001|Participant Flow|Control|Individuals who receive the usual primary health care
11048521|NCT01295216|OG000|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
11048522|NCT01295216|OG001|Outcome|Control|Individuals who receive the usual primary health care
11048523|NCT01295216|EG000|Reported Event|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
11048524|NCT01295216|EG001|Reported Event|Control|Individuals who receive the usual primary health care
11048525|NCT01295281|BG000|Baseline|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
11048526|NCT01295281|BG001|Baseline|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
11048527|NCT01295281|BG002|Baseline|Total|Total of all reporting groups
11048528|NCT01295281|FG000|Participant Flow|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
11048529|NCT01295281|FG001|Participant Flow|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
11048530|NCT01295281|OG000|Outcome|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
11048531|NCT01295281|OG001|Outcome|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
11048532|NCT01295281|EG000|Reported Event|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
11048533|NCT01295281|EG001|Reported Event|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
11048534|NCT01295320|BG000|Baseline|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
11048535|NCT01295320|FG000|Participant Flow|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
11048536|NCT01295320|OG000|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
11048537|NCT01295320|EG000|Reported Event|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
11048538|NCT01295515|BG000|Baseline|Interferon Treatment|"Interferon treatment~Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b"
11048539|NCT01295515|FG000|Participant Flow|Interferon Treatment|"Interferon treatment~Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b"
11048540|NCT01295515|OG000|Outcome|Interferon Treatment|"Interferon treatment~Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b"
11048541|NCT01295515|EG000|Reported Event|Interferon Treatment|"Interferon treatment~Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b"
11048542|NCT01295580|BG000|Baseline|ARTZ|ARTZ: Hyaluronic acid (five 2.5 mL injections)
11048543|NCT01295580|BG001|Baseline|DUROLANE|DUROLANE: Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections)
11048544|NCT01295580|BG002|Baseline|Total|Total of all reporting groups
11048545|NCT01295580|FG000|Participant Flow|ARTZ|ARTZ: Hyaluronic acid (five 2.5 mL injections)
11048546|NCT01295580|FG001|Participant Flow|DUROLANE|DUROLANE: Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections)
11048547|NCT01295580|OG000|Outcome|ARTZ|ARTZ: Hyaluronic acid (five 2.5 mL injections)
11048548|NCT01295580|OG001|Outcome|DUROLANE|DUROLANE: Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections)
11048549|NCT01295580|EG000|Reported Event|ARTZ|ARTZ: Hyaluronic acid (five 2.5 mL injections)
11048550|NCT01295580|EG001|Reported Event|DUROLANE|DUROLANE: Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections)
11048551|NCT01295671|BG000|Baseline|Sugar-Sweetened Beverages|"Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048552|NCT01295671|BG001|Baseline|Artificially-Sweetened Beverages|"Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048553|NCT01295671|BG002|Baseline|Unsweetened Beverages|"Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048554|NCT01295671|BG003|Baseline|Total|Total of all reporting groups
11048555|NCT01295671|FG000|Participant Flow|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048556|NCT01295671|FG001|Participant Flow|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048557|NCT01295671|FG002|Participant Flow|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048558|NCT01295671|OG000|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048559|NCT01295671|OG001|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048560|NCT01295671|OG002|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048561|NCT01295671|EG000|Reported Event|Group 1|"Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048562|NCT01295671|EG001|Reported Event|Group 2|"Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048563|NCT01295671|EG002|Reported Event|Group 3|"Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
11048564|NCT01295710|BG000|Baseline|US-ATG-F|20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
11048565|NCT01295710|BG001|Baseline|Placebo|250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
11048566|NCT01295710|BG002|Baseline|Total|Total of all reporting groups
11048567|NCT01295710|FG000|Participant Flow|US-ATG-F|20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
11048568|NCT01295710|FG001|Participant Flow|Placebo|250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
11048569|NCT01295710|OG000|Outcome|US-ATG-F|20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
11048570|NCT01295710|OG001|Outcome|Placebo|250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
11048571|NCT01295710|EG000|Reported Event|US-ATG-F|20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
11048572|NCT01295710|EG001|Reported Event|Placebo|250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
11048573|NCT01295814|BG000|Baseline|Inactive Drug|inactive drug : placebo
11048574|NCT01295814|BG001|Baseline|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
11048575|NCT01295814|BG002|Baseline|Total|Total of all reporting groups
11048576|NCT01295814|FG000|Participant Flow|Inactive Drug|inactive drug : placebo
11048577|NCT01295814|FG001|Participant Flow|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
11048578|NCT01295814|OG000|Outcome|Inactive Drug|inactive drug : placebo
11048579|NCT01295814|OG001|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
11048580|NCT01295814|EG000|Reported Event|Inactive Drug|inactive drug : placebo
11048581|NCT01295814|EG001|Reported Event|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
11048582|NCT01295827|BG000|Baseline|Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A)|During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.
11048583|NCT01295827|BG001|Baseline|Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A)|During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.
11048584|NCT01295827|BG002|Baseline|Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1)|During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.
11048585|NCT01295827|BG003|Baseline|Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.
11048586|NCT01295827|BG004|Baseline|Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.
11048587|NCT01295827|BG005|Baseline|Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.
11048588|NCT01295827|BG006|Baseline|MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048589|NCT01295827|BG007|Baseline|MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048590|NCT01295827|BG008|Baseline|MEL: Pembrolizumab 10 mg/kg Q2W (Part B)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048591|NCT01295827|BG009|Baseline|NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048592|NCT01295827|BG010|Baseline|NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048593|NCT01295827|BG011|Baseline|NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048594|NCT01295827|BG012|Baseline|Total|Total of all reporting groups
11048595|NCT01295827|FG000|Participant Flow|Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A)|During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab intravenous (IV) infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg every 2 weeks (Q2W) starting with Cycle 2.
11048596|NCT01295827|FG001|Participant Flow|Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A)|During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.
11048597|NCT01295827|FG002|Participant Flow|Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1)|During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.
11226462|NCT02374918|FG001|Participant Flow|mTBI Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11226463|NCT02374918|FG002|Participant Flow|HC Wavelength-1 Bright Light|"30 minutes of light exposure~HC wavelength-1 bright light: 30 minutes of light exposure"
11226464|NCT02374918|FG003|Participant Flow|HC Wavelength-2 Bright Light|"30 minutes of light exposure~HC wavelength-2 bright light: 30 minutes of light exposure"
11226465|NCT02374918|OG000|Outcome|mTBI Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11226466|NCT02374918|OG001|Outcome|mTBI Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11226467|NCT02374918|EG000|Reported Event|mTBI Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11226468|NCT02374918|EG001|Reported Event|mTBI Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
11226469|NCT02374918|EG002|Reported Event|HC Wavelength-1 Bright Light|"30 minutes of light exposure~HC wavelength-1 bright light: 30 minutes of light exposure"
10846971|NCT00281528|FG002|Participant Flow|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
10846972|NCT00281528|OG000|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
11048598|NCT01295827|FG003|Participant Flow|Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.
11048599|NCT01295827|FG004|Participant Flow|Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.
11048600|NCT01295827|FG005|Participant Flow|Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.
11048601|NCT01295827|FG006|Participant Flow|MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048602|NCT01295827|FG007|Participant Flow|MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11226470|NCT02374918|EG003|Reported Event|HC Wavelength-2 Bright Light|"30 minutes of light exposure~HC wavelength-2 bright light: 30 minutes of light exposure"
11226471|NCT02374957|BG000|Baseline|Cilostazol|"Administer Cilostazol100 mg twice daily for 90 days.~Cilostazol: 100 mg twice daily for 90 days"
11226472|NCT02374957|BG001|Baseline|Control|No Cilostazol
11226473|NCT02374957|BG002|Baseline|Total|Total of all reporting groups
11226474|NCT02374957|FG000|Participant Flow|Cilostazol|"Administer Cilostazol100 mg twice daily for 90 days.~Cilostazol: 100 mg twice daily for 90 days"
11226475|NCT02374957|FG001|Participant Flow|Control|No Cilostazol
11226476|NCT02374957|OG000|Outcome|Cilostazol|"Administer Cilostazol100 mg twice daily for 90 days.~Cilostazol: 100 mg twice daily for 90 days"
11226477|NCT02374957|OG001|Outcome|Control|No Cilostazol
11226478|NCT02374957|EG000|Reported Event|Cilostazol|"Administer Cilostazol100 mg twice daily for 90 days.~Cilostazol: 100 mg twice daily for 90 days"
11226479|NCT02374957|EG001|Reported Event|Control|No Cilostazol
11226480|NCT02375347|BG000|Baseline|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
11048603|NCT01295827|FG008|Participant Flow|MEL: Pembrolizumab 10 mg/kg Q2W (Part B)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048604|NCT01295827|FG009|Participant Flow|NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048605|NCT01295827|FG010|Participant Flow|NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048606|NCT01295827|FG011|Participant Flow|NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048607|NCT01295827|FG012|Participant Flow|NSCLC: Pembrolizumab 2 mg/kg Q3W (Part E-Not Enrolled)|Participants were to receive pembrolizumab IV at a dose of 2 mg/kg Q3W. No participants were enrolled in this arm.
11048608|NCT01295827|FG013|Participant Flow|NSCLC: Pembrolizumab 5 mg/kg Q3W (Part E-Not Enrolled)|Participants were to receive pembrolizumab IV at a dose of 5 mg/kg Q3W. No participants were enrolled in this arm.
11048609|NCT01295827|FG014|Participant Flow|NSCLC: Pembrolizumab 10 mg/kg Q3W (Part E-Not Enrolled)|Participants were to receive pembrolizumab IV at a dose of 10 mg/kg Q3W. No participants were enrolled in this arm.
11048610|NCT01295827|OG000|Outcome|Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A)|During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.
11048611|NCT01295827|OG001|Outcome|Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A)|During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.
11048612|NCT01295827|OG002|Outcome|Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1)|During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.
11048613|NCT01295827|OG003|Outcome|Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.
11048614|NCT01295827|OG004|Outcome|Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.
11048615|NCT01295827|OG005|Outcome|Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.
11048616|NCT01295827|OG006|Outcome|MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048617|NCT01295827|OG007|Outcome|MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048618|NCT01295827|OG008|Outcome|MEL: Pembrolizumab 10 mg/kg Q2W (Part B)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048619|NCT01295827|OG009|Outcome|NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048620|NCT01295827|OG010|Outcome|NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048621|NCT01295827|OG011|Outcome|NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048622|NCT01295827|OG000|Outcome|MEL: Pembrolizumab 2 mg/kg Q3W (Part B)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W.
11226481|NCT02375347|FG000|Participant Flow|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
11226482|NCT02375347|OG000|Outcome|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
11048623|NCT01295827|OG001|Outcome|MEL: Pembrolizumab 10 mg/kg Q3W (Part B)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W.
11048624|NCT01295827|OG002|Outcome|MEL: Pembrolizumab 10 mg/kg Q2W (Part B)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W.
11048625|NCT01295827|OG003|Outcome|MEL: Pembrolizumab 2 mg/kg Q3W (Part D)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W.
11048626|NCT01295827|OG004|Outcome|MEL: Pembrolizumab 10 mg/kg Q3W (Part D)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W.
11048627|NCT01295827|OG000|Outcome|NSCLC: Pembrolizumab 10 mg/kg Q3W (Part C)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W.
11048628|NCT01295827|OG001|Outcome|NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W.
11048629|NCT01295827|OG002|Outcome|NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W.
11048630|NCT01295827|OG003|Outcome|NSCLC: Pembrolizumab 10 mg/kg Q3W (Part F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W.
11048631|NCT01295827|OG000|Outcome|MEL (Parts B+D): Ipi-Exposed PD-L1 Positive|Ipi-Exposed melanoma participants that received IV pembrolizumab on study and whose tumors were positive for PD-L1 (TPS ≥1%)
11048632|NCT01295827|OG001|Outcome|MEL (Parts B+D): Ipi-Exposed PD-L1 Negative|Ipi-Exposed melanoma participants that received IV pembrolizumab on study and whose tumors were negative for PD-L1 (TPS <1%)
11048633|NCT01295827|OG002|Outcome|MEL (Parts B+D): Ipi-Exposed PD-L1 Unknown|Ipi-Exposed melanoma participants that received IV pembrolizumab on study and whose tumors had an unknown PD-L1 status.
11048634|NCT01295827|OG003|Outcome|MEL (Parts B+D): All Ipi-Exposed Participants|All Ipi-Exposed melanoma participants that received IV pembrolizumab on study.
11048635|NCT01295827|OG004|Outcome|MEL (Parts B+D): Ipi-Naive PD-L1 Positive|Ipi-Naive melanoma participants that received IV pembrolizumab on study and whose tumors were positive for PD-L1 (TPS ≥1%).
11048636|NCT01295827|OG005|Outcome|MEL (Parts B+D): Ipi- Naive PD-L1 Negative|Ipi-Naive melanoma participants that received IV pembrolizumab on study and whose tumors were negative for PD-L1 (TPS <1%).
11048637|NCT01295827|OG006|Outcome|MEL (Parts B+D): Ipi- Naive PD-L1 Unknown|Ipi-Naive melanoma participants that received IV pembrolizumab on study and whose tumors had an unknown PD-L1 status.
11048638|NCT01295827|OG007|Outcome|MEL (Parts B+D): All Ipi- Naive Participants|All Ipi-Naive melanoma participants that received IV pembrolizumab on study.
10846973|NCT00281528|OG001|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
11048639|NCT01295827|OG000|Outcome|NSCLC (Parts C+F): TRT-Naïve TPS ≥50%|Prior treatment (TRT)-naïve NSCLC participants that received IV pembrolizumab on study and whose tumors were strongly positive for PD-L1 (TPS ≥50%).
11048640|NCT01295827|OG001|Outcome|NSCLC (Parts C+F): TRT-Naïve TPS = 1-49%|Prior TRT-naïve NSCLC participants that received IV pembrolizumab on study and whose tumors were weakly positive for PD-L1 (TPS 1-49%).
11048641|NCT01295827|OG002|Outcome|NSCLC (Parts C+F): TRT-Naïve TPS <1%|Prior TRT-naïve NSCLC participants that received IV pembrolizumab on study and whose tumors were negative for PD-L1 (TPS <1%).
11048642|NCT01295827|OG003|Outcome|NSCLC (Parts C+F): TRT-Naïve TPS Unknown|Prior TRT-naïve NSCLC participants that received IV pembrolizumab on study and whose tumors had an unknown PD-L1 status.
11048643|NCT01295827|OG004|Outcome|NSCLC (Parts C+F): All TRT-Naïve Participants|All prior TRT-naïve NSCLC participants that received IV pembrolizumab on study.
11048644|NCT01295827|OG005|Outcome|NSCLC (Parts C+F): Previously Treated TPS ≥50%|Previously-treated NSCLC participants that received IV pembrolizumab on study and whose tumors were strongly positive for PD-L1 (TPS ≥50%).
11048645|NCT01295827|OG006|Outcome|NSCLC (Parts C+F): Previously Treated TPS = 1-49%|Previously-treated NSCLC participants that received IV pembrolizumab on study and whose tumors were weakly positive for PD-L1 (TPS 1-49%).
11048646|NCT01295827|OG007|Outcome|NSCLC (Parts C+F): Previously Treated TPS <1%|Previously-treated NSCLC participants that received IV pembrolizumab on study and whose tumors were negative for PD-L1 (TPS <1%).
11048647|NCT01295827|OG008|Outcome|NSCLC (Parts C+F): Previously Treated TPS Unknown|Previously-treated NSCLC participants that received IV pembrolizumab on study and whose tumors had an unknown PD-L1 status.
11048648|NCT01295827|OG009|Outcome|NSCLC (Parts C+F): All Previously Treated Participants|All Previously-treated NSCLC participants that received IV pembrolizumab on study.
11048649|NCT01295827|EG000|Reported Event|Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A)|During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.
11048650|NCT01295827|EG001|Reported Event|Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A)|During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.
11048651|NCT01295827|EG002|Reported Event|Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1)|During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.
11048652|NCT01295827|EG003|Reported Event|Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.
11048653|NCT01295827|EG004|Reported Event|Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.
11048654|NCT01295827|EG005|Reported Event|Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2)|During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.
11048655|NCT01295827|EG006|Reported Event|MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048656|NCT01295827|EG007|Reported Event|MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048657|NCT01295827|EG008|Reported Event|MEL: Pembrolizumab 10 mg/kg Q2W (Part B)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048658|NCT01295827|EG009|Reported Event|NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F)|Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048659|NCT01295827|EG010|Reported Event|NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048660|NCT01295827|EG011|Reported Event|NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F)|Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
11048661|NCT01295840|BG000|Baseline|No Arms|All patient have a Quartet LV lead. No arms.
11048662|NCT01295840|FG000|Participant Flow|No Arms|All patient have a Quartet Left Ventricular (LV) lead. No arms.
11048663|NCT01295840|OG000|Outcome|No Arms|All patient have a Quartet LV lead. No arms.
11048664|NCT01295840|OG000|Outcome|No Arms|All patient have a Quartet LV lead. No arms
11048665|NCT01295840|OG000|Outcome|Quartet LV Lead|All patient have a Quartet LV lead. No arms
11048666|NCT01295840|EG000|Reported Event|No Arms|All patient have a Quartet LV lead. No arms
11048667|NCT01295879|BG000|Baseline|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
11048668|NCT01295879|FG000|Participant Flow|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
11048669|NCT01295879|OG000|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
11048670|NCT01295879|EG000|Reported Event|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
11048671|NCT01295905|BG000|Baseline|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
11048672|NCT01295905|BG001|Baseline|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
11048673|NCT01295905|BG002|Baseline|Total|Total of all reporting groups
11048674|NCT01295905|FG000|Participant Flow|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
11048675|NCT01295905|FG001|Participant Flow|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
11048676|NCT01295905|OG000|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
11048677|NCT01295905|OG001|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
11048678|NCT01295905|EG000|Reported Event|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
11048679|NCT01295905|EG001|Reported Event|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
11066728|NCT01393743|FG002|Participant Flow|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator's discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
11066729|NCT01393743|OG000|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
11066730|NCT01393743|OG001|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
11066731|NCT01393743|OG000|Outcome|Perampanel Extension Phase|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who received placebo in the Core Study were started on blinded oral perampanel (2 mg/day) and were up-titrated weekly in 2-mg increments to the optimal dose per investigator's discretion, up to 12 mg/day perampanel maximum. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
11048680|NCT01296035|BG000|Baseline|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
11048681|NCT01296035|FG000|Participant Flow|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
11048682|NCT01296035|OG000|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
11048683|NCT01296035|EG000|Reported Event|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
11048684|NCT01296152|BG000|Baseline|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~Depo-medroxyprogesterone Acetate"
11048685|NCT01296152|FG000|Participant Flow|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~Depo-medroxyprogesterone Acetate"
11048686|NCT01296152|OG000|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
11048687|NCT01296152|EG000|Reported Event|Arm A|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
11048688|NCT01296191|BG000|Baseline|VIGAMOX|Subjects undergoing cataract surgery, randomized to the VIGAMOX group
11048689|NCT01296191|BG001|Baseline|Besivance|Subjects scheduled for cataract surgery, randomized to the Besivance group
11048690|NCT01296191|BG002|Baseline|Total|Total of all reporting groups
11048691|NCT01296191|FG000|Participant Flow|VIGAMOX|Subjects undergoing cataract surgery, randomized to the VIGAMOX group
11048692|NCT01296191|FG001|Participant Flow|Besivance|Subjects scheduled for cataract surgery, randomized to the Besivance group
11048693|NCT01296191|OG000|Outcome|VIGAMOX|Subjects undergoing cataract surgery, randomized to the VIGAMOX group
11048694|NCT01296191|OG001|Outcome|Besivance|Subjects scheduled for cataract surgery, randomized to the Besivance group
11048695|NCT01296191|EG000|Reported Event|VIGAMOX|Subjects undergoing cataract surgery, randomized to the VIGAMOX group
11048696|NCT01296191|EG001|Reported Event|Besivance|Subjects scheduled for cataract surgery, randomized to the Besivance group
11048697|NCT01296347|BG000|Baseline|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
11048698|NCT01296347|BG001|Baseline|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
11048699|NCT01296347|BG002|Baseline|Total|Total of all reporting groups
11048700|NCT01296347|FG000|Participant Flow|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
11048701|NCT01296347|FG001|Participant Flow|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
11048702|NCT01296347|OG000|Outcome|Saline|Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the start of the operation and continued for 96 hours.
11048703|NCT01296347|OG001|Outcome|Ketamine|Patients received intravenous ketamine, starting 10 minutes prior to surgery and continued for 96 hours
11048704|NCT01296347|OG000|Outcome|Saline|Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the start of the operation and continue for 96 hours.
11048705|NCT01296347|OG001|Outcome|Ketamine|Patients received intravenous ketamine, started 10 minutes prior to surgery and continued for 96 hours
11048706|NCT01296347|OG000|Outcome|Saline|Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the started of the operation and continue for 96 hours.
11048707|NCT01296347|EG000|Reported Event|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
11048708|NCT01296347|EG001|Reported Event|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
11048709|NCT01296360|BG000|Baseline|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
11048710|NCT01296360|BG001|Baseline|Non-Booster Group|No treatment in study IC51-325
11048711|NCT01296360|BG002|Baseline|Total|Total of all reporting groups
11048712|NCT01296360|FG000|Participant Flow|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
11048713|NCT01296360|FG001|Participant Flow|Non-Booster Group|No treatment in study IC51-325
11048714|NCT01296360|OG000|Outcome|>14 Months to <2 Years|booster vaccination: IXIARO 0.25 ml i.m. (milliliter, intramuscular)
11048715|NCT01296360|OG001|Outcome|>3 Years - <18 Years|booster vaccination: IXIARO 0.5 ml i.m (milliliter, intramuscular)
11048716|NCT01296360|EG000|Reported Event|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
11048717|NCT01296360|EG001|Reported Event|Non-Booster Group|No treatment in study IC51-325
11048718|NCT01296412|BG000|Baseline|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
11048719|NCT01296412|BG001|Baseline|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
11048720|NCT01296412|BG002|Baseline|Total|Total of all reporting groups
11048721|NCT01296412|FG000|Participant Flow|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
11048722|NCT01296412|FG001|Participant Flow|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
11048723|NCT01296412|OG000|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
11048724|NCT01296412|OG001|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
11048725|NCT01296412|EG000|Reported Event|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
11048726|NCT01296412|EG001|Reported Event|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
11048727|NCT01296542|BG000|Baseline|VIGAMOX|Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
11048728|NCT01296542|BG001|Baseline|Besivance|Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
11048729|NCT01296542|BG002|Baseline|Total|Total of all reporting groups
11048730|NCT01296542|FG000|Participant Flow|VIGAMOX|Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
11048731|NCT01296542|FG001|Participant Flow|Besivance|Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
11048732|NCT01296542|OG000|Outcome|VIGAMOX|Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
11048733|NCT01296542|OG001|Outcome|Besivance|Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
11048734|NCT01296542|EG000|Reported Event|VIGAMOX|Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
11048735|NCT01296542|EG001|Reported Event|Besivance|Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
11048736|NCT01296568|BG000|Baseline|Entire Study Population|"In the [^14C]LY2603618 Single Dose and Washout Phase (first phase), participants received a single 250 milligram (mg) dose of LY2603618 containing [^14C]LY2603618, administered as a 1-hour intravenous infusion. Participants then completed a minimum 7-day washout period.~In the Continued Access Phase (second phase), participants received additional doses of LY2603618 in combination with gemcitabine as follows:~• Gemcitabine 1000 milligrams per square meter (mg/m^2) administered as an intravenous infusion on Days 1, 8, and 15 with 230 mg LY2603618 administered intravenously on Days 2, 9 and 16 of a 28-day cycle.~Participants were allowed to continue to receive the combination therapy until fulfilling 1 of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11048737|NCT01296568|FG000|Participant Flow|Entire Study Population|"In the [^14C]LY2603618 Single Dose and Washout Phase (first phase), participants received a single 250 milligram (mg) dose of LY2603618 containing [^14C]LY2603618, administered as a 1-hour intravenous infusion. Participants then completed a minimum 7-day washout period.~In the Continued Access Phase (second phase), participants received additional doses of LY2603618 in combination with gemcitabine as follows:~• Gemcitabine 1000 milligrams per square meter (mg/m^2) administered as an intravenous infusion on Days 1, 8, and 15 with 230 mg LY2603618 administered intravenously on Days 2, 9 and 16 of a 28-day cycle.~Participants were allowed to continue to receive the combination therapy until fulfilling 1 of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11048738|NCT01296568|OG000|Outcome|[^14C]LY2603618|Participants in the first phase of the study received a single 250 milligram (mg) dose of LY2603618 containing [^14C]LY2603618, administered as a 1-hour intravenous infusion. Participants then completed a minimum 7-day washout period.
11048739|NCT01296568|OG000|Outcome|Entire Study Population|"In the [^14C]LY2603618 Single Dose and Washout Phase (first phase), participants received a single 250 milligram (mg) dose of LY2603618 containing [^14C]LY2603618, administered as a 1-hour intravenous infusion. Participants then completed a minimum 7-day washout period.~In the Continued Access Phase (second phase), participants received additional doses of LY2603618 in combination with gemcitabine as follows:~• Gemcitabine 1000 milligrams per square meter (mg/m^2) administered as an intravenous infusion on Days 1, 8, and 15 with 230 mg LY2603618 administered intravenously on Days 2, 9 and 16 of a 28-day cycle.~Participants were allowed to continue to receive the combination therapy until fulfilling 1 of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
10846974|NCT00281528|OG002|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
11048740|NCT01296568|EG000|Reported Event|[^14C]LY2603618|Adverse events reported during the first phase of the study. Participants received a single 250 milligram (mg) intravenous dose of LY2603618 containing [^14C]LY2603618 and then completed a minimum 7-day washout period.
11149174|NCT01869075|EG004|Reported Event|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
11048741|NCT01296568|EG001|Reported Event|LY2603618 + Gemcitabine|Adverse events reported during the second phase of the study. After completing the first phase [a single 250 milligram (mg) intravenous dose of LY2603618 containing [^14C]LY2603618 followed by a minimum 7-day washout period], participants received Gemcitabine 1000 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8, and 15 with 230 mg LY2603618 administered intravenously on Days 2, 9 and 16 of a 28-day cycle until unacceptable toxicity or disease progression.
11048742|NCT01296646|BG000|Baseline|Placebo|Placebo taken once daily.
11048743|NCT01296646|BG001|Baseline|Naltrexone|50 mg of naltrexone orally daily.
11048744|NCT01296646|BG002|Baseline|Total|Total of all reporting groups
11048745|NCT01296646|FG000|Participant Flow|Placebo|Placebo taken once daily.
11048746|NCT01296646|FG001|Participant Flow|Naltrexone|50 mg of naltrexone orally daily.
11048747|NCT01296646|OG000|Outcome|Placebo|Placebo taken once daily.
11048748|NCT01296646|OG001|Outcome|Naltrexone|50 mg of naltrexone orally daily.
11048749|NCT01296646|EG000|Reported Event|Placebo|Placebo taken once daily.
11048750|NCT01296646|EG001|Reported Event|Naltrexone|50 mg of naltrexone orally daily.
11048751|NCT01296672|BG000|Baseline|Finasteride|"Finasteride 5mg tablets every day by mouth for 3 months~Finasteride: Finasteride 5mg every day by mouth for 3 months"
11048752|NCT01296672|BG001|Baseline|Placebo|"Placebo 5mg tablet every day by mouth for 3 months~Placebo: Placebo every day by mouth for 3 months"
11048753|NCT01296672|BG002|Baseline|Total|Total of all reporting groups
11048754|NCT01296672|FG000|Participant Flow|Finasteride|Finasteride 5mg every day by mouth for 3 months
11048755|NCT01296672|FG001|Participant Flow|Placebo|Placebo every day by mouth for 3 months
11048756|NCT01296672|OG000|Outcome|Finasteride|PSA Ratio AUC
11048757|NCT01296672|OG001|Outcome|Placebo|PSA Ratio AUC
11048758|NCT01296672|OG000|Outcome|Finasteride|Finasteride 5mg every day by mouth for 3 months
11048759|NCT01296672|OG001|Outcome|Placebo|Placebo every day by mouth for 3 months
11048760|NCT01296672|EG000|Reported Event|Finasteride|Finasteride 5mg every day by mouth for 3 months
11048761|NCT01296672|EG001|Reported Event|Placebo|Placebo every day by mouth for 3 months
11048762|NCT01296698|BG000|Baseline|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
11048763|NCT01296698|BG001|Baseline|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
11048764|NCT01296698|BG002|Baseline|Total|Total of all reporting groups
11048765|NCT01296698|FG000|Participant Flow|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
11048766|NCT01296698|FG001|Participant Flow|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
11048767|NCT01296698|OG000|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
11048768|NCT01296698|OG001|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
11048769|NCT01296698|EG000|Reported Event|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
11048770|NCT01296698|EG001|Reported Event|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
11048771|NCT01296763|BG000|Baseline|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
11048772|NCT01296763|BG001|Baseline|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
11048773|NCT01296763|BG002|Baseline|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
11048774|NCT01296763|BG003|Baseline|Total|Total of all reporting groups
11048775|NCT01296763|FG000|Participant Flow|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
11048776|NCT01296763|FG001|Participant Flow|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
11048777|NCT01296763|FG002|Participant Flow|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
11048778|NCT01296763|OG000|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
11048779|NCT01296763|OG001|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
11048780|NCT01296763|OG002|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
11048781|NCT01296763|EG000|Reported Event|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
11048782|NCT01296763|EG001|Reported Event|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
11048783|NCT01296763|EG002|Reported Event|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
11048784|NCT01296815|BG000|Baseline|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
11048785|NCT01296815|BG001|Baseline|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
11048786|NCT01296815|BG002|Baseline|Total|Total of all reporting groups
11048787|NCT01296815|FG000|Participant Flow|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
11048788|NCT01296815|FG001|Participant Flow|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
11048789|NCT01296815|OG000|Outcome|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
11048790|NCT01296815|OG001|Outcome|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
11048791|NCT01296815|EG000|Reported Event|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
11048792|NCT01296815|EG001|Reported Event|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
11048793|NCT01296841|BG000|Baseline|Standard Encounter|"Standard in-house clinical visit between patient and physician."
11048794|NCT01296841|BG001|Baseline|Telemedicine Encounter|Remote clinical appointment between patient and physician.
11048795|NCT01296841|BG002|Baseline|Total|Total of all reporting groups
11048796|NCT01296841|FG000|Participant Flow|Standard Encounter|"Standard in-house clinical visit between patient and physician."
11048797|NCT01296841|FG001|Participant Flow|Telemedicine Encounter|Remote clinical appointment between patient and physician.
11048798|NCT01296841|OG000|Outcome|Telemedicine|clinic experience (mean ± SD, 1 excellent, 5 poor)
11048799|NCT01296841|OG001|Outcome|Standard|clinic experience (mean±SD)
11048800|NCT01296841|OG000|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
11048801|NCT01296841|OG001|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
11048802|NCT01296841|EG000|Reported Event|Standard Encounter|"Standard in-house clinical visit between patient and physician."
11048803|NCT01296841|EG001|Reported Event|Telemedicine Encounter|Remote clinical appointment between patient and physician.
11048804|NCT01296932|BG000|Baseline|BI 836826 1 Milligram|Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
11048805|NCT01296932|BG001|Baseline|BI 836826 3 Milligram|Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
11048806|NCT01296932|BG002|Baseline|BI 836826 9 Milligram|Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
11348984|NCT04136145|EG001|Reported Event|Belimumab 200 mg SC|Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
11048807|NCT01296932|BG003|Baseline|BI 836826 25 Milligram|Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048808|NCT01296932|BG004|Baseline|BI 836826 50 Milligram|Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048809|NCT01296932|BG005|Baseline|BI 836826 100 Milligram|Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048810|NCT01296932|BG006|Baseline|BI 836826 200 Milligram|Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048811|NCT01296932|BG007|Baseline|BI 836826 400 Milligram|Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048812|NCT01296932|BG008|Baseline|BI 836826 800 Milligram|Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048813|NCT01296932|BG009|Baseline|Total|Total of all reporting groups
11048814|NCT01296932|FG000|Participant Flow|BI 836826 1 Milligram|Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
11048815|NCT01296932|FG001|Participant Flow|BI 836826 3 Milligram|Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
11048816|NCT01296932|FG002|Participant Flow|BI 836826 9 Milligram|Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
11048817|NCT01296932|FG003|Participant Flow|BI 836826 25 Milligram|Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048818|NCT01296932|FG004|Participant Flow|BI 836826 50 Milligram|Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048819|NCT01296932|FG005|Participant Flow|BI 836826 100 Milligram|Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048820|NCT01296932|FG006|Participant Flow|BI 836826 200 Milligram|Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048821|NCT01296932|FG007|Participant Flow|BI 836826 400 Milligram|Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048822|NCT01296932|FG008|Participant Flow|BI 836826 800 Milligram|Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048823|NCT01296932|OG000|Outcome|BI 836826 1 Milligram|Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
11048824|NCT01296932|OG001|Outcome|BI 836826 3 Milligram|Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
11048825|NCT01296932|OG002|Outcome|BI 836826 9 Milligram|Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
11149175|NCT01869075|EG005|Reported Event|HFS - Usual Care|Usual Care as provided at the hospital
11048826|NCT01296932|OG003|Outcome|BI 836826 25 Milligram|Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048827|NCT01296932|OG004|Outcome|BI 836826 50 Milligram|Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048828|NCT01296932|OG005|Outcome|BI 836826 100 Milligram|Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048829|NCT01296932|OG006|Outcome|BI 836826 200 Milligram|Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048830|NCT01296932|OG007|Outcome|BI 836826 400 Milligram|Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048831|NCT01296932|OG008|Outcome|BI 836826 800 Milligram|Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048832|NCT01296932|OG000|Outcome|BI 836826|Patients were administered BI 836826 solution for infusion after dilution intravenously as one or two doses within the first cycle followed by a single doses within all following 14-day cycles in the higher dose groups (>9 milligram BI 836826).
11048833|NCT01296932|EG000|Reported Event|BI 836826 1 Milligram|Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
11048834|NCT01296932|EG001|Reported Event|BI 836826 3 Milligram|Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
11048835|NCT01296932|EG002|Reported Event|BI 836826 9 Milligram|Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
11048836|NCT01296932|EG003|Reported Event|BI 836826 25 Milligram|Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048837|NCT01296932|EG004|Reported Event|BI 836826 50 Milligram|Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048838|NCT01296932|EG005|Reported Event|BI 836826 100 Milligram|Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048839|NCT01296932|EG006|Reported Event|BI 836826 200 Milligram|Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048840|NCT01296932|EG007|Reported Event|BI 836826 400 Milligram|Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048841|NCT01296932|EG008|Reported Event|BI 836826 800 Milligram|Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
11048842|NCT01297062|BG000|Baseline|Placebo-Exenatide-Moxifloxacin Sequence|Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III
11048843|NCT01297062|BG001|Baseline|Exenatide-Moxifloxacin-Placebo Sequence|Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III
11048844|NCT01297062|BG002|Baseline|Moxifloxacin-Placebo-Exenatide Sequence|Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III
11048845|NCT01297062|BG003|Baseline|Moxifloxacin-Exenatide-Placebo Sequence|Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III
11048846|NCT01297062|BG004|Baseline|Placebo-Moxifloxacin-Exenatiden Sequence|Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III
11048847|NCT01297062|BG005|Baseline|Exenatide-Placebo-Moxifloxacin Sequence|Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III
11048848|NCT01297062|BG006|Baseline|Total|Total of all reporting groups
11048849|NCT01297062|FG000|Participant Flow|Placebo-Exenatide-Moxifloxacin Sequence|"Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III;~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
11048850|NCT01297062|FG001|Participant Flow|Exenatide-Moxifloxacin-Placebo Sequence|"Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
11149176|NCT01869192|BG000|Baseline|Arm A|"Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment~Epirubicin: Epirubicin 90 mg/m2 d1 q3w~Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w~Radiation Therapy: Standard dosing, fields depending on clinical findings"
11048851|NCT01297062|FG002|Participant Flow|Moxifloxacin-Placebo-Exenatide Sequence|"Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
11048852|NCT01297062|FG003|Participant Flow|Moxifloxacin-Exenatide-Placebo Sequence|"Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
11048853|NCT01297062|FG004|Participant Flow|Placebo-Moxifloxacin-Exenatiden Sequence|"Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
11048854|NCT01297062|FG005|Participant Flow|Exenatide-Placebo-Moxifloxacin Sequence|"Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
11048855|NCT01297062|FG006|Participant Flow|Non-Randomized|Not Randomized
11048856|NCT01297062|OG000|Outcome|Exenatide|Exenatide
11048857|NCT01297062|OG001|Outcome|Placebo|Placebo Comparator
11048858|NCT01297062|OG000|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
11048859|NCT01297062|EG000|Reported Event|Exenatide|Exenatide
11048860|NCT01297062|EG001|Reported Event|Placebo|Placebo Comparator
11048861|NCT01297062|EG002|Reported Event|Moxifloxacin|Moxifloxacin with placebo infusion
11048862|NCT01297244|BG000|Baseline|Clear Cell RCC|Subjects received 1.5 mg tivozanib orally once daily beginning on Cycle 1 Day 1 for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks of treatment. Cycles are repeated every 4 weeks.
11048863|NCT01297244|BG001|Baseline|Non-Clear Cell RCC|Subjects received 1.5 mg tivozanib orally once daily beginning on Cycle 1 Day 1 for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks of treatment. Cycles are repeated every 4 weeks.
11048864|NCT01297244|BG002|Baseline|Total|Total of all reporting groups
11048865|NCT01297244|FG000|Participant Flow|Clear Cell RCC|Subjects received 1.5 mg tivozanib orally once daily beginning on Cycle 1 Day 1 for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks of treatment. Cycles are repeated every 4 weeks.
11048866|NCT01297244|FG001|Participant Flow|Non-Clear Cell RCC|Subjects received 1.5 mg tivozanib orally once daily beginning on Cycle 1 Day 1 for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks of treatment. Cycles are repeated every 4 weeks.
11048867|NCT01297244|OG000|Outcome|Tivozanib|"Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.~Tivozanib: Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks."
11048868|NCT01297244|OG000|Outcome|Clear Cell RCC|Subjects received 1.5 mg tivozanib orally once daily beginning on Cycle 1 Day 1 for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks of treatment. Cycles are repeated every 4 weeks.
11048869|NCT01297244|OG001|Outcome|Non-Clear Cell RCC|Subjects received 1.5 mg tivozanib orally once daily beginning on Cycle 1 Day 1 for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks of treatment. Cycles are repeated every 4 weeks.
11048870|NCT01297244|EG000|Reported Event|Clear Cell RCC|Subjects received 1.5 mg tivozanib orally once daily beginning on Cycle 1 Day 1 for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks of treatment. Cycles are repeated every 4 weeks.
11048871|NCT01297244|EG001|Reported Event|Non-Clear Cell RCC|Subjects received 1.5 mg tivozanib orally once daily beginning on Cycle 1 Day 1 for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks of treatment. Cycles are repeated every 4 weeks.
11048872|NCT01297257|BG000|Baseline|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
11048873|NCT01297257|FG000|Participant Flow|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
11048874|NCT01297257|OG000|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7,740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 10,733 Resolute Integrity™ Stents
11048875|NCT01297257|OG000|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
11048876|NCT01297257|EG000|Reported Event|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
11048877|NCT01297270|BG000|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
11048878|NCT01297270|BG001|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
11048879|NCT01297270|BG002|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
11048880|NCT01297270|BG003|Baseline|Total|Total of all reporting groups
11048881|NCT01297270|FG000|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
11048882|NCT01297270|FG001|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
11048883|NCT01297270|FG002|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
11048884|NCT01297270|OG000|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
11048885|NCT01297270|OG001|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
11048886|NCT01297270|OG002|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
11048887|NCT01297270|EG000|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
11048888|NCT01297270|EG001|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
11048889|NCT01297270|EG002|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
11048890|NCT01297283|BG000|Baseline|Overall Subjects|
11048891|NCT01297283|FG000|Participant Flow|Overall Subjects|Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device
11048892|NCT01297283|OG000|Outcome|Overall Subjects|
11048893|NCT01297283|EG000|Reported Event|Overall Subjects|
11048894|NCT01297309|BG000|Baseline|rhPTH (1-84)|Participants received rhPTH (1-84) subcutaneous injection with a starting dose of 25 or 50 microgram (mcg) once daily with dose adjusted by the investigator with upwards in increments of 25 mcg up to 100 mcg daily, with the goal to achieve or maintain total serum calcium levels in the range of 8.0 to 9.0 milligrams per deciliter (mg/dL).
11048895|NCT01297309|FG000|Participant Flow|rhPTH(1-84)|Participants received rhPTH (1-84) subcutaneous injection with a starting dose of 25 or 50 microgram (mcg) once daily with dose adjusted by the investigator with upwards in increments of 25 mcg up to 100 mcg daily, with the goal to achieve or maintain total serum calcium levels in the range of 8.0 to 9.0 milligrams per deciliter (mg/dL).
11048896|NCT01297309|OG000|Outcome|rhPTH (1-84)|Participants received rhPTH (1-84) subcutaneous injection with a starting dose of 25 or 50 microgram (mcg) once daily with dose adjusted by the investigator with upwards in increments of 25 mcg up to 100 mcg daily, with the goal to achieve or maintain total serum calcium levels in the range of 8.0 to 9.0 milligrams per deciliter (mg/dL).
11048897|NCT01297309|EG000|Reported Event|rhPTH(1-84)|Participants received rhPTH (1-84) subcutaneous injection with a starting dose of 25 or 50 microgram (mcg) once daily with dose adjusted by the investigator with upwards in increments of 25 mcg up to 100 mcg daily, with the goal to achieve or maintain total serum calcium levels in the range of 8.0 to 9.0 milligrams per deciliter (mg/dL).
11048898|NCT01297322|BG000|Baseline|Manual Compression|Manual compression: Standard of Care
11048899|NCT01297322|BG001|Baseline|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
11048900|NCT01297322|BG002|Baseline|Total|Total of all reporting groups
11048901|NCT01297322|FG000|Participant Flow|Manual Compression|Manual compression: Standard of Care
11048902|NCT01297322|FG001|Participant Flow|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
11048903|NCT01297322|OG000|Outcome|Manual Compression|Manual compression: Standard of Care
11048904|NCT01297322|OG001|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
11048905|NCT01297322|OG000|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
11048906|NCT01297322|EG000|Reported Event|Manual Compression|Manual compression: Standard of Care
11048907|NCT01297322|EG001|Reported Event|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
11048908|NCT01297335|BG000|Baseline|Intrathecal Clonidine|All subjects met all inclusion and exclusionary criteria, and we report study subjects' demographic information in following sections.
11048909|NCT01297335|FG000|Participant Flow|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
11048910|NCT01297335|OG000|Outcome|Intrathecal Clonidine|Subject received one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
11048911|NCT01297335|OG000|Outcome|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
11048912|NCT01297335|OG000|Outcome|Intrathecal Clonidine|Subjects were asked to rate both level of sedation and dryness of their mouths (two of the most common side effects of clonidine) at before clonidine injection (baseline) and at one hour after clonidine injection (Post injection) on VAS scale. VAS scale is an analogue scale that measures subject response from 0 to 10 cm, where larger value represents greater level of sedation and dryness in the mouth subject experienced.
11048913|NCT01297335|EG000|Reported Event|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
11048914|NCT01297348|BG000|Baseline|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
11048915|NCT01297348|BG001|Baseline|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
11048916|NCT01297348|BG002|Baseline|Total|Total of all reporting groups
11048917|NCT01297348|FG000|Participant Flow|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
11048918|NCT01297348|FG001|Participant Flow|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
11048919|NCT01297348|OG000|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
11048920|NCT01297348|OG001|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
11048921|NCT01297348|OG002|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
11048922|NCT01297348|EG000|Reported Event|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
11048923|NCT01297348|EG001|Reported Event|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
11048924|NCT01297465|BG000|Baseline|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
11048925|NCT01297465|BG001|Baseline|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
11048926|NCT01297465|BG002|Baseline|Total|Total of all reporting groups
11048927|NCT01297465|FG000|Participant Flow|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
11226483|NCT02375347|EG000|Reported Event|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
11226484|NCT02375373|BG000|Baseline|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
11048928|NCT01297465|FG001|Participant Flow|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
11048929|NCT01297465|OG000|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
11048930|NCT01297465|OG001|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
11048931|NCT01297465|EG000|Reported Event|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
11048932|NCT01297465|EG001|Reported Event|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
11048933|NCT01297491|BG000|Baseline|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
11048934|NCT01297491|BG001|Baseline|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
11048935|NCT01297491|BG002|Baseline|Total|Total of all reporting groups
11048936|NCT01297491|FG000|Participant Flow|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
11048937|NCT01297491|FG001|Participant Flow|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
11048938|NCT01297491|OG000|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
11048939|NCT01297491|OG001|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
11048940|NCT01297491|EG000|Reported Event|Squamous BKM120 100 mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
11048941|NCT01297491|EG001|Reported Event|Non-Squamous BKM120 100 mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
11048942|NCT01297504|BG000|Baseline|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
11048943|NCT01297504|FG000|Participant Flow|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
11048944|NCT01297504|OG000|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
11048945|NCT01297504|OG000|Outcome|LTRI|Hospitalizations due to lower respiratory tract infections (LRTI).
11048946|NCT01297504|OG001|Outcome|LTRI Due to RSV|Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
11048947|NCT01297504|OG000|Outcome|Univariate|
11048948|NCT01297504|OG001|Outcome|Multivariate|
11048949|NCT01297504|EG000|Reported Event|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
11048950|NCT01297517|BG000|Baseline|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048951|NCT01297517|BG001|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048952|NCT01297517|BG002|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048953|NCT01297517|BG003|Baseline|Total|Total of all reporting groups
11048954|NCT01297517|FG000|Participant Flow|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048955|NCT01297517|FG001|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048956|NCT01297517|FG002|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048957|NCT01297517|OG000|Outcome|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048958|NCT01297517|OG001|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048959|NCT01297517|OG002|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048960|NCT01297517|EG000|Reported Event|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048961|NCT01297517|EG001|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048962|NCT01297517|EG002|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
11048963|NCT01297595|BG000|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg FC first and crizotinib 250 mg OLF first.
11048964|NCT01297595|FG000|Participant Flow|Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 milligram (mg) formulated capsule (FC) in first intervention period; and single oral dose of crizotinib 250 mg oral liquid formulation (OLF) in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
11048965|NCT01297595|FG001|Participant Flow|Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg OLF in first intervention period; and single oral dose of crizotinib 250 mg FC in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
11048966|NCT01297595|OG000|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
11048967|NCT01297595|OG001|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
11048968|NCT01297595|EG000|Reported Event|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
11048969|NCT01297595|EG001|Reported Event|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
11048970|NCT01297920|BG000|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
11348985|NCT04132336|BG000|Baseline|Naproxen Sodium/Caffeine-Dose 1|Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
11048971|NCT01297920|BG001|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
11048972|NCT01297920|BG002|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
11048973|NCT01297920|BG003|Baseline|Total|Total of all reporting groups
11048974|NCT01297920|FG000|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
11048975|NCT01297920|FG001|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
11048976|NCT01297920|FG002|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
11048977|NCT01297920|OG000|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
11048978|NCT01297920|OG001|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
11048979|NCT01297920|OG002|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
11048980|NCT01297920|EG000|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
11048981|NCT01297920|EG001|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
11048982|NCT01297920|EG002|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
11048983|NCT01297959|BG000|Baseline|E-101 Solution 300 GU/mL|Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
11048984|NCT01297959|BG001|Baseline|Placebo (Saline Solution)|Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
11048985|NCT01297959|BG002|Baseline|Total|Total of all reporting groups
11048986|NCT01297959|FG000|Participant Flow|E-101 Solution 300 GU/mL|Participants received 8 milliliter (mL) of E-101 Solution at porcine myeloperoxidase (pMPO) concentration of 300 guaiacol units per milliliter (GU/mL) applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
11048987|NCT01297959|FG001|Participant Flow|Placebo (Saline Solution)|Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
11048988|NCT01297959|OG000|Outcome|E-101 Solution 300 GU/mL|Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
11048989|NCT01297959|OG001|Outcome|Placebo (Saline Solution)|Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
11048990|NCT01297959|EG000|Reported Event|E-101 Solution 300 GU/mL|Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
11048991|NCT01297959|EG001|Reported Event|Placebo (Saline Solution)|Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
11048992|NCT01297985|BG000|Baseline|BRIDGES Intervention|BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
11048993|NCT01297985|BG001|Baseline|Comparison Wait-list Group|Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
11048994|NCT01297985|BG002|Baseline|Total|Total of all reporting groups
11048995|NCT01297985|FG000|Participant Flow|BRIDGES Intervention|BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
11048996|NCT01297985|FG001|Participant Flow|Comparison Wait-list Group|Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
11048997|NCT01297985|OG000|Outcome|BRIDGES Intervention|BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
11048998|NCT01297985|OG001|Outcome|Comparison Wait-list Group|Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
11048999|NCT01297985|EG000|Reported Event|BRIDGES Intervention|BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
11049000|NCT01297985|EG001|Reported Event|Comparison Wait-list Group|Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
11049001|NCT01298063|BG000|Baseline|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
11049002|NCT01298063|BG001|Baseline|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
11049003|NCT01298063|BG002|Baseline|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
11049004|NCT01298063|BG003|Baseline|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
11049005|NCT01298063|BG004|Baseline|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
11049006|NCT01298063|BG005|Baseline|Total|Total of all reporting groups
11049007|NCT01298063|FG000|Participant Flow|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
10846975|NCT00281528|EG000|Reported Event|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
11049008|NCT01298063|FG001|Participant Flow|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
11049009|NCT01298063|FG002|Participant Flow|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
11049010|NCT01298063|FG003|Participant Flow|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
11049011|NCT01298063|FG004|Participant Flow|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
11049012|NCT01298063|OG000|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
11049013|NCT01298063|OG001|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
11049014|NCT01298063|OG002|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
11049015|NCT01298063|OG003|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
11049016|NCT01298063|OG004|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
11049017|NCT01298063|OG000|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
11049018|NCT01298063|EG000|Reported Event|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
11049019|NCT01298063|EG001|Reported Event|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
11049020|NCT01298063|EG002|Reported Event|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
11049021|NCT01298063|EG003|Reported Event|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
11049022|NCT01298063|EG004|Reported Event|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
11049023|NCT01298128|BG000|Baseline|NuvaRing|NuvaRing for IVF pre-treatment
11049024|NCT01298128|BG001|Baseline|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
11049025|NCT01298128|BG002|Baseline|Total|Total of all reporting groups
11049026|NCT01298128|FG000|Participant Flow|NuvaRing|NuvaRing for IVF pre-treatment
11049027|NCT01298128|FG001|Participant Flow|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
11049028|NCT01298128|OG000|Outcome|NuvaRing|NuvaRing for IVF pre-treatment
11049029|NCT01298128|OG001|Outcome|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
11049030|NCT01298128|EG000|Reported Event|NuvaRing|NuvaRing for IVF pre-treatment
11049031|NCT01298128|EG001|Reported Event|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
11049032|NCT01298141|BG000|Baseline|Replagal (Agalsidase Alfa)|Participants in cohort 1 received Replagal AF IV infusion at a dose of 0.2 mg/kg body weight EOW and cohort 2 received Replagal AF IV infusion at a dose of 0.2 mg/kg body weight weekly until the drug became commercially available or the participant discontinued, whichever came first.
11049033|NCT01298141|FG000|Participant Flow|Replagal (Agalsidase Alfa)|Participants in cohort 1 received Replagal AF intravenous (IV) infusion at a dose of 0.2 milligram per kilogram (mg/kg) body weight every other week (EOW) and cohort 2 received Replagal AF IV infusion at a dose of 0.2 mg/kg body weight weekly until the drug became commercially available or the participant discontinued, whichever came first.
11049034|NCT01298141|OG000|Outcome|Replagal (Agalsidase Alfa)|Participants in cohort 1 received Replagal AF IV infusion at a dose of 0.2 mg/kg body weight EOW and cohort 2 received Replagal AF IV infusion at a dose of 0.2 mg/kg body weight weekly until the drug became commercially available or the participant discontinued, whichever came first.
11049035|NCT01298141|EG000|Reported Event|Replagal (Agalsidase Alfa)|Participants in cohort 1 received Replagal AF IV infusion at a dose of 0.2 mg/kg body weight EOW and cohort 2 received Replagal AF IV infusion at a dose of 0.2 mg/kg body weight weekly until the drug became commercially available or the participant discontinued, whichever came first.
11049036|NCT01298167|BG000|Baseline|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
11049037|NCT01298167|BG001|Baseline|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
11049038|NCT01298167|BG002|Baseline|Total|Total of all reporting groups
11049039|NCT01298167|FG000|Participant Flow|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
11049040|NCT01298167|FG001|Participant Flow|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
11049041|NCT01298167|OG000|Outcome|Cyanoacrylate Superior/Inferior|Combined measures of Cyanoacrylate used on both the superior and inferior halves of wounds.
11049042|NCT01298167|OG001|Outcome|FAG Superior/Inferior|Combined measures of Fast Absorbing Gut Suture used on both the superior and inferior halves of wounds.
11049043|NCT01298167|EG000|Reported Event|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
11049044|NCT01298167|EG001|Reported Event|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
11049045|NCT01298193|BG000|Baseline|Aprepitant|"Observational phase (first cycle):~Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).~• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).~Efficacy phase (second cycle):~Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg).~Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg).~Aprepitant: Efficacy phase (second cycle)"
11049046|NCT01298193|FG000|Participant Flow|Aprepitant|"Observational phase (first cycle):~Day 0: Dexamethasone 8mg Day 1: 5-HydroxyTryptamine 3 (5-HT3) antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg.~• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3: Dexamethasone 16 mg.~Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):~Day 0: dexamethasone oral (8 mg Day 1: iv/oral* 5-hydroxytryptamine 3 [5-HT3] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg~• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg"
11049047|NCT01298193|OG000|Outcome|Observational Phase (First Cycle):|"Observational phase (first cycle):~Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 [5-HT3] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).~• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg)."
11049048|NCT01298193|OG000|Outcome|Aprepitant NCR|"Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):~Day 0: dexamethasone oral (8 mg Day 1: iv/oral* 5-hydroxytryptamine 3 [5-HT3] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg~• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg"
11049049|NCT01298193|OG000|Outcome|Aprepitant|"Observational phase (first cycle):~Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 [5-HT3] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).~• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).~Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):~Day 0: dexamethasone oral (8 mg Day 1: iv/oral* 5-hydroxytryptamine 3 [5-HT3] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg~• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg"
11049050|NCT01298193|EG000|Reported Event|Observational Phase (First Cycle):|"Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).~• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg)."
11049051|NCT01298193|EG001|Reported Event|Efficacy Phase (Second Cycle):|"Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg).~Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg)."
11049052|NCT01298219|BG000|Baseline|Lubiprostone|"24 mcg capsules twice daily (BID)~Lubiprostone: 24 mcg administered orally twice daily (BID)"
11049053|NCT01298219|BG001|Baseline|Placebo|"0 mcg capsules twice daily (BID)~Placebo: Matching placebo, 0 mcg administered orally twice daily (BID)"
11049054|NCT01298219|BG002|Baseline|Total|Total of all reporting groups
11049055|NCT01298219|FG000|Participant Flow|Lubiprostone|"24 mcg capsules twice daily (BID)~Lubiprostone: 24 mcg administered orally twice daily (BID)"
11049056|NCT01298219|FG001|Participant Flow|Placebo|"0 mcg capsules twice daily (BID)~Placebo: Matching placebo, 0 mcg administered orally twice daily (BID)"
11049057|NCT01298219|OG000|Outcome|Lubiprostone|"24 mcg capsules twice daily (BID)~Lubiprostone: 24 mcg administered orally twice daily (BID)"
11049058|NCT01298219|OG001|Outcome|Placebo|"0 mcg capsules twice daily (BID)~Placebo: Matching placebo, 0 mcg administered orally twice daily (BID)"
11049059|NCT01298219|EG000|Reported Event|Lubiprostone|"24 mcg capsules twice daily (BID)~Lubiprostone: 24 mcg administered orally twice daily (BID)"
11049060|NCT01298219|EG001|Reported Event|Placebo|"0 mcg capsules twice daily (BID)~Placebo: Matching placebo, 0 mcg administered orally twice daily (BID)"
11049061|NCT01298323|BG000|Baseline|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
11049062|NCT01298323|BG001|Baseline|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
11049063|NCT01298323|BG002|Baseline|Total|Total of all reporting groups
11049064|NCT01298323|FG000|Participant Flow|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
11049065|NCT01298323|FG001|Participant Flow|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
11049066|NCT01298323|OG000|Outcome|Vandetanib 300 mg+Outreach Program|Patients on this arm will be contacted by site personnel at week 1 and then every 2 weeks during the first 52 weeks on the study (or prior discontinuation) to detect and possibly treat adverse events sooner than they might have been without the patient outreach, and at a time of lesser CTCAE grade.
11049067|NCT01298323|OG001|Outcome|Vandetanib 300 mg|Patients on this arm will get a standard AE monitoring schedule, similar to that used on previous studies. Patients will be asked about any AEs at scheduled visits and will have the option to contact the investigator at any time if experiencing any AE or symptoms and discuss the best treatment options.
11049068|NCT01298323|EG000|Reported Event|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
11049069|NCT01298323|EG001|Reported Event|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
11049070|NCT01298362|BG000|Baseline|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
11049071|NCT01298362|BG001|Baseline|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
11049072|NCT01298362|BG002|Baseline|Total|Total of all reporting groups
10846976|NCT00281528|EG001|Reported Event|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
11049073|NCT01298362|FG000|Participant Flow|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
11049074|NCT01298362|FG001|Participant Flow|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
11049075|NCT01298362|OG000|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
11049076|NCT01298362|OG001|Outcome|HT Cohort|"In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.~The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group.~BMD measurements in HT cohort were taken before AI start and at 12 months."
11049077|NCT01298362|OG001|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
11049078|NCT01298362|OG001|Outcome|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
11049079|NCT01298362|EG000|Reported Event|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
11049080|NCT01298362|EG001|Reported Event|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
11049081|NCT01298492|BG000|Baseline|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
11049082|NCT01298492|FG000|Participant Flow|PF-00547659 75 mg|Participants received PF-00547659 75 milligram (mg) subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
11049083|NCT01298492|OG000|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
11049084|NCT01298492|EG000|Reported Event|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
10846977|NCT00281528|EG002|Reported Event|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
10846978|NCT00281580|BG000|Baseline|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
11049085|NCT01298518|BG000|Baseline|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
11049086|NCT01298518|BG001|Baseline|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
11049087|NCT01298518|BG002|Baseline|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
11049088|NCT01298518|BG003|Baseline|Total|Total of all reporting groups
11049089|NCT01298518|FG000|Participant Flow|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
11049090|NCT01298518|FG001|Participant Flow|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
11049091|NCT01298518|FG002|Participant Flow|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
11049092|NCT01298518|OG000|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
11049093|NCT01298518|OG001|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
11049094|NCT01298518|OG002|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
11049095|NCT01298518|EG000|Reported Event|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
11049096|NCT01298518|EG001|Reported Event|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
11049097|NCT01298518|EG002|Reported Event|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
10846979|NCT00281580|BG001|Baseline|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
10846980|NCT00281580|BG002|Baseline|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
10846981|NCT00281580|BG003|Baseline|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
11049098|NCT01298531|BG000|Baseline|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
11049099|NCT01298531|BG001|Baseline|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
11049100|NCT01298531|BG002|Baseline|Total|Total of all reporting groups
11049101|NCT01298531|FG000|Participant Flow|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
11049102|NCT01298531|FG001|Participant Flow|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
11049103|NCT01298531|OG000|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
11049104|NCT01298531|OG001|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
11049105|NCT01298531|OG000|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
11348986|NCT04132336|BG001|Baseline|Naproxen Sodium/Caffeine-Dose 2|Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
11049106|NCT01298531|EG000|Reported Event|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
11049107|NCT01298531|EG001|Reported Event|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
11049108|NCT01298544|BG000|Baseline|Entire Study Population|All randomized participants
11049109|NCT01298544|FG000|Participant Flow|Entire Study Population|All randomized participants
11049110|NCT01298544|OG000|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
11049111|NCT01298544|OG001|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
11049112|NCT01298544|OG002|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
11049113|NCT01298544|EG000|Reported Event|Entire Study Population|All randomized participants
11049114|NCT01298570|BG000|Baseline|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
11049115|NCT01298570|BG001|Baseline|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
11049116|NCT01298570|BG002|Baseline|Total|Total of all reporting groups
11049117|NCT01298570|FG000|Participant Flow|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
11049118|NCT01298570|FG001|Participant Flow|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
11049119|NCT01298570|OG000|Outcome|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
11049120|NCT01298570|OG001|Outcome|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
11049121|NCT01298570|EG000|Reported Event|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
11049122|NCT01298570|EG001|Reported Event|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
11049123|NCT01298596|BG000|Baseline|Cryotherapy|"Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix~Cryotherapy: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix"
11049124|NCT01298596|BG001|Baseline|Loop Electrosurgical Excision Procedure|"Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix~Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix"
11049125|NCT01298596|BG002|Baseline|Total|Total of all reporting groups
11049126|NCT01298596|FG000|Participant Flow|Cryotherapy|"Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix~Cryotherapy: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix"
11049127|NCT01298596|FG001|Participant Flow|Loop Electrosurgical Excision Procedure|"Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix~Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix"
11049128|NCT01298596|OG000|Outcome|Cryotherapy|"Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix~Cryotherapy: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix"
11049129|NCT01298596|OG001|Outcome|Loop Electrosurgical Excision Procedure|"Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix~Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix"
11049130|NCT01298596|EG000|Reported Event|Cryotherapy|"Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix~Cryotherapy: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix"
11049131|NCT01298596|EG001|Reported Event|Loop Electrosurgical Excision Procedure|"Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix~Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix"
11049132|NCT01298648|BG000|Baseline|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
11049133|NCT01298648|FG000|Participant Flow|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
11049134|NCT01298648|OG000|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
11049135|NCT01298648|EG000|Reported Event|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
11049136|NCT01298661|BG000|Baseline|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
11049137|NCT01298661|BG001|Baseline|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
11049138|NCT01298661|BG002|Baseline|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
11049139|NCT01298661|BG003|Baseline|Total|Total of all reporting groups
11049140|NCT01298661|FG000|Participant Flow|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
11049141|NCT01298661|FG001|Participant Flow|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
11049142|NCT01298661|FG002|Participant Flow|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
11049143|NCT01298661|OG000|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
11049144|NCT01298661|OG001|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
11049145|NCT01298661|OG002|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
11049146|NCT01298661|OG000|Outcome|COPD Patients|Patients with clinical and spirometrical diagnosis of Chronic Obstructive Pulmonary Disease
11049147|NCT01298661|EG000|Reported Event|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
11348987|NCT04132336|BG002|Baseline|Naproxen Sodium/Caffeine-Dose 3|Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
11049148|NCT01298661|EG001|Reported Event|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
11049149|NCT01298661|EG002|Reported Event|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
11049150|NCT01298700|BG000|Baseline|Bimatoprost 0.01% Ophthalmic Solution|One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
11049151|NCT01298700|BG001|Baseline|Bimatoprost 0.03% Ophthalmic Solution|One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
11049152|NCT01298700|BG002|Baseline|Total|Total of all reporting groups
11049153|NCT01298700|FG000|Participant Flow|Bimatoprost 0.01% Ophthalmic Solution|One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
11049154|NCT01298700|FG001|Participant Flow|Bimatoprost 0.03% Ophthalmic Solution|One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
11049155|NCT01298700|OG000|Outcome|Bimatoprost 0.01% Ophthalmic Solution|One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
11049156|NCT01298700|OG001|Outcome|Bimatoprost 0.03% Ophthalmic Solution|One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
11049157|NCT01298700|EG000|Reported Event|Bimatoprost 0.01% Ophthalmic Solution|One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
11049158|NCT01298700|EG001|Reported Event|Bimatoprost 0.03% Ophthalmic Solution|One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
11049159|NCT01298752|BG000|Baseline|Mapracorat|"Mapracorat ophthalmic suspension~Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks."
11049160|NCT01298752|BG001|Baseline|Vehicle|"Vehicle of mapracorat ophthalmic suspension~Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks."
11049161|NCT01298752|BG002|Baseline|Total|Total of all reporting groups
11049162|NCT01298752|FG000|Participant Flow|Mapracorat|"Mapracorat ophthalmic suspension~Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks."
10846982|NCT00281580|BG004|Baseline|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
11049163|NCT01298752|FG001|Participant Flow|Vehicle|"Vehicle of mapracorat ophthalmic suspension~Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks."
11049164|NCT01298752|OG000|Outcome|Mapracorat|"Mapracorat ophthalmic suspension~Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks."
11049165|NCT01298752|OG001|Outcome|Vehicle|"Vehicle of mapracorat ophthalmic suspension~Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks."
11049166|NCT01298752|EG000|Reported Event|Mapracorat|"Mapracorat ophthalmic suspension~Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks."
11049167|NCT01298752|EG001|Reported Event|Vehicle|"Vehicle of mapracorat ophthalmic suspension~Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks."
11049168|NCT01298765|BG000|Baseline|BEMA Buproneorphine Overall|"buprenorphine buccal soluble film~BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily"
11049169|NCT01298765|FG000|Participant Flow|BEMA Buproneorphine Overall|"buprenorphine buccal soluble film~BEMA Buprenorphine; buccal soluble film; applied to the buccal mucosa twice daily"
11049170|NCT01298765|OG000|Outcome|BEMA Buproneorphine Overall|"buprenorphine buccal soluble film~BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily"
11049171|NCT01298765|EG000|Reported Event|BEMA Buproneorphine Overall|"buprenorphine buccal soluble film~BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily"
11049172|NCT01298778|BG000|Baseline|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
11049173|NCT01298778|BG001|Baseline|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
11049174|NCT01298778|BG002|Baseline|Total|Total of all reporting groups
11049175|NCT01298778|FG000|Participant Flow|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
11049176|NCT01298778|FG001|Participant Flow|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
11049177|NCT01298778|OG000|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
11049178|NCT01298778|OG001|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
11049179|NCT01298778|OG000|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph 150: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
11049180|NCT01298778|OG001|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses~Duramorph 300: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
11049181|NCT01298778|EG000|Reported Event|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
11049182|NCT01298778|EG001|Reported Event|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
11049183|NCT01298999|BG000|Baseline|YF476|"YF476 (gastrin-receptor antagonist)~YF476: 25 mg: one capsule to be taken by mouth once daily for 12 weeks."
11049184|NCT01298999|BG001|Baseline|Placebo|"Placebo pill (identical in appearance to YF476 pills)~Placebo: Matching placebo: one capsule to be taken by mouth once daily for 12 weeks."
11049185|NCT01298999|BG002|Baseline|Total|Total of all reporting groups
11049186|NCT01298999|FG000|Participant Flow|YF476|"YF476 (gastrin-receptor antagonist)~YF476: 25 mg: one capsule to be taken by mouth once daily for 12 weeks."
10846983|NCT00281580|BG005|Baseline|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
11049187|NCT01298999|FG001|Participant Flow|Placebo|"Placebo pill (identical in appearance to YF476 pills)~Placebo: Matching placebo: one capsule to be taken by mouth once daily for 12 weeks."
11049188|NCT01298999|OG000|Outcome|YF476|"YF476 (gastrin-receptor antagonist)~YF476: 25 mg: one capsule to be taken by mouth once daily for 12 weeks."
11049189|NCT01298999|OG001|Outcome|Placebo|"Placebo pill (identical in appearance to YF476 pills)~Placebo: Matching placebo: one capsule to be taken by mouth once daily for 12 weeks."
11049190|NCT01298999|EG000|Reported Event|YF476|"YF476 (gastrin-receptor antagonist)~YF476: 25 mg: one capsule to be taken by mouth once daily for 12 weeks."
11049191|NCT01298999|EG001|Reported Event|Placebo|"Placebo pill (identical in appearance to YF476 pills)~Placebo: Matching placebo: one capsule to be taken by mouth once daily for 12 weeks."
11049192|NCT01299025|BG000|Baseline|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
11049193|NCT01299025|BG001|Baseline|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
11049194|NCT01299025|BG002|Baseline|Total|Total of all reporting groups
11049195|NCT01299025|FG000|Participant Flow|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
11049196|NCT01299025|FG001|Participant Flow|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
11049197|NCT01299025|OG000|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
11049198|NCT01299025|OG001|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
11049199|NCT01299025|EG000|Reported Event|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
11049200|NCT01299025|EG001|Reported Event|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
11049201|NCT01299038|BG000|Baseline|Rosuvastatin 20mg|"Rosuvastatin 20mg taken orally once a day for 4 weeks~rosuvastatin: Taken orally once a day for 4 weeks"
11049202|NCT01299038|BG001|Baseline|Rosuvastatin 40mg|"Rosuvastatin 40mg taken orally once a day for 4 weeks~rosuvastatin: Taken orally once a day for 4 weeks"
11049203|NCT01299038|BG002|Baseline|Total|Total of all reporting groups
11348988|NCT04132336|BG003|Baseline|Naproxen Sodium/Caffeine-Dose 4|Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
11348989|NCT04132336|BG004|Baseline|Naproxen Sodium|Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
11049204|NCT01299038|FG000|Participant Flow|Rosuvastatin 20|Rosuvastatin 20mg taken orally once a day for 4 weeks
11049205|NCT01299038|FG001|Participant Flow|Rosuvastatin 40|Rosuvastatin 40mg taken orally once a day for 4 weeks
11049206|NCT01299038|OG000|Outcome|Rosuvastatin 20mg|"Rosuvastatin 20mg taken orally once a day for 4 weeks~rosuvastatin: Taken orally once a day for 4 weeks"
11049207|NCT01299038|OG001|Outcome|Rosuvastatin 40mg|"Rosuvastatin 40mg taken orally once a day for 4 weeks~rosuvastatin: Taken orally once a day for 4 weeks"
11049208|NCT01299038|EG000|Reported Event|Rosuvastatin 20mg|"Rosuvastatin 20mg taken orally once a day for 4 weeks~rosuvastatin: Taken orally once a day for 4 weeks"
11049209|NCT01299038|EG001|Reported Event|Rosuvastatin 40mg|"Rosuvastatin 40mg taken orally once a day for 4 weeks~rosuvastatin: Taken orally once a day for 4 weeks"
11049210|NCT01299077|BG000|Baseline|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
11049211|NCT01299077|FG000|Participant Flow|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
11049212|NCT01299077|OG000|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
11049213|NCT01299077|EG000|Reported Event|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
11049214|NCT01299090|BG000|Baseline|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
11049215|NCT01299090|FG000|Participant Flow|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
11049216|NCT01299090|OG000|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
11049217|NCT01299090|EG000|Reported Event|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
11049218|NCT01299103|BG000|Baseline|Single Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
11049219|NCT01299103|BG001|Baseline|Double Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
11049220|NCT01299103|BG002|Baseline|Triple Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
11049221|NCT01299103|BG003|Baseline|Total|Total of all reporting groups
11049222|NCT01299103|FG000|Participant Flow|Single Treatment|Subjects receive one treatment
11049223|NCT01299103|FG001|Participant Flow|Double Treatment|Subjects receive two treatments
11049224|NCT01299103|FG002|Participant Flow|Triple Treatment|Subjects receive three treatments
11049225|NCT01299103|OG000|Outcome|Single Treatment|Subjects receive one treatment
11049226|NCT01299103|OG001|Outcome|Double Treatment|Subjects receive two treatments
11049227|NCT01299103|OG002|Outcome|Triple Treatment|Subjects receive three treatments
11049228|NCT01299103|EG000|Reported Event|Single Treatment|Subjects receive one treatment
11049229|NCT01299103|EG001|Reported Event|Double Treatment|Subjects receive two treatments
11049230|NCT01299103|EG002|Reported Event|Triple Treatment|Subjects receive three treatments
11049231|NCT01299116|BG000|Baseline|Preference SARC|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
11049232|NCT01299116|BG001|Baseline|Randomized LARC|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
11049233|NCT01299116|BG002|Baseline|Randomized SARC|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
11049234|NCT01299116|BG003|Baseline|Total|Total of all reporting groups
11049235|NCT01299116|FG000|Participant Flow|SARC - Preference|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
11049236|NCT01299116|FG001|Participant Flow|LARC - Randomized|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
11049237|NCT01299116|FG002|Participant Flow|SARC - Randomized|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®."
11049238|NCT01299116|OG000|Outcome|SARC - Preference|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
11049239|NCT01299116|OG001|Outcome|LARC - Randomized|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
11049240|NCT01299116|OG002|Outcome|SARC - Randomized|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®."
11049241|NCT01299116|OG000|Outcome|Preference SARC|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
11049242|NCT01299116|OG001|Outcome|Randomized LARC|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
11049243|NCT01299116|OG002|Outcome|Randomized SARC|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
11049244|NCT01299116|EG000|Reported Event|SARC - Preference|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
11049245|NCT01299116|EG001|Reported Event|LARC - Randomized|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
11049246|NCT01299116|EG002|Reported Event|SARC - Randomized|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®."
11149177|NCT01869192|BG001|Baseline|Arm B|"Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment~Docetaxel: Docetaxel 75 mg/m2 d1 q3w~Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w~Radiation Therapy: Standard dosing, fields depending on clinical findings"
11149178|NCT01869192|BG002|Baseline|Total|Total of all reporting groups
11049247|NCT01299272|BG000|Baseline|All Enrolled Participants|All enrolled participants started on a flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for an additional 12 weeks. At 20 weeks, participants meeting criteria for randomization either 1) continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks or 2) were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
11049248|NCT01299272|FG000|Participant Flow|LY2216684 + SSRI (Acute Open-label Period)|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
11049249|NCT01299272|FG001|Participant Flow|LY2216684 + SSRI (Stabilization Open-label Period)|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for an additional 12 weeks.
11049250|NCT01299272|FG002|Participant Flow|LY2216684 + SSRI (Double-blind Randomized Withdrawal Period)|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
11049251|NCT01299272|FG003|Participant Flow|Placebo + SSRI (Double-blind Randomized Withdrawal Period)|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
11049252|NCT01299272|OG000|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
11049253|NCT01299272|OG001|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
11049254|NCT01299272|OG000|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
11226485|NCT02375373|FG000|Participant Flow|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
11049255|NCT01299272|OG000|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
11049256|NCT01299272|EG000|Reported Event|LY2216684 + SSRI (Acute Open-label Period)|"Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all enrolled participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Acute Open-label Period."
11049257|NCT01299272|EG001|Reported Event|LY2216684 + SSRI (Stabilization Open-label Period)|"Same, stable dose of LY2216684 as in the Acute Open-label Period, orally, once daily (QD) for 12 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all participants who completed the Acute Open-label Period and did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Stabilization Open-label Period."
11049258|NCT01299272|EG002|Reported Event|LY2216684 + SSRI (Double-blind Randomized Withdrawal Period)|"Same, stable dose of LY2216684 as in the Stabilization Open-label Period, orally, once daily (QD) for 24 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Double-blind Randomized Withdrawal Period."
11049259|NCT01299272|EG003|Reported Event|Placebo + SSRI (Double-blind Randomized Withdrawal Period)|"Placebo, orally, once daily (QD) for 24 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Double-blind Randomized Withdrawal Period."
11049260|NCT01299272|EG004|Reported Event|LY2216684 + SSRI (Randomized Tapered Discontinuation Period)|"12 milligrams (mg) LY2216684 for 4 days, 6 mg LY2216684 for 4 days, then placebo for 6 days, orally, once daily (QD), adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all randomized participants who tapered discontinuation of LY2216684 after completion of or early withdrawal from the Double-blind Randomized Withdrawal Period and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation Period visit."
11049261|NCT01299272|EG005|Reported Event|LY2216684 + SSRI (Randomized Abrupt Discontinuation Period)|"Placebo, orally, once daily (QD) for 2 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all randomized participants who abruptly discontinued LY2216684 after completion of or early withdrawal from the Double-blind Randomized Withdrawal Period and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation Period visit."
11348990|NCT04132336|BG005|Baseline|Caffeine|Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
11049262|NCT01299272|EG006|Reported Event|Placebo + SSRI (Abrupt Discontinuation Period)|"Placebo, orally, once daily (QD) for 2 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all randomized participants who discontinued placebo after completion of or early withdrawal from the Double-blind Randomized Withdrawal Period and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation Period visit."
11049263|NCT01299272|EG007|Reported Event|LY2216684 + SSRI (Nonrandomized Abrupt Discontinuation Period)|"Placebo, orally, once daily (QD) for 2 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all non-randomized participants who discontinued early from either Open-label Period and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation Period visit."
11049264|NCT01299285|BG000|Baseline|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
11049265|NCT01299285|FG000|Participant Flow|LY3009104 (Baricitinib)|Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
11049266|NCT01299285|OG000|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
11049267|NCT01299285|OG000|Outcome|LY3009104|The percentage of total radioactivity of LY3009104 (parent) in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
11049268|NCT01299285|OG001|Outcome|LY3009104 Metabolites|The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
11049269|NCT01299285|EG000|Reported Event|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
11049270|NCT01299376|BG000|Baseline|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
11049271|NCT01299376|BG001|Baseline|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
11049272|NCT01299376|BG002|Baseline|Total|Total of all reporting groups
11049273|NCT01299376|FG000|Participant Flow|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
11049274|NCT01299376|FG001|Participant Flow|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
11049275|NCT01299376|OG000|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
11049276|NCT01299376|OG001|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
11049277|NCT01299376|OG000|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
11049278|NCT01299376|OG001|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
11049279|NCT01299376|EG000|Reported Event|L50/H12.5- Double Blind Treatment Period|Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks
11049280|NCT01299376|EG001|Reported Event|L50/H12.5/A5 - Double Blind Treatment Period|Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks
11049281|NCT01299376|EG002|Reported Event|L50/H12.5/A5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period.
11049282|NCT01299376|EG003|Reported Event|L50/H12.5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period.
11049283|NCT01299389|BG000|Baseline|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
11049284|NCT01299389|BG001|Baseline|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
11049285|NCT01299389|BG002|Baseline|Total|Total of all reporting groups
11049286|NCT01299389|FG000|Participant Flow|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
11049287|NCT01299389|FG001|Participant Flow|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
11049288|NCT01299389|FG002|Participant Flow|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
11049289|NCT01299389|FG003|Participant Flow|Paliperidone Palmitate (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
11049290|NCT01299389|OG000|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularl (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
11049291|NCT01299389|OG001|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
11049292|NCT01299389|OG000|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
11049293|NCT01299389|EG000|Reported Event|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
11049294|NCT01299389|EG001|Reported Event|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
11049295|NCT01299389|EG002|Reported Event|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
11049296|NCT01299389|EG003|Reported Event|Paliperidone Palmitate (Post-0bservational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
11049297|NCT01299454|BG000|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049298|NCT01299454|BG001|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049299|NCT01299454|BG002|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049300|NCT01299454|BG003|Baseline|Normal Hepatic Function|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049301|NCT01299454|BG004|Baseline|Total|Total of all reporting groups
11049302|NCT01299454|FG000|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 milligrams (mg).
11049303|NCT01299454|FG001|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme)received a single dose of oral brexpiprazole 2 mg.
11049304|NCT01299454|FG002|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
11049305|NCT01299454|FG003|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
11049306|NCT01299454|OG000|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
10846984|NCT00281580|BG006|Baseline|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
11049307|NCT01299454|OG001|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049308|NCT01299454|OG002|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049309|NCT01299454|OG003|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049310|NCT01299454|OG004|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049311|NCT01299454|OG005|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049312|NCT01299454|OG000|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
11049313|NCT01299454|OG001|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049314|NCT01299454|OG002|Outcome|Moderate Hepatic Impairment.|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049315|NCT01299454|OG003|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049316|NCT01299454|OG004|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049317|NCT01299454|OG005|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
11049318|NCT01299454|OG001|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049319|NCT01299454|OG003|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049320|NCT01299454|OG005|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
11049321|NCT01299454|OG004|Outcome|Severe Hepatic Impairment|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049322|NCT01299454|OG005|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a particpant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049323|NCT01299454|OG001|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participant with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049324|NCT01299454|OG005|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant ith hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049325|NCT01299454|OG005|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049326|NCT01299454|OG001|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participants with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Partipants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049327|NCT01299454|OG000|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049328|NCT01299454|OG002|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049329|NCT01299454|OG003|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
11049330|NCT01299454|OG004|Outcome|Sever Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049331|NCT01299454|OG003|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
11049332|NCT01299454|OG002|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
11049333|NCT01299454|OG001|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049334|NCT01299454|OG002|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11348991|NCT04132336|BG006|Baseline|Placebo|Participants received a single dose of two tablets of matching placebo after extraction of third molars
11049335|NCT01299454|OG003|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11348992|NCT04132336|BG007|Baseline|Total|Total of all reporting groups
11348993|NCT04132336|FG000|Participant Flow|Naproxen Sodium/Caffeine-Dose 1|Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
11049336|NCT01299454|EG000|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049337|NCT01299454|EG001|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049338|NCT01299454|EG002|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049339|NCT01299454|EG003|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
11049340|NCT01299480|BG000|Baseline|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
11049341|NCT01299480|BG001|Baseline|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
11049342|NCT01299480|BG002|Baseline|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
11049343|NCT01299480|BG003|Baseline|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
11049344|NCT01299480|BG004|Baseline|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
11049345|NCT01299480|BG005|Baseline|Total|Total of all reporting groups
11049346|NCT01299480|FG000|Participant Flow|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
11049347|NCT01299480|FG001|Participant Flow|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
11049348|NCT01299480|FG002|Participant Flow|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
11049349|NCT01299480|FG003|Participant Flow|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
11049350|NCT01299480|FG004|Participant Flow|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
11049351|NCT01299480|OG000|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
11049352|NCT01299480|OG001|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
11049353|NCT01299480|OG002|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
11049354|NCT01299480|OG003|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
11049355|NCT01299480|OG004|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
11049356|NCT01299480|OG000|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
11049357|NCT01299480|EG000|Reported Event|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
11049358|NCT01299480|EG001|Reported Event|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
11049359|NCT01299480|EG002|Reported Event|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
11049360|NCT01299480|EG003|Reported Event|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
11049361|NCT01299480|EG004|Reported Event|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
11049362|NCT01299571|BG000|Baseline|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
11049363|NCT01299571|FG000|Participant Flow|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily.
11049364|NCT01299571|OG000|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
11049365|NCT01299571|OG000|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
11049366|NCT01299571|EG000|Reported Event|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
11049367|NCT01299584|BG000|Baseline|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
11049368|NCT01299584|FG000|Participant Flow|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
11049369|NCT01299584|OG000|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
11049370|NCT01299584|EG000|Reported Event|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
11049371|NCT01299610|BG000|Baseline|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049372|NCT01299610|BG001|Baseline|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049373|NCT01299610|BG002|Baseline|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049374|NCT01299610|BG003|Baseline|Total|Total of all reporting groups
11049375|NCT01299610|FG000|Participant Flow|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086 2.0% cream, GW870086 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049376|NCT01299610|FG001|Participant Flow|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049377|NCT01299610|FG002|Participant Flow|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086 0.2% cream, FP 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11149179|NCT01869192|FG000|Participant Flow|Arm A: EC Prior to Surgery, Then XT|"Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment~Epirubicin: Epirubicin 90 mg/m2 d1 q3w~Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w~Radiation Therapy: Standard dosing, fields depending on clinical findings"
11348994|NCT04132336|FG001|Participant Flow|Naproxen Sodium/Caffeine-Dose 2|Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
11348995|NCT04132336|FG002|Participant Flow|Naproxen Sodium/Caffeine-Dose 3|Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
11049378|NCT01299610|OG000|Outcome|GW870086, 0.2% Cream|Participants applied GW870086, 0.2% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049379|NCT01299610|OG001|Outcome|GW870086, 2.0% Cream|Eligible participants applied GW870086, 2.0% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049380|NCT01299610|OG002|Outcome|Placebo|Eligible participants applied matching placebo to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049381|NCT01299610|OG003|Outcome|FP, 0.05% Cream|Eligible participants applied FP, 0.05% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049382|NCT01299610|OG000|Outcome|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049383|NCT01299610|OG001|Outcome|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049384|NCT01299610|OG002|Outcome|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11149180|NCT01869192|FG001|Participant Flow|Arm B: XT Prior to Surgery, Then EC|"Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment~Docetaxel: Docetaxel 75 mg/m2 d1 q3w~Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w~Radiation Therapy: Standard dosing, fields depending on clinical findings"
11348996|NCT04132336|FG003|Participant Flow|Naproxen Sodium/Caffeine-Dose 4|Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
11049385|NCT01299610|EG000|Reported Event|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049386|NCT01299610|EG001|Reported Event|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049387|NCT01299610|EG002|Reported Event|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
11049388|NCT01299727|BG000|Baseline|HGT-1410/rhHNS 10 mg|Participants received HGT-1410/Recombinant human heparan N-sulfatase (rhHNS) 10 milligram (mg) for every 4 weeks (Q4W) via an intrathecal drug delivery device (IDDD).
11049389|NCT01299727|BG001|Baseline|HGT-1410/rhHNS 45 mg|Participants received HGT-1410/rhHNS 45 mg for Q4W via IDDD.
11049390|NCT01299727|BG002|Baseline|HGT-1410/rhHNS 90 mg|Participants received HGT-1410/rhHNS 90 mg for Q4W via IDDD.
11049391|NCT01299727|BG003|Baseline|Total|Total of all reporting groups
11049392|NCT01299727|FG000|Participant Flow|HGT-1410/rhHNS 10 mg|Participants received HGT-1410/Recombinant human heparan N-sulfatase (rhHNS) 10 milligram (mg) for every 4 weeks (Q4W) via an intrathecal drug delivery device (IDDD).
11049393|NCT01299727|FG001|Participant Flow|HGT-1410/rhHNS 45 mg|Participants received HGT-1410/rhHNS 45 mg for Q4W via IDDD.
11049394|NCT01299727|FG002|Participant Flow|HGT-1410/rhHNS 90 mg|Participants received HGT-1410/rhHNS 90 mg for Q4W via IDDD.
11049395|NCT01299727|OG000|Outcome|HGT-1410/rhHNS 10 mg|Participants received HGT-1410/Recombinant human heparan N-sulfatase (rhHNS) 10 milligram (mg) for every 4 weeks (Q4W) via an intrathecal drug delivery device (IDDD).
11049396|NCT01299727|OG001|Outcome|HGT-1410/rhHNS 45 mg|Participants received HGT-1410/rhHNS 45 mg for Q4W via IDDD.
11049397|NCT01299727|OG002|Outcome|HGT-1410/rhHNS 90 mg|Participants received HGT-1410/rhHNS 90 mg for Q4W via IDDD.
11049398|NCT01299727|EG000|Reported Event|HGT-1410/rhHNS-10 mg|Participants received HGT-1410/Recombinant human heparan N-sulfatase (rhHNS) 10 milligram (mg) for every 4 weeks (Q4W) via an intrathecal drug delivery device (IDDD).
11049399|NCT01299727|EG001|Reported Event|HGT-1410/rhHNS-45 mg|Participants received HGT-1410/rhHNS 45 mg for Q4W via IDDD.
11348997|NCT04132336|FG004|Participant Flow|Naproxen Sodium|Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
11049400|NCT01299727|EG002|Reported Event|HGT-1410/rhHNS-90 mg|Participants received HGT-1410/rhHNS 90 mg for Q4W via IDDD.
11049401|NCT01299766|BG000|Baseline|Behavior Activation|"BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.~Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment."
11049402|NCT01299766|BG001|Baseline|Supportive Therapy (ST)|"ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.~Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions."
11049403|NCT01299766|BG002|Baseline|Total|Total of all reporting groups
11049404|NCT01299766|FG000|Participant Flow|Behavior Activation|"BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.~Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment."
11226486|NCT02375373|OG000|Outcome|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
11049405|NCT01299766|FG001|Participant Flow|Supportive Therapy (ST)|"ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.~Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions."
11049406|NCT01299766|OG000|Outcome|Behavior Activation|"BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.~Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment."
11049407|NCT01299766|OG001|Outcome|Supportive Therapy (ST)|"ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.~Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions."
11049408|NCT01299766|EG000|Reported Event|Behavior Activation|"BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.~Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment."
11049409|NCT01299766|EG001|Reported Event|Supportive Therapy (ST)|"ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.~Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions."
11049410|NCT01299805|BG000|Baseline|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
11049411|NCT01299805|BG001|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
11049412|NCT01299805|BG002|Baseline|Total|Total of all reporting groups
11049413|NCT01299805|FG000|Participant Flow|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
11226487|NCT02375373|EG000|Reported Event|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
11049414|NCT01299805|FG001|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
11049415|NCT01299805|OG000|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
11049416|NCT01299805|OG001|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
11049417|NCT01299805|EG000|Reported Event|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
11049418|NCT01299805|EG001|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
11049419|NCT01299896|BG000|Baseline|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
11049420|NCT01299896|BG001|Baseline|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
11049421|NCT01299896|BG002|Baseline|Total|Total of all reporting groups
11049422|NCT01299896|FG000|Participant Flow|Usual Care|"Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (VAPHS), including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
11049423|NCT01299896|FG001|Participant Flow|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
11049424|NCT01299896|OG000|Outcome|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
11049425|NCT01299896|OG001|Outcome|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
11049426|NCT01299896|EG000|Reported Event|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
11049427|NCT01299896|EG001|Reported Event|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
11049428|NCT01299909|BG000|Baseline|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
11049429|NCT01299909|BG001|Baseline|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
11049430|NCT01299909|BG002|Baseline|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
11049431|NCT01299909|BG003|Baseline|Total|Total of all reporting groups
11049432|NCT01299909|FG000|Participant Flow|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
11049433|NCT01299909|FG001|Participant Flow|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
11049434|NCT01299909|FG002|Participant Flow|Quitline|Non-Randomized, Treatment as Usual condition; participants self-selected to this group and received smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL).
11049435|NCT01299909|OG000|Outcome|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
11049436|NCT01299909|OG001|Outcome|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
11049437|NCT01299909|EG000|Reported Event|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
11049438|NCT01299909|EG001|Reported Event|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
11049439|NCT01299909|EG002|Reported Event|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
11049440|NCT01299961|BG000|Baseline|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
11049441|NCT01299961|FG000|Participant Flow|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
10846985|NCT00281580|BG007|Baseline|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
11049442|NCT01299961|OG000|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
11049443|NCT01299961|EG000|Reported Event|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
11049444|NCT01300052|BG000|Baseline|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
11049445|NCT01300052|BG001|Baseline|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
11049446|NCT01300052|BG002|Baseline|Total|Total of all reporting groups
11049447|NCT01300052|FG000|Participant Flow|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator
11049448|NCT01300052|FG001|Participant Flow|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
11049449|NCT01300052|OG000|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
11049450|NCT01300052|OG001|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
11049451|NCT01300052|EG000|Reported Event|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
11049452|NCT01300052|EG001|Reported Event|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
11049453|NCT01300065|BG000|Baseline|Experimental- Soflens|"Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.~Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study"
11348998|NCT04132336|FG005|Participant Flow|Caffeine|Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
11049454|NCT01300065|BG001|Baseline|Marketed - Soflens|"Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.~Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study."
11049455|NCT01300065|BG002|Baseline|Total|Total of all reporting groups
11049456|NCT01300065|FG000|Participant Flow|Experimental- Soflens|"Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.~Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study"
11049457|NCT01300065|FG001|Participant Flow|Marketed - Soflens|"Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.~Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study."
11049458|NCT01300065|OG000|Outcome|Experimental- Soflens|"Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.~Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study"
11049459|NCT01300065|OG001|Outcome|Marketed - Soflens|"Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.~Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study."
11049460|NCT01300065|EG000|Reported Event|Experimental- Soflens|"Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.~Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study"
11049461|NCT01300065|EG001|Reported Event|Marketed - Soflens|"Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.~Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study."
11049462|NCT01300234|BG000|Baseline|TDF-TDF|In first treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks. In second treatment, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049463|NCT01300234|BG001|Baseline|ADV-TDF|In first treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second treatment, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049464|NCT01300234|BG002|Baseline|Total|Total of all reporting groups
11049465|NCT01300234|FG000|Participant Flow|TDF-TDF|In first double-blinded treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049466|NCT01300234|FG001|Participant Flow|ADV-TDF|In first double-blinded treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second open-label treatment, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049467|NCT01300234|OG000|Outcome|TDF 300 mg|Participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks.
11348999|NCT04132336|FG006|Participant Flow|Placebo|Participants received a single dose of two tablets of matching placebo after extraction of third molars
11049468|NCT01300234|OG001|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks.
11049469|NCT01300234|OG000|Outcome|TDF-TDF|In first double-blinded treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049470|NCT01300234|OG001|Outcome|ADV-TDF|In first double-blinded treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049471|NCT01300234|OG000|Outcome|TDF-TDF|In first double-blinded treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg once daily for additional 192 Weeks.
11049472|NCT01300234|OG001|Outcome|ADV-TDF|In first double-blinded treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg once daily for additional 192 Weeks.
11049473|NCT01300234|OG000|Outcome|TDF-TDF|In first treatment double-blinded period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049474|NCT01300234|OG001|Outcome|ADV-TDF|In first treatment double-blinded period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049475|NCT01300234|OG001|Outcome|ADV-TDF|In first double-blinded treatment, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049476|NCT01300234|OG000|Outcome|TDF-TDF|In first double-blinded treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049477|NCT01300234|OG001|Outcome|ADV-TDF|In first double-blinded treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049478|NCT01300234|OG000|Outcome|TDF-TDF|In first double-blinded treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks.In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049479|NCT01300234|OG001|Outcome|ADV-TDF|In first double-blinded treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks.In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049480|NCT01300234|EG000|Reported Event|TDF-TDF|In first double-blinded treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049481|NCT01300234|EG001|Reported Event|ADV-TDF|In first double-blinded treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks.
11049482|NCT01300247|BG000|Baseline|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
11049483|NCT01300247|BG001|Baseline|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
11049484|NCT01300247|BG002|Baseline|Total|Total of all reporting groups
11049485|NCT01300247|FG000|Participant Flow|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 milligrams [mg] intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 milligrams per meter square [mg/m^2] IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
11049486|NCT01300247|FG001|Participant Flow|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
11049487|NCT01300247|OG000|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
11049488|NCT01300247|OG001|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
11049489|NCT01300247|EG000|Reported Event|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
11049490|NCT01300247|EG001|Reported Event|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
11049491|NCT01300260|BG000|Baseline|Healthy Participants|Includes healthy participants randomized to receive 1.5 milligram (mg) LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
11049492|NCT01300260|BG001|Baseline|Participants With Type 2 Diabetes Mellitus (T2DM)|Includes participants with T2DM randomized to receive 1.5 mg LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
11049493|NCT01300260|BG002|Baseline|Total|Total of all reporting groups
11049494|NCT01300260|FG000|Participant Flow|LY2189265 First, Then Placebo|"Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2.~On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.~There was a washout period of ≥28 days between Periods 1 & 2."
11049495|NCT01300260|FG001|Participant Flow|Placebo First, Then LY2189265|"Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2.~On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.~There was a washout period of ≥28 days between Periods 1 & 2."
11049496|NCT01300260|OG000|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
11049497|NCT01300260|OG001|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
11049498|NCT01300260|OG002|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
11049499|NCT01300260|OG003|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
11049500|NCT01300260|OG002|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes)
11049501|NCT01300260|OG000|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
11049502|NCT01300260|OG001|Outcome|Healthy Participants: LY2189265|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
11049503|NCT01300260|OG002|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
11049504|NCT01300260|OG003|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
11049505|NCT01300260|OG000|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered
11049506|NCT01300260|OG001|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
11049507|NCT01300260|EG000|Reported Event|Healthy Participants: Placebo|Healthy participants who received at least 1 subcutaneous injection of Placebo
11049508|NCT01300260|EG001|Reported Event|Healthy Participants: LY2189265|Healthy participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
11049509|NCT01300260|EG002|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants who received at least 1 subcutaneous injection of Placebo
11049510|NCT01300260|EG003|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
10846986|NCT00281580|BG008|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
11049511|NCT01300286|BG000|Baseline|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously
11049512|NCT01300286|FG000|Participant Flow|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
11049513|NCT01300286|OG000|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
11049514|NCT01300286|OG000|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
11049515|NCT01300286|EG000|Reported Event|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
11049516|NCT01300338|BG000|Baseline|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
11049517|NCT01300338|BG001|Baseline|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
11049518|NCT01300338|BG002|Baseline|Total|Total of all reporting groups
11049519|NCT01300338|FG000|Participant Flow|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
10846987|NCT00281580|BG009|Baseline|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
11049520|NCT01300338|FG001|Participant Flow|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry."
11049521|NCT01300338|OG000|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
11049522|NCT01300338|OG001|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
11049523|NCT01300338|EG000|Reported Event|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
11049524|NCT01300338|EG001|Reported Event|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
11049525|NCT01300351|BG000|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
11049526|NCT01300351|BG001|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
11049527|NCT01300351|BG002|Baseline|Total|Total of all reporting groups
11049528|NCT01300351|FG000|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
11049529|NCT01300351|FG001|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
11049530|NCT01300351|OG000|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
11049531|NCT01300351|OG001|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
11049532|NCT01300351|EG000|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
11049533|NCT01300351|EG001|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
11049534|NCT01300455|BG000|Baseline|Suvorexant (40 mg) Then Placebo|In Period 1, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
11049535|NCT01300455|BG001|Baseline|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
11049536|NCT01300455|BG002|Baseline|Total|Total of all reporting groups
11049537|NCT01300455|FG000|Participant Flow|Suvorexant (40 mg) Then Placebo|In Period 1, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
11049538|NCT01300455|FG001|Participant Flow|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
11049539|NCT01300455|OG000|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
11049540|NCT01300455|OG001|Outcome|Placebo|Participants administered placebo.
11049541|NCT01300455|EG000|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
11049542|NCT01300455|EG001|Reported Event|Placebo|Participants administered placebo.
11049543|NCT01300546|BG000|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
11049544|NCT01300546|BG001|Baseline|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
11049545|NCT01300546|BG002|Baseline|Total|Total of all reporting groups
11049546|NCT01300546|FG000|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
11049547|NCT01300546|FG001|Participant Flow|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
11049548|NCT01300546|OG000|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
11049549|NCT01300546|OG001|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
11049550|NCT01300546|EG000|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
11049551|NCT01300546|EG001|Reported Event|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
11049552|NCT01300559|BG000|Baseline|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
11049553|NCT01300559|BG001|Baseline|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
11049554|NCT01300559|BG002|Baseline|Total|Total of all reporting groups
11049555|NCT01300559|FG000|Participant Flow|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
11049556|NCT01300559|FG001|Participant Flow|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
11049557|NCT01300559|OG000|Outcome|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
11049558|NCT01300559|OG001|Outcome|No Treatment Group|Unipolar electrocautery without Tissuelink device will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
11049559|NCT01300559|EG000|Reported Event|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
11049560|NCT01300559|EG001|Reported Event|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
11049561|NCT01300572|BG000|Baseline|Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)|Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with ~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
11049562|NCT01300572|FG000|Participant Flow|Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)|"PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.~GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)"
11049563|NCT01300572|OG000|Outcome|Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)|Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with ~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
11049564|NCT01300572|OG000|Outcome|Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)|"PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.~GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)"
11049565|NCT01300572|EG000|Reported Event|Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)|PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
11349000|NCT04132336|OG000|Outcome|Naproxen Sodium/Caffeine-Dose 1|Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
11049566|NCT01300624|BG000|Baseline|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
11049567|NCT01300624|FG000|Participant Flow|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
11049568|NCT01300624|OG000|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
11049569|NCT01300624|OG000|Outcome|Verb Network Strengthening Treatment|"Verb Network Strengthening Treatment (VNeST) tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced.~Verb Network Strengthening Treatment: Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke."
11049570|NCT01300624|EG000|Reported Event|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
11049571|NCT01300650|BG000|Baseline|Anakinra|
11049572|NCT01300650|FG000|Participant Flow|Anakinra|Anakinra 100 mg subcutaneous daily injection
11049573|NCT01300650|OG000|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
11226488|NCT02375698|BG000|Baseline|H56:IC31 5/500|"5ug H56 + 500 ug IC31~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c)."
11226489|NCT02375698|BG001|Baseline|Placebo|The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
11049574|NCT01300650|OG000|Outcome|Anakinra|Anakinra 100 mg subcutaneous injection
11049575|NCT01300650|EG000|Reported Event|Anakinra|
11049576|NCT01300728|BG000|Baseline|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
11049577|NCT01300728|BG001|Baseline|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
11049578|NCT01300728|BG002|Baseline|Total|Total of all reporting groups
11049579|NCT01300728|FG000|Participant Flow|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
11049580|NCT01300728|FG001|Participant Flow|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
11049581|NCT01300728|OG000|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
11049582|NCT01300728|OG001|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
11049583|NCT01300728|EG000|Reported Event|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
11226490|NCT02375698|BG002|Baseline|Total|Total of all reporting groups
11349001|NCT04132336|OG001|Outcome|Naproxen Sodium/Caffeine-Dose 2|Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
11049584|NCT01300728|EG001|Reported Event|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
11049585|NCT01300741|BG000|Baseline|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
11049586|NCT01300741|FG000|Participant Flow|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
11049587|NCT01300741|OG000|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
11049588|NCT01300741|OG001|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
11049589|NCT01300741|EG000|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
11049590|NCT01300741|EG001|Reported Event|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
11049591|NCT01300767|BG000|Baseline|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
11049592|NCT01300767|FG000|Participant Flow|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
11049593|NCT01300767|OG000|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
11049594|NCT01300767|OG001|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
11049595|NCT01300767|EG000|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
11226491|NCT02375698|FG000|Participant Flow|H56:IC31 5/500|"5ug H56 + 500 ug IC31~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c)."
10846988|NCT00281580|BG010|Baseline|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
11049596|NCT01300767|EG001|Reported Event|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
11049597|NCT01300819|BG000|Baseline|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
11049598|NCT01300819|BG001|Baseline|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
11049599|NCT01300819|BG002|Baseline|Total|Total of all reporting groups
11049600|NCT01300819|FG000|Participant Flow|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
11049601|NCT01300819|FG001|Participant Flow|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
11049602|NCT01300819|OG000|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
11226492|NCT02375698|FG001|Participant Flow|Placebo|The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
11226493|NCT02375698|OG000|Outcome|H56:IC31 5/500|"5ug H56 + 500 ug IC31~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c)."
11049603|NCT01300819|OG001|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
11049604|NCT01300819|EG000|Reported Event|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
11049605|NCT01300819|EG001|Reported Event|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
11049606|NCT01300923|BG000|Baseline|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
11049607|NCT01300923|FG000|Participant Flow|Acamprosate|"The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.~Acamprosate"
11049608|NCT01300923|FG001|Participant Flow|Autism Spectrum Disorder (ADS)|This baseline comparison group will participated in only and biomarker portion of subject characterization.
11049609|NCT01300923|OG000|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day).
11049610|NCT01300923|OG000|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
11049611|NCT01300923|EG000|Reported Event|Acamprosate|The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.
11049612|NCT01300949|BG000|Baseline|Glaucoma|154 glaucoma, ocular hypertension and glaucoma suspect patients
11049613|NCT01300949|BG001|Baseline|Controls|125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).
11226494|NCT02375698|OG001|Outcome|Placebo|The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
11226495|NCT02375698|EG000|Reported Event|Gr 1 H56:IC31 5/500|"5ug H56 + 500 ug IC31~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c)."
11049614|NCT01300949|BG002|Baseline|Age-Related Macular Degeneration (ARMD)|35 retina patients with age-related macular degeneration (ARMD)
11049615|NCT01300949|BG003|Baseline|Total|Total of all reporting groups
11049616|NCT01300949|FG000|Participant Flow|Glaucoma|154 glaucoma, ocular hypertension and glaucoma suspect patients
11049617|NCT01300949|FG001|Participant Flow|Controls|125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).
11049618|NCT01300949|FG002|Participant Flow|Age-Related Macular Degeneration (ARMD)|35 retina patients with age-related macular degeneration (ARMD)
11049619|NCT01300949|OG000|Outcome|Glaucoma|"154 glaucoma, ocular hypertension and glaucoma suspect patients~Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes~Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background"
11049620|NCT01300949|OG001|Outcome|Controls|"125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).~Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes~Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background"
11049621|NCT01300949|OG002|Outcome|Age-Related Macular Degeneration (ARMD)|"35 retina patients with age-related macular degeneration (ARMD)~Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes~Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background"
11049622|NCT01300949|EG000|Reported Event|Glaucoma|154 glaucoma, ocular hypertension and glaucoma suspect patients
11049623|NCT01300949|EG001|Reported Event|Controls|125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).
11049624|NCT01300949|EG002|Reported Event|Age-Related Macular Degeneration (ARMD)|35 retina patients with age-related macular degeneration (ARMD)
11049625|NCT01301001|BG000|Baseline|All Study Participants|44 subjects were randomized to Placebo First and 45 subjects were randomized to Gabapentin First
11049626|NCT01301001|FG000|Participant Flow|Placebo First, Then Gabepentin|"Placebo capsule daily in first intervention period and Gabapentin capsule 3000 mg daily in in second intervention (after washout period)~Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm~Gabapentin: Gabapentin 1200 mg am and 1800 mg pm"
11049627|NCT01301001|FG001|Participant Flow|Gabapentin First, Then Placebo|"Gabapentin capsule 3000 mg daily in first intervention period and Placebo capsule in second intervention (after washout period)~Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm~Gabapentin: Gabapentin 1200 mg am and 1800 mg pm"
11049628|NCT01301001|OG000|Outcome|Placebo|2 capsules am and 3 capsules pm
11049629|NCT01301001|OG001|Outcome|Gabapentin|2 capsules (1200 mg) am and 3 capsules (1800 mg) pm
11226496|NCT02375698|EG001|Reported Event|Placebo|"The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.~Placebo: The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4."
11049630|NCT01301001|OG001|Outcome|Gabapentin|1200 mg am and 1800 mg pm
11049631|NCT01301001|EG000|Reported Event|Placebo|2 capsules am and 3 capsules pm
11049632|NCT01301001|EG001|Reported Event|Gabapentin|2 capsules (1200 mg) am and 3 capsules (1800) mg pm
11049633|NCT01301027|BG000|Baseline|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
11049634|NCT01301027|BG001|Baseline|Placebo|Placebo: 1 pill a day for 26 weeks
11049635|NCT01301027|BG002|Baseline|Total|Total of all reporting groups
11049636|NCT01301027|FG000|Participant Flow|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
11049637|NCT01301027|FG001|Participant Flow|Placebo|Placebo: 1 pill a day for 26 weeks
11049638|NCT01301027|OG000|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
11049639|NCT01301027|OG001|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
11049640|NCT01301027|EG000|Reported Event|Pioglitazone|"15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks~Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks"
11049641|NCT01301027|EG001|Reported Event|Placebo|"1 placebo pill a day matching the pioglitazone treatment for 26 weeks~Placebo: 1 pill a day for 26 weeks"
11049642|NCT01301066|BG000|Baseline|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
11049643|NCT01301066|BG001|Baseline|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
11049644|NCT01301066|BG002|Baseline|Total|Total of all reporting groups
11049645|NCT01301066|FG000|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
11049646|NCT01301066|FG001|Participant Flow|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
10846989|NCT00281580|BG011|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
11049647|NCT01301066|OG000|Outcome|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
11049648|NCT01301066|OG001|Outcome|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
11049649|NCT01301066|EG000|Reported Event|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
11049650|NCT01301066|EG001|Reported Event|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
11049651|NCT01301079|BG000|Baseline|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).~Ketamine : Patients in group ketamine will receive ketamine (5mcg/kg/min) during the surgery."
11049652|NCT01301079|BG001|Baseline|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. Patients in group 2 (G2) received remifentanil (0.4 μg/kg/min) and saline solution.~Saline : Patients in group N (placebo)will receive saline during surgery."
11049653|NCT01301079|BG002|Baseline|Total|Total of all reporting groups
11049654|NCT01301079|FG000|Participant Flow|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
11049655|NCT01301079|FG001|Participant Flow|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
11049656|NCT01301079|OG000|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
11049657|NCT01301079|OG001|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
11149181|NCT01869192|OG000|Outcome|Arm A|"Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment~Epirubicin: Epirubicin 90 mg/m2 d1 q3w~Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w~Radiation Therapy: Standard dosing, fields depending on clinical findings"
11049658|NCT01301079|OG000|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).~Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.~Ketamine: Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery."
11049659|NCT01301079|OG001|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution.~Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.~Saline: Patients in group N (placebo) was administrated saline during surgery."
11049660|NCT01301079|OG000|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
11049661|NCT01301079|OG000|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
11049662|NCT01301079|EG000|Reported Event|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and (ketamine 5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
11049663|NCT01301079|EG001|Reported Event|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
11049664|NCT01301092|BG000|Baseline|Part A: LY2189265 Intravenous|Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265
11049665|NCT01301092|BG001|Baseline|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
11049666|NCT01301092|BG002|Baseline|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
11049667|NCT01301092|BG003|Baseline|Total|Total of all reporting groups
11049668|NCT01301092|FG000|Participant Flow|Part A: LY2189265 Intravenous|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265.
11049669|NCT01301092|FG001|Participant Flow|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
11049670|NCT01301092|FG002|Participant Flow|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
11049671|NCT01301092|OG000|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
11049672|NCT01301092|OG001|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
11049673|NCT01301092|OG000|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5-milligram (mg) subcutaneous (SC) dose of LY2189265 in Period 1 or 2
11049674|NCT01301092|OG000|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1or 2
11049675|NCT01301092|OG001|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
11049676|NCT01301092|OG000|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1 or 2
11049677|NCT01301092|EG000|Reported Event|Part A: 0.1 mg IV LY2189265|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265
11049678|NCT01301092|EG001|Reported Event|Part B: 0.1 mg IV LY2189265|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2.
11049679|NCT01301092|EG002|Reported Event|Part B: 1.5 mg SC LY2189265|Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
11049680|NCT01301092|EG003|Reported Event|Part C: 0.75 mg IM LY2189265|Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2.
11049681|NCT01301092|EG004|Reported Event|Part C: 0.75 mg SC LY2189265|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
11049682|NCT01301183|BG000|Baseline|Rh IGF-1 + Transdermal Estradiol|"RhIGF-1 with transdermal 17-beta estradiol~RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.~Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
11049683|NCT01301183|BG001|Baseline|Placebo + Transdermal Estradiol|"Placebo and transdermal 17-beta estradiol~Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.~Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
11049684|NCT01301183|BG002|Baseline|Total|Total of all reporting groups
11049685|NCT01301183|FG000|Participant Flow|Rh IGF-1 + Transdermal Estradiol|"RhIGF-1 with transdermal 17-beta estradiol~RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.~Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
11049686|NCT01301183|FG001|Participant Flow|Placebo + Transdermal Estradiol|"Placebo and transdermal 17-beta estradiol~Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.~Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
11049687|NCT01301183|OG000|Outcome|Rh IGF-1 + Transdermal Estradiol|"RhIGF-1 with transdermal 17-beta estradiol~RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.~Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
11049688|NCT01301183|OG001|Outcome|Placebo + Transdermal Estradiol|"Placebo and transdermal 17-beta estradiol~Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.~Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
11049689|NCT01301183|EG000|Reported Event|Rh IGF-1 + Transdermal Estradiol|"RhIGF-1 with transdermal 17-beta estradiol~RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.~Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
11049690|NCT01301183|EG001|Reported Event|Placebo + Transdermal Estradiol|"Placebo and transdermal 17-beta estradiol~Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.~Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
11066732|NCT01393743|OG000|Outcome|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator's discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
11066733|NCT01393743|OG000|Outcome|PGTC Seizures|The median percent change from the Pre-perampanel baseline in PGTC seizure frequency per 28 days by 13-week intervals through greater than or equal to Week 144.
11066734|NCT01393743|OG001|Outcome|All Seizures|The median percent change from the Pre-perampanel baseline in the seizure frequency per 28 days of all seizures by 13-week intervals through greater than or equal to Week 144.
11066735|NCT01393743|EG000|Reported Event|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
11066736|NCT01393743|EG001|Reported Event|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
11149182|NCT01869192|OG001|Outcome|Arm B|"Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment~Docetaxel: Docetaxel 75 mg/m2 d1 q3w~Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w~Radiation Therapy: Standard dosing, fields depending on clinical findings"
11049691|NCT01301274|BG000|Baseline|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
11049692|NCT01301274|BG001|Baseline|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
11049693|NCT01301274|BG002|Baseline|Total|Total of all reporting groups
11049694|NCT01301274|FG000|Participant Flow|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
11049695|NCT01301274|FG001|Participant Flow|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
11049696|NCT01301274|OG000|Outcome|Hypotonic Arm|patients who received for maintenance solution 0.45% ClNa in Dx 5%
11049697|NCT01301274|OG001|Outcome|Isotonic Arm|Patients who received for maintenance solution 0.9% ClNa in Dx 5%
11049698|NCT01301274|OG000|Outcome|Hypotonic Arm|patients who received maintenance solution 0.45% ClNa in Dx 5%
11049699|NCT01301274|OG001|Outcome|Isotonic Arm|patients who received maintenance solution 0.9% ClNa in Dx 5%
11049700|NCT01301274|OG000|Outcome|Hypotonic Arm|patients who received fro maintenance solution ClNa 0.45% in Dx 5%
11049701|NCT01301274|OG001|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
11049702|NCT01301274|OG000|Outcome|Hypotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
11349002|NCT04132336|OG002|Outcome|Naproxen Sodium/Caffeine-Dose 3|Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
11049703|NCT01301274|EG000|Reported Event|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
11049704|NCT01301274|EG001|Reported Event|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
11049705|NCT01301391|BG000|Baseline|Milciclib|"Milciclib Maleate capsules~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
11049706|NCT01301391|FG000|Participant Flow|Milciclib|"Milciclib Maleate capsules~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
11049707|NCT01301391|OG000|Outcome|Milciclib|"Milciclib Maleate capsules~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
11049708|NCT01301391|EG000|Reported Event|Milciclib|"Milciclib Maleate capsules~Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.~Number of cycles: until disease progression or unacceptable toxicity."
11049709|NCT01301456|BG000|Baseline|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
11049710|NCT01301456|BG001|Baseline|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
11049711|NCT01301456|BG002|Baseline|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
11049712|NCT01301456|BG003|Baseline|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
11049713|NCT01301456|BG004|Baseline|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
11049714|NCT01301456|BG005|Baseline|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
11049715|NCT01301456|BG006|Baseline|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
11049716|NCT01301456|BG007|Baseline|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049717|NCT01301456|BG008|Baseline|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049718|NCT01301456|BG009|Baseline|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049719|NCT01301456|BG010|Baseline|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049720|NCT01301456|BG011|Baseline|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049721|NCT01301456|BG012|Baseline|Total|Total of all reporting groups
11049722|NCT01301456|FG000|Participant Flow|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
11049723|NCT01301456|FG001|Participant Flow|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.
11049724|NCT01301456|FG002|Participant Flow|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
11049725|NCT01301456|FG003|Participant Flow|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
11049726|NCT01301456|FG004|Participant Flow|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
11049727|NCT01301456|FG005|Participant Flow|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
11049728|NCT01301456|FG006|Participant Flow|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
11049729|NCT01301456|FG007|Participant Flow|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049730|NCT01301456|FG008|Participant Flow|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049731|NCT01301456|FG009|Participant Flow|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049732|NCT01301456|FG010|Participant Flow|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049733|NCT01301456|FG011|Participant Flow|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049734|NCT01301456|OG000|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
11049735|NCT01301456|OG001|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
11049736|NCT01301456|OG002|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
11049737|NCT01301456|OG003|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
11049738|NCT01301456|OG004|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
11049739|NCT01301456|OG005|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
11049740|NCT01301456|OG006|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
11049741|NCT01301456|OG007|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049742|NCT01301456|OG008|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049743|NCT01301456|OG009|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049744|NCT01301456|OG010|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049745|NCT01301456|OG011|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049746|NCT01301456|OG006|Outcome|Stage 1: PF-04856883 36mg Single Dose|Participants received subcutaneous injection of PF-04856883 4 mg by a 4-week follow up period in Stage 1
11049747|NCT01301456|OG000|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
11049748|NCT01301456|OG001|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
11049749|NCT01301456|OG002|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
11049750|NCT01301456|OG003|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
11049751|NCT01301456|OG004|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
10846990|NCT00281580|BG012|Baseline|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
11049752|NCT01301456|OG005|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
11049753|NCT01301456|OG000|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049754|NCT01301456|OG001|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049755|NCT01301456|OG002|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049756|NCT01301456|OG003|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049757|NCT01301456|OG000|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049758|NCT01301456|OG001|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049759|NCT01301456|OG002|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049760|NCT01301456|OG003|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049761|NCT01301456|OG004|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049762|NCT01301456|OG006|Outcome|Stage 2: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
11049763|NCT01301456|OG005|Outcome|Stage 1: PF-04856883 24mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
11049764|NCT01301456|EG000|Reported Event|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
11049765|NCT01301456|EG001|Reported Event|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.
10846991|NCT00281580|BG013|Baseline|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
11049766|NCT01301456|EG002|Reported Event|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
11049767|NCT01301456|EG003|Reported Event|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
11049768|NCT01301456|EG004|Reported Event|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
11049769|NCT01301456|EG005|Reported Event|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
11049770|NCT01301456|EG006|Reported Event|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
11049771|NCT01301456|EG007|Reported Event|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049772|NCT01301456|EG008|Reported Event|Stage 2: PF-04856883 12.0 mg|Participants received single dose of PF-04856883 12.0 mg subcutaneous injection on Day 1, 8, 15 and 22 in Stage 2.
11049773|NCT01301456|EG009|Reported Event|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049774|NCT01301456|EG010|Reported Event|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049775|NCT01301456|EG011|Reported Event|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
11049776|NCT01301508|BG000|Baseline|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
11049777|NCT01301508|BG001|Baseline|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
11049778|NCT01301508|BG002|Baseline|Total|Total of all reporting groups
11049779|NCT01301508|FG000|Participant Flow|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate atopic dermatitis (AD) applied AN2898 ointment, 1 percent (%) to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
11049780|NCT01301508|FG001|Participant Flow|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
11049781|NCT01301508|OG000|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
11049782|NCT01301508|OG001|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
11049783|NCT01301508|EG000|Reported Event|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
11049784|NCT01301508|EG001|Reported Event|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
11049785|NCT01301625|BG000|Baseline|MitraClip Implant|"Eligible patients undergoing a MitraClip procedure in Australia and New Zealand~MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant."
11049786|NCT01301625|FG000|Participant Flow|MitraClip Implant|"Eligible patients undergoing a MitraClip procedure in Australia and New Zealand~MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant."
11049787|NCT01301625|OG000|Outcome|MitraClip Implant|"Eligible patients undergoing a MitraClip procedure in Australia and New Zealand~MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant."
11049788|NCT01301625|EG000|Reported Event|MitraClip Implant|"Eligible patients undergoing a MitraClip procedure in Australia and New Zealand~MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant."
11049789|NCT01301729|BG000|Baseline|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
11049790|NCT01301729|FG000|Participant Flow|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
11226497|NCT02375724|BG000|Baseline|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
11226498|NCT02375724|BG001|Baseline|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
11226499|NCT02375724|BG002|Baseline|Total|Total of all reporting groups
11049791|NCT01301729|OG000|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
11049792|NCT01301729|OG000|Outcome|Tastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
11049793|NCT01301729|EG000|Reported Event|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
11049794|NCT01301742|BG000|Baseline|Entire Study Population|"The two treatments given in a randomised order were:~Empagliflozin 25mg (Empa) was given as a single dose on Day 1~Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empa was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.~Between treatments there was a washout period of at least 7 days."
11049795|NCT01301742|FG000|Participant Flow|Empa First, Then Empa and Gemfibrozil|Empagliflozin 25mg (Empa) was given as a single dose on Day 1, followed by a washout period of at least 7 days, followed by Gemfibrozil 600mg given twice daily for 5 days starting on day -2 and empa given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
11049796|NCT01301742|FG001|Participant Flow|Empa and Gemfibrozil First, Then Empa|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. This was followed by a washout period of at least 7 days, followed by Empa given as a single dose on Day 1.
11049797|NCT01301742|OG000|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
11049798|NCT01301742|OG001|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
11049799|NCT01301742|EG000|Reported Event|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
11049800|NCT01301742|EG001|Reported Event|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
11049801|NCT01301742|EG002|Reported Event|Gemfibrozil Alone|Between the first gemfibrozil administration and the empagliflozin administration, for the Empa and gemfibrozil treatment period.
11049802|NCT01301833|BG000|Baseline|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
11049803|NCT01301833|BG001|Baseline|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
11049804|NCT01301833|BG002|Baseline|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
11049805|NCT01301833|BG003|Baseline|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
11049806|NCT01301833|BG004|Baseline|Total|Total of all reporting groups
11049807|NCT01301833|FG000|Participant Flow|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
11049808|NCT01301833|FG001|Participant Flow|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
11049809|NCT01301833|FG002|Participant Flow|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
11049810|NCT01301833|FG003|Participant Flow|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
11049811|NCT01301833|OG000|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
11049812|NCT01301833|OG001|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
10846992|NCT00281580|BG014|Baseline|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
11049813|NCT01301833|OG002|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
11049814|NCT01301833|OG003|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
11049815|NCT01301833|EG000|Reported Event|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
11049816|NCT01301833|EG001|Reported Event|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
11049817|NCT01301833|EG002|Reported Event|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
11049818|NCT01301833|EG003|Reported Event|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
11226500|NCT02375724|FG000|Participant Flow|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
11226501|NCT02375724|FG001|Participant Flow|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
11226502|NCT02375724|OG000|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
11226503|NCT02375724|OG001|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
11226504|NCT02375724|EG000|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
11226505|NCT02375724|EG001|Reported Event|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
11049819|NCT01301950|BG000|Baseline|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
11049820|NCT01301950|BG001|Baseline|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
11049821|NCT01301950|BG002|Baseline|Total|Total of all reporting groups
11049822|NCT01301950|FG000|Participant Flow|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
11049823|NCT01301950|FG001|Participant Flow|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
11049824|NCT01301950|OG000|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
11049825|NCT01301950|OG001|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
11049826|NCT01301950|EG000|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions Instrument: TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
11049827|NCT01301950|EG001|Reported Event|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
11049828|NCT01302041|BG000|Baseline|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
11049829|NCT01302041|FG000|Participant Flow|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
11049830|NCT01302041|OG000|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
11049831|NCT01302041|OG000|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
11049832|NCT01302041|EG000|Reported Event|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
11049833|NCT01302054|BG000|Baseline|Entire Study Population|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had <= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
11049834|NCT01302054|FG000|Participant Flow|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
11049835|NCT01302054|FG001|Participant Flow|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
11049836|NCT01302054|FG002|Participant Flow|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
10846993|NCT00281580|BG015|Baseline|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
11049837|NCT01302054|OG000|Outcome|Fesoterodine: Double-Blind Baseline|Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
11049838|NCT01302054|OG001|Outcome|Fesoterodine: Double-Blind Week 12|Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
11049839|NCT01302054|OG000|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
11049840|NCT01302054|OG001|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
11049841|NCT01302054|EG000|Reported Event|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
11049842|NCT01302054|EG001|Reported Event|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
11049843|NCT01302054|EG002|Reported Event|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
11049844|NCT01302067|BG000|Baseline|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
11049845|NCT01302067|BG001|Baseline|Placebo|Participants received one tablet of placebo per day for 12 weeks.
11049846|NCT01302067|BG002|Baseline|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
11049847|NCT01302067|BG003|Baseline|Total|Total of all reporting groups
11049848|NCT01302067|FG000|Participant Flow|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
11049849|NCT01302067|FG001|Participant Flow|Placebo|Participants received one tablet of placebo per day for 12 weeks.
11049850|NCT01302067|FG002|Participant Flow|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
11049851|NCT01302067|OG000|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
11049852|NCT01302067|OG001|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
11049853|NCT01302067|OG002|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
11049854|NCT01302067|EG000|Reported Event|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
11049855|NCT01302067|EG001|Reported Event|Placebo|Participants received one tablet of placebo per day for 12 weeks.
11049856|NCT01302067|EG002|Reported Event|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
11049857|NCT01302080|BG000|Baseline|Sertraline|Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.
11049858|NCT01302080|BG001|Baseline|Other Antidepressant|Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.
11049859|NCT01302080|BG002|Baseline|Psychotherapy|Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.
11049860|NCT01302080|BG003|Baseline|Total|Total of all reporting groups
11049861|NCT01302080|FG000|Participant Flow|Sertraline|Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to United States prescribing information (USPI) provided by their physician. Participants in this group were on sertraline only or sertraline and any other treatment. Treatment here was the one which was planned for the participants at baseline.
11049862|NCT01302080|FG001|Participant Flow|Psychotherapy|Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial/psychotherapy rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a selective serotonin reuptake inhibitor (SSRI) medication. Participants in this group were on psychotherapy only or no treatment at all.
11049863|NCT01302080|OG000|Outcome|Sertraline|"At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.~At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit."
11049864|NCT01302080|OG001|Outcome|Other Antidepressants|At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
11049865|NCT01302080|OG002|Outcome|Psychotherapy|At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
11049866|NCT01302080|OG000|Outcome|Sertraline|At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
11049867|NCT01302080|EG000|Reported Event|Sertraline (Baseline)|Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.
11049868|NCT01302080|EG001|Reported Event|Other Antidepressants (Baseline)|Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.
11049869|NCT01302080|EG002|Reported Event|Psychotherapy (Baseline)|Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.
11049870|NCT01302080|EG003|Reported Event|Sertraline (Month 3)|Participants in this group were on sertraline only or sertraline and any other treatment at Month 3 visit.
11049871|NCT01302080|EG004|Reported Event|Other Antidepressants (Month 3)|Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 3 visit.
11049872|NCT01302080|EG005|Reported Event|Psychotherapy (Month 3)|Participants in this group were on psychotherapy only or no treatment at all at Month 3 visit.
11049873|NCT01302080|EG006|Reported Event|Sertraline (Month 6)|Participants in this group were on sertraline only or sertraline and any other treatment at Month 6 visit.
11049874|NCT01302080|EG007|Reported Event|Other Antidepressants (Month 6)|Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 6 visit.
11049875|NCT01302080|EG008|Reported Event|Psychotherapy (Month 6)|Participants in this group were on psychotherapy only or no treatment at all at Month 6 visit.
11049876|NCT01302080|EG009|Reported Event|Sertraline (Month 12)|Participants in this group were on sertraline only or sertraline and any other treatment at Month 12 visit.
11049877|NCT01302080|EG010|Reported Event|Other Antidepressants (Month 12)|Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 12 visit.
11049878|NCT01302080|EG011|Reported Event|Psychotherapy (Month 12)|Participants in this group were on psychotherapy only or no treatment at all at Month 12 visit.
11049879|NCT01302080|EG012|Reported Event|Sertraline (Month 18)|Participants in this group were on sertraline only or sertraline and any other treatment at Month 18 visit.
11049880|NCT01302080|EG013|Reported Event|Other Antidepressants (Month 18)|Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 18 visit.
11049881|NCT01302080|EG014|Reported Event|Psychotherapy (Month 18)|Participants in this group were on psychotherapy only or no treatment at all at Month 18 visit.
11049882|NCT01302080|EG015|Reported Event|Sertraline (Month 24)|Participants in this group were on sertraline only or sertraline and any other treatment at Month 24 visit.
11049883|NCT01302080|EG016|Reported Event|Other Antidepressants (Month 24)|Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 24 visit.
11049884|NCT01302080|EG017|Reported Event|Psychotherapy (Month 24)|Participants in this group were on psychotherapy only or no treatment at all at Month 24 visit.
11049885|NCT01302080|EG018|Reported Event|Sertraline (Month 30)|Participants in this group were on sertraline only or sertraline and any other treatment at Month 30 visit.
11049886|NCT01302080|EG019|Reported Event|Other Antidepressants (Month 30)|Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 30 visit.
11049887|NCT01302080|EG020|Reported Event|Psychotherapy (Month 30)|Participants in this group were on psychotherapy only or no treatment at all at Month 30 visit.
11049888|NCT01302080|EG021|Reported Event|Sertraline (Month 36)|Participants in this group were on sertraline only or sertraline and any other treatment at Month 36 visit.
11049889|NCT01302080|EG022|Reported Event|Other Antidepressants (Month 36)|Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 36 visit.
10846994|NCT00281580|BG016|Baseline|Total|Total of all reporting groups
11049890|NCT01302080|EG023|Reported Event|Psychotherapy (Month 36)|Participants in this group were on psychotherapy only or no treatment at all at Month 36 visit.
11049891|NCT01302119|BG000|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
11049892|NCT01302119|BG001|Baseline|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
11049893|NCT01302119|BG002|Baseline|Total|Total of all reporting groups
11049894|NCT01302119|FG000|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
11049895|NCT01302119|FG001|Participant Flow|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
11049896|NCT01302119|OG000|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
11049897|NCT01302119|OG001|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
11049898|NCT01302119|EG000|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
11049899|NCT01302119|EG001|Reported Event|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
11049900|NCT01302366|BG000|Baseline|Sea Cucumber Extract (TBL 12)|"TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.~TBL-12"
11049901|NCT01302366|FG000|Participant Flow|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
11049902|NCT01302366|OG000|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
11049903|NCT01302366|EG000|Reported Event|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
11049904|NCT01302379|BG000|Baseline|Metformin + Lifestyle Intervention|"Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time~Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss."
11049905|NCT01302379|BG001|Baseline|Placebo + Lifestyle Intervention|"Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time~Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss."
11049906|NCT01302379|BG002|Baseline|Metformin + Standard Dietary Guidelines|"Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time~Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)"
11049907|NCT01302379|BG003|Baseline|Placebo + Standard Dietary Guidelines|"Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time~Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)"
11049908|NCT01302379|BG004|Baseline|Total|Total of all reporting groups
11049909|NCT01302379|FG000|Participant Flow|Metformin + Lifestyle Intervention|"Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time~Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss."
11049910|NCT01302379|FG001|Participant Flow|Placebo + Lifestyle Intervention|"Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time~Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss."
11049911|NCT01302379|FG002|Participant Flow|Metformin + Standard Dietary Guidelines|"Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time~Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)"
11049912|NCT01302379|FG003|Participant Flow|Placebo + Standard Dietary Guidelines|"Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time~Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)"
11049913|NCT01302379|OG000|Outcome|Metformin + Lifestyle Intervention|"Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time~Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss."
11049914|NCT01302379|OG001|Outcome|Placebo + Lifestyle Intervention|"Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time~Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss."
11049915|NCT01302379|OG002|Outcome|Metformin + Standard Dietary Guidelines|"Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time~Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)"
10846995|NCT00281580|FG000|Participant Flow|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
11049916|NCT01302379|OG003|Outcome|Placebo + Standard Dietary Guidelines|"Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time~Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)"
11049917|NCT01302379|EG000|Reported Event|Metformin vs Placebo|Main effect for Metformin vs Placebo
11049918|NCT01302379|EG001|Reported Event|Lifestyle vs. Control|Main effect for the lifestyle intervention vs control intervention
11049919|NCT01302392|BG000|Baseline|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle)."
11049920|NCT01302392|BG001|Baseline|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
11049921|NCT01302392|BG002|Baseline|Total|Total of all reporting groups
11049922|NCT01302392|FG000|Participant Flow|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle)."
11049923|NCT01302392|FG001|Participant Flow|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
11049924|NCT01302392|OG000|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle)."
11226506|NCT02375971|BG000|Baseline|Ranibizumab 0.2 mg|1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
11049925|NCT01302392|OG001|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
11049926|NCT01302392|EG000|Reported Event|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle)."
11049927|NCT01302392|EG001|Reported Event|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
11049928|NCT01302418|BG000|Baseline|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
11049929|NCT01302418|FG000|Participant Flow|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
11049930|NCT01302418|OG000|Outcome|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
11049931|NCT01302418|EG000|Reported Event|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
11049932|NCT01302483|BG000|Baseline|Kovacaine Nasal Spray|
11049933|NCT01302483|BG001|Baseline|Lidocaine Injection|
11049934|NCT01302483|BG002|Baseline|Total|Total of all reporting groups
11049935|NCT01302483|FG000|Participant Flow|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
11049936|NCT01302483|FG001|Participant Flow|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
11049937|NCT01302483|OG000|Outcome|Kovacaine Nasal Spray|Number of subjects able to complete the dental procedure without rescue
11049938|NCT01302483|OG001|Outcome|Lidocaine Injection|Number of subjects able to complete the dental procedure without rescue
11049939|NCT01302483|OG000|Outcome|Kovacaine Nasal Spray|Duration of Soft Tissue Anesthesia
11349003|NCT04132336|OG003|Outcome|Naproxen Sodium/Caffeine-Dose 4|Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
11049940|NCT01302483|OG001|Outcome|Lidocaine Injection|Duration of Soft Tissue Anesthesia
11049941|NCT01302483|OG000|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
11049942|NCT01302483|OG001|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
11049943|NCT01302483|OG000|Outcome|Kovacaine Nasal Spray|Blood Pressure Maximum Change from Baseline
11049944|NCT01302483|OG001|Outcome|Lidocaine Injection|Blood Pressure Maximum Change from Baseline
11049945|NCT01302483|EG000|Reported Event|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
11049946|NCT01302483|EG001|Reported Event|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
11049947|NCT01302548|BG000|Baseline|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
11049948|NCT01302548|BG001|Baseline|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
11049949|NCT01302548|BG002|Baseline|Total|Total of all reporting groups
11049950|NCT01302548|FG000|Participant Flow|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
11049951|NCT01302548|FG001|Participant Flow|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
11049952|NCT01302548|OG000|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
11049953|NCT01302548|OG001|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
11049954|NCT01302548|EG000|Reported Event|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
11049955|NCT01302548|EG001|Reported Event|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
11049956|NCT01302691|BG000|Baseline|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
11049957|NCT01302691|BG001|Baseline|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
11049958|NCT01302691|BG002|Baseline|Total|Total of all reporting groups
11049959|NCT01302691|FG000|Participant Flow|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
11049960|NCT01302691|FG001|Participant Flow|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
11049961|NCT01302691|OG000|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
11049962|NCT01302691|OG001|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
11049963|NCT01302691|EG000|Reported Event|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
11349004|NCT04132336|OG004|Outcome|Naproxen Sodium|Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
11049964|NCT01302691|EG001|Reported Event|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
11049965|NCT01302743|BG000|Baseline|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
11049966|NCT01302743|BG001|Baseline|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
11049967|NCT01302743|BG002|Baseline|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
11049968|NCT01302743|BG003|Baseline|Total|Total of all reporting groups
11049969|NCT01302743|FG000|Participant Flow|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
11049970|NCT01302743|FG001|Participant Flow|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
11049971|NCT01302743|FG002|Participant Flow|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
11049972|NCT01302743|OG000|Outcome|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
11049973|NCT01302743|OG001|Outcome|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
10846996|NCT00281580|FG001|Participant Flow|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
11049974|NCT01302743|OG002|Outcome|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
11049975|NCT01302743|EG000|Reported Event|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
11049976|NCT01302743|EG001|Reported Event|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
11049977|NCT01302743|EG002|Reported Event|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
11049978|NCT01302808|BG000|Baseline|Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))|Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049979|NCT01302808|BG001|Baseline|Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049980|NCT01302808|BG002|Baseline|Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049981|NCT01302808|BG003|Baseline|Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis|Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049982|NCT01302808|BG004|Baseline|Total|Total of all reporting groups
11049983|NCT01302808|FG000|Participant Flow|Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))|Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049984|NCT01302808|FG001|Participant Flow|Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049985|NCT01302808|FG002|Participant Flow|Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049986|NCT01302808|FG003|Participant Flow|Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis|Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
10846997|NCT00281580|FG002|Participant Flow|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
10846998|NCT00281580|FG003|Participant Flow|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
10846999|NCT00281580|FG004|Participant Flow|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
11049987|NCT01302808|OG000|Outcome|Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))|Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049988|NCT01302808|OG001|Outcome|Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049989|NCT01302808|OG002|Outcome|Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049990|NCT01302808|OG003|Outcome|Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis|Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049991|NCT01302808|OG000|Outcome|Erlotinib Plus Romidepsin Cohort 1 (8mg/m2) + Cohort 4 (Modified Prophylaxis @ 8 mg/m2)|"Erlotinib 150 mg orally daily plus romidepsin IV days 1, 8, 15 (dose escalated) every 28 days~erlotinib~romidepsin"
11049992|NCT01302808|OG001|Outcome|Cohort 2 (10mg/m2) +Cohort 3 ( Modified Prophylaxis @ 10 mg/m2)|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle (cohort 2), with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle (cohort 3).
11049993|NCT01302808|EG000|Reported Event|Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))|Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049994|NCT01302808|EG001|Reported Event|Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049995|NCT01302808|EG002|Reported Event|Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis|Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11049996|NCT01302808|EG003|Reported Event|Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis|Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
11050006|NCT01302860|BG000|Baseline|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
11050007|NCT01302860|FG000|Participant Flow|Canakinumab|Participants received body weight stratified dose of canakinumab 2 milligrams/kilogram (mg/kg) subcutaneous (s.c.) injection every 8 weeks.
11050008|NCT01302860|OG000|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
11050009|NCT01302860|EG000|Reported Event|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
11050010|NCT01302899|BG000|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
11050011|NCT01302899|BG001|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
11050012|NCT01302899|BG002|Baseline|Total|Total of all reporting groups
11050013|NCT01302899|FG000|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
11050014|NCT01302899|FG001|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
11050015|NCT01302899|OG000|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
11050016|NCT01302899|OG001|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
11050017|NCT01302899|OG002|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
11050018|NCT01302899|OG003|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
11050019|NCT01302899|EG000|Reported Event|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
11050020|NCT01302899|EG001|Reported Event|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
11050021|NCT01302899|EG002|Reported Event|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
11050022|NCT01302899|EG003|Reported Event|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
11050023|NCT01302938|BG000|Baseline|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
11050024|NCT01302938|BG001|Baseline|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
11050025|NCT01302938|BG002|Baseline|Total|Total of all reporting groups
11050026|NCT01302938|FG000|Participant Flow|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
11050027|NCT01302938|FG001|Participant Flow|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
11050028|NCT01302938|OG000|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
11050029|NCT01302938|OG001|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
11050030|NCT01302938|OG000|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
11050031|NCT01302938|EG000|Reported Event|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
11050032|NCT01302938|EG001|Reported Event|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
11050033|NCT01302964|BG000|Baseline|Mirtazapine|"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.~Mirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subjects weighing less than 50 kg and up to 15 mg weekly for subjects weighing more than 50 kg depending upon efficacy and tolerability."
11050034|NCT01302964|BG001|Baseline|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo will receive placebo for duration of the study"
11050035|NCT01302964|BG002|Baseline|Total|Total of all reporting groups
11050036|NCT01302964|FG000|Participant Flow|Mirtazapine|"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.~Mirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subjects weighing less than 50 kg and up to 15 mg weekly for subjects weighing more than 50 kg depending upon efficacy and tolerability."
11050037|NCT01302964|FG001|Participant Flow|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo will receive placebo for duration of the study"
11050038|NCT01302964|OG000|Outcome|Mirtazapine|"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.~Mirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subject weighing less than 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability."
11050039|NCT01302964|OG001|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo will receive placebo for duration of the study"
11050040|NCT01302964|EG000|Reported Event|Mirtazapine|"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.~Mirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subject weighing less than 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability."
11050041|NCT01302964|EG001|Reported Event|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo will receive placebo for duration of the study"
11050042|NCT01303068|BG000|Baseline|CF Patients, 13C Urea Breath Test Kit|"CF patients with Pseudomonas infection tested with 13C urea breath test~13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas"
11050043|NCT01303068|BG001|Baseline|Healthy Controls, 13C Urea Breath Test Kit|"Healthy subjects using 13C urea breath test kit~13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas"
11050044|NCT01303068|BG002|Baseline|Total|Total of all reporting groups
11050045|NCT01303068|FG000|Participant Flow|CF Patients, 13C Urea Breath Test Kit|"CF patients with Pseudomonas infection tested with 13C urea breath test~13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas"
11050046|NCT01303068|FG001|Participant Flow|Healthy Subjects Using 13C Urea Breath Test Kit|"Healthy subjects using 13C urea breath test kit~13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas"
11050047|NCT01303068|OG000|Outcome|CF Patients, 13C Urea Breath Test Kit|"CF patients with Pseudomonas infection tested with 13C urea breath test~13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas"
11050048|NCT01303068|OG001|Outcome|Healthy Subjects Using 13C Urea Breath Test Kit|"Healthy subjects using 13C urea breath test kit~13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas"
11050049|NCT01303068|EG000|Reported Event|CF Patients, 13C Urea Breath Test Kit|"CF patients with Pseudomonas infection tested with 13C urea breath test~13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas"
11050050|NCT01303068|EG001|Reported Event|Healthy Subjects Using 13C Urea Breath Test Kit|"Healthy subjects using 13C urea breath test kit~13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas"
11050051|NCT01303159|BG000|Baseline|Radiofrequency Probe (ENDOHPB)|Intervention: The EndoHPB Radiofrequency probe
11050052|NCT01303159|FG000|Participant Flow|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
11050053|NCT01303159|OG000|Outcome|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
11050054|NCT01303159|EG000|Reported Event|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
11050055|NCT01303172|BG000|Baseline|Experimental|Gemcitabine plus IMM-101
11050056|NCT01303172|BG001|Baseline|Control|Gemcitabine monotherapy
11050057|NCT01303172|BG002|Baseline|Total|Total of all reporting groups
11050058|NCT01303172|FG000|Participant Flow|Gemcitabine Plus IMM-101|"Patients in the experimental arm received IMM-101 in addition to Gemcitabine (Gem). The treatment regimen with IMM-101 was every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter.~For patients in the experimental group, GEM was initiated at least 14 days after first dose of IMM-101.~GEM plus IMM-101 was offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks).~IMM-101: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.~A single 0.1 mL intradermal injection of IMM-101 (10 mg/mL)will be administered every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter.~Chemotherapy plus IMM-101 will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles of GEM.~Patients who completed the Main Study and who provided informed consent were eligible to participate in a long term treatment Sub-Study where all patients received IMM-101."
10847000|NCT00281580|FG005|Participant Flow|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
11050059|NCT01303172|FG001|Participant Flow|Gemcitabine Monotherapy|"Patients in the control arm received normal standard of care - up to 12 cycles of Gemcitabine. Dosing of Gemcitabine was as per the normal prescribing information for pancreatic cancer.~Gemcitabine was administered intravenously at 1000 mg/m2 over 30 minutes once weekly for 3 consecutive weeks out of every 4 weeks until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks).~Dosage reduction with each cycle or within each cycle was applied based upon the grade of Gemcitabine-related toxicity experienced by the patient using centre's standard protocol.~Patients who completed the Main Study and who provided informed consent were eligible to participate in a long term treatment Sub-Study where all patients received IMM-101."
11050060|NCT01303172|OG000|Outcome|Experimental|Gemcitabine plus IMM-101
11050061|NCT01303172|OG001|Outcome|Control|Gemcitabine monotherapy
11050062|NCT01303172|OG000|Outcome|Experimental|IMM-101 plus Gemcitabine
11050063|NCT01303172|EG000|Reported Event|Experimental|Gemcitabine plus IMM-101
11050064|NCT01303172|EG001|Reported Event|Control|Gemcitabine monotherapy
11050065|NCT01303224|BG000|Baseline|Ibodutant 1 mg|oral tablet, once daily
11050066|NCT01303224|BG001|Baseline|Ibodutant 3 mg|oral tablet, once daily
11050067|NCT01303224|BG002|Baseline|Ibodutant 10 mg|oral tablet, once daily
11050068|NCT01303224|BG003|Baseline|Placebo|oral tablet, once daily
11050069|NCT01303224|BG004|Baseline|Total|Total of all reporting groups
11050070|NCT01303224|FG000|Participant Flow|Ibodutant 1 mg|oral tablet, once daily
11050071|NCT01303224|FG001|Participant Flow|Ibodutant 3 mg|oral tablet, once daily
11050072|NCT01303224|FG002|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
11050073|NCT01303224|FG003|Participant Flow|Placebo|oral tablet, once daily
11050074|NCT01303224|OG000|Outcome|Ibodutant 1 mg|oral tablet, once daily
11050075|NCT01303224|OG001|Outcome|Ibodutant 3 mg|oral tablet, once daily
11050076|NCT01303224|OG002|Outcome|Ibodutant 10 mg|oral tablet, once daily
11050077|NCT01303224|OG003|Outcome|Placebo|oral tablet, once daily
11050078|NCT01303224|EG000|Reported Event|Ibodutant 1 mg|oral tablet, once daily
11050079|NCT01303224|EG001|Reported Event|Ibodutant 3 mg|oral tablet, once daily
11050080|NCT01303224|EG002|Reported Event|Ibodutant 10 mg|oral tablet, once daily
11050081|NCT01303224|EG003|Reported Event|Placebo|oral tablet, once daily
11050082|NCT01303380|BG000|Baseline|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
11226507|NCT02375971|BG001|Baseline|Ranibizumab 0.1 mg|1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
11226508|NCT02375971|BG002|Baseline|Laser Therapy|Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
11226509|NCT02375971|BG003|Baseline|Total|Total of all reporting groups
11050083|NCT01303380|FG000|Participant Flow|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new Hyper-IgD with periodic fever syndrome (HIDS) flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
11050084|NCT01303380|OG000|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
11050085|NCT01303380|EG000|Reported Event|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
11050086|NCT01303406|BG000|Baseline|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
11050087|NCT01303406|BG001|Baseline|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
11050088|NCT01303406|BG002|Baseline|Total|Total of all reporting groups
11050089|NCT01303406|FG000|Participant Flow|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
11050090|NCT01303406|FG001|Participant Flow|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
11050091|NCT01303406|OG000|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
11050092|NCT01303406|OG001|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
11050093|NCT01303406|EG000|Reported Event|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
11050094|NCT01303406|EG001|Reported Event|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
11226510|NCT02375971|FG000|Participant Flow|Ranibizumab 0.2 mg|1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
11050095|NCT01303419|BG000|Baseline|CE-BMRI and DE-CEDM Examinations|"Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.~CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance~DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography"
11050096|NCT01303419|FG000|Participant Flow|CE-BMRI and DE-CEDM Examinations|"Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.~CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance~DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography"
11050097|NCT01303419|OG000|Outcome|CE-BMRI and DE-CEDM Examinations|"Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.~CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance~DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography"
11050098|NCT01303419|EG000|Reported Event|CE-BMRI and DE-CEDM Examinations|"Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.~CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance~DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography"
11050099|NCT01303445|BG000|Baseline|Entire Study Population|
11050100|NCT01303445|FG000|Participant Flow|ABCD Sequence|Aggrenox/Aggrenox+Omeprazole/Omeprazole/Aggrenox+Omeprazole
11050101|NCT01303445|FG001|Participant Flow|CDAB Sequence|Omeprazole/Aggrenox+Omeprazole/Aggrenox/Aggrenox+Omeprazole
11050102|NCT01303445|OG000|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
11050103|NCT01303445|OG001|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
11050104|NCT01303445|OG002|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
11050105|NCT01303445|OG003|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
11050106|NCT01303445|EG000|Reported Event|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
11050107|NCT01303445|EG001|Reported Event|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
11050108|NCT01303445|EG002|Reported Event|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
11050109|NCT01303445|EG003|Reported Event|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
11050110|NCT01303510|BG000|Baseline|Group A|Adults from 18 to 60 years old inclusive
11050111|NCT01303510|BG001|Baseline|Group B|Elderly subjects aged over 60 years
11050112|NCT01303510|BG002|Baseline|Total|Total of all reporting groups
11349005|NCT04132336|OG005|Outcome|Caffeine|Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
11050113|NCT01303510|FG000|Participant Flow|Group A|Adults from 18 to 60 years old inclusive
11050114|NCT01303510|FG001|Participant Flow|Group B|Elderly subjects aged over 60 years
11050115|NCT01303510|OG000|Outcome|Group A|Adults from 18 to 60 years old inclusive
11050116|NCT01303510|OG001|Outcome|Group B|Elderly subjects aged over 60 years
11050117|NCT01303510|EG000|Reported Event|Group A|Adults from 18 to 60 years old inclusive
11050118|NCT01303510|EG001|Reported Event|Group B|Elderly subjects aged over 60 years
11050119|NCT01303627|BG000|Baseline|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
11050120|NCT01303627|BG001|Baseline|Control|Control:Remifentanil stopped at the end of the surgery
11050121|NCT01303627|BG002|Baseline|Total|Total of all reporting groups
11050122|NCT01303627|FG000|Participant Flow|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
11349006|NCT04132336|OG006|Outcome|Placebo|Participants received a single dose of two tablets of matching placebo after extraction of third molars
11050123|NCT01303627|FG001|Participant Flow|Control|Control:Remifentanil stopped at the end of the surgery
11050124|NCT01303627|OG000|Outcome|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
11050125|NCT01303627|OG001|Outcome|Control Group|Remifentanil stopped at the and of the surgery
11050126|NCT01303627|EG000|Reported Event|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
11050127|NCT01303627|EG001|Reported Event|Control Group|Remifentanil stopped at the end of the surgery
11050128|NCT01303744|BG000|Baseline|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
11050129|NCT01303744|BG001|Baseline|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
11050130|NCT01303744|BG002|Baseline|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
11050131|NCT01303744|BG003|Baseline|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
11050132|NCT01303744|BG004|Baseline|Total|Total of all reporting groups
11050133|NCT01303744|FG000|Participant Flow|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
11050134|NCT01303744|FG001|Participant Flow|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
11349007|NCT04132336|EG000|Reported Event|Naproxen Sodium/Caffeine-Dose 1|Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
11050135|NCT01303744|FG002|Participant Flow|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
11050136|NCT01303744|FG003|Participant Flow|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
11050137|NCT01303744|OG000|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
11050138|NCT01303744|OG001|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
11050139|NCT01303744|OG002|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
11050140|NCT01303744|OG003|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
11050141|NCT01303744|EG000|Reported Event|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
11050142|NCT01303744|EG001|Reported Event|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
11050143|NCT01303744|EG002|Reported Event|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
11050144|NCT01303744|EG003|Reported Event|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
11050145|NCT01303835|BG000|Baseline|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
11050146|NCT01303835|BG001|Baseline|Placebo|Randomized patients received placebo to be taken every night before bed.
11050147|NCT01303835|BG002|Baseline|Total|Total of all reporting groups
11050148|NCT01303835|FG000|Participant Flow|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
11349008|NCT04132336|EG001|Reported Event|Naproxen Sodium/Caffeine-Dose 2|Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
10847001|NCT00281580|FG006|Participant Flow|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
11050149|NCT01303835|FG001|Participant Flow|Placebo|Randomized patients received placebo to be taken every night before bed.
11050150|NCT01303835|OG000|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
11050151|NCT01303835|OG001|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
11050152|NCT01303835|EG000|Reported Event|Naltrexone|Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.
11050153|NCT01303835|EG001|Reported Event|Placebo|Randomized patients received placebo to be taken every night before bed.
11050154|NCT01303861|BG000|Baseline|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
10847002|NCT00281580|FG007|Participant Flow|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
11050155|NCT01303861|BG001|Baseline|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
11050156|NCT01303861|BG002|Baseline|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
11050157|NCT01303861|BG003|Baseline|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
11050158|NCT01303861|BG004|Baseline|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
11050159|NCT01303861|BG005|Baseline|Total|Total of all reporting groups
11050160|NCT01303861|FG000|Participant Flow|Varenicline|"This group will consist of smokers who, based on smoking behavior, Do NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
11050161|NCT01303861|FG001|Participant Flow|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
11050162|NCT01303861|FG002|Participant Flow|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
11050163|NCT01303861|FG003|Participant Flow|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
11050164|NCT01303861|OG000|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
11050165|NCT01303861|OG001|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
11050166|NCT01303861|OG002|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
11050167|NCT01303861|OG003|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
11226511|NCT02375971|FG001|Participant Flow|Ranibizumab 0.1 mg|1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
10847003|NCT00281580|FG008|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
11050168|NCT01303861|EG000|Reported Event|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
11050169|NCT01303861|EG001|Reported Event|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
11050170|NCT01303861|EG002|Reported Event|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
11050171|NCT01303861|EG003|Reported Event|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
11050172|NCT01303861|EG004|Reported Event|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
11050173|NCT01303939|BG000|Baseline|Glaucoma Patients|Patients who were outliers from the AARV or ADREV Studies.
11050174|NCT01303939|BG001|Baseline|Control Patients|Age, gender and race matched group of healthy individuals with no ocular diseases.
11050175|NCT01303939|BG002|Baseline|Total|Total of all reporting groups
11050176|NCT01303939|FG000|Participant Flow|Glaucoma Patients|Patients were outliers from two previous studies: Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV).
11050177|NCT01303939|FG001|Participant Flow|Control Patients|Age, gender and race matched (to the glaucoma patients) group of healthy individuals with no ocular diseases.
11050178|NCT01303939|OG000|Outcome|Glaucoma Patients|Patients who were outliers from the AARV or ADREV Studies.
11050179|NCT01303939|OG001|Outcome|Control Patients|Age, gender and race matched group of healthy individuals with no ocular diseases.
11050180|NCT01303939|OG000|Outcome|Glaucoma Patients|"Patients who were outliers from two previous studies: Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV) with mini mental status exam score of 25 or higher underwent magnetic resonance imaging (MRI) of the brain to look at structures and volume.~magnetic resonance imaging (MRI) of the brain: High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit."
11050181|NCT01303939|OG001|Outcome|Control Patients|"Age, gender and race matched (to each glaucoma patient) group of healthy individuals with no ocular diseases with mini mental status exam score of 25 or higher underwent magnetic resonance imaging (MRI) of the brain to look at structures and volume.~magnetic resonance imaging (MRI) of the brain: High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit."
11050182|NCT01303939|EG000|Reported Event|Glaucoma Patients|Patients who were outliers from the AARV or ADREV Studies.
11050183|NCT01303939|EG001|Reported Event|Control Patients|Age, gender and race matched group of healthy individuals with no ocular diseases.
11050184|NCT01303965|BG000|Baseline|Phase I Dose Finding|Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
11050185|NCT01303965|BG001|Baseline|Phase II|Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
11050186|NCT01303965|BG002|Baseline|Total|Total of all reporting groups
11050187|NCT01303965|FG000|Participant Flow|Phase I Dose Finding|Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
11050188|NCT01303965|FG001|Participant Flow|Phase II|Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
11050189|NCT01303965|OG000|Outcome|Phase I Dose Finding|Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
11050190|NCT01303965|OG000|Outcome|Phase II|Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
11050191|NCT01303965|EG000|Reported Event|Phase I Dose Finding|Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
11050192|NCT01303965|EG001|Reported Event|Phase II|Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
11050193|NCT01304082|BG000|Baseline|All Study Participants|All study participants
11050194|NCT01304082|FG000|Participant Flow|C, L, A|control, lidocaine, alkalinized lidocaine
11050195|NCT01304082|FG001|Participant Flow|C, A, L|control, alkalinized lidocaine, lidocaine
11050196|NCT01304082|FG002|Participant Flow|L, C, A|lidocaine, control, alkalinized lidocaine
11050197|NCT01304082|FG003|Participant Flow|A, C, L|alkalinized lidocaine, control, lidocaine
11050198|NCT01304082|FG004|Participant Flow|A, L, C|alkalinized lidocaine, lidocaine, control
11050199|NCT01304082|OG000|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
11050200|NCT01304082|OG001|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
11050201|NCT01304082|OG002|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
11050202|NCT01304082|EG000|Reported Event|Normal Saline|1 ml subcutaneous injection 0.9% sodium chloride, given once
11050203|NCT01304082|EG001|Reported Event|Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine, given once
11050204|NCT01304082|EG002|Reported Event|Alkalinized Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
11050205|NCT01304147|BG000|Baseline|Participants Treated|
11050206|NCT01304147|FG000|Participant Flow|Ketamine Then Placebo|Ketamine: A single dose of intranasal ketamine up to 50 mg for 7 days in first intervention. Then Placebo for 7 days in 2nd intervention.
11050207|NCT01304147|FG001|Participant Flow|Placebo, Then Ketamine|placebo: Single dose of saline (0.9% saline solution) intranasal for 7 days in first intervention, then Ketamine 50mg in second intervention.
11349009|NCT04132336|EG002|Reported Event|Naproxen Sodium/Caffeine-Dose 3|Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
11349010|NCT04132336|EG003|Reported Event|Naproxen Sodium/Caffeine-Dose 4|Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
11050208|NCT01304147|OG000|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
11050209|NCT01304147|OG001|Outcome|Placebo|placebo: Single dose of saline intranasal
11050210|NCT01304147|EG000|Reported Event|Ketamine|
11050211|NCT01304147|EG001|Reported Event|Placebo|
11050212|NCT01304238|BG000|Baseline|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
11050213|NCT01304238|BG001|Baseline|Lepirudin|Participants treated with lepirudin after HIT II
11349011|NCT04132336|EG004|Reported Event|Naproxen Sodium|Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
11050214|NCT01304238|BG002|Baseline|Danaparoid|Participants treated with danaparoid after HIT II
11050215|NCT01304238|BG003|Baseline|Fondaparinux|Participants treated with fondaparinux after HIT II
11050216|NCT01304238|BG004|Baseline|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
11050217|NCT01304238|BG005|Baseline|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
11050218|NCT01304238|BG006|Baseline|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
11050219|NCT01304238|BG007|Baseline|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
11050220|NCT01304238|BG008|Baseline|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
11050221|NCT01304238|BG009|Baseline|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
11050222|NCT01304238|BG010|Baseline|Total|Total of all reporting groups
11050223|NCT01304238|FG000|Participant Flow|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
11050224|NCT01304238|FG001|Participant Flow|Lepirudin|Participants treated with lepirudin after HIT II
11050225|NCT01304238|FG002|Participant Flow|Danaparoid|Participants treated with danaparoid after HIT II
11050226|NCT01304238|FG003|Participant Flow|Fondaparinux|Participants treated with fondaparinux after HIT II
11050227|NCT01304238|FG004|Participant Flow|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
11050228|NCT01304238|FG005|Participant Flow|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
11050229|NCT01304238|FG006|Participant Flow|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
11050230|NCT01304238|FG007|Participant Flow|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
11050231|NCT01304238|FG008|Participant Flow|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
11050232|NCT01304238|FG009|Participant Flow|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
11050233|NCT01304238|OG000|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
11050234|NCT01304238|OG001|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
11050235|NCT01304238|OG002|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
11050236|NCT01304238|OG003|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
11050237|NCT01304238|OG004|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
11050238|NCT01304238|OG005|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
11050239|NCT01304238|OG006|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
11050240|NCT01304238|OG007|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
11050241|NCT01304238|OG008|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
11050242|NCT01304238|OG009|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
11050243|NCT01304238|EG000|Reported Event|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
11050244|NCT01304238|EG001|Reported Event|Lepirudin|Participants treated with lepirudin after HIT II
11050245|NCT01304238|EG002|Reported Event|Danaparoid|Participants treated with danaparoid after HIT II
11050246|NCT01304238|EG003|Reported Event|Fondaparinux|Participants treated with fondaparinux after HIT II
11050247|NCT01304238|EG004|Reported Event|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
11050248|NCT01304238|EG005|Reported Event|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
11050249|NCT01304238|EG006|Reported Event|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
11050250|NCT01304238|EG007|Reported Event|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
11050251|NCT01304238|EG008|Reported Event|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
11349012|NCT04132336|EG005|Reported Event|Caffeine|Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
11050252|NCT01304238|EG009|Reported Event|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
11050253|NCT01304277|BG000|Baseline|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
11050254|NCT01304277|FG000|Participant Flow|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
11050255|NCT01304277|OG000|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
11050256|NCT01304277|OG000|Outcome|Replagal RB|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082.
11050257|NCT01304277|OG001|Outcome|Replagal AF|Patients received 7 EOW infusions of treatment with Replagal AF from week 2 to week 14 in REP-082.
11050258|NCT01304277|OG002|Outcome|Overall|Overall number of patients who experienced adverse events during the course of REP-082 study.
11050259|NCT01304277|EG000|Reported Event|Replagal® (0.2 mg/kg, IV, EOW)|Overall patients that participated in REP-082
11050260|NCT01304329|BG000|Baseline|Study Overall|This was a randomised, 3-period, crossover trial. The trial was open label. The three treatments were separated by a washout period of at least 7 days.
11050261|NCT01304329|FG000|Participant Flow|Empa Alone / Simvastatin Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg together with 40mg simvastatin"
11050262|NCT01304329|FG001|Participant Flow|Empa Alone / Empa Plus Sim / Simvastatin Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of simvastatin 40mg"
11050263|NCT01304329|FG002|Participant Flow|Simvastatin Alone / Empa Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg~A single dose of empagliflozin 25mg together with 40mg simvastatin"
11050264|NCT01304329|FG003|Participant Flow|Simvastatin Alone / Empa Plus Sim / Empa Alone|"Patients were administered three treatments in the following order:~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of empagliflozin 25mg"
11050265|NCT01304329|FG004|Participant Flow|Empa Plus Sim / Empa Alone / Simvastatin Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of empagliflozin 25mg~A single dose of simvastatin 40mg"
11050266|NCT01304329|FG005|Participant Flow|Empa Plus Sim / Simvastatin Alone / Empa Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg"
11050267|NCT01304329|OG000|Outcome|Empa Alone|25mg empagliflozin (empa) alone
11050268|NCT01304329|OG001|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
11050269|NCT01304329|OG000|Outcome|Simvastatin Alone|40 mg simvastatin alone
11050270|NCT01304329|EG000|Reported Event|Empa Alone|25mg empagliflozin (empa) alone
11050271|NCT01304329|EG001|Reported Event|Simvastatin Alone|40 mg simvastatin alone
11050272|NCT01304329|EG002|Reported Event|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
11050273|NCT01304407|BG000|Baseline|RTS Patients|Rothmond-Thompson patients receiving 5 mg 42Ca, 46Ca stable isotopes to evaluate bone calcium deposition
11050274|NCT01304407|FG000|Participant Flow|RTS Patients|Rothmond-Thompson patients receiving 5 mg 42Ca, 46Ca stable isotopes to evaluate bone calcium deposition
11050275|NCT01304407|OG000|Outcome|RTS Patients|Rothmond-Thompson patients receiving 5 mg 42Ca, 46Ca stable isotopes to evaluate bone calcium deposition
11050276|NCT01304407|EG000|Reported Event|RTS Patients|Rothmond-Thompson patients receiving 5 mg 42Ca, 46Ca stable isotopes to evaluate bone calcium deposition
11050277|NCT01304498|BG000|Baseline|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11050278|NCT01304498|BG001|Baseline|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11050279|NCT01304498|BG002|Baseline|Total|Total of all reporting groups
11050280|NCT01304498|FG000|Participant Flow|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11050281|NCT01304498|FG001|Participant Flow|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11050282|NCT01304498|OG000|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11050283|NCT01304498|OG001|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11050284|NCT01304498|EG000|Reported Event|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11050285|NCT01304498|EG001|Reported Event|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11050286|NCT01304589|BG000|Baseline|Milnacipram|Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
11050287|NCT01304589|FG000|Participant Flow|Milnacipran|Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
11050288|NCT01304589|OG000|Outcome|Milnacipram|Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
11050289|NCT01304589|OG000|Outcome|Milnacipran|Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
11050290|NCT01304589|EG000|Reported Event|Milnacipram|Crossover study
11050291|NCT01304641|BG000|Baseline|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
11050292|NCT01304641|BG001|Baseline|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
11050293|NCT01304641|BG002|Baseline|Total|Total of all reporting groups
11050294|NCT01304641|FG000|Participant Flow|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
11050295|NCT01304641|FG001|Participant Flow|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
11050296|NCT01304641|OG000|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
11050297|NCT01304641|OG001|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
11050298|NCT01304641|EG000|Reported Event|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
11050299|NCT01304641|EG001|Reported Event|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
11050300|NCT01304693|BG000|Baseline|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
11050301|NCT01304693|BG001|Baseline|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
11050302|NCT01304693|BG002|Baseline|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
11050303|NCT01304693|BG003|Baseline|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
11050304|NCT01304693|BG004|Baseline|Lucentis|Single intravitreal injection with 6-month follow-up
11050305|NCT01304693|BG005|Baseline|Total|Total of all reporting groups
11050306|NCT01304693|FG000|Participant Flow|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
11050307|NCT01304693|FG001|Participant Flow|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
11050308|NCT01304693|FG002|Participant Flow|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
11050309|NCT01304693|FG003|Participant Flow|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
11050310|NCT01304693|FG004|Participant Flow|Lucentis|Single intravitreal injection with 6-month follow-up
11050311|NCT01304693|OG000|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
11050312|NCT01304693|OG001|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
11050313|NCT01304693|OG002|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
11050314|NCT01304693|OG003|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
11050315|NCT01304693|OG004|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
11050316|NCT01304693|EG000|Reported Event|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
11050317|NCT01304693|EG001|Reported Event|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
11050318|NCT01304693|EG002|Reported Event|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
11050319|NCT01304693|EG003|Reported Event|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
11050320|NCT01304693|EG004|Reported Event|Lucentis|Single intravitreal injection with 6-month follow-up
11050321|NCT01304706|BG000|Baseline|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
11050322|NCT01304706|FG000|Participant Flow|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
11050323|NCT01304706|OG000|Outcome|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
11050324|NCT01304706|EG000|Reported Event|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
11050325|NCT01304940|BG000|Baseline|PTSD Group|Individuals in this group meet criteria for PTSD as defined by DSM-IV
11050326|NCT01304940|BG001|Baseline|Trauma Control Group|individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV
11050327|NCT01304940|BG002|Baseline|Total|Total of all reporting groups
11050328|NCT01304940|FG000|Participant Flow|PTSD Group|Individuals in this group meet criteria for PTSD as defined by DSM-IV
11050329|NCT01304940|FG001|Participant Flow|Trauma Control Group|individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV
11050330|NCT01304940|OG000|Outcome|PTSD Group|Individuals in this group meet criteria for PTSD as defined by DSM-IV
11050331|NCT01304940|OG001|Outcome|Trauma Control Group|individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV
11050332|NCT01304940|EG000|Reported Event|PTSD Group|Individuals in this group meet criteria for PTSD as defined by DSM-IV
11050333|NCT01304940|EG001|Reported Event|Trauma Control Group|individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV
11050334|NCT01304966|BG000|Baseline|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
11050335|NCT01304966|FG000|Participant Flow|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
11050336|NCT01304966|OG000|Outcome|Children With Recurrent Respiratory Papillomatosis|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
11050337|NCT01304966|OG000|Outcome|HPV 6|Children with recurrent respiratory papillomatosis from HPV 6
11050338|NCT01304966|OG001|Outcome|HPV 11|Children with recurrent respiratory papillomatosis from HPV 11
11050339|NCT01304966|EG000|Reported Event|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
11050340|NCT01305044|BG000|Baseline|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
11050341|NCT01305044|BG001|Baseline|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
11050342|NCT01305044|BG002|Baseline|Total|Total of all reporting groups
11050343|NCT01305044|FG000|Participant Flow|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
11050344|NCT01305044|FG001|Participant Flow|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
11050345|NCT01305044|OG000|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
11050346|NCT01305044|OG001|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
11050347|NCT01305044|EG000|Reported Event|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
11050348|NCT01305044|EG001|Reported Event|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
11050349|NCT01305200|BG000|Baseline|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
11050350|NCT01305200|BG001|Baseline|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
11050351|NCT01305200|BG002|Baseline|Arm III (Enrolled Not Randomized)|Site not able to randomize.
11050352|NCT01305200|BG003|Baseline|Total|Total of all reporting groups
11050353|NCT01305200|FG000|Participant Flow|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
11226512|NCT02375971|FG002|Participant Flow|Laser Therapy|Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
11050354|NCT01305200|FG001|Participant Flow|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
11050355|NCT01305200|FG002|Participant Flow|Arm III (Enrolled But Not Randomized)|Site not randomized
11050356|NCT01305200|OG000|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
11050357|NCT01305200|OG001|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
11050358|NCT01305200|EG000|Reported Event|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
11050359|NCT01305200|EG001|Reported Event|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
11050360|NCT01305213|BG000|Baseline|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
11050361|NCT01305213|BG001|Baseline|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
11050362|NCT01305213|BG002|Baseline|Total|Total of all reporting groups
11050363|NCT01305213|FG000|Participant Flow|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
11050364|NCT01305213|FG001|Participant Flow|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
11050365|NCT01305213|OG000|Outcome|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
11050366|NCT01305213|OG001|Outcome|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
11050367|NCT01305213|OG000|Outcome|Non Measurable Disease Patients|Patients with non measurable disease
11050368|NCT01305213|OG001|Outcome|Measurable Disease Patients|Patients with measurable disease
11050369|NCT01305213|OG000|Outcome|Non Measurble Disease|Patients with non measurable disease
11050370|NCT01305213|EG000|Reported Event|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
11050371|NCT01305213|EG001|Reported Event|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
11050372|NCT01305239|BG000|Baseline|Exemestane|25 mg oral tablet once a day
11050373|NCT01305239|FG000|Participant Flow|Exemestane|25 mg oral tablet once a day
11050374|NCT01305239|OG000|Outcome|Exemestane|25 mg oral tablet once a day
11050375|NCT01305239|EG000|Reported Event|Exemestane|25 mg oral tablet once a day
11050376|NCT01305252|BG000|Baseline|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050377|NCT01305252|BG001|Baseline|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050378|NCT01305252|BG002|Baseline|Total|Total of all reporting groups
11050379|NCT01305252|FG000|Participant Flow|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050380|NCT01305252|FG001|Participant Flow|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050381|NCT01305252|OG000|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050382|NCT01305252|OG001|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050383|NCT01305252|OG000|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050384|NCT01305252|OG001|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050385|NCT01305252|OG000|Outcome|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050386|NCT01305252|OG001|Outcome|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050387|NCT01305252|EG000|Reported Event|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050388|NCT01305252|EG001|Reported Event|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
11050389|NCT01305265|BG000|Baseline|Control Group|Endotracheal tube cuff inflated using the inflate & palpate technique
11050390|NCT01305265|BG001|Baseline|Intervention Group|Endotracheal tube cuff inflated using the inflate & palpate technique. The cuff pressure then was adjusted to 22-26cmH2O within 15min after endotracheal intubation by trained study staff.
11050391|NCT01305265|BG002|Baseline|Total|Total of all reporting groups
11050392|NCT01305265|FG000|Participant Flow|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
11050393|NCT01305265|FG001|Participant Flow|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
11050394|NCT01305265|OG000|Outcome|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
11050395|NCT01305265|OG001|Outcome|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
11050396|NCT01305265|EG000|Reported Event|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
11050397|NCT01305265|EG001|Reported Event|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
11050398|NCT01305356|BG000|Baseline|Augment® Injectable Bone Graft|"Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)~Augment® Injectable Bone Graft: Implantation of up to 9cc of Augment® Injectable Bone Graft"
11050399|NCT01305356|BG001|Baseline|Autologous Bone Graft|"Standard Rigid Fixation + Autologous bone graft~Autologous bone graft: Implantation of up to 9cc of autologous bone graft"
11050400|NCT01305356|BG002|Baseline|Total|Total of all reporting groups
11050401|NCT01305356|FG000|Participant Flow|Augment® Injectable Bone Graft|Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
11050402|NCT01305356|FG001|Participant Flow|Autologous Bone Graft|Standard Rigid Fixation + Autologous bone graft
11050403|NCT01305356|OG000|Outcome|Augment® Injectable Bone Graft|Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
11050404|NCT01305356|OG001|Outcome|Autologous Bone Graft|Standard Rigid Fixation + Autologous bone graft
11050405|NCT01305356|EG000|Reported Event|Augment® Injectable Bone Graft|Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
11050406|NCT01305356|EG001|Reported Event|Autologous Bone Graft|Standard Rigid Fixation + Autologous bone graft
11050407|NCT01305408|BG000|Baseline|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
11050408|NCT01305408|BG001|Baseline|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
11050409|NCT01305408|BG002|Baseline|Total|Total of all reporting groups
11050410|NCT01305408|FG000|Participant Flow|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
11050411|NCT01305408|FG001|Participant Flow|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
11050412|NCT01305408|OG000|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
11050413|NCT01305408|OG001|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
11349013|NCT04132336|EG006|Reported Event|Placebo|Participants received a single dose of two tablets of matching placebo after extraction of third molars
11050414|NCT01305408|EG000|Reported Event|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
11050415|NCT01305408|EG001|Reported Event|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
11050416|NCT01305473|BG000|Baseline|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
11050417|NCT01305473|FG000|Participant Flow|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
11050418|NCT01305473|OG000|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
11050419|NCT01305473|EG000|Reported Event|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
11050420|NCT01305564|BG000|Baseline|Baseline Characteristics|All treated with Denali filter.
11050421|NCT01305564|FG000|Participant Flow|Denali Inferior Vena Cava Filter|"All subjects enrolled will receive the Denali vena cava filter.~Denali inferior vena cava filter: The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube."
11050422|NCT01305564|OG000|Outcome|Technical Success of Placement|Primary implant endpoint
11050423|NCT01305564|OG000|Outcome|Clinical Success of Placement|
11050424|NCT01305564|OG000|Outcome|Technical Success of Retrieval|
11050425|NCT01305564|OG000|Outcome|Clinical Success of Retrieval|
11050426|NCT01305564|OG000|Outcome|Recurrent PE|
11050427|NCT01305564|OG000|Outcome|New or Worsening DVT|
11050428|NCT01305564|OG000|Outcome|Filter Fracture|
11050429|NCT01305564|OG000|Outcome|Filter Migration >2 cm|
11050430|NCT01305564|OG000|Outcome|Filter Tilt|At Implant
11050431|NCT01305564|OG000|Outcome|Filter Tilt|At Retrieval
11050432|NCT01305564|OG000|Outcome|Filter Penetration at Placement|
11050433|NCT01305564|OG000|Outcome|Filter Penetration at Retrieval|
11050434|NCT01305564|EG000|Reported Event|Serious Adverse Events|"Serious Adverse Events are reported for all 200 subjects and all serious events are reported.~Non-serious adverse events are reported when the reported threshold for an event is at 5% or higher. This represents 175 subjects and not 200 for non-serious events."
11050435|NCT01305577|BG000|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050436|NCT01305577|BG001|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050437|NCT01305577|BG002|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050438|NCT01305577|BG003|Baseline|Total|Total of all reporting groups
11050439|NCT01305577|FG000|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050440|NCT01305577|FG001|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050441|NCT01305577|FG002|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050442|NCT01305577|OG000|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050443|NCT01305577|OG001|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050444|NCT01305577|OG002|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050445|NCT01305577|EG000|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050446|NCT01305577|EG001|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050447|NCT01305577|EG002|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11050448|NCT01305655|BG000|Baseline|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.~Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values."
11050449|NCT01305655|FG000|Participant Flow|Glucarpidase Arm|In children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
11050450|NCT01305655|OG000|Outcome|Glucarpidase Arm|47 children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
11050451|NCT01305655|EG000|Reported Event|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.~Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.~No serious effect reported."
11050452|NCT01305772|BG000|Baseline|Radiation Therapy|Patients who underwent radiation therapy only, in conjunction with panitumumab therapy
11050453|NCT01305772|BG001|Baseline|Surgery|Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration
11050454|NCT01305772|BG002|Baseline|Total|Total of all reporting groups
11050455|NCT01305772|FG000|Participant Flow|Radiation Therapy|"Patients who underwent radiation therapy only, in conjunction with panitumumab therapy.~Radiation Therapy : Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.~Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT."
11050456|NCT01305772|FG001|Participant Flow|Surgery|"Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration~Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT.~Surgery : Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site)."
11050457|NCT01305772|OG000|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
11050458|NCT01305772|EG000|Reported Event|Radiation Therapy|Radiation therapy with panitumumab therapy.
11050459|NCT01305772|EG001|Reported Event|Surgery|Surgery after research PET/CT scans and subsequent radiation therapy with panitumumab therapy.
11050460|NCT01305811|BG000|Baseline|Bi-weekly Acupuncture Treatment|Bi-weekly acupuncture treatment for 6 months
11050461|NCT01305811|BG001|Baseline|Wait List|Wait list for 2 months then weekly acupuncture for four months
11050462|NCT01305811|BG002|Baseline|Total|Total of all reporting groups
11050463|NCT01305811|FG000|Participant Flow|Bi-weekly Acupuncture Treatment|Veterans with diagnosed symptoms of Gulf War Illness were randomized to six months of biweekly acupuncture treatments.
11050464|NCT01305811|FG001|Participant Flow|Wait List|Veterans with diagnosed symptoms of Gulf War Illness were randomized to 2 months of waitlist followed by weekly acupuncture treatments for 4 months.
11050465|NCT01305811|OG000|Outcome|Bi-Weekly Acupuncture|group mean SF-36 P score at 6 months
11050466|NCT01305811|OG001|Outcome|Wait List Then Weekly Acupuncture|group mean SF-36 P score at 6 months
11050467|NCT01305811|OG000|Outcome|Bi-weekly Acupuncture Treatment|"Bi-weekly acupuncture treatment~Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
11050468|NCT01305811|OG001|Outcome|Wait List|"Wait list for 2 months.~Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
11050469|NCT01305811|EG000|Reported Event|Bi-Weekly Acupuncture|"Bi-Weekly Acupuncture for 6 months~1 serious unexpected adverse event in the biweekly group: Subject's practitioner was told by subject of a suicide attempt. Case was reviewed and the medical monitor and identified as needing follow up. Subject was hospitalized for observation, released to his daughter's custody. Both the VA and the Crisis Center were in touch with him on Feb 27th and are making arrangements to take him, (patient reported), either in patient or into a program. He had a follow-up appointment Feb 28th at the VA and he was hospitalized at this time and is currently hospitalized.~The practitioner will also follow up with subject's PCP."
11050470|NCT01305811|EG001|Reported Event|Wait List|"Wait list for 2 months followed by 4 months of weekly acupuncture~No Adverse events were reported in the Wait list group"
11050471|NCT01305941|BG000|Baseline|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
11050472|NCT01305941|FG000|Participant Flow|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
11050473|NCT01305941|OG000|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
11050474|NCT01305941|EG000|Reported Event|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
11050475|NCT01306032|BG000|Baseline|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
11050476|NCT01306032|BG001|Baseline|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050477|NCT01306032|BG002|Baseline|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
11050478|NCT01306032|BG003|Baseline|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050479|NCT01306032|BG004|Baseline|Non-Hodgkin's: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
11050480|NCT01306032|BG005|Baseline|Non-Hodgkin's: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050481|NCT01306032|BG006|Baseline|Total|Total of all reporting groups
11050482|NCT01306032|FG000|Participant Flow|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050483|NCT01306032|FG001|Participant Flow|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
11050484|NCT01306032|FG002|Participant Flow|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050485|NCT01306032|FG003|Participant Flow|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
11050486|NCT01306032|FG004|Participant Flow|Non-Hodgkin's: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050487|NCT01306032|FG005|Participant Flow|Non-Hodgkin's: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
11050488|NCT01306032|OG000|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050489|NCT01306032|OG001|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050490|NCT01306032|OG002|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050491|NCT01306032|OG003|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050492|NCT01306032|OG004|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050493|NCT01306032|OG005|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050494|NCT01306032|OG002|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050495|NCT01306032|OG003|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050496|NCT01306032|OG000|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050497|NCT01306032|OG001|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050498|NCT01306032|OG002|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050499|NCT01306032|OG003|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
11050500|NCT01306032|OG004|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050501|NCT01306032|OG005|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050502|NCT01306032|OG006|Outcome|Non-Hodgkin's: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050503|NCT01306032|OG007|Outcome|Non-Hodgkin's: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050504|NCT01306032|EG000|Reported Event|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050505|NCT01306032|EG001|Reported Event|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050506|NCT01306032|EG002|Reported Event|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050507|NCT01306032|EG003|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050508|NCT01306032|EG004|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050509|NCT01306032|EG005|Reported Event|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050510|NCT01306032|EG006|Reported Event|Non-Hodgkin's: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
11050511|NCT01306032|EG007|Reported Event|Non-Hodgkin's: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
11050512|NCT01306058|BG000|Baseline|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
11050513|NCT01306058|FG000|Participant Flow|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
11050514|NCT01306058|OG000|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
11050515|NCT01306058|EG000|Reported Event|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
11050516|NCT01306162|BG000|Baseline|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
11050517|NCT01306162|BG001|Baseline|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
11050518|NCT01306162|BG002|Baseline|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
11050519|NCT01306162|BG003|Baseline|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
11050520|NCT01306162|BG004|Baseline|Total|Total of all reporting groups
11050521|NCT01306162|FG000|Participant Flow|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
11226513|NCT02375971|OG000|Outcome|Ranibizumab 0.2 mg|1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
11050522|NCT01306162|FG001|Participant Flow|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
11050523|NCT01306162|FG002|Participant Flow|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
11050524|NCT01306162|FG003|Participant Flow|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
11050525|NCT01306162|OG000|Outcome|150mg DE (TrtA)|Dabigatran 150mg
11050526|NCT01306162|OG001|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
11050527|NCT01306162|OG002|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
11050528|NCT01306162|OG003|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
11050529|NCT01306162|OG004|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
11050530|NCT01306162|EG000|Reported Event|150mg DE (TrtA)|Dabigatran 150mg
11050531|NCT01306162|EG001|Reported Event|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
11050532|NCT01306162|EG002|Reported Event|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
11050533|NCT01306162|EG003|Reported Event|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
11050534|NCT01306162|EG004|Reported Event|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
11050535|NCT01306162|EG005|Reported Event|400mg DR + 400mg DR Bid 2h Later (TrtE2)|Dronedarone 400mg + Dronedarone 400mg bid given 2h later
11050536|NCT01306175|BG000|Baseline|Study Total|"This was a randomised, two-period, cross-over trial, the two treatments administered were~A single dose of digoxin 0.5 mg on day 1~Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5~Between treatment periods there was a washout period of at least 14 days."
11050537|NCT01306175|FG000|Participant Flow|Study Total|"This was a randomised, two-period cross-over trial, the two treatments administered were~A single dose of 0.5mg digoxin on day 1~empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5~Between treatment periods there was a washout period of at least 14 days."
11050538|NCT01306175|OG000|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
11050539|NCT01306175|OG001|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
11050540|NCT01306175|EG000|Reported Event|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
11050541|NCT01306175|EG001|Reported Event|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
11050542|NCT01306201|BG000|Baseline|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
11050543|NCT01306201|FG000|Participant Flow|Respiration Rate in GCF Patients|In-patients from the hospital general care floor, who choose to participate in the study. Participants were monitored for 30 minute periods to collect respiratory rate information from non-invasive sensors.
11050544|NCT01306201|OG000|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration rate determined by novel plethysmographic analysis
11050545|NCT01306201|OG001|Outcome|Respiration Rate From Endtidal Carbon Dioxide Waveform|Respiration rate determined by manual overscoring of capnography waveforms
11050546|NCT01306201|OG002|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate derived from Transthoracic Impedance
11050547|NCT01306201|OG000|Outcome|Overall Study Population|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
11050548|NCT01306201|OG000|Outcome|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
11050549|NCT01306201|EG000|Reported Event|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
11050550|NCT01306214|BG000|Baseline|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
11050551|NCT01306214|BG001|Baseline|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
11050552|NCT01306214|BG002|Baseline|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
11050553|NCT01306214|BG003|Baseline|Total|Total of all reporting groups
11050554|NCT01306214|FG000|Participant Flow|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
11050555|NCT01306214|FG001|Participant Flow|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
11050556|NCT01306214|FG002|Participant Flow|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
11050557|NCT01306214|OG000|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
11050558|NCT01306214|OG001|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
11050559|NCT01306214|OG002|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
11050560|NCT01306214|EG000|Reported Event|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
11050561|NCT01306214|EG001|Reported Event|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
11050562|NCT01306214|EG002|Reported Event|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
11050563|NCT01306253|BG000|Baseline|Adults|Adults from 18 to 60 years old inclusive
11050564|NCT01306253|BG001|Baseline|Elderly|Elderly subjects aged over 60 years
11050565|NCT01306253|BG002|Baseline|Total|Total of all reporting groups
11050566|NCT01306253|FG000|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
11050567|NCT01306253|FG001|Participant Flow|Elderly|Elderly subjects aged over 60 years
11050568|NCT01306253|OG000|Outcome|Adults|Adults from 18 to 60 years old inclusive
11050569|NCT01306253|OG001|Outcome|Elderly|Elderly subjects aged over 60 years
11050570|NCT01306253|EG000|Reported Event|Adults|Adults from 18 to 60 years old inclusive
11050571|NCT01306253|EG001|Reported Event|Elderly|Elderly subjects aged over 60 years
11050572|NCT01306292|BG000|Baseline|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
11050573|NCT01306292|BG001|Baseline|Normal Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
11050574|NCT01306292|BG002|Baseline|Total|Total of all reporting groups
11050575|NCT01306292|FG000|Participant Flow|Hypertension Group (SonoVue First, Then Placebo)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
11050576|NCT01306292|FG001|Participant Flow|Hypertension Group (Placebo First, Then SonoVue)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
11050577|NCT01306292|FG002|Participant Flow|Normal Group (SonoVue First, Then Placebo)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
11050578|NCT01306292|FG003|Participant Flow|Normal Group (Placebo First, Then SonoVue)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
11050579|NCT01306292|OG000|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
11050580|NCT01306292|OG001|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
11050581|NCT01306292|OG002|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
11050582|NCT01306292|OG003|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
11050583|NCT01306292|EG000|Reported Event|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
11050584|NCT01306292|EG001|Reported Event|Normal Pulmonary Pressure Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
11050585|NCT01306305|BG000|Baseline|Adults|Adults from 18 to 60 years old inclusive
11050586|NCT01306305|BG001|Baseline|Elderly|Elderly subjects aged over 60 years
11050587|NCT01306305|BG002|Baseline|Total|Total of all reporting groups
11050588|NCT01306305|FG000|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
11050589|NCT01306305|FG001|Participant Flow|Elderly|Elderly subjects aged over 60 years
11050590|NCT01306305|OG000|Outcome|Adults|Adults from 18 to 60 years old inclusive
11050591|NCT01306305|OG001|Outcome|Elderly|Elderly subjects aged over 60 years
11050592|NCT01306305|EG000|Reported Event|Adults|Adults from 18 to 60 years old inclusive
11050593|NCT01306305|EG001|Reported Event|Elderly|Elderly subjects aged over 60 years
11050594|NCT01306331|BG000|Baseline|Conceptrol|"100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel~Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel."
11050595|NCT01306331|BG001|Baseline|Amphora|"Citric acid USP, potassium bitartrate USP, and L-lactic acid USP~Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel."
11050596|NCT01306331|BG002|Baseline|Total|Total of all reporting groups
11050597|NCT01306331|FG000|Participant Flow|Conceptrol|"100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel~Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel."
11050598|NCT01306331|FG001|Participant Flow|Amphora|"Citric acid USP, potassium bitartrate USP, and L-lactic acid USP~Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel."
11050599|NCT01306331|OG000|Outcome|Conceptrol|"100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel~Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel."
11050600|NCT01306331|OG001|Outcome|Amphora|"Citric acid USP, potassium bitartrate USP, and L-lactic acid USP~Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel."
11050601|NCT01306331|EG000|Reported Event|Conceptrol|"100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel~Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel."
11050602|NCT01306331|EG001|Reported Event|Amphora|"Citric acid USP, potassium bitartrate USP, and L-lactic acid USP~Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel."
11050603|NCT01306617|BG000|Baseline|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
11050604|NCT01306617|BG001|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
11050605|NCT01306617|BG002|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
11050606|NCT01306617|BG003|Baseline|Total|Total of all reporting groups
11050607|NCT01306617|FG000|Participant Flow|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
11050608|NCT01306617|FG001|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
11050609|NCT01306617|FG002|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
11050610|NCT01306617|OG000|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
11050611|NCT01306617|OG001|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
11050612|NCT01306617|OG002|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
11050613|NCT01306617|EG000|Reported Event|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
11050614|NCT01306617|EG001|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
11050615|NCT01306617|EG002|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
11050616|NCT01306643|BG000|Baseline|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
11050617|NCT01306643|FG000|Participant Flow|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
11050618|NCT01306643|OG000|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
11050619|NCT01306643|EG000|Reported Event|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
11050620|NCT01306656|BG000|Baseline|10,000 IU Vitamin D3 + Multivitamin|"10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D~10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week~Months 2-6: 10,000 IU vitamin D3 once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050621|NCT01306656|BG001|Baseline|Placebo + Multivitamin|"Placebo plus a multivitamin with 400 IU vitamin D~Placebo: Month 1: Placebo once a week~Months 2-6: Placebo once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050622|NCT01306656|BG002|Baseline|Total|Total of all reporting groups
11050623|NCT01306656|FG000|Participant Flow|10,000 IU Vitamin D3 + Multivitamin|"10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D~10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week~Months 2-6: 10,000 IU vitamin D3 once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050624|NCT01306656|FG001|Participant Flow|Placebo + Multivitamin|"Placebo plus a multivitamin with 400 IU vitamin D~Placebo: Month 1: Placebo once a week~Months 2-6: Placebo once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050625|NCT01306656|OG000|Outcome|10,000 IU Vitamin D3 + Multivitamin|"10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D~10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week~Months 2-6: 10,000 IU vitamin D3 once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11226514|NCT02375971|OG001|Outcome|Ranibizumab 0.1 mg|1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
11050626|NCT01306656|OG001|Outcome|Placebo + Multivitamin|"Placebo plus a multivitamin with 400 IU vitamin D~Placebo: Month 1: Placebo once a week~Months 2-6: Placebo once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050627|NCT01306656|OG000|Outcome|Group 1|"10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D~10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week~Months 2-6: 10,000 IU vitamin D3 once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050628|NCT01306656|OG001|Outcome|Group 2|"Placebo plus a multivitamin with 400 IU vitamin D~Placebo: Month 1: Placebo once a week~Months 2-6: Placebo once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050629|NCT01306656|EG000|Reported Event|Group 1|"10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D~10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week~Months 2-6: 10,000 IU vitamin D3 once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050630|NCT01306656|EG001|Reported Event|Group 2|"Placebo plus a multivitamin with 400 IU vitamin D~Placebo: Month 1: Placebo once a week~Months 2-6: Placebo once a week~Vitamin D: Daily multivitamin with 400 IU vitamin D."
11050631|NCT01306877|BG000|Baseline|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
11050632|NCT01306877|BG001|Baseline|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
11050633|NCT01306877|BG002|Baseline|Total|Total of all reporting groups
11050634|NCT01306877|FG000|Participant Flow|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set : Surgical device
11050635|NCT01306877|FG001|Participant Flow|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set : Surgical device
11050636|NCT01306877|OG000|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
11050637|NCT01306877|OG001|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
11050638|NCT01306877|EG000|Reported Event|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
11050639|NCT01306877|EG001|Reported Event|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
11050640|NCT01306890|BG000|Baseline|Sipuleucel-T|sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
11050641|NCT01306890|FG000|Participant Flow|Sipuleucel-T|sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
11050642|NCT01306890|OG000|Outcome|Sipuleucel-T|sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
11050643|NCT01306890|EG000|Reported Event|Sipuleucel-T|sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
11050644|NCT01306942|BG000|Baseline|Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050645|NCT01306942|BG001|Baseline|Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050646|NCT01306942|BG002|Baseline|PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2|Phase II with recommended Phase II Dose (RP2D) Dasatinib 100mg: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Two patients from phase I with measurable disease and RP2D were included in the phase II analyses.
11050647|NCT01306942|BG003|Baseline|Total|Total of all reporting groups
11050648|NCT01306942|FG000|Participant Flow|Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050649|NCT01306942|FG001|Participant Flow|Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050650|NCT01306942|FG002|Participant Flow|Dasatinib 70mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 3: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 70mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11226515|NCT02375971|OG002|Outcome|Laser Therapy|Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
11050651|NCT01306942|FG003|Participant Flow|PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2|Phase II with recommended Phase II Dose (RP2D) Dasatinib 100mg: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Two patients from phase I with measurable disease and RP2D were included in the phase II analyses.
11050652|NCT01306942|OG000|Outcome|Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2|Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050653|NCT01306942|OG001|Outcome|Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2|Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050654|NCT01306942|OG000|Outcome|Phase I: Dasatinib + Trastuzumab + Paclitaxel|Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib was administered orally in two dose levels 100 and 140 mg once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050655|NCT01306942|OG000|Outcome|Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2|Phase II with recommended Phase II Dose (RP2D) Dasatinib 100mg: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Two patients from phase I with measurable disease and RP2D were included in the phase II analyses.
11050656|NCT01306942|OG000|Outcome|Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050657|NCT01306942|OG001|Outcome|Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050658|NCT01306942|OG002|Outcome|PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2|Phase II with recommended Phase II Dose (RP2D) Dasatinib 100mg: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Two patients from phase I with measurable disease and RP2D were included in the phase II analyses.
11050659|NCT01306942|EG000|Reported Event|Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050660|NCT01306942|EG001|Reported Event|Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2|Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.
11050661|NCT01306942|EG002|Reported Event|PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2|Phase II with recommended Phase II Dose (RP2D) Dasatinib 100mg: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Two patients from phase I with measurable disease and RP2D were included in the phase II analyses.
11050662|NCT01306968|BG000|Baseline|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
11050663|NCT01306968|BG001|Baseline|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
11226516|NCT02375971|EG000|Reported Event|Ranibizumab 0.2 mg|1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
11226517|NCT02375971|EG001|Reported Event|Ranibizumab 0.1 mg|1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
11226518|NCT02375971|EG002|Reported Event|Laser|Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
11050664|NCT01306968|BG002|Baseline|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
11050665|NCT01306968|BG003|Baseline|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
11050666|NCT01306968|BG004|Baseline|Total|Total of all reporting groups
11050667|NCT01306968|FG000|Participant Flow|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
11050668|NCT01306968|FG001|Participant Flow|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
11050669|NCT01306968|FG002|Participant Flow|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
11050670|NCT01306968|FG003|Participant Flow|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
11050671|NCT01306968|OG000|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
11050672|NCT01306968|OG001|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
11050673|NCT01306968|OG002|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
11050674|NCT01306968|OG003|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
11050675|NCT01306968|OG001|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) Follow-up visit 2 = Day 56 (up to day 100)
11050676|NCT01306968|OG002|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
11050677|NCT01306968|EG000|Reported Event|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
11050678|NCT01306968|EG001|Reported Event|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
11050679|NCT01306968|EG002|Reported Event|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
11050680|NCT01306968|EG003|Reported Event|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
11050681|NCT01307007|BG000|Baseline|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
11050682|NCT01307007|BG001|Baseline|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
11050683|NCT01307007|BG002|Baseline|Total|Total of all reporting groups
11050684|NCT01307007|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
11050685|NCT01307007|FG001|Participant Flow|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
11050686|NCT01307007|OG000|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM): 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
11050687|NCT01307007|OG001|Outcome|Iron Dextran Injection|Iron Dextran Injection: Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
11050688|NCT01307007|EG000|Reported Event|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
11050689|NCT01307007|EG001|Reported Event|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
11050690|NCT01307020|BG000|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
11050691|NCT01307020|BG001|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
11050692|NCT01307020|BG002|Baseline|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
11050693|NCT01307020|BG003|Baseline|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
11050694|NCT01307020|BG004|Baseline|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
11050695|NCT01307020|BG005|Baseline|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
11050696|NCT01307020|BG006|Baseline|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
11050697|NCT01307020|BG007|Baseline|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
11050698|NCT01307020|BG008|Baseline|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
11050699|NCT01307020|BG009|Baseline|Placebo|Placebo oral film-coated tablet, once
11050700|NCT01307020|BG010|Baseline|Total|Total of all reporting groups
11050701|NCT01307020|FG000|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
11050702|NCT01307020|FG001|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
11050703|NCT01307020|FG002|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
11050704|NCT01307020|FG003|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
11050705|NCT01307020|FG004|Participant Flow|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
11050706|NCT01307020|FG005|Participant Flow|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
11050707|NCT01307020|FG006|Participant Flow|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
11050708|NCT01307020|FG007|Participant Flow|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
11050709|NCT01307020|FG008|Participant Flow|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
11050710|NCT01307020|FG009|Participant Flow|Placebo|Placebo oral film-coated tablet, once
11050711|NCT01307020|OG000|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
11050712|NCT01307020|OG001|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
11050713|NCT01307020|OG002|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
11050714|NCT01307020|OG003|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
11050715|NCT01307020|OG004|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
11050716|NCT01307020|OG005|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
11050717|NCT01307020|OG006|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
11050718|NCT01307020|OG007|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
11050719|NCT01307020|OG008|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
11050720|NCT01307020|OG009|Outcome|Placebo|Placebo oral film-coated tablet, once
11050721|NCT01307020|EG000|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
11050722|NCT01307020|EG001|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
11050723|NCT01307020|EG002|Reported Event|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
11050724|NCT01307020|EG003|Reported Event|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
11050725|NCT01307020|EG004|Reported Event|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
11050726|NCT01307020|EG005|Reported Event|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
11050727|NCT01307020|EG006|Reported Event|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
11050728|NCT01307020|EG007|Reported Event|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
11050729|NCT01307020|EG008|Reported Event|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
11050730|NCT01307020|EG009|Reported Event|Placebo|Placebo oral film-coated tablet, once
11050731|NCT01307098|BG000|Baseline|Sebelipase Alfa 0.35 mg/kg|Cohort 1: Participants were administered qw infusions of 0.35 mg/kg sebelipase alfa.
11050732|NCT01307098|BG001|Baseline|Sebelipase Alfa 1 mg/kg|Cohort 2: Participants were administered qw infusions of 1 mg/kg sebelipase alfa.
11050733|NCT01307098|BG002|Baseline|Sebelipase Alfa 3 mg/kg|Cohort 3: Participants were administered qw infusions of 3 mg/kg sebelipase alfa.
11050734|NCT01307098|BG003|Baseline|Total|Total of all reporting groups
11050735|NCT01307098|FG000|Participant Flow|Sebelipase Alfa 0.35 mg/kg|Cohort 1: Participants were administered once weekly (qw) infusions of 0.35 milligrams/kilogram (mg/kg) sebelipase alfa.
11050736|NCT01307098|FG001|Participant Flow|Sebelipase Alfa 1 mg/kg|Cohort 2: Participants were administered qw infusions of 1 mg/kg sebelipase alfa.
11050737|NCT01307098|FG002|Participant Flow|Sebelipase Alfa 3 mg/kg|Cohort 3: Participants were administered qw infusions of 3 mg/kg sebelipase alfa.
11050738|NCT01307098|OG000|Outcome|Sebelipase Alfa 0.35 mg/kg|Cohort 1: Participants were administered qw infusions of 0.35 mg/kg sebelipase alfa.
11050739|NCT01307098|OG001|Outcome|Sebelipase Alfa 1 mg/kg|Cohort 2: Participants were administered qw infusions of 1 mg/kg sebelipase alfa.
11050740|NCT01307098|OG002|Outcome|Sebelipase Alfa 3 mg/kg|Cohort 3: Participants were administered qw infusions of 3 mg/kg sebelipase alfa.
11050741|NCT01307098|EG000|Reported Event|Sebelipase Alfa 0.35 mg/kg|Cohort 1: Participants were administered qw infusions of 0.35 mg/kg sebelipase alfa.
11050742|NCT01307098|EG001|Reported Event|Sebelipase Alfa 1 mg/kg|Cohort 2: Participants were administered qw infusions of 1 mg/kg sebelipase alfa.
11050743|NCT01307098|EG002|Reported Event|Sebelipase Alfa 3 mg/kg|Cohort 3: Participants were administered qw infusions of 3 mg/kg sebelipase alfa.
11050744|NCT01307111|BG000|Baseline|Misoprostol|Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.
11050745|NCT01307111|BG001|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
11050746|NCT01307111|BG002|Baseline|Not Randomized|Women not eligible to continue to randomization.
11050747|NCT01307111|BG003|Baseline|Total|Total of all reporting groups
11050748|NCT01307111|FG000|Participant Flow|Misoprostol|"Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.~Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion."
11050749|NCT01307111|FG001|Participant Flow|Placebo|"Pills which are identical to the study drug in appearance, taste, and smell.~Placebo: Pills which are identical to the study drug in appearance, taste, and smell."
11050750|NCT01307111|OG000|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
11050751|NCT01307111|OG001|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
11050752|NCT01307111|EG000|Reported Event|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
11050753|NCT01307111|EG001|Reported Event|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
11050754|NCT01307267|BG000|Baseline|Portion A: PF-05082566 0.006mg/kg|Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050755|NCT01307267|BG001|Baseline|Portion A: PF-05082566 0.03mg/kg|Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050756|NCT01307267|BG002|Baseline|Portion A: PF-05082566 0.06mg/kg|Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050757|NCT01307267|BG003|Baseline|Portion A: PF-05082566 0.12mg/kg|Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050758|NCT01307267|BG004|Baseline|Portion A: PF-05082566 0.18mg/kg|Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050759|NCT01307267|BG005|Baseline|Portion A: PF-05082566 0.24mg/kg|Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050760|NCT01307267|BG006|Baseline|Portion A: PF-05082566 0.3mg/kg|Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050761|NCT01307267|BG007|Baseline|Portion A: PF-05082566 0.6mg/kg|Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050762|NCT01307267|BG008|Baseline|Portion A: PF-05082566 1.2mg/kg|Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050763|NCT01307267|BG009|Baseline|Portion A: PF-05082566 2.4mg/kg|Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050764|NCT01307267|BG010|Baseline|Portion A: PF-05082566 5mg/kg|Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050765|NCT01307267|BG011|Baseline|Portion A: PF-05082566 10mg/kg|Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050766|NCT01307267|BG012|Baseline|Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050767|NCT01307267|BG013|Baseline|Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050768|NCT01307267|BG014|Baseline|Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050769|NCT01307267|BG015|Baseline|Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050770|NCT01307267|BG016|Baseline|Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050771|NCT01307267|BG017|Baseline|Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050772|NCT01307267|BG018|Baseline|Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050773|NCT01307267|BG019|Baseline|Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050774|NCT01307267|BG020|Baseline|Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050775|NCT01307267|BG021|Baseline|Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050776|NCT01307267|BG022|Baseline|Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050777|NCT01307267|BG023|Baseline|Total|Total of all reporting groups
11050778|NCT01307267|FG000|Participant Flow|Portion A: PF-05082566 0.006mg/kg|Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050779|NCT01307267|FG001|Participant Flow|Portion A: PF-05082566 0.03mg/kg|Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050780|NCT01307267|FG002|Participant Flow|Portion A: PF-05082566 0.06mg/kg|Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050781|NCT01307267|FG003|Participant Flow|Portion A: PF-05082566 0.12mg/kg|Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050782|NCT01307267|FG004|Participant Flow|Portion A: PF-05082566 0.18mg/kg|Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050783|NCT01307267|FG005|Participant Flow|Portion A: PF-05082566 0.24mg/kg|Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050784|NCT01307267|FG006|Participant Flow|Portion A: PF-05082566 0.3mg/kg|Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050785|NCT01307267|FG007|Participant Flow|Portion A: PF-05082566 0.6mg/kg|Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050786|NCT01307267|FG008|Participant Flow|Portion A: PF-05082566 1.2mg/kg|Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050787|NCT01307267|FG009|Participant Flow|Portion A: PF-05082566 2.4mg/kg|Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050788|NCT01307267|FG010|Participant Flow|Portion A: PF-05082566 5mg/kg|Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050789|NCT01307267|FG011|Participant Flow|Portion A: PF-05082566 10mg/kg|Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050790|NCT01307267|FG012|Participant Flow|Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050791|NCT01307267|FG013|Participant Flow|Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050792|NCT01307267|FG014|Participant Flow|Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050793|NCT01307267|FG015|Participant Flow|Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050794|NCT01307267|FG016|Participant Flow|Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050795|NCT01307267|FG017|Participant Flow|Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050796|NCT01307267|FG018|Participant Flow|Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050797|NCT01307267|FG019|Participant Flow|Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050798|NCT01307267|FG020|Participant Flow|Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050799|NCT01307267|FG021|Participant Flow|Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050800|NCT01307267|FG022|Participant Flow|Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050801|NCT01307267|OG000|Outcome|Portion A: PF-05082566 0.006mg/kg|Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050802|NCT01307267|OG001|Outcome|Portion A: PF-05082566 0.03mg/kg|Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050803|NCT01307267|OG002|Outcome|Portion A: PF-05082566 0.06mg/kg|Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050804|NCT01307267|OG003|Outcome|Portion A: PF-05082566 0.12mg/kg|Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050805|NCT01307267|OG004|Outcome|Portion A: PF-05082566 0.18mg/kg|Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050806|NCT01307267|OG005|Outcome|Portion A: PF-05082566 0.24mg/kg|Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050807|NCT01307267|OG006|Outcome|Portion A: PF-05082566 0.3mg/kg|Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050808|NCT01307267|OG007|Outcome|Portion A: PF-05082566 0.6mg/kg|Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050809|NCT01307267|OG008|Outcome|Portion A: PF-05082566 1.2mg/kg|Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050810|NCT01307267|OG009|Outcome|Portion A: PF-05082566 2.4mg/kg|Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050811|NCT01307267|OG010|Outcome|Portion A: PF-05082566 5mg/kg|Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050812|NCT01307267|OG011|Outcome|Portion A: PF-05082566 10mg/kg|Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050813|NCT01307267|OG000|Outcome|Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050814|NCT01307267|OG001|Outcome|Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050815|NCT01307267|OG002|Outcome|Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050816|NCT01307267|OG003|Outcome|Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050817|NCT01307267|OG004|Outcome|Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050818|NCT01307267|OG005|Outcome|Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050819|NCT01307267|OG006|Outcome|Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050820|NCT01307267|OG007|Outcome|Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050821|NCT01307267|OG008|Outcome|Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050822|NCT01307267|OG009|Outcome|Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050823|NCT01307267|OG010|Outcome|Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050824|NCT01307267|OG012|Outcome|Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050825|NCT01307267|OG013|Outcome|Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050826|NCT01307267|OG014|Outcome|Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050827|NCT01307267|OG015|Outcome|Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050828|NCT01307267|OG016|Outcome|Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050829|NCT01307267|OG017|Outcome|Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050830|NCT01307267|OG018|Outcome|Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050831|NCT01307267|OG019|Outcome|Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050832|NCT01307267|OG020|Outcome|Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050833|NCT01307267|OG021|Outcome|Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050834|NCT01307267|OG022|Outcome|Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050835|NCT01307267|EG000|Reported Event|Portion A: PF-05082566 0.006mg/kg|Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050836|NCT01307267|EG001|Reported Event|Portion A: PF-05082566 0.03mg/kg|Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050837|NCT01307267|EG002|Reported Event|Portion A: PF-05082566 0.06mg/kg|Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050838|NCT01307267|EG003|Reported Event|Portion A: PF-05082566 0.12mg/kg|Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050839|NCT01307267|EG004|Reported Event|Portion A: PF-05082566 0.18mg/kg|Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050840|NCT01307267|EG005|Reported Event|Portion A: PF-05082566 0.24mg/kg|Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050841|NCT01307267|EG006|Reported Event|Portion A: PF-05082566 0.3mg/kg|Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050842|NCT01307267|EG007|Reported Event|Portion A: PF-05082566 0.6mg/kg|Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050843|NCT01307267|EG008|Reported Event|Portion A: PF-05082566 1.2mg/kg|Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050844|NCT01307267|EG009|Reported Event|Portion A: PF-05082566 2.4mg/kg|Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050845|NCT01307267|EG010|Reported Event|Portion A: PF-05082566 5mg/kg|Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050846|NCT01307267|EG011|Reported Event|Portion A: PF-05082566 10mg/kg|Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050847|NCT01307267|EG012|Reported Event|Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050848|NCT01307267|EG013|Reported Event|Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050849|NCT01307267|EG014|Reported Event|Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050850|NCT01307267|EG015|Reported Event|Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050851|NCT01307267|EG016|Reported Event|Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050852|NCT01307267|EG017|Reported Event|Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050853|NCT01307267|EG018|Reported Event|Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050854|NCT01307267|EG019|Reported Event|Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050855|NCT01307267|EG020|Reported Event|Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050856|NCT01307267|EG021|Reported Event|Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050857|NCT01307267|EG022|Reported Event|Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2|Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
11050858|NCT01307319|BG000|Baseline|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
11050859|NCT01307319|BG001|Baseline|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
11050860|NCT01307319|BG002|Baseline|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
11050861|NCT01307319|BG003|Baseline|Total|Total of all reporting groups
11050862|NCT01307319|FG000|Participant Flow|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
11050863|NCT01307319|FG001|Participant Flow|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
11050864|NCT01307319|FG002|Participant Flow|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
11050865|NCT01307319|OG000|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
11050866|NCT01307319|OG001|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
11050867|NCT01307319|OG002|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
11050868|NCT01307319|EG000|Reported Event|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
11050869|NCT01307319|EG001|Reported Event|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
11050870|NCT01307319|EG002|Reported Event|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
11050871|NCT01307397|BG000|Baseline|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death or study termination by the Sponsor.
11050872|NCT01307397|FG000|Participant Flow|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 milligrams (mg) (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death or study termination by the Sponsor.
11050873|NCT01307397|OG000|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death or study termination by the Sponsor.
11050874|NCT01307397|EG000|Reported Event|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death or study termination by the Sponsor.
11050875|NCT01307449|BG000|Baseline|Older Group (60-89) PNEUMOVAX|Older Group (60-89) receiving single dose of PNEUMOVAX
11050876|NCT01307449|BG001|Baseline|Older Group (60-89) PREVNAR|Older Group (60-89) receiving single dose of PREVNAR
11050877|NCT01307449|BG002|Baseline|Younger Group (25-40) PNEUMOVAX|Younger Group (25-40) receiving single dose of PNEUMOVAX
11050878|NCT01307449|BG003|Baseline|Younger Group (25-40) PREVNAR|Younger Group (25-40) receiving single dose of PREVNAR
11050879|NCT01307449|BG004|Baseline|Total|Total of all reporting groups
11050880|NCT01307449|FG000|Participant Flow|Older Group (60-89) PNEUMOVAX|Older Group (60-89) receiving single dose of PNEUMOVAX
11050881|NCT01307449|FG001|Participant Flow|Older Group (60-89) PREVNAR|Older Group (60-89) receiving single dose of PREVNAR
11050882|NCT01307449|FG002|Participant Flow|Younger Group (25-40) PNEUMOVAX|Younger Group (25-40) receiving single dose of PNEUMOVAX
11050883|NCT01307449|FG003|Participant Flow|Younger Group (25-40) PREVNAR|Younger Group (25-40) receiving single dose of PREVNAR
11050884|NCT01307449|OG000|Outcome|Older Group (60-89) on PNEUMOVAX|Participants between the ages of 60-89 received single dose of PNEUMOVAX
11050885|NCT01307449|OG001|Outcome|Older Group (60-89) on PREVNAR|Participants between the ages of 60-89 received single dose of PREVNAR
11050886|NCT01307449|OG002|Outcome|Younger Group (25-40) on PNEUMOVAX|Participants between the ages of 25-40 years received single dose of PNEUMOVAX
11050887|NCT01307449|OG003|Outcome|Younger Group (25-40) on PREVNAR|Participants between the ages of 25-40 years received single dose of PREVNAR
11050888|NCT01307449|EG000|Reported Event|Older Group (60-89) PNEUMOVAX|Participants between the ages of 60-89 received single dose of PNEUMOVAX
11050889|NCT01307449|EG001|Reported Event|Older Group (60-89) PREVNAR|Participants between the ages of 60-89 received single dose of PREVNAR
11050890|NCT01307449|EG002|Reported Event|Younger Group (25-40) PNEUMOVAX|Participants between the ages of 25-40 years received single dose of PNEUMOVAX
11050891|NCT01307449|EG003|Reported Event|Younger Group (25-40) PREVNAR|Participants between the ages of 25-40 years received single dose of PREVNAR
11050892|NCT01307462|BG000|Baseline|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
11050893|NCT01307462|FG000|Participant Flow|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
11050894|NCT01307462|OG000|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
11050895|NCT01307462|EG000|Reported Event|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
11050896|NCT01307501|BG000|Baseline|Cryoablation|Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
11050897|NCT01307501|FG000|Participant Flow|Cryoablation|Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
11050898|NCT01307501|OG000|Outcome|Cryoablation|Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
11050899|NCT01307501|EG000|Reported Event|Cryoablation|Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
11050900|NCT01307579|BG000|Baseline|Arm I (Caspofungin Acetate)|"Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC > 100-500/uL following the nadir or the next chemotherapy course begins.~Caspofungin Acetate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11050901|NCT01307579|BG001|Baseline|Arm II (Fluconazole)|"Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course.~Fluconazole: Given IV or PO~Laboratory Biomarker Analysis: Correlative studies"
11050902|NCT01307579|BG002|Baseline|Total|Total of all reporting groups
11050903|NCT01307579|FG000|Participant Flow|Arm I (Caspofungin Acetate)|"Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC > 100-500/uL following the nadir or the next chemotherapy course begins.~Caspofungin Acetate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11050904|NCT01307579|FG001|Participant Flow|Arm II (Fluconazole)|"Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course.~Fluconazole: Given IV or PO~Laboratory Biomarker Analysis: Correlative studies"
11050905|NCT01307579|OG000|Outcome|Arm I (Caspofungin Acetate)|"Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC > 100-500/uL following the nadir or the next chemotherapy course begins.~Caspofungin Acetate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11050906|NCT01307579|OG001|Outcome|Arm II (Fluconazole)|"Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course.~Fluconazole: Given IV or PO~Laboratory Biomarker Analysis: Correlative studies"
11050907|NCT01307579|EG000|Reported Event|Arm I (Caspofungin Acetate)|"Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC > 100-500/uL following the nadir or the next chemotherapy course begins.~Caspofungin Acetate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11050908|NCT01307579|EG001|Reported Event|Arm II (Fluconazole)|"Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course.~Fluconazole: Given IV or PO~Laboratory Biomarker Analysis: Correlative studies"
11050909|NCT01307618|BG000|Baseline|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
11050910|NCT01307618|BG001|Baseline|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
11050911|NCT01307618|BG002|Baseline|Total|Total of all reporting groups
11050912|NCT01307618|FG000|Participant Flow|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
11050913|NCT01307618|FG001|Participant Flow|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
11050914|NCT01307618|OG000|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
11050915|NCT01307618|OG001|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
11050916|NCT01307618|EG000|Reported Event|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
11050917|NCT01307618|EG001|Reported Event|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
11066737|NCT01393743|EG002|Reported Event|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator's discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
11066738|NCT01393821|BG000|Baseline|Arm A (Menadione)|Patients apply menadione topical lotion BID for 28 days.
11066739|NCT01393821|BG001|Baseline|Arm B (Placebo)|Patients apply topical placebo lotion BID for 28 days.
11066740|NCT01393821|BG002|Baseline|Total|Total of all reporting groups
11066741|NCT01393821|FG000|Participant Flow|Arm A (Menadione)|Patients apply menadione topical lotion BID for 28 days.
11066742|NCT01393821|FG001|Participant Flow|Arm B (Placebo)|Patients apply topical placebo lotion BID for 28 days.
11066743|NCT01393821|OG000|Outcome|Arm A (Menadione)|Patients apply menadione topical lotion BID for 28 days.
11050918|NCT01307748|BG000|Baseline|Stress Reducing Aroma|"aroma with reported stress reducing effects~aroma: Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects"
11050919|NCT01307748|BG001|Baseline|Placebo Aroma 1|"aroma: Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects.~Coconut aroma with pleasant odor but no reported stress-reducing effects"
11050920|NCT01307748|BG002|Baseline|Placebo Aroma 2|"aroma: Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects.~Distilled water: substance with no odor or stress-reducing effects"
11050921|NCT01307748|BG003|Baseline|Total|Total of all reporting groups
11050922|NCT01307748|FG000|Participant Flow|Detectable Placebo Aroma: Coconut|"Detectable placebo aroma:organic virgin coconut (Cocos nucifera) base oil (The Ananda Apothecary, Boulder, CO) diluted in 15 ml of grapeseed carrier oil (Now Foods, Bloomingdale, IL) and mixed until solution appeared clear.~During the visit, three drops of the aroma solution were placed on a 5 x 5 mm cotton pad. The pad was then fixed to a small piece of transparent odor free tape that was attached to the participant's nose so that the pad infused with the aroma came to the midpoint between the participant's nose and upper lip. The cotton pad remained attached until the end of testing portion of the visit, but the aroma was not replenished during the testing."
11050923|NCT01307748|FG001|Participant Flow|Stress Reducing Aroma: Lavender|"One drop (using a dropper) of organic lavender (Lavandula angustifolia) essential oil (Mountain Rose Herbs, Eugene, OR) was diluted in 15 ml of grapeseed carrier oil (Now Foods, Bloomingdale, IL).~During the visit, three drops of the aroma solution were placed on a 5 x 5 mm cotton pad. The pad was then fixed to a small piece of transparent odor free tape that was attached to the participant's nose so that the pad infused with the aroma came to the midpoint between the participant's nose and upper lip. The cotton pad remained attached until the end of testing portion of the visit, but the aroma was not replenished during the testing."
11050924|NCT01307748|FG002|Participant Flow|Undetectable Placebo Aroma: Water|For the undetectable placebo aroma, distilled water was used to provide the appearance of essential oil while emitting no odor and producing no effects typically attributed to aromatherapy.
11050925|NCT01307748|OG000|Outcome|Stress Reducing Aroma:Lavender|Lavender aroma with reported stress reducing effects
11050926|NCT01307748|OG001|Outcome|Detectable Placebo Aroma: Coconut|Coconut aroma with pleasant detectable smell but without known stress-reducing effects.
11050927|NCT01307748|OG002|Outcome|Undetectable Placebo Aroma: Water|Distilled water: substance without smell or known stress-reducing effects
11050928|NCT01307748|OG000|Outcome|Stress Reducing Aroma: Lavender|Aroma with reported stress reducing effects
11050929|NCT01307748|OG001|Outcome|Detectable Placebo Aroma: Coconut|Coconut: aroma with detectable pleasant smell but without known stress-reducing effects
11050930|NCT01307748|OG002|Outcome|Undetectable Placebo Aroma: Water|Distilled water: substance with no smell or known stress-reducing effects.
11050931|NCT01307748|OG000|Outcome|Stress Reducing Aroma: Lavender|Aroma with reported stress reducing effects.
11050932|NCT01307748|OG001|Outcome|Detectable Placebo Aroma: Coconut|Coconut: aroma with detectable pleasant odor but no reported stress-reducing effects
11050933|NCT01307748|OG002|Outcome|Undetectable Placebo Aroma: Water|Distilled water: substance with no odor or known stress-reducing effects.
11050934|NCT01307748|EG000|Reported Event|Stress Reducing Aroma: Lavender|Aroma with reported stress reducing effects.
11050935|NCT01307748|EG001|Reported Event|Detectablle Placebo Aroma: Coconut|Aroma with pleasant odor but no known stress-reducing effects
11050936|NCT01307748|EG002|Reported Event|Undetectalbe Placebo Aroma: Water|Distilled water: substance with no odor or known stress-reducing effects
11050937|NCT01307891|BG000|Baseline|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
11050938|NCT01307891|BG001|Baseline|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
11050939|NCT01307891|BG002|Baseline|Total|Total of all reporting groups
11050940|NCT01307891|FG000|Participant Flow|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
11050941|NCT01307891|FG001|Participant Flow|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
11050942|NCT01307891|OG000|Outcome|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
11050943|NCT01307891|OG001|Outcome|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
11050944|NCT01307891|EG000|Reported Event|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks.
11066744|NCT01393821|OG001|Outcome|Arm B (Placebo)|Patients apply topical placebo lotion BID for 28 days.
11066745|NCT01393821|EG000|Reported Event|Arm A (Menadione)|Patients apply menadione topical lotion BID for 28 days.
11050945|NCT01307891|EG001|Reported Event|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Patients will have the option to crossover to the combination arm based upon the pre-clinical data. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
11050946|NCT01307930|BG000|Baseline|Anidulafungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Anidulafungin: Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)"
11050947|NCT01307930|FG000|Participant Flow|Anidulafungin|"The study will have 18 participants complete the 72 hour sampling period. Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Anidulafungin: Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)"
11050948|NCT01307930|OG000|Outcome|Anidulafungin|Single dose of 100 mg by IV infusion.
11050949|NCT01307930|EG000|Reported Event|Anidulafungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Anidulafungin: Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)"
11050950|NCT01307956|BG000|Baseline|Treatment (Panitumumab, Chemotherapy, Radiation)|Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
11050951|NCT01307956|FG000|Participant Flow|Treatment (Panitumumab, Chemotherapy, Radiation)|Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
11050952|NCT01307956|OG000|Outcome|Treatment (Panitumumab, Chemotherapy, Radiation)|Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
11050953|NCT01307956|EG000|Reported Event|Treatment (Panitumumab, Chemotherapy, Radiation)|Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
11050954|NCT01308008|BG000|Baseline|Functional Exercise- Home Physical Activity|"On-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with telephonic behavioral support~home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support"
11050955|NCT01308008|BG001|Baseline|Flex and Tone- Home Health Education|"Initial on-site flex and toning program continued on follow-up along with health education~flex and toning health education program: Initial flex and toning program continued on follow-up along with health education"
11050956|NCT01308008|BG002|Baseline|Total|Total of all reporting groups
11050957|NCT01308008|FG000|Participant Flow|Functional Exercise- Home Physical Activity|"Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support~home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support"
11050958|NCT01308008|FG001|Participant Flow|Flex and Tone- Home Health Education|Initial on-site flex and toning program continued on follow-up along with health education
11050959|NCT01308008|OG000|Outcome|Functional Exercise- Home Physical Activity|"Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support~home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support"
11050960|NCT01308008|OG001|Outcome|Flex and Tone- Home Health Education|Initial on-site flex and toning program continued on follow-up along with health education
11050961|NCT01308008|EG000|Reported Event|Functional Exercise- Home Physical Activity|Functional exercise- home physical activity
11050962|NCT01308008|EG001|Reported Event|Flex and Tone- Home Health Education|Flex and tone- health education
11050963|NCT01308060|BG000|Baseline|Botulinum Toxin Type A|"During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo~Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo."
11066746|NCT01393821|EG001|Reported Event|Arm B (Placebo)|Patients apply topical placebo lotion BID for 28 days.
11050964|NCT01308060|BG001|Baseline|Placebo|"During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo~Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo."
11050965|NCT01308060|BG002|Baseline|Total|Total of all reporting groups
11050966|NCT01308060|FG000|Participant Flow|Botulinum Toxin Type A|"During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo~Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.~Part B was open-label, active treatment to all participants up to 1 year. (Therefore, reason withdrawn cannot be specified per group.)"
11050967|NCT01308060|FG001|Participant Flow|Placebo|"During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo~Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.~Part B was open-label, active treatment to all participants up to 1 year. (Therefore, reason withdrawn cannot be specified per group.)"
11050968|NCT01308060|OG000|Outcome|Botulinum Toxin Type A|"During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo~Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo."
11050969|NCT01308060|OG001|Outcome|Placebo|"During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo~Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo."
11050970|NCT01308060|EG000|Reported Event|Botulinum Toxin Type A - Part A|"During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo.~Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo."
11050971|NCT01308060|EG001|Reported Event|Placebo - Part A|During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo.
11050972|NCT01308060|EG002|Reported Event|Botulinum Toxin Type A - Part B|Part B was open-label, active treatment to all participants up to 1 year. The retreatment, or first treatment if randomized to placebo, injection defines for each subject the start of Part B.
11050973|NCT01308294|BG000|Baseline|Group 1: 2 Vaccine Injections in 1 Limb|"9 patients initially planned: patients received peptides with IMP321/LAG-3Ig and Montanide in 2 injections sites at 5 cm distance from each other 2 vaccine injections in same limb (vaccine 1 : NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide)(vaccine 2 : Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in 1 limb: Participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in the same limb at about 5 cm distance from each other."
11050974|NCT01308294|BG001|Baseline|Group 2: 2 Injections in Different Limbs|"9 patients initially planned: patients received the same vaccine in 2 syringes injected each in a distinct limb 2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in different limbs: Participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide.The content of each syringe is injected s.c. in different limbs."
11050975|NCT01308294|BG002|Baseline|Group 3: 2 Injections in Different Limbs|"9 patients initially planned: due to premature trial termination, no patients could be enrolled in this last group. 2 vaccine injections in different limbs; patients of this group should have received the same vaccine but without the MHC class II peptide (MAGE-A3 LP) in 2 syringes injected each in a distinct limb.~2 vaccine injections without MHC class II peptide in different limbs: Participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A peptide with IMP321/LAG-3 ± Montanide."
11050976|NCT01308294|BG003|Baseline|Total|Total of all reporting groups
11050977|NCT01308294|FG000|Participant Flow|Group 1|"2 vaccine injections in same limb (vaccine 1 : NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2 : Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in 1 limb: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in the same limb at about 5 cm distance from each other."
11050978|NCT01308294|FG001|Participant Flow|Group 2|"2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in different limbs: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide.The content of each syringe is injected s.c. in different limbs."
11050979|NCT01308294|FG002|Participant Flow|Group 3|"2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A peptide + IMP321 + Montanide)~2 vaccine injections in different limbs, the vaccine does not contain the MHC class II peptide MAGE-A3-DP4: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A peptide with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in different limbs."
11050980|NCT01308294|OG000|Outcome|Group 1|"2 vaccine injections in same limb (vaccine 1 : NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2 : Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in 1 limb: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in the same limb at about 5 cm distance from each other."
11050981|NCT01308294|OG001|Outcome|Group 2|"2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in different limbs: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide.The content of each syringe is injected s.c. in different limbs."
11050982|NCT01308294|OG002|Outcome|Group 3|"2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A peptide + IMP321 + Montanide)~2 vaccine injections in different limbs, the vaccine does not contain the MHC class II peptide MAGE-A3-DP4: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A peptide with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in different limbs."
11050983|NCT01308294|OG000|Outcome|Group 1: 2 Vaccine Injections in 1 Limb|"9 patients initially planned: patients received peptides with IMP321/LAG-3Ig and Montanide in 2 injections sites at 5 cm distance from each other 2 vaccine injections in same limb (vaccine 1 : NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide)(vaccine 2 : Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in 1 limb: Participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in the same limb at about 5 cm distance from each other."
11050984|NCT01308294|OG001|Outcome|Group 2: 2 Injections in Different Limbs|"9 patients initially planned: patients received the same vaccine in 2 syringes injected each in a distinct limb 2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in different limbs: Participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide.The content of each syringe is injected s.c. in different limbs."
11050985|NCT01308294|OG002|Outcome|Group 3: 2 Injections in Different Limbs|"9 patients initially planned: due to premature trial termination, no patients could be enrolled in this last group. 2 vaccine injections in different limbs; patients of this group should have received the same vaccine but without the MHC class II peptide (MAGE-A3 LP) in 2 syringes injected each in a distinct limb.~2 vaccine injections without MHC class II peptide in different limbs: Participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A peptide with IMP321/LAG-3 ± Montanide."
11050986|NCT01308294|EG000|Reported Event|Group 1|"2 vaccine injections in same limb (vaccine 1 : NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2 : Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in 1 limb: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in the same limb at about 5 cm distance from each other."
11050987|NCT01308294|EG001|Reported Event|Group 2|"2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)~2 vaccine injections in different limbs: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide.The content of each syringe is injected s.c. in different limbs."
11050988|NCT01308294|EG002|Reported Event|Group 3|"2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A peptide + IMP321 + Montanide)~2 vaccine injections in different limbs, the vaccine does not contain the MHC class II peptide MAGE-A3-DP4: All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A peptide with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in different limbs."
11050989|NCT01308424|BG000|Baseline|Matching Placebo|Matching placebo : sublingual dosing for 7 days
11050990|NCT01308424|BG001|Baseline|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
11050991|NCT01308424|BG002|Baseline|Total|Total of all reporting groups
11050992|NCT01308424|FG000|Participant Flow|Baseline Run In|Baseline period to assess eligibility before randomization
11050993|NCT01308424|FG001|Participant Flow|Matching Placebo|Matching placebo : sublingual dosing for 7 days
11050994|NCT01308424|FG002|Participant Flow|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
11050995|NCT01308424|OG000|Outcome|Matching Placebo|Matching placebo : sublingual dosing for 7 days
11050996|NCT01308424|OG001|Outcome|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
11050997|NCT01308424|EG000|Reported Event|Baseline Run In|Baseline period to assess eligibility before randomization
11050998|NCT01308424|EG001|Reported Event|Matching Placebo|Matching placebo : sublingual dosing for 7 days
11050999|NCT01308424|EG002|Reported Event|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
11051000|NCT01308450|BG000|Baseline|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
11051001|NCT01308450|FG000|Participant Flow|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
11066747|NCT01393899|BG000|Baseline|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
11051002|NCT01308450|OG000|Outcome|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
11051003|NCT01308450|EG000|Reported Event|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
11051004|NCT01308463|BG000|Baseline|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
11051005|NCT01308463|FG000|Participant Flow|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
11051006|NCT01308463|OG000|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
11051007|NCT01308463|EG000|Reported Event|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
11051008|NCT01308476|BG000|Baseline|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
11051009|NCT01308476|BG001|Baseline|Control Group|Control group with same medication but not receiving reminder SMS.
11051010|NCT01308476|BG002|Baseline|Total|Total of all reporting groups
11051011|NCT01308476|FG000|Participant Flow|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
11051012|NCT01308476|FG001|Participant Flow|Control Group|Control group with same medication but not receiving reminder SMS.
11051013|NCT01308476|OG000|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
11051014|NCT01308476|OG001|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
11051015|NCT01308476|EG000|Reported Event|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
11051016|NCT01308476|EG001|Reported Event|Control Group|Control group with same medication but not receiving reminder SMS.
11051017|NCT01308567|BG000|Baseline|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051018|NCT01308567|BG001|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051019|NCT01308567|BG002|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051020|NCT01308567|BG003|Baseline|Total|Total of all reporting groups
11051021|NCT01308567|FG000|Participant Flow|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.
11051022|NCT01308567|FG001|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051023|NCT01308567|FG002|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051024|NCT01308567|OG000|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051025|NCT01308567|OG001|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051026|NCT01308567|OG002|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051027|NCT01308567|EG000|Reported Event|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051028|NCT01308567|EG001|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051029|NCT01308567|EG002|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
11051030|NCT01308580|BG000|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051031|NCT01308580|BG001|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051032|NCT01308580|BG002|Baseline|Total|Total of all reporting groups
11051033|NCT01308580|FG000|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051034|NCT01308580|FG001|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051035|NCT01308580|OG000|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051036|NCT01308580|OG001|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051037|NCT01308580|OG001|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051038|NCT01308580|EG000|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051039|NCT01308580|EG001|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
11051040|NCT01308619|BG000|Baseline|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
11051041|NCT01308619|BG001|Baseline|Placebo|placebo
11051042|NCT01308619|BG002|Baseline|Total|Total of all reporting groups
11051043|NCT01308619|FG000|Participant Flow|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules for 12 weeks
11051044|NCT01308619|FG001|Participant Flow|Placebo Capsules|Placebo capsules for 12 weeks
11051045|NCT01308619|OG000|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
11051046|NCT01308619|OG001|Outcome|Placebo|placebo
11051047|NCT01308619|OG000|Outcome|Treatment Success|
11051048|NCT01308619|OG001|Outcome|Treatment Failure|
11051049|NCT01308619|EG000|Reported Event|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
11051050|NCT01308619|EG001|Reported Event|Placebo|placebo
11051051|NCT01308736|BG000|Baseline|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
11051052|NCT01308736|BG001|Baseline|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
11051053|NCT01308736|BG002|Baseline|Total|Total of all reporting groups
11051054|NCT01308736|FG000|Participant Flow|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
11051055|NCT01308736|FG001|Participant Flow|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
11051056|NCT01308736|OG000|Outcome|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
11051057|NCT01308736|OG001|Outcome|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
11051058|NCT01308736|EG000|Reported Event|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
11051059|NCT01308736|EG001|Reported Event|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
11051060|NCT01308749|BG000|Baseline|Sequence 2:Placebo-oxytocin|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
11051061|NCT01308749|BG001|Baseline|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24 international units (IU). Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
11051062|NCT01308749|BG002|Baseline|Total|Total of all reporting groups
11051063|NCT01308749|FG000|Participant Flow|Sequence 1: Oxytocin-oxytocin|8 weeks of double blind oxytocin followed by 8 weeks of open label oxytocin
11051064|NCT01308749|FG001|Participant Flow|jSequence 2: Placebo-oxytocin|8 weeks of of double blind placebo followed by 8 weeks of open-label oxytocin; this is the control group
11051065|NCT01308749|OG000|Outcome|Sequence 2: Placebo:Oxytocin|Intervention: Drug: placebo double blind for 8 weeks then oxytocin open label for 8 weeks
11051066|NCT01308749|OG001|Outcome|Sequence 1: Oxytocin:Oxytocin|"Intervention: Drug: oxytocin = Syntocinon® Nasal Spray~total of 16 weeks exposure Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
11051067|NCT01308749|OG000|Outcome|Sequence 2: Placebo:Oxytocin|This is accounts for participants from week 0 to week 16. All participants first received placebo (week 0 to week 8) and then subsequently received oxytocin (week 8 to week 16)
11051068|NCT01308749|OG001|Outcome|Sequence 2: Oxytocin:Oxytocin|This accounts for all participants starting from baseline to week 16 who received oxytocin the whole time. All participants participants received oxytocin for the full 16 weeks.
11051069|NCT01308749|OG000|Outcome|Sequence 2: Placebo:Oxytocin|"sequence2: placebo:oxytocin~Placebo: Placebo Nasal Spray"
11051070|NCT01308749|OG001|Outcome|Sequence 1: Oxytocin:Oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
11051071|NCT01308749|OG000|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
11051072|NCT01308749|OG001|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
11051073|NCT01308749|OG001|Outcome|Sequence 2: Placebo :Oxytocin|placebo x8 weeks then oxytocin x 8weeks
11051074|NCT01308749|OG000|Outcome|Sequence 1: Oxytocin-oxytocin|8 weeks of Intervention: Drug: oxytocin (Syntocinon) baseline to week 8
11051075|NCT01308749|OG001|Outcome|Sequence 2: Placebo :Oxytocin|Subjects who received 8 weeks of placebo treatment (baseline to week 8)
11051076|NCT01308749|OG000|Outcome|Sequence 1: Oxytocin-oxytocin|8 weeks of Intervention following randomization
11051077|NCT01308749|OG001|Outcome|Sequence 2: Placebo :Oxytocin|8 weeks double blind placebo followed by 8 wks open label oxytocin
11051078|NCT01308749|OG001|Outcome|Sequence 2: Placebo :Oxytocin|8 weeks of intervention following randomization
11051079|NCT01308749|EG000|Reported Event|Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
11051080|NCT01308749|EG001|Reported Event|Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
11051081|NCT01308749|EG002|Reported Event|Sequence 1: Oxytocin:Oxytocin Period 2, Weeks 8-16|evaluates longer term adverse events with oxytocin
11051082|NCT01308749|EG003|Reported Event|Sequence 2: Placebo:Oxytocin Period 2|evaluates acute exposure to oxytocin in sequence 2 participants
11051083|NCT01308762|BG000|Baseline|Group 1|IMM-101 0.1 mg
11051084|NCT01308762|BG001|Baseline|Group 2|IMM-101 0.5 mg
11051085|NCT01308762|BG002|Baseline|Group 3|IMM-101 1.0 mg
11051086|NCT01308762|BG003|Baseline|Total|Total of all reporting groups
11051087|NCT01308762|FG000|Participant Flow|IMM-101 0.1 mg|Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
11051088|NCT01308762|FG001|Participant Flow|IMM-101 0.5 mg|Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
11051089|NCT01308762|FG002|Participant Flow|IMM-101 1.0 mg|Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
11051090|NCT01308762|OG000|Outcome|IMM-101 0.1 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
11051091|NCT01308762|OG001|Outcome|IMM-101 0.5 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
11051092|NCT01308762|OG002|Outcome|IMM-101 1.0 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
11051093|NCT01308762|OG000|Outcome|Group 1|IMM-101 0.1 mg
11051094|NCT01308762|OG001|Outcome|Group 2|IMM-101 0.5 mg
11051095|NCT01308762|OG002|Outcome|Group 3|IMM-101 1.0 mg
11051096|NCT01308762|EG000|Reported Event|Group 1|IMM-101 0.1 mg
11051097|NCT01308762|EG001|Reported Event|Group 2|IMM-101 0.5 mg
11051098|NCT01308762|EG002|Reported Event|Group 3|IMM-101 1.0 mg
11051099|NCT01308788|BG000|Baseline|Aqueous Suppressant|aqueous suppressant treated
11051100|NCT01308788|BG001|Baseline|Aqueous Outflow|aqueous outflow treated
11051101|NCT01308788|BG002|Baseline|Total|Total of all reporting groups
11051102|NCT01308788|FG000|Participant Flow|Aqueous Outflow|aqueous outflow treated
11051103|NCT01308788|FG001|Participant Flow|Aqueous Suppressant|aqueous suppressant treated
11051104|NCT01308788|OG000|Outcome|Aqueous Outflow|aqueous outflow treated
11051105|NCT01308788|OG001|Outcome|Aqueous Suppressant|aqueous suppressant treated
11051106|NCT01308788|EG000|Reported Event|Aqueous Outflow|aqueous outflow treated
11051107|NCT01308788|EG001|Reported Event|Aqueous Suppressant|aqueous suppressant treated
11051108|NCT01308814|BG000|Baseline|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
11051109|NCT01308814|BG001|Baseline|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
11051110|NCT01308814|BG002|Baseline|Total|Total of all reporting groups
11051111|NCT01308814|FG000|Participant Flow|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
11051112|NCT01308814|FG001|Participant Flow|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
11051113|NCT01308814|OG000|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
11051114|NCT01308814|OG001|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
11051115|NCT01308814|EG000|Reported Event|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
11051116|NCT01308814|EG001|Reported Event|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
11051117|NCT01308840|BG000|Baseline|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
11051118|NCT01308840|FG000|Participant Flow|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
11051119|NCT01308840|OG000|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
11051120|NCT01308840|EG000|Reported Event|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
11051121|NCT01308853|BG000|Baseline|Macrolane|"Open label~Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast."
11051122|NCT01308853|FG000|Participant Flow|Macrolane|"Open label~Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast."
11051123|NCT01308853|OG000|Outcome|Macrolane|"Open label~Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast."
11051124|NCT01308853|EG000|Reported Event|Macrolane|"Open label~Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast."
11051125|NCT01308918|BG000|Baseline|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
11051126|NCT01308918|FG000|Participant Flow|GlideScope DLT Intubation With GlideRite DLT Stylet|The double lumen tube (DLT) is the technique of choice to obtain lung isolation. The GlideScope® (GLS, video laryngoscope allowing vizualisation of the airway and tube placement, has been used with a high level of success to assist positioning a single lumen tube (SLT) in normal situations and mainly in situations where the airway is considered or proven to be difficult.We have designed a new semi-rigid intubating stylet, the GlideRite DLT Stylet® (GR-DLT-S), which can be used for primary DLT intubation with the GLS. This pilot study was planned to observe the efficiency and the safety of the GR-DLT-S for primary insertion of DLT with the GLS in patients presenting a normal superior airway. After obtaining local IRB approval, 50 patients scheduled for thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy at l'Institut de cardiologie et de pneumologie de Québec, were enrolled in this observational study.
11051127|NCT01308918|OG000|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
11051128|NCT01308918|EG000|Reported Event|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
11051129|NCT01309100|BG000|Baseline|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
11051130|NCT01309100|FG000|Participant Flow|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
11051131|NCT01309100|OG000|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens (RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
11051132|NCT01309100|OG001|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.~Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
11051133|NCT01309100|OG000|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
11051134|NCT01309100|OG001|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.~Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
11226519|NCT02375984|BG000|Baseline|Tumor Infiltrating Lymphocytes (TIL)|"Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro either as part of this treatment protocol or the JWCI procurement protocol. TIL from these cultures will be assessed for tumor-reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day X 2 days IV) and fludarabine (25 mg/m2/day IV X 5 days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 109 tumor-reactive lymphocytes (TIL) followed by high-dose intravenous IL-2 (600-720,000 IU/kg/dose every 8 hours for up to 12 doses).~Tumor Infiltrating Lymphocytes (TIL): Patients will receive an IV adoptive transfer of at least 10^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down."
11226520|NCT02375984|FG000|Participant Flow|Tumor Infiltrating Lymphocytes (TIL)|"Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro either as part of this treatment protocol or the JWCI procurement protocol. TIL from these cultures will be assessed for tumor-reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day X 2 days IV) and fludarabine (25 mg/m2/day IV X 5 days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 109 tumor-reactive lymphocytes (TIL) followed by high-dose intravenous IL-2 (600-720,000 IU/kg/dose every 8 hours for up to 12 doses).~Tumor Infiltrating Lymphocytes (TIL): Patients will receive an IV adoptive transfer of at least 10^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down."
11226521|NCT02375984|OG000|Outcome|Tumor Infiltrating Lymphocytes (TIL)|"Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro either as part of this treatment protocol or the JWCI procurement protocol. TIL from these cultures will be assessed for tumor-reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day X 2 days IV) and fludarabine (25 mg/m2/day IV X 5 days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 109 tumor-reactive lymphocytes (TIL) followed by high-dose intravenous IL-2 (600-720,000 IU/kg/dose every 8 hours for up to 12 doses).~Tumor Infiltrating Lymphocytes (TIL): Patients will receive an IV adoptive transfer of at least 10^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down."
11226522|NCT02375984|EG000|Reported Event|Tumor Infiltrating Lymphocytes (TIL)|"Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro either as part of this treatment protocol or the JWCI procurement protocol. TIL from these cultures will be assessed for tumor-reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day X 2 days IV) and fludarabine (25 mg/m2/day IV X 5 days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 109 tumor-reactive lymphocytes (TIL) followed by high-dose intravenous IL-2 (600-720,000 IU/kg/dose every 8 hours for up to 12 doses).~Tumor Infiltrating Lymphocytes (TIL): Patients will receive an IV adoptive transfer of at least 10^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down."
11226523|NCT02376010|BG000|Baseline|Rivaroxaban|"rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)~rivaroxaban"
11226524|NCT02376010|BG001|Baseline|Warfarin|"warfarin orally once a day, titrated to INR of 2-3~Warfarin"
11226525|NCT02376010|BG002|Baseline|Total|Total of all reporting groups
11226526|NCT02376010|FG000|Participant Flow|Rivaroxaban|"rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)~rivaroxaban"
11226527|NCT02376010|FG001|Participant Flow|Warfarin|"warfarin orally once a day, titrated to INR of 2-3~Warfarin"
11226528|NCT02376010|OG000|Outcome|Rivaroxaban|"rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)~rivaroxaban"
11226529|NCT02376010|OG001|Outcome|Warfarin|"warfarin orally once a day, titrated to INR of 2-3~Warfarin"
11226530|NCT02376010|EG000|Reported Event|Rivaroxaban|"rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)~rivaroxaban"
11051135|NCT01309100|EG000|Reported Event|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
11066748|NCT01393899|BG001|Baseline|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
11066749|NCT01393899|BG002|Baseline|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
11226531|NCT02376010|EG001|Reported Event|Warfarin|"warfarin orally once a day, titrated to INR of 2-3~Warfarin"
11226532|NCT02376166|BG000|Baseline|Metformin|850 mg PO once daily for 4 weeks
11226533|NCT02376166|FG000|Participant Flow|Metformin|"850 mg PO once daily for 4 weeks~Metformin: 850 mg PO twice daily for the remainder of the study period (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)"
11226534|NCT02376166|OG000|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
11226535|NCT02376166|EG000|Reported Event|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
11051136|NCT01309165|BG000|Baseline|CO-OP|CO-OP: CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10-session intervention format. The client and the therapist work together, using the Canadian Occupational Performance Measure (COPM), to select 3 skills and establish baseline skill performance. In the second meeting, when CO-OP actually begins, the approach is introduced to the client and the global cognitive strategy (GOAL-PLAN-DO-CHECK) is learned. In all subsequent sessions this strategy is used as the main problem-solving framework to facilitate skill acquisition.Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
11051137|NCT01309165|BG001|Baseline|Standard Occupational Therapy|Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
11051138|NCT01309165|BG002|Baseline|Total|Total of all reporting groups
11051139|NCT01309165|FG000|Participant Flow|CO-OP|CO-OP: CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10-session intervention format. The client and the therapist work together, using the Canadian Occupational Performance Measure (COPM), to select 3 skills and establish baseline skill performance. In the second meeting, when CO-OP actually begins, the approach is introduced to the client and the global cognitive strategy (GOAL-PLAN-DO-CHECK) is learned. In all subsequent sessions this strategy is used as the main problem-solving framework to facilitate skill acquisition.Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
11051140|NCT01309165|FG001|Participant Flow|Standard Occupational Therapy|Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
11051141|NCT01309165|OG000|Outcome|CO-OP|CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10 one-hour sessions intervention format. Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
11051142|NCT01309165|OG001|Outcome|Standard Occupational Therapy|"Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.~Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy."
11051143|NCT01309165|OG000|Outcome|CO-OP|CO-OP: CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10-session intervention format. The client and the therapist work together, using the Canadian Occupational Performance Measure (COPM), to select 3 skills and establish baseline skill performance. In the second meeting, when CO-OP actually begins, the approach is introduced to the client and the global cognitive strategy (GOAL-PLAN-DO-CHECK) is learned. In all subsequent sessions this strategy is used as the main problem-solving framework to facilitate skill acquisition.Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
11051144|NCT01309165|EG000|Reported Event|CO-OP|CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10 one-hour sessions intervention format. Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
11051145|NCT01309165|EG001|Reported Event|Standard Occupational Therapy|"Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.~Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy."
11051146|NCT01309204|BG000|Baseline|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
11051147|NCT01309204|BG001|Baseline|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
11051148|NCT01309204|BG002|Baseline|Total|Total of all reporting groups
11226536|NCT02376179|BG000|Baseline|Cuffed ETT|"Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.~Cuffed ETT"
11051149|NCT01309204|FG000|Participant Flow|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
11051150|NCT01309204|FG001|Participant Flow|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
11051151|NCT01309204|OG000|Outcome|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
11051152|NCT01309204|OG001|Outcome|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
11051153|NCT01309204|EG000|Reported Event|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
11051154|NCT01309204|EG001|Reported Event|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
11051155|NCT01309243|BG000|Baseline|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
11051156|NCT01309243|BG001|Baseline|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
11051157|NCT01309243|BG002|Baseline|Total|Total of all reporting groups
11051158|NCT01309243|FG000|Participant Flow|FTC/RPV/TDF|Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
11051159|NCT01309243|FG001|Participant Flow|EFV/FTC/TDF|Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
11051160|NCT01309243|OG000|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
11051161|NCT01309243|OG001|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
11051162|NCT01309243|EG000|Reported Event|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
11051163|NCT01309243|EG001|Reported Event|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
11051164|NCT01309269|BG000|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
11051165|NCT01309269|FG000|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
11051166|NCT01309269|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
11051167|NCT01309269|EG000|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
11051168|NCT01309282|BG000|Baseline|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
11051169|NCT01309282|FG000|Participant Flow|Rituximab|Participants with sero-positive [Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (CCP+)] rheumatoid arthritis (RA), who had commenced therapy with rituximab (MabThera) following lack of response or intolerance to a single tumor necrosis factor (TNF)-inhibitor were included in this arm.
11051170|NCT01309282|OG000|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
11051171|NCT01309282|EG000|Reported Event|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
11051172|NCT01309308|BG000|Baseline|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
11051173|NCT01309308|BG001|Baseline|No Sweeping Group|The patients who did not have sweeping of the membranes
11051174|NCT01309308|BG002|Baseline|Total|Total of all reporting groups
11051175|NCT01309308|FG000|Participant Flow|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
11051176|NCT01309308|FG001|Participant Flow|No Sweeping Group|The patients who did not have sweeping of the membranes
11051177|NCT01309308|OG000|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
11051178|NCT01309308|OG001|Outcome|Not Swept|Patients whose membranes are not swept
11051179|NCT01309308|EG000|Reported Event|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
11051180|NCT01309308|EG001|Reported Event|No Sweeping Group|The patients who did not have sweeping of the membranes
11051181|NCT01309360|BG000|Baseline|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
11051182|NCT01309360|BG001|Baseline|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
11051183|NCT01309360|BG002|Baseline|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
11051184|NCT01309360|BG003|Baseline|Total|Total of all reporting groups
11051185|NCT01309360|FG000|Participant Flow|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
11051186|NCT01309360|FG001|Participant Flow|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
11051187|NCT01309360|FG002|Participant Flow|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
11051188|NCT01309360|OG000|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
11051189|NCT01309360|OG001|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
11051190|NCT01309360|OG002|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
11051191|NCT01309360|EG000|Reported Event|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
11051192|NCT01309360|EG001|Reported Event|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
11051193|NCT01309360|EG002|Reported Event|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
11051194|NCT01309386|BG000|Baseline|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
11051195|NCT01309386|BG001|Baseline|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
11051196|NCT01309386|BG002|Baseline|Total|Total of all reporting groups
11051197|NCT01309386|FG000|Participant Flow|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
11051198|NCT01309386|FG001|Participant Flow|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
11051199|NCT01309386|OG000|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
11051200|NCT01309386|OG001|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
11051201|NCT01309386|EG000|Reported Event|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
11051202|NCT01309386|EG001|Reported Event|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
11051203|NCT01309451|BG000|Baseline|Bevacizumab Alone|Bevacizumab only
11051204|NCT01309451|BG001|Baseline|Combine Group|Bevacizumab plus Ozurdex
11051205|NCT01309451|BG002|Baseline|Total|Total of all reporting groups
11051206|NCT01309451|FG000|Participant Flow|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
11051207|NCT01309451|FG001|Participant Flow|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
11051208|NCT01309451|OG000|Outcome|Bevacizumab Alone|Bevacizumab: intravitreal, 1.25mg., monthly
11051209|NCT01309451|OG001|Outcome|Combined Group|"Bevacizumab plus Ozurdex~Bevacizumab: intravitreal, 1.25mg., monthly~dexamethasone intravitreal implant: 0.7mg, intravitreal every 4 months"
11051210|NCT01309451|OG000|Outcome|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
11051211|NCT01309451|OG001|Outcome|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
11051212|NCT01309451|EG000|Reported Event|Bevacizumab Alone Group|bevacizumab 1.25mg intravitreally
11051213|NCT01309451|EG001|Reported Event|Combined Group|bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other.
11051214|NCT01309646|BG000|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
11051215|NCT01309646|BG001|Baseline|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
11051216|NCT01309646|BG002|Baseline|Total|Total of all reporting groups
11051217|NCT01309646|FG000|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
11066750|NCT01393899|BG003|Baseline|Total|Total of all reporting groups
11066751|NCT01393899|FG000|Participant Flow|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
11051218|NCT01309646|FG001|Participant Flow|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
11051219|NCT01309646|OG000|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
11051220|NCT01309646|OG001|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
11051221|NCT01309646|EG000|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
11051222|NCT01309646|EG001|Reported Event|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
11051223|NCT01309659|BG000|Baseline|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
11051224|NCT01309659|BG001|Baseline|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
11051225|NCT01309659|BG002|Baseline|Total|Total of all reporting groups
11051226|NCT01309659|FG000|Participant Flow|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
11051227|NCT01309659|FG001|Participant Flow|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
11051228|NCT01309659|OG000|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
11051229|NCT01309659|OG001|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
11051230|NCT01309659|EG000|Reported Event|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
11051231|NCT01309659|EG001|Reported Event|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
11051232|NCT01309737|BG000|Baseline|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051233|NCT01309737|BG001|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051234|NCT01309737|BG002|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
11051235|NCT01309737|BG003|Baseline|Total|Total of all reporting groups
11051236|NCT01309737|FG000|Participant Flow|CP-690,550 5mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
11051237|NCT01309737|FG001|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051238|NCT01309737|FG002|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
11051239|NCT01309737|FG003|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051240|NCT01309737|FG004|Participant Flow|Placebo,CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051241|NCT01309737|OG000|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051242|NCT01309737|OG001|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051243|NCT01309737|OG002|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
11051244|NCT01309737|OG000|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051245|NCT01309737|OG001|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051246|NCT01309737|OG002|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051247|NCT01309737|OG003|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051248|NCT01309737|OG002|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051249|NCT01309737|OG003|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051250|NCT01309737|OG002|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051251|NCT01309737|OG003|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051252|NCT01309737|OG000|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051253|NCT01309737|OG001|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051254|NCT01309737|OG003|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051255|NCT01309737|OG003|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051256|NCT01309737|OG003|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051257|NCT01309737|EG000|Reported Event|CP-690,550 5mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Week 52.
11051258|NCT01309737|EG001|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051259|NCT01309737|EG002|Reported Event|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
11051260|NCT01309737|EG003|Reported Event|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
11051261|NCT01309737|EG004|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
11051262|NCT01309802|BG000|Baseline|Placebo|no intervention
11051263|NCT01309802|BG001|Baseline|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
11051264|NCT01309802|BG002|Baseline|Total|Total of all reporting groups
11051265|NCT01309802|FG000|Participant Flow|Placebo|no intervention
11051266|NCT01309802|FG001|Participant Flow|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
11051267|NCT01309802|OG000|Outcome|Placebo|no intervention
11051268|NCT01309802|OG001|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
11051269|NCT01309802|EG000|Reported Event|Placebo|no intervention
11051270|NCT01309802|EG001|Reported Event|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
11051271|NCT01309828|BG000|Baseline|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
11051272|NCT01309828|BG001|Baseline|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
11051273|NCT01309828|BG002|Baseline|Total|Total of all reporting groups
11051274|NCT01309828|FG000|Participant Flow|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
11051275|NCT01309828|FG001|Participant Flow|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
11051276|NCT01309828|OG000|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
11051277|NCT01309828|OG001|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
11051278|NCT01309828|EG000|Reported Event|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
11051279|NCT01309828|EG001|Reported Event|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
11051280|NCT01309841|BG000|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
11051281|NCT01309841|BG001|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11051282|NCT01309841|BG002|Baseline|Placebo|Placebo QD, oral treatment
11051283|NCT01309841|BG003|Baseline|Total|Total of all reporting groups
11051284|NCT01309841|FG000|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
11051285|NCT01309841|FG001|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11051286|NCT01309841|FG002|Participant Flow|Placebo|Placebo QD, oral treatment
11051287|NCT01309841|OG000|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
11051288|NCT01309841|OG001|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11051289|NCT01309841|OG002|Outcome|Placebo|Placebo QD, oral treatment
11051290|NCT01309841|EG000|Reported Event|NKTR-118 12.5 mg|
11051291|NCT01309841|EG001|Reported Event|NKTR-118 25 mg|
11051292|NCT01309841|EG002|Reported Event|Placebo|
11051293|NCT01309867|BG000|Baseline|All Participants|Participants were randomized 1:1 to receive test contact lenses or control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.
11051294|NCT01309867|FG000|Participant Flow|Investigational Toric Lens Then PureVision Toric Lens|"Bausch + Lomb investigational toric contact lenses~Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.~Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks."
11051295|NCT01309867|FG001|Participant Flow|PureVision Toric Lens Then Investigational Toric Lens|"Currently marketed Bausch + Lomb PureVision toric contact lenses~PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.~Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks."
11051296|NCT01309867|OG000|Outcome|Investigational Toric Lens|"Bausch + Lomb investigational toric contact lenses~Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks."
11051297|NCT01309867|OG001|Outcome|PureVision Toric Lens|"Currently marketed Bausch + Lomb PureVision toric contact lenses~PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks."
11051298|NCT01309867|EG000|Reported Event|Investigational Toric Lens|"Bausch + Lomb investigational toric contact lenses~Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks."
11051299|NCT01309867|EG001|Reported Event|PureVision Toric Lens|"Currently marketed Bausch + Lomb PureVision toric contact lenses~PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks."
11051300|NCT01309880|BG000|Baseline|Overall Study|One-half of the participants (33) were randomized to receive the investigational RD2117-01 ID4 contact lens, and the other half (33) was randomized to receive the Air Optix Aqua contact lens. Both groups wore the lenses on a daily wear basis. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.
11066752|NCT01393899|FG001|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
11051301|NCT01309880|FG000|Participant Flow|Air Optix Aqua Then Test Lens|Ciba Vision Air Optix Aqua contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to the Test lens. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
11051302|NCT01309880|FG001|Participant Flow|Test Lens Then Air Optix Aqua|The test lens was an Investigational silicone hydrogel contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to Ciba Vision Air Optix Aqua contact lens.. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
11051303|NCT01309880|OG000|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
11051304|NCT01309880|OG001|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
11051305|NCT01309880|EG000|Reported Event|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
11051306|NCT01309880|EG001|Reported Event|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
11051307|NCT01309893|BG000|Baseline|Entire Study Population|All eligible enrolled participants
11051308|NCT01309893|FG000|Participant Flow|Investigational Lens First, Then Air Optix Aqua Lens|Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked.
11051309|NCT01309893|FG001|Participant Flow|Air Optix Aqua Lens First, Then Investigational Lens|Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked.
11051310|NCT01309893|OG000|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
11051311|NCT01309893|OG001|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
11051312|NCT01309893|EG000|Reported Event|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
11051313|NCT01309893|EG001|Reported Event|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
11051314|NCT01309906|BG000|Baseline|Overall|All participants received both treatment groups.
11051315|NCT01309906|FG000|Participant Flow|Investigational Lens Then Air Optix Aqua Lens|"Bausch & Lomb investigational silicone hydrogel lens~Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.~Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week."
11051316|NCT01309906|FG001|Participant Flow|Air Optix Aqua Lens Then Investigational Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.~Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week."
11051317|NCT01309906|OG000|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens~Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week."
11051318|NCT01309906|OG001|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week."
11051319|NCT01309906|EG000|Reported Event|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens~Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week."
11051320|NCT01309906|EG001|Reported Event|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week."
11051321|NCT01309919|BG000|Baseline|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
11051322|NCT01309919|BG001|Baseline|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
11051323|NCT01309919|BG002|Baseline|Total|Total of all reporting groups
11051324|NCT01309919|FG000|Participant Flow|Intrauterine Device (IUD) Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
11051325|NCT01309919|FG001|Participant Flow|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
11051326|NCT01309919|OG000|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
11066753|NCT01393899|FG002|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
11051327|NCT01309919|OG001|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
11051328|NCT01309919|EG000|Reported Event|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
11051329|NCT01309919|EG001|Reported Event|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
11051330|NCT01309997|BG000|Baseline|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
11051331|NCT01309997|BG001|Baseline|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. TDuring the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
11051332|NCT01309997|BG002|Baseline|Total|Total of all reporting groups
11051333|NCT01309997|FG000|Participant Flow|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
11051334|NCT01309997|FG001|Participant Flow|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
11051335|NCT01309997|OG000|Outcome|Arm I (Enzyme Inhibitor)|Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
11051336|NCT01309997|OG001|Outcome|Arm II (Monoclonal Antibody)|Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
11051337|NCT01309997|OG000|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate as their first therapy. They may take this from 1 mo-18 mo.
11051338|NCT01309997|OG001|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
11051339|NCT01309997|OG000|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
11051340|NCT01309997|OG000|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
11051341|NCT01309997|OG001|Outcome|Arm II (Monocolonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
11051342|NCT01309997|OG000|Outcome|Rituximab Responders|Attained a SCR with rituximab
11051343|NCT01309997|OG001|Outcome|Rituximab Non-responders|Did not attain a SCR with rituximab
11051344|NCT01309997|OG002|Outcome|Imatinib Responders|Attained a SCR with imatinib
11051345|NCT01309997|OG003|Outcome|Imatinib Nonresponders|Did not attain a SCR with imatinib
11051346|NCT01309997|EG000|Reported Event|Imatinib as Initial Therapy|Arm I = imatinib, adverse event occurred after the start date of imatinib and if applicable, prior to start date of rituximab.
11051347|NCT01309997|EG001|Reported Event|Rituximab as Initial Therapy|Arm I = rituximab, adverse event occurred after the start date of rituximab and if applicable, prior to start date of imatinib.
11051348|NCT01309997|EG002|Reported Event|Imatinib as Secondary Therapy|Arm II = imatinib, adverse event occurred after the start date of imatinib. (All participants in this group received rituximab prior).
11051349|NCT01309997|EG003|Reported Event|Rituximab as Secondary Therapy|Arm II = rituximab, adverse event occurred after the start date of rituximab. (All participants in this group received imatinib prior).
11051350|NCT01310036|BG000|Baseline|Erlotinib|Erlotinib 150 mg daily
11051351|NCT01310036|FG000|Participant Flow|Erlotinib|Erlotinib 150 mg daily
11051352|NCT01310036|OG000|Outcome|Erlotinib|Erlotinib 150 mg daily
11051353|NCT01310036|EG000|Reported Event|Erlotinib|Erlotinib 150 mg daily
11051354|NCT01310075|BG000|Baseline|Arm 1|Surgimend
11051355|NCT01310075|BG001|Baseline|Arm 2|Alloderm
11051356|NCT01310075|BG002|Baseline|Total|Total of all reporting groups
11051357|NCT01310075|FG000|Participant Flow|Arm 1- Surgimend|Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.
11051358|NCT01310075|FG001|Participant Flow|Arm 2-Alloderm|"Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.~Device: Alloderm 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the"
11051359|NCT01310075|OG000|Outcome|Arm 1|Surgimend
11051360|NCT01310075|OG001|Outcome|Arm 2|Alloderm
11051361|NCT01310075|EG000|Reported Event|Arm 1|Surgimend
11051362|NCT01310075|EG001|Reported Event|Arm 2|Alloderm
11051363|NCT01310127|BG000|Baseline|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
11051364|NCT01310127|BG001|Baseline|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
11051365|NCT01310127|BG002|Baseline|Total|Total of all reporting groups
11051366|NCT01310127|FG000|Participant Flow|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
11051367|NCT01310127|FG001|Participant Flow|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
11051368|NCT01310127|OG000|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
11051369|NCT01310127|OG001|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
11051370|NCT01310127|EG000|Reported Event|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
11051371|NCT01310127|EG001|Reported Event|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
11051372|NCT01310179|BG000|Baseline|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
11051373|NCT01310179|FG000|Participant Flow|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
11051374|NCT01310179|OG000|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
11051375|NCT01310179|EG000|Reported Event|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days..~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
11051376|NCT01310231|BG000|Baseline|Metformin|"Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Number of cycles: Until progression or unacceptable toxicity develops."
11051377|NCT01310231|BG001|Baseline|Placebo|"Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Number of cycles: until progression or unacceptable toxicity develops."
11051378|NCT01310231|BG002|Baseline|Total|Total of all reporting groups
11051379|NCT01310231|FG000|Participant Flow|Metformin|"Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Number of cycles: Until progression or unacceptable toxicity develops."
11051380|NCT01310231|FG001|Participant Flow|Placebo|"Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Number of cycles: until progression or unacceptable toxicity develops."
11051381|NCT01310231|OG000|Outcome|Metformin|"Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Number of cycles: Until progression or unacceptable toxicity develops."
11051382|NCT01310231|OG001|Outcome|Placebo|"Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Number of cycles: until progression or unacceptable toxicity develops."
11051383|NCT01310231|EG000|Reported Event|Metformin|"Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Number of cycles: Until progression or unacceptable toxicity develops."
11051384|NCT01310231|EG001|Reported Event|Placebo|"Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).~Number of cycles: until progression or unacceptable toxicity develops."
11051385|NCT01310400|BG000|Baseline|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
11051386|NCT01310400|BG001|Baseline|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
11051387|NCT01310400|BG002|Baseline|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
11051388|NCT01310400|BG003|Baseline|Total|Total of all reporting groups
11051389|NCT01310400|FG000|Participant Flow|Inflexal V 0.5 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
11051390|NCT01310400|FG001|Participant Flow|Inflexal V 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
11051391|NCT01310400|FG002|Participant Flow|Agrippal 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
11051392|NCT01310400|OG000|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
11051393|NCT01310400|OG001|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
11051394|NCT01310400|OG002|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
11051395|NCT01310400|OG000|Outcome|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
11051396|NCT01310400|OG001|Outcome|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
11051397|NCT01310400|OG002|Outcome|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
11051398|NCT01310400|EG000|Reported Event|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
11051399|NCT01310400|EG001|Reported Event|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
11051400|NCT01310400|EG002|Reported Event|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
11051401|NCT01310413|BG000|Baseline|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051402|NCT01310413|BG001|Baseline|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051403|NCT01310413|BG002|Baseline|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051404|NCT01310413|BG003|Baseline|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11226537|NCT02376179|FG000|Participant Flow|Cuffed ETT|Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
11051405|NCT01310413|BG004|Baseline|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051406|NCT01310413|BG005|Baseline|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051407|NCT01310413|BG006|Baseline|Total|Total of all reporting groups
11051408|NCT01310413|FG000|Participant Flow|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051409|NCT01310413|FG001|Participant Flow|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11226538|NCT02376179|OG000|Outcome|Cuffed ETT|"Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.~Cuffed ETT"
11051410|NCT01310413|FG002|Participant Flow|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051411|NCT01310413|FG003|Participant Flow|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051412|NCT01310413|FG004|Participant Flow|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051413|NCT01310413|FG005|Participant Flow|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051414|NCT01310413|FG006|Participant Flow|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
11051415|NCT01310413|OG000|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051416|NCT01310413|OG001|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051417|NCT01310413|OG002|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051418|NCT01310413|OG003|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051419|NCT01310413|OG004|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051420|NCT01310413|OG005|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051421|NCT01310413|OG001|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|SSubjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051422|NCT01310413|OG003|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051423|NCT01310413|OG001|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051424|NCT01310413|OG002|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051425|NCT01310413|OG000|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051426|NCT01310413|OG001|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051427|NCT01310413|OG000|Outcome|Placebo/Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
11051428|NCT01310413|OG000|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051429|NCT01310413|OG000|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
11051430|NCT01310413|OG000|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11066754|NCT01393899|OG000|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
11066755|NCT01393899|OG001|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
11066756|NCT01393899|OG002|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
11066757|NCT01393899|OG000|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
11066758|NCT01393899|OG001|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
11051431|NCT01310413|OG000|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
11051432|NCT01310413|OG000|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051433|NCT01310413|OG000|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
11051434|NCT01310413|OG001|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051435|NCT01310413|OG001|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051436|NCT01310413|OG000|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and PInfluenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051437|NCT01310413|OG000|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
11066759|NCT01393899|EG000|Reported Event|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
11066760|NCT01393899|EG001|Reported Event|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
11066761|NCT01393899|EG002|Reported Event|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
11226539|NCT02376179|EG000|Reported Event|Cuffed ETT|Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
11226540|NCT02376257|BG000|Baseline|250 mg DCS|"Baseline assessment (week 1), two weekly sessions when 250mg DCS is administered, and final week (week 4) when retention is assessed.~250 mg DCS: Drug"
11226541|NCT02376257|BG001|Baseline|100 mg Modafinil|"Baseline assessment (week 1), two weekly sessions when 100 mg modafinil is administered, and final week (week 4) when retention is assessed.~100 mg Modafinil: Drug"
11051438|NCT01310413|OG000|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
11051439|NCT01310413|EG000|Reported Event|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051440|NCT01310413|EG001|Reported Event|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
11051441|NCT01310413|EG002|Reported Event|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
11051442|NCT01310582|BG000|Baseline|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
11051443|NCT01310582|BG001|Baseline|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
11051444|NCT01310582|BG002|Baseline|Total|Total of all reporting groups
11051445|NCT01310582|FG000|Participant Flow|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
11051446|NCT01310582|FG001|Participant Flow|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
11051447|NCT01310582|OG000|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
11051448|NCT01310582|OG001|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
11051449|NCT01310582|EG000|Reported Event|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
11051450|NCT01310582|EG001|Reported Event|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
11051451|NCT01310699|BG000|Baseline|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051452|NCT01310699|BG001|Baseline|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11226542|NCT02376257|BG002|Baseline|Placebo|"Baseline assessment (week 1), two weekly sessions when placebo is administered, and final week (week 4) when retention is assessed.~Placebo: Drug"
11051453|NCT01310699|BG002|Baseline|Total|Total of all reporting groups
11226543|NCT02376257|BG003|Baseline|Total|Total of all reporting groups
11226544|NCT02376257|FG000|Participant Flow|250 mg DCS|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~250 mg DCS: Drug"
11051454|NCT01310699|FG000|Participant Flow|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051455|NCT01310699|FG001|Participant Flow|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051456|NCT01310699|OG000|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051457|NCT01310699|OG001|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051458|NCT01310699|OG000|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051459|NCT01310699|OG001|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051460|NCT01310699|EG000|Reported Event|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051461|NCT01310699|EG001|Reported Event|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
11051462|NCT01310777|BG000|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
11051463|NCT01310777|BG001|Baseline|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
11051464|NCT01310777|BG002|Baseline|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
11051465|NCT01310777|BG003|Baseline|Total|Total of all reporting groups
11051466|NCT01310777|FG000|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
11051467|NCT01310777|FG001|Participant Flow|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
11051468|NCT01310777|FG002|Participant Flow|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
11051469|NCT01310777|OG000|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
11051470|NCT01310777|OG001|Outcome|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
11051471|NCT01310777|OG002|Outcome|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
11226545|NCT02376257|FG001|Participant Flow|100 mg Modafinil|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~100 mg Modafinil: Drug"
11051472|NCT01310777|EG000|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
11226546|NCT02376257|FG002|Participant Flow|Placebo|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~Placebo: Drug"
11226547|NCT02376257|OG000|Outcome|250 mg DCS|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~250 mg DCS: Drug"
11226548|NCT02376257|OG001|Outcome|100 mg Modafinil|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~100 mg Modafinil: Drug"
11051473|NCT01310777|EG001|Reported Event|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
11051474|NCT01310777|EG002|Reported Event|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
11051475|NCT01310855|BG000|Baseline|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
11051476|NCT01310855|BG001|Baseline|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
11051477|NCT01310855|BG002|Baseline|Total|Total of all reporting groups
11051478|NCT01310855|FG000|Participant Flow|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
11226549|NCT02376257|OG002|Outcome|Placebo|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~Placebo: Drug"
11226550|NCT02376257|EG000|Reported Event|250 mg DCS|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~250 mg DCS: Drug"
11051479|NCT01310855|FG001|Participant Flow|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
11051480|NCT01310855|OG000|Outcome|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
11051481|NCT01310855|OG001|Outcome|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
11051482|NCT01310855|EG000|Reported Event|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~Due to the early discontinuation of Cediranib by AZ, the trial was discontinued early so that only 38 patients (19 per arm) were recruited. One patient in the Cediranib arm did not complete their patient diary, and it was not known how much of the trial treatment they had. Therefore the adverse events reported by the patient could not be attributed to the trial treatment and they were excluded from all analyses."
11051483|NCT01310855|EG001|Reported Event|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~Due to the early discontinuation of Cediranib by AZ, the trial was discontinued early so that only 38 patients (19 per arm) were recruited."
11051484|NCT01310868|BG000|Baseline|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
11051485|NCT01310868|FG000|Participant Flow|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
11051486|NCT01310868|OG000|Outcome|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
11051487|NCT01310868|EG000|Reported Event|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
11051488|NCT01311024|BG000|Baseline|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
11051489|NCT01311024|BG001|Baseline|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
11051490|NCT01311024|BG002|Baseline|Total|Total of all reporting groups
11226551|NCT02376257|EG001|Reported Event|100 mg Modafinil|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~100 mg Modafinil: Drug"
11226552|NCT02376257|EG002|Reported Event|Placebo|"Randomized drug intervention was administered on two weekly sessions following baseline evaluation~Placebo: Drug"
11226553|NCT02376283|BG000|Baseline|Clopidogrel|"STEMI (n = 14) and NSTEMI (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11051491|NCT01311024|FG000|Participant Flow|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
11051492|NCT01311024|FG001|Participant Flow|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
11051493|NCT01311024|OG000|Outcome|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
11051494|NCT01311024|OG001|Outcome|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
11051495|NCT01311024|EG000|Reported Event|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
11051496|NCT01311024|EG001|Reported Event|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
11051497|NCT01311102|BG000|Baseline|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
11051498|NCT01311102|BG001|Baseline|Normal Saline|Normal Saline : 1.33cc of normal saline
11051499|NCT01311102|BG002|Baseline|Total|Total of all reporting groups
11051500|NCT01311102|FG000|Participant Flow|Lidocaine|Lidocaine : 1.33 cc of 2% liquid lidocaine
11051501|NCT01311102|FG001|Participant Flow|Normal Saline|Normal Saline : 1.33cc of normal saline
11051502|NCT01311102|OG000|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
11051503|NCT01311102|OG001|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
11051504|NCT01311102|OG000|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium
11051505|NCT01311102|OG001|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline infused in endo cervix and endometrium.
11051506|NCT01311102|EG000|Reported Event|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
11051507|NCT01311102|EG001|Reported Event|Normal Saline|Normal Saline : 1.33cc of normal saline
11051508|NCT01311362|BG000|Baseline|Ambrisentan|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
11051509|NCT01311362|FG000|Participant Flow|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
11051510|NCT01311362|OG000|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
11051511|NCT01311362|OG001|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
11051512|NCT01311362|OG002|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg t.i.d. on day 11-20
11051513|NCT01311362|OG002|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
11051514|NCT01311362|EG000|Reported Event|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
11051515|NCT01311362|EG001|Reported Event|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
11051516|NCT01311362|EG002|Reported Event|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
11051517|NCT01311505|BG000|Baseline|Participants Eligible for Analysis|Includes participants randomized to receive Myrin 2 first and Rimactane first and who had completed the study. It excludes 1 participant who did not meet the weight requirement for the study (protocol violator).
11051518|NCT01311505|FG000|Participant Flow|Myrin 2 First, Then Rimactane|Single oral dose of 2 fixed dose combination (FDC) tablets of Myrin 2 (each tablet contains 150 milligram (mg) rifampicin and 75 mg isoniazid) in first intervention period, and single oral dose of Rimactane capsule (300 mg rifampicin) in second intervention period. A washout period of at least 7 days was maintained between each period.
11051519|NCT01311505|FG001|Participant Flow|Rimactane First, Then Myrin 2|Single oral dose of Rimactane capsule (300 mg rifampicin) in first intervention period; and single oral dose of 2 FDC tablets of Myrin 2 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) in second intervention period. A washout period of at least 7 days was maintained between each period.
11051520|NCT01311505|OG000|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
11051521|NCT01311505|OG001|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
11051522|NCT01311505|OG001|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg capsule) in either first intervention period or second intervention period.
11051523|NCT01311505|OG000|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
11051524|NCT01311505|OG001|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
11051525|NCT01311505|EG000|Reported Event|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
11051526|NCT01311505|EG001|Reported Event|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
11051527|NCT01311557|BG000|Baseline|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
11051528|NCT01311557|BG001|Baseline|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
11051529|NCT01311557|BG002|Baseline|Total|Total of all reporting groups
11051530|NCT01311557|FG000|Participant Flow|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
11051531|NCT01311557|FG001|Participant Flow|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
11051532|NCT01311557|OG000|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
11051533|NCT01311557|OG001|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
11051534|NCT01311557|EG000|Reported Event|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
11051535|NCT01311557|EG001|Reported Event|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
11051536|NCT01311648|BG000|Baseline|Main Study - Part A: PTPs 0-<6 Years|Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.
11051537|NCT01311648|BG001|Baseline|Main Study - Part A: PTPs 6-12 Years|Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.
11051538|NCT01311648|BG002|Baseline|Main Study - Part B: PUPs/MTPs 0-<6 Years|Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
11051539|NCT01311648|BG003|Baseline|Total|Total of all reporting groups
11051540|NCT01311648|FG000|Participant Flow|PTPs 0-12 Years|Previously treated patients (PTPs) aged below 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (EDs) in main study - Part A. Participants having reached at least 50 EDs in main study - Part A were offered participation in an open label extension study (optional). Participants who transitioned from main study - Part A to the extension study received BAY81-8973, 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study).
11051541|NCT01311648|FG001|Participant Flow|PUPs/MTPs 0-<6 Years|Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more than 3 exposure days [EDs] with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for at least 50 EDs or until inhibitor development in main study - Part B. Participants having reached at least 50 EDs in main study - Part B were offered participation in an open label extension study and received BAY81-8973 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study); participants who developed an inhibitor in main study - Part B were offered participation in open label extension study and received Immune Tolerance Induction (ITI) treatment with BAY81-8973 until successful eradication of the inhibitor, or until failure, for approximately 18 months.
11051542|NCT01311648|OG000|Outcome|Main Study - Part A: PTPs 0-<6 Years|Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.
11051543|NCT01311648|OG001|Outcome|Main Study - Part A: PTPs 6-12 Years|Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.
11051544|NCT01311648|OG002|Outcome|Main Study - Part B: PUPs/MTPs 0-<6 Years|Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
11051545|NCT01311648|OG002|Outcome|Main Study - Part B: PUPs/MTPs 0-<6 Years|Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 EDs with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 exposure days (ED) or until inhibitor development in main study - Part B.
11051546|NCT01311648|OG000|Outcome|Extension Study - Former Part A Participants|Participants having reached at least 50 exposure days (EDs) in main study - Part A were offered participation in an open label extension study (optional). Participants who transitioned from main study - Part A to the extension study received BAY81-8973, 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study).
11051547|NCT01311648|OG001|Outcome|Extension Study - Former Part B Participants|Participants having reached at least 50 exposure days (EDs) in main study - Part B were offered participation in an open label extension study and received BAY81-8973 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study); participants who developed an inhibitor in main study - Part B were offered participation in open label extension study and received Immune Tolerance Induction (ITI) treatment with BAY81-8973 until successful eradication of the inhibitor, or until failure, for approximately 18 months.
11051548|NCT01311648|EG000|Reported Event|Main Study - Part A: PTPs 0-<6 Years|Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.
11051549|NCT01311648|EG001|Reported Event|Main Study - Part A: PTPs 6-12 Years|Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.
11051550|NCT01311648|EG002|Reported Event|Main Study - Part B: PUPs/MTPs 0-<6 Years|Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
11051551|NCT01311648|EG003|Reported Event|Extension Study - Former Part A Participants|Participants having reached at least 50 exposure days (EDs) in main study - Part A were offered participation in an open label extension study (optional). Participants who transitioned from main study - Part A to the extension study received BAY81-8973, 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study).
11051552|NCT01311648|EG004|Reported Event|Extension Study - Former Part B Participants|Participants having reached at least 50 exposure days (EDs) in main study - Part B were offered participation in an open label extension study and received BAY81-8973 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study); participants who developed an inhibitor in main study - Part B were offered participation in open label extension study and received Immune Tolerance Induction (ITI) treatment with BAY81-8973 until successful eradication of the inhibitor, or until failure, for approximately 18 months.
11051553|NCT01311661|BG000|Baseline|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
11051554|NCT01311661|FG000|Participant Flow|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
11051555|NCT01311661|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
11051556|NCT01311661|OG001|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
11051557|NCT01311661|OG002|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
11051558|NCT01311661|OG003|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
11051559|NCT01311661|OG004|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
11051560|NCT01311661|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
11051561|NCT01311661|EG001|Reported Event|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
11051562|NCT01311661|EG002|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
11051563|NCT01311661|EG003|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
11051564|NCT01311661|EG004|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
11051565|NCT01311674|BG000|Baseline|Schedule 1- Standard Dose Primary Vaccination Series|"Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)~hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL"
11051566|NCT01311674|BG001|Baseline|Schedule 2 - High Dose Primary Vaccination Series|"Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)~hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL"
11051567|NCT01311674|BG002|Baseline|Total|Total of all reporting groups
11051568|NCT01311674|FG000|Participant Flow|Schedule 1 - Standard Dose Primary Vaccination Series|hepatitis B vaccine: Primary vaccination series 20 ug/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 ug/1.0 mL every 4 months
11051569|NCT01311674|FG001|Participant Flow|Schedule 2 - High Dose Primary Vaccination Series|hepatitis B vaccine: Primary vaccination series 40 ug/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 ug/1.0 mL every 4 months
11051570|NCT01311674|OG000|Outcome|Schedule 1- Standard Dose Primary Vaccination Series|"Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)~hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL"
11051571|NCT01311674|OG001|Outcome|Schedule 2 - High Dose Primary Vaccination Series|"Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)~hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL"
11051572|NCT01311674|OG001|Outcome|Schedule 2 - High Dose Primary Vaccination Series|"Schedule 1 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)~hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL"
11051573|NCT01311674|EG000|Reported Event|Schedule 1- Standard Dose Primary Vaccination Series|"Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)~hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL"
11051574|NCT01311674|EG001|Reported Event|Schedule 2 - High Dose Primary Vaccination Series|"Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)~hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL"
11051575|NCT01311687|BG000|Baseline|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
11051576|NCT01311687|BG001|Baseline|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
11051577|NCT01311687|BG002|Baseline|Total|Total of all reporting groups
11051578|NCT01311687|FG000|Participant Flow|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
11051579|NCT01311687|FG001|Participant Flow|High-Dose Dexamethasone (HD-Dex)|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
11051580|NCT01311687|OG000|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
11051581|NCT01311687|OG001|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
11051582|NCT01311687|OG001|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression, or until cross-over to pomalidomide. Data are up to the time of cross-over.
11051583|NCT01311687|OG002|Outcome|HD-Dex / Pomalidomide|Participants initially randomized to high-dose dexamethasone (HD-Dex) crossed over to receive 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle, with or without low-dose dexamethasone (40 mg for participants ≤ 75 years or 20 mg for participants > 75 years of age, administered orally once per day on Days 1, 8, 15, and 22 of each 28-day cycle) at the discretion of the investigator. Data include AEs that occurred after cross-over to pomalidomide.
11051584|NCT01311687|EG000|Reported Event|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
11051585|NCT01311687|EG001|Reported Event|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression, or until cross-over to pomalidomide. Data are up to the time of cross-over.
11051586|NCT01311687|EG002|Reported Event|HD-Dex / Pomalidomide|Participants initially randomized to high-dose dexamethasone (HD-Dex) crossed over to receive 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle, with or without low-dose dexamethasone (40 mg for participants ≤ 75 years or 20 mg for participants > 75 years of age, administered orally once per day on Days 1, 8, 15, and 22 of each 28-day cycle) at the discretion of the investigator. Data include AEs that occurred after cross-over to pomalidomide.
11051587|NCT01311895|BG000|Baseline|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone~H2O: 2 mg IV hydromorphone"
11051588|NCT01311895|BG001|Baseline|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
11051589|NCT01311895|BG002|Baseline|Total|Total of all reporting groups
11051590|NCT01311895|FG000|Participant Flow|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone~H2O: 2 mg intravenous (IV) hydromorphone"
11051591|NCT01311895|FG001|Participant Flow|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg intravenous (IV) hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
11051592|NCT01311895|OG000|Outcome|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone administered over 2-3 minutes as initial dose~H2O: 2 mg IV hydromorphone"
11051593|NCT01311895|OG001|Outcome|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
11051594|NCT01311895|EG000|Reported Event|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone~H2O: 2 mg IV hydromorphone"
11051595|NCT01311895|EG001|Reported Event|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
11051596|NCT01312038|BG000|Baseline|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
11051597|NCT01312038|BG001|Baseline|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
11051598|NCT01312038|BG002|Baseline|Total|Total of all reporting groups
11051599|NCT01312038|FG000|Participant Flow|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
11051600|NCT01312038|FG001|Participant Flow|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
11051601|NCT01312038|OG000|Outcome|Simethicone-treated|Outcome measure in each evaluable ear.
11051602|NCT01312038|OG001|Outcome|Placebo|Outcome measure in each evaluable ear
11051603|NCT01312038|EG000|Reported Event|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
11051604|NCT01312038|EG001|Reported Event|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
11051605|NCT01312129|BG000|Baseline|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
11051606|NCT01312129|BG001|Baseline|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
11051607|NCT01312129|BG002|Baseline|Total|Total of all reporting groups
11051608|NCT01312129|FG000|Participant Flow|Placebo First, Then Sulfasalzine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
11051609|NCT01312129|FG001|Participant Flow|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
11051610|NCT01312129|OG000|Outcome|Placebo|Placebo x 3 doses 12 hours apart
11051611|NCT01312129|OG001|Outcome|Sulfasalazine|Sulfasalazine capsule, 500mg, x 3 doses 12 hours.
11051612|NCT01312129|EG000|Reported Event|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
11051613|NCT01312129|EG001|Reported Event|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
11051614|NCT01312181|BG000|Baseline|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051615|NCT01312181|BG001|Baseline|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051616|NCT01312181|BG002|Baseline|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051617|NCT01312181|BG003|Baseline|Total|Total of all reporting groups
11051618|NCT01312181|FG000|Participant Flow|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051619|NCT01312181|FG001|Participant Flow|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051620|NCT01312181|FG002|Participant Flow|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051621|NCT01312181|OG000|Outcome|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051622|NCT01312181|OG001|Outcome|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051623|NCT01312181|OG002|Outcome|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051624|NCT01312181|EG000|Reported Event|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051625|NCT01312181|EG001|Reported Event|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051626|NCT01312181|EG002|Reported Event|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
11051627|NCT01312233|BG000|Baseline|Shared Care|"Co-management of medical care and chiropractic care~Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care."
11051628|NCT01312233|BG001|Baseline|Dual Care|"Unlinked co-occurrence of conventional medical care and chiropractic care~Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided."
11051629|NCT01312233|BG002|Baseline|Medical Care|"Conventional medical care alone~Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral."
11051630|NCT01312233|BG003|Baseline|Total|Total of all reporting groups
11051631|NCT01312233|FG000|Participant Flow|Shared Care|"Co-management of medical care and chiropractic care~Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care."
11051632|NCT01312233|FG001|Participant Flow|Dual Care|"Unlinked co-occurrence of conventional medical care and chiropractic care~Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided."
11051633|NCT01312233|FG002|Participant Flow|Medical Care|"Conventional medical care alone~Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral."
11051634|NCT01312233|OG000|Outcome|Shared Care|"Co-management of medical care and chiropractic care~Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care."
11051635|NCT01312233|OG001|Outcome|Dual Care|"Unlinked co-occurrence of conventional medical care and chiropractic care~Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided."
11051636|NCT01312233|OG002|Outcome|Medical Care|"Conventional medical care alone~Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral."
11051637|NCT01312233|EG000|Reported Event|Shared Care|"Co-management of medical care and chiropractic care~Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care."
11051638|NCT01312233|EG001|Reported Event|Dual Care|"Unlinked co-occurrence of conventional medical care and chiropractic care~Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided."
11051639|NCT01312233|EG002|Reported Event|Medical Care|"Conventional medical care alone~Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral."
11051640|NCT01312272|BG000|Baseline|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
11051641|NCT01312272|BG001|Baseline|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
11051642|NCT01312272|BG002|Baseline|Total|Total of all reporting groups
11051643|NCT01312272|FG000|Participant Flow|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
11051644|NCT01312272|FG001|Participant Flow|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
11051645|NCT01312272|OG000|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
11051646|NCT01312272|OG001|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
11051647|NCT01312272|EG000|Reported Event|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
11051648|NCT01312272|EG001|Reported Event|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
11051649|NCT01312389|BG000|Baseline|Phase 1|3 patients will be enrolled receiving the vaccine (tumor lysate/Montanide) plus Ampligen using a 3+3 approach. If no DLTs in the first three subjects, we will move to phase II; if one 1/3 subject develops DLTs, we will enroll 3 additional subjects; if 2/6 subjects develop DLTs, we will discontinue the study. Following completion of run---in phase I (3 or 6 subjects), we will transition to Phase 2.
11051650|NCT01312389|BG001|Baseline|Phase 2, Arm A|"10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions.~OC-L/Montanide ISA 51 VG: All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.~Ampligen: All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.~Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness."
11051651|NCT01312389|BG002|Baseline|Phase 2, Arm B|"10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions, administered in combination with intravenous Ampligen.~OC-L/Montanide ISA 51 VG: All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.~Ampligen: All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.~Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness."
11051652|NCT01312389|BG003|Baseline|Total|Total of all reporting groups
11051653|NCT01312389|FG000|Participant Flow|Phase 1|3 patients will be enrolled receiving the vaccine (tumor lysate/Montanide) plus Ampligen using a 3+3 approach. If no DLTs in the first three subjects, we will move to phase II; if one 1/3 subject develops DLTs, we will enroll 3 additional subjects; if 2/6 subjects develop DLTs, we will discontinue the study. Following completion of run---in phase I (3 or 6 subjects), we will transition to Phase 2.
11051654|NCT01312389|FG001|Participant Flow|Phase 2, Arm A|"10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions.~OC-L/Montanide ISA 51 VG: All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.~Ampligen: All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.~Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness."
11051655|NCT01312389|FG002|Participant Flow|Phase 2, Arm B|"10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions, administered in combination with intravenous Ampligen.~OC-L/Montanide ISA 51 VG: All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.~Ampligen: All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.~Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness."
11051656|NCT01312389|OG000|Outcome|Phase 1|3 patients will be enrolled receiving the vaccine (tumor lysate/Montanide) plus Ampligen using a 3+3 approach. If no DLTs in the first three subjects, we will move to phase II; if one 1/3 subject develops DLTs, we will enroll 3 additional subjects; if 2/6 subjects develop DLTs, we will discontinue the study. Following completion of run---in phase I (3 or 6 subjects), we will transition to Phase 2.
11349014|NCT04131517|BG000|Baseline|Part 1 Sequence A|Participants received padsevonil (PSL) tablets 100 milligrams (mg) up-titrated to 400 mg, orally twice daily (bid) from Day 1 to 6 followed by padsevonil 400 mg bid on Day 7 to 14 along with a single dose of oral contraceptive (OC) Microgynon® 30 (ethinylestradiol 30 microgram [mcg] + levonorgestrel 150 mcg) tablet on Day 13 and, then padsevonil down-titrated from 400 mg to 100 mg bid from Day 15 to 19 during first Treatment Period. Participants received a single dose of OC tablet on Day 34 during second Treatment Period. There was a Washout Period of 14 days between the two Treatment Periods.
11051657|NCT01312389|OG001|Outcome|Phase 2, Arm A|"10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions.~OC-L/Montanide ISA 51 VG: All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.~Ampligen: All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.~Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness."
11051658|NCT01312389|OG002|Outcome|Phase 2, Arm B|"10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions, administered in combination with intravenous Ampligen.~OC-L/Montanide ISA 51 VG: All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.~Ampligen: All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.~Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness."
11051659|NCT01312389|EG000|Reported Event|Phase 1|3 patients will be enrolled receiving the vaccine (tumor lysate/Montanide) plus Ampligen using a 3+3 approach. If no DLTs in the first three subjects, we will move to phase II; if one 1/3 subject develops DLTs, we will enroll 3 additional subjects; if 2/6 subjects develop DLTs, we will discontinue the study. Following completion of run---in phase I (3 or 6 subjects), we will transition to Phase 2.
11051660|NCT01312389|EG001|Reported Event|Phase 2, Arm A|"10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions.~OC-L/Montanide ISA 51 VG: All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.~Ampligen: All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.~Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness."
11051661|NCT01312389|EG002|Reported Event|Phase 2, Arm B|"10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions, administered in combination with intravenous Ampligen.~OC-L/Montanide ISA 51 VG: All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.~Ampligen: All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.~Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness."
11051662|NCT01312467|BG000|Baseline|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11051663|NCT01312467|FG000|Participant Flow|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11051664|NCT01312467|OG000|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11051665|NCT01312467|OG000|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride"
11051666|NCT01312467|EG000|Reported Event|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11051667|NCT01312519|BG000|Baseline|Manual Bone Marrow Sampling Device|Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
11051668|NCT01312519|BG001|Baseline|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
11051669|NCT01312519|BG002|Baseline|Total|Total of all reporting groups
10847004|NCT00281580|FG009|Participant Flow|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
11051670|NCT01312519|FG000|Participant Flow|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
11051671|NCT01312519|FG001|Participant Flow|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
11051672|NCT01312519|OG000|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
11051673|NCT01312519|OG001|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
11051674|NCT01312519|EG000|Reported Event|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
11051675|NCT01312519|EG001|Reported Event|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
11226554|NCT02376283|BG001|Baseline|Prasugrel|"STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226555|NCT02376283|BG002|Baseline|Ticagrelor|"STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226556|NCT02376283|BG003|Baseline|Total|Total of all reporting groups
11226557|NCT02376283|FG000|Participant Flow|Clopidogrel|"STEMI (ST-segment elevation myocardial infarction) (n = 14) and NSTEMI (Non-ST segment elevation myocardial infarction) (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226558|NCT02376283|FG001|Participant Flow|Prasugrel|"STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226559|NCT02376283|FG002|Participant Flow|Ticagrelor|"STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226560|NCT02376283|OG000|Outcome|Clopidogrel|"STEMI (n = 14) and NSTEMI (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226561|NCT02376283|OG001|Outcome|Prasugrel|"STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11051676|NCT01312675|BG000|Baseline|Group A|"S.A.F.E.BT plus Standard of Care therapy~S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period."
11051677|NCT01312675|BG001|Baseline|Group B|Standard of Care therapy alone
11051678|NCT01312675|BG002|Baseline|Total|Total of all reporting groups
11051679|NCT01312675|FG000|Participant Flow|Group A|"S.A.F.E.BT plus Standard of Care therapy~S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period."
11051680|NCT01312675|FG001|Participant Flow|Group B|Standard of Care therapy alone
11051681|NCT01312675|OG000|Outcome|Group A|"S.A.F.E.BT plus Standard of Care therapy~S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period."
11051682|NCT01312675|OG001|Outcome|Group B|Standard of Care therapy alone
11051683|NCT01312675|EG000|Reported Event|Group A|"S.A.F.E.BT plus Standard of Care therapy~S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period."
11051684|NCT01312675|EG001|Reported Event|Group B|Standard of Care therapy alone
11051685|NCT01312766|BG000|Baseline|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
11051686|NCT01312766|BG001|Baseline|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
11051687|NCT01312766|BG002|Baseline|Total|Total of all reporting groups
11051688|NCT01312766|FG000|Participant Flow|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
11051689|NCT01312766|FG001|Participant Flow|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
11051690|NCT01312766|OG000|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
11051691|NCT01312766|OG001|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
11051692|NCT01312766|EG000|Reported Event|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
11051693|NCT01312766|EG001|Reported Event|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
11051694|NCT01312779|BG000|Baseline|Magna Mitral 23|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051695|NCT01312779|FG000|Participant Flow|Magna Mitral 23|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051696|NCT01312779|OG000|Outcome|Magna Mitral 23|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051697|NCT01312779|OG000|Outcome|Magna Mitral 23 - >30 Days Post-implant|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051698|NCT01312779|OG001|Outcome|Magna Mitral 23 - 1 Year Post-implant|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051699|NCT01312779|OG002|Outcome|Magna Mitral 23 - 2 Years Post-implant|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051700|NCT01312779|OG003|Outcome|Magna Mitral 23 - 3 Years Post-implant|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051701|NCT01312779|OG004|Outcome|Magna Mitral 23 - 4 Years Post-implant|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051702|NCT01312779|OG005|Outcome|Magna Mitral 23 - 5 Years Post-implant|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051703|NCT01312779|OG000|Outcome|Baseline NYHA - Magna Mitral 23|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051704|NCT01312779|OG001|Outcome|1 Year NYHA - Magna Mitral 23|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051705|NCT01312779|OG000|Outcome|EQ-5D at Baseline|EQ-5D data.Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051706|NCT01312779|EG000|Reported Event|Magna Mitral 23|Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
11051707|NCT01312805|BG000|Baseline|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
11051708|NCT01312805|BG001|Baseline|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
11051709|NCT01312805|BG002|Baseline|Total|Total of all reporting groups
11051710|NCT01312805|FG000|Participant Flow|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
11051711|NCT01312805|FG001|Participant Flow|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
11051712|NCT01312805|OG000|Outcome|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
11051713|NCT01312805|OG001|Outcome|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
11051714|NCT01312805|EG000|Reported Event|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
11051715|NCT01312805|EG001|Reported Event|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
11051716|NCT01312818|BG000|Baseline|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
11051717|NCT01312818|FG000|Participant Flow|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
11051718|NCT01312818|OG000|Outcome|ALL Treated Patients|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
11341936|NCT03693742|FG000|Participant Flow|MSG, Then Placebo|"After a fasting period of 4 hours, participants first received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.~Within 1 week, participants returned and after having fasted for 4 hours, then received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan."
11051719|NCT01312818|OG000|Outcome|ALL Treated Patients|"List of toxicities in acute lymphoblastic leukemia (ALL) patients treated with bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
11051720|NCT01312818|OG000|Outcome|Chemotherapy|"Bortezomib IV Vorinostat PO Dexamethasone PO Intrathecal Methotrexate Imatinib Mesylate PO (for Ph+ ALL patients only)~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
11051721|NCT01312818|EG000|Reported Event|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
11051722|NCT01312844|BG000|Baseline|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
11051723|NCT01312844|BG001|Baseline|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
11051724|NCT01312844|BG002|Baseline|Total|Total of all reporting groups
11051725|NCT01312844|FG000|Participant Flow|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
11051726|NCT01312844|FG001|Participant Flow|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
11051727|NCT01312844|OG000|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
11051728|NCT01312844|OG001|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
11051729|NCT01312844|EG000|Reported Event|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
11051730|NCT01312844|EG001|Reported Event|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
11051731|NCT01312909|BG000|Baseline|Varenicline High Dose|Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
11051732|NCT01312909|BG001|Baseline|Varenicline Low Dose|Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.
11051733|NCT01312909|BG002|Baseline|Placebo|Participants received 2 tablets of placebo (matched to Varenicline) orally, twice daily from Week 2 to Week 12 after a 2-week titration.
11051734|NCT01312909|BG003|Baseline|Total|Total of all reporting groups
11051735|NCT01312909|FG000|Participant Flow|Varenicline High Dose|Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
11051736|NCT01312909|FG001|Participant Flow|Varenicline Low Dose|Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.
11051737|NCT01312909|FG002|Participant Flow|Placebo|Participants received 2 tablets of placebo (matched to Varenicline) orally, twice daily from Week 2 to Week 12 after a 2-week titration.
11051738|NCT01312909|OG000|Outcome|Varenicline High Dose|Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
11149183|NCT01869192|EG000|Reported Event|Arm A|"Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment~Epirubicin: Epirubicin 90 mg/m2 d1 q3w~Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w~Radiation Therapy: Standard dosing, fields depending on clinical findings"
11149184|NCT01869192|EG001|Reported Event|Arm B|"Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment~Docetaxel: Docetaxel 75 mg/m2 d1 q3w~Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w~Radiation Therapy: Standard dosing, fields depending on clinical findings"
11149185|NCT01869348|BG000|Baseline|Wait List Control|This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
11149186|NCT01869348|BG001|Baseline|Monitor Intervention|"This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls~Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
11149187|NCT01869348|BG002|Baseline|Total|Total of all reporting groups
11149188|NCT01869348|FG000|Participant Flow|Wait List Control|This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
11149189|NCT01869348|FG001|Participant Flow|Monitor Intervention|"This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls~Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
11149190|NCT01869348|OG000|Outcome|Wait List Control|This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
11149191|NCT01869348|OG001|Outcome|Monitor Intervention|"This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls~Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
11149192|NCT01869348|EG000|Reported Event|Wait List Control|This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
11149193|NCT01869348|EG001|Reported Event|Monitor Intervention|"This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls~Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
11149194|NCT01869374|BG000|Baseline|Magnetic Seizure Therapy (MST)|"MagVenture MagPro MST device~MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week."
11149195|NCT01869374|BG001|Baseline|Right Unilateral ECT (RUL ECT)|"Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus~RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week."
11149196|NCT01869374|BG002|Baseline|Total|Total of all reporting groups
11149197|NCT01869374|FG000|Participant Flow|Magnetic Seizure Therapy (MST)|"MagVenture MagPro MST device~MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week."
11149198|NCT01869374|FG001|Participant Flow|RUL ECT|"Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus~RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week."
11149199|NCT01869374|OG000|Outcome|Magnetic Seizure Therapy (MST)|"MagVenture MagPro MST device~MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week."
11149200|NCT01869374|OG001|Outcome|RUL ECT|"Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus~RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week."
11149201|NCT01869374|EG000|Reported Event|Magnetic Seizure Therapy (MST)|"MagVenture MagPro MST device~MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week."
11149202|NCT01869374|EG001|Reported Event|RUL ECT|"Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus~RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week."
11051739|NCT01312909|OG001|Outcome|Varenicline Low Dose|Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.
11051740|NCT01312909|OG002|Outcome|Placebo|Participants received 2 tablets of placebo (matched to Varenicline) orally, twice daily from Week 2 to Week 12 after a 2-week titration.
11051741|NCT01312909|EG000|Reported Event|Varenicline High Dose|Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
11051742|NCT01312909|EG001|Reported Event|Varenicline Low Dose|Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.
11051743|NCT01312909|EG002|Reported Event|Placebo|Participants received 2 tablets of placebo (matched to Varenicline) orally, twice daily from Week 2 to Week 12 after a 2-week titration.
11051744|NCT01312948|BG000|Baseline|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
11051745|NCT01312948|FG000|Participant Flow|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
11051746|NCT01312948|OG000|Outcome|Pixi Paediatric Mask Usability|Usability (overall performance) score of the Pixi paediatric mask
11051747|NCT01312948|OG001|Outcome|Usual Mask|Usability (overall performance) score of the child's usual CPAP mask
11051748|NCT01312948|OG000|Outcome|Pixi Paediatric Mask|Apnea hypopnoea index from a monitored sleep study of the new Pixi mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
11051749|NCT01312948|OG001|Outcome|Usual Mask|Apnea hypopnoea index from a monitored sleep study of the child's usual CPAP mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
11051750|NCT01312948|EG000|Reported Event|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
11051751|NCT01312961|BG000|Baseline|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication.
11051752|NCT01312961|BG001|Baseline|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
11051753|NCT01312961|BG002|Baseline|Total|Total of all reporting groups
11051754|NCT01312961|FG000|Participant Flow|Placebo (for Dupilumab)|Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication.
11051755|NCT01312961|FG001|Participant Flow|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
11051756|NCT01312961|OG000|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
11051757|NCT01312961|OG001|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
11051758|NCT01312961|OG000|Outcome|Placebo|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
11051759|NCT01312961|EG000|Reported Event|Placebo (for Dupilumab)|Participants exposed to Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
11051760|NCT01312961|EG001|Reported Event|Dupilumab 300 mg qw|Participants exposed to Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
11051761|NCT01313039|BG000|Baseline|AZD6244|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
11051762|NCT01313039|FG000|Participant Flow|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
11051763|NCT01313039|OG000|Outcome|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
11051764|NCT01313039|EG000|Reported Event|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
11051765|NCT01313078|BG000|Baseline|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
11051766|NCT01313078|FG000|Participant Flow|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
11051767|NCT01313078|OG000|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
11051768|NCT01313078|EG000|Reported Event|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
11051769|NCT01313117|BG000|Baseline|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
11051770|NCT01313117|FG000|Participant Flow|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
11051771|NCT01313117|OG000|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
11051772|NCT01313117|OG000|Outcome|Alpha Lipoic Acid|The study was designed to first explore the optimal ALA dose. The baseline dose was 100 mg three times daily for four months. Dose escalation was to occur until a maximum tolerated dose (MTD) was found. Once the MTD was established we were then to enroll additional patients at the MTD for efficacy analysis. The study failed to reach the MTD. Only small numbers of patients were enrolled. As such, we were unable to perform any meaningful efficacy (TNS) analysis.
11051773|NCT01313117|EG000|Reported Event|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
11051774|NCT01313182|BG000|Baseline|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
11051775|NCT01313182|BG001|Baseline|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
11051776|NCT01313182|BG002|Baseline|Total|Total of all reporting groups
11051777|NCT01313182|FG000|Participant Flow|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
11051778|NCT01313182|FG001|Participant Flow|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
11051779|NCT01313182|OG000|Outcome|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
11051780|NCT01313182|OG001|Outcome|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
11051781|NCT01313182|EG000|Reported Event|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
11051782|NCT01313182|EG001|Reported Event|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
11051783|NCT01313208|BG000|Baseline|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
11051784|NCT01313208|BG001|Baseline|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.~All participants continued their DMARD treatment throughout the 24-week study period."
11051785|NCT01313208|BG002|Baseline|Total|Total of all reporting groups
11051786|NCT01313208|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
11051787|NCT01313208|FG001|Participant Flow|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.~All participants continued their DMARD treatment throughout the 24-week study period."
11051788|NCT01313208|OG000|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
11051789|NCT01313208|OG001|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
11051790|NCT01313208|OG000|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
11051791|NCT01313208|OG001|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
11051792|NCT01313208|EG000|Reported Event|Placebo-Etanercept|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
11051793|NCT01313208|EG001|Reported Event|Etanercept-Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
11051794|NCT01313221|BG000|Baseline|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
11051795|NCT01313221|BG001|Baseline|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
11051796|NCT01313221|BG002|Baseline|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
11051797|NCT01313221|BG003|Baseline|Total|Total of all reporting groups
11051798|NCT01313221|FG000|Participant Flow|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
11051799|NCT01313221|FG001|Participant Flow|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
11051800|NCT01313221|FG002|Participant Flow|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
11051801|NCT01313221|OG000|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
11051802|NCT01313221|OG001|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
11051803|NCT01313221|OG000|Outcome|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
11051804|NCT01313221|OG001|Outcome|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
11051805|NCT01313221|EG000|Reported Event|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
11051806|NCT01313221|EG001|Reported Event|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
11051807|NCT01313286|BG000|Baseline|All Participants|A single oral dose of 80 mg LY2608204 reference formulation in Period 1 and a single oral dose of 80 mg LY2608204 test formulation in Period 2; or a single oral dose of 80 mg test formulation in Period 1 and a single oral dose of 80 mg reference formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
11051808|NCT01313286|FG000|Participant Flow|LY2608204 Reference, LY2608204 Test|A single oral dose of 80 mg LY2608204 reference formulation in Period 1 and a single oral dose of 80 mg LY2608204 test formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
11051809|NCT01313286|FG001|Participant Flow|LY2608204 Test, LY2608204 Reference|A single oral dose of 80 mg LY2608204 test formulation in Period 1 and a single oral dose of 80 mg LY2608204 reference formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
11051810|NCT01313286|OG000|Outcome|LY2608204 Free Base (Reference Formulation)|a single oral dose of 80 mg LY2608204 reference formulation (free base)
11051811|NCT01313286|OG001|Outcome|LY2608204 Hydrochloride (HCl) Salt (Test Formulation)|a single oral dose of 80 mg LY2608204 test formulation (HCl salt)
11051812|NCT01313286|EG000|Reported Event|LY2608204 Reference Formulation|A single oral dose of 80 mg LY2608204 reference formulation.
11051813|NCT01313286|EG001|Reported Event|LY2608204 Test Formulation|A single oral dose of 80 mg LY2608204 test formulation.
11051814|NCT01313299|BG000|Baseline|Placebo|Placebo intramuscular injection single treatment cycle on day 1
11051815|NCT01313299|BG001|Baseline|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
11051816|NCT01313299|BG002|Baseline|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
11051817|NCT01313299|BG003|Baseline|Total|Total of all reporting groups
11051818|NCT01313299|FG000|Participant Flow|Placebo|Placebo intramuscular injection single treatment cycle on day 1
11051819|NCT01313299|FG001|Participant Flow|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
11051820|NCT01313299|FG002|Participant Flow|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
11051821|NCT01313299|OG000|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
11051822|NCT01313299|OG001|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
11051823|NCT01313299|OG002|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
11051824|NCT01313299|EG000|Reported Event|Placebo|Placebo intramuscular injection single treatment cycle on day 1
11051825|NCT01313299|EG001|Reported Event|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
11051826|NCT01313299|EG002|Reported Event|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
11051827|NCT01313312|BG000|Baseline|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
11051828|NCT01313312|FG000|Participant Flow|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 intramuscular (i.m.) injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
11051829|NCT01313312|OG000|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
11051830|NCT01313312|EG000|Reported Event|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
11051831|NCT01313494|BG000|Baseline|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
11051832|NCT01313494|BG001|Baseline|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
11051833|NCT01313494|BG002|Baseline|Total|Total of all reporting groups
11051834|NCT01313494|FG000|Participant Flow|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
11051835|NCT01313494|FG001|Participant Flow|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
11051836|NCT01313494|OG000|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
11051837|NCT01313494|OG001|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
11051838|NCT01313494|EG000|Reported Event|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
11051839|NCT01313494|EG001|Reported Event|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
11051840|NCT01313507|BG000|Baseline|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
11051841|NCT01313507|FG000|Participant Flow|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
11051842|NCT01313507|OG000|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
11051843|NCT01313507|EG000|Reported Event|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
11051844|NCT01313520|BG000|Baseline|Infliximab|3 mg/kg of Infliximab intravenous infusion
11051845|NCT01313520|BG001|Baseline|Placebo|saline via intravenous infusion
11051846|NCT01313520|BG002|Baseline|Total|Total of all reporting groups
11051847|NCT01313520|FG000|Participant Flow|Infliximab|3 mg/kg of Infliximab intravenous infusion
11051848|NCT01313520|FG001|Participant Flow|Placebo|saline via intravenous infusion
11051849|NCT01313520|OG000|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
11051850|NCT01313520|OG001|Outcome|Placebo|saline via intravenous infusion
11051851|NCT01313520|OG000|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
11051852|NCT01313520|OG001|Outcome|Placebo|Saline via intravenous infusion
11051853|NCT01313520|EG000|Reported Event|Infliximab|3 mg/kg of Infliximab intravenous infusion
10847005|NCT00281580|FG010|Participant Flow|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
11051854|NCT01313520|EG001|Reported Event|Placebo|saline via intravenous infusion
11051855|NCT01313559|BG000|Baseline|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
11051856|NCT01313559|BG001|Baseline|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
11051857|NCT01313559|BG002|Baseline|Total|Total of all reporting groups
11051858|NCT01313559|FG000|Participant Flow|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
11051859|NCT01313559|FG001|Participant Flow|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
11051860|NCT01313559|OG000|Outcome|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
11051861|NCT01313559|OG001|Outcome|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
11051862|NCT01313559|EG000|Reported Event|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
11051863|NCT01313559|EG001|Reported Event|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
11051864|NCT01313624|BG000|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051865|NCT01313624|BG001|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051866|NCT01313624|BG002|Baseline|Total|Total of all reporting groups
11051867|NCT01313624|FG000|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051868|NCT01313624|FG001|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051869|NCT01313624|OG000|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051870|NCT01313624|OG001|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051871|NCT01313624|EG000|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051872|NCT01313624|EG001|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051873|NCT01313624|EG002|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051874|NCT01313624|EG003|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11051875|NCT01313637|BG000|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
11051876|NCT01313637|BG001|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
11051877|NCT01313637|BG002|Baseline|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
11051878|NCT01313637|BG003|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
11051879|NCT01313637|BG004|Baseline|Total|Total of all reporting groups
11051880|NCT01313637|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
11051881|NCT01313637|FG001|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD via a DPI in the morning for 24 weeks.
11051882|NCT01313637|FG002|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
11051883|NCT01313637|FG003|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
11051884|NCT01313637|OG000|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
11051885|NCT01313637|OG001|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
11051886|NCT01313637|OG002|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
11051887|NCT01313637|OG003|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
11051888|NCT01313637|EG000|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
11051889|NCT01313637|EG001|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
11051890|NCT01313637|EG002|Reported Event|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
11051891|NCT01313637|EG003|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
11051892|NCT01313650|BG000|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
11051893|NCT01313650|BG001|Baseline|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
11051894|NCT01313650|BG002|Baseline|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
11051895|NCT01313650|BG003|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
11051896|NCT01313650|BG004|Baseline|Total|Total of all reporting groups
11051897|NCT01313650|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
11051898|NCT01313650|FG001|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 24 weeks.
11051899|NCT01313650|FG002|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
11051900|NCT01313650|FG003|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
11051901|NCT01313650|OG000|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
11051902|NCT01313650|OG001|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
11051903|NCT01313650|OG002|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
11051904|NCT01313650|OG003|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
11051905|NCT01313650|EG000|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
11051906|NCT01313650|EG001|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
11051907|NCT01313650|EG002|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
11051908|NCT01313650|EG003|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
11051909|NCT01313663|BG000|Baseline|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
11051910|NCT01313663|BG001|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
11051911|NCT01313663|BG002|Baseline|Total|Total of all reporting groups
11051912|NCT01313663|FG000|Participant Flow|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
11051913|NCT01313663|FG001|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
11051914|NCT01313663|OG000|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
11051915|NCT01313663|OG001|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
11051916|NCT01313663|EG000|Reported Event|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
11051917|NCT01313663|EG001|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
11066762|NCT01393964|BG000|Baseline|Elotuzumab + LD in Normal Renal Function (NRF) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
11066763|NCT01393964|BG001|Baseline|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
11066764|NCT01393964|BG002|Baseline|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
11066765|NCT01393964|BG003|Baseline|Total|Total of all reporting groups
11066766|NCT01393964|FG000|Participant Flow|Elotuzumab + LD in Normal Renal Function(NRF) Participants|Combination of lenalidomide and dexamethasone (LD). Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle (per product label). Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF = CrCl ≥ 90 milliliters per minute (mL/min).
11066767|NCT01393964|FG001|Participant Flow|Elotuzumab + LD in Severe Renal Impairment(SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI = estimated CrCl < 30 ml/min but no dialysis.
11066768|NCT01393964|FG002|Participant Flow|Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD = requires hemodialysis.
11066769|NCT01393964|OG000|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
11066770|NCT01393964|OG001|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
11051918|NCT01313676|BG000|Baseline|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051919|NCT01313676|BG001|Baseline|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051920|NCT01313676|BG002|Baseline|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051921|NCT01313676|BG003|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051922|NCT01313676|BG004|Baseline|Total|Total of all reporting groups
11051923|NCT01313676|FG000|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051924|NCT01313676|FG001|Participant Flow|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051925|NCT01313676|FG002|Participant Flow|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051926|NCT01313676|FG003|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051927|NCT01313676|OG000|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051928|NCT01313676|OG001|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051929|NCT01313676|OG002|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051930|NCT01313676|OG003|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051931|NCT01313676|OG000|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period
11051932|NCT01313676|EG000|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051933|NCT01313676|EG001|Reported Event|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051934|NCT01313676|EG002|Reported Event|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051935|NCT01313676|EG003|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
11051936|NCT01313728|BG000|Baseline|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
11051937|NCT01313728|FG000|Participant Flow|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
11051938|NCT01313728|OG000|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
11051939|NCT01313728|OG001|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
11051940|NCT01313728|EG000|Reported Event|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
11051941|NCT01313767|BG000|Baseline|Meditoxin®|Botulinum toxin type A
11051942|NCT01313767|BG001|Baseline|Botox®|Botulinum Toxin type A
11051943|NCT01313767|BG002|Baseline|Total|Total of all reporting groups
11051944|NCT01313767|FG000|Participant Flow|Meditoxin®|Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle
11051945|NCT01313767|FG001|Participant Flow|Botox®|Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle
11051946|NCT01313767|OG000|Outcome|Meditoxin®|Botulinum toxin type A
11051947|NCT01313767|OG001|Outcome|Botox®|Botulinum Toxin type A
11051948|NCT01313767|EG000|Reported Event|Meditoxin®|Botulinum toxin type A
11051949|NCT01313767|EG001|Reported Event|Botox®|Botulinum Toxin type A
11051950|NCT01313780|BG000|Baseline|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
11051951|NCT01313780|BG001|Baseline|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
11051952|NCT01313780|BG002|Baseline|Total|Total of all reporting groups
11051953|NCT01313780|FG000|Participant Flow|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
11051954|NCT01313780|FG001|Participant Flow|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
11051955|NCT01313780|OG000|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
11051956|NCT01313780|OG001|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
11051957|NCT01313780|EG000|Reported Event|Oxycodone and Naloxone|Oxycodone and naloxone: Trade name is TARGIN.
11051958|NCT01313780|EG001|Reported Event|Oxycodone|oxycodone : Trade name is Oxycontin
11051959|NCT01313858|BG000|Baseline|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
11051960|NCT01313858|BG001|Baseline|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
11051961|NCT01313858|BG002|Baseline|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
11051962|NCT01313858|BG003|Baseline|Total|Total of all reporting groups
11051963|NCT01313858|FG000|Participant Flow|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
11051964|NCT01313858|FG001|Participant Flow|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
11051965|NCT01313858|FG002|Participant Flow|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
11051966|NCT01313858|OG000|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
11051967|NCT01313858|OG001|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
11051968|NCT01313858|OG002|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
11051969|NCT01313858|EG000|Reported Event|All Participants|Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
11051970|NCT01313884|BG000|Baseline|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
11051971|NCT01313884|FG000|Participant Flow|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
11051972|NCT01313884|OG000|Outcome|Combination Therapy|"Regimen A alternating with Regimen B every 21 days~Regimen A:~Cytoxan 1200mg/m2~Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2~Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg~Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle~Regimen B:~Irinotecan 50 mg/m2/day x 5 days~Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free"
11051973|NCT01313884|EG000|Reported Event|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
11051974|NCT01313897|BG000|Baseline|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
11051975|NCT01313897|FG000|Participant Flow|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
11051976|NCT01313897|OG000|Outcome|Velcade for Anti-MM Therapy|"Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v.~Bortezomib: bortezomib given days -9, -6, and -2 at 1.0mg/m2, i.v."
11051977|NCT01313897|EG000|Reported Event|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
11051978|NCT01313910|BG000|Baseline|ImmunoLin®|8-week treatment course
11051979|NCT01313910|FG000|Participant Flow|ImmunoLin®|2.5 grams twice daily for eight weeks
11051980|NCT01313910|OG000|Outcome|ImmunoLin®|8-week treatment course
11051981|NCT01313910|EG000|Reported Event|ImmunoLin®|8-week treatment course
11051982|NCT01313936|BG000|Baseline|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
11051983|NCT01313936|BG001|Baseline|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
11051984|NCT01313936|BG002|Baseline|Total|Total of all reporting groups
11051985|NCT01313936|FG000|Participant Flow|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
11051986|NCT01313936|FG001|Participant Flow|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
11051987|NCT01313936|OG000|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
11051988|NCT01313936|OG001|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
11051989|NCT01313936|OG000|Outcome|Homozygous Wildtype|Wildtype population, no UGT1A1 polymorphisms
11051990|NCT01313936|OG001|Outcome|Heterozygous UGT1A1*28 Genotype|Population Heterozygous for UGT1A1*28 polymorphisms
11051991|NCT01313936|OG002|Outcome|Homozygous UGT1A1*28 Genotype|Population homozygous UGT1A1*28 genotype polymorphisms
11051992|NCT01313936|EG000|Reported Event|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
11051993|NCT01313936|EG001|Reported Event|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
11051994|NCT01314001|BG000|Baseline|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
11051995|NCT01314001|BG001|Baseline|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
11051996|NCT01314001|BG002|Baseline|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
11051997|NCT01314001|BG003|Baseline|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
11051998|NCT01314001|BG004|Baseline|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
11051999|NCT01314001|BG005|Baseline|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
11052000|NCT01314001|BG006|Baseline|Total|Total of all reporting groups
11052001|NCT01314001|FG000|Participant Flow|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
11052002|NCT01314001|FG001|Participant Flow|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
11052003|NCT01314001|FG002|Participant Flow|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
11052004|NCT01314001|FG003|Participant Flow|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
11052005|NCT01314001|FG004|Participant Flow|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
11052006|NCT01314001|FG005|Participant Flow|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
11052007|NCT01314001|OG000|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
11052008|NCT01314001|OG001|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
11052009|NCT01314001|OG002|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
11052010|NCT01314001|OG003|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
11052011|NCT01314001|OG004|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
11052012|NCT01314001|OG005|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
11052013|NCT01314001|EG000|Reported Event|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
11052014|NCT01314001|EG001|Reported Event|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
11052015|NCT01314001|EG002|Reported Event|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
11052016|NCT01314001|EG003|Reported Event|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
11052017|NCT01314001|EG004|Reported Event|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
11052018|NCT01314001|EG005|Reported Event|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
11052019|NCT01314014|BG000|Baseline|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
11052020|NCT01314014|FG000|Participant Flow|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
11052021|NCT01314014|OG000|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
11052022|NCT01314014|EG000|Reported Event|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
11052023|NCT01314105|BG000|Baseline|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052024|NCT01314105|BG001|Baseline|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052025|NCT01314105|BG002|Baseline|Total|Total of all reporting groups
11052026|NCT01314105|FG000|Participant Flow|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052027|NCT01314105|FG001|Participant Flow|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052028|NCT01314105|OG000|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052029|NCT01314105|OG001|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052030|NCT01314105|OG000|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052031|NCT01314105|OG001|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052032|NCT01314105|EG000|Reported Event|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052033|NCT01314105|EG001|Reported Event|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
11052034|NCT01314261|BG000|Baseline|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052035|NCT01314261|BG001|Baseline|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052036|NCT01314261|BG002|Baseline|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052037|NCT01314261|BG003|Baseline|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052038|NCT01314261|BG004|Baseline|Total|Total of all reporting groups
11052039|NCT01314261|FG000|Participant Flow|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052040|NCT01314261|FG001|Participant Flow|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052041|NCT01314261|FG002|Participant Flow|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052042|NCT01314261|FG003|Participant Flow|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052043|NCT01314261|OG000|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052044|NCT01314261|OG001|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052045|NCT01314261|OG002|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052046|NCT01314261|OG003|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052047|NCT01314261|EG000|Reported Event|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052048|NCT01314261|EG001|Reported Event|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 10 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052049|NCT01314261|EG002|Reported Event|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052050|NCT01314261|EG003|Reported Event|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
11052051|NCT01314313|BG000|Baseline|PIIA: SAPIEN XT|Edwards SAPIEN XT Transcatheter Heart Valve (THV)
11052052|NCT01314313|BG001|Baseline|Control: SAVR|Surgical Aortic Valve Replacement (SAVR); Control for PIIA: SAPIEN XT
11052053|NCT01314313|BG002|Baseline|Total|Total of all reporting groups
11052054|NCT01314313|FG000|Participant Flow|PIIA: SAPIEN XT|"Edwards SAPIEN XT Transcatheter Heart Valve (THV)~NOTE: SAVR with surgical bioprosthetic heart valve is the control arm."
11052055|NCT01314313|FG001|Participant Flow|Control: SAVR|Surgical Aortic Valve Replacement (SAVR)
11052056|NCT01314313|OG000|Outcome|PIIA: SAPIEN XT|Edwards SAPIEN XT Transcatheter Heart Valve (THV)
11052057|NCT01314313|OG001|Outcome|Control: SAVR|Control: Surgical Aortic Valve Replacement (SAVR)
11052058|NCT01314313|OG000|Outcome|PIIA: SAPIEN XT|Intermediate Risk Surgical Patients: Transcatheter Heart Valve (THV)
11052059|NCT01314313|OG001|Outcome|Control: SAVR|Surgical Aortic Valve Replacement (SAVR)
11052060|NCT01314313|EG000|Reported Event|PIIA: SAPIEN XT - 2 Year|Edwards SAPIEN XT Transcatheter Heart Valve (THV)
11052061|NCT01314313|EG001|Reported Event|Control: SAVR - 2 Year|"Surgical Aortic Valve Replacement (SAVR)~NOTE: SAVR with surgical bioprosthetic heart valve is the control arm."
11052062|NCT01314417|BG000|Baseline|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
11052063|NCT01314417|FG000|Participant Flow|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
11052064|NCT01314417|OG000|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
11052065|NCT01314417|EG000|Reported Event|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
11052066|NCT01314443|BG000|Baseline|Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
11052067|NCT01314443|BG001|Baseline|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
11052068|NCT01314443|BG002|Baseline|Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of NRT
11052069|NCT01314443|BG003|Baseline|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of NRT
11052070|NCT01314443|BG004|Baseline|Total|Total of all reporting groups
11052071|NCT01314443|FG000|Participant Flow|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
11052072|NCT01314443|FG001|Participant Flow|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
11052073|NCT01314443|FG002|Participant Flow|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
11052074|NCT01314443|FG003|Participant Flow|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
11052075|NCT01314443|OG000|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
11052076|NCT01314443|OG001|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
11052077|NCT01314443|OG002|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
11052078|NCT01314443|OG003|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
11052079|NCT01314443|EG000|Reported Event|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
11052080|NCT01314443|EG001|Reported Event|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
11052081|NCT01314443|EG002|Reported Event|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
11052082|NCT01314443|EG003|Reported Event|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
11052083|NCT01314703|BG000|Baseline|Group 1|All subjects received treatment with both the test article and the positive control
11052084|NCT01314703|FG000|Participant Flow|ChloraPrep and 70% Isopropyl Alcohol|All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol
11052085|NCT01314703|OG000|Outcome|ChloraPrep One Step, 10.5 mL Applicator|All subjects received single application of treatment with ChloraPrep One Step 10.5 mL Applicator on two treatment sites (abdomen and groin).
11052086|NCT01314703|OG001|Outcome|70% Isopropyl Alcohol, 10.5 mL Applicator|All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin).
11052087|NCT01314703|EG000|Reported Event|Group 1|All subjects received treatment with both the test article and the positive control
11052088|NCT01314716|BG000|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11052089|NCT01314716|BG001|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11052090|NCT01314716|BG002|Baseline|Total|Total of all reporting groups
11052091|NCT01314716|FG000|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
11052092|NCT01314716|FG001|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
11052093|NCT01314716|OG000|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11052094|NCT01314716|OG001|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11052095|NCT01314716|EG000|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11052096|NCT01314716|EG001|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11052097|NCT01314716|EG002|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11052098|NCT01314716|EG003|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
11052099|NCT01314742|BG000|Baseline|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
11052100|NCT01314742|BG001|Baseline|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
11052101|NCT01314742|BG002|Baseline|Total|Total of all reporting groups
11052102|NCT01314742|FG000|Participant Flow|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
11052103|NCT01314742|FG001|Participant Flow|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
11052104|NCT01314742|OG000|Outcome|Biotene OralBalance® Gel Arm|Study group receiving timed oral care with Biotene OralBalance® gel Arm
11052105|NCT01314742|OG001|Outcome|Sterile Water Group|Study group receiving timed oral care with Sterile Water
11052106|NCT01314742|OG000|Outcome|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
11052107|NCT01314742|OG001|Outcome|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
11052108|NCT01314742|EG000|Reported Event|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
11052109|NCT01314742|EG001|Reported Event|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
11052110|NCT01314872|BG000|Baseline|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
10847006|NCT00281580|FG011|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
11052111|NCT01314872|BG001|Baseline|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052112|NCT01314872|BG002|Baseline|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052113|NCT01314872|BG003|Baseline|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052114|NCT01314872|BG004|Baseline|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052115|NCT01314872|BG005|Baseline|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
11052116|NCT01314872|BG006|Baseline|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
11052117|NCT01314872|BG007|Baseline|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
11052118|NCT01314872|BG008|Baseline|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
10847007|NCT00281580|FG012|Participant Flow|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
11052119|NCT01314872|BG009|Baseline|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
11052120|NCT01314872|BG010|Baseline|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
11052121|NCT01314872|BG011|Baseline|Total|Total of all reporting groups
11052122|NCT01314872|FG000|Participant Flow|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
11052123|NCT01314872|FG001|Participant Flow|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052124|NCT01314872|FG002|Participant Flow|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052125|NCT01314872|FG003|Participant Flow|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052126|NCT01314872|FG004|Participant Flow|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052127|NCT01314872|FG005|Participant Flow|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
11149203|NCT01869439|BG000|Baseline|External Wounds Measured for Length by Width Using a Ruler|"This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.~gold standard LxW manual ruler measurement technique: The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).~LxW measurement technique: This software measurement technique measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).~Visual External Wound Trace: This software measurement enables the user to trace the perimeter edge of the wound's visual image.~External Wound Trace Overlay: This software measurement utilizes the visual external wound trace and overlaying it onto the thermal wound site. From the thermal overlay, data such as the differences in the thermal intensities (gradiency), mean, and the mode of the thermal wound bed can be measured."
11149204|NCT01869439|FG000|Participant Flow|Wounds Measures of LxW Ruler & Software LxW, Area & Perimeter|"This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.~gold standard LxW manual ruler measurement technique: Currently, the gold standard LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).~WMMS ImageReview software's LxW measurement technique: This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).~WMMS ImageReview software's Visual External Wound Trace: This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image."
11149205|NCT01869439|OG000|Outcome|Wounds Measured for Length by Width Using a Ruler and Software|"This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.~The gold standard LxW manual ruler measurement technique: Currently, the gold standard LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).~Software LxW measurement technique: This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).~Software's Visual External Wound Trace: This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image."
11149206|NCT01869439|EG000|Reported Event|External Wounds Measured for Length by Width Using a Ruler|"This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.~gold standard LxW manual ruler measurement technique: Currently, the gold standard LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).~WMMS ImageReview software's LxW measurement technique: This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).~WMMS ImageReview software's Visual External Wound Trace: This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image."
11149207|NCT01869634|BG000|Baseline|HIV Positive Naive to ART|"HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.~darunavir with ritonavir and fixed-dose viread+emtricitabine daily"
11149208|NCT01869634|BG001|Baseline|Normal Control Volunteers|HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
11149209|NCT01869634|BG002|Baseline|Total|Total of all reporting groups
11149210|NCT01869634|FG000|Participant Flow|HIV Positive Naive to ART|"HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.~darunavir with ritonavir and fixed-dose viread+emtricitabine daily"
11149211|NCT01869634|FG001|Participant Flow|Normal Control Volunteers|HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
11149212|NCT01869634|OG000|Outcome|HIV Positive Naive to ART|"HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.~darunavir with ritonavir and fixed-dose viread+emtricitabine daily"
11149213|NCT01869634|OG001|Outcome|Normal Control Volunteers|HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
11149214|NCT01869634|EG000|Reported Event|HIV Positive Naive to ART|"HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.~darunavir with ritonavir and fixed-dose viread+emtricitabine daily"
10847008|NCT00281580|FG013|Participant Flow|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
11052128|NCT01314872|FG006|Participant Flow|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
11052129|NCT01314872|FG007|Participant Flow|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
11052130|NCT01314872|FG008|Participant Flow|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
11052131|NCT01314872|FG009|Participant Flow|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
11052132|NCT01314872|FG010|Participant Flow|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
11052133|NCT01314872|FG011|Participant Flow|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
11052134|NCT01314872|FG012|Participant Flow|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
11052135|NCT01314872|FG013|Participant Flow|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
11052136|NCT01314872|FG014|Participant Flow|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
11052137|NCT01314872|OG000|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
11052138|NCT01314872|OG001|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052139|NCT01314872|OG002|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052140|NCT01314872|OG003|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052141|NCT01314872|OG004|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052142|NCT01314872|OG005|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
11052143|NCT01314872|OG006|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
11052144|NCT01314872|OG007|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
11052145|NCT01314872|OG008|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
11052146|NCT01314872|OG009|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
11052147|NCT01314872|OG010|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
11149215|NCT01869634|EG001|Reported Event|Normal Control Volunteers|HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
11052148|NCT01314872|OG000|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
11052149|NCT01314872|OG001|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
11052150|NCT01314872|OG002|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
11052151|NCT01314872|OG003|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
11052152|NCT01314872|EG000|Reported Event|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
11052153|NCT01314872|EG001|Reported Event|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052154|NCT01314872|EG002|Reported Event|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052155|NCT01314872|EG003|Reported Event|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052156|NCT01314872|EG004|Reported Event|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
11052157|NCT01314872|EG005|Reported Event|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
11052158|NCT01314872|EG006|Reported Event|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
11052159|NCT01314872|EG007|Reported Event|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
11052160|NCT01314872|EG008|Reported Event|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
11052161|NCT01314872|EG009|Reported Event|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
11052162|NCT01314872|EG010|Reported Event|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
11052163|NCT01314872|EG011|Reported Event|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
11052164|NCT01314872|EG012|Reported Event|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
11052165|NCT01314872|EG013|Reported Event|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
11052166|NCT01314872|EG014|Reported Event|Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
11052167|NCT01314911|BG000|Baseline|Oseltamivir|Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
10847009|NCT00281580|FG014|Participant Flow|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
11052168|NCT01314911|BG001|Baseline|Placebo|Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
11052169|NCT01314911|BG002|Baseline|Total|Total of all reporting groups
11052170|NCT01314911|FG000|Participant Flow|Oseltamivir|Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
11052171|NCT01314911|FG001|Participant Flow|Placebo|Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
11052172|NCT01314911|OG000|Outcome|Oseltamivir|Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
11052173|NCT01314911|OG001|Outcome|Placebo|Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
11052174|NCT01314911|EG000|Reported Event|Oseltamivir|Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
11052175|NCT01314911|EG001|Reported Event|Placebo|Placebo: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
11052176|NCT01314963|BG000|Baseline|All Participants|This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants.
11052177|NCT01314963|FG000|Participant Flow|All Participants|This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants.
11052178|NCT01314963|OG000|Outcome|Intraoperative Handheld Gamma Camera (pIHGC)|"The prototype intraoperative handheld gamma camera (pIHGC)~radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site."
11052179|NCT01314963|OG001|Outcome|Gamma Probes (GP)|"Lymphoscintigraphy with standard of care intraoperative gamma probes (GP)~radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site."
11052180|NCT01314963|EG000|Reported Event|All Participants - Intraoperative Handheld Gamma Camera (pIHGC|The entire set of sentinel lymph nodes (SLNs) excised from study participants (ie, all participants) were evaluated with the intraoperative handheld gamma camera (pIHGC).
11052181|NCT01314963|EG001|Reported Event|All Participants - Gamma Probes (GP)|The entire set of sentinel lymph nodes (SLNs) excised from study participants (ie, all participants) were evaluated with the gamma probes (GP).
11052182|NCT01315002|BG000|Baseline|All Study Participants|Includes groups randomized to receive nicotine first and placebo first. Number of all study participants = 121.
11052183|NCT01315002|FG000|Participant Flow|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
11052184|NCT01315002|FG001|Participant Flow|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
11052185|NCT01315002|OG000|Outcome|Nicotine Patch|"Transdermal nicotine patch~Transdermal nicotine patch: 7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)"
11052186|NCT01315002|OG001|Outcome|Placebo Patch|"Placebo patch~Placebo patch: Placebo patch"
11052187|NCT01315002|EG000|Reported Event|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
11052188|NCT01315002|EG001|Reported Event|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
11052189|NCT01315028|BG000|Baseline|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
11052190|NCT01315028|BG001|Baseline|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
11052191|NCT01315028|BG002|Baseline|Total|Total of all reporting groups
11052192|NCT01315028|FG000|Participant Flow|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
11052193|NCT01315028|FG001|Participant Flow|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
11052194|NCT01315028|OG000|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
11052195|NCT01315028|OG001|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
11052196|NCT01315028|EG000|Reported Event|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
11052197|NCT01315028|EG001|Reported Event|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
11052198|NCT01315132|BG000|Baseline|Allogeneic Transplantation|"Matched Sibling Allogeneic Transplantation~Matched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization"
11052199|NCT01315132|FG000|Participant Flow|Allogeneic Transplantation|"Matched Sibling Allogeneic Transplantation~Matched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization"
11052200|NCT01315132|OG000|Outcome|Allogeneic Transplantation|"Matched Sibling Allogeneic Transplantation~Matched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization"
11052201|NCT01315132|EG000|Reported Event|Allogeneic Transplantation|"Matched Sibling Allogeneic Transplantation~Matched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization"
11052202|NCT01315145|BG000|Baseline|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
11052203|NCT01315145|BG001|Baseline|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
11052204|NCT01315145|BG002|Baseline|Total|Total of all reporting groups
11052205|NCT01315145|FG000|Participant Flow|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
11052206|NCT01315145|FG001|Participant Flow|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
11052207|NCT01315145|OG000|Outcome|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
11052208|NCT01315145|OG001|Outcome|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
11052209|NCT01315145|EG000|Reported Event|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
11052210|NCT01315145|EG001|Reported Event|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
11349015|NCT04131517|BG001|Baseline|Part 1 Sequence B|Participants received a single dose of OC tablet on Day 1 during first Treatment Period. Participants received padsevonil tablets 100 mg up-titrated to 400 mg, bid on Day 18 to 23 followed by padsevonil 400 mg bid on Day 24 to 31 along with a single dose of OC tablet on Day 30 and, then padsevonil down-titrated from 400 mg to 100 mg bid from Day 32 to 36 during second Treatment Period. There was a Washout Period of 14 days between the two Treatment Periods.
11052211|NCT01315158|BG000|Baseline|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
11052212|NCT01315158|BG001|Baseline|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
11052213|NCT01315158|BG002|Baseline|Total|Total of all reporting groups
11052214|NCT01315158|FG000|Participant Flow|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
11052215|NCT01315158|FG001|Participant Flow|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
11052216|NCT01315158|OG000|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
11052217|NCT01315158|OG001|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
11052218|NCT01315158|EG000|Reported Event|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
11052219|NCT01315158|EG001|Reported Event|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
11052220|NCT01315236|BG000|Baseline|LAI 590 mg QD|"LAI 590 mg QD~Liposomal amikacin for inhalation (LAI): - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered for 84 days in the double-blind, randomized portion of the study.~Subjects can continue with 84 additional days of dosing in the open label extension."
11052221|NCT01315236|BG001|Baseline|Placebo|"placebo QD~placebo: - Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.~Administration procedures, volume and administration time are similar to LAI.~Placebo will be administered for 84 days only during the double-blind, randomized portion of the study."
11052222|NCT01315236|BG002|Baseline|Total|Total of all reporting groups
11052223|NCT01315236|FG000|Participant Flow|LAI 590 mg QD|"LAI 590 mg QD~Liposomal amikacin for inhalation (LAI): - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered for 84 days in the double-blind, randomized portion of the study.~Subjects can continue with 84 additional days of dosing in the open label extension."
11052224|NCT01315236|FG001|Participant Flow|Placebo|"placebo QD~placebo: - Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.~Administration procedures, volume and administration time are similar to LAI.~Placebo will be administered for 84 days only during the double-blind, randomized portion of the study."
11052225|NCT01315236|OG000|Outcome|LAI 590 mg QD|"LAI 590 mg QD~Liposomal amikacin for inhalation (LAI): - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered for 84 days in the double-blind, randomized portion of the study.~Subjects can continue with 84 additional days of dosing in the open label extension."
11349016|NCT04131517|BG002|Baseline|Total Title|
11052226|NCT01315236|OG001|Outcome|Placebo|"placebo QD~placebo: - Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.~Administration procedures, volume and administration time are similar to LAI.~Placebo will be administered for 84 days only during the double-blind, randomized portion of the study."
11052227|NCT01315236|EG000|Reported Event|LAI 590 mg QD - Double Blind|"LAI 590 mg QD~Liposomal amikacin for inhalation (LAI): - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered for 84 days in the double-blind, randomized portion of the study.~Subjects can continue with 84 additional days of dosing in the open label extension."
11052228|NCT01315236|EG001|Reported Event|Placebo - Double Blind|"placebo QD~placebo: - Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.~Administration procedures, volume and administration time are similar to LAI.~Placebo will be administered for 84 days only during the double-blind, randomized portion of the study."
11052229|NCT01315236|EG002|Reported Event|LAI 590 mg QD - Open Label|"LAI 590 mg QD~Liposomal amikacin for inhalation (LAI): - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~- 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Subjects can continue with 84 additional days of dosing in the open label extension."
11052230|NCT01315236|EG003|Reported Event|Placebo - Open Label|"placebo QD~placebo: - Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.~Subjects can continue with 84 additional days of dosing in the open label extension."
11052231|NCT01315249|BG000|Baseline|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
11052232|NCT01315249|BG001|Baseline|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
11052233|NCT01315249|BG002|Baseline|Total|Total of all reporting groups
11052234|NCT01315249|FG000|Participant Flow|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
11052235|NCT01315249|FG001|Participant Flow|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
11052236|NCT01315249|OG000|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
11052237|NCT01315249|OG001|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
11052238|NCT01315249|EG000|Reported Event|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
11052239|NCT01315249|EG001|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
11052240|NCT01315574|BG000|Baseline|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
11052241|NCT01315574|BG001|Baseline|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
11052242|NCT01315574|BG002|Baseline|Total|Total of all reporting groups
11052243|NCT01315574|FG000|Participant Flow|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
11052244|NCT01315574|FG001|Participant Flow|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
11052245|NCT01315574|OG000|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
11052246|NCT01315574|OG001|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
11052247|NCT01315574|EG000|Reported Event|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
11052248|NCT01315574|EG001|Reported Event|Travoprost (Travatan Z)|"7 Patients were be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
11052249|NCT01315665|BG000|Baseline|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052250|NCT01315665|BG001|Baseline|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052251|NCT01315665|BG002|Baseline|Total|Total of all reporting groups
11052252|NCT01315665|FG000|Participant Flow|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052253|NCT01315665|FG001|Participant Flow|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052254|NCT01315665|OG000|Outcome|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052255|NCT01315665|OG001|Outcome|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052256|NCT01315665|OG000|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052257|NCT01315665|OG001|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052258|NCT01315665|EG000|Reported Event|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052259|NCT01315665|EG001|Reported Event|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
11052260|NCT01315678|BG000|Baseline|Arikayce™|"Arikayce™ is liposomal amikacin for inhalation~Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer: Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11052261|NCT01315678|BG001|Baseline|TOBI®|"TOBI® is tobramycin inhalation solution~Tobramycin inhalation solution using a PARI LC® Plus nebulizer: 300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer.~Nebulization time is approximately 20 minutes for each administration.~Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment"
11052262|NCT01315678|BG002|Baseline|Total|Total of all reporting groups
11052263|NCT01315678|FG000|Participant Flow|Arikayce™|"Arikayce™ is liposomal amikacin for inhalation~Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer: Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11052264|NCT01315678|FG001|Participant Flow|TOBI®|"TOBI® is tobramycin inhalation solution~Tobramycin inhalation solution using a PARI LC® Plus nebulizer: 300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer.~Nebulization time is approximately 20 minutes for each administration.~Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment"
11052265|NCT01315678|OG000|Outcome|Arikayce™|"Arikayce™ is liposomal amikacin for inhalation~Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer: Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11052266|NCT01315678|OG001|Outcome|TOBI®|"TOBI® is tobramycin inhalation solution~Tobramycin inhalation solution using a PARI LC® Plus nebulizer: 300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer.~Nebulization time is approximately 20 minutes for each administration.~Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment"
11052267|NCT01315678|OG000|Outcome|Arikayce™|
11052268|NCT01315678|OG001|Outcome|TOBI®|
11052269|NCT01315678|EG000|Reported Event|Arikayce™|"Arikayce™ is liposomal amikacin for inhalation~Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer: Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11052270|NCT01315678|EG001|Reported Event|TOBI®|"TOBI® is tobramycin inhalation solution~Tobramycin inhalation solution using a PARI LC® Plus nebulizer: 300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer.~Nebulization time is approximately 20 minutes for each administration.~Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment"
11052271|NCT01315847|BG000|Baseline|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
11052272|NCT01315847|BG001|Baseline|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
11052273|NCT01315847|BG002|Baseline|Total|Total of all reporting groups
11052274|NCT01315847|FG000|Participant Flow|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline positron emission tomography (PET) imaging of the brain using [11C]MK-4232 tracer (~300 megabecquerel [MBq]) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
11052275|NCT01315847|FG001|Participant Flow|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
11052276|NCT01315847|OG000|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
11052277|NCT01315847|OG000|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
11052278|NCT01315847|EG000|Reported Event|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
11052279|NCT01315847|EG001|Reported Event|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
11052280|NCT01316042|BG000|Baseline|Sugar Pill|2 pills per day for 12 months
11052281|NCT01316042|BG001|Baseline|Metformin|2 212.5mg pill/day for 12 months
11052282|NCT01316042|BG002|Baseline|Total|Total of all reporting groups
11052283|NCT01316042|FG000|Participant Flow|Sugar Pill|2 pills per day for 12 months
11052284|NCT01316042|FG001|Participant Flow|Metformin|2 212.5mg pill/day for 12 months
11052285|NCT01316042|OG000|Outcome|Sugar Pill|2 pills per day for 12 months
11052286|NCT01316042|OG001|Outcome|Metformin|2 212.5mg pill/day for 12 months
11052287|NCT01316042|EG000|Reported Event|Sugar Pill|2 pills per day for 12 months
11052288|NCT01316042|EG001|Reported Event|Metformin|2 212.5mg pill/day for 12 months
11052289|NCT01316055|BG000|Baseline|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052290|NCT01316055|BG001|Baseline|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052291|NCT01316055|BG002|Baseline|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052292|NCT01316055|BG003|Baseline|Total|Total of all reporting groups
11052293|NCT01316055|FG000|Participant Flow|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052294|NCT01316055|FG001|Participant Flow|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052295|NCT01316055|FG002|Participant Flow|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052296|NCT01316055|OG000|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052297|NCT01316055|OG001|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052298|NCT01316055|OG002|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052299|NCT01316055|OG000|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052300|NCT01316055|OG001|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052301|NCT01316055|OG002|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052302|NCT01316055|EG000|Reported Event|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052303|NCT01316055|EG001|Reported Event|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052304|NCT01316055|EG002|Reported Event|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
11052305|NCT01316211|BG000|Baseline|Coflex™|"Implantation of coflex™ device in assigned patients~Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis."
11052306|NCT01316211|BG001|Baseline|Surgical Decompression|"Surgical decompression in patients with spinal stenosis without stabilization by an additional implant.~Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant"
11052307|NCT01316211|BG002|Baseline|Total|Total of all reporting groups
11052308|NCT01316211|FG000|Participant Flow|Coflex™|"Implantation of coflex™ device in assigned patients~Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis."
11052309|NCT01316211|FG001|Participant Flow|Surgical Decompression|"Surgical decompression in patients with spinal stenosis without stabilization by an additional implant.~Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant"
11052310|NCT01316211|OG000|Outcome|Coflex™|"Implantation of coflex™ device in assigned patients~Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis."
11052311|NCT01316211|OG001|Outcome|Surgical Decompression|"Surgical decompression in patients with spinal stenosis without stabilization by an additional implant.~Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant"
11052312|NCT01316211|EG000|Reported Event|Coflex™|"Implantation of coflex™ device in assigned patients~Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis."
11052313|NCT01316211|EG001|Reported Event|Surgical Decompression|"Surgical decompression in patients with spinal stenosis without stabilization by an additional implant.~Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant"
11052314|NCT01316224|BG000|Baseline|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
11052315|NCT01316224|FG000|Participant Flow|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
11052316|NCT01316224|OG000|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
11052317|NCT01316224|EG000|Reported Event|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with Adalimumab
11052318|NCT01316263|BG000|Baseline|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
11052319|NCT01316263|BG001|Baseline|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
11052320|NCT01316263|BG002|Baseline|Total|Total of all reporting groups
11052321|NCT01316263|FG000|Participant Flow|PDGFRα Mutation Positive|20 milligrams per kilogram (mg/kg) of Olaratumab (IMC-3G3) was administered intravenously (IV) on Day 1 of each cycle (14-day cycles) to participants with gastrointestinal stromal tumors (GIST) with genotypes that had a platelet-derived growth factor receptor alpha (PDGFRα) mutation.
11052322|NCT01316263|FG001|Participant Flow|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
11052323|NCT01316263|OG000|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
11052324|NCT01316263|OG001|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
11052325|NCT01316263|OG000|Outcome|Olaratumab (IMC-3G3)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation or PDGFRα wild type.
11052326|NCT01316263|OG000|Outcome|PDGFRα Mutation Positive and Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation and that did not have a PDGFRα mutation.
11052327|NCT01316263|EG000|Reported Event|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
11052328|NCT01316263|EG001|Reported Event|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
11052329|NCT01316276|BG000|Baseline|LAI 590 mg QD|"590 mg LAI QD via a PARI Investigational eFlow® Nebulizer System (eFlow®) for 28 days followed by a 28-day off-treatment period. This cycle (28 days on treatment, 28 days off treatment) was to be repeated for up to 12 cycles, divided into 2 periods of 6 cycles each (approximately 12 months each).~Liposomal amikacin for inhalation: - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11149216|NCT01869647|BG000|Baseline|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
11052330|NCT01316276|FG000|Participant Flow|LAI 590 mg QD|"590 mg LAI once a day (QD) via a PARI Investigational eFlow® Nebulizer System (eFlow®) for 28 days followed by a 28-day off-treatment period. This cycle (28 days on treatment, 28 days off treatment) was to be repeated for up to 12 cycles, divided into 2 periods of 6 cycles each (approximately 12 months each).~Liposomal amikacin for inhalation (LAI): - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11052331|NCT01316276|OG000|Outcome|LAI 590 mg QD|"590 mg LAI QD via a PARI Investigational eFlow® Nebulizer System (eFlow®) for 28 days followed by a 28-day off-treatment period. This cycle (28 days on treatment, 28 days off treatment) was to be repeated for up to 12 cycles, divided into 2 periods of 6 cycles each (approximately 12 months each).~Liposomal amikacin for inhalation: - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11052332|NCT01316276|OG000|Outcome|LAI 590 mg QD|"590 mg LAI once a day (QD) via a PARI Investigational eFlow® Nebulizer System (eFlow®) for 28 days followed by a 28-day off-treatment period. This cycle (28 days on treatment, 28 days off treatment) was to be repeated for up to 12 cycles, divided into 2 periods of 6 cycles each (approximately 12 months each).~Liposomal amikacin for inhalation (LAI): - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11052333|NCT01316276|EG000|Reported Event|LAI 590 mg QD|"Liposomal amikacin for inhalation: - Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~Administration time is approximately 13 minutes.~Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
11052334|NCT01316302|BG000|Baseline|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
11052335|NCT01316302|BG001|Baseline|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
11052336|NCT01316302|BG002|Baseline|Total|Total of all reporting groups
11052337|NCT01316302|FG000|Participant Flow|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
11052338|NCT01316302|FG001|Participant Flow|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
11052339|NCT01316302|OG000|Outcome|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
11052340|NCT01316302|OG001|Outcome|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
11052341|NCT01316302|OG000|Outcome|Pristiq|Flexible dose, 50-100mg QD
11052342|NCT01316302|OG001|Outcome|Placebo|Matching placebo
11052343|NCT01316302|EG000|Reported Event|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
11052344|NCT01316302|EG001|Reported Event|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
11052345|NCT01316315|BG000|Baseline|Active|N6022 - 5 mg
11052346|NCT01316315|BG001|Baseline|Placebo|Non-Active
11052347|NCT01316315|BG002|Baseline|Total|Total of all reporting groups
11052348|NCT01316315|FG000|Participant Flow|Active|N6022 - Active 5 mg
11052349|NCT01316315|FG001|Participant Flow|Placebo|Non-Active
11052350|NCT01316315|OG000|Outcome|N6022|Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.
11052351|NCT01316315|OG001|Outcome|Placebo|Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
11052352|NCT01316315|OG000|Outcome|Active|N6022 - Active 5 mg
11052353|NCT01316315|OG001|Outcome|Placebo|Non-Active
11052354|NCT01316315|EG000|Reported Event|Active|N6022 - Active 5 mg
11052355|NCT01316315|EG001|Reported Event|Placebo|Non-Active
11052356|NCT01316341|BG000|Baseline|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
11052357|NCT01316341|BG001|Baseline|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
11052358|NCT01316341|BG002|Baseline|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
11052359|NCT01316341|BG003|Baseline|Total|Total of all reporting groups
11052360|NCT01316341|FG000|Participant Flow|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
11052361|NCT01316341|FG001|Participant Flow|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
11052362|NCT01316341|FG002|Participant Flow|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
11052363|NCT01316341|OG000|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
11052364|NCT01316341|OG001|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
11052365|NCT01316341|OG000|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
11052366|NCT01316341|OG001|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
11052367|NCT01316341|OG000|Outcome|Empa 10 mg|A single dose of 10 mg Empagliflozin (empa) taken orally, plus one placebo tablet.
11052368|NCT01316341|OG001|Outcome|Empa 25 mg|A single dose of 25 mg empagliflozin (empa) taken orally, plus one placebo tablet.
11052369|NCT01316341|OG000|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
11052370|NCT01316341|OG001|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
11052371|NCT01316341|OG002|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
11052372|NCT01316341|OG000|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
11052373|NCT01316341|OG001|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
11052374|NCT01316341|OG002|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
11052375|NCT01316341|EG000|Reported Event|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
11052376|NCT01316341|EG001|Reported Event|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
11052377|NCT01316341|EG002|Reported Event|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
11052378|NCT01316380|BG000|Baseline|Placebo|Patients treated with matching placebo
11052379|NCT01316380|BG001|Baseline|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
11052380|NCT01316380|BG002|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
11052381|NCT01316380|BG003|Baseline|Total|Total of all reporting groups
11052382|NCT01316380|FG000|Participant Flow|Placebo|Patients treated with matching placebo
11052383|NCT01316380|FG001|Participant Flow|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
11052384|NCT01316380|FG002|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
11052385|NCT01316380|OG000|Outcome|Placebo|Patients treated with matching placebo
10847010|NCT00281580|FG015|Participant Flow|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
10847011|NCT00281580|OG000|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
11052386|NCT01316380|OG001|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
11052387|NCT01316380|OG002|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
11052388|NCT01316380|EG000|Reported Event|Placebo|Enter description here, if needed
11052389|NCT01316380|EG001|Reported Event|Tio R2.5|Enter description here, if needed
11052390|NCT01316380|EG002|Reported Event|Tio R5|Enter description here, if needed
11052391|NCT01316419|BG000|Baseline|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
11052392|NCT01316419|FG000|Participant Flow|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
11052393|NCT01316419|OG000|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
11052394|NCT01316419|EG000|Reported Event|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
11052395|NCT01316510|BG000|Baseline|Bifidobacterium Infantis|"1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)~Bifidobacterium infantis: 1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge"
11052396|NCT01316510|BG001|Baseline|Placebo|"A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).~Placebo: Dilute Nutramigen formula"
11052397|NCT01316510|BG002|Baseline|Total|Total of all reporting groups
11052398|NCT01316510|FG000|Participant Flow|Bifidobacterium Infantis|"1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)~Bifidobacterium infantis: 1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge"
11052399|NCT01316510|FG001|Participant Flow|Placebo|"A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).~Placebo: Dilute Nutramigen formula"
11052400|NCT01316510|OG000|Outcome|Bifidobacterium Infantis|"1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)~Bifidobacterium infantis: 1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge"
11052401|NCT01316510|OG001|Outcome|Placebo|"A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).~Placebo: Dilute Nutramigen formula"
11052402|NCT01316510|EG000|Reported Event|Bifidobacterium Infantis|"1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)~Bifidobacterium infantis: 1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge"
11052403|NCT01316510|EG001|Reported Event|Placebo|"A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).~Placebo: Dilute Nutramigen formula"
11052404|NCT01316575|BG000|Baseline|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
11052405|NCT01316575|BG001|Baseline|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
11052406|NCT01316575|BG002|Baseline|Total|Total of all reporting groups
11052407|NCT01316575|FG000|Participant Flow|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
11052408|NCT01316575|FG001|Participant Flow|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
11052409|NCT01316575|OG000|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
11052410|NCT01316575|OG001|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
11052411|NCT01316575|EG000|Reported Event|nCPAP|
11052412|NCT01316575|EG001|Reported Event|Low Flow Oxygen|
11052413|NCT01316614|BG000|Baseline|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
11052414|NCT01316614|FG000|Participant Flow|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet. Only the order of the passes were randomized.
11052415|NCT01316614|OG000|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
11052416|NCT01316614|OG001|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
11052417|NCT01316614|EG000|Reported Event|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
11052418|NCT01316692|BG000|Baseline|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
11052419|NCT01316692|FG000|Participant Flow|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
11052420|NCT01316692|OG000|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
11052421|NCT01316692|EG000|Reported Event|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
11052422|NCT01316770|BG000|Baseline|Overall Study|Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening.
11052423|NCT01316770|FG000|Participant Flow|Dexamethasone Irrigation of Parotid Gland|Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
11052424|NCT01316770|FG001|Participant Flow|Placebo Irrigation of Parotid Gland|Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
11052425|NCT01316770|OG000|Outcome|Dexamethasone Irrigation of Parotid Gland|Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on Study Day 0 and Study Day 28.
11052426|NCT01316770|OG001|Outcome|Placebo Irrigation of Parotid Gland|Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
11052427|NCT01316770|OG000|Outcome|Dexamethasone Irrigation of Parotid Gland|Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
11052428|NCT01316770|OG000|Outcome|Overall Study|Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
11052429|NCT01316770|OG000|Outcome|All Study Participants|Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
11052430|NCT01316770|EG000|Reported Event|Dexamethasone Irrigation|Adverse event from the side of the mouth that received the parotid dexamethasone irrigation
11052431|NCT01316770|EG001|Reported Event|Placebo Irrigation|Adverse event from the side of the mouth that received the parotid placebo irrigation
11052432|NCT01316770|EG002|Reported Event|Side of Mouth Not Applicable|Side of mouth is not applicable to the adverse event
11052433|NCT01316887|BG000|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
11052434|NCT01316887|BG001|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
11052435|NCT01316887|BG002|Baseline|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
10847012|NCT00281580|OG001|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
11052436|NCT01316887|BG003|Baseline|Total|Total of all reporting groups
11052437|NCT01316887|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
11052438|NCT01316887|FG001|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
11052439|NCT01316887|FG002|Participant Flow|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
11052440|NCT01316887|OG000|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
11052441|NCT01316887|OG001|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
11052442|NCT01316887|OG002|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
11052443|NCT01316887|OG002|Outcome|UMEC/VI 125/25µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
11052444|NCT01316887|EG000|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.ve
11052445|NCT01316887|EG001|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
11052446|NCT01316887|EG002|Reported Event|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
11052447|NCT01316900|BG000|Baseline|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
11052448|NCT01316900|BG001|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
11052449|NCT01316900|BG002|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
11052450|NCT01316900|BG003|Baseline|Tiotropium 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
10847013|NCT00281580|OG002|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
10847014|NCT00281580|OG003|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
10847015|NCT00281580|OG000|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
11052451|NCT01316900|BG004|Baseline|Total|Total of all reporting groups
11052452|NCT01316900|FG000|Participant Flow|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
11052453|NCT01316900|FG001|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
11052454|NCT01316900|FG002|Participant Flow|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
11052455|NCT01316900|FG003|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
11052456|NCT01316900|OG000|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
11052457|NCT01316900|OG001|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
11052458|NCT01316900|OG002|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
11052459|NCT01316900|OG003|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
11052460|NCT01316900|EG000|Reported Event|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
11052461|NCT01316900|EG001|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
11052462|NCT01316900|EG002|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
11052463|NCT01316900|EG003|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
11052464|NCT01316913|BG000|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052465|NCT01316913|BG001|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11149217|NCT01869647|BG001|Baseline|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
11149218|NCT01869647|BG002|Baseline|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
11149219|NCT01869647|BG003|Baseline|Total|Total of all reporting groups
11149220|NCT01869647|FG000|Participant Flow|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
11149221|NCT01869647|FG001|Participant Flow|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
11149222|NCT01869647|FG002|Participant Flow|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
11149223|NCT01869647|OG000|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
11149224|NCT01869647|OG001|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
11149225|NCT01869647|OG002|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
11149226|NCT01869647|EG000|Reported Event|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
11149227|NCT01869647|EG001|Reported Event|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
11149228|NCT01869647|EG002|Reported Event|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
11149229|NCT01869686|BG000|Baseline|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
11149230|NCT01869686|FG000|Participant Flow|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
11149231|NCT01869686|OG000|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
11149232|NCT01869686|EG000|Reported Event|Denosumab 60 mg SC|
11149233|NCT01869699|BG000|Baseline|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
11149234|NCT01869699|BG001|Baseline|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
11149235|NCT01869699|BG002|Baseline|Total|Total of all reporting groups
11149236|NCT01869699|FG000|Participant Flow|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
10847016|NCT00281580|OG001|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
10847017|NCT00281580|OG002|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
10847018|NCT00281580|OG003|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
11052466|NCT01316913|BG002|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052467|NCT01316913|BG003|Baseline|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
11052468|NCT01316913|BG004|Baseline|Total|Total of all reporting groups
11052469|NCT01316913|FG000|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks.
11052470|NCT01316913|FG001|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052471|NCT01316913|FG002|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052472|NCT01316913|FG003|Participant Flow|TIO18 µg QD|Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
11052473|NCT01316913|OG000|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
10847019|NCT00281580|OG001|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
11052474|NCT01316913|OG001|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052475|NCT01316913|OG002|Outcome|UMEC/VI 125/25 QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052476|NCT01316913|OG003|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
11052477|NCT01316913|OG002|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052478|NCT01316913|EG000|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052479|NCT01316913|EG001|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052480|NCT01316913|EG002|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
11052481|NCT01316913|EG003|Reported Event|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
11052482|NCT01316926|BG000|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in period 1 and test product in period 2
11052483|NCT01316926|FG000|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
11052484|NCT01316926|FG001|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in Period 1; followed by test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
11052485|NCT01316926|OG000|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
11052486|NCT01316926|OG001|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods
11052487|NCT01316926|OG001|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
11052488|NCT01316926|EG000|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
11052489|NCT01316926|EG001|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
11052490|NCT01316939|BG000|Baseline|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
11052491|NCT01316939|BG001|Baseline|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
11052492|NCT01316939|BG002|Baseline|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
11052493|NCT01316939|BG003|Baseline|Total|Total of all reporting groups
11052494|NCT01316939|FG000|Participant Flow|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 milligram (mg) capsules.
11052495|NCT01316939|FG001|Participant Flow|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
10847020|NCT00281580|OG002|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
10847021|NCT00281580|OG003|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
11052496|NCT01316939|FG002|Participant Flow|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules twice daily (BID).
11052497|NCT01316939|OG000|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
11052498|NCT01316939|OG001|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
11052499|NCT01316939|OG002|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
11052500|NCT01316939|EG000|Reported Event|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
11052501|NCT01316939|EG001|Reported Event|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 milligram (mg) capsules once daily.
11052502|NCT01316939|EG002|Reported Event|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules twice daily (BID).
11052503|NCT01317004|BG000|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
11052504|NCT01317004|BG001|Baseline|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
11052505|NCT01317004|BG002|Baseline|Total|Total of all reporting groups
11052506|NCT01317004|FG000|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
11052507|NCT01317004|FG001|Participant Flow|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
10847022|NCT00281580|OG004|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
11052508|NCT01317004|OG000|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
11052509|NCT01317004|OG001|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
11052510|NCT01317004|EG000|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
11052511|NCT01317004|EG001|Reported Event|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
10847023|NCT00281580|OG005|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
11052512|NCT01317030|BG000|Baseline|Contact Lens Wear|"Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution~Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.~Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye."
11052513|NCT01317030|BG001|Baseline|Non-Contact Lens Wear|Non-Contact Lens Wear: No intervention
11052514|NCT01317030|BG002|Baseline|Total|Total of all reporting groups
11052515|NCT01317030|FG000|Participant Flow|Contact Lens Wear|"Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution~Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.~Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye."
11052516|NCT01317030|FG001|Participant Flow|Non-Contact Lens Wear|Non-Contact Lens Wear: No intervention
11052517|NCT01317030|OG000|Outcome|Contact Lens Wear|"Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution~Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.~Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye."
11052518|NCT01317030|OG001|Outcome|Non-Contact Lens Wear|Non-Contact Lens Wear: No intervention
11052519|NCT01317030|EG000|Reported Event|Contact Lens Wear|"Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution~Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.~Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye."
11052520|NCT01317030|EG001|Reported Event|Non-Contact Lens Wear|Non-Contact Lens Wear: No intervention
11052521|NCT01317095|BG000|Baseline|Wire Closure is the Intervention|"Patients will have their sternum closed using stainless steel wires.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
11052522|NCT01317095|BG001|Baseline|Rigid Fixation|"Patients will have their sternum closed by rigid fixation using Starnalock plates.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
11052523|NCT01317095|BG002|Baseline|Total|Total of all reporting groups
11052524|NCT01317095|FG000|Participant Flow|Rigid Fixation|"Patients will have their sternum closed by rigid fixation using Starnalock plates.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
11052525|NCT01317095|FG001|Participant Flow|Wire Closure is the Intervention|"Patients will have their sternum closed using stainless steel wires.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
11052526|NCT01317095|OG000|Outcome|Rigid Fixation|Patients will have their sternum closed by rigid fixation using Starnalock plates.
11052527|NCT01317095|OG001|Outcome|Wire Closure|Patients will have their sternum closed using stainless steel wires.
11052528|NCT01317095|EG000|Reported Event|Wire Closure is the Intervention|"Patients will have their sternum closed using stainless steel wires.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
11052529|NCT01317095|EG001|Reported Event|Rigid Fixation|"Patients will have their sternum closed by rigid fixation using Starnalock plates.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
11052530|NCT01317199|BG000|Baseline|Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)|Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
11052531|NCT01317199|BG001|Baseline|Phase 2: Placebo Control|Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
11052532|NCT01317199|BG002|Baseline|Phase 2: Low-dose MPX|Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
11052533|NCT01317199|BG003|Baseline|Phase 2: High-dose MPX|Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
11052534|NCT01317199|BG004|Baseline|Total|Total of all reporting groups
11052535|NCT01317199|FG000|Participant Flow|Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)|Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
11052536|NCT01317199|FG001|Participant Flow|Phase 2: Placebo Control|Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
11052537|NCT01317199|FG002|Participant Flow|Phase 2: Low-dose MPX|Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
11052538|NCT01317199|FG003|Participant Flow|Phase 2: High-dose MPX|Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
11052539|NCT01317199|OG000|Outcome|Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)|Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
11052540|NCT01317199|OG001|Outcome|Phase 2: Placebo Control|Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
11052541|NCT01317199|OG002|Outcome|Phase 2: Low-dose MPX|Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
11052542|NCT01317199|OG003|Outcome|Phase 2: High-dose MPX|Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
11052543|NCT01317199|OG000|Outcome|Phase 2: Placebo Control|Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
11052544|NCT01317199|OG001|Outcome|Phase 2: Low-dose MPX|Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
11052545|NCT01317199|OG002|Outcome|Phase 2: High-dose MPX|Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
11052546|NCT01317199|EG000|Reported Event|Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg|Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
11052547|NCT01317199|EG001|Reported Event|Dose-escalation Phase 1: MPX 1000mg|Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
11052548|NCT01317199|EG002|Reported Event|Dose-escalation Phase 1: MPX 2000mg|Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
11052549|NCT01317199|EG003|Reported Event|Dose-escalation Phase 1: MPX 3000mg|Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
11052550|NCT01317199|EG004|Reported Event|Dose-escalation Phase 1: MPX 4000mg|Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
11052551|NCT01317199|EG005|Reported Event|Phase 2: Placebo Control|Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
11052552|NCT01317199|EG006|Reported Event|Phase 2: Low-dose MPX|Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
11052553|NCT01317199|EG007|Reported Event|Phase 2: High-dose MPX|Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
11149237|NCT01869699|FG001|Participant Flow|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
11052554|NCT01317277|BG000|Baseline|iTAB + Psychoeducation|"individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive daily text messages to assess mood and methamphetamine use.~Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications."
11052555|NCT01317277|BG001|Baseline|Psychoeducation|"Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.~Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence."
11052556|NCT01317277|BG002|Baseline|Total|Total of all reporting groups
11052557|NCT01317277|FG000|Participant Flow|iTAB + Psychoeducation|"individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive daily text messages to assess mood and methamphetamine use.~Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications."
11052558|NCT01317277|FG001|Participant Flow|Psychoeducation|"Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.~Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence."
11052559|NCT01317277|OG000|Outcome|iTAB + Psychoeducation|"Participants in the individualized Texting for Adherence Building (iTAB) arm will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.~individualized Texting for Adherence Building (iTAB): Intervention is designed to send automated text messages to HIV+ persons who are current methamphetamine (METH+) users. Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART medications among HIV+/METH+ persons above and beyond an active comparator group."
11052560|NCT01317277|OG001|Outcome|Psychoeducation|"Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications. They will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.~Psychoeducation: Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence."
11052561|NCT01317277|EG000|Reported Event|iTAB + Psychoeducation|"Participants in the individualized Texting for Adherence Building (iTAB) arm will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.~individualized Texting for Adherence Building (iTAB): Intervention is designed to send automated text messages to HIV+ persons who are current methamphetamine (METH+) users. Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART medications among HIV+/METH+ persons above and beyond an active comparator group."
11052562|NCT01317277|EG001|Reported Event|Psychoeducation|"Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications. They will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.~Psychoeducation: Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence."
11052563|NCT01317472|BG000|Baseline|Dexlansoprazole|"Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).~dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months"
11052564|NCT01317472|BG001|Baseline|Sugar Pill|"Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC).~dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months"
11052565|NCT01317472|BG002|Baseline|Total|Total of all reporting groups
11052566|NCT01317472|FG000|Participant Flow|Dexlansoprazole|"Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).~dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months"
11052567|NCT01317472|FG001|Participant Flow|Sugar Pill|"Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC).~dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months"
11052568|NCT01317472|OG000|Outcome|Dexlansoprazole|"Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).~dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months"
11052569|NCT01317472|OG001|Outcome|Sugar Pill|"Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC).~dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months"
11052570|NCT01317472|EG000|Reported Event|Dexlansoprazole|"Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).~dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months"
11052571|NCT01317472|EG001|Reported Event|Sugar Pill|"Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC).~dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months"
11052572|NCT01317550|BG000|Baseline|Armodafinil|Armodafinil 150mg (capsule) once a day during entire course of radiation therapy for 10 weeks
11052573|NCT01317550|BG001|Baseline|Minocycline|Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy for 10 weeks
11052574|NCT01317550|BG002|Baseline|Armodafinil+Minocycline|Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks
11052575|NCT01317550|BG003|Baseline|Matching Placebo|Placebo capsules orally once/day for 10 weeks
10847024|NCT00281580|OG006|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
11052576|NCT01317550|BG004|Baseline|Total|Total of all reporting groups
11052577|NCT01317550|FG000|Participant Flow|Armodafinil|Armodafinil 150mg (capsule) once a day during entire course of radiation therapy for 10 weeks
11052578|NCT01317550|FG001|Participant Flow|Minocycline|Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy for 10 weeks
11052579|NCT01317550|FG002|Participant Flow|Armodafinil + Minocycline|Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks
11052580|NCT01317550|FG003|Participant Flow|Matching Placebo|Placebo capsules orally once/day for 10 weeks
11226562|NCT02376283|OG002|Outcome|Ticagrelor|"STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226563|NCT02376283|OG003|Outcome|Ticagrelor Parent Compound|STEMI/NSTEMI patients. (Ticagrelor was used in our centre only after the use of prasugrel was discontinued) The parent compound was also analysed as it is a directly acting agent that does not require metabolic conversion to its active form
11226564|NCT02376283|EG000|Reported Event|Clopidogrel|"STEMI (n = 14) and NSTEMI (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226565|NCT02376283|EG001|Reported Event|Prasugrel|"STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11226566|NCT02376283|EG002|Reported Event|Ticagrelor|"STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.~The participants involvement in the study ceased following the collection of the 240-minute blood sample."
11052581|NCT01317550|OG000|Outcome|Armodafinil|Armodafinil 150mg (capsule) once a day during entire course of radiation therapy (10 weeks + 2 days
11052582|NCT01317550|OG001|Outcome|Minocycline|Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (10 weeks + 2 days)
11052583|NCT01317550|OG002|Outcome|Armodafinil+Minocycline|Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks
11226567|NCT02376361|BG000|Baseline|Surveillance Group|"Monthly blood flow surveillance by ultrasound dilution technique and standard of care.~Transonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).~Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines~Recirculation, access flow will be performed according to HD03 Manual.~Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist."
10847025|NCT00281580|OG007|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
11052584|NCT01317550|OG003|Outcome|Matching Placebo|Placebo Capsules orally once/day for 10 weeks
11052585|NCT01317550|EG000|Reported Event|Armodafinil + Placebo|Armodafinil orally 150 mg/day + Placebo capsules for 10 weeks
11052586|NCT01317550|EG001|Reported Event|Minocycline + Placebo|Minocycline orally 100 mg twice/day + Placebo capsules for 10 weeks
11052587|NCT01317550|EG002|Reported Event|Armodafinil + Minocycline|Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks
11052588|NCT01317550|EG003|Reported Event|Placebos|Placebo Capsules orally once/day for 10 weeks
11052589|NCT01317615|BG000|Baseline|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
11052590|NCT01317615|FG000|Participant Flow|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
11052591|NCT01317615|OG000|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
11052592|NCT01317615|EG000|Reported Event|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
11052593|NCT01317641|BG000|Baseline|Phase 1, 200mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
11052594|NCT01317641|BG001|Baseline|Phase 1, 400mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
11052595|NCT01317641|BG002|Baseline|Phase 1, 600mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
11052596|NCT01317641|BG003|Baseline|Phase 1, 1000mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
11052597|NCT01317641|BG004|Baseline|Phase 1, 1400mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
11052598|NCT01317641|BG005|Baseline|Phase 1, 1800mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
11226568|NCT02376361|BG001|Baseline|Control Group|Control group will receive standard monitoring (standard care).
11226569|NCT02376361|BG002|Baseline|Total|Total of all reporting groups
11052599|NCT01317641|BG006|Baseline|Phase 2 (200mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously
11052600|NCT01317641|BG007|Baseline|Phase 2 (400mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
11052601|NCT01317641|BG008|Baseline|Phase 2 (1400mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
11052602|NCT01317641|BG009|Baseline|Total|Total of all reporting groups
11052603|NCT01317641|FG000|Participant Flow|Phase 1: ODM-201 200 mg/Day|Dose escalation
10847026|NCT00281580|OG008|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
11052604|NCT01317641|FG001|Participant Flow|Phase 1: ODM-201 400 mg/Day|Dose escalation
11052605|NCT01317641|FG002|Participant Flow|Phase 1: ODM-201 600 mg/Day|Dose escalation
11052606|NCT01317641|FG003|Participant Flow|Phase 1: ODM-201 1000 mg/Day|Dose escalation
11052607|NCT01317641|FG004|Participant Flow|Phase 1: ODM-201 1400 mg/Day|Dose escalation
11052608|NCT01317641|FG005|Participant Flow|Phase 1: ODM-201 1800 mg/Day|Dose escalation
11052609|NCT01317641|FG006|Participant Flow|Phase 2: ODM-201 200mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
11052610|NCT01317641|FG007|Participant Flow|Phase 2: ODM-201 400mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
11052611|NCT01317641|FG008|Participant Flow|Phase 2: ODM-201 1400mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
11052612|NCT01317641|OG000|Outcome|Phase 1: ODM-201 200 mg/Day|Participants received twice daily of oral ODM-201 continuously.
11052613|NCT01317641|OG001|Outcome|Phase 1: ODM-201 400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
11052614|NCT01317641|OG002|Outcome|Phase 1: ODM-201 600 mg/Day|Participants received twice daily of oral ODM-201 continuously.
11052615|NCT01317641|OG003|Outcome|Phase 1: ODM-201 1000 mg/Day|Participants received twice daily of oral ODM-201 continuously.
11052616|NCT01317641|OG004|Outcome|Phase 1: ODM-201 1400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
11052617|NCT01317641|OG005|Outcome|Phase 1: ODM-201 1800 mg/Day|Participants received twice daily of oral ODM-201 continuously.
11052618|NCT01317641|OG000|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
11052619|NCT01317641|OG001|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
11052620|NCT01317641|OG002|Outcome|600mg/Day ODM-201|phase 1
11052621|NCT01317641|OG003|Outcome|1000mg/Day ODM-201|phase 1
11052622|NCT01317641|OG004|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
11052623|NCT01317641|OG005|Outcome|1800mg/Day ODM-201|phase 1
11052624|NCT01317641|OG002|Outcome|600mg/Day ODM-201|Phase 1
11052625|NCT01317641|OG003|Outcome|1000mg/Day ODM-201|Phase 1
11052626|NCT01317641|OG005|Outcome|1800mg/Day ODM-201|Phase 1
11052627|NCT01317641|OG002|Outcome|1000mg/Day ODM-201|Phase 1
11052628|NCT01317641|OG003|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
11052629|NCT01317641|OG004|Outcome|1800mg/Day ODM-201|Phase 1
11052630|NCT01317641|OG002|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
11052631|NCT01317641|OG000|Outcome|200 mg/Day ODM-201|Phase 1
11052632|NCT01317641|OG001|Outcome|400 mg/Day ODM-201|Phase 1
11052633|NCT01317641|OG002|Outcome|600 mg/Day ODM-201|Phase 1
11052634|NCT01317641|OG003|Outcome|1000 mg/Day ODM-201|Phase 1
11052635|NCT01317641|OG004|Outcome|1400 mg/Day ODM-201|Phase 1
11052636|NCT01317641|OG005|Outcome|1800 mg/Day ODM-201|Phase 1
11052637|NCT01317641|EG000|Reported Event|Phase 1, 200mg/Day ODM-201|Dose escalation
11052638|NCT01317641|EG001|Reported Event|Phase 1, 400mg/Day ODM-201|Dose escalation
11052639|NCT01317641|EG002|Reported Event|Phase 1, 600mg/Day ODM-201|Dose escalation
11052640|NCT01317641|EG003|Reported Event|Phase 1, 1000mg/Day ODM-201|Dose escalation
11052641|NCT01317641|EG004|Reported Event|Phase 1, 1400mg/Day ODM-201|Dose escalation
11052642|NCT01317641|EG005|Reported Event|Phase 1, 1800mg/Day ODM-201|Dose escalation
11052643|NCT01317641|EG006|Reported Event|Phase 2, 200mg/Day ODM-201|Dose expansion
11052644|NCT01317641|EG007|Reported Event|Phase 2, 400mg/Day ODM-201|Dose expansion
11052645|NCT01317641|EG008|Reported Event|Phase 2, 1400mg/Day ODM-201|Dose expansion
11052646|NCT01317667|BG000|Baseline|Group 1|RVEc vaccine 20 μg/dose x 3 doses
11052647|NCT01317667|BG001|Baseline|Group 2|RVEc vaccine 50 μg/dose x 3 doses
11052648|NCT01317667|BG002|Baseline|Group 3|RVEc vaccine 100 μg/dose x 1 dose
11052649|NCT01317667|BG003|Baseline|Total|Total of all reporting groups
11052650|NCT01317667|FG000|Participant Flow|Group 1|RVEc vaccine 20 μg/dose x 3 doses
11052651|NCT01317667|FG001|Participant Flow|Group 2|RVEc vaccine 50 μg/dose x 3 doses
11052652|NCT01317667|FG002|Participant Flow|Group 3|RVEc vaccine 100 μg/dose x 1 dose
11052653|NCT01317667|OG000|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
11052654|NCT01317667|OG001|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
11052655|NCT01317667|OG002|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
11052656|NCT01317667|EG000|Reported Event|Group 1|RVEc vaccine 20 μg/dose x 3 doses
11052657|NCT01317667|EG001|Reported Event|Group 2|RVEc vaccine 50 μg/dose x 3 doses
11052658|NCT01317667|EG002|Reported Event|Group 3|RVEc vaccine 100 μg/dose x 1 dose
11052659|NCT01317797|BG000|Baseline|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
11052660|NCT01317797|BG001|Baseline|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
11052661|NCT01317797|BG002|Baseline|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
11052662|NCT01317797|BG003|Baseline|Total|Total of all reporting groups
11052663|NCT01317797|FG000|Participant Flow|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
11149238|NCT01869699|OG000|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
11149239|NCT01869699|OG001|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
11149240|NCT01869699|EG000|Reported Event|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
11149241|NCT01869699|EG001|Reported Event|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
11149242|NCT01869725|BG000|Baseline|Diagnostic (Gallium Ga 68-edotreotide PET/CT)|"Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.~gallium Ga 68-edotreotide: Given IV~positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan~indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan~computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan~contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan"
11149243|NCT01869725|FG000|Participant Flow|Diagnostic (Gallium Ga 68-edotreotide PET/CT)|"Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.~gallium Ga 68-edotreotide: Given IV~positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan~indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan~computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan~contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan"
11149244|NCT01869725|OG000|Outcome|Diagnostic (Gallium Ga 68-edotreotide PET/CT)|"Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.~gallium Ga 68-edotreotide: Given IV~positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan~indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan~computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan~contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan"
11149245|NCT01869725|EG000|Reported Event|Diagnostic (Gallium Ga 68-edotreotide PET/CT)|"Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.~gallium Ga 68-edotreotide: Given IV~positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan~indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan~computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan~contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan"
11149246|NCT01869764|BG000|Baseline|Arm I (Omega-3 Fatty Acid)|"Patients receive omega-3 fatty acid PO daily for 7-14 days.~omega-3 fatty acid: Given PO~laboratory biomarker analysis: Correlative studies"
11149247|NCT01869764|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO daily for 7-14 days.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11149248|NCT01869764|BG002|Baseline|Total|Total of all reporting groups
11149249|NCT01869764|FG000|Participant Flow|Arm I (Omega-3 Fatty Acid)|"Patients receive omega-3 fatty acid PO daily for 7-14 days.~omega-3 fatty acid: Given PO~laboratory biomarker analysis: Correlative studies"
11149250|NCT01869764|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO daily for 7-14 days.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11149251|NCT01869764|OG000|Outcome|Arm I (Omega-3 Fatty Acid)|"Patients receive omega-3 fatty acid PO daily for 7-14 days.~omega-3 fatty acid: Given PO~laboratory biomarker analysis: Correlative studies"
11149252|NCT01869764|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO daily for 7-14 days.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11149253|NCT01869764|EG000|Reported Event|Arm I (Omega-3 Fatty Acid)|"Patients receive omega-3 fatty acid PO daily for 7-14 days.~omega-3 fatty acid: Given PO~laboratory biomarker analysis: Correlative studies"
11149254|NCT01869764|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO daily for 7-14 days.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11149255|NCT01869777|BG000|Baseline|Diagnostic (Bioelectric Impedance Analysis)|"Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement just prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, PICC line placement, etc.).~bioelectric impedance analysis: Undergo bioelectric impedance analysis"
11149256|NCT01869777|FG000|Participant Flow|Diagnostic (Bioelectric Impedance Analysis)|"Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement just prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, PICC line placement, etc.).~bioelectric impedance analysis: Undergo bioelectric impedance analysis"
10847027|NCT00281580|OG009|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
10847028|NCT00281580|OG010|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
10847029|NCT00281580|OG011|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
11052664|NCT01317797|FG001|Participant Flow|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
11052665|NCT01317797|FG002|Participant Flow|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
11052666|NCT01317797|OG000|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
11052667|NCT01317797|OG001|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
11052668|NCT01317797|OG002|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
11052669|NCT01317797|EG000|Reported Event|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
11052670|NCT01317797|EG001|Reported Event|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
11052671|NCT01317797|EG002|Reported Event|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
11052672|NCT01317901|BG000|Baseline|TRU-016 (10 mg/kg) +Bendamustine+Rituximab|
11052673|NCT01317901|BG001|Baseline|TRU-016 (20 mg/kg) +Bendamustine+Rituximab|
11052674|NCT01317901|BG002|Baseline|Total|Total of all reporting groups
11052675|NCT01317901|FG000|Participant Flow|10 mg/kg TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m^2 rituximab was administered by IV infusion on Day 2 of each cycle.~Bendamustine: 90 mg/m^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
11052676|NCT01317901|FG001|Participant Flow|20 mg/kg TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m^2 rituximab was administered by IV infusion on Day 2 of each cycle.~Bendamustine: 90 mg/m^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
11052677|NCT01317901|OG000|Outcome|TRU-016 (10 mg/kg) + Bendamustine + Rituximab|"10 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.~TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle~Bendamustine: Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.~Rituximab: Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle."
11052678|NCT01317901|OG001|Outcome|20 mg/kg of TRU 016 + Bendamustine + Rituximab|20 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
11052679|NCT01317901|EG000|Reported Event|TRU-016 (10 mg/kg)|TRU-016 (10 mg/kg) + bendamustine + rituximab
11052680|NCT01317901|EG001|Reported Event|TRU-016 (20 mg/kg)|TRU-016 (20 mg/kg) + bendamustine + rituximab
11052681|NCT01317940|BG000|Baseline|On Therapy Intervention (Group A)|"Subjects randomized following Induction to receive education plus:~Vitamin D and Calcium Citrate: Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6-7 months)P"
11052682|NCT01317940|BG001|Baseline|On Therapy Standard of Care (Group A)|Subjects randomized following Induction to receive standard of care with education alone
11052683|NCT01317940|BG002|Baseline|"On Therapy Natural History (Group A)"|Subjects surviving to end of Induction but ineligible for randomization for any reason
11052684|NCT01317940|BG003|Baseline|Survivorship Intervention (Group B)|"Survivors to receive education plus:~Vitamin D and Calcium Citrate: Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6 months)"
11052685|NCT01317940|BG004|Baseline|Survivorship Standard of Care (Group B)|Survivors either randomized to received standard of care with education alone OR vitamin D sufficient and continued for follow-up only.
11052686|NCT01317940|BG005|Baseline|Siblings (Group C)|Healthy siblings of subjects in Group A
11052687|NCT01317940|BG006|Baseline|Total|Total of all reporting groups
11052688|NCT01317940|FG000|Participant Flow|On-Therapy Intervention (Group A)|"Subjects randomized following Induction to receive education plus:~Vitamin D and Calcium Citrate: Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6-7 months)P"
11052689|NCT01317940|FG001|Participant Flow|On Therapy Standard of Care (Group A)|"Subjects randomized following Induction to receive standard of care with education alone OR subjects ineligible for open-label randomization and followed as natural history cohort."
11052690|NCT01317940|FG002|Participant Flow|"On-Therapy Natural History (Group A)"|Patients enrolled prior to open-label randomization and those not eligible for randomization at end of induction
11052691|NCT01317940|FG003|Participant Flow|Survivorship Intervention (Group B)|Subjects randomized to receive education plus directly-observed therapy with open-label Vitamin D and chewable calcium
11052692|NCT01317940|FG004|Participant Flow|Survivorship Standard of Care (Group B)|Survivors randomized to receive standard of care with education alone OR subjects ineligible for open-label Vitamin D+ Calcium randomization and continued with follow-up only.
10847030|NCT00281580|OG012|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
10847031|NCT00281580|OG013|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
11052693|NCT01317940|FG005|Participant Flow|Siblings of Survivors (Group C)|Healthy siblings of survivors of pediatric acute lymphoblastic leukemia (ALL) for one-time assessment
11052694|NCT01317940|OG000|Outcome|On-Therapy Intervention (Group A)|"Subjects randomized following Induction to receive education plus:~Vitamin D and Calcium Citrate: Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6-7 months)P"
11052695|NCT01317940|OG001|Outcome|On Therapy Standard of Care (Group A)|"Subjects randomized following Induction to receive standard of care with education alone OR subjects ineligible for open-label randomization and followed as natural history cohort."
11052696|NCT01317940|OG002|Outcome|"On-Therapy Natural History (Group A)"|Patients enrolled prior to open-label randomization and those not eligible for randomization at end of induction
11052697|NCT01317940|OG002|Outcome|"On-Therapy Natural History (Group A, Tibia)"|Patients enrolled prior to open-label randomization and those not eligible for randomization at end of induction
11052698|NCT01317940|OG000|Outcome|Survivorship Intervention (Group B)|Subjects randomized to receive education plus directly-observed therapy with open-label Vitamin D and chewable calcium
11052699|NCT01317940|OG001|Outcome|Survivorship Standard of Care (Group B)|Survivors randomized to receive standard of care with education alone OR subjects ineligible for open-label Vitamin D+ Calcium randomization and continued with follow-up only.
11052700|NCT01317940|OG000|Outcome|Siblings of Survivors (Group C)|Healthy siblings of survivors of pediatric ALL for one-time assessment
11052701|NCT01317940|OG001|Outcome|Newly Diagnosed Patients (Group A)|Siblings enrolled in trial (Group A)
11052702|NCT01317940|EG000|Reported Event|On Therapy Intervention (Group A)|"Subjects randomized following Induction to receive education plus:~Vitamin D and Calcium Citrate: Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6 months)"
11052703|NCT01317940|EG001|Reported Event|On Therapy Standard of Care (Group A)|Subjects randomized following Induction to receive standard of care with education alone
11052704|NCT01317940|EG002|Reported Event|Survivorship Intervention (Group B)|Survivors randomized to receive directly-observed therapy with open-label Vitamin and chewable calcium
11052705|NCT01317940|EG003|Reported Event|Survivorship Standard of Care (Group B)|Survivors randomized to receive standard of care with education alone OR ineligible for open-label Vitamin D+Calcium randomization
11052706|NCT01317940|EG004|Reported Event|Siblings of Group A (Group C)|Singling of Group A were enrolled for a one-time visit for labs; All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
11052707|NCT01318018|BG000|Baseline|Magnetic Seizure Therapy Group|Patients receiving magnetic seizure therapy for depression
11052708|NCT01318018|BG001|Baseline|Electroconvulsive Therapy Group|Patients receiving electroconvulsive therapy for depression
11052709|NCT01318018|BG002|Baseline|Total|Total of all reporting groups
11052710|NCT01318018|FG000|Participant Flow|Magnetic Seizure Therapy Group|Patients receiving magnetic seizure therapy for depression completed
11052711|NCT01318018|FG001|Participant Flow|Electroconvulsive Therapy Group|Patients receiving electroconvulsive therapy for depression
11052712|NCT01318018|OG000|Outcome|Magnetic Seizure Therapy Group|Patients receiving magnetic seizure therapy for depression recovery time
11052713|NCT01318018|OG001|Outcome|Electroconvulsive Therapy Group|Patients receiving electroconvulsive therapy for depression recovery time
11052714|NCT01318018|EG000|Reported Event|Magnetic Seizure Therapy Group|Patients receiving magnetic seizure therapy for depression: None
11052715|NCT01318018|EG001|Reported Event|Electroconvulsive Therapy Group|Patients receiving electroconvulsive therapy for depression: None
11052716|NCT01318070|BG000|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052717|NCT01318070|BG001|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052718|NCT01318070|BG002|Baseline|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052719|NCT01318070|BG003|Baseline|Total|Total of all reporting groups
11052720|NCT01318070|FG000|Participant Flow|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052721|NCT01318070|FG001|Participant Flow|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052722|NCT01318070|FG002|Participant Flow|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052723|NCT01318070|OG000|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052724|NCT01318070|OG001|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052725|NCT01318070|OG002|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052726|NCT01318070|EG000|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052727|NCT01318070|EG001|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052728|NCT01318070|EG002|Reported Event|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
11052729|NCT01318083|BG000|Baseline|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
11052730|NCT01318083|BG001|Baseline|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
11052731|NCT01318083|BG002|Baseline|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
11052732|NCT01318083|BG003|Baseline|Total|Total of all reporting groups
11052733|NCT01318083|FG000|Participant Flow|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
11052734|NCT01318083|FG001|Participant Flow|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
11052735|NCT01318083|FG002|Participant Flow|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
11052736|NCT01318083|OG000|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
11052737|NCT01318083|OG001|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
11052738|NCT01318083|OG002|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
11052739|NCT01318083|EG000|Reported Event|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
11052740|NCT01318083|EG001|Reported Event|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
11052741|NCT01318083|EG002|Reported Event|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
11052742|NCT01318109|BG000|Baseline|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
11052743|NCT01318109|BG001|Baseline|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
10847032|NCT00281580|OG014|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
11052744|NCT01318109|BG002|Baseline|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
11052745|NCT01318109|BG003|Baseline|Total|Total of all reporting groups
11052746|NCT01318109|FG000|Participant Flow|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
11052747|NCT01318109|FG001|Participant Flow|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
11052748|NCT01318109|FG002|Participant Flow|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
11052749|NCT01318109|OG000|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
11052750|NCT01318109|OG001|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
11052751|NCT01318109|OG002|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
11052752|NCT01318109|EG000|Reported Event|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
11052753|NCT01318109|EG001|Reported Event|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
11052754|NCT01318109|EG002|Reported Event|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
11052755|NCT01318122|BG000|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
11052756|NCT01318122|BG001|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
11052757|NCT01318122|BG002|Baseline|Total|Total of all reporting groups
11052758|NCT01318122|FG000|Participant Flow|CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
11052759|NCT01318122|FG001|Participant Flow|CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
11052760|NCT01318122|FG002|Participant Flow|Pioglitazone Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
11052761|NCT01318122|FG003|Participant Flow|Pioglitazone Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
11052762|NCT01318122|OG000|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
11052763|NCT01318122|OG001|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
11052764|NCT01318122|EG000|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
11052765|NCT01318122|EG001|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
11052766|NCT01318135|BG000|Baseline|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
11052767|NCT01318135|BG001|Baseline|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
11052768|NCT01318135|BG002|Baseline|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
11052769|NCT01318135|BG003|Baseline|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
11052770|NCT01318135|BG004|Baseline|Total|Total of all reporting groups
11052771|NCT01318135|FG000|Participant Flow|CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
11052772|NCT01318135|FG001|Participant Flow|CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
11052773|NCT01318135|FG002|Participant Flow|Glimepiride Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
11052774|NCT01318135|FG003|Participant Flow|Glimepiride Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
11052775|NCT01318135|FG004|Participant Flow|CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
11052776|NCT01318135|FG005|Participant Flow|CCT/006 - 25 mg Dose Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
11052777|NCT01318135|FG006|Participant Flow|Metformin Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
11052778|NCT01318135|FG007|Participant Flow|Metformin Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
11052779|NCT01318135|OG000|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
11052780|NCT01318135|OG001|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
11052781|NCT01318135|OG002|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
11052782|NCT01318135|OG003|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
11052783|NCT01318135|EG000|Reported Event|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
11052784|NCT01318135|EG001|Reported Event|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
11052785|NCT01318135|EG002|Reported Event|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
11226570|NCT02376361|FG000|Participant Flow|Surveillance Group|"Monthly blood flow surveillance by ultrasound dilution technique and standard of care.~Transonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).~Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines~Recirculation, access flow will be performed according to HD03 Manual.~Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist."
11226571|NCT02376361|FG001|Participant Flow|Control Group|Control group will receive standard monitoring (standard care).
11226572|NCT02376361|OG000|Outcome|Surveillance Group|"Monthly blood flow surveillance by ultrasound dilution technique and standard of care.~Transonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).~Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines~Recirculation, access flow will be performed according to HD03 Manual.~Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist."
11226573|NCT02376361|OG001|Outcome|Control Group|Control group will receive standard monitoring (standard care).
11226574|NCT02376361|EG000|Reported Event|Surveillance Group|Monthly standard of care and blood flow surveillance for the duration of the study
11226575|NCT02376361|EG001|Reported Event|Control Group|Monthly standard of care for the duration of the study
11226576|NCT02376530|BG000|Baseline|Usual Shopping|No change in condition.
11226577|NCT02376530|BG001|Baseline|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
11226578|NCT02376530|BG002|Baseline|Price Change|Price changes will be present during shopping session.
11226579|NCT02376530|BG003|Baseline|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
11226580|NCT02376530|BG004|Baseline|Total|Total of all reporting groups
11226581|NCT02376530|FG000|Participant Flow|Usual Shopping|No change in condition.
11226582|NCT02376530|FG001|Participant Flow|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
11226583|NCT02376530|FG002|Participant Flow|Price Change|Price changes will be present during shopping session.
11226584|NCT02376530|FG003|Participant Flow|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
11226585|NCT02376530|OG000|Outcome|Usual Shopping|No change in condition.
11226586|NCT02376530|OG001|Outcome|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
11226587|NCT02376530|OG002|Outcome|Price Change|Price changes will be present during shopping session.
11226588|NCT02376530|OG003|Outcome|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
11226589|NCT02376530|EG000|Reported Event|Usual Shopping|No change in condition.
11226590|NCT02376530|EG001|Reported Event|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
11226591|NCT02376530|EG002|Reported Event|Price Change|Price changes will be present during shopping session.
11226592|NCT02376530|EG003|Reported Event|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
11226593|NCT02376790|BG000|Baseline|Methotrexate Monotherapy|Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
11226594|NCT02376790|BG001|Baseline|Etanercept Monotherapy|Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
11226595|NCT02376790|BG002|Baseline|Etanercept + Methotrexate|Participants received etanercept 50 mg a week by subcutaneous injection and oral methotrexate 20 mg a week for 48 weeks.
11226596|NCT02376790|BG003|Baseline|Total|Total of all reporting groups
11226597|NCT02376790|FG000|Participant Flow|Methotrexate Monotherapy|Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
11226598|NCT02376790|FG001|Participant Flow|Etanercept Monotherapy|Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
11226599|NCT02376790|FG002|Participant Flow|Etanercept + Methotrexate|Participants received etanercept 50 mg a week by subcutaneous injection and oral methotrexate 20 mg a week for 48 weeks.
11226600|NCT02376790|OG000|Outcome|Methotrexate Monotherapy|Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
11226601|NCT02376790|OG001|Outcome|Etanercept Monotherapy|Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
11226602|NCT02376790|OG002|Outcome|Etanercept + Methotrexate|Participants received etanercept 50 mg a week by subcutaneous injection and oral methotrexate 20 mg a week for 48 weeks.
11226603|NCT02376790|EG000|Reported Event|Methotrexate Monotherapy|Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
11226604|NCT02376790|EG001|Reported Event|Etanercept Monotherapy|Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
11226605|NCT02376790|EG002|Reported Event|Etanercept + Methotrexate|Participants received etanercept 50 mg a week by subcutaneous injection and oral methotrexate 20 mg a week for 48 weeks.
11226606|NCT02376998|BG000|Baseline|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
11226607|NCT02376998|FG000|Participant Flow|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
11226608|NCT02376998|OG000|Outcome|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta. Mortality 0%
11341937|NCT03693742|FG001|Participant Flow|Placebo, Then MSG|"After a fasting period of 4 hours, participants first received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.~Within 1 week, participants returned and after having fasted for 4 hours, then received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan."
11052786|NCT01318135|EG003|Reported Event|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
11226609|NCT02376998|EG000|Reported Event|Valiant™ Endoluminal Procedure|"Data from early and long term complications following endoluminal stent-graft placement for thoracic endovascular aortic repair (TEVAR) procedure (Valiant™ endoluminal procedure) will be collected.~Valiant™ endoluminal procedure: Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows:~The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions.~After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak."
11226610|NCT02377063|BG000|Baseline|Pressed Juice|"Subjects will consume pressed juice supplementation for 3 days~Pressed Juice: Subjects will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool samples will be collected at baseline, day 4 and day 17."
11226611|NCT02377063|FG000|Participant Flow|Pressed Juice|"Subjects will consume pressed juice supplementation for 3 days~Pressed Juice: Subjects will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool samples will be collected at baseline, day 4 and day 17."
11226612|NCT02377063|OG000|Outcome|Mixed Fruit and Vegetable Juice 6 Bottles|All participants consumed 6 bottles of mixed fruit and vegetable juice daily for 3 days.
11226613|NCT02377063|EG000|Reported Event|Pressed Juice|"Subjects will consume pressed juice supplementation for 3 days~Pressed Juice: Subjects will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool samples will be collected at baseline, day 4 and day 17."
11226614|NCT02377349|BG000|Baseline|dTpa Group - Mother|This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
11226615|NCT02377349|BG001|Baseline|Control Group - Mother|This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
11226616|NCT02377349|BG002|Baseline|Total|Total of all reporting groups
11226617|NCT02377349|FG000|Participant Flow|dTpa Group - Mother|This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
11226618|NCT02377349|FG001|Participant Flow|Control Group - Mother|This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
11226619|NCT02377349|OG000|Outcome|dTpa Group - Mother|This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
11226620|NCT02377349|OG001|Outcome|Control Group - Mother|This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
11226621|NCT02377349|OG000|Outcome|dTpa Group - Infant|This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.
11226622|NCT02377349|OG001|Outcome|Control Group - Infnat|This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy.
11226623|NCT02377349|OG002|Outcome|dTpa Group - Infant|This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.
11226624|NCT02377349|OG003|Outcome|Control Group - Infant|This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy
11052787|NCT01318278|BG000|Baseline|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
11226625|NCT02377349|OG004|Outcome|Household Group|This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
11052788|NCT01318278|BG001|Baseline|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
11052789|NCT01318278|BG002|Baseline|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
11226626|NCT02377349|OG000|Outcome|Household Group|This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
11226627|NCT02377349|EG000|Reported Event|dTpa Group-Mother|This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
11226628|NCT02377349|EG001|Reported Event|Control Group-Mother|This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
11226629|NCT02377349|EG002|Reported Event|dTpa Group - Infant|This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.
11226630|NCT02377349|EG003|Reported Event|Control Group-Infant|This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy
10847033|NCT00281580|OG015|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
10847034|NCT00281580|OG000|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
11052790|NCT01318278|BG003|Baseline|Total|Total of all reporting groups
11226631|NCT02377349|EG004|Reported Event|Household Group|This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
11226632|NCT02377362|BG000|Baseline|GLWL-01, Part A (Placebo; 150 mg; 600 mg)|"Part A: Cohort 1(C1) Sequence 1 (Placebo, 150 mg, 600 mg)~Placebo was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention"
11226633|NCT02377362|BG001|Baseline|GLWL-01, Part A (10 mg; Placebo; 600 mg)|"Part A: Cohort 1(C1) Sequence 2 (10 mg, Placebo, 600 mg)~10 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention."
11226634|NCT02377362|BG002|Baseline|GLWL-01, Part A (10 mg; 150 mg; Placebo)|"Part A: Cohort 1(C1) Sequence 3 (10 mg, 150 mg, Placebo)~10 mg GLWL 01 was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention"
11226635|NCT02377362|BG003|Baseline|GLWL-01, Part A (Placebo; 300 mg; 1200 mg)|"Part A: Cohort 2(C2) Sequence 1 (Placebo, 300 mg, 1200 mg)~Placebo was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention"
11226636|NCT02377362|BG004|Baseline|GLWL-01 Part A (50 mg, Placebo; 1200 mg)|"Part A: Cohort 2(C2) Sequence 2 (50 mg, Placebo, 1200 mg)~50 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention"
11226637|NCT02377362|BG005|Baseline|GLWL-01, Part A ( 50 mg; 300 mg; Placebo)|"Part A: Cohort 2(C3) Sequence 3 (50 mg, 300 mg, Placebo)~50 mg GLWL 01 was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention"
11226638|NCT02377362|BG006|Baseline|GLWL-01, Part B (50 mg Twice a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226639|NCT02377362|BG007|Baseline|GLWL-01, Part B (150 mg Twice a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226640|NCT02377362|BG008|Baseline|GLWL-01, Part B (300 mg Once a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226641|NCT02377362|BG009|Baseline|GLWL-01, Part B (450 mg Once a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226642|NCT02377362|BG010|Baseline|GLWL-01, Part B (450 mg Twice a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226643|NCT02377362|BG011|Baseline|GLWL-01, Part B (600 mg Twice a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226644|NCT02377362|BG012|Baseline|Placebo, Part B|"Multiple daily doses of placebo to match GLWL-01~Placebo, Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226645|NCT02377362|BG013|Baseline|Total|Total of all reporting groups
11226646|NCT02377362|FG000|Participant Flow|GLWL-01, Part A (Placebo; 150 mg; 600 mg)|"Part A: Cohort 1(C1) Sequence 1 (Placebo, 150 mg, 600 mg)~Placebo was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention."
11226647|NCT02377362|FG001|Participant Flow|GLWL-01, Part A (10 mg; Placebo; 600 mg)|"Part A: Cohort 1(C1) Sequence 2 (10 mg, Placebo, 600 mg)~10 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention."
11226648|NCT02377362|FG002|Participant Flow|GLWL-01, Part A (10 mg; 150 mg; Placebo)|"Part A: Cohort 1(C1) Sequence 3 (10 mg, 150 mg, Placebo)~10 mg GLWL 01 was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention."
11226649|NCT02377362|FG003|Participant Flow|GLWL-01, Part A (Placebo; 300 mg; 1200 mg)|"Part A: Cohort 2(C2) Sequence 1 (Placebo, 300 mg, 1200 mg)~Placebo was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention"
11052791|NCT01318278|FG000|Participant Flow|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
11226650|NCT02377362|FG004|Participant Flow|GLWL-01, Part A (50 mg, Placebo; 1200 mg)|"Part A: Cohort 2(C2) Sequence 2 (50 mg, Placebo, 1200 mg)~50 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention"
11226651|NCT02377362|FG005|Participant Flow|GLWL-01, Part A ( 50 mg; 300 mg; Placebo)|"Part A: Cohort 2(C3) Sequence 3 (50 mg, 300 mg, Placebo)~50 mg GLWL 01 was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention."
11226652|NCT02377362|FG006|Participant Flow|GLWL-01, Part B (50 mg, Twice a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226653|NCT02377362|FG007|Participant Flow|GLWL-01, Part B (150 mg Twice a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226654|NCT02377362|FG008|Participant Flow|GLWL-01, Part B (300 mg Once a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226655|NCT02377362|FG009|Participant Flow|GLWL-01, Part B (450 mg Once a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11052792|NCT01318278|FG001|Participant Flow|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
11226656|NCT02377362|FG010|Participant Flow|GLWL-01, Part B, (450 mg Twice a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11052793|NCT01318278|FG002|Participant Flow|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
11052794|NCT01318278|OG000|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
11052795|NCT01318278|OG001|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
11052796|NCT01318278|OG002|Outcome|Comparison Group|Infants not diagnosed with hypotension in first 24 hours
11052797|NCT01318278|OG002|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
11052798|NCT01318278|EG000|Reported Event|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
11052799|NCT01318278|EG001|Reported Event|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
11052800|NCT01318278|EG002|Reported Event|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
11052801|NCT01318356|BG000|Baseline|Cognitive Behavioral Therapy|Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).
11052802|NCT01318356|BG001|Baseline|Doxycycline|Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.
11052803|NCT01318356|BG002|Baseline|Placebo|Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
11052804|NCT01318356|BG003|Baseline|Total|Total of all reporting groups
11052805|NCT01318356|FG000|Participant Flow|Cognitive Behavioral Therapy|Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).
11226657|NCT02377362|FG011|Participant Flow|GLWL-01, Part B (600 mg Twice a Day)|"Multiple oral doses~Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11226658|NCT02377362|FG012|Participant Flow|Placebo, Part B|"Multiple oral doses of placebo to match GLWL-01~Placebo, Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28"
11052806|NCT01318356|FG001|Participant Flow|Doxycycline|Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.
11052807|NCT01318356|FG002|Participant Flow|Placebo|Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
11052808|NCT01318356|OG000|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).
11052809|NCT01318356|OG001|Outcome|Doxycycline|Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.
11052810|NCT01318356|OG002|Outcome|Placebo|Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
11052811|NCT01318356|EG000|Reported Event|Cognitive Behavioral Therapy|Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).
11052812|NCT01318356|EG001|Reported Event|Doxycycline|Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.
11052813|NCT01318356|EG002|Reported Event|Placebo|Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
11226659|NCT02377362|OG000|Outcome|GLWL-01 Part A (10mg)|10 milligrams (mg)
11226660|NCT02377362|OG001|Outcome|GLWL-01 Part A (50 mg)|50 mg
11226661|NCT02377362|OG002|Outcome|GLWL-01 Part A (150 mg)|150 mg
11226662|NCT02377362|OG003|Outcome|GLWL-01 Part A (300 mg)|300 mg
11226663|NCT02377362|OG004|Outcome|GLWL-01 Part A (600 mg)|600 mg
11052814|NCT01318382|BG000|Baseline|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
11052815|NCT01318382|FG000|Participant Flow|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from neuromuscular blockade (NMB) monitored by a TOF-Watch SX®.
11052816|NCT01318382|OG000|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
11052817|NCT01318382|OG000|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
11052818|NCT01318382|EG000|Reported Event|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
11052819|NCT01318408|BG000|Baseline|Open Label|All participants received study drug.
11052820|NCT01318408|FG000|Participant Flow|Open Label|All participants received study drug.
11052821|NCT01318408|OG000|Outcome|Open Label|All participants received study drug.
11052822|NCT01318408|EG000|Reported Event|Open Label|All participants received study drug. Four withdrew due to adverse events; related to fatigue.
11226664|NCT02377362|OG005|Outcome|GLWL-01 Part A Placebo|
11052823|NCT01318499|BG000|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052824|NCT01318499|BG001|Baseline|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052825|NCT01318499|BG002|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052826|NCT01318499|BG003|Baseline|Total|Total of all reporting groups
11052827|NCT01318499|FG000|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052828|NCT01318499|FG001|Participant Flow|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052829|NCT01318499|FG002|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052830|NCT01318499|OG000|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052831|NCT01318499|OG001|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052832|NCT01318499|OG001|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052833|NCT01318499|OG002|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052834|NCT01318499|OG002|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052835|NCT01318499|EG000|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052836|NCT01318499|EG001|Reported Event|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052837|NCT01318499|EG002|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
11052838|NCT01318512|BG000|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
11226665|NCT02377362|OG000|Outcome|GLWL-01 Part B (50 mg, Twice a Day)|
11052839|NCT01318512|FG000|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
11052840|NCT01318512|OG000|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
11052841|NCT01318512|OG000|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of haemoglobin.
11052842|NCT01318512|OG000|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
11052843|NCT01318512|EG000|Reported Event|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
11052844|NCT01318538|BG000|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
11052845|NCT01318538|BG001|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. NOTE: Baseline characteristics reported in Table Below reflect all participants including men assigned to the GDC condition. Analysis of data for study specific aims include only women randomized to WRG (N=52) and GDC (N=48).
11052846|NCT01318538|BG002|Baseline|Total|Total of all reporting groups
11052847|NCT01318538|FG000|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
11052848|NCT01318538|FG001|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
11052849|NCT01318538|FG002|Participant Flow|Group Therapist|Therapists who ran and led the group sessions for both the single-gender Women's Recovery Group and mixed-gender Group Drug Counseling.
11052850|NCT01318538|OG000|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
11052851|NCT01318538|OG001|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
11226666|NCT02377362|OG001|Outcome|GLWL-01 Part B (150 mg, Twice a Day)|
11226667|NCT02377362|OG002|Outcome|GLWL-01 Part B (300 mg, Once a Day)|
11226668|NCT02377362|OG003|Outcome|GLWL-01 Part B (450 mg, Once a Day)|
11226669|NCT02377362|OG004|Outcome|GLWL-01 Part B (450 mg, Twice a Day)|
11226670|NCT02377362|OG005|Outcome|GLWL-01 Part B (600 mg, Twice a Day)|
11226671|NCT02377362|OG006|Outcome|GLWL-01 Part B Placebo|
11226672|NCT02377362|OG000|Outcome|GLWL-01 Part B (50mg, Twice a Day)|50 milligrams (mg), twice a day (BID)
10847035|NCT00281580|OG001|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
11052852|NCT01318538|OG000|Outcome|Women's Recovery Group|Participants in this analysis are the therapists that lead the WRG groups. The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
11052853|NCT01318538|OG001|Outcome|Mixed-gender Group Drug Counseling|Participants in this analysis are the therapists that lead GDC groups. Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
11052854|NCT01318538|EG000|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
11052855|NCT01318538|EG001|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance dependence; 3) increase patients' self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
11052856|NCT01318577|BG000|Baseline|Investigational Solution|"Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.~Investigational Cleaning & Disinfecting Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution"
11052857|NCT01318577|BG001|Baseline|Clear Care Solution|"Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses~Clear Care Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution"
11052858|NCT01318577|BG002|Baseline|Total|Total of all reporting groups
11052859|NCT01318577|FG000|Participant Flow|Investigational Solution|"Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.~Investigational Cleaning & Disinfecting Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution"
11052860|NCT01318577|FG001|Participant Flow|Clear Care Solution|"Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses~Clear Care Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution"
11052861|NCT01318577|OG000|Outcome|Investigational Solution|"Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.~Investigational Cleaning & Disinfecting Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution"
11052862|NCT01318577|OG001|Outcome|Clear Care Solution|"Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses~Clear Care Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution"
11052863|NCT01318577|EG000|Reported Event|Investigational Solution|"Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.~Investigational Cleaning & Disinfecting Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution"
11052864|NCT01318577|EG001|Reported Event|Clear Care Solution|"Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses~Clear Care Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution"
11052865|NCT01318694|BG000|Baseline|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
11052866|NCT01318694|BG001|Baseline|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
11226673|NCT02377362|OG001|Outcome|GLWL-01 Part B (150 mg, Twice a Day)|150 mg, twice a day (BID)
10847036|NCT00281580|OG002|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
11052867|NCT01318694|BG002|Baseline|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
11052868|NCT01318694|BG003|Baseline|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
11052869|NCT01318694|BG004|Baseline|Total|Total of all reporting groups
11052870|NCT01318694|FG000|Participant Flow|Treatment Arm A|Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT)
11052871|NCT01318694|FG001|Participant Flow|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
11052872|NCT01318694|FG002|Participant Flow|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
11052873|NCT01318694|FG003|Participant Flow|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
11226674|NCT02377362|OG002|Outcome|GLWL-01 Part B (300 mg, Once a Day)|300 mg, once a day (QD)
11052874|NCT01318694|OG000|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
11052875|NCT01318694|OG001|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
11052876|NCT01318694|OG002|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
11052877|NCT01318694|OG003|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
11052878|NCT01318694|EG000|Reported Event|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
11052879|NCT01318694|EG001|Reported Event|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
11052880|NCT01318694|EG002|Reported Event|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
11052881|NCT01318694|EG003|Reported Event|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
11226675|NCT02377362|OG003|Outcome|GLWL-01 Part B (450 mg, Once a Day)|450 mg once a day (QD)
11226676|NCT02377362|OG004|Outcome|GLWL-01 Part B (450 mg, Twice a Day)|450 mg twice a day (BID)
11052882|NCT01318733|BG000|Baseline|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
11052883|NCT01318733|FG000|Participant Flow|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
11052884|NCT01318733|OG000|Outcome|CD07805/47 Gel 0.5% QD|
11052885|NCT01318733|EG000|Reported Event|CD07805/47 Gel 0.5%|
11052886|NCT01318811|BG000|Baseline|Dilute Heparin|"Arm A will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter.~Dilute unfractionated heparin: Patients in the dilute heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started. Heparin will be delivered as a solution of 2 units/mL and the infusion will be prepared with 2,000 units of heparin in 1,000 mL of 0.9% NaCl and delivered intravenously proximal to the dialysis filter."
11052887|NCT01318811|BG001|Baseline|Standard Concentrated Heparin|"Arm B will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter.~Standard concentration unfractionated heparin: Patients in the standard heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started and delivered in a standard concentration intravenously proximal to the dialysis filter via a syringe. The concentration of heparin used will be 1,000 units of heparin per 1 mL of 0.9% NaCl."
11052888|NCT01318811|BG002|Baseline|Total|Total of all reporting groups
11052889|NCT01318811|FG000|Participant Flow|Dilute Heparin|"Arm B will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter.~Dilute unfractionated heparin: Patients in the dilute heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started. Heparin will be delivered as a solution of 2 units/mL and the infusion will be prepared with 2,000 units of heparin in 1,000 mL of 0.9% NaCl and delivered intravenously proximal to the dialysis filter."
11052890|NCT01318811|FG001|Participant Flow|Standard Concentrated Heparin|"Arm A will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter.~Standard concentration unfractionated heparin: Patients in the standard heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started and delivered in a standard concentration intravenously proximal to the dialysis filter via a syringe. The concentration of heparin used will be 1,000 units of heparin per 1 mL of 0.9% NaCl."
11052891|NCT01318811|OG000|Outcome|Dilute Heparin|"Arm A will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter.~Dilute unfractionated heparin: Patients in the dilute heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started. Heparin will be delivered as a solution of 2 units/mL and the infusion will be prepared with 2,000 units of heparin in 1,000 mL of 0.9% NaCl and delivered intravenously proximal to the dialysis filter."
11052892|NCT01318811|OG001|Outcome|Standard Concentrated Heparin|"Arm B will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter.~Standard concentration unfractionated heparin: Patients in the standard heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started and delivered in a standard concentration intravenously proximal to the dialysis filter via a syringe. The concentration of heparin used will be 1,000 units of heparin per 1 mL of 0.9% NaCl."
11052893|NCT01318811|EG000|Reported Event|Dilute Heparin|"Arm A will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter.~Dilute unfractionated heparin: Patients in the dilute heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started. Heparin will be delivered as a solution of 2 units/mL and the infusion will be prepared with 2,000 units of heparin in 1,000 mL of 0.9% NaCl and delivered intravenously proximal to the dialysis filter."
11052894|NCT01318811|EG001|Reported Event|Standard Concentrated Heparin|"Arm B will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter.~Standard concentration unfractionated heparin: Patients in the standard heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started and delivered in a standard concentration intravenously proximal to the dialysis filter via a syringe. The concentration of heparin used will be 1,000 units of heparin per 1 mL of 0.9% NaCl."
11052895|NCT01318876|BG000|Baseline|Health Care Workers|HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study.
11052896|NCT01318876|FG000|Participant Flow|Health Care Workers|
11052897|NCT01318876|OG000|Outcome|HCW From All Sites|
11052898|NCT01318876|EG000|Reported Event|HCW From All Sites|
11226677|NCT02377362|OG005|Outcome|GLWL-01 Part B (600 mg, Twice a Day)|600 mg, twice a day (BID)
11052899|NCT01318902|BG000|Baseline|Dose Escalation Cohort: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
11052900|NCT01318902|BG001|Baseline|Dose Escalation Cohort: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
11052901|NCT01318902|BG002|Baseline|Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)|Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052902|NCT01318902|BG003|Baseline|Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)|Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052903|NCT01318902|BG004|Baseline|Total|Total of all reporting groups
11052904|NCT01318902|FG000|Participant Flow|Dose Escalation Cohort: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
11052905|NCT01318902|FG001|Participant Flow|Dose Escalation Cohort: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
11052906|NCT01318902|FG002|Participant Flow|Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)|Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052907|NCT01318902|FG003|Participant Flow|Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)|Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052908|NCT01318902|OG000|Outcome|Dose Escalation Cohort: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
11052909|NCT01318902|OG001|Outcome|Dose Escalation Cohort: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
11052910|NCT01318902|OG002|Outcome|Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)|Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052911|NCT01318902|OG003|Outcome|Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)|Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052912|NCT01318902|OG000|Outcome|Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1 and 15 during each 28-day treatment cycle for all the participants from dose escalation and expansion cohorts were evaluated in this arm group. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052913|NCT01318902|OG001|Outcome|Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone was added on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. The maximum duration of treatment was up to 12 cycles.
11052914|NCT01318902|EG000|Reported Event|Dose Escalation Cohort: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
11226678|NCT02377362|OG004|Outcome|GLWL-01, Part B (450 mg Twice a Day)|450 mg twice a day (BID)
11226679|NCT02377362|OG006|Outcome|Placebo Part B|
11052915|NCT01318902|EG001|Reported Event|Dose Escalation Cohort: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
11052916|NCT01318902|EG002|Reported Event|Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)|Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052917|NCT01318902|EG003|Reported Event|Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)|Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
11052918|NCT01318915|BG000|Baseline|Induction (Rituximab and ATG)|Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
11052919|NCT01318915|FG000|Participant Flow|Induction (Rituximab and ATG)|Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
11052920|NCT01318915|OG000|Outcome|Induction (Rituximab and ATG)|Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
10847037|NCT00281580|OG003|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
11149257|NCT01869777|OG000|Outcome|Diagnostic (Bioelectric Impedance Analysis)|"Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement just prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, PICC line placement, etc.).~bioelectric impedance analysis: Undergo bioelectric impedance analysis"
11149258|NCT01869777|EG000|Reported Event|Diagnostic (Bioelectric Impedance Analysis)|"Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement just prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, PICC line placement, etc.).~bioelectric impedance analysis: Undergo bioelectric impedance analysis"
11149259|NCT01869959|BG000|Baseline|3 mg LY2405319|3 mg LY2405319 injected SC once daily for 28 days.
11149260|NCT01869959|BG001|Baseline|10 mg LY2405319|10 mg LY2405319 injected SC once daily for 28 days.
11149261|NCT01869959|BG002|Baseline|20 mg LY2405319|20 mg LY2405319 injected SC once daily for 28 days.
11149262|NCT01869959|BG003|Baseline|Placebo|Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
11149263|NCT01869959|BG004|Baseline|Total|Total of all reporting groups
11149264|NCT01869959|FG000|Participant Flow|3 mg LY2405319|3 milligrams (mg) LY2405319 injected SC once daily for 28 days.
11149265|NCT01869959|FG001|Participant Flow|10 mg LY2405319|10 mg LY2405319 injected SC once daily for 28 days.
11149266|NCT01869959|FG002|Participant Flow|20 mg LY2405319|20 mg LY2405319 injected SC once daily for 28 days.
11149267|NCT01869959|FG003|Participant Flow|Placebo|Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
11149268|NCT01869959|FG004|Participant Flow|All Randomized Participants|All participants randomized in the study.
11149269|NCT01869959|OG000|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
11149270|NCT01869959|OG001|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
11149271|NCT01869959|OG002|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
11149272|NCT01869959|OG003|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
11149273|NCT01869959|EG000|Reported Event|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
11052921|NCT01318915|OG000|Outcome|Transplanted|Adult living donor kidney transplant recipients that were enrolled into the study prior to transplant and met all criteria for study participation. These participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 prior to transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on the anti-rejection medications tacrolimus, MMF, and sirolimus after transplant. Participants were evaluated for eligibility to start gradual withdrawal of their anti-rejection medications starting as early as 26 weeks post-transplant. Eligible participants were gradually withdrawn from anti-rejection medication over a period of 68-104 weeks.
11052922|NCT01318915|OG000|Outcome|Induction (Rituximab and ATG)|Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
11052923|NCT01318915|EG000|Reported Event|Transplanted|These are adult living donor kidney transplant recipients that were enrolled into the study prior to transplant and met all criteria for study participation. These participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m2. The first dose of rituximab was given around day -6 prior to transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on the anti-rejection medications tacrolimus, MMF, and sirolimus after transplant. Participants were evaluated for eligibility to start gradual withdrawal of their anti-rejection medications starting as early as 26 weeks post-transplant. Eligible participants were gradually withdrawn from anti-rejection medication over a period of 68-104 weeks.
11052924|NCT01318967|BG000|Baseline|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
11052925|NCT01318967|FG000|Participant Flow|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
11052926|NCT01318967|OG000|Outcome|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.~Renal blood flow is measured by PAH method and by MRI method"
11052927|NCT01318967|OG000|Outcome|MRI After Furosemide|"After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow~Furosemide: Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only."
11052928|NCT01318967|EG000|Reported Event|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
11052929|NCT01319045|BG000|Baseline|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
11052930|NCT01319045|FG000|Participant Flow|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
11052931|NCT01319045|OG000|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
11052932|NCT01319045|EG000|Reported Event|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
11052933|NCT01319110|BG000|Baseline|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
11052934|NCT01319110|BG001|Baseline|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
11052935|NCT01319110|BG002|Baseline|Total|Total of all reporting groups
11052936|NCT01319110|FG000|Participant Flow|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
11052937|NCT01319110|FG001|Participant Flow|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
11226680|NCT02377362|OG004|Outcome|GLWL-01, Part B (450 mg, Twice a Day)|450 mg, twice a day (BID)
11226681|NCT02377362|OG004|Outcome|GLWL-01 Part B (450 mg, Twice a Day)|450 mg, twice a day (BID)
11226682|NCT02377362|EG000|Reported Event|GLWL-01, Part A (10mg)|10 milligrams (mg)
11052938|NCT01319110|OG000|Outcome|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
11052939|NCT01319110|OG001|Outcome|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
11052940|NCT01319110|EG000|Reported Event|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
11052941|NCT01319110|EG001|Reported Event|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
11052942|NCT01319318|BG000|Baseline|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
11052943|NCT01319318|FG000|Participant Flow|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
11052944|NCT01319318|OG000|Outcome|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
11052945|NCT01319318|EG000|Reported Event|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
11052946|NCT01319383|BG000|Baseline|Single, Multiple and Interval Dosing Of Vorinostat 400 mg PO|The study was separated into Arms for reporting purposes required in this report. The data representing the eligibility and baseline measures were the same throughout the study and are therefore reported as a composite of the entire study. Vorinostat 400 mg PO was administered in single and multiple doses in both Arm 1 and 2. The entire cohort is described below and representative of all who were enrolled in the study over the 5 year period.
11052947|NCT01319383|FG000|Participant Flow|Single and Multiple Dose|There are 3 Steps in this Arm: Step 1 a Baseline leukapheresis was completed to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL); ex-vivo exposure. Step 2 measured the in-vivo response to single dose of VOR; Step 3 measured the in vivo response after each of 2 series of exposure to multiple doses of VOR 400 mg PO. In each series, 11 doses of VOR were administered for 3 days (M-T-W) and no doses for the remaining 4 days. A leukapheresis was completed 4 hours after the 11th dose to measure in vivo response.
11052948|NCT01319383|FG001|Participant Flow|Interval Dosing|There are 4 steps in this Arm. Step 1 Baseline leukapheresis (Visit 2) to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL). Ex-vivo exposure to measure RCVL responsiveness to Vorinostat. Step 2 involved measurement of in vivo response to single dose of VOR. Step 3 involved 2 doses separated by 48 or 72 hours. In vivo responsiveness measured for optimal dose interval and step advancement. Step 4 measured significance of response to VOR 400 mg PO taken every 72 hours for 10 doses.
11052949|NCT01319383|OG000|Outcome|1/Single & Multiple Dose, Step 2, Visit 5|Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
11052950|NCT01319383|OG001|Outcome|2/Interval Dosing, Visit 3|Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
11052951|NCT01319383|OG000|Outcome|Arm 1 - Single and Multiple Dose, Step 3|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR doses were eligible to receive multiple doses of VOR 400 mg. The first dose was administered in clinic with observation for symptoms for 1 hour post dose. Symptoms were assessed daily and on the third day 4 hours after the dose. These participants took VOR 400 mg (PO) in the AM for 3 days each week (dose every M-T-W) for 3 weeks. On the 4th week, the participant took 2 doses of VOR 400 mg (M-T) in the AM. A leukapheresis was completed 4 hours after the 2nd dose of VOR to measure RCVL in-vivo response. After a 4 - 8 week rest period, participants without dose-limiting symptoms repeated the 4 week cycle.
11052952|NCT01319383|OG000|Outcome|Interval Dosing , Step 3 (48 hr Interval)|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR dose were eligible to receive 2 doses of VOR 400 mg PO, given at the pre-determined interval of 48 hours. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms. Leukapheresis procedure performed 4 hours after the 2nd dose to measure RCVL in-vivo response.
11052953|NCT01319383|OG001|Outcome|Interval Dosing, Step 3 (72 Hour Interval)|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR dose were eligible to receive 2 doses of VOR 400 mg PO, given at the pre-determined interval of 72 hours. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms. Leukapheresis procedure performed 4 hours after the 2nd dose to measure RCVL in-vivo response.
11149274|NCT01869959|EG001|Reported Event|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
11149275|NCT01869959|EG002|Reported Event|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
11149276|NCT01869959|EG003|Reported Event|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
11149277|NCT01870076|BG000|Baseline|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
11149278|NCT01870076|BG001|Baseline|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
11052954|NCT01319383|OG000|Outcome|Interval Doses (Multiple) Step 4|"Participants without dose-limiting symptoms and exhibiting an in vivo response to the paired doses of VOR 400 mg PO were eligible to receive 10 doses of VOR, given at the pre-determined interval. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms and clinical assessments at after the 3rd, 5th, 8th and 10th doses. Participant were only given the required doses for administration between visits.~Leukapheresis procedure performed 4 hours after the 10th dose to measure RCVL in-vivo response."
11052955|NCT01319383|OG000|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Group Arm who received at least one dose of VOR 400 mg PO
11052956|NCT01319383|OG001|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO
11052957|NCT01319383|OG000|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Group Arm who received at least one dose of VOR 400 mg PO.
11052958|NCT01319383|OG001|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO.
11052959|NCT01319383|OG000|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Arm who received at least one dose of VOR 400 mg PO.
11052960|NCT01319383|OG001|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO..
11052961|NCT01319383|OG000|Outcome|1/Single and Multiple Dose, Step 3|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR doses were eligible to receive multiple doses of VOR 400 mg. The first dose was administered in clinic with observation for symptoms for 1 hour post dose. Symptoms were assessed daily and on the third day 4 hours after the dose. These participants took VOR 400 mg (PO) in the AM for 3 days each week (dose every M-T-W) for 3 weeks. On the 4th week, the participant took 2 doses of VOR 400 mg (M-T) in the AM. A leukapheresis was completed 4 hours after the 2nd dose of VOR to measure RCVL in-vivo response. After a 4 - 8 week rest period, participants without dose-limiting symptoms repeated the 4 week cycle.
11052962|NCT01319383|OG001|Outcome|2/Interval Doses (Multiple) Step 4|"Participants without dose-limiting symptoms and exhibiting an in vivo response to the paired dose of VOR dose were eligible to receive 10 doses of VOR 400 mg PO, given at the pre-determined interval. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms and clinical assessments at after the 3rd, 5th, 8th and 10th doses. Participant were only given the required doses for administration between visits.~Leukapheresis procedure performed 4 hours after the 10th dose to measure RCVL in-vivo response."
11052963|NCT01319383|EG000|Reported Event|Open Label - Translational Research Study|"Period One: Step 1 (ex-vivo), Step 2 (single dose) and Step 3 (multiple dose). Advancement to each step required demonstration of significant HIV-1 RNA expression per 1 million RCVL response to VOR. Step 1: All participants had an ex-vivo exposure to VOR. Step 2: Participants with and without an ex-vivo response received 1 single dose VOR. Step 3: Participants demonstrating an in vivo response received multiple doses consisting of 2 series of 11 VOR doses each; with in vivo response measured after each series. Period One was stopped due to lack of significant in-vivo response to the multiple doses.~Period Two: Step 1, Step 2 and advancement criteria are the same as above. Step 3 (interval paired dose) and Step 4 (multiple interval doses). Participants without an ex-vivo response did not progress past Step 1. Step 3: Responders received 2 doses separated by 48 or 72 hours. Step 4: Responders then received 10 doses of VOR at pre-determined interval."
11052964|NCT01319396|BG000|Baseline|5.8 GHz Sensor Spot Respiration Rate|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 5GHz non-contact sensor (device under test) and the Somnoscreen (reference device using chest effort bands)
11052965|NCT01319396|FG000|Participant Flow|5GHz Sensor Spot Respiration Rate|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 5GHz non-contact sensor (device under test) and the Somnoscreen (reference device using chest effort bands)
11052966|NCT01319396|OG000|Outcome|5GHz Sensor Spot Respiration Rate|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 5GHz non-contact sensor (device under test) and the Somnoscreen (reference device using chest effort bands)
11052967|NCT01319396|EG000|Reported Event|5.8 GHz Sensor Spot Respiration Rate|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 5GHz non-contact sensor (device under test) and the Somnoscreen (reference device using chest effort bands)
11052968|NCT01319422|BG000|Baseline|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
11052969|NCT01319422|BG001|Baseline|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
11052970|NCT01319422|BG002|Baseline|Total|Total of all reporting groups
11052971|NCT01319422|FG000|Participant Flow|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
11052972|NCT01319422|FG001|Participant Flow|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
11052973|NCT01319422|OG000|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
11052974|NCT01319422|OG001|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
11052975|NCT01319422|EG000|Reported Event|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
11052976|NCT01319422|EG001|Reported Event|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
11052977|NCT01319500|BG000|Baseline|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
11052978|NCT01319500|BG001|Baseline|Other OCs|"Users of OCs except Yasmin (Other OCs)"
11052979|NCT01319500|BG002|Baseline|Total|Total of all reporting groups
11052980|NCT01319500|FG000|Participant Flow|Yasmin|"Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC Yasmin"
11052981|NCT01319500|FG001|Participant Flow|Other OCs|"Users of oral contraceptives (OCs) except Yasmin (Other OCs)"
11052982|NCT01319500|OG000|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
11052983|NCT01319500|OG001|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
11052984|NCT01319500|OG000|Outcome|Gynecologists (All)|All gynecologists (private and public)
11052985|NCT01319500|OG001|Outcome|Gynecologists (Private Practice Only)|Gynecologists in private practice only
11052986|NCT01319500|OG002|Outcome|Gynecologists (Public Practice Only)|Gynecologists in public practice only
11052987|NCT01319500|OG003|Outcome|Dermatologists|All dermatologists
11052988|NCT01319500|OG004|Outcome|Total|All gynecologists (private and public) and dermatologists
11052989|NCT01319500|EG000|Reported Event|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
11052990|NCT01319500|EG001|Reported Event|Other OCs|"Users of OCs except Yasmin (Other OCs)"
11052991|NCT01319539|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.~Akt Inhibitor MK2206: Given PO~Therapeutic Conventional Surgery: Undergo surgery~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies"
11052992|NCT01319539|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.~Akt Inhibitor MK2206: Given PO~Therapeutic Conventional Surgery: Undergo surgery~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies"
11052993|NCT01319539|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.~Akt Inhibitor MK2206: Given PO~Therapeutic Conventional Surgery: Undergo surgery~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies"
11052994|NCT01319539|EG000|Reported Event|Treatment (MK2206) Dose Level 200mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
11052995|NCT01319539|EG001|Reported Event|Treatment (MK2206) Dose Level 135mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
11052996|NCT01319539|EG002|Reported Event|Treatment (MK2206) Dose Level 90mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
11052997|NCT01319552|BG000|Baseline|Transfusion|"Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions~1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Old transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions"
11052998|NCT01319552|FG000|Participant Flow|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
11052999|NCT01319552|OG000|Outcome|Fresh Transfusion|Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
11053000|NCT01319552|OG001|Outcome|Old Transfusion|Old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
11053001|NCT01319552|EG000|Reported Event|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
11053002|NCT01319617|BG000|Baseline|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
11053003|NCT01319617|FG000|Participant Flow|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center."
11053004|NCT01319617|OG000|Outcome|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
11053005|NCT01319617|EG000|Reported Event|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
11053006|NCT01319721|BG000|Baseline|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
11053007|NCT01319721|BG001|Baseline|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
11053008|NCT01319721|BG002|Baseline|Total|Total of all reporting groups
11053009|NCT01319721|FG000|Participant Flow|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
11053010|NCT01319721|FG001|Participant Flow|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
11053011|NCT01319721|OG000|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
11053012|NCT01319721|OG001|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
11053013|NCT01319721|EG000|Reported Event|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
11053014|NCT01319721|EG001|Reported Event|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
11053015|NCT01319773|BG000|Baseline|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
11053016|NCT01319773|BG001|Baseline|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
11053017|NCT01319773|BG002|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
11053018|NCT01319773|BG003|Baseline|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
11053019|NCT01319773|BG004|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
11053020|NCT01319773|BG005|Baseline|Total|Total of all reporting groups
11053021|NCT01319773|FG000|Participant Flow|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
11053022|NCT01319773|FG001|Participant Flow|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
11053023|NCT01319773|FG002|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
11053024|NCT01319773|FG003|Participant Flow|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
11053025|NCT01319773|FG004|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
11053026|NCT01319773|OG000|Outcome|Cyclosporine Formulation A|
10847038|NCT00281580|OG004|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
11053027|NCT01319773|OG001|Outcome|Cyclosporine Formulation B|
11053028|NCT01319773|OG002|Outcome|Cyclosporine 0.05%|
11053029|NCT01319773|EG000|Reported Event|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
11053030|NCT01319773|EG001|Reported Event|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
11053031|NCT01319773|EG002|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
11053032|NCT01319773|EG003|Reported Event|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
11053033|NCT01319773|EG004|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
11066771|NCT01393964|OG002|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
11066772|NCT01393964|OG000|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
11149279|NCT01870076|BG002|Baseline|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
11149280|NCT01870076|BG003|Baseline|Control, No Presence|No Presence in the room one hour prior to bed.
11149281|NCT01870076|BG004|Baseline|Total|Total of all reporting groups
11149282|NCT01870076|FG000|Participant Flow|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
11149283|NCT01870076|FG001|Participant Flow|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
10847039|NCT00281580|OG005|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
10847040|NCT00281580|OG006|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
11149284|NCT01870076|FG002|Participant Flow|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
11053034|NCT01319799|BG000|Baseline|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
11053035|NCT01319799|FG000|Participant Flow|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
11053036|NCT01319799|OG000|Outcome|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
11053037|NCT01319799|EG000|Reported Event|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
11053038|NCT01319812|BG000|Baseline|Astron Stent Group|Subjects implanted with an Astron stent.
11053039|NCT01319812|BG001|Baseline|Pulsar Stent Group|Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
11053040|NCT01319812|BG002|Baseline|Total|Total of all reporting groups
11053041|NCT01319812|FG000|Participant Flow|Astron Stent Group|Subjects implanted with an Astron stent.
11053042|NCT01319812|FG001|Participant Flow|Pulsar Stent Group|Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
11053043|NCT01319812|OG000|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
11226683|NCT02377362|EG001|Reported Event|GLWL-01 Part A (50 mg)|50 mg
11226684|NCT02377362|EG002|Reported Event|GLWL-01 Part A (150 mg)|150 mg
11053044|NCT01319812|OG000|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
11053045|NCT01319812|OG001|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
11053046|NCT01319812|OG000|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
11053047|NCT01319812|OG001|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
11053048|NCT01319812|OG002|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
11053049|NCT01319812|OG003|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
11053050|NCT01319812|OG000|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
11053051|NCT01319812|OG001|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
11053052|NCT01319812|EG000|Reported Event|Astron Stent Group|Subjects indicated for stenting in iliac atherosclerotic lesions.
11053053|NCT01319812|EG001|Reported Event|Pulsar Stent Group|Subjects indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
11053054|NCT01319851|BG000|Baseline|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
11053055|NCT01319851|FG000|Participant Flow|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
11053056|NCT01319851|OG000|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
11053057|NCT01319851|EG000|Reported Event|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
11053058|NCT01319877|BG000|Baseline|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
11053059|NCT01319877|BG001|Baseline|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
11053060|NCT01319877|BG002|Baseline|Total|Total of all reporting groups
11053061|NCT01319877|FG000|Participant Flow|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
11053062|NCT01319877|FG001|Participant Flow|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
11053063|NCT01319877|OG000|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
11053064|NCT01319877|OG001|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
11053065|NCT01319877|EG000|Reported Event|First and Second Line Treatment|The participants from the first line and second line treatments were combined for the adverse event analysis.
11053066|NCT01319929|BG000|Baseline|80 mg LY2828360 First, Then Placebo|Participants received 80 milligrams (mg) of LY2828360 once daily by mouth for 4 weeks, followed by a 3-week washout period, then placebo once daily by mouth for 4 weeks.
11053067|NCT01319929|BG001|Baseline|Placebo First, Then 80 mg LY2828360|Participants received placebo once daily by mouth for 4 weeks, followed by a 3-week washout period, then 80 mg of LY2828360 once daily by mouth for 4 weeks.
11053068|NCT01319929|BG002|Baseline|Total|Total of all reporting groups
11053069|NCT01319929|FG000|Participant Flow|80 mg LY2828360 First, Then Placebo|Participants received 80 milligrams (mg) of LY2828360 once daily by mouth for 4 weeks, followed by a 3-week washout period, then placebo once daily by mouth for 4 weeks.
11226685|NCT02377362|EG003|Reported Event|GLWL-01 Part A (300 mg)|300 mg
11226686|NCT02377362|EG004|Reported Event|GLWL-01 Part A (600 mg)|600 mg
11226687|NCT02377362|EG005|Reported Event|GLWL-01 Part A Placebo|
11226688|NCT02377362|EG006|Reported Event|GLWL-01 Part B (50 mg, Twice a Day)|
11053070|NCT01319929|FG001|Participant Flow|Placebo First, Then 80 mg LY2828360|Participants received placebo once daily by mouth for 4 weeks, followed by a 3-week washout period, then 80 mg of LY2828360 once daily by mouth for 4 weeks.
11053071|NCT01319929|OG000|Outcome|80 mg LY2828360|Participants received 80 milligrams (mg) of LY2828360 once daily by mouth for 4 weeks.
11053072|NCT01319929|OG001|Outcome|Placebo|Participants received placebo once daily by mouth for 4 weeks.
11053073|NCT01319929|OG000|Outcome|80 mg LY2828360|The analysis included all randomized participants received 80 milligrams (mg) of LY2828360 once daily by mouth for 4 weeks.
11053074|NCT01319929|EG000|Reported Event|80 mg LY2828360|Participants received 80 milligrams (mg) of LY2828360 once daily by mouth for 4 weeks.
11053075|NCT01319929|EG001|Reported Event|Placebo|Participants received placebo once daily by mouth for 4 weeks.
11053076|NCT01319994|BG000|Baseline|Metformin|Metformin 850mg TDS
11053077|NCT01319994|BG001|Baseline|Placebo|Placebo 850mg TDS
11053078|NCT01319994|BG002|Baseline|Total|Total of all reporting groups
11053079|NCT01319994|FG000|Participant Flow|Metformin|Metformin 850mg TDS for 12 weeks
11053080|NCT01319994|FG001|Participant Flow|Placebo|Placebo 850mg TDS for 12 weeks
11053081|NCT01319994|OG000|Outcome|Metformin|Metformin 850mg TDS
11053082|NCT01319994|OG001|Outcome|Placebo|Placebo 850mg TDS
11053083|NCT01319994|EG000|Reported Event|Metformin|Metformin 850mg TDS for 12 weeks
11053084|NCT01319994|EG001|Reported Event|Placebo|Placebo 850mg TDS for 12 weeks
11053085|NCT01320033|BG000|Baseline|CD2475/101 40 mg|Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
11053086|NCT01320033|BG001|Baseline|Doxycycline 100 mg|Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
11053087|NCT01320033|BG002|Baseline|Placebo|Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
11053088|NCT01320033|BG003|Baseline|Total|Total of all reporting groups
11053089|NCT01320033|FG000|Participant Flow|CD2475/101 40 mg|Participants received 40 milligrams (mg) of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
11053090|NCT01320033|FG001|Participant Flow|Doxycycline 100 mg|Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
11053091|NCT01320033|FG002|Participant Flow|Placebo|Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
11053092|NCT01320033|OG000|Outcome|CD2475/101 40 mg|Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
11053093|NCT01320033|OG001|Outcome|Doxycycline 100 mg|Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
11053094|NCT01320033|OG002|Outcome|Placebo|Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
11053095|NCT01320033|EG000|Reported Event|CD2475/101 40 mg|Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
11053096|NCT01320033|EG001|Reported Event|Doxycycline 100 mg|Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
11053097|NCT01320033|EG002|Reported Event|Placebo|Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
11053098|NCT01320085|BG000|Baseline|Binimetinib 45 mg BRAF|Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053099|NCT01320085|BG001|Baseline|Binimetinib 45 mg NRAS|Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053100|NCT01320085|BG002|Baseline|Binimetinib 60 mg BRAF|Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053101|NCT01320085|BG003|Baseline|Total|Total of all reporting groups
11053102|NCT01320085|FG000|Participant Flow|Binimetinib 45 mg BRAF|Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053103|NCT01320085|FG001|Participant Flow|Binimetinib 45 mg NRAS|Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053104|NCT01320085|FG002|Participant Flow|Binimetinib 60 mg BRAF|Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053105|NCT01320085|OG000|Outcome|Binimetinib 45 mg BRAF|Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11149285|NCT01870076|FG003|Participant Flow|Control, No Presence|No Presence in the room one hour prior to bed.
11149286|NCT01870076|OG000|Outcome|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
11053106|NCT01320085|OG001|Outcome|Binimetinib 45 mg NRAS|Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053107|NCT01320085|OG002|Outcome|Binimetinib 60 mg BRAF|Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053108|NCT01320085|EG000|Reported Event|Binimetinib 45 mg BRAF|Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053109|NCT01320085|EG001|Reported Event|Binimetinib 45 mg NRAS|Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053110|NCT01320085|EG002|Reported Event|Binimetinib 60 mg BRAF|Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11053111|NCT01320137|BG000|Baseline|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
11053112|NCT01320137|BG001|Baseline|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
11053113|NCT01320137|BG002|Baseline|Total|Total of all reporting groups
11053114|NCT01320137|FG000|Participant Flow|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
11053115|NCT01320137|FG001|Participant Flow|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
11053116|NCT01320137|OG000|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
11053117|NCT01320137|OG001|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
11053118|NCT01320137|EG000|Reported Event|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
11053119|NCT01320137|EG001|Reported Event|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
11053120|NCT01320150|BG000|Baseline|Non PPP|Those without Persistent Post-surgical Pain (PPP)
11053121|NCT01320150|BG001|Baseline|Persistent Post Surgical Pain (PPP)|Those with Persistent Post-surgical Pain (PPP)
11053122|NCT01320150|BG002|Baseline|Total|Total of all reporting groups
11053123|NCT01320150|FG000|Participant Flow|All Study Participants|Study Subjects with and without Persistent Post-operative Pain (PPP) at followup
11053124|NCT01320150|OG000|Outcome|PPP and Non-PPP|Study Subjects with PPP and without PPP at followup
11053125|NCT01320150|EG000|Reported Event|All Study Participants|Study Subjects with and without Persistent Post-operative Pain (PPP) at followup
11053126|NCT01320202|BG000|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months."
11053127|NCT01320202|BG001|Baseline|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 18 months."
11053128|NCT01320202|BG002|Baseline|Total|Total of all reporting groups
11053129|NCT01320202|FG000|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
11053130|NCT01320202|FG001|Participant Flow|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
11053131|NCT01320202|OG000|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
11053132|NCT01320202|OG001|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
11053133|NCT01320202|OG000|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
11053134|NCT01320202|OG001|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
11053135|NCT01320202|EG000|Reported Event|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
11053136|NCT01320202|EG001|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
11053137|NCT01320202|EG002|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
11053138|NCT01320293|BG000|Baseline|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
11053139|NCT01320293|FG000|Participant Flow|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
11053140|NCT01320293|OG000|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
11053141|NCT01320293|EG000|Reported Event|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
11053142|NCT01320553|BG000|Baseline|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
11053143|NCT01320553|BG001|Baseline|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
11053144|NCT01320553|BG002|Baseline|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
11053145|NCT01320553|BG003|Baseline|Placebo|"Placebo eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
11053146|NCT01320553|BG004|Baseline|Total|Total of all reporting groups
11053147|NCT01320553|FG000|Participant Flow|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
11053148|NCT01320553|FG001|Participant Flow|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
11053149|NCT01320553|FG002|Participant Flow|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
11053150|NCT01320553|FG003|Participant Flow|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
11053151|NCT01320553|OG000|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
11053152|NCT01320553|OG001|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
11053153|NCT01320553|OG002|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
11053154|NCT01320553|OG003|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
11053155|NCT01320553|EG000|Reported Event|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
11053156|NCT01320553|EG001|Reported Event|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
11053157|NCT01320553|EG002|Reported Event|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
11053158|NCT01320553|EG003|Reported Event|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
11053159|NCT01320722|BG000|Baseline|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
11053160|NCT01320722|BG001|Baseline|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
11053161|NCT01320722|BG002|Baseline|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
11053162|NCT01320722|BG003|Baseline|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
11053163|NCT01320722|BG004|Baseline|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
11053164|NCT01320722|BG005|Baseline|Total|Total of all reporting groups
11053165|NCT01320722|FG000|Participant Flow|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
11053166|NCT01320722|FG001|Participant Flow|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
11053167|NCT01320722|FG002|Participant Flow|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
11053168|NCT01320722|FG003|Participant Flow|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
11226689|NCT02377362|EG007|Reported Event|GLWL-01 Part B (150 mg, Twice a Day)|
11053169|NCT01320722|FG004|Participant Flow|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
11053170|NCT01320722|OG000|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
11053171|NCT01320722|OG001|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
11053172|NCT01320722|OG000|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
11053173|NCT01320722|OG001|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
11053174|NCT01320722|OG002|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
11053175|NCT01320722|OG002|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
11053176|NCT01320722|OG003|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
11053177|NCT01320722|OG004|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
11053178|NCT01320722|EG000|Reported Event|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
11053179|NCT01320722|EG001|Reported Event|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
11053180|NCT01320722|EG002|Reported Event|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
11053181|NCT01320722|EG003|Reported Event|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
11053182|NCT01320722|EG004|Reported Event|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
11053183|NCT01320735|BG000|Baseline|Advanced PCa|Participants with advanced PCa
11053184|NCT01320735|FG000|Participant Flow|Advanced Prostate Cancer (PCa)|Participants with advanced PCa
11053185|NCT01320735|OG000|Outcome|Advanced PCa|Participants with advanced PCa
11053186|NCT01320735|EG000|Reported Event|Advanced PCa|Participants with advanced PCa
11053187|NCT01320826|BG000|Baseline|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
11053188|NCT01320826|FG000|Participant Flow|Patients Undergoing Colonoscopy|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
11053189|NCT01320826|OG000|Outcome|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
11053190|NCT01320826|OG000|Outcome|Percentage of Successful Cecal Intubations|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)
11053191|NCT01320826|OG000|Outcome|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.
11226690|NCT02377362|EG008|Reported Event|GLWL-01 Part B (300 mg, Once a Day)|
11053192|NCT01320826|OG000|Outcome|Percentage of Males 50 Years and Older Undergoing First Time c|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."
11053193|NCT01320826|OG000|Outcome|Colonoscopy Complications|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.~Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).~All potential serious complications of colonoscopy will be externally adjudicated."
11053194|NCT01320826|OG000|Outcome|Withdraw Times, Minutes|
11053195|NCT01320826|OG000|Outcome|Patient Comfort During Colonoscopy|Patient discomfort on 5 point scale 0 is no discomfort; 1 is one or two episodes of discomfort, well tolerated; 2 is more than two episodes of discomfort adequately tolerated; 3 is significant discomfort experienced several times during the procedure; 4 is extreme discomfort experienced frequency throughout the procedure.
11053196|NCT01320826|OG000|Outcome|Patient Wait Time Satisfaction|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied~minimum score = 1 maximum score = 7"
11053197|NCT01320826|OG000|Outcome|Patient Satisfaction With Hospital Experience|Patient satisfaction with hospital experience measured on 7 point Likert scale. 7 is extremely satisfied, 1 is extremely dissatisfied.
11053198|NCT01320826|OG000|Outcome|Procedural Time|Procedural time was defined as the time from the first insertion of the colonoscope until it was removed from the anus, in minutes
11053199|NCT01320826|OG000|Outcome|Percentage of Patients Referred to a Specialist.|The percentage of patients who, after having a colonoscopy, are referred to another specialist for their gastrointestinal problem. A specialist was defined as a physician more specialized than the person performing the colonoscopy, and a referral was counted if the physician, at the time of colonoscopy, sent or anticipated sending the patient to a specialist for any reason, or if the patient believed they were being sent to a specialist.
11053200|NCT01320826|OG000|Outcome|Percentage of Females ≥ 50 Years With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."
11053201|NCT01320826|EG000|Reported Event|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
11053202|NCT01320943|BG000|Baseline|Stop TDF|Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline.
11053203|NCT01320943|BG001|Baseline|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
11053204|NCT01320943|BG002|Baseline|Total|Total of all reporting groups
11053205|NCT01320943|FG000|Participant Flow|Stop TDF|Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline.
11053206|NCT01320943|FG001|Participant Flow|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
11053207|NCT01320943|OG000|Outcome|Stop TDF|Participants stopped tenofovir disoproxil fumarate monotherapy at baseline.
11226691|NCT02377362|EG009|Reported Event|GLWL-01 Part B (450 mg, Once a Day)|
11053208|NCT01320943|OG001|Outcome|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
11053209|NCT01320943|OG000|Outcome|Stop TDF (TDF-Free)|Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free.
11053210|NCT01320943|OG001|Outcome|Restart TDF|Stop TDF participants who restarted TDF therapy
11053211|NCT01320943|OG002|Outcome|Continue TDF|Participants who continued TDF monotherapy 300 mg once daily.
11053212|NCT01320943|OG000|Outcome|Stop TDF|Participants stopped TDF monotherapy at baseline.
11053213|NCT01320943|OG000|Outcome|Stop TDF (TDF-Free)|Participants stopped TDF monotherapy at baseline. Participants in this group were TDF free.
11053214|NCT01320943|OG001|Outcome|Re-Start TDF|Stop TDF participants who restarted TDF therapy
11053215|NCT01320943|EG000|Reported Event|Stop TDF (TDF-Free) [Termination Emergent]|Participants stopped TDF monotherapy at baseline.
11053216|NCT01320943|EG001|Reported Event|Re-start TDF [TDF Emergent]|Stop TDF participants who restarted TDF therapy.
11053217|NCT01320943|EG002|Reported Event|Continue TDF [TDF Emergent]|Participants continued TDF monotherapy 300 mg once daily.
11053218|NCT01321073|BG000|Baseline|DelIVery for Pulmonary Arterial Hypertension Single Arm|"All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.~Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration."
11053219|NCT01321073|FG000|Participant Flow|DelIVery for Pulmonary Arterial Hypertension Single Arm|"All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.~Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration."
10847041|NCT00281580|OG007|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
10847042|NCT00281580|OG008|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
10847043|NCT00281580|OG009|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
11053220|NCT01321073|OG000|Outcome|DelIVery for Pulmonary Arterial Hypertension Single Arm|"All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.~Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration."
11053221|NCT01321073|EG000|Reported Event|Single Arm|"All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.~Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration."
11053222|NCT01321151|BG000|Baseline|Sugar Pill|"Placebo control~Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury."
11053223|NCT01321151|BG001|Baseline|Resveratrol|"Intervention~Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury."
11053224|NCT01321151|BG002|Baseline|Total|Total of all reporting groups
11053225|NCT01321151|FG000|Participant Flow|Sugar Pill|"Placebo control~Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury."
11053226|NCT01321151|FG001|Participant Flow|Resveratrol|"Intervention~Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury."
11149287|NCT01870076|OG001|Outcome|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
11149288|NCT01870076|OG002|Outcome|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
11149289|NCT01870076|OG003|Outcome|Control, No Presence|No Presence in the room one hour prior to bed.
11149290|NCT01870076|EG000|Reported Event|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
11149291|NCT01870076|EG001|Reported Event|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
11149292|NCT01870076|EG002|Reported Event|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
11149293|NCT01870076|EG003|Reported Event|Control, No Presence|No Presence in the room one hour prior to bed.
11149294|NCT01870297|BG000|Baseline|Placebo Part A|Part A Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
11149295|NCT01870297|BG001|Baseline|0.5 mg LY3025876|Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149296|NCT01870297|BG002|Baseline|1.5 mg LY3025876|Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149297|NCT01870297|BG003|Baseline|5.0 mg LY3025876|Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149298|NCT01870297|BG004|Baseline|15 mg LY3025876|Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11053227|NCT01321151|OG000|Outcome|Sugar Pill|"Placebo control~Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury."
11053228|NCT01321151|OG001|Outcome|Resveratrol|"Intervention~Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury."
11053229|NCT01321151|EG000|Reported Event|Sugar Pill|"Placebo control~Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury."
11053230|NCT01321151|EG001|Reported Event|Resveratrol|"Intervention~Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury."
11053231|NCT01321177|BG000|Baseline|Integrated Treatment|"Integrated program of treatments and services delivered by a coordinated team of providers.~Integrated Treatment: Integrated program of treatments and services delivered by a coordinated team of providers that includes:~education about schizophrenia and its treatment for the participants and their family members~medication for symptoms and preventing relapse that uses a computerized decision support system~strategies for managing the illness and building personal resilience~help getting back to school or work using a supported employment/education model"
11053232|NCT01321177|BG001|Baseline|Community Care|"Standard mental health treatments and services offered at the local agency.~Community Care: Standard mental health treatments and services offered at the local agency that may include :~medication for symptoms and preventing relapse~psychosocial therapy which may include a range of behavioral treatments and supportive services~Case management"
11053233|NCT01321177|BG002|Baseline|Total|Total of all reporting groups
11053234|NCT01321177|FG000|Participant Flow|Integrated Treatment|"Integrated program of treatments and services delivered by a coordinated team of providers.~Integrated Treatment: Integrated program of treatments and services delivered by a coordinated team of providers that includes:~education about schizophrenia and its treatment for the participants and their family members~medication for symptoms and preventing relapse that uses a computerized decision support system~strategies for managing the illness and building personal resilience~help getting back to school or work using a supported employment/education model"
11053235|NCT01321177|FG001|Participant Flow|Community Care|"Standard mental health treatments and services offered at the local agency.~Community Care: Standard mental health treatments and services offered at the local agency that may include :~medication for symptoms and preventing relapse~psychosocial therapy which may include a range of behavioral treatments and supportive services~Case management"
11053236|NCT01321177|OG000|Outcome|Integrated Treatment|"Integrated program of treatments and services delivered by a coordinated team of providers.~Integrated Treatment: Integrated program of treatments and services delivered by a coordinated team of providers that includes:~education about schizophrenia and its treatment for the participants and their family members~medication for symptoms and preventing relapse that uses a computerized decision support system~strategies for managing the illness and building personal resilience~help getting back to school or work using a supported employment/education model"
10847044|NCT00281580|OG010|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
11053237|NCT01321177|OG001|Outcome|Community Care|"Standard mental health treatments and services offered at the local agency.~Community Care: Standard mental health treatments and services offered at the local agency that may include :~medication for symptoms and preventing relapse~psychosocial therapy which may include a range of behavioral treatments and supportive services~Case management"
11053238|NCT01321177|EG000|Reported Event|Integrated Treatment|"Integrated program of treatments and services delivered by a coordinated team of providers.~Integrated Treatment: Integrated program of treatments and services delivered by a coordinated team of providers that includes:~education about schizophrenia and its treatment for the participants and their family members~medication for symptoms and preventing relapse that uses a computerized decision support system~strategies for managing the illness and building personal resilience~help getting back to school or work using a supported employment/education model"
11053239|NCT01321177|EG001|Reported Event|Community Care|"Standard mental health treatments and services offered at the local agency.~Community Care: Standard mental health treatments and services offered at the local agency that may include :~medication for symptoms and preventing relapse~psychosocial therapy which may include a range of behavioral treatments and supportive services~Case management"
11053240|NCT01321437|BG000|Baseline|Axitinib|"Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events.~pharmacological study: Correlative studies"
11053241|NCT01321437|FG000|Participant Flow|Axitinib|"Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events.~pharmacological study: Correlative studies"
11149299|NCT01870297|BG005|Baseline|Placebo + Liraglutide|Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
11149300|NCT01870297|BG006|Baseline|5.0 mg LY3025876 + Liraglutide|Part B:5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
10847045|NCT00281580|OG011|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
10847046|NCT00281580|OG012|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
10847047|NCT00281580|OG013|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
11053242|NCT01321437|OG000|Outcome|Axitinib|"Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events.~pharmacological study: Correlative studies"
11053243|NCT01321437|EG000|Reported Event|Axitinib|"Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events.~pharmacological study: Correlative studies"
11053244|NCT01321541|BG000|Baseline|Pixantrone + Rituximab|"Pixantrone and Rituximab~Pixantrone + Rituximab: Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered."
11053245|NCT01321541|BG001|Baseline|Gemcitabine + Rituximab|"Gemcitabine and Rituximab~Gemcitabine + Rituximab: Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered."
11053246|NCT01321541|BG002|Baseline|Total|Total of all reporting groups
11053247|NCT01321541|FG000|Participant Flow|Pixantrone + Rituximab|"Pixantrone and Rituximab~Pixantrone + Rituximab: Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered."
11053248|NCT01321541|FG001|Participant Flow|Gemcitabine + Rituximab|"Gemcitabine and Rituximab~Gemcitabine + Rituximab: Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered."
11053249|NCT01321541|OG000|Outcome|Pixantrone + Rituximab|"Pixantrone and Rituximab~Pixantrone + Rituximab: Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered."
11053250|NCT01321541|OG001|Outcome|Gemcitabine + Rituximab|"Gemcitabine and Rituximab~Gemcitabine + Rituximab: Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered."
11053251|NCT01321541|EG000|Reported Event|Pixantrone + Rituximab|"Pixantrone and Rituximab~Pixantrone + Rituximab: Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered."
11053252|NCT01321541|EG001|Reported Event|Gemcitabine + Rituximab|"Gemcitabine and Rituximab~Gemcitabine + Rituximab: Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered."
11053253|NCT01321554|BG000|Baseline|Randomization Phase: Lenvatinib 24 mg|Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
11053254|NCT01321554|BG001|Baseline|Randomization Phase: Placebo|Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
11053255|NCT01321554|BG002|Baseline|Total|Total of all reporting groups
11053256|NCT01321554|FG000|Participant Flow|Randomization Phase: Lenvatinib 24 mg|Participants received lenvatinib 24 milligram (mg), hard capsule, orally, once daily, until documentation of disease progression (confirmed by Investigator-Initiated Research [IIR]), development of unacceptable toxicity, or withdrawal of consent.
11053257|NCT01321554|FG001|Participant Flow|Randomization Phase: Placebo|Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
11053258|NCT01321554|FG002|Participant Flow|OOL, Treatment Period: Lenvatinib 24 mg|Participants received lenvatinib 24 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. OOL refers to Optional Open-Label.
11053259|NCT01321554|FG003|Participant Flow|OOL, Treatment Period: Lenvatinib 20 mg|Participants received lenvatinib 20 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.
11053260|NCT01321554|OG000|Outcome|Randomization Phase: Lenvatinib 24 mg|Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
10847048|NCT00281580|OG014|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
11053261|NCT01321554|OG001|Outcome|Randomization Phase: Placebo|Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
11053262|NCT01321554|EG000|Reported Event|Randomization Phase: Lenvatinib 24 mg|Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
11053263|NCT01321554|EG001|Reported Event|Randomization Phase: Placebo|Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
11149301|NCT01870297|BG007|Baseline|Total|Total of all reporting groups
11053264|NCT01321554|EG002|Reported Event|OOL, Treatment Period: Lenvatinib 24 mg|Participants received lenvatinib 24 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.
11053265|NCT01321554|EG003|Reported Event|OOL, Treatment Period: Lenvatinib 20 mg|Participants received lenvatinib 20 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.
11053266|NCT01321606|BG000|Baseline|Arm 1: Probiotic|"Subjects were given a capsule formulation of a 1x10^10 colony-forming units of probiotic L. rhamnosus HN001 to be taken once a day, for 4 weeks~Lactobacillus rhamnosus HN001: Subjects will be given a pill formulation of a probiotic L. rhamnosus HN001 to be taken once a day, at a dose of 1 x 10^10 organisms"
11053267|NCT01321606|BG001|Baseline|Arm 2: Placebo|"Placebo composed of identical inactive components to the active product, to be taken once daily for 4 weeks.~Placebo pill: composed of identical inactive components to the active product, given to be taken once daily for 4 weeks."
11053268|NCT01321606|BG002|Baseline|Total|Total of all reporting groups
11053269|NCT01321606|FG000|Participant Flow|Arm 1a: Extra-GI Probiotic|"Subjects with Extra-GI colonization at initial screening who were randomized to probiotic treatment.~Extra-GI colonization was defined as a positive PCR result for S. aureus from any swab of the nares, axillae or wound, with no positive result from swabs of the oropharynx, or peri-rectum.~Subjects were given a capsule formulation of a 1x10^10 colony-forming units of probiotic L. rhamnosus HN001 to be taken once a day, for 4 weeks."
11053270|NCT01321606|FG001|Participant Flow|Arm 2a: Extra-GI Placebo|"Subjects with Extra-GI colonization at initial screening who were randomized to placebo treatment.~Extra-GI colonization was defined as a positive PCR result for S. aureus from any swab of the nares, axillae or wound, with no positive result from swabs of the oropharynx, or peri-rectum.~Placebo pill: composed of identical inactive components to the active product, given to be taken once daily for 4 weeks."
11053271|NCT01321606|FG002|Participant Flow|Arm 1b: GI Probiotic|"Subjects with GI colonization at initial screening who were randomized to probiotic treatment.~GI colonization was defined as a positive PCR result for S. aureus from any swab of the oropharynx, or peri-rectum.~Subjects were given a capsule formulation of a 1x10^10 colony-forming units of probiotic L. rhamnosus HN001 to be taken once a day, for 4 weeks"
11053272|NCT01321606|FG003|Participant Flow|Arm 2b: GI Placebo|"Subjects with GI colonization at initial screening who were randomized to placebo treatment.~GI colonization was defined as a positive PCR result for S. aureus from any swab of the oropharynx, or peri-rectum.~Placebo pill: composed of identical inactive components to the active product, given to be taken once daily for 4 weeks."
11053273|NCT01321606|OG000|Outcome|Arm 1a: Extra-GI Probiotic|"Subjects with Extra-GI colonization at initial screening who were randomized to probiotic treatment.~Extra-GI colonization was defined as a positive PCR result for S. aureus from any swab of the nares, axillae or wound, with no positive result from swabs of the oropharynx, or peri-rectum.~Subjects were given a capsule formulation of a 1x10^10 colony-forming units of probiotic L. rhamnosus HN001 to be taken once a day, for 4 weeks"
11053274|NCT01321606|OG001|Outcome|Arm 2a: Extra-GI Placebo|"Subjects with Extra-GI colonization at initial screening who were randomized to placebo treatment.~Extra-GI colonization was defined as a positive PCR result for S. aureus from any swab of the nares, axillae or wound, with no positive result from swabs of the oropharynx, or peri-rectum.~Placebo pill: composed of identical inactive components to the active product, given to be taken once daily for 4 weeks."
11053275|NCT01321606|OG002|Outcome|Arm 1b: GI Probiotic|"Subjects with GI colonization at initial screening who were randomized to probiotic treatment.~GI colonization was defined as a positive PCR result for S. aureus from any swab of the oropharynx, or peri-rectum.~Subjects were given a capsule formulation of a 1x10^10 colony-forming units of probiotic L. rhamnosus HN001 to be taken once a day, for 4 weeks"
11053276|NCT01321606|OG003|Outcome|Arm 2b: GI Placebo|"Subjects with GI colonization at initial screening who were randomized to placebo treatment.~GI colonization was defined as a positive PCR result for S. aureus from any swab of the oropharynx, or peri-rectum.~Placebo pill: composed of identical inactive components to the active product, given to be taken once daily for 4 weeks."
11053277|NCT01321606|EG000|Reported Event|Arm 1: Extra-GI Probiotic|"Subjects with Extra-GI colonization at initial screening who were randomized to probiotic treatment. Subjects were given a capsule formulation of a 1x10^10 colony-forming units of probiotic L. rhamnosus HN001 to be taken once a day, for 4 weeks~Lactobacillus rhamnosus HN001: Subjects will be given a pill formulation of a probiotic L. rhamnosus HN001 to be taken once a day, at a dose of 1 x 10^10 organisms"
11053278|NCT01321606|EG001|Reported Event|Arm 2: Extra-GI Placebo|"Subjects with Extra-GI colonization at initial screening who were randomized to placebo treatment. Placebo composed of identical inactive components to the active product, to be taken once daily for 4 weeks.~Placebo pill: composed of identical inactive components to the active product, given to be taken once daily for 4 weeks."
11053279|NCT01321606|EG002|Reported Event|Arm 3: GI Probiotic|"Subjects with GI colonization at initial screening who were randomized to probiotic treatment. Subjects were given a capsule formulation of a 1x10^10 colony-forming units of probiotic L. rhamnosus HN001 to be taken once a day, for 4 weeks~Lactobacillus rhamnosus HN001: Subjects will be given a pill formulation of a probiotic L. rhamnosus HN001 to be taken once a day, at a dose of 1 x 10^10 organisms"
11053280|NCT01321606|EG003|Reported Event|Arm 4: GI Placebo|"Subjects with GI colonization at initial screening who were randomized to placebo treatment. Placebo composed of identical inactive components to the active product, to be taken once daily for 4 weeks.~Placebo pill: composed of identical inactive components to the active product, given to be taken once daily for 4 weeks."
11053281|NCT01321710|BG000|Baseline|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
11053282|NCT01321710|BG001|Baseline|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
11053283|NCT01321710|BG002|Baseline|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
11053284|NCT01321710|BG003|Baseline|Total|Total of all reporting groups
11053285|NCT01321710|FG000|Participant Flow|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
11053286|NCT01321710|FG001|Participant Flow|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
11053287|NCT01321710|FG002|Participant Flow|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
11053288|NCT01321710|OG000|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
11053289|NCT01321710|OG001|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
11053290|NCT01321710|OG001|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
11053291|NCT01321710|OG000|Outcome|Standard Immunization Care|Infants in this group received standard immunization care from their health care provider (may or may not have included prophylactic acetaminophen).
11053292|NCT01321710|OG001|Outcome|Prophylactic Acetaminophen|Infants in this group received prophylactic acetaminophen administered prior to immunization and 4 subsequent doses administered in the 24 hours following immunization.
11053293|NCT01321710|EG000|Reported Event|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
11053294|NCT01321710|EG001|Reported Event|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
11053295|NCT01321710|EG002|Reported Event|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
11053296|NCT01321723|BG000|Baseline|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
10847049|NCT00281580|OG000|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
11053297|NCT01321723|BG001|Baseline|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
11053298|NCT01321723|BG002|Baseline|Placebo|Placebo : matching tablets, once daily
11053299|NCT01321723|BG003|Baseline|Total|Total of all reporting groups
11053300|NCT01321723|FG000|Participant Flow|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily.
11053301|NCT01321723|FG001|Participant Flow|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily.
11053302|NCT01321723|FG002|Participant Flow|Placebo|Placebo : matching tablets, once daily
11053303|NCT01321723|OG000|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
11053304|NCT01321723|OG001|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
11053305|NCT01321723|OG002|Outcome|Placebo|Placebo : matching tablets, once daily
11053306|NCT01321723|EG000|Reported Event|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
11053307|NCT01321723|EG001|Reported Event|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
11053308|NCT01321723|EG002|Reported Event|Placebo|Placebo : matching tablets, once daily
11053309|NCT01321749|BG000|Baseline|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
11053310|NCT01321749|BG001|Baseline|Stroke Secondary Prevention|Procedure:stroke secondary prevention
11053311|NCT01321749|BG002|Baseline|Total|Total of all reporting groups
11053312|NCT01321749|FG000|Participant Flow|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
11053313|NCT01321749|FG001|Participant Flow|Stroke Secondary Prevention|Procedure:stroke secondary prevention
11053314|NCT01321749|OG000|Outcome|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
11053315|NCT01321749|OG001|Outcome|Stroke Secondary Prevention|Procedure:stroke secondary prevention
10847050|NCT00281580|OG001|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
10847051|NCT00281580|OG002|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
11053316|NCT01321749|EG000|Reported Event|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
11053317|NCT01321749|EG001|Reported Event|Stroke Secondary Prevention|Procedure:stroke secondary prevention
11053318|NCT01321879|BG000|Baseline|Telavancin|Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
11053319|NCT01321879|FG000|Participant Flow|Telavancin|Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
11053320|NCT01321879|OG000|Outcome|Telavancin|Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
11053321|NCT01321879|EG000|Reported Event|Telavancin|Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
11226692|NCT02377362|EG010|Reported Event|GLWL-01 Part B (450 mg, Twice a Day)|
11053322|NCT01322009|BG000|Baseline|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
11053323|NCT01322009|BG001|Baseline|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
11053324|NCT01322009|BG002|Baseline|Total|Total of all reporting groups
11053325|NCT01322009|FG000|Participant Flow|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
11053326|NCT01322009|FG001|Participant Flow|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
11053327|NCT01322009|OG000|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
11053328|NCT01322009|OG001|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
11053329|NCT01322009|EG000|Reported Event|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
11053330|NCT01322009|EG001|Reported Event|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
11053331|NCT01322022|BG000|Baseline|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
11053332|NCT01322022|BG001|Baseline|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
11349017|NCT04131517|FG000|Participant Flow|Part 1 Sequence A|Participants received padsevonil (PSL) tablets 100 milligrams (mg) up-titrated to 400 mg, orally twice daily (bid) from Day 1 to 6 followed by padsevonil 400 mg bid on Day 7 to 14 along with a single dose of oral contraceptive (OC) Microgynon® 30 (ethinylestradiol 30 microgram [mcg] + levonorgestrel 150 mcg) tablet on Day 13 and, then padsevonil down-titrated from 400 mg to 100 mg bid from Day 15 to 19 during first Treatment Period. Participants received a single dose of OC tablet on Day 34 during second Treatment Period. There was a Washout Period of 14 days between the two Treatment Periods.
11053333|NCT01322022|BG002|Baseline|Total|Total of all reporting groups
11053334|NCT01322022|FG000|Participant Flow|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
11053335|NCT01322022|FG001|Participant Flow|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
11053336|NCT01322022|OG000|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
11053337|NCT01322022|OG001|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
11053338|NCT01322022|EG000|Reported Event|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
11053339|NCT01322022|EG001|Reported Event|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
11053340|NCT01322048|BG000|Baseline|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
11053341|NCT01322048|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
11053342|NCT01322048|BG002|Baseline|Total|Total of all reporting groups
11053343|NCT01322048|FG000|Participant Flow|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
11053344|NCT01322048|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
11053345|NCT01322048|OG000|Outcome|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
11053346|NCT01322048|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
11053347|NCT01322048|EG000|Reported Event|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
11053348|NCT01322048|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
11053349|NCT01322347|BG000|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
11053350|NCT01322347|BG001|Baseline|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
11053351|NCT01322347|BG002|Baseline|Total|Total of all reporting groups
11053352|NCT01322347|FG000|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
11053353|NCT01322347|FG001|Participant Flow|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
11053354|NCT01322347|OG000|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
11053355|NCT01322347|OG001|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
11053356|NCT01322347|EG000|Reported Event|Stage 2 Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
11053357|NCT01322347|EG001|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
11053358|NCT01322347|EG002|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP)|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
11053359|NCT01322360|BG000|Baseline|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
11053360|NCT01322360|FG000|Participant Flow|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
11053361|NCT01322360|OG000|Outcome|Morphine Sulfate|Subjects received morphine sulfate either as oral solution or tablet.
11053362|NCT01322360|OG000|Outcome|Morphine Sulfate|"oral solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines~Morphine Sulfate"
11053363|NCT01322360|EG000|Reported Event|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
11053364|NCT01322386|BG000|Baseline|Oral Vancomycin-BIliary Atresia|Enrolled- 10, Participated - 10,Completed - 10 (Based on Annual Progress Report in Oct 2010)
11053365|NCT01322386|BG001|Baseline|Oral Vancomycin - PSC|Enrolled- 11, Participated - 10 ,Completed - 9 (Based on Annual Progress Report in Oct 2010)
11053366|NCT01322386|BG002|Baseline|Total|Total of all reporting groups
11053367|NCT01322386|FG000|Participant Flow|Oral Vancomycin-Biliary Atresia|Vancomycin: Oral 50mg/Kg per day for three months. Initially 10 infants with Biliary Atresia (BA) were planned for this study to determine if there was clinical response to oral vancomycin.
11053368|NCT01322386|FG001|Participant Flow|Oral Vancomycin/ Primary Sclerosing Cholangitis|Vancomycin: Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months. Initially 10 children with Primary Sclerosing Cholangitis (PSC) were planned for this study to determine if there was clinical response to oral vancomycin.
11053369|NCT01322386|OG000|Outcome|Liver Blood Test|BA -10/10 , PSC - 9/9 - All had improvement on Vancomycin therapy.
11053370|NCT01322386|OG001|Outcome|MRI / MRCP|BA-N/A, PSC - 7/7 showed improvement on Vancomycin therapy.
11053371|NCT01322386|OG002|Outcome|Liver Biopsy|BA - N/A , PSC - 4/4 who had Liver biopsies showed improvement on Vancomycin therapy.
11053372|NCT01322386|OG003|Outcome|Colon Biopsies|BA - N/A , PSC - 8/8- who had colonoscopies with colon biopsies showed improvement on Vancomycin therapy.
11053373|NCT01322386|OG004|Outcome|Liver Biopsy and/or MRI|BA-N/A , PSC- 8/9 participants showed improvement of liver biopsies and/or MRI on Vancomycin.
11053374|NCT01322386|EG000|Reported Event|BA/PSC -Oral Vancomycin|Oral Vancomycin is commercially available (Vancocin, ViroPharma Inc.) for treatment of gastrointestinal infection such as, Clostridium difficile infection. In fact, our published observation of using oral vancomycin in treating PSC was an incidental finding to our treatment for Cl. Difficile gastrointestinal infection in a child with PSC (J Pediatr Gastroenterol Nutr 27:580-3, 1998). Since oral vancomycin is poorly absorbed, no serious adverse events were anticipated in this study.
11149302|NCT01870297|FG000|Participant Flow|Placebo Part A|Part A Placebo for LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days.
11226693|NCT02377362|EG011|Reported Event|GLWL-01 Part B (600 mg, Twice a Day)|
11053375|NCT01322490|BG000|Baseline|PROSTVAC-V/F-TRICOM + GM-CSF Placebo|PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
11053376|NCT01322490|BG001|Baseline|PROSTVAC-V/F-TRICOM + GM-CSF|PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).
11053377|NCT01322490|BG002|Baseline|Placebo Control|Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
11053378|NCT01322490|BG003|Baseline|Total|Total of all reporting groups
11053379|NCT01322490|FG000|Participant Flow|PROSTVAC-V/F-TRICOM + GM-CSF Placebo|PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
11053380|NCT01322490|FG001|Participant Flow|PROSTVAC-V/F-TRICOM + GM-CSF|PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).
11053381|NCT01322490|FG002|Participant Flow|Placebo Control|Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
11053382|NCT01322490|OG000|Outcome|PROSTVAC-V/F-TRICOM + GM-CSF Placebo|PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
11053383|NCT01322490|OG001|Outcome|PROSTVAC-V/F-TRICOM + GM-CSF|PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).
11053384|NCT01322490|OG002|Outcome|Placebo Control|Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
11053385|NCT01322490|EG000|Reported Event|PROSTVAC-V/F-TRICOM + GM-CSF Placebo|PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
11053386|NCT01322490|EG001|Reported Event|PROSTVAC-V/F-TRICOM + GM-CSF|PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).
11053387|NCT01322490|EG002|Reported Event|Placebo Control|Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
11053388|NCT01322594|BG000|Baseline|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053389|NCT01322594|BG001|Baseline|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
11053390|NCT01322594|BG002|Baseline|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053391|NCT01322594|BG003|Baseline|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
10847052|NCT00281580|OG003|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
11053392|NCT01322594|BG004|Baseline|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053393|NCT01322594|BG005|Baseline|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053394|NCT01322594|BG006|Baseline|Total|Total of all reporting groups
11053395|NCT01322594|FG000|Participant Flow|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053396|NCT01322594|FG001|Participant Flow|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
11053397|NCT01322594|FG002|Participant Flow|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053398|NCT01322594|FG003|Participant Flow|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053399|NCT01322594|FG004|Participant Flow|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053400|NCT01322594|FG005|Participant Flow|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053401|NCT01322594|OG000|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
11053402|NCT01322594|OG001|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053403|NCT01322594|OG002|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053404|NCT01322594|OG003|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053405|NCT01322594|OG004|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053406|NCT01322594|OG005|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
11053407|NCT01322594|EG000|Reported Event|Placebo|
11053408|NCT01322594|EG001|Reported Event|MEDI2338 10 MG|
11053409|NCT01322594|EG002|Reported Event|MEDI2338 30 MG|
11053410|NCT01322594|EG003|Reported Event|MEDI2338 100 MG|
11053411|NCT01322594|EG004|Reported Event|MEDI2338 300 MG|
11053412|NCT01322594|EG005|Reported Event|MEDI2338 1000 MG|
11053413|NCT01322607|BG000|Baseline|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
11053414|NCT01322607|BG001|Baseline|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
11053415|NCT01322607|BG002|Baseline|Total|Total of all reporting groups
11053416|NCT01322607|FG000|Participant Flow|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
11053417|NCT01322607|FG001|Participant Flow|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
11053418|NCT01322607|OG000|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
11053419|NCT01322607|OG001|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
11053420|NCT01322607|EG000|Reported Event|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
11053421|NCT01322607|EG001|Reported Event|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
11053422|NCT01322633|BG000|Baseline|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
11053423|NCT01322633|BG001|Baseline|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
11226694|NCT02377362|EG012|Reported Event|GLWL-01 Part B Placebo|
10847053|NCT00281580|OG000|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
10847054|NCT00281580|OG001|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
11053424|NCT01322633|BG002|Baseline|Total|Total of all reporting groups
11053425|NCT01322633|FG000|Participant Flow|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
11053426|NCT01322633|FG001|Participant Flow|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
11053427|NCT01322633|OG000|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
11053428|NCT01322633|OG001|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
11053429|NCT01322633|EG000|Reported Event|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
11053430|NCT01322633|EG001|Reported Event|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
11149303|NCT01870297|FG001|Participant Flow|0.5 mg LY3025876|Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149304|NCT01870297|FG002|Participant Flow|1.5 mg LY3025876|Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149305|NCT01870297|FG003|Participant Flow|5.0 mg LY3025876|Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149306|NCT01870297|FG004|Participant Flow|15 mg LY3025876|Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149307|NCT01870297|FG005|Participant Flow|Placebo + Liraglutide|Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
11149308|NCT01870297|FG006|Participant Flow|5.0 mg LY3025876 + Lirgalutide|Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
11149309|NCT01870297|OG000|Outcome|Placebo Part A|Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
11053431|NCT01322815|BG000|Baseline|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
11053432|NCT01322815|BG001|Baseline|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
11053433|NCT01322815|BG002|Baseline|Total|Total of all reporting groups
11053434|NCT01322815|FG000|Participant Flow|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
11053435|NCT01322815|FG001|Participant Flow|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
11053436|NCT01322815|OG000|Outcome|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
11053437|NCT01322815|OG001|Outcome|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
11053438|NCT01322815|EG000|Reported Event|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
11053439|NCT01322815|EG001|Reported Event|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
11053440|NCT01322841|BG000|Baseline|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
11053441|NCT01322841|BG001|Baseline|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
11053442|NCT01322841|BG002|Baseline|Total|Total of all reporting groups
11053443|NCT01322841|FG000|Participant Flow|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
11053444|NCT01322841|FG001|Participant Flow|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
11053445|NCT01322841|OG000|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
11053446|NCT01322841|OG001|Outcome|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
11053447|NCT01322841|EG000|Reported Event|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
11053448|NCT01322841|EG001|Reported Event|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
11053449|NCT01322945|BG000|Baseline|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
11053450|NCT01322945|BG001|Baseline|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
11053451|NCT01322945|BG002|Baseline|Total|Total of all reporting groups
11053452|NCT01322945|FG000|Participant Flow|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
11053453|NCT01322945|FG001|Participant Flow|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
11053454|NCT01322945|OG000|Outcome|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
11053455|NCT01322945|OG001|Outcome|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
11053456|NCT01322945|OG000|Outcome|Endonasal Group|First 12 patients enrolled undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
11053457|NCT01322945|OG001|Outcome|Control Group|First 10 patients enrolled undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
11053458|NCT01322945|EG000|Reported Event|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
11149310|NCT01870297|OG001|Outcome|0.5 mg LY3025876|Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11053459|NCT01322945|EG001|Reported Event|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
11053460|NCT01323010|BG000|Baseline|Experimental Group|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
11053461|NCT01323010|BG001|Baseline|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
11053462|NCT01323010|BG002|Baseline|Total|Total of all reporting groups
11053463|NCT01323010|FG000|Participant Flow|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
11053464|NCT01323010|FG001|Participant Flow|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
11053465|NCT01323010|OG000|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
11053466|NCT01323010|OG001|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
11053467|NCT01323010|OG001|Outcome|Albuterol - Lower Dose (Control)|"Dosing was individualized according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
11053468|NCT01323010|OG000|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
11053469|NCT01323010|OG001|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
11053470|NCT01323010|OG000|Outcome|Experimental Group|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
11053471|NCT01323010|OG001|Outcome|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
11053472|NCT01323010|OG000|Outcome|Virus Detected|patients with any virus detected by PCR
11053473|NCT01323010|OG001|Outcome|No Virus Detected|patients with no virus detected by PCR
11053474|NCT01323010|OG000|Outcome|Rhinovirus Detected|patients with rhinovirus detected by PCR
11053475|NCT01323010|OG001|Outcome|No Rhinovirus Detected|patients with no rhinovirus detected by PCR
11053476|NCT01323010|OG000|Outcome|Arg16Gly Patients|Patients carrying the Arg16Gly genotype
11053477|NCT01323010|OG001|Outcome|Gly16Gly Patients|Patients carrying the Gly16Gly genotype
11053478|NCT01323010|OG002|Outcome|Arg16Arg Patients|Patients carrying the Arg16Arg genotype
11053479|NCT01323010|EG000|Reported Event|Experimental Group|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
11053480|NCT01323010|EG001|Reported Event|Control Group|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
11053481|NCT01323140|BG000|Baseline|Treatment|
11053482|NCT01323140|FG000|Participant Flow|Treatment|
11053483|NCT01323140|OG000|Outcome|Treatment|As specified in the Protocol, subjects were dose-titrated during treatment and subjects at all resulting dose levels were pooled for primary efficacy analysis. After dose-titration, 20 subjects were receiving TMTS at dose level B (one 48 cm2 TMTS) and 18 subjects were receiving TMTS at dose level C (one 48 cm2 and one 28 cm2 TMTS). See also Arm description.
11053484|NCT01323140|EG000|Reported Event|Treatment|
11053485|NCT01323153|BG000|Baseline|Dalcetrapib|dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
11053486|NCT01323153|BG001|Baseline|Placebo|placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
11053487|NCT01323153|BG002|Baseline|Total|Total of all reporting groups
11053488|NCT01323153|FG000|Participant Flow|Dalcetrapib|dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
11053489|NCT01323153|FG001|Participant Flow|Placebo|placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
11053490|NCT01323153|OG000|Outcome|Dalcetrapib|dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
11053491|NCT01323153|OG001|Outcome|Placebo|placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
11053492|NCT01323153|EG000|Reported Event|Dalcetrapib|dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
11053493|NCT01323153|EG001|Reported Event|Placebo|placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
11053494|NCT01323192|BG000|Baseline|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
11053495|NCT01323192|BG001|Baseline|Placebo|Participants received matching placebo orally once daily for 8 weeks.
11053496|NCT01323192|BG002|Baseline|Total|Total of all reporting groups
11053497|NCT01323192|FG000|Participant Flow|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
11053498|NCT01323192|FG001|Participant Flow|Placebo|Participants received matching placebo orally once daily for 8 weeks.
11053499|NCT01323192|OG000|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
11053500|NCT01323192|OG001|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
11053501|NCT01323192|EG000|Reported Event|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
11053502|NCT01323192|EG001|Reported Event|Placebo|Participants received matching placebo orally once daily for 8 weeks.
11053503|NCT01323270|BG000|Baseline|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
11053504|NCT01323270|BG001|Baseline|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
11053505|NCT01323270|BG002|Baseline|Total|Total of all reporting groups
11053506|NCT01323270|FG000|Participant Flow|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
11053507|NCT01323270|FG001|Participant Flow|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
11053508|NCT01323270|OG000|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
11053509|NCT01323270|OG001|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
11053510|NCT01323270|OG001|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month
11053511|NCT01323270|EG000|Reported Event|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
11053512|NCT01323270|EG001|Reported Event|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
11053513|NCT01323387|BG000|Baseline|Treatment|Interbody fusions with Anterior Plating
11053514|NCT01323387|FG000|Participant Flow|Treatment|Interbody fusions with Anterior Plating
11053515|NCT01323387|OG000|Outcome|Treatment|Interbody fusions with Anterior Plating
11053516|NCT01323387|OG000|Outcome|Physical Health Composite Score (PCS)|A self-reported quality of life assessment to measure a participant's interpretation of their physical well-being. A 15% improvement was considered a success.
11053517|NCT01323387|OG000|Outcome|Physical Health Composite Score (MCS)|A self-reported quality of life assessment to measure a participant's interpretation of their physical well-being. A 15% improvement was considered a success.
11053518|NCT01323387|EG000|Reported Event|Treatment|Interbody fusions with Anterior Plating
11053519|NCT01323478|BG000|Baseline|Vortioxetine 15 or 20 mg/Day|
11053520|NCT01323478|FG000|Participant Flow|Vortioxetine 15 or 20 mg/Day|
11053521|NCT01323478|OG000|Outcome|Vortioxetine 15 or 20 mg/Day|
11053522|NCT01323478|EG000|Reported Event|Vortioxetine 15 or 20 mg/Day|
11053523|NCT01323517|BG000|Baseline|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
11053524|NCT01323517|FG000|Participant Flow|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
11053525|NCT01323517|OG000|Outcome|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
11053526|NCT01323517|EG000|Reported Event|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
11053527|NCT01323530|BG000|Baseline|Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)|Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053528|NCT01323530|BG001|Baseline|Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)|Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053529|NCT01323530|BG002|Baseline|Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)|Participants received eribulin mesilate 2.0 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053530|NCT01323530|BG003|Baseline|Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)|Participants received eribulin mesilate 0.7 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053531|NCT01323530|BG004|Baseline|Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)|Participants received eribulin mesilate 1.1 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053532|NCT01323530|BG005|Baseline|Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053533|NCT01323530|BG006|Baseline|Phase 2: Eribulin Mesilate 1.4 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
11053534|NCT01323530|BG007|Baseline|Total|Total of all reporting groups
11053535|NCT01323530|FG000|Participant Flow|Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)|Participants received eribulin mesilate 1.2 milligrams per square meter (mg/m^2), injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of progressive disease (PD), undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053536|NCT01323530|FG001|Participant Flow|Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)|Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053537|NCT01323530|FG002|Participant Flow|Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)|Participants received eribulin mesilate 2.0 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053538|NCT01323530|FG003|Participant Flow|Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)|Participants received eribulin mesilate 0.7 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053539|NCT01323530|FG004|Participant Flow|Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)|Participants received eribulin mesilate 1.1 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053540|NCT01323530|FG005|Participant Flow|Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053541|NCT01323530|FG006|Participant Flow|Phase 2: Eribulin Mesilate 1.4 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
11149311|NCT01870297|OG002|Outcome|1.5 mg LY3025876|Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149312|NCT01870297|OG003|Outcome|5.0 mg LY3025876|Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149313|NCT01870297|OG004|Outcome|15 mg LY3025876|Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
10847055|NCT00281580|OG002|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
11053542|NCT01323530|OG000|Outcome|Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)|Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053543|NCT01323530|OG001|Outcome|Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)|Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053544|NCT01323530|OG002|Outcome|Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)|Participants received eribulin mesilate 2.0 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053545|NCT01323530|OG003|Outcome|Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)|Participants received eribulin mesilate 0.7 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053546|NCT01323530|OG004|Outcome|Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)|Participants received eribulin mesilate 1.1 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053547|NCT01323530|OG005|Outcome|Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053548|NCT01323530|OG000|Outcome|Phase 2: Eribulin Mesilate 1.4 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
11053549|NCT01323530|OG006|Outcome|Phase 2: Eribulin Mesilate 1.4 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
11053550|NCT01323530|EG000|Reported Event|Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)|Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053551|NCT01323530|EG001|Reported Event|Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)|Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053552|NCT01323530|EG002|Reported Event|Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)|Participants received eribulin mesilate 2.0 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
11053553|NCT01323530|EG003|Reported Event|Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)|Participants received eribulin mesilate 0.7 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
10847056|NCT00281580|OG003|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
11053554|NCT01323530|EG004|Reported Event|Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)|Participants received eribulin mesilate 1.1 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053555|NCT01323530|EG005|Reported Event|Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
11053556|NCT01323530|EG006|Reported Event|Phase 2: Eribulin Mesilate 1.4 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
11053557|NCT01323582|BG000|Baseline|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
11053558|NCT01323582|BG001|Baseline|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
11053559|NCT01323582|BG002|Baseline|Total|Total of all reporting groups
11053560|NCT01323582|FG000|Participant Flow|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
11053561|NCT01323582|FG001|Participant Flow|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
11053562|NCT01323582|OG000|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
11053563|NCT01323582|OG001|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
11053564|NCT01323582|OG000|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
11053565|NCT01323582|OG000|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
11053566|NCT01323582|EG000|Reported Event|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
11053567|NCT01323582|EG001|Reported Event|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
11053568|NCT01323595|BG000|Baseline|Celecoxib|"Celecoxib will be given for 6 days after surgery~Celecoxib : Celecoxib 200mg PO BID x 6 days"
11349018|NCT04131517|FG001|Participant Flow|Part 1 Sequence B|Participants received a single dose of OC tablet on Day 1 during first Treatment Period. Participants received padsevonil tablets 100 mg up-titrated to 400 mg, bid on Day 18 to 23 followed by padsevonil 400 mg bid on Day 24 to 31 along with a single dose of OC tablet on Day 30 and, then padsevonil down-titrated from 400 mg to 100 mg bid from Day 32 to 36 during second Treatment Period. There was a Washout Period of 14 days between the two Treatment Periods.
11053569|NCT01323595|BG001|Baseline|Sugar Pill|"Sugar pill for 6 days after surgery.~Sugar Pill : Sugar pill PO BID x 6 days"
11053570|NCT01323595|BG002|Baseline|Total|Total of all reporting groups
11053571|NCT01323595|FG000|Participant Flow|Celecoxib|"Celecoxib will be given for 5 days after surgery~Celecoxib : Celecoxib 200mg PO BID x 6 days"
11053572|NCT01323595|FG001|Participant Flow|Sugar Pill|"Sugar pill for 5 days after surgery.~Sugar Pill : Sugar pill PO BID x 6 days"
11053573|NCT01323595|OG000|Outcome|Placebo Treatment|Patients received placebo medication
11349019|NCT04131517|OG000|Outcome|Part 1 Oral Contraceptive Alone (PKS)|After OC intake on Day 34 through Day 41 at Sequence A and OC intake on Day 1 through Day 18 (prior to PSL intake) at Sequence B attributed to OC Alone Treatment Period. Participants formed the PKS.
11349020|NCT04131517|OG001|Outcome|Part 1 PSL + Oral Contraceptive (PKS)|After OC intake on Day 13 with PSL through Day 34 (prior to OC intake) at Sequence A and after OC intake on Day 30 with PSL through Day 43 at Sequence B attributed to PSL + OC Treatment Period. Participants formed the Pharmacokinetic Set (PKS).
11053574|NCT01323595|OG001|Outcome|Celecoxib|Patients received celecoxib
11053575|NCT01323595|OG000|Outcome|Celecoxib|"Celecoxib will be given for 6 days after surgery~Celecoxib: Celecoxib 200mg PO BID x 6 days"
11053576|NCT01323595|OG001|Outcome|Sugar Pill|"Sugar pill for 6 days after surgery.~Sugar Pill: Sugar pill PO BID x 6 days"
11053577|NCT01323595|EG000|Reported Event|Placebo Treatment|Patients received placebo medication
11053578|NCT01323595|EG001|Reported Event|Celecoxib|Patients received celecoxib
11053579|NCT01323621|BG000|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11349021|NCT04131517|OG000|Outcome|Part 2 Oral Contraceptive Alone|No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated.
11349022|NCT04131517|OG001|Outcome|Part 2 PSL + Oral Contraceptive|No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated.
11349023|NCT04131517|OG000|Outcome|Part 1 PSL + Oral Contraceptive (SS)|After OC intake on Day 13 with PSL through Day 34 (prior to OC intake) at Sequence A and after OC intake on Day 30 with PSL through Day 43 at Sequence B attributed to PSL + OC Treatment Period. Participants formed the Safety Set (SS).
11349024|NCT04131517|OG001|Outcome|Part 1 Oral Contraceptive Alone (SS)|After OC intake on Day 34 through Day 41 at Sequence A and OC intake on Day 1 through Day 18 (prior to PSL intake) at Sequence B attributed to OC Alone Treatment Period. Participants formed the SS.
11349025|NCT04131517|OG002|Outcome|Part 1 PSL Alone (SS)|First intake of PSL through Day 13 (prior to OC intake) at Sequence A and PSL intake on Day 18 through Day 30 (prior to OC intake) at Sequence B attributed to PSL Alone Treatment Period. Participants formed the SS.
11053580|NCT01323621|BG001|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11053581|NCT01323621|BG002|Baseline|Total|Total of all reporting groups
11053582|NCT01323621|FG000|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, Ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
11053583|NCT01323621|FG001|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11053584|NCT01323621|FG002|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11053585|NCT01323621|OG000|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11053586|NCT01323621|OG001|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11053587|NCT01323621|EG000|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11053588|NCT01323621|EG001|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11053589|NCT01323634|BG000|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11349026|NCT04131517|OG002|Outcome|Part 2 PSL Alone|No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated.
11053590|NCT01323634|BG001|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11053591|NCT01323634|BG002|Baseline|Total|Total of all reporting groups
11053592|NCT01323634|FG000|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
11053593|NCT01323634|FG001|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11053594|NCT01323634|FG002|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11349027|NCT04131517|OG000|Outcome|Part 1 PSL + Oral Contraceptive (PKS)|After OC intake on Day 13 with PSL through Day 34 (prior to OC intake) at Sequence A and after OC intake on Day 30 with PSL through Day 43 at Sequence B attributed to PSL + OC Treatment Period. Participants formed the Pharmacokinetic Set (PKS).
11053595|NCT01323634|OG000|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11053596|NCT01323634|OG001|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11053597|NCT01323634|EG000|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11053598|NCT01323634|EG001|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11053599|NCT01323647|BG000|Baseline|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
11053600|NCT01323647|BG001|Baseline|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
11053601|NCT01323647|BG002|Baseline|Total|Total of all reporting groups
11053602|NCT01323647|FG000|Participant Flow|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
11053603|NCT01323647|FG001|Participant Flow|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
11053604|NCT01323647|OG000|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
11053605|NCT01323647|OG001|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
11053606|NCT01323647|EG000|Reported Event|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
11226695|NCT02377427|BG000|Baseline|Part A: Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
11053607|NCT01323647|EG001|Reported Event|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
11053608|NCT01323660|BG000|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
11053609|NCT01323660|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12weeks.
11053610|NCT01323660|FG001|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
11053611|NCT01323660|FG002|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11053612|NCT01323660|FG003|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
11053613|NCT01323660|FG004|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
11053614|NCT01323660|FG005|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
11053615|NCT01323660|OG000|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
11053616|NCT01323660|OG001|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
11053617|NCT01323660|OG002|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11053618|NCT01323660|OG003|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
11053619|NCT01323660|OG004|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
11053620|NCT01323660|OG005|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
11053621|NCT01323660|EG000|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
11053622|NCT01323660|EG001|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
11053623|NCT01323660|EG002|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11053624|NCT01323660|EG003|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
11341938|NCT03693742|OG000|Outcome|18F-DCFPyL PET/CT Scan With MSG Drink|Participants who received MSG dissolved in juice, in a fasting state, prior to the administration of 18F-DCFPyL, in either the first or second PET/CT scan.
11053625|NCT01323660|EG004|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
11053626|NCT01323660|EG005|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
11053627|NCT01323673|BG000|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
11053628|NCT01323673|BG001|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
11053629|NCT01323673|BG002|Baseline|Total|Total of all reporting groups
11053630|NCT01323673|FG000|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
11053631|NCT01323673|FG001|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
11053632|NCT01323673|OG000|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
11053633|NCT01323673|OG001|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
11053634|NCT01323673|EG000|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
11053635|NCT01323673|EG001|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
11053636|NCT01323777|BG000|Baseline|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11053637|NCT01323777|FG000|Participant Flow|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11349028|NCT04131517|OG001|Outcome|Part 1 PSL Alone (PKS)|First intake of PSL through Day 13 (prior to OC intake) at Sequence A and PSL intake on Day 18 through Day 30 (prior to OC intake) at Sequence B attributed to PSL Alone Treatment Period. Participants formed the PKS.
11053638|NCT01323777|OG000|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11053639|NCT01323777|OG001|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11053640|NCT01323777|OG002|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11053641|NCT01323777|OG003|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11053642|NCT01323777|OG004|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11053643|NCT01323777|OG000|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11053644|NCT01323777|OG001|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11053645|NCT01323777|OG002|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11053646|NCT01323777|EG000|Reported Event|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11053647|NCT01323790|BG000|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
11053648|NCT01323790|BG001|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11053649|NCT01323790|BG002|Baseline|Placebo|Placebo QD, oral treatment
11053650|NCT01323790|BG003|Baseline|Total|Total of all reporting groups
11349029|NCT04131517|OG000|Outcome|Part 2 PSL + Oral Contraceptive|No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated.
11053651|NCT01323790|FG000|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
11053652|NCT01323790|FG001|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11053653|NCT01323790|FG002|Participant Flow|Placebo|Placebo QD, oral treatment
11053654|NCT01323790|OG000|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
11053655|NCT01323790|OG001|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11053656|NCT01323790|OG002|Outcome|Placebo|Placebo QD, oral treatment
11053657|NCT01323790|EG000|Reported Event|NKTR-118 12.5 mg|
11053658|NCT01323790|EG001|Reported Event|NKTR-118 25 mg|
11053659|NCT01323790|EG002|Reported Event|Placebo|
11053660|NCT01323855|BG000|Baseline|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053661|NCT01323855|BG001|Baseline|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053662|NCT01323855|BG002|Baseline|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053663|NCT01323855|BG003|Baseline|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11349030|NCT04131517|OG001|Outcome|Part 2 PSL Alone|No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated.
11053664|NCT01323855|BG004|Baseline|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053665|NCT01323855|BG005|Baseline|Total|Total of all reporting groups
11053666|NCT01323855|FG000|Participant Flow|Part 1: Severe Renal Impairment|Participants with severe chronic renal impairment (CRI), defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053667|NCT01323855|FG001|Participant Flow|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053668|NCT01323855|FG002|Participant Flow|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053669|NCT01323855|FG003|Participant Flow|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053670|NCT01323855|FG004|Participant Flow|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053671|NCT01323855|OG000|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053672|NCT01323855|OG001|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053673|NCT01323855|OG002|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053674|NCT01323855|OG003|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053675|NCT01323855|OG004|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053676|NCT01323855|EG000|Reported Event|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053677|NCT01323855|EG001|Reported Event|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053678|NCT01323855|EG002|Reported Event|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053679|NCT01323855|EG003|Reported Event|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11053680|NCT01323855|EG004|Reported Event|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
11349031|NCT04131517|EG000|Reported Event|Part 1 PSL + Oral Contraceptive (SS)|After OC intake on Day 13 with PSL through Day 34 (prior to OC intake) at Sequence A and after OC intake on Day 30 with PSL through Day 43 at Sequence B attributed to PSL + OC Treatment Period. Participants formed the Safety Set (SS).
11053681|NCT01323920|BG000|Baseline|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
11053682|NCT01323920|FG000|Participant Flow|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
11053683|NCT01323920|OG000|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
11053684|NCT01323920|EG000|Reported Event|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
11053685|NCT01323946|BG000|Baseline|GSK1562902A 6 to 12 M Group|Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053686|NCT01323946|BG001|Baseline|GSK1562902A 12 to 24 M Group|Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053687|NCT01323946|BG002|Baseline|GSK1562902A 24 to 36 M Group|Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053688|NCT01323946|BG003|Baseline|Total|Total of all reporting groups
11053689|NCT01323946|FG000|Participant Flow|GSK1562902A 6 to 12 M Group|Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053690|NCT01323946|FG001|Participant Flow|GSK1562902A 12 to 24 M Group|Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053691|NCT01323946|FG002|Participant Flow|GSK1562902A 24 to 36 M Group|Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11149314|NCT01870297|OG005|Outcome|Placebo + Liraglutide|Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
11053692|NCT01323946|OG000|Outcome|GSK1562902A 6 to 12 M Group|Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053693|NCT01323946|OG001|Outcome|GSK1562902A 12 to 24 M Group|Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053694|NCT01323946|OG002|Outcome|GSK1562902A 24 to 36 M Group|Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053695|NCT01323946|OG003|Outcome|GSK1562902A Group|Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053696|NCT01323946|OG003|Outcome|GSK1562902A Group|Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.
11053697|NCT01323946|EG000|Reported Event|GSK1562902A 6 to 12 M Group|Subjects between 6 and 12 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053698|NCT01323946|EG001|Reported Event|GSK1562902A 12 to 24 M Group|Subjects between 12 and 24 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053699|NCT01323946|EG002|Reported Event|GSK1562902A 24 to 36 M Group|Subjects between 24 and 36 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
11053700|NCT01323959|BG000|Baseline|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053701|NCT01323959|BG001|Baseline|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053702|NCT01323959|BG002|Baseline|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053703|NCT01323959|BG003|Baseline|Total|Total of all reporting groups
11053704|NCT01323959|FG000|Participant Flow|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053705|NCT01323959|FG001|Participant Flow|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053706|NCT01323959|FG002|Participant Flow|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053707|NCT01323959|OG000|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053708|NCT01323959|OG001|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053709|NCT01323959|OG002|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053710|NCT01323959|EG000|Reported Event|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053711|NCT01323959|EG001|Reported Event|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053712|NCT01323959|EG002|Reported Event|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
11053713|NCT01323972|BG000|Baseline|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053714|NCT01323972|BG001|Baseline|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11149315|NCT01870297|OG006|Outcome|5.0 mg LY3025876 + Liraglutide|Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
11053715|NCT01323972|BG002|Baseline|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053716|NCT01323972|BG003|Baseline|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053717|NCT01323972|BG004|Baseline|Total|Total of all reporting groups
11053718|NCT01323972|FG000|Participant Flow|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053719|NCT01323972|FG001|Participant Flow|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053720|NCT01323972|FG002|Participant Flow|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053721|NCT01323972|FG003|Participant Flow|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053722|NCT01323972|OG000|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053723|NCT01323972|OG001|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053724|NCT01323972|OG002|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053725|NCT01323972|OG003|Outcome|GSK 257049-Pooled Group|This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
11053726|NCT01323972|OG004|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053727|NCT01323972|OG003|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053728|NCT01323972|EG000|Reported Event|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053729|NCT01323972|EG001|Reported Event|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053730|NCT01323972|EG002|Reported Event|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
10847057|NCT00281580|OG009|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
11053731|NCT01323972|EG003|Reported Event|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
11053732|NCT01323998|BG000|Baseline|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053733|NCT01323998|BG001|Baseline|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053734|NCT01323998|BG002|Baseline|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053735|NCT01323998|BG003|Baseline|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053736|NCT01323998|BG004|Baseline|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053737|NCT01323998|BG005|Baseline|Total|Total of all reporting groups
11053738|NCT01323998|FG000|Participant Flow|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram (mg), or a procedure code for prostate surgery
11053739|NCT01323998|FG001|Participant Flow|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053740|NCT01323998|FG002|Participant Flow|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053741|NCT01323998|FG003|Participant Flow|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053742|NCT01323998|FG004|Participant Flow|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053743|NCT01323998|OG000|Outcome|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053744|NCT01323998|OG001|Outcome|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053745|NCT01323998|OG002|Outcome|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053746|NCT01323998|OG003|Outcome|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053747|NCT01323998|OG004|Outcome|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11226696|NCT02377427|BG001|Baseline|Part A: Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
11053748|NCT01323998|EG000|Reported Event|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053749|NCT01323998|EG001|Reported Event|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053750|NCT01323998|EG002|Reported Event|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053751|NCT01323998|EG003|Reported Event|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053752|NCT01323998|EG004|Reported Event|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
11053753|NCT01324024|BG000|Baseline|All Study Participants|Participants were randomized to receive either Lisdexampethamine in titrated doses (20mg/d- 60mg/d) or Placebo tablets (matching Lisdexamphetamine).
11053754|NCT01324024|FG000|Participant Flow|Lisdexamfetamine, Then Placebo|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks) followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
11226697|NCT02377427|BG002|Baseline|Total|Total of all reporting groups
11341939|NCT03693742|OG001|Outcome|18F-DCFPyL PET/CT Scan With Placebo Drink|Participants who received the Placebo juice, in a fasting state, prior to the administration of 18F-DCFPyL, in either the first or second PET/CT scan.
11053755|NCT01324024|FG001|Participant Flow|Placebo First, Then Lisdexamfetamine|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks, followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks).
11053756|NCT01324024|OG000|Outcome|Baseline|
11053757|NCT01324024|OG001|Outcome|Lisdexamfetamine|Participants who received Lisdexamfetamine 20
11053758|NCT01324024|OG002|Outcome|Sugar Pill|"Placebo pill, capsules~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
11053759|NCT01324024|OG001|Outcome|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
11053760|NCT01324024|OG001|Outcome|Lisdexamfetamine|Participants received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks).
11053761|NCT01324024|OG002|Outcome|Placebo|Participants received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
11053762|NCT01324024|EG000|Reported Event|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
11053763|NCT01324024|EG001|Reported Event|Sugar Pill|"Placebo pill, capsules~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
11053764|NCT01324102|BG000|Baseline|Yoga Therapy Intervention|Intervention: Yoga therapy was 8 week class for two times per week
10847058|NCT00281580|OG001|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
11053765|NCT01324102|BG001|Baseline|Wait List Control|Wait List control: The wait list control did not receive an intervention.
11053766|NCT01324102|BG002|Baseline|Total|Total of all reporting groups
11053767|NCT01324102|FG000|Participant Flow|Yoga Therapy Intervention|"Intervention~Yoga therapy received an 8 week 2x weekly Yoga therapy class."
11053768|NCT01324102|FG001|Participant Flow|Wait List Control|Wait List control received no intervention for 8 weeks, then joined the yoga group
10847059|NCT00281580|OG001|Outcome|Telmisartan Monotherapy|Telmisartan 20/40/80mg tablet, QD in morning
10847060|NCT00281580|OG002|Outcome|Amlodipine Monotherapy|encapsulated Amlodipine 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
11053769|NCT01324102|OG000|Outcome|Pre Group Values|Patient Reported Outcome Measurement System values for all participants prior to participation in 8 session Yoga Therapy with home practice
11053770|NCT01324102|OG001|Outcome|Post Group Values|Patient Reported Outcome Measurement System values for all participants after participation in 8 session Yoga Therapy with home practice
11053771|NCT01324102|EG000|Reported Event|Yoga Therapy|"Received yoga therapy.~One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza."
11053772|NCT01324102|EG001|Reported Event|Wait List|"Received no yoga therapy for 8 weeks while the intervention group received yoga therapy~One participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia."
11053773|NCT01324102|EG002|Reported Event|Wait List on Yoga Therapy|"Received yoga therapy after an 8 week wait.~No participants were hospitalized."
11053774|NCT01324128|BG000|Baseline|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
11053775|NCT01324128|BG001|Baseline|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
11053776|NCT01324128|BG002|Baseline|Total|Total of all reporting groups
11053777|NCT01324128|FG000|Participant Flow|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
11053778|NCT01324128|FG001|Participant Flow|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
11053779|NCT01324128|FG002|Participant Flow|PA21 (MD) Stage 2|PA21 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1
11053780|NCT01324128|FG003|Participant Flow|PA21-1 (LD) Stage 2|PA21-1 (1.25 g/day) Low Dose (LD) comparator for Stage 2.
11053781|NCT01324128|OG000|Outcome|PA21 (MD) Stage 2|PA21 Stage 2 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
11053782|NCT01324128|OG001|Outcome|PA21-1 (LD) Stage 2|PA21-1 Low Dose (LD) comparator (1.25 g/day) for Stage 2
11053783|NCT01324128|OG000|Outcome|PA21 (2.5 g Tablet) Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
11053784|NCT01324128|OG001|Outcome|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
11053785|NCT01324128|EG000|Reported Event|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
11053786|NCT01324128|EG001|Reported Event|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
11053787|NCT01324128|EG002|Reported Event|PA21-1 (LD) Stage 2|PA21-1 (1.25 g tablet). Low Dose (LD) comparator (1.25 g/day) for Stage 2.
11053788|NCT01324128|EG003|Reported Event|PA21 (MD) Stage 2|PA21 (2.5g tablet) Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
11053789|NCT01324141|BG000|Baseline|1/Chemo + Radiation|"Chemo + Radiation~Tempol: Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT).~5-Fluorouracil: 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29.~Mitomycin-C: Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29~Radiation Therapy: Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics."
11149316|NCT01870297|OG000|Outcome|0.5 mg LY3025876|Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149317|NCT01870297|OG001|Outcome|1.5 mg LY3025876|Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149318|NCT01870297|OG002|Outcome|5.0 mg LY3025876|Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11053790|NCT01324141|FG000|Participant Flow|1/Chemo + Radiation|"Chemo + Radiation~Tempol: Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT).~5-Fluorouracil: 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29.~Mitomycin-C: Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29~Radiation Therapy: Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics."
11053791|NCT01324141|OG000|Outcome|MTS-01 Grade 1|Grade 1 is mild adverse events.
11053792|NCT01324141|OG001|Outcome|MTS-01 Grade 2|Grade 2 is moderate adverse events.
11053793|NCT01324141|OG002|Outcome|MTS-01 Grade 3|Grade 3 is severe adverse events.
11053794|NCT01324141|OG003|Outcome|5FU/MMC/IMRT Grade 2|Grade 2 is moderate adverse events.
11053795|NCT01324141|OG004|Outcome|5-FU/MMC/IMRT Grade 3-4|Grade 3 is severe adverse events and Grade 4 is life threatening adverse events.
11053796|NCT01324141|OG000|Outcome|1/Chemo + Radiation|"Chemo + Radiation~Tempol: Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT).~5-Fluorouracil: 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29.~Mitomycin-C: Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29~Radiation Therapy: Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics."
11053797|NCT01324141|OG000|Outcome|Gluteal Cleft|MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC) applied to gluteal cleft. Intensity-modulated Radiotherapy (IMRT) administered.
11053798|NCT01324141|OG001|Outcome|Right Inguinal Area|"MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC) applied to right inguinal area.~Intensity-modulated Radiotherapy (IMRT) administered."
11053799|NCT01324141|OG002|Outcome|Left Inguinal Area|"MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC) applied to left inguinal area.~Intensity-modulated Radiotherapy (IMRT) administered."
11053800|NCT01324141|OG003|Outcome|Left Inguinal Control (C1)|Control site within the treatment area. Radiation only.
11053801|NCT01324141|OG004|Outcome|Umbilical Control (C2)|Control site outside of the treatment field. MTS-01 only.
11053802|NCT01324141|EG000|Reported Event|1/Chemo + Radiation|"Chemo + Radiation~Tempol: Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT).~5-Fluorouracil: 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29.~Mitomycin-C: Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29~Radiation Therapy: Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics."
11053803|NCT01324232|BG000|Baseline|Placebo|Participants received one matching placebo capsule in the morning during the first 7 days of the study. Participants then received one matching placebo capsule twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053804|NCT01324232|BG001|Baseline|AVP-923-20|Participants received one capsule containing 20 milligrams (mg) dextromethorphan (DM) and 10 mg quinidine (Q) (AVP-923-20) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-20 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053805|NCT01324232|BG002|Baseline|AVP-923-30|Participants received one capsule containing 30 mg DM and 10 mg Q (AVP-923-30) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-30 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053806|NCT01324232|BG003|Baseline|AVP-923-45|Participants received one capsule containing 45 mg DM and 10 mg Q (AVP-923-45) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-45 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053807|NCT01324232|BG004|Baseline|Total|Total of all reporting groups
11053808|NCT01324232|FG000|Participant Flow|Placebo|Participants received one matching placebo capsule in the morning during the first 7 days of the study. Participants then received one matching placebo capsule twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053809|NCT01324232|FG001|Participant Flow|AVP-923-20|Participants received one capsule containing 20 milligrams (mg) dextromethorphan (DM) and 10 mg quinidine (Q) (AVP-923-20) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-20 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053810|NCT01324232|FG002|Participant Flow|AVP-923-30|Participants received one capsule containing 30 mg DM and 10 mg Q (AVP-923-30) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-30 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053811|NCT01324232|FG003|Participant Flow|AVP-923-45|Participants received one capsule containing 45 mg DM and 10 mg Q (AVP-923-45) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-45 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053812|NCT01324232|OG000|Outcome|Placebo|Participants received one matching placebo capsule in the morning during the first 7 days of the study. Participants then received one matching placebo capsule twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053813|NCT01324232|OG001|Outcome|AVP-923-20|Participants received one capsule containing 20 milligrams (mg) dextromethorphan (DM) and 10 mg quinidine (Q) (AVP-923-20) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-20 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053814|NCT01324232|OG002|Outcome|AVP-923-30|Participants received one capsule containing 30 mg DM and 10 mg Q (AVP-923-30) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-30 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11149319|NCT01870297|OG003|Outcome|15 mg LY3025876|Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11053815|NCT01324232|OG003|Outcome|AVP-923-45|Participants received one capsule containing 45 mg DM and 10 mg Q (AVP-923-45) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-45 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053816|NCT01324232|OG004|Outcome|Total|All participants who received placebo, AVP-923-20, AVP-923-30, or AVP-923-45 treatments during the study.
11053817|NCT01324232|OG004|Outcome|AVP-923-20 and AVP-923-30|Participants received either AVP-923-20 or AVP-923-30 in the morning during the first 7 days of the study. Participants then received one capsule of AVP-20 or AVP-923-30 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053818|NCT01324232|OG005|Outcome|AVP-923-30 and AVP-923-45|Participants received either AVP-923-30 or AVP-923-45 in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-30 or AVP-923-45 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053819|NCT01324232|OG006|Outcome|All AVP-923|All participants receiving AVP-923-20, AVP-923-30, or AVP-923-45.
11053820|NCT01324232|OG004|Outcome|Total|All participants receiving placebo, AVP-923-20, AVP-923-30, or AVP-923-45.
11053821|NCT01324232|EG000|Reported Event|Placebo|Participants received one matching placebo capsule in the morning during the first 7 days of the study. Participants then received one matching placebo capsule twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053822|NCT01324232|EG001|Reported Event|AVP-923-20|Participants received one capsule containing 20 milligrams (mg) dextromethorphan (DM) and 10 mg quinidine (Q) (AVP-923-20) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-20 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053823|NCT01324232|EG002|Reported Event|AVP-923-30|Participants received one capsule containing 30 mg DM and 10 mg Q (AVP-923-30) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-30 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053824|NCT01324232|EG003|Reported Event|AVP-923-45|Participants received one capsule containing 45 mg DM and 10 mg Q (AVP-923-45) in the morning during the first 7 days of the study. Participants then received one capsule of AVP-923-45 twice daily (approximately every 12 hours) during the remaining 11 weeks of the study to complete 12 weeks of treatment.
11053825|NCT01324271|BG000|Baseline|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
11053826|NCT01324271|FG000|Participant Flow|Tympanostomy Tube Placement (Lead-In Procedures)|"Acclarent Tympanostomy Tube Delivery system (TTDS):~Placement of tympanostomy tube under local anesthesia in office/clinic setting or under general anesthesia in operating room."
11053827|NCT01324271|FG001|Participant Flow|Tympanostomy Tube Placement (Study Cohort)|Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting
11053828|NCT01324271|OG000|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
11053829|NCT01324271|OG000|Outcome|Tube Placement Using the TTDS in Office/Clinic Setting|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
11053830|NCT01324271|OG000|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
11053831|NCT01324271|EG000|Reported Event|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS).
11053832|NCT01324310|BG000|Baseline|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Ketoconazole 400 mg oral once daily on Days 4-8"
10847061|NCT00281580|OG003|Outcome|Combination Therapy|Telmisartan 20/40/80mg tablet plus 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
10847062|NCT00281580|EG000|Reported Event|PLACEBO|
11053833|NCT01324310|FG000|Participant Flow|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8~Ketoconazole 400 mg oral once daily on Days 4-8"
11053834|NCT01324310|OG000|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
11053835|NCT01324310|OG001|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
11053836|NCT01324310|OG000|Outcome|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
11053837|NCT01324310|EG000|Reported Event|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
11053838|NCT01324323|BG000|Baseline|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Rifampin 600 mg oral once daily on Days 4-8"
11053839|NCT01324323|FG000|Participant Flow|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Rifampin 600 mg oral once daily on Days 4-8"
11053840|NCT01324323|OG000|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
11053841|NCT01324323|OG001|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8.
11053842|NCT01324323|OG000|Outcome|Romidepsin Day 1|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.~Rifampin 600 mg oral once daily on Days 4-8"
11053843|NCT01324323|OG001|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
11053844|NCT01324323|OG000|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1
11053845|NCT01324323|OG001|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8.
11053846|NCT01324323|OG000|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
11053847|NCT01324323|OG001|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8
11053848|NCT01324323|OG000|Outcome|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Days 1 and 8. Rifampin 600 mg oral once daily on Days 4-8
11053849|NCT01324323|EG000|Reported Event|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8 and Rifampin 600 mg oral once daily on Days 4-8.
11053850|NCT01324349|BG000|Baseline|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
11053851|NCT01324349|BG001|Baseline|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
11053852|NCT01324349|BG002|Baseline|Total|Total of all reporting groups
11053853|NCT01324349|FG000|Participant Flow|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
11053854|NCT01324349|FG001|Participant Flow|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
11053855|NCT01324349|OG000|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
11053856|NCT01324349|OG001|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
11053857|NCT01324349|EG000|Reported Event|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
11053858|NCT01324349|EG001|Reported Event|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
11053859|NCT01324388|BG000|Baseline|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
11053860|NCT01324388|BG001|Baseline|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
11053861|NCT01324388|BG002|Baseline|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
11053862|NCT01324388|BG003|Baseline|Total|Total of all reporting groups
10847063|NCT00281580|EG001|Reported Event|Telmisartan 20 mg (T20)|
11053863|NCT01324388|FG000|Participant Flow|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
11053864|NCT01324388|FG001|Participant Flow|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
11053865|NCT01324388|FG002|Participant Flow|Part 2: LY2189265 First, Then LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study)."
11053866|NCT01324388|FG003|Participant Flow|Part 2: LY2189265 + Metoprolol First, Then LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 1 in Part 2 of the study.~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study)."
11053867|NCT01324388|OG000|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
11053868|NCT01324388|OG001|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
11053869|NCT01324388|OG000|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
11053870|NCT01324388|OG000|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
11149320|NCT01870297|OG004|Outcome|LY3025876 + Liraglutide|Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
11149321|NCT01870297|OG001|Outcome|1.5 mg LY3025876|Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days
11053871|NCT01324388|OG000|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 ; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
11053872|NCT01324388|EG000|Reported Event|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
11053873|NCT01324388|EG001|Reported Event|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
11053874|NCT01324388|EG002|Reported Event|Part 2: LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 in Part 2 of the study.~Time frame: Treatment 1"
11053875|NCT01324388|EG003|Reported Event|Part 2: Metoprolol|"Metoprolol: 100 milligrams (mg), oral, on Days 1 through 4 of Treatment 2 in Part 2 of the study.~Time frame: Days 1 to 4 of Treatment 2"
11053876|NCT01324388|EG004|Reported Event|Part 2: LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 5 through 7 of Treatment 2 in Part 2 of the study.~Time frame: Day 5 to end of Treatment 2"
11053877|NCT01324401|BG000|Baseline|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will have the opportunity to cross over to active therapy.
11053878|NCT01324401|BG001|Baseline|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
11053879|NCT01324401|BG002|Baseline|Total|Total of all reporting groups
11053880|NCT01324401|FG000|Participant Flow|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
11053881|NCT01324401|FG001|Participant Flow|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
11053882|NCT01324401|OG000|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
11053883|NCT01324401|OG001|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
11053884|NCT01324401|EG000|Reported Event|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
11053885|NCT01324401|EG001|Reported Event|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
11053886|NCT01324440|BG000|Baseline|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
11053887|NCT01324440|BG001|Baseline|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
11053888|NCT01324440|BG002|Baseline|Total|Total of all reporting groups
11053889|NCT01324440|FG000|Participant Flow|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
11053890|NCT01324440|FG001|Participant Flow|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
11053891|NCT01324440|OG000|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
11053892|NCT01324440|OG001|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
11053893|NCT01324440|EG000|Reported Event|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
11053894|NCT01324440|EG001|Reported Event|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
11149322|NCT01870297|OG004|Outcome|5.0 mg LY3025876 + Liraglutide|Part B:5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
10847064|NCT00281580|EG002|Reported Event|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|
11053895|NCT01324453|BG000|Baseline|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
11053896|NCT01324453|BG001|Baseline|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
11053897|NCT01324453|BG002|Baseline|Total|Total of all reporting groups
11053898|NCT01324453|FG000|Participant Flow|Post Conditioning + Percutaneous Coronary Intervertion (PCI)|Post Conditioning + Primary PCI: Four, 30-second percutaneous transluminal coronary angioplasty (PTCA) balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to PCI as clinically indicated.
11053899|NCT01324453|FG001|Participant Flow|Standard Percutaneous Coronary Internvention (PCI)|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
11053900|NCT01324453|OG000|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
11053901|NCT01324453|OG001|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
11053902|NCT01324453|EG000|Reported Event|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
11053903|NCT01324453|EG001|Reported Event|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
11053904|NCT01324518|BG000|Baseline|Low Dose of ORM-12741|ORM-12741: 60mg twice a day
11053905|NCT01324518|BG001|Baseline|High Dose of ORM-12741|ORM-12741: 200mg twice a day
11053906|NCT01324518|BG002|Baseline|Placebo|Placebo for ORM-12741: Placebo twice a day
11053907|NCT01324518|BG003|Baseline|Total|Total of all reporting groups
11053908|NCT01324518|FG000|Participant Flow|Low Dose of ORM-12741|ORM-12741: 60mg twice a day
11053909|NCT01324518|FG001|Participant Flow|High Dose of ORM-12741|ORM-12741: 200mg twice a day
11053910|NCT01324518|FG002|Participant Flow|Placebo|Placebo for ORM-12741: Placebo twice a day
11053911|NCT01324518|OG000|Outcome|Low Dose of ORM-12741|ORM-12741: 60mg twice a day
11053912|NCT01324518|OG001|Outcome|High Dose of ORM-12741|ORM-12741: 200mg twice a day
11053913|NCT01324518|OG002|Outcome|Placebo|Placebo for ORM-12741: Placebo twice a day
11053914|NCT01324518|EG000|Reported Event|Low Dose of ORM-12741|ORM-12741: 60mg twice a day
10847065|NCT00281580|EG003|Reported Event|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|
10847066|NCT00281580|EG004|Reported Event|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|
10847067|NCT00281580|EG005|Reported Event|Telmisartan 40 mg (T40)|
11053915|NCT01324518|EG001|Reported Event|High Dose of ORM-12741|ORM-12741: 200mg twice a day
11053916|NCT01324518|EG002|Reported Event|Placebo|Placebo for ORM-12741: Placebo twice a day
11053917|NCT01324570|BG000|Baseline|7 to 11 Years|Children 7 to 11 years of age
11053918|NCT01324570|BG001|Baseline|12 to 16 Years|Children 12 to 16 years of age
11053919|NCT01324570|BG002|Baseline|Total|Total of all reporting groups
11053920|NCT01324570|FG000|Participant Flow|7 to 11 Years|Children 7 to 11 years of age
11053921|NCT01324570|FG001|Participant Flow|12 to 16 Years|Children 12 to 16 years of age
11053922|NCT01324570|OG000|Outcome|7 to 11 Years|Children 7 to 11 years of age
11053923|NCT01324570|OG001|Outcome|12 to 16 Years|Children 12 to 16 years of age
11053924|NCT01324570|OG000|Outcome|Population PK Analysis Set|Children 7 to 16 years of age (reference patient with IBW of 70 kg)
11053925|NCT01324570|OG000|Outcome|12 to 16 Years|Children 12 to 16 years of age
11053926|NCT01324570|EG000|Reported Event|7 to 11 Years|Children 7 to 11 years of age
11053927|NCT01324570|EG001|Reported Event|12 to 16 Years|Children 12 to 16 years of age
11053928|NCT01324622|BG000|Baseline|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
11053929|NCT01324622|BG001|Baseline|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
11053930|NCT01324622|BG002|Baseline|Total|Total of all reporting groups
11053931|NCT01324622|FG000|Participant Flow|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
11053932|NCT01324622|FG001|Participant Flow|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
11053933|NCT01324622|OG000|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
11053934|NCT01324622|OG001|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
11053935|NCT01324622|OG001|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
11053936|NCT01324622|EG000|Reported Event|Laminectomy|Control laminectomy: standard procedure
11053937|NCT01324622|EG001|Reported Event|Laminoplasty|Treatment group Laminoplasty: Utilizing the ARCH Fixation System (Study device)
11053938|NCT01324687|BG000|Baseline|Control|Group without access to telemedicine in the home for acute care issues.
11053939|NCT01324687|BG001|Baseline|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
11053940|NCT01324687|BG002|Baseline|Total|Total of all reporting groups
11053941|NCT01324687|FG000|Participant Flow|Control|Group without access to telemedicine in the home for acute care issues.
11053942|NCT01324687|FG001|Participant Flow|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
11053943|NCT01324687|OG000|Outcome|Control|Group without access to telemedicine in the home for acute care issues.
11053944|NCT01324687|OG001|Outcome|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
11053945|NCT01324687|EG000|Reported Event|Control|Group without access to telemedicine in the home for acute care issues.
11053946|NCT01324687|EG001|Reported Event|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
11053947|NCT01324700|BG000|Baseline|High Severity: Escitalopram|"Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the high severity-escitalopram group had at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral escitalopram at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day."
11053948|NCT01324700|BG001|Baseline|High Severity: Placebo|"Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the high severity-placebo group had at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral placebo (identical in appearance to the active medication) every 2 weeks for 12 total weeks."
11053949|NCT01324700|BG002|Baseline|Low Severity: Escitalopram|"Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the low severity-escitalopram group had at least 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral escitalopram at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day."
11053950|NCT01324700|BG003|Baseline|Low Severity: Placebo|"Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the low severity-placebo group had at least 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral placebo (identical in appearance to the active medication) every 2 weeks for 12 total weeks."
11053951|NCT01324700|BG004|Baseline|Total|Total of all reporting groups
11053952|NCT01324700|FG000|Participant Flow|High Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the high severity group, participants had to have at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received escitalopram (or identical placebo) at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day (or equivalent placebo).
11053953|NCT01324700|FG001|Participant Flow|High Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the high severity group, participants had to have at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received placebo (identical in appearance to the active medication) with follow-up visits every 2 weeks for 12 total weeks.
11053954|NCT01324700|FG002|Participant Flow|Low Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the low severity group, participants had to have fewer than 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of less than 20 (or both). Participants received escitalopram (or identical placebo) at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day (or equivalent placebo).
11053955|NCT01324700|FG003|Participant Flow|Low Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the low severity group, participants had to have fewer than 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of less than 20. Participants received placebo (identical in appearance to the active medication) with follow-up visits every 2 weeks for 12 total weeks.
11053956|NCT01324700|OG000|Outcome|High Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
11053957|NCT01324700|OG001|Outcome|High Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
11053958|NCT01324700|OG002|Outcome|Low Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
11053959|NCT01324700|OG003|Outcome|Low Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
11053960|NCT01324700|EG000|Reported Event|High Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
11053961|NCT01324700|EG001|Reported Event|High Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
11053962|NCT01324700|EG002|Reported Event|Low Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
11053963|NCT01324700|EG003|Reported Event|Low Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
10847068|NCT00281580|EG006|Reported Event|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|
11053964|NCT01324830|BG000|Baseline|Schedule A BI 847325 6 mg (A1)|Schedule A BI 847325 6 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11149323|NCT01870297|OG005|Outcome|Placebo Part B|Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days
11053965|NCT01324830|BG001|Baseline|Schedule A BI 847325 9 mg (A2)|Schedule A BI 847325 9 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053966|NCT01324830|BG002|Baseline|Schedule A BI 847325 13 mg (A3)|Schedule A BI 847325 13 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053967|NCT01324830|BG003|Baseline|Schedule A BI 847325 19 mg (A4)|Schedule A BI 847325 19 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053968|NCT01324830|BG004|Baseline|Schedule A BI 847325 26 mg (A5)|Schedule A BI 847325 26 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053969|NCT01324830|BG005|Baseline|Schedule A BI 847325 33 mg (A6)|Schedule A BI 847325 33 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053970|NCT01324830|BG006|Baseline|Schedule A BI 847325 46 mg (A7)|Schedule A BI 847325 46 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053971|NCT01324830|BG007|Baseline|Schedule A BI 847325 63 mg (A8)|Schedule A BI 847325 63 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053972|NCT01324830|BG008|Baseline|Schedule A BI 847325 86 mg (A9)|Schedule A BI 847325 86 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053973|NCT01324830|BG009|Baseline|Schedule A BI 847325 120 mg (A10)|Schedule A BI 847325 120 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053974|NCT01324830|BG010|Baseline|Schedule A BI 847325 160 mg (A11)|Schedule A BI 847325 160 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053975|NCT01324830|BG011|Baseline|Schedule B BI 847325 6 mg (B1)|Schedule B BI 847325 6 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053976|NCT01324830|BG012|Baseline|Schedule B BI 847325 12 mg (B2)|Schedule B BI 847325 12 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053977|NCT01324830|BG013|Baseline|Schedule B BI 847325 23 mg (B3)|Schedule B BI 847325 23 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053978|NCT01324830|BG014|Baseline|Schedule B BI 847325 46 mg (B4)|Schedule B BI 847325 46 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053979|NCT01324830|BG015|Baseline|Schedule B BI 847325 90 mg (B5)|Schedule B BI 847325 90 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053980|NCT01324830|BG016|Baseline|Schedule B BI 847325 180 mg (B6)|Schedule B BI 847325 180 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053981|NCT01324830|BG017|Baseline|Schedule B BI 847325 130 mg (B7)|Schedule B BI 847325 130 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053982|NCT01324830|BG018|Baseline|Schedule B BI 847325 150 mg (B8)|Schedule B BI 847325 150 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053983|NCT01324830|BG019|Baseline|Total|Total of all reporting groups
11053984|NCT01324830|FG000|Participant Flow|Schedule A BI 847325 6 mg (A1)|Schedule A BI 847325 6 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053985|NCT01324830|FG001|Participant Flow|Schedule A BI 847325 9 mg (A2)|Schedule A BI 847325 9 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053986|NCT01324830|FG002|Participant Flow|Schedule A BI 847325 13 mg (A3)|Schedule A BI 847325 13 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053987|NCT01324830|FG003|Participant Flow|Schedule A BI 847325 19 mg (A4)|Schedule A BI 847325 19 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
10847069|NCT00281580|EG007|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|
10847070|NCT00281580|EG008|Reported Event|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|
10847071|NCT00281580|EG009|Reported Event|Telmisartan 80 mg (T80)|
11053988|NCT01324830|FG004|Participant Flow|Schedule A BI 847325 26 mg (A5)|Schedule A BI 847325 26 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053989|NCT01324830|FG005|Participant Flow|Schedule A BI 847325 33 mg (A6)|Schedule A BI 847325 33 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053990|NCT01324830|FG006|Participant Flow|Schedule A BI 847325 46 mg (A7)|Schedule A BI 847325 46 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053991|NCT01324830|FG007|Participant Flow|Schedule A BI 847325 63 mg (A8)|Schedule A BI 847325 63 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053992|NCT01324830|FG008|Participant Flow|Schedule A BI 847325 86 mg (A9)|Schedule A BI 847325 86 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053993|NCT01324830|FG009|Participant Flow|Schedule A BI 847325 120 mg (A10)|Schedule A BI 847325 120 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053994|NCT01324830|FG010|Participant Flow|Schedule A BI 847325 160 mg (A11)|Schedule A BI 847325 160 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053995|NCT01324830|FG011|Participant Flow|Schedule B BI 847325 6 mg (B1)|Schedule B BI 847325 6 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053996|NCT01324830|FG012|Participant Flow|Schedule B BI 847325 12 mg (B2)|Schedule B BI 847325 12 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053997|NCT01324830|FG013|Participant Flow|Schedule B BI 847325 23 mg (B3)|Schedule B BI 847325 23 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053998|NCT01324830|FG014|Participant Flow|Schedule B BI 847325 46 mg (B4)|Schedule B BI 847325 46 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11053999|NCT01324830|FG015|Participant Flow|Schedule B BI 847325 90 mg (B5)|Schedule B BI 847325 90 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054000|NCT01324830|FG016|Participant Flow|Schedule B BI 847325 180 mg (B6)|Schedule B BI 847325 180 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054001|NCT01324830|FG017|Participant Flow|Schedule B BI 847325 130 mg (B7)|Schedule B BI 847325 130 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054002|NCT01324830|FG018|Participant Flow|Schedule B BI 847325 150 mg (B8)|Schedule B BI 847325 150 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054003|NCT01324830|OG000|Outcome|Schedule A BI 847325 6 mg (A1)|Schedule A BI 847325 6 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054004|NCT01324830|OG001|Outcome|Schedule A BI 847325 9 mg (A2)|Schedule A BI 847325 9 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054005|NCT01324830|OG002|Outcome|Schedule A BI 847325 13 mg (A3)|Schedule A BI 847325 13 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054006|NCT01324830|OG003|Outcome|Schedule A BI 847325 19 mg (A4)|Schedule A BI 847325 19 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054007|NCT01324830|OG004|Outcome|Schedule A BI 847325 26 mg (A5)|Schedule A BI 847325 26 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11149324|NCT01870297|OG006|Outcome|5.0 mg LY3025876 + Liraglutide|Part B:5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
11149325|NCT01870297|EG000|Reported Event|Placebo Part A|Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
11149326|NCT01870297|EG001|Reported Event|0.5 mg LY3025876|Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149327|NCT01870297|EG002|Reported Event|1.5 mg LY3025876|Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11149328|NCT01870297|EG003|Reported Event|5.0 mg LY3025876|Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
11054008|NCT01324830|OG005|Outcome|Schedule A BI 847325 33 mg (A6)|Schedule A BI 847325 33 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054009|NCT01324830|OG006|Outcome|Schedule A BI 847325 46 mg (A7)|Schedule A BI 847325 46 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054010|NCT01324830|OG007|Outcome|Schedule A BI 847325 63 mg (A8)|Schedule A BI 847325 63 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054011|NCT01324830|OG008|Outcome|Schedule A BI 847325 86 mg (A9)|Schedule A BI 847325 86 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054012|NCT01324830|OG009|Outcome|Schedule A BI 847325 120 mg (A10)|Schedule A BI 847325 120 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054013|NCT01324830|OG010|Outcome|Schedule A BI 847325 160 mg (A11)|Schedule A BI 847325 160 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054014|NCT01324830|OG011|Outcome|Schedule B BI 847325 6 mg (B1)|Schedule B BI 847325 6 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054015|NCT01324830|OG012|Outcome|Schedule B BI 847325 12 mg (B2)|Schedule B BI 847325 12 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054016|NCT01324830|OG013|Outcome|Schedule B BI 847325 23 mg (B3)|Schedule B BI 847325 23 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054017|NCT01324830|OG014|Outcome|Schedule B BI 847325 46 mg (B4)|Schedule B BI 847325 46 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054018|NCT01324830|OG015|Outcome|Schedule B BI 847325 90 mg (B5)|Schedule B BI 847325 90 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054019|NCT01324830|OG016|Outcome|Schedule B BI 847325 180 mg (B6)|Schedule B BI 847325 180 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054020|NCT01324830|OG017|Outcome|Schedule B BI 847325 130 mg (B7)|Schedule B BI 847325 130 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054021|NCT01324830|OG018|Outcome|Schedule B BI 847325 150 mg (B8)|Schedule B BI 847325 150 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054022|NCT01324830|OG019|Outcome|Schedule A Total (Total A)|All patients with schedule A. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks.
11054023|NCT01324830|OG020|Outcome|Schedule B Total (Total B)|Schedule B total treated patients. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles.
11054024|NCT01324830|OG021|Outcome|Total Patients|Schedule A and B total patients.
11054025|NCT01324830|EG000|Reported Event|Schedule A BI 847325 6 mg (A1)|Schedule A BI 847325 6 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054026|NCT01324830|EG001|Reported Event|Schedule A BI 847325 9 mg (A2)|Schedule A BI 847325 9 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054027|NCT01324830|EG002|Reported Event|Schedule A BI 847325 13 mg (A3)|Schedule A BI 847325 13 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054028|NCT01324830|EG003|Reported Event|Schedule A BI 847325 19 mg (A4)|Schedule A BI 847325 19 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054029|NCT01324830|EG004|Reported Event|Schedule A BI 847325 26 mg (A5)|Schedule A BI 847325 26 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054030|NCT01324830|EG005|Reported Event|Schedule A BI 847325 33 mg (A6)|Schedule A BI 847325 33 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054031|NCT01324830|EG006|Reported Event|Schedule A BI 847325 46 mg (A7)|Schedule A BI 847325 46 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11149329|NCT01870297|EG004|Reported Event|15 mg LY3025876|Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
10847072|NCT00281580|EG010|Reported Event|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|
11054032|NCT01324830|EG007|Reported Event|Schedule A BI 847325 63 mg (A8)|Schedule A BI 847325 63 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054033|NCT01324830|EG008|Reported Event|Schedule A BI 847325 86 mg (A9)|Schedule A BI 847325 86 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054034|NCT01324830|EG009|Reported Event|Schedule A BI 847325 120 mg (A10)|Schedule A BI 847325 120 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054035|NCT01324830|EG010|Reported Event|Schedule A BI 847325 160 mg (A11)|Schedule A BI 847325 160 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054036|NCT01324830|EG011|Reported Event|Schedule A Total (Total A)|All patients with schedule A. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks.
11054037|NCT01324830|EG012|Reported Event|Schedule B BI 847325 6 mg (B1)|Schedule B BI 847325 6 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054038|NCT01324830|EG013|Reported Event|Schedule B BI 847325 12 mg (B2)|Schedule B BI 847325 12 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054039|NCT01324830|EG014|Reported Event|Schedule B BI 847325 23 mg (B3)|Schedule B BI 847325 23 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054040|NCT01324830|EG015|Reported Event|Schedule B BI 847325 46 mg (B4)|Schedule B BI 847325 46 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054041|NCT01324830|EG016|Reported Event|Schedule B BI 847325 90 mg (B5)|Schedule B BI 847325 90 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054042|NCT01324830|EG017|Reported Event|Schedule B BI 847325 180 mg (B6)|Schedule B BI 847325 180 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054043|NCT01324830|EG018|Reported Event|Schedule B BI 847325 130 mg (B7)|Schedule B BI 847325 130 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054044|NCT01324830|EG019|Reported Event|Schedule B BI 847325 150 mg (B8)|Schedule B BI 847325 150 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water.
11054045|NCT01324830|EG020|Reported Event|Schedule B Total (Total B)|Schedule B total treated patients. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles.
11054046|NCT01324830|EG021|Reported Event|Total Patients|Schedule A and B total patients.
11054047|NCT01324882|BG000|Baseline|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
11054048|NCT01324882|BG001|Baseline|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
11054049|NCT01324882|BG002|Baseline|Total|Total of all reporting groups
11054050|NCT01324882|FG000|Participant Flow|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
11054051|NCT01324882|FG001|Participant Flow|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
11054052|NCT01324882|OG000|Outcome|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
11054053|NCT01324882|OG001|Outcome|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
11054054|NCT01324882|OG000|Outcome|Study Arm|"This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.~Colonoscopy with Olympus Technically Improved Colonoscope: The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope."
11054055|NCT01324882|OG001|Outcome|Control|"This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.~Control with standard colonoscope Olympus CF-H180: Standard colonoscopy using the adult scope, Olympus CF-H180."
11054056|NCT01324882|EG000|Reported Event|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
11054057|NCT01324882|EG001|Reported Event|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
11054058|NCT01324947|BG000|Baseline|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
11054059|NCT01324947|FG000|Participant Flow|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
11054060|NCT01324947|OG000|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
11054061|NCT01324947|OG000|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity~pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity"
11149330|NCT01870297|EG005|Reported Event|Placebo Part B|Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days.
10847073|NCT00281580|EG011|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|
11054062|NCT01324947|OG000|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity~pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity"
11054063|NCT01324947|EG000|Reported Event|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
11054064|NCT01324999|BG000|Baseline|Tadalafil|40 mg daily
11054065|NCT01324999|FG000|Participant Flow|Tadalafil|40 mg daily
11054066|NCT01324999|OG000|Outcome|Tadalafil|40 mg daily
11054067|NCT01324999|EG000|Reported Event|Tadalafil|40 mg daily
11054068|NCT01325181|BG000|Baseline|Low-fluence PDT|
11054069|NCT01325181|BG001|Baseline|Ranibizumab|
11054070|NCT01325181|BG002|Baseline|Total|Total of all reporting groups
11054071|NCT01325181|FG000|Participant Flow|Low-fluence PDT|
11054072|NCT01325181|FG001|Participant Flow|Ranibizumab|
11054073|NCT01325181|OG000|Outcome|Low-fluence PDT|
11054074|NCT01325181|OG001|Outcome|Ranibizumab|
11054075|NCT01325181|EG000|Reported Event|Low-fluence PDT|
11054076|NCT01325181|EG001|Reported Event|Ranibizumab|
11054077|NCT01325207|BG000|Baseline|Cohort 1 - Trastuzumab 10mg IT 2/Week|"Intrathecal Trastuzumab 10 mg IT will be administered in Cohort 1 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054078|NCT01325207|BG001|Baseline|Cohort 2 - Trastuzumab 20mg IT 2/Week|"Intrathecal Trastuzumab 20 mg IT will be administered in Cohort 2 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054079|NCT01325207|BG002|Baseline|Cohort 3- Trastuzumab 40mg IT 2/Week|"Intrathecal Trastuzumab 40 mg IT will be administered in Cohort 3 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054080|NCT01325207|BG003|Baseline|Cohort 4 - Trastuzumab 60mg IT 2/Week|"Intrathecal Trastuzumab 60 mg IT will be administered in Cohort 4 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054081|NCT01325207|BG004|Baseline|Cohort 5 - 80mg IT 2/Week|"Intrathecal Trastuzumab 80 mg IT will be administered in Cohort 5 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054082|NCT01325207|BG005|Baseline|Phase II - Transtuzumab 80mg IT 2/Week|"Intrathecal Trastuzumab 10 mg IT will be administered in phase II portion of the study.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054083|NCT01325207|BG006|Baseline|Total|Total of all reporting groups
11054084|NCT01325207|FG000|Participant Flow|Cohort 1 - Trastuzumab 10mg IT 2/Week|"Intrathecal Trastuzumab 10 mg IT will be administered in Cohort 1 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054085|NCT01325207|FG001|Participant Flow|Cohort 2 - Trastuzumab 20mg IT 2/Week|"Intrathecal Trastuzumab 20 mg IT will be administered in Cohort 2 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054086|NCT01325207|FG002|Participant Flow|Cohort 3- Trastuzumab 40mg IT 2/Week|"Intrathecal Trastuzumab 40 mg IT will be administered in Cohort 3 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054087|NCT01325207|FG003|Participant Flow|Cohort 4 - Trastuzumab 60mg IT 2/Week|"Intrathecal Trastuzumab 60 mg IT will be administered in Cohort 4 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054088|NCT01325207|FG004|Participant Flow|Cohort 5 - 80mg IT 2/Week|"Intrathecal Trastuzumab 80 mg IT will be administered in Cohort 5 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054089|NCT01325207|FG005|Participant Flow|Phase II - Transtuzumab 80mg IT 2/Week|"Intrathecal Trastuzumab 10 mg IT will be administered in phase II portion of the study.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054090|NCT01325207|OG000|Outcome|Cohort 1 - Trastuzumab 10mg IT 2/Week|"Intrathecal Trastuzumab 10 mg IT will be administered in Cohort 1 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054091|NCT01325207|OG001|Outcome|Cohort 2 - Trastuzumab 20mg IT 2/Week|"Intrathecal Trastuzumab 20 mg IT will be administered in Cohort 2 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054092|NCT01325207|OG002|Outcome|Cohort 3- Trastuzumab 40mg IT 2/Week|"Intrathecal Trastuzumab 40 mg IT will be administered in Cohort 3 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054093|NCT01325207|OG003|Outcome|Cohort 4 - Trastuzumab 60mg IT 2/Week|"Intrathecal Trastuzumab 60 mg IT will be administered in Cohort 4 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054094|NCT01325207|OG004|Outcome|Cohort 5 - 80mg IT 2/Week|"Intrathecal Trastuzumab 80 mg IT will be administered in Cohort 5 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054095|NCT01325207|OG000|Outcome|Treatment With Trastuzumab|"Intrathecal Trastuzumab will be administered in a dose escalation design from 10mg up to 80 mg IT.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks.~1 cycle = 28 days"
11054096|NCT01325207|OG001|Outcome|Cohort 5 + Phase II - Intrathecal Trastuzumab- 80 mg|"Intrathecal Trastuzumab will be administered at the MTD determined dose of 80 mg IT.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks.~1 cycle = 28 days"
11054097|NCT01325207|EG000|Reported Event|Cohort 1 - Trastuzumab 10mg IT 2/Week|"Intrathecal Trastuzumab 10 mg IT will be administered in Cohort 1 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054098|NCT01325207|EG001|Reported Event|Cohort 2 - Trastuzumab 20mg IT 2/Week|"Intrathecal Trastuzumab 20 mg IT will be administered in Cohort 2 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054099|NCT01325207|EG002|Reported Event|Cohort 3- Trastuzumab 40mg IT 2/Week|"Intrathecal Trastuzumab 40 mg IT will be administered in Cohort 3 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054100|NCT01325207|EG003|Reported Event|Cohort 4 - Trastuzumab 60mg IT 2/Week|"Intrathecal Trastuzumab 60 mg IT will be administered in Cohort 4 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054101|NCT01325207|EG004|Reported Event|Cohort 5 - 80mg IT 2/Week|"Intrathecal Trastuzumab 80 mg IT will be administered in Cohort 5 of dose escalation.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
10847074|NCT00281580|EG012|Reported Event|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|
10847075|NCT00281580|EG013|Reported Event|Amlodipine 2.5 mg (A2.5)|
10847076|NCT00281580|EG014|Reported Event|Amlodipine 5 mg (A5)|
10847077|NCT00281580|EG015|Reported Event|Amlodipine 10 mg (A10)|
10847078|NCT00281632|BG000|Baseline|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
10847079|NCT00281632|FG000|Participant Flow|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
11054102|NCT01325207|EG005|Reported Event|Phase II - Transtuzumab 80mg IT 2/Week|"Intrathecal Trastuzumab 10 mg IT will be administered in phase II portion of the study.~Trastuzumab: Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks until disease progression or unacceptable toxicity.~1 cycle = 28 days."
11054103|NCT01325311|BG000|Baseline|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11054104|NCT01325311|BG001|Baseline|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11054105|NCT01325311|BG002|Baseline|Total|Total of all reporting groups
11054106|NCT01325311|FG000|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11054107|NCT01325311|FG001|Participant Flow|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11054108|NCT01325311|OG000|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11054109|NCT01325311|OG001|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11054110|NCT01325311|EG000|Reported Event|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11054111|NCT01325311|EG001|Reported Event|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11054112|NCT01325337|BG000|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054113|NCT01325337|BG001|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054114|NCT01325337|BG002|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054115|NCT01325337|BG003|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054116|NCT01325337|BG004|Baseline|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
11054117|NCT01325337|BG005|Baseline|Total|Total of all reporting groups
11054118|NCT01325337|FG000|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054119|NCT01325337|FG001|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054120|NCT01325337|FG002|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054121|NCT01325337|FG003|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054122|NCT01325337|FG004|Participant Flow|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
11054123|NCT01325337|OG000|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054124|NCT01325337|OG001|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054125|NCT01325337|OG002|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054126|NCT01325337|OG003|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054127|NCT01325337|OG004|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
11054128|NCT01325337|EG000|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054129|NCT01325337|EG001|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054130|NCT01325337|EG002|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054131|NCT01325337|EG003|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054132|NCT01325337|EG004|Reported Event|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
11054133|NCT01325350|BG000|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054134|NCT01325350|BG001|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054135|NCT01325350|BG002|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054136|NCT01325350|BG003|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054137|NCT01325350|BG004|Baseline|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
11054138|NCT01325350|BG005|Baseline|Total|Total of all reporting groups
11054139|NCT01325350|FG000|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054140|NCT01325350|FG001|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054141|NCT01325350|FG002|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054142|NCT01325350|FG003|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054143|NCT01325350|FG004|Participant Flow|Minoxidil 2% Solution|Approximately one mL of minoxidil 2% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
11054144|NCT01325350|OG000|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054145|NCT01325350|OG001|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054146|NCT01325350|OG002|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054147|NCT01325350|OG003|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054148|NCT01325350|OG004|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
11054149|NCT01325350|EG000|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054150|NCT01325350|EG001|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054151|NCT01325350|EG002|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054152|NCT01325350|EG003|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
11054153|NCT01325350|EG004|Reported Event|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
11149331|NCT01870297|EG006|Reported Event|Placebo + Liraglutide|Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
11054154|NCT01325428|BG000|Baseline|Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
11054155|NCT01325428|FG000|Participant Flow|Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
11054156|NCT01325428|OG000|Outcome|Part A: Afatinib Once Daily (OD).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~The 95% Confidence Interval is Exact Confidence Interval."
11054157|NCT01325428|OG000|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
11054158|NCT01325428|OG000|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
11054159|NCT01325428|OG000|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
11054160|NCT01325428|OG000|Outcome|Afatinib Once Daily (OD). Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval."
11054161|NCT01325428|EG000|Reported Event|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
11054162|NCT01325428|EG001|Reported Event|Part B: Afatinib+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
10847080|NCT00281632|OG000|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
11054163|NCT01325493|BG000|Baseline|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
11054164|NCT01325493|BG001|Baseline|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
11054165|NCT01325493|BG002|Baseline|Total|Total of all reporting groups
11054166|NCT01325493|FG000|Participant Flow|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
11054167|NCT01325493|FG001|Participant Flow|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
11054168|NCT01325493|OG000|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
11054169|NCT01325493|OG001|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
11054170|NCT01325493|EG000|Reported Event|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
10847081|NCT00281632|OG000|Outcome|Overall Study Arm|
10847082|NCT00281632|OG000|Outcome|Pazopanib 800 mg With Measurable Disease|Participants with measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily
10847083|NCT00281632|OG001|Outcome|Pazopanib 800 mg Without Measurable Disease|Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
11054171|NCT01325493|EG001|Reported Event|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
11054172|NCT01325532|BG000|Baseline|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of on and 16.7msec of off time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the on time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and off time is followed by an opposite negative burst and off time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
11054173|NCT01325532|BG001|Baseline|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device's green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
11054174|NCT01325532|BG002|Baseline|Total|Total of all reporting groups
11054175|NCT01325532|FG000|Participant Flow|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of on and 16.7msec of off time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the on time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and off time is followed by an opposite negative burst and off time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
11054176|NCT01325532|FG001|Participant Flow|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device's green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
11054177|NCT01325532|OG000|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of on and 16.7msec of off time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the on time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and off time is followed by an opposite negative burst and off time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
11054178|NCT01325532|OG001|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device's green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
11054179|NCT01325532|EG000|Reported Event|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of on and 16.7msec of off time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the on time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and off time is followed by an opposite negative burst and off time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
11054180|NCT01325532|EG001|Reported Event|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device's green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
11054181|NCT01325584|BG000|Baseline|Omegaven (Compassionate Use)|"This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.~Omegaven: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month."
11054182|NCT01325584|FG000|Participant Flow|Omegaven (Compassionate Use)|"This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.~Omegaven: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month."
11054183|NCT01325584|OG000|Outcome|Omegaven (Compassionate Use)|"This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.~Omegaven: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month."
11054184|NCT01325584|EG000|Reported Event|Omegaven (Compassionate Use)|"This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.~Omegaven: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month."
11054185|NCT01325623|BG000|Baseline|VNS Therapy (Safety Population)|The safety population consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2.
11054186|NCT01325623|FG000|Participant Flow|Enrolled and Treated Population (Safety Population)|"Consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2. The safety population will be used for all safety analyses. (N=31 subjects).~In version 2 of the AspireSR VNS Therapy System, the TVS diodes (present in version 1) were removed from the electrical circuit to address the accumulation of electrical charge on the sensing node (e.g. generator-can) following delivery of a stimulation."
11054187|NCT01325623|OG000|Outcome|Reported by Investigators|All seizures that occurred during EMU stay and that were identified by investigators.
11054188|NCT01325623|OG001|Outcome|Reported by Triple Review|All seizures that occurred during EMU stay and that were identified by triple review post EMU.
11054189|NCT01325623|OG002|Outcome|Total|Seizures from an ITT subject that were either identified by the investigator during EMU evaluation or during the triple review process of EEG data.
11054190|NCT01325623|OG000|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
11054191|NCT01325623|OG000|Outcome|Potential False Positives|Potential False Positives Based on Heart Rate Increase Associated with Seizures by Randomized SDA Setting (AutoStim Per Hour)
11054192|NCT01325623|OG000|Outcome|Beat Detection Sensitivity By Device IPG|"Cardiac R-Wave Detection Sensitivity Based on Device IPG and ECG Monitor Comparison for 10 second Detection Window. n denotes the total number of patients with available R-R wave data at the visit time point."
10847084|NCT00281632|OG002|Outcome|Pazopanib 800 mg All|All participants administered 800 milligrams (mg) pazopanib administered orally once daily
11054193|NCT01325623|OG000|Outcome|Latency Analysis of Ictal Tachycardia Seizures|"The time difference between SDA detection of the ictal tachycardia seizure and the annotated seizure onset time.~Ictal Tachycardia Seizure is defined as a seizure with an increase from a baseline heart rate to a rate that is greater than 100 bpm and is at least a 55% increase or 35 bpm."
11054194|NCT01325623|OG001|Outcome|Latency Analysis of All Seizure Types|The time difference between SDA seizure detection time and the annotated seizure onset time (ALL seizures).
11054195|NCT01325623|OG000|Outcome|Implant/Recovery|Assessment of Device Usability at Implant and Recovery
11054196|NCT01325623|OG001|Outcome|Day 5 EMU or EMU Discharge|Assessment of Device Usability at EMU (Day 5 or Discharge)
11054197|NCT01325623|OG000|Outcome|Overall Seizure Responder Rate|Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (All seizure types)
11054198|NCT01325623|OG001|Outcome|Partial Seizures|"Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (Partial Seizures)~Partial seizures consist of simple partial, complex partial, complex partial with secondarily generalized seizures."
11054199|NCT01325623|OG000|Outcome|Simple Partial Seizures|NHS3 Scores at Follow-Up Visits
11054200|NCT01325623|OG001|Outcome|Complex Partial Seizures (CPS)|NHS3 Scores at Follow-Up Visits
11054201|NCT01325623|OG002|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-Up Visits
11054202|NCT01325623|OG003|Outcome|Generalized Tonic Clonic Sz|NHS3 Scores at Follow-Up Visits
11054203|NCT01325623|OG000|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
11054204|NCT01325623|OG001|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
11054205|NCT01325623|OG002|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
11054206|NCT01325623|OG003|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
11054207|NCT01325623|OG004|Outcome|SSQ Scores at 24 Months|Change From Baseline at Each Category
11054208|NCT01325623|OG000|Outcome|Proportion of Seizures Ending During Stimulation by Type|EMU seizures that were treated with Automatic Stimulation and ended during the course of the stimulation
11054209|NCT01325623|OG000|Outcome|Historical Seizures|Pre-study EEG recordings
11054210|NCT01325623|OG001|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
11054211|NCT01325623|OG002|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
11054212|NCT01325623|OG000|Outcome|QOLIE-31-P Scores at 3 Months|QOLIE-31-P Scores at Follow-Up Visits
11054213|NCT01325623|OG001|Outcome|QOLIE-31-P Scores at 6 Months|QOLIE-31-P Scores at Follow-Up Visits
11054214|NCT01325623|OG002|Outcome|QOLIE-31-P Scores at 12 Months|QOLIE-31-P Scores at Follow-Up Visits
11054215|NCT01325623|OG003|Outcome|QOLIE-31-P Scores at 18 Months|QOLIE-31-P Scores at Follow-Up Visits
11054216|NCT01325623|OG004|Outcome|QOLIE-31-P Scores at 24 Months|QOLIE-31-P Scores at Follow-Up Visits
11054217|NCT01325623|OG001|Outcome|All EMU Stimulated Seizures|Stimulated Seizures with >= 20% increase in heart rate
11054218|NCT01325623|OG002|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
11054219|NCT01325623|OG003|Outcome|Unstimulated Seizures|Unstimulated seizures with =>20% increase in heart rate.
11054220|NCT01325623|OG000|Outcome|Percentage Change in Heart Rate|Average percentage change in heart rate from pre-stimulation period to heart rate during VNS Therapy Stimulation, following VNS Therapy Stimulation, and following the black-out period.
11054221|NCT01325623|EG000|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the 24-month follow-up visit for all subjects treated/implanted with the AspireSR® VNS Therapy® system. All SAEs are reported in the SAE data table, whereas only the most common AEs (> 5%) are reported in the AE data table.
11054222|NCT01325701|BG000|Baseline|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
11054223|NCT01325701|BG001|Baseline|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
11054224|NCT01325701|BG002|Baseline|Total|Total of all reporting groups
11054225|NCT01325701|FG000|Participant Flow|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
11054226|NCT01325701|FG001|Participant Flow|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
11054227|NCT01325701|OG000|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
11054228|NCT01325701|OG001|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
11054229|NCT01325701|OG000|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis
11054230|NCT01325701|EG000|Reported Event|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
11054231|NCT01325701|EG001|Reported Event|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
11054232|NCT01325714|BG000|Baseline|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
11054233|NCT01325714|BG001|Baseline|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
11054234|NCT01325714|BG002|Baseline|Total|Total of all reporting groups
11054235|NCT01325714|FG000|Participant Flow|Arm 1: PAVeD Intervention|"106 caregivers were randomized to the PAVeD intervention. Five were excluded at baseline because of aggression. 101 caregivers were included in the primary analysis. Dyads assigned to PAVeD received 6 to 8 weekly sessions of 45-minute home visits. PAVeD consists of 4 weekly 45- minute core sessions (Recognizing Pain; Recognizing and Responding to Pain and Distress; Enhancing Communication; Making Daily Activities More Pleasant and Enjoyable) and 2 of 4 elective sessions (Medical Treatments and Talking to Your Doctor, Rest and Relaxation Strategies, Communication Problems and Challenges, and Increasing Pleasant Activities), chosen with the patient and/or caregiver through collaborative goal setting during the first session. The intervention includes didactics, skill-building, discussion, and role-playing guided by a clinician manual and caregiver workbook."
11054236|NCT01325714|FG001|Participant Flow|Arm 2: Enhanced Usual Care|107 caregivers were randomized to Enhanced Usual Care. Three were excluded at baseline because of aggression and two dropped out prior to baseline (one withdrew and one deceased). 102 caregivers were included in primary analysis. Dyads assigned to EU-PC received 8 weekly 15-minute phone calls to query symptom severity, ascertain needs for immediate psychiatric care, and provide minimal support. Primary care physicians of patients assigned to both groups received American Medical Association Continuing Medical Education print material on treating pain in older adults, as well as feedback progress notes documenting the PWD's level of pain and depression at baseline, 3 months, 6 months, and 12 months
10847085|NCT00281632|OG000|Outcome|Pazopanib 800 mg Responders|800 milligrams (mg) pazopanib administered orally once daily Responders
11054237|NCT01325714|OG000|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. N = 101"
11149332|NCT01870388|BG000|Baseline|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
11149333|NCT01870388|BG001|Baseline|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
11054238|NCT01325714|OG001|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.~N = 102"
11054239|NCT01325714|OG000|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
11054240|NCT01325714|OG001|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
11054241|NCT01325714|EG000|Reported Event|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
11054242|NCT01325714|EG001|Reported Event|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
11054243|NCT01325792|BG000|Baseline|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
11054244|NCT01325792|FG000|Participant Flow|Single-staged Open Complex Ventral Incisional Hernia Repair|GORE® BIO-A® Tissue Reinforcement to reinforce the midline fascial closure in single-staged open complex ventral incisional (primary or recurrent anterior abdominal wall) hernia repair.
11054245|NCT01325792|OG000|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
11054246|NCT01325792|EG000|Reported Event|GORE® BIO-A® Tissue Reinforcement|Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
11066773|NCT01393964|OG001|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
11066774|NCT01393964|OG002|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
11066775|NCT01393964|OG000|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
11149334|NCT01870388|BG002|Baseline|Total|Total of all reporting groups
11149335|NCT01870388|FG000|Participant Flow|Baricitinib (Healthy Participants)|Group 1: A single 4-milligram (mg) dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
11149336|NCT01870388|FG001|Participant Flow|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
10847086|NCT00281632|OG001|Outcome|Pazopanib 800 mg Non-Responders|800 milligrams (mg) pazopanib administered orally once daily Non-Responders
11054247|NCT01325870|BG000|Baseline|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
11054248|NCT01325870|BG001|Baseline|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
11054249|NCT01325870|BG002|Baseline|S-CPR|S-CPR: standard manual CPR
11054250|NCT01325870|BG003|Baseline|Total|Total of all reporting groups
11054251|NCT01325870|FG000|Participant Flow|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
11054252|NCT01325870|FG001|Participant Flow|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
11054253|NCT01325870|FG002|Participant Flow|S-CPR|S-CPR: standard manual CPR
11054254|NCT01325870|OG000|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
11054255|NCT01325870|OG001|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
11054256|NCT01325870|OG002|Outcome|S-CPR|S-CPR: standard manual CPR
11054257|NCT01325870|EG000|Reported Event|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
11054258|NCT01325870|EG001|Reported Event|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
11054259|NCT01325870|EG002|Reported Event|S-CPR|S-CPR: standard manual CPR
11054260|NCT01326026|BG000|Baseline|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
11054261|NCT01326026|BG001|Baseline|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
11054262|NCT01326026|BG002|Baseline|Total|Total of all reporting groups
11054263|NCT01326026|FG000|Participant Flow|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
11054264|NCT01326026|FG001|Participant Flow|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
11054265|NCT01326026|OG000|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
11054266|NCT01326026|OG001|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
11054267|NCT01326026|EG000|Reported Event|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
11054268|NCT01326026|EG001|Reported Event|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
11054269|NCT01326481|BG000|Baseline|Single|All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)
11054270|NCT01326481|FG000|Participant Flow|Carotuximab (TRC105) Plus Capecitabine|"All patients received TRC105 + capecitabine~TRC105: IV (7.5 or 10 mg/kg weekly)~Capecitabine: oral (1,000 mg/m2 BID)"
11054271|NCT01326481|OG000|Outcome|Carotuximab (TRC105) Plus Capecitabine|All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)
11054272|NCT01326481|OG000|Outcome|Single|"All patients dosed at 10 mg/kg TRC105 who received TRC105 + capecitabine~TRC105: IV (10 mg/kg weekly)~Capecitabine: oral (1,000 mg/m2 BID)"
10847087|NCT00281632|OG002|Outcome|Pazopanib 800 mg All|800 milligrams (mg) pazopanib administered orally once daily All participants
10847088|NCT00281632|OG000|Outcome|Pazopanib 800 mg|: 800 milligrams (mg) pazopanib administered orally once daily
11054273|NCT01326481|OG000|Outcome|Single|"All patients received TRC105 + capecitabine~TRC105: IV~Capecitabine: oral"
11054274|NCT01326481|EG000|Reported Event|Single|"All patients received TRC105 + capecitabine~TRC105: IV~Capecitabine: oral"
11054275|NCT01326533|BG000|Baseline|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400 mg daily
11054276|NCT01326533|BG001|Baseline|Placebo|Placebo daily
11054277|NCT01326533|BG002|Baseline|Total|Total of all reporting groups
11054278|NCT01326533|FG000|Participant Flow|Hydroxychloroquine|13 weeks of hydroxychloroquine sulfate PO 400 mg/day
11054279|NCT01326533|FG001|Participant Flow|Placebo|13 weeks of placebo PO
11054280|NCT01326533|OG000|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
11054281|NCT01326533|OG001|Outcome|Placebo|PO daily for 13 weeks
11054282|NCT01326533|EG000|Reported Event|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400mg/day
11054283|NCT01326533|EG001|Reported Event|Placebo|Placebo PO
11054284|NCT01326546|BG000|Baseline|Therapeutic HBV Vaccine+Entecavir|"Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.~Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.~entecavir: 0.5mg,per day,oral intake."
11054285|NCT01326546|BG001|Baseline|Placebo+Entecavir|"Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.~entecavir: 0.5mg,per day,oral intake.~placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48."
11054286|NCT01326546|BG002|Baseline|Total|Total of all reporting groups
11054287|NCT01326546|FG000|Participant Flow|Therapeutic HBV Vaccine+Entecavir|"Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.~Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.~entecavir: 0.5mg,per day,oral intake."
11054288|NCT01326546|FG001|Participant Flow|Placebo+Entecavir|"Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.~entecavir: 0.5mg,per day,oral intake.~placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48."
11054289|NCT01326546|OG000|Outcome|Therapeutic HBV Vaccine+Entecavir|"Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.~Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.~entecavir: 0.5mg,per day,oral intake."
11054290|NCT01326546|OG001|Outcome|Placebo+Entecavir|"Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.~entecavir: 0.5mg,per day,oral intake.~placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48."
11054291|NCT01326546|EG000|Reported Event|Therapeutic HBV Vaccine+Entecavir|"Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.~Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.~entecavir: 0.5mg,per day,oral intake."
11054292|NCT01326546|EG001|Reported Event|Placebo+Entecavir|"Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.~entecavir: 0.5mg,per day,oral intake.~placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48."
11054293|NCT01326702|BG000|Baseline|Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg|Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg
11054294|NCT01326702|BG001|Baseline|Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg|Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
11054295|NCT01326702|BG002|Baseline|Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID|Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
11054296|NCT01326702|BG003|Baseline|Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID|Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
11054297|NCT01326702|BG004|Baseline|Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID|Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
11054298|NCT01326702|BG005|Baseline|Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID|Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
11054299|NCT01326702|BG006|Baseline|Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID|Bendamustine 90 mg/m2, ABT-888 400 mg BID
11054300|NCT01326702|BG007|Baseline|Total|Total of all reporting groups
11054301|NCT01326702|FG000|Participant Flow|Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg|Bendamustine 70 mg/m2, ABT-888 50 mg
11054302|NCT01326702|FG001|Participant Flow|Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg|Bendamustine 90 mg/m2, ABT-888 50 mg
11054303|NCT01326702|FG002|Participant Flow|Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID|Bendamustine 90 mg/m2, ABT-888 100 mg BID
11054304|NCT01326702|FG003|Participant Flow|Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID|Bendamustine 90 mg/m2, ABT-888 150 mg BID
11054305|NCT01326702|FG004|Participant Flow|Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID|Bendamustine 90 mg/m2, ABT-888 200 mg BID
11054306|NCT01326702|FG005|Participant Flow|Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID|Bendamustine 90 mg/m2, ABT-888 300 mg BID
11054307|NCT01326702|FG006|Participant Flow|Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID|Bendamustine 90 mg/m2, ABT-888 400 mg BID
11054308|NCT01326702|OG000|Outcome|All Study Participants|All Study Participants
11054309|NCT01326702|OG000|Outcome|Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg|Bendamustine 70 mg/m2, ABT-888 50 mg
11054310|NCT01326702|OG001|Outcome|Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg|Bendamustine 90 mg/m2, ABT-888 50 mg
11054311|NCT01326702|OG002|Outcome|Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID|Bendamustine 90 mg/m2, ABT-888 100 mg BID
11054312|NCT01326702|OG003|Outcome|Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID|Bendamustine 90 mg/m2, ABT-888 150 mg BID
11054313|NCT01326702|OG004|Outcome|Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID|Bendamustine 90 mg/m2, ABT-888 200 mg BID
11054314|NCT01326702|OG005|Outcome|Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID|Bendamustine 90 mg/m2, ABT-888 300 mg BID
11054315|NCT01326702|OG006|Outcome|Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID|Bendamustine 90 mg/m2, ABT-888 400 mg BID
11054316|NCT01326702|OG000|Outcome|Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg|Bendamustine 70 mg/m2, ABT-888 50 mg
11054317|NCT01326702|OG000|Outcome|All Study Participants|Dose Level 7; Bendamustine 90mg/m2, ABT-888 400mg BID
11054318|NCT01326702|EG000|Reported Event|Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg|Bendamustine 70 mg/m2, ABT-888 50 mg
11054319|NCT01326702|EG001|Reported Event|Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg|Bendamustine 90 mg/m2, ABT-888 50 mg
11054320|NCT01326702|EG002|Reported Event|Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID|Bendamustine 90 mg/m2, ABT-888 100 mg BID
11054321|NCT01326702|EG003|Reported Event|Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID|Bendamustine 90 mg/m2, ABT-888 150 mg BID
11054322|NCT01326702|EG004|Reported Event|Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID|Bendamustine 90 mg/m2, ABT-888 200 mg BID
11054323|NCT01326702|EG005|Reported Event|Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID|Bendamustine 90 mg/m2, ABT-888 300 mg BID
11054324|NCT01326702|EG006|Reported Event|Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID|Bendamustine 90 mg/m2, ABT-888 400 mg BID
11054325|NCT01326728|BG000|Baseline|Recipients|Recipient-Subjects will have clinical and research evaluations at baseline and three and six months post-allotransplant, at six-month intervals through three years post-allotransplant, then yearly. Evaluation after relapse treatment response and for new protocol options is permitted.
11054326|NCT01326728|BG001|Baseline|Donors|Donor-Subjects will be enrolled at the time of their clinical evaluation and cell collection for Recipient-Subject therapy. Return evaluation for additional clinical product collection is permitted.
11054327|NCT01326728|BG002|Baseline|Total|Total of all reporting groups
11054328|NCT01326728|FG000|Participant Flow|Recipients|Recipient-Subjects will have clinical and research evaluations at baseline and three and six months post-allotransplant, at six-month intervals through three years post-allotransplant, then yearly. Evaluation after relapse treatment response and for new protocol options is permitted.
11054329|NCT01326728|FG001|Participant Flow|Donors|Donor-Subjects will be enrolled at the time of their clinical evaluation and cell collection for Recipient-Subject therapy. Return evaluation for additional clinical product collection is permitted.
11054330|NCT01326728|OG000|Outcome|Recipients|Recipient-Subjects will have clinical and research evaluations at baseline and three and six months post-allotransplant, at six-month intervals through three years post-allotransplant, then yearly. Evaluation after relapse treatment response and for new protocol options is permitted.
11054331|NCT01326728|EG000|Reported Event|Recipients|Recipient-Subjects will have clinical and research evaluations at baseline and three and six months post-allotransplant, at six-month intervals through three years post-allotransplant, then yearly. Evaluation after relapse treatment response and for new protocol options is permitted.
11054332|NCT01326728|EG001|Reported Event|Donors|Donor-Subjects will be enrolled at the time of their clinical evaluation and cell collection for Recipient-Subject therapy. Return evaluation for additional clinical product collection is permitted.
11054333|NCT01326780|BG000|Baseline|0% Facial Cream|Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
11054334|NCT01326780|BG001|Baseline|1.2% Facial Cream|1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
11054335|NCT01326780|BG002|Baseline|2.4% Facial Cream|2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
11054336|NCT01326780|BG003|Baseline|3.6% Facial Cream|3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
11054337|NCT01326780|BG004|Baseline|Total|Total of all reporting groups
11054338|NCT01326780|FG000|Participant Flow|0% Facial Cream|Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
11054339|NCT01326780|FG001|Participant Flow|1.2% Facial Cream|1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
11054340|NCT01326780|FG002|Participant Flow|2.4% Facial Cream|2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
11054341|NCT01326780|FG003|Participant Flow|3.6% Facial Cream|3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
11054342|NCT01326780|OG000|Outcome|0% Facial Cream|Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
11054343|NCT01326780|OG001|Outcome|1.2% Facial Cream|1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
11054344|NCT01326780|OG002|Outcome|2.4% Facial Cream|2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
11054345|NCT01326780|OG003|Outcome|3.6% Facial Cream|3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
11054346|NCT01326780|EG000|Reported Event|0% Facial Cream|Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
11054347|NCT01326780|EG001|Reported Event|1.2% Facial Cream|1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
11054348|NCT01326780|EG002|Reported Event|2.4% Facial Cream|2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
11054349|NCT01326780|EG003|Reported Event|3.6% Facial Cream|3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
11054350|NCT01326910|BG000|Baseline|19306-127|Experimental Topical cream applied twice daily (or as needed)
11054351|NCT01326910|BG001|Baseline|19306-137|Marketed Topical cream applied twice daily (or as needed)
11054352|NCT01326910|BG002|Baseline|Total|Total of all reporting groups
11054353|NCT01326910|FG000|Participant Flow|19306-127|Experimental Topical cream applied twice daily (or as needed)
11054354|NCT01326910|FG001|Participant Flow|19306-137|Marketed Topical cream applied twice daily (or as needed)
11054355|NCT01326910|OG000|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
11054356|NCT01326910|OG001|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
11054357|NCT01326910|EG000|Reported Event|19306-127|Experimental Topical cream applied twice daily (or as needed)
10847089|NCT00281632|EG000|Reported Event|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
11054358|NCT01326910|EG001|Reported Event|19306-137|Marketed Topical cream applied twice daily (or as needed)
11054359|NCT01326962|BG000|Baseline|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
11054360|NCT01326962|FG000|Participant Flow|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
11054361|NCT01326962|OG000|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
11054362|NCT01326962|EG000|Reported Event|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
11054363|NCT01327053|BG000|Baseline|LDE225 (Sonidegib) 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054364|NCT01327053|BG001|Baseline|LDE225 (Sonidegib) 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054365|NCT01327053|BG002|Baseline|Total|Total of all reporting groups
11054366|NCT01327053|FG000|Participant Flow|LDE225 (Sonidegib) 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054367|NCT01327053|FG001|Participant Flow|LDE225 (Sonidegib) 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054368|NCT01327053|OG000|Outcome|LDE225 200mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054369|NCT01327053|OG001|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054370|NCT01327053|OG002|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054371|NCT01327053|OG003|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054372|NCT01327053|OG000|Outcome|LDE225 200 mg qd|Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054373|NCT01327053|OG001|Outcome|LDE225 800 mg qd|Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054374|NCT01327053|EG000|Reported Event|LDE225 200 mg qd|Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054375|NCT01327053|EG001|Reported Event|LDE225 800 mg qd|Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
11054376|NCT01327157|BG000|Baseline|Control Group-visual Analog Scale (EVA), Dental Cleaning|Dental cleaning and performing the visual analog scale. At first visit was doing Dental cleaning and visual analog scale and after 90 days was doing another visual analog scale.
11054377|NCT01327157|BG001|Baseline|Treatment Group-EVA,Dental Cleaning,Occlusal Adjustment.|Dental cleaning, occlusal adjustment, and visual analog scale and gnathostatic models was doing in the intervention group, at the first visit and after 90 days, visual analog scale, and gnathostatic models.
11054378|NCT01327157|BG002|Baseline|Total|Total of all reporting groups
11054379|NCT01327157|FG000|Participant Flow|Placebo Then Treatment|"Participants recived, Dental cleaning and performing the visual analog scale, durant tree visits.~At first visit was doing Dental cleaning and visual analog scale and after 90 days was doing another visual analog scale.~Participants who recieved Placebo later recieved Treatment as described for The experimental-Occlusal Adjustment Arm."
11054380|NCT01327157|FG001|Participant Flow|Experimental-Occlusal Adjustment|"Participants recived, Dental cleaning, occlusal adjustment, and visual analog scale and gnathostatic models in the first visit.~After three times, consecutively, one visit a month, the intervention was performed. At the first visit and after 90 days, visual analog scale, and gnathostatic models, were performed."
11054381|NCT01327157|OG000|Outcome|Placebo-VAS, Dental Cleaning|Dental cleaning and performing the visual analog scale. At first visit (day 1) was doing Dental cleaning and visual analog scale.
11054382|NCT01327157|OG001|Outcome|Treatment- VAS,Dental Cleaning,Occlusal Adjustment.|Dental cleaning, occlusal adjustment, visual analog scale and gnathostatic models was doing in the intervention group, at the first visit.(day 1). After day 90,the control group passed to treatment group, (day 91)and start the treatment and was done dental cleaning, occlusal adjustment, visual analog scale, and gnatostatic models.
11054383|NCT01327157|OG000|Outcome|First Query|"The dental contacts were evaluated in models and gnathostats demarcated after the points were counted in the models before the treatment.~The models are made in the first query (day 1, and day 91).The models were placed occluding brought with carbon, using the willis compass to keep occluding the posterior base of the model which are aligned with the rear. A model of the teeth was made to measure the occlusion of the teeth (i.e., the amount of contact between maxilla and mandible) and used carbon marks to count the the number of dental contacts."
11054384|NCT01327157|OG001|Outcome|Last Query|"The dental contacts were evaluated in gnathostats models and demarcated , the points were counted in the models after treatment. A model of the teeth was made to measure the occlusion of the teeth (i.e., the amount of contact between the upper and lower mandibles), and used carbon to count the the number of dental contacts.~The models are made on last query,(day 90 to treatment group, and day 180 to controll group turn to be treatment) after four visits on treatment group with one month interval between them.~The models were placed occluding brought with carbon, using the willis compass to keep occluding the posterior base of the model which are aligned with the rear."
11054385|NCT01327157|OG000|Outcome|Placebo-Vas, Dental Cleaning|Dental cleaning and performing the visual analog scale. At first visit (day 1) was doing Dental cleaning and visual analog scale and after 90 days was doing another visual analog scale.
11054386|NCT01327157|OG001|Outcome|Treatment VAS,Dental Cleaning,Occlusal Adjustment.|"Dental cleaning, occlusal adjustment, and visual analog scale and gnathostatic models was doing in the intervention group.~Day 1 and day 90, to treatment group; And day 91 and day 180 to controll group that passed to treatment group."
11054387|NCT01327157|OG000|Outcome|Treatment-VAS Dental Cleaning Occlusal Adjustment|Dental cleanning, occlusal adjustment, and visual analog scale and gnathostatic models was doing in the intervetion group, at the first visit and after 90 days, visual analog scale, and gnathostatic models.
11054388|NCT01327157|EG000|Reported Event|Visual Analog Scale, Dental Cleaning|Dental cleaning and performing the visual analog scale. At first visit was doing Dental cleaning and visual analog scale and after 90 days was doing another visual analog scale.
11054389|NCT01327157|EG001|Reported Event|Visual Analog Scale,Dental Cleaning,Occlusal Adjustment.|"Dental cleaning, occlusal adjustment, and visual analog scale and gnathostatic models was doing in the intervention group, at the first visit.~After 90 days, visual analog scale, and gnathostatic models, was doing again."
11054390|NCT01327274|BG000|Baseline|Treatment Arm|This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the interventional treatment by having outpatient surgery, the Magnetic Mini-Mover procedure, to both place and later explant the experimental Magnimplant or Magnetic Mini-Mover device. After surgery and recovery, all subjects will be fitted for an orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP treatment for 24 months. Patients will be seen in clinic at least monthly until treatment is complete.
11054391|NCT01327274|FG000|Participant Flow|Treatment Arm|"This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) underwent the Magnetic Mini-Mover procedure. The internal magnet, or Magnimplant was implanted on the sternum. After surgery and recovery, all subjects were fitted for an orthotic brace, the Magnatract, which is secured to the patient's chest wall by the attractive force between the coupled internal and external magnets and produces an outward force on the sternum to correct the pectus deformity."
11054392|NCT01327274|OG000|Outcome|Treatment Arm|All patients who underwent the Magnetic Mini-Mover Procedure
11054393|NCT01327274|OG000|Outcome|Treatment Arm|All patients who underwent the Magnetic Mini-Mover Procedure.
11054394|NCT01327274|EG000|Reported Event|Treatment Arm|Magnetic Mini-Mover Procedure (Magnimplant): This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the Magnetic Mini-Mover procedure outpatient surgery to both place and later explant the Magnimplant or Magnetic Mini-Mover device. Patients will be required to wear a custom-fitted orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP treatment for 24 months.
11054395|NCT01327300|BG000|Baseline|All Study Participants|All participants were randomized to receive both mesalamine and placebo.
11054396|NCT01327300|FG000|Participant Flow|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
11054397|NCT01327300|FG001|Participant Flow|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
11054398|NCT01327300|OG000|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks
11054399|NCT01327300|OG001|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks."
11054400|NCT01327300|OG000|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation."
11054401|NCT01327300|OG001|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation"
10847090|NCT00281671|BG000|Baseline|All Study Participants|Because all participants were randomized to receive all interventions, baseline measurements are combined rather that reported by Arm/Group.
11054402|NCT01327300|OG000|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Data is reported as baseline value minus 12 week mean FBDSI value with mesalamine."
11054403|NCT01327300|OG001|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Values reported at the baseline FBDSI score minus the 12 week FBDSI score with placebo."
11054404|NCT01327300|OG000|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks.~The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
11054405|NCT01327300|OG001|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.~The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
11054406|NCT01327300|OG000|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks . Comparison of the change in HADS score after 12 weeks of mesalamine is made to baseline score.
11054407|NCT01327300|OG001|Outcome|Placebo|This group will receive the Placebo for 12 weeks. Comparison of the change in HADS score after 12 weeks of placebo is made to baseline score.
11054408|NCT01327300|OG000|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.
11054409|NCT01327300|OG001|Outcome|Placebo|"This group received the placebo for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.~Two patients in this cross-over study did not provide a 24 hour urine sample needed to obtain the lactulose /mannitol ratio."
11054410|NCT01327300|EG000|Reported Event|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
11054411|NCT01327300|EG001|Reported Event|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
10847091|NCT00281671|FG000|Participant Flow|Nesiritide First, Then Placebo|Patients assigned to this arm received nesiritide 0.015 mcg/kg/hour for 10 hours, followed by a two hour washout period, and then a placebo infusion (0.9 normal saline) for 10 hours
11054412|NCT01327313|BG000|Baseline|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054413|NCT01327313|BG001|Baseline|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054414|NCT01327313|BG002|Baseline|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054415|NCT01327313|BG003|Baseline|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054416|NCT01327313|BG004|Baseline|Total|Total of all reporting groups
11054417|NCT01327313|FG000|Participant Flow|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054418|NCT01327313|FG001|Participant Flow|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054419|NCT01327313|FG002|Participant Flow|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054420|NCT01327313|FG003|Participant Flow|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054421|NCT01327313|OG000|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
10847092|NCT00281671|FG001|Participant Flow|Placebo First, Then Nesiritide|Patients assigned to this arm received a placebo infusion (0.9 normal saline) for 10 hours, followed by a two hour washout period, and then nesiritide 0.015 mcg/kg/hour for 10 hours
11054422|NCT01327313|OG001|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054423|NCT01327313|OG002|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054424|NCT01327313|OG003|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054425|NCT01327313|EG000|Reported Event|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054426|NCT01327313|EG001|Reported Event|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054427|NCT01327313|EG002|Reported Event|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054428|NCT01327313|EG003|Reported Event|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
11054429|NCT01327339|BG000|Baseline|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
11054430|NCT01327339|FG000|Participant Flow|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 milligrams (mg), 1 mg, 2 mg of ropinirole administered once daily. All subjects will be administered of Requip in normal prescription use. Dosage regimen can be changed by the investigator according to the prescribing information.
11054431|NCT01327339|OG000|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
11054432|NCT01327339|EG000|Reported Event|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
11054433|NCT01327482|BG000|Baseline|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
11054434|NCT01327482|FG000|Participant Flow|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
11054435|NCT01327482|OG000|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
11054436|NCT01327482|EG000|Reported Event|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
11054437|NCT01327495|BG000|Baseline|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
11054438|NCT01327495|BG001|Baseline|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054439|NCT01327495|BG002|Baseline|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054440|NCT01327495|BG003|Baseline|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054441|NCT01327495|BG004|Baseline|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054442|NCT01327495|BG005|Baseline|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054443|NCT01327495|BG006|Baseline|Total|Total of all reporting groups
11054444|NCT01327495|FG000|Participant Flow|Arm 1 (Placebo Acyline & Placebo T Gel )|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
11054445|NCT01327495|FG001|Participant Flow|Arm 2 (Acyline & 1.25g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054446|NCT01327495|FG002|Participant Flow|Arm 3 (Acyline & 2.5g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054447|NCT01327495|FG003|Participant Flow|Arm 4 (Acyline & 5g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054448|NCT01327495|FG004|Participant Flow|Arm 5 (Acyline & 10g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054449|NCT01327495|FG005|Participant Flow|Arm 6 (Acyline & 15g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054450|NCT01327495|OG000|Outcome|Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel|Placebo acyline subcutaneous injection every 2 weeks for 12 weeks & daily placebo testosterone (T) gel applied transdermally for 12 weeks.
11054451|NCT01327495|OG001|Outcome|Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.
11054452|NCT01327495|OG002|Outcome|Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.
11054453|NCT01327495|OG003|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.
11054454|NCT01327495|OG004|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.
11054455|NCT01327495|OG005|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
11054456|NCT01327495|OG000|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
11054457|NCT01327495|OG001|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054458|NCT01327495|OG002|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054459|NCT01327495|OG003|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054460|NCT01327495|OG004|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054461|NCT01327495|OG005|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054462|NCT01327495|EG000|Reported Event|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
11054463|NCT01327495|EG001|Reported Event|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054464|NCT01327495|EG002|Reported Event|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054465|NCT01327495|EG003|Reported Event|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054466|NCT01327495|EG004|Reported Event|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054467|NCT01327495|EG005|Reported Event|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
11054468|NCT01327508|BG000|Baseline|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
11054469|NCT01327508|BG001|Baseline|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
11054470|NCT01327508|BG002|Baseline|Total|Total of all reporting groups
11054471|NCT01327508|FG000|Participant Flow|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
11054472|NCT01327508|FG001|Participant Flow|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
11054473|NCT01327508|OG000|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
11054474|NCT01327508|OG001|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
11054475|NCT01327508|EG000|Reported Event|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
11054476|NCT01327508|EG001|Reported Event|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
11054477|NCT01327547|BG000|Baseline|Maraviroc|Participants who received maraviroc in combination with HAART
11054478|NCT01327547|BG001|Baseline|Placebo|Participants who received placebo in combination with HAART
11054479|NCT01327547|BG002|Baseline|Total|Total of all reporting groups
11054480|NCT01327547|FG000|Participant Flow|Maraviroc|Participants who received maraviroc in combination with Highly active antiretroviral therapy (HAART)
11054481|NCT01327547|FG001|Participant Flow|Placebo|Participants who received placebo in combination with HAART
11054482|NCT01327547|OG000|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
11054483|NCT01327547|OG001|Outcome|Placebo|Participants who received placebo in combination with HAART
11054484|NCT01327547|OG000|Outcome|Maraviroc 150 mg|Participants received Maraviroc 150 mg twice a day (BID) in combination with a potent CYP3A4 inhibitor
11054485|NCT01327547|OG001|Outcome|Maraviroc 300 mg|Participants received Maraviroc 300mg BID in the absence of a potent CYP3A4 inhibitor and inducer
11054486|NCT01327547|OG002|Outcome|Maraviroc 600 mg|Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)
11054487|NCT01327547|OG000|Outcome|Aspartate Transaminase (AST)|The p-value of change in AST levels from baseline versus MVC Cavg at Week 48.
11054488|NCT01327547|OG001|Outcome|Alanine Transaminase (ALT)|The p-value of change in ALT levels from baseline versus MVC Cavg at Week 48.
11054489|NCT01327547|OG002|Outcome|Bilirubin (BIL)|The p-value of change in BIL from baseline versus MVC Cavg at Week 48.
11054490|NCT01327547|OG003|Outcome|Enhanced Liver Fibrosis (ELF)|The p-value of change in ELF from baseline versus MVC Cavg at Week 48.
11054491|NCT01327547|OG004|Outcome|Fibroscan (FSCN)|The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.
11054492|NCT01327547|OG005|Outcome|Alkaline Phosphatase (ALK)|The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
11054493|NCT01327547|EG000|Reported Event|Maraviroc|Participants who received maraviroc in combination with HAART
11054494|NCT01327547|EG001|Reported Event|Placebo|Participants who received placebo in combination with HAART
11054495|NCT01327573|BG000|Baseline|Eculizumab|"eculizumab will be given in addition to standard immunosuppression regimen (oral tacrolimus or equivalent, MMF [mycophenolate mofetil~], prednisone)~eculizumab: • Eculizumab Induction 600mg IV every 7 days for 4 doses~Eculizumab 900mg IV 7 days later~Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks"
11054496|NCT01327573|BG001|Baseline|no Additional Therapy|patients in this arm will receive standard immunosuppression regimen (oral tacrolimus or equivalent, MMF, prednisone only, no additional therapy
11054497|NCT01327573|BG002|Baseline|Total|Total of all reporting groups
11054498|NCT01327573|FG000|Participant Flow|Eculizumab|"eculizumab will be given in addition to standard immunosuppression regimen (oral tacrolimus or equivalent, MMF [mycophenolate mofetil~], prednisone)~eculizumab: • Eculizumab Induction 600mg IV every 7 days for 4 doses~Eculizumab 900mg IV 7 days later~Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks"
11054499|NCT01327573|FG001|Participant Flow|no Additional Therapy|patients in this arm will receive standard immunosuppression regimen (oral tacrolimus or equivalent, MMF, prednisone only, no additional therapy
11054500|NCT01327573|OG000|Outcome|Eculizumab|"eculizumab will be given in addition to standard immunosuppression regimen (oral tacrolimus or equivalent, MMF [mycophenolate mofetil~], prednisone)~eculizumab: • Eculizumab Induction 600mg IV every 7 days for 4 doses~Eculizumab 900mg IV 7 days later~Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks"
11054501|NCT01327573|OG001|Outcome|no Additional Therapy|patients in this arm will receive standard immunosuppression regimen (oral tacrolimus or equivalent, MMF, prednisone only, no additional therapy
11054502|NCT01327573|OG000|Outcome|Between Groups Difference|These are the percent change between group differences derived from the Estimated Glomerular Filtration Rate (eGFR) at Months 2,3,4,5,6 outcome.
11054503|NCT01327573|EG000|Reported Event|Eculizumab|"eculizumab will be given in addition to standard immunosuppression regimen (oral tacrolimus or equivalent, MMF [mycophenolate mofetil~], prednisone)~eculizumab: • Eculizumab Induction 600mg IV every 7 days for 4 doses~Eculizumab 900mg IV 7 days later~Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks"
11054504|NCT01327573|EG001|Reported Event|no Additional Therapy|patients in this arm will receive standard immunosuppression regimen (oral tacrolimus or equivalent, MMF, prednisone only, no additional therapy
11054505|NCT01327599|BG000|Baseline|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
11054506|NCT01327599|FG000|Participant Flow|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
11054507|NCT01327599|OG000|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
11054508|NCT01327599|EG000|Reported Event|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
11054509|NCT01327612|BG000|Baseline|20050118: Ganitumab 20 mg/kg|Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
11054510|NCT01327612|BG001|Baseline|20050171: Conatumumab 0.45 mg/kg|Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
11054511|NCT01327612|BG002|Baseline|20060295: Conatumumab 3 mg/kg|Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
11054512|NCT01327612|BG003|Baseline|20060340: Conatumumab 5 mg/kg|Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
11054513|NCT01327612|BG004|Baseline|20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab|Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
11054514|NCT01327612|BG005|Baseline|20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab|Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
11054515|NCT01327612|BG006|Baseline|20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg|Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
11054516|NCT01327612|BG007|Baseline|Total|Total of all reporting groups
11054517|NCT01327612|FG000|Participant Flow|20050118: Ganitumab 20 mg/kg|Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
11054518|NCT01327612|FG001|Participant Flow|20050171: Conatumumab 0.45 mg/kg|Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
11054519|NCT01327612|FG002|Participant Flow|20060295: Conatumumab 3 mg/kg|Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
11054520|NCT01327612|FG003|Participant Flow|20060340: Conatumumab 5 mg/kg|Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
11054521|NCT01327612|FG004|Participant Flow|20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab|Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 (mFOLFOX6) chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
11054522|NCT01327612|FG005|Participant Flow|20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab|Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
11054523|NCT01327612|FG006|Participant Flow|20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg|Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
11054524|NCT01327612|OG000|Outcome|20050118: Ganitumab 20 mg/kg|Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
11054525|NCT01327612|OG001|Outcome|20050171: Conatumumab 0.45 mg/kg|Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
11054526|NCT01327612|OG002|Outcome|20060295: Conatumumab 3 mg/kg|Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
11054527|NCT01327612|OG003|Outcome|20060340: Conatumumab 5 mg/kg|Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
11054528|NCT01327612|OG004|Outcome|20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab|Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
11054529|NCT01327612|OG005|Outcome|20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab|Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
11054530|NCT01327612|OG006|Outcome|20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg|Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
11054531|NCT01327612|OG006|Outcome|20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg|Conatumumab 15 mg/kg and ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
11054532|NCT01327612|EG000|Reported Event|20050118: Ganitumab 20 mg/kg|Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
11054533|NCT01327612|EG001|Reported Event|20050171: Conatumumab 0.45 mg/kg|Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
11054534|NCT01327612|EG002|Reported Event|20060295: Conatumumab 3 mg/kg|Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
11054535|NCT01327612|EG003|Reported Event|20060340: Conatumumab 5 mg/kg|Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
11054536|NCT01327612|EG004|Reported Event|20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab|Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
11054537|NCT01327612|EG005|Reported Event|20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab|Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
11054538|NCT01327612|EG006|Reported Event|20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg|Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
11054539|NCT01327651|BG000|Baseline|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054540|NCT01327651|BG001|Baseline|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054541|NCT01327651|BG002|Baseline|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054542|NCT01327651|BG003|Baseline|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054543|NCT01327651|BG004|Baseline|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054544|NCT01327651|BG005|Baseline|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054545|NCT01327651|BG006|Baseline|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054546|NCT01327651|BG007|Baseline|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054547|NCT01327651|BG008|Baseline|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054548|NCT01327651|BG009|Baseline|Total|Total of all reporting groups
11054549|NCT01327651|FG000|Participant Flow|Daily Dosing, Cape Town|Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
11054550|NCT01327651|FG001|Participant Flow|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054551|NCT01327651|FG002|Participant Flow|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054552|NCT01327651|FG003|Participant Flow|Daily Dosing, Bangkok|Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
11054553|NCT01327651|FG004|Participant Flow|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors"
11054554|NCT01327651|FG005|Participant Flow|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054555|NCT01327651|FG006|Participant Flow|Daily Dosing, Harlem|Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
11054556|NCT01327651|FG007|Participant Flow|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054557|NCT01327651|FG008|Participant Flow|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054558|NCT01327651|OG000|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054559|NCT01327651|OG001|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054560|NCT01327651|OG002|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054561|NCT01327651|OG003|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054562|NCT01327651|OG004|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054563|NCT01327651|OG005|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054564|NCT01327651|OG006|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054565|NCT01327651|OG007|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054566|NCT01327651|OG008|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054567|NCT01327651|OG000|Outcome|Cape Town, South Africa|The University of Cape Town in Cape Town is the IRB of record for the Cape Town site
11054568|NCT01327651|OG001|Outcome|Bangkok, Thailand|The Institutional Review Board, Human Research Protection Office, US Centers for Disease Control and Prevention and the Ethical Review Committee for Research in Human Subjects, Department of Medical Sciences, Ministry of Public Health, Thailand are the IRBs of record for the Bangkok site
11054569|NCT01327651|OG002|Outcome|Harlem, United States|Columbia University Medical Center Institutional Review Board in New York is the IRB of record for the New York site.
11054570|NCT01327651|OG000|Outcome|Daily Dosing, Cape Town|Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
11054571|NCT01327651|OG003|Outcome|Daily Dosing, Bangkok|Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
11054572|NCT01327651|OG004|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors"
11054573|NCT01327651|OG006|Outcome|Daily Dosing, Harlem|Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
11054574|NCT01327651|OG000|Outcome|Cape Town, South Africa, Seroconverted Participant #1|#1 seroconverted participants in Cape Town, South Africa, not randomized
11054575|NCT01327651|OG001|Outcome|Cape Town, South Africa, Seroconverted Participant #2|#2 seroconverted participants in Cape Town, South Africa, not randomized
11054576|NCT01327651|OG002|Outcome|Cape Town, South Africa, Seroconverted Participant #3|#3 seroconverted participants in Cape Town, South Africa, not randomized
11054577|NCT01327651|OG003|Outcome|Cape Town, South Africa, Seroconverted Participant #4|#4 seroconverted participants in Cape Town, South Africa, daily arm
11054578|NCT01327651|OG004|Outcome|Cape Town, South Africa, Seroconverted Participant #5|#5 seroconverted participants in Cape Town, South Africa, time-driven arm
11054579|NCT01327651|OG005|Outcome|Cape Town, South Africa, Seroconverted Participant #6|#6 seroconverted participants in Cape Town, South Africa, time-driven arm
11054580|NCT01327651|OG006|Outcome|Cape Town, South Africa, Seroconverted Participant #7|#7 seroconverted participants in Cape Town, South Africa, event-driven arm
11054581|NCT01327651|OG007|Outcome|Cape Town, South Africa, Seroconverted Participant #8|#8 seroconverted participants in Cape Town, South Africa, event-driven arm
11054582|NCT01327651|OG008|Outcome|Bangkok, Thailand, Seroconverted Participant #1|#1 seroconverted participants in Bangkok, Thailand, not randomized
11054583|NCT01327651|OG009|Outcome|Bangkok, Thailand, Seroconverted Participant #2|#2 seroconverted participants in Bangkok, Thailand, not randomized
11054584|NCT01327651|OG010|Outcome|Harlem, United States, Seroconverted Participant #1|#1 seroconverted participants in Harlem, United States, not randomized
11054585|NCT01327651|OG011|Outcome|Harlem, United States, Seroconverted Participant #2|#2 seroconverted participants in Harlem, United States, daily arm
11054586|NCT01327651|EG000|Reported Event|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054587|NCT01327651|EG001|Reported Event|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054588|NCT01327651|EG002|Reported Event|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054589|NCT01327651|EG003|Reported Event|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054590|NCT01327651|EG004|Reported Event|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054591|NCT01327651|EG005|Reported Event|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054592|NCT01327651|EG006|Reported Event|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054593|NCT01327651|EG007|Reported Event|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054594|NCT01327651|EG008|Reported Event|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
11054595|NCT01327677|BG000|Baseline|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
10847093|NCT00281671|OG000|Outcome|Placebo|"In this crossover pilot study, patients were randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.~For this arm, the data reflect the urine output during the last 5 hours of the 0.9 normal saline placebo infusion for all 9 patients."
11054596|NCT01327677|BG001|Baseline|IVPCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
11054597|NCT01327677|BG002|Baseline|Total|Total of all reporting groups
11054598|NCT01327677|FG000|Participant Flow|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
11054599|NCT01327677|FG001|Participant Flow|PCA Fentanyl|"A patient can self-administer fentanyl intravenously using a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
11054600|NCT01327677|OG000|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
11054601|NCT01327677|OG001|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
11054602|NCT01327677|OG000|Outcome|(Pro re Nata) PRN Fentanyl|"A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
11054603|NCT01327677|OG001|Outcome|Intravenous Patient-controlled Analgesia (IVPCA) Fentanyl|"Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
11054604|NCT01327677|EG000|Reported Event|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
11054605|NCT01327677|EG001|Reported Event|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
11054606|NCT01327703|BG000|Baseline|Entire Study Population|Includes randomized participants who received Panzytrat® 25,000 first and Kreon® 25,000 first.
11054607|NCT01327703|FG000|Participant Flow|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
11054608|NCT01327703|FG001|Participant Flow|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
11054609|NCT01327703|OG000|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
11054610|NCT01327703|OG001|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
11149337|NCT01870388|OG000|Outcome|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with normal hepatic function.
10847094|NCT00281671|OG001|Outcome|Nesiritide|"In this crossover pilot study, patients are randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.~For this arm, the data reflect the urine output during the last 5 hours of the nesiritide 0.015 mcg/kg/hour infusion for all 9 patients."
11054611|NCT01327703|OG000|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
11054612|NCT01327703|OG001|Outcome|Kreon®, First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
11054613|NCT01327703|OG001|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
11054614|NCT01327703|EG000|Reported Event|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
11054615|NCT01327703|EG001|Reported Event|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
11054616|NCT01327846|BG000|Baseline|Group I|Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054617|NCT01327846|BG001|Baseline|Group II|Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054618|NCT01327846|BG002|Baseline|Group III|Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054619|NCT01327846|BG003|Baseline|Group IV|Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054620|NCT01327846|BG004|Baseline|Total|Total of all reporting groups
11054621|NCT01327846|FG000|Participant Flow|Group I|Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054622|NCT01327846|FG001|Participant Flow|Group II|Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054623|NCT01327846|FG002|Participant Flow|Group III|Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054624|NCT01327846|FG003|Participant Flow|Group IV|Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054625|NCT01327846|OG000|Outcome|Group I|Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054626|NCT01327846|OG001|Outcome|Group II|Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054627|NCT01327846|OG002|Outcome|Group III|Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054628|NCT01327846|OG003|Outcome|Group IV|Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054629|NCT01327846|EG000|Reported Event|Group I|Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054630|NCT01327846|EG001|Reported Event|Group II|Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054631|NCT01327846|EG002|Reported Event|Group III|Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
11054632|NCT01327846|EG003|Reported Event|Group IV|Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
10849054|NCT00293423|FG001|Participant Flow|Phase 2: Vaccine|Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
11054633|NCT01327846|EG004|Reported Event|Group V|Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy.
11054634|NCT01327885|BG000|Baseline|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
11054635|NCT01327885|BG001|Baseline|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
11054636|NCT01327885|BG002|Baseline|Total|Total of all reporting groups
11054637|NCT01327885|FG000|Participant Flow|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 milligram per square meter (mg/m^2) was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
11054638|NCT01327885|FG001|Participant Flow|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
11349032|NCT04131517|EG001|Reported Event|Part 1 Oral Contraceptive Alone (SS)|After OC intake on Day 34 through Day 41 at Sequence A and OC intake on Day 1 through Day 18 (prior to PSL intake) at Sequence B attributed to OC Alone Treatment Period. Participants formed the SS.
11054639|NCT01327885|OG000|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
11054640|NCT01327885|OG001|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
11054641|NCT01327885|OG001|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
11054642|NCT01327885|EG000|Reported Event|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
11054643|NCT01327885|EG001|Reported Event|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
11054644|NCT01327963|BG000|Baseline|Transoral Incisionless Fundoplication|"Intervention: Transoral Incisionless Fundoplication: TIF 2.0 technique iteration.~With patient in general anesthesia. The EsophyX device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.~Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) prolene fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized TIF2.0 protocol."
11054645|NCT01327963|FG000|Participant Flow|Transoral Incisionless Fundoplication|"Intervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0).~With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro-esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the Gastroesophageal Junction (GEJ) below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.~Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized transoral incisionless fundoplication 2.0 technique iteration (TIF2.0) protocol."
11054646|NCT01327963|OG000|Outcome|Transoral Incisionless Fundoplication|"Intervention: Transoral Incisionless Fundoplication: TIF 2.0 technique iteration.~With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.~Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless fundoplication 2.0 technique iteration (TIF2.0) protocol."
11054647|NCT01327963|OG000|Outcome|Transoral Incisionless Fundoplication|"Intervention: Transoral Incisionless Fundoplication 2.0 iteration (TIF 2.0). With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.~Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized TIF2.0 protocol."
11349033|NCT04131517|EG002|Reported Event|Part 1 PSL Alone (SS)|First intake of PSL through Day 13 (prior to OC intake) at Sequence A and PSL intake on Day 18 through Day 30 (prior to OC intake) at Sequence B attributed to PSL Alone Treatment Period. Participants formed the SS.
11054648|NCT01327963|OG000|Outcome|Transoral Incisionless Fundoplication|"Intervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0).~With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.~Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized TIF2.0 protocol."
11054649|NCT01327963|EG000|Reported Event|Transoral Incisionless Fundoplication|"Intervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0).~With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro-esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.~Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized TIF2.0 protocol."
11054650|NCT01327976|BG000|Baseline|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
11054651|NCT01327976|BG001|Baseline|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
11054652|NCT01327976|BG002|Baseline|Total|Total of all reporting groups
11054653|NCT01327976|FG000|Participant Flow|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
11054654|NCT01327976|FG001|Participant Flow|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
11054655|NCT01327976|OG000|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
11054656|NCT01327976|OG001|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
11054657|NCT01327976|OG000|Outcome|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy"
11054658|NCT01327976|OG001|Outcome|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBlocTherapy"
11054659|NCT01327976|EG000|Reported Event|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBlocTherapy."
11054660|NCT01327976|EG001|Reported Event|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
11054661|NCT01327989|BG000|Baseline|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
11054662|NCT01327989|FG000|Participant Flow|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
11054663|NCT01327989|OG000|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
11054664|NCT01327989|EG000|Reported Event|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
11054665|NCT01328002|BG000|Baseline|Open-Label Milnacipran|Maximum tolerated dose (50, 75, or 100 mg/day tablets) determined during the open label treatment phase. Oral administration, twice daily dosing
11054666|NCT01328002|FG000|Participant Flow|Milnacipran|Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open-label phase of the study. Oral administration, twice daily dosing
11349034|NCT04128293|BG000|Baseline|Sequence 1 - Treatment ABCD|Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 4. Treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
11054667|NCT01328002|FG001|Participant Flow|Placebo|
11054668|NCT01328002|OG000|Outcome|Placebo|Dose matched placebo, oral administration, twice daily dosing
11054669|NCT01328002|OG001|Outcome|Milnacipran|Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open-label phase of the study. Oral administration, twice daily dosing
11054670|NCT01328002|EG000|Reported Event|Milnacipran - Open-Label Treatment Period|Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during a four-week dose escalation period, and then continued at the maximum tolerated dose for an additional four weeks. Oral administration, twice daily dosing
11054671|NCT01328002|EG001|Reported Event|Placebo - Double Blind-Treatment|Dose matched placebo, oral administration, twice daily dosing
11054672|NCT01328002|EG002|Reported Event|Milnacipran - Double-Blind Treatment Period|Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open-label phase of the study. Oral administration, twice daily dosing
11054673|NCT01328041|BG000|Baseline|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
11054674|NCT01328041|FG000|Participant Flow|Dolutegravir 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice a day (BID).
11054675|NCT01328041|OG000|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
11054676|NCT01328041|EG000|Reported Event|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
11054677|NCT01328054|BG000|Baseline|Placebo and Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
11054678|NCT01328054|FG000|Participant Flow|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
11054679|NCT01328054|FG001|Participant Flow|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 milligrams (mg) (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
11054680|NCT01328054|OG000|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
11054681|NCT01328054|OG001|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
11054682|NCT01328054|OG001|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
11054683|NCT01328054|OG000|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
11054684|NCT01328054|OG000|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
11054685|NCT01328054|OG000|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
11054686|NCT01328054|OG000|Outcome|Placebo/ Lapatinib|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
11054687|NCT01328054|OG000|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
11054688|NCT01328054|EG000|Reported Event|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
11054689|NCT01328054|EG001|Reported Event|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
11054690|NCT01328080|BG000|Baseline|Targeted UV-B|
11054691|NCT01328080|FG000|Participant Flow|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
11054692|NCT01328080|OG000|Outcome|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
11054693|NCT01328080|EG000|Reported Event|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
11054694|NCT01328158|BG000|Baseline|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
11054695|NCT01328158|FG000|Participant Flow|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
11054696|NCT01328158|OG000|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
11054697|NCT01328158|OG000|Outcome|Lopinavir/Ritonavir: Baseline CDC Category A|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
11054698|NCT01328158|OG001|Outcome|Lopinavir/Ritonavir: Baseline CDC Category C|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
11054699|NCT01328158|OG002|Outcome|Lopinavir/Ritonavir: Baseline CDC Category Unknown|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
11054700|NCT01328158|EG000|Reported Event|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
11054701|NCT01328184|BG000|Baseline|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
11054702|NCT01328184|FG000|Participant Flow|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
11054703|NCT01328184|OG000|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
11054704|NCT01328184|OG001|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
11054705|NCT01328184|EG000|Reported Event|Microgynon|One tablet of Microgynon once daily for 14 days.
11054706|NCT01328184|EG001|Reported Event|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
11054707|NCT01328249|BG000|Baseline|Cohort 1: Eribulin Mesylate With Filgrastim as Needed|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.
11054708|NCT01328249|BG001|Baseline|Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
11054709|NCT01328249|BG002|Baseline|Total|Total of all reporting groups
11054710|NCT01328249|FG000|Participant Flow|Cohort 1: Eribulin Mesylate With Filgrastim as Needed|Participants initially received doxorubicin (60 milligram per square meter [mg/m^2]) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.
11054711|NCT01328249|FG001|Participant Flow|Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
11054712|NCT01328249|OG000|Outcome|Cohort 1: Eribulin Mesylate With Filgrastim as Needed|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.
11054713|NCT01328249|OG001|Outcome|Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
11054714|NCT01328249|OG000|Outcome|Cohort 1: Eribulin Mesylate With Filgrastim as Needed|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.
11054715|NCT01328249|OG001|Outcome|Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
11054716|NCT01328249|EG000|Reported Event|Cohort 1: Eribulin Mesylate With Filgrastim as Needed|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.
11149338|NCT01870388|OG001|Outcome|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with moderate hepatic impairment as classified by Child-Pugh B.
11149339|NCT01870388|OG000|Outcome|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
11054717|NCT01328249|EG001|Reported Event|Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim|Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
11054718|NCT01328366|BG000|Baseline|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
11054719|NCT01328366|FG000|Participant Flow|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
11054720|NCT01328366|OG000|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
11054721|NCT01328366|EG000|Reported Event|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
11054722|NCT01328379|BG000|Baseline|Placebo|placebo, twice daily
11054723|NCT01328379|BG001|Baseline|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
11054724|NCT01328379|BG002|Baseline|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
11054725|NCT01328379|BG003|Baseline|Total|Total of all reporting groups
11054726|NCT01328379|FG000|Participant Flow|Placebo|placebo, twice daily
11054727|NCT01328379|FG001|Participant Flow|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
11054728|NCT01328379|FG002|Participant Flow|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
11054729|NCT01328379|OG000|Outcome|Placebo|placebo, twice daily
11054730|NCT01328379|OG001|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
11054731|NCT01328379|OG002|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
11054732|NCT01328379|EG000|Reported Event|Placebo|placebo, twice daily
11054733|NCT01328379|EG001|Reported Event|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
11054734|NCT01328379|EG002|Reported Event|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
11054735|NCT01328405|BG000|Baseline|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
11054736|NCT01328405|BG001|Baseline|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
11054737|NCT01328405|BG002|Baseline|Total|Total of all reporting groups
11054738|NCT01328405|FG000|Participant Flow|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
11054739|NCT01328405|FG001|Participant Flow|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
11054740|NCT01328405|OG000|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
11054741|NCT01328405|OG001|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
11054742|NCT01328405|EG000|Reported Event|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
11054743|NCT01328405|EG001|Reported Event|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
11054744|NCT01328431|BG000|Baseline|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
11054745|NCT01328431|BG001|Baseline|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
11054746|NCT01328431|BG002|Baseline|Total|Total of all reporting groups
11054747|NCT01328431|FG000|Participant Flow|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
11054748|NCT01328431|FG001|Participant Flow|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
11054749|NCT01328431|OG000|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
11149340|NCT01870388|OG001|Outcome|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
11149341|NCT01870388|EG000|Reported Event|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
11054750|NCT01328431|OG001|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
11054751|NCT01328431|EG000|Reported Event|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
11054752|NCT01328431|EG001|Reported Event|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
11054753|NCT01328444|BG000|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
11054754|NCT01328444|FG000|Participant Flow|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
11054755|NCT01328444|FG001|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
11054756|NCT01328444|FG002|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11054757|NCT01328444|FG003|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
11054758|NCT01328444|FG004|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
11054759|NCT01328444|FG005|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
11054760|NCT01328444|OG000|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
11054761|NCT01328444|OG001|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
11054762|NCT01328444|OG002|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11054763|NCT01328444|OG003|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
11054764|NCT01328444|OG004|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
11054765|NCT01328444|OG005|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
11054766|NCT01328444|EG000|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
11054767|NCT01328444|EG001|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
11054768|NCT01328444|EG002|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11054769|NCT01328444|EG003|Reported Event|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
11054770|NCT01328444|EG004|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
11054771|NCT01328444|EG005|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
11054772|NCT01328496|BG000|Baseline|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054773|NCT01328496|BG001|Baseline|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054774|NCT01328496|BG002|Baseline|Total|Total of all reporting groups
11054775|NCT01328496|FG000|Participant Flow|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054776|NCT01328496|FG001|Participant Flow|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054777|NCT01328496|OG000|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054778|NCT01328496|OG000|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054779|NCT01328496|OG000|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observationalal arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054780|NCT01328496|OG001|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054781|NCT01328496|OG001|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054782|NCT01328496|EG000|Reported Event|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11054783|NCT01328496|EG001|Reported Event|Observation Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
11149342|NCT01870388|EG001|Reported Event|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
11054784|NCT01328535|BG000|Baseline|Treatment (Individualized Chemotherapy)|Patients with an established biorhythm receive TMZ PO on recommended day for 5 days. Treatment repeats every 21-42 days until disease progression or unacceptable toxicity. Patients without an established biorhythm receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11054785|NCT01328535|FG000|Participant Flow|Treatment (Individualized Chemotherapy)|Patients with an established biorhythm receive TMZ PO on recommended day for 5 days. Treatment repeats every 21-42 days until disease progression or unacceptable toxicity. Patients without an established biorhythm receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11054786|NCT01328535|OG000|Outcome|Treatment (Timed Individualized Chemotherapy)|Patients with an established biorhythm receive timed TMZ PO on recommended day for 5 days. Treatment repeats every 21-42 days until disease progression or unacceptable toxicity. Patients without an established biorhythm receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11054787|NCT01328535|OG001|Outcome|Treatment (Untimed Individualized Chemotherapy)|Patients with an established biorhythm receive untimed TMZ PO on recommended day for 5 days. Treatment repeats every 21-42 days until disease progression or unacceptable toxicity. Patients without an established biorhythm receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11054788|NCT01328535|OG000|Outcome|Treatment (Individualized Chemotherapy)|Patients with an established biorhythm receive TMZ PO on recommended day for 5 days. Treatment repeats every 21-42 days until disease progression or unacceptable toxicity. Patients without an established biorhythm receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11054789|NCT01328535|EG000|Reported Event|Treatment (Individualized Chemotherapy)|Patients with an established biorhythm receive TMZ PO on recommended day for 5 days. Treatment repeats every 21-42 days until disease progression or unacceptable toxicity. Patients without an established biorhythm receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity.
11054790|NCT01328548|BG000|Baseline|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
11054791|NCT01328548|BG001|Baseline|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
11054792|NCT01328548|BG002|Baseline|Total|Total of all reporting groups
11054793|NCT01328548|FG000|Participant Flow|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
11054794|NCT01328548|FG001|Participant Flow|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
11054795|NCT01328548|OG000|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
11054796|NCT01328548|OG001|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
11054797|NCT01328548|EG000|Reported Event|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
11054798|NCT01328548|EG001|Reported Event|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
11054799|NCT01328574|BG000|Baseline|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
11054800|NCT01328574|FG000|Participant Flow|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
11054801|NCT01328574|OG000|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
11054802|NCT01328574|OG000|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - All Grades|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously~Adverse events grades 1-4 (mild, moderate, severe and life threatening)."
11054803|NCT01328574|OG001|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events."
11054804|NCT01328574|OG002|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events."
11054805|NCT01328574|OG003|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events."
11054806|NCT01328574|OG004|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events."
11054807|NCT01328574|EG000|Reported Event|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
11054808|NCT01328717|BG000|Baseline|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
11054809|NCT01328717|FG000|Participant Flow|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
11054810|NCT01328717|OG000|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
11054811|NCT01328717|EG000|Reported Event|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
11054812|NCT01328743|BG000|Baseline|Treatment as Usual|Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking.
11054813|NCT01328743|BG001|Baseline|Brief Alcohol Intervention|"Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls~Brief alcohol intervention: 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking"
11054814|NCT01328743|BG002|Baseline|Total|Total of all reporting groups
11054815|NCT01328743|FG000|Participant Flow|Treatment as Usual|Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking.
11054816|NCT01328743|FG001|Participant Flow|Brief Alcohol Intervention|"Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls~Brief alcohol intervention: 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking"
11054817|NCT01328743|OG000|Outcome|Treatment as Usual|Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking.
11054818|NCT01328743|OG001|Outcome|Brief Alcohol Intervention|"Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls~Brief alcohol intervention: 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking"
11054819|NCT01328743|EG000|Reported Event|Treatment as Usual|Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking.
11054820|NCT01328743|EG001|Reported Event|Brief Alcohol Intervention|"Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls~Brief alcohol intervention: 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking"
11054821|NCT01328756|BG000|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
11054822|NCT01328756|FG000|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period. At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement [CGI-I]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period.
11054823|NCT01328756|OG000|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
11054824|NCT01328756|EG000|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.
11054825|NCT01328769|BG000|Baseline|Febuxostat|80mg daily
11054826|NCT01328769|BG001|Baseline|Placebo|Matching placebo dose 80mg once daily
11054827|NCT01328769|BG002|Baseline|Total|Total of all reporting groups
11054828|NCT01328769|FG000|Participant Flow|Febuxostat|80mg once daily
11054829|NCT01328769|FG001|Participant Flow|Placebo|Matching placebo dose 80mg once daily
11054830|NCT01328769|OG000|Outcome|Febuxostat|80mg daily
11054831|NCT01328769|OG001|Outcome|Placebo|Matching placebo dose 80mg once daily
11054832|NCT01328769|EG000|Reported Event|Febuxostat|
11054833|NCT01328769|EG001|Reported Event|Placebo|
11054834|NCT01328782|BG000|Baseline|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
11054835|NCT01328782|BG001|Baseline|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
11054836|NCT01328782|BG002|Baseline|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
11054837|NCT01328782|BG003|Baseline|Total|Total of all reporting groups
11054838|NCT01328782|FG000|Participant Flow|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
11054839|NCT01328782|FG001|Participant Flow|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
11054840|NCT01328782|FG002|Participant Flow|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
11054841|NCT01328782|OG000|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
11054842|NCT01328782|OG001|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
11054843|NCT01328782|OG002|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
11054844|NCT01328782|EG000|Reported Event|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
11054845|NCT01328782|EG001|Reported Event|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
11054846|NCT01328782|EG002|Reported Event|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
11054847|NCT01328873|BG000|Baseline|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
11054848|NCT01328873|FG000|Participant Flow|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
11054849|NCT01328873|OG000|Outcome|All Patients Will Receive Lab Testing on Bronchoscopy Specimen|
11054850|NCT01328873|OG000|Outcome|Laboratory Testing|"Patients were evaluated by changes on the CT and categorized as follows:~Air space~ground glass/reticular nodular~nodular/cavitary~single patchy infiltrate~These were evaluated on CT scans and all units of measure are the same."
11054851|NCT01328873|OG000|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
11054852|NCT01328873|EG000|Reported Event|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
11054853|NCT01328951|BG000|Baseline|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
11054854|NCT01328951|BG001|Baseline|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
11054855|NCT01328951|BG002|Baseline|Total|Total of all reporting groups
11054856|NCT01328951|FG000|Participant Flow|Late Erlotinib|Participants received blinded placebo tablets orally (PO) once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
11054857|NCT01328951|FG001|Participant Flow|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not epidermal growth factor receptor [EGFR] targeted therapies) or best supportive care (BSC) as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
11054858|NCT01328951|OG000|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
11054859|NCT01328951|OG001|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
11054860|NCT01328951|OG000|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
11054861|NCT01328951|OG001|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
11054862|NCT01328951|EG000|Reported Event|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
11054863|NCT01328951|EG001|Reported Event|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
11054864|NCT01328951|EG002|Reported Event|Second-Line Erlotinib (Late Erlotinib)|Participants who received blinded placebo and who demonstrated disease progression were unblinded and could receive second-line erlotinib as 150-mg tablets PO once daily, provided by the Sponsor. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
11054865|NCT01328951|EG003|Reported Event|Second-Line Chemotherapy (Early Erlotinib)|Participants who received blinded erlotinib and who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
11054866|NCT01328964|BG000|Baseline|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
11054867|NCT01328964|BG001|Baseline|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
11054868|NCT01328964|BG002|Baseline|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
11054869|NCT01328964|BG003|Baseline|Total|Total of all reporting groups
11054870|NCT01328964|FG000|Participant Flow|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
11054871|NCT01328964|FG001|Participant Flow|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
11054872|NCT01328964|FG002|Participant Flow|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
11054873|NCT01328964|OG000|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
11054874|NCT01328964|OG001|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
11054875|NCT01328964|OG001|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
11054876|NCT01328964|EG000|Reported Event|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
11054877|NCT01328964|EG001|Reported Event|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
11054878|NCT01328964|EG002|Reported Event|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
11054879|NCT01329029|BG000|Baseline|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
11054880|NCT01329029|BG001|Baseline|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
11349035|NCT04128293|BG001|Baseline|Sequence 2 - Treatment BADC|Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
11054881|NCT01329029|BG002|Baseline|Total|Total of all reporting groups
11054882|NCT01329029|FG000|Participant Flow|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
11054883|NCT01329029|FG001|Participant Flow|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
11054884|NCT01329029|OG000|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
11054885|NCT01329029|OG001|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
11054886|NCT01329029|EG000|Reported Event|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
11054887|NCT01329029|EG001|Reported Event|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
11054888|NCT01329185|BG000|Baseline|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
11054889|NCT01329185|BG001|Baseline|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
11054890|NCT01329185|BG002|Baseline|Total|Total of all reporting groups
11054891|NCT01329185|FG000|Participant Flow|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
11054892|NCT01329185|FG001|Participant Flow|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
11054893|NCT01329185|OG000|Outcome|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
11054894|NCT01329185|OG001|Outcome|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
11054895|NCT01329185|EG000|Reported Event|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
11054896|NCT01329185|EG001|Reported Event|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
11054897|NCT01329198|BG000|Baseline|Delayed Activation DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system. By Day 60, all subjects will be programmed to receive active stimulation.~There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
11054898|NCT01329198|BG001|Baseline|Immediate Activation DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
11054899|NCT01329198|BG002|Baseline|Total|Total of all reporting groups
11054900|NCT01329198|FG000|Participant Flow|Delayed Activation DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system. By Day 60, all subjects will be programmed to receive active stimulation.~There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (will undergo identical programming procedures at 30 and 60 days."
11054901|NCT01329198|FG001|Participant Flow|Immediate Activation DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
11054902|NCT01329198|OG000|Outcome|Delayed Activation DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system. By Day 60, all subjects will be programmed to receive active stimulation.~There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
11054903|NCT01329198|OG001|Outcome|Immediate Activation DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
11054904|NCT01329198|OG000|Outcome|Subject 1|
11054905|NCT01329198|OG001|Outcome|Subject 2|
11054906|NCT01329198|OG002|Outcome|Subject 3|
11054907|NCT01329198|OG003|Outcome|Subject 4|
11054908|NCT01329198|OG004|Outcome|Subject 5|
11054909|NCT01329198|EG000|Reported Event|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
11054910|NCT01329198|EG001|Reported Event|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
11054911|NCT01329263|BG000|Baseline|Experimental|Group switched from menthol cigarette to non-menthol cigarette
11054912|NCT01329263|BG001|Baseline|Control|Participants smoked their own menthol brand cigarette throughout the study.
11054913|NCT01329263|BG002|Baseline|Total|Total of all reporting groups
11054914|NCT01329263|FG000|Participant Flow|Control|Control group: continued to smoke same, own brand cigarette.
11054915|NCT01329263|FG001|Participant Flow|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
11054916|NCT01329263|OG000|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
11054917|NCT01329263|OG001|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
11054918|NCT01329263|OG000|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
11054919|NCT01329263|OG001|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
11054920|NCT01329263|EG000|Reported Event|Control|Control group: continued to smoke same, own brand cigarette.
11054921|NCT01329263|EG001|Reported Event|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
11054922|NCT01329328|BG000|Baseline|CONTROL|NO VIBRATION EXERCISE
11054923|NCT01329328|BG001|Baseline|VIBRATION EXERCISE|"WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY~vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, without localized delivery of heating radiofrequency"
11054924|NCT01329328|BG002|Baseline|VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION|"WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIO, MILAN, ITALY PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY~vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, with localized delivery of heating radiofrequency"
11054925|NCT01329328|BG003|Baseline|Total|Total of all reporting groups
11054926|NCT01329328|FG000|Participant Flow|CONTROL|CONTROL GROUP NO INTERVENTION
11054927|NCT01329328|FG001|Participant Flow|WHOLE-BODY VIBRATION|EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY
11054928|NCT01329328|FG002|Participant Flow|WHOLE-BODY VIBRATION PLUS RADIOFREQUENCY|EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF,BIOS, MILAN, ITALY) PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY
11054929|NCT01329328|OG000|Outcome|CONTROL|NO VIBRATION EXERCISE
11054930|NCT01329328|OG001|Outcome|VIBRATION EXERCISE|"WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY~vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency"
11054931|NCT01329328|OG002|Outcome|VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION|"WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIO, MILAN, ITALY PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY~vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency"
11054932|NCT01329328|EG000|Reported Event|CONTROL|NO VIBRATION EXERCISE
11054933|NCT01329328|EG001|Reported Event|VIBRATION EXERCISE|"WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY~vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency"
11054934|NCT01329328|EG002|Reported Event|VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION|"WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIO, MILAN, ITALY PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY~vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency"
11054935|NCT01329380|BG000|Baseline|Adalimumab|Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
11054936|NCT01329380|FG000|Participant Flow|Adalimumab|Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
11054937|NCT01329380|OG000|Outcome|Adalimumab|Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
11054938|NCT01329380|EG000|Reported Event|Adalimumab|Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
11054939|NCT01329419|BG000|Baseline|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
11054940|NCT01329419|FG000|Participant Flow|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
11054941|NCT01329419|OG000|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
11054942|NCT01329419|OG000|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
11054943|NCT01329419|EG000|Reported Event|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
11054944|NCT01329562|BG000|Baseline|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
11054945|NCT01329562|BG001|Baseline|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
11054946|NCT01329562|BG002|Baseline|Total|Total of all reporting groups
11054947|NCT01329562|FG000|Participant Flow|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
11054948|NCT01329562|FG001|Participant Flow|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
11054949|NCT01329562|OG000|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
11054950|NCT01329562|OG001|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
11054951|NCT01329562|OG001|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
11149343|NCT01870583|BG000|Baseline|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.~Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
11054952|NCT01329562|OG002|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
11054953|NCT01329562|EG000|Reported Event|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
11054954|NCT01329562|EG001|Reported Event|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
11054955|NCT01329679|BG000|Baseline|All Study Participants|Energy drink: Energy drink, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring
11054956|NCT01329679|FG000|Participant Flow|Energy Drink, Then Placebo|Energy drink, 2 oz twice daily for 7 days, washout period, then Placebo: Water, lime juice and cherry flavoring
11054957|NCT01329679|FG001|Participant Flow|Placebo, Then Energy Drink|Placebo: Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days, washout period, then energy drink, 2 oz twice daily for 7 days
11054958|NCT01329679|OG000|Outcome|Energy Drink|Energy drink: Energy drink, 2oz twice daily for 7 days
11054959|NCT01329679|OG001|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
11054960|NCT01329679|OG000|Outcome|Energy Drink|Energy drink: Energy drink, 2 oz twice daily for 7 days
11054961|NCT01329679|OG000|Outcome|Energy Drink|Energy drink, 2oz twice daily for 7 days
11054962|NCT01329679|EG000|Reported Event|Energy Drink|Energy drink: Energy drink, 2oz twice daily for 7 days
11054963|NCT01329679|EG001|Reported Event|Placebo|Placebo: Water, lime juice and cherry flavoring
11054964|NCT01329848|BG000|Baseline|Discomfort Symptoms|level of discomfort symptoms while performing near work
11054965|NCT01329848|FG000|Participant Flow|Discomfort Symptoms|levels of discomfort while performing near work
11054966|NCT01329848|OG000|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
11054967|NCT01329848|EG000|Reported Event|Changes in Visual Discomfort From Baseline|Visual discomfort while making auto-refraction recordings.
11054968|NCT01329900|BG000|Baseline|Ofatumumab + Stem Cell Collection|Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide). After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose. G-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.
11054969|NCT01329900|FG000|Participant Flow|Ofatumumab + Stem Cell Collection|Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide). After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose. G-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.
11054970|NCT01329900|OG000|Outcome|Ofatumumab + Stem Cell Collection|Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide). After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose. G-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.
11149344|NCT01870583|BG001|Baseline|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery~Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
11149345|NCT01870583|BG002|Baseline|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery~Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
11149346|NCT01870583|BG003|Baseline|Total|Total of all reporting groups
11054971|NCT01329900|EG000|Reported Event|Ofatumumab + Stem Cell Collection|Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide). After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose. G-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.
11054972|NCT01329939|BG000|Baseline|Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
11054973|NCT01329939|BG001|Baseline|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
11054974|NCT01329939|BG002|Baseline|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
11054975|NCT01329939|BG003|Baseline|Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
11054976|NCT01329939|BG004|Baseline|Total|Total of all reporting groups
11054977|NCT01329939|FG000|Participant Flow|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
11054978|NCT01329939|FG001|Participant Flow|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
11054979|NCT01329939|FG002|Participant Flow|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
11054980|NCT01329939|FG003|Participant Flow|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
11054981|NCT01329939|OG000|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
11054982|NCT01329939|OG001|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
11054983|NCT01329939|OG002|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
11054984|NCT01329939|OG003|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
11054985|NCT01329939|EG000|Reported Event|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
10847095|NCT00281671|OG001|Outcome|Nesiritide|"In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.~For this arm, the data reflect the urine output during the last 5 hours of the nesiritide 0.015 mcg/kg/hour infusion for all 9 patients."
11054986|NCT01329939|EG001|Reported Event|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
11054987|NCT01329939|EG002|Reported Event|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
11054988|NCT01329939|EG003|Reported Event|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
11054989|NCT01329978|BG000|Baseline|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
11054990|NCT01329978|BG001|Baseline|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
11054991|NCT01329978|BG002|Baseline|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
11054992|NCT01329978|BG003|Baseline|Total|Total of all reporting groups
11054993|NCT01329978|FG000|Participant Flow|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive sofosbuvir (SOF) 400 mg+pegylated interferon alfa-2a (PEG) 180 µg+ribavirin (RBV) 1000-1200 mg for 12 weeks.
11054994|NCT01329978|FG001|Participant Flow|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
11054995|NCT01329978|FG002|Participant Flow|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
11054996|NCT01329978|FG003|Participant Flow|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
11054997|NCT01329978|FG004|Participant Flow|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
11054998|NCT01329978|OG000|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
11054999|NCT01329978|OG001|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
11055000|NCT01329978|OG002|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
11055001|NCT01329978|OG003|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
11055002|NCT01329978|OG004|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
11055003|NCT01329978|OG002|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
11055004|NCT01329978|OG003|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
11055005|NCT01329978|EG000|Reported Event|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
11055006|NCT01329978|EG001|Reported Event|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
11055007|NCT01329978|EG002|Reported Event|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
11055008|NCT01330017|BG000|Baseline|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055009|NCT01330017|BG001|Baseline|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055010|NCT01330017|BG002|Baseline|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055011|NCT01330017|BG003|Baseline|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055012|NCT01330017|BG004|Baseline|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
11055013|NCT01330017|BG005|Baseline|Total|Total of all reporting groups
11055014|NCT01330017|FG000|Participant Flow|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055015|NCT01330017|FG001|Participant Flow|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055016|NCT01330017|FG002|Participant Flow|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055017|NCT01330017|FG003|Participant Flow|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055018|NCT01330017|FG004|Participant Flow|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
11055019|NCT01330017|OG000|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055020|NCT01330017|OG001|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055021|NCT01330017|OG002|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055022|NCT01330017|OG003|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055023|NCT01330017|OG004|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
11055024|NCT01330017|EG000|Reported Event|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055025|NCT01330017|EG001|Reported Event|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055026|NCT01330017|EG002|Reported Event|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055027|NCT01330017|EG003|Reported Event|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
11055028|NCT01330017|EG004|Reported Event|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
11055029|NCT01330030|BG000|Baseline|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
11055030|NCT01330030|BG001|Baseline|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
11055031|NCT01330030|BG002|Baseline|Total|Total of all reporting groups
11055032|NCT01330030|FG000|Participant Flow|Drug Selegiline|6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
11055033|NCT01330030|FG001|Participant Flow|Matching Placebo|matching placebo worn 24 hours for 8 weeks
11055034|NCT01330030|OG000|Outcome|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
11055035|NCT01330030|OG001|Outcome|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
11055036|NCT01330030|EG000|Reported Event|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
11055037|NCT01330030|EG001|Reported Event|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
11055038|NCT01330043|BG000|Baseline|Maintenance Treatment|Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 26.
11055039|NCT01330043|BG001|Baseline|Extended Treatment|Participants receive 52 weeks of cognitive behavioral therapy (maintenance plus extended treatment). Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
11055040|NCT01330043|BG002|Baseline|Total|Total of all reporting groups
11055041|NCT01330043|FG000|Participant Flow|Maintenance Therapy|Participants will receive six months (26 weeks) of cognitive behavioral therapy (maintenance treatment) and a monthly phone call after 26 weeks asking about their smoking status and will not receive any treatment.
11349036|NCT04128293|BG002|Baseline|Sequence 3 - Treatment CDAB|Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
11055042|NCT01330043|FG001|Participant Flow|Extended Treatment|Participants will receive twelve months (52 weeks) of cognitive behavioral therapy.
11055043|NCT01330043|OG000|Outcome|Maintenance Treatment|Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
11055044|NCT01330043|OG001|Outcome|Extended Treatment|Participants receive 52 weeks of cognitive behavioral therapy (extended treatment). During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
11055045|NCT01330043|EG000|Reported Event|Maintenance Treatment|"Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26.~Maintenance treatment (cognitive behavioral therapy)(CBT): During open label treatment, all receive CBT and bupropion and NRT patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 1"
11055046|NCT01330043|EG001|Reported Event|Extended Treatment|"Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by another 26 weeks of cognitive behavioral therapy (extended treatment). Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26.~Maintenance treatment (cognitive behavioral therapy)(CBT): During open label treatment, all receive CBT and bupropion and NRT patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of cravin"
11055047|NCT01330108|BG000|Baseline|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
11055048|NCT01330108|FG000|Participant Flow|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
11055049|NCT01330108|OG000|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
11055050|NCT01330108|EG000|Reported Event|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
11055051|NCT01330134|BG000|Baseline|Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection|lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.
11055052|NCT01330134|BG001|Baseline|Lidocaine Subcutaneous Injection Alone|lidocaine: 1% lidocaine subcutaneous injection alone.
11055053|NCT01330134|BG002|Baseline|Total|Total of all reporting groups
11055054|NCT01330134|FG000|Participant Flow|Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection|lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.
11055055|NCT01330134|FG001|Participant Flow|Lidocaine Subcutaneous Injection Alone|lidocaine: 1% lidocaine subcutaneous injection alone.
11055056|NCT01330134|OG000|Outcome|Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection|lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.
11055057|NCT01330134|OG001|Outcome|Lidocaine Subcutaneous Injection Alone|lidocaine: 1% lidocaine subcutaneous injection alone.
11055058|NCT01330134|EG000|Reported Event|Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection|lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection
11055059|NCT01330134|EG001|Reported Event|Lidocaine Subcutaneous Injection Alone|lidocaine: 1% lidocaine subcutaneous injection alone
11055060|NCT01330290|BG000|Baseline|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
11055061|NCT01330290|FG000|Participant Flow|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
11055062|NCT01330290|OG000|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
11055063|NCT01330290|EG000|Reported Event|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
11055064|NCT01330303|BG000|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 or reference product in Period 1 and test product in Period 2
11055065|NCT01330303|FG000|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
11055066|NCT01330303|FG001|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
11055067|NCT01330303|OG000|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
11055068|NCT01330303|OG001|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both periods
11055069|NCT01330303|OG001|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
11055070|NCT01330303|EG000|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
11055071|NCT01330303|EG001|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
11055072|NCT01330316|BG000|Baseline|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
11055073|NCT01330316|BG001|Baseline|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
11055074|NCT01330316|BG002|Baseline|Total|Total of all reporting groups
11055075|NCT01330316|FG000|Participant Flow|Relapse|"Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients.~At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV.~ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8.~Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser."
11055076|NCT01330316|FG001|Participant Flow|Non-relapse|"Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients.~Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10 decrease in HCV RNA from baseline during the treatment period.~Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA.~Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment."
11055077|NCT01330316|OG000|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
11055078|NCT01330316|OG001|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
11055079|NCT01330316|EG000|Reported Event|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
11055080|NCT01330316|EG001|Reported Event|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
11055081|NCT01330355|BG000|Baseline|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
11055082|NCT01330355|BG001|Baseline|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
11055083|NCT01330355|BG002|Baseline|Total|Total of all reporting groups
11055084|NCT01330355|FG000|Participant Flow|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
11055085|NCT01330355|FG001|Participant Flow|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
11055086|NCT01330355|OG000|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
11055087|NCT01330355|OG001|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
11055088|NCT01330355|EG000|Reported Event|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
11055089|NCT01330355|EG001|Reported Event|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
11055090|NCT01330381|BG000|Baseline|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
11055091|NCT01330381|BG001|Baseline|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
11055092|NCT01330381|BG002|Baseline|Total|Total of all reporting groups
11055093|NCT01330381|FG000|Participant Flow|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
11055094|NCT01330381|FG001|Participant Flow|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching prucalopride oral tablet.
11055095|NCT01330381|FG002|Participant Flow|PEG 4000 (Polyethylene Glycol)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
11055096|NCT01330381|OG000|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
11055097|NCT01330381|OG001|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
11055098|NCT01330381|OG001|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
11055099|NCT01330381|EG000|Reported Event|Prucalopride (Double-blind Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
11055100|NCT01330381|EG001|Reported Event|Placebo (Double-blind Period)|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
11055101|NCT01330381|EG002|Reported Event|Prucalopride (Open-label Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
11055102|NCT01330381|EG003|Reported Event|PEG 4000 (Open-label Period)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
11055103|NCT01330394|BG000|Baseline|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
11055104|NCT01330394|BG001|Baseline|Active tDCS|active transcranial Direct Current Stimulation
11055105|NCT01330394|BG002|Baseline|Total|Total of all reporting groups
11055106|NCT01330394|FG000|Participant Flow|Sham-tDCS Control|simulate control for bilateral transcranial Direct Current Stimulation on the left and right dorsolateral prefrontal cortex
11055107|NCT01330394|FG001|Participant Flow|Active tDCS|active transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 2 mA, double 13 min stimulation with 20 min interval between them) was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex once a day for 5 consecutive days
11055108|NCT01330394|OG000|Outcome|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
11055109|NCT01330394|OG001|Outcome|Active tDCS|active transcranial Direct Current Stimulation
11055110|NCT01330394|EG000|Reported Event|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
11055111|NCT01330394|EG001|Reported Event|Active tDCS|active transcranial Direct Current Stimulation
11055112|NCT01330420|BG000|Baseline|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.~The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
11341940|NCT03693742|OG000|Outcome|MSG Intervention|After a fasting period of 4 hours, participants first received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
11341941|NCT03693742|OG001|Outcome|Placebo Intervention|After a fasting period of 4 hours, participants first received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
11149347|NCT01870583|FG000|Participant Flow|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.~Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
11149348|NCT01870583|FG001|Participant Flow|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery~Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
11149349|NCT01870583|FG002|Participant Flow|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery~Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
11149350|NCT01870583|OG000|Outcome|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.~Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
11149351|NCT01870583|OG001|Outcome|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery~Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
11149352|NCT01870583|OG002|Outcome|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery~Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
11149353|NCT01870583|EG000|Reported Event|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.~Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
11149354|NCT01870583|EG001|Reported Event|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery~Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
11149355|NCT01870583|EG002|Reported Event|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery~Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
11149356|NCT01870596|BG000|Baseline|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11149357|NCT01870596|BG001|Baseline|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11149358|NCT01870596|BG002|Baseline|Total|Total of all reporting groups
11149359|NCT01870596|FG000|Participant Flow|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11149360|NCT01870596|FG001|Participant Flow|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11149361|NCT01870596|OG000|Outcome|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11149362|NCT01870596|OG001|Outcome|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11149363|NCT01870596|EG000|Reported Event|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11149364|NCT01870596|EG001|Reported Event|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11149365|NCT01870726|BG000|Baseline|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
11149366|NCT01870726|BG001|Baseline|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
11149367|NCT01870726|BG002|Baseline|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
11149368|NCT01870726|BG003|Baseline|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
11149369|NCT01870726|BG004|Baseline|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
11149370|NCT01870726|BG005|Baseline|400 mg BID Tab +80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
11149371|NCT01870726|BG006|Baseline|400 mg BID Tab|Phase II: 400 mg INC280 (BID) tablet
11149372|NCT01870726|BG007|Baseline|Total|Total of all reporting groups
11149373|NCT01870726|FG000|Participant Flow|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
11149374|NCT01870726|FG001|Participant Flow|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
11149375|NCT01870726|FG002|Participant Flow|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
11149376|NCT01870726|FG003|Participant Flow|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
11149377|NCT01870726|FG004|Participant Flow|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
11149378|NCT01870726|FG005|Participant Flow|400 mg BID Tab +80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
11149379|NCT01870726|FG006|Participant Flow|400 mg BID Tab|Phase II: 400 mg INC280 (BID) tablet
11055113|NCT01330420|FG000|Participant Flow|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
11055114|NCT01330420|OG000|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
11055115|NCT01330420|EG000|Reported Event|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.~The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
11055116|NCT01330433|BG000|Baseline|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
11055117|NCT01330433|BG001|Baseline|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
11055118|NCT01330433|BG002|Baseline|Total|Total of all reporting groups
11055119|NCT01330433|FG000|Participant Flow|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
11055120|NCT01330433|FG001|Participant Flow|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
11055121|NCT01330433|OG000|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
11055122|NCT01330433|OG001|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
11055123|NCT01330433|EG000|Reported Event|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
11055124|NCT01330433|EG001|Reported Event|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
11055125|NCT01330459|BG000|Baseline|Hydrocodone/Acetaminophen|Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.
11055126|NCT01330459|BG001|Baseline|Placebo|Subject will receive placebo 45-90 minutes prior to abortion procedure.
11055127|NCT01330459|BG002|Baseline|Total|Total of all reporting groups
11055128|NCT01330459|FG000|Participant Flow|Hydrocodone/Acetaminophen|Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.
11055129|NCT01330459|FG001|Participant Flow|Placebo|Subject will receive placebo 45-90 minutes prior to abortion procedure.
11055130|NCT01330459|OG000|Outcome|Hydrocodone/Acetaminophen|Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.
11055131|NCT01330459|OG001|Outcome|Placebo|Subject will receive placebo 45-90 minutes prior to abortion procedure.
11055132|NCT01330459|OG000|Outcome|Hydrocodone/Acetaminophen|"Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.~Subject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.~Hydrocodone/acetaminophen: Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.~Ibuprofen: 800 mg oral ibuprofen~Lorazepam: 2 mg oral lorazepam~Lidocaine: 20 ml 1% buffered lidocaine, injected"
11055133|NCT01330459|OG001|Outcome|Placebo|"Subject will receive placebo 45-90 minutes prior to abortion procedure.~Subject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.~Placebo: Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.~Ibuprofen: 800 mg oral ibuprofen~Lorazepam: 2 mg oral lorazepam~Lidocaine: 20 ml 1% buffered lidocaine, injected"
11055134|NCT01330459|EG000|Reported Event|Hydrocodone/Acetaminophen|Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.
11055135|NCT01330459|EG001|Reported Event|Placebo|Subject will receive placebo 45-90 minutes prior to abortion procedure.
11055136|NCT01330628|BG000|Baseline|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
11055137|NCT01330628|BG001|Baseline|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
11055138|NCT01330628|BG002|Baseline|Total|Total of all reporting groups
11055139|NCT01330628|FG000|Participant Flow|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
11055140|NCT01330628|FG001|Participant Flow|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
11055141|NCT01330628|OG000|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
11055142|NCT01330628|OG001|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
11055143|NCT01330628|EG000|Reported Event|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
11055144|NCT01330628|EG001|Reported Event|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
11055145|NCT01330914|BG000|Baseline|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
11055146|NCT01330914|FG000|Participant Flow|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
11055147|NCT01330914|OG000|Outcome|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
11055148|NCT01330914|EG000|Reported Event|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
11055149|NCT01330953|BG000|Baseline|Placebo|Single intravenous placebo dose.
11055150|NCT01330953|BG001|Baseline|30 mg LY2928057|Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
11055151|NCT01330953|BG002|Baseline|100 mg LY2928057|Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
11055152|NCT01330953|BG003|Baseline|300 mg LY2928057|Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
11055153|NCT01330953|BG004|Baseline|1000 mg LY2928057|Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
11055154|NCT01330953|BG005|Baseline|Total|Total of all reporting groups
11055155|NCT01330953|FG000|Participant Flow|Placebo|Single intravenous placebo dose.
11055156|NCT01330953|FG001|Participant Flow|30 mg LY2928057|Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
11055157|NCT01330953|FG002|Participant Flow|100 mg LY2928057|Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
11055158|NCT01330953|FG003|Participant Flow|300 mg LY2928057|Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
11055159|NCT01330953|FG004|Participant Flow|1000 mg LY2928057|Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
11055160|NCT01330953|OG000|Outcome|Placebo|Single intravenous placebo dose.
11055161|NCT01330953|OG001|Outcome|30 mg LY2928057|Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
11055162|NCT01330953|OG002|Outcome|100 mg LY2928057|Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
11055163|NCT01330953|OG003|Outcome|300 mg LY2928057|Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
11055164|NCT01330953|OG004|Outcome|1000 mg LY2928057|Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
11055165|NCT01330953|OG000|Outcome|30 mg LY2928057|Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
11055166|NCT01330953|OG001|Outcome|100 mg LY2928057|Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
11055167|NCT01330953|OG002|Outcome|300 mg LY2928057|Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
11055168|NCT01330953|OG003|Outcome|1000 mg LY2928057|Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
11055169|NCT01330953|OG000|Outcome|30 mg LY2928057|Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and Day 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
11055170|NCT01330953|EG000|Reported Event|Placebo|Single intravenous placebo dose.
11055171|NCT01330953|EG001|Reported Event|30 mg LY2928057|Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
11055172|NCT01330953|EG002|Reported Event|100 mg LY2928057|Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
11055173|NCT01330953|EG003|Reported Event|300 mg LY2928057|Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
11055174|NCT01330953|EG004|Reported Event|1000 mg LY2928057|Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
11055175|NCT01330966|BG000|Baseline|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle."
11055176|NCT01330966|FG000|Participant Flow|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle."
11055177|NCT01330966|OG000|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle."
11055178|NCT01330966|EG000|Reported Event|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle."
11055179|NCT01331005|BG000|Baseline|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
11055180|NCT01331005|BG001|Baseline|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
11055181|NCT01331005|BG002|Baseline|Total|Total of all reporting groups
11055182|NCT01331005|FG000|Participant Flow|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
11055183|NCT01331005|FG001|Participant Flow|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
11055184|NCT01331005|OG000|Outcome|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
11055185|NCT01331005|OG001|Outcome|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
11055186|NCT01331005|EG000|Reported Event|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
11055187|NCT01331005|EG001|Reported Event|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
11055188|NCT01331083|BG000|Baseline|Group A|Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
11055189|NCT01331083|BG001|Baseline|Group B|Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
11055190|NCT01331083|BG002|Baseline|Total|Total of all reporting groups
11055191|NCT01331083|FG000|Participant Flow|Group A|Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
11055192|NCT01331083|FG001|Participant Flow|Group B|Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
11055193|NCT01331083|OG000|Outcome|Group A|Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
11055194|NCT01331083|OG001|Outcome|Group B|Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
11055195|NCT01331083|EG000|Reported Event|Group A|Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
11055196|NCT01331083|EG001|Reported Event|Group B|Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
11055197|NCT01331109|BG000|Baseline|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
11055198|NCT01331109|FG000|Participant Flow|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
11055199|NCT01331109|OG000|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
11055200|NCT01331109|EG000|Reported Event|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
11055201|NCT01331161|BG000|Baseline|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
11055202|NCT01331161|BG001|Baseline|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
11055203|NCT01331161|BG002|Baseline|Total|Total of all reporting groups
11055204|NCT01331161|FG000|Participant Flow|Older Group|"Participants between the ages of 60-79~ZOSTAVAX: shingles vaccine, one dose"
11055205|NCT01331161|FG001|Participant Flow|Younger Group|"Participants between the ages of 25-40~ZOSTAVAX: shingles vaccine, one dose"
11055206|NCT01331161|OG000|Outcome|Participants 60-79 Years|participants who received one dose of vaccine
11055207|NCT01331161|OG001|Outcome|Participants 25-40 Years of Age|participants with one dose of vaccine
11055208|NCT01331161|OG000|Outcome|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
11055209|NCT01331161|OG001|Outcome|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
11055210|NCT01331161|EG000|Reported Event|Older Group|"Participants between the ages of 60-79~ZOSTAVAX: shingles vaccine, one dose"
11055211|NCT01331161|EG001|Reported Event|Younger Group|"Participants between the ages of 25-40~ZOSTAVAX: shingles vaccine, one dose"
11055212|NCT01331213|BG000|Baseline|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
11055213|NCT01331213|BG001|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
11055214|NCT01331213|BG002|Baseline|Total|Total of all reporting groups
11055215|NCT01331213|FG000|Participant Flow|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
11055216|NCT01331213|FG001|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
11055217|NCT01331213|OG000|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
11055218|NCT01331213|OG001|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
11055219|NCT01331213|EG000|Reported Event|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
11055220|NCT01331213|EG001|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
11055221|NCT01331239|BG000|Baseline|Part l: Core Cohort|Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
11055222|NCT01331239|BG001|Baseline|Part II Core: Expansion Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study.
11055223|NCT01331239|BG002|Baseline|Total|Total of all reporting groups
11055224|NCT01331239|FG000|Participant Flow|Part l: Core Cohort|Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
11055225|NCT01331239|FG001|Participant Flow|Part II Core: Expansion Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study.
11055226|NCT01331239|FG002|Participant Flow|Part ll Core: Follow-up Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
11055227|NCT01331239|OG000|Outcome|Part l: Core Cohort|Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
11055228|NCT01331239|OG000|Outcome|Part II Core: Expansion Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study.
11055229|NCT01331239|OG001|Outcome|Part ll Core: Follow-up Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
11055230|NCT01331239|OG001|Outcome|Part II Core: Follow-up Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
11055231|NCT01331239|OG000|Outcome|Part ll Core: Expansion Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study.
11055232|NCT01331239|OG000|Outcome|2mg Bid|Participants in the Expansion cohort who took 2mg of osilodrostat
11055233|NCT01331239|OG001|Outcome|5mg Bid|Participants in the Expansion cohort who took 5mg of osilodrostat
11055234|NCT01331239|OG002|Outcome|10mg Bid|Participants in the Expansion cohort who took 10mg of osilodrostat
11055235|NCT01331239|OG003|Outcome|20mg Bid|Participants in the Expansion cohort who took 20mg of osilodrostat
11055236|NCT01331239|OG004|Outcome|30mg Bid|Participants in the Expansion cohort who took 30mg of osilodrostat
11055237|NCT01331239|OG001|Outcome|Part II Core: Expansion Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study.
11055238|NCT01331239|EG000|Reported Event|Part l: Core Cohort|Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
11055239|NCT01331239|EG001|Reported Event|Part ll Core: Expansion Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study
11055240|NCT01331239|EG002|Reported Event|Part ll Core: Follow-up Cohort|Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study
11055241|NCT01331291|BG000|Baseline|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
11055242|NCT01331291|BG001|Baseline|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
11055243|NCT01331291|BG002|Baseline|Total|Total of all reporting groups
11055244|NCT01331291|FG000|Participant Flow|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
11055245|NCT01331291|FG001|Participant Flow|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
11055246|NCT01331291|OG000|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
11055247|NCT01331291|OG001|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
11055248|NCT01331291|EG000|Reported Event|Combined Arms|Adverse Events were measured across all participants, regardless of arm.
11055249|NCT01331304|BG000|Baseline|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
11055250|NCT01331304|BG001|Baseline|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
11055251|NCT01331304|BG002|Baseline|Total|Total of all reporting groups
11055252|NCT01331304|FG000|Participant Flow|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
11055253|NCT01331304|FG001|Participant Flow|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
11055254|NCT01331304|OG000|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
11055255|NCT01331304|OG001|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
11055256|NCT01331304|OG000|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-900mg per day over 6 months"
11055257|NCT01331304|EG000|Reported Event|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
11055258|NCT01331304|EG001|Reported Event|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
11055259|NCT01331408|BG000|Baseline|Macrolane VRF30|"Injection of Macrolane VRF30 in buttocks~Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject"
11055260|NCT01331408|FG000|Participant Flow|Macrolane VRF30|"Injection of Macrolane VRF30 in buttocks~Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject"
11055261|NCT01331408|OG000|Outcome|Macrolane VRF30|"Injection of Macrolane VRF30 in buttocks~Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject"
11055262|NCT01331408|EG000|Reported Event|Macrolane VRF30|"Injection of Macrolane VRF30 in buttocks~Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject"
11055263|NCT01331681|BG000|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
11055264|NCT01331681|BG001|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
11055265|NCT01331681|BG002|Baseline|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
11055266|NCT01331681|BG003|Baseline|Total|Total of all reporting groups
11055267|NCT01331681|FG000|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
11055268|NCT01331681|FG001|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
11055269|NCT01331681|FG002|Participant Flow|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
11055270|NCT01331681|OG000|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
11055271|NCT01331681|OG001|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
11055272|NCT01331681|OG002|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
11055273|NCT01331681|EG000|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
11055274|NCT01331681|EG001|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
11055275|NCT01331681|EG002|Reported Event|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. During year 3 laser patients could receive IAI as needed (PRN) .
11055276|NCT01331694|BG000|Baseline|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
11055277|NCT01331694|BG001|Baseline|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
11055278|NCT01331694|BG002|Baseline|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
11055279|NCT01331694|BG003|Baseline|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
11055280|NCT01331694|BG004|Baseline|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
11055281|NCT01331694|BG005|Baseline|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
11055282|NCT01331694|BG006|Baseline|Total|Total of all reporting groups
11055283|NCT01331694|FG000|Participant Flow|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 micrograms (mcg)/50 mcg
11055284|NCT01331694|FG001|Participant Flow|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
11055285|NCT01331694|FG002|Participant Flow|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
11055286|NCT01331694|FG003|Participant Flow|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
11055287|NCT01331694|FG004|Participant Flow|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
11055288|NCT01331694|FG005|Participant Flow|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
11055289|NCT01331694|OG000|Outcome|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
11055290|NCT01331694|OG001|Outcome|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
11055291|NCT01331694|OG002|Outcome|Risk Population TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
11055292|NCT01331694|OG000|Outcome|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
11055293|NCT01331694|OG001|Outcome|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
11055294|NCT01331694|OG002|Outcome|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
11055295|NCT01331694|EG000|Reported Event|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
11055296|NCT01331694|EG001|Reported Event|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
11055297|NCT01331694|EG002|Reported Event|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
11055298|NCT01331694|EG003|Reported Event|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
11055299|NCT01331694|EG004|Reported Event|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
11055300|NCT01331694|EG005|Reported Event|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
11055301|NCT01331824|BG000|Baseline|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
11055302|NCT01331824|FG000|Participant Flow|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
11055303|NCT01331824|OG000|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
11055304|NCT01331824|EG000|Reported Event|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
11055305|NCT01331837|BG000|Baseline|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
11055306|NCT01331837|BG001|Baseline|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
11055307|NCT01331837|BG002|Baseline|Total|Total of all reporting groups
11055308|NCT01331837|FG000|Participant Flow|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
11055309|NCT01331837|FG001|Participant Flow|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
11055310|NCT01331837|OG000|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
11055311|NCT01331837|OG001|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
11055312|NCT01331837|EG000|Reported Event|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
11055313|NCT01331837|EG001|Reported Event|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
11055314|NCT01332019|BG000|Baseline|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
11055315|NCT01332019|BG001|Baseline|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
11055316|NCT01332019|BG002|Baseline|Total|Total of all reporting groups
11055317|NCT01332019|FG000|Participant Flow|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
11055318|NCT01332019|FG001|Participant Flow|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
11055319|NCT01332019|OG000|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
11055320|NCT01332019|OG001|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
11055321|NCT01332019|EG000|Reported Event|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
11055322|NCT01332019|EG001|Reported Event|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
11066776|NCT01393964|OG001|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
11055323|NCT01332071|BG000|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Avandamet 4 mg + 1000 mg in Period 1; followed by reference product: Avandamet 2 mg + 500 mg in Period 2 or reference product in Period 1 and test product in Period 2
11055324|NCT01332071|FG000|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
11055325|NCT01332071|FG001|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
11055326|NCT01332071|OG000|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
11055327|NCT01332071|OG001|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
11055328|NCT01332071|OG000|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
11055329|NCT01332071|OG001|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
11055330|NCT01332071|EG000|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
11055331|NCT01332071|EG001|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
11055332|NCT01332123|BG000|Baseline|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
11055333|NCT01332123|FG000|Participant Flow|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
11055334|NCT01332123|OG000|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~All participants were subjected to the same 5 interventions (neutral alignment and 4 perturbations as detailed above) in sequence to allow repeated measures (within-subject) comparisons."
11055335|NCT01332123|OG000|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
11055336|NCT01332123|EG000|Reported Event|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
11055337|NCT01332149|BG000|Baseline|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
11055338|NCT01332149|BG001|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
11055339|NCT01332149|BG002|Baseline|Total|Total of all reporting groups
11055340|NCT01332149|FG000|Participant Flow|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
11055341|NCT01332149|FG001|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
11055342|NCT01332149|OG000|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
11055343|NCT01332149|OG001|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
11055344|NCT01332149|EG000|Reported Event|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
11055345|NCT01332149|EG001|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
11055346|NCT01332188|BG000|Baseline|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
11055347|NCT01332188|BG001|Baseline|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
11055348|NCT01332188|BG002|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
11055349|NCT01332188|BG003|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
11055350|NCT01332188|BG004|Baseline|Total|Total of all reporting groups
11055351|NCT01332188|FG000|Participant Flow|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
11055352|NCT01332188|FG001|Participant Flow|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
11055353|NCT01332188|FG002|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
11055354|NCT01332188|FG003|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
11055355|NCT01332188|OG000|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
11055356|NCT01332188|OG001|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
11055357|NCT01332188|OG002|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
11055358|NCT01332188|OG003|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
11055359|NCT01332188|EG000|Reported Event|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
11055360|NCT01332188|EG001|Reported Event|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
11055361|NCT01332188|EG002|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
11055362|NCT01332188|EG003|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
11055363|NCT01332227|BG000|Baseline|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
11055364|NCT01332227|BG001|Baseline|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
11055365|NCT01332227|BG002|Baseline|Total|Total of all reporting groups
11055366|NCT01332227|FG000|Participant Flow|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
11055367|NCT01332227|FG001|Participant Flow|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
11055368|NCT01332227|OG000|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
11055369|NCT01332227|OG001|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
11055370|NCT01332227|EG000|Reported Event|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
11055371|NCT01332227|EG001|Reported Event|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
11055372|NCT01332253|BG000|Baseline|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
11055373|NCT01332253|BG001|Baseline|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
11055374|NCT01332253|BG002|Baseline|Total|Total of all reporting groups
11055375|NCT01332253|FG000|Participant Flow|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
11055376|NCT01332253|FG001|Participant Flow|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
11055377|NCT01332253|OG000|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
11055378|NCT01332253|OG001|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
11055379|NCT01332253|EG000|Reported Event|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
11055380|NCT01332253|EG001|Reported Event|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
11149380|NCT01870726|OG000|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
11149381|NCT01870726|OG001|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
11055381|NCT01332292|BG000|Baseline|FF 100 µg/Placebo or Placebo/FF 100 µg|Participants received either fluticasone furoate (FF) 100 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled FF 100 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11055382|NCT01332292|FG000|Participant Flow|Sequence 1: FF 100 µg Followed by Placebo|Participants received fluticasone furoate (FF) 100 micrograms (µg) in Treatment Period 1 and matching placebo in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
11055383|NCT01332292|FG001|Participant Flow|Sequence 2: Placebo Followed by FF 100 µg|Participants received placebo in Treatment Period 1 and FF 100 µg in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
11055384|NCT01332292|OG000|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11055385|NCT01332292|OG001|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11055386|NCT01332292|OG000|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11055387|NCT01332292|OG001|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11055388|NCT01332292|EG000|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11055389|NCT01332292|EG001|Reported Event|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11055390|NCT01332305|BG000|Baseline|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055391|NCT01332305|BG001|Baseline|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055392|NCT01332305|BG002|Baseline|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055393|NCT01332305|BG003|Baseline|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
11055394|NCT01332305|BG004|Baseline|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
11055395|NCT01332305|BG005|Baseline|Total|Total of all reporting groups
11055396|NCT01332305|FG000|Participant Flow|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11226698|NCT02377427|FG000|Participant Flow|Part A: Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilograms (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
11055397|NCT01332305|FG001|Participant Flow|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055398|NCT01332305|FG002|Participant Flow|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055399|NCT01332305|FG003|Participant Flow|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
11055400|NCT01332305|FG004|Participant Flow|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
11055401|NCT01332305|OG000|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055402|NCT01332305|OG001|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055403|NCT01332305|OG002|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055404|NCT01332305|OG003|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
11055405|NCT01332305|OG004|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
11055406|NCT01332305|EG000|Reported Event|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055407|NCT01332305|EG001|Reported Event|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055408|NCT01332305|EG002|Reported Event|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
11055409|NCT01332305|EG003|Reported Event|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
11055410|NCT01332305|EG004|Reported Event|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
11055411|NCT01332318|BG000|Baseline|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055412|NCT01332318|BG001|Baseline|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
11055413|NCT01332318|BG002|Baseline|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
11055414|NCT01332318|BG003|Baseline|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055415|NCT01332318|BG004|Baseline|Total|Total of all reporting groups
11055416|NCT01332318|FG000|Participant Flow|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055417|NCT01332318|FG001|Participant Flow|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
11055418|NCT01332318|FG002|Participant Flow|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
11055419|NCT01332318|FG003|Participant Flow|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055420|NCT01332318|OG000|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055421|NCT01332318|OG001|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
11055422|NCT01332318|OG002|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
11055423|NCT01332318|OG003|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055424|NCT01332318|OG000|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055425|NCT01332318|EG000|Reported Event|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055426|NCT01332318|EG001|Reported Event|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
11055427|NCT01332318|EG002|Reported Event|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
11149382|NCT01870726|OG002|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
11149383|NCT01870726|OG003|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
11149384|NCT01870726|OG004|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
11149385|NCT01870726|OG005|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
11055428|NCT01332318|EG003|Reported Event|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
11055429|NCT01332331|BG000|Baseline|Low Dose Ambrisentan|Participants received ambrisentan low dose tablet either 2.5 mg or 5 mg orally once daily for 24 weeks.
11055430|NCT01332331|BG001|Baseline|High Dose Ambrisentan|Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
11055431|NCT01332331|BG002|Baseline|Total|Total of all reporting groups
11055432|NCT01332331|FG000|Participant Flow|Low Dose Ambrisentan|Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
11055433|NCT01332331|FG001|Participant Flow|High Dose Ambrisentan|Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
11055434|NCT01332331|OG000|Outcome|Low Dose Ambrisentan|Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
11055435|NCT01332331|OG001|Outcome|High Dose Ambrisentan|Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
11055436|NCT01332331|OG000|Outcome|Low Dose Ambrisentan|Participants received ambrisentan low dose tablet either 2.5 mg or 5 mg orally once daily for 24 weeks.
11055437|NCT01332331|EG000|Reported Event|Low Dose Ambrisentan|Participants received ambrisentan low dose tablet either 2.5 mg or 5 mg orally once daily for 24 weeks.
11055438|NCT01332331|EG001|Reported Event|High Dose Ambrisentan|Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
11055439|NCT01332357|BG000|Baseline|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
11055440|NCT01332357|FG000|Participant Flow|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
11055441|NCT01332357|OG000|Outcome|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
11055442|NCT01332357|EG000|Reported Event|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
11055443|NCT01332435|BG000|Baseline|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
11055444|NCT01332435|BG001|Baseline|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055445|NCT01332435|BG002|Baseline|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055446|NCT01332435|BG003|Baseline|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055447|NCT01332435|BG004|Baseline|Total|Total of all reporting groups
11055448|NCT01332435|FG000|Participant Flow|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
11055449|NCT01332435|FG001|Participant Flow|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055450|NCT01332435|FG002|Participant Flow|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055451|NCT01332435|FG003|Participant Flow|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055452|NCT01332435|OG000|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
11055453|NCT01332435|OG001|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055454|NCT01332435|OG002|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055455|NCT01332435|OG003|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055456|NCT01332435|OG001|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055457|NCT01332435|EG000|Reported Event|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
11055458|NCT01332435|EG001|Reported Event|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055459|NCT01332435|EG002|Reported Event|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055460|NCT01332435|EG003|Reported Event|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
11055461|NCT01332461|BG000|Baseline|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
11055462|NCT01332461|BG001|Baseline|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
11055463|NCT01332461|BG002|Baseline|Total|Total of all reporting groups
11055464|NCT01332461|FG000|Participant Flow|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
11055465|NCT01332461|FG001|Participant Flow|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
11055466|NCT01332461|OG000|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
11055467|NCT01332461|OG001|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
11055468|NCT01332461|EG000|Reported Event|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
11055469|NCT01332461|EG001|Reported Event|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
11055470|NCT01332487|BG000|Baseline|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
11055471|NCT01332487|BG001|Baseline|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
11055472|NCT01332487|BG002|Baseline|Total|Total of all reporting groups
11055473|NCT01332487|FG000|Participant Flow|Early Treatment|Participants who started 5-alpha-reductase inhibitor (5ARI) therapy within 30 days of initiating alpha-blocker (AB) treatment
11055474|NCT01332487|FG001|Participant Flow|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
11055475|NCT01332487|OG000|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
11055476|NCT01332487|OG001|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
11055477|NCT01332487|EG000|Reported Event|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
11055478|NCT01332487|EG001|Reported Event|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
11149386|NCT01870726|OG000|Outcome|BID Tab+Buparlisib|Phase II: INC280 (BID) as a single agent and in combination with buparlisib
11149387|NCT01870726|OG000|Outcome|BID + QD|The combination of INC280 (BID) and Buparlisib (QD).
11149388|NCT01870726|OG004|Outcome|300 mg BID Tab + 80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
11149389|NCT01870726|OG005|Outcome|400 mg BID Tab + 80 mg QD|Phase Ib: the combination of 400 mg INC280 (BID) tablet and 80 mg Buparlisib (QD) once daily
11055479|NCT01332500|BG000|Baseline|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055480|NCT01332500|BG001|Baseline|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.~Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
11055481|NCT01332500|BG002|Baseline|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055482|NCT01332500|BG003|Baseline|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055483|NCT01332500|BG004|Baseline|Total|Total of all reporting groups
11055484|NCT01332500|FG000|Participant Flow|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055485|NCT01332500|FG001|Participant Flow|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.
11055486|NCT01332500|FG002|Participant Flow|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055487|NCT01332500|FG003|Participant Flow|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055488|NCT01332500|OG000|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055489|NCT01332500|OG001|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11149390|NCT01870726|OG006|Outcome|400 mg BID Tab|Phase II: 400 mg INC280 (BID) tablet
11149391|NCT01870726|OG005|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
11149392|NCT01870726|OG000|Outcome|All Patients|The combination of INC280 (BID) and Buparlisib (QD).
11055490|NCT01332500|OG000|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055491|NCT01332500|OG001|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055492|NCT01332500|EG000|Reported Event|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055493|NCT01332500|EG001|Reported Event|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.~Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
11055494|NCT01332500|EG002|Reported Event|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055495|NCT01332500|EG003|Reported Event|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
11055496|NCT01332578|BG000|Baseline|All Randomized Participants|All randomized participants who received a study treatment during the cross over study.
11055497|NCT01332578|FG000|Participant Flow|Hot Drink Remedy First, Then Standard Paracetamol Tablets|Participants received one sachet of hot drink remedy containing 1000 milligram (mg) paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid in 150 milliliter (mL) of radio-labeled water (first intervention period). After a washout period of minimum two days, a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL water were administered (second intervention period).
11055498|NCT01332578|FG001|Participant Flow|Standard Paracetamol Tablets First, Then Hot Drink Remedy|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water (first intervention period). After a washout period of minimum two days, one sachet of hot drink remedy with 150 mL of radio-labeled water was administered (second intervention period).
11055499|NCT01332578|OG000|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
11055500|NCT01332578|OG001|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
11055501|NCT01332578|OG000|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
11055502|NCT01332578|EG000|Reported Event|Hot Drink Remedy|Participants then received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid, which was dissolved in 150 mL of radio-labeled water.
11055503|NCT01332578|EG001|Reported Event|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
11055504|NCT01332630|BG000|Baseline|Phase 1/2|TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent to day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
11149393|NCT01870726|EG000|Reported Event|INC280 200 mg BID Tab|Phase II: 200mg INC280 (BID) tablet in Phase II. A patient never received the intended PhII dose as planned (400 mg BID) but is resented as a separate group for safety.
10849055|NCT00293423|OG000|Outcome|Phase 1: Vaccine|Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
11055505|NCT01332630|FG000|Participant Flow|TPI 287|"TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mgby vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.~TPI 287: Starting dose Phase I: 160 mg/m2 by vein over 60 minutes on Days 1, 8, and 15 of every 28 day cycle.~Starting Dose Phase II: Maximum tolerated dose from Phase I.~Dexamethasone: 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287.~Benadryl: 12.5-25 mg intravenous (IV) push 30-60 minutes prior~Ranitidine: As H2 blocker 1mg/kg IV"
11055506|NCT01332630|OG000|Outcome|TPI 287|TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
11055507|NCT01332630|EG000|Reported Event|TPI 287|TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mgby vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
11055508|NCT01332721|BG000|Baseline|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
11055509|NCT01332721|FG000|Participant Flow|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
11055510|NCT01332721|OG000|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
11055511|NCT01332721|EG000|Reported Event|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
11055512|NCT01332851|BG000|Baseline|Promoting First Relationships (PFR)|"PFR is based on attachment theory and is strengths based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, an activity which includes videotaping or viewing and reflecting on a videotaped session, and time for joining - checking in with the parent, listening to their concerns and establishing a positive, supportive relationship. The sessions include handouts, one with the content area covered that day and one applying a topic to their relationship with their child. The provider also videotapes playtime between parent and child and alternates every other week with watching the video with the parent. When the parent and provider watch the video of the previous session, they reflect about what the needs are of both the parent and the child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent identify her own feelings and needs around parenting."
11066777|NCT01393964|OG002|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
11226699|NCT02377427|FG001|Participant Flow|Part A: Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
11055513|NCT01332851|BG001|Baseline|Resource & Referral|This condition will consist of 1) Resource and Referral Personal Assistance provided over the phone, and 2) Local Services Resource Packet. The participant in this arm of the intervention trial receive a phone call from a Resource and Referral Specialist hired by the project. The service consists of a needs assessment to identify the particular needs or concerns of the family (such as housing needs, mental health, tangible goods). If a need is identified, the Referral and Referral Specialist will provide the family with local information regarding the stated need (such as a phone number to a housing assistance program, location of local food bank). In addition, families in this condition will have the Research and Referral Specialist's phone number they can call if an additional need arises. The resource packet will include information organized by type of need or resource. These packets will be updated regularly as services change over time.
11055514|NCT01332851|BG002|Baseline|Total|Total of all reporting groups
11055515|NCT01332851|FG000|Participant Flow|Promoting First Relationships (PFR)|"PFR is a parenting intervention based on attachment theory and is strengths based. It is a 10 week intervention that is delivered in the home. Each week has a theme for discussion, an activity which includes videotaping or viewing and reflecting on a videotaped session, and time for joining - checking in with the parent, listening to their concerns and establishing a positive, supportive relationship. The sessions include handouts which focus on the content area covered that day and applying a topic to their relationship with their child. The provider also videotapes playtime between parent and child. On alternate weeks, the provider watches the video with the parent, reflecting on both the parent's and the child's needs. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent identify her own feelings and needs around parenting."
11055516|NCT01332851|FG001|Participant Flow|Resource & Referral (R&R)|This condition consists of 1) Resource and Referral personal assistance provided over the phone, and 2) Local Services Resource Packet. The participant receives a phone call from a Resource and Referral Specialist hired by the project. The service consists of a needs assessment to identify the particular needs or concerns of the family (such as housing needs, mental health, tangible goods). If a need is identified, the Referral and Referral Specialist will provide the family with local information regarding the stated need (such as a phone number to a housing assistance program, location of local food bank). The R&R provider makes two follow-up check in calls with the families. In addition, families can call the Research and Referral Specialist if additional needs arise. The resource packet includes information organized by type of need or resource. These packets are updated regularly as services change over time.
11055517|NCT01332851|OG000|Outcome|Promoting First Relationships (PFR)|"PFR is based on attachment theory and is strengths based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, an activity which includes videotaping or viewing and reflecting on a videotaped session, and time for joining - checking in with the parent, listening to their concerns and establishing a positive, supportive relationship. The sessions include handouts, one with the content area covered that day and one applying a topic to their relationship with their child. The provider also videotapes playtime between parent and child and alternates every other week with watching the video with the parent. When the parent and provider watch the video of the previous session, they reflect about what the needs are of both the parent and the child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent identify her own feelings and needs around parenting."
11055518|NCT01332851|OG001|Outcome|Resource & Referral|This condition will consist of 1) Resource and Referral Personal Assistance provided over the phone, and 2) Local Services Resource Packet. The participant in this arm of the intervention trial receive a phone call from a Resource and Referral Specialist hired by the project. The service consists of a needs assessment to identify the particular needs or concerns of the family (such as housing needs, mental health, tangible goods). If a need is identified, the Referral and Referral Specialist will provide the family with local information regarding the stated need (such as a phone number to a housing assistance program, location of local food bank). In addition, families in this condition will have the Research and Referral Specialist's phone number they can call if an additional need arises. The resource packet will include information organized by type of need or resource. These packets will be updated regularly as services change over time.
11055519|NCT01332851|OG000|Outcome|Promoting First Relationships (PFR)|Assigned to Promoting First Relationships (PFR) condition
11055520|NCT01332851|OG001|Outcome|Resource & Referral|Assigned to Resource and Referral condition
11055521|NCT01332851|OG000|Outcome|Promoting First Relationships (PFR)|"PFR is a parenting intervention based on attachment theory and is strengths based. It is a 10 week intervention that is delivered in the home. Each week has a theme for discussion, an activity which includes videotaping or viewing and reflecting on a videotaped session, and time for joining - checking in with the parent, listening to their concerns and establishing a positive, supportive relationship. The sessions include handouts which focus on the content area covered that day and applying a topic to their relationship with their child. The provider also videotapes playtime between parent and child. On alternate weeks, the provider watches the video with the parent, reflecting on both the parent's and the child's needs. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent identify her own feelings and needs around parenting."
11055522|NCT01332851|OG001|Outcome|Resource & Referral (R&R)|This condition consists of 1) Resource and Referral personal assistance provided over the phone, and 2) Local Services Resource Packet. The participant receives a phone call from a Resource and Referral Specialist hired by the project. The service consists of a needs assessment to identify the particular needs or concerns of the family (such as housing needs, mental health, tangible goods). If a need is identified, the Referral and Referral Specialist will provide the family with local information regarding the stated need (such as a phone number to a housing assistance program, location of local food bank). The R&R provider makes two follow-up check in calls with the families. In addition, families can call the Research and Referral Specialist if additional needs arise. The resource packet includes information organized by type of need or resource. These packets are updated regularly as services change over time.
11149394|NCT01870726|EG001|Reported Event|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
11055523|NCT01332851|EG000|Reported Event|Promoting First Relationships (PFR)|"PFR is a strengths-based 10 week in-home parenting intervention based on attachment theory. Each week has a theme for discussion, an activity, and time for joining - checking in with the parent, listening to their concerns and establishing a positive, supportive relationship. The sessions include handouts which focus on the content area covered that day and applying a topic to their relationship with their child. The provider also videotapes playtime between parent and child. On alternate weeks, the provider watches the video with the parent, reflecting on both the parent's and the child's needs. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent identify her own feelings and needs around parenting.~Promoting First Relationships (PFR): PFR is a parenting intervention based on attachment theory and is strengths based. It is a 10 week intervention that is delivered in the home of the family."
11055524|NCT01332851|EG001|Reported Event|Resource & Referral|"This condition consists of 1) Resource and Referral assistance provided over the phone, and 2) Local Services Resource Packet. The participant receives a phone call from a Resource and Referral Specialist to conduct a needs assessment to identify the particular needs or concerns of the family (such as housing needs, mental health, tangible goods). If a need is identified, the Referral and Referral Specialist will provide the family with local information regarding the stated need. The R&R provider makes two follow-up check in calls with the families. In addition, families can call the Research and Referral Specialist if additional needs arise. The resource packet includes information organized by type of need or resource. These packets are updated regularly as services change over time.~Resource and Referral: Needs assessment, followed with a resource packet sent by mail"
11055525|NCT01332981|BG000|Baseline|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
11055526|NCT01332981|FG000|Participant Flow|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
11055527|NCT01332981|OG000|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
11055528|NCT01332981|OG000|Outcome|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
11055529|NCT01332981|OG000|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
11055530|NCT01332981|OG001|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
11055531|NCT01332981|EG000|Reported Event|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
11055532|NCT01332994|BG000|Baseline|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
11055533|NCT01332994|FG000|Participant Flow|Tocilizumab (TCZ)/TCZ or TCZ/Rituximab (RTX)|All participants were assigned to receive TCZ 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using Disease Activity Score Based on 28-Joint Count (DAS28) to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of less than (<) 2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score greater than (>) 1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score less than or equal to (≤) 1.2 or a score >3.2, received RTX 1000 milligrams (mg) via IV infusion at Weeks 16 and 18.
11055534|NCT01332994|OG000|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
11149395|NCT01870726|EG002|Reported Event|400 mg BID Cap + 50 mg QD|Phase Ib: The combination of 400mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
11149396|NCT01870726|EG003|Reported Event|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
11055535|NCT01332994|EG000|Reported Event|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
11055536|NCT01333033|BG000|Baseline|Arm I (FOLFOX Regimen)|"Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by >= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.~Oxaliplatin: Given IV Leucovorin Calcium: Given IV Fluorouracil: Given IV Carboplatin: Given IV Paclitaxel: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan Radiation Therapy: Undergo RT"
11055537|NCT01333033|BG001|Baseline|Arm II (Carboplatin + Paclitaxel + Radiation)|"Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases >= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT~Carboplatin: Given IV Paclitaxel: Given IV Radiation Therapy: Undergo RT"
11055538|NCT01333033|BG002|Baseline|Total|Total of all reporting groups
11055539|NCT01333033|FG000|Participant Flow|FOLFOX Responder|Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by >= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks.
11055540|NCT01333033|FG001|Participant Flow|FOLFOX Non-Responder|Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.n Emission Tomography: Undergo PET/CT scan
11055541|NCT01333033|FG002|Participant Flow|CP Responder|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases >= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
11055542|NCT01333033|FG003|Participant Flow|CP Non-Responder|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT
11055543|NCT01333033|FG004|Participant Flow|CP No Cross-over|Carboplatin/ Paclitaxel days 1,8,22,29
11055544|NCT01333033|FG005|Participant Flow|FOLFOX6 No Cross-over|modified FOLFOX6 days 1,15, 29
11055545|NCT01333033|OG000|Outcome|FOLFOX Non-Responder|"Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by >= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.> >>>~>~>>> Oxaliplatin: Given IV>~>>>~>~>>> Leucovorin Calcium: Given IV>~>>>~>~>>> Fluorouracil: Given IV>~>>>~>~>>> Carboplatin: Given IV>~>>>~>~>>> Paclitaxel: Given IV>~>>>~>~>>> Positron Emission Tomography: Undergo PET/CT scan>~>>>~>~>>> Computed Tomography: Undergo PET/CT scan>~>>>~>~>>> Radiation Therapy: Undergo RT"
11055546|NCT01333033|OG001|Outcome|CP Non-Responder|"Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases >= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT>~>>>~>~>>> Carboplatin: Given IV>~>>>~>~>>> Paclitaxel: Given IV>~>>>~>~>>> Radiation Therapy: Undergo RT"
11055547|NCT01333033|OG000|Outcome|FOLFOX Regimen|"Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by >= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.> >> >> >> > >> >> >> Oxaliplatin: Given IV> >> >> >> > >> >> >> Leucovorin Calcium: Given IV> >> >> >> > >> >> >> Fluorouracil: Given IV> >> >> >> > >> >> >> Carboplatin: Given IV> >> >> >> > >> >> >> Paclitaxel: Given IV> >> >> >> > >> >> >> Positron Emission Tomography: Undergo PET/CT scan> >> >> >>~>~>>~>>~>> Computed Tomography: Undergo PET/CT scan>~>>~>>~>>~>~>>~>>~>> Radiation Therapy: Undergo RT"
11055548|NCT01333033|OG001|Outcome|CP (Carboplatin + Paclitaxel + Radiation)|"Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases >= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT>~>>~>>~>>~>~>>~>>~>> Carboplatin: Given IV>~>>~>>~>>~>~>>~>>~>> Paclitaxel: Given IV>~>>~>>~>>~>~>>~>>~>> Radiation Therapy: Undergo RT"
11055549|NCT01333033|OG000|Outcome|FOLFOX Responder|"Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by >= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.> >> >> >> > >> >> >> Oxaliplatin: Given IV> >> >> >> > >> >> >> Leucovorin Calcium: Given IV> >> >> >> > >> >> >> Fluorouracil: Given IV> >> >> >> > >> >> >> Carboplatin: Given IV> >> >> >> > >> >> >> Paclitaxel: Given IV> >> >> >> > >> >> >> Positron Emission Tomography: Undergo PET/CT scan> >> >> >>~>~>>~>>~>> Computed Tomography: Undergo PET/CT scan>~>>~>>~>>~>~>>~>>~>> Radiation Therapy: Undergo RT"
11055550|NCT01333033|OG001|Outcome|CP (Carboplatin + Paclitaxel + Radiation) Responder|"Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases >= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT>~>>~>>~>>~>~>>~>>~>> Carboplatin: Given IV>~>>~>>~>>~>~>>~>>~>> Paclitaxel: Given IV>~>>~>>~>>~>~>>~>>~>> Radiation Therapy: Undergo RT"
11055551|NCT01333033|OG000|Outcome|FOLFOX Regimen Non-Responders|"Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by >= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.> >>>~>~>>> Oxaliplatin: Given IV>~>>>~>~>>> Leucovorin Calcium: Given IV>~>>>~>~>>> Fluorouracil: Given IV>~>>>~>~>>> Carboplatin: Given IV>~>>>~>~>>> Paclitaxel: Given IV>~>>>~>~>>> Positron Emission Tomography: Undergo PET/CT scan>~>>>~>~>>> Computed Tomography: Undergo PET/CT scan>~>>>~>~>>> Radiation Therapy: Undergo RT"
11055552|NCT01333033|OG001|Outcome|CP (Carboplatin + Paclitaxel + Radiation) Non-Responders|"Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases >= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT>~>>>~>~>>> Carboplatin: Given IV>~>>>~>~>>> Paclitaxel: Given IV>~>>>~>~>>> Radiation Therapy: Undergo RT"
11055553|NCT01333033|OG000|Outcome|FOLFOX Regimen Non-Responder|"Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by >= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.~>~>>~>~>~>>~> Oxaliplatin: Given IV~>~>>~>~>~>>~> Leucovorin Calcium: Given IV~>~>>~>~>~>>~> Fluorouracil: Given IV~>~>>~>~>~>>~> Carboplatin: Given IV~>~>>~>~>~>>~> Paclitaxel: Given IV~>~>>~>~>~>>~> Positron Emission Tomography: Undergo PET/CT scan~>~>>~>~>~>>~> Computed Tomography: Undergo PET/CT scan~>~>>~>~>~>>~> Radiation Therapy: Undergo RT"
11055554|NCT01333033|OG001|Outcome|CP Non-Responder|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT
11055555|NCT01333033|EG000|Reported Event|FOLFOX Responder|Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by >= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks.
11055556|NCT01333033|EG001|Reported Event|FOLFOX Non-Responder|Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.n Emission Tomography: Undergo PET/CT scan
11149397|NCT01870726|EG004|Reported Event|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 500mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib.
11149398|NCT01870726|EG005|Reported Event|300 mg BID Tab+ 80 mg QD|Phase Ib: The combination of 300mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib.
11149399|NCT01870726|EG006|Reported Event|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib.
11055557|NCT01333033|EG002|Reported Event|CP Responder|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases >= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
11055558|NCT01333033|EG003|Reported Event|CP Non-Responder|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases >= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
11055559|NCT01333033|EG004|Reported Event|CP No Cross-over|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses.
11055560|NCT01333033|EG005|Reported Event|FOLFOX No Cross-over|Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses.
11055561|NCT01333059|BG000|Baseline|Experimental Group|"In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.~At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.~Dosing was done per standard of care and not prescribed per protocol."
11055562|NCT01333059|BG001|Baseline|Control Group|"In this arm, midazolam and fentanyl were administered during cycling.~At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.~Dosing was done per standard of care and not prescribed per protocol."
11055563|NCT01333059|BG002|Baseline|Total|Total of all reporting groups
11055564|NCT01333059|FG000|Participant Flow|Experimental Group|"In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.~At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.~Dosing was done per standard of care and not prescribed per protocol."
11055565|NCT01333059|FG001|Participant Flow|Control Group|"In this arm, midazolam and fentanyl were administered during cycling.~At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.~Dosing was done per standard of care and not prescribed per protocol."
11055566|NCT01333059|OG000|Outcome|Experimental Group|"In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.~At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.~Dosing was done per standard of care and not prescribed per protocol."
11055567|NCT01333059|OG001|Outcome|Control Group|"In this arm, midazolam and fentanyl were administered during cycling.~At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.~Dosing was done per standard of care and not prescribed per protocol."
11149400|NCT01870726|EG007|Reported Event|All Patients (Phase Ib)|Phase Ib: All Patients with the combination of INC280 (BID) and Buparlisib (QD) once daily.
11149401|NCT01870726|EG008|Reported Event|400 mg BID Tab|Phase II: 400mg INC280 (BID) tablet in Phase II.
11149402|NCT01870726|EG009|Reported Event|All Patients (Phase II)|Phase II: All patients treated with INC280 (BID) tablet once daily in the Phase II.
11149403|NCT01870739|BG000|Baseline|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
11055568|NCT01333059|OG000|Outcome|Experimental Group|"In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol."
11055569|NCT01333059|OG001|Outcome|Control Group|"In this arm, midazolam and fentanyl were administered during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol."
11055570|NCT01333059|EG000|Reported Event|Experimental Group|"In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol."
11055571|NCT01333059|EG001|Reported Event|Control Group|"In this arm, midazolam and fentanyl were administered during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled Study Drug M which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled Study Drug F, which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol."
11055572|NCT01333072|BG000|Baseline|Risperidone|"Atypical antipsychotic~Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002)."
11055573|NCT01333072|BG001|Baseline|Aripiprazole|"Atypical antipsychotic~Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks."
11055574|NCT01333072|BG002|Baseline|Total|Total of all reporting groups
11055575|NCT01333072|FG000|Participant Flow|Risperidone|"Atypical antipsychotic~Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day."
11055576|NCT01333072|FG001|Participant Flow|Aripiprazole|"Atypical antipsychotic~Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks."
11055577|NCT01333072|OG000|Outcome|Risperidone|"Atypical antipsychotic~Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002)."
11055578|NCT01333072|OG001|Outcome|Aripiprazole|"Atypical antipsychotic~Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks."
11055579|NCT01333072|EG000|Reported Event|Risperidone|"Atypical antipsychotic~Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002)."
11055580|NCT01333072|EG001|Reported Event|Aripiprazole|"Atypical antipsychotic~Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks."
11055581|NCT01333098|BG000|Baseline|Mifepristone|"1 week mifepristone or placebo followed by 3 weeks open label mifepristone~Mifepristone: 300mg per day, by mouth, for 21-28 days"
11149404|NCT01870739|BG001|Baseline|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
11149405|NCT01870739|BG002|Baseline|Total|Total of all reporting groups
11149406|NCT01870739|FG000|Participant Flow|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
11149407|NCT01870739|FG001|Participant Flow|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
11149408|NCT01870739|OG000|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
11149409|NCT01870739|OG001|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
11149410|NCT01870739|OG000|Outcome|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
11149411|NCT01870739|OG001|Outcome|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
11149412|NCT01870739|OG002|Outcome|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
11149413|NCT01870739|OG003|Outcome|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
11149414|NCT01870739|OG004|Outcome|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
11149415|NCT01870739|OG005|Outcome|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
11149416|NCT01870739|EG000|Reported Event|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
11149417|NCT01870739|EG001|Reported Event|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
11149418|NCT01870739|EG002|Reported Event|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
11149419|NCT01870739|EG003|Reported Event|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
11149420|NCT01870739|EG004|Reported Event|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
11149421|NCT01870739|EG005|Reported Event|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
11149422|NCT01870778|BG000|Baseline|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
11149423|NCT01870778|BG001|Baseline|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
11149424|NCT01870778|BG002|Baseline|Total|Total of all reporting groups
11149425|NCT01870778|FG000|Participant Flow|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
11149426|NCT01870778|FG001|Participant Flow|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
11149427|NCT01870778|OG000|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
11149428|NCT01870778|OG001|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
11149429|NCT01870778|EG000|Reported Event|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
11149430|NCT01870778|EG001|Reported Event|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
11149431|NCT01870843|BG000|Baseline|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
11149432|NCT01870843|FG000|Participant Flow|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
11149433|NCT01870843|OG000|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
11149434|NCT01870843|EG000|Reported Event|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
11149435|NCT01870856|BG000|Baseline|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
11149436|NCT01870856|BG001|Baseline|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
11149437|NCT01870856|BG002|Baseline|Total|Total of all reporting groups
11149438|NCT01870856|FG000|Participant Flow|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
11149439|NCT01870856|FG001|Participant Flow|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
11149440|NCT01870856|OG000|Outcome|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
11149441|NCT01870856|OG001|Outcome|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
11055582|NCT01333098|FG000|Participant Flow|Mifepristone|"1 week mifepristone or placebo, followed by 3 weeks open label mifepristone~Mifepristone: 300mg per day, by mouth, for 21-28 days"
11055583|NCT01333098|OG000|Outcome|Mifepristone|"1 week mifepristone or placebo, followed by 3 weeks open label mifepristone~Mifepristone: 300mg per day, by mouth, for 21-28 days"
11055584|NCT01333098|OG000|Outcome|High Baseline Cortisol|baseline peak cortisol >6 ng/ml
11055585|NCT01333098|OG001|Outcome|Without High Baseline Corisol|baseline peak cortisol <6 ng/ml
11055586|NCT01333098|EG000|Reported Event|Mifepristone|"1 week mifepristone or placebo (followed by 3 weeks open label mifepristone)~Mifepristone: 300mg per day, by mouth, for 21-28 days"
11055587|NCT01333111|BG000|Baseline|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055588|NCT01333111|BG001|Baseline|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055589|NCT01333111|BG002|Baseline|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055590|NCT01333111|BG003|Baseline|Total|Total of all reporting groups
11055591|NCT01333111|FG000|Participant Flow|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055592|NCT01333111|FG001|Participant Flow|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055593|NCT01333111|FG002|Participant Flow|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055594|NCT01333111|OG000|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055595|NCT01333111|OG001|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055596|NCT01333111|OG000|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055597|NCT01333111|EG000|Reported Event|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055598|NCT01333111|EG001|Reported Event|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11055599|NCT01333111|EG002|Reported Event|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
11066778|NCT01393964|EG000|Reported Event|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
11055600|NCT01333189|BG000|Baseline|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
11055601|NCT01333189|BG001|Baseline|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
11055602|NCT01333189|BG002|Baseline|Total|Total of all reporting groups
11055603|NCT01333189|FG000|Participant Flow|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
11055604|NCT01333189|FG001|Participant Flow|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
11055605|NCT01333189|OG000|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
11055606|NCT01333189|OG001|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
11055607|NCT01333189|EG000|Reported Event|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
11055608|NCT01333189|EG001|Reported Event|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
11149442|NCT01870856|OG000|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
11149443|NCT01870856|OG001|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
11055609|NCT01333397|BG000|Baseline|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055610|NCT01333397|BG001|Baseline|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055611|NCT01333397|BG002|Baseline|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055612|NCT01333397|BG003|Baseline|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055613|NCT01333397|BG004|Baseline|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055614|NCT01333397|BG005|Baseline|Total|Total of all reporting groups
11055615|NCT01333397|FG000|Participant Flow|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055616|NCT01333397|FG001|Participant Flow|Dysport NG 20 U|"Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)~Ready to Use (RU)"
11055617|NCT01333397|FG002|Participant Flow|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055618|NCT01333397|FG003|Participant Flow|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055619|NCT01333397|FG004|Participant Flow|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055620|NCT01333397|OG000|Outcome|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055621|NCT01333397|OG001|Outcome|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055622|NCT01333397|OG002|Outcome|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055623|NCT01333397|OG003|Outcome|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055624|NCT01333397|OG000|Outcome|Placebo|
11055625|NCT01333397|OG001|Outcome|Dysport NG 20 U|
11055626|NCT01333397|OG002|Outcome|Dysport NG 50 U|
11055627|NCT01333397|OG003|Outcome|Dysport NG 75 U|
11055628|NCT01333397|OG004|Outcome|Dysport 50 U|
11055629|NCT01333397|OG000|Outcome|Dysport NG 20 U|
11055630|NCT01333397|OG001|Outcome|Dysport NG 50 U|
11055631|NCT01333397|OG002|Outcome|Dysport NG 75 U|
11055632|NCT01333397|OG003|Outcome|Dysport 50 U|
11055633|NCT01333397|OG001|Outcome|Dysport 50 U|
11055634|NCT01333397|EG000|Reported Event|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055635|NCT01333397|EG001|Reported Event|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055636|NCT01333397|EG002|Reported Event|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055637|NCT01333397|EG003|Reported Event|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11055638|NCT01333397|EG004|Reported Event|Dysport 50 U|Botulinum type A toxin ((Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
11149444|NCT01870856|EG000|Reported Event|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
11055639|NCT01333475|BG000|Baseline|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055640|NCT01333475|BG001|Baseline|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055641|NCT01333475|BG002|Baseline|Total|Total of all reporting groups
11055642|NCT01333475|FG000|Participant Flow|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055643|NCT01333475|FG001|Participant Flow|TAC1A|"Cycle = 28 days:MK-2206:135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055644|NCT01333475|OG000|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055645|NCT01333475|OG001|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055646|NCT01333475|OG001|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055647|NCT01333475|EG000|Reported Event|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055648|NCT01333475|EG001|Reported Event|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
11055649|NCT01333488|BG000|Baseline|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
11055650|NCT01333488|BG001|Baseline|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
11055651|NCT01333488|BG002|Baseline|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
11055652|NCT01333488|BG003|Baseline|Total|Total of all reporting groups
11055653|NCT01333488|FG000|Participant Flow|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
11055654|NCT01333488|FG001|Participant Flow|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
11055655|NCT01333488|FG002|Participant Flow|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
11055656|NCT01333488|OG000|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
11055657|NCT01333488|OG001|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
11055658|NCT01333488|OG002|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
11055659|NCT01333488|OG000|Outcome|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
11055660|NCT01333488|EG000|Reported Event|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
11055661|NCT01333488|EG001|Reported Event|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
11055662|NCT01333488|EG002|Reported Event|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
11055663|NCT01333501|BG000|Baseline|Fingolimod|0.5 mg in capsules for oral administration once daily
11055664|NCT01333501|BG001|Baseline|Interferon Beta 1b|250 μg injected s.c. every other day
11055665|NCT01333501|BG002|Baseline|Total|Total of all reporting groups
11055666|NCT01333501|FG000|Participant Flow|Fingolimod|0.5 mg in capsules for oral administration once daily
11055667|NCT01333501|FG001|Participant Flow|Interferon Beta 1b|250 μg injected s.c. every other day
11055668|NCT01333501|OG000|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
11055669|NCT01333501|OG001|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
11055670|NCT01333501|EG000|Reported Event|Fingolimod 0.5 mg|0.5 mg in capsules for oral administration once daily
11055671|NCT01333501|EG001|Reported Event|Interferon Beta 1b|250 μg injected s.c. every other day
11055672|NCT01333527|BG000|Baseline|Group A (Early ROM)|Group A (early ROM) used the sling for comfort only
11055673|NCT01333527|BG001|Baseline|Group B (Usual Care)|Group B (usual care) used the sling for 6 weeks
11055674|NCT01333527|BG002|Baseline|Total|Total of all reporting groups
11055675|NCT01333527|FG000|Participant Flow|Group A (Early ROM)|"Group A (early ROM) will use the sling for comfort only~No Sling: Early range of motion"
11055676|NCT01333527|FG001|Participant Flow|Group B (Usual Care)|"Group B (usual care) will be immobilized in a sling for 6 weeks.~Sling: Patients will use the sling for 6 weeks, as per usual care"
11055677|NCT01333527|OG000|Outcome|Group A (Early ROM)|"Group A (early ROM) will use the sling for comfort only~No Sling: Early range of motion~Overall number of Baseline participants: 103. >18 years, continuous Sex: male and female Region of enrollment"
11055678|NCT01333527|OG001|Outcome|Group B (Usual Care)|"Group B (usual care) will be immobilized in a sling for 6 weeks.~Sling: Patients will use the sling for 6 weeks, as per usual care~Overall number of Baseline participants 103 >18 years, continuous Sex: male and female Region of enrollment"
11055679|NCT01333527|EG000|Reported Event|Group A (Early ROM)|"Group A (early ROM) will use the sling for comfort only~No Sling: Early range of motion~Overall number of Baseline participants: 103. >18 years, continuous Sex: male and female Region of enrollment"
11055680|NCT01333527|EG001|Reported Event|Group B (Usual Care)|"Group B (usual care) will be immobilized in a sling for 6 weeks.~Sling: Patients will use the sling for 6 weeks, as per usual care~Overall number of Baseline participants 103 >18 years, continuous Sex: male and female Region of enrollment"
11055681|NCT01333592|BG000|Baseline|KAD-1229 / DPP-4 Inhibitors|
11055682|NCT01333592|BG001|Baseline|KAD-1229 / Biguanides|
11055683|NCT01333592|BG002|Baseline|Total|Total of all reporting groups
11055684|NCT01333592|FG000|Participant Flow|KAD-1229 / DPP-4 Inhibitors|
11055685|NCT01333592|FG001|Participant Flow|KAD-1229 / Biguanides|
11055686|NCT01333592|OG000|Outcome|KAD-1229 / DPP-4 Inhibitors|
11055687|NCT01333592|OG001|Outcome|KAD-1229 / Biguanides|
11055688|NCT01333592|EG000|Reported Event|KAD-1229 / DPP-4 Inhibitors|
11055689|NCT01333592|EG001|Reported Event|KAD-1229 / Biguanides|
11055690|NCT01333722|BG000|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
11055691|NCT01333722|BG001|Baseline|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
11055692|NCT01333722|BG002|Baseline|Total|Total of all reporting groups
11055693|NCT01333722|FG000|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
11055694|NCT01333722|FG001|Participant Flow|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
11055695|NCT01333722|OG000|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
11055696|NCT01333722|OG001|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
11055697|NCT01333722|OG000|Outcome|Hydrocodone/Acetaminophen Extended Release|hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
11055698|NCT01333722|OG001|Outcome|Placebo|placebo, 1 oral tablet every 12 hours
11055699|NCT01333722|EG000|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
11055700|NCT01333722|EG001|Reported Event|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
11055701|NCT01333813|BG000|Baseline|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
11055702|NCT01333813|FG000|Participant Flow|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
11055703|NCT01333813|OG000|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
11055704|NCT01333813|EG000|Reported Event|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
11055705|NCT01333865|BG000|Baseline|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
11055706|NCT01333865|FG000|Participant Flow|Memantine (Namenda) Treatment|"Memantine: Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
11055707|NCT01333865|OG000|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
11055708|NCT01333865|EG000|Reported Event|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
11055709|NCT01333956|BG000|Baseline|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055710|NCT01333956|BG001|Baseline|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055711|NCT01333956|BG002|Baseline|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055712|NCT01333956|BG003|Baseline|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055713|NCT01333956|BG004|Baseline|Total|Total of all reporting groups
11055714|NCT01333956|FG000|Participant Flow|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose."
11055715|NCT01333956|FG001|Participant Flow|50mg Arm|Patients will receive 50mg of pregabalin per dose.
11055716|NCT01333956|FG002|Participant Flow|100mg Arm|Patients will receive 100mg of pregabalin per dose.
11055717|NCT01333956|FG003|Participant Flow|150mg Arm|Patients will receive 150mg of pregabalin per dose.
11055718|NCT01333956|OG000|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16."
11055719|NCT01333956|OG001|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11149445|NCT01870856|EG001|Reported Event|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
11149446|NCT01870869|BG000|Baseline|Augmentation|Women who had breast augmentation with NATRELLE® 410 implants.
11055720|NCT01333956|OG002|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055721|NCT01333956|OG003|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055722|NCT01333956|OG000|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055723|NCT01333956|EG000|Reported Event|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055724|NCT01333956|EG001|Reported Event|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055725|NCT01333956|EG002|Reported Event|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055726|NCT01333956|EG003|Reported Event|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
11055727|NCT01334086|BG000|Baseline|Aprepitant|Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
11055728|NCT01334086|FG000|Participant Flow|Aprepitant|Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
11055729|NCT01334086|OG000|Outcome|Aprepitant|Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
11055730|NCT01334086|EG000|Reported Event|Aprepitant|Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
11055731|NCT01334125|BG000|Baseline|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
11055732|NCT01334125|BG001|Baseline|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsules once daily by mouth for 9 months"
11055733|NCT01334125|BG002|Baseline|Total|Total of all reporting groups
11055734|NCT01334125|FG000|Participant Flow|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
11055735|NCT01334125|FG001|Participant Flow|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
11055736|NCT01334125|OG000|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
11055737|NCT01334125|OG001|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsules once daily by mouth for 9 months"
11055738|NCT01334125|OG001|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
11055739|NCT01334125|EG000|Reported Event|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
11055740|NCT01334125|EG001|Reported Event|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
11055741|NCT01334216|BG000|Baseline|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
11055742|NCT01334216|BG001|Baseline|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
11055743|NCT01334216|BG002|Baseline|Total|Total of all reporting groups
11055744|NCT01334216|FG000|Participant Flow|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
11055745|NCT01334216|FG001|Participant Flow|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
11055746|NCT01334216|OG000|Outcome|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
11055747|NCT01334216|OG001|Outcome|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
11055748|NCT01334216|EG000|Reported Event|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
11055749|NCT01334216|EG001|Reported Event|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
11055750|NCT01334229|BG000|Baseline|Sitagliptin First Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Pacebo for 6 weeks
11055751|NCT01334229|BG001|Baseline|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
11055752|NCT01334229|BG002|Baseline|Total|Total of all reporting groups
11055753|NCT01334229|FG000|Participant Flow|Sitagliptin Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Placebo for 6 weeks
11055754|NCT01334229|FG001|Participant Flow|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
11055755|NCT01334229|OG000|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
11055756|NCT01334229|OG001|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
11055757|NCT01334229|EG000|Reported Event|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
11055758|NCT01334229|EG001|Reported Event|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
11055759|NCT01334515|BG000|Baseline|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
11055760|NCT01334515|BG001|Baseline|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
11055761|NCT01334515|BG002|Baseline|Total|Total of all reporting groups
11055762|NCT01334515|FG000|Participant Flow|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
11055763|NCT01334515|FG001|Participant Flow|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
11055764|NCT01334515|OG000|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
11055765|NCT01334515|OG001|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
11055766|NCT01334515|EG000|Reported Event|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
11149447|NCT01870869|BG001|Baseline|Revision-Augmentation|Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
11149448|NCT01870869|BG002|Baseline|Reconstruction|Women who had breast reconstruction with NATRELLE® 410 implants.
11149449|NCT01870869|BG003|Baseline|Revision-Reconstruction|Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
11055767|NCT01334515|EG001|Reported Event|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
11055768|NCT01334554|BG000|Baseline|Sildenafil|Sildenafil 20 mg three times a day for 4 weeks
11055769|NCT01334554|BG001|Baseline|Placebo|Placebo three times a day for 4 weeks
11055770|NCT01334554|BG002|Baseline|Total|Total of all reporting groups
11149450|NCT01870869|BG004|Baseline|Total|Total of all reporting groups
11149451|NCT01870869|FG000|Participant Flow|Augmentation|Women who had breast augmentation with NATRELLE® 410 implants.
11149452|NCT01870869|FG001|Participant Flow|Revision-Augmentation|Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
11149453|NCT01870869|FG002|Participant Flow|Reconstruction|Women who had breast reconstruction with NATRELLE® 410 implants.
11149454|NCT01870869|FG003|Participant Flow|Revision-Reconstruction|Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
11149455|NCT01870869|OG000|Outcome|Augmentation|Women who had breast augmentation with NATRELLE® 410 implants.
11149456|NCT01870869|OG001|Outcome|Revision-Augmentation|Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
11149457|NCT01870869|OG002|Outcome|Reconstruction|Women who had breast reconstruction with NATRELLE® 410 implants.
11149458|NCT01870869|OG003|Outcome|Revision-Reconstruction|Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
11149459|NCT01870869|EG000|Reported Event|Augmentation|Women who had breast augmentation with NATRELLE® 410 implants.
11149460|NCT01870869|EG001|Reported Event|Revision-Augmentation|Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
11149461|NCT01870869|EG002|Reported Event|Reconstruction|Women who had breast reconstruction with NATRELLE® 410 implants.
11149462|NCT01870869|EG003|Reported Event|Revision-Reconstruction|Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
11149463|NCT01870921|BG000|Baseline|Ticargrelor|90 mg/tablet, 1 tablet bid
11149464|NCT01870921|FG000|Participant Flow|Ticargrelor|90 mg/tablet, 1 tablet bid
11149465|NCT01870921|OG000|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
11149466|NCT01870921|EG000|Reported Event|Ticargrelor|90 mg/tablet, 1 tablet bid
11149467|NCT01870973|BG000|Baseline|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
11149468|NCT01870973|BG001|Baseline|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
11149469|NCT01870973|BG002|Baseline|Total|Total of all reporting groups
11149470|NCT01870973|FG000|Participant Flow|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
11149471|NCT01870973|FG001|Participant Flow|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
11149472|NCT01870973|OG000|Outcome|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
11149473|NCT01870973|OG001|Outcome|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
11149474|NCT01870973|EG000|Reported Event|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
11149475|NCT01870973|EG001|Reported Event|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
11149476|NCT01870999|BG000|Baseline|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149477|NCT01870999|BG001|Baseline|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11055771|NCT01334554|FG000|Participant Flow|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
11055772|NCT01334554|FG001|Participant Flow|Placebo|Participants received placebo three times a day for 4 weeks
11055773|NCT01334554|OG000|Outcome|Sildenafil|Sildenafil: 20 mg TID
11055774|NCT01334554|OG001|Outcome|Placebo|Placebo tablets, 1 tablet three times a day
11055775|NCT01334554|OG000|Outcome|Sildenafil|"Sildenafil 20 mg three times a day~Sildenafil: 20 mg three times a day."
11055776|NCT01334554|OG001|Outcome|Placebo|"placebo~Placebo: No active drug"
11055777|NCT01334554|EG000|Reported Event|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
11055778|NCT01334554|EG001|Reported Event|Placebo|Participants received placebo three times a day for 4 weeks
11055779|NCT01334710|BG000|Baseline|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
11055780|NCT01334710|FG000|Participant Flow|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
11055781|NCT01334710|OG000|Outcome|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
11055782|NCT01334710|OG000|Outcome|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906: Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
11055783|NCT01334710|EG000|Reported Event|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
11055784|NCT01334723|BG000|Baseline|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
11055785|NCT01334723|BG001|Baseline|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
11055786|NCT01334723|BG002|Baseline|Total|Total of all reporting groups
11055787|NCT01334723|FG000|Participant Flow|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
11055788|NCT01334723|FG001|Participant Flow|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
11055789|NCT01334723|OG000|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=70%|Participants in the acute urinary retention outcomes cohort with an MPR <=70%
11055790|NCT01334723|OG001|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >70%|Participants in the acute urinary retention outcomes cohort with an MPR >70%
11055791|NCT01334723|OG002|Outcome|Prostate Surgery Outcomes Cohort, MPR <=70%|Participants in the prostate surgery outcomes cohort with an MPR <=70%
11055792|NCT01334723|OG003|Outcome|Prostate Surgery Outocomes Cohort, MPR >70%|Participants in the prostate surgery outcomes cohort with an MPR >70%
11055793|NCT01334723|OG000|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=75%|Among the Participants in the acute urinary retention outcomes cohort with an MPR <=75%
11055794|NCT01334723|OG001|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >75%|Participants in the acute urinary retention outcomes cohort with an MPR >75%
11055795|NCT01334723|OG002|Outcome|Prostate Surgery Outcomes Cohort, MPR <=75%|Participants in the prostate surgery outcomes cohort with an MPR <=75%
11055796|NCT01334723|OG003|Outcome|Prostate Surgery Outcomes Cohort, MPR >75%|Participants in the prostate surgery outcomes cohort with an MPR >75%
11055797|NCT01334723|OG000|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=80%|Participants in the acute urinary retention outcomes cohort with an MPR <=80%
11055798|NCT01334723|OG001|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >80%|Participants in the acute urinary retention outcomes cohort with an >80%
11055799|NCT01334723|OG002|Outcome|Prostate Surgery Outcomes Cohort, MPR <=80%|Participants in the prostate surgery outcomes cohort with an MPR <=80%
11055800|NCT01334723|OG003|Outcome|Prostate Surgery Outcomes Cohort, MPR >80%|Participants in the prostate surgery outcomes cohort with an MPR >80%
11055801|NCT01334723|OG000|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
11055802|NCT01334723|OG001|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
11055803|NCT01334723|EG000|Reported Event|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
11055804|NCT01334723|EG001|Reported Event|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
11055805|NCT01334827|BG000|Baseline|Female Member of Couple Enrolled|Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
11055806|NCT01334827|BG001|Baseline|Male Member of Couple Enrolled|Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
11055807|NCT01334827|BG002|Baseline|Total|Total of all reporting groups
11055808|NCT01334827|FG000|Participant Flow|Female and Male Members of Monogamous Couples|Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
11055809|NCT01334827|OG000|Outcome|Female Members|Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
11055810|NCT01334827|OG001|Outcome|Male Members|Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
11055811|NCT01334827|EG000|Reported Event|Females|Female member of couple enrolled
11055812|NCT01334827|EG001|Reported Event|Males|Male member of couple enrolled
11055813|NCT01334866|BG000|Baseline|Study Completion Cohort|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
11055814|NCT01334866|FG000|Participant Flow|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
11055815|NCT01334866|OG000|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
11055816|NCT01334866|OG000|Outcome|Study Procedure Cohort|89 Subjects received study treatment
11055817|NCT01334866|OG000|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
11055818|NCT01334866|EG000|Reported Event|Study Procedure Cohort|89 Subjects received study treatment
11055819|NCT01334918|BG000|Baseline|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.~Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.~Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
11055820|NCT01334918|BG001|Baseline|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.~Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
11055821|NCT01334918|BG002|Baseline|Total|Total of all reporting groups
11055822|NCT01334918|FG000|Participant Flow|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.~Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.~Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
11055823|NCT01334918|FG001|Participant Flow|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.~Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
11055824|NCT01334918|OG000|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
11055825|NCT01334918|OG001|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
11055826|NCT01334918|OG002|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
11055827|NCT01334918|OG000|Outcome|SPECT: Reviewer 1|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 1.
11055828|NCT01334918|OG001|Outcome|SPECT: Reviewer 2|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 2.
11055829|NCT01334918|OG002|Outcome|SPECT: Reviewer 3|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 3.
11055830|NCT01334918|OG003|Outcome|MDCT: Reviewer 1|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
11055831|NCT01334918|OG004|Outcome|MDCT: Reviewer 2|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
11055832|NCT01334918|OG005|Outcome|MDCT: Reviewer 3|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
11055833|NCT01334918|OG000|Outcome|CTP: 0 Fixed Defects|Participants with zero fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
11055834|NCT01334918|OG001|Outcome|CTP: ≥ 1 Fixed Defects|Participants with ≥ 1 fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
11055835|NCT01334918|OG002|Outcome|CTP: All Fixed Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
11055836|NCT01334918|OG000|Outcome|SPECT + MDCT|Participants underwent both a rest and stress SPECT series and a rest and stress MDCT series.
11055837|NCT01334918|EG000|Reported Event|SPECT|Resting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
11055838|NCT01334918|EG001|Reported Event|MDCT|Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
11055839|NCT01334944|BG000|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.~Intravenous ibuprofen: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
11055840|NCT01334944|FG000|Participant Flow|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
11055841|NCT01334944|FG001|Participant Flow|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
11055842|NCT01334944|OG000|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
11055843|NCT01334944|OG001|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
11055844|NCT01334944|OG000|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
11055845|NCT01334944|OG001|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
11055846|NCT01334944|OG000|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
11055847|NCT01334944|EG000|Reported Event|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
11055848|NCT01334944|EG001|Reported Event|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
11055849|NCT01334957|BG000|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
11055850|NCT01334957|FG000|Participant Flow|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
11055851|NCT01334957|OG000|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
11055852|NCT01334957|EG000|Reported Event|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
11055853|NCT01335009|BG000|Baseline|MORAb-004 2 mg/kg|Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
11055854|NCT01335009|BG001|Baseline|MORAb-004 4 mg/kg|Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
11055855|NCT01335009|BG002|Baseline|Total|Total of all reporting groups
11055856|NCT01335009|FG000|Participant Flow|MORAb-004 2 mg/kg|Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using computed tomography/magnetic resonance imaging (CT/MRI) or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
11055857|NCT01335009|FG001|Participant Flow|MORAb-004 4 mg/kg|Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
11055858|NCT01335009|OG000|Outcome|MORAb-004 2 mg/kg|Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
11055859|NCT01335009|OG001|Outcome|MORAb-004 4 mg/kg|Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
11055860|NCT01335009|EG000|Reported Event|MORAb-004 2 mg/kg|Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
11055861|NCT01335009|EG001|Reported Event|MORAb-004 4 mg/kg|Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
11055862|NCT01335061|BG000|Baseline|All Participants|The data for all the participants is presented.
11055863|NCT01335061|FG000|Participant Flow|All Participants|The data for all the participants is presented.
11055864|NCT01335061|OG000|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
11055865|NCT01335061|OG001|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100 IU/kg once weekly was initiated at Visit 4.
11055866|NCT01335061|OG000|Outcome|On-Demand Therapy-First Infusion|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
11055867|NCT01335061|OG001|Outcome|On-Demand Therapy-Follow-up Infusions|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
11055868|NCT01335061|OG000|Outcome|All Population|The data for all the participants is presented.
11055869|NCT01335061|OG000|Outcome|All Participants|The data for all the participants is presented.
11055870|NCT01335061|OG001|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
11055871|NCT01335061|EG000|Reported Event|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
11341967|NCT03694197|FG000|Participant Flow|Alirocumab 75 Q2W/Up150 Q2W|All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
11055872|NCT01335061|EG001|Reported Event|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
11055873|NCT01335191|BG000|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
11055874|NCT01335191|BG001|Baseline|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
11055875|NCT01335191|BG002|Baseline|Total|Total of all reporting groups
11055876|NCT01335191|FG000|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
11055877|NCT01335191|FG001|Participant Flow|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
11055878|NCT01335191|OG000|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
11055879|NCT01335191|OG001|Outcome|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
11055880|NCT01335191|EG000|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
11055881|NCT01335191|EG001|Reported Event|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
11055882|NCT01335204|BG000|Baseline|Cabazitaxel Plus Bavituximab|"Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.~Cabazitaxel plus bavituximab: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles."
11055883|NCT01335204|FG000|Participant Flow|Cabazitaxel Plus Bavituximab|"Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.~Cabazitaxel plus bavituximab: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles."
11055884|NCT01335204|OG000|Outcome|Cabazitaxel Plus Bavituximab|"Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.~Cabazitaxel plus bavituximab: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles."
11055885|NCT01335204|EG000|Reported Event|Cabazitaxel Plus Bavituximab|"Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.~Cabazitaxel plus bavituximab: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles."
11055886|NCT01335230|BG000|Baseline|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
11055887|NCT01335230|BG001|Baseline|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
11055888|NCT01335230|BG002|Baseline|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
11055889|NCT01335230|BG003|Baseline|10 Control Subjects|10 subjects without HIV, HCV, or both
11055890|NCT01335230|BG004|Baseline|Total|Total of all reporting groups
11055891|NCT01335230|FG000|Participant Flow|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
11055892|NCT01335230|FG001|Participant Flow|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
11055893|NCT01335230|FG002|Participant Flow|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
11055894|NCT01335230|FG003|Participant Flow|10 Control Subjects|10 subjects without HIV, HCV, or both
11055895|NCT01335230|OG000|Outcome|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
11055896|NCT01335230|OG001|Outcome|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
11055897|NCT01335230|OG002|Outcome|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
11055898|NCT01335230|OG003|Outcome|10 Control Subjects|10 subjects without HIV, HCV, or both
11055899|NCT01335230|EG000|Reported Event|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
11055900|NCT01335230|EG001|Reported Event|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
11055901|NCT01335230|EG002|Reported Event|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
11055902|NCT01335230|EG003|Reported Event|10 Control Subjects|10 subjects without HIV, HCV, or both
11055903|NCT01335308|BG000|Baseline|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
11055904|NCT01335308|BG001|Baseline|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
11055905|NCT01335308|BG002|Baseline|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
11055906|NCT01335308|BG003|Baseline|Total|Total of all reporting groups
11055907|NCT01335308|FG000|Participant Flow|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
11055908|NCT01335308|FG001|Participant Flow|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
11055909|NCT01335308|FG002|Participant Flow|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
11055910|NCT01335308|OG000|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
11055911|NCT01335308|OG001|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
11055912|NCT01335308|OG002|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
11055913|NCT01335308|EG000|Reported Event|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
11055914|NCT01335308|EG001|Reported Event|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
11055915|NCT01335308|EG002|Reported Event|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
11055916|NCT01335464|BG000|Baseline|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
11055917|NCT01335464|BG001|Baseline|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
11055918|NCT01335464|BG002|Baseline|Total|Total of all reporting groups
11055919|NCT01335464|FG000|Participant Flow|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
11055920|NCT01335464|FG001|Participant Flow|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
11055921|NCT01335464|OG000|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
11055922|NCT01335464|OG001|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
11055923|NCT01335464|EG000|Reported Event|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules.
11055924|NCT01335464|EG001|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
11055925|NCT01335477|BG000|Baseline|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
11055926|NCT01335477|BG001|Baseline|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
11055927|NCT01335477|BG002|Baseline|Total|Total of all reporting groups
11055928|NCT01335477|FG000|Participant Flow|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
11055929|NCT01335477|FG001|Participant Flow|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
11055930|NCT01335477|OG000|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
11055931|NCT01335477|OG001|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
11055932|NCT01335477|EG000|Reported Event|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules.
11055933|NCT01335477|EG001|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
11055934|NCT01335542|BG000|Baseline|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
11055935|NCT01335542|BG001|Baseline|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
11055936|NCT01335542|BG002|Baseline|Total|Total of all reporting groups
11055937|NCT01335542|FG000|Participant Flow|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
11055938|NCT01335542|FG001|Participant Flow|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
11055939|NCT01335542|OG000|Outcome|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
11055940|NCT01335542|OG001|Outcome|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
11055941|NCT01335542|EG000|Reported Event|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
11055942|NCT01335542|EG001|Reported Event|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
11055943|NCT01335620|BG000|Baseline|Truvada Plus Raltegravir|"Single arm study~Raltegravir: 400 mg twice daily"
11055944|NCT01335620|FG000|Participant Flow|Truvada Plus Raltegravir|"Single arm study~Raltegravir: 400 mg twice daily"
11055945|NCT01335620|OG000|Outcome|Truvada Plus Raltegravir|"Single arm study~Raltegravir: 400 mg twice daily"
11055946|NCT01335620|EG000|Reported Event|Truvada Plus Raltegravir|"Single arm study~Raltegravir: 400 mg twice daily"
11055947|NCT01335698|BG000|Baseline|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055948|NCT01335698|BG001|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055949|NCT01335698|BG002|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055950|NCT01335698|BG003|Baseline|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055951|NCT01335698|BG004|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055952|NCT01335698|BG005|Baseline|Total|Total of all reporting groups
11055953|NCT01335698|FG000|Participant Flow|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055954|NCT01335698|FG001|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055955|NCT01335698|FG002|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055956|NCT01335698|FG003|Participant Flow|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055957|NCT01335698|FG004|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055958|NCT01335698|OG000|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055959|NCT01335698|OG001|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055960|NCT01335698|OG002|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055961|NCT01335698|OG003|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055962|NCT01335698|OG004|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055963|NCT01335698|OG001|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055964|NCT01335698|OG002|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
11055965|NCT01335698|EG000|Reported Event|B/L Weight 5 to lt 10kg (ATV 150mg)|
11055966|NCT01335698|EG001|Reported Event|B/L Weight 5 to lt 10kg (ATV 200mg)|
11055967|NCT01335698|EG002|Reported Event|B/L Weight 10 to lt 15kg|
11226700|NCT02377427|FG002|Participant Flow|Part B: Mepolizumab 40 mg SC|Participants with bodyweight < 40 kg received 0.4 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
11226701|NCT02377427|FG003|Participant Flow|Part B: Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
11055968|NCT01335698|EG003|Reported Event|B/L Weight 15 to lt 25kg|
11055969|NCT01335698|EG004|Reported Event|B/L Weight 25 to lt 35kg|
11055970|NCT01335724|BG000|Baseline|Diclofenac Diethylamine 1.16% Gel|
11055971|NCT01335724|BG001|Baseline|Placebo Gel|
11055972|NCT01335724|BG002|Baseline|Total|Total of all reporting groups
11055973|NCT01335724|FG000|Participant Flow|Diclofenac Diethylamine 1.16% Gel|
11055974|NCT01335724|FG001|Participant Flow|Placebo Gel|
11226702|NCT02377427|FG004|Participant Flow|Part B: Mepolizumab 40/100 mg SC|Participants received either 0.4 mL or 1.0 mL of reconstituted mepolizumab depending upon the bodyweight, administered subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. Participants enrolled to <40 kg at Visit 9 (Week 20) were summarized in the 40/100 mg SC group if they had weight >=40 kg at any subsequent visit.
11055975|NCT01335724|OG000|Outcome|Diclofenac Diethylamine 1.16% Gel|
11055976|NCT01335724|OG001|Outcome|Placebo Gel|
11055977|NCT01335724|EG000|Reported Event|Diclofenac Diethylamine 1.16% Gel|
11055978|NCT01335724|EG001|Reported Event|Placebo Gel|
11055979|NCT01335750|BG000|Baseline|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
11055980|NCT01335750|FG000|Participant Flow|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
11055981|NCT01335750|OG000|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
11055982|NCT01335750|OG001|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
11055983|NCT01335750|OG002|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
11055984|NCT01335750|OG003|Outcome|Multipurpose Solution #4|Saline Multipurpose Solution
11055985|NCT01335750|OG003|Outcome|Multipurpose Solution #4|Saline Solution
11055986|NCT01335750|OG000|Outcome|Mutlipurpose Solution #1|Optifree Replenish Multipurpose Solution
11055987|NCT01335750|OG001|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
11055988|NCT01335750|OG003|Outcome|Multipurpose Solution #4|Saline solution
11055989|NCT01335750|OG000|Outcome|Multipurpose Solution #1|Optifree Replenish
11055990|NCT01335750|EG000|Reported Event|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
11055991|NCT01335789|BG000|Baseline|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
11055992|NCT01335789|BG001|Baseline|Saline|"intranasal administration~Saline: 40 IUs"
11055993|NCT01335789|BG002|Baseline|Total|Total of all reporting groups
11055994|NCT01335789|FG000|Participant Flow|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
11055995|NCT01335789|FG001|Participant Flow|Saline|"intranasal administration~Saline: 40 IUs"
11055996|NCT01335789|OG000|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
11055997|NCT01335789|OG001|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
11055998|NCT01335789|EG000|Reported Event|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
11055999|NCT01335789|EG001|Reported Event|Saline|"intranasal administration~Saline: 40 IUs"
11056000|NCT01335867|BG000|Baseline|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
11056001|NCT01335867|BG001|Baseline|Placebo|Placebo: Placebo pills
11056002|NCT01335867|BG002|Baseline|Total|Total of all reporting groups
11056003|NCT01335867|FG000|Participant Flow|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
11056004|NCT01335867|FG001|Participant Flow|Placebo|Placebo: Placebo pills
11056005|NCT01335867|OG000|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 12 weeks
11341968|NCT03694197|OG000|Outcome|Alirocumab 75 Q2W/Up150 Q2W|All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
11056006|NCT01335867|OG001|Outcome|Placebo|Placebo: Placebo pills
11056007|NCT01335867|OG000|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
11056008|NCT01335867|OG000|Outcome|Vigabatrin|vigabatrin 3 grams daily for 12 weeks
11056009|NCT01335867|OG001|Outcome|Placebo|placebo capsules
11056010|NCT01335867|OG000|Outcome|Vigabatrin|"Vigabatrin titrated to 3 grams daily for 12 weeks~Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks"
11056011|NCT01335867|OG001|Outcome|Placebo|"Identical placebo daily for 12 weeks~Placebo: Placebo pills"
11056012|NCT01335867|OG000|Outcome|Vigabatrin|"Vigabatrin titrated to 3 grams daily for 8 weeks~Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks"
11056013|NCT01335867|OG001|Outcome|Placebo|"Identical placebo daily for three weeks~Placebo: Placebo pills"
11056014|NCT01335867|EG000|Reported Event|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
11056015|NCT01335867|EG001|Reported Event|Placebo|Placebo: Placebo pills
11056016|NCT01335932|BG000|Baseline|IV Ganciclovir|"5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge~IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose."
11056017|NCT01335932|BG001|Baseline|Placebo|"normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge~Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."
11056018|NCT01335932|BG002|Baseline|Total|Total of all reporting groups
11056019|NCT01335932|FG000|Participant Flow|IV Ganciclovir|"5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge~IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose."
11056020|NCT01335932|FG001|Participant Flow|Placebo|"normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge~Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."
11056021|NCT01335932|OG000|Outcome|IV Ganciclovir|"5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge~IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose."
11056022|NCT01335932|OG001|Outcome|Placebo|"normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge~Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."
11056023|NCT01335932|EG000|Reported Event|IV Ganciclovir|"5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge~IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose."
11056024|NCT01335932|EG001|Reported Event|Placebo|"normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge~Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."
11056025|NCT01335971|BG000|Baseline|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
11056026|NCT01335971|BG001|Baseline|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
11056027|NCT01335971|BG002|Baseline|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
11056028|NCT01335971|BG003|Baseline|Total|Total of all reporting groups
11056029|NCT01335971|FG000|Participant Flow|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
11056030|NCT01335971|FG001|Participant Flow|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
11056031|NCT01335971|FG002|Participant Flow|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
11056032|NCT01335971|OG000|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
11056033|NCT01335971|OG001|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
11056034|NCT01335971|OG002|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
11056035|NCT01335971|EG000|Reported Event|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
11056036|NCT01335971|EG001|Reported Event|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
11056037|NCT01335971|EG002|Reported Event|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
11056038|NCT01336023|BG000|Baseline|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056039|NCT01336023|BG001|Baseline|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056040|NCT01336023|BG002|Baseline|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056041|NCT01336023|BG003|Baseline|Total|Total of all reporting groups
11056042|NCT01336023|FG000|Participant Flow|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056043|NCT01336023|FG001|Participant Flow|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056044|NCT01336023|FG002|Participant Flow|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056045|NCT01336023|OG000|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056046|NCT01336023|OG001|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056047|NCT01336023|OG002|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056048|NCT01336023|EG000|Reported Event|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056049|NCT01336023|EG001|Reported Event|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056050|NCT01336023|EG002|Reported Event|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
11056051|NCT01336140|BG000|Baseline|Aminophylline|75 mg of intravenous aminophylline.
11056052|NCT01336140|BG001|Baseline|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
11056053|NCT01336140|BG002|Baseline|Total|Total of all reporting groups
11056054|NCT01336140|FG000|Participant Flow|Aminophylline|75 mg of intravenous aminophylline.
11056055|NCT01336140|FG001|Participant Flow|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
11056056|NCT01336140|OG000|Outcome|Aminophylline|75 mg of intravenous aminophylline.
11056057|NCT01336140|OG001|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
11056058|NCT01336140|EG000|Reported Event|Aminophylline|75 mg of intravenous aminophylline.
11056059|NCT01336140|EG001|Reported Event|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
11056060|NCT01336205|BG000|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11056061|NCT01336205|BG001|Baseline|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
11056062|NCT01336205|BG002|Baseline|Total|Total of all reporting groups
11056063|NCT01336205|FG000|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11056064|NCT01336205|FG001|Participant Flow|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
11056065|NCT01336205|OG000|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11056066|NCT01336205|OG001|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
11056067|NCT01336205|EG000|Reported Event|NKTR-118 25 mg|
11056068|NCT01336205|EG001|Reported Event|Usual Care|
11056069|NCT01336296|BG000|Baseline|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
11056070|NCT01336296|BG001|Baseline|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
11056071|NCT01336296|BG002|Baseline|Total|Total of all reporting groups
11056072|NCT01336296|FG000|Participant Flow|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
11056073|NCT01336296|FG001|Participant Flow|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
11056074|NCT01336296|OG000|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
11056075|NCT01336296|OG001|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
11056076|NCT01336296|EG000|Reported Event|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
11056077|NCT01336296|EG001|Reported Event|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
11056078|NCT01336413|BG000|Baseline|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
11056079|NCT01336413|BG001|Baseline|Placebo|Placebo: Same as active comparator, except placebo dispensed.
11056080|NCT01336413|BG002|Baseline|Total|Total of all reporting groups
11056081|NCT01336413|FG000|Participant Flow|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
11056082|NCT01336413|FG001|Participant Flow|Placebo|Placebo: Same as active comparator, except placebo dispensed.
11056083|NCT01336413|OG000|Outcome|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
11056084|NCT01336413|OG001|Outcome|Placebo|Placebo: Same as active comparator, except placebo dispensed.
11056085|NCT01336413|OG000|Outcome|Arm 1|"Pregnenolone~Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial"
11056086|NCT01336413|OG001|Outcome|Arm 2|"Placebo~Placebo: Same as active comparator, except placebo dispensed."
11056087|NCT01336413|EG000|Reported Event|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
11056088|NCT01336413|EG001|Reported Event|Placebo|Placebo: Same as active comparator, except placebo dispensed.
11056089|NCT01336569|BG000|Baseline|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
11056090|NCT01336569|FG000|Participant Flow|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
11056091|NCT01336569|OG000|Outcome|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
11056092|NCT01336569|EG000|Reported Event|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
11056093|NCT01336608|BG000|Baseline|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056094|NCT01336608|BG001|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056095|NCT01336608|BG002|Baseline|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056096|NCT01336608|BG003|Baseline|Total|Total of all reporting groups
11056097|NCT01336608|FG000|Participant Flow|Placebo-Run-in|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
11056098|NCT01336608|FG001|Participant Flow|Placebo QD|Participants received placebo QD in the morning via a dry powder inhaler (DPI) for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056099|NCT01336608|FG002|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 micrograms (µg) inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056100|NCT01336608|FG003|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate (FF)/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056101|NCT01336608|OG000|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056102|NCT01336608|OG001|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056103|NCT01336608|OG002|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056104|NCT01336608|EG000|Reported Event|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056105|NCT01336608|EG001|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056106|NCT01336608|EG002|Reported Event|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
11056107|NCT01336647|BG000|Baseline|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, topically administered to hair and scalp for 10 minutes
11056108|NCT01336647|BG001|Baseline|High-Dose Ha44|High-Dose Ha44 0.74% Gel, topically administered to hair and scalp for 10 minutes
11056109|NCT01336647|BG002|Baseline|Vehicle|Vehicle Gel without active ingredient of Ha44.
11056110|NCT01336647|BG003|Baseline|Total|Total of all reporting groups
11056111|NCT01336647|FG000|Participant Flow|Low Dose Ha 44 Gel|Low-Dose Ha44 Gel 0.37%, it was administered topically for 10 minutes as a single dose.
11056112|NCT01336647|FG001|Participant Flow|High-Dose Ha44|High-Dose Ha44 Gel 0.74% it was administered topically for 10 minutes as a single dose
11056113|NCT01336647|FG002|Participant Flow|Vehicle|Vehicle Ha44 Gel with no active incident it was administered topically for 10 minutes as a single dose.
11056114|NCT01336647|OG000|Outcome|Low Dose Ha44|Ha44 0.37% Gel administered topically to hair and scalp for 10 minutes.
11056115|NCT01336647|OG001|Outcome|Hig Dose Ha44|Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
11056116|NCT01336647|OG002|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
11056117|NCT01336647|OG000|Outcome|Low Dose Ha44|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
11056118|NCT01336647|OG001|Outcome|High Dose Ha44|High-Dose Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
11056119|NCT01336647|EG000|Reported Event|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
11056120|NCT01336647|EG001|Reported Event|High Dose Ha44 Gel|High-Dose Ha44 0.74% Gel, administered topically to hair and scalp for 10 minutes.
11056121|NCT01336647|EG002|Reported Event|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
11056122|NCT01336712|BG000|Baseline|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
11056123|NCT01336712|FG000|Participant Flow|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4~Patient follow up x6 months"
11056124|NCT01336712|OG000|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
11056125|NCT01336712|EG000|Reported Event|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
11056126|NCT01336738|BG000|Baseline|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056127|NCT01336738|BG001|Baseline|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056128|NCT01336738|BG002|Baseline|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056129|NCT01336738|BG003|Baseline|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056130|NCT01336738|BG004|Baseline|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056131|NCT01336738|BG005|Baseline|Total|Total of all reporting groups
11056132|NCT01336738|FG000|Participant Flow|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056133|NCT01336738|FG001|Participant Flow|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056134|NCT01336738|FG002|Participant Flow|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056135|NCT01336738|FG003|Participant Flow|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056136|NCT01336738|FG004|Participant Flow|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056137|NCT01336738|OG000|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056138|NCT01336738|OG001|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056139|NCT01336738|OG002|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056140|NCT01336738|OG003|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056141|NCT01336738|OG004|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056142|NCT01336738|EG000|Reported Event|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11226703|NCT02377427|OG000|Outcome|Part A: Mepolizumab SC|Participants received mepolizumab 40 or 100 mg SC, depending on participant's bodyweight (40 mg for <40 kg and 100 mg for >=40 kg). Participants received 0.4 mL of reconstituted mepolizumab subcutaneously (for 40 mg dose) or 1.0 mL of reconstituted mepolizumab subcutaneously (for 100 mg dose) every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
11056143|NCT01336738|EG001|Reported Event|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056144|NCT01336738|EG002|Reported Event|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056145|NCT01336738|EG003|Reported Event|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056146|NCT01336738|EG004|Reported Event|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056147|NCT01336764|BG000|Baseline|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
11056148|NCT01336764|BG001|Baseline|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
11056149|NCT01336764|BG002|Baseline|Total|Total of all reporting groups
11056150|NCT01336764|FG000|Participant Flow|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
11056151|NCT01336764|FG001|Participant Flow|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
11056152|NCT01336764|OG000|Outcome|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
11056153|NCT01336764|OG001|Outcome|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
11056154|NCT01336764|EG000|Reported Event|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
11056155|NCT01336764|EG001|Reported Event|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
11056156|NCT01336803|BG000|Baseline|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Feraheme: 5 mg Fe/kg by intravenous adminstration~MR Scan: Standard of Care"
11056157|NCT01336803|FG000|Participant Flow|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Feraheme: 5 mg Fe/kg by intravenous adminstration~MR Scan: Standard of Care"
11056158|NCT01336803|OG000|Outcome|Bone Sarcomas|Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.
11056159|NCT01336803|OG001|Outcome|Osteomyelitis|Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.
11056160|NCT01336803|OG000|Outcome|Bone Sarcomas Pre-ferumoxytol & Post-ferumoxytol Contrast|Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) only.
11056161|NCT01336803|OG000|Outcome|Mean T2 * Relaxation Time for Lymphoma Participants|Participants with lymphoma evaluated with ferumoxytol-enhanced MRI
11056162|NCT01336803|OG001|Outcome|Mean T2 * Relaxation Time for Bone Sarcoma Participants|Participants with bone sarcoma, evaluated with ferumoxytol-enhanced MRI
11056163|NCT01336803|OG000|Outcome|Mean Area Density of CD-68-positive TAM in Lymphoma|CD-68-positive tumor-associated macrophages (TAM) assessed in Lymphoma participants
11056164|NCT01336803|OG001|Outcome|Mean Area Density of CD-68-positive TAM in Bone Sarcomas|CD-68-positive Tumor associated macrophages(TAMs)in Bone Sarcomas participants
11056165|NCT01336803|OG000|Outcome|Mean Area Density of CD163-positive TAM in Lymphoma|CD163-positive tumor-associated macrophages (TAM) was assessed in participants with lymphoma
11056166|NCT01336803|OG001|Outcome|Mean Area Density of CD163-positive TAM in Bone Sarcoma|CD163-positive tumor-associated macrophages (TAM) was assessed in participants with bone sarcomas
11056167|NCT01336803|EG000|Reported Event|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Feraheme: 5 mg Fe/kg iv~MR Scan: Standard of Care"
11056168|NCT01336894|BG000|Baseline|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
11056169|NCT01336894|BG001|Baseline|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
11056170|NCT01336894|BG002|Baseline|Total|Total of all reporting groups
11056171|NCT01336894|FG000|Participant Flow|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
11056172|NCT01336894|FG001|Participant Flow|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
11056173|NCT01336894|OG000|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
11056174|NCT01336894|OG001|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
11056175|NCT01336894|EG000|Reported Event|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
11056176|NCT01336894|EG001|Reported Event|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
11056177|NCT01336933|BG000|Baseline|Treatment (Chemotherapy and Enzyme Inhibitor Therapy)|"Cyclophosphamide and vincristine sulfate by IV on day 1, etoposide IV on days 1-3 or by mouth (PO), once a day (QD) on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Patients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.~prednisone: Given PO~cyclophosphamide: Given IV~etoposide: Given PO or IV~vincristine sulfate: Given IV~pralatrexate: Given IV~laboratory biomarker analysis: Correlative studies~comparative genomic hybridization: Correlative studies~gene expression analysis: Correlative studies~nucleic acid sequencing: Correlative studies~mutation analysis"
11056178|NCT01336933|FG000|Participant Flow|Chemotherapy and Enzyme Inhibitor Therapy|"A Treatment: Cyclophosphamide,Etoposide, Vincristine and Prednisone (CEOP) B Treatment: Pralatrexate (P)~A cycles (CEOP) of the treatment regimen are 14 days, followed by  B cycles (P) which are 21 days, followed by 7 days of rest for a total of 42 days per course, unless criteria are met for stopping or holding treatment or to a maximum of 6 courses.~Patients with Complete Response (CR) or Partial Response (PR), per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation."
11056179|NCT01336933|OG000|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor Therapy)|"Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO QD on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Patients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.~prednisone: Given PO~cyclophosphamide: Given IV~etoposide: Given PO or IV~vincristine sulfate: Given IV~pralatrexate: Given IV~laboratory biomarker analysis: Correlative studies~comparative genomic hybridization: Correlative studies~gene expression analysis: Correlative studies~nucleic acid sequencing: Correlative studies~mutation analysis: Correlative studies"
11056180|NCT01336933|OG000|Outcome|Treatment|"A Treatment: Cyclophosphamide,Etoposide, Vincristine and Prednisone (CEOP) B Treatment: Pralatrexate (P)~A cycles (CEOP) of the treatment regimen are 14 days, followed by  B cycles (P) which are 21 days, followed by 7 days of rest for a total of 42 days per course, unless criteria are met for stopping or holding treatment or to a maximum of 6 courses.~Patients with Complete Response (CR) or Partial Response (PR), per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation."
11056181|NCT01336933|EG000|Reported Event|Treatment (Chemotherapy and Enzyme Inhibitor Therapy)|"Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO QD on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Patients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.~prednisone: Given PO~cyclophosphamide: Given IV~etoposide: Given PO or IV~vincristine sulfate: Given IV~pralatrexate: Given IV~laboratory biomarker analysis: Correlative studies~comparative genomic hybridization: Correlative studies~gene expression analysis: Correlative studies~nucleic acid sequencing: Correlative studies~mutation analysis: Correlative studies"
11056182|NCT01336959|BG000|Baseline|Open Label - BCT197|BCT197 Part A
11056183|NCT01336959|BG001|Baseline|Randomized Double-blind BCT197|BCT197 Part B: Randomized Double-blind BCT197
11056184|NCT01336959|BG002|Baseline|Randomized Double-blind BCT 197 Placebo|Placebo: Placebo capsules
11056185|NCT01336959|BG003|Baseline|Total|Total of all reporting groups
11056186|NCT01336959|FG000|Participant Flow|BCT197 Part A|10 mg BCT197 dosed 2 hours prior to surgery
11226704|NCT02377427|OG000|Outcome|Part A: Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
11056187|NCT01336959|FG001|Participant Flow|BCT197 Part B|BCT197 Part B: Randomized Double-blind BCT197. Single dose 50mg capsule given 2 hours prior to surgery
11056188|NCT01336959|FG002|Participant Flow|Placebo Part B|Double-blind randomized Placebo: Placebo capsules matching 50mg BCT197 capsules. Single dose given 2 hours prior to surgery
11056189|NCT01336959|OG000|Outcome|Open Label - BCT197|BCT197 Part A
11056190|NCT01336959|OG001|Outcome|Randomized Double-blind BCT197|BCT197 Part B: Randomized Double-blind BCT197
11056191|NCT01336959|OG002|Outcome|Randomized Double-blind BCT 197 Placebo|Placebo: Placebo capsules
11056192|NCT01336959|OG000|Outcome|BCT197 Part A|10 mg BCT197 dosed 2 hours prior to surgery
11341969|NCT03694197|EG000|Reported Event|Alirocumab 75 Q2W/Up150 Q2W|All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
11056193|NCT01336959|OG001|Outcome|BCT197 Part B|BCT197 Part B: Randomized Double-blind BCT197. Single dose 50mg capsule given 2 hours prior to surgery
11056194|NCT01336959|OG002|Outcome|Placebo Part B|Double-blind randomized Placebo: Placebo capsules matching 50mg BCT197 capsules. Single dose given 2 hours prior to surgery
11056195|NCT01336959|EG000|Reported Event|Open Label - BCT197|BCT197 Part A
11056196|NCT01336959|EG001|Reported Event|Randomized Double-blind BCT197|BCT197 Part B: Randomized Double-blind BCT197
11056197|NCT01336959|EG002|Reported Event|Randomized Double-blind BCT 197 Placebo|Placebo: Placebo capsules
11056198|NCT01336972|BG000|Baseline|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056199|NCT01336972|BG001|Baseline|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056200|NCT01336972|BG002|Baseline|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056201|NCT01336972|BG003|Baseline|Total|Total of all reporting groups
11056202|NCT01336972|FG000|Participant Flow|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056203|NCT01336972|FG001|Participant Flow|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056204|NCT01336972|FG002|Participant Flow|eGFR <30 ml/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056205|NCT01336972|OG000|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056206|NCT01336972|OG001|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056207|NCT01336972|OG002|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
11056208|NCT01336972|OG002|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056209|NCT01336972|EG000|Reported Event|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056210|NCT01336972|EG001|Reported Event|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056211|NCT01336972|EG002|Reported Event|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
11056212|NCT01337050|BG000|Baseline|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056213|NCT01337050|BG001|Baseline|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056214|NCT01337050|BG002|Baseline|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056215|NCT01337050|BG003|Baseline|Total|Total of all reporting groups
11056216|NCT01337050|FG000|Participant Flow|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056217|NCT01337050|FG001|Participant Flow|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056218|NCT01337050|FG002|Participant Flow|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056219|NCT01337050|OG000|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056220|NCT01337050|OG000|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056221|NCT01337050|OG001|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056222|NCT01337050|OG002|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056223|NCT01337050|EG000|Reported Event|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056224|NCT01337050|EG001|Reported Event|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056225|NCT01337050|EG002|Reported Event|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
11056226|NCT01337076|BG000|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
11056227|NCT01337076|FG000|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
11056228|NCT01337076|OG000|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
11056229|NCT01337076|EG000|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
11056230|NCT01337089|BG000|Baseline|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11056231|NCT01337089|FG000|Participant Flow|Nabiximols|Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11056232|NCT01337089|OG000|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11056233|NCT01337089|EG000|Reported Event|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11056234|NCT01337115|BG000|Baseline|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
11056235|NCT01337115|BG001|Baseline|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
11056236|NCT01337115|BG002|Baseline|Total|Total of all reporting groups
11056237|NCT01337115|FG000|Participant Flow|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
11056238|NCT01337115|FG001|Participant Flow|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
11056239|NCT01337115|OG000|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
11056240|NCT01337115|OG001|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
11056241|NCT01337115|OG000|Outcome|CFNB|Patients with continuous femoral nerve block
11056242|NCT01337115|OG001|Outcome|CFNB+Single Shot SNB|Patients with additional sciatic nerve block
11056243|NCT01337115|EG000|Reported Event|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
11056244|NCT01337115|EG001|Reported Event|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
11056245|NCT01337167|BG000|Baseline|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056246|NCT01337167|BG001|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056247|NCT01337167|BG002|Baseline|Total|Total of all reporting groups
11056248|NCT01337167|FG000|Participant Flow|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056249|NCT01337167|FG001|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056250|NCT01337167|OG000|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056251|NCT01337167|OG001|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056252|NCT01337167|EG000|Reported Event|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056253|NCT01337167|EG001|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056254|NCT01337297|BG000|Baseline|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
11056255|NCT01337297|BG001|Baseline|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
11056256|NCT01337297|BG002|Baseline|Total|Total of all reporting groups
11056257|NCT01337297|FG000|Participant Flow|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
11056258|NCT01337297|FG001|Participant Flow|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
11056259|NCT01337297|OG000|Outcome|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
11056260|NCT01337297|OG001|Outcome|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
11056261|NCT01337297|EG000|Reported Event|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
11056262|NCT01337297|EG001|Reported Event|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
11056263|NCT01337336|BG000|Baseline|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
11056264|NCT01337336|BG001|Baseline|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
11056265|NCT01337336|BG002|Baseline|Total|Total of all reporting groups
11056266|NCT01337336|FG000|Participant Flow|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
11056267|NCT01337336|FG001|Participant Flow|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
11056268|NCT01337336|OG000|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
11056269|NCT01337336|OG001|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
11056270|NCT01337336|EG000|Reported Event|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
11056271|NCT01337336|EG001|Reported Event|AC Cohort|Anticholinergics (AC) include iotropium, and Ipratropium, Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
11056272|NCT01337596|BG000|Baseline|1 mg Single Dose LY2951742|Single dose 1 mg LY2951742 administered subcutaneously.
11056273|NCT01337596|BG001|Baseline|5 mg Single Dose LY2951742|Single dose 5 mg LY2951742 administered subcutaneously.
11056274|NCT01337596|BG002|Baseline|25 mg Single Dose LY2951742|Single dose 25 mg LY2951742 administered subcutaneously.
11056275|NCT01337596|BG003|Baseline|75 mg Single Dose LY2951742|Single dose 75 mg LY2951742 administered subcutaneously.
11056276|NCT01337596|BG004|Baseline|200 mg Single Dose LY2951742|Single dose 200 mg LY2951742 administered subcutaneously.
11056277|NCT01337596|BG005|Baseline|600 mg Single Dose LY2951742|Single dose 600 mg LY2951742 administered subcutaneously.
11056278|NCT01337596|BG006|Baseline|Placebo Single Dose|Single dose matched placebo administered subcutaneously.
11056279|NCT01337596|BG007|Baseline|Placebo Multiple Dose|Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056280|NCT01337596|BG008|Baseline|150 mg Multiple Dose LY2951742|Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056281|NCT01337596|BG009|Baseline|Total|Total of all reporting groups
11056282|NCT01337596|FG000|Participant Flow|1 mg Single Dose LY2951742|Single dose 1 milligram (mg) LY2951742 administered subcutaneously.
11056283|NCT01337596|FG001|Participant Flow|5 mg Single Dose LY2951742|Single dose 5 mg LY2951742 administered subcutaneously.
11226705|NCT02377427|OG001|Outcome|Part A: Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
11056284|NCT01337596|FG002|Participant Flow|25 mg Single Dose LY2951742|Single dose 25 mg LY2951742 administered subcutaneously.
11056285|NCT01337596|FG003|Participant Flow|75 mg Single Dose LY2951742|Single dose 75 mg LY2951742 administered subcutaneously.
11056286|NCT01337596|FG004|Participant Flow|200 mg Single Dose LY2951742|Single dose 200 mg LY2951742 administered subcutaneously.
11056287|NCT01337596|FG005|Participant Flow|600 mg Single Dose LY2951742|Single dose 600 mg LY2951742 administered subcutaneously.
11056288|NCT01337596|FG006|Participant Flow|Placebo Single Dose|Single dose matched placebo administered subcutaneously.
11056289|NCT01337596|FG007|Participant Flow|Placebo Multiple Dose|Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056290|NCT01337596|FG008|Participant Flow|150 mg Multiple Dose LY2951742|Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056291|NCT01337596|OG000|Outcome|1 Milligram (mg) Single Dose LY2951742|Single dose 1 mg LY2951742 administered subcutaneously.
11056292|NCT01337596|OG001|Outcome|5 mg Single Dose LY2951742|Single dose 5 mg LY2951742 administered subcutaneously.
11056293|NCT01337596|OG002|Outcome|25 mg Single Dose LY2951742|Single dose 25 mg LY2951742 administered subcutaneously.
11056294|NCT01337596|OG003|Outcome|75 mg Single Dose LY2951742|Single dose 75 mg LY2951742 administered subcutaneously.
11056295|NCT01337596|OG004|Outcome|200 mg Single Dose LY2951742|Single dose 200 mg LY2951742 administered subcutaneously.
11056296|NCT01337596|OG005|Outcome|600 mg Single Dose LY2951742|Single dose 600 mg LY2951742 administered subcutaneously.
11056297|NCT01337596|OG006|Outcome|Placebo Single Dose|Single dose matched placebo administered subcutaneously.
11056298|NCT01337596|OG007|Outcome|Placebo Multiple Dose|Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056299|NCT01337596|OG008|Outcome|150 mg Multiple Dose LY2951742|Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056300|NCT01337596|OG000|Outcome|1 mg Single Dose LY2951742|Single dose 1 mg LY2951742 administered subcutaneously.
11056301|NCT01337596|OG003|Outcome|75 mg Single Dose LY2951742|Single dose 175mg LY2951742 administered subcutaneously.
11056302|NCT01337596|OG000|Outcome|150 mg Multiple Dose LY2951742|Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056303|NCT01337596|EG000|Reported Event|1 mg Single Dose LY2951742|Single dose 1 mg LY2951742 administered subcutaneously.
11056304|NCT01337596|EG001|Reported Event|5 mg Single Dose LY2951742|Single dose 5 mg LY2951742 administered subcutaneously.
11056305|NCT01337596|EG002|Reported Event|25 mg Single Dose LY2951742|Single dose 25 mg LY2951742 administered subcutaneously.
11056306|NCT01337596|EG003|Reported Event|75 mg Single Dose LY2951742|Single dose 75 mg LY2951742 administered subcutaneously.
11056307|NCT01337596|EG004|Reported Event|200 mg Single Dose LY2951742|Single dose 200 mg LY2951742 administered subcutaneously.
11056308|NCT01337596|EG005|Reported Event|600 mg Single Dose LY2951742|Single dose 600 mg LY2951742 administered subcutaneously.
11056309|NCT01337596|EG006|Reported Event|Placebo Single Dose|Single dose matched placebo administered subcutaneously.
11056310|NCT01337596|EG007|Reported Event|Placebo Multiple Dose|Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056311|NCT01337596|EG008|Reported Event|150 mg Multiple Dose LY2951742|Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
11056312|NCT01337635|BG000|Baseline|Standard Dose Vitamin D|Treatment with cholecalciferol 400 IU oral daily at home for 6 weeks
11056313|NCT01337635|BG001|Baseline|High Dose Vitamin D|Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
11056314|NCT01337635|BG002|Baseline|Total|Total of all reporting groups
11056315|NCT01337635|FG000|Participant Flow|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
11056316|NCT01337635|FG001|Participant Flow|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
11056317|NCT01337635|OG000|Outcome|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
11056318|NCT01337635|OG001|Outcome|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
11056319|NCT01337635|EG000|Reported Event|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
11056320|NCT01337635|EG001|Reported Event|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
11056321|NCT01337674|BG000|Baseline|Panel A Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
11056322|NCT01337674|BG001|Baseline|Panel B Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
11056323|NCT01337674|BG002|Baseline|Total|Total of all reporting groups
11056324|NCT01337674|FG000|Participant Flow|Panel A: MK-4618 + Met → PBO + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
11056325|NCT01337674|FG001|Participant Flow|Panel A: PBO + Met → MK-4618 + Met|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
11056326|NCT01337674|FG002|Participant Flow|Panel B: MK-4618 + Amlo → PBO + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
11056327|NCT01337674|FG003|Participant Flow|Panel B: PBO + Amlo → MK-4618 + Amlo|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
11056328|NCT01337674|OG000|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
11056329|NCT01337674|OG001|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
11056330|NCT01337674|OG002|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
11056331|NCT01337674|OG003|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
11056332|NCT01337674|OG000|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
11056333|NCT01337674|OG001|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
11056334|NCT01337674|OG001|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
11056335|NCT01337674|EG000|Reported Event|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
11056336|NCT01337674|EG001|Reported Event|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
11056337|NCT01337674|EG002|Reported Event|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
11056338|NCT01337674|EG003|Reported Event|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
11056339|NCT01337687|BG000|Baseline|Oxytocin|Intranasal Oxytocin: Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.
11056340|NCT01337687|BG001|Baseline|Placebo|Placebo: Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.
11056341|NCT01337687|BG002|Baseline|Total|Total of all reporting groups
11056342|NCT01337687|FG000|Participant Flow|Oxytocin|Intranasal Oxytocin: Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.
11056343|NCT01337687|FG001|Participant Flow|Placebo|Placebo: Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.
11056344|NCT01337687|OG000|Outcome|Oxytocin|Intranasal Oxytocin: Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.
11056345|NCT01337687|OG001|Outcome|Placebo|Placebo: Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.
11056346|NCT01337687|EG000|Reported Event|Oxytocin|Intranasal Oxytocin: Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.
11056347|NCT01337687|EG001|Reported Event|Placebo|Placebo: Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.
11056348|NCT01337700|BG000|Baseline|Milnacipran|Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.
11056349|NCT01337700|BG001|Baseline|Placebo|Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
11056350|NCT01337700|BG002|Baseline|Total|Total of all reporting groups
11056351|NCT01337700|FG000|Participant Flow|Milnacipran|Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.
11056352|NCT01337700|FG001|Participant Flow|Placebo|Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
11056353|NCT01337700|OG000|Outcome|Milnacipran|Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 200mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.
11056354|NCT01337700|OG001|Outcome|Placebo|Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
11056355|NCT01337700|EG000|Reported Event|Milnacipran|Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.
11056356|NCT01337700|EG001|Reported Event|Placebo|Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
11056357|NCT01337739|BG000|Baseline|Placebo Comparator|Continuous infusion of placebo during operative procedure
11056358|NCT01337739|BG001|Baseline|Active Comparator|Administration of Dexmedetomidine
11056359|NCT01337739|BG002|Baseline|Total|Total of all reporting groups
11056360|NCT01337739|FG000|Participant Flow|Placebo Comparator|Continuous infusion of placebo during operative procedure
11056361|NCT01337739|FG001|Participant Flow|Active Comparator|Administration of Dexmedetomidine
11056362|NCT01337739|OG000|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
11056363|NCT01337739|OG001|Outcome|Active Comparator|Administration of Dexmedetomidine
11056364|NCT01337739|EG000|Reported Event|Placebo Comparator|Continuous infusion of placebo during operative procedure
11056365|NCT01337739|EG001|Reported Event|Active Comparator|Administration of Dexmedetomidine
11056366|NCT01337960|BG000|Baseline|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
11056367|NCT01337960|BG001|Baseline|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
11056368|NCT01337960|BG002|Baseline|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
11056369|NCT01337960|BG003|Baseline|Total|Total of all reporting groups
11056370|NCT01337960|FG000|Participant Flow|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
11056371|NCT01337960|FG001|Participant Flow|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
11056372|NCT01337960|FG002|Participant Flow|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
11056373|NCT01337960|OG000|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
11056374|NCT01337960|OG001|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
11056375|NCT01337960|OG002|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
11056376|NCT01337960|EG000|Reported Event|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
11056377|NCT01337960|EG001|Reported Event|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
11056378|NCT01337960|EG002|Reported Event|Trll Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
11056379|NCT01337973|BG000|Baseline|Arm 1: MI-CBT|"MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)~MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches"
11056380|NCT01337973|BG001|Baseline|Arm 2: MI-CBT+CC|"MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)~MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention"
11056381|NCT01337973|BG002|Baseline|Arm 3: E-TAU|"E-TAU (enhanced treatment as usual - includes brief session and provision of resources)~E-TAU: Enhanced Treatment as Usual"
11056382|NCT01337973|BG003|Baseline|Total|Total of all reporting groups
11056383|NCT01337973|FG000|Participant Flow|Arm 1: MI-CBT|"MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)~MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches"
11056384|NCT01337973|FG001|Participant Flow|Arm 2: MI-CBT+CC|"MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)~MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention"
11056385|NCT01337973|FG002|Participant Flow|Arm 3: E-TAU|"E-TAU (enhanced treatment as usual - includes brief session and provision of resources)~E-TAU: Enhanced Treatment as Usual"
11056386|NCT01337973|OG000|Outcome|Arm 1: MI-CBT|"MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)~MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches"
11056387|NCT01337973|OG001|Outcome|Arm 2: MI-CBT+CC|"MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)~MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention"
11056388|NCT01337973|OG002|Outcome|Arm 3: E-TAU|"E-TAU (enhanced treatment as usual - includes brief session and provision of resources)~E-TAU: Enhanced Treatment as Usual"
11226706|NCT02377427|OG000|Outcome|Part B: Mepolizumab 40 mg SC|Participants with bodyweight < 40 kg received 0.4 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
11056389|NCT01337973|EG000|Reported Event|Arm 1: MI-CBT|"MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)~MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches"
11056390|NCT01337973|EG001|Reported Event|Arm 2: MI-CBT+CC|"MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)~MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention"
11056391|NCT01337973|EG002|Reported Event|Arm 3: E-TAU|"E-TAU (enhanced treatment as usual - includes brief session and provision of resources)~E-TAU: Enhanced Treatment as Usual"
11056392|NCT01337986|BG000|Baseline|Group B: Dalfampridine/Placebo|Dalfampridine/Placebo: Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
11056393|NCT01337986|BG001|Baseline|Group A: Placebo/Dalfampridine|Placebo/Dalfampridine: Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.
11056394|NCT01337986|BG002|Baseline|Total|Total of all reporting groups
11056395|NCT01337986|FG000|Participant Flow|Group B: Dalfampridine/Placebo|Dalfampridine/Placebo: Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
11056396|NCT01337986|FG001|Participant Flow|Group A: Placebo/Dalfampridine|Placebo/Dalfampridine: Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.
11226707|NCT02377427|OG001|Outcome|Part B: Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
11056397|NCT01337986|OG000|Outcome|Group B: Dalfampridine|Dalfampridine/Placebo: Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
11056398|NCT01337986|OG001|Outcome|Group B: Placebo|Dalfampridine/Placebo: Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
11056399|NCT01337986|OG002|Outcome|Group A: Placebo|Placebo/Dalfampridine: Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.
11056400|NCT01337986|OG003|Outcome|Group A: Dalfampridine|Placebo/Dalfampridine: Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.
11056401|NCT01337986|OG000|Outcome|Dalfampridine|Patient Assessments while on Dalfampridine
11056402|NCT01337986|OG001|Outcome|Placebo|Patient Assessments while on Dalfampridine
11056403|NCT01337986|OG000|Outcome|Dalfampridine|Improvement while on Dalfampridine (not placebo)
11056404|NCT01337986|OG001|Outcome|Placebo|Improvement while on Placebo (not dalfampridine)
11056405|NCT01337986|OG002|Outcome|Both|Improvement when taking Dalfampridine or Placebo (improvement with any treatment)
11056406|NCT01337986|OG003|Outcome|None|No Improvement on Dalfampridine/Placebo.
11056407|NCT01337986|OG000|Outcome|Dalfampridine|Improvement while on Dalfampridine
11056408|NCT01337986|OG001|Outcome|Placebo|Improvement while on Placebo
11056409|NCT01337986|OG002|Outcome|Both|Improvement on Dalfampridine and Placebo
11056410|NCT01337986|OG003|Outcome|Neither|No Improvement on Dalfampridine or Placebo
11056411|NCT01337986|OG000|Outcome|Dalfampridine Then Placebo|Weeks 1-3 Dalfampridine 10 mg Twice Daily, Weeks 6-8 Placebo Twice Daily
11056412|NCT01337986|OG001|Outcome|Placebo Then Dalfampridine|Weeks 1-3 Placebo Twice Daily, Weeks 6-8 Dalfampridine 10 mg Twice Daily
11056413|NCT01337986|OG000|Outcome|Dalfampridine|Study participants on dalfampridine
11056414|NCT01337986|OG001|Outcome|Placebo|Study participants on placebo
11056415|NCT01337986|EG000|Reported Event|Dalfampridine|Participants assigned to received dalfampridine.
11056416|NCT01337986|EG001|Reported Event|Placebo|Participants assigned to received placebo.
11056417|NCT01338012|BG000|Baseline|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
11056418|NCT01338012|FG000|Participant Flow|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
11056419|NCT01338012|OG000|Outcome|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
11056420|NCT01338012|EG000|Reported Event|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
11066779|NCT01393964|EG001|Reported Event|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
11066780|NCT01393964|EG002|Reported Event|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
11066781|NCT01393990|BG000|Baseline|Part A: 10 mg LY2228820 Capsules|10 milligrams (mg) LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066782|NCT01393990|BG001|Baseline|Part A: 20 mg LY2228820 Capsules|20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066783|NCT01393990|BG002|Baseline|Part A: 40 mg LY2228820 Capsules|40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066784|NCT01393990|BG003|Baseline|Part A: 65 mg LY2228820 Capsules|65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066785|NCT01393990|BG004|Baseline|Part A: 90 mg LY2228820 Capsules|90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066786|NCT01393990|BG005|Baseline|Part A: 120 mg LY2228820 Capsules|120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066787|NCT01393990|BG006|Baseline|Part A: 160 mg LY2228820 Capsules|160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066788|NCT01393990|BG007|Baseline|Part A: 200 mg LY2228820 Capsules|200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066789|NCT01393990|BG008|Baseline|Part A: 160 mg Bridge LY2228820|In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
11066790|NCT01393990|BG009|Baseline|Part A: 160 mg LY2228820 Tablets|160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066791|NCT01393990|BG010|Baseline|Part A: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066792|NCT01393990|BG011|Baseline|Part A: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11056421|NCT01338025|BG000|Baseline|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
11056422|NCT01338025|BG001|Baseline|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
11056423|NCT01338025|BG002|Baseline|Total|Total of all reporting groups
11056424|NCT01338025|FG000|Participant Flow|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects were randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider."
11056425|NCT01338025|FG001|Participant Flow|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)"
11056426|NCT01338025|OG000|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
11056427|NCT01338025|OG001|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
11056428|NCT01338025|EG000|Reported Event|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
11056429|NCT01338025|EG001|Reported Event|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
11056430|NCT01338298|BG000|Baseline|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
11056431|NCT01338298|BG001|Baseline|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
11056432|NCT01338298|BG002|Baseline|Total|Total of all reporting groups
11056433|NCT01338298|FG000|Participant Flow|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
11056434|NCT01338298|FG001|Participant Flow|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
11056435|NCT01338298|OG000|Outcome|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
11056436|NCT01338298|OG001|Outcome|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
11056437|NCT01338298|EG000|Reported Event|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
11056438|NCT01338298|EG001|Reported Event|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
11056439|NCT01338415|BG000|Baseline|Bosentan 2mg/kg b.i.d.|Patients received 2 milligrams per kilogram (mg/kg) bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study.
11056440|NCT01338415|BG001|Baseline|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study.
11056441|NCT01338415|BG002|Baseline|Total|Total of all reporting groups
11056442|NCT01338415|FG000|Participant Flow|Bosentan 2mg/kg b.i.d.|Patients received 2 milligrams per kilogram (mg/kg) bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study.
11056443|NCT01338415|FG001|Participant Flow|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study.
11056444|NCT01338415|FG002|Participant Flow|Bosentan 2mg/kg b.i.d or t.i.d. During EUTP|Participants who entered the exceptional use treatment period (EUTP), continued receiving 2 mg/kg bosentan b.i.d or t.i.d up to Amendment B. After implementation of Amendment B, all participants received 2 mg/kg bosentan b.i.d.
11056445|NCT01338415|OG000|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 milligrams per kilogram (mg/kg) bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study.
11056446|NCT01338415|OG001|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study.
11056447|NCT01338415|OG000|Outcome|Bosentan 2mg/kg b.i.d or t.i.d. During EUTP|Participants who entered the exceptional use treatment period (EUTP), continued receiving 2 mg/kg bosentan b.i.d or t.i.d up to Amendment B. After implementation of Amendment B, all participants received 2 mg/kg bosentan b.i.d.
11056448|NCT01338415|EG000|Reported Event|Bosentan 2mg/kg b.i.d.|2 mg/kg bosentan was administered twice daily for a cumulative mean (± SD) duration of 64.1 ± 3.38 weeks (FUTURE 3 core + extension studies)
11056449|NCT01338415|EG001|Reported Event|Bosentan 2mg/kg t.i.d|2 mg/kg bosentan was administered 3 times a day for a cumulative mean (± SD) duration of 60.4 ± 4.20 weeks (FUTURE 3 core + extension studies)
11056450|NCT01338415|EG002|Reported Event|Bosentan 2mg/kg b.i.d or t.i.d. During EUTP|Participants who entered the exceptional use treatment period (EUTP), continued receiving 2 mg/kg bosentan b.i.d or t.i.d up to Amendment B. After implementation of Amendment B, all participants received 2 mg/kg bosentan b.i.d. Due to change in study conduct, participants treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17-03-2015 for Belarus and Ukraine, 1-04-2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the data were combined for Bosentan b.i.d. and t.i.d.
11056451|NCT01338493|BG000|Baseline|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
11056452|NCT01338493|FG000|Participant Flow|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
11056453|NCT01338493|OG000|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
11056454|NCT01338493|EG000|Reported Event|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
11056455|NCT01338506|BG000|Baseline|Treatment as Usual|"Relapse Prevention (RP) for substance use disorders.~Included 12 sessions of RP matched for time."
11056456|NCT01338506|BG001|Baseline|COPE Therapy|"Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056457|NCT01338506|BG002|Baseline|Total|Total of all reporting groups
11056458|NCT01338506|FG000|Participant Flow|COPE Therapy|"Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056459|NCT01338506|FG001|Participant Flow|Treatment as Usual|"Current standard treatment available through the Department of Veteran's Affairs.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056460|NCT01338506|OG000|Outcome|COPE Therapy|"Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056461|NCT01338506|OG001|Outcome|Treatment as Usual|"CBT for substance use disorder.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056462|NCT01338506|OG000|Outcome|COPE Therapy|"Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056463|NCT01338506|OG001|Outcome|Treatment as Usual|"Current standard treatment available through the Department of Veteran's Affairs.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056464|NCT01338506|OG000|Outcome|Treatment as Usual|"Relapse Prevention (RP) for substance use disorders.~Included 12 sessions of RP matched for time."
11056465|NCT01338506|OG001|Outcome|COPE Therapy|"Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056466|NCT01338506|EG000|Reported Event|COPE Therapy|"Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056467|NCT01338506|EG001|Reported Event|Treatment as Usual|"Current standard treatment available through the Department of Veteran's Affairs.~Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."
11056468|NCT01338610|BG000|Baseline|Run-In Only|ESBA105 vehicle
11056469|NCT01338610|BG001|Baseline|ESBA105|ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
11056470|NCT01338610|BG002|Baseline|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
11056471|NCT01338610|BG003|Baseline|Total|Total of all reporting groups
11056472|NCT01338610|FG000|Participant Flow|Run-In Only|ESBA105 vehicle
11056473|NCT01338610|FG001|Participant Flow|ESBA105|ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
11056474|NCT01338610|FG002|Participant Flow|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
11056475|NCT01338610|OG000|Outcome|ESBA105|ESBA105 ophthalmic solution
11056476|NCT01338610|OG001|Outcome|Vehicle|ESBA105 vehicle
11056477|NCT01338610|EG000|Reported Event|Run-In|ESBA105 vehicle, all participants
11056478|NCT01338610|EG001|Reported Event|ESBA105|ESBA105 ophthalmic solution
11056479|NCT01338610|EG002|Reported Event|Vehicle|ESBA105 vehicle
11056480|NCT01338649|BG000|Baseline|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
11056481|NCT01338649|BG001|Baseline|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
11056482|NCT01338649|BG002|Baseline|Total|Total of all reporting groups
11056483|NCT01338649|FG000|Participant Flow|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
11056484|NCT01338649|FG001|Participant Flow|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
11056485|NCT01338649|OG000|Outcome|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
11056486|NCT01338649|OG001|Outcome|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
11056487|NCT01338649|EG000|Reported Event|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
11056488|NCT01338649|EG001|Reported Event|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
11056489|NCT01338792|BG000|Baseline|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11056490|NCT01338792|FG000|Participant Flow|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11056491|NCT01338792|OG000|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11056492|NCT01338792|EG000|Reported Event|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11056493|NCT01338818|BG000|Baseline|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
11056494|NCT01338818|FG000|Participant Flow|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
11056495|NCT01338818|OG000|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
11056496|NCT01338818|EG000|Reported Event|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
11056497|NCT01338857|BG000|Baseline|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
11056498|NCT01338857|FG000|Participant Flow|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
11056499|NCT01338857|OG000|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
11056500|NCT01338857|EG000|Reported Event|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
11056501|NCT01338870|BG000|Baseline|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056502|NCT01338870|BG001|Baseline|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056503|NCT01338870|BG002|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056504|NCT01338870|BG003|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056505|NCT01338870|BG004|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056506|NCT01338870|BG005|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056507|NCT01338870|BG006|Baseline|Total|Total of all reporting groups
11056508|NCT01338870|FG000|Participant Flow|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056509|NCT01338870|FG001|Participant Flow|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056510|NCT01338870|FG002|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056511|NCT01338870|FG003|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056512|NCT01338870|FG004|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056513|NCT01338870|FG005|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056514|NCT01338870|OG000|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056515|NCT01338870|OG001|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056516|NCT01338870|OG002|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056517|NCT01338870|OG003|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056518|NCT01338870|OG004|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056519|NCT01338870|OG005|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056520|NCT01338870|EG000|Reported Event|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056521|NCT01338870|EG001|Reported Event|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056522|NCT01338870|EG002|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056523|NCT01338870|EG003|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056524|NCT01338870|EG004|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056525|NCT01338870|EG005|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
11056526|NCT01338987|BG000|Baseline|Males That Did Not Receive Leuprolide for 1st Transplant|Males undergoing first transplant who did not receive leuprolide.
11056527|NCT01338987|BG001|Baseline|Males Randomized to Receive Leuprolide for 1st Transplant|Males undergoing first transplant who were randomized to receive leuprolide.
11056528|NCT01338987|BG002|Baseline|Females That Received Leuprolide for 1st Transplant|Females undergoing first transplant who all received leuprolide.
11056529|NCT01338987|BG003|Baseline|Matched Related Donors for Transplant|Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
11056530|NCT01338987|BG004|Baseline|Recipients of 2nd Transplant|Patients receiving second allogeneic Bone Marrow Transplant on this study.
11056531|NCT01338987|BG005|Baseline|Total|Total of all reporting groups
11056532|NCT01338987|FG000|Participant Flow|Males That Did Not Receive Leuprolide for 1st Transplant|Males undergoing first transplant who did not receive leuprolide.
11056533|NCT01338987|FG001|Participant Flow|Males Randomized to Receive Leuprolide for 1st Transplant|Males undergoing first transplant who were randomized to receive leuprolide.
11056534|NCT01338987|FG002|Participant Flow|Females That Received Leuprolide for 1st Transplant|Females undergoing first transplant who all received leuprolide.
11056535|NCT01338987|FG003|Participant Flow|Matched Related Donors for Transplant|Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
11056536|NCT01338987|FG004|Participant Flow|Recipients of 2nd Transplant|Patients receiving second allogeneic bone marrow transplant on this study.
11056537|NCT01338987|OG000|Outcome|Transplant Recipient|Patients receiving first allogeneic bone marrow transplant on this study.
11056538|NCT01338987|OG000|Outcome|Transplant Recipient - 2nd Bone Marrow Transplant|Patients receiving second allogeneic bone marrow transplant on this study.
11056539|NCT01338987|OG000|Outcome|Males That Did Not Receive Leuprolide for 1st Transplant|Males undergoing first transplant who did not receive leuprolide.
11056540|NCT01338987|OG001|Outcome|Males Randomized to Receive Leuprolide for 1st Transplant|Males undergoing first transplant who were randomized to receive leuprolide.
11056541|NCT01338987|OG002|Outcome|Females That Received Leuprolide for 1st Transplant|Females undergoing first transplant who all received leuprolide.
11056542|NCT01338987|OG003|Outcome|Matched Related Donors for Transplant|Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic Bone Marrow Transplant on this study.
11056543|NCT01338987|OG004|Outcome|Recipients of 2nd Transplant|Patients receiving second allogeneic Bone Marrow Transplant on this study.
11056544|NCT01338987|EG000|Reported Event|Males That Did Not Receive Leuprolide for 1st Transplant|Males undergoing first transplant who did not receive leuprolide.
11056545|NCT01338987|EG001|Reported Event|Males Randomized to Receive Leuprolide for 1st Transplant|Males undergoing first transplant who were randomized to receive leuprolide.
11056546|NCT01338987|EG002|Reported Event|Females That Received Leuprolide for 1st Transplant|Females undergoing first transplant who all received leuprolide.
11056547|NCT01338987|EG003|Reported Event|Matched Related Donors for Transplant|Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
11056548|NCT01338987|EG004|Reported Event|Recipients of 2nd Transplant|Patients receiving second allogeneic bone marrow transplant on this study.
11056549|NCT01339000|BG000|Baseline|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056550|NCT01339000|BG001|Baseline|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056551|NCT01339000|BG002|Baseline|Total|Total of all reporting groups
11066793|NCT01393990|BG012|Baseline|Part A: 420 mg LY2228820 Tablets|420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066794|NCT01393990|BG013|Baseline|Part A: 560 mg LY2228820 Tablets|560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11056552|NCT01339000|FG000|Participant Flow|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056553|NCT01339000|FG001|Participant Flow|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056554|NCT01339000|OG000|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056555|NCT01339000|OG001|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056556|NCT01339000|OG000|Outcome|Arm A -Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056557|NCT01339000|OG000|Outcome|Arm A - Sequence 1 Immunizationa|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056558|NCT01339000|OG001|Outcome|Arm B - Sequence Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056559|NCT01339000|EG000|Reported Event|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11066795|NCT01393990|BG014|Baseline|Part B: 420 mg LY2228820 Tablets|420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
11066796|NCT01393990|BG015|Baseline|Part C: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
11056560|NCT01339000|EG001|Reported Event|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
11056561|NCT01339013|BG000|Baseline|All Study Participants|Heat and Moisture Exchanger, then AnaConDa, finally Heat and Moisture Exchanger
11056562|NCT01339013|FG000|Participant Flow|AnaConDa Replaces the Heat and Moisture Exchanger|The conventional Heat and Moisture Exchanger is replaced by the AnaConDa which in turn is replaced by the conventional Heat and Moisture Exchanger.
11056563|NCT01339013|OG000|Outcome|AnaConDa|Anesthetic Conserving Device (AnaConDa) has a charcoal filter.
11056564|NCT01339013|EG000|Reported Event|AnaConDa|Anesthetic Conserving Device (AnaConDa or ACD) has a charcoal filter.
11056565|NCT01339052|BG000|Baseline|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
11056566|NCT01339052|BG001|Baseline|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
11056567|NCT01339052|BG002|Baseline|Total|Total of all reporting groups
11056568|NCT01339052|FG000|Participant Flow|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
11056569|NCT01339052|FG001|Participant Flow|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
11056570|NCT01339052|OG000|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
11056571|NCT01339052|OG000|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
11056572|NCT01339052|OG000|Outcome|Cohort I: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
11056573|NCT01339052|OG000|Outcome|Cohorts 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
11056574|NCT01339052|OG001|Outcome|Cohorts 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
11056575|NCT01339052|EG000|Reported Event|Cohorts 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
11056576|NCT01339052|EG001|Reported Event|Cohorts 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
11056577|NCT01339091|BG000|Baseline|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
11056578|NCT01339091|BG001|Baseline|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
11056579|NCT01339091|BG002|Baseline|Total|Total of all reporting groups
11056580|NCT01339091|FG000|Participant Flow|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
11056581|NCT01339091|FG001|Participant Flow|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
11056582|NCT01339091|OG000|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
11056583|NCT01339091|OG001|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
11056584|NCT01339091|EG000|Reported Event|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
11056585|NCT01339091|EG001|Reported Event|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
11056586|NCT01339247|BG000|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in Period 1 and test product in Period 2
11056587|NCT01339247|FG000|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
11056588|NCT01339247|FG001|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1; followed by test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
11056589|NCT01339247|OG000|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
11056590|NCT01339247|OG001|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
11056591|NCT01339247|EG000|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
11056592|NCT01339247|EG001|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
11056593|NCT01339260|BG000|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
11056594|NCT01339260|BG001|Baseline|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
11056595|NCT01339260|BG002|Baseline|Total|Total of all reporting groups
11056596|NCT01339260|FG000|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
11056597|NCT01339260|FG001|Participant Flow|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
11056598|NCT01339260|OG000|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
11056599|NCT01339260|OG001|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
11056600|NCT01339260|EG000|Reported Event|Netupitant and Palonosetron+Dexamethasone-cycle 1|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
11056601|NCT01339260|EG001|Reported Event|Palonosetron+Dexamethasone-cycle 1|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
11056602|NCT01339260|EG002|Reported Event|Netupitant and Palonosetron+Dexamethasone-multicycle Extension|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
11056603|NCT01339260|EG003|Reported Event|Palonosetron+Dexamethasone-multicycle Extension|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
11056604|NCT01339273|BG000|Baseline|TAP Block|"Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster~Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster"
11056605|NCT01339273|BG001|Baseline|Local Anaesthetic Infiltration|"Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.~Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made."
11056606|NCT01339273|BG002|Baseline|Total|Total of all reporting groups
11056607|NCT01339273|FG000|Participant Flow|TAP Block|"Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster~Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster"
11056608|NCT01339273|FG001|Participant Flow|Local Anaesthetic Infiltration|"Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.~Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made."
11056609|NCT01339273|OG000|Outcome|TAP Block|"Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster~Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster"
11056610|NCT01339273|OG001|Outcome|Local Anaesthetic Infiltration|"Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.~Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made."
11056611|NCT01339273|EG000|Reported Event|TAP Block|"Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster~Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster"
11056612|NCT01339273|EG001|Reported Event|Local Anaesthetic Infiltration|"Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.~Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made."
11056613|NCT01339299|BG000|Baseline|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
11056614|NCT01339299|BG001|Baseline|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
11056615|NCT01339299|BG002|Baseline|Total|Total of all reporting groups
11056616|NCT01339299|FG000|Participant Flow|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
11056617|NCT01339299|FG001|Participant Flow|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
11056618|NCT01339299|OG000|Outcome|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
11056619|NCT01339299|OG001|Outcome|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
11056620|NCT01339299|EG000|Reported Event|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
11056621|NCT01339299|EG001|Reported Event|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
11056622|NCT01339390|BG000|Baseline|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
11056623|NCT01339390|BG001|Baseline|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
11056624|NCT01339390|BG002|Baseline|Total|Total of all reporting groups
11056625|NCT01339390|FG000|Participant Flow|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
11066797|NCT01393990|BG016|Baseline|Part D: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11056626|NCT01339390|FG001|Participant Flow|Arm 2: MOVE!|"As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
11056627|NCT01339390|OG000|Outcome|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
11056628|NCT01339390|OG001|Outcome|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
11056629|NCT01339390|EG000|Reported Event|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
11056630|NCT01339390|EG001|Reported Event|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
11056631|NCT01339403|BG000|Baseline|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
11056632|NCT01339403|BG001|Baseline|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
11056633|NCT01339403|BG002|Baseline|Total|Total of all reporting groups
11056634|NCT01339403|FG000|Participant Flow|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
11056635|NCT01339403|FG001|Participant Flow|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
11056636|NCT01339403|OG000|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
11056637|NCT01339403|OG001|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
11056638|NCT01339403|EG000|Reported Event|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
11056639|NCT01339403|EG001|Reported Event|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
11056640|NCT01339416|BG000|Baseline|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
11056641|NCT01339416|FG000|Participant Flow|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
11056642|NCT01339416|OG000|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
11056643|NCT01339416|EG000|Reported Event|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
11056644|NCT01339429|BG000|Baseline|Simplified Negative Pressure Wound Therapy|"The simplified Negative Pressure device will be placed on subjects selected from the hospital wards and meeting the eligibility criteria.~simplified Negative Pressure device: A non-powered negative pressure device utilizing a bellows which is compressed every eight hours."
11056645|NCT01339429|FG000|Participant Flow|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from hospital wards and meeting the eligibility criteria regarding wound size and condition. Inclusion criteria included age 14 years or older, adequate adjacent intact skin and wound location for application of the sNPWT dressing, adequate pain control, and anticipated clinically stability and hospitalization for the duration of the study. Exclusion criteria were exposed blood vessels, evidence of ischemia, necrotic tissue requiring further debridement, infection, osteomyelitis, and malignancy in the wound.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing via a drainage tube."
11056646|NCT01339429|OG000|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
11056647|NCT01339429|EG000|Reported Event|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from the hospital wards and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
11056648|NCT01339559|BG000|Baseline|Brivaracetam|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
11056649|NCT01339559|FG000|Participant Flow|Brivaracetam|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
11056650|NCT01339559|OG000|Outcome|Brivaracetam (SS)|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
11056651|NCT01339559|OG000|Outcome|Brivaracetam (POS Efficacy)|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Partial Onset Seizure Efficacy Set (POS Efficacy).
11056652|NCT01339559|EG000|Reported Event|Brivaracetam (SS)|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
11056653|NCT01339832|BG000|Baseline|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
11056654|NCT01339832|FG000|Participant Flow|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
11056655|NCT01339832|OG000|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
11056656|NCT01339832|EG000|Reported Event|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
11056657|NCT01339858|BG000|Baseline|N-Acetyl Cysteine|NAC and matched placebo will be supplied in unmarked capsules. Each NAC capsule will contain 600 mg of NAC. Dosing will begin at 600 mg/d and titrated up over 5 weeks until a maximum dose of 3600 mg/d is reached. Dose adjustments downward to 1920 mg/d will be permitted if tolerability issues are encountered at the maximum dose.
11056658|NCT01339858|BG001|Baseline|Sugar Pill|"matched placebo~sugar pill: matched placebo will be supplied in unmarked capsules. Dosing regimen will be the same as in the N-Acetyl Cysteine arm."
11056659|NCT01339858|BG002|Baseline|Total|Total of all reporting groups
11056660|NCT01339858|FG000|Participant Flow|N-Acetyl Cysteine|NAC and matched placebo will be supplied in unmarked capsules. Each NAC capsule will contain 600 mg of NAC. Dosing will begin at 600 mg/d and titrated up over 5 weeks until a maximum dose of 3600 mg/d is reached. Dose adjustments downward to 1920 mg/d will be permitted if tolerability issues are encountered at the maximum dose.
11056661|NCT01339858|FG001|Participant Flow|Sugar Pill|"matched placebo~sugar pill: matched placebo will be supplied in unmarked capsules. Dosing regimen will be the same as in the N-Acetyl Cysteine arm."
11056662|NCT01339858|OG000|Outcome|N-Acetyl Cysteine|NAC and matched placebo will be supplied in unmarked capsules. Each NAC capsule will contain 600 mg of NAC. Dosing will begin at 600 mg/d and titrated up over 5 weeks until a maximum dose of 3600 mg/d is reached. Dose adjustments downward to 1920 mg/d will be permitted if tolerability issues are encountered at the maximum dose.
11056663|NCT01339858|OG001|Outcome|Sugar Pill|"matched placebo~sugar pill: matched placebo will be supplied in unmarked capsules. Dosing regimen will be the same as in the N-Acetyl Cysteine arm."
11056664|NCT01339858|OG000|Outcome|NAC Treated Early Psychosis Patients|Longitudinal concentrations of glutamine/glutamate (Glx) levels across three scans for NAC treated patients
11056665|NCT01339858|OG001|Outcome|Placebo Group|
11056666|NCT01339858|EG000|Reported Event|N-Acetyl Cysteine|NAC and matched placebo will be supplied in unmarked capsules. Each NAC capsule will contain 600 mg of NAC. Dosing will begin at 600 mg/d and titrated up over 5 weeks until a maximum dose of 3600 mg/d is reached. Dose adjustments downward to 1920 mg/d will be permitted if tolerability issues are encountered at the maximum dose.
11056667|NCT01339858|EG001|Reported Event|Sugar Pill|"matched placebo~sugar pill: matched placebo will be supplied in unmarked capsules. Dosing regimen will be the same as in the N-Acetyl Cysteine arm."
11056668|NCT01339897|BG000|Baseline|Cohort 1|N6022 - Active 5 mg
11056669|NCT01339897|BG001|Baseline|Cohort 2|N6022 - Active 10 mg
11056670|NCT01339897|BG002|Baseline|Cohort 3|N6022 - Active 20 mg
11056671|NCT01339897|BG003|Baseline|Placebo|Non-Active
11056672|NCT01339897|BG004|Baseline|Total|Total of all reporting groups
11056673|NCT01339897|FG000|Participant Flow|5 mg/N6022|Active Group- 5 mg by IV administration (5 mg/minute)
11056674|NCT01339897|FG001|Participant Flow|Placebo|Non-Active
11056675|NCT01339897|FG002|Participant Flow|10 mg/N6022|Active Group- 10 mg by IV administration (5 mg/minute)
11056676|NCT01339897|FG003|Participant Flow|20 mg/N6022|Active Group- 20 mg by IV administration (5 mg/minute)
11056677|NCT01339897|OG000|Outcome|Cohort 1|N6022 - Active 5 mg
11056678|NCT01339897|OG001|Outcome|Cohort 2|N6022 Active - 10 mg
11056679|NCT01339897|OG002|Outcome|Cohort 3|N6022 - Active 20 mg
11056680|NCT01339897|OG003|Outcome|Placebo|Non-Active
11056681|NCT01339897|OG000|Outcome|Cohort 1|N6022 Active - 5 mg
11056682|NCT01339897|OG002|Outcome|Cohort 3|N6022 Active - 20 mg
11056683|NCT01339897|EG000|Reported Event|Cohort 1|N6022 - Active 5 mg
11056684|NCT01339897|EG001|Reported Event|Cohort 2|N6022 Active - 10 mg
11056685|NCT01339897|EG002|Reported Event|Cohort 3|N6022 - Active 20 mg
11056686|NCT01339897|EG003|Reported Event|Placebo|Non-Active
11056687|NCT01339910|BG000|Baseline|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
11056688|NCT01339910|BG001|Baseline|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
11056689|NCT01339910|BG002|Baseline|Total|Total of all reporting groups
11056690|NCT01339910|FG000|Participant Flow|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
11056691|NCT01339910|FG001|Participant Flow|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
11056692|NCT01339910|OG000|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
11056693|NCT01339910|OG001|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
11056694|NCT01339910|EG000|Reported Event|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
11056695|NCT01339910|EG001|Reported Event|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
11056696|NCT01339923|BG000|Baseline|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
11056697|NCT01339923|BG001|Baseline|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
11056698|NCT01339923|BG002|Baseline|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
11056699|NCT01339923|BG003|Baseline|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
11056700|NCT01339923|BG004|Baseline|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
11341970|NCT03694210|BG000|Baseline|EndoRotor Therapy|"Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.~EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis."
11056701|NCT01339923|BG005|Baseline|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
11056702|NCT01339923|BG006|Baseline|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
11056703|NCT01339923|BG007|Baseline|TOTAL|Total of all reporting groups
11056704|NCT01339923|FG000|Participant Flow|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
11056705|NCT01339923|FG001|Participant Flow|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
11056706|NCT01339923|FG002|Participant Flow|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
11056707|NCT01339923|FG003|Participant Flow|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
11056708|NCT01339923|FG004|Participant Flow|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
11056709|NCT01339923|FG005|Participant Flow|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
11056710|NCT01339923|FG006|Participant Flow|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
11056711|NCT01339923|OG000|Outcome|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
11056712|NCT01339923|OG001|Outcome|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
11056713|NCT01339923|OG000|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months of age) plus booster (11 months of age)"
11056714|NCT01339923|OG000|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
11056715|NCT01339923|OG000|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
11056716|NCT01339923|OG001|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
11056717|NCT01339923|OG002|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
11056718|NCT01339923|OG003|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
11056719|NCT01339923|OG000|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
11056720|NCT01339923|OG001|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
11056721|NCT01339923|OG002|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
11056722|NCT01339923|OG001|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
11056723|NCT01339923|OG001|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
11056724|NCT01339923|OG000|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
11066798|NCT01393990|BG017|Baseline|Part D: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11056725|NCT01339923|OG001|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
11056726|NCT01339923|OG000|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5 12 rMenB + OMV vaccine"
11056727|NCT01339923|OG001|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 ad 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
11056728|NCT01339923|OG000|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
11056729|NCT01339923|OG001|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
11056730|NCT01339923|EG000|Reported Event|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
11056731|NCT01339923|EG001|Reported Event|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
11056732|NCT01339923|EG002|Reported Event|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
11056733|NCT01339923|EG003|Reported Event|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
11056734|NCT01339923|EG004|Reported Event|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
11056735|NCT01339923|EG005|Reported Event|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
11056736|NCT01339923|EG006|Reported Event|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
11056737|NCT01339923|EG007|Reported Event|TOTAL|All subjects in the safety population.
11056738|NCT01339936|BG000|Baseline|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
11056739|NCT01339936|FG000|Participant Flow|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
11056740|NCT01339936|OG000|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
11056741|NCT01339936|EG000|Reported Event|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
11056742|NCT01340014|BG000|Baseline|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
11056743|NCT01340014|BG001|Baseline|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
11056744|NCT01340014|BG002|Baseline|Total|Total of all reporting groups
11056745|NCT01340014|FG000|Participant Flow|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
11056746|NCT01340014|FG001|Participant Flow|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
11056747|NCT01340014|OG000|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
11056748|NCT01340014|OG001|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
11056749|NCT01340014|EG000|Reported Event|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
11056750|NCT01340014|EG001|Reported Event|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
11056751|NCT01340027|BG000|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
11056752|NCT01340027|BG001|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
11056753|NCT01340027|BG002|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
11056754|NCT01340027|BG003|Baseline|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
11056755|NCT01340027|BG004|Baseline|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
11056756|NCT01340027|BG005|Baseline|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
11056757|NCT01340027|BG006|Baseline|Solifenacin 2.5 mg +Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056758|NCT01340027|BG007|Baseline|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056759|NCT01340027|BG008|Baseline|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056760|NCT01340027|BG009|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056761|NCT01340027|BG010|Baseline|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056762|NCT01340027|BG011|Baseline|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056763|NCT01340027|BG012|Baseline|Total|Total of all reporting groups
11056764|NCT01340027|FG000|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
11056765|NCT01340027|FG001|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
11056766|NCT01340027|FG002|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
11056767|NCT01340027|FG003|Participant Flow|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
11056768|NCT01340027|FG004|Participant Flow|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
11056769|NCT01340027|FG005|Participant Flow|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
11056770|NCT01340027|FG006|Participant Flow|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056771|NCT01340027|FG007|Participant Flow|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056772|NCT01340027|FG008|Participant Flow|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056773|NCT01340027|FG009|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056774|NCT01340027|FG010|Participant Flow|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056775|NCT01340027|FG011|Participant Flow|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056776|NCT01340027|OG000|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
11056777|NCT01340027|OG001|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
11056778|NCT01340027|OG002|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
11056779|NCT01340027|OG003|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
11056780|NCT01340027|OG004|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
11056781|NCT01340027|OG005|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
11056782|NCT01340027|OG006|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056783|NCT01340027|OG007|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056784|NCT01340027|OG008|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056785|NCT01340027|OG009|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056786|NCT01340027|OG010|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056787|NCT01340027|OG011|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056788|NCT01340027|EG000|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
11056789|NCT01340027|EG001|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
11056790|NCT01340027|EG002|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
11056791|NCT01340027|EG003|Reported Event|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
11056792|NCT01340027|EG004|Reported Event|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
11056793|NCT01340027|EG005|Reported Event|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
11056794|NCT01340027|EG006|Reported Event|Solifenacin 2.5 mg and Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056795|NCT01340027|EG007|Reported Event|Solifenacin 2.5 mg and Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056796|NCT01340027|EG008|Reported Event|Solifenacin 5 mg and Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056797|NCT01340027|EG009|Reported Event|Solifenacin 5 mg and Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11066799|NCT01393990|BG018|Baseline|Total|Total of all reporting groups
11056798|NCT01340027|EG010|Reported Event|Solifenacin 10 mg and Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
11056799|NCT01340027|EG011|Reported Event|Solifenacin 10 mg and Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
11056800|NCT01340053|BG000|Baseline|Placebo|RDX5791: Capsule, QD
11056801|NCT01340053|BG001|Baseline|Low Dose|RDX5791: Capsule, QD
11056802|NCT01340053|BG002|Baseline|Mid Dose|RDX5791: Capsule, QD
10887279|NCT00499616|FG000|Participant Flow|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
11056803|NCT01340053|BG003|Baseline|High Dose|RDX5791: Capsule, QD
11056804|NCT01340053|BG004|Baseline|Total|Total of all reporting groups
11056805|NCT01340053|FG000|Participant Flow|Placebo|Placebo: Capsule, QD
11056806|NCT01340053|FG001|Participant Flow|10mg|RDX5791: Capsule, QD
11056807|NCT01340053|FG002|Participant Flow|30 mg|RDX5791: Capsule, QD
11056808|NCT01340053|FG003|Participant Flow|100 mg|RDX5791: Capsule, QD
11056809|NCT01340053|OG000|Outcome|Placebo|RDX5791: Capsule, QD
11056810|NCT01340053|OG001|Outcome|Low Dose|RDX5791: Capsule, QD
11056811|NCT01340053|OG002|Outcome|Mid Dose|RDX5791: Capsule, QD
11056812|NCT01340053|OG003|Outcome|High Dose|RDX5791: Capsule, QD
11056813|NCT01340053|EG000|Reported Event|Placebo|RDX5791: Capsule, QD
11056814|NCT01340053|EG001|Reported Event|Low Dose|RDX5791: Capsule, QD
11056815|NCT01340053|EG002|Reported Event|Mid Dose|RDX5791: Capsule, QD
11056816|NCT01340053|EG003|Reported Event|High Dose|RDX5791: Capsule, QD
11056817|NCT01340066|BG000|Baseline|Matching Placebo|At randomization at visit 2, subjects were treated with matching placebo.
11056818|NCT01340066|BG001|Baseline|UISH001|At randomization at visit 2, subjects were treated with UISH001.
11056819|NCT01340066|BG002|Baseline|Total|Total of all reporting groups
11056820|NCT01340066|FG000|Participant Flow|Placebo Run-In|All subjects entered a one week placebo run in period to qualify for the study.
11056821|NCT01340066|FG001|Participant Flow|Placebo|Subjects were randomized at Visit 2
11056822|NCT01340066|FG002|Participant Flow|UISH001|Subjects were randomized at Visit 2
11056823|NCT01340066|OG000|Outcome|Placebo|1 drop Placebo sublingual 3 times/day
11056824|NCT01340066|OG001|Outcome|UISH001|1 drop UISH001 sublingual 3 times/day
11056825|NCT01340066|EG000|Reported Event|Non-Randomized Subjects|Adverse Events (AEs) captured for subjects that were not randomized
11056826|NCT01340066|EG001|Reported Event|UISH001|Subjects were treated with UISH001 during double blind treatment period.
11056827|NCT01340066|EG002|Reported Event|Matching Placebo|Subjects were treated with matching placebo during double blind treatment period.
11056828|NCT01340144|BG000|Baseline|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
11056829|NCT01340144|BG001|Baseline|PFC Sigma HP PS TKA (Total Knee Arthoplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
11056830|NCT01340144|BG002|Baseline|Total|Total of all reporting groups
11056831|NCT01340144|FG000|Participant Flow|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
11056832|NCT01340144|FG001|Participant Flow|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
11056833|NCT01340144|OG000|Outcome|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
11056834|NCT01340144|OG001|Outcome|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
11056835|NCT01340144|EG000|Reported Event|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
11056836|NCT01340144|EG001|Reported Event|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
11056837|NCT01340196|BG000|Baseline|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
11056838|NCT01340196|FG000|Participant Flow|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
11056839|NCT01340196|OG000|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
11056840|NCT01340196|OG001|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
11056841|NCT01340196|OG002|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
11056842|NCT01340196|OG000|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
11056843|NCT01340196|EG000|Reported Event|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
11056844|NCT01340196|EG001|Reported Event|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
11056845|NCT01340196|EG002|Reported Event|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
11056846|NCT01340209|BG000|Baseline|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
11056847|NCT01340209|BG001|Baseline|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
11056848|NCT01340209|BG002|Baseline|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
11056849|NCT01340209|BG003|Baseline|Total|Total of all reporting groups
11056850|NCT01340209|FG000|Participant Flow|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
11056851|NCT01340209|FG001|Participant Flow|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
11056852|NCT01340209|FG002|Participant Flow|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
11056853|NCT01340209|OG000|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
11056854|NCT01340209|OG001|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
11056855|NCT01340209|OG002|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
11056856|NCT01340209|EG000|Reported Event|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
11056857|NCT01340209|EG001|Reported Event|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
11056858|NCT01340209|EG002|Reported Event|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
11056859|NCT01340300|BG000|Baseline|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
11056860|NCT01340300|BG001|Baseline|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
11056861|NCT01340300|BG002|Baseline|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
11056862|NCT01340300|BG003|Baseline|Control|"Educational information~Educational information: educational information"
11056863|NCT01340300|BG004|Baseline|Total|Total of all reporting groups
11056864|NCT01340300|FG000|Participant Flow|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
11056865|NCT01340300|FG001|Participant Flow|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
11056866|NCT01340300|FG002|Participant Flow|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
11056867|NCT01340300|FG003|Participant Flow|Control|"Educational information~Educational information: educational information"
11056868|NCT01340300|OG000|Outcome|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
11056869|NCT01340300|OG001|Outcome|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
11056870|NCT01340300|OG002|Outcome|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
11056871|NCT01340300|OG003|Outcome|Control|"Educational information~Educational information: educational information"
11056872|NCT01340300|EG000|Reported Event|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
11056873|NCT01340300|EG001|Reported Event|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
11056874|NCT01340300|EG002|Reported Event|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
11056875|NCT01340300|EG003|Reported Event|Control|"Educational information~Educational information: educational information"
11056876|NCT01340482|BG000|Baseline|KRN23|"Escalating doses of KRN23 (0.05, 0.10, 0.30 and 0.60 mg/kg) will be administered SC every 28 days (up to 4 doses)~KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor."
11056877|NCT01340482|BG001|Baseline|Bone Substudy KRN23|
11056878|NCT01340482|BG002|Baseline|Bone Substudy Placebo|
11056879|NCT01340482|BG003|Baseline|Total|Total of all reporting groups
11056880|NCT01340482|FG000|Participant Flow|KRN23|"Escalating doses of KRN23 (0.05, 0.10, 0.30 and 0.60 mg/kg) will be administered SC every 28 days (up to 4 doses)~KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor."
11056881|NCT01340482|FG001|Participant Flow|Bone Substudy KRN23|
11056882|NCT01340482|FG002|Participant Flow|Bone Substudy Placebo|
11056883|NCT01340482|OG000|Outcome|KRN23|"Escalating doses of KRN23 (0.05, 0.10, 0.30 and 0.60 mg/kg) will be administered SC every 28 days (up to 4 doses)~KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor."
11056884|NCT01340482|OG001|Outcome|Bone Substudy KRN23|
11056885|NCT01340482|OG002|Outcome|Bone Substudy Placebo|
11056886|NCT01340482|OG000|Outcome|Bone Substudy KRN23|
11056887|NCT01340482|OG001|Outcome|Bone Substudy Placebo|
11056888|NCT01340482|EG000|Reported Event|KRN23|"Escalating doses of KRN23 (0.05, 0.10, 0.30 and 0.60 mg/kg) will be administered SC every 28 days (up to 4 doses)~KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor."
11056889|NCT01340482|EG001|Reported Event|Bone Substudy KRN23|
11056890|NCT01340482|EG002|Reported Event|Bone Substudy Placebo|
11056891|NCT01340495|BG000|Baseline|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
11056892|NCT01340495|FG000|Participant Flow|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
11056893|NCT01340495|OG000|Outcome|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
11056894|NCT01340495|EG000|Reported Event|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
11056895|NCT01340586|BG000|Baseline|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
11056896|NCT01340586|BG001|Baseline|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
11056897|NCT01340586|BG002|Baseline|Total|Total of all reporting groups
11056898|NCT01340586|FG000|Participant Flow|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
11056899|NCT01340586|FG001|Participant Flow|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
11056900|NCT01340586|OG000|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
11056901|NCT01340586|OG001|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
11056902|NCT01340586|OG002|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
11056903|NCT01340586|OG001|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
11056904|NCT01340586|OG000|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
11056905|NCT01340586|OG001|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
11056906|NCT01340586|EG000|Reported Event|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
11056907|NCT01340586|EG001|Reported Event|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
11056908|NCT01340586|EG002|Reported Event|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
11056909|NCT01340625|BG000|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
11056910|NCT01340625|BG001|Baseline|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
11056911|NCT01340625|BG002|Baseline|Total|Total of all reporting groups
11056912|NCT01340625|FG000|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
11056913|NCT01340625|FG001|Participant Flow|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
11056914|NCT01340625|OG000|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
11056915|NCT01340625|OG001|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
11056916|NCT01340625|EG000|Reported Event|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
11056917|NCT01340625|EG001|Reported Event|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
11056918|NCT01340651|BG000|Baseline|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
11056919|NCT01340651|FG000|Participant Flow|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
11056920|NCT01340651|OG000|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
11056921|NCT01340651|OG000|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
11056922|NCT01340651|EG000|Reported Event|Ruxolitinib - Weeks 1-16|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
11056923|NCT01340651|EG001|Reported Event|Ruxolitinib - After Week 16|At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
11056924|NCT01340664|BG000|Baseline|Placebo|Each patient received matching placebo twice daily for 18 weeks.
11056925|NCT01340664|BG001|Baseline|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
11056926|NCT01340664|BG002|Baseline|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
11056927|NCT01340664|BG003|Baseline|Total|Total of all reporting groups
11056928|NCT01340664|FG000|Participant Flow|Placebo|Each patient received matching placebo twice daily for 18 weeks.
11056929|NCT01340664|FG001|Participant Flow|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
11056930|NCT01340664|FG002|Participant Flow|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
11056931|NCT01340664|OG000|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
11056932|NCT01340664|OG001|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
11056933|NCT01340664|OG002|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
11056934|NCT01340664|EG000|Reported Event|Placebo|Each patient received matching placebo twice daily for 18 weeks
11056935|NCT01340664|EG001|Reported Event|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
11056936|NCT01340664|EG002|Reported Event|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
11056937|NCT01340768|BG000|Baseline|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
11056938|NCT01340768|BG001|Baseline|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
11056939|NCT01340768|BG002|Baseline|Total|Total of all reporting groups
11056940|NCT01340768|FG000|Participant Flow|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
11056941|NCT01340768|FG001|Participant Flow|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
11056942|NCT01340768|OG000|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
11056943|NCT01340768|OG001|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
11056944|NCT01340768|EG000|Reported Event|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
11056945|NCT01340768|EG001|Reported Event|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
11056946|NCT01340794|BG000|Baseline|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
11056947|NCT01340794|BG001|Baseline|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
11056948|NCT01340794|BG002|Baseline|Total|Total of all reporting groups
11056949|NCT01340794|FG000|Participant Flow|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
11056950|NCT01340794|FG001|Participant Flow|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
11056951|NCT01340794|OG000|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
11056952|NCT01340794|OG001|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
11056953|NCT01340794|OG000|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
11056954|NCT01340794|OG001|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
11056955|NCT01340794|EG000|Reported Event|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
11056956|NCT01340794|EG001|Reported Event|Treatment: Pazopanib With Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
11056957|NCT01340872|BG000|Baseline|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11056958|NCT01340872|BG001|Baseline|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11056959|NCT01340872|BG002|Baseline|Total|Total of all reporting groups
11056960|NCT01340872|FG000|Participant Flow|ST10|30mg ST10 capsules BD - double-blind phase
11056961|NCT01340872|FG001|Participant Flow|Placebo|Matching placebo for ST10 capsules - double-blind phase
11056962|NCT01340872|FG002|Participant Flow|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
11056963|NCT01340872|FG003|Participant Flow|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
11056964|NCT01340872|OG000|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11056965|NCT01340872|OG001|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11056966|NCT01340872|OG000|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during 12-week double-blind phase.
11056967|NCT01340872|OG001|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during 12-week double-blind phase.
11056968|NCT01340872|OG000|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
11056969|NCT01340872|OG001|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
11056970|NCT01340872|EG000|Reported Event|ST10 - Safety Set, Double-blind Phase|Adverse events reported in the double-blind phase active treatment arm with ST10 (Ferric Maltol). ST10 30 mg capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11056971|NCT01340872|EG001|Reported Event|Placebo - Safety Set, Double-blind Phase|Adverse events reported in the double-blind phase placebo treatment arm. Matching placebo capsules for ST10 taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11056972|NCT01340872|EG002|Reported Event|ST10 Continuation - Safety Set, Open-label Phase|Adverse events reported in the open-label extension phase for continuation of active treatment with ST10 (Ferric Maltol) from the double-blind phase active treatment arm.
11056973|NCT01340872|EG003|Reported Event|Placebo Switch to ST10 Treatment-Safety Set, Open-label Phase|Adverse events reported in the open-label extension phase from those subjects continuing treatment from the double-blind placebo arm; subjects commenced ST10 open-label treatment after completion of the double-blind phase at the Week 12 visit.
11056974|NCT01340898|BG000|Baseline|Nimenrix 3+1 Group|Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056975|NCT01340898|BG001|Baseline|Nimenrix 1+1 Group|Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056976|NCT01340898|BG002|Baseline|Nimenrix Control Group|Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056977|NCT01340898|BG003|Baseline|Total|Total of all reporting groups
11056978|NCT01340898|FG000|Participant Flow|Nimenrix 3+1 Group|Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056979|NCT01340898|FG001|Participant Flow|Nimenrix 1+1 Group|Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056980|NCT01340898|FG002|Participant Flow|Nimenrix Control Group|Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056981|NCT01340898|OG000|Outcome|Nimenrix 3+1 Group|Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056982|NCT01340898|OG000|Outcome|Nimenrix 1+1 Group|Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056983|NCT01340898|OG001|Outcome|Nimenrix Control Group|Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056984|NCT01340898|OG001|Outcome|Nimenrix 1+1 Group|Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056985|NCT01340898|OG002|Outcome|Nimenrix Control Group|Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056986|NCT01340898|EG000|Reported Event|Nimenrix 3+1 Group|Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056987|NCT01340898|EG001|Reported Event|Nimenrix 1+1 Group|Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056988|NCT01340898|EG002|Reported Event|Nimenrix Control Group|Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
11056989|NCT01340937|BG000|Baseline|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056990|NCT01340937|BG001|Baseline|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056991|NCT01340937|BG002|Baseline|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056992|NCT01340937|BG003|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
11056993|NCT01340937|BG004|Baseline|Total|Total of all reporting groups
11056994|NCT01340937|FG000|Participant Flow|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056995|NCT01340937|FG001|Participant Flow|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056996|NCT01340937|FG002|Participant Flow|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056997|NCT01340937|FG003|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
11056998|NCT01340937|OG000|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11056999|NCT01340937|OG001|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057000|NCT01340937|OG002|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057001|NCT01340937|OG003|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
11057002|NCT01340937|OG004|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057003|NCT01340937|OG000|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057004|NCT01340937|OG001|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
11057005|NCT01340937|OG002|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057006|NCT01340937|OG003|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057007|NCT01340937|OG004|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057008|NCT01340937|OG000|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
11057009|NCT01340937|OG001|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057010|NCT01340937|EG000|Reported Event|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
11057011|NCT01340937|EG001|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
11057012|NCT01340976|BG000|Baseline|Part A 0.3 mg/kg LY2787106|Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057013|NCT01340976|BG001|Baseline|Part A 1.0 mg/kg LY2787106|Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057014|NCT01340976|BG002|Baseline|Part A 3.0 mg/kg LY2787106|Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057015|NCT01340976|BG003|Baseline|Part A 10.0 mg/kg LY2787106|Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057016|NCT01340976|BG004|Baseline|Part B 10.0 mg/kg LY2787106|Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
11057017|NCT01340976|BG005|Baseline|Part B 10.0 mg/kg LY2787106+Iron|Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
11057018|NCT01340976|BG006|Baseline|Total|Total of all reporting groups
11057019|NCT01340976|FG000|Participant Flow|Part A 0.3 Milligram Per Kilogram (mg/kg) LY2787106|Part A: Participants received 0.3 mg/kg, LY2787106 intravenously (IV), day 1 of up to three 21-day cycles.
11057020|NCT01340976|FG001|Participant Flow|Part A 1.0 mg/kg LY2787106|Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057021|NCT01340976|FG002|Participant Flow|Part A 3.0 mg/kg LY2787106|Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057022|NCT01340976|FG003|Participant Flow|Part A 10.0 mg/kg LY2787106|Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057023|NCT01340976|FG004|Participant Flow|Part B 10.0 mg/kg LY2787106|Part B: Participants received 10.0 mg/kg LY2787106, IV, on day 1 of up to eight 7-day cycles.
11057024|NCT01340976|FG005|Participant Flow|Part B 10.0 mg/kg LY2787106+Iron|Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
11057025|NCT01340976|OG000|Outcome|Part A 0.3 mg/kg LY2787106|Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057026|NCT01340976|OG001|Outcome|Part A 1.0 mg/kg LY2787106|Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057027|NCT01340976|OG002|Outcome|Part A 3.0 mg/kg LY2787106|Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057028|NCT01340976|OG003|Outcome|Part A 10.0 mg/kg LY2787106|Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057029|NCT01340976|OG004|Outcome|Part B 10 mg/kg LY2787106|Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
11057030|NCT01340976|OG005|Outcome|Part B 10 mg/kg LY2787106+Iron|Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
11057031|NCT01340976|OG000|Outcome|Part B 10 mg/kg LY2787106|Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
11057032|NCT01340976|OG001|Outcome|Part B 10 mg/kg LY2787106+Iron|Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
11057033|NCT01340976|OG004|Outcome|Part B 10.0 mg/kg LY2787106|Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
11057034|NCT01340976|OG005|Outcome|Part B 10.0 mg/kg LY2787106+Iron|Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
11057035|NCT01340976|OG000|Outcome|Part B 10.0 mg/kg LY2787106|Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
11057036|NCT01340976|OG001|Outcome|Part B 10.0 mg/kg LY2787106+Iron|Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
11057037|NCT01340976|EG000|Reported Event|Part A 0.3 mg/kg LY2787106|Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057038|NCT01340976|EG001|Reported Event|Part A 1.0 mg/kg LY2787106|Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057039|NCT01340976|EG002|Reported Event|Part A 3.0 mg/kg LY2787106|Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057040|NCT01340976|EG003|Reported Event|Part A 10.0 mg/kg LY2787106|Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
11057041|NCT01340976|EG004|Reported Event|Part B 10.0 mg/kg LY2787106|Part B: Participants received 10.0 mg/kg of LY2787106, administered IV, on day 1 of up to eight 7-day cycles.
11057042|NCT01340976|EG005|Reported Event|Part B 10.0 mg/kg LY2787106+Iron|Part B: 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
11057043|NCT01341067|BG000|Baseline|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
11057044|NCT01341067|FG000|Participant Flow|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
11057045|NCT01341067|OG000|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
11057046|NCT01341067|EG000|Reported Event|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
11066800|NCT01393990|FG000|Participant Flow|Part A: 10 mg LY2228820 Capsules|10 milligrams (mg) LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11057047|NCT01341301|BG000|Baseline|Allogeneic HSCT|"CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
11057048|NCT01341301|FG000|Participant Flow|Allogeneic HSCT|"CONDITIONING: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive Donor Lymphocyte Infusion (DLI) on day -6 and undergo cluster of differentiation (CD34+) selected allogeneic HSCT on day 0~Graft-versus-host disease (GVHD) PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
11057049|NCT01341301|OG000|Outcome|Allogeneic HSCT|"CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
11057050|NCT01341301|OG000|Outcome|Allogeneic HSCT|"CONDITIONING: Patients undergo Total Body Irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo cluster of differentiation 34 (CD34+) selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
11057051|NCT01341301|OG000|Outcome|Allogeneic HSCT|"CONDITIONING: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo cluster of differentiation (CD34+) selected allogeneic HSCT on day 0~Graft-versus-host disease (GVHD) PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
11057052|NCT01341301|EG000|Reported Event|Allogeneic HSCT|"CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
11057053|NCT01341444|BG000|Baseline|Prevena Incision Management System|"Negative Pressure Therapy Device~Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
11057054|NCT01341444|BG001|Baseline|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier~Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
11057055|NCT01341444|BG002|Baseline|Total|Total of all reporting groups
11057056|NCT01341444|FG000|Participant Flow|Prevena Incision Management System|"Negative Pressure Therapy Device~Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
11057057|NCT01341444|FG001|Participant Flow|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier~Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
11057058|NCT01341444|OG000|Outcome|Prevena Incision Management System|"Negative Pressure Therapy Device~Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
11057059|NCT01341444|OG001|Outcome|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier~Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
11057060|NCT01341444|EG000|Reported Event|Prevena Incision Management System|"Negative Pressure Therapy Device~Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
11057061|NCT01341444|EG001|Reported Event|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier~Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
11057062|NCT01341457|BG000|Baseline|170 mg LY2603618 + Gemcitabine|"Gemcitabine 1000 milligrams per meter squared (mg/m²) administered intravenously (IV) on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057063|NCT01341457|BG001|Baseline|230 mg LY2603618 + Gemcitabine|"Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057064|NCT01341457|BG002|Baseline|Total|Total of all reporting groups
11057065|NCT01341457|FG000|Participant Flow|170 mg LY2603618 + Gemcitabine|"Gemcitabine 1000 milligrams per meter squared (mg/m²) administered intravenously (IV) on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057066|NCT01341457|FG001|Participant Flow|230 mg LY2603618 + Gemcitabine|"Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057067|NCT01341457|OG000|Outcome|170 mg LY2603618 + Gemcitabine|"Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057068|NCT01341457|OG001|Outcome|230 mg LY2603618 + Gemcitabine|"Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057069|NCT01341457|OG000|Outcome|LY2603618 + Gemcitabine|"Gemcitabine 1000 milligrams per meter squared (mg/m²) administered intravenously (IV) on days 1, 8 and 15 of at least one 28-day cycle. 170 or 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057070|NCT01341457|EG000|Reported Event|170 mg LY2603618 + Gemcitabine|"Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057071|NCT01341457|EG001|Reported Event|230 mg LY2603618 + Gemcitabine|"Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.~Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met."
11057072|NCT01341470|BG000|Baseline|Single IV Dose 70 mg LY2495655|Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
11057073|NCT01341470|BG001|Baseline|Multiple SC Dose 17.5 mg LY2495655|17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
11057074|NCT01341470|BG002|Baseline|Multiple SC Dose 140 mg LY2495655|140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
11057075|NCT01341470|BG003|Baseline|Multiple SC Dose 420 mg LY2495655|420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
11057076|NCT01341470|BG004|Baseline|Single IV Dose Placebo|Single placebo dose administered intravenously (IV)
11057077|NCT01341470|BG005|Baseline|Multiple SC Dose Placebo|Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
11057078|NCT01341470|BG006|Baseline|Total|Total of all reporting groups
11057079|NCT01341470|FG000|Participant Flow|Single IV Dose 70 mg LY2495655|Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
11057080|NCT01341470|FG001|Participant Flow|Multiple SC Dose 17.5 mg LY2495655|17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
11057081|NCT01341470|FG002|Participant Flow|Multiple SC Dose 140 mg LY2495655|140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
11057082|NCT01341470|FG003|Participant Flow|Multiple SC Dose 420 mg LY2495655|420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
11057083|NCT01341470|FG004|Participant Flow|Single IV Dose Placebo|Single placebo dose administered intravenously (IV)
11057084|NCT01341470|FG005|Participant Flow|Multiple SC Dose Placebo|Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
11057085|NCT01341470|OG000|Outcome|Single IV Dose 70 mg LY2495655|Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
11057086|NCT01341470|OG001|Outcome|Multiple SC Dose 17.5 mg LY2495655|17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
11057087|NCT01341470|OG002|Outcome|Multiple SC Dose 140 mg LY2495655|140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
11057088|NCT01341470|OG003|Outcome|Multiple SC Dose 420 mg LY2495655|420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
11057089|NCT01341470|OG004|Outcome|Single IV Dose Placebo|Single placebo dose administered intravenously (IV)
11057090|NCT01341470|OG005|Outcome|Multiple SC Dose Placebo|Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
11057091|NCT01341470|OG002|Outcome|Multiple SC Dose 140 mg LY2495655|140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
11057092|NCT01341470|OG003|Outcome|Multiple SC Dose 420 mg LY2495655|420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
11057093|NCT01341470|EG000|Reported Event|Single IV Dose 70 mg LY2495655|Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
11057094|NCT01341470|EG001|Reported Event|Multiple SC Dose 17.5 mg LY2495655|17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
11057095|NCT01341470|EG002|Reported Event|Multiple SC Dose 140 mg LY2495655|140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
11057096|NCT01341470|EG003|Reported Event|Multiple SC Dose 420 mg LY2495655|420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
11057097|NCT01341470|EG004|Reported Event|Single IV Dose Placebo|Single placebo dose administered intravenously (IV)
11057098|NCT01341470|EG005|Reported Event|Multiple SC Dose Placebo|Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
11057099|NCT01341639|BG000|Baseline|PR5I|The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.
11057100|NCT01341639|BG001|Baseline|INFANRIX™ Hexa|The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
11057101|NCT01341639|BG002|Baseline|Total|Total of all reporting groups
11057102|NCT01341639|FG000|Participant Flow|PR5I|The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.
11057103|NCT01341639|FG001|Participant Flow|INFANRIX™ Hexa|The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
11057104|NCT01341639|OG000|Outcome|PR5I|The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.
11057105|NCT01341639|OG001|Outcome|INFANRIX™ Hexa|The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
11057106|NCT01341639|EG000|Reported Event|PR5I|The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.
11057107|NCT01341639|EG001|Reported Event|INFANRIX Hexa|The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
11057108|NCT01341652|BG000|Baseline|GM-CSF Alone|"rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period"
11057109|NCT01341652|BG001|Baseline|pTVG-HP Vaccine With GM-CSF|"pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period"
11057110|NCT01341652|BG002|Baseline|Total|Total of all reporting groups
11057111|NCT01341652|FG000|Participant Flow|GM-CSF Alone|"rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period"
11057112|NCT01341652|FG001|Participant Flow|pTVG-HP Vaccine With GM-CSF|"pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period"
11057113|NCT01341652|OG000|Outcome|GM-CSF Alone|"rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period"
11057114|NCT01341652|OG001|Outcome|pTVG-HP Vaccine With GM-CSF|"pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period"
11057115|NCT01341652|EG000|Reported Event|GM-CSF Alone|"rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period"
11057116|NCT01341652|EG001|Reported Event|pTVG-HP Vaccine With GM-CSF|"pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period"
11057117|NCT01341730|BG000|Baseline|Atorvastatin 20 mg|"After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg group is to take atorvastatin 20 mg and take follow up PET CT in 3 months~Atorvastatin 20mg: 20 mg QD for 3 months"
11057118|NCT01341730|BG001|Baseline|Atorvastatin 20 mg + Pioglitazone 30 mg|"After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg + Pioglitazone 30 mg group is to take atorvastatin 20 mg + pioglitazone 30 mg and take follow up PET CT in 3 months~Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months"
11057119|NCT01341730|BG002|Baseline|Total|Total of all reporting groups
11057120|NCT01341730|FG000|Participant Flow|Atorvastatin 20 mg|"After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg group is to take atorvastatin 20 mg and take follow up PET CT in 3 months~Atorvastatin 20mg: 20 mg QD for 3 months"
11057121|NCT01341730|FG001|Participant Flow|Atorvastatin 20 mg + Pioglitazone 30 mg|"After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg + Pioglitazone 30 mg group is to take atorvastatin 20 mg + pioglitazone 30 mg and take follow up PET CT in 3 months~Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months"
11057122|NCT01341730|OG000|Outcome|Atorvastatin 20 mg|"After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg group is to take atorvastatin 20 mg and take follow up PET CT in 3 months~Atorvastatin 20mg: 20 mg QD for 3 months"
11057123|NCT01341730|OG001|Outcome|Atorvastatin 20 mg + Pioglitazone 30 mg|"After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg + Pioglitazone 30 mg group is to take atorvastatin 20 mg + pioglitazone 30 mg and take follow up PET CT in 3 months~Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months"
11057124|NCT01341730|OG000|Outcome|Atorvastatin 20 mg|Data were not collected
11057125|NCT01341730|OG001|Outcome|Atorvastatin 20 mg + Pioglitazone 30 mg|Data were not collected
11057126|NCT01341730|EG000|Reported Event|Atorvastatin 20 mg|"After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg group is to take atorvastatin 20 mg and take follow up PET CT in 3 months~Atorvastatin 20mg: 20 mg QD for 3 months"
11057127|NCT01341730|EG001|Reported Event|Atorvastatin 20 mg + Pioglitazone 30 mg|"After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg + Pioglitazone 30 mg group is to take atorvastatin 20 mg + pioglitazone 30 mg and take follow up PET CT in 3 months~Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months"
11057128|NCT01341782|BG000|Baseline|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
11057129|NCT01341782|BG001|Baseline|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
11057130|NCT01341782|BG002|Baseline|Total|Total of all reporting groups
11057131|NCT01341782|FG000|Participant Flow|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
11057132|NCT01341782|FG001|Participant Flow|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (intact parathyroid hormone [iPTH] < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
11057133|NCT01341782|OG000|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
11057134|NCT01341782|OG001|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
11057135|NCT01341782|EG000|Reported Event|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
11057136|NCT01341782|EG001|Reported Event|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
11057137|NCT01341912|BG000|Baseline|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
11057138|NCT01341912|FG000|Participant Flow|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
11057139|NCT01341912|OG000|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
11057140|NCT01341912|EG000|Reported Event|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
11057141|NCT01341977|BG000|Baseline|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
11057142|NCT01341977|BG001|Baseline|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
11057143|NCT01341977|BG002|Baseline|Total|Total of all reporting groups
11057144|NCT01341977|FG000|Participant Flow|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
11057145|NCT01341977|FG001|Participant Flow|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
11057146|NCT01341977|OG000|Outcome|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
11057147|NCT01341977|OG001|Outcome|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
11057148|NCT01341977|EG000|Reported Event|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
11057149|NCT01341977|EG001|Reported Event|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
11057150|NCT01341990|BG000|Baseline|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
11057151|NCT01341990|BG001|Baseline|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
11057152|NCT01341990|BG002|Baseline|Total|Total of all reporting groups
11057153|NCT01341990|FG000|Participant Flow|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
11057154|NCT01341990|FG001|Participant Flow|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
11057155|NCT01341990|OG000|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
11057156|NCT01341990|OG001|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
11057157|NCT01341990|EG000|Reported Event|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
11057158|NCT01341990|EG001|Reported Event|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
11057159|NCT01342029|BG000|Baseline|Ranolazine/Placebo|"147 subjects will be enrolled at two clinical sites, with projected 9-10% dropout and anticipated 134 completed subjects.~For Ranolazine first group, subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~For Placebo first group, subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing."
11057160|NCT01342029|FG000|Participant Flow|Ranolazine First, Then Placebo|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.~500-1,000 mg po bid for 2 weeks"
11057161|NCT01342029|FG001|Participant Flow|Placebo First, Then Ranolazine|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Placebo: 500-1,000 mg po bid for 2 weeks"
11057162|NCT01342029|OG000|Outcome|Ranolazine|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.~500-1,000 mg po bid for 2 weeks"
11057163|NCT01342029|OG001|Outcome|Placebo|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Placebo: 500-1,000 mg po bid for 2 weeks"
11057164|NCT01342029|OG000|Outcome|Ranolazine|147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo basel...
11057165|NCT01342029|OG001|Outcome|Placebo|147 subjects with projected 9-10% dropout
11057166|NCT01342029|EG000|Reported Event|Ranolazine|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.~500-1,000 mg po bid for 2 weeks Placebo: 500-1,000 mg po bid for 2 weeks"
11057167|NCT01342029|EG001|Reported Event|Placebo|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.~500-1,000 mg po bid for 2 weeks Placebo: 500-1,000 mg po bid for 2 weeks"
11057168|NCT01342081|BG000|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057169|NCT01342081|BG001|Baseline|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057170|NCT01342081|BG002|Baseline|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
11057171|NCT01342081|BG003|Baseline|Total|Total of all reporting groups
11057172|NCT01342081|FG000|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057173|NCT01342081|FG001|Participant Flow|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057174|NCT01342081|FG002|Participant Flow|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
11057175|NCT01342081|OG000|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057176|NCT01342081|OG001|Outcome|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057177|NCT01342081|OG002|Outcome|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
11057178|NCT01342081|EG000|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057179|NCT01342081|EG001|Reported Event|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057180|NCT01342081|EG002|Reported Event|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
11057181|NCT01342094|BG000|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057182|NCT01342094|BG001|Baseline|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
11057183|NCT01342094|BG002|Baseline|Total|Total of all reporting groups
11057184|NCT01342094|FG000|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057185|NCT01342094|FG001|Participant Flow|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
11057186|NCT01342094|OG000|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057187|NCT01342094|OG001|Outcome|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
11057188|NCT01342094|EG000|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
11057189|NCT01342094|EG001|Reported Event|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
11057190|NCT01342107|BG000|Baseline|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
11057191|NCT01342107|BG001|Baseline|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
11057192|NCT01342107|BG002|Baseline|Total|Total of all reporting groups
11057193|NCT01342107|FG000|Participant Flow|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
11057194|NCT01342107|FG001|Participant Flow|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
11057195|NCT01342107|OG000|Outcome|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
11057196|NCT01342107|OG001|Outcome|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
11057197|NCT01342107|EG000|Reported Event|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
11057198|NCT01342107|EG001|Reported Event|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
11057199|NCT01342172|BG000|Baseline|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
11057200|NCT01342172|FG000|Participant Flow|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
11057201|NCT01342172|OG000|Outcome|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
11057202|NCT01342172|EG000|Reported Event|Lenalidomide for Cycle 1|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
11057203|NCT01342172|EG001|Reported Event|Phase 2|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
11057204|NCT01342211|BG000|Baseline|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057205|NCT01342211|BG001|Baseline|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057206|NCT01342211|BG002|Baseline|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057207|NCT01342211|BG003|Baseline|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057208|NCT01342211|BG004|Baseline|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057209|NCT01342211|BG005|Baseline|Total|Total of all reporting groups
11057210|NCT01342211|FG000|Participant Flow|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057211|NCT01342211|FG001|Participant Flow|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057212|NCT01342211|FG002|Participant Flow|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057213|NCT01342211|FG003|Participant Flow|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057214|NCT01342211|FG004|Participant Flow|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057215|NCT01342211|OG000|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057216|NCT01342211|OG001|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057217|NCT01342211|OG002|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057218|NCT01342211|OG003|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057219|NCT01342211|OG004|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057220|NCT01342211|OG000|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057221|NCT01342211|OG001|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057222|NCT01342211|OG002|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057223|NCT01342211|OG003|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057224|NCT01342211|EG000|Reported Event|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057225|NCT01342211|EG001|Reported Event|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057226|NCT01342211|EG002|Reported Event|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057227|NCT01342211|EG003|Reported Event|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057228|NCT01342211|EG004|Reported Event|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
11057229|NCT01342341|BG000|Baseline|Parafon Forte First, Then Placebo|Participants will receive either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (1st intervention; 14 days), followed by a washout (7 days), and then followed by placebo (2nd intervention; 14 days).
11057230|NCT01342341|BG001|Baseline|Placebo First, Then Parafon Forte|Participants will receive placebo (1st intervention; 14days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days).
11057231|NCT01342341|BG002|Baseline|Total|Total of all reporting groups
11057232|NCT01342341|FG000|Participant Flow|Parafon Forte First, Then Placebo|Participants will receive either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (1st intervention; 14 days), followed by a washout (7 days), and then followed by placebo (2nd intervention; 14 days).
11057233|NCT01342341|FG001|Participant Flow|Placebo First, Then Parafon Forte|Participants will receive placebo (1st intervention; 14days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days).
11057234|NCT01342341|OG000|Outcome|Parafon Forte|Participants received either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (1st intervention; 14 days), followed by a washout (7 days), and then followed by placebo (2nd intervention; 14 days).
11057235|NCT01342341|OG001|Outcome|Placebo|Participants received placebo (1st intervention; 14 days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days).
11057236|NCT01342341|EG000|Reported Event|Parafon Forte|"This is a cross-over study. Adverse Events Arms/Groups are reported per intervention. Group reflects **all** participants who received Parafon Forte intervention during the study."
11057237|NCT01342341|EG001|Reported Event|Placebo|"This is a cross-over study. Adverse Events Arms/Groups are reported per intervention. Group reflects **all** participants who received Placebo intervention during the study."
11057238|NCT01342367|BG000|Baseline|SOC Cohort|the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks
11057239|NCT01342367|BG001|Baseline|Oral ADT Group|Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks
11057240|NCT01342367|BG002|Baseline|Total|Total of all reporting groups
11057241|NCT01342367|FG000|Participant Flow|SOC Cohort|the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks
11057242|NCT01342367|FG001|Participant Flow|Oral ADT Group|Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks
11057243|NCT01342367|OG000|Outcome|SOC Cohort|the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks
11057244|NCT01342367|OG001|Outcome|Oral ADT Group|Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks
11057245|NCT01342367|EG000|Reported Event|SOC Cohort|the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks
11057246|NCT01342367|EG001|Reported Event|Oral ADT Group|Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks
11057247|NCT01342445|BG000|Baseline|ADHD Participants|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg LDX in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition.
11057248|NCT01342445|BG001|Baseline|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug.
11057249|NCT01342445|BG002|Baseline|Total|Total of all reporting groups
11057250|NCT01342445|FG000|Participant Flow|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug.
11057251|NCT01342445|FG001|Participant Flow|Attention-deficit/Hyperactivity Disorder (ADHD) Participants|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg lisdexamfetamine dimesylate (LDX) in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. Each phase was conducted for 1 week, and therefore, the total trial took place over 5 weeks and was able to be completed during a single semester. Participants ingested one pill per day on awakening.
11057252|NCT01342445|OG000|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
11057253|NCT01342445|OG001|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
11057254|NCT01342445|OG002|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
11057255|NCT01342445|OG003|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
11057256|NCT01342445|EG000|Reported Event|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
11057257|NCT01342445|EG001|Reported Event|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
11057258|NCT01342445|EG002|Reported Event|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
11057259|NCT01342445|EG003|Reported Event|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
11057260|NCT01342458|BG000|Baseline|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
11057261|NCT01342458|BG001|Baseline|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
11057262|NCT01342458|BG002|Baseline|Total|Total of all reporting groups
11057263|NCT01342458|FG000|Participant Flow|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
11057264|NCT01342458|FG001|Participant Flow|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
11057265|NCT01342458|OG000|Outcome|Intervention Group|WOMAC pain subscale
11057266|NCT01342458|OG001|Outcome|Control Group|WOMAC pain subscale
11057267|NCT01342458|OG000|Outcome|Intervention Group|WOMAC stiffness subscale
11057268|NCT01342458|OG001|Outcome|Control Group|WOMAC stiffness subscale
11057269|NCT01342458|OG000|Outcome|Intervention Group|WOMAC Physical function subscale
11057270|NCT01342458|OG001|Outcome|Control Group|WOMAC Physical function subscale
11057271|NCT01342458|OG000|Outcome|Intervention Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
11057272|NCT01342458|OG001|Outcome|Control Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
11057273|NCT01342458|OG000|Outcome|Intervention Group|Global score of the Lequesne´s questionaire algo-functional.
11057274|NCT01342458|OG001|Outcome|Control Group|Global score of the Lequesne´s questionaire algo-functional.
11057275|NCT01342458|OG000|Outcome|Intervention Group|Six-minute walk test
11057276|NCT01342458|OG001|Outcome|Control Group|Six-minute walk test
11057277|NCT01342458|OG000|Outcome|Intervention Group|Knee adduction moment (KAM) first peak
11057278|NCT01342458|OG001|Outcome|Control Group|Knee adduction moment (KAM) first peak
11057279|NCT01342458|OG000|Outcome|Intervention Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
11057280|NCT01342458|OG001|Outcome|Control Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
11057281|NCT01342458|EG000|Reported Event|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
11057282|NCT01342458|EG001|Reported Event|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
11057283|NCT01342471|BG000|Baseline|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
11057284|NCT01342471|BG001|Baseline|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
11057285|NCT01342471|BG002|Baseline|Total|Total of all reporting groups
11057286|NCT01342471|FG000|Participant Flow|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
11066801|NCT01393990|FG001|Participant Flow|Part A: 20 mg LY2228820 Capsules|20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11057287|NCT01342471|FG001|Participant Flow|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
11057288|NCT01342471|OG000|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
11057289|NCT01342471|OG001|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
11057290|NCT01342471|EG000|Reported Event|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
11057291|NCT01342471|EG001|Reported Event|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
11057292|NCT01342484|BG000|Baseline|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
11057293|NCT01342484|BG001|Baseline|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
11057294|NCT01342484|BG002|Baseline|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
11057295|NCT01342484|BG003|Baseline|Total|Total of all reporting groups
11057296|NCT01342484|FG000|Participant Flow|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
11057297|NCT01342484|FG001|Participant Flow|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
11057298|NCT01342484|FG002|Participant Flow|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
11057299|NCT01342484|OG000|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
11057300|NCT01342484|OG001|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
11057301|NCT01342484|OG002|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
11057302|NCT01342484|EG000|Reported Event|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
11057303|NCT01342484|EG001|Reported Event|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
11057304|NCT01342484|EG002|Reported Event|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
11057305|NCT01342510|BG000|Baseline|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
11057306|NCT01342510|BG001|Baseline|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
11057307|NCT01342510|BG002|Baseline|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
11057308|NCT01342510|BG003|Baseline|Control|0.9% saline in a 10 cc syringe
11057309|NCT01342510|BG004|Baseline|Total|Total of all reporting groups
11057310|NCT01342510|FG000|Participant Flow|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
11057311|NCT01342510|FG001|Participant Flow|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
11057312|NCT01342510|FG002|Participant Flow|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
11057313|NCT01342510|FG003|Participant Flow|Control|0.9% saline in a 10 cc syringe
11066802|NCT01393990|FG002|Participant Flow|Part A: 40 mg LY2228820 Capsules|40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11057314|NCT01342510|OG000|Outcome|Lidocaine|"Lidocaine 50 mg in a 10 cc syringe~Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.~Lidocaine: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection."
11057315|NCT01342510|OG001|Outcome|Magnesium|"Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe~Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection."
11057316|NCT01342510|OG002|Outcome|Lidocaine/Magnesium|"Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe~Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.~Lidocaine/Magnesium: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection."
11057317|NCT01342510|OG003|Outcome|Control|"0.9% saline in a 10 cc syringe~Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.~Control: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection."
11057318|NCT01342510|OG000|Outcome|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
11057319|NCT01342510|OG001|Outcome|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
11057320|NCT01342510|OG002|Outcome|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
11057321|NCT01342510|OG003|Outcome|Control|0.9% saline in a 10 cc syringe
11057322|NCT01342510|EG000|Reported Event|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
11057323|NCT01342510|EG001|Reported Event|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
11057324|NCT01342510|EG002|Reported Event|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
11057325|NCT01342510|EG003|Reported Event|Control|0.9% saline in a 10 cc syringe
11057326|NCT01342523|BG000|Baseline|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
11057327|NCT01342523|BG001|Baseline|CIS/No Loz/No Email/Lite Website/Brief Booklet|
11057328|NCT01342523|BG002|Baseline|no CIS/Loz/No Email/Lite Website/Brief Booklet|
11057329|NCT01342523|BG003|Baseline|No CIS/no Loz/Email/Lite Website/Brief Booklet|
11057330|NCT01342523|BG004|Baseline|No CIS/No Loz/No Email/Full Website/Brief Booklet|
11057331|NCT01342523|BG005|Baseline|No CIS/No Loz/No Email/Lite Website/Full Booklet|
11057332|NCT01342523|BG006|Baseline|CIS/Loz/No Email/Lite Website/Brief Booklet|
11057333|NCT01342523|BG007|Baseline|CIS/No Loz/Emails/Lite Website/Brief Booklet|
11057334|NCT01342523|BG008|Baseline|CIS/No Loz/no Email/Full Website/Brief Booklet|
11057335|NCT01342523|BG009|Baseline|CIS/No Loz/no Email/Lite Website/Full Booklet|
11057336|NCT01342523|BG010|Baseline|No CIS/Loz/Emails/Lite Website/Brief Booklet|
11057337|NCT01342523|BG011|Baseline|No CIS/Loz/No Emails/Lite Website/Full Booklet|
11057338|NCT01342523|BG012|Baseline|No CIS/Loz/No Emails/Full Website/Lite Booklet|
11057339|NCT01342523|BG013|Baseline|no CIS/no Loz/Emails/Full Website/Brief Booklet|
11057340|NCT01342523|BG014|Baseline|no CIS/no Loz/Emails/Lite Web/Full Booklet|
11057341|NCT01342523|BG015|Baseline|no CIS/no Loz/no Email/Full Website/Full Booklet|
11057342|NCT01342523|BG016|Baseline|CIS/Loz/Emails/Lite Website/Brief Booklet|
11057343|NCT01342523|BG017|Baseline|CIS/Loz/no Email/Full Website/Brief Booklet|
11057344|NCT01342523|BG018|Baseline|CIS/Loz/no Email/Lite Website/Full Booklet|
11057345|NCT01342523|BG019|Baseline|CIS/no Loz/Emails/Full Website/Brief Booklet|
11057346|NCT01342523|BG020|Baseline|CIS/no Loz/Emails/Lite Website/Full Booklet|
11057347|NCT01342523|BG021|Baseline|CIS/no Loz/no Email/Full Website/Full Booklet|
11057348|NCT01342523|BG022|Baseline|No CIS/Loz/Emails/Full Website/Brief Booklet|
11057349|NCT01342523|BG023|Baseline|No CIS/Loz/Emails/Lite Website/Full Booklet|
11057350|NCT01342523|BG024|Baseline|No CIS/Loz/no Emails/Full Website/Full Booklet|
11057351|NCT01342523|BG025|Baseline|no CIS/no Loz/Emails/Full Website/Full Booklet|
11057352|NCT01342523|BG026|Baseline|CIS/Loz/Emails/Full Website/Brief Booklet|
11057353|NCT01342523|BG027|Baseline|CIS/Loz/Emails/Lite Website/Full Booklet|
11057354|NCT01342523|BG028|Baseline|No CIS/Loz/Emails/Full Website/Full Booklet|
11057355|NCT01342523|BG029|Baseline|CIS/no Loz/Emails/Full Website/Full Booklet|
11057356|NCT01342523|BG030|Baseline|CIS/Loz/no Emails/Full Website/Full Booklet|
11057357|NCT01342523|BG031|Baseline|CIS/Loz/Emails/Full Website/Full Booklet|
11057358|NCT01342523|BG032|Baseline|Total|Total of all reporting groups
11057359|NCT01342523|FG000|Participant Flow|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
11057360|NCT01342523|FG001|Participant Flow|CIS/No Loz/No Email/Lite Website/Brief Booklet|
11057361|NCT01342523|FG002|Participant Flow|no CIS/Loz/No Email/Lite Website/Brief Booklet|
11057362|NCT01342523|FG003|Participant Flow|No CIS/no Loz/Email/Lite Website/Brief Booklet|
11057363|NCT01342523|FG004|Participant Flow|No CIS/No Loz/No Email/Full Website/Brief Booklet|
11057364|NCT01342523|FG005|Participant Flow|No CIS/No Loz/No Email/Lite Website/Full Booklet|
11057365|NCT01342523|FG006|Participant Flow|CIS/Loz/No Email/Lite Website/Brief Booklet|
11057366|NCT01342523|FG007|Participant Flow|CIS/No Loz/Emails/Lite Website/Brief Booklet|
11057367|NCT01342523|FG008|Participant Flow|CIS/No Loz/no Email/Full Website/Brief Booklet|
11057368|NCT01342523|FG009|Participant Flow|CIS/No Loz/no Email/Lite Website/Full Booklet|
11057369|NCT01342523|FG010|Participant Flow|No CIS/Loz/Emails/Lite Website/Brief Booklet|
11057370|NCT01342523|FG011|Participant Flow|No CIS/Loz/No Emails/Lite Website/Full Booklet|
11057371|NCT01342523|FG012|Participant Flow|No CIS/Loz/No Emails/Full Website/Lite Booklet|
11057372|NCT01342523|FG013|Participant Flow|no CIS/no Loz/Emails/Full Website/Brief Booklet|
11057373|NCT01342523|FG014|Participant Flow|no CIS/no Loz/Emails/Lite Web/Full Booklet|
11057374|NCT01342523|FG015|Participant Flow|no CIS/no Loz/no Email/Full Website/Full Booklet|
11057375|NCT01342523|FG016|Participant Flow|CIS/Loz/Emails/Lite Website/Brief Booklet|
11057376|NCT01342523|FG017|Participant Flow|CIS/Loz/no Email/Full Website/Brief Booklet|
11057377|NCT01342523|FG018|Participant Flow|CIS/Loz/no Email/Lite Website/Full Booklet|
11057378|NCT01342523|FG019|Participant Flow|CIS/no Loz/Emails/Full Website/Brief Booklet|
11057379|NCT01342523|FG020|Participant Flow|CIS/no Loz/Emails/Lite Website/Full Booklet|
11057380|NCT01342523|FG021|Participant Flow|CIS/no Loz/no Email/Full Website/Full Booklet|
11057381|NCT01342523|FG022|Participant Flow|No CIS/Loz/Emails/Full Website/Brief Booklet|
11057382|NCT01342523|FG023|Participant Flow|No CIS/Loz/Emails/Lite Website/Full Booklet|
11057383|NCT01342523|FG024|Participant Flow|No CIS/Loz/no Emails/Full Website/Full Booklet|
11057384|NCT01342523|FG025|Participant Flow|no CIS/no Loz/Emails/Full Website/Full Booklet|
11057385|NCT01342523|FG026|Participant Flow|CIS/Loz/Emails/Full Website/Brief Booklet|
11057386|NCT01342523|FG027|Participant Flow|CIS/Loz/Emails/Lite Website/Full Booklet|
11057387|NCT01342523|FG028|Participant Flow|No CIS/Loz/Emails/Full Website/Full Booklet|
11057388|NCT01342523|FG029|Participant Flow|CIS/no Loz/Emails/Full Website/Full Booklet|
11057389|NCT01342523|FG030|Participant Flow|CIS/Loz/no Emails/Full Website/Full Booklet|
11057390|NCT01342523|FG031|Participant Flow|CIS/Loz/Emails/Full Website/Full Booklet|
11057391|NCT01342523|OG000|Outcome|"Cancer Information Service Counseling (CIS)"|"Participants in this intervention group received telephone quitline counseling from the Cancer Information Service (CIS). These proactive calls initiated by CIS included an initial call (30 min), occurring within 3 days of enrollment, plus 4 additional counseling calls (up to 15 min each) scheduled to occur on the quit day or the day after, and then weekly for the next 3 weeks. The content of the counseling calls focused initially on motivating quitting and then setting a quit date, providing support, building self-efficacy, and skill training. The CIS intervention group will be compared to a No CIS group. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (CIS) and the other half to the No CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 453 participants were randomized to CIS and 581 to the No CIS group."
11057392|NCT01342523|OG001|Outcome|"No Cancer Information Service Counseling (No CIS)"|"Participants in this intervention group did not receive telephone quitline counseling from the Cancer Information Service (CIS). This intervention group will be compared to an intervention group that did receive telephone quitline counseling from the CIS. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (No CIS) and the other half to the CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 581 participants were randomized to No CIS group and 453 to the CIS group."
11057393|NCT01342523|OG002|Outcome|Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks)|Participants in this intervention group received a 2-week starter package of nicotine mini-lozenges, with dose based on time to since first cigarette of the day as per package instructions. Each package contained 2 mini-lozenge dispensers (162 lozenges total) and instructions on proper use. Approximately half of the total sample of 1034 participants was randomized to receive the 2-week supply of mini-lozenges; the other half received no mini-lozenges.
11057394|NCT01342523|OG003|Outcome|No Nicotine Replacement Therapy|Participants in this intervention group received no nicotine replacement therapy (NRT), i.e., no nicotine mini-lozenges. Approximately half of the total sample of 1034 participants was randomized to receive no NRT; the other half a 2-week supply of nicotine mini-lozenges.
11057395|NCT01342523|OG004|Outcome|Email Messaging|Participants Email Messaging intervention group received brief email messages that could be accessed by any computer or mobile device that allowed email receipt. Messages were intended to provide: (1) Motivation/encouragement; (2) Quitting tips and information; (3) Adherence/education prompts (to use available resources as recommended), and (4) relapse prevention content. These emailed messages were sent twice/day for two weeks, once/day for an additional month, and then one every 3rd day for an additional 6 weeks (constituting a 3-month-long intervention). Approximately half of the total sample of 1034 participants was randomized to receive Email Messaging; the other half received no Email Messaging.
11057396|NCT01342523|OG005|Outcome|No Email Messaging|Participants in this intervention group received no Email Messaging. Approximately half of the total sample of 1034 participants was randomized to receive no Email Messaging; the other half received 3 months of Email Messaging.
11066803|NCT01393990|FG003|Participant Flow|Part A: 65 mg LY2228820 Capsules|65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11057397|NCT01342523|OG006|Outcome|Full SmokeFree.Gov Website|Participants in the Full SmokeFree.gov website intervention group received the standard smokefree.gov website content that included resources to motivate quitting and a step-by-step quitting guide that provided a skill-based intervention for preparing to quit, quitting, and maintaining abstinence. In addition, the active website offered encouragement and support, motivational information, and interactive features and referral links. The active website did not include direct interaction with users (e.g. live help) or interactive audio or video content. User-engagement features included task charts for behavior change, self-monitoring tools (e.g. for cravings and self-assessment), creation of a personal calendar, links to a quitline or to a counselor via text message for live help and social support through social media. No tailoring, feedback or outbound reminders were in use. Approximately half of the total sample of 1034 participants was randomized to receive the Full Smoke
11057398|NCT01342523|OG007|Outcome|Lite SmokeFree.Gov Website|"Participants in the Lite SmokeFree.gov Website intervention group received received the Lite version of the website (developed by the investigators for this research) that included information about smoking and health such as benefits of quitting and information about withdrawal, medications and stress, but contained no interactive features or content that would support skill training. The look and graphics directly mirrored the full smokefree.gov website, but the number of web pages was reduced from over 50 to 16, and external links to resources were virtually eliminated. Approximately half of the total sample of 1034 participants was randomized to receive theLite SmokeFree.gov Website; the other half received the Full SmokeFree.gov Website."
11057399|NCT01342523|OG008|Outcome|Full Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received the National Cancer Institute's 36-page Clearing the Air brochure (www.smokefree.gov/pubs/clearing_the_air.pdf), containing a detailed guide for preparing to quit, quitting, and preventing relapse as well as suggested resources. Approximately half of the total sample of 1034 participants was randomized to receive the Full Cessation Booklet; the other half received a Brief Cessation Booklet."
11057400|NCT01342523|OG009|Outcome|Brief Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received a 12-page booklet developed by the investigators. The content of this booklet was the same as contained in the 36-page Clearing the Air booklet except that information directly relevant to coping skill training (identification of smoking triggers, making coping plans) was removed. Approximately half of the total sample of 1034 participants was randomized to receive the Brief Cessation Booklet; the other half received the Full Cessation Booklet."
11057401|NCT01342523|EG000|Reported Event|Lozenge|2 week supply of nicotine mini-lozenge. This is the only study arm for which adverse events were appropriate to be collected and analyzed, since all other arms did not involve interventions that could generate an adverse event report.
11057402|NCT01342549|BG000|Baseline|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
11057403|NCT01342549|BG001|Baseline|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
11057404|NCT01342549|BG002|Baseline|Total|Total of all reporting groups
11057405|NCT01342549|FG000|Participant Flow|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
11057406|NCT01342549|FG001|Participant Flow|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
11057407|NCT01342549|OG000|Outcome|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
11057408|NCT01342549|OG001|Outcome|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
11057409|NCT01342549|EG000|Reported Event|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
11057410|NCT01342549|EG001|Reported Event|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
11057411|NCT01342640|BG000|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
11057412|NCT01342640|FG000|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's hemoglobin (Hb) level.
11057413|NCT01342640|OG000|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
11057414|NCT01342640|EG000|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
11057415|NCT01342666|BG000|Baseline|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
11057416|NCT01342666|BG001|Baseline|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
11057417|NCT01342666|BG002|Baseline|Total|Total of all reporting groups
11057418|NCT01342666|FG000|Participant Flow|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
11057419|NCT01342666|FG001|Participant Flow|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
11057420|NCT01342666|OG000|Outcome|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
11057421|NCT01342666|OG001|Outcome|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
11057422|NCT01342666|EG000|Reported Event|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
11057423|NCT01342666|EG001|Reported Event|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
11057424|NCT01342757|BG000|Baseline|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
11057425|NCT01342757|FG000|Participant Flow|Vorinostat and Temozolomide|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
11057426|NCT01342757|OG000|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
11057427|NCT01342757|EG000|Reported Event|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
11057428|NCT01342770|BG000|Baseline|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
11057429|NCT01342770|FG000|Participant Flow|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
11057430|NCT01342770|OG000|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
11057431|NCT01342770|EG000|Reported Event|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
11057432|NCT01342796|BG000|Baseline|aTIV Group|Subjects received two doses (0.25mL) of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.
11057433|NCT01342796|BG001|Baseline|TIV Group|Subjects received two doses (0.25mL) of inactivated, subunit influenza vaccine administered four weeks apart.
11057434|NCT01342796|BG002|Baseline|Total|Total of all reporting groups
11057435|NCT01342796|FG000|Participant Flow|aTIV Group|Subjects received two doses (0.25mL) of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.
11057436|NCT01342796|FG001|Participant Flow|TIV Group|Subjects received two doses (0.25mL) of inactivated, subunit influenza vaccine administered four weeks apart.
11057437|NCT01342796|OG000|Outcome|aTIV Group|Subjects received two doses of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.
11057438|NCT01342796|OG001|Outcome|TIV Group|Subjects received two doses of inactivated, subunit influenza vaccine administered four weeks apart.
11057439|NCT01342796|EG000|Reported Event|aTIV (6 to <36 Months)|
11057440|NCT01342796|EG001|Reported Event|TIV (6 to <36 Months)|
11057441|NCT01342887|BG000|Baseline|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
11057442|NCT01342887|FG000|Participant Flow|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
11057443|NCT01342887|OG000|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
11057444|NCT01342887|EG000|Reported Event|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
11057445|NCT01342913|BG000|Baseline|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11057446|NCT01342913|BG001|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11057447|NCT01342913|BG002|Baseline|Total|Total of all reporting groups
11057448|NCT01342913|FG000|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
11057449|NCT01342913|FG001|Participant Flow|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11057450|NCT01342913|FG002|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11057451|NCT01342913|OG000|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11057452|NCT01342913|OG001|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11057453|NCT01342913|EG000|Reported Event|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
11057454|NCT01342913|EG001|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
11057455|NCT01342926|BG000|Baseline|Placebo|Placebo via intravenous infusion
11057456|NCT01342926|BG001|Baseline|GSK933776 3 mg/kg|3 mg/kg administration of GSK933776 via intravenous infusion
11057457|NCT01342926|BG002|Baseline|GSK933776 6 mg/kg|6 mg/kg administration of GSK933776 via intravenous infusion
11057458|NCT01342926|BG003|Baseline|GSK933776 15 mg/kg|15 mg/kg administration of GSK933776 via intravenous infusion
11057459|NCT01342926|BG004|Baseline|Total|Total of all reporting groups
11057460|NCT01342926|FG000|Participant Flow|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
11057461|NCT01342926|FG001|Participant Flow|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
11057462|NCT01342926|FG002|Participant Flow|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
11057463|NCT01342926|FG003|Participant Flow|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
11057464|NCT01342926|OG000|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
11057465|NCT01342926|OG001|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
11057466|NCT01342926|OG002|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
11057467|NCT01342926|OG003|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
11057468|NCT01342926|EG000|Reported Event|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
11057469|NCT01342926|EG001|Reported Event|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
11057470|NCT01342926|EG002|Reported Event|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
11057471|NCT01342926|EG003|Reported Event|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
11057472|NCT01342965|BG000|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
11057473|NCT01342965|BG001|Baseline|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
11057474|NCT01342965|BG002|Baseline|Total|Total of all reporting groups
11057475|NCT01342965|FG000|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
11057476|NCT01342965|FG001|Participant Flow|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
11057477|NCT01342965|OG000|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
11057478|NCT01342965|OG001|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
11057479|NCT01342965|EG000|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
11057480|NCT01342965|EG001|Reported Event|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
11057481|NCT01343004|BG000|Baseline|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
11057482|NCT01343004|BG001|Baseline|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
11057483|NCT01343004|BG002|Baseline|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
11057484|NCT01343004|BG003|Baseline|Total|Total of all reporting groups
11057485|NCT01343004|FG000|Participant Flow|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
11057486|NCT01343004|FG001|Participant Flow|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
11057487|NCT01343004|FG002|Participant Flow|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
11057488|NCT01343004|OG000|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
11057489|NCT01343004|OG001|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
11057490|NCT01343004|OG002|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
11057491|NCT01343004|EG000|Reported Event|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
11057492|NCT01343004|EG001|Reported Event|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
11057493|NCT01343004|EG002|Reported Event|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
11057494|NCT01343043|BG000|Baseline|Cohort 1: High NY-ESO-1 Expression Treated With Regimen A|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057495|NCT01343043|BG001|Baseline|Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A|Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
11057496|NCT01343043|BG002|Baseline|Cohort 3: High NY-ESO-1 Expression Treated With Regimen B|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057497|NCT01343043|BG003|Baseline|Cohort 4: High NY-ESO-1 Expression Treated With Regimen C|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057498|NCT01343043|BG004|Baseline|Total|Total of all reporting groups
11057499|NCT01343043|FG000|Participant Flow|Cohort 1: High NY-ESO-1 Expression Treated With Regimen A|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057500|NCT01343043|FG001|Participant Flow|Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A|Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
11057501|NCT01343043|FG002|Participant Flow|Cohort 3: High NY-ESO-1 Expression Treated With Regimen B|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057502|NCT01343043|FG003|Participant Flow|Cohort 4: High NY-ESO-1 Expression Treated With Regimen C|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057503|NCT01343043|OG000|Outcome|Cohort 1: High NY-ESO-1 Expression Treated With Regimen A|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057504|NCT01343043|OG001|Outcome|Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A|Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
11057505|NCT01343043|OG002|Outcome|Cohort 3: High NY-ESO-1 Expression Treated With Regimen B|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057506|NCT01343043|OG003|Outcome|Cohort 4: High NY-ESO-1 Expression Treated With Regimen C|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057507|NCT01343043|OG000|Outcome|Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A|Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
11057508|NCT01343043|OG000|Outcome|Cohort 3: High NY-ESO-1 Expression Treated With Regimen B|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057509|NCT01343043|OG000|Outcome|Cohort 4: High NY-ESO-1 Expression Treated With Regimen C|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057510|NCT01343043|EG000|Reported Event|Cohort 1: High NY-ESO-1 Expression Treated With Regimen A|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057511|NCT01343043|EG001|Reported Event|Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A|Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells.
11057512|NCT01343043|EG002|Reported Event|Cohort 3: High NY-ESO-1 Expression Treated With Regimen B|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057513|NCT01343043|EG003|Reported Event|Cohort 4: High NY-ESO-1 Expression Treated With Regimen C|Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
11057514|NCT01343056|BG000|Baseline|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057515|NCT01343056|BG001|Baseline|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11066804|NCT01393990|FG004|Participant Flow|Part A: 90 mg LY2228820 Capsules|90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11057516|NCT01343056|BG002|Baseline|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057517|NCT01343056|BG003|Baseline|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057518|NCT01343056|BG004|Baseline|Total|Total of all reporting groups
11057519|NCT01343056|FG000|Participant Flow|Office Staff Follow up of Diabetes Education|A designee in the office shall be assigned to follow up with the patient for goal attainment. It was suggested that they phone the participant monthly. Staff also received training on how best to provide support to patients.
11057520|NCT01343056|FG001|Participant Flow|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer met with the participant at their 6 week follow up visit and then called the participant monthly to monitor goal attainment."
11057521|NCT01343056|FG002|Participant Flow|Usual Care|ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call was made by a diabetes educator.
11057522|NCT01343056|FG003|Participant Flow|Educator Support Follow up|A diabetes educator provided support to patients with periodic phone calls. Diabetes educators received training in ways to improve patient empowerment and best support their patients following diabetes education.
11057523|NCT01343056|OG000|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057524|NCT01343056|OG001|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057525|NCT01343056|OG002|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057526|NCT01343056|OG003|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057527|NCT01343056|OG000|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
11057528|NCT01343056|OG001|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
11057529|NCT01343056|OG002|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
11057530|NCT01343056|OG003|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.~Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
11057531|NCT01343056|EG000|Reported Event|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057532|NCT01343056|EG001|Reported Event|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057533|NCT01343056|EG002|Reported Event|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057534|NCT01343056|EG003|Reported Event|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
11057535|NCT01343082|BG000|Baseline|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
11057536|NCT01343082|FG000|Participant Flow|Allocated to Tafluprost|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) .
11057537|NCT01343082|FG001|Participant Flow|Allocated to Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation).
11057538|NCT01343082|FG002|Participant Flow|Allocated to Tafluprost + Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%.
11057539|NCT01343082|OG000|Outcome|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
11057540|NCT01343082|EG000|Reported Event|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
11057541|NCT01343095|BG000|Baseline|Usual Care|Usual Care between 10pm-6am
11057542|NCT01343095|BG001|Baseline|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
11057543|NCT01343095|BG002|Baseline|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
11057544|NCT01343095|BG003|Baseline|Total|Total of all reporting groups
11057545|NCT01343095|FG000|Participant Flow|Usual Care|Usual Care between 10pm-6am
11057546|NCT01343095|FG001|Participant Flow|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
11057547|NCT01343095|FG002|Participant Flow|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
11057548|NCT01343095|OG000|Outcome|Usual Care|Usual Care between 10pm-6am
11057549|NCT01343095|OG001|Outcome|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
11057550|NCT01343095|OG002|Outcome|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
11057551|NCT01343095|OG001|Outcome|Earplugs|"Application of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
11057552|NCT01343095|OG002|Outcome|Earplugs and Headphones|"Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
11057553|NCT01343095|EG000|Reported Event|Usual Care|Usual Care between 10pm-6am
11057554|NCT01343095|EG001|Reported Event|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
11057555|NCT01343095|EG002|Reported Event|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
11057556|NCT01343160|BG000|Baseline|GORE VIABIL|GORE® VIABIL® Biliary Endoprosthesis
11057557|NCT01343160|FG000|Participant Flow|GORE VIABIL® Biliary Endoprosthesis|"Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency~GORE® VIABIL® Biliary Endoprosthesis: Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture"
11057558|NCT01343160|OG000|Outcome|GORE VIABIL|GORE® VIABIL® Biliary Endoprosthesis
11057559|NCT01343160|OG000|Outcome|GORE VIABIL® Biliary Endoprosthesis|"Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency~GORE® VIABIL® Biliary Endoprosthesis: Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture"
11057560|NCT01343160|EG000|Reported Event|GORE VIABIL|GORE® VIABIL® Biliary Endoprosthesis
11057561|NCT01343251|BG000|Baseline|HeRO Graft|patients who are evaluated and receive a HeRO graft implant for hemodialysis
11057562|NCT01343251|BG001|Baseline|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
11057563|NCT01343251|BG002|Baseline|Total|Total of all reporting groups
11057564|NCT01343251|FG000|Participant Flow|HeRO Graft|patients who are evaluated and receive a Hemodialysis Reliable Outflow (HeRO) graft implant for hemodialysis
11057565|NCT01343251|FG001|Participant Flow|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
11057566|NCT01343251|OG000|Outcome|HeRO Graft|HeRO Graft Recipients
11057567|NCT01343251|OG001|Outcome|Control|HeRO eligible patients who did not receive HeRO
11057568|NCT01343251|OG000|Outcome|HeRO Graft|HeRO Graft recipients
11057569|NCT01343251|OG001|Outcome|Control|HeRO eligible patients who did not receive a HeRO
11057570|NCT01343251|OG001|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
11057571|NCT01343251|EG000|Reported Event|HeRO Graft|HeRO Graft recipients
11057572|NCT01343251|EG001|Reported Event|Control|HeRO eligible patients who did not receive a HeRO Graft
11057573|NCT01343277|BG000|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
11057574|NCT01343277|BG001|Baseline|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
11057575|NCT01343277|BG002|Baseline|Total|Total of all reporting groups
11057576|NCT01343277|FG000|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
11057577|NCT01343277|FG001|Participant Flow|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
11057578|NCT01343277|OG000|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
11057579|NCT01343277|OG001|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
11057580|NCT01343277|EG000|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
11057581|NCT01343277|EG001|Reported Event|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
11057582|NCT01343368|BG000|Baseline|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
11057583|NCT01343368|BG001|Baseline|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
11057584|NCT01343368|BG002|Baseline|Total|Total of all reporting groups
11057585|NCT01343368|FG000|Participant Flow|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
11057586|NCT01343368|FG001|Participant Flow|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
11066805|NCT01393990|FG005|Participant Flow|Part A: 120 mg LY2228820 Capsules|120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11057587|NCT01343368|OG000|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
11057588|NCT01343368|OG001|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
11057589|NCT01343368|EG000|Reported Event|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
11057590|NCT01343368|EG001|Reported Event|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
11057591|NCT01343407|BG000|Baseline|Randomized Participants|Crossover treatment with MK-1029 60 mg, MK-1029 500 mg, and matching placebo
11057592|NCT01343407|FG000|Participant Flow|Sequence 1|Placebo→MK-1029 60 mg→ MK-1029 500 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
11057593|NCT01343407|FG001|Participant Flow|Sequence 2|MK-1029 60 mg→MK-1029 500 mg→Placebo. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
11057594|NCT01343407|FG002|Participant Flow|Sequence 3|MK-1029 500 mg→Placebo→ MK-1029 60 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
11057595|NCT01343407|FG003|Participant Flow|Sequence 4|Placebo→MK-1029 500 mg→ MK-1029 60 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
11057596|NCT01343407|FG004|Participant Flow|Sequence 5|MK-1029 500 mg→MK-1029 60 mg→Placebo. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
11057597|NCT01343407|FG005|Participant Flow|Sequence 6|MK-1029 60 mg→Placebo→ MK-1029 500 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
11057598|NCT01343407|OG000|Outcome|MK-1029 60 mg|Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
11057599|NCT01343407|OG001|Outcome|MK-1029 500 mg|Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
11057600|NCT01343407|OG002|Outcome|Placebo|Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
11057601|NCT01343407|EG000|Reported Event|60 mg MK-1029|Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
11057602|NCT01343407|EG001|Reported Event|500 mg MK-1029|Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
11057603|NCT01343407|EG002|Reported Event|Placebo|Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
11057604|NCT01343485|BG000|Baseline|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
11057605|NCT01343485|BG001|Baseline|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
11057606|NCT01343485|BG002|Baseline|Total|Total of all reporting groups
11057607|NCT01343485|FG000|Participant Flow|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
11057608|NCT01343485|FG001|Participant Flow|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
11057609|NCT01343485|OG000|Outcome|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
11057610|NCT01343485|OG001|Outcome|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
11057611|NCT01343485|EG000|Reported Event|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
11057612|NCT01343485|EG001|Reported Event|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
11057613|NCT01343667|BG000|Baseline|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
11057614|NCT01343667|BG001|Baseline|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
11057615|NCT01343667|BG002|Baseline|Total|Total of all reporting groups
11057616|NCT01343667|FG000|Participant Flow|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
11057617|NCT01343667|FG001|Participant Flow|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
11057618|NCT01343667|OG000|Outcome|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System embolic protection device~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
11057619|NCT01343667|OG001|Outcome|GEF EPD|"Carotid artery stenting with Gore Embolic Filter embolic protection device~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
11057620|NCT01343667|EG000|Reported Event|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
11057621|NCT01343667|EG001|Reported Event|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
11057622|NCT01343693|BG000|Baseline|ACDF With MaxAn Plate|Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
11057623|NCT01343693|FG000|Participant Flow|ACDF With MaxAn Plate|Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
11057624|NCT01343693|OG000|Outcome|ACDF With MaxAn Plate|Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
11057625|NCT01343693|EG000|Reported Event|ACDF With MaxAn Plate|Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
11066806|NCT01393990|FG006|Participant Flow|Part A: 160 mg LY2228820 Capsules|160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066807|NCT01393990|FG007|Participant Flow|Part A: 200 mg LY2228820 Capsules|200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066808|NCT01393990|FG008|Participant Flow|Part A: 160 mg Bridge LY2228820|In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
11066809|NCT01393990|FG009|Participant Flow|Part A: 160 mg LY2228820 Tablets|160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066810|NCT01393990|FG010|Participant Flow|Part A: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066811|NCT01393990|FG011|Participant Flow|Part A: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066812|NCT01393990|FG012|Participant Flow|Part A: 420 mg LY2228820 Tablets|420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066813|NCT01393990|FG013|Participant Flow|Part A: 560 mg LY2228820 Tablets|560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066814|NCT01393990|FG014|Participant Flow|Part B: 420 mg LY2228820 Tablets|420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
11057626|NCT01343823|BG000|Baseline|Ecallantide 10 mg|
11057627|NCT01343823|BG001|Baseline|Ecallantide 30 mg|
11057628|NCT01343823|BG002|Baseline|Ecallantide 60 mg|
11057629|NCT01343823|BG003|Baseline|Placebo|
11057630|NCT01343823|BG004|Baseline|Total|Total of all reporting groups
11057631|NCT01343823|FG000|Participant Flow|Placebo|Administered by two subcutaneous injections.
11057632|NCT01343823|FG001|Participant Flow|Ecallantide 10 mg|10 mg administered as one 10 mg SC injection of ecallantide and one matching placebo
11057633|NCT01343823|FG002|Participant Flow|Ecallantide 30 mg|30 mg administered as one 30 mg SC injection of ecallantide and one matching placebo
11057634|NCT01343823|FG003|Participant Flow|Ecallantide 60mg|60 mg administered as two 30 mg SC injections of ecallantide
11057635|NCT01343823|OG000|Outcome|Placebo|
11057636|NCT01343823|OG001|Outcome|Ecallantide 10 mg|
11057637|NCT01343823|OG002|Outcome|Ecallantide 30 mg|
11057638|NCT01343823|OG003|Outcome|Ecallantide 60 mg|
11057639|NCT01343823|EG000|Reported Event|Ecallantide 10 mg|
11057640|NCT01343823|EG001|Reported Event|Ecallantide 30 mg|
11057641|NCT01343823|EG002|Reported Event|Ecallantide 60 mg|
11057642|NCT01343823|EG003|Reported Event|Placebo|
11057643|NCT01343888|BG000|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
11057644|NCT01343888|BG001|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
11057645|NCT01343888|BG002|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
11057646|NCT01343888|BG003|Baseline|Total|Total of all reporting groups
11057647|NCT01343888|FG000|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48.
11057648|NCT01343888|FG001|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48.
11057649|NCT01343888|FG002|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
11057650|NCT01343888|OG000|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
11057651|NCT01343888|OG001|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
11057652|NCT01343888|OG002|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
11057653|NCT01343888|EG000|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
11057654|NCT01343888|EG001|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
11057655|NCT01343888|EG002|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
11057656|NCT01343901|BG000|Baseline|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
11057657|NCT01343901|FG000|Participant Flow|Bevacizumab|All participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases for whom bevacizumab (Avastin) was administered as part of first line treatment for potentially resectable liver metastases as per treating physician discretion. All concomitant medications as used in daily routine clinical practice were allowed.
11057658|NCT01343901|OG000|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
11057659|NCT01343901|EG000|Reported Event|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
11057660|NCT01344057|BG000|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
11057661|NCT01344057|FG000|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
11057662|NCT01344057|OG000|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
11057663|NCT01344057|EG000|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of trivalent subunit inactivated adjuvanted influenza vaccine FLUAD during the vaccination visit, according to the study protocol (follow-up period: until day 22).
11057664|NCT01344161|BG000|Baseline|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
11057665|NCT01344161|BG001|Baseline|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
11057666|NCT01344161|BG002|Baseline|Total|Total of all reporting groups
11057667|NCT01344161|FG000|Participant Flow|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
11057668|NCT01344161|FG001|Participant Flow|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
11057669|NCT01344161|OG000|Outcome|Vitamin D|25 microgram cholecalciferol
11057670|NCT01344161|OG001|Outcome|Placebo|25 microgram lactose
11057671|NCT01344161|EG000|Reported Event|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
11057672|NCT01344161|EG001|Reported Event|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
11057673|NCT01344226|BG000|Baseline|Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati|patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
11057674|NCT01344226|FG000|Participant Flow|Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati|Subjects instilled one drop of topical loteprednol 0.5% suspension qid into the operative eye four times daily for a maximum of 22 days. Dosing began on the day of surgery and continued for 21 days postoperatively.
11057675|NCT01344226|OG000|Outcome|Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati|patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
11057676|NCT01344226|EG000|Reported Event|Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati|patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
11057677|NCT01344356|BG000|Baseline|Benign Tumors|"Benign head and neck tumors will be treated with SBRT~stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)"
11057678|NCT01344356|BG001|Baseline|Unrescectable Malignant Tumors|"Malignant Head and Neck Tumors will be treated with SBRT.~Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)"
11057679|NCT01344356|BG002|Baseline|Total|Total of all reporting groups
11057680|NCT01344356|FG000|Participant Flow|Benign Tumors|"Benign head and neck tumors will be treated with stereotactic body radiation therapy~stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)"
11057681|NCT01344356|FG001|Participant Flow|Unrescectable Malignant Tumors|"Malignant Head and Neck Tumors will be treated with stereotactic body radiation therapy.~Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)"
11057682|NCT01344356|OG000|Outcome|Benign Tumors|"Benign head and neck tumors will be treated with SBRT~stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)"
11057683|NCT01344356|OG001|Outcome|Malignant Tumors|"Malignant Head and Neck Tumors will be treated with SBRT.~Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)"
11057684|NCT01344356|OG000|Outcome|Benign Tumors|"Benign head and neck tumors will be treated with Stereotactic body radiotherapy~stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)"
11057685|NCT01344356|OG001|Outcome|Unrescectable Malignant Tumors|"Malignant Head and Neck Tumors will be treated with Stereotactic body radiotherapy.~Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)"
11057686|NCT01344356|EG000|Reported Event|Benign Tumors|"Benign head and neck tumors will be treated with SBRT~stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)"
11057687|NCT01344356|EG001|Reported Event|Malignant Tumors|"Malignant Head and Neck Tumors will be treated with SBRT.~Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)"
11057688|NCT01344369|BG000|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
11057689|NCT01344369|BG001|Baseline|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
11057690|NCT01344369|BG002|Baseline|Total|Total of all reporting groups
11057691|NCT01344369|FG000|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
11057692|NCT01344369|FG001|Participant Flow|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
11057693|NCT01344369|OG000|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
11057694|NCT01344369|OG001|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
11057695|NCT01344369|EG000|Reported Event|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
11057696|NCT01344369|EG001|Reported Event|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
11066815|NCT01393990|FG015|Participant Flow|Part C: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
11057697|NCT01344447|BG000|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
11057698|NCT01344447|FG000|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
11057699|NCT01344447|OG000|Outcome|Gadobutrol-enhanced MRA|
11057700|NCT01344447|OG001|Outcome|Unenhanced MRA|
11057701|NCT01344447|OG001|Outcome|Non-contrast MRA|
11057702|NCT01344447|OG000|Outcome|Gadobutrol-Enhanced MRA|
11057703|NCT01344447|OG002|Outcome|Computed Tomographic Angiography|
11057704|NCT01344447|EG000|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
11057705|NCT01344460|BG000|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
11057706|NCT01344460|FG000|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
11057707|NCT01344460|OG000|Outcome|Gadobutrol-enhanced MRA|
11057708|NCT01344460|OG001|Outcome|Unenhanced MRA|
11057709|NCT01344460|OG000|Outcome|Computed Tomographic Angiography (CTA)|
10887350|NCT00499915|OG000|Outcome|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
11057710|NCT01344460|OG000|Outcome|Gadobutrol-Enhanced MRA|
11057711|NCT01344460|OG002|Outcome|Computed Tomographic Angiography|
11057712|NCT01344460|EG000|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
11057713|NCT01344538|BG000|Baseline|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
11057714|NCT01344538|BG001|Baseline|Lactose Capsule|Placebo Capsule : 2.0 g per day
11057715|NCT01344538|BG002|Baseline|Total|Total of all reporting groups
11057716|NCT01344538|FG000|Participant Flow|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
11057717|NCT01344538|FG001|Participant Flow|Lactose Capsule|Placebo Capsule : 2.0 g per day
11057718|NCT01344538|OG000|Outcome|Lactose Capsule|Placebo Capsule : 2.0 g per day
11057719|NCT01344538|OG001|Outcome|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
11057720|NCT01344538|EG000|Reported Event|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations): 2.0 g per day (10:1 extract)
11057721|NCT01344538|EG001|Reported Event|Lactose Capsule|Placebo Capsule: 2.0 g per day
11057722|NCT01344616|BG000|Baseline|Usual Clinical Care|usual clinical care with no intervention
11057723|NCT01344616|BG001|Baseline|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
11057724|NCT01344616|BG002|Baseline|Total|Total of all reporting groups
11057725|NCT01344616|FG000|Participant Flow|Usual Clinical Care|usual clinical care with no intervention
11057726|NCT01344616|FG001|Participant Flow|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
11057727|NCT01344616|OG000|Outcome|Usual Clinical Care|usual clinical care with no intervention
11057728|NCT01344616|OG001|Outcome|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
11057729|NCT01344616|EG000|Reported Event|Usual Clinical Care|usual clinical care with no intervention
11057730|NCT01344616|EG001|Reported Event|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
11057731|NCT01344629|BG000|Baseline|Treatment Sequence A|
11057732|NCT01344629|BG001|Baseline|Treatment Sequence B|
11057733|NCT01344629|BG002|Baseline|Total|Total of all reporting groups
11057734|NCT01344629|FG000|Participant Flow|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
11057735|NCT01344629|FG001|Participant Flow|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
11057736|NCT01344629|OG000|Outcome|T80/A5 mg FDC Tablet|
11057737|NCT01344629|OG001|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
11057738|NCT01344629|EG000|Reported Event|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
11057739|NCT01344629|EG001|Reported Event|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
11057740|NCT01344759|BG000|Baseline|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
11057741|NCT01344759|BG001|Baseline|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
11057742|NCT01344759|BG002|Baseline|Total|Total of all reporting groups
11057743|NCT01344759|FG000|Participant Flow|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
11057744|NCT01344759|FG001|Participant Flow|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
11057745|NCT01344759|OG000|Outcome|Propofol|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump (Low dose). Baseline airway images are obtained during this time.~If a subject moves during baseline images a bolus of Propofol 0.5 mcg/kg will be given over 10 seconds and infusion rate will be increased to 120 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.~After the initial set of airway images are obtained, a bolus dose of propofol 2 mcg/kg will be given over 2 minutes followed by an increase in the infusion rate to 200 mcg/kg/hr (high dose)."
11057746|NCT01344759|OG001|Outcome|Dexmedetomidine|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump (low dose). Baseline airway images are obtained during this time.~If a subject moves during baseline images a bolus of DEX 0.5 mcg/kg will be given over 3 minutes and infusion rate will be increased to 1.5 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.~After the initial set of airway images are obtained, a 2 mcg/kg bolus of DEX will be given over 10 minutes followed by an increase in the infusion rate to 3 mcg/kg/hr (high dose)."
11057747|NCT01344759|OG000|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
11057748|NCT01344759|OG001|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
11057749|NCT01344759|OG002|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
11057750|NCT01344759|OG003|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
11057751|NCT01344759|OG004|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
11057752|NCT01344759|OG005|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
11057753|NCT01344759|EG000|Reported Event|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
11057754|NCT01344759|EG001|Reported Event|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
11057755|NCT01344824|BG000|Baseline|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
11057756|NCT01344824|FG000|Participant Flow|Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
11057757|NCT01344824|OG000|Outcome|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
11057758|NCT01344824|OG000|Outcome|Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
11057759|NCT01344824|EG000|Reported Event|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
11057760|NCT01344876|BG000|Baseline|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
11057761|NCT01344876|FG000|Participant Flow|OPB-51602: 1mg/Day|OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057762|NCT01344876|FG001|Participant Flow|OPB-51602: 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057763|NCT01344876|FG002|Participant Flow|OPB-51602: 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057764|NCT01344876|FG003|Participant Flow|OPB-51602: 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057765|NCT01344876|FG004|Participant Flow|OPB-51602: 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057766|NCT01344876|OG000|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
11057767|NCT01344876|OG000|Outcome|OPB-51602 1m/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057768|NCT01344876|OG001|Outcome|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057769|NCT01344876|OG002|Outcome|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057770|NCT01344876|OG003|Outcome|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057771|NCT01344876|OG004|Outcome|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057772|NCT01344876|EG000|Reported Event|OPB-51602 1mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057773|NCT01344876|EG001|Reported Event|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057774|NCT01344876|EG002|Reported Event|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057775|NCT01344876|EG003|Reported Event|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057776|NCT01344876|EG004|Reported Event|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
11057777|NCT01345019|BG000|Baseline|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.
11057778|NCT01345019|BG001|Baseline|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
11057779|NCT01345019|BG002|Baseline|Total|Total of all reporting groups
11057780|NCT01345019|FG000|Participant Flow|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.
11057781|NCT01345019|FG001|Participant Flow|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.
11057782|NCT01345019|OG000|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.
11057783|NCT01345019|OG001|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
11057784|NCT01345019|EG000|Reported Event|DB: Zoledronic Acid|Participants received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
11057785|NCT01345019|EG001|Reported Event|DB: Denosumab|Participants received denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
11057786|NCT01345019|EG002|Reported Event|OL: Zoledronic Acid / Denosumab|Participants who received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.
11057787|NCT01345019|EG003|Reported Event|OL: Denosumab / Denosumab|Participants who received denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.
11057788|NCT01345058|BG000|Baseline|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
11057789|NCT01345058|BG001|Baseline|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
11057790|NCT01345058|BG002|Baseline|Total|Total of all reporting groups
11057791|NCT01345058|FG000|Participant Flow|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
11057792|NCT01345058|FG001|Participant Flow|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
11057793|NCT01345058|OG000|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
11057794|NCT01345058|OG001|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
11057795|NCT01345058|EG000|Reported Event|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
11057796|NCT01345058|EG001|Reported Event|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
11057797|NCT01345123|BG000|Baseline|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
11057798|NCT01345123|BG001|Baseline|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
11057799|NCT01345123|BG002|Baseline|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
11057800|NCT01345123|BG003|Baseline|Total|Total of all reporting groups
11057801|NCT01345123|FG000|Participant Flow|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
11057802|NCT01345123|FG001|Participant Flow|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
11057803|NCT01345123|FG002|Participant Flow|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
11057804|NCT01345123|OG000|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
11057805|NCT01345123|OG001|Outcome|Decision Aid Only|Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
11057806|NCT01345123|OG002|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
11057807|NCT01345123|OG001|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
11057808|NCT01345123|EG000|Reported Event|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
11057809|NCT01345123|EG001|Reported Event|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
11057810|NCT01345123|EG002|Reported Event|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
11057811|NCT01345162|BG000|Baseline|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
11057812|NCT01345162|BG001|Baseline|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
11057813|NCT01345162|BG002|Baseline|Total|Total of all reporting groups
11057814|NCT01345162|FG000|Participant Flow|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
11057815|NCT01345162|FG001|Participant Flow|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
11057816|NCT01345162|OG000|Outcome|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
11057817|NCT01345162|OG001|Outcome|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
11057818|NCT01345162|EG000|Reported Event|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
11057819|NCT01345162|EG001|Reported Event|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
11057820|NCT01345188|BG000|Baseline|Entire Study Population|Includes both groups randomized to placebo and ranolazine
11057821|NCT01345188|FG000|Participant Flow|Ranolazine, Then Placebo|Patient received Ranolazine to 1,000 mg ranolazine orally twice a day, as tolerated for 6 weeks. After a washout period of 2 weeks, they then received Placebo tablet (matching Ranolazine 1000 mg tablet twice a week) for 6 weeks.
11057822|NCT01345188|OG000|Outcome|Ranolazine|
11057823|NCT01345188|OG001|Outcome|Placebo|Patients that received placebo
11057824|NCT01345188|OG000|Outcome|Ranolazine|Patients that received ranolazine
11057825|NCT01345188|EG000|Reported Event|Ranolazine|patients receiving ranolazine
11057826|NCT01345188|EG001|Reported Event|Placebo|Patients receiving placebo
11057827|NCT01345253|BG000|Baseline|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
11057828|NCT01345253|BG001|Baseline|Belimumab 10 mg/kg|Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
11057829|NCT01345253|BG002|Baseline|Total|Total of all reporting groups
11057830|NCT01345253|FG000|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
11057831|NCT01345253|FG001|Participant Flow|Belimumab 10 mg/kg|Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
11057832|NCT01345253|OG000|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
11057833|NCT01345253|OG001|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
11057834|NCT01345253|OG000|Outcome|Belimumab 10mg/kg (Open-label Phase)|All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.
11057835|NCT01345253|EG000|Reported Event|Placebo (Double-blind Phase)|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
11057836|NCT01345253|EG001|Reported Event|Belimumab 10 mg/kg (Double-blind Phase)|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
11057837|NCT01345253|EG002|Reported Event|Belimumab 10 mg/kg (Open-label Phase)|All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.
11057838|NCT01345292|BG000|Baseline|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
11057839|NCT01345292|BG001|Baseline|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
11057840|NCT01345292|BG002|Baseline|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
11057841|NCT01345292|BG003|Baseline|Total|Total of all reporting groups
11057842|NCT01345292|FG000|Participant Flow|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
11057843|NCT01345292|FG001|Participant Flow|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
11057844|NCT01345292|FG002|Participant Flow|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
11057845|NCT01345292|OG000|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
11057846|NCT01345292|OG001|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
11057847|NCT01345292|OG002|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
11057848|NCT01345292|EG000|Reported Event|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
11057849|NCT01345292|EG001|Reported Event|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
11057850|NCT01345292|EG002|Reported Event|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
11057851|NCT01345318|BG000|Baseline|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
11057852|NCT01345318|FG000|Participant Flow|PF-04236921|All participants entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
11057853|NCT01345318|OG000|Outcome|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
11057854|NCT01345318|OG000|Outcome|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
11057855|NCT01345318|EG000|Reported Event|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
11057856|NCT01345513|BG000|Baseline|Solid Tumor Cancer|Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
11057857|NCT01345513|FG000|Participant Flow|Solid Tumor Cancer|Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
11057858|NCT01345513|OG000|Outcome|Solid Tumor Cancer|Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
11057859|NCT01345513|EG000|Reported Event|Solid Tumor Cancer|Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
11057860|NCT01345591|BG000|Baseline|Fat Grafting|Fat Grafting for facial trauma
11057861|NCT01345591|FG000|Participant Flow|Fat Grafting|fat grafting for facial trauma
11057862|NCT01345591|OG000|Outcome|Fat Graft Volume at 3 Months|fat grafting for facial trauma, volume measured at 3 months post-op
11057863|NCT01345591|OG001|Outcome|Fat Graft Volume at 9 Months|fat grafting for facial trauma, volume measured at 9 months post-op
11057864|NCT01345591|OG000|Outcome|Fat Grafting_evaluation at Baseline|quality of life measurement at baseline to include SWAP, COPE and CSQ-8 questionnaires
11057865|NCT01345591|OG001|Outcome|Fat Grafting_7-21 Days Post op|quality of life measurement at 7-21 days post-op to include SWAP, COPE and CSQ-8 questionnaires
11057866|NCT01345591|OG002|Outcome|Fat Grafting_3 Months Post op|quality of life measurement at 3 months post-op to include SWAP, COPE and CSQ-8 questionnaires
11226708|NCT02377427|OG002|Outcome|Part B: Mepolizumab 40/100 mg SC|Participants received either 0.4 mL or 1.0 mL of reconstituted mepolizumab depending upon the bodyweight, administered subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. Participants enrolled to <40 kg at Visit 9 (Week 20) were summarized in the 40/100 mg SC group if they had weight >=40 kg at any subsequent visit.
11226709|NCT02377427|EG000|Reported Event|Part A: Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
11226710|NCT02377427|EG001|Reported Event|Part A: Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
11057867|NCT01345591|OG003|Outcome|Fat Grafting_9 Months Post-op|quality of life measurement at 9 months post-op to include SWAP, COPE and CSQ-8 questionnaires
11057868|NCT01345591|EG000|Reported Event|Fat Grafting|fat grafting for facial trauma
11057869|NCT01345630|BG000|Baseline|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
11057870|NCT01345630|BG001|Baseline|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
11057871|NCT01345630|BG002|Baseline|Total|Total of all reporting groups
11057872|NCT01345630|FG000|Participant Flow|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
11057873|NCT01345630|FG001|Participant Flow|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
11057874|NCT01345630|OG000|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
11057875|NCT01345630|OG001|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
11057876|NCT01345630|OG000|Outcome|MVC+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results by baseline.
11057877|NCT01345630|OG001|Outcome|MVC+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
11057878|NCT01345630|OG002|Outcome|FTC/TDF+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results by baseline.
10847096|NCT00281671|OG000|Outcome|Placebo|"In this crossover pilot study, patients are randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.~nesiritide: nesiritide 0.015 mcg/kg/hour x 10 hours"
11057879|NCT01345630|OG003|Outcome|FTC/TDF+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
11057880|NCT01345630|EG000|Reported Event|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
11057881|NCT01345630|EG001|Reported Event|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
11057882|NCT01345669|BG000|Baseline|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
11057883|NCT01345669|BG001|Baseline|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
11057884|NCT01345669|BG002|Baseline|Total|Total of all reporting groups
11057885|NCT01345669|FG000|Participant Flow|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
11057886|NCT01345669|FG001|Participant Flow|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
11057887|NCT01345669|OG000|Outcome|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
11057888|NCT01345669|OG001|Outcome|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
11057889|NCT01345669|EG000|Reported Event|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
11057890|NCT01345669|EG001|Reported Event|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
11057891|NCT01345682|BG000|Baseline|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
11057892|NCT01345682|BG001|Baseline|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
11057893|NCT01345682|BG002|Baseline|Total|Total of all reporting groups
11057894|NCT01345682|FG000|Participant Flow|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
11057895|NCT01345682|FG001|Participant Flow|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
11057896|NCT01345682|OG000|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
11057897|NCT01345682|OG001|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
11057898|NCT01345682|EG000|Reported Event|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
11057899|NCT01345682|EG001|Reported Event|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 milligram per square meter mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
11057900|NCT01345721|BG000|Baseline|MenACWY (2 Primary +1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
11057901|NCT01345721|BG001|Baseline|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
11057902|NCT01345721|BG002|Baseline|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
11057903|NCT01345721|BG003|Baseline|Total|Total of all reporting groups
11057904|NCT01345721|FG000|Participant Flow|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
11057905|NCT01345721|FG001|Participant Flow|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
11057906|NCT01345721|FG002|Participant Flow|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
11057907|NCT01345721|OG000|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
11057908|NCT01345721|OG001|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
11057909|NCT01345721|OG002|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
11057910|NCT01345721|OG002|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
11057911|NCT01345721|OG000|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
11057912|NCT01345721|OG000|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
11057913|NCT01345721|OG001|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
11057914|NCT01345721|EG000|Reported Event|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
11057915|NCT01345721|EG001|Reported Event|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
11057916|NCT01345721|EG002|Reported Event|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
11057917|NCT01345929|BG000|Baseline|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
11057918|NCT01345929|BG001|Baseline|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
11057919|NCT01345929|BG002|Baseline|Total|Total of all reporting groups
11057920|NCT01345929|FG000|Participant Flow|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days~Of the 1083 subjects in the integrated analysis set, 533 received CXA."
11057921|NCT01345929|FG001|Participant Flow|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days~Of the 1083 subjects in the integrated analysis set, 535 received levofloxacin."
11057922|NCT01345929|OG000|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
11057923|NCT01345929|OG001|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
11057924|NCT01345929|EG000|Reported Event|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
11057925|NCT01345929|EG001|Reported Event|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
11057926|NCT01346059|BG000|Baseline|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
11057927|NCT01346059|BG001|Baseline|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
11057928|NCT01346059|BG002|Baseline|Total|Total of all reporting groups
11057929|NCT01346059|FG000|Participant Flow|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
11057930|NCT01346059|FG001|Participant Flow|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
11057931|NCT01346059|OG000|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
11057932|NCT01346059|OG001|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
11057933|NCT01346059|EG000|Reported Event|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
11057934|NCT01346059|EG001|Reported Event|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
11057935|NCT01346072|BG000|Baseline|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
11057936|NCT01346072|BG001|Baseline|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
11057937|NCT01346072|BG002|Baseline|Total|Total of all reporting groups
11057938|NCT01346072|FG000|Participant Flow|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
11057939|NCT01346072|FG001|Participant Flow|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
11057940|NCT01346072|OG000|Outcome|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
11057941|NCT01346072|OG001|Outcome|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
11057942|NCT01346072|EG000|Reported Event|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
11057943|NCT01346072|EG001|Reported Event|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
11057944|NCT01346085|BG000|Baseline|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
11057945|NCT01346085|FG000|Participant Flow|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
11057946|NCT01346085|OG000|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
11057947|NCT01346085|EG000|Reported Event|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
11057948|NCT01346176|BG000|Baseline|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
11057949|NCT01346176|BG001|Baseline|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
11057950|NCT01346176|BG002|Baseline|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
11057951|NCT01346176|BG003|Baseline|Total|Total of all reporting groups
11057952|NCT01346176|FG000|Participant Flow|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
11057953|NCT01346176|FG001|Participant Flow|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
11057954|NCT01346176|FG002|Participant Flow|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
11057955|NCT01346176|OG000|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
11057956|NCT01346176|OG001|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
11057957|NCT01346176|OG002|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
11057958|NCT01346176|EG000|Reported Event|Forced Choice|
11057959|NCT01346176|EG001|Reported Event|Negative Default|
11057960|NCT01346176|EG002|Reported Event|Positive Default|
11057961|NCT01346189|BG000|Baseline|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057962|NCT01346189|BG001|Baseline|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057963|NCT01346189|BG002|Baseline|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057964|NCT01346189|BG003|Baseline|Usual Care|No Intervention
11057965|NCT01346189|BG004|Baseline|Total|Total of all reporting groups
11057966|NCT01346189|FG000|Participant Flow|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057967|NCT01346189|FG001|Participant Flow|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057968|NCT01346189|FG002|Participant Flow|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057969|NCT01346189|FG003|Participant Flow|Usual Care/Control|No Intervention
11057970|NCT01346189|OG000|Outcome|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057971|NCT01346189|OG001|Outcome|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057972|NCT01346189|OG002|Outcome|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057973|NCT01346189|OG003|Outcome|Usual Care|
11057974|NCT01346189|EG000|Reported Event|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057975|NCT01346189|EG001|Reported Event|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057976|NCT01346189|EG002|Reported Event|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
11057977|NCT01346189|EG003|Reported Event|Usual Care/Control|
11057978|NCT01346267|BG000|Baseline|Arm I- Real Acupressure Bands|"Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.~Real Acupressure Band: Acupressure wristband"
11057979|NCT01346267|BG001|Baseline|Arm II- Placebo Acupressure Bands|"Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.~Placebo Acupressure Band: Sham wristband"
11057980|NCT01346267|BG002|Baseline|Total|Total of all reporting groups
11057981|NCT01346267|FG000|Participant Flow|Arm I- Real Acupressure Bands|"Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.~Real Acupressure Band: Acupressure wristband"
11057982|NCT01346267|FG001|Participant Flow|Arm II- Placebo Acupressure Bands|"Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.~Placebo Acupressure Band: Sham wristband"
11057983|NCT01346267|OG000|Outcome|Arm I- Real Acupressure Bands|"Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.~Real Acupressure Band: Acupressure wristband"
11057984|NCT01346267|OG001|Outcome|Arm II- Placebo Acupressure Bands|"Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.~Placebo Acupressure Band: Sham wristband"
11057985|NCT01346267|EG000|Reported Event|Arm I- Real Acupressure Bands|"Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.~Real Acupressure Band: Acupressure wristband"
11057986|NCT01346267|EG001|Reported Event|Arm II- Placebo Acupressure Bands|"Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.~Placebo Acupressure Band: Sham wristband"
11057987|NCT01346293|BG000|Baseline|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
11057988|NCT01346293|BG001|Baseline|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
11057989|NCT01346293|BG002|Baseline|Total|Total of all reporting groups
11057990|NCT01346293|FG000|Participant Flow|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
11057991|NCT01346293|FG001|Participant Flow|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
11057992|NCT01346293|OG000|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
11057993|NCT01346293|OG001|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
11057994|NCT01346293|OG000|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
11057995|NCT01346293|OG001|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
11057996|NCT01346293|EG000|Reported Event|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
11057997|NCT01346293|EG001|Reported Event|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
11057998|NCT01346371|BG000|Baseline|Refresh Tears® Eye Drops|Must add drops twice a day every day during trial enrollment.
11057999|NCT01346371|BG001|Baseline|Bepreve® 1.5% Solution|Must add drops twice a day every day while enrolled in trial.
11058000|NCT01346371|BG002|Baseline|Total|Total of all reporting groups
11058001|NCT01346371|FG000|Participant Flow|Refresh Tears® Eye Drops|Must add drops twice a day every day during trial enrollment.
11058002|NCT01346371|FG001|Participant Flow|Bepreve® 1.5% Solution|Must add drops twice a day every day while enrolled in trial.
11058003|NCT01346371|OG000|Outcome|Refresh Tears® Eye Drops|Must add drops twice a day every day during trial enrollment.
11058004|NCT01346371|OG001|Outcome|Bepreve® 1.5% Solution|Must add drops twice a day every day while enrolled in trial.
11058005|NCT01346371|EG000|Reported Event|Refresh Tears® Eye Drops|Must add drops twice a day every day during trial enrollment.
11058006|NCT01346371|EG001|Reported Event|Bepreve® 1.5% Solution|Must add drops twice a day every day while enrolled in trial.
11058007|NCT01346397|BG000|Baseline|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
11058008|NCT01346397|BG001|Baseline|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
11058009|NCT01346397|BG002|Baseline|Total|Total of all reporting groups
11058010|NCT01346397|FG000|Participant Flow|Cyclosporine Group|cyclosporine group - after Campath induction cyclosporine will be administered
11058011|NCT01346397|FG001|Participant Flow|Tacrolimus Group|tacrolimus group - after Campath induction tacrolimus will be administered
11058012|NCT01346397|OG000|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
11058013|NCT01346397|OG001|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
11058014|NCT01346397|EG000|Reported Event|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
11058015|NCT01346397|EG001|Reported Event|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
11058016|NCT01346410|BG000|Baseline|Stereotactic Radiation to Pancreas|"Stereotactic Radiation to Pancreas~Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)"
11058017|NCT01346410|FG000|Participant Flow|Stereotactic Radiation to Pancreas|"Stereotactic Radiation to Pancreas~Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)"
11058018|NCT01346410|OG000|Outcome|Stereotactic Radiation to Pancreas|"Stereotactic Radiation to Pancreas~Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)"
11058019|NCT01346410|EG000|Reported Event|Stereotactic Radiation to Pancreas|"Stereotactic Radiation to Pancreas~Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)"
11058020|NCT01346475|BG000|Baseline|Valacyclovir|
11058021|NCT01346475|BG001|Baseline|High Dose Valacyclovir|
11058022|NCT01346475|BG002|Baseline|Total|Total of all reporting groups
11058023|NCT01346475|FG000|Participant Flow|Standard-dose Valacyclovir First Then High-dose Valacyclovir|Standard-dose valacyclovir (500 mg daily) for 5 weeks followed by 1 week wash-out and then high-dose valacyclovir (1 gram three times daily) for 5 weeks
11058024|NCT01346475|FG001|Participant Flow|High-dose Valacyclovir First Then Standard-dose Valacyclovir|High-dose valacyclovir (1 gram three times daily) for 5 weeks followed by 1 week wash-out and then standard-dose valacyclovir (500 mg daily) for 5 weeks
11058025|NCT01346475|OG000|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
11058026|NCT01346475|OG001|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
11058027|NCT01346475|EG000|Reported Event|Valacyclovir|
11058028|NCT01346475|EG001|Reported Event|High Dose Valacyclovir|
11058029|NCT01346488|BG000|Baseline|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
11058030|NCT01346488|FG000|Participant Flow|Participants Receiving Adalimumab|Participants with rheumatoid arthritis (RA) treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
11058031|NCT01346488|OG000|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
11058032|NCT01346488|EG000|Reported Event|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
11058033|NCT01346501|BG000|Baseline|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
10887280|NCT00499616|FG001|Participant Flow|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11058034|NCT01346501|BG001|Baseline|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
11058035|NCT01346501|BG002|Baseline|Total|Total of all reporting groups
11058036|NCT01346501|FG000|Participant Flow|Adalimumab|Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859 (HOPEFUL I study; NCT00870467), participated in the observational period of studies P12-069 (HOPEFUL II study; NCT01163292) and P12-707 (HOPEFUL III study; NCT01346501).
11058037|NCT01346501|FG001|Participant Flow|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
11058038|NCT01346501|OG000|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score <3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
11058039|NCT01346501|OG000|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
11058040|NCT01346501|OG001|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
11058041|NCT01346501|OG001|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707.
11058042|NCT01346501|EG000|Reported Event|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707
11058043|NCT01346501|EG001|Reported Event|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707
10887090|NCT00498615|OG002|Outcome|Placebo|"Time to reach 70% of skin temperature after cold challenge done 2 hrs after taking placebo~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
10887091|NCT00498615|EG000|Reported Event|Placebo|Placebo was administered 2 hours before a standardized cold challenge.
10887092|NCT00498615|EG001|Reported Event|40 mg Fasudil|40 mg Fasudil was administered 2 hours before a standardized cold challenge.
10887093|NCT00498615|EG002|Reported Event|80mg Fasudil|80mg Fasudil was administered 2 hours before a standardized cold challenge.
10887094|NCT00498628|BG000|Baseline|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
10887095|NCT00498628|BG001|Baseline|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
10887096|NCT00498628|BG002|Baseline|Total|Total of all reporting groups
10887097|NCT00498628|FG000|Participant Flow|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
10887098|NCT00498628|FG001|Participant Flow|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
10887099|NCT00498628|OG000|Outcome|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
10887100|NCT00498628|OG001|Outcome|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
10887101|NCT00498628|OG000|Outcome|Quetiapine|"Quetiapine fumarate plus medical management~Quetiapine fumarate: Quetiapine fumarate- taken daily, for 12 weeks"
10887102|NCT00498628|OG001|Outcome|Placebo|"Medical management plus placebo comparator~Placebo: Placebo"
10887103|NCT00498628|EG000|Reported Event|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
10887104|NCT00498628|EG001|Reported Event|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
10887105|NCT00498706|BG000|Baseline|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
10887106|NCT00498706|BG001|Baseline|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
10887107|NCT00498706|BG002|Baseline|Total|Total of all reporting groups
10887108|NCT00498706|FG000|Participant Flow|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
10887109|NCT00498706|FG001|Participant Flow|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
10887110|NCT00498706|OG000|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
10887111|NCT00498706|OG001|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
11058044|NCT01346514|BG000|Baseline|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
11058045|NCT01346514|BG001|Baseline|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
11058046|NCT01346514|BG002|Baseline|Total|Total of all reporting groups
11226711|NCT02377427|EG002|Reported Event|Part B: Mepolizumab 40 mg SC|Participants with bodyweight < 40 kg received 0.4 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
11058047|NCT01346514|FG000|Participant Flow|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
11058048|NCT01346514|FG001|Participant Flow|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
11058049|NCT01346514|OG000|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
11058050|NCT01346514|OG001|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
11058051|NCT01346514|OG000|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
11058052|NCT01346514|OG001|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
11058053|NCT01346514|EG000|Reported Event|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
11058054|NCT01346514|EG001|Reported Event|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
11058055|NCT01346540|BG000|Baseline|Nintedanib 150 Milligram|Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11058056|NCT01346540|BG001|Baseline|Nintedanib 200 Milligram|Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11058057|NCT01346540|BG002|Baseline|Total|Total of all reporting groups
11058058|NCT01346540|FG000|Participant Flow|Nintedanib 150 Milligram|Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11058059|NCT01346540|FG001|Participant Flow|Nintedanib 200 Milligram|Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11058060|NCT01346540|OG000|Outcome|Nintedanib 150 Milligram|Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11058061|NCT01346540|OG001|Outcome|Nintedanib 200 Milligram|Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11058062|NCT01346540|OG000|Outcome|Nintedanib 150/200 Milligram|Patient received 150 or 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11058063|NCT01346540|EG000|Reported Event|Nintedanib 150 Milligram|Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11066816|NCT01393990|FG016|Participant Flow|Part D: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11058064|NCT01346540|EG001|Reported Event|Nintedanib 200 Milligram|Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
11058065|NCT01346592|BG000|Baseline|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058066|NCT01346592|BG001|Baseline|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058067|NCT01346592|BG002|Baseline|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058068|NCT01346592|BG003|Baseline|Total|Total of all reporting groups
11058069|NCT01346592|FG000|Participant Flow|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058070|NCT01346592|FG001|Participant Flow|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11341971|NCT03694210|FG000|Participant Flow|EndoRotor Therapy|"Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.~EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis."
11058071|NCT01346592|FG002|Participant Flow|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058072|NCT01346592|OG000|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
11058073|NCT01346592|OG001|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
11058074|NCT01346592|OG002|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
11058075|NCT01346592|OG000|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058076|NCT01346592|OG001|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058077|NCT01346592|OG002|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058078|NCT01346592|OG000|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
11058079|NCT01346592|OG001|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
11058080|NCT01346592|OG000|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
11058081|NCT01346592|OG001|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
11058082|NCT01346592|OG002|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
11058083|NCT01346592|OG001|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
11058084|NCT01346592|OG003|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
11058085|NCT01346592|OG004|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
11058086|NCT01346592|OG005|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
11058087|NCT01346592|OG006|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
11058088|NCT01346592|OG007|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
11058089|NCT01346592|OG008|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
11058090|NCT01346592|OG001|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058091|NCT01346592|OG002|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058092|NCT01346592|EG000|Reported Event|ATIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058093|NCT01346592|EG001|Reported Event|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058094|NCT01346592|EG002|Reported Event|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
11058095|NCT01346683|BG000|Baseline|OsseoSpeed TX|OsseoSpeed TX implants of lengths 8-17 mm
11058096|NCT01346683|FG000|Participant Flow|OsseoSpeed TX|OsseoSpeed TX implants of lengths 8-17 mm
11058097|NCT01346683|OG000|Outcome|OsseoSpeed TX|OsseoSpeed TX implants of lengths 8-17 mm
11058098|NCT01346683|EG000|Reported Event|OsseoSpeed TX|OsseoSpeed TX implants of lengths 8-17 mm
11058099|NCT01346696|BG000|Baseline|OsseoSpeed™ TX Implants|OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
11058100|NCT01346696|FG000|Participant Flow|OsseoSpeed™ TX Implants|OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
11058101|NCT01346696|OG000|Outcome|OsseoSpeed™ TX Implants|OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
11058102|NCT01346696|EG000|Reported Event|OsseoSpeed™ TX Implants|OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
11058103|NCT01346774|BG000|Baseline|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
11058104|NCT01346774|BG001|Baseline|Placebo|Placebo powder: 2 placebo powder capsules twice a day
11058105|NCT01346774|BG002|Baseline|Total|Total of all reporting groups
11058106|NCT01346774|FG000|Participant Flow|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
11058107|NCT01346774|FG001|Participant Flow|Placebo|Placebo powder: 2 placebo powder capsules twice a day
11058108|NCT01346774|OG000|Outcome|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
11058109|NCT01346774|OG001|Outcome|Placebo|Placebo powder: 2 placebo powder capsules twice a day
11058110|NCT01346774|EG000|Reported Event|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
11058111|NCT01346774|EG001|Reported Event|Placebo Capsules|Placebo powder: 2 placebo powder capsules twice a day
11058112|NCT01346839|BG000|Baseline|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
11058113|NCT01346839|BG001|Baseline|Usual Care Control|"The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a View Alert window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS."
11058114|NCT01346839|BG002|Baseline|Total|Total of all reporting groups
11058115|NCT01346839|FG000|Participant Flow|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
11058116|NCT01346839|FG001|Participant Flow|Usual Care Control|"The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a View Alert window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS."
11066817|NCT01393990|FG017|Participant Flow|Part D: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11066818|NCT01393990|OG000|Outcome|Part A: 10 mg LY2228820 Capsules|10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11058117|NCT01346839|OG000|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
11058118|NCT01346839|OG001|Outcome|Usual Care Control|"The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a View Alert window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS."
11058119|NCT01346839|EG000|Reported Event|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
11058120|NCT01346839|EG001|Reported Event|Usual Care Control|"The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a View Alert window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS."
11058121|NCT01346852|BG000|Baseline|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058122|NCT01346852|BG001|Baseline|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058123|NCT01346852|BG002|Baseline|Total|Total of all reporting groups
11058124|NCT01346852|FG000|Participant Flow|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058125|NCT01346852|FG001|Participant Flow|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058126|NCT01346852|OG000|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058127|NCT01346852|OG001|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058128|NCT01346852|EG000|Reported Event|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058129|NCT01346852|EG001|Reported Event|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058130|NCT01346969|BG000|Baseline|EXC 001 (PF-06473871) 5 mg/cm|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
11058131|NCT01346969|BG001|Baseline|EXC 001 (PF-06473871) 2 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058132|NCT01346969|BG002|Baseline|EXC 001 (PF-06473871) 0.8 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058133|NCT01346969|BG003|Baseline|EXC 001 (PF-06473871) 5 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058134|NCT01346969|BG004|Baseline|Total|Total of all reporting groups
11058135|NCT01346969|FG000|Participant Flow|EXC 001 (PF-06473871) 5 mg/cm|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
11058136|NCT01346969|FG001|Participant Flow|EXC 001 (PF-06473871) 2 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058137|NCT01346969|FG002|Participant Flow|EXC 001 (PF-06473871) 0.8 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058138|NCT01346969|FG003|Participant Flow|EXC 001 (PF-06473871) 5 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058139|NCT01346969|OG000|Outcome|EXC 001 (PF-06473871) 5 mg/cm|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
11058140|NCT01346969|OG001|Outcome|EXC 001 (PF-06473871) 2 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11226712|NCT02377427|EG003|Reported Event|Part B: Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
11058141|NCT01346969|OG002|Outcome|EXC 001 (PF-06473871) 0.8 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058142|NCT01346969|OG003|Outcome|EXC 001 (PF-06473871) 5 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058143|NCT01346969|EG000|Reported Event|EXC 001 (PF-06473871) 5 mg/cm|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
11058144|NCT01346969|EG001|Reported Event|EXC 001 (PF-06473871) 2 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058145|NCT01346969|EG002|Reported Event|EXC 001 (PF-06473871) 0.8 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058146|NCT01346969|EG003|Reported Event|EXC 001 (PF-06473871) 5 mg/cm and Placebo|Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
11058147|NCT01347008|BG000|Baseline|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
11058148|NCT01347008|BG001|Baseline|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
11058149|NCT01347008|BG002|Baseline|Total|Total of all reporting groups
11058150|NCT01347008|FG000|Participant Flow|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
11058151|NCT01347008|FG001|Participant Flow|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
11058152|NCT01347008|OG000|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
11058153|NCT01347008|OG001|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
11058154|NCT01347008|EG000|Reported Event|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
11058155|NCT01347008|EG001|Reported Event|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
11058156|NCT01347034|BG000|Baseline|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
11058157|NCT01347034|BG001|Baseline|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
11058158|NCT01347034|BG002|Baseline|Total|Total of all reporting groups
11058159|NCT01347034|FG000|Participant Flow|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
11058160|NCT01347034|FG001|Participant Flow|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
11058161|NCT01347034|OG000|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
10849056|NCT00293423|OG000|Outcome|Phase 2: Vaccine|Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
11058162|NCT01347034|OG001|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
11058163|NCT01347034|EG000|Reported Event|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
11058164|NCT01347034|EG001|Reported Event|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
11058165|NCT01347060|BG000|Baseline|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
11058166|NCT01347060|BG001|Baseline|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058167|NCT01347060|BG002|Baseline|Total|Total of all reporting groups
11058168|NCT01347060|FG000|Participant Flow|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
11058169|NCT01347060|FG001|Participant Flow|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058170|NCT01347060|OG000|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
11058171|NCT01347060|OG001|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058172|NCT01347060|EG000|Reported Event|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
11058173|NCT01347060|EG001|Reported Event|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
11058174|NCT01347073|BG000|Baseline|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
11058175|NCT01347073|FG000|Participant Flow|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
11058176|NCT01347073|OG000|Outcome|NaPBA|Switch Over Arm
11058177|NCT01347073|OG001|Outcome|HPN-100|Switch Over and Long Term Treatment Arm
11058178|NCT01347073|OG000|Outcome|NaPBA|Switch Over
11058179|NCT01347073|OG001|Outcome|HPN-100|Switch Over and Long Term Treatment
11058180|NCT01347073|OG000|Outcome|Pre-enrollment|12-months preceding the study
11058181|NCT01347073|OG001|Outcome|Long-term Phase|The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
11058182|NCT01347073|OG000|Outcome|HPN-100|Long Term Treatment
11058183|NCT01347073|EG000|Reported Event|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
11058184|NCT01347086|BG000|Baseline|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058185|NCT01347086|BG001|Baseline|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058186|NCT01347086|BG002|Baseline|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
10849057|NCT00293423|EG000|Reported Event|Phase 1: Vaccine|Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
11058187|NCT01347086|BG003|Baseline|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058188|NCT01347086|BG004|Baseline|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058189|NCT01347086|BG005|Baseline|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058190|NCT01347086|BG006|Baseline|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058191|NCT01347086|BG007|Baseline|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058192|NCT01347086|BG008|Baseline|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058193|NCT01347086|BG009|Baseline|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058194|NCT01347086|BG010|Baseline|Total|Total of all reporting groups
11058195|NCT01347086|FG000|Participant Flow|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058196|NCT01347086|FG001|Participant Flow|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058197|NCT01347086|FG002|Participant Flow|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058198|NCT01347086|FG003|Participant Flow|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058199|NCT01347086|FG004|Participant Flow|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058200|NCT01347086|FG005|Participant Flow|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058201|NCT01347086|FG006|Participant Flow|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058202|NCT01347086|FG007|Participant Flow|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058203|NCT01347086|FG008|Participant Flow|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058204|NCT01347086|FG009|Participant Flow|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058205|NCT01347086|OG000|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058206|NCT01347086|OG001|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058207|NCT01347086|OG002|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058208|NCT01347086|OG003|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058209|NCT01347086|OG004|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058210|NCT01347086|OG005|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058211|NCT01347086|OG006|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058212|NCT01347086|OG007|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058213|NCT01347086|OG008|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058214|NCT01347086|OG009|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
11058215|NCT01347086|OG000|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058216|NCT01347086|OG001|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058217|NCT01347086|OG002|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058218|NCT01347086|OG003|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058219|NCT01347086|OG004|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058220|NCT01347086|OG005|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058221|NCT01347086|OG006|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058222|NCT01347086|OG001|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058223|NCT01347086|OG002|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058224|NCT01347086|OG003|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058225|NCT01347086|OG003|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058226|NCT01347086|OG004|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058227|NCT01347086|OG001|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058228|NCT01347086|OG002|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058229|NCT01347086|OG004|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058230|NCT01347086|OG005|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
11058231|NCT01347086|EG000|Reported Event|Placebo|All (Caucasian, Japanese and Chinese) subjects that received matching placebo. Oral with 240 mL of water in fed condition.
11058232|NCT01347086|EG001|Reported Event|400 mg Deleobuvir|All (Japanese and Chinese) subjects that received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition.
11058233|NCT01347086|EG002|Reported Event|800 mg Deleobuvir|All (Japanese and Chinese) subjects that received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition.
11058234|NCT01347086|EG003|Reported Event|1200 mg Deleobuvir|All (Caucasian, Japanese and Chinese) subjects that received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition.
11058235|NCT01347112|BG000|Baseline|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
11058236|NCT01347112|BG001|Baseline|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
11058237|NCT01347112|BG002|Baseline|Total|Total of all reporting groups
11058238|NCT01347112|FG000|Participant Flow|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
11058239|NCT01347112|FG001|Participant Flow|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
11058240|NCT01347112|OG000|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
11058241|NCT01347112|OG001|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
11058242|NCT01347112|OG001|Outcome|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
11058243|NCT01347112|EG000|Reported Event|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
11058244|NCT01347112|EG001|Reported Event|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
11058245|NCT01347255|BG000|Baseline|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:~LEO 90100 cutaneous spray, ointment: once daily application, 4 weeks (6 days a week)~LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks (6 days a week)~LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4 weeks (6 days a week)~Daivobet® ointment: once daily application, 4 weeks (6 days a week)"
10887112|NCT00498706|OG000|Outcome|Telephone-administered Cognitive Behavioral Therapy|Participants will receive telephone-administered cognitive behavioral therapy.
11058246|NCT01347255|FG000|Participant Flow|All Study Participants|"All subjects received all four treatments:~LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)~LEO 90100 cutaneous spray, ointment, vehicle w. betamethasone. Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)~LEO 90100 cutaneous spray, ointment, vehicle. Served as a negative control for the two cutaneous spray ointments with active ingredients~Daivobet® ointment. Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)~Four test sites of approximately 5 cm2 were selected on predetermined psoriasis lesions (target plaques), delimited with a disposable circular device and mapped on a drawn figure.~The distance between two test sites was at least 2 cm. The products were applied on the four test sites (according to random assignment to specific test sites selected on the psoriasis plaque) once daily 6 days a week (except Sundays) for 4 weeks."
11058247|NCT01347255|OG000|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
11058248|NCT01347255|OG001|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
11058249|NCT01347255|OG002|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
11058250|NCT01347255|OG003|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
11058251|NCT01347255|EG000|Reported Event|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:~LEO 90100 cutaneous spray, ointment: once daily application, 4weeks~LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks~LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4weeks~Daivobet® ointment: once daily application, 4weeks"
11058252|NCT01347307|BG000|Baseline|SBRT for Benign Extradural Spine Tumors|"Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).~SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)"
11058253|NCT01347307|BG001|Baseline|SBRT for Vertebral/Paraspinal Metastases|"Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy~SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)"
11058254|NCT01347307|BG002|Baseline|Total|Total of all reporting groups
11058255|NCT01347307|FG000|Participant Flow|SBRT for Benign Extradural Spine Tumors|"Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).~Stereotactic Body Radiation Therapy (SBRT) for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)"
11058256|NCT01347307|FG001|Participant Flow|SBRT for Vertebral/Paraspinal Metastases|"Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy~SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)"
11058257|NCT01347307|OG000|Outcome|SBRT for Benign Extradural Spine Tumors|"Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).~SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)"
11058258|NCT01347307|OG001|Outcome|SBRT for Vertebral/Paraspinal Metastases|"Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy~SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)"
11058259|NCT01347307|EG000|Reported Event|SBRT for Benign Extradural Spine Tumors|"Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).~SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)"
11058260|NCT01347307|EG001|Reported Event|SBRT for Vertebral/Paraspinal Metastases|"Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy~SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)"
11058261|NCT01347333|BG000|Baseline|Liver Metastases|"Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes~Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)"
11058262|NCT01347333|BG001|Baseline|Primary Liver Tumors|"Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma~Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)"
11058263|NCT01347333|BG002|Baseline|Total|Total of all reporting groups
11058264|NCT01347333|FG000|Participant Flow|Liver Metastases|"Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes~Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)"
11058265|NCT01347333|FG001|Participant Flow|Primary Liver Tumors|"Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma~Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)"
11058266|NCT01347333|OG000|Outcome|Liver Metastases|"Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes~Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)"
11058267|NCT01347333|OG001|Outcome|Primary Liver Tumors|"Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma~Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)"
11058268|NCT01347333|EG000|Reported Event|Liver Metastases|"Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes~Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)"
11058269|NCT01347333|EG001|Reported Event|Primary Liver Tumors|"Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma~Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)"
11058270|NCT01347541|BG000|Baseline|Stepped Care|"Combination of behavioral therapy and drug therapy~Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.~Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.~FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."
11058271|NCT01347541|BG001|Baseline|Standard Care Provided to Injured Trauma Survivors|Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
11058272|NCT01347541|BG002|Baseline|Total|Total of all reporting groups
11058273|NCT01347541|FG000|Participant Flow|Stepped Care|"Combination of behavioral therapy and drug therapy~Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.~Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.~FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."
11058274|NCT01347541|FG001|Participant Flow|Standard Care Provided to Injured Trauma Survivors|Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
11058275|NCT01347541|OG000|Outcome|Stepped Care|"Combination of behavioral therapy and drug therapy~Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.~Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.~FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."
11058276|NCT01347541|OG001|Outcome|Standard Care Provided to Injured Trauma Survivors|Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
11058277|NCT01347541|EG000|Reported Event|Stepped Care|"Combination of behavioral therapy and drug therapy~Cognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.~Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.~FDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."
11058278|NCT01347541|EG001|Reported Event|Standard Care Provided to Injured Trauma Survivors|Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
11058279|NCT01347554|BG000|Baseline|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
11058280|NCT01347554|BG001|Baseline|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
11058281|NCT01347554|BG002|Baseline|Total|Total of all reporting groups
11058282|NCT01347554|FG000|Participant Flow|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
11058283|NCT01347554|FG001|Participant Flow|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
11058284|NCT01347554|OG000|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
11058285|NCT01347554|OG001|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
11058286|NCT01347554|EG000|Reported Event|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
11058287|NCT01347554|EG001|Reported Event|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
11058288|NCT01347580|BG000|Baseline|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
11058289|NCT01347580|BG001|Baseline|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
11058290|NCT01347580|BG002|Baseline|Total|Total of all reporting groups
10887113|NCT00498706|OG001|Outcome|Face-to-face Cognitive Behavioral Therapy|Participants will receive face-to-face cognitive behavioral therapy.
11058291|NCT01347580|FG000|Participant Flow|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
11058292|NCT01347580|FG001|Participant Flow|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
11058293|NCT01347580|OG000|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
11058294|NCT01347580|OG001|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
11058295|NCT01347580|EG000|Reported Event|Ticagrelor In-Hosp|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
11058296|NCT01347580|EG001|Reported Event|Ticagrelor Pre-Hosp|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
11058297|NCT01347710|BG000|Baseline|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
11058298|NCT01347710|FG000|Participant Flow|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
11058299|NCT01347710|OG000|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
11058300|NCT01347710|OG000|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
11058301|NCT01347710|OG000|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
11058302|NCT01347710|OG000|Outcome|Flurpiridaz F18 PET MPI|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
11058303|NCT01347710|OG000|Outcome|Flurpiridaz F18|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
11058304|NCT01347710|EG000|Reported Event|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
11058305|NCT01347762|BG000|Baseline|Nabilone Titrated 2 mg Daily (Phase 1)|"nabilone titrated to 2 mg daily~Nabilone: nabilone titrated to 1 mg by mouth twice daily"
11058306|NCT01347762|BG001|Baseline|Placebo (Phase 1)|"Placebo~Placebo: one placebo capsule by mouth twice daily"
11058307|NCT01347762|BG002|Baseline|Nabilone Titrated to 4 mg Daily (Phase 2)|"nabilone titrated to 4 mg daily~Nabilone: nabilone titrated to 2 mg by mouth twice daily"
11058308|NCT01347762|BG003|Baseline|Placebo (Phase 2)|"Placebo~Placebo: one placebo capsule by mouth twice daily"
11058309|NCT01347762|BG004|Baseline|Total|Total of all reporting groups
11058310|NCT01347762|FG000|Participant Flow|Nabilone Titrated 2 mg Daily (Phase 1)|"nabilone titrated to 2 mg daily~Nabilone: nabilone titrated to 1 mg by mouth twice daily"
11058311|NCT01347762|FG001|Participant Flow|Placebo (Phase 1)|"Placebo~Placebo: one placebo capsule by mouth twice daily"
11058312|NCT01347762|FG002|Participant Flow|Nabilone Titrated to 4 mg Daily (Phase 2)|"nabilone titrated to 4 mg daily~Nabilone: nabilone titrated to 2 mg by mouth twice daily"
11058313|NCT01347762|FG003|Participant Flow|Placebo (Phase 2)|"Placebo~Placebo: one placebo capsule by mouth twice daily"
11058314|NCT01347762|OG000|Outcome|Nabilone Titrated 2 mg Daily (Phase 1)|"nabilone titrated to 2 mg daily~Nabilone: nabilone titrated to 1 mg by mouth twice daily"
11058315|NCT01347762|OG001|Outcome|Placebo (Phase 1)|"Placebo~Placebo: one placebo capsule by mouth twice daily"
11058316|NCT01347762|OG002|Outcome|Nabilone Titrated to 4 mg Daily (Phase 2)|"nabilone titrated to 4 mg daily~Nabilone: nabilone titrated to 2 mg by mouth twice daily"
11058317|NCT01347762|OG003|Outcome|Placebo (Phase 2)|"Placebo~Placebo: one placebo capsule by mouth twice daily"
11058318|NCT01347762|EG000|Reported Event|Nabilone Titrated 2 mg Daily (Phase 1)|"nabilone titrated to 2 mg daily~Nabilone: nabilone titrated to 1 mg by mouth twice daily"
11058319|NCT01347762|EG001|Reported Event|Placebo (Phase 1)|"Placebo~Placebo: one placebo capsule by mouth twice daily"
11058320|NCT01347762|EG002|Reported Event|Nabilone Titrated to 4 mg Daily (Phase 2)|"nabilone titrated to 4 mg daily~Nabilone: nabilone titrated to 2 mg by mouth twice daily"
11058321|NCT01347762|EG003|Reported Event|Placebo (Phase 2)|"Placebo~Placebo: one placebo capsule by mouth twice daily"
11058322|NCT01347788|BG000|Baseline|Cabozantinib|"Final results have been published Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3.~A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases.~Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR.~Author information Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA. rjlee@partners.org"
11058323|NCT01347788|FG000|Participant Flow|Dose Level 0|Cabozantinib 40 mg daily
11058324|NCT01347788|FG001|Participant Flow|Dose Level -1|Cabozantinib 20 mg daily
11058325|NCT01347788|FG002|Participant Flow|Expansion Cohort|Cabozantinib 40 mg daily
11058326|NCT01347788|OG000|Outcome|Cohort 1|Dose level 0: cabozantinib 40 mg daily
11058327|NCT01347788|OG001|Outcome|Cohort 2|Dose level -1: cabozantinib 20 mg daily
11058328|NCT01347788|OG002|Outcome|Expansion Cohort|Dose level 0: cabozantinib 40 mg daily
11058329|NCT01347788|EG000|Reported Event|Cohort 1|Dose level 0: cabozantinib 40 mg daily
11058330|NCT01347788|EG001|Reported Event|Cohort 2|Dose level -1: cabozantinib 20 mg daily
11058331|NCT01347788|EG002|Reported Event|Cohort 3|Dose level 0: cabozantinib 40 mg daily
11058332|NCT01347866|BG000|Baseline|PF-04691502+PF-0325901: Arm A1 (Stage1)|Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058333|NCT01347866|BG001|Baseline|PF-04691502+PF 0325901: Arm A2 (Stage1)|Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058334|NCT01347866|BG002|Baseline|PF-04691502+PF 0325901: Arm A4 (Stage1)|Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058335|NCT01347866|BG003|Baseline|PF-04691502+Irinotecan: Arm B1 (Stage 1)|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058336|NCT01347866|BG004|Baseline|PF-04691502+Irinotecan: Arm B2 (Stage 1)|Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058337|NCT01347866|BG005|Baseline|PF-05212384+Irinotecan: Arm C1 (Stage 1)|Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058338|NCT01347866|BG006|Baseline|PF-05212384+Irinotecan: Arm C2 (Stage 1)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058339|NCT01347866|BG007|Baseline|PF-05212384+Irinotecan: Arm C3 (Stage 1)|Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058340|NCT01347866|BG008|Baseline|PF-05212384+Irinotecan: Arm C2 (Stage 2)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
11058341|NCT01347866|BG009|Baseline|PF-05212384+ PD-0325901: Arm D0 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058342|NCT01347866|BG010|Baseline|PF-05212384+ PD-0325901: Arm D0A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058343|NCT01347866|BG011|Baseline|PF-05212384+ PD-0325901: Arm D0B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11349037|NCT04128293|BG003|Baseline|Sequence 4 - Treatment DCBA|Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
11058344|NCT01347866|BG012|Baseline|PF-05212384+ PD-0325901: Arm D1 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058345|NCT01347866|BG013|Baseline|PF-05212384+ PD-0325901: Arm D1A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058346|NCT01347866|BG014|Baseline|PF-05212384+ PD-0325901: Arm D1B (Stage 1))|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058347|NCT01347866|BG015|Baseline|PF-05212384+ PD-0325901: Arm D2 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058348|NCT01347866|BG016|Baseline|PF-05212384+ PD-0325901: Arm D2A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058349|NCT01347866|BG017|Baseline|Total|Total of all reporting groups
11058350|NCT01347866|FG000|Participant Flow|PF-04691502+PF-0325901: Arm A1 (Stage1)|Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058351|NCT01347866|FG001|Participant Flow|PF-04691502+PF 0325901: Arm A2 (Stage1)|Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058352|NCT01347866|FG002|Participant Flow|PF-04691502+PF 0325901: Arm A4 (Stage1)|Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058353|NCT01347866|FG003|Participant Flow|PF-04691502+Irinotecan: Arm B1 (Stage 1)|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058354|NCT01347866|FG004|Participant Flow|PF-04691502+Irinotecan: Arm B2 (Stage 1)|Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058355|NCT01347866|FG005|Participant Flow|PF-05212384+Irinotecan: Arm C1 (Stage 1)|Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058356|NCT01347866|FG006|Participant Flow|PF-05212384+Irinotecan: Arm C2 (Stage 1)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058357|NCT01347866|FG007|Participant Flow|PF-05212384+Irinotecan: Arm C3 (Stage 1)|Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058358|NCT01347866|FG008|Participant Flow|PF-05212384+Irinotecan: Arm C2 (Stage 2)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
11058359|NCT01347866|FG009|Participant Flow|PF-05212384+ PD-0325901: Arm D0 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058360|NCT01347866|FG010|Participant Flow|PF-05212384+ PD-0325901: Arm D0A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058361|NCT01347866|FG011|Participant Flow|PF-05212384+ PD-0325901: Arm D0B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11066819|NCT01393990|OG001|Outcome|Part A: 20 mg LY2228820 Capsules|20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11349038|NCT04128293|BG004|Baseline|Total|Total of all reporting groups
11058362|NCT01347866|FG012|Participant Flow|PF-05212384+PD-0325901: Arm D1 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058363|NCT01347866|FG013|Participant Flow|PF-05212384+ PD-0325901: Arm D1A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058364|NCT01347866|FG014|Participant Flow|PF-05212384+PD-0325901: Arm D1B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058365|NCT01347866|FG015|Participant Flow|PF-05212384+ PD-0325901: Arm D2 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058366|NCT01347866|FG016|Participant Flow|PF-05212384+ PD-0325901: Arm D2A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058367|NCT01347866|OG000|Outcome|PF-04691502+PF-0325901: Arm A1 (Stage1)|Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058368|NCT01347866|OG001|Outcome|PF-04691502+PF 0325901: Arm A2 (Stage1)|Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058369|NCT01347866|OG002|Outcome|PF-04691502+PF 0325901: Arm A4 (Stage1)|Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058370|NCT01347866|OG003|Outcome|PF-04691502+Irinotecan: Arm B1 (Stage 1)|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058371|NCT01347866|OG004|Outcome|PF-04691502+Irinotecan: Arm B2 (Stage 1)|Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058372|NCT01347866|OG005|Outcome|PF-05212384+Irinotecan: Arm C1 (Stage 1)|Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058373|NCT01347866|OG006|Outcome|PF-05212384+Irinotecan: Arm C2 (Stage 1)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058374|NCT01347866|OG007|Outcome|PF-05212384+Irinotecan: Arm C3 (Stage 1)|Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058375|NCT01347866|OG008|Outcome|PF-05212384+ PD-0325901: Arm D0 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058376|NCT01347866|OG009|Outcome|PF-05212384+ PD-0325901: Arm D0A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11066820|NCT01393990|OG002|Outcome|Part A: 40 mg LY2228820 Capsules|40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11058377|NCT01347866|OG010|Outcome|PF-05212384+ PD-0325901: Arm D0B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058378|NCT01347866|OG011|Outcome|PF-05212384+ PD-0325901: Arm D1 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058379|NCT01347866|OG012|Outcome|PF-05212384+ PD-0325901: Arm D1A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058380|NCT01347866|OG013|Outcome|PF-05212384+PD-0325901: Arm D1B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058381|NCT01347866|OG014|Outcome|PF-05212384+PD-0325901: Arm D2 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058382|NCT01347866|OG015|Outcome|PF-05212384+ PD-0325901: Arm D2A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058383|NCT01347866|OG008|Outcome|PF-05212384+Irinotecan: Arm C2 (Stage 2)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
11058384|NCT01347866|OG009|Outcome|PF-05212384+ PD-0325901: Arm D0 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058385|NCT01347866|OG010|Outcome|PF-05212384+ PD-0325901: Arm D0A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058386|NCT01347866|OG011|Outcome|PF-05212384+ PD-0325901: Arm D0B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058387|NCT01347866|OG012|Outcome|PF-05212384+ PD-0325901: Arm D1 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058388|NCT01347866|OG013|Outcome|PF-05212384+ PD-0325901: Arm D1A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058389|NCT01347866|OG014|Outcome|PF-05212384+PD-0325901: Arm D1B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11066821|NCT01393990|OG003|Outcome|Part A: 65 mg LY2228820 Capsules|65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11058390|NCT01347866|OG015|Outcome|PF-05212384+PD-0325901: Arm D2 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058391|NCT01347866|OG016|Outcome|PF-05212384+ PD-0325901: Arm D2A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058392|NCT01347866|OG000|Outcome|PF-05212384+Irinotecan: Arm C1 (Stage 1)|Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058393|NCT01347866|OG001|Outcome|PF-05212384+Irinotecan: Arm C2 (Stage 1)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058394|NCT01347866|OG002|Outcome|PF-05212384+Irinotecan: Arm C3 (Stage 1)|Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058395|NCT01347866|OG003|Outcome|PF-05212384+Irinotecan: Arm C2 (Stage 2)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
11058396|NCT01347866|OG000|Outcome|PF-05212384+ PD-0325901: Arm D0 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058397|NCT01347866|OG001|Outcome|PF-05212384+ PD-0325901: Arm D0A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058398|NCT01347866|OG002|Outcome|PF-05212384+ PD-0325901: Arm D0B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058399|NCT01347866|OG003|Outcome|PF-05212384+ PD-0325901: Arm D1 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058400|NCT01347866|OG004|Outcome|PF-05212384+ PD-0325901: Arm D1A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058401|NCT01347866|OG005|Outcome|PF-05212384+PD-0325901: Arm D1B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058402|NCT01347866|OG006|Outcome|PF-05212384+PD-0325901: Arm D2 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058403|NCT01347866|OG007|Outcome|PF-05212384+ PD-0325901: Arm D2A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058404|NCT01347866|OG000|Outcome|PF-04691502+Irinotecan: Arm B1 (Stage 1)|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058405|NCT01347866|OG001|Outcome|PF-04691502+Irinotecan: Arm B2 (Stage 1)|Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058406|NCT01347866|OG000|Outcome|PF-05212384+Irinotecan: Arm C2 (Stage 2)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
11058407|NCT01347866|OG002|Outcome|PF-05212384+Irinotecan: Arm C1 (Stage 1)|Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058408|NCT01347866|OG003|Outcome|PF-05212384+Irinotecan: Arm C2 (Stage 1)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058409|NCT01347866|OG004|Outcome|PF-05212384+Irinotecan: Arm C3 (Stage 1)|Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058410|NCT01347866|OG005|Outcome|PF-05212384+Irinotecan: Arm C2 (Stage 2)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
11058411|NCT01347866|OG006|Outcome|PF-05212384+ PD-0325901: Arm D0 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058412|NCT01347866|OG007|Outcome|PF-05212384+ PD-0325901: Arm D0A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058413|NCT01347866|OG008|Outcome|PF-05212384+ PD-0325901: Arm D0B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058414|NCT01347866|OG009|Outcome|PF-05212384+ PD-0325901: Arm D1 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058415|NCT01347866|OG010|Outcome|PF-05212384+ PD-0325901: Arm D1A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058416|NCT01347866|OG011|Outcome|PF-05212384+PD-0325901: Arm D1B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058417|NCT01347866|OG012|Outcome|PF-05212384+PD-0325901: Arm D2 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058418|NCT01347866|OG013|Outcome|PF-05212384+ PD-0325901: Arm D2A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058419|NCT01347866|EG000|Reported Event|PF-04691502+PF-0325901: Arm A1 (Stage1)|Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11066822|NCT01393990|OG004|Outcome|Part A: 90 mg LY2228820 Capsules|90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
10887114|NCT00498706|EG000|Reported Event|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
11058420|NCT01347866|EG001|Reported Event|PF-04691502+PF 0325901: Arm A2 (Stage1)|Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058421|NCT01347866|EG002|Reported Event|PF-04691502+PF 0325901: Arm A4 (Stage1)|Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058422|NCT01347866|EG003|Reported Event|PF-04691502+Irinotecan: Arm B1 (Stage 1)|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058423|NCT01347866|EG004|Reported Event|PF-04691502+Irinotecan: Arm B2 (Stage 1)|Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058424|NCT01347866|EG005|Reported Event|PF-05212384+Irinotecan: Arm C1 (Stage 1)|Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058425|NCT01347866|EG006|Reported Event|PF-05212384+Irinotecan: Arm C2 (Stage 1)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058426|NCT01347866|EG007|Reported Event|PF-05212384+Irinotecan: Arm C3 (Stage 1)|Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly.
11058427|NCT01347866|EG008|Reported Event|PF-05212384+Irinotecan: Arm C2 (Stage 2)|Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
11058428|NCT01347866|EG009|Reported Event|PF-05212384+ PD-0325901: Arm D0 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058429|NCT01347866|EG010|Reported Event|PF-05212384+PD-0325901: Arm D0A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058430|NCT01347866|EG011|Reported Event|PF-05212384+ PD-0325901: Arm D0B (Stage 1)|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058431|NCT01347866|EG012|Reported Event|PF-05212384+ PD-0325901: Arm D1 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058432|NCT01347866|EG013|Reported Event|PF-05212384+ PD-0325901: Arm D1A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058433|NCT01347866|EG014|Reported Event|PF-05212384+ PD-0325901: Arm D1B (Stage 1))|Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058434|NCT01347866|EG015|Reported Event|PF-05212384+ PD-0325901: Arm D2 (Stage 1)|Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11066823|NCT01393990|OG005|Outcome|Part A: 120 mg LY2228820 Capsules|120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
10887115|NCT00498706|EG001|Reported Event|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
11058435|NCT01347866|EG016|Reported Event|PF-05212384+ PD-0325901: Arm D2A (Stage 1)|Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
11058436|NCT01347879|BG000|Baseline|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
11058437|NCT01347879|BG001|Baseline|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
11226713|NCT02377427|EG004|Reported Event|Part B: Mepolizumab 40/100 mg SC|Participants received either 0.4 mL or 1.0 mL of reconstituted mepolizumab depending upon the bodyweight, administered subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. Participants enrolled to <40 kg at Visit 9 (Week 20) were summarized in the 40/100 mg SC group if they had weight >=40 kg at any subsequent visit.
11058438|NCT01347879|BG002|Baseline|Total|Total of all reporting groups
11058439|NCT01347879|FG000|Participant Flow|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
11058440|NCT01347879|FG001|Participant Flow|Visonac Cream With PDT|"active treatment with light dose of 37 J/cm2~Visonac photodynamic therapy (PDT): cream application prior to illumination with red light"
11058441|NCT01347879|OG000|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
11058442|NCT01347879|OG001|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
11058443|NCT01347879|EG000|Reported Event|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
11058444|NCT01347879|EG001|Reported Event|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
11058445|NCT01347931|BG000|Baseline|Overall Study Group|All subjects participating in 2-way crossover design study
11058446|NCT01347931|FG000|Participant Flow|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
11058447|NCT01347931|OG000|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
11058448|NCT01347931|OG001|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
11058449|NCT01347931|EG000|Reported Event|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
11058450|NCT01347931|EG001|Reported Event|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
11058451|NCT01348087|BG000|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
10849058|NCT00293423|EG001|Reported Event|Phase 2: Vaccine|Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
11058452|NCT01348087|FG000|Participant Flow|AFQ056 Total|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
11058453|NCT01348087|OG000|Outcome|Prior to Ext First Dose|
11058454|NCT01348087|OG001|Outcome|AFQ056 25mg Bid|
11058455|NCT01348087|OG002|Outcome|AFQ056 50mg Bid|
11058456|NCT01348087|OG003|Outcome|AFQ056 75mg Bid|
11058457|NCT01348087|OG004|Outcome|AFQ056 100mg Bid|
11058458|NCT01348087|OG005|Outcome|AFQ056 Total|
11058459|NCT01348087|EG000|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
11058460|NCT01348087|EG001|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
11058461|NCT01348087|EG002|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
11058462|NCT01348087|EG003|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
11058463|NCT01348087|EG004|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
11058464|NCT01348087|EG005|Reported Event|AFQ056 Total|
11058465|NCT01348100|BG000|Baseline|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
11058466|NCT01348100|BG001|Baseline|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
11058467|NCT01348100|BG002|Baseline|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058468|NCT01348100|BG003|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058469|NCT01348100|BG004|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058470|NCT01348100|BG005|Baseline|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058471|NCT01348100|BG006|Baseline|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058472|NCT01348100|BG007|Baseline|Total|Total of all reporting groups
11058473|NCT01348100|FG000|Participant Flow|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
11058474|NCT01348100|FG001|Participant Flow|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
11058475|NCT01348100|FG002|Participant Flow|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058476|NCT01348100|FG003|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058477|NCT01348100|FG004|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058478|NCT01348100|FG005|Participant Flow|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058479|NCT01348100|FG006|Participant Flow|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058480|NCT01348100|OG000|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058481|NCT01348100|OG001|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058482|NCT01348100|OG000|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058483|NCT01348100|OG001|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058484|NCT01348100|OG002|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058485|NCT01348100|EG000|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
11058486|NCT01348100|EG001|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
11058487|NCT01348100|EG002|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time.
11058488|NCT01348100|EG003|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time.
11058489|NCT01348100|EG004|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058490|NCT01348100|EG005|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058491|NCT01348100|EG006|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Depot|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time.
11058492|NCT01348100|EG007|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time.
11058493|NCT01348100|EG008|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058494|NCT01348100|EG009|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058495|NCT01348100|EG010|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
11058496|NCT01348100|EG011|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart.
11058497|NCT01348100|EG012|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart.
11058498|NCT01348100|EG013|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart.
11058499|NCT01348139|BG000|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
11058500|NCT01348139|FG000|Participant Flow|1400 μg / Placebo / 880 μg / 1200 μg / 800 μg / 300 μg|AZD3199 1400 μg SID followed by Placebo followed by AZD3199 880 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 300 μg Turbuhaler inhaler.
11058501|NCT01348139|FG001|Participant Flow|880 μg / 1400 μg / 800 μg / Placebo / 300 μg / 1200 μg|AZD3199 880 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 800 μg SID followed by Placebo followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1200 μg Turbuhaler inhaler.
11058502|NCT01348139|FG002|Participant Flow|800 μg / 880 μg / 300 μg / 1400 μg / 1200 μg / Placebo|AZD3199 800 μg SID followed by AZD3199 880 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by Placebo.
11058503|NCT01348139|FG003|Participant Flow|300 μg / 800 μg / 1200 μg / 880 μg / Placebo / 1400 μg|AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by Placebo followed by AZD3199 1400 μg SID.
11058504|NCT01348139|FG004|Participant Flow|1200 μg / 300 μg / Placebo / 800 μg / 1400 μg / 880 μg|AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 300 μg Turbuhaler inhaler followed by Placebo followed by AZD3199 800 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 880 μg SID.
11058505|NCT01348139|FG005|Participant Flow|Placebo / 1200 μg / 1400 μg / 300 μg / 880 μg / 800 μg|Placebo followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by AZD3199 800 μg SID.
11058506|NCT01348139|OG000|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
11058507|NCT01348139|OG001|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
11058508|NCT01348139|OG002|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
11058509|NCT01348139|OG003|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
11058510|NCT01348139|OG004|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
11058511|NCT01348139|OG005|Outcome|Arm 6 - Placebo|Placebo
11058512|NCT01348139|EG000|Reported Event|AZD3199 1400 μg|AZD3199 1400 μg SID
11058513|NCT01348139|EG001|Reported Event|AZD3199 880 μg|AZD3199 880 μg SID
11058514|NCT01348139|EG002|Reported Event|AZD3199 800 μg|AZD3199 800 μg SID
11058515|NCT01348139|EG003|Reported Event|AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
11058516|NCT01348139|EG004|Reported Event|AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
11058517|NCT01348139|EG005|Reported Event|Placebo|Placebo
11058518|NCT01348165|BG000|Baseline|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
11058519|NCT01348165|BG001|Baseline|0.01 mg|BI 137882 with 0.01 mg Dose level
11058520|NCT01348165|BG002|Baseline|0.03 mg|BI 137882 with 0.03 mg Dose level
11058521|NCT01348165|BG003|Baseline|0.1 mg|BI 137882 with 0.1 mg Dose level
11058522|NCT01348165|BG004|Baseline|0.25 mg|BI 137882 with 0.25 mg Dose level
11058523|NCT01348165|BG005|Baseline|0.5 mg|BI 137882 with 0.5 mg Dose level
11058524|NCT01348165|BG006|Baseline|0.6 mg|BI 137882 with 0.6 mg Dose level
11058525|NCT01348165|BG007|Baseline|Total|Total of all reporting groups
11058526|NCT01348165|FG000|Participant Flow|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
11058527|NCT01348165|FG001|Participant Flow|0.01 mg|BI 137882 with 0.01 mg Dose level
11058528|NCT01348165|FG002|Participant Flow|0.03 mg|BI 137882 with 0.03 mg Dose level
11058529|NCT01348165|FG003|Participant Flow|0.1 mg|BI 137882 with 0.1 mg Dose level
11058530|NCT01348165|FG004|Participant Flow|0.25 mg|BI 137882 with 0.25 mg Dose level
11058531|NCT01348165|FG005|Participant Flow|0.5 mg|BI 137882 with 0.5 mg Dose level
11058532|NCT01348165|FG006|Participant Flow|0.6 mg|BI 137882 with 0.6 mg Dose level
11058533|NCT01348165|OG000|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
11058534|NCT01348165|OG001|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
11058535|NCT01348165|OG002|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
11058536|NCT01348165|OG003|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
11058537|NCT01348165|OG004|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
11058538|NCT01348165|OG005|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
11058539|NCT01348165|OG006|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
11058540|NCT01348165|OG000|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
11058541|NCT01348165|OG001|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
11058542|NCT01348165|OG002|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
11058543|NCT01348165|OG005|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
11058544|NCT01348165|EG000|Reported Event|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
11058545|NCT01348165|EG001|Reported Event|0.01 mg|BI 137882 with 0.01 mg Dose level
11058546|NCT01348165|EG002|Reported Event|0.03 mg|BI 137882 with 0.03 mg Dose level
11058547|NCT01348165|EG003|Reported Event|0.1 mg|BI 137882 with 0.1 mg Dose level
11058548|NCT01348165|EG004|Reported Event|0.25 mg|BI 137882 with 0.25 mg Dose level
11058549|NCT01348165|EG005|Reported Event|0.5 mg|BI 137882 with 0.5 mg Dose level
11058550|NCT01348165|EG006|Reported Event|0.6 mg|BI 137882 with 0.6 mg Dose level
11058551|NCT01348347|BG000|Baseline|Volasertib 200 mg Cohort|Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058552|NCT01348347|BG001|Baseline|Volasertib 300 mg Cohort|Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058553|NCT01348347|BG002|Baseline|Volasertib 350 mg Cohort|Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058554|NCT01348347|BG003|Baseline|Total|Total of all reporting groups
11058555|NCT01348347|FG000|Participant Flow|Volasertib 200 mg Cohort|Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058556|NCT01348347|FG001|Participant Flow|Volasertib 300 mg Cohort|Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058557|NCT01348347|FG002|Participant Flow|Volasertib 350 mg Cohort|Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058558|NCT01348347|OG000|Outcome|Volasertib 200 mg Cohort|Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058559|NCT01348347|OG001|Outcome|Volasertib 300 mg Cohort|Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058560|NCT01348347|OG002|Outcome|Volasertib 350 mg Cohort|Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058561|NCT01348347|OG000|Outcome|Volasertib Cohort|Volasertib with 200mg, 300mg and 350mg were infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course .
11058562|NCT01348347|EG000|Reported Event|Volasertib 200 mg Cohort|Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058563|NCT01348347|EG001|Reported Event|Volasertib 300 mg Cohort|Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058564|NCT01348347|EG002|Reported Event|Volasertib 350 mg Cohort|Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
11058565|NCT01348425|BG000|Baseline|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
11058566|NCT01348425|BG001|Baseline|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
11058567|NCT01348425|BG002|Baseline|Total|Total of all reporting groups
11058568|NCT01348425|FG000|Participant Flow|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
11058569|NCT01348425|FG001|Participant Flow|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
11058570|NCT01348425|OG000|Outcome|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
11058571|NCT01348425|OG001|Outcome|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
11058572|NCT01348425|EG000|Reported Event|Stented Patients|The adverse events were combined because all patients were treated with Zilver PTX stents. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. immediately post-procedure.
11058573|NCT01348490|BG000|Baseline|Ruxolitinib 5 mg|"Doses may not exceed 10 mg bid except in subjects who continue to meet the above dose escalation criteria, and who have, in addition, a PGIC score of minimally worse, much worse or very much worse while receiving 10 mg bid. Such subjects may continue dose escalation to a maximum dose of 15 mg bid.~During the extended treatment phase, doses of ruxolitinib may be increased in 5 mg qd increments up to a dose of 25 mg bid if the subject meets the above dose escalation criteria, or per the investigator's discretion."
11058574|NCT01348490|FG000|Participant Flow|Ruxolitinib 5 Milligram (mg)|"Doses may not exceed 10 mg bid except in subjects who continue to meet the above dose escalation criteria, and who have, in addition, a PGIC score of minimally worse, much worse or very much worse while receiving 10 mg bid. Such subjects may continue dose escalation to a maximum dose of 15 mg bid.~During the extended treatment phase, doses of ruxolitinib may be increased in 5 mg qd increments up to a dose of 25 mg bid if the subject meets the above dose escalation criteria, or per the investigator's discretion."
11058575|NCT01348490|OG000|Outcome|5 mg QD or 5 mg BID|Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
11058576|NCT01348490|OG001|Outcome|5 mg AM/ 10 mg PM|Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
11058577|NCT01348490|OG002|Outcome|10 mg BID|Participants received the final titrated dose of ruxolitinib 10 mg BID.
11058578|NCT01348490|OG003|Outcome|10 mg AM/ 15 mg PM or 15 mg BID|Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
11058579|NCT01348490|OG000|Outcome|>0 - 5 mg|Participants received ruxolitinib up to 0-5mg.
11058580|NCT01348490|OG001|Outcome|>5 - 10 mg|Participants received ruxolitinib in the range of 6 mg to 10 mg.
11058581|NCT01348490|OG002|Outcome|>10 - 15 mg|Participants received ruxolitinib in the range of 11 to 15 mg.
11058582|NCT01348490|OG003|Outcome|>15 - 20 mg|Participants received ruxolitinib in the range of 16 to 20 mg.
11058583|NCT01348490|OG004|Outcome|>20 mg|Participants received ruxolitinib, more than 20 mg.
11058584|NCT01348490|OG000|Outcome|>0 - 5 mg|Participants received ruxolitinib up to 5 mg.
11058585|NCT01348490|OG001|Outcome|>5 - 10 mg|Participants received ruxolitinib in the range of 5 to 10 mg.
11058586|NCT01348490|OG002|Outcome|>10 - 15 mg|Participants received ruxolitinib in the range of 10 to 15 mg.
11058587|NCT01348490|OG003|Outcome|>15 - 20 mg|Participants received ruxolitinib in the range of 15 to 20 mg.
11058588|NCT01348490|OG000|Outcome|Ruxolitinib|Participants who received ruxolitinib doses as 5 mg QD or 5 mg BID, 5 mg AM/ 10 mg PM, 10 mg BID, and 10 mg AM/ 15 mg PM or 15 mg BID.
11058589|NCT01348490|EG000|Reported Event|>0 - 5 mg|Participants received ruxolitinib up to 5 mg.
11058590|NCT01348490|EG001|Reported Event|>5 - 10 mg|Participants received ruxolitinib in the range of 5 to 10 mg.
11058591|NCT01348490|EG002|Reported Event|>10 - 15 mg|Participants received ruxolitinib in the range of 10 to 15 mg.
11058592|NCT01348490|EG003|Reported Event|>15 - 20 mg|Participants received ruxolitinib in the range of 15 to 20 mg.
11058593|NCT01348490|EG004|Reported Event|>20 mg|Participants received ruxolitinib, more than 20 mg.
11058594|NCT01348542|BG000|Baseline|Trazodone|Trazodone: 50 mg once a day, for 3 months
11058595|NCT01348542|BG001|Baseline|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.
11058596|NCT01348542|BG002|Baseline|Total|Total of all reporting groups
11058597|NCT01348542|FG000|Participant Flow|Trazodone|Trazodone: 50 mg once a day, for 3 months
11058598|NCT01348542|FG001|Participant Flow|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.
11058599|NCT01348542|OG000|Outcome|Trazodone|Trazodone: 50 mg once a day, for 3 months
11058600|NCT01348542|OG001|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.
11058601|NCT01348542|EG000|Reported Event|Trazodone|Trazodone: 50 mg once a day, for 3 months
11058602|NCT01348542|EG001|Reported Event|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.
11058603|NCT01348607|BG000|Baseline|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
11058604|NCT01348607|BG001|Baseline|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
11058605|NCT01348607|BG002|Baseline|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
11058606|NCT01348607|BG003|Baseline|Total|Total of all reporting groups
11058607|NCT01348607|FG000|Participant Flow|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
11058608|NCT01348607|FG001|Participant Flow|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
11058609|NCT01348607|FG002|Participant Flow|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
11058610|NCT01348607|OG000|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
11058611|NCT01348607|OG001|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
11058612|NCT01348607|OG002|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
11058613|NCT01348607|EG000|Reported Event|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
11058614|NCT01348607|EG001|Reported Event|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
11058615|NCT01348607|EG002|Reported Event|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
11058616|NCT01348698|BG000|Baseline|Adrenal Gland Neoplasm|Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. The majority of adrenal incidentalomas are cortical adenoma. Many patients with nonfunctioning adrenal incidentalomas undergo adrenalectomy to exclude a cancer diagnosis. There are no reliable clinical, radiographic or laboratory studies that accurately distinguish between localized benign and malignant adrenal neoplasm.
11058617|NCT01348698|FG000|Participant Flow|Adrenal Gland Neoplasm|Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. The majority of adrenal incidentalomas are cortical adenoma. Many patients with nonfunctioning adrenal incidentalomas undergo adrenalectomy to exclude a cancer diagnosis. There are no reliable clinical, radiographic or laboratory studies that accurately distinguish between localized benign and malignant adrenal neoplasm.
11058618|NCT01348698|OG000|Outcome|Adrenal Gland Neoplasm|Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. The majority of adrenal incidentalomas are cortical adenoma. Many patients with nonfunctioning adrenal incidentalomas undergo adrenalectomy to exclude a cancer diagnosis. There are no reliable clinical, radiographic or laboratory studies that accurately distinguish between localized benign and malignant adrenal neoplasm.
11058619|NCT01348698|EG000|Reported Event|Adrenal Gland Neoplasm|Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. The majority of adrenal incidentalomas are cortical adenoma. Many patients with nonfunctioning adrenal incidentalomas undergo adrenalectomy to exclude a cancer diagnosis. There are no reliable clinical, radiographic or laboratory studies that accurately distinguish between localized benign and malignant adrenal neoplasm.
10887116|NCT00498797|BG000|Baseline|Vandetanib|docetaxel/prednisolone/vandetanib
11058620|NCT01348763|BG000|Baseline|Truvada, Darunavir/r and Maraviroc|"Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada~Maraviroc: Maraviroc 150 mg daily"
11058621|NCT01348763|FG000|Participant Flow|Truvada, Darunavir/r and Maraviroc|"Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada~Maraviroc: Maraviroc 150 mg daily"
11058622|NCT01348763|OG000|Outcome|Truvada, Darunavir/r and Maraviroc|"Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada~Maraviroc: Maraviroc 150 mg daily"
11058623|NCT01348763|EG000|Reported Event|Truvada, Darunavir/r and Maraviroc|"Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada~Maraviroc: Maraviroc 150 mg daily"
11058624|NCT01348776|BG000|Baseline|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
11058625|NCT01348776|FG000|Participant Flow|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
11058626|NCT01348776|OG000|Outcome|Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
11058627|NCT01348776|OG001|Outcome|Hair2Go (Mē) no Maintenance Side|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
11058628|NCT01348776|OG000|Outcome|Maintenance Side|Hair clearance after 7 weekly treatments+2 additional monthly maintenance treatments
11058629|NCT01348776|OG001|Outcome|No Maintenance Side|Hair clearance after 7 weekly treatments without additional maintenance treatments
11058630|NCT01348776|OG000|Outcome|Anticipated Skin Effects|Anticipated skin effects included mild to moderate sense of warmth, tingling, or itching, and transient erythema and edema.
11058631|NCT01348776|OG000|Outcome|Treatment #1|Self assessment of tolerability level of procedure during 1st treatment
11058632|NCT01348776|OG001|Outcome|Treatment #3|Self assessment of tolerability level of procedure during 3rd treatment
11058633|NCT01348776|OG002|Outcome|Treatment #7|Self assessment of tolerability level of procedure during 7th treatment
11058634|NCT01348776|OG003|Outcome|Maintenance Treatment #3|Self assessment of tolerability level of procedure during 3rd maintenance treatment
11058635|NCT01348776|OG000|Outcome|Hair2Go (Mē)|Subjects treated with the Hair2Go (Me) Device
11058636|NCT01348776|EG000|Reported Event|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
11058637|NCT01348789|BG000|Baseline|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
11058638|NCT01348789|FG000|Participant Flow|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals
11058639|NCT01348789|OG000|Outcome|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
11058640|NCT01348789|OG000|Outcome|Light Skin - Treat#1|Self assessment of tolerability for skin photo-type I-IV after treatment#1.
11058641|NCT01348789|OG001|Outcome|Light Skin - Treat#2|Self assessment of tolerability for skin photo-type I-IV after treatment#2.
11058642|NCT01348789|OG002|Outcome|Light Skin - Treat#3|Self assessment of tolerability for skin photo-type I-IV after treatment#3.
11058643|NCT01348789|OG003|Outcome|Dark Skin - Treat#1|Self assessment of tolerability for skin photo-type V-VI after treatment#1
11058644|NCT01348789|OG004|Outcome|Dark Skin - Treat#2|Self assessment of tolerability for skin photo-type V-VI after treatment#2
11058645|NCT01348789|OG005|Outcome|Dark Skin - Treat#3|Self assessment of tolerability for skin photo-type V-VI after treatment#3
11058646|NCT01348789|OG000|Outcome|Hair Clearance From All Areas|Treatment with Hair2Go (Mē) device
11058647|NCT01348789|EG000|Reported Event|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
11058648|NCT01348828|BG000|Baseline|Ventana Fenestrated System|"All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.~Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System"
11058649|NCT01348828|FG000|Participant Flow|Ventana Fenestrated System|"All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.~Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System"
11058650|NCT01348828|OG000|Outcome|Ventana Fenestrated System|"All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.~Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System"
11058651|NCT01348828|EG000|Reported Event|Ventana Fenestrated System|"All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.~Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System"
11058652|NCT01348854|BG000|Baseline|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
11058653|NCT01348854|BG001|Baseline|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
11058654|NCT01348854|BG002|Baseline|Total|Total of all reporting groups
11058655|NCT01348854|FG000|Participant Flow|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
11058656|NCT01348854|FG001|Participant Flow|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
11058657|NCT01348854|OG000|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
11058658|NCT01348854|OG001|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
11058659|NCT01348854|EG000|Reported Event|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
11058660|NCT01348854|EG001|Reported Event|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
11058661|NCT01349036|BG000|Baseline|PLX3397 - Cohort 1 (Surgical)|Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery.
11058662|NCT01349036|BG001|Baseline|PLX3397 - Cohort 2 (Non-surgical)|Participants with recurrent glioblastoma who received PLX3397 continuously on 28 day cycles.
11058663|NCT01349036|BG002|Baseline|Total|Total of all reporting groups
11058664|NCT01349036|FG000|Participant Flow|PLX3397 - Cohort 1 (Surgical)|Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery.
11058665|NCT01349036|FG001|Participant Flow|PLX3397 - Cohort 2 (Non-surgical)|Participants who received PLX3397 continuously on 28 day cycles.
11058666|NCT01349036|OG000|Outcome|Surgical Cohort 1 (N=14)|Participants with recurrent glioblastoma who were treated with PLX3397 in Cohort 1 (surgical).
11058667|NCT01349036|OG001|Outcome|Non-Surgical Cohort 2 (N=24)|Participants with recurrent glioblastoma who were treated with PLX3397 in Cohort 2 (non-surgical).
11058668|NCT01349036|OG000|Outcome|PLX3397 - Cohort 1 (Surgical)|Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery.
11058669|NCT01349036|OG001|Outcome|PLX3397 - Cohort 2 (Non-surgical)|Participants who received PLX3397 continuously on 28 day cycles.
11058670|NCT01349036|OG000|Outcome|PLX3397 - Cohort 1 (Surgical)|All participants with recurrent glioblastoma who were treated with PLX3397 in Cohort 1 (surgical).
11058671|NCT01349036|OG001|Outcome|PLX3397 - Cohort 2 (Non-surgical)|All participants with recurrent glioblastoma who were treated with PLX3397 in Cohort 2 (non-surgical).
11058672|NCT01349036|EG000|Reported Event|PLX3397 - Cohort 1 (Surgical)|Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery.
11058673|NCT01349036|EG001|Reported Event|PLX3397 - Cohort 2 (Non-surgical)|Participants who received PLX3397 continuously on 28 day cycles.
11058674|NCT01349049|BG000|Baseline|Part 1: 800 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day
11058675|NCT01349049|BG001|Baseline|Part 1: 1000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
11058676|NCT01349049|BG002|Baseline|Part 1: 1200 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day
11058677|NCT01349049|BG003|Baseline|Part 1: 1400 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day
10887117|NCT00498797|BG001|Baseline|Placebo|docetaxel/prednisolone/placebo
10887118|NCT00498797|BG002|Baseline|Total|Total of all reporting groups
11058678|NCT01349049|BG004|Baseline|Part 1: 2000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day
11058679|NCT01349049|BG005|Baseline|Part 1: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
11058680|NCT01349049|BG006|Baseline|Part 1: 4000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day
11058681|NCT01349049|BG007|Baseline|Part 1: 5000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day
11058682|NCT01349049|BG008|Baseline|Part 2: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
11058683|NCT01349049|BG009|Baseline|Total|Total of all reporting groups
11058684|NCT01349049|FG000|Participant Flow|Part 1: 800 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day
11058685|NCT01349049|FG001|Participant Flow|Part 1: 1000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
11058686|NCT01349049|FG002|Participant Flow|Part 1: 1200 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day
11058687|NCT01349049|FG003|Participant Flow|Part 1: 1400 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
11058688|NCT01349049|FG004|Participant Flow|Part 1: 2000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
11058689|NCT01349049|FG005|Participant Flow|Part 1: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
11058690|NCT01349049|FG006|Participant Flow|Part 1: 4000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
11058691|NCT01349049|FG007|Participant Flow|Part 1: 5000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
11058692|NCT01349049|FG008|Participant Flow|Part 2: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
11058693|NCT01349049|OG000|Outcome|Part 2: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
11058694|NCT01349049|OG000|Outcome|Part 2: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
11058695|NCT01349049|OG000|Outcome|Part 1: 800 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day.
11058696|NCT01349049|OG001|Outcome|Part 1: 1000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day.
11058697|NCT01349049|OG002|Outcome|Part 1: 1200 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
11058698|NCT01349049|OG003|Outcome|Part 1: 1400 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
11058699|NCT01349049|OG004|Outcome|Part 1: 2000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
11058700|NCT01349049|OG005|Outcome|Part 1: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
11058701|NCT01349049|OG006|Outcome|Part 1: 4000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
11058702|NCT01349049|OG007|Outcome|Part 1: 5000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
11058703|NCT01349049|OG008|Outcome|Part 2: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
10847097|NCT00281671|OG001|Outcome|Nesiritide|"In this crossover pilot study, patients are randomly assigned to receive either nesiritide 0.015 mcg/kg/min or placebo IV infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.~nesiritide: nesiritide 0.015 mcg/kg/hour x 10 hours"
11058704|NCT01349049|OG000|Outcome|Part 1: 800 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day
11058705|NCT01349049|OG002|Outcome|Part 1: 1200 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day
11058706|NCT01349049|OG003|Outcome|Part 1: 1400 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day
11058707|NCT01349049|OG004|Outcome|Part 1: 2000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day
11058708|NCT01349049|OG005|Outcome|Part 1: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
11058709|NCT01349049|OG006|Outcome|Part 1: 4000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day
11058710|NCT01349049|OG007|Outcome|Part 1: 5000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day
11058711|NCT01349049|OG008|Outcome|Part 2: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
11058712|NCT01349049|OG001|Outcome|Part 1: 1000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
11058713|NCT01349049|OG006|Outcome|Part 1: 4000 mg/Day|Participants with relapsed or refractory acute myeloid leukemia (AML) who received PLX3397 4000 mg/day.
11058714|NCT01349049|EG000|Reported Event|Part 1: 800 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day.
11058715|NCT01349049|EG001|Reported Event|Part 1: 1000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day.
11058716|NCT01349049|EG002|Reported Event|Part 1: 1200 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
11058717|NCT01349049|EG003|Reported Event|Part 1: 1400 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
11058718|NCT01349049|EG004|Reported Event|Part 1: 2000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
11058719|NCT01349049|EG005|Reported Event|Part 1: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
11058720|NCT01349049|EG006|Reported Event|Part 1: 4000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
10847098|NCT00281671|EG000|Reported Event|Nesiritide|Patients received nesiritide 0.015 mcg/kg/hour for 10 hours
11058721|NCT01349049|EG007|Reported Event|Part 1: 5000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
11058722|NCT01349049|EG008|Reported Event|Part 2: 3000 mg/Day|Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
11058723|NCT01349114|BG000|Baseline|Aliskiren|aliskiren 300 mg daily
11058724|NCT01349114|BG001|Baseline|Placebo|Sugar pill/placebo
11058725|NCT01349114|BG002|Baseline|Total|Total of all reporting groups
11058726|NCT01349114|FG000|Participant Flow|Aliskiren|aliskiren 300 mg daily
11058727|NCT01349114|FG001|Participant Flow|Sugar Pill/Placebo|Sugar pill/placebo arm
11058728|NCT01349114|OG000|Outcome|Aliskiren|aliskiren 300 mg daily
11058729|NCT01349114|OG001|Outcome|Placebo|Sugar pill/ placebo
11058730|NCT01349114|OG000|Outcome|Aliskiren|"aliskiren 300 mg daily~aliskiren: aliskiren 300 mg daily"
11058731|NCT01349114|OG001|Outcome|Placebo|placebo: placebo
11058732|NCT01349114|EG000|Reported Event|Aliskiren|aliskiren 300 mg daily
11058733|NCT01349114|EG001|Reported Event|Placebo|Sugar pill/ placebo
11058734|NCT01349140|BG000|Baseline|Nerve Block|Exparel: liposome bupivacaine
11058735|NCT01349140|FG000|Participant Flow|Nerve Block|EXPAREL: active liposome bupivacaine
11058736|NCT01349140|OG000|Outcome|Nerve Block|Exparel: liposome bupivacaine
11058737|NCT01349140|EG000|Reported Event|Nerve Block|Exparel: liposome bupivacaine
11058738|NCT01349192|BG000|Baseline|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
11058739|NCT01349192|BG001|Baseline|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
11058740|NCT01349192|BG002|Baseline|Total|Total of all reporting groups
11058741|NCT01349192|FG000|Participant Flow|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
11058742|NCT01349192|FG001|Participant Flow|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
11058743|NCT01349192|OG000|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
11058744|NCT01349192|OG001|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
11058745|NCT01349192|OG000|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
11058746|NCT01349192|OG001|Outcome|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
11058747|NCT01349192|EG000|Reported Event|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
11058748|NCT01349192|EG001|Reported Event|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
11058749|NCT01349231|BG000|Baseline|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
11058750|NCT01349231|FG000|Participant Flow|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
11058751|NCT01349231|OG000|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
11058752|NCT01349231|EG000|Reported Event|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
11058753|NCT01349465|BG000|Baseline|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058754|NCT01349465|BG001|Baseline|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058755|NCT01349465|BG002|Baseline|Total|Total of all reporting groups
11058756|NCT01349465|FG000|Participant Flow|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058757|NCT01349465|FG001|Participant Flow|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058758|NCT01349465|OG000|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058759|NCT01349465|OG000|Outcome|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058760|NCT01349465|OG001|Outcome|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058761|NCT01349465|EG000|Reported Event|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058762|NCT01349465|EG001|Reported Event|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
11058763|NCT01349465|EG002|Reported Event|Total|All Enrolled Subjects
11058764|NCT01349491|BG000|Baseline|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
11058765|NCT01349491|BG001|Baseline|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
11058766|NCT01349491|BG002|Baseline|Total|Total of all reporting groups
11058767|NCT01349491|FG000|Participant Flow|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
11058768|NCT01349491|FG001|Participant Flow|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
11058769|NCT01349491|OG000|Outcome|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
11058770|NCT01349491|OG001|Outcome|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
11058771|NCT01349491|EG000|Reported Event|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
11058772|NCT01349491|EG001|Reported Event|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
11058773|NCT01349569|BG000|Baseline|Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide|"Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).~Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.~Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine."
11058774|NCT01349569|FG000|Participant Flow|Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide|"Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).~Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.~Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine."
11058775|NCT01349569|OG000|Outcome|Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide|"Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).~Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.~Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine."
11058776|NCT01349569|OG000|Outcome|Pre-vaccine (Baseline)|Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).
11058777|NCT01349569|OG001|Outcome|GVAX Vaccine|Allogeneic Myeloma Vaccine: A total of 4 doses will be administered. The first three at monthly intervals and a booster at 6 months from the initial dose. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.
11058778|NCT01349569|OG002|Outcome|Prevnar Vaccine|Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
11058779|NCT01349569|EG000|Reported Event|Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide|"Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).~Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.~Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine."
11058780|NCT01349660|BG000|Baseline|Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
11058781|NCT01349660|BG001|Baseline|Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
11058782|NCT01349660|BG002|Baseline|Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase II patients include those with progressive glioblastoma multiforme"
11058783|NCT01349660|BG003|Baseline|Total|Total of all reporting groups
11058784|NCT01349660|FG000|Participant Flow|Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
11058785|NCT01349660|FG001|Participant Flow|Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
11058786|NCT01349660|FG002|Participant Flow|Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase II patients include those with progressive glioblastoma multiforme"
11058787|NCT01349660|OG000|Outcome|Phase I Dose Level 1 (60 mg BKM120, 10mg/kg Bevacizumab)|Includes Phase I patients receiving 60 mg BKM120 and 10mg/kg bevacizumab.
11058788|NCT01349660|OG001|Outcome|Phase I Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|Includes Phase I patients receiving 80mg BKM120 and 10mg/kg bevacizumab
11058789|NCT01349660|OG000|Outcome|Phase II Patients With Prior Bevacizumab Treatment.|"Phase II patients previously treated with bevacizumab prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
11058790|NCT01349660|OG001|Outcome|Phase II Patients Without Prior Bevacizumab Treatment|"Phase II patients that had not previously been treated with bevacizumab prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
11058791|NCT01349660|OG000|Outcome|Phase II Participants - Prior Bevacizumab.|"Phase II participants treated with bevacizumab as part of first-line treatment prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
11058792|NCT01349660|OG001|Outcome|Phase II Participants - Bevacizumab Naive|"Phase II participants that have not received bevacizumab treatment prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
11058793|NCT01349660|OG000|Outcome|Phase II Participants - Prior Bevacizumab|"Phase II participants treated with bevacizumab as part of first-line treatment prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
11058794|NCT01349660|OG000|Outcome|Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
11058795|NCT01349660|OG001|Outcome|Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
11058796|NCT01349660|OG002|Outcome|Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase II patients include those with progressive glioblastoma multiforme"
11058797|NCT01349660|EG000|Reported Event|Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
11058798|NCT01349660|EG001|Reported Event|Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
11058799|NCT01349660|EG002|Reported Event|Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase II patients include those with progressive glioblastoma multiforme"
11058800|NCT01349673|BG000|Baseline|Budesonide Foam|Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
11058801|NCT01349673|FG000|Participant Flow|Budesonide Foam|Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
11058802|NCT01349673|OG000|Outcome|Budesonide Foam|Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
11058803|NCT01349673|EG000|Reported Event|Budesonide Foam|Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
11058804|NCT01349790|BG000|Baseline|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
11058805|NCT01349790|FG000|Participant Flow|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
11058806|NCT01349790|OG000|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
11058807|NCT01349790|EG000|Reported Event|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
11058808|NCT01349803|BG000|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
11058809|NCT01349803|BG001|Baseline|GP MDI (PT001)|GP MDI 36 mcg
11058810|NCT01349803|BG002|Baseline|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
11058811|NCT01349803|BG003|Baseline|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
11058812|NCT01349803|BG004|Baseline|Total|Total of all reporting groups
11058813|NCT01349803|FG000|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
11058814|NCT01349803|FG001|Participant Flow|GP MDI (PT001)|GP MDI 36 mcg
11058815|NCT01349803|FG002|Participant Flow|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
11058816|NCT01349803|FG003|Participant Flow|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
11058817|NCT01349803|OG000|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
11058818|NCT01349803|OG001|Outcome|GP MDI (PT001)|GP MDI 36 mcg
11058819|NCT01349803|OG002|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
11058820|NCT01349803|OG003|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
11058821|NCT01349803|OG000|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=59
11058822|NCT01349803|OG001|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
11058823|NCT01349803|OG002|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
11058824|NCT01349803|OG003|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
11058825|NCT01349803|OG000|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=58
11058826|NCT01349803|OG001|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=57 Day 14: N=57
11226714|NCT02377466|BG000|Baseline|Placebo|Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
11226715|NCT02377466|BG001|Baseline|Retosiban|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11226716|NCT02377466|BG002|Baseline|Total|Total of all reporting groups
11226717|NCT02377466|FG000|Participant Flow|Placebo|Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
11226718|NCT02377466|FG001|Participant Flow|Retosiban|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11226719|NCT02377466|OG000|Outcome|Placebo|Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
11226720|NCT02377466|OG001|Outcome|Retosiban|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11058827|NCT01349803|OG002|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=55 Day 14: N=55
11058828|NCT01349803|OG000|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
11058829|NCT01349803|EG000|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
11058830|NCT01349803|EG001|Reported Event|GP MDI (PT001)|GP MDI 36 mcg
11058831|NCT01349803|EG002|Reported Event|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
11058832|NCT01349803|EG003|Reported Event|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
11058833|NCT01349816|BG000|Baseline|Overall Study|All patients randomized and treated
11058834|NCT01349816|FG000|Participant Flow|Overall Study|Overall Study
11058835|NCT01349816|OG000|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
11058836|NCT01349816|OG001|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
11058837|NCT01349816|OG002|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
11058838|NCT01349816|OG003|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
11058839|NCT01349816|OG004|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
11058840|NCT01349816|OG005|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
11058841|NCT01349816|EG000|Reported Event|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
11058842|NCT01349816|EG001|Reported Event|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
11058843|NCT01349816|EG002|Reported Event|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
11058844|NCT01349816|EG003|Reported Event|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
11058845|NCT01349816|EG004|Reported Event|GP MDI 36 µg|GP MDI 36 µg BID
11058846|NCT01349816|EG005|Reported Event|FF MDI 9.6 µg|FF MDI 9.6 µg BID
11066824|NCT01393990|OG006|Outcome|Part A: 160 mg LY2228820 Capsules|160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066825|NCT01393990|OG007|Outcome|Part A: 200 mg LY2228820 Capsules|200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066826|NCT01393990|OG008|Outcome|Part A: 160 mg LY2228820 Bridge|In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
11066827|NCT01393990|OG009|Outcome|Part A: 160 mg LY2228820 Tablets|160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066828|NCT01393990|OG010|Outcome|Part A: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11226721|NCT02377466|OG001|Outcome|Retosiban|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period
11226722|NCT02377466|OG000|Outcome|Placebo|Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, intravenous (IV) loading dose over 5 minutes and continuous infusion rate for remainder of 48-hour treatment period.Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
11058847|NCT01349829|BG000|Baseline|HAVpur|
11058848|NCT01349829|BG001|Baseline|Havrix|
11058849|NCT01349829|BG002|Baseline|Total|Total of all reporting groups
11058850|NCT01349829|FG000|Participant Flow|HAVpur|
11058851|NCT01349829|FG001|Participant Flow|Havrix|
11058852|NCT01349829|OG000|Outcome|HAVpur|
11058853|NCT01349829|OG001|Outcome|Havrix|
11058854|NCT01349829|EG000|Reported Event|HAVpur - First Vaccination|
11058855|NCT01349829|EG001|Reported Event|Havrix - First Vaccination|
11058856|NCT01349829|EG002|Reported Event|HAVPur - Second Vaccination|
11058857|NCT01349829|EG003|Reported Event|Havrix - Second Vaccination|
11058858|NCT01349920|BG000|Baseline|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
11058859|NCT01349920|FG000|Participant Flow|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
11058860|NCT01349920|OG000|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
11058861|NCT01349920|EG000|Reported Event|Pre-study|From 4 weeks prior to first dose, up to first dose of infliximab
11058862|NCT01349920|EG001|Reported Event|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
11058863|NCT01349920|EG002|Reported Event|Post-study|From last dose of study drug, up to 24 days after last dose of infliximab
11058864|NCT01349933|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
11058865|NCT01349933|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
11058866|NCT01349933|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
11058867|NCT01349933|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206: Given PO
11058868|NCT01349972|BG000|Baseline|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
11058869|NCT01349972|BG001|Baseline|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
11058870|NCT01349972|BG002|Baseline|Total|Total of all reporting groups
11058871|NCT01349972|FG000|Participant Flow|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
11058872|NCT01349972|FG001|Participant Flow|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
11058873|NCT01349972|OG000|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
11058874|NCT01349972|OG001|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
11058875|NCT01349972|EG000|Reported Event|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
11058876|NCT01349972|EG001|Reported Event|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
11058877|NCT01350102|BG000|Baseline|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
11066829|NCT01393990|OG011|Outcome|Part A: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11058878|NCT01350102|BG001|Baseline|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
11058879|NCT01350102|BG002|Baseline|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
11058880|NCT01350102|BG003|Baseline|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
11058881|NCT01350102|BG004|Baseline|Total|Total of all reporting groups
11058882|NCT01350102|FG000|Participant Flow|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
11058883|NCT01350102|FG001|Participant Flow|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
11058884|NCT01350102|FG002|Participant Flow|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
11058885|NCT01350102|FG003|Participant Flow|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
11058886|NCT01350102|OG000|Outcome|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
11058887|NCT01350102|OG001|Outcome|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
11058888|NCT01350102|OG002|Outcome|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
11058889|NCT01350102|OG003|Outcome|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
11058890|NCT01350102|EG000|Reported Event|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
11058891|NCT01350102|EG001|Reported Event|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
11058892|NCT01350102|EG002|Reported Event|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
11058893|NCT01350102|EG003|Reported Event|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
11058894|NCT01350115|BG000|Baseline|LDE225|Participants received 400 mg once daily.
10847099|NCT00281671|EG001|Reported Event|Placebo|Patients assigned to this arm received a placebo infusion (0.9 normal saline) for 10 hours
10887119|NCT00498797|FG000|Participant Flow|Vandetanib|docetaxel/prednisolone/vandetanib
11058895|NCT01350115|BG001|Baseline|Placebo|Participants received matching placebo.
11058896|NCT01350115|BG002|Baseline|Total|Total of all reporting groups
11058897|NCT01350115|FG000|Participant Flow|LDE225|Participants received 400 mg once daily.
11058898|NCT01350115|FG001|Participant Flow|Placebo|Participants received matching placebo.
11058899|NCT01350115|OG000|Outcome|LDE225|Participants received 400 mg once daily.
11058900|NCT01350115|OG001|Outcome|Placebo|Participants received matching placebo.
11058901|NCT01350115|EG000|Reported Event|LDE225 - Core|Participants received 400 mg once daily.
11058902|NCT01350115|EG001|Reported Event|Placebo - Core|Participants received matching placebo.
11058903|NCT01350115|EG002|Reported Event|LDE225 - Long Term Follow-up|
11058904|NCT01350115|EG003|Reported Event|Placebo - Long Term Follow-up|
11226723|NCT02377466|OG000|Outcome|Retosiban|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11226724|NCT02377466|EG000|Reported Event|Placebo (Maternal)|Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
11226725|NCT02377466|EG001|Reported Event|Retosiban (Maternal)|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11058905|NCT01350128|BG000|Baseline|ITT Population|ITT Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.
11058906|NCT01350128|FG000|Participant Flow|All Subjects Randomized|
11058907|NCT01350128|OG000|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
11058908|NCT01350128|OG001|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
11058909|NCT01350128|OG002|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
11058910|NCT01350128|OG003|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
11058911|NCT01350128|OG004|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
11058912|NCT01350128|OG005|Outcome|Placebo MDI BID|Placebo MDI BID.
11058913|NCT01350128|EG000|Reported Event|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
11058914|NCT01350128|EG001|Reported Event|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
11058915|NCT01350128|EG002|Reported Event|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
11058916|NCT01350128|EG003|Reported Event|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
11058917|NCT01350128|EG004|Reported Event|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
11058918|NCT01350128|EG005|Reported Event|Placebo BID|Placebo BID.
11058919|NCT01350141|BG000|Baseline|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058920|NCT01350141|BG001|Baseline|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058921|NCT01350141|BG002|Baseline|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058922|NCT01350141|BG003|Baseline|Total|Total of all reporting groups
11058923|NCT01350141|FG000|Participant Flow|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058924|NCT01350141|FG001|Participant Flow|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058925|NCT01350141|FG002|Participant Flow|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058926|NCT01350141|OG000|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058927|NCT01350141|OG001|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058928|NCT01350141|OG002|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058929|NCT01350141|OG000|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058930|NCT01350141|OG001|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058931|NCT01350141|EG000|Reported Event|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058932|NCT01350141|EG001|Reported Event|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058933|NCT01350141|EG002|Reported Event|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
11058934|NCT01350245|BG000|Baseline|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
11058935|NCT01350245|FG000|Participant Flow|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
11058936|NCT01350245|OG000|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
11058937|NCT01350245|EG000|Reported Event|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
11058938|NCT01350271|BG000|Baseline|Placebo|Hookworm positive participants randomized to placebo
11058939|NCT01350271|BG001|Baseline|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
11058940|NCT01350271|BG002|Baseline|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
11058941|NCT01350271|BG003|Baseline|Total|Total of all reporting groups
11058942|NCT01350271|FG000|Participant Flow|Placebo|70 were allocated to this arm and 49 were followed up in the post treatment.
11058943|NCT01350271|FG001|Participant Flow|Mebendazole Polymorph A and C 500 mg|70 were allocated and 53 were followed up in the post treatment.
11058944|NCT01350271|FG002|Participant Flow|Mebendazole Polymorph C 500 mg|74 were allocated and 48 were followed up in the post treatment.
11058945|NCT01350271|OG000|Outcome|Placebo|Hookworm infected individual randomized to placebo
11058946|NCT01350271|OG001|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph A and C 500 mg
11058947|NCT01350271|OG002|Outcome|Mebendazole Polymorph C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph C 500 mg
11058948|NCT01350271|OG000|Outcome|Placebo|Hookworm positive participants randomized to placebo
11226726|NCT02377466|EG002|Reported Event|Placebo (Fetal)|Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
10887120|NCT00498797|FG001|Participant Flow|Placebo|docetaxel/prednisolone/placebo
11058949|NCT01350271|OG001|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
11058950|NCT01350271|OG002|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
11058951|NCT01350271|EG000|Reported Event|Placebo|Hookworm positive participants randomized to placebo
11058952|NCT01350271|EG001|Reported Event|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
11226727|NCT02377466|EG003|Reported Event|Retosiban (Fetal)|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11058953|NCT01350271|EG002|Reported Event|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
11058954|NCT01350336|BG000|Baseline|Alair|"Alair system~Alair System: Treatment of airways with the Alair System"
11058955|NCT01350336|FG000|Participant Flow|Alair|Participants consented for treatment with Alair
11058956|NCT01350336|OG000|Outcome|Year 1|Proportion of Severe Exacerbations at Year 1
11058957|NCT01350336|OG001|Outcome|Year 2|Proportion of Severe Exacerbations at Year 2
11058958|NCT01350336|OG002|Outcome|Year 3|Proportion of Severe Exacerbations at Year 3
11058959|NCT01350336|OG003|Outcome|Year 4|Proportion of Severe Exacerbations at Year 4
11058960|NCT01350336|OG004|Outcome|Year 5|Proportion of Severe Exacerbations at Year 5
11058961|NCT01350336|OG000|Outcome|Year 1|Rates of Severe Exacerbations at Year 1
11058962|NCT01350336|OG001|Outcome|Year 2|Rates of Severe Exacerbations at Year 2
11058963|NCT01350336|OG002|Outcome|Year 3|Rates of Severe Exacerbations at Year 3
11058964|NCT01350336|OG003|Outcome|Year 4|Rates of Severe Exacerbations at Year 4
11058965|NCT01350336|OG004|Outcome|Year 5|Rates of Severe Exacerbations at Year 5
11058966|NCT01350336|OG000|Outcome|Year 1|Respiratory adverse events at Year 1
11058967|NCT01350336|OG001|Outcome|Year 2|Respiratory adverse events at Year 2
11058968|NCT01350336|OG002|Outcome|Year 3|Respiratory adverse events at Year 3
11058969|NCT01350336|OG003|Outcome|Year 4|Respiratory adverse events at Year 4
11058970|NCT01350336|OG004|Outcome|Year 5|Respiratory adverse events at Year
11058971|NCT01350336|OG004|Outcome|Year 5|Respiratory adverse events at Year 5
11058972|NCT01350336|OG000|Outcome|Year 1|Emergency room visits for respiratory symptoms rates at Year 1
11058973|NCT01350336|OG001|Outcome|Year 2|Emergency room visits for respiratory symptoms rates at Year 2
11058974|NCT01350336|OG002|Outcome|Year 3|Emergency room visits for respiratory symptoms rates at Year 3
11058975|NCT01350336|OG003|Outcome|Year 4|Emergency room visits for respiratory symptoms rates at Year 4
11058976|NCT01350336|OG004|Outcome|Year 5|Emergency room visits for respiratory symptoms rates at Year 5
11058977|NCT01350336|OG000|Outcome|Year 1|Emergency room visits for respiratory symptoms proportions at Year 1
10887121|NCT00498797|OG000|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
11058978|NCT01350336|OG001|Outcome|Year 2|Emergency room visits for respiratory symptoms proportions at Year 2
11058979|NCT01350336|OG002|Outcome|Year 3|Emergency room visits for respiratory symptoms proportions at Year 3
11058980|NCT01350336|OG003|Outcome|Year 4|Emergency room visits for respiratory symptoms proportions at Year 4
11058981|NCT01350336|OG004|Outcome|Year 5|Emergency room visits for respiratory symptoms proportions at Year 5
11058982|NCT01350336|OG000|Outcome|Year 1|Hospitalizations for respiratory symptoms rates at Year 1
11058983|NCT01350336|OG001|Outcome|Year 2|Hospitalizations for respiratory symptoms rates at Year 2
11058984|NCT01350336|OG002|Outcome|Year 3|Hospitalizations for respiratory symptoms rates at Year 3
11058985|NCT01350336|OG003|Outcome|Year 4|Hospitalizations for respiratory symptoms rates at Year 4
11058986|NCT01350336|OG004|Outcome|Year 5|Hospitalizations for respiratory symptoms rates at Year 5
11058987|NCT01350336|OG000|Outcome|Year 1|Hospitalizations for respiratory symptoms proportions at Year 1
11058988|NCT01350336|OG001|Outcome|Year 2|Hospitalizations for respiratory symptoms proportions at Year 2
11058989|NCT01350336|OG002|Outcome|Year 3|Hospitalizations for respiratory symptoms proportions at Year 3
11058990|NCT01350336|OG003|Outcome|Year 4|Hospitalizations for respiratory symptoms proportions at Year 4
11058991|NCT01350336|OG004|Outcome|Year 5|Hospitalizations for respiratory symptoms proportions at Year 5
11058992|NCT01350336|OG000|Outcome|Year 1|Respiratory Serious Adverse Events rates at Year 1
11058993|NCT01350336|OG001|Outcome|Year 2|Respiratory Serious Adverse Events rates at Year 2
11058994|NCT01350336|OG002|Outcome|Year 3|Respiratory Serious Adverse Events rates at Year 3
11058995|NCT01350336|OG003|Outcome|Year 4|Respiratory Serious Adverse Events rates at Year 4
11058996|NCT01350336|OG004|Outcome|Year 5|Respiratory Serious Adverse Events rates at Year 5
11058997|NCT01350336|OG000|Outcome|Year 1|Respiratory Serious Adverse Events proportions at Year 1
11058998|NCT01350336|OG001|Outcome|Year 2|Respiratory Serious Adverse Events proportions at Year 2
11058999|NCT01350336|OG002|Outcome|Year 3|Respiratory Serious Adverse Events proportions at Year 3
11059000|NCT01350336|OG003|Outcome|Year 4|Respiratory Serious Adverse Events proportions at Year 4
11059001|NCT01350336|OG004|Outcome|Year 5|Respiratory Serious Adverse Events proportions at Year 5
11059002|NCT01350336|EG000|Reported Event|Alair|"Alair system~Alair System: Treatment of airways with the Alair System"
11059003|NCT01350388|BG000|Baseline|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
11059004|NCT01350388|BG001|Baseline|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
11059005|NCT01350388|BG002|Baseline|Total|Total of all reporting groups
11059006|NCT01350388|FG000|Participant Flow|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
11059007|NCT01350388|FG001|Participant Flow|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
11059008|NCT01350388|OG000|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
11059009|NCT01350388|OG001|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
11059010|NCT01350388|EG000|Reported Event|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
11059011|NCT01350388|EG001|Reported Event|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
11059012|NCT01350401|BG000|Baseline|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
11059013|NCT01350401|FG000|Participant Flow|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
11059014|NCT01350401|OG000|Outcome|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
11059015|NCT01350401|OG000|Outcome|Subject 1 - Manufactured Product|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
11059016|NCT01350401|OG001|Outcome|Subject 1 - Day 60|
11059017|NCT01350401|OG002|Outcome|Subject 2 - Manufactured Product|
11059018|NCT01350401|OG003|Outcome|Subject 2 - Day 60|
11059019|NCT01350401|EG000|Reported Event|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
11059020|NCT01350414|BG000|Baseline|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02, NCT00231114).
11059021|NCT01350414|FG000|Participant Flow|Alair Group|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02)~Bronchial Thermoplasty with the Alair System: Bronchial Thermoplasty with the Alair System"
11059022|NCT01350414|OG000|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
11059023|NCT01350414|OG000|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
11059024|NCT01350414|OG000|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol Number 04-02, NCT00231114).
11059025|NCT01350414|EG000|Reported Event|Year 1|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 1 is defined as 365 days from the treatment period (6 weeks after the last bronchoscopy). All subjects were considered in the analysis regardless of whether they have completed the Year 1 annual visit or not."
11059026|NCT01350414|EG001|Reported Event|Year 2|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 2 is defined as 366 to 730 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 2 annual visit or not."
11059027|NCT01350414|EG002|Reported Event|Year 3|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 3 is defined as 731 to 1095 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 3 annual visit or not."
11059028|NCT01350414|EG003|Reported Event|Year 4|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 4 is defined as 1096 to 1460 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 4 annual visit or not."
11059029|NCT01350414|EG004|Reported Event|Year 5|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 5 is defined as 1461 days to 1826 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 5 annual visit or not."
11059030|NCT01350453|BG000|Baseline|LifeCIT|"Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.~LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities."
11059031|NCT01350453|BG001|Baseline|Standard Care|Standard Care: Participants will receive their usual care from their NHS provider.
11059032|NCT01350453|BG002|Baseline|Total|Total of all reporting groups
11059033|NCT01350453|FG000|Participant Flow|LifeCIT|"Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.~LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities."
11059034|NCT01350453|FG001|Participant Flow|Standard Care|Standard Care: Participants will receive their usual care from their NHS provider.
11059035|NCT01350453|OG000|Outcome|LifeCIT|"Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.~LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities."
11059036|NCT01350453|OG001|Outcome|Standard Care|Standard Care: Participants will receive their usual care from their NHS provider.
11059037|NCT01350453|OG000|Outcome|LifeCIT|
11059038|NCT01350453|OG001|Outcome|Usual Care|
11059039|NCT01350453|EG000|Reported Event|LifeCIT|"Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.~LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities."
11059040|NCT01350453|EG001|Reported Event|Standard Care|Standard Care: Participants will receive their usual care from their NHS provider.
11059041|NCT01350479|BG000|Baseline|MRSA Colonized|Residents colonized with MRSA by culture at study admission
11059042|NCT01350479|BG001|Baseline|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
11059043|NCT01350479|BG002|Baseline|Total|Total of all reporting groups
11059044|NCT01350479|FG000|Participant Flow|MRSA Colonized|Residents colonized with MRSA by culture at study admission
11059045|NCT01350479|FG001|Participant Flow|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
11059046|NCT01350479|OG000|Outcome|Swabs From Interactions With MRSA Colonized Residents|Swabs collected from healthcare workers interacting with residents colonized with MRSA by culture on enrollment
11059047|NCT01350479|OG001|Outcome|Swabs From Interactions With Not MRSA Colonized Residents|Swabs collected from healthcare workers interacting with residents not colonized with MRSA by culture on enrollment
11059048|NCT01350479|EG000|Reported Event|MRSA Colonized|Residents colonized with MRSA by culture at study admission
11059049|NCT01350479|EG001|Reported Event|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
11059050|NCT01350492|BG000|Baseline|Resistance Exercise Training|Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
11059051|NCT01350492|BG001|Baseline|Waitlist Control|Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
11059052|NCT01350492|BG002|Baseline|Total|Total of all reporting groups
11059053|NCT01350492|FG000|Participant Flow|Resistance Exercise Training|Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
11059054|NCT01350492|FG001|Participant Flow|Waitlist Control|Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
11059055|NCT01350492|OG000|Outcome|Resistance Exercise Training|Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
11059056|NCT01350492|OG001|Outcome|Waitlist Control|Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
11059057|NCT01350492|EG000|Reported Event|Resistance Exercise Training|Resistance Exercise Training: 16 weeks of resistance exercise training, performed twice weekly, for the treatment of chronic muscle pain.
11059058|NCT01350492|EG001|Reported Event|Waitlist Control|Waitlist Control: Individuals assigned to this condition were asked to maintain their usual routine while enrolled. Upon completion they were offered the opportunity to undertake the resistance training protocol.
11059059|NCT01350505|BG000|Baseline|Light Exposure|13 minutes of experimental light exposure during the night
11059060|NCT01350505|FG000|Participant Flow|Light Exposure|13 minutes of experimental light exposure during the night
11059061|NCT01350505|OG000|Outcome|Light Exposure|13 minutes of experimental light exposure during the night
11059062|NCT01350505|EG000|Reported Event|Light Exposure|13 minutes of experimental light exposure during the night
11059063|NCT01350544|BG000|Baseline|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
11059064|NCT01350544|BG001|Baseline|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
11059065|NCT01350544|BG002|Baseline|Total|Total of all reporting groups
11059066|NCT01350544|FG000|Participant Flow|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
11059067|NCT01350544|FG001|Participant Flow|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
11059068|NCT01350544|OG000|Outcome|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
11059069|NCT01350544|OG001|Outcome|Treatment Advocacy|Treatment Advocacy: Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, all participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary. This description is subject to change after consideration by the community advisory board.
11059070|NCT01350544|EG000|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
11066830|NCT01393990|OG012|Outcome|Part A: 420 mg LY2228820 Tablets|420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066831|NCT01393990|OG013|Outcome|Part A: 560 mg LY2228820 Tablets|560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11059071|NCT01350544|EG001|Reported Event|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
11059072|NCT01350804|BG000|Baseline|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
11059073|NCT01350804|BG001|Baseline|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
11059074|NCT01350804|BG002|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
11059075|NCT01350804|BG003|Baseline|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
11059076|NCT01350804|BG004|Baseline|Total|Total of all reporting groups
11059077|NCT01350804|FG000|Participant Flow|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
11059078|NCT01350804|FG001|Participant Flow|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
11059079|NCT01350804|FG002|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
11059080|NCT01350804|FG003|Participant Flow|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
11059081|NCT01350804|OG000|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
11059082|NCT01350804|OG001|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
11059083|NCT01350804|OG002|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
11059084|NCT01350804|OG003|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
11226728|NCT02377466|EG004|Reported Event|Placebo (Neonatal)|Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
11059085|NCT01350804|OG004|Outcome|Placebo Non-responder - AIN457 75 mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
11226729|NCT02377466|EG005|Reported Event|Retosiban (Neonatal)|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11059086|NCT01350804|OG005|Outcome|Placebo Non-responder - AIN457 150 mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
11059087|NCT01350804|OG006|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
11059088|NCT01350804|OG007|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
11059089|NCT01350804|OG008|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
11059090|NCT01350804|OG009|Outcome|Abatacept Non-respnders - AIN457 75mg|Participants switched from abatacept to AIN457 75 mg starting at week 24.
11059091|NCT01350804|OG010|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
11059092|NCT01350804|OG004|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
11059093|NCT01350804|OG005|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
11059094|NCT01350804|OG009|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
11059095|NCT01350804|EG000|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg
11059096|NCT01350804|EG001|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
11059097|NCT01350804|EG002|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
11059098|NCT01350804|EG003|Reported Event|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
11066832|NCT01393990|OG014|Outcome|Part B: 420 mg LY2228820 Tablets|420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
11059099|NCT01350947|BG000|Baseline|All Patients|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
11059100|NCT01350947|FG000|Participant Flow|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
11059101|NCT01350947|OG000|Outcome|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
11059102|NCT01350947|EG000|Reported Event|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
11059103|NCT01350973|BG000|Baseline|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
11059104|NCT01350973|BG001|Baseline|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
11059105|NCT01350973|BG002|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
11059106|NCT01350973|BG003|Baseline|Total|Total of all reporting groups
11059107|NCT01350973|FG000|Participant Flow|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
11059108|NCT01350973|FG001|Participant Flow|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
11059109|NCT01350973|FG002|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
11059110|NCT01350973|OG000|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
11059111|NCT01350973|OG001|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
11059112|NCT01350973|OG002|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
11059113|NCT01350973|EG000|Reported Event|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
11059114|NCT01350973|EG001|Reported Event|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
11059115|NCT01350973|EG002|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
11059116|NCT01350999|BG000|Baseline|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
11226730|NCT02377674|BG000|Baseline|Vascular Graft, Model COR-VG-001|"A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.~Vascular Graft, Model COR-VG-001: The intended use of the Xeltis Vascular Graft, Model COR-VG-001 is to create an extracardiac total cavopulmonary connection (EC-TCPC) connection to divert the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle reducing the volume load on the functional single ventricle and thereby improving hemodynamics by minimizing the deleterious effects of ventricular hypertrophy."
11059117|NCT01350999|BG001|Baseline|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
11059118|NCT01350999|BG002|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
11059119|NCT01350999|BG003|Baseline|Total|Total of all reporting groups
11059120|NCT01350999|FG000|Participant Flow|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
11059121|NCT01350999|FG001|Participant Flow|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
11059122|NCT01350999|FG002|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
11059123|NCT01350999|OG000|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
11059124|NCT01350999|OG001|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
11059125|NCT01350999|OG002|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
11059126|NCT01350999|EG000|Reported Event|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
11059127|NCT01350999|EG001|Reported Event|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
11059128|NCT01350999|EG002|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
11059129|NCT01351025|BG000|Baseline|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
11059130|NCT01351025|BG001|Baseline|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
11059131|NCT01351025|BG002|Baseline|Total|Total of all reporting groups
11059132|NCT01351025|FG000|Participant Flow|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
11059133|NCT01351025|FG001|Participant Flow|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
11059134|NCT01351025|OG000|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
11059135|NCT01351025|OG001|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
11059136|NCT01351025|OG000|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
11059137|NCT01351025|OG001|Outcome|Arm B: Placebo / Atorvastatin|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
11059138|NCT01351025|OG000|Outcome|Arm A: Atorvastatin / Placebo|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
11059139|NCT01351025|OG001|Outcome|Arm B: Placebo / Atorvastatin|"At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
11059140|NCT01351025|EG000|Reported Event|Arm A: Atorvastatin / Placebo Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
11059141|NCT01351025|EG001|Reported Event|Arm B: Placebo / Atorvastatin Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
10887122|NCT00498797|OG001|Outcome|Placebo|docetaxel/prednisolone/placebo
10887123|NCT00498797|EG000|Reported Event|Vandetanib|docetaxel/prednisolone/vandetanib
11059142|NCT01351025|EG002|Reported Event|Arm A: Atorvastatin / Placebo After Cross-over (Week 24 - 48)|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
11059143|NCT01351025|EG003|Reported Event|Arm B: Placebo / Atorvastatin After Cross-over (Week 24 - 48)|At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
11059144|NCT01351064|BG000|Baseline|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
11059145|NCT01351064|BG001|Baseline|CHICA ADHD Control|This arm received CHICA without the ADHD module
11059146|NCT01351064|BG002|Baseline|Total|Total of all reporting groups
11059147|NCT01351064|FG000|Participant Flow|CHICA ADHD Module|"This arm received The Child Health Improvement through Computer Automation (CHICA) Attention Deficit Hyperactivity Disorder (ADHD) Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
11059148|NCT01351064|FG001|Participant Flow|CHICA ADHD Control|This arm received CHICA without the ADHD module
11059149|NCT01351064|OG000|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
11059150|NCT01351064|OG001|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
11059151|NCT01351064|EG000|Reported Event|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
11059152|NCT01351064|EG001|Reported Event|CHICA ADHD Control|This arm received CHICA without the ADHD module
11059153|NCT01351077|BG000|Baseline|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
11059154|NCT01351077|BG001|Baseline|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
11059155|NCT01351077|BG002|Baseline|Total|Total of all reporting groups
11341972|NCT03694210|OG000|Outcome|EndoRotor Therapy|"Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.~EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis."
11059156|NCT01351077|FG000|Participant Flow|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
11059157|NCT01351077|FG001|Participant Flow|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
11059158|NCT01351077|OG000|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
11059159|NCT01351077|OG001|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
11059160|NCT01351077|EG000|Reported Event|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
11059161|NCT01351077|EG001|Reported Event|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
11059162|NCT01351090|BG000|Baseline|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
11059163|NCT01351090|BG001|Baseline|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
11059164|NCT01351090|BG002|Baseline|Placebo Vehicle IN|Intranasal placebo
11059165|NCT01351090|BG003|Baseline|Total|Total of all reporting groups
11059166|NCT01351090|FG000|Participant Flow|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
11059167|NCT01351090|FG001|Participant Flow|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
11059168|NCT01351090|FG002|Participant Flow|Placebo Vehicle IN|Intranasal placebo
11059169|NCT01351090|OG000|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
11059170|NCT01351090|OG001|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
11059171|NCT01351090|OG002|Outcome|Placebo Vehicle IN|Intranasal placebo
11059172|NCT01351090|EG000|Reported Event|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
11059173|NCT01351090|EG001|Reported Event|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
11059174|NCT01351090|EG002|Reported Event|Placebo Vehicle IN|Intranasal placebo
11059175|NCT01351337|BG000|Baseline|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
11059176|NCT01351337|FG000|Participant Flow|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography~All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
11059177|NCT01351337|OG000|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
11059178|NCT01351337|OG000|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography~All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
11059179|NCT01351337|EG000|Reported Event|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
11059180|NCT01351350|BG000|Baseline|MLN0128P 30 or 40 mg QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).
11059181|NCT01351350|BG001|Baseline|MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).
11059182|NCT01351350|BG002|Baseline|MLN0128P 7 mg QD×5d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
11059183|NCT01351350|BG003|Baseline|Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-|MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).
11059184|NCT01351350|BG004|Baseline|Expansion Cohort MLN0128PH 8mg QDx3d QW HER2+ Plus Trastuzumab|MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).
11059185|NCT01351350|BG005|Baseline|Total|Total of all reporting groups
11059186|NCT01351350|FG000|Participant Flow|MLN0128P 30 or 40 mg QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).
11059187|NCT01351350|FG001|Participant Flow|MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).
11059188|NCT01351350|FG002|Participant Flow|MLN0128P 7 mg QD×5d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
11059189|NCT01351350|FG003|Participant Flow|Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-|MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).
11059190|NCT01351350|FG004|Participant Flow|Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab|MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).
11059191|NCT01351350|OG000|Outcome|Dose Escalation|Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m^2) on Days 1, 8, and 15 of Cycle 1.
11059192|NCT01351350|OG000|Outcome|MLN0128P 30 mg QW|MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059193|NCT01351350|OG001|Outcome|MLN0128P 40 mg QW|MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059194|NCT01351350|OG002|Outcome|MLN0128P 6 mg QD×3d QW|MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059195|NCT01351350|OG003|Outcome|MLN0128P 7 mg QD×3d QW|MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059196|NCT01351350|OG004|Outcome|MLN0128P 8 mg QD×3d QW|MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059197|NCT01351350|OG005|Outcome|MLN0128P 9 mg QD×3d QW|MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059198|NCT01351350|OG006|Outcome|MLN0128P 10 mg QD×3d QW|MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059199|NCT01351350|OG007|Outcome|MLN0128P 7 mg QD×5d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
11059200|NCT01351350|OG000|Outcome|MLN0128P 30 or 40 mg QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).
11059201|NCT01351350|OG001|Outcome|MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).
10887124|NCT00498797|EG001|Reported Event|Placebo|docetaxel/prednisolone/placebo
11059202|NCT01351350|OG002|Outcome|MLN0128P 7 mg QD×5d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
11059203|NCT01351350|OG003|Outcome|Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-|MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).
11059204|NCT01351350|OG004|Outcome|Expansion Cohort MLN0128PH 8mg QDx3d QW HER2+ Plus Trastuzumab|MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).
11059205|NCT01351350|OG000|Outcome|MLN0128P 6 mg QD×3d QW|MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059206|NCT01351350|OG001|Outcome|MLN0128P 7 mg QD×3d QW|MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059207|NCT01351350|OG002|Outcome|MLN0128P 9 mg QD×3d QW|MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059208|NCT01351350|OG003|Outcome|MLN0128P 10 mg QD×3d QW|MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.
11059209|NCT01351350|EG000|Reported Event|MLN0128P 30 or 40 mg QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).
11059210|NCT01351350|EG001|Reported Event|MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).
11059211|NCT01351350|EG002|Reported Event|MLN0128P 7 mg QD×5d QW|MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
11059212|NCT01351350|EG003|Reported Event|Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-|MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).
11059213|NCT01351350|EG004|Reported Event|Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab|MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).
11059214|NCT01351376|BG000|Baseline|Placebo|"CDT + inactive LLL~Low Level Laser Therapy: Placebo LLL combined with CDT"
11059215|NCT01351376|BG001|Baseline|LLL Combined With CDT|"CDT + active LLL~Low Level Laser: Active LLL combined with CDT"
11059216|NCT01351376|BG002|Baseline|Total|Total of all reporting groups
11059217|NCT01351376|FG000|Participant Flow|Placebo|"CDT + inactive LLL~Low Level Laser Therapy: Placebo LLL combined with CDT"
11059218|NCT01351376|FG001|Participant Flow|LLL Combined With CDT|"CDT + active LLL~Low Level Laser: Active LLL combined with CDT"
11059219|NCT01351376|OG000|Outcome|Placebo|"CDT + inactive LLL~Low Level Laser Therapy: Placebo LLL combined with CDT"
11059220|NCT01351376|OG001|Outcome|LLL Combined With CDT|"CDT + active LLL~Low Level Laser: Active LLL combined with CDT"
11059221|NCT01351376|EG000|Reported Event|Placebo|"CDT + inactive LLL~Low Level Laser Therapy: Placebo LLL combined with CDT"
11341973|NCT03694210|OG000|Outcome|Baseline SF-36v1 Score|Baseline SF-36v1 results for 8 domains
11059222|NCT01351376|EG001|Reported Event|LLL Combined With CDT|"CDT + active LLL~Low Level Laser: Active LLL combined with CDT"
11059223|NCT01351415|BG000|Baseline|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
11059224|NCT01351415|BG001|Baseline|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
11059225|NCT01351415|BG002|Baseline|Total|Total of all reporting groups
11059226|NCT01351415|FG000|Participant Flow|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
11059227|NCT01351415|FG001|Participant Flow|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
11341974|NCT03694210|OG001|Outcome|21 Day Post Necrosectomy SF-36v1 Score|21 Day Post Necrosectomy SF-36v1 results for 8 domains
11341975|NCT03694210|EG000|Reported Event|EndoRotor Therapy|"Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.~EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis."
11059228|NCT01351415|OG000|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
11059229|NCT01351415|OG001|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
11059230|NCT01351415|EG000|Reported Event|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
11059231|NCT01351415|EG001|Reported Event|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
11059232|NCT01351480|BG000|Baseline|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
11059233|NCT01351480|FG000|Participant Flow|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
11059234|NCT01351480|OG000|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
11059235|NCT01351480|EG000|Reported Event|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
11059236|NCT01351506|BG000|Baseline|ICU Survivors|Patients who survivors from ICU discharge status
11059237|NCT01351506|BG001|Baseline|ICU Non Survivors|Patients who non survivors from ICU discharge status
11059238|NCT01351506|BG002|Baseline|Total|Total of all reporting groups
11059239|NCT01351506|FG000|Participant Flow|Cohort Patient|A total of 602 patients as inclusion criteria between May 2011 and August 2012 were enrolled on the ICU admission (day 0). One hundred thirty seven patients were excluded due to a short stay in ICU or were not weighed a second time on day 1. The remainder of 465 patients were included and followed in this study.
11059240|NCT01351506|OG000|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
11059241|NCT01351506|OG001|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
11059242|NCT01351506|EG000|Reported Event|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
11059243|NCT01351506|EG001|Reported Event|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
11059244|NCT01351623|BG000|Baseline|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
11059245|NCT01351623|FG000|Participant Flow|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
11059246|NCT01351623|OG000|Outcome|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
11059247|NCT01351623|EG000|Reported Event|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
11059248|NCT01351740|BG000|Baseline|Switch|Switch to atazanavir 400 mg daily
11059249|NCT01351740|BG001|Baseline|Continuation|Remain on atazanavir/ritonavir 300mg/100 mg daily
11059250|NCT01351740|BG002|Baseline|Total|Total of all reporting groups
11059251|NCT01351740|FG000|Participant Flow|Switch|"switch to unboosted atazanavir 400mg daily with the same nucleoside (NRTI) backbone~atazanavir: switch to unboosted atazanavir 400 mg daily"
11059252|NCT01351740|FG001|Participant Flow|Continuation|"continue on current regimen of atazanavir/ritonavir 300mg/100mg with the same nucleoside (NRTI) backbone~atazanavir/ritonavir: Continue current regimen of atazanavir 300 mg/ ritonavir 100 mg daily"
11059253|NCT01351740|OG000|Outcome|Switch|Switch to atazanavir 400 mg daily
11059254|NCT01351740|OG001|Outcome|Continuation|Remain on atazanavir/ritonavir 300mg/100mg daily
11059255|NCT01351740|OG001|Outcome|Continuation|Remain on atazanavir/ritonavir 300mg/100mg
11059256|NCT01351740|EG000|Reported Event|Switch|Switch to atazanavir 400 mg daily
11059257|NCT01351740|EG001|Reported Event|Continuation|Remain on atazanavir/ritonavir 300 mg/100 mg daily
11059258|NCT01351753|BG000|Baseline|Metformin|Metformin only
11059259|NCT01351753|BG001|Baseline|Metformin + Orlistat|"Metformin~Orlistat"
11059260|NCT01351753|BG002|Baseline|Metformin + Topiramate|"Metformin~Topiramate"
11059261|NCT01351753|BG003|Baseline|Topiramate|Topiramate only
11059262|NCT01351753|BG004|Baseline|Metformin + Topiramate + Orlistat|"Metformin~Orlistat~Topiramate"
11059263|NCT01351753|BG005|Baseline|Placebo|Placebo: Placebo pills and capsules for metformin, orlistat and topiramate
11059264|NCT01351753|BG006|Baseline|Total|Total of all reporting groups
11059265|NCT01351753|FG000|Participant Flow|Metformin|Metformin only
11059266|NCT01351753|FG001|Participant Flow|Metformin + Orlistat|"Metformin~Orlistat"
11059267|NCT01351753|FG002|Participant Flow|Metformin + Topiramate|"Metformin~Topiramate"
11059268|NCT01351753|FG003|Participant Flow|Topiramate|Topiramate only
11059269|NCT01351753|FG004|Participant Flow|Metformin + Topiramate + Orlistat|"Metformin~Orlistat~Topiramate"
11059270|NCT01351753|FG005|Participant Flow|Placebo|Placebo: Placebo pills and capsules for metformin, orlistat and topiramate
11059271|NCT01351753|OG000|Outcome|Metformin|Metformin
11059272|NCT01351753|OG001|Outcome|Metformin + Orlistat|"Metformin~Orlistat"
11059273|NCT01351753|OG002|Outcome|Metformin + Topiramate|"Metformin~Topiramate"
11059274|NCT01351753|OG003|Outcome|Topiramate|Topiramate
11059275|NCT01351753|OG004|Outcome|Metformin + Topiramate + Orlistat|"Metformin~Orlistat~Topiramate"
11059276|NCT01351753|OG005|Outcome|Placebo|Placebo: Placebo pills and capsules for metformin, orlistat and topiramate
11059277|NCT01351753|OG000|Outcome|Metformin|Metformin only
11059278|NCT01351753|OG003|Outcome|Topiramate|Topiramate only
11059279|NCT01351753|EG000|Reported Event|Metformin|Metformin only
11059280|NCT01351753|EG001|Reported Event|Metformin + Orlistat|"Metformin~Orlistat"
11059281|NCT01351753|EG002|Reported Event|Metformin + Topiramate|"Metformin~Topiramate"
11059282|NCT01351753|EG003|Reported Event|Topiramate|Topiramate only
11059283|NCT01351753|EG004|Reported Event|Metformin + Topiramate + Orlistat|"Metformin~Orlistat~Topiramate"
11059284|NCT01351753|EG005|Reported Event|Placebo|Placebo: Placebo pills and capsules for metformin, orlistat and topiramate
11059285|NCT01351805|BG000|Baseline|ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids|ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
11059286|NCT01351805|BG001|Baseline|ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids|ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
11059287|NCT01351805|BG002|Baseline|PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids|PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
11059288|NCT01351805|BG003|Baseline|PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids|PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
11059289|NCT01351805|BG004|Baseline|Total|Total of all reporting groups
11059290|NCT01351805|FG000|Participant Flow|ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids|ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
11059291|NCT01351805|FG001|Participant Flow|ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids|ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
11059292|NCT01351805|FG002|Participant Flow|PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids|PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
11059293|NCT01351805|FG003|Participant Flow|PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids|PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
11059294|NCT01351805|OG000|Outcome|Active Vitamin D|Vitamin D3, one 2000 IU capsule/day
11059295|NCT01351805|OG001|Outcome|Placebo Vitamin D|Vitamin D placebo, one capsule/day
11059296|NCT01351805|OG002|Outcome|Active n-3 FA|Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
11059297|NCT01351805|OG003|Outcome|Placebo n-3 FA|Omega-3 fatty acids placebo, one capsule/day
11059298|NCT01351805|OG000|Outcome|Active n-3 FA|Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA) + Vitamin D3, one 2000 IU capsule/day or Vitamin D placebo, one capsule/day
11059299|NCT01351805|OG001|Outcome|Placebo n-3 FA|Omega-3 fatty acids placebo, one capsule/day + Vitamin D3, one 2000 IU capsule/day or Vitamin D placebo, one capsule/day
11059300|NCT01351805|OG000|Outcome|Active Vitamin D|Vitamin D3, one 2000 IU capsule/day + Omega 3 Omacor fatty acid, 1-g capsule/day or Omega-3 fatty acid placebo
11059301|NCT01351805|OG001|Outcome|Placebo Vitamin D|Placebo vitamin D3, one 2000 IU capsule/day + Omega 3 Omacor fatty acid, 1-g capsule/day or Omega-3 fatty acid placebo
11059302|NCT01351805|EG000|Reported Event|Active Vitamin D|Vitamin D3, one 2000 IU capsule/day
11059303|NCT01351805|EG001|Reported Event|Placebo Vitamin D|Vitamin D placebo, one capsule/day
11059304|NCT01351805|EG002|Reported Event|Active Omega-3 Fatty Acids|Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
11059305|NCT01351805|EG003|Reported Event|Omega-3 Fatty Acids Placebo|Omega-3 fatty acids placebo, one capsule/day
11059306|NCT01352117|BG000|Baseline|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
11059307|NCT01352117|BG001|Baseline|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
11059308|NCT01352117|BG002|Baseline|Total|Total of all reporting groups
11059309|NCT01352117|FG000|Participant Flow|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
11059310|NCT01352117|FG001|Participant Flow|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
11059311|NCT01352117|OG000|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
11059312|NCT01352117|OG001|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
11059313|NCT01352117|OG000|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
11059314|NCT01352117|OG000|Outcome|Arm A: ART With Delayed ET (Step 2)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis is limited to Arm A participants who entered Step 2 to initiate delayed ET.
11059315|NCT01352117|OG000|Outcome|Arm A: ART With Delayed ET Period (Step 2)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis was limited to the ART with delayed ET period (Step 2).
11059316|NCT01352117|EG000|Reported Event|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
11059317|NCT01352117|EG001|Reported Event|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
11059318|NCT01352182|BG000|Baseline|Pioglitazone Hydrochloride|Pioglitazone hydrochloride: Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.
11059319|NCT01352182|BG001|Baseline|Normal Standard Care|Routine normal standard care
11059320|NCT01352182|BG002|Baseline|Total|Total of all reporting groups
11059321|NCT01352182|FG000|Participant Flow|Pioglitazone Hydrochloride|Pioglitazone hydrochloride: Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.
11059322|NCT01352182|FG001|Participant Flow|Normal Standard Care|Received normal routine standard care
11059323|NCT01352182|OG000|Outcome|Pioglitazone Hydrochloride|Pioglitazone hydrochloride: Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.
11059324|NCT01352182|OG001|Outcome|Normal Standard Care|Routine normal standard care
11059325|NCT01352182|OG000|Outcome|Pioglitazone Hydrochloride by Mouth|Pioglitazone hydrochloride: Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days taken by mouth
11059326|NCT01352182|OG001|Outcome|Pioglitazone Hydrochloride by Nasogastric Tube|Pioglitazone hydrochloride: Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days taken by nasogastric tube
11059327|NCT01352182|EG000|Reported Event|Pioglitazone Hydrochloride|Pioglitazone hydrochloride: Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.
11059328|NCT01352182|EG001|Reported Event|Normal Standard Care|Routine normal standard care
11059329|NCT01352221|BG000|Baseline|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11059330|NCT01352221|BG001|Baseline|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11059331|NCT01352221|BG002|Baseline|Total|Total of all reporting groups
11059332|NCT01352221|FG000|Participant Flow|ST10|30mg ST10 capsules BD - double-blind phase
11059333|NCT01352221|FG001|Participant Flow|Placebo|Matching placebo for ST10 capsules - double-blind phase
11059334|NCT01352221|FG002|Participant Flow|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
11059335|NCT01352221|FG003|Participant Flow|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
11059336|NCT01352221|OG000|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11341976|NCT03694548|BG000|Baseline|Part A & B Adolescent Patients With SCD and Chronic Pain|"Part A: Adolescent patients with sickle cell disease (SCD) and chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.~Part B: Part A adolescent patients with SCD then had the opportunity to enroll in Part B yoga program."
11059337|NCT01352221|OG001|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11059338|NCT01352221|OG000|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase.
11059339|NCT01352221|OG001|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase.
11059340|NCT01352221|OG000|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
11059341|NCT01352221|OG001|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
11059342|NCT01352221|EG000|Reported Event|ST10 - Safety Set, Double-blind Phase|Adverse events reported in the double-blind phase active treatment arm with ST10 (Ferric Maltol). ST10 30 mg capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
11059343|NCT01352221|EG001|Reported Event|Placebo - Safety Set, Double-blind Phase|Adverse events reported in the double-blind phase placebo treatment arm. Matching placebo capsules for ST10 taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase
11059344|NCT01352221|EG002|Reported Event|ST10 Continuation - Safety Set, Open-label Phase|Adverse events reported in the open-label extension phase for continuation of active treatment with ST10 (Ferric Maltol) from the double-blind phase active treatment arm
11059345|NCT01352221|EG003|Reported Event|Placebo Switch to ST10 Treatment-Safety Set, Open-label Phase|Adverse events reported in the open-label extension phase from those subjects continuing treatment from the double-blind placebo arm; subjects commenced ST10 open-label treatment after completion of the double-blind phase at the Week 12 visit.
11059346|NCT01352286|BG000|Baseline|NYESO-1ᶜ²⁵⁹T Cells|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
11059347|NCT01352286|FG000|Participant Flow|NYESO-1ᶜ²⁵⁹T Cells Administered Intravenously|Participants who received lentivirus-mediated genetically engineered NYESO-1ᶜ²⁵⁹T following autologous stem cell transplantation (ASCT)
11059348|NCT01352286|OG000|Outcome|NYESO-1ᶜ²⁵⁹T Cells|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
11059349|NCT01352286|OG000|Outcome|NYESO-1ᶜ²⁵⁹T Cells|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with data at pre-and post-infusion time points
11059350|NCT01352286|EG000|Reported Event|NYESO-1ᶜ²⁵⁹T Cells|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
11059351|NCT01352442|BG000|Baseline|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
11059352|NCT01352442|FG000|Participant Flow|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
11059353|NCT01352442|OG000|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
11059354|NCT01352442|EG000|Reported Event|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
11059355|NCT01352468|BG000|Baseline|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
11059356|NCT01352468|BG001|Baseline|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
11059357|NCT01352468|BG002|Baseline|Total|Total of all reporting groups
11059358|NCT01352468|FG000|Participant Flow|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
11059359|NCT01352468|FG001|Participant Flow|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
11059360|NCT01352468|OG000|Outcome|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
11059361|NCT01352468|OG001|Outcome|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
11059362|NCT01352468|EG000|Reported Event|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
11059363|NCT01352468|EG001|Reported Event|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
11059364|NCT01352507|BG000|Baseline|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
11059365|NCT01352507|BG001|Baseline|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
11059366|NCT01352507|BG002|Baseline|Total|Total of all reporting groups
11059367|NCT01352507|FG000|Participant Flow|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
11059368|NCT01352507|FG001|Participant Flow|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
11059369|NCT01352507|OG000|Outcome|All Randomized Participants|Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
11059370|NCT01352507|OG000|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
11059371|NCT01352507|OG001|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
11059372|NCT01352507|OG000|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
11059373|NCT01352507|OG001|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
11059374|NCT01352507|OG000|Outcome|Tadalafil|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
11059375|NCT01352507|EG000|Reported Event|Tadalafil (Treatment Periods)|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
11059376|NCT01352507|EG001|Reported Event|Sildenafil (Treatment Periods)|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
11059377|NCT01352507|EG002|Reported Event|Tadalafil (Extension Phase)|Participants who preferred tadalafil over sildenafil received 20 mg tadalafil taken orally, as needed, for an additional 8 weeks.
11059378|NCT01352507|EG003|Reported Event|Sildenafil (Extension Phase)|Participants who preferred sildenafil over tadalafil received 100 mg sildenafil taken orally, as needed, for an additional 8 weeks.
11059379|NCT01352546|BG000|Baseline|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.~BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
11059380|NCT01352546|FG000|Participant Flow|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.~BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
11059381|NCT01352546|OG000|Outcome|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.~BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
11059382|NCT01352546|EG000|Reported Event|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.~BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
11059383|NCT01352585|BG000|Baseline|JAK2 Positive Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
11059384|NCT01352585|BG001|Baseline|JAK2 Negative Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
11059385|NCT01352585|BG002|Baseline|Total|Total of all reporting groups
11059386|NCT01352585|FG000|Participant Flow|JAK2 Positive Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
11059387|NCT01352585|FG001|Participant Flow|JAK2 Negative Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
11059388|NCT01352585|OG000|Outcome|JAK2 Positive Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
11059389|NCT01352585|OG001|Outcome|JAK2 Negative Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
11059390|NCT01352585|OG001|Outcome|JAK2 Negative Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician.
11059391|NCT01352585|EG000|Reported Event|JAK2 Positive Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
11059392|NCT01352585|EG001|Reported Event|JAK2 Negative Participants|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
11059393|NCT01352598|BG000|Baseline|Stereotactic Body Radiotherapy|"Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.~stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions.~For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions."
11059394|NCT01352598|FG000|Participant Flow|Stereotactic Body Radiotherapy|"Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.~stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions.~For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions."
11059395|NCT01352598|OG000|Outcome|Stereotactic Body Radiotherapy|"Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.~stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions.~For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions."
11059396|NCT01352598|EG000|Reported Event|Stereotactic Body Radiotherapy|"Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.~stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions.~For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions."
11059397|NCT01352637|BG000|Baseline|Virtual Reality Exposure (VRE)+Drug: DCycloserine (DCS)|Virtual Reality Exposure (VRE): PTSD treatment + D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
11059398|NCT01352637|BG001|Baseline|Prolonged Imaginal Exposure (PE)+Drug: DCycloserine (DCS)|Prolonged Imaginal Exposure (PE): PTSD treatment + D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
11059399|NCT01352637|BG002|Baseline|Virtual Reality Exposure (VRE)+Drug: Placebo|Virtual Reality Exposure (VRE): PTSD treatment + Placebo (sugar pill) (taken once a week on the day of the therapy session)
11059400|NCT01352637|BG003|Baseline|Prolonged Imaginal Exposure (PE)+Drug: Placebo|Prolonged Imaginal Exposure (PE): PTSD treatment + Placebo (sugar pill) (taken once a week on the day of the therapy session)
11059401|NCT01352637|BG004|Baseline|Total|Total of all reporting groups
11059402|NCT01352637|FG000|Participant Flow|Virtual Reality Exposure (VRE)|Virtual Reality Exposure (VRE): PTSD treatment
11059403|NCT01352637|FG001|Participant Flow|Prolonged Imaginal Exposure (PE)|"Drug: Placebo (sugar pill) + Virtual Reality Exposure (VR) PTSD treatment~Prolonged Imaginal Exposure (PE): PTSD treatment"
11059404|NCT01352637|FG002|Participant Flow|Drug: D-Cycloserine (DCS)|D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
11059405|NCT01352637|FG003|Participant Flow|Drug: Placebo|Drug: Placebo (sugar pill) (taken once a week on the day of the therapy session)
11059406|NCT01352637|OG000|Outcome|Virtual Reality Exposure (VRE)|Virtual Reality Exposure (VRE): PTSD treatment
11059407|NCT01352637|OG001|Outcome|Prolonged Imaginal Exposure (PE)|Prolonged Imaginal Exposure (PE): PTSD treatment
11059408|NCT01352637|OG002|Outcome|Drug: D-Cycloserine (DCS)|D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
11059409|NCT01352637|OG003|Outcome|Drug: Placebo|Drug: Placebo (sugar pill) (taken once a week on the day of the therapy session)
11059410|NCT01352637|EG000|Reported Event|Virtual Reality Exposure (VRE)|Virtual Reality Exposure (VRE): PTSD treatment
11059411|NCT01352637|EG001|Reported Event|Prolonged Imaginal Exposure (PE)|Prolonged Imaginal Exposure (PE): PTSD treatment
11059412|NCT01352637|EG002|Reported Event|Drug: D-Cycloserine (DCS)|D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
11059413|NCT01352637|EG003|Reported Event|Drug: Placebo|Drug: Placebo (sugar pill) (taken once a week on the day of the therapy session)
11059414|NCT01352715|BG000|Baseline|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
11059415|NCT01352715|BG001|Baseline|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
11059416|NCT01352715|BG002|Baseline|Total|Total of all reporting groups
11059417|NCT01352715|FG000|Participant Flow|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
11059418|NCT01352715|FG001|Participant Flow|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
11059419|NCT01352715|OG000|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
11059420|NCT01352715|OG001|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
11059421|NCT01352715|EG000|Reported Event|LPV/r + RAL|Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily.
11059422|NCT01352715|EG001|Reported Event|LPV/r + NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily."
11059423|NCT01352741|BG000|Baseline|All Trial Participants|All participants that received at least one dose of tapentadol prolonged release at baseline, in the open-label titration period.
11059424|NCT01352741|FG000|Participant Flow|Tapentadol Prolonged Release|All participants entered the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion. Participants that did not qualify for entry into the Comparative Period were able to enter the open-label Continuation Period. During the double-blind comparator phase the dose was increased to 200 mg twice daily and after a week to 250 mg twice daily. Participants that dropped out due to tolerability issues during the comparative period were able to enter the open-label pick-up arm.
11059425|NCT01352741|FG001|Participant Flow|Tapentadol Prolonged Release and Pregabalin|At the end of the Open-label Tapentadol Titration Period participants that qualified were randomized to either tapentadol or tapentadol and pregabalin treatment. In this double-blind period participants started on Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
11059426|NCT01352741|OG000|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
11059427|NCT01352741|OG001|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
11059428|NCT01352741|OG000|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
11059429|NCT01352741|OG000|Outcome|Tapentadol Prolonged Release|Participants that did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day, if they had reached a satisfactory level of pain relief.
11059430|NCT01352741|OG000|Outcome|Tapentadol Prolonged Release After Tapentadol|Participants that drop-out of the double-blind tapentadol prolonged release treatment in the Comparative Period, due to tolerability issues, continued on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day in this Open-Label Pick-up arm.
11059431|NCT01352741|OG001|Outcome|Tapentadol Prolonged Release After Tapentadol and Pregabalin|Participants that dropped-out of the Tapentadol Prolonged Release and Pregabalin in the double-blind Comparative Period continued with Tapentadol Prolonged Release at either 300 or 400 mg per day in this Open-Label Pick-up arm.
11059432|NCT01352741|OG000|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration
11059433|NCT01352741|OG000|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
11059434|NCT01352741|OG001|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
11059435|NCT01352741|OG002|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
11059436|NCT01352741|OG000|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period.
11059437|NCT01352741|OG000|Outcome|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
11059438|NCT01352741|OG001|Outcome|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
11059439|NCT01352741|EG000|Reported Event|Open-Label Tapentadol Titration Period|"During the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion.~Titration dose steps on a weekly basis:~First 50 mg administered twice daily, then 100 mg administered twice daily and then 150 mg administered twice daily.~The titration period could be shortened to 10 days, with a participant at a predefined dose level for at least 3 days.~The dose of 300 mg Tapentadol per day was maintained until the Randomization Visit."
11059440|NCT01352741|EG001|Reported Event|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
11059441|NCT01352741|EG002|Reported Event|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
11059442|NCT01352741|EG003|Reported Event|Open-Label Tapentadol Pick-Up Arm|Participants that drop-out of the Comparative Period, due to tolerability issues, were permitted to continue on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day.
11059443|NCT01352741|EG004|Reported Event|Open-Label Tapentadol Continuation Period|Participants who did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day if they had reached a satisfactory level of pain relief.
11059444|NCT01352793|BG000|Baseline|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
11059445|NCT01352793|BG001|Baseline|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
11059446|NCT01352793|BG002|Baseline|Total|Total of all reporting groups
11059447|NCT01352793|FG000|Participant Flow|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
11059448|NCT01352793|FG001|Participant Flow|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
11059449|NCT01352793|OG000|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
11059450|NCT01352793|OG001|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
11059451|NCT01352793|EG000|Reported Event|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
11059452|NCT01352793|EG001|Reported Event|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
11059453|NCT01352845|BG000|Baseline|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
11059454|NCT01352845|BG001|Baseline|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
11059455|NCT01352845|BG002|Baseline|Total|Total of all reporting groups
11059456|NCT01352845|FG000|Participant Flow|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
11059457|NCT01352845|FG001|Participant Flow|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
11059458|NCT01352845|OG000|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
11059459|NCT01352845|OG001|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
11059460|NCT01352845|EG000|Reported Event|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
11059461|NCT01352845|EG001|Reported Event|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
11059462|NCT01353079|BG000|Baseline|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
11059463|NCT01353079|BG001|Baseline|Glycero-COCAs|Placebo: Glycero-COCAS sublingual
11059464|NCT01353079|BG002|Baseline|Total|Total of all reporting groups
11059465|NCT01353079|FG000|Participant Flow|Short Ragweed Pollen Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
11059466|NCT01353079|FG001|Participant Flow|Glycero-COCAs|Placebo-Glycero-COCAs sublingual
11059467|NCT01353079|OG000|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
11059468|NCT01353079|OG001|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
11059469|NCT01353079|OG000|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
11059470|NCT01353079|OG000|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
11059471|NCT01353079|EG000|Reported Event|Ragweed Allergenic Extract|"allergy immunotherapy: Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.~placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual"
11059472|NCT01353079|EG001|Reported Event|Glycero-Cocas|placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
11059473|NCT01353144|BG000|Baseline|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
11059474|NCT01353144|BG001|Baseline|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
11059475|NCT01353144|BG002|Baseline|Total|Total of all reporting groups
11059476|NCT01353144|FG000|Participant Flow|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
11059477|NCT01353144|FG001|Participant Flow|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
11059478|NCT01353144|OG000|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
11059479|NCT01353144|OG001|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
11059480|NCT01353144|OG000|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
11059481|NCT01353144|OG001|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
11059482|NCT01353144|EG000|Reported Event|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
11059483|NCT01353144|EG001|Reported Event|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
11059484|NCT01353196|BG000|Baseline|Stenosis|carotid stenosis
11059485|NCT01353196|BG001|Baseline|no Stenosis|no carotid artery stenosis
11059486|NCT01353196|BG002|Baseline|Total|Total of all reporting groups
11059487|NCT01353196|FG000|Participant Flow|Stenosis|participants with carotid stenosis
11059488|NCT01353196|FG001|Participant Flow|no Stenosis|participants with no carotid artery stenosis
11059489|NCT01353196|OG000|Outcome|Stenosis|carotid stenosis
11059490|NCT01353196|OG001|Outcome|no Stenosis|no carotid artery stenosis
11059491|NCT01353196|EG000|Reported Event|Stenosis|carotid stenosis
11059492|NCT01353196|EG001|Reported Event|no Stenosis|no carotid artery stenosis
11059493|NCT01353222|BG000|Baseline|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
11059494|NCT01353222|BG001|Baseline|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
11059495|NCT01353222|BG002|Baseline|Total|Total of all reporting groups
11059496|NCT01353222|FG000|Participant Flow|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
11059497|NCT01353222|FG001|Participant Flow|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
11066833|NCT01393990|OG015|Outcome|Part C: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
11059498|NCT01353222|OG000|Outcome|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
11059499|NCT01353222|OG001|Outcome|Standard of Care|"Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.~Standard of Care: Standard of care"
11059500|NCT01353222|EG000|Reported Event|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
11059501|NCT01353222|EG001|Reported Event|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
11059502|NCT01353274|BG000|Baseline|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
11059503|NCT01353274|FG000|Participant Flow|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
11059504|NCT01353274|OG000|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
11059505|NCT01353274|EG000|Reported Event|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
11059506|NCT01353495|BG000|Baseline|Standard Wound Care|"Standard Wound care (gels, foams, dressings.)~Wound Debridement : Wounds debrided in both arms of study"
11059507|NCT01353495|BG001|Baseline|Treatment With Study Device|"Treatment with Biotape Acelular Dermis Graft~APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.~Wound Debridement : Wounds debrided in both arms of study"
11059508|NCT01353495|BG002|Baseline|Total|Total of all reporting groups
11059509|NCT01353495|FG000|Participant Flow|Standard Wound Care|"Standard Wound care (gels, foams, dressings.)~Wound Debridement : Wounds debrided in both arms of study"
11059510|NCT01353495|FG001|Participant Flow|Treatment With Study Device|"Treatment with Biotape Acelular Dermis Graft~APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.~Wound Debridement : Wounds debrided in both arms of study"
11059511|NCT01353495|OG000|Outcome|Treatment With Study Device|"Treatment with Biotape Acelular Dermis Graft~APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.~Wound Debridement : Wounds debrided in both arms of study"
11059512|NCT01353495|OG001|Outcome|Standard Wound Care|"Standard Wound care (gels, foams, dressings.)~Wound Debridement : Wounds debrided in both arms of study"
11059513|NCT01353495|EG000|Reported Event|Standard Wound Care|"Standard Wound care (gels, foams, dressings.)~Wound Debridement : Wounds debrided in both arms of study"
11059514|NCT01353495|EG001|Reported Event|Treatment With Study Device|"Treatment with Biotape Acelular Dermis Graft~APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.~Wound Debridement : Wounds debrided in both arms of study"
11059515|NCT01353508|BG000|Baseline|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
11059516|NCT01353508|BG001|Baseline|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
11059517|NCT01353508|BG002|Baseline|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
11059518|NCT01353508|BG003|Baseline|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
11059519|NCT01353508|BG004|Baseline|Total|Total of all reporting groups
11341977|NCT03694548|BG001|Baseline|Parents of Patients in Part A (Group 2)|Parents of patients in Part A completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.
11059520|NCT01353508|FG000|Participant Flow|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
11059521|NCT01353508|FG001|Participant Flow|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
11059522|NCT01353508|FG002|Participant Flow|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
11059523|NCT01353508|FG003|Participant Flow|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
11059524|NCT01353508|OG000|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
11059525|NCT01353508|OG001|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
11059526|NCT01353508|OG002|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
11059527|NCT01353508|OG003|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
11059528|NCT01353508|EG000|Reported Event|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
11059529|NCT01353508|EG001|Reported Event|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
11059530|NCT01353508|EG002|Reported Event|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
11059531|NCT01353508|EG003|Reported Event|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
11059532|NCT01353586|BG000|Baseline|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
11059533|NCT01353586|BG001|Baseline|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
11059534|NCT01353586|BG002|Baseline|Total|Total of all reporting groups
11059535|NCT01353586|FG000|Participant Flow|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
11059536|NCT01353586|FG001|Participant Flow|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
11059537|NCT01353586|OG000|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
11059538|NCT01353586|OG000|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
11059539|NCT01353586|OG000|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
11059540|NCT01353586|OG001|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
11059541|NCT01353586|OG001|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are related for transparency; but cannot be compared statistically against the data from the Main Study group."
11059542|NCT01353586|EG000|Reported Event|nMARQ™ System (Main Study)|nMARQ™ is the Biosense Webster Pulmonary Vein Isolation System consists of Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator. This system is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously for treating paroxysmal atrial fibrillation (PAF).
11059543|NCT01353586|EG001|Reported Event|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
11059544|NCT01353664|BG000|Baseline|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
11059545|NCT01353664|FG000|Participant Flow|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
11059546|NCT01353664|OG000|Outcome|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
11059547|NCT01353664|EG000|Reported Event|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
11059548|NCT01353703|BG000|Baseline|Infanrix Hexa 6-10-14 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
11059549|NCT01353703|BG001|Baseline|Infanrix Hexa 2-4-6 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
11059550|NCT01353703|BG002|Baseline|Total|Total of all reporting groups
11059551|NCT01353703|FG000|Participant Flow|Infanrix Hexa 6-10-14 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
11059552|NCT01353703|FG001|Participant Flow|Infanrix Hexa 2-4-6 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
11059553|NCT01353703|OG000|Outcome|Infanrix Hexa 6-10-14 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
11059554|NCT01353703|OG001|Outcome|Infanrix Hexa 2-4-6 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
11059555|NCT01353703|OG000|Outcome|Infanrix Hexa 6-10-14 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
11059556|NCT01353703|OG001|Outcome|Infanrix Hexa 2-4-6 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
11059557|NCT01353703|EG000|Reported Event|Infanrix Hexa 6-10-14 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
11059558|NCT01353703|EG001|Reported Event|Infanrix Hexa 2-4-6 Group|Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
11059559|NCT01353859|BG000|Baseline|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
11059560|NCT01353859|FG000|Participant Flow|Tocilizumab + Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (minimum dose 480 mg, maximum dose 800 mg), intravenously (IV), once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
11059561|NCT01353859|OG000|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
11059562|NCT01353859|EG000|Reported Event|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
11059563|NCT01353898|BG000|Baseline|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059564|NCT01353898|BG001|Baseline|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059565|NCT01353898|BG002|Baseline|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059566|NCT01353898|BG003|Baseline|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
11059567|NCT01353898|BG004|Baseline|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
11059568|NCT01353898|BG005|Baseline|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
11059569|NCT01353898|BG006|Baseline|Total|Total of all reporting groups
11059570|NCT01353898|FG000|Participant Flow|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059571|NCT01353898|FG001|Participant Flow|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059572|NCT01353898|FG002|Participant Flow|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
10887125|NCT00498927|BG000|Baseline|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
11059573|NCT01353898|FG003|Participant Flow|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
11059574|NCT01353898|FG004|Participant Flow|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
11059575|NCT01353898|FG005|Participant Flow|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
11059576|NCT01353898|OG000|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059577|NCT01353898|OG001|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059578|NCT01353898|OG002|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059579|NCT01353898|OG003|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
11059580|NCT01353898|OG004|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
11059581|NCT01353898|OG005|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
11059582|NCT01353898|EG000|Reported Event|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11341978|NCT03694548|BG002|Baseline|Total|Total of all reporting groups
10887126|NCT00498927|FG000|Participant Flow|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
10887127|NCT00498927|OG000|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
11059583|NCT01353898|EG001|Reported Event|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059584|NCT01353898|EG002|Reported Event|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
11059585|NCT01353898|EG003|Reported Event|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
11059586|NCT01353898|EG004|Reported Event|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
11059587|NCT01353898|EG005|Reported Event|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
11059588|NCT01353911|BG000|Baseline|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059589|NCT01353911|BG001|Baseline|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059590|NCT01353911|BG002|Baseline|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059591|NCT01353911|BG003|Baseline|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059592|NCT01353911|BG004|Baseline|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059593|NCT01353911|BG005|Baseline|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059594|NCT01353911|BG006|Baseline|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059595|NCT01353911|BG007|Baseline|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
11059596|NCT01353911|BG008|Baseline|Total|Total of all reporting groups
11059597|NCT01353911|FG000|Participant Flow|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059598|NCT01353911|FG001|Participant Flow|Grazoprevir 100 mg|TN non-cirrhotic (NC) participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059599|NCT01353911|FG002|Participant Flow|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059600|NCT01353911|FG003|Participant Flow|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059601|NCT01353911|FG004|Participant Flow|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059602|NCT01353911|FG005|Participant Flow|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059603|NCT01353911|FG006|Participant Flow|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059604|NCT01353911|FG007|Participant Flow|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
11059605|NCT01353911|OG000|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059606|NCT01353911|OG001|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059607|NCT01353911|OG002|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059608|NCT01353911|OG003|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059609|NCT01353911|OG004|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11066834|NCT01393990|OG016|Outcome|Part D: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11059610|NCT01353911|OG005|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059611|NCT01353911|OG006|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059612|NCT01353911|OG007|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
11059613|NCT01353911|EG000|Reported Event|Cirr: OL Grazoprevir 100 mg|TN cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059614|NCT01353911|EG001|Reported Event|Non-cirr: Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059615|NCT01353911|EG002|Reported Event|Non-cirr: Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059616|NCT01353911|EG003|Reported Event|Non-cirr: Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059617|NCT01353911|EG004|Reported Event|Non-cirr: Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059618|NCT01353911|EG005|Reported Event|Non-cirr: Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059619|NCT01353911|EG006|Reported Event|Non-cirr: Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
11059620|NCT01353911|EG007|Reported Event|Non-cirr: Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
11059621|NCT01353963|BG000|Baseline|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
11059622|NCT01353963|FG000|Participant Flow|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
11059623|NCT01353963|OG000|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
11059624|NCT01353963|EG000|Reported Event|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
11059625|NCT01353976|BG000|Baseline|Econazole Nitrate Foam 1%|Study medication
11059626|NCT01353976|BG001|Baseline|Vehicle Foam|Placebo medication
11059627|NCT01353976|BG002|Baseline|Total|Total of all reporting groups
11059628|NCT01353976|FG000|Participant Flow|Econazole Nitrate Foam 1%|Study medication
11059629|NCT01353976|FG001|Participant Flow|Vehicle Foam|Placebo medication
11059630|NCT01353976|OG000|Outcome|Econazole Nitrate Foam 1%|Study medication
11059631|NCT01353976|OG001|Outcome|Vehicle Foam|Placebo medication
11059632|NCT01353976|EG000|Reported Event|Econazole Nitrate Foam 1%|Study medication
11059633|NCT01353976|EG001|Reported Event|Vehicle Foam|Placebo medication
11059634|NCT01354015|BG000|Baseline|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
11059635|NCT01354015|BG001|Baseline|Usual Care|Usual Care
11059636|NCT01354015|BG002|Baseline|Total|Total of all reporting groups
11059637|NCT01354015|FG000|Participant Flow|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
11059638|NCT01354015|FG001|Participant Flow|Usual Care|Usual Care
11059639|NCT01354015|OG000|Outcome|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
11059640|NCT01354015|OG001|Outcome|Usual Care|Usual Care
11059641|NCT01354015|EG000|Reported Event|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
11059642|NCT01354015|EG001|Reported Event|Usual Care|Usual Care
11059643|NCT01354028|BG000|Baseline|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
11059644|NCT01354028|FG000|Participant Flow|Massage Therapy First Day, no Massage Therapy Second Day|"Day one of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.~Day two of study: No massage therapy. Actigraph in place to measure sleep for 3 hours"
11059645|NCT01354028|FG001|Participant Flow|No Massage Therapy First Day, Massage Therapy Second Day|"Day one of study: No massage therapy. Actigraph in place to measure sleep for 3 hours.~Day two of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours."
11059646|NCT01354028|OG000|Outcome|Sleep Efficiency With Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
11059647|NCT01354028|OG001|Outcome|Sleep Efficiency With no Massage Therapy|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
11059648|NCT01354028|OG000|Outcome|Oxygen Saturation During Massage|Oxygen saturation during massage therapy
11059649|NCT01354028|OG001|Outcome|Oxygen Saturation Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
11059650|NCT01354028|OG000|Outcome|Heart Rate During Massage|Heart rate during massage therapy
11059651|NCT01354028|OG001|Outcome|Heart Rate Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
11059652|NCT01354028|OG000|Outcome|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
11059653|NCT01354028|OG001|Outcome|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
11059654|NCT01354028|EG000|Reported Event|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
11059655|NCT01354028|EG001|Reported Event|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
11059656|NCT01354106|BG000|Baseline|Infant|Investigational adhesive tape control paper tape
11059657|NCT01354106|FG000|Participant Flow|Adhesive Medical Tape|"Each study participant received both treatment arms: 3M Kind Removal Silicone Tape (1 x 1.5 sample, applied one time, worn 24 hours) and 3M Micropore Silicone Tape (1 x 1.5 sample, applied one ime, worn 24 hours)."
11059658|NCT01354106|OG000|Outcome|3M Kind Removal Silicone Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
11059659|NCT01354106|OG001|Outcome|3M Micropore Medical Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
11059660|NCT01354106|EG000|Reported Event|Investigational Adhesive Tape|
11059661|NCT01354106|EG001|Reported Event|Control Paper Tape|
11059662|NCT01354132|BG000|Baseline|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059663|NCT01354132|BG001|Baseline|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059664|NCT01354132|BG002|Baseline|Total|Total of all reporting groups
11059665|NCT01354132|FG000|Participant Flow|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059666|NCT01354132|FG001|Participant Flow|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059667|NCT01354132|OG000|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059668|NCT01354132|OG001|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059669|NCT01354132|OG000|Outcome|N-acetyl-cysteine|n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
11059670|NCT01354132|OG000|Outcome|Placebo Group|"Placebo comparison group for study matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059671|NCT01354132|OG000|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
11059672|NCT01354132|EG000|Reported Event|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059673|NCT01354132|EG001|Reported Event|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
11059674|NCT01354145|BG000|Baseline|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
11059675|NCT01354145|BG001|Baseline|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
11059676|NCT01354145|BG002|Baseline|Total|Total of all reporting groups
11059677|NCT01354145|FG000|Participant Flow|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
11059678|NCT01354145|FG001|Participant Flow|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
11059679|NCT01354145|OG000|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
11059680|NCT01354145|OG001|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
11059681|NCT01354145|EG000|Reported Event|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
11059682|NCT01354145|EG001|Reported Event|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
11059683|NCT01354197|BG000|Baseline|Survive at Day 28|The patients who survived at 28 days after surgical ICU admission.
11059684|NCT01354197|BG001|Baseline|Non-survive at Day 28|The patients who non-survived at 28 days after surgical ICU admission.
11059685|NCT01354197|BG002|Baseline|Total|Total of all reporting groups
11059686|NCT01354197|FG000|Participant Flow|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
11059687|NCT01354197|OG000|Outcome|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
11059688|NCT01354197|EG000|Reported Event|Survive at Day 28|Number of participants who survive at day 28
11059689|NCT01354197|EG001|Reported Event|Non-survive at Day 28|Number of participants who Did Not survive at day 28
11059690|NCT01354223|BG000|Baseline|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
11059691|NCT01354223|BG001|Baseline|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
11059692|NCT01354223|BG002|Baseline|Total|Total of all reporting groups
11059693|NCT01354223|FG000|Participant Flow|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
11059694|NCT01354223|FG001|Participant Flow|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
11059695|NCT01354223|OG000|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
11059696|NCT01354223|OG001|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
11059697|NCT01354223|EG000|Reported Event|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
11059698|NCT01354223|EG001|Reported Event|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
11059699|NCT01354314|BG000|Baseline|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
11059700|NCT01354314|BG001|Baseline|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
11059701|NCT01354314|BG002|Baseline|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
11059702|NCT01354314|BG003|Baseline|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
11059703|NCT01354314|BG004|Baseline|Total|Total of all reporting groups
11059704|NCT01354314|FG000|Participant Flow|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
11059705|NCT01354314|FG001|Participant Flow|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
11059706|NCT01354314|FG002|Participant Flow|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
11059707|NCT01354314|FG003|Participant Flow|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
11059708|NCT01354314|OG000|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
11059709|NCT01354314|OG001|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
11059710|NCT01354314|OG002|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
11059711|NCT01354314|OG003|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
11059712|NCT01354314|OG001|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
11059713|NCT01354314|OG002|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
11059714|NCT01354314|EG000|Reported Event|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
11059715|NCT01354314|EG001|Reported Event|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
11059716|NCT01354314|EG002|Reported Event|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
11059717|NCT01354314|EG003|Reported Event|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
11059718|NCT01354353|BG000|Baseline|Aripiprazole|Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).
11059719|NCT01354353|BG001|Baseline|160 mg LY2140023|"160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.~(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)"
11059720|NCT01354353|BG002|Baseline|240 mg LY2140023|240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059721|NCT01354353|BG003|Baseline|320 mg LY2140023|320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059722|NCT01354353|BG004|Baseline|400 mg LY2140023|400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059723|NCT01354353|BG005|Baseline|480 mg LY2140023|480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059724|NCT01354353|BG006|Baseline|Total|Total of all reporting groups
11059725|NCT01354353|FG000|Participant Flow|Aripiprazole|Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).
11059726|NCT01354353|FG001|Participant Flow|160 mg LY2140023|160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059727|NCT01354353|FG002|Participant Flow|240 mg LY2140023|240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059728|NCT01354353|FG003|Participant Flow|320 mg LY2140023|320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059729|NCT01354353|FG004|Participant Flow|400 mg LY2140023|400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059730|NCT01354353|FG005|Participant Flow|480 mg LY2140023|480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
10887128|NCT00498927|EG000|Reported Event|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
10887351|NCT00499915|OG001|Outcome|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
11059731|NCT01354353|OG000|Outcome|Aripiprazole|Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).
11059732|NCT01354353|OG001|Outcome|160 mg LY2140023|"160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.~(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)"
11059733|NCT01354353|OG002|Outcome|240 mg LY2140023|240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059734|NCT01354353|OG003|Outcome|320 mg LY2140023|320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059735|NCT01354353|OG004|Outcome|400 mg LY2140023|400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059736|NCT01354353|OG005|Outcome|480 mg LY2140023|480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059737|NCT01354353|OG000|Outcome|160 mg LY2140023|"160 milligrams (mg) LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.~Not included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16."
11059738|NCT01354353|OG001|Outcome|240 mg LY2140023|240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059739|NCT01354353|OG002|Outcome|320 mg LY2140023|320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059740|NCT01354353|OG003|Outcome|400 mg LY2140023|400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059741|NCT01354353|OG004|Outcome|480 mg LY2140023|480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059742|NCT01354353|OG000|Outcome|160 mg LY2140023|160 milligrams (mg) LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059743|NCT01354353|OG000|Outcome|160 mg LY2140023|"160 milligrams (mg) administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.~Not included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16."
11059744|NCT01354353|EG000|Reported Event|Aripiprazole|Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).
11059745|NCT01354353|EG001|Reported Event|160 mg LY2140023|"160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.~(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)"
11059746|NCT01354353|EG002|Reported Event|240 mg LY2140023|240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059747|NCT01354353|EG003|Reported Event|320 mg LY2140023|320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059748|NCT01354353|EG004|Reported Event|400 mg LY2140023|400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059749|NCT01354353|EG005|Reported Event|480 mg LY2140023|480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
11059750|NCT01354444|BG000|Baseline|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
11059751|NCT01354444|BG001|Baseline|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
11059752|NCT01354444|BG002|Baseline|Total|Total of all reporting groups
11059753|NCT01354444|FG000|Participant Flow|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
11059754|NCT01354444|FG001|Participant Flow|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
11059755|NCT01354444|OG000|Outcome|HVLT Score in Placebo Group|Descriptive statistics for immediate recall in the Hopkins Verbal Learning Test in the placebo group
11059756|NCT01354444|OG001|Outcome|HVLT Score in Treatment Group|Descriptive statistics for immediate recall in the Hopkins Verbal Learning Test in the treatment group
11059757|NCT01354444|OG000|Outcome|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
11059758|NCT01354444|OG001|Outcome|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
11059759|NCT01354444|EG000|Reported Event|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
11059760|NCT01354444|EG001|Reported Event|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
11059761|NCT01354496|BG000|Baseline|LY2409021 Cohort 1|"Participants randomized to 1 of 3 sequences and received a single but different intervention per period: Sequence 1 (reference capsules fasting, then test-medium tablet fasting, then test-medium tablet after high-fat meal), Sequence 2 (test-medium tablet fasting, then test-medium tablet after high-fat meal, then reference capsules fasting), or Sequence 3 (test-medium tablet after high-fat meal, then reference capsules fasting, then test-medium tablet fasting).~There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting [20-milligram (mg) LY2409021 dose, administered orally, once in fasted state], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal)."
11059762|NCT01354496|BG001|Baseline|LY2409021 Cohort 2|"Participants randomized to 1 of 3 sequences and received a single but different intervention per period: Sequence 4 (test-medium tablet fasting then, test-high tablet fasting, then test-low tablet fasting), Sequence 5 (test-high tablet fasting then, test-low tablet fasting, then test-medium tablet fasting), or Sequence 6 (test-low tablet fasting, then test-medium tablet fasting, then test-high tablet fasting).~There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state)."
11059763|NCT01354496|BG002|Baseline|Total|Total of all reporting groups
11059764|NCT01354496|FG000|Participant Flow|LY2409021 Cohort 1: Sequence 1|"Sequence 1: (Period 1:reference capsules fasting, then Period 2: test-medium tablet fasting, then Period 3: test-medium tablet after high-fat meal).~There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting [20-milligram (mg) LY2409021 dose, administered orally, once in fasted state], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal)."
11059765|NCT01354496|FG001|Participant Flow|LY2409021 Cohort 1: Sequence 2|"Sequence 2: (Period 1: test-medium tablet fasting, then Period 2: test-medium tablet after high-fat meal, then Period 3: reference capsules fasting).~There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting [20-milligram (mg) LY2409021 dose, administered orally, once in fasted state], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal)."
11059766|NCT01354496|FG002|Participant Flow|LY2409021 Cohort 1: Sequence 3|"Sequence 3: (Period 1:test-medium tablet after high-fat meal, then Period 2: reference capsules fasting, then Period 3: test-medium tablet fasting).~There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting [20-milligram (mg) LY2409021 dose, administered orally, once in fasted state], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal)."
11059767|NCT01354496|FG003|Participant Flow|LY2409021 Cohort 2: Sequence 4|Sequence 4: (Period 1: test-medium tablet fasting then, Period 2: test-high tablet fasting, then Period 3: test-low tablet fasting) There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
11059768|NCT01354496|FG004|Participant Flow|LY2409021 Cohort 2: Sequence 5|Sequence 5: (Period 1: test-high tablet fasting then, Period 2: test-low tablet fasting, then Period 3: test-medium tablet fasting) There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
11059769|NCT01354496|FG005|Participant Flow|LY2409021 Cohort 2: Sequence 6|"Sequence 6: (Period1: test-low tablet fasting, then Period 2: test-medium tablet fasting, then Period 3: test-high tablet fasting).~There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state)."
11059770|NCT01354496|OG000|Outcome|LY2409021 Cohort 1 (Test-Medium Tablet Fasted)|A single 20-milligram (mg) LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059771|NCT01354496|OG001|Outcome|LY2409021 Cohort 1 (Reference Capsules Fasted)|A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
11059772|NCT01354496|OG000|Outcome|LY2409021 Cohort 1 (Test-Medium Tablet Fasted)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059773|NCT01354496|OG000|Outcome|LY2409021 Cohort 1 (Test-Medium Tablet Fed)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once, immediately after a standardized high-fat meal, during Period 1, 2, or 3.
11059774|NCT01354496|OG001|Outcome|LY2409021 Cohort 1 (Test-Medium Tablet Fasted)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059775|NCT01354496|OG000|Outcome|LY2409021 Cohort 1 (Reference Capsules Fasted)|A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
11059776|NCT01354496|OG001|Outcome|LY2409021 Cohort 1 (Test-Medium Tablet Fed)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once, immediately after a standardized high-fat meal, during Period 1, 2, or 3.
11059777|NCT01354496|OG002|Outcome|LY2409021 Cohort 1 (Test-Medium Tablet Fasted)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059778|NCT01354496|OG003|Outcome|LY2409021 Cohort 2 (Test-Low Tablet Fasted)|A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059779|NCT01354496|OG004|Outcome|LY2409021 Cohort 2 (Test-Medium Tablet Fasted)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059780|NCT01354496|OG005|Outcome|LY2409021 Cohort 2 (Test-High Tablet Fasted)|A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059781|NCT01354496|OG000|Outcome|LY2409021 Cohort 2 (Test-Low Tablet Fasted)|A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059782|NCT01354496|OG001|Outcome|LY2409021 Cohort 2 (Test-High Tablet Fasted)|A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059783|NCT01354496|OG002|Outcome|LY2409021 Cohort 2 (Test-Medium Tablet Fasted)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059784|NCT01354496|EG000|Reported Event|LY2409021 Cohort 1 (Reference Capsules Fasted)|A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
11059785|NCT01354496|EG001|Reported Event|LY2409021 Cohort 1 (Test-Medium Tablet Fed)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once, immediately after a standardized high-fat meal, during Period 1, 2, or 3.
11059786|NCT01354496|EG002|Reported Event|LY2409021 Cohort 2 (Test-Low Tablet Fasted)|A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059787|NCT01354496|EG003|Reported Event|LY2409021 Cohorts 1 and 2 (Test-Medium Tablet Fasted)|A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059788|NCT01354496|EG004|Reported Event|LY2409021 Cohort 2 (Test-High Tablet Fasted)|A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
11059789|NCT01354652|BG000|Baseline|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059790|NCT01354652|BG001|Baseline|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059791|NCT01354652|BG002|Baseline|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
11059792|NCT01354652|BG003|Baseline|Total|Total of all reporting groups
11059793|NCT01354652|FG000|Participant Flow|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059794|NCT01354652|FG001|Participant Flow|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059795|NCT01354652|FG002|Participant Flow|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
11059796|NCT01354652|OG000|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059797|NCT01354652|OG001|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059798|NCT01354652|OG002|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
11059799|NCT01354652|OG001|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059800|NCT01354652|EG000|Reported Event|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059801|NCT01354652|EG001|Reported Event|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
11059802|NCT01354652|EG002|Reported Event|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
11059803|NCT01354691|BG000|Baseline|Ladostigil Hemitartrate|"Ladostigil capsules 80 mg~ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage."
11059804|NCT01354691|BG001|Baseline|Placebo|"Placebo capsules~ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage."
11059805|NCT01354691|BG002|Baseline|Total|Total of all reporting groups
11059806|NCT01354691|FG000|Participant Flow|Ladostigil Hemitartrate|"Ladostigil capsules 80 mg~ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage."
11059807|NCT01354691|FG001|Participant Flow|Placebo|"Placebo capsules~ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage."
11059808|NCT01354691|OG000|Outcome|Ladostigil Hemitartrate|"Ladostigil capsules 80 mg~ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage."
11059809|NCT01354691|OG001|Outcome|Placebo|"Placebo capsules~ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage."
11059810|NCT01354691|EG000|Reported Event|Ladostigil Hemitartrate|"Ladostigil capsules 80 mg~ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage."
11059811|NCT01354691|EG001|Reported Event|Placebo|"Placebo capsules~ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage."
11059812|NCT01354899|BG000|Baseline|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
11059813|NCT01354899|FG000|Participant Flow|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
11059814|NCT01354899|OG000|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
11059815|NCT01354899|EG000|Reported Event|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
10847100|NCT00281684|BG000|Baseline|Placebo|Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
11059816|NCT01354938|BG000|Baseline|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
11059817|NCT01354938|FG000|Participant Flow|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
11059818|NCT01354938|OG000|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
11059819|NCT01354938|EG000|Reported Event|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
11059820|NCT01354964|BG000|Baseline|Vitamin D|"Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to six months.~."
11059821|NCT01354964|BG001|Baseline|Placebo|Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months.
11059822|NCT01354964|BG002|Baseline|Total|Total of all reporting groups
11059823|NCT01354964|FG000|Participant Flow|Vitamin D|"Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to 6 months.~."
11059824|NCT01354964|FG001|Participant Flow|Placebo|Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months.
11059825|NCT01354964|OG000|Outcome|Vitamin D|Participants received weekly oral vitamin D drops using a weight-based calculated dosage to reach a target level of ≥30 ng/ml at second visit and a goal level of ≥50 ng/ml at third visit.
11059826|NCT01354964|OG001|Outcome|Placebo|Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D).
11059827|NCT01354964|OG001|Outcome|Placebo|Participants in this group were assigned to receive weekly oral placebo drops (similar in taste and appearance to vitamin D) for three months.
11059828|NCT01354964|OG000|Outcome|Vitamin D|"Participants in this group were assigned to receive weekly oral vitamin D drops using a weight-based calculated dosage for three months.~."
11059829|NCT01354964|EG000|Reported Event|Vitamin D|"Participants in this group were assigned to receive weekly oral vitamin D drops using a weight-based calculated dosage for six months.~."
11059830|NCT01354964|EG001|Reported Event|Placebo|Participants in this group were assigned to receive weekly oral placebo drops (similar in taste and appearance to vitamin D) for six months.
11059831|NCT01354990|BG000|Baseline|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
11059832|NCT01354990|FG000|Participant Flow|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
11059833|NCT01354990|OG000|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
10847101|NCT00281684|BG001|Baseline|SB705498 400 mg|Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
11059834|NCT01354990|EG000|Reported Event|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
11059835|NCT01355068|BG000|Baseline|Entire Study Population|Includes participants randomized to receive Epanutin (phenytoin) infatabs 50 mg first and Dilantin (phenytoin) infatabs 50 mg first.
11059836|NCT01355068|FG000|Participant Flow|Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 milligram (mg) chewable tablet in first intervention period; and single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
11059837|NCT01355068|FG001|Participant Flow|Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in first intervention period; and single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
11059838|NCT01355068|OG000|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
11059839|NCT01355068|OG001|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
11059840|NCT01355068|EG000|Reported Event|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
11059841|NCT01355068|EG001|Reported Event|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
11059842|NCT01355081|BG000|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
11059843|NCT01355081|BG001|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
11059844|NCT01355081|BG002|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
11059845|NCT01355081|BG003|Baseline|Total|Total of all reporting groups
11059846|NCT01355081|FG000|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
11059847|NCT01355081|FG001|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
11059848|NCT01355081|FG002|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
11059849|NCT01355081|OG000|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
11059850|NCT01355081|OG001|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
11059851|NCT01355081|OG002|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
11059852|NCT01355081|EG000|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
11059853|NCT01355081|EG001|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
11059854|NCT01355081|EG002|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
11059855|NCT01355159|BG000|Baseline|Folic Acid 4 mg|"Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid~Folic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid"
11059856|NCT01355159|BG001|Baseline|Placebo|"Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo~Placebo: Placebo x 4 tablets will be taken daily by oral administration."
11059857|NCT01355159|BG002|Baseline|Total|Total of all reporting groups
11059858|NCT01355159|FG000|Participant Flow|Folic Acid 4 mg|"Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid~Folic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid"
11059859|NCT01355159|FG001|Participant Flow|Placebo|"Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo~Placebo: Placebo x 4 tablets will be taken daily by oral administration."
11059860|NCT01355159|OG000|Outcome|Folic Acid 4 mg|"Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid~Folic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid"
11059861|NCT01355159|OG001|Outcome|Placebo|"Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo~Placebo: Placebo x 4 tablets will be taken daily by oral administration."
11059862|NCT01355159|EG000|Reported Event|Folic Acid 4 mg|"Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid~Folic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid"
11059863|NCT01355159|EG001|Reported Event|Placebo|"Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo~Placebo: Placebo x 4 tablets will be taken daily by oral administration."
11059864|NCT01355224|BG000|Baseline|No Risk Feedback|No risk feedback for obesity was provided.
11059865|NCT01355224|BG001|Baseline|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
11059866|NCT01355224|BG002|Baseline|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
11059867|NCT01355224|BG003|Baseline|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
11059868|NCT01355224|BG004|Baseline|Total|Total of all reporting groups
11059869|NCT01355224|FG000|Participant Flow|No Risk Feedback|No risk feedback for obesity was provided.
11059870|NCT01355224|FG001|Participant Flow|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
11059871|NCT01355224|FG002|Participant Flow|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
11059872|NCT01355224|FG003|Participant Flow|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
11059873|NCT01355224|OG000|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
11059874|NCT01355224|OG001|Outcome|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
11059875|NCT01355224|OG002|Outcome|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
11059876|NCT01355224|OG003|Outcome|Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
11059877|NCT01355224|OG001|Outcome|Low Genetic Risk Feedback|Genetic feedback arm; did not have elevated risk for obesity based on FTO alone.
11059878|NCT01355224|OG002|Outcome|High Genetic Risk Feedback|Genetic feedback arm; had elevated risk for obesity based on FTO alone.
11059879|NCT01355224|OG003|Outcome|Low Lifestyle Risk Feedback|Lifestyle feedback arm; did not have elevated risk for obesity based on lifestyle behavior alone.
11059880|NCT01355224|OG004|Outcome|High Lifestyle Risk Feedback|Lifestyle feedback arm; had elevated risk for obesity based on lifestyle behavior alone.
11059881|NCT01355224|OG001|Outcome|Low Genetic Risk + Low Lifestyle Risk Feedback|Feedback received: Did not have elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
11059882|NCT01355224|OG002|Outcome|Low Genetic Risk + High Lifestyle Risk Feedback|Feedback received: Did not have elevated risk for obesity based on FTO; had elevated risk for obesity based on lifestyle behavior.
11059883|NCT01355224|OG003|Outcome|High Genetic Risk + Low Lifestyle Risk Feedback|Feedback received: Had elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
11059884|NCT01355224|OG004|Outcome|High Genetic Risk + High Lifestyle Risk Feedback|Feedback received: Had elevated risk for obesity based on FTO; Had elevated risk for obesity based on lifestyle behavior.
11059885|NCT01355224|EG000|Reported Event|No Risk Feedback|Control arm - no obesity risk feedback provided
11059886|NCT01355224|EG001|Reported Event|Genetic Risk Feedback|FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.
11059887|NCT01355224|EG002|Reported Event|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
11059888|NCT01355224|EG003|Reported Event|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.~Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors."
11059889|NCT01355289|BG000|Baseline|Placebo (Core Study)|Placebo, was given orally for upto 21 days once daily.
11059890|NCT01355289|BG001|Baseline|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059891|NCT01355289|BG002|Baseline|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059892|NCT01355289|BG003|Baseline|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059893|NCT01355289|BG004|Baseline|Total|Total of all reporting groups
11059894|NCT01355289|FG000|Participant Flow|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
11059895|NCT01355289|FG001|Participant Flow|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059896|NCT01355289|FG002|Participant Flow|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059897|NCT01355289|FG003|Participant Flow|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059898|NCT01355289|FG004|Participant Flow|Avatrombopag (Open Label Extension)|Avatrombopag was initiated at a dose of 20 mg, once daily in the open label extension (OLE) period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
11059899|NCT01355289|OG000|Outcome|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
11059900|NCT01355289|OG001|Outcome|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059901|NCT01355289|OG002|Outcome|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days
11059902|NCT01355289|OG003|Outcome|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days
11059903|NCT01355289|OG002|Outcome|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059904|NCT01355289|OG003|Outcome|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059905|NCT01355289|EG000|Reported Event|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
11059906|NCT01355289|EG001|Reported Event|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059907|NCT01355289|EG002|Reported Event|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059908|NCT01355289|EG003|Reported Event|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
11059909|NCT01355289|EG004|Reported Event|Avatrombopag (Open Label Extension)|Avatrombopag was initiated at a dose of 20 mg, once daily in the open label extension (OLE) period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
11059910|NCT01355302|BG000|Baseline|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
11059911|NCT01355302|FG000|Participant Flow|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
11059912|NCT01355302|FG001|Participant Flow|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
11059913|NCT01355302|FG002|Participant Flow|Phase 2: Capecitabine + Cisplatin|Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes.
11059914|NCT01355302|OG000|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
11066835|NCT01393990|OG017|Outcome|Part D: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11149478|NCT01870999|BG002|Baseline|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149479|NCT01870999|BG003|Baseline|Total|Total of all reporting groups
11149480|NCT01870999|FG000|Participant Flow|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149481|NCT01870999|FG001|Participant Flow|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11059915|NCT01355302|OG000|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
11059916|NCT01355302|OG000|Outcome|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
11059917|NCT01355302|OG001|Outcome|Phase 2: Capecitabine + Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
11059918|NCT01355302|OG000|Outcome|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
11059919|NCT01355302|EG000|Reported Event|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
11059920|NCT01355419|BG000|Baseline|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
11059921|NCT01355419|FG000|Participant Flow|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
11059922|NCT01355419|OG000|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
11059923|NCT01355419|EG000|Reported Event|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
11059924|NCT01355458|BG000|Baseline|CD07805/47 Gel|
11059925|NCT01355458|BG001|Baseline|Placebo|
11059926|NCT01355458|BG002|Baseline|Total|Total of all reporting groups
11059927|NCT01355458|FG000|Participant Flow|CD07805/47 Gel|
11059928|NCT01355458|FG001|Participant Flow|Placebo|
11059929|NCT01355458|OG000|Outcome|CD07805/47 Gel|
11059930|NCT01355458|OG001|Outcome|Placebo|
11059931|NCT01355458|EG000|Reported Event|CD07805/47 Gel|
11059932|NCT01355458|EG001|Reported Event|Placebo|
11059933|NCT01355471|BG000|Baseline|CD07805/47 Gel|
11059934|NCT01355471|BG001|Baseline|Placebo|
11059935|NCT01355471|BG002|Baseline|Total|Total of all reporting groups
11059936|NCT01355471|FG000|Participant Flow|CD07805/47 Gel|
11059937|NCT01355471|FG001|Participant Flow|Placebo|
11059938|NCT01355471|OG000|Outcome|CD07805/47 Gel|
11059939|NCT01355471|OG001|Outcome|Placebo|
11059940|NCT01355471|EG000|Reported Event|CD07805/47 Gel|
11059941|NCT01355471|EG001|Reported Event|Placebo|
11059942|NCT01355484|BG000|Baseline|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
11059943|NCT01355484|BG001|Baseline|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
11059944|NCT01355484|BG002|Baseline|Total|Total of all reporting groups
11059945|NCT01355484|FG000|Participant Flow|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
11059946|NCT01355484|FG001|Participant Flow|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
11059947|NCT01355484|OG000|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
11059948|NCT01355484|OG001|Outcome|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
11059949|NCT01355484|EG000|Reported Event|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
11059950|NCT01355484|EG001|Reported Event|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
11059951|NCT01355497|BG000|Baseline|GTx-024|"subjects will be randomized to receive GTx-024 for the duration of the trail~GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial."
11059952|NCT01355497|BG001|Baseline|Placebo|"subjects will be randomized to receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
11059953|NCT01355497|BG002|Baseline|Total|Total of all reporting groups
11059954|NCT01355497|FG000|Participant Flow|GTx-024 3mg Once Daily|"subjects will be randomized to receive GTx-024 for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial."
11059955|NCT01355497|FG001|Participant Flow|Placebo|"subjects will be randomized to matching placebo once daily for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
11059956|NCT01355497|OG000|Outcome|GTx-024|"subjects will be randomized to receive GTx-024 for the duration of the trail~GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial."
11059957|NCT01355497|OG001|Outcome|Placebo|"subjects will be randomized to receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
11059958|NCT01355497|EG000|Reported Event|GTx-024 3mg Once Daily|"subjects will be randomized to receive GTx-024 for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial."
11059959|NCT01355497|EG001|Reported Event|Placebo Once Daily|"subjects will be randomized to receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
11059960|NCT01355523|BG000|Baseline|Melatonin|6 mg oral melatonin daily
11059961|NCT01355523|BG001|Baseline|Placebo|6 mg oral placebo daily
11059962|NCT01355523|BG002|Baseline|Total|Total of all reporting groups
11059963|NCT01355523|FG000|Participant Flow|Melatonin|6 mg oral melatonin daily
11059964|NCT01355523|FG001|Participant Flow|Placebo|6 mg oral placebo daily
11059965|NCT01355523|OG000|Outcome|Melatonin|6 mg oral melatonin daily
11059966|NCT01355523|OG001|Outcome|Placebo|6 mg oral placebo daily
11059967|NCT01355523|EG000|Reported Event|Melatonin|6 mg oral melatonin daily
11059968|NCT01355523|EG001|Reported Event|Placebo|6 mg oral placebo daily
11059969|NCT01355575|BG000|Baseline|Patients Combined|All patients in one group
11059970|NCT01355575|FG000|Participant Flow|Rifaximin for 6-weeks Then Standard Care|"Rifaximin for 6 weeks in addition to standard care, followed by 6 weeks observation period during which patients receive standard care.~Rifaximin: Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks."
11059971|NCT01355575|OG000|Outcome|Rifaximin for 6-weeks|Phase 1 Rifaximin: Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks.
11059972|NCT01355575|OG001|Outcome|Standard of Care for 6-weeks|Phase 2 The 6-weeks Rifaximin treatment was followed by an observation period for 6-weeks during which patients received standard of care. All patients who had received Rifaximin for 6-weeks then received standard of care for the 6-week period.
11059973|NCT01355575|OG000|Outcome|Rifaximin Baseline|Rifaximin baseline
11059974|NCT01355575|OG001|Outcome|Rifaximin After 6-weeks|Rifaximin: Patients received Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks.
11059975|NCT01355575|EG000|Reported Event|Rifaximin for 6-weeks|Participants received rifaximin tablet, oral administration, 400mg twice daily for 6-weeks.
11059976|NCT01355575|EG001|Reported Event|Standard of Care for 6-weeks|The 6-weeks Rifaximin treatment was followed by an observation period for 6-weeks during which patients received standard of care. All patients who had received Rifaximin for 6-weeks then received standard of care for the 6-week period.
11059977|NCT01355588|BG000|Baseline|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
11059978|NCT01355588|BG001|Baseline|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
11059979|NCT01355588|BG002|Baseline|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
11059980|NCT01355588|BG003|Baseline|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
11059981|NCT01355588|BG004|Baseline|Total|Total of all reporting groups
11059982|NCT01355588|FG000|Participant Flow|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
11059983|NCT01355588|FG001|Participant Flow|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
11059984|NCT01355588|FG002|Participant Flow|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
11059985|NCT01355588|FG003|Participant Flow|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
11059986|NCT01355588|OG000|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
11059987|NCT01355588|OG001|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
11059988|NCT01355588|OG002|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
11059989|NCT01355588|OG003|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
11059990|NCT01355588|EG000|Reported Event|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
11059991|NCT01355588|EG001|Reported Event|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
11059992|NCT01355588|EG002|Reported Event|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
11059993|NCT01355588|EG003|Reported Event|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
11059994|NCT01355627|BG000|Baseline|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
11059995|NCT01355627|BG001|Baseline|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
11059996|NCT01355627|BG002|Baseline|Total|Total of all reporting groups
11059997|NCT01355627|FG000|Participant Flow|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
11059998|NCT01355627|FG001|Participant Flow|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
11059999|NCT01355627|OG000|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
11060000|NCT01355627|OG001|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
11060001|NCT01355627|EG000|Reported Event|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
11060002|NCT01355627|EG001|Reported Event|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
11060003|NCT01355705|BG000|Baseline|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
11060004|NCT01355705|FG000|Participant Flow|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
11060005|NCT01355705|OG000|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
11060006|NCT01355705|OG000|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2~Amrubicin: 40, 60, or 80 mg/m2 intravenous (IV)~Lenalidomide: 15 mg daily by mouth~Dexamethasone: 40 mg weekly by mouth~Aspirin: 81 or 325 mg daily by mouth~Pegfilgrastim: 6 mg subcutaneous on Day 2"
11060007|NCT01355705|EG000|Reported Event|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
11066836|NCT01393990|OG000|Outcome|LY2228820|In Part A, participants received 10, 20, 40, 65, 90, 120, 160,or 200 mg LY2228820 in capsule form and 160, 200, 300, 420 or 560 mg LY2228820 in tablet form twice a day for Days 1 through 14 of 28-day cycles. In Part B participants received 420 mg LY2228820 tablets twice a day for Days 1 through 14 along with a single dose of 2 mg midazolam (on Days 1 and 8) in Cycle 1 of 28-day cycles. In Part C participants received 300 mg LY2228820 tablets twice a day on Days 1 through 14 of 28-day cycles. In Part D participants received 200 mg or 300 mg LY2228820 tablets twice a day on Days 1 through 14 of 28-day cycles and 20 mg tamoxifen on Days 1 through 28 of 28-day cycles. Part A bridging component tested the PK of capsule versus tablet formulation of LY2228820 and tablet was administered subsequently to all participants in the study.
10847102|NCT00281684|BG002|Baseline|SB705498 1000 mg|Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
11066837|NCT01393990|OG008|Outcome|Part A: 160 mg Bridge LY2228820|In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
11066838|NCT01393990|OG008|Outcome|Part A: 160 mg LY2228820 Tablets|160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066839|NCT01393990|OG009|Outcome|Part A: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066840|NCT01393990|OG010|Outcome|Part A and Part C: 300 mg LY2228820 Tablets|"Part A: 300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.~Part C: 300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met."
11066841|NCT01393990|OG011|Outcome|Part A and Part B: 420 mg LY2228820 Tablets|"Part A: 420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.~Part B: 420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1."
11066842|NCT01393990|OG012|Outcome|Part A: 560 mg LY2228820 Tablets|560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066843|NCT01393990|OG013|Outcome|Part D: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11066844|NCT01393990|OG014|Outcome|Part D: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11066845|NCT01393990|OG011|Outcome|Part A and Part B: 420 mg LY2228820 Tablets|"Part A: 420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.~Part B: 420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1."
11066846|NCT01393990|OG000|Outcome|Part A, C and D: LY2228820 300 mg Tablets|"Part A: 300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.~Part C: 300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.~Part D: 300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day."
11066847|NCT01393990|EG000|Reported Event|Part A: 10 mg LY2228820 Capsules|10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066848|NCT01393990|EG001|Reported Event|Part A: 20 mg LY2228820 Capsules|20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066849|NCT01393990|EG002|Reported Event|Part A: 40 mg LY2228820 Capsules|40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11060008|NCT01355796|BG000|Baseline|All Participants|Baseline characteristics of the entire study cohort
11060009|NCT01355796|FG000|Participant Flow|Xylitol First Then Saline|"Drug~Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 14 days Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day~Saline:~Hypersal: Hypertonic saline 7%, 4 ml twice a day for 14 days"
11060010|NCT01355796|FG001|Participant Flow|Saline First and Then Xylitol|"Aerosolized 7% hypertonic saline (4 ml) twice daily for 14 days~Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks~Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day"
11060011|NCT01355796|OG000|Outcome|Xylitol|"Drug~Aerosolized xylitol (5 ml) twice daily for 14 days~Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks, Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day"
11060012|NCT01355796|OG001|Outcome|Saline|Hypersal, 7%, 4 ml BID
11060013|NCT01355796|EG000|Reported Event|Aerosolized Hypertonic Xyltiol|"Drug~Aerosolized xylitol (5 ml) twice daily for 14 days~Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks~Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day"
11060014|NCT01355796|EG001|Reported Event|Hypertonic Saline|"Aerosolized 7% hypertonic saline (4 ml) twice daily for 14 days~Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks~Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day"
11060015|NCT01355978|BG000|Baseline|Noninvasive Open Ventilation System|Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System used during activities of daily living.
11060016|NCT01355978|FG000|Participant Flow|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
11060017|NCT01355978|OG000|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
11060018|NCT01355978|EG000|Reported Event|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
11060019|NCT01356147|BG000|Baseline|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
11060020|NCT01356147|BG001|Baseline|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
11060021|NCT01356147|BG002|Baseline|Total|Total of all reporting groups
11060022|NCT01356147|FG000|Participant Flow|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
11060023|NCT01356147|FG001|Participant Flow|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
11060024|NCT01356147|OG000|Outcome|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
11060025|NCT01356147|OG001|Outcome|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
11060026|NCT01356147|EG000|Reported Event|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
11060027|NCT01356147|EG001|Reported Event|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
11060028|NCT01356277|BG000|Baseline|Behavioral Intervention|"Participants in the intervention group form an Adherence Support Team (AST), receive standardized adherence education, and complete behavioral intervention at 3-month intervals. In between visits, the study facilitator will maintain monthly contact with participants via short phone or text-message check-ins. The electronic pillbox will collect adherence data and will be configured to provide visual cue or text message dose reminders to participants in the intervention group. Participants in the intervention group will be fed back their electronic adherence data at each study visit.~Action-focused problem-solving: An Adherence Support Team (AST), consisting of the patient, one or both parents (or primary caregiver), and the study facilitator, will be formed for each participant in the intervention arm. Action-focused problem-solving is informed by two complementary behavioral approaches: problem-solving and implementation intentions.~Implementation intentions are concrete"
11060029|NCT01356277|BG001|Baseline|Attention Control|Control participants will receive an electronic pillbox to measure medication adherence. They will meet with the study facilitator at 3-month intervals to discuss general health and life issues. The dose reminder functions of the electronic pillbox will not be enabled.
11060030|NCT01356277|BG002|Baseline|Total|Total of all reporting groups
11066850|NCT01393990|EG003|Reported Event|Part A: 65 mg LY2228820 Capsules|65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066851|NCT01393990|EG004|Reported Event|Part A: 90 mg LY2228820 Capsules|90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11060031|NCT01356277|FG000|Participant Flow|Behavioral Intervention|"Participants in the intervention group will form an Adherence Support Team (AST), receive standardized adherence education, and complete behavioral intervention at 3-month intervals. In between visits, the study facilitator will maintain monthly contact with participants via short phone or text-message check-ins. The electronic pillbox will collect adherence data and will be configured to provide visual cue or text message dose reminders to participants in the intervention group. Participants in the intervention group will be fed back their electronic adherence data at each study visit.~Action-focused problem-solving: An Adherence Support Team (AST), consisting of the patient, one or both parents (or primary caregiver), and the study facilitator, will be formed for each participant in the intervention arm. Action-focused problem-solving is informed by two complementary behavioral approaches: problem-solving and implementation intentions.~Implementation intentions are concrete"
11060032|NCT01356277|FG001|Participant Flow|Attention Control|Control participants will receive an electronic pillbox to measure medication adherence. They will meet with the study facilitator at 3-month intervals to discuss general health and life issues. The dose reminder functions of the electronic pillbox will not be enabled.
11060033|NCT01356277|OG000|Outcome|Behavioral Intervention|"The patient, parent and Coach formed an Adherence Support Team. The Coach delivered standardized education on immunosuppressive medications, identified adherence barriers using the AMBS/PMBS and the last 3 months of electronic monitoring data and then used 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient.~Action-focused problem-solving involved brainstorming possible solutions to a barrier, rating the potential solutions, and selecting one solution to implement following the session. The solution was concrete and took the form of an If/when…then… statement. Intervention participants could choose to receive text message, email, or visual cue dose reminders. At subsequent sessions the Coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 mo to identify adherence patterns and guide the development and revision of action plans."
11060034|NCT01356277|OG001|Outcome|Attention Control|Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
11060035|NCT01356277|OG000|Outcome|Behavioral Intervention|"Participants met with the coach at 3-month intervals. At each visit they had the opportunity to revise their Action plan or generate a new one. Action plans were concrete plans to address an adherence barrier that took the form When... then..."
11060036|NCT01356277|OG001|Outcome|Standard Care|Participants in the control group met with the coach at 3-month intervals but did not discuss adherence. They received general social support.
11060037|NCT01356277|EG000|Reported Event|Multi-component Intervention|"Adherence Support Team (patient, parent, Coach)~standardized education on immunosuppressive medications~identification of adherence barriers~Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals~'Action-Focused Problem-Solving' to address barriers selected as most important by the patient~text message, email, or visual cue dose reminders"
11060038|NCT01356277|EG001|Reported Event|Attention Control|"Electronic adherence monitoring~meetings with Coach at 3 month intervals"
11060039|NCT01356407|BG000|Baseline|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
11060040|NCT01356407|BG001|Baseline|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
10847103|NCT00281684|BG003|Baseline|Co-Codamol|Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
11060041|NCT01356407|BG002|Baseline|Total|Total of all reporting groups
11060042|NCT01356407|FG000|Participant Flow|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
11060043|NCT01356407|FG001|Participant Flow|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
11060044|NCT01356407|OG000|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
11060045|NCT01356407|OG001|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
11060046|NCT01356407|EG000|Reported Event|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
11060047|NCT01356407|EG001|Reported Event|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
11060048|NCT01356498|BG000|Baseline|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
11060049|NCT01356498|BG001|Baseline|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060050|NCT01356498|BG002|Baseline|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
11060051|NCT01356498|BG003|Baseline|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060052|NCT01356498|BG004|Baseline|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060053|NCT01356498|BG005|Baseline|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060054|NCT01356498|BG006|Baseline|Total|Total of all reporting groups
11060055|NCT01356498|FG000|Participant Flow|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
11060056|NCT01356498|FG001|Participant Flow|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060057|NCT01356498|FG002|Participant Flow|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
11060058|NCT01356498|FG003|Participant Flow|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060059|NCT01356498|FG004|Participant Flow|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060060|NCT01356498|FG005|Participant Flow|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060061|NCT01356498|OG000|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
11060062|NCT01356498|OG001|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060063|NCT01356498|OG002|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
11060064|NCT01356498|OG003|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060065|NCT01356498|OG004|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060066|NCT01356498|OG005|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
10847104|NCT00281684|BG004|Baseline|Total|Total of all reporting groups
11060067|NCT01356498|OG000|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
11060068|NCT01356498|OG001|Outcome|q4 RCT Responder|REsponder in Pegloticase every 4 wk arm of RCT, contuned to received pegloticase (q2 wk or q4 wk) in OLE
11060069|NCT01356498|OG002|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in RCT, initiated pegloticase treatment q2 wk in OLE
11060070|NCT01356498|OG003|Outcome|q2 RCT, Non-responder|Non-responder in pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
11060071|NCT01356498|OG004|Outcome|q4 RCT, Non-responder|Non-responder in Pegloticase every 4 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
11060072|NCT01356498|OG005|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in RCT, initiated pegloticase treatment q4 wk in OLE
11060073|NCT01356498|EG000|Reported Event|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
11060074|NCT01356498|EG001|Reported Event|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060075|NCT01356498|EG002|Reported Event|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
11060076|NCT01356498|EG003|Reported Event|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060077|NCT01356498|EG004|Reported Event|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060078|NCT01356498|EG005|Reported Event|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
11060079|NCT01356589|BG000|Baseline|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
11060080|NCT01356589|FG000|Participant Flow|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
11060081|NCT01356589|OG000|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
11060082|NCT01356589|EG000|Reported Event|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
11060083|NCT01356602|BG000|Baseline|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
11060084|NCT01356602|BG001|Baseline|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
11060085|NCT01356602|BG002|Baseline|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
11060086|NCT01356602|BG003|Baseline|Total|Total of all reporting groups
11060087|NCT01356602|FG000|Participant Flow|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
11060088|NCT01356602|FG001|Participant Flow|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
11060089|NCT01356602|FG002|Participant Flow|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
11060090|NCT01356602|OG000|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
11060091|NCT01356602|OG001|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
11060092|NCT01356602|OG002|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
11060093|NCT01356602|EG000|Reported Event|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
11060094|NCT01356602|EG001|Reported Event|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
11060095|NCT01356602|EG002|Reported Event|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
11060096|NCT01356628|BG000|Baseline|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
11060097|NCT01356628|FG000|Participant Flow|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
11060098|NCT01356628|OG000|Outcome|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
11060099|NCT01356628|EG000|Reported Event|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
11060100|NCT01356940|BG000|Baseline|Dalfampridine ER 10mg Bid Followed by Placebo|"• Age 18-75 inclusive, Male or Female 4 week administration of dalfampridine ER 10mg bid~Group A: dalfampridine ER 10mg bid for 4 weeks, 2 week washout, then matching placebo for 4 weeks"
11060101|NCT01356940|BG001|Baseline|Placebo Followed by Dalfampridine ER 10mg Bid|"• Age 18-75 inclusive, Male or Female identical placebo tablet administered bid for four weeks~Group B: identical placebo tablet administered bid for four weeks, 2 week washout, then dalfampridine ER 10mg bid for 4 weeks"
11060102|NCT01356940|BG002|Baseline|Total|Total of all reporting groups
11060103|NCT01356940|FG000|Participant Flow|Dalfampridine ER 10mg Bid- Placebo|4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo
11060104|NCT01356940|FG001|Participant Flow|Placebo-dalfampridine ER 10mg Bid|placebo tablet administered bid for four weeks followed by 2 week washout and dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
11060105|NCT01356940|OG000|Outcome|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
11060106|NCT01356940|OG001|Outcome|Placebo|"identical placebo tablet administered bid for four weeks~placebo: identical placebo tablet administered bid for four weeks"
11060107|NCT01356940|OG000|Outcome|Dalfampridine ER vs Baseline|"4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks~placebo: identical placebo tablet administered bid for four weeks"
11060108|NCT01356940|OG001|Outcome|Placebo vs Baseline|"placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks~placebo: identical placebo tablet administered bid for four weeks"
11060109|NCT01356940|EG000|Reported Event|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
11060110|NCT01356940|EG001|Reported Event|Placebo|"identical placebo tablet administered bid for four weeks~placebo: identical placebo tablet administered bid for four weeks"
11060111|NCT01356966|BG000|Baseline|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
11060112|NCT01356966|BG001|Baseline|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
11060113|NCT01356966|BG002|Baseline|Total|Total of all reporting groups
11060114|NCT01356966|FG000|Participant Flow|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
11060115|NCT01356966|FG001|Participant Flow|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
11060116|NCT01356966|OG000|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
11060117|NCT01356966|OG001|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
11060118|NCT01356966|EG000|Reported Event|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
11060119|NCT01356966|EG001|Reported Event|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
11060120|NCT01357135|BG000|Baseline|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
11060121|NCT01357135|BG001|Baseline|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
11060122|NCT01357135|BG002|Baseline|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
11060123|NCT01357135|BG003|Baseline|Total|Total of all reporting groups
11060124|NCT01357135|FG000|Participant Flow|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
11060125|NCT01357135|FG001|Participant Flow|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
11060126|NCT01357135|FG002|Participant Flow|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
11060127|NCT01357135|OG000|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
11060128|NCT01357135|OG001|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
11060129|NCT01357135|EG000|Reported Event|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
11060130|NCT01357135|EG001|Reported Event|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
11060131|NCT01357135|EG002|Reported Event|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
11060132|NCT01357148|BG000|Baseline|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
11060133|NCT01357148|FG000|Participant Flow|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
11060134|NCT01357148|OG000|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
11060135|NCT01357148|OG000|Outcome|Sitagliptin Phosphate/Metformin HCl|
11060136|NCT01357148|EG000|Reported Event|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
11060137|NCT01357161|BG000|Baseline|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
11060138|NCT01357161|BG001|Baseline|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
11060139|NCT01357161|BG002|Baseline|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
11060140|NCT01357161|BG003|Baseline|Total|Total of all reporting groups
11060141|NCT01357161|FG000|Participant Flow|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
11060142|NCT01357161|FG001|Participant Flow|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
11060143|NCT01357161|FG002|Participant Flow|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
11060144|NCT01357161|OG000|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
11060145|NCT01357161|OG001|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
11060146|NCT01357161|OG002|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
11060147|NCT01357161|EG000|Reported Event|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
11060148|NCT01357161|EG001|Reported Event|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
11060149|NCT01357161|EG002|Reported Event|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
11060150|NCT01357239|BG000|Baseline|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
11060151|NCT01357239|BG001|Baseline|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
11060152|NCT01357239|BG002|Baseline|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
11060153|NCT01357239|BG003|Baseline|Placebo|2 capsules of placebo per intake
11060154|NCT01357239|BG004|Baseline|Total|Total of all reporting groups
11060155|NCT01357239|FG000|Participant Flow|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
11060156|NCT01357239|FG001|Participant Flow|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
10847105|NCT00281684|FG000|Participant Flow|Placebo|Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
11060157|NCT01357239|FG002|Participant Flow|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
11060158|NCT01357239|FG003|Participant Flow|Placebo|2 capsules of placebo per intake
11060159|NCT01357239|OG000|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
11060160|NCT01357239|OG001|Outcome|Placebo|2 capsules of placebo per intake
11060161|NCT01357239|OG000|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
11060162|NCT01357239|OG001|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
11060163|NCT01357239|OG002|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
11060164|NCT01357239|OG003|Outcome|Placebo|2 capsules of placebo per intake
11060165|NCT01357239|OG002|Outcome|Placebo|2 capsules of placebo per intake
11060166|NCT01357239|EG000|Reported Event|Placebo|2 capsules of placebo per intake
11060167|NCT01357239|EG001|Reported Event|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
11060168|NCT01357239|EG002|Reported Event|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
11060169|NCT01357239|EG003|Reported Event|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
11060170|NCT01357356|BG000|Baseline|SER120 750 ng|All participants received SER120 750 ng once daily
11060171|NCT01357356|BG001|Baseline|SER120 1000 ng|All participants received SER120 1000 ng once daily
11060172|NCT01357356|BG002|Baseline|SER120 1500 ng|All participants received SER120 1500 ng once daily
11060173|NCT01357356|BG003|Baseline|Placebo|All participants received Placebo once daily
11060174|NCT01357356|BG004|Baseline|Total|Total of all reporting groups
11060175|NCT01357356|FG000|Participant Flow|SER120 750 ng|All participants received SER120 750 ng once daily
11060176|NCT01357356|FG001|Participant Flow|SER120 1000 ng|All participants received SER120 1000 ng once daily
11060177|NCT01357356|FG002|Participant Flow|SER120 1500 ng|All participants received SER120 1500 ng once daily
11060178|NCT01357356|FG003|Participant Flow|Placebo|All participants received Placebo once daily
11060179|NCT01357356|OG000|Outcome|SER120 750 ng|all participants received SER120 750 ng once daily
11060180|NCT01357356|OG001|Outcome|SER120 1000 ng|all participants received SER120 1000 ng once daily
11060181|NCT01357356|OG002|Outcome|SER120 1500 ng|all participants received SER120 1500 ng once daily
11060182|NCT01357356|OG003|Outcome|Placebo|all participants received placebo once daily
11060183|NCT01357356|OG000|Outcome|SER120 750 ng|All participants received SER120 750 ng once daily
11060184|NCT01357356|OG003|Outcome|Placebo|all participants received Placebo once daily
11060185|NCT01357356|EG000|Reported Event|SER120 750 ng|all participants received SER120 750 ng once daily
11060186|NCT01357356|EG001|Reported Event|SER120 1000 ng|all participants received SER120 1000 ng once daily
11060187|NCT01357356|EG002|Reported Event|SER120 1500 ng|all participants received SER120 1500 ng once daily
11060188|NCT01357356|EG003|Reported Event|Placebo|all participants received Placebo once daily
11060189|NCT01357512|BG000|Baseline|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
11060190|NCT01357512|BG001|Baseline|no MRI|No MRI before prostate biopsies
11060191|NCT01357512|BG002|Baseline|Total|Total of all reporting groups
10887129|NCT00498940|BG000|Baseline|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
11060192|NCT01357512|FG000|Participant Flow|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
11060193|NCT01357512|FG001|Participant Flow|no MRI|No MRI before prostate biopsies
11060194|NCT01357512|OG000|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
11060195|NCT01357512|OG001|Outcome|no MRI|No MRI before prostate biopsies
11060196|NCT01357512|EG000|Reported Event|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
11060197|NCT01357512|EG001|Reported Event|no MRI|No MRI before prostate biopsies
11060198|NCT01357525|BG000|Baseline|Stereotactic Body Radiotherapy|"Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:~12 Gy x 3 fractions (36 Gy total)"
11060199|NCT01357525|FG000|Participant Flow|Stereotactic Body Radiotherapy|"Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:~12 Gy x 3 fractions (36 Gy total)"
11060200|NCT01357525|OG000|Outcome|Stereotactic Body Radiotherapy|"Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:~12 Gy x 3 fractions (36 Gy total)"
11060201|NCT01357525|EG000|Reported Event|Stereotactic Body Radiotherapy|"Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:~12 Gy x 3 fractions (36 Gy total)"
11060202|NCT01357551|BG000|Baseline|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
11060203|NCT01357551|BG001|Baseline|Usual Care|Participants are randomized to receive usual care for 56 weeks
11060204|NCT01357551|BG002|Baseline|Total|Total of all reporting groups
11060205|NCT01357551|FG000|Participant Flow|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
11060206|NCT01357551|FG001|Participant Flow|Usual Care|Participants receive usual care for 56 weeks
11060207|NCT01357551|OG000|Outcome|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
11060208|NCT01357551|OG001|Outcome|Usual Care|Participants are randomized to receive usual care for 56 weeks
11060209|NCT01357551|OG000|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
11060210|NCT01357551|OG001|Outcome|Usual Care|Participants receive usual care for 56 weeks
11060211|NCT01357551|OG000|Outcome|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
11060212|NCT01357551|EG000|Reported Event|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Maintenance intervention: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
11060213|NCT01357551|EG001|Reported Event|Usual Care|Participants receive usual care for 56 weeks
11066852|NCT01393990|EG005|Reported Event|Part A: 120 mg LY2228820 Capsules|120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11060214|NCT01357564|BG000|Baseline|Tailored Activity Program|"Tailored intervention activity.~Tailored Activity Program: Intervention Protocol: In session #1, the interventionist, an occupational therapist (OT), meets with the caregiver and introduces the intervention goals. The OT provides and reviews a 3-ring binder which contains written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed will be a copy of Mace and Rabins' book, The 36 Hour Day. The OT will interview the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT will also observe interactions, noting communication and management style."
11060215|NCT01357564|BG001|Baseline|Attention Control|"Attention control.~Caregivers in this group receive bi-weekly telephone contact (up to 8 contacts) by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for managing the disease at home (Table 2). Each telephone contact is approximately 30 minutes in length and begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. Table 2 outlines the specific domain and session content that is covered. The attention control group intervention is delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers."
11060216|NCT01357564|BG002|Baseline|Total|Total of all reporting groups
11060217|NCT01357564|FG000|Participant Flow|Tailored Activity Program|"Intervention Group~Tailored Activity Program: Intervention Protocol: In session #1, the interventionist, an occupational therapist (OT), meets with the caregiver and introduces the intervention goals. The OT provides and reviews a 3-ring binder which contains written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed will be a copy of Mace and Rabins' book, The 36 Hour Day. The OT will interview the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT will also observe interactions, noting communication and management style. The OT will also meet with the Veteran, observe social capacity using the Peavy Comportment scale and administer the Dementia Rating Scale (DRS-2)."
11060218|NCT01357564|FG001|Participant Flow|Attention Control|Attention Control
11060219|NCT01357564|OG000|Outcome|Tailored Activity Program|The INT is designed to draw on residual abilities of Veterans with dementia and provide an environment supportive of these abilities. Occupational therapists assess the person's home environment, preserved capabilities, daily routines, interests and the caregiver's readiness and ability to use activities. Activities are developed that reflect the Veteran's previous or current interests and are modified to match their preserved capabilities without taxing the most impaired areas of cognition (e.g., memory, new learning). TAP-VA provides caregivers with the requisite knowledge and skills to use activities. Caregivers are instructed in specific skills such as ways to simplify activities, the environment and their communication, and how to help the Veteran initiate and follow a sequence. The overall goal is to provide predictability, familiarity, and structure in the daily life of the Veteran and establish a level of environmental stimulation appropriate to that person's abilities.
11060220|NCT01357564|OG001|Outcome|Attention Control|The ATN Serves 3 purposes: 1) creates clinical equipoise, ensuring that ethical treatment is provided to all study participants; 2) controls for the one-on-one attention to caregivers in the intervention group to rule out potential effects of professional contact; and 3) serves as a retention tool. Caregivers in this group receive bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for disease management. Each telephone contact begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. Table 2 outlines the specific domain and session content that is covered. The attention control group intervention is delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
11060221|NCT01357564|OG000|Outcome|Tailored Activity Intervention|Tailored Activity Program: Intervention
11060222|NCT01357564|OG001|Outcome|Attention Control|Phone calls/education
11060223|NCT01357564|EG000|Reported Event|Tailored Activity Program|The INT is designed to draw on residual abilities of Veterans with dementia and provide an environment supportive of these abilities. Occupational therapists assess the person's home environment, preserved capabilities, daily routines, interests and the caregiver's readiness and ability to use activities. Activities are developed that reflect the Veteran's previous or current interests and are modified to match their preserved capabilities without taxing the most impaired areas of cognition (e.g., memory, new learning). TAP-VA provides caregivers with the requisite knowledge and skills to use activities. Caregivers are instructed in specific skills such as ways to simplify activities, the environment and their communication, and how to help the Veteran initiate and follow a sequence. The overall goal is to provide predictability, familiarity, and structure in the daily life of the Veteran and establish a level of environmental stimulation appropriate to that person's abilities.
11060224|NCT01357564|EG001|Reported Event|Attention Control|The ATN Serves 3 purposes: 1) creates clinical equipoise, ensuring that ethical treatment is provided to all study participants; 2) controls for the one-on-one attention to caregivers in the intervention group to rule out potential effects of professional contact; and 3) serves as a retention tool. Caregivers in this group receive bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for disease management. Each telephone contact begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. Table 2 outlines the specific domain and session content that is covered. The attention control group intervention is delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
11066853|NCT01393990|EG006|Reported Event|Part A: 160 mg LY2228820 Capsules|160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11060225|NCT01357577|BG000|Baseline|Cognitive Behavioral Therapy + Treatment as Usual|"The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).~Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals."
11060226|NCT01357577|BG001|Baseline|Treatment as Usual|"The no intervention group will receive treatment as usual (TAU) without additional individual treatment.."
11060227|NCT01357577|BG002|Baseline|Total|Total of all reporting groups
11060228|NCT01357577|FG000|Participant Flow|Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU)|"The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).~Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals."
11060229|NCT01357577|FG001|Participant Flow|Treatment as Usual (TAU)|"The no intervention group will receive treatment as usual (TAU)."
11060230|NCT01357577|OG000|Outcome|Cognitive Behavioral Therapy + Treatment as Usual|"The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).~Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals."
11060231|NCT01357577|OG001|Outcome|Treatment as Usual|"The no intervention group will receive treatment as usual (TAU) without additional treatment."
11060232|NCT01357577|OG001|Outcome|Treatment as Usual|"The no intervention group will receive treatment as usual (TAU) without additional individual treatment.."
11060233|NCT01357577|EG000|Reported Event|Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU)|"The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).~Cognitive behavioral therapy for PTSD: The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals."
11060234|NCT01357577|EG001|Reported Event|Treatment as Usual (TAU)|"The no intervention group will receive treatment as usual (TAU)."
11060235|NCT01357616|BG000|Baseline|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
11060236|NCT01357616|BG001|Baseline|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
11060237|NCT01357616|BG002|Baseline|Total|Total of all reporting groups
11060238|NCT01357616|FG000|Participant Flow|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
11060239|NCT01357616|FG001|Participant Flow|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
11060240|NCT01357616|OG000|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
11060241|NCT01357616|OG001|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
11060242|NCT01357616|EG000|Reported Event|AZARGA (Test Group)|"Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension"
11060243|NCT01357616|EG001|Reported Event|AZOPT + TIMOLOL (Control Group)|"Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution"
11060244|NCT01357655|BG000|Baseline|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
11060245|NCT01357655|BG001|Baseline|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
11060246|NCT01357655|BG002|Baseline|Total|Total of all reporting groups
11060247|NCT01357655|FG000|Participant Flow|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
11060248|NCT01357655|FG001|Participant Flow|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
11060249|NCT01357655|OG000|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
11060250|NCT01357655|OG001|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
11060251|NCT01357655|EG000|Reported Event|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, Once daily, approximately 1 year
11060252|NCT01357720|BG000|Baseline|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
11060253|NCT01357720|BG001|Baseline|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
11060254|NCT01357720|BG002|Baseline|Total|Total of all reporting groups
11060255|NCT01357720|FG000|Participant Flow|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
11060256|NCT01357720|FG001|Participant Flow|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
10847106|NCT00281684|FG001|Participant Flow|SB705498 400 mg|Eligible participants received a single dose of SB705498 400 milligram (mg) capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
11060257|NCT01357720|OG000|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
11060258|NCT01357720|OG001|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
11060259|NCT01357720|EG000|Reported Event|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
11060260|NCT01357720|EG001|Reported Event|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
11060261|NCT01357850|BG000|Baseline|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060262|NCT01357850|BG001|Baseline|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060263|NCT01357850|BG002|Baseline|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060264|NCT01357850|BG003|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060265|NCT01357850|BG004|Baseline|Total|Total of all reporting groups
11060266|NCT01357850|FG000|Participant Flow|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060267|NCT01357850|FG001|Participant Flow|Albiglutide 3.75 mg|Participants received albiglutide 3.75 milligrams (mg) weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060268|NCT01357850|FG002|Participant Flow|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060269|NCT01357850|FG003|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060270|NCT01357850|OG000|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060271|NCT01357850|OG001|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060272|NCT01357850|OG002|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060273|NCT01357850|OG003|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060274|NCT01357850|OG001|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060275|NCT01357850|EG000|Reported Event|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060276|NCT01357850|EG001|Reported Event|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060277|NCT01357850|EG002|Reported Event|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060278|NCT01357850|EG003|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060279|NCT01357889|BG000|Baseline|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
11060280|NCT01357889|BG001|Baseline|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
11060281|NCT01357889|BG002|Baseline|Total|Total of all reporting groups
11341979|NCT03694548|FG000|Participant Flow|Part A Survey Adolescent Patients With SCD and Chronic Pain (Group 1)|"Adolescent patients with Sickle Cell Disease (SCD) and chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD.~Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD."
11060282|NCT01357889|FG000|Participant Flow|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
11060283|NCT01357889|FG001|Participant Flow|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
10847107|NCT00281684|FG002|Participant Flow|SB705498 1000 mg|Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
11060284|NCT01357889|OG000|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
11060285|NCT01357889|OG001|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
11060286|NCT01357889|OG000|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060287|NCT01357889|OG001|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
11060288|NCT01357889|EG000|Reported Event|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
11060289|NCT01357889|EG001|Reported Event|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
11060290|NCT01357915|BG000|Baseline|GSK149203A S- Group|Healthy male subjects who received 3 doses of GSK Biologicals' candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
11060291|NCT01357915|BG001|Baseline|GSK149203A S+ Group|Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
11060292|NCT01357915|BG002|Baseline|Total|Total of all reporting groups
11060293|NCT01357915|FG000|Participant Flow|GSK149203A S- Group|Healthy male subjects who received 3 doses of GSK Biologicals' candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
11060294|NCT01357915|FG001|Participant Flow|GSK149203A S+ Group|Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
11226731|NCT02377674|FG000|Participant Flow|Vascular Graft, Model COR-VG-001|"A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.~Vascular Graft, Model COR-VG-001: The intended use of the Xeltis Vascular Graft, Model COR-VG-001 is to create an extracardiac total cavopulmonary connection (EC-TCPC) connection to divert the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle reducing the volume load on the functional single ventricle and thereby improving hemodynamics by minimizing the deleterious effects of ventricular hypertrophy."
11226732|NCT02377674|OG000|Outcome|Vascular Graft, Model COR-VG-001|"A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.~Vascular Graft, Model COR-VG-001: The intended use of the Xeltis Vascular Graft, Model COR-VG-001 is to create an extracardiac total cavopulmonary connection (EC-TCPC) connection to divert the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle reducing the volume load on the functional single ventricle and thereby improving hemodynamics by minimizing the deleterious effects of ventricular hypertrophy."
11060295|NCT01357915|OG000|Outcome|GSK149203A S- Group|Healthy male subjects who received 3 doses of GSK Biologicals' candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
11060296|NCT01357915|OG001|Outcome|GSK149203A S+ Group|Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
11060297|NCT01357915|EG000|Reported Event|GSK149203A S- Group|Healthy male subjects who received 3 doses of GSK Biologicals' candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
11060298|NCT01357915|EG001|Reported Event|GSK149203A S+ Group|Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
11226733|NCT02377674|EG000|Reported Event|Vascular Graft, Model COR-VG-001|"A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.~Vascular Graft, Model COR-VG-001: The intended use of the Xeltis Vascular Graft, Model COR-VG-001 is to create an extracardiac total cavopulmonary connection (EC-TCPC) connection to divert the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle reducing the volume load on the functional single ventricle and thereby improving hemodynamics by minimizing the deleterious effects of ventricular hypertrophy."
11226734|NCT02377700|BG000|Baseline|Xeltis Vascular Patch, Model COR-VP-001|"Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.~Xeltis Vascular Patch, Model COR-VP-001: The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis"
11226735|NCT02377700|FG000|Participant Flow|Xeltis Vascular Patch, Model COR-VP-001|"Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.~Xeltis Vascular Patch, Model COR-VP-001: The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis"
11226736|NCT02377700|OG000|Outcome|Xeltis Vascular Patch, Model COR-VP-001|"Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.~Xeltis Vascular Patch, Model COR-VP-001: The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis"
11060299|NCT01357980|BG000|Baseline|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
11060300|NCT01357980|BG001|Baseline|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
11060301|NCT01357980|BG002|Baseline|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
11060302|NCT01357980|BG003|Baseline|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
11060303|NCT01357980|BG004|Baseline|Total|Total of all reporting groups
11226737|NCT02377700|EG000|Reported Event|Xeltis Vascular Patch, Model COR-VP-001|"Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.~Xeltis Vascular Patch, Model COR-VP-001: The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis"
11226738|NCT02377752|BG000|Baseline|Part A Cohort 1: Olaratumab+Doxorubicin|15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11060304|NCT01357980|FG000|Participant Flow|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
11060305|NCT01357980|FG001|Participant Flow|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
11060306|NCT01357980|FG002|Participant Flow|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
11060307|NCT01357980|FG003|Participant Flow|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
11060308|NCT01357980|OG000|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
11060309|NCT01357980|OG001|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
11060310|NCT01357980|OG002|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
11060311|NCT01357980|OG003|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
11060312|NCT01357980|EG000|Reported Event|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
11060313|NCT01357980|EG001|Reported Event|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
11060314|NCT01357980|EG002|Reported Event|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
11060315|NCT01357980|EG003|Reported Event|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
11060316|NCT01358175|BG000|Baseline|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11060317|NCT01358175|BG001|Baseline|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11060318|NCT01358175|BG002|Baseline|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
11060319|NCT01358175|BG003|Baseline|Total|Total of all reporting groups
11060320|NCT01358175|FG000|Participant Flow|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11060321|NCT01358175|FG001|Participant Flow|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11060322|NCT01358175|FG002|Participant Flow|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
11060323|NCT01358175|OG000|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11060324|NCT01358175|OG001|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11060325|NCT01358175|OG002|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
11060326|NCT01358175|EG000|Reported Event|Secukinumab 10mg/kg -75 mg|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11060327|NCT01358175|EG001|Reported Event|Secukinumab 10mg/kg -150 mg|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11060328|NCT01358175|EG002|Reported Event|Placebo Secukinumab|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 up to end of Study
11060329|NCT01358175|EG003|Reported Event|Placebo Non-Resp Secukinumab 75 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 75 mg
11060330|NCT01358175|EG004|Reported Event|Placebo Non-Resp Secukinumab 150 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 150 mg
11060331|NCT01358175|EG005|Reported Event|Placebo Resp Secukinumab 75 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 75 mg
11060332|NCT01358175|EG006|Reported Event|Placebo Resp Secukinumab 150 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 150 mg
11060333|NCT01358266|BG000|Baseline|DE-109 44 µg|Double Masked Phase Low Dose 44 µg Open Label Phase High Dose 880 µg
11060334|NCT01358266|BG001|Baseline|DE-109 440 µg|Double Masked Phase Medium Dose 440 µg Open Label Phase High Dose 880 µg
11060335|NCT01358266|BG002|Baseline|DE-109 880 µg|Double Masked Phase High Dose 880 µg Open Label Phase High Dose 880 µg
11060336|NCT01358266|BG003|Baseline|Total|Total of all reporting groups
11060337|NCT01358266|FG000|Participant Flow|DE-109 44 μg|SAKURA Study 1 & Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 & Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4
11060338|NCT01358266|FG001|Participant Flow|DE-109 440 μg|SAKURA Study 1 & Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 & Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4
11060339|NCT01358266|FG002|Participant Flow|DE-109 880 μg|"SAKURA Study 1 & Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 & Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4~Open-Label Treatment Period Injection on Month 6, Month 8, Month 10 Open-Label Re-Treatment Period May receive up to 6 injections PRN through Month 22 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4"
11060340|NCT01358266|OG000|Outcome|DE-109 44 µg|Low Dose DE-109 44 µg
11060341|NCT01358266|OG001|Outcome|DE-109 440 µg|Medium Dose DE-109 440 µg
11060342|NCT01358266|OG002|Outcome|DE-109 880 µg|High Dose DE-109 880 µg
11060343|NCT01358266|EG000|Reported Event|DE-109 44 µg - Double Masked|Double Masked Phase Low Dose 44 µg
11060344|NCT01358266|EG001|Reported Event|DE-109 440 µg - Double Masked|Double Masked Phase Medium Dose 440 µg
11060345|NCT01358266|EG002|Reported Event|DE-109 880 µg - Double Masked|Double Masked Phase High Dose 880 µg
11060346|NCT01358266|EG003|Reported Event|DE-109 880 µg - Open-Label|Open-label Phase High Dose 880 µg
11060347|NCT01358331|BG000|Baseline|MK-8353 100 mg Twice Daily (BID)|Participants received 100 mg twice daily for 28 days during each cycle
11060348|NCT01358331|BG001|Baseline|MK-8353 200 mg BID|Participants received 200 mg twice daily for 28 days during each cycle
11060349|NCT01358331|BG002|Baseline|MK-8353 300 mg BID|Participants received 300 mg twice daily for 28 days during each cycle
11060350|NCT01358331|BG003|Baseline|MK-8353 350 mg BID|Participants received 350 mg twice daily for 28 days during each cycle
11060351|NCT01358331|BG004|Baseline|MK-8353 400 mg BID|Participants received 400 mg twice daily for 28 days during each cycle
11060352|NCT01358331|BG005|Baseline|MK-8353 800 mg BID|Participants received 800 mg twice daily for 28 days during each cycle
11060353|NCT01358331|BG006|Baseline|Total|Total of all reporting groups
11060354|NCT01358331|FG000|Participant Flow|MK-8353 100 mg Twice Daily (BID)|Participants received 100 mg twice daily for 28 days during each cycle
11060355|NCT01358331|FG001|Participant Flow|MK-8353 200 mg BID|Participants received 200 mg twice daily for 28 days during each cycle
11060356|NCT01358331|FG002|Participant Flow|MK-8353 300 mg BID|Participants received 300 mg twice daily for 28 days during each cycle
11060357|NCT01358331|FG003|Participant Flow|MK-8353 350 mg BID|Participants received 350 mg twice daily for 28 days during each cycle
11060358|NCT01358331|FG004|Participant Flow|MK-8353 400 mg BID|Participants received 400 mg twice daily for 28 days during each cycle
11060359|NCT01358331|FG005|Participant Flow|MK-8353 800 mg BID|Participants received 800 mg twice daily for 28 days during each cycle
11060360|NCT01358331|OG000|Outcome|MK-8353 100 mg Twice Daily (BID)|Participants received 100 mg twice daily for 28 days during each cycle
11060361|NCT01358331|OG001|Outcome|MK-8353 200 mg BID|Participants received 200 mg twice daily for 28 days during each cycle
11060362|NCT01358331|OG002|Outcome|MK-8353 300 mg BID|Participants received 300 mg twice daily for 28 days during each cycle
11060363|NCT01358331|OG003|Outcome|MK-8353 350 mg BID|Participants received 350 mg twice daily for 28 days during each cycle
11060364|NCT01358331|OG004|Outcome|MK-8353 400 mg BID|Participants received 400 mg twice daily for 28 days during each cycle
11060365|NCT01358331|OG005|Outcome|MK-8353 800 mg BID|Participants received 800 mg twice daily for 28 days during each cycle
11060366|NCT01358331|EG000|Reported Event|MK-8353 100 mg Twice Daily (BID)|Participants received 100 mg twice daily for 28 days during each cycle
11060367|NCT01358331|EG001|Reported Event|MK-8353 200 mg BID|Participants received 200 mg twice daily for 28 days during each cycle
11060368|NCT01358331|EG002|Reported Event|MK-8353 300 mg BID|Participants received 300 mg twice daily for 28 days during each cycle
11060369|NCT01358331|EG003|Reported Event|MK-8353 350 mg BID|Participants received 350 mg twice daily for 28 days during each cycle
11060370|NCT01358331|EG004|Reported Event|MK-8353 400 mg BID|Participants received 400 mg twice daily for 28 days during each cycle
11060371|NCT01358331|EG005|Reported Event|MK-8353 800 mg BID|Participants received 800 mg twice daily for 28 days during each cycle
11060372|NCT01358357|BG000|Baseline|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
11060373|NCT01358357|BG001|Baseline|Placebo|Placebo: 20-80 mg flexible dose
11060374|NCT01358357|BG002|Baseline|Total|Total of all reporting groups
11060375|NCT01358357|FG000|Participant Flow|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
11060376|NCT01358357|FG001|Participant Flow|Placebo|Placebo: 20-80 mg flexible dose
11060377|NCT01358357|FG002|Participant Flow|All Subjects|During the Open-label stabilization phase, subjects received flexible does of lurasidone 20 - 80 mg daily.
11060378|NCT01358357|OG000|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
11060379|NCT01358357|OG001|Outcome|Placebo|Placebo: 20-80 mg flexible dose
11060380|NCT01358357|EG000|Reported Event|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
11060381|NCT01358357|EG001|Reported Event|Placebo|Placebo: 20-80 mg flexible dose
11060382|NCT01358357|EG002|Reported Event|All Subjects|During the open-label stabilization phase, subjects received flexible does of lurasidone 20-80 mg daily
11060383|NCT01358526|BG000|Baseline|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
11060384|NCT01358526|BG001|Baseline|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
11060385|NCT01358526|BG002|Baseline|Total|Total of all reporting groups
11060386|NCT01358526|FG000|Participant Flow|Open-label Titration OXN|The open-label titration was designed to identify a stable, effective, and tolerable dose of OXN for each subject.
11060387|NCT01358526|FG001|Participant Flow|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
11060388|NCT01358526|FG002|Participant Flow|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
11060389|NCT01358526|OG000|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
11060390|NCT01358526|OG001|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
11060391|NCT01358526|EG000|Reported Event|Open-label Titration OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
11060392|NCT01358526|EG001|Reported Event|Double-blind Placebo|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
11060393|NCT01358526|EG002|Reported Event|Double-blind OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
11060394|NCT01358578|BG000|Baseline|AIN457 150mg|AIN457 150mg
11060395|NCT01358578|BG001|Baseline|AIN457 300mg|AIN457 300mg
11060396|NCT01358578|BG002|Baseline|Placebo|Placebo
11060397|NCT01358578|BG003|Baseline|Etanercept|Etanercept
11060398|NCT01358578|BG004|Baseline|Total|Total of all reporting groups
11060399|NCT01358578|FG000|Participant Flow|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
11060400|NCT01358578|FG001|Participant Flow|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
11060401|NCT01358578|FG002|Participant Flow|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
11060402|NCT01358578|FG003|Participant Flow|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.~injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
11060403|NCT01358578|FG004|Participant Flow|AIN457 150mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
11060404|NCT01358578|FG005|Participant Flow|AIN457 300mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
11060405|NCT01358578|OG000|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
11060406|NCT01358578|OG001|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
11060407|NCT01358578|OG002|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
11060408|NCT01358578|OG002|Outcome|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.~injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
11060409|NCT01358578|OG003|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
11060410|NCT01358578|OG002|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
11060411|NCT01358578|OG002|Outcome|Placebo|AIN457A exact match Placebo
11060412|NCT01358578|OG002|Outcome|Etanercept|etanercept 50 mg twice per week until Week 12
11060413|NCT01358578|OG002|Outcome|PLACEBO-150 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
11060414|NCT01358578|OG003|Outcome|PLACEBO-300 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
11060415|NCT01358578|OG004|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
11060416|NCT01358578|OG005|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
11060417|NCT01358578|EG000|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
11060418|NCT01358578|EG001|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
11060419|NCT01358578|EG002|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
11060420|NCT01358578|EG003|Reported Event|INDUCTION-Etanercept|INDUCTION-Etanercept
11060421|NCT01358578|EG004|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
11060422|NCT01358578|EG005|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
11060423|NCT01358578|EG006|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
11060424|NCT01358578|EG007|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
11060425|NCT01358578|EG008|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
11060426|NCT01358578|EG009|Reported Event|ENTIRE-Etanercept|ENTIRE-Etanercept
11060427|NCT01358578|EG010|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
11060428|NCT01358578|EG011|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
11060429|NCT01358578|EG012|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
11060430|NCT01358578|EG013|Reported Event|FOLLOW UP-Etanercept|FOLLOW UP-Etanercept
11060431|NCT01358708|BG000|Baseline|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060432|NCT01358708|BG001|Baseline|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060433|NCT01358708|BG002|Baseline|Total|Total of all reporting groups
11060434|NCT01358708|FG000|Participant Flow|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060435|NCT01358708|FG001|Participant Flow|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060436|NCT01358708|OG000|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060437|NCT01358708|OG001|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060438|NCT01358708|OG000|Outcome|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060439|NCT01358708|OG001|Outcome|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060440|NCT01358708|OG002|Outcome|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060441|NCT01358708|EG000|Reported Event|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060442|NCT01358708|EG001|Reported Event|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060443|NCT01358708|EG002|Reported Event|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
11060444|NCT01358721|BG000|Baseline|Nivolumab 0.3 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060445|NCT01358721|BG001|Baseline|Nivolumab 2 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060446|NCT01358721|BG002|Baseline|Nivolumab 10 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060447|NCT01358721|BG003|Baseline|Nivolumab 10 mg/kg (Treatment-naive)|Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060448|NCT01358721|BG004|Baseline|Total|Total of all reporting groups
11060449|NCT01358721|FG000|Participant Flow|Nivolumab 0.3 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060450|NCT01358721|FG001|Participant Flow|Nivolumab 2 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060451|NCT01358721|FG002|Participant Flow|Nivolumab 10 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060452|NCT01358721|FG003|Participant Flow|Nivolumab 10 mg/kg (Treatment-naive)|Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060453|NCT01358721|OG000|Outcome|Nivolumab 0.3 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060454|NCT01358721|OG001|Outcome|Nivolumab 2 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060455|NCT01358721|OG002|Outcome|Nivolumab 10 mg/kg (Previously-treated)|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060456|NCT01358721|OG003|Outcome|Nivolumab 10 mg/kg (Treatment-naive)|Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060457|NCT01358721|EG000|Reported Event|BMS 0.3 mg/kg|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060458|NCT01358721|EG001|Reported Event|BMS 2 mg/kg|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060459|NCT01358721|EG002|Reported Event|BMS 10 mg/kg|Nivolumab was administered as a 60 minute IV infusion to participants who were previously treated with at least one anti-angiogenic therapy. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060460|NCT01358721|EG003|Reported Event|BMS 10 mg/Kg-N|Nivolumab was administered as a 60 minute IV infusion to treatment-naive participants. Participants were dosed every 3 weeks until discontinuation or the end of the study.
11060461|NCT01358734|BG000|Baseline|Lenalidomide|Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
11060462|NCT01358734|BG001|Baseline|Azacitidine + Lenalidomide|Participants received azacitidine 75 mg/m^2/ daily SC on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care
11060463|NCT01358734|BG002|Baseline|Azacitidine|Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
11060464|NCT01358734|BG003|Baseline|Total|Total of all reporting groups
11060465|NCT01358734|FG000|Participant Flow|Lenalidomide|Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
11060466|NCT01358734|FG001|Participant Flow|Azacitidine Plus Lenalidomide|Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
11060467|NCT01358734|FG002|Participant Flow|Azacitidine|Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
11060468|NCT01358734|OG000|Outcome|Lenalidomide|Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
11060469|NCT01358734|OG001|Outcome|Azacitidine Plus Lenalidomide|Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
11226739|NCT02377752|BG001|Baseline|Part A Cohort 2: Olaratumab+Doxorubicin|15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11226740|NCT02377752|BG002|Baseline|Part A Cohort 3 Olaratumab + Doxorubicin|20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11060470|NCT01358734|OG002|Outcome|Azacitidine|Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
11060471|NCT01358734|EG000|Reported Event|Lenalidomide|Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
11060472|NCT01358734|EG001|Reported Event|Azacitidine Plus Lenalidomide|Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
11060473|NCT01358734|EG002|Reported Event|Azacitidine|Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
11060474|NCT01358760|BG000|Baseline|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060475|NCT01358760|BG001|Baseline|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060476|NCT01358760|BG002|Baseline|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060477|NCT01358760|BG003|Baseline|Total|Total of all reporting groups
11060478|NCT01358760|FG000|Participant Flow|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060479|NCT01358760|FG001|Participant Flow|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11226741|NCT02377752|BG003|Baseline|Part B: Olaratumab|15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11060480|NCT01358760|FG002|Participant Flow|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060481|NCT01358760|OG000|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060482|NCT01358760|OG001|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11226742|NCT02377752|BG004|Baseline|Total|Total of all reporting groups
11060483|NCT01358760|OG002|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060484|NCT01358760|EG000|Reported Event|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060485|NCT01358760|EG001|Reported Event|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060486|NCT01358760|EG002|Reported Event|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
11060487|NCT01358825|BG000|Baseline|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
11060488|NCT01358825|BG001|Baseline|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
11060489|NCT01358825|BG002|Baseline|Total|Total of all reporting groups
11060490|NCT01358825|FG000|Participant Flow|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
11226743|NCT02377752|FG000|Participant Flow|Part A Cohort 1: Olaratumab+Doxorubicin|15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met
11149482|NCT01870999|FG002|Participant Flow|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149483|NCT01870999|OG000|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149484|NCT01870999|OG001|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149485|NCT01870999|OG002|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149486|NCT01870999|EG000|Reported Event|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149487|NCT01870999|EG001|Reported Event|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149488|NCT01870999|EG002|Reported Event|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
11149489|NCT01871077|BG000|Baseline|PRO-156|"Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.~PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days."
11149490|NCT01871077|FG000|Participant Flow|PRO-156|"Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.~PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days."
11149491|NCT01871077|OG000|Outcome|PRO-156|"Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.~PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days."
11149492|NCT01871077|EG000|Reported Event|PRO-156|"Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.~PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days."
11149493|NCT01871090|BG000|Baseline|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
11149494|NCT01871090|BG001|Baseline|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
11149495|NCT01871090|BG002|Baseline|Total|Total of all reporting groups
11149496|NCT01871090|FG000|Participant Flow|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
11149497|NCT01871090|FG001|Participant Flow|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
11149498|NCT01871090|OG000|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
11149499|NCT01871090|OG001|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
11149500|NCT01871090|EG000|Reported Event|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
11149501|NCT01871090|EG001|Reported Event|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
11149502|NCT01871142|BG000|Baseline|Entire Study Population|All enrolled participant baseline data
11149503|NCT01871142|FG000|Participant Flow|Randomized Crossover Assignment|Participants will receive, in a random order, a placebo prior to exercise in normoxia, a placebo prior to exercise in hypoxia, 1000 mg of Aes-103 prior to exercise in hypoxia, and 3000 mg of Aes-103 prior to exercise in hypoxia. Each intervention is separated by a 7 day washout period.
11149504|NCT01871142|OG000|Outcome|Palcebo + Normoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
11149505|NCT01871142|OG001|Outcome|Placebo + Hypoxia|"Randomized crossover assignment for each participant.~Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% Oxygen)"
11149506|NCT01871142|OG002|Outcome|1000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant.~Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
11149507|NCT01871142|OG003|Outcome|3000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
11149508|NCT01871142|OG000|Outcome|Placebo + Normoxia|"Number of participants receiving placebo in normoxic conditions. Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
11060491|NCT01358825|FG001|Participant Flow|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
11060492|NCT01358825|OG000|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
11060493|NCT01358825|OG001|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
11060494|NCT01358825|EG000|Reported Event|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
11060495|NCT01358825|EG001|Reported Event|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
11060496|NCT01358864|BG000|Baseline|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
11060497|NCT01358864|BG001|Baseline|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
11060498|NCT01358864|BG002|Baseline|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
11060499|NCT01358864|BG003|Baseline|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
11060500|NCT01358864|BG004|Baseline|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060501|NCT01358864|BG005|Baseline|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
10887130|NCT00498940|BG001|Baseline|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
10887131|NCT00498940|BG002|Baseline|Total|Total of all reporting groups
11060502|NCT01358864|BG006|Baseline|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060503|NCT01358864|BG007|Baseline|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060504|NCT01358864|BG008|Baseline|Total|Total of all reporting groups
11060505|NCT01358864|FG000|Participant Flow|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
11060506|NCT01358864|FG001|Participant Flow|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
11060507|NCT01358864|FG002|Participant Flow|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
11060508|NCT01358864|FG003|Participant Flow|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
11060509|NCT01358864|FG004|Participant Flow|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060510|NCT01358864|FG005|Participant Flow|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060511|NCT01358864|FG006|Participant Flow|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060512|NCT01358864|FG007|Participant Flow|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060513|NCT01358864|OG000|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
11060514|NCT01358864|OG001|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
11060515|NCT01358864|OG002|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
11060516|NCT01358864|OG003|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060517|NCT01358864|OG004|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060518|NCT01358864|OG000|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
11060519|NCT01358864|OG001|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
11060520|NCT01358864|OG002|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
11060521|NCT01358864|OG003|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
11060522|NCT01358864|OG004|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060523|NCT01358864|OG005|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060524|NCT01358864|OG006|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060525|NCT01358864|OG007|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060526|NCT01358864|EG000|Reported Event|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
11060527|NCT01358864|EG001|Reported Event|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
11060528|NCT01358864|EG002|Reported Event|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
11060529|NCT01358864|EG003|Reported Event|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060530|NCT01358864|EG004|Reported Event|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
11060531|NCT01358968|BG000|Baseline|All Participants|"Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1. Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.~Participants may have received additional doses of LY2603618 in combination as follows: 1000 milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase OR 500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.~Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11060532|NCT01358968|FG000|Participant Flow|Desipramine (Period 1)|Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
11060533|NCT01358968|FG001|Participant Flow|LY2603618 + Desipramine (Period 2)|Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
11060534|NCT01358968|FG002|Participant Flow|LY2603618 + Gemcitabine (Continued Access)|"1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.~Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11060535|NCT01358968|FG003|Participant Flow|LY2603618 + Pemetrexed (Continued Access)|"500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.~Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11060536|NCT01358968|OG000|Outcome|LY2603618|"Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.~Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2."
11060537|NCT01358968|OG000|Outcome|Desipramine|"Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.~Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2."
11060538|NCT01358968|OG000|Outcome|LY2603618 + Gemcitabine (Continued Access)|"1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.~Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11060539|NCT01358968|OG001|Outcome|LY2603618 + Pemetrexed (Continued Access)|"500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.~Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11060540|NCT01358968|EG000|Reported Event|Desipramine (Period 1)|Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
11060541|NCT01358968|EG001|Reported Event|LY2603618 + Desipramine (Period 2)|Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
11060542|NCT01358968|EG002|Reported Event|LY2603618 + Gemcitabine (Continued Access)|"1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.~Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11060543|NCT01358968|EG003|Reported Event|LY2603618 + Pemetrexed (Continued Access)|"500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.~Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression."
11060544|NCT01358981|BG000|Baseline|Cohort 1: Part A (Healthy): Sequence 1|"Participants received single oral doses of 0.5 milligram (mg), 1.5 mg, 4.5 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: Placebo."
11060545|NCT01358981|BG001|Baseline|Cohort 1: Part A (Healthy): Sequence 2|"Participants received single oral doses of 0.5 mg, 1.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: Placebo, Period 4: 8.4 mg LY2881835."
11060546|NCT01358981|BG002|Baseline|Cohort 1: Part A (Healthy): Sequence 3|"Participants received single oral doses of 0.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 0.5 mg LY2881835, Period 2: Placebo, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835."
11060547|NCT01358981|BG003|Baseline|Cohort 1: Part A (Healthy): Sequence 4|"Participants received single oral doses of 1.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835."
11060548|NCT01358981|BG004|Baseline|Cohort 2: Part B (T2DM): Sequence 1|"Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 8.4 mg LY2881835, Period 2: 8.4 mg LY2881835, Period 3: Placebo."
11060549|NCT01358981|BG005|Baseline|Cohort 2: Part B (T2DM): Sequence 2|"Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 8.4 mg LY2881835, Period 2: Placebo, Period 3: 8.4 mg LY2881835."
11060550|NCT01358981|BG006|Baseline|Cohort 2: Part B (T2DM): Sequence 3|"Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo, Period 2: 8.4 mg LY2881835, Period 3: 8.4 mg LY2881835."
11060551|NCT01358981|BG007|Baseline|Total|Total of all reporting groups
11060552|NCT01358981|FG000|Participant Flow|Cohort 1: Part A (Healthy): Sequence 1|"Participants received single oral doses of 0.5 milligram (mg), 1.5 mg, 4.5 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: Placebo."
11060553|NCT01358981|FG001|Participant Flow|Cohort 1: Part A (Healthy): Sequence 2|"Participants received single oral doses of 0.5 mg, 1.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: Placebo, Period 4: 8.4 mg LY2881835."
11060554|NCT01358981|FG002|Participant Flow|Cohort 1: Part A (Healthy): Sequence 3|"Participants received single oral doses of 0.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 0.5 mg LY2881835, Period 2: Placebo, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835."
11060555|NCT01358981|FG003|Participant Flow|Cohort 1: Part A (Healthy): Sequence 4|"Participants received single oral doses of 1.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835."
11060556|NCT01358981|FG004|Participant Flow|Cohort 2: Part B (T2DM): Sequence 1|"Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 8.4 mg LY2881835, Period 2: 8.4 mg LY2881835, Period 3: Placebo."
11060557|NCT01358981|FG005|Participant Flow|Cohort 2: Part B (T2DM): Sequence 2|"Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: 8.4 mg LY2881835, Period 2: Placebo, Period 3: 8.4 mg LY2881835."
11060558|NCT01358981|FG006|Participant Flow|Cohort 2: Part B (T2DM): Sequence 3|"Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo, Period 2: 8.4 mg LY2881835, Period 3: 8.4 mg LY2881835."
11060559|NCT01358981|OG000|Outcome|Part A - Placebo|Single oral dose of placebo in a study period in Part A (Healthy).
11060560|NCT01358981|OG001|Outcome|Part A - 0.5 mg LY2881835|Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
11060561|NCT01358981|OG002|Outcome|Part A - 1.5 mg LY2881835|Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
11060562|NCT01358981|OG003|Outcome|Part A - 4.5 mg LY2881835|Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
11060563|NCT01358981|OG004|Outcome|Part A - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
11060564|NCT01358981|OG005|Outcome|Part B - Placebo|Single oral dose of placebo in a study period in Part B [Type 2 Diabetes Mellitus (T2DM)].
11060565|NCT01358981|OG006|Outcome|Part B - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
11060566|NCT01358981|OG000|Outcome|Part A - 0.5 mg LY2881835|Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
11060567|NCT01358981|OG001|Outcome|Part A - 1.5 mg LY2881835|Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
11060568|NCT01358981|OG002|Outcome|Part A - 4.5 mg LY2881835|Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
11060569|NCT01358981|OG003|Outcome|Part A - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
11060570|NCT01358981|OG004|Outcome|Part B, Study Period 1 - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in Study Period 1 in Part B [Type 2 Diabetes Mellitus (T2DM)].
11060571|NCT01358981|OG005|Outcome|Part B, Study Period 2 - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in Study Period 2 in Part B (T2DM).
11060572|NCT01358981|OG006|Outcome|Part B, Study Period 3 - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in Study Period 3 in Part B (T2DM).
11060573|NCT01358981|OG007|Outcome|Part B, Study Periods 1, 2, and 3 - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
11060574|NCT01358981|OG001|Outcome|Part A - 0.5 mg LY2881835|Single oral dose of 0.5 mg LY2881835 in a study period in Part A (Healthy).
11060575|NCT01358981|EG000|Reported Event|Part A - Placebo|Single oral dose of placebo in a study period in Part A (Healthy).
11060576|NCT01358981|EG001|Reported Event|Part A - 0.5 mg LY2881835|Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
11060577|NCT01358981|EG002|Reported Event|Part A - 1.5 mg LY2881835|Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
11060578|NCT01358981|EG003|Reported Event|Part A - 4.5 mg LY2881835|Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
11060579|NCT01358981|EG004|Reported Event|Part A - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
11060580|NCT01358981|EG005|Reported Event|Part B - Placebo|Single oral dose of placebo in a study period in Part B [Type 2 Diabetes Mellitus (T2DM)].
11060581|NCT01358981|EG006|Reported Event|Part B - 8.4 mg LY2881835|Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
11060582|NCT01359007|BG000|Baseline|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
11066854|NCT01393990|EG007|Reported Event|Part A: 200 mg LY2228820 Capsules|200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11060583|NCT01359007|FG000|Participant Flow|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
11060584|NCT01359007|OG000|Outcome|5-FU, Leucovorin, Oxaliplatin, Irinotecan|As per above
11060585|NCT01359007|OG000|Outcome|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
11060586|NCT01359007|EG000|Reported Event|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
11060587|NCT01359046|BG000|Baseline|Silver SPC|"Subjects randomized to receive silver-impregnated SPC.~silver SPC: subject randomized to receive silver alloy impregnated catheter"
11060588|NCT01359046|BG001|Baseline|Standard SPC|"subjects randomized to receive standard SPC.~standard SPC: subject randomized to receive standard catheter"
11060589|NCT01359046|BG002|Baseline|Total|Total of all reporting groups
11060590|NCT01359046|FG000|Participant Flow|Silver SPC|"Subjects randomized to receive silver-impregnated SPC.~silver SPC: subject randomized to receive silver alloy impregnated catheter"
11060591|NCT01359046|FG001|Participant Flow|Standard SPC|"subjects randomized to receive standard SPC.~standard SPC: subject randomized to receive standard catheter"
11060592|NCT01359046|OG000|Outcome|Silver SPC|"Subjects randomized to receive silver-impregnated SPC.~silver SPC: subject randomized to receive silver alloy impregnated catheter"
11060593|NCT01359046|OG001|Outcome|Standard SPC|"subjects randomized to receive standard SPC.~standard SPC: subject randomized to receive standard catheter"
10887132|NCT00498940|FG000|Participant Flow|Biventricular Pacing|"After weaning from bypass, patients will receive temporary biventricular pacing for 24 hours. Values obtained from optimization testing will determine pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours."
10887133|NCT00498940|FG001|Participant Flow|Standard of Care|"No post operative pacing is to occur. Patients will undergo optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass."
10887281|NCT00499616|FG002|Participant Flow|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
11060594|NCT01359046|EG000|Reported Event|Silver SPC|"Subjects randomized to receive silver-impregnated SPC.~silver SPC: subject randomized to receive silver alloy impregnated catheter"
11060595|NCT01359046|EG001|Reported Event|Standard SPC|"subjects randomized to receive standard SPC.~standard SPC: subject randomized to receive standard catheter"
11060596|NCT01359111|BG000|Baseline|Intradermal Adapter|Saline injection with intradermal adapter
11060597|NCT01359111|FG000|Participant Flow|Intradermal Adapter|Saline injection with intradermal adapter
11060598|NCT01359111|OG000|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
11060599|NCT01359111|OG000|Outcome|Bevel Up|Saline injection with intradermal adapter used with needle bevel oriented up relative to the surface of the skin
11060600|NCT01359111|OG001|Outcome|Bevel Down|Saline injection with intradermal adapter used with needle bevel oriented down relative to the surface of the skin
11060601|NCT01359111|EG000|Reported Event|Intradermal Adapter|Saline injection with intradermal adapter
11060602|NCT01359150|BG000|Baseline|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
11060603|NCT01359150|BG001|Baseline|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
11060604|NCT01359150|BG002|Baseline|Total|Total of all reporting groups
11149509|NCT01871142|OG001|Outcome|Placebo + Hypoxia|"Number of participants receiving placebo in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
11060605|NCT01359150|FG000|Participant Flow|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
11060606|NCT01359150|FG001|Participant Flow|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
11060607|NCT01359150|OG000|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
11060608|NCT01359150|OG001|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
11060609|NCT01359150|EG000|Reported Event|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
11060610|NCT01359150|EG001|Reported Event|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
11060611|NCT01359371|BG000|Baseline|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital an follow-up volunteer peer telephone counseling
11060612|NCT01359371|FG000|Participant Flow|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
11060613|NCT01359371|OG000|Outcome|Quit Rate With Low Participation in Counseling|Quit rate of those reached 0-1 times for peer telephone counseling.
11060614|NCT01359371|OG001|Outcome|Quit Rate High Participation in Counseling|Quit rate of those reached 2-4 times for peer telephone cessation counseling.
11060615|NCT01359371|OG000|Outcome|High Participation|Reached 2-4 times for telephone counseling
11060616|NCT01359371|OG001|Outcome|Low Participation|Reached 0-1 times for telephone counseling
11060617|NCT01359371|OG000|Outcome|Interviews With Veterans About Satisfaction|25 of the 131 Veteran smoker participants who received the standard-of-care Tobacco Tactics intervention while in the hospital and were interviewed about their satisfaction with the volunteer peer telephone cessation counseling.
11060618|NCT01359371|OG000|Outcome|Costs Per Quit of Peer Cessation Telephone Counseling|The cohort is 131 Veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital and were interviewed about their satisfaction with peer cessation telephone counseling and 4 peer telephone counselors.
11060619|NCT01359371|EG000|Reported Event|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
11060620|NCT01359410|BG000|Baseline|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
11060621|NCT01359410|BG001|Baseline|Stapled Transection Without Mesh Reinforcement|
11060622|NCT01359410|BG002|Baseline|Total|Total of all reporting groups
11060623|NCT01359410|FG000|Participant Flow|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
11060624|NCT01359410|FG001|Participant Flow|Stapled Transection Without Mesh Reinforcement|
11060625|NCT01359410|OG000|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
11060626|NCT01359410|OG001|Outcome|Stapled Transection Without Mesh Reinforcement|
11060627|NCT01359410|EG000|Reported Event|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
11060628|NCT01359410|EG001|Reported Event|Stapled Transection Without Mesh Reinforcement|
11060629|NCT01359449|BG000|Baseline|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
11060630|NCT01359449|BG001|Baseline|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
11060631|NCT01359449|BG002|Baseline|Total|Total of all reporting groups
11060632|NCT01359449|FG000|Participant Flow|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
11060633|NCT01359449|FG001|Participant Flow|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
11060634|NCT01359449|OG000|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
11060635|NCT01359449|OG001|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
11060636|NCT01359449|EG000|Reported Event|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
11060637|NCT01359449|EG001|Reported Event|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
11060638|NCT01359592|BG000|Baseline|R-CHOP x 3|"Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060639|NCT01359592|FG000|Participant Flow|R-CHOP x 3|"Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060640|NCT01359592|FG001|Participant Flow|R-CHOP x 6|"Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060641|NCT01359592|FG002|Participant Flow|PET-negative: R-CHOP x 1|"Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP~R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060642|NCT01359592|FG003|Participant Flow|PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®)|"Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed.~Radiation Therapy included:~IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy~Radioimmunotherapy included:~Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9~Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9"
11060643|NCT01359592|OG000|Outcome|R-CHOP x 3 Followed by PET-directed Therapy|"R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~PET-directed therapy included:~PET-negative: R-CHOP x 1 PET-positive: IFRT + Yttrium-90 ibritumomab tiuxetan~R-CHOP x 1: 1 cycle of R-CHOP, 21 days/cycle~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~IFRT + Yttrium-90 ibritumomab tiuxetan included:~IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy~Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9~Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9"
11060644|NCT01359592|OG000|Outcome|Interim PET-negative|"Interim PET/CT scan was performed on Day 15-18 of Cycle 3 of R-CHOP chemotherapy. PET/CT scans were centrally reviewed and scored.~Negative:~no uptake~uptake ≤ mediastinum~uptake > mediastinum but ≤ liver"
11060645|NCT01359592|OG001|Outcome|Interim PET-positive|"Interim PET/CT scan was performed on Day 15-18 of Cycle 3 of R-CHOP chemotherapy. PET/CT scans were centrally reviewed and scored.~Positive:~4 uptake > liver in some sites even if uptake ≤ liver or mediastinum at other sites 5 uptake > liver in over 90% of sites or development of new uptake consistent with progressive disease"
11060646|NCT01359592|OG000|Outcome|R-CHOP x 3|"Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060647|NCT01359592|OG001|Outcome|R-CHOP x 6|"Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
10887134|NCT00498940|OG000|Outcome|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
11060648|NCT01359592|OG002|Outcome|PET-negative: R-CHOP x 1|"Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP~R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060649|NCT01359592|OG003|Outcome|PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®)|"Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed.~Radiation Therapy included:~IFRT:180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy~Radioimmunotherapy included:~Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9~Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9"
11060650|NCT01359592|OG000|Outcome|R-CHOP x 3 Followed by R-CHOP x 1 in Interim PET-negative Patients|"R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~PET-directed therapy included:~PET-negative: R-CHOP x 1~R-CHOP x 1: 1 cycle of R-CHOP, 21 days/cycle~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060651|NCT01359592|OG001|Outcome|R-CHOP x 3 Followed by IFRT + Yttrium-90 Ibritumomab Tiuxetan in Interim PET-positive Patients|"R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5~PET-directed therapy included:~PET-positive: IFRT + Yttrium-90 ibritumomab tiuxetan~IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy~Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9~Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9"
11060652|NCT01359592|EG000|Reported Event|R-CHOP x 3|"Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060653|NCT01359592|EG001|Reported Event|R-CHOP x 6|"Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP~For each cycle, R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5"
11060654|NCT01359592|EG002|Reported Event|PET-negative: R-CHOP x 1|"Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP~R-CHOP therapy included:~Rituximab: 375 mg/m^2 IV administration on Day 1~Cyclophosphamide: 750 mg/m^2 IV administration on Day 1~Doxorubicin: 50 mg/m^2 IV administration on Day 1~Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1~Prednisone: 100 mg administered orally on Days 1 through 5 2"
11060655|NCT01359592|EG003|Reported Event|PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®)|"Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed.~Radiation Therapy included:~IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy~Radioimmunotherapy included:~Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9~Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9"
11060656|NCT01359644|BG000|Baseline|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotype 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
11060657|NCT01359644|BG001|Baseline|Treatment: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
11060658|NCT01359644|BG002|Baseline|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
11060659|NCT01359644|BG003|Baseline|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype-2 or -3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks..
11060660|NCT01359644|BG004|Baseline|Treatment E: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
11060661|NCT01359644|BG005|Baseline|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
11060662|NCT01359644|BG006|Baseline|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype1 a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks..
11060663|NCT01359644|BG007|Baseline|Treatment H: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
11060664|NCT01359644|BG008|Baseline|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily and daclatasvir, 60 mg, once daily for 24 weeks.
11060665|NCT01359644|BG009|Baseline|Treatment J: Sofosbuvir +Daclatasvir +Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavarin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg) and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
11060666|NCT01359644|BG010|Baseline|Total|Total of all reporting groups
11060667|NCT01359644|FG000|Participant Flow|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
11060668|NCT01359644|FG001|Participant Flow|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
11060669|NCT01359644|FG002|Participant Flow|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
11060670|NCT01359644|FG003|Participant Flow|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
11060671|NCT01359644|FG004|Participant Flow|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
11060672|NCT01359644|FG005|Participant Flow|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
11060673|NCT01359644|FG006|Participant Flow|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
11060674|NCT01359644|FG007|Participant Flow|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
11060675|NCT01359644|FG008|Participant Flow|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
11060676|NCT01359644|FG009|Participant Flow|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
11060677|NCT01359644|OG000|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
11060678|NCT01359644|OG001|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
11060679|NCT01359644|OG002|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
11060680|NCT01359644|OG000|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir 400 mg tablets + daclatasvir 60 mg tablets ± ribavirin (a total daily dose of 1000 mg/1200mg) tablets once daily for 12 or 24 weeks.
11060681|NCT01359644|OG001|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
11060682|NCT01359644|OG002|Outcome|Telaprevir/Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
11060683|NCT01359644|OG002|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
11060684|NCT01359644|OG000|Outcome|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotypes 1a or 1b received sofosbuvir, 400 mg, once daily) for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
11060685|NCT01359644|OG001|Outcome|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
11060686|NCT01359644|OG002|Outcome|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
11060687|NCT01359644|OG003|Outcome|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
11060688|NCT01359644|OG004|Outcome|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
11060689|NCT01359644|OG005|Outcome|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
11060690|NCT01359644|OG006|Outcome|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
11060691|NCT01359644|OG007|Outcome|Treatment H: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
11060692|NCT01359644|OG008|Outcome|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
11060693|NCT01359644|OG009|Outcome|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
11060694|NCT01359644|OG000|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
11060695|NCT01359644|OG001|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
11060696|NCT01359644|OG002|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
11060697|NCT01359644|OG003|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
11060698|NCT01359644|EG000|Reported Event|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
11060699|NCT01359644|EG001|Reported Event|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks
11060700|NCT01359644|EG002|Reported Event|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
11060701|NCT01359644|EG003|Reported Event|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
10887135|NCT00498940|OG001|Outcome|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
11060702|NCT01359644|EG004|Reported Event|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
11060703|NCT01359644|EG005|Reported Event|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks
11060704|NCT01359644|EG006|Reported Event|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
11066855|NCT01393990|EG008|Reported Event|Part A: 160 mg LY2228820 Bridge|In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
11060705|NCT01359644|EG007|Reported Event|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
11060706|NCT01359644|EG008|Reported Event|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
11060707|NCT01359644|EG009|Reported Event|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
11060708|NCT01359735|BG000|Baseline|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
11060709|NCT01359735|BG001|Baseline|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
11060710|NCT01359735|BG002|Baseline|Total|Total of all reporting groups
11060711|NCT01359735|FG000|Participant Flow|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
11060712|NCT01359735|FG001|Participant Flow|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
11060713|NCT01359735|OG000|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
11060714|NCT01359735|OG001|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
11060715|NCT01359735|EG000|Reported Event|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
11060716|NCT01359735|EG001|Reported Event|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
11060717|NCT01359748|BG000|Baseline|Wrist Size <=14.25Cm|Subjects, males or females, with wrist size specified.
11060718|NCT01359748|BG001|Baseline|Wrist Size<=16.40 Cm|Subjects, males or females, with wrist size specified.
11060719|NCT01359748|BG002|Baseline|Wrist Size >=16.5 Cm|Subjects, males or females, with wrist size specified.
11060720|NCT01359748|BG003|Baseline|Wrist Size >=17.75|Subjects, males or females, with wrist size specified.
11060721|NCT01359748|BG004|Baseline|Total|Total of all reporting groups
11060722|NCT01359748|FG000|Participant Flow|Subjects With Wrist Size >=14.26Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
11060723|NCT01359748|FG001|Participant Flow|Subjects With Wrist Size <=14.25Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
11060724|NCT01359748|FG002|Participant Flow|Subjects With Wrist Size >=16.50Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
11060725|NCT01359748|FG003|Participant Flow|Subjects With Wrist Size >=17.75Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
11060726|NCT01359748|OG000|Outcome|Subjects|Subjects who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
11060727|NCT01359748|OG000|Outcome|Subjects|Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
11060728|NCT01359748|EG000|Reported Event|Wrist Size <=14.25 Cm|Subjects with wrist size equal or less than 14.25 Cm
11060729|NCT01359748|EG001|Reported Event|Wrist Size <=16.4Cm|Subjects with wrist size equal or less than 16.40 Cm
11060730|NCT01359748|EG002|Reported Event|Wrist Size >=16.5 Cm|Subjects with wrist size equal or higher than 16.5 Cm
11060731|NCT01359748|EG003|Reported Event|Wrist Size >=17.75 Cm|Subjects with wrist size equal or higher than 17.75 Cm
11060732|NCT01359904|BG000|Baseline|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
11060733|NCT01359904|BG001|Baseline|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
11060734|NCT01359904|BG002|Baseline|Total|Total of all reporting groups
11060735|NCT01359904|FG000|Participant Flow|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
11060736|NCT01359904|FG001|Participant Flow|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
11060737|NCT01359904|OG000|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
11060738|NCT01359904|OG001|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
11060739|NCT01359904|EG000|Reported Event|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
11060740|NCT01359904|EG001|Reported Event|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
11060741|NCT01359943|BG000|Baseline|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
11060742|NCT01359943|BG001|Baseline|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
11060743|NCT01359943|BG002|Baseline|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
11060744|NCT01359943|BG003|Baseline|Total|Total of all reporting groups
11060745|NCT01359943|FG000|Participant Flow|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
11060746|NCT01359943|FG001|Participant Flow|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
11060747|NCT01359943|FG002|Participant Flow|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
11060748|NCT01359943|OG000|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
11060749|NCT01359943|OG001|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
11060750|NCT01359943|OG002|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
11060751|NCT01359943|EG000|Reported Event|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
11060752|NCT01359943|EG001|Reported Event|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
11060753|NCT01359943|EG002|Reported Event|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
11060754|NCT01359943|EG003|Reported Event|AIN457 Pooled Treatment Groups - Open Label Period|Week 16 through week 52: AIN457 150 mg s.c. open label
11060755|NCT01359943|EG004|Reported Event|AIN457 Pooled Treatment Groups - Follow-up Period|Follow-up period: week 52 through week 60 - AIN457 150 mg sc open label
11060756|NCT01359956|BG000|Baseline|A1 - Combination Chemotherapy Without Interferon|"combination chemotherapy without interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle"
11060757|NCT01359956|BG001|Baseline|A2 - Combination Chemotherapy With Interferon|"combination chemotherapy with interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle~Interferon Alfa-2b: α2b 5 MUI three times per week"
11060758|NCT01359956|BG002|Baseline|B1 - Single Agent Dacarbazine Without Interferon|"single agent dacarbazine without interferon~Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle"
11060759|NCT01359956|BG003|Baseline|B2 - Single Agent Dacarbazine Plus Interferon|"single agent dacarbazine plus interferon~Dacarbazine: 900 mg / m2 every 3 weeks~Interferon Alfa-2b: α2b 5 MUI three times per week"
11060760|NCT01359956|BG004|Baseline|Total|Total of all reporting groups
11060761|NCT01359956|FG000|Participant Flow|A1 - Combination Chemotherapy Without Interferon|"combination chemotherapy without interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle"
11060762|NCT01359956|FG001|Participant Flow|A2 - Combination Chemotherapy With Interferon|"combination chemotherapy with interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle~Interferon Alfa-2b: α2b 5 MUI three times per week"
11060763|NCT01359956|FG002|Participant Flow|B1 - Single Agent Dacarbazine Without Interferon|"single agent dacarbazine without interferon~Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle"
11060764|NCT01359956|FG003|Participant Flow|B2 - Single Agent Dacarbazine Plus Interferon|"single agent dacarbazine plus interferon~Dacarbazine: 900 mg / m2 every 3 weeks~Interferon Alfa-2b: α2b 5 MUI three times per week"
11060765|NCT01359956|OG000|Outcome|Fotemustine/Dacarbazine/Interferon + Fotemustine/Dacarbazine|"combination chemotherapy with interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle~Interferon Alfa-2b: α2b 5 MUI three times per week~combination chemotherapy without interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle"
11060766|NCT01359956|OG001|Outcome|Dacarbazine/Interferon + Dacarbazine|"single agent dacarbazine plus interferon~Dacarbazine: 900 mg / m2 every 3 weeks~Interferon Alfa-2b: α2b 5 MUI three times per week~single agent dacarbazine without interferon~Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle"
11060767|NCT01359956|OG002|Outcome|Fotemustine/Dacarbazine/Interferon+Dacarbazine/Interferon|"combination chemotherapy with interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle~Interferon Alfa-2b: α2b 5 MUI three times per week~single agent dacarbazine plus interferon~Dacarbazine: 900 mg / m2 every 3 weeks~Interferon Alfa-2b: α2b 5 MUI three times per week"
11060768|NCT01359956|OG003|Outcome|Fotemustine/Dacarbazine + Dacarbazine|"combination chemotherapy without interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle~single agent dacarbazine without interferon~Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle"
11060769|NCT01359956|EG000|Reported Event|A1 - Combination Chemotherapy Without Interferon|"combination chemotherapy without interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle"
11060770|NCT01359956|EG001|Reported Event|A2 - Combination Chemotherapy With Interferon|"combination chemotherapy with interferon~Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle~Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle~Interferon Alfa-2b: α2b 5 MUI three times per week"
11060771|NCT01359956|EG002|Reported Event|B1 - Single Agent Dacarbazine Without Interferon|"single agent dacarbazine without interferon~Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle"
11060772|NCT01359956|EG003|Reported Event|B2 - Single Agent Dacarbazine Plus Interferon|"single agent dacarbazine plus interferon~Dacarbazine: 900 mg / m2 every 3 weeks~Interferon Alfa-2b: α2b 5 MUI three times per week"
11060773|NCT01360021|BG000|Baseline|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
11060774|NCT01360021|BG001|Baseline|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
11060775|NCT01360021|BG002|Baseline|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
11060776|NCT01360021|BG003|Baseline|Total|Total of all reporting groups
11060777|NCT01360021|FG000|Participant Flow|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
11060778|NCT01360021|FG001|Participant Flow|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
11060779|NCT01360021|FG002|Participant Flow|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
11060780|NCT01360021|OG000|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
11060781|NCT01360021|OG001|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
11060782|NCT01360021|OG002|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
11060783|NCT01360021|EG000|Reported Event|Budesonide|
11060784|NCT01360021|EG001|Reported Event|Symbicort BA MDI|
11060785|NCT01360021|EG002|Reported Event|Symbicort pMDI|
11060786|NCT01360229|BG000|Baseline|Randomized Subjects Receive a Sham Acupuncture.|"Subjects were randomized in a 1:1 ratio to receive either real or sham acupuncture.~Acupuncture to treat fatigue in Parkinson disease: Subjects will be randomized in a 1:1 ratio to receive sham acupuncture."
11060787|NCT01360229|BG001|Baseline|Randomized Subjects Receive Real Acupuncture.|"Subjects were randomized in a 1:1 ratio to receive either real or sham acupuncture.~Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture.~Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes"
11060788|NCT01360229|BG002|Baseline|Total|Total of all reporting groups
11060789|NCT01360229|FG000|Participant Flow|Randomized Subjects Receive a Sham Acupuncture.|"Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.~Acupuncture to treat fatigue in Parkinson disease: Subjects will be randomized in a 1:1 ratio to receive sham acupuncture."
11060790|NCT01360229|FG001|Participant Flow|Randomized Subjects Receive Real Acupuncture.|"Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.~Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture.~Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes"
11060791|NCT01360229|OG000|Outcome|Randomized Subjects Receive a Sham Acupuncture.|"Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.~Acupuncture to treat fatigue in Parkinson disease: Subjects will be randomized in a 1:1 ratio to receive sham acupuncture."
11060792|NCT01360229|OG001|Outcome|Randomized Subjects Receive Real Acupuncture.|"Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.~Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture.~Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes"
11060793|NCT01360229|EG000|Reported Event|Randomized Subjects Receive a Sham Acupuncture.|"Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.~Acupuncture to treat fatigue in Parkinson disease: Subjects will be randomized in a 1:1 ratio to receive sham acupuncture."
11060794|NCT01360229|EG001|Reported Event|Randomized Subjects Receive Real Acupuncture.|"Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.~Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture.~Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes"
11060795|NCT01360398|BG000|Baseline|Total Group|Chronic Obstructive Pulmonary Disease [COPD] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
11060796|NCT01360398|FG000|Participant Flow|Total Group|Chronic Obstructive Pulmonary Disease [COPD] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
11060797|NCT01360398|OG000|Outcome|Total Group|Chronic Obstructive Pulmonary Disease [COPD] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
11060798|NCT01360398|EG000|Reported Event|Total Group|Chronic Obstructive Pulmonary Disease [COPD] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
11060799|NCT01360450|BG000|Baseline|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
11060800|NCT01360450|BG001|Baseline|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
11060801|NCT01360450|BG002|Baseline|Total|Total of all reporting groups
11060802|NCT01360450|FG000|Participant Flow|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine Hydrochloride: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
11060803|NCT01360450|FG001|Participant Flow|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
11060804|NCT01360450|OG000|Outcome|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
11060805|NCT01360450|OG001|Outcome|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
11060806|NCT01360450|OG000|Outcome|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine Hydrochloride: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
11060807|NCT01360450|EG000|Reported Event|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
11060808|NCT01360450|EG001|Reported Event|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
11060809|NCT01360554|BG000|Baseline|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
11060810|NCT01360554|BG001|Baseline|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
11060811|NCT01360554|BG002|Baseline|Total|Total of all reporting groups
11060812|NCT01360554|FG000|Participant Flow|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
11060813|NCT01360554|FG001|Participant Flow|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
11060814|NCT01360554|OG000|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
11060815|NCT01360554|OG001|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
11060816|NCT01360554|EG000|Reported Event|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
11060817|NCT01360554|EG001|Reported Event|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
11060818|NCT01360632|BG000|Baseline|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
11060819|NCT01360632|BG001|Baseline|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
11060820|NCT01360632|BG002|Baseline|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
11060821|NCT01360632|BG003|Baseline|Total|Total of all reporting groups
11060822|NCT01360632|FG000|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks.
11060823|NCT01360632|FG001|Participant Flow|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole of [1mg (milligram)] as an adjunctive therapy to an assigned open-label ADT (anti-depressant therapy).
11060824|NCT01360632|FG002|Participant Flow|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
11060825|NCT01360632|FG003|Participant Flow|Double-blind Placebo + ADT|In phase B, participants were administered placebo as an adjunctive therapy to an open label ADT for 6 weeks.
11060826|NCT01360632|FG004|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
11060827|NCT01360632|OG000|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
11060828|NCT01360632|OG001|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
11060829|NCT01360632|OG002|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
11060830|NCT01360632|EG000|Reported Event|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
11060831|NCT01360632|EG001|Reported Event|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
11060832|NCT01360632|EG002|Reported Event|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
11060833|NCT01360645|BG000|Baseline|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
11060834|NCT01360645|BG001|Baseline|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
11060835|NCT01360645|BG002|Baseline|Total|Total of all reporting groups
11060836|NCT01360645|FG000|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks
11060837|NCT01360645|FG001|Participant Flow|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
11060838|NCT01360645|FG002|Participant Flow|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
11060839|NCT01360645|FG003|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
11060840|NCT01360645|OG000|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
11060841|NCT01360645|OG001|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
11060842|NCT01360645|EG000|Reported Event|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
11060843|NCT01360645|EG001|Reported Event|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
11060844|NCT01360762|BG000|Baseline|Pentamidine Secondary Prophylaxis (PSP)|Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
11060845|NCT01360762|FG000|Participant Flow|Pentamidine Secondary Prophylaxis (PSP)|Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
11060846|NCT01360762|OG000|Outcome|Pentamidine Secondary Prophylaxis (PSP)|Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
11060847|NCT01360762|EG000|Reported Event|Pentamidine Secondary Prophylaxis (PSP)|Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
11060848|NCT01360840|BG000|Baseline|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060849|NCT01360840|BG001|Baseline|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060850|NCT01360840|BG002|Baseline|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060851|NCT01360840|BG003|Baseline|Total|Total of all reporting groups
11060852|NCT01360840|FG000|Participant Flow|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the standard of care (SoC) consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060853|NCT01360840|FG001|Participant Flow|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060854|NCT01360840|FG002|Participant Flow|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060855|NCT01360840|OG000|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060856|NCT01360840|OG001|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060857|NCT01360840|OG002|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060858|NCT01360840|OG000|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060859|NCT01360840|OG001|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060860|NCT01360840|EG000|Reported Event|Placebo + SoC|Subjects were administered with placebo 0.9 percent (%) sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060861|NCT01360840|EG001|Reported Event|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 milligram (mg) (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11066856|NCT01393990|EG009|Reported Event|Part A: 160 mg LY2228820 Tablets|160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11060862|NCT01360840|EG002|Reported Event|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
11060863|NCT01360866|BG000|Baseline|Prior Placebo|Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060864|NCT01360866|BG001|Baseline|Prior Brexpiprazole|Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060865|NCT01360866|BG002|Baseline|Prior ADT|Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060866|NCT01360866|BG003|Baseline|Prior Seroquel|Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060867|NCT01360866|BG004|Baseline|Total|Total of all reporting groups
11060868|NCT01360866|FG000|Participant Flow|Prior Placebo|Participants who received placebo with antidepressant therapy [ADT] in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060869|NCT01360866|FG001|Participant Flow|Prior Brexpiprazole|Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060870|NCT01360866|FG002|Participant Flow|Prior ADT|Participants who received only ADT in previous double blind phase 3 studies and were not randomized, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060871|NCT01360866|FG003|Participant Flow|Prior Seroquel|Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060872|NCT01360866|OG000|Outcome|Prior Placebo|Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060873|NCT01360866|OG001|Outcome|Prior Brexpiprazole|Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060874|NCT01360866|OG002|Outcome|Prior ADT|Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060875|NCT01360866|OG003|Outcome|Prior Seroquel|Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060876|NCT01360866|EG000|Reported Event|Prior Placebo|Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060877|NCT01360866|EG001|Reported Event|Prior Brexpiprazole|Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060878|NCT01360866|EG002|Reported Event|Prior ADT|Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060879|NCT01360866|EG003|Reported Event|Prior Seroquel|Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
11060880|NCT01360996|BG000|Baseline|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060881|NCT01360996|BG001|Baseline|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060882|NCT01360996|BG002|Baseline|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060883|NCT01360996|BG003|Baseline|Total|Total of all reporting groups
11060884|NCT01360996|FG000|Participant Flow|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060885|NCT01360996|FG001|Participant Flow|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060886|NCT01360996|FG002|Participant Flow|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060887|NCT01360996|OG000|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
11060888|NCT01360996|OG001|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
11060889|NCT01360996|EG000|Reported Event|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060890|NCT01360996|EG001|Reported Event|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060891|NCT01360996|EG002|Reported Event|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
11060892|NCT01361009|BG000|Baseline|Pramipexole Goup|
10887136|NCT00498940|EG000|Reported Event|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
11060893|NCT01361009|FG000|Participant Flow|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
11060894|NCT01361009|OG000|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
11060895|NCT01361009|EG000|Reported Event|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
11060896|NCT01361048|BG000|Baseline|Oral Metronidazole|control arm
11060897|NCT01361048|BG001|Baseline|Neo Penotran Forte Twice a Day|neo penotran forte vaginal suppository twice a day for 7 days
11060898|NCT01361048|BG002|Baseline|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
11060899|NCT01361048|BG003|Baseline|Total|Total of all reporting groups
11060900|NCT01361048|FG000|Participant Flow|Oral Metronidazole|control arm
11060901|NCT01361048|FG001|Participant Flow|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
11060902|NCT01361048|FG002|Participant Flow|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
11060903|NCT01361048|OG000|Outcome|Oral Metronidazole 2 gm Stat Dose|control arm
11060904|NCT01361048|OG001|Outcome|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
11060905|NCT01361048|OG002|Outcome|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
11060906|NCT01361048|OG000|Outcome|Oral Metronidazole|"control arm~oral metronidazole: 2 gm oral once"
11060907|NCT01361048|OG001|Outcome|Neo Penotran Forte|"neo penotran forte vaginal suppository twice a day for 7 days~neo penotran forte: neo penotran forte intravaginal twice a day for 7 days"
11060908|NCT01361048|OG002|Outcome|Neo Penotran Forte Once a Day|"neo penotran forte vaginal suppository once a day for 7 days~neo penotran forte once a day: neo penotran forte intravaginally once a day for 7 days"
11060909|NCT01361048|EG000|Reported Event|Oral Metronidazole|control arm
11060910|NCT01361048|EG001|Reported Event|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
11060911|NCT01361048|EG002|Reported Event|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
11060912|NCT01361113|BG000|Baseline|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
11060913|NCT01361113|FG000|Participant Flow|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
11060914|NCT01361113|OG000|Outcome|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
11060915|NCT01361113|OG000|Outcome|1 Year Recurrence Free Survival|"Single Arm Neoadjuvant Pazopanib~Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
11060916|NCT01361113|OG001|Outcome|2 Year Recurrence Free Survival|"Single Arm Neoadjuvant Pazopanib~Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
11060917|NCT01361113|EG000|Reported Event|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
11060918|NCT01361126|BG000|Baseline|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
11060919|NCT01361126|BG001|Baseline|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
11060920|NCT01361126|BG002|Baseline|Total|Total of all reporting groups
11060921|NCT01361126|FG000|Participant Flow|Prophylactic|For the PK evaluation, subjects received a single intravenous (IV) infusion of Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
11060922|NCT01361126|FG001|Participant Flow|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
11060923|NCT01361126|OG000|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
11060924|NCT01361126|OG000|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
11060925|NCT01361126|OG001|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
11060926|NCT01361126|OG000|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
11060927|NCT01361126|EG000|Reported Event|All Subjects|Subjects received rIX-FP administered by IV infusion as prophylactic treatment once a week or on demand to treat bleeding episodes for 20 weeks.
11060928|NCT01361178|BG000|Baseline|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
10887137|NCT00498940|EG001|Reported Event|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
10887138|NCT00499031|BG000|Baseline|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
11060929|NCT01361178|BG001|Baseline|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
11060930|NCT01361178|BG002|Baseline|Total|Total of all reporting groups
11060931|NCT01361178|FG000|Participant Flow|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
11060932|NCT01361178|FG001|Participant Flow|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
11060933|NCT01361178|OG000|Outcome|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
11060934|NCT01361178|OG001|Outcome|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
11060935|NCT01361178|EG000|Reported Event|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
11060936|NCT01361178|EG001|Reported Event|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
11060937|NCT01361217|BG000|Baseline|Fluoxetine DDI|"Only arm in the study. Successive Control (Study Days 1 and 3) and fluoxetine multiple-dose treatment (Study Days 16 and 18) Sessions.~Fluoxetine: 1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18."
11060938|NCT01361217|FG000|Participant Flow|Fluoxetine DDI|"Only arm in the study. Successive Control (Study Days 1 and 3) and fluoxetine multiple-dose treatment (Study Days 16 and 18) Sessions.~Fluoxetine: 1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18."
11060939|NCT01361217|OG000|Outcome|Lovastatin AUC After Fluoxetine Dosing|"Only arm in the study. Successive Control (Study Days 1 and 3) and fluoxetine multiple-dose treatment (Study Days 16 and 18) Sessions.~Fluoxetine: 1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18."
11060940|NCT01361217|OG001|Outcome|Lovastatin Before Fluoxetine|control
11060941|NCT01361217|OG000|Outcome|Midazolam, Caffeine, Omeprazole, Caffeine AUC After Fluoxetine|"Only arm in the study. Successive Control (Study Days 1 and 3) and fluoxetine multiple-dose treatment (Study Days 16 and 18) Sessions.~Fluoxetine: 1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18."
11060942|NCT01361217|EG000|Reported Event|Fluoxetine DDI|"Only arm in the study. Successive Control (Study Days 1 and 3) and fluoxetine multiple-dose treatment (Study Days 16 and 18) Sessions.~Fluoxetine: 1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18."
11060943|NCT01361308|BG000|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
11060944|NCT01361308|BG001|Baseline|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
11060945|NCT01361308|BG002|Baseline|Total|Total of all reporting groups
11060946|NCT01361308|FG000|Participant Flow|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
11060947|NCT01361308|FG001|Participant Flow|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
11060948|NCT01361308|OG000|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
11060949|NCT01361308|OG001|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
11060950|NCT01361308|EG000|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
11060951|NCT01361308|EG001|Reported Event|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
11060952|NCT01361464|BG000|Baseline|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
11060953|NCT01361464|FG000|Participant Flow|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
11060954|NCT01361464|OG000|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
11060955|NCT01361464|EG000|Reported Event|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
11060956|NCT01361568|BG000|Baseline|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
11060957|NCT01361568|BG001|Baseline|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
11060958|NCT01361568|BG002|Baseline|CR845-CR845|CR845 administered both preoperatively and postoperatively
11060959|NCT01361568|BG003|Baseline|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
11060960|NCT01361568|BG004|Baseline|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
11060961|NCT01361568|BG005|Baseline|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
11060962|NCT01361568|BG006|Baseline|Total|Total of all reporting groups
11060963|NCT01361568|FG000|Participant Flow|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
11060964|NCT01361568|FG001|Participant Flow|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
11060965|NCT01361568|FG002|Participant Flow|CR845-CR845|CR845 administered both preoperatively and postoperatively
11060966|NCT01361568|FG003|Participant Flow|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
11060967|NCT01361568|FG004|Participant Flow|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
11060968|NCT01361568|FG005|Participant Flow|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
11060969|NCT01361568|OG000|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
11060970|NCT01361568|OG001|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
11060971|NCT01361568|OG002|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
11060972|NCT01361568|OG003|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
11060973|NCT01361568|OG000|Outcome|Placebo|Patients administered placebo only either preoperatively and/or postoperatively
11060974|NCT01361568|OG001|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
11060975|NCT01361568|OG000|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
11060976|NCT01361568|EG000|Reported Event|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
11060977|NCT01361568|EG001|Reported Event|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
11060978|NCT01361568|EG002|Reported Event|CR845-CR845|CR845 administered both preoperatively and postoperatively
11060979|NCT01361568|EG003|Reported Event|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
11060980|NCT01361568|EG004|Reported Event|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
11060981|NCT01361568|EG005|Reported Event|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
11060982|NCT01361594|BG000|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
11060983|NCT01361594|BG001|Baseline|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
11060984|NCT01361594|BG002|Baseline|Total|Total of all reporting groups
11060985|NCT01361594|FG000|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
11060986|NCT01361594|FG001|Participant Flow|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
11060987|NCT01361594|OG000|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
11060988|NCT01361594|OG001|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
11060989|NCT01361594|EG000|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
11060990|NCT01361594|EG001|Reported Event|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
11060991|NCT01361607|BG000|Baseline|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11060992|NCT01361607|BG001|Baseline|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
11060993|NCT01361607|BG002|Baseline|Total|Total of all reporting groups
11060994|NCT01361607|FG000|Participant Flow|Nabiximols|Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11060995|NCT01361607|FG001|Participant Flow|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
11060996|NCT01361607|OG000|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11060997|NCT01361607|OG001|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
11060998|NCT01361607|OG000|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray, up to a maximum of 10 sprays per day in the morning and evening, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11060999|NCT01361607|EG000|Reported Event|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11061000|NCT01361607|EG001|Reported Event|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
11061001|NCT01361620|BG000|Baseline|Aspirin|All subjects took 7-10 days of 81 mg aspirin
11061002|NCT01361620|FG000|Participant Flow|Aspirin|All subjects took 7-10 days of 81 mg aspirin
11061003|NCT01361620|OG000|Outcome|Aspirin|All subjects took 7-10 days of 81 mg aspirin
11061004|NCT01361620|EG000|Reported Event|Aspirin|All subjects took 7-10 days of 81 mg aspirin
11061005|NCT01361633|BG000|Baseline|Medication|250 mg d-cycloserine
11061006|NCT01361633|BG001|Baseline|Sugar Pill|Placebo Control
11061007|NCT01361633|BG002|Baseline|Total|Total of all reporting groups
11061008|NCT01361633|FG000|Participant Flow|Medication|250 mg d-cycloserine
11061009|NCT01361633|FG001|Participant Flow|Sugar Pill|Placebo Control
11061010|NCT01361633|OG000|Outcome|Medication|250mg d-cycloserine
11061011|NCT01361633|OG001|Outcome|Sugar Pill|Placebo control
11061012|NCT01361633|OG000|Outcome|Medication|250 mg d-cycloserine
11061013|NCT01361633|OG001|Outcome|Sugar Pill|Placebo Control
11061014|NCT01361633|EG000|Reported Event|Medication|250 mg d-cycloserine
11061015|NCT01361633|EG001|Reported Event|Sugar Pill|Placebo Control
11061016|NCT01361711|BG000|Baseline|Alemtuzumab + Ofatumumab|"Alemtuzumab: Administered subcutaneously, 3 times per week for up to 18 weeks at a standard dose of 30mg (except for week 1 which will dose escalate from 3mg→10mg→30mg).~Ofatumumab: Starting at week 3, administered intravenously on day 1 of every other week prior to alemtuzumab for a total of 8 doses. For week 3 (dose 1) ofatumumab will be given at a dose of 300mg; for weeks 5, 7, 9, 11, 13, 15, and 17 (doses 2-8) ofatumumab will be given at a dose of 2000mg.~Toxicity was assessed after completion of the extended safety run-in period of the first 12 patients at an ofatumumab dose of 2000 mg for doses 2-8. Depending on the number of patients who experienced a dose limiting toxicity in the initial 2 safety cohorts, ofatumumab doses 2-8 could have been continued at 2000 mg or reduced to 1000 mg for subsequent patients. Based on the toxicity data of the first 12 patients, ofatumumab doses 2-8 were given at 2000 mg for doses 2-8 for all patients.~biopsy: Correlative studies"
11061017|NCT01361711|FG000|Participant Flow|Alemtuzumab + Ofatumumab|"Alemtuzumab: Administered subcutaneously, 3 times per week for up to 18 weeks at a standard dose of 30mg (except for week 1 which will dose escalate from 3mg→10mg→30mg).~Ofatumumab: Starting at week 3, administered intravenously on day 1 of every other week prior to alemtuzumab for a total of 8 doses. For week 3 (dose 1) ofatumumab will be given at a dose of 300mg; for weeks 5, 7, 9, 11, 13, 15, and 17 (doses 2-8) ofatumumab will be given at a dose of 2000mg.~Toxicity was assessed after completion of the extended safety run-in period of the first 12 patients at an ofatumumab dose of 2000 mg for doses 2-8. Depending on the number of patients who experienced a dose limiting toxicity in the initial 2 safety cohorts, ofatumumab doses 2-8 could have been continued at 2000 mg or reduced to 1000 mg for subsequent patients. Based on the toxicity data of the first 12 patients, ofatumumab doses 2-8 were given at 2000 mg for doses 2-8 for all patients.~Based on experience with the initial safety run-in cohort of 6 patients, early stopping is necessary to avoid over-treatment in patients who have achieved a complete remission early. As soon as a patient is determined to have achieved MRD- CR or CRi (per iwCLL2008 criteria), both alemtuzumab and ofatumumab will be stopped."
11061018|NCT01361711|OG000|Outcome|Alemtuzumab + Ofatumumab|"Alemtuzumab: Administered subcutaneously, 3 times per week for up to 18 weeks at a standard dose of 30mg (except for week 1 which will dose escalate from 3mg→10mg→30mg).~Ofatumumab: Starting at week 3, administered intravenously on day 1 of every other week prior to alemtuzumab for a total of 8 doses. For week 3 (dose 1) ofatumumab will be given at a dose of 300mg; for weeks 5, 7, 9, 11, 13, 15, and 17 (doses 2-8) ofatumumab will be given at a dose of 2000mg.~Toxicity was assessed after completion of the extended safety run-in period of the first 12 patients at an ofatumumab dose of 2000 mg for doses 2-8. Depending on the number of patients who experienced a dose limiting toxicity in the initial 2 safety cohorts, ofatumumab doses 2-8 could have been continued at 2000 mg or reduced to 1000 mg for subsequent patients. Based on the toxicity data of the first 12 patients, ofatumumab doses 2-8 were given at 2000 mg for doses 2-8 for all patients.~biopsy: Correlative studies"
11061019|NCT01361711|EG000|Reported Event|Alemtuzumab + Ofatumumab|"Alemtuzumab: Administered subcutaneously, 3 times per week for up to 18 weeks at a standard dose of 30mg (except for week 1 which will dose escalate from 3mg→10mg→30mg).~Ofatumumab: Starting at week 3, administered intravenously on day 1 of every other week prior to alemtuzumab for a total of 8 doses. For week 3 (dose 1) ofatumumab will be given at a dose of 300mg; for weeks 5, 7, 9, 11, 13, 15, and 17 (doses 2-8) ofatumumab will be given at a dose of 2000mg.~Toxicity was assessed after completion of the extended safety run-in period of the first 12 patients at an ofatumumab dose of 2000 mg for doses 2-8. Depending on the number of patients who experienced a dose limiting toxicity in the initial 2 safety cohorts, ofatumumab doses 2-8 could have been continued at 2000 mg or reduced to 1000 mg for subsequent patients. Based on the toxicity data of the first 12 patients, ofatumumab doses 2-8 were given at 2000 mg for doses 2-8 for all patients.~Based on experience with the initial safety run-in cohort of 6 patients, early stopping is necessary to avoid over-treatment in patients who have achieved a complete remission early. As soon as a patient is determined to have achieved MRD- CR or CRi (per iwCLL2008 criteria), both alemtuzumab and ofatumumab will be stopped."
11061020|NCT01361854|BG000|Baseline|Polysomnography for Suspicion of SDB|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital"
11061021|NCT01361854|FG000|Participant Flow|Home Hook-up First Then Hook-up in the Hospital|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at home first.~Croosover design. 2nd polysomnography with in-lab hook-up performed within 2 weeks"
11061022|NCT01361854|FG001|Participant Flow|Hospital Hook-up First, Then Home Hook-up|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at the hospital Croosover design. 2nd polysomnography with home hook-up performed within 2 weeks"
11061023|NCT01361854|OG000|Outcome|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with home hook-up first"
11061024|NCT01361854|OG001|Outcome|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography:home polysomnography with in-lab hook up first"
11061025|NCT01361854|EG000|Reported Event|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at home"
11061026|NCT01361854|EG001|Reported Event|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed in the sleep lab"
11061027|NCT01361867|BG000|Baseline|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
11061028|NCT01361867|FG000|Participant Flow|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
11061029|NCT01361867|OG000|Outcome|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
11061030|NCT01361867|EG000|Reported Event|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
11061031|NCT01361919|BG000|Baseline|Feedback During CPR Training and Testing|"A feedback defibrillator (ZOLL R series) will be used at teaching, immediate testing and 12 week (retention) testing. A simulation manikin with an attached accelerometer pad on its sternum will be used to collect CPR performance data. Subjects will be told to perform compressions on top of the accelerometer pad and will be taught to use and follow the audio and visual feedback to optimize their CPR performance. After training, the raw data collected by the accelerometer will be used as a demonstration and training tool, to correct the subjects' performance by visually demonstrating the difference between ideal and suboptimal CPR performance. Testing will be carried out with the use of a feedback defibrillator."
11061032|NCT01361919|BG001|Baseline|Feedback During CPR Training Not Testing|"A feedback defibrillator will be used for teaching, with a standard no feedback defibrillator used at immediate and 12 week (retention) testing to assess if the techniques the students' learned during training are transferable to devices without feedback. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. Participants will be taught to use and follow the audio and visual feedback provided by the accelerometer and defibrillator to optimize their CPR perfor"
11061033|NCT01361919|BG002|Baseline|No Feedback Group|"A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur.~No Feedback during CPR Testing or Training: A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest."
11061034|NCT01361919|BG003|Baseline|Total|Total of all reporting groups
11061035|NCT01361919|FG000|Participant Flow|Feedback During CPR Training and Testing|"A feedback defibrillator (ZOLL R series) will be used at teaching, immediate testing and 12 week (retention) testing. A simulation manikin with an attached accelerometer pad on its sternum will be used to collect CPR performance data. Subjects will be told to perform compressions on top of the accelerometer pad and will be taught to use and follow the audio and visual feedback to optimize their CPR performance. After training, the raw data collected by the accelerometer will be used as a demonstration and training tool, to correct the subjects' performance by visually demonstrating the difference between ideal and suboptimal CPR performance. Testing will be carried out with the use of a feedback defibrillator.~Feedback during CPR training: Students in this group will receive training in BLS skills according to the 2005 AHA/ILCOR guidelines, using the ZOLL R Series™ defibrillator with an attached accelerometer pad that will be placed on the sternum of the manikin and visible to"
11061036|NCT01361919|FG001|Participant Flow|Feedback During CPR Training Not Testing|"A feedback defibrillator will be used for teaching, with a standard no feedback defibrillator used at immediate and 12 week (retention) testing to assess if the techniques the students' learned during training are transferable to devices without feedback. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest.~Feedback during CPR training: Students in this group will receive training in BLS skills according to the 2005 AHA/ILCOR guidelines, using the ZOLL R Series™ defibrillator with an attached accelerometer pad that will be placed on the manikin's sternum and is visible to the user. Students will be told to perform compressions on top of the accelerometer pad. Participants will be taught to use and follow the audio and visual feedback provided by the accelerometer and defibrillator to optimize their CPR perf"
11061037|NCT01361919|FG002|Participant Flow|No Feedback Group|"A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur.~No Feedback during CPR Testing or Training: A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded."
11061038|NCT01361919|OG000|Outcome|Feedback During CPR Training and Testing|"A feedback defibrillator (ZOLL R series) will be used at teaching, immediate testing and 12 week (retention) testing. A simulation manikin with an attached accelerometer pad on its sternum will be used to collect CPR performance data. Subjects will be told to perform compressions on top of the accelerometer pad and will be taught to use and follow the audio and visual feedback to optimize their CPR performance. After training, the raw data collected by the accelerometer will be used as a demonstration and training tool, to correct the subjects' performance by visually demonstrating the difference between ideal and suboptimal CPR performance. Testing will be carried out with the use of a feedback defibrillator."
11061039|NCT01361919|OG001|Outcome|Feedback During CPR Training Not Testing|"A feedback defibrillator will be used for teaching, with a standard no feedback defibrillator used at immediate and 12 week (retention) testing to assess if the techniques the students' learned during training are transferable to devices without feedback. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. Participants will be taught to use and follow the audio and visual feedback provided by the accelerometer and defibrillator to optimize their CPR perfor"
10887139|NCT00499031|FG000|Participant Flow|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
11061040|NCT01361919|OG002|Outcome|No Feedback Group|"A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur.~No Feedback during CPR Testing or Training: A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest."
11061041|NCT01361919|EG000|Reported Event|Feedback During CPR Training and Testing|"A feedback defibrillator (ZOLL R series) will be used at teaching, immediate testing and 12 week (retention) testing. A simulation manikin with an attached accelerometer pad on its sternum will be used to collect CPR performance data. Subjects will be told to perform compressions on top of the accelerometer pad and will be taught to use and follow the audio and visual feedback to optimize their CPR performance. After training, the raw data collected by the accelerometer will be used as a demonstration and training tool, to correct the subjects' performance by visually demonstrating the difference between ideal and suboptimal CPR performance. Testing will be carried out with the use of a feedback defibrillator."
11061042|NCT01361919|EG001|Reported Event|Feedback During CPR Training Not Testing|"A feedback defibrillator will be used for teaching, with a standard no feedback defibrillator used at immediate and 12 week (retention) testing to assess if the techniques the students' learned during training are transferable to devices without feedback. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. Participants will be taught to use and follow the audio and visual feedback provided by the accelerometer and defibrillator to optimize their CPR perfor"
11061043|NCT01361919|EG002|Reported Event|No Feedback Group|"A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur.~No Feedback during CPR Testing or Training: A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest."
11061044|NCT01362049|BG000|Baseline|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-match treatment"
11061045|NCT01362049|BG001|Baseline|'Eligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
11061046|NCT01362049|BG002|Baseline|'Ineligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received MSI-match treatment"
11061047|NCT01362049|BG003|Baseline|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
11061048|NCT01362049|BG004|Baseline|Total|Total of all reporting groups
11061049|NCT01362049|FG000|Participant Flow|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI match treatment"
11061050|NCT01362049|FG001|Participant Flow|'Eligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
11061051|NCT01362049|FG002|Participant Flow|'Ineligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received MSI- matched treatment"
11061052|NCT01362049|FG003|Participant Flow|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
11061053|NCT01362049|OG000|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
11066857|NCT01393990|EG010|Reported Event|Part A: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11149510|NCT01871142|OG002|Outcome|1000mg Aes-103 + Hypoxia|"Number of participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
11061054|NCT01362049|OG001|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
11061055|NCT01362049|OG002|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
11061056|NCT01362049|OG003|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
11061057|NCT01362049|OG000|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
11061058|NCT01362049|OG002|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
11061059|NCT01362049|OG000|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
11061060|NCT01362049|OG002|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises
11061061|NCT01362049|EG000|Reported Event|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-matched treatment"
11061062|NCT01362049|EG001|Reported Event|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
11061063|NCT01362049|EG002|Reported Event|'Ineligible' Subject Group - MSI Treatment|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Received MSI-matched treatment
11061064|NCT01362049|EG003|Reported Event|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
11061065|NCT01362062|BG000|Baseline|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
11061066|NCT01362062|BG001|Baseline|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
11061067|NCT01362062|BG002|Baseline|Total|Total of all reporting groups
11061068|NCT01362062|FG000|Participant Flow|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
11061069|NCT01362062|FG001|Participant Flow|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
11061070|NCT01362062|OG000|Outcome|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
11061071|NCT01362062|OG000|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
10887140|NCT00499031|OG000|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
11061072|NCT01362062|EG000|Reported Event|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
11061073|NCT01362127|BG000|Baseline|Radiochemotherapy|"Radiochemotherapy + Surgery~Radiochemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values."
11061074|NCT01362127|BG001|Baseline|Chemotherapy|"Chemotherapy + surgery~Chemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.~Radiochemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values."
11061075|NCT01362127|BG002|Baseline|Total|Total of all reporting groups
11061076|NCT01362127|FG000|Participant Flow|Radiochemotherapy|"Radiochemotherapy + Surgery~Radiochemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values."
11061077|NCT01362127|FG001|Participant Flow|Chemotherapy|"Chemotherapy + surgery~Chemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.~Radiochemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values."
11061078|NCT01362127|OG000|Outcome|Radiochemotherapy|"Radiochemotherapy + Surgery~Radiochemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values."
11061079|NCT01362127|OG001|Outcome|Chemotherapy|"Chemotherapy + surgery~Chemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.~Radiochemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values."
11061080|NCT01362127|EG000|Reported Event|Radiochemotherapy|"Radiochemotherapy + Surgery~Radiochemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values."
11061081|NCT01362127|EG001|Reported Event|Chemotherapy|"Chemotherapy + surgery~Chemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.~Radiochemotherapy: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values."
11061082|NCT01362140|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
10847108|NCT00281684|FG003|Participant Flow|Co-Codamol|Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol European Pharmacopoeia [Ph Eur] 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
11061083|NCT01362140|BG001|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
11061084|NCT01362140|BG002|Baseline|Total|Total of all reporting groups
11061085|NCT01362140|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
11061086|NCT01362140|FG001|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
11061087|NCT01362140|OG000|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
11061088|NCT01362140|OG001|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
11061089|NCT01362140|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
10847109|NCT00281684|OG000|Outcome|Placebo|Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
11061090|NCT01362140|EG001|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
11061091|NCT01362192|BG000|Baseline|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
11061092|NCT01362192|FG000|Participant Flow|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
11061093|NCT01362192|OG000|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
11061094|NCT01362192|EG000|Reported Event|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
11061095|NCT01362205|BG000|Baseline|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
11061096|NCT01362205|BG001|Baseline|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
11061097|NCT01362205|BG002|Baseline|Total|Total of all reporting groups
11061098|NCT01362205|FG000|Participant Flow|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
11061099|NCT01362205|FG001|Participant Flow|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
11149511|NCT01871142|OG003|Outcome|3000mg Aes-103 + Hypoxia|"Number of participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
11061100|NCT01362205|OG000|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
11061101|NCT01362205|OG001|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
11061102|NCT01362205|EG000|Reported Event|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
11061103|NCT01362205|EG001|Reported Event|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
11061104|NCT01362244|BG000|Baseline|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
11061105|NCT01362244|BG001|Baseline|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
11061106|NCT01362244|BG002|Baseline|Total|Total of all reporting groups
11061107|NCT01362244|FG000|Participant Flow|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
11061108|NCT01362244|FG001|Participant Flow|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
11061109|NCT01362244|OG000|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
11061110|NCT01362244|OG001|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
11061111|NCT01362244|EG000|Reported Event|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
11061112|NCT01362244|EG001|Reported Event|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
11061113|NCT01362270|BG000|Baseline|Verum Acupuncture|"Subjects will receive acupuncture using real acupuncture needles.~Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days"
11061114|NCT01362270|BG001|Baseline|Sham Acupuncture|"Subjects will receive sham acupuncture therapy using the Streitberger needle at the same points and on the same schedule as patients in the treatment group. Streitberger needles are blunt tipped and retract into themselves rather than penetrating the skin.~Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days"
11061115|NCT01362270|BG002|Baseline|Total|Total of all reporting groups
11061116|NCT01362270|FG000|Participant Flow|Verum Acupuncture|"Subjects will receive acupuncture using real acupuncture needles.~Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days"
11061117|NCT01362270|FG001|Participant Flow|Sham Acupuncture|"Subjects will receive sham acupuncture therapy using the Streitberger needle at the same points and on the same schedule as patients in the treatment group. Streitberger needles are blunt tipped and retract into themselves rather than penetrating the skin.~Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days"
11061118|NCT01362270|OG000|Outcome|Verum Acupuncture|"Subjects will receive acupuncture using real acupuncture needles.~Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days"
11061119|NCT01362270|OG001|Outcome|Sham Acupuncture|"Subjects will receive sham acupuncture therapy using the Streitberger needle at the same points and on the same schedule as patients in the treatment group. Streitberger needles are blunt tipped and retract into themselves rather than penetrating the skin.~Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days"
11061120|NCT01362270|EG000|Reported Event|Verum Acupuncture|"Subjects will receive acupuncture using real acupuncture needles.~Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days"
11061121|NCT01362270|EG001|Reported Event|Sham Acupuncture|"Subjects will receive sham acupuncture therapy using the Streitberger needle at the same points and on the same schedule as patients in the treatment group. Streitberger needles are blunt tipped and retract into themselves rather than penetrating the skin.~Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days"
11061122|NCT01362296|BG000|Baseline|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
11061123|NCT01362296|BG001|Baseline|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
11061124|NCT01362296|BG002|Baseline|Total|Total of all reporting groups
11061125|NCT01362296|FG000|Participant Flow|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
11061126|NCT01362296|FG001|Participant Flow|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
11061127|NCT01362296|FG002|Participant Flow|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
11061128|NCT01362296|FG003|Participant Flow|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
11061129|NCT01362296|OG000|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
11061130|NCT01362296|OG001|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
11061131|NCT01362296|OG000|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
11061132|NCT01362296|OG001|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
11061133|NCT01362296|EG000|Reported Event|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced.
11061134|NCT01362296|EG001|Reported Event|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced.
11061135|NCT01362296|EG002|Reported Event|GSK1120212 2 mg in CP|Participants who experienced disease progression in the RP were given the option of crossing over to GSK1120212 2 mg and continuing in the Cross-over Phase (CP).
11061136|NCT01362296|EG003|Reported Event|Docetaxel 75 mg/m^2 in CP|Participants who experienced disease progression in the RP were given the option of crossing over to docetaxel 75 mg/m^2 and continuing in the CP.
11061137|NCT01362322|BG000|Baseline|Boostrix New Group|Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
11061138|NCT01362322|BG001|Baseline|Boostrix Prev Group|Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
11061139|NCT01362322|BG002|Baseline|Total|Total of all reporting groups
11061140|NCT01362322|FG000|Participant Flow|Boostrix New Group|Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
11061141|NCT01362322|FG001|Participant Flow|Boostrix Prev Group|Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
11061142|NCT01362322|OG000|Outcome|Boostrix New Group|Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
11061143|NCT01362322|OG001|Outcome|Boostrix Prev Group|Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
11061144|NCT01362322|EG000|Reported Event|Boostrix New Group|Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
11061145|NCT01362322|EG001|Reported Event|Boostrix Prev Group|Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
11061146|NCT01362348|BG000|Baseline|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
11061147|NCT01362348|FG000|Participant Flow|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 micro liters ) of the pazopanib ophthalmic solution 10 milligram per millimeter (mg/mL) via topical ocular route to the study eye at approximate 5 hour intervals four times a day (QID) during the non-sleep period for a duration of 12 weeks.
11061148|NCT01362348|OG000|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
11061149|NCT01362348|EG000|Reported Event|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
11061150|NCT01362439|BG000|Baseline|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
11061151|NCT01362439|FG000|Participant Flow|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
11061152|NCT01362439|OG000|Outcome|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
11061153|NCT01362439|OG000|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
11061154|NCT01362439|EG000|Reported Event|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
11061155|NCT01362491|BG000|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11061156|NCT01362491|BG001|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061157|NCT01362491|BG002|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061158|NCT01362491|BG003|Baseline|Total|Total of all reporting groups
11061159|NCT01362491|FG000|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11061160|NCT01362491|FG001|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061161|NCT01362491|FG002|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061162|NCT01362491|OG000|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11061163|NCT01362491|OG001|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061164|NCT01362491|OG001|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061165|NCT01362491|OG002|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061166|NCT01362491|EG000|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
11061167|NCT01362491|EG001|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061168|NCT01362491|EG002|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
11061169|NCT01362517|BG000|Baseline|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
11061170|NCT01362517|FG000|Participant Flow|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
11061171|NCT01362517|OG000|Outcome|Quinvaxem|
11061172|NCT01362517|OG000|Outcome|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
11061173|NCT01362517|EG000|Reported Event|First Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 2 months of age"
11061174|NCT01362517|EG001|Reported Event|Second Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 3 months of age"
11061175|NCT01362517|EG002|Reported Event|Third Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 4 months of age"
11061176|NCT01362530|BG000|Baseline|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
11061177|NCT01362530|BG001|Baseline|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
11061178|NCT01362530|BG002|Baseline|Total|Total of all reporting groups
11061179|NCT01362530|FG000|Participant Flow|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
11061180|NCT01362530|FG001|Participant Flow|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
11061181|NCT01362530|OG000|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
11061182|NCT01362530|OG001|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
11061183|NCT01362530|EG000|Reported Event|Aprepitant Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
11061184|NCT01362530|EG001|Reported Event|Control Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg).
11061185|NCT01362530|EG002|Reported Event|Aprepitant Regimen Cycles 2-6|Participants completing Cycle 1 from either the aprepitant or the control regimen who meet eligibility criteria: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
11061186|NCT01362608|BG000|Baseline|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
11061187|NCT01362608|BG001|Baseline|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
11061188|NCT01362608|BG002|Baseline|Total|Total of all reporting groups
11061189|NCT01362608|FG000|Participant Flow|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
11061190|NCT01362608|FG001|Participant Flow|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
11061191|NCT01362608|OG000|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
11061192|NCT01362608|OG001|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
11061193|NCT01362608|EG000|Reported Event|ACZ885 150mg sc|ACZ885 150mg sc
11061194|NCT01362608|EG001|Reported Event|Triam 40mg im|Triam 40mg im
11066858|NCT01393990|EG011|Reported Event|Part A: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066859|NCT01393990|EG012|Reported Event|Part A: 420 mg LY2228820 Tablets|420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066860|NCT01393990|EG013|Reported Event|Part A: 560 mg LY2228820 Tablets|560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
11066861|NCT01393990|EG014|Reported Event|Part B: 420 mg LY2228820 Tablets|420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
11066862|NCT01393990|EG015|Reported Event|Part C: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
11066863|NCT01393990|EG016|Reported Event|Part D: 200 mg LY2228820 Tablets|200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11066864|NCT01393990|EG017|Reported Event|Part D: 300 mg LY2228820 Tablets|300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
11066865|NCT01394003|BG000|Baseline|25 mg LY2584702 QD|Participants received 25 milligrams (mg) of LY2584702 orally as a capsule, once daily (QD) for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066866|NCT01394003|BG001|Baseline|50 mg LY2584702 QD|Participants received 50 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066867|NCT01394003|BG002|Baseline|100 mg LY2584702 QD|Participants received 100 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066868|NCT01394003|BG003|Baseline|200 mg LY2584702 QD|Participants received 200 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066869|NCT01394003|BG004|Baseline|50 mg LY2584702 BID|Participants received 50 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066870|NCT01394003|BG005|Baseline|75 mg LY2584702 BID|Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066871|NCT01394003|BG006|Baseline|100 mg LY2584702 BID|Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066872|NCT01394003|BG007|Baseline|300 mg LY2584702 BID|Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066873|NCT01394003|BG008|Baseline|Total|Total of all reporting groups
11066874|NCT01394003|FG000|Participant Flow|25 mg LY2584702 QD|Participants received 25 milligrams (mg) of LY2584702 orally as a capsule, once daily (QD) for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066875|NCT01394003|FG001|Participant Flow|50 mg LY2584702 QD|Participants received 50 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066876|NCT01394003|FG002|Participant Flow|100 mg LY2584702 QD|Participants received 100 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066877|NCT01394003|FG003|Participant Flow|200 mg LY2584702 QD|Participants received 200 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066878|NCT01394003|FG004|Participant Flow|50 mg LY2584702 BID|Participants received 50 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066879|NCT01394003|FG005|Participant Flow|75 mg LY2584702 BID|Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066880|NCT01394003|FG006|Participant Flow|100 mg LY2584702 BID|Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066881|NCT01394003|FG007|Participant Flow|300 mg LY2584702 BID|Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061195|NCT01362686|BG000|Baseline|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061196|NCT01362686|BG001|Baseline|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061197|NCT01362686|BG002|Baseline|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061198|NCT01362686|BG003|Baseline|Total|Total of all reporting groups
11061199|NCT01362686|FG000|Participant Flow|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061200|NCT01362686|FG001|Participant Flow|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061201|NCT01362686|FG002|Participant Flow|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061202|NCT01362686|OG000|Outcome|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061203|NCT01362686|OG001|Outcome|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061204|NCT01362686|OG002|Outcome|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061205|NCT01362686|EG000|Reported Event|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061206|NCT01362686|EG001|Reported Event|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061207|NCT01362686|EG002|Reported Event|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
11061208|NCT01362790|BG000|Baseline|Mesothelioma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11066882|NCT01394003|OG000|Outcome|Part A|Participants received 25 mg, 50 mg, 100 mg and 200 mg once daily (QD) and 300 mg twice daily (BID) of LY2584702 capsule, for a 28-day cycle during Part A of the study until the criteria for maximum tolerated dose (MTD) were met.
11066883|NCT01394003|OG001|Outcome|Part B|Participants received 50 mg, 75 mg and 100 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until the criteria for maximum tolerated dose (MTD) were met.
10887141|NCT00499031|EG000|Reported Event|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
11061209|NCT01362790|BG001|Baseline|Mesothelioma Pilot Phase Regimen B|"Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles."
11061210|NCT01362790|BG002|Baseline|Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061211|NCT01362790|BG003|Baseline|Phase 2 Pleural Mesothelioma Pilot Expansion Phase|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061212|NCT01362790|BG004|Baseline|Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061213|NCT01362790|BG005|Baseline|Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061214|NCT01362790|BG006|Baseline|Total|Total of all reporting groups
11061215|NCT01362790|FG000|Participant Flow|Mesothelioma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061216|NCT01362790|FG001|Participant Flow|Mesothelioma Pilot Phase Regimen B|"Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles."
11061217|NCT01362790|FG002|Participant Flow|Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061218|NCT01362790|FG003|Participant Flow|Phase 2 Pleural Mesothelioma Pilot Expansion Phase|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061219|NCT01362790|FG004|Participant Flow|Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.~During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot."
11061220|NCT01362790|FG005|Participant Flow|Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061221|NCT01362790|FG006|Participant Flow|Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061222|NCT01362790|OG000|Outcome|Mesothelioma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061223|NCT01362790|OG001|Outcome|Mesothelioma Pilot Phase Regimen|"Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles."
11061224|NCT01362790|OG002|Outcome|Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061225|NCT01362790|OG003|Outcome|Phase 2 Pleural Mesothelioma Pilot Expansion Phase|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061226|NCT01362790|OG004|Outcome|Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061227|NCT01362790|OG005|Outcome|Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061228|NCT01362790|OG001|Outcome|Mesothelioma Pilot Phase Regimen B|"Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles."
11061229|NCT01362790|OG000|Outcome|Meso., Peritoneal, Pleural & Pancreatic Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan~Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.~During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot."
11061230|NCT01362790|OG000|Outcome|Mesothelioma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles"
11061231|NCT01362790|OG000|Outcome|Meothelioma Pilot Phase Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles"
11061232|NCT01362790|OG001|Outcome|Meothelioma Pilot Phase Regimen B|"Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles."
11061233|NCT01362790|EG000|Reported Event|Mesothelioma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11066884|NCT01394003|OG000|Outcome|25 mg LY2584702 QD|Participants received 25 milligrams (mg) of LY2584702 orally as a capsule, once daily (QD) for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061234|NCT01362790|EG001|Reported Event|Mesothelioma Pilot Phase Regimen B|"Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle~Other Names:~• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles."
11061235|NCT01362790|EG002|Reported Event|Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061236|NCT01362790|EG003|Reported Event|Phase 2 Pleural Mesothelioma Pilot Expansion Phase|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061237|NCT01362790|EG004|Reported Event|Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles~During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot."
11061238|NCT01362790|EG005|Reported Event|Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061239|NCT01362790|EG006|Reported Event|Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A|"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle~Other Names:~• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles."
11061240|NCT01362894|BG000|Baseline|Overall|All enrolled and dispensed participants.
11061241|NCT01362894|FG000|Participant Flow|Nelfilcon A / Etafilcon A|Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
11061242|NCT01362894|FG001|Participant Flow|Etafilcon A / Nelfilcon A|Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
11061243|NCT01362894|OG000|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
11061244|NCT01362894|OG001|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
11061245|NCT01362894|EG000|Reported Event|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
11061246|NCT01362894|EG001|Reported Event|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
11061247|NCT01362907|BG000|Baseline|Overall|All enrolled participants
11061248|NCT01362907|FG000|Participant Flow|Delefilcon A / Etafilcon A|Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
11061249|NCT01362907|FG001|Participant Flow|Etafilcon A / Delefilcon A|Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
11061250|NCT01362907|OG000|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
11061251|NCT01362907|OG001|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
11061252|NCT01362907|EG000|Reported Event|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
11061253|NCT01362907|EG001|Reported Event|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
11061254|NCT01362946|BG000|Baseline|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
11061255|NCT01362946|FG000|Participant Flow|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
11066885|NCT01394003|OG001|Outcome|50 mg LY2584702 QD|Participants received 50 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061256|NCT01362946|FG001|Participant Flow|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
11061257|NCT01362946|OG000|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
11061258|NCT01362946|OG000|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
11061259|NCT01362946|EG000|Reported Event|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
11061260|NCT01362946|EG001|Reported Event|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
11061261|NCT01362959|BG000|Baseline|Nicotine Patch|Transdermal nicotine patch: The test product is a transdermal nicotine patch. The dosage of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applied daily.
11061262|NCT01362959|BG001|Baseline|Control Patch|The control product is a look-alike cutaneous patch comparable to the test product, containing no nicotine or other active substances. During the study period of thirty (30) days, the control product will be applied daily.
11061263|NCT01362959|BG002|Baseline|Total|Total of all reporting groups
11061264|NCT01362959|FG000|Participant Flow|Nicotine Patch|Transdermal nicotine patch: The test product is a transdermal nicotine patch. The dose of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applied daily.
11061265|NCT01362959|FG001|Participant Flow|Control Patch|The control product is a look-alike cutaneous patch comparable to the test product, containing no nicotine or other active substances. During the study period of thirty (30) days, the control product will be applied daily.
11061266|NCT01362959|OG000|Outcome|Nicotine Replacement|
11061267|NCT01362959|OG001|Outcome|Control|
11061268|NCT01362959|EG000|Reported Event|Nicotine Replacement|
11061269|NCT01362959|EG001|Reported Event|Control|
11061270|NCT01363011|BG000|Baseline|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
11061271|NCT01363011|BG001|Baseline|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
11061272|NCT01363011|BG002|Baseline|Total|Total of all reporting groups
11061273|NCT01363011|FG000|Participant Flow|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior antiretroviral (ARV) treatment and who were virologically unsuppressed at baseline initiated treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
11061274|NCT01363011|FG001|Participant Flow|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to cobicistat (Tybost®; COBI) 150 mg, while continuing the other components of their ARV regimen (atazanavir (ATV) 300 mg or darunavir (DRV) 800 mg plus 2 nucleoside reverse transcriptase inhibitors (NRTI)) for up to 96 weeks. These 2 NRTIs may have included abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF), administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
10887352|NCT00499915|EG000|Reported Event|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
11061275|NCT01363011|OG000|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
11061276|NCT01363011|OG000|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
11061277|NCT01363011|EG000|Reported Event|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
11061278|NCT01363011|EG001|Reported Event|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTI) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
11061279|NCT01363050|BG000|Baseline|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
11061280|NCT01363050|FG000|Participant Flow|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
11061281|NCT01363050|OG000|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
11061282|NCT01363050|OG000|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
11061283|NCT01363050|OG000|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
11061284|NCT01363050|EG000|Reported Event|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
11061285|NCT01363076|BG000|Baseline|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
11061286|NCT01363076|BG001|Baseline|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
11061287|NCT01363076|BG002|Baseline|Total|Total of all reporting groups
11061288|NCT01363076|FG000|Participant Flow|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
11061289|NCT01363076|FG001|Participant Flow|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
11061290|NCT01363076|OG000|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
11061291|NCT01363076|OG001|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
11061292|NCT01363076|EG000|Reported Event|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
11061293|NCT01363076|EG001|Reported Event|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
11061294|NCT01363128|BG000|Baseline|Treatment (Hyper-CVAD, Ofatumumab)|"COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide IV over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or PO QD on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.~COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.~Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Ofatumumab: Given IV~Vincristine Sulfate: Given IV"
11066886|NCT01394003|OG002|Outcome|100 mg LY2584702 QD|Participants received 100 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066887|NCT01394003|OG003|Outcome|200 mg LY2584702 QD|Participants received 200 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066888|NCT01394003|OG004|Outcome|50 mg LY2584702 BID|Participants received 50 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061295|NCT01363128|FG000|Participant Flow|Treatment (Hyper-CVAD, Ofatumumab)|"COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide IV over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or PO QD on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.~COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.~Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Ofatumumab: Given IV~Vincristine Sulfate: Given IV"
11061296|NCT01363128|OG000|Outcome|Treatment (Hyper-CVAD, Ofatumumab)|"COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide IV over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or PO QD on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.~COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.~Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Ofatumumab: Given IV~Vincristine Sulfate: Given IV"
11061297|NCT01363128|EG000|Reported Event|Treatment (Hyper-CVAD, Ofatumumab)|"COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide IV over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or PO QD on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.~COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.~Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Ofatumumab: Given IV~Vincristine Sulfate: Given IV"
11061298|NCT01363258|BG000|Baseline|Control|Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse.
11061299|NCT01363258|BG001|Baseline|Experimental|The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures [all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care.
11061300|NCT01363258|BG002|Baseline|Total|Total of all reporting groups
11061301|NCT01363258|FG000|Participant Flow|Control|Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse.
11061302|NCT01363258|FG001|Participant Flow|Experimental|The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures [all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care.
11061303|NCT01363258|OG000|Outcome|Control|Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse.
11061304|NCT01363258|OG001|Outcome|Experimental|The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures [all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care.
11061305|NCT01363258|EG000|Reported Event|Control|Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse.
11061306|NCT01363258|EG001|Reported Event|Experimental|The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures [all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care.
11061307|NCT01363297|BG000|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
11061308|NCT01363297|BG001|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061309|NCT01363297|BG002|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061310|NCT01363297|BG003|Baseline|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061311|NCT01363297|BG004|Baseline|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061312|NCT01363297|BG005|Baseline|Total|Total of all reporting groups
11061313|NCT01363297|FG000|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
11061314|NCT01363297|FG001|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061315|NCT01363297|FG002|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061316|NCT01363297|FG003|Participant Flow|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061317|NCT01363297|FG004|Participant Flow|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061318|NCT01363297|OG000|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
11061319|NCT01363297|OG001|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061320|NCT01363297|OG002|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061321|NCT01363297|OG000|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061322|NCT01363297|OG000|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061323|NCT01363297|OG003|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061324|NCT01363297|OG004|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061325|NCT01363297|OG005|Outcome|All Doses|
11061326|NCT01363297|OG000|Outcome|All Doses|
11061327|NCT01363297|OG000|Outcome|Pharmacogenomics Population|All participants who gave consent for the optional blood sample for pharmacogenomic analyses, received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.
11061328|NCT01363297|EG000|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
11061329|NCT01363297|EG001|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061330|NCT01363297|EG002|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061331|NCT01363297|EG003|Reported Event|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061332|NCT01363297|EG004|Reported Event|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
11061333|NCT01363349|BG000|Baseline|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
11061334|NCT01363349|BG001|Baseline|Risperidone|"2-6 mg, 6 months~Risperidone"
11061335|NCT01363349|BG002|Baseline|Total|Total of all reporting groups
11061336|NCT01363349|FG000|Participant Flow|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
11061337|NCT01363349|FG001|Participant Flow|Risperidone|"2-6 mg, 6 months~Risperidone"
11061338|NCT01363349|OG000|Outcome|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
11061339|NCT01363349|OG001|Outcome|Risperidone|"2-6 mg, 6 months~Risperidone"
11061340|NCT01363349|EG000|Reported Event|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
11061341|NCT01363349|EG001|Reported Event|Risperidone|"2-6 mg, 6 months~Risperidone"
11061342|NCT01363388|BG000|Baseline|Placebo BID Plus 60 mg Prednisone|
11061343|NCT01363388|BG001|Baseline|Avacopan 30 mg BID Plus 20 mg Prednisone|
11061344|NCT01363388|BG002|Baseline|Avacopan 30 mg BID Without Prednisone|
11061345|NCT01363388|BG003|Baseline|Total|Total of all reporting groups
11061346|NCT01363388|FG000|Participant Flow|Placebo BID Plus 60 mg Prednisone|
11061347|NCT01363388|FG001|Participant Flow|CCX168 30 mg BID Plus 20 mg Prednisone|
11061348|NCT01363388|FG002|Participant Flow|CCX168 30 mg BID Without Prednisone|
11061349|NCT01363388|OG000|Outcome|Placebo BID Plus 60 mg Prednisone|
11061350|NCT01363388|OG001|Outcome|CCX168 30 mg BID Plus 20 mg Prednisone|
11061351|NCT01363388|OG002|Outcome|CCX168 30 mg BID Without Prednisone|
11061352|NCT01363388|EG000|Reported Event|Placebo BID Plus 60 mg Prednisone|
11061353|NCT01363388|EG001|Reported Event|Avacopan 30 mg BID Plus 20 mg Prednisone|
11061354|NCT01363388|EG002|Reported Event|Avacopan 30 mg BID Without Prednisone|
11061355|NCT01363440|BG000|Baseline|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
11061356|NCT01363440|BG001|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
11061357|NCT01363440|BG002|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
11061358|NCT01363440|BG003|Baseline|Total|Total of all reporting groups
11061359|NCT01363440|FG000|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
11061360|NCT01363440|FG001|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
11061361|NCT01363440|FG002|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
11061362|NCT01363440|OG000|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
11061363|NCT01363440|OG001|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
11061364|NCT01363440|OG002|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
11061365|NCT01363440|EG000|Reported Event|Control (Week 0 to Week 100)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
11061366|NCT01363440|EG001|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
11061367|NCT01363440|EG002|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
11061368|NCT01363440|EG003|Reported Event|Control (Week 0 to Week 148)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
11061369|NCT01363440|EG004|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection(IAI) every 4 weeks.
11061370|NCT01363440|EG005|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
11061371|NCT01363479|BG000|Baseline|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
11061372|NCT01363479|BG001|Baseline|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
11061373|NCT01363479|BG002|Baseline|Total|Total of all reporting groups
11061374|NCT01363479|FG000|Participant Flow|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
11061375|NCT01363479|FG001|Participant Flow|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
11061376|NCT01363479|OG000|Outcome|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
11061377|NCT01363479|OG001|Outcome|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
11061378|NCT01363479|EG000|Reported Event|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
11061379|NCT01363479|EG001|Reported Event|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
11061380|NCT01363492|BG000|Baseline|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
11061381|NCT01363492|FG000|Participant Flow|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
11061382|NCT01363492|OG000|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
11061383|NCT01363492|OG000|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
11061384|NCT01363492|OG000|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
11061385|NCT01363492|EG000|Reported Event|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
11061386|NCT01363661|BG000|Baseline|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
11061387|NCT01363661|BG001|Baseline|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
11061388|NCT01363661|BG002|Baseline|Total|Total of all reporting groups
11061389|NCT01363661|FG000|Participant Flow|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
11061390|NCT01363661|FG001|Participant Flow|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
11061391|NCT01363661|OG000|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
11061392|NCT01363661|OG001|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
11061393|NCT01363661|EG000|Reported Event|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
11061394|NCT01363661|EG001|Reported Event|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
11061395|NCT01363700|BG000|Baseline|Epinastine / Placebo Period1|Epinastine / Placebo : DE-114 ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
11061396|NCT01363700|BG001|Baseline|Epinastine / Epinastine Period1|Epinastine / Epinastine : DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
11061397|NCT01363700|BG002|Baseline|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
11061398|NCT01363700|BG003|Baseline|Total|Total of all reporting groups
11061399|NCT01363700|FG000|Participant Flow|Epinastine / Placebo Period1|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
11061400|NCT01363700|FG001|Participant Flow|Epinastine / Epinastine Period1|Epinastine / Epinastine : Epinastine ophthalmic solution, 1 drop in each eye at designated visits.
11061401|NCT01363700|FG002|Participant Flow|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
11061402|NCT01363700|FG003|Participant Flow|Olopatadine / Placebo Period2|Olopatadine / Placebo : Olopatadine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
11061403|NCT01363700|FG004|Participant Flow|Epinastine / Placebo Period2|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
11061404|NCT01363700|OG000|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
11061405|NCT01363700|OG001|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
11061406|NCT01363700|OG001|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
11061407|NCT01363700|OG002|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
11061408|NCT01363700|EG000|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period1|Count unit was defined each eye.
11061409|NCT01363700|EG001|Reported Event|Placebo Ophthalmic Solution Period1|Count unit was defined each eye.
11061410|NCT01363700|EG002|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period2|Count unit was defined each eye.
11061411|NCT01363700|EG003|Reported Event|Olopatadine Ophthalmic Solution Period2|Count unit was defined each eye.
11061412|NCT01363700|EG004|Reported Event|Placebo Ophthalmic Solution Period2|Count unit was defined each eye.
11061413|NCT01363713|BG000|Baseline|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
11061414|NCT01363713|FG000|Participant Flow|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
11061415|NCT01363713|OG000|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
11061416|NCT01363713|EG000|Reported Event|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
11061417|NCT01363765|BG000|Baseline|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
11061418|NCT01363765|BG001|Baseline|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
11061419|NCT01363765|BG002|Baseline|Total|Total of all reporting groups
11061420|NCT01363765|FG000|Participant Flow|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
11061421|NCT01363765|FG001|Participant Flow|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
11061422|NCT01363765|OG000|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period was submitted to this technology
11061423|NCT01363765|OG001|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
11061424|NCT01363765|OG000|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
11061425|NCT01363765|OG001|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
11061426|NCT01363765|EG000|Reported Event|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
11061427|NCT01363765|EG001|Reported Event|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
11061428|NCT01363843|BG000|Baseline|Study Arm|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
11061429|NCT01363843|FG000|Participant Flow|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
11061430|NCT01363843|OG000|Outcome|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
11061431|NCT01363843|OG000|Outcome|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
11061432|NCT01363843|EG000|Reported Event|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
11061433|NCT01363908|BG000|Baseline|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
11061434|NCT01363908|BG001|Baseline|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
11061435|NCT01363908|BG002|Baseline|Total|Total of all reporting groups
11061436|NCT01363908|FG000|Participant Flow|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
11066889|NCT01394003|OG005|Outcome|75 mg LY2584702 BID|Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061437|NCT01363908|FG001|Participant Flow|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
11061438|NCT01363908|OG000|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
11061439|NCT01363908|OG001|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
11061440|NCT01363908|EG000|Reported Event|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
11061441|NCT01363908|EG001|Reported Event|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
11061442|NCT01363986|BG000|Baseline|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
11061443|NCT01363986|FG000|Participant Flow|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenously (i.v.) on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
11061444|NCT01363986|OG000|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
11061445|NCT01363986|EG000|Reported Event|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
11061446|NCT01363999|BG000|Baseline|Total Study|All AE and Demographic Data is listed for the Total Study Population
11061447|NCT01363999|FG000|Participant Flow|Total Study|All AE and Demographic Data is listed for the Total Study Population
11061448|NCT01363999|OG000|Outcome|A, RO5317116/F01 Bilayer Tablet|"RO5317116/F01 bilayer tablet~atorvastatin: single dose of atorvastatin on day 1~dalcetrapib: single dose of dalcetrapib on day 1"
11061449|NCT01363999|OG001|Outcome|B, RO5317116/F03 Bilayer Tablet|"RO5317116/F03 bilayer tablet~atorvastatin: single dose of atorvastatin on day 1~dalcetrapib: single dose of dalcetrapib on day 1"
11061450|NCT01363999|OG002|Outcome|C, RO5317116/F04 Active-coated Tablet|"RO5317116/F04 active-coated tablet~atorvastatin: single dose of atorvastatin on day 1~dalcetrapib: single dose of dalcetrapib on day 1"
11061451|NCT01363999|OG003|Outcome|D, RO4607381/F49 Tablet|"RO4607381/F49 tablet~atorvastatin: single dose of atorvastatin on day 1~dalcetrapib: single dose of dalcetrapib on day 1"
11349039|NCT04128293|FG000|Participant Flow|Sequence 1 - Treatment ABCD|Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 4. Treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
11349040|NCT04128293|FG001|Participant Flow|Sequence 2 - Treatment BADC|Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
10847110|NCT00281684|OG001|Outcome|SB705498 400 mg|Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
10847111|NCT00281684|OG002|Outcome|SB705498 1000 mg|Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
11061452|NCT01363999|EG000|Reported Event|Total Study|All AE and Demographic Data is listed for the Total Study Population. Data was not collected by arm since all interventions contained the same formulation.
11061453|NCT01364090|BG000|Baseline|Standard Treatment Duration (24 Weeks)|"Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
11066890|NCT01394003|OG006|Outcome|100 mg LY2584702 BID|Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061454|NCT01364090|BG001|Baseline|Shortened Treatment Duration (12 Weeks)|"Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
11061455|NCT01364090|BG002|Baseline|Discontinued Prior to RVR|Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
11061456|NCT01364090|BG003|Baseline|Total|Total of all reporting groups
11061457|NCT01364090|FG000|Participant Flow|Shortened Treatment Duration (12 Weeks)|"Subjects with undetectable HCV RNA after four weeks of therapy will continue on pegylated interferon alfa 2b (PEG-IFN) and ribavirin (RBV) until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
11061458|NCT01364090|FG001|Participant Flow|Standard Treatment Duration (24 Weeks)|"Subjects with detectable HCV RNA after four weeks of therapy will continue on pegylated interferon alfa 2b (PEG-IFN) and ribavirin (RBV) until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
11061459|NCT01364090|FG002|Participant Flow|Discontinued Prior to Week 4|Participants who discontinued therapy prior to week 4 HCV RNA assessment and were therefore not placed in either study arms.
11061460|NCT01364090|OG000|Outcome|Standard Treatment Duration (24 Weeks)|"Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
11061461|NCT01364090|OG001|Outcome|Shortened Treatment Duration (12 Weeks)|"Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
11061462|NCT01364090|OG002|Outcome|Discontinued Prior to RVR|Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
11061463|NCT01364090|EG000|Reported Event|Standard Treatment Duration (24 Weeks)|"Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
11061464|NCT01364090|EG001|Reported Event|Shortened Treatment Duration (12 Weeks)|"Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
11061465|NCT01364090|EG002|Reported Event|Discontinued Prior to RVR|Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
11061466|NCT01364207|BG000|Baseline|All Participants Who Completed Both Study Visits|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.
11061467|NCT01364207|FG000|Participant Flow|Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of caffeinated coffee on the their first visit, and then an 8 oz cup of decaffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
11061468|NCT01364207|FG001|Participant Flow|Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of decaffeinated coffee on the their first visit, and then an 8 oz cup of caffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
11061469|NCT01364207|OG000|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
11061470|NCT01364207|OG001|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
11061471|NCT01364207|EG000|Reported Event|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
11061472|NCT01364207|EG001|Reported Event|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
11061473|NCT01364233|BG000|Baseline|MotifMesh|Participants received Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
11061474|NCT01364233|FG000|Participant Flow|MotifMesh|"Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh~MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh~MotifMESH: Surgical mesh"
11061475|NCT01364233|OG000|Outcome|Hernia Occurrence at One Year After Surgery|Number of subjects who had an additional hernia occur following surgery with Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh post 1 year after initial surgery.
11061476|NCT01364233|EG000|Reported Event|MotifMesh|"Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh~MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh~MotifMESH: Surgical mesh"
11061477|NCT01364259|BG000|Baseline|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery + saline"
11061478|NCT01364259|BG001|Baseline|Amifostine|"Amifostine and CyberKnife stereotactic radiosurgery~CyberKnife stereotactic radiosurgery + amofostine"
11061479|NCT01364259|BG002|Baseline|Total|Total of all reporting groups
11061480|NCT01364259|FG000|Participant Flow|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
11061481|NCT01364259|FG001|Participant Flow|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
11061482|NCT01364259|OG000|Outcome|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
11061483|NCT01364259|OG001|Outcome|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
11061484|NCT01364259|EG000|Reported Event|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
11061485|NCT01364259|EG001|Reported Event|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
11061486|NCT01364298|BG000|Baseline|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
11061487|NCT01364298|BG001|Baseline|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
11061488|NCT01364298|BG002|Baseline|Total|Total of all reporting groups
11061489|NCT01364298|FG000|Participant Flow|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
11061490|NCT01364298|FG001|Participant Flow|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
11061491|NCT01364298|OG000|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
11061492|NCT01364298|OG001|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
11061493|NCT01364298|EG000|Reported Event|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
11061494|NCT01364298|EG001|Reported Event|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
11061495|NCT01364389|BG000|Baseline|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
11061496|NCT01364389|BG001|Baseline|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
11061497|NCT01364389|BG002|Baseline|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
11061498|NCT01364389|BG003|Baseline|Total|Total of all reporting groups
11066891|NCT01394003|OG007|Outcome|300 mg LY2584702 BID|Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061499|NCT01364389|FG000|Participant Flow|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
11061500|NCT01364389|FG001|Participant Flow|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
11061501|NCT01364389|FG002|Participant Flow|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
11061502|NCT01364389|OG000|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
11061503|NCT01364389|OG001|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
11061504|NCT01364389|OG002|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
11061505|NCT01364389|EG000|Reported Event|ACZ885 3mg/kg|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
11061506|NCT01364389|EG001|Reported Event|AIN457 3mg/kg|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
11061507|NCT01364389|EG002|Reported Event|Prednisone 20mg|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
11061508|NCT01364428|BG000|Baseline|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
11061509|NCT01364428|BG001|Baseline|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
11061510|NCT01364428|BG002|Baseline|Total|Total of all reporting groups
11061511|NCT01364428|FG000|Participant Flow|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
11061512|NCT01364428|FG001|Participant Flow|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
11061513|NCT01364428|OG000|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
11061514|NCT01364428|OG001|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
11061515|NCT01364428|EG000|Reported Event|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
11061516|NCT01364428|EG001|Reported Event|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
11061517|NCT01364467|BG000|Baseline|Placebo|"Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.~Placebo: Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID."
11061518|NCT01364467|BG001|Baseline|Guaifenesin|Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
11061519|NCT01364467|BG002|Baseline|Total|Total of all reporting groups
11061520|NCT01364467|FG000|Participant Flow|Placebo|"Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.~Placebo: Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID."
11061521|NCT01364467|FG001|Participant Flow|Guaifenesin|Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
11061522|NCT01364467|OG000|Outcome|Placebo|"Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.~Placebo: Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID."
11061523|NCT01364467|OG001|Outcome|Guaifenesin|Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
11061524|NCT01364467|EG000|Reported Event|Placebo|"Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.~Placebo: Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID."
11061525|NCT01364467|EG001|Reported Event|Guaifenesin|Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
11061526|NCT01364558|BG000|Baseline|Diazepam Nasal Spray Suspension/Spray/Injection|
11061527|NCT01364558|FG000|Participant Flow|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
11061528|NCT01364558|FG001|Participant Flow|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
11061529|NCT01364558|FG002|Participant Flow|Diazepam Injection|Diazepam injection
11061530|NCT01364558|OG000|Outcome|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
11061531|NCT01364558|OG001|Outcome|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
11061532|NCT01364558|OG002|Outcome|Diazepam Injection|Diazepam injection
11061533|NCT01364558|EG000|Reported Event|Diazepam Nasal Spray Suspension|
11061534|NCT01364558|EG001|Reported Event|Diazepam Nasal Spray Solution|
11061535|NCT01364558|EG002|Reported Event|Diazepam Injection|
11061536|NCT01364584|BG000|Baseline|Exenatide|"Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months~Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)"
11061537|NCT01364584|BG001|Baseline|Placebo|"Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months~Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID"
11061538|NCT01364584|BG002|Baseline|Total|Total of all reporting groups
11061539|NCT01364584|FG000|Participant Flow|Exenatide|"Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months~Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)"
11061540|NCT01364584|FG001|Participant Flow|Placebo|"Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months~Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID"
11061541|NCT01364584|OG000|Outcome|Exenatide|"Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months~Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)"
11061542|NCT01364584|OG001|Outcome|Placebo|"Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months~Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID"
11061543|NCT01364584|OG000|Outcome|Exenatide|"Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months~Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)"
11061544|NCT01364584|OG001|Outcome|Placebo|"Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months~Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID"
11061545|NCT01364584|EG000|Reported Event|Exenatide|"Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months~Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)"
11061546|NCT01364584|EG001|Reported Event|Placebo|"Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months~Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID"
11061547|NCT01364623|BG000|Baseline|Low Dose TBS-2|Low dose testosterone nasal gel: Single dose administration
11061548|NCT01364623|BG001|Baseline|Medium Dose TBS-2|"Medium dose testosterone nasal gel: Single dose administration~Medium dose testosterone nasal gel: Multiple dose administration"
11061549|NCT01364623|BG002|Baseline|High Dose TBS-2|High dose testosterone nasal gel: Single dose administration
11061550|NCT01364623|BG003|Baseline|Total|Total of all reporting groups
11061551|NCT01364623|FG000|Participant Flow|Low Dose TBS-2 Single Dose|Low dose testosterone nasal gel: Single dose administration
11061552|NCT01364623|FG001|Participant Flow|Medium Dose TBS-2 Single Dose|Medium dose testosterone nasal gel: Single dose administration
11061553|NCT01364623|FG002|Participant Flow|High Dose TBS-2 Single Dose|High dose testosterone nasal gel: single dose administration
11061554|NCT01364623|FG003|Participant Flow|Medium Dose TBS-2 Multiple-Dose|High dose testosterone nasal gel: multiple dose administration
11061555|NCT01364623|OG000|Outcome|Low Dose TBS-2 Single Dose|Low dose testosterone nasal gel: Single dose administration
11061556|NCT01364623|OG001|Outcome|Medium Dose TBS-2 Single Dose|Medium dose testosterone nasal gel: Single dose administration
11061557|NCT01364623|OG002|Outcome|High Dose TBS-2 Single Dose|High dose testosterone nasal gel: single dose administration
11061558|NCT01364623|OG003|Outcome|Medium Dose TBS-2 Multiple-Dose|Medium dose testosterone nasal gel: Multiple dose administration
11061559|NCT01364623|OG000|Outcome|Low Dose TBS-2 - Single Dose|Low dose testosterone nasal gel: Single dose administration
11061560|NCT01364623|OG001|Outcome|Medium Dose TBS-2 - Single Dose|Medium dose testosterone nasal gel: Single dose Administration
11061561|NCT01364623|OG002|Outcome|High Dose TBS-2 - Single Dose|High dose testosterone nasal gel: single dose Administration
11061562|NCT01364623|OG003|Outcome|Medium Dose TBS-2 - Multiple Dose|Medium dose testosterone nasal gel: multiple dose administration
11061563|NCT01364623|OG000|Outcome|Medium Dose TBS-2 - Multiple Dose|"Medium dose testosterone nasal gel - multiple dose administration:~A total dose of 1200 μg given t.i.d. daily at 0800 hours (± 30 minutes), 1600 hours (± 30 minutes), and 2400 hours (± 30 minutes) on Days 1 and 2 of Period 2, and once in the morning at 0800 hours (± 30 minutes) on Day 3 of Period 2)."
11061564|NCT01364623|EG000|Reported Event|Low Dose TBS-2 Single Dose|Low dose testosterone nasal gel: Single dose administration
11061565|NCT01364623|EG001|Reported Event|Medium Dose TBS-2 Single Dose|Medium dose testosterone nasal gel: Single dose Administration
11061566|NCT01364623|EG002|Reported Event|High Dose TBS-2 Single Dose|High dose testosterone nasal gel: single dose Administration
11061567|NCT01364623|EG003|Reported Event|Medium Dose TBS-2 Multiple Dose|Medium dose testosterone nasal gel: multiple dose administration
11061568|NCT01364649|BG000|Baseline|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
11061569|NCT01364649|BG001|Baseline|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
11061570|NCT01364649|BG002|Baseline|Total|Total of all reporting groups
11061571|NCT01364649|FG000|Participant Flow|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
11061572|NCT01364649|FG001|Participant Flow|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
11061573|NCT01364649|OG000|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
11061574|NCT01364649|OG001|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
11061575|NCT01364649|EG000|Reported Event|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
11061576|NCT01364649|EG001|Reported Event|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
11061577|NCT01364727|BG000|Baseline|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
11061578|NCT01364727|FG000|Participant Flow|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
11061579|NCT01364727|OG000|Outcome|Amrubicin|
11061580|NCT01364727|OG000|Outcome|Amrubicin|Amrubicin 35mg/m2 IV days 1 to 3 every 3 weeks until progression or toxicity
11061581|NCT01364727|OG000|Outcome|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
11061582|NCT01364727|EG000|Reported Event|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
11061583|NCT01364740|BG000|Baseline|PMP-300E, In-Lab PSG|"PMP-300E, In-Lab PSG: PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)~PMP-300E: Data collected from Level 3 device~In-lab PSG: Data collected from Type I In-Lab Polysomnography"
11061584|NCT01364740|FG000|Participant Flow|SmartWatch PMP-300E|"Investigational device Smart Watch PMP-300E to measure sleep-related breathing was tested against conventional gold-standard In-Lab Polysomnography (sleep studies)~Smart Watch PMP-300E: Data collected from a Level 3 portable monitoring device~In-lab Polysomnography: Data collected from Type I In-Lab Polysomnography"
11061585|NCT01364740|OG000|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
11061586|NCT01364740|OG000|Outcome|PMP-300E|Patient questionnaire data collected after one night with the PMP-300E
11061587|NCT01364740|EG000|Reported Event|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
11061588|NCT01364870|BG000|Baseline|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
11066892|NCT01394003|OG000|Outcome|50 mg LY2584702 BID|Participants received 50 milligrams (mg) LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061589|NCT01364870|BG001|Baseline|Placebo TENS|"Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
11061590|NCT01364870|BG002|Baseline|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
11061591|NCT01364870|BG003|Baseline|Total|Total of all reporting groups
11061592|NCT01364870|FG000|Participant Flow|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
11061593|NCT01364870|FG001|Participant Flow|Placebo TENS|"Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
11061594|NCT01364870|FG002|Participant Flow|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
11061595|NCT01364870|OG000|Outcome|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
11061596|NCT01364870|OG001|Outcome|Placebo TENS|"Placebo TENS: Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
11061597|NCT01364870|OG002|Outcome|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
11061598|NCT01364870|EG000|Reported Event|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
11061599|NCT01364870|EG001|Reported Event|Placebo TENS|"Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
11061600|NCT01364870|EG002|Reported Event|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
11061601|NCT01364896|BG000|Baseline|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
11061602|NCT01364896|FG000|Participant Flow|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
11066893|NCT01394003|OG001|Outcome|75 mg LY2584702 BID|Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066894|NCT01394003|OG002|Outcome|100 mg LY2584702 BID|Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061603|NCT01364896|OG000|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
11061604|NCT01364896|EG000|Reported Event|Inflammatory Bowel Disease, Immunosuppressive Agent|Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
11061605|NCT01364922|BG000|Baseline|OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized)|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period; these participants were not randomized and did not progress to the double-blind period.
11061606|NCT01364922|BG001|Baseline|DB Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
11061607|NCT01364922|BG002|Baseline|DB Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
11061608|NCT01364922|BG003|Baseline|Total|Total of all reporting groups
11061609|NCT01364922|FG000|Participant Flow|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks.
11061610|NCT01364922|FG001|Participant Flow|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
11061611|NCT01364922|FG002|Participant Flow|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
11061612|NCT01364922|OG000|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
11061613|NCT01364922|OG001|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
11061614|NCT01364922|EG000|Reported Event|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period.
11061615|NCT01364922|EG001|Reported Event|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
11061616|NCT01364922|EG002|Reported Event|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
11061617|NCT01365039|BG000|Baseline|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11061618|NCT01365039|BG001|Baseline|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11061619|NCT01365039|BG002|Baseline|Total|Total of all reporting groups
11061620|NCT01365039|FG000|Participant Flow|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11061621|NCT01365039|FG001|Participant Flow|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11061622|NCT01365039|OG000|Outcome|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11061623|NCT01365039|OG001|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11061624|NCT01365039|OG000|Outcome|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11066895|NCT01394003|OG003|Outcome|300 mg LY2584702 BID|Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061625|NCT01365039|EG000|Reported Event|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11061626|NCT01365039|EG001|Reported Event|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
11061627|NCT01365052|BG000|Baseline|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
11061628|NCT01365052|BG001|Baseline|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
11061629|NCT01365052|BG002|Baseline|Total|Total of all reporting groups
11061630|NCT01365052|FG000|Participant Flow|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
11061631|NCT01365052|FG001|Participant Flow|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
11061632|NCT01365052|OG000|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
11061633|NCT01365052|OG001|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
11061634|NCT01365052|EG000|Reported Event|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
11061635|NCT01365052|EG001|Reported Event|Placebo|2 over-encapsulated tablets of placebo are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
11061636|NCT01365091|BG000|Baseline|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
11061637|NCT01365091|BG001|Baseline|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
11061638|NCT01365091|BG002|Baseline|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
11061639|NCT01365091|BG003|Baseline|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
11061640|NCT01365091|BG004|Baseline|Total|Total of all reporting groups
11061641|NCT01365091|FG000|Participant Flow|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
11066896|NCT01394003|EG000|Reported Event|25 mg LY2584702 QD|Participants received 25 milligrams (mg) of LY2584702 orally as a capsule, once daily (QD) for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066897|NCT01394003|EG001|Reported Event|50 mg LY2584702 QD|Participants received 50 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061642|NCT01365091|FG001|Participant Flow|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
11061643|NCT01365091|FG002|Participant Flow|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
11061644|NCT01365091|FG003|Participant Flow|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
11061645|NCT01365091|OG000|Outcome|Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
11061646|NCT01365091|OG001|Outcome|Sax, 5 mg/Met 500 mg vs FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
11061647|NCT01365091|OG002|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
11061648|NCT01365091|OG003|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
11061649|NCT01365091|OG000|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
11061650|NCT01365091|OG001|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met 500 mg FDC Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
11061651|NCT01365091|OG002|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fasting|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
11061652|NCT01365091|OG003|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
11061653|NCT01365091|OG000|Outcome|Arm 1: Treatments A,B/B,A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
11061654|NCT01365091|OG001|Outcome|Arm 2: Treatments C,D/D,C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
11061655|NCT01365091|OG002|Outcome|Arm 3: Treatments E,F/ F,E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
11061656|NCT01365091|OG003|Outcome|Arm 4: Treatments G,H/H,G|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
11061657|NCT01365091|OG000|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
11061658|NCT01365091|OG001|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
11061659|NCT01365091|EG000|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fasting|XR=extended release
11061660|NCT01365091|EG001|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fed|XR=extended release
11061661|NCT01365091|EG002|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fasting|XR=extended release
11061662|NCT01365091|EG003|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fed|XR=extended release
11061663|NCT01365091|EG004|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fasting|FDC=fixed-dose combination
11061664|NCT01365091|EG005|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fed|FDC=fixed-dose combination
11061665|NCT01365091|EG006|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fasting|FDC=fixed-dose combination
11061666|NCT01365091|EG007|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fed|FDC=fixed-dose combination
11061667|NCT01365130|BG000|Baseline|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
11061668|NCT01365130|FG000|Participant Flow|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
11061669|NCT01365130|OG000|Outcome|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
11061670|NCT01365130|EG000|Reported Event|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
11226744|NCT02377752|FG001|Participant Flow|Part A Cohort 2: Olaratumab+Doxorubicin|15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11226745|NCT02377752|FG002|Participant Flow|Part A Cohort 3 Olaratumab + Doxorubicin|20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11226746|NCT02377752|FG003|Participant Flow|Part B: Olaratumab|15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11226747|NCT02377752|OG000|Outcome|Part A Cohort 1: Olaratumab+Doxorubicin|15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11061671|NCT01365273|BG000|Baseline|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
11061672|NCT01365273|BG001|Baseline|Mepitel One|Device
11061673|NCT01365273|BG002|Baseline|Total|Total of all reporting groups
11061674|NCT01365273|FG000|Participant Flow|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
11226748|NCT02377752|OG001|Outcome|Part A Cohort 2: Olaratumab+Doxorubicin|15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11226749|NCT02377752|OG002|Outcome|Part A Cohort 3 Olaratumab + Doxorubicin|20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10887353|NCT00499915|EG001|Reported Event|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
11061675|NCT01365273|FG001|Participant Flow|Mepitel One|Device
11061676|NCT01365273|OG000|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
11061677|NCT01365273|OG001|Outcome|Mepitel One|Device
11061678|NCT01365273|EG000|Reported Event|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
11061679|NCT01365273|EG001|Reported Event|Mepitel One|Device
11061680|NCT01365455|BG000|Baseline|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
11061681|NCT01365455|BG001|Baseline|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
11061682|NCT01365455|BG002|Baseline|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
11061683|NCT01365455|BG003|Baseline|Total|Total of all reporting groups
11061684|NCT01365455|FG000|Participant Flow|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
11061685|NCT01365455|FG001|Participant Flow|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
11066898|NCT01394003|EG002|Reported Event|100 mg LY2584702 QD|Participants received 100 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061686|NCT01365455|FG002|Participant Flow|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
11061687|NCT01365455|FG003|Participant Flow|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
11061688|NCT01365455|FG004|Participant Flow|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
11061689|NCT01365455|OG000|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
11061690|NCT01365455|OG001|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
11061691|NCT01365455|OG002|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
11061692|NCT01365455|OG003|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
11061693|NCT01365455|OG004|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
11061694|NCT01365455|EG000|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
11061695|NCT01365455|EG001|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
11061696|NCT01365455|EG002|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
11061697|NCT01365455|EG003|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
11061698|NCT01365455|EG004|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
11061699|NCT01365455|EG005|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
11061700|NCT01365455|EG006|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
11061701|NCT01365455|EG007|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
11061702|NCT01365455|EG008|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
11061703|NCT01365455|EG009|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
11061704|NCT01365455|EG010|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
11061705|NCT01365468|BG000|Baseline|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11061706|NCT01365468|BG001|Baseline|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11061707|NCT01365468|BG002|Baseline|Total|Total of all reporting groups
11061708|NCT01365468|FG000|Participant Flow|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11061709|NCT01365468|FG001|Participant Flow|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11061710|NCT01365468|OG000|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11061711|NCT01365468|OG000|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11066899|NCT01394003|EG003|Reported Event|200 mg LY2584702 QD|Participants received 200 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061712|NCT01365468|OG001|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11061713|NCT01365468|EG000|Reported Event|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11061714|NCT01365468|EG001|Reported Event|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
11061715|NCT01365481|BG000|Baseline|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
11061716|NCT01365481|BG001|Baseline|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
11061717|NCT01365481|BG002|Baseline|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
11061718|NCT01365481|BG003|Baseline|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
11061719|NCT01365481|BG004|Baseline|Total|Total of all reporting groups
11061720|NCT01365481|FG000|Participant Flow|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
11061721|NCT01365481|FG001|Participant Flow|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
11061722|NCT01365481|FG002|Participant Flow|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
11061723|NCT01365481|FG003|Participant Flow|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
11066900|NCT01394003|EG004|Reported Event|50 mg LY2584702 BID|Participants received 50 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11226750|NCT02377752|OG000|Outcome|Part B: Olaratumab|15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11226751|NCT02377752|OG000|Outcome|Part A Cohort 2: Olaratumab+Doxorubicin|15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11061724|NCT01365481|OG000|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
11061725|NCT01365481|OG001|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
11061726|NCT01365481|EG000|Reported Event|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
11061727|NCT01365481|EG001|Reported Event|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
11061728|NCT01365481|EG002|Reported Event|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
11061729|NCT01365481|EG003|Reported Event|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
11061730|NCT01365481|EG004|Reported Event|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
11061731|NCT01365481|EG005|Reported Event|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
11061732|NCT01365494|BG000|Baseline|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedules."
11061733|NCT01365494|BG001|Baseline|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedules."
11061734|NCT01365494|BG002|Baseline|Total|Total of all reporting groups
11061735|NCT01365494|FG000|Participant Flow|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to either Zagreb schedule."
11061736|NCT01365494|FG001|Participant Flow|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
11061737|NCT01365494|OG000|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
11061738|NCT01365494|OG001|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
11061739|NCT01365494|OG000|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb schedule) (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
11061740|NCT01365494|EG000|Reported Event|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
11061741|NCT01365494|EG001|Reported Event|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
11061742|NCT01365507|BG000|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
11061743|NCT01365507|BG001|Baseline|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
11061744|NCT01365507|BG002|Baseline|Total|Total of all reporting groups
11061745|NCT01365507|FG000|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
11061746|NCT01365507|FG001|Participant Flow|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
11061747|NCT01365507|OG000|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
11061748|NCT01365507|OG001|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
11061749|NCT01365507|EG000|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
11061750|NCT01365507|EG001|Reported Event|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
11061751|NCT01365546|BG000|Baseline|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
11061752|NCT01365546|FG000|Participant Flow|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
11061753|NCT01365546|OG000|Outcome|Minor Surgery|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
11061754|NCT01365546|OG001|Outcome|Major Surgery|
11061755|NCT01365546|OG002|Outcome|All Surgeries|
11061756|NCT01365546|OG000|Outcome|Intra-operative Assessment by IDMC|
11061757|NCT01365546|OG000|Outcome|Post-operative Assessment by IDMC|
10887354|NCT00500110|BG000|Baseline|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
11061758|NCT01365546|EG000|Reported Event|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
11061759|NCT01365585|BG000|Baseline|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
11061760|NCT01365585|FG000|Participant Flow|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
11061761|NCT01365585|OG000|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
11061762|NCT01365585|EG000|Reported Event|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
11061763|NCT01365611|BG000|Baseline|All Study Participants|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
11061764|NCT01365611|FG000|Participant Flow|All Study Participants|"A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.~Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6."
11061765|NCT01365611|OG000|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
11061766|NCT01365611|OG001|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
11061767|NCT01365611|EG000|Reported Event|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
11061768|NCT01365611|EG001|Reported Event|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
11061769|NCT01365624|BG000|Baseline|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
11061770|NCT01365624|BG001|Baseline|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
11061771|NCT01365624|BG002|Baseline|Total|Total of all reporting groups
11061772|NCT01365624|FG000|Participant Flow|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
11061773|NCT01365624|FG001|Participant Flow|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
11061774|NCT01365624|OG000|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
11061775|NCT01365624|OG001|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
11061776|NCT01365624|EG000|Reported Event|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
11061777|NCT01365624|EG001|Reported Event|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
11061778|NCT01365650|BG000|Baseline|All Study Participants|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
11061779|NCT01365650|FG000|Participant Flow|Symptomatic Allergic Rhinitis|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
11061780|NCT01365650|OG000|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
11061781|NCT01365650|OG001|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
11061782|NCT01365650|OG002|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
11061783|NCT01365650|EG000|Reported Event|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
11061784|NCT01365650|EG001|Reported Event|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
11061785|NCT01365650|EG002|Reported Event|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
11061786|NCT01365793|BG000|Baseline|Rapid Rehydration Using 0.45% Saline Replacement Fluid|This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
11061787|NCT01365793|BG001|Baseline|Rapid Rehydration Using 0.9% Saline Replacement Fluid|This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
11061788|NCT01365793|BG002|Baseline|Slower Rehydration Using 0.45% Saline Replacement Fluid|This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
11061789|NCT01365793|BG003|Baseline|Slower Rehydration Using 0.9% Saline Replacement Fluid|This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
11061790|NCT01365793|BG004|Baseline|Total|Total of all reporting groups
11061791|NCT01365793|FG000|Participant Flow|Rapid Rehydration Using 0.45% Saline Replacement Fluid|This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
11061792|NCT01365793|FG001|Participant Flow|Rapid Rehydration Using 0.9% Saline Replacement Fluid|This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
11061793|NCT01365793|FG002|Participant Flow|Slower Rehydration Using 0.45% Saline Replacement Fluid|This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
11061794|NCT01365793|FG003|Participant Flow|Slower Rehydration Using 0.9% Saline Replacement Fluid|This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
11061795|NCT01365793|OG000|Outcome|Rapid Rehydration Using 0.45% Saline Replacement Fluid|This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
11061796|NCT01365793|OG001|Outcome|Rapid Rehydration Using 0.9% Saline Replacement Fluid|This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
11061797|NCT01365793|OG002|Outcome|Slower Rehydration Using 0.45% Saline Replacement Fluid|This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
11061798|NCT01365793|OG003|Outcome|Slower Rehydration Using 0.9% Saline Replacement Fluid|This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
11061799|NCT01365793|EG000|Reported Event|Rapid Rehydration Using 0.45% Saline Replacement Fluid|This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
11061800|NCT01365793|EG001|Reported Event|Rapid Rehydration Using 0.9% Saline Replacement Fluid|This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
11061801|NCT01365793|EG002|Reported Event|Slower Rehydration Using 0.45% Saline Replacement Fluid|This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
11061802|NCT01365793|EG003|Reported Event|Slower Rehydration Using 0.9% Saline Replacement Fluid|This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
11061803|NCT01365819|BG000|Baseline|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
11061804|NCT01365819|BG001|Baseline|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
11061805|NCT01365819|BG002|Baseline|Total|Total of all reporting groups
11061806|NCT01365819|FG000|Participant Flow|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
11061807|NCT01365819|FG001|Participant Flow|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
11061808|NCT01365819|OG000|Outcome|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
11061809|NCT01365819|OG001|Outcome|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
11066901|NCT01394003|EG005|Reported Event|75 mg LY2584702 BID|Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061810|NCT01365819|EG000|Reported Event|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
11061811|NCT01365819|EG001|Reported Event|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
11061812|NCT01365845|BG000|Baseline|Breast Patients Planned With Both Proton & Conventional Plans|"Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment.~Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
11061813|NCT01365845|FG000|Participant Flow|Induction Phase|During this phase, each patient will have both a proton and conventional radiation plan performed. The superior plan in regard to minimizing dose to heart will be the plan actually chosen for treating the patient.
11061814|NCT01365845|FG001|Participant Flow|Conventional Photon Plan|"Conventional (photon): 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
11061815|NCT01365845|FG002|Participant Flow|3D-Proton/Conventional Plan or 3D-proton Only|"3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy~This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
11061816|NCT01365845|OG000|Outcome|Conventional Photon Plan|Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
11061817|NCT01365845|OG001|Outcome|3D-Proton/Conventional Plan or 3D-proton Only|3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy per fraction
11061818|NCT01365845|EG000|Reported Event|Breast Patients Planned With Both Proton & Conventional Plans|"All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional.~Each patient was planned with both proton and conventional plans and the superior plan was chosen for treatment.~Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
11061819|NCT01365910|BG000|Baseline|Treatment (Enzyme Inhibitor)|Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11061820|NCT01365910|FG000|Participant Flow|Treatment (Enzyme Inhibitor)|ABT-869/Linifanib will be administered orally on a daily basis at 17.5 mg/day (fixed dose). The drug is provided in tablets of 2.5 mg or 10 mg tablets.This course of treatment repeats every 28 days until disease progression, intolerability, investigator decision or patient withdrawal of consent.
11061821|NCT01365910|OG000|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
11061822|NCT01365910|EG000|Reported Event|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
11061823|NCT01366196|BG000|Baseline|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
11061824|NCT01366196|BG001|Baseline|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
11061825|NCT01366196|BG002|Baseline|Total|Total of all reporting groups
11061826|NCT01366196|FG000|Participant Flow|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
11061827|NCT01366196|FG001|Participant Flow|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
11061828|NCT01366196|OG000|Outcome|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
11061829|NCT01366196|OG001|Outcome|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
11061830|NCT01366196|EG000|Reported Event|Control Group (C)|"Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.~Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.~All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.~On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.~Placebo: Patients will first receive two capsules of the placebo drug (with no active ingredients per dose) one hour before surgery. Patients will continue taking two capsules per day until POD 14."
11066902|NCT01394003|EG006|Reported Event|100 mg LY2584702 BID|Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11066903|NCT01394003|EG007|Reported Event|300 mg LY2584702 BID|Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
11061831|NCT01366196|EG001|Reported Event|Pregabalin Group (P)|"Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.~Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.~All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.~On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.~Pregabalin 150 mg: Patients will receive two 75 mg capsules of pregabalin 1 hour before surgery. They continue to take 2 capsules of 75 mg (total 150 mg) until POD 14."
11061832|NCT01366209|BG000|Baseline|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
11061833|NCT01366209|BG001|Baseline|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
11061834|NCT01366209|BG002|Baseline|Total|Total of all reporting groups
11061835|NCT01366209|FG000|Participant Flow|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
11061836|NCT01366209|FG001|Participant Flow|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
11061837|NCT01366209|OG000|Outcome|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
11061838|NCT01366209|OG001|Outcome|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
11061839|NCT01366209|EG000|Reported Event|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
11061840|NCT01366209|EG001|Reported Event|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
11061841|NCT01366417|BG000|Baseline|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
11061842|NCT01366417|FG000|Participant Flow|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
11061843|NCT01366417|OG000|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
11061844|NCT01366417|OG001|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
11061845|NCT01366417|EG000|Reported Event|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
11061846|NCT01366443|BG000|Baseline|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
10887355|NCT00500110|FG000|Participant Flow|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
11061847|NCT01366443|FG000|Participant Flow|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
11061848|NCT01366443|OG000|Outcome|Pregnant Women (Clinical Assessment vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the standard clinical assessment for rupture of membranes. The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
11061849|NCT01366443|OG001|Outcome|Pregnant Women (ROM Plus vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
10887356|NCT00500110|OG000|Outcome|Treatment|
11061850|NCT01366443|EG000|Reported Event|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
11061851|NCT01366495|BG000|Baseline|Project Bridge|"Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.~Project Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization."
11061852|NCT01366495|BG001|Baseline|Treatment as Usual|Passive referral to HIV community treatment provider
11061853|NCT01366495|BG002|Baseline|On-site Testing|Rapid oral swab HIV testing on-site at a community supervision office.
11061854|NCT01366495|BG003|Baseline|Off-Site Testing|HIV testing at a community treatment clinic.
11061855|NCT01366495|BG004|Baseline|Total|Total of all reporting groups
11061856|NCT01366495|FG000|Participant Flow|Project Bridge|"Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.~Project Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization."
11061857|NCT01366495|FG001|Participant Flow|Treatment As Usual|Passive referral to HIV community treatment provider.
11061858|NCT01366495|FG002|Participant Flow|On-site Testing|HIV testing on-site at probation/parole office
11061859|NCT01366495|FG003|Participant Flow|Off-Site Testing|Off-site HIV testing at a community health center or HIV clinic.
11149512|NCT01871142|EG000|Reported Event|Placebo + Normoxia|"Participants receiving placebo in normoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
11226752|NCT02377752|OG001|Outcome|Part A Cohort 3 Olaratumab + Doxorubicin|20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11226753|NCT02377752|OG003|Outcome|Part B: Olaratumab|15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11226754|NCT02377752|EG000|Reported Event|Part A Cohort 1: Olaratumab+Doxorubicin|15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11226755|NCT02377752|EG001|Reported Event|Part A Cohort 2: Olaratumab+Doxorubicin|15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11226756|NCT02377752|EG002|Reported Event|Part A Cohort 3 Olaratumab + Doxorubicin|20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11226757|NCT02377752|EG003|Reported Event|Part B: Olaratumab|15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11061860|NCT01366495|OG000|Outcome|On-site Rapid HIV Testing|"On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.~Project Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization."
11061861|NCT01366495|OG001|Outcome|Off-site Referral for HIV Testing|Off-site referral for rapid HIV testing at a community health center or HIV testing clinic
11061862|NCT01366495|OG000|Outcome|Project Bridge|"Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.~Project Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization."
11061863|NCT01366495|OG001|Outcome|Treatment As Usual|Passive referral to HIV community treatment provider.
11061864|NCT01366495|EG000|Reported Event|Project Bridge|"Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.~Project Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization."
11061865|NCT01366495|EG001|Reported Event|Treatment As Usual|Passive referral to HIV community treatment provider.
11061866|NCT01366495|EG002|Reported Event|On-site Testing|HIV testing on-site at probation/parole office.
11061867|NCT01366495|EG003|Reported Event|Off-site Testing|HIV testing at a community health center or HIV clinic.
11226758|NCT02377817|BG000|Baseline|PrenaBelt on First Night, Sham PrenaBelt on Second Night|"These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night.~PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.~Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points."
11061868|NCT01366521|BG000|Baseline|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061869|NCT01366521|BG001|Baseline|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061870|NCT01366521|BG002|Baseline|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061871|NCT01366521|BG003|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061872|NCT01366521|BG004|Baseline|Total|Total of all reporting groups
11061873|NCT01366521|FG000|Participant Flow|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061874|NCT01366521|FG001|Participant Flow|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061875|NCT01366521|FG002|Participant Flow|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061876|NCT01366521|FG003|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061877|NCT01366521|OG000|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061878|NCT01366521|OG001|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061879|NCT01366521|OG002|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061880|NCT01366521|OG003|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061881|NCT01366521|OG003|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061882|NCT01366521|EG000|Reported Event|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061883|NCT01366521|EG001|Reported Event|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061884|NCT01366521|EG002|Reported Event|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061885|NCT01366521|EG003|Reported Event|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061886|NCT01366521|EG004|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
11061887|NCT01366534|BG000|Baseline|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
11061888|NCT01366534|BG001|Baseline|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
11061889|NCT01366534|BG002|Baseline|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
11061890|NCT01366534|BG003|Baseline|Total|Total of all reporting groups
11061891|NCT01366534|FG000|Participant Flow|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
11061892|NCT01366534|FG001|Participant Flow|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
11061893|NCT01366534|FG002|Participant Flow|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
11061894|NCT01366534|OG000|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
11061895|NCT01366534|OG001|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
11061896|NCT01366534|OG002|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
11061897|NCT01366534|EG000|Reported Event|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
11061898|NCT01366534|EG001|Reported Event|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
11061899|NCT01366534|EG002|Reported Event|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
11061900|NCT01366638|BG000|Baseline|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11061901|NCT01366638|BG001|Baseline|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11061902|NCT01366638|BG002|Baseline|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
11061903|NCT01366638|BG003|Baseline|Total|Total of all reporting groups
11061904|NCT01366638|FG000|Participant Flow|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11061905|NCT01366638|FG001|Participant Flow|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11061906|NCT01366638|FG002|Participant Flow|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
11061907|NCT01366638|OG000|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11061908|NCT01366638|OG001|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11061909|NCT01366638|OG002|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
11061910|NCT01366638|EG000|Reported Event|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11061911|NCT01366638|EG001|Reported Event|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
11061912|NCT01366638|EG002|Reported Event|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
11061913|NCT01366846|BG000|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
11061914|NCT01366846|BG001|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
11061915|NCT01366846|BG002|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
11061916|NCT01366846|BG003|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
11061917|NCT01366846|BG004|Baseline|Total|Total of all reporting groups
11061918|NCT01366846|FG000|Participant Flow|Negative Stratum - Continued Peanut Avoidance Group|Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial)
11061919|NCT01366846|FG001|Participant Flow|Negative Stratum - Peanut Avoidance After Consumption Group|Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
11061920|NCT01366846|FG002|Participant Flow|Positive Stratum - Continued Peanut Avoidance Group|Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
11061921|NCT01366846|FG003|Participant Flow|Positive Stratum - Peanut Avoidance After Peanut Consumption G|Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
11061922|NCT01366846|OG000|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
11061923|NCT01366846|OG001|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
11061924|NCT01366846|OG002|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
11061925|NCT01366846|OG003|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
11061926|NCT01366846|OG000|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
11061927|NCT01366846|OG001|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
11061928|NCT01366846|OG000|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
11061929|NCT01366846|EG000|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
11149513|NCT01871142|EG001|Reported Event|Placebo + Hypoxia|"Participants receiving placebo in Hypoxic conditions Randomized crossover assignment for each participant Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% Oxygen)"
11061930|NCT01366846|EG001|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
11061931|NCT01366846|EG002|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
11061932|NCT01366846|EG003|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
11061933|NCT01366872|BG000|Baseline|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
11061934|NCT01366872|FG000|Participant Flow|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
11061935|NCT01366872|OG000|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
11061936|NCT01366872|EG000|Reported Event|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
11061937|NCT01366885|BG000|Baseline|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
11061938|NCT01366885|FG000|Participant Flow|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
11061939|NCT01366885|OG000|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
11061940|NCT01366885|EG000|Reported Event|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
11061941|NCT01366976|BG000|Baseline|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
11061942|NCT01366976|BG001|Baseline|Placebo|Saline in equivalent volume as study drug
11061943|NCT01366976|BG002|Baseline|Total|Total of all reporting groups
11061944|NCT01366976|FG000|Participant Flow|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
11061945|NCT01366976|FG001|Participant Flow|Placebo|Saline in equivalent volume as study drug
11061946|NCT01366976|OG000|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
11061947|NCT01366976|OG001|Outcome|Placebo|Saline infusion
11061948|NCT01366976|EG000|Reported Event|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
11061949|NCT01366976|EG001|Reported Event|Placebo|Saline infusion
11061950|NCT01367080|BG000|Baseline|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
11061951|NCT01367080|BG001|Baseline|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
11061952|NCT01367080|BG002|Baseline|Total|Total of all reporting groups
11061953|NCT01367080|FG000|Participant Flow|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
11061954|NCT01367080|FG001|Participant Flow|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
11061955|NCT01367080|OG000|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg administration Group
11061956|NCT01367080|OG001|Outcome|Etravil 25mg Group|Amitryptiline hydrochloride 25mg administration Group
11061957|NCT01367080|OG000|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
11061958|NCT01367080|OG001|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
11061959|NCT01367080|EG000|Reported Event|Etravil 10mg Group|Amitryptyline hydrochloride 10mg administration Group
11061960|NCT01367080|EG001|Reported Event|Etravil 25mg Group|Amitryptyline hydrochloride 25mg administration Group
11061961|NCT01367119|BG000|Baseline|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
11061962|NCT01367119|BG001|Baseline|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
11061963|NCT01367119|BG002|Baseline|Total|Total of all reporting groups
11061964|NCT01367119|FG000|Participant Flow|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
11061965|NCT01367119|FG001|Participant Flow|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
11061966|NCT01367119|OG000|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
11061967|NCT01367119|OG001|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
11061968|NCT01367119|EG000|Reported Event|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
11061969|NCT01367119|EG001|Reported Event|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
11061970|NCT01367158|BG000|Baseline|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
11061971|NCT01367158|BG001|Baseline|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
11061972|NCT01367158|BG002|Baseline|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
11061973|NCT01367158|BG003|Baseline|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
11061974|NCT01367158|BG004|Baseline|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
11061975|NCT01367158|BG005|Baseline|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
11061976|NCT01367158|BG006|Baseline|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
11061977|NCT01367158|BG007|Baseline|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
11061978|NCT01367158|BG008|Baseline|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
11061979|NCT01367158|BG009|Baseline|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
11061980|NCT01367158|BG010|Baseline|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
11061981|NCT01367158|BG011|Baseline|Total|Total of all reporting groups
11061982|NCT01367158|FG000|Participant Flow|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
11061983|NCT01367158|FG001|Participant Flow|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
11061984|NCT01367158|FG002|Participant Flow|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
11061985|NCT01367158|FG003|Participant Flow|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
11061986|NCT01367158|FG004|Participant Flow|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
11061987|NCT01367158|FG005|Participant Flow|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
11061988|NCT01367158|FG006|Participant Flow|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
11061989|NCT01367158|FG007|Participant Flow|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
11061990|NCT01367158|FG008|Participant Flow|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
11061991|NCT01367158|FG009|Participant Flow|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
11061992|NCT01367158|FG010|Participant Flow|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
11061993|NCT01367158|OG000|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
11061994|NCT01367158|OG001|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
11061995|NCT01367158|OG002|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
11061996|NCT01367158|OG003|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
11061997|NCT01367158|OG004|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
11061998|NCT01367158|OG005|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
11061999|NCT01367158|OG000|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
11062000|NCT01367158|OG001|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
11062001|NCT01367158|OG002|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
11062002|NCT01367158|OG003|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
11062003|NCT01367158|OG004|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
11062004|NCT01367158|OG003|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study.
11062005|NCT01367158|OG001|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
11062006|NCT01367158|OG002|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
11062007|NCT01367158|OG003|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
11062008|NCT01367158|OG004|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
11062009|NCT01367158|OG005|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
11062010|NCT01367158|OG006|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
11062011|NCT01367158|OG007|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
11062012|NCT01367158|OG008|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
11062013|NCT01367158|OG009|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
11062014|NCT01367158|OG010|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
11062015|NCT01367158|EG000|Reported Event|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
11062016|NCT01367158|EG001|Reported Event|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
11062017|NCT01367158|EG002|Reported Event|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
11062018|NCT01367158|EG003|Reported Event|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
11062019|NCT01367158|EG004|Reported Event|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
11062020|NCT01367158|EG005|Reported Event|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
11062021|NCT01367158|EG006|Reported Event|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
11062022|NCT01367158|EG007|Reported Event|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
11062023|NCT01367158|EG008|Reported Event|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
11062024|NCT01367158|EG009|Reported Event|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
11062025|NCT01367158|EG010|Reported Event|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
11062026|NCT01367236|BG000|Baseline|Standard Boosted|"Treatment with:~tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily"
11062027|NCT01367236|BG001|Baseline|Maraviroc-intesified Boosted|"Treatment with:~abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily"
11062028|NCT01367236|BG002|Baseline|Total|Total of all reporting groups
11062029|NCT01367236|FG000|Participant Flow|Standard Boosted|"Treatment with:~tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily"
11062030|NCT01367236|FG001|Participant Flow|Maraviroc-intesified Boosted|"Treatment with:~abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily"
11062031|NCT01367236|OG000|Outcome|Standard Boosted|"Treatment with:~tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily"
11062032|NCT01367236|OG001|Outcome|Maraviroc-intesified Boosted|"Treatment with:~abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily"
11062033|NCT01367236|EG000|Reported Event|Standard Boosted|"Treatment with:~tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily"
11062034|NCT01367236|EG001|Reported Event|Maraviroc-intesified Boosted|"Treatment with:~abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily"
11062035|NCT01367249|BG000|Baseline|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
11062036|NCT01367249|BG001|Baseline|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
11062037|NCT01367249|BG002|Baseline|Total|Total of all reporting groups
11062038|NCT01367249|FG000|Participant Flow|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
11062039|NCT01367249|FG001|Participant Flow|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
11062040|NCT01367249|OG000|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
11062041|NCT01367249|OG001|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
11062042|NCT01367249|EG000|Reported Event|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
11062043|NCT01367249|EG001|Reported Event|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
11062044|NCT01367262|BG000|Baseline|[^14C]-LY2886721|Single 25-mg LY2886721 dose containing approximately 80 μCi of [^14C]-LY2886721, administered as an oral solution.
11062045|NCT01367262|FG000|Participant Flow|[^14C]-LY2886721|Single 25-milligram (mg) LY2886721 dose containing approximately 80 microCuries (μCi) of carbon-14-labeled LY2886721 ([^14C]-LY2886721), administered as an oral solution.
11062046|NCT01367262|OG000|Outcome|[^14C]-LY2886721|Single 25-mg LY2886721 dose containing approximately 80 μCi of [^14C]-LY2886721, administered as an oral solution.
11062047|NCT01367262|EG000|Reported Event|[^14C]-LY2886721|Single 25-mg LY2886721 dose containing approximately 80 μCi of [^14C]-LY2886721, administered as an oral solution.
11062048|NCT01367275|BG000|Baseline|Brivanib + Irinotecan|Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m^2 on Day 1. One cycle is 14 days.
11062049|NCT01367275|FG000|Participant Flow|Brivanib + Irinotecan|Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m^2 on Day 1. One cycle is 14 days.
11062050|NCT01367275|OG000|Outcome|Brivanib + Irinotecan|Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m^2 on Day 1. One cycle is 14 days.
11062051|NCT01367275|EG000|Reported Event|Brivanib + Irinotecan|Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m^2 on Day 1. One cycle is 14 days.
11062052|NCT01367444|BG000|Baseline|Cohort 1|Participants (aged >=18 years) with advanced SMD, and VA <=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
11062053|NCT01367444|BG001|Baseline|Cohort 2|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
11062054|NCT01367444|BG002|Baseline|Cohort 3|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye.
11062055|NCT01367444|BG003|Baseline|Cohort 4|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye.
11062056|NCT01367444|BG004|Baseline|Cohort 5|Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062057|NCT01367444|BG005|Baseline|Cohort 6|Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062058|NCT01367444|BG006|Baseline|Cohort 7|Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062059|NCT01367444|BG007|Baseline|Total|Total of all reporting groups
11062060|NCT01367444|FG000|Participant Flow|Cohort 1|Participants (aged greater than or equal to [>=] 18 years) with advanced SMD, and visual acuity (VA) less than or equal to (<=) 20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field electroretinography (ERG) responses, received SAR422459 at lowest target dose level 1.8*10^5 transducing units (TU)/study eye.
11062061|NCT01367444|FG001|Participant Flow|Cohort 2|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
11062062|NCT01367444|FG002|Participant Flow|Cohort 3|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye.
11062063|NCT01367444|FG003|Participant Flow|Cohort 4|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye.
11062064|NCT01367444|FG004|Participant Flow|Cohort 5|Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062065|NCT01367444|FG005|Participant Flow|Cohort 6|Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062066|NCT01367444|FG006|Participant Flow|Cohort 7|Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062067|NCT01367444|OG000|Outcome|Cohort 1|Participants (aged >=18 years) with advanced SMD, and VA <=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
11062068|NCT01367444|OG001|Outcome|Cohort 2|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
11062069|NCT01367444|OG002|Outcome|Cohort 3|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye.
11062070|NCT01367444|OG003|Outcome|Cohort 4|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye.
11062071|NCT01367444|OG004|Outcome|Cohort 5|Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062072|NCT01367444|OG005|Outcome|Cohort 6|Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062073|NCT01367444|OG006|Outcome|Cohort 7|Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062074|NCT01367444|EG000|Reported Event|Cohort 1|Participants (aged >=18 years) with advanced SMD, and VA <=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
11062075|NCT01367444|EG001|Reported Event|Cohort 2|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
11062076|NCT01367444|EG002|Reported Event|Cohort 3|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye.
11062077|NCT01367444|EG003|Reported Event|Cohort 4|Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye.
11062078|NCT01367444|EG004|Reported Event|Cohort 5|Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062079|NCT01367444|EG005|Reported Event|Cohort 6|Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062080|NCT01367444|EG006|Reported Event|Cohort 7|Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
11062081|NCT01367457|BG000|Baseline|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
11062082|NCT01367457|BG001|Baseline|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
11062083|NCT01367457|BG002|Baseline|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
11062084|NCT01367457|BG003|Baseline|Total|Total of all reporting groups
11062085|NCT01367457|FG000|Participant Flow|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
11062086|NCT01367457|FG001|Participant Flow|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
11062087|NCT01367457|FG002|Participant Flow|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
11062088|NCT01367457|OG000|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
11062089|NCT01367457|OG001|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
11062090|NCT01367457|OG002|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
11062091|NCT01367457|EG000|Reported Event|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
11062092|NCT01367457|EG001|Reported Event|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
11062093|NCT01367457|EG002|Reported Event|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
11062094|NCT01367665|BG000|Baseline|Vismodegib - Locally Advanced|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062095|NCT01367665|BG001|Baseline|Vismodegib - Metastatic|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062096|NCT01367665|BG002|Baseline|Total|Total of all reporting groups
11062097|NCT01367665|FG000|Participant Flow|Vismodegib - Locally Advanced|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062098|NCT01367665|FG001|Participant Flow|Vismodegib - Metastatic|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062099|NCT01367665|OG000|Outcome|Vismodegib - Locally Advanced|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062100|NCT01367665|OG001|Outcome|Vismodegib - Metastatic|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062101|NCT01367665|OG000|Outcome|Vismodegib - Metastatic|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062102|NCT01367665|EG000|Reported Event|Vismodegib - Locally Advanced|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062103|NCT01367665|EG001|Reported Event|Vismodegib - Metastatic|Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
11062104|NCT01367704|BG000|Baseline|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
11062105|NCT01367704|BG001|Baseline|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
11062106|NCT01367704|BG002|Baseline|Total|Total of all reporting groups
11062107|NCT01367704|FG000|Participant Flow|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
11149514|NCT01871142|EG002|Reported Event|1000 mg Aes-103 + Hypoxia|"Participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
11062108|NCT01367704|FG001|Participant Flow|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
11062109|NCT01367704|OG000|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
11062110|NCT01367704|OG001|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
11062111|NCT01367704|EG000|Reported Event|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
11062112|NCT01367704|EG001|Reported Event|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
11062113|NCT01367834|BG000|Baseline|Growth Hormone|"Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
11062114|NCT01367834|BG001|Baseline|Control|Subjects will receive no GH or placebo.
11062115|NCT01367834|BG002|Baseline|Total|Total of all reporting groups
11062116|NCT01367834|FG000|Participant Flow|Growth Hormone|"Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
11062117|NCT01367834|FG001|Participant Flow|Control|Subjects will receive no GH or placebo.
11062118|NCT01367834|OG000|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
11062119|NCT01367834|OG001|Outcome|Control|No intervention
11062120|NCT01367834|EG000|Reported Event|Growth Hormone|"Subjects in the somatotropin (growth hormone, GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
11062121|NCT01367834|EG001|Reported Event|Control|Subjects will receive no GH or placebo.
11062122|NCT01367847|BG000|Baseline|Helping the Noncompliant Child|Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
11062123|NCT01367847|BG001|Baseline|TE-HNC|Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice & child behavior, reminders re: practice & sessions.
11062124|NCT01367847|BG002|Baseline|Total|Total of all reporting groups
11062125|NCT01367847|FG000|Participant Flow|Helping the Noncompliant Child|Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
11062126|NCT01367847|FG001|Participant Flow|TE-HNC|Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice & child behavior, reminders re: practice & sessions.
11062127|NCT01367847|OG000|Outcome|Helping the Noncompliant Child|Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
11062128|NCT01367847|OG001|Outcome|TE-HNC|Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice & child behavior, reminders re: practice & sessions.
11062129|NCT01367847|OG000|Outcome|Helping the Noncompliant Child|Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPT) program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
11062130|NCT01367847|EG000|Reported Event|Helping the Noncompliant Child|"Helping the Noncompliant Child (McMahon & Forehand), a well-established behavioral parent training program for parents of 3 to 8 year old children with externalizing problems~Helping the Noncompliant Child (HNC): Well-established behavioral parent training program (McMahon & Forehand) for parents of 3 to 8 y.o. children with externalizing problems"
11062131|NCT01367847|EG001|Reported Event|TE-HNC|"Standard HNC Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice & child behavior, reminders re: practice & sessions.~Technology-Enhanced Helping the Noncompliant Child (TE-HNC): Standard HNC program plus technology-enhancements (see description under Arm)"
11062132|NCT01367860|BG000|Baseline|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
11062133|NCT01367860|BG001|Baseline|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
11062134|NCT01367860|BG002|Baseline|Total|Total of all reporting groups
11062135|NCT01367860|FG000|Participant Flow|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
11062136|NCT01367860|FG001|Participant Flow|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
11062137|NCT01367860|OG000|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
11062138|NCT01367860|OG001|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
11062139|NCT01367860|EG000|Reported Event|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
11062140|NCT01367860|EG001|Reported Event|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
11062141|NCT01367886|BG000|Baseline|Fesoterodine|Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks.
11062142|NCT01367886|FG000|Participant Flow|Fesoterodine|"Females with overactive bladder symptoms were given Fesoterodine 4 mg. daily for six weeks.~Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
11062143|NCT01367886|OG000|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
11062144|NCT01367886|OG000|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
11062145|NCT01367886|EG000|Reported Event|Fesoterodine|"Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.~Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
11062146|NCT01368042|BG000|Baseline|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
11062147|NCT01368042|FG000|Participant Flow|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
11062148|NCT01368042|OG000|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
11062149|NCT01368042|EG000|Reported Event|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible patients treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
11062150|NCT01368081|BG000|Baseline|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
11062151|NCT01368081|BG001|Baseline|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
11062152|NCT01368081|BG002|Baseline|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
10847112|NCT00281684|OG003|Outcome|Co-Codamol|Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
11062153|NCT01368081|BG003|Baseline|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
11062154|NCT01368081|BG004|Baseline|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
11062155|NCT01368081|BG005|Baseline|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
11062156|NCT01368081|BG006|Baseline|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
11062157|NCT01368081|BG007|Baseline|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
11062158|NCT01368081|BG008|Baseline|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
11062159|NCT01368081|BG009|Baseline|DPP-IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
11062160|NCT01368081|BG010|Baseline|DPP-IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
11062161|NCT01368081|BG011|Baseline|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
11062162|NCT01368081|BG012|Baseline|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
11062163|NCT01368081|BG013|Baseline|Total|Total of all reporting groups
11062164|NCT01368081|FG000|Participant Flow|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
11062165|NCT01368081|FG001|Participant Flow|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
11062166|NCT01368081|FG002|Participant Flow|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
11062167|NCT01368081|FG003|Participant Flow|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
11062168|NCT01368081|FG004|Participant Flow|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
11062169|NCT01368081|FG005|Participant Flow|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
11062170|NCT01368081|FG006|Participant Flow|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
11062171|NCT01368081|FG007|Participant Flow|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
11062172|NCT01368081|FG008|Participant Flow|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
11062173|NCT01368081|FG009|Participant Flow|DPP-IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor
11062174|NCT01368081|FG010|Participant Flow|DPP-IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor
11062175|NCT01368081|FG011|Participant Flow|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
11062176|NCT01368081|FG012|Participant Flow|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
11062177|NCT01368081|OG000|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
11062178|NCT01368081|OG001|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
11062179|NCT01368081|OG002|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
11062180|NCT01368081|OG003|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
11062181|NCT01368081|OG004|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
11062182|NCT01368081|OG005|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
11062183|NCT01368081|OG006|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
11062184|NCT01368081|OG007|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
11062185|NCT01368081|OG008|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
11062186|NCT01368081|OG009|Outcome|DPP-IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
11062187|NCT01368081|OG010|Outcome|DPP-IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
11062188|NCT01368081|OG011|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
11062189|NCT01368081|OG012|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
11062190|NCT01368081|EG000|Reported Event|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
11062191|NCT01368081|EG001|Reported Event|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
11062192|NCT01368081|EG002|Reported Event|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
11062193|NCT01368081|EG003|Reported Event|Biguanide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
11062194|NCT01368081|EG004|Reported Event|Biguanide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
11062195|NCT01368081|EG005|Reported Event|Thiazolidinedione: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
11062196|NCT01368081|EG006|Reported Event|Thiazolidinedione: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
11062197|NCT01368081|EG007|Reported Event|Alpha-GI: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
11062198|NCT01368081|EG008|Reported Event|Alpha-GI: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
11062199|NCT01368081|EG009|Reported Event|DPP-4 Inhibitor: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
11062200|NCT01368081|EG010|Reported Event|DPP-4 Inhibitor: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
11062201|NCT01368081|EG011|Reported Event|Glinide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
11062202|NCT01368081|EG012|Reported Event|Glinide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
11062203|NCT01368211|BG000|Baseline|Mirasol First, Then Reference|"This study arm will receive first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
11062204|NCT01368211|BG001|Baseline|Reference First, Then Mirasol|"This study arm will receive first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
11062205|NCT01368211|BG002|Baseline|Total|Total of all reporting groups
11062206|NCT01368211|FG000|Participant Flow|Mirasol First, Then Reference|"This study arm received first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
11062207|NCT01368211|FG001|Participant Flow|Reference First, Then Mirasol|"This study arm received first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
11062208|NCT01368211|OG000|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
11062209|NCT01368211|OG001|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
11062210|NCT01368211|EG000|Reported Event|Mirasol-treated Platelets|Patients that received a Mirasol treated 2-4-day-old platelet transfusion.
11062211|NCT01368211|EG001|Reported Event|Untreated Reference Platelets|Patients that received an untreated reference2-4-day-old platelet transfusion.
11062212|NCT01368263|BG000|Baseline|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
11062213|NCT01368263|BG001|Baseline|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
11062214|NCT01368263|BG002|Baseline|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
11062215|NCT01368263|BG003|Baseline|Total|Total of all reporting groups
11062216|NCT01368263|FG000|Participant Flow|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
11062217|NCT01368263|FG001|Participant Flow|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
11062218|NCT01368263|FG002|Participant Flow|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
11062219|NCT01368263|OG000|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
11062220|NCT01368263|OG001|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
11062221|NCT01368263|OG002|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
11062222|NCT01368263|EG000|Reported Event|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
11062223|NCT01368263|EG001|Reported Event|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
11062224|NCT01368263|EG002|Reported Event|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
11062225|NCT01368276|BG000|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
11062226|NCT01368276|BG001|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
11062227|NCT01368276|BG002|Baseline|Total|Total of all reporting groups
11062228|NCT01368276|FG000|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
11062229|NCT01368276|FG001|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
11062230|NCT01368276|OG000|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
11062231|NCT01368276|OG001|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
11062232|NCT01368276|EG000|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
11062233|NCT01368276|EG001|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
11062234|NCT01368406|BG000|Baseline|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
11062235|NCT01368406|BG001|Baseline|Treatment as Usual|treatment as usual received by the patients
11062236|NCT01368406|BG002|Baseline|Total|Total of all reporting groups
11062237|NCT01368406|FG000|Participant Flow|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
11062238|NCT01368406|FG001|Participant Flow|Treatment as Usual|treatment as usual received by the patients
11062239|NCT01368406|OG000|Outcome|Wellness Program|lifestyle intervention for 12 weeks
11062240|NCT01368406|OG001|Outcome|Treatment as Usual|treatment as usual received by the patients
11062241|NCT01368406|EG000|Reported Event|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
11062242|NCT01368406|EG001|Reported Event|Treatment as Usual|treatment as usual received by the patients
11062243|NCT01368432|BG000|Baseline|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
11062244|NCT01368432|BG001|Baseline|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
11062245|NCT01368432|BG002|Baseline|Total|Total of all reporting groups
11062246|NCT01368432|FG000|Participant Flow|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
11062247|NCT01368432|FG001|Participant Flow|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
11062248|NCT01368432|OG000|Outcome|Placebo Group Baseline|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
11062249|NCT01368432|OG001|Outcome|Treatment Group Baseline|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
11062250|NCT01368432|OG000|Outcome|Placebo Group MADRS 12 Weeks|This group consists of participants who received the placebo intervention and their level of depression as assessed by the MADRS scoring system.
11062251|NCT01368432|OG001|Outcome|Treatment Group MADRS 12 Weeks|This group consists of participants who received escitalopram and their level of depression as assessed by the MADRS scoring system.
11062252|NCT01368432|OG000|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their baseline global health.
11062253|NCT01368432|OG001|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram and represents their baseline global health
11062254|NCT01368432|OG000|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their global health score at 12 weeks
11062255|NCT01368432|OG001|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram and represents their global health at 12 weeks.
11062256|NCT01368432|OG000|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their anxiety score.
11062257|NCT01368432|OG001|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention and represents their anxiety score.
11062258|NCT01368432|OG000|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their anxiety score.
11062259|NCT01368432|OG001|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention and represents their anxiety score.
11062260|NCT01368432|OG000|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
11062261|NCT01368432|OG001|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
11062262|NCT01368432|OG000|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
11062263|NCT01368432|OG001|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
11062264|NCT01368432|EG000|Reported Event|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
11062265|NCT01368432|EG001|Reported Event|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week.
11062266|NCT01368536|BG000|Baseline|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
11062267|NCT01368536|BG001|Baseline|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
11062268|NCT01368536|BG002|Baseline|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
11062269|NCT01368536|BG003|Baseline|Total|Total of all reporting groups
11062270|NCT01368536|FG000|Participant Flow|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
11062271|NCT01368536|FG001|Participant Flow|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
11062272|NCT01368536|FG002|Participant Flow|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
11062273|NCT01368536|OG000|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
11062274|NCT01368536|OG001|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
11062275|NCT01368536|OG001|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
11062276|NCT01368536|OG002|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
11062277|NCT01368536|EG000|Reported Event|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
11062278|NCT01368536|EG001|Reported Event|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
11062279|NCT01368536|EG002|Reported Event|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
11062280|NCT01368562|BG000|Baseline|Methylnaltrexone|Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
11062281|NCT01368562|FG000|Participant Flow|Methylnaltrexone|Participants received single dose of methylnaltrexone (MNTX) 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC) initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
11062282|NCT01368562|OG000|Outcome|Methylnaltrexone|Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
11062283|NCT01368562|EG000|Reported Event|Methylnaltrexone|Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
11062284|NCT01368614|BG000|Baseline|All Study Participants|All study participants that signed the consent are included in the baseline characteristics to due the high screen failure rate and large number of participants that discontinued the study.
11062285|NCT01368614|FG000|Participant Flow|Screening Period|All study participants that were screened and signed consent.
11062286|NCT01368614|FG001|Participant Flow|AVAPS-AE|AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
11062287|NCT01368614|FG002|Participant Flow|Respironics OmniLab Advanced BiPAP S Mode|Non-Invasive Ventilation (NIV) therapy modality in the OmniLab Advanced BiPAP.
11062288|NCT01368614|FG003|Participant Flow|Respironics OmniLab Advanced CPAP Mode|Non-Invasive Ventilation (NIV) therapy modality in the Respironics OmniLab Advanced CPAP
11062289|NCT01368614|OG000|Outcome|AVAPS-AE|"AVAPS-AE Mode of ventilation~AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes."
11062290|NCT01368614|OG001|Outcome|Respironics OmniLab Advanced BiPAP S Mode|"OmniLab Advanced BiPAP S Mode of ventilation~Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality"
11062291|NCT01368614|OG002|Outcome|Respironics OmniLab Advanced CPAP Mode|"OmniLab Advanced CPAP Mode of ventilation~Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality"
10887282|NCT00499616|FG003|Participant Flow|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.~Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
11062292|NCT01368614|EG000|Reported Event|AVAPS-AE|"AVAPS-AE Mode of ventilation~AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes."
11062293|NCT01368614|EG001|Reported Event|Respironics OmniLab Advanced BiPAP S Mode|"OmniLab Advanced BiPAP S Mode of ventilation~Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality"
11062294|NCT01368614|EG002|Reported Event|Respironics OmniLab Advanced CPAP Mode|"OmniLab Advanced CPAP Mode of ventilation~Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality"
11062295|NCT01368653|BG000|Baseline|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
11062296|NCT01368653|BG001|Baseline|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
11062297|NCT01368653|BG002|Baseline|Total|Total of all reporting groups
11062298|NCT01368653|FG000|Participant Flow|Standard Treatment|"In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
11062299|NCT01368653|FG001|Participant Flow|Standard Treatment+Practice Quitting|"In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
11062300|NCT01368653|OG000|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
11066904|NCT01394081|BG000|Baseline|Enhanced Enrollment and Engagement (EEE)|The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
11062301|NCT01368653|OG001|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
11062302|NCT01368653|OG001|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
11062303|NCT01368653|OG002|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
11062304|NCT01368653|OG003|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
11062305|NCT01368653|OG000|Outcome|Standard Treatment|"In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
11062306|NCT01368653|OG001|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
11062307|NCT01368653|EG000|Reported Event|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
11062308|NCT01368653|EG001|Reported Event|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
11062309|NCT01368653|EG002|Reported Event|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
11062310|NCT01368653|EG003|Reported Event|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
11062311|NCT01368809|BG000|Baseline|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
11062312|NCT01368809|BG001|Baseline|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
11062313|NCT01368809|BG002|Baseline|Total|Total of all reporting groups
11062314|NCT01368809|FG000|Participant Flow|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
11062315|NCT01368809|FG001|Participant Flow|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
11062316|NCT01368809|OG000|Outcome|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
11062317|NCT01368809|OG001|Outcome|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
11062318|NCT01368809|OG000|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
11062319|NCT01368809|OG001|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
11062320|NCT01368809|EG000|Reported Event|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
11062321|NCT01368809|EG001|Reported Event|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
11066905|NCT01394081|BG001|Baseline|Administrative Outreach (AO)|The Administrative Outreach includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
11066906|NCT01394081|BG002|Baseline|Total|Total of all reporting groups
11066907|NCT01394081|FG000|Participant Flow|Enhanced Enrollment and Engagement (EEE)|The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment. This intervention was provided by a rural health outreach worker.
11066908|NCT01394081|FG001|Participant Flow|Administrative Outreach (AO)|The Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
11066909|NCT01394081|OG000|Outcome|Enhanced Enrollment and Engagement(EEE)|The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
11066910|NCT01394081|OG001|Outcome|Administrative Outreach (AO)|The Administrative Outreach includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
11066911|NCT01394081|OG000|Outcome|Enhanced Enrollment and Engagement (EEE)|The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
11066912|NCT01394081|OG001|Outcome|Administrative Outreach (AO)|Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
11066913|NCT01394081|EG000|Reported Event|Enhanced Enrollment and Engagement (EEE)|Enhanced Enrollment and Engagement (EEE) intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
10847113|NCT00281684|OG000|Outcome|SB705498 400 mg|Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
11066914|NCT01394081|EG001|Reported Event|Administrative Outreach (AO)|Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
11066915|NCT01394159|BG000|Baseline|ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
11066916|NCT01394159|BG001|Baseline|FNA Needle|FNA: Acquire tissue with FNA needle
11066917|NCT01394159|BG002|Baseline|Total|Total of all reporting groups
11066918|NCT01394159|FG000|Participant Flow|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
11066919|NCT01394159|FG001|Participant Flow|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
11066920|NCT01394159|OG000|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
11066921|NCT01394159|OG001|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
11066922|NCT01394159|EG000|Reported Event|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
11066923|NCT01394159|EG001|Reported Event|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
11066924|NCT01394185|BG000|Baseline|All Participants|Participants received dronabinol (PL, 120mg, 240mg/day) in a randomized within-subject crossover design
11066925|NCT01394185|FG000|Participant Flow|Placebo, 120mg, 240mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
11066926|NCT01394185|FG001|Participant Flow|120mg, 240mg, Placebo|Participants received dronabinol for 12 days in the above order in a within-subject crossover
11066927|NCT01394185|FG002|Participant Flow|240mg, 120mg, Placebo|Participants received dronabinol for 12 days in the above order in a within-subject crossover
11066928|NCT01394185|FG003|Participant Flow|120mg, Placebo, 240mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
11066929|NCT01394185|FG004|Participant Flow|240mg, Placebo, 120mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
11066930|NCT01394185|FG005|Participant Flow|Placebo, 240mg, 120mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
11066931|NCT01394185|OG000|Outcome|Placebo|Placebo maintenance period
11062322|NCT01368835|BG000|Baseline|Ulthera Treatment|Treatment to the lower face and submental region.
11062323|NCT01368835|FG000|Participant Flow|Ulthera Treatment|Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions.
11062324|NCT01368835|OG000|Outcome|Ulthera Treatment|Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
11062325|NCT01368835|OG000|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
11062326|NCT01368835|EG000|Reported Event|Ulthera Treatment|Treatment to the lower face and submental region.
11062327|NCT01368874|BG000|Baseline|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
11062328|NCT01368874|BG001|Baseline|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
11062329|NCT01368874|BG002|Baseline|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
11062330|NCT01368874|BG003|Baseline|Total|Total of all reporting groups
11062331|NCT01368874|FG000|Participant Flow|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
11062332|NCT01368874|FG001|Participant Flow|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
11062333|NCT01368874|FG002|Participant Flow|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
11062334|NCT01368874|OG000|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.
11062335|NCT01368874|OG001|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.
11062336|NCT01368874|OG002|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.
11062337|NCT01368874|OG003|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up
11062338|NCT01368874|OG004|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
11062339|NCT01368874|OG000|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 60- visit.
11062340|NCT01368874|OG001|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 60-day study visit.
11062341|NCT01368874|OG002|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 60-day study visit.
11062342|NCT01368874|OG003|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-five (25) participants completed the 60-day study visit.
11062343|NCT01368874|OG004|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Thirty (30) participants completed the 60-day study visit.
11062344|NCT01368874|OG000|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
11062345|NCT01368874|OG001|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
11062346|NCT01368874|OG002|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
11062347|NCT01368874|OG003|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four(24) participants completed the 90-day study visit.
11062348|NCT01368874|OG004|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
11062349|NCT01368874|OG000|Outcome|All Subjects Treated|A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.
11062350|NCT01368874|OG001|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region.
11062351|NCT01368874|OG002|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental,submandibular,and lower neck regions.
11062352|NCT01368874|OG003|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions.
11062353|NCT01368874|OG004|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular, and lower neck regions.
11062354|NCT01368874|OG000|Outcome|All Subjects Treated|Sixty-four 64) treated participants' assessment of pain was completed during the Ulthera® treatment.
11062355|NCT01368874|OG001|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
11062356|NCT01368874|OG002|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
11062357|NCT01368874|OG003|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
11062358|NCT01368874|OG000|Outcome|All Subjects Treated|Sixty(60) of 64 treated participants completed the 180-day study visit.
11062359|NCT01368874|OG001|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
11062360|NCT01368874|OG002|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the study visit.
11062361|NCT01368874|OG003|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
11062362|NCT01368874|OG004|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
11062363|NCT01368874|OG003|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 90-day study visit.
11062364|NCT01368874|OG000|Outcome|All Subjects Treated|Sixty (60) of 64 treated participants completed the 180-day study visit.
11062365|NCT01368874|OG002|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 180-day study visit.
11062366|NCT01368874|OG000|Outcome|All Subjects Treated|Treated subjects completing a 60 day post-treatment visit.
11062367|NCT01368874|OG000|Outcome|All Subjects Treated|Treated subjects completing a 90 day post-treatment visit.
11062368|NCT01368874|OG000|Outcome|All Subjects Treated|Treated subjects completing a 180 day post-treatment visit.
11062369|NCT01368874|OG001|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region.
11062370|NCT01368874|EG000|Reported Event|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
11062371|NCT01368874|EG001|Reported Event|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
11062372|NCT01368874|EG002|Reported Event|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
11062373|NCT01368874|EG003|Reported Event|Groups B/C|
11062374|NCT01368900|BG000|Baseline|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
11062375|NCT01368900|FG000|Participant Flow|Treated Subjects|"The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation.~Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds.~All study subjects received an Ulthera treatment to the upper face."
11062376|NCT01368900|OG000|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
11062377|NCT01368900|OG000|Outcome|Subjects Treated|All study subject received an Ulthera treatment to the upper face.
11062378|NCT01368900|OG000|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
11062379|NCT01368900|EG000|Reported Event|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
11062380|NCT01368965|BG000|Baseline|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
11062381|NCT01368965|FG000|Participant Flow|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
11062382|NCT01368965|OG000|Outcome|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
11062383|NCT01368965|OG000|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
11062384|NCT01368965|OG000|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52).
11062385|NCT01368965|EG000|Reported Event|Enrolled Subjects|Includes all subjects enrolled, including 52 treated subjects and 2 non-treated subjects who withdrew consent prior to treatment.
11062386|NCT01369030|BG000|Baseline|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
11062387|NCT01369030|FG000|Participant Flow|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
11062388|NCT01369030|OG000|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
11062389|NCT01369030|EG000|Reported Event|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
11062390|NCT01369069|BG000|Baseline|IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL|"The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.~IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target."
11062391|NCT01369069|BG001|Baseline|Sub Q Insulin to Keep Glucose Less Than 180 mg/dL|"This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL~Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL."
11062392|NCT01369069|BG002|Baseline|Total|Total of all reporting groups
11062393|NCT01369069|FG000|Participant Flow|IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL|"The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.~IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target."
11062394|NCT01369069|FG001|Participant Flow|Sub Q Insulin to Keep Glucose Less Than 180 mg/dL|"This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL~Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL."
11062395|NCT01369069|OG000|Outcome|IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL|"The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.~IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target."
11062396|NCT01369069|OG001|Outcome|Sub Q Insulin to Keep Glucose Less Than 180 mg/dL|"This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL~Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL."
11062397|NCT01369069|EG000|Reported Event|IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL|"The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.~IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target."
11062398|NCT01369069|EG001|Reported Event|Sub Q Insulin to Keep Glucose Less Than 180 mg/dL|"This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL~Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL."
11062399|NCT01369108|BG000|Baseline|All Participants|"Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable.~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
11062400|NCT01369108|FG000|Participant Flow|All Participants|"Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable.~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
11062401|NCT01369108|OG000|Outcome|Flowable Composite|"Flowable composite~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth"
11062402|NCT01369108|OG001|Outcome|Conventional Composite|"Highly filled conventional composite restorative~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
11062403|NCT01369108|EG000|Reported Event|All Participants|"Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable.~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
11062404|NCT01369225|BG000|Baseline|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
11062405|NCT01369225|BG001|Baseline|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
11062406|NCT01369225|BG002|Baseline|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
11062407|NCT01369225|BG003|Baseline|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
11062408|NCT01369225|BG004|Baseline|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
11062409|NCT01369225|BG005|Baseline|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
11062410|NCT01369225|BG006|Baseline|Total|Total of all reporting groups
11062411|NCT01369225|FG000|Participant Flow|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
11062412|NCT01369225|FG001|Participant Flow|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
11062413|NCT01369225|FG002|Participant Flow|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
11062414|NCT01369225|FG003|Participant Flow|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
11062415|NCT01369225|FG004|Participant Flow|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
11062416|NCT01369225|FG005|Participant Flow|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
11062417|NCT01369225|OG000|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
11066932|NCT01394185|OG001|Outcome|120mg Dronabinol|120mg/day (40mg tid) dronabinol maintenance period
11062418|NCT01369225|OG001|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
11062419|NCT01369225|OG002|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
11062420|NCT01369225|OG003|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
11062421|NCT01369225|OG004|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
11062422|NCT01369225|OG005|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
11062423|NCT01369225|EG000|Reported Event|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
11062424|NCT01369225|EG001|Reported Event|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
11062425|NCT01369225|EG002|Reported Event|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
11062426|NCT01369225|EG003|Reported Event|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
11062427|NCT01369225|EG004|Reported Event|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
11062428|NCT01369225|EG005|Reported Event|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
11062429|NCT01369329|BG000|Baseline|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
11062430|NCT01369329|BG001|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
11062431|NCT01369329|BG002|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
11062432|NCT01369329|BG003|Baseline|Total|Total of all reporting groups
11062433|NCT01369329|FG000|Participant Flow|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
11062434|NCT01369329|FG001|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
11062435|NCT01369329|FG002|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
10847114|NCT00281684|OG001|Outcome|SB705498 1000 mg|Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
11062436|NCT01369329|OG000|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
11062437|NCT01369329|OG001|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
11062438|NCT01369329|OG002|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
11062439|NCT01369329|EG000|Reported Event|Placebo|Participants received a single dose of Placebo Intravenous (IV) infusion at week 0.
11062440|NCT01369329|EG001|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received a single dose of ustekinumab 130 milligram (mg) IV at week 0.
11062441|NCT01369329|EG002|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
11062442|NCT01369342|BG000|Baseline|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
11062443|NCT01369342|BG001|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
11062444|NCT01369342|BG002|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
11062445|NCT01369342|BG003|Baseline|Total|Total of all reporting groups
11062446|NCT01369342|FG000|Participant Flow|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
11062447|NCT01369342|FG001|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
11066933|NCT01394185|OG002|Outcome|240mg Dronabinol|240mg/day (80mg tid) dronabinol maintenance period
11066934|NCT01394185|EG000|Reported Event|Placebo|Placebo dronabinol maintenance
11066935|NCT01394185|EG001|Reported Event|120mg Dronabinol|120mg (40mg tid) dronabinol maintenance
11062448|NCT01369342|FG002|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
11062449|NCT01369342|OG000|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
11062450|NCT01369342|OG001|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
11062451|NCT01369342|OG002|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
11062452|NCT01369342|EG000|Reported Event|Placebo IV|Participants received single dose of Placebo Intravenous (IV) infusion at week 0.
11062453|NCT01369342|EG001|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received single dose of ustekinumab 130 milligram (mg) IV at week 0.
11062454|NCT01369342|EG002|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received a single tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
11062455|NCT01369355|BG000|Baseline|Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
11062456|NCT01369355|BG001|Baseline|UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
11062457|NCT01369355|BG002|Baseline|UST-I-Rsp-UST-90 mg Q8W Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
11062458|NCT01369355|BG003|Baseline|Placebo (PBO)-I-Rsp - PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized.
11062459|NCT01369355|BG004|Baseline|PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
11062460|NCT01369355|BG005|Baseline|UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance|Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
11062461|NCT01369355|BG006|Baseline|Total|Total of all reporting groups
11062462|NCT01369355|FG000|Participant Flow|Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
11062463|NCT01369355|FG001|Participant Flow|UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
11062464|NCT01369355|FG002|Participant Flow|UST-I-Rsp-UST-90 mg Q8W Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
11062465|NCT01369355|FG003|Participant Flow|Placebo (PBO)-I-Rsp - PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized.
11062466|NCT01369355|FG004|Participant Flow|PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
11062467|NCT01369355|FG005|Participant Flow|UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance|Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
11062468|NCT01369355|FG006|Participant Flow|Placebo Long Term Extension (LTE)|Participants who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272).
11062469|NCT01369355|FG007|Participant Flow|UST 90 mg SC Q12W LTE|Participants entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).
11062470|NCT01369355|FG008|Participant Flow|UST 90 mg SC Q8W LTE|Participants entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
11062471|NCT01369355|OG000|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
11062472|NCT01369355|OG001|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study.
11062473|NCT01369355|OG002|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
11062474|NCT01369355|EG000|Reported Event|Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study (includes events up to the time of loss of response).
11066936|NCT01394185|EG002|Reported Event|240mg Dronabinol|240mg (80mg tid) dronabinol maintenance
11066937|NCT01394250|BG000|Baseline|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
11062475|NCT01369355|EG001|Reported Event|UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received placebo SC and had dose adjustment to ustekinumab SC 90 mg q8w (includes events from the time of loss of response onward).
11062476|NCT01369355|EG002|Reported Event|UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 milligrams (mg) q12w in the maintenance study (includes events up to the time of loss of response).
11062477|NCT01369355|EG003|Reported Event|UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q12w and had dose adjustment to ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward).
11062478|NCT01369355|EG004|Reported Event|UST-I-Rsp-UST 90 mg SC Q8W Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q8w (includes events up to the time of loss of response).
11062479|NCT01369355|EG005|Reported Event|UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance|Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q8 weeks and remained on ustekinumab 90 mg q8w upon loss of response (includes events from the time of loss of response onward).
11062480|NCT01369355|EG006|Reported Event|Placebo (PBO)-I-Rsp PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC; not randomized.
11062481|NCT01369355|EG007|Reported Event|PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
11062482|NCT01369355|EG008|Reported Event|UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance|Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
11062483|NCT01369355|EG009|Reported Event|Placebo Long Term Extension (LTE)|Participants who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272).
11062484|NCT01369355|EG010|Reported Event|UST 90 mg SC Q12W LTE|Participants entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).
11062485|NCT01369355|EG011|Reported Event|UST 90 mg SC Q8W LTE|Participants entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
11062486|NCT01369433|BG000|Baseline|Monotherapy|Participants received oral tivozanib hydrochloride at the same dose and schedule as during the parent protocol. Studies under monotherapy were AV-951-10-112, AV-951-07-201, AV-951-110-202, AV-951-12-205, and AV-951-09-902. Drug: Tivozanib hydrochloride.
11062487|NCT01369433|BG001|Baseline|Combination Therapy|Participants who were receiving tivozanib hydrochloride combination, continued the combination therapy, as long as it was tolerated, at the same dose and schedule as in the parent protocol. Eligible participants who received sorafenib in Parent Study AV-951-09-902 at the time of study termination and who rolled into Study AV-951-09-901 began tivozanib hydrochloride at a dose of 1.5 mg/day. Studies under combination therapy were AV-951-07-102, AV-951-07-103, AV-951-08-104, AV-951-10-114, and AV-951-12-204. Combination Drugs: Tivozanib hydrochloride + temsirolimus, Tivozanib hydrochloride + paclitaxel, and Tivozanib hydrochloride + capecitabine.
11062488|NCT01369433|BG002|Baseline|Total|Total of all reporting groups
11062489|NCT01369433|FG000|Participant Flow|Monotherapy|Subjects received oral tivozanib hydrochloride at the same dose and schedule as during the parent protocol. Studies under monotherapy were AV-951-10-112, AV-951-07-201, AV-951-110-202, AV-951-12-205, and AV-951-09-902. Drug: Tivozanib hydrochloride.
11062490|NCT01369433|FG001|Participant Flow|Combination Therapy|Subjects who were receiving tivozanib hydrochloride combination, continued the combination therapy, as long as it was tolerated, at the same dose and schedule as in the parent protocol. Eligible subjects who received sorafenib in Parent Study AV-951-09-902 at the time of study termination and who rolled into Study AV-951-09-901 began tivozanib hydrochloride at a dose of 1.5 mg/day. Studies under combination therapy were AV-951-07-102, AV-951-07-103, AV-951-08-104, AV-951-10-114, and AV-951-12-204. Combination Drugs: Tivozanib hydrochloride + temsirolimus, Tivozanib hydrochloride + paclitaxel, and Tivozanib hydrochloride + capecitabine.
11062491|NCT01369433|OG000|Outcome|Monotherapy|Participants received oral tivozanib hydrochloride at the same dose and schedule as during the parent protocol. Studies under monotherapy were AV-951-10-112, AV-951-07-201, AV-951-110-202, AV-951-12-205, and AV-951-09-902. Drug: Tivozanib hydrochloride.
11062492|NCT01369433|OG001|Outcome|Combination Therapy|Participants who were receiving tivozanib hydrochloride combination, continued the combination therapy, as long as it was tolerated, at the same dose and schedule as in the parent protocol. Eligible participants who received sorafenib in Parent Study AV-951-09-902 at the time of study termination and who rolled into Study AV-951-09-901 began tivozanib hydrochloride at a dose of 1.5 mg/day. Studies under combination therapy were AV-951-07-102, AV-951-07-103, AV-951-08-104, AV-951-10-114, and AV-951-12-204. Combination Drugs: Tivozanib hydrochloride + temsirolimus, Tivozanib hydrochloride + paclitaxel, and Tivozanib hydrochloride + capecitabine.
11062493|NCT01369433|EG000|Reported Event|Monotherapy|Participants received oral tivozanib hydrochloride at the same dose and schedule as during the parent protocol. Studies under monotherapy were AV-951-10-112, AV-951-07-201, AV-951-110-202, AV-951-12-205, and AV-951-09-902. Drug: Tivozanib hydrochloride.
11066938|NCT01394250|BG001|Baseline|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
11066939|NCT01394250|BG002|Baseline|Total|Total of all reporting groups
10847115|NCT00281684|EG000|Reported Event|Placebo|Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
11066940|NCT01394250|FG000|Participant Flow|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
11066941|NCT01394250|FG001|Participant Flow|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
11062494|NCT01369433|EG001|Reported Event|Combination Therapy|Participants who were receiving tivozanib hydrochloride combination, continued the combination therapy, as long as it was tolerated, at the same dose and schedule as in the parent protocol. Eligible participants who received sorafenib in Parent Study AV-951-09-902 at the time of study termination and who rolled into Study AV-951-09-901 began tivozanib hydrochloride at a dose of 1.5 mg/day. Studies under combination therapy were AV-951-07-102, AV-951-07-103, AV-951-08-104, AV-951-10-114, and AV-951-12-204. Combination Drugs: Tivozanib hydrochloride + temsirolimus, Tivozanib hydrochloride + paclitaxel, and Tivozanib hydrochloride + capecitabine.
11062495|NCT01369485|BG000|Baseline|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
11062496|NCT01369485|BG001|Baseline|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
11062497|NCT01369485|BG002|Baseline|Total|Total of all reporting groups
11062498|NCT01369485|FG000|Participant Flow|Randomized Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.~Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
11062499|NCT01369485|FG001|Participant Flow|Randomized Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.~Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
11062500|NCT01369485|OG000|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
11062501|NCT01369485|OG001|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
11062502|NCT01369485|OG002|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
11062503|NCT01369485|OG003|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
11062504|NCT01369485|OG002|Outcome|Open Label Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
11062505|NCT01369485|OG003|Outcome|Open Label Sham Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
11062506|NCT01369485|OG002|Outcome|Open Label Active Treatment Group.|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
11062507|NCT01369485|OG003|Outcome|Open Label Sham Treatement Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
11062508|NCT01369485|EG000|Reported Event|Randomized Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
11062509|NCT01369485|EG001|Reported Event|Randomized Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
11062510|NCT01369485|EG002|Reported Event|Open Label Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
11062511|NCT01369485|EG003|Reported Event|Open Label Sham Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
11062512|NCT01369498|BG000|Baseline|Stage 1: SIM 200 mg|Participants were administered simtuzumab (SIM) 200 mg intravenous (IV) infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 94 weeks.
11062513|NCT01369498|BG001|Baseline|Stage 1: SIM 700 mg|Participants were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 40 weeks.
11062514|NCT01369498|BG002|Baseline|Stage 2: SIM 200 mg+Ruxolitinib|Participants on a stable dose of ruxolitinib were administered SIM 200 mg IV infusion over 30 minutes once every 2 weeks for up to 91 weeks.
11062515|NCT01369498|BG003|Baseline|Stage 2: SIM 700 mg+Ruxolitinib|Participants on a stable dose of ruxolitinib were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for up to 86 weeks.
11062516|NCT01369498|BG004|Baseline|Total|Total of all reporting groups
11062517|NCT01369498|FG000|Participant Flow|Stage 1: SIM 200 mg|Participants were administered simtuzumab (SIM) 200 mg intravenous (IV) infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 94 weeks.
11062518|NCT01369498|FG001|Participant Flow|Stage 1: SIM 700 mg|Participants were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 40 weeks.
11062519|NCT01369498|FG002|Participant Flow|Stage 2: SIM 200 mg+Ruxolitinib|Participants on a stable dose of ruxolitinib were administered SIM 200 mg IV infusion over 30 minutes once every 2 weeks for up to 91 weeks.
11062520|NCT01369498|FG003|Participant Flow|Stage 2: SIM 700 mg+Ruxolitinib|Participants on a stable dose of ruxolitinib were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for up to 86 weeks.
11062521|NCT01369498|OG000|Outcome|Stage 1: SIM 200 mg|Participants were administered simtuzumab (SIM) 200 mg intravenous (IV) infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 94 weeks.
11062522|NCT01369498|OG001|Outcome|Stage 1: SIM 700 mg|Participants were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 40 weeks.
11062523|NCT01369498|OG002|Outcome|Stage 2: SIM 200 mg+Ruxolitinib|Participants on a stable dose of ruxolitinib were administered SIM 200 mg IV infusion over 30 minutes once every 2 weeks for up to 91 weeks.
11062524|NCT01369498|OG003|Outcome|Stage 2: SIM 700 mg+Ruxolitinib|Participants on a stable dose of ruxolitinib were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for up to 86 weeks.
11062525|NCT01369498|OG000|Outcome|Stage 1: SIM 200 mg|Participants were administered SIM 200 mg IV infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 94 weeks.
11062526|NCT01369498|EG000|Reported Event|Stage 1: SIM 200 mg|Participants were administered simtuzumab (SIM) 200 mg intravenous (IV) infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 94 weeks.
11062527|NCT01369498|EG001|Reported Event|Stage 1: SIM 700 mg|Participants were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 40 weeks.
11062528|NCT01369498|EG002|Reported Event|Stage 2: SIM 200 mg+Ruxolitinib|Participants on a stable dose of ruxolitinib were administered SIM 200 mg IV infusion over 30 minutes once every 2 weeks for up to 91 weeks.
11062529|NCT01369498|EG003|Reported Event|Stage 2: SIM 700 mg+Ruxolitinib|Participants on a stable dose of ruxolitinib were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for up to 86 weeks.
11062530|NCT01369511|BG000|Baseline|Placebo|Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062531|NCT01369511|BG001|Baseline|35 mg LY2495655|LY2495655: 35 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
10847116|NCT00281684|EG001|Reported Event|SB705498 400 mg|Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
11062532|NCT01369511|BG002|Baseline|105 mg LY2495666|LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062533|NCT01369511|BG003|Baseline|315 mg LY2495655|LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062534|NCT01369511|BG004|Baseline|Total|Total of all reporting groups
11062535|NCT01369511|FG000|Participant Flow|Placebo|Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062536|NCT01369511|FG001|Participant Flow|35 mg LY2495655|LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062537|NCT01369511|FG002|Participant Flow|105 mg LY2495655|LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062538|NCT01369511|FG003|Participant Flow|315 mg LY2495655|LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062539|NCT01369511|OG000|Outcome|Placebo|Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062540|NCT01369511|OG001|Outcome|35 mg LY2495655|LY2495655: 35 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062541|NCT01369511|OG002|Outcome|105 mg LY2495655|LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062542|NCT01369511|OG003|Outcome|315 mg LY2495655|LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062543|NCT01369511|EG000|Reported Event|Placebo|Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062544|NCT01369511|EG001|Reported Event|35 mg LY2495655|LY2495655: 35 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062545|NCT01369511|EG002|Reported Event|105 mg LY2495655|LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062546|NCT01369511|EG003|Reported Event|315 mg LY2495655|LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
11062547|NCT01369615|BG000|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
11062548|NCT01369615|BG001|Baseline|≥ 12 to ≤ 16 Years|Children 12 to ≤ 16 years of age
11062549|NCT01369615|BG002|Baseline|Total|Total of all reporting groups
11062550|NCT01369615|FG000|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
11062551|NCT01369615|FG001|Participant Flow|≥ 12 to ≤ 16 Years|Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years.
11062552|NCT01369615|OG000|Outcome|6 to < 12 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
11062553|NCT01369615|OG001|Outcome|≥ 12 to ≤ 16 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
11062554|NCT01369615|EG000|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
11062555|NCT01369615|EG001|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
11062556|NCT01369680|BG000|Baseline|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
11062557|NCT01369680|BG001|Baseline|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
11062558|NCT01369680|BG002|Baseline|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
11062559|NCT01369680|BG003|Baseline|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
11062560|NCT01369680|BG004|Baseline|Total|Total of all reporting groups
11062561|NCT01369680|FG000|Participant Flow|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
11062562|NCT01369680|FG001|Participant Flow|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
11062563|NCT01369680|FG002|Participant Flow|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
11062564|NCT01369680|FG003|Participant Flow|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
11062565|NCT01369680|OG000|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine
11062566|NCT01369680|OG001|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine
11062567|NCT01369680|OG002|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine
11062568|NCT01369680|OG003|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine
11062569|NCT01369680|OG000|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
11062570|NCT01369680|OG001|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
11062571|NCT01369680|OG002|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
11062572|NCT01369680|OG003|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
11062573|NCT01369680|OG000|Outcome|Ketamine 0.25 mg/kg/Dose|Subjects treated at 0.25 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
11062574|NCT01369680|OG001|Outcome|Ketamine 0.5 mg/kg/Dose|Subjects treated at 0.5 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
11062575|NCT01369680|OG002|Outcome|Ketamine 1 mg/kg/Dose|Subjects treated at 1 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
11062576|NCT01369680|OG000|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
11062577|NCT01369680|OG001|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine.
11062578|NCT01369680|OG002|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
11062579|NCT01369680|OG003|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine.
11062580|NCT01369680|EG000|Reported Event|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
11062581|NCT01369680|EG001|Reported Event|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
11062582|NCT01369680|EG002|Reported Event|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
11062583|NCT01369680|EG003|Reported Event|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
11062584|NCT01369706|BG000|Baseline|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
11062585|NCT01369706|FG000|Participant Flow|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
11062586|NCT01369706|OG000|Outcome|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
11062587|NCT01369706|EG000|Reported Event|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
11062588|NCT01369732|BG000|Baseline|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
11062589|NCT01369732|BG001|Baseline|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
11062590|NCT01369732|BG002|Baseline|Total|Total of all reporting groups
11062591|NCT01369732|FG000|Participant Flow|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
11062592|NCT01369732|FG001|Participant Flow|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
11062593|NCT01369732|OG000|Outcome|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
11062594|NCT01369732|OG001|Outcome|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
11062595|NCT01369732|EG000|Reported Event|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
11062596|NCT01369732|EG001|Reported Event|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
11062597|NCT01369745|BG000|Baseline|Prednisolone|Prednisolone 2.7 mg once daily The trial would progress from Stage 1 to Stage 2 if the posterior probability that Z102 is superior to placebo was greater than 0.975.
11062598|NCT01369745|BG001|Baseline|Dipyridamole|dipyridamole 360 mg once daily The trial would progress from Stage 2 to Stage 3 if the posterior probability that Z102 is superior to dipyridamole was greater than 0.975.
11062599|NCT01369745|BG002|Baseline|Prednisone|Prednisone 5 mg once daily The trial would progress from Stage 2 to Stage 4 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
11062600|NCT01369745|BG003|Baseline|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily The trial would progress from Stage 3 to Stage 5 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
11062601|NCT01369745|BG004|Baseline|Placebo|placebo once daily
11062602|NCT01369745|BG005|Baseline|Total|Total of all reporting groups
11062603|NCT01369745|FG000|Participant Flow|Prednisolone|Prednisolone 2.7 mg once daily
11062604|NCT01369745|FG001|Participant Flow|Dipyridamole|dipyridamole 360 mg once daily
11062605|NCT01369745|FG002|Participant Flow|Prednisone|Prednisone 5 mg once daily
11062606|NCT01369745|FG003|Participant Flow|Z102|2.7 mg prednisolone plus 360 mg dipyridamole once daily
11062607|NCT01369745|FG004|Participant Flow|Placebo|placebo once daily
11062608|NCT01369745|OG000|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
11062609|NCT01369745|OG001|Outcome|Dipyridamole|dipyridamole 360 mg once daily
11062610|NCT01369745|OG002|Outcome|Prednisone|Prednisone 5 mg once daily
11062611|NCT01369745|OG003|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
11062612|NCT01369745|OG004|Outcome|Placebo|placebo once daily
11062613|NCT01369745|EG000|Reported Event|Prednisolone|Prednisolone 2.7 mg daily
11062614|NCT01369745|EG001|Reported Event|Dipyridamole|dipyridamole 360 mg once daily
11062615|NCT01369745|EG002|Reported Event|Prednisone|Prednisone 5 mg once daily
11062616|NCT01369745|EG003|Reported Event|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
11062617|NCT01369745|EG004|Reported Event|Placebo|placebo once daily
11062618|NCT01369758|BG000|Baseline|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
11062619|NCT01369758|FG000|Participant Flow|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
11062620|NCT01369758|OG000|Outcome|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
11062621|NCT01369758|EG000|Reported Event|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
11062622|NCT01369784|BG000|Baseline|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
11062623|NCT01369784|FG000|Participant Flow|Refractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma)|patients with refractory/relapsed diffuse large B-cell lymphoma
11062624|NCT01369784|OG000|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
11062625|NCT01369784|EG000|Reported Event|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
11062626|NCT01369849|BG000|Baseline|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062627|NCT01369849|BG001|Baseline|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062628|NCT01369849|BG002|Baseline|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062629|NCT01369849|BG003|Baseline|Total|Total of all reporting groups
11062630|NCT01369849|FG000|Participant Flow|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062631|NCT01369849|FG001|Participant Flow|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062632|NCT01369849|FG002|Participant Flow|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062633|NCT01369849|OG000|Outcome|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062634|NCT01369849|OG001|Outcome|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062635|NCT01369849|OG002|Outcome|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062636|NCT01369849|OG000|Outcome|Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062637|NCT01369849|OG000|Outcome|All Patients|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO (90 or 135 mg) on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062638|NCT01369849|EG000|Reported Event|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062639|NCT01369849|EG001|Reported Event|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062640|NCT01369849|EG002|Reported Event|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
11062641|NCT01369875|BG000|Baseline|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
11062642|NCT01369875|BG001|Baseline|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
11062643|NCT01369875|BG002|Baseline|Total|Total of all reporting groups
11062644|NCT01369875|FG000|Participant Flow|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
11062645|NCT01369875|FG001|Participant Flow|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
11062646|NCT01369875|OG000|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
11062647|NCT01369875|OG001|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
11062648|NCT01369875|EG000|Reported Event|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
11066942|NCT01394250|OG000|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
11062649|NCT01369875|EG001|Reported Event|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
11062650|NCT01369888|BG000|Baseline|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062651|NCT01369888|BG001|Baseline|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062652|NCT01369888|BG002|Baseline|IL-15 Following Young TIL (10.50 mcg)|"1 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062653|NCT01369888|BG003|Baseline|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062654|NCT01369888|BG004|Baseline|Total|Total of all reporting groups
11062655|NCT01369888|FG000|Participant Flow|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062656|NCT01369888|FG001|Participant Flow|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062657|NCT01369888|FG002|Participant Flow|IL-15 Following Young TIL (1 mcg)|"1 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062658|NCT01369888|FG003|Participant Flow|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062659|NCT01369888|OG000|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062660|NCT01369888|OG001|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062661|NCT01369888|EG000|Reported Event|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062662|NCT01369888|EG001|Reported Event|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
11062663|NCT01370005|BG000|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
11062664|NCT01370005|BG001|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
11062665|NCT01370005|BG002|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
11062666|NCT01370005|BG003|Baseline|Total|Total of all reporting groups
11062667|NCT01370005|FG000|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
11062668|NCT01370005|FG001|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
11062669|NCT01370005|FG002|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
11062670|NCT01370005|OG000|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
11062671|NCT01370005|OG001|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
11062672|NCT01370005|OG002|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
11062673|NCT01370005|EG000|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
11062674|NCT01370005|EG001|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
11062675|NCT01370005|EG002|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
11062676|NCT01370018|BG000|Baseline|Alpha-1-Proteinase Inhibitor in HIV|This pilot study was performed to examine the efficacy of alpha-1 proteinase inhibitor augmentation in 4 HIV-1 infected patients undergoing research treatment to elevate alpha-1-proteinase inhibitor and thereby, CD4 helper immune cells.Study subjects were evaluated at Baseline and weekly for at least 8 weeks.
11062677|NCT01370018|FG000|Participant Flow|Alpha-1-Proteinase Inhibitor/HIV|This pilot study was performed to examine the efficacy of alpha-1 proteinase inhibitor augmentation in HIV-1 infected patients undergoing research treatment to elevate alpha-1-proteinase inhibitor and thereby, CD4 helper immune cells.
11062678|NCT01370018|OG000|Outcome|Alpha-1-Proteinase Inhibitor in HIV|This pilot study was performed to show that Zemaira® treatment can be used in HIV-1 patients to elevate alpha-1-Proteinase Inhibitor and has the added benefit of elevating CD4 cells.
11062679|NCT01370018|EG000|Reported Event|Alpha-1-Proteinase Inhibitor|This pilot study was performed to show that Zemaira® treatment can be used in HIV-1 patients to elevate alpha-1-Proteinase Inhibitor and has the added benefit of elevating CD4 cells.
11062680|NCT01370083|BG000|Baseline|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
11062681|NCT01370083|BG001|Baseline|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
11062682|NCT01370083|BG002|Baseline|Total|Total of all reporting groups
11062683|NCT01370083|FG000|Participant Flow|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
11062684|NCT01370083|FG001|Participant Flow|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
11062685|NCT01370083|OG000|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
11062686|NCT01370083|OG001|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
11062687|NCT01370083|EG000|Reported Event|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
11062688|NCT01370083|EG001|Reported Event|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
11062689|NCT01370174|BG000|Baseline|Induced Step Training (IST)|"The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062690|NCT01370174|BG001|Baseline|Hip Strength Training (HST)|"The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062691|NCT01370174|BG002|Baseline|Combined Induced Step and Hip Strength Training|"This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062692|NCT01370174|BG003|Baseline|Standard Flexibility and Relaxation (SFR)|"The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062693|NCT01370174|BG004|Baseline|Total|Total of all reporting groups
11062694|NCT01370174|FG000|Participant Flow|Induced Step Training (IST)|"The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062695|NCT01370174|FG001|Participant Flow|Hip Strength Training (HST)|"The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062696|NCT01370174|FG002|Participant Flow|Combined Induced Step and Hip Strength Training|"This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062697|NCT01370174|FG003|Participant Flow|Standard Flexibility and Relaxation (SFR)|"The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062698|NCT01370174|OG000|Outcome|Induced Step Training (IST)|"The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062699|NCT01370174|OG001|Outcome|Hip Strength Training (HST)|"The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062700|NCT01370174|OG002|Outcome|Combined Induced Step and Hip Strength Training|"This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11066943|NCT01394250|OG001|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
11062701|NCT01370174|OG003|Outcome|Standard Flexibility and Relaxation (SFR)|"The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062702|NCT01370174|EG000|Reported Event|Induced Step Training (IST)|"The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062703|NCT01370174|EG001|Reported Event|Hip Strength Training (HST)|"The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062704|NCT01370174|EG002|Reported Event|Combined Induced Step and Hip Strength Training|"This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062705|NCT01370174|EG003|Reported Event|Standard Flexibility and Relaxation (SFR)|"The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.~Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises."
11062706|NCT01370213|BG000|Baseline|CD34+ Selection Schema : High-Risk Acute Myeloid Disease|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and filgrastim mobilized CD34+ selected peripheral blood stem cell graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx."
11062707|NCT01370213|BG001|Baseline|TCR α/β Depletion Schema : High-Risk Acute Myeloid Disease|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx."
11062708|NCT01370213|BG002|Baseline|TCR α/β Depletion and ATG at Different Time Schema|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered (3 mg/kg/day) pre-tx on different days per institutional guidelines"
11062709|NCT01370213|BG003|Baseline|Total|Total of all reporting groups
11066944|NCT01394250|EG000|Reported Event|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
11066945|NCT01394250|EG001|Reported Event|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
11149515|NCT01871142|EG003|Reported Event|Hypoxia 3000 mg Aes-103 + Hypoxia|"Participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen"
10847117|NCT00281684|EG002|Reported Event|SB705498 1000 mg|Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
11062710|NCT01370213|FG000|Participant Flow|CD34+ Selection Schema : High-Risk Acute Myeloid Disease|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and filgrastim mobilized CD34+ selected peripheral blood stem cell graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5 (3 mg/kg/day) pre-tx."
11062711|NCT01370213|FG001|Participant Flow|TCR α/β Depletion Schema : High-Risk Acute Myeloid Disease|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx."
11062712|NCT01370213|FG002|Participant Flow|TCR α/β Depletion and ATG at Different Time Schema|"PPatients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered (3 mg/kg/day) pre-tx on different days per institutional guidelines"
11062713|NCT01370213|OG000|Outcome|CD34+ Selection Schema : High-Risk Acute Myeloid Disease|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and filgrastim mobilized CD34+ selected peripheral blood stem cell graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx."
11062714|NCT01370213|OG001|Outcome|TCR α/β Depletion Schema : High-Risk Acute Myeloid Disease|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx."
11062715|NCT01370213|OG002|Outcome|TCR α/β Depletion and ATG at Different Time Schema|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor.~Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on different days per institutional guidelines"
11062716|NCT01370213|OG002|Outcome|TCR α/β Depletion and ATG at Different Time Schema|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and same donor TCR α/β-depleted cells infusion.~Preparative Regimen: Preparative Regimen:~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant, 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pretransplant, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pretransplant,~NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pretransplant.~Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion~Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on different days per institutional guidelines"
11149516|NCT01871285|BG000|Baseline|MSE Dose Group 1|Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
11062717|NCT01370213|EG000|Reported Event|High-Risk Acute Myeloid Disease|"Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and same donor TCR α/β-depleted cells infusion.~Data is reported in a combined manner because the AE data was originally reported in the older database as a single arm. Data was separated out for the outcome measures because there was still access to this data externally. At this point, we are unable to separate the individual instance of adverse events by arm because we cannot access the source data."
11062718|NCT01370265|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
11062719|NCT01370265|FG000|Participant Flow|Regadenoson, Then Adenosine|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
11062720|NCT01370265|FG001|Participant Flow|Adenosine, Then Regadenoson|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.
11062721|NCT01370265|OG000|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
11062722|NCT01370265|OG001|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
11062723|NCT01370265|OG000|Outcome|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
11062724|NCT01370265|EG000|Reported Event|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
11062725|NCT01370265|EG001|Reported Event|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
11062726|NCT01370317|BG000|Baseline|MK-1029|Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
11062727|NCT01370317|BG001|Baseline|Placebo|Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
10847118|NCT00281684|EG003|Reported Event|Co-Codamol|Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
10847119|NCT00281697|BG000|Baseline|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
10847120|NCT00281697|BG001|Baseline|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
10847121|NCT00281697|BG002|Baseline|Total|Total of all reporting groups
10847122|NCT00281697|FG000|Participant Flow|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
10847123|NCT00281697|FG001|Participant Flow|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
10847124|NCT00281697|OG000|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
10847125|NCT00281697|OG001|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
10847126|NCT00281697|EG000|Reported Event|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
10847127|NCT00281697|EG001|Reported Event|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
10847128|NCT00281827|BG000|Baseline|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
10847129|NCT00281827|FG000|Participant Flow|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
10847130|NCT00281827|OG000|Outcome|Evaluable Patients|Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
10847131|NCT00281827|OG000|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
10847132|NCT00281827|OG000|Outcome|Intent-To-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
10847133|NCT00281827|EG000|Reported Event|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
10849059|NCT00293462|BG000|Baseline|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
10887142|NCT00499083|BG000|Baseline|Vaccine|"Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.~Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.~Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion~All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections."
11062728|NCT01370317|BG002|Baseline|Total|Total of all reporting groups
11062729|NCT01370317|FG000|Participant Flow|MK-1029|Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
11062730|NCT01370317|FG001|Participant Flow|Placebo|Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
11062731|NCT01370317|OG000|Outcome|MK-1029|Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
11062732|NCT01370317|OG001|Outcome|Placebo|Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
11062733|NCT01370317|EG000|Reported Event|MK-1029|Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
11062734|NCT01370317|EG001|Reported Event|Placebo|Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
11062735|NCT01370356|BG000|Baseline|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. One participant was assigned to varenicline as a male but is in fact female. Data below are presented for the treated population.
11062736|NCT01370356|BG001|Baseline|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
11062737|NCT01370356|BG002|Baseline|Total|Total of all reporting groups
11062738|NCT01370356|FG000|Participant Flow|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg twice daily [BID]). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. Data below are presented for the treated population.
11062739|NCT01370356|FG001|Participant Flow|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
11062740|NCT01370356|OG000|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
11062741|NCT01370356|OG001|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
11062742|NCT01370356|EG000|Reported Event|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
11062743|NCT01370356|EG001|Reported Event|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
11062744|NCT01370369|BG000|Baseline|Testosterone Topical|"For single dose PKs, a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (2 strokes) of the testosterone gel 2% was applied to the shoulder/upper arm.~After the last 24 hour PK sampling from the shoulder/upper arm, 3 ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (1 stroke, 2 strokes and 3 strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments."
11062745|NCT01370369|FG000|Participant Flow|Testosterone Topical|"For single dose pharmacokinetics (PKs), a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the shoulder/upper arm.~After the last 24 hour PK sampling from the shoulder/upper arm, three ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (one stroke, two strokes and three strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments."
11062746|NCT01370369|OG000|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
11062747|NCT01370369|OG001|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
11062748|NCT01370369|OG002|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
11062749|NCT01370369|OG000|Outcome|Single Testosterone Dose (Inner Thigh)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a 7-day washout period.
11062750|NCT01370369|OG001|Outcome|Single Testosterone Dose (Abdomen)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a 7-day washout period.
11062751|NCT01370369|OG002|Outcome|Single Testosterone Dose (Shoulder/Upper Arm)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.
11062752|NCT01370369|OG001|Outcome|Single Testosterone Dose (Abdomen)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen thigh followed by a seven day washout period.
11062753|NCT01370369|OG000|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (One stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
11062754|NCT01370369|EG000|Reported Event|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (1 stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
11062755|NCT01370369|EG001|Reported Event|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (2 strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
11062756|NCT01370369|EG002|Reported Event|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (3 strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
11062757|NCT01370408|BG000|Baseline|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
11062758|NCT01370408|FG000|Participant Flow|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
11062759|NCT01370408|OG000|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
11062760|NCT01370408|EG000|Reported Event|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
11062761|NCT01370460|BG000|Baseline|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
11062762|NCT01370460|BG001|Baseline|Placebo|100mL 0.9% NS, applied topically
11062763|NCT01370460|BG002|Baseline|Total|Total of all reporting groups
11062764|NCT01370460|FG000|Participant Flow|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
11062765|NCT01370460|FG001|Participant Flow|Placebo|100mL 0.9% NS, applied topically
11062766|NCT01370460|OG000|Outcome|Placebo|100mL 0.9% NS, applied topically
11062767|NCT01370460|OG001|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
11062768|NCT01370460|OG000|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
11062769|NCT01370460|OG001|Outcome|Placebo|100mL 0.9% NS, applied topically
11062770|NCT01370460|EG000|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
11062771|NCT01370499|BG000|Baseline|LY2216684 + SSRI (Placebo Prior Study)|LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
11062772|NCT01370499|BG001|Baseline|LY2216684 + SSRI (LY2216684 Prior Study)|LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
11062773|NCT01370499|BG002|Baseline|Total|Total of all reporting groups
11062774|NCT01370499|FG000|Participant Flow|LY2216684 + SSRI (Placebo Prior Study)|LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
11062775|NCT01370499|FG001|Participant Flow|LY2216684 + SSRI (LY2216684 Prior Study)|LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
11062776|NCT01370499|OG000|Outcome|LY2216684 + SSRI (Placebo Prior Study)|LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
11062777|NCT01370499|OG001|Outcome|LY2216684 + SSRI (LY2216684 Prior Study)|LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
11062778|NCT01370499|EG000|Reported Event|LY2216684 + SSRI (Placebo Prior Study)|"LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all randomized participants who received at least 1 dose of study drug."
11062779|NCT01370499|EG001|Reported Event|LY2216684 + SSRI (LY2216684 Prior Study)|"LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all randomized participants who received at least 1 dose of study drug."
11062780|NCT01370499|EG002|Reported Event|LY2216684 + SSRI (Placebo Prior Study) DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who received at least 1 dose of study drug and abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11062781|NCT01370499|EG003|Reported Event|LY2216684 + SSRI (LY2216684 Prior Study) DC Phase|"No study drug was administered. Participants were to maintain their SSRI treatment at a stable dose for 1 week.~Includes all participants who received at least 1 dose of study drug and abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
11062782|NCT01370525|BG000|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
11062783|NCT01370525|BG001|Baseline|Placebo|Placebo for Esomeprazole
11062784|NCT01370525|BG002|Baseline|Total|Total of all reporting groups
11062785|NCT01370525|FG000|Participant Flow|Esomeprazole|Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate
11062786|NCT01370525|FG001|Participant Flow|Placebo|Placebo for Esomeprazole
11062787|NCT01370525|OG000|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
11062788|NCT01370525|OG001|Outcome|Placebo|Placebo for Esomeprazole
11062789|NCT01370525|EG000|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
11062790|NCT01370525|EG001|Reported Event|Placebo|Placebo for Esomeprazole
11062791|NCT01370538|BG000|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
11062792|NCT01370538|BG001|Baseline|Placebo|Placebo for Esomeprazole
11062793|NCT01370538|BG002|Baseline|Total|Total of all reporting groups
11062794|NCT01370538|FG000|Participant Flow|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
11062795|NCT01370538|FG001|Participant Flow|Placebo|Placebo for Esomeprazole
11062796|NCT01370538|OG000|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
11062797|NCT01370538|OG001|Outcome|Placebo|Placebo for Esomeprazole
11062798|NCT01370538|EG000|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
11062799|NCT01370538|EG001|Reported Event|Placebo|Placebo for Esomeprazole
11062800|NCT01370564|BG000|Baseline|Daily Diuretic Adjustment|"Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.~Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures."
11062801|NCT01370564|FG000|Participant Flow|Daily Diuretic Adjustment|"Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.~Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures."
11062802|NCT01370564|OG000|Outcome|Daily Diuretic Adjustment|"Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.~Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures."
11062803|NCT01370564|EG000|Reported Event|Daily Diuretic Adjustment|"Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.~Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures."
11062804|NCT01370616|BG000|Baseline|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
11062805|NCT01370616|BG001|Baseline|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
11062806|NCT01370616|BG002|Baseline|Total|Total of all reporting groups
11062807|NCT01370616|FG000|Participant Flow|Ertapenem Sodium|Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
11062808|NCT01370616|FG001|Participant Flow|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
11062809|NCT01370616|OG000|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
11062810|NCT01370616|OG001|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
11062811|NCT01370616|EG000|Reported Event|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
11062812|NCT01370616|EG001|Reported Event|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
11062813|NCT01370629|BG000|Baseline|All Participants|"Participants treated with vernakalant IV in acute care and inpatient hospital settings~Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice"
11062814|NCT01370629|FG000|Participant Flow|All Participants|"Participants treated with vernakalant IV in acute care and inpatient hospital settings~Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice"
11062815|NCT01370629|OG000|Outcome|All Participants|"Participants treated with vernakalant IV in acute care and inpatient hospital settings~Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice"
11062816|NCT01370629|EG000|Reported Event|All Participants|"Participants treated with vernakalant IV in acute care and inpatient hospital settings~Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice"
11062817|NCT01370642|BG000|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
11062818|NCT01370642|BG001|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
11062819|NCT01370642|BG002|Baseline|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
11062820|NCT01370642|BG003|Baseline|Total|Total of all reporting groups
11062821|NCT01370642|FG000|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
11062822|NCT01370642|FG001|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
11062823|NCT01370642|FG002|Participant Flow|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
11062824|NCT01370642|OG000|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
11062825|NCT01370642|OG001|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
11062826|NCT01370642|OG002|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
11062827|NCT01370642|EG000|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
11062828|NCT01370642|EG001|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
11062829|NCT01370642|EG002|Reported Event|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
11062830|NCT01370655|BG000|Baseline|Treatment A → Treatment C|Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
11062831|NCT01370655|BG001|Baseline|Treatment C → Treatment A|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
11062832|NCT01370655|BG002|Baseline|Treatment A → Treatment D|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
11062833|NCT01370655|BG003|Baseline|Treatment D → Treatment A|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
11062834|NCT01370655|BG004|Baseline|Treament D → Treatment C|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
11062835|NCT01370655|BG005|Baseline|Treatment C → Treatment D|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
11062836|NCT01370655|BG006|Baseline|Treatment A → Treatment B|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
11062837|NCT01370655|BG007|Baseline|Treatment B → Treatment A|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
11062838|NCT01370655|BG008|Baseline|Treatment B → Treatment C|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
11062839|NCT01370655|BG009|Baseline|Treatment C → Treatment B|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
11062840|NCT01370655|BG010|Baseline|Treatment B → Treatment D|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
11062841|NCT01370655|BG011|Baseline|Treatment D → Treament B|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
11062842|NCT01370655|BG012|Baseline|Total|Total of all reporting groups
11062843|NCT01370655|FG000|Participant Flow|Treatment A → Treatment C|Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
11062844|NCT01370655|FG001|Participant Flow|Treatment C → Treatment A|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
11062845|NCT01370655|FG002|Participant Flow|Treatment A → Treatment D|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
11062846|NCT01370655|FG003|Participant Flow|Treatment D → Treatment A|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
11062847|NCT01370655|FG004|Participant Flow|Treament D → Treatment C|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
11062848|NCT01370655|FG005|Participant Flow|Treatment C → Treatment D|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
11062849|NCT01370655|FG006|Participant Flow|Treatment A → Treatment B|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
11062850|NCT01370655|FG007|Participant Flow|Treatment B → Treatment A|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
11062851|NCT01370655|FG008|Participant Flow|Treatment B → Treatment C|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
11062852|NCT01370655|FG009|Participant Flow|Treatment C → Treatment B|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
11062853|NCT01370655|FG010|Participant Flow|Treatment B → Treatment D|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
11062854|NCT01370655|FG011|Participant Flow|Treatment D → Treament B|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
11062855|NCT01370655|OG000|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
11062856|NCT01370655|OG001|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
11062857|NCT01370655|OG002|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
11062858|NCT01370655|OG003|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
11062859|NCT01370655|EG000|Reported Event|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
11062860|NCT01370655|EG001|Reported Event|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
11062861|NCT01370655|EG002|Reported Event|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
11062862|NCT01370655|EG003|Reported Event|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
11062863|NCT01370694|BG000|Baseline|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
11062864|NCT01370694|FG000|Participant Flow|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
11062865|NCT01370694|OG000|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
11062866|NCT01370694|EG000|Reported Event|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
11062867|NCT01370733|BG000|Baseline|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
11062868|NCT01370733|BG001|Baseline|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
11062869|NCT01370733|BG002|Baseline|Total|Total of all reporting groups
11062870|NCT01370733|FG000|Participant Flow|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
11062871|NCT01370733|FG001|Participant Flow|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
11062872|NCT01370733|OG000|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
11062873|NCT01370733|OG001|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
11062874|NCT01370733|EG000|Reported Event|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
11062875|NCT01370733|EG001|Reported Event|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
11062876|NCT01370837|BG000|Baseline|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062877|NCT01370837|BG001|Baseline|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062878|NCT01370837|BG002|Baseline|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062879|NCT01370837|BG003|Baseline|Total|Total of all reporting groups
11062880|NCT01370837|FG000|Participant Flow|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062881|NCT01370837|FG001|Participant Flow|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062882|NCT01370837|FG002|Participant Flow|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062883|NCT01370837|OG000|Outcome|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062884|NCT01370837|OG001|Outcome|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062885|NCT01370837|OG002|Outcome|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062886|NCT01370837|EG000|Reported Event|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062887|NCT01370837|EG001|Reported Event|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
10849060|NCT00293462|BG001|Baseline|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
11062888|NCT01370837|EG002|Reported Event|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
11062889|NCT01370863|BG000|Baseline|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
11062890|NCT01370863|BG001|Baseline|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
11062891|NCT01370863|BG002|Baseline|Total|Total of all reporting groups
11062892|NCT01370863|FG000|Participant Flow|SPD557|0.5 mg tablet administered 3 times daily (t.i.d.) for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
11062893|NCT01370863|FG001|Participant Flow|Placebo|Matching placebo tablet administered three times daily (t.i.d.) for 4 weeks in addition to stable PPI treatment
11062894|NCT01370863|OG000|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
11062895|NCT01370863|OG001|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
11062896|NCT01370863|EG000|Reported Event|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
11062897|NCT01370863|EG001|Reported Event|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
11062898|NCT01371006|BG000|Baseline|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
11062899|NCT01371006|BG001|Baseline|Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
11062900|NCT01371006|BG002|Baseline|Total|Total of all reporting groups
11062901|NCT01371006|FG000|Participant Flow|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
11062902|NCT01371006|FG001|Participant Flow|Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
11062903|NCT01371006|OG000|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
11062904|NCT01371006|OG001|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
11062905|NCT01371006|OG000|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
11062906|NCT01371006|OG001|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
11062907|NCT01371006|OG000|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
11062908|NCT01371006|OG000|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
11062909|NCT01371006|OG000|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
11062910|NCT01371006|OG000|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
10849061|NCT00293462|BG002|Baseline|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
11062911|NCT01371006|OG001|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
11062912|NCT01371006|OG000|Outcome|Efavirenz|Treatment with single-dose Efavirenz.
11062913|NCT01371006|OG001|Outcome|Faldaprevir|During treatment with Faldaprevir.
11062914|NCT01371006|OG002|Outcome|Efavirenz+Faldaprevir|During treatment with Faldaprevir and single-dose Efavirenz.
11062915|NCT01371006|OG003|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
11062916|NCT01371006|OG000|Outcome|Midazolam|Treatment with single-dose Midazolam.
11062917|NCT01371006|OG002|Outcome|Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam.
11062918|NCT01371006|OG003|Outcome|Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam
11062919|NCT01371006|OG004|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
11062920|NCT01371006|EG000|Reported Event|Group A: Efavirenz|Treatment with single-dose Efavirenz in Group A.
11062921|NCT01371006|EG001|Reported Event|Group A: Faldaprevir|During treatment with Faldaprevir in Group A.
11062922|NCT01371006|EG002|Reported Event|Group A: Faldaprevir+Efavirenz|During treatment with Faldaprevir and single-dose Efavirenz in Group A.
11062923|NCT01371006|EG003|Reported Event|Group B: Midazolam|Treatment with single-dose Midazolam in Group B.
11062924|NCT01371006|EG004|Reported Event|Group B: Faldaprevir|During treatment with Faldaprevir in Group B.
11062925|NCT01371006|EG005|Reported Event|Group B: Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam in Group B.
11062926|NCT01371006|EG006|Reported Event|Group B: Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B.
11062927|NCT01371032|BG000|Baseline|Video-Miller Laryngoscope|"using the screen (Video laryngoscopy group)~VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)"
11062928|NCT01371032|BG001|Baseline|Direct Laryngoscopy|"without use the screen (Direct laryngoscopy group)~Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)"
11062929|NCT01371032|BG002|Baseline|Total|Total of all reporting groups
11062930|NCT01371032|FG000|Participant Flow|Video-Miller Laryngoscope|"using the screen (Video laryngoscopy group)~VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)"
11062931|NCT01371032|FG001|Participant Flow|Direct Laryngoscopy|"without use the screen (Direct laryngoscopy group)~Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)"
11062932|NCT01371032|OG000|Outcome|Video-Miller Laryngoscope|"using the screen (Video laryngoscopy group)~VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)"
11062933|NCT01371032|OG001|Outcome|Direct Laryngoscopy|"without use the screen (Direct laryngoscopy group)~Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)"
11062934|NCT01371032|OG000|Outcome|Video-Miller Laryngoscope|Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation)
11062935|NCT01371032|OG001|Outcome|Direct Laryngoscopy|Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen).
11062936|NCT01371032|EG000|Reported Event|Video-Miller Laryngoscope|Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation)
11062937|NCT01371032|EG001|Reported Event|Direct Laryngoscopy|Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen).
11062938|NCT01371110|BG000|Baseline|Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
11062939|NCT01371110|BG001|Baseline|Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
11062940|NCT01371110|BG002|Baseline|Total|Total of all reporting groups
11062941|NCT01371110|FG000|Participant Flow|Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
11062942|NCT01371110|FG001|Participant Flow|Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
11062943|NCT01371110|OG000|Outcome|Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
11062944|NCT01371110|OG001|Outcome|Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
11062945|NCT01371110|EG000|Reported Event|Ketamine|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
11062946|NCT01371110|EG001|Reported Event|Midazolam|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
11062947|NCT01371539|BG000|Baseline|Overall|All enrolled and dispensed participants
11062948|NCT01371539|FG000|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
11062949|NCT01371539|FG001|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
11062950|NCT01371539|OG000|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
11062951|NCT01371539|OG001|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
11062952|NCT01371539|EG000|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
11062953|NCT01371539|EG001|Reported Event|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
11062954|NCT01371552|BG000|Baseline|Overall Study|This reporting group includes all enrolled participants.
11062955|NCT01371552|FG000|Participant Flow|Delefilcon A / Filcon II 3 / Narafilcon A|Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
11062956|NCT01371552|FG001|Participant Flow|Narafilcon A / Filcon II 3 / Delefilcon A|Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
11062957|NCT01371552|FG002|Participant Flow|Filcon II 3 / Narafilcon A / Delefilcon A|Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
11062958|NCT01371552|FG003|Participant Flow|Delefilcon A / Narafilcon A / Filcon II 3|Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
11062959|NCT01371552|FG004|Participant Flow|Narafilcon A / Delefilcon A / Filcon II 3|Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
11062960|NCT01371552|FG005|Participant Flow|Filcon II 3 / Delefilcon A / Narafilcon A|Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
11062961|NCT01371552|OG000|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
11062962|NCT01371552|OG001|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
11062963|NCT01371552|OG002|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
11062964|NCT01371552|OG000|Outcome|Delefilcon A - All Wearers|Delefilcon A contact lenses worn in a daily disposable mode for 7 days in Part 2, all wearers
11062965|NCT01371552|EG000|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
11062966|NCT01371552|EG001|Reported Event|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
11062967|NCT01371552|EG002|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
11062968|NCT01371565|BG000|Baseline|Mifepristone|At doses from 300mg/day up to 1200mg/day
11062969|NCT01371565|FG000|Participant Flow|Mifepristone|At doses from 300mg/day up to 1200mg/day
11062970|NCT01371565|OG000|Outcome|Mifepristone|At doses from 300mg/day up to 1200mg/day
11062971|NCT01371565|EG000|Reported Event|Mifepristone|At doses from 300mg/day up to 1200mg/day
11062972|NCT01371643|BG000|Baseline|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
11062973|NCT01371643|BG001|Baseline|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
11062974|NCT01371643|BG002|Baseline|Total|Total of all reporting groups
11062975|NCT01371643|FG000|Participant Flow|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
11062976|NCT01371643|FG001|Participant Flow|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
11062977|NCT01371643|OG000|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
11062978|NCT01371643|OG001|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
11062979|NCT01371643|EG000|Reported Event|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
11062980|NCT01371643|EG001|Reported Event|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
11062981|NCT01371656|BG000|Baseline|Arm I (Levofloxacin)|"Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.~levofloxacin: Given PO or IV"
11062982|NCT01371656|BG001|Baseline|Arm II (Standard of Care)|Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
11062983|NCT01371656|BG002|Baseline|Total|Total of all reporting groups
11062984|NCT01371656|FG000|Participant Flow|Arm I (Levofloxacin)|"Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.~levofloxacin: Given PO or IV"
11062985|NCT01371656|FG001|Participant Flow|Arm II (Standard of Care)|Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
11062986|NCT01371656|OG000|Outcome|Arm I (Levofloxacin)|"Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.~levofloxacin: Given PO or IV"
11062987|NCT01371656|OG001|Outcome|Arm II (Standard of Care)|Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
11062988|NCT01371656|EG000|Reported Event|Arm I (Levofloxacin)|"Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.~levofloxacin: Given PO or IV"
11062989|NCT01371656|EG001|Reported Event|Arm II (Standard of Care)|Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
11062990|NCT01371708|BG000|Baseline|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11062991|NCT01371708|BG001|Baseline|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11062992|NCT01371708|BG002|Baseline|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11062993|NCT01371708|BG003|Baseline|Total|Total of all reporting groups
11062994|NCT01371708|FG000|Participant Flow|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11062995|NCT01371708|FG001|Participant Flow|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11062996|NCT01371708|FG002|Participant Flow|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11062997|NCT01371708|OG000|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11062998|NCT01371708|OG001|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
10849062|NCT00293462|BG003|Baseline|Total|Total of all reporting groups
10849063|NCT00293462|FG000|Participant Flow|Arm I: GM-CSF Group (GG)|Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
10849064|NCT00293462|FG001|Participant Flow|Arm II: Salt & Soda Group (SS)|Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
10849065|NCT00293462|FG002|Participant Flow|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
10849066|NCT00293462|OG000|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
11062999|NCT01371708|OG002|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11063000|NCT01371708|OG000|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
11063001|NCT01371708|EG000|Reported Event|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11063002|NCT01371708|EG001|Reported Event|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11063003|NCT01371708|EG002|Reported Event|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11063004|NCT01371708|EG003|Reported Event|Combination Group|Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
11063005|NCT01371721|BG000|Baseline|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063006|NCT01371721|BG001|Baseline|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063007|NCT01371721|BG002|Baseline|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063008|NCT01371721|BG003|Baseline|Total|Total of all reporting groups
11063009|NCT01371721|FG000|Participant Flow|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063010|NCT01371721|FG001|Participant Flow|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
10849067|NCT00293462|OG001|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
11063011|NCT01371721|FG002|Participant Flow|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063012|NCT01371721|OG000|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
10849068|NCT00293462|OG002|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
10849069|NCT00293462|EG000|Reported Event|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
10849070|NCT00293462|EG001|Reported Event|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
10849071|NCT00293462|EG002|Reported Event|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
10849072|NCT00293540|BG000|Baseline|A Mid-luteal Surgery|
10849073|NCT00293540|BG001|Baseline|B Mid-follicular Surgery|
10849074|NCT00293540|BG002|Baseline|Total|Total of all reporting groups
10849075|NCT00293540|FG000|Participant Flow|A Mid-luteal Surgery|
10849076|NCT00293540|FG001|Participant Flow|B Mid-follicular Surgery|
10849077|NCT00293540|OG000|Outcome|A Mid-luteal Surgery|
10849078|NCT00293540|OG001|Outcome|B Mid-follicular Surgery|
10849079|NCT00293540|EG000|Reported Event|A Mid-luteal Surgery|
10849080|NCT00293540|EG001|Reported Event|B Mid-follicular Surgery|
10849081|NCT00293579|BG000|Baseline|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
10849082|NCT00293579|FG000|Participant Flow|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
10849083|NCT00293579|OG000|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
10849084|NCT00293579|OG000|Outcome|Pemetrexed|"pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles~Pemetrexed: 500 mg/m2 IV every 3 weeks for 6 cycles"
10849085|NCT00293579|EG000|Reported Event|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
10849086|NCT00293709|BG000|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
10849087|NCT00293709|FG000|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
10849088|NCT00293709|OG000|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
10849089|NCT00293709|EG000|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
10849090|NCT00293722|BG000|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
10849091|NCT00293722|FG000|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
11063013|NCT01371721|OG001|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063014|NCT01371721|OG002|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063015|NCT01371721|OG003|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063016|NCT01371721|EG000|Reported Event|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063017|NCT01371721|EG001|Reported Event|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063018|NCT01371721|EG002|Reported Event|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063019|NCT01371721|EG003|Reported Event|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
11063020|NCT01371734|BG000|Baseline|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063021|NCT01371734|BG001|Baseline|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063022|NCT01371734|BG002|Baseline|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063023|NCT01371734|BG003|Baseline|Total|Total of all reporting groups
11063024|NCT01371734|FG000|Participant Flow|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063025|NCT01371734|FG001|Participant Flow|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063026|NCT01371734|FG002|Participant Flow|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11341980|NCT03694548|FG001|Participant Flow|Part A Survey Parents of Patients in Part A (Group 2)|"Parents of adolescent patients with SCD and chronic pain from Group 1 completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD.~Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD."
11063027|NCT01371734|OG000|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063028|NCT01371734|OG001|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063029|NCT01371734|OG002|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063030|NCT01371734|EG000|Reported Event|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063031|NCT01371734|EG001|Reported Event|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063032|NCT01371734|EG002|Reported Event|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
11063033|NCT01371747|BG000|Baseline|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063034|NCT01371747|BG001|Baseline|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063035|NCT01371747|BG002|Baseline|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063036|NCT01371747|BG003|Baseline|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063037|NCT01371747|BG004|Baseline|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day
11063038|NCT01371747|BG005|Baseline|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063039|NCT01371747|BG006|Baseline|Total|Total of all reporting groups
11063040|NCT01371747|FG000|Participant Flow|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063041|NCT01371747|FG001|Participant Flow|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063042|NCT01371747|FG002|Participant Flow|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063043|NCT01371747|FG003|Participant Flow|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063044|NCT01371747|FG004|Participant Flow|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063045|NCT01371747|FG005|Participant Flow|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063046|NCT01371747|OG000|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063047|NCT01371747|OG001|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063048|NCT01371747|OG002|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063049|NCT01371747|OG003|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063050|NCT01371747|OG004|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063051|NCT01371747|OG005|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063052|NCT01371747|OG000|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day
11063053|NCT01371747|EG000|Reported Event|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063054|NCT01371747|EG001|Reported Event|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063055|NCT01371747|EG002|Reported Event|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063056|NCT01371747|EG003|Reported Event|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063057|NCT01371747|EG004|Reported Event|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063058|NCT01371747|EG005|Reported Event|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
11063059|NCT01371786|BG000|Baseline|Sequence Ciclesonide Nasal Aerosol /Mometsasone Aqueous|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
11063060|NCT01371786|BG001|Baseline|Sequence Mometasone Aqueous / Ciclesonide Nasal Aerosol|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canistermometasone Aqueous (AQ) nasal spray : A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
11063061|NCT01371786|BG002|Baseline|Total|Total of all reporting groups
11063062|NCT01371786|FG000|Participant Flow|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
11063063|NCT01371786|FG001|Participant Flow|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
11063064|NCT01371786|OG000|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
10849092|NCT00293722|OG000|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
11063065|NCT01371786|OG001|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
11063066|NCT01371786|EG000|Reported Event|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
11063067|NCT01371786|EG001|Reported Event|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
11063068|NCT01371825|BG000|Baseline|Open-Label Sebelipase Alfa|Participants received IV infusions of sebelipase alfa during the open-label treatment. Participants initially received 0.35 mg/kg qw and escalated to 1 mg/kg qw after demonstrating acceptable safety and tolerability during at least 2 infusions. One participant initiated treatment under a Temporary Use Authorization prior to enrollment, wherein the participant's dose was gradually escalated from 0.2 to 1 mg/kg over 4 weeks; the participant started the study at this dose. Participants on treatment for 96 weeks and on stable qw dosing for 24 weeks could be switched to a qow dosing schedule. In the event of protocol-defined disease progression at any time during treatment, a participant could receive a dose increase from 1 to 3 mg/kg qw and, if necessary, a dose increase to 5 mg/kg qw with Safety Committee approval. Participants dosed qow who met dose-escalation criteria were reverted to qw dosing or escalated to 1 or 3 mg/kg qow.
11063069|NCT01371825|FG000|Participant Flow|Open-Label Sebelipase Alfa|Participants received intravenous (IV) infusions of sebelipase alfa during the open-label treatment. Participants initially received 0.35 milligrams (mg)/kilogram (kg) once weekly (qw) and escalated to 1 mg/kg qw after demonstrating acceptable safety and tolerability during at least 2 infusions. One participant initiated treatment under a Temporary Use Authorization prior to enrollment, wherein the participant's dose was gradually escalated from 0.2 to 1 mg/kg over 4 weeks; the participant started the study at this dose. Participants on treatment for 96 weeks and on stable qw dosing for 24 weeks could be switched to an every other week (qow) dosing schedule. In the event of protocol-defined disease progression at any time during treatment, a participant could receive a dose increase from 1 to 3 mg/kg qw and a dose increase to 5 mg/kg qw with Safety Committee approval. Participants dosed qow who met dose-escalation criteria were reverted to qw dosing or escalated to 1 or 3 mg/kg qow.
11063070|NCT01371825|OG000|Outcome|Open-Label Sebelipase Alfa|Participants received IV infusions of sebelipase alfa during the open-label treatment. Participants initially received 0.35 mg/kg qw and escalated to 1 mg/kg qw after demonstrating acceptable safety and tolerability during at least 2 infusions. One participant initiated treatment under a Temporary Use Authorization prior to enrollment, wherein the participant's dose was gradually escalated from 0.2 to 1 mg/kg over 4 weeks; the participant started the study at this dose. Participants on treatment for 96 weeks and on stable qw dosing for 24 weeks could be switched to a qow dosing schedule. In the event of protocol-defined disease progression at any time during treatment, a participant could receive a dose increase from 1 to 3 mg/kg qw and, if necessary, a dose increase to 5 mg/kg qw with Safety Committee approval. Participants dosed qow who met dose-escalation criteria were reverted to qw dosing or escalated to 1 or 3 mg/kg qow.
11063071|NCT01371825|EG000|Reported Event|Open-Label Sebelipase Alfa|Participants received IV infusions of sebelipase alfa during the open-label treatment. Participants initially received 0.35 mg/kg qw and escalated to 1 mg/kg qw after demonstrating acceptable safety and tolerability during at least 2 infusions. One participant initiated treatment under a Temporary Use Authorization prior to enrollment, wherein the participant's dose was gradually escalated from 0.2 to 1 mg/kg over 4 weeks; the participant started the study at this dose. Participants on treatment for 96 weeks and on stable qw dosing for 24 weeks could be switched to a qow dosing schedule. In the event of protocol-defined disease progression at any time during treatment, a participant could receive a dose increase from 1 to 3 mg/kg qw and, if necessary, a dose increase to 5 mg/kg qw with Safety Committee approval. Participants dosed qow who met dose-escalation criteria were reverted to qw dosing or escalated to 1 or 3 mg/kg qow.
11063072|NCT01371838|BG000|Baseline|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
11063073|NCT01371838|BG001|Baseline|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
11063074|NCT01371838|BG002|Baseline|Total|Total of all reporting groups
11063075|NCT01371838|FG000|Participant Flow|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
11063076|NCT01371838|FG001|Participant Flow|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
11063077|NCT01371838|OG000|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
11063078|NCT01371838|OG001|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
11063079|NCT01371838|EG000|Reported Event|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
11063080|NCT01371838|EG001|Reported Event|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
11063081|NCT01371851|BG000|Baseline|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
11063082|NCT01371851|BG001|Baseline|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
11063083|NCT01371851|BG002|Baseline|Total|Total of all reporting groups
11063084|NCT01371851|FG000|Participant Flow|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
11063085|NCT01371851|FG001|Participant Flow|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
11063086|NCT01371851|OG000|Outcome|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
11063087|NCT01371851|OG001|Outcome|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
11063088|NCT01371851|EG000|Reported Event|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
11063089|NCT01371851|EG001|Reported Event|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
11063090|NCT01371877|BG000|Baseline|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
11063091|NCT01371877|BG001|Baseline|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
11063092|NCT01371877|BG002|Baseline|Total|Total of all reporting groups
11063093|NCT01371877|FG000|Participant Flow|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
11063094|NCT01371877|FG001|Participant Flow|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
11063095|NCT01371877|OG000|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
11063096|NCT01371877|OG001|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
11063097|NCT01371877|EG000|Reported Event|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
11063098|NCT01371877|EG001|Reported Event|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
11063099|NCT01371994|BG000|Baseline|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
11063100|NCT01371994|BG001|Baseline|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
11063101|NCT01371994|BG002|Baseline|Total|Total of all reporting groups
11063102|NCT01371994|FG000|Participant Flow|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
11063103|NCT01371994|FG001|Participant Flow|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
11063104|NCT01371994|OG000|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
11063105|NCT01371994|OG001|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
11063106|NCT01371994|EG000|Reported Event|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
11063107|NCT01371994|EG001|Reported Event|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
11063108|NCT01372085|BG000|Baseline|Part A (LY2584702)|Participants enrolled in Part A of the study received a single dose of 25 milligrams (mg) LY2584702 (LY) reference formulation [RF (capsule)] in a fasted state on Day 1.
11063109|NCT01372085|BG001|Baseline|Part A (Placebo)|Participants enrolled in Part A of the study received placebo in a fasted state on Day 1.
11063110|NCT01372085|BG002|Baseline|10 mg LY TF, Placebo, 50 mg LY TF, 50 mg LY TF Fed|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 test formulation [TF (tablet)], placebo, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods.
11063111|NCT01372085|BG003|Baseline|Placebo, 50 mg LY RF, 50 mg LY TF, 50 mg LY TF Fed|Participants enrolled in Part B of the study received a single dose of placebo, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods.
11063112|NCT01372085|BG004|Baseline|Placebo, 50 mg LY RF, 50 mg LY TF, 200 mg LY TF Fasted|Participants enrolled in Part B of the study received a single dose of placebo, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods.
11063113|NCT01372085|BG005|Baseline|10 mg LY TF, 50 mg LY RF, 50 mg LY TF, 50 mg LY TF Fed|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods.
11063114|NCT01372085|BG006|Baseline|10 mg LY TF, 50 mg LY RF, 50 mg LY TF, 200 mg LY TF Fasted|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods.
11063115|NCT01372085|BG007|Baseline|10 mg LY TF, 50 mg LY RF, 50 mg LY TF, Placebo Fasted|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and placebo in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods.
11063116|NCT01372085|BG008|Baseline|10 mg LY TF, 50 mg LY RF, Placebo, 200 mg LY TF Fasted|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and placebo in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods.
11063117|NCT01372085|BG009|Baseline|200 mg LY TF Fasted|Participant enrolled in Part B, Period 4b of the study received a single dose of 200 mg LY2584702 TF in a fasted state on Day 1.
11063118|NCT01372085|BG010|Baseline|Total|Total of all reporting groups
11063119|NCT01372085|FG000|Participant Flow|LY2584702|Participants enrolled in Part A of the study received a single dose of 25 milligrams (mg) LY2584702 (LY) reference formulation [RF (capsule)] in a fasted state on Day 1.
11063120|NCT01372085|FG001|Participant Flow|Placebo|Participants enrolled in Part A of the study received placebo in a fasted state on Day 1.
11063121|NCT01372085|FG002|Participant Flow|10 mg LY TF, Placebo, 50 mg LY TF, 50 mg LY TF Fed|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 test formulation [TF (tablet)], placebo, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods.
11063122|NCT01372085|FG003|Participant Flow|Placebo, 50 mg LY RF, 50 mg LY TF, 50 mg LY TF Fed|Participants enrolled in Part B of the study received a single dose of placebo, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods.
11063123|NCT01372085|FG004|Participant Flow|Placebo, 50 mg LY RF, 50 mg LY TF, 200 mg LY TF Fasted|Participants enrolled in Part B of the study received a single dose of placebo, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods.
11063124|NCT01372085|FG005|Participant Flow|10 mg LY TF, 50 mg LY RF, 50 mg LY TF, 50 mg LY TF Fed|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods.
11063125|NCT01372085|FG006|Participant Flow|10 mg LY TF, 50 mg LY RF, 50 mg LY TF, 200 mg LY TF Fasted|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods.
11063126|NCT01372085|FG007|Participant Flow|10 mg LY TF, 50 mg LY RF, 50 mg LY TF, Placebo Fasted|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and placebo in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods.
11063127|NCT01372085|FG008|Participant Flow|10 mg LY TF, 50 mg LY RF, Placebo, 200 mg LY TF Fasted|Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and placebo in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods.
11063128|NCT01372085|FG009|Participant Flow|200 mg LY TF Fasted|Participant enrolled in Part B, Period 4b of the study received a single dose of 200 mg LY2584702 TF in a fasted state on Day 1.
11063129|NCT01372085|OG000|Outcome|25 mg LY2584702 RF Fasted|Participants received a 25 milligram (mg) LY2584702 RF orally in a fasted state on Day 1 in Part A of the study.
11063130|NCT01372085|OG001|Outcome|10 mg LY2584702 TF Fasted|Participants received 10 mg of LY2584702 TF orally in a fasted state, in Period 1, Day 1 of Part B of the study.
11063131|NCT01372085|OG002|Outcome|50 mg LY2584702 RF Fasted|Participants received 50 mg of LY2584702 RF orally in a fasted state, in Period 2, Day 1 of Part B of the study.
11063132|NCT01372085|OG003|Outcome|50 mg LY2584702 TF Fasted|Participants received 50 mg of LY2584702 TF orally in a fasted state, in Period 3, Day 1 of Part B of the study.
11063133|NCT01372085|OG004|Outcome|50 mg LY2584702 TF Fed|Participants received 50 mg of LY2584702 TF orally in a fed state, in Period 4a, Day 1 of Part B of the study.
11063134|NCT01372085|OG005|Outcome|200 mg LY2584702 TF Fasted|Participants received 200 mg of LY2584702 TF orally in a fasted state, in Period 4b, Day 1 of Part B of the study.
11063135|NCT01372085|OG000|Outcome|50 mg LY2584702 TF Fasted|Participants received 50 mg of LY2584702 TF orally in a fasted state, in Period 3, Day 1 of Part B of the study.
11063136|NCT01372085|OG001|Outcome|50 mg LY2584702 TF Fed|Participants received 50 mg of LY2584702 TF orally in a fed state, in Period 4a, Day 1 of Part B of the study.
11063137|NCT01372085|OG000|Outcome|25 mg LY2584702 RF Fasted|Participants received a 25 milligram (mg) LY2584702 RF orally, in a fasted state on Day 1 in Part A of the study.
11063138|NCT01372085|OG000|Outcome|10 mg LY2584702 TF Fasted|Participants received 10 milligrams (mg) of LY2584702 TF orally in a fasted state in Period 1, Day 1 of Part B of the study.
11063139|NCT01372085|OG001|Outcome|50 mg LY2584702 RF Fasted|Participants received 50 mg of LY2584702 RF orally in a fasted state in Period 2, Day 1 of Part B of the study.
11063140|NCT01372085|OG002|Outcome|50 mg LY2584702 TF Fasted|Participants received 50 mg of LY2584702 TF orally in a fasted state in Period 3, Day 1 of Part B of the study.
11063141|NCT01372085|OG003|Outcome|50 mg LY2584702 TF Fed|Participants received 50 mg of LY2584702 TF orally in a fed state in Period 4a, Day 1 of Part B of the study.
11063142|NCT01372085|OG004|Outcome|200 mg LY2584702 TF Fasted|Participants received 200 mg of LY2584702 TF orally in a fasted state in Period 4b, Day 1 of Part B of the study.
11063143|NCT01372085|OG005|Outcome|Placebo (Part B)|Participants received placebo orally in a fasted state, in Periods 1 to 4, Day 1 of Part B of the study.
11063144|NCT01372085|EG000|Reported Event|Placebo|Participants received placebo orally in fasted state on Day 1 in Part A and Periods 1 to 4, Day 1 in Part B of the study.
11063145|NCT01372085|EG001|Reported Event|25 mg LY2584702 RF Fasted|Participants received a 25 milligram (mg) LY2584702 reference formulation [RF (capsule)] orally in a fasted state on Day 1 in Part A of the study.
11063146|NCT01372085|EG002|Reported Event|10 mg LY2584702 TF Fasted|Participants received 10 mg of LY2584702 test formulation [TF (tablet)] orally in a fasted state, in Period 1, Day 1 of Part B of the study.
11063147|NCT01372085|EG003|Reported Event|50 mg LY2584702 RF Fasted|Participants received 50 mg of LY2584702 RF orally in a fasted state, in Period 2, Day 1 of Part B of the study.
11063148|NCT01372085|EG004|Reported Event|50 mg LY2584702 TF Fasted|Participants received 50 mg of LY2584702 TF orally in a fasted state, in Period 3, Day 1 of Part B of the study.
11063149|NCT01372085|EG005|Reported Event|50 mg LY2584702 TF Fed|Participants received 50 mg of LY2584702 TF orally in a fed state, in Period 4a, Day 1 of Part B of the study.
11063150|NCT01372085|EG006|Reported Event|200 mg LY2584702 TF Fasted|Participants received 200 mg of LY2584702 TF orally in a fasted state, in Period 4b, Day 1 of Part B of the study.
11063151|NCT01372150|BG000|Baseline|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
11063152|NCT01372150|BG001|Baseline|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
11063153|NCT01372150|BG002|Baseline|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
11063154|NCT01372150|BG003|Baseline|Total|Total of all reporting groups
11063155|NCT01372150|FG000|Participant Flow|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
11063156|NCT01372150|FG001|Participant Flow|Fluoxetine|Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
11063157|NCT01372150|FG002|Participant Flow|Desvenlafaxine Succinate Sustained Release (DVS SR)|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
11063158|NCT01372150|OG000|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
11063159|NCT01372150|OG001|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
11063160|NCT01372150|OG002|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
11063161|NCT01372150|EG000|Reported Event|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
11063162|NCT01372150|EG001|Reported Event|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
11063163|NCT01372150|EG002|Reported Event|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
10849093|NCT00293722|EG000|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
11063164|NCT01372202|BG000|Baseline|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy~Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56)."
11149517|NCT01871285|BG001|Baseline|MSE Dose Group 2|Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
11149518|NCT01871285|BG002|Baseline|Total|Total of all reporting groups
11063165|NCT01372202|BG001|Baseline|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu: Oxaliplatin & 5-fu:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation~Cisplatin/5-fluorouracil:~5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
11063166|NCT01372202|BG002|Baseline|Arm C|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
11063167|NCT01372202|BG003|Baseline|Total|Total of all reporting groups
11063168|NCT01372202|FG000|Participant Flow|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy~Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56)."
11063169|NCT01372202|FG001|Participant Flow|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu: Oxaliplatin & 5-fu:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation~Cisplatin/5-fluorouracil:~5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
11063170|NCT01372202|FG002|Participant Flow|Cisplatin With 5 Fu|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
11063171|NCT01372202|OG000|Outcome|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy~Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56)."
11063172|NCT01372202|OG001|Outcome|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu: Oxaliplatin & 5-fu:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation~Cisplatin/5-fluorouracil:~5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
11063173|NCT01372202|OG002|Outcome|Arm C|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
11063174|NCT01372202|OG001|Outcome|Arm B|"Cisplatin or Oxaliplatin, 5-Fluorouracil along , Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hs days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fluorouracil: Oxaliplatin and 5-fluorouracil:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the opera"
11063175|NCT01372202|OG002|Outcome|Arm C|"Cisplatin with 5-Fluorouracil with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~5-Fluorouracil: Oxaliplatin and 5-fluorouracil:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks star"
11063176|NCT01372202|OG001|Outcome|Arm B|"Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fluorouracil: Oxaliplatin and 5-fluorouracil:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the opera"
11063177|NCT01372202|OG002|Outcome|Arm C|"Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~5-Fluorouracil: Oxaliplatin and 5-fluorouracil:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks star"
11063178|NCT01372202|OG002|Outcome|Cisplatin With 5 Fu|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
11063179|NCT01372202|EG000|Reported Event|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy~Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56)."
11063180|NCT01372202|EG001|Reported Event|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu: Oxaliplatin & 5-fu:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation~Cisplatin/5-fluorouracil:~5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
11063181|NCT01372202|EG002|Reported Event|Arm C|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
11063182|NCT01372384|BG000|Baseline|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
11063183|NCT01372384|FG000|Participant Flow|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
11063184|NCT01372384|OG000|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
11063185|NCT01372384|EG000|Reported Event|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
11063186|NCT01372410|BG000|Baseline|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063187|NCT01372410|FG000|Participant Flow|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063188|NCT01372410|FG001|Participant Flow|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063189|NCT01372410|FG002|Participant Flow|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063190|NCT01372410|FG003|Participant Flow|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063191|NCT01372410|FG004|Participant Flow|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063192|NCT01372410|FG005|Participant Flow|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
10849094|NCT00293813|BG000|Baseline|Alendronate 70 mg QW|Alendronate 70 mg QW
10849095|NCT00293813|BG001|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
10849096|NCT00293813|BG002|Baseline|Placebo|Placebo
11063193|NCT01372410|FG006|Participant Flow|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063194|NCT01372410|FG007|Participant Flow|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063195|NCT01372410|OG000|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063196|NCT01372410|OG000|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063197|NCT01372410|OG001|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063198|NCT01372410|OG002|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063199|NCT01372410|OG003|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063200|NCT01372410|OG004|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063201|NCT01372410|OG005|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063202|NCT01372410|OG006|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063203|NCT01372410|OG007|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063204|NCT01372410|EG000|Reported Event|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063205|NCT01372410|EG001|Reported Event|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063206|NCT01372410|EG002|Reported Event|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063207|NCT01372410|EG003|Reported Event|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063208|NCT01372410|EG004|Reported Event|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
10849097|NCT00293813|BG003|Baseline|Total|Total of all reporting groups
10849098|NCT00293813|FG000|Participant Flow|Alendronate 70 mg QW|Alendronate 70 mg QW
11063209|NCT01372410|EG005|Reported Event|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063210|NCT01372410|EG006|Reported Event|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063211|NCT01372410|EG007|Reported Event|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
11063212|NCT01372462|BG000|Baseline|Overall Study Group|Crossover design. Subject were randomized to complete all 4 study arms: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment
11063213|NCT01372462|FG000|Participant Flow|All Study Participants|"All subjects completed all 4 visit days in which they were randomized to receive which treatment to receive first: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment.~Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen."
11063214|NCT01372462|OG000|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
11063215|NCT01372462|OG001|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
11063216|NCT01372462|OG002|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
11063217|NCT01372462|OG003|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
11063218|NCT01372462|EG000|Reported Event|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
11063219|NCT01372462|EG001|Reported Event|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
11063220|NCT01372462|EG002|Reported Event|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
11063221|NCT01372462|EG003|Reported Event|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
11063222|NCT01372501|BG000|Baseline|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
11063223|NCT01372501|FG000|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
11063224|NCT01372501|OG000|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
11063225|NCT01372501|OG000|Outcome|EndoBarrier Liner Device|Endobarrier Liner: Medical device placed endoscopically in the duodenum
11063226|NCT01372501|EG000|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
11063227|NCT01372605|BG000|Baseline|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
11063228|NCT01372605|BG001|Baseline|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
11063229|NCT01372605|BG002|Baseline|Total|Total of all reporting groups
11063230|NCT01372605|FG000|Participant Flow|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
11063231|NCT01372605|FG001|Participant Flow|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
11063232|NCT01372605|OG000|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
11063233|NCT01372605|OG001|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
11149519|NCT01871285|FG000|Participant Flow|MSE Dose Group 1 (AB) - Buprenorphine (300 μg) Then ATC Opioid|MSE Dose Group 1 receiving treatment sequence AB with A being buprenorphine hydrochloride (HCl) buccal film (300 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
11063234|NCT01372605|EG000|Reported Event|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
11063235|NCT01372605|EG001|Reported Event|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
11063236|NCT01372748|BG000|Baseline|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
11063237|NCT01372748|BG001|Baseline|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
11063238|NCT01372748|BG002|Baseline|Total|Total of all reporting groups
11063239|NCT01372748|FG000|Participant Flow|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
11063240|NCT01372748|FG001|Participant Flow|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
11063241|NCT01372748|OG000|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
11063242|NCT01372748|OG001|Outcome|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
11063243|NCT01372748|EG000|Reported Event|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
11063244|NCT01372748|EG001|Reported Event|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
11063245|NCT01372774|BG000|Baseline|Arm I - WBRT|"Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.~whole-brain radiation therapy: Undergo radiotherapy (RT)"
11063246|NCT01372774|BG001|Baseline|Arm II - SRS|"Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.~stereotactic radiosurgery: Undergo RT"
11063247|NCT01372774|BG002|Baseline|Total|Total of all reporting groups
11063248|NCT01372774|FG000|Participant Flow|Arm I - WBRT|"Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.~whole-brain radiation therapy: Undergo radiotherapy (RT)"
11063249|NCT01372774|FG001|Participant Flow|Arm II - SRS|"Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.~stereotactic radiosurgery: Undergo RT"
11063250|NCT01372774|OG000|Outcome|Arm I - WBRT|"Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.~whole-brain radiation therapy: Undergo radiotherapy (RT)"
11063251|NCT01372774|OG001|Outcome|Arm II - SRS|"Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.~stereotactic radiosurgery: Undergo RT"
11063252|NCT01372774|OG000|Outcome|Arm I - WBRT|Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.
10849099|NCT00293813|FG001|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
10849100|NCT00293813|FG002|Participant Flow|Placebo|Placebo
10849101|NCT00293813|OG000|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
10849102|NCT00293813|OG001|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
11063253|NCT01372774|OG001|Outcome|Arm II - SRS|Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.
11063254|NCT01372774|EG000|Reported Event|Arm I - WBRT|whole-brain radiation therapy: Undergo radiotherapy (RT)
11063255|NCT01372774|EG001|Reported Event|Arm II - SRS|stereotactic radiosurgery: Undergo RT
11063256|NCT01372813|BG000|Baseline|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
11063257|NCT01372813|FG000|Participant Flow|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
11063258|NCT01372813|OG000|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
11063259|NCT01372813|EG000|Reported Event|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
11063260|NCT01372878|BG000|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
11063261|NCT01372878|FG000|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
11063262|NCT01372878|OG000|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
11063263|NCT01372878|EG000|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
11063264|NCT01372995|BG000|Baseline|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
11063265|NCT01372995|BG001|Baseline|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
11063266|NCT01372995|BG002|Baseline|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
11063267|NCT01372995|BG003|Baseline|Total|Total of all reporting groups
11063268|NCT01372995|FG000|Participant Flow|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
11063269|NCT01372995|FG001|Participant Flow|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
11063270|NCT01372995|FG002|Participant Flow|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
11063271|NCT01372995|OG000|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
11063272|NCT01372995|OG001|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
11063273|NCT01372995|OG002|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
11063274|NCT01372995|EG000|Reported Event|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
11063275|NCT01372995|EG001|Reported Event|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally.
11063276|NCT01372995|EG002|Reported Event|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally.
11063277|NCT01373164|BG000|Baseline|Phase 1b: 80 mg Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063278|NCT01373164|BG001|Baseline|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11341981|NCT03694548|FG002|Participant Flow|Part B Yoga Program|"Participants from Part A Group 1 had the opportunity to enroll in Part B to receive eight in-person instructor-led group yoga sessions.~Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions."
10849103|NCT00293813|OG002|Outcome|Placebo|Placebo
10849104|NCT00293813|EG000|Reported Event|Placebo|
11063279|NCT01373164|BG002|Baseline|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063280|NCT01373164|BG003|Baseline|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11226759|NCT02377817|BG001|Baseline|Sham PrenaBelt on First Night, PrenaBelt on Second Night|"These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night.~PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.~Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points."
11226760|NCT02377817|BG002|Baseline|Total|Total of all reporting groups
11063281|NCT01373164|BG004|Baseline|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. participants may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met."
11063282|NCT01373164|BG005|Baseline|Total|Total of all reporting groups
11063283|NCT01373164|FG000|Participant Flow|Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 (milligrams per square meter) was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063284|NCT01373164|FG001|Participant Flow|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063285|NCT01373164|FG002|Participant Flow|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063286|NCT01373164|FG003|Participant Flow|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063287|NCT01373164|FG004|Participant Flow|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063288|NCT01373164|OG000|Outcome|Phase 1b Participants|Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
11063289|NCT01373164|OG000|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063290|NCT01373164|OG001|Outcome|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met."
11063291|NCT01373164|OG000|Outcome|Phase 1b: 80 mg Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063292|NCT01373164|OG001|Outcome|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063293|NCT01373164|OG002|Outcome|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063294|NCT01373164|OG001|Outcome|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063295|NCT01373164|OG001|Outcome|Placebo+Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063296|NCT01373164|EG000|Reported Event|Phase 1b: 80 mg Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063297|NCT01373164|EG001|Reported Event|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063298|NCT01373164|EG002|Reported Event|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063299|NCT01373164|EG003|Reported Event|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063300|NCT01373164|EG004|Reported Event|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
11063301|NCT01373229|BG000|Baseline|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
11063302|NCT01373229|FG000|Participant Flow|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
11063303|NCT01373229|OG000|Outcome|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
11063304|NCT01373229|EG000|Reported Event|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
11063305|NCT01373242|BG000|Baseline|Peanut ( Liquid Peanut Extract) SLIT|"All subjects will receive peanut SLIT upon enrollment for at least the first 48 months. After the desensitization DBPCFC after at least 48 months of treatment, subjects will be randomized off treatment from 1 to 17 weeks. Subjects will then undergo another DBPCFC.~Liquid peanut extract (Peanut SLIT): Liquid peanut extract will be administered under the tongue"
11063306|NCT01373242|FG000|Participant Flow|Peanut (Liquid Peanut Extract) SLIT|"All subjects will receive peanut SLIT upon enrollment for at least 48 months and then undergo a desensitization DBPCFC. Subjects will then be randomized to be off treatment for a period between 1 to 17 weeks. Subjects will then undergo a final DBPCFC.~Liquid peanut extract (Peanut SLIT): Liquid peanut extract will be administered under the tongue"
11063307|NCT01373242|OG000|Outcome|Peanut (Liquid Peanut Extract) SLIT|"All subjects will receive peanut SLIT upon enrollment for at least 48 months and then undergo a desensitization DBPCFC. Subjects will then be randomized to be off treatment for a period between 1 to 17 weeks. Subjects will then undergo a final DBPCFC.~Liquid peanut extract (Peanut SLIT): Liquid peanut extract will be administered under the tongue"
11063308|NCT01373242|OG000|Outcome|Desensitized After Peanut SLIT|All subjects will receive peanut SLIT upon enrollment for at least 48 months and then undergo a desensitization DBPCFC. 'Desensitized' defined as completing the 5000mg desensitization DBPCFC without dose limiting symptoms.
11063309|NCT01373242|OG001|Outcome|Non-desensitized After Peanut SLIT|All subjects will receive peanut SLIT upon enrollment for at least 48 months and then undergo a desensitization DBPCFC. 'Non-desensitized' defined as experiencing dose limiting symptoms during the 5000mg desensitization DBPCFC.
11063310|NCT01373242|EG000|Reported Event|Peanut (Liquid Peanut Extract) SLIT|"All subjects will receive peanut SLIT upon enrollment for at least 48 months and then undergo a desensitization DBPCFC. Subjects will then be randomized to be off treatment for a period between 1 to 17 weeks. Subjects will then undergo a final DBPCFC.~Liquid peanut extract (Peanut SLIT): Liquid peanut extract will be administered under the tongue"
11063311|NCT01373294|BG000|Baseline|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
11063312|NCT01373294|BG001|Baseline|B: Control Arm|Bacille Calmette-Guerrin (BCG).
11063313|NCT01373294|BG002|Baseline|Total|Total of all reporting groups
11063314|NCT01373294|FG000|Participant Flow|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
11063315|NCT01373294|FG001|Participant Flow|B: Control Arm|Bacille Calmette-Guerrin (BCG).
11063316|NCT01373294|OG000|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
11063317|NCT01373294|OG001|Outcome|B: Control Arm|Bacille Calmette-Guerrin (BCG).
11063318|NCT01373294|EG000|Reported Event|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
11063319|NCT01373294|EG001|Reported Event|B: Control Arm|Bacille Calmette-Guerrin (BCG).
11063320|NCT01373346|BG000|Baseline|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
11063321|NCT01373346|FG000|Participant Flow|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
11063322|NCT01373346|OG000|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
11063323|NCT01373346|OG000|Outcome|Long Limb Roux-en Y Reconstruction|Morbidity after operation were analyzed until end of study (on average 14.8 months)
11063324|NCT01373346|OG000|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
11063325|NCT01373346|OG000|Outcome|Long Limb Roux-en Y Reconstruction|"Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.~Until end of study (on average 14.8 months), operation related mortality of Gastric cancer patient with type 2 diabetes who receive total or Subtotal gastrectomy with long limb Roux en Y reconstruction were analyzed."
11063326|NCT01373346|OG000|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
11063327|NCT01373346|OG000|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|"Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.~'"
11063328|NCT01373346|EG000|Reported Event|Long-limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
11063329|NCT01373450|BG000|Baseline|All Treated Participants|
11063330|NCT01373450|FG000|Participant Flow|OXM --> Lg-0.6--> Pbo--> Lg-1.2|Participants received Oxyntomodulin (OXM) 3.0 pmol/kg/min in the first, Liraglutide (Lg) 0.6 mg in the second, Placebo (Pbo) in the third, and Liraglutide 1.2 mg in the fourth period
11063331|NCT01373450|FG001|Participant Flow|Lg-0.6 mg--> Pbo--> OXM--> Pbo|Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period
11063332|NCT01373450|FG002|Participant Flow|Pbo--> OXM--> Lg-0.6-->Pbo|Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
11063333|NCT01373450|FG003|Participant Flow|Lg-0.6--> OXM--> Pbo--> Lg-1.2|Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period
11063334|NCT01373450|FG004|Participant Flow|OXM--> Pbo--> Lg-0.6--> Pbo|Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
11063335|NCT01373450|FG005|Participant Flow|Pbo--> Lg-0.6--> OXM--> Lg-1.2|Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period
11063336|NCT01373450|OG000|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
11063337|NCT01373450|OG001|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
11063338|NCT01373450|OG000|Outcome|Placebo Period 1|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
11063339|NCT01373450|OG001|Outcome|Placebo Period 2|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
10849105|NCT00293813|EG001|Reported Event|Alendronate 70 mg QW|
11063340|NCT01373450|OG000|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
11063341|NCT01373450|OG001|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
11063342|NCT01373450|OG002|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
11063343|NCT01373450|OG003|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
11063344|NCT01373450|EG000|Reported Event|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
11063345|NCT01373450|EG001|Reported Event|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
11063346|NCT01373450|EG002|Reported Event|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
11063347|NCT01373450|EG003|Reported Event|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
11063348|NCT01373489|BG000|Baseline|Usual Care|Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.
11063349|NCT01373489|BG001|Baseline|Technology-assisted Case Management (TACM)|"This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach.~Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time."
11063350|NCT01373489|BG002|Baseline|Total|Total of all reporting groups
11063351|NCT01373489|FG000|Participant Flow|Usual Care|Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.
11063352|NCT01373489|FG001|Participant Flow|Technology-assisted Case Management (TACM)|"This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach.~Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time."
11063353|NCT01373489|OG000|Outcome|Usual Care|Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.
11063354|NCT01373489|OG001|Outcome|Technology-assisted Case Management (TACM)|"This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach.~Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time."
11063355|NCT01373489|EG000|Reported Event|Usual Care|Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.
11063356|NCT01373489|EG001|Reported Event|Technology-assisted Case Management (TACM)|"This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach.~Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. Patients assigned the FORA 2-"
11063357|NCT01373580|BG000|Baseline|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
10849106|NCT00293813|EG002|Reported Event|Denosumab 60 mg Q6M|
10849107|NCT00294047|BG000|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11063358|NCT01373580|FG000|Participant Flow|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
11063359|NCT01373580|OG000|Outcome|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
11063360|NCT01373580|EG000|Reported Event|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
11063361|NCT01373671|BG000|Baseline|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
11063362|NCT01373671|FG000|Participant Flow|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
11063363|NCT01373671|OG000|Outcome|FFDM and DBT|FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration
11063364|NCT01373671|OG001|Outcome|FFDM Only|FFDM exam only
11063365|NCT01373671|EG000|Reported Event|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
11063366|NCT01373918|BG000|Baseline|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
11063367|NCT01373918|BG001|Baseline|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
11063368|NCT01373918|BG002|Baseline|Total|Total of all reporting groups
11063369|NCT01373918|FG000|Participant Flow|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
11063370|NCT01373918|FG001|Participant Flow|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
11063371|NCT01373918|OG000|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
11063372|NCT01373918|OG001|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
11063373|NCT01373918|EG000|Reported Event|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
11063374|NCT01373918|EG001|Reported Event|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
11063375|NCT01373931|BG000|Baseline|OC + LY2216684 / OC + Placebo|"Lead-in Period: 28 days of Ortho Cyclen [OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo]~Period 1: OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo~Period 2: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo"
11063376|NCT01373931|BG001|Baseline|OC + Placebo / OC + LY2216684|"Lead-in Period: 28 days of OC (21 days of 35 mcg ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo)~Period 1: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo~Period 2: OC + 18 mg of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo"
11063377|NCT01373931|BG002|Baseline|Total|Total of all reporting groups
11063378|NCT01373931|FG000|Participant Flow|OC + LY2216684 / OC + Placebo|"Lead-in Period: 28 days of Ortho Cyclen [OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo]~Period 1: OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo~Period 2: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo"
11063379|NCT01373931|FG001|Participant Flow|OC + Placebo / OC + LY2216684|"Lead-in Period: 28 days of OC (21 days of 35 mcg ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo)~Period 1: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo~Period 2: OC + 18 mg of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo"
11063380|NCT01373931|OG000|Outcome|OC + LY2216684|Ortho Cyclen (OC) + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
11063381|NCT01373931|OG001|Outcome|OC + Placebo|OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
11063382|NCT01373931|EG000|Reported Event|OC Lead-in Period|Lead-in Period: 28 days of Ortho Cyclen [OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo]
11063383|NCT01373931|EG001|Reported Event|OC + LY2216684|OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
11063384|NCT01373931|EG002|Reported Event|OC + Placebo|OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences
11063385|NCT01374087|BG000|Baseline|Brachytherapy|Subjects were randomised to receive brachytherapy alone, as either a low dose rate ([125]I) or high dose rate ([192]I).
11063386|NCT01374087|BG001|Baseline|Brachytherapy + Triptorelin 22.5 mg|Subjects received brachytherapy as either a low dose rate ([125]I) or high dose rate ([192]I). Subjects also received a single intramuscular injection of 22.5 mg triptorelin at Visit 2 (Day 1).
11063387|NCT01374087|BG002|Baseline|Total|Total of all reporting groups
11063388|NCT01374087|FG000|Participant Flow|Brachytherapy|Subjects were randomised to receive brachytherapy alone, as either a low dose rate ([125]I) or high dose rate ([192]I).
11063389|NCT01374087|FG001|Participant Flow|Brachytherapy + Triptorelin 22.5 mg|Subjects received brachytherapy as either a low dose rate ([125]I) or high dose rate ([192]I). Subjects also received a single intramuscular injection of 22.5 milligrams (mg) triptorelin at Visit 2 (Day 1).
11063390|NCT01374087|OG000|Outcome|Brachytherapy|Subjects were randomised to receive brachytherapy alone, as either a low dose rate ([125]I) or high dose rate ([192]I).
11063391|NCT01374087|OG001|Outcome|Brachytherapy + Triptorelin 22.5 mg|Subjects received brachytherapy as either a low dose rate ([125]I) or high dose rate ([192]I). Subjects also received a single intramuscular injection of 22.5 mg triptorelin at Visit 2 (Day 1).
11063392|NCT01374087|EG000|Reported Event|Brachytherapy|Subjects were randomised to receive brachytherapy alone, as either a low dose rate ([125]I) or high dose rate ([192]I).
11063393|NCT01374087|EG001|Reported Event|Brachytherapy + Triptorelin 22.5 mg|Subjects received brachytherapy as either a low dose rate ([125]I) or high dose rate ([192]I). Subjects also received a single intramuscular injection of 22.5 mg triptorelin at Visit 2 (Day 1).
11063394|NCT01374178|BG000|Baseline|Entire Study Population|"For the LY2963016 first, then Lantus group: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).~For the Lantus first, then LY2963016 group: A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours)."
11063395|NCT01374178|FG000|Participant Flow|LY2963016 First, Then Lantus|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
11063396|NCT01374178|FG001|Participant Flow|Lantus First, Then LY2963016|A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).
11063397|NCT01374178|OG000|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
11063398|NCT01374178|OG001|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
11063399|NCT01374178|EG000|Reported Event|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
11063400|NCT01374178|EG001|Reported Event|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
11063401|NCT01374217|BG000|Baseline|Tadalafil|"Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd)~Tadalafil: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days~Lenalidomide: Lenalidomide will be administered as it was prior to study entry.~Dexamethasone: Dexamethasone will be administered as it was prior to study entry.~Clarithromycin: Clarithromycin will be administered as it was prior to study entry."
11063402|NCT01374217|FG000|Participant Flow|Tadalafil|"Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd)~Tadalafil: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days~Lenalidomide: Lenalidomide will be administered as it was prior to study entry.~Dexamethasone: Dexamethasone will be administered as it was prior to study entry.~Clarithromycin: Clarithromycin will be administered as it was prior to study entry."
11063403|NCT01374217|OG000|Outcome|Tadalafil|"Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd)~Tadalafil: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days~Lenalidomide: Lenalidomide will be administered as it was prior to study entry.~Dexamethasone: Dexamethasone will be administered as it was prior to study entry.~Clarithromycin: Clarithromycin will be administered as it was prior to study entry."
11149520|NCT01871285|FG001|Participant Flow|MSE Dose Group 1 (BA) - ATC Opioid Then Buprenorphine (300 μg)|MSE Dose Group 1 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
11063404|NCT01374217|EG000|Reported Event|Tadalafil|"Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd)~Tadalafil: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days~Lenalidomide: Lenalidomide will be administered as it was prior to study entry.~Dexamethasone: Dexamethasone will be administered as it was prior to study entry.~Clarithromycin: Clarithromycin will be administered as it was prior to study entry."
11063405|NCT01374269|BG000|Baseline|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
11063406|NCT01374269|BG001|Baseline|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
11063407|NCT01374269|BG002|Baseline|Total|Total of all reporting groups
11063408|NCT01374269|FG000|Participant Flow|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
11063409|NCT01374269|FG001|Participant Flow|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
11063410|NCT01374269|OG000|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
11063411|NCT01374269|OG001|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
11063412|NCT01374269|EG000|Reported Event|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
11063413|NCT01374269|EG001|Reported Event|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
11063414|NCT01374425|BG000|Baseline|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
11063415|NCT01374425|BG001|Baseline|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
11063416|NCT01374425|BG002|Baseline|Total|Total of all reporting groups
11063417|NCT01374425|FG000|Participant Flow|Bevacizumab + mFOLFOX6|Participants with untreated metastatic colorectal cancer (mCRC) who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 milligrams per kilogram (mg/kg), leucovorin as 400 milligrams per meter-squared (mg/m^2), oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via intravenous (IV) infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
11063418|NCT01374425|FG001|Participant Flow|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
11063419|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
11063420|NCT01374425|OG001|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
11063421|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level greater than (>) 1.7 × 10^-3 ERCC-1/B-actin messenger ribonucleic acid (mRNA) at Baseline were included in separate analyses.
11063422|NCT01374425|OG001|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
11063423|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level less than or equal to (≤) 1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
11063424|NCT01374425|OG001|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
11063425|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
11063426|NCT01374425|OG001|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
11063427|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 picograms per milliliter (pg/mL) at Baseline were included in separate analyses.
11063428|NCT01374425|OG001|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
11063429|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
11063430|NCT01374425|OG001|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
11063431|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
11063432|NCT01374425|OG001|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
11063433|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
11066946|NCT01394276|BG000|Baseline|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
11063434|NCT01374425|OG001|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
11063435|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
11063436|NCT01374425|OG001|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
11063437|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
11063438|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
11063439|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
11063440|NCT01374425|OG001|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
11063441|NCT01374425|OG000|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
11149521|NCT01871285|FG002|Participant Flow|MSE Dose Group 2 (AB) - Buprenorphine (450 μg) Then ATC Opioid|MSE Dose Group 2 receiving treatment sequence AB with A being buprenorphine HCl buccal film (450 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
11063442|NCT01374425|EG000|Reported Event|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
11063443|NCT01374425|EG001|Reported Event|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
11063444|NCT01374438|BG000|Baseline|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
11063445|NCT01374438|BG001|Baseline|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
11063446|NCT01374438|BG002|Baseline|Total|Total of all reporting groups
11063447|NCT01374438|FG000|Participant Flow|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
11063448|NCT01374438|FG001|Participant Flow|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
11063449|NCT01374438|OG000|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
11063450|NCT01374438|OG001|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
11063451|NCT01374438|EG000|Reported Event|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
11063452|NCT01374438|EG001|Reported Event|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
11063453|NCT01374451|BG000|Baseline|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
11063454|NCT01374451|BG001|Baseline|Everolimus|everolimus 10 mg once daily po alone
11063455|NCT01374451|BG002|Baseline|Total|Total of all reporting groups
11063456|NCT01374451|FG000|Participant Flow|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
11063457|NCT01374451|FG001|Participant Flow|Everolimus|everolimus 10 mg once daily po alone
11063458|NCT01374451|OG000|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
11063459|NCT01374451|OG001|Outcome|Everolimus|everolimus 10 mg once daily po alone
11063460|NCT01374451|EG000|Reported Event|Everolimus LAR + Pasireotide|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
11063461|NCT01374451|EG001|Reported Event|Everolimus|everolimus 10 mg once daily po alone
11063462|NCT01374490|BG000|Baseline|Crofelemer|Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
11063463|NCT01374490|FG000|Participant Flow|Crofelemer|Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
11063464|NCT01374490|OG000|Outcome|Crofelemer|Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
11063465|NCT01374490|EG000|Reported Event|Crofelemer|Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
11063466|NCT01374568|BG000|Baseline|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
11063467|NCT01374568|BG001|Baseline|Placebo|"Placebo~Placebo: 1 pill daily"
11063468|NCT01374568|BG002|Baseline|Total|Total of all reporting groups
11063469|NCT01374568|FG000|Participant Flow|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
11063470|NCT01374568|FG001|Participant Flow|Placebo|"Placebo~Placebo: 1 pill daily"
11063471|NCT01374568|OG000|Outcome|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
11063472|NCT01374568|OG001|Outcome|Placebo|"Placebo~Placebo: 1 pill daily"
11063473|NCT01374568|EG000|Reported Event|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
11063474|NCT01374568|EG001|Reported Event|Placebo|"Placebo~Placebo: 1 pill daily"
11063475|NCT01374802|BG000|Baseline|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.~Period 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).~Period 2: faldaprevir together with DRV/r."
11063476|NCT01374802|FG000|Participant Flow|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.~Period 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).~Period 2: Faldaprevir together with DRV/r."
11063477|NCT01374802|OG000|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
11063478|NCT01374802|OG001|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
11063479|NCT01374802|EG000|Reported Event|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily
11063480|NCT01374802|EG001|Reported Event|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
11149522|NCT01871285|FG003|Participant Flow|MSE Dose Group 2 (BA) - ATC Opioid Then Buprenorphine (450 μg)|MSE Dose Group 2 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
11063481|NCT01374906|BG000|Baseline|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
11063482|NCT01374906|BG001|Baseline|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
11063483|NCT01374906|BG002|Baseline|Total|Total of all reporting groups
11063484|NCT01374906|FG000|Participant Flow|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
11063485|NCT01374906|FG001|Participant Flow|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
11063486|NCT01374906|OG000|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
11063487|NCT01374906|OG001|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
11063488|NCT01374906|OG002|Outcome|5 mg Pasireotide LAR Dose|These patients were dosed with 5 mg of Pasireotide LAR to assess Pharmacokinetics (PK).
11063489|NCT01374906|OG003|Outcome|40 mg Pasireotide LAR Dose|These patients were dosed with 40 mg of Pasireotide LAR to assess Pharmacokinetics (PK).
11063490|NCT01374906|OG002|Outcome|5 mg Pasireptide LAR Dose|These patients were dosed with 5 mg of Pasireotide LAR to assess Pharmacokinetics (PK).
11063491|NCT01374906|EG000|Reported Event|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
11063492|NCT01374906|EG001|Reported Event|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
11063493|NCT01374906|EG002|Reported Event|All Patients|All Patients from both the 10 mg and 30 mg groups.
11063494|NCT01374919|BG000|Baseline|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
11063495|NCT01374919|FG000|Participant Flow|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
11063496|NCT01374919|OG000|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
10849108|NCT00294047|BG001|Baseline|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
11063497|NCT01374919|EG000|Reported Event|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
11063498|NCT01374971|BG000|Baseline|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
11063499|NCT01374971|FG000|Participant Flow|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-Tumor Necrosis Factor (TNF), humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
11063500|NCT01374971|OG000|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
11063501|NCT01374971|EG000|Reported Event|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
10849109|NCT00294047|BG002|Baseline|Total|Total of all reporting groups
11063502|NCT01375010|BG000|Baseline|Group A|"Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.~Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.~Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D)."
11063503|NCT01375010|BG001|Baseline|Group B|"2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.~Vitamin D3: 2000 mg QD~Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D)."
11063504|NCT01375010|BG002|Baseline|Total|Total of all reporting groups
11063505|NCT01375010|FG000|Participant Flow|Group A|"Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.~Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.~Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D)."
11063506|NCT01375010|FG001|Participant Flow|Group B|"2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.~Vitamin D3: 2000 mg QD~Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D)."
11063507|NCT01375010|OG000|Outcome|Group A|"Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.~Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.~Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D)."
11063508|NCT01375010|OG001|Outcome|Group B|"2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.~Vitamin D3: 2000 mg QD~Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D)."
11063509|NCT01375010|EG000|Reported Event|Group A|"Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.~Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.~Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D)."
11063510|NCT01375010|EG001|Reported Event|Group B|"2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.~Vitamin D3: 2000 mg QD~Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D)."
11063511|NCT01375049|BG000|Baseline|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
11063512|NCT01375049|FG000|Participant Flow|AZLI|Participants received one 28-day course of Aztreonam for Inhalation Solution (AZLI), then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
11063513|NCT01375049|OG000|Outcome|AZLI - Evaluable Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.~The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196."
11063514|NCT01375049|OG000|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
11063515|NCT01375049|OG001|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
11063516|NCT01375049|OG000|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
11066947|NCT01394276|FG000|Participant Flow|Tocilizumab|Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra [Tocilizumab (TCZ)] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).
11063517|NCT01375049|OG000|Outcome|AZLI - Sensitivity Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.~The Sensitivity Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a PA-positive culture from Day 28 through Day 196 or used any additional antipseudomonal antibiotics from Day 28 through Day 196."
11063518|NCT01375049|EG000|Reported Event|AZLI|"Treatment-emergent adverse events and treatment-emergent serious adverse events were collected from Baseline through Day 28 plus 30 days.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
11063519|NCT01375075|BG000|Baseline|30 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 4 tablets~Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet"
11063520|NCT01375075|BG001|Baseline|100 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 4 tablets~Placebo (Atorvastatin): 1 capsule~LY2484595: A single 100-mg tablet"
11063521|NCT01375075|BG002|Baseline|500 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (Atorvastatin): 1 capsule~LY2484595: five 100-mg tablets"
11063522|NCT01375075|BG003|Baseline|Placebo|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 5 tablets~Placebo (Atorvastatin): 1 capsule"
11063523|NCT01375075|BG004|Baseline|10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~Placebo (LY2484595): 5 tablets"
11063524|NCT01375075|BG005|Baseline|100 mg LY2484595 + 10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~LY2484595: A single 100-mg tablet~Placebo (LY2484595): 4 tablets"
11063525|NCT01375075|BG006|Baseline|Total|Total of all reporting groups
11063526|NCT01375075|FG000|Participant Flow|30 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 4 tablets~Placebo (Atorvastatin): 1 capsule~LY2484595: A single 30-milligram (mg) tablet"
11063527|NCT01375075|FG001|Participant Flow|100 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 4 tablets~Placebo (Atorvastatin): 1 capsule~LY2484595: A single 100-mg tablet"
11063528|NCT01375075|FG002|Participant Flow|500 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (Atorvastatin): 1 capsule~LY2484595: five 100-mg tablets"
11063529|NCT01375075|FG003|Participant Flow|Placebo|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 5 tablets~Placebo (Atorvastatin): 1 capsule"
11063530|NCT01375075|FG004|Participant Flow|10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~Placebo (LY2484595): 5 tablets"
11063531|NCT01375075|FG005|Participant Flow|100 mg LY2484595 + 10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~LY2484595: A single 100-mg tablet~Placebo (LY2484595): 4 tablets"
11063532|NCT01375075|OG000|Outcome|30 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 4 tablets~Placebo (Atorvastatin): 1 capsule~LY2484595: A single 30-milligram (mg) tablet"
11063533|NCT01375075|OG001|Outcome|100 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 4 tablets~Placebo (Atorvastatin): 1 capsule~LY2484595: A single 100-mg tablet"
11063534|NCT01375075|OG002|Outcome|500 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (Atorvastatin): 1 capsule~LY2484595: five 100-mg tablets"
11063535|NCT01375075|OG003|Outcome|Placebo|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 5 tablets~Placebo (Atorvastatin): 1 capsule"
11063536|NCT01375075|OG004|Outcome|10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~Placebo (LY2484595): 5 tablets"
11063537|NCT01375075|OG005|Outcome|100 mg LY2484595 + 10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~LY2484595: A single 100-mg tablet~Placebo (LY2484595): 4 tablets"
11063538|NCT01375075|OG000|Outcome|30 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo: 4 tablets and 1 capsule~LY2484595: A single 30-milligram (mg) tablet"
11063539|NCT01375075|OG001|Outcome|100 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo: 4 tablets and 1 capsule~LY2484595: A single 100-mg tablet"
11063540|NCT01375075|OG003|Outcome|100 mg LY2484595 + 10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~Placebo: 4 tablets~LY2484595: A single 100-mg tablet"
11063541|NCT01375075|OG000|Outcome|30 mg LY2484595|The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-milligram (mg) tablet
11063542|NCT01375075|EG000|Reported Event|30 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 4 tablets~Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet"
11063543|NCT01375075|EG001|Reported Event|100 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 4 tablets~Placebo (Atorvastatin): 1 capsule~LY2484595: A single 100-mg tablet"
11063544|NCT01375075|EG002|Reported Event|500 mg LY2484595|"The following were administered orally once daily for 12 weeks:~Placebo (Atorvastatin): 1 capsule~LY2484595: five 100-mg tablets"
11063545|NCT01375075|EG003|Reported Event|Placebo|"The following were administered orally once daily for 12 weeks:~Placebo (LY2484595): 5 tablets~Placebo (Atorvastatin): 1 capsule"
11063546|NCT01375075|EG004|Reported Event|10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~Placebo (LY2484595): 5 tablets"
11063547|NCT01375075|EG005|Reported Event|100 mg LY2484595 + 10 mg Atorvastatin|"The following were administered orally once daily for 12 weeks:~Atorvastatin: A single 10-mg capsule~LY2484595: A single 100-mg tablet~Placebo (LY2484595): 4 tablets"
11063548|NCT01375127|BG000|Baseline|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
11063549|NCT01375127|BG001|Baseline|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063550|NCT01375127|BG002|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063551|NCT01375127|BG003|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063552|NCT01375127|BG004|Baseline|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063553|NCT01375127|BG005|Baseline|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063554|NCT01375127|BG006|Baseline|Total|Total of all reporting groups
11063555|NCT01375127|FG000|Participant Flow|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
11063556|NCT01375127|FG001|Participant Flow|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063557|NCT01375127|FG002|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063558|NCT01375127|FG003|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063559|NCT01375127|FG004|Participant Flow|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063560|NCT01375127|FG005|Participant Flow|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063561|NCT01375127|OG000|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
11063562|NCT01375127|OG001|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063563|NCT01375127|OG002|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063564|NCT01375127|OG003|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063565|NCT01375127|OG004|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063566|NCT01375127|OG005|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063567|NCT01375127|EG000|Reported Event|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
11063568|NCT01375127|EG001|Reported Event|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063569|NCT01375127|EG002|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063570|NCT01375127|EG003|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063571|NCT01375127|EG004|Reported Event|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063572|NCT01375127|EG005|Reported Event|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
11063573|NCT01375140|BG000|Baseline|Ruxolitinib + Lenalidomide|"Ruxolitinib 15 mg orally twice daily continuously + Lenalidomide orally 5 mg/day on days 1-21, followed by 7 days of no therapy (28-day cycle). Prednisone will be added for patients who have not responded after 3 cycles of therapy. Prednisone 30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued.~Ruxolitinib: 15 mg by mouth twice daily (BID), continuously in 28-day cycles.~Lenalidomide: 5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.~Prednisone: Prednisone will be added for patients who have not responded after 3 cycles of therapy.~30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued."
11063574|NCT01375140|FG000|Participant Flow|Ruxolitinib + Lenalidomide|"Ruxolitinib 15 mg orally twice daily continuously + Lenalidomide orally 5 mg/day on days 1-21, followed by 7 days of no therapy (28-day cycle). Prednisone will be added for patients who have not responded after 3 cycles of therapy. Prednisone 30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued.~Ruxolitinib: 15 mg by mouth twice daily (BID), continuously in 28-day cycles.~Lenalidomide: 5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.~Prednisone: Prednisone will be added for patients who have not responded after 3 cycles of therapy.~30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued."
11063575|NCT01375140|OG000|Outcome|Ruxolitinib + Lenalidomide|"Ruxolitinib 15 mg orally twice daily continuously + Lenalidomide orally 5 mg/day on days 1-21, followed by 7 days of no therapy (28-day cycle). Prednisone will be added for patients who have not responded after 3 cycles of therapy. Prednisone 30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued.~Ruxolitinib: 15 mg by mouth twice daily (BID), continuously in 28-day cycles.~Lenalidomide: 5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.~Prednisone: Prednisone will be added for patients who have not responded after 3 cycles of therapy.~30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued."
11063576|NCT01375140|EG000|Reported Event|Ruxolitinib + Lenalidomide|"Ruxolitinib 15 mg orally twice daily continuously + Lenalidomide orally 5 mg/day on days 1-21, followed by 7 days of no therapy (28-day cycle). Prednisone will be added for patients who have not responded after 3 cycles of therapy. Prednisone 30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued.~Ruxolitinib: 15 mg by mouth twice daily (BID), continuously in 28-day cycles.~Lenalidomide: 5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.~Prednisone: Prednisone will be added for patients who have not responded after 3 cycles of therapy.~30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued."
11063577|NCT01375205|BG000|Baseline|Cetaphil Restoraderm|"Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.~Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."
11063578|NCT01375205|BG001|Baseline|Standard of Care|"Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.~Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser."
11063579|NCT01375205|BG002|Baseline|Total|Total of all reporting groups
11063580|NCT01375205|FG000|Participant Flow|Cetaphil Restoraderm|"Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.~Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."
11063581|NCT01375205|FG001|Participant Flow|Standard of Care|"Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.~Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser."
11063582|NCT01375205|OG000|Outcome|Cetaphil Restoraderm|"Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.~Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."
11063583|NCT01375205|OG001|Outcome|Standard of Care|"Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.~Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser."
11063584|NCT01375205|EG000|Reported Event|Cetaphil Restoraderm|"Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.~Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."
11063585|NCT01375205|EG001|Reported Event|Standard of Care|"Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.~Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser."
11063586|NCT01375374|BG000|Baseline|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
11063587|NCT01375374|FG000|Participant Flow|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
11063588|NCT01375374|OG000|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
11063589|NCT01375374|EG000|Reported Event|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
11063590|NCT01375491|BG000|Baseline|Doxycycline|"Participants with DM2 receiving doxycycline 100mg BID~Doxycycline : generic doxycycline 100mg twice daily"
11063591|NCT01375491|BG001|Baseline|Placebo|"Pills prepared identical to doxycycline.~Placebo : Placebo comparator to doxycycline"
11063592|NCT01375491|BG002|Baseline|Control|Participants enrolled without type 2 diabetes to serve as a control
11063593|NCT01375491|BG003|Baseline|Total|Total of all reporting groups
11063594|NCT01375491|FG000|Participant Flow|Doxycycline|"Participants with DM2 receiving doxycycline 100mg BID~Doxycycline : generic doxycycline 100mg twice daily"
11063595|NCT01375491|FG001|Participant Flow|Placebo|"Pills prepared identical to doxycycline.~Placebo : Placebo comparator to doxycycline"
11063596|NCT01375491|FG002|Participant Flow|Control|non- type two diabetics to serve as a control
11063597|NCT01375491|OG000|Outcome|Doxycycline|"Participants with DM2 receiving doxycycline 100mg BID~Doxycycline : generic doxycycline 100mg twice daily"
11063598|NCT01375491|OG001|Outcome|Placebo|"Pills prepared identical to doxycycline.~Placebo : Placebo comparator to doxycycline"
11063599|NCT01375491|OG002|Outcome|Control Arm|The study included non-DM2 controls (n = 15), but the non DM2 controls were not evaluated on day 84.
11063600|NCT01375491|EG000|Reported Event|Doxycycline|"Participants with DM2 receiving doxycycline 100mg BID~Doxycycline : generic doxycycline 100mg twice daily"
11063601|NCT01375491|EG001|Reported Event|Placebo|"Pills prepared identical to doxycycline.~Placebo : Placebo comparator to doxycycline"
11063602|NCT01375569|BG000|Baseline|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
11063603|NCT01375569|FG000|Participant Flow|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
11063604|NCT01375569|OG000|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
11063605|NCT01375569|EG000|Reported Event|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
11063606|NCT01375608|BG000|Baseline|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
11063607|NCT01375608|FG000|Participant Flow|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
11063608|NCT01375608|OG000|Outcome|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
11063609|NCT01375608|EG000|Reported Event|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
11063610|NCT01375660|BG000|Baseline|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
11063611|NCT01375660|BG001|Baseline|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
11063612|NCT01375660|BG002|Baseline|Total|Total of all reporting groups
11063613|NCT01375660|FG000|Participant Flow|Placebo|supplement of vitamin D 400 units provided to all subjects in addition to placebo.
11063614|NCT01375660|FG001|Participant Flow|50K Vitamin D2|supplement of vitamin D 400 units provided to all subjects in addition to 50K vitamin D2.
11063615|NCT01375660|OG000|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
11063616|NCT01375660|OG001|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
11063617|NCT01375660|OG000|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
11063618|NCT01375660|EG000|Reported Event|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
11063619|NCT01375660|EG001|Reported Event|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition get to D2 50K.
11063620|NCT01375673|BG000|Baseline|Exercise|Exercise: Walking Strength Training Bicycling
11063621|NCT01375673|BG001|Baseline|Standard of Care|Standard of Care
11063622|NCT01375673|BG002|Baseline|Total|Total of all reporting groups
11063623|NCT01375673|FG000|Participant Flow|Exercise|Exercise: Walking Strength Training Bicycling
11063624|NCT01375673|FG001|Participant Flow|Standard of Care|Standard of care
11063625|NCT01375673|OG000|Outcome|Exercise|Exercise: Walking Strength Training Bicycling
11063626|NCT01375673|OG001|Outcome|Standard of Care|Standard of Care
11063627|NCT01375673|EG000|Reported Event|Exercise|Exercise: Walking Strength Training Bicycling
11063628|NCT01375673|EG001|Reported Event|Standard of Care|Standard of Care
11063629|NCT01375751|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
11063630|NCT01375751|BG001|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063631|NCT01375751|BG002|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063632|NCT01375751|BG003|Baseline|Total|Total of all reporting groups
11063633|NCT01375751|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
11063634|NCT01375751|FG001|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063635|NCT01375751|FG002|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063636|NCT01375751|OG000|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
11063637|NCT01375751|OG001|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063638|NCT01375751|OG002|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063639|NCT01375751|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
11063640|NCT01375751|EG001|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063641|NCT01375751|EG002|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063642|NCT01375764|BG000|Baseline|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11063643|NCT01375764|BG001|Baseline|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11063644|NCT01375764|BG002|Baseline|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063645|NCT01375764|BG003|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063646|NCT01375764|BG004|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063647|NCT01375764|BG005|Baseline|Total|Total of all reporting groups
11063648|NCT01375764|FG000|Participant Flow|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11063649|NCT01375764|FG001|Participant Flow|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11063650|NCT01375764|FG002|Participant Flow|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063651|NCT01375764|FG003|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063652|NCT01375764|FG004|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063653|NCT01375764|OG000|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11063654|NCT01375764|OG001|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063655|NCT01375764|OG002|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063656|NCT01375764|OG003|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063657|NCT01375764|OG001|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11063658|NCT01375764|EG000|Reported Event|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11063659|NCT01375764|EG001|Reported Event|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063660|NCT01375764|EG002|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063661|NCT01375764|EG003|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063662|NCT01375764|EG004|Reported Event|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11063663|NCT01375777|BG000|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11063664|NCT01375777|BG001|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11063665|NCT01375777|BG002|Baseline|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
11063666|NCT01375777|BG003|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063667|NCT01375777|BG004|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063668|NCT01375777|BG005|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063669|NCT01375777|BG006|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063670|NCT01375777|BG007|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063671|NCT01375777|BG008|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063672|NCT01375777|BG009|Baseline|Total|Total of all reporting groups
11063673|NCT01375777|FG000|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11063674|NCT01375777|FG001|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11063675|NCT01375777|FG002|Participant Flow|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
11063676|NCT01375777|FG003|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063677|NCT01375777|FG004|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063678|NCT01375777|FG005|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063679|NCT01375777|FG006|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063680|NCT01375777|FG007|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063681|NCT01375777|FG008|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063682|NCT01375777|OG000|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11063683|NCT01375777|OG001|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11063684|NCT01375777|OG002|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
11063685|NCT01375777|OG003|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063686|NCT01375777|OG004|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063687|NCT01375777|OG005|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063688|NCT01375777|OG006|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063689|NCT01375777|OG007|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063690|NCT01375777|OG008|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063691|NCT01375777|EG000|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11063692|NCT01375777|EG001|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11063693|NCT01375777|EG002|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
11063694|NCT01375777|EG003|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063695|NCT01375777|EG004|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063696|NCT01375777|EG005|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11063697|NCT01375777|EG006|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063698|NCT01375777|EG007|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063699|NCT01375777|EG008|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11063700|NCT01375946|BG000|Baseline|AG200-15 Condition|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
11063701|NCT01375946|FG000|Participant Flow|AG200-15 Condition (NDC)|The subject will wear AG200-15 for 7 days and be exposed to normal (N), dry sauna (D) then cold water (C)conditions
11063702|NCT01375946|FG001|Participant Flow|AG200-15 Condition (CNW)|The subject will wear AG200-15 for 7 days and be exposed to cold water (C), normal (N) then whirlpool (W)conditions
11063703|NCT01375946|FG002|Participant Flow|AG200-15 Condition (WTN)|The subject will wear AG200-15 for 7 days and be exposed to whirlpool (W), treadmill (T) then normal (N)conditions
11063704|NCT01375946|FG003|Participant Flow|AG200-15 Condition (NCD)|The subject will wear AG200-15 for 7 days and be exposed to normal (N), cold water (C) then dry sauna (D)conditions
11063705|NCT01375946|FG004|Participant Flow|AG200-15 Condition (DNT)|The subject will wear AG200-15 for 7 days and be exposed to dry sauna (D), normal (N) then treadmill (T)conditions
11063706|NCT01375946|FG005|Participant Flow|AG200-15 Condition (TWN)|The subject will wear AG200-15 for 7 days and be exposed to treadmill (T), whirlpool (W) then normal (N) conditions
11063707|NCT01375946|OG000|Outcome|AG200-15 Condition|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
11063708|NCT01375946|EG000|Reported Event|AG200-15 Condition|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
11063709|NCT01376037|BG000|Baseline|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
11063710|NCT01376037|BG001|Baseline|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
11063711|NCT01376037|BG002|Baseline|Total|Total of all reporting groups
11063712|NCT01376037|FG000|Participant Flow|Erchonia ML Scanner (MLS)|The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17 milliWatts (mW) 635nm red laser light. The diodes are mounted in scanner devices positioned 120 degrees tileted from each other at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.
11063713|NCT01376037|FG001|Participant Flow|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
11063714|NCT01376037|OG000|Outcome|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
11063715|NCT01376037|OG001|Outcome|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
11063716|NCT01376037|EG000|Reported Event|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
11063717|NCT01376037|EG001|Reported Event|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
11063718|NCT01376050|BG000|Baseline|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
11063719|NCT01376050|BG001|Baseline|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
11063720|NCT01376050|BG002|Baseline|Total|Total of all reporting groups
11149523|NCT01871285|OG000|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
11063721|NCT01376050|FG000|Participant Flow|Erchonia ML Scanner (MLS)|Erchonia ML Scanner (MLS) comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light-emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
11063722|NCT01376050|FG001|Participant Flow|Placebo Laser|Placebo Laser has the same appearance and function as the Erchonia MLS but not does emit any therapeutic output.
11063723|NCT01376050|OG000|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
11063724|NCT01376050|OG001|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
11063725|NCT01376050|EG000|Reported Event|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
11063726|NCT01376050|EG001|Reported Event|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
11063727|NCT01376089|BG000|Baseline|Arm 1-Iodixanol|
11063728|NCT01376089|BG001|Baseline|Arm 2-Iopamidol|
11063729|NCT01376089|BG002|Baseline|Total|Total of all reporting groups
11063730|NCT01376089|FG000|Participant Flow|Arm 1-Iodixanol|Subjects were injected with Iodixanol (Visipaque).
11063731|NCT01376089|FG001|Participant Flow|Arm 2-Iopamidol|Subjects were injected with Iopamidol (Isovue).
11063732|NCT01376089|OG000|Outcome|Arm 1-Iodixanol (Visipaque)|Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.
11063733|NCT01376089|OG001|Outcome|Arm 2-Iopamidol (Isovue)|Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
11063734|NCT01376089|OG000|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
11063735|NCT01376089|OG001|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subjects injected with Isovue 370mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
11063736|NCT01376089|OG000|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
11063737|NCT01376089|OG001|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
11063738|NCT01376089|EG000|Reported Event|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
11063739|NCT01376089|EG001|Reported Event|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
11063740|NCT01376167|BG000|Baseline|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
11063741|NCT01376167|BG001|Baseline|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
11063742|NCT01376167|BG002|Baseline|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
11063743|NCT01376167|BG003|Baseline|Total|Total of all reporting groups
11063744|NCT01376167|FG000|Participant Flow|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
11063745|NCT01376167|FG001|Participant Flow|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
11063746|NCT01376167|FG002|Participant Flow|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
11063747|NCT01376167|OG000|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
11063748|NCT01376167|OG001|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
11063749|NCT01376167|OG002|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
11063750|NCT01376167|OG000|Outcome|First Malaria Recurrence|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) with a recurrence episode of malaria were included.
11063751|NCT01376167|OG001|Outcome|First Malaria Recurrence Follow-up|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) who had a follow-up visit for recurrence episode of malaria were included.
11063752|NCT01376167|OG000|Outcome|Participants in TQ Only Arms|TQ only arms
11063753|NCT01376167|EG000|Reported Event|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
11063754|NCT01376167|EG001|Reported Event|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
11063755|NCT01376167|EG002|Reported Event|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
11063756|NCT01376245|BG000|Baseline|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
11063757|NCT01376245|BG001|Baseline|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063758|NCT01376245|BG002|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063759|NCT01376245|BG003|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063760|NCT01376245|BG004|Baseline|Total|Total of all reporting groups
11063761|NCT01376245|FG000|Participant Flow|Placebo- Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
11063762|NCT01376245|FG001|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
11063763|NCT01376245|FG002|Participant Flow|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063764|NCT01376245|FG003|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063765|NCT01376245|FG004|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063766|NCT01376245|OG000|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
11063767|NCT01376245|OG001|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063768|NCT01376245|OG002|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063769|NCT01376245|OG003|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063770|NCT01376245|EG000|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
11063771|NCT01376245|EG001|Reported Event|FF/VI 50/25 µg OD|articipants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063772|NCT01376245|EG002|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063773|NCT01376245|EG003|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
11063774|NCT01376297|BG000|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
11063775|NCT01376297|BG001|Baseline|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
11063776|NCT01376297|BG002|Baseline|Total|Total of all reporting groups
11063777|NCT01376297|FG000|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
11063778|NCT01376297|FG001|Participant Flow|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
11063779|NCT01376297|OG000|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
11063780|NCT01376297|OG001|Outcome|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
11063781|NCT01376297|EG000|Reported Event|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
11063782|NCT01376297|EG001|Reported Event|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
11063783|NCT01376310|BG000|Baseline|Cohort A (GSK1120212 < 24 Weeks)|Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.
11063784|NCT01376310|BG001|Baseline|Cohort B (GSK1120212 >= 24 Weeks)|Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
11063785|NCT01376310|BG002|Baseline|Total|Total of all reporting groups
11063786|NCT01376310|FG000|Participant Flow|Cohort A (GSK1120212 < 24 Weeks)|Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.
11063787|NCT01376310|FG001|Participant Flow|Cohort B (GSK1120212 >= 24 Weeks)|Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
11063788|NCT01376310|OG000|Outcome|Cohort A (GSK1120212 < 24 Weeks)|Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.
11063789|NCT01376310|OG001|Outcome|Cohort B (GSK1120212 >= 24 Weeks)|Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
11063790|NCT01376310|EG000|Reported Event|Cohort A (GSK1120212 < 24 Weeks)|Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.
11063791|NCT01376310|EG001|Reported Event|Cohort B (GSK1120212 >= 24 Weeks)|Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
11063792|NCT01376349|BG000|Baseline|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
11063793|NCT01376349|BG001|Baseline|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
11063794|NCT01376349|BG002|Baseline|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. >~> There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
11063795|NCT01376349|BG003|Baseline|Total|Total of all reporting groups
11063796|NCT01376349|FG000|Participant Flow|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
11063797|NCT01376349|FG001|Participant Flow|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
11063798|NCT01376349|FG002|Participant Flow|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.~There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
11063799|NCT01376349|OG000|Outcome|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
11063800|NCT01376349|OG001|Outcome|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
11063801|NCT01376349|OG002|Outcome|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.~There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
11063802|NCT01376349|EG000|Reported Event|Arm I: Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
11063803|NCT01376349|EG001|Reported Event|Arm II: High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
11063804|NCT01376349|EG002|Reported Event|Arm III: Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.~There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
11063805|NCT01376349|EG003|Reported Event|Optional Continuation Phase|"Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study.~94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA."
11063806|NCT01376362|BG000|Baseline|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
11063807|NCT01376362|FG000|Participant Flow|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
11063808|NCT01376362|OG000|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
11063809|NCT01376362|EG000|Reported Event|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
11063810|NCT01376388|BG000|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
10848965|NCT00293033|EG000|Reported Event|Onsolis|All AEs were assigned to BEMA™ Fentanyl (Onsolis). Because of the multiple crossover design and the number of breakthrough pain episodes that usually occur during the day, it was likely that a subject would receive both active and placebo doses within a few hours of each other. Given the proximity of these different treatments, attempts to ascribe individual AEs to one treatment or another would be difficult, therefore, the chosen convention was to consider all AEs as occurring on active medication.
11063811|NCT01376388|FG000|Participant Flow|UMEC/VI 125/25 µg|Participants received GSK573719/GW642444 (UMEC/VI) 125/25 micrograms (µg) inhalation powder via a dry powder inhaler (DPI) once daily (OD) in the morning for 52 weeks.
11063812|NCT01376388|OG000|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
11063813|NCT01376388|EG000|Reported Event|GSK573719/GW642444|125/25mcg
11063814|NCT01376557|BG000|Baseline|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
11063815|NCT01376557|BG001|Baseline|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
11063816|NCT01376557|BG002|Baseline|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
10848966|NCT00293059|BG000|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
10848967|NCT00293059|BG001|Baseline|Placebo|Matching placebo to be taken orally daily
11063817|NCT01376557|BG003|Baseline|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
11063818|NCT01376557|BG004|Baseline|Placebo qd|Placebo: Subjects will receive placebo once daily.
11063819|NCT01376557|BG005|Baseline|Total|Total of all reporting groups
11063820|NCT01376557|FG000|Participant Flow|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
11063821|NCT01376557|FG001|Participant Flow|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
11063822|NCT01376557|FG002|Participant Flow|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
11063823|NCT01376557|FG003|Participant Flow|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
11063824|NCT01376557|FG004|Participant Flow|Placebo qd|Placebo: Subjects will receive placebo once daily.
11063825|NCT01376557|OG000|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
11063826|NCT01376557|OG001|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
10848968|NCT00293059|BG002|Baseline|Total|Total of all reporting groups
10848969|NCT00293059|FG000|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
10848970|NCT00293059|FG001|Participant Flow|Placebo|Matching placebo to be taken orally daily
10848971|NCT00293059|OG000|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
10848972|NCT00293059|OG001|Outcome|Placebo|Matching placebo to be taken orally daily
11063827|NCT01376557|OG002|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
11063828|NCT01376557|OG003|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
11063829|NCT01376557|OG004|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
11063830|NCT01376557|EG000|Reported Event|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
11063831|NCT01376557|EG001|Reported Event|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
11063832|NCT01376557|EG002|Reported Event|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
11063833|NCT01376557|EG003|Reported Event|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
11063834|NCT01376557|EG004|Reported Event|Placebo qd|Placebo: Subjects will receive placebo once daily.
11063835|NCT01376700|BG000|Baseline|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
10848973|NCT00293059|EG000|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
10848974|NCT00293059|EG001|Reported Event|Placebo|Matching placebo to be taken orally daily
11063836|NCT01376700|FG000|Participant Flow|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
11063837|NCT01376700|OG000|Outcome|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
11063838|NCT01376700|OG000|Outcome|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
11063839|NCT01376700|OG000|Outcome|PUPs|No previous FVIII exposure
11063840|NCT01376700|OG001|Outcome|MTPs|≤4 previous FVIII exposures
11063841|NCT01376700|EG000|Reported Event|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
11063842|NCT01376804|BG000|Baseline|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
11063843|NCT01376804|FG000|Participant Flow|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
11063844|NCT01376804|OG000|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
11063845|NCT01376804|EG000|Reported Event|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
11063846|NCT01376908|BG000|Baseline|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063847|NCT01376908|BG001|Baseline|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063848|NCT01376908|BG002|Baseline|Total|Total of all reporting groups
11063849|NCT01376908|FG000|Participant Flow|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063850|NCT01376908|FG001|Participant Flow|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063851|NCT01376908|OG000|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063852|NCT01376908|OG001|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063853|NCT01376908|OG000|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.After 26 weeks, the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
11063854|NCT01376908|OG001|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria. After 26 weeks, the starting dose of Kuvan will be 10 mg/kg/day, and the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
11063855|NCT01376908|OG000|Outcome|Pharmacogenetic Evaluation|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063856|NCT01376908|OG000|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063857|NCT01376908|OG000|Outcome|Population PK Analysis Set: Age Group 1 (< 1 Year)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063858|NCT01376908|OG001|Outcome|Population PK Analysis Set: Age Group 2 (1 to 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063859|NCT01376908|OG002|Outcome|Population PK Analysis Set: Age Group 2 (>= 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063860|NCT01376908|EG000|Reported Event|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
10848975|NCT00293202|BG000|Baseline|Etanercept|"Etanercept 25 mg injection twice a week~Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week"
11063861|NCT01376908|EG001|Reported Event|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
11063862|NCT01377012|BG000|Baseline|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
11063863|NCT01377012|BG001|Baseline|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
11063864|NCT01377012|BG002|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
11063865|NCT01377012|BG003|Baseline|Total|Total of all reporting groups
11063866|NCT01377012|FG000|Participant Flow|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks up to Week 100, then AIN457 150 mg s.c. starting at week 104
11063867|NCT01377012|FG001|Participant Flow|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
11063868|NCT01377012|FG002|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
11063869|NCT01377012|OG000|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
11063870|NCT01377012|OG001|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
11063871|NCT01377012|OG002|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
11063872|NCT01377012|EG000|Reported Event|Any AIN457 75 mg|Group contains all patients who received AIN 75mg during core period of the study. Includes : participants who were randomized to receive AIN457 i.v (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 75 mg at week 16 or week 24 of core study
11063873|NCT01377012|EG001|Reported Event|Any AIN457 150 mg|Group contains all patients from the core and the extension that ever received AIN 150mg. This includes : participants who were randomized to AIN457 150 mg arm to receive AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 150 mg at week 16 or week 24 + participants who completed core study in any arm and continued in the extension study to receive AIN457 150 mg as open-label study drug
11063874|NCT01377012|EG002|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16 of core. Responders were switched to active treatment in week 24 of core
11063875|NCT01377194|BG000|Baseline|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
11063876|NCT01377194|BG001|Baseline|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
11063877|NCT01377194|BG002|Baseline|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
11063878|NCT01377194|BG003|Baseline|Total|Total of all reporting groups
11063879|NCT01377194|FG000|Participant Flow|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
11063880|NCT01377194|FG001|Participant Flow|Levomilnacipran ER 40 mg|40mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
11063881|NCT01377194|FG002|Participant Flow|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
11063882|NCT01377194|OG000|Outcome|Placebo|Dose matched placebo oral administration in capsule form, once daily, for 8 weeks.
11063883|NCT01377194|OG001|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER oral administration in capsule form, once daily, for 8 weeks.
10848976|NCT00293202|BG001|Baseline|Placebo|"Saline injection twice a week~Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week"
11063884|NCT01377194|OG002|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER oral administration in capsule form, once daily for 8 weeks
11063885|NCT01377194|OG000|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
11063886|NCT01377194|OG001|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
11063887|NCT01377194|OG002|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
11063888|NCT01377194|EG000|Reported Event|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
11063889|NCT01377194|EG001|Reported Event|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
11063890|NCT01377194|EG002|Reported Event|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
11063891|NCT01377233|BG000|Baseline|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
11063892|NCT01377233|BG001|Baseline|Zicronapine 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
11063893|NCT01377233|BG002|Baseline|Zicronapine 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063894|NCT01377233|BG003|Baseline|Zicronapine 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063895|NCT01377233|BG004|Baseline|Zicronapine 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063896|NCT01377233|BG005|Baseline|Total|Total of all reporting groups
11063897|NCT01377233|FG000|Participant Flow|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
11063898|NCT01377233|FG001|Participant Flow|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
11063899|NCT01377233|FG002|Participant Flow|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063900|NCT01377233|FG003|Participant Flow|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063901|NCT01377233|FG004|Participant Flow|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063902|NCT01377233|OG000|Outcome|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
11063903|NCT01377233|OG001|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
11063904|NCT01377233|OG002|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063905|NCT01377233|OG003|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063906|NCT01377233|OG004|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063907|NCT01377233|OG000|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
11063908|NCT01377233|OG001|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063909|NCT01377233|OG002|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063910|NCT01377233|OG003|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063911|NCT01377233|EG000|Reported Event|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
11063912|NCT01377233|EG001|Reported Event|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
11063913|NCT01377233|EG002|Reported Event|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063914|NCT01377233|EG003|Reported Event|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063915|NCT01377233|EG004|Reported Event|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
11063916|NCT01377389|BG000|Baseline|Ipilimumab and Androgen Depravation|Participants with castrate sensitive prostate carcinoma
11063917|NCT01377389|FG000|Participant Flow|Ipilimumab and Androgen Depravation|Participants with castrate sensitive prostate carcinoma
11063918|NCT01377389|OG000|Outcome|Ipilimumab and Androgen Depravation|Participants with castrate sensitive prostate carcinoma
11063919|NCT01377389|EG000|Reported Event|Ipilimumab and Androgen Depravation|Participants with castrate sensitive prostate carcinoma
11063920|NCT01377402|BG000|Baseline|Patients With Suspected Acute Coronary Chest Pain|Patients recruited immediately following acute hospital admission for suspected coronary chest pain.
11063921|NCT01377402|FG000|Participant Flow|Patients With Suspected Acute Coronary Chest Pain|Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).
11063922|NCT01377402|OG000|Outcome|Patients With Suspected ACS|Patients with acute hospitalisation due to suspected coronary chest pain.
11063923|NCT01377402|OG000|Outcome|Cardiovascular Death|Patients with confirmed cardiovascular death during the course of the study
11063924|NCT01377402|OG001|Outcome|Myocardial Re-infarction|Patients with one or more myocardial re-infarctions during the course of the study
11063925|NCT01377402|EG000|Reported Event|Patients With Suspected ACS|Patients admitted to hospital with acute chest pain.
11063926|NCT01377467|BG000|Baseline|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
11063927|NCT01377467|BG001|Baseline|Control|No treatment
11063928|NCT01377467|BG002|Baseline|Total|Total of all reporting groups
11063929|NCT01377467|FG000|Participant Flow|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
11063930|NCT01377467|FG001|Participant Flow|Control|No treatment
11063931|NCT01377467|OG000|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
11063932|NCT01377467|OG001|Outcome|Control|No treatment
11063933|NCT01377467|EG000|Reported Event|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
11063934|NCT01377467|EG001|Reported Event|Control|No treatment
11063935|NCT01377480|BG000|Baseline|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
11063936|NCT01377480|BG001|Baseline|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
11063937|NCT01377480|BG002|Baseline|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
11063938|NCT01377480|BG003|Baseline|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
11063939|NCT01377480|BG004|Baseline|Total|Total of all reporting groups
11063940|NCT01377480|FG000|Participant Flow|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
11063941|NCT01377480|FG001|Participant Flow|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
11063942|NCT01377480|FG002|Participant Flow|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
11063943|NCT01377480|FG003|Participant Flow|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
11063944|NCT01377480|OG000|Outcome|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
11063945|NCT01377480|OG001|Outcome|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
11063946|NCT01377480|OG002|Outcome|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
11063947|NCT01377480|OG003|Outcome|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
11063948|NCT01377480|EG000|Reported Event|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
11063949|NCT01377480|EG001|Reported Event|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
11063950|NCT01377480|EG002|Reported Event|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
11063951|NCT01377480|EG003|Reported Event|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
11063952|NCT01377584|BG000|Baseline|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063953|NCT01377584|BG001|Baseline|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.
11063954|NCT01377584|BG002|Baseline|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063955|NCT01377584|BG003|Baseline|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
11063956|NCT01377584|BG004|Baseline|Patients in Usual Care|Patients will not attend any intervention sessions.
10848977|NCT00293202|BG002|Baseline|Total|Total of all reporting groups
11063957|NCT01377584|BG005|Baseline|Partners in Usual Care|Partners will not attend any intervention sessions
11063958|NCT01377584|BG006|Baseline|Total|Total of all reporting groups
11063959|NCT01377584|FG000|Participant Flow|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063960|NCT01377584|FG001|Participant Flow|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.
11063961|NCT01377584|FG002|Participant Flow|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063962|NCT01377584|FG003|Participant Flow|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
11063963|NCT01377584|FG004|Participant Flow|Patients in Usual Care|Patients will not attend any intervention sessions.
11063964|NCT01377584|FG005|Participant Flow|Partners in Usual Care|Partners will not attend any intervention sessions.
11063965|NCT01377584|OG000|Outcome|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063966|NCT01377584|OG001|Outcome|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.
11063967|NCT01377584|OG002|Outcome|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063968|NCT01377584|OG003|Outcome|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
11063969|NCT01377584|OG004|Outcome|Patients in Usual Care|Patients will not attend any intervention sessions.
11063970|NCT01377584|OG005|Outcome|Partners in Usual Care|Partners will not attend any intervention sessions.
11063971|NCT01377584|OG001|Outcome|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session
11063972|NCT01377584|OG001|Outcome|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063973|NCT01377584|OG002|Outcome|Patients in Usual Care|Patients will not attend any intervention sessions.
11063974|NCT01377584|EG000|Reported Event|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063975|NCT01377584|EG001|Reported Event|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session
11063976|NCT01377584|EG002|Reported Event|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
11063977|NCT01377584|EG003|Reported Event|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
11063978|NCT01377584|EG004|Reported Event|Patients in Usual Care|Patients will not attend any intervention sessions.
11063979|NCT01377584|EG005|Reported Event|Partners in Usual Care|Partners will not attend any intervention sessions.
11063980|NCT01377623|BG000|Baseline|Placebo Group|Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
11149524|NCT01871285|OG001|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
11063981|NCT01377623|BG001|Baseline|Dexmedetomidine Group|Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
11063982|NCT01377623|BG002|Baseline|Total|Total of all reporting groups
11063983|NCT01377623|FG000|Participant Flow|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
11063984|NCT01377623|FG001|Participant Flow|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
11063985|NCT01377623|OG000|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
11063986|NCT01377623|OG001|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
11063987|NCT01377623|EG000|Reported Event|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
11063988|NCT01377623|EG001|Reported Event|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
11063989|NCT01377636|BG000|Baseline|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
11063990|NCT01377636|FG000|Participant Flow|Pre and Post Isoproterenol Infusion|Bispectral EEG (BIS) monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
11063991|NCT01377636|OG000|Outcome|Pre and Post Isoproterenol Infusion|BIS monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
11063992|NCT01377636|OG000|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
11063993|NCT01377636|OG000|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
11063994|NCT01377636|EG000|Reported Event|Pre and Post Isoproterenol Infusion|In this study, serious adverse events were considered clinically significant adverse events. The well known isoproterenol effects on heart rate, rhythm, ST segments, and blood pressure were noted.
11063995|NCT01377844|BG000|Baseline|EGT0001442|EGT0001442 capsule, 20 mg, orally once daily
11063996|NCT01377844|BG001|Baseline|Placebo|Placebo capsule, 20 mg, orally once daily
11063997|NCT01377844|BG002|Baseline|Total|Total of all reporting groups
11063998|NCT01377844|FG000|Participant Flow|EGT0001442|EGT0001442 capsule, 20 mg, orally once daily
11063999|NCT01377844|FG001|Participant Flow|Placebo|Placebo capsule, orally once daily
11064000|NCT01377844|OG000|Outcome|EGT0001442|EGT0001442 capsule, 20 mg, orally once daily
11064001|NCT01377844|OG001|Outcome|Placebo|Placebo capsule, orally once daily
11064002|NCT01377844|OG001|Outcome|Placebo|Placebo capsule, 20 mg, orally once daily
11064003|NCT01377844|EG000|Reported Event|EGT0001442|EGT0001442 capsule, 20 mg, orally once daily
11064004|NCT01377844|EG001|Reported Event|Placebo|Placebo capsule, 20 mg, orally once daily
11064005|NCT01377922|BG000|Baseline|Part 2 and Part 3 Placebo|"Matching placebo tablets, administered 3-4 times a day for 2 weeks.~Placebo tablets indistinguishable from amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate."
11064006|NCT01377922|BG001|Baseline|Part 2 and Part 3 Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
11064007|NCT01377922|BG002|Baseline|Total|Total of all reporting groups
11064008|NCT01377922|FG000|Participant Flow|Part 2 and Part 3 Placebo|"Matching placebo tablets, administered 3-4 times a day for 2 weeks.~Placebo tablets indistinguishable from amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate."
11064009|NCT01377922|FG001|Participant Flow|Part 2 and Part 3 Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
11064010|NCT01377922|OG000|Outcome|Placebo|"Matching placebo tablets administered 3-4 times a day over 2 weeks.~Placebo: Matching number of tablets to the individual patient's tablet count of active at baseline."
11064011|NCT01377922|OG001|Outcome|Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
11064012|NCT01377922|EG000|Reported Event|Part 2 and Part 3 Placebo|"Matching placebo tablets, administered 3-4 times a day for 2 weeks.~Placebo tablets indistinguishable from amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate."
11064013|NCT01377922|EG001|Reported Event|Part 2 and Part 3 Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
11064014|NCT01377987|BG000|Baseline|All Patients|All patients randomized
11064015|NCT01377987|FG000|Participant Flow|Acetazolamide First, Then Placebo|"Acetazolamide: 4 mg/kg, once daily before bed, for 7 days~1 week washout Placebo: 4 mg/kg, once daily before bed, for 7 days"
11064016|NCT01377987|FG001|Participant Flow|Placebo First, Then Acetazolamide|"Placebo: 4 mg/kg, once daily before bed, for 7 days~1 week washout Acetazolamide: 4 mg/kg, once daily before bed, for 7 days"
11064017|NCT01377987|OG000|Outcome|Acetazolamide|Acetazolamide (active arm)
11064018|NCT01377987|OG001|Outcome|Placebo|Placebo arm
11064019|NCT01377987|EG000|Reported Event|Acetazolamide|Acetazolamide (active arm)
11064020|NCT01377987|EG001|Reported Event|Placebo|Placebo arm
11064021|NCT01378065|BG000|Baseline|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
11064022|NCT01378065|FG000|Participant Flow|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
11064023|NCT01378065|OG000|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
11064024|NCT01378065|EG000|Reported Event|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
11064025|NCT01378104|BG000|Baseline|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
11064026|NCT01378104|BG001|Baseline|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
11064027|NCT01378104|BG002|Baseline|Total|Total of all reporting groups
11064028|NCT01378104|FG000|Participant Flow|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
11064029|NCT01378104|FG001|Participant Flow|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
11064030|NCT01378104|OG000|Outcome|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
11064031|NCT01378104|OG001|Outcome|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
11064032|NCT01378104|OG000|Outcome|Favourable IL28B Genotype|These group patients show the IL28B rs12979860CC and rs8099917TT.
11064033|NCT01378104|OG001|Outcome|The Patients With Unfavourable IL28B Genotype|These group patients show the IL28B rs12979860 CT or TT and rs8099917 TG or GG.
11064034|NCT01378104|EG000|Reported Event|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
11064035|NCT01378104|EG001|Reported Event|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
11064036|NCT01378117|BG000|Baseline|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
11064037|NCT01378117|BG001|Baseline|Sitagliptin and Glargine + SSI|Sitagliptin 50-100 mg po once a day and subcutaneous glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI)
11064038|NCT01378117|BG002|Baseline|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blood glucose using sliding scale Insulin (SSI)
11064039|NCT01378117|BG003|Baseline|Total|Total of all reporting groups
11064040|NCT01378117|FG000|Participant Flow|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
11064041|NCT01378117|FG001|Participant Flow|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100 mg po once a day and Subcutaneous glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI)
11064042|NCT01378117|FG002|Participant Flow|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blood glucose using sliding scale Insulin (SSI)
11064043|NCT01378117|OG000|Outcome|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
11064044|NCT01378117|OG001|Outcome|Sitagliptin and Glargine + SSI|Sitagliptin 50-100 mg po once a day and subcutaneous glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI)
11064045|NCT01378117|OG002|Outcome|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blood glucose using sliding scale Insulin (SSI)
11064046|NCT01378117|OG000|Outcome|Sitagliptin + SSI Prn|"Sitagliptin once daily plus supplemental doses of lispro if needed.~Sitagliptin: Sitagliptin 50-100mg po once daily"
11064047|NCT01378117|OG001|Outcome|Sitagliptin and Glargine + SSI|"Sitagliptin 50-100 mg po once a day and subcutaneous (SQ) glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI)~glargine: glargine once daily"
11064048|NCT01378117|OG002|Outcome|Glargine and Lispro + SSI|"Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blood glucose using sliding scale Insulin (SSI)~lispro: lispro before meals"
11064049|NCT01378117|OG001|Outcome|Sitagliptin and Glargine + SSI|Sitagliptin 50-100 mg po once a day and SQ glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI)
11064050|NCT01378117|OG002|Outcome|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blo0d glucose using sliding scale Insulin (SSI)
11064051|NCT01378117|EG000|Reported Event|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
11064052|NCT01378117|EG001|Reported Event|Sitagliptin and Glargine + SSI|Sitagliptin 50-100 mg po once a day and SQ glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale Insulin (SSI)
11064053|NCT01378117|EG002|Reported Event|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blo0d glucose using sliding scale Insulin (SSI)
11064054|NCT01378195|BG000|Baseline|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
11064055|NCT01378195|BG001|Baseline|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
11064056|NCT01378195|BG002|Baseline|Total|Total of all reporting groups
11064057|NCT01378195|FG000|Participant Flow|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
11064058|NCT01378195|FG001|Participant Flow|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
11064059|NCT01378195|OG000|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
11064060|NCT01378195|OG001|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
11064061|NCT01378195|EG000|Reported Event|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
11064062|NCT01378195|EG001|Reported Event|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
11064063|NCT01378221|BG000|Baseline|Group 1|cardiac surgery patients age 65 years and less
11064064|NCT01378221|BG001|Baseline|Group 2|cardiac surgery patients aged 75 years and over
11064065|NCT01378221|BG002|Baseline|Total|Total of all reporting groups
11064066|NCT01378221|FG000|Participant Flow|Group 1|cardiac surgery patients age 65 years and less
11064067|NCT01378221|FG001|Participant Flow|Group 2|cardiac surgery patients aged 75 years and over
11064068|NCT01378221|OG000|Outcome|Group 1|cardiac surgery patients age 65 years and less
11064069|NCT01378221|OG001|Outcome|Group 2|cardiac surgery patients aged 75 years and over
11064070|NCT01378221|EG000|Reported Event|Group 1|cardiac surgery patients age 65 years and less
11064071|NCT01378221|EG001|Reported Event|Group 2|cardiac surgery patients aged 75 years and over
11064072|NCT01378273|BG000|Baseline|Control|Enrollment will occur within 24 hours of birth. Subjects will receive 6 doses of vehicle intravenously during the first 2 weeks of life. Doses will be administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections will be given three times a week through to 32-6/7 weeks postmenstrual age. Subjects are then followed until 22-26 months for neurodevelopmental testing.
11064073|NCT01378273|BG001|Baseline|Epo 1000 U/kg Followed by 400 U/kg|Enrollment will occur within 24 hours of birth. Epo 1000 U/kg/dose will be administered intravenously for the first 6 doses. Subjects in the Epo arm will then receive 400 U/kg/dose three times a week until they reach 32-6/7 weeks postmenstrual age. Subjects are then followed until 22-26 months for neurodevelopmental testing.
11064074|NCT01378273|BG002|Baseline|Total|Total of all reporting groups
11064075|NCT01378273|FG000|Participant Flow|Control|"Subjects will receive 6 doses of vehicle intravenously during the first 2 weeks of life. Doses will be administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections will be given three times a week through to 32-6/7 weeks postmenstrual age.~Control: Subjects will receive 6 doses of vehicle intravenously during the first 2 weeks of life. Doses will be administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections will be given three times a week through to 32-6/7 weeks postmenstrual age."
11064076|NCT01378273|FG001|Participant Flow|Epo 1000 U/kg Followed by 400 U/kg|"Subjects will receive 6 doses of intravenous Epo 1000 U/kg/dose at 48 hour intervals from the time of enrollment. Following the high dose period, subjects will receive subcutaneous Epo 400 U/kg/dose three times a week until 32-6/7 weeks postmenstrual age.~Epo: Enrollment will occur within 24 hours of birth. Study drug will be administered intravenously for the first 6 doses. Subjects in the Epo arm will then receive 400 U/kg/dose three times a week until they reach 32-6/7 weeks postmenstrual age. Control infants will receive sham injections."
11064077|NCT01378273|OG000|Outcome|Control|Subjects received 6 doses of vehicle intravenously during the first 2 weeks of life. Doses were administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections were given three times a week through to 32-6/7 weeks postmenstrual age.
11064078|NCT01378273|OG001|Outcome|Epo 1000 U/kg Followed by 400 U/kg|Subjects received 6 doses of intravenous Epo 1000 U/kg/dose at 48 hour intervals from the time of enrollment. Following the high dose period, subjects received subcutaneous Epo 400 U/kg/dose three times a week until 32-6/7 weeks postmenstrual age.
11064079|NCT01378273|OG000|Outcome|Control|Subjects received 6 doses of vehicle intravenously during the first 2 weeks of life. Doses were administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections were given three times a week through to 32-6/7 weeks postmenstrual age (PMA)
11064080|NCT01378273|OG001|Outcome|Epo 1000 U/kg Followed by 400 U/kg|Subjects received 6 doses of intravenous Epo 1000 U/kg/dose at 48 hour intervals from the time of enrollment. Following the high dose period, subjects received subcutaneous Epo 400 U/kg/dose three times a week until 32-6/7 weeks postmenstrual age (PMA).
11064081|NCT01378273|OG000|Outcome|Control|Subjects received 6 doses of vehicle intravenously during the first 2 weeks of life. Doses will be administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections were given three times a week through to 32-6/7 weeks postmenstrual age. Bayley scores of infant development were assessed at 22-26 months
11064082|NCT01378273|OG001|Outcome|Epo 1000 U/kg Followed by 400 U/kg|Enrollment occured within 24 hours of birth. Epo 1000 U/kg/dose was administered intravenously for the first 6 doses. Subjects then received 400 U/kg/dose three times a week until 32-6/7 weeks postmenstrual age. Bayley scores of infant development were assessed at 22-26 months
11064083|NCT01378273|EG000|Reported Event|Control|Subjects received 6 doses of vehicle intravenously during the first 2 weeks of life. Doses were administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections were given three times a week through to 32-6/7 weeks postmenstrual age (PMA)
11064084|NCT01378273|EG001|Reported Event|Epo 1000 U/kg Followed by 400 U/kg|Subjects received 6 doses of intravenous Epo 1000 U/kg/dose at 48 hour intervals from the time of enrollment. Following the high dose period, subjects received subcutaneous Epo 400 U/kg/dose three times a week until 32-6/7 weeks postmenstrual age (PMA).
11064085|NCT01378299|BG000|Baseline|Arm 1: Testosterone Cypionate|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different groups of BMI.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064086|NCT01378299|FG000|Participant Flow|Arm 1: Testosterone Cypionate|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different groups of BMI.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-, (178)-. Its molecular formula is CvH400a, and the molecular weight 412.61.is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate."
11064087|NCT01378299|OG000|Outcome|GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064088|NCT01378299|OG001|Outcome|GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene."
11064089|NCT01378299|OG002|Outcome|AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene."
11064090|NCT01378299|OG000|Outcome|GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different genotypes of the rs1062033 polymorphism in the CYP19A1 gene~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064091|NCT01378299|OG001|Outcome|GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different genotypes of the rs1062033 polymorphism in the CYP19A1 gene"
11064092|NCT01378299|OG002|Outcome|CC Genotype for the rs1062033|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different genotypes of the rs1062033 polymorphism in the CYP19A1 gene"
11066948|NCT01394276|OG000|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
11064093|NCT01378299|OG000|Outcome|BMI Group 1|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different groups of BMI.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064094|NCT01378299|OG001|Outcome|BMI Group 2|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different groups of BMI."
11064095|NCT01378299|OG002|Outcome|BMI Group 3|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different groups of BMI."
11064096|NCT01378299|OG000|Outcome|GG Genotype for the rs700518 Polymor[Hism of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different genotypes for the rs700518 polymorphism of the CYP19A1 gene~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064097|NCT01378299|OG001|Outcome|GA Genotype of the rs700518 Polymorphism in CYP19A1 Gen|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different genotypes for the rs700518 polymorphism of the CYP19A1 gene"
11064098|NCT01378299|OG002|Outcome|AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different genotypes for the rs700518 polymorphism of the CYP19A1 gene"
11064099|NCT01378299|OG002|Outcome|CC Genotype for the rs1062033 Polymorphism in the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different genotypes of the rs1062033 polymorphism in the CYP19A1 gene"
11064100|NCT01378299|OG000|Outcome|GG Genotype for the rs700518 Polymorphism of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided according to the genotypes of rs700718 polymorphism of the CYP19A1 gene.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064101|NCT01378299|OG001|Outcome|GA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided according to the genotypes of rs700718 polymorphism of the CYP19A1 gene."
11064102|NCT01378299|OG002|Outcome|AA Genotype for the rs700518 Polymorphism of the|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided according to the genotypes of rs700718 polymorphism of the CYP19A1 gene."
11064103|NCT01378299|OG002|Outcome|CC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into different genotypes of the rs1062033 polymorphism in the CYP19A1 gene."
11064104|NCT01378299|OG000|Outcome|GG Genotype for the rs700518 Polymorphism in the cYP19A1 Gene|
11064105|NCT01378299|OG001|Outcome|GA Genoypr for the rs700518 Polymorphism of the CYP19A1 Gene|
11064106|NCT01378299|OG002|Outcome|AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene|
11064107|NCT01378299|OG000|Outcome|GG Genotype for RS 700518 of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064108|NCT01378299|OG001|Outcome|GA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene."
11064109|NCT01378299|OG000|Outcome|GG Genotype for the rs1062033 Polymorphism of the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided according to the genotypes of rs1062033 polymorphism of the CYP19A1 gene.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064110|NCT01378299|OG001|Outcome|GC Genotype for the rs1062033 Polymorphism of the|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided according to the genotypes of 1062033 polymorphism of the CYP19A1 gene."
11064111|NCT01378299|OG002|Outcome|GG Genotype for the rs1062033 Polymorphism in the CYP19A1 Gene|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided according to the genotypes of 1062033 polymorphism of the CYP19A1 gene."
11064112|NCT01378299|OG000|Outcome|Subjects With Diabetes Mellitus|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into those with and without diabetes mellitus.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064113|NCT01378299|OG001|Outcome|Subjects Without Diabetes Mellitus|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Subjects were divided into those with and without diabetes mellitus."
11064114|NCT01378299|EG000|Reported Event|Arm 1: Testosterone Cypionate|"All patients who qualify for the study will receive testosterone cypionate~Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,~(178)-. Its molecular formula is CvH400a, and the mole"
11064115|NCT01378325|BG000|Baseline|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
11064116|NCT01378325|BG001|Baseline|Phenylephrine|PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
11064117|NCT01378325|BG002|Baseline|Total|Total of all reporting groups
11064118|NCT01378325|FG000|Participant Flow|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery~Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
11064119|NCT01378325|FG001|Participant Flow|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
11064120|NCT01378325|OG000|Outcome|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery~Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
11064121|NCT01378325|OG001|Outcome|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
11064122|NCT01378325|EG000|Reported Event|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
11064123|NCT01378325|EG001|Reported Event|Phenylephrine|Phenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
11064124|NCT01378377|BG000|Baseline|Pimasertib 45 mg+Temsirolimus 12.5 mg|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 12.5 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064125|NCT01378377|BG001|Baseline|Pimasertib 45 mg+Temsirolimus 25 mg|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11149525|NCT01871285|OG002|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
11064126|NCT01378377|BG002|Baseline|Pimasertib 75 mg+Temsirolimus 25 mg|Pimasertib was administered in fasted state at a dose of 75 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064127|NCT01378377|BG003|Baseline|Total|Total of all reporting groups
11064128|NCT01378377|FG000|Participant Flow|Pimasertib 45 mg+Temsirolimus 12.5 mg|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 12.5 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064129|NCT01378377|FG001|Participant Flow|Pimasertib 45 mg+Temsirolimus 25 mg|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064130|NCT01378377|FG002|Participant Flow|Pimasertib 75 mg+Temsirolimus 25 mg|Pimasertib was administered in fasted state at a dose of 75 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064131|NCT01378377|OG000|Outcome|Pimasertib 45 mg+Temsirolimus 12.5 mg|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 12.5 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064132|NCT01378377|OG001|Outcome|Pimasertib 45 mg+Temsirolimus 25 mg|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064133|NCT01378377|OG002|Outcome|Pimasertib 75 mg+Temsirolimus 25 mg|Pimasertib was administered in fasted state at a dose of 75 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064134|NCT01378377|OG000|Outcome|Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI)|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 12.5 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent. Subjects were analyzed for drug-drug interaction.
11064135|NCT01378377|OG001|Outcome|Pimasertib 45 mg+Temsirolimus 25 mg (DDI)|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent. Subjects were analyzed for drug-drug interaction.
11064136|NCT01378377|OG002|Outcome|Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI)|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent. Subjects were not analyzed for drug-drug interaction.
11064137|NCT01378377|OG003|Outcome|Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI)|Pimasertib was administered in fasted state at a dose of 75 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent. Subjects were not analyzed for drug-drug interaction.
11064138|NCT01378377|OG003|Outcome|Pimasertib 75 mg+Temsirolimus (TEM) 25 mg (Non-DDI)|Pimasertib was administered in fasted state at a dose of 75 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent. Subjects were not analyzed for drug-drug interaction.
11064139|NCT01378377|EG000|Reported Event|Pimasertib 45 mg+Temsirolimus 12.5 mg|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 12.5 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064140|NCT01378377|EG001|Reported Event|Pimasertib 45 mg+Temsirolimus 25 mg|Pimasertib was administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064141|NCT01378377|EG002|Reported Event|Pimasertib 75 mg+Temsirolimus 25 mg|Pimasertib was administered in fasted state at a dose of 75 mg once daily orally on Days 1 to 15. Temsirolimus was administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment was continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
11064142|NCT01378416|BG000|Baseline|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
11064143|NCT01378416|FG000|Participant Flow|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
11064144|NCT01378416|OG000|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
11064145|NCT01378416|EG000|Reported Event|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
11064146|NCT01378429|BG000|Baseline|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
11064147|NCT01378429|BG001|Baseline|Ciclesonide Nasal Aerosol (74 mcg)|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
11064148|NCT01378429|BG002|Baseline|Total|Total of all reporting groups
11064149|NCT01378429|FG000|Participant Flow|Placebo|Placebo: Placebo
11064150|NCT01378429|FG001|Participant Flow|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)~ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
11064151|NCT01378429|OG000|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
11064152|NCT01378429|OG001|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
11064153|NCT01378429|OG000|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
11064154|NCT01378429|OG001|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
11064155|NCT01378429|OG000|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
11064156|NCT01378429|EG000|Reported Event|Placebo|Placebo: Placebo
11064157|NCT01378429|EG001|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)~ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
11064158|NCT01378520|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Ketoconazole first and inert powder first.
11064159|NCT01378520|FG000|Participant Flow|First Ketoconazole, Then Inert Powder|Ketoconzaole (600 mg taken orally) in first intervention period and inert powder (in capsule taken orally) in second intervention period.
11064160|NCT01378520|FG001|Participant Flow|First Inert Powder, Then Ketoconazole|Inert powder (in capsule taken orally) in first intervention period and Ketoconzaole (600 mg taken orally) in second intervention period.
11064161|NCT01378520|OG000|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
11064162|NCT01378520|OG001|Outcome|Inert Powder|Inert powder (in capsule taken orally)
11064163|NCT01378520|EG000|Reported Event|Ketoconazole|Ketoconazole(600 mg taken orally)
11064164|NCT01378520|EG001|Reported Event|Inert Powder|Inert powder (in capsule taken orally)
11064165|NCT01378858|BG000|Baseline|Varenicline Treatment as Usual (TAU)|"Subjects in the TAU arm will self administer varenicline for 12 weeks.~Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks."
11064166|NCT01378858|BG001|Baseline|Varenicline Directly Observed Therapy|"Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.~Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks."
11064167|NCT01378858|BG002|Baseline|Total|Total of all reporting groups
11064168|NCT01378858|FG000|Participant Flow|Varenicline Treatment as Usual (TAU)|"Subjects in the TAU arm will self administer varenicline for 12 weeks.~Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks."
11064169|NCT01378858|FG001|Participant Flow|Varenicline Directly Observed Therapy|"Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.~Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks."
11064170|NCT01378858|OG000|Outcome|Varenicline Treatment as Usual (TAU)|"Subjects in the TAU arm will self administer varenicline for 12 weeks.~Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks."
11064171|NCT01378858|OG001|Outcome|Varenicline Directly Observed Therapy|"Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.~Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks."
11064172|NCT01378858|EG000|Reported Event|Varenicline Treatment as Usual (TAU)|"Subjects in the TAU arm will self administer varenicline for 12 weeks.~Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks."
11064173|NCT01378858|EG001|Reported Event|Varenicline Directly Observed Therapy|"Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.~Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks."
11064174|NCT01378962|BG000|Baseline|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
11064175|NCT01378962|FG000|Participant Flow|Erlotinib 150 mg|Erlotinib 150 milligrams (mg) tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
11064176|NCT01378962|OG000|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
11064177|NCT01378962|EG000|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
11064178|NCT01378975|BG000|Baseline|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064179|NCT01378975|BG001|Baseline|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064180|NCT01378975|BG002|Baseline|Total|Total of all reporting groups
11064181|NCT01378975|FG000|Participant Flow|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064182|NCT01378975|FG001|Participant Flow|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064183|NCT01378975|OG000|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064184|NCT01378975|OG001|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064185|NCT01378975|OG000|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064186|NCT01378975|EG000|Reported Event|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064187|NCT01378975|EG001|Reported Event|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
11064188|NCT01378988|BG000|Baseline|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
11064189|NCT01378988|BG001|Baseline|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
11064190|NCT01378988|BG002|Baseline|Total|Total of all reporting groups
11064191|NCT01378988|FG000|Participant Flow|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
11064192|NCT01378988|FG001|Participant Flow|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
11064193|NCT01378988|OG000|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
11064194|NCT01378988|OG001|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
11064195|NCT01378988|EG000|Reported Event|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance dose
11064196|NCT01378988|EG001|Reported Event|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance dose
11064197|NCT01379183|BG000|Baseline|Erythromycin|Erythromycin 200 mg i.v. suspension
11064198|NCT01379183|BG001|Baseline|Placebo|Matching placebo i.v. suspension
11064199|NCT01379183|BG002|Baseline|Total|Total of all reporting groups
11064200|NCT01379183|FG000|Participant Flow|Erythromycin|Erythromycin 200 mg i.v. suspension
11064201|NCT01379183|FG001|Participant Flow|Placebo|Matching placebo i.v. suspension
11064202|NCT01379183|OG000|Outcome|Erythromycin|Erythromycin 200 mg i.v. suspension
11064203|NCT01379183|OG001|Outcome|Placebo|Matching placebo i.v. suspension
11064204|NCT01379183|OG000|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
11064205|NCT01379183|OG001|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
11064206|NCT01379183|EG000|Reported Event|Erythromycin|Erythromycin 200 mg i.v. suspension
11064207|NCT01379183|EG001|Reported Event|Placebo|Matching placebo i.v. suspension
11064208|NCT01379222|BG000|Baseline|ENGAGE PAS De Novo Subjects|"The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).~>~> Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure."
11064209|NCT01379222|FG000|Participant Flow|ENGAGE PAS De Novo Subjects|"The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).~>~> Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure."
11064210|NCT01379222|OG000|Outcome|ENGAGE PAS De Novo Subjects|"The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).~>~> Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure."
11064211|NCT01379222|EG000|Reported Event|1. Engage PAS|Medtronic Engage PAS De Novo Subjects
11064212|NCT01379508|BG000|Baseline|LdT Mono at Week 24|Patients who had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 continued to receive 600 mg telbivudine daily after Week 24
11064213|NCT01379508|BG001|Baseline|LdT+TDF at Week 24|Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24.
11064214|NCT01379508|BG002|Baseline|TDF Mono at Week 24|Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24.
11064215|NCT01379508|BG003|Baseline|TDF + LdT at Week 24|Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24.
11064216|NCT01379508|BG004|Baseline|Total|Total of all reporting groups
11064217|NCT01379508|FG000|Participant Flow|LdT Mono at Week 24|Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily after Week 24
11064218|NCT01379508|FG001|Participant Flow|LdT+TDF at Week 24|Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24.
11064219|NCT01379508|FG002|Participant Flow|TDF Mono at Week 24|Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24.
11064220|NCT01379508|FG003|Participant Flow|TDF + LdT at Week 24|Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24.
11064221|NCT01379508|OG000|Outcome|LdT Overall|Ldt Mono and LdT + TDF combined
11064222|NCT01379508|OG001|Outcome|TDF Overall|TDF mono and TDF + LdT combined
11064223|NCT01379508|OG000|Outcome|LdT Mono at Week 24|Patients who had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 continued to receive 600 mg telbivudine daily after Week 24
11064224|NCT01379508|OG001|Outcome|LdT+TDF at Week 24|Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24.
11064225|NCT01379508|OG002|Outcome|LdT Overall|Ldt Mono and LdT + TDF combined
11064226|NCT01379508|OG003|Outcome|TDF Mono at Week 24|Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24.
11064227|NCT01379508|OG004|Outcome|TDF + LdT at Week 24|Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24.
11064228|NCT01379508|OG005|Outcome|TDF Overall|TDF mono and TDF + LdT combined
11064229|NCT01379508|EG000|Reported Event|LdT Mono at Week 24|LdT Mono at Week 24
11064230|NCT01379508|EG001|Reported Event|LdT + TDF at Week 24|LdT + TDF at Week 24
11064231|NCT01379508|EG002|Reported Event|TDF Mono at Week 24|TDF Mono at Week 24
11064232|NCT01379508|EG003|Reported Event|TDF + LdT at Week 24|TDF + LdT at Week 24
11064233|NCT01379521|BG000|Baseline|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
11064234|NCT01379521|BG001|Baseline|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
11064235|NCT01379521|BG002|Baseline|Total|Total of all reporting groups
11064236|NCT01379521|FG000|Participant Flow|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
11064237|NCT01379521|FG001|Participant Flow|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
11064238|NCT01379521|OG000|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
11064239|NCT01379521|OG001|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
11064240|NCT01379521|EG000|Reported Event|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
11064241|NCT01379521|EG001|Reported Event|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
11064242|NCT01379534|BG000|Baseline|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
11064243|NCT01379534|BG001|Baseline|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
11064244|NCT01379534|BG002|Baseline|Total|Total of all reporting groups
11064245|NCT01379534|FG000|Participant Flow|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
11064246|NCT01379534|FG001|Participant Flow|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
11064247|NCT01379534|OG000|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
11064248|NCT01379534|OG001|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
11064249|NCT01379534|EG000|Reported Event|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
11064250|NCT01379534|EG001|Reported Event|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
11064251|NCT01379573|BG000|Baseline|Pregnant Women With Previous Child With Cardiac Neonatal Lupus|"400 mg/day Hydroxychloroquine~Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills."
11064252|NCT01379573|FG000|Participant Flow|Pregnant Women With Previous Child With Cardiac Neonatal Lupus|"400 mg/day Hydroxychloroquine~Hydroxychloroquine: women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills."
11064253|NCT01379573|OG000|Outcome|Pregnant Women With Previous Child With Cardiac Neonatal Lupus|"400 mg/day Hydroxychloroquine~Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills."
11064254|NCT01379573|EG000|Reported Event|Pregnant Women With Previous Child With Cardiac Neonatal Lupus|"400 mg/day Hydroxychloroquine~Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills."
11064255|NCT01379625|BG000|Baseline|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
11064256|NCT01379625|BG001|Baseline|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
11064257|NCT01379625|BG002|Baseline|Total|Total of all reporting groups
11064258|NCT01379625|FG000|Participant Flow|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
11064259|NCT01379625|FG001|Participant Flow|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
11064260|NCT01379625|OG000|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
11064261|NCT01379625|OG001|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
11064262|NCT01379625|EG000|Reported Event|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
11064263|NCT01379625|EG001|Reported Event|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
11064264|NCT01379651|BG000|Baseline|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
11064265|NCT01379651|BG001|Baseline|Control|controls were kept on an egg-free diet for 6 months
11064266|NCT01379651|BG002|Baseline|Total|Total of all reporting groups
11064267|NCT01379651|FG000|Participant Flow|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
11064268|NCT01379651|FG001|Participant Flow|Control|controls were kept on an egg-free diet for 6 months
11064269|NCT01379651|OG000|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
11064270|NCT01379651|OG001|Outcome|Control|controls were kept on an egg-free diet for 6 months
11064271|NCT01379651|EG000|Reported Event|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
11064272|NCT01379651|EG001|Reported Event|Control|controls were kept on an egg-free diet for 6 months
11064273|NCT01379664|BG000|Baseline|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
11064274|NCT01379664|BG001|Baseline|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
11064275|NCT01379664|BG002|Baseline|Total|Total of all reporting groups
11064276|NCT01379664|FG000|Participant Flow|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
11064277|NCT01379664|FG001|Participant Flow|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
11064278|NCT01379664|OG000|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
11064279|NCT01379664|OG001|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
11064280|NCT01379664|EG000|Reported Event|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
11064281|NCT01379664|EG001|Reported Event|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
11064282|NCT01379703|BG000|Baseline|Total Study Population|HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.
11064283|NCT01379703|FG000|Participant Flow|Tablets and Capsules or Oral Solution|HIV-1 infected participants who received both tablet and capsule formulations or oral solution.
11064284|NCT01379703|FG001|Participant Flow|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
11064285|NCT01379703|FG002|Participant Flow|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
11064286|NCT01379703|OG000|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
11064287|NCT01379703|OG001|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
11064288|NCT01379703|OG002|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
11064289|NCT01379703|OG000|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
11064290|NCT01379703|EG000|Reported Event|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
11064291|NCT01379703|EG001|Reported Event|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
11064292|NCT01379703|EG002|Reported Event|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
11064293|NCT01379768|BG000|Baseline|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
11064294|NCT01379768|BG001|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
11064295|NCT01379768|BG002|Baseline|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
11064296|NCT01379768|BG003|Baseline|Total|Total of all reporting groups
11064297|NCT01379768|FG000|Participant Flow|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
11064298|NCT01379768|FG001|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
11064299|NCT01379768|FG002|Participant Flow|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
11064300|NCT01379768|OG000|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
11064301|NCT01379768|OG001|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
11064302|NCT01379768|OG002|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
11064303|NCT01379768|EG000|Reported Event|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
11064304|NCT01379768|EG001|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
11064305|NCT01379768|EG002|Reported Event|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
11064306|NCT01379924|BG000|Baseline|Young Parents Program Plus Parenting/Life Skills Modules|Patient takes part in modules that were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers. The Nurturing Curriculum has been shown in our past program to be associated with increased parenting skills, maternal self-esteem and decreased life hassles. This curriculum is integrated with the Ansell-Casey life skills Curriculum and The Women's Negotiation Project Curriculum to help teen mothers develop the skills and communication needs of daily living. The series of five, one-hour long, structured, one-on-one interactive modules aims to help teens build positive, empathetic relationships with their children, while enhancing self-efficacy and increasing the sense of self- worth for parents and children. Domains addressed include child development/discipline, safety, house/money management, social relationships, career planning, substance abuse and community and interpersonal violence.
11064307|NCT01379924|BG001|Baseline|Young Parents Program Usual Care|Those in the control group receive the YPP standard of care including comprehensive multi-disciplinary team medical and mental health support and toddler educational family forums during year 2. No intervention.
11064308|NCT01379924|BG002|Baseline|Total|Total of all reporting groups
11064309|NCT01379924|FG000|Participant Flow|Young Parents Program Plus Parenting/Life Skills Modules|These modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers. The Nurturing Curriculum has been shown in our past program to be associated with increased parenting skills, maternal self-esteem and decreased life hassles. The nationally recognized Nurturing Curriculum is integrated with the Ansell-Casey life skills Curriculum and The Women's Negotiation Project Curriculum to help teen mothers develop the skills and communication needs of daily living. The series of five, one-hour long, structured, one-on-one interactive modules aims to help teens build positive, empathetic relationships with their children, while enhancing self-efficacy and increasing the sense of self- worth for parents and children. Domains addressed include child development/discipline, safety, house/money management, social relationships, career planning, substance abuse and community and interpersonal violence.
11064310|NCT01379924|FG001|Participant Flow|Young Parents Program Usual Care|"Patients receive regular standard of care without modules.~No intervention"
11064311|NCT01379924|OG000|Outcome|Young Parents Program Plus Parenting/Life Skills Modules|Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. The series of five, one-hour long, structured, one-on-one interactive modules aims to help teens build positive, empathetic relationships with their children, while enhancing self-efficacy and increasing the sense of self- worth for parents and children. Domains addressed include child development/discipline, safety, house/money management, social relationships, career planning, substance abuse and community and interpersonal violence. Family planning is discussed at each session.
11064312|NCT01379924|OG001|Outcome|Young Parents Program Usual Care|"Patients receive regular standard of care without parenting/life skills intervention.~No intervention"
11064313|NCT01379924|OG000|Outcome|Young Parents Program Plus Parenting/Life Skills Modules|Modules: These modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers. The Nurturing Curriculum has been shown in our past program to be associated with increased parenting skills, maternal self-esteem and decreased life hassles. The nationally recognized Nurturing Curriculum is integrated with the Ansell-Casey life skills Curriculum and The Women's Negotiation Project Curriculum to help teen mothers develop the skills and communication needs of daily living. The series of five, one-hour long, structured, one-on-one interactive modules aims to help teens build positive, empathetic relationships with their children, while enhancing self-efficacy and increasing the sense of self- worth for parents and children. Domains addressed include child development/discipline, safety, house/money management, social relationships, career planning, substance abuse and community and interpersonal violence.
11064314|NCT01379924|OG001|Outcome|Young Parents Program Usual Care|"Patients receive regular standard of care without modules.~No intervention"
11064315|NCT01379924|EG000|Reported Event|Non Randomized|"These are those mothers in the group who choose not to be randomized into the study, or the fathers who participate who are not randomized into the study.~No intervention: Those in the control group receive the YPP standard of care including comprehensive multi-disciplinary team medical and mental health support and toddler educational family forums during year 2."
11064316|NCT01379924|EG001|Reported Event|Modules|These modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers. The Nurturing Curriculum has been shown in our past program to be associated with increased parenting skills, maternal self-esteem and decreased life hassles. The nationally recognized Nurturing Curriculum is integrated with the Ansell-Casey life skills Curriculum and The Women's Negotiation Project Curriculum to help teen mothers develop the skills and communication needs of daily living. The series of five, one-hour long, structured, one-on-one interactive modules aims to help teens build positive, empathetic relationships with their children, while enhancing self-efficacy and increasing the sense of self- worth for parents and children. Domains addressed include child development/discipline, safety, house/money management, social relationships, career planning, substance abuse and community and interpersonal violence.
11064317|NCT01379924|EG002|Reported Event|Control|"Patients receive regular standard of care without modules.~No intervention"
11064318|NCT01379937|BG000|Baseline|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064319|NCT01379937|BG001|Baseline|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064320|NCT01379937|BG002|Baseline|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064321|NCT01379937|BG003|Baseline|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064322|NCT01379937|BG004|Baseline|Total|Total of all reporting groups
11064323|NCT01379937|FG000|Participant Flow|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064324|NCT01379937|FG001|Participant Flow|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064325|NCT01379937|FG002|Participant Flow|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064326|NCT01379937|FG003|Participant Flow|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064327|NCT01379937|OG000|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064328|NCT01379937|OG001|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064329|NCT01379937|OG000|Outcome|GSK1562902A Formulation 1 & 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, no or 1 booster dose of vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 or 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064330|NCT01379937|OG001|Outcome|GSK1562902A Formulation 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received no or 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064331|NCT01379937|OG001|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064332|NCT01379937|OG002|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064333|NCT01379937|OG003|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064334|NCT01379937|OG003|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
11064335|NCT01379937|OG000|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
11064336|NCT01379937|EG000|Reported Event|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064337|NCT01379937|EG001|Reported Event|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064338|NCT01379937|EG002|Reported Event|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064339|NCT01379937|EG003|Reported Event|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
11064340|NCT01379963|BG000|Baseline|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
11064341|NCT01379963|FG000|Participant Flow|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
11064342|NCT01379963|OG000|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
11064343|NCT01379963|EG000|Reported Event|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
11064344|NCT01380080|BG000|Baseline|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
11064345|NCT01380080|BG001|Baseline|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
11064346|NCT01380080|BG002|Baseline|Total|Total of all reporting groups
11064347|NCT01380080|FG000|Participant Flow|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
11064348|NCT01380080|FG001|Participant Flow|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
11064349|NCT01380080|OG000|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
11064350|NCT01380080|OG001|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
11064351|NCT01380080|EG000|Reported Event|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
11149526|NCT01871285|OG003|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
11064352|NCT01380080|EG001|Reported Event|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
11064353|NCT01380093|BG000|Baseline|Entire Study Population|Includes all participants enrolled in the study.
11064354|NCT01380093|FG000|Participant Flow|Naloxone|Naloxone hydrochloride 0.2 milligram (mg) intravenously (IV) followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal. Participants in this group were assigned to either morphine then placebo or placebo then morphine in the drug discrimination phase of the study.
11064355|NCT01380093|FG001|Participant Flow|Morphine Then Placebo|Single dose of morphine sulfate 120 mg solution orally on Day 1 followed by single dose of matching placebo solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
11064356|NCT01380093|FG002|Participant Flow|Placebo Then Morphine|Single dose of matching placebo solution orally on Day 1 followed by single dose of morphine sulfate 120 mg solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
11064357|NCT01380093|FG003|Participant Flow|Placebo Then EMBEDA Then Morphine|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of EMBEDA extended release (ER) capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) controlled release (CR) tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
11064358|NCT01380093|FG004|Participant Flow|EMBEDA Then Morphine Then Placebo|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
11064359|NCT01380093|FG005|Participant Flow|Morphine Then Placebo Then EMBEDA|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
11064360|NCT01380093|FG006|Participant Flow|Morphine Then EMBEDA Then Placebo|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
11064361|NCT01380093|FG007|Participant Flow|Placebo Then Morphine Then EMBEDA|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
11064362|NCT01380093|FG008|Participant Flow|EMBEDA Then Placebo Then Morphine|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
11064363|NCT01380093|OG000|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
11064364|NCT01380093|OG001|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
11064365|NCT01380093|OG002|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
11064366|NCT01380093|OG001|Outcome|EMBEDA|Single dose of EMBEDA solution containing 120 mg morphine sulfate / 4.8 mg naltrexone hydrochloride administered orally in either of the first to third intervention periods.
11064367|NCT01380093|OG000|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
11064368|NCT01380093|OG001|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
11064369|NCT01380093|EG000|Reported Event|Naloxone (Naloxone Challenge Phase)|Naloxone hydrochloride 0.2 mg IV followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal.
11064370|NCT01380093|EG001|Reported Event|Placebo (Drug Discrimination Phase)|Single dose of matching placebo solution orally on Day 1 or 2.
11064371|NCT01380093|EG002|Reported Event|Morphine (Drug Discrimination Phase)|Single dose of morphine sulfate 120 mg solution orally on Day 1 or 2.
11064372|NCT01380093|EG003|Reported Event|Placebo (Treatment Phase)|Single dose of matching placebo solution orally in either of the first to third intervention periods.
11064373|NCT01380093|EG004|Reported Event|EMBEDA (Treatment Phase)|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
11064374|NCT01380093|EG005|Reported Event|Morphine (Treatment Phase)|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
11064375|NCT01380106|BG000|Baseline|Lenalidomide 25mg|"Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle~Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle"
11064376|NCT01380106|BG001|Baseline|Lenalidomide 15mg|"Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle~Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle."
11064377|NCT01380106|BG002|Baseline|Total|Total of all reporting groups
11064378|NCT01380106|FG000|Participant Flow|Lenalidomide 25mg|Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle
11064379|NCT01380106|FG001|Participant Flow|Lenalidomide 15mg|Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
11064380|NCT01380106|OG000|Outcome|Lenalidomide 25mg|"Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle~Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle"
11064381|NCT01380106|OG001|Outcome|Lenalidomide 15mg|"Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle~Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle."
11064382|NCT01380106|EG000|Reported Event|Lenalidomide 25mg|"Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle~Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle"
11064383|NCT01380106|EG001|Reported Event|Lenalidomide 15mg|"Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle~Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle."
11064384|NCT01380145|BG000|Baseline|All Enrolled Subjects|Includes all subjects enrolled in the study.
11064385|NCT01380145|FG000|Participant Flow|All Enrolled Subjects|Subjects received a total of 8 pre- and post-auto-SCT immunizations with recMAGE-A3 + AS15 administered intramuscularly at a dose of 300 µg recMAGE-A3, with no dose adjustments permitted. The first immunization was administered 6 to 15 week prior to auto-SCT, with subsequent immunizations administered on Days 10, 31, 52, 73, and 94 (± 3 days) and Days 180 and 270 (± 7 days) after auto-SCT.
11064386|NCT01380145|OG000|Outcome|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
11064387|NCT01380145|OG000|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
11064388|NCT01380145|OG000|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
11064389|NCT01380145|EG000|Reported Event|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
11064390|NCT01380184|BG000|Baseline|Ridaforolimus 40 mg|In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
11064391|NCT01380184|FG000|Participant Flow|Ridaforolimus 40 mg|In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
11064392|NCT01380184|OG000|Outcome|Ridaforolimus 40 mg|In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
11064393|NCT01380184|EG000|Reported Event|Ridaforolimus 40 mg|In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
11064394|NCT01380197|BG000|Baseline|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
11064395|NCT01380197|BG001|Baseline|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
11064396|NCT01380197|BG002|Baseline|Total|Total of all reporting groups
11064397|NCT01380197|FG000|Participant Flow|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
11064398|NCT01380197|FG001|Participant Flow|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
11064399|NCT01380197|OG000|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
11064400|NCT01380197|OG001|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
11064401|NCT01380197|EG000|Reported Event|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
11064402|NCT01380197|EG001|Reported Event|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
11064403|NCT01380327|BG000|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
11064404|NCT01380327|BG001|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
11064405|NCT01380327|BG002|Baseline|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
11064406|NCT01380327|BG003|Baseline|Total|Total of all reporting groups
11064407|NCT01380327|FG000|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
11064408|NCT01380327|FG001|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
11064409|NCT01380327|FG002|Participant Flow|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
11064410|NCT01380327|OG000|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
11064411|NCT01380327|OG001|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
11149527|NCT01871285|EG000|Reported Event|MSE Dose Group 1 - Buprenorphine|Subjects in MSE Dose Group 1 who received at least one 300-μg buprenorphine HCl buccal film in either period
11064412|NCT01380327|OG002|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
11064413|NCT01380327|EG000|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) twice-daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
11064414|NCT01380327|EG001|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
11064415|NCT01380327|EG002|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily or twice-daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
11064416|NCT01380366|BG000|Baseline|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
11064417|NCT01380366|FG000|Participant Flow|Zorptive Subjects|Patients consent to rHGH and Intestinal Permeability in Intestinal Failure Study
11064418|NCT01380366|OG000|Outcome|Patients Experiencing Decrease in Concentration of Sucralose|A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
11064419|NCT01380366|OG000|Outcome|Patient Decreased Liver Injury|Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.
10848978|NCT00293202|FG000|Participant Flow|Etanercept|"Active Comparator: Etanercept 25 mg injection twice a week~5 Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week~Do not have active infections~Patient will be followed for 52 weeks"
11064420|NCT01380366|EG000|Reported Event|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
11064421|NCT01380379|BG000|Baseline|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
11064422|NCT01380379|FG000|Participant Flow|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
11064423|NCT01380379|OG000|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
11064424|NCT01380379|EG000|Reported Event|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
11064425|NCT01380535|BG000|Baseline|ECP Methoxsalen + SoC|Participants receive ECP methoxsalen in addition to standard of care
11064426|NCT01380535|BG001|Baseline|Standard of Care (SOC)|Participants receive only standard of care
11064427|NCT01380535|BG002|Baseline|Total|Total of all reporting groups
11064428|NCT01380535|FG000|Participant Flow|ECP Methoxsalen + SoC|Participants receive ECP methoxsalen in addition to standard of care
11064429|NCT01380535|FG001|Participant Flow|Standard of Care (SoC)|Participants receive only standard of care
11064430|NCT01380535|OG000|Outcome|ECP Methoxsalen + SoC|Participants receive ECP methoxsalen in addition to standard of care
11064431|NCT01380535|OG001|Outcome|Standard of Care (SoC)|Participants receive only standard of care
11064432|NCT01380535|EG000|Reported Event|ECP Methoxsalen + SoC|Participants receive ECP methoxsalen in addition to standard of care
11064433|NCT01380535|EG001|Reported Event|Standard of Care (SoC)|Participants receive only standard of care
11064434|NCT01380639|BG000|Baseline|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
11064435|NCT01380639|BG001|Baseline|Rehabilitation Without Vibration Training|
11064436|NCT01380639|BG002|Baseline|Total|Total of all reporting groups
11149528|NCT01871285|EG001|Reported Event|MSE Dose Group 1 - ATC Opioid|Subjects in MSE Dose Group 1 who received at least 1 dose of assigned ATC opioid in either period
11064437|NCT01380639|FG000|Participant Flow|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
11064438|NCT01380639|FG001|Participant Flow|Rehabilitation Without Vibration Training|
11064439|NCT01380639|OG000|Outcome|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
11064440|NCT01380639|OG001|Outcome|Rehabilitation Without Vibration Training|
11064441|NCT01380639|EG000|Reported Event|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
11064442|NCT01380639|EG001|Reported Event|Rehabilitation Without Vibration Training|control intervention : performing squats for 3x3 minutes on the floor three times a week
11064443|NCT01380691|BG000|Baseline|Overall|"Participants received 18 mg LY2216684 or Placebo-matching LY2216684 administered orally, once daily for 8 days during Periods 1 and 2. On Day 6 and on Day 8 of each period, participants were administered either 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men) or placebo-matching alcoholic beverage, taken orally, one time.~There was a 7-day washout period between Periods 1 and 2."
11064444|NCT01380691|FG000|Participant Flow|LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc|"Period 1: 18 milligrams (mg) LY2216684 (LY) administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic (Alc) beverage (with an alcohol dose of 0.6 grams per kilograms [g/kg] for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time.~Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time.~There was a 7-day washout period between Periods 1 and 2."
11064445|NCT01380691|FG001|Participant Flow|Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc|"Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time.~Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time.~There was a 7-day washout period between Periods 1 and 2."
11064446|NCT01380691|FG002|Participant Flow|LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc|"Period 1: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.~Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.~There was a 7-day washout period between Periods 1 and 2."
11064447|NCT01380691|FG003|Participant Flow|Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc|"Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.~Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.~There was a 7-day washout period between Periods 1 and 2."
11064448|NCT01380691|OG000|Outcome|LY2216684 + Alcohol|18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.
11064449|NCT01380691|OG001|Outcome|Placebo-matching LY2216684 + Alcohol|Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.
11064450|NCT01380691|OG002|Outcome|LY2216684 + Placebo-matching Alcohol|18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time.
11064451|NCT01380691|OG003|Outcome|Placebo-matching LY2216684 + Placebo-matching Alcohol|Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time.
11064452|NCT01380691|OG001|Outcome|LY2216684 + Placebo-matching Alcohol|18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time.
11064453|NCT01380691|EG000|Reported Event|LY2216684 + Placebo-matching Alcohol|18 mg LY2216684 administered orally, once daily for 8 days. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time.
11064454|NCT01380691|EG001|Reported Event|Placebo-matching LY2216684 + Placebo-matching Alcohol|Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time.
11064455|NCT01380691|EG002|Reported Event|LY2216684 + Alcohol|18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.
11149529|NCT01871285|EG002|Reported Event|MSE Dose Group 2 - Buprenorphine|Subjects in MSE Dose Group 2 who received at least one 450-μg buprenorphine HCl buccal film in either period
11064456|NCT01380691|EG003|Reported Event|Placebo-matching LY2216684 + Alcohol|Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.
11064457|NCT01380730|BG000|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11064458|NCT01380730|BG001|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11064459|NCT01380730|BG002|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064460|NCT01380730|BG003|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064461|NCT01380730|BG004|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064462|NCT01380730|BG005|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064463|NCT01380730|BG006|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064464|NCT01380730|BG007|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064465|NCT01380730|BG008|Baseline|Total|Total of all reporting groups
11064466|NCT01380730|FG000|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11064467|NCT01380730|FG001|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11064468|NCT01380730|FG002|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064469|NCT01380730|FG003|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064470|NCT01380730|FG004|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064471|NCT01380730|FG005|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064472|NCT01380730|FG006|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064473|NCT01380730|FG007|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064474|NCT01380730|OG000|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11064475|NCT01380730|OG001|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11064476|NCT01380730|OG002|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064477|NCT01380730|OG003|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064478|NCT01380730|OG004|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064479|NCT01380730|OG005|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064480|NCT01380730|OG006|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064481|NCT01380730|OG007|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064482|NCT01380730|EG000|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11064483|NCT01380730|EG001|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
11064484|NCT01380730|EG002|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064485|NCT01380730|EG003|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064486|NCT01380730|EG004|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11064487|NCT01380730|EG005|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064488|NCT01380730|EG006|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064489|NCT01380730|EG007|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
11064490|NCT01380743|BG000|Baseline|Cohort 1, Duvoglustat 50 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 50 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064491|NCT01380743|BG001|Baseline|Cohort 2, Duvoglustat 100 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 100 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
10848979|NCT00293202|FG001|Participant Flow|Placebo|"Placebo comparator: Saline injection twice a week~5 Hemodialysis patients will receive Saline by subcutaneous injection twice a week~Do not have active infections~Patient will be followed for 52 weeks"
11064492|NCT01380743|BG002|Baseline|Cohort 3, Duvoglustat 250 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 250 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11149530|NCT01871285|EG003|Reported Event|MSE Dose Group 2 - ATC Opioid|Subjects in MSE Dose Group 2 who received at least 1 dose of assigned ATC opioid in either period
11064493|NCT01380743|BG003|Baseline|Cohort 4, Duvoglustat 600 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 600 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064494|NCT01380743|BG004|Baseline|Total|Total of all reporting groups
11064495|NCT01380743|FG000|Participant Flow|Cohort 1, Duvoglustat 50 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 50 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064496|NCT01380743|FG001|Participant Flow|Cohort 2, Duvoglustat 100 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 100 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064497|NCT01380743|FG002|Participant Flow|Cohort 3, Duvoglustat 250 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 250 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064498|NCT01380743|FG003|Participant Flow|Cohort 4, Duvoglustat 600 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 600 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064499|NCT01380743|OG000|Outcome|Cohort 1, Duvoglustat 50 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 50 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064500|NCT01380743|OG001|Outcome|Cohort 2, Duvoglustat 100 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 100 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064501|NCT01380743|OG002|Outcome|Cohort 3, Duvoglustat 250 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 250 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064502|NCT01380743|OG003|Outcome|Cohort 4, Duvoglustat 600 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 600 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064503|NCT01380743|EG000|Reported Event|Cohort 1, Duvoglustat 50 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 50 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064504|NCT01380743|EG001|Reported Event|Cohort 2, Duvoglustat 100 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 100 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064505|NCT01380743|EG002|Reported Event|Cohort 3, Duvoglustat 250 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 250 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064506|NCT01380743|EG003|Reported Event|Cohort 4, Duvoglustat 600 mg + rhGAA|During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single 600 mg oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.
11064507|NCT01380769|BG000|Baseline|CRLX101 + BSC (Best Supportive Care)|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
11064508|NCT01380769|BG001|Baseline|BSC (Best Supportive Care) Alone|Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
11064509|NCT01380769|BG002|Baseline|Total|Total of all reporting groups
11064510|NCT01380769|FG000|Participant Flow|CRLX101 + BSC (Best Supportive Care)|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
11064511|NCT01380769|FG001|Participant Flow|BSC (Best Supportive Care) Alone|Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
11064512|NCT01380769|OG000|Outcome|CRLX101|CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
11064513|NCT01380769|OG001|Outcome|Best Supportive Care|Best Supportive Care: best supportive care
11064514|NCT01380769|EG000|Reported Event|CRLX101+BSC|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
11064515|NCT01380769|EG001|Reported Event|Best Supportive Care (BSC) Only|Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
11064516|NCT01380782|BG000|Baseline|Arm A Bevacizumab-naive|Bevacizumab-naive participants
11064517|NCT01380782|BG001|Baseline|Arm B Bevacizumab-treated|Bevacizumab-treated participants
11064518|NCT01380782|BG002|Baseline|Total|Total of all reporting groups
11064519|NCT01380782|FG000|Participant Flow|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
11064520|NCT01380782|FG001|Participant Flow|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
11064521|NCT01380782|FG002|Participant Flow|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
11149531|NCT01871402|BG000|Baseline|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
11064522|NCT01380782|FG003|Participant Flow|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
11064523|NCT01380782|OG000|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
11064524|NCT01380782|OG000|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
11064525|NCT01380782|OG001|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
11064526|NCT01380782|OG002|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
11064527|NCT01380782|OG003|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
11064528|NCT01380782|OG000|Outcome|All Participants (Arm A and B)|
11064529|NCT01380782|OG000|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
11064530|NCT01380782|OG001|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
11064531|NCT01380782|EG000|Reported Event|Arm A|Bevacizumab-naive participants
11064532|NCT01380782|EG001|Reported Event|Arm B|Bevacizumab-treated participants
11064533|NCT01380834|BG000|Baseline|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
11064534|NCT01380834|BG001|Baseline|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
11064535|NCT01380834|BG002|Baseline|Total|Total of all reporting groups
11064536|NCT01380834|FG000|Participant Flow|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
11064537|NCT01380834|FG001|Participant Flow|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
11064538|NCT01380834|OG000|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
11064539|NCT01380834|OG001|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
11064540|NCT01380834|EG000|Reported Event|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
11064541|NCT01380834|EG001|Reported Event|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
11064542|NCT01380899|BG000|Baseline|Parkinson Disease|Patients with Parkinson Disease: 34 Average. Age (mean SD) 66.82 (+11.4)
11064543|NCT01380899|BG001|Baseline|Atypical Parkinsonism|Participants with Atypical Parkinsonism degenerative (26) or secondary (7), total: 33
11064544|NCT01380899|BG002|Baseline|Control Group|Subjects without neurodegenerative disease and apparently good state of health (20)
11064545|NCT01380899|BG003|Baseline|Total|Total of all reporting groups
11064546|NCT01380899|FG000|Participant Flow|Parkinson Disease|Patients with Parkinson Disease (PD) PD is the patient initially presented asymmetric onset (with both rest and postural tremors with a frequency of between 5 and 7 Hz), rigidity, bradykinesia, postural instability, an acceptable and sustained response to levodopa, and previous and concomitant nonmotor characteristic semiology.
11066949|NCT01394276|OG000|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents. Participants receiving treatment with TCZ with dose of 8 milligrams mg/kg body weight, intravenously once every 4 weeks for 12 months were observed. Dosage of TCZ was prescribed according to EU approved dosage, and SmPC.
11149532|NCT01871402|BG001|Baseline|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
11149533|NCT01871402|BG002|Baseline|Total|Total of all reporting groups
11149534|NCT01871402|FG000|Participant Flow|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
11064547|NCT01380899|FG001|Participant Flow|Atypical Parkinsonism|"AP was divided into primary (neurodegenerative) and secondary (postencephalitic, vascular, drug-induced, toxic) groups.~The neurodegenerative included patients with the diagnosis of Lewy body dementia (LBD) used the consortium report on the DLB international workshop.~Patients with the diagnosis of AD used the recommendations from the National Institute on Aging and Alzheimer's Association workgroups on diagnostic guidelines for AD.~Patients with the diagnosis of MSA used the Second consensus statement on the diagnosis of multiple system atrophy.~The diagnosis PSP used the report of the NINDS-SPSP International Workshop. CBS and we included a case with a diagnosis of neurodegeneration with brain iron accumulation syndrome (NBIA).~Most of these criteria are summarized in the SIC Task Force appraisal of clinical diagnostic criteria for Parkinsonian disorders."
11064548|NCT01380899|FG002|Participant Flow|Control Group|Subjects apparently in a good state of health without antecedents of neurodegenerative diseases and not symptoms or signs of neurodegeneration (comparable with the group's problem in gender, age, and population characteristics).
11064549|NCT01380899|OG000|Outcome|Parkinson Disease|Patients with the clinical diagnosis of Parkinson Disease
11064550|NCT01380899|OG001|Outcome|Atypical Parkinsonism|Atypical parkinsonian conditions mainly comprise progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), multisystem atrophy (MSA), and dementia with Lewy bodies (DLB). Apart from these sporadic neurodegenerative disorders, atypical parkinsonism has also been described in various other inherited degenerative conditions such as frontotemporal dementia (FTD), Alzheimer's disease, and Perry syndrome. Nondegenerative parkinsonisms include vascular, toxic (use of neuroleptics, exposure to manganese, carbon monoxide, etc.), and traumatic.
11064551|NCT01380899|OG002|Outcome|Control Group|Apparently, healthy subjects without a family history of neurodegenerative or chronic diseases could have population characteristics comparable to the problem groups' participants.
11064552|NCT01380899|EG000|Reported Event|PD (n = 34)|We enrolled 34 participants who had PD.
11064553|NCT01380899|EG001|Reported Event|Atypical Parkinsonism (n=33)|A total of 33 patients had AP: from they 26 were found to have a neurodegenerative disease clinically (18 had a synucleinopathy-related diagnosis: MSA, LBD, and 8 had tauopathies: PSP, AD). We also included seven patients with secondary parkinsonism.
11064554|NCT01380899|EG002|Reported Event|Control Group (n=20)|A control group (n = 20) of similar age and sex distribution to the patient population was included. There was no significant difference in either age or evolution of disease between the two groups with parkinsonism.
11064555|NCT01380990|BG000|Baseline|Gene Therapy|The safety population consists of all OTL-101*-treated subjects (on-study and CUP). The secondary efficacy population consists of all OTL-101*-treated subjects (on-study and CUP).
11064556|NCT01380990|BG001|Baseline|Historical Control Group|Complete HSCT historical control group consisting of ADA-SCID patients with any type of donor treated with HSCT at GOSH from 2000 to 2016 (referred to as the All HSCT Controls group)
11064557|NCT01380990|BG002|Baseline|Total|Total of all reporting groups
11064558|NCT01380990|FG000|Participant Flow|Gene Therapy|"Infusion of autologous EF1αS-ADA (EFS-ADA) lentiviral vector (LV) mediated gene modification of autologous CD34+ cells~Infusion of autologous EFS-ADA LV CD34+ cells: Autologous EFS-ADA LV CD34+ cells (OTL-101*) are infused intravenously~Busulfan: Busulfan is used for non-myeloablative conditioning~Polyethylene glycol-modified adenosine deaminase (PEG-ADA): PEG-ADA enzyme replacement therapy (ERT) is discontinued at Day +3- (-3/+15 days) after successful engraftment"
11064559|NCT01380990|FG001|Participant Flow|Historical Control Group|"Historical data from patients with Severe Combined Immunodeficiency Due to ADA Deficiency (ADA-SCID) who were treated with Hematopoietic Stem Cell Transplantation (HSCT)~Haematopoietic Stem Cell Transplantation (HSCT): Historical data from a database of ADA-SCID patients treated with allogeneic HSCT from Great Ormond Street Hospital (GOSH) will be collected as comparator group."
11064560|NCT01380990|OG000|Outcome|OTL-101* On-Study Subjects|The primary efficacy population for analysis consists of the on-study OTL-101*-treated subjects.
11064561|NCT01380990|OG001|Outcome|OTL-101* On-Study and CUP Subjects|The safety population consists of all OTL-101*-treated subjects (on-study and CUP). The secondary efficacy population consists of all OTL-101*-treated subjects (on-study and CUP).
11064562|NCT01380990|OG002|Outcome|HSCT Controls Without MRD|The primary efficacy population from the HSCT historical control cohort comprises ADA-SCID patients without a medically eligible Matched Related Donor (MRD) who were treated with HSCT at GOSH from 2000 to 2016. An MRD refers to either a matched sibling or family donor.
10887342|NCT00499889|FG000|Participant Flow|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
11064563|NCT01380990|OG003|Outcome|HSCT Controls With MRD|Secondary efficacy population for comparison comprise ADA-SCID patients with an MRD treated with HSCT at GOSH from 2000 to 2016
11064564|NCT01380990|OG004|Outcome|All HSCT Controls|Complete HSCT historical control group consisting of ADA-SCID patients with any type of donor treated with HSCT at GOSH from 2000 to 2016 (referred to as the All HSCT Controls group)
11064565|NCT01380990|OG002|Outcome|HSCT Controls Without MRD|The primary efficacy population from the HSCT historical control cohort comprises ADA-SCID patients without a medically eligible MRD who were treated with HSCT at GOSH from 2000 to 2016. An MRD refers to either a matched sibling or family donor.
11064566|NCT01380990|EG000|Reported Event|OTL-101* On-Study and CUP Subjects|The safety population consists of all OTL-101*-treated subjects (on-study and CUP).
11064567|NCT01380990|EG001|Reported Event|OTL-101* On-Study Subjects|The safety population for analysis consists of the on-study OTL-101*-treated subjects.
11064568|NCT01381016|BG000|Baseline|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064569|NCT01381016|BG001|Baseline|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064570|NCT01381016|BG002|Baseline|Total|Total of all reporting groups
11064571|NCT01381016|FG000|Participant Flow|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064572|NCT01381016|FG001|Participant Flow|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064573|NCT01381016|OG000|Outcome|Group 1 - Normal Weight|"Group 1: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064574|NCT01381016|OG001|Outcome|Group 2 - Obese|"Group 2: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064575|NCT01381016|OG000|Outcome|Control|"Group 1: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064576|NCT01381016|OG001|Outcome|Experimental|"Group 2: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064577|NCT01381016|EG000|Reported Event|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064578|NCT01381016|EG001|Reported Event|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
11064579|NCT01381068|BG000|Baseline|Monitored Arm|"The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55.~End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms."
11064580|NCT01381068|BG001|Baseline|Control Arm|"The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment.~End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms."
11064581|NCT01381068|BG002|Baseline|Total|Total of all reporting groups
11064582|NCT01381068|FG000|Participant Flow|Monitored Arm|"The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55.~End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms."
11064583|NCT01381068|FG001|Participant Flow|Control Arm|"The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment.~End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms."
11064584|NCT01381068|OG000|Outcome|Monitored Arm|"The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55.~End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms."
11064585|NCT01381068|OG001|Outcome|Control Arm|"The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment.~End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms."
11064586|NCT01381068|EG000|Reported Event|Monitored Arm|"The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55.~End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms."
11064587|NCT01381068|EG001|Reported Event|Control Arm|"The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment.~End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms."
11064588|NCT01381120|BG000|Baseline|VESIcare + Narcotic Painkiller|
11064589|NCT01381120|BG001|Baseline|Narcotic Painkiller|
11064590|NCT01381120|BG002|Baseline|Total|Total of all reporting groups
11064591|NCT01381120|FG000|Participant Flow|VESIcare + Narcotic Painkiller|
11064592|NCT01381120|FG001|Participant Flow|Narcotic Painkiller|
11064593|NCT01381120|OG000|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
11064594|NCT01381120|OG001|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
11064595|NCT01381120|EG000|Reported Event|VESIcare + Narcotic Painkiller|
11064596|NCT01381120|EG001|Reported Event|Narcotic Painkiller|
11064597|NCT01381172|BG000|Baseline|Treatment|"The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.~Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11064598|NCT01381172|BG001|Baseline|Control|"The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.~No intervention: Optimal medical therapy: The control group receives optimal medical therapy only."
11064599|NCT01381172|BG002|Baseline|Total|Total of all reporting groups
11149535|NCT01871402|FG001|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
11149536|NCT01871402|OG000|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
11064600|NCT01381172|FG000|Participant Flow|Treatment|"The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.~Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11064601|NCT01381172|FG001|Participant Flow|Control|"The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.~No intervention: Optimal medical therapy: The control group receives optimal medical therapy only."
11064602|NCT01381172|OG000|Outcome|Treatment|"The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.~Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11064603|NCT01381172|OG001|Outcome|Control|"The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.~No intervention: Optimal medical therapy: The control group receives optimal medical therapy only."
11064604|NCT01381172|EG000|Reported Event|Treatment|"The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.~Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11064605|NCT01381172|EG001|Reported Event|Control|"The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.~No intervention: Optimal medical therapy: The control group receives optimal medical therapy only."
11064606|NCT01381406|BG000|Baseline|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
11064607|NCT01381406|BG001|Baseline|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
11064608|NCT01381406|BG002|Baseline|Total|Total of all reporting groups
11064609|NCT01381406|FG000|Participant Flow|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period
11064610|NCT01381406|FG001|Participant Flow|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
11064611|NCT01381406|OG000|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
11064612|NCT01381406|OG001|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
11064613|NCT01381406|EG000|Reported Event|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
11064614|NCT01381406|EG001|Reported Event|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
11066950|NCT01394276|OG000|Outcome|DMARD-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
11066951|NCT01394276|OG001|Outcome|DMARD + Anti-TNF-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
11066952|NCT01394276|OG000|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
11066953|NCT01394276|OG001|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
11066954|NCT01394276|EG000|Reported Event|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
11066955|NCT01394510|BG000|Baseline|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
11066956|NCT01394510|FG000|Participant Flow|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
11066957|NCT01394510|OG000|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
11149537|NCT01871402|OG001|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
11149538|NCT01871402|EG000|Reported Event|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
11149539|NCT01871402|EG001|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
11064615|NCT01381471|BG000|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
11064616|NCT01381471|FG000|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
11064617|NCT01381471|OG000|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
11064618|NCT01381471|EG000|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
11064619|NCT01381549|BG000|Baseline|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064620|NCT01381549|BG001|Baseline|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064621|NCT01381549|BG002|Baseline|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
11064622|NCT01381549|BG003|Baseline|Total|Total of all reporting groups
11064623|NCT01381549|FG000|Participant Flow|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 milligram (mg), in 200 or 250 millilitre (mL) saline solution as intravenous (IV) infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064624|NCT01381549|FG001|Participant Flow|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064625|NCT01381549|FG002|Participant Flow|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
11064626|NCT01381549|OG000|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064627|NCT01381549|OG001|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064628|NCT01381549|OG002|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
11064629|NCT01381549|OG000|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064630|NCT01381549|EG000|Reported Event|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064631|NCT01381549|EG001|Reported Event|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
11064632|NCT01381549|EG002|Reported Event|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
11064633|NCT01381562|BG000|Baseline|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
11064634|NCT01381562|BG001|Baseline|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
11064635|NCT01381562|BG002|Baseline|Meropenem 1 g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
11064636|NCT01381562|BG003|Baseline|Total|Total of all reporting groups
11064637|NCT01381562|FG000|Participant Flow|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 millilitre (mL) saline solution as intravenous (IV) infusion administered over 60 minutes, twice a day (BID) and meropenem matching placebo solution, 100 ml, administered over 30 minutes, thrice a day (TID) from Day 2 to Day 14 of the study.
11064638|NCT01381562|FG001|Participant Flow|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
11064639|NCT01381562|FG002|Participant Flow|Meropenem 1.0 g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
11064640|NCT01381562|OG000|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
11064641|NCT01381562|OG001|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
11064642|NCT01381562|OG002|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
11064643|NCT01381562|EG000|Reported Event|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
11064644|NCT01381562|EG001|Reported Event|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
11064645|NCT01381562|EG002|Reported Event|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
11064646|NCT01381575|BG000|Baseline|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064647|NCT01381575|BG001|Baseline|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064648|NCT01381575|BG002|Baseline|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064649|NCT01381575|BG003|Baseline|Total|Total of all reporting groups
11064650|NCT01381575|FG000|Participant Flow|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064651|NCT01381575|FG001|Participant Flow|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064652|NCT01381575|FG002|Participant Flow|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064653|NCT01381575|OG000|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064654|NCT01381575|OG001|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064655|NCT01381575|OG000|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064656|NCT01381575|OG002|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064657|NCT01381575|EG000|Reported Event|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064658|NCT01381575|EG001|Reported Event|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064659|NCT01381575|EG002|Reported Event|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
11064660|NCT01381692|BG000|Baseline|Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064661|NCT01381692|BG001|Baseline|Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064662|NCT01381692|BG002|Baseline|Total|Total of all reporting groups
11064663|NCT01381692|FG000|Participant Flow|Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064664|NCT01381692|FG001|Participant Flow|Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064665|NCT01381692|FG002|Participant Flow|Arm C (Phase I: Temsirolimus Dose Level 3, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 3 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064666|NCT01381692|FG003|Participant Flow|Arm D (Phase I: Temsirolimus Dose Level 4, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 4 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064667|NCT01381692|FG004|Participant Flow|Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone)|Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064668|NCT01381692|FG005|Participant Flow|Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and rituximab, bortezomib, and dexamethasone as in arm E. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064669|NCT01381692|OG000|Outcome|Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064670|NCT01381692|OG001|Outcome|Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064671|NCT01381692|OG000|Outcome|Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone)|Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064672|NCT01381692|OG001|Outcome|Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and rituximab, bortezomib, and dexamethasone as in arm E. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064673|NCT01381692|EG000|Reported Event|Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064674|NCT01381692|EG001|Reported Event|Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)|Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11064675|NCT01381718|BG000|Baseline|Arm I - Modafanil|"Participants receive modafinil orally (PO) once daily (QD) on days 1-42.~modafinil: Given PO"
11064676|NCT01381718|BG001|Baseline|Arm II - Placebo|"Participants receive placebo PO QD on days 1-42.~placebo: Given PO"
11064677|NCT01381718|BG002|Baseline|Total|Total of all reporting groups
11064678|NCT01381718|FG000|Participant Flow|Arm I - Modafinil|"Participants receive modafinil orally (PO) once daily (QD) on days 1-42.~modafinil: Given PO"
11064679|NCT01381718|FG001|Participant Flow|Arm II - Placebo|"Participants receive placebo PO QD on days 1-42.~placebo: Given PO"
11064680|NCT01381718|OG000|Outcome|Arm I - Modafinil|"Participants receive modafinil orally (PO) once daily (QD) on days 1-42.~modafinil: Given PO"
11064681|NCT01381718|OG001|Outcome|Arm II - Placebo|"Participants receive placebo PO QD on days 1-42.~placebo: Given PO"
11064682|NCT01381718|EG000|Reported Event|Arm I - Modafanil|"Participants receive modafinil orally (PO) once daily (QD) on days 1-42.~modafinil: Given PO"
11064683|NCT01381718|EG001|Reported Event|Arm II - Placebo|"Participants receive placebo PO QD on days 1-42.~placebo: Given PO"
11064684|NCT01381861|BG000|Baseline|TRC105|Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
11064685|NCT01381861|FG000|Participant Flow|TRC105|Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
11064686|NCT01381861|OG000|Outcome|TRC105|Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
11064687|NCT01381861|EG000|Reported Event|TRC105|Chimeric monoclonal antibody (TRC105) to CD105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
11064688|NCT01381874|BG000|Baseline|Exemestane|Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064689|NCT01381874|BG001|Baseline|Abiraterone Acetate + Prednisone|Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064690|NCT01381874|BG002|Baseline|Abiraterone Acetate + Exemestane + Prednisone|Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064691|NCT01381874|BG003|Baseline|Total|Total of all reporting groups
11064692|NCT01381874|FG000|Participant Flow|Exemestane|Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064693|NCT01381874|FG001|Participant Flow|Abiraterone Acetate + Prednisone|Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064694|NCT01381874|FG002|Participant Flow|Abiraterone Acetate + Exemestane + Prednisone|Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064695|NCT01381874|OG000|Outcome|Exemestane|Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064696|NCT01381874|OG001|Outcome|Abiraterone Acetate + Prednisone|Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064697|NCT01381874|OG002|Outcome|Abiraterone Acetate + Exemestane + Prednisone|Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064698|NCT01381874|EG000|Reported Event|Exemestane|Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064699|NCT01381874|EG001|Reported Event|Abiraterone Acetate + Prednisone|Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064700|NCT01381874|EG002|Reported Event|Abiraterone Acetate + Exemestane + Prednisone|Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
11064701|NCT01381900|BG000|Baseline|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064702|NCT01381900|BG001|Baseline|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064703|NCT01381900|BG002|Baseline|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064704|NCT01381900|BG003|Baseline|Total|Total of all reporting groups
11064705|NCT01381900|FG000|Participant Flow|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064706|NCT01381900|FG001|Participant Flow|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064707|NCT01381900|FG002|Participant Flow|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064708|NCT01381900|OG000|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064709|NCT01381900|OG001|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064710|NCT01381900|OG002|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064711|NCT01381900|EG000|Reported Event|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064712|NCT01381900|EG001|Reported Event|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064713|NCT01381900|EG002|Reported Event|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
11064714|NCT01381926|BG000|Baseline|Placebo 1st Then Exenatide|"Study participants in period1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a wash out period prior to the second periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals."
11064715|NCT01381926|BG001|Baseline|Exenatide 1st Then Placebo|"Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a wash out period prior to the second period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals."
11064716|NCT01381926|BG002|Baseline|Total|Total of all reporting groups
11064717|NCT01381926|FG000|Participant Flow|Exenatide 1st Then Placebo|"Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a wash out period prior to the second period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals."
11064718|NCT01381926|FG001|Participant Flow|Placebo 1st Then Exenatide|"Study participants in periods1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a wash out period prior to the second periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals."
11064719|NCT01381926|OG000|Outcome|Exenatide 1st Then Placebo|"Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a wash out period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals."
11064720|NCT01381926|OG001|Outcome|Placebo 1st Then Exenatide|"Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a wash out period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals."
11064721|NCT01381926|OG000|Outcome|Exenatide Then Placebo|"Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a wash out period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mg and exenatide 10mg, respectively, subcutaneously twice daily before meals.~exenatide: exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively."
11064722|NCT01381926|OG001|Outcome|Placebo Then Exenatide|"Study participants in phase1 will receive the saline placebo, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a wash out period prior to the second phase of the study. During the fourth month study participants will receive Exenatide 5mcg twice daily with meals. During the fifth month, study participants will receive exenatide 10mcg, subcutaneously twice daily before meals.~exenatide: exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively."
11064723|NCT01381926|EG000|Reported Event|Exenatide 1st Then Placebo|"Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a wash out period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals."
11064724|NCT01381926|EG001|Reported Event|Placebo 1st Then Exenatide|"Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a wash out period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals."
11064725|NCT01381952|BG000|Baseline|AlluraXper - ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
11064726|NCT01381952|FG000|Participant Flow|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
11064727|NCT01381952|OG000|Outcome|AlluraXper|Angiogram with AlluraXper followed by angiogram with ClarityIQ
11064728|NCT01381952|OG001|Outcome|Allura Clarity|Angiogram with AlluraXper followed by angiogram with ClarityIQ
11064729|NCT01381952|OG000|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
11064730|NCT01381952|EG000|Reported Event|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
11064731|NCT01382108|BG000|Baseline|Normal Participants|Participants without meibomian gland dysfunction
11064732|NCT01382108|BG001|Baseline|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
11064733|NCT01382108|BG002|Baseline|Total|Total of all reporting groups
11064734|NCT01382108|FG000|Participant Flow|Normal Participants|Participants without Meibomian Gland Dysfunction
11064735|NCT01382108|FG001|Participant Flow|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
11064736|NCT01382108|OG000|Outcome|Normal Participants|Participants without Meibomian Gland Dysfunction
11064737|NCT01382108|OG001|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
11064738|NCT01382108|OG000|Outcome|Normal Participants|Participants without meibomian gland dysfunction
11064739|NCT01382108|EG000|Reported Event|Normal Participants|Participants without meibomian gland dysfunction
11064740|NCT01382108|EG001|Reported Event|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
11064741|NCT01382186|BG000|Baseline|Purposive Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
11064742|NCT01382186|BG001|Baseline|Random Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
11064743|NCT01382186|BG002|Baseline|Total|Total of all reporting groups
11064744|NCT01382186|FG000|Participant Flow|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
11064745|NCT01382186|FG001|Participant Flow|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
11064746|NCT01382186|OG000|Outcome|Purposive Sampling: Able to Complete Task|Veterans in this arm were able to complete the task.
11064747|NCT01382186|OG001|Outcome|Purposive Sampling: Able to Complete Task With Difficulty|Veterans in this arm were able to complete task with some difficulty.
11064748|NCT01382186|OG002|Outcome|Purposive Sampling: Not Able to Complete Task|Veterans in this arm were not able to complete the task.
11064749|NCT01382186|OG000|Outcome|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
11064750|NCT01382186|OG000|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
11064751|NCT01382186|EG000|Reported Event|Purposive Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
11064752|NCT01382186|EG001|Reported Event|Random Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
11064753|NCT01382212|BG000|Baseline|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
11064754|NCT01382212|FG000|Participant Flow|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
11064755|NCT01382212|OG000|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
11064756|NCT01382212|EG000|Reported Event|Paricalcitol|Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
11064757|NCT01382225|BG000|Baseline|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
11064758|NCT01382225|BG001|Baseline|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
11064759|NCT01382225|BG002|Baseline|Total|Total of all reporting groups
11064760|NCT01382225|FG000|Participant Flow|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
11064761|NCT01382225|FG001|Participant Flow|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
11064762|NCT01382225|OG000|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
11064763|NCT01382225|OG001|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
11064764|NCT01382225|EG000|Reported Event|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
11064765|NCT01382225|EG001|Reported Event|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
11064766|NCT01382251|BG000|Baseline|Ambulatory Surgery Patients|Only patients with caregivers were recruited
11064767|NCT01382251|BG001|Baseline|Ambulatory Surgery Caregivers|Caregivers were recruited with the patients receiving surgery
11064768|NCT01382251|BG002|Baseline|Total|Total of all reporting groups
11064769|NCT01382251|FG000|Participant Flow|Ambulatory Surgery Patients|
11064770|NCT01382251|FG001|Participant Flow|Ambulatory Surgery Caregivers|
11064771|NCT01382251|OG000|Outcome|Ambulatory Surgery Patients|
11064772|NCT01382251|OG001|Outcome|Ambulatory Surgery Caregivers|
11064773|NCT01382251|EG000|Reported Event|Ambulatory Surgery Patients|
11064774|NCT01382303|BG000|Baseline|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
11064775|NCT01382303|BG001|Baseline|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
11064776|NCT01382303|BG002|Baseline|Total|Total of all reporting groups
11064777|NCT01382303|FG000|Participant Flow|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
11064778|NCT01382303|FG001|Participant Flow|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
11064779|NCT01382303|OG000|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
11064780|NCT01382303|OG001|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
11064781|NCT01382303|EG000|Reported Event|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
11064782|NCT01382303|EG001|Reported Event|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
11064783|NCT01382446|BG000|Baseline|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
11064784|NCT01382446|BG001|Baseline|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
11064785|NCT01382446|BG002|Baseline|Total|Total of all reporting groups
11064786|NCT01382446|FG000|Participant Flow|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
11064787|NCT01382446|FG001|Participant Flow|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
11064788|NCT01382446|OG000|Outcome|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
11064789|NCT01382446|OG001|Outcome|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
11064790|NCT01382446|EG000|Reported Event|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
11064791|NCT01382446|EG001|Reported Event|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
11064792|NCT01382602|BG000|Baseline|AMDC-USR|Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection.
11064793|NCT01382602|BG001|Baseline|Placebo|Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection.
11064794|NCT01382602|BG002|Baseline|Total|Total of all reporting groups
11064795|NCT01382602|FG000|Participant Flow|AMDC-USR|Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of AMDC-USR at the 12 months follow-up.
11064796|NCT01382602|FG001|Participant Flow|Placebo|Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up, subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received open-label AMDC-USR treatment were followed for 2 years after initial placebo treatment. Analysis population is based on subjects that received at least 1 treatment of placebo at the 12 months follow-up.
11064797|NCT01382602|OG000|Outcome|AMDC-USR|Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection.
11064798|NCT01382602|OG001|Outcome|Placebo|Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection.
11064799|NCT01382602|EG000|Reported Event|AMDC-USR|Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that underwent at least 1 treatment of AMDC-USR, at the 12 month follow-up.
11064800|NCT01382602|EG001|Reported Event|Placebo|Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that underwent at least 1 treatment of placebo, at the 12 month follow-up.
11064801|NCT01382719|BG000|Baseline|Placebo|identical formulation without active ingredient
11064802|NCT01382719|BG001|Baseline|Bremelanotide Arm 1|low dose 0.75 mg BMT
11064803|NCT01382719|BG002|Baseline|Bremelanotide Arm 2|middle dose 1.25 mg BMT
11064804|NCT01382719|BG003|Baseline|Bremelanotide Arm 3|high dose 1.75 mg BMT
11064805|NCT01382719|BG004|Baseline|Total|Total of all reporting groups
11064806|NCT01382719|FG000|Participant Flow|Placebo|identical formulation without active ingredient
11064807|NCT01382719|FG001|Participant Flow|Bremelanotide Arm 1|low dose 0.75 mg BMT
11064808|NCT01382719|FG002|Participant Flow|Bremelanotide Arm 2|middle dose 1.25 mg BMT
11064809|NCT01382719|FG003|Participant Flow|Bremelanotide Arm 3|high dose 1.75 mg BMT
11064810|NCT01382719|OG000|Outcome|Placebo|identical formulation without active ingredient
11064811|NCT01382719|OG001|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
11064812|NCT01382719|OG002|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
11064813|NCT01382719|OG003|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
11064814|NCT01382719|EG000|Reported Event|Placebo|identical formulation without active ingredient
11064815|NCT01382719|EG001|Reported Event|Bremelanotide Arm 1|low dose 0.75 mg BMT
11064816|NCT01382719|EG002|Reported Event|Bremelanotide Arm 2|middle dose 1.25 mg BMT
11064817|NCT01382719|EG003|Reported Event|Bremelanotide Arm 3|high dose 1.75 mg BMT
11064818|NCT01382901|BG000|Baseline|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
11064819|NCT01382901|BG001|Baseline|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
11064820|NCT01382901|BG002|Baseline|Total|Total of all reporting groups
11064821|NCT01382901|FG000|Participant Flow|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
11064822|NCT01382901|FG001|Participant Flow|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
11064823|NCT01382901|OG000|Outcome|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
11064824|NCT01382901|OG001|Outcome|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
11064825|NCT01382901|EG000|Reported Event|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
11064826|NCT01382901|EG001|Reported Event|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
11064827|NCT01382940|BG000|Baseline|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
11064828|NCT01382940|FG000|Participant Flow|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
11064829|NCT01382940|OG000|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
11064830|NCT01382940|EG000|Reported Event|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
11064831|NCT01383005|BG000|Baseline|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
11064832|NCT01383005|BG001|Baseline|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
11064833|NCT01383005|BG002|Baseline|Total|Total of all reporting groups
11064834|NCT01383005|FG000|Participant Flow|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
11064835|NCT01383005|FG001|Participant Flow|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
11064836|NCT01383005|OG000|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
11064837|NCT01383005|OG000|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
11064838|NCT01383005|OG001|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
11064839|NCT01383005|EG000|Reported Event|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
11064840|NCT01383018|BG000|Baseline|AMS Penile Prosthesis Recipients|"Men for whom an AMS penile prosthesis is recommended~AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices."
11064841|NCT01383018|FG000|Participant Flow|AMS Penile Prosthesis Recipients|"Men for whom an AMS penile prosthesis is recommended~AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices."
11064842|NCT01383018|OG000|Outcome|All AMS Penile Prosthesis Recipients - Total Reponses|"Men for whom an AMS penile prosthesis is recommended~AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis."
11064843|NCT01383018|OG001|Outcome|AMS 700|"AMS 700, only~Men for whom an AMS 700 penile prosthesis was recommended"
11064844|NCT01383018|OG002|Outcome|AMS Ambicor|"AMS Ambicor, only~Men for whom an AMS Ambicor penile prosthesis was recommended"
11064845|NCT01383018|OG003|Outcome|Spectra|"Spectra, only~Men for whom a Spectra penile prosthesis was recommended"
11064846|NCT01383018|OG000|Outcome|All AMS Penile Prosthesis Recipients - Total Reponses|"Men for whom an AMS penile prosthesis was recommended~AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving a marketed AMS penile prosthesis."
11064847|NCT01383018|OG000|Outcome|UCLA-PCI Sexual Function|Sexual function measure
11064848|NCT01383018|OG001|Outcome|UCLA-PCI Urinary Function|Urinary function measure
11064849|NCT01383018|OG002|Outcome|UCLA-PCI Bowel Function|Bowel function measure
11064850|NCT01383018|OG003|Outcome|UCLA-PCI Sexual Bother|Sexual bother measure
11064851|NCT01383018|OG004|Outcome|UCLA-PCI Urinary Bother|Urinary bother measure
11064852|NCT01383018|OG005|Outcome|UCLA-PCI Bowel Bother|Bowel bother measure
11064853|NCT01383018|EG000|Reported Event|AMS Penile Prosthesis Receipients|"Men for whom an AMS penile prosthesis is recommended~AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices."
11064854|NCT01383096|BG000|Baseline|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
11064855|NCT01383096|BG001|Baseline|Cohort 2|Subjects received a single dose of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
11064856|NCT01383096|BG002|Baseline|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
11064857|NCT01383096|BG003|Baseline|Total|Total of all reporting groups
11064858|NCT01383096|FG000|Participant Flow|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
11064859|NCT01383096|FG001|Participant Flow|Cohort 2|Subjects received a single of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
11064860|NCT01383096|FG002|Participant Flow|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
11064861|NCT01383096|OG000|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
11064862|NCT01383096|OG001|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
11064863|NCT01383096|OG002|Outcome|Cohort 1 - Treatment:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
11064864|NCT01383096|OG003|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
11064865|NCT01383096|OG004|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
11064866|NCT01383096|OG005|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted
11064867|NCT01383096|OG006|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
11064868|NCT01383096|OG007|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
11064869|NCT01383096|OG008|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
11064870|NCT01383096|OG009|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
11064871|NCT01383096|OG010|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
11064872|NCT01383096|OG000|Outcome|Cohort 1 - Treatement A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
11064873|NCT01383096|OG001|Outcome|Cohort 1 - Treatement B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
11064874|NCT01383096|OG002|Outcome|Cohort 1 - Treatment C:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
11064875|NCT01383096|OG003|Outcome|Cohort 1 - Treatement D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
11064876|NCT01383096|OG004|Outcome|Cohort 1 - Treatement E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
11064877|NCT01383096|OG005|Outcome|Cohort 2 - Treatement F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
11064878|NCT01383096|OG006|Outcome|Cohort 2 - Treatement G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
11064879|NCT01383096|OG007|Outcome|Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
11064880|NCT01383096|OG008|Outcome|Cohort 2 - Treatement I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
11064881|NCT01383096|OG009|Outcome|Cohort 3 - Treatement J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
11064882|NCT01383096|OG010|Outcome|Cohort 3 - Treatement K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
11064883|NCT01383096|OG002|Outcome|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
11064884|NCT01383096|OG005|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
11064885|NCT01383096|EG000|Reported Event|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
11064886|NCT01383096|EG001|Reported Event|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
11064887|NCT01383096|EG002|Reported Event|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
11064888|NCT01383096|EG003|Reported Event|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
11064889|NCT01383096|EG004|Reported Event|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
11064890|NCT01383096|EG005|Reported Event|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
11064891|NCT01383096|EG006|Reported Event|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
11064892|NCT01383096|EG007|Reported Event|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
11064893|NCT01383096|EG008|Reported Event|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
11064894|NCT01383096|EG009|Reported Event|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
11064895|NCT01383096|EG010|Reported Event|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
11064896|NCT01383161|BG000|Baseline|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
11064897|NCT01383161|BG001|Baseline|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
11064898|NCT01383161|BG002|Baseline|Total|Total of all reporting groups
11064899|NCT01383161|FG000|Participant Flow|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
11064900|NCT01383161|FG001|Participant Flow|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
11064901|NCT01383161|OG000|Outcome|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
11064902|NCT01383161|OG001|Outcome|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
11064903|NCT01383161|EG000|Reported Event|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
11064904|NCT01383161|EG001|Reported Event|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
11064905|NCT01383174|BG000|Baseline|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
11064906|NCT01383174|BG001|Baseline|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
11064907|NCT01383174|BG002|Baseline|Total|Total of all reporting groups
11064908|NCT01383174|FG000|Participant Flow|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
11064909|NCT01383174|FG001|Participant Flow|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
11064910|NCT01383174|OG000|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
11064911|NCT01383174|OG001|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
11064912|NCT01383174|EG000|Reported Event|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
11064913|NCT01383174|EG001|Reported Event|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
11064914|NCT01383200|BG000|Baseline|TetracaineRight Eye / LidocaineLeft Eye|0.5% tetracaine drops Right eye /2% lidocaine gel Left eye
11064915|NCT01383200|BG001|Baseline|TetracaineLeft Eye /LidocaineRight Eye|0.5% tetracaine drops Left eye / 2% lidocaine gel Right eye
11064916|NCT01383200|BG002|Baseline|Total|Total of all reporting groups
11064917|NCT01383200|FG000|Participant Flow|Tetracaine Right Eye / Lidocaine Left Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel~11 eyes received 0.5% tetracaine drops."
11064918|NCT01383200|FG001|Participant Flow|Tetracaine Left Eye / Lidocaine Right Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel~11 eyes received 20% lidocaine gel."
11064919|NCT01383200|OG000|Outcome|Tetracaine|0.5% tetracaine drops
11064920|NCT01383200|OG001|Outcome|Lidocaine|2% lidocaine gel
11064921|NCT01383200|EG000|Reported Event|Tetracaine Right Eye / Lidocaine Left Eye|0.5% Tetracaine drops Right eye / 2% Lidocaine Left eye
11064922|NCT01383200|EG001|Reported Event|Tetracaine Left Eye / Lidocaine Right Eye|0.5% Tetracaine Left eye / 2% Lidocaine Right eye
11064923|NCT01383213|BG000|Baseline|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
11064924|NCT01383213|BG001|Baseline|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
11064925|NCT01383213|BG002|Baseline|Total|Total of all reporting groups
11064926|NCT01383213|FG000|Participant Flow|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
11064927|NCT01383213|FG001|Participant Flow|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
11064928|NCT01383213|OG000|Outcome|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%~Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
11064929|NCT01383213|OG001|Outcome|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.~Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
11064930|NCT01383213|EG000|Reported Event|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%~Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
11064931|NCT01383213|EG001|Reported Event|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.~Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
11064932|NCT01383317|BG000|Baseline|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
11064933|NCT01383317|BG001|Baseline|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
11064934|NCT01383317|BG002|Baseline|Total|Total of all reporting groups
11064935|NCT01383317|FG000|Participant Flow|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
11064936|NCT01383317|FG001|Participant Flow|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
11064937|NCT01383317|OG000|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
11064938|NCT01383317|OG001|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
11064939|NCT01383317|EG000|Reported Event|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
11064940|NCT01383317|EG001|Reported Event|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
11064941|NCT01383356|BG000|Baseline|Entire Study Population|Total number of subjects randomised and treated in the study.
11064942|NCT01383356|FG000|Participant Flow|Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg|Combination tablet Linagliptin (Lina) /Metformin (Met) 2.5mg/500mg followed by single tablets Linagliptin 2.5mg plus Metformin 500mg
11064943|NCT01383356|FG001|Participant Flow|Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg|Single tablets Linagliptin 2.5mg plus Metformin 500mg followed by combination tablet Linagliptin/Metformin 2.5mg/500mg
11064944|NCT01383356|OG000|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
11064945|NCT01383356|OG001|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
11064946|NCT01383356|EG000|Reported Event|Lina/Met 2.5mg/500mg|Combination tablet
11064947|NCT01383356|EG001|Reported Event|Lina 2.5mg Plus Met 500mg|Single tablets
11064948|NCT01383421|BG000|Baseline|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (without taking participation in the study into account), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated by ADA for their RA."
11064949|NCT01383421|FG000|Participant Flow|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated by ADA for their RA."
11064950|NCT01383421|OG000|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
11064951|NCT01383421|OG001|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
11064952|NCT01383421|OG000|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
11064953|NCT01383421|OG001|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
11064954|NCT01383421|OG002|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
11064955|NCT01383421|EG000|Reported Event|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
11064956|NCT01383486|BG000|Baseline|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
11064957|NCT01383486|FG000|Participant Flow|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
11064958|NCT01383486|OG000|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
11064959|NCT01383486|OG000|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
11064960|NCT01383486|EG000|Reported Event|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
11064961|NCT01383499|BG000|Baseline|Total.|Total number of patients randomised and treated at all in the study.
11064962|NCT01383499|FG000|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Period 1, with Placebo in Period 2 and with Tiotropium 1.25 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
11064963|NCT01383499|FG001|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Period 1, with Tiotropium 5 mcg in Period 2 and with Tiotropium 2.5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
11064964|NCT01383499|FG002|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with Placebo in Period 1, with Tiotropium 2.5 mcg in Period 2 and with Tiotropium 5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
11064965|NCT01383499|FG003|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Period 1, with Tiotropium 1.25 mcg in Period 2 and with Placebo in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
11064966|NCT01383499|OG000|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064967|NCT01383499|OG001|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064968|NCT01383499|OG002|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064969|NCT01383499|OG003|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064970|NCT01383499|OG001|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064971|NCT01383499|OG002|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064972|NCT01383499|OG003|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064973|NCT01383499|EG000|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064974|NCT01383499|EG001|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064975|NCT01383499|EG002|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064976|NCT01383499|EG003|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
11064977|NCT01383616|BG000|Baseline|Unipedicular Kyphoplasty|In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
11064978|NCT01383616|BG001|Baseline|Bipedicular Kyphoplasty Group|In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
11064979|NCT01383616|BG002|Baseline|Total|Total of all reporting groups
11064980|NCT01383616|FG000|Participant Flow|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
11064981|NCT01383616|FG001|Participant Flow|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
11064982|NCT01383616|OG000|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
11066958|NCT01394510|EG000|Reported Event|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
11066959|NCT01394523|BG000|Baseline|Caudal Epidural|"The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.~Bupivacaine: 0.25% or 0.5%"
11064983|NCT01383616|OG001|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
11064984|NCT01383616|OG000|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered deliver bone cement.~A guidewire was placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
11064985|NCT01383616|OG000|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.~A guidewire was placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
11064986|NCT01383616|OG001|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
11064987|NCT01383616|OG000|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
11064988|NCT01383616|EG000|Reported Event|Unipedicular Kyphoplasty|Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
11064989|NCT01383616|EG001|Reported Event|Bipedicular Kyphoplasty Group|Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
11066960|NCT01394523|BG001|Baseline|Rectus Sheath|"The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.~Bupivacaine: 0.25% or 0.5%"
11066961|NCT01394523|BG002|Baseline|Local|"The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.~Bupivacaine: 0.25% or 0.5%"
11066962|NCT01394523|BG003|Baseline|Total|Total of all reporting groups
11066963|NCT01394523|FG000|Participant Flow|Caudal Epidural|"The caudal epidural block was delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.~Bupivacaine: 0.25% or 0.5%"
11064990|NCT01383707|BG000|Baseline|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
11064991|NCT01383707|FG000|Participant Flow|Bevacizumab + Modified FOLFOX-6 (mFOLFOX-6)|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
11064992|NCT01383707|OG000|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
11064993|NCT01383707|EG000|Reported Event|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
11064994|NCT01383720|BG000|Baseline|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
11064995|NCT01383720|FG000|Participant Flow|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
11064996|NCT01383720|OG000|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
11064997|NCT01383720|EG000|Reported Event|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
11064998|NCT01383759|BG000|Baseline|Amyloidosis|Participants with newly diagnosed AL amyloidosis
11064999|NCT01383759|BG001|Baseline|Monoclonal Ig DepositionDisease (MIDD)|Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
11065000|NCT01383759|BG002|Baseline|Total|Total of all reporting groups
11065001|NCT01383759|FG000|Participant Flow|Amyloidosis|Participants with newly diagnosed AL amyloidosis
11065002|NCT01383759|FG001|Participant Flow|Monoclonal Ig DepositionDisease (MIDD)|Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
11065003|NCT01383759|OG000|Outcome|Amyloidosis|Participants with newly diagnosed AL amyloidosis
11065004|NCT01383759|OG001|Outcome|Monoclonal Ig DepositionDisease (MIDD)|Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
11065005|NCT01383759|EG000|Reported Event|Amyloidosis|Participants with newly diagnosed AL amyloidosis
11065006|NCT01383759|EG001|Reported Event|Monoclonal Ig DepositionDisease (MIDD)|Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
11065007|NCT01383928|BG000|Baseline|Phase 1: Ixazomib 3 mg|Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
11066964|NCT01394523|FG001|Participant Flow|Rectus Sheath|"The rectus sheath block was performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.~Bupivacaine: 0.25% or 0.5%"
11066965|NCT01394523|FG002|Participant Flow|Local|"The surgeon injected either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.~Bupivacaine: 0.25% or 0.5%"
11065008|NCT01383928|BG001|Baseline|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
11065009|NCT01383928|BG002|Baseline|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).
11065010|NCT01383928|BG003|Baseline|Total|Total of all reporting groups
11065011|NCT01383928|FG000|Participant Flow|Phase 1: Ixazomib 3 mg|Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
11065012|NCT01383928|FG001|Participant Flow|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
11065013|NCT01383928|FG002|Participant Flow|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).
11065014|NCT01383928|OG000|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
11065015|NCT01383928|OG000|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
11065016|NCT01383928|OG001|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
11066966|NCT01394523|OG000|Outcome|Caudal Epidural|"The caudal epidural block was delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.~Bupivacaine: 0.25% or 0.5%"
11065017|NCT01383928|OG000|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).
11065018|NCT01383928|OG000|Outcome|Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 83 cycles (approximately 2037 days).
11065019|NCT01383928|EG000|Reported Event|Phase 1: Ixazomib 3 mg|Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
11065020|NCT01383928|EG001|Reported Event|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
11065021|NCT01383928|EG002|Reported Event|Phase 2: Ixazomib 3.0 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).
11065022|NCT01383954|BG000|Baseline|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
11065023|NCT01383954|FG000|Participant Flow|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
11065024|NCT01383954|OG000|Outcome|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
11065025|NCT01383954|EG000|Reported Event|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
11065026|NCT01383993|BG000|Baseline|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065027|NCT01383993|BG001|Baseline|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065028|NCT01383993|BG002|Baseline|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065029|NCT01383993|BG003|Baseline|Total|Total of all reporting groups
11066967|NCT01394523|OG001|Outcome|Rectus Sheath|"The rectus sheath block was performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.~Bupivacaine: 0.25% or 0.5%"
11065030|NCT01383993|FG000|Participant Flow|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065031|NCT01383993|FG001|Participant Flow|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065032|NCT01383993|FG002|Participant Flow|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065033|NCT01383993|OG000|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065034|NCT01383993|OG001|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065035|NCT01383993|OG002|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065036|NCT01383993|OG000|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065037|NCT01383993|EG000|Reported Event|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065038|NCT01383993|EG001|Reported Event|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065039|NCT01383993|EG002|Reported Event|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
11065040|NCT01384019|BG000|Baseline|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
11065041|NCT01384019|BG001|Baseline|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
11065042|NCT01384019|BG002|Baseline|Total|Total of all reporting groups
11065043|NCT01384019|FG000|Participant Flow|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
11065044|NCT01384019|FG001|Participant Flow|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
11065045|NCT01384019|OG000|Outcome|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
11065046|NCT01384019|OG001|Outcome|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
11065047|NCT01384019|EG000|Reported Event|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
11065048|NCT01384019|EG001|Reported Event|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
11065049|NCT01384292|BG000|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
11065050|NCT01384292|BG001|Baseline|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
11065051|NCT01384292|BG002|Baseline|Placebo|Placebo, oral treatment
11065052|NCT01384292|BG003|Baseline|Total|Total of all reporting groups
11065053|NCT01384292|FG000|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
11065054|NCT01384292|FG001|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
11065055|NCT01384292|FG002|Participant Flow|Placebo|Placebo, oral treatment
11065056|NCT01384292|OG000|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
11065057|NCT01384292|OG001|Outcome|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
11065058|NCT01384292|OG002|Outcome|Placebo|Placebo, oral treatment
11065059|NCT01384292|EG000|Reported Event|NKTR-118 12.5 mg - Part A|Part A NKTR-118 12.5 mg, oral treatment
11065060|NCT01384292|EG001|Reported Event|NKTR-118 25 mg - Part A|Part A NKTR-118 25 mg, oral treatment
11065061|NCT01384292|EG002|Reported Event|Placebo - Part A|Part A Placebo, oral treatment
11065062|NCT01384292|EG003|Reported Event|NKTR-118 12.5 mg - Part B|Part B NKTR-118 12.5 mg, oral treatment
11065063|NCT01384292|EG004|Reported Event|NKTR-118 25 mg - Part B|Part B NKTR-118 25 mg, oral treatment
11065064|NCT01384539|BG000|Baseline|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months~Cholecalciferol"
11065065|NCT01384539|BG001|Baseline|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months~Calcitriol"
11065066|NCT01384539|BG002|Baseline|Total|Total of all reporting groups
11065067|NCT01384539|FG000|Participant Flow|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months~Cholecalciferol"
11065068|NCT01384539|FG001|Participant Flow|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months~Calcitriol"
11065069|NCT01384539|OG000|Outcome|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months~Cholecalciferol"
11065070|NCT01384539|OG001|Outcome|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months~Calcitriol"
11065071|NCT01384539|EG000|Reported Event|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months~Cholecalciferol"
11065072|NCT01384539|EG001|Reported Event|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months~Calcitriol"
11065073|NCT01384591|BG000|Baseline|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065074|NCT01384591|BG001|Baseline|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065075|NCT01384591|BG002|Baseline|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065076|NCT01384591|BG003|Baseline|Total|Total of all reporting groups
11065077|NCT01384591|FG000|Participant Flow|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065078|NCT01384591|FG001|Participant Flow|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065079|NCT01384591|FG002|Participant Flow|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065080|NCT01384591|OG000|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065081|NCT01384591|OG001|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065082|NCT01384591|OG002|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065083|NCT01384591|EG000|Reported Event|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065084|NCT01384591|EG001|Reported Event|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
11066968|NCT01394523|OG002|Outcome|Local|"The surgeon injected either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.~Bupivacaine: 0.25% or 0.5%"
11065085|NCT01384591|EG002|Reported Event|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
11065086|NCT01384734|BG000|Baseline|FTR 400 mg BID/RAL/TDF|Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).
11065087|NCT01384734|BG001|Baseline|FTR 800 mg BID/RAL/TDF|Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065088|NCT01384734|BG002|Baseline|FTR 600 mg QD/RAL/TDF|Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065089|NCT01384734|BG003|Baseline|FTR 1200 mg QD/RAL/TDF|Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065090|NCT01384734|BG004|Baseline|ATV/r/RAL/TDF|Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
11065091|NCT01384734|BG005|Baseline|Total|Total of all reporting groups
11065092|NCT01384734|FG000|Participant Flow|FTR 400 mg BID/RAL/TDF|Participants were randomized and administered 400 milligrams (mg) FTR twice daily (BID) (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).
11065093|NCT01384734|FG001|Participant Flow|FTR 800 mg BID/RAL/TDF|Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065094|NCT01384734|FG002|Participant Flow|FTR 600 mg QD/RAL/TDF|Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065095|NCT01384734|FG003|Participant Flow|FTR 1200 mg QD/RAL/TDF|Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065096|NCT01384734|FG004|Participant Flow|ATV/r/RAL/TDF|Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
11065097|NCT01384734|OG000|Outcome|FTR 400 mg BID/RAL/TDF|Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).
11065098|NCT01384734|OG001|Outcome|FTR 800 mg BID/RAL/TDF|Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065099|NCT01384734|OG002|Outcome|FTR 600 mg QD/RAL/TDF|Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065100|NCT01384734|OG003|Outcome|FTR 1200 mg QD/RAL/TDF|Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065101|NCT01384734|OG004|Outcome|ATV/r/RAL/TDF|Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
11065102|NCT01384734|EG000|Reported Event|FTR/RAL/TDF Total|All participants who were randomized to receive either of FTR 400mg BID, 800 mg BID, 600mg QD or 1200 mg QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
11065103|NCT01384734|EG001|Reported Event|ATV/r/RAL/TDF|Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
11065104|NCT01384760|BG000|Baseline|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
11065105|NCT01384760|BG001|Baseline|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
11065106|NCT01384760|BG002|Baseline|Total|Total of all reporting groups
11065107|NCT01384760|FG000|Participant Flow|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
11065108|NCT01384760|FG001|Participant Flow|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
11065109|NCT01384760|OG000|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
11065110|NCT01384760|OG001|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
11065111|NCT01384760|EG000|Reported Event|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
11065112|NCT01384760|EG001|Reported Event|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
11065113|NCT01384877|BG000|Baseline|Lidocaine/Placebo|"Patient received Lidocaine in the first period followed by placebo in the second period.~Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours~Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs"
11065114|NCT01384877|BG001|Baseline|Placebo (D5W)/Lidocaine|"Patient received Placebo in the first period followed by Lidocaine in the second period.~Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs~Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours"
11065115|NCT01384877|BG002|Baseline|Total|Total of all reporting groups
11065116|NCT01384877|FG000|Participant Flow|Lidocaine/Placebo|"Patient received Lidocaine in the first period followed by placebo in the second period.~Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours~Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs"
11065117|NCT01384877|FG001|Participant Flow|Placebo (D5W)/Lidocaine|"Patient received Placebo in the first period followed by Lidocaine in the second period.~Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs~Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours"
11065118|NCT01384877|OG000|Outcome|Lidocaine/Placebo|"Patient received Lidocaine in the first period followed by placebo in the second period.~Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours~Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs"
11065119|NCT01384877|OG001|Outcome|Placebo (D5W)/Lidocaine|"Patient received Placebo in the first period followed by Lidocaine in the second period.~Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs~Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours"
11065120|NCT01384877|EG000|Reported Event|Lidocaine|"Lidocaine~Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours"
11065121|NCT01384877|EG001|Reported Event|Placebo (D5W)|"Placebo first as compared with lidocaine first~Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)"
11065122|NCT01385098|BG000|Baseline|Vitamin D3 and Calcium|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
11065123|NCT01385098|FG000|Participant Flow|Vitamin D3 and Calcium|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
11065124|NCT01385098|OG000|Outcome|Vitamin D3 and Calcium|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
11065125|NCT01385098|OG000|Outcome|Sleeve Gastrectomy|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
11065126|NCT01385098|OG001|Outcome|Roux-Y Gastric Bypass|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
11065127|NCT01385098|EG000|Reported Event|Vitamin D3 and Calcium|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
11065128|NCT01385137|BG000|Baseline|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
11065129|NCT01385137|BG001|Baseline|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
11065130|NCT01385137|BG002|Baseline|Total|Total of all reporting groups
11065131|NCT01385137|FG000|Participant Flow|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
11065132|NCT01385137|FG001|Participant Flow|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
11065133|NCT01385137|OG000|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
11065134|NCT01385137|OG001|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
11065135|NCT01385137|EG000|Reported Event|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
11065136|NCT01385137|EG001|Reported Event|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
11065137|NCT01385189|BG000|Baseline|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
11065138|NCT01385189|BG001|Baseline|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
11065139|NCT01385189|BG002|Baseline|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
11065140|NCT01385189|BG003|Baseline|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
11065141|NCT01385189|BG004|Baseline|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
11065142|NCT01385189|BG005|Baseline|Total|Total of all reporting groups
11065143|NCT01385189|FG000|Participant Flow|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
11065144|NCT01385189|FG001|Participant Flow|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
11065145|NCT01385189|FG002|Participant Flow|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
11065146|NCT01385189|FG003|Participant Flow|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
11065147|NCT01385189|FG004|Participant Flow|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
11065148|NCT01385189|OG000|Outcome|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
11065149|NCT01385189|OG001|Outcome|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
11065150|NCT01385189|OG002|Outcome|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
11065151|NCT01385189|OG003|Outcome|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
11065152|NCT01385189|OG004|Outcome|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
11065153|NCT01385189|OG000|Outcome|10 μg Na-GST-1/Alhydrogel|
11065154|NCT01385189|OG001|Outcome|10 µg Na-GST-1/Alhydrogel/GLA-AF (1 µg)|
11065155|NCT01385189|OG002|Outcome|30 µg Na-GST-1/Alhydrogel|
11065156|NCT01385189|OG003|Outcome|30 µg Na-GST-1/Alhydrogel/GLA-AF (1 µg)|
11065157|NCT01385189|OG004|Outcome|30 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)|
11065158|NCT01385189|OG005|Outcome|100 µg Na-GST-1/Alhydrogel|
11065159|NCT01385189|OG006|Outcome|100 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)|
11065160|NCT01385189|EG000|Reported Event|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
11065161|NCT01385189|EG001|Reported Event|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
11065162|NCT01385189|EG002|Reported Event|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
11065163|NCT01385189|EG003|Reported Event|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
11065164|NCT01385189|EG004|Reported Event|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
11065165|NCT01385202|BG000|Baseline|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
11065166|NCT01385202|FG000|Participant Flow|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
11065167|NCT01385202|OG000|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
11065168|NCT01385202|OG000|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter-Effective Cohort|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter.
11065169|NCT01385202|OG001|Outcome|Calibration Roll-in|Calibration roll-in case(s) is intended to calibrate an investigator's tactile feel, catheter manipulation technique, and use of other surrogate measures (electrogram signal, impedance, etc.) during the procedure.
11065170|NCT01385202|EG000|Reported Event|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
11065171|NCT01385293|BG000|Baseline|BKM 120|BKM120 at 100mg orally daily
11065172|NCT01385293|FG000|Participant Flow|BKM 120|BKM120 at 100mg orally daily
11065173|NCT01385293|OG000|Outcome|BKM 120|BKM120 at 100mg orally daily
11065174|NCT01385293|EG000|Reported Event|BKM 120|BKM120 at 100mg orally daily
11065175|NCT01385306|BG000|Baseline|AlphaCore System: Non-invasive Neurostimulation|AlphaCore System: Non-invasive neurostimulation of the vagus nerve
11065176|NCT01385306|FG000|Participant Flow|AlphaCore System: Non-invasive Neurostimulation|AlphaCore System: Non-invasive neurostimulation of the vagus nerve
11065177|NCT01385306|OG000|Outcome|AlphaCore System: Non-invasive Neurostimulation|AlphaCore System: Non-invasive neurostimulation of the vagus nerve
11065178|NCT01385306|EG000|Reported Event|AlphaCore System: Non-invasive Neurostimulation|AlphaCore System: Non-invasive neurostimulation of the vagus nerve
11065179|NCT01385371|BG000|Baseline|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
11065180|NCT01385371|BG001|Baseline|Placebo|Participants receiving Placebo
11065181|NCT01385371|BG002|Baseline|Total|Total of all reporting groups
11065182|NCT01385371|FG000|Participant Flow|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
11065183|NCT01385371|FG001|Participant Flow|Placebo|Participants receiving Placebo
11065184|NCT01385371|OG000|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
11065185|NCT01385371|OG001|Outcome|Placebo|Participants receiving Placebo
11065186|NCT01385371|EG000|Reported Event|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
11065187|NCT01385371|EG001|Reported Event|Placebo|Participants receiving Placebo
11065188|NCT01385566|BG000|Baseline|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
11065189|NCT01385566|BG001|Baseline|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065190|NCT01385566|BG002|Baseline|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065191|NCT01385566|BG003|Baseline|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065192|NCT01385566|BG004|Baseline|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065193|NCT01385566|BG005|Baseline|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065194|NCT01385566|BG006|Baseline|Total|Total of all reporting groups
11065195|NCT01385566|FG000|Participant Flow|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
11065196|NCT01385566|FG001|Participant Flow|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065197|NCT01385566|FG002|Participant Flow|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065198|NCT01385566|FG003|Participant Flow|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11066969|NCT01394523|EG000|Reported Event|Caudal Epidural|"The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.~Bupivacaine: 0.25% or 0.5%"
11065199|NCT01385566|FG004|Participant Flow|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065200|NCT01385566|FG005|Participant Flow|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065201|NCT01385566|OG000|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
11065202|NCT01385566|OG001|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065203|NCT01385566|OG002|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065204|NCT01385566|OG003|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065205|NCT01385566|OG004|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065206|NCT01385566|OG005|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065207|NCT01385566|OG006|Outcome|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
11065208|NCT01385566|EG000|Reported Event|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
11065209|NCT01385566|EG001|Reported Event|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065210|NCT01385566|EG002|Reported Event|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065211|NCT01385566|EG003|Reported Event|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065212|NCT01385566|EG004|Reported Event|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065213|NCT01385566|EG005|Reported Event|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
11065214|NCT01385566|EG006|Reported Event|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Only injection-site adverse events occurring in the placebo limb are reported; systemic adverse events are reported by V211 treatment group only.
11065215|NCT01385579|BG000|Baseline|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
11065216|NCT01385579|BG001|Baseline|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
11065217|NCT01385579|BG002|Baseline|Total|Total of all reporting groups
11065218|NCT01385579|FG000|Participant Flow|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
11065219|NCT01385579|FG001|Participant Flow|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
11065220|NCT01385579|OG000|Outcome|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
11065221|NCT01385579|OG001|Outcome|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
11065222|NCT01385579|EG000|Reported Event|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
11065223|NCT01385579|EG001|Reported Event|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
11065224|NCT01385644|BG000|Baseline|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
11065225|NCT01385644|BG001|Baseline|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
11065226|NCT01385644|BG002|Baseline|Total|Total of all reporting groups
11065227|NCT01385644|FG000|Participant Flow|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
11065228|NCT01385644|FG001|Participant Flow|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
11065229|NCT01385644|OG000|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
11065230|NCT01385644|OG001|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
11065231|NCT01385644|EG000|Reported Event|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
11065232|NCT01385644|EG001|Reported Event|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
11065233|NCT01385696|BG000|Baseline|Overall Study Safety Population|All patients randomized into the study excluding 1 patient who used Handihaler® once only, Genuair® zero times, & was excluded from the safety population
11065234|NCT01385696|FG000|Participant Flow|Placebo Genuair (Daily) Then Placebo HandiHaler (Daily)|Each morning, patients used the Genuair® (Almirall S.A.) inhaler containing placebo followed by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo. The study period consisted of 1 period of 14 days.
11065235|NCT01385696|FG001|Participant Flow|Placebo HandiHaler (Daily) Then Placebo Genuair (Daily)|Each morning, patients used the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo followed by the Genuair® (Almirall S.A.) inhaler containing placebo. The study period consisted of 1 period of 14 days.
11065236|NCT01385696|OG000|Outcome|Overall Intention-to-treat Population|Overall intention-to-treat (ITT) population
11065237|NCT01385696|OG000|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
11065238|NCT01385696|OG001|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
11065239|NCT01385696|EG000|Reported Event|Genuair Then HandiHaler|The study period consisted of 1 period of 14 days. Every morning patients used the Genuair® (Almirall S.A.) inhaler containing placebo follow by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo.
11065240|NCT01385696|EG001|Reported Event|HandiHaler Then Genuair|The study period consisted of 1 period of 14 days. Every morning patients used the HandiHaler® (Boehringer Ingelheim)inhaler containing placebo follow by the Genuair® (Almirall S.A.) inhaler containing placebo.
11065241|NCT01385748|BG000|Baseline|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
11065242|NCT01385748|BG001|Baseline|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
11065243|NCT01385748|BG002|Baseline|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
11065244|NCT01385748|BG003|Baseline|Total|Total of all reporting groups
11065245|NCT01385748|FG000|Participant Flow|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
11065246|NCT01385748|FG001|Participant Flow|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
11065247|NCT01385748|FG002|Participant Flow|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
11065248|NCT01385748|OG000|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
11065249|NCT01385748|OG001|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
11065250|NCT01385748|OG002|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
11065251|NCT01385748|OG003|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
11065252|NCT01385748|OG000|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
11065253|NCT01385748|OG001|Outcome|Clonidine Lauriad® 100µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
11065254|NCT01385748|EG000|Reported Event|Clonidine Lauriad® 50µg|Clonidine Lauriad® 50µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
11065255|NCT01385748|EG001|Reported Event|Clonidine Lauriad® 100µg|Clonidine Lauriad® 100µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
11065256|NCT01385748|EG002|Reported Event|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
11065257|NCT01385748|EG003|Reported Event|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks
11065258|NCT01385995|BG000|Baseline|Continuous Positive Airway Pressure (CPAP)|
11065259|NCT01385995|BG001|Baseline|Sham-Continuous Positive Airway Pressure|
11065260|NCT01385995|BG002|Baseline|Total|Total of all reporting groups
11065261|NCT01385995|FG000|Participant Flow|Continuous Positive Airway Pressure (CPAP)|
11065262|NCT01385995|FG001|Participant Flow|Sham-Continuous Positive Airway Pressure|
11065263|NCT01385995|OG000|Outcome|Therapeutic CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.
11065264|NCT01385995|OG001|Outcome|Sham CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
11065265|NCT01385995|OG000|Outcome|Therapeutic CPAP|
11065266|NCT01385995|OG001|Outcome|Sham CPAP|
11065267|NCT01385995|EG000|Reported Event|Continuous Positive Airway Pressure (CPAP)|
11065268|NCT01385995|EG001|Reported Event|Sham-Continuous Positive Airway Pressure|
11065269|NCT01386008|BG000|Baseline|Overall Study Group|Participants wear one enfilcon A (test) contact lens in one eye and one senofilcon A (comparator) contact lens in the other. Both lenses are worn daily wear.
11065270|NCT01386008|FG000|Participant Flow|Overall Study Group|Participants wear one enfilcon A (test) contact lens in one eye and one senofilcon A (comparator) contact lens in the other. Both lenses are worn daily wear.
11065271|NCT01386008|OG000|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
11065272|NCT01386008|EG000|Reported Event|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
11065273|NCT01386528|BG000|Baseline|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator's discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
11065274|NCT01386528|FG000|Participant Flow|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator's discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
11066970|NCT01394523|EG001|Reported Event|Rectus Sheath|"The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.~Bupivacaine: 0.25% or 0.5%"
11066971|NCT01394523|EG002|Reported Event|Local|"The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.~Bupivacaine: 0.25% or 0.5%"
11065275|NCT01386528|OG000|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator's discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
11065276|NCT01386528|EG000|Reported Event|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator's discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
11065277|NCT01386554|BG000|Baseline|Acthar 40U|40 U of Acthar administered 5 times a week
11065278|NCT01386554|BG001|Baseline|Acthar 80U|80 U of Acthar administered 2 times a week
11065279|NCT01386554|BG002|Baseline|Combined Placbeo|Placebo (volume matched for 40 U or 80 U) administered 5 times (40 U) or 2 times (80 U) per week
11065280|NCT01386554|BG003|Baseline|Total|Total of all reporting groups
11065281|NCT01386554|FG000|Participant Flow|Acthar 40U|40 units (U) of Acthar administered 5 times a week
11065282|NCT01386554|FG001|Participant Flow|Acthar 80U|80 U of Acthar administered 2 times a week
11065283|NCT01386554|FG002|Participant Flow|Combined Placebo|Placebo (volume matched for 40 U or 80 U) administered 5 times (40 U) or 2 times (80 U) per week
11065284|NCT01386554|OG000|Outcome|Acthar 40U|40 U of Acthar administered 5 times a week
11065285|NCT01386554|OG001|Outcome|Acthar 80U|80 U of Acthar administered 2 times a week
11065286|NCT01386554|OG002|Outcome|Combined Placebo|Placebo (volume matched for 40 U or 80 U) administered 5 times (40 U) or 2 times (80 U) per week
11065287|NCT01386554|OG000|Outcome|Acthar 40U|40 units (U) of Acthar administered 5 times a week
11065288|NCT01386554|OG001|Outcome|Acthar 80U|80 units (U) of Acthar administered 2 times a week
11065289|NCT01386554|EG000|Reported Event|Acthar 40U|40 U of Acthar administered 5 times a week
11065290|NCT01386554|EG001|Reported Event|Acthar 80U|80 U of Acthar administered 2 times a week
11065291|NCT01386554|EG002|Reported Event|Combined Placebo|Placebo (volume matched for 40 U or 80 U) administered 5 times (40 U) or 2 times (80 U) per week
11065292|NCT01386606|BG000|Baseline|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065293|NCT01386606|BG001|Baseline|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065294|NCT01386606|BG002|Baseline|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065295|NCT01386606|BG003|Baseline|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
11065296|NCT01386606|BG004|Baseline|Total|Total of all reporting groups
11065297|NCT01386606|FG000|Participant Flow|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065298|NCT01386606|FG001|Participant Flow|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065299|NCT01386606|FG002|Participant Flow|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065300|NCT01386606|FG003|Participant Flow|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
11065301|NCT01386606|OG000|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065302|NCT01386606|OG001|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065303|NCT01386606|OG002|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065304|NCT01386606|OG003|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
11065305|NCT01386606|OG000|Outcome|Androxal Pooled Dose Levels|Androxal 6.25, 12.5, and 25 mg subjects combined into a single group.
11065306|NCT01386606|OG000|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
11065307|NCT01386606|OG001|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
11065308|NCT01386606|OG002|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
11065309|NCT01386606|EG000|Reported Event|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065310|NCT01386606|EG001|Reported Event|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065311|NCT01386606|EG002|Reported Event|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
11065312|NCT01386606|EG003|Reported Event|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
11065313|NCT01386632|BG000|Baseline|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
11065314|NCT01386632|BG001|Baseline|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
11065315|NCT01386632|BG002|Baseline|Total|Total of all reporting groups
11066972|NCT01394614|BG000|Baseline|Exposed Narcoleptic Subjects|Exposed (vaccinated and onset of narcolepsy is after vaccine administration) narcoleptic subjects to adjuvanted A/H1N1 vaccine
11065316|NCT01386632|FG000|Participant Flow|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
11065317|NCT01386632|FG001|Participant Flow|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
11065318|NCT01386632|OG000|Outcome|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
11065319|NCT01386632|OG001|Outcome|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
11065320|NCT01386632|EG000|Reported Event|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
11065321|NCT01386632|EG001|Reported Event|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
11065322|NCT01386645|BG000|Baseline|Low GI Diet|"low glycemic index diet~low glycemic index diet: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable low glycemic index diet (glycemic index <35) for 4 weeks with all food provided by the Human Nutrition Lab"
11065323|NCT01386645|BG001|Baseline|High GI Diet Placebo|"high glycemic index diet plus placebo~high glycemic index diet plus placebo: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take placebo capsules (matching for active N-acetylcysteine (NAC) in arm 3) twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded."
11065324|NCT01386645|BG002|Baseline|High GI Diet NAC|"high glycemic index diet plus N-acetylcysteine~high glycemic index diet plus N-acetylcysteine: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take N-acetylcysteine (NAC) two 600 mg capsules twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded."
11065325|NCT01386645|BG003|Baseline|Total|Total of all reporting groups
11065326|NCT01386645|FG000|Participant Flow|Low GI Diet|"low glycemic index diet~low glycemic index diet: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable low glycemic index diet (glycemic index <35) for 4 weeks with all food provided by the Human Nutrition Lab"
11065327|NCT01386645|FG001|Participant Flow|High GI Diet Placebo|"high glycemic index diet plus placebo~high glycemic index diet plus placebo: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take placebo capsules (matching for active N-acetylcysteine (NAC) in arm 3) twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded."
11065328|NCT01386645|FG002|Participant Flow|High GI Diet NAC|"high glycemic index diet plus N-acetylcysteine~high glycemic index diet plus N-acetylcysteine: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take N-acetylcysteine (NAC) two 600 mg capsules twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded."
11065329|NCT01386645|OG000|Outcome|Low GI Diet|"low glycemic index diet~low glycemic index diet: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable low glycemic index diet (glycemic index <35) for 4 weeks with all food provided by the Human Nutrition Lab"
11065330|NCT01386645|OG001|Outcome|High GI Diet Placebo|"high glycemic index diet plus placebo~high glycemic index diet plus placebo: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take placebo capsules (matching for active N-acetylcysteine (NAC) in arm 3) twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded."
11065331|NCT01386645|OG002|Outcome|High GI Diet NAC|"high glycemic index diet plus N-acetylcysteine~high glycemic index diet plus N-acetylcysteine: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take N-acetylcysteine (NAC) two 600 mg capsules twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded."
11065332|NCT01386645|EG000|Reported Event|Low GI Diet|"low glycemic index diet~low glycemic index diet: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable low glycemic index diet (glycemic index <35) for 4 weeks with all food provided by the Human Nutrition Lab"
11065333|NCT01386645|EG001|Reported Event|High GI Diet Placebo|"high glycemic index diet plus placebo~high glycemic index diet plus placebo: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take placebo capsules (matching for active N-acetylcysteine (NAC) in arm 3) twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded."
11065334|NCT01386645|EG002|Reported Event|High GI Diet NAC|"high glycemic index diet plus N-acetylcysteine~high glycemic index diet plus N-acetylcysteine: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take N-acetylcysteine (NAC) two 600 mg capsules twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded."
11065335|NCT01386788|BG000|Baseline|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
11065336|NCT01386788|FG000|Participant Flow|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
11065337|NCT01386788|OG000|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
11065338|NCT01386788|EG000|Reported Event|Smoke Inhalation Victim|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed
11065339|NCT01386944|BG000|Baseline|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
11065340|NCT01386944|FG000|Participant Flow|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
11065341|NCT01386944|OG000|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
11065342|NCT01386944|EG000|Reported Event|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
11065343|NCT01386970|BG000|Baseline|HIV-negative|"This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.~zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group"
11065344|NCT01386970|BG001|Baseline|HIV-infected|"This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.~zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group"
11065345|NCT01386970|BG002|Baseline|Total|Total of all reporting groups
11065346|NCT01386970|FG000|Participant Flow|HIV-negative|"This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.~zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group"
11065347|NCT01386970|FG001|Participant Flow|HIV-infected|"This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.~zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group"
11065348|NCT01386970|OG000|Outcome|HIV-negative|"This group was used to compare intracellular ZDV-triphosphate concentrations to the HIV-infected group~zidovudine 300mg twice daily for 12 days in the HIV-negative group"
11065349|NCT01386970|OG001|Outcome|HIV-infected|"This group was used to compare intracellular ZDV-triphosphate concentrations to the HIV-infected group~zidovudine 300mg twice daily for 12 days in the HIV-negative group"
11065350|NCT01386970|OG000|Outcome|HIV-negative|"This group was used to measure intracellular 3TC-triphosphate concentrations in those who are HIV-negative~lamivudine 150mg twice daily for 12 days in the HIV-negative group"
11065351|NCT01386970|OG001|Outcome|HIV-infected|"This group was used to measure intracellular 3TC-triphosphate concentrations in those who are HIV-positive~lamivudine 150mg twice daily indefinitely for their care in the HIV-positive group"
11065352|NCT01386970|EG000|Reported Event|HIV-negative|"This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.~zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group"
11065353|NCT01386970|EG001|Reported Event|HIV-infected|"This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.~zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group"
11065354|NCT01386983|BG000|Baseline|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
11065355|NCT01386983|BG001|Baseline|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
11065356|NCT01386983|BG002|Baseline|Total|Total of all reporting groups
11065357|NCT01386983|FG000|Participant Flow|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
11065358|NCT01386983|FG001|Participant Flow|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
11065359|NCT01386983|OG000|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
11065360|NCT01386983|OG001|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
11065361|NCT01386983|EG000|Reported Event|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
11065362|NCT01386983|EG001|Reported Event|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
11065363|NCT01387022|BG000|Baseline|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
11065364|NCT01387022|BG001|Baseline|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
11065365|NCT01387022|BG002|Baseline|Total|Total of all reporting groups
11065366|NCT01387022|FG000|Participant Flow|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
11065367|NCT01387022|FG001|Participant Flow|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
11065368|NCT01387022|OG000|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
11065369|NCT01387022|OG001|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
11065370|NCT01387022|EG000|Reported Event|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
11065371|NCT01387022|EG001|Reported Event|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
11065372|NCT01387074|BG000|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
11065373|NCT01387074|FG000|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
11065374|NCT01387074|OG000|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
11065375|NCT01387074|EG000|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
11065376|NCT01387139|BG000|Baseline|Ketamine Alone|
11065377|NCT01387139|BG001|Baseline|Ketamine Co-Administered With Propofol|
11065378|NCT01387139|BG002|Baseline|Total|Total of all reporting groups
11065379|NCT01387139|FG000|Participant Flow|Ketamine Alone|Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
11065380|NCT01387139|FG001|Participant Flow|Ketamine Co-Administered With Propofol|Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
11065381|NCT01387139|OG000|Outcome|Ketamine Alone|
11065382|NCT01387139|OG001|Outcome|Ketamine Co-Administered With Propofol|
11065383|NCT01387139|EG000|Reported Event|Ketamine Alone|
11065384|NCT01387139|EG001|Reported Event|Ketamine Co-Administered With Propofol|
11065385|NCT01387178|BG000|Baseline|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
11065386|NCT01387178|BG001|Baseline|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
11065387|NCT01387178|BG002|Baseline|Total|Total of all reporting groups
11065388|NCT01387178|FG000|Participant Flow|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Edition, Clinical Modification [ICD-9-CM] code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for fluticasone/propionate 250 µg /50 µg (FSC)
11065389|NCT01387178|FG001|Participant Flow|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for tiotropium bromide (TIO)
11065390|NCT01387178|OG000|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
11065391|NCT01387178|OG001|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
11065392|NCT01387178|OG001|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
11065393|NCT01387178|EG000|Reported Event|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
11065394|NCT01387178|EG001|Reported Event|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
11065395|NCT01387230|BG000|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
11065396|NCT01387230|BG001|Baseline|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
11065397|NCT01387230|BG002|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11065398|NCT01387230|BG003|Baseline|Total|Total of all reporting groups
11065399|NCT01387230|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12 weeks.
11065400|NCT01387230|FG001|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
11065401|NCT01387230|FG002|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11065402|NCT01387230|OG000|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
11065403|NCT01387230|OG001|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
11065404|NCT01387230|OG002|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11065405|NCT01387230|EG000|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
11065406|NCT01387230|EG001|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
11065407|NCT01387230|EG002|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
11065408|NCT01387269|BG000|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065409|NCT01387269|BG001|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065410|NCT01387269|BG002|Baseline|Total|Total of all reporting groups
11065411|NCT01387269|FG000|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065412|NCT01387269|FG001|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065413|NCT01387269|OG000|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065414|NCT01387269|OG001|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065415|NCT01387269|EG000|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065416|NCT01387269|EG001|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065417|NCT01387282|BG000|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065418|NCT01387282|BG001|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065419|NCT01387282|BG002|Baseline|Total|Total of all reporting groups
11065420|NCT01387282|FG000|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065421|NCT01387282|FG001|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065422|NCT01387282|OG000|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065423|NCT01387282|OG001|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065424|NCT01387282|EG000|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065425|NCT01387282|EG001|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11065426|NCT01387347|BG000|Baseline|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
11065427|NCT01387347|BG001|Baseline|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
11065428|NCT01387347|BG002|Baseline|Total|Total of all reporting groups
11065429|NCT01387347|FG000|Participant Flow|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
11065430|NCT01387347|FG001|Participant Flow|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4.~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
11065431|NCT01387347|OG000|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
11065432|NCT01387347|OG001|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0% Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
11065433|NCT01387347|OG000|Outcome|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
11065434|NCT01387347|OG001|Outcome|Thymosin Beta 4|Thymosin beta 4 solution is a sterile eye drop solution containing 0.1%(w/w) Tβ4. Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
11065435|NCT01387347|OG000|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 (w/w) for direct instillation into each eye twice a day for 29 days.
11065436|NCT01387347|OG001|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye twice a day for 29 days.
11065437|NCT01387347|EG000|Reported Event|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
11065438|NCT01387347|EG001|Reported Event|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
11065439|NCT01387464|BG000|Baseline|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
11065440|NCT01387464|BG001|Baseline|Bromday|0.09% bromfenac dosed QD
11065441|NCT01387464|BG002|Baseline|Total|Total of all reporting groups
11065442|NCT01387464|FG000|Participant Flow|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
11065443|NCT01387464|FG001|Participant Flow|Bromday|0.09% bromfenac dosed QD
11065444|NCT01387464|OG000|Outcome|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
11065445|NCT01387464|OG001|Outcome|Bromday|0.09% bromfenac dosed QD
11065446|NCT01387464|EG000|Reported Event|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
11065447|NCT01387464|EG001|Reported Event|Bromday|0.09% bromfenac dosed QD
11065448|NCT01387516|BG000|Baseline|Motivational Intervention/Cognitive Behavioral Therapy|Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
11065449|NCT01387516|BG001|Baseline|Motivational Intervention/Self-Help Programming|Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Self Help Intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
11065450|NCT01387516|BG002|Baseline|Relaxation Intervention/Cognitive Behavioral Therapy|The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
11065451|NCT01387516|BG003|Baseline|Relaxation Intervention/ Self-Help Programming|The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Self Help intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
11065452|NCT01387516|BG004|Baseline|Total|Total of all reporting groups
11065453|NCT01387516|FG000|Participant Flow|Motivational Intervention/Cognitive Behavioral Therapy|Motivational Intervention (MI) is one 60-90 minute individual session focusing on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focusing on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
11065454|NCT01387516|FG001|Participant Flow|Motivational Interviewing/Self-Help Programming|"Motivational Intervention (MI) is one 60-90 minute individual session focusing on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy. This is followed by two 90 minute group Self Help intervention sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. Elements incorporated in this intervention include the 12 Steps and the NicA tools (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine."
11065455|NCT01387516|FG002|Participant Flow|Relaxation Intervention/Cognitive Behavioral Therapy|The Relaxation Therapy intervention one 60-90 minute individual session that encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focusings on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
11065456|NCT01387516|FG003|Participant Flow|Relaxation Intervention/Self-Help Programming|"The Relaxation Therapy intervention is one 60-90 minute individual session that encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute group sessions of Self Help intervention, based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. Elements incorporated in this intervention include the 12 Steps and the NicA tools (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine."
11065457|NCT01387516|OG000|Outcome|Motivational Interviewing/ Cognitive Behavioral Therapy|Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking
11065458|NCT01387516|OG001|Outcome|Motivational Interviewing/Self Help Programming|Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Self Help Intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
11065459|NCT01387516|OG002|Outcome|Relaxation Intervention/Cognitive Behavioral Therapy|The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
11065460|NCT01387516|OG003|Outcome|Relaxation Intervention/Self Help Programming|The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Self Help intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
11065461|NCT01387516|EG000|Reported Event|Motivational Intervention/Cognitive Behavioral Therapy|Motivational Intervention (MI) is one 60-90 minute individual session focusing on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focusing on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
11065462|NCT01387516|EG001|Reported Event|Motivational Interviewing/Self-Help Programming|"Motivational Intervention (MI) is one 60-90 minute individual session focusing on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy. This is followed by two 90 minute group Self Help intervention sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. Elements incorporated in this intervention include the 12 Steps and the NicA tools (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine."
11065463|NCT01387516|EG002|Reported Event|Relaxation Intervention/Cognitive Behavioral Therapy|The Relaxation Therapy intervention one 60-90 minute individual session that encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focusings on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
11065464|NCT01387516|EG003|Reported Event|Relaxation Intervention/Self-Help Programming|"The Relaxation Therapy intervention is one 60-90 minute individual session that encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute group sessions of Self Help intervention, based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. Elements incorporated in this intervention include the 12 Steps and the NicA tools (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine."
11065465|NCT01387542|BG000|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
11065466|NCT01387542|FG000|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
11065467|NCT01387542|OG000|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
11065468|NCT01387542|EG000|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
11065469|NCT01387581|BG000|Baseline|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
11065470|NCT01387581|BG001|Baseline|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
11065471|NCT01387581|BG002|Baseline|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
11065472|NCT01387581|BG003|Baseline|Total|Total of all reporting groups
11065473|NCT01387581|FG000|Participant Flow|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
11065474|NCT01387581|FG001|Participant Flow|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
11065475|NCT01387581|FG002|Participant Flow|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
11065476|NCT01387581|OG000|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
11065477|NCT01387581|OG001|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
11065478|NCT01387581|OG002|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
11065479|NCT01387581|EG000|Reported Event|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
11065480|NCT01387581|EG001|Reported Event|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
11065481|NCT01387581|EG002|Reported Event|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
11065482|NCT01387594|BG000|Baseline|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065483|NCT01387594|BG001|Baseline|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065484|NCT01387594|BG002|Baseline|Total|Total of all reporting groups
11065485|NCT01387594|FG000|Participant Flow|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065486|NCT01387594|FG001|Participant Flow|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065487|NCT01387594|OG000|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065488|NCT01387594|OG000|Outcome|Cohort 1: PF-00547659|Participants who had CD and who satisfied all study entry criteria were enrolled into the study. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). 2 LPs were to be performed during participation. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065489|NCT01387594|OG001|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065490|NCT01387594|OG000|Outcome|Cohort 1: PF-00547659|Participants who had Crohns disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065491|NCT01387594|OG000|Outcome|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11066973|NCT01394614|BG001|Baseline|Unexposed Narcoleptic Subjects|Unexposed (non-vaccinated or vaccinated after onset of symptoms) narcoleptic subjects to adjuvanted A/H1N1 vaccine
11066974|NCT01394614|BG002|Baseline|Total|Total of all reporting groups
11065492|NCT01387594|EG000|Reported Event|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065493|NCT01387594|EG001|Reported Event|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
11065494|NCT01387607|BG000|Baseline|Pregabalin|"Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase.~Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening."
11065495|NCT01387607|BG001|Baseline|Placebo|"Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.~Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level."
11065496|NCT01387607|BG002|Baseline|Total|Total of all reporting groups
11065497|NCT01387607|FG000|Participant Flow|Pregabalin|"Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase.~Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening."
11065498|NCT01387607|FG001|Participant Flow|Placebo|"Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.~Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level."
11065499|NCT01387607|OG000|Outcome|Pregabalin|"Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase.~Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening."
11065500|NCT01387607|OG001|Outcome|Placebo|"Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.~Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level."
11065501|NCT01387607|EG000|Reported Event|Pregabalin|"Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase.~Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening."
11065502|NCT01387607|EG001|Reported Event|Placebo|"Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.~Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level."
11065503|NCT01387672|BG000|Baseline|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
11065504|NCT01387672|BG001|Baseline|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
11065505|NCT01387672|BG002|Baseline|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
11065506|NCT01387672|BG003|Baseline|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
11065507|NCT01387672|BG004|Baseline|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
11065508|NCT01387672|BG005|Baseline|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
11065509|NCT01387672|BG006|Baseline|Total|Total of all reporting groups
11065510|NCT01387672|FG000|Participant Flow|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
11065511|NCT01387672|FG001|Participant Flow|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
11065512|NCT01387672|FG002|Participant Flow|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
11065513|NCT01387672|FG003|Participant Flow|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
11065514|NCT01387672|FG004|Participant Flow|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
11065515|NCT01387672|FG005|Participant Flow|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Nitrates (NABT Main trial)"
11065516|NCT01387672|OG000|Outcome|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
11065517|NCT01387672|OG001|Outcome|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
11065518|NCT01387672|OG002|Outcome|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
11065519|NCT01387672|OG003|Outcome|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
11065520|NCT01387672|OG004|Outcome|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
11065521|NCT01387672|OG005|Outcome|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
11065522|NCT01387672|OG000|Outcome|Run-in Phase|During the run-in phase subjects received, in random order, each of the 5 nitrate formulations for 2 days with a 2 day wash out period between formulations. The severity of headaches was recorded, by subjects, upon awakening, every day during the run in phase using a visual analog scale (VAS).
11065523|NCT01387672|EG000|Reported Event|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
11065524|NCT01387672|EG001|Reported Event|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
11065525|NCT01387672|EG002|Reported Event|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
11065526|NCT01387672|EG003|Reported Event|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
11065527|NCT01387672|EG004|Reported Event|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
11065528|NCT01387672|EG005|Reported Event|Placebo Ointment- Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
11065529|NCT01387737|BG000|Baseline|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
11065530|NCT01387737|BG001|Baseline|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
11065531|NCT01387737|BG002|Baseline|Total|Total of all reporting groups
11065532|NCT01387737|FG000|Participant Flow|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
11065533|NCT01387737|FG001|Participant Flow|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
11065534|NCT01387737|OG000|Outcome|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
11065535|NCT01387737|OG001|Outcome|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
11065536|NCT01387737|EG000|Reported Event|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
11065537|NCT01387737|EG001|Reported Event|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
11065538|NCT01387789|BG000|Baseline|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
11065539|NCT01387789|FG000|Participant Flow|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
11065540|NCT01387789|OG000|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
11065541|NCT01387789|EG000|Reported Event|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
11065542|NCT01387815|BG000|Baseline|Topical/Traditional Systemic Agent|Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.
11065543|NCT01387815|BG001|Baseline|Adalimumab|Participants treated with adalimumab alone or in combination with topical agents.
11065544|NCT01387815|BG002|Baseline|Total|Total of all reporting groups
11065545|NCT01387815|FG000|Participant Flow|Topical/Traditional Systemic Agent|Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.
11065546|NCT01387815|FG001|Participant Flow|Adalimumab|Participants treated with adalimumab alone or in combination with topical agents.
11065547|NCT01387815|OG000|Outcome|Topical/Traditional Systemic Agent|Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.
11065548|NCT01387815|OG001|Outcome|Adalimumab|Participants treated with adalimumab alone or in combination with topical agents.
11065549|NCT01387815|EG000|Reported Event|Topical/Traditional|Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.
11065550|NCT01387815|EG001|Reported Event|Adalimumab|Participants treated with adalimumab alone or in combination with topical agents.
11065551|NCT01387932|BG000|Baseline|HepaSphere/QuadraSphere TACE|"HepaSphere/QuadraSphere TACE~HepaSphere/QuadraSphere Microspheres: HepaSphere/QuadraSphere Microspheres loaded with doxorubicin"
11065552|NCT01387932|BG001|Baseline|Conventional TACE|"Conventional TACE~PVA, lipiodol, doxorubicin: Conventional TACE procedure using PVA, lipiodol and doxorubicin"
11065553|NCT01387932|BG002|Baseline|Total|Total of all reporting groups
11065554|NCT01387932|FG000|Participant Flow|HepaSphere/QuadraSphere TACE|"HepaSphere/QuadraSphere TACE~Transarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing HepaSphere/QuadraSphere Microspheres loaded with doxorubicin."
11065555|NCT01387932|FG001|Participant Flow|Conventional TACE|"Conventional TACE~Transarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing PVA, lipiodol, doxorubicin."
11065556|NCT01387932|OG000|Outcome|HepaSphere/QuadraSphere TACE|"HepaSphere/QuadraSphere TACE~HepaSphere/QuadraSphere Microspheres: HepaSphere/QuadraSphere Microspheres loaded with doxorubicin"
11065557|NCT01387932|OG001|Outcome|Conventional TACE|"Conventional TACE~PVA, lipiodol, doxorubicin: Conventional TACE procedure using PVA, lipiodol and doxorubicin"
11065558|NCT01387932|OG000|Outcome|HepaSphere/QuadraSphere TACE|"HepaSphere/QuadraSphere TACE~Transarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing HepaSphere/QuadraSphere Microspheres loaded with doxorubicin."
11065559|NCT01387932|OG001|Outcome|Conventional TACE|"Conventional TACE~Transarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing PVA, lipiodol, doxorubicin."
11065560|NCT01387932|EG000|Reported Event|HepaSphere/QuadraSphere TACE|"HepaSphere/QuadraSphere TACE~Transarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing HepaSphere/QuadraSphere Microspheres loaded with doxorubicin."
11065561|NCT01387932|EG001|Reported Event|Conventional TACE|"Conventional TACE~Transarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing PVA, lipiodol, doxorubicin."
11065562|NCT01388166|BG000|Baseline|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
11065563|NCT01388166|FG000|Participant Flow|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
11065564|NCT01388166|OG000|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
11065565|NCT01388166|EG000|Reported Event|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) at least 1 months and within product label.
11065566|NCT01388335|BG000|Baseline|Warfarin + Enzastaurin|"Period 1 Day 1 (of an 8-day period): 5 milligram (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.~Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.~Safety Extension Period: Participants were allowed to continue receiving 500 mg enzastaurin orally once daily alone until disease progression or other discontinuation criteria were met.~Participants were on study for up to a total of 8 months (Period 1, Period 2 and Safety Extension Period)."
11065567|NCT01388335|FG000|Participant Flow|Warfarin + Enzastaurin|"Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.~Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.~Safety Extension Period: Participants were allowed to continue receiving 500 mg enzastaurin orally once daily alone until disease progression or other discontinuation criteria were met.~Participants were on study for up to a total of 8 months (Period 1, Period 2 and Safety Extension Period)."
11065568|NCT01388335|OG000|Outcome|Warfarin|Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
11065569|NCT01388335|OG001|Outcome|Warfarin + Enzastaurin|Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
11065570|NCT01388335|OG000|Outcome|Enzastaurin|Period 2 (19 up to 30 days): 500 milligrams (mg) enzastaurin administered orally once daily for at least 19 consecutive days. Participants were allowed to continue receiving enzastaurin for 30 days, then either entered the Safety Extension Phase and continued receiving enzastaurin (up to a total of 8 months following the first dose of study drug) until disease progression or discontinued.
11065571|NCT01388335|OG001|Outcome|Enzastaurin + Warfarin|Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
11065572|NCT01388335|OG000|Outcome|Warfarin|Period 1 Day 1 (of an 8 day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
11065573|NCT01388335|OG000|Outcome|Warfarin + Enzastaurin|Period 2 (19 up to 30 days): 500 milligrams (mg) enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
11065574|NCT01388335|EG000|Reported Event|Period 1|Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
11065575|NCT01388335|EG001|Reported Event|Period 2, Prior to Warfarin Dose|Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily up to Day 14.
11065576|NCT01388335|EG002|Reported Event|Period 2, Post Warfarin Dose|Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15. Enzastaurin administered up to 30 days total.
11065577|NCT01388335|EG003|Reported Event|Safety Extension|"Safety Extension: Participants were allowed to continue receiving 500 mg enzastaurin orally once daily alone until disease progression or other discontinuation criteria are met.~Participants were on study for up to a total 8 months (Period 1, Period 2 and Safety Extension)."
11066975|NCT01394614|FG000|Participant Flow|Narcoleptic Subjects Exposed to Vaccine|Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is after vaccine administration)
11065578|NCT01388361|BG000|Baseline|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
11065579|NCT01388361|BG001|Baseline|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
11065580|NCT01388361|BG002|Baseline|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
11065581|NCT01388361|BG003|Baseline|Total|Total of all reporting groups
11065582|NCT01388361|FG000|Participant Flow|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
11065583|NCT01388361|FG001|Participant Flow|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
11065584|NCT01388361|FG002|Participant Flow|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
11065585|NCT01388361|OG000|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
11065586|NCT01388361|OG001|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
11065587|NCT01388361|OG002|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
11065588|NCT01388361|EG000|Reported Event|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
11065589|NCT01388361|EG001|Reported Event|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
11065590|NCT01388361|EG002|Reported Event|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
11065591|NCT01388478|BG000|Baseline|R(+)Pramipexole|"Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.~R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects."
11066976|NCT01394614|FG001|Participant Flow|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (not vaccinated or vaccinated after the onset of symptoms)
11066977|NCT01394614|OG000|Outcome|Exposed Narcoleptic Subjects|"Exposed (vaccinated and onset of narcolepsy is post-vaccination) narcoleptic subjects~Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine Arepanrix."
11066978|NCT01394614|OG001|Outcome|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
11065592|NCT01388478|FG000|Participant Flow|R(+)Pramipexole|"Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.~R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects."
11065593|NCT01388478|OG000|Outcome|R(+)Pramipexole|"Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.~R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects."
11065594|NCT01388478|EG000|Reported Event|R(+)Pramipexole|"Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.~R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects."
11065595|NCT01388530|BG000|Baseline|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
11065596|NCT01388530|FG000|Participant Flow|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
11065597|NCT01388530|OG000|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
11065598|NCT01388530|EG000|Reported Event|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
11065599|NCT01388543|BG000|Baseline|CYP3A5 Expressors|"A pre-screening genetic test determines CYP3A5 expressor status~Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days"
11065600|NCT01388543|BG001|Baseline|CYP3A5 Non-expressors|"A pre-screening genetic test determines CYP3A5 non-expressor status~Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days"
11065601|NCT01388543|BG002|Baseline|Total|Total of all reporting groups
11065602|NCT01388543|FG000|Participant Flow|CYP3A5 Expressors|"A pre-screening genetic test determines CYP3A5 expressor status~Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days"
11065603|NCT01388543|FG001|Participant Flow|CYP3A5 Non-expressors|"A pre-screening genetic test determines CYP3A5 non-expressor status~Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days"
11065604|NCT01388543|OG000|Outcome|CYP3A5 Expressors|"A pre-screening genetic test determines CYP3A5 expressor status~Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days"
11065605|NCT01388543|OG001|Outcome|CYP3A5 Non-expressors|"A pre-screening genetic test determines CYP3A5 non-expressor status~Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days"
11065606|NCT01388543|EG000|Reported Event|CYP3A5 Expressor|"A pre-screening genetic test determines CYP3A5 expressor status~Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days"
11065607|NCT01388543|EG001|Reported Event|CYP3A5 Non-expressors|"A pre-screening genetic test determines CYP3A5 expressor status~Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days"
11065608|NCT01388647|BG000|Baseline|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
11065609|NCT01388647|BG001|Baseline|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
11065610|NCT01388647|BG002|Baseline|Total|Total of all reporting groups
11065611|NCT01388647|FG000|Participant Flow|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
11065612|NCT01388647|FG001|Participant Flow|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
11065613|NCT01388647|OG000|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
11065614|NCT01388647|OG001|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
11065615|NCT01388647|OG000|Outcome|All Study Participants|All subjects were assigned to receive either a starting dose of eribulin 1.1 mg/m^2 or eribulin 1.4 mg/m^2.
11065616|NCT01388647|EG000|Reported Event|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
11065617|NCT01388647|EG001|Reported Event|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
11065618|NCT01388777|BG000|Baseline|All Participants Enrolled and Started Treatment|All participants will undergo imaging, cryoablation and further imaging, then surgery.
11065619|NCT01388777|FG000|Participant Flow|All Participants Enrolled and Started Treatment|All participants will undergo imaging, cryoablation and further imaging, then surgery.
11065620|NCT01388777|OG000|Outcome|All Participants Enrolled and Started Treatment|All participants will undergo imaging, cryoablation and further imaging, then surgery.
11065621|NCT01388777|EG000|Reported Event|All Participants Enrolled and Started Treatment|All participants will undergo imaging, cryoablation and further imaging, then surgery.
11065622|NCT01388790|BG000|Baseline|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
11065623|NCT01388790|FG000|Participant Flow|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
11065624|NCT01388790|OG000|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
11065625|NCT01388790|EG000|Reported Event|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
11065626|NCT01388816|BG000|Baseline|Placebo Capsule|Once daily after breakfast
11065627|NCT01388816|BG001|Baseline|DRL-17822 50 mg|Once daily after breakfast
11065628|NCT01388816|BG002|Baseline|DRL-17822 150 mg|Once daily after breakfast
11065629|NCT01388816|BG003|Baseline|DRL-17822 300 mg|Once daily after breakfast
11065630|NCT01388816|BG004|Baseline|Total|Total of all reporting groups
11065631|NCT01388816|FG000|Participant Flow|Placebo|Once daily after breakfast
11065632|NCT01388816|FG001|Participant Flow|DRL-17822 50 mg|Once daily after breakfast
11065633|NCT01388816|FG002|Participant Flow|DRL-17822 150 mg|Once daily after breakfast
11065634|NCT01388816|FG003|Participant Flow|DRL-17822 300 mg|Once daily after breakfast
11065635|NCT01388816|OG000|Outcome|Placebo Capsule|Once daily after breakfast
11065636|NCT01388816|OG001|Outcome|DRL-17822 50 mg|Once daily after breakfast
11065637|NCT01388816|OG002|Outcome|DRL-17822 150 mg|Once daily after breakfast
11065638|NCT01388816|OG003|Outcome|DRL-17822 300 mg|Once daily after breakfast
11065639|NCT01388816|OG000|Outcome|DRL-17822 50 mg|Once daily after breakfast
11065640|NCT01388816|OG001|Outcome|DRL-17822 150 mg|Once daily after breakfast
11065641|NCT01388816|OG002|Outcome|DRL-17822 300 mg|Once daily after breakfast
11065642|NCT01388816|EG000|Reported Event|Placebo Capsule|Once daily after breakfast
11065643|NCT01388816|EG001|Reported Event|DRL-17822 50 mg|Once daily after breakfast
11065644|NCT01388816|EG002|Reported Event|DRL-17822 150 mg|Once daily after breakfast
11065645|NCT01388816|EG003|Reported Event|DRL-17822 300 mg|Once daily after breakfast
11066979|NCT01394614|EG000|Reported Event|Exposed Narcoleptic Subjects|"Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is post-vaccination)~Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine (Arepanrix)"
11066980|NCT01394614|EG001|Reported Event|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
11066981|NCT01394627|BG000|Baseline|All Participants|
11066982|NCT01394627|FG000|Participant Flow|Placebo (Period 1) /Washout (Period 2)/Eplerenone (Period 3)|"hypoglycemia of 50 mg/dl with 1 day of placebo pretreatment~then after 1-3 month washout~hypoglycemia of 50 mg/dl with 1 day of eplerenone (100 mg x 2) pretreatment"
11066983|NCT01394627|FG001|Participant Flow|Eplerenone (Period 1) /Washout (Period 2)/Placebo (Period 3)|"hypoglycemia of 50 mg/dl with 1 day of eplerenone (100 mg x 2) pretreatment~then after 1-3 month washout~hypoglycemia of 50 mg/dl with 1 day of placebo pretreatment"
11066984|NCT01394627|OG000|Outcome|Eplerenone|"hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose)~Eplerenone: 100mg x 2"
11066985|NCT01394627|OG001|Outcome|Placebo|"hypoglycemia of 50 mg/dl plus placebo~Placebo"
11066986|NCT01394627|EG000|Reported Event|Eplerenone|hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose) Eplerenone: 100mg x 2
11066987|NCT01394627|EG001|Reported Event|Placebo|hypoglycemia of 50 mg/dl plus placebo Placebo
11066988|NCT01394692|BG000|Baseline|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
11066989|NCT01394692|BG001|Baseline|Conventional Group|standard microsurgical tumor resection
11066990|NCT01394692|BG002|Baseline|Total|Total of all reporting groups
11066991|NCT01394692|FG000|Participant Flow|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
11066992|NCT01394692|FG001|Participant Flow|Conventional Group|standard microsurgical tumor resection
11066993|NCT01394692|OG000|Outcome|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
11065646|NCT01388907|BG000|Baseline|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
11065647|NCT01388907|BG001|Baseline|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
11065648|NCT01388907|BG002|Baseline|Total|Total of all reporting groups
11065649|NCT01388907|FG000|Participant Flow|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
11065650|NCT01388907|FG001|Participant Flow|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
11065651|NCT01388907|OG000|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
11065652|NCT01388907|OG001|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
11065653|NCT01388907|OG000|Outcome|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
11065654|NCT01388907|OG000|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
11065655|NCT01388907|EG000|Reported Event|Prevadh™ (P) Group With Adverse Event|Patients randomized in the Prevadh group have been treated with Prevadh Film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
11065656|NCT01388907|EG001|Reported Event|Ringer Lactate™ (R) Group With Adverse Event|"Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.~."
11065657|NCT01388946|BG000|Baseline|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
11065658|NCT01388946|BG001|Baseline|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
11065659|NCT01388946|BG002|Baseline|Total|Total of all reporting groups
11065660|NCT01388946|FG000|Participant Flow|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
11065661|NCT01388946|FG001|Participant Flow|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
11065662|NCT01388946|OG000|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
11065663|NCT01388946|OG001|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
11065664|NCT01388946|EG000|Reported Event|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
11065665|NCT01388946|EG001|Reported Event|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
11065666|NCT01388985|BG000|Baseline|Standard Vaccination Schedule|"One injection will be given on three different days (day 0, day 7 and day 21 or 28)~Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites"
11065667|NCT01388985|BG001|Baseline|Accelerated Vaccination Schedule|"Two injections will be given on the same day (day 0 and day 7): one on each forearm.~Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites"
11065668|NCT01388985|BG002|Baseline|Total|Total of all reporting groups
11065669|NCT01388985|FG000|Participant Flow|Standard Vaccination Schedule|"One injection will be given on three different days (day 0, day 7 and day 21 or 28)~Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites"
11065670|NCT01388985|FG001|Participant Flow|Accelerated Vaccination Schedule|"Two injections will be given on the same day (day 0 and day 7): one on each forearm.~Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites"
11065671|NCT01388985|OG000|Outcome|Standard Vaccination Schedule|"One injection will be given on three different days (day 0, day 7 and day 21 or 28)~Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites"
11065672|NCT01388985|OG001|Outcome|Accelerated Vaccination Schedule|"Two injections will be given on the same day (day 0 and day 7): one on each forearm.~Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites"
11065673|NCT01388985|EG000|Reported Event|Standard Vaccination Schedule|"One injection will be given on three different days (day 0, day 7 and day 21 or 28)~Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites"
11065674|NCT01388985|EG001|Reported Event|Accelerated Vaccination Schedule|"Two injections will be given on the same day (day 0 and day 7): one on each forearm.~Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites"
11065675|NCT01389076|BG000|Baseline|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
11066994|NCT01394692|OG001|Outcome|Conventional Group|standard microsurgical tumor resection
11066995|NCT01394692|EG000|Reported Event|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
11065676|NCT01389076|FG000|Participant Flow|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
11065677|NCT01389076|OG000|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
11065678|NCT01389076|EG000|Reported Event|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
11065679|NCT01389102|BG000|Baseline|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065680|NCT01389102|BG001|Baseline|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065681|NCT01389102|BG002|Baseline|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
11065682|NCT01389102|BG003|Baseline|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065683|NCT01389102|BG004|Baseline|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065684|NCT01389102|BG005|Baseline|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
11065685|NCT01389102|BG006|Baseline|Total|Total of all reporting groups
11065686|NCT01389102|FG000|Participant Flow|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065687|NCT01389102|FG001|Participant Flow|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065688|NCT01389102|FG002|Participant Flow|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
11065689|NCT01389102|FG003|Participant Flow|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065690|NCT01389102|FG004|Participant Flow|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065691|NCT01389102|FG005|Participant Flow|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
11065692|NCT01389102|OG000|Outcome|Placebo Transdermal Three 90 μL Sprays|
11065693|NCT01389102|OG001|Outcome|Placebo Transdermal Two 90 μL Sprays|
11065694|NCT01389102|OG002|Outcome|Placebo Transdermal One 90 μL Spray|
11065695|NCT01389102|OG003|Outcome|Estradiol Transdermal Three 90 μL Sprays|
11065696|NCT01389102|OG004|Outcome|Estradiol Transdermal Two 90 μL Sprays|
11065697|NCT01389102|OG005|Outcome|Estradiol Transdermal One 90 μL Spray|
11065698|NCT01389102|OG000|Outcome|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065699|NCT01389102|OG001|Outcome|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065700|NCT01389102|OG002|Outcome|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
11065701|NCT01389102|OG003|Outcome|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065702|NCT01389102|OG004|Outcome|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065703|NCT01389102|OG005|Outcome|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
11065704|NCT01389102|EG000|Reported Event|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065705|NCT01389102|EG001|Reported Event|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065706|NCT01389102|EG002|Reported Event|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
11065707|NCT01389102|EG003|Reported Event|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065708|NCT01389102|EG004|Reported Event|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
11065709|NCT01389102|EG005|Reported Event|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
11065710|NCT01389128|BG000|Baseline|Control Group|"Control Group (CG): Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.~Control Group: Routine care of the institution performed by the staff, without the presence of the researcher"
11065711|NCT01389128|BG001|Baseline|Intervention Group|"Intervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (>or= 7 cm);~Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower;"
11065712|NCT01389128|BG002|Baseline|Total|Total of all reporting groups
11065713|NCT01389128|FG000|Participant Flow|Control Group|"Control Group (CG): Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.~Control Group: Routine care of the institution performed by the staff, without the presence of the researcher"
11065714|NCT01389128|FG001|Participant Flow|Intervention Group|"Intervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (>or= 7 cm);~Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower;"
11065715|NCT01389128|OG000|Outcome|Control Group|"Control Group (CG): Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.~Control Group: Routine care of the institution performed by the staff, without the presence of the researcher"
11065716|NCT01389128|OG001|Outcome|Intervention Group|"Intervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (>or= 7 cm);~Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower;"
11065717|NCT01389128|OG000|Outcome|Control Group|Routine care of the institution
11065718|NCT01389128|OG001|Outcome|Intervention Group|Combined and sequential non-pharmacological resources
11065719|NCT01389128|OG000|Outcome|Control Group|Control Group: Routine care of the institution performed by the staff, without the presence of the researcher
11065720|NCT01389128|OG001|Outcome|Intervention Group|Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower;
11065721|NCT01389128|EG000|Reported Event|Control Group|"Control Group (CG): Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.~Control Group: Routine care of the institution performed by the staff, without the presence of the researcher"
11065722|NCT01389128|EG001|Reported Event|Intervention Group|"Intervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (>or= 7 cm);~Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower;"
11065723|NCT01389232|BG000|Baseline|SeriScaffold® Surgical Scaffold|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065724|NCT01389232|FG000|Participant Flow|SeriScaffold® Surgical Scaffold|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065725|NCT01389232|OG000|Outcome|SeriScaffold® Surgical Scaffold|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065726|NCT01389232|OG000|Outcome|Ease of Use During Surgery = Very Difficult to Use|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065727|NCT01389232|OG001|Outcome|Ease of Use During Surgery = Difficult to Use|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065728|NCT01389232|OG002|Outcome|Ease of Use During Surgery = Neither Difficult Nor Easy to Use|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065729|NCT01389232|OG003|Outcome|Ease of Use During Surgery = Easy to Use|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065730|NCT01389232|OG004|Outcome|Ease of Use During Surgery = Very Easy to Use|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065731|NCT01389232|OG005|Outcome|Not Done|"Implanted participants on whom procedure was reported not done"
11065732|NCT01389232|OG000|Outcome|Sternal Notch to Apex|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065733|NCT01389232|OG001|Outcome|Sternal Notch to Inframammary Fold|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065734|NCT01389232|OG002|Outcome|Apex to Inframammary Fold|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065735|NCT01389232|OG003|Outcome|Medial Mammary Fold to Lateral Mammary Fold|Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065736|NCT01389232|EG000|Reported Event|SeriScaffold® Surgical Scaffold|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
11065737|NCT01389245|BG000|Baseline|OsseoSpeed™ TX|OsseoSpeed™ TX implants of lengths 8-17 mm
11065738|NCT01389245|FG000|Participant Flow|OsseoSpeed™ TX|OsseoSpeed™ TX implants of lengths 8-17 mm
11065739|NCT01389245|OG000|Outcome|OsseoSpeed™ TX|OsseoSpeed™ TX implants of lengths 8-17 mm
11065740|NCT01389245|EG000|Reported Event|OsseoSpeed™ TX|OsseoSpeed™ TX implants of lengths 8-17 mm
11065741|NCT01389258|BG000|Baseline|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
11065742|NCT01389258|FG000|Participant Flow|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
11065743|NCT01389258|OG000|Outcome|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
11065744|NCT01389258|EG000|Reported Event|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
11065745|NCT01389284|BG000|Baseline|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
11065746|NCT01389284|BG001|Baseline|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
11065747|NCT01389284|BG002|Baseline|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
11065748|NCT01389284|BG003|Baseline|Total|Total of all reporting groups
11065749|NCT01389284|FG000|Participant Flow|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
11065750|NCT01389284|FG001|Participant Flow|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
11065751|NCT01389284|FG002|Participant Flow|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
11065752|NCT01389284|OG000|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
11065753|NCT01389284|OG001|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
11065754|NCT01389284|OG002|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
11065755|NCT01389284|EG000|Reported Event|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
11065756|NCT01389284|EG001|Reported Event|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
11065757|NCT01389284|EG002|Reported Event|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
11065758|NCT01389323|BG000|Baseline|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
11065759|NCT01389323|FG000|Participant Flow|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
11066996|NCT01394692|EG001|Reported Event|Conventional Group|standard microsurgical tumor resection
11066997|NCT01394705|BG000|Baseline|Standard of Care|BodyMedia: Accelerometer
11066998|NCT01394705|BG001|Baseline|Intervention|BodyMedia: Accelerometer
11066999|NCT01394705|BG002|Baseline|Total|Total of all reporting groups
11065760|NCT01389323|OG000|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
11065761|NCT01389323|OG001|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
11065762|NCT01389323|OG002|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
11065763|NCT01389323|OG000|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
11065764|NCT01389323|OG001|Outcome|White/Caucasian Cohort|Participants belonging to White/Caucasian race, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
11065765|NCT01389323|OG002|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
11065766|NCT01389323|OG003|Outcome|Non-Latino Cohort|Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
11065767|NCT01389323|OG004|Outcome|Overall Population|Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
11067000|NCT01394705|FG000|Participant Flow|Standard of Care|BodyMedia: Accelerometer
11067001|NCT01394705|FG001|Participant Flow|Intervention|BodyMedia: Accelerometer
11067002|NCT01394705|OG000|Outcome|Standard of Care|office provider exercise counseling
11065768|NCT01389323|EG000|Reported Event|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
11065769|NCT01389596|BG000|Baseline|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
11065770|NCT01389596|BG001|Baseline|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
11065771|NCT01389596|BG002|Baseline|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
11065772|NCT01389596|BG003|Baseline|Total|Total of all reporting groups
11065773|NCT01389596|FG000|Participant Flow|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and less than (<) 30 kilograms (kg) in weight, received pregabalin 3.5 milligram per kilogram per day (mg/kg/day) (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and greater than or equal to (>=) 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
11065774|NCT01389596|FG001|Participant Flow|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
11065775|NCT01389596|FG002|Participant Flow|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
11065776|NCT01389596|OG000|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
11065777|NCT01389596|OG001|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
11065778|NCT01389596|OG002|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
11065779|NCT01389596|EG000|Reported Event|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
11065780|NCT01389596|EG001|Reported Event|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
11065781|NCT01389596|EG002|Reported Event|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
11067003|NCT01394705|OG001|Outcome|Intervention|BodyMedia: Accelerometer wear
11067004|NCT01394705|OG001|Outcome|Intervention|BodyMedia: Accelerometer
11065782|NCT01389752|BG000|Baseline|Overall|During Study Period 1, participants received a single oral dose of 18 mg LY2216684 alone or in combination with 1 g/kg Activated Charcoal 1 hour after LY2216684 administration. After at least 7 days, participants who initially received 18 mg LY2216684 alone received another single oral dose of 18 mg LY2216684 in combination with 1 g/kg Activated Charcoal 1 hour after LY2216684 administration during Study Period 2; participants who initially received 18 mg LY2216684 in combination with 1 g/kg Activated Charcoal received another single oral dose of 18 mg LY2216684 alone during Study Period 2.
11065783|NCT01389752|FG000|Participant Flow|LY2216684 Without Charcoal, Then With Charcoal|Period 1: Single 18-mg (milligram) (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal. Periods will be separated by a minimum of 7 days.
11065784|NCT01389752|FG001|Participant Flow|LY2216684 With Charcoal, Then Without Charcoal|Period 1: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg of Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Periods will be separated by a minimum of 7 days.
11065785|NCT01389752|OG000|Outcome|LY2216684 in Combination With Activated Charcoal|Participants received a single oral dose of 18 mg (milligram) LY2216684 and a single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal 1 hour after administration of LY2216684.
11065786|NCT01389752|OG001|Outcome|LY2216684 Alone|Participants received a single oral dose of 18 mg LY2216684.
11065787|NCT01389752|OG000|Outcome|LY2216684 in Combination With Activated Charcoal|Participants received a single oral dose of 18 mg LY2216684 and a single oral dose of 1 g/kg of Activated Charcoal 1 hour after administration of LY2216684.
11065788|NCT01389752|EG000|Reported Event|LY2216684 in Combination With Activated Charcoal|Participants received a single oral dose of 18 mg (milligram) LY2216684 and a single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal 1 hour after administration of LY2216684.
11065789|NCT01389752|EG001|Reported Event|LY2216684 Alone|Participants received a single oral dose of 18 mg LY2216684.
11065790|NCT01389765|BG000|Baseline|Overall|In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in either fasted or fed state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the alternative feeding state that was not used during Period 1 (fasted or fed). Periods were separated by a 7-day washout period.
11065791|NCT01389765|FG000|Participant Flow|LY2216684 During Fed, Then LY2216684 During Fasting State|In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in fed state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the fasting state. Periods were separated by a 7-day washout period.
11065792|NCT01389765|FG001|Participant Flow|LY2216684 During Fasting, Then LY2216684 During Fed State|In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in fasting state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the fed state. Periods were separated by a 7-day washout period.
11065793|NCT01389765|OG000|Outcome|LY2216684 Administered in Fed State|Participants received a single oral dose of 18 mg LY2216684 in fed state.
11065794|NCT01389765|OG001|Outcome|LY2216684 Administered in Fasted State|Participants received a single oral dose of 18 mg LY2216684 in fasted state.
11065795|NCT01389765|EG000|Reported Event|LY2216684 Administered in Fed State|Participants received a single oral dose of 18 mg LY2216684 in fed state.
11065796|NCT01389765|EG001|Reported Event|LY2216684 Administered in Fasted State|Participants received a single oral dose of 18 mg LY2216684 in fasted state.
11065797|NCT01389856|BG000|Baseline|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
11065798|NCT01389856|BG001|Baseline|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
11065799|NCT01389856|BG002|Baseline|Total|Total of all reporting groups
11065800|NCT01389856|FG000|Participant Flow|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
11065801|NCT01389856|FG001|Participant Flow|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
11065802|NCT01389856|OG000|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
11065803|NCT01389856|OG001|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
11065804|NCT01389856|EG000|Reported Event|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
11065805|NCT01389856|EG001|Reported Event|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
11065806|NCT01389882|BG000|Baseline|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
11065807|NCT01389882|BG001|Baseline|NS Group|NAVA first, then SIMV with PS
11065808|NCT01389882|BG002|Baseline|Total|Total of all reporting groups
11065809|NCT01389882|FG000|Participant Flow|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
11065810|NCT01389882|FG001|Participant Flow|NS Group|NAVA first, then SIMV with PS
11065811|NCT01389882|OG000|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
11065812|NCT01389882|OG001|Outcome|NAVA|neurally adjusted ventilatory assist
11067005|NCT01394705|EG000|Reported Event|Standard of Care|BodyMedia: Accelerometer
11065813|NCT01389882|EG000|Reported Event|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
11065814|NCT01389882|EG001|Reported Event|NS Group|NAVA first, then SIMV with PS
11065815|NCT01389973|BG000|Baseline|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
11065816|NCT01389973|FG000|Participant Flow|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
11065817|NCT01389973|OG000|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
11065818|NCT01389973|EG000|Reported Event|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
11065819|NCT01390038|BG000|Baseline|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
11065820|NCT01390038|FG000|Participant Flow|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
11065821|NCT01390038|OG000|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
11065822|NCT01390038|EG000|Reported Event|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
11065823|NCT01390064|BG000|Baseline|Initial Cohort|"Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms~Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
11065824|NCT01390064|BG001|Baseline|Escalation Cohort|"Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms~Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
11065825|NCT01390064|BG002|Baseline|Total|Total of all reporting groups
11065826|NCT01390064|FG000|Participant Flow|Initial Cohort|"Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms~Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
11065827|NCT01390064|FG001|Participant Flow|Escalation Cohort|"Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms~Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
11065828|NCT01390064|OG000|Outcome|Initial Cohort|"Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms~Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
11065829|NCT01390064|OG001|Outcome|Escalation Cohort|"Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms~Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
11065830|NCT01390064|EG000|Reported Event|Initial Cohort|"Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms~Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
11065831|NCT01390064|EG001|Reported Event|Escalation Cohort|"Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms~Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule"
11065832|NCT01390077|BG000|Baseline|Nitisinone|"all subjects will receive open-label nitisinone~Nitisinone: Taken orally. Supplied as a 2mg tablet. The starting dose is 2 mg once daily."
11065833|NCT01390077|FG000|Participant Flow|Nitisinone|All subjects received open-label nitisinone, taken orally, supplied as a 2mg tablet. The starting dose was 2 mg once daily, and increased to 4, 6, or 8 mg, case-by-case.
11065834|NCT01390077|OG000|Outcome|HGA, Baseline|Urine homogentisic acid (umol/mmol Cr), while taking no nitisinone
11065835|NCT01390077|OG001|Outcome|HGA, 2 mg/d Nitisinone|Urine homogentisic acid (umol/mmol Cr), while on nitisinone, 2 mg/d
11065836|NCT01390077|OG002|Outcome|HGA, 4 mg Nitisinone|Urine homogentisic acid (umol/mmol Cr), while on 4 mg/d nitisinone
11065837|NCT01390077|OG000|Outcome|Tyrosine, Baseline|Plasma tyrosine (uM), while taking no nitisinone
11065838|NCT01390077|OG001|Outcome|Tyrosine, 2 mg/d Nitisinone|Plasma tyrosine (uM), while on nitisinone, 2 mg/d
11065839|NCT01390077|OG002|Outcome|Tyrosine, 4 mg Nitisinone|Plasma tyrosine (uM), while on 4 mg/d nitisinone
11065840|NCT01390077|EG000|Reported Event|Nitisinone|"All subjects who participated in treatment received open-label nitisinone, taken orally, supplied as a 2mg tablet.~The starting dose was 2 mg once daily, and increased to 4, 6, and 8 mg/d, case-by-case."
11065841|NCT01390220|BG000|Baseline|USL261 Test Dose|Participants who received at least 1 open-label USL261 5 mg dose in Test Dose Phase (TDP)
11067006|NCT01394705|EG001|Reported Event|Intervention|BodyMedia: Accelerometer
11065842|NCT01390220|FG000|Participant Flow|USL261 TDP|Participants who received at least 1 open-label USL261 5 mg dose in Test Dose Phase (TDP)
11065843|NCT01390220|FG001|Participant Flow|USL261 CP|Participants completing TDP who received USL261 5 mg as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP)
11065844|NCT01390220|FG002|Participant Flow|Placebo CP|Participants completing TDP who received placebo as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP)
11065845|NCT01390220|OG000|Outcome|USL261 CP|"5 mg intranasal midazolam~USL261"
11065846|NCT01390220|OG001|Outcome|Placebo CP|"Intranasal placebo~Placebo"
11065847|NCT01390220|EG000|Reported Event|USL261 TDP|Participants who received at least 1 open-label USL261 5 mg dose in Test Dose Phase (TDP)
11065848|NCT01390220|EG001|Reported Event|USL261 CP, USL261 5 mg Only|Participants completing TDP who received USL261 5 mg as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP)
11065849|NCT01390220|EG002|Reported Event|USL261 CP, USL261 5 mg + 5 mg|Participants completing TDP who received USL261 5 mg as randomized dose to treat a seizure cluster episode and received an open-label USL261 5 mg dose in the Comparative Phase (CP)
11065850|NCT01390220|EG003|Reported Event|Placebo CP, Placebo Only|Participants completing TDP who received Placebo as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP)
11065851|NCT01390220|EG004|Reported Event|Placebo CP, Placebo + USL261 5 mg|Participants completing TDP who received Placebo as randomized dose to treat a seizure cluster episode and received an open-label USL261 5 mg dose in the Comparative Phase (CP)
11065852|NCT01390233|BG000|Baseline|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
11065853|NCT01390233|BG001|Baseline|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
11065854|NCT01390233|BG002|Baseline|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
11065855|NCT01390233|BG003|Baseline|Total|Total of all reporting groups
11065856|NCT01390233|FG000|Participant Flow|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
11065857|NCT01390233|FG001|Participant Flow|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
11065858|NCT01390233|FG002|Participant Flow|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
11065859|NCT01390233|OG000|Outcome|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
11065860|NCT01390233|OG001|Outcome|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
11065861|NCT01390233|OG002|Outcome|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
11065862|NCT01390233|EG000|Reported Event|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
11065863|NCT01390233|EG001|Reported Event|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
11065864|NCT01390233|EG002|Reported Event|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
11065865|NCT01390246|BG000|Baseline|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
11065866|NCT01390246|BG001|Baseline|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
11065867|NCT01390246|BG002|Baseline|Total|Total of all reporting groups
11065868|NCT01390246|FG000|Participant Flow|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
11065869|NCT01390246|FG001|Participant Flow|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
11065870|NCT01390246|OG000|Outcome|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
11065871|NCT01390246|OG001|Outcome|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
11065872|NCT01390246|EG000|Reported Event|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
11065873|NCT01390246|EG001|Reported Event|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
11065874|NCT01390259|BG000|Baseline|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.~Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
11065875|NCT01390259|FG000|Participant Flow|Open-Loop First, Then Closed-Loop|"Open-Loop first, then Closed-Loop control (CLC)~Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
11065876|NCT01390259|FG001|Participant Flow|Closed-Loop Control First, Then Open-Loop|"Closed-Loop control (CLC) first, then Open-Loop~Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
11065877|NCT01390259|OG000|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
11065878|NCT01390259|OG001|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
11065879|NCT01390259|EG000|Reported Event|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.~Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
11065880|NCT01390272|BG000|Baseline|Titration Intervention|"The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement].~Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring.~High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management.~Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control.~Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months."
11065881|NCT01390272|BG001|Baseline|LPN Control|"A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.~Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months."
11065882|NCT01390272|BG002|Baseline|Total|Total of all reporting groups
11065883|NCT01390272|FG000|Participant Flow|Titration Intervention|"The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement].~Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring.~High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management.~Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control.~Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months."
11065884|NCT01390272|FG001|Participant Flow|LPN Control|"A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.~Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months."
11065885|NCT01390272|OG000|Outcome|Titration Intervention|"The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement].~Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring.~High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management.~Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control.~Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months."
11065886|NCT01390272|OG001|Outcome|LPN Control|"A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.~Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months."
11065887|NCT01390272|EG000|Reported Event|Titration Intervention|"The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement].~Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring.~High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management.~Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control.~Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months."
11065888|NCT01390272|EG001|Reported Event|LPN Control|"A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.~Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months."
11065889|NCT01390298|BG000|Baseline|All Study Participants|"Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacement will be consented to participate~Observational: Observational study only"
11065890|NCT01390298|FG000|Participant Flow|All Study Participants|"Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacment~Observational: Observational study only"
11065891|NCT01390298|OG000|Outcome|All Study Participants|"Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacment~Observational: Observational study only"
11065892|NCT01390298|EG000|Reported Event|Observational|"Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacment~Observational: Observational study only"
11065893|NCT01390389|BG000|Baseline|Control|Healthy controls with no evidence of current or past psychiatric disorders.
11065894|NCT01390389|BG001|Baseline|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
11065895|NCT01390389|BG002|Baseline|Total|Total of all reporting groups
11065896|NCT01390389|FG000|Participant Flow|Control|Healthy controls with no evidence of current or past psychiatric disorders.
11065897|NCT01390389|FG001|Participant Flow|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
11065898|NCT01390389|OG000|Outcome|Control|Healthy controls with no evidence of current or past psychiatric disorders.
11065899|NCT01390389|OG001|Outcome|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
11065900|NCT01390389|OG000|Outcome|Control Baseline (Week 0)|Healthy controls with no evidence of current or past psychiatric disorders.
11065901|NCT01390389|OG001|Outcome|Control Week 4|Healthy controls with no evidence of current or past psychiatric disorders. Subjects did not receive study drug.
11065902|NCT01390389|OG002|Outcome|CoQ10 Baseline (Week 0)|Subjects with Bipolar disorder who had not yet received study drug.
11065903|NCT01390389|OG003|Outcome|CoQ10 Week 4|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
11065904|NCT01390389|EG000|Reported Event|Control|Healthy controls with no evidence of current or past psychiatric disorders.
11065905|NCT01390389|EG001|Reported Event|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
11065906|NCT01390402|BG000|Baseline|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
11065907|NCT01390402|FG000|Participant Flow|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
11065908|NCT01390402|OG000|Outcome|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
11065909|NCT01390402|EG000|Reported Event|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
11065910|NCT01390428|BG000|Baseline|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
11065911|NCT01390428|BG001|Baseline|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
11065912|NCT01390428|BG002|Baseline|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
11065913|NCT01390428|BG003|Baseline|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
11065914|NCT01390428|BG004|Baseline|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
11065915|NCT01390428|BG005|Baseline|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
11065916|NCT01390428|BG006|Baseline|Total|Total of all reporting groups
11065917|NCT01390428|FG000|Participant Flow|Part 1-Mild Hepatic Impairment (HI)|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
11065918|NCT01390428|FG001|Participant Flow|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
11065919|NCT01390428|FG002|Participant Flow|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
11065920|NCT01390428|FG003|Participant Flow|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
11065921|NCT01390428|FG004|Participant Flow|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
11065922|NCT01390428|FG005|Participant Flow|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
11065923|NCT01390428|OG000|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
11065924|NCT01390428|OG001|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
11065925|NCT01390428|OG002|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
11065926|NCT01390428|OG003|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
11065927|NCT01390428|OG004|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
11065928|NCT01390428|OG005|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
11065929|NCT01390428|EG000|Reported Event|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
11065930|NCT01390428|EG001|Reported Event|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
11065931|NCT01390428|EG002|Reported Event|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
11065932|NCT01390428|EG003|Reported Event|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
11065933|NCT01390428|EG004|Reported Event|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
11065934|NCT01390428|EG005|Reported Event|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
11065935|NCT01390441|BG000|Baseline|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065936|NCT01390441|BG001|Baseline|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065937|NCT01390441|BG002|Baseline|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065938|NCT01390441|BG003|Baseline|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065939|NCT01390441|BG004|Baseline|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065940|NCT01390441|BG005|Baseline|Total|Total of all reporting groups
11065941|NCT01390441|FG000|Participant Flow|Part A: MK-8808 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial.
11065942|NCT01390441|FG001|Participant Flow|Part A: MabThera® 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065943|NCT01390441|FG002|Participant Flow|Part B: MK-8808 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065944|NCT01390441|FG003|Participant Flow|Part B: MabThera® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065945|NCT01390441|FG004|Participant Flow|Part B: Rituxan® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065946|NCT01390441|OG000|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065947|NCT01390441|OG001|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065948|NCT01390441|OG000|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065949|NCT01390441|OG001|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065950|NCT01390441|OG002|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065951|NCT01390441|OG001|Outcome|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065952|NCT01390441|OG002|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065953|NCT01390441|OG003|Outcome|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065954|NCT01390441|OG004|Outcome|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065955|NCT01390441|OG005|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065956|NCT01390441|OG006|Outcome|Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065957|NCT01390441|OG007|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065958|NCT01390441|OG008|Outcome|Extension B: MabThera 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065959|NCT01390441|OG009|Outcome|Extension B: Rituxan1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065960|NCT01390441|OG003|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065961|NCT01390441|OG004|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065962|NCT01390441|OG006|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065963|NCT01390441|OG008|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065964|NCT01390441|OG009|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065965|NCT01390441|OG000|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously SC, or IM for the duration of the trial.
11065966|NCT01390441|OG000|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or IM for the duration of the trial.
11065967|NCT01390441|OG000|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065968|NCT01390441|OG001|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065969|NCT01390441|OG002|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065970|NCT01390441|OG003|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065971|NCT01390441|OG004|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065972|NCT01390441|EG000|Reported Event|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065973|NCT01390441|EG001|Reported Event|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065974|NCT01390441|EG002|Reported Event|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065975|NCT01390441|EG003|Reported Event|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065976|NCT01390441|EG004|Reported Event|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065977|NCT01390441|EG005|Reported Event|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065978|NCT01390441|EG006|Reported Event|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065979|NCT01390441|EG007|Reported Event|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065980|NCT01390441|EG008|Reported Event|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065981|NCT01390441|EG009|Reported Event|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
11065982|NCT01390584|BG000|Baseline|Arm A (ABVD + INRT)|"Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.~PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.~ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks."
11065983|NCT01390584|BG001|Baseline|Arm B (ABVD + BEACOPP + INRT)|"Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.~PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.~BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks."
11065984|NCT01390584|BG002|Baseline|Total|Total of all reporting groups
11065985|NCT01390584|FG000|Participant Flow|ABVD + INRT|"Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.~PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.~ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks."
11065986|NCT01390584|FG001|Participant Flow|ABVD + BEACOPP + INRT|"Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.~PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.~BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks."
11065987|NCT01390584|FG002|Participant Flow|Induction ABVD|Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
11067086|NCT01395277|FG000|Participant Flow|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.~During the first visit the high flavanol measures will be performed before and 2 hours following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
10914681|NCT00632463|BG003|Baseline|Total|Total of all reporting groups
10914682|NCT00632463|FG000|Participant Flow|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
11067087|NCT01395277|FG001|Participant Flow|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.~During the first visit the low flavanol measures will be performed before and 2 hours following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
11067088|NCT01395277|OG000|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).~CocoaVia Dark Chocolate Flavored Drink: The experimental trial (high flavanol group) will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
11067089|NCT01395277|OG001|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).~Placebo Trial: CocoaVia Dark Chocolate Flavored Drink: The placebo trial (low flavanol content) will be performed following consumption of a beverage containing 75 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
11067090|NCT01395277|OG000|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.~The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
11067091|NCT01395277|OG001|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.~The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The hihg flavanol measures will be performed following consumption of a beverage containing 1,0500 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
11067092|NCT01395277|EG000|Reported Event|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.~The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
11067093|NCT01395277|EG001|Reported Event|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.~The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
11067094|NCT01395316|BG000|Baseline|Alemtuzumab|"Single arm, single cohort study, all subjects will be dosed with alemtuzumab.~Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days."
11067095|NCT01395316|FG000|Participant Flow|Alemtuzumab|"Single arm, single cohort study, all subjects will be dosed with alemtuzumab.~Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days."
10887441|NCT00500357|EG000|Reported Event|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)|"Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).~For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46."
10887442|NCT00500357|EG001|Reported Event|13vPnC+AlPO4 (After Vax 1 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
10887443|NCT00500357|EG002|Reported Event|13vPnC-AlPO4 (After Vax 1 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
10887444|NCT00500357|EG003|Reported Event|23vPS (After Vax 1 Core Study)|Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
10887445|NCT00500357|EG004|Reported Event|13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)|Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
10887446|NCT00500357|EG005|Reported Event|13vPnC+AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
10887447|NCT00500357|EG006|Reported Event|13vPnC-AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
10887448|NCT00500370|BG000|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
10887449|NCT00500370|BG001|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
10887450|NCT00500370|BG002|Baseline|Total|Total of all reporting groups
10887451|NCT00500370|FG000|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
10887452|NCT00500370|FG001|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
10887453|NCT00500370|OG000|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
11067096|NCT01395316|OG000|Outcome|Alemtuzumab|"Single arm, single cohort study, all subjects will be dosed with alemtuzumab.~Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days."
10887454|NCT00500370|OG001|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
10887455|NCT00500370|EG000|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
10887456|NCT00500370|EG001|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
10887457|NCT00500448|BG000|Baseline|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
10887458|NCT00500448|BG001|Baseline|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
10887459|NCT00500448|BG002|Baseline|Total|Total of all reporting groups
10887460|NCT00500448|FG000|Participant Flow|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
10887461|NCT00500448|FG001|Participant Flow|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
10887462|NCT00500448|OG000|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
10887463|NCT00500448|OG001|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
10887464|NCT00500448|EG000|Reported Event|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
10887465|NCT00500448|EG001|Reported Event|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
10887466|NCT00500539|BG000|Baseline|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
10887467|NCT00500539|FG000|Participant Flow|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
10887468|NCT00500539|OG000|Outcome|Follow-up Period|Participants were evaluated at 16 weeks after the last dose of study drug.
10887469|NCT00500539|OG000|Outcome|Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
10887470|NCT00500539|OG000|Outcome|Follow-up Period|Participants were assessed at 16 weeks after the last dose of study drug
10887471|NCT00500539|EG000|Reported Event|Omalizumab Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
11067097|NCT01395316|EG000|Reported Event|Alemtuzumab|"Single arm, single cohort study, all subjects will be dosed with alemtuzumab.~Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days."
11067098|NCT01395329|BG000|Baseline|Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11067099|NCT01395329|BG001|Baseline|Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11067100|NCT01395329|BG002|Baseline|Placebo|Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
11067101|NCT01395329|BG003|Baseline|Total|Total of all reporting groups
11067102|NCT01395329|FG000|Participant Flow|Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11067103|NCT01395329|FG001|Participant Flow|Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11067104|NCT01395329|FG002|Participant Flow|Placebo|Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
11067105|NCT01395329|OG000|Outcome|Before Nebivolol|Before randomization to Nebivolol
11067106|NCT01395329|OG001|Outcome|After Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11067107|NCT01395329|OG002|Outcome|Before Metoprolol|Before randomization to Metoprolol
11067108|NCT01395329|OG003|Outcome|After Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11067109|NCT01395329|OG004|Outcome|Before Placebo|Before randomization to placebo
11067110|NCT01395329|OG005|Outcome|After Placebo|Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
11067111|NCT01395329|EG000|Reported Event|Nebivolol|Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
11067112|NCT01395329|EG001|Reported Event|Metoprolol|Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
11067113|NCT01395329|EG002|Reported Event|Placebo|Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
11067114|NCT01395368|BG000|Baseline|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
11067115|NCT01395368|FG000|Participant Flow|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
11067116|NCT01395368|OG000|Outcome|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
11067117|NCT01395368|EG000|Reported Event|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
11067118|NCT01395394|BG000|Baseline|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067119|NCT01395394|BG001|Baseline|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067120|NCT01395394|BG002|Baseline|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067121|NCT01395394|BG003|Baseline|Total|Total of all reporting groups
11067122|NCT01395394|FG000|Participant Flow|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
10887472|NCT00500539|EG001|Reported Event|Omalizumab Follow up Period|Participants were assessed at 16 weeks after the last dose of study drug
11067123|NCT01395394|FG001|Participant Flow|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067124|NCT01395394|FG002|Participant Flow|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11173487|NCT02015819|BG001|Baseline|Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11173488|NCT02015819|BG002|Baseline|Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11067125|NCT01395394|OG000|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067126|NCT01395394|OG001|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067127|NCT01395394|OG002|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067128|NCT01395394|EG000|Reported Event|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067129|NCT01395394|EG001|Reported Event|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067130|NCT01395394|EG002|Reported Event|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
11067131|NCT01395524|BG000|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
11067132|NCT01395524|BG001|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11067133|NCT01395524|BG002|Baseline|Placebo|Placebo QD, oral treatment
10887473|NCT00500578|BG000|Baseline|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
11067134|NCT01395524|BG003|Baseline|Total|Total of all reporting groups
11067135|NCT01395524|FG000|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
11067136|NCT01395524|FG001|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11067137|NCT01395524|FG002|Participant Flow|Placebo|Placebo QD, oral treatment
11067138|NCT01395524|OG000|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
11067139|NCT01395524|OG001|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
11067140|NCT01395524|OG002|Outcome|Placebo|Placebo QD, oral treatment
11067141|NCT01395524|EG000|Reported Event|NKTR-118 12.5 mg|
11067142|NCT01395524|EG001|Reported Event|NKTR-118 25 mg|
11067143|NCT01395524|EG002|Reported Event|Placebo|
11067144|NCT01395537|BG000|Baseline|Lapatinib With Carboplatin and Paclitaxel|"Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.~Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.~lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals."
11067145|NCT01395537|FG000|Participant Flow|Lapatinib With Carboplatin and Paclitaxel|"Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.~Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.~lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals."
11067146|NCT01395537|OG000|Outcome|Lapatinib With Carboplatin and Paclitaxel|"Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.~Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.~lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals."
11067147|NCT01395537|EG000|Reported Event|Lapatinib With Carboplatin and Paclitaxel|"Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.~Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.~lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals."
11067148|NCT01395758|BG000|Baseline|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
10887474|NCT00500578|BG001|Baseline|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
10887475|NCT00500578|BG002|Baseline|Total|Total of all reporting groups
10887476|NCT00500578|FG000|Participant Flow|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
10887477|NCT00500578|FG001|Participant Flow|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
10887478|NCT00500578|OG000|Outcome|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
10887479|NCT00500578|OG001|Outcome|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
10887480|NCT00500578|EG000|Reported Event|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
10887481|NCT00500578|EG001|Reported Event|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
10887482|NCT00500656|BG000|Baseline|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
10887483|NCT00500656|BG001|Baseline|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
10887484|NCT00500656|BG002|Baseline|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
10887485|NCT00500656|BG003|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
10887486|NCT00500656|BG004|Baseline|Total|Total of all reporting groups
10887487|NCT00500656|FG000|Participant Flow|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
10887488|NCT00500656|FG001|Participant Flow|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
10887489|NCT00500656|FG002|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
10887490|NCT00500656|FG003|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
10887491|NCT00500656|OG000|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
10887492|NCT00500656|OG001|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
10887493|NCT00500656|EG000|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant+ oral placebo in the controlled phase and experienced adverse events while participating in the controlled phase
10887494|NCT00500656|EG001|Reported Event|Controlled Phase- Tranexamic Acid (Randomized Subjects)|Patients who were randomized to Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
10887495|NCT00500656|EG002|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
10887496|NCT00500656|EG003|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant+ oral placebo or Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
10887497|NCT00500656|EG004|Reported Event|Open Label Extension Phase (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase and Open label extension phase.
10887498|NCT00500656|EG005|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
10887499|NCT00500760|BG000|Baseline|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
10887500|NCT00500760|BG001|Baseline|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
10887501|NCT00500760|BG002|Baseline|Total|Total of all reporting groups
10887502|NCT00500760|FG000|Participant Flow|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
10887503|NCT00500760|FG001|Participant Flow|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
10887504|NCT00500760|OG000|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
10887505|NCT00500760|OG001|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
10887506|NCT00500760|EG000|Reported Event|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
10887507|NCT00500760|EG001|Reported Event|Chemotherapy Plus Radiotherapy|
10914683|NCT00632463|FG001|Participant Flow|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
10914684|NCT00632463|FG002|Participant Flow|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
11067149|NCT01395758|BG001|Baseline|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
11067150|NCT01395758|BG002|Baseline|Total|Total of all reporting groups
11067151|NCT01395758|FG000|Participant Flow|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg twice daily (BID) (total daily dose 720 mg) plus erlotinib 150 mg once daily (QD), tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
11067152|NCT01395758|FG001|Participant Flow|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the Crossover Arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
11067153|NCT01395758|FG002|Participant Flow|Crossover Arm|"Following radiographically confirmed progression, subjects in the Chemotherapy Arm had the option to enroll in the Crossover Arm to receive tivantinib plus erlotinib.~Crossover subjects were treated with tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity."
11067154|NCT01395758|OG000|Outcome|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
11067155|NCT01395758|OG001|Outcome|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
11067156|NCT01395758|OG000|Outcome|Tivantinib Plus Erlotinib Crossover Period|Following radiographically-confirmed progression, subjects randomly assigned to receive chemotherapy had the option to receive erlotinib plus tivantinib and were followed for post-progression objective response rate. Subjects who elected to crossover followed the Erlotinib plus Tivantinib Arm Schedule of Visits, following a post-chemotherapy 21-day washout period, until discontinuation criteria were met.
11067157|NCT01395758|EG000|Reported Event|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
11067158|NCT01395758|EG001|Reported Event|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
11067159|NCT01395784|BG000|Baseline|Withing-subjects, Placebo-Controlled|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
11067160|NCT01395784|FG000|Participant Flow|Withing-subjects, Placebo-Controlled|"Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.~pioglitazone: A PPARγ agonist, also marketed as Actos."
11067161|NCT01395784|OG000|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
11067162|NCT01395784|EG000|Reported Event|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
11067163|NCT01395797|BG000|Baseline|Placebo - Heroin|"Control condition for active arms.~Placebo: Placebo - Heroin"
11067164|NCT01395797|BG001|Baseline|Pio Low Dose - Heroin|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067165|NCT01395797|BG002|Baseline|Pio High Dose - Heroin|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067166|NCT01395797|BG003|Baseline|Placebo - Nicotine|"Control condition for active arms.~Pioglitazone: 0, 15, and 45 mg per day."
11067167|NCT01395797|BG004|Baseline|Pio Low Dose - Nicotine|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067168|NCT01395797|BG005|Baseline|Pio High Dose - Nicotine|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067169|NCT01395797|BG006|Baseline|Total|Total of all reporting groups
11067170|NCT01395797|FG000|Participant Flow|Placebo - Heroin|"Control condition for active arms.~Placebo: Placebo - Heroin"
11067171|NCT01395797|FG001|Participant Flow|Pio Low Dose - Heroin|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067172|NCT01395797|FG002|Participant Flow|Pio High Dose - Heroin|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067173|NCT01395797|FG003|Participant Flow|Placebo - Nicotine|"Control condition for active arms.~Pioglitazone: 0, 15, and 45 mg per day."
11067174|NCT01395797|FG004|Participant Flow|Pio Low Dose - Nicotine|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067175|NCT01395797|FG005|Participant Flow|Pio High Dose - Nicotine|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067176|NCT01395797|OG000|Outcome|Placebo - Heroin|"Control condition for active arms.~Placebo: Placebo - Heroin"
11067177|NCT01395797|OG001|Outcome|Pio Low Dose- Heroin|Low dose of Pio comparator
11067178|NCT01395797|OG002|Outcome|Pio High Dose - Heroin|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067179|NCT01395797|OG003|Outcome|Placebo - Nicotine|"Control condition for active arms.~Pioglitazone: 0, 15, and 45 mg per day."
11067180|NCT01395797|OG004|Outcome|Pio Low Dose- Nicotine|Low dose Pio comparator.
11067181|NCT01395797|OG005|Outcome|Pio High Dose - Nicotine|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067182|NCT01395797|OG000|Outcome|Placebo - Heroin|"Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of heroin.~Placebo: Placebo"
11067183|NCT01395797|OG001|Outcome|Pio Low Dose- Heroin|Participants will be maintained on 15 mg of PIO prior to assessing the abuse liability of heroin.
11067184|NCT01395797|OG002|Outcome|Pio High Dose - Heroin|Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin.
11067185|NCT01395797|OG003|Outcome|Placebo - Nicotine|Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine.
11067186|NCT01395797|OG004|Outcome|Pio Low Dose- Nicotine|Participants will be maintained on 15 mg of PIO prior to assessing the abuse liability of nicotine.
11067187|NCT01395797|OG005|Outcome|Pio High Dose - Nicotine|Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine
11067188|NCT01395797|EG000|Reported Event|Placebo - Heroin|"Control condition for active arms.~Placebo: Placebo - Heroin"
11067189|NCT01395797|EG001|Reported Event|Pio Low Dose - Heroin|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067190|NCT01395797|EG002|Reported Event|Pio High Dose - Heroin|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067191|NCT01395797|EG003|Reported Event|Placebo - Nicotine|"Control condition for active arms.~Pioglitazone: 0, 15, and 45 mg per day."
11067192|NCT01395797|EG004|Reported Event|Pio Low Dose - Nicotine|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11233684|NCT02430389|OG000|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
10914685|NCT00632463|OG000|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
11067193|NCT01395797|EG005|Reported Event|Pio High Dose - Nicotine|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
11067194|NCT01395810|BG000|Baseline|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067195|NCT01395810|BG001|Baseline|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067196|NCT01395810|BG002|Baseline|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
10914686|NCT00632463|OG001|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
11067197|NCT01395810|BG003|Baseline|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
11067198|NCT01395810|BG004|Baseline|Total|Total of all reporting groups
11067199|NCT01395810|FG000|Participant Flow|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an intravenous (i.v.) bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067200|NCT01395810|FG001|Participant Flow|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067201|NCT01395810|FG002|Participant Flow|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067202|NCT01395810|FG003|Participant Flow|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
11067203|NCT01395810|OG000|Outcome|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067204|NCT01395810|OG001|Outcome|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067205|NCT01395810|OG002|Outcome|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067206|NCT01395810|OG003|Outcome|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
11067207|NCT01395810|OG004|Outcome|Total|Subjects received nonacog beta pegol as prophylaxis treatment or on-demand treatment. Subjects in the prophylaxis treatment received either 10 IU/kg once weekly, 40 IU/kg once weekly or 80 IU/kg once every second week. Subjects in the on-demand group were administered with a single dose of 40 IU/kg of nonacog beta pegol. Subjects with on-demand treatment and prophylaxis treatments who experienced a bleeding episode were to be treated with single dose of 40 IU/kg unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
11067208|NCT01395810|EG000|Reported Event|Prophylaxis 10 U/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an intravenous (i.v.) bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067209|NCT01395810|EG001|Reported Event|Prophylaxis 40 U/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067210|NCT01395810|EG002|Reported Event|Prophylaxis 80 U/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
11067211|NCT01395810|EG003|Reported Event|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
11067212|NCT01395823|BG000|Baseline|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
11067213|NCT01395823|BG001|Baseline|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
11067214|NCT01395823|BG002|Baseline|Total|Total of all reporting groups
11067215|NCT01395823|FG000|Participant Flow|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
11067216|NCT01395823|FG001|Participant Flow|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
11067217|NCT01395823|OG000|Outcome|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
11067218|NCT01395823|OG001|Outcome|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
11067219|NCT01395823|EG000|Reported Event|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
11067220|NCT01395823|EG001|Reported Event|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
11067221|NCT01395888|BG000|Baseline|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
11233685|NCT02430389|OG001|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
10914687|NCT00632463|OG002|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
11067222|NCT01395888|BG001|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
11067223|NCT01395888|BG002|Baseline|Total|Total of all reporting groups
11067224|NCT01395888|FG000|Participant Flow|Salb/Alb + IBr|Participants were provided with an inhaled short-acting beta2-receptor agonist, salbutamol/albuterol (Salb/Alb), for use as needed throughout the Run-in Period for relief of chronic obstructive pulmonary disease (COPD) symptoms. Ipratropium bromide (IBr) was permitted during the Run-in Period and for up to 4 hours prior to Randomization (Visit 2) if the participant was on a stable dose prior to Screening (Visit 1). Following randomization, IBr was not permitted during exposure to study treatment.
11067225|NCT01395888|FG001|Participant Flow|FF/VI 100/25 µg|Participants (par.) self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
11067226|NCT01395888|FG002|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
11067227|NCT01395888|OG000|Outcome|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
11067228|NCT01395888|OG001|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
11067229|NCT01395888|EG000|Reported Event|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
11067230|NCT01395888|EG001|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
11067231|NCT01395901|BG000|Baseline|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
11067232|NCT01395901|BG001|Baseline|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
11067233|NCT01395901|BG002|Baseline|Total|Total of all reporting groups
11067234|NCT01395901|FG000|Participant Flow|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
11067235|NCT01395901|FG001|Participant Flow|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
11067236|NCT01395901|OG000|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
11067237|NCT01395901|OG001|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
11067238|NCT01395901|EG000|Reported Event|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
11067239|NCT01395901|EG001|Reported Event|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
11067240|NCT01395914|BG000|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
10914688|NCT00632463|EG000|Reported Event|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
11067241|NCT01395914|BG001|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11067242|NCT01395914|BG002|Baseline|Total|Total of all reporting groups
11067243|NCT01395914|FG000|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11067244|NCT01395914|FG001|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11067245|NCT01395914|OG000|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11067246|NCT01395914|OG001|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11067247|NCT01395914|EG000|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11067248|NCT01395914|EG001|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
11067249|NCT01395966|BG000|Baseline|DF289|"Ear drops~DF289: Ear drops"
11067250|NCT01395966|BG001|Baseline|DF277|"Ear drops~DF277: Ear drops"
11067251|NCT01395966|BG002|Baseline|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
11067252|NCT01395966|BG003|Baseline|Total|Total of all reporting groups
11067253|NCT01395966|FG000|Participant Flow|DF289|"Ear drops~DF289: Ear drops"
11067254|NCT01395966|FG001|Participant Flow|DF277|"Ear drops~DF277: Ear drops"
11067255|NCT01395966|FG002|Participant Flow|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
11067256|NCT01395966|OG000|Outcome|DF289|"Ear drops~DF289: Ear drops"
11067257|NCT01395966|OG001|Outcome|DF277|"Ear drops~DF277: Ear drops"
11067258|NCT01395966|OG002|Outcome|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
11067259|NCT01395966|EG000|Reported Event|DF289|"Ear drops~DF289: Ear drops"
11067260|NCT01395966|EG001|Reported Event|DF277|"Ear drops~DF277: Ear drops"
11067261|NCT01395966|EG002|Reported Event|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
11067262|NCT01396005|BG000|Baseline|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
11067263|NCT01396005|BG001|Baseline|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
11067264|NCT01396005|BG002|Baseline|Total|Total of all reporting groups
10914689|NCT00632463|EG001|Reported Event|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
11067265|NCT01396005|FG000|Participant Flow|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
11067266|NCT01396005|FG001|Participant Flow|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
11067267|NCT01396005|OG000|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
11067268|NCT01396005|OG001|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
11067269|NCT01396005|OG000|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
11067270|NCT01396005|OG001|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
11067271|NCT01396005|EG000|Reported Event|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
11067272|NCT01396005|EG001|Reported Event|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
11067273|NCT01396044|BG000|Baseline|Electronic Checklist|Electronic checklist
11067274|NCT01396044|BG001|Baseline|Verbal Prompting|Verbal prompting with written checklist
11067275|NCT01396044|BG002|Baseline|Total|Total of all reporting groups
11067276|NCT01396044|FG000|Participant Flow|Electronic Checklist|Electronic checklist
11067277|NCT01396044|FG001|Participant Flow|Verbal Prompting|Verbal prompting with written checklist
11067278|NCT01396044|OG000|Outcome|Electronic Checklist|Electronic checklist
11067279|NCT01396044|OG001|Outcome|Verbal Prompting|Verbal prompting with written checklist
11067280|NCT01396044|EG000|Reported Event|Electronic Checklist|Electronic checklist
11067281|NCT01396044|EG001|Reported Event|Verbal Prompting|Verbal prompting with written checklist
11067282|NCT01396057|BG000|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11067283|NCT01396057|BG001|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
11067284|NCT01396057|BG002|Baseline|Total|Total of all reporting groups
11067285|NCT01396057|FG000|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11067286|NCT01396057|FG001|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
11067287|NCT01396057|OG000|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11067288|NCT01396057|OG001|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
11067289|NCT01396057|EG000|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11067290|NCT01396057|EG001|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
11067291|NCT01396070|BG000|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
11067292|NCT01396070|FG000|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
11067293|NCT01396070|OG000|Outcome|Overall Response Rate (%)|Overall Response Rate of all patients
11067294|NCT01396070|OG000|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
11067295|NCT01396070|EG000|Reported Event|All Participants|All reported AE's on trial
11067296|NCT01396083|BG000|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
10914690|NCT00632463|EG002|Reported Event|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
11067297|NCT01396083|BG001|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
11067298|NCT01396083|BG002|Baseline|Total|Total of all reporting groups
11067299|NCT01396083|FG000|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11067300|NCT01396083|FG001|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
11067301|NCT01396083|OG000|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11067302|NCT01396083|OG001|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
11067303|NCT01396083|EG000|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
11067304|NCT01396083|EG001|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
11067305|NCT01396148|BG000|Baseline|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
11067306|NCT01396148|FG000|Participant Flow|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
11067307|NCT01396148|OG000|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
11067308|NCT01396148|OG000|Outcome|Sunitinib: Lower Exposure|Participants who received Sunitinib capsules orally at a dose based on BSA (minimum dose of 15 mg/m^2 up to a maximum dose of 30 mg/m^2 once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) and had total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) < the median Ctrough value
11067309|NCT01396148|OG001|Outcome|Sunitinib: Higher Exposure|Participants who received Sunitinib capsules orally at a dose based on BSA (minimum dose of 15 mg/m^2 up to a maximum dose of 30 mg/m^2 once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) and had total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) >= the median Ctrough value
11067310|NCT01396148|EG000|Reported Event|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
11067311|NCT01396161|BG000|Baseline|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
11067312|NCT01396161|BG001|Baseline|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
11067313|NCT01396161|BG002|Baseline|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
11067314|NCT01396161|BG003|Baseline|PF-05175157 100 mg QD -HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
11067315|NCT01396161|BG004|Baseline|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules PF-05175157 QD for 14 days
11067316|NCT01396161|BG005|Baseline|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
11067317|NCT01396161|BG006|Baseline|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067318|NCT01396161|BG007|Baseline|Total|Total of all reporting groups
11067319|NCT01396161|FG000|Participant Flow|Placebo - Healthy and Overweight Participants (HOV)|HOV participants administered orally matched placebo capsules once daily (QD) for 14 days
11067320|NCT01396161|FG001|Participant Flow|Placebo - Type 2 Diabetes Mellitus Participants (T2DM)|T2DM participants administered orally matched placebo capsules QD for 14 days
11067321|NCT01396161|FG002|Participant Flow|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 milligram (mg) capsules of PF-05175157 QD for 14 days
11067322|NCT01396161|FG003|Participant Flow|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
11067323|NCT01396161|FG004|Participant Flow|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067324|NCT01396161|FG005|Participant Flow|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 twice daily (BID) for 14 days
11067325|NCT01396161|FG006|Participant Flow|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067326|NCT01396161|OG000|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
11067327|NCT01396161|OG001|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
11067328|NCT01396161|OG002|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
11067329|NCT01396161|OG003|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
11067330|NCT01396161|OG004|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067331|NCT01396161|OG005|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
11067332|NCT01396161|OG006|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067333|NCT01396161|OG000|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
11067334|NCT01396161|OG001|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
11067335|NCT01396161|OG002|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067336|NCT01396161|OG003|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
11067337|NCT01396161|OG004|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067338|NCT01396161|EG000|Reported Event|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
11067339|NCT01396161|EG001|Reported Event|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
11067340|NCT01396161|EG002|Reported Event|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
11067341|NCT01396161|EG003|Reported Event|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
11067342|NCT01396161|EG004|Reported Event|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067343|NCT01396161|EG005|Reported Event|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
11067344|NCT01396161|EG006|Reported Event|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
11067345|NCT01396187|BG000|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067346|NCT01396187|BG001|Baseline|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067347|NCT01396187|BG002|Baseline|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
11067348|NCT01396187|BG003|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067349|NCT01396187|BG004|Baseline|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067350|NCT01396187|BG005|Baseline|Total|Total of all reporting groups
11067351|NCT01396187|FG000|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067352|NCT01396187|FG001|Participant Flow|PF-05231023 5 mg|PF-05231023 5 mg (milligram) intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067353|NCT01396187|FG002|Participant Flow|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
11067354|NCT01396187|FG003|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067355|NCT01396187|FG004|Participant Flow|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067356|NCT01396187|OG000|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067357|NCT01396187|OG001|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067358|NCT01396187|OG002|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
11067359|NCT01396187|OG003|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067360|NCT01396187|OG004|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067361|NCT01396187|OG000|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067362|NCT01396187|OG001|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
11067363|NCT01396187|OG002|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067364|NCT01396187|OG003|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067365|NCT01396187|EG000|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067366|NCT01396187|EG001|Reported Event|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067367|NCT01396187|EG002|Reported Event|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
11067368|NCT01396187|EG003|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067369|NCT01396187|EG004|Reported Event|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
11067370|NCT01396226|BG000|Baseline|AZD2927|AZD2927 solution for infusion
11067371|NCT01396226|BG001|Baseline|PLACEBO|Placebo solution for infusion
11067372|NCT01396226|BG002|Baseline|Total|Total of all reporting groups
11067373|NCT01396226|FG000|Participant Flow|AZD2927|AZD2927 solution for infusion
11067374|NCT01396226|FG001|Participant Flow|PLACEBO|Placebo solution for infusion
11067375|NCT01396226|OG000|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
11067376|NCT01396226|OG001|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
11067377|NCT01396226|EG000|Reported Event|AZD2927|AZD2927 solution for infusion
11067378|NCT01396226|EG001|Reported Event|PLACEBO|Placebo solution for infusion
11067379|NCT01396239|BG000|Baseline|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
11067380|NCT01396239|BG001|Baseline|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
11067381|NCT01396239|BG002|Baseline|Placebo|Placebo: phosphate buffered saline solution identical in appearance to eteplirsen for 24 weeks
11067382|NCT01396239|BG003|Baseline|Total|Total of all reporting groups
11067383|NCT01396239|FG000|Participant Flow|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
11067384|NCT01396239|FG001|Participant Flow|Placebo - Week 12 Biopsy|Placebo for 24 Weeks with muscle Biopsy at Week 12
11067385|NCT01396239|FG002|Participant Flow|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
11067386|NCT01396239|FG003|Participant Flow|Placebo - Week 24 Biopsy|Placebo for 24 weeks with muscle biopsy at Week 24
11067387|NCT01396239|OG000|Outcome|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen - Biopsied after 24 weeks of dosing
11067388|NCT01396239|OG001|Outcome|Placebo - Week 24 Biopsy|Placebo: Biopsied after 24 weeks of dosing
11067389|NCT01396239|OG002|Outcome|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen - Biopsied after 12 weeks of dosing
11067390|NCT01396239|OG003|Outcome|Placebo - Week 12 Biopsy|Placebo - Biopsied after 12 weeks of dosing
11067391|NCT01396239|OG000|Outcome|30 mg/kg Eteplirsen|30 mg/kg eteplirsen for 24 weeks
11067392|NCT01396239|OG001|Outcome|50 mg/kg Eteplirsen|50 mg/kg eteplirsen for 24 weeks
11067393|NCT01396239|OG002|Outcome|Placebo|Placebo for 24 weeks
11067394|NCT01396239|OG000|Outcome|30mg/kg Eteplirsen|30mg/kg eteplirsen for 24 weeks
11067395|NCT01396239|OG001|Outcome|50mg/kg Eteplirsen|50mg/kg eteplirsen for 24 weeks
11067396|NCT01396239|OG000|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
11067397|NCT01396239|OG001|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
11067398|NCT01396239|OG002|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
11067399|NCT01396239|EG000|Reported Event|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
11067400|NCT01396239|EG001|Reported Event|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
11067401|NCT01396239|EG002|Reported Event|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
11067402|NCT01396265|BG000|Baseline|Overall Study|This was a open-label, two period, fixed sequence trial clinical phase I trial in healthy male volunteers.
11067403|NCT01396265|FG000|Participant Flow|Overall Group|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
11067404|NCT01396265|OG000|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
11067405|NCT01396265|OG001|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
11067406|NCT01396265|EG000|Reported Event|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
11067407|NCT01396265|EG001|Reported Event|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
11067408|NCT01396317|BG000|Baseline|Tocilizumab + Corticosteroid Taper|"All subjects will receive the open-label active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.~Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling."
11067409|NCT01396317|BG001|Baseline|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial, or failed to meet inclusion criteria, served as a comparator group.These patients were treated contemporaneously with the comparator group by a single rheumatologist with expertise in PMR and received glucocorticoids alone, tapered at the treating physician's discretion, as is the standard of care in PMR.
11067410|NCT01396317|BG002|Baseline|Total|Total of all reporting groups
11067411|NCT01396317|FG000|Participant Flow|Tocilizumab + Corticosteroid Taper|In a single-center open-label study, subjects with newly diagnosed PMR (Healey criteria) and prior treatment with <1 month of corticosteroids (CS) were treated with TCZ 8mg/kg IV monthly for 12 months plus a rapid CS taper. Subjects were followed for 15 months. Those with concurrent GCA or those treated with >30mg prednisone were excluded.
11067412|NCT01396317|FG001|Participant Flow|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial or failed to meet inclusion criteria served as a control group. These patients were treated contemporaneously by a single rheumatologist with expertise in PMR and received CS alone, tapered at the treating physician's discretion.
11067413|NCT01396317|OG000|Outcome|Tocilizumab + Corticosteroid Taper|In a single-center open-label study, subjects with newly diagnosed PMR (Healey criteria) and prior treatment with <1 month of corticosteroids (CS) were treated with TCZ 8mg/kg IV monthly for 12 months plus a rapid CS taper. Subjects were followed for 15 months. Those with concurrent GCA or those treated with >30mg prednisone were excluded.
11067414|NCT01396317|OG001|Outcome|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial or failed to meet inclusion criteria served as a control group. These patients were treated contemporaneously by a single rheumatologist with expertise in PMR and received CS alone, tapered at the treating physician's discretion.
11067415|NCT01396317|OG000|Outcome|Tocilizumab|"This is a single-arm study. All subjects will receive the active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.~Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling."
11067416|NCT01396317|OG000|Outcome|Tocilizumab + Corticosteroid Taper|"All subjects will receive the open-label active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.~Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling."
11067417|NCT01396317|OG001|Outcome|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial, or failed to meet inclusion criteria, served as a comparator group.These patients were treated contemporaneously with the comparator group by a single rheumatologist with expertise in PMR and received glucocorticoids alone, tapered at the treating physician's discretion, as is the standard of care in PMR.
11067418|NCT01396317|EG000|Reported Event|Tocilizumab + Corticosteroid Taper|In a single-center open-label study, subjects with newly diagnosed PMR (Healey criteria) and prior treatment with <1 month of corticosteroids (CS) were treated with TCZ 8mg/kg IV monthly for 12 months plus a rapid CS taper. Subjects were followed for 15 months. Those with concurrent GCA or those treated with >30mg prednisone were excluded.
11067419|NCT01396382|BG000|Baseline|Imaging/Scans|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
11067420|NCT01396382|FG000|Participant Flow|68Ga-DOTATATE PET Scan|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
11067421|NCT01396382|OG000|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE PET scan will be administered to patients in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
11067422|NCT01396382|OG000|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE will be administered to patient in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
11067423|NCT01396382|EG000|Reported Event|68Ga-DOTATATE PET Scan|Patients will receive 68Ga-DOTATATE PET scans. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
11067424|NCT01396395|BG000|Baseline|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
11067425|NCT01396395|BG001|Baseline|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
11067426|NCT01396395|BG002|Baseline|Total|Total of all reporting groups
11067427|NCT01396395|FG000|Participant Flow|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 milligram (mg) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors (ACEIs) as permitted by disease condition or as per standard local practices or prescribed per discretion of the investigators.
11067428|NCT01396395|FG001|Participant Flow|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
11067429|NCT01396395|OG000|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
11067430|NCT01396395|OG001|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
11067431|NCT01396395|OG000|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
11067432|NCT01396395|OG000|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
11067433|NCT01396395|EG000|Reported Event|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
11067434|NCT01396395|EG001|Reported Event|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
11067435|NCT01396421|BG000|Baseline|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
11067436|NCT01396421|BG001|Baseline|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
11067437|NCT01396421|BG002|Baseline|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
11067438|NCT01396421|BG003|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
11067439|NCT01396421|BG004|Baseline|Total|Total of all reporting groups
11067440|NCT01396421|FG000|Participant Flow|Brexpiprazole 4 mg|"Brexpiprazole 4 milligram (mg) tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
11067441|NCT01396421|FG001|Participant Flow|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
11067442|NCT01396421|FG002|Participant Flow|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
11067443|NCT01396421|FG003|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
11067444|NCT01396421|OG000|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
11067445|NCT01396421|OG001|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
11067446|NCT01396421|OG002|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks
11067447|NCT01396421|OG003|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
11067448|NCT01396421|OG000|Outcome|Brexpiprazole 4 mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
11067449|NCT01396421|OG002|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
11067450|NCT01396421|OG001|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5)."
11067451|NCT01396421|OG002|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
11067452|NCT01396421|OG000|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
11067453|NCT01396421|OG001|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
11067454|NCT01396421|OG001|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a r5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
11067455|NCT01396421|OG001|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
11067456|NCT01396421|OG000|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2"
11067457|NCT01396421|OG001|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
11067458|NCT01396421|OG001|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day by Day 5."
11067459|NCT01396421|OG000|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
11067460|NCT01396421|OG001|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of placebo over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
11067461|NCT01396421|OG003|Outcome|Placebo|Placebo tablet once daily for 6 weeks
11067462|NCT01396421|EG000|Reported Event|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
11067463|NCT01396421|EG001|Reported Event|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
11067464|NCT01396421|EG002|Reported Event|Brexpiprazile 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
11067465|NCT01396421|EG003|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
11067466|NCT01396434|BG000|Baseline|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
11067467|NCT01396434|BG001|Baseline|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
11067468|NCT01396434|BG002|Baseline|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
11067469|NCT01396434|BG003|Baseline|Total|Total of all reporting groups
11067470|NCT01396434|FG000|Participant Flow|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
11067471|NCT01396434|FG001|Participant Flow|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
11067472|NCT01396434|FG002|Participant Flow|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
11067473|NCT01396434|OG000|Outcome|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
11067474|NCT01396434|OG001|Outcome|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
11067475|NCT01396434|OG002|Outcome|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
11067476|NCT01396434|EG000|Reported Event|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
11067477|NCT01396434|EG001|Reported Event|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
11067478|NCT01396434|EG002|Reported Event|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
11067479|NCT01396447|BG000|Baseline|Placebo|Participants received placebo orally once a day for 8 weeks.
11067480|NCT01396447|BG001|Baseline|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
11067481|NCT01396447|BG002|Baseline|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
11067482|NCT01396447|BG003|Baseline|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
11067483|NCT01396447|BG004|Baseline|Total|Total of all reporting groups
11067484|NCT01396447|FG000|Participant Flow|Placebo|Participants received placebo orally once a day for 8 weeks.
11067485|NCT01396447|FG001|Participant Flow|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
11067486|NCT01396447|FG002|Participant Flow|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
11067487|NCT01396447|FG003|Participant Flow|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
11067488|NCT01396447|OG000|Outcome|Placebo|Participants received placebo orally once a day for 8 weeks.
11067489|NCT01396447|OG001|Outcome|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
11067490|NCT01396447|OG002|Outcome|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
11067491|NCT01396447|OG003|Outcome|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
11067492|NCT01396447|EG000|Reported Event|Placebo|Participants received placebo orally once a day for 8 weeks.
11067493|NCT01396447|EG001|Reported Event|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
11067494|NCT01396447|EG002|Reported Event|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
11067495|NCT01396447|EG003|Reported Event|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
11067496|NCT01396486|BG000|Baseline|Omega-3/Placebo|"Combination Omega-3 and Placebo treatment.~Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules."
11067497|NCT01396486|BG001|Baseline|Placebo/Inositol|"Combination Placebo and Inositol treatment.~Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study."
11067498|NCT01396486|BG002|Baseline|Omega-3/Inositol|"Combination Omega-3 and Inositol treatment.~Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.~Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study."
11067499|NCT01396486|BG003|Baseline|Total|Total of all reporting groups
11067500|NCT01396486|FG000|Participant Flow|Omega-3/Placebo|"Combination Omega-3 and Placebo treatment.~Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules."
11067501|NCT01396486|FG001|Participant Flow|Placebo/Inositol|"Combination Placebo and Inositol treatment.~Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study."
11067502|NCT01396486|FG002|Participant Flow|Omega-3/Inositol|"Combination Omega-3 and Inositol treatment.~Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.~Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study."
11067503|NCT01396486|OG000|Outcome|Omega-3/Placebo|"Combination Omega-3 and Placebo treatment.~Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules."
11067504|NCT01396486|OG001|Outcome|Placebo/Inositol|"Combination Placebo and Inositol treatment.~Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study."
11067505|NCT01396486|OG002|Outcome|Omega-3/Inositol|"Combination Omega-3 and Inositol treatment.~Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.~Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study."
11067506|NCT01396486|EG000|Reported Event|Omega-3/Placebo|"Combination Omega-3 and Placebo treatment.~Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules."
11067507|NCT01396486|EG001|Reported Event|Placebo/Inositol|"Combination Placebo and Inositol treatment.~Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study."
11173489|NCT02015819|BG003|Baseline|Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11067508|NCT01396486|EG002|Reported Event|Omega-3/Inositol|"Combination Omega-3 and Inositol treatment.~Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.~Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study."
11067509|NCT01396512|BG000|Baseline|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
11067510|NCT01396512|BG001|Baseline|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
11067511|NCT01396512|BG002|Baseline|Total|Total of all reporting groups
11067512|NCT01396512|FG000|Participant Flow|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
11067513|NCT01396512|FG001|Participant Flow|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
11067514|NCT01396512|OG000|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
11067515|NCT01396512|OG001|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
11067516|NCT01396512|EG000|Reported Event|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
11067517|NCT01396512|EG001|Reported Event|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
11067518|NCT01396525|BG000|Baseline|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
11173490|NCT02015819|BG004|Baseline|Total|Total of all reporting groups
11067519|NCT01396525|FG000|Participant Flow|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
11067520|NCT01396525|OG000|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
11067521|NCT01396525|OG000|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
11067522|NCT01396525|OG000|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
11067523|NCT01396525|OG001|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
11067524|NCT01396525|OG002|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
11067525|NCT01396525|EG000|Reported Event|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
11067526|NCT01396551|BG000|Baseline|Transponder Implantation|Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
11067527|NCT01396551|FG000|Participant Flow|Transponder Implantation|Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
11067528|NCT01396551|OG000|Outcome|Transponder Implantation|Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
11067529|NCT01396551|EG000|Reported Event|Transponder Implantation|Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
11067530|NCT01396837|BG000|Baseline|RedDress Wound Care System (RD1)|"RD1 is a biologic autologous wound care product which is comprised of the patient whole blood and produced in the point of care using the RD1 kit~RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment"
11067531|NCT01396837|FG000|Participant Flow|RedDress Wound Care System (RD1)|"RD1 is a biologic autologous wound care product which is comprised of the patient whole blood and produced in the point of care using the RD1 kit~RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment"
11067532|NCT01396837|OG000|Outcome|RedDress Wound Care System (RD1)|"RD1 is a biologic autologous wound care product which is comprised of the patient whole blood and produced in the point of care using the RD1 kit~RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment"
11067533|NCT01396837|EG000|Reported Event|RedDress Wound Care System (RD1)|"RD1 is a biologic autologous wound care product which is comprised of the patient whole blood and produced in the point of care using the RD1 kit~RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment"
11067534|NCT01397071|BG000|Baseline|Consumption of Beef Patty With or Without Avocado|Participants consumed 250 g cooked ground beef patty with or without 68 g fresh avocado added prior to ingestion.
11067535|NCT01397071|FG000|Participant Flow|Consumption of Beef Patty With or Without Avocado Added|Participants consumed 250 g cooked ground beef patty with or without avocado added prior to ingestion.
11067536|NCT01397071|OG000|Outcome|Participants Consumed 250 g Beef Patties Alone|Participants consumed 250 g beef patties without avocado added
11067537|NCT01397071|OG001|Outcome|Participants Consumed 250 g Beef Patties With Avocado Added|Participants consumed 250 g beef patties with 68 g avocado added prior to ingestion.
11067538|NCT01397071|OG000|Outcome|Consumption of Beef Patty Alone|Participants consumed 250 g beef patties without avocado added prior to ingestion.
11067539|NCT01397071|OG001|Outcome|Consumption of 250 g Beef Patty With Avocado Added|Participants consumed 250 g beef patties with 68 g avocado added prior to ingestion.
11067540|NCT01397071|EG000|Reported Event|Change in PAT After Consuming Beef Only|Change in peripheral arterial tonometry (PAT) after consuming meals consisting of a ground beef patty only.
11067541|NCT01397071|EG001|Reported Event|Change in PAT After Comsuming Beef With Avocado|Change in peripheral arterial tonometry (PAT) after consuming meals consisting of a ground beef patty with 68 grams of avocado added.
11067542|NCT01397084|BG000|Baseline|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
11067543|NCT01397084|FG000|Participant Flow|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
11067544|NCT01397084|OG000|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
11067545|NCT01397084|EG000|Reported Event|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
11067546|NCT01397253|BG000|Baseline|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
11067547|NCT01397253|BG001|Baseline|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
11067548|NCT01397253|BG002|Baseline|Total|Total of all reporting groups
11067549|NCT01397253|FG000|Participant Flow|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
11067550|NCT01397253|FG001|Participant Flow|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
11067551|NCT01397253|OG000|Outcome|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
11067552|NCT01397253|OG001|Outcome|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
11067553|NCT01397253|EG000|Reported Event|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
11067554|NCT01397253|EG001|Reported Event|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
11067555|NCT01397409|BG000|Baseline|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
11067556|NCT01397409|BG001|Baseline|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
11067557|NCT01397409|BG002|Baseline|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
11067558|NCT01397409|BG003|Baseline|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
11067559|NCT01397409|BG004|Baseline|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067560|NCT01397409|BG005|Baseline|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067561|NCT01397409|BG006|Baseline|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067562|NCT01397409|BG007|Baseline|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
11067563|NCT01397409|BG008|Baseline|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
11067564|NCT01397409|BG009|Baseline|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
11067565|NCT01397409|BG010|Baseline|Total|Total of all reporting groups
11226869|NCT02378714|FG003|Participant Flow|BASC + Active Varenicline|"Behavioral activation for smoking cessation plus active varenicline~Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.~BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.~Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11067566|NCT01397409|FG000|Participant Flow|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
11067567|NCT01397409|FG001|Participant Flow|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
11067568|NCT01397409|FG002|Participant Flow|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
11067569|NCT01397409|FG003|Participant Flow|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
11067570|NCT01397409|FG004|Participant Flow|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067571|NCT01397409|FG005|Participant Flow|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067572|NCT01397409|FG006|Participant Flow|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067573|NCT01397409|FG007|Participant Flow|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
11067574|NCT01397409|FG008|Participant Flow|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
11067575|NCT01397409|FG009|Participant Flow|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
11067576|NCT01397409|OG000|Outcome|Stage 1 All Participants|Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
11067577|NCT01397409|OG000|Outcome|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
11067578|NCT01397409|OG001|Outcome|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
11067579|NCT01397409|OG002|Outcome|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
11067580|NCT01397409|OG003|Outcome|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
11067581|NCT01397409|OG000|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067582|NCT01397409|OG001|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067583|NCT01397409|OG002|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067584|NCT01397409|OG000|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
11067585|NCT01397409|OG001|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
11067586|NCT01397409|OG002|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
11067587|NCT01397409|EG000|Reported Event|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
11067588|NCT01397409|EG001|Reported Event|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
11067589|NCT01397409|EG002|Reported Event|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
11067590|NCT01397409|EG003|Reported Event|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
11067591|NCT01397409|EG004|Reported Event|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067592|NCT01397409|EG005|Reported Event|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067593|NCT01397409|EG006|Reported Event|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11067594|NCT01397409|EG007|Reported Event|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
11067595|NCT01397409|EG008|Reported Event|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
11067596|NCT01397409|EG009|Reported Event|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
11067597|NCT01397422|BG000|Baseline|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
11067598|NCT01397422|BG001|Baseline|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
11067599|NCT01397422|BG002|Baseline|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
11067600|NCT01397422|BG003|Baseline|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
11067601|NCT01397422|BG004|Baseline|Total|Total of all reporting groups
11067602|NCT01397422|FG000|Participant Flow|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
11067603|NCT01397422|FG001|Participant Flow|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
11067604|NCT01397422|FG002|Participant Flow|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
11067605|NCT01397422|FG003|Participant Flow|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
11067606|NCT01397422|OG000|Outcome|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
11067607|NCT01397422|OG001|Outcome|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
11067608|NCT01397422|OG002|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
11067609|NCT01397422|OG003|Outcome|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
11067610|NCT01397422|OG001|Outcome|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
11067611|NCT01397422|OG003|Outcome|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
11067612|NCT01397422|EG000|Reported Event|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
11067613|NCT01397422|EG001|Reported Event|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
11067614|NCT01397422|EG002|Reported Event|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
11067615|NCT01397422|EG003|Reported Event|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
11067616|NCT01397448|BG000|Baseline|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
11067617|NCT01397448|BG001|Baseline|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
11067618|NCT01397448|BG002|Baseline|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
11067619|NCT01397448|BG003|Baseline|Total|Total of all reporting groups
11067620|NCT01397448|FG000|Participant Flow|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
11067621|NCT01397448|FG001|Participant Flow|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
11067622|NCT01397448|FG002|Participant Flow|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
11067623|NCT01397448|OG000|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
11067624|NCT01397448|OG001|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
11067625|NCT01397448|OG002|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
11067626|NCT01397448|EG000|Reported Event|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
11067627|NCT01397448|EG001|Reported Event|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
11067628|NCT01397448|EG002|Reported Event|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
11067629|NCT01397461|BG000|Baseline|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
11067630|NCT01397461|BG001|Baseline|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
11067631|NCT01397461|BG002|Baseline|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
11067632|NCT01397461|BG003|Baseline|Total|Total of all reporting groups
11067633|NCT01397461|FG000|Participant Flow|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
11067634|NCT01397461|FG001|Participant Flow|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
11067635|NCT01397461|FG002|Participant Flow|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
11067636|NCT01397461|OG000|Outcome|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
10887508|NCT00500903|BG000|Baseline|PIC Dose Escalation|Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).
11067637|NCT01397461|OG001|Outcome|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
11067638|NCT01397461|OG002|Outcome|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
11067639|NCT01397461|EG000|Reported Event|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
11067640|NCT01397461|EG001|Reported Event|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
11067641|NCT01397461|EG002|Reported Event|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
11067642|NCT01397591|BG000|Baseline|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
11067643|NCT01397591|FG000|Participant Flow|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
11067644|NCT01397591|OG000|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
11067645|NCT01397591|OG000|Outcome|Ofatumumab in Combination With Bortezomib|"All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
11067646|NCT01397591|EG000|Reported Event|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
11067647|NCT01397617|BG000|Baseline|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
11067648|NCT01397617|BG001|Baseline|NobelActive External|"NobelActive External implant~NobelActive External implant"
11067649|NCT01397617|BG002|Baseline|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
11067650|NCT01397617|BG003|Baseline|Total|Total of all reporting groups
11067651|NCT01397617|FG000|Participant Flow|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
11067652|NCT01397617|FG001|Participant Flow|NobelActive External|"NobelActive External implant~NobelActive External implant"
11067653|NCT01397617|FG002|Participant Flow|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
11067654|NCT01397617|OG000|Outcome|NobelActive External|"NobelActive External implant~NobelActive External implant"
11067655|NCT01397617|OG001|Outcome|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
11067656|NCT01397617|OG002|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
11067657|NCT01397617|OG000|Outcome|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant: Dental implant"
11067658|NCT01397617|OG001|Outcome|NobelActive External|"NobelActive External implant~NobelActive External implant: Dental implant"
11067659|NCT01397617|OG002|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant: Dental implant"
11067660|NCT01397617|EG000|Reported Event|NobelActive External|"NobelActive External implant~NobelActive External implant"
11067661|NCT01397617|EG001|Reported Event|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
11067662|NCT01397617|EG002|Reported Event|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
11067663|NCT01397656|BG000|Baseline|CPR 30:2 Then CPR With Continuous Compressions|"30 chest compressions to 2 ventilations~Bystander CPR using 30:2 ratio versus continuous compression: Participants will use 2 CPR techniques, one with 30 compressions to 2 ventilations and the other with continuous compressions without ventilation"
11067664|NCT01397656|BG001|Baseline|CPR With Continuous Compressions Then CPR 30:2|"Continuous Chest Compressions without ventilation~Bystander CPR using 30:2 ratio versus continuous compression: Participants will use 2 CPR techniques, one with 30 compressions to 2 ventilations and the other with continuous compressions without ventilation"
11067665|NCT01397656|BG002|Baseline|Total|Total of all reporting groups
11067666|NCT01397656|FG000|Participant Flow|CPR 30:2 Then CPR With Continuous Compressions|"30 chest compressions to 2 ventilations, then continuous chest compressions~Bystander CPR using 30:2 ratio versus continuous compression: Participants will use 2 CPR techniques, one with 30 compressions to 2 ventilations and the other with continuous compressions without ventilation"
11226870|NCT02378714|OG000|Outcome|Standard Treatment + Placebo Varenicline|"Standard behavioral smoking cessation treatment plus placebo varenicline~Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
10887509|NCT00500903|BG001|Baseline|ECT Dose Escalation|Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).
11067667|NCT01397656|FG001|Participant Flow|CPR With Continuous Compressions Then CPR 30:2|"Continuous Chest Compressions without ventilation then CPR using 30:2 ratio~Bystander CPR using 30:2 ratio versus continuous compression: Participants will use 2 CPR techniques, one with 30 compressions to 2 ventilations and the other with continuous compressions without ventilation"
11067668|NCT01397656|OG000|Outcome|CPR 30:2|30 chest compressions to 2 ventilations
11067669|NCT01397656|OG001|Outcome|CPR With Continuous Compressions|"Continuous Chest Compressions without ventilation~Bystander CPR using 30:2 ratio versus continuous compression: Participants will use 2 CPR techniques, one with 30 compressions to 2 ventilations and the other with continuous compressions without ventilation"
11067670|NCT01397656|OG001|Outcome|CPR With Continuous Compressions|Continuous Chest Compressions without ventilation
11067671|NCT01397656|OG001|Outcome|CPR With Continuous Compressions|Continuous Chest Compressions
11067672|NCT01397656|EG000|Reported Event|CPR 30:2 Then CPR With Continuous Compressions|"30 chest compressions to 2 ventilations~Bystander CPR using 30:2 ratio versus continuous compression: Participants will use 2 CPR techniques, one with 30 compressions to 2 ventilations and the other with continuous compressions without ventilation"
11067673|NCT01397656|EG001|Reported Event|CPR With Continuous Compressions Then CPR 30:2|"Continuous Chest Compressions without ventilation~Bystander CPR using 30:2 ratio versus continuous compression: Participants will use 2 CPR techniques, one with 30 compressions to 2 ventilations and the other with continuous compressions without ventilation"
11067674|NCT01397747|BG000|Baseline|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
11067675|NCT01397747|FG000|Participant Flow|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
11067676|NCT01397747|OG000|Outcome|Multitarget DNA Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
11067677|NCT01397747|OG001|Outcome|FIT Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
11067678|NCT01397747|EG000|Reported Event|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
11067679|NCT01397786|BG000|Baseline|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067680|NCT01397786|BG001|Baseline|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067681|NCT01397786|BG002|Baseline|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067682|NCT01397786|BG003|Baseline|Total|Total of all reporting groups
10887510|NCT00500903|BG002|Baseline|Relative Bioavailability|Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).
10887511|NCT00500903|BG003|Baseline|Total|Total of all reporting groups
10887512|NCT00500903|FG000|Participant Flow|PIC Dose Escalation|Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).
10887513|NCT00500903|FG001|Participant Flow|ECT Dose Escalation|Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).
10887514|NCT00500903|FG002|Participant Flow|Relative Bioavailability|Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).
10887515|NCT00500903|OG000|Outcome|Alisertib 5 mg PIC QD 7D|Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).
10887516|NCT00500903|OG001|Outcome|Alisertib 10 mg PIC QD 7D|Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).
10887517|NCT00500903|OG002|Outcome|Alisertib 20 mg PIC QD 7D|Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).
10887518|NCT00500903|OG003|Outcome|Alisertib 40 mg PIC QD 7D|Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).
10887519|NCT00500903|OG004|Outcome|Alisertib 80 mg PIC QD 7D|Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
10887520|NCT00500903|OG005|Outcome|Alisertib 110 mg PIC QD 7D|Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10887521|NCT00500903|OG006|Outcome|Alisertib 150 mg PIC QD 7D|Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).
10887522|NCT00500903|OG007|Outcome|Alisertib 25 mg PIC QD 14D|Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).
10887523|NCT00500903|OG008|Outcome|Alisertib 25 mg PIC QD 21D|Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10887524|NCT00500903|OG009|Outcome|Alisertib 50 mg PIC QD 21D|Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).
10887525|NCT00500903|OG010|Outcome|Alisertib 70 mg PIC QD 21D|Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10887526|NCT00500903|OG011|Outcome|Alisertib 50 mg PIC BID 7D|Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).
10887527|NCT00500903|OG012|Outcome|Alisertib 60 mg PIC BID 7D|Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).
10887528|NCT00500903|OG013|Outcome|Alisertib 40 mg PIC BID 14D|Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10887529|NCT00500903|OG014|Outcome|Alisertib 10 mg ECT QD7|Alisertib 10 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).
10887530|NCT00500903|OG015|Outcome|Alisertib 20 mg ECT QD7|Alisertib 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).
11067683|NCT01397786|FG000|Participant Flow|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786 .
11067684|NCT01397786|FG001|Participant Flow|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067685|NCT01397786|FG002|Participant Flow|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067686|NCT01397786|OG000|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067687|NCT01397786|OG001|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067688|NCT01397786|OG002|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067689|NCT01397786|OG003|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067690|NCT01397786|OG001|Outcome|Prior Placebo|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067691|NCT01397786|OG002|Outcome|De Novo|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
11067692|NCT01397786|EG000|Reported Event|De Novo (Phase A)|"Participants underwent cross-titration to oral brexpiprazole for 4 weeks in Phase A. DeNovo participants in Phase A received brexpiprazole monotherapy starting dose of 2 mg daily at the conversion Week 4 visit (baseline visit of Phase B). Participants who received at least 1 dose of study drug were included in this phase.~NOTE: 12 participants from the trial P33110232 were excluded in this analysis."
11067693|NCT01397786|EG001|Reported Event|Prior Brexpiprazole (Phase B)|"Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.~NOTE: Six participants from the trial P33110231 were excluded in this analysis."
11067694|NCT01397786|EG002|Reported Event|Prior Placebo (Phase B)|"Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.~Participants who received at least 1 dose of study drug were included in this phase.~NOTE: One participant each from the trials P33110230 and P33110231 were excluded in this analysis."
11067695|NCT01397786|EG003|Reported Event|De Novo (Phase B)|"Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.~NOTE: Five participants from Phase B - Denovo were excluded in this analysis."
11067696|NCT01397825|BG000|Baseline|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067697|NCT01397825|BG001|Baseline|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067698|NCT01397825|BG002|Baseline|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11173491|NCT02015819|FG000|Participant Flow|Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11173492|NCT02015819|FG001|Participant Flow|Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11173493|NCT02015819|FG002|Participant Flow|Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11067699|NCT01397825|BG003|Baseline|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067700|NCT01397825|BG004|Baseline|Total|Total of all reporting groups
11067701|NCT01397825|FG000|Participant Flow|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067702|NCT01397825|FG001|Participant Flow|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067703|NCT01397825|FG002|Participant Flow|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067704|NCT01397825|FG003|Participant Flow|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067705|NCT01397825|FG004|Participant Flow|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
11067706|NCT01397825|OG000|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067707|NCT01397825|OG001|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067708|NCT01397825|OG002|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067709|NCT01397825|OG003|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067710|NCT01397825|OG000|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
11067711|NCT01397825|OG000|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067712|NCT01397825|OG001|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067713|NCT01397825|OG002|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
10914691|NCT00632489|BG000|Baseline|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
11067714|NCT01397825|EG000|Reported Event|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067715|NCT01397825|EG001|Reported Event|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067716|NCT01397825|EG002|Reported Event|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067717|NCT01397825|EG003|Reported Event|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
11067718|NCT01397851|BG000|Baseline|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
11067719|NCT01397851|BG001|Baseline|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
11067720|NCT01397851|BG002|Baseline|Total|Total of all reporting groups
11067721|NCT01397851|FG000|Participant Flow|Control|
11067722|NCT01397851|FG001|Participant Flow|Treatment|
11067723|NCT01397851|OG000|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
11067724|NCT01397851|OG001|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
11067725|NCT01397851|EG000|Reported Event|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
11067726|NCT01397851|EG001|Reported Event|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
11067727|NCT01397890|BG000|Baseline|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
11067728|NCT01397890|BG001|Baseline|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
11067729|NCT01397890|BG002|Baseline|Total|Total of all reporting groups
11067730|NCT01397890|FG000|Participant Flow|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
11067731|NCT01397890|FG001|Participant Flow|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
11067732|NCT01397890|OG000|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
11067733|NCT01397890|OG001|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
11067734|NCT01397890|EG000|Reported Event|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
11067735|NCT01397890|EG001|Reported Event|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
11067736|NCT01398059|BG000|Baseline|All Study Participants|All participants experienced all 3 conditions, in random order.
11067737|NCT01398059|FG000|Participant Flow|Sed, Sed With Breaks, Sed With Breaks and PA|"In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.~Sedentary condition~Sedentary with breaks condition~Sedentary with breaks and physical activity condition"
11067738|NCT01398059|FG001|Participant Flow|Sed, Sed With Breaks and PA, Sed With Breaks|"In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.~Sedentary condition~Sedentary with breaks and physical activity condition~Sedentary with breaks condition"
11067739|NCT01398059|FG002|Participant Flow|Sed With Breaks, Sed With Breaks and PA, Sed|"In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.~Sedentary with breaks and physical activity condition~Sedentary with breaks condition~Sedentary condition"
11067740|NCT01398059|FG003|Participant Flow|Sed With Breaks, Sed, Sed With Breaks and PA|"In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.~Sedentary with breaks condition~Sedentary condition~Sedentary with breaks and physical activity condition"
11067741|NCT01398059|FG004|Participant Flow|Sed With Breaks and PA, Sed, Sed With Breaks|"In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.~Sedentary with breaks and physical activity condition~Sedentary condition~Sedentary with breaks condition"
11067742|NCT01398059|FG005|Participant Flow|Sed With Breaks and PA, Sed With Breaks, Sed|"In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.~Sedentary with breaks and physical activity condition~Sedentary with breaks condition~Sedentary condition"
11067743|NCT01398059|OG000|Outcome|Sedentary|"In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.~Sedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour."
11067744|NCT01398059|OG001|Outcome|Sedentary With Breaks|"In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.~Sedentary With Breaks: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak."
11067745|NCT01398059|OG002|Outcome|Sedentary With Breaks and Physical Activity|"In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.~Sedentary With Breaks and Physical Activity: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon."
11067746|NCT01398059|EG000|Reported Event|Sedentary|"In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.~Sedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour."
11067747|NCT01398059|EG001|Reported Event|Sedentary With Breaks|"In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.~Sedentary With Breaks: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak."
11067748|NCT01398059|EG002|Reported Event|Sedentary With Breaks and Physical Activity|"In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.~Sedentary With Breaks and Physical Activity: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon."
11067749|NCT01398176|BG000|Baseline|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
11067750|NCT01398176|BG001|Baseline|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
11067751|NCT01398176|BG002|Baseline|Total|Total of all reporting groups
11067752|NCT01398176|FG000|Participant Flow|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
11067753|NCT01398176|FG001|Participant Flow|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
11067754|NCT01398176|OG000|Outcome|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
11067755|NCT01398176|OG001|Outcome|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
11067756|NCT01398176|EG000|Reported Event|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
11067757|NCT01398176|EG001|Reported Event|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
11067758|NCT01398280|BG000|Baseline|Aminocaproic Acid (ACA)|"Subjects will treat their facial skin twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess KLK activity and LL-37 expression.~Topical aminocaproic acid (ACA) mixed with Vanicream: 25% Aminocaproic acid cream twice daily for up to 12 weeks."
11067759|NCT01398280|BG001|Baseline|Vehicle Cream|"Subjects will apply vehicle twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess KLK activity and LL-37 expression.~Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks"
11067760|NCT01398280|BG002|Baseline|Total|Total of all reporting groups
11067761|NCT01398280|FG000|Participant Flow|Aminocaproic Acid (ACA)|"Subjects will treat their facial skin twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess KLK activity and LL-37 expression.~Topical aminocaproic acid (ACA) mixed with Vanicream: 25% Aminocaproic acid cream twice daily for up to 12 weeks."
11067762|NCT01398280|FG001|Participant Flow|Vehicle Cream|"Subjects will apply vehicle twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess KLK activity and LL-37 expression.~Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks"
11067763|NCT01398280|OG000|Outcome|Aminocaproic Acid (ACA)|"Subjects will treat their facial skin twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess KLK activity and LL-37 expression.~Topical aminocaproic acid (ACA) mixed with Vanicream: 25% Aminocaproic acid cream twice daily for up to 12 weeks."
11067764|NCT01398280|OG001|Outcome|Vehicle Cream|"Subjects will apply vehicle twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess KLK activity and LL-37 expression.~Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks"
11067765|NCT01398280|EG000|Reported Event|Aminocaproic Acid (ACA)|"Subjects will treat their facial skin twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess KLK activity and LL-37 expression.~Topical aminocaproic acid (ACA) mixed with Vanicream: 25% Aminocaproic acid cream twice daily for up to 12 weeks."
11067766|NCT01398280|EG001|Reported Event|Vehicle Cream|"Subjects will apply vehicle twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess KLK activity and LL-37 expression.~Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks"
11067767|NCT01398358|BG000|Baseline|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
11067768|NCT01398358|BG001|Baseline|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
11067769|NCT01398358|BG002|Baseline|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
11067770|NCT01398358|BG003|Baseline|Total|Total of all reporting groups
11067771|NCT01398358|FG000|Participant Flow|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
11067772|NCT01398358|FG001|Participant Flow|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
11067773|NCT01398358|FG002|Participant Flow|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
11067774|NCT01398358|OG000|Outcome|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
11067775|NCT01398358|OG001|Outcome|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
10914692|NCT00632489|BG001|Baseline|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
11067776|NCT01398358|OG002|Outcome|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
11067777|NCT01398358|EG000|Reported Event|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
11067778|NCT01398358|EG001|Reported Event|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
11067779|NCT01398358|EG002|Reported Event|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
11067780|NCT01398410|BG000|Baseline|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
11067781|NCT01398410|BG001|Baseline|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
11067782|NCT01398410|BG002|Baseline|Total|Total of all reporting groups
11067783|NCT01398410|FG000|Participant Flow|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
11067784|NCT01398410|FG001|Participant Flow|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
11067785|NCT01398410|OG000|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
11067786|NCT01398410|OG001|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
11067787|NCT01398410|EG000|Reported Event|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
11067788|NCT01398410|EG001|Reported Event|Rabeprazole10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
11067789|NCT01398475|BG000|Baseline|Entire Study Population|"Includes groups randomized to receive any of the following study drugs as the first intervention.~LY3009104 Reference Formulation (RF): 8-milligram (mg) dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~LY3009104 Test Formulation 1 (TF1), 20 micrometers (mcm): 8-mg dose of LY3009104 TF1 [one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 mcm] administered once in a fasted state.~LY3009104 Test Formulation 2 (TF2), 50 mcm, fasted: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~LY3009104 TF2, 50 mcm, fed: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal."
11067790|NCT01398475|FG000|Participant Flow|LY3009104 (LY) RF, LY 50-mcm Fed, LY 20-mcm, LY 50-mcm Fasted|"First intervention: 8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometers (mcm)] administered once with a high-fat, high calorie meal.~Third intervention: 8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
11067791|NCT01398475|FG001|Participant Flow|LY 20-mcm, LY RF, LY 50-mcm Fasted, LY 50-mcm Fed|"First intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~There was a washout period of 5 to 7 days between doses of study drug."
11067792|NCT01398475|FG002|Participant Flow|LY 50-mcm Fasted, LY 20-mcm, LY 50-mcm Fed, LY RF|"First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~Fourth intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
11067793|NCT01398475|FG003|Participant Flow|LY 50-mcm Fed, LY 50-mcm Fasted, LY RF, LY 20-mcm|"First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~Second intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~Fourth Intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
11067794|NCT01398475|OG000|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
11067795|NCT01398475|OG001|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
11067796|NCT01398475|OG002|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
11067797|NCT01398475|OG003|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
11067798|NCT01398475|EG000|Reported Event|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
11067799|NCT01398475|EG001|Reported Event|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometer (mcm)] administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
11067800|NCT01398475|EG002|Reported Event|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
11067801|NCT01398475|EG003|Reported Event|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
11067802|NCT01398514|BG000|Baseline|Active Medication|Escitalopram 10mg/day
11067803|NCT01398514|BG001|Baseline|Placebo|Matched pill placebo
11067804|NCT01398514|BG002|Baseline|Total|Total of all reporting groups
11067805|NCT01398514|FG000|Participant Flow|Active Medication|Escitalopram 10mg/day
11067806|NCT01398514|FG001|Participant Flow|Placebo|Matched pill placebo
11067807|NCT01398514|OG000|Outcome|Active Medication CS-|Escitalopram 10mg/day
11067808|NCT01398514|OG001|Outcome|Active Medication CS+|Matched pill placebo
11067809|NCT01398514|OG002|Outcome|Placebo CS-|
11067810|NCT01398514|OG003|Outcome|Placebo CS+|
11067811|NCT01398514|EG000|Reported Event|Active Medication|Escitalopram 10mg/day
11067812|NCT01398514|EG001|Reported Event|Placebo|Matched pill placebo
11067813|NCT01398566|BG000|Baseline|Gaming|Members of this group will play SuperBetter in addition to receiving standard medical care for persistent concussion symptoms
11067814|NCT01398566|FG000|Participant Flow|Gaming|Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
11067815|NCT01398566|OG000|Outcome|Gaming|Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
11067816|NCT01398566|EG000|Reported Event|Gaming|Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
11067817|NCT01398787|BG000|Baseline|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
11067818|NCT01398787|FG000|Participant Flow|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
11067819|NCT01398787|OG000|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
11067820|NCT01398787|OG001|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
11067821|NCT01398787|EG000|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 4 colors (gray, blue, green, pure hazel) worn in one eye, up to 10 minutes each
11067822|NCT01398787|EG001|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye, up to 10 minutes each
11067823|NCT01398943|BG000|Baseline|All COPD Patients|Patients with COPD
11067824|NCT01398943|BG001|Baseline|All Controls|Healthy age- and sex- matched controls
11067825|NCT01398943|BG002|Baseline|Total|Total of all reporting groups
11091767|NCT01536145|EG000|Reported Event|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) (adverse events from all dosing groups were combined as a whole)
11067826|NCT01398943|FG000|Participant Flow|COPD: AOC First, Then Placebo|"Patients with COPD~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) were assessed at baseline and 2 hours following ingestion of an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.~After a minimum of 2 days washout, patients returned to perform all measures again but were given microcrystalline cellulose capsules as a placebo."
11067827|NCT01398943|FG001|Participant Flow|COPD: Placebo First, Then AOC|"Patients with COPD~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) was assessed at baseline and 2 hours following ingestion of microcrystalline cellulose capsules as a placebo.~After a minimum of 2 days washout, patients returned to perform all measures again but were given an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid."
11067828|NCT01398943|FG002|Participant Flow|Controls: AOC First, Then Placebo|"Healthy age- and sex- matched controls~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) were assessed at baseline and 2 hours following ingestion of an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.~After a minimum of 2 days washout, subjects returned to perform all measures again but were given microcrystalline cellulose capsules as a placebo."
11067829|NCT01398943|FG003|Participant Flow|Controls: Placebo First, Then AOC|"Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) was assessed at baseline and 2 hours following ingestion of microcrystalline cellulose capsules as a placebo.~After a minimum of 2 days washout, subjects returned to perform all measures again but were given an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid."
11067830|NCT01398943|OG000|Outcome|All COPD Patients|Patients with COPD
11067831|NCT01398943|OG001|Outcome|All Controls|Healthy age- and sex- matched controls
11067832|NCT01398943|OG000|Outcome|All COPD Patients|"Patients with COPD~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
11067833|NCT01398943|OG001|Outcome|All Controls|"Healthy age- and sex- matched controls~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
11067834|NCT01398943|EG000|Reported Event|COPD Patients|"Patients with COPD~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
11067835|NCT01398943|EG001|Reported Event|Controls|"Healthy age- and sex- matched controls~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
11067836|NCT01398956|BG000|Baseline|Levetiracetam|Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
11067837|NCT01398956|FG000|Participant Flow|Levetiracetam|Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
11067838|NCT01398956|OG000|Outcome|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
11067839|NCT01398956|OG000|Outcome|Levetiracetam (FAS)|Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
11067840|NCT01398956|EG000|Reported Event|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
11067841|NCT01398982|BG000|Baseline|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
11067842|NCT01398982|BG001|Baseline|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
11067843|NCT01398982|BG002|Baseline|Total|Total of all reporting groups
11335656|NCT03554629|OG001|Outcome|FiCO2 During Mouth Closed Breathing Rate of 6|Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm.
10887531|NCT00500903|OG000|Outcome|Alisertib|Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period or alisertib 10 or 20 mg ECT, orally QD for 7 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).
10887532|NCT00500903|OG000|Outcome|PIC Dose Escalation|Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).
10887533|NCT00500903|OG001|Outcome|ECT Dose Escalation|Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).
10887534|NCT00500903|OG002|Outcome|Relative Bioavailability|Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).
10887535|NCT00500903|OG000|Outcome|Alisertib 40 mg PIC QD 7D|Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).
10887536|NCT00500903|OG001|Outcome|Alisertib 80 mg PIC QD 7D|Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
10887537|NCT00500903|OG002|Outcome|Alisertib 110 mg PIC QD 7D|Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10887538|NCT00500903|OG003|Outcome|Alisertib 150 mg PIC QD 7D|Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).
10887539|NCT00500903|OG000|Outcome|Alisertib 25 mg PIC QD 14D|Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).
10887540|NCT00500903|OG000|Outcome|Alisertib 25 mg PIC QD 21D|Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10887541|NCT00500903|OG001|Outcome|Alisertib 50 mg PIC QD 21D|Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).
10887542|NCT00500903|OG002|Outcome|Alisertib 70 mg PIC QD 21D|Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10887543|NCT00500903|OG000|Outcome|Alisertib 50 mg PIC BID 7D|Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).
10887544|NCT00500903|OG001|Outcome|Alisertib 60 mg PIC BID 7D|Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).
10887545|NCT00500903|OG000|Outcome|Alisertib 40 mg PIC BID 14D|Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10887546|NCT00500903|OG000|Outcome|Alisertib 40 mg ECT BID 7D|Alisertib 40 mg, Enteric-coated tablet (ECT), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period for 1 cycle.
10887547|NCT00500903|OG001|Outcome|Alisertib 40 mg PIC BID 7D|Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period for 1 cycle.
10887548|NCT00500903|EG000|Reported Event|PIC Dose Escalation|Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).
11335657|NCT03554629|OG002|Outcome|EtCO2 During Mouth Closed Breathing Rate of 24|Patient interface to sample gas for end tidal CO2 (EtCO2)capnography measurement under condition of closed mouth and respiration rate of 24 with supplemental O2 at 5lpm.
11335658|NCT03554629|OG003|Outcome|FiCO2 During Mouth Closed Breathing Rate of 24|Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of closed mouth and respiration rate of 24 with supplemental O2 at 5lpm.
11067844|NCT01398982|FG000|Participant Flow|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
11067845|NCT01398982|FG001|Participant Flow|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
11067846|NCT01398982|OG000|Outcome|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
11067847|NCT01398982|OG001|Outcome|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
11067848|NCT01398982|EG000|Reported Event|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
11067849|NCT01398982|EG001|Reported Event|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
11067850|NCT01399008|BG000|Baseline|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
11067851|NCT01399008|BG001|Baseline|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
11067852|NCT01399008|BG002|Baseline|Placebo|Placebo plus Allopurinol 300 mg
11067853|NCT01399008|BG003|Baseline|Total|Total of all reporting groups
11067854|NCT01399008|FG000|Participant Flow|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
11067855|NCT01399008|FG001|Participant Flow|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
11067856|NCT01399008|FG002|Participant Flow|Placebo|Placebo plus Allopurinol 300 mg
11067857|NCT01399008|OG000|Outcome|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
11067858|NCT01399008|OG001|Outcome|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
11067859|NCT01399008|OG002|Outcome|Placebo|Placebo plus Allopurinol 300 mg
11067860|NCT01399008|EG000|Reported Event|Arhalofenate 400 mg Plus Allopurinol 300 mg|Arhalofenate 400 mg plus allopurinol 300 mg (Safety Population)
11067861|NCT01399008|EG001|Reported Event|Arhalofenate 600 mg Plus Allopurinol 300 mg|Arhalofenate 600 mg plus allopurinol 300 mg (Safety Population)
11067862|NCT01399008|EG002|Reported Event|Placebo Plus Allopurinol 300 mg|Placebo plus allopurinol 300 mg (Safety Population)
11067863|NCT01399047|BG000|Baseline|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
11067864|NCT01399047|BG001|Baseline|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
11067865|NCT01399047|BG002|Baseline|Total|Total of all reporting groups
11067866|NCT01399047|FG000|Participant Flow|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
10887549|NCT00500903|EG001|Reported Event|ECT Dose Escalation|Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).
11067867|NCT01399047|FG001|Participant Flow|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
11067868|NCT01399047|OG000|Outcome|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of treatment order.
11067869|NCT01399047|OG001|Outcome|Placebo|Includes data from all subjects while on placebo, regardless of treatment order.
11067870|NCT01399047|OG000|Outcome|Mycophenolate|All data from subjects while on mycophenolate, regardless of treatment order.
11067871|NCT01399047|OG001|Outcome|Placebo|All data from subjects while on placebo, regardless of treatment order.
11067872|NCT01399047|EG000|Reported Event|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of order.
11067873|NCT01399047|EG001|Reported Event|Placebo|Includes data from all subjects while on placebo, regardless of order.
11067874|NCT01399099|BG000|Baseline|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.
11067875|NCT01399099|FG000|Participant Flow|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.
11067876|NCT01399099|OG000|Outcome|Treated Side|Half of the abdomnioplasty incision was treated with the embrace device.
11067877|NCT01399099|OG001|Outcome|Control Side|Half of the abdomnioplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
11067878|NCT01399099|EG000|Reported Event|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.
11067879|NCT01399125|BG000|Baseline|Rivastigmine Patch|Once-daily target patch size 10 cm²
11067880|NCT01399125|BG001|Baseline|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
11067881|NCT01399125|BG002|Baseline|Total|Total of all reporting groups
11067882|NCT01399125|FG000|Participant Flow|Rivastigmine Patch|Once-daily target patch size 10 cm²
11067883|NCT01399125|FG001|Participant Flow|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
11067884|NCT01399125|OG000|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
11067885|NCT01399125|OG001|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
11067886|NCT01399125|EG000|Reported Event|Rivastigmine Patch|Once-daily target patch size 10 cm²
11067887|NCT01399125|EG001|Reported Event|Rivastigmine Capsule|Twice-daily target dose of 6 mg oral capsule
11067888|NCT01399190|BG000|Baseline|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
11067889|NCT01399190|FG000|Participant Flow|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
11067890|NCT01399190|OG000|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
11067891|NCT01399190|EG000|Reported Event|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
11067892|NCT01399229|BG000|Baseline|Pregnant|The study focused on recruiting laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.
11067893|NCT01399229|FG000|Participant Flow|Pregnant, Preterm, In Labor|Pregnant preterm women independently determined to be in labor.
11067894|NCT01399229|FG001|Participant Flow|Pregnant, Preterm, Non Labor|Pregnant preterm women independently determined to not be in labor.
11067895|NCT01399229|FG002|Participant Flow|Pregnant, Term, Non Labor|Pregnant term women independently determined to be in labor.
11067896|NCT01399229|OG000|Outcome|Pregnant Patents With Uterine Contractions|Patient contractions were monitored with both SureCALL® Labor Monitor® and Tocodynamometer. The times of peak contractions recorded by both devices were compared, and the time differences between contractions were assessed.
11067897|NCT01399229|EG000|Reported Event|Pregnant|
11067898|NCT01399268|BG000|Baseline|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
11067899|NCT01399268|BG001|Baseline|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
11067900|NCT01399268|BG002|Baseline|Total|Total of all reporting groups
11067901|NCT01399268|FG000|Participant Flow|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
11067902|NCT01399268|FG001|Participant Flow|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
11067903|NCT01399268|OG000|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
11067904|NCT01399268|OG001|Outcome|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
11067905|NCT01399268|EG000|Reported Event|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
11067906|NCT01399268|EG001|Reported Event|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
11067907|NCT01399593|BG000|Baseline|Eculizumab|"Patients in the eculizumab treatment group were to receive eculizumab for 9 weeks according to the following dosing regimen:~Eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously."
11067908|NCT01399593|BG001|Baseline|Standard of Care (SOC)|Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
11067909|NCT01399593|BG002|Baseline|Total|Total of all reporting groups
11067910|NCT01399593|FG000|Participant Flow|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9).
11067911|NCT01399593|FG001|Participant Flow|Standard of Care|Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
11067912|NCT01399593|OG000|Outcome|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
11067913|NCT01399593|OG001|Outcome|Standard of Care|Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
11067914|NCT01399593|EG000|Reported Event|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
11067915|NCT01399593|EG001|Reported Event|Standard of Care|Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
11067916|NCT01399619|BG000|Baseline|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067917|NCT01399619|BG001|Baseline|Faldaprevir 240mg -T|patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12.
11067918|NCT01399619|BG002|Baseline|Total|Total of all reporting groups
11067919|NCT01399619|FG000|Participant Flow|Faldaprevir 120mg -24W|Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067920|NCT01399619|FG001|Participant Flow|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067921|NCT01399619|FG002|Participant Flow|Faldaprevir 240mg-24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067922|NCT01399619|FG003|Participant Flow|Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12)|Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.
11067923|NCT01399619|OG000|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067924|NCT01399619|OG001|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067925|NCT01399619|OG002|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue BI 201335 to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067926|NCT01399619|OG003|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
11067927|NCT01399619|OG004|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
11067928|NCT01399619|OG000|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067929|NCT01399619|OG002|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067930|NCT01399619|OG001|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067931|NCT01399619|OG000|Outcome|Faldaprevir 120mg -24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067932|NCT01399619|EG000|Reported Event|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067933|NCT01399619|EG001|Reported Event|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067934|NCT01399619|EG002|Reported Event|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
11067935|NCT01399619|EG003|Reported Event|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
11067936|NCT01399697|BG000|Baseline|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
11067937|NCT01399697|BG001|Baseline|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
11067938|NCT01399697|BG002|Baseline|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
11067939|NCT01399697|BG003|Baseline|Total|Total of all reporting groups
11067940|NCT01399697|FG000|Participant Flow|Tocilizumab (TCZ) Plus (+) Methotrexate (Not Randomized)|Participants received TCZ 8 milligrams per kilogram (mg/kg; maximum 800 mg) via intravenous (IV) infusion every 4 weeks (q4w) through Week 24 (total of 7 infusions). Participants also received methotrexate (MTX) capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
11067941|NCT01399697|FG001|Participant Flow|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
11067942|NCT01399697|FG002|Participant Flow|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
11067943|NCT01399697|OG000|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
11067944|NCT01399697|OG001|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
11067945|NCT01399697|OG000|Outcome|Tocilizumab + Methotrexate (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
11067946|NCT01399697|OG001|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
11067947|NCT01399697|EG000|Reported Event|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
11067948|NCT01399697|EG001|Reported Event|TCZ + MTX (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and MTX in the second part of the study. Response was defined as participants having DAS28 score less than or equal to (<=)3.2.
11067949|NCT01399697|EG002|Reported Event|TCZ + Placebo (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and matching MTX placebo in the second part of the study. Response was defined as participants having DAS28 score <=3.2.
11067950|NCT01399697|EG003|Reported Event|TCZ + MTX (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
11067951|NCT01399697|EG004|Reported Event|TCZ + Placebo (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and matching placebo MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
11067952|NCT01399723|BG000|Baseline|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
11067953|NCT01399723|BG001|Baseline|Penicillin|Benzyl penicillin 50000 IU 6 hourly
11067954|NCT01399723|BG002|Baseline|Total|Total of all reporting groups
11067955|NCT01399723|FG000|Participant Flow|Amoxicillin 45mg/kg 12 Hourly|Amoxicillin: Oral 45mg/kg 12 hourly
11067956|NCT01399723|FG001|Participant Flow|Benzyl Penicillin 50,000IU/kg 6 Hourly|Benzyl penicillin: Intravenous 50,000IU/kg 6 hourly
11067957|NCT01399723|OG000|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
11067958|NCT01399723|OG001|Outcome|Penicillin|Benzyl penicillin 50000 IU/kg 6 hourly
11067959|NCT01399723|OG001|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
11067960|NCT01399723|EG000|Reported Event|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
11067961|NCT01399723|EG001|Reported Event|Benzyl Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
11067962|NCT01399736|BG000|Baseline|FFR-guided Revascularisation Strategy|"In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.~FFR-guided revascularisation strategy: FFR-guided revascularisation strategy"
11067963|NCT01399736|BG001|Baseline|Randomised to Guidelines Group|"In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).~randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina"
11067964|NCT01399736|BG002|Baseline|Total|Total of all reporting groups
11067965|NCT01399736|FG000|Participant Flow|FFR-guided Revascularisation Strategy|"In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.~FFR-guided revascularisation strategy: FFR-guided revascularisation strategy"
11067966|NCT01399736|FG001|Participant Flow|Randomised to Guidelines Group|"In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).~randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina"
11067967|NCT01399736|OG000|Outcome|FFR-guided Revascularisation Strategy|"In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.~FFR-guided revascularisation strategy: FFR-guided revascularisation strategy"
11067968|NCT01399736|OG001|Outcome|Randomised to Guidelines Group|"In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).~randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina"
11067969|NCT01399736|OG000|Outcome|FFR+ and PCI+|patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days
11067970|NCT01399736|OG001|Outcome|FFR+ and PCI-|patients having FFR positive lesions that did not undergo revascularization
11067971|NCT01399736|OG000|Outcome|Acute Treatment FFR+|Patients with acute PCI treatment for lesions with FFR ≤ 0.80
11067972|NCT01399736|OG001|Outcome|Staged Treatement FFR+|Patients with staged PCI treatment for lesions with FFR ≤ 0.80
11067973|NCT01399736|OG000|Outcome|FFR- Lesions Treated With PCI|patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results)
11067974|NCT01399736|OG001|Outcome|FFR- Lesions Treated With Medical Therapy|patients receiving medical therapy for FFR-negative lesions in the non-IRA
11067975|NCT01399736|OG000|Outcome|FFR Guided Complete Revascularisation|Patients who underwent FFR guided complete revascularisation
11067976|NCT01399736|OG001|Outcome|IRA Only Treatment|Patients who underwent IRA only treatment
11067977|NCT01399736|EG000|Reported Event|FFR-guided Revascularisation Strategy|"In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.~FFR-guided revascularisation strategy: FFR-guided revascularisation strategy"
11067978|NCT01399736|EG001|Reported Event|Randomised to Guidelines Group|"In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).~randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina"
11067979|NCT01399788|BG000|Baseline|Entire Study Population|Includes participants randomized to receive Myrin-P Forte first and four single drug references first.
11067980|NCT01399788|FG000|Participant Flow|Myrin-P Forte First, Then Four Single Drug References|Single oral dose of 4 fixed dose combination (FDC) tablets of Myrin-P Forte (each tablet contains 150 milligram (mg) rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in first intervention period; and single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in second intervention period. A washout period of at least 1 week was maintained between each period.
11067981|NCT01399788|FG001|Participant Flow|Four Single Drug References First, Then Myrin-P Forte|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in first intervention period; and single oral dose of 4 FDC tablets of Myrin-P Forte (each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in second intervention period. A washout period of at least 1 week was maintained between each period.
11067982|NCT01399788|OG000|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
11067983|NCT01399788|OG001|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
11233686|NCT02430389|OG000|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
11067984|NCT01399788|EG000|Reported Event|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
11067985|NCT01399788|EG001|Reported Event|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
11067986|NCT01399827|BG000|Baseline|Omega-3 Fatty Acids|"1060 mg EPA Omega-3 Fatty Acids~ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.~Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study."
11067987|NCT01399827|BG001|Baseline|Placebo|ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
11067988|NCT01399827|BG002|Baseline|Total|Total of all reporting groups
11067989|NCT01399827|FG000|Participant Flow|Omega-3 Fatty Acids|"1060 mg EPA Omega-3 Fatty Acids~ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.~Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study."
11067990|NCT01399827|FG001|Participant Flow|Placebo|ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
11091768|NCT01536171|BG000|Baseline|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
11091769|NCT01536171|FG000|Participant Flow|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
11067991|NCT01399827|OG000|Outcome|Omega-3 Fatty Acids|"1060 mg EPA Omega-3 Fatty Acids~ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.~Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study."
11067992|NCT01399827|OG001|Outcome|Placebo|ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
11067993|NCT01399827|EG000|Reported Event|Omega-3 Fatty Acids|"1060 mg EPA Omega-3 Fatty Acids~ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.~Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study."
11067994|NCT01399827|EG001|Reported Event|Placebo|ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
11067995|NCT01399866|BG000|Baseline|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
11067996|NCT01399866|BG001|Baseline|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
11067997|NCT01399866|BG002|Baseline|Total|Total of all reporting groups
11067998|NCT01399866|FG000|Participant Flow|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
11067999|NCT01399866|FG001|Participant Flow|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
11068000|NCT01399866|OG000|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
11068001|NCT01399866|OG001|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
11068002|NCT01399866|EG000|Reported Event|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
11226871|NCT02378714|OG001|Outcome|BASC + Placebo Varenicline|"Behavioral activation for smoking cessation plus placebo varenicline~BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.~Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11068003|NCT01399866|EG001|Reported Event|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
11068004|NCT01399905|BG000|Baseline|Low Carbidopa Followed by High Carbidopa|75 mg of carbidopa per day for four weeks followed by 450 mg of carbidopa per day for four weeks
11068005|NCT01399905|BG001|Baseline|High Carbidopa Followed by Low Carbidopa|450 mg of carbidopa per day for four weeks followed by 75 mg of carbidopa per day for four weeks
11068006|NCT01399905|BG002|Baseline|Total|Total of all reporting groups
11068007|NCT01399905|FG000|Participant Flow|Low Carbidopa Followed by High Carbidopa|75 mg of carbidopa per day for four weeks followed by 450 mg of carbidopa per day for four weeks
11068008|NCT01399905|FG001|Participant Flow|High Carbidopa Followed by Low Carbidopa|450 mg of carbidopa per day for four weeks followed by 75 mg of carbidopa per day for four weeks
11068009|NCT01399905|OG000|Outcome|Low-dose Carbidopa (75 mg/Day) Day 1|Day 1 of levodopa infusions following 4 weeks of low-dose carbidopa (75 mg/day). Carbidopa 25 mg administered at 8 AM, 10 AM and 12 PM for day 1 infusion.
11068010|NCT01399905|OG001|Outcome|Low-dose Carbidopa (75 mg/Day) Day 2|Day 2 of levodopa infusions following 4 weeks of low-dose carbidopa (75 mg/day). Carbidopa 25 mg administered at 8 AM, 10 AM, and 12 PM for day 2 infusion.
11068011|NCT01399905|OG002|Outcome|High-dose Carbidopa (450 mg/Day) Day 1|Day 1 of levodopa infusions following 4 weeks of high-dose carbidopa (450 mg/day). Carbidopa 25 mg administered at 8 AM 10 AM and 12 PM for day 1 infusion.
11068012|NCT01399905|OG003|Outcome|High-dose Carbidopa (450 mg/Day) Day 2|Day 2 of levodopa infusions following 4 weeks of high-dose carbidopa (450 mg/day). Carbidopa 150 mg administered at 8 AM, 10 AM and 12 PM for day 2 levodopa infusion.
11068013|NCT01399905|OG001|Outcome|High-dose Carbidopa (450 mg/Day) Day 1|Day 1 of levodopa infusions following 4 weeks of high-dose carbidopa (450 mg/day). Carbidopa 25 mg administered at 8 AM, 10 AM and 12 PM for day 1 infusion.
11068014|NCT01399905|OG002|Outcome|Low-dose Carbidopa (75 mg/Day) Day 2|Day 2 of levodopa infusions following 4 weeks of low-dose carbidopa (75 mg/day). Carbidopa administered at 8 AM, 10 AM and 12 PM for day 2 infusion.
11068015|NCT01399905|OG003|Outcome|High-dose Carbidopa (450 mg/Day) Day 2|Day 2 of levodopa infusions following 4 weeks of high-dose carbidopa (450 mg/day). Carbidopa 150 mg administered at 8 AM, 10 AM and 12 PM on day 2.
11068016|NCT01399905|EG000|Reported Event|Low-dose Carbidopa (75 mg/Day)|Due to the cross-over study design all 12 participants who completed the study are included in both the high-dose and low-dose treatment arms.
11335659|NCT03554629|OG004|Outcome|EtCO2 During Mouth Open Breathing Rate of 6|Patient interface to sample gas for end tidal CO2 (EtCO2) capnography measurement under condition of open mouth breathing and respiration rate of 6 with supplemental O2 at 5lpm.
11068017|NCT01399905|EG001|Reported Event|High-dose Carbidopa (450 mg/Day)|Due to the cross-over study design all 12 participants who completed the study are included in both the high-dose and low-dose treatment arms. In addition, the subject who initiated treatment but did not complete the study is included in this arm for the purpose of reporting adverse events.
11068018|NCT01400113|BG000|Baseline|Asenapine|60 patients were randomized to this group
11068019|NCT01400113|BG001|Baseline|Placebo|60 patients were randomized to this group
11068020|NCT01400113|BG002|Baseline|Total|Total of all reporting groups
11068021|NCT01400113|FG000|Participant Flow|Asenapine|60 patients were randomized to this group
11068022|NCT01400113|FG001|Participant Flow|Placebo|60 patients were randomized to this group
11068023|NCT01400113|OG000|Outcome|Asenapine|60 patients were randomized to this group
11068024|NCT01400113|OG001|Outcome|Placebo|60 patients were randomized to this group
11068025|NCT01400113|EG000|Reported Event|Asenapine|Asenapine: Asenapine Sublingual Tablet 10mg, single-dose
11068026|NCT01400113|EG001|Reported Event|Placebo|Placebo: Placebo Sublingual Tablet, single-dose
11068027|NCT01400139|BG000|Baseline|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11068028|NCT01400139|FG000|Participant Flow|Hydrocodone Bitartrate (HYD)|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11068029|NCT01400139|OG000|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11068030|NCT01400139|OG001|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11068031|NCT01400139|EG000|Reported Event|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11068032|NCT01400139|EG001|Reported Event|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11068033|NCT01400243|BG000|Baseline|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
11068034|NCT01400243|BG001|Baseline|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
11068035|NCT01400243|BG002|Baseline|Total|Total of all reporting groups
11068036|NCT01400243|FG000|Participant Flow|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
11068037|NCT01400243|FG001|Participant Flow|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
11068038|NCT01400243|OG000|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
11068039|NCT01400243|OG001|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
11068040|NCT01400243|OG000|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
11068041|NCT01400243|OG001|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
11068042|NCT01400243|EG000|Reported Event|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
11068043|NCT01400243|EG001|Reported Event|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
11068044|NCT01400412|BG000|Baseline|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
11068045|NCT01400412|BG001|Baseline|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
11068046|NCT01400412|BG002|Baseline|Total|Total of all reporting groups
11068047|NCT01400412|FG000|Participant Flow|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
11091770|NCT01536171|OG000|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
11091771|NCT01536171|OG000|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|two running conditions, with normal running shoes and barefoot
11091772|NCT01536171|EG000|Reported Event|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
11068048|NCT01400412|FG001|Participant Flow|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
11068049|NCT01400412|OG000|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
11068050|NCT01400412|OG001|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
11068051|NCT01400412|OG000|Outcome|MVC Arm: DRV/r + MVC + FTC + TDF Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.~Maraviroc: Maraviroc was administered orally once a day as one 150 mg tablet."
11068052|NCT01400412|OG001|Outcome|TDF Arm: DRV/r + TDF + FTC + MVC Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one tablet."
11068053|NCT01400412|EG000|Reported Event|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
11068054|NCT01400412|EG001|Reported Event|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
11091773|NCT01536184|BG000|Baseline|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
11091774|NCT01536184|BG001|Baseline|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
11091775|NCT01536184|BG002|Baseline|Total|Total of all reporting groups
11173494|NCT02015819|FG003|Participant Flow|Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. They will also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11068055|NCT01400425|BG000|Baseline|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
11068056|NCT01400425|FG000|Participant Flow|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
11068057|NCT01400425|OG000|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
11068058|NCT01400425|OG001|Outcome|Subjectss With a Positive Scan|Subjects with progressive cognitive decline that received a positive florbetapir scan.
11068059|NCT01400425|OG002|Outcome|Subjects With a Negative Scan|Subjects with progressive cognitive decline that received a negative scan.
11068060|NCT01400425|EG000|Reported Event|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
11068061|NCT01400451|BG000|Baseline|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1, plus 960 mg vemurafenib orally twice daily throughout combination treatment."
11068062|NCT01400451|BG001|Baseline|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
11068063|NCT01400451|BG002|Baseline|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
11068064|NCT01400451|BG003|Baseline|Total|Total of all reporting groups
11068065|NCT01400451|FG000|Participant Flow|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily throughout combination treatment."
11068066|NCT01400451|FG001|Participant Flow|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
11068067|NCT01400451|FG002|Participant Flow|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily. Note: the dose of vemurafenib could be escalated from 720 mg to 960 mg, at the investigator's discretion.
11068068|NCT01400451|OG000|Outcome|960 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
11068069|NCT01400451|OG001|Outcome|720 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
11068070|NCT01400451|OG002|Outcome|720 mg Vemurafenib Alone|"These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.~Events from first day of vemurafenib to last day of treatment + 90 days, up to date of data cut off for Primary Endpoint."
11068071|NCT01400451|OG000|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
11068072|NCT01400451|OG001|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
11068073|NCT01400451|OG000|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily continuing during combination treatment.
11068074|NCT01400451|EG000|Reported Event|Lead-In Period 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
11068075|NCT01400451|EG001|Reported Event|Lead-In Period 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
11068076|NCT01400451|EG002|Reported Event|Lead- In Period 720 mg Vemurafenib Alone|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
11068077|NCT01400451|EG003|Reported Event|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
11068078|NCT01400451|EG004|Reported Event|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
11068079|NCT01400477|BG000|Baseline|DMXB-A-SR|"Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)~DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)"
11068080|NCT01400477|BG001|Baseline|Arm #2: Placebo Comparator|"Inert capsule to resemble active drug.~Placebo: Placebo Comparator"
11068081|NCT01400477|BG002|Baseline|Total|Total of all reporting groups
11068082|NCT01400477|FG000|Participant Flow|DMXB-A-SR|"Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)~DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)"
11068083|NCT01400477|FG001|Participant Flow|Arm #2: Placebo Comparator|"Inert capsule to resemble active drug.~Placebo: Placebo Comparator"
11068084|NCT01400477|OG000|Outcome|DMXB-A-SR|"Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)~DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)"
11068085|NCT01400477|OG001|Outcome|Arm #2: Placebo Comparator|"Inert capsule to resemble active drug.~Placebo: Placebo Comparator"
11068086|NCT01400477|EG000|Reported Event|DMXB-A-SR|"Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)~DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)"
11068087|NCT01400477|EG001|Reported Event|Arm #2: Placebo Comparator|"Inert capsule to resemble active drug.~Placebo: Placebo Comparator"
11068088|NCT01400503|BG000|Baseline|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
11068089|NCT01400503|FG000|Participant Flow|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
11068090|NCT01400503|OG000|Outcome|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
11068091|NCT01400503|EG000|Reported Event|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
11068092|NCT01400516|BG000|Baseline|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
11068093|NCT01400516|BG001|Baseline|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
11068094|NCT01400516|BG002|Baseline|Total|Total of all reporting groups
11068095|NCT01400516|FG000|Participant Flow|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
11068096|NCT01400516|FG001|Participant Flow|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
11068097|NCT01400516|OG000|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
11068098|NCT01400516|OG001|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
11068099|NCT01400516|EG000|Reported Event|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
11068100|NCT01400516|EG001|Reported Event|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
11068101|NCT01400698|BG000|Baseline|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068102|NCT01400698|BG001|Baseline|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068103|NCT01400698|BG002|Baseline|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068104|NCT01400698|BG003|Baseline|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068105|NCT01400698|BG004|Baseline|Total|Total of all reporting groups
11068106|NCT01400698|FG000|Participant Flow|Saizen® Continuous (A1)|Participants with bone age less than or equal to (<=) 12 years for girls or 14 years for boys and height <=-2 standard deviation (SD) received continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc) until they reached final height for a maximum duration of 10.6 years.
11068107|NCT01400698|FG001|Participant Flow|Saizen® Intermittent (A2)|Participants with bone age <=12 years for girls or 14 years for boys and height <=-2 SD received intermittent treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Intermittent treatment was given on an individual basis depending on the height achieved during the study.
11068108|NCT01400698|FG002|Participant Flow|Observed, Not Randomized (B0)|Participants with bone age <=12 years for girls or 14 years for boys and height greater than (>) -2 SD were observed until first signs of puberty but not randomized.
11068109|NCT01400698|FG003|Participant Flow|Observed Then Randomized to Saizen® (B1)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to receive continuous treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
11068110|NCT01400698|FG004|Participant Flow|Observed Then Randomized to Observation (B2)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to observation group with no treatment until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
11068111|NCT01400698|FG005|Participant Flow|Observation (C)|Participants with bone age >12 years for girls or 14 years for boys or refused to be treated in any of the above groups were followed without treatment until they reached final height for a maximum duration of 10.6 years.
11068112|NCT01400698|OG000|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068113|NCT01400698|OG001|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068114|NCT01400698|OG002|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068115|NCT01400698|OG003|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068116|NCT01400698|OG000|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068117|NCT01400698|OG001|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068118|NCT01400698|EG000|Reported Event|Not Treated|Included all participants who did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068119|NCT01400698|EG001|Reported Event|Treated|Included all participants who received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
11068120|NCT01400815|BG000|Baseline|X-22 Smoking Cessation Product|"The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.~X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
11068121|NCT01400815|BG001|Baseline|Active Control Cigarette|"The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.~Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
11068122|NCT01400815|BG002|Baseline|Total|Total of all reporting groups
11068123|NCT01400815|FG000|Participant Flow|X-22 Smoking Cessation Product|"The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.~X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
11173495|NCT02015819|OG000|Outcome|Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11068124|NCT01400815|FG001|Participant Flow|Active Control Cigarette|"The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.~Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
11068125|NCT01400815|OG000|Outcome|X-22 Smoking Cessation Product|"The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.~X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
11068126|NCT01400815|OG001|Outcome|Active Control Cigarette|"The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.~Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
11068127|NCT01400815|EG000|Reported Event|X-22 Smoking Cessation Product|"The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.~X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
11068128|NCT01400815|EG001|Reported Event|Active Control Cigarette|"The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.~Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
11068129|NCT01400841|BG000|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
11068130|NCT01400841|FG000|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
11068131|NCT01400841|OG000|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
11068132|NCT01400841|EG000|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
11068133|NCT01400880|BG000|Baseline|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
11068134|NCT01400880|FG000|Participant Flow|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, TOCO and IUPC
11068135|NCT01400880|OG000|Outcome|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation studied with electrode sensor, Tocodynamometer and IUPC
11068136|NCT01400880|EG000|Reported Event|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
11068137|NCT01400893|BG000|Baseline|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
11068138|NCT01400893|BG001|Baseline|CRRT Alone|Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
11068139|NCT01400893|BG002|Baseline|Total|Total of all reporting groups
11068140|NCT01400893|FG000|Participant Flow|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
11068141|NCT01400893|FG001|Participant Flow|CRRT Alone|Patients with a diagnosis of acute kidney injury and multiorgan failure requiring CRRT will be randomized
11068142|NCT01400893|OG000|Outcome|CRRT + SCD|"Patients with a diagnosis of AKI requires CRRT will be randomized~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
11068143|NCT01400893|OG001|Outcome|CRRT Alone|Patients with a diagnosis of AKI requires CRRT will be randomized
11173496|NCT02015819|OG001|Outcome|Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11173497|NCT02015819|OG002|Outcome|Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11068144|NCT01400893|OG000|Outcome|CRRT + SCD|"Patients with a diagnosis of AKI will be randomized~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
11068145|NCT01400893|OG001|Outcome|CRRT Alone|Patients with a diagnosis of AKI will be randomized
11068146|NCT01400893|EG000|Reported Event|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
11068147|NCT01400893|EG001|Reported Event|CRRT Alone|Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
11068148|NCT01400906|BG000|Baseline|Placebo, FP 100 µg, and FP 500 µg in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods, one inhalation in the morning and evening from Day 1 to 6 and one inhalation on the morning on Day 7, from the Dry Powder Inhaler (DPI): Placebo; Fluticasone propionate (FP) 100 micrograms (µg); and FP 500 µg. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FP 100 µg, FP 500 µg; (2) Placebo, FP 500 µg, FP 100 µg; (3) FP 100 µg, Placebo, FP 500 µg; (4) FP 100 µg, FP 500 µg, Placebo; (5) FP 500 µg, Placebo, FP 100 µg; (6) FP 500 µg, FP 100 µg, Placebo. The three treatment periods were separated by a washout period of 14 days.
11068149|NCT01400906|FG000|Participant Flow|Sequence 1: Placebo, FP 100 µg, FP 500 µg|Participants received placebo, Fluticasone Propionate (FP) 100 micrograms (µg), and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 14 days.
11068150|NCT01400906|FG001|Participant Flow|Sequence 2: Placebo, FP 500 µg, FP 100 µg|Participants received Placebo, FP 500 µg, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
11068151|NCT01400906|FG002|Participant Flow|Sequence 3: FP 100 µg, Placebo, FP 500 µg|Participants received FP 100 µg, Placebo, and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
11068152|NCT01400906|FG003|Participant Flow|Sequence 4: FP 100 µg, FP 500 µg, Placebo|Participants received FP 100 µg, FP 500 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
11068153|NCT01400906|FG004|Participant Flow|Sequence 5: FP 500 µg, Placebo, FP 100 µg|Participants received FP 500 µg, Placebo, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
11068154|NCT01400906|FG005|Participant Flow|Sequence 6: FP 500 µg, FP 100 µg, Placebo|Participants received FP 500 µg, FP 100 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
11068155|NCT01400906|OG000|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
11068156|NCT01400906|OG001|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
11068157|NCT01400906|OG002|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
11068158|NCT01400906|EG000|Reported Event|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
11068159|NCT01400906|EG001|Reported Event|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
11068160|NCT01400906|EG002|Reported Event|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
11068161|NCT01400919|BG000|Baseline|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
11068162|NCT01400919|FG000|Participant Flow|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
11068163|NCT01400919|OG000|Outcome|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
11068164|NCT01400919|EG000|Reported Event|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
11068165|NCT01400932|BG000|Baseline|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
11068166|NCT01400932|BG001|Baseline|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
11068167|NCT01400932|BG002|Baseline|Total|Total of all reporting groups
11068168|NCT01400932|FG000|Participant Flow|GI148512|Participants applied 2 finger tip units (FTU) of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
11068169|NCT01400932|FG001|Participant Flow|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
11068170|NCT01400932|OG000|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
11068171|NCT01400932|OG001|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
11068172|NCT01400932|EG000|Reported Event|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
11068173|NCT01400932|EG001|Reported Event|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
11068174|NCT01400958|BG000|Baseline|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
11068175|NCT01400958|BG001|Baseline|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
11068176|NCT01400958|BG002|Baseline|Total|Total of all reporting groups
11068177|NCT01400958|FG000|Participant Flow|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
11068178|NCT01400958|FG001|Participant Flow|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
11068179|NCT01400958|OG000|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
11068180|NCT01400958|OG001|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
11068181|NCT01400958|EG000|Reported Event|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
11068182|NCT01400958|EG001|Reported Event|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
11068183|NCT01400971|BG000|Baseline|MOSAIc Participants|Participants enrolled in MOSAIc who had complete treatment data during the study.
11068184|NCT01400971|FG000|Participant Flow|MOSAIc Participants|Participants enrolled in Multinational Observational Study Assessing Insulin use (MOSAIc) who had complete treatment data during the study.
11068185|NCT01400971|OG000|Outcome|MOSAIc Participants|Participants enrolled in MOSAIc who had complete treatment data during the study.
11068186|NCT01400971|EG000|Reported Event|MOSAIc Participants|Participants enrolled in MOSAIc who had complete treatment data during the study.
11068187|NCT01401010|BG000|Baseline|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
11068188|NCT01401010|BG001|Baseline|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
11068189|NCT01401010|BG002|Baseline|Total|Total of all reporting groups
11068190|NCT01401010|FG000|Participant Flow|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
11068191|NCT01401010|FG001|Participant Flow|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
11068192|NCT01401010|OG000|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
11068193|NCT01401010|OG001|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
11068194|NCT01401010|OG002|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
11068195|NCT01401010|OG000|Outcome|500 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
11068196|NCT01401010|OG001|Outcome|500 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
11068197|NCT01401010|OG002|Outcome|1000 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
11068198|NCT01401010|OG003|Outcome|1000 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
11068199|NCT01401010|EG000|Reported Event|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
11068200|NCT01401010|EG001|Reported Event|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
11068201|NCT01401023|BG000|Baseline|CDAD Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
11068202|NCT01401023|FG000|Participant Flow|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
11068203|NCT01401023|OG000|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tigecycline: : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
11068204|NCT01401023|OG000|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
11068205|NCT01401023|OG000|Outcome|Clostridium Difficile Patient|Open non comparative trial
11068206|NCT01401023|EG000|Reported Event|CDAD Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
11068207|NCT01401062|BG000|Baseline|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
11068208|NCT01401062|BG001|Baseline|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
11068209|NCT01401062|BG002|Baseline|Total|Total of all reporting groups
11068210|NCT01401062|FG000|Participant Flow|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
11068211|NCT01401062|FG001|Participant Flow|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
11068212|NCT01401062|OG000|Outcome|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
11068213|NCT01401062|OG001|Outcome|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
11068214|NCT01401062|EG000|Reported Event|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
11068215|NCT01401062|EG001|Reported Event|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
11068216|NCT01401101|BG000|Baseline|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
11068217|NCT01401101|BG001|Baseline|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
11068218|NCT01401101|BG002|Baseline|Total|Total of all reporting groups
11068219|NCT01401101|FG000|Participant Flow|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
11068220|NCT01401101|FG001|Participant Flow|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
11068221|NCT01401101|OG000|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
11068222|NCT01401101|OG001|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
11068223|NCT01401101|EG000|Reported Event|PTSD Care Management (PCM)|There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
11068224|NCT01401101|EG001|Reported Event|Treatment-as-Usual (TAU)|The TAU condition consists of only the clinician education and patient screening without written feedback.
11068225|NCT01401153|BG000|Baseline|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
11068226|NCT01401153|BG001|Baseline|Skipping Lunch|No lunch (water)
11068227|NCT01401153|BG002|Baseline|Total|Total of all reporting groups
11068228|NCT01401153|FG000|Participant Flow|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
11068229|NCT01401153|FG001|Participant Flow|Skipping Lunch|No lunch (water)
11068230|NCT01401153|OG000|Outcome|Having Lunch|Lunch ad libitum
11068231|NCT01401153|OG001|Outcome|Skipping Lunch|No lunch (water)
11068232|NCT01401153|OG001|Outcome|Skipping Lunch|No lunch (water) o
11068233|NCT01401153|EG000|Reported Event|Having Lunch|Lunch ad libitum
11068234|NCT01401153|EG001|Reported Event|Skipping Lunch|No lunch (water)
11173498|NCT02015819|OG003|Outcome|Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg + Leucovorin + Microdialysis|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11068235|NCT01401166|BG000|Baseline|Cohort 1 Overall: SC (SID) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
11068236|NCT01401166|BG001|Baseline|Cohort 2 Overall: SC (Vial) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
11068237|NCT01401166|BG002|Baseline|Total|Total of all reporting groups
11068238|NCT01401166|FG000|Participant Flow|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.
11068239|NCT01401166|FG001|Participant Flow|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
11068240|NCT01401166|FG002|Participant Flow|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
11068241|NCT01401166|FG003|Participant Flow|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
11068242|NCT01401166|OG000|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
11068243|NCT01401166|OG001|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
11068244|NCT01401166|OG002|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
11068245|NCT01401166|OG003|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
11068246|NCT01401166|OG000|Outcome|All HCPs: SC and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
11068247|NCT01401166|EG000|Reported Event|Cohort 1: SC (SID) Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via SID as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
11068248|NCT01401166|EG001|Reported Event|Cohort 1: IV Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
11068249|NCT01401166|EG002|Reported Event|Cohort 1: IV Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received IV Herceptin as a 6-mg/kg dose for up to 10 remaining cycles. Administration was performed by HCP.
11068250|NCT01401166|EG003|Reported Event|Cohort 1: SC (SID) Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID as a 600-mg dose under the direction of a trained HCP.
11068251|NCT01401166|EG004|Reported Event|Cohort 1 Overall: SC (SID) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
11068252|NCT01401166|EG005|Reported Event|Cohort 2: SC (Vial) Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via handheld syringe using the vial formulation as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
11068253|NCT01401166|EG006|Reported Event|Cohort 2: IV Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
11068254|NCT01401166|EG007|Reported Event|Cohort 2: IV Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants were planned to receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. However, under protocol deviation a small number of participants received IV Herceptin as a 6-mg/kg dose for this period. Administration was performed by HCP.
11068255|NCT01401166|EG008|Reported Event|Cohort 2: SC (Vial) Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP.
11068256|NCT01401166|EG009|Reported Event|Cohort 2 Overall: SC (Vial) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
11068257|NCT01401257|BG000|Baseline|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068258|NCT01401257|BG001|Baseline|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068259|NCT01401257|BG002|Baseline|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068260|NCT01401257|BG003|Baseline|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
11068261|NCT01401257|BG004|Baseline|Total|Total of all reporting groups
11068262|NCT01401257|FG000|Participant Flow|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068263|NCT01401257|FG001|Participant Flow|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068264|NCT01401257|FG002|Participant Flow|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068265|NCT01401257|FG003|Participant Flow|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
11068266|NCT01401257|OG000|Outcome|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068267|NCT01401257|OG001|Outcome|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068268|NCT01401257|OG002|Outcome|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068269|NCT01401257|OG003|Outcome|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
11068270|NCT01401257|EG000|Reported Event|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068271|NCT01401257|EG001|Reported Event|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068272|NCT01401257|EG002|Reported Event|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
11068273|NCT01401257|EG003|Reported Event|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
11068274|NCT01401283|BG000|Baseline|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
11068275|NCT01401283|BG001|Baseline|Control Group|hemodynamic management according to institutional clinical standards
11068276|NCT01401283|BG002|Baseline|Total|Total of all reporting groups
11068277|NCT01401283|FG000|Participant Flow|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
11068278|NCT01401283|FG001|Participant Flow|Control Group|hemodynamic management according to institutional clinical standards
11068279|NCT01401283|OG000|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
11068280|NCT01401283|OG001|Outcome|Control Group|hemodynamic management according to institutional clinical standards
11068281|NCT01401283|EG000|Reported Event|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
11068282|NCT01401283|EG001|Reported Event|Control Group|hemodynamic management according to institutional clinical standards
11068283|NCT01401322|BG000|Baseline|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
11068284|NCT01401322|FG000|Participant Flow|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
11068285|NCT01401322|OG000|Outcome|Lenalidomide 50 mg/Day x 28 Days|"Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.~Lenalidomide: 50 mg; po"
11068286|NCT01401322|EG000|Reported Event|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
11068287|NCT01401361|BG000|Baseline|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
11068288|NCT01401361|FG000|Participant Flow|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
11068289|NCT01401361|OG000|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
11068290|NCT01401361|EG000|Reported Event|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
11068291|NCT01401452|BG000|Baseline|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
11068292|NCT01401452|FG000|Participant Flow|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
11068293|NCT01401452|OG000|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
11068294|NCT01401452|EG000|Reported Event|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
11068295|NCT01401465|BG000|Baseline|Sequence CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
11068296|NCT01401465|BG001|Baseline|Sequence MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
11068297|NCT01401465|BG002|Baseline|Total|Total of all reporting groups
11068298|NCT01401465|FG000|Participant Flow|CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
11068299|NCT01401465|FG001|Participant Flow|MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
11068300|NCT01401465|OG000|Outcome|Ciclesonide Versus Mometasone|This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide
11068301|NCT01401465|OG000|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
11068302|NCT01401465|OG001|Outcome|Mometasone|Mometasone AQ 200 mcg
11068303|NCT01401465|OG000|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
11068304|NCT01401465|OG001|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
11068305|NCT01401465|EG000|Reported Event|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
11068306|NCT01401465|EG001|Reported Event|Mometasone|Mometasone AQ 200 mcg
11068307|NCT01401478|BG000|Baseline|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
11068308|NCT01401478|FG000|Participant Flow|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
11068309|NCT01401478|OG000|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
11068310|NCT01401478|EG000|Reported Event|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
11068311|NCT01401517|BG000|Baseline|Placebo|Placebo twice each day for 11 weeks
11068312|NCT01401517|BG001|Baseline|40 mg Sodium Nitrite|"40 mg dose, BID~40 mg sodium nitrite: 40 twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
11068313|NCT01401517|BG002|Baseline|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
11068314|NCT01401517|BG003|Baseline|Total|Total of all reporting groups
11068315|NCT01401517|FG000|Participant Flow|Placebo|sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.
11068316|NCT01401517|FG001|Participant Flow|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
11068317|NCT01401517|FG002|Participant Flow|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
11068318|NCT01401517|OG000|Outcome|Placebo|0 mg twice each day for 11 weeks.
11068319|NCT01401517|OG001|Outcome|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
11068320|NCT01401517|OG002|Outcome|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite:80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
11068321|NCT01401517|EG000|Reported Event|Placebo|sodium nitrite: 0 mg twice each day for 11 weeks .
11068322|NCT01401517|EG001|Reported Event|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
11068323|NCT01401517|EG002|Reported Event|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
11068324|NCT01401530|BG000|Baseline|Cohort 1: 6 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068325|NCT01401530|BG001|Baseline|Cohort 2: 9 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068326|NCT01401530|BG002|Baseline|Cohort 3: 12 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068327|NCT01401530|BG003|Baseline|Total|Total of all reporting groups
11068328|NCT01401530|FG000|Participant Flow|Cohort 1: 6 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068329|NCT01401530|FG001|Participant Flow|Cohort 2: 9 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068330|NCT01401530|FG002|Participant Flow|Cohort 3: 12 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068331|NCT01401530|OG000|Outcome|Denileukin Diftitox|Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068332|NCT01401530|OG000|Outcome|Cohort 1: 6 ug/kg/Day Denileukin Diftitox|Denileukin diftitox (6 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068333|NCT01401530|OG001|Outcome|Cohort 2: 9 ug/kg/Day Denileukin Diftitox|Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068334|NCT01401530|OG002|Outcome|Cohort 3: 12 ug/kg/Day Denileukin Diftitox|Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068335|NCT01401530|OG000|Outcome|Denileukin Diftitox|Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068336|NCT01401530|EG000|Reported Event|Cohort 1: 6 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068337|NCT01401530|EG001|Reported Event|Cohort 2: 9 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068338|NCT01401530|EG002|Reported Event|Cohort 3: 12 ug/kg/Day Denileukin Diftitox|Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
11068339|NCT01401543|BG000|Baseline|Entire Study Population|All randomized participants
11068340|NCT01401543|FG000|Participant Flow|Sequence 1|"First intervention: A 5-milligram (mg) LY2452473 capsule and 5-mg tadalafil tablet administered orally, once.~Second intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) administered orally, once.~Third intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) administered orally, once.~Fourth intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) administered orally, once.~There was a washout period of at least 7 days between each intervention. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value."
11068341|NCT01401543|FG001|Participant Flow|Sequence 2|"First intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) administered orally, once.~Second intervention: A 5-mg LY2452473 capsule and 5-mg tadalafil tablet administered orally, once.~Third intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) administered orally, once.~Fourth intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) administered orally, once.~There was a washout period of at least 7 days between each intervention. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value."
11068342|NCT01401543|FG002|Participant Flow|Sequence 3|"First intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) administered orally, once.~Second intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) administered orally, once.~Third intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 =40 microns, and 5 mg tadalafil) administered orally, once.~Fourth intervention: A 5-mg LY2452473 capsule and 5-mg tadalafil tablet administered orally, once.~There was a washout period of at least 7 days between each intervention. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value."
11068343|NCT01401543|FG003|Participant Flow|Sequence 4|"First intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) administered orally, once.~Second intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) administered orally, once.~Third intervention: A 5-mg LY2452473 capsule and 5-mg tadalafil tablet administered orally, once.~Fourth intervention: A single combination tablet LY900010 (5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) administered orally, once.~There was a washout period of at least 7 days between each intervention. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value."
11068344|NCT01401543|OG000|Outcome|5 mg LY2452473 and 5 mg Tadalafil|Participants who were administered a 5-milligram (mg) LY2452473 capsule and 5-mg tadalafil tablet during any study period.
11068345|NCT01401543|OG001|Outcome|LY900010 (Particle Size #1)|Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) during any study period.
11068346|NCT01401543|OG002|Outcome|LY900010 (Particle Size #2)|Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) during any study period.
11068347|NCT01401543|OG003|Outcome|LY900010 (Particle Size #3)|Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) during any study period.
11068348|NCT01401543|OG002|Outcome|LY900010 (Particle Size #2)|Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size# 2, d90 = 25 microns, and 5 mg tadalafil) during any study period.
11068349|NCT01401543|OG001|Outcome|LY900010 (Particle Size #1)|Participants who were administered a single combination tablet LY900010 (5 mg LY2452473 with a smaller particle size #1, d90 = 10 micron, and 5 mg tadalafil) during any study period.
11068350|NCT01401543|OG002|Outcome|LY900010 (Particle Size #2)|Participants who were administered a single combination tablet LY900010 (5 mg LY2452473 with an intermediate particle size #2, d90 = 25 micron, and 5 mg tadalafil) during any study period.
11068351|NCT01401543|OG003|Outcome|LY900010 (Particle Size #3)|Participants who were administered a single combination tablet LY900010 (5 mg LY2452473 with a larger particle size #3, d90 = 40 micron, and 5 mg tadalafil) during any study period.
11068352|NCT01401543|EG000|Reported Event|5 mg LY2452473 and 5 mg Tadalafil|Participants who were administered a 5-mg LY2452473 capsule and 5-mg tadalafil tablet during any study period.
11068353|NCT01401543|EG001|Reported Event|LY900010 (Particle Size #1)|Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) during any study period.
11068354|NCT01401543|EG002|Reported Event|LY900010 (Particle Size #2)|Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) during any study period.
11068355|NCT01401543|EG003|Reported Event|LY900010 (Particle Size #3)|Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) during any study period.
11068356|NCT01401582|BG000|Baseline|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
11068357|NCT01401582|BG001|Baseline|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
11068358|NCT01401582|BG002|Baseline|Total|Total of all reporting groups
11068359|NCT01401582|FG000|Participant Flow|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
11068360|NCT01401582|FG001|Participant Flow|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
11068361|NCT01401582|OG000|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
11068362|NCT01401582|OG001|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Implementation of Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
11068363|NCT01401582|OG001|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
11068364|NCT01401582|OG000|Outcome|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
11068365|NCT01401582|OG001|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
11068366|NCT01401582|EG000|Reported Event|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
11068367|NCT01401582|EG001|Reported Event|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
11068368|NCT01401595|BG000|Baseline|Night Eaters|31 participants screened and diagnosed with NES attended the baseline treatment session and at least one follow-up appointment.
11068369|NCT01401595|BG001|Baseline|Control Subjects|10 control participants completed the baseline screening and SPECT scans.
11068370|NCT01401595|BG002|Baseline|Total|Total of all reporting groups
11150230|NCT01876485|BG000|Baseline|Arm 1: Empowering Patients in Chronic Care (EPIC)|"Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.~Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans."
11068371|NCT01401595|FG000|Participant Flow|Night Eaters|"Subjects were given a medical history, and height and weight was measured. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test was also administered no more than 48 hours before SPECT-CT imaging and the beginning of Lexapro treatment. Lexapro treatment lasted 12 weeks.~escitalopram oxalate: The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding in 30 night eaters with that of 10 controls. The first procedure assessed SPECT-CT images of night eaters and controls. Medication was administered starting at 10 mg daily, with increases up to 20 mg, as indicated and tolerated, for up to three months. Visits occured at baseline and weeks 1, 2, 4, 6, 8, 10, and 12."
11068372|NCT01401595|FG001|Participant Flow|Control Subjects|"At the beginning of the study, control subjects were given a medical history, height and weight was measured, and BMI calculated. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing.~An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding of the 10 control subjects with that of the 30 night eating subjects to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls."
11068373|NCT01401595|OG000|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All subjects with NES participated in the open label treatment with escitalopram, although of the 32 participants, 1 did not return after her initial medication visit. As it is unknown if this participants started the medication, only the 31 participants who returned to a second visit or more were included in the analysis
11068374|NCT01401595|OG001|Outcome|Controls|The control participants did not participate in the treatment part of the study - only the baseline SPECT scans.
11068375|NCT01401595|OG000|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All NES subjects received the open label escitalopram treatment
11068376|NCT01401595|OG001|Outcome|Controls|The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
11068377|NCT01401595|EG000|Reported Event|Night Eating Syndrome Open Label Treatment Group|Only the 32 participants with NES participated in the open label escitalopram treatment trial. One participant did not return after the first visit, and it is unknown if she ever started the medication. Thus 31 participants were included in the statistical analyses.
11068378|NCT01401647|BG000|Baseline|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
11068379|NCT01401647|BG001|Baseline|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
11068380|NCT01401647|BG002|Baseline|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
11068381|NCT01401647|BG003|Baseline|Total|Total of all reporting groups
11068382|NCT01401647|FG000|Participant Flow|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
11068383|NCT01401647|FG001|Participant Flow|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
11068384|NCT01401647|FG002|Participant Flow|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
11068385|NCT01401647|OG000|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
11068386|NCT01401647|OG001|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
11068387|NCT01401647|OG002|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
11068388|NCT01401647|EG000|Reported Event|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
11068389|NCT01401647|EG001|Reported Event|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
11068390|NCT01401647|EG002|Reported Event|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
11068391|NCT01401699|BG000|Baseline|Optical Frequency Domain Imaging System|"OFDI imaging~Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus"
11068392|NCT01401699|FG000|Participant Flow|Optical Frequency Domain Imaging System|"OFDI imaging~Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus"
11068393|NCT01401699|OG000|Outcome|Optical Frequency Domain Imaging|Optical Frequency Domain imaging data
11068394|NCT01401699|EG000|Reported Event|Optical Frequency Domain Imaging System|"OFDI imaging~Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus"
11068395|NCT01401842|BG000|Baseline|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
11068396|NCT01401842|BG001|Baseline|Stabilization Exercise|Low intensity core stabilization exercise
11068397|NCT01401842|BG002|Baseline|Total|Total of all reporting groups
11068398|NCT01401842|FG000|Participant Flow|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
11068399|NCT01401842|FG001|Participant Flow|Stabilization Exercise|Low intensity core stabilization exercise
11068400|NCT01401842|OG000|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
11068401|NCT01401842|OG001|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
11068402|NCT01401842|EG000|Reported Event|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
11068403|NCT01401842|EG001|Reported Event|Stabilization Exercise|Low intensity core stabilization exercise
11068404|NCT01401907|BG000|Baseline|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
11068405|NCT01401907|BG001|Baseline|Standard of Care|Subjects receives standard of care
11068406|NCT01401907|BG002|Baseline|Total|Total of all reporting groups
11068407|NCT01401907|FG000|Participant Flow|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
11068408|NCT01401907|FG001|Participant Flow|Standard of Care|Subjects receives standard of care
11068409|NCT01401907|OG000|Outcome|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
11068410|NCT01401907|OG001|Outcome|Standard of Care|Subjects receives standard of care
11068411|NCT01401907|OG000|Outcome|Early Palliative Care|
11068412|NCT01401907|OG001|Outcome|Standard Oncology Care|
11068413|NCT01401907|EG000|Reported Event|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
11068414|NCT01401907|EG001|Reported Event|Standard of Care|Subjects receives standard of care
11068415|NCT01401959|BG000|Baseline|Cohort A: Triple-negative Breast Cancer Patients|Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068416|NCT01401959|BG001|Baseline|Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients|Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068417|NCT01401959|BG002|Baseline|Cohort C: HER2-positive Breast Cancer Patients|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
11068418|NCT01401959|BG003|Baseline|Total|Total of all reporting groups
11068419|NCT01401959|FG000|Participant Flow|Cohort A: Triple-negative Breast Cancer Patients|Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068420|NCT01401959|FG001|Participant Flow|Cohort B: ER/PR Positive/HER2-negative Breast Cancer|Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068421|NCT01401959|FG002|Participant Flow|Cohort C: HER2-positive Breast Cancer Patients|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
11068422|NCT01401959|OG000|Outcome|Cohort A: Triple-negative Breast Cancer Patients|Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068423|NCT01401959|OG001|Outcome|Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients|Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068424|NCT01401959|OG002|Outcome|Cohort C: HER2-positive Breast Cancer Patients|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
11068425|NCT01401959|OG000|Outcome|Cohort A: Triple-negative Breast Cancer Patients|Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068426|NCT01401959|OG001|Outcome|Cohort B: ER/PR Positive/HER2-negative Breast Cancer|Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068427|NCT01401959|EG000|Reported Event|Cohort A: Triple-negative Breast Cancer|Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068428|NCT01401959|EG001|Reported Event|Cohort B: ER/PR Positive/HER2-negative Breast Cancer|Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
11068429|NCT01401959|EG002|Reported Event|Cohort C: HER2 Positive Breast Cancer|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
11068430|NCT01402011|BG000|Baseline|25% Dextrose in Ligaments and Tendons|"25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons.~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068431|NCT01402011|BG001|Baseline|.1% Lidocaine in Ligaments and Tendons|".1% lidocaine injected in the shoulder ligaments and tendons~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068432|NCT01402011|BG002|Baseline|.1% Lidocaine Subcutaneous|".1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder.~shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula."
11357466|NCT03757234|OG003|Outcome|Omadacycline 200 iv/450 po or 100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
11068433|NCT01402011|BG003|Baseline|Total|Total of all reporting groups
11068434|NCT01402011|FG000|Participant Flow|25% Dextrose in Ligaments and Tendons|"25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons.~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068435|NCT01402011|FG001|Participant Flow|.1% Lidocaine in Ligaments and Tendons|".1% lidocaine injected in the shoulder ligaments and tendons~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068436|NCT01402011|FG002|Participant Flow|.1% Lidocaine Subcutaneous|".1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder.~shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula."
11068437|NCT01402011|OG000|Outcome|25% Dextrose in Shoulder Entheses|"25% dextrose and .1% lidocaine injected in the shoulder entheses (ligament and tendon insertions on the periosteum).~25% dextrose in shoulder entheses: injections of 1 mL of 25% dextrose and .1% lidocaine solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068438|NCT01402011|OG001|Outcome|.1% Lidocaine in Shoulder Entheses|".1% lidocaine injected in the shoulder entheses (ligament and tendon insertions on the periosteum).~.1% lidocaine in shoulder entheses: injections of 1 mL of .1% lidocaine 'ssolution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068439|NCT01402011|OG002|Outcome|.1% Lidocaine Subcu. Above Shouldr Enth.|".1% lidocaine injected subcutaneously above the shoulder entheses (ligament and tendon insertions on the periosteum).~.1% lidocaine subcu. above shouldr enth.: injections of 1 mL of .1% lidocaine solution subcutaneously, above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic, above the insertion of the teres minor and the triceps on the scapula."
11068440|NCT01402011|OG000|Outcome|25% Dextrose in Ligaments and Tendons|"25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons.~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068441|NCT01402011|OG001|Outcome|.1% Lidocaine in Ligaments and Tendons|".1% lidocaine injected in the shoulder ligaments and tendons~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068442|NCT01402011|OG002|Outcome|.1% Lidocaine Subcutaneous|".1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder.~shoulder injections: injections of 1 mL of solution subcutaneously above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic above the insertion of the teres minor and the triceps on the scapula."
11068443|NCT01402011|EG000|Reported Event|25% Dextrose in Ligaments and Tendons|"25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons.~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068444|NCT01402011|EG001|Reported Event|.1% Lidocaine in Ligaments and Tendons|".1% lidocaine injected in the shoulder ligaments and tendons~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068445|NCT01402011|EG002|Reported Event|.1% Lidocaine Subcutaneous|".1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder.~shoulder injections: injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula."
11068446|NCT01402050|BG000|Baseline|FOLEY BALLOON|"Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery~FOLEY BALLOON: INDUCTION OF LABOR"
11068447|NCT01402050|BG001|Baseline|CERVIDIL|CERVIDIL (Dinoprostone): INDUCTION OF LABOR
11068448|NCT01402050|BG002|Baseline|Total|Total of all reporting groups
11068449|NCT01402050|FG000|Participant Flow|FOLEY BALLOON|"Comparing Foley balloon to Cervidil for decreased time from the start of the induction process to delivery is the aim of this RCT.~Subjects randomized into the Foley Balloon Arm received a Foley Balloon past the cervical os filled with 30 cc of sterile water, and catheter taped to inside of maternal thigh. Catheter was removed for any of the 5 reasons: expulsion, nonreasurring fetal heart rate tracing mandating placement of internal monitors, tachysystole, spontaneous membrane rupture, or 12 hours elapsed since placement.~Key words: FOLEY BALLOON: INDUCTION OF LABOR"
11173499|NCT02015819|OG000|Outcome|Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11068450|NCT01402050|FG001|Participant Flow|CERVIDIL|"CERVIDIL (Dinoprostone) Arm: Subjects randomized to this arm received dinoprostone controlled release vaginal insert (standard dosing Cervidil, 0.3mg/hour of dinoprostone over 12 hours). The vaginal insert was placed in the posterior fornix and was removed for any of the 5 reasons stated for the Foley catheter Arm description. Fetal heart rate and uterine contractions were continuously monitored per standard. Time of placement was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction.~Key word: INDUCTION OF LABOR"
11068451|NCT01402050|OG000|Outcome|FOLEY BALLOON|"Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery~FOLEY BALLOON: INDUCTION OF LABOR"
11068452|NCT01402050|OG001|Outcome|CERVIDIL|CERVIDIL (Dinoprostone): INDUCTION OF LABOR
11068453|NCT01402050|EG000|Reported Event|FOLEY BALLOON|"Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery~FOLEY BALLOON: INDUCTION OF LABOR"
11068454|NCT01402050|EG001|Reported Event|CERVIDIL|CERVIDIL (Dinoprostone): INDUCTION OF LABOR
11068455|NCT01402063|BG000|Baseline|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
11068456|NCT01402063|BG001|Baseline|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
11068457|NCT01402063|BG002|Baseline|Total|Total of all reporting groups
11068458|NCT01402063|FG000|Participant Flow|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
11068459|NCT01402063|FG001|Participant Flow|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
11068460|NCT01402063|OG000|Outcome|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
11068461|NCT01402063|OG001|Outcome|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
11068462|NCT01402063|EG000|Reported Event|Radiation Plus PPX and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
11068463|NCT01402063|EG001|Reported Event|Radiation + Temozolomide and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
11068464|NCT01402102|BG000|Baseline|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
11068465|NCT01402102|BG001|Baseline|Placebo|Oral intake placebo(6.0g/day) for 12weeks
11068466|NCT01402102|BG002|Baseline|Total|Total of all reporting groups
11068467|NCT01402102|FG000|Participant Flow|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
11068468|NCT01402102|FG001|Participant Flow|Placebo|Oral intake placebo(6.0g/day) for 12weeks
11068469|NCT01402102|OG000|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
11068470|NCT01402102|OG001|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
11068471|NCT01402102|OG000|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
11068472|NCT01402102|OG001|Outcome|Placebo|Placebo 6.0g/day oral intake
11068473|NCT01402102|EG000|Reported Event|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
11068474|NCT01402102|EG001|Reported Event|Placebo|Oral intake placebo(6.0g/day) for 12weeks
11068475|NCT01402115|BG000|Baseline|Polycan|Polycan 150mg for 12 weeks
11068476|NCT01402115|BG001|Baseline|Placebo|Placebo 15mg for 12 weeks
11068477|NCT01402115|BG002|Baseline|Total|Total of all reporting groups
11068478|NCT01402115|FG000|Participant Flow|Polycan|Polycan 150mg for 12 weeks
11068479|NCT01402115|FG001|Participant Flow|Placebo|Placebo 15mg for 12 weeks
11068480|NCT01402115|OG000|Outcome|Polycan|Polycan 150mg for 12 weeks
11068481|NCT01402115|OG001|Outcome|Placebo|Placebo 15mg for 12 weeks
11068482|NCT01402115|EG000|Reported Event|Polycan|Polycan 150mg for 12 weeks
11068483|NCT01402115|EG001|Reported Event|Placebo|Placebo 15mg for 12 weeks
11068484|NCT01402128|BG000|Baseline|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
11068485|NCT01402128|BG001|Baseline|Placebo|Placebo for 12 weeks
11068486|NCT01402128|BG002|Baseline|Total|Total of all reporting groups
11068487|NCT01402128|FG000|Participant Flow|Barley Beta-glucan|"Barley beta-glucan(1times/day, 1packs/day, 3g/day) for 12weeks~Barley beta-glucan: Barley as raw material is milled by crushing the liquefaction and saccharification enzymes reacted after baking yeast (S. cereviasiae) for 48 h, is produced through the fermentation process."
11068488|NCT01402128|FG001|Participant Flow|Placebo|"Placebo(1times/day, 1packs/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Barley beta-glucan"
11068489|NCT01402128|OG000|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
11068490|NCT01402128|OG001|Outcome|Placebo|Placebo for 12 weeks
11068491|NCT01402128|EG000|Reported Event|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
11068492|NCT01402128|EG001|Reported Event|Placebo|Placebo for 12 weeks
11068493|NCT01402141|BG000|Baseline|Chungkookjang(35g)|
11068494|NCT01402141|BG001|Baseline|Placebo(35g)|
11068495|NCT01402141|BG002|Baseline|Total|Total of all reporting groups
11068496|NCT01402141|FG000|Participant Flow|Chungkookjang|"Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks~Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying"
11068497|NCT01402141|FG001|Participant Flow|Placebo|"Placebo(3times/day, 3packs/day, 35g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Chungkookjang."
11068498|NCT01402141|OG000|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
11068499|NCT01402141|OG001|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
11068500|NCT01402141|OG001|Outcome|Placeb|Oral intake placebo(35g/day) for 12weeks
11068501|NCT01402141|EG000|Reported Event|Chungkookjang(35g)|Oral intake Chungkookjang(35g) for 12weeks.
11068502|NCT01402141|EG001|Reported Event|Placebo(35g)|Oral intake placebo(35g/day) for 12weeks
11068503|NCT01402284|BG000|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
11068504|NCT01402284|FG000|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone Therapy|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
11068505|NCT01402284|OG000|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
11068506|NCT01402284|EG000|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
11068507|NCT01402375|BG000|Baseline|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
11068508|NCT01402375|BG001|Baseline|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
11068509|NCT01402375|BG002|Baseline|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
11226872|NCT02378714|OG002|Outcome|Standard Treatment + Active Varenicline|"Standard behavioral smoking cessation treatment plus active varenicline~Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.~Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11226873|NCT02378714|OG003|Outcome|BASC + Active Varenicline|"Behavioral activation for smoking cessation plus active varenicline~Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.~BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.~Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
11226874|NCT02378714|OG000|Outcome|Placebo - Week 1|"Placebo group during first week of treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226875|NCT02378714|OG001|Outcome|Varenicline - Week 1|"Varenicline group during first week of treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226876|NCT02378714|OG002|Outcome|Placebo - Week 6|"Placebo group mid-treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226877|NCT02378714|OG003|Outcome|Varenicline - Week 6|"Placebo group mid-treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226878|NCT02378714|OG004|Outcome|Placebo - Week 14|"Placebo group at end of treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226879|NCT02378714|OG005|Outcome|Varenicline - Week 14|"Placebo group at end of treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226880|NCT02378714|EG000|Reported Event|Placebo - Week 1|"Placebo group during first week of treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226881|NCT02378714|EG001|Reported Event|Varenicline - Week 1|"Varenicline group during first week of treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226882|NCT02378714|EG002|Reported Event|Placebo - Week 3|"Placebo group at week 3.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226883|NCT02378714|EG003|Reported Event|Varenicline - Week 3|"Varenicline group at week 3.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226884|NCT02378714|EG004|Reported Event|Placebo - Week 4|"Placebo group at week 4.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226885|NCT02378714|EG005|Reported Event|Varenicline - Week 4|"Varenicline group at week 4.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226886|NCT02378714|EG006|Reported Event|Placebo - Week 6|"Placebo group mid-treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226887|NCT02378714|EG007|Reported Event|Varenicline - Week 6|"Varenicline group mid-treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11335660|NCT03554629|OG005|Outcome|FiCO2 During Mouth Open Breathing Rate of 6|Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of open mouth breathing and respiration rate of 6 with supplemental O2 at 5lpm.
11068510|NCT01402375|BG003|Baseline|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
11068511|NCT01402375|BG004|Baseline|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
11068512|NCT01402375|BG005|Baseline|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
11068513|NCT01402375|BG006|Baseline|Total|Total of all reporting groups
11068514|NCT01402375|FG000|Participant Flow|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
11068515|NCT01402375|FG001|Participant Flow|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
11068516|NCT01402375|FG002|Participant Flow|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
11068517|NCT01402375|FG003|Participant Flow|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
11068518|NCT01402375|FG004|Participant Flow|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
11068519|NCT01402375|FG005|Participant Flow|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
11068520|NCT01402375|OG000|Outcome|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
11068521|NCT01402375|OG001|Outcome|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
11068522|NCT01402375|OG002|Outcome|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
11068523|NCT01402375|OG003|Outcome|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
11068524|NCT01402375|OG004|Outcome|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
11068525|NCT01402375|OG005|Outcome|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
11068526|NCT01402375|EG000|Reported Event|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
11068527|NCT01402375|EG001|Reported Event|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
11068528|NCT01402375|EG002|Reported Event|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
11068529|NCT01402375|EG003|Reported Event|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
11068530|NCT01402375|EG004|Reported Event|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
11068531|NCT01402375|EG005|Reported Event|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
11068532|NCT01402427|BG000|Baseline|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
11068533|NCT01402427|BG001|Baseline|Placebo|Placebo: Intraarterial administration of 10 mL saline.
11068534|NCT01402427|BG002|Baseline|Total|Total of all reporting groups
11068535|NCT01402427|FG000|Participant Flow|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
11068536|NCT01402427|FG001|Participant Flow|Placebo|Placebo: Intraarterial administration of 10 mL saline.
11068537|NCT01402427|OG000|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
11068538|NCT01402427|OG001|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
11226888|NCT02378714|EG008|Reported Event|Placebo - Week 7|"Placebo group at week 7.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226889|NCT02378714|EG009|Reported Event|Varenicline - Week 7|"Varenicline group at week 7.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226890|NCT02378714|EG010|Reported Event|Placebo - Week 8|"Placebo group at week 8.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226891|NCT02378714|EG011|Reported Event|Varenicline - Week 8|"Varenicline group at week 8.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226892|NCT02378714|EG012|Reported Event|Placebo - Week 10|"Placebo group at week 10.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226893|NCT02378714|EG013|Reported Event|Varenicline - Week 10|"Varenicline group at week 10.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226894|NCT02378714|EG014|Reported Event|Placebo - Week 12|"Placebo group at week 12.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226895|NCT02378714|EG015|Reported Event|Varenicline - Week 12|"Varenicline group at week 12.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226896|NCT02378714|EG016|Reported Event|Placebo - Week 14|"Placebo group at end of treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226897|NCT02378714|EG017|Reported Event|Varenicline - Week 14|"Varenicline group at end of treatment.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226898|NCT02378714|EG018|Reported Event|Placebo - Week 27|"Placebo group at week 27.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226899|NCT02378714|EG019|Reported Event|Varenicline - Week 27|"Varenicline group at week 27.~Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally~Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment."
11226900|NCT02378753|BG000|Baseline|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
11226901|NCT02378753|BG001|Baseline|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18-24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
11226902|NCT02378753|BG002|Baseline|Total|Total of all reporting groups
11226903|NCT02378753|FG000|Participant Flow|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
11226904|NCT02378753|FG001|Participant Flow|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18-24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
11226905|NCT02378753|OG000|Outcome|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
11226906|NCT02378753|OG001|Outcome|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18-24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
11226907|NCT02378753|EG000|Reported Event|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
11226908|NCT02378753|EG001|Reported Event|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18-24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
11226909|NCT02378844|BG000|Baseline|gammaCore®-R|"Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).~gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side)."
11226910|NCT02378844|BG001|Baseline|gammaCore®-R Sham|"Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).~gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side)."
11226911|NCT02378844|BG002|Baseline|Total|Total of all reporting groups
11226912|NCT02378844|FG000|Participant Flow|gammaCore®-R|"Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).~gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side)."
11226913|NCT02378844|FG001|Participant Flow|gammaCore®-R Sham|"Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).~gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side)."
11226914|NCT02378844|FG002|Participant Flow|Not Randomized|Subjects that were screen failures and were not randomized
11226915|NCT02378844|OG000|Outcome|gammaCore®-R|"Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).~gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side)."
10887550|NCT00500903|EG002|Reported Event|Relative Bioavailability|Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).
11068539|NCT01402427|EG000|Reported Event|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
11068540|NCT01402427|EG001|Reported Event|Placebo|Placebo: Intraarterial administration of 10 mL saline.
11068541|NCT01402492|BG000|Baseline|BUP4+XR-NTX|4mg buprenorphine plus naltrexone for 8 weeks of treatment
11068542|NCT01402492|BG001|Baseline|BUP16+XR-NTX|16mg buprenorphine plus naltrexone for 8 weeks of treatment
11068543|NCT01402492|BG002|Baseline|PLB+XR-NTX|Placebo plus naltrexone for 8 weeks of treatment
10887551|NCT00501007|BG000|Baseline|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
11068544|NCT01402492|BG003|Baseline|Total|Total of all reporting groups
11068545|NCT01402492|FG000|Participant Flow|BUP4+XR-NTX|4mg buprenorphine plus naltrexone for 8 weeks of treatment
11068546|NCT01402492|FG001|Participant Flow|BUP16+XR-NTX|16mg buprenorphine plus naltrexone for 8 weeks of treatment
11068547|NCT01402492|FG002|Participant Flow|PLB+XR-NTX|Placebo plus naltrexone for 8 weeks of treatment
11068548|NCT01402492|OG000|Outcome|BUP4+XR-NTX|4mg buprenorphine plus naltrexone for 8 weeks of treatment
11068549|NCT01402492|OG001|Outcome|BUP16+XR-NTX|16mg buprenorphine plus naltrexone for 8 weeks of treatment
11068550|NCT01402492|OG002|Outcome|PLB+XR-NTX|Placebo plus naltrexone for 8 weeks of treatment
11068551|NCT01402492|EG000|Reported Event|BUP4+XR-NTX|4mg buprenorphine plus naltrexone for 8 weeks of treatment
11068552|NCT01402492|EG001|Reported Event|BUP16+XR-NTX|16mg buprenorphine plus naltrexone for 8 weeks of treatment
11068553|NCT01402492|EG002|Reported Event|PLB+XR-NTX|Placebo plus naltrexone for 8 weeks of treatment
11068554|NCT01402544|BG000|Baseline|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year~ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline."
11068555|NCT01402544|FG000|Participant Flow|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year~ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline."
11068556|NCT01402544|OG000|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year~ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline."
11068557|NCT01402544|EG000|Reported Event|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year~ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline."
11068558|NCT01402570|BG000|Baseline|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
11068559|NCT01402570|FG000|Participant Flow|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
11068560|NCT01402570|OG000|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
11068561|NCT01402570|OG000|Outcome|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
11068562|NCT01402570|EG000|Reported Event|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
11068563|NCT01402700|BG000|Baseline|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
11068564|NCT01402700|FG000|Participant Flow|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
11068565|NCT01402700|OG000|Outcome|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
11068566|NCT01402700|EG000|Reported Event|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
11068567|NCT01402817|BG000|Baseline|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
11068568|NCT01402817|FG000|Participant Flow|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
11068569|NCT01402817|OG000|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.
11068570|NCT01402817|OG000|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
11068571|NCT01402817|EG000|Reported Event|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
11068572|NCT01402869|BG000|Baseline|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
11068573|NCT01402869|BG001|Baseline|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
11068574|NCT01402869|BG002|Baseline|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
11068575|NCT01402869|BG003|Baseline|Total|Total of all reporting groups
11335661|NCT03554629|OG006|Outcome|EtCO2 Mouth Open Breathing Rate of 24|Patient interface to sample gas for capnography measurement under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm.
11068576|NCT01402869|FG000|Participant Flow|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
11068577|NCT01402869|FG001|Participant Flow|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
11068578|NCT01402869|FG002|Participant Flow|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
11068579|NCT01402869|OG000|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
11068580|NCT01402869|OG001|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
11068581|NCT01402869|OG002|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
11068582|NCT01402869|EG000|Reported Event|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
11068583|NCT01402869|EG001|Reported Event|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
11068584|NCT01402869|EG002|Reported Event|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
11068585|NCT01402947|BG000|Baseline|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
11068586|NCT01402947|BG001|Baseline|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
11233687|NCT02430389|OG001|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Normal Saline: Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
10887552|NCT00501007|FG000|Participant Flow|Non-psychiatric Smokers|Smokers without a diagnosis of schizophrenia or schizoaffective disorder
10887553|NCT00501007|FG001|Participant Flow|Smokers With Schizophrenia / Schizoaffective Disorder|Smokers meeting criteria for schizophrenia or schizoaffective disorder
11068587|NCT01402947|BG002|Baseline|Total|Total of all reporting groups
11068588|NCT01402947|FG000|Participant Flow|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
11068589|NCT01402947|FG001|Participant Flow|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
11068590|NCT01402947|OG000|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
11068591|NCT01402947|OG001|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
11068592|NCT01402947|EG000|Reported Event|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
11068593|NCT01402947|EG001|Reported Event|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
11068594|NCT01402986|BG000|Baseline|Placebo, Q2W - Cohort 1|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
11068595|NCT01402986|BG001|Baseline|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
11068596|NCT01402986|BG002|Baseline|Placebo, Q2/4W - Cohort 2|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068597|NCT01402986|BG003|Baseline|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068598|NCT01402986|BG004|Baseline|Total|Total of all reporting groups
11068599|NCT01402986|FG000|Participant Flow|Placebo, Q2W - Cohort 1|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
11068600|NCT01402986|FG001|Participant Flow|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
11068601|NCT01402986|FG002|Participant Flow|Placebo, Q2/4W - Cohort 2|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068602|NCT01402986|FG003|Participant Flow|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068603|NCT01402986|OG000|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068604|NCT01402986|OG001|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
11068605|NCT01402986|OG002|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068606|NCT01402986|OG000|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
11068607|NCT01402986|OG001|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068608|NCT01402986|EG000|Reported Event|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068609|NCT01402986|EG001|Reported Event|Tralokinumab 300 mg Q2W|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
11068610|NCT01402986|EG002|Reported Event|Tralokinumab 300 mg Q2/4W|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
11068611|NCT01403051|BG000|Baseline|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11068612|NCT01403051|BG001|Baseline|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11068613|NCT01403051|BG002|Baseline|Total|Total of all reporting groups
11335662|NCT03554629|OG007|Outcome|FiCO2 Mouth Open Breathing Rate of 24|Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm.
11068614|NCT01403051|FG000|Participant Flow|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11068615|NCT01403051|FG001|Participant Flow|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11068616|NCT01403051|OG000|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11068617|NCT01403051|OG001|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11173500|NCT02015819|OG001|Outcome|Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11335663|NCT03554629|OG000|Outcome|20 Second No Breath Alarm With Actual Respiration Rate of 24|"When actual respiration rate was 24 breaths per minute~CO2 derived RR from the gas sample provide by the CO2 Cannula Sampling Filterline (CCSF)"
11335664|NCT03554629|OG001|Outcome|30 Second No Breath Alarm With Actual Respiration Rate of 24|"When actual respiration rate was 24.~CO2 derived RR from the gas sample provide by the CO2 Cannula Sampling Filterline (CCSF)"
11068618|NCT01403051|OG001|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11068619|NCT01403051|EG000|Reported Event|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11068620|NCT01403051|EG001|Reported Event|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
11068621|NCT01403064|BG000|Baseline|Placebo|0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
11068622|NCT01403064|BG001|Baseline|ALD518 (160 mg, OL)|ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment
11068623|NCT01403064|BG002|Baseline|ALD518 (160 mg, R)|ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068624|NCT01403064|BG003|Baseline|ALD518 (320 mg, R)|ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068625|NCT01403064|BG004|Baseline|Total|Total of all reporting groups
11068626|NCT01403064|FG000|Participant Flow|Placebo|0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
11068627|NCT01403064|FG001|Participant Flow|ALD518 (160 mg, OL)|ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment
11068628|NCT01403064|FG002|Participant Flow|ALD518 (160 mg, R)|ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068629|NCT01403064|FG003|Participant Flow|ALD518 (320 mg, R)|ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068630|NCT01403064|OG000|Outcome|Placebo|0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
11068631|NCT01403064|OG001|Outcome|ALD518 (160 mg)|ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068632|NCT01403064|OG002|Outcome|ALD518 (320 mg)|ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068633|NCT01403064|OG001|Outcome|ALD518 (160 mg, OL)|ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment
11068634|NCT01403064|OG002|Outcome|ALD518 (160 mg, R)|ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068635|NCT01403064|OG003|Outcome|ALD518 (320 mg, R)|ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068636|NCT01403064|OG000|Outcome|ALD518 (160 mg, OL)|ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment
11068637|NCT01403064|OG001|Outcome|ALD518 (160 mg, R)|ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
10887554|NCT00501007|OG000|Outcome|Schizophrenia or Schizoaffective Disorder|Smokers meeting Diagnostic and Statistical Manual criteria for Schizophrenia or Schizoaffective Disorder
11068638|NCT01403064|OG002|Outcome|ALD518 (320 mg, R)|ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068639|NCT01403064|OG001|Outcome|ALD518 (160 mg)|ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment and ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068640|NCT01403064|EG000|Reported Event|Placebo|0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
11068641|NCT01403064|EG001|Reported Event|ALD518 (160 mg)|ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068642|NCT01403064|EG002|Reported Event|ALD518 (320 mg)|ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
11068643|NCT01403090|BG000|Baseline|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
11068644|NCT01403090|FG000|Participant Flow|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
11068645|NCT01403090|OG000|Outcome|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
11068646|NCT01403090|EG000|Reported Event|Angel Catheter|
11068647|NCT01403116|BG000|Baseline|Oral Testosterone Undecanoate (TU)|"Treatment Period 1: 100 mg capsules, BID, with food~Treatment Period 2: One of the following dosages:~100 mg BID~150 mg BID~100 mg BID~100 mg and 150 mg BID~150 mg capsules BID~Safety Follow-up Phase:~Initial dose: ~84 doses Maintenance dose-Titrated dose: ~96 doses Safety follow-up at maintenance dose: ~540 doses~Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60."
11068648|NCT01403116|BG001|Baseline|Topical Testosterone Gel|"Treatment Period 1: 5 g of 1% transdermal T-gel applied QD~Treatment Period 2:~2.5 g of 1% transdermal T-gel applied QD~5 g of 1% transdermal T-gel applied QD~7.5 g of 1% transdermal T-gel applied QD~10 g of 1% transdermal T-gel applied QD~Safety Follow-up Phase:~Initial dose: ~42 doses Maintenance dose-Titrated dose: ~48 doses Safety follow-up at maintenance dose: ~270 doses~topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60."
11068649|NCT01403116|BG002|Baseline|Total|Total of all reporting groups
11068650|NCT01403116|FG000|Participant Flow|Oral Testosterone Undecanoate (TU)|"Treatment Period 1: 100 mg capsules, BID, with food~Treatment Period 2: One of the following dosages:~100 mg BID~150 mg BID~100 mg BID~100 mg and 150 mg BID~150 mg capsules BID~Safety Follow-up Phase:~Initial dose: ~84 doses Maintenance dose-Titrated dose: ~96 doses Safety follow-up at maintenance dose: ~540 doses~Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60."
11068651|NCT01403116|FG001|Participant Flow|Topical Testosterone Gel|"Treatment Period 1: 5 g of 1% transdermal T-gel applied QD~Treatment Period 2:~2.5 g of 1% transdermal T-gel applied QD~5 g of 1% transdermal T-gel applied QD~7.5 g of 1% transdermal T-gel applied QD~10 g of 1% transdermal T-gel applied QD~Safety Follow-up Phase:~Initial dose: ~42 doses Maintenance dose-Titrated dose: ~48 doses Safety follow-up at maintenance dose: ~270 doses~topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60."
11068652|NCT01403116|OG000|Outcome|Oral Testosterone Undecanoate (TU)|"Treatment Period 1: 100 mg capsules, BID, with food~Treatment Period 2: One of the following dosages:~100 mg BID~150 mg BID~100 mg BID~100 mg and 150 mg BID~150 mg capsules BID~Safety Follow-up Phase:~Initial dose: ~84 doses Maintenance dose-Titrated dose: ~96 doses Safety follow-up at maintenance dose: ~540 doses~Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60."
11068653|NCT01403116|OG001|Outcome|Topical Testosterone Gel|"Treatment Period 1: 5 g of 1% transdermal T-gel applied QD~Treatment Period 2:~2.5 g of 1% transdermal T-gel applied QD~5 g of 1% transdermal T-gel applied QD~7.5 g of 1% transdermal T-gel applied QD~10 g of 1% transdermal T-gel applied QD~Safety Follow-up Phase:~Initial dose: ~42 doses Maintenance dose-Titrated dose: ~48 doses Safety follow-up at maintenance dose: ~270 doses~topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60."
11068654|NCT01403116|EG000|Reported Event|Oral Testosterone Undecanoate (TU)|"Treatment Period 1: 100 mg capsules, BID, with food~Treatment Period 2: One of the following dosages:~100 mg BID~150 mg BID~100 mg BID~100 mg and 150 mg BID~150 mg capsules BID~Safety Follow-up Phase:~Initial dose: ~84 doses Maintenance dose-Titrated dose: ~96 doses Safety follow-up at maintenance dose: ~540 doses~Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60."
11068655|NCT01403116|EG001|Reported Event|Topical Testosterone Gel|"Treatment Period 1: 5 g of 1% transdermal T-gel applied QD~Treatment Period 2:~2.5 g of 1% transdermal T-gel applied QD~5 g of 1% transdermal T-gel applied QD~7.5 g of 1% transdermal T-gel applied QD~10 g of 1% transdermal T-gel applied QD~Safety Follow-up Phase:~Initial dose: ~42 doses Maintenance dose-Titrated dose: ~48 doses Safety follow-up at maintenance dose: ~270 doses~topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60."
11068656|NCT01403246|BG000|Baseline|Study Group|
11068657|NCT01403246|FG000|Participant Flow|Lenalidomide and Chlorambucil|
11068658|NCT01403246|OG000|Outcome|Study Group|
11068659|NCT01403246|EG000|Reported Event|Study Group|
11068660|NCT01403376|BG000|Baseline|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
11068661|NCT01403376|BG001|Baseline|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
11068662|NCT01403376|BG002|Baseline|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
11068663|NCT01403376|BG003|Baseline|Total|Total of all reporting groups
11068664|NCT01403376|FG000|Participant Flow|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
11068665|NCT01403376|FG001|Participant Flow|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
11068666|NCT01403376|FG002|Participant Flow|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
11068667|NCT01403376|OG000|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
11068668|NCT01403376|OG001|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
11068669|NCT01403376|OG002|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
11068670|NCT01403376|EG000|Reported Event|Teriflunomide 7mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
11068671|NCT01403376|EG001|Reported Event|Teriflunomide 14mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
11068672|NCT01403376|EG002|Reported Event|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
11068673|NCT01403441|BG000|Baseline|Open Treatment Study|Open treatment with Cyberknife System targeting brain area cingulate 25.
11068674|NCT01403441|FG000|Participant Flow|Open Treatment Study|All three subjects had Cyberknife treatment targeting the subgenual cingulate cortex, and then followed for 12 months observation and assessments of depression severity.
11068675|NCT01403441|OG000|Outcome|Radiosurgical Neuromodulation|"Bilateral Radiosurgical Neuromodulation using the Cyberknife~Radiosurgical Neuromodulation using the Cyberknife: our team has selected 60 Gy as the dose to the target margin to be used for radiosurgical neuromodulation in patients with intractable bipolar disorder; the target being the anterior cingulate that correlates with Brodmann area 25 (Cg25)."
11068676|NCT01403441|OG000|Outcome|Open Treatment Study|All three subjects had Cyberknife treatment, and then followed for 12 months observation and assessments.
11068677|NCT01403441|OG000|Outcome|Open Treatment Study|Subjects had precision targeted radiotherapy using the Cyberknife System that targeted the subgenual cingulate cortex (approximating Brodmann area 25), and then had assessments of depression severity at intervals for 12 months.
11068678|NCT01403441|EG000|Reported Event|Radiosurgical Neuromodulation|"Precision stereotactic radiotherapy targeted the subgenual cingulate cortex (which approximates Brodmann area cingulate 25) using 60 Gy as the dose to the target margin using the CyberKnife System.~Subject 3 had a signal abnormality on the MRI of the brain at 9 month time point which was unchanged 12 months on both T1 and T2 acquisition images. This is one adverse event that was sustained. The presence of the signal abnormality at 9 and 12 months indicates it did not change. A change in this type of signal abnormality would not be expected to resolve on that time scale. This adverse event is one occurrence that sustained for the next 3 months."
11068679|NCT01403584|BG000|Baseline|All Participants|"Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure~AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation."
11068680|NCT01403584|FG000|Participant Flow|AutoVPAP With Addition of AutoEPAP|"First AutoVPAP With addition of AutoEPAP then AutoVPAP with EPAP Manually Selected~Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure~AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation."
11068681|NCT01403584|FG001|Participant Flow|AutoVPAP With EPAP Manually Selected|"First AutoVPAP With EPAP Manually Selected then AutoVPAP With Addition of AutoEPAP.~A period of treatment using conventionally applied Expiratory Positive Airway Pressure~AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation."
11068682|NCT01403584|OG000|Outcome|Automatic Algorithm - AutoVPAP With Addition of AutoEPAP|"Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure~AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation."
10887555|NCT00501007|OG001|Outcome|Non-psychiatric Group|Smokers NOT meeting criteria for schizophrenia, schizophrenia, bipolar disorder.
11068683|NCT01403584|OG001|Outcome|Conventional Therapy - AutoVPAP With EPAP Manually Selected|"A period of treatment using conventionally applied Expiratory Positive Airway Pressure~AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation."
11068684|NCT01403584|EG000|Reported Event|Automatic Algorithm - AutoVPAP With Addition of AutoEPAP|"Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure~AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter"
11068685|NCT01403584|EG001|Reported Event|Conventional Therapy - AutoVPAP With EPAP Manually Selected|"A period of treatment using conventionally applied Expiratory Positive Airway Pressure~AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter"
11068686|NCT01403610|BG000|Baseline|Cohort 1|Prior to surgery subjects will be assigned to this group in a 2:1 randomization, ie. 2 subjects will be assigned to TH-302 and one to placebo. A single dose of 575 mg/m2 or placebo will be administered pre-operatively with hypoxyprobe-1 at 500 mg/m2 over 20 minutes. Subjects in this group receive TH-302 at a dose of 240mg/m2 post surgery.
11068687|NCT01403610|BG001|Baseline|Cohort 2|Subjects received 340mg/m2 of TH-302 post surgery
11068688|NCT01403610|BG002|Baseline|Cohort 3|Subjects were dosed with 480mg/m2 of TH-302 regardless of whether or not surgery was performed. 3 subjects in this arm had surgery prior to this dose of TH-302.
11068689|NCT01403610|BG003|Baseline|Cohort 4|Subjects in this cohort did not undergo any surgery, a dose of 670mg/m2 was administered to all.
11068690|NCT01403610|BG004|Baseline|Total|Total of all reporting groups
11068691|NCT01403610|FG000|Participant Flow|Cohort 1|Prior to surgery subjects will be assigned to this group in a 2:1 randomization, ie. 2 subjects will be assigned to TH-302 and one to placebo. A single dose of 575 mg/m2 or placebo will be administered pre-operatively with hypoxyprobe-1 at 500 mg/m2 over 20 minutes. Subjects in this group receive TH-302 at a dose of 240mg/m2 post surgery.
10887556|NCT00501007|OG000|Outcome|Smoking Cessation|Participants received tobacco dependence treatment
10887557|NCT00501007|EG000|Reported Event|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
11068692|NCT01403610|FG001|Participant Flow|Cohort 2|Subjects received 340mg/m2 of TH-302 post surgery
11068693|NCT01403610|FG002|Participant Flow|Cohort 3|Subjects were dosed with 480mg/m2 of TH-302 regardless of whether or not surgery was performed. 3 subjects in this arm had surgery prior to this dose of TH-302.
11068694|NCT01403610|FG003|Participant Flow|Cohort 4|Subjects in this cohort did not undergo any surgery, a dose of 670mg/m2 was administered to all.
11068695|NCT01403610|OG000|Outcome|Cohort 1|Bevacizumab (Bev) 10mg/kg every 2 weeks plus TH-302 240mg/m2 every 2 weeks (in a 4 week cycle)
11068696|NCT01403610|OG001|Outcome|Cohort 2|Bevacizumab (Bev) 10mg/kg every 2 weeks plus TH-302 340mg/m2 every 2 weeks (in a 4 week cycle)
11068697|NCT01403610|OG002|Outcome|Cohort 3|Bevacizumab (Bev) 10mg/kg every 2 weeks plus TH-302 480 mg/m2 every 2 weeks (in a 4 week cycle)
11068698|NCT01403610|OG003|Outcome|Cohort 4|Bevacizumab (Bev) 10mg/kg every 2 weeks plus TH-302 470 mg/m2 every 2 weeks (in a 4 week cycle)
11068699|NCT01403610|EG000|Reported Event|Cohort 1|240 mg/m2 dosage
11068700|NCT01403610|EG001|Reported Event|Cohort 2|340 mg/m2 dosage
11068701|NCT01403610|EG002|Reported Event|Cohort 3|480 mg/m2 dosage
11068702|NCT01403610|EG003|Reported Event|Cohort 4|670 mg/m2
11068703|NCT01403805|BG000|Baseline|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
11068704|NCT01403805|BG001|Baseline|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
11068705|NCT01403805|BG002|Baseline|Total|Total of all reporting groups
11068706|NCT01403805|FG000|Participant Flow|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
11068707|NCT01403805|FG001|Participant Flow|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
11068708|NCT01403805|OG000|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
11068709|NCT01403805|OG001|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
11068710|NCT01403805|OG000|Outcome|Leaving Nursing Home|Numer of resident for leaving nursing home
11068711|NCT01403805|OG000|Outcome|Reject Oral Care|Number of resident to reject oral care
11068712|NCT01403805|OG000|Outcome|Reject Vaccine|Number of resident to reject vaccine
11068713|NCT01403805|OG000|Outcome|Died Before Oral Care Starting|Number of resident died before the start of oral care
10887558|NCT00501059|BG000|Baseline|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
11068714|NCT01403805|EG000|Reported Event|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
11068715|NCT01403805|EG001|Reported Event|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
11068716|NCT01403987|BG000|Baseline|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
11068717|NCT01403987|BG001|Baseline|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
11068718|NCT01403987|BG002|Baseline|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
11068719|NCT01403987|BG003|Baseline|Total|Total of all reporting groups
11068720|NCT01403987|FG000|Participant Flow|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
11068721|NCT01403987|FG001|Participant Flow|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
11068722|NCT01403987|FG002|Participant Flow|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
11068723|NCT01403987|OG000|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
11068724|NCT01403987|OG001|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
11068725|NCT01403987|OG002|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
11068726|NCT01403987|EG000|Reported Event|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
11068727|NCT01403987|EG001|Reported Event|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
11068728|NCT01403987|EG002|Reported Event|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
11068729|NCT01404039|BG000|Baseline|Motor Learning (ML)|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
11068730|NCT01404039|BG001|Baseline|Somatosensory Learning (SL Sighted)|
11068731|NCT01404039|BG002|Baseline|Somatosensory Learning (SL Blind)|
11068732|NCT01404039|BG003|Baseline|Somatosensory Activation (S Activation)|
11068733|NCT01404039|BG004|Baseline|Somatosensory Learning (SL) Control Group|
11068734|NCT01404039|BG005|Baseline|Observational Task (OT) - Real|
11068735|NCT01404039|BG006|Baseline|Observational Task (OT) - Control|
11068736|NCT01404039|BG007|Baseline|Mental Imagery (MI) - Real|
11068737|NCT01404039|BG008|Baseline|Mental Imagery (MI) - Control|
11068738|NCT01404039|BG009|Baseline|Total|Total of all reporting groups
11068739|NCT01404039|FG000|Participant Flow|Motor Learning - MLsighted/MLblind/MLcontrol|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
11068740|NCT01404039|FG001|Participant Flow|Motor Learning (ML) MLblind/MLcontrol/MLsighted|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
11068741|NCT01404039|FG002|Participant Flow|Motor Learning (ML) MLcontrol Group/MLsighted/MLblind|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
11068742|NCT01404039|FG003|Participant Flow|Somatosensory Learning (SL Sighted)|"In this arm, subject will perform sensory Learning with visual feedback - SL sighted.~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
11068743|NCT01404039|FG004|Participant Flow|Somatosensory Learning (SL Blind)|"In this arm, subject will perform sensory Learning without visual feedback - SL blind.~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
11068744|NCT01404039|FG005|Participant Flow|Somatosensory Activation (S Activation)|"In this arm, subject will receive simple sensory stimulation over their left index finger - Sactivation.~There will be an anticipated total of 10 subjects in this experimental arm.This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
11068745|NCT01404039|FG006|Participant Flow|Somatosensory Learning (SL) Control Group|"In this arm,the subjects will not receive any somatosensory input (SL control group).~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
11068746|NCT01404039|FG007|Participant Flow|Observational Task (OT)|Observational Task: Subjects in this group will watch a 10 second video of a right-handed person performing movements of their left index finger at a 1 Hz rate on a screen at a distance of 1 meter away. Subjects will be instructed to watch the video without any other specific instruction.
11068747|NCT01404039|FG008|Participant Flow|Observational Task (OT) - Control Group|Control Group -- Observational Task: Subjects in this group will be asked to watch a video of random geometric forms for the same duration of time as those in the observational task group.
11068748|NCT01404039|FG009|Participant Flow|Mental Imagery (MI)|Mental Imagery: Subjects will be seated in a chair and are asked to keep their arm and hand muscles fully relaxed. Then they will be asked to imagine repetitive movement of the left index finger to the left thumb for 5 minutes. Subjects then will be asked to imagine sequential movement of left finger to left thumb (thumb to 2nd, 3rd, 4th, 5th) for 5 minutes.
11068749|NCT01404039|FG010|Participant Flow|Mental Imagery (MI) - Control Group|Control Group - Mental Imagery: Subjects will be asked to perform simple mental math calculations for 20 minutes. (ex. adding or subtracting a one digit number from a starting number (1+1=2; 2+1=3; 3+1= 4 and so on.)
11068750|NCT01404039|FG011|Participant Flow|tDCS - Active|This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
11068751|NCT01404039|FG012|Participant Flow|tDCS - Sham|This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
11068752|NCT01404039|OG000|Outcome|Motor Learning (ML)-Sighted|
11068753|NCT01404039|OG001|Outcome|Motor Learning -ML Blind|
11068754|NCT01404039|OG002|Outcome|Motor Learning - ML Control|
11068755|NCT01404039|OG003|Outcome|Somatosensory Learning (SL)- SL Sighted|
11068756|NCT01404039|OG004|Outcome|Somatosensory Learning (SL)-SL Blind|
11068757|NCT01404039|OG005|Outcome|Somatosensory Learning (SL)-SL Activation|
11068758|NCT01404039|OG006|Outcome|Somatosensory Learning (SL)-SL Control|
11068759|NCT01404039|OG007|Outcome|Observational Task (OT)- OT Real|
11068760|NCT01404039|OG008|Outcome|Observational Task (OT)- OT Control|
11068761|NCT01404039|OG009|Outcome|Mental Imagery (MI) - MI Real|
11068762|NCT01404039|OG010|Outcome|Mental Imagery (MI) - MI Control|
11068763|NCT01404039|EG000|Reported Event|Motor Learning (ML) Sighted|
11068764|NCT01404039|EG001|Reported Event|Motor Learning (ML) Blind|
11068765|NCT01404039|EG002|Reported Event|Motor Learning (ML) Control|
11068766|NCT01404039|EG003|Reported Event|Somatosensory Learning (SL) Sighted|
11068767|NCT01404039|EG004|Reported Event|Somatosensory Learning (SL) Blind|
11068768|NCT01404039|EG005|Reported Event|Somatosensory Activation (SA)|
11068769|NCT01404039|EG006|Reported Event|Somatosensory Learning (SL) Control|
11068770|NCT01404039|EG007|Reported Event|Observational Task (OT) - Real|
11068771|NCT01404039|EG008|Reported Event|Observational Task (OT) - Control|
11068772|NCT01404039|EG009|Reported Event|Mental Imagery (MI) - Real|
11068773|NCT01404039|EG010|Reported Event|Mental Imagery (MI) - Control|
11068774|NCT01404078|BG000|Baseline|Polycap Single Dose|Patients in this arm received single dose of low strength Polycap only Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
11068775|NCT01404078|BG001|Baseline|Polycap Double Dose Plus Potassium|"Patients in this arm received one dose of low strength Polycap with potassium~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
11068776|NCT01404078|BG002|Baseline|Total|Total of all reporting groups
11068777|NCT01404078|FG000|Participant Flow|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
11068778|NCT01404078|FG001|Participant Flow|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
11068779|NCT01404078|OG000|Outcome|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
11068780|NCT01404078|OG001|Outcome|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
11068781|NCT01404078|EG000|Reported Event|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
11068782|NCT01404078|EG001|Reported Event|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
11068783|NCT01404208|BG000|Baseline|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
11068784|NCT01404208|BG001|Baseline|Sugar Pill|Placebo: Sugar pill
11068785|NCT01404208|BG002|Baseline|Total|Total of all reporting groups
11068786|NCT01404208|FG000|Participant Flow|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
11068787|NCT01404208|FG001|Participant Flow|Sugar Pill|Placebo: Sugar pill
11068788|NCT01404208|OG000|Outcome|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
11068789|NCT01404208|OG001|Outcome|Sugar Pill|Placebo: Sugar pill
11068790|NCT01404208|EG000|Reported Event|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
11068791|NCT01404208|EG001|Reported Event|Sugar Pill|Placebo: Sugar pill
11068792|NCT01404234|BG000|Baseline|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
11068793|NCT01404234|FG000|Participant Flow|AZLI|Participants received three 28-day courses of Aztreonam for Inhalation Solution (AZLI), each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
11068794|NCT01404234|OG000|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
11068795|NCT01404234|EG000|Reported Event|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
11068796|NCT01404260|BG000|Baseline|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
11068797|NCT01404260|BG001|Baseline|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
11068798|NCT01404260|BG002|Baseline|Total|Total of all reporting groups
11068799|NCT01404260|FG000|Participant Flow|Arm A: Gefitinib + Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
11068800|NCT01404260|FG001|Participant Flow|Arm B: Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
11068801|NCT01404260|OG000|Outcome|Arm A: Gefitinib+Gemcitabine +Carboplatin|Arm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
11068802|NCT01404260|OG001|Outcome|Arm B: Gemcitabine +Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
11068803|NCT01404260|EG000|Reported Event|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
11068804|NCT01404260|EG001|Reported Event|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
11068805|NCT01404325|BG000|Baseline|Quadruple Low Level IS Regimen|quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids
11068806|NCT01404325|BG001|Baseline|Centre Specific Triple IS Regimen|centre specific CNI-based triple drug immunosuppression (IS)
11068807|NCT01404325|BG002|Baseline|Total|Total of all reporting groups
11068808|NCT01404325|FG000|Participant Flow|Quadruple Low Level IS Regimen|quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids
11068809|NCT01404325|FG001|Participant Flow|Centre Specific Triple IS Regimen|centre specific CNI-based triple drug immunosuppression (IS)
11068810|NCT01404325|OG000|Outcome|Quadruple Low Level IS Regimen|quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids
10887559|NCT00501059|BG001|Baseline|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
11068811|NCT01404325|OG001|Outcome|Centre Specific Triple IS Regimen|centre specific CNI-based triple drug immunosuppression (IS)
11068812|NCT01404325|EG000|Reported Event|Quadruple Low Level IS Regimen|quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids
11068813|NCT01404325|EG001|Reported Event|Centre Specific Triple IS Regimen|centre specific CNI-based triple drug immunosuppression (IS)
11068814|NCT01404429|BG000|Baseline|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
11068815|NCT01404429|BG001|Baseline|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
11068816|NCT01404429|BG002|Baseline|Total|Total of all reporting groups
10887560|NCT00501059|BG002|Baseline|Total|Total of all reporting groups
11068817|NCT01404429|FG000|Participant Flow|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
11068818|NCT01404429|FG001|Participant Flow|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
11068819|NCT01404429|OG000|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
11068820|NCT01404429|OG001|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
11068821|NCT01404429|OG000|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
11068822|NCT01404429|OG001|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
11068823|NCT01404429|EG000|Reported Event|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
11068824|NCT01404429|EG001|Reported Event|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
11068825|NCT01404559|BG000|Baseline|Transtibial Amputees|This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention.
11068826|NCT01404559|BG001|Baseline|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
11068827|NCT01404559|BG002|Baseline|Total|Total of all reporting groups
11068828|NCT01404559|FG000|Participant Flow|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week).~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
11068829|NCT01404559|FG001|Participant Flow|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week).~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
10887561|NCT00501059|FG000|Participant Flow|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
10887562|NCT00501059|FG001|Participant Flow|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
10887563|NCT00501059|OG000|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
11068830|NCT01404559|FG002|Participant Flow|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week).~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
11068831|NCT01404559|FG003|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
11068832|NCT01404559|OG000|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
11068833|NCT01404559|OG001|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
11068834|NCT01404559|OG002|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
11068835|NCT01404559|OG003|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
11068836|NCT01404559|EG000|Reported Event|Unilateral Transtibial Amputees|This arm/group included unilateral transtibial amputees who who were assessed three times. They were exposed to 3 different prosthetic feet interventions.
11068837|NCT01404572|BG000|Baseline|All Treated|All participants tasted atazanavir, 15 mg/5 mL, in the current formulation and 2 new powder for oral use formulations in 3 different sequences
11068838|NCT01404572|FG000|Participant Flow|Treatment Sequence A, B, C|Participants in this sequence first tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame followed by at least a 45-minute washout period. Next, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose.
11068839|NCT01404572|FG001|Participant Flow|Treatment Sequence B, C, A|Participants in this sequence first tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following at least a 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose. Following another 45-minute washout period, participants then tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame.
11068840|NCT01404572|FG002|Participant Flow|Treatment Sequence C, A, B|Participants in this sequence first tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose followed by at least a 45-minute washout period. Next, participants tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame.
11068841|NCT01404572|OG000|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
11068842|NCT01404572|OG001|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
11068843|NCT01404572|OG002|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
11068844|NCT01404572|OG001|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted received atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
11068845|NCT01404572|OG002|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame+ 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
11068846|NCT01404572|OG002|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C).
11068847|NCT01404572|EG000|Reported Event|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A)
11068848|NCT01404572|EG001|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
11068849|NCT01404572|EG002|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
11068850|NCT01404611|BG000|Baseline|DF289|"Ear drops~DF289: Ear drops"
11068851|NCT01404611|BG001|Baseline|DF277|"Ear drops~DF277: Ear drops"
11068852|NCT01404611|BG002|Baseline|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
11068853|NCT01404611|BG003|Baseline|Total|Total of all reporting groups
11068854|NCT01404611|FG000|Participant Flow|DF289|"Ear drops~DF289: Ear drops"
11068855|NCT01404611|FG001|Participant Flow|DF277|"Ear drops~DF277: Ear drops"
11068856|NCT01404611|FG002|Participant Flow|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
11068857|NCT01404611|OG000|Outcome|DF289|"Ear drops~DF289: Ear drops"
11068858|NCT01404611|OG001|Outcome|DF277|"Ear drops~DF277: Ear drops"
11068859|NCT01404611|OG002|Outcome|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
11068860|NCT01404611|EG000|Reported Event|DF289|"Ear drops~DF289: Ear drops"
11068861|NCT01404611|EG001|Reported Event|DF277|"Ear drops~DF277: Ear drops"
11068862|NCT01404611|EG002|Reported Event|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
10887564|NCT00501059|OG001|Outcome|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
11068863|NCT01404650|BG000|Baseline|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
11068864|NCT01404650|FG000|Participant Flow|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
11068865|NCT01404650|OG000|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
11068866|NCT01404650|EG000|Reported Event|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
11068867|NCT01404832|BG000|Baseline|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
11068868|NCT01404832|FG000|Participant Flow|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
11068869|NCT01404832|OG000|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
11068870|NCT01404832|EG000|Reported Event|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
11068871|NCT01404923|BG000|Baseline|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
11068872|NCT01404923|BG001|Baseline|Standard of Care|anti spasmodic agents: best standard of care prescriptions
11068873|NCT01404923|BG002|Baseline|Total|Total of all reporting groups
11068874|NCT01404923|FG000|Participant Flow|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
11068875|NCT01404923|FG001|Participant Flow|Standard of Care|anti spasmodic agents: best standard of care prescriptions
11068876|NCT01404923|OG000|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
11068877|NCT01404923|OG001|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
11068878|NCT01404923|EG000|Reported Event|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
11068879|NCT01404923|EG001|Reported Event|Standard of Care|anti spasmodic agents: best standard of care prescriptions
11068880|NCT01404936|BG000|Baseline|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
11068881|NCT01404936|FG000|Participant Flow|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
11068882|NCT01404936|OG000|Outcome|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
11068883|NCT01404936|EG000|Reported Event|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
10887565|NCT00501059|OG000|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465) Per-protocol|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
10887566|NCT00501059|OG001|Outcome|Placebo Per-protocol|Subjects received 1 tablets of matching placebo orally once daily.
10887567|NCT00501059|EG000|Reported Event|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
11068884|NCT01404949|BG000|Baseline|Tretinoin and Arsenic Trioxide|"This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.~Tretinoin and Arsenic Trioxide: See Detailed Description"
11068885|NCT01404949|FG000|Participant Flow|Tretinoin and Arsenic Trioxide|"This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.~Tretinoin and Arsenic Trioxide: See Detailed Description"
11068886|NCT01404949|OG000|Outcome|Tretinoin and Arsenic Trioxide|"This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.~Tretinoin and Arsenic Trioxide: See Detailed Description"
11068887|NCT01404949|EG000|Reported Event|Tretinoin and Arsenic Trioxide|"This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.~Tretinoin and Arsenic Trioxide: See Detailed Description"
11068888|NCT01404988|BG000|Baseline|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.Behavioral Intervention will be delivered over the phone.
11068889|NCT01404988|BG001|Baseline|Behavioral and Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
11068890|NCT01404988|BG002|Baseline|Attention Placebo Intervention (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
11068891|NCT01404988|BG003|Baseline|Total|Total of all reporting groups
11068892|NCT01404988|FG000|Participant Flow|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement over the phone.
11068893|NCT01404988|FG001|Participant Flow|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
11068894|NCT01404988|FG002|Participant Flow|Attention Placebo Group (API) -|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
11068895|NCT01404988|OG000|Outcome|Comprehensive Behavioral Intervention (BI) -|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Behavioral Intervention will be delivered over the phone."
11068896|NCT01404988|OG001|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
11068897|NCT01404988|OG002|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
11068898|NCT01404988|OG000|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
11068899|NCT01404988|OG001|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
11068900|NCT01404988|OG000|Outcome|Comprehensive Behavioral Intervention (BI)|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Behavioral Intervention will be delivered over the phone."
11068901|NCT01404988|EG000|Reported Event|Arm 1|"Comprehensive behavioral intervention (BI) - Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Telephone-Delivered BI: Behavioral Intervention will be delivered over the phone."
11068902|NCT01404988|EG001|Reported Event|Arm 2|"Behavioral & Environmental Intervention (BEI) - Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.~Telephone-Delivered BEI: Behavioral and Environmental Intervention will be delivered over the phone"
11068903|NCT01404988|EG002|Reported Event|Arm 3|"Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.~Telephone-Delivered API: Attention Placebo Intervention will be delivered over the phone"
11068904|NCT01405027|BG000|Baseline|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068905|NCT01405027|BG001|Baseline|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068906|NCT01405027|BG002|Baseline|Total|Total of all reporting groups
11068907|NCT01405027|FG000|Participant Flow|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068908|NCT01405027|FG001|Participant Flow|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068909|NCT01405027|OG000|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068910|NCT01405027|OG001|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068911|NCT01405027|OG000|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.~Patient education and management skills training: Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068912|NCT01405027|OG001|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068913|NCT01405027|EG000|Reported Event|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
10887568|NCT00501059|EG001|Reported Event|Acetylsalicylic Acid|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally one daily.
11068914|NCT01405027|EG001|Reported Event|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
11068915|NCT01405053|BG000|Baseline|Rufinamide|Participants received rufinamide oral suspension as an add-on therapy to the participant's existing regimen of 1 to 3 AEDs. Participants underwent a 2 week Titration Period during which rufinamide dose was increased from 10 mg/kg/day in increments of 10 mg/kg/day every 3 days to 40 mg/kg/day and thereafter in increments of 5 mg/kg/day to the target maintenance dose of 45 mg/kg/day (all daily treatments were to be administered in 2 equally divided doses). Rufinamide dose reached at the end of the Titration period were to be maintained the same throughout the 104-week Maintenance Period. At the end of Maintenance Period, rufinamide dose should be tapered (as needed) over a period of 2 weeks.
11068916|NCT01405053|BG001|Baseline|Any Other Approved Antiepileptic Drug|Participants received any other approved AEDs of the investigator's choice, dosed according to the investigator's usual practice, added to the participant's existing regimen of 1 to 3 AEDs. At the end of Maintenance Period, the AED comparator would be discontinued according to the investigator's usual practice.
11068917|NCT01405053|BG002|Baseline|Total|Total of all reporting groups
11068918|NCT01405053|FG000|Participant Flow|Rufinamide|Participants received rufinamide oral suspension as an add-on therapy to the participant's existing regimen of 1 to 3 Antiepileptic Drugs (AEDs). Participants underwent a 2 week Titration Period during which rufinamide dose was increased from 10 milligram per kilogram per day (mg/kg/day) in increments of 10 mg/kg/day every 3 days to 40 mg/kg/day and thereafter in increments of 5 mg/kg/day to the target maintenance dose of 45 mg/kg/day (all daily treatments were to be administered in 2 equally divided doses). Rufinamide dose reached at the end of the Titration period were to be maintained the same throughout the 104-week Maintenance Period. At the end of Maintenance Period, rufinamide dose should be tapered (as needed) over a period of 2 weeks.
11068919|NCT01405053|FG001|Participant Flow|Any Other Approved Antiepileptic Drug|Participants received any other approved AEDs of the investigator's choice, dosed according to the investigator's usual practice, added to the participant's existing regimen of 1 to 3 AEDs. At the end of Maintenance Period, the AED comparator would be discontinued according to the investigator's usual practice.
11068920|NCT01405053|OG000|Outcome|Rufinamide|Participants received rufinamide oral suspension as an add-on therapy to the participant's existing regimen of 1 to 3 AEDs. Participants underwent a 2 week Titration Period during which rufinamide dose was increased from 10 mg/kg/day in increments of 10 mg/kg/day every 3 days to 40 mg/kg/day and thereafter in increments of 5 mg/kg/day to the target maintenance dose of 45 mg/kg/day (all daily treatments were to be administered in 2 equally divided doses). Rufinamide dose reached at the end of the Titration period were to be maintained the same throughout the 104-week Maintenance Period. At the end of Maintenance Period, rufinamide dose should be tapered (as needed) over a period of 2 weeks.
11068921|NCT01405053|OG001|Outcome|Any Other Approved Antiepileptic Drug|Participants received any other approved AEDs of the investigator's choice, dosed according to the investigator's usual practice, added to the participant's existing regimen of 1 to 3 AEDs. At the end of Maintenance Period, the AED comparator would be discontinued according to the investigator's usual practice.
11068922|NCT01405053|EG000|Reported Event|Rufinamide|Participants received rufinamide oral suspension as an add-on therapy to the participant's existing regimen of 1 to 3 AEDs. Participants underwent a 2 week Titration Period during which rufinamide dose was increased from 10 mg/kg/day in increments of 10 mg/kg/day every 3 days to 40 mg/kg/day and thereafter in increments of 5 mg/kg/day to the target maintenance dose of 45 mg/kg/day (all daily treatments were to be administered in 2 equally divided doses). Rufinamide dose reached at the end of the Titration period were to be maintained the same throughout the 104-week Maintenance Period. At the end of Maintenance Period, rufinamide dose should be tapered (as needed) over a period of 2 weeks.
11068923|NCT01405053|EG001|Reported Event|Any Other Approved Antiepileptic Drug|Participants received any other approved AEDs of the investigator's choice, dosed according to the investigator's usual practice, added to the participant's existing regimen of 1 to 3 AEDs. At the end of Maintenance Period, the AED comparator would be discontinued according to the investigator's usual practice.
11068924|NCT01405196|BG000|Baseline|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068925|NCT01405196|BG001|Baseline|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068926|NCT01405196|BG002|Baseline|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
10887569|NCT00501085|BG000|Baseline|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
11068927|NCT01405196|BG003|Baseline|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068928|NCT01405196|BG004|Baseline|Total|Total of all reporting groups
11068929|NCT01405196|FG000|Participant Flow|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068930|NCT01405196|FG001|Participant Flow|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068931|NCT01405196|FG002|Participant Flow|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068932|NCT01405196|FG003|Participant Flow|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068933|NCT01405196|OG000|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068934|NCT01405196|OG001|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068935|NCT01405196|OG002|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068936|NCT01405196|OG002|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068937|NCT01405196|OG003|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068938|NCT01405196|EG000|Reported Event|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068939|NCT01405196|EG001|Reported Event|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068940|NCT01405196|EG002|Reported Event|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068941|NCT01405196|EG003|Reported Event|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
11068942|NCT01405313|BG000|Baseline|Modified ASV/Conventional ASV|Therapy used was Modified ASV and then Conventional ASV
11068943|NCT01405313|FG000|Participant Flow|First Modified ASV Then Conventional ASV|Patients receive Modified ASV algorithm as therapy for 1 night, then Conventional ASV for 1 night
11068944|NCT01405313|OG000|Outcome|Modified ASV AHI|1 night of modified ASV therapy with full polysomnography measurements
11068945|NCT01405313|OG001|Outcome|Conventional ASV AHI|1 night of conventional ASV therapy with full polysomnography measurements
11068946|NCT01405313|OG000|Outcome|Modified ASV ODI|1 night of modified ASV therapy with full polysomnography measurements
11173501|NCT02015819|OG003|Outcome|Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11068947|NCT01405313|OG001|Outcome|Conventional ASV ODI|1 night of conventional ASV therapy with full polysomnography measurements
11068948|NCT01405313|EG000|Reported Event|Conventional ASV|Intervention was conventional ASV therapy
11068949|NCT01405313|EG001|Reported Event|Modified ASV|Intervention was modified ASV therapy
11068950|NCT01405456|BG000|Baseline|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
11068951|NCT01405456|BG001|Baseline|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
11068952|NCT01405456|BG002|Baseline|Total|Total of all reporting groups
11068953|NCT01405456|FG000|Participant Flow|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
11068954|NCT01405456|FG001|Participant Flow|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
11068955|NCT01405456|OG000|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
11068956|NCT01405456|OG001|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
11068957|NCT01405456|EG000|Reported Event|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
11068958|NCT01405456|EG001|Reported Event|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
11068959|NCT01405469|BG000|Baseline|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
11068960|NCT01405469|FG000|Participant Flow|POEM Patients|pilot group of achalasia patients who received POEM Treatment: Endoscopic Myotomy of the Lower Esophageal Sphincter
11068961|NCT01405469|OG000|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
11068962|NCT01405469|OG000|Outcome|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
11068963|NCT01405469|EG000|Reported Event|POEM Patients|pilot group of achalasia patients who received POEM treatment
11068964|NCT01405508|BG000|Baseline|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068965|NCT01405508|BG001|Baseline|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068966|NCT01405508|BG002|Baseline|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
11068967|NCT01405508|BG003|Baseline|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068968|NCT01405508|BG004|Baseline|Total Title|
11068969|NCT01405508|FG000|Participant Flow|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068970|NCT01405508|FG001|Participant Flow|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068971|NCT01405508|FG002|Participant Flow|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
11068972|NCT01405508|FG003|Participant Flow|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068973|NCT01405508|OG000|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068974|NCT01405508|OG001|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11226916|NCT02378844|OG001|Outcome|gammaCore®-R Sham|"Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).~gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side)."
11068975|NCT01405508|OG002|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
11068976|NCT01405508|OG003|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068977|NCT01405508|EG000|Reported Event|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068978|NCT01405508|EG001|Reported Event|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068979|NCT01405508|EG002|Reported Event|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
11068980|NCT01405508|EG003|Reported Event|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
11068981|NCT01405560|BG000|Baseline|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
11068982|NCT01405560|FG000|Participant Flow|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
11068983|NCT01405560|OG000|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
11068984|NCT01405560|EG000|Reported Event|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
11068985|NCT01405742|BG000|Baseline|Severe Hemophilia A|"Subjects will be randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo Cross-Over, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period."
11068986|NCT01405742|FG000|Participant Flow|Once-Weekly Then Thrice-Weekly FVIII|"Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo Cross-Over, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks."
11068987|NCT01405742|FG001|Participant Flow|Thrice-Weekly Then Once-Weekly FVIII|"Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo Cross-Over, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks."
11068988|NCT01405742|OG000|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
11068989|NCT01405742|OG001|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
11068990|NCT01405742|EG000|Reported Event|Arm A Once-weekly F.VIII at 40 IU/kg|"Subjects in Arm A will be randomized to receive either once-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo Cross-Over, that is, switch to the alternative Study Arm (thrice-weekly) for the last 26 weeks, following a 72 hour washout period."
11226917|NCT02378844|OG002|Outcome|Not Randomized|Subjects that were screen failures and were not randomized.
11068991|NCT01405742|EG001|Reported Event|Arm B Thrice-weekly F.VIII at 40 IU/kg|"Subjects will be randomized to receive thrice-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo Cross-Over, that is, switch to the alternative Study Arm (once-weekly) for the last 26 weeks, following a 72 hour washout period."
11068992|NCT01405768|BG000|Baseline|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
11068993|NCT01405768|BG001|Baseline|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
11068994|NCT01405768|BG002|Baseline|Total|Total of all reporting groups
11068995|NCT01405768|FG000|Participant Flow|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
11068996|NCT01405768|FG001|Participant Flow|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
11068997|NCT01405768|OG000|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
11068998|NCT01405768|OG001|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
11068999|NCT01405768|EG000|Reported Event|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
11069000|NCT01405768|EG001|Reported Event|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
11069001|NCT01405794|BG000|Baseline|All Participants|
11335665|NCT03554629|OG002|Outcome|15 Second LOW RR 18 Alarm With Actual Respiration Rate of 24|False Low RR for 15 - 29 seconds with patient interface gas sample for capnography derived respiration measurement under condition of subject respiration rate of 24 with supplemental O2 at 5lpm.
11069002|NCT01405794|FG000|Participant Flow|All Study Participants|All participants were dosed with the placebo (14 days), then they all had a 72hr washout period. Last all participants were dosed with the 32ppm Oral Silver for (14 days).
11069003|NCT01405794|OG000|Outcome|Placebo|
11069004|NCT01405794|OG001|Outcome|32ppm Oral Silver|
11069005|NCT01405794|EG000|Reported Event|ASAP 32 Ppm Solution Experimental|
11069006|NCT01405794|EG001|Reported Event|Silver Biotics 32 Ppm Diluent|
11069007|NCT01405820|BG000|Baseline|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
11069008|NCT01405820|BG001|Baseline|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
11069009|NCT01405820|BG002|Baseline|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
11069010|NCT01405820|BG003|Baseline|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
11069011|NCT01405820|BG004|Baseline|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
11069012|NCT01405820|BG005|Baseline|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
11069013|NCT01405820|BG006|Baseline|Total|Total of all reporting groups
11069014|NCT01405820|FG000|Participant Flow|Natalizumab 300 mg Intravenous (IV) Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069015|NCT01405820|FG001|Participant Flow|Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069016|NCT01405820|FG002|Participant Flow|Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069017|NCT01405820|FG003|Participant Flow|Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069018|NCT01405820|FG004|Participant Flow|Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069019|NCT01405820|FG005|Participant Flow|Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069020|NCT01405820|OG000|Outcome|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
11069021|NCT01405820|OG001|Outcome|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
11069022|NCT01405820|OG002|Outcome|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
11069023|NCT01405820|OG003|Outcome|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
11069024|NCT01405820|OG004|Outcome|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
11069025|NCT01405820|OG005|Outcome|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
11069026|NCT01405820|EG000|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
11069027|NCT01405820|EG001|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
11069028|NCT01405820|EG002|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
11069029|NCT01405820|EG003|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
11069030|NCT01405820|EG004|Reported Event|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
11069031|NCT01405820|EG005|Reported Event|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
11069032|NCT01405820|EG006|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069033|NCT01405820|EG007|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069034|NCT01405820|EG008|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069035|NCT01405820|EG009|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069036|NCT01405820|EG010|Reported Event|Open-label Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069037|NCT01405820|EG011|Reported Event|Open-label Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
11069038|NCT01405898|BG000|Baseline|Beetroot Juice|Beetroot juice 4 weeks 250ml daily
11069039|NCT01405898|BG001|Baseline|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
11069040|NCT01405898|BG002|Baseline|Total|Total of all reporting groups
10887570|NCT00501085|FG000|Participant Flow|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
11069041|NCT01405898|FG000|Participant Flow|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
11069042|NCT01405898|FG001|Participant Flow|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
11069043|NCT01405898|OG000|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
11069044|NCT01405898|OG001|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
11069045|NCT01405898|EG000|Reported Event|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
11069046|NCT01405898|EG001|Reported Event|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
11069047|NCT01405911|BG000|Baseline|Placebo|Participants received one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
11069048|NCT01405911|BG001|Baseline|Sitagliptin 25 mg|Participants received one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
11069049|NCT01405911|BG002|Baseline|Sitagliptin 50 mg|Participants received one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.
11069050|NCT01405911|BG003|Baseline|Total|Total of all reporting groups
11069051|NCT01405911|FG000|Participant Flow|Placebo|Participants received one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
11069052|NCT01405911|FG001|Participant Flow|Sitagliptin 25 mg|Participants received one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
11069053|NCT01405911|FG002|Participant Flow|Sitagliptin 50 mg|Participants received one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.
11069054|NCT01405911|OG000|Outcome|Placebo|Participants received one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
11069055|NCT01405911|OG001|Outcome|Sitagliptin 25 mg|Participants received one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
11069056|NCT01405911|OG002|Outcome|Sitagliptin 50 mg|Participants received one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.
11069057|NCT01405911|EG000|Reported Event|Placebo|Participants received one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
11069058|NCT01405911|EG001|Reported Event|Sitagliptin 25 mg|Participants received one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
11069059|NCT01405911|EG002|Reported Event|Sitagliptin 50 mg|Participants received one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.
11069060|NCT01405924|BG000|Baseline|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
11335666|NCT03554629|OG003|Outcome|30 Second LOW RR 18 With Actual Respiration Rate of 24|False Low RR for 15- 29 seconds with CCSF gas sample for capnography measurement.
11069061|NCT01405924|FG000|Participant Flow|Fosaprepitant 150 mg|Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
11069062|NCT01405924|OG000|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
11069063|NCT01405924|OG000|Outcome|Fosaprepitant 150 mg: AC-like Chemotherapy|Women with breast cancer receiving AC-like chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
11069064|NCT01405924|OG001|Outcome|Fosaprepitant 150 mg: CT Chemotherapy|Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
11069065|NCT01405924|EG000|Reported Event|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
11069066|NCT01405937|BG000|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
11069067|NCT01405937|BG001|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
11069068|NCT01405937|BG002|Baseline|Total|Total of all reporting groups
11226918|NCT02378844|OG003|Outcome|Open Label|Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).
11069069|NCT01405937|FG000|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
11069070|NCT01405937|FG001|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
11069071|NCT01405937|OG000|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
11069072|NCT01405937|OG001|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
11069073|NCT01405937|EG000|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
11069074|NCT01405937|EG001|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
11069075|NCT01405950|BG000|Baseline|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
11069076|NCT01405950|BG001|Baseline|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
11069077|NCT01405950|BG002|Baseline|Total|Total of all reporting groups
11069078|NCT01405950|FG000|Participant Flow|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
11069079|NCT01405950|FG001|Participant Flow|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
11069080|NCT01405950|FG002|Participant Flow|Dose Level 3|Zanaflex Capsules : 0.075 mg/kg
11069081|NCT01405950|FG003|Participant Flow|Dose Level 4|Zanaflex Capsules : 0.1 mg/kg
11069082|NCT01405950|OG000|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
11069083|NCT01405950|OG001|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
11069084|NCT01405950|OG002|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
11069085|NCT01405950|OG003|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
11069086|NCT01405950|EG000|Reported Event|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
11069087|NCT01405950|EG001|Reported Event|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
11091776|NCT01536184|FG000|Participant Flow|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
11091777|NCT01536184|FG001|Participant Flow|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
11091778|NCT01536184|OG000|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
11091779|NCT01536184|OG001|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
11069088|NCT01406015|BG000|Baseline|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
11069089|NCT01406015|BG001|Baseline|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
11069090|NCT01406015|BG002|Baseline|Total|Total of all reporting groups
11069091|NCT01406015|FG000|Participant Flow|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
11069092|NCT01406015|FG001|Participant Flow|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
11069093|NCT01406015|OG000|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
11069094|NCT01406015|OG001|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
11069095|NCT01406015|EG000|Reported Event|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
11069096|NCT01406015|EG001|Reported Event|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
11069097|NCT01406223|BG000|Baseline|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
11069098|NCT01406223|BG001|Baseline|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
11069099|NCT01406223|BG002|Baseline|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
11069100|NCT01406223|BG003|Baseline|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
11069101|NCT01406223|BG004|Baseline|Total|Total of all reporting groups
11335667|NCT03554629|OG004|Outcome|15 Second LOW RR 6 Alarm With Actual Respiration Rate of 24|False Low RR for 15 - 29 seconds with patient interface gas sample for capnography derived respiration measurement under condition of subject respiration rate of 24 with supplemental O2 at 5lpm.
10887571|NCT00501085|OG000|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
11069102|NCT01406223|FG000|Participant Flow|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
11069103|NCT01406223|FG001|Participant Flow|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
11069104|NCT01406223|FG002|Participant Flow|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
11069105|NCT01406223|FG003|Participant Flow|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
11069106|NCT01406223|OG000|Outcome|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
11069107|NCT01406223|OG001|Outcome|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
11069108|NCT01406223|OG002|Outcome|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
11069109|NCT01406223|OG003|Outcome|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
11069110|NCT01406223|EG000|Reported Event|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
11069111|NCT01406223|EG001|Reported Event|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
11069112|NCT01406223|EG002|Reported Event|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
11069113|NCT01406223|EG003|Reported Event|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
11069114|NCT01406444|BG000|Baseline|rhIGF-1 Followed by Risedronate|Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
11069115|NCT01406444|BG001|Baseline|Risedronate|Risedronate 35mg PO once weekly for 12 months
11069116|NCT01406444|BG002|Baseline|Placebo|Placebo for 12 months
11069117|NCT01406444|BG003|Baseline|Total|Total of all reporting groups
11069118|NCT01406444|FG000|Participant Flow|rhIGF-1 Followed by Risedronate|Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
11069119|NCT01406444|FG001|Participant Flow|Risedronate|Risedronate 35mg PO once weekly for 12 months
11069120|NCT01406444|FG002|Participant Flow|Placebo|Placebo for 12 months
11069121|NCT01406444|OG000|Outcome|rhIGF-1 Followed by Risedronate|Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
11069122|NCT01406444|OG001|Outcome|Risedronate|Risedronate 35mg PO once weekly for 12 months
11069123|NCT01406444|OG002|Outcome|Placebo|Placebo for 12 months
11069124|NCT01406444|EG000|Reported Event|rhIGF-1 Followed by Risedronate|Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
11069125|NCT01406444|EG001|Reported Event|Risedronate|Risedronate 35mg PO once weekly for 12 months
11069126|NCT01406444|EG002|Reported Event|Placebo|Placebo for 12 months
11069127|NCT01406574|BG000|Baseline|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
11069128|NCT01406574|FG000|Participant Flow|OPB-31121: 50mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
11069129|NCT01406574|FG001|Participant Flow|OPB-31121: 100mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
11069130|NCT01406574|FG002|Participant Flow|OPB-31121: 200mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
11069131|NCT01406574|FG003|Participant Flow|OPB-31121: 400mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
11069132|NCT01406574|OG000|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
11069133|NCT01406574|OG000|Outcome|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
11069134|NCT01406574|OG001|Outcome|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
11069135|NCT01406574|OG002|Outcome|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
11069136|NCT01406574|OG003|Outcome|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
11069137|NCT01406574|EG000|Reported Event|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
11069138|NCT01406574|EG001|Reported Event|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
11069139|NCT01406574|EG002|Reported Event|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
11069140|NCT01406574|EG003|Reported Event|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
11069141|NCT01406652|BG000|Baseline|One-stage Bursectomy|Bursectomy with debridement and primary closure of the wound during one surgical intervention
11069142|NCT01406652|BG001|Baseline|Two-stage Bursectomy|Two-stage bursectomy: Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
11069143|NCT01406652|BG002|Baseline|Total|Total of all reporting groups
11069144|NCT01406652|FG000|Participant Flow|One-stage Bursectomy|79 patients undergo surgical bursectomy and wound closure within the same Operation.
11069145|NCT01406652|FG001|Participant Flow|Two-stage Bursectomy|85 patients have a two-stage Approach. First, they undergo surgical bursectomy with the wound left open. In a second step 3-4 days later, they are re-operated for wound closure.
11069146|NCT01406652|OG000|Outcome|One-stage Bursectomy|Total costs in Swiss francs of the one-stage bursectomy approach and associated treatment.
11069147|NCT01406652|OG001|Outcome|Two-stage Bursectomy|Total costs in Swiss francs of the one-stage bursectomy approach and associated treatment.
11069148|NCT01406652|OG000|Outcome|One-stage Bursectomy|Bursectomy with debridement and primary closure of the wound during one surgical intervention
11069149|NCT01406652|OG001|Outcome|Two-stage Bursectomy|Two-stage bursectomy: Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
11069150|NCT01406652|EG000|Reported Event|One-versus Bursectomy|Bursectomy and surgical wound closure during the same surgery
11069151|NCT01406652|EG001|Reported Event|Two-stage Busectomy|Bursectomy during the first surgery, followed by a surgical closure in a second step.
11069152|NCT01406717|BG000|Baseline|SPIL1033|"SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.~168 are the number of subjects in mITT population"
11069153|NCT01406717|BG001|Baseline|Placebo|"Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.~170 are the number of subjects in mTT population."
11069154|NCT01406717|BG002|Baseline|Total|Total of all reporting groups
11069155|NCT01406717|FG000|Participant Flow|SPIL1033|SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
11069156|NCT01406717|FG001|Participant Flow|Placebo|Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
11069157|NCT01406717|OG000|Outcome|SPIL1033|SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
11069158|NCT01406717|OG001|Outcome|Placebo|Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
11069159|NCT01406717|OG000|Outcome|SPIL1033|SPIL1033, Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. he number of subjects in the population for the analysis of FPG are 110.
11069160|NCT01406717|OG001|Outcome|Placebo|SPIL1033, Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. he number of subjects in the population for the analysis of FPG are 94.
11069161|NCT01406717|OG000|Outcome|SPIL1033|SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in the evaluated anti-exenatide antibodies are 133.
11069162|NCT01406717|OG001|Outcome|Placebo|Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluated anti-exenatide antibodies population are 143.
11069163|NCT01406717|OG000|Outcome|SPIL1033|SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in the safety population are 179.
11069164|NCT01406717|OG001|Outcome|Placebo|Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in the safety population are 178.
11069165|NCT01406717|OG000|Outcome|SPIL1033|SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
11069166|NCT01406717|OG001|Outcome|Placebo|Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
11069167|NCT01406717|OG000|Outcome|SPIL1033|SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in the population for the analysis of HbA1c are 112.
11069168|NCT01406717|OG001|Outcome|Placebo|Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. he number of subjects in the population for the analysis of HbA1c are 94.
11069169|NCT01406717|EG000|Reported Event|SPIL1033|SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
11069170|NCT01406717|EG001|Reported Event|Placebo|Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
11069171|NCT01406795|BG000|Baseline|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
11069172|NCT01406795|FG000|Participant Flow|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
11069173|NCT01406795|OG000|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
11069174|NCT01406795|EG000|Reported Event|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
11069175|NCT01406873|BG000|Baseline|Mexiletine|This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
11069176|NCT01406873|BG001|Baseline|Placebo|This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
11069177|NCT01406873|BG002|Baseline|Total|Total of all reporting groups
11069178|NCT01406873|FG000|Participant Flow|Mexiletine|This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
11069179|NCT01406873|FG001|Participant Flow|Placebo|This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
11069180|NCT01406873|OG000|Outcome|Mexiletine|Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069181|NCT01406873|OG001|Outcome|Placebo|Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069182|NCT01406873|OG000|Outcome|Mexiletine|Percentage of Participants that had a dose Reduction or a Study Drug Withdrawal or Suspension for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069183|NCT01406873|OG001|Outcome|Placebo|Percentage of Participants that had a dose Reduction or a Study Drug Withdrawal or Suspension for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11226919|NCT02378844|EG000|Reported Event|gammaCore®-R|"Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).~gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side)."
11226920|NCT02378844|EG001|Reported Event|gammaCore®-R Sham|"Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).~gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side)."
10887572|NCT00501085|EG000|Reported Event|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
11069184|NCT01406873|OG000|Outcome|Mexiletine|Mean Change from Baseline in Quantitative Measure of Hand Grip Myotonia for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069185|NCT01406873|OG001|Outcome|Placebo|Mean Change from Baseline in Quantitative Measure of Hand Grip Myotonia for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069186|NCT01406873|OG000|Outcome|Mexiletine|Mean Change from Baseline in Manual Muscle Testing (MMT) Score for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069187|NCT01406873|OG001|Outcome|Placebo|Mean Change from Baseline in Manual Muscle Testing (MMT) Score for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069188|NCT01406873|OG000|Outcome|Mexiletine|This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
11069189|NCT01406873|OG001|Outcome|Placebo|This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
11069190|NCT01406873|OG000|Outcome|Mexiletine|Mean Change from Baseline in Patient-Reported Disease Burden and Quality of Life for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11226921|NCT02378844|EG002|Reported Event|Not Randomised|Subjects that were screen failures and were not randomized.
11069191|NCT01406873|OG001|Outcome|Placebo|Mean Change from Baseline in Patient-Reported Disease Burden and Quality of Life for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
10887573|NCT00501293|BG000|Baseline|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
11069192|NCT01406873|EG000|Reported Event|Mexiletine|Adverse Events for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069193|NCT01406873|EG001|Reported Event|Placebo|Adverse Events for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
11069194|NCT01406938|BG000|Baseline|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
11069195|NCT01406938|BG001|Baseline|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
11069196|NCT01406938|BG002|Baseline|Total|Total of all reporting groups
11069197|NCT01406938|FG000|Participant Flow|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
11069198|NCT01406938|FG001|Participant Flow|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
11069199|NCT01406938|FG002|Participant Flow|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
11069200|NCT01406938|FG003|Participant Flow|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
11069201|NCT01406938|FG004|Participant Flow|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
11069202|NCT01406938|FG005|Participant Flow|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
11069203|NCT01406938|OG000|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
11069204|NCT01406938|OG001|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
11226922|NCT02378844|EG003|Reported Event|Open Label|Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).
10887574|NCT00501293|BG001|Baseline|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
11069205|NCT01406938|OG002|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
10887575|NCT00501293|BG002|Baseline|Total|Total of all reporting groups
10887576|NCT00501293|FG000|Participant Flow|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
10887577|NCT00501293|FG001|Participant Flow|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
10887578|NCT00501293|OG000|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
10887579|NCT00501293|OG001|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
10887580|NCT00501293|OG000|Outcome|Antecedent MTS and Antecedent Placebo|Methylphenidate Transdermal System and Placebo Patch
10887581|NCT00501293|EG000|Reported Event|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
10887582|NCT00501293|EG001|Reported Event|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
10887583|NCT00501540|BG000|Baseline|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
10887584|NCT00501540|FG000|Participant Flow|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
10887585|NCT00501540|OG000|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
10887586|NCT00501540|EG000|Reported Event|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
10887587|NCT00501592|BG000|Baseline|25 mg INT-747|Once daily by mouth
10887588|NCT00501592|BG001|Baseline|50 mg INT-747|Once daily by mouth
10887589|NCT00501592|BG002|Baseline|Placebo|Once daily by mouth
10887590|NCT00501592|BG003|Baseline|Total|Total of all reporting groups
10887591|NCT00501592|FG000|Participant Flow|25 mg INT-747|Once daily by mouth
10887592|NCT00501592|FG001|Participant Flow|50 mg INT-747|Once daily by mouth
10887593|NCT00501592|FG002|Participant Flow|Placebo|Once daily by mouth
10887594|NCT00501592|OG000|Outcome|25 mg INT-747|Once daily by mouth
10887595|NCT00501592|OG001|Outcome|50 mg INT-747|Once daily by mouth
10887596|NCT00501592|OG002|Outcome|Placebo|Once daily by mouth
10887597|NCT00501592|EG000|Reported Event|25 mg INT-747|Once daily by mouth
10887598|NCT00501592|EG001|Reported Event|50 mg INT-747|Once daily by mouth
10887599|NCT00501592|EG002|Reported Event|Placebo|Once daily by mouth
10887600|NCT00501631|BG000|Baseline|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
10887601|NCT00501631|BG001|Baseline|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
10887602|NCT00501631|BG002|Baseline|Total|Total of all reporting groups
11069206|NCT01406938|OG003|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
11069207|NCT01406938|OG004|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
11069208|NCT01406938|OG005|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
11069209|NCT01406938|EG000|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
11069210|NCT01406938|EG001|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
11069211|NCT01406938|EG002|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
11069212|NCT01406938|EG003|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
11069213|NCT01406938|EG004|Reported Event|ENTIRE-AIN457 150 mg SoR|ENTIRE-AIN457 150 mg SoR
11069214|NCT01406938|EG005|Reported Event|ENTIRE-AIN457 300 mg SoR|ENTIRE-AIN457 300 mg SoR
11069215|NCT01406938|EG006|Reported Event|FOLLOW UP-AIN457 150mg IPO|FOLLOW UP-AIN457 150mg IPO
11069216|NCT01406938|EG007|Reported Event|FOLLOW UP-AIN457 300mg IPO|FOLLOW UP-AIN457 300mg IPO
11069217|NCT01406938|EG008|Reported Event|FOLLOW UP-AIN457 150 mg|FOLLOW UP-AIN457 150 mg
11069218|NCT01406938|EG009|Reported Event|FOLLOW UP-AIN457 300 mg|FOLLOW UP-AIN457 300 mg
11069219|NCT01406938|EG010|Reported Event|FOLLOW UP-AIN457 150 mg SoR|FOLLOW UP-AIN457 150 mg SoR
11069220|NCT01406938|EG011|Reported Event|FOLLOW UP-AIN457 300 mg SoR|FOLLOW UP-AIN457 300 mg SoR
11069221|NCT01406990|BG000|Baseline|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
11069222|NCT01406990|FG000|Participant Flow|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
11069223|NCT01406990|OG000|Outcome|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
11069224|NCT01406990|EG000|Reported Event|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
11069225|NCT01407068|BG000|Baseline|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
11069226|NCT01407068|FG000|Participant Flow|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
11069227|NCT01407068|OG000|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
11069228|NCT01407068|OG000|Outcome|AA4500 MP|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the metacarpophalangeal (MP) joint cord"
11069229|NCT01407068|OG001|Outcome|AA4500 PIP|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the interphalangeal (PIP) joint cord"
11069230|NCT01407068|EG000|Reported Event|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
11069231|NCT01407094|BG000|Baseline|Sertraline|"SSRI monotherapy~Sertraline: 50-200mg/day"
11069232|NCT01407094|BG001|Baseline|Placebo|"Placebo control~Placebo: 1-4 pills per day"
11069233|NCT01407094|BG002|Baseline|BupropionXL|"BupropionXL~150-450mg/day"
11069234|NCT01407094|BG003|Baseline|Total|Total of all reporting groups
11069235|NCT01407094|FG000|Participant Flow|Sertraline|"SSRI monotherapy~Sertraline: 50-200mg/day"
11069236|NCT01407094|FG001|Participant Flow|Placebo|"Placebo control~Placebo: 1-4 pills per day"
11069237|NCT01407094|FG002|Participant Flow|BupropionXL|"BupropionXL~150-450 mg/day~Other names: WelbutrinXL"
11069238|NCT01407094|OG000|Outcome|Sertraline|"SSRI monotherapy~Sertraline: 50-200mg/day"
11069239|NCT01407094|OG001|Outcome|Placebo|"Placebo control~Placebo: 1-4 pills per day"
11069240|NCT01407094|OG002|Outcome|BupropionXL|"BupropionXL~150-450mg/day"
11069241|NCT01407094|EG000|Reported Event|Sertraline|"SSRI monotherapy~Sertraline: 50-200mg/day"
11069242|NCT01407094|EG001|Reported Event|Placebo|"Placebo control~Placebo: 1-4 pills per day"
11069243|NCT01407094|EG002|Reported Event|BupropionXL|"BupropionXL~150-450 mg/day"
11069244|NCT01407107|BG000|Baseline|Cohort 1|Dose escalation trial of Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
11069245|NCT01407107|BG001|Baseline|Cohort 2|nitroglycerin: 0.4 mg/hr nitroglycerin transdermal patch daily
11069246|NCT01407107|BG002|Baseline|Cohort 3|nitroglycerin: 0.6 mg/hr nitroglycerin transdermal patch daily
11069247|NCT01407107|BG003|Baseline|Total|Total of all reporting groups
11069248|NCT01407107|FG000|Participant Flow|Nitroglycerin 0.2mg/hr Cohort 1|Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
11069249|NCT01407107|FG001|Participant Flow|Nitroglycerin 0.4mg/hr Cohort 2|Nitroglycerin: 0.4mg/hr nitroglycerin transdermal patch daily
11069250|NCT01407107|FG002|Participant Flow|Nitroglycerin: 0.6mg/hr Cohort 3|Nitroglycerin: 0.6mg/hr nitroglycerin transdermal patch daily
11069251|NCT01407107|OG000|Outcome|Cohort 1|Dose escalation trial of Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
11069252|NCT01407107|OG001|Outcome|Cohort 2|nitroglycerin: 0.4 mg/hr nitroglycerin transdermal patch daily
11069253|NCT01407107|OG002|Outcome|Cohort 3|nitroglycerin: 0.6 mg/hr nitroglycerin transdermal patch daily
11069254|NCT01407107|EG000|Reported Event|Cohort 1|Dose escalation trial of Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
11069255|NCT01407107|EG001|Reported Event|Cohort 2|nitroglycerin: 0.4 mg/hr nitroglycerin transdermal patch daily
11069256|NCT01407107|EG002|Reported Event|Cohort 3|nitroglycerin: 0.6 mg/hr nitroglycerin transdermal patch daily
11069257|NCT01407276|BG000|Baseline|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
11069258|NCT01407276|BG001|Baseline|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
11069259|NCT01407276|BG002|Baseline|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
11069260|NCT01407276|BG003|Baseline|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
11069261|NCT01407276|BG004|Baseline|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
11069262|NCT01407276|BG005|Baseline|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
11069263|NCT01407276|BG006|Baseline|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
11069264|NCT01407276|BG007|Baseline|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
11069265|NCT01407276|BG008|Baseline|Total|Total of all reporting groups
11069266|NCT01407276|FG000|Participant Flow|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
11069267|NCT01407276|FG001|Participant Flow|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
11069268|NCT01407276|FG002|Participant Flow|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
11069269|NCT01407276|FG003|Participant Flow|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
11069270|NCT01407276|FG004|Participant Flow|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
11069271|NCT01407276|FG005|Participant Flow|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
11069272|NCT01407276|FG006|Participant Flow|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
10887603|NCT00501631|FG000|Participant Flow|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
11069273|NCT01407276|FG007|Participant Flow|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
11069274|NCT01407276|OG000|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
11069275|NCT01407276|OG001|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
11069276|NCT01407276|OG002|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
11069277|NCT01407276|OG003|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
11069278|NCT01407276|OG004|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
11069279|NCT01407276|OG005|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
11069280|NCT01407276|OG006|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
11069281|NCT01407276|OG007|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
11069282|NCT01407276|OG008|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
11069283|NCT01407276|OG009|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
11069284|NCT01407276|OG006|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
11069285|NCT01407276|OG007|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
11069286|NCT01407276|OG009|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
11069287|NCT01407276|OG009|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from the study was not included.
11069288|NCT01407276|OG006|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
11069289|NCT01407276|EG000|Reported Event|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
11069290|NCT01407276|EG001|Reported Event|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
11069291|NCT01407276|EG002|Reported Event|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
11069292|NCT01407276|EG003|Reported Event|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
11069293|NCT01407276|EG004|Reported Event|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
11069294|NCT01407276|EG005|Reported Event|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
11069295|NCT01407276|EG006|Reported Event|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
11069296|NCT01407276|EG007|Reported Event|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
11069297|NCT01407354|BG000|Baseline|All Study Participants|Baseline data reflects all participants who received both aquatic exercise and lokomat training during the study.
11069298|NCT01407354|FG000|Participant Flow|Lokomat First Then Aquatic Exercise|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session, participants received aquatic exercise after lokomat"
11069299|NCT01407354|FG001|Participant Flow|Aquatic Therapy First Then Lokomat Intervention|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session, participants received lokomat intervention after aquatic exercise"
11069300|NCT01407354|OG000|Outcome|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
11069301|NCT01407354|OG001|Outcome|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
11069302|NCT01407354|OG000|Outcome|Lokomat|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session,"
11069303|NCT01407354|EG000|Reported Event|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
11069304|NCT01407354|EG001|Reported Event|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
11069305|NCT01407367|BG000|Baseline|Phase I|"Phase I (first 108 participants enrolled):~Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs"
11069306|NCT01407367|BG001|Baseline|Phase II|"Phase II (subsequent 242 participants enrolled):~Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs"
11226923|NCT02378883|BG000|Baseline|APOLLO|The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
11069307|NCT01407367|BG002|Baseline|Total|Total of all reporting groups
11069308|NCT01407367|FG000|Participant Flow|Phase I|Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069309|NCT01407367|FG001|Participant Flow|Phase II|Phase II (subsequent 242 participants enrolled) Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069310|NCT01407367|OG000|Outcome|Phase I|Phase I Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069311|NCT01407367|OG001|Outcome|Phase II|Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069312|NCT01407367|OG000|Outcome|Phase I|Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069313|NCT01407367|OG001|Outcome|Phase II|Phase II (subsequent 242 participants enrolled) Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069314|NCT01407367|OG000|Outcome|Phase I|Phase I Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069315|NCT01407367|EG000|Reported Event|Phase I|Phase I Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069316|NCT01407367|EG001|Reported Event|Phase II|Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
11069317|NCT01407523|BG000|Baseline|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
11069318|NCT01407523|FG000|Participant Flow|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
11069319|NCT01407523|OG000|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
11069320|NCT01407523|EG000|Reported Event|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
11069321|NCT01407575|BG000|Baseline|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
11069322|NCT01407575|BG001|Baseline|Placebo|Placebo: matched placebo
11069323|NCT01407575|BG002|Baseline|Total|Total of all reporting groups
11069324|NCT01407575|FG000|Participant Flow|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
11069325|NCT01407575|FG001|Participant Flow|Placebo|Placebo: matched placebo
11069326|NCT01407575|OG000|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
11069327|NCT01407575|OG001|Outcome|Placebo|Placebo: matched placebo
11069328|NCT01407575|OG000|Outcome|Buprenorphine|"0.2 to 1.6mg of buprenorphine sublingual over the course of 8 weeks~Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)"
11069329|NCT01407575|OG001|Outcome|Placebo|"matching placebo- sublingual- over the course of 8 weeks~Placebo: matched placebo"
11069330|NCT01407575|EG000|Reported Event|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
11069331|NCT01407575|EG001|Reported Event|Placebo|Placebo: matched placebo
11069332|NCT01407926|BG000|Baseline|Nurse-Led Mental Health Promotion Group|"Interprofessional nurse-led strategy involving regular home visits over 6 months by an RN and PSW. The RN will conduct a comprehensive health assessment and screen clients for risk factors for depression and other chronic conditions, implement health promotion strategies to address this risk factors and enhance health, review their medications, conduct in-home exercise , refer clients to other health services~Nurse-Led Mental Health Promotion Intervention : The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach."
11069333|NCT01407926|FG000|Participant Flow|Nurse-Led Mental Health Promotion Group|"Interprofessional nurse-led strategy involving regular home visits over 6 months by an RN and PSW. The RN will conduct a comprehensive health assessment and screen clients for risk factors for depression and other chronic conditions, implement health promotion strategies to address this risk factors and enhance health, review their medications, conduct in-home exercise , refer clients to other health services~Nurse-Led Mental Health Promotion Intervention : The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach."
11069334|NCT01407926|OG000|Outcome|Nurse-Led Mental Health Promotion Group|"Interprofessional nurse-led strategy involving regular home visits over 6 months by an RN and PSW. The RN will conduct a comprehensive health assessment and screen clients for risk factors for depression and other chronic conditions, implement health promotion strategies to address this risk factors and enhance health, review their medications, conduct in-home exercise , refer clients to other health services~Nurse-Led Mental Health Promotion Intervention : The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach."
11069335|NCT01407926|OG000|Outcome|Nurse-Led Mental Health Promotion Group|"Interprofessional nurse-led strategy involving regular home visits over 6 months by an RN and PSW. The RN will conduct a comprehensive health assessment and screen clients for risk factors for depression and other chronic conditions, implement health promotion strategies to address this risk factors and enhance health, review their medications, conduct in-home exercise , refer clients to other health services~Nurse-Led Mental Health Promotion Intervention: The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach."
11069336|NCT01407926|EG000|Reported Event|Nurse-Led Mental Health Promotion Group|"Interprofessional nurse-led strategy involving regular home visits over 6 months by an RN and PSW. The RN will conduct a comprehensive health assessment and screen clients for risk factors for depression and other chronic conditions, implement health promotion strategies to address this risk factors and enhance health, review their medications, conduct in-home exercise , refer clients to other health services~Nurse-Led Mental Health Promotion Intervention : The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach."
11069337|NCT01407952|BG000|Baseline|HydroCoil Embolic System|"Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)~HydroCoil Embolic System: HydroCoil Embolic System"
11069338|NCT01407952|BG001|Baseline|Control|"Aneurysm treatment using bare platinum coil(s)~Control (bare platinum coils): bare platinum coils"
11069339|NCT01407952|BG002|Baseline|Total|Total of all reporting groups
11069340|NCT01407952|FG000|Participant Flow|HydroCoil Embolic System|"Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)~HydroCoil Embolic System: HydroCoil Embolic System"
11069341|NCT01407952|FG001|Participant Flow|Control|"Aneurysm treatment using bare platinum coil(s)~Control (bare platinum coils): bare platinum coils"
11069342|NCT01407952|OG000|Outcome|HydroCoil Embolic System|"Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)~HydroCoil Embolic System: HydroCoil Embolic System"
11069343|NCT01407952|OG001|Outcome|Control|"Aneurysm treatment using bare platinum coil(s)~Control (bare platinum coils): bare platinum coils"
11069344|NCT01407952|EG000|Reported Event|HydroCoil Embolic System|"Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)~HydroCoil Embolic System: HydroCoil Embolic System"
11069345|NCT01407952|EG001|Reported Event|Control|"Aneurysm treatment using bare platinum coil(s)~Control (bare platinum coils): bare platinum coils"
11069346|NCT01408030|BG000|Baseline|Bevacizumab Spray|Bevacizumab: 1% solution in saline, 0.1 ml spray in each nostril bid
11069347|NCT01408030|BG001|Baseline|Estriol Spray|Estriol: 0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid
11069348|NCT01408030|BG002|Baseline|Tranexamic Acid Spray|Tranexamic Acid: 10% solution in saline, 0.1 ml spray in each nostril bid
11069349|NCT01408030|BG003|Baseline|Placebo Spray|Sterile saline: 0.9%, 0.1 ml spray in each nostril bid
11069350|NCT01408030|BG004|Baseline|Total|Total of all reporting groups
11069351|NCT01408030|FG000|Participant Flow|Bevacizumab Spray|Bevacizumab: 1% solution in saline, 0.1 ml spray in each nostril bid
11069352|NCT01408030|FG001|Participant Flow|Estriol Spray|Estriol: 0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid
11069353|NCT01408030|FG002|Participant Flow|Tranexamic Acid Spray|Tranexamic Acid: 10% solution in saline, 0.1 ml spray in each nostril bid
11069354|NCT01408030|FG003|Participant Flow|Placebo Spray|Sterile saline: 0.9%, 0.1 ml spray in each nostril bid
11069355|NCT01408030|OG000|Outcome|Bevacizumab Spray|Bevacizumab: 1% solution in saline, 0.1 ml spray in each nostril bid
11069356|NCT01408030|OG001|Outcome|Estriol Spray|Estriol: 0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid
11069357|NCT01408030|OG002|Outcome|Tranexamic Acid Spray|Tranexamic Acid: 10% solution in saline, 0.1 ml spray in each nostril bid
11069358|NCT01408030|OG003|Outcome|Placebo Spray|Sterile saline: 0.9%, 0.1 ml spray in each nostril bid
11069359|NCT01408030|EG000|Reported Event|Bevacizumab Spray|Bevacizumab: 1% solution in saline, 0.1 ml spray in each nostril bid
11069360|NCT01408030|EG001|Reported Event|Estriol Spray|Estriol: 0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid
11069361|NCT01408030|EG002|Reported Event|Tranexamic Acid Spray|Tranexamic Acid: 10% solution in saline, 0.1 ml spray in each nostril bid
11069362|NCT01408030|EG003|Reported Event|Placebo Spray|Sterile saline: 0.9%, 0.1 ml spray in each nostril bid
11069363|NCT01408043|BG000|Baseline|Treatment (Stem Cell Supermobilization)|"Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.~plerixafor: Given SC~filgrastim: Given SC~etoposide: Given IV~leukapheresis: Undergo apheresis"
11069364|NCT01408043|FG000|Participant Flow|Treatment (Stem Cell Supermobilization)|"Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.~plerixafor: Given SC~filgrastim: Given SC~etoposide: Given IV~leukapheresis: Undergo apheresis"
11226924|NCT02378883|FG000|Participant Flow|APOLLO|The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
11226925|NCT02378883|OG000|Outcome|AVM Treatment|Apollo™ Onyx™ Delivery Microcatheter
11226926|NCT02378883|OG000|Outcome|APOLLO|The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
11069365|NCT01408043|OG000|Outcome|Treatment (Stem Cell Supermobilization)|"Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.~plerixafor: Given SC~filgrastim: Given SC~etoposide: Given IV~leukapheresis: Undergo apheresis"
11069366|NCT01408043|EG000|Reported Event|Treatment (Stem Cell Supermobilization)|"Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.~plerixafor: Given SC~filgrastim: Given SC~etoposide: Given IV~leukapheresis: Undergo apheresis"
11069367|NCT01408147|BG000|Baseline|Treatment Group|"This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.~Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings."
11069368|NCT01408147|BG001|Baseline|Standard WIC Care|The control group will received Standard Care as provided through WIC.
11069369|NCT01408147|BG002|Baseline|Total|Total of all reporting groups
11069370|NCT01408147|FG000|Participant Flow|Treatment Group|"This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.~Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings."
11069371|NCT01408147|FG001|Participant Flow|Standard WIC Care|The control group will received Standard Care as provided through WIC.
11069372|NCT01408147|OG000|Outcome|Treatment Group|"This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.~Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings."
11069373|NCT01408147|OG001|Outcome|Standard WIC Care|The control group will received Standard Care as provided through WIC.
11069374|NCT01408147|EG000|Reported Event|Treatment Group|"This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.~Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings."
11069375|NCT01408147|EG001|Reported Event|Standard WIC Care|The control group will received Standard Care as provided through WIC.
11069376|NCT01408277|BG000|Baseline|Santyl|Collagenase (SANTYL®) Ointment
11069377|NCT01408277|BG001|Baseline|Control|Standard Care
11069378|NCT01408277|BG002|Baseline|Total|Total of all reporting groups
11069379|NCT01408277|FG000|Participant Flow|Santyl|Collagenase (SANTYL®) Ointment
11069380|NCT01408277|FG001|Participant Flow|Control|Standard Care
11069381|NCT01408277|OG000|Outcome|Santyl®|Collagenase (Santyl®) Ointment
11069382|NCT01408277|OG001|Outcome|Control|"Control = Standard Care~Standard Care is defined as the standard wound care protocol for chronic wounds used by each Investigator, in their clinic (e.g., wet-to-dry, compression, sharp debridement, etc.)."
11069383|NCT01408277|EG000|Reported Event|Santyl|Collagense (Santyl®) Ointment
11069384|NCT01408277|EG001|Reported Event|Control|Standard Care
11069385|NCT01408303|BG000|Baseline|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
11069386|NCT01408303|BG001|Baseline|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
11069387|NCT01408303|BG002|Baseline|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
11069388|NCT01408303|BG003|Baseline|Total|Total of all reporting groups
11069389|NCT01408303|FG000|Participant Flow|Epanova, 2 g + Statin|"omega-3 carboxylic acids, 1 g capsule~omega-3 carboxylic acids + olive oil: omega-3 carboxylic acids 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks~prescribe statin"
11069390|NCT01408303|FG001|Participant Flow|Epanova, 4 g + Statin|"omega-3 carboxylic acids, 1 g capsule~omega-3 carboxylic acids: omega-3 carboxylic acids 4 x 1 g capsule daily for 6 weeks~prescribed statin"
11069391|NCT01408303|FG002|Participant Flow|Olive Oil + Statin|"olive oil, 1 g capsule~olive oil: 4 x 1 g capsule daily for 6 weeks~prescribed statin"
11069392|NCT01408303|OG000|Outcome|Epanova 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo: omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
11069393|NCT01408303|OG001|Outcome|Epanova 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
11069394|NCT01408303|OG002|Outcome|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
11069395|NCT01408303|EG000|Reported Event|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
11069396|NCT01408303|EG001|Reported Event|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
11069397|NCT01408303|EG002|Reported Event|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
11069398|NCT01408329|BG000|Baseline|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
11069399|NCT01408329|BG001|Baseline|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
11069400|NCT01408329|BG002|Baseline|Total|Total of all reporting groups
11069401|NCT01408329|FG000|Participant Flow|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
11069402|NCT01408329|FG001|Participant Flow|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
11069403|NCT01408329|OG000|Outcome|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
11069404|NCT01408329|OG001|Outcome|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6097m
11069405|NCT01408329|EG000|Reported Event|Sham Group|Slowly fluctuating simulated altitude up to 607 meters.
11069406|NCT01408329|EG001|Reported Event|Cyclic Hypoxic Group|Rapidly fluctuating simulated altitude up to 6097 meters
11069407|NCT01408459|BG000|Baseline|Tomato Product|Tomato Product: Motivational Telephone Counseling weekly
11069408|NCT01408459|BG001|Baseline|Control|"No Motivation telephone Counseling~Control: No Motivational telephone Counseling"
11069409|NCT01408459|BG002|Baseline|Total|Total of all reporting groups
11069410|NCT01408459|FG000|Participant Flow|Tomato Product|Tomato Product: Motivational Telephone Counseling weekly
11069411|NCT01408459|FG001|Participant Flow|Control|"No Motivation telephone Counseling~Control: No Motivational telephone Counseling"
11069412|NCT01408459|OG000|Outcome|Tomato Product|Tomato Product: Motivational Telephone Counseling weekly
11069413|NCT01408459|OG001|Outcome|Control|"No Motivation telephone Counseling~Control: No Motivational telephone Counseling"
11069414|NCT01408459|OG000|Outcome|Tomato Product|"Motivational telephone counseling weekly~Tomato Product: Motivational Telephone Counseling weekly"
11069415|NCT01408459|EG000|Reported Event|Tomato Product|Tomato Product: Motivational Telephone Counseling weekly
11069416|NCT01408459|EG001|Reported Event|Control|"No Motivation telephone Counseling~Control: No Motivational telephone Counseling"
11069417|NCT01408485|BG000|Baseline|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
11069418|NCT01408485|FG000|Participant Flow|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
11069419|NCT01408485|OG000|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
11226927|NCT02378883|EG000|Reported Event|APOLLO|The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
11069420|NCT01408485|EG000|Reported Event|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
11069421|NCT01408537|BG000|Baseline|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
11069422|NCT01408537|FG000|Participant Flow|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
11069423|NCT01408537|OG000|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
11069424|NCT01408537|OG000|Outcome|GMT of NT on 28days After Vaccination|GMT of NT titer of subjects on 28 days after vaccination (excluded the subject who had NT titer > =10 before first vaccination).
11069425|NCT01408537|OG001|Outcome|GMT of NT Before Booster Vaccine|GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
11069426|NCT01408537|OG002|Outcome|GMT of NT Titer After Booster Vaccine|GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
11069427|NCT01408537|OG000|Outcome|Fever After Vaccination|Fever (Temp > =37.5 Axillary )after each vaccinations (3 doses). Episode of fever was collected up to 28 days after each vaccination.
11069428|NCT01408537|OG001|Outcome|Local AE JEVAC After Vaccination|"Local Adverse event (tenderness, redness, ecchymosis, hematoma and swelling) after each vaccinations the first vaccination was on day of enrollment, the second dose was Day7 (+21day))~, Booster vaccine was on 1 year(+30days). Local AEs were collected up to 28 days after each vaccination."
11069429|NCT01408537|OG002|Outcome|Chills After Vaccination|Chills after each vaccinations (3 doses). Episode of chills was collected up to 28 days after each vaccination.
11069430|NCT01408537|OG003|Outcome|Poor Appetite After Vaccination|Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.
11069431|NCT01408537|OG004|Outcome|Vomiting After Vaccination|Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.
11069432|NCT01408537|OG005|Outcome|Urticaria After Vaccination|Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.
11069433|NCT01408537|OG006|Outcome|Unsolicited AEs After Each Vaccination|unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination
11069434|NCT01408537|OG007|Outcome|SAEs Entire the Study|SAEs which occured entire the study period were recorded.
11069435|NCT01408537|EG000|Reported Event|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
11069436|NCT01408563|BG000|Baseline|Fludarabine/Melphalan/TBI|"All patients receive same therapy~Fludarabine: 30 mg/m2/day IV x 6 days~Melphalan: 100 mg/m2/day IV x 1 day~Total Body Radiation: 200 cGy on Day 0~Cord Blood: 2 cord blood units IV"
11069437|NCT01408563|FG000|Participant Flow|Fludarabine/Melphalan/TBI|"All patients receive same therapy~Fludarabine: 30 mg/m2/day IV x 6 days~Melphalan: 100 mg/m2/day IV x 1 day~Total Body Radiation: 200 cGy on Day 0~Cord Blood: 2 cord blood units IV"
11069438|NCT01408563|OG000|Outcome|Fludarabine/Melphalan/TBI|"All patients receive same therapy~Fludarabine: 30 mg/m2/day IV x 6 days~Melphalan: 100 mg/m2/day IV x 1 day~Total Body Radiation: 200 cGy on Day 0~Cord Blood: 2 cord blood units IV"
11069439|NCT01408563|EG000|Reported Event|Fludarabine/Melphalan/TBI|"All patients receive same therapy~Fludarabine: 30 mg/m2/day IV x 6 days~Melphalan: 100 mg/m2/day IV x 1 day~Total Body Radiation: 200 cGy on Day 0~Cord Blood: 2 cord blood units IV"
11069440|NCT01408576|BG000|Baseline|Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)|Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069441|NCT01408576|BG001|Baseline|Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)|"Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2~1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles"
11069442|NCT01408576|BG002|Baseline|Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)|"Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2~600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles"
11069443|NCT01408576|BG003|Baseline|Total Title|
11069444|NCT01408576|FG000|Participant Flow|Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)|Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069445|NCT01408576|FG001|Participant Flow|Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)|"Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2~1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles"
11069446|NCT01408576|FG002|Participant Flow|Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)|"Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2~600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles"
11069447|NCT01408576|OG000|Outcome|Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)|Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069448|NCT01408576|OG001|Outcome|Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)|"Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2~1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles"
11069449|NCT01408576|OG002|Outcome|Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)|"Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2~600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles"
11069450|NCT01408576|OG003|Outcome|All Epratuzumab 600 mg Per Week|600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069451|NCT01408576|OG004|Outcome|All Subjects|Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
11069452|NCT01408576|OG000|Outcome|Enrollment Cohort 1 Epratuzumab 600 mg Per Week|Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069453|NCT01408576|OG001|Outcome|Enrollment Cohort 2 Epratuzumab 1200 mg Q2W|Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
11069454|NCT01408576|OG002|Outcome|Enrollment Cohort 2 Epratuzumab 600 mg Per Week|Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069455|NCT01408576|OG000|Outcome|Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)|"Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.~Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles"
11069456|NCT01408576|OG001|Outcome|Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)|"Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.~Subjects were enrolled prior to the approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles"
11069457|NCT01408576|OG002|Outcome|Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1)|"Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.~Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles"
11069458|NCT01408576|OG003|Outcome|All Epratuzumab 600 mg Per Week (FASS1)|"Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.~Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles"
11069459|NCT01408576|OG004|Outcome|All Subjects (FASS1)|"Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.~Subjects were enrolled prior to the approval of Protocol Amendment 2. Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles"
11069460|NCT01408576|EG000|Reported Event|Enrollment Cohort 1 Epratuzumab 600 mg Per Week|Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069461|NCT01408576|EG001|Reported Event|Enrollment Cohort 2 Epratuzumab 1200 mg Q2W|Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
11069462|NCT01408576|EG002|Reported Event|Enrollment Cohort 2 Epratuzumab 600 mg Per Week|Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069463|NCT01408576|EG003|Reported Event|All Epratuzumab 600 mg Per Week|600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
11069464|NCT01408576|EG004|Reported Event|All Subjects|Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
11069465|NCT01408628|BG000|Baseline|Internet Insulin Education|"Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (live) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm."
11069466|NCT01408628|FG000|Participant Flow|Internet Insulin Education|"Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (live) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm."
11069467|NCT01408628|OG000|Outcome|Internet Insulin Education|"Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (live) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of ≤ 7.0% using an established treat-to-target algorithm."
11069468|NCT01408628|OG000|Outcome|Internet Insulin Education|"Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (live) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm."
11069469|NCT01408628|EG000|Reported Event|Internet Insulin Education|"Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (live) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm."
11069470|NCT01408706|BG000|Baseline|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
11069471|NCT01408706|BG001|Baseline|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
11069472|NCT01408706|BG002|Baseline|Total|Total of all reporting groups
11069473|NCT01408706|FG000|Participant Flow|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
11069474|NCT01408706|FG001|Participant Flow|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
11069475|NCT01408706|OG000|Outcome|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
11069476|NCT01408706|OG001|Outcome|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
11069477|NCT01408706|OG000|Outcome|Miller Enema Air Tip|The Miller enema air tip rectal balloon is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy.
11069478|NCT01408706|OG001|Outcome|Radiadyne Immobilizer Treatment Device|The Radiadyne Immobilizer Treatment Device is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy
11069479|NCT01408706|EG000|Reported Event|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
11069480|NCT01408706|EG001|Reported Event|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
11069481|NCT01408719|BG000|Baseline|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
11069482|NCT01408719|BG001|Baseline|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
11069483|NCT01408719|BG002|Baseline|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
11069484|NCT01408719|BG003|Baseline|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
11069485|NCT01408719|BG004|Baseline|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
11069486|NCT01408719|BG005|Baseline|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
11069487|NCT01408719|BG006|Baseline|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
11069488|NCT01408719|BG007|Baseline|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
11069489|NCT01408719|BG008|Baseline|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
11069490|NCT01408719|BG009|Baseline|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
11069491|NCT01408719|BG010|Baseline|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
11069492|NCT01408719|BG011|Baseline|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
11069493|NCT01408719|BG012|Baseline|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
11069494|NCT01408719|BG013|Baseline|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
11069495|NCT01408719|BG014|Baseline|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
11069496|NCT01408719|BG015|Baseline|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
11069497|NCT01408719|BG016|Baseline|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
11069498|NCT01408719|BG017|Baseline|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
11069499|NCT01408719|BG018|Baseline|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
11069500|NCT01408719|BG019|Baseline|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
11069501|NCT01408719|BG020|Baseline|Total|Total of all reporting groups
11069502|NCT01408719|FG000|Participant Flow|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
11069503|NCT01408719|FG001|Participant Flow|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
11069504|NCT01408719|FG002|Participant Flow|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
11069505|NCT01408719|FG003|Participant Flow|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
11069506|NCT01408719|FG004|Participant Flow|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
11069507|NCT01408719|FG005|Participant Flow|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
11069508|NCT01408719|FG006|Participant Flow|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
11069509|NCT01408719|FG007|Participant Flow|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
11069510|NCT01408719|FG008|Participant Flow|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
11069511|NCT01408719|FG009|Participant Flow|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
11069512|NCT01408719|FG010|Participant Flow|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
11069513|NCT01408719|FG011|Participant Flow|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
11069514|NCT01408719|FG012|Participant Flow|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
11069515|NCT01408719|FG013|Participant Flow|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
11069516|NCT01408719|FG014|Participant Flow|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
11069517|NCT01408719|FG015|Participant Flow|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
11069518|NCT01408719|FG016|Participant Flow|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
11069519|NCT01408719|FG017|Participant Flow|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
11069520|NCT01408719|FG018|Participant Flow|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
10887604|NCT00501631|FG001|Participant Flow|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
10887605|NCT00501631|OG000|Outcome|Vivitrol|
11069521|NCT01408719|FG019|Participant Flow|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
11069522|NCT01408719|OG000|Outcome|5g LMW Beta Glucan|"5 gram low molecular weight barley beta-glucan diet for 35 days~Control: Minimal beta-glucan"
11069523|NCT01408719|OG001|Outcome|3g HMW Beta Glucan|"3 gram high molecular weight barley beta-glucan diet for 35 days~3g LMW beta-glucan: 3grams beta-glucan"
11069524|NCT01408719|OG002|Outcome|3g LMW Beta Glucan|"3 grams of low molecular weight beta-glucan diet for 35 days~5g LMW beta-glucan: 5 grams beta-glucan"
11069525|NCT01408719|OG003|Outcome|Control|"control diet containing negligible amount of beta glucan~3g HMW beta-glucan: 3 grams of high molecular weight beta-glucan"
11069526|NCT01408719|EG000|Reported Event|Control|Minimal barley and minimal beta-glucan
11069527|NCT01408719|EG001|Reported Event|3g HMW Beta-glucan|3 grams high molecular weight barley beta-glucan
11069528|NCT01408719|EG002|Reported Event|3g LMW Beta-glucan|3 grams low molecular weight barley beta-glucan
11069529|NCT01408719|EG003|Reported Event|5g LMW Beta-glucan|5 grams low molecular weight barley beta-glucan
10887606|NCT00501631|OG001|Outcome|Placebo|
11069530|NCT01408732|BG000|Baseline|Entire Study Population|
11069531|NCT01408732|FG000|Participant Flow|Sclerotherapy Intervention Then Standard Treatment|This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. Washout period of 2 weeks
11069532|NCT01408732|FG001|Participant Flow|Standard Treatment Then Sclerotherapy|"The standard treatment group will continue their pre-study standard treatment methods to treat epistaxis on the first 6 weeks of the study, followed by intervention with sclerotherapy on the second 6 weeks of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Wash out period 2 weeks"
11069533|NCT01408732|OG000|Outcome|Sclerotherapy Intervention|"This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. On the second period of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, and septodermoplasty.~Sodium tetradecyl sulfate (sotradecol): 3% Sodium tetradecyl sulfate (STS) is mixed with air at a ratio of 4 parts air to 1 part STS for injection into the affected vessels in the nose. Topical anesthetic is applied to the nasal mucosa prior to injections. Once the mixture is ready for injection, the needle is placed into the vessel, in a submucosal fashion, penetrating 1-2 mm, and very small quantities of foam are injected"
11069534|NCT01408732|OG001|Outcome|Standard Treatment|"The standard treatment group will continue their pre-study standard treatment methods to treat epistaxis on the first period of the study, followed by intervention with sclerotherapy on the second period of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, septodermoplasty, and any other treatments that the patient reports using that are accepted as standard of care.~Sodium tetradecyl sulfate (STS) is injected into the nasal lesions as a solution prepared by foaming STS with air at a 4:1 ratio. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. Multiple lesions can be treated bilaterally, each with a separate injection.~Standard Treatment"
11069535|NCT01408732|EG000|Reported Event|Sclerotherapy Intervention|"This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. On the second period of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, and septodermoplasty.~Individual injection amounts vary between lesions, patients and treatment sessions. No more than 3 ml of solution is used in each session."
11069536|NCT01408732|EG001|Reported Event|Standard Treatment|"The standard treatment group will continue their pre-study standard treatment methods to treat epistaxis on the first period of the study, followed by intervention with sclerotherapy on the second period of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, septodermoplasty, and any other treatments that the patient reports using that are accepted as standard of care.~Sodium tetradecyl sulfate (STS) is injected into the nasal lesions as a solution prepared by foaming STS with air at a 4:1 ratio. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. Multiple lesions can be treated bilaterally, each with a separate injection.~Standard Treatment"
11226928|NCT02378935|BG000|Baseline|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
10887607|NCT00501631|EG000|Reported Event|VIVITROL 380 mg (Double-blind Period)|
11069537|NCT01408862|BG000|Baseline|Controls|Platelets from healthy human subjects who were not taken any medication in the previous 10 days were studied. Blood samples (30 ml) were drawn with i) ACD-C (9:1, v/v) (7 mmol/L citric acid, 93 mmol/L citrate, 139 mmol/L dextrose, pH 6.4) for gene expression and western blot studies; ii) with 1% EDTA for flow cytometry and iii) with 3.8% sodium citrate for functional studies. Blood samples were centrifuged at 150 g for 10 min to obtain platelet-rich plasma (PRP).
11069538|NCT01408862|FG000|Participant Flow|Controls|"20 healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
11069539|NCT01408862|OG000|Outcome|Controls|Flow cytometry studies In order to test the presence of GLP1 and GIP receptors on normal platelet membrane, indirect immunodetection was carried out in platelet samples from 20 normal donors.
11069540|NCT01408862|OG000|Outcome|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
11069541|NCT01408862|EG000|Reported Event|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
11069542|NCT01408888|BG000|Baseline|Entire Study Population|Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).
11069543|NCT01408888|FG000|Participant Flow|LY2189265, Sitagliptin + LY2189265|"First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).~Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).~There was a washout of at least 21 days between treatments."
11069544|NCT01408888|FG001|Participant Flow|Sitagliptin + LY2189265, LY2189265|"First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).~Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).~There was a washout of at least 21 days between treatments."
11069545|NCT01408888|OG000|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
11069546|NCT01408888|OG001|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
11069547|NCT01408888|OG002|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
11069548|NCT01408888|OG001|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg of LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
11069549|NCT01408888|OG000|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
11069550|NCT01408888|OG001|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
11069551|NCT01408888|OG002|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
11069552|NCT01408888|OG000|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
11069553|NCT01408888|OG001|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
11173502|NCT02015819|OG000|Outcome|Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. They will also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11069554|NCT01408888|OG002|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
11069555|NCT01408888|OG000|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
11069556|NCT01408888|EG000|Reported Event|LY2189265|"LY2189265: a single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously on Day 1 of Treatment 1~Time frame: Treatment 1"
11069557|NCT01408888|EG001|Reported Event|Sitagliptin|"Sitagliptin: 100-mg dose of sitagliptin, administered orally, once daily before the LY2189265 dose on Day 1 to Day 5 of Treatment 2.~Time Frame: Day 1 to Day 5 of Treatment 2"
11069558|NCT01408888|EG002|Reported Event|Sitagliptin + LY2189265|"Sitagliptin + LY2189265: 100-mg dose of sitagliptin administered orally, once daily from Day 5 to Day 18 of Treatment 2 in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 of Treatment 2.~Time Frame: Day 5 to end of Treatment 2"
11069559|NCT01408901|BG000|Baseline|A: GM-CSF + Supervised Treadmill Exercise Therapy|"Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.~granulocyte macrophage colony stimulating factor (GM-CSF): The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks."
11069560|NCT01408901|BG001|Baseline|B: GM-CSF + Attention Control Group|"Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.~granulocyte macrophage colony stimulating factor (GM-CSF): The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks."
11069561|NCT01408901|BG002|Baseline|C: Placebo + Supervised Exercise Therapy|Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.
11069562|NCT01408901|BG003|Baseline|D: Placebo + Attention Control Group|Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.
11069563|NCT01408901|BG004|Baseline|Total|Total of all reporting groups
11069564|NCT01408901|FG000|Participant Flow|A: GM-CSF + Supervised Treadmill Exercise Therapy|"Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.~granulocyte macrophage colony stimulating factor (GM-CSF): The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks."
11069565|NCT01408901|FG001|Participant Flow|B: GM-CSF + Attention Control Group|"Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.~granulocyte macrophage colony stimulating factor (GM-CSF): The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks."
11150231|NCT01876485|BG001|Baseline|Arm 2: Enhanced Usual Care (EUC)|"The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.~Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility."
10887608|NCT00501631|EG001|Reported Event|Placebo for VIVITROL 380 mg (Double-blind Period)|
11069566|NCT01408901|FG002|Participant Flow|C: Placebo + Supervised Exercise Therapy|Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.
11069567|NCT01408901|FG003|Participant Flow|D: Placebo + Attention Control Group|Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.
11069568|NCT01408901|OG000|Outcome|A: GM-CSF + Supervised Treadmill Exercise Therapy|"Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.~granulocyte macrophage colony stimulating factor (GM-CSF): The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks."
11069569|NCT01408901|OG001|Outcome|B: GM-CSF + Attention Control Group|"Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.~granulocyte macrophage colony stimulating factor (GM-CSF): The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks."
11069570|NCT01408901|OG002|Outcome|C: Placebo + Supervised Exercise Therapy|Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.
10887609|NCT00501644|BG000|Baseline|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
10887610|NCT00501644|FG000|Participant Flow|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
11150232|NCT01876485|BG002|Baseline|Total|Total of all reporting groups
11150233|NCT01876485|FG000|Participant Flow|Arm 1: Empowering Patients in Chronic Care (EPIC)|"Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.~Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans."
11150234|NCT01876485|FG001|Participant Flow|Arm 2: Enhanced Usual Care (EUC)|"The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the Patient Aligned Care Team (PACT) Registered Nurse (RN) Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.~Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility."
11150235|NCT01876485|OG000|Outcome|Arm 1: Empowering Patients in Chronic Care (EPIC)|"Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.~Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans."
11069571|NCT01408901|OG003|Outcome|D: Placebo + Attention Control Group|Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.
11069572|NCT01408901|OG000|Outcome|C: Placebo + Supervised Exercise Therapy|Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.
11069573|NCT01408901|OG001|Outcome|D: Placebo + Attention Control Group|Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.
11069574|NCT01408901|EG000|Reported Event|A: GM-CSF + Supervised Treadmill Exercise Therapy|"Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.~granulocyte macrophage colony stimulating factor (GM-CSF): The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks."
11069575|NCT01408901|EG001|Reported Event|B: GM-CSF + Attention Control Group|"Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.~granulocyte macrophage colony stimulating factor (GM-CSF): The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks."
11069576|NCT01408901|EG002|Reported Event|C: Placebo + Supervised Exercise Therapy|Supervised Treadmill Exercise Therapy: Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.
11069577|NCT01408901|EG003|Reported Event|D: Placebo + Attention Control Group|Health education sessions (Control): Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.
11069578|NCT01408914|BG000|Baseline|10 mg/kg|10 mg/kg RIF
11069579|NCT01408914|BG001|Baseline|15 mg/kg|15 mg/kg RIF
11069580|NCT01408914|BG002|Baseline|20 mg/kg|20 mg/kg RIF
11069581|NCT01408914|BG003|Baseline|Total|Total of all reporting groups
10887611|NCT00501644|OG000|Outcome|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
11069582|NCT01408914|FG000|Participant Flow|10 mg/kg|10 mg/kg RIF
11069583|NCT01408914|FG001|Participant Flow|15 mg/kg|15 mg/kg RIF
11069584|NCT01408914|FG002|Participant Flow|20 mg/kg|20 mg/kg RIF
11069585|NCT01408914|OG000|Outcome|10 mg/kg|10 mg/kg RIF
11069586|NCT01408914|OG001|Outcome|15 mg/kg|15 mg/kg RIF
11069587|NCT01408914|OG002|Outcome|20 mg/kg|20 mg/kg RIF
11069588|NCT01408914|EG000|Reported Event|10 mg/kg|10 mg/kg RIF
11069589|NCT01408914|EG001|Reported Event|15 mg/kg|15 mg/kg RIF
11069590|NCT01408914|EG002|Reported Event|20 mg/kg|20 mg/kg RIF
11069591|NCT01408992|BG000|Baseline|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. A total of 551 subjects were required to obtain an 80% sensitivity rate for the original test, at a 95% confidence level, with 80% power, and a 7% margin of error. Considering 22.7% as the estimated prevalence of hearing loss [Prasansuk, 2000] and a 10% drop out rate, the total number of subjects needed was 606. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older
11173503|NCT02015819|EG000|Reported Event|Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11069592|NCT01408992|FG000|Participant Flow|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. This district comprises 114 villages and has a population of 24,201 inhabitants. Of these, 13,001 inhabitants lived in municipal areas, whereas the rest lived in non-municipal areas. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older than 18 years, could read or understand the Thai language, and wanted to participate, were recruited. Those who had aphasia, severe mental disability, or other conditions that precluded audiometry were excluded.
11069593|NCT01408992|OG000|Outcome|Normal Ears and Hearing|Normal ear examination and normal hearing
11069594|NCT01408992|OG001|Outcome|Ear Wax|Impacted cerumen
11069595|NCT01408992|OG002|Outcome|Otitis Media With Effusion|Fluid in middle ear, whether serous, mucoid, mucous, or pus
11069596|NCT01408992|OG003|Outcome|Chronic Otitis Media|Tympanic membrane perforation with or without ear discharge
11069597|NCT01408992|OG004|Outcome|Conductive Hearing Loss|Air-bone gap and bone conduction thresholds are lower than 25 dB
11069598|NCT01408992|OG005|Outcome|Sensorineural Hearing Loss|Air and bone conduction thresholds are more than 25 dB
11069599|NCT01408992|OG006|Outcome|Mixed Hearing Loss|Air and bone conduction threshold are more than 25 dB with air-bone gap
11069600|NCT01408992|OG000|Outcome|FMHT|"FMHT Score is the sum of value of the answers for each question. If the subject answers never, it will be scored as 0, occasionally will be 1, half the time will be 2, and almost always will be 3."
11069601|NCT01408992|OG000|Outcome|Hearing Loss|The severity of hearing loss was defined by the pure tone average air-conduction threshold at the speech frequencies of the better hearing ears, according to the ASHA criteria. Normal hearing means PTA of less than or equal 25 dB. Mild hearing loss means PTA of 26-40 dB. Moderate hearing loss means PTA of 41-55 dB. Moderately severe hearing loss means PTA of 56-74 dB. Severe hearing loss means PTA of 75-90 dB. Profound hearing loss means PTA > 90 dB.
11069602|NCT01408992|EG000|Reported Event|Community People|All people who live in the Phu Wieng district in Khon Kaen Province was chosen as a representative of community people in Thailand.
11069603|NCT01409096|BG000|Baseline|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
11069604|NCT01409096|BG001|Baseline|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
11069605|NCT01409096|BG002|Baseline|Total|Total of all reporting groups
11069606|NCT01409096|FG000|Participant Flow|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
11069607|NCT01409096|FG001|Participant Flow|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
11069608|NCT01409096|OG000|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
11069609|NCT01409096|OG001|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
11069610|NCT01409096|EG000|Reported Event|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
11069611|NCT01409096|EG001|Reported Event|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
11069612|NCT01409213|BG000|Baseline|All Enrolled Participants|Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
11069613|NCT01409213|FG000|Participant Flow|All Enrolled Participants|
11069614|NCT01409213|OG000|Outcome|All Enrolled Participants|All enrolled participants with available data.
11069615|NCT01409213|EG000|Reported Event|All Enrolled Participants|
11069616|NCT01409239|BG000|Baseline|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
11069617|NCT01409239|BG001|Baseline|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
11069618|NCT01409239|BG002|Baseline|Total|Total of all reporting groups
11069619|NCT01409239|FG000|Participant Flow|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
11226929|NCT02378935|BG001|Baseline|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
11069620|NCT01409239|FG001|Participant Flow|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
11069621|NCT01409239|OG000|Outcome|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
11069622|NCT01409239|OG001|Outcome|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
11069623|NCT01409239|EG000|Reported Event|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
11069624|NCT01409239|EG001|Reported Event|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
11069625|NCT01409291|BG000|Baseline|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
11069626|NCT01409291|BG001|Baseline|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
11069627|NCT01409291|BG002|Baseline|Total|Total of all reporting groups
11069628|NCT01409291|FG000|Participant Flow|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
11069629|NCT01409291|FG001|Participant Flow|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
11069630|NCT01409291|OG000|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
11069631|NCT01409291|OG001|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
11069632|NCT01409291|EG000|Reported Event|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
11069633|NCT01409291|EG001|Reported Event|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
11069634|NCT01409382|BG000|Baseline|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
11069635|NCT01409382|BG001|Baseline|Standard Follow-up|Prenatal care will proceed according to the routine
11069636|NCT01409382|BG002|Baseline|Total|Total of all reporting groups
11069637|NCT01409382|FG000|Participant Flow|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet. Patients assigned to the intervention protocol will be instructed to walk briskly for at least 40 minutes seven days a week, to avoid high-carbohydrate meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
11069638|NCT01409382|FG001|Participant Flow|Standard Follow-up|Prenatal care will proceed according to the routine. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
11069639|NCT01409382|OG000|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
11069640|NCT01409382|OG001|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
11069641|NCT01409382|OG000|Outcome|Neonates Born to Mothers Assigned to Protocol Walking+Diet|Neonates with hypoglycemia (blood glucose levels ≤ 40 mg/dL) at 1, 2 or 4 hours after birth
11069642|NCT01409382|OG001|Outcome|Neonates Born to Controls|Neonates with hypoglycemia detected 1, 2 or 4 hours after birth
11069643|NCT01409382|EG000|Reported Event|Standard Follow-up (Mothers)|Prenatal care will proceed according to the routine.
11069644|NCT01409382|EG001|Reported Event|Lifestyle Counseling (Mothers)|Exercise plus a carbohydrate-controlled diet.
11069645|NCT01409382|EG002|Reported Event|Standard Follow-up (Babies)|Prenatal care will proceed according to the routine.
11069646|NCT01409382|EG003|Reported Event|Lifestyle Counseling (Babies)|Exercise plus a carbohydrate-controlled diet.
11069647|NCT01409434|BG000|Baseline|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
11069648|NCT01409434|FG000|Participant Flow|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
11069649|NCT01409434|OG000|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
11069650|NCT01409434|EG000|Reported Event|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
11069651|NCT01409564|BG000|Baseline|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
11069652|NCT01409564|BG001|Baseline|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
11069653|NCT01409564|BG002|Baseline|Total|Total of all reporting groups
11069654|NCT01409564|FG000|Participant Flow|Cilostazol|Cilostazol group includes dementia patients receiving donepezil with cilostazol augmentation. All the randomly assigned AD patients in cilostazol group received 10 mg of Donepezil along with 200 mg of cilostazol per a day, doubly blinded. All the medications were orally administered. For the initial two weeks, patients only received 100 mg of cilstazol per a day to minimize the instabilities. Afterwards, for 22 weeks, patients received 200 mg of cilostazol.
11069655|NCT01409564|FG001|Participant Flow|Placebo|Placebo group includes dementia patients receiving donepezil with placebo. All the patients were randomly assigned as placebo group and received 10 mg of Donepezil along with the same dose of sugar pill as normal cilostazol. All the clinical assessments and medications were doubly blinded. All the medications were orally administered.
11069656|NCT01409564|OG000|Outcome|Cilostazol, Baseline|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation at the baseline.
11069657|NCT01409564|OG001|Outcome|Cilostazol, 24-week|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation after 24 weeks.
11069658|NCT01409564|OG002|Outcome|Placebo, Baseline|Placebo group means dementia patients group receiving donepezil with placebo at the baseline.
11069659|NCT01409564|OG003|Outcome|Placebo, 24-week|Placebo group means dementia patients group receiving donepezil with placebo after 24 weeks.
11069660|NCT01409564|OG000|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
11069661|NCT01409564|OG001|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
11069662|NCT01409564|EG000|Reported Event|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
11069663|NCT01409564|EG001|Reported Event|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
11069664|NCT01409707|BG000|Baseline|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
11069665|NCT01409707|BG001|Baseline|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
11069666|NCT01409707|BG002|Baseline|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
11069667|NCT01409707|BG003|Baseline|Total|Total of all reporting groups
11069668|NCT01409707|FG000|Participant Flow|Healthy Lifestyles Sessions|Healthy lifestyles sessions is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
11069669|NCT01409707|FG001|Participant Flow|Trauma-focused Exposure Therapy|Trauma-focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma-focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
11069670|NCT01409707|FG002|Participant Flow|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting exposure therapy. Exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided.
11069671|NCT01409707|OG000|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
11069672|NCT01409707|OG001|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
11173504|NCT02015819|EG001|Reported Event|Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11069673|NCT01409707|OG002|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
11069674|NCT01409707|EG000|Reported Event|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
11069675|NCT01409707|EG001|Reported Event|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
11069676|NCT01409811|BG000|Baseline|Treatment (Zoledronic Acid)|"Patients receive a single dose of zoledronic acid 4 mg IV over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis.~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo definitive lumpectomy or mastectomy"
11069677|NCT01409811|FG000|Participant Flow|Treatment (Zoledronic Acid)|"Patients receive a single dose of zoledronic acid 4 mg IV over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis.~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo definitive lumpectomy or mastectomy"
11069678|NCT01409811|OG000|Outcome|Treatment (Zoledronic Acid)|"Patients receive a single dose of zoledronic acid 4 mg IV over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis.~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo definitive lumpectomy or mastectomy"
11069679|NCT01409811|EG000|Reported Event|Treatment (Zoledronic Acid)|"Patients receive a single dose of zoledronic acid 4 mg IV over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis.~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo definitive lumpectomy or mastectomy"
11069680|NCT01409837|BG000|Baseline|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
11069681|NCT01409837|BG001|Baseline|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
11069682|NCT01409837|BG002|Baseline|Total|Total of all reporting groups
11069683|NCT01409837|FG000|Participant Flow|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril 2.5 mg taken once a day. Then crossed over to Sugar Pill taken also once a day. The Lisinopril and the Sugar Pill were made indistinguishable in appearance.
11069684|NCT01409837|FG001|Participant Flow|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill taken once daily. Then crossed over to Lisinopril 2.5 mg taken once a day.
11069685|NCT01409837|OG000|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
11226930|NCT02378935|BG002|Baseline|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
11069686|NCT01409837|OG001|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
11226931|NCT02378935|BG003|Baseline|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
11069687|NCT01409837|OG000|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
11069688|NCT01409837|OG001|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
11069689|NCT01409837|EG000|Reported Event|Events Reported During Treatment With Lisinopril|All the events reported by patients in either group A or group B while receiving Lisinopril.
11069690|NCT01409837|EG001|Reported Event|Events Reported During Treatment With Placebo|All the events reported by patients in either group A or group B while receiving the Sugar Pill.
11069691|NCT01409915|BG000|Baseline|Sagramostim (Leukine)|250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
11069692|NCT01409915|BG001|Baseline|Control Group|Saline placebo comparator: subcutaneous injection
11069693|NCT01409915|BG002|Baseline|Total|Total of all reporting groups
11069694|NCT01409915|FG000|Participant Flow|Sagramostim (Leukine)|250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
11069695|NCT01409915|FG001|Participant Flow|Control Group|Saline placebo comparator: subcutaneous injection
11069696|NCT01409915|OG000|Outcome|Sagramostim (Leukine)|250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
11069697|NCT01409915|OG001|Outcome|Control Group|Saline placebo comparator: subcutaneous injection
11069698|NCT01409915|EG000|Reported Event|Sagramostim (Leukine)|250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
11069699|NCT01409915|EG001|Reported Event|Control Group|Saline placebo comparator: subcutaneous injection
11069700|NCT01409928|BG000|Baseline|Lap-Band|"Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure.~LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity."
11069701|NCT01409928|FG000|Participant Flow|Lap-Band|"Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure.~LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity."
11069702|NCT01409928|OG000|Outcome|Lap-Band|"Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure.~LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity."
11069703|NCT01409928|EG000|Reported Event|Lap-Band|"Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure.~LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity."
11069704|NCT01409993|BG000|Baseline|Sildenafil|"sildenafil 25 mg p.o. tid~Administration of sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069705|NCT01409993|BG001|Baseline|Placebo|"matching placebo p.o. tid~Administration of placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil or placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069706|NCT01409993|BG002|Baseline|Total|Total of all reporting groups
11069707|NCT01409993|FG000|Participant Flow|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069708|NCT01409993|FG001|Participant Flow|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11226932|NCT02378935|BG004|Baseline|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
11069709|NCT01409993|FG002|Participant Flow|Sildenafil Aim 2|Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive sildenafil for 3 months. Another euglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test.
11069710|NCT01409993|FG003|Participant Flow|Placebo Aim 2|Administration of Placebo: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
11226933|NCT02378935|BG005|Baseline|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
11357467|NCT03757234|OG004|Outcome|Levofloxacin 750 iv/750 po or iv|On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
11069711|NCT01409993|OG000|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069712|NCT01409993|OG001|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069713|NCT01409993|OG000|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid~Administration of Sildenafil : Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069714|NCT01409993|OG001|Outcome|Placebo Aim 2|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069715|NCT01409993|OG000|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil : Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069716|NCT01409993|OG001|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069717|NCT01409993|OG002|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid~Sildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069718|NCT01409993|OG003|Outcome|Placebo Aim 2|"matching placebo p.o. tid~Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069719|NCT01409993|OG000|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069720|NCT01409993|OG001|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069721|NCT01409993|EG000|Reported Event|Sildenafil - Aims 1 and 2|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
10887612|NCT00501644|EG000|Reported Event|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
11069722|NCT01409993|EG001|Reported Event|Placebo - Aims 1 and 2|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
11069723|NCT01410058|BG000|Baseline|Nevirapine|"HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder~Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules"
11069724|NCT01410058|BG001|Baseline|Efavirenz|"HIV positive patients on efavirenz containing regimen, taking Moringa oleifera~Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules"
11069725|NCT01410058|BG002|Baseline|Total|Total of all reporting groups
11069726|NCT01410058|FG000|Participant Flow|Nevirapine|HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
11069727|NCT01410058|FG001|Participant Flow|Efavirenz|HIV positive patients on efavirenz containing regimen, taking Moringa oleifera leaf powder
11069728|NCT01410058|OG000|Outcome|Nevirapine|"HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder~Moringa oleifera: leaf powder"
11069729|NCT01410058|OG001|Outcome|Efavirenz|"HIV positive patients on efavirenz containing regimen, taking Moringa oleifera~Moringa oleifera: leaf powder"
11069730|NCT01410058|OG000|Outcome|Nevirapine|"HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder~Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules"
11069731|NCT01410058|OG001|Outcome|Efavirenz|"HIV positive patients on efavirenz containing regimen, taking Moringa oleifera~Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules"
11069732|NCT01410058|EG000|Reported Event|Nevirapine|"HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder~Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules"
11069733|NCT01410058|EG001|Reported Event|Efavirenz|"HIV positive patients on efavirenz containing regimen, taking Moringa oleifera~Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules"
11069734|NCT01410084|BG000|Baseline|Vitamin D3|"100,000 IU vitamin D3 once monthly~Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months"
11069735|NCT01410084|BG001|Baseline|Vitamin E|"400 IU vitamin E once monthly~Vitamin E: 400 IU vitamin E once monthly for 5 months"
11069736|NCT01410084|BG002|Baseline|Total|Total of all reporting groups
11069737|NCT01410084|FG000|Participant Flow|Vitamin D3|"100,000 IU vitamin D3 once monthly~Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months"
11069738|NCT01410084|FG001|Participant Flow|Vitamin E|"400 IU vitamin E once monthly~Vitamin E: 400 IU vitamin E once monthly for 5 months"
10887613|NCT00501852|BG000|Baseline|Overall Study|
11069739|NCT01410084|OG000|Outcome|Vitamin D3|"100,000 IU vitamin D3 once monthly~Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months"
11069740|NCT01410084|OG001|Outcome|Vitamin E|"400 IU vitamin E once monthly~Vitamin E: 400 IU vitamin E once monthly for 5 months"
11069741|NCT01410084|EG000|Reported Event|Vitamin D3|"100,000 IU vitamin D3 once monthly~Vitamin D3: 100,000 IU vitamin D3 once monthly for 5 months"
11069742|NCT01410084|EG001|Reported Event|Vitamin E|"400 IU vitamin E once monthly~Vitamin E: 400 IU vitamin E once monthly for 5 months"
11069743|NCT01410097|BG000|Baseline|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
11069744|NCT01410097|BG001|Baseline|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
11069745|NCT01410097|BG002|Baseline|Total|Total of all reporting groups
11069746|NCT01410097|FG000|Participant Flow|Lifestyle Intervention|"Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.~Lifestyle intervention: Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight."
11069747|NCT01410097|FG001|Participant Flow|Diabetes Support and Education (DSE)|"It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.~Diabetes Support Education: It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial."
11069748|NCT01410097|OG000|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
11069749|NCT01410097|OG001|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
11069750|NCT01410097|EG000|Reported Event|Lifestyle Intervention|"Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.~Lifestyle intervention: Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight."
11069751|NCT01410097|EG001|Reported Event|Diabetes Support and Education (DSE)|"It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.~Diabetes Support Education: It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial."
11069752|NCT01410110|BG000|Baseline|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
11069753|NCT01410110|BG001|Baseline|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
11069754|NCT01410110|BG002|Baseline|Total|Total of all reporting groups
11069755|NCT01410110|FG000|Participant Flow|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
11069756|NCT01410110|FG001|Participant Flow|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
11069757|NCT01410110|OG000|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
11069758|NCT01410110|OG001|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
11069759|NCT01410110|EG000|Reported Event|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
11069760|NCT01410110|EG001|Reported Event|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
11069761|NCT01410227|BG000|Baseline|All Subjects Treated With Study Product|All subjects treated with study product
11069762|NCT01410227|FG000|Participant Flow|Arm 1: PK50 + Treatment|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
10887614|NCT00501852|FG000|Participant Flow|Overall Study|
11069763|NCT01410227|FG001|Participant Flow|Arm 2: PK50 Only|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). Participants then exited the study or could opt to sign informed consent to move to Arm 1 receive treatment for bleeding episodes with study product.
11069764|NCT01410227|FG002|Participant Flow|Arm 3: PK80 + Treatment|In Part A, participants initially underwent a first PK assessment of an infusion of 80 IU/kg recombinant von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF]. After the first PK assessment participants received on demand treatment for bleeding episodes (BEs) with study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rWVF with or without rFVIII, based on FVIII levels. If FVIII levels not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. After 6 months participants underwent a second PK assessment of an infusion of 80 IU/kg rVWF. In part B, participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
11069765|NCT01410227|FG003|Participant Flow|Arm 4: Treatment Only|In Part A, participants received on-demand treatment for bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] administered together with recombinant Factor VIII [rFVIII] (rVWF:rFVIII) or rVWF alone), where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels. If not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months. No pharmacokinetic (PK) assessments were conducted in this arm.
11069766|NCT01410227|OG000|Outcome|Full Analysis Set|Comprises of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
11069767|NCT01410227|OG000|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
11069768|NCT01410227|OG000|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
11069769|NCT01410227|OG000|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total of participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
11069770|NCT01410227|OG000|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
11069771|NCT01410227|OG000|Outcome|Overall Study Arm|
11069772|NCT01410227|OG000|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
11069773|NCT01410227|EG000|Reported Event|Safety Analysis Set|Comprises of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
11069774|NCT01410240|BG000|Baseline|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
11069775|NCT01410240|BG001|Baseline|FLOSEAL + Standard of Care (SoC) - Non-Run-In|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
11069776|NCT01410240|BG002|Baseline|FLOSEAL + Standard of Care (SoC) - Run-In|"Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.~FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
11069777|NCT01410240|BG003|Baseline|Total|Total of all reporting groups
11069778|NCT01410240|FG000|Participant Flow|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
11069779|NCT01410240|FG001|Participant Flow|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
11069780|NCT01410240|FG002|Participant Flow|FLOSEAL + Standard of Care (SoC) Run-In Participants|"This arm/group only includes the 12 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures and the use of FLOSEAL)~FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
11069781|NCT01410240|OG000|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
11069782|NCT01410240|OG001|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
11069783|NCT01410240|OG000|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
11069784|NCT01410240|OG001|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
11069785|NCT01410240|OG000|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
11069786|NCT01410240|EG000|Reported Event|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
11069787|NCT01410240|EG001|Reported Event|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
11069788|NCT01410344|BG000|Baseline|Allogeneic Transplant|One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
11069789|NCT01410344|FG000|Participant Flow|Allogeneic Transplant|One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
11069790|NCT01410344|OG000|Outcome|Allogeneic Transplant|One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
11069791|NCT01410344|OG000|Outcome|Myeloablative Allogeneic Transplant|Myeloablative conditioning (MAC) (Busulfan and Fludarabine or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
11069792|NCT01410344|OG001|Outcome|Reduced Intensity Allogeneic Transplant|Reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
11069793|NCT01410344|EG000|Reported Event|Allogeneic Transplant|One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
11069794|NCT01410357|BG000|Baseline|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
11069795|NCT01410357|BG001|Baseline|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
11069796|NCT01410357|BG002|Baseline|Total|Total of all reporting groups
11069797|NCT01410357|FG000|Participant Flow|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM (diabetes mellitus) and SMI (serious mental illness) from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
11069798|NCT01410357|FG001|Participant Flow|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
11173505|NCT02015819|EG002|Reported Event|Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11173506|NCT02015819|EG003|Reported Event|Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. They will also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11173507|NCT02016105|BG000|Baseline|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
11069799|NCT01410357|OG000|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
11069800|NCT01410357|OG001|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
11069801|NCT01410357|OG000|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm will receive the TTIM intervention as well as receiving regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blends psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, has been adapted to the primary care setting and targeted for SMI-DM participants. Generalizability is enhanced with relatively brief in-person participation requirements and by utilizing professional staff typically found in primary care. TTIM will stress information sharing that is accessible to participants, and through a collaborative process, foster motivation for SMI-DM self-management."
11069802|NCT01410357|OG001|Outcome|Treatment As Usual (TAU)|Participants in this arm will continue to receive Treatment as Usual from their usual medical and mental health care providers. They will not receive any intervention.
11069803|NCT01410357|EG000|Reported Event|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
11069804|NCT01410357|EG001|Reported Event|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
11069805|NCT01410409|BG000|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
11069806|NCT01410409|BG001|Baseline|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
11069807|NCT01410409|BG002|Baseline|Total|Total of all reporting groups
11069808|NCT01410409|FG000|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
11069809|NCT01410409|FG001|Participant Flow|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
11226934|NCT02378935|BG006|Baseline|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
11226935|NCT02378935|BG007|Baseline|Total|Total of all reporting groups
11069810|NCT01410409|OG000|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
11069811|NCT01410409|OG001|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
11069812|NCT01410409|EG000|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
11069813|NCT01410409|EG001|Reported Event|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
11069814|NCT01410448|BG000|Baseline|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
11069815|NCT01410448|BG001|Baseline|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
11069816|NCT01410448|BG002|Baseline|Total|Total of all reporting groups
11069817|NCT01410448|FG000|Participant Flow|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
11069818|NCT01410448|FG001|Participant Flow|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
11069819|NCT01410448|OG000|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
11069820|NCT01410448|OG001|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
11069821|NCT01410448|EG000|Reported Event|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
11069822|NCT01410448|EG001|Reported Event|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
11069823|NCT01410474|BG000|Baseline|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
10887615|NCT00501852|OG000|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11069824|NCT01410474|BG001|Baseline|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069825|NCT01410474|BG002|Baseline|Total|Total of all reporting groups
11069826|NCT01410474|FG000|Participant Flow|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
10887616|NCT00501852|OG001|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11226936|NCT02378935|FG000|Participant Flow|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
11226937|NCT02378935|FG001|Participant Flow|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants without cirrhosis
11226938|NCT02378935|FG002|Participant Flow|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
11226939|NCT02378935|FG003|Participant Flow|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
11226940|NCT02378935|FG004|Participant Flow|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in direct-acting antiviral (DAA) experienced participants without cirrhosis
11226941|NCT02378935|FG005|Participant Flow|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
11226942|NCT02378935|FG006|Participant Flow|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
11226943|NCT02378935|OG000|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
11226944|NCT02378935|OG001|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
11226945|NCT02378935|OG002|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
11226946|NCT02378935|OG003|Outcome|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
11226947|NCT02378935|OG004|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
11226948|NCT02378935|OG005|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
11226949|NCT02378935|OG006|Outcome|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
11226950|NCT02378935|EG000|Reported Event|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
11226951|NCT02378935|EG001|Reported Event|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
11226952|NCT02378935|EG002|Reported Event|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
11226953|NCT02378935|EG003|Reported Event|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
10887617|NCT00501852|OG002|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11226954|NCT02378935|EG004|Reported Event|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
11226955|NCT02378935|EG005|Reported Event|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
11226956|NCT02378935|EG006|Reported Event|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
11226957|NCT02378961|BG000|Baseline|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
10887618|NCT00501852|OG003|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11226958|NCT02378961|BG001|Baseline|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
11226959|NCT02378961|BG002|Baseline|VOX+SOF/VEL 12 Weeks, Treatment-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
11226960|NCT02378961|BG003|Baseline|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
11226961|NCT02378961|BG004|Baseline|Total|Total of all reporting groups
11226962|NCT02378961|FG000|Participant Flow|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
11069827|NCT01410474|FG001|Participant Flow|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069828|NCT01410474|OG000|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069829|NCT01410474|OG000|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069830|NCT01410474|OG001|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069831|NCT01410474|OG002|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069832|NCT01410474|OG000|Outcome|2-5 Years|Subjects 2-5 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
11069833|NCT01410474|OG000|Outcome|6-10 Years|Subjects 6-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
11069834|NCT01410474|OG001|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
11069835|NCT01410474|OG002|Outcome|Overall (6-18 Years)|Subjects 6-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
11069836|NCT01410474|EG000|Reported Event|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069837|NCT01410474|EG001|Reported Event|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069838|NCT01410474|EG002|Reported Event|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11069839|NCT01410552|BG000|Baseline|Single Arm|ICD or CRT-D with PARAD+
11069840|NCT01410552|FG000|Participant Flow|ICD or CRT-D With PARAD+|"only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator~PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770: PARADYM ICD and CRT-d with PARAD+ algorithm available"
11069841|NCT01410552|OG000|Outcome|Single Arm|ICD or CRT-D with PARAD+
11069842|NCT01410552|EG000|Reported Event|ICD or CRT-D With PARAD+|"only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator~PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770: PARADYM ICD and CRT-d with PARAD+ algorithm available"
11069843|NCT01410565|BG000|Baseline|Apaziquone|"Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
11069844|NCT01410565|BG001|Baseline|Placebo|"Placebo~Placebo in the Double Blind Phase"
11069845|NCT01410565|BG002|Baseline|Total|Total of all reporting groups
11069846|NCT01410565|FG000|Participant Flow|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone: Apaziquone in the Double Blind Phase"
11069847|NCT01410565|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo in the Double Blind Phase"
11069848|NCT01410565|FG002|Participant Flow|Open Label-Apaziquone|
11069849|NCT01410565|OG000|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
11069850|NCT01410565|OG001|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
11069851|NCT01410565|EG000|Reported Event|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone: Apaziquone in the Double Blind Phase"
11069852|NCT01410565|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo in the Double Blind Phase"
11069853|NCT01410604|BG000|Baseline|Metformin|
11069854|NCT01410604|BG001|Baseline|Placebo|
11069855|NCT01410604|BG002|Baseline|Total|Total of all reporting groups
11069856|NCT01410604|FG000|Participant Flow|Metformin|
11069857|NCT01410604|FG001|Participant Flow|Placebo|
11069858|NCT01410604|OG000|Outcome|Metformin|
11069859|NCT01410604|OG001|Outcome|Placebo|
11069860|NCT01410604|EG000|Reported Event|Metformin|
11069861|NCT01410604|EG001|Reported Event|Placebo|
11069862|NCT01410773|BG000|Baseline|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
11069863|NCT01410773|FG000|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
11069864|NCT01410773|OG000|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
11069865|NCT01410773|EG000|Reported Event|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
11069866|NCT01410812|BG000|Baseline|Suggested Tying|"Receive same treatments as control group, but instead of receiving cash they receive 4 iTunes audio novels for their own iPods. Further, they are prompted to try to listen to those novels only when exercising at the gym in order to increase their attendance.~Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym"
11173508|NCT02016105|BG001|Baseline|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
11069867|NCT01410812|BG001|Baseline|Forced Tying|"Receives same treatment as the control group. However, in addition to receiving the cash, they also receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym. They are told they may only listen to these novels only when at the gym in order to increase their attendance.~Forced Tying Intervention: Participants receive cash and also 4 iTunes audio novels for a loaned iPod accessible only at the gym to listen to only at the gym."
11069868|NCT01410812|BG002|Baseline|Control|"Control group of participants who do not receive any intervention but are weighed at the beginning and end of a 10 week period and receive weekly emails asking them about their exercise. They also receive the equivalent cash value of 4 iTunes audio novels~Control: Receive weekly emails asking participants about their exercise and receive cash."
11069869|NCT01410812|BG003|Baseline|Total|Total of all reporting groups
11069870|NCT01410812|FG000|Participant Flow|Suggested Tying|"Receive same treatments as control group, but instead of receiving cash they receive 4 iTunes audio novels for their own iPods. Further, they are prompted to try to listen to those novels only when exercising at the gym in order to increase their attendance.~Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym"
11069871|NCT01410812|FG001|Participant Flow|Forced Tying|"Receives same treatment as the control group. However, in addition to receiving the cash, they also receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym. They are told they may only listen to these novels only when at the gym in order to increase their attendance.~Forced Tying Intervention: Participants receive cash and also 4 iTunes audio novels for a loaned iPod accessible only at the gym to listen to only at the gym."
11069872|NCT01410812|FG002|Participant Flow|Control|"Control group of participants who do not receive any intervention but are weighed at the beginning and end of a 10 week period and receive weekly emails asking them about their exercise. They also receive the equivalent cash value of 4 iTunes audio novels~Control: Receive weekly emails asking participants about their exercise and receive cash."
11069873|NCT01410812|OG000|Outcome|Suggested Tying|"Receive same treatments as control group, but instead of receiving cash they receive 4 iTunes audio novels for their own iPods. Further, they are prompted to try to listen to those novels only when exercising at the gym in order to increase their attendance.~Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym"
11069874|NCT01410812|OG001|Outcome|Forced Tying|"Receives same treatment as the control group. However, in addition to receiving the cash, they also receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym. They are told they may only listen to these novels only when at the gym in order to increase their attendance.~Forced Tying Intervention: Participants receive cash and also 4 iTunes audio novels for a loaned iPod accessible only at the gym to listen to only at the gym."
11069875|NCT01410812|OG002|Outcome|Control|"Control group of participants who do not receive any intervention but are weighed at the beginning and end of a 10 week period and receive weekly emails asking them about their exercise. They also receive the equivalent cash value of 4 iTunes audio novels~Control: Receive weekly emails asking participants about their exercise and receive cash."
11069876|NCT01410812|EG000|Reported Event|Suggested Tying|"Receive same treatments as control group, but instead of receiving cash they receive 4 iTunes audio novels for their own iPods. Further, they are prompted to try to listen to those novels only when exercising at the gym in order to increase their attendance.~Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym"
11173509|NCT02016105|BG002|Baseline|Total|Total of all reporting groups
11173510|NCT02016105|FG000|Participant Flow|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
11173511|NCT02016105|FG001|Participant Flow|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
11173512|NCT02016105|FG002|Participant Flow|Humira ® Adalimumab Switched|Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).
11173513|NCT02016105|FG003|Participant Flow|Humira ® Adalimumab Continued|Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
11173514|NCT02016105|FG004|Participant Flow|GP2017 Adalimumab Switched|Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).
11173515|NCT02016105|FG005|Participant Flow|GP2017 Adalimumab Continued|GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
11173516|NCT02016105|OG000|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
11173517|NCT02016105|OG001|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
11173518|NCT02016105|OG000|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
11173519|NCT02016105|OG001|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
11069877|NCT01410812|EG001|Reported Event|Forced Tying|"Receives same treatment as the control group. However, in addition to receiving the cash, they also receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym. They are told they may only listen to these novels only when at the gym in order to increase their attendance.~Forced Tying Intervention: Participants receive cash and also 4 iTunes audio novels for a loaned iPod accessible only at the gym to listen to only at the gym."
11069878|NCT01410812|EG002|Reported Event|Control|"Control group of participants who do not receive any intervention but are weighed at the beginning and end of a 10 week period and receive weekly emails asking them about their exercise. They also receive the equivalent cash value of 4 iTunes audio novels~Control: Receive weekly emails asking participants about their exercise and receive cash."
11069879|NCT01411085|BG000|Baseline|Risperidone + Desipramine|All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone or paliperidone palmitate) at the time treatment with desipramine was initiated. The target dose of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
11069880|NCT01411085|FG000|Participant Flow|Risperidone + Desipramine|All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone and paliperidone palmitate) at the time that treatment with desipramine was initiated. The target of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
11069881|NCT01411085|OG000|Outcome|Risperidone + Desipramine|All participants were treated with risperidone (or a risperidone-like agent, including risperidone long-acting, paliperidone or paliperidone palmitate). The target dose of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
11069882|NCT01411085|EG000|Reported Event|Risperidone + Desipramine|"All participants were treated with risperidone (or a risperidone-like agent including: risperidone long-acting, paliperdione, and paliperidone palmitate) at the time treatment with desipramine is initiated. The target dose of oral risperidone is 4mg/day though variations were allowed. The target dose of desipramine was 100mg/day.~Risperidone + Desipramine"
11069883|NCT01411137|BG000|Baseline|All Study Participants|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.~Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study."
11069884|NCT01411137|FG000|Participant Flow|IPX066|extended-release CD-LD
11069885|NCT01411137|OG000|Outcome|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
11069886|NCT01411137|OG001|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
11069887|NCT01411137|OG002|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
11069888|NCT01411137|OG003|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
11069889|NCT01411137|OG000|Outcome|Part 1: Conversion (Baseline)|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
11069890|NCT01411137|OG001|Outcome|Part 1: Conversion (Week 6)|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
11069891|NCT01411137|OG002|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
11069892|NCT01411137|OG003|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
11069893|NCT01411137|OG004|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
11069894|NCT01411137|EG000|Reported Event|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
11069895|NCT01411137|EG001|Reported Event|Part 2: Open-Label Extension 1|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
11069896|NCT01411137|EG002|Reported Event|Part 3: Open-Label Extension 2|Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, a 6-month open-label extension study.
11069897|NCT01411137|EG003|Reported Event|Overall|All treated subjects
11069898|NCT01411215|BG000|Baseline|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
11069899|NCT01411215|BG001|Baseline|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
11069900|NCT01411215|BG002|Baseline|Total|Total of all reporting groups
11069901|NCT01411215|FG000|Participant Flow|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
11069902|NCT01411215|FG001|Participant Flow|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
11069903|NCT01411215|OG000|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
11069904|NCT01411215|OG001|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
11069905|NCT01411215|EG000|Reported Event|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
10887619|NCT00501852|OG004|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11069906|NCT01411215|EG001|Reported Event|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
11069907|NCT01411228|BG000|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11069908|NCT01411228|BG001|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11069909|NCT01411228|BG002|Baseline|Dose Adjusted|Taliglucerase alfa: Dose increased from 30 Units/kg to 45 or 60 Units/kg
11069910|NCT01411228|BG003|Baseline|Total|Total of all reporting groups
11069911|NCT01411228|FG000|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11069912|NCT01411228|FG001|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11069913|NCT01411228|FG002|Participant Flow|Switchover|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11069914|NCT01411228|OG000|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11069915|NCT01411228|OG001|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11069916|NCT01411228|OG002|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
11069917|NCT01411228|EG000|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11226963|NCT02378961|FG001|Participant Flow|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
11069918|NCT01411228|EG001|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
11069919|NCT01411228|EG002|Reported Event|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
11069920|NCT01411319|BG000|Baseline|LEAD Radiation Therapy|"Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.~Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.~Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks."
11069921|NCT01411319|FG000|Participant Flow|LEAD Radiation Therapy|"Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.~Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.~Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks."
11069922|NCT01411319|OG000|Outcome|LEAD Radiation Therapy|"Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.~Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.~Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks."
11069923|NCT01411319|EG000|Reported Event|LEAD Radiation Therapy|"Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.~Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.~Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks."
11069924|NCT01411488|BG000|Baseline|Fecal Management System- Company 1|"41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions~55% male; 60% had history of hemorrhoids"
11069925|NCT01411488|BG001|Baseline|Fecal Management System- Company 2|"38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions~45% male; 39.1% had history of hemorrhoids"
11069926|NCT01411488|BG002|Baseline|Total|Total of all reporting groups
11069927|NCT01411488|FG000|Participant Flow|Fecal Management System- Company 1|"47 adult patients to be randomly assigned to receive a fecal management system by Bard Medical~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions~Note, not all patients were retained"
11069928|NCT01411488|FG001|Participant Flow|Fecal Management System- Company 2|"43 adult patients to be randomly assigned to receive a fecal management system by ConvaTec~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions~Note: not all patients were retained"
11069929|NCT01411488|OG000|Outcome|Fecal Management System- Company 1|"41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions"
11069930|NCT01411488|OG001|Outcome|Fecal Management System- Company 2|"38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions"
11069931|NCT01411488|EG000|Reported Event|Fecal Management System- Company 1|"41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions"
11069932|NCT01411488|EG001|Reported Event|Fecal Management System- Company 2|"38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions"
11069933|NCT01411501|BG000|Baseline|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069934|NCT01411501|BG001|Baseline|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069935|NCT01411501|BG002|Baseline|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069936|NCT01411501|BG003|Baseline|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
11069937|NCT01411501|BG004|Baseline|Total|Total of all reporting groups
11069938|NCT01411501|FG000|Participant Flow|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069939|NCT01411501|FG001|Participant Flow|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069940|NCT01411501|FG002|Participant Flow|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069941|NCT01411501|FG003|Participant Flow|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
11069942|NCT01411501|OG000|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11173520|NCT02016105|OG002|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
10887620|NCT00501852|OG005|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11173521|NCT02016105|OG003|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
11069943|NCT01411501|OG001|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069944|NCT01411501|OG002|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069945|NCT01411501|OG003|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
11069946|NCT01411501|EG000|Reported Event|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069947|NCT01411501|EG001|Reported Event|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
10887621|NCT00501852|EG000|Reported Event|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
10887622|NCT00501852|EG001|Reported Event|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11069948|NCT01411501|EG002|Reported Event|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
11069949|NCT01411501|EG003|Reported Event|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
11069950|NCT01411527|BG000|Baseline|Cross- Sectional Cohort|Schools were randomly selected and 6203 children (50.0 % girls) were invited to participate. 1864 (1097 girls and 767 boys) (age 5.6-20.0 years) were included, resulting in an overall participation-rate of 30%. Blood samples were drawn, and a thorough clinical examination was performed in all participating children
11069951|NCT01411527|BG001|Baseline|Longitudinal Cohort|"209 healthy Danish children (108 girls), were examined and blood samples were drawn every 6 months. In july 2011, the mean (range) number of examinations per child was 7 (2-10).~116 (63 boys and 53 girls) continued from the cross sectional study to the longitudinal study."
11069952|NCT01411527|BG002|Baseline|Total|Total of all reporting groups
11069953|NCT01411527|FG000|Participant Flow|Cross- Sectional Cohort|Schools were randomly selected. Blood samples were drawn, and a thorough clinical examination was performed in all participating children
11069954|NCT01411527|FG001|Participant Flow|Longitudinal Cohort|Healthy Danish children were examined and blood samples were drawn every 6 months.
11069955|NCT01411527|OG000|Outcome|Cross- Sectional Cohort|Schools were randomly selected and 6203 children (50.0 % girls) were invited to participate (overall participation-rate: 30%). Blood samples were drawn, and a thorough clinical examination was performed in all participating children
11069956|NCT01411527|OG001|Outcome|Longitudinal Cohort|209 healthy Danish children (108 girls), were examined and blood samples were drawn every 6 months.
11069957|NCT01411527|EG000|Reported Event|Population|This is a descriptive study elucidating normal variation. Therefore, the study population is not grouped
11173522|NCT02016105|OG000|Outcome|GP2017 Adalimumab|"Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.~GP2017 Adalimumab"
11069958|NCT01411592|BG000|Baseline|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
11069959|NCT01411592|BG001|Baseline|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
11069960|NCT01411592|BG002|Baseline|Total|Total of all reporting groups
11069961|NCT01411592|FG000|Participant Flow|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
11069962|NCT01411592|FG001|Participant Flow|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
11069963|NCT01411592|OG000|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
11069964|NCT01411592|OG001|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
11069965|NCT01411592|EG000|Reported Event|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
11069966|NCT01411592|EG001|Reported Event|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
11069967|NCT01411696|BG000|Baseline|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
11069968|NCT01411696|FG000|Participant Flow|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
11069969|NCT01411696|OG000|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
11069970|NCT01411696|EG000|Reported Event|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
11069971|NCT01411774|BG000|Baseline|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
11069972|NCT01411774|BG001|Baseline|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
11226964|NCT02378961|FG002|Participant Flow|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
11069973|NCT01411774|BG002|Baseline|Total|Total of all reporting groups
11069974|NCT01411774|FG000|Participant Flow|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
11069975|NCT01411774|FG001|Participant Flow|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
11069976|NCT01411774|OG000|Outcome|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
11069977|NCT01411774|OG001|Outcome|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
11069978|NCT01411774|EG000|Reported Event|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
11069979|NCT01411774|EG001|Reported Event|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
11069980|NCT01411839|BG000|Baseline|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
11069981|NCT01411839|BG001|Baseline|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
11069982|NCT01411839|BG002|Baseline|Total|Total of all reporting groups
11069983|NCT01411839|FG000|Participant Flow|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
11069984|NCT01411839|FG001|Participant Flow|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
11069985|NCT01411839|OG000|Outcome|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
11069986|NCT01411839|OG001|Outcome|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
11069987|NCT01411839|EG000|Reported Event|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
11069988|NCT01411839|EG001|Reported Event|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
11069989|NCT01411852|BG000|Baseline|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
11069990|NCT01411852|BG001|Baseline|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
11069991|NCT01411852|BG002|Baseline|Total|Total of all reporting groups
11069992|NCT01411852|FG000|Participant Flow|0.9% Sodium Chloride 2000 mL Bolus|"0.9% Sodium Chloride 2000 mL bolus - An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.~0.9% Sodium Chloride 2000 mL bolus: The systolic blood pressure (SBP) is the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. Once the total fluid reaches 2 liters and the SBP exceeds 110 mmHg, the fluid will be stopped and restarted as necessary to maintain a goal SBP of 110 mmHg."
11069993|NCT01411852|FG001|Participant Flow|0.9% Sodium Chloride 250 mL Bolus|"0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.~0.9% Sodium Chloride 250 mL bolus: Either systolic blood pressure (SBP) or radial pulse is the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients receive 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS is given only to keep the vein open. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first."
11069994|NCT01411852|OG000|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
11069995|NCT01411852|OG001|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
11226965|NCT02378961|FG003|Participant Flow|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
11069996|NCT01411852|OG002|Outcome|ECV Difference [Standard - Controlled]|ECV treatment difference between SR and CR
11069997|NCT01411852|OG001|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
11069998|NCT01411852|EG000|Reported Event|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
11069999|NCT01411852|EG001|Reported Event|Controlled Resuscitation (CR)|"Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.~The total number of patients at risk is one less than the total number of patients enrolled. Regulatory restrictions for prisoners required that no data collection, including severe adverse events, be performed for the patient who was determined to have been in police custody at the time of enrollment."
11070000|NCT01411891|BG000|Baseline|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
11070001|NCT01411891|BG001|Baseline|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
11070002|NCT01411891|BG002|Baseline|Total|Total of all reporting groups
11070003|NCT01411891|FG000|Participant Flow|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
11070004|NCT01411891|FG001|Participant Flow|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
11070005|NCT01411891|OG000|Outcome|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
11226966|NCT02378961|OG000|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
11226967|NCT02378961|OG001|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
11070006|NCT01411891|OG001|Outcome|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
11070007|NCT01411891|EG000|Reported Event|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
11070008|NCT01411891|EG001|Reported Event|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
11070009|NCT01411917|BG000|Baseline|TAP Block Group|"Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.~Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles."
11070010|NCT01411917|BG001|Baseline|Placebo|"Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.~Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles."
11070011|NCT01411917|BG002|Baseline|Total|Total of all reporting groups
11070012|NCT01411917|FG000|Participant Flow|TAP Block Group|"Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.~Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles."
11070013|NCT01411917|FG001|Participant Flow|Placebo|"Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.~Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles."
11070014|NCT01411917|OG000|Outcome|TAP Block Group|"Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.~Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles."
11070015|NCT01411917|OG001|Outcome|Placebo|"Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.~Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles."
11070016|NCT01411917|EG000|Reported Event|TAP Block Group|"Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.~Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles."
11070017|NCT01411917|EG001|Reported Event|Placebo|"Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.~Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles."
11070018|NCT01411995|BG000|Baseline|2% Lidocaine Gel|"Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal~2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
11070019|NCT01411995|BG001|Baseline|Water Based Lubricant|"Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal~Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
11070020|NCT01411995|BG002|Baseline|Total|Total of all reporting groups
11070021|NCT01411995|FG000|Participant Flow|2% Lidocaine Gel|"Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal~2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
11070022|NCT01411995|FG001|Participant Flow|Water Based Lubricant|"Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal~Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
11070023|NCT01411995|OG000|Outcome|2% Lidocaine Gel|"Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal~2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
11070024|NCT01411995|OG001|Outcome|Water Based Lubricant|"Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal~Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
11070025|NCT01411995|EG000|Reported Event|2% Lidocaine Gel|"Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal~2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
11070026|NCT01411995|EG001|Reported Event|Water Based Lubricant|"Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal~Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
11070027|NCT01412021|BG000|Baseline|Humira|Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
11070028|NCT01412021|FG000|Participant Flow|Humira|Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
11070029|NCT01412021|OG000|Outcome|Humira|Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
11070030|NCT01412021|EG000|Reported Event|Humira|Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
11070031|NCT01412060|BG000|Baseline|Cariprazine - Open-label Phase|Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
11070032|NCT01412060|FG000|Participant Flow|Cariprazine - Open-label Phase|Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
11070033|NCT01412060|FG001|Participant Flow|Placebo - Double-blind Treatment Phase|Participants received placebo orally once a day for 26 to 72 weeks.
11070034|NCT01412060|FG002|Participant Flow|Cariprazine - Double-blind Treatment Phase|Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.
11070035|NCT01412060|OG000|Outcome|Placebo|Participants received placebo orally once a day for 26 to 72 weeks. Placebo: Placebo was supplied in capsules.
11070036|NCT01412060|OG001|Outcome|Cariprazine|Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks. Cariprazine: Cariprazine was supplied in capsules.
11070037|NCT01412060|EG000|Reported Event|Cariprazine - Open-label Phase|Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
11349056|NCT04126343|BG000|Baseline|Treatment Sequence: ABC|"Padsevonil (PSL) Treatment Period (Treatment A) participants received PSL 100 milligrams (mg) to 400 mg, orally twice daily (bid) during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon.~Placebo Treatment Period (Treatment B) participants received Placebo matched to PSL Treatment Period doses, bid up to Day 11.~Moxifloxacin (MXF) Treatment Period (Treatment C) participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon.~Participants received PSL, Placebo, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods."
11070038|NCT01412060|EG001|Reported Event|Placebo - Double-blind Treatment Phase|Participants received placebo orally once a day for 26 to 72 weeks.
11070039|NCT01412060|EG002|Reported Event|Cariprazine - Double-blind Treatment Phase|Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.
11070040|NCT01412060|EG003|Reported Event|Open-label - Safety Follow-up Phase|Participants received no treatment during the 4 weeks Safety Follow-up Phase.
11070041|NCT01412060|EG004|Reported Event|Placebo - Safety Follow-up Phase|Participants received no treatment during the 4 weeks Safety Follow-up Phase.
11070042|NCT01412060|EG005|Reported Event|Cariprazine - Safety Follow-up Phase|Participants received no treatment during the 4 weeks Safety Follow-up Phase.
11070043|NCT01412086|BG000|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was received.
11070044|NCT01412086|FG000|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was received.
11070045|NCT01412086|OG000|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
11070046|NCT01412086|EG000|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was received.
11173523|NCT02016105|OG001|Outcome|Humira ® Adalimumab|"Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.~Humira ® Adalimumab"
11070047|NCT01412151|BG000|Baseline|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
11070048|NCT01412151|FG000|Participant Flow|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
11070049|NCT01412151|OG000|Outcome|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
11070050|NCT01412151|OG000|Outcome|Creatine Monohydrate|"Creatine monohydrate: Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose.~Data not analyzed."
11070051|NCT01412151|OG000|Outcome|Creatine Monohydrate|Creatine monohydrate: Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose
11070052|NCT01412151|EG000|Reported Event|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
11070053|NCT01412164|BG000|Baseline|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
11070054|NCT01412164|FG000|Participant Flow|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
11070055|NCT01412164|OG000|Outcome|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
11070056|NCT01412164|EG000|Reported Event|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
11070057|NCT01412229|BG000|Baseline|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
11070058|NCT01412229|FG000|Participant Flow|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin Area under the Curve (AUC2) (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
11070059|NCT01412229|OG000|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
11070060|NCT01412229|OG000|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin area under curve (AUC)2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
11070061|NCT01412229|EG000|Reported Event|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
11070062|NCT01412281|BG000|Baseline|≥18 to ≤60 Years - AdImmune HA Antigen|
11070063|NCT01412281|BG001|Baseline|≥18 to ≤60 Years - CSL HA Antigen|
11070064|NCT01412281|BG002|Baseline|>60 Years - AdImmune HA Antigen|
11070065|NCT01412281|BG003|Baseline|>60 Years - CSL HA Antigen|
11070066|NCT01412281|BG004|Baseline|Total|Total of all reporting groups
11070067|NCT01412281|FG000|Participant Flow|≥18 to ≤60 Years - AdImmune HA Antigen|
11070068|NCT01412281|FG001|Participant Flow|≥18 to ≤60 Years - CSL HA Antigen|
11070069|NCT01412281|FG002|Participant Flow|>60 Years - AdImmune HA Antigen|
11070070|NCT01412281|FG003|Participant Flow|>60 Years - CSL HA Antigen|
11070071|NCT01412281|OG000|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
11070072|NCT01412281|OG001|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
11070073|NCT01412281|OG002|Outcome|>60 Years - AdImmune HA Antigen|
11070074|NCT01412281|OG003|Outcome|>60 Years - CSL HA Antigen|
11070075|NCT01412281|EG000|Reported Event|≥18 to ≤60 Years - AdImmune HA Antigen|
11070076|NCT01412281|EG001|Reported Event|≥18 to ≤60 Years - CSL HA Antigen|
11070077|NCT01412281|EG002|Reported Event|>60 Years - AdImmune HA Antigen|
11070078|NCT01412281|EG003|Reported Event|>60 Years - CSL HA Antigen|
11070079|NCT01412372|BG000|Baseline|Placebo|"This arm will include those who are randomized to the placebo~Placebo: This is an inactive pill"
11070080|NCT01412372|BG001|Baseline|Mesalamine|"This arm is for subjects randomized to the study drug, Mesalamine~Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo"
11070081|NCT01412372|BG002|Baseline|Total|Total of all reporting groups
11070082|NCT01412372|FG000|Participant Flow|Placebo|"This arm will include those who are randomized to the placebo~Placebo: This is an inactive pill"
11070083|NCT01412372|FG001|Participant Flow|Mesalamine|"This arm is for subjects randomized to the study drug, Mesalamine~Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo"
11070084|NCT01412372|OG000|Outcome|Placebo|"This arm will include those who are randomized to the placebo~Placebo: This is an inactive pill"
11070085|NCT01412372|OG001|Outcome|Mesalamine|"This arm is for subjects randomized to the study drug, Mesalamine~Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo"
11070086|NCT01412372|EG000|Reported Event|Placebo|"This arm will include those who are randomized to the placebo~Placebo: This is an inactive pill"
11070087|NCT01412372|EG001|Reported Event|Mesalamine|"This arm is for subjects randomized to the study drug, Mesalamine~Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo"
11070088|NCT01412424|BG000|Baseline|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
11070089|NCT01412424|FG000|Participant Flow|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
11070090|NCT01412424|OG000|Outcome|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
11070091|NCT01412424|OG001|Outcome|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
11070092|NCT01412424|OG002|Outcome|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
11070093|NCT01412424|OG003|Outcome|Octreotide 40, 60, or 80 mg - All Participants|Participants received octreotide 40, 60, or 80 mg orally for up to 13 months.
11070094|NCT01412424|OG000|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
11070095|NCT01412424|EG000|Reported Event|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
11070096|NCT01412424|EG001|Reported Event|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
11070097|NCT01412424|EG002|Reported Event|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
11070098|NCT01412541|BG000|Baseline|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070099|NCT01412541|BG001|Baseline|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070100|NCT01412541|BG002|Baseline|Total|Total of all reporting groups
11070101|NCT01412541|FG000|Participant Flow|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070102|NCT01412541|FG001|Participant Flow|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070103|NCT01412541|OG000|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070104|NCT01412541|OG001|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070105|NCT01412541|OG000|Outcome|Moxy Drug Coated Balloon|"Paclitaxel coated balloon catheter~Moxy Drug Coated Balloon: Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon"
11070106|NCT01412541|OG001|Outcome|Standard Uncoated Angioplasty Balloon|"PTA Catheter~Standard Uncoated Angioplasty Balloon: Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon"
11070107|NCT01412541|OG000|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070108|NCT01412541|EG000|Reported Event|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070109|NCT01412541|EG001|Reported Event|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
11070110|NCT01412554|BG000|Baseline|Longitudinal Insulin Sensitivity|The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
11070111|NCT01412554|FG000|Participant Flow|Longitudinal Insulin Sensitivity|The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
11070112|NCT01412554|OG000|Outcome|Longitudinal Insulin Sensitivity|The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
11070113|NCT01412554|EG000|Reported Event|Longitudinal Insulin Sensitivity|The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
11070114|NCT01412710|BG000|Baseline|4000 IU Group|This group will be given cholecalciferol 4000 IU once daily, orally for 6 months.
11070115|NCT01412710|BG001|Baseline|6000 IU Group|This group will be given cholecalciferol 6000 IU once daily, orally for 6 months.
11070116|NCT01412710|BG002|Baseline|Total|Total of all reporting groups
11070117|NCT01412710|FG000|Participant Flow|4000 IU Group|This group received 4000 IU/day vitamin D3 for 6 months.
11070118|NCT01412710|FG001|Participant Flow|6000 IU Group|This group received 6000 IU/day vitamin D3 for 6 months.
11070119|NCT01412710|OG000|Outcome|4000 IU Group|Vitamin D 4000 IU/day
11070120|NCT01412710|OG001|Outcome|6000 IU Group|Vitamin D 6000 IU/day
11070121|NCT01412710|EG000|Reported Event|4000 IU Vitamin D3/Day|This group will be given cholecalciferol 4000 IU once daily, orally for 6 months.
11070122|NCT01412710|EG001|Reported Event|6000 IU Vitamin D3/Day|This group will be given cholecalciferol 6000 IU once daily, orally for 6 months.
11070123|NCT01412801|BG000|Baseline|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070124|NCT01412801|BG001|Baseline|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070125|NCT01412801|BG002|Baseline|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070126|NCT01412801|BG003|Baseline|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
11070127|NCT01412801|BG004|Baseline|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
11070128|NCT01412801|BG005|Baseline|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
11070129|NCT01412801|BG006|Baseline|Total|Total of all reporting groups
11070130|NCT01412801|FG000|Participant Flow|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070131|NCT01412801|FG001|Participant Flow|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070132|NCT01412801|FG002|Participant Flow|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070133|NCT01412801|FG003|Participant Flow|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
11070134|NCT01412801|FG004|Participant Flow|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
11070135|NCT01412801|FG005|Participant Flow|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
11070136|NCT01412801|OG000|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070137|NCT01412801|OG001|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070138|NCT01412801|OG002|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
11070139|NCT01412801|OG003|Outcome|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
11070140|NCT01412801|OG004|Outcome|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
11070141|NCT01412801|OG005|Outcome|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
11070142|NCT01412801|OG002|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.
11070143|NCT01412801|OG000|Outcome|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
11070144|NCT01412801|OG001|Outcome|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
11070145|NCT01412801|OG002|Outcome|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
11070146|NCT01412801|OG000|Outcome|HIVposCD4LOW|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
11070147|NCT01412801|OG001|Outcome|HIVposCD4HIGH|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
11070148|NCT01412801|OG002|Outcome|HIVneg|"Maternal subjects: HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.~Infants: Infants born to HIV-antibody negative maternal subjects"
11070149|NCT01412801|EG000|Reported Event|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but > 50 cells/μL
11070150|NCT01412801|EG001|Reported Event|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/μL .
11070151|NCT01412801|EG002|Reported Event|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
11070152|NCT01412801|EG003|Reported Event|Total (Infants)|Total number of Infants participated in the study
11070153|NCT01412801|EG004|Reported Event|HIVposCD4LOW_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but > 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
11070154|NCT01412801|EG005|Reported Event|HIVposCD4HIGH_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
11070155|NCT01412801|EG006|Reported Event|HIVneg_Maternal Subjects|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
11070156|NCT01412801|EG007|Reported Event|Total Maternal Subjects|Total number of Maternal subjects participated in the study
11070157|NCT01412866|BG000|Baseline|EDSS With CO Monitor Feedback|Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist
11070158|NCT01412866|BG001|Baseline|EDSS Without CO Monitor Feedback|Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone
11070159|NCT01412866|BG002|Baseline|Total|Total of all reporting groups
11070160|NCT01412866|FG000|Participant Flow|EDSS With CO Monitor Feedback|Electronic decision support system with carbon monoxide (CO) monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist
11070161|NCT01412866|FG001|Participant Flow|EDSS Without CO Monitor Feedback|Electronic decision support system without carbon monoxide (CO) monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone
11070162|NCT01412866|OG000|Outcome|EDSS With CO Monitor Feedback|Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist
11070163|NCT01412866|OG001|Outcome|EDSS Without CO Monitor Feedback|Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone
11070164|NCT01412866|EG000|Reported Event|EDSS With CO Monitor Feedback|Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist
11070165|NCT01412866|EG001|Reported Event|EDSS Without CO Monitor Feedback|Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone
11070166|NCT01412879|BG000|Baseline|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
11070167|NCT01412879|BG001|Baseline|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
11070168|NCT01412879|BG002|Baseline|Total|Total of all reporting groups
11070169|NCT01412879|FG000|Participant Flow|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
11070170|NCT01412879|FG001|Participant Flow|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
11070171|NCT01412879|FG002|Participant Flow|Consolidation Therapy: Stem Cell Transplant|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
11070172|NCT01412879|OG000|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
11070173|NCT01412879|OG001|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
11070174|NCT01412879|OG000|Outcome|R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
11070175|NCT01412879|OG001|Outcome|R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
11070176|NCT01412879|OG002|Outcome|Stem Cell Transplant (Consolidation Therapy)|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
11070177|NCT01412879|EG000|Reported Event|R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
11070178|NCT01412879|EG001|Reported Event|R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
11070179|NCT01412879|EG002|Reported Event|Stem Cell Transplant (Consolidation Therapy)|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
11091780|NCT01536184|EG000|Reported Event|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
11091781|NCT01536184|EG001|Reported Event|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
11091782|NCT01536197|BG000|Baseline|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
11091783|NCT01536197|BG001|Baseline|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
11091784|NCT01536197|BG002|Baseline|Total|Total of all reporting groups
11091785|NCT01536197|FG000|Participant Flow|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
11091786|NCT01536197|FG001|Participant Flow|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
11091787|NCT01536197|OG000|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
11091788|NCT01536197|OG001|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
11091789|NCT01536197|EG000|Reported Event|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
11091790|NCT01536197|EG001|Reported Event|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
11091791|NCT01536262|BG000|Baseline|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11091792|NCT01536262|BG001|Baseline|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11091793|NCT01536262|BG002|Baseline|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11091794|NCT01536262|BG003|Baseline|Total|Total of all reporting groups
11091795|NCT01536262|FG000|Participant Flow|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11226968|NCT02378961|OG002|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
11091796|NCT01536262|FG001|Participant Flow|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11091797|NCT01536262|FG002|Participant Flow|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11091798|NCT01536262|OG000|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11091799|NCT01536262|OG001|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11226969|NCT02378961|OG003|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
11070180|NCT01412918|BG000|Baseline|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
11070181|NCT01412918|BG001|Baseline|No Tinnitus|Individuals without tinnitus.
11070182|NCT01412918|BG002|Baseline|Total|Total of all reporting groups
11070183|NCT01412918|FG000|Participant Flow|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
11070184|NCT01412918|FG001|Participant Flow|No Tinnitus|Individuals without tinnitus.
11070185|NCT01412918|OG000|Outcome|Tinnitus|Tinnitus. genetic sample collection (no intervention)
11070186|NCT01412918|OG000|Outcome|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
11070187|NCT01412918|OG001|Outcome|No Tinnitus|Individuals without tinnitus.
11070188|NCT01412918|EG000|Reported Event|Tinnitus|"Individual with tinnitus. Intervention: inhibitor device demonstration.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
11070189|NCT01412918|EG001|Reported Event|No Tinnitus|Individuals without tinnitus.
11070190|NCT01412944|BG000|Baseline|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
11070191|NCT01412944|BG001|Baseline|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
11070192|NCT01412944|BG002|Baseline|Total|Total of all reporting groups
11070193|NCT01412944|FG000|Participant Flow|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
11070194|NCT01412944|FG001|Participant Flow|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
11070195|NCT01412944|FG002|Participant Flow|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
11070196|NCT01412944|FG003|Participant Flow|AIN457 300 mg - AIN457 300 mg s.c.|
11070197|NCT01412944|FG004|Participant Flow|AIN457 150 mg - AIN457 10 mg/kg I.V.|
11070198|NCT01412944|FG005|Participant Flow|AIN457 300 mg - AIN457 10 mg/kg I.V.|
11070199|NCT01412944|OG000|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
11070200|NCT01412944|OG001|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
11070201|NCT01412944|EG000|Reported Event|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
11070202|NCT01412944|EG001|Reported Event|I.V. Period: AIN457 300 mg - AIN457 300 mg s.c.|
11070203|NCT01412944|EG002|Reported Event|I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
11070204|NCT01412944|EG003|Reported Event|I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
11070205|NCT01412944|EG004|Reported Event|Entire Period: AIN457 150 mg - AIN457 300 mg s.c.|
11070206|NCT01412944|EG005|Reported Event|Entire Period: AIN457 300 mg - AIN457 300 mg s.c.|
11070207|NCT01412944|EG006|Reported Event|Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
11070208|NCT01412944|EG007|Reported Event|Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
11070209|NCT01412944|EG008|Reported Event|Follow up: AIN457 300 mg - AIN457 300 mg s.c.|
11070210|NCT01412944|EG009|Reported Event|Follow-up: AIN457 300 mg - 10 mg/kg i.v.|
11070211|NCT01412944|EG010|Reported Event|Follow-up: AIN457 150 mg - 300 mg s.c.|
11070212|NCT01412944|EG011|Reported Event|Follow-up: AIN457 150 mg - 10 mg/kg i.v.|
11070213|NCT01412957|BG000|Baseline|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
11070214|NCT01412957|BG001|Baseline|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
11070215|NCT01412957|BG002|Baseline|Total|Total of all reporting groups
11070216|NCT01412957|FG000|Participant Flow|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
11070217|NCT01412957|FG001|Participant Flow|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
11070218|NCT01412957|OG000|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
11070219|NCT01412957|OG001|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
11070220|NCT01412957|EG000|Reported Event|Panitumumab Plus BSC|
11070221|NCT01412957|EG001|Reported Event|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
11070222|NCT01412983|BG000|Baseline|Overall Study|All 99 participants in study
11070223|NCT01412983|FG000|Participant Flow|Bausch+Lomb Test Lens Then Ciba Vision Lens|"Bausch+Lomb investigational soft contact lens~Bausch+Lomb Test lens:Ciba Vision Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
11070224|NCT01412983|FG001|Participant Flow|Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision lens:Bausch+Lomb Test Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
11070225|NCT01412983|OG000|Outcome|Bausch+Lomb Test Lens|"Bausch+Lomb investigational soft contact lens~Bausch+Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch+Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
11070226|NCT01412983|OG001|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
11070227|NCT01412983|OG000|Outcome|Bausch + Lomb Test Lens|"Bausch + Lomb investigational soft contact lens~Bausch + Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
11070228|NCT01412983|EG000|Reported Event|Bausch & Lomb Test Lens|"Bausch + Lomb investigational soft contact lens~Bausch & Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
11070229|NCT01412983|EG001|Reported Event|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
11070230|NCT01413087|BG000|Baseline|8 mg BC-819 and Gemcitabine|"gemcitabine dose of 1000mg/m2 + 8 mg of BC-819~Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.~After randomization patients will receive gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819"
11070231|NCT01413087|BG001|Baseline|12 mg BC-819 and Gemcitabine|"gemcitabine dose of 1000mg/m2 + 12 mg of BC-819~Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.~After randomization patients will receive gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819"
11070232|NCT01413087|BG002|Baseline|Total|Total of all reporting groups
11070233|NCT01413087|FG000|Participant Flow|8 mg BC-819 and Gemcitabine|"gemcitabine dose of 1000mg/m2 + 8 mg of BC-819~Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.~After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819"
11070234|NCT01413087|FG001|Participant Flow|12 mg BC-819 and Gemcitabine|"gemcitabine dose of 1000mg/m2 + 12 mg of BC-819~Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.~After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819"
11070235|NCT01413087|OG000|Outcome|8 mg BC-819 and Gemcitabine|"gemcitabine dose of 1000mg/m2 + 8 mg of BC-819~Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.~After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819"
11226970|NCT02378961|EG000|Reported Event|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
10887623|NCT00501852|EG002|Reported Event|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11070236|NCT01413087|OG001|Outcome|12 mg BC-819 and Gemcitabine|"gemcitabine dose of 1000mg/m2 + 12 mg of BC-819~Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.~After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819"
11091800|NCT01536262|OG002|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11091801|NCT01536262|OG002|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11226971|NCT02378961|EG001|Reported Event|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
11226972|NCT02378961|EG002|Reported Event|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
11070237|NCT01413087|EG000|Reported Event|8 mg BC-819 and Gemcitabine|"gemcitabine dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819~Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.~After randomization patients will receive gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819"
11070238|NCT01413087|EG001|Reported Event|12 mg BC-819 and Gemcitabine|"gemcitabine dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819~Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.~After randomization patients will receive gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819"
11070239|NCT01413178|BG000|Baseline|Busulfan + Melphalan|Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant.
11070240|NCT01413178|BG001|Baseline|Melphalan|High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant
11070241|NCT01413178|BG002|Baseline|Total|Total of all reporting groups
11070242|NCT01413178|FG000|Participant Flow|Busulfan + Melphalan|Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant
11070243|NCT01413178|FG001|Participant Flow|Melphalan|High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant
11070244|NCT01413178|OG000|Outcome|Busulfan + Melphalan|Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant
11070245|NCT01413178|OG001|Outcome|Melphalan|High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant
11070246|NCT01413178|EG000|Reported Event|Busulfan + Melphalan|Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant
11070247|NCT01413178|EG001|Reported Event|Melphalan|High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant
11070248|NCT01413191|BG000|Baseline|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
11070249|NCT01413191|FG000|Participant Flow|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
11070250|NCT01413191|OG000|Outcome|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
11070251|NCT01413191|EG000|Reported Event|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
11070252|NCT01413204|BG000|Baseline|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
11070253|NCT01413204|BG001|Baseline|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
11070254|NCT01413204|BG002|Baseline|Placebo|TA-7284 Placebo, once daily for 24 weeks
11070255|NCT01413204|BG003|Baseline|Total|Total of all reporting groups
11070256|NCT01413204|FG000|Participant Flow|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
11070257|NCT01413204|FG001|Participant Flow|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
11070258|NCT01413204|FG002|Participant Flow|Placebo|TA-7284 Placebo, once daily for 24 weeks
11070259|NCT01413204|OG000|Outcome|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
11070260|NCT01413204|OG001|Outcome|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
11070261|NCT01413204|OG002|Outcome|Placebo|TA-7284 Placebo, once daily for 24 weeks
11070262|NCT01413204|EG000|Reported Event|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
11070263|NCT01413204|EG001|Reported Event|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
11070264|NCT01413204|EG002|Reported Event|Placebo|TA-7284 Placebo, once daily for 24 weeks
11070265|NCT01413360|BG000|Baseline|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
11070266|NCT01413360|FG000|Participant Flow|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
11070267|NCT01413360|OG000|Outcome|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
11070268|NCT01413360|EG000|Reported Event|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
11070269|NCT01413503|BG000|Baseline|131I-MIBG|"Patients received 131I-MIBG infused intravenously through a peripheral or central line over 120 minutes.~Of 50 patients enrolled and treated, one patient was lost to follow-up."
11070270|NCT01413503|FG000|Participant Flow|131I-MIBG|Patients received 131I-MIBG 8-12 mCi/kg (maximum 500 mCi ± 10% at investigator's discretion) diluted in 25 ml of normal saline. Patients were infused intravenously through a patient's peripheral or central line over 120 minutes
11070271|NCT01413503|OG000|Outcome|131I-MIBG|Patients received 131I-MIBG infused intravenously through a peripheral or central line over 120 minutes
11070272|NCT01413503|EG000|Reported Event|131I-MIBG|Patients received 131I-MIBG 8-12 mCi/kg (maximum 500 mCi ± 10% at investigator's discretion) diluted in 25 ml of normal saline. Patients were infused intravenously through a patient's peripheral or central line over 120 minutes
11070273|NCT01413516|BG000|Baseline|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study~Placebo: Sugar pill without any active medication"
11070274|NCT01413516|BG001|Baseline|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
11070275|NCT01413516|BG002|Baseline|Total|Total of all reporting groups
11091802|NCT01536262|EG000|Reported Event|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11070276|NCT01413516|FG000|Participant Flow|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo~Placebo: Sugar pill without any active medication"
11070277|NCT01413516|FG001|Participant Flow|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
11070278|NCT01413516|OG000|Outcome|Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study~Placebo: Sugar pill without any active medication"
11070279|NCT01413516|OG001|Outcome|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
11070280|NCT01413516|EG000|Reported Event|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo~Placebo: Sugar pill without any active medication"
11070281|NCT01413516|EG001|Reported Event|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
11070282|NCT01413542|BG000|Baseline|Group 1|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
11070283|NCT01413542|BG001|Baseline|Group 2|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
11070284|NCT01413542|BG002|Baseline|Total|Total of all reporting groups
11070285|NCT01413542|FG000|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibibition)=Group 1|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
11070286|NCT01413542|FG001|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo=Group 1|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
11070287|NCT01413542|FG002|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibition)=Group 2|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
11070288|NCT01413542|FG003|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo = Group 2|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
11070289|NCT01413542|OG000|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
11070290|NCT01413542|OG001|Outcome|Group 2|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
11070291|NCT01413542|OG000|Outcome|Group 1 (Males)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
11070292|NCT01413542|OG001|Outcome|Group 1 (Females)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
11070293|NCT01413542|OG000|Outcome|Group 1|The effect of ACE and/or DPP4 inhibition on change in heart rate in response to substance P (SP) was evaluated.
11070294|NCT01413542|OG000|Outcome|Group 2|The effect of treatment (placebo vs. DPP4 inhibition) on venous GLP-1 levels during intra-arterial GLP-1 infusion.
11070295|NCT01413542|EG000|Reported Event|Group 1 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
11070296|NCT01413542|EG001|Reported Event|Group 1 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
11070297|NCT01413542|EG002|Reported Event|Group 2 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
11070298|NCT01413542|EG003|Reported Event|Group 2 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
11091803|NCT01536262|EG001|Reported Event|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11070299|NCT01413750|BG000|Baseline|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070300|NCT01413750|BG001|Baseline|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070301|NCT01413750|BG002|Baseline|Phase II (Vorinostat)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070302|NCT01413750|BG003|Baseline|Phase II (Placebo)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070303|NCT01413750|BG004|Baseline|Total|Total of all reporting groups
11070304|NCT01413750|FG000|Participant Flow|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070305|NCT01413750|FG001|Participant Flow|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11226973|NCT02378961|EG003|Reported Event|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
11226974|NCT02379052|BG000|Baseline|Placebo|Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
11070306|NCT01413750|FG002|Participant Flow|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070307|NCT01413750|FG003|Participant Flow|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070308|NCT01413750|OG000|Outcome|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070309|NCT01413750|OG001|Outcome|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070310|NCT01413750|OG000|Outcome|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070311|NCT01413750|OG001|Outcome|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070312|NCT01413750|OG000|Outcome|Phase I|All patients enrolled on the Phase I (safety lead-in) portion of the study.
11070313|NCT01413750|EG000|Reported Event|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070314|NCT01413750|EG001|Reported Event|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070315|NCT01413750|EG002|Reported Event|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Voninostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11226975|NCT02379052|BG001|Baseline|Dupilumab 300 mg QW|Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
11226976|NCT02379052|BG002|Baseline|Total|Total of all reporting groups
11226977|NCT02379052|FG000|Participant Flow|Placebo|Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
11070316|NCT01413750|EG003|Reported Event|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11070317|NCT01413958|BG000|Baseline|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
11070318|NCT01413958|BG001|Baseline|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
11070319|NCT01413958|BG002|Baseline|Total|Total of all reporting groups
11070320|NCT01413958|FG000|Participant Flow|Phenylephrine|Phenylephrine hydrochloride, 30 mg extended-release tablets, one tablet every 12 hours for 7 days
11070321|NCT01413958|FG001|Participant Flow|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
11070322|NCT01413958|OG000|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
11070323|NCT01413958|OG001|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
11070324|NCT01413958|OG000|Outcome|Phenylephrine|Phenylephrine hydrochloride 30 mg extended release tablets, one dose every 12 hours for 7 days
11070325|NCT01413958|EG000|Reported Event|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
11070326|NCT01413958|EG001|Reported Event|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
11070327|NCT01414010|BG000|Baseline|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
11070328|NCT01414010|BG001|Baseline|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
11070329|NCT01414010|BG002|Baseline|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
11070330|NCT01414010|BG003|Baseline|Control|Control group, no intervention given.
11070331|NCT01414010|BG004|Baseline|Total|Total of all reporting groups
11070332|NCT01414010|FG000|Participant Flow|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
11070333|NCT01414010|FG001|Participant Flow|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
11070334|NCT01414010|FG002|Participant Flow|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
11070335|NCT01414010|FG003|Participant Flow|Control|Control group, no intervention given.
11070336|NCT01414010|OG000|Outcome|Amoxicillin - Before Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
11070337|NCT01414010|OG001|Outcome|Amoxicillin - During Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
11070338|NCT01414010|OG002|Outcome|Amoxicillin - After Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
11070339|NCT01414010|OG003|Outcome|Control|Control group - no intervention given.
11070340|NCT01414010|OG004|Outcome|Trametes Versicolor Extract - Before Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
11070341|NCT01414010|OG005|Outcome|Trametes Versicolor Extract - During Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
11070342|NCT01414010|OG006|Outcome|Trametes Versicolor Extract - After Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
11070343|NCT01414010|OG007|Outcome|Saccharomyces Boulardii - Before Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
11070344|NCT01414010|OG008|Outcome|Saccharomyces Boulardii - During Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
11070345|NCT01414010|OG009|Outcome|Saccharomyces Boulardii - After Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
11070346|NCT01414010|EG000|Reported Event|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
11070347|NCT01414010|EG001|Reported Event|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
11070348|NCT01414010|EG002|Reported Event|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
11070349|NCT01414010|EG003|Reported Event|Control|Control group, no intervention given.
11070350|NCT01414036|BG000|Baseline|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
11070351|NCT01414036|BG001|Baseline|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
11070352|NCT01414036|BG002|Baseline|Total|Total of all reporting groups
11070353|NCT01414036|FG000|Participant Flow|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
11070354|NCT01414036|FG001|Participant Flow|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
11070355|NCT01414036|OG000|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
11070356|NCT01414036|OG001|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
11070357|NCT01414036|EG000|Reported Event|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
11070358|NCT01414036|EG001|Reported Event|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
11070359|NCT01414075|BG000|Baseline|Arm A + E (Participants on HD): Roxadustat Only, No Iron|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.
11070360|NCT01414075|BG001|Baseline|Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
11070361|NCT01414075|BG002|Baseline|Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks.
11226978|NCT02379052|FG001|Participant Flow|Dupilumab 300 mg QW|Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
11226979|NCT02379052|OG000|Outcome|Placebo|Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
11226980|NCT02379052|OG001|Outcome|Dupilumab 300 mg QW|Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
11226981|NCT02379052|EG000|Reported Event|Placebo|Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
10887624|NCT00501852|EG003|Reported Event|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11349057|NCT04126343|BG001|Baseline|Treatment Sequence: ACB|Participants received PSL, MXF, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11070362|NCT01414075|BG003|Baseline|Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg|Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
11070363|NCT01414075|BG004|Baseline|Total|Total of all reporting groups
11226982|NCT02379052|EG001|Reported Event|Dupilumab 300 mg QW|Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
11226983|NCT02379078|BG000|Baseline|Shared Decision-making Aid|"At study start (step 1: provider-directed intervention phase): Online shared decision-making aid, 1-page provider enabler, provider training video made available to health care providers~At 6 months (step 2: provider- and patient-directed phase): Online shared decision-making aid, 1-page patient enabler, patient training video also made available to patients (in addition to health care providers)~Shared decision-making aid: The IP-SDM toolkit consists of an online shared decision-making aid, 1-page provider enabler, a provider training video,1-page patient enabler, and a patient training video.~Generic online diabetes resources: Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website"
11070364|NCT01414075|FG000|Participant Flow|Arm A + E (Participants on HD): Roxadustat Only, No Iron|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 milligrams [mg]) based on weight and hemoglobin (Hb) level, administered orally 3 times weekly (TIW) for 12 weeks.
11070365|NCT01414075|FG001|Participant Flow|Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
11091804|NCT01536262|EG002|Reported Event|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
11349058|NCT04126343|BG002|Baseline|Treatment Sequence: BAC|Participants received Placebo, PSL, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11070366|NCT01414075|FG002|Participant Flow|Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks.
11070367|NCT01414075|FG003|Participant Flow|Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg|Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
11070368|NCT01414075|OG000|Outcome|Arm A + E (Participants on HD): Roxadustat Only, No Iron|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.
11070369|NCT01414075|OG001|Outcome|Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
11070370|NCT01414075|OG002|Outcome|Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks.
11070371|NCT01414075|OG003|Outcome|Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg|Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
11070372|NCT01414075|EG000|Reported Event|Arm A + E (Participants on HD): Roxadustat Only, No Iron|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.
11070373|NCT01414075|EG001|Reported Event|Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
11070374|NCT01414075|EG002|Reported Event|Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg|Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks.
11070375|NCT01414075|EG003|Reported Event|Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg|Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
11070376|NCT01414114|BG000|Baseline|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
11070377|NCT01414114|FG000|Participant Flow|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
11070378|NCT01414114|OG000|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
11070379|NCT01414114|OG001|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
10887625|NCT00501852|EG004|Reported Event|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
11070380|NCT01414114|OG002|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
11070381|NCT01414114|EG000|Reported Event|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
11070382|NCT01414153|BG000|Baseline|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
11070383|NCT01414153|BG001|Baseline|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
11070384|NCT01414153|BG002|Baseline|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
11070385|NCT01414153|BG003|Baseline|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
11070386|NCT01414153|BG004|Baseline|Total|Total of all reporting groups
11070387|NCT01414153|FG000|Participant Flow|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
11226984|NCT02379078|BG001|Baseline|Generic Hard-copy Diabetes Resources|"At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the CDA CPG and postcard outlining online resources made available to health care providers~At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients~In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website.~Generic hard copy diabetes resources: A hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet~Generic online diabetes resources: Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website"
11226985|NCT02379078|BG002|Baseline|Total|Total of all reporting groups
11226986|NCT02379078|FG000|Participant Flow|Shared Decision-making Aid|"At study start (step 1: provider-directed intervention phase): Online shared decision-making aid, 1-page provider enabler, provider training video made available to health care providers~At 6 months (step 2: provider- and patient-directed phase): Online shared decision-making aid, 1-page patient enabler, patient training video also made available to patients (in addition to health care providers)~Shared decision-making aid: The interprofessional (IP)-SDM toolkit consists of an online shared decision-making aid, 1-page provider enabler, a provider training video,1-page patient enabler, and a patient training video.~Generic online diabetes resources: Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the Canadian Diabetes Association website"
11233688|NCT02430389|EG000|Reported Event|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
11233689|NCT02430389|EG001|Reported Event|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
10887626|NCT00501852|EG005|Reported Event|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
10887627|NCT00501891|BG000|Baseline|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
10887628|NCT00501891|FG000|Participant Flow|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
11070388|NCT01414153|FG001|Participant Flow|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
11070389|NCT01414153|FG002|Participant Flow|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
11070390|NCT01414153|FG003|Participant Flow|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
11070391|NCT01414153|OG000|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
11070392|NCT01414153|OG001|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
11070393|NCT01414153|OG002|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
11070394|NCT01414153|OG003|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
11070395|NCT01414153|EG000|Reported Event|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
11070396|NCT01414153|EG001|Reported Event|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
11070397|NCT01414153|EG002|Reported Event|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
11070398|NCT01414153|EG003|Reported Event|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
11070399|NCT01414205|BG000|Baseline|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
11070400|NCT01414205|BG001|Baseline|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
11070401|NCT01414205|BG002|Baseline|Total|Total of all reporting groups
11070402|NCT01414205|FG000|Participant Flow|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
11070403|NCT01414205|FG001|Participant Flow|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
11070404|NCT01414205|OG000|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
11070405|NCT01414205|OG001|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
11070406|NCT01414205|EG000|Reported Event|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
11070407|NCT01414205|EG001|Reported Event|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
11070408|NCT01414244|BG000|Baseline|Glutamine|Oral Glutamine Powder
11070409|NCT01414244|BG001|Baseline|Placebo|Oral Whey Protein Powder
11070410|NCT01414244|BG002|Baseline|Total|Total of all reporting groups
11070411|NCT01414244|FG000|Participant Flow|Glutamine|Oral Glutamine Powder
10887629|NCT00501891|OG000|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
11070412|NCT01414244|FG001|Participant Flow|Placebo|Oral Whey Protein Powder
11070413|NCT01414244|OG000|Outcome|Glutamine|Oral Glutamine Powder
11070414|NCT01414244|OG001|Outcome|Placebo|Oral Whey Protein Powder
11070415|NCT01414244|EG000|Reported Event|Glutamine|Oral Glutamine Powder
11070416|NCT01414244|EG001|Reported Event|Placebo|Oral Whey Protein Powder
11070417|NCT01414257|BG000|Baseline|Methotrexate|
11070418|NCT01414257|FG000|Participant Flow|Methotrexate|
11070419|NCT01414257|OG000|Outcome|Methotrexate|
11070420|NCT01414257|EG000|Reported Event|Methotrexate|
11070421|NCT01414413|BG000|Baseline|Home Assessment and Initiation of ART|8194 adults resident in 3213 households
11070422|NCT01414413|BG001|Baseline|Clinic-based ART Assessment and Initiation|8466 adults resident in 3397 households
11070423|NCT01414413|BG002|Baseline|Total|Total of all reporting groups
11070424|NCT01414413|FG000|Participant Flow|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
11070425|NCT01414413|FG001|Participant Flow|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
11070426|NCT01414413|OG000|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
11070427|NCT01414413|OG001|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
11070428|NCT01414413|EG000|Reported Event|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
11070429|NCT01414413|EG001|Reported Event|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
11070430|NCT01414426|BG000|Baseline|Arm I (Chemoprevention)|"Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~vandetanib: Given PO~immunohistochemistry staining method: Correlative studies~laboratory biomarker analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies"
11070431|NCT01414426|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~immunohistochemistry staining method: Correlative studies~laboratory biomarker analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies"
11070432|NCT01414426|BG002|Baseline|Total|Total of all reporting groups
11070433|NCT01414426|FG000|Participant Flow|Arm I (Chemoprevention)|"Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~vandetanib: Given PO~immunohistochemistry staining method: Correlative studies~laboratory biomarker analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies"
11070434|NCT01414426|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~immunohistochemistry staining method: Correlative studies~laboratory biomarker analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies"
11070435|NCT01414426|OG000|Outcome|Arm I (Chemoprevention)|"Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~vandetanib: Given PO~immunohistochemistry staining method: Correlative studies~laboratory biomarker analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies"
11070436|NCT01414426|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~immunohistochemistry staining method: Correlative studies~laboratory biomarker analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies"
11070437|NCT01414426|EG000|Reported Event|Arm I (Chemoprevention)|"Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~vandetanib: Given PO~immunohistochemistry staining method: Correlative studies~laboratory biomarker analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies"
11091805|NCT01536366|BG000|Baseline|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
11070438|NCT01414426|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~immunohistochemistry staining method: Correlative studies~laboratory biomarker analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies"
11070439|NCT01414634|BG000|Baseline|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070440|NCT01414634|FG000|Participant Flow|ETIMS 1x10^3|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
11070441|NCT01414634|FG001|Participant Flow|ETIMS 1x10^5|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
11070442|NCT01414634|FG002|Participant Flow|ETIMS 1x10^7|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
11070443|NCT01414634|FG003|Participant Flow|ETIMS 1x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
11070444|NCT01414634|FG004|Participant Flow|ETIMS 5x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
11070445|NCT01414634|FG005|Participant Flow|ETIMS 1x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
11070446|NCT01414634|FG006|Participant Flow|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
11070447|NCT01414634|FG007|Participant Flow|ETIMS 3x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
11233690|NCT02430480|BG000|Baseline|1/Arm 1- Enzalutamide and Goserelin|"Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.~Goserelin: 10.8mg administered subcutaneously every 12 weeks (2 doses)~Enzalutamide: 160mg orally, daily for 24 weeks~mpMRI: Multiparametric MRI - One at baseline and after 6 months of treatment"
11070448|NCT01414634|OG000|Outcome|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070449|NCT01414634|EG000|Reported Event|ETIMS 1x10^3|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070450|NCT01414634|EG001|Reported Event|ETIMS 1x10^5|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070451|NCT01414634|EG002|Reported Event|ETIMS 1x10^7|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070452|NCT01414634|EG003|Reported Event|ETIMS 1x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070453|NCT01414634|EG004|Reported Event|ETIMS 5x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11335668|NCT03554629|OG005|Outcome|30 Second LOW RR 6 With Actual Respiration Rate of 24|False Low RR for 15 - 29 seconds with patient interface gas sample for capnography derived respiration measurement under condition of subject respiration rate of 24 with supplemental O2 at 5lpm.
11070454|NCT01414634|EG005|Reported Event|ETIMS 1x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070455|NCT01414634|EG006|Reported Event|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070456|NCT01414634|EG007|Reported Event|ETIMS 3x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
11070457|NCT01414738|BG000|Baseline|Radiation|"Whole-Brain Radiotherapy~Radiotherapy: Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost"
11070458|NCT01414738|FG000|Participant Flow|Radiation|"Whole-Brain Radiotherapy~Radiotherapy: Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost"
11070459|NCT01414738|OG000|Outcome|Radiation|"Whole-Brain Radiotherapy~Radiotherapy: Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost"
11070460|NCT01414738|EG000|Reported Event|Radiation|"Whole-Brain Radiotherapy~Radiotherapy: Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost"
11070461|NCT01414855|BG000|Baseline|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
11070462|NCT01414855|FG000|Participant Flow|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
11070463|NCT01414855|OG000|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
11070464|NCT01414855|EG000|Reported Event|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
11070465|NCT01415232|BG000|Baseline|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
11070466|NCT01415232|FG000|Participant Flow|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
11070467|NCT01415232|OG000|Outcome|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth from the skin to the epidural space in morbidly obese parturients
11070468|NCT01415232|EG000|Reported Event|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
11070469|NCT01415349|BG000|Baseline|Safety Analysis Set|Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
11070470|NCT01415349|FG000|Participant Flow|SSP-002358 First|A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2
11070471|NCT01415349|FG001|Participant Flow|SSP-002358 + Omeprazole First|A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2
11070472|NCT01415349|OG000|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
11070473|NCT01415349|OG001|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
11070474|NCT01415349|EG000|Reported Event|SSP-002358 Alone|All subjects that received only SSP-002358
11070475|NCT01415349|EG001|Reported Event|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
11070476|NCT01415401|BG000|Baseline|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
11070477|NCT01415401|FG000|Participant Flow|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
11070478|NCT01415401|OG000|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
11070479|NCT01415401|EG000|Reported Event|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
11226987|NCT02379078|FG001|Participant Flow|Generic Hard-copy Diabetes Resources|"At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the Canadian Diabetes Association (CDA) Clinical Practice Guidelines (CPG) and postcard outlining online resources made available to health care providers~At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients~In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website.~Generic hard copy diabetes resources: A hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet~Generic online diabetes resources: Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website"
11070480|NCT01415427|BG000|Baseline|PBO-QOW|Placebo in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
11070481|NCT01415427|BG001|Baseline|PBO-QW|Placebo in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
11070482|NCT01415427|BG002|Baseline|QOW-QOW|BMN110 2.0 mg/kg/qow in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
11070483|NCT01415427|BG003|Baseline|QW-QW|BMN110 2.0 mg/kg/qw in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
11070484|NCT01415427|BG004|Baseline|Total|Total of all reporting groups
11070485|NCT01415427|FG000|Participant Flow|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
11070486|NCT01415427|FG001|Participant Flow|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
11070487|NCT01415427|FG002|Participant Flow|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
11070488|NCT01415427|FG003|Participant Flow|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
11070489|NCT01415427|OG000|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
11070490|NCT01415427|OG001|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
11070491|NCT01415427|OG002|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
11070492|NCT01415427|OG003|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
11070493|NCT01415427|OG004|Outcome|Total|All treatment groups
11070494|NCT01415427|EG000|Reported Event|PBO-QOW|PBO-QOW
11070495|NCT01415427|EG001|Reported Event|PBO-QW|PBO-QW
11070496|NCT01415427|EG002|Reported Event|QOW-QOW|QOW-QOW
11070497|NCT01415427|EG003|Reported Event|QW-QW|QW-QW
11070498|NCT01415427|EG004|Reported Event|Total|Total
11070499|NCT01415440|BG000|Baseline|Healthy Control|Baseline evaluation only
11070500|NCT01415440|BG001|Baseline|ADHD - Placebo|ADHD participants randomized to receive placebo for 12 weeks of treatment
11070501|NCT01415440|BG002|Baseline|ADHD - Vyvanse|ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
11070502|NCT01415440|BG003|Baseline|Total|Total of all reporting groups
11070503|NCT01415440|FG000|Participant Flow|Healthy Control|Baseline evaluation only
11070504|NCT01415440|FG001|Participant Flow|ADHD - Placebo|ADHD participants randomized to receive placebo for 12 weeks of treatment
11070505|NCT01415440|FG002|Participant Flow|ADHD - Vyvanse|ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
11070506|NCT01415440|OG000|Outcome|ADHD - Placebo|ADHD participants randomized to receive placebo for 12 weeks of treatment
11070507|NCT01415440|OG001|Outcome|ADHD - Vyvanse|ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
11070508|NCT01415440|EG000|Reported Event|Healthy Control|Baseline evaluation only
11070509|NCT01415440|EG001|Reported Event|ADHD - Placebo|ADHD participants randomized to receive placebo for 12 weeks of treatment
11070510|NCT01415440|EG002|Reported Event|ADHD - Vyvanse|ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
11070511|NCT01415453|BG000|Baseline|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
11070512|NCT01415453|FG000|Participant Flow|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
11070513|NCT01415453|OG000|Outcome|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
11070514|NCT01415453|EG000|Reported Event|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
11091806|NCT01536366|BG001|Baseline|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
11226988|NCT02379078|OG000|Outcome|Shared Decision-making Aid|"At study start (step 1: provider-directed intervention phase): Online shared decision-making aid, 1-page provider enabler, provider training video made available to health care providers~At 6 months (step 2: provider- and patient-directed phase): Online shared decision-making aid, 1-page patient enabler, patient training video also made available to patients (in addition to health care providers)~Shared decision-making aid: The IP-SDM toolkit consists of an online shared decision-making aid, 1-page provider enabler, a provider training video,1-page patient enabler, and a patient training video.~Generic online diabetes resources: Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website"
11226989|NCT02379078|OG001|Outcome|Generic Hard-copy Diabetes Resources|"At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the CDA CPG and postcard outlining online resources made available to health care providers~At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients~In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website.~Generic hard copy diabetes resources: A hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet~Generic online diabetes resources: Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website"
11226990|NCT02379078|EG000|Reported Event|Shared Decision-making Aid|"At study start (step 1: provider-directed intervention phase): Online shared decision-making aid, 1-page provider enabler, provider training video made available to health care providers~At 6 months (step 2: provider- and patient-directed phase): Online shared decision-making aid, 1-page patient enabler, patient training video also made available to patients (in addition to health care providers)~Shared decision-making aid: The IP-SDM toolkit consists of an online shared decision-making aid, 1-page provider enabler, a provider training video,1-page patient enabler, and a patient training video.~Generic online diabetes resources: Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website"
11335669|NCT03554629|OG000|Outcome|20 Second No Breath Alarm With Actual Respiration Rate of 6|"When actual respiration rate was 6 breaths per minute~CO2 derived RR from the gas sample provide by the CO2 Cannula Sampling Filterline (CCSF)"
11070515|NCT01415518|BG000|Baseline|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
11070516|NCT01415518|BG001|Baseline|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
11070517|NCT01415518|BG002|Baseline|Total|Total of all reporting groups
11070518|NCT01415518|FG000|Participant Flow|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
11070519|NCT01415518|FG001|Participant Flow|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
11070520|NCT01415518|OG000|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
11070521|NCT01415518|OG001|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
11070522|NCT01415518|EG000|Reported Event|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
11070523|NCT01415518|EG001|Reported Event|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
11070524|NCT01415531|BG000|Baseline|Placebo|Dose-matched placebo
11070525|NCT01415531|BG001|Baseline|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
11070526|NCT01415531|BG002|Baseline|Total|Total of all reporting groups
11070527|NCT01415531|FG000|Participant Flow|Placebo|Dose-matched placebo
11070528|NCT01415531|FG001|Participant Flow|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
11070529|NCT01415531|OG000|Outcome|Placebo|Dose-matched placebo
11070530|NCT01415531|OG001|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
11070531|NCT01415531|EG000|Reported Event|Placebo|Dose-matched placebo
11070532|NCT01415531|EG001|Reported Event|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
11070533|NCT01415583|BG000|Baseline|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
11070534|NCT01415583|BG001|Baseline|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
11070535|NCT01415583|BG002|Baseline|Total|Total of all reporting groups
11070536|NCT01415583|FG000|Participant Flow|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
11070537|NCT01415583|FG001|Participant Flow|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
11070538|NCT01415583|OG000|Outcome|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
11070539|NCT01415583|OG001|Outcome|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
11070540|NCT01415583|EG000|Reported Event|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
11070541|NCT01415583|EG001|Reported Event|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
11070542|NCT01415908|BG000|Baseline|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
11070543|NCT01415908|BG001|Baseline|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
11070544|NCT01415908|BG002|Baseline|Total|Total of all reporting groups
11070545|NCT01415908|FG000|Participant Flow|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
11070546|NCT01415908|FG001|Participant Flow|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
11070547|NCT01415908|OG000|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
11070548|NCT01415908|OG001|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
11070549|NCT01415908|EG000|Reported Event|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
11070550|NCT01415908|EG001|Reported Event|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
11070551|NCT01415921|BG000|Baseline|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
11070552|NCT01415921|BG001|Baseline|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
11070553|NCT01415921|BG002|Baseline|Total|Total of all reporting groups
11070554|NCT01415921|FG000|Participant Flow|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
11070555|NCT01415921|FG001|Participant Flow|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
11070556|NCT01415921|OG000|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
11070557|NCT01415921|OG001|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
11070558|NCT01415921|EG000|Reported Event|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
11070559|NCT01415921|EG001|Reported Event|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
11070560|NCT01415934|BG000|Baseline|Continue Statins|Patients in the continuation group continued to receive statins.
11070561|NCT01415934|BG001|Baseline|Discontinue Statins|Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.
11070562|NCT01415934|BG002|Baseline|Total|Total of all reporting groups
11070563|NCT01415934|FG000|Participant Flow|Continue Statins|Participant will continue on statins as per usual
11070564|NCT01415934|FG001|Participant Flow|Discontinue Statins|"Participant will stop taking their statin drugs~discontinue statins: patients will be randomized to either continue taking statins or discontinue."
11070565|NCT01415934|OG000|Outcome|Continue Statins|Patients in the continuation group continued to receive statins.
11070566|NCT01415934|OG001|Outcome|Discontinue Statins|Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.
11070567|NCT01415934|EG000|Reported Event|Continue Statins|Participant will continue on statins as per usual
11070568|NCT01415934|EG001|Reported Event|Discontinue Statins|"Participant will stop taking their statin drugs~discontinue statins: patients will be randomized to either continue taking statins or discontinue."
11070569|NCT01415960|BG000|Baseline|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
11070570|NCT01415960|FG000|Participant Flow|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
11070571|NCT01415960|OG000|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
11091807|NCT01536366|BG002|Baseline|Total|Total of all reporting groups
11070572|NCT01415960|EG000|Reported Event|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
11070573|NCT01416025|BG000|Baseline|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
11070574|NCT01416025|BG001|Baseline|Standard Dosing|Standard doses of voriconazole will be used
11070575|NCT01416025|BG002|Baseline|Total|Total of all reporting groups
11070576|NCT01416025|FG000|Participant Flow|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
11070577|NCT01416025|FG001|Participant Flow|Standard Dosing|Standard doses of voriconazole will be used
11070578|NCT01416025|OG000|Outcome|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
11070579|NCT01416025|OG001|Outcome|Standard Dosing|Standard doses of voriconazole will be used
11070580|NCT01416025|EG000|Reported Event|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
11070581|NCT01416025|EG001|Reported Event|Standard Dosing|Standard doses of voriconazole will be used
11070582|NCT01416129|BG000|Baseline|Active Comparator: Prosthetic Socket Standard of Care|This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity.
11070583|NCT01416129|BG001|Baseline|Active Comparator: Prosthetic Brimless Socket|This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity.
11233691|NCT02430480|FG000|Participant Flow|1/Arm 1- Enzalutamide and Goserelin|"Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.~Goserelin: 10.8mg administered subcutaneously every 12 weeks (2 doses)~Enzalutamide: 160mg orally, daily for 24 weeks~mpMRI: Multiparametric MRI - One at baseline and after 6 months of treatment"
11070584|NCT01416129|BG002|Baseline|Total|Total of all reporting groups
11070585|NCT01416129|FG000|Participant Flow|Standard of Care Prosthetic Socket (Ischial Containment)|In this crossover study, 5 subjects were randomized to continue using their ischial containment socket socket first. After assessment, subjects crossed over into the other condition.
11070586|NCT01416129|FG001|Participant Flow|Prosthetic Socket (Experimental): Brimless Socket|5 subjects randomized to the experimental condition then, following assessment, crossed over to accommodate and re-test with the standard of care (ischial containment socket).
11070587|NCT01416129|OG000|Outcome|Control Condition: Prosthetic Socket Standard of Care|
11335670|NCT03554629|OG001|Outcome|30 Second No Breath Alarm With Actual Respiration Rate of 6|"When actual respiration rate was 6 .~CO2 derived RR from the gas sample provide by the CO2 Cannula Sampling Filterline (CCSF)"
11070588|NCT01416129|OG001|Outcome|Active Comparator/Experimental: Prosthetic Brimless Socket|
11070589|NCT01416129|EG000|Reported Event|Vacuum Assisted Socket|
11070590|NCT01416129|EG001|Reported Event|Standard of Care Socket|
11070591|NCT01416142|BG000|Baseline|All Eligible Baseline Participants|Participants crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
11070592|NCT01416142|FG000|Participant Flow|PureVision2 HD:Spectacles|Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission.
11070593|NCT01416142|FG001|Participant Flow|Spectacles:PureVision2 HD|Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission.
11070594|NCT01416142|FG002|Participant Flow|PureVision2 HD|Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week.
11070595|NCT01416142|OG000|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. The lower the mean logMAR the better the VA.
11070596|NCT01416142|OG001|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
11070597|NCT01416142|OG000|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
11070598|NCT01416142|OG002|Outcome|No Difference|Participants reporting no difference between the PureVision2 HD lens and spectacles
11070599|NCT01416142|EG000|Reported Event|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
11070600|NCT01416142|EG001|Reported Event|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
11070601|NCT01416155|BG000|Baseline|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
11070602|NCT01416155|FG000|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions of natalizumab open label every 4 weeks
11070603|NCT01416155|OG000|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
11070604|NCT01416155|EG000|Reported Event|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
11070605|NCT01416181|BG000|Baseline|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
11070606|NCT01416181|BG001|Baseline|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
11070607|NCT01416181|BG002|Baseline|Total|Total of all reporting groups
11070608|NCT01416181|FG000|Participant Flow|Placebo|Part 1: participants were randomized to receive placebo intravenously (IV) every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
11070609|NCT01416181|FG001|Participant Flow|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
11070610|NCT01416181|OG000|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
11070611|NCT01416181|OG001|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
11070612|NCT01416181|EG000|Reported Event|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
11070613|NCT01416181|EG001|Reported Event|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
11070614|NCT01416194|BG000|Baseline|Bazedoxifene|Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070615|NCT01416194|BG001|Baseline|Raloxifene|Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070616|NCT01416194|BG002|Baseline|Bisphosphonate|Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070617|NCT01416194|BG003|Baseline|Total|Total of all reporting groups
11070618|NCT01416194|FG000|Participant Flow|Bazedoxifene|Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per summary of product characteristics (SmPC) and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070619|NCT01416194|FG001|Participant Flow|Raloxifene|Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070620|NCT01416194|FG002|Participant Flow|Bisphosphonate|Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070621|NCT01416194|OG000|Outcome|Bazedoxifene|Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070622|NCT01416194|OG001|Outcome|Raloxifene|Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070623|NCT01416194|OG002|Outcome|Bisphosphonate|Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070624|NCT01416194|OG001|Outcome|Bisphosphonate|Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070625|NCT01416194|OG002|Outcome|Raloxifene|Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070626|NCT01416194|EG000|Reported Event|Bazedoxifene|Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070627|NCT01416194|EG001|Reported Event|Raloxifene|Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070628|NCT01416194|EG002|Reported Event|Bisphosphonate|Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
11070629|NCT01416389|BG000|Baseline|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
11070630|NCT01416389|BG001|Baseline|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
11070631|NCT01416389|BG002|Baseline|Total|Total of all reporting groups
11070632|NCT01416389|FG000|Participant Flow|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
11091808|NCT01536366|FG000|Participant Flow|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
11070633|NCT01416389|FG001|Participant Flow|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
11070634|NCT01416389|OG000|Outcome|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
11070635|NCT01416389|OG001|Outcome|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
11070636|NCT01416389|OG000|Outcome|LY2523355|LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).
11070637|NCT01416389|OG000|Outcome|LSN2546307|LSN2546307 is the metabolite of LY2523355. LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).
11070638|NCT01416389|EG000|Reported Event|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
11226991|NCT02379078|EG001|Reported Event|Generic Hard-copy Diabetes Resources|"At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the CDA CPG and postcard outlining online resources made available to health care providers~At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients~In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website.~Generic hard copy diabetes resources: A hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet~Generic online diabetes resources: Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website"
11226992|NCT02379091|BG000|Baseline|Placebo|Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11070639|NCT01416389|EG001|Reported Event|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
11070640|NCT01416441|BG000|Baseline|Aripiprazole (Once Weekly)|Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability.
11070641|NCT01416441|FG000|Participant Flow|Aripiprazole (Once Weekly)|Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability.
11070642|NCT01416441|OG000|Outcome|Aripiprazole (Once Weekly)|Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability.
11070643|NCT01416441|EG000|Reported Event|Aripiprazole (Once Weekly)|Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability.
11070644|NCT01416571|BG000|Baseline|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
11070645|NCT01416571|FG000|Participant Flow|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
11070646|NCT01416571|OG000|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
11070647|NCT01416571|EG000|Reported Event|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
11070648|NCT01416584|BG000|Baseline|Usual Care Control|Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.
11070649|NCT01416584|BG001|Baseline|Methadone Contingency Group|Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.
11070650|NCT01416584|BG002|Baseline|Methadone & Abstinence Contingency|Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
11226993|NCT02379091|BG001|Baseline|Namilumab 20 mg/mL|Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11226994|NCT02379091|BG002|Baseline|Namilumab 80 mg/mL|Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11226995|NCT02379091|BG003|Baseline|Namilumab 150 mg/mL|Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11226996|NCT02379091|BG004|Baseline|Total|Total of all reporting groups
11226997|NCT02379091|FG000|Participant Flow|Placebo|Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11070651|NCT01416584|BG003|Baseline|Total|Total of all reporting groups
11070652|NCT01416584|FG000|Participant Flow|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but are not required to join in order to gain access to the workplace.
11070653|NCT01416584|FG001|Participant Flow|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
11226998|NCT02379091|FG001|Participant Flow|Namilumab 20 mg/mL|Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11226999|NCT02379091|FG002|Participant Flow|Namilumab 80 mg/mL|Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11070654|NCT01416584|FG002|Participant Flow|Methadone & Abstinence Contingency|Participants were be able to access work if they enroll in the methadone treatment and consistently take their medication, but also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
11070655|NCT01416584|OG000|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
11070656|NCT01416584|OG001|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
11070657|NCT01416584|OG002|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
11070658|NCT01416584|OG000|Outcome|Usual Care Control|Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.
11070659|NCT01416584|OG001|Outcome|Methadone Contingency Group|Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.
11070660|NCT01416584|OG002|Outcome|Methadone & Abstinence Contingency|Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
11070661|NCT01416584|OG000|Outcome|Usual Care Control|Participants could work and earn stipends, but did not have to enter methadone treatment or provide drug-free urine samples to work or earn money.
11070662|NCT01416584|OG001|Outcome|Methadone Contingency Group|Participants were required to stay enrolled in methadone treatment to work and earn wages.
11070663|NCT01416584|OG002|Outcome|Methadone & Abstinence Contingency|Participants were required to stay enrolled in methadone treatment to work and earn wages and provide urine samples negative for opiates and cocaine to maintain maximum pay.
11070664|NCT01416584|EG000|Reported Event|Usual Care Control|Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.
11070665|NCT01416584|EG001|Reported Event|Methadone Contingency Group|Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.
11070666|NCT01416584|EG002|Reported Event|Methadone & Abstinence Contingency|Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
11070667|NCT01416610|BG000|Baseline|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
11070668|NCT01416610|FG000|Participant Flow|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
11070669|NCT01416610|OG000|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
11070670|NCT01416610|OG000|Outcome|Baseline|Baseline Visit
11070671|NCT01416610|OG001|Outcome|Week 12|Week 12 Visit
11070672|NCT01416610|OG002|Outcome|End of Treatment|End of Treatment Visit
11070673|NCT01416610|OG003|Outcome|End of Follow-up|End of Follow-up Visit
11070674|NCT01416610|EG000|Reported Event|Safety Population|Participants who started treatment
11070675|NCT01416805|BG000|Baseline|Computerized Cognitive Behavioral Therapy|Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
11070676|NCT01416805|BG001|Baseline|Treatment as Usual|Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
11070677|NCT01416805|BG002|Baseline|Total|Total of all reporting groups
11070678|NCT01416805|FG000|Participant Flow|Computerized Cognitive Behavioral Therapy|Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
11070679|NCT01416805|FG001|Participant Flow|Treatment as Usual|Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
11070680|NCT01416805|OG000|Outcome|Computerized Cognitive Behavioral Therapy|Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
11070681|NCT01416805|OG001|Outcome|Treatment as Usual|Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
11091809|NCT01536366|FG001|Participant Flow|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
11091810|NCT01536366|OG000|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
11070682|NCT01416805|EG000|Reported Event|Computerized Cognitive Behavioral Therapy|Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
11070683|NCT01416805|EG001|Reported Event|Treatment as Usual|Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
11070684|NCT01416987|BG000|Baseline|Pergoveris®|Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
11070685|NCT01416987|FG000|Participant Flow|Pergoveris®|Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
11070686|NCT01416987|OG000|Outcome|Pergoveris®|Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
11070687|NCT01416987|EG000|Reported Event|Pergoveris®|Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
11227000|NCT02379091|FG003|Participant Flow|Namilumab 150 mg/mL|Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227001|NCT02379091|OG000|Outcome|Placebo|Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227002|NCT02379091|OG001|Outcome|Namilumab 20 mg/mL|Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227003|NCT02379091|OG002|Outcome|Namilumab 80 mg/mL|Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11070688|NCT01417000|BG000|Baseline|Cy/GVAX + CRS-207|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
11070689|NCT01417000|BG001|Baseline|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
11070690|NCT01417000|BG002|Baseline|Total|Total of all reporting groups
11070691|NCT01417000|FG000|Participant Flow|Cy/GVAX + CRS-207|200 mg per square meter (mg/m^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units [CFU]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
11070692|NCT01417000|FG001|Participant Flow|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
11335671|NCT03554629|OG002|Outcome|15 Second LOW RR 4 Alarm With Actual Respiration Rate of 6|False Low RR for 15 - 29 seconds with patient interface gas sample for capnography derived respiration measurement under condition of subject respiration rate of 24 with supplemental O2 at 5lpm.
11070693|NCT01417000|OG000|Outcome|Cy/GVAX + CRS-207|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
11070694|NCT01417000|OG001|Outcome|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
11091811|NCT01536366|OG001|Outcome|Repaglinide|Repaglinide 0.5 mg
11091812|NCT01536366|EG000|Reported Event|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
11070695|NCT01417000|EG000|Reported Event|Cy/GVAX + CRS-207|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
11070696|NCT01417000|EG001|Reported Event|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
11070697|NCT01417026|BG000|Baseline|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
11070698|NCT01417026|BG001|Baseline|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
11227004|NCT02379091|OG003|Outcome|Namilumab 150 mg/mL|Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227005|NCT02379091|EG000|Reported Event|Placebo|Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227006|NCT02379091|EG001|Reported Event|Namilumab 20 mg/mL|Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227007|NCT02379091|EG002|Reported Event|Namilumab 80 mg/mL|Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227008|NCT02379091|EG003|Reported Event|Namilumab 150 mg/mL|Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227009|NCT02379091|EG004|Reported Event|Placebo to Namilumab 150 mg/mL|Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 12; followed by Namilumab 150 mg/mL, SC injection, every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227010|NCT02379091|EG005|Reported Event|Namilumab to Namilumab 150 mg/mL|Namilumab 20 or 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 12; followed by namilumab 150 mg/mL, SC injection, every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
11227011|NCT02379117|BG000|Baseline|Crohn's Disease Patients|Patients with a diagnosis of Crohn's disease fitting the studies inclusion & exclusion criteria.
11070699|NCT01417026|BG002|Baseline|Total|Total of all reporting groups
11091813|NCT01536366|EG001|Reported Event|Repaglinide|Repaglinide 0.5 mg
11227012|NCT02379117|BG001|Baseline|Healthy Volunteers|For healthy volunteers the studies exclusion criteria apply.
11227013|NCT02379117|BG002|Baseline|Total|Total of all reporting groups
11227014|NCT02379117|FG000|Participant Flow|Crohn's Disease Patients|Patients with a diagnosis of Crohn's disease fitting the studies inclusion & exclusion criteria.
11227015|NCT02379117|FG001|Participant Flow|Healthy Volunteers|For healthy volunteers the studies exclusion criteria apply.
11227016|NCT02379117|OG000|Outcome|Crohn's Disease Patients|Patients with a diagnosis of Crohn's disease fitting the studies inclusion & exclusion criteria.
11227017|NCT02379117|OG001|Outcome|Healthy Volunteers|For healthy volunteers the studies exclusion criteria apply.
11227018|NCT02379117|EG000|Reported Event|Crohn's Disease Patients|Patients with a diagnosis of Crohn's disease fitting the studies inclusion & exclusion criteria.
11227019|NCT02379117|EG001|Reported Event|Healthy Volunteers|For healthy volunteers the studies exclusion criteria apply.
11227020|NCT02379195|BG000|Baseline|Arm A: TIL + IFNalpha|"The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy with cyclophosphamide 60 mg/kg on day -7 and -6 and fludarabine 25 mg/m2 on day -5 to day -1.~TIL infusion: The maximum number of expanded TILs are infused over 30-45 min on day 0~Interleukin-2: Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days)~Peginterferon alfa-2b: Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14."
11070700|NCT01417026|FG000|Participant Flow|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
11070701|NCT01417026|FG001|Participant Flow|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
11070702|NCT01417026|OG000|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
11070703|NCT01417026|OG001|Outcome|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
11070704|NCT01417026|EG000|Reported Event|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
11070705|NCT01417026|EG001|Reported Event|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
11070706|NCT01417078|BG000|Baseline|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
11070707|NCT01417078|FG000|Participant Flow|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
11070708|NCT01417078|OG000|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
11070709|NCT01417078|OG001|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration
11070710|NCT01417078|OG001|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration.
11070711|NCT01417078|EG000|Reported Event|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
11070712|NCT01417104|BG000|Baseline|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
11070713|NCT01417104|BG001|Baseline|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
11070714|NCT01417104|BG002|Baseline|Total|Total of all reporting groups
11070715|NCT01417104|FG000|Participant Flow|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
11070716|NCT01417104|FG001|Participant Flow|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
11070717|NCT01417104|OG000|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
11070718|NCT01417104|OG001|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
11070719|NCT01417104|EG000|Reported Event|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
11070720|NCT01417104|EG001|Reported Event|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
11070721|NCT01417156|BG000|Baseline|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
11070722|NCT01417156|FG000|Participant Flow|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
11070723|NCT01417156|OG000|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
11070724|NCT01417156|EG000|Reported Event|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
11070725|NCT01417195|BG000|Baseline|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
11070726|NCT01417195|BG001|Baseline|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
11070727|NCT01417195|BG002|Baseline|Total|Total of all reporting groups
11070728|NCT01417195|FG000|Participant Flow|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
11070729|NCT01417195|FG001|Participant Flow|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
11070730|NCT01417195|OG000|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
11070731|NCT01417195|OG001|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
11070732|NCT01417195|OG001|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
11070733|NCT01417195|EG000|Reported Event|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
11070734|NCT01417195|EG001|Reported Event|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
11070735|NCT01417234|BG000|Baseline|SNaP® Wound Care System|SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
11070736|NCT01417234|FG000|Participant Flow|SNaP® Wound Care System|SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
11070737|NCT01417234|OG000|Outcome|SNaP® Wound Care System|SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
11070738|NCT01417234|EG000|Reported Event|SNaP® Wound Care System|SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
11070739|NCT01417455|BG000|Baseline|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
11070740|NCT01417455|BG001|Baseline|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
11070741|NCT01417455|BG002|Baseline|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
11070742|NCT01417455|BG003|Baseline|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
11070743|NCT01417455|BG004|Baseline|Ankylosing Spondylitis|Active Ankylosing Spondylitis
11070744|NCT01417455|BG005|Baseline|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
11070745|NCT01417455|BG006|Baseline|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
11070746|NCT01417455|BG007|Baseline|Controls|Healthy donors age and sex matched to the patients
11070747|NCT01417455|BG008|Baseline|Total|Total of all reporting groups
11070748|NCT01417455|FG000|Participant Flow|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
11070749|NCT01417455|FG001|Participant Flow|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
11070750|NCT01417455|FG002|Participant Flow|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
11070751|NCT01417455|FG003|Participant Flow|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
11070752|NCT01417455|FG004|Participant Flow|Ankylosing Spondylitis|Active Ankylosing Spondylitis
11070753|NCT01417455|FG005|Participant Flow|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
11227021|NCT02379195|FG000|Participant Flow|Arm A: TIL + IFNalpha|"The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy with cyclophosphamide 60 mg/kg on day -7 and -6 and fludarabine 25 mg/m2 on day -5 to day -1.~TIL infusion: The maximum number of expanded TILs are infused over 30-45 min on day 0~Interleukin-2: Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days)~Peginterferon alfa-2b: Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14."
11227022|NCT02379195|OG000|Outcome|Arm A: TIL + IFNalpha|"The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy with cyclophosphamide 60 mg/kg on day -7 and -6 and fludarabine 25 mg/m2 on day -5 to day -1.~TIL infusion: The maximum number of expanded TILs are infused over 30-45 min on day 0~Interleukin-2: Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days)~Peginterferon alfa-2b: Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14."
11070754|NCT01417455|FG006|Participant Flow|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
11070755|NCT01417455|FG007|Participant Flow|Controls|Healthy donors age and sex matched to the patients
11070756|NCT01417455|OG000|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
11070757|NCT01417455|OG001|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
11070758|NCT01417455|OG002|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
11070759|NCT01417455|OG003|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
11070760|NCT01417455|OG004|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
11070761|NCT01417455|OG005|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
11070762|NCT01417455|OG006|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
11070763|NCT01417455|OG007|Outcome|Controls|Healthy donors age and sex matched to the patients
11070764|NCT01417455|EG000|Reported Event|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
11070765|NCT01417455|EG001|Reported Event|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
11070766|NCT01417455|EG002|Reported Event|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
11070767|NCT01417455|EG003|Reported Event|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
11070768|NCT01417455|EG004|Reported Event|Ankylosing Spondylitis|Active Ankylosing Spondylitis
11070769|NCT01417455|EG005|Reported Event|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
11070770|NCT01417455|EG006|Reported Event|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
11070771|NCT01417455|EG007|Reported Event|Controls|Healthy donors age and sex matched to the patients - Healthy donors were not under any therapy therefore they were not at risk and Adverse effects were not assessed.
11070772|NCT01417481|BG000|Baseline|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
11070773|NCT01417481|BG001|Baseline|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
11070774|NCT01417481|BG002|Baseline|Total|Total of all reporting groups
11070775|NCT01417481|FG000|Participant Flow|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
11070776|NCT01417481|FG001|Participant Flow|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
11070777|NCT01417481|OG000|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
11070778|NCT01417481|OG001|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
11070779|NCT01417481|EG000|Reported Event|Glycine|Patients received a daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
11070780|NCT01417481|EG001|Reported Event|Placebo|Patients received a daily oral supplement of sugar glass at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
11070781|NCT01417741|BG000|Baseline|Standard Therapy Only|"Patients will not receive acupuncture. Standard anti-emetic therapy will be given.~Children ages 3-9 undergoing tonsillectomy with or without adenoidectomy were the population studied in both arms."
11070782|NCT01417741|BG001|Baseline|Acupuncture Plus Standard Therapy|"Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.~Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist"
11070783|NCT01417741|BG002|Baseline|Total|Total of all reporting groups
11070784|NCT01417741|FG000|Participant Flow|Standard Therapy Only|"Patients will not receive acupuncture. Standard anti-emetic therapy will be given.~Standard anti -emetic therapy at our institution for children having a T and A consists of Ondansetron 0.15 mg/kg and dexamethasone 0.25mg/kg up to 10 mg."
11070785|NCT01417741|FG001|Participant Flow|Acupuncture Plus Standard Therapy|"Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.~Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist"
11070786|NCT01417741|OG000|Outcome|Standard Therapy Only|"Patients will not receive acupuncture. Standard anti-emetic therapy will be given.~In phase i and 11 recovery units 26 patients ( 34.7 %) of 75 patients in this arm experienced Nausea and or vomiting.~on POD 1; 37 patients or 54% experienced nausea or vomiting"
11070787|NCT01417741|OG001|Outcome|Acupuncture Plus Standard Therapy|"Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.~Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist~In phase 1 and 11 recovery units: 6 patients ( 7%) of 86 experienced nausea or vomiting On POD one: 31 or 43% experienced PONV"
11070788|NCT01417741|EG000|Reported Event|Standard Therapy Only ( AE Group)|Patients will not receive acupuncture. Standard anti-emetic therapy will be given.
11070789|NCT01417741|EG001|Reported Event|Acupuncture Plus Standard Therapy|"Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.~Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist"
11070790|NCT01417780|BG000|Baseline|AB103 0.25 mg/kg|AB103 0.25 mg/kg administered as a single IV infusion
11070791|NCT01417780|BG001|Baseline|AB103 0.5 mg/kg|AB103 0.5 mg/kg administered as a single IV infusion
11070792|NCT01417780|BG002|Baseline|Placebo|Normal saline (0.9% sodium chloride) administered as a single IV infusion
11070793|NCT01417780|BG003|Baseline|Total|Total of all reporting groups
11070794|NCT01417780|FG000|Participant Flow|AB103 0.25 mg/kg|AB103 0.25 mg/kg administered as a single IV infusion
11070795|NCT01417780|FG001|Participant Flow|AB103 0.5 mg/kg|AB103 0.5 mg/kg administered as a single IV infusion
11070796|NCT01417780|FG002|Participant Flow|Placebo|Normal saline (0.9% sodium chloride) administered as a single IV infusion
11070797|NCT01417780|OG000|Outcome|AB103 0.25 mg/kg|AB103 0.25 mg/kg administered as a single IV infusion
11070798|NCT01417780|OG001|Outcome|AB103 0.5 mg/kg|AB103 0.5 mg/kg administered as a single IV infusion
11070799|NCT01417780|OG002|Outcome|Placebo|Normal saline (0.9% sodium chloride) administered as a single IV infusion
11070800|NCT01417780|EG000|Reported Event|AB103 0.25 mg/kg|AB103 0.25 mg/kg administered as a single IV infusion
11070801|NCT01417780|EG001|Reported Event|AB103 0.5 mg/kg|AB103 0.5 mg/kg administered as a single IV infusion
11070802|NCT01417780|EG002|Reported Event|Placebo|Normal saline (0.9% sodium chloride) administered as a single IV infusion
11070803|NCT01417936|BG000|Baseline|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
11070804|NCT01417936|FG000|Participant Flow|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
11070805|NCT01417936|OG000|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
11070806|NCT01417936|EG000|Reported Event|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
11070807|NCT01418001|BG000|Baseline|Level 1: Pazopanib 400 mg QD Gemcitabine and Docetaxel in Com|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
11070808|NCT01418001|FG000|Participant Flow|Pazopanib 400 mg QD|Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
11070809|NCT01418001|OG000|Outcome|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
11070810|NCT01418001|OG000|Outcome|Pazopanib 400 mg QD|Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
11070811|NCT01418001|EG000|Reported Event|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
11070812|NCT01418209|BG000|Baseline|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
11091814|NCT01536379|BG000|Baseline|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
11335672|NCT03554629|OG003|Outcome|30 Second LOW RR 4 With Actual Respiration Rate of 6|False Low RR for 15- 29 seconds with CCSF gas sample for capnography measurement.
11070813|NCT01418209|BG001|Baseline|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
11070814|NCT01418209|BG002|Baseline|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
11070815|NCT01418209|BG003|Baseline|Total|Total of all reporting groups
11070816|NCT01418209|FG000|Participant Flow|Low-dose 17-ß-Estradiol With Progesterone Taper|Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably. The 8 week estradiol treatment is followed 14 days (2 weeks) of progesterone taper (as medroxy-progesterone 10 mg/day).
11227023|NCT02379195|EG000|Reported Event|Arm A: TIL + IFNalpha|"The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy with cyclophosphamide 60 mg/kg on day -7 and -6 and fludarabine 25 mg/m2 on day -5 to day -1.~TIL infusion: The maximum number of expanded TILs are infused over 30-45 min on day 0~Interleukin-2: Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days)~Peginterferon alfa-2b: Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14."
11227024|NCT02379221|BG000|Baseline|Injectable / Topical|"Half of the face is injected with local anesthesia, the other half is treated with topical anesthesia by randomized method.~Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection~Topical: 4% Topicaine gel"
11227025|NCT02379221|FG000|Participant Flow|Injectable / Topical|"Half of the face is injected with local anesthesia, the other half is treated with topical anesthesia per randomized method.~Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection~Topical: 4% Topicaine gel"
11227026|NCT02379221|OG000|Outcome|Injectable|"Half of the face is injected with local anesthesia per randomized method.~Injectable: 2% lidocaine 1:100k epinephrine nerve block injection~Topical: 4% Topicaine gel"
11227027|NCT02379221|OG001|Outcome|Topical|"Half of the face is treated with topical anesthesia per randomized method~Topical application of 20% benzocaine~4% lidocaine gel"
11227028|NCT02379221|OG000|Outcome|Upper Lip|2% lidocaine and 1:100k epinephrine injected to the upper lip
11227029|NCT02379221|OG001|Outcome|Lower Lip|2% lidocaine and 1:100K epi injected to the lower lip
11227030|NCT02379221|OG000|Outcome|Upper Lip|20% benzocaine to the upper lip
11091815|NCT01536379|BG001|Baseline|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
11091816|NCT01536379|BG002|Baseline|Total|Total of all reporting groups
11227031|NCT02379221|OG001|Outcome|Lower Lip|20% benzocaine to the lower lip
11227032|NCT02379221|EG000|Reported Event|Injectable / Topical|"One side of face is injected with local anesthesia, the other side is treated with topical anesthesia per randomization.~Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection~Topical: 4% Topicaine gel"
11227033|NCT02379273|BG000|Baseline|Hybrid L24 Pivotal Study Subjects.|Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
11227034|NCT02379273|FG000|Participant Flow|Hybrid L24 Pivotal Study Subjects.|Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
11227035|NCT02379273|OG000|Outcome|Hybrid L24 Pivotal Study Subjects.|Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
11227036|NCT02379273|EG000|Reported Event|Hybrid L24 Pivotal Study Subjects.|Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
11227037|NCT02379442|BG000|Baseline|BMSC|Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e^6 MSC/kg for up to 12 doses
11227038|NCT02379442|FG000|Participant Flow|BMSC|Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e^6 MSC/kg for up to 12 doses
11227039|NCT02379442|OG000|Outcome|BMSC|Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e^6 MSC/kg for up to 12 doses
11227040|NCT02379442|EG000|Reported Event|BMSC|Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e^6 MSC/kg for up to 12 doses
11227041|NCT02379637|BG000|Baseline|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
11227042|NCT02379637|BG001|Baseline|B Placebo|"Placebo~Placebo"
11227043|NCT02379637|BG002|Baseline|Total|Total of all reporting groups
11227044|NCT02379637|FG000|Participant Flow|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine, capsules, 800 mg 3 times daily"
11227045|NCT02379637|FG001|Participant Flow|B Placebo|"Placebo~Placebo, matching capsules three times daily"
11227046|NCT02379637|OG000|Outcome|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
11227047|NCT02379637|OG001|Outcome|B Placebo|"Placebo~Placebo"
11227048|NCT02379637|EG000|Reported Event|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
11227049|NCT02379637|EG001|Reported Event|B Placebo|"Placebo~Placebo"
11335673|NCT03554629|EG000|Reported Event|FlexiCare (Nasal)|"8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant.~Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following"
11070817|NCT01418209|FG001|Participant Flow|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
11070818|NCT01418209|FG002|Participant Flow|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
11070819|NCT01418209|OG000|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
11070820|NCT01418209|OG001|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
11070821|NCT01418209|OG002|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
11070822|NCT01418209|EG000|Reported Event|Low-dose 17-ß-estradiol|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
11070823|NCT01418209|EG001|Reported Event|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
11070824|NCT01418209|EG002|Reported Event|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
11070825|NCT01418339|BG000|Baseline|Aripiprazole|Aripiprazole was administered orally once a week (QW) for 8 weeks in a double-blind manner. Participants randomized to aripiprazole received aripiprazole tablets at a starting dose of 52.5 milligrams (mg) QW on Day 0. At Week 1, according to the investigator's discretion based on efficacy and tolerability, the dose of aripiprazole could remain at 52.5 mg QW or could be increased to 77.5 mg QW. The dose could be increased to 110 mg QW as early as Week 2. For the remainder of the study (up to Week 8), the dose was to be adjusted up and down among these three dose levels, as determined by the investigator.
11070826|NCT01418339|BG001|Baseline|Placebo|Participants randomized to placebo received aripiprazole-matching placebo tablet, orally, QW for 8 weeks in a double-blind manner
11070827|NCT01418339|BG002|Baseline|Total|Total of all reporting groups
11070828|NCT01418339|FG000|Participant Flow|Aripiprazole|Aripiprazole was administered orally once a week (QW) for 8 weeks in a double-blind manner. Participants randomized to aripiprazole received aripiprazole tablets at a starting dose of 52.5 milligrams (mg) QW on Day 0. At Week 1, according to the investigator's discretion based on efficacy and tolerability, the dose of aripiprazole could remain at 52.5 mg QW or could be increased to 77.5 mg QW. The dose could be increased to 110 mg QW as early as Week 2. For the remainder of the study (up to Week 8), the dose was to be adjusted up and down among these three dose levels, as determined by the investigator.
11070829|NCT01418339|FG001|Participant Flow|Placebo|Participants randomized to placebo received aripiprazole-matching placebo tablet, orally, QW for 8 weeks in a double-blind manner.
11070830|NCT01418339|OG000|Outcome|Aripiprazole|Aripiprazole was administered orally once a week (QW) for 8 weeks in a double-blind manner. Participants randomized to aripiprazole received aripiprazole tablets at a starting dose of 52.5 milligrams (mg) QW on Day 0. At Week 1, according to the investigator's discretion based on efficacy and tolerability, the dose of aripiprazole could remain at 52.5 mg QW or could be increased to 77.5 mg QW. The dose could be increased to 110 mg QW as early as Week 2. For the remainder of the study (up to Week 8), the dose was to be adjusted up and down among these three dose levels, as determined by the investigator.
11070831|NCT01418339|OG001|Outcome|Placebo|Participants randomized to placebo received aripiprazole-matching placebo tablet, orally, QW for 8 weeks in a double-blind manner.
11070832|NCT01418339|EG000|Reported Event|Aripiprazole|Aripiprazole was administered orally once a week (QW) for 8 weeks in a double-blind manner. Participants randomized to aripiprazole received aripiprazole tablets at a starting dose of 52.5 milligrams (mg) QW on Day 0. At Week 1, according to the investigator's discretion based on efficacy and tolerability, the dose of aripiprazole could remain at 52.5 mg QW or could be increased to 77.5 mg QW. The dose could be increased to 110 mg QW as early as Week 2. For the remainder of the study (up to Week 8), the dose was to be adjusted up and down among these three dose levels, as determined by the investigator.
11070833|NCT01418339|EG001|Reported Event|Placebo|Participants randomized to placebo received aripiprazole-matching placebo tablet, orally, QW for 8 weeks in a double-blind manner.
11070834|NCT01418352|BG000|Baseline|Aripiprazole 52.5 mg|Participants received aripiprazole 52.5 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070835|NCT01418352|BG001|Baseline|Aripiprazole 77.5 mg|Participants received aripiprazole 77.5 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11227050|NCT02379728|BG000|Baseline|PrenaBelt|"Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.~A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227051|NCT02379728|BG001|Baseline|Control|"Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.~A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227052|NCT02379728|BG002|Baseline|Total|Total of all reporting groups
11227053|NCT02379728|FG000|Participant Flow|PrenaBelt|"Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227054|NCT02379728|FG001|Participant Flow|PrenaBelt With Body Position Sensor|"Participants will be instructed to use the PrenaBelt (with integrated body position sensor (BPS)) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227055|NCT02379728|FG002|Participant Flow|Control|"Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.~Participants will be followed by study personnel through the remainder of pregnancy and delivery.~sham-PrenaBelt: The PrenaBelt can be easily converted into a sham-PrenaBelt for research purposes by removing the hard balls from its pockets or exchanging these hard balls for soft balls so it cannot provide pressure points, i.e., positional therapy function. The sham-PrenaBelt looks, fits, and feels like the PrenaBelt but cannot provide positional therapy."
11227056|NCT02379728|FG003|Participant Flow|Control With Body Position Sensor (BPS)|"Participants will be instructed to use the sham-PrenaBelt (with integrated BPS) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227057|NCT02379728|OG000|Outcome|PrenaBelt|"Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.~A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227058|NCT02379728|OG001|Outcome|Control|"Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.~A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227059|NCT02379728|OG000|Outcome|Maternity Personnel|At completion of recruitment, the maternity personnel completing the device introduction sessions completed a questionnaire eliciting their training level, professional experience, and perspectives on session duration, delivery method, and challenges.
11227060|NCT02379728|OG000|Outcome|PrenaBelt With Body Position Sensor|"Participants will be instructed to use the PrenaBelt (with integrated body position sensor (BPS)) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227061|NCT02379728|OG001|Outcome|Control With Body Position Sensor (BPS)|"Participants will be instructed to use the sham-PrenaBelt (with integrated BPS) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227062|NCT02379728|EG000|Reported Event|PrenaBelt|"Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.~A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11227063|NCT02379728|EG001|Reported Event|Control|"Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.~A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep.~Participants will be followed by study personnel through the remainder of pregnancy and delivery."
11335674|NCT03554629|EG001|Reported Event|Hudson RCI /TeleFlex(Nasal)|"8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant.~Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following"
11070836|NCT01418352|BG002|Baseline|Aripiprazole 110 mg|Participants received aripiprazole 110 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070837|NCT01418352|BG003|Baseline|Matching Placebo|Participants received aripiprazole matching placebo tablets, orally, once weekly for the 8-week Double-blind Treatment Period.
11070838|NCT01418352|BG004|Baseline|Total|Total of all reporting groups
11070839|NCT01418352|FG000|Participant Flow|Aripiprazole 52.5 mg|Participants received aripiprazole 52.5 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070840|NCT01418352|FG001|Participant Flow|Aripiprazole 77.5 mg|Participants received aripiprazole 77.5 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070841|NCT01418352|FG002|Participant Flow|Aripiprazole 110 mg|Participants received aripiprazole 110 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070842|NCT01418352|FG003|Participant Flow|Matching Placebo|Participants received aripiprazole matching placebo, tablets, orally, once weekly for the 8-week Double-blind Treatment Period.
11070843|NCT01418352|OG000|Outcome|Aripiprazole 52.5 mg|Participants received aripiprazole 52.5 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070844|NCT01418352|OG001|Outcome|Aripiprazole 77.5 mg|Participants received aripiprazole 77.5 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070845|NCT01418352|OG002|Outcome|Aripiprazole 110 mg|Participants received aripiprazole 110 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070846|NCT01418352|OG003|Outcome|Matching Placebo|Participants received aripiprazole matching placebo, tablets, orally, once weekly for the 8-week Double-blind Treatment Period.
11070847|NCT01418352|EG000|Reported Event|Aripiprazole 52.5 mg|Participants received aripiprazole 52.5 mg, tablet, orally, once weekly for the 8-week Double-blind Treatment Period.
11070848|NCT01418352|EG001|Reported Event|Aripiprazole 77.5 mg|Participants received aripiprazole 77.5 mg, tablet, orally once weekly for the 8-week Double-blind Treatment Period.
11070849|NCT01418352|EG002|Reported Event|Aripiprazole 110 mg|Participants received aripiprazole 110 mg, tablet, orally once weekly for the 8-week Double-blind Treatment Period.
11070850|NCT01418352|EG003|Reported Event|Matching Placebo|Participants received aripiprazole matching placebo, tablets, orally, once weekly for the 8-week Double-blind Treatment Period.
11070851|NCT01418365|BG000|Baseline|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
11070852|NCT01418365|BG001|Baseline|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
11070853|NCT01418365|BG002|Baseline|Total|Total of all reporting groups
11070854|NCT01418365|FG000|Participant Flow|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
11070855|NCT01418365|FG001|Participant Flow|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
11070856|NCT01418365|OG000|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
11070857|NCT01418365|OG001|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
11070858|NCT01418365|EG000|Reported Event|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
11070859|NCT01418365|EG001|Reported Event|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
11070860|NCT01418378|BG000|Baseline|Sigma CR 150|Subjects who received a Sigma CR 150 implant
11070861|NCT01418378|BG001|Baseline|Sigma CR|Subjects who received a Sigma CR implant
11070862|NCT01418378|BG002|Baseline|Total|Total of all reporting groups
11070863|NCT01418378|FG000|Participant Flow|Sigma CR 150|Subjects who received a Sigma CR 150 implant
11070864|NCT01418378|FG001|Participant Flow|Sigma CR|Subjects who received a Sigma CR implant
11070865|NCT01418378|OG000|Outcome|Sigma CR 150|Subjects who received a Sigma CR 150 implant
11070866|NCT01418378|OG001|Outcome|Sigma CR|Subjects who received a Sigma CR implant
11070867|NCT01418378|EG000|Reported Event|CR 150|Subjects who received a Sigma CR150 implant
11070868|NCT01418378|EG001|Reported Event|C-RET|Subjects who received a Sigma CR implant
11070869|NCT01418482|BG000|Baseline|Mepilex Border Ag|Mepilex Border Ag, ( a silver dressing)
11070870|NCT01418482|FG000|Participant Flow|Mepilex Border Ag|Mepilex Border Ag, a silver dressing
11070871|NCT01418482|OG000|Outcome|Mepilex Border Ag|Mepilex Border Ag
11070872|NCT01418482|EG000|Reported Event|Mepilex Border Ag|Mepilex Border Ag
11070873|NCT01418703|BG000|Baseline|Standard Control to Range (sCTR)|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
11070874|NCT01418703|BG001|Baseline|Enhanced Control to Range (eCTR)|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
11070875|NCT01418703|BG002|Baseline|Total|Total of all reporting groups
11070876|NCT01418703|FG000|Participant Flow|Open-Loop First, Then sCTR Closed-Loop|"Completed open-loop, then sCTR (Standard Control to Range ) Closed-Loop admission.~The two modules of sCTR are the SSM (safety supervision module) and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM (continuous glucose monitor) and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g. body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII (continuous subcutaneous insulin infusion) parameters."
11070877|NCT01418703|FG001|Participant Flow|sCTR Closed-Loop First, Then Open-Loop|"Participants completed sCTR Closed-Loop admission, then completed open-loop admission.~The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour."
11070878|NCT01418703|FG002|Participant Flow|Open-Loop First, Then eCTR Closed-Loop|"Participants completed open-loop admission, then completed eCTR (Enhanced Control to Range) closed-loop admission.~The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC (model predictive control) algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the clinical research center (CRC) kitchen but automatically calculated by eCTR."
11070879|NCT01418703|FG003|Participant Flow|eCTR Closed-Loop First, Then Open-Loop|"Participants completed open-loop admission, then completed eCTR closed-loop admission.~The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR."
11070880|NCT01418703|OG000|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
11070881|NCT01418703|OG001|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
11070882|NCT01418703|EG000|Reported Event|Open-Loop|This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
11091817|NCT01536379|FG000|Participant Flow|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
11335675|NCT03554629|EG002|Reported Event|Salter Lab (Nasal)|"8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant.~Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following"
11070883|NCT01418703|EG001|Reported Event|sCTR Closed-Loop Control|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
11070884|NCT01418703|EG002|Reported Event|eCTR Closed-Loop Control|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
11070885|NCT01418937|BG000|Baseline|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
11070886|NCT01418937|FG000|Participant Flow|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
11070887|NCT01418937|OG000|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
11070888|NCT01418937|EG000|Reported Event|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
11070889|NCT01419015|BG000|Baseline|20-mm TF-TAVR|Patients with symptomatic severe aortic stenosis received a 20 mm SAPIEN XT valve through the transfemoral procedure.
11070890|NCT01419015|FG000|Participant Flow|20-mm TF-TAVR|Patients with symptomatic severe aortic stenosis received a 20 mm SAPIEN XT valve through the transfemoral procedure.
11070891|NCT01419015|OG000|Outcome|TAVI-TF Approach|Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
11070892|NCT01419015|EG000|Reported Event|TAVI-TF Approach|Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
11070893|NCT01419028|BG000|Baseline|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
11070894|NCT01419028|FG000|Participant Flow|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
11070895|NCT01419028|OG000|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
11070896|NCT01419028|EG000|Reported Event|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
11070897|NCT01419171|BG000|Baseline|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
11070898|NCT01419171|FG000|Participant Flow|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
11070899|NCT01419171|OG000|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
11070900|NCT01419171|EG000|Reported Event|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
11070901|NCT01419184|BG000|Baseline|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11070902|NCT01419184|BG001|Baseline|Vancomycin|Vancomycin was reconstituted per the manufacturer's instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11070903|NCT01419184|BG002|Baseline|Total|Total of all reporting groups
11070904|NCT01419184|FG000|Participant Flow|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11070905|NCT01419184|FG001|Participant Flow|Vancomycin|Vancomycin was reconstituted per the manufacturer's instructions and was dosed per investigator's discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion.
11070906|NCT01419184|OG000|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11070907|NCT01419184|OG001|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer's instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11070908|NCT01419184|EG000|Reported Event|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11070909|NCT01419184|EG001|Reported Event|Vancomycin|Vancomycin was reconstituted per the manufacturer's instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
11227064|NCT02379858|BG000|Baseline|Alvimopan (Entereg)|"Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.~Alvimopan: Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal."
11227065|NCT02379858|BG001|Baseline|Suger Pill (Control)|"Placebo, 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.~Placebo: Placebo (sugar pill-will be the same size and color as the Alvimopan capsule), 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal."
11227066|NCT02379858|BG002|Baseline|Total|Total of all reporting groups
11227067|NCT02379858|FG000|Participant Flow|Alvimopan (Entereg)|"Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.~Alvimopan: Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal."
11227068|NCT02379858|FG001|Participant Flow|Suger Pill (Control)|"Placebo, 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.~Placebo: Placebo (sugar pill-will be the same size and color as the Alvimopan capsule), 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal."
11227069|NCT02379858|OG000|Outcome|Alvimopan (Entereg)|"Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.~Alvimopan: Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal."
11227070|NCT02379858|OG001|Outcome|Suger Pill (Control)|"Placebo, 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.~Placebo: Placebo (sugar pill-will be the same size and color as the Alvimopan capsule), 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal."
11227071|NCT02379858|EG000|Reported Event|Alvimopan (Entereg)|"Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.~Alvimopan: Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal."
11227072|NCT02379858|EG001|Reported Event|Suger Pill (Control)|"Placebo, 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.~Placebo: Placebo (sugar pill-will be the same size and color as the Alvimopan capsule), 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal."
11070910|NCT01419197|BG000|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
11335676|NCT03554629|EG003|Reported Event|Medtronic Filterline (Nasal)|"8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant.~Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following"
11070911|NCT01419197|BG001|Baseline|Treatment of Physician's Choice|Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
11070912|NCT01419197|BG002|Baseline|Total|Total of all reporting groups
11070913|NCT01419197|FG000|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
11070914|NCT01419197|FG001|Participant Flow|Treatment of Physician's Choice|Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and human epidermal growth factor receptor 2 (HER2)-directed therapy.
11070915|NCT01419197|OG000|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
11070916|NCT01419197|OG001|Outcome|Treatment of Physician's Choice|Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
11070917|NCT01419197|EG000|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
11070918|NCT01419197|EG001|Reported Event|Treatment of Physician's Choice (TPC)|Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
11070919|NCT01419197|EG002|Reported Event|Trastuzumab Emtansine - Post TPC Treatment Switch|Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
11070920|NCT01419236|BG000|Baseline|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
11070921|NCT01419236|BG001|Baseline|Placebo|Placebo solution applied topically once daily for 16 weeks.
11070922|NCT01419236|BG002|Baseline|Total|Total of all reporting groups
10887630|NCT00501891|OG000|Outcome|Bevacizumab and Metromonic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
11070923|NCT01419236|FG000|Participant Flow|Testosterone Solution 2%|Testosterone solution 2% [60 milligrams (mg) applied topically once daily with a potential 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day] for 16 weeks.
11070924|NCT01419236|FG001|Participant Flow|Placebo|Placebo solution applied topically once daily for 16 weeks.
11070925|NCT01419236|OG000|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
11070926|NCT01419236|OG001|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
11070927|NCT01419236|EG000|Reported Event|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
11070928|NCT01419236|EG001|Reported Event|Placebo|Placebo solution applied topically once daily for 16 weeks.
11070929|NCT01419249|BG000|Baseline|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070930|NCT01419249|BG001|Baseline|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070931|NCT01419249|BG002|Baseline|Total|Total of all reporting groups
11070932|NCT01419249|FG000|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070933|NCT01419249|FG001|Participant Flow|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070934|NCT01419249|OG000|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070935|NCT01419249|OG001|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070936|NCT01419249|OG000|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070937|NCT01419249|EG000|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070938|NCT01419249|EG001|Reported Event|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
11070939|NCT01419275|BG000|Baseline|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
11070940|NCT01419275|FG000|Participant Flow|Moyamoya|Participants with Moyamoya disease received arterial spin label magnetic resonance imaging (MRI) with xenon contrast agent.
11070941|NCT01419275|OG000|Outcome|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
11070942|NCT01419275|EG000|Reported Event|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
11070943|NCT01419314|BG000|Baseline|LE Splints Group|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
11070944|NCT01419314|BG001|Baseline|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
11070945|NCT01419314|BG002|Baseline|Total|Total of all reporting groups
11070946|NCT01419314|FG000|Participant Flow|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
11070947|NCT01419314|FG001|Participant Flow|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
11070948|NCT01419314|OG000|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
11070949|NCT01419314|OG001|Outcome|Splint Liner|Night time application of lower extremity splint liner
11070950|NCT01419314|OG000|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
11070951|NCT01419314|OG001|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
11070952|NCT01419314|OG000|Outcome|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
11070953|NCT01419314|OG001|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.
11070954|NCT01419314|EG000|Reported Event|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
11070955|NCT01419314|EG001|Reported Event|Splint Liner|Night time application of lower extremity splint liner
11070956|NCT01419535|BG000|Baseline|Mifepristone, Then Placebo|"Participants first received Mifepristone 50mg tablet every six hours for nine days. After a washout period of no fewer than 6 but no more than 8 weeks, they then received Placebo tablet (matching mifepristone 50 mg) every six hours for nine days.~Mifepristone: Mifepristone 50mg tablet by mouth every six hours for nine days.~Placebo: Placebo (matching mifepristone 50mg tablet) by mouth every six hours for nine days."
11070957|NCT01419535|BG001|Baseline|Placebo, Then Mifepristone|"Participants first received Placebo tablet (matching mifepristone 50 mg) every six hours for nine days. After a washout period of no fewer than 6 but no more than 8 weeks, they then received Mifepristone 50 mg tablet every six hours for nine days.~Mifepristone: Mifepristone 50mg tablet by mouth every six hours for nine days.~Placebo: Placebo (matching mifepristone 50mg tablet) by mouth every six hours for nine days."
11070958|NCT01419535|BG002|Baseline|Total|Total of all reporting groups
11070959|NCT01419535|FG000|Participant Flow|Mifepristone, Then Placebo|"Participants first received Mifepristone 50mg tablet every six hours for nine days. After a washout period of no fewer than 6 but no more than 8 weeks, they then received Placebo tablet (matching mifepristone 50 mg) every six hours for nine days.~Mifepristone: Mifepristone 50mg tablet by mouth every six hours for nine days.~Placebo: Placebo (matching mifepristone 50mg tablet) by mouth every six hours for nine days."
11070960|NCT01419535|FG001|Participant Flow|Placebo, Then Mifepristone|"Participants first received Placebo tablet (matching mifepristone 50 mg) every six hours for nine days. After a washout period of no fewer than 6 but no more than 8 weeks, they then received Mifepristone 50 mg tablet every six hours for nine days.~Mifepristone: Mifepristone 50mg tablet by mouth every six hours for nine days.~Placebo: Placebo (matching mifepristone 50mg tablet) by mouth every six hours for nine days."
11070961|NCT01419535|OG000|Outcome|Post-mifepristone|All subjects tested after mifepristone administration, compared to baseline
11070962|NCT01419535|OG001|Outcome|Post-placebo|all subjects tested after placebo administration, compared to baseline
11070963|NCT01419535|EG000|Reported Event|Post-mifepristone|All subjects tested after mifepristone administration, compared to baseline
11070964|NCT01419535|EG001|Reported Event|Post-placebo|all subjects tested after placebo administration, compared to baseline
11070965|NCT01419626|BG000|Baseline|Negative Control Group (Toothbrushing Only)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
11070966|NCT01419626|BG001|Baseline|Device Control Group (Toothbrushing, Device + Water)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
11070967|NCT01419626|BG002|Baseline|Test Group (Toothbrushing, Device+ Oil-containing Mouthrinse)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
11070968|NCT01419626|BG003|Baseline|Total|Total of all reporting groups
11070969|NCT01419626|FG000|Participant Flow|Negative Control Group (Toothbrushing Only)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
11070970|NCT01419626|FG001|Participant Flow|Device Control Group (Toothbrushing, Device + Water)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
11227073|NCT02379923|BG000|Baseline|Crossing of Coronary Artery CTO|This is a single arm intent to treat study. A subject is considered enrolled when the subject has given informed consent and meets all inclusion and exclusion criteria, including angiographic inclusion and exclusion criteria, which includes an attempt to cross the target lesion with an investigational device (ASAHI PTCA Guidewire or ASAHI Corsair Microcatheter). Clinical evaluation up to hospital discharge is conducted on all enrolled subjects. The purpose of the clinical follow-up is to determine if the subject has experienced or is experiencing any adverse events.
11227074|NCT02379923|FG000|Participant Flow|Crossing of Coronary Artery CTO|This is a single arm intent to treat study. A subject is considered enrolled when the subject has given informed consent and meets all inclusion and exclusion criteria, including angiographic inclusion and exclusion criteria, which includes an attempt to cross the target lesion with an investigational device (ASAHI PTCA Guidewire or ASAHI Corsair Microcatheter). Clinical evaluation up to hospital discharge is conducted on all enrolled subjects. The purpose of the clinical follow-up is to determine if the subject has experienced or is experiencing any adverse events.
11227075|NCT02379923|OG000|Outcome|Crossing of Coronary Artery CTO|This is a single arm intent to treat study. A subject is considered enrolled when the subject has given informed consent and meets all inclusion and exclusion criteria, including angiographic inclusion and exclusion criteria, which includes an attempt to cross the target lesion with an investigational device (ASAHI PTCA Guidewire or ASAHI Corsair Microcatheter). Clinical evaluation up to hospital discharge is conducted on all enrolled subjects. The purpose of the clinical follow-up is to determine if the subject has experienced or is experiencing any adverse events.
11227076|NCT02379923|OG000|Outcome|Antegrade Only|Subjects where only an antegrade crossing techinique was used.
11227077|NCT02379923|OG001|Outcome|Retrograde Only|Subjects where only a retrograde crossing technique was used
11227078|NCT02379923|OG002|Outcome|Antegrade and Retrograde|Subjects were both antegrade and retrograde techniques were used
11227079|NCT02379923|EG000|Reported Event|Crossing of Coronary Artery CTO|"This is a single arm intent to treat study. A subject is considered enrolled when the subject has given informed consent and meets all inclusion and exclusion criteria, including angiographic inclusion and exclusion criteria, which includes an attempt to cross the target lesion with an investigational device (ASAHI PTCA Guidewire or ASAHI Corsair Microcatheter). Clinical evaluation up to hospital discharge is conducted on all enrolled subjects. The purpose of the clinical follow-up is to determine if the subject has experienced or is experiencing any adverse events.~Crossing of Coronary Artery CTO: Standard angiographic procedures will be followed for this study. The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used."
11227080|NCT02380183|BG000|Baseline|Intervention|"Civco needle guidance device will be used while the nerve block is performed.~Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed."
11227081|NCT02380183|BG001|Baseline|Standard of Care|Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
11227082|NCT02380183|BG002|Baseline|Total|Total of all reporting groups
11227083|NCT02380183|FG000|Participant Flow|Intervention|"Civco needle guidance device will be used while the nerve block is performed.~Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed."
11227084|NCT02380183|FG001|Participant Flow|Standard of Care|Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
11227085|NCT02380183|OG000|Outcome|Intervention|"Civco needle guidance device will be used while the nerve block is performed.~Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed."
11227086|NCT02380183|OG001|Outcome|Standard of Care|Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
11070971|NCT01419626|FG002|Participant Flow|Test Group (Toothbrushing, Device+ Oil-containing Mouthrinse)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
11227087|NCT02380183|EG000|Reported Event|Intervention|"Civco needle guidance device will be used while the nerve block is performed.~Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed."
11227088|NCT02380183|EG001|Reported Event|Standard of Care|Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
11227089|NCT02380248|BG000|Baseline|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
11070972|NCT01419626|OG000|Outcome|Negative Control Group (Toothbrushing Only)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
11070973|NCT01419626|OG001|Outcome|Device Control Group (Toothbrushing, Device + Water)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
11070974|NCT01419626|OG002|Outcome|Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
11070975|NCT01419626|EG000|Reported Event|Negative Control Group (Toothbrushing Only)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
11070976|NCT01419626|EG001|Reported Event|Device Control Group (Toothbrushing, Device + Water)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
11227090|NCT02380248|FG000|Participant Flow|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID (4 times/day) in each eye for 90 days
11227091|NCT02380248|OG000|Outcome|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
11227092|NCT02380248|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11227093|NCT02380248|EG001|Reported Event|Systane|All subjects exposed to study treatment
11227094|NCT02380261|BG000|Baseline|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
11227095|NCT02380261|FG000|Participant Flow|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
11227096|NCT02380261|OG000|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
11227097|NCT02380261|EG000|Reported Event|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
11227098|NCT02380287|BG000|Baseline|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
11227099|NCT02380287|BG001|Baseline|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
11227100|NCT02380287|BG002|Baseline|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
11227101|NCT02380287|BG003|Baseline|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
11227102|NCT02380287|BG004|Baseline|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
11227103|NCT02380287|BG005|Baseline|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
11227104|NCT02380287|BG006|Baseline|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
11227105|NCT02380287|BG007|Baseline|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
11227106|NCT02380287|BG008|Baseline|Total|Total of all reporting groups
11227107|NCT02380287|FG000|Participant Flow|Cohort no.1|"This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included.~humanized monoclonal antibody against human IL-17"
11070977|NCT01419626|EG002|Reported Event|Test Group (Toothbrushing, Device+ Oil-containing Mouthrinse)|Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
11070978|NCT01419639|BG000|Baseline|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
11070979|NCT01419639|FG000|Participant Flow|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
11070980|NCT01419639|OG000|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
11070981|NCT01419639|EG000|Reported Event|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
11070982|NCT01419665|BG000|Baseline|GP2013|Experimental Type: Biological/Vaccine
11070983|NCT01419665|BG001|Baseline|Rituximab|Comparator Type: Biological/Vaccine
11070984|NCT01419665|BG002|Baseline|Total|Total of all reporting groups
11070985|NCT01419665|FG000|Participant Flow|GP2013|Experimental Type: Biological/Vaccine
11070986|NCT01419665|FG001|Participant Flow|Rituximab|Comparator Type: Biological/Vaccine
11070987|NCT01419665|OG000|Outcome|GP2013|Experimental Type: Biological/Vaccine
11070988|NCT01419665|OG001|Outcome|Rituximab|Comparator Type: Biological/Vaccine
11070989|NCT01419665|EG000|Reported Event|Combination GP2013+CVP|Combination GP2013+CVP
11070990|NCT01419665|EG001|Reported Event|Combination MabThera+CVP|Combination MabThera+CVP
11070991|NCT01419665|EG002|Reported Event|Maintenance GP2013|Maintenance GP2013
11070992|NCT01419665|EG003|Reported Event|Maintenance MabThera|Maintenance MabThera
11070993|NCT01419717|BG000|Baseline|Denosumab|Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
11070994|NCT01419717|FG000|Participant Flow|Denosumab|Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
11070995|NCT01419717|OG000|Outcome|Denosumab|Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
11070996|NCT01419717|EG000|Reported Event|Denosumab|Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
11091818|NCT01536379|FG001|Participant Flow|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
11070997|NCT01419769|BG000|Baseline|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
11070998|NCT01419769|FG000|Participant Flow|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
11070999|NCT01419769|OG000|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
11071000|NCT01419769|EG000|Reported Event|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
11071001|NCT01419795|BG000|Baseline|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11071002|NCT01419795|BG001|Baseline|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11071003|NCT01419795|BG002|Baseline|Total|Total of all reporting groups
11071004|NCT01419795|FG000|Participant Flow|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11071005|NCT01419795|FG001|Participant Flow|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11071006|NCT01419795|OG000|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11071007|NCT01419795|OG001|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11071008|NCT01419795|EG000|Reported Event|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11071009|NCT01419795|EG001|Reported Event|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11071010|NCT01419977|BG000|Baseline|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
11071011|NCT01419977|BG001|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
11071012|NCT01419977|BG002|Baseline|Total|Total of all reporting groups
11071013|NCT01419977|FG000|Participant Flow|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
11071014|NCT01419977|FG001|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
11227108|NCT02380287|FG001|Participant Flow|Cohort no.2|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3.~humanized monoclonal antibody against human IL-17"
11227109|NCT02380287|FG002|Participant Flow|Cohort no.3|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4.~humanized monoclonal antibody against human IL-17"
11227110|NCT02380287|FG003|Participant Flow|Cohort no.4|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5.~humanized monoclonal antibody against human IL-17"
11227111|NCT02380287|FG004|Participant Flow|Cohort no.5|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6.~humanized monoclonal antibody against human IL-17"
11071015|NCT01419977|OG000|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
11071016|NCT01419977|OG001|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
11071017|NCT01419977|EG000|Reported Event|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
11071018|NCT01419977|EG001|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
11071019|NCT01420016|BG000|Baseline|Prioritized Clinical Decision Support|The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).
11071020|NCT01420016|BG001|Baseline|Usual Care|Usual care.
11071021|NCT01420016|BG002|Baseline|Total|Total of all reporting groups
11071022|NCT01420016|FG000|Participant Flow|Prioritized Clinical Decision Support- Primary Analysis|After entry of BP data, relevant EHR data were extracted from the EHR, encrypted, and processed through Web-based clinical algorithms that (a) determined if the patient met intervention eligibility criteria, (b) identified evidence-based treatment options for any uncontrolled CVR factors, and (c) prioritized treatment recommendations based on potential CV risk reduction. CV risk factors addressed in these study participants were control of lipids, BP, weight, tobacco, and appropriate aspirin use. Personalized treatment recommendations were printed given to PCP and patient immediately before the visit.
11071023|NCT01420016|FG001|Participant Flow|Usual Care- Primary Analysis|Patients and providers at control clinics did not have access to the prioritized clinical decision support system.
11091819|NCT01536379|OG000|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
11071024|NCT01420016|FG002|Participant Flow|Prioritized Clinical Decision Support- Safety Analysis|The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).
11071025|NCT01420016|FG003|Participant Flow|Usual Care- Safety Analysis|Patients and providers at control clinics did not have access to the CV Wizard clinical decision support system.
11071026|NCT01420016|OG000|Outcome|Prioritized Clinical Decision Support|The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).
11071027|NCT01420016|OG001|Outcome|Usual Care|Usual care.
11071028|NCT01420016|EG000|Reported Event|Prioritized Clinical Decision Support|The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).
11071029|NCT01420016|EG001|Reported Event|Usual Care|Patients and providers at control clinics did not have access to the CV Wizard clinical decision support system.
11071030|NCT01420068|BG000|Baseline|Enalapril|No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of enalapril based on their weight: low weight (≥20 to <50 kg) participants - starting dose 2.5 mg with optional titration to 5 and then 10 mg; mid weight (≥50 to <80 kg) participants - starting dose 5 mg with optional titration to 10 and then 20 mg; high weight (≥80 to ≤150 kg) participants - starting dose 10 mg with optional titration to 20 and then 40 mg.
11071031|NCT01420068|BG001|Baseline|Aliskiren|No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of aliskiren based on their weight: low weight (≥20 to <50 kg) participants - starting dose 37.5 mg with optional titration to 75 and then 150 mg; mid weight (≥50 to <80 kg) participants - starting dose 75 mg with optional titration to 150 and then 300 mg; high weight (≥80 to ≤150 kg) participants - starting dose 150 mg with optional titration to 300 and then 600 mg.
11071032|NCT01420068|BG002|Baseline|Total|Total of all reporting groups
11071033|NCT01420068|FG000|Participant Flow|Enalapril|No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of enalapril based on their weight: low weight (≥20 to <50 kg) participants - starting dose 2.5 mg with optional titration to 5 and then 10 mg; mid weight (≥50 to <80 kg) participants - starting dose 5 mg with optional titration to 10 and then 20 mg; high weight (≥80 to ≤150 kg) participants - starting dose 10 mg with optional titration to 20 and then 40 mg.
11071034|NCT01420068|FG001|Participant Flow|Aliskiren|No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of aliskiren based on their weight: low weight (≥20 to <50 kg) participants - starting dose 37.5 mg with optional titration to 75 and then 150 mg; mid weight (≥50 to <80 kg) participants - starting dose 75 mg with optional titration to 150 and then 300 mg; high weight (≥80 to ≤150 kg) participants - starting dose 150 mg with optional titration to 300 and then 600 mg.
11091820|NCT01536379|OG001|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
11071035|NCT01420068|OG000|Outcome|Enalapril|No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of enalapril based on their weight: low weight (≥20 to <50 kg) participants - starting dose 2.5 mg with optional titration to 5 and then 10 mg; mid weight (≥50 to <80 kg) participants - starting dose 5 mg with optional titration to 10 and then 20 mg; high weight (≥80 to ≤150 kg) participants - starting dose 10 mg with optional titration to 20 and then 40 mg.
11071036|NCT01420068|OG001|Outcome|Aliskiren|No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of aliskiren based on their weight: low weight (≥20 to <50 kg) participants - starting dose 37.5 mg with optional titration to 75 and then 150 mg; mid weight (≥50 to <80 kg) participants - starting dose 75 mg with optional titration to 150 and then 300 mg; high weight (≥80 to ≤150 kg) participants - starting dose 150 mg with optional titration to 300 and then 600 mg.
11071037|NCT01420068|EG000|Reported Event|Enalapril|No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of enalapril based on their weight: low weight (≥20 to <50 kg) participants - starting dose 2.5 mg with optional titration to 5 and then 10 mg; mid weight (≥50 to <80 kg) participants - starting dose 5 mg with optional titration to 10 and then 20 mg; high weight (≥80 to ≤150 kg) participants - starting dose 10 mg with optional titration to 20 and then 40 mg.
11071038|NCT01420068|EG001|Reported Event|Aliskiren|No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of aliskiren based on their weight: low weight (≥20 to <50 kg) participants - starting dose 37.5 mg with optional titration to 75 and then 150 mg; mid weight (≥50 to <80 kg) participants - starting dose 75 mg with optional titration to 150 and then 300 mg; high weight (≥80 to ≤150 kg) participants - starting dose 150 mg with optional titration to 300 and then 600 mg.
11071039|NCT01420081|BG000|Baseline|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
11071040|NCT01420081|BG001|Baseline|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071041|NCT01420081|BG002|Baseline|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
11071042|NCT01420081|BG003|Baseline|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071043|NCT01420081|BG004|Baseline|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071044|NCT01420081|BG005|Baseline|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071045|NCT01420081|BG006|Baseline|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11227112|NCT02380287|FG005|Participant Flow|Cohort no.6|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7.~humanized monoclonal antibody against human IL-17"
11335677|NCT03554629|EG004|Reported Event|WestMed (Oral/Nasal) RCI /TeleFlex(Nasal)|"8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant.~Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following"
11071046|NCT01420081|BG007|Baseline|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071047|NCT01420081|BG008|Baseline|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071048|NCT01420081|BG009|Baseline|Total|Total of all reporting groups
11071049|NCT01420081|FG000|Participant Flow|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, once daily (QD) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
11071050|NCT01420081|FG001|Participant Flow|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071051|NCT01420081|FG002|Participant Flow|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
11071052|NCT01420081|FG003|Participant Flow|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071053|NCT01420081|FG004|Participant Flow|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, once weekly (Quaque, QW) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071054|NCT01420081|FG005|Participant Flow|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071055|NCT01420081|FG006|Participant Flow|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11227113|NCT02380287|FG006|Participant Flow|Cohort no.7|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 8 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 8.~humanized monoclonal antibody against human IL-17"
11227114|NCT02380287|FG007|Participant Flow|Cohort no.8|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level.~humanized monoclonal antibody against human IL-17"
11071056|NCT01420081|FG007|Participant Flow|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071057|NCT01420081|FG008|Participant Flow|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071058|NCT01420081|OG000|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071059|NCT01420081|OG001|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071060|NCT01420081|OG000|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
11227115|NCT02380287|OG000|Outcome|Cohort 1 + Cohort 2|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
11227116|NCT02380287|OG001|Outcome|Cohort 3|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
11227117|NCT02380287|OG002|Outcome|Cohort 4|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
11071061|NCT01420081|OG001|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
11227118|NCT02380287|OG003|Outcome|Cohort 5|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
11227119|NCT02380287|OG004|Outcome|Cohort 6|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
11227120|NCT02380287|OG005|Outcome|Cohort 7|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
11071062|NCT01420081|OG002|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
11227121|NCT02380287|OG006|Outcome|Cohort 8|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
11227122|NCT02380287|OG000|Outcome|Cohort 1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
11227123|NCT02380287|OG001|Outcome|Cohort 2|This cohort includes subjects who received the same single dose of BCD-085 as in a Cohort 1 (0.05 mg/kg) subcutaneously since no grade 3/4 toxicity events were observed in Cohort 1 during follow-up period (7 days).
11227124|NCT02380287|OG002|Outcome|Cohort 3|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
11227125|NCT02380287|OG003|Outcome|Cohort 4|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
11227126|NCT02380287|OG004|Outcome|Cohort 5|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
11227127|NCT02380287|OG005|Outcome|Cohort 6|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
11227128|NCT02380287|OG006|Outcome|Cohort 7|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
11227129|NCT02380287|OG007|Outcome|Cohort 8|This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
11227130|NCT02380287|EG000|Reported Event|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
11227131|NCT02380287|EG001|Reported Event|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
11227132|NCT02380287|EG002|Reported Event|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
11227133|NCT02380287|EG003|Reported Event|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
11227134|NCT02380287|EG004|Reported Event|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
11227135|NCT02380287|EG005|Reported Event|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
11227136|NCT02380287|EG006|Reported Event|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
11227137|NCT02380287|EG007|Reported Event|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
11071063|NCT01420081|EG000|Reported Event|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
11227138|NCT02380612|BG000|Baseline|Experimental: All Participants (Within Patient Control)|All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated).
11227139|NCT02380612|FG000|Participant Flow|Experimental: All Participants (Within Patient Control)|Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. Each subject's study treatment area (burn injury) was divided into Area A and Area B before thee areas (A and B) were randomly assigned to receive CONTROL (grafting consistent with the pre-identified graft plan) or RECELL (RECELL-generated cell suspension applied over a graft more widely meshed than identified in the pre-specified graft plan).
11227140|NCT02380612|OG000|Outcome|RECELL-Treated|Wound received application of the RECELL-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (RECELL-treated).
11227141|NCT02380612|OG001|Outcome|Control|Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
11227142|NCT02380612|OG000|Outcome|All Subjects|Every subject received both interventions (RECELL and CONTROL)
11227143|NCT02380612|OG001|Outcome|CONTROL|Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
11227144|NCT02380612|EG000|Reported Event|Experimental: All Participants (Within Patient Control)|All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated).
11227145|NCT02380677|BG000|Baseline|Schedule 1 Cohort 1|"CRLX301 7.5 mg/m2 IV given every 3 weeks~CRLX301"
11227146|NCT02380677|BG001|Baseline|Schedule 1 Cohort 2|"CRLX301 15 mg/m2 IV given every 3 weeks~CRLX301"
11227147|NCT02380677|BG002|Baseline|Schedule 1 Cohort 3|"CRLX301 30 mg/m2 IV given every 3 weeks~CRLX301"
11227148|NCT02380677|BG003|Baseline|Schedule 1 Cohort 5|"CRLX301 60 mg/m2 IV given every 3 weeks~CRLX301"
11227149|NCT02380677|BG004|Baseline|Schedule 1 Cohort 6|"CRLX301 75 mg/m2 IV given every 3 weeks~CRLX301"
11227150|NCT02380677|BG005|Baseline|Schedule 1 Cohort 7|"CRLX301 90 mg/m2 IV given every 3 weeks~CRLX301"
11227151|NCT02380677|BG006|Baseline|Schedule 2 Cohort 1|"CRLX301 25 mg/m2 IV given weekly~CRLX301"
11227152|NCT02380677|BG007|Baseline|Schedule 2 Cohort 2|"CRLX301 35 mg/m2 IV given weekly~CRLX301"
11227153|NCT02380677|BG008|Baseline|Schedule 2 Cohort 3|"CRLX301 45 mg/m2 IV given weekly~CRLX301"
11227154|NCT02380677|BG009|Baseline|Schedule 2 Cohort 4|"CRLX301 54 mg/m2 IV given weekly~CRLX301"
11227155|NCT02380677|BG010|Baseline|Schedule 2 Cohort 5|"CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off~CRLX301"
11227156|NCT02380677|BG011|Baseline|Phase 2a Expansion Cohort|"CRLX301 75mg/m2 IV given every 3 weeks~CRLX301"
11071064|NCT01420081|EG001|Reported Event|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071065|NCT01420081|EG002|Reported Event|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
11071066|NCT01420081|EG003|Reported Event|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071067|NCT01420081|EG004|Reported Event|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW (Quaque [Once Weekly]) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071068|NCT01420081|EG005|Reported Event|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071069|NCT01420081|EG006|Reported Event|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071070|NCT01420081|EG007|Reported Event|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11071071|NCT01420081|EG008|Reported Event|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
11227157|NCT02380677|BG012|Baseline|Total|Total of all reporting groups
11071072|NCT01420146|BG000|Baseline|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
11071073|NCT01420146|FG000|Participant Flow|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
11071074|NCT01420146|OG000|Outcome|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
11227158|NCT02380677|FG000|Participant Flow|Schedule 1 Cohort 1|"CRLX301 7.5 mg/m2 IV given every 3 weeks~CRLX301"
11227159|NCT02380677|FG001|Participant Flow|Schedule 1 Cohort 2|"CRLX301 15 mg/m2 IV given every 3 weeks~CRLX301"
11071075|NCT01420146|EG000|Reported Event|Zr89-trastuzumab PET/CT|"Zr89-trastuzumab PET/CT single arm~Zr89-trastuzumab: trastuzumab labelled with zirconium 89 for PET/CT"
11071076|NCT01420289|BG000|Baseline|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
11071077|NCT01420289|BG001|Baseline|Excercise|Walking on a graded treadmill for 45 minutes once daily
11071078|NCT01420289|BG002|Baseline|Total|Total of all reporting groups
11071079|NCT01420289|FG000|Participant Flow|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
11071080|NCT01420289|FG001|Participant Flow|Excercise|Walking on a graded treadmill for 45 minutes once daily
11071081|NCT01420289|OG000|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
11071082|NCT01420289|OG001|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
11071083|NCT01420289|EG000|Reported Event|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
11071084|NCT01420289|EG001|Reported Event|Excercise|Walking on a graded treadmill for 45 minutes once daily
11071085|NCT01420536|BG000|Baseline|Canine Guidance, Then Bilateral Balanced Occlusion|"Canine guidance: Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92); Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions"
11071086|NCT01420536|BG001|Baseline|Bilateral Balanced Occlusion Then Canine Guidance|"Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions; Canine guidance: Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92);"
11071087|NCT01420536|BG002|Baseline|Total|Total of all reporting groups
11071088|NCT01420536|FG000|Participant Flow|Canine Guidance, Then Bilateral Balanced Occlusion|"Canine guidance: Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92); Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions"
11227160|NCT02380677|FG002|Participant Flow|Schedule 1 Cohort 3|"CRLX301 30 mg/m2 IV given every 3 weeks~CRLX301"
11071089|NCT01420536|FG001|Participant Flow|Bilateral Balanced Occlusion, Then Canine Guidance|"Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions; Canine guidance: Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)."
11071090|NCT01420536|OG000|Outcome|Canine Guidance|"Canine guidance: Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)"
11071091|NCT01420536|OG001|Outcome|Bilateral Balanced Occlusion|Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
11071092|NCT01420536|OG000|Outcome|Canine Guidance|"Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)"
11071093|NCT01420536|OG001|Outcome|Bilateral Balanced Occlusion|Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
11071094|NCT01420536|EG000|Reported Event|Canine Guidance|"Complete dentures adjusted with mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)"
11071095|NCT01420536|EG001|Reported Event|Bilateral Balanced Occlusion|Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
11071096|NCT01420549|BG000|Baseline|Rosuvastatin + Ezetimibe|"Participants received Rosuvastatin 10 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was <100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Rosuvastatin 20 mg+ Ezetimibe 10mg tablet orally once daily for more 4 weeks.~Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.: Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation."
11071097|NCT01420549|BG001|Baseline|Simvastatin + Ezetimibe|"Participants received Simvastatin 20 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was <100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Simvastatin 40 mg + Ezetimibe 10mg tablet orally once daily for more 4 weeks.~Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.: Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation."
11071098|NCT01420549|BG002|Baseline|Total|Total of all reporting groups
11071099|NCT01420549|FG000|Participant Flow|Rosuvastatin + Ezetimibe|"Participants received Rosuvastatin 10 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was <100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Rosuvastatin 20 mg+ Ezetimibe 10mg tablet orally once daily for more 4 weeks.~Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.: Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation."
11071100|NCT01420549|FG001|Participant Flow|Simvastatin + Ezetimibe|"Participants received Simvastatin 20 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was <100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Simvastatin 40 mg + Ezetimibe 10mg tablet orally once daily for more 4 weeks.~Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.: Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation."
11071101|NCT01420549|OG000|Outcome|Rosuvastatin + Ezetimibe|"Participants received Rosuvastatin 10 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was <100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Rosuvastatin 20 mg+ Ezetimibe 10mg tablet orally once daily for more 4 weeks.~Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.: Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation."
11071102|NCT01420549|OG001|Outcome|Simvastatin + Ezetimibe|"Participants received Simvastatin 20 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was <100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Simvastatin 40 mg + Ezetimibe 10mg tablet orally once daily for more 4 weeks.~Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.: Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation."
11227161|NCT02380677|FG003|Participant Flow|Schedule 1 Cohort 5|"CRLX301 60 mg/m2 IV given every 3 weeks~CRLX301"
11071103|NCT01420549|EG000|Reported Event|Rosuvastatin + Ezetimibe|"Participants received Rosuvastatin 10 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was <100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Rosuvastatin 20 mg+ Ezetimibe 10mg tablet orally once daily for more 4 weeks.~Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.: Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation."
11091821|NCT01536379|EG000|Reported Event|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
11071104|NCT01420549|EG001|Reported Event|Simvastatin + Ezetimibe|"Participants received Simvastatin 20 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was <100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Simvastatin 40 mg + Ezetimibe 10mg tablet orally once daily for more 4 weeks.~Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.: Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation."
11071105|NCT01420627|BG000|Baseline|Adagen/EZN-2279|"Patients started on Adagen and crossed over to experimental EZN-2279 treatment after at least a 3 week Lead-in Period on Adagen~EZN-2279: Weekly administration of EZN-2279 via IM injection~Adagen"
11071106|NCT01420627|FG000|Participant Flow|Adagen/EZN-2279|Patients started on Adagen and crossed over to experimental EZN-2279 treatment
11071107|NCT01420627|OG000|Outcome|EZN-2279|Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
11071108|NCT01420627|OG000|Outcome|Adagen|Patients received Adagen during the Lead-in Period
11071109|NCT01420627|OG001|Outcome|EZN-2279|Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
11071110|NCT01420627|OG000|Outcome|EZN-2279 Treatment Period|Patients who completed at least a 3-week Adagen Lead-in Period and entered the 21-week Treatment Period
11071111|NCT01420627|EG000|Reported Event|Adagen|Patients received Adagen during the Lead-in Period (at least 3 weeks)
11071112|NCT01420627|EG001|Reported Event|EZN-2279|Patients received EZN-2279 after crossing over from Adagen
11071113|NCT01420653|BG000|Baseline|Maxigesic 325|"Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally~Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours"
11071114|NCT01420653|BG001|Baseline|Acetaminophen|"Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally~Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours"
11071115|NCT01420653|BG002|Baseline|Ibuprofen|"Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally~Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours."
11071116|NCT01420653|BG003|Baseline|Placebo|"Placebo tablets, every 6 hours, orally~Placebo: placebo, three tablets four times a day, with food for 48 hours"
11071117|NCT01420653|BG004|Baseline|Total|Total of all reporting groups
11071118|NCT01420653|FG000|Participant Flow|Maxigesic 325|"Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally~Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours"
11071119|NCT01420653|FG001|Participant Flow|Acetaminophen|"Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally~Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours"
11071120|NCT01420653|FG002|Participant Flow|Ibuprofen|"Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally~Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours."
11071121|NCT01420653|FG003|Participant Flow|Placebo|"Placebo tablets, every 6 hours, orally~Placebo: placebo, three tablets four times a day, with food for 48 hours"
11071122|NCT01420653|OG000|Outcome|Maxigesic 325|"Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally~Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours"
11071123|NCT01420653|OG001|Outcome|Acetaminophen|"Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally~Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours"
11071124|NCT01420653|OG002|Outcome|Ibuprofen|"Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally~Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours."
11071125|NCT01420653|OG003|Outcome|Placebo|"Placebo tablets, every 6 hours, orally~Placebo: placebo, three tablets four times a day, with food for 48 hours"
11071126|NCT01420653|EG000|Reported Event|Maxigesic 325|"Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally~Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours"
11071127|NCT01420653|EG001|Reported Event|Acetaminophen|"Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally~Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours"
11071128|NCT01420653|EG002|Reported Event|Ibuprofen|"Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally~Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours."
11071129|NCT01420653|EG003|Reported Event|Placebo|"Placebo tablets, every 6 hours, orally~Placebo: placebo, three tablets four times a day, with food for 48 hours"
11091822|NCT01536379|EG001|Reported Event|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
11091823|NCT01536392|BG000|Baseline|Arm 1: Transdermal Granisetron|8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.
11091824|NCT01536392|BG001|Baseline|Arm 2: Oral Ondansetron|8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
11091825|NCT01536392|BG002|Baseline|Total|Total of all reporting groups
11091826|NCT01536392|FG000|Participant Flow|Arm 1: Transdermal Granisetron|8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.
11091827|NCT01536392|FG001|Participant Flow|Arm 2: Oral Ondansetron|8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
11091828|NCT01536392|OG000|Outcome|Arm 1: Transdermal Granisetron|8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.
11071130|NCT01420679|BG000|Baseline|Pralatrexate Arm|Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride [NaCl]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m^2), could be reduced to 20 mg/m^2 with potential further reductions to 15 and 10 mg/m^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
11071131|NCT01420679|BG001|Baseline|Observation Arm|Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
11071132|NCT01420679|BG002|Baseline|Total|Total of all reporting groups
11071133|NCT01420679|FG000|Participant Flow|Pralatrexate Arm|Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride [NaCl]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m^2), could be reduced to 20 mg/m^2 with potential further reductions to 15 and 10 mg/m^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
11071134|NCT01420679|FG001|Participant Flow|Observation Arm|Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
11227162|NCT02380677|FG004|Participant Flow|Schedule 1 Cohort 6|"CRLX301 75 mg/m2 IV given every 3 weeks~CRLX301"
11227163|NCT02380677|FG005|Participant Flow|Schedule 1 Cohort 7|"CRLX301 90 mg/m2 IV given every 3 weeks~CRLX301"
11227164|NCT02380677|FG006|Participant Flow|Schedule 2 Cohort 1|"CRLX301 25 mg/m2 IV given weekly~CRLX301"
11227165|NCT02380677|FG007|Participant Flow|Schedule 2 Cohort 2|"CRLX301 35 mg/m2 IV given weekly~CRLX301"
11227166|NCT02380677|FG008|Participant Flow|Schedule 2 Cohort 3|"CRLX301 45 mg/m2 IV given weekly~CRLX301"
11227167|NCT02380677|FG009|Participant Flow|Schedule 2 Cohort 4|"CRLX301 54 mg/m2 IV given weekly~CRLX301"
11227168|NCT02380677|FG010|Participant Flow|Schedule 2 Cohort 5|"CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off~CRLX301"
11227169|NCT02380677|FG011|Participant Flow|Phase 2a Expansion Cohort|"CRLX301 75mg/m2 IV given every 3 weeks~CRLX301"
11227170|NCT02380677|OG000|Outcome|Schedule 1 Cohort 1|"CRLX301 7.5 mg/m2 IV given every 3 weeks~CRLX301"
11227171|NCT02380677|OG001|Outcome|Schedule 1 Cohort 2|"CRLX301 15 mg/m2 IV given every 3 weeks~CRLX301"
11227172|NCT02380677|OG002|Outcome|Schedule 1 Cohort 3|"CRLX301 30 mg/m2 IV given every 3 weeks~CRLX301"
11227173|NCT02380677|OG003|Outcome|Schedule 1 Cohort 5|"CRLX301 60 mg/m2 IV given every 3 weeks~CRLX301"
11227174|NCT02380677|OG004|Outcome|Schedule 1 Cohort 6|"CRLX301 75 mg/m2 IV given every 3 weeks~CRLX301"
11227175|NCT02380677|OG005|Outcome|Schedule 1 Cohort 7|"CRLX301 90 mg/m2 IV given every 3 weeks~CRLX301"
11227176|NCT02380677|OG006|Outcome|Schedule 2 Cohort 1|"CRLX301 25 mg/m2 IV given weekly~CRLX301"
11227177|NCT02380677|OG007|Outcome|Schedule 2 Cohort 2|"CRLX301 35 mg/m2 IV given weekly~CRLX301"
11227178|NCT02380677|OG008|Outcome|Schedule 2 Cohort 3|"CRLX301 45 mg/m2 IV given weekly~CRLX301"
11091829|NCT01536392|OG001|Outcome|Arm 2: Oral Ondansetron|8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
11091830|NCT01536392|EG000|Reported Event|Arm 1: Transdermal Granisetron|8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.
11227179|NCT02380677|OG009|Outcome|Schedule 2 Cohort 4|"CRLX301 54 mg/m2 IV given weekly~CRLX301"
11227180|NCT02380677|OG010|Outcome|Schedule 2 Cohort 5|CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off
11227181|NCT02380677|OG000|Outcome|Phase 2a Expansion Cohort|"CRLX301 75mg/m2 IV given every 3 weeks~CRLX301"
11227182|NCT02380677|OG010|Outcome|Schedule 2 Cohort 5|"CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off~CRLX301"
11227183|NCT02380677|OG011|Outcome|Phase 2a Expansion Cohort|"CRLX301 75mg/m2 IV given every 3 weeks~CRLX301"
11227184|NCT02380677|EG000|Reported Event|Schedule 1 Cohort 1|"CRLX301 7.5 mg/m2 IV given every 3 weeks~CRLX301"
11227185|NCT02380677|EG001|Reported Event|Schedule 1 Cohort 2|"CRLX301 15 mg/m2 IV given every 3 weeks~CRLX301"
11227186|NCT02380677|EG002|Reported Event|Schedule 1 Cohort 3|"CRLX301 30 mg/m2 IV given every 3 weeks~CRLX301"
11227187|NCT02380677|EG003|Reported Event|Schedule 1 Cohort 5|"CRLX301 60 mg/m2 IV given every 3 weeks~CRLX301"
11227188|NCT02380677|EG004|Reported Event|Schedule 1 Cohort 6|"CRLX301 75 mg/m2 IV given every 3 weeks~CRLX301"
11227189|NCT02380677|EG005|Reported Event|Schedule 1 Cohort 7|"CRLX301 90 mg/m2 IV given every 3 weeks~CRLX301"
11227190|NCT02380677|EG006|Reported Event|Schedule 2 Cohort 1|"CRLX301 25 mg/m2 IV given weekly~CRLX301"
11227191|NCT02380677|EG007|Reported Event|Schedule 2 Cohort 2|"CRLX301 35 mg/m2 IV given weekly~CRLX301"
11227192|NCT02380677|EG008|Reported Event|Schedule 2 Cohort 3|"CRLX301 45 mg/m2 IV given weekly~CRLX301"
11227193|NCT02380677|EG009|Reported Event|Schedule 2 Cohort 4|"CRLX301 54 mg/m2 IV given weekly~CRLX301"
11227194|NCT02380677|EG010|Reported Event|Schedule 2 Cohort 5|"CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off~CRLX301"
11227195|NCT02380677|EG011|Reported Event|Phase 2a Expansion Cohort|"CRLX301 75mg/m2 IV given every 3 weeks~CRLX301"
11227196|NCT02380690|BG000|Baseline|Peer Coach Assignment|"Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.~Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management."
11071135|NCT01420679|OG000|Outcome|Pralatrexate Arm|Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride [NaCl]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m^2), could be reduced to 20 mg/m^2 with potential further reductions to 15 and 10 mg/m^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
11071136|NCT01420679|OG001|Outcome|Observation Arm|Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
11071137|NCT01420679|EG000|Reported Event|Pralatrexate Arm|Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride [NaCl]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m^2), could be reduced to 20 mg/m^2 with potential further reductions to 15 and 10 mg/m^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
11071138|NCT01420679|EG001|Reported Event|Observation Arm|Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
11071139|NCT01420848|BG000|Baseline|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
11071140|NCT01420848|BG001|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
11071141|NCT01420848|BG002|Baseline|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
11071142|NCT01420848|BG003|Baseline|Total|Total of all reporting groups
11071143|NCT01420848|FG000|Participant Flow|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
11071144|NCT01420848|FG001|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
11071145|NCT01420848|FG002|Participant Flow|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
11071146|NCT01420848|OG000|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
11071147|NCT01420848|OG001|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
11071148|NCT01420848|OG002|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
11071149|NCT01420848|EG000|Reported Event|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
11071150|NCT01420848|EG001|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
11071151|NCT01420848|EG002|Reported Event|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
11227197|NCT02380690|BG001|Baseline|Control|"Veteran participants will attend a 2-hour class in pain basics and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management."
11071152|NCT01421017|BG000|Baseline|IMQ+RT|"This arm has been closed as of 6/4/2014.~Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Imiquimod"
11071153|NCT01421017|BG001|Baseline|CTX/IMQ/RT|"Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion~Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Imiquimod~Cyclophosphamide"
11227198|NCT02380690|BG002|Baseline|Total|Total of all reporting groups
11071154|NCT01421017|BG002|Baseline|CTX/RT|"For patients with only non-skin metastatic sites~First cycle (Cycle 1):~Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion~Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Cyclophosphamide"
11071155|NCT01421017|BG003|Baseline|Total|Total of all reporting groups
11071156|NCT01421017|FG000|Participant Flow|IMQ+RT|"This arm has been closed as of 6/4/2014.~Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Imiquimod"
11227199|NCT02380690|FG000|Participant Flow|Peer Coach Assignment|"Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.~Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management."
11227200|NCT02380690|FG001|Participant Flow|Control|"Veteran participants will attend a 2-hour class in pain basics and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management."
11227201|NCT02380690|OG000|Outcome|Peer Coach Assignment|"Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.~Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management."
11227202|NCT02380690|OG001|Outcome|Control|"Veteran participants will attend a 2-hour class in pain basics and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management."
11227203|NCT02380690|EG000|Reported Event|Peer Coach Assignment|"Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.~Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management."
11227204|NCT02380690|EG001|Reported Event|Control|"Veteran participants will attend a 2-hour class in pain basics and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management."
11227205|NCT02380703|BG000|Baseline|Aggression Prevention Training (APT)|"APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home.~Aggression Prevention Training (APT)"
11227206|NCT02380703|BG001|Baseline|Enhanced Usual Primary Care (EU-PC)|"EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers.~Enhanced Usual Primary Care (EU-PC)"
11227207|NCT02380703|BG002|Baseline|Total|Total of all reporting groups
11227208|NCT02380703|FG000|Participant Flow|Aggression Prevention Training (APT)|"APT will use active learning tools, including didactics, role-playing, and multimedia [eg, books and digital video disc (DVDs)] to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home.~Aggression Prevention Training (APT)"
11227209|NCT02380703|FG001|Participant Flow|Enhanced Usual Primary Care (EU-PC)|"EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers.~Enhanced Usual Primary Care (EU-PC)"
11227210|NCT02380703|OG000|Outcome|Aggression Prevention Training (APT)|"APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home.~Aggression Prevention Training (APT)"
11071157|NCT01421017|FG001|Participant Flow|CTX/IMQ/RT|"Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion~Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Imiquimod~Cyclophosphamide"
11227211|NCT02380703|OG001|Outcome|Enhanced Usual Primary Care (EU-PC)|"EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers.~Enhanced Usual Primary Care (EU-PC)"
11233692|NCT02430480|OG000|Outcome|1/Arm 1- Enzalutamide and Goserelin|"Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.~Goserelin: 10.8mg administered subcutaneously every 12 weeks (2 doses)~Enzalutamide: 160mg orally, daily for 24 weeks~mpMRI: Multiparametric MRI - One at baseline and after 6 months of treatment"
11233693|NCT02430480|OG000|Outcome|Grade 1|"Common Terminology Criteria for Adverse Events (CTCAE) v4~Grade 1 is Mild; asymptomatic or mild symptoms."
11227212|NCT02380703|EG000|Reported Event|Aggression Prevention Training (APT)|"APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home.~Aggression Prevention Training (APT)"
11227213|NCT02380703|EG001|Reported Event|Enhanced Usual Primary Care (EU-PC)|"EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers.~Enhanced Usual Primary Care (EU-PC)"
11227214|NCT02380742|BG000|Baseline|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point"
11227215|NCT02380742|BG001|Baseline|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point"
11227216|NCT02380742|BG002|Baseline|Total|Total of all reporting groups
11227217|NCT02380742|FG000|Participant Flow|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point"
11227218|NCT02380742|FG001|Participant Flow|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point"
11227219|NCT02380742|OG000|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point"
11227220|NCT02380742|OG001|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point"
11227221|NCT02380742|EG000|Reported Event|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point"
11227222|NCT02380742|EG001|Reported Event|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point"
11227223|NCT02380859|BG000|Baseline|Real Prism Adaptation|Participants were randomized to treatment prisms, designed to shift vertical orientation slightly by 1.5 degrees
11227224|NCT02380859|BG001|Baseline|Sham Prism Adaptation|Participants were randomized to placebo lenses that distorted vision without vertical shift.
11227225|NCT02380859|BG002|Baseline|Total|Total of all reporting groups
11091831|NCT01536392|EG001|Reported Event|Arm 2: Oral Ondansetron|8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
11227226|NCT02380859|FG000|Participant Flow|Real Prism Adaptation|Participants were randomized to undergo treatment that involved adaptation to 15º upward shifts in vision.
11227227|NCT02380859|FG001|Participant Flow|Sham Prism Adaptation|Participants were randomized to placebo lenses that distorted vision without vertical shift.
11227228|NCT02380859|OG000|Outcome|Real Prism Adaptation|Participants were randomized to undergo treatment that involved adaptation to 15º upward shifts in vision.
11227229|NCT02380859|OG001|Outcome|Sham Prism Adaptation|Participants were randomized to placebo lenses that distorted vision without vertical shift
11227230|NCT02380859|EG000|Reported Event|Real Prism Adaptation|Participants were randomized to undergo treatment that involved adaptation to 15º upward shifts in vision.
11227231|NCT02380859|EG001|Reported Event|Sham Prism Adaptation|Participants were randomized to placebo lenses that distorted vision without vertical shift.
11227232|NCT02381015|BG000|Baseline|Genetic Risk Score: Number Format|"Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.~Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number."
11227233|NCT02381015|BG001|Baseline|Genetic Risk Score: Number + Pictograph|"Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.~Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227234|NCT02381015|BG002|Baseline|Family History: Number Format|"Family History: Number Format Subjects receive family history risk in a number format.~Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227235|NCT02381015|BG003|Baseline|Family History: Number + Pictograph|"Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.~Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227236|NCT02381015|BG004|Baseline|Total|Total of all reporting groups
11227237|NCT02381015|FG000|Participant Flow|Genetic Risk Score: Number Format|"Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.~Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number."
11227238|NCT02381015|FG001|Participant Flow|Genetic Risk Score: Number + Pictograph|"Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.~Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227239|NCT02381015|FG002|Participant Flow|Family History: Number Format|"Family History: Number Format Subjects receive family history risk in a number format.~Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227240|NCT02381015|FG003|Participant Flow|Family History: Number + Pictograph|"Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.~Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227241|NCT02381015|OG000|Outcome|Genetic Risk Score: Number Format|"Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.~Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number."
11227242|NCT02381015|OG001|Outcome|Genetic Risk Score: Number + Pictograph|"Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.~Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227243|NCT02381015|OG002|Outcome|Family History: Number Format|"Family History: Number Format Subjects receive family history risk in a number format.~Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11091832|NCT01536405|BG000|Baseline|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
11227244|NCT02381015|OG003|Outcome|Family History: Number + Pictograph|"Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.~Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227245|NCT02381015|OG000|Outcome|Genetic Risk Score: Number Format|Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format. Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number. Data presented as linear relationship between told risk and immediate recall.
11227246|NCT02381015|OG001|Outcome|Genetic Risk Score: Number + Pictograph|Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format. Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group. Data presented as linear relationship between told risk and immediated recall.
11227247|NCT02381015|OG002|Outcome|Family History: Number Format|Family History: Number Format Subjects receive family history risk in a number format. Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group. Data presented as linear relationship between told risk and immediated recall.
11233694|NCT02430480|OG001|Outcome|Grade 2|Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.
11227248|NCT02381015|OG003|Outcome|Family History: Number + Pictograph|Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format. Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group. Data presented as linear relationship between told risk and immediated recall.
11227249|NCT02381015|OG000|Outcome|Genetic Risk Score: Number Format|Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format. Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number. Data presented as linear relationship between told risk and immediated recall.
11227250|NCT02381015|EG000|Reported Event|Genetic Risk Score: Number Format|"Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.~Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number."
11071158|NCT01421017|FG002|Participant Flow|CTX/RT|"For patients with only non-skin metastatic sites~First cycle (Cycle 1):~Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion~Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Cyclophosphamide"
11071159|NCT01421017|OG000|Outcome|IMQ+RT|"This arm has been closed as of 6/4/2014.~Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Imiquimod"
11071160|NCT01421017|OG001|Outcome|CTX/IMQ/RT|"Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion~Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Imiquimod~Cyclophosphamide"
11071161|NCT01421017|OG002|Outcome|CTX/RT|"For patients with only non-skin metastatic sites~First cycle (Cycle 1):~Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion~Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation~Cyclophosphamide"
11071162|NCT01421017|EG000|Reported Event|IMQ+RT|"This arm has been closed as of 6/4/2014.~Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation Imiquimod"
11227251|NCT02381015|EG001|Reported Event|Genetic Risk Score: Number + Pictograph|"Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.~Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227252|NCT02381015|EG002|Reported Event|Family History: Number Format|"Family History: Number Format Subjects receive family history risk in a number format.~Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11227253|NCT02381015|EG003|Reported Event|Family History: Number + Pictograph|"Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.~Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group."
11071163|NCT01421017|EG001|Reported Event|CTX/IMQ/RT|"Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.~Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation Imiquimod Cyclophosphamide"
11091833|NCT01536405|BG001|Baseline|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
11091834|NCT01536405|BG002|Baseline|Total|Total of all reporting groups
11071164|NCT01421017|EG002|Reported Event|CTX/RT|"For patients with only non-skin metastatic sites~First cycle (Cycle 1):~Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment~Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.~Radiation Cyclophosphamide"
11071165|NCT01421134|BG000|Baseline|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
11071166|NCT01421134|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo"
11071167|NCT01421134|BG002|Baseline|Total|Total of all reporting groups
11071168|NCT01421134|FG000|Participant Flow|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
11071169|NCT01421134|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
11071170|NCT01421134|OG000|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
11071171|NCT01421134|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo"
11071172|NCT01421134|EG000|Reported Event|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
11071173|NCT01421134|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11071174|NCT01421147|BG000|Baseline|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
11071175|NCT01421147|BG001|Baseline|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
11227254|NCT02381288|BG000|Baseline|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
11227255|NCT02381288|BG001|Baseline|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
11071176|NCT01421147|BG002|Baseline|Total|Total of all reporting groups
11071177|NCT01421147|FG000|Participant Flow|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
11227256|NCT02381288|BG002|Baseline|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
11227257|NCT02381288|BG003|Baseline|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
11071178|NCT01421147|FG001|Participant Flow|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
11071179|NCT01421147|OG000|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
11071180|NCT01421147|OG001|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
11071181|NCT01421147|EG000|Reported Event|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
11071182|NCT01421147|EG001|Reported Event|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
11071183|NCT01421186|BG000|Baseline|Part A: MOR03087 Biweekly Dose Escalation|Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
11071184|NCT01421186|BG001|Baseline|Part B: MOR03087 Weekly Dose Escalation|Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
11227258|NCT02381288|BG004|Baseline|Total|Total of all reporting groups
11227259|NCT02381288|FG000|Participant Flow|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
11227260|NCT02381288|FG001|Participant Flow|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
11227261|NCT02381288|FG002|Participant Flow|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
11227262|NCT02381288|FG003|Participant Flow|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
11227263|NCT02381288|OG000|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
11071185|NCT01421186|BG002|Baseline|Part C: MOR03087 Plus Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
11071186|NCT01421186|BG003|Baseline|Part D: MOR03087 Plus Pomalidomide + Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
11071187|NCT01421186|BG004|Baseline|Part E: MOR03087 Plus Lenalidomide + Dexamethasone|"Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).~Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle."
11071188|NCT01421186|BG005|Baseline|Total|Total of all reporting groups
11071189|NCT01421186|FG000|Participant Flow|Part A: MOR03087 Biweekly Dose Escalation|Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
11071190|NCT01421186|FG001|Participant Flow|Part B: MOR03087 Weekly Dose Escalation|Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
11071191|NCT01421186|FG002|Participant Flow|Part C: MOR03087 Plus Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
11071192|NCT01421186|FG003|Participant Flow|Part D: MOR03087 Plus Pomalidomide + Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
11227264|NCT02381288|OG001|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
11227265|NCT02381288|OG002|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
11071193|NCT01421186|FG004|Participant Flow|Part E: MOR03087 Plus Lenalidomide + Dexamethasone|"Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).~Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle."
11071194|NCT01421186|OG000|Outcome|Part A: MOR03087 Biweekly Dose Escalation|Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
11071195|NCT01421186|OG001|Outcome|Part B: MOR03087 Weekly Dose Escalation|Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
11071196|NCT01421186|OG002|Outcome|Part C: MOR03087 Plus Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
11071197|NCT01421186|OG003|Outcome|Part D: MOR03087 Plus Pomalidomide + Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
11071198|NCT01421186|OG004|Outcome|Part E: MOR03087 Plus Lenalidomide + Dexamethasone|"Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).~Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle."
11071199|NCT01421186|OG000|Outcome|Part C: MOR03087 Plus Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
11227266|NCT02381288|OG003|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
11227267|NCT02381288|OG000|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
11227268|NCT02381288|OG001|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
11227269|NCT02381288|OG002|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
11227270|NCT02381288|EG000|Reported Event|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
11227271|NCT02381288|EG001|Reported Event|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
11227272|NCT02381288|EG002|Reported Event|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
11227273|NCT02381288|EG003|Reported Event|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
11233695|NCT02430480|OG002|Outcome|Grade 3|Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
11233696|NCT02430480|EG000|Reported Event|1/Arm 1- Enzalutamide and Goserelin|"Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.~Goserelin: 10.8mg administered subcutaneously every 12 weeks (2 doses)~Enzalutamide: 160mg orally, daily for 24 weeks~mpMRI: Multiparametric MRI - One at baseline and after 6 months of treatment"
11091835|NCT01536405|FG000|Participant Flow|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
11227274|NCT02381392|BG000|Baseline|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
11227275|NCT02381392|BG001|Baseline|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
11227276|NCT02381392|BG002|Baseline|Total|Total of all reporting groups
11227277|NCT02381392|FG000|Participant Flow|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
11227278|NCT02381392|FG001|Participant Flow|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
11227279|NCT02381392|OG000|Outcome|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
11227280|NCT02381392|OG001|Outcome|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
11227281|NCT02381392|EG000|Reported Event|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
11227282|NCT02381392|EG001|Reported Event|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
11227283|NCT02381418|BG000|Baseline|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
11227284|NCT02381418|FG000|Participant Flow|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
11227285|NCT02381418|OG000|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
11071200|NCT01421186|OG001|Outcome|Part D: MOR03087 Plus Pomalidomide + Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
11071201|NCT01421186|OG002|Outcome|Part E: MOR03087 Plus Lenalidomide + Dexamethasone|"Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).~Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle."
11227286|NCT02381418|OG000|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 ~Trivalent influenza subunit vaccine Influvac: 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
11227287|NCT02381418|EG000|Reported Event|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
11227288|NCT02381678|BG000|Baseline|All Patients Enrolled in Study|The whole group included 225 enrolled subjects. All 225 subjects included in the FAS(Full Analysis Set).
11227289|NCT02381678|FG000|Participant Flow|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
11227290|NCT02381678|FG001|Participant Flow|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
11227291|NCT02381678|FG002|Participant Flow|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
11227292|NCT02381678|OG000|Outcome|One-arm Group Included All Enrolled Subjects|This group included total 225 enrolled participants
11227293|NCT02381678|EG000|Reported Event|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
11227294|NCT02381678|EG001|Reported Event|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
11227295|NCT02381678|EG002|Reported Event|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
11227296|NCT02381795|BG000|Baseline|Nasal Carbon Dioxide|"0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).~Nasal Carbon Dioxide"
11227297|NCT02381795|FG000|Participant Flow|Nasal Carbon Dioxide|"0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).~Nasal Carbon Dioxide"
11227298|NCT02381795|OG000|Outcome|Nasal Carbon Dioxide|"0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).~Nasal Carbon Dioxide"
11227299|NCT02381795|EG000|Reported Event|Nasal Carbon Dioxide|"0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).~Nasal Carbon Dioxide"
11233697|NCT02430818|BG000|Baseline|Ketamine|"Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).~ketamine"
11233698|NCT02430818|BG001|Baseline|Morphine|"Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).~morphine"
11233699|NCT02430818|BG002|Baseline|Total|Total of all reporting groups
11233700|NCT02430818|FG000|Participant Flow|Ketamine|"Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).~ketamine"
11233701|NCT02430818|FG001|Participant Flow|Morphine|"Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).~morphine"
11071202|NCT01421186|OG000|Outcome|4 mg/kg QW|Dosing at 4 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
11233702|NCT02430818|OG000|Outcome|Ketamine|We asked patients if they would use the study medication again for acute pain.
11233703|NCT02430818|OG001|Outcome|Morphine|We asked patients if they would use the study medication again for acute pain.
11233704|NCT02430818|OG000|Outcome|Ketamine|Number of participants with Adverse Events
11233705|NCT02430818|OG001|Outcome|Morphine|Number of participants with Adverse Events
11233706|NCT02430818|OG000|Outcome|Ketamine|"Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).~ketamine"
11233707|NCT02430818|OG001|Outcome|Morphine|"Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).~morphine"
11233708|NCT02430818|EG000|Reported Event|Ketamine|"Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).~ketamine"
11233709|NCT02430818|EG001|Reported Event|Morphine|"Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).~morphine"
11233710|NCT02430870|BG000|Baseline|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11233711|NCT02430870|BG001|Baseline|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11071203|NCT01421186|OG001|Outcome|8 mg/kg QW|Dosing at 8 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
11071204|NCT01421186|OG002|Outcome|16 mg/kg QW|Dosing at 16 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
11071205|NCT01421186|EG000|Reported Event|Part A: MOR03087 Biweekly Dose Escalation|Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
11071206|NCT01421186|EG001|Reported Event|Part B: MOR03087 Weekly Dose Escalation|"Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.~MOR03087: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E.."
11071207|NCT01421186|EG002|Reported Event|Part C: MOR03087 Plus Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
11071208|NCT01421186|EG003|Reported Event|Part D: MOR03087 Plus Pomalidomide + Dexamethasone|Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
11071209|NCT01421186|EG004|Reported Event|Part E: MOR03087 Plus Lenalidomide + Dexamethasone|"Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).~Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle."
11071210|NCT01421225|BG000|Baseline|Standard Insulin Pump Therapy First|"The subjects in this arm received Standard Insulin Pump therapy on day 1 followed by Closed-Loop Insulin therapy on day 2.~Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.~Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol."
11071211|NCT01421225|BG001|Baseline|Closed-Loop Insulin Therapy First|"The subjects in this arm receive closed-loop insulin therapy on day 1 followed by standard insulin pump therapy on day 2.~Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.~Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol."
11071212|NCT01421225|BG002|Baseline|Total|Total of all reporting groups
11071213|NCT01421225|FG000|Participant Flow|Standard Insulin Pump Therapy First|"The subjects in this arm received Standard Insulin Pump therapy on day 1 followed by Closed-Loop Insulin therapy on day 2.~Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.~Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol."
11071214|NCT01421225|FG001|Participant Flow|Closed-Loop Insulin Therapy First|"The subjects in this arm receive closed-loop insulin therapy on day 1 followed by standard insulin pump therapy on day 2.~Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.~Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol."
11071215|NCT01421225|OG000|Outcome|Standard Insulin Pump Therapy|Subjects will receive standard insulin pump therapy as per their usual home insulin protocol on day 1 or 2.
11071216|NCT01421225|OG001|Outcome|Closed-Loop Insulin Therapy|Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or 2.
11071217|NCT01421225|OG001|Outcome|Closed-Loop Insulin Therpay|Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or two.
11071218|NCT01421225|EG000|Reported Event|Standard Insulin Pump Therapy|Subjects will receive standard insulin pump therapy as per their usual home insulin protocol on day 1 or 2.
11071219|NCT01421225|EG001|Reported Event|Closed-Loop Insulin Therapy|Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or 2.
11071220|NCT01421277|BG000|Baseline|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
11349059|NCT04126343|BG003|Baseline|Treatment Sequence: BCA|Participants received Placebo, MXF, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11071221|NCT01421277|BG001|Baseline|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
11071222|NCT01421277|BG002|Baseline|Total|Total of all reporting groups
11071223|NCT01421277|FG000|Participant Flow|Participants Enrolled in Protocol Version (V)1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
11071224|NCT01421277|FG001|Participant Flow|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
11091836|NCT01536405|FG001|Participant Flow|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
11071225|NCT01421277|OG000|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
11071226|NCT01421277|OG001|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
11071227|NCT01421277|EG000|Reported Event|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
11071228|NCT01421277|EG001|Reported Event|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
11071229|NCT01421303|BG000|Baseline|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
11071230|NCT01421303|FG000|Participant Flow|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
11071231|NCT01421303|OG000|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
11071232|NCT01421303|EG000|Reported Event|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
11071233|NCT01421342|BG000|Baseline|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
11071234|NCT01421342|BG001|Baseline|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11071235|NCT01421342|BG002|Baseline|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11071236|NCT01421342|BG003|Baseline|Total|Total of all reporting groups
11071237|NCT01421342|FG000|Participant Flow|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
11071238|NCT01421342|FG001|Participant Flow|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11071239|NCT01421342|FG002|Participant Flow|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11227300|NCT02382016|BG000|Baseline|Macitentan 10 mg|Participants received Macitentan 10 milligram (mg) film-coated tablets orally once daily for 12 weeks in Double-blind treatment period.
11227301|NCT02382016|BG001|Baseline|Placebo|Participants received Macitentan matching placebo film-coated tablets orally once daily for 12 weeks in Double-blind treatment period.
11227302|NCT02382016|BG002|Baseline|Total|Total of all reporting groups
11227303|NCT02382016|FG000|Participant Flow|Macitentan 10 mg|Participants received Macitentan 10 milligram (mg) film-coated tablets orally once daily for 12 weeks in Double-blind treatment period. Participants who completed DB treatment period continued to receive macitentan 10 mg for 12 weeks (up to Week 24) in OL treatment period . Participants (who were randomized at French sites) who completed the core phase of the study as scheduled and opted to continue receiving OL study treatment continued to receive macitentan 10 mg in OLE period.
11233712|NCT02430870|BG002|Baseline|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11071240|NCT01421342|OG000|Outcome|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
11071241|NCT01421342|OG001|Outcome|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11071242|NCT01421342|OG002|Outcome|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11071243|NCT01421342|EG000|Reported Event|Switching: Bupropion-SR|"Switching: Bupropion-SR~Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11071244|NCT01421342|EG001|Reported Event|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR~Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11071245|NCT01421342|EG002|Reported Event|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole~Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
11071246|NCT01421355|BG000|Baseline|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
11071247|NCT01421355|FG000|Participant Flow|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
11071248|NCT01421355|OG000|Outcome|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
11071249|NCT01421355|EG000|Reported Event|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
11071250|NCT01421459|BG000|Baseline|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
11071251|NCT01421459|BG001|Baseline|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
11071252|NCT01421459|BG002|Baseline|Total|Total of all reporting groups
11227304|NCT02382016|FG001|Participant Flow|Placebo|Participants received Macitentan matching placebo film-coated tablets orally once daily for 12 weeks in Double-blind treatment period. Participants who completed DB treatment period were administered with macitentan 10 mg for 12 weeks (up to Week 24) in OL treatment period. Participants who were randomized at French sites who completed the core study as scheduled and opted to continue receiving OL study treatment continued to receive macitentan 10mg in OLE period.
11071253|NCT01421459|FG000|Participant Flow|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
11071254|NCT01421459|FG001|Participant Flow|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
11071255|NCT01421459|OG000|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
11071256|NCT01421459|OG001|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
11071257|NCT01421459|EG000|Reported Event|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
11071258|NCT01421459|EG001|Reported Event|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
11071259|NCT01421472|BG000|Baseline|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
11071260|NCT01421472|BG001|Baseline|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
11071261|NCT01421472|BG002|Baseline|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
11071262|NCT01421472|BG003|Baseline|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
11071263|NCT01421472|BG004|Baseline|Total|Total of all reporting groups
11071264|NCT01421472|FG000|Participant Flow|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
11071265|NCT01421472|FG001|Participant Flow|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
11071266|NCT01421472|FG002|Participant Flow|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
11071267|NCT01421472|FG003|Participant Flow|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
11071268|NCT01421472|OG000|Outcome|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
11071269|NCT01421472|OG001|Outcome|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
11071270|NCT01421472|OG002|Outcome|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
11071271|NCT01421472|OG003|Outcome|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
11071272|NCT01421472|EG000|Reported Event|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
11071273|NCT01421472|EG001|Reported Event|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
11071274|NCT01421472|EG002|Reported Event|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
11071275|NCT01421472|EG003|Reported Event|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
11071276|NCT01421498|BG000|Baseline|Lifitegrast 5.0%|
11071277|NCT01421498|BG001|Baseline|Placebo|
11071278|NCT01421498|BG002|Baseline|Total|Total of all reporting groups
11071279|NCT01421498|FG000|Participant Flow|Lifitegrast 5.0%|
11071280|NCT01421498|FG001|Participant Flow|Placebo|
11071281|NCT01421498|OG000|Outcome|Lifitegrast 5.0%|
11071282|NCT01421498|OG001|Outcome|Placebo|
11071283|NCT01421498|EG000|Reported Event|Lifitegrast 5.0%|
11071284|NCT01421498|EG001|Reported Event|Placebo|
11071285|NCT01421511|BG000|Baseline|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
11071286|NCT01421511|BG001|Baseline|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
11071287|NCT01421511|BG002|Baseline|Total|Total of all reporting groups
11071288|NCT01421511|FG000|Participant Flow|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
11071289|NCT01421511|FG001|Participant Flow|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
11071290|NCT01421511|OG000|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
11071291|NCT01421511|OG001|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
11227305|NCT02382016|OG000|Outcome|Macitentan 10 mg|Participants received Macitentan 10 milligram (mg) film-coated tablets orally once daily for 12 weeks in Double-blind treatment period.
11227306|NCT02382016|OG001|Outcome|Placebo|Participants received Macitentan matching placebo film-coated tablets orally once daily for 12 weeks in Double-blind treatment period.
11227307|NCT02382016|EG000|Reported Event|Double-Blind (DB) Period: Macitentan 10 mg|Participants received Macitentan 10 milligram (mg) film-coated tablets orally once daily for 12 weeks during DB treatment period.
11227308|NCT02382016|EG001|Reported Event|DB Period: Placebo|Participants received Macitentan matching placebo film-coated tablets orally once daily for 12 weeks during DB treatment period.
11227309|NCT02382016|EG002|Reported Event|Open-Label (OL) Period: Macitentan 10 mg|Participants received Macitentan 10 milligram (mg) film-coated tablets orally once daily for 12 weeks in Double-blind treatment period. Participants who completed DB treatment period continued to receive macitentan 10 mg for 12 weeks (up to Week 24) in OL treatment period.
11227310|NCT02382016|EG003|Reported Event|OL Extension Period: Macitentan 10 mg|Participants received Macitentan 10 milligram (mg) film-coated tablets orally once daily for 12 weeks in Double-blind treatment period. Participants who completed DB treatment period continued to receive macitentan 10 mg for 12 weeks (up to Week 24) in OL treatment period . Participants (who were randomized at French sites) who completed the core phase of the study as scheduled and opted to continue receiving OL study treatment continued to receive macitentan 10 mg in OLE period.
11227311|NCT02382133|BG000|Baseline|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
11227312|NCT02382133|FG000|Participant Flow|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
11227313|NCT02382133|OG000|Outcome|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
11227314|NCT02382133|EG000|Reported Event|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
11227315|NCT02382276|BG000|Baseline|Nalmefene 20 mg in the lead-in Study|Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11071292|NCT01421511|OG000|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
11227316|NCT02382276|BG001|Baseline|Nalmefene 10 mg in the lead-in Study|Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11227317|NCT02382276|BG002|Baseline|Placebo in the lead-in Study|Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11227318|NCT02382276|BG003|Baseline|Total|Total of all reporting groups
11227319|NCT02382276|FG000|Participant Flow|Nalmefene 20 mg in the lead-in Study|Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11227320|NCT02382276|FG001|Participant Flow|Nalmefene 10 mg in the lead-in Study|Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11227321|NCT02382276|FG002|Participant Flow|Placebo in the lead-in Study|Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11227322|NCT02382276|OG000|Outcome|Nalmefene 20 mg in the lead-in Study|Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11071293|NCT01421511|EG000|Reported Event|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
11071294|NCT01421511|EG001|Reported Event|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
11071295|NCT01421589|BG000|Baseline|Growth Hormone|Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
11071296|NCT01421589|FG000|Participant Flow|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
11227323|NCT02382276|OG001|Outcome|Nalmefene 10 mg in the lead-in Study|Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11227324|NCT02382276|OG002|Outcome|Placebo in the lead-in Study|Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
11227325|NCT02382276|EG000|Reported Event|Total|Nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period in the extension study
11233713|NCT02430870|BG003|Baseline|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11233714|NCT02430870|BG004|Baseline|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11349060|NCT04126343|BG004|Baseline|Treatment Sequence: CAB|Participants received MXF, PSL, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11071297|NCT01421589|OG000|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
11071298|NCT01421589|OG000|Outcome|Growth Hormone|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
11071299|NCT01421589|EG000|Reported Event|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
11071300|NCT01421641|BG000|Baseline|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
11071301|NCT01421641|BG001|Baseline|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
11071302|NCT01421641|BG002|Baseline|Total|Total of all reporting groups
11071303|NCT01421641|FG000|Participant Flow|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
11071304|NCT01421641|FG001|Participant Flow|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
11071305|NCT01421641|OG000|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
11071306|NCT01421641|OG001|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
11071307|NCT01421641|EG000|Reported Event|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
11071308|NCT01421641|EG001|Reported Event|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
11071309|NCT01421654|BG000|Baseline|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
11071310|NCT01421654|BG001|Baseline|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
11071311|NCT01421654|BG002|Baseline|Total|Total of all reporting groups
11071312|NCT01421654|FG000|Participant Flow|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
11071313|NCT01421654|FG001|Participant Flow|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
11071314|NCT01421654|OG000|Outcome|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
11071315|NCT01421654|OG001|Outcome|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
11071316|NCT01421654|EG000|Reported Event|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
11071317|NCT01421654|EG001|Reported Event|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
11071318|NCT01421667|BG000|Baseline|CD30+ T-Cell NHL, BV|
11071319|NCT01421667|BG001|Baseline|CD30+ B-Cell NHL, BV|
11071320|NCT01421667|BG002|Baseline|CD30u DLBCL, BV|
11071321|NCT01421667|BG003|Baseline|CD30+ DLBCL, BV+R|
11071322|NCT01421667|BG004|Baseline|Total|Total of all reporting groups
11071323|NCT01421667|FG000|Participant Flow|CD30+ T-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL)
11071324|NCT01421667|FG001|Participant Flow|CD30+ B-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
11071325|NCT01421667|FG002|Participant Flow|CD30u DLBCL, BV|Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
11071326|NCT01421667|FG003|Participant Flow|CD30+ DLBCL, BV+R|Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)
11071327|NCT01421667|OG000|Outcome|CD30+ T-Cell NHL, BV|Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
11071328|NCT01421667|OG001|Outcome|CD30+ Other B-Cell NHL, BV|Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
11071329|NCT01421667|OG002|Outcome|CD30+ DLBCL, BV|Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
11071330|NCT01421667|OG003|Outcome|CD30u DLBCL, BV|Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
11071331|NCT01421667|OG000|Outcome|CD30+ DLBCL, BV+R|Part B - CD30-positive diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
11071332|NCT01421667|OG000|Outcome|CD30+ DLBCL, BV+R|
11071333|NCT01421667|OG000|Outcome|CD30+ T-Cell NHL, BV|
11071334|NCT01421667|OG001|Outcome|CD30+ Other B-Cell NHL, BV|
11071335|NCT01421667|OG002|Outcome|CD30+ DLBCL, BV|
11071336|NCT01421667|OG003|Outcome|CD30u DLBCL, BV|
11071337|NCT01421667|OG004|Outcome|CD30+ DLBCL, BV+R|
11071338|NCT01421667|OG001|Outcome|CD30+ B-Cell NHL, BV|
11071339|NCT01421667|OG002|Outcome|CD30u DLBCL, BV|
11071340|NCT01421667|EG000|Reported Event|CD30+ NHL (T-Cell and B-Cell), BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL)
11071341|NCT01421667|EG001|Reported Event|CD30u DLBCL, BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
11071342|NCT01421667|EG002|Reported Event|CD30+ DLBCL, BV+R|Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL)
11071343|NCT01421719|BG000|Baseline|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
11071344|NCT01421719|FG000|Participant Flow|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
11071345|NCT01421719|OG000|Outcome|Urinary Leaks Per Day|3-day voiding diary produced the clinical observation as an average per evaluation milestone.
11071346|NCT01421719|OG000|Outcome|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
11071347|NCT01421719|EG000|Reported Event|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
11071348|NCT01422070|BG000|Baseline|Units With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
11071349|NCT01422070|BG001|Baseline|Units Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
11071350|NCT01422070|BG002|Baseline|Total|Total of all reporting groups
11071351|NCT01422070|FG000|Participant Flow|Units in Hospitals With Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals with intermediate care unit
11071352|NCT01422070|FG001|Participant Flow|Units in Hospitals Without Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals without intermediate care unit
11071353|NCT01422070|OG000|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
11071354|NCT01422070|OG001|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
11071355|NCT01422070|EG000|Reported Event|Adverse Events Not Collected|Adverse events were not collected
11071356|NCT01422135|BG000|Baseline|AG200-15|"Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.~AG200-15: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week."
11071357|NCT01422135|FG000|Participant Flow|Lower Abdomen, Buttock, Upper Torso Excluding Breast|Subjects applied AG200-15 to Abdomen, Buttock, then Upper Torso excluding Breast
11071358|NCT01422135|FG001|Participant Flow|Lower Abdomen, Upper Torso Excluding Breast, Buttock|Subjects applied AG200-15 to Abdomen, Upper Torso excluding Breast, then Buttock
11071359|NCT01422135|FG002|Participant Flow|Buttock, Lower Abdomen, Upper Torso Excluding Breast|Subjects applied AG200-15 to Buttock, Abdomen, then Upper Torso excluding Breast
11071360|NCT01422135|FG003|Participant Flow|Buttock, Upper Torso Excluding Breast, Lower Abdomen|Subjects applied AG200-15 to Buttock, Upper Torso excluding Breast, then Lower Abdomen.
11071361|NCT01422135|FG004|Participant Flow|Upper Torso Excluding Breast, Lower Abdomen, Buttock|Subjects applied AG200-15 to Upper Torso excluding Breast, Lower Abdomen, then Buttock
11071362|NCT01422135|FG005|Participant Flow|Upper Torso Excluding Breast, Buttock, Lower Abdomen|Subjects applied AG200-15 to Upper Torso excluding Breast, Buttock, then Lower Abdomen
11071363|NCT01422135|OG000|Outcome|AG200-15|"Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.~AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week."
11071364|NCT01422135|EG000|Reported Event|AG200-15 on Lower Abdomen|"Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.~AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week."
11071365|NCT01422135|EG001|Reported Event|AG200-15 on Buttock|"Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.~AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week."
11071366|NCT01422135|EG002|Reported Event|AG200-15 on Upper Torso Excluding Breast|"Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.~AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week."
11071367|NCT01422161|BG000|Baseline|Botulinum Toxin Commonly Known as BOTOX®|"Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.~Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.~The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study."
11071368|NCT01422161|BG001|Baseline|Placebo|"Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.~Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.~The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study."
11071369|NCT01422161|BG002|Baseline|Total|Total of all reporting groups
11071370|NCT01422161|FG000|Participant Flow|Botulinum Toxin Commonly Known as BOTOX®|"Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.~Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand."
11071371|NCT01422161|FG001|Participant Flow|Placebo|"Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.~The control group will receive a placebo injection."
11071372|NCT01422161|OG000|Outcome|Control (Saline) Group -PRE Treatment|"Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.~Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.~The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study."
11071373|NCT01422161|OG001|Outcome|Botox Group -PRE Treatment|"A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.~There will be 1 treatment cycle during the 9 week study."
11071374|NCT01422161|OG000|Outcome|Control (Saline) Group -POST Treatment|"Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.~Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.~The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study."
11071375|NCT01422161|OG001|Outcome|Botox Group -POST Treatment|A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.There will be 1 treatment cycle during the 9 week study.
11071376|NCT01422161|OG001|Outcome|Botox Group -PRE Treatment|
11071377|NCT01422161|OG000|Outcome|Control (Saline) Group -POST|
11071378|NCT01422161|OG001|Outcome|Botox Group -POST|
11071379|NCT01422161|OG001|Outcome|Botox Group -POST Treatment|
11071380|NCT01422161|OG000|Outcome|Control (Saline) Group -Pre|
11071381|NCT01422161|OG001|Outcome|Botox Group -Pre|
11071382|NCT01422161|EG000|Reported Event|Botulinum Toxin Commonly Known as BOTOX®|"Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.~Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.~The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study."
11071383|NCT01422161|EG001|Reported Event|Placebo|"Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.~Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.~The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study."
11071384|NCT01422187|BG000|Baseline|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071385|NCT01422187|BG001|Baseline|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071386|NCT01422187|BG002|Baseline|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071387|NCT01422187|BG003|Baseline|Total|Total of all reporting groups
11071388|NCT01422187|FG000|Participant Flow|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071389|NCT01422187|FG001|Participant Flow|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071390|NCT01422187|FG002|Participant Flow|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071391|NCT01422187|OG000|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071392|NCT01422187|OG001|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071393|NCT01422187|OG002|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071394|NCT01422187|EG000|Reported Event|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071395|NCT01422187|EG001|Reported Event|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071396|NCT01422187|EG002|Reported Event|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
11071397|NCT01422200|BG000|Baseline|Subcutaneous|2011-2012 Northern Hemisphere formulation inactivated influenza vaccine
11071398|NCT01422200|BG001|Baseline|Intramuscular|2011-2012 Northern Hemisphere formulation inactivated influenza vaccine
11071399|NCT01422200|BG002|Baseline|Total|Total of all reporting groups
11071400|NCT01422200|FG000|Participant Flow|Subcutaneous|2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine
11071401|NCT01422200|FG001|Participant Flow|Intramuscular|2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine
11233715|NCT02430870|BG005|Baseline|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11071402|NCT01422200|OG000|Outcome|Subcutaneous|Subjects receiving 2011-2012 Northern Hemisphere trivalent inactivated influenza vaccine by subcutaneous route
11071403|NCT01422200|OG001|Outcome|Intramuscular|Subjects receiving 2011-2012 Northern Hemisphere trivalent inactivated influenza vaccine
11071404|NCT01422200|OG000|Outcome|Subcutaneous|"0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via subcutaneous route once~2011-2012 seasonal flu vaccine: Subcutaneous flu vaccine"
11071405|NCT01422200|OG001|Outcome|Intramuscular|"0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via intramuscular route once~2011-2012 seasonal flu vaccine: Intramuscular flu vaccine"
11071406|NCT01422200|EG000|Reported Event|Intramuscular|2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine administered once intramuscularly
11071407|NCT01422200|EG001|Reported Event|Subcutaneous|2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine administered once via subcutaneous route
11071408|NCT01422213|BG000|Baseline|Placebo|capsules, daily, orally
11227326|NCT02382640|BG000|Baseline|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
11071409|NCT01422213|BG001|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
11071410|NCT01422213|BG002|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
11071411|NCT01422213|BG003|Baseline|Total|Total of all reporting groups
11071412|NCT01422213|FG000|Participant Flow|Placebo|capsules; daily; orally
11071413|NCT01422213|FG001|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; daily; orally
11071414|NCT01422213|FG002|Participant Flow|Vortioxetine 20 mg|encapsulated tablets; daily; orally
11071415|NCT01422213|OG000|Outcome|Placebo|capsules, daily, orally
11071416|NCT01422213|OG001|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
11071417|NCT01422213|OG002|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
11071418|NCT01422213|EG000|Reported Event|Placebo|
11071419|NCT01422213|EG001|Reported Event|Vortioxetine 10 mg|
11071420|NCT01422213|EG002|Reported Event|Vortioxetine 20 mg|
11071421|NCT01422226|BG000|Baseline|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
11071422|NCT01422226|BG001|Baseline|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
11071423|NCT01422226|BG002|Baseline|Total|Total of all reporting groups
11071424|NCT01422226|FG000|Participant Flow|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
11071425|NCT01422226|FG001|Participant Flow|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
11071426|NCT01422226|OG000|Outcome|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
11071427|NCT01422226|OG001|Outcome|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
11071428|NCT01422226|EG000|Reported Event|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
11071429|NCT01422226|EG001|Reported Event|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
11071430|NCT01422239|BG000|Baseline|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
11071431|NCT01422239|BG001|Baseline|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
11071432|NCT01422239|BG002|Baseline|Total|Total of all reporting groups
11071433|NCT01422239|FG000|Participant Flow|Tailored Behavioral Counseling|The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session, coping with withdrawal symptoms in the third session, and on coping with triggers and withdrawal in the forth session using the Mayo Clinic's smoking cessation manual. The focus of sessions 5-7 will be the three perceive risks of quitting that were not covered during the first three session (i.e., the three least highly endorsed risks). Session 8 will cover maintenance of smoking abstinence using the Mayo Clinic manual.
11071434|NCT01422239|FG001|Participant Flow|Standard Behavioral Counseling|The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's smoking cessation manual. All of the material for sessions 4-8 for the standard behavioral counseling condition will cover topics from the Mayo Clinic's smoking cessation manual - Session 4: coping with triggers to smoke and nicotine withdrawal, Session 5: Stress Management, Session 6: Time Management and Self-Image, Session 7: Communication Skills and Wellness, Session 8: Focusing on the Future (maintenance of smoking abstinence).
11071435|NCT01422239|OG000|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
11091837|NCT01536405|OG000|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
11091838|NCT01536405|OG001|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
11071436|NCT01422239|OG001|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
11071437|NCT01422239|EG000|Reported Event|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
11071438|NCT01422239|EG001|Reported Event|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
11071439|NCT01422304|BG000|Baseline|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
11071440|NCT01422304|BG001|Baseline|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
11071441|NCT01422304|BG002|Baseline|Total|Total of all reporting groups
11071442|NCT01422304|FG000|Participant Flow|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
11071443|NCT01422304|FG001|Participant Flow|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
11071444|NCT01422304|OG000|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
11071445|NCT01422304|OG001|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
11071446|NCT01422304|EG000|Reported Event|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
11071447|NCT01422304|EG001|Reported Event|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
11071448|NCT01422356|BG000|Baseline|12 Month Cohort|
11071449|NCT01422356|FG000|Participant Flow|12 Month Cohort|16-20 year old males
11071450|NCT01422356|OG000|Outcome|Baseline Prevalence|
11071451|NCT01422356|EG000|Reported Event|12 Month Cohort|
11071452|NCT01422369|BG000|Baseline|All Subjects|All randomized subjects
11071453|NCT01422369|FG000|Participant Flow|All Subjects|All randomized subjects
11071454|NCT01422369|OG000|Outcome|NK-104|NK-104 4mg once daily (QD)
11071455|NCT01422369|OG000|Outcome|All Subjects|All randomized subjects
11071456|NCT01422369|EG000|Reported Event|All Subjects|All randomized subjects
11349061|NCT04126343|BG005|Baseline|Treatment Sequence: CBA|Participants received MXF, Placebo, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11071457|NCT01422382|BG000|Baseline|All Subjects|All randomized subjects.
11349062|NCT04126343|BG006|Baseline|Total Title|
11071458|NCT01422382|FG000|Participant Flow|All Subjects|All randomized subjects.
11071459|NCT01422382|OG000|Outcome|All Subjects|All randomized subjects.
11071460|NCT01422382|EG000|Reported Event|All Subjects|All randomized subjects.
11071461|NCT01422408|BG000|Baseline|Supportive Care|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
11071462|NCT01422408|FG000|Participant Flow|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
11071463|NCT01422408|OG000|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
11071464|NCT01422408|EG000|Reported Event|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
11071465|NCT01422434|BG000|Baseline|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
11071466|NCT01422434|BG001|Baseline|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
11071467|NCT01422434|BG002|Baseline|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
11071468|NCT01422434|BG003|Baseline|Total|Total of all reporting groups
11071469|NCT01422434|FG000|Participant Flow|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
11071470|NCT01422434|FG001|Participant Flow|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
11071471|NCT01422434|FG002|Participant Flow|Rinderon® - DP Ointment (Betamethasone Dipropionate)|"Applied once daily for 4 weeks~Rinderon® - DP ointment ( betamethasone dipropionate) : Applied once daily for 4 weeks."
11071472|NCT01422434|OG000|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
11071473|NCT01422434|OG001|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
11071474|NCT01422434|OG002|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
11071475|NCT01422434|EG000|Reported Event|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
11071476|NCT01422434|EG001|Reported Event|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
11071477|NCT01422434|EG002|Reported Event|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
11071478|NCT01422538|BG000|Baseline|Group A|Subjects received Ultherapy® Treatment only. Study subjects in Group A received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
11071479|NCT01422538|BG001|Baseline|Group B|Subjects received Sculptra® treatment only
11071480|NCT01422538|BG002|Baseline|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment. Study subjects in Group C received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
11071481|NCT01422538|BG003|Baseline|Total|Total of all reporting groups
11071482|NCT01422538|FG000|Participant Flow|Group A|Subjects received Ultherapy® Treatment only.
11071483|NCT01422538|FG001|Participant Flow|Group B|Subjects received Sculptra® treatment only
11071484|NCT01422538|FG002|Participant Flow|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
11071485|NCT01422538|OG000|Outcome|Group A|Subjects received Ultherapy® Treatment only.
11071486|NCT01422538|OG001|Outcome|Group B|Subjects received Sculptra® treatment only
11071487|NCT01422538|OG002|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
11071488|NCT01422538|OG001|Outcome|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
11071489|NCT01422538|EG000|Reported Event|Group A|Subjects received Ultherapy® Treatment only.
11071490|NCT01422538|EG001|Reported Event|Group B|Subjects received Sculptra® only.
11071491|NCT01422538|EG002|Reported Event|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
11071492|NCT01422720|BG000|Baseline|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
11071493|NCT01422720|FG000|Participant Flow|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
11071494|NCT01422720|OG000|Outcome|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
11071495|NCT01422720|OG000|Outcome|FAS - Baseline Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
11071496|NCT01422720|OG001|Outcome|FAS - Treatment Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
11071497|NCT01422720|OG002|Outcome|PPS - Baseline Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
11071498|NCT01422720|OG003|Outcome|PPS- Treatment Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
11071499|NCT01422720|EG000|Reported Event|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
11071500|NCT01422824|BG000|Baseline|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
11071501|NCT01422824|FG000|Participant Flow|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
11071502|NCT01422824|OG000|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
11071503|NCT01422824|EG000|Reported Event|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
11071504|NCT01422850|BG000|Baseline|ALECSAT|
11071505|NCT01422850|FG000|Participant Flow|ALECSAT|After inclusion in the ALECSAT trial, the subject donates 200 ml blood sample for the first ALECSAT product, and after 6 and 11 weeks the subject donated 200 ml again for the second and third product. ALECSAT was thereafter administered at week 4, 9, and week 14.
11071506|NCT01422850|OG000|Outcome|ALCESAT|
11071507|NCT01422850|OG000|Outcome|Trends Towards Possible Treatment Response|No significant conclusion of efficacy is possible due to the study design with only one active group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy are possible. Scintigraphy and blood tests (PSA, ALP, LDH and Creatinine)were used for this analysis.
11071508|NCT01422850|OG000|Outcome|ALECSAT|
11071509|NCT01422850|EG000|Reported Event|ALECSAT|
11071510|NCT01422876|BG000|Baseline|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
11071511|NCT01422876|BG001|Baseline|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
11071512|NCT01422876|BG002|Baseline|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
11071513|NCT01422876|BG003|Baseline|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
11071514|NCT01422876|BG004|Baseline|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
11071515|NCT01422876|BG005|Baseline|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
11071516|NCT01422876|BG006|Baseline|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
11071517|NCT01422876|BG007|Baseline|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
11071518|NCT01422876|BG008|Baseline|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
11071519|NCT01422876|BG009|Baseline|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
11071520|NCT01422876|BG010|Baseline|Total|Total of all reporting groups
11071521|NCT01422876|FG000|Participant Flow|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin: Oral
11071522|NCT01422876|FG001|Participant Flow|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
11071523|NCT01422876|FG002|Participant Flow|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
11071524|NCT01422876|FG003|Participant Flow|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
11071525|NCT01422876|FG004|Participant Flow|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
11071526|NCT01422876|FG005|Participant Flow|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
11071527|NCT01422876|FG006|Participant Flow|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
11071528|NCT01422876|FG007|Participant Flow|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
11071529|NCT01422876|FG008|Participant Flow|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
11071530|NCT01422876|FG009|Participant Flow|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
11071531|NCT01422876|OG000|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
11071532|NCT01422876|OG001|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
11071533|NCT01422876|OG002|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
11071534|NCT01422876|OG003|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
11071535|NCT01422876|OG004|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
11071536|NCT01422876|OG003|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Ora"
11071537|NCT01422876|OG000|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
11071538|NCT01422876|OG001|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
11071539|NCT01422876|OG002|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
11071540|NCT01422876|OG003|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
11071541|NCT01422876|OG004|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
11071542|NCT01422876|EG000|Reported Event|Empagliflozin 25 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral
11071543|NCT01422876|EG001|Reported Event|Empagliflozin 10 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
11071544|NCT01422876|EG002|Reported Event|Empagliflozin 25 mg|Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
11071545|NCT01422876|EG003|Reported Event|Empagliflozin 10 mg|Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
11071546|NCT01422876|EG004|Reported Event|Linagliptin 5 mg|Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
11071547|NCT01422889|BG000|Baseline|ION Registry|The ION Registry population contains 1120 enrolled subjects with 1111 eligible for analysis. Subjects eligible for analysis includes subjects with at least one study stent implanted.
11071548|NCT01422889|FG000|Participant Flow|ION Registry|The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.
11071549|NCT01422889|OG000|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
11071550|NCT01422889|EG000|Reported Event|ION Registry|The ION Registry population will contain the first 1115 consecutive, consenting patients
11071551|NCT01422915|BG000|Baseline|Colestipol Therapy of Protoporphyria|4 subjects were assigned, all between 18-65 years of age.
11071552|NCT01422915|FG000|Participant Flow|Colestipol Treatment|Colestipol 2 grams twice daily for 5-6 months. Completion of sun sensitivity questionnaire and blood protoporphyrin concentrations. were obtained monthly.
11071553|NCT01422915|OG000|Outcome|Colestipol Treatment|"gram morning and bedtime for 90 days; then~grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concns. were determined monthly."
11071554|NCT01422915|OG000|Outcome|Colestipol Treatment|Sun sensitivity and protoporphyrin levels
11071555|NCT01422915|EG000|Reported Event|1st Period - Colestipol Optimal Dosage|"gram morning and bedtime for 90 days; then~grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concentrations were determined monthly."
11071556|NCT01423084|BG000|Baseline|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
11071557|NCT01423084|BG001|Baseline|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
11071558|NCT01423084|BG002|Baseline|Total|Total of all reporting groups
11071559|NCT01423084|FG000|Participant Flow|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
11071560|NCT01423084|FG001|Participant Flow|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
11071561|NCT01423084|OG000|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
11071562|NCT01423084|OG001|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
11071563|NCT01423084|OG001|Outcome|MenB Lot 2|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
11071564|NCT01423084|EG000|Reported Event|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
11071565|NCT01423084|EG001|Reported Event|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
11071566|NCT01423162|BG000|Baseline|Drink With Vit C Then Drink Without Vit C|Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C
11071567|NCT01423162|BG001|Baseline|Drink Without Vit C Then Drink With Vit C|Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
11071568|NCT01423162|BG002|Baseline|Total|Total of all reporting groups
11071569|NCT01423162|FG000|Participant Flow|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
11071570|NCT01423162|FG001|Participant Flow|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
11071571|NCT01423162|OG000|Outcome|Fortified Oat Drink With Vitamin C|
11071572|NCT01423162|OG001|Outcome|Fortified Oat Drink Without Vitamin C|
11071573|NCT01423162|EG000|Reported Event|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
11071574|NCT01423162|EG001|Reported Event|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
11071575|NCT01423253|BG000|Baseline|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
11071576|NCT01423253|FG000|Participant Flow|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
11071577|NCT01423253|OG000|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
11071578|NCT01423253|EG000|Reported Event|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
11071579|NCT01423604|BG000|Baseline|Ruxolitinib - Safety Run-In|Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]) + ruxolitinib at 15 mg BID.
11071580|NCT01423604|BG001|Baseline|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
11071581|NCT01423604|BG002|Baseline|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
11071582|NCT01423604|BG003|Baseline|Total|Total of all reporting groups
11071583|NCT01423604|FG000|Participant Flow|Ruxolitinib|"Part 1: Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) + ruxolitinib 15 mg BID.~Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID])."
11071584|NCT01423604|FG001|Participant Flow|Placebo|Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
11071585|NCT01423604|OG000|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
11071586|NCT01423604|OG001|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
11071587|NCT01423604|EG000|Reported Event|Ruxolitinib (Safety Run-In)|Subjects received capecitabine 2000 mg/m^2 daily (taken as 1000 mg/m2 twice daily [BID]) + ruxolitinib 15 mg BID
11071588|NCT01423604|EG001|Reported Event|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
11071589|NCT01423604|EG002|Reported Event|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
11071590|NCT01423617|BG000|Baseline|Zenoctil|Zenoctil: 3 tablets 2 times daily
11071591|NCT01423617|BG001|Baseline|Placebo|Placebo: 3 tablets 2 times daily
11071592|NCT01423617|BG002|Baseline|Total|Total of all reporting groups
11071593|NCT01423617|FG000|Participant Flow|Zenoctil|Zenoctil: 3 tablets 2 times daily
11071594|NCT01423617|FG001|Participant Flow|Placebo|Placebo: 3 tablets 2 times daily
11071595|NCT01423617|OG000|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
11071596|NCT01423617|OG001|Outcome|Placebo|Placebo: 3 tablets 2 times daily
11071597|NCT01423617|EG000|Reported Event|Zenoctil|Zenoctil: 3 tablets 2 times daily
11071598|NCT01423617|EG001|Reported Event|Placebo|Placebo: 3 tablets 2 times daily
11227327|NCT02382640|BG001|Baseline|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
11233716|NCT02430870|BG006|Baseline|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11233717|NCT02430870|BG007|Baseline|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11233718|NCT02430870|BG008|Baseline|Total|Total of all reporting groups
11233719|NCT02430870|FG000|Participant Flow|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11071599|NCT01423760|BG000|Baseline|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
11071600|NCT01423760|BG001|Baseline|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.~Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
11071601|NCT01423760|BG002|Baseline|Total|Total of all reporting groups
11091839|NCT01536405|EG000|Reported Event|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
11091840|NCT01536405|EG001|Reported Event|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
11071602|NCT01423760|FG000|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
11071603|NCT01423760|FG001|Participant Flow|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.~Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
11071604|NCT01423760|OG000|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
11071605|NCT01423760|OG001|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
11071606|NCT01423760|EG000|Reported Event|NSCLC|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
11071607|NCT01423760|EG001|Reported Event|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
11071608|NCT01423773|BG000|Baseline|Overall|Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
11071609|NCT01423773|FG000|Participant Flow|Lotrafilcon A Test, Then Lotrafilcon A Control|Lotrafilcon A test contact lenses worn in Period One, with lotrafilcon A control contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
11071610|NCT01423773|FG001|Participant Flow|Lotrafilcon A Control, Then Lotrafilcon A Test|Lotrafilcon A control contact lenses worn in Period One, with lotrafilcon A test contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
11071611|NCT01423773|OG000|Outcome|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
11071612|NCT01423773|OG001|Outcome|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
11071613|NCT01423773|EG000|Reported Event|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
11071614|NCT01423773|EG001|Reported Event|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
11071615|NCT01423812|BG000|Baseline|Once-daily Darunavir/Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
11071616|NCT01423812|BG001|Baseline|Twice-daily Darunavir/Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
11071617|NCT01423812|BG002|Baseline|Total|Total of all reporting groups
11071618|NCT01423812|FG000|Participant Flow|Once-daily Darunavir/Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
11071619|NCT01423812|FG001|Participant Flow|Twice-daily Darunavir/Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
11071620|NCT01423812|OG000|Outcome|Once-daily Darunavir/Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
11071621|NCT01423812|OG001|Outcome|Twice-daily Darunavir/Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
11071622|NCT01423812|OG000|Outcome|Once-daily Darunavir and Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir and ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
11071623|NCT01423812|OG001|Outcome|Twice-daily Darunavir and Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir and ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
11071624|NCT01423812|EG000|Reported Event|Once-daily Darunavir/Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
11071625|NCT01423812|EG001|Reported Event|Twice-daily Darunavir/Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
11071626|NCT01423916|BG000|Baseline|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071627|NCT01423916|BG001|Baseline|Brexpiprzole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071628|NCT01423916|BG002|Baseline|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
11071629|NCT01423916|BG003|Baseline|Total|Total of all reporting groups
11071630|NCT01423916|FG000|Participant Flow|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD (once daily) on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071631|NCT01423916|FG001|Participant Flow|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071632|NCT01423916|FG002|Participant Flow|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
11071633|NCT01423916|OG000|Outcome|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
11071634|NCT01423916|OG001|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071635|NCT01423916|OG002|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071636|NCT01423916|OG000|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071637|NCT01423916|OG002|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
11071638|NCT01423916|OG003|Outcome|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
11071639|NCT01423916|OG002|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
11071640|NCT01423916|OG002|Outcome|Moxifloxacin 400 mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
11071641|NCT01423916|OG003|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
11071642|NCT01423916|OG002|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
11071643|NCT01423916|OG002|Outcome|Moxifloaxcin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
11071644|NCT01423916|OG000|Outcome|Brexpiprazole 4mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071645|NCT01423916|OG001|Outcome|Brexpiprazole 12mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071646|NCT01423916|EG000|Reported Event|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071647|NCT01423916|EG001|Reported Event|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
11071648|NCT01423916|EG002|Reported Event|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
11071649|NCT01423916|EG003|Reported Event|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
11071650|NCT01424033|BG000|Baseline|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
11071651|NCT01424033|FG000|Participant Flow|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
11071652|NCT01424033|OG000|Outcome|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
11071653|NCT01424033|EG000|Reported Event|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
11071654|NCT01424072|BG000|Baseline|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
11071655|NCT01424072|BG001|Baseline|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
11071656|NCT01424072|BG002|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
11071657|NCT01424072|BG003|Baseline|Total|Total of all reporting groups
11071658|NCT01424072|FG000|Participant Flow|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
11071659|NCT01424072|FG001|Participant Flow|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
11071660|NCT01424072|FG002|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
11071661|NCT01424072|OG000|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
11071662|NCT01424072|OG001|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
11071663|NCT01424072|OG002|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
11071664|NCT01424072|EG000|Reported Event|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
11071665|NCT01424072|EG001|Reported Event|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
11071666|NCT01424072|EG002|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
11071667|NCT01424189|BG000|Baseline|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11071668|NCT01424189|BG001|Baseline|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
11071669|NCT01424189|BG002|Baseline|Total|Total of all reporting groups
11071670|NCT01424189|FG000|Participant Flow|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
11071671|NCT01424189|FG001|Participant Flow|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
11071672|NCT01424189|OG000|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11071673|NCT01424189|OG001|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
11071674|NCT01424189|EG000|Reported Event|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
11071675|NCT01424189|EG001|Reported Event|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
11071676|NCT01424215|BG000|Baseline|ICG Injection With Spyscope Imaging|"Indocyanine Green (ICG)~Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)"
11071677|NCT01424215|BG001|Baseline|Standard Critical View Technique|50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.
11071678|NCT01424215|BG002|Baseline|Total|Total of all reporting groups
11071679|NCT01424215|FG000|Participant Flow|ICG Injection With Spyscope Imaging|"Indocyanine Green (ICG)~Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)"
11071680|NCT01424215|FG001|Participant Flow|Standard Critical View Technique|50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.
11071681|NCT01424215|OG000|Outcome|ICG Injection With Spyscope Imaging|"Indocyanine Green (ICG)~Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)"
11071682|NCT01424215|OG001|Outcome|Standard Critical View Technique|50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.
11071683|NCT01424215|EG000|Reported Event|ICG Injection With Spyscope Imaging|"Indocyanine Green (ICG)~Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)"
11071684|NCT01424215|EG001|Reported Event|Standard Critical View Technique|50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.
11071685|NCT01424228|BG000|Baseline|Placebo|Tablet once daily before breakfast
11071686|NCT01424228|BG001|Baseline|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
11071687|NCT01424228|BG002|Baseline|Total|Total of all reporting groups
11071688|NCT01424228|FG000|Participant Flow|Placebo|Tablet once daily before breakfast
11071689|NCT01424228|FG001|Participant Flow|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
11071690|NCT01424228|OG000|Outcome|Placebo|Tablet once daily before breakfast
11071691|NCT01424228|OG001|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
11071692|NCT01424228|EG000|Reported Event|Placebo|Tablet once daily before breakfast
11071693|NCT01424228|EG001|Reported Event|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
11071694|NCT01424293|BG000|Baseline|Indocyanine Green|"1ml of intravenous ICG and imaging transanally using the Spyscope system~Indocyanine Green: 1ml of intravenous ICG and imaging transanally using the Spyscope system~The SPY® Intraoperative Imaging System"
11071695|NCT01424293|FG000|Participant Flow|Indocyanine Green|"1ml of intravenous ICG and imaging transanally using the Spyscope system~Indocyanine Green: 1ml of intravenous ICG and imaging transanally using the Spyscope system~The SPY® Intraoperative Imaging System"
11071696|NCT01424293|OG000|Outcome|Indocyanine Green|"1ml of intravenous ICG and imaging transanally using the Spyscope system~Indocyanine Green: 1ml of intravenous ICG and imaging transanally using the Spyscope system~The SPY® Intraoperative Imaging System"
11071697|NCT01424293|EG000|Reported Event|Indocyanine Green|"1ml of intravenous ICG and imaging transanally using the Spyscope system~Indocyanine Green: 1ml of intravenous ICG and imaging transanally using the Spyscope system~The SPY® Intraoperative Imaging System"
11071698|NCT01424306|BG000|Baseline|Study Subjects|All six treatment orders combined
11071699|NCT01424306|FG000|Participant Flow|Fructose - Glucose - HFCS|"Subjects treated in the order fructose-sweetened beverage - wash out - glucose-sweetened beverage- wash out - HFCS-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
11071700|NCT01424306|FG001|Participant Flow|Fructose - HFCS - Glucose|"Subjects treated in the order fructose-sweetened beverage - wash out - HFCS-sweetened beverage- wash out - glucose-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
11071701|NCT01424306|FG002|Participant Flow|HFCS - Fructose - Glucose|"Subjects treated in the order HFCS-sweetened beverage - wash out - fructose-sweetened beverage- wash out - glucose-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
11071702|NCT01424306|FG003|Participant Flow|HFCS - Glucose - Fructose|"Subjects treated in the order HFCS-sweetened beverage - wash out - glucose-sweetened beverage- wash out - fructose-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
11071703|NCT01424306|FG004|Participant Flow|Glucose - Fructose - HFCS|"Subjects treated in the order glucose-sweetened beverage - wash out - fructose-sweetened beverage- wash out - HFCS-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
11071704|NCT01424306|FG005|Participant Flow|Glucose - HFCS - Fructose|"Subjects treated in the order glucose-sweetened beverage - wash out - HFCS-sweetened beverage- wash out - fructose-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
11071705|NCT01424306|OG000|Outcome|Fructose Arm - Day 1|CRP measured on day 1 of fructose-sweetened beverage intervention period
11071706|NCT01424306|OG001|Outcome|Fructose Arm - Day 9|CRP measured on day 9 of fructose-sweetened beverage intervention period
11071707|NCT01424306|OG002|Outcome|Glucose Arm - Day 1|CRP measured on day 1 of glucose-sweetened beverage intervention period
11071708|NCT01424306|OG003|Outcome|Glucose Arm - Day 9|CRP measured on day 9 of glucose-sweetened beverage intervention period
11071709|NCT01424306|OG004|Outcome|HFCS Arm - Day 1|CRP measured on day 1 of HFCS-sweetened beverage intervention period
11071710|NCT01424306|OG005|Outcome|HFCS Arm - Day 9|CRP measured on day 9 of HFCS-sweetened beverage intervention period
11071711|NCT01424306|OG000|Outcome|Fructose Arm - Day 9|IL-6 measured on day 9 of fructose-sweetened beverage intervention period
11071712|NCT01424306|OG001|Outcome|Glucose Arm - Day 9|IL-6 measured on day 9 of glucose-sweetened beverage intervention period
11071713|NCT01424306|OG002|Outcome|HFCS Arm - Day 9|IL-6 measured on day 9 of HFCS-sweetened beverage intervention period
11071714|NCT01424306|OG000|Outcome|Fructose Arm - Day 9|Adiponectin measured on day 9 of fructose-sweetened beverage intervention period
11071715|NCT01424306|OG001|Outcome|Glucose Arm - Day 9|Adiponectin measured on day 9 of glucose-sweetened beverage intervention period
11071716|NCT01424306|OG002|Outcome|HFCS Arm - Day 9|Adiponectin measured on day 9 of HFCS-sweetened beverage intervention period
11071717|NCT01424306|OG000|Outcome|Fructose Arm|Average total energy consumed each day during the fructose-sweetened beverage intervention period
11071718|NCT01424306|OG001|Outcome|Glucose Arm|Average total energy consumed each day during the glucose-sweetened beverage intervention period
11071719|NCT01424306|OG002|Outcome|HFCS Arm|Average total energy consumed each day during the HFCS-sweetened beverage intervention period
11071720|NCT01424306|OG000|Outcome|Fructose Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of fructose-sweetened beverage intervention period
11071721|NCT01424306|OG001|Outcome|Glucose Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of glucose-sweetened beverage intervention period
11071722|NCT01424306|OG002|Outcome|HFCS Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of HFCS-sweetened beverage intervention period
11071723|NCT01424306|OG000|Outcome|Fructose Arm - Day 9|Zonulin measured on day 9 of fructose-sweetened beverage intervention period
11071724|NCT01424306|OG001|Outcome|Glucose Arm - Day 9|Zonulin measured on day 9 of glucose-sweetened beverage intervention period
11071725|NCT01424306|OG002|Outcome|HFCS Arm - Day 9|Zonulin measured on day 9 of HFCS-sweetened beverage intervention period
11071726|NCT01424306|OG000|Outcome|Fructose Arm - Day 9|LBP measured on day 9 of fructose-sweetened beverage intervention period
11071727|NCT01424306|OG001|Outcome|Glucose Arm - Day 9|LBP measured on day 9 of glucose-sweetened beverage intervention period
11071728|NCT01424306|OG002|Outcome|HFCS Arm - Day 9|LBP measured on day 9 of HFCS-sweetened beverage intervention period
11071729|NCT01424306|OG000|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
11071730|NCT01424306|OG001|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
11071731|NCT01424306|OG002|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
11071732|NCT01424306|EG000|Reported Event|Fructose Arm|Powdered fructose mixed with powdered drink flavoring (Lemon)
11071733|NCT01424306|EG001|Reported Event|Glucose Arm|Powdered dextrose mixed with powdered drink flavoring (Lemon) and aspartame to match sweetness
11071734|NCT01424306|EG002|Reported Event|HFCS Arm|HFCS liquid mixed with powdered drink flavoring (Lemon) and aspartame to match sweetness
11071735|NCT01424397|BG000|Baseline|Treatment A First, Then B, Then D|Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered once-daily (OD) in morning for 8 days and 4 actuations per nostril of placebo matching Fluticasone propionate (FP) alone were administered OD in evening for 7 days). Participants received FP 200 microgram (μg) alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 milligrams (mg) SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071736|NCT01424397|BG001|Baseline|Treatment B First, Then A, Then D|Eligible participants received Participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071737|NCT01424397|BG002|Baseline|Treatment B, Then D, Then A|Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days).There was a 14-20 days washout between 2 treatment periods.
11071738|NCT01424397|BG003|Baseline|Treatment A, Then D, Then B|Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071739|NCT01424397|BG004|Baseline|Treatment D, Then A, Then B|Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071740|NCT01424397|BG005|Baseline|Treatment D, Then B, Then A|Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071741|NCT01424397|BG006|Baseline|Treatment A, Then B, Then C|Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071742|NCT01424397|BG007|Baseline|Treatment B, Then A, Then C|Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071743|NCT01424397|BG008|Baseline|Treatment B, Then C, Then A|Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071744|NCT01424397|BG009|Baseline|Treatment A, Then C, Then B|Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071745|NCT01424397|BG010|Baseline|Treatment C, Then A, Then B|Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071746|NCT01424397|BG011|Baseline|Treatment C, Then B, Then A|Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071747|NCT01424397|BG012|Baseline|Total|Total of all reporting groups
11071748|NCT01424397|FG000|Participant Flow|Treatment A First, Then B, Then D|Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered once-daily (OD) in morning for 8 days and 4 actuations per nostril of placebo matching Fluticasone propionate (FP) alone were administered OD in evening for 7 days). Participants received FP 200 microgram (μg) alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 milligrams (mg) SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071749|NCT01424397|FG001|Participant Flow|Treatment B First, Then A, Then D|Eligible participants received Participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071750|NCT01424397|FG002|Participant Flow|Treatment B, Then D, Then A|Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days).There was a 14-20 days washout between 2 treatment periods.
11071751|NCT01424397|FG003|Participant Flow|Treatment A, Then D, Then B|Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071752|NCT01424397|FG004|Participant Flow|Treatment D, Then A, Then B|Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071753|NCT01424397|FG005|Participant Flow|Treatment D, Then B, Then A|Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071754|NCT01424397|FG006|Participant Flow|Treatment A, Then B, Then C|Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11091841|NCT01536418|BG000|Baseline|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
11091842|NCT01536418|BG001|Baseline|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
11091843|NCT01536418|BG002|Baseline|Total|Total of all reporting groups
11071755|NCT01424397|FG007|Participant Flow|Treatment B, Then A, Then C|Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071756|NCT01424397|FG008|Participant Flow|Treatment B, Then C, Then A|Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071757|NCT01424397|FG009|Participant Flow|Treatment A, Then C, Then B|Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071758|NCT01424397|FG010|Participant Flow|Treatment C, Then A, Then B|Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071759|NCT01424397|FG011|Participant Flow|Treatment C, Then B, Then A|Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
11071760|NCT01424397|OG000|Outcome|Placebo|Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11071761|NCT01424397|OG001|Outcome|FP 200 μg|Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.
11071762|NCT01424397|OG002|Outcome|SB-705498 12 mg|Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11071763|NCT01424397|OG003|Outcome|SB-705498 + FP 12 mg|Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11071764|NCT01424397|OG000|Outcome|SB-705498 12 mg|Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11071765|NCT01424397|OG001|Outcome|SB-705498 + FP 12 mg|Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11071766|NCT01424397|OG003|Outcome|SB-705498 + FP 12 mg|Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11091844|NCT01536418|FG000|Participant Flow|GSK1605786A, 500 Milligram (mg), Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
11349063|NCT04126343|FG000|Participant Flow|Treatment Sequence: ABC|"Padsevonil (PSL) Treatment Period (Treatment A)- participants received PSL 100 milligrams (mg) to 400 mg, orally twice daily (bid) during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon.~Placebo Treatment Period (Treatment B)-participants received Placebo matched to PSL Treatment Period doses, bid up to Day 11.~Moxifloxacin (MXF) Treatment Period (Treatment C)- participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon.~Participants received PSL, Placebo, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods."
11349064|NCT04126343|FG001|Participant Flow|Treatment Sequence: ACB|Participants received PSL, MXF, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11349065|NCT04126343|FG002|Participant Flow|Treatment Sequence: BAC|Participants received Placebo, PSL, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11349066|NCT04126343|FG003|Participant Flow|Treatment Sequence: BCA|Participants received Placebo, MXF, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11071767|NCT01424397|OG003|Outcome|SB-705498 + FP 12 mg|Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B
11071768|NCT01424397|EG000|Reported Event|Placebo|Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11071769|NCT01424397|EG001|Reported Event|FP 200 μg|Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.
11071770|NCT01424397|EG002|Reported Event|SB-705498 12 mg|Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11071771|NCT01424397|EG003|Reported Event|SB-705498 + FP 12 mg|Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
11071772|NCT01424501|BG000|Baseline|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071773|NCT01424501|BG001|Baseline|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071774|NCT01424501|BG002|Baseline|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071775|NCT01424501|BG003|Baseline|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071776|NCT01424501|BG004|Baseline|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11349067|NCT04126343|FG004|Participant Flow|Treatment Sequence: CAB|Participants received MXF, PSL, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11349068|NCT04126343|FG005|Participant Flow|Treatment Sequence: CBA|Participants received MXF, Placebo, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
11349069|NCT04126343|OG000|Outcome|Padsevonil (QT/QTc Set)|Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
11349070|NCT04126343|OG000|Outcome|Moxifloxacin (QT/QTc Set)|"Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.~On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set."
11349071|NCT04126343|OG001|Outcome|Moxifloxacin (QT/QTc Set)|"Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.~On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set."
11349072|NCT04126343|OG002|Outcome|Placebo (QT/QTc Set)|Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
11349073|NCT04126343|OG000|Outcome|Metabolite 1 (QT/QTc Set)|Participants received PSL (padsevonil metabolite 1) 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/QTc Set.
11071777|NCT01424501|BG005|Baseline|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071778|NCT01424501|BG006|Baseline|Total|Total of all reporting groups
11071779|NCT01424501|FG000|Participant Flow|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071780|NCT01424501|FG001|Participant Flow|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071781|NCT01424501|FG002|Participant Flow|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071782|NCT01424501|FG003|Participant Flow|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071783|NCT01424501|FG004|Participant Flow|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071784|NCT01424501|FG005|Participant Flow|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071785|NCT01424501|OG000|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071786|NCT01424501|OG001|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071787|NCT01424501|OG002|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071788|NCT01424501|OG003|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071789|NCT01424501|OG004|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071790|NCT01424501|OG005|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071791|NCT01424501|OG000|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1
11071792|NCT01424501|EG000|Reported Event|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071793|NCT01424501|EG001|Reported Event|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071794|NCT01424501|EG002|Reported Event|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071795|NCT01424501|EG003|Reported Event|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071796|NCT01424501|EG004|Reported Event|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
11071797|NCT01424501|EG005|Reported Event|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
11071798|NCT01424514|BG000|Baseline|All Treatments Combined|The study consisted of 2 treatment periods, each of 14 days (2 weeks). The treatment periods were separated by at least 4 weeks of washout period. Participants were administered intranasal spray of SB-705498 12 milligram (mg) or matching placebo as repeat doses for 14 days once daily in treatment period 1 (TP1), and the converse treatments in TP2 two treatment sequences (active/placebo [A/P] or placebo/active [P/A]) with respect to the randomization.
11071799|NCT01424514|FG000|Participant Flow|Active Then Placebo|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days during intervention period 1 according to a plan of randomization. After a washout period of 4 weeks, participants then received repeat doses of matching placebo once daily for 14 days during intervention period 2.
11071800|NCT01424514|FG001|Participant Flow|Placebo Then Active|Participants received repeat doses of matching placebo once daily for 14 days during intervention period 1 according to a plan of randomization. After a washout period of 4 weeks, participants then received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days during intervention
11071801|NCT01424514|OG000|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
11071802|NCT01424514|OG001|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
11071803|NCT01424514|OG000|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active)separated by at least 4 weeks of washout period.
11071804|NCT01424514|OG000|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
11071805|NCT01424514|OG001|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
11071806|NCT01424514|OG000|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
11071807|NCT01424514|OG001|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
11071808|NCT01424514|EG000|Reported Event|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
11071809|NCT01424514|EG001|Reported Event|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
11071810|NCT01424566|BG000|Baseline|Single-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 2 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11071811|NCT01424566|FG000|Participant Flow|Single-blind Nabiximols|Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 2 weeks. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligrams [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
11071812|NCT01424566|FG001|Participant Flow|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in Numerical Rating Scale (NRS) pain scores during the single-blind treatment period (Part A).
11071813|NCT01424566|FG002|Participant Flow|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
11071814|NCT01424566|OG000|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
11071815|NCT01424566|OG001|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
11071816|NCT01424566|EG000|Reported Event|Single-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 2 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. Two participants did not receive study drug and are not included in the safety set.
11071817|NCT01424566|EG001|Reported Event|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
11091845|NCT01536418|FG001|Participant Flow|GSK1605786A, 500 mg Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
11071818|NCT01424566|EG002|Reported Event|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
11071819|NCT01424644|BG000|Baseline|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
11071820|NCT01424644|BG001|Baseline|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
11071821|NCT01424644|BG002|Baseline|Total|Total of all reporting groups
11071822|NCT01424644|FG000|Participant Flow|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
11071823|NCT01424644|FG001|Participant Flow|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
11071824|NCT01424644|OG000|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
11071825|NCT01424644|OG001|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
11071826|NCT01424644|EG000|Reported Event|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
11071827|NCT01424644|EG001|Reported Event|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
11071828|NCT01424670|BG000|Baseline|Delamanid + OBR|"In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.~Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months."
11071829|NCT01424670|BG001|Baseline|Placebo + OBR|"In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.~Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months."
11071830|NCT01424670|BG002|Baseline|Total|Total of all reporting groups
11071831|NCT01424670|FG000|Participant Flow|Delamanid + OBR|"In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 milligrams (mg) delamanid orally twice daily (BID) (morning and evening) + OBR for 2 months, followed by 200 mg delamanid once daily (QD) (every morning) + OBR for 4 months.~Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months."
11071832|NCT01424670|FG001|Participant Flow|Placebo + OBR|"In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.~Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months."
11071833|NCT01424670|OG000|Outcome|Delamanid + OBR|In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
11071834|NCT01424670|OG001|Outcome|Placebo + OBR|In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
11071835|NCT01424670|OG000|Outcome|Delamanid + OBR|"In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.~Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months."
11071836|NCT01424670|OG001|Outcome|Placebo + OBR|"In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.~Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months."
11071837|NCT01424670|EG000|Reported Event|Delamanid + OBR|"In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.~Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months."
11071838|NCT01424670|EG001|Reported Event|Placebo + OBR|"In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.~Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months."
11071839|NCT01424722|BG000|Baseline|ST Monitoring Feature|Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
11071840|NCT01424722|FG000|Participant Flow|ST Monitoring Feature|Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
11071841|NCT01424722|OG000|Outcome|ST Monitoring Feature|Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
11071842|NCT01424722|EG000|Reported Event|ST Monitoring Feature|Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
11071843|NCT01424813|BG000|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
11071844|NCT01424813|BG001|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
11071845|NCT01424813|BG002|Baseline|Total|Total of all reporting groups
11071846|NCT01424813|FG000|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
11071847|NCT01424813|FG001|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
11071848|NCT01424813|OG000|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
11071849|NCT01424813|OG001|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
11071850|NCT01424813|EG000|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
11071851|NCT01424813|EG001|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
11071852|NCT01424930|BG000|Baseline|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
11071853|NCT01424930|BG001|Baseline|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
11071854|NCT01424930|BG002|Baseline|Total|Total of all reporting groups
11071855|NCT01424930|FG000|Participant Flow|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
11071856|NCT01424930|FG001|Participant Flow|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
11071857|NCT01424930|OG000|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
11071858|NCT01424930|OG001|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
11071859|NCT01424930|EG000|Reported Event|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
11071860|NCT01424930|EG001|Reported Event|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
11071861|NCT01424943|BG000|Baseline|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
11071862|NCT01424943|BG001|Baseline|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
11071863|NCT01424943|BG002|Baseline|Total|Total of all reporting groups
11071864|NCT01424943|FG000|Participant Flow|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
11071865|NCT01424943|FG001|Participant Flow|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
11071866|NCT01424943|OG000|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
11071867|NCT01424943|OG001|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
11091846|NCT01536418|OG000|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
11071868|NCT01424943|EG000|Reported Event|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
11071869|NCT01424943|EG001|Reported Event|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
11071870|NCT01425190|BG000|Baseline|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071871|NCT01425190|BG001|Baseline|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071872|NCT01425190|BG002|Baseline|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071873|NCT01425190|BG003|Baseline|Total|Total of all reporting groups
11071874|NCT01425190|FG000|Participant Flow|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071875|NCT01425190|FG001|Participant Flow|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
10887631|NCT00501891|EG000|Reported Event|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
11071876|NCT01425190|FG002|Participant Flow|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071877|NCT01425190|OG000|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071878|NCT01425190|OG001|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071879|NCT01425190|OG002|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071880|NCT01425190|EG000|Reported Event|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071881|NCT01425190|EG001|Reported Event|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071882|NCT01425190|EG002|Reported Event|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
11071883|NCT01425203|BG000|Baseline|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
11071884|NCT01425203|BG001|Baseline|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
11071885|NCT01425203|BG002|Baseline|Total|Total of all reporting groups
11071886|NCT01425203|FG000|Participant Flow|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
11071887|NCT01425203|FG001|Participant Flow|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
11071888|NCT01425203|FG002|Participant Flow|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
11071889|NCT01425203|OG000|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
11071890|NCT01425203|OG001|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
11071891|NCT01425203|OG002|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
11071892|NCT01425203|EG000|Reported Event|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
11071893|NCT01425203|EG001|Reported Event|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
11071894|NCT01425203|EG002|Reported Event|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
11071895|NCT01425229|BG000|Baseline|Bosentan|Bosentan PK
11071896|NCT01425229|FG000|Participant Flow|Bosentan|Bosentan pharmacokinetics
11071897|NCT01425229|OG000|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
11071898|NCT01425229|OG001|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
11071899|NCT01425229|OG002|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
11071900|NCT01425229|EG000|Reported Event|Bosentan After First Dose|Bosentan PK after first dose
11071901|NCT01425229|EG001|Reported Event|Bosentan at Steady-state|Bosentan PK at steady-state
11071902|NCT01425229|EG002|Reported Event|Bosentan During Clarithromycin|Bosentan PK during clarithromycin
11071903|NCT01425268|BG000|Baseline|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
11071904|NCT01425268|BG001|Baseline|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
11071905|NCT01425268|BG002|Baseline|Total|Total of all reporting groups
11071906|NCT01425268|FG000|Participant Flow|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
11071907|NCT01425268|FG001|Participant Flow|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
11071908|NCT01425268|OG000|Outcome|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
11071909|NCT01425268|OG001|Outcome|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
11071910|NCT01425268|EG000|Reported Event|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
11071911|NCT01425268|EG001|Reported Event|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
11071912|NCT01425307|BG000|Baseline|Standard Therapy|Standard Therapy of monthly transfusions
11071913|NCT01425307|BG001|Baseline|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
11071914|NCT01425307|BG002|Baseline|Total|Total of all reporting groups
11071915|NCT01425307|FG000|Participant Flow|Standard Therapy|Standard Therapy of monthly transfusions
11071916|NCT01425307|FG001|Participant Flow|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
11071917|NCT01425307|OG000|Outcome|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
11071918|NCT01425307|OG001|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
11071919|NCT01425307|OG000|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
11071920|NCT01425307|OG001|Outcome|Treatment Arm|Hydroxyurea will be provided as capsules and liquid
11071921|NCT01425307|EG000|Reported Event|Standard Therapy|Standard Therapy of monthly transfusions
11071922|NCT01425307|EG001|Reported Event|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
11071923|NCT01425359|BG000|Baseline|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
11071924|NCT01425359|BG001|Baseline|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
11071925|NCT01425359|BG002|Baseline|Total|Total of all reporting groups
11071926|NCT01425359|FG000|Participant Flow|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
11071927|NCT01425359|FG001|Participant Flow|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
11071928|NCT01425359|OG000|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
11071929|NCT01425359|OG001|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
11071930|NCT01425359|OG001|Outcome|Qualifying Phase: Participants Entered a 2-week Washout Period|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
11071931|NCT01425359|EG000|Reported Event|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
11071932|NCT01425359|EG001|Reported Event|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
11071933|NCT01425463|BG000|Baseline|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
11071934|NCT01425463|BG001|Baseline|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
11071935|NCT01425463|BG002|Baseline|Total|Total of all reporting groups
11071936|NCT01425463|FG000|Participant Flow|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
11071937|NCT01425463|FG001|Participant Flow|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
11071938|NCT01425463|OG000|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
11071939|NCT01425463|OG001|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
11071940|NCT01425463|EG000|Reported Event|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
11071941|NCT01425463|EG001|Reported Event|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
11071942|NCT01425528|BG000|Baseline|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
11071943|NCT01425528|BG001|Baseline|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
11071944|NCT01425528|BG002|Baseline|Total|Total of all reporting groups
11071945|NCT01425528|FG000|Participant Flow|Cohort 1|This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.
11071946|NCT01425528|FG001|Participant Flow|Cohort 2|Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.
11071947|NCT01425528|OG000|Outcome|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
11071948|NCT01425528|OG001|Outcome|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
11071949|NCT01425528|EG000|Reported Event|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
11071950|NCT01425528|EG001|Reported Event|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
11071951|NCT01425281|BG000|Baseline|Absorb BVS™|Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.
11071952|NCT01425281|BG001|Baseline|XIENCE™|Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
11071953|NCT01425281|BG002|Baseline|Total|Total of all reporting groups
10887632|NCT00501943|BG000|Baseline|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
10887633|NCT00501943|BG001|Baseline|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
10887634|NCT00501943|BG002|Baseline|Total|Total of all reporting groups
11071954|NCT01425281|FG000|Participant Flow|Absorb BVS™|Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: ABSORB bioresorbable vascular scaffold (Absorb BVS) implantation in the treatment of coronary artery disease.
11071955|NCT01425281|FG001|Participant Flow|XIENCE™|Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
11071956|NCT01425281|OG000|Outcome|Absorb BVS™|Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.
11071957|NCT01425281|OG001|Outcome|XIENCE™|Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
11071958|NCT01425281|OG000|Outcome|Absorb BVS™|Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: ABSORB bioresorbable vascular scaffold (Absorb BVS) implantation in the treatment of coronary artery disease.
11071959|NCT01425281|EG000|Reported Event|XIENCE™|Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
11071960|NCT01425281|EG001|Reported Event|Absorb BVS™|Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.
11071961|NCT01425632|BG000|Baseline|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
11071962|NCT01425632|BG001|Baseline|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
11071963|NCT01425632|BG002|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
11071964|NCT01425632|BG003|Baseline|Total|Total of all reporting groups
11071965|NCT01425632|FG000|Participant Flow|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
11071966|NCT01425632|FG001|Participant Flow|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
11071967|NCT01425632|FG002|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
11071968|NCT01425632|OG000|Outcome|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
11071969|NCT01425632|OG001|Outcome|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
11071970|NCT01425632|OG002|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
11071971|NCT01425632|EG000|Reported Event|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
11071972|NCT01425632|EG001|Reported Event|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
11071973|NCT01425632|EG002|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
11071974|NCT01425723|BG000|Baseline|rFIXFc (Participants From 9HB02PED)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of >5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.
11071975|NCT01425723|BG001|Baseline|rFIXFc (Participants From 998HB102)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of > 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
11071976|NCT01425723|BG002|Baseline|Total|Total of all reporting groups
11071977|NCT01425723|FG000|Participant Flow|rFIXFc (Participants From 9HB02PED)|Participants received Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) intravenously (IV) according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of greater than (>)5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.
11071978|NCT01425723|FG001|Participant Flow|rFIXFc (Participants From 998HB102)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 international units per kilogram (IU/kg) to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of > 5 percent (%), if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
11091847|NCT01536418|OG001|Outcome|GSK1605786A 500 mg,Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
11091848|NCT01536418|OG001|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
11071979|NCT01425723|OG000|Outcome|rFIXFc (9HB02PED [<6 Years Old])|Participants with less than (<) 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of > 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.
11071980|NCT01425723|OG001|Outcome|rFIXFc (9HB02PED [6 to <12 Years])|Participants with 6 to <12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of > 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.
11071981|NCT01425723|OG002|Outcome|rFIXFc (Participants From 998HB102)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of > 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
11071982|NCT01425723|OG000|Outcome|rFIXFc (9HB02PED [<6 Years Old Age Cohort])|Participants with < 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of > 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.
11071983|NCT01425723|OG001|Outcome|rFIXFc (9HB02PED [6 to <12 Years Old Age Cohort])|Participants with 6 to <12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of > 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.
11071984|NCT01425723|OG002|Outcome|rFIXFc (Participants From Study 998HB102)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of > 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
11071985|NCT01425723|OG000|Outcome|rFIXFc (Participants From 9HB02PED)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of >5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.
11091849|NCT01536418|EG000|Reported Event|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
11091850|NCT01536418|EG001|Reported Event|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
11091851|NCT01536496|BG000|Baseline|Control (INR, PTT, Fibrinogen, D-dimer)|
11091852|NCT01536496|BG001|Baseline|Test (r-TEG)|
11091853|NCT01536496|BG002|Baseline|Total|Total of all reporting groups
11071986|NCT01425723|OG001|Outcome|rFIXFc (Participants From 998HB102)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of > 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
11071987|NCT01425723|EG000|Reported Event|rFIXFc (Participants From 9HB02PED)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of >5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.
11071988|NCT01425723|EG001|Reported Event|rFIXFc (Participants From 998HB102)|Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of > 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
11071989|NCT01425723|EG002|Reported Event|Overall rFIXFc (Participants From 9HB02PED and 998HB102)|All participants who received rFIXFc drug in study 9HB01EXT, from studies 9HB02PED and 998HB102 (combined). AEs emergent during major surgical/rehabilitation periods are excluded and are presented as separate groups.
11071990|NCT01425723|EG003|Reported Event|rFIXFc (Participants From 9HB02PED in Surgery Subgroup)|Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFIXFc as appropriate for the type of surgery. Participants returned to a regular rFIXFc regimen once all dosing for the postoperative rehabilitation period had been completed.
11071991|NCT01425723|EG004|Reported Event|rFIXFc (Participants From 998HB102 in Surgery Subgroup)|Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFIXFc as appropriate for the type of surgery. Participants returned to a regular rFIXFc regimen once all dosing for the postoperative rehabilitation period had been completed.
11071992|NCT01425749|BG000|Baseline|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11071993|NCT01425749|BG001|Baseline|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11071994|NCT01425749|BG002|Baseline|Total|Total of all reporting groups
11071995|NCT01425749|FG000|Participant Flow|Arm A: Intramuscular Injections|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11071996|NCT01425749|FG001|Participant Flow|Arm B: Intradermal/Subcutaneous Injections|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11071997|NCT01425749|OG000|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11071998|NCT01425749|OG001|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11071999|NCT01425749|OG000|Outcome|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11072000|NCT01425749|OG001|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11233720|NCT02430870|FG001|Participant Flow|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11072001|NCT01425749|OG000|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11072002|NCT01425749|EG000|Reported Event|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11072003|NCT01425749|EG001|Reported Event|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
11072004|NCT01425801|BG000|Baseline|Overall Population|Safety population defined as all patients who were randomized and received at least one dose of investigational medicinal product
11072005|NCT01425801|FG000|Participant Flow|Sequence A|Salbutamol 400 μg - LAS100977 0.313 μg - Placebo - LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 1.25 μg
11072006|NCT01425801|FG001|Participant Flow|Sequence B|LAS100977 0.313 μg - LAS100977 0.625 μg - Salbutamol 400 μg - LAS100977 1.25 μg - Placebo - LAS100977 2.5 μg
11072007|NCT01425801|FG002|Participant Flow|Sequence C|LAS100977 0.625 μg - LAS100977 1.25 μg - LAS100977 0.313 μg - LAS100977 2.5 μg - Salbutamol 400 μg - Placebo
11072008|NCT01425801|FG003|Participant Flow|Sequence D|LAS100977 1.25 μg - LAS100977 2.5 μg - LAS100977 0.625 μg - Placebo - LAS100977 0.313 μg - Salbutamol 400 μg
11072009|NCT01425801|FG004|Participant Flow|Sequence E|LAS100977 2.5 μg - Placebo - LAS100977 1.25 μg - Salbutamol 400 μg - LAS100977 0.625 μg - LAS100977 0.313 μg
11072010|NCT01425801|FG005|Participant Flow|Sequence F|Placebo - Salbutamol 400 μg - LAS100977 2.5 μg - LAS100977 0.313 μg - LAS100977 1.25 μg - LAS100977 0.625 μg
11072011|NCT01425801|OG000|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
11072012|NCT01425801|OG001|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
11072013|NCT01425801|OG002|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
11072014|NCT01425801|OG003|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
11072015|NCT01425801|OG004|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
11072016|NCT01425801|OG005|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
11072017|NCT01425801|EG000|Reported Event|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
11072018|NCT01425801|EG001|Reported Event|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
11072019|NCT01425801|EG002|Reported Event|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
11072020|NCT01425801|EG003|Reported Event|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
11072021|NCT01425801|EG004|Reported Event|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
11072022|NCT01425801|EG005|Reported Event|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
11072023|NCT01425814|BG000|Baseline|Overall Population|All patients who were randomized and received at least one dose of investigational medicinal product
11072024|NCT01425814|FG000|Participant Flow|Sequence A|Indacaterol 150 μg - LAS100977 10 μg - Placebo - LAS100977 0.625 μg - LAS100977 5 μg- LAS100977 2.5 μg
11072025|NCT01425814|FG001|Participant Flow|Sequence B|LAS100977 10 μg - LAS100977 0.625 μg - Indacaterol 150 μg - LAS100977 2.5 μg - Placebo - LAS100977 5 μg
11072026|NCT01425814|FG002|Participant Flow|Sequence C|LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 10 μg - LAS100977 5 μg - Indacaterol 150 μg - Placebo
11072027|NCT01425814|FG003|Participant Flow|Sequence D|LAS100977 2.5 μg - LAS100977 5 μg - LAS100977 0.625 μg - Placebo - LAS100977 10 μg - Indacaterol 150 μg
11072028|NCT01425814|FG004|Participant Flow|Sequence E|LAS100977 5 μg - Placebo - LAS100977 2.5 μg - Indacaterol 150 μg - LAS100977 0.625 μg - LAS100977 10 μg
11072029|NCT01425814|FG005|Participant Flow|Sequence F|Placebo - Indacaterol 150 μg - LAS100977 5 μg - LAS100977 10 μg - LAS100977 2.5 μg - LAS100977 0.625 μg
11072030|NCT01425814|OG000|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
11072031|NCT01425814|OG001|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
10887635|NCT00501943|FG000|Participant Flow|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
11072032|NCT01425814|OG002|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
11072033|NCT01425814|OG003|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
11072034|NCT01425814|OG004|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
11072035|NCT01425814|OG005|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
11072036|NCT01425814|EG000|Reported Event|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
11072037|NCT01425814|EG001|Reported Event|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
11072038|NCT01425814|EG002|Reported Event|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
11072039|NCT01425814|EG003|Reported Event|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
11072040|NCT01425814|EG004|Reported Event|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
11072041|NCT01425814|EG005|Reported Event|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
10887636|NCT00501943|FG001|Participant Flow|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
11072042|NCT01425853|BG000|Baseline|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
11072043|NCT01425853|BG001|Baseline|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
11072044|NCT01425853|BG002|Baseline|Total|Total of all reporting groups
11072045|NCT01425853|FG000|Participant Flow|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
11072046|NCT01425853|FG001|Participant Flow|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
11072047|NCT01425853|OG000|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
11072048|NCT01425853|OG001|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
11072049|NCT01425853|OG000|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
11072050|NCT01425853|EG000|Reported Event|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
11072051|NCT01425853|EG001|Reported Event|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
11072052|NCT01425879|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11072053|NCT01425879|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11072054|NCT01425879|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11072055|NCT01425879|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11072056|NCT01426009|BG000|Baseline|Total Particiants|total of all participants in the study
11072057|NCT01426009|FG000|Participant Flow|Total|"total subjects which includes:EP-101 via nebulizer (eFlow®), Tiotropium bromide via (Spiriva® Handihaler®), Ipratropium bromide Inhalation Solution via Handihaler® DPI , and Placebo EP-101,"
11072058|NCT01426009|OG000|Outcome|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
11072059|NCT01426009|OG001|Outcome|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
11072060|NCT01426009|OG002|Outcome|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
11072061|NCT01426009|OG003|Outcome|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
11072062|NCT01426009|OG004|Outcome|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
11072063|NCT01426009|OG005|Outcome|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
11072064|NCT01426009|OG006|Outcome|Placebo|"Placebo~Placebo : Placebo administered once daily for 7 days"
11072065|NCT01426009|EG000|Reported Event|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
11072066|NCT01426009|EG001|Reported Event|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
11072067|NCT01426009|EG002|Reported Event|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
11072068|NCT01426009|EG003|Reported Event|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
11072069|NCT01426009|EG004|Reported Event|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
11072070|NCT01426009|EG005|Reported Event|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
11072071|NCT01426009|EG006|Reported Event|Placebo|"Placebo~Placebo : Placebo administered once daily for 7 days"
11072072|NCT01426191|BG000|Baseline|Xinzhijun|xinzhijun:third generation beta-lactam cephalosporin and beta lactamase inhibitors (BLIs)
11072073|NCT01426191|FG000|Participant Flow|Xinzhijun|"1.5-3.0g,iv,bid or tid for 5-12 days~xinzhijun: durg:Cefotaxime sodium and sulbactam sodium for injection(2:1)~1.5-3.0g,iv,bid or tid for 5-12 days;~Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days"
11072074|NCT01426191|OG000|Outcome|Xinzhijun|"1.5-3.0g,iv,bid or tid for 5-12 days~xinzhijun: durg:Cefotaxime sodium and sulbactam sodium for injection(2:1)~1.5-3.0g,iv,bid or tid for 5-12 days;~Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days"
11072075|NCT01426191|EG000|Reported Event|Xinzhijun|"1.5-3.0g,iv,bid or tid for 5-12 days~xinzhijun: durg:Cefotaxime sodium and sulbactam sodium for injection(2:1)~1.5-3.0g,iv,bid or tid for 5-12 days;~Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days"
11072076|NCT01426217|BG000|Baseline|Control|Control arm using standard of care operating room procedures and equipment
11072077|NCT01426217|BG001|Baseline|Experimental Group|Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.
11072078|NCT01426217|BG002|Baseline|Total|Total of all reporting groups
11072079|NCT01426217|FG000|Participant Flow|Control|Control arm using standard of care operating room procedures and equipment.
11072080|NCT01426217|FG001|Participant Flow|Experimental Group|Implementation of passive bundle which includes HubScrub and DOCIt device into the operating room environment.
11072081|NCT01426217|OG000|Outcome|Control|Control arm using standard of care operating room procedures and equipment
11072082|NCT01426217|OG001|Outcome|PSI Experimental|"Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.~Problem Solving Innovations (PSI) Passive Bundle: PSI Medical HubScrub, PSI Medical DocIt"
11072083|NCT01426217|OG000|Outcome|Entire Population|"Experimental and Control groups were combined for analysis.~Control arm used standard of care operating room procedures and equipment.~Experimental arm implemented a of passive bundle which includes HubScrub and DocIt device into the operating room environment."
11072084|NCT01426217|EG000|Reported Event|Entire Population|"Experimental and Control groups were combined for analysis.~Control arm used standard of care operating room procedures and equipment.~Experimental arm implemented a of passive bundle which includes HubScrub and DocIt device into the operating room environment."
11072085|NCT01426230|BG000|Baseline|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
11072086|NCT01426230|BG001|Baseline|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
11072087|NCT01426230|BG002|Baseline|Total|Total of all reporting groups
11072088|NCT01426230|FG000|Participant Flow|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
11072089|NCT01426230|FG001|Participant Flow|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
11072090|NCT01426230|OG000|Outcome|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
11072091|NCT01426230|OG001|Outcome|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
11072092|NCT01426230|EG000|Reported Event|Open Label - Both Cohorts|
11072093|NCT01426269|BG000|Baseline|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)~Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
11072094|NCT01426269|FG000|Participant Flow|Doxycycline and Metronidazole Regimen|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)~Oral Doxycycline and Topical Metronidazole: During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area.~After Period 1, subjects who meet criteria for phase 2 will be randomized to receive doxycycline or placebo during phase 2"
11072095|NCT01426269|FG001|Participant Flow|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)~Oral Doxycycline: During phase 2 week 12 - week 52: Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
11072096|NCT01426269|FG002|Participant Flow|Placebo|"Subjects will receive placebo during phase 2 (week 12 - week 52)~Placebo: During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning"
11072097|NCT01426269|OG000|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
11072098|NCT01426269|OG001|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
11072099|NCT01426269|OG000|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
11072100|NCT01426269|OG001|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
11072101|NCT01426269|OG002|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
11072102|NCT01426269|OG003|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
11072103|NCT01426269|EG000|Reported Event|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)~Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
11072104|NCT01426269|EG001|Reported Event|Period 2: Oral Doxycycline|"Subjects will receive oral doxycycline during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
11072105|NCT01426269|EG002|Reported Event|Period 2: Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: period 2, placebo, oral, one capsule daily in the morning"
11072106|NCT01426347|BG000|Baseline|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
11072107|NCT01426347|BG001|Baseline|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
11072108|NCT01426347|BG002|Baseline|Total|Total of all reporting groups
11072109|NCT01426347|FG000|Participant Flow|Placebo Group|"Rheumatoid Arthritis (RA) patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
11072110|NCT01426347|FG001|Participant Flow|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
11072111|NCT01426347|OG000|Outcome|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
11072112|NCT01426347|OG001|Outcome|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
11072113|NCT01426347|EG000|Reported Event|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
11072114|NCT01426347|EG001|Reported Event|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
11072115|NCT01426360|BG000|Baseline|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
11072116|NCT01426360|BG001|Baseline|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
11072117|NCT01426360|BG002|Baseline|Total|Total of all reporting groups
11072118|NCT01426360|FG000|Participant Flow|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
11072119|NCT01426360|FG001|Participant Flow|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
11072120|NCT01426360|OG000|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
11072121|NCT01426360|OG001|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
11072122|NCT01426360|EG000|Reported Event|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
11072123|NCT01426360|EG001|Reported Event|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
11072124|NCT01426373|BG000|Baseline|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11072125|NCT01426373|FG000|Participant Flow|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11072126|NCT01426373|OG000|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11072127|NCT01426373|OG000|Outcome|Month 3 After Last Treatment|
11072128|NCT01426373|OG001|Outcome|Month 12 After Last Treatment|
11072129|NCT01426373|EG000|Reported Event|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11072130|NCT01426386|BG000|Baseline|FE 999049 5.2 µg|Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
11072131|NCT01426386|BG001|Baseline|FE 999049 6.9 µg|Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
11072132|NCT01426386|BG002|Baseline|FE 999049 8.6 µg|Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
11072133|NCT01426386|BG003|Baseline|FE 999049 10.3 µg|Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
11072134|NCT01426386|BG004|Baseline|FE 999049 12.1 µg|Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
11072135|NCT01426386|BG005|Baseline|GONAL-F 11 µg|Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
11072136|NCT01426386|BG006|Baseline|Total|Total of all reporting groups
11072137|NCT01426386|FG000|Participant Flow|FE 999049 5.2 µg|Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
11072138|NCT01426386|FG001|Participant Flow|FE 999049 6.9 µg|Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
11072139|NCT01426386|FG002|Participant Flow|FE 999049 8.6 µg|Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
11072140|NCT01426386|FG003|Participant Flow|FE 999049 10.3 µg|Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
11072141|NCT01426386|FG004|Participant Flow|FE 999049 12.1 µg|Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
11072142|NCT01426386|FG005|Participant Flow|GONAL-F 11 µg|Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
11072143|NCT01426386|OG000|Outcome|FE 999049 5.2 µg|Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
11072144|NCT01426386|OG001|Outcome|FE 999049 6.9 µg|Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
11072145|NCT01426386|OG002|Outcome|FE 999049 8.6 µg|Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
11072146|NCT01426386|OG003|Outcome|FE 999049 10.3 µg|Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
11072147|NCT01426386|OG004|Outcome|FE 999049 12.1 µg|Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
11072148|NCT01426386|OG005|Outcome|GONAL-F 11 µg|Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
11072149|NCT01426386|EG000|Reported Event|FE 999049 5.2 µg|Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
11072150|NCT01426386|EG001|Reported Event|FE 999049 6.9 µg|Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
11072151|NCT01426386|EG002|Reported Event|FE 999049 8.6 µg|Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
11072152|NCT01426386|EG003|Reported Event|FE 999049 10.3 µg|Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
11072153|NCT01426386|EG004|Reported Event|FE 999049 12.1 µg|Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
11072154|NCT01426386|EG005|Reported Event|GONAL-F 11 µg|Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
11072155|NCT01426412|BG000|Baseline|0.03 mg/kg LY3015014 IV|A single dose of 0.03 milligrams per kilogram (mg/kg) LY3015014 administered intravenously (IV).
11072156|NCT01426412|BG001|Baseline|0.1 mg/kg LY3015014 IV|A single dose of 0.1 mg/kg LY3015014 administered IV.
11072157|NCT01426412|BG002|Baseline|0.3 mg/kg LY3015014 IV|A single dose of 0.3 mg/kg LY3015014 administered IV.
11072158|NCT01426412|BG003|Baseline|1.0 mg/kg LY3015014 IV|A single dose of 1.0 mg/kg LY3015014 administered IV.
11072159|NCT01426412|BG004|Baseline|3.0 mg/kg LY3015014 IV|A single dose of 3.0 mg/kg LY3015014 administered IV.
11072160|NCT01426412|BG005|Baseline|3.0 mg/kg LY3015014 SC|A single dose of 3.0 mg/kg LY3015014 administered SC.
11072161|NCT01426412|BG006|Baseline|3.0 mg/kg LY3015014 SC +Statin|A single dose of 3.0 mg/kg LY3015014 administered subcutaneously (SC) with a statin add-on dose.
11072162|NCT01426412|BG007|Baseline|10.0 mg/kg LY3015014 IV|A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
11072163|NCT01426412|BG008|Baseline|Placebo|A single dose of placebo administered IV or SC with a statin add-on dose.
11072164|NCT01426412|BG009|Baseline|Total|Total of all reporting groups
11072165|NCT01426412|FG000|Participant Flow|0.03 mg/kg LY3015014 IV|A single dose of 0.03 milligrams per kilogram (mg/kg) LY3015014 administered intravenously (IV).
11072166|NCT01426412|FG001|Participant Flow|0.1 mg/kg LY3015014 IV|A single dose of 0.1 mg/kg LY3015014 administered IV.
11072167|NCT01426412|FG002|Participant Flow|0.3 mg/kg LY3015014 IV|A single dose of 0.3 mg/kg LY3015014 administered IV.
11072168|NCT01426412|FG003|Participant Flow|1.0 mg/kg LY3015014 IV|A single dose of 1.0 mg/kg LY3015014 administered IV.
11072169|NCT01426412|FG004|Participant Flow|3.0 mg/kg LY3015014 IV|A single dose of 3.0 mg/kg LY3015014 administered IV.
11072170|NCT01426412|FG005|Participant Flow|3.0 mg/kg LY3015014 SC|A single dose of 3.0 mg/kg LY3015014 administered SC.
11072171|NCT01426412|FG006|Participant Flow|3.0 mg/kg LY3015014 SC +Statin|A single dose of 3.0 mg/kg LY3015014 administered subcutaneously (SC) with a statin add-on dose.
11072172|NCT01426412|FG007|Participant Flow|10.0 mg/kg LY3015014 IV|A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
11072173|NCT01426412|FG008|Participant Flow|Placebo|A single dose of placebo administered IV or SC with a statin add-on dose.
11072174|NCT01426412|OG000|Outcome|Placebo|A single dose of placebo administered IV or SC with a statin add-on dose.
11072175|NCT01426412|OG001|Outcome|0.03 mg/kg LY3015014 IV|A single dose of 0.03 mg/kg LY3015014 administered IV.
11072176|NCT01426412|OG002|Outcome|0.1 mg/kg LY3015014 IV|A single dose of 0.1 mg/kg LY3015014 administered IV.
11072177|NCT01426412|OG003|Outcome|0.3 mg/kg LY3015014 IV|A single dose of 0.3 mg/kg LY3015014 administered IV.
11072178|NCT01426412|OG004|Outcome|1.0 mg/kg LY3015014 IV|A single dose of 1.0 mg/kg LY3015014 administered IV.
11072179|NCT01426412|OG005|Outcome|3.0 mg/kg LY3015014 IV|A single dose of 3.0 mg/kg LY3015014 administered IV.
11072180|NCT01426412|OG006|Outcome|3.0 mg/kg LY3015014 SC|A single dose of 3.0 mg/kg LY3015014 administered SC.
11072181|NCT01426412|OG007|Outcome|3.0 mg/kg LY3015014 SC +Statin|A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
11072182|NCT01426412|OG008|Outcome|10.0 mg/kg LY3015014 IV|A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
11072183|NCT01426412|OG000|Outcome|0.03 mg/kg LY3015014 IV|A single dose of 0.03 mg/kg LY3015014 administered IV.
11072184|NCT01426412|OG001|Outcome|0.1 mg/kg LY3015014 IV|A single dose of 0.1 mg/kg LY3015014 administered IV.
11072185|NCT01426412|OG002|Outcome|0.3 mg/kg LY3015014 IV|A single dose of 0.3 mg/kg LY3015014 administered IV.
11072186|NCT01426412|OG003|Outcome|1.0 mg/kg LY3015014 IV|A single dose of 1.0 mg/kg LY3015014 administered IV.
11072187|NCT01426412|OG004|Outcome|3.0 mg/kg LY3015014 IV|A single dose of 3.0 mg/kg LY3015014 administered IV.
11072188|NCT01426412|OG005|Outcome|10.0 mg/kg LY3015014 IV Non-Japanese|A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese participants.
11072189|NCT01426412|OG006|Outcome|10.0 mg/kg LY3015014 IV Japanese|A single dose of 10.0 mg/kg LY3015014 administered IV to Japanese participants.
11072190|NCT01426412|OG007|Outcome|3.0 mg/kg LY3015014 SC|A single dose of 3.0 mg/kg LY3015014 administered SC.
10887637|NCT00501943|OG000|Outcome|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
10887638|NCT00501943|OG001|Outcome|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
11072191|NCT01426412|OG008|Outcome|3.0 mg/kg LY3015014 SC +Statin|A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
11072192|NCT01426412|OG008|Outcome|10.0 mg/kg LY3015014 IV Japanese|A single dose of 10.0 mg/kg LY3015014 administered IV to Japanese participants.
11072193|NCT01426412|OG009|Outcome|10.0 mg/kg LY3015014 IV Non-Japanese|A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese participants.
11072194|NCT01426412|EG000|Reported Event|0.03 mg/kg LY3015014 IV|A single dose of 0.03 mg/kg LY3015014 administered IV.
11072195|NCT01426412|EG001|Reported Event|0.1 mg/kg LY3015014 IV|A single dose of 0.1 mg/kg LY3015014 administered IV.
11072196|NCT01426412|EG002|Reported Event|0.3 mg/kg LY3015014 IV|A single dose of 0.3 mg/kg LY3015014 administered IV.
11072197|NCT01426412|EG003|Reported Event|1.0 mg/kg LY3015014 IV|A single dose of 1.0 mg/kg LY3015014 administered IV.
11072198|NCT01426412|EG004|Reported Event|3.0 mg/kg LY3015014 IV|A single dose of 3.0 mg/kg LY3015014 administered IV.
11072199|NCT01426412|EG005|Reported Event|3.0 mg/kg LY3015014 SC|A single dose of 3.0 mg/kg LY3015014 administered SC.
11072200|NCT01426412|EG006|Reported Event|3.0 mg/kg LY3015014 SC +Statin|A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
11072201|NCT01426412|EG007|Reported Event|10.0 mg/kg LY3015014 IV|A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
11072202|NCT01426412|EG008|Reported Event|Placebo|A single dose of placebo administered IV or SC with a statin add-on dose.
11072203|NCT01426425|BG000|Baseline|mITT Set|The modified intent-to-treat (mITT) set.
11072204|NCT01426425|FG000|Participant Flow|All Participants|All subjects enrolled into the study.
11072205|NCT01426425|OG000|Outcome|mITT Set|The modified intent-to-treat (mITT) set.
11072206|NCT01426425|OG000|Outcome|mITT Subjects With Acute Procedural Success|The modified intent-to-treat (mITT) subjects who had acute procedural success with cryoablation for the treatment of AVNRT.
11072207|NCT01426425|EG000|Reported Event|mITT Set|Subjects in the modified intent-to-treat (mITT) set.
11072208|NCT01426438|BG000|Baseline|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
11072209|NCT01426438|BG001|Baseline|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
11072210|NCT01426438|BG002|Baseline|Total|Total of all reporting groups
11072211|NCT01426438|FG000|Participant Flow|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
11072212|NCT01426438|FG001|Participant Flow|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
11072213|NCT01426438|OG000|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
11072214|NCT01426438|OG001|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
11072215|NCT01426438|EG000|Reported Event|Arm A: Extended-release Niacin With Aspirin|Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
11072216|NCT01426438|EG001|Reported Event|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
11072217|NCT01426581|BG000|Baseline|Teach To Goal|"Intervention: Teach to Goal~Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072218|NCT01426581|BG001|Baseline|Brief Intervention|"Brief Intervention~Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072219|NCT01426581|BG002|Baseline|Total|Total of all reporting groups
11072220|NCT01426581|FG000|Participant Flow|Teach To Goal|"Intervention: Teach to Goal~Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072221|NCT01426581|FG001|Participant Flow|Brief Intervention:|"Brief Intervention~Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072222|NCT01426581|OG000|Outcome|Teach to Goal|"Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072223|NCT01426581|OG001|Outcome|Brief Intervention|"Brief Intervention~Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072224|NCT01426581|OG000|Outcome|Teach To Goal|"Intervention: Teach to Goal~Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072225|NCT01426581|OG001|Outcome|Brief Intervention:|"Brief Intervention~Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072226|NCT01426581|EG000|Reported Event|Educational Intervention A|"Intervention: Teach to Goal~Teach-To-Goal: Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
11072227|NCT01426581|EG001|Reported Event|Educational Intervention B:|"Brief Intervention~Brief Intervention: Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
10887639|NCT00501943|OG000|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
11072228|NCT01426763|BG000|Baseline|Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1|SC injection of 1000 Units of CINRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks
11072229|NCT01426763|BG001|Baseline|SC CINRYZE With rHuPH20 Dose Level 2|SC injection of 2000 Units of CINRYZE with ~40,000 Units of rHuPH20 twice weekly for two weeks
11072230|NCT01426763|BG002|Baseline|Total|Total of all reporting groups
11072231|NCT01426763|FG000|Participant Flow|Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1|SC injection of 1000 Units of CINRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks
11072232|NCT01426763|FG001|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 2|SC injection of 2000 Units of CINRYZE with ~40,000 Units of rHuPH20 twice weekly for two weeks
11072233|NCT01426763|OG000|Outcome|Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1|SC injection of 1000 Units of CINRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks
11072234|NCT01426763|OG001|Outcome|SC CINRYZE With rHuPH20 Dose Level 2|SC injection of 2000 Units of CINRYZE with ~40,000 Units of rHuPH20 twice weekly for two weeks
11072235|NCT01426763|OG000|Outcome|Subcutaneous (SC) With Recombinant Human Hyaluronidase ph20 (rHuPH20) CYNRYZE Dose 1|1000 Units of SC CYNRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks
11072236|NCT01426763|OG000|Outcome|Subcutaneous (SC) With Recombinant Human Hyaluronidase ph20 (rHuPH20) CYNRYZE Dose 1|SC injection of 1000 Units of CINRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks
11072237|NCT01426763|EG000|Reported Event|Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1|SC injection of 1000 Units of CINRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks
11072238|NCT01426763|EG001|Reported Event|SC CINRYZE With rHuPH20 Dose Level 2|SC injection of 2000 Units of CINRYZE with ~40,000 Units of rHuPH20 twice weekly for two weeks
11072239|NCT01426789|BG000|Baseline|Secukinumab|10 mg/kg intravenous (I.V.)
11072240|NCT01426789|BG001|Baseline|Placebo|Placebo i.v.
11072241|NCT01426789|BG002|Baseline|Total|Total of all reporting groups
10887640|NCT00501943|OG001|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
10887641|NCT00501943|EG000|Reported Event|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
11072242|NCT01426789|FG000|Participant Flow|Secukinumab|10 mg/kg intravenous (I.V.)
11072243|NCT01426789|FG001|Participant Flow|Placebo|Placebo i.v.
11072244|NCT01426789|FG002|Participant Flow|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
11072245|NCT01426789|FG003|Participant Flow|Group 2|Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment
11072246|NCT01426789|FG004|Participant Flow|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
11072247|NCT01426789|FG005|Participant Flow|Group 4|Part 1: placebo; Part 2: no study treatment
11072248|NCT01426789|OG000|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
11072249|NCT01426789|OG001|Outcome|Placebo|Placebo i.v.
11072250|NCT01426789|EG000|Reported Event|Secukinumab|10mg/kg i.v.
11072251|NCT01426789|EG001|Reported Event|Placebo|Placebo i.v.
11072252|NCT01426789|EG002|Reported Event|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
10887642|NCT00501943|EG001|Reported Event|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
11072253|NCT01426789|EG003|Reported Event|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
11072254|NCT01426828|BG000|Baseline|Arm A|"Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of KLH only vaccine.~CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously"
11072255|NCT01426828|BG001|Baseline|Arm B|"Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)~CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously"
11072256|NCT01426828|BG002|Baseline|Total|Total of all reporting groups
11072257|NCT01426828|FG000|Participant Flow|Arm A|"Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of KLH only vaccine.~CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously"
11072258|NCT01426828|FG001|Participant Flow|Arm B|"Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)~CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously"
11072259|NCT01426828|OG000|Outcome|Arm A|"Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of KLH only vaccine.~CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously"
11072260|NCT01426828|OG001|Outcome|Arm B|"Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)~CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously"
11072261|NCT01426828|EG000|Reported Event|Arm A|"Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of KLH only vaccine.~CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously"
11072262|NCT01426828|EG001|Reported Event|Arm B|"Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)~CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously"
11072263|NCT01426854|BG000|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
11072264|NCT01426854|BG001|Baseline|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
11072265|NCT01426854|BG002|Baseline|Total|Total of all reporting groups
11072266|NCT01426854|FG000|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
11072267|NCT01426854|FG001|Participant Flow|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
11072268|NCT01426854|OG000|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
11072269|NCT01426854|OG001|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
11072270|NCT01426854|EG000|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
10887643|NCT00501969|BG000|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
10887644|NCT00501969|FG000|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
11072271|NCT01426854|EG001|Reported Event|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
11150236|NCT01876485|OG001|Outcome|Arm 2: Enhanced Usual Care (EUC)|"The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.~Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility."
11072272|NCT01426867|BG000|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
11072273|NCT01426867|BG001|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
11072274|NCT01426867|BG002|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
11072275|NCT01426867|BG003|Baseline|Total|Total of all reporting groups
11072276|NCT01426867|FG000|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
11072277|NCT01426867|FG001|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
11072278|NCT01426867|FG002|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
11072279|NCT01426867|OG000|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
11072280|NCT01426867|OG001|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
11072281|NCT01426867|OG002|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
11072282|NCT01426867|EG000|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
11072283|NCT01426867|EG001|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
11072284|NCT01426867|EG002|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
11072285|NCT01426958|BG000|Baseline|Overall Study|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
11072286|NCT01426958|FG000|Participant Flow|All Participants|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
11072287|NCT01426958|OG000|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
11072288|NCT01426958|OG001|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
11072289|NCT01426958|OG002|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
11072290|NCT01426958|EG000|Reported Event|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
11072291|NCT01426958|EG001|Reported Event|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
11072292|NCT01426958|EG002|Reported Event|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
11072293|NCT01427296|BG000|Baseline|OsmoPrep Tablets|Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
11072294|NCT01427296|BG001|Baseline|HalfLytely and Bisacodyl Tablet|Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
11072295|NCT01427296|BG002|Baseline|Total|Total of all reporting groups
11072296|NCT01427296|FG000|Participant Flow|OsmoPrep Tablets|Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
11072297|NCT01427296|FG001|Participant Flow|HalfLytely and Bisacodyl Tablet|Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
11072298|NCT01427296|OG000|Outcome|OsmoPrep Tablets|Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
11072299|NCT01427296|OG001|Outcome|HalfLytely and Bisacodyl Tablet|Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
11072300|NCT01427296|EG000|Reported Event|OsmoPrep Tablets|Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
11072301|NCT01427296|EG001|Reported Event|HalfLytely and Bisacodyl Tablet|Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
11072302|NCT01427309|BG000|Baseline|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
11072303|NCT01427309|BG001|Baseline|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
11072304|NCT01427309|BG002|Baseline|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
11072305|NCT01427309|BG003|Baseline|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
11072306|NCT01427309|BG004|Baseline|Total|Total of all reporting groups
11072307|NCT01427309|FG000|Participant Flow|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
11072308|NCT01427309|FG001|Participant Flow|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
11072309|NCT01427309|FG002|Participant Flow|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
11072310|NCT01427309|FG003|Participant Flow|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
11072311|NCT01427309|OG000|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
11072312|NCT01427309|OG001|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
11072313|NCT01427309|OG002|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
11072314|NCT01427309|OG003|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
11072315|NCT01427309|EG000|Reported Event|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
11072316|NCT01427309|EG001|Reported Event|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
11072317|NCT01427309|EG002|Reported Event|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
11072318|NCT01427309|EG003|Reported Event|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
11072319|NCT01427504|BG000|Baseline|Sequence 1a|Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
11072320|NCT01427504|BG001|Baseline|Sequence 1b|Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
11072321|NCT01427504|BG002|Baseline|Sequence 2a|Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
11072322|NCT01427504|BG003|Baseline|Sequence 2b|Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
11072323|NCT01427504|BG004|Baseline|Sequence 3a|Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
11072324|NCT01427504|BG005|Baseline|Sequence 3b|Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
11072325|NCT01427504|BG006|Baseline|Total|Total of all reporting groups
11072326|NCT01427504|FG000|Participant Flow|Sequence 1a|Sequence 1,2,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
11072327|NCT01427504|FG001|Participant Flow|Sequence 1b|Sequence 1,3,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
11072328|NCT01427504|FG002|Participant Flow|Sequence 2a|Sequence 2,1,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
11072329|NCT01427504|FG003|Participant Flow|Sequence 2b|Sequence 2,3,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
11072330|NCT01427504|FG004|Participant Flow|Sequence 3a|Sequence 3,1,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
11072331|NCT01427504|FG005|Participant Flow|Sequence 3b|Sequence 3,2,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
11072332|NCT01427504|OG000|Outcome|Boceprevir AUC|Geometric mean of boceprevir AUC administered alone.
11072333|NCT01427504|OG000|Outcome|Boceprevir Cmax|Geometric mean of boceprevir Cmax when administered alone.
11072334|NCT01427504|OG000|Outcome|Boceprevir C8|Geometric mean of boceprevir Cmax when administered alone.
11072335|NCT01427504|OG000|Outcome|Etravirine AUC|Geometric mean of etravirine AUC when administered alone.
11072336|NCT01427504|OG000|Outcome|Etravirine Cmax|Geometric mean of etravirine Cmax when administered alone.
11072337|NCT01427504|OG000|Outcome|Etravirine Cmin|Geometric mean of etravirine Cmin when administered alone.
11072338|NCT01427504|OG000|Outcome|Boceprevir AUC Coadministered With Etravirine|Geometric mean ratio of boceprevir AUC when coadministered with etravirine
11072339|NCT01427504|OG000|Outcome|Boceprevir Cmax Coadministered With Etravirine|Geometric mean ratio of boceprevir Cmax when coadministered with etravirine
11072340|NCT01427504|OG000|Outcome|Boceprevir C8 Coadministered With Etravirine|Geometric mean ratio of boceprevir C8 when coadministered with etravirine
11072341|NCT01427504|OG000|Outcome|Etravirine AUC Coadministered With Boceprevir|Geometric mean ratio of etravirine AUC when coadministered with boceprevir
11072342|NCT01427504|OG000|Outcome|Etravirine Cmax|Geometric mean ratio of etravirine Cmax when coadministered with boceprevir
11072343|NCT01427504|OG000|Outcome|Etravirine Cmin Coadministered With Boceprevir|Geometric mean ratio of etravirine Cmin when coadministered with boceprevir
11072344|NCT01427504|EG000|Reported Event|Boceprevir Alone|Subjects took boceprevir alone, 800 mg thrice daily, for 10-14 days.
11072345|NCT01427504|EG001|Reported Event|Etravirine Alone|Subjects took etravirine alone, 200 mg twice daily, for 10-14 days
11072346|NCT01427504|EG002|Reported Event|Boceprevir Coadministered With Etravirine|Boceprevir, 800 mg thrice daily, coadministered with etravirine, 200 mg twice daily for 10-14 days.
11072347|NCT01427517|BG000|Baseline|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
11072348|NCT01427517|BG001|Baseline|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
11072349|NCT01427517|BG002|Baseline|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
11072350|NCT01427517|BG003|Baseline|Total|Total of all reporting groups
11072351|NCT01427517|FG000|Participant Flow|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
11072352|NCT01427517|FG001|Participant Flow|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
11072353|NCT01427517|FG002|Participant Flow|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
11072354|NCT01427517|OG000|Outcome|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
11072355|NCT01427517|OG001|Outcome|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
11072356|NCT01427517|OG002|Outcome|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
11072357|NCT01427517|EG000|Reported Event|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
11072358|NCT01427517|EG001|Reported Event|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
11072359|NCT01427517|EG002|Reported Event|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
11072360|NCT01427595|BG000|Baseline|Metformin, Progesterone , Estrace|"12 weeks Metformin oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (2X) oral estrace, 0.5-1 mg once a day for seven days (2X)~Metformin: 500-2000 mg PO BID (X12 weeks)~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (X2)~estrace: oral estrogen (estrace, 0.5-1 mg once a day for seven days)- X2"
11072361|NCT01427595|FG000|Participant Flow|Metformin, Progesterone , Estrace|"12 weeks Metformin oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (2X) oral estrace, 0.5-1 mg once a day for seven days (2X)~Metformin: 500-2000 mg PO BID (X12 weeks)~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (X2)~estrace: oral estrogen (estrace, 0.5-1 mg once a day for seven days)- X2"
11072362|NCT01427595|OG000|Outcome|Metformin, Progesterone , Estrace|"12 weeks Metformin oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (2X) oral estrace, 0.5-1 mg once a day for seven days (2X)~Metformin: 500-2000 mg PO BID (X12 weeks)~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (X2)~estrace: oral estrogen (estrace, 0.5-1 mg once a day for seven days)- X2"
11072363|NCT01427595|EG000|Reported Event|Metformin, Progesterone , Estrace|"12 weeks Metformin oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (2X) oral estrace, 0.5-1 mg once a day for seven days (2X)~Metformin: 500-2000 mg PO BID (X12 weeks)~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (X2)~estrace: oral estrogen (estrace, 0.5-1 mg once a day for seven days)- X2"
11072364|NCT01427608|BG000|Baseline|Sertraline + Olanzapine|Randomized to continue with sertraline and olanzapine under double-blind conditions
11072365|NCT01427608|BG001|Baseline|Sertraline + Placebo|Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
11072366|NCT01427608|BG002|Baseline|Total|Total of all reporting groups
11072367|NCT01427608|FG000|Participant Flow|Sertraline + Olanzapine|Randomized to continue with sertraline and olanzapine under double-blind conditions
11072368|NCT01427608|FG001|Participant Flow|Sertraline + Placebo|Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
11072369|NCT01427608|OG000|Outcome|Sertraline + Olanzapine|Randomized to continue with sertraline and olanzapine under double-blind conditions
11072370|NCT01427608|OG001|Outcome|Sertraline + Placebo|Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
11072371|NCT01427608|OG000|Outcome|Sertraline + Olanzapine|"Randomized to continue with sertraline and olanzapine under double-blind conditions.~Sertraline + Olanzapine: Olanzapine 15mg/day. Adjustment of dose to 5mg/day to a maximum of 20mg/day will be permitted if necessitated by significant side-effects or clinical worsening"
11072372|NCT01427608|OG001|Outcome|Sertraline + Placebo|"Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions.~Sertraline + Placebo: Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study."
11072373|NCT01427608|EG000|Reported Event|Sertraline + Olanzapine|Randomized to continue with sertraline and olanzapine under double-blind conditions
11072374|NCT01427608|EG001|Reported Event|Sertraline + Placebo|Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
11072375|NCT01427738|BG000|Baseline|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
11072376|NCT01427738|BG001|Baseline|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
11072377|NCT01427738|BG002|Baseline|Total|Total of all reporting groups
11072378|NCT01427738|FG000|Participant Flow|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
11072379|NCT01427738|FG001|Participant Flow|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
11072380|NCT01427738|OG000|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
11072381|NCT01427738|OG001|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
11072382|NCT01427738|EG000|Reported Event|Gentian Violet|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
11072383|NCT01427738|EG001|Reported Event|Nystatin|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
11072384|NCT01427751|BG000|Baseline|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
11072385|NCT01427751|BG001|Baseline|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
11072386|NCT01427751|BG002|Baseline|Total|Total of all reporting groups
11072387|NCT01427751|FG000|Participant Flow|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
11072388|NCT01427751|FG001|Participant Flow|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
11072389|NCT01427751|OG000|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
11072390|NCT01427751|OG001|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
11072391|NCT01427751|EG000|Reported Event|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
11072392|NCT01427751|EG001|Reported Event|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
11072393|NCT01427803|BG000|Baseline|Patterns of Use User Population|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
11072394|NCT01427803|BG001|Baseline|Reasons for Misuse Interviewed Population|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
11072395|NCT01427803|BG002|Baseline|Total|Total of all reporting groups
11072396|NCT01427803|FG000|Participant Flow|Patterns of Use Cohort|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
11072397|NCT01427803|FG001|Participant Flow|Reasons for Misuse Cohort|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
11072398|NCT01427803|OG000|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
11072399|NCT01427803|EG000|Reported Event|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
11072400|NCT01427881|BG000|Baseline|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
11072401|NCT01427881|FG000|Participant Flow|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
11150237|NCT01876485|EG000|Reported Event|Arm 1: Empowering Patients in Chronic Care (EPIC)|"Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.~Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans."
10887645|NCT00501969|OG000|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
11072402|NCT01427881|OG000|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
11072403|NCT01427881|EG000|Reported Event|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
11072404|NCT01427907|BG000|Baseline|Sequence I: COS Then Sevelamer|Sequence I: Calcium Acetate Oral Solution for 4 weeks then Sevelamer Carbonate for 4 weeks
11072405|NCT01427907|BG001|Baseline|Sequence II: Sevelamer Then COS|Sevelamer Carbonate for 4 weeks then Calcium Acetate Oral Solution for 4 weeks
11072406|NCT01427907|BG002|Baseline|Total|Total of all reporting groups
11072407|NCT01427907|FG000|Participant Flow|Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks)|Patient receive Calcium Acetate Oral Solution (COS) for 4 weeks then cross over to Sevelamer tablets for 4 weeks.
11072408|NCT01427907|FG001|Participant Flow|Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks)|Patient receive Sevelamer tablets for 4 weeks, then cross over to take COS for 4 weeks.
11072409|NCT01427907|OG000|Outcome|Calcium Acetate Oral Solution|Calcium Acetate Oral Solution for periods 1 and 2
11072410|NCT01427907|OG001|Outcome|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
11072411|NCT01427907|EG000|Reported Event|Calcium Acetate Oral Solution|Sequence I: Calcium Acetate Oral Solution for periods 1 and 2
11072412|NCT01427907|EG001|Reported Event|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
11072413|NCT01427920|BG000|Baseline|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
11072414|NCT01427920|BG001|Baseline|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
11072415|NCT01427920|BG002|Baseline|Total|Total of all reporting groups
11072416|NCT01427920|FG000|Participant Flow|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
11072417|NCT01427920|FG001|Participant Flow|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
11173524|NCT02016105|EG000|Reported Event|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
10887646|NCT00501969|EG000|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
11072418|NCT01427920|OG000|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
11072419|NCT01427920|OG001|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
11072420|NCT01427920|EG000|Reported Event|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
11072421|NCT01427920|EG001|Reported Event|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
11072422|NCT01427933|BG000|Baseline|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
11072423|NCT01427933|BG001|Baseline|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
11072424|NCT01427933|BG002|Baseline|Total|Total of all reporting groups
11072425|NCT01427933|FG000|Participant Flow|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
11072426|NCT01427933|FG001|Participant Flow|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
11072427|NCT01427933|OG000|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
11072428|NCT01427933|OG001|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
11072429|NCT01427933|OG000|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
11072430|NCT01427933|EG000|Reported Event|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
11072431|NCT01427933|EG001|Reported Event|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
11072432|NCT01427972|BG000|Baseline|1.5 mg LY2623091 First Then 10 mg LY2623091|Participants received 1.5 milligram (mg) LY2623091 administered orally, once daily (QD) for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11173525|NCT02016105|EG001|Reported Event|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
11173526|NCT02016105|EG002|Reported Event|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
11173527|NCT02016105|EG003|Reported Event|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
11173528|NCT02016170|BG000|Baseline|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
11173529|NCT02016170|BG001|Baseline|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
11173530|NCT02016170|BG002|Baseline|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
11173531|NCT02016170|BG003|Baseline|Total|Total of all reporting groups
11072433|NCT01427972|BG001|Baseline|1.5 mg LY2623091 First Then 50 mg Eplerenone|Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072434|NCT01427972|BG002|Baseline|1.5 mg LY2623091 First Then 0.2 mg LY2623091|Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072435|NCT01427972|BG003|Baseline|50mg Eplerenone First Then 0.2 mg LY2623091|Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072436|NCT01427972|BG004|Baseline|50mg Eplerenone First Then 1.5 mg LY2623091|Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072437|NCT01427972|BG005|Baseline|50mg Eplerenone First Then 10 mg LY2623091|Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072438|NCT01427972|BG006|Baseline|0.2 mg LY2623091 First Then 10 mg LY2623091|Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072439|NCT01427972|BG007|Baseline|0.2 mg LY2623091 First Then 50 mg Eplerenone|Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11349074|NCT04126343|OG000|Outcome|Metabolite 2 (QT/QTc Set)|Participants received PSL (padsevonil metabolite 2) 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/QTc Set.
11072440|NCT01427972|BG008|Baseline|0.2 mg LY2623091 First Then 1.5 mg LY2623091|Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072441|NCT01427972|BG009|Baseline|10mg LY2623091 First Then 50mg Eplerenone|Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072442|NCT01427972|BG010|Baseline|10mg LY2623091 First Then 0.2 mg LY2623091|Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072443|NCT01427972|BG011|Baseline|10 mg LY2623091 First Then 1.5 mg LY2623091|Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072444|NCT01427972|BG012|Baseline|Total|Total of all reporting groups
11072445|NCT01427972|FG000|Participant Flow|1.5 mg LY2623091 First Then 10 mg LY2623091|Participants received 1.5 milligram (mg) LY2623091 administered orally, once daily (QD) for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072446|NCT01427972|FG001|Participant Flow|1.5 mg LY2623091 First Then 50 mg Eplerenone|Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072447|NCT01427972|FG002|Participant Flow|1.5 mg LY2623091 First Then 0.2 mg LY2623091|Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072448|NCT01427972|FG003|Participant Flow|50mg Eplerenone First Then 0.2 mg LY2623091|Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072449|NCT01427972|FG004|Participant Flow|50mg Eplerenone First Then 1.5 mg LY2623091|Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072450|NCT01427972|FG005|Participant Flow|50mg Eplerenone First Then 10 mg LY2623091|Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072451|NCT01427972|FG006|Participant Flow|0.2 mg LY2623091 First Then 10 mg LY2623091|Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072452|NCT01427972|FG007|Participant Flow|0.2 mg LY2623091 First Then 50 mg Eplerenone|Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072453|NCT01427972|FG008|Participant Flow|0.2 mg LY2623091 First Then 1.5 mg LY2623091|Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072454|NCT01427972|FG009|Participant Flow|10mg LY2623091 First Then 50mg Eplerenone|Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072455|NCT01427972|FG010|Participant Flow|10mg LY2623091 First Then 0.2 mg LY2623091|Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
10887647|NCT00501995|BG000|Baseline|IV Cyclophosphamide (50 mg/kg)|This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)
11072456|NCT01427972|FG011|Participant Flow|10 mg LY2623091 First Then 1.5 mg LY2623091|Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
11072457|NCT01427972|OG000|Outcome|0.2 mg LY2623091|0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
11072458|NCT01427972|OG001|Outcome|1.5 mg LY2623091|1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
11072459|NCT01427972|OG002|Outcome|10 mg LY2623091|10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
11072460|NCT01427972|OG003|Outcome|50 mg Eplerenone|50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
11072461|NCT01427972|EG000|Reported Event|0.2 mg LY2623091|0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.
11072462|NCT01427972|EG001|Reported Event|1.5 mg LY2623091|1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.
11072463|NCT01427972|EG002|Reported Event|10 mg LY2623091|10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.
11072464|NCT01427972|EG003|Reported Event|50 mg Eplerenone|50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.
11072465|NCT01428024|BG000|Baseline|Restylane LipVolume|"Open label~Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and week 12."
11072466|NCT01428024|BG001|Baseline|Restylane Lip Refresh|"Open label~Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and week 12."
11072467|NCT01428024|BG002|Baseline|Total|Total of all reporting groups
11072468|NCT01428024|FG000|Participant Flow|Restylane LipVolume|"Open label~Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12."
11072469|NCT01428024|FG001|Participant Flow|Restylane Lip Refresh|"Open label~Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12."
11072470|NCT01428024|OG000|Outcome|Restylane Lip Volume|"GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline).~Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip."
11072471|NCT01428024|OG001|Outcome|Restylane Lip Refresh|"GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline).~Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip."
11072472|NCT01428024|OG000|Outcome|Restylane Lip Volume|"GEIS (Global Esthetic Improvement Scale) subject at 36 weeks (change from baseline).~Injection with Restylane Lip Volume (a Hyaluronic acid gel) with maximum 1.5 ml for each upper/lower lip."
11072473|NCT01428024|OG001|Outcome|Restylane Lip Refresh|"GEIS (Global Esthetic Improvement Scale) subject at 36 weeks (change from baseline).~Injection with Restylane Lip Refresh (a Hyaluronic acid gel) with maximum 0.5 ml for each upper/lower lip."
11072474|NCT01428024|OG000|Outcome|Restylane LipVolume|"GEIS (Global Esthetic Improvement Scale)by treating investigator at 36 weeks (change from baseline).~Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip."
11072475|NCT01428024|OG001|Outcome|Restylane Lip Refresh|"GEIS (Global Esthetic Improvement Scale)by treating investigator at 36 weeks (change from baseline).~Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip."
11072476|NCT01428024|OG000|Outcome|Restylane LipVolume|"GEIS (Global Esthetic Improvement Scale)independent evaluator at 36 weeks (change from baseline).~Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip."
11072477|NCT01428024|OG001|Outcome|Restylane Lip Refresh|"GEIS (Global Esthetic Improvement Scale)independent evaluator at 36 weeks (change from baseline).~Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip."
11072478|NCT01428024|OG000|Outcome|Restylane LipVolume|"MLFS (Medicis Lip Fullness Scale)score by live assessment performed separately by the treating and the independent investigators at 8 weeks (change from baseline).~Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip."
11072479|NCT01428024|OG000|Outcome|Restylane LipVolume|Subject satisfaction questionnaire at 8 weeks. Injection of Restylane Lip Volume (a Hyaluronic acid gel) maximum dosage of 1.5 ml per upper/lower lip.
11072480|NCT01428024|OG001|Outcome|Restylane Lip Refresh|Subject satisfaction questionnaire at 8 weeks. Injection of Restylane Lip Refresh (a Hyaluronic acid gel) maximum dosage of 0.5 ml per upper/lower lip.
11072481|NCT01428024|OG000|Outcome|Restylane Lip Volume|"Open label~Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12."
11072482|NCT01428024|OG001|Outcome|Restylane Lip Refresh|"Open label~Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12."
11072483|NCT01428024|EG000|Reported Event|Restylane LipVolume|"Open label~Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12."
11072484|NCT01428024|EG001|Reported Event|Restylane Lip Refresh|"Open label~Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12."
11072485|NCT01428063|BG000|Baseline|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
11072486|NCT01428063|BG001|Baseline|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
11072487|NCT01428063|BG002|Baseline|Daclatasvir + pegIFN-2a+ Ribavirin|Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
11072488|NCT01428063|BG003|Baseline|Total|Total of all reporting groups
11072489|NCT01428063|FG000|Participant Flow|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
11072490|NCT01428063|FG001|Participant Flow|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
11072491|NCT01428063|FG002|Participant Flow|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072492|NCT01428063|OG000|Outcome|Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR)|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
11072493|NCT01428063|OG000|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
11072494|NCT01428063|OG001|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4)|Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072495|NCT01428063|OG002|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072496|NCT01428063|OG003|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072497|NCT01428063|OG004|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072498|NCT01428063|OG005|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072499|NCT01428063|OG006|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
11072500|NCT01428063|OG007|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
11072501|NCT01428063|OG008|Outcome|DCV + pegIFN-2a+ RBV|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072502|NCT01428063|OG001|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072503|NCT01428063|OG004|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072504|NCT01428063|OG005|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072505|NCT01428063|OG008|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072506|NCT01428063|EG000|Reported Event|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks.
11072507|NCT01428063|EG001|Reported Event|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
11072508|NCT01428063|EG002|Reported Event|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
11072509|NCT01428076|BG000|Baseline|Polidocanol 1%|polidocanol injectable foam 1% concentration
11072510|NCT01428076|BG001|Baseline|Polidocanol 2%|polidocanol intravenous foam 2% concentration
11072511|NCT01428076|BG002|Baseline|Total|Total of all reporting groups
11072512|NCT01428076|FG000|Participant Flow|Polidocanol 1%|polidocanol injectable foam 1% concentration
11072513|NCT01428076|FG001|Participant Flow|Polidocanol 2%|polidocanol injectable foam 2% concentration
11072514|NCT01428076|OG000|Outcome|Males-polidocanol 1%|polidocanol injectable foam 1% concentration
11072515|NCT01428076|OG001|Outcome|Males-polidocanol 2%|polidocanol injectable foam 2% concentration
11072516|NCT01428076|OG002|Outcome|Females-polidocanol 1%|polidocanol injectable foam 1% concentration
11072517|NCT01428076|OG003|Outcome|Females- Polidocanol 2%|polidocanol injectable foam 2% concentration
11072518|NCT01428076|EG000|Reported Event|Polidocanol 1%|polidocanol injectable foam 1% concentration
11072519|NCT01428076|EG001|Reported Event|Polidocanol 2%|polidocanol injectable foam 2% concentration
11072520|NCT01428115|BG000|Baseline|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
11072521|NCT01428115|FG000|Participant Flow|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
11072522|NCT01428115|OG000|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
11072523|NCT01428115|OG000|Outcome|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
11072524|NCT01428115|EG000|Reported Event|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
11072525|NCT01428128|BG000|Baseline|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
11072526|NCT01428128|FG000|Participant Flow|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
11072527|NCT01428128|OG000|Outcome|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
11072528|NCT01428128|OG000|Outcome|Complete Blood Count|Blood is drawn at 9 days to obtain a complete blood count
11072529|NCT01428128|EG000|Reported Event|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
11173532|NCT02016170|FG000|Participant Flow|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
11173533|NCT02016170|FG001|Participant Flow|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
11072530|NCT01428193|BG000|Baseline|Flutamide, Estrace, Progesterone|"For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.~Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.~Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.~Flutamide: Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days~estrace: 0.5-1 mg once a day for seven days"
11072531|NCT01428193|FG000|Participant Flow|Flutamide, Estrace, Progesterone|"For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.~Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.~Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.~Flutamide: Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days~estrace: 0.5-1 mg once a day for seven days"
11072532|NCT01428193|OG000|Outcome|Flutamide, Estrace, Progesterone|"For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.~Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.~Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.~Flutamide: Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days~estrace: 0.5-1 mg once a day for seven days"
11072533|NCT01428193|EG000|Reported Event|Flutamide, Estrace, Progesterone|"For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.~Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.~Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.~Flutamide: Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days~estrace: 0.5-1 mg once a day for seven days"
11233721|NCT02430870|FG002|Participant Flow|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11072534|NCT01428219|BG000|Baseline|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
11072535|NCT01428219|FG000|Participant Flow|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
11072536|NCT01428219|OG000|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
11072537|NCT01428219|EG000|Reported Event|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
11072538|NCT01428245|BG000|Baseline|Progesterone, Estrace|"oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days~oral estrace, 0.5-1 mg once a day for seven days~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days~Estrace (estrogen): oral estrace, 0.5-1 mg once a day for seven days"
11072539|NCT01428245|FG000|Participant Flow|Progesterone, Estrace|"oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days~oral estrace, 0.5-1 mg once a day for seven days~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days~Estrace (estrogen): oral estrace, 0.5-1 mg once a day for seven days"
11072540|NCT01428245|OG000|Outcome|Progesterone, Estrace|"oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days~oral estrace, 0.5-1 mg once a day for seven days~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days~Estrace (estrogen): oral estrace, 0.5-1 mg once a day for seven days"
11072541|NCT01428245|EG000|Reported Event|Progesterone, Estrace|"oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days~oral estrace, 0.5-1 mg once a day for seven days~Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days~Estrace (estrogen): oral estrace, 0.5-1 mg once a day for seven days"
11072542|NCT01428258|BG000|Baseline|GMP Diet-AA Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.~Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
11072543|NCT01428258|BG001|Baseline|AA Diet - GMP Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.~Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
11072544|NCT01428258|BG002|Baseline|Total|Total of all reporting groups
11072545|NCT01428258|FG000|Participant Flow|GMP Diet-AA Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.~Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
11072546|NCT01428258|FG001|Participant Flow|AA Diet - GMP Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.~Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
11173534|NCT02016170|FG002|Participant Flow|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
11072547|NCT01428258|OG000|Outcome|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
11072548|NCT01428258|OG001|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
11072549|NCT01428258|OG000|Outcome|GMP Diet|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
11072550|NCT01428258|OG000|Outcome|GMP Diet/GMP Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made from glycomacropeptide .
11072551|NCT01428258|OG001|Outcome|AA Diet/AA Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
11072552|NCT01428258|OG000|Outcome|Phe Concentration in Plasma, Ion Exchange Chromatography|Blood was collected by venipuncture at 3 to 4 time points, plasma was isolated and the concentration of Phe was determined by ion exchange chromatography.
11072553|NCT01428258|OG001|Outcome|Phe Concentration in Dried Blood Spots, Tandem Mass Spec|Subjects spotted their blood on filter paper at the same time as plasma was obtained at 3 or 4 time periods, dried blood spots were obtained, and analyzed for Phe concentration using tandem mass spectrometry.
11072554|NCT01428258|OG000|Outcome|GMP Diet/GMP Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.
11072555|NCT01428258|OG000|Outcome|GMP Diet/GMP Medical Foods|The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.
11072556|NCT01428258|OG001|Outcome|AA Diet/AA Medical Foods|The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
11072557|NCT01428258|EG000|Reported Event|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
11072558|NCT01428258|EG001|Reported Event|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
11072559|NCT01428336|BG000|Baseline|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
11072560|NCT01428336|BG001|Baseline|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
11072561|NCT01428336|BG002|Baseline|Total|Total of all reporting groups
11072562|NCT01428336|FG000|Participant Flow|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
11072563|NCT01428336|FG001|Participant Flow|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
11072564|NCT01428336|OG000|Outcome|Patients + Volunteers|Every participant underwent three ACTH stimulation test and one Insulin tolerance test.
11072565|NCT01428336|OG000|Outcome|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
11072566|NCT01428336|OG001|Outcome|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
11072567|NCT01428336|EG000|Reported Event|1ug Cortrosyn Dose Stimulation Test|"Subjects will undergo an ACTH stimulation test using a dose of 1 ug cotrosyn~ACTH stimulation test: 1 ug cortrosyn dose~1 ug cortrosyn test: Subjects will undergo an ACTH test using a 1 ug dose cortrosyn"
11335678|NCT03554629|EG005|Reported Event|Dispo-Med (Oral/Nasal)|"8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant.~Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following"
11072568|NCT01428336|EG001|Reported Event|250 ug Cortrosyn Dose Stimulation Test|"Subjects will undergo an ACTH stimulation test using 250 ug cortrosyn dose~250 ug ACTH stimulation test: ACTH stimulation test will be done using 250 ug cortrosyn dose"
11072569|NCT01428336|EG002|Reported Event|25 ug Cortrosyn Stimulation Test|"Subjects will undergo an ACTH stimulation test using a 25 ug cortosyn dose~25 ug Cortrosyn stimulation test: ACTH stimulation test using a 25 ug cortrosyn dose"
11072570|NCT01428336|EG003|Reported Event|Insulin Tolerance Test|"Subjects will undergo an Insulin Tolerance Test~Insulin tolerance test: subjects will undergo an insulin tolerance test"
11072571|NCT01428453|BG000|Baseline|Placebo Once Daily|Participants randomized to receive oral placebo tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
11072572|NCT01428453|BG001|Baseline|Rilapladib 250 mg Once Daily|Participants randomized to receive oral rilapladib 250 mg tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
11072573|NCT01428453|BG002|Baseline|Total|Total of all reporting groups
11072574|NCT01428453|FG000|Participant Flow|Placebo Once Daily|Participants randomized to receive oral placebo tablet once daily following breakfast for a period of 24 weeks. In addition, to their stable background therapy consisting of an acetylcholinesterase inhibitor (AChEI) and/or memantine.
11072575|NCT01428453|FG001|Participant Flow|Rilapladib 250 mg Once Daily|Participants randomized to receive oral rilapladib 250 milligrams (mg) tablet once daily following breakfast for a period of 24 weeks. In addition, to their stable background therapy consisting of an AChEI and/or memantine.
11072576|NCT01428453|OG000|Outcome|Placebo Once Daily|Participants randomized to receive oral placebo tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
11072577|NCT01428453|OG001|Outcome|Rilapladib 250 mg Once Daily|Participants randomized to receive oral rilapladib 250 mg tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
11072578|NCT01428453|OG000|Outcome|Placebo Once Daily|Participants randomized to receive oral rilapladib 250 mg tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
11072579|NCT01428453|OG001|Outcome|Rilapladib 250 mg Once Daily|Participants randomized to receive oral placebo tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
11072580|NCT01428453|EG000|Reported Event|Placebo Once Daily|Participants randomized to receive oral placebo tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
11072581|NCT01428453|EG001|Reported Event|Rilapladib 250mg Once Daily|Participants randomized to receive oral rilapladib 250 mg tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
11072582|NCT01428583|BG000|Baseline|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
11072583|NCT01428583|FG000|Participant Flow|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
11072584|NCT01428583|OG000|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
11072585|NCT01428583|EG000|Reported Event|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
11072586|NCT01428661|BG000|Baseline|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
11072587|NCT01428661|BG001|Baseline|Placebo|Placebo capsules, PO daily for 8 weeks
11072588|NCT01428661|BG002|Baseline|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
11072589|NCT01428661|BG003|Baseline|Total|Total of all reporting groups
11072590|NCT01428661|FG000|Participant Flow|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
11072591|NCT01428661|FG001|Participant Flow|Placebo|Placebo capsules, PO daily for 8 weeks
11072592|NCT01428661|FG002|Participant Flow|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
11072593|NCT01428661|OG000|Outcome|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
11072594|NCT01428661|OG001|Outcome|Placebo|Placebo capsules, PO daily for 8 weeks
11072595|NCT01428661|OG002|Outcome|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
11072596|NCT01428661|EG000|Reported Event|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
11072597|NCT01428661|EG001|Reported Event|Placebo|Placebo capsules, PO daily for 8 weeks
11072598|NCT01428661|EG002|Reported Event|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
11072599|NCT01428713|BG000|Baseline|All Study Participants|"Group A: TA first, then COCP:~Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP.~Group B: COCP first, then TA:~Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP.~Subsequently, patients who initially received COCP, received TA."
11072600|NCT01428713|FG000|Participant Flow|Group A: TA First, Then COCP|"Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP."
11072601|NCT01428713|FG001|Participant Flow|Group B: COCP First, Then TA|"Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between COCP and TA.~Subsequently, patients who initially received COCP, received TA. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles."
11072602|NCT01428713|OG000|Outcome|Group: TA|Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
11072603|NCT01428713|OG001|Outcome|Group: COCP|Patients received COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles.
11072604|NCT01428713|EG000|Reported Event|Tranexamic Acid (TA)|"Patients received oral tranexamic acid at 1300 mg three times each day on days 1 to 5 of menstrual cycle for 3 cycles. The mean age of the study population was 14.2 years. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP and patients who initially received COCP, then received TA."
11072605|NCT01428713|EG001|Reported Event|Combined Oral Contraceptives (COCP)|COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between medications.
11072606|NCT01428765|BG000|Baseline|All Patients|
11072607|NCT01428765|FG000|Participant Flow|All Patients|
11072608|NCT01428765|OG000|Outcome|All Patients|
11072609|NCT01428765|EG000|Reported Event|All Patients|
11072610|NCT01428882|BG000|Baseline|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
11173535|NCT02016170|OG000|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
11072611|NCT01428882|BG001|Baseline|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
11072612|NCT01428882|BG002|Baseline|Total|Total of all reporting groups
11072613|NCT01428882|FG000|Participant Flow|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
11072614|NCT01428882|FG001|Participant Flow|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
11072615|NCT01428882|OG000|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
11072616|NCT01428882|OG001|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
11072617|NCT01428882|EG000|Reported Event|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
11072618|NCT01428882|EG001|Reported Event|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
11072619|NCT01429051|BG000|Baseline|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
11072620|NCT01429051|FG000|Participant Flow|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
11072621|NCT01429051|OG000|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
11072622|NCT01429051|OG001|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
11072623|NCT01429051|OG000|Outcome|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
11072624|NCT01429051|OG000|Outcome|Titration Phase|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase.
11072625|NCT01429051|OG001|Outcome|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
11072626|NCT01429051|OG002|Outcome|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
11072627|NCT01429051|EG000|Reported Event|Titration Phase|Participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I).
11072628|NCT01429051|EG001|Reported Event|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
11072629|NCT01429051|EG002|Reported Event|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
11072630|NCT01429064|BG000|Baseline|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
11072631|NCT01429064|BG001|Baseline|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072632|NCT01429064|BG002|Baseline|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072633|NCT01429064|BG003|Baseline|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072634|NCT01429064|BG004|Baseline|Total|Total of all reporting groups
11173536|NCT02016170|OG001|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
11072635|NCT01429064|FG000|Participant Flow|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
11072636|NCT01429064|FG001|Participant Flow|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072637|NCT01429064|FG002|Participant Flow|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072638|NCT01429064|FG003|Participant Flow|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11227328|NCT02382640|BG002|Baseline|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
11072639|NCT01429064|OG000|Outcome|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
11072640|NCT01429064|OG001|Outcome|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072641|NCT01429064|OG002|Outcome|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072642|NCT01429064|OG003|Outcome|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072643|NCT01429064|EG000|Reported Event|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
11072644|NCT01429064|EG001|Reported Event|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072645|NCT01429064|EG002|Reported Event|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072646|NCT01429064|EG003|Reported Event|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
11072647|NCT01429077|BG000|Baseline|Levodopa|
11072648|NCT01429077|BG001|Baseline|Inactive Pill|
11072649|NCT01429077|BG002|Baseline|Total|Total of all reporting groups
11072650|NCT01429077|FG000|Participant Flow|Levodopa|The study drug (100 mg levodopa / 25 mg carbidopa), was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
11072651|NCT01429077|FG001|Participant Flow|Inactive Pill|The inactive pill was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
11072652|NCT01429077|OG000|Outcome|Levodopa/Carbidopa|
11072653|NCT01429077|OG001|Outcome|Inactive Pill|
11072654|NCT01429077|EG000|Reported Event|Levodopa|
11072655|NCT01429077|EG001|Reported Event|Inactive Pill|
11072656|NCT01429259|BG000|Baseline|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
11072657|NCT01429259|FG000|Participant Flow|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
11072658|NCT01429259|OG000|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
11072659|NCT01429259|EG000|Reported Event|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
11072660|NCT01429272|BG000|Baseline|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
11072661|NCT01429272|BG001|Baseline|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
11072662|NCT01429272|BG002|Baseline|Placebo + Minocycline|placebo aspirin + active minocycline
11072663|NCT01429272|BG003|Baseline|Placebo + Aspirin|placebo minocycline + active aspirin
11072664|NCT01429272|BG004|Baseline|Total|Total of all reporting groups
11072665|NCT01429272|FG000|Participant Flow|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
11072666|NCT01429272|FG001|Participant Flow|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
11072667|NCT01429272|FG002|Participant Flow|Placebo + Minocycline|placebo aspirin + active minocycline
11072668|NCT01429272|FG003|Participant Flow|Placebo + Aspirin|placebo minocycline + active aspirin
11072669|NCT01429272|OG000|Outcome|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
11072670|NCT01429272|OG001|Outcome|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
11072671|NCT01429272|OG002|Outcome|Placebo + Minocycline|placebo aspirin + active minocycline
11072672|NCT01429272|OG003|Outcome|Placebo + Aspirin|placebo minocycline + active aspirin
11072673|NCT01429272|EG000|Reported Event|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
11072674|NCT01429272|EG001|Reported Event|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
11072675|NCT01429272|EG002|Reported Event|Placebo + Minocycline|placebo aspirin + active minocycline
11072676|NCT01429272|EG003|Reported Event|Placebo + Aspirin|placebo minocycline + active aspirin
11072677|NCT01429285|BG000|Baseline|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
11072678|NCT01429285|BG001|Baseline|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
11072679|NCT01429285|BG002|Baseline|Total|Total of all reporting groups
11072680|NCT01429285|FG000|Participant Flow|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
11072681|NCT01429285|FG001|Participant Flow|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
11072682|NCT01429285|OG000|Outcome|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
11072683|NCT01429285|OG001|Outcome|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
11072684|NCT01429285|EG000|Reported Event|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
11072685|NCT01429285|EG001|Reported Event|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
11072686|NCT01429298|BG000|Baseline|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
11072687|NCT01429298|BG001|Baseline|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
11072688|NCT01429298|BG002|Baseline|Total|Total of all reporting groups
11072689|NCT01429298|FG000|Participant Flow|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
11072690|NCT01429298|FG001|Participant Flow|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
11072691|NCT01429298|OG000|Outcome|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
11072692|NCT01429298|OG001|Outcome|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
11072693|NCT01429298|EG000|Reported Event|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
11072694|NCT01429298|EG001|Reported Event|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
11072695|NCT01429350|BG000|Baseline|IV rtPA|"IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg~intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg"
11072696|NCT01429350|BG001|Baseline|IV rtPA and IA Penumbra System|"Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System~Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device"
11072697|NCT01429350|BG002|Baseline|Total|Total of all reporting groups
11072698|NCT01429350|FG000|Participant Flow|IV rtPA|"IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg~intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg"
11072699|NCT01429350|FG001|Participant Flow|IV rtPA and IA Penumbra System|"Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System~Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device"
11072700|NCT01429350|OG000|Outcome|IV rtPA|"IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg~intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg"
11173537|NCT02016170|EG000|Reported Event|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
11072701|NCT01429350|OG001|Outcome|IV rtPA and IA Penumbra System|"Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System~Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device"
11072702|NCT01429350|EG000|Reported Event|IV rtPA|"IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg~intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg"
11072703|NCT01429350|EG001|Reported Event|IV rtPA and IA Penumbra System|"Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System~Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device"
11072704|NCT01429441|BG000|Baseline|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
11072705|NCT01429441|BG001|Baseline|Sham|Subjects in the sham group received a single sham injection
11072706|NCT01429441|BG002|Baseline|Total|Total of all reporting groups
11072707|NCT01429441|FG000|Participant Flow|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
11072708|NCT01429441|FG001|Participant Flow|Sham|Subjects in the sham group received a single sham injection
11072709|NCT01429441|OG000|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
11072710|NCT01429441|OG001|Outcome|Sham|Subjects in the sham group received a single sham injection
11072711|NCT01429441|EG000|Reported Event|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
11072712|NCT01429441|EG001|Reported Event|Sham|Subjects in the sham group received a single sham injection
11072713|NCT01429454|BG000|Baseline|Soybean-Corn Blend Capsule|"The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them.~Placebo: The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day."
11072714|NCT01429454|BG001|Baseline|Omega 3 Long Chain Fatty Acid|"The Omega-3 Fatty Acid compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.~Omega-3 Long Chain Fatty Acid: : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA."
11072715|NCT01429454|BG002|Baseline|Total|Total of all reporting groups
11072716|NCT01429454|FG000|Participant Flow|Soybean-Corn Blend Capsule|"The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them.~Placebo: The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day."
11072717|NCT01429454|FG001|Participant Flow|Omega 3 Long Chain Fatty Acid|"The Omega-3 Fatty Acid compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.~Omega-3 Long Chain Fatty Acid: : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA."
11072718|NCT01429454|OG000|Outcome|Omega 3 Fatty Acid|Omega 3 Fatty Acid Supplementation
11072719|NCT01429454|OG001|Outcome|Placebo|Soybean/corn blend
11072720|NCT01429454|OG001|Outcome|Placebo|Soybean-Corn Blend Capsule
11072721|NCT01429454|EG000|Reported Event|Soybean-Corn Blend Capsule|"The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them.~Placebo: The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day."
11072722|NCT01429454|EG001|Reported Event|Omega 3 Long Chain Fatty Acid|"The Omega-3 Fatty Acid compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.~Omega-3 Long Chain Fatty Acid: : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA."
11072723|NCT01429532|BG000|Baseline|Group I|1.8-mm-incision-size phacoemulsification system
11072724|NCT01429532|BG001|Baseline|Group II|2.2-mm-incision-size phacoemulsification system
11072725|NCT01429532|BG002|Baseline|Group III|3.0-mm-incision-size phacoemulsification system
11072726|NCT01429532|BG003|Baseline|Total|Total of all reporting groups
11072727|NCT01429532|FG000|Participant Flow|Group I|1.8-mm-incision-size phacoemulsification system
11072728|NCT01429532|FG001|Participant Flow|Group II|2.2-mm-incision-size phacoemulsification system
11072729|NCT01429532|FG002|Participant Flow|Group III|3.0-mm-incision-size phacoemulsification system
11072730|NCT01429532|OG000|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
11072731|NCT01429532|OG001|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
11072732|NCT01429532|OG002|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
11072733|NCT01429532|EG000|Reported Event|Group I|1.8-mm-incision-size phacoemulsification system
11072734|NCT01429532|EG001|Reported Event|Group II|2.2-mm-incision-size phacoemulsification system
11072735|NCT01429532|EG002|Reported Event|Group III|3.0-mm-incision-size phacoemulsification system
11072736|NCT01429584|BG000|Baseline|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
11072737|NCT01429584|BG001|Baseline|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
11072738|NCT01429584|BG002|Baseline|Total|Total of all reporting groups
11072739|NCT01429584|FG000|Participant Flow|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
11072740|NCT01429584|FG001|Participant Flow|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
11072741|NCT01429584|OG000|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
11072742|NCT01429584|OG001|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
11072743|NCT01429584|EG000|Reported Event|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
11072744|NCT01429584|EG001|Reported Event|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
11072745|NCT01429623|BG000|Baseline|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
11072746|NCT01429623|BG001|Baseline|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
11072747|NCT01429623|BG002|Baseline|Total|Total of all reporting groups
11072748|NCT01429623|FG000|Participant Flow|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
11072749|NCT01429623|FG001|Participant Flow|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
11072750|NCT01429623|OG000|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
11072751|NCT01429623|OG001|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
11072752|NCT01429623|EG000|Reported Event|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
11072753|NCT01429623|EG001|Reported Event|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
11072754|NCT01429792|BG000|Baseline|Pegylated Interferon Alfa 2a (Peginterferon)|Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
11072755|NCT01429792|FG000|Participant Flow|Pegylated Interferon Alfa 2a (Peginterferon)|Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
11072756|NCT01429792|OG000|Outcome|Pegylated Interferon Alfa 2a (Peginterferon)|Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
11072757|NCT01429792|EG000|Reported Event|Pegylated Interferon Alfa 2a (Peginterferon)|Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.
11072758|NCT01429987|BG000|Baseline|Plecanatide 0.3 mg|Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
11072759|NCT01429987|BG001|Baseline|Plecanatide 1.0 mg|Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
11072760|NCT01429987|BG002|Baseline|Plecanatide 3.0 mg|Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
11072761|NCT01429987|BG003|Baseline|Placebo|Subjects received placebo orally for 12 consecutive weeks
11072762|NCT01429987|BG004|Baseline|Total|Total of all reporting groups
11072763|NCT01429987|FG000|Participant Flow|Plecanatide 0.3 mg|Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
11072764|NCT01429987|FG001|Participant Flow|Plecanatide 1.0 mg|Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
11072765|NCT01429987|FG002|Participant Flow|Plecanatide 3.0 mg|Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
11072766|NCT01429987|FG003|Participant Flow|Placebo|Subjects received placebo orally for 12 consecutive weeks
11072767|NCT01429987|OG000|Outcome|Plecanatide 0.3 mg|Subjects received plecanatide 0.3 mg for 12 consecutive weeks
11072768|NCT01429987|OG001|Outcome|Plecanatide 1.0 mg|Subjects received plecanatide 1.0 mg for 12 consecutive weeks
11072769|NCT01429987|OG002|Outcome|Plecanatide 3.0 mg|Subjects received plecanatide 3.0 mg for 12 consecutive weeks
11072770|NCT01429987|OG003|Outcome|Placebo|Subjects received placebo for 12 consecutive weeks
11072771|NCT01429987|EG000|Reported Event|Plecanatide 0.3 mg|Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
11072772|NCT01429987|EG001|Reported Event|Plecanatide 1.0 mg|Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
11072773|NCT01429987|EG002|Reported Event|Plecanatide 3.0 mg|Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
11072774|NCT01429987|EG003|Reported Event|Placebo|Subjects received placebo orally for 12 consecutive weeks
11072775|NCT01430091|BG000|Baseline|Participants|Total Number of Study Participants
11072776|NCT01430091|FG000|Participant Flow|Participants|Received 5 milligrams (mg) prasugrel as either the clinical tablet or as an orally disintegrating tablet (ODT).
11072777|NCT01430091|OG000|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
11072778|NCT01430091|OG001|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
11072779|NCT01430091|OG002|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
11072780|NCT01430091|OG003|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
11072781|NCT01430091|OG004|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
11072782|NCT01430091|OG000|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole approximately 180 milliliters (ml) with water.
11072783|NCT01430091|OG001|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating table (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
11072784|NCT01430091|EG000|Reported Event|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
11072785|NCT01430091|EG001|Reported Event|ODT (Top of Tongue)|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
11072786|NCT01430091|EG002|Reported Event|ODT (Juice Chaser)|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
11072787|NCT01430091|EG003|Reported Event|ODT (Chew and Swallow)|5-mg prasugrel ODT chewed and swallowed, no liquid given.
11072788|NCT01430091|EG004|Reported Event|ODT (Under Tongue)|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
11072789|NCT01430104|BG000|Baseline|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
11072790|NCT01430104|FG000|Participant Flow|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
11072791|NCT01430104|OG000|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
11072792|NCT01430104|OG000|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
11072793|NCT01430104|OG000|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide planned dose during 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
11072794|NCT01430104|OG000|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
11072795|NCT01430104|EG000|Reported Event|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
11072796|NCT01430130|BG000|Baseline|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
11072797|NCT01430130|FG000|Participant Flow|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
11072798|NCT01430130|OG000|Outcome|Treated Side|Half of the revised incision was treated with the embrace device.
11072799|NCT01430130|OG001|Outcome|Control Side|Half of the revised incision was treated according to the investigator's standard of care. Participant served as his own control.
11072800|NCT01430130|EG000|Reported Event|Treated Side|Half of the revised incision was treated with the embrace device.
11072801|NCT01430130|EG001|Reported Event|Control Side|Half of the revised incision was treated according to the investigator's standard of care. Participant served as his own control.
11072802|NCT01430169|BG000|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
11072803|NCT01430169|FG000|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg (First Injection is administered on Day 1 and the second Injection is administered on Day 2)"
11072804|NCT01430169|OG000|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
11072805|NCT01430169|EG000|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
11072806|NCT01430182|BG000|Baseline|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
11072807|NCT01430182|BG001|Baseline|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
11072808|NCT01430182|BG002|Baseline|Total|Total of all reporting groups
11072809|NCT01430182|FG000|Participant Flow|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
11072810|NCT01430182|FG001|Participant Flow|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
11072811|NCT01430182|OG000|Outcome|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
11072812|NCT01430182|OG001|Outcome|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
11072813|NCT01430182|EG000|Reported Event|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
11072814|NCT01430182|EG001|Reported Event|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
11072815|NCT01430299|BG000|Baseline|OsteoSurg 300|Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
11072816|NCT01430299|BG001|Baseline|rhBMP-2|Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
11072817|NCT01430299|BG002|Baseline|Total|Total of all reporting groups
11072818|NCT01430299|FG000|Participant Flow|OsteoSurg 300|Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
11072819|NCT01430299|FG001|Participant Flow|rhBMP-2|Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
11072820|NCT01430299|OG000|Outcome|OsteoSurg 300|Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
11072821|NCT01430299|OG001|Outcome|rhBMP-2|Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
11072822|NCT01430299|EG000|Reported Event|OsteoSurg 300|Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
11072823|NCT01430299|EG001|Reported Event|rhBMP-2|Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
11072824|NCT01430325|BG000|Baseline|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
11072825|NCT01430325|BG001|Baseline|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
11072826|NCT01430325|BG002|Baseline|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
11072827|NCT01430325|BG003|Baseline|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
11072828|NCT01430325|BG004|Baseline|Total|Total of all reporting groups
11072829|NCT01430325|FG000|Participant Flow|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
11072830|NCT01430325|FG001|Participant Flow|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
11072831|NCT01430325|FG002|Participant Flow|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
11072832|NCT01430325|FG003|Participant Flow|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
11072833|NCT01430325|OG000|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
11072834|NCT01430325|OG001|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
11072835|NCT01430325|OG002|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
11072836|NCT01430325|OG003|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
11173538|NCT02016170|EG001|Reported Event|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
11072837|NCT01430325|EG000|Reported Event|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
11072838|NCT01430325|EG001|Reported Event|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
11072839|NCT01430325|EG002|Reported Event|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
11072840|NCT01430325|EG003|Reported Event|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
11072841|NCT01430403|BG000|Baseline|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
11072842|NCT01430403|BG001|Baseline|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
11072843|NCT01430403|BG002|Baseline|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
11072844|NCT01430403|BG003|Baseline|Total|Total of all reporting groups
11173539|NCT02016170|EG002|Reported Event|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
11072845|NCT01430403|FG000|Participant Flow|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
11072846|NCT01430403|FG001|Participant Flow|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
11072847|NCT01430403|FG002|Participant Flow|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
11072848|NCT01430403|OG000|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
11072849|NCT01430403|OG001|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
11072850|NCT01430403|OG000|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
11072851|NCT01430403|OG001|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
11072852|NCT01430403|OG000|Outcome|Samples With Exacerbations|These nasal mucus samples were associated with an exacerbation (defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day)
11072853|NCT01430403|OG001|Outcome|Samples Without Exacerbations|These nasal mucus samples were not associated with an exacerbation (defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day)
11072854|NCT01430403|OG000|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
11072855|NCT01430403|OG001|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
11072856|NCT01430403|EG000|Reported Event|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
11072857|NCT01430403|EG001|Reported Event|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
11072858|NCT01430403|EG002|Reported Event|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
11072859|NCT01430442|BG000|Baseline|Treatment A: Rimegepant, 10 mg|Participants received a single dose (one capsule) of rimegepant 10 mg orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072860|NCT01430442|BG001|Baseline|Treatment B: Rimegepant, 25 mg|Participants received a single dose (one capsule) of rimegepant 25 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072861|NCT01430442|BG002|Baseline|Treatment C: Rimegepant, 75 mg|Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072862|NCT01430442|BG003|Baseline|Treatment D: Rimegepant, 150 mg|Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072863|NCT01430442|BG004|Baseline|Treatment E: Rimegepant, 300 mg|Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072864|NCT01430442|BG005|Baseline|Treatment F: Rimegepant, 600 mg|Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072865|NCT01430442|BG006|Baseline|Treatment P: Rimegepant Placebo-Matching Capsules|Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
11072866|NCT01430442|BG007|Baseline|Treatment G: Sumatriptan 100 mg|Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
11072867|NCT01430442|BG008|Baseline|Total|Total of all reporting groups
11072868|NCT01430442|FG000|Participant Flow|Treatment A: Rimegepant, 10 mg|Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072869|NCT01430442|FG001|Participant Flow|Treatment B: Rimegepant, 25 mg|Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072870|NCT01430442|FG002|Participant Flow|Treatment C: Rimegepant, 75 mg|Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072871|NCT01430442|FG003|Participant Flow|Treatment D: Rimegepant, 150 mg|Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072872|NCT01430442|FG004|Participant Flow|Treatment E: Rimegepant, 300 mg|Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072873|NCT01430442|FG005|Participant Flow|Treatment F: Rimegepant, 600 mg|Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072874|NCT01430442|FG006|Participant Flow|Treatment P: Rimegepant Placebo-Matching Capsules|Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
11072875|NCT01430442|FG007|Participant Flow|Treatment G: Sumatriptan 100 mg|Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
11072876|NCT01430442|OG000|Outcome|Treatment A: Rimegepant, 10 mg|Participants received a single dose (one capsule) of rimegepant 10 mg orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072877|NCT01430442|OG001|Outcome|Treatment B: Rimegepant, 25 mg|Participants received a single dose (one capsule) of rimegepant 25 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072878|NCT01430442|OG002|Outcome|Treatment C: Rimegepant, 75 mg|Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072879|NCT01430442|OG003|Outcome|Treatment D: Rimegepant, 150 mg|Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072880|NCT01430442|OG004|Outcome|Treatment E: Rimegepant, 300 mg|Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072881|NCT01430442|OG005|Outcome|Treatment F: Rimegepant, 600 mg|Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072882|NCT01430442|OG006|Outcome|Treatment P: Rimegepant Placebo-Matching Capsules|Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
11072883|NCT01430442|OG007|Outcome|Treatment G: Sumatriptan 100 mg|Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
11072884|NCT01430442|EG000|Reported Event|Treatment A: Rimegepant, 10 mg|Participants received a single dose (one capsule) of rimegepant 10 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072885|NCT01430442|EG001|Reported Event|Treatment B: Rimegepant, 25 mg|Participants received a single dose (one capsule) of rimegepant 25 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072886|NCT01430442|EG002|Reported Event|Treatment C: Rimegepant, 75 mg|Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072887|NCT01430442|EG003|Reported Event|Treatment D: Rimegepant, 150 mg|Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072888|NCT01430442|EG004|Reported Event|Treatment E: Rimegepant, 300 mg|Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072889|NCT01430442|EG005|Reported Event|Treatment F: Rimegepant, 600 mg|Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
11072890|NCT01430442|EG006|Reported Event|Treatment P: Rimegepant Placebo-Matching Capsules|Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
11072891|NCT01430442|EG007|Reported Event|Treatment G: Sumatriptan 100 mg|Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
11072892|NCT01430455|BG000|Baseline|Tranylcypromine|"Active, open-label tranylcypromine treatment~Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"
11072893|NCT01430455|FG000|Participant Flow|Tranylcypromine|"Active, open-label tranylcypromine treatment~Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"
11072894|NCT01430455|OG000|Outcome|Tranylcypromine|"Active, open-label tranylcypromine treatment~Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"
11072895|NCT01430455|EG000|Reported Event|Tranylcypromine|"Active, open-label tranylcypromine treatment~Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"
11072896|NCT01430468|BG000|Baseline|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
11072897|NCT01430468|BG001|Baseline|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
11072898|NCT01430468|BG002|Baseline|Total|Total of all reporting groups
11072899|NCT01430468|FG000|Participant Flow|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
11072900|NCT01430468|FG001|Participant Flow|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
11072901|NCT01430468|OG000|Outcome|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
11072902|NCT01430468|OG001|Outcome|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
11072903|NCT01430468|EG000|Reported Event|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
11072904|NCT01430468|EG001|Reported Event|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
11072905|NCT01430559|BG000|Baseline|Placebo|Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.
11072906|NCT01430559|BG001|Baseline|Meloxicam 15 mg|Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
11072907|NCT01430559|BG002|Baseline|Total|Total of all reporting groups
11072908|NCT01430559|FG000|Participant Flow|Placebo|Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.
11072909|NCT01430559|FG001|Participant Flow|Meloxicam 15 mg|Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
11072910|NCT01430559|OG000|Outcome|OA Participants|Participants with OA who responded to the WOMAC questionnaire.
11072911|NCT01430559|OG001|Outcome|Healthy Participants|Healthy participants who responded to the WOMAC questionnaire.
11072912|NCT01430559|OG000|Outcome|Placebo|Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.
11072913|NCT01430559|OG001|Outcome|Meloxicam 15 mg|Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
11072914|NCT01430559|EG000|Reported Event|Placebo|Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.
11072915|NCT01430559|EG001|Reported Event|Meloxicam 15 mg|Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
11072916|NCT01430559|EG002|Reported Event|OA Participants Not Randomized|OA participants in VAS who were not randomized to placebo or meloxicam treatment.
11072917|NCT01430559|EG003|Reported Event|OA Participants Randomized But Not Treated|OA participants who were randomized but did not receive actual placebo or meloxicam treatment.
11072918|NCT01430559|EG004|Reported Event|Healthy Participants|Healthy participants who were included in validation part of the study.
11072919|NCT01430585|BG000|Baseline|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
11072920|NCT01430585|FG000|Participant Flow|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
11072921|NCT01430585|OG000|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
11072922|NCT01430585|OG000|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion.
11072923|NCT01430585|OG001|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion.
11072924|NCT01430585|OG002|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion.
11072925|NCT01430585|OG001|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion.
11072926|NCT01430585|OG002|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion.
11072927|NCT01430585|OG003|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion.
11072928|NCT01430585|EG000|Reported Event|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
11072929|NCT01430611|BG000|Baseline|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
11072930|NCT01430611|BG001|Baseline|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
11072931|NCT01430611|BG002|Baseline|Total|Total of all reporting groups
11072932|NCT01430611|FG000|Participant Flow|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
11072933|NCT01430611|FG001|Participant Flow|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
11072934|NCT01430611|OG000|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
11072935|NCT01430611|OG001|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
11072936|NCT01430611|EG000|Reported Event|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
11072937|NCT01430611|EG001|Reported Event|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
11072938|NCT01430624|BG000|Baseline|PPRS (Completing Baseline)|Prevention of Post-Sexual Assault Stress
11072939|NCT01430624|BG001|Baseline|PIRI (Completing Baseline)|Pleasant Imagery and Relaxation Instruction
11072940|NCT01430624|BG002|Baseline|Standard Care (Completing Baseline)|Standard Care Condition completing baseline
11072941|NCT01430624|BG003|Baseline|Total|Total of all reporting groups
11072942|NCT01430624|FG000|Participant Flow|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
11072943|NCT01430624|FG001|Participant Flow|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
11072944|NCT01430624|FG002|Participant Flow|Standard Care|Treatment as usual
11072945|NCT01430624|OG000|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
11072946|NCT01430624|OG001|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
11072947|NCT01430624|OG002|Outcome|Standard Care|Treatment as usual
11072948|NCT01430624|OG000|Outcome|PPRS|Prevention of Post-Sexual Assault Stress
11072949|NCT01430624|OG001|Outcome|PIRI|Pleasant Imagery and Relaxation Condition
11072950|NCT01430624|OG002|Outcome|SC Condition|Standard Care Completing Follow-up
11072951|NCT01430624|OG002|Outcome|Standard Care|Treatment as usual which included standard care
11072952|NCT01430624|EG000|Reported Event|PPRS|Prevention of Post-Sexual Assault Stress
11072953|NCT01430624|EG001|Reported Event|PIRI|Pleasant Imagery and Relaxation Instruction
11072954|NCT01430624|EG002|Reported Event|Standard Care Condition|Standard Care Condition
11072955|NCT01430741|BG000|Baseline|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
11072956|NCT01430741|BG001|Baseline|MISSION-Vet - IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans."
11072957|NCT01430741|BG002|Baseline|Enhanced Implementation Approach GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
11072958|NCT01430741|BG003|Baseline|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans
11072959|NCT01430741|BG004|Baseline|Total|Total of all reporting groups
11072960|NCT01430741|FG000|Participant Flow|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
11072961|NCT01430741|FG001|Participant Flow|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
11072962|NCT01430741|FG002|Participant Flow|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
11072963|NCT01430741|FG003|Participant Flow|GTO MISSION Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
11072964|NCT01430741|OG000|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
11072965|NCT01430741|OG001|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
11072966|NCT01430741|OG002|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
11072967|NCT01430741|OG003|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
11072968|NCT01430741|EG000|Reported Event|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
11072969|NCT01430741|EG001|Reported Event|MISSION-Vet - IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
11072970|NCT01430741|EG002|Reported Event|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
11072971|NCT01430741|EG003|Reported Event|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans
11072972|NCT01430754|BG000|Baseline|Run-In - Not Randomized|"20 mg tasimelteon capsules~tasimelteon: 20 mg capsules, daily"
11072973|NCT01430754|BG001|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
11072974|NCT01430754|BG002|Baseline|Placebo (Randomized)|"Placebo capsules~Placebo: Placebo capsules, daily"
11072975|NCT01430754|BG003|Baseline|Total|Total of all reporting groups
11072976|NCT01430754|FG000|Participant Flow|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
11072977|NCT01430754|FG001|Participant Flow|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
11072978|NCT01430754|OG000|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
11072979|NCT01430754|OG001|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
11072980|NCT01430754|EG000|Reported Event|Total Run-In|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
11072981|NCT01430754|EG001|Reported Event|Run-In - Not Randomized|"20 mg tasimelteon capsules~tasimelteon: 20 mg capsules, daily"
11072982|NCT01430754|EG002|Reported Event|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
11072983|NCT01430754|EG003|Reported Event|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
11072984|NCT01430819|BG000|Baseline|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
11072985|NCT01430819|BG001|Baseline|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
11072986|NCT01430819|BG002|Baseline|Total|Total of all reporting groups
11072987|NCT01430819|FG000|Participant Flow|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
11072988|NCT01430819|FG001|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
11072989|NCT01430819|OG000|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
11072990|NCT01430819|OG001|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
11072991|NCT01430819|EG000|Reported Event|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
11072992|NCT01430819|EG001|Reported Event|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
11072993|NCT01431014|BG000|Baseline|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose : 15 mg"
11072994|NCT01431014|BG001|Baseline|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose : 5mg"
11072995|NCT01431014|BG002|Baseline|Total|Total of all reporting groups
11072996|NCT01431014|FG000|Participant Flow|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose : 15 mg"
11072997|NCT01431014|FG001|Participant Flow|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose : 5mg"
11072998|NCT01431014|OG000|Outcome|"DexamethasoneHigh-dose"|"15mg Dexamethasonehigh-dose : 15 mg"
11072999|NCT01431014|OG001|Outcome|"DexamethasoneLow-dose"|"5mg Dexamethasonelow-dose : 5 mg"
11073000|NCT01431014|EG000|Reported Event|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose: 5mg"
11073001|NCT01431014|EG001|Reported Event|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose: 15 mg"
11073002|NCT01431079|BG000|Baseline|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073003|NCT01431079|BG001|Baseline|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073004|NCT01431079|BG002|Baseline|Total|Total of all reporting groups
11073005|NCT01431079|FG000|Participant Flow|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073006|NCT01431079|FG001|Participant Flow|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073007|NCT01431079|OG000|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for number of people who have taken HPV vaccine before an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073008|NCT01431079|OG001|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for number of people who have taken the HPV vaccine before an education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073009|NCT01431079|OG002|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for number of people who have taken HPV vaccine after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
11073010|NCT01431079|OG003|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
11073011|NCT01431079|OG004|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for number of people who have taken HPV vaccine upto 3 months after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
11073012|NCT01431079|OG005|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
11073013|NCT01431079|OG000|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073014|NCT01431079|OG001|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data regarding education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073015|NCT01431079|OG002|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
11073016|NCT01431079|OG003|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data regarding education based on knowledge regarding HPV vaccine acceptability.
11073017|NCT01431079|OG004|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
11073018|NCT01431079|OG005|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data regarding education based on knowledge regarding HPV vaccine acceptability.
11073019|NCT01431079|OG001|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073020|NCT01431079|OG002|Outcome|Post Test Health Belief Model Based Education|This experimental group will provide post test data for an HBM based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
11073021|NCT01431079|OG003|Outcome|Post Test Knowledge Based Education|This control group will provide post test data for knowledge based education for HPV vaccine
11073022|NCT01431079|OG004|Outcome|Follow-up Health Belief Model Based Education|This experimental group will provide follow-up data for an Health belief model based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
11073023|NCT01431079|OG005|Outcome|Follow-up Knowledge Based Education|This control group will provide follow-up data for knowledge based education for HPV vaccine
11073024|NCT01431079|OG000|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide base line data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073025|NCT01431079|OG003|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
11073026|NCT01431079|OG005|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
11073027|NCT01431079|OG001|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for an education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073028|NCT01431079|OG002|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide posttest data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
11073029|NCT01431079|OG003|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for an education based on knowledge regarding HPV vaccine acceptability.
11073030|NCT01431079|OG005|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for an education based on knowledge regarding HPV vaccine acceptability.
11073031|NCT01431079|OG003|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
11073032|NCT01431079|OG005|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
11073033|NCT01431079|EG000|Reported Event|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073034|NCT01431079|EG001|Reported Event|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
11073035|NCT01431105|BG000|Baseline|Atorvasatin|"Atorvastatin dose titration to maximum tolerated dose~Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)"
11073036|NCT01431105|FG000|Participant Flow|Atorvasatin|"Atorvastatin dose titration to maximum tolerated dose~Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)"
11073037|NCT01431105|OG000|Outcome|Atorvasatin|Atorvastatin treated patients
11073038|NCT01431105|EG000|Reported Event|Atorvasatin|"Atorvastatin dose titration to maximum tolerated dose~Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)"
11073039|NCT01431131|BG000|Baseline|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
11073040|NCT01431131|BG001|Baseline|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
11073041|NCT01431131|BG002|Baseline|Total|Total of all reporting groups
11073042|NCT01431131|FG000|Participant Flow|Intrasocket Graft|Positive control, an intrasocket cancellous allograft is placed
11073043|NCT01431131|FG001|Participant Flow|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
11073044|NCT01431131|OG000|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
11073045|NCT01431131|OG001|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
11073046|NCT01431131|EG000|Reported Event|Intrasocket Graft|Positive control, an intrasocket cancellous allograft will be placed
11073047|NCT01431131|EG001|Reported Event|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
11073048|NCT01431144|BG000|Baseline|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
11073049|NCT01431144|BG001|Baseline|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
11073050|NCT01431144|BG002|Baseline|Total|Total of all reporting groups
11073051|NCT01431144|FG000|Participant Flow|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
11073052|NCT01431144|FG001|Participant Flow|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
11073053|NCT01431144|OG000|Outcome|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
11073054|NCT01431144|OG001|Outcome|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
11073055|NCT01431144|EG000|Reported Event|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
11073056|NCT01431144|EG001|Reported Event|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
11073057|NCT01431170|BG000|Baseline|Besivance Treatment Group|Subjects received Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
11073058|NCT01431170|BG001|Baseline|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
11073059|NCT01431170|BG002|Baseline|Total|Total of all reporting groups
11073060|NCT01431170|FG000|Participant Flow|Besivance Treatment Group|Subjects receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily for 10 days.
11073061|NCT01431170|FG001|Participant Flow|Polytrim Treatment Group|Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily for 10 days.
11073062|NCT01431170|OG000|Outcome|Besivance Treatment Group|Subjects received Besivance ophthalmic solution in the study eye, one drop three times a day for ten days
11073063|NCT01431170|OG001|Outcome|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution in the study eye, one drop three times daily for ten days.
11073064|NCT01431170|OG000|Outcome|Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
11073065|NCT01431170|OG001|Outcome|Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
11073066|NCT01431170|OG000|Outcome|Efficacy of Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
11073067|NCT01431170|OG001|Outcome|Efficacy of Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
11073068|NCT01431170|OG000|Outcome|Besivance Treatment Group|Number of Treatment Failures for subjects randomized to the Besivance treatment group.
11073069|NCT01431170|OG001|Outcome|Polytrim Treatment Group|Number of Treatment Failures for subjects randomized to the Polytrim treatment group.
11073070|NCT01431170|OG000|Outcome|Besivance Safety Outcomes|Number of reported medication safety issues in the Besivance Treatment Group.
11073071|NCT01431170|OG001|Outcome|Polytrim Safety Outcomes|Number of reported medication safety issues in the Polytrim Treatment Group
11073072|NCT01431170|OG000|Outcome|Besivance Treatment Group|Number of subjects treated with Besivance™ ophthalmic suspension, 0.6%, who achieved treatment success by the study close-out visit (week 16).
11073073|NCT01431170|OG001|Outcome|Polytrim Treatment Group|Number of subjects treated with Polytrim ophthalmic solution, who achieved treatment success by the study close-out visit (week 16).
11073074|NCT01431170|EG000|Reported Event|Besivance Treatment Group|Subjects randomized to the Besivance treatment group.
11073075|NCT01431170|EG001|Reported Event|Polytrim Treatment Group|Subjects randomized to the Polytrim treatment group.
11073076|NCT01431209|BG000|Baseline|Diffuse Large B-cell Lymphoma (DLBCL)|"Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Ruxolitinib Phosphate: Given PO"
11073077|NCT01431209|BG001|Baseline|Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)|"Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Ruxolitinib Phosphate: Given PO"
11073078|NCT01431209|BG002|Baseline|Total|Total of all reporting groups
11073079|NCT01431209|FG000|Participant Flow|Diffuse Large B-cell Lymphoma (DLBCL)|"Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Ruxolitinib Phosphate: Given PO"
11073080|NCT01431209|FG001|Participant Flow|Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)|"Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Ruxolitinib Phosphate: Given PO"
11073081|NCT01431209|OG000|Outcome|Diffuse Large B-cell Lymphoma (DLBCL)|"Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Ruxolitinib Phosphate: Given PO"
11073082|NCT01431209|OG001|Outcome|Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)|"Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Ruxolitinib Phosphate: Given PO"
11073083|NCT01431209|EG000|Reported Event|Diffuse Large B-cell Lymphoma (DLBCL)|"Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Ruxolitinib Phosphate: Given PO"
11073084|NCT01431209|EG001|Reported Event|Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)|"Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Ruxolitinib Phosphate: Given PO"
11073085|NCT01431274|BG000|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073086|NCT01431274|BG001|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073087|NCT01431274|BG002|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073088|NCT01431274|BG003|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073089|NCT01431274|BG004|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073090|NCT01431274|BG005|Baseline|Total|Total of all reporting groups
11073091|NCT01431274|FG000|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073092|NCT01431274|FG001|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073093|NCT01431274|FG002|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073094|NCT01431274|FG003|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073095|NCT01431274|FG004|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073096|NCT01431274|OG000|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073097|NCT01431274|OG001|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073098|NCT01431274|OG002|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073099|NCT01431274|OG003|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073100|NCT01431274|OG004|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073101|NCT01431274|EG000|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11233722|NCT02430870|FG003|Participant Flow|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11073102|NCT01431274|EG001|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073103|NCT01431274|EG002|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073104|NCT01431274|EG003|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073105|NCT01431274|EG004|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073106|NCT01431287|BG000|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
11073107|NCT01431287|BG001|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
11073108|NCT01431287|BG002|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
11073109|NCT01431287|BG003|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
11073110|NCT01431287|BG004|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
11073111|NCT01431287|BG005|Baseline|Total|Total of all reporting groups
11073112|NCT01431287|FG000|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073113|NCT01431287|FG001|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073114|NCT01431287|FG002|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073115|NCT01431287|FG003|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073116|NCT01431287|FG004|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073117|NCT01431287|OG000|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
11073118|NCT01431287|OG001|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
11073119|NCT01431287|OG002|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
11073120|NCT01431287|OG003|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
11073121|NCT01431287|OG004|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
11073122|NCT01431287|EG000|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073123|NCT01431287|EG001|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073124|NCT01431287|EG002|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073125|NCT01431287|EG003|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073126|NCT01431287|EG004|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11073127|NCT01431300|BG000|Baseline|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
11073128|NCT01431300|BG001|Baseline|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
11073129|NCT01431300|BG002|Baseline|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
11073130|NCT01431300|BG003|Baseline|Total|Total of all reporting groups
11073131|NCT01431300|FG000|Participant Flow|0.01 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
11073132|NCT01431300|FG001|Participant Flow|0.02 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
11073133|NCT01431300|FG002|Participant Flow|0.03 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition. This is the FDA-approved dose for lower extremity arterial imaging
11073134|NCT01431300|OG000|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
11073135|NCT01431300|OG001|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
11073136|NCT01431300|OG002|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
11073137|NCT01431300|EG000|Reported Event|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
11073138|NCT01431300|EG001|Reported Event|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
11073139|NCT01431300|EG002|Reported Event|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
11073140|NCT01431313|BG000|Baseline|WHO Group I PAH|"Idiopathic, primary or familial pulmonary arterial hypertension PAH associated with one of the following connective tissue diseases: PAH associated with exposure to drugs and toxins eg, anorexigens, L-tryptophan, toxic rapeseed oil. Stable PAH for at least 3 months if on therapy. Additionally, the mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073141|NCT01431313|BG001|Baseline|WHO Group II PH|"MPAP ≥ 25 mm Hg, PWCP > 15, and Transpulmonary Gradient (TPG) > 12. Additionally, LVEF ≥ 40% and dyspnea resulting at least a mild limitation to physical activity (functional class II or greater).~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073142|NCT01431313|BG002|Baseline|WHO Group III PH|"MPAP ≥ 25 mm Hg, PCWP ≤ 15 mm Hg, and PVR ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073143|NCT01431313|BG003|Baseline|Total|Total of all reporting groups
11073144|NCT01431313|FG000|Participant Flow|WHO Group I PAH|"Idiopathic, primary or familial pulmonary arterial hypertension PAH associated with one of the following connective tissue diseases: PAH associated with exposure to drugs and toxins eg, anorexigens, L-tryptophan, toxic rapeseed oil. Stable PAH for at least 3 months if on therapy. Additionally, the mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073145|NCT01431313|FG001|Participant Flow|WHO Group II Pulmonary Hypertension (PH)|"MPAP ≥ 25 mm Hg, PWCP > 15, and Transpulmonary Gradient (TPG) > 12. Additionally, LVEF ≥ 40% and dyspnea resulting at least a mild limitation to physical activity (functional class II or greater).~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073146|NCT01431313|FG002|Participant Flow|WHO Group III PH|"MPAP ≥ 25 mm Hg, PCWP ≤ 15 mm Hg, and PVR ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073147|NCT01431313|OG000|Outcome|WHO Group I Pulmonary Arterial Hypertension (PAH)|"Idiopathic, primary or familial pulmonary arterial hypertension (PAH) associated with one of the following connective tissue diseases: PAH associated with exposure to drugs and toxins eg, anorexigens, L-tryptophan, toxic rapeseed oil. Stable PAH for at least 3 months if on therapy. Additionally, the mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073148|NCT01431313|OG001|Outcome|WHO Group II Pulmonary Hypertension (PH)|"mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) > 15, and Transpulmonary Gradient (TPG) > 12. Additionally, left ventricular ejection fraction (LVEF) ≥ 40% and dyspnea resulting at least a mild limitation to physical activity (functional class II or greater).~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073149|NCT01431313|OG002|Outcome|WHO Group III Pulmonary Hypertension (PH)|"mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073150|NCT01431313|OG000|Outcome|WHO Group I Pulmonary Arterial Hypertension (PAH)|"Idiopathic, primary or familial pulmonary arterial hypertension PAH associated with one of the following connective tissue diseases: PAH associated with exposure to drugs and toxins eg, anorexigens, L-tryptophan, toxic rapeseed oil. Stable PAH for at least 3 months if on therapy. Additionally, the mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073151|NCT01431313|EG000|Reported Event|WHO Group I Pulmonary Arterial Hypertension (PAH)|"Idiopathic, primary or familial pulmonary arterial hypertension PAH associated with one of the following connective tissue diseases: PAH associated with exposure to drugs and toxins eg, anorexigens, L-tryptophan, toxic rapeseed oil. Stable PAH for at least 3 months if on therapy. Additionally, the mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073152|NCT01431313|EG001|Reported Event|WHO Group II Pulmonary Hypertension (PH)|"mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) > 15, and Transpulmonary Gradient (TPG) > 12. Additionally, left ventricular ejection fraction (LVEF) ≥ 40% and dyspnea resulting at least a mild limitation to physical activity (functional class II or greater).~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073153|NCT01431313|EG002|Reported Event|WHO Group III Pulmonary Hypertension (PH)|"mean pulmonary artery pressure (MPAP) ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Woods units.~Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability."
11073154|NCT01431339|BG000|Baseline|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
11073155|NCT01431339|BG001|Baseline|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
11073156|NCT01431339|BG002|Baseline|Total|Total of all reporting groups
11073157|NCT01431339|FG000|Participant Flow|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
11073158|NCT01431339|FG001|Participant Flow|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
11073159|NCT01431339|OG000|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
11073160|NCT01431339|OG001|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
11073161|NCT01431339|EG000|Reported Event|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
11073162|NCT01431339|EG001|Reported Event|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
11073163|NCT01431391|BG000|Baseline|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
11073164|NCT01431391|BG001|Baseline|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
11073165|NCT01431391|BG002|Baseline|Total|Total of all reporting groups
11073166|NCT01431391|FG000|Participant Flow|Arm 1:Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
11073167|NCT01431391|FG001|Participant Flow|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
11073168|NCT01431391|OG000|Outcome|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
11073169|NCT01431391|OG001|Outcome|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
11073170|NCT01431391|OG000|Outcome|Arm 1:Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
11073171|NCT01431391|EG000|Reported Event|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
11073172|NCT01431391|EG001|Reported Event|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
11073173|NCT01431521|BG000|Baseline|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
11073174|NCT01431521|BG001|Baseline|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
11073175|NCT01431521|BG002|Baseline|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
11073176|NCT01431521|BG003|Baseline|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
11073177|NCT01431521|BG004|Baseline|Total|Total of all reporting groups
11073178|NCT01431521|FG000|Participant Flow|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
11073179|NCT01431521|FG001|Participant Flow|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
11073180|NCT01431521|FG002|Participant Flow|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
11073181|NCT01431521|FG003|Participant Flow|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
11073182|NCT01431521|OG000|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
11073183|NCT01431521|OG001|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
11233723|NCT02430870|FG004|Participant Flow|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11073184|NCT01431521|OG002|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
11073185|NCT01431521|EG000|Reported Event|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
11073186|NCT01431521|EG001|Reported Event|Placebo for MK-4074|Participants will receive oral doses of placebo matching MK-4074 twice daily for 4 weeks.
11073187|NCT01431521|EG002|Reported Event|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg once daily for 4 weeks.
11073188|NCT01431521|EG003|Reported Event|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
11073189|NCT01431534|BG000|Baseline|Ridaforolimus 22 mg/m^2|Participants received 22 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073190|NCT01431534|BG001|Baseline|Ridaforolimus 28 mg/m^2|Participants received 28 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073191|NCT01431534|BG002|Baseline|Ridaforolimus 33 mg/m^2|Participants received 33 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073192|NCT01431534|BG003|Baseline|Total|Total of all reporting groups
11073193|NCT01431534|FG000|Participant Flow|Ridaforolimus 22 mg/m^2|Participants received 22 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073194|NCT01431534|FG001|Participant Flow|Ridaforolimus 28 mg/m^2|Participants received 28 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073195|NCT01431534|FG002|Participant Flow|Ridaforolimus 33 mg/m^2|Participants received 33 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073196|NCT01431534|OG000|Outcome|Ridaforolimus 22 mg/m^2|Participants received 22 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073197|NCT01431534|OG001|Outcome|Ridaforolimus 28 mg/m^2|Participants received 28 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073198|NCT01431534|OG002|Outcome|Ridaforolimus 33 mg/m^2|Participants received 33 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073199|NCT01431534|EG000|Reported Event|Ridaforolimus 22 mg/m^2|Participants received 22 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073200|NCT01431534|EG001|Reported Event|Ridaforolimus 28 mg/m^2|Participants received 28 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073201|NCT01431534|EG002|Reported Event|Ridaforolimus 33 mg/m^2|Participants received 33 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study.
11073202|NCT01431573|BG000|Baseline|Wake Therapy + Light Box +/- Lithium|"Bipolar patients must take lithium; others do not take lithium~all patients are hospitalized for a week during which they do not sleep on alternating nights~for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations~Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.~light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire~Lithium: For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)"
11073203|NCT01431573|FG000|Participant Flow|Wake Therapy + Light Box +/- Lithium|"Bipolar patients must take lithium; others do not take lithium~all patients are hospitalized for a week during which they do not sleep on alternating nights~for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations~Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.~light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire~Lithium: For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)"
11073204|NCT01431573|OG000|Outcome|Wake Therapy + Light Box +/- Lithium|"Bipolar patients must take lithium; others do not take lithium~all patients are hospitalized for a week during which they do not sleep on alternating nights~for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations~Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.~light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire~Lithium: For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)"
11073205|NCT01431573|EG000|Reported Event|Wake Therapy + Light Box +/- Lithium|"Bipolar patients must take lithium; others do not take lithium~all patients are hospitalized for a week during which they do not sleep on alternating nights~for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations~Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.~light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire~Lithium: For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)"
11073206|NCT01431638|BG000|Baseline|Canakinumab, Pre-filled Syringes (PFS)|Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
11073207|NCT01431638|BG001|Baseline|Canakinumab, Lyophilizate (LYO)|Participants received 150 mg S.C at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application.
11073208|NCT01431638|BG002|Baseline|Triamcinolone Acetonide|Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
11073209|NCT01431638|BG003|Baseline|Total|Total of all reporting groups
11073210|NCT01431638|FG000|Participant Flow|Canakinumab, Pre-filled Syringes (PFS)|Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
11073211|NCT01431638|FG001|Participant Flow|Canakinumab, Lyophilizate (LYO)|Participants received 150 mg S.C at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application.
11073212|NCT01431638|FG002|Participant Flow|Triamcinolone Acetonide|Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
11073213|NCT01431638|OG000|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
11073214|NCT01431638|OG001|Outcome|Canakinumab, Lyophilizate (LYO)|Participants received 150 mg S.C at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application.
11073215|NCT01431638|OG002|Outcome|Triamcinolone Acetonide|Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
11073216|NCT01431638|EG000|Reported Event|Canakinumab, Pre-filled Syringes (PFS)|Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
11073217|NCT01431638|EG001|Reported Event|Canakinumab, Lyophilizate (LYO)|Participants received 150 mg S.C at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application.
11073218|NCT01431638|EG002|Reported Event|Triamcinolone Acetonide|Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
11073219|NCT01431703|BG000|Baseline|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
11073220|NCT01431703|FG000|Participant Flow|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
11073221|NCT01431703|OG000|Outcome|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
11073222|NCT01431703|EG000|Reported Event|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
11073223|NCT01431716|BG000|Baseline|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
11073224|NCT01431716|FG000|Participant Flow|Epoprostenol for Injection (EFI/ACT-385781A)|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
11073225|NCT01431716|OG000|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
11073226|NCT01431716|EG000|Reported Event|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
11073227|NCT01431755|BG000|Baseline|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended
11073228|NCT01431755|FG000|Participant Flow|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
11073229|NCT01431755|OG000|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
11073230|NCT01431755|EG000|Reported Event|Restylane SubQ/Restylane SubQ Lidocaine: Systemic|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time.
11073231|NCT01431755|EG001|Reported Event|Restylane SubQ: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
11073232|NCT01431755|EG002|Reported Event|Restylane SubQ Lidocaine: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
11073233|NCT01431794|BG000|Baseline|Phase I, Gem, Nab-paclitaxel, and LDE225-600mg|"Phase I:~Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 600 mg daily"
11073234|NCT01431794|BG001|Baseline|Phase I, Gem, Nab-paclitaxel, and LDE225-400mg|"Phase I:~Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 400 mg daily"
11073235|NCT01431794|BG002|Baseline|Phase I, Gem, Nab-paclitaxel, and LDE225-800mg|"Phase I:~Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 800 mg daily"
11073236|NCT01431794|BG003|Baseline|Phase II, Arm A: Gem, Nab-paclitaxel, and LDE 225|"Phase II:~Arm A: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose from Phase I. Cycles repeated every 28 days."
11073237|NCT01431794|BG004|Baseline|Phase II, Arm B: Gemcitabine and Nab-paclitaxel|"Phase II:~Arm B: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days."
11073238|NCT01431794|BG005|Baseline|Total|Total of all reporting groups
11073239|NCT01431794|FG000|Participant Flow|Phase I: Gem, Nab-paclitaxel, and LDE225-600mg|Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.
11073240|NCT01431794|FG001|Participant Flow|Phase I: Gem, Nab-paclitaxel, and LDE225-400mg|Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.
11073241|NCT01431794|FG002|Participant Flow|Phase I: Gem, Nab-paclitaxel, and LDE225-800mg|Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.
11073242|NCT01431794|FG003|Participant Flow|Phase II: Arm A - Gem, Nab-paclitaxel, and LDE 225|Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days.
11073243|NCT01431794|FG004|Participant Flow|Phase II: Arm B - Gemcitabine and Nab-paclitaxel|Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.
11073244|NCT01431794|OG000|Outcome|Phase I: Gem, Nab-paclitaxel, and LDE225-600mg|Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.
11073245|NCT01431794|OG001|Outcome|Phase I: Gem, Nab-paclitaxel, and LDE225-400mg|Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.
11073246|NCT01431794|OG002|Outcome|Phase I: Gem, Nab-paclitaxel, and LDE225-800mg|Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.
11073247|NCT01431794|OG000|Outcome|Phase II-Arm A:Gem,Nab-paclitaxel,LDE225|"Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days.~LDE225-600mg: Phase I: oral LDE225 (Sonidegib), 600mg daily.~Phase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days.~Gemcitabine: Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.~nab-paclitaxel: Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.~LDE225-400mg: Phase I: oral LDE225 (Sonidegib), 400mg daily.~LDE225-800mg: Phase I: oral LDE225 (Sonidegib), 800mg daily."
11073248|NCT01431794|OG001|Outcome|Phase II-Arm B:Gem,Nab-paclitaxel|"Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.~Gemcitabine: Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.~nab-paclitaxel: Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days."
11073249|NCT01431794|EG000|Reported Event|Phase I, Gem, Nab-paclitaxel, and LDE225-600mg|Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle with oral LDE225, 600mg.
11073250|NCT01431794|EG001|Reported Event|Phase I, Gem, Nab-paclitaxel, and LDE225-400mg|Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle with oral LDE225, 400mg.
11073251|NCT01431794|EG002|Reported Event|Phase I, Gem, Nab-paclitaxel, and LDE225-800mg|Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2o n days 1, 8, and 15 every 28 days cycle with oral LDE225, 800mg.
11073252|NCT01431794|EG003|Reported Event|Phase II, Arm A: Gem, Nab-paclitaxel, and LDE 225|"Phase II:~Arm A: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase I dose. Cycles repeated every 28 days."
11073253|NCT01431794|EG004|Reported Event|Phase II, Arm B: Gemcitabine and Nab-paclitaxel|"Phase II:~Arm B: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days."
11150238|NCT01876485|EG001|Reported Event|Arm 2: Enhanced Usual Care (EUC)|"The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.~Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility."
11150239|NCT01876511|BG000|Baseline|Cohort A: MSI Positive Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11073254|NCT01431846|BG000|Baseline|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
11073255|NCT01431846|BG001|Baseline|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
11073256|NCT01431846|BG002|Baseline|Arm 3|"Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention~Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical att"
11073257|NCT01431846|BG003|Baseline|Total|Total of all reporting groups
11073258|NCT01431846|FG000|Participant Flow|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
11073259|NCT01431846|FG001|Participant Flow|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
11073260|NCT01431846|FG002|Participant Flow|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
11073261|NCT01431846|OG000|Outcome|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
11073262|NCT01431846|OG001|Outcome|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
11073263|NCT01431846|OG002|Outcome|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2)medications reconciled between pre and post-hospital discharge; 3)discharge summary available to PCP at time of visit; and 4)patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
11073264|NCT01431846|EG000|Reported Event|Discharged Patients|Total number at risk was 8. Zero adverse events were seen.
11073265|NCT01431846|EG001|Reported Event|Providers|Total number at risk was 3. Zero adverse events were seen.
11073266|NCT01431846|EG002|Reported Event|Intervention|Total number at risk was 8. Zero adverse events were seen.
11073267|NCT01431950|BG000|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073268|NCT01431950|BG001|Baseline|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073269|NCT01431950|BG002|Baseline|Total|Total of all reporting groups
11073270|NCT01431950|FG000|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073271|NCT01431950|FG001|Participant Flow|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073272|NCT01431950|OG000|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073273|NCT01431950|OG001|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073274|NCT01431950|EG000|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073275|NCT01431950|EG001|Reported Event|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073276|NCT01431963|BG000|Baseline|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
11073277|NCT01431963|FG000|Participant Flow|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
11073278|NCT01431963|OG000|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
11073279|NCT01431963|EG000|Reported Event|Lamotrigine|In the EP, lamotrigine 25 mg/day was orally administered QD; in the evening(PM) as the initial dose from W1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD(in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, Lamotrigine 200 mg/day was orally administered QD(PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at greater than or equal to 1 week intervals. A dose greater than 200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose less than 100 or greater than 400 mg/day was judged to be necessary, the participant was withdrawn from the study.
11073280|NCT01431976|BG000|Baseline|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
11150240|NCT01876511|BG001|Baseline|Cohort B: MSI Negative Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11150241|NCT01876511|BG002|Baseline|Cohort C: MSI Positive Non-Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11150242|NCT01876511|BG003|Baseline|Total|Total of all reporting groups
11150243|NCT01876511|FG000|Participant Flow|Cohort A: MSI Positive Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11150244|NCT01876511|FG001|Participant Flow|Cohort B: MSI Negative Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11150245|NCT01876511|FG002|Participant Flow|Cohort C: MSI Positive Non-Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11150246|NCT01876511|OG000|Outcome|Cohort A: MSI Positive Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11150247|NCT01876511|OG001|Outcome|Cohort B: MSI Negative Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11073281|NCT01431976|FG000|Participant Flow|Lamotrigine|In the EP, lamotrigine 0.3 milligrams per kilogram per day (mg/kg/day) was administered orally once daily from Week W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, whichever was less (WWL), until a seizure-free (SF) status was confirmed by hyperventilation (HV)-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
11073282|NCT01431976|OG000|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
11073283|NCT01431976|EG000|Reported Event|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at &gt;=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose &lt;1.2 mg/kg/day or &gt;10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
11073284|NCT01431989|BG000|Baseline|Participants Receiving Both Test and Reference Products|Participants receiving either test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2 or reference product in Period 1 and test product inPeriod 2
11073285|NCT01431989|FG000|Participant Flow|Test Product in Period 1: Reference Product in Period 2|Test product, Amoxicillin (Clamoxyl) 500 milligrams (mg)/5 milliliter (mL) powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2
11073286|NCT01431989|FG001|Participant Flow|Reference Product in Period 1: Test Product in Period 2|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 2
11073287|NCT01431989|OG000|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
11073288|NCT01431989|OG001|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
11073289|NCT01431989|EG000|Reported Event|Test Product in Period 1 and Reference Product in Period 2|Test product: Amoxicillin powder for oral suspension (Clamoxyl) 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product; Amoxil 50 mg/5 mL in Period 2
11073290|NCT01431989|EG001|Reported Event|Reference Product in Period 1 and Test Product in Period 2|Reference product: Amoxil 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product: Clamoxyl 500 mg/5 mL in Period 2
11073291|NCT01432015|BG000|Baseline|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
11073292|NCT01432015|BG001|Baseline|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
11073293|NCT01432015|BG002|Baseline|Total|Total of all reporting groups
11073294|NCT01432015|FG000|Participant Flow|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3. Patient will receive standard pre-medications on day 1
11073295|NCT01432015|FG001|Participant Flow|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
11150248|NCT01876511|OG000|Outcome|Cohort C: MSI Positive Non-Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11150249|NCT01876511|OG001|Outcome|Cohort C: MSI Positive Non-Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11073296|NCT01432015|OG000|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
11073297|NCT01432015|OG001|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
11073298|NCT01432015|EG000|Reported Event|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1
11073299|NCT01432015|EG001|Reported Event|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
11073300|NCT01432145|BG000|Baseline|6MP/MTX|"6-Mercaptopurine: The dose of 6MP will be 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. Tablets should be taken at roughly the same time each day. One cycle is 28 days. Treatment is given continuously until disease progression.~Methotrexate: Methotrexate (20 mg/m2) will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.~Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.~The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week."
11073301|NCT01432145|FG000|Participant Flow|6MP/MTX|"6-Mercaptopurine: The dose of 6MP will be 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. Tablets should be taken at roughly the same time each day. One cycle is 28 days. Treatment is given continuously until disease progression.~Methotrexate: Methotrexate (20 mg/m2) will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.~Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.~The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week."
11073302|NCT01432145|OG000|Outcome|6-Mercaptopurine and Methotrexate (6MP/MTX)|"6-Mercaptopurine: 6MP 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression.~Methotrexate: Methotrexate 20mg/m2 will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.~Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.~The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week."
11073303|NCT01432145|EG000|Reported Event|6MP/MTX|"6-Mercaptopurine: The dose of 6MP will be 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. Tablets should be taken at roughly the same time each day. One cycle is 28 days. Treatment is given continuously (see table below) until disease progression.~Methotrexate: Methotrexate (20 mg/m2) will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously (see table below) until disease progression."
11073304|NCT01432171|BG000|Baseline|Lacosamide|Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks
11073305|NCT01432171|BG001|Baseline|Placebo|Placebo orally twice a day.
11073306|NCT01432171|BG002|Baseline|Total|Total of all reporting groups
11073307|NCT01432171|FG000|Participant Flow|Lacosamide (Vimpat)|Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks
11073308|NCT01432171|FG001|Participant Flow|Placebo|Placebo orally twice a day.
11073309|NCT01432171|OG000|Outcome|Lacosamide|Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks
11073310|NCT01432171|OG001|Outcome|Placebo|Placebo orally twice a day.
11073311|NCT01432171|EG000|Reported Event|Lacosamide|Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks
11073312|NCT01432171|EG001|Reported Event|Placebo|Placebo orally twice a day.
11073313|NCT01432236|BG000|Baseline|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073314|NCT01432236|BG001|Baseline|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073315|NCT01432236|BG002|Baseline|Total|Total of all reporting groups
11073316|NCT01432236|FG000|Participant Flow|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073317|NCT01432236|FG001|Participant Flow|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073318|NCT01432236|OG000|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073319|NCT01432236|OG001|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
11073320|NCT01432236|OG000|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073321|NCT01432236|OG001|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process in period 2. There was a 2-week single-blind taper/washout period between treatment periods
11073322|NCT01432236|OG000|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073323|NCT01432236|OG001|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
11073324|NCT01432236|OG001|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073325|NCT01432236|OG001|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073326|NCT01432236|OG000|Outcome|All Participants|All randomized participants were included in this analysis.
11073327|NCT01432236|EG000|Reported Event|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
11073328|NCT01432236|EG001|Reported Event|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
11073329|NCT01432262|BG000|Baseline|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
11073330|NCT01432262|BG001|Baseline|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
11073331|NCT01432262|BG002|Baseline|Total|Total of all reporting groups
11073332|NCT01432262|FG000|Participant Flow|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
11073333|NCT01432262|FG001|Participant Flow|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
11073334|NCT01432262|OG000|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
11073335|NCT01432262|OG001|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
11073336|NCT01432262|EG000|Reported Event|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
11073337|NCT01432262|EG001|Reported Event|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
11073338|NCT01432275|BG000|Baseline|Per Protocol Population|Subjects who completed the study.
11073339|NCT01432275|FG000|Participant Flow|ADC, Then Comparator, Then ADC With Calculator|Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
11073340|NCT01432275|FG001|Participant Flow|Comparator, Then ADC, Then ADC With Calculator|Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
11073341|NCT01432275|OG000|Outcome|Per Protocol Population|Subjects completing the study using the FreeStyle InsuLinx Blood Glucose Meter and one of the comparator blood glucose meters
11073342|NCT01432275|EG000|Reported Event|ADC Blood Glucose Meter|ADC blood glucose meter for 7 days with the insulin calculator not activated.
11073343|NCT01432275|EG001|Reported Event|Comparator Blood Glucose Meter|Comparator blood glucose meter for 7 days.
11073344|NCT01432275|EG002|Reported Event|ADC Blood Glucose Meter With Calculator|ADC blood glucose meter for 10 days with the insulin calculator active.
11073345|NCT01432327|BG000|Baseline|Control Group|This group receives no kind of feedback during the intervention period
11073346|NCT01432327|BG001|Baseline|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
10887648|NCT00501995|FG000|Participant Flow|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
11073347|NCT01432327|BG002|Baseline|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
11073348|NCT01432327|BG003|Baseline|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
11073349|NCT01432327|BG004|Baseline|Total|Total of all reporting groups
11073350|NCT01432327|FG000|Participant Flow|Control Group|This group receives no kind of feedback during the intervention period
11073351|NCT01432327|FG001|Participant Flow|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
11073352|NCT01432327|FG002|Participant Flow|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
11073353|NCT01432327|FG003|Participant Flow|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
11073354|NCT01432327|OG000|Outcome|Control Group|This group receives no kind of feedback during the intervention period
11073355|NCT01432327|OG001|Outcome|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
11073356|NCT01432327|OG002|Outcome|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
11073357|NCT01432327|OG003|Outcome|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
11073358|NCT01432327|EG000|Reported Event|Control Group|This group receives no kind of feedback during the intervention period
11073359|NCT01432327|EG001|Reported Event|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
11073360|NCT01432327|EG002|Reported Event|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
11073361|NCT01432327|EG003|Reported Event|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
11073362|NCT01432366|BG000|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
11073363|NCT01432366|FG000|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
11073364|NCT01432366|OG000|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
11073365|NCT01432366|EG000|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
11073366|NCT01432379|BG000|Baseline|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
11073367|NCT01432379|FG000|Participant Flow|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
11073368|NCT01432379|OG000|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
11073369|NCT01432379|EG000|Reported Event|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
11091854|NCT01536496|FG000|Participant Flow|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
11091855|NCT01536496|FG001|Participant Flow|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
11091856|NCT01536496|OG000|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
11091857|NCT01536496|OG001|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
11091858|NCT01536496|OG000|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
11091859|NCT01536496|OG000|Outcome|Control (INR, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
11150250|NCT01876511|OG002|Outcome|Cohort C: MSI Positive Non-Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11073370|NCT01432405|BG000|Baseline|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
11073371|NCT01432405|BG001|Baseline|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
11073372|NCT01432405|BG002|Baseline|Total|Total of all reporting groups
11073373|NCT01432405|FG000|Participant Flow|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
11073374|NCT01432405|FG001|Participant Flow|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
11073375|NCT01432405|OG000|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
11073376|NCT01432405|OG001|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
11073377|NCT01432405|EG000|Reported Event|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
11073378|NCT01432405|EG001|Reported Event|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
11073379|NCT01432444|BG000|Baseline|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
11150251|NCT01876511|EG000|Reported Event|Cohort A: MSI Positive Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11073380|NCT01432444|FG000|Participant Flow|Tolerability/Cross-titration Phase (Phase A)|In Phase A, participants who had no history of tolerating oral aripiprazole entered a Tolerability Assessment/Cross-titration Phase in order to assess tolerability to oral aripiprazole. The recommended initial dose of oral aripiprazole in the Tolerability Assessment/Cross-titration Phase was 10 mg or 15 mg/day, depending on the participant's symptoms and the study physician's judgment. Participants were seen in the clinic at baseline and weekly thereafter for a minimum of 1 week and maximum of 4 weeks/28 days, until tolerability to oral aripiprazole had been determined, based on physician's discretion, or until the participant was terminated from the study.
11073381|NCT01432444|FG001|Participant Flow|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
11073382|NCT01432444|FG002|Participant Flow|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believes would receive benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
11073383|NCT01432444|OG000|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
11073384|NCT01432444|EG000|Reported Event|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
11073385|NCT01432444|EG001|Reported Event|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believed would benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
11073386|NCT01432457|BG000|Baseline|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
11073387|NCT01432457|BG001|Baseline|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
11073388|NCT01432457|BG002|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
11073389|NCT01432457|BG003|Baseline|Total|Total of all reporting groups
11073390|NCT01432457|FG000|Participant Flow|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
11073391|NCT01432457|FG001|Participant Flow|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
11073392|NCT01432457|FG002|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
11073393|NCT01432457|OG000|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
11073394|NCT01432457|OG001|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
11073395|NCT01432457|OG002|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
11073396|NCT01432457|EG000|Reported Event|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
11073397|NCT01432457|EG001|Reported Event|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
11073398|NCT01432457|EG002|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
11150252|NCT01876511|EG001|Reported Event|Cohort B: MSI Negative Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11073399|NCT01432535|BG000|Baseline|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073400|NCT01432535|BG001|Baseline|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073401|NCT01432535|BG002|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073402|NCT01432535|BG003|Baseline|Total|Total of all reporting groups
11073403|NCT01432535|FG000|Participant Flow|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073404|NCT01432535|FG001|Participant Flow|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073405|NCT01432535|FG002|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073406|NCT01432535|OG000|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073407|NCT01432535|OG001|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073408|NCT01432535|OG002|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073409|NCT01432535|EG000|Reported Event|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073410|NCT01432535|EG001|Reported Event|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073411|NCT01432535|EG002|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
11073412|NCT01432561|BG000|Baseline|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
11073413|NCT01432561|FG000|Participant Flow|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
11073414|NCT01432561|OG000|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
11073415|NCT01432561|EG000|Reported Event|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
11073416|NCT01432574|BG000|Baseline|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
11073417|NCT01432574|FG000|Participant Flow|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
11073418|NCT01432574|OG000|Outcome|Gardasil Vaccine - Month 7|
11073419|NCT01432574|OG000|Outcome|Gardasil Vaccine - Day 1|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
11073420|NCT01432574|OG001|Outcome|Gardasil Vaccine - Month 7|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
11073421|NCT01432574|EG000|Reported Event|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
11073422|NCT01432600|BG000|Baseline|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
11073423|NCT01432600|BG001|Baseline|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
11073424|NCT01432600|BG002|Baseline|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
11073425|NCT01432600|BG003|Baseline|Total|Total of all reporting groups
11073426|NCT01432600|FG000|Participant Flow|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
11150253|NCT01876511|EG002|Reported Event|Cohort C: MSI Positive Non-Colorectal Cancer|MK-3475: MK-3475 10 mg/kg every 14 days
11073427|NCT01432600|FG001|Participant Flow|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Arm D participants may be referenced separately in some Outcome Measures."
11073428|NCT01432600|FG002|Participant Flow|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
11073429|NCT01432600|OG000|Outcome|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
11073430|NCT01432600|OG000|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
11073431|NCT01432600|OG001|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
11073432|NCT01432600|OG002|Outcome|D: Crossover Arm|Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
11073433|NCT01432600|EG000|Reported Event|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
11073434|NCT01432600|EG001|Reported Event|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
11073435|NCT01432600|EG002|Reported Event|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
11073436|NCT01432600|EG003|Reported Event|D: Crossover Arm|Phase II: Participants who crossed over from Arm B to Arm D.
11073437|NCT01432626|BG000|Baseline|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
11073438|NCT01432626|FG000|Participant Flow|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
11073439|NCT01432626|OG000|Outcome|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
11073440|NCT01432626|EG000|Reported Event|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
11073441|NCT01432730|BG000|Baseline|All Participants|Gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks in Period 2 OR Placebo to gefapixant, BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 2
11073442|NCT01432730|FG000|Participant Flow|Gefapixant 600 mg>Placebo|Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then placebo, BID, taken orally for 2 weeks in Period 2
11073443|NCT01432730|FG001|Participant Flow|Placebo>Gefapixant 600mg|Placebo BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 2
11073444|NCT01432730|OG000|Outcome|Gefapixant 600 mg|Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks
11073445|NCT01432730|OG001|Outcome|Placebo|Placebo BID taken orally for 2 weeks
11073446|NCT01432730|EG000|Reported Event|Gefapixant 600 mg|Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks
11073447|NCT01432730|EG001|Reported Event|Placebo|Placebo BID taken orally for 2 weeks
11073448|NCT01432756|BG000|Baseline|Wait-list Control - Parent Participants|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
11073449|NCT01432756|BG001|Baseline|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
11073450|NCT01432756|BG002|Baseline|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
11073451|NCT01432756|BG003|Baseline|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
11073452|NCT01432756|BG004|Baseline|Total|Total of all reporting groups
11073453|NCT01432756|FG000|Participant Flow|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
11073454|NCT01432756|FG001|Participant Flow|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
11073455|NCT01432756|FG002|Participant Flow|Wait-list Control - Adolescent Partipants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
11073456|NCT01432756|FG003|Participant Flow|Let's Talk Worksite Parenting Program - Adolescent Participant|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
11073457|NCT01432756|OG000|Outcome|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
11073458|NCT01432756|OG001|Outcome|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
11073459|NCT01432756|OG002|Outcome|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
11073460|NCT01432756|OG003|Outcome|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
11073461|NCT01432756|EG000|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
11150254|NCT01876706|BG000|Baseline|UroLift Arm|Subjects that undergo the UroLift System procedure
11073462|NCT01432756|EG001|Reported Event|Let's Talk Worskite Parenting Program|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
11073463|NCT01432886|BG000|Baseline|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
11073464|NCT01432886|BG001|Baseline|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
11073465|NCT01432886|BG002|Baseline|Total|Total of all reporting groups
11073466|NCT01432886|FG000|Participant Flow|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
11073467|NCT01432886|FG001|Participant Flow|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
11073468|NCT01432886|OG000|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
11073469|NCT01432886|OG001|Outcome|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
11073470|NCT01432886|OG001|Outcome|E7389 With Triweekly Trastuzumab|"Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle.~Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses."
11073471|NCT01432886|EG000|Reported Event|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
11073472|NCT01432886|EG001|Reported Event|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
11073473|NCT01432938|BG000|Baseline|Entire Study Population|Participants who received at least one dose of study drug (dulaglutide or warfarin).
11073474|NCT01432938|FG000|Participant Flow|Warfarin First, Then Dulaglutide + Warfarin|"First Intervention: A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 (Treatment 1).~There was a washout period of at least 24 days between treatment periods.~Second Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2)."
11073475|NCT01432938|FG001|Participant Flow|Dulaglutide + Warfarin First, Then Warfarin|"First Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2).~There was a washout period of at least 24 days between intervention periods.~Second Intervention: A single, 10-mg dose of warfarin administered orally on Day 1 (Treatment 1)."
11073476|NCT01432938|OG000|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
11073477|NCT01432938|OG001|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
11073478|NCT01432938|EG000|Reported Event|Warfarin Alone|"A single, 10-milligram (mg) dose administered orally on Day 1 of Treatment 1.~Timeframe: Treatment 1"
11073479|NCT01432938|EG001|Reported Event|Dulaglutide Alone|"A single, 1.5-mg dose administered subcutaneously on Day 1 of Treatment 2.~Timeframe: Day 1 to Day 3 before dosing of warfarin in Treatment 2"
11073480|NCT01432938|EG002|Reported Event|Dulaglutide + Warfarin|"A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2~Timeframe: After dosing of warfarin on Day 3 of Treatment 2"
11073481|NCT01432951|BG000|Baseline|Enzastaurin|Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
11073482|NCT01432951|FG000|Participant Flow|Enzastaurin|"Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.~Safety Extension: Participants had the option to continue receiving enzastaurin treatment until disease progression or discontinuation criteria are met, as per the investigator's assessment."
11073483|NCT01432951|OG000|Outcome|Enzastaurin|Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
11073484|NCT01432951|EG000|Reported Event|Enzastaurin|Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
11150255|NCT01876706|FG000|Participant Flow|UroLift Arm|Subjects that undergo the UroLift System procedure
11349075|NCT04126343|OG000|Outcome|Padsevonil (PKS)|"Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period.~On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed Pharmacokinetic Set (PKS)."
11073485|NCT01432951|EG001|Reported Event|Enzastaurin Safety Extension|Participants had the option to continue receiving enzastaurin 500 mg, orally once daily until disease progression or discontinuation criteria are met, as per the investigator's assessment.
11073486|NCT01433016|BG000|Baseline|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
11073487|NCT01433016|FG000|Participant Flow|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
11073488|NCT01433016|OG000|Outcome|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
11073489|NCT01433016|EG000|Reported Event|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
11073490|NCT01433042|BG000|Baseline|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
11073491|NCT01433042|FG000|Participant Flow|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
11073492|NCT01433042|OG000|Outcome|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
11073493|NCT01433042|EG000|Reported Event|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
11073494|NCT01433055|BG000|Baseline|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
11073495|NCT01433055|BG001|Baseline|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
11073496|NCT01433055|BG002|Baseline|Total|Total of all reporting groups
11073497|NCT01433055|FG000|Participant Flow|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
11073498|NCT01433055|FG001|Participant Flow|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
11073499|NCT01433055|OG000|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
11073500|NCT01433055|OG001|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
11349076|NCT04126343|OG000|Outcome|Padsevonil (SS)|Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed Safety Set (SS).
11073501|NCT01433055|EG000|Reported Event|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
11073502|NCT01433055|EG001|Reported Event|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
11073503|NCT01433081|BG000|Baseline|Magnesium Sulfate Infusion|Administration of magnesium suflate
11073504|NCT01433081|BG001|Baseline|Placebo|.9 normal saline infusion
11073505|NCT01433081|BG002|Baseline|Total|Total of all reporting groups
11073506|NCT01433081|FG000|Participant Flow|Magnesium Sulfate Infusion|Administration of magnesium suflate
11073507|NCT01433081|FG001|Participant Flow|Placebo|Normal saline infusion
11073508|NCT01433081|OG000|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
11073509|NCT01433081|OG001|Outcome|Placebo|Normal saline infusion
11073510|NCT01433081|OG001|Outcome|Placebo|.9 normal saline infusion
11073511|NCT01433081|EG000|Reported Event|Magnesium Sulfate Infusion|Administration of magnesium suflate
11073512|NCT01433081|EG001|Reported Event|Placebo|.9 normal saline infusion
11073513|NCT01433107|BG000|Baseline|Terbinafine|Drug
11073514|NCT01433107|BG001|Baseline|Placebo|Drug
11073515|NCT01433107|BG002|Baseline|Total|Total of all reporting groups
11349077|NCT04126343|OG001|Outcome|Moxifloxacin (SS)|Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the SS.
11349078|NCT04126343|OG002|Outcome|Placebo (SS)|Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the SS.
11349079|NCT04126343|EG000|Reported Event|Padsevonil (SS)|Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed Safety Set (SS).
11073516|NCT01433107|FG000|Participant Flow|Terbinafine|Drug
11073517|NCT01433107|FG001|Participant Flow|Placebo|Drug
11073518|NCT01433107|OG000|Outcome|Terbinafine|Drug
11073519|NCT01433107|OG001|Outcome|Placebo|Drug
11073520|NCT01433107|EG000|Reported Event|Terbinafine|Drug
11073521|NCT01433107|EG001|Reported Event|Placebo|Drug
11073522|NCT01433159|BG000|Baseline|HP011-101|Xenaderm Ointment
11073523|NCT01433159|BG001|Baseline|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
11073524|NCT01433159|BG002|Baseline|Total|Total of all reporting groups
11073525|NCT01433159|FG000|Participant Flow|HP011-101|Xenaderm Ointment
11073526|NCT01433159|FG001|Participant Flow|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
11073527|NCT01433159|OG000|Outcome|HP011-101|Xenaderm Ointment
11073528|NCT01433159|OG001|Outcome|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT-containing products
11073529|NCT01433159|EG000|Reported Event|HP011-101|Xenaderm Ointment
11073530|NCT01433159|EG001|Reported Event|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
11073531|NCT01433172|BG000|Baseline|Phase I Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
11073532|NCT01433172|BG001|Baseline|Phase II Arm A Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
11073533|NCT01433172|BG002|Baseline|Phase II Arm B Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
11073534|NCT01433172|BG003|Baseline|Total|Total of all reporting groups
11073535|NCT01433172|FG000|Participant Flow|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period.
11073536|NCT01433172|FG001|Participant Flow|Phase II Arm A GM.CD40L Cells Vaccinations|Phase II Arm A: Participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
11073537|NCT01433172|FG002|Participant Flow|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Phase II Arm B: Participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
11073538|NCT01433172|OG000|Outcome|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
11073539|NCT01433172|OG000|Outcome|Phase II Arm A GM.CD40L Cells Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
11073540|NCT01433172|OG001|Outcome|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
11073541|NCT01433172|EG000|Reported Event|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
11073542|NCT01433172|EG001|Reported Event|Phase II Arm A GM.CD40L Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
11073543|NCT01433172|EG002|Reported Event|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
11073544|NCT01433250|BG000|Baseline|AIN457/ AIN457|AIN in core study , continued AIN in extension study
11073545|NCT01433250|BG001|Baseline|Placebo/AIN457|Placebo for core study and AIN in extension study
11073546|NCT01433250|BG002|Baseline|Total|Total of all reporting groups
11073547|NCT01433250|FG000|Participant Flow|AIN457 Core / AIN457 Extension|AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks)
11073548|NCT01433250|FG001|Participant Flow|AIN Placebo/ AIN457 Extension|"Placebo in core study and AIN in extension study~(10 mg/kg iv every four weeks)"
11233724|NCT02430870|FG005|Participant Flow|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11073549|NCT01433250|OG000|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
11073550|NCT01433250|OG001|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
11073551|NCT01433250|EG000|Reported Event|Placebo(Core)/AIN457(Extension)|Placebo(core)/AIN457(extension)
11073552|NCT01433250|EG001|Reported Event|AIN457(Core)/AIN457(Extension)|AIN457(core)/AIN457(extension)
11233725|NCT02430870|FG006|Participant Flow|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11073553|NCT01433263|BG000|Baseline|30mg/kg BYM338|
11073554|NCT01433263|BG001|Baseline|Placebo / Late 30mg/kg BYM338|
11073555|NCT01433263|BG002|Baseline|Total|Total of all reporting groups
11073556|NCT01433263|FG000|Participant Flow|30mg/kg BYM338|
11073557|NCT01433263|FG001|Participant Flow|Placebo / Late 30mg/kg BYM338|
11073558|NCT01433263|OG000|Outcome|30mg/kg BYM338|
11073559|NCT01433263|OG001|Outcome|Placebo / Late 30mg/kg BYM338|
11073560|NCT01433263|EG000|Reported Event|Core - 30mg/kg BYM338|Core - 30mg/kg BYM338
11073561|NCT01433263|EG001|Reported Event|Core - Placebo|Core - Placebo
11073562|NCT01433263|EG002|Reported Event|Follow-up - 30mg/kg BYM338|Follow-up - 30mg/kg BYM338
11073563|NCT01433263|EG003|Reported Event|Follow-up - Placebo|Follow-up - Placebo
11073564|NCT01433263|EG004|Reported Event|Follow-up - 30mg/kg BYM338 Late|Follow-up - 30mg/kg BYM338 Late
11073565|NCT01433354|BG000|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
11073566|NCT01433354|FG000|Participant Flow|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
11073567|NCT01433354|OG000|Outcome|AFQ056|Total
11073568|NCT01433354|OG001|Outcome|Prior to Ext. First Dose|
11073569|NCT01433354|OG002|Outcome|AFQ056 25 mg Bid|
11073570|NCT01433354|OG003|Outcome|AFQ056 50 mg Bid|
11073571|NCT01433354|OG004|Outcome|AFQ056 75 mg Bid|
11073572|NCT01433354|OG005|Outcome|AFQ056 100 mg Bid|
11073573|NCT01433354|EG000|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
11073574|NCT01433354|EG001|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
11073575|NCT01433354|EG002|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
11073576|NCT01433354|EG003|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
11073577|NCT01433354|EG004|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
11073578|NCT01433354|EG005|Reported Event|Total|Total
11073579|NCT01433549|BG000|Baseline|Overall|Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
11073580|NCT01433549|FG000|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
11073581|NCT01433549|FG001|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
11073582|NCT01433549|OG000|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
11073583|NCT01433549|OG001|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
11073584|NCT01433549|EG000|Reported Event|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
11073585|NCT01433549|EG001|Reported Event|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
11073586|NCT01433731|BG000|Baseline|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
11073587|NCT01433731|BG001|Baseline|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
11073588|NCT01433731|BG002|Baseline|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
11073589|NCT01433731|BG003|Baseline|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
11073590|NCT01433731|BG004|Baseline|Total|Total of all reporting groups
11073591|NCT01433731|FG000|Participant Flow|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
11073592|NCT01433731|FG001|Participant Flow|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
11073593|NCT01433731|FG002|Participant Flow|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
11073594|NCT01433731|FG003|Participant Flow|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
11073595|NCT01433731|OG000|Outcome|SHAPE (SHP-141)|"Histone deacetylase inhibitor~SHAPE (SHP-141): topical gel"
11073596|NCT01433731|OG001|Outcome|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
11073597|NCT01433731|EG000|Reported Event|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
11073598|NCT01433731|EG001|Reported Event|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
11073599|NCT01433731|EG002|Reported Event|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
11073600|NCT01433731|EG003|Reported Event|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
11073601|NCT01433913|BG000|Baseline|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg metformin tablets until the day before surgery) for 4-12 weeks.
11073602|NCT01433913|BG001|Baseline|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets until the day before surgery) for 4-12 weeks.
11073603|NCT01433913|BG002|Baseline|Total|Total of all reporting groups
11073604|NCT01433913|FG000|Participant Flow|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
11073605|NCT01433913|FG001|Participant Flow|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
11073606|NCT01433913|OG000|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg metformin tablets daily until the day before surgery) for 4-12 weeks.
11073607|NCT01433913|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
11073608|NCT01433913|OG000|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
11073609|NCT01433913|EG000|Reported Event|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
11073610|NCT01433913|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11073611|NCT01433978|BG000|Baseline|Eltrombopag (Core Study)|Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
11073612|NCT01433978|BG001|Baseline|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
11349080|NCT04126343|EG001|Reported Event|Moxifloxacin (SS)|Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the SS.
11073613|NCT01433978|BG002|Baseline|Total|Total of all reporting groups
11073614|NCT01433978|FG000|Participant Flow|Eltrombopag (Core Study)|Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
11073615|NCT01433978|FG001|Participant Flow|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
11073616|NCT01433978|FG002|Participant Flow|Avatrombopag (Open-label Extension Phase)|Participants who met the eligibility requirements for the Open-label Extension (OLE) Phase or who discontinued the Core Study early because of lack of treatment effect were eligible to continue into the OLE Phase for up to 104 weeks of open-label avatrombopag therapy. Participants entering the OLE from the Core Study received a starting dose of open-label avatrombopag that was determined by the last dose of study drug at the End of Treatment (EOT) Visit (Visit 22) of the Core Study. Participants who discontinued the Core Study early because of lack of treatment effect and entered the OLE received open-label avatrombopag at a starting dose of 20 mg once daily of open-label avatrombopag.
11073617|NCT01433978|OG000|Outcome|Eltrombopag (Core Study)|Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
11073618|NCT01433978|OG001|Outcome|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
11073619|NCT01433978|EG000|Reported Event|Eltrombopag (Core Study)|Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
11073620|NCT01433978|EG001|Reported Event|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
11073621|NCT01433978|EG002|Reported Event|Avatrombopag (Extension Phase)|Participants who met the eligibility requirements for the Open-label Extension (OLE) Phase or who discontinued the Core Study early because of lack of treatment effect were eligible to continue into the OLE Phase for up to 104 weeks of open-label avatrombopag therapy. Participants entering the OLE from the Core Study received a starting dose of open-label avatrombopag that was determined by the last dose of study drug at the End of Treatment (EOT) Visit (Visit 22) of the Core Study. Participants who discontinued the Core Study early because of lack of treatment effect and entered the OLE received open-label avatrombopag at a starting dose of 20 mg once daily of open-label avatrombopag.
11073622|NCT01433991|BG000|Baseline|Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg|Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073623|NCT01433991|BG001|Baseline|Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073624|NCT01433991|BG002|Baseline|Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 300 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 300 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073625|NCT01433991|BG003|Baseline|Cohort 4: Lenvatinib 20 mg + Golvatinib 400 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 400 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 400 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073626|NCT01433991|BG004|Baseline|Total|Total of all reporting groups
11073627|NCT01433991|FG000|Participant Flow|Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg|Participants received lenvatinib 12 milligram (mg) capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073628|NCT01433991|FG001|Participant Flow|Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11150256|NCT01876706|OG000|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
11150257|NCT01876706|EG000|Reported Event|UroLift Arm|Subjects that undergo the UroLift System procedure
11150258|NCT01876732|BG000|Baseline|Vitamin B12|Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
11173540|NCT02016183|BG000|Baseline|Candesartan Cilexetil/Hydrochlorothiazide|Candesartan cilexetil/Hydrochlorothiazide 4 mg/6.25 mg or 8 mg/6.25 mg combination tablets, orally, once daily for up to 12 months. This drug should not be used as a first-line drug for hypertension treatment. Participants received interventions as part of routine medical care.
11073629|NCT01433991|FG002|Participant Flow|Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 300 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 300 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073630|NCT01433991|FG003|Participant Flow|Cohort 4: Lenvatinib 20 mg + Golvatinib 400 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 400 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 400 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073631|NCT01433991|OG000|Outcome|Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg|Eligible participants from single agent run-in period, received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073632|NCT01433991|OG001|Outcome|Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg|Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073633|NCT01433991|OG002|Outcome|Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg|Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 300 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073634|NCT01433991|OG003|Outcome|Cohort 4: Lenvatinib 20 mg + Golvatinib 400 mg|Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 400 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073635|NCT01433991|OG000|Outcome|All Cohorts: Golvatinib + Lenvatinib|Eligible participants from single agent run-in period, received lenvatinib 12 mg or 20 mg capsules, orally, once daily in combination with golvatinib 200 mg or 300 mg or 400 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073636|NCT01433991|OG000|Outcome|All Cohorts: Lenvatinib + Golvatinib|Eligible participants from single agent run-in period, received lenvatinib 12 mg or 20 mg capsules, orally, once daily in combination with golvatinib 200 mg or 300 mg or 400 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073637|NCT01433991|OG000|Outcome|Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg|Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073638|NCT01433991|OG001|Outcome|Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073639|NCT01433991|OG002|Outcome|Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 300 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 300 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11349081|NCT04126343|EG002|Reported Event|Placebo (SS)|Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the SS.
11073640|NCT01433991|OG003|Outcome|Cohort 4: Lenvatinib 20 mg + Golvatinib 400 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 400 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 400 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11173541|NCT02016183|FG000|Participant Flow|Candesartan Cilexetil/Hydrochlorothiazide|Candesartan cilexetil/Hydrochlorothiazide 4 mg/6.25 mg or 8 mg/6.25 mg combination tablets, orally, once daily for up to 12 months. This drug should not be used as a first-line drug for hypertension treatment. Participants received interventions as part of routine medical care.
11349082|NCT04126187|BG000|Baseline|Panoptix|"Bilateral implantation of the Panoptix trifocal IOL~Panoptix: Panoptix trifocal intraocular lens (IOL)"
11073641|NCT01433991|EG000|Reported Event|Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg|Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073642|NCT01433991|EG001|Reported Event|Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073643|NCT01433991|EG002|Reported Event|Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 300 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 300 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073644|NCT01433991|EG003|Reported Event|Cohort 4: Lenvatinib 20 mg + Golvatinib 400 mg|Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 400 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 400 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks).
11073645|NCT01434030|BG000|Baseline|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm - behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients' self-treatment behavior.
11073646|NCT01434030|FG000|Participant Flow|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants' desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
11073647|NCT01434030|OG000|Outcome|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants' desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
11073648|NCT01434030|OG000|Outcome|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm - behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients' self-treatment behavior.
11173542|NCT02016183|OG000|Outcome|Candesartan Cilexetil/Hydrochlorothiazide|Candesartan cilexetil/Hydrochlorothiazide 4 mg/6.25 mg or 8 mg/6.25 mg combination tablets, orally, once daily for up to 12 months. This drug should not be used as a first-line drug for hypertension treatment. Participants received interventions as part of routine medical care.
11349083|NCT04126187|FG000|Participant Flow|Panoptix|"Bilateral implantation of the Panoptix trifocal IOL~Panoptix: Panoptix trifocal intraocular lens (IOL)"
11349084|NCT04126187|OG000|Outcome|Panoptix|"Bilateral implantation of the Panoptix trifocal IOL~Panoptix: Panoptix trifocal intraocular lens (IOL)"
11173543|NCT02016183|EG000|Reported Event|Candesartan Cilexetil/Hydrochlorothiazide|Candesartan cilexetil/Hydrochlorothiazide 4 mg/6.25 mg or 8 mg/6.25 mg combination tablets, orally, once daily for up to 12 months. This drug should not be used as a first-line drug for hypertension treatment. Participants received interventions as part of routine medical care.
11173544|NCT02016235|BG000|Baseline|Dent Disease Intervention|"Dent Disease subjects will receive 2 week supplementation with phosphorus~Phosphorus Supplement: 250 mg po qid"
11173545|NCT02016235|BG001|Baseline|Kidney Stone Subjects|"Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus~Phosphorus Supplement: 250 mg po qid"
11073649|NCT01434030|EG000|Reported Event|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm - behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients' self-treatment behavior.
11073650|NCT01434121|BG000|Baseline|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073651|NCT01434121|BG001|Baseline|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073652|NCT01434121|BG002|Baseline|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073653|NCT01434121|BG003|Baseline|Total|Total of all reporting groups
11073654|NCT01434121|FG000|Participant Flow|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073655|NCT01434121|FG001|Participant Flow|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073656|NCT01434121|FG002|Participant Flow|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073657|NCT01434121|OG000|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073658|NCT01434121|OG001|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073659|NCT01434121|OG002|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073660|NCT01434121|OG000|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073661|NCT01434121|OG001|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073662|NCT01434121|OG002|Outcome|Placebo|"Subject receives an infusion of saline~Placebo"
11073663|NCT01434121|EG000|Reported Event|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073664|NCT01434121|EG001|Reported Event|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073665|NCT01434121|EG002|Reported Event|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
11073666|NCT01434186|BG000|Baseline|Placebo|Placebo matching saxagliptin
11073667|NCT01434186|BG001|Baseline|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
11073668|NCT01434186|BG002|Baseline|Total|Total of all reporting groups
11073669|NCT01434186|FG000|Participant Flow|Placebo|Placebo matching saxagliptin
11073670|NCT01434186|FG001|Participant Flow|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
11173546|NCT02016235|BG002|Baseline|Dent Disease Observation|"Dent disease subjects will not get phosphorus~Observation: Baseline blood and urine measurements only"
11073671|NCT01434186|OG000|Outcome|Saxagliptin|Saxagliptin 2.5 mg or 5 mg according to bodyweight
11073672|NCT01434186|OG001|Outcome|Placebo|Saxagliptin matching placebo
11073673|NCT01434186|EG000|Reported Event|Placebo|Placebo matching saxagliptin
11073674|NCT01434186|EG001|Reported Event|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
11073675|NCT01434342|BG000|Baseline|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
11073676|NCT01434342|BG001|Baseline|Arm II|"Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's Clearing the Air smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy."
11073677|NCT01434342|BG002|Baseline|Total|Total of all reporting groups
11173547|NCT02016235|BG003|Baseline|Total|Total of all reporting groups
11173548|NCT02016235|FG000|Participant Flow|Dent Disease Intervention|"Dent Disease subjects will receive 2 week supplementation with phosphorus~Phosphorus Supplement: 250 mg po qid"
11173549|NCT02016235|FG001|Participant Flow|Kidney Stone Subjects|"Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus~Phosphorus Supplement: 250 mg po qid"
11073678|NCT01434342|FG000|Participant Flow|Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
11073679|NCT01434342|FG001|Participant Flow|Usual Care|"Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's Clearing the Air smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy."
11073680|NCT01434342|OG000|Outcome|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.~The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.~Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.~Participants also learn behavioral tips and coping skills."
11073681|NCT01434342|OG001|Outcome|Arm II - Usual Care|"Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's Clearing the Air smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy."
11073682|NCT01434342|EG000|Reported Event|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
11073683|NCT01434342|EG001|Reported Event|Arm II - Usual Care|"Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's Clearing the Air smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy."
11073684|NCT01434472|BG000|Baseline|Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)|"Beginning 24-48 hours prior to therapy infusion, patients receive rituximab IV over 4-6 hours and then receive a therapy-dose of high-dose yttrium Y 90 ibritumomab tiuxetan IV over 30 minutes on day -14 prior to transplant. Patients also receive fludarabine phosphate IV on days -4 to -2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine PO BID on days -3 to 56 with taper to day 180 (related donor) or -3 to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days 0-27 (related donor) or PO TID on days 0-40 with taper to day 96 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Indium In-111 Ibritumomab Tiuxetan: Given IV~Mycophenolate Mofetil: Given PO~Pharmacological Study: Correlative studies~Rituximab: Given IV prior to yttrium Y 90 ibritumomab tiuxetan~Total-Body Irradiation: Undergo TBI~Yttrium Y-90 Ibritumomab Tiuxetan: Given IV~Fludarabine: Given IV"
11073685|NCT01434472|FG000|Participant Flow|Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)|"Beginning 24-48 hours prior to therapy infusion, patients receive rituximab IV over 4-6 hours and then receive a therapy-dose of high-dose yttrium Y 90 ibritumomab tiuxetan IV over 30 minutes on day -14 prior to transplant. Patients also receive fludarabine phosphate IV on days -4 to -2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine PO BID on days -3 to 56 with taper to day 180 (related donor) or -3 to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days 0-27 (related donor) or PO TID on days 0-40 with taper to day 96 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Indium In-111 Ibritumomab Tiuxetan: Given IV~Mycophenolate Mofetil: Given PO~Pharmacological Study: Correlative studies~Rituximab: Given IV prior to yttrium Y 90 ibritumomab tiuxetan~Total-Body Irradiation: Undergo TBI~Yttrium Y-90 Ibritumomab Tiuxetan: Given IV~Fludarabine: Given IV"
11073686|NCT01434472|OG000|Outcome|Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)|"Beginning 24-48 hours prior to therapy infusion, patients receive rituximab IV over 4-6 hours and then receive a therapy-dose of high-dose yttrium Y 90 ibritumomab tiuxetan IV over 30 minutes on day -14 prior to transplant. Patients also receive fludarabine phosphate IV on days -4 to -2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine PO BID on days -3 to 56 with taper to day 180 (related donor) or -3 to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days 0-27 (related donor) or PO TID on days 0-40 with taper to day 96 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Indium In-111 Ibritumomab Tiuxetan: Given IV~Mycophenolate Mofetil: Given PO~Pharmacological Study: Correlative studies~Rituximab: Given IV prior to yttrium Y 90 ibritumomab tiuxetan~Total-Body Irradiation: Undergo TBI~Yttrium Y-90 Ibritumomab Tiuxetan: Given IV~Fludarabine: Given IV"
11073687|NCT01434472|EG000|Reported Event|Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)|"Beginning 24-48 hours prior to therapy infusion, patients receive rituximab IV over 4-6 hours and then receive a therapy-dose of high-dose yttrium Y 90 ibritumomab tiuxetan IV over 30 minutes on day -14 prior to transplant. Patients also receive fludarabine phosphate IV on days -4 to -2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine PO BID on days -3 to 56 with taper to day 180 (related donor) or -3 to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days 0-27 (related donor) or PO TID on days 0-40 with taper to day 96 (unrelated donor).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Indium In-111 Ibritumomab Tiuxetan: Given IV~Mycophenolate Mofetil: Given PO~Pharmacological Study: Correlative studies~Rituximab: Given IV prior to yttrium Y 90 ibritumomab tiuxetan~Total-Body Irradiation: Undergo TBI~Yttrium Y-90 Ibritumomab Tiuxetan: Given IV~Fludarabine: Given IV"
11073688|NCT01434641|BG000|Baseline|Myocardial Perfusion SPECT|The 102 study patients underwent a very low-activity stress/high-activity rest, single-day myocardial perfusion SPECT ith a conventional sodium iodide camera and wide beam reconstruction processing.
11073689|NCT01434641|FG000|Participant Flow|Stress/Rest Myocardial Perfusion SPECT Patients|All patients referred for clinically indicated myocardial perfusion SPECT are eligible candidates for this protocol. Low-dose stress/high-dose rest myocardial perfusion SPECT is performed according to the protocol and image quality and rest/stress myocardial count density ratios are assessed.
11073690|NCT01434641|OG000|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
11073691|NCT01434641|EG000|Reported Event|Myocardial Perfusion SPECT|
11073692|NCT01434654|BG000|Baseline|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073693|NCT01434654|BG001|Baseline|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073694|NCT01434654|BG002|Baseline|Total|Total of all reporting groups
11073695|NCT01434654|FG000|Participant Flow|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073696|NCT01434654|FG001|Participant Flow|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073697|NCT01434654|OG000|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073698|NCT01434654|OG001|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073699|NCT01434654|OG000|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073700|NCT01434654|OG001|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073701|NCT01434654|EG000|Reported Event|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073702|NCT01434654|EG001|Reported Event|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
11073703|NCT01434667|BG000|Baseline|APOE Genotype Non-Disclosure|"Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.~Alzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
11173550|NCT02016235|FG002|Participant Flow|Dent Disease Observation|"Dent disease subjects will not get phosphorus~Observation: Baseline blood and urine measurements only"
11073704|NCT01434667|BG001|Baseline|APOE Genotype Disclosure|"Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.~APOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
11073705|NCT01434667|BG002|Baseline|Total|Total of all reporting groups
11073706|NCT01434667|FG000|Participant Flow|Apolipoprotein E (APOE) Genotype Non-Disclosure|"Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.~Alzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
11073707|NCT01434667|FG001|Participant Flow|Apolipoprotein E (APOE) Genotype Disclosure|"Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.~APOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
11073708|NCT01434667|OG000|Outcome|APOE Genotype Non-Disclosure|"Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.~Alzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
11073709|NCT01434667|OG001|Outcome|APOE Genotype Disclosure|"Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.~APOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
11073710|NCT01434667|EG000|Reported Event|APOE Genotype Non-Disclosure|"Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.~Alzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
11073711|NCT01434667|EG001|Reported Event|APOE Genotype Disclosure|"Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.~APOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
11073712|NCT01434680|BG000|Baseline|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
11073713|NCT01434680|BG001|Baseline|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
11073714|NCT01434680|BG002|Baseline|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
11073715|NCT01434680|BG003|Baseline|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
11073716|NCT01434680|BG004|Baseline|Total|Total of all reporting groups
11073717|NCT01434680|FG000|Participant Flow|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
11073718|NCT01434680|FG001|Participant Flow|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
11073719|NCT01434680|FG002|Participant Flow|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
11073720|NCT01434680|FG003|Participant Flow|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
11073721|NCT01434680|OG000|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
11073722|NCT01434680|OG001|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
11073723|NCT01434680|OG002|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
11073724|NCT01434680|OG003|Outcome|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
11233726|NCT02430870|FG007|Participant Flow|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11349085|NCT04126187|EG000|Reported Event|Panoptix|"Bilateral implantation of the Panoptix trifocal IOL~Panoptix: Panoptix trifocal intraocular lens (IOL)"
11073725|NCT01434680|EG000|Reported Event|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
11073726|NCT01434680|EG001|Reported Event|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
11073727|NCT01434680|EG002|Reported Event|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
11073728|NCT01434680|EG003|Reported Event|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
11073729|NCT01434693|BG000|Baseline|Placebo|Placebo: single dose
11073730|NCT01434693|BG001|Baseline|TSO 500|Trichuris suis ova : single dose
11073731|NCT01434693|BG002|Baseline|TSO 2500|Trichuris suis ova : single dose
11073732|NCT01434693|BG003|Baseline|TSO 7500|Trichuris suis ova : single dose
11073733|NCT01434693|BG004|Baseline|Total|Total of all reporting groups
11073734|NCT01434693|FG000|Participant Flow|Placebo|Placebo: single dose
11073735|NCT01434693|FG001|Participant Flow|TSO 500|Trichuris suis ova : single dose
11073736|NCT01434693|FG002|Participant Flow|TSO 2500|Trichuris suis ova : single dose
11073737|NCT01434693|FG003|Participant Flow|TSO 7500|Trichuris suis ova : single dose
11073738|NCT01434693|OG000|Outcome|Placebo|Placebo: single dose
11073739|NCT01434693|OG001|Outcome|TSO 500|Trichuris suis ova : single dose
11073740|NCT01434693|OG002|Outcome|TSO 2500|Trichuris suis ova : single dose
11073741|NCT01434693|OG003|Outcome|TSO 7500|Trichuris suis ova : single dose
11073742|NCT01434693|EG000|Reported Event|Placebo|Placebo: single dose
11073743|NCT01434693|EG001|Reported Event|TSO 500|Trichuris suis ova : single dose
11073744|NCT01434693|EG002|Reported Event|TSO 2500|Trichuris suis ova : single dose
11073745|NCT01434693|EG003|Reported Event|TSO 7500|Trichuris suis ova : single dose
11073746|NCT01434810|BG000|Baseline|Filtered Sunlight Phototherapy|"Window tinting film will be used.~Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days."
11073747|NCT01434810|BG001|Baseline|Conventional Phototherapy|"Infants will be randomized to conventional phototherapy (new arm)~Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days."
11073748|NCT01434810|BG002|Baseline|Total|Total of all reporting groups
11073749|NCT01434810|FG000|Participant Flow|Filtered Sunlight Phototherapy|"Window tinting film will be used.~Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days."
11073750|NCT01434810|FG001|Participant Flow|Conventional Phototherapy|"Infants will be randomized to conventional phototherapy (new arm)~Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days."
11073751|NCT01434810|OG000|Outcome|Filtered Sunlight Phototherapy|"Window tinting film will be used.~Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days."
11073752|NCT01434810|OG001|Outcome|Conventional Phototherapy|"Infants will be randomized to conventional phototherapy (new arm)~Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days."
11073753|NCT01434810|EG000|Reported Event|Filtered Sunlight Phototherapy|"Window tinting film will be used.~Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days."
11349086|NCT04124952|BG000|Baseline|Panoptix|"Patients bilaterally implanted with the Panoptix intraocular lens.~Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)"
11073754|NCT01434810|EG001|Reported Event|Conventional Phototherapy|"Infants will be randomized to conventional phototherapy (new arm)~Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days."
11073755|NCT01434823|BG000|Baseline|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
11073756|NCT01434823|BG001|Baseline|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
11073757|NCT01434823|BG002|Baseline|Total|Total of all reporting groups
11073758|NCT01434823|FG000|Participant Flow|Intervention - Nocturnal Coverage|"Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.~Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay in secondary analyses."
11073759|NCT01434823|FG001|Participant Flow|Control - Standard of Care|"The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).~Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay."
11073760|NCT01434823|OG000|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
11073761|NCT01434823|OG001|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
11073762|NCT01434823|OG000|Outcome|Intervention - Nocturnal Coverage|"Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.~Nocturnal coverage: The investigators will randomize, by week, nocturnal coverage. During the intervention weeks, intensivists will be in the MICU from 7pm until 7am.~For the Intensivist Sleep and Work sub-study:~Measurements of Daytime Intensivist work hours, sleep, and attention will be measured with actigraphy, PVT, Sleep and Work Diaries, and Surveys. Results will be compared between periods with standard staffing to periods with overnight intensivist coverage."
11073763|NCT01434823|EG000|Reported Event|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
11073764|NCT01434823|EG001|Reported Event|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
11073765|NCT01435018|BG000|Baseline|BV+ART|Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073766|NCT01435018|BG001|Baseline|ET+ART|Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073767|NCT01435018|BG002|Baseline|PTX+ART|Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11349087|NCT04124952|FG000|Participant Flow|Panoptix|"Patients bilaterally implanted with the Panoptix intraocular lens.~Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)"
11073768|NCT01435018|BG003|Baseline|Total|Total of all reporting groups
11073769|NCT01435018|FG000|Participant Flow|BV+ART|Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073770|NCT01435018|FG001|Participant Flow|ET+ART|Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073771|NCT01435018|FG002|Participant Flow|PTX+ART|Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073772|NCT01435018|OG000|Outcome|ET+ART|Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073773|NCT01435018|OG001|Outcome|PTX+ART|Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073774|NCT01435018|OG000|Outcome|BV+ART|Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073775|NCT01435018|OG001|Outcome|ET+ART|Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073776|NCT01435018|OG002|Outcome|PTX+ART|Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073777|NCT01435018|EG000|Reported Event|Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF|Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073778|NCT01435018|EG001|Reported Event|Etoposide (ET) Plus Co-formulated EFV/FTC/TDF|Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073779|NCT01435018|EG002|Reported Event|Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF|Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
11073780|NCT01435031|BG000|Baseline|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
11073781|NCT01435031|FG000|Participant Flow|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
11073782|NCT01435031|OG000|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
11073783|NCT01435031|EG000|Reported Event|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
11073784|NCT01435122|BG000|Baseline|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
11073785|NCT01435122|FG000|Participant Flow|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
11073786|NCT01435122|OG000|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
11073787|NCT01435122|EG000|Reported Event|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
11073788|NCT01435174|BG000|Baseline|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
11073789|NCT01435174|FG000|Participant Flow|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
11073790|NCT01435174|OG000|Outcome|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
11073791|NCT01435174|EG000|Reported Event|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
11073792|NCT01435265|BG000|Baseline|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
11073793|NCT01435265|BG001|Baseline|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
11073794|NCT01435265|BG002|Baseline|Total|Total of all reporting groups
11073795|NCT01435265|FG000|Participant Flow|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
11073796|NCT01435265|FG001|Participant Flow|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
11073797|NCT01435265|OG000|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
11073798|NCT01435265|OG001|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
11073799|NCT01435265|EG000|Reported Event|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
11073800|NCT01435265|EG001|Reported Event|Additional Nurse Education|Experimental: Additional Nurse Education- Subjects will receive additional nurse education beyond the normal education materials provided by their physician
11073801|NCT01435304|BG000|Baseline|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
11073802|NCT01435304|BG001|Baseline|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
11073803|NCT01435304|BG002|Baseline|Total|Total of all reporting groups
11073804|NCT01435304|FG000|Participant Flow|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
11073805|NCT01435304|FG001|Participant Flow|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
11073806|NCT01435304|OG000|Outcome|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
11073807|NCT01435304|OG001|Outcome|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
11073808|NCT01435304|EG000|Reported Event|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
11073809|NCT01435304|EG001|Reported Event|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
11073810|NCT01435356|BG000|Baseline|recMage-A3 + AS15 ASCI|"MAGE A3 positive patients treated with recMAGE-A3 + AS15 ASCI~recMAGE-A3 + AS15 ASCI: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months"
11073811|NCT01435356|BG001|Baseline|Placebo|Placebo: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months
11073812|NCT01435356|BG002|Baseline|Total|Total of all reporting groups
11073813|NCT01435356|FG000|Participant Flow|recMage-A3 + AS15 ASCI|"MAGE A3 positive patients treated with recMAGE-A3 + AS15 ASCI~recMAGE-A3 + AS15 ASCI: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months"
11073814|NCT01435356|FG001|Participant Flow|Placebo|Placebo: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months
11073815|NCT01435356|OG000|Outcome|recMage-A3 + AS15 ASCI|"MAGE A3 positive patients treated with recMAGE-A3 + AS15 ASCI~recMAGE-A3 + AS15 ASCI: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months"
11073816|NCT01435356|OG001|Outcome|Placebo|Placebo: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months
11073817|NCT01435356|EG000|Reported Event|recMage-A3 + AS15 ASCI|"MAGE A3 positive patients treated with recMAGE-A3 + AS15 ASCI~recMAGE-A3 + AS15 ASCI: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months"
11073818|NCT01435356|EG001|Reported Event|Placebo|Placebo: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months
11073819|NCT01435382|BG000|Baseline|PF-04950615 IV 200 mg|Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.
11073820|NCT01435382|BG001|Baseline|PF-04950615 SC 200 mg (2 Injections of 1 mL)|Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85.
11349088|NCT04124952|OG000|Outcome|Panoptix|"Patients bilaterally implanted with the Panoptix intraocular lens.~Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)"
11073821|NCT01435382|BG002|Baseline|PF-04950615 SC 200 mg (1 Injection of 2 mL)|Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85.
11073822|NCT01435382|BG003|Baseline|PF-04950615 SC 100 mg (1 Injection of 1 mL)|Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85.
11073823|NCT01435382|BG004|Baseline|Total|Total of all reporting groups
11073824|NCT01435382|FG000|Participant Flow|PF-04950615 IV 200 mg|Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.
11073825|NCT01435382|FG001|Participant Flow|PF-04950615 SC 200 mg (2 Injections of 1 mL)|Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85.
11073826|NCT01435382|FG002|Participant Flow|PF-04950615 SC 200 mg (1 Injection of 2 mL)|Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85.
11073827|NCT01435382|FG003|Participant Flow|PF-04950615 SC 100 mg (1 Injection of 1 mL)|Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85.
11073828|NCT01435382|OG000|Outcome|PF-04950615 IV 200 mg|Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.
11073829|NCT01435382|OG001|Outcome|PF-04950615 SC 200 mg (2 Injections of 1 mL)|Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85.
11073830|NCT01435382|OG002|Outcome|PF-04950615 SC 200 mg (1 Injection of 2 mL)|Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85.
11073831|NCT01435382|OG003|Outcome|PF-04950615 SC 100 mg (1 Injection of 1 mL)|Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85.
11073832|NCT01435382|OG000|Outcome|PF-04950615 SC 200 mg (2 Injections of 1 mL)|Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85.
11073833|NCT01435382|OG001|Outcome|PF-04950615 SC 200 mg (1 Injection of 2 mL)|Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85.
11073834|NCT01435382|OG002|Outcome|PF-04950615 SC 100 mg (1 Injection of 1 mL)|Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85.
11073835|NCT01435382|OG000|Outcome|PF-04950615 SC 200 mg (2 Injections of 1mL): Injection 1|Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 1 mL at one quadrant of the two quadrants in abdomen. Participants were followed up to Day 85.
11073836|NCT01435382|OG001|Outcome|PF-04950615 SC 200 mg (2 Injections of 1mL): Injection 2|Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) at second quadrant of the two quadrants in abdomen. Participants were followed up to Day 85.
11073837|NCT01435382|OG003|Outcome|PF 04950615 SC 100 mg (1 Injection of 1 mL)|Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85.
11073838|NCT01435382|EG000|Reported Event|PF-04950615 IV 200 mg|Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.
11073839|NCT01435382|EG001|Reported Event|PF-04950615 SC 200 mg (2 Injections of 1 mL)|Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85.
11073840|NCT01435382|EG002|Reported Event|PF-04950615 SC 200 mg (1 Injection of 2 mL)|Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85.
11073841|NCT01435382|EG003|Reported Event|PF-04950615 SC 100 mg (1 Injection of 1 mL)|Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85.
11073842|NCT01435460|BG000|Baseline|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
11073843|NCT01435460|BG001|Baseline|Patanol|Ophthalmic solution containing olopatadine, 0.1%
11073844|NCT01435460|BG002|Baseline|Total|Total of all reporting groups
11073845|NCT01435460|FG000|Participant Flow|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
11073846|NCT01435460|FG001|Participant Flow|Patanol|Ophthalmic solution containing olopatadine, 0.1%
11073847|NCT01435460|OG000|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
11073848|NCT01435460|OG001|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
11073849|NCT01435460|EG000|Reported Event|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
11073850|NCT01435460|EG001|Reported Event|Patanol|Ophthalmic solution containing olopatadine, 0.1%
11073851|NCT01435512|BG000|Baseline|Group|"PTSD-Focused Cognitive Behavioral Therapy for Partner Violence~PTSD-Focused CBT for Partner Violence: PTSD-Focused CBT (PFCBT) will consist of 12 2-hour weekly sessions,led by two project therapists. In each session, group members will discuss materials and do assignments to practice skills."
11073852|NCT01435512|BG001|Baseline|Waitlist|Control group - no intervention
11073853|NCT01435512|BG002|Baseline|Total|Total of all reporting groups
11073854|NCT01435512|FG000|Participant Flow|PTSD-Focused Cognitive Behavioral Therapy for Partner Violence|"PTSD-Focused Cognitive Behavioral Therapy for Partner Violence~PTSD-Focused CBT for Partner Violence: PTSD-Focused CBT (PFCBT) will consist of 12 2-hour weekly sessions,led by two project therapists. In each session, group members will discuss materials and do assignments to practice skills."
11073855|NCT01435512|FG001|Participant Flow|Waitlist|Control group - no intervention. Participants who were randomized to the waitlist at baseline were offered PTSD-Focused Cognitive Behavioral Therapy for Partner Violence after the 3-month follow-up.
11073856|NCT01435512|OG000|Outcome|Group|"PTSD-Focused Cognitive Behavioral Therapy for Partner Violence~PTSD-Focused CBT for Partner Violence: PTSD-Focused CBT (PFCBT) will consist of 12 2-hour weekly sessions,led by two project therapists. In each session, group members will discuss materials and do assignments to practice skills."
11073857|NCT01435512|OG001|Outcome|Waitlist|Control group - no intervention
11073858|NCT01435512|EG000|Reported Event|PTSD-Focused Cognitive Behavioral Therapy Group|"PTSD-Focused Cognitive Behavioral Therapy for Partner Violence~PTSD-Focused CBT for Partner Violence: PTSD-Focused CBT (PFCBT) will consist of 12 2-hour weekly sessions,led by two project therapists. In each session, group members will discuss materials and do assignments to practice skills."
11073859|NCT01435512|EG001|Reported Event|Control Group|"Control Group~Control Group: The study utilized a wait list control. Individuals on the wait list did not receive an intervention."
11073860|NCT01435577|BG000|Baseline|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
11073861|NCT01435577|BG001|Baseline|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
11073862|NCT01435577|BG002|Baseline|Total|Total of all reporting groups
11073863|NCT01435577|FG000|Participant Flow|Tapentadol Intravenous|"Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.~64 Participants Randomized, 64 Participants in the Safety Set (SAF), 64 Participants in the Full Analysis Set (FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
11073864|NCT01435577|FG001|Participant Flow|Matching Placebo Intravenous|"Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.~65 Randomized participants, 65 Participants in the Safety Set (SAF), 65 Participants in the Full Analysis Set(FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
11073865|NCT01435577|OG000|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
11073866|NCT01435577|OG001|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
11073867|NCT01435577|OG000|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
11073868|NCT01435577|OG000|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone. Values collected after 12 hours were censored, i.e. participants scored as having no meaningful pain relief.
11073869|NCT01435577|OG000|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
11073870|NCT01435577|OG000|Outcome|Matching Placebo Intravenous|Matching Placebo will be given by intravenous infusion. Matching Placebo will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
11073871|NCT01435577|EG000|Reported Event|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
11073872|NCT01435577|EG001|Reported Event|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
11073873|NCT01435603|BG000|Baseline|Standard Lifestyle Advice|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).~Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."
11073874|NCT01435603|BG001|Baseline|Advice Plus Lifestyle Intervention|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.~Standard Lifestyle Advice: See Standard Lifestyle Advice arm.~Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team."
11073875|NCT01435603|BG002|Baseline|Total|Total of all reporting groups
11073876|NCT01435603|FG000|Participant Flow|Standard Lifestyle Advice|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).~Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."
11073877|NCT01435603|FG001|Participant Flow|Advice Plus Lifestyle Intervention|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.~Standard Lifestyle Advice: See Standard Lifestyle Advice arm.~Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team."
11073878|NCT01435603|OG000|Outcome|Standard Lifestyle Advice|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).~Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."
11173551|NCT02016235|OG000|Outcome|Dent Disease Intervention|"Dent Disease subjects will receive 2 week supplementation with phosphorus~Phosphorus Supplement: 250 mg po qid"
11173552|NCT02016235|OG001|Outcome|Kidney Stone Subjects|"Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus~Phosphorus Supplement: 250 mg po qid"
11073879|NCT01435603|OG001|Outcome|Advice Plus Lifestyle Intervention|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.~Standard Lifestyle Advice: See Standard Lifestyle Advice arm.~Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team."
11073880|NCT01435603|EG000|Reported Event|Standard Lifestyle Advice|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).~Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."
11073881|NCT01435603|EG001|Reported Event|Advice Plus Lifestyle Intervention|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.~Standard Lifestyle Advice: See Standard Lifestyle Advice arm.~Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team."
11073882|NCT01435616|BG000|Baseline|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
11073883|NCT01435616|BG001|Baseline|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
11073884|NCT01435616|BG002|Baseline|Total|Total of all reporting groups
11073885|NCT01435616|FG000|Participant Flow|LY2605541|LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks
11073886|NCT01435616|FG001|Participant Flow|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
11073887|NCT01435616|OG000|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
11073888|NCT01435616|OG001|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
11073889|NCT01435616|OG000|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
11073890|NCT01435616|OG001|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
11073891|NCT01435616|EG000|Reported Event|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
11073892|NCT01435616|EG001|Reported Event|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
11073893|NCT01435655|BG000|Baseline|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
11073894|NCT01435655|FG000|Participant Flow|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
11073895|NCT01435655|OG000|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
11073896|NCT01435655|EG000|Reported Event|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
11073897|NCT01435759|BG000|Baseline|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
11073898|NCT01435759|BG001|Baseline|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
11073899|NCT01435759|BG002|Baseline|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
11073900|NCT01435759|BG003|Baseline|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
11073901|NCT01435759|BG004|Baseline|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
11073902|NCT01435759|BG005|Baseline|Total|Total of all reporting groups
11073903|NCT01435759|FG000|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).
11073904|NCT01435759|FG001|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
11073905|NCT01435759|FG002|Participant Flow|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
11073906|NCT01435759|FG003|Participant Flow|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
11073907|NCT01435759|FG004|Participant Flow|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
11073908|NCT01435759|FG005|Participant Flow|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
11073909|NCT01435759|OG000|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
11073910|NCT01435759|OG001|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
11073911|NCT01435759|OG002|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
11073912|NCT01435759|OG003|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
11073913|NCT01435759|OG004|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
11073914|NCT01435759|EG000|Reported Event|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
11073915|NCT01435759|EG001|Reported Event|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
11073916|NCT01435759|EG002|Reported Event|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
11073917|NCT01435759|EG003|Reported Event|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
11073918|NCT01435759|EG004|Reported Event|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
11073919|NCT01435772|BG000|Baseline|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
11073920|NCT01435772|BG001|Baseline|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
11073921|NCT01435772|BG002|Baseline|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
11073922|NCT01435772|BG003|Baseline|Total|Total of all reporting groups
11073923|NCT01435772|FG000|Participant Flow|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
11073924|NCT01435772|FG001|Participant Flow|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
11073925|NCT01435772|FG002|Participant Flow|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
11073926|NCT01435772|OG000|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
11073927|NCT01435772|OG001|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
11073928|NCT01435772|OG002|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
11073929|NCT01435772|EG000|Reported Event|BMN 701 5 mg/kg|BMN 701 5 mg/kg
11073930|NCT01435772|EG001|Reported Event|BMN 701 10 mg/kg|BMN 701 10 mg/kg
11073931|NCT01435772|EG002|Reported Event|BMN 701 20 mg/kg|BMN 701 20 mg/kg
11073932|NCT01435772|EG003|Reported Event|Total|Total
11073933|NCT01435798|BG000|Baseline|Dextromethorphan Dose Response Clinical Trial|Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here).
11073934|NCT01435798|FG000|Participant Flow|Dextromethorphan Dose Response (DDR) Clinical Trial|Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here).
11073935|NCT01435798|OG000|Outcome|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
11073936|NCT01435798|OG001|Outcome|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
11073937|NCT01435798|OG002|Outcome|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
11073938|NCT01435798|OG003|Outcome|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
11073939|NCT01435798|EG000|Reported Event|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
11073940|NCT01435798|EG001|Reported Event|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
11349089|NCT04124952|EG000|Reported Event|Panoptix|"Patients bilaterally implanted with the Panoptix intraocular lens.~Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)"
11073941|NCT01435798|EG002|Reported Event|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
11073942|NCT01435798|EG003|Reported Event|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
11073943|NCT01435824|BG000|Baseline|Entire Study Population|This study was designed as a randomized 2x2 crossover single-dose study where participants either given water-dissolved amoxicillin first or human milk-dissolved amoxicillin first switched over during period 2.
11073944|NCT01435824|FG000|Participant Flow|Water-based First, Then Milk-based Administration|First, participants were orally given 10 mL of water-dissolved amoxicillin (50mg/mL) in a fasting state. A PK sampling was performed. The washout period was for 1-2 weeks and then participants underwent the milk-based administration of amoxicillin, followed by PK sampling.
11073945|NCT01435824|FG001|Participant Flow|Milk-based First, and Then Water-based Drug Administration|First, participants were orally given 10 mL of human milk-dissolved amoxicillin (50mg/mL) in fasting state, followed by PK sampling. The washout period was for 1-2 weeks and then participants underwent a water-based administration if amoxicillin followed by PK sampling. .
11073946|NCT01435824|OG000|Outcome|Water as a Vehicle of Amoxicillin|"Amoxicillin 500 mg was dissolved in 10 ml water and orally administered in a fasting state.~Water-dissolved amoxicillin: An amoxicillin suspension bottle containing 5 grams of amoxicillin (powder) will be resuspended in 60 ml of water to have 100mL of a 50mg/mL suspension."
11073947|NCT01435824|OG001|Outcome|Human Milk as a Vehicle of Amoxicillin|"Amoxicillin 500 mg was dissolved in 10 ml human milk and orally administered in a fasting state.~Human milk-dissolved amoxicillin: An amoxicillin suspension bottle containing 5 grams of amoxicillin (powder) will be resuspended in 60 ml of breast milk to have 100mL of a 50mg/mL suspension."
11073948|NCT01435824|EG000|Reported Event|Water-based Amoxicillin Administration|Amoxicillin was dissolved in water and administered for PK sampling.
11073949|NCT01435824|EG001|Reported Event|Human Milk-based Amoxicillin Administration|Amoxicillin was dissolved in human milk and administered for PK sampling.
11073950|NCT01435928|BG000|Baseline|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
11073951|NCT01435928|BG001|Baseline|Placebo|During double blind phase subjects received matching placebo.
11073952|NCT01435928|BG002|Baseline|Total|Total of all reporting groups
11073953|NCT01435928|FG000|Participant Flow|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
11073954|NCT01435928|FG001|Participant Flow|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
11073955|NCT01435928|FG002|Participant Flow|Placebo|During double blind phase subjects received matching placebo.
11073956|NCT01435928|OG000|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
11073957|NCT01435928|OG001|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
11073958|NCT01435928|EG000|Reported Event|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
11073959|NCT01435928|EG001|Reported Event|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
11073960|NCT01435928|EG002|Reported Event|Placebo|During double blind phase subjects received matching placebo.
11073961|NCT01436006|BG000|Baseline|CT Scan|patient with cancer
11073962|NCT01436006|FG000|Participant Flow|CT Scan|"A total of 65 radiology departments, with 70 MDCT scanners, collected data of 5942 adult patients, randomly chosen, who underwent to CT examinations for common clinical for 5 common different protocols including also new examination that will be in the near future common practise as cardiac CT.~A prevalence of multiphasic study was documented in many chest abdomen and pelvis (CAP) studies and abdominal studies."
11073963|NCT01436006|OG000|Outcome|Adult|Adult patients submitted to head CT scan
11073964|NCT01436006|OG001|Outcome|Pediatric|Pediatric patients submitted to head CT scan
11073965|NCT01436006|OG000|Outcome|Chest CT- Adult|Adult patients submitted to chest CT
11073966|NCT01436006|OG001|Outcome|Chest CT- Pediatric|Pediatric patients submitted to chest CT
11073967|NCT01436006|OG000|Outcome|Abdomen CT Adults|Adult patients submitted to abdomen CT
11227329|NCT02382640|BG003|Baseline|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
11227330|NCT02382640|BG004|Baseline|Total|Total of all reporting groups
11227331|NCT02382640|FG000|Participant Flow|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
11227332|NCT02382640|FG001|Participant Flow|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
11227333|NCT02382640|FG002|Participant Flow|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
11227334|NCT02382640|FG003|Participant Flow|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
11227335|NCT02382640|OG000|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
11227336|NCT02382640|OG001|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
11227337|NCT02382640|OG002|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
11227338|NCT02382640|OG003|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
11227339|NCT02382640|EG000|Reported Event|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
11227340|NCT02382640|EG001|Reported Event|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
11227341|NCT02382640|EG002|Reported Event|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
11227342|NCT02382640|EG003|Reported Event|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
11227343|NCT02382705|BG000|Baseline|PillCam SB3EX|All participants in the study used the PillCam SB3EX for their capsule endoscopy
11227344|NCT02382705|FG000|Participant Flow|PillCam SB3EX|All participants in the study used the PillCam SB3EX for their capsule endoscopy
11073968|NCT01436006|OG001|Outcome|Abdomen CT Pediatric|Pediatric patients submitted to abdomen CT
11073969|NCT01436006|OG000|Outcome|Adult Cardiac CT|Adult patients submitted to cardiac CT
11227345|NCT02382705|OG000|Outcome|PillCam SB3EX|
11227346|NCT02382705|EG000|Reported Event|PillCam SB3EX|Patients who were eligible to participate in the study were recruited and enrolled. Enrolled participants were given instructions for capsule endoscopy as per standard of practice at our institution. External sensors and data recorder for use with the PillCam capsule were placed. Patients swallowed the capsule. All capsule endoscopy were allowed to run/record until the recording terminates due to battery outage (usually after 12 h) or passage of CE out of the gastrointestinal tract, as indicated by cessation of flashing light on the recorder. External sensors and data recorder were removed at the end of the recording and patients returned the equipment to the institution the next day.
11227347|NCT02382744|BG000|Baseline|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
11227348|NCT02382744|BG001|Baseline|Ultrasound Guidance and Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
11073970|NCT01436006|OG000|Outcome|Adult Patient Chest Abdomen and Pelvis|Adult patients submitted to chest abdomen and pelvis CT examinations.
11073971|NCT01436006|OG000|Outcome|CT Adult Spine|Adult patients submitted to spine CT
11073972|NCT01436006|EG000|Reported Event|Adverse Reaction to CT|Patients submitted to CT
11073973|NCT01436045|BG000|Baseline|All Study Partipants|Participants who received either intranasal glulisine (0.10 milliliter (mL) in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
11073974|NCT01436045|FG000|Participant Flow|Insulin Glulisine, Then Placebo|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.~Insulin glulisine (5 minutes), Washout (1 week), Placebo (5 minutes)~Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)~Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
11073975|NCT01436045|FG001|Participant Flow|Placebo, Then Insulin Glulisine|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.~Placebo (5 minutes), Washout (1 week), Insulin Glulisine (5 minutes)~Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)~Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
11073976|NCT01436045|OG000|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
11073977|NCT01436045|OG001|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
11227349|NCT02382744|BG002|Baseline|Total|Total of all reporting groups
11227350|NCT02382744|FG000|Participant Flow|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
11227351|NCT02382744|FG001|Participant Flow|Ultrasound Guidance and Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
11227352|NCT02382744|OG000|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
11227353|NCT02382744|OG001|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
11227354|NCT02382744|OG000|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
11227355|NCT02382744|OG000|Outcome|Ultrasound Guidance and Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
11227356|NCT02382744|OG000|Outcome|Responders to Nerve Stimulation|Participants in the Ultrasound Guidance and Nerve Stimulation group with response to nerve stimulation
11227357|NCT02382744|OG001|Outcome|Non-responders to Nerve Stimulation|participants in the Ultrasound Guidance and Nerve Stimulation group with no response to nerve stimulation
11227358|NCT02382744|EG000|Reported Event|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
11227359|NCT02382744|EG001|Reported Event|Ultrasound Guidance and Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
11227360|NCT02382796|BG000|Baseline|Dacomitinib|Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]). Dacomitinib was provided as tablets for oral administration.
11073978|NCT01436045|OG001|Outcome|Post Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
11073979|NCT01436045|EG000|Reported Event|All Study Partipants|Participants who received either intranasal glulisine (0.10 mL in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
11073980|NCT01436071|BG000|Baseline|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073981|NCT01436071|BG001|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073982|NCT01436071|BG002|Baseline|Total|Total of all reporting groups
11073983|NCT01436071|FG000|Participant Flow|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073984|NCT01436071|FG001|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073985|NCT01436071|OG000|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073986|NCT01436071|OG001|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073987|NCT01436071|EG000|Reported Event|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073988|NCT01436071|EG001|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073989|NCT01436110|BG000|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073990|NCT01436110|BG001|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073991|NCT01436110|BG002|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073992|NCT01436110|BG003|Baseline|Total|Total of all reporting groups
11073993|NCT01436110|FG000|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073994|NCT01436110|FG001|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073995|NCT01436110|FG002|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073996|NCT01436110|OG000|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073997|NCT01436110|OG001|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073998|NCT01436110|OG002|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11073999|NCT01436110|EG000|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11074000|NCT01436110|EG001|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11074001|NCT01436110|EG002|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
11074002|NCT01436149|BG000|Baseline|Antidepressant + Double-blind Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
11074003|NCT01436149|BG001|Baseline|Antidepressant + Double-blind SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose) for 8 weeks.
11074004|NCT01436149|BG002|Baseline|Total|Total of all reporting groups
11074005|NCT01436149|FG000|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended-release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
11173553|NCT02016235|OG002|Outcome|Dent Disease Observation|"Dent disease subjects will not get phosphorus~Observation: Baseline blood and urine measurements only. Day 7 Urine total protein not obtained"
11173554|NCT02016235|EG000|Reported Event|Dent Disease Intervention|"Dent Disease subjects will receive 2 week supplementation with phosphorus~Phosphorus Supplement: 250 mg po qid"
11074006|NCT01436149|FG001|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
11074007|NCT01436149|FG002|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose).
11074008|NCT01436149|OG000|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
11074009|NCT01436149|OG001|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
11074010|NCT01436149|EG000|Reported Event|Antidepressant + Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
11074011|NCT01436149|EG001|Reported Event|Antidepressant + SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50 or 70 mg dose).
11074012|NCT01436162|BG000|Baseline|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose) for 8 weeks.
11074013|NCT01436162|BG001|Baseline|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
11074014|NCT01436162|BG002|Baseline|Total|Total of all reporting groups
11074015|NCT01436162|FG000|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
11074016|NCT01436162|FG001|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose).
11074017|NCT01436162|FG002|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
11074018|NCT01436162|OG000|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
11233727|NCT02430870|OG000|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11074019|NCT01436162|OG001|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
11074020|NCT01436162|OG000|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
11074021|NCT01436162|OG001|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
11074022|NCT01436162|EG000|Reported Event|SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate ): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
11074023|NCT01436162|EG001|Reported Event|Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
11074024|NCT01436175|BG000|Baseline|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
11074025|NCT01436175|FG000|Participant Flow|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
11074026|NCT01436175|OG000|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
11074027|NCT01436175|OG000|Outcome|SPD489 + Antidepressant|SPD489 (Lisdexamfetamine dimesylate) + Antidepressant: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
11074028|NCT01436175|EG000|Reported Event|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
11074029|NCT01436201|BG000|Baseline|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
11074030|NCT01436201|FG000|Participant Flow|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
11074031|NCT01436201|OG000|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
11074032|NCT01436201|OG001|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
11074033|NCT01436201|EG000|Reported Event|Digoxin|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
11074034|NCT01436201|EG001|Reported Event|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
11074035|NCT01436266|BG000|Baseline|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
11074036|NCT01436266|BG001|Baseline|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
11074037|NCT01436266|BG002|Baseline|Total|Total of all reporting groups
11074038|NCT01436266|FG000|Participant Flow|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
11074039|NCT01436266|FG001|Participant Flow|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
11074040|NCT01436266|OG000|Outcome|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
11074041|NCT01436266|OG001|Outcome|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
11074042|NCT01436266|EG000|Reported Event|Misoprostol|"400 mcg buccally 2 hours prior to procedure~Misoprostol: 400 mcg buccally 2 hours prior to procedure"
11074043|NCT01436266|EG001|Reported Event|Placebo (Folic Acid)|"Two 1-mg tablets buccally 2 hours prior to procedure~Folic acid: 2mg buccally 2 hours prior to procedure"
11074044|NCT01436279|BG000|Baseline|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
11074045|NCT01436279|BG001|Baseline|Osmotic Dilators|Placed 20-24 hours prior to procedure
11074046|NCT01436279|BG002|Baseline|Total|Total of all reporting groups
11074047|NCT01436279|FG000|Participant Flow|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
11074048|NCT01436279|FG001|Participant Flow|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
11074049|NCT01436279|OG000|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
11074050|NCT01436279|OG001|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
11074051|NCT01436279|OG000|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
11074052|NCT01436279|OG001|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
11074053|NCT01436279|EG000|Reported Event|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
11074054|NCT01436279|EG001|Reported Event|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
11074055|NCT01436305|BG000|Baseline|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
11173555|NCT02016235|EG001|Reported Event|Kidney Stone Subjects|"Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus~Phosphorus Supplement: 250 mg po qid"
11173556|NCT02016235|EG002|Reported Event|Dent Disease Observation|"Dent disease subjects will not get phosphorus~Observation: Baseline blood and urine measurements only. Day 7 Urine total protein not obtained"
11173557|NCT02016300|BG000|Baseline|Unloader Bracing|This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
11173558|NCT02016300|BG001|Baseline|Non-Bracing Arm|This group was randomly selected and assigned to wear no brace post-operatively.
11227361|NCT02382796|FG000|Participant Flow|Dacomitinib|Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]). Dacomitinib was provided as tablets for oral administration.
11227362|NCT02382796|OG000|Outcome|Dacomitinib|Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]). Dacomitinib was provided as tablets for oral administration.
11227363|NCT02382796|EG000|Reported Event|Dacomitinib|Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]). Dacomitinib was provided as tablets for oral administration.
11227364|NCT02382848|BG000|Baseline|All Study Participants|All participants received Prazosin (1mg capsule) and Placebo during the course of the research study.
11227365|NCT02382848|FG000|Participant Flow|Prazosin, Then Placebo|A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily. After a washout period of 1 week, they then will receive matching placebo pill.
11227366|NCT02382848|FG001|Participant Flow|Placebo, Then Pazosin|"Placebo will be given for a 3 consecutive week period during the 7 week study period. After a washout period of 1 week, they then will be given Prazosin matched pill (1mg capsule). Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.~Placebo: Placebo (sugar pill) is used for 3 weeks."
11074056|NCT01436305|BG001|Baseline|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
11091860|NCT01536496|EG000|Reported Event|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
11227367|NCT02382848|OG000|Outcome|Prazosin|A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.
11227368|NCT02382848|OG001|Outcome|Placebo|"Placebo will be given for a 3 consecutive week period during the 7 week study period.~Placebo: Placebo (sugar pill) is used for 3 weeks."
11227369|NCT02382848|EG000|Reported Event|Prazosin|A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.
11227370|NCT02382848|EG001|Reported Event|Placebo|"Placebo will be given for a 3 consecutive week period during the 7 week study period.~Placebo: Placebo (sugar pill) is used for 3 weeks."
11227371|NCT02382913|BG000|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227372|NCT02382913|BG001|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227373|NCT02382913|BG002|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227374|NCT02382913|BG003|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227375|NCT02382913|BG004|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11074057|NCT01436305|BG002|Baseline|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
11074058|NCT01436305|BG003|Baseline|Total|Total of all reporting groups
11074059|NCT01436305|FG000|Participant Flow|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
11074060|NCT01436305|FG001|Participant Flow|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
11074061|NCT01436305|FG002|Participant Flow|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
11074062|NCT01436305|OG000|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
11074063|NCT01436305|OG001|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
11074064|NCT01436305|OG002|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
11173559|NCT02016300|BG002|Baseline|Total|Total of all reporting groups
11173560|NCT02016300|FG000|Participant Flow|Unloader Bracing|This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
11173561|NCT02016300|FG001|Participant Flow|Non-Bracing Arm|This group was randomly selected and assigned to wear no brace post-operatively.
11173562|NCT02016300|OG000|Outcome|Unloader Bracing|This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
11074065|NCT01436305|EG000|Reported Event|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
11074066|NCT01436305|EG001|Reported Event|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
11074067|NCT01436305|EG002|Reported Event|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
11074068|NCT01436357|BG000|Baseline|AdCh3NSmut1 and MVA-NSmut|One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
11074069|NCT01436357|BG001|Baseline|Sodium Chloride Placebo|Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
11074070|NCT01436357|BG002|Baseline|Total|Total of all reporting groups
11074071|NCT01436357|FG000|Participant Flow|AdCh3NSmut1 and MVA-NSmut|One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
11074072|NCT01436357|FG001|Participant Flow|Sodium Chloride Placebo|Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
11074073|NCT01436357|OG000|Outcome|AdCh3NSmut1 and MVA-NSmut|One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
11074074|NCT01436357|OG001|Outcome|Sodium Chloride Placebo|Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
11074075|NCT01436357|EG000|Reported Event|AdCh3NSmut1 and MVA-NSmut|One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
11074076|NCT01436357|EG001|Reported Event|Sodium Chloride Placebo|Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
11074077|NCT01436370|BG000|Baseline|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
11074078|NCT01436370|BG001|Baseline|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
11074079|NCT01436370|BG002|Baseline|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074080|NCT01436370|BG003|Baseline|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074081|NCT01436370|BG004|Baseline|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074082|NCT01436370|BG005|Baseline|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074083|NCT01436370|BG006|Baseline|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074084|NCT01436370|BG007|Baseline|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074085|NCT01436370|BG008|Baseline|Total|Total of all reporting groups
11074086|NCT01436370|FG000|Participant Flow|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
11074087|NCT01436370|FG001|Participant Flow|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
11074088|NCT01436370|FG002|Participant Flow|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074089|NCT01436370|FG003|Participant Flow|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074090|NCT01436370|FG004|Participant Flow|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074091|NCT01436370|FG005|Participant Flow|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074092|NCT01436370|FG006|Participant Flow|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074093|NCT01436370|FG007|Participant Flow|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074094|NCT01436370|OG000|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
11074095|NCT01436370|OG001|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074096|NCT01436370|OG001|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
11074097|NCT01436370|OG002|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074098|NCT01436370|OG003|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074099|NCT01436370|OG004|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074100|NCT01436370|OG005|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074101|NCT01436370|OG006|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074102|NCT01436370|OG007|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074103|NCT01436370|OG000|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074104|NCT01436370|OG001|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074105|NCT01436370|OG002|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074106|NCT01436370|OG003|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074107|NCT01436370|OG001|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074108|NCT01436370|OG002|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074109|NCT01436370|OG003|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074110|NCT01436370|EG000|Reported Event|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
11074111|NCT01436370|EG001|Reported Event|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
11074112|NCT01436370|EG002|Reported Event|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074113|NCT01436370|EG003|Reported Event|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
11074114|NCT01436370|EG004|Reported Event|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074115|NCT01436370|EG005|Reported Event|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
11074116|NCT01436370|EG006|Reported Event|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074117|NCT01436370|EG007|Reported Event|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
11074118|NCT01436435|BG000|Baseline|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
11074119|NCT01436435|FG000|Participant Flow|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
11074120|NCT01436435|OG000|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
11074121|NCT01436435|EG000|Reported Event|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
11074122|NCT01436500|BG000|Baseline|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
11074123|NCT01436500|BG001|Baseline|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
11074124|NCT01436500|BG002|Baseline|Total|Total of all reporting groups
11074125|NCT01436500|FG000|Participant Flow|5 mg Ifetroban|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
11074126|NCT01436500|FG001|Participant Flow|15 mg Ifetroban|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
11074127|NCT01436500|FG002|Participant Flow|50 mg Ifetroban|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
11074128|NCT01436500|FG003|Participant Flow|150 mg Ifetroban|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
11074129|NCT01436500|FG004|Participant Flow|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
11074130|NCT01436500|OG000|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
11074131|NCT01436500|OG001|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
11074132|NCT01436500|OG002|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
11074133|NCT01436500|OG003|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
11074134|NCT01436500|OG004|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
11074135|NCT01436500|OG005|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
11074136|NCT01436500|OG006|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
11074137|NCT01436500|OG000|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
11074138|NCT01436500|OG001|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
11074139|NCT01436500|EG000|Reported Event|Ifetroban|5, 15, 50 or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
11074140|NCT01436500|EG001|Reported Event|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
11074141|NCT01436526|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg , Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
11074142|NCT01436526|BG001|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
11074143|NCT01436526|BG002|Baseline|Total|Total of all reporting groups
11074144|NCT01436526|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg, Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
11074145|NCT01436526|FG001|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
11074146|NCT01436526|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
11074147|NCT01436526|OG001|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
11074148|NCT01436526|EG000|Reported Event|Rivaroxaban 2*5 mg (Xarelto, BAY59-7939)|Single oral dose of 2*5 mg rivaroxaban tablets administered under fasting conditions
11074149|NCT01436526|EG001|Reported Event|Rivaroxaban 1*10 mg (Xarelto, BAY59-7939)|Single oral dose of 1*10 mg rivaroxaban tablet administered under fasting conditions
11074150|NCT01436643|BG000|Baseline|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
11074151|NCT01436643|BG001|Baseline|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
11074152|NCT01436643|BG002|Baseline|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
11074153|NCT01436643|BG003|Baseline|Total|Total of all reporting groups
11173563|NCT02016300|OG001|Outcome|Non-Bracing Arm|This group was randomly selected and assigned to wear no brace post-operatively.
11074154|NCT01436643|FG000|Participant Flow|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
11074155|NCT01436643|FG001|Participant Flow|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
11074156|NCT01436643|FG002|Participant Flow|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
11074157|NCT01436643|FG003|Participant Flow|Pre-treatment With Fingolimod|During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.
11074158|NCT01436643|OG000|Outcome|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
11074159|NCT01436643|OG001|Outcome|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
11074160|NCT01436643|OG002|Outcome|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
11074161|NCT01436643|OG003|Outcome|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
11074162|NCT01436643|EG000|Reported Event|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
11074163|NCT01436643|EG001|Reported Event|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
11074164|NCT01436643|EG002|Reported Event|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
11074165|NCT01436643|EG003|Reported Event|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
11074166|NCT01436799|BG000|Baseline|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
11074167|NCT01436799|BG001|Baseline|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
11074168|NCT01436799|BG002|Baseline|Total|Total of all reporting groups
11074169|NCT01436799|FG000|Participant Flow|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
11074170|NCT01436799|FG001|Participant Flow|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
11074171|NCT01436799|OG000|Outcome|Desflurane|anesthetic maintenence with desflurane
11074172|NCT01436799|OG001|Outcome|Propofol|anesthetic maintanence with propofol
11074173|NCT01436799|EG000|Reported Event|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
11074174|NCT01436799|EG001|Reported Event|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
11074175|NCT01437098|BG000|Baseline|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
11074176|NCT01437098|FG000|Participant Flow|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
11074177|NCT01437098|OG000|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
11074178|NCT01437098|OG001|Outcome|Iliofemoral Implanted Subjects|The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
11074179|NCT01437098|OG000|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
11074180|NCT01437098|OG000|Outcome|As Treated (AT) Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
11074181|NCT01437098|OG000|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
11074182|NCT01437098|OG000|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
11074183|NCT01437098|EG000|Reported Event|Iliofemoral (As Treated Subjects)|The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients.
11074184|NCT01437098|EG001|Reported Event|Subclavian (As Treated Subjects)|The subclavian access is additionally chosen (as the secondary access site) when physicians may require an alternative to the femoral access site for patients who would benefit from the therapy but have unfavorable peripheral vasculature such as excessive atherosclerosis, calcifications, or tortuosity of common femoral arteries.
11074185|NCT01437098|EG002|Reported Event|Direct Aortic (As Treated Subjects)|For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in oversea(EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches.
11074186|NCT01437098|EG003|Reported Event|All Subjects (As Treated Subjects)|This includes subjects from all access approaches, iliofemoral, subclavian and direct aortic.
11074187|NCT01437124|BG000|Baseline|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
11074188|NCT01437124|FG000|Participant Flow|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
11074189|NCT01437124|OG000|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
11074190|NCT01437124|EG000|Reported Event|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
11074191|NCT01437267|BG000|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11074192|NCT01437267|BG001|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
11074193|NCT01437267|BG002|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11074194|NCT01437267|BG003|Baseline|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
11074195|NCT01437267|BG004|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
11074196|NCT01437267|BG005|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
11074197|NCT01437267|BG006|Baseline|Total|Total of all reporting groups
11074198|NCT01437267|FG000|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11074199|NCT01437267|FG001|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
11074200|NCT01437267|FG002|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11074201|NCT01437267|FG003|Participant Flow|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
11074202|NCT01437267|FG004|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
11074203|NCT01437267|FG005|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
11074204|NCT01437267|OG000|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11074205|NCT01437267|OG001|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
11074206|NCT01437267|OG002|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11074207|NCT01437267|OG003|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
11074208|NCT01437267|OG004|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
11074209|NCT01437267|OG005|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
11074210|NCT01437267|EG000|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11074211|NCT01437267|EG001|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
11074212|NCT01437267|EG002|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
11074213|NCT01437267|EG003|Reported Event|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
11074214|NCT01437267|EG004|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
11074215|NCT01437267|EG005|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
11074216|NCT01437319|BG000|Baseline|Overall|The analysis population consists of all subjects that were enrolled into the study.
11074217|NCT01437319|FG000|Participant Flow|Lotrafilcon A|All subjects received lotrafilcon A in Phase I.
11074218|NCT01437319|FG001|Participant Flow|Comfilcon A|Subjects that received comfilcon A lens in Phase II.
11074219|NCT01437319|FG002|Participant Flow|Balfilcon A|Subjects that received balafilcon A lens in Phase II.
11074220|NCT01437319|OG000|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former.
11074221|NCT01437319|OG001|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former.
11074222|NCT01437319|OG000|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former
11074223|NCT01437319|OG001|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former
11074224|NCT01437319|EG000|Reported Event|Comfilcon A|Subjects who received comfilcon A in Phase II of the study.
11074225|NCT01437319|EG001|Reported Event|Balafilcon A|Subjects who received balafilcon A in Phase II of the study
11074226|NCT01437319|EG002|Reported Event|Lotrafilcon A|All Subjects received lotrafilcon A in Phase I of the study.
11074227|NCT01437397|BG000|Baseline|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
11074228|NCT01437397|BG001|Baseline|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
11074229|NCT01437397|BG002|Baseline|Aclidinium 400 μg|Administered BID by inhalation
11074230|NCT01437397|BG003|Baseline|Formoterol 12 μg|Administered BID by inhalation
11074231|NCT01437397|BG004|Baseline|Placebo|Administered BID by inhalation
11074232|NCT01437397|BG005|Baseline|Total|Total of all reporting groups
11074233|NCT01437397|FG000|Participant Flow|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
11074234|NCT01437397|FG001|Participant Flow|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
11074235|NCT01437397|FG002|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation
11074236|NCT01437397|FG003|Participant Flow|Formoterol 12 μg|Administered BID by inhalation
11074237|NCT01437397|FG004|Participant Flow|Placebo|Administered BID by inhalation
11074238|NCT01437397|OG000|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
11074239|NCT01437397|OG001|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
11074240|NCT01437397|OG002|Outcome|Aclidinium 400 μg|Administered BID by inhalation
11074241|NCT01437397|OG003|Outcome|Formoterol 12 μg|Administered BID by inhalation
11074242|NCT01437397|OG004|Outcome|Placebo|Administered BID by inhalation
11074243|NCT01437397|EG000|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
11074244|NCT01437397|EG001|Reported Event|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
11074245|NCT01437397|EG002|Reported Event|Aclidinium 400 μg|Administered BID by inhalation
11074246|NCT01437397|EG003|Reported Event|Formoterol 12 μg|Administered BID by inhalation
11074247|NCT01437397|EG004|Reported Event|Placebo|Administered BID by inhalation
11074248|NCT01437449|BG000|Baseline|Cisplatin + Docetaxel + Cetuximab|"Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.~Docetaxel: 30 mg/m² by intravenous (IV) administration~Cisplatin: 30 mg/m² by intravenous (IV) administration~Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV~Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration"
11074249|NCT01437449|FG000|Participant Flow|Cisplatin + Docetaxel + Cetuximab|"Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.~Docetaxel: 30 mg/m² by intravenous (IV) administration~Cisplatin: 30 mg/m² by intravenous (IV) administration~Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV~Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration"
11074250|NCT01437449|OG000|Outcome|Cisplatin + Docetaxel + Cetuximab|"Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.~Docetaxel: 30 mg/m² by intravenous (IV) administration~Cisplatin: 30 mg/m² by intravenous (IV) administration~Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV~Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration"
11074251|NCT01437449|EG000|Reported Event|Cisplatin + Docetaxel + Cetuximab|"Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.~Docetaxel: 30 mg/m² by intravenous (IV) administration~Cisplatin: 30 mg/m² by intravenous (IV) administration~Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV~Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration"
11074252|NCT01437488|BG000|Baseline|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy~Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
11074253|NCT01437488|FG000|Participant Flow|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
11074254|NCT01437488|OG000|Outcome|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
11173564|NCT02016300|EG000|Reported Event|Unloader Bracing|This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
11173565|NCT02016300|EG001|Reported Event|Non-Bracing Arm|This group was randomly selected and assigned to wear no brace post-operatively.
11173566|NCT02016482|BG000|Baseline|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11074255|NCT01437488|OG000|Outcome|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
11074256|NCT01437488|OG000|Outcome|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
11074257|NCT01437488|OG000|Outcome|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy~Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile."
11074258|NCT01437488|EG000|Reported Event|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
11074259|NCT01437501|BG000|Baseline|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
11074260|NCT01437501|BG001|Baseline|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
11074261|NCT01437501|BG002|Baseline|Total|Total of all reporting groups
11074262|NCT01437501|FG000|Participant Flow|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
11074263|NCT01437501|FG001|Participant Flow|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
11074264|NCT01437501|OG000|Outcome|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
11074265|NCT01437501|OG001|Outcome|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
11074266|NCT01437501|OG000|Outcome|Placebo Beverage|placebo beverage: 100 mL of dilute pineapple and lime juice daily for 84 days.
11074267|NCT01437501|OG001|Outcome|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage: Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
11074268|NCT01437501|EG000|Reported Event|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
11074269|NCT01437501|EG001|Reported Event|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
11074270|NCT01437540|BG000|Baseline|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
11074271|NCT01437540|BG001|Baseline|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
11074272|NCT01437540|BG002|Baseline|Total|Total of all reporting groups
11074273|NCT01437540|FG000|Participant Flow|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
11074274|NCT01437540|FG001|Participant Flow|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
11074275|NCT01437540|OG000|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
11074276|NCT01437540|OG001|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
11074277|NCT01437540|EG000|Reported Event|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
11074278|NCT01437540|EG001|Reported Event|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
11074279|NCT01437605|BG000|Baseline|A: recMAGE-A3 + AS15|"ASCI injections without Poly IC:LC~MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description"
11074280|NCT01437605|BG001|Baseline|B: recMAGE-A3 + AS15 + Poly IC:LC|"ASCI injections with Poly IC:LC~MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description"
11074281|NCT01437605|BG002|Baseline|Total|Total of all reporting groups
11074282|NCT01437605|FG000|Participant Flow|A: recMAGE-A3 + AS15|"ASCI injections without Poly IC:LC~MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description"
11074283|NCT01437605|FG001|Participant Flow|B: recMAGE-A3 + AS15 + Poly IC:LC|"ASCI injections with Poly IC:LC~MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description"
11074284|NCT01437605|OG000|Outcome|A: recMAGE-A3 + AS15|"ASCI injections without Poly IC:LC~MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description"
11074285|NCT01437605|OG001|Outcome|B: recMAGE-A3 + AS15 + Poly IC:LC|"ASCI injections with Poly IC:LC~MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description"
11074286|NCT01437605|EG000|Reported Event|A: recMAGE-A3 + AS15|"ASCI injections without Poly IC:LC~MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description"
11074287|NCT01437605|EG001|Reported Event|B: recMAGE-A3 + AS15 + Poly IC:LC|"ASCI injections with Poly IC:LC~MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description"
11074288|NCT01437852|BG000|Baseline|StrataGraft Skin Tissue : Autograft|Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
11074289|NCT01437852|FG000|Participant Flow|StrataGraft Skin Tissue : Autograft|Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
11074290|NCT01437852|OG000|Outcome|StrataGraft Skin Tissue|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
11074291|NCT01437852|OG001|Outcome|Autograft|The current standard of care for the management of severe burns and other skin trauma is excision of the necrotic tissue followed by autografting.
11074292|NCT01437852|EG000|Reported Event|StrataGraft Skin Tissue : Autograft|Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
11074293|NCT01437878|BG000|Baseline|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
11074294|NCT01437878|BG001|Baseline|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
11074295|NCT01437878|BG002|Baseline|Total|Total of all reporting groups
11074296|NCT01437878|FG000|Participant Flow|Iloprost|"single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
11074297|NCT01437878|FG001|Participant Flow|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
11074298|NCT01437878|OG000|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
11074299|NCT01437878|OG001|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
11074300|NCT01437878|EG000|Reported Event|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
11074301|NCT01437878|EG001|Reported Event|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
11074302|NCT01437943|BG000|Baseline|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
11074303|NCT01437943|BG001|Baseline|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet (0 mg) daily for 180 days"
11074304|NCT01437943|BG002|Baseline|Total|Total of all reporting groups
11074305|NCT01437943|FG000|Participant Flow|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
11074306|NCT01437943|FG001|Participant Flow|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet by mouth daily for 180 days"
11074307|NCT01437943|OG000|Outcome|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
11074308|NCT01437943|OG001|Outcome|Placebo|"Placebo identical to Aliskiren drug daily for 180 days~Placebo: Take 1 tablet (0 mg) daily for 180 days."
11074309|NCT01437943|EG000|Reported Event|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
11074310|NCT01437943|EG001|Reported Event|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet by mouth daily for 180 days"
11074311|NCT01437995|BG000|Baseline|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
11074312|NCT01437995|BG001|Baseline|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
11074313|NCT01437995|BG002|Baseline|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
11074314|NCT01437995|BG003|Baseline|Total|Total of all reporting groups
11074315|NCT01437995|FG000|Participant Flow|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
11074316|NCT01437995|FG001|Participant Flow|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
11074317|NCT01437995|FG002|Participant Flow|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
11074318|NCT01437995|OG000|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
11074319|NCT01437995|OG001|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
11074320|NCT01437995|OG002|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
11074321|NCT01437995|EG000|Reported Event|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
11074322|NCT01437995|EG001|Reported Event|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
11074323|NCT01437995|EG002|Reported Event|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
11074324|NCT01438008|BG000|Baseline|Sucrose 24% po|"24% sucrose solution. The CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum dose of 1 mL of a 24% sucrose solution~24% sucrose po solution: CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of a 24% sucrose solution. The maximum amount of the study solution will be administered according to the infant's gestational age and according to the hospital's Sucrose policy. The total amount of the study solution will be divided into a maximum of 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure."
11074325|NCT01438008|BG001|Baseline|Placebo po|"The CHEO pharmacy department will provide a syringe labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (contents almost identical in color, consistency and odor to the sucrose solution) in identical packagings~Placebo po: CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (almost identical in color, consistency and odor placebo to the sucrose solution in identical packaging) The total amount of the study solution will be divided into 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure"
11349090|NCT04123665|BG000|Baseline|Experimental Test Stannous Fluoride Dentifrice|In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight [w/w] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
11074326|NCT01438008|BG002|Baseline|Total|Total of all reporting groups
11074327|NCT01438008|FG000|Participant Flow|Sucrose 24% po|"24% sucrose solution. The CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum dose of 1 mL of a 24% sucrose solution~24% sucrose po solution: CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of a 24% sucrose solution. The maximum amount of the study solution will be administered according to the infant's gestational age and according to the hospital's Sucrose policy. The total amount of the study solution will be divided into a maximum of 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure."
11074328|NCT01438008|FG001|Participant Flow|Placebo po|"The CHEO pharmacy department will provide a syringe labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (contents almost identical in color, consistency and odor to the sucrose solution) in identical packagings~Placebo po: CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (almost identical in color, consistency and odor placebo to the sucrose solution in identical packaging) The total amount of the study solution will be divided into 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure"
11074329|NCT01438008|OG000|Outcome|Sucrose 24% po|"24% sucrose solution. The CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum dose of 1 mL of a 24% sucrose solution~24% sucrose po solution: CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of a 24% sucrose solution. The maximum amount of the study solution will be administered according to the infant's gestational age and according to the hospital's Sucrose policy. The total amount of the study solution will be divided into a maximum of 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure."
11074330|NCT01438008|OG001|Outcome|Placebo po|"The CHEO pharmacy department will provide a syringe labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (contents almost identical in color, consistency and odor to the sucrose solution) in identical packagings~Placebo po: CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (almost identical in color, consistency and odor placebo to the sucrose solution in identical packaging) The total amount of the study solution will be divided into 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure"
11173567|NCT02016482|BG001|Baseline|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11173568|NCT02016482|BG002|Baseline|Total|Total of all reporting groups
11074331|NCT01438008|EG000|Reported Event|Sucrose 24% po|"24% sucrose solution. The CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum dose of 1 mL of a 24% sucrose solution~24% sucrose po solution: CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of a 24% sucrose solution. The maximum amount of the study solution will be administered according to the infant's gestational age and according to the hospital's Sucrose policy. The total amount of the study solution will be divided into a maximum of 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure."
11074332|NCT01438008|EG001|Reported Event|Placebo po|"The CHEO pharmacy department will provide a syringe labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (contents almost identical in color, consistency and odor to the sucrose solution) in identical packagings~Placebo po: CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (almost identical in color, consistency and odor placebo to the sucrose solution in identical packaging) The total amount of the study solution will be divided into 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure"
11074333|NCT01438060|BG000|Baseline|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
11074334|NCT01438060|BG001|Baseline|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
11074335|NCT01438060|BG002|Baseline|Total|Total of all reporting groups
11074336|NCT01438060|FG000|Participant Flow|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
11074337|NCT01438060|FG001|Participant Flow|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
11074338|NCT01438060|OG000|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
11074339|NCT01438060|OG001|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
11074340|NCT01438060|OG000|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
11074341|NCT01438060|OG001|Outcome|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
11074342|NCT01438060|OG000|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
11074343|NCT01438060|OG000|Outcome|Aripiprazole|Treatment beyond 140 weeks: Dosed at 2-15 mg/day (flexible dosing).
11074344|NCT01438060|EG000|Reported Event|1 Double Blind Aripiprazole|
11074345|NCT01438060|EG001|Reported Event|2 Double Blind Placebo|
11074346|NCT01438060|EG002|Reported Event|3 Ext - Aripiprazole|
11074347|NCT01438151|BG000|Baseline|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
11074348|NCT01438151|FG000|Participant Flow|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
11074349|NCT01438151|OG000|Outcome|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
11074350|NCT01438151|EG000|Reported Event|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
11074351|NCT01438177|BG000|Baseline|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
11074352|NCT01438177|FG000|Participant Flow|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
11173569|NCT02016482|FG000|Participant Flow|Placebo|Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA) 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11150259|NCT01876732|FG000|Participant Flow|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
11150260|NCT01876732|OG000|Outcome|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
11150261|NCT01876732|OG000|Outcome|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
11150262|NCT01876732|EG000|Reported Event|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
11150263|NCT01876784|BG000|Baseline|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
11150264|NCT01876784|BG001|Baseline|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
11150265|NCT01876784|BG002|Baseline|Total|Total of all reporting groups
11150266|NCT01876784|FG000|Participant Flow|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
11150267|NCT01876784|FG001|Participant Flow|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
11150268|NCT01876784|OG000|Outcome|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
11150269|NCT01876784|OG001|Outcome|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
11150270|NCT01876784|EG000|Reported Event|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
11150271|NCT01876784|EG001|Reported Event|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
11150272|NCT01876810|BG000|Baseline|All Study Participants|"600 mg of gemfibrozil (one capsule) twice daily for two weeks.~Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks. or One lactose pill twice a day for two weeks."
11150273|NCT01876810|FG000|Participant Flow|Gemfibrozil/Placebo|Participants received 600 mg of gemfibrozil (one capsule) twice daily for two weeks. Then a washout period of 1 week of no medication. Then they received 1 capsule of placebo twice daily for 2 weeks
11150274|NCT01876810|FG001|Participant Flow|Placebo/Gemfibrozil|Participants received 1 capsule of placebo for 2 weeks. Then a washout period of 1 week of no medication. Then they received 600 mg of gemfibrozil (one capsule) twice daily for two weeks.
11150275|NCT01876810|OG000|Outcome|Gemfibrozil|Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period .
11150276|NCT01876810|OG001|Outcome|Placebo|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period.
11150277|NCT01876810|OG000|Outcome|Gemfibrozil|Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
11150278|NCT01876810|OG001|Outcome|Placebo Group|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
11150279|NCT01876810|OG000|Outcome|Gemfibrozil|Participants taking Gemfibrozil 600 mg (one capsule twice daily) for two weeks during the 1st phase of the study or during the second phase after the washout period.
11150280|NCT01876810|EG000|Reported Event|Gemfibrozil/Placebo|"600 mg of gemfibrozil (one capsule) twice daily for two weeks.~Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of placebo twice daily for 2 weeks"
11074353|NCT01438177|OG000|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
11074354|NCT01438177|EG000|Reported Event|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
11074355|NCT01438229|BG000|Baseline|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
11074356|NCT01438229|FG000|Participant Flow|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
11074357|NCT01438229|OG000|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
11074358|NCT01438229|EG000|Reported Event|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
11074359|NCT01438294|BG000|Baseline|Aerobic Exercise|"The aerobic training will be done on the treadmill with heart monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.~Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011)."
11074360|NCT01438294|BG001|Baseline|Video Game|"The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( reflex ridge- Adventure).~Video game group: The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure- reflex ridge)."
11074361|NCT01438294|BG002|Baseline|Total|Total of all reporting groups
11074362|NCT01438294|FG000|Participant Flow|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
11074363|NCT01438294|FG001|Participant Flow|Video Game|"The game Reflex Ridge of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA)."
11074364|NCT01438294|OG000|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
11074365|NCT01438294|OG001|Outcome|Video Game|"The game Reflex Ridge of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA)."
11074366|NCT01438294|EG000|Reported Event|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
11150281|NCT01876810|EG001|Reported Event|Placebo/Gemfibrozil|"One lactose pill twice a day for two weeks.~Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of gemfibrozil twice daily for 2 weeks"
11150282|NCT01876823|BG000|Baseline|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
11074367|NCT01438294|EG001|Reported Event|Video Game|"The game Reflex Ridge of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA)."
11074368|NCT01438307|BG000|Baseline|Schedule A|Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.
11074369|NCT01438307|BG001|Baseline|Schedule B|Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.
11074370|NCT01438307|BG002|Baseline|Total|Total of all reporting groups
11074371|NCT01438307|FG000|Participant Flow|Treatment Schedule A|"Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
11074372|NCT01438307|FG001|Participant Flow|Treatment Schedule B|"Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
11074373|NCT01438307|OG000|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
11074374|NCT01438307|OG001|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
11074375|NCT01438307|EG000|Reported Event|Treatment Schedule A|"Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
11074376|NCT01438307|EG001|Reported Event|Treatment Schedule B|"Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
11074377|NCT01438411|BG000|Baseline|Cholic Acid|Cholic acid capsules, each containing 50 mg or 250 mg of cholic acid to be administered orally at a daily dose of 10-15 mg/kg body weight
11074378|NCT01438411|FG000|Participant Flow|Cholic Acid|Cholic acid capsules, each containing 50 mg or 250 mg of cholic acid to be administered orally at a daily dose of 10-15 mg/kg body weight
11074379|NCT01438411|OG000|Outcome|Cholic Acid|Cholic acid capsules, each containing 50 mg or 250 mg of cholic acid to be administered orally at a daily dose of 10-15 mg/kg body weight
11074380|NCT01438411|EG000|Reported Event|Cholic Acid|"Active drug~Cholic Acid: 10-15 mg/kg body weight/day supplied in 50 or 250 mg Cholic Acid Capsules"
11074381|NCT01438424|BG000|Baseline|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
11074382|NCT01438424|FG000|Participant Flow|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
11074383|NCT01438424|OG000|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
11074384|NCT01438424|OG000|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
11074385|NCT01438424|OG000|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
11074386|NCT01438424|OG000|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
11074387|NCT01438424|EG000|Reported Event|Adefovir, 10 mg|Participants who received adefovir concomitantly at postdosing follow-up
11074388|NCT01438424|EG001|Reported Event|Entecavir, 0.02588 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
11074389|NCT01438424|EG002|Reported Event|Entecavir, 0.1 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
11074390|NCT01438424|EG003|Reported Event|Entecavir, 0.5 mg|Participants received entecavir QD with lamovidine
11074391|NCT01438424|EG004|Reported Event|Entecavir, 1.0 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
11074392|NCT01438424|EG005|Reported Event|Lamovidine, 100 mg|Participants originally received lamovidine with entecavir
11074393|NCT01438424|EG006|Reported Event|Missing|Category missing
11074394|NCT01438424|EG007|Reported Event|Placebo|Participants originally assigned to placebo before protocol change to study drug.
11091861|NCT01536496|EG001|Reported Event|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
11091862|NCT01536535|BG000|Baseline|Mild UC|Mild = Initiated on mesalamine, or on oral CS with PUCAI < 45
11091863|NCT01536535|BG001|Baseline|Moderate to Severe UC|Moderate/Severe = Initiated on IV CS, or oral CS with PUCAI ≥45
11150283|NCT01876823|FG000|Participant Flow|Es-citalopram and Memantine Treatment|This group received concurrent es-citalopram plus memantine treatment for 48 weeks. Patients ranged in age from 50-90 years old. Es-citalopram treatment began at 10mg per day for two weeks and was increased to 20mg per day for the 48 week duration. If a patient had an inadequate response to the antidepressant on two consecutive visits, the study physician used an alternative. At two weeks into the study, the patients were started on memantine 5mg, and the maximum dose of 20mg was reached by the six week point.
11150284|NCT01876823|OG000|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
11091864|NCT01536535|BG002|Baseline|Total|Total of all reporting groups
11091865|NCT01536535|FG000|Participant Flow|Mild UC Disease|Mild = Initiated on mesalazine, or on oral CS with Pediatric Ulcerative Colitis Activity Index (PUCAI) < 45
11091866|NCT01536535|FG001|Participant Flow|Moderate to Severe UC|Moderate/Severe = Initiated on IV CS, or oral CS with PUCAI ≥45
11091867|NCT01536535|OG000|Outcome|Mild UC|Mild = Initiated on mesalazine, or on oral CS with PUCAI < 45
11091868|NCT01536535|OG001|Outcome|Moderate to Severe UC|Moderate/Severe = Initiated on IV CS, or oral CS with PUCAI ≥45
11091869|NCT01536535|OG000|Outcome|Mild UC Disease|Mild = Initiated on mesalazine, or on oral CS with PUCAI < 45
11091870|NCT01536535|EG000|Reported Event|Mild UC|Mild = Initiated on 5-Aminosalicylates (ASA) or on oral CS with PUCAI < 45
11091871|NCT01536535|EG001|Reported Event|Moderate to Severe UC|Moderate/Severe = Initiated on IV CS or oral CS with PUCAI ≥45
11091872|NCT01536561|BG000|Baseline|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11091873|NCT01536561|FG000|Participant Flow|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11091874|NCT01536561|OG000|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11150285|NCT01876823|EG000|Reported Event|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
11173570|NCT02016482|FG001|Participant Flow|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11074395|NCT01438476|BG000|Baseline|TEA (Thoracic Epidural Analgesia)|"Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.~Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10."
11074396|NCT01438476|BG001|Baseline|IV-PCA (Intravenous Patient-controlled Analgesia)|"Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.~Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10."
11074397|NCT01438476|BG002|Baseline|Total|Total of all reporting groups
11074398|NCT01438476|FG000|Participant Flow|TEA (Thoracic Epidural Analgesia)|"Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.~Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10."
11074399|NCT01438476|FG001|Participant Flow|IV-PCA (Intravenous Patient-controlled Analgesia)|"Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.~Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10."
11074400|NCT01438476|OG000|Outcome|TEA (Thoracic Epidural Analgesia)|"Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.~Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10"
11074401|NCT01438476|OG001|Outcome|IV-PCA (Intravenous Patient-controlled Analgesia)|"Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.~Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10."
11074402|NCT01438476|EG000|Reported Event|TEA (Thoracic Epidural Analgesia)|"Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.~Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10."
11074403|NCT01438476|EG001|Reported Event|IV-PCA (Intravenous Patient-controlled Analgesia)|"Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.~Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.~Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10."
11074404|NCT01438489|BG000|Baseline|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
11074405|NCT01438489|BG001|Baseline|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074406|NCT01438489|BG002|Baseline|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074407|NCT01438489|BG003|Baseline|Total|Total of all reporting groups
11074408|NCT01438489|FG000|Participant Flow|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
11074409|NCT01438489|FG001|Participant Flow|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074410|NCT01438489|FG002|Participant Flow|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074411|NCT01438489|OG000|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
11074412|NCT01438489|OG001|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074413|NCT01438489|OG002|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074414|NCT01438489|OG000|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074415|NCT01438489|OG001|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074416|NCT01438489|EG000|Reported Event|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
11074417|NCT01438489|EG001|Reported Event|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074418|NCT01438489|EG002|Reported Event|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
11074419|NCT01438541|BG000|Baseline|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
11074420|NCT01438541|FG000|Participant Flow|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
11074421|NCT01438541|OG000|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
11074422|NCT01438541|EG000|Reported Event|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
11074423|NCT01438710|BG000|Baseline|Prograf|"Tacrolimus capsules for twice daily oral administration~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
11074424|NCT01438710|FG000|Participant Flow|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
11074425|NCT01438710|FG001|Participant Flow|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
11074426|NCT01438710|OG000|Outcome|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
11074427|NCT01438710|EG000|Reported Event|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
11074428|NCT01438710|EG001|Reported Event|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
11074429|NCT01438814|BG000|Baseline|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
11074430|NCT01438814|BG001|Baseline|Met Bid|Patients treated with metformin alone twice daily.
11074431|NCT01438814|BG002|Baseline|Total|Total of all reporting groups
11074432|NCT01438814|FG000|Participant Flow|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
11074433|NCT01438814|FG001|Participant Flow|Met Bid|Patients treated with metformin alone twice daily.
11074434|NCT01438814|OG000|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
11074435|NCT01438814|OG001|Outcome|Met Bid|Patients treated with metformin alone twice daily.
11074436|NCT01438814|EG000|Reported Event|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
11074437|NCT01438814|EG001|Reported Event|Met Bid|Patients treated with metformin alone twice daily.
11074438|NCT01438840|BG000|Baseline|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
11173571|NCT02016482|OG000|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11173572|NCT02016482|OG001|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11173573|NCT02016482|EG000|Reported Event|Placebo (Period A)|Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11173574|NCT02016482|EG001|Reported Event|Adalimumab EOW (Period A)|ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg.
11074439|NCT01438840|BG001|Baseline|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
11074440|NCT01438840|BG002|Baseline|Total|Total of all reporting groups
11074441|NCT01438840|FG000|Participant Flow|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
11074442|NCT01438840|FG001|Participant Flow|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
11074443|NCT01438840|FG002|Participant Flow|Avatrombopag (Extension Phase)|Participants who met all the eligibility criteria requirements of extension phase and who discontinued the core study because of lack of treatment effect continued into the extension phase. Avatrombopag was administered to participants who entered extension phase, with a starting dose of 20 mg avatrombopag, once daily for 76 weeks and underwent dose titration.
11074444|NCT01438840|OG000|Outcome|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
11074445|NCT01438840|OG001|Outcome|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
11074446|NCT01438840|EG000|Reported Event|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
11074447|NCT01438840|EG001|Reported Event|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
11074448|NCT01438840|EG002|Reported Event|Avatrombopag (Extension Phase)|Participants who met all eligibility criteria requirements of extension phase and who discontinued the core study because of lack of treatment effect continued into the extension phase. Avatrombopag was administered to participants who entered extension phase, with a starting dose of 20 mg avatrombopag, once daily for 76 weeks and underwent dose titration.
11074449|NCT01438957|BG000|Baseline|Placebo|0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
11074450|NCT01438957|BG001|Baseline|Dexmedetomidine 0.067 mcg/kg|0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074451|NCT01438957|BG002|Baseline|Dexmedetomidine 0.25 mcg/kg|1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074452|NCT01438957|BG003|Baseline|Dexmedetomidine 0.5 mcg/kg|3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074453|NCT01438957|BG004|Baseline|Dexmedetomidine 1.0 mcg/kg|6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074454|NCT01438957|BG005|Baseline|Total|Total of all reporting groups
11074455|NCT01438957|FG000|Participant Flow|Placebo|0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
11074456|NCT01438957|FG001|Participant Flow|Dexmedetomidine 0.067 mcg/kg|0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074457|NCT01438957|FG002|Participant Flow|Dexmedetomidine 0.25 mcg/kg|1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074458|NCT01438957|FG003|Participant Flow|Dexmedetomidine 0.5 mcg/kg|3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074459|NCT01438957|FG004|Participant Flow|Dexmedetomidine 1.0 mcg/kg|6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074460|NCT01438957|OG000|Outcome|Placebo|0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
11074461|NCT01438957|OG001|Outcome|Dexmedetomidine 0.067 mcg/kg|0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074462|NCT01438957|OG002|Outcome|Dexmedetomidine 0.25 mcg/kg|1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074463|NCT01438957|OG003|Outcome|Dexmedetomidine 0.5 mcg/kg|3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074464|NCT01438957|OG004|Outcome|Dexmedetomidine 1.0 mcg/kg|6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074465|NCT01438957|EG000|Reported Event|Placebo|0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
11074466|NCT01438957|EG001|Reported Event|Dexmedetomidine 0.067 mcg/kg|0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074467|NCT01438957|EG002|Reported Event|Dexmedetomidine 0.25 mcg/kg|1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074468|NCT01438957|EG003|Reported Event|Dexmedetomidine 0.5 mcg/kg|3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074469|NCT01438957|EG004|Reported Event|Dexmedetomidine 1.0 mcg/kg|6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
11074470|NCT01438996|BG000|Baseline|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
11074471|NCT01438996|BG001|Baseline|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
11074472|NCT01438996|BG002|Baseline|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
11074473|NCT01438996|BG003|Baseline|Total|Total of all reporting groups
11074474|NCT01438996|FG000|Participant Flow|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
11074475|NCT01438996|FG001|Participant Flow|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
11074476|NCT01438996|FG002|Participant Flow|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
11074477|NCT01438996|OG000|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
11074478|NCT01438996|OG001|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
11074479|NCT01438996|OG002|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
11074480|NCT01438996|EG000|Reported Event|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
11074481|NCT01438996|EG001|Reported Event|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
11074482|NCT01438996|EG002|Reported Event|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
11074483|NCT01439009|BG000|Baseline|Tolvaptan|"15 mg~Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning"
11074484|NCT01439009|BG001|Baseline|Placebo|"Placebo~Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning"
11074485|NCT01439009|BG002|Baseline|Total|Total of all reporting groups
11074486|NCT01439009|FG000|Participant Flow|Tolvaptan|"15 mg~Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning"
11074487|NCT01439009|FG001|Participant Flow|Placebo|"Placebo~Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning"
11074488|NCT01439009|OG000|Outcome|Tolvaptan|"15 mg~Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning"
11074489|NCT01439009|OG001|Outcome|Placebo|"Placebo~Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning"
11074490|NCT01439009|EG000|Reported Event|Tolvaptan|"15 mg~Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning"
11074491|NCT01439009|EG001|Reported Event|Placebo|"Placebo~Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning"
11074492|NCT01439035|BG000|Baseline|MGH OFDI Imaging|"OFDI imaging~MGH OFDI Imaging: Imaging of Duodenum with OFDI system"
11074493|NCT01439035|FG000|Participant Flow|MGH OFDI Imaging|"OFDI imaging~MGH OFDI Imaging: Imaging of Duodenum with OFDI system"
11074494|NCT01439035|OG000|Outcome|Compare OFDI Images to Histologic|compare OFDI images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease
11074495|NCT01439035|EG000|Reported Event|MGH OFDI Imaging|"OFDI imaging~MGH OFDI Imaging: Imaging of Duodenum with OFDI system"
11074496|NCT01439074|BG000|Baseline|Mepilex Ag|"Mepilex Ag consists of a Safetac® soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
11074497|NCT01439074|BG001|Baseline|SSD Ag Cream|"Silver Sulphadiazine Ag white cream, 1% SSD Ag, 40g/tube~Silver sulphadiazine: Cream"
11074498|NCT01439074|BG002|Baseline|Total|Total of all reporting groups
11074499|NCT01439074|FG000|Participant Flow|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
11074500|NCT01439074|FG001|Participant Flow|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
11074501|NCT01439074|OG000|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
11074502|NCT01439074|OG001|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
11074503|NCT01439074|EG000|Reported Event|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
11074504|NCT01439074|EG001|Reported Event|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
11074505|NCT01439087|BG000|Baseline|OFDI Imaging|"OFDI imaging~MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system"
11074506|NCT01439087|FG000|Participant Flow|OFDI Imaging|"OFDI imaging~MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system"
11074507|NCT01439087|OG000|Outcome|Feasibility & Sensitivity of OFDI Imaging in the Colon|"Feasibility is measured by the number of enrolled subjects that met imaging eligibility criteria and were successfully imaged with the OFDI device.~Sensitivity is measured by the number of enrolled subjects that met eligibility criteria, and had a polyp(s) successfully imaged and identified by the OFDI device."
11074508|NCT01439087|EG000|Reported Event|OFDI Imaging|"OFDI imaging~MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system"
11074509|NCT01439126|BG000|Baseline|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
11074510|NCT01439126|BG001|Baseline|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
11074511|NCT01439126|BG002|Baseline|Total|Total of all reporting groups
11173575|NCT02016482|EG002|Reported Event|Placebo/Adalimumab EOW (Period B)|Following Period A (placebo sc eow for 25 weeks), ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11074512|NCT01439126|FG000|Participant Flow|Subjects on KAPVAY (Clonidine Hydrochloride)|"Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period.~All subjects were given study medication at the baseline visit (Visit 2, open label) and instructed to take 1 x 0.1 mg tablet each evening (Day 1) at bedtime until the next visit. Subjects who required an increase in total dose to 0.2 mg/day took 1 x 0.1 mg tablet (0.1 mg) in the morning and at bedtime until the next visit. Those who required a further increase in dose to 0.3 mg/day took 1 x 0.1 mg tablet in the morning and 2 x 0.1 mg tablets at bedtime until the next visit. Patient increasing dose to 0.4 mg/day were instructed to take 2 x 0.1 mg tablets in the morning and at bedtime until the next visit.~Of 68 Subjects randomized to KAPVAY:~24 (35.3%) oral dose of 0.4 mg/day 25 (36.8%) oral dose of 0.3 mg/day 14 (20.6%) oral dose of 0.2 mg/day 5 (7.4%) oral dose of 0.1 mg/day"
11074513|NCT01439126|FG001|Participant Flow|Subjects on Placebo|"Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study~Of 67 Subjects randomized to Placebo:~26 (38.8%) oral dose of 0.4 mg/day 24 (35.8%) oral dose of 0.3 mg/day 15 (22.4%) oral dose of 0.2 mg/day 2 (3.0%) oral dose of 0.1 mg/day"
11074514|NCT01439126|OG000|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
11074515|NCT01439126|OG001|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
11074516|NCT01439126|EG000|Reported Event|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
11074517|NCT01439126|EG001|Reported Event|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
11074518|NCT01439204|BG000|Baseline|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
11074519|NCT01439204|BG001|Baseline|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
11074520|NCT01439204|BG002|Baseline|Total|Total of all reporting groups
11074521|NCT01439204|FG000|Participant Flow|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
11074522|NCT01439204|FG001|Participant Flow|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
11074523|NCT01439204|OG000|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
11074524|NCT01439204|OG001|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
11074525|NCT01439204|EG000|Reported Event|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
11074526|NCT01439204|EG001|Reported Event|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
11074527|NCT01439282|BG000|Baseline|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11074528|NCT01439282|BG001|Baseline|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11074529|NCT01439282|BG002|Baseline|Total|Total of all reporting groups
11074530|NCT01439282|FG000|Participant Flow|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11173576|NCT02016482|EG003|Reported Event|Adalimumab EOW/Adalimumab EOW (Period B)|Following Period A (ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg), placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
11074531|NCT01439282|FG001|Participant Flow|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11074532|NCT01439282|OG000|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11074533|NCT01439282|OG001|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11074534|NCT01439282|OG000|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11074535|NCT01439282|EG000|Reported Event|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11074536|NCT01439282|EG001|Reported Event|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
11074537|NCT01439360|BG000|Baseline|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
11074538|NCT01439360|BG001|Baseline|Control|In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
11074539|NCT01439360|BG002|Baseline|Total|Total of all reporting groups
11074540|NCT01439360|FG000|Participant Flow|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
11074541|NCT01439360|FG001|Participant Flow|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
11074542|NCT01439360|OG000|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
11074543|NCT01439360|OG001|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
11074544|NCT01439360|EG000|Reported Event|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
11074545|NCT01439360|EG001|Reported Event|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
11074546|NCT01439373|BG000|Baseline|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
11074547|NCT01439373|BG001|Baseline|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
11074548|NCT01439373|BG002|Baseline|Total|Total of all reporting groups
11074549|NCT01439373|FG000|Participant Flow|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 milligram (mg) orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with peginterferon alfa-2a (PEG) 180 microgram (mcg) per week as subcutaneous injection (SC) and ribavirin (RIBA) 1000 mg (if <75 kilogram [kg]) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
11173577|NCT02016560|BG000|Baseline|Exploratory Young Cognitively Healthy Subjects|Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29
11074550|NCT01439373|FG001|Participant Flow|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
11074551|NCT01439373|OG000|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
11074552|NCT01439373|OG001|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
11074553|NCT01439373|OG000|Outcome|GSK2336805 60 mg (Part A)|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study.
11074554|NCT01439373|OG001|Outcome|Placebo (Part A)|Eligible participants received matching placebo once daily on Day 1 (Part A) of the study
11074555|NCT01439373|OG000|Outcome|GSK2336805 60 mg (Part A)|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study
11074556|NCT01439373|OG000|Outcome|GSK2336805 60 mg|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study
11074557|NCT01439373|EG000|Reported Event|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
11074558|NCT01439373|EG001|Reported Event|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
11074559|NCT01439555|BG000|Baseline|Simvastatin + L-Arginine + Tetrahydrobiopterin|"Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally; Tetrahydrobiopterin 20 mg/kg/day orally~Simvastatin: Simvastatin, 40 mg per day orally~L-Arginine: L-Arginine, 2 Gm four times per day orally;~Tetrahydrobiopterin: Tetrahydrobiopterin 20 mg/kg/day orally"
11074560|NCT01439555|FG000|Participant Flow|Simvastatin + L-Arginine + Tetrahydrobiopterin|"Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally; Tetrahydrobiopterin 20 mg/kg/day orally~Simvastatin: Simvastatin, 40 mg per day orally~L-Arginine: L-Arginine, 2 Gm four times per day orally;~Tetrahydrobiopterin: Tetrahydrobiopterin 20 mg/kg/day orally"
11074561|NCT01439555|OG000|Outcome|Simvastatin + L-Arginine + Tetrahydrobiopterin|"Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally; Tetrahydrobiopterin 20 mg/kg/day orally~Simvastatin: Simvastatin, 40 mg per day orally~L-Arginine: L-Arginine, 2 Gm four times per day orally;~Tetrahydrobiopterin: Tetrahydrobiopterin 20 mg/kg/day orally"
11074562|NCT01439555|EG000|Reported Event|Simvastatin + L-Arginine + Tetrahydrobiopterin|"Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally; Tetrahydrobiopterin 20 mg/kg/day orally~Simvastatin: Simvastatin, 40 mg per day orally~L-Arginine: L-Arginine, 2 Gm four times per day orally;~Tetrahydrobiopterin: Tetrahydrobiopterin 20 mg/kg/day orally"
11074563|NCT01439568|BG000|Baseline|LY2510924 + Carboplatin + Etoposide|LY2510924: 20 milligram (mg) administered once daily as a subcutaneous injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
11074564|NCT01439568|BG001|Baseline|Carboplatin + Etoposide|Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
11074565|NCT01439568|BG002|Baseline|Total|Total of all reporting groups
11074566|NCT01439568|FG000|Participant Flow|LY2510924 + Carboplatin + Etoposide|LY2510924: 20 milligram (mg) administered once daily as a subcutaneous injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
11074567|NCT01439568|FG001|Participant Flow|Carboplatin + Etoposide|Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
11074568|NCT01439568|OG000|Outcome|LY2510924 + Carboplatin + Etoposide|LY2510924: 20 milligram (mg) administered once daily as a subcutaneous injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
11074569|NCT01439568|OG001|Outcome|Carboplatin + Etoposide|Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
11074570|NCT01439568|EG000|Reported Event|LY2510924 + Carboplatin + Etoposide|LY2510924: 20 milligram (mg) administered once daily as a subcutaneous injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
11074571|NCT01439568|EG001|Reported Event|Carboplatin + Etoposide|Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
11074572|NCT01439581|BG000|Baseline|Patients on Mapping Systems|Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
11074573|NCT01439581|BG001|Baseline|Patients Not on Mapping Systems|Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
11074574|NCT01439581|BG002|Baseline|Total|Total of all reporting groups
11074575|NCT01439581|FG000|Participant Flow|Patients on Mapping Systems|Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
11074576|NCT01439581|FG001|Participant Flow|Patients Not on Mapping Systems|Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
11074577|NCT01439581|OG000|Outcome|Patients on Mapping Systems|Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
11074578|NCT01439581|OG001|Outcome|Patients Not on Mapping Systems|Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
11074579|NCT01439581|EG000|Reported Event|Patients on Mapping Systems|Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
11074580|NCT01439581|EG001|Reported Event|Patients Not on Mapping Systems|Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
11074581|NCT01439594|BG000|Baseline|MGH OFDI Imaging|"OFDI imaging~MGH OFDI Imaging: Imaging of Esophagus with OFDI system"
11074582|NCT01439594|FG000|Participant Flow|MGH OFDI Imaging|"OFDI imaging~MGH OFDI Imaging: Imaging of Esophagus with OFDI system"
11074583|NCT01439594|OG000|Outcome|Feasibility|Total number of imaging sessions conducted
11074584|NCT01439594|EG000|Reported Event|MGH OFDI Imaging|"OFDI imaging~MGH OFDI Imaging: Imaging of Esophagus with OFDI system"
11074585|NCT01439620|BG000|Baseline|OFDI Imaging|"Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.~MGH Optical Frequency Domain Imaging (OFDI): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System"
11074586|NCT01439620|FG000|Participant Flow|OFDI Imaging|"Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.~MGH Optical Frequency Domain Imaging (OFDI): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System"
11074587|NCT01439620|OG000|Outcome|Optical Frequency Domain Imaging (OFDI Imaging|"Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.~MGH Optical Frequency Domain Imaging (OFDI): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System"
11074588|NCT01439620|EG000|Reported Event|OFDI Imaging|"Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.~MGH Optical Frequency Domain Imaging (OFDI): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System"
11074589|NCT01439633|BG000|Baseline|MGH OFDI Marking and Imaging|"OFDI imaging~MGH OFDI marking: Imaging of esophagus with OFDI system"
11074590|NCT01439633|FG000|Participant Flow|MGH OFDI Marking and Imaging|"OFDI imaging~MGH OFDI marking: Imaging of esophagus with OFDI system"
11074591|NCT01439633|OG000|Outcome|MGH OFDI Marking and Imaging|"OFDI imaging~MGH OFDI marking: Imaging of esophagus with OFDI system"
11074592|NCT01439633|EG000|Reported Event|MGH OFDI Marking and Imaging|"OFDI imaging~MGH OFDI marking: Imaging of esophagus with OFDI system"
11074593|NCT01439672|BG000|Baseline|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
11074594|NCT01439672|FG000|Participant Flow|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
11173578|NCT02016560|BG001|Baseline|Exploratory Older Cognitively Healthy Subjects|Male or female subjects ≥50 years of age with MMSE ≥29
11074595|NCT01439672|OG000|Outcome|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. Each subject will be admitted twice approximately 3 weeks apart.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
11074596|NCT01439672|EG000|Reported Event|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
11074597|NCT01439711|BG000|Baseline|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
11074598|NCT01439711|FG000|Participant Flow|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
11074599|NCT01439711|OG000|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
11074600|NCT01439711|EG000|Reported Event|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
11074601|NCT01439724|BG000|Baseline|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
11074602|NCT01439724|BG001|Baseline|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
11074603|NCT01439724|BG002|Baseline|Total|Total of all reporting groups
11074604|NCT01439724|FG000|Participant Flow|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
11074605|NCT01439724|FG001|Participant Flow|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4 Joules(J)/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
11074606|NCT01439724|OG000|Outcome|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
11074607|NCT01439724|OG001|Outcome|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
11173579|NCT02016560|BG002|Baseline|Exploratory MCI Subjects|Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24
11074608|NCT01439724|EG000|Reported Event|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
11074609|NCT01439724|EG001|Reported Event|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
11074610|NCT01439815|BG000|Baseline|Fluticasone Propionate Nasal Spray|Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
11074611|NCT01439815|BG001|Baseline|Placebo Nasal Spray|Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
11074612|NCT01439815|BG002|Baseline|Total|Total of all reporting groups
11074613|NCT01439815|FG000|Participant Flow|Fluticasone Propionate Nasal Spray|Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
11074614|NCT01439815|FG001|Participant Flow|Placebo Nasal Spray|Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
11074615|NCT01439815|OG000|Outcome|Fluticasone Propionate Nasal Spray|Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
11074616|NCT01439815|OG001|Outcome|Placebo Nasal Spray|Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
11074617|NCT01439815|EG000|Reported Event|Fluticasone Propionate Nasal Spray|Two sprays in each nostril daily starting the day after Day 1 for up to 14 days.
11074618|NCT01439815|EG001|Reported Event|Placebo Nasal Spray|Two sprays in each nostril daily starting the day after Day 1 for up to 14 days.
11074619|NCT01439854|BG000|Baseline|Placebo|"this arm is control~Placebo: Patients are treated with placebo"
11074620|NCT01439854|BG001|Baseline|Dapagliflozin|"Interventional arm~Dapagliflozin: Treatment arm, 10 mg per day for 2 weeks"
11074621|NCT01439854|BG002|Baseline|Total|Total of all reporting groups
11074622|NCT01439854|FG000|Participant Flow|Placebo|"this arm is control~Placebo: Patients are treated with placebo"
11074623|NCT01439854|FG001|Participant Flow|Dapagliflozin|"Interventional arm~Dapagliflozin: Treatment arm, 10 mg per day for 2 weeks"
11074624|NCT01439854|OG000|Outcome|Placebo|"this arm is control~Placebo: Patients are treated with placebo"
11074625|NCT01439854|OG001|Outcome|Dapagliflozin|"Interventional arm~Dapagliflozin: Treatment arm, 10 mg per day for 2 weeks"
11074626|NCT01439854|EG000|Reported Event|Placebo|"this arm is control~Placebo: Patients are treated with placebo"
11074627|NCT01439854|EG001|Reported Event|Dapagliflozin|"Interventional arm~Dapagliflozin: Treatment arm, 10 mg per day for 2 weeks"
11074628|NCT01439867|BG000|Baseline|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
11074629|NCT01439867|BG001|Baseline|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
11074630|NCT01439867|BG002|Baseline|Total|Total of all reporting groups
11074631|NCT01439867|FG000|Participant Flow|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
11074632|NCT01439867|FG001|Participant Flow|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
11074633|NCT01439867|OG000|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
11074634|NCT01439867|OG001|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
11074635|NCT01439867|OG002|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
11173580|NCT02016560|BG003|Baseline|Exploratory AD Subjects|Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE >10
11074636|NCT01439867|EG000|Reported Event|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
11074637|NCT01439867|EG001|Reported Event|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
11074638|NCT01439867|EG002|Reported Event|Total|Participants received cinacalcet administered daily for 24 weeks.
11074639|NCT01439880|BG000|Baseline|Standard of Care|Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
11074640|NCT01439880|BG001|Baseline|Evolocumab + SOC|Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
11074641|NCT01439880|BG002|Baseline|Total|Total of all reporting groups
11074642|NCT01439880|FG000|Participant Flow|Standard of Care|"Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).~At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years in the all-investigational product [all-IP] period."
11074643|NCT01439880|FG001|Participant Flow|Evolocumab + SOC|"Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).~At week 52 participants continued treatment with evolocumab 420 mg QM for up to 4 years in the all-IP period."
11074644|NCT01439880|OG000|Outcome|SOC-controlled Period: Standard of Care|Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
11074645|NCT01439880|OG001|Outcome|SOC-controlled Period: Evolocumab + SOC|Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
11074646|NCT01439880|OG002|Outcome|All-IP Period: SOC / Evolocumab + SOC|At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.
11074647|NCT01439880|OG003|Outcome|All-IP Period: Evolocumab + SOC / Evolocumab + SOC|At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.
11074648|NCT01439880|OG000|Outcome|Standard of Care|Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
11074649|NCT01439880|OG001|Outcome|Evolocumab + SOC|Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
11074650|NCT01439880|OG002|Outcome|Control in Parent Study: SOC|Participants who received a control treatment in the parent study received standard of care treatment for the first year of the extension study.
11074651|NCT01439880|OG003|Outcome|Control in Parent Study: Evolocumab + SOC|Participants who received a control treatment in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.
11074652|NCT01439880|OG004|Outcome|Evolocumab in Parent Study: SOC|Participants who received evolocumab in the parent study received standard of care treatment during the first year of the extension study.
11173581|NCT02016560|BG004|Baseline|Confirmatory Subjects MCI|Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
11074653|NCT01439880|OG005|Outcome|Evolocumab in Parent Study: Evolocumab + SOC|Participants who received evolocumab in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.
11074654|NCT01439880|EG000|Reported Event|SOC-controlled Period: SOC|Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).
11074655|NCT01439880|EG001|Reported Event|SOC-controlled Period: Evolocumab + SOC|Participants received evolocumab 420 mg once a month for the first year of the study (SOC-controlled period).
11074656|NCT01439880|EG002|Reported Event|All-IP Period: SOC / Evolocumab|At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.
11074657|NCT01439880|EG003|Reported Event|All-IP Period: Evolocumab + SOC / Evolocumab|At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.
11074658|NCT01439880|EG004|Reported Event|All-IP Period: Total|All participants in the All-IP period who received evolocumab 420 mg QM for up to 4 years.
11074659|NCT01439945|BG000|Baseline|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074660|NCT01439945|BG001|Baseline|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074661|NCT01439945|BG002|Baseline|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
11074662|NCT01439945|BG003|Baseline|Total|Total of all reporting groups
11074663|NCT01439945|FG000|Participant Flow|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074664|NCT01439945|FG001|Participant Flow|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074665|NCT01439945|FG002|Participant Flow|Low Dose Placebo|"Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two placebo tablets daily (QD)."
11074666|NCT01439945|FG003|Participant Flow|High Dose Placebo|"Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take three placebo tablets daily (QD)."
11074667|NCT01439945|OG000|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074668|NCT01439945|OG001|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074669|NCT01439945|OG002|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
11074670|NCT01439945|OG000|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074671|NCT01439945|OG001|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
11074672|NCT01439945|EG000|Reported Event|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074673|NCT01439945|EG001|Reported Event|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
11074674|NCT01439945|EG002|Reported Event|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
11074675|NCT01439945|EG003|Reported Event|Optional Continuation Phase|After the double blind phase patient questionnaire booklet has been completed and returned to the investigator, the patient will be told whether she was on magnesium or placebo. If the patient wishes to continue or start the magnesium, and healthcare provider approves that this is an appropriate option, she may be registered on the Optional Continuation Phase of the study. This phase will last up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.
11074676|NCT01439971|BG000|Baseline|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
11074677|NCT01439971|BG001|Baseline|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074678|NCT01439971|BG002|Baseline|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074679|NCT01439971|BG003|Baseline|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074680|NCT01439971|BG004|Baseline|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074681|NCT01439971|BG005|Baseline|Total|Total of all reporting groups
11074682|NCT01439971|FG000|Participant Flow|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
11074683|NCT01439971|FG001|Participant Flow|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074684|NCT01439971|FG002|Participant Flow|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074685|NCT01439971|FG003|Participant Flow|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074686|NCT01439971|FG004|Participant Flow|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074687|NCT01439971|OG000|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
11074688|NCT01439971|OG001|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074689|NCT01439971|OG002|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074690|NCT01439971|OG003|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074691|NCT01439971|OG004|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074692|NCT01439971|EG000|Reported Event|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
11074693|NCT01439971|EG001|Reported Event|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074694|NCT01439971|EG002|Reported Event|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074695|NCT01439971|EG003|Reported Event|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074696|NCT01439971|EG004|Reported Event|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
11074697|NCT01440049|BG000|Baseline|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
11074698|NCT01440049|FG000|Participant Flow|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
11074699|NCT01440049|OG000|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
11074700|NCT01440049|EG000|Reported Event|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
11074701|NCT01440101|BG000|Baseline|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074702|NCT01440101|BG001|Baseline|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
11074703|NCT01440101|BG002|Baseline|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074704|NCT01440101|BG003|Baseline|Total|Total of all reporting groups
11074705|NCT01440101|FG000|Participant Flow|Open Label Natalizumab|300 mg intravenous (IV) infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074706|NCT01440101|FG001|Participant Flow|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
11074707|NCT01440101|FG002|Participant Flow|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074708|NCT01440101|OG000|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074709|NCT01440101|OG000|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
11074710|NCT01440101|OG001|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074711|NCT01440101|OG000|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074712|NCT01440101|EG000|Reported Event|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074713|NCT01440101|EG001|Reported Event|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
11074714|NCT01440101|EG002|Reported Event|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
11074715|NCT01440283|BG000|Baseline|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
11074716|NCT01440283|FG000|Participant Flow|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
11074717|NCT01440283|OG000|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
11074718|NCT01440283|OG000|Outcome|Right Kidney: M-L|Nine participants who underwent all 3 scans.
11074719|NCT01440283|OG001|Outcome|Right Kidney: A-P|Nine participants who underwent all 3 scans.
11074720|NCT01440283|OG002|Outcome|Right Kidney: S-I|Nine participants who underwent all 3 scans.
11074721|NCT01440283|OG003|Outcome|Left Kidney: M-L|Nine participants who underwent all 3 scans.
11074722|NCT01440283|OG004|Outcome|Left Kidney: A-P|Nine participants who underwent all 3 scans.
11074723|NCT01440283|OG005|Outcome|Left Kidney: S-I|Nine participants who underwent all 3 scans.
11173582|NCT02016560|BG005|Baseline|Confirmatory Subjects AD|Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
11173583|NCT02016560|BG006|Baseline|Total|Total of all reporting groups
11173584|NCT02016560|FG000|Participant Flow|Exploratory Young Cognitively Healthy Subjects|Male or female subjects ≥20 to ≤40 years of age with mini-mental status exam (MMSE) score ≥29
11173585|NCT02016560|FG001|Participant Flow|Exploratory Older Cognitively Healthy Subjects|Male or female subjects ≥50 years of age with MMSE Score ≥29
11074724|NCT01440283|EG000|Reported Event|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
11074725|NCT01440322|BG000|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
11074726|NCT01440322|BG001|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
11074727|NCT01440322|BG002|Baseline|Total|Total of all reporting groups
11074728|NCT01440322|FG000|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
11074729|NCT01440322|FG001|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
11074730|NCT01440322|OG000|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
11074731|NCT01440322|OG001|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
11074732|NCT01440322|EG000|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
11074733|NCT01440322|EG001|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
11074734|NCT01440374|BG000|Baseline|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
11074735|NCT01440374|BG001|Baseline|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
11074736|NCT01440374|BG002|Baseline|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
11074737|NCT01440374|BG003|Baseline|Total|Total of all reporting groups
11227376|NCT02382913|BG005|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11074738|NCT01440374|FG000|Participant Flow|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 milligrams (mg) daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
11074739|NCT01440374|FG001|Participant Flow|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
11074740|NCT01440374|FG002|Participant Flow|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
11074741|NCT01440374|FG003|Participant Flow|Part 3: Eltrombopag|"23 subjects of the 47 randomized to the placebo group in Part 2 entered part 3. 36 subjects of the 98 randomized to the Etrombopag group in Part 2 entered part 3.~All subjects received eltrombopag. Part 3 subjects could also have received treatment for their disease per local SOC, including azacitidine, decitabine, lenalidomide, and chemotherapy. The duration of Part 3 was to be 10 months for subjects from Part 1and 9 months for subjects from Part 2."
11074742|NCT01440374|OG000|Outcome|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
11074743|NCT01440374|OG000|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
11227377|NCT02382913|BG006|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11074744|NCT01440374|OG001|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
11074745|NCT01440374|OG000|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
11074746|NCT01440374|OG000|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
11074747|NCT01440374|OG001|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
11074748|NCT01440374|EG000|Reported Event|Eltrombopag, Part 1 Subjects|Eltrombopag, Part 1 subjects
11074749|NCT01440374|EG001|Reported Event|Eltrombopag, Part 2 Plus 1 Day From Part 2 Subjects|Eltrombopag, Part 2 plus 1 day from Part 2 subjects
11074750|NCT01440374|EG002|Reported Event|Placebo, Part 2 Plus 1 Day From Part 2 Subjects|Placebo, Part 2 plus 1 day from Part 2 subjects
11074751|NCT01440374|EG003|Reported Event|Eltrombopag, Part 3 Plus 30 Days From Part 2 Subjects|Eltrombopag, Part 3 plus 30 Days from Part 2 subjects
11074752|NCT01440387|BG000|Baseline|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11074753|NCT01440387|BG001|Baseline|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11074754|NCT01440387|BG002|Baseline|Total|Total of all reporting groups
11074755|NCT01440387|FG000|Participant Flow|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11074756|NCT01440387|FG001|Participant Flow|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11074757|NCT01440387|OG000|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11074758|NCT01440387|OG001|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11074759|NCT01440387|EG000|Reported Event|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11074760|NCT01440387|EG001|Reported Event|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11074761|NCT01440543|BG000|Baseline|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
11074762|NCT01440543|BG001|Baseline|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
11074763|NCT01440543|BG002|Baseline|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
11074764|NCT01440543|BG003|Baseline|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
11074765|NCT01440543|BG004|Baseline|Total|Total of all reporting groups
11074766|NCT01440543|FG000|Participant Flow|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
11074767|NCT01440543|FG001|Participant Flow|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
11074768|NCT01440543|FG002|Participant Flow|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
11074769|NCT01440543|FG003|Participant Flow|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
11074770|NCT01440543|OG000|Outcome|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
11074771|NCT01440543|OG001|Outcome|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
11074772|NCT01440543|OG002|Outcome|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
11074773|NCT01440543|OG003|Outcome|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
11074774|NCT01440543|EG000|Reported Event|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
11074775|NCT01440543|EG001|Reported Event|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
11074776|NCT01440543|EG002|Reported Event|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
11074777|NCT01440543|EG003|Reported Event|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
11074778|NCT01440569|BG000|Baseline|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
11074779|NCT01440569|BG001|Baseline|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
11074780|NCT01440569|BG002|Baseline|Total|Total of all reporting groups
11074781|NCT01440569|FG000|Participant Flow|Treatment-Naive|Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
11074782|NCT01440569|FG001|Participant Flow|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
11074783|NCT01440569|OG000|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
11074784|NCT01440569|OG001|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
11074785|NCT01440569|EG000|Reported Event|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
11074786|NCT01440569|EG001|Reported Event|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
11074787|NCT01440634|BG000|Baseline|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
11074788|NCT01440634|BG001|Baseline|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
11074789|NCT01440634|BG002|Baseline|Total|Total of all reporting groups
11074790|NCT01440634|FG000|Participant Flow|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
11074791|NCT01440634|FG001|Participant Flow|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
11074792|NCT01440634|OG000|Outcome|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
11074793|NCT01440634|OG001|Outcome|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
11074794|NCT01440634|EG000|Reported Event|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
11074795|NCT01440634|EG001|Reported Event|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
11074796|NCT01440647|BG000|Baseline|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
11074797|NCT01440647|BG001|Baseline|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
11074798|NCT01440647|BG002|Baseline|Total|Total of all reporting groups
11074799|NCT01440647|FG000|Participant Flow|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
11074800|NCT01440647|FG001|Participant Flow|CPAP|After extubation this arm was placed on CPAP (continuous positive airway pressure)and was not offered NIPPV in the first month on life
11074801|NCT01440647|OG000|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
11074802|NCT01440647|OG001|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
11074803|NCT01440647|EG000|Reported Event|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
11074804|NCT01440647|EG001|Reported Event|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
11074805|NCT01440764|BG000|Baseline|F(40) Participants|Participants who consented to participate in the study and receive the Aerosol Furosemide (40mg/4ml solution of Saline), Aerosol Saline (4ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
11074806|NCT01440764|BG001|Baseline|F(80) Participants|Participants who consented to participate in the study and receive the Aerosol Furosemide (80mg/8ml solution of Saline) and two Aerosol Saline (8ml) Interventions in any sequence or receive the Aerosol Furosemide (80mg/8ml solution of Saline), Aerosol Saline (8ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
11074807|NCT01440764|BG002|Baseline|Total|Total of all reporting groups
11074808|NCT01440764|FG000|Participant Flow|F(40), Then Saline, Then IV.F|"On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
11074809|NCT01440764|FG001|Participant Flow|IV.F, Then F(40), Then Saline|"On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes."
11074810|NCT01440764|FG002|Participant Flow|Saline, Then F(40), Then IV.F|"On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
11074811|NCT01440764|FG003|Participant Flow|Saline, Then F(80), Then IV.F|"On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
11074812|NCT01440764|FG004|Participant Flow|F(80), Then Saline, Then Saline|"On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes."
11074813|NCT01440764|FG005|Participant Flow|Saline, Then F(80), Then Saline|"On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes."
11074814|NCT01440764|FG006|Participant Flow|Saline, Then Saline, Then F(80)|"On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes."
11074815|NCT01440764|OG000|Outcome|Aerosol Furosemide (40 mg)|"Participants who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject had used cannabis recently and their information was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
11074816|NCT01440764|OG001|Outcome|Aerosol Saline (4 ml)|"Participants who received Aerosol Saline (4ml) by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, only 11 participants received the intervention and completed the study day (one withdrew before starting this intervention).~Additionally, it was later discovered that 1 subject had used cannabis recently and their data was discarded.~Therefore, this analysis includes only the 10 subjects who met quality control."
11074817|NCT01440764|OG002|Outcome|IV Furosemide|"Participants who received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day and met quality control.~Of the 13 participants who consented to receive this intervention, only 12 participants received the intervention and completed the study day (one withdrew before starting this intervention).~Additionally, it was later discovered that 1 subject had used cannabis recently and their data was discarded. Also, 1 subject's data did not meet quality control and was excluded.~Therefore, this analysis includes only the 10 subjects who met quality control."
11074818|NCT01440764|OG003|Outcome|Aerosol Furosemide (80mg)|"Participants who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day and met quality control.~12 participants who consented to receive this intervention received the intervention and completed the study day. However, 1 subject's physiological data did not meet quality control and was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
11074819|NCT01440764|OG004|Outcome|Aerosol Saline (8 ml)|"Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days and met quality control.~12 participants who consented to receive this intervention received the intervention and completed the study day. However, 1 subject's physiological data did not meet quality control and was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
11074820|NCT01440764|OG001|Outcome|Aerosol Furosemide (80mg)|"Participants who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject's data did not pass a priori requirements for quality control and the subject's data was excluded. Therefore, this analysis includes only the 11 subjects who met quality control."
11074821|NCT01440764|OG000|Outcome|Aerosol Furosemide (40 mg)|"Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Saline (4ml) Arm and IV Furosemide Arm.~Furosemide"
11074822|NCT01440764|OG001|Outcome|Aerosol Furosemide (80mg)|"Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Saline (8ml) Arm.~Furosemide"
11074823|NCT01440764|OG002|Outcome|Aerosol Saline (4 ml)|"Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Furosemide (40mg) Arm and IV Furosemide Arm.~Saline"
10887649|NCT00501995|OG000|Outcome|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
11074824|NCT01440764|OG003|Outcome|Aerosol Saline (8 ml)|"Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.~To be compared to Aerosol Furosemide (80mg) Arm.~Saline"
11074825|NCT01440764|OG004|Outcome|IV Furosemide|"Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.~To be compared to Aerosol Furosemide (40mg) Arm and Aerosol Saline (4 ml) Arm.~Furosemide"
11074826|NCT01440764|EG000|Reported Event|Aerosol Furosemide (40 mg)|Any subject who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.
11074827|NCT01440764|EG001|Reported Event|Aerosol Furosemide (80mg)|Any subject who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.
11074828|NCT01440764|EG002|Reported Event|Aerosol Saline (4 ml)|Any subject who received Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.
11074829|NCT01440764|EG003|Reported Event|Aerosol Saline (8 ml)|Any subject who received Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.
11074830|NCT01440764|EG004|Reported Event|IV Furosemide|Any subject who received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.
11074831|NCT01440803|BG000|Baseline|Teriparatide (Forteo)|"Daily injection of Teriparatide for treatment of idiopathic osteoporosis~Teriparatide: Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months."
11074832|NCT01440803|BG001|Baseline|Placebo Saline Injection|"Daily injection of saline placebo for 6 months, followed by 24 months of teriparatide treatment for idiopathic osteoporosis.~Saline Placebo: Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months."
11074833|NCT01440803|BG002|Baseline|Total|Total of all reporting groups
11074834|NCT01440803|FG000|Participant Flow|Placebo Saline Injection|"First 6 months:~Placebo Saline Injection Group receiving daily injection of saline placebo~6-12 months: Placebo Saline Injection Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)~12-24 months: Forteo open label"
11074835|NCT01440803|FG001|Participant Flow|Teriparatide (Forteo)|"First 6 months:~Teriparatide (Forteo) Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)~6-12 months: Teriparatide (Forteo) Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)~12-24 months: Forteo open label"
11074836|NCT01440803|OG000|Outcome|Teriparatide (Forteo)|"Daily injection of Teriparatide for treatment of idiopathic osteoporosis~Teriparatide: Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months."
11074837|NCT01440803|OG001|Outcome|Placebo Saline Injection|"Daily injection of saline placebo for 6 months, followed by 24 months of teriparatide treatment for idiopathic osteoporosis.~Saline Placebo: Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months."
11074838|NCT01440803|EG000|Reported Event|Teriparatide (Forteo) (24 Months)|Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.
11074839|NCT01440803|EG001|Reported Event|Placebo Saline Injection (6 Months)|Daily injection of saline placebo for 6 months.
11074840|NCT01440803|EG002|Reported Event|Placebo Saline Injection (6-24 Months)|Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 18 months following placebo.
11074841|NCT01440816|BG000|Baseline|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
11074842|NCT01440816|BG001|Baseline|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
11074843|NCT01440816|BG002|Baseline|Total|Total of all reporting groups
11074844|NCT01440816|FG000|Participant Flow|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
11074845|NCT01440816|FG001|Participant Flow|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
11173586|NCT02016560|FG002|Participant Flow|Exploratory MCI Subjects|Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE Score ≥24
11074846|NCT01440816|OG000|Outcome|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
11074847|NCT01440816|OG000|Outcome|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
11074848|NCT01440816|OG001|Outcome|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
11074849|NCT01440816|OG000|Outcome|All Patients: Tavo-EP|All patients from Cohort A and Cohort B.
11074850|NCT01440816|EG000|Reported Event|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
11074851|NCT01440816|EG001|Reported Event|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
11074852|NCT01440881|BG000|Baseline|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
11074853|NCT01440881|BG001|Baseline|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
11074854|NCT01440881|BG002|Baseline|Total|Total of all reporting groups
11074855|NCT01440881|FG000|Participant Flow|Nesiritide|"infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
11074856|NCT01440881|FG001|Participant Flow|Placebo|"infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
11074857|NCT01440881|OG000|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
11074858|NCT01440881|OG001|Outcome|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
11074859|NCT01440881|OG001|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
11074860|NCT01440881|EG000|Reported Event|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
11074861|NCT01440881|EG001|Reported Event|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
11074862|NCT01440920|BG000|Baseline|Cohort 1|subcutaneously administered once a week, 4 times at the dose of 0.3 mg
11074863|NCT01440920|BG001|Baseline|Cohort 2|subcutaneously administered once a week, 4 times at the dose of 1 mg
11074864|NCT01440920|BG002|Baseline|Cohort 3|subcutaneously administered once a week, 4 times at the dose of 3 mg
11074865|NCT01440920|BG003|Baseline|Total|Total of all reporting groups
11074866|NCT01440920|FG000|Participant Flow|Cohort 1|subcutaneously administered once a week, 4 times at the dose of 0.3 mg
11074867|NCT01440920|FG001|Participant Flow|Cohort 2|subcutaneously administered once a week, 4 times at the dose of 1 mg
11074868|NCT01440920|FG002|Participant Flow|Cohort 3|subcutaneously administered once a week, 4 times at the dose of 3 mg
11074869|NCT01440920|OG000|Outcome|Cohort 1|subcutaneously administered once a week, 4 times at the dose of 0.3 mg
11074870|NCT01440920|OG001|Outcome|Cohort 2|subcutaneously administered once a week, 4 times at the dose of 1 mg
11074871|NCT01440920|OG002|Outcome|Cohort 3|subcutaneously administered once a week, 4 times at the dose of 3 mg
11074872|NCT01440920|EG000|Reported Event|Cohort 1|subcutaneously administered once a week, 4 times at the dose of 0.3 mg
11074873|NCT01440920|EG001|Reported Event|Cohort 2|subcutaneously administered once a week, 4 times at the dose of 1 mg
11074874|NCT01440920|EG002|Reported Event|Cohort 3|subcutaneously administered once a week, 4 times at the dose of 3 mg
11074875|NCT01440946|BG000|Baseline|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
11074876|NCT01440946|BG001|Baseline|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
11074877|NCT01440946|BG002|Baseline|Total|Total of all reporting groups
11074878|NCT01440946|FG000|Participant Flow|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single intravenous (IV) injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last pharmacokinetic (PK) sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
11074879|NCT01440946|FG001|Participant Flow|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
11074880|NCT01440946|OG000|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
11074881|NCT01440946|OG001|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
11074882|NCT01440946|OG002|Outcome|Total|All Participants
11173587|NCT02016560|FG003|Participant Flow|Exploratory AD Subjects|Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE Score >10
11074883|NCT01440946|EG000|Reported Event|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
11074884|NCT01440946|EG001|Reported Event|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
11074885|NCT01440959|BG000|Baseline|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
11074886|NCT01440959|FG000|Participant Flow|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
11074887|NCT01440959|OG000|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
11074888|NCT01440959|EG000|Reported Event|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
11074889|NCT01440972|BG000|Baseline|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
11074890|NCT01440972|BG001|Baseline|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
11074891|NCT01440972|BG002|Baseline|Total|Total of all reporting groups
11074892|NCT01440972|FG000|Participant Flow|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
11074893|NCT01440972|FG001|Participant Flow|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
11074894|NCT01440972|OG000|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
11074895|NCT01440972|OG001|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
11074896|NCT01440972|EG000|Reported Event|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
11074897|NCT01440972|EG001|Reported Event|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
11074898|NCT01441037|BG000|Baseline|Danazol|Oral administration of Danazol (800 mg daily divided into two doses per day) to be given for 2 years
11074899|NCT01441037|FG000|Participant Flow|Danazol|Oral administration of Danazol (800 mg daily divided into two doses per day) to be given for 2 years
11074900|NCT01441037|OG000|Outcome|Danazol|Oral administration of Danazol (800 mg daily divided into two doses per day) to be given for 2 years
11074901|NCT01441037|EG000|Reported Event|Danazol|Oral administration of Danazol (800 mg daily divided into two doses per day) to be given for 2 years
11074902|NCT01441063|BG000|Baseline|Tocilizumab|"Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.~Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)~Tocilizumab: Tocilizumab 8mg/kg every 2 weeks~Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle."
11074903|NCT01441063|FG000|Participant Flow|Tocilizumab|"Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.~Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)~Tocilizumab: Tocilizumab 8mg/kg every 2 weeks~Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.~KSHV-MCD = Kaposi sarcoma herpes virus-associated multicentric Castleman Disease"
11074904|NCT01441063|OG000|Outcome|Tocilizumab Monotherapy|"All participants (e.g. 8/8) who received Tocilizumab.~Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC)."
11074905|NCT01441063|OG001|Outcome|Tocilizumab Combination Therapy|3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
11074906|NCT01441063|OG000|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.~Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)~Tocilizumab: Tocilizumab 8mg/kg every 2 weeks~Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle."
11074907|NCT01441063|EG000|Reported Event|Tocilizumab Monotherapy|"All participants (e.g. 8/8) who received Tocilizumab.~Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC)."
11074908|NCT01441063|EG001|Reported Event|Tocilizumab Combination Therapy|3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
11074909|NCT01441076|BG000|Baseline|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
11074910|NCT01441076|FG000|Participant Flow|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
11074911|NCT01441076|OG000|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
11074912|NCT01441076|EG000|Reported Event|Anakinra|Treatment with Anakinra 100mg subcutaneous daily
11074913|NCT01441102|BG000|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
11074914|NCT01441102|FG000|Participant Flow|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
11074915|NCT01441102|OG000|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
11074916|NCT01441102|EG000|Reported Event|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
11074917|NCT01441180|BG000|Baseline|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
11074918|NCT01441180|BG001|Baseline|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
11074919|NCT01441180|BG002|Baseline|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
11074920|NCT01441180|BG003|Baseline|Total|Total of all reporting groups
11074921|NCT01441180|FG000|Participant Flow|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
11074922|NCT01441180|FG001|Participant Flow|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
11074923|NCT01441180|FG002|Participant Flow|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
11074924|NCT01441180|OG000|Outcome|Phase 1|
11074925|NCT01441180|OG001|Outcome|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
11074926|NCT01441180|OG002|Outcome|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
11074927|NCT01441180|OG000|Outcome|Phase 1|"Participants (N =10) will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.~GS7977~RBV"
11074928|NCT01441180|OG001|Outcome|Phase 2 Arm A|"(N =25) 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)~GS7977~RBV"
11074929|NCT01441180|OG002|Outcome|Phase 2 Arm B|"(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).~GS7977~RBV"
11074930|NCT01441180|EG000|Reported Event|Phase 1 (Sofosbuvir + Weight Based RBV)|(N =10): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
11074931|NCT01441180|EG001|Reported Event|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
11074932|NCT01441180|EG002|Reported Event|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
11074933|NCT01441245|BG000|Baseline|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
11074934|NCT01441245|BG001|Baseline|iIV Group|The group that received the intermittent infusion of furosemide (iIV), consisted of 27 patients.
11074935|NCT01441245|BG002|Baseline|Total|Total of all reporting groups
11074936|NCT01441245|FG000|Participant Flow|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
11074937|NCT01441245|FG001|Participant Flow|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
11074938|NCT01441245|OG000|Outcome|Urine Output in cIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
11074939|NCT01441245|OG001|Outcome|Urine Output in iIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
11074940|NCT01441245|OG000|Outcome|Lenght of Hospitalization in cIV|Prevalence of hospital stay > 10 days in continuous intravenous furosemide infusion.
11074941|NCT01441245|OG001|Outcome|Lenght of Hospitalization in iIV|Prevalence of hospital stay > 10 days in intermittent intravenous furosemide infusion.
11074942|NCT01441245|OG000|Outcome|Creatinine at Discharge in cIV|Mean creatinine at discharge in continuous intravenous fursoemide infusion.
11173588|NCT02016560|FG004|Participant Flow|Confirmatory Subjects MCI|Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
11074943|NCT01441245|OG001|Outcome|Creatinine at Discharge in iIV|Mean creatinine at discharge in intermittent intravenous fursoemide infusion.
11074944|NCT01441245|OG000|Outcome|Changes in Creatinine in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
11074945|NCT01441245|OG001|Outcome|Changes in Creatinine in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
11074946|NCT01441245|OG000|Outcome|BNP Levels at Discharge in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
11074947|NCT01441245|OG001|Outcome|BNP Levels at Discharge in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
11074948|NCT01441245|OG000|Outcome|BNP Change in cIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
11074949|NCT01441245|OG001|Outcome|BNP Change in iIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
11074950|NCT01441245|OG000|Outcome|GFR Change in cIV|Mean GFR change in continuous intravenous fursoemide infusion.
11074951|NCT01441245|OG001|Outcome|GFR Change in iIV|Mean GFR change in intermittent intravenous fursoemide infusion.
11074952|NCT01441245|OG000|Outcome|GFR at Discharge in cIV|Mean GFR at discharge in continuous intravenous fursoemide infusion.
11074953|NCT01441245|OG001|Outcome|GFR at Discharge in iIV|Mean GFR at discharge in intermittent intravenous fursoemide infusion.
11074954|NCT01441245|OG000|Outcome|Dopamine Infusion in cIV|Prevalence of dopamine infusion in continuous intravenous furosemide infusion.
11074955|NCT01441245|OG001|Outcome|Dopamine Infusion in iIV|Prevalence of dopamine infusion in intermittent intravenous furosemide infusion.
11074956|NCT01441245|EG000|Reported Event|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
11074957|NCT01441245|EG001|Reported Event|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
11074958|NCT01441401|BG000|Baseline|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
11074959|NCT01441401|FG000|Participant Flow|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
11074960|NCT01441401|OG000|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
11074961|NCT01441401|OG000|Outcome|Mild|Participants with mild epileptic seizure at baseline
11074962|NCT01441401|OG001|Outcome|Moderate|Participants with moderate epileptic seizure at baseline
11074963|NCT01441401|OG002|Outcome|Severe|Participants with severe epileptic seizure at baseline
11074964|NCT01441401|OG003|Outcome|Unknown|Participants with unknown severity of baseline epileptic seizure
11074965|NCT01441401|OG000|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure 8 or less
11074966|NCT01441401|OG001|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8
11074967|NCT01441401|OG002|Outcome|Unknown|Participants with unknown frequency of baseline epileptic seizure
11074968|NCT01441401|OG000|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
11074969|NCT01441401|OG001|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
11074970|NCT01441401|OG002|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
11074971|NCT01441401|OG003|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
11074972|NCT01441401|OG004|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
11074973|NCT01441401|OG000|Outcome|Non-Long Term|Participants who received gabapentin for less than 1 year
11074974|NCT01441401|OG001|Outcome|Long Term|Participants who received gabapentin for 1 year or more
11173589|NCT02016560|FG005|Participant Flow|Confirmatory Subjects AD|Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
11173590|NCT02016560|OG000|Outcome|Predicted to Progress|Subjects with an Advanced AD Scan Pattern (τAD++). In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the PLT, parietal, or occipital region(s).
11074975|NCT01441401|EG000|Reported Event|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
11074976|NCT01441414|BG000|Baseline|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
11074977|NCT01441414|FG000|Participant Flow|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
11074978|NCT01441414|OG000|Outcome|All-causality CTCAE Grade 3|Incidence and severity of all-causality CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
11074979|NCT01441414|OG001|Outcome|All-causality CTCAE Grade 4|Incidence and severity of all-causality CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
11074980|NCT01441414|OG002|Outcome|All-causality CTCAE Grade 5|Incidence and severity of all-causality CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
11074981|NCT01441414|OG003|Outcome|Treatment-related CTCAE Grade 3|Incidence and severity of treatment-related CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
11074982|NCT01441414|OG004|Outcome|Treatment-related CTCAE Grade 4|Incidence and severity of treatment-related CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
11074983|NCT01441414|OG005|Outcome|Treatment-related CTCAE Grade 5|Incidence and severity of treatment-related CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
11074984|NCT01441414|OG006|Outcome|All-causality Overall|Incidence and severity of all-causality CTCAE Grades 3, 4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
11074985|NCT01441414|OG007|Outcome|Treatment-related Overall|Incidence and severity of treatment-related CTCAE Grades 3,4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
11074986|NCT01441414|OG000|Outcome|All-causality CTCAE Grade 2|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 2 TEAEs are presented
11227378|NCT02382913|BG007|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11074987|NCT01441414|OG001|Outcome|All-causality CTCAE Grade 3|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 3 TEAEs are presented
11074988|NCT01441414|OG002|Outcome|All-causality CTCAE Grade 4|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 4 TEAEs are presented
11074989|NCT01441414|OG003|Outcome|All-causality CTCAE Grade 5|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 5 TEAEs are presented
11074990|NCT01441414|OG000|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
11074991|NCT01441414|EG000|Reported Event|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
11074992|NCT01441440|BG000|Baseline|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
11074993|NCT01441440|BG001|Baseline|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
11074994|NCT01441440|BG002|Baseline|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
11074995|NCT01441440|BG003|Baseline|Total|Total of all reporting groups
11074996|NCT01441440|FG000|Participant Flow|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
11074997|NCT01441440|FG001|Participant Flow|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
11074998|NCT01441440|FG002|Participant Flow|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
11074999|NCT01441440|OG000|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
11075000|NCT01441440|OG001|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
11075001|NCT01441440|OG002|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
11075002|NCT01441440|EG000|Reported Event|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
11075003|NCT01441440|EG001|Reported Event|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
11075004|NCT01441440|EG002|Reported Event|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
11075005|NCT01441466|BG000|Baseline|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
11075006|NCT01441466|BG001|Baseline|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
11075007|NCT01441466|BG002|Baseline|Total|Total of all reporting groups
11075008|NCT01441466|FG000|Participant Flow|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
11075009|NCT01441466|FG001|Participant Flow|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
11075010|NCT01441466|OG000|Outcome|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
11075011|NCT01441466|OG001|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
11075012|NCT01441466|OG000|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
11075013|NCT01441466|EG000|Reported Event|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
11075014|NCT01441466|EG001|Reported Event|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
11075015|NCT01441492|BG000|Baseline|No Drains|"Patients did not receive intraperitoneal drainage following pancreas resection.~No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group."
11075016|NCT01441492|BG001|Baseline|Drains|"Patients did receive drain(s), the standard of care treatment, following pancreas resection.~Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care)."
11075017|NCT01441492|BG002|Baseline|Total|Total of all reporting groups
11075018|NCT01441492|FG000|Participant Flow|No Drains|"Patients did not receive intraperitoneal drainage following pancreas resection.~No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group."
11075019|NCT01441492|FG001|Participant Flow|Drains|"Patients did receive drain(s), the standard of care treatment, following pancreas resection.~Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care)."
11075020|NCT01441492|OG000|Outcome|No Drains|"Patients did not receive intraperitoneal drainage following pancreas resection.~No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group."
11075021|NCT01441492|OG001|Outcome|Drains|"Patients did receive drain(s), the standard of care treatment, following pancreas resection.~Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care)."
11075022|NCT01441492|OG000|Outcome|No Drains|"Patients who will not receive intraperitoneal drainage following pancreas resection.~No Drains: A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group."
11075023|NCT01441492|OG001|Outcome|Drains|"Patients who will receive drains, the standard of care treatment, following pancreas resection.~Drains: A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care)."
11075024|NCT01441492|EG000|Reported Event|No Drains|"Patients did not receive intraperitoneal drainage following pancreas resection.~No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group."
11075025|NCT01441492|EG001|Reported Event|Drains|"Patients did receive drain(s), the standard of care treatment, following pancreas resection.~Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care)."
11075026|NCT01441570|BG000|Baseline|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
11075027|NCT01441570|BG001|Baseline|Metoprolol Succinate|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
11075028|NCT01441570|BG002|Baseline|Total|Total of all reporting groups
11075029|NCT01441570|FG000|Participant Flow|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
11075030|NCT01441570|FG001|Participant Flow|Metoprolol Succinate|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
11075031|NCT01441570|OG000|Outcome|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
11075032|NCT01441570|OG001|Outcome|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
11075033|NCT01441570|EG000|Reported Event|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
11075034|NCT01441570|EG001|Reported Event|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
11075035|NCT01441596|BG000|Baseline|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
11075036|NCT01441596|BG001|Baseline|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
11075037|NCT01441596|BG002|Baseline|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
11075038|NCT01441596|BG003|Baseline|Total|Total of all reporting groups
11075039|NCT01441596|FG000|Participant Flow|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
11075040|NCT01441596|FG001|Participant Flow|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
11075041|NCT01441596|FG002|Participant Flow|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
11075042|NCT01441596|OG000|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
11075043|NCT01441596|OG001|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
11075044|NCT01441596|OG002|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
11075045|NCT01441596|EG000|Reported Event|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
11075046|NCT01441596|EG001|Reported Event|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
11075047|NCT01441596|EG002|Reported Event|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
11075048|NCT01441635|BG000|Baseline|Cohort 4 Elagolix 400 mg QD|Participants received elagolix 400 mg once a day (QD) for 3 months.
11075049|NCT01441635|BG001|Baseline|Cohort 4 Elagolix 100 mg BID|Participants received elagolix 100 mg twice a day (BID) for 3 months.
11075050|NCT01441635|BG002|Baseline|Cohort 4 Placebo|Participants received placebo to elagolix BID for 3 months.
11075051|NCT01441635|BG003|Baseline|Cohort 1 Elagolix 200 mg BID|Participants received elagolix 200 mg twice a day for 3 months.
11075052|NCT01441635|BG004|Baseline|Cohort 1 Placebo|Participants received placebo to elagolix twice a day for 3 months.
11075053|NCT01441635|BG005|Baseline|Cohort 3 Elagolix 200 mg BID + LD E2/NETA|Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
11075054|NCT01441635|BG006|Baseline|Cohort 5 Elagolix 600 mg QD|Participants received elagolix 600 mg once a day for 3 months.
11075055|NCT01441635|BG007|Baseline|Cohort 2 Elagolix 300 mg BID|Participants received elagolix 300 mg twice a day for 3 months.
11075056|NCT01441635|BG008|Baseline|Cohort 2 Placebo|Participants received placebo to elagolix BID for 3 months.
11075057|NCT01441635|BG009|Baseline|Cohort 6 Elagolix 300 mg BID + CEP|Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
11075058|NCT01441635|BG010|Baseline|Total|Total of all reporting groups
11075059|NCT01441635|FG000|Participant Flow|Cohort 4 Elagolix 400 mg QD|Participants received elagolix 400 mg once a day (QD) for 3 months.
11075060|NCT01441635|FG001|Participant Flow|Cohort 4 Elagolix 100 mg BID|Participants received elagolix 100 mg twice a day (BID) for 3 months.
11075061|NCT01441635|FG002|Participant Flow|Cohort 4 Placebo|Participants received placebo to elagolix BID for 3 months.
11075062|NCT01441635|FG003|Participant Flow|Cohort 1 Elagolix 200 mg BID|Participants received elagolix 200 mg twice a day for 3 months.
11075063|NCT01441635|FG004|Participant Flow|Cohort 1 Placebo|Participants received placebo to elagolix twice a day for 3 months.
11075064|NCT01441635|FG005|Participant Flow|Cohort 3 Elagolix 200 mg BID + LD E2/NETA|Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
11075065|NCT01441635|FG006|Participant Flow|Cohort 5 Elagolix 600 mg QD|Participants received elagolix 600 mg once a day for 3 months.
11075066|NCT01441635|FG007|Participant Flow|Cohort 2 Elagolix 300 mg BID|Participants received elagolix 300 mg twice a day for 3 months.
11075067|NCT01441635|FG008|Participant Flow|Cohort 2 Placebo|Participants received placebo to elagolix BID for 3 months.
11075068|NCT01441635|FG009|Participant Flow|Cohort 6 Elagolix 300 mg BID + CEP|Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
11075069|NCT01441635|OG000|Outcome|Cohort 4 Elagolix 400 mg QD|Participants received elagolix 400 mg once a day (QD) for 3 months.
11075070|NCT01441635|OG001|Outcome|Cohort 4 Elagolix 100 mg BID|Participants received elagolix 100 mg twice a day (BID) for 3 months.
11075071|NCT01441635|OG002|Outcome|Cohort 4 Placebo|Participants received placebo to elagolix BID for 3 months.
11075072|NCT01441635|OG003|Outcome|Cohort 1 Elagolix 200 mg BID|Participants received elagolix 200 mg twice a day for 3 months.
11075073|NCT01441635|OG004|Outcome|Cohort 1 Placebo|Participants received placebo to elagolix twice a day for 3 months.
11075074|NCT01441635|OG005|Outcome|Cohort 3 Elagolix 200 mg BID + LD E2/NETA|Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
11075075|NCT01441635|OG006|Outcome|Cohort 5 Elagolix 600 mg QD|Participants received elagolix 600 mg once a day for 3 months.
11075076|NCT01441635|OG007|Outcome|Cohort 2 Elagolix 300 mg BID|Participants received elagolix 300 mg twice a day for 3 months.
11075077|NCT01441635|OG008|Outcome|Cohort 2 Placebo|Participants received placebo to elagolix BID for 3 months.
11075078|NCT01441635|OG009|Outcome|Cohort 6 Elagolix 300 mg BID + CEP|Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
11075079|NCT01441635|EG000|Reported Event|Cohort 1 Placebo|Participants received placebo to elagolix twice a day for 3 months.
11075080|NCT01441635|EG001|Reported Event|Cohort 1 Elagolix 200 mg BID|Participants received elagolix 200 mg twice a day for 3 months.
11075081|NCT01441635|EG002|Reported Event|Cohort 2 Placebo|Participants received placebo to elagolix BID for 3 months.
11075082|NCT01441635|EG003|Reported Event|Cohort 2 Elagolix 300 mg BID|Participants received elagolix 300 mg twice a day for 3 months
11075083|NCT01441635|EG004|Reported Event|Cohort 3 Elagolix 200 mg BID + LD E2/NETA|Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
11075084|NCT01441635|EG005|Reported Event|Cohort 4 Placebo|Participants received placebo to elagolix BID for 3 months.
11075085|NCT01441635|EG006|Reported Event|Cohort 4 Elagolix 100 mg BID|Participants received elagolix 100 mg twice a day (BID) for 3 months.
11075086|NCT01441635|EG007|Reported Event|Cohort 4 Golix 400 mg QD|Participants received elagolix 400 mg once a day (QD) for 3 months.
11075087|NCT01441635|EG008|Reported Event|Cohort 5 Elagolix 600 mg QD|Participants received elagolix 600 mg once a day for 3 months.
11075088|NCT01441635|EG009|Reported Event|Cohort 6 Elagolix 300 mg BID + CEP|Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
11075089|NCT01441765|BG000|Baseline|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
11075090|NCT01441765|BG001|Baseline|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
11075091|NCT01441765|BG002|Baseline|Total|Total of all reporting groups
11075092|NCT01441765|FG000|Participant Flow|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
11075093|NCT01441765|FG001|Participant Flow|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
11075094|NCT01441765|OG000|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
11075095|NCT01441765|OG001|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
11075096|NCT01441765|EG000|Reported Event|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
11075097|NCT01441765|EG001|Reported Event|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
11075098|NCT01441843|BG000|Baseline|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
11075099|NCT01441843|BG001|Baseline|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
11075100|NCT01441843|BG002|Baseline|Total|Total of all reporting groups
11075101|NCT01441843|FG000|Participant Flow|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
11075102|NCT01441843|FG001|Participant Flow|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
11075103|NCT01441843|OG000|Outcome|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
11075104|NCT01441843|OG001|Outcome|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
11075105|NCT01441843|EG000|Reported Event|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
11075106|NCT01441843|EG001|Reported Event|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
11075107|NCT01441882|BG000|Baseline|Treatment (Dasatinib)|"Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11075108|NCT01441882|FG000|Participant Flow|Treatment (Dasatinib)|"Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11075109|NCT01441882|OG000|Outcome|Treatment (Dasatinib)|"Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11075110|NCT01441882|EG000|Reported Event|Treatment (Dasatinib)|"Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11075111|NCT01441960|BG000|Baseline|Succinylcholine and Rocuronium|All study participants
11075112|NCT01441960|FG000|Participant Flow|Succinylcholine First, Then Rocuronium|"After induction of anesthesia Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.~By identifying the optimal (minimal effective) dose of succinylcholine, Rocuronium bromide (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg."
11075113|NCT01441960|FG001|Participant Flow|Rocuronium First , Then Succinylcholine|"After induction of anesthesia Rocuronium (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the rocuronium-induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.~By identifying the optimal (minimal effective) dose of rocuronium, in the subsequent treatment of the subject, Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline."
11075114|NCT01441960|OG000|Outcome|NMBA: Sux|"Cross-over randomized controlled, assessor blinded clinical trial.~Succinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'."
11075115|NCT01441960|OG001|Outcome|NMBA- Rocuronium|Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
11075116|NCT01441960|OG000|Outcome|Succinylchline|Time to recovery after single bolus administered at the beginning of ECT therapy
11075117|NCT01441960|OG001|Outcome|Rocuronium|Time to recovery after single bolus administered at the beginning of ECT therapy
11075118|NCT01441960|OG000|Outcome|Succinylcholine|Duration of induced seizure after standard ECT
11075119|NCT01441960|OG001|Outcome|Rocuronium|Duration of induced seizure
11075120|NCT01441960|EG000|Reported Event|NMBA: Succinylcholine|No adverse events occurred during the study
11075121|NCT01441960|EG001|Reported Event|NMBA: Rocuronium|No adverse events occurred during the study
11075122|NCT01441973|BG000|Baseline|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
11075123|NCT01441973|BG001|Baseline|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
11075124|NCT01441973|BG002|Baseline|Total|Total of all reporting groups
11075125|NCT01441973|FG000|Participant Flow|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
11075126|NCT01441973|FG001|Participant Flow|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
11075127|NCT01441973|OG000|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
11075128|NCT01441973|OG001|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
11075129|NCT01441973|OG002|Outcome|Elotuzumab, All Dosages|All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
11075130|NCT01441973|EG000|Reported Event|Elotuzumab(E) : 10 mg/kg/Dose|
11075131|NCT01441973|EG001|Reported Event|Elotuzumab(E) : 20 mg/kg/Dose|
11075132|NCT01442038|BG000|Baseline|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
11075133|NCT01442038|BG001|Baseline|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
11075134|NCT01442038|BG002|Baseline|Total|Total of all reporting groups
11075135|NCT01442038|FG000|Participant Flow|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
11075136|NCT01442038|FG001|Participant Flow|Placebo|Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
11075137|NCT01442038|OG000|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
11075138|NCT01442038|OG001|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
11075139|NCT01442038|EG000|Reported Event|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
11075140|NCT01442038|EG001|Reported Event|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
11075141|NCT01442064|BG000|Baseline|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
11075142|NCT01442064|BG001|Baseline|Ranibizumab (0.3 mg BRAVO)|In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
11227379|NCT02382913|BG008|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11075143|NCT01442064|BG002|Baseline|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
11075144|NCT01442064|BG003|Baseline|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
11075145|NCT01442064|BG004|Baseline|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
11075146|NCT01442064|BG005|Baseline|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
11349091|NCT04123665|BG001|Baseline|Control Sodium Monofluorophosphate Dentifrice|In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million [ppm] fluoride as sodium monofluorophosphate [SMFP] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
11075147|NCT01442064|BG006|Baseline|Total|Total of all reporting groups
11075148|NCT01442064|FG000|Participant Flow|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
11075149|NCT01442064|FG001|Participant Flow|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
11349092|NCT04123665|BG002|Baseline|Total|Total of all reporting groups
11075150|NCT01442064|FG002|Participant Flow|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
11075151|NCT01442064|FG003|Participant Flow|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
11075152|NCT01442064|FG004|Participant Flow|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
11075153|NCT01442064|FG005|Participant Flow|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
11075154|NCT01442064|OG000|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
11075155|NCT01442064|OG001|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
11075156|NCT01442064|OG002|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
11075157|NCT01442064|OG003|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
11075158|NCT01442064|OG004|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
11075159|NCT01442064|OG005|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
11075160|NCT01442064|OG000|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
11075161|NCT01442064|OG001|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
11075162|NCT01442064|OG002|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
11075163|NCT01442064|OG003|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year)for 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
11075164|NCT01442064|OG004|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
11075165|NCT01442064|OG005|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
11075166|NCT01442064|EG000|Reported Event|Ranibizumab (Sham)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE and received Ranibizumab during the 6 month observation period of the initial study or this extension study.
11227380|NCT02382913|BG009|Baseline|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11075167|NCT01442064|EG001|Reported Event|Ranibizumab (0.3 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
11075168|NCT01442064|EG002|Reported Event|Ranibizumab (0.5 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
11075169|NCT01442103|BG000|Baseline|Silver Gel, Chronic Wounds|Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds.
11075170|NCT01442103|FG000|Participant Flow|Silver Gel, Chronic Wounds|The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
11075171|NCT01442103|OG000|Outcome|Device Common Dressing|Normlgel® Ag is an opaque, amorphous hyrdrogel containing a high (>80%) water content and water soluble polymer chains.
11075172|NCT01442103|EG000|Reported Event|Device Common Dressing|Normal Ag is an opaque, amorphous hydrogel containing a high watersoluble polymer chains and an antimicrobial silver compund
11075173|NCT01442129|BG000|Baseline|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
11075174|NCT01442129|BG001|Baseline|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
11075175|NCT01442129|BG002|Baseline|Total|Total of all reporting groups
11075176|NCT01442129|FG000|Participant Flow|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
11075177|NCT01442129|FG001|Participant Flow|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
11075178|NCT01442129|OG000|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
11075179|NCT01442129|OG001|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
11075180|NCT01442129|EG000|Reported Event|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
11075181|NCT01442129|EG001|Reported Event|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
11075182|NCT01442155|BG000|Baseline|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
11075183|NCT01442155|FG000|Participant Flow|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
11075184|NCT01442155|OG000|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
11075185|NCT01442155|EG000|Reported Event|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
11075186|NCT01442181|BG000|Baseline|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
11075187|NCT01442181|BG001|Baseline|Medical Therapy|Patients are treated with rhythm and rate control medications.
11075188|NCT01442181|BG002|Baseline|Total|Total of all reporting groups
11075189|NCT01442181|FG000|Participant Flow|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
11075190|NCT01442181|FG001|Participant Flow|Medical Therapy|Patients are treated with rhythm and rate control medications.
11075191|NCT01442181|OG000|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
11075192|NCT01442181|OG001|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
11075193|NCT01442181|OG001|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
11075194|NCT01442181|EG000|Reported Event|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
11075195|NCT01442181|EG001|Reported Event|Medical Therapy|Patients are treated with rhythm and rate control medications.
11227381|NCT02382913|BG010|Baseline|Total|Total of all reporting groups
11075196|NCT01442376|BG000|Baseline|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
11075197|NCT01442376|BG001|Baseline|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
11075198|NCT01442376|BG002|Baseline|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
11075199|NCT01442376|BG003|Baseline|Total|Total of all reporting groups
11075200|NCT01442376|FG000|Participant Flow|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
11075201|NCT01442376|FG001|Participant Flow|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
11075202|NCT01442376|FG002|Participant Flow|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
11075203|NCT01442376|OG000|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
11075204|NCT01442376|OG001|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
11075205|NCT01442376|OG002|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
11075206|NCT01442376|EG000|Reported Event|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
11075207|NCT01442376|EG001|Reported Event|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
11075208|NCT01442376|EG002|Reported Event|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
11075209|NCT01442493|BG000|Baseline|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
11075210|NCT01442493|BG001|Baseline|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
11075211|NCT01442493|BG002|Baseline|Total|Total of all reporting groups
11075212|NCT01442493|FG000|Participant Flow|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
11075213|NCT01442493|FG001|Participant Flow|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
11075214|NCT01442493|OG000|Outcome|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
11075215|NCT01442493|OG001|Outcome|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
11075216|NCT01442493|EG000|Reported Event|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
11075217|NCT01442493|EG001|Reported Event|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
11075218|NCT01442675|BG000|Baseline|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
11075219|NCT01442675|FG000|Participant Flow|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study.
11075220|NCT01442675|OG000|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
11075221|NCT01442675|OG000|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
11075222|NCT01442675|EG000|Reported Event|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age >= 11 years received a single dose of Menactra vaccine
11075223|NCT01442688|BG000|Baseline|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
11075224|NCT01442688|BG001|Baseline|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
11075225|NCT01442688|BG002|Baseline|Total|Total of all reporting groups
11075226|NCT01442688|FG000|Participant Flow|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
11075227|NCT01442688|FG001|Participant Flow|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
11075228|NCT01442688|OG000|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
11075229|NCT01442688|OG001|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
11075230|NCT01442688|EG000|Reported Event|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
11075231|NCT01442688|EG001|Reported Event|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
11075232|NCT01442714|BG000|Baseline|Azacitidine Plus Lenalidomide|Azacitidine + Lenalidomide Combo
11075233|NCT01442714|FG000|Participant Flow|Azacitidine Plus Lenalidomide|"Patients will receive a single dose of azacitidine 75mg/m2 SC/IV on d 1 to 7, followed by lenalidomide 50mg PO daily on d 8 to 28 of a 42-day cycle.~Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death~Lenalidomide: Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory"
11075234|NCT01442714|OG000|Outcome|Azacitidine Plus Lenalidomide|Acute myeloid leukemia (AML) ORR was defined as the sum of Complete Response (CR) + CR with incomplete count recovery (CRi) + Partial Response (PR): (CR + CRi + PR)
11075235|NCT01442714|OG000|Outcome|Azacitidine Plus Lenalidomide|"Patients will receive a single dose of azacitidine 75mg/m2 SC/IV on d 1-7, followed by lenalidomide 50mg PO daily on d 8-28 of a 42-day cycle.~Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death. Lenalidomide: Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory."
11075236|NCT01442714|OG000|Outcome|Azacitidine Plus Lenalidomide|"Patients will receive a single dose of azacitidine 75mg/m2 SC/IV on d 1 to 7, followed by lenalidomide 50mg PO daily on d 8 to 28 of a 42-day cycle.~Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death~Lenalidomide: Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory"
11173591|NCT02016560|OG001|Outcome|Not Predicted to Progress|Subjects with a Moderate AD Scan Pattern (τAD+) or Not AD Scan Pattern (τAD-). Moderate scans were defined as in either hemisphere, increased neocortical activity limited to the posterolateral temporal (PLT) or occipital region(s). Not AD scans were defined as no increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
11173592|NCT02016560|OG000|Outcome|Exploratory AD Subjects|Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE >10
11075237|NCT01442714|EG000|Reported Event|Azacitidine Plus Lenalidomide|"Patients will receive a single dose of azacitidine 75mg/m2 SC/IV on d 1 to 7, followed by lenalidomide 50mg PO daily on d 8 to 28 of a 42-day cycle.~Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death~Lenalidomide: Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory."
11075238|NCT01442779|BG000|Baseline|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
11075239|NCT01442779|FG000|Participant Flow|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
11075240|NCT01442779|OG000|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
11075241|NCT01442779|EG000|Reported Event|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
11075242|NCT01442844|BG000|Baseline|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
11075243|NCT01442844|BG001|Baseline|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
11075244|NCT01442844|BG002|Baseline|Total|Total of all reporting groups
11075245|NCT01442844|FG000|Participant Flow|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
11075246|NCT01442844|FG001|Participant Flow|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
11075247|NCT01442844|OG000|Outcome|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
11075248|NCT01442844|OG001|Outcome|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
11075249|NCT01442844|EG000|Reported Event|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
11075250|NCT01442844|EG001|Reported Event|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
11075251|NCT01443026|BG000|Baseline|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
11075252|NCT01443026|BG001|Baseline|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
11075253|NCT01443026|BG002|Baseline|Total|Total of all reporting groups
11075254|NCT01443026|FG000|Participant Flow|Lycopene|"Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)~Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
11075255|NCT01443026|FG001|Participant Flow|Placebo|"Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)~Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
11075256|NCT01443026|OG000|Outcome|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
11075257|NCT01443026|OG001|Outcome|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
11075258|NCT01443026|EG000|Reported Event|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
11075259|NCT01443026|EG001|Reported Event|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
11075260|NCT01443078|BG000|Baseline|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
11075261|NCT01443078|FG000|Participant Flow|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
11075262|NCT01443078|OG000|Outcome|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
11075263|NCT01443078|EG000|Reported Event|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
11075264|NCT01443130|BG000|Baseline|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
11075265|NCT01443130|BG001|Baseline|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
11075266|NCT01443130|BG002|Baseline|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
11075267|NCT01443130|BG003|Baseline|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
11075268|NCT01443130|BG004|Baseline|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
11075269|NCT01443130|BG005|Baseline|Infant SP IPT|Infants born to maternal participants who received SP IPT.
11075270|NCT01443130|BG006|Baseline|Total|Total of all reporting groups
11075271|NCT01443130|FG000|Participant Flow|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
11075272|NCT01443130|FG001|Participant Flow|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
11075273|NCT01443130|FG002|Participant Flow|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
11075274|NCT01443130|FG003|Participant Flow|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
11075275|NCT01443130|FG004|Participant Flow|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
11075276|NCT01443130|FG005|Participant Flow|Infant SP IPT|Infants born to maternal participants who received SP IPT.
11075277|NCT01443130|OG000|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
11075278|NCT01443130|OG001|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
11075279|NCT01443130|OG002|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
11075280|NCT01443130|OG000|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
11075281|NCT01443130|OG001|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
11075282|NCT01443130|OG002|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
11075283|NCT01443130|EG000|Reported Event|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
11075284|NCT01443130|EG001|Reported Event|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
11075285|NCT01443130|EG002|Reported Event|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
11075286|NCT01443130|EG003|Reported Event|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
11075287|NCT01443130|EG004|Reported Event|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
11075288|NCT01443130|EG005|Reported Event|Infant SP IPT|Infants born to maternal participants who received SP IPT.
11075289|NCT01443364|BG000|Baseline|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
11075290|NCT01443364|FG000|Participant Flow|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
11075291|NCT01443364|OG000|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
11075292|NCT01443364|EG000|Reported Event|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
11075293|NCT01443403|BG000|Baseline|Placebo|Participants received placebo orally once daily for 28 days.
11075294|NCT01443403|BG001|Baseline|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
11075295|NCT01443403|BG002|Baseline|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
11075296|NCT01443403|BG003|Baseline|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
11075297|NCT01443403|BG004|Baseline|Total|Total of all reporting groups
11075298|NCT01443403|FG000|Participant Flow|Placebo|Participants received placebo orally once daily for 28 days.
11075299|NCT01443403|FG001|Participant Flow|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
11075300|NCT01443403|FG002|Participant Flow|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
11075301|NCT01443403|FG003|Participant Flow|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
11075302|NCT01443403|OG000|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
11075303|NCT01443403|OG001|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
11075304|NCT01443403|OG002|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
11075305|NCT01443403|OG003|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
11075306|NCT01443403|OG000|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
11075307|NCT01443403|OG001|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
11075308|NCT01443403|OG002|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
11075309|NCT01443403|EG000|Reported Event|Placebo|Participants received placebo orally once daily for 28 days.
11075310|NCT01443403|EG001|Reported Event|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
11075311|NCT01443403|EG002|Reported Event|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
11075312|NCT01443403|EG003|Reported Event|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
11075313|NCT01443442|BG000|Baseline|Bepreve|"1.5% bepotastine besilate, drops, twice per day, for two weeks~bepotastine besilate, 1.5%: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days"
11075314|NCT01443442|BG001|Baseline|Alrex|"treatment with 0.2 % loteprednol etabonate, drops, four times per day~Loteprednol etabonate: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days"
11075315|NCT01443442|BG002|Baseline|Total|Total of all reporting groups
11075316|NCT01443442|FG000|Participant Flow|Bepreve|"1.5% bepotastine besilate, drops, twice per day, for two weeks~bepotastine besilate, 1.5%: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days"
11075317|NCT01443442|FG001|Participant Flow|Alrex|"treatment with 0.2 % loteprednol etabonate, drops, four times per day~Loteprednol etabonate: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days"
11075318|NCT01443442|OG000|Outcome|Bepreve|"1.5% bepotastine besilate, drops, twice per day, for two weeks~bepotastine besilate, 1.5%: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days"
11075319|NCT01443442|OG001|Outcome|Alrex|"treatment with 0.2 % loteprednol etabonate, drops, four times per day~Loteprednol etabonate: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days"
11075320|NCT01443442|EG000|Reported Event|Bepreve|"1.5% bepotastine besilate, drops, twice per day, for two weeks~bepotastine besilate, 1.5%: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days"
11075321|NCT01443442|EG001|Reported Event|Alrex|"treatment with 0.2 % loteprednol etabonate, drops, four times per day~Loteprednol etabonate: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days"
11075322|NCT01443494|BG000|Baseline|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
11075323|NCT01443494|FG000|Participant Flow|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
11075324|NCT01443494|OG000|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
11075325|NCT01443494|EG000|Reported Event|Septic Shock Patients Despite EGDT|Patients requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
11075326|NCT01443546|BG000|Baseline|Human Chorionic Gonadotropin|"standard dose of hCG for ovulation trigger~HCG: hCG Trigger"
11075327|NCT01443546|BG001|Baseline|Lupron Trigger|"Leuprolide acetate 2 mg ovulation trigger~Lupron Trigger: leuprolide acetate 2 mg SQ"
11075328|NCT01443546|BG002|Baseline|Dual Trigger|"Lupron and hCG combined ovulation trigger~Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU)."
11075329|NCT01443546|BG003|Baseline|Total|Total of all reporting groups
11075330|NCT01443546|FG000|Participant Flow|Human Chorionic Gonadotropin|"standard dose of hCG for ovulation trigger~HCG: hCG Trigger"
11075331|NCT01443546|FG001|Participant Flow|Lupron Trigger|"Leuprolide acetate 2 mg ovulation trigger~Lupron Trigger: leuprolide acetate 2 mg SQ"
11075332|NCT01443546|FG002|Participant Flow|Dual Trigger|"Lupron and hCG combined ovulation trigger~Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU)."
11075333|NCT01443546|OG000|Outcome|hCG Trigger|"standard dose of hCG for ovulation trigger~HCG: hCG Trigger"
11075334|NCT01443546|OG001|Outcome|Dual Trigger|"Lupron and hCG combined ovulation trigger~Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU)."
11075335|NCT01443546|OG002|Outcome|Lupron Trigger|"Leuprolide acetate 2 mg ovulation trigger~Lupron Trigger: leuprolide acetate 2 mg SQ"
11075336|NCT01443546|OG001|Outcome|Lupron Trigger|"Leuprolide acetate 2 mg ovulation trigger~Lupron Trigger: leuprolide acetate 2 mg SQ"
11075337|NCT01443546|OG002|Outcome|Dual Trigger|"Lupron and hCG combined ovulation trigger~Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU)."
11075338|NCT01443546|EG000|Reported Event|hCG Trigger|"standard dose of hCG for ovulation trigger~HCG: hCG Trigger"
11075339|NCT01443546|EG001|Reported Event|Dual Trigger|"Lupron and hCG combined ovulation trigger~Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU)."
11075340|NCT01443546|EG002|Reported Event|Lupron Trigger|"Leuprolide acetate 2 mg ovulation trigger~Lupron Trigger: leuprolide acetate 2 mg SQ"
11075341|NCT01443845|BG000|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
11075342|NCT01443845|BG001|Baseline|Roflumilast|Roflumilast 500 µg, oral administration, once per day
11075343|NCT01443845|BG002|Baseline|Total|Total of all reporting groups
11075344|NCT01443845|FG000|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
11075345|NCT01443845|FG001|Participant Flow|Roflumilast|Roflumilast 500 µg, oral administration, once per day
11075346|NCT01443845|OG000|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
11075347|NCT01443845|OG001|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
11075348|NCT01443845|EG000|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
11075349|NCT01443845|EG001|Reported Event|Roflumilast|Roflumilast 500 µg, oral administration, once per day
11075350|NCT01443858|BG000|Baseline|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075351|NCT01443858|BG001|Baseline|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075352|NCT01443858|BG002|Baseline|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075353|NCT01443858|BG003|Baseline|Total|Total of all reporting groups
11075354|NCT01443858|FG000|Participant Flow|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075355|NCT01443858|FG001|Participant Flow|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075356|NCT01443858|FG002|Participant Flow|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075357|NCT01443858|OG000|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075358|NCT01443858|OG001|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11173593|NCT02016560|OG001|Outcome|Exploratory MCI Subjects|Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24
11173594|NCT02016560|OG002|Outcome|Exploratory Older Cognitively Healthy Subjects|Male or female subjects ≥50 years of age with MMSE ≥29
11075359|NCT01443858|OG002|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075360|NCT01443858|EG000|Reported Event|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075361|NCT01443858|EG001|Reported Event|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075362|NCT01443858|EG002|Reported Event|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
11075363|NCT01444027|BG000|Baseline|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
11075364|NCT01444027|BG001|Baseline|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
11075365|NCT01444027|BG002|Baseline|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
11075366|NCT01444027|BG003|Baseline|Total|Total of all reporting groups
11075367|NCT01444027|FG000|Participant Flow|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
11075368|NCT01444027|FG001|Participant Flow|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
11075369|NCT01444027|FG002|Participant Flow|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
11075370|NCT01444027|OG000|Outcome|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
11075371|NCT01444027|OG001|Outcome|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
11173595|NCT02016560|OG003|Outcome|Exploratory Young Cognitively Healthy Subjects|Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29
11173596|NCT02016560|OG000|Outcome|Exploratory AB+ (Amyloid Beta Positive)|Exploratory MCI or AD subjects with a positive florbetapir PET scan for amyloid
11075372|NCT01444027|OG002|Outcome|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
11075373|NCT01444027|EG000|Reported Event|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
11075374|NCT01444027|EG001|Reported Event|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
11075375|NCT01444027|EG002|Reported Event|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
11075376|NCT01444287|BG000|Baseline|All Subjects|Subjects who were enrolled and randomized to a trial arm.
11075377|NCT01444287|FG000|Participant Flow|All Study Participants|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. The four arms were Spectacles (no contact lenses), Narafilcon B, Polymacon A, and Lotrafilcon A, in random order during the sessions.
11075378|NCT01444287|OG000|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075379|NCT01444287|OG001|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075380|NCT01444287|OG002|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075381|NCT01444287|OG003|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075382|NCT01444287|OG000|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075383|NCT01444287|OG001|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075384|NCT01444287|OG002|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075385|NCT01444287|OG003|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075386|NCT01444287|EG000|Reported Event|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075387|NCT01444287|EG001|Reported Event|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075388|NCT01444287|EG002|Reported Event|Polymacon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075389|NCT01444287|EG003|Reported Event|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
11075390|NCT01444300|BG000|Baseline|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
11075391|NCT01444300|BG001|Baseline|Placebo|Placebo: placebo pill, twice daily (bid), for 12 weeks
11075392|NCT01444300|BG002|Baseline|Total|Total of all reporting groups
11075393|NCT01444300|FG000|Participant Flow|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
11075394|NCT01444300|FG001|Participant Flow|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
11075395|NCT01444300|OG000|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
11075396|NCT01444300|OG001|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
11075397|NCT01444300|OG001|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for for 12 weeks
11075398|NCT01444300|EG000|Reported Event|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
11075399|NCT01444300|EG001|Reported Event|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
11075400|NCT01444378|BG000|Baseline|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
11075401|NCT01444378|FG000|Participant Flow|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
11075402|NCT01444378|OG000|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
11075403|NCT01444378|OG000|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
11075404|NCT01444378|OG001|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
11075405|NCT01444378|OG002|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
11075406|NCT01444378|EG000|Reported Event|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
11075407|NCT01444391|BG000|Baseline|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
11075408|NCT01444391|FG000|Participant Flow|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
11075409|NCT01444391|OG000|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
11075410|NCT01444391|EG000|Reported Event|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
11075411|NCT01444417|BG000|Baseline|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
11075412|NCT01444417|BG001|Baseline|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
11075413|NCT01444417|BG002|Baseline|Total|Total of all reporting groups
11075414|NCT01444417|FG000|Participant Flow|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
11075415|NCT01444417|FG001|Participant Flow|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
11075416|NCT01444417|OG000|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
11075417|NCT01444417|OG001|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
11075418|NCT01444417|EG000|Reported Event|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
11075419|NCT01444417|EG001|Reported Event|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
11075420|NCT01444430|BG000|Baseline|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
11075421|NCT01444430|BG001|Baseline|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
11075422|NCT01444430|BG002|Baseline|Total|Total of all reporting groups
11075423|NCT01444430|FG000|Participant Flow|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
11075424|NCT01444430|FG001|Participant Flow|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
11075425|NCT01444430|OG000|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
11075426|NCT01444430|OG001|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
11075427|NCT01444430|EG000|Reported Event|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
11075428|NCT01444430|EG001|Reported Event|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
11075429|NCT01444456|BG000|Baseline|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
11075430|NCT01444456|FG000|Participant Flow|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
11075431|NCT01444456|OG000|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
11075432|NCT01444456|EG000|Reported Event|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
11075433|NCT01444651|BG000|Baseline|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
11075434|NCT01444651|BG001|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
11075435|NCT01444651|BG002|Baseline|Total|Total of all reporting groups
11075436|NCT01444651|FG000|Participant Flow|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
11075437|NCT01444651|FG001|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
11075438|NCT01444651|OG000|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
11075439|NCT01444651|OG001|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
11075440|NCT01444651|EG000|Reported Event|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
11075441|NCT01444651|EG001|Reported Event|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
11075442|NCT01444716|BG000|Baseline|Treatment (Ofatumumab)|"Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.~Ofatumumab: Given IV"
11075443|NCT01444716|FG000|Participant Flow|Treatment (Ofatumumab)|"Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.~Ofatumumab: Given IV"
11075444|NCT01444716|OG000|Outcome|Treatment (Ofatumumab)|"Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.~Ofatumumab: Given IV"
11075445|NCT01444716|EG000|Reported Event|Treatment (Ofatumumab)|"Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.~Ofatumumab: Given IV"
11075446|NCT01444742|BG000|Baseline|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
10849883|NCT00299104|OG001|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
11075447|NCT01444742|FG000|Participant Flow|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
11075448|NCT01444742|OG000|Outcome|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
11075449|NCT01444742|EG000|Reported Event|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
11227382|NCT02382913|FG000|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11075450|NCT01444781|BG000|Baseline|DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
11075451|NCT01444781|BG001|Baseline|DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
11075452|NCT01444781|BG002|Baseline|Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group.|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
11075453|NCT01444781|BG003|Baseline|Total|Total of all reporting groups
11075454|NCT01444781|FG000|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
11227383|NCT02382913|FG001|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11075455|NCT01444781|FG001|Participant Flow|Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
11075456|NCT01444781|FG002|Participant Flow|Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
11075457|NCT01444781|OG000|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
11075458|NCT01444781|OG001|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
11075459|NCT01444781|OG002|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
11075460|NCT01444781|OG000|Outcome|Group 1: DTaP-IPV Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
11075461|NCT01444781|OG001|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
11075462|NCT01444781|OG002|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
11075463|NCT01444781|OG000|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
11075464|NCT01444781|OG001|Outcome|Group 2:DTaP-IPV-HepB PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
11075465|NCT01444781|OG000|Outcome|Group 1: DTaP-IPV-Hep B-PRP~ T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
11075466|NCT01444781|OG001|Outcome|Group 2: DTaP-IPV-HepB-PRP~Tprimary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
11075467|NCT01444781|EG000|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
11173597|NCT02016560|OG001|Outcome|Exploratory AB- (Amyloid Beta Negative)|Exploratory MCI or AD subjects with a negative florbetapir PET scan for amyloid
11075468|NCT01444781|EG001|Reported Event|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
11075469|NCT01444781|EG002|Reported Event|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
11075470|NCT01444898|BG000|Baseline|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
11075471|NCT01444898|FG000|Participant Flow|Exenatide|All subjects enrolled in this study will be given Exenatide for 6 months. The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
11075472|NCT01444898|OG000|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
11075473|NCT01444898|EG000|Reported Event|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
11075474|NCT01444911|BG000|Baseline|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
11075475|NCT01444911|BG001|Baseline|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
11075476|NCT01444911|BG002|Baseline|Total|Total of all reporting groups
11075477|NCT01444911|FG000|Participant Flow|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
11075478|NCT01444911|FG001|Participant Flow|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
11075479|NCT01444911|OG000|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
11075480|NCT01444911|OG001|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
11075481|NCT01444911|EG000|Reported Event|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
11075482|NCT01444911|EG001|Reported Event|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
11075483|NCT01444924|BG000|Baseline|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
11075484|NCT01444924|BG001|Baseline|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
11075485|NCT01444924|BG002|Baseline|Total|Total of all reporting groups
11075486|NCT01444924|FG000|Participant Flow|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
11075487|NCT01444924|FG001|Participant Flow|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
11075488|NCT01444924|OG000|Outcome|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
11075489|NCT01444924|OG001|Outcome|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
11075490|NCT01444924|EG000|Reported Event|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
11075491|NCT01444924|EG001|Reported Event|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
11075492|NCT01445028|BG000|Baseline|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
11075493|NCT01445028|BG001|Baseline|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
11075494|NCT01445028|BG002|Baseline|Total|Total of all reporting groups
11075495|NCT01445028|FG000|Participant Flow|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
11075496|NCT01445028|FG001|Participant Flow|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
11075497|NCT01445028|OG000|Outcome|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
11075498|NCT01445028|OG001|Outcome|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
11075499|NCT01445028|EG000|Reported Event|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
11075500|NCT01445028|EG001|Reported Event|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
11075501|NCT01445080|BG000|Baseline|Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2|Patients receive oral sorafenib 105 mg/m^2 every 12 hours
11075502|NCT01445080|BG001|Baseline|Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2|Patients receive oral sorafenib 130 mg/m^2 every 12 hours
11075503|NCT01445080|BG002|Baseline|Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours
11075504|NCT01445080|BG003|Baseline|Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours
11075505|NCT01445080|BG004|Baseline|Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2|Patients receive oral sorafenib 250 mg/m^2 every 12 hours
11075506|NCT01445080|BG005|Baseline|Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours
11075507|NCT01445080|BG006|Baseline|Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours
11075508|NCT01445080|BG007|Baseline|Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours
11075509|NCT01445080|BG008|Baseline|PK Cohort Expanded: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours
11075510|NCT01445080|BG009|Baseline|Total|Total of all reporting groups
11075511|NCT01445080|FG000|Participant Flow|Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2|Patients receive oral sorafenib 105 mg/m^2 every 12 hours.
11075512|NCT01445080|FG001|Participant Flow|Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2|Patients receive oral sorafenib 130 mg/m^2 every 12 hours.
11075513|NCT01445080|FG002|Participant Flow|Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075514|NCT01445080|FG003|Participant Flow|Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075515|NCT01445080|FG004|Participant Flow|Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2|Patients receive oral sorafenib 250 mg/m^2 every 12 hours.
11075516|NCT01445080|FG005|Participant Flow|Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075517|NCT01445080|FG006|Participant Flow|Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075518|NCT01445080|FG007|Participant Flow|Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075519|NCT01445080|FG008|Participant Flow|PK Cohort Expanded: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075520|NCT01445080|OG000|Outcome|Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2|Patients receive oral sorafenib 105 mg/m^2 every 12 hours.
11075521|NCT01445080|OG001|Outcome|Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2|Patients receive oral sorafenib 130 mg/m^2 every 12 hours.
11075522|NCT01445080|OG002|Outcome|Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075523|NCT01445080|OG003|Outcome|Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075524|NCT01445080|OG004|Outcome|Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2|Patients receive oral sorafenib 250 mg/m^2 every 12 hours.
11075525|NCT01445080|OG005|Outcome|Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075526|NCT01445080|OG006|Outcome|Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075527|NCT01445080|OG007|Outcome|Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075528|NCT01445080|OG008|Outcome|PK Cohort Expanded: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075529|NCT01445080|OG000|Outcome|STRATUM I (REFRACTORY SOLID TUMOR)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined, up to 6 additional patients under 12 years of age may be treated at the MTD. The MTD dose level is also expanded to enroll up to 6 patients with refractory leukemia.
11075530|NCT01445080|OG001|Outcome|STRATUM II (REFRACTORY LEUKEMIA)|A cohort of 3-6 patients with leukemia receives treatment as in stratum 1 at the MTD determined in stratum 1. If 2 of 3 or 2 of 6 patients experience a DLT at the solid tumor MTD, sorafenib is reduced by one dose level. The leukemia MTD is defined as the dose at which < 1/3 of patients experience DLT during course 1 of treatment
11075531|NCT01445080|OG000|Outcome|STARTUM I (REFRACTORY SOLID TUMORS)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined, up to 6 additional patients under 12 years of age may be treated at the MTD. The MTD dose level is also expanded to enroll up to 6 patients with refractory leukemia.
11075532|NCT01445080|OG001|Outcome|STRATUM II (REFRACTORY LEUKEMIA)|A cohort of 3-6 patients with leukemia receives treatment as in stratum 1 at the MTD determined in stratum 1. If 2 of 3 or 2 of 6 patients experience a DLT at the solid tumor MTD, sorafenib is reduced by one dose level. The leukemia MTD is defined as the dose at which < 1/3 of patients experience DLT during course 1 of treatment.
11075533|NCT01445080|OG000|Outcome|STRATUM I (REFRACTORY SOLID TUMOR|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined, up to 6 additional patients under 12 years of age may be treated at the MTD. The MTD dose level is also expanded to enroll up to 6 patients with refractory leukemia.
11227384|NCT02382913|FG002|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11075534|NCT01445080|OG001|Outcome|Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075535|NCT01445080|OG002|Outcome|Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075536|NCT01445080|OG003|Outcome|Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2|Patients receive oral sorafenib 250 mg/m^2 every 12 hours.
11075537|NCT01445080|OG004|Outcome|Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075538|NCT01445080|OG005|Outcome|Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075539|NCT01445080|OG006|Outcome|PK Cohort Expanded: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075540|NCT01445080|OG000|Outcome|STRATUM III (ACUTE MYELOID LEUKEMIA AND FLT3-ITD MUTATION)|Patients receive sorafenib as in stratum 1 at the MTD determined in stratum 2. Patients undergo blood sample collection for pharmacokinetics, pharmacodynamics (in leukemia blasts only), circulating endothelial cells (CEC), circulating CEC precursors (CECP), VEGF and VEGF-2 , gene expression, proteomic profile, ERK phosphorylation, and FLT3 phosphorylation activity. Tumor tissue samples may also be analyzed for the presence of ras, raf, or FLT3.
11075541|NCT01445080|OG002|Outcome|STRATUM III (ACUTE MYELOID LEUKEMIA AND FLT3-ITD MUTATION)|Patients receive sorafenib as in stratum 1 at the MTD determined in stratum 2. Patients undergo blood sample collection for pharmacokinetics, pharmacodynamics (in leukemia blasts only), circulating endothelial cells (CEC), circulating CEC precursors (CECP), VEGF and VEGF-2 , gene expression, proteomic profile, ERK phosphorylation, and FLT3 phosphorylation activity. Tumor tissue samples may also be analyzed for the presence of ras, raf, or FLT3.
11075542|NCT01445080|OG004|Outcome|PK Cohort Expanded: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075543|NCT01445080|OG000|Outcome|Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075544|NCT01445080|EG000|Reported Event|Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2|Patients receive oral sorafenib 105 mg/m^2 every 12 hours
11075545|NCT01445080|EG001|Reported Event|Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2|Patients receive oral sorafenib 130 mg/m^2 every 12 hours.
11075546|NCT01445080|EG002|Reported Event|Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075547|NCT01445080|EG003|Reported Event|Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 250 mg/m^2 every 12 hours.
11075548|NCT01445080|EG004|Reported Event|Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2|Patients receive oral sorafenib 250 mg/m^2 every 12 hours.
11075549|NCT01445080|EG005|Reported Event|Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075550|NCT01445080|EG006|Reported Event|Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075551|NCT01445080|EG007|Reported Event|Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2|Patients receive oral sorafenib 150 mg/m^2 every 12 hours.
11075552|NCT01445080|EG008|Reported Event|PK Cohort Expanded: BAY 43-9006 200 mg/m^2|Patients receive oral sorafenib 200 mg/m^2 every 12 hours.
11075553|NCT01445171|BG000|Baseline|INTUITY Aortic Valve and INTUITY Delivery System|The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
11075554|NCT01445171|FG000|Participant Flow|INTUITY Aortic Valve and INTUITY Delivery System|The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
11075555|NCT01445171|OG000|Outcome|INTUITY Aortic Valve and INTUITY Delivery System|The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
11075556|NCT01445171|OG000|Outcome|Baseline and 3 Months Follow-Up|The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
11075557|NCT01445171|OG001|Outcome|Baseline and 1 Year Follow-Up|The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
11075558|NCT01445171|EG000|Reported Event|INTUITY Aortic Valve and INTUITY Delivery System|The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
10887650|NCT00501995|EG000|Reported Event|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
11075559|NCT01445301|BG000|Baseline|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075560|NCT01445301|BG001|Baseline|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075561|NCT01445301|BG002|Baseline|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075562|NCT01445301|BG003|Baseline|Total|Total of all reporting groups
11075563|NCT01445301|FG000|Participant Flow|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 gram (g) containing clindamycin (CLDM) 10 milligram (mg) and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU (Finger Tip Unit).
11075564|NCT01445301|FG001|Participant Flow|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075565|NCT01445301|FG002|Participant Flow|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075566|NCT01445301|OG000|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075567|NCT01445301|OG001|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
10887651|NCT00502203|BG000|Baseline|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
11075568|NCT01445301|OG002|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075569|NCT01445301|EG000|Reported Event|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075570|NCT01445301|EG001|Reported Event|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075571|NCT01445301|EG002|Reported Event|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
11075572|NCT01445535|BG000|Baseline|Cohort 1 - 3.4 mg/kg|3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075573|NCT01445535|BG001|Baseline|Cohort 2 - 4.8 mg/kg|4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075574|NCT01445535|BG002|Baseline|Cohort 3 - 8.5 mg/kg|8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075575|NCT01445535|BG003|Baseline|Cohort 4 - 15 mg/kg|15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075576|NCT01445535|BG004|Baseline|Total|Total of all reporting groups
11075577|NCT01445535|FG000|Participant Flow|Cohort 1 - 3.4 mg/kg|3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075578|NCT01445535|FG001|Participant Flow|Cohort 2 - 4.8 mg/kg|4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075579|NCT01445535|FG002|Participant Flow|Cohort 3 - 8.5 mg/kg|8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075580|NCT01445535|FG003|Participant Flow|Cohort 4 - 15 mg/kg|15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075581|NCT01445535|OG000|Outcome|Cohort 1 - 3.4 mg/kg|3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075582|NCT01445535|OG001|Outcome|Cohort 2 - 4.8 mg/kg|4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075583|NCT01445535|OG002|Outcome|Cohort 3 - 8.5 mg/kg|8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075584|NCT01445535|OG003|Outcome|Cohort 4 - 15 mg/kg|15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075585|NCT01445535|OG000|Outcome|All Participants|All participants who received 3.4 mg/kg, 4.8 mg/kg, 8.5 mg/kg and 15 mg/kg siplizumab given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075586|NCT01445535|EG000|Reported Event|Cohort 1 - 3.4 mg/kg|3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075587|NCT01445535|EG001|Reported Event|Cohort 2 - 4.8 mg/kg|4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075588|NCT01445535|EG002|Reported Event|Cohort 3 - 8.5 mg/kg|8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075589|NCT01445535|EG003|Reported Event|Cohort 4 - 15 mg/kg|15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
11075590|NCT01445548|BG000|Baseline|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
11075591|NCT01445548|FG000|Participant Flow|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
11075592|NCT01445548|OG000|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
11075593|NCT01445548|EG000|Reported Event|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
11075594|NCT01445613|BG000|Baseline|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
11075595|NCT01445613|FG000|Participant Flow|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
11075596|NCT01445613|OG000|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
11075597|NCT01445613|OG000|Outcome|Composite of Peri-procedural DS in the Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or transient ischemic attack (TIA) (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
11075598|NCT01445613|OG001|Outcome|Composite of Peri-procedural DS in the Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
11075599|NCT01445613|OG000|Outcome|In Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or TIA (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
11075600|NCT01445613|OG001|Outcome|In Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
11075601|NCT01445613|OG000|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
11075602|NCT01445613|OG001|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
11075603|NCT01445613|EG000|Reported Event|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
11075604|NCT01445626|BG000|Baseline|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
11075605|NCT01445626|FG000|Participant Flow|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
11075606|NCT01445626|OG000|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
11075607|NCT01445626|EG000|Reported Event|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
11075608|NCT01445652|BG000|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
11075609|NCT01445652|BG001|Baseline|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
11075610|NCT01445652|BG002|Baseline|Total|Total of all reporting groups
11075611|NCT01445652|FG000|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
11075612|NCT01445652|FG001|Participant Flow|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
11075613|NCT01445652|OG000|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
11075614|NCT01445652|OG001|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
11075615|NCT01445652|EG000|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
11075616|NCT01445652|EG001|Reported Event|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
11075617|NCT01445678|BG000|Baseline|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
11075618|NCT01445678|BG001|Baseline|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
11075619|NCT01445678|BG002|Baseline|Total|Total of all reporting groups
11075620|NCT01445678|FG000|Participant Flow|CXA-201 and Metronidazole as Treatment for cIAI|"CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days.~Of the 979 treated subjects in the integrated analysis set, 482 received CXA."
11075621|NCT01445678|FG001|Participant Flow|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days Of the 979 treated subjects in the integrated analysis set, 497 received meropenem.
11075622|NCT01445678|OG000|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
11075623|NCT01445678|OG001|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
11075624|NCT01445678|EG000|Reported Event|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
11075625|NCT01445678|EG001|Reported Event|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
11075626|NCT01445730|BG000|Baseline|After Fructose Feeding|After 3 month fructose diet 75 g/day
11075627|NCT01445730|FG000|Participant Flow|After Fructose Feeding|After 3 month fructose diet 75 g/day
11075628|NCT01445730|OG000|Outcome|After Fructose Feeding|After 3 month fructose diet 75 g/day
11075629|NCT01445730|EG000|Reported Event|After Fructose Feeding|After 3 month fructose diet 75 g/day
11075630|NCT01445769|BG000|Baseline|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
11075631|NCT01445769|FG000|Participant Flow|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported Patients' Global Impression of Change (PGIC) score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
11075632|NCT01445769|OG000|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
11075633|NCT01445769|OG000|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
11075634|NCT01445769|OG000|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
11075635|NCT01445769|EG000|Reported Event|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
11075636|NCT01445821|BG000|Baseline|Cyclophosphamide rATG/HSCT|"Conditioning regimen: 200 mg/kg of intravenous cyclophosphamide given in 4 equal fractions on days -5 through -2 with intravenous mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Methylprednisolone 1000 mg will be used infused intravenously before each dose of rATG. Peripheral blood stem cells (PBSC) will be infused intravenously on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: An alkylating agent~Mesna: Used to decrease the risk of hemorrhagic cystitis~rATG: Immunosuppressive agent which contains antibodies specific to the antigens~Methylprednisolone: Steroid~Filgrastim: Granulocyte-colony stimulating factor (G-CSF); a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells"
11075637|NCT01445821|BG001|Baseline|Cyclophosphamide rATG/Fludarabine/HSCT|"Conditioning regimen: 120 mg/kg of IV cyclophosphamide given in 2 equal fractions on days -3 and -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Fludarabine 30 mg/m2 will be given IV on days -5, -4, and -3. Methylprednisolone 1000 mg will be used infused IV before each dose of rATG. PBSC will be infused IV on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and cont. until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: Alkylating agent~Mesna: Used to decrease the risk of hemorrhagic cystitis~rATG: Immunosuppressive agent which contains antibodies specific to the antigens~Methylprednisolone: Steroid~Filgrastim: Granulocyte-colony stimulating factor (G-CSF);glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells~Fludarabine: Purine analog which inhibits DNA synthesis/repair"
11075638|NCT01445821|BG002|Baseline|Total|Total of all reporting groups
11075639|NCT01445821|FG000|Participant Flow|Cyclophosphamide rATG/HSCT|"Conditioning regimen will be 200 mg/kg of intravenous cyclophosphamide given in 4 equal fractions on days -5 through -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Methylprednisolone 1000 mg will be used infused intravenously before each dose of rATG. Peripheral blood stem cells (PBSC) will be infused intravenously on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: Alkylating agent~Mesna: Used to decrease the risk of hemorrhagic cystitis~rATG: Immunosuppressive agent which contains antibodies specific to the antigens~Methylprednisolone: Steroid~Filgrastim: Granulocyte-colony stimulating factor (G-CSF); a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells"
11075640|NCT01445821|FG001|Participant Flow|Cyclophosphamide rATG/Fludarabine/HSCT|"Conditioning regimen will be 120 mg/kg of IV cyclophosphamide given in 2 equal fractions on days -3 and -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 then 1.5 mg/kg from day-4 thru day -1. Fludarabine 30 mg/m2 will be given IV on days -5, -4, and -3. Methylprednisolone 1000 mg will be used infused IV before each dose of rATG. PBSC will be infused IV on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and cont. until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: Alkylating agent~Mesna: Used to decrease the risk of hemorrhagic cystitis~rATG: Immunosuppressive agent which contains antibodies specific to the antigens~Methylprednisolone: Steroid~Filgrastim: Granulocyte-colony stimulating factor (G-CSF);glycoprotein that stimulates the bone marrow to produce granulocytes/stem cells~Fludarabine: Purine analog which inhibits DNA synthesis/repair"
11075641|NCT01445821|OG000|Outcome|Cyclophosphamide rATG/HSCT|"Conditioning regimen will be 200 mg/kg of intravenous cyclophosphamide given in 4 equal fractions on days -5 through -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Methylprednisolone 1000 mg will be used infused intravenously before each dose of rATG. Peripheral blood stem cells (PBSC) will be infused intravenously on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: Alkylating agent~Mesna: Used to decrease the risk of hemorrhagic cystitis~rATG: Immunosuppressive agent which contains antibodies specific to the antigens~Methylprednisolone: Steroid~Filgrastim: Granulocyte-colony stimulating factor (G-CSF); a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells"
11075642|NCT01445821|OG001|Outcome|Cyclophosphamide rATG/Fludarabine/HSCT|"Conditioning regimen will be 120 mg/kg of intravenous cyclophosphamide given in 2 equal fractions on days -3 and -2 with intravenous mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Fludarabine 30 mg/m2 will be given IV on days -5, -4, and -3. Methylprednisolone 1000 mg will be used infused intravenously before each dose of rATG. PBSC will be infused intravenously on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: An alkylating agent which causes prevention of cell division by forming adducts with DNA~Mesna: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis~rATG: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells~Methylpredni"
11075643|NCT01445821|EG000|Reported Event|Cyclophosphamide rATG/HSCT|"Control arm will have the same conditioning regimen used in ASSIST study. The conditioning regimen will be 200 mg/kg of intravenous cyclophosphamide given in 4 equal fractions on days -5 through -2 with intravenous mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Methylprednisolone 1000 mg will be used infused intravenously before each dose of rATG. Peripheral blood stem cells (PBSC) will be infused intravenously on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: An alkylating agent which causes prevention of cell division by forming adducts with DNA~Mesna: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis~rATG: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonl"
11075644|NCT01445821|EG001|Reported Event|Cyclophosphamide rATG/Fludarabine/HSCT|"Conditioning regimen will be 120 mg/kg of IV cyclophosphamide given in 2 equal fractions on days -3 and -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 then 1.5 mg/kg from day-4 thru day -1. Fludarabine 30 mg/m2 will be given IV on days -5, -4, and -3. Methylprednisolone 1000 mg will be used infused IV before each dose of rATG. PBSC will be infused IV on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and cont. until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: Alkylating agent~Mesna: Used to decrease the risk of hemorrhagic cystitis~rATG: Immunosuppressive agent which contains antibodies specific to the antigens~Methylprednisolone: Steroid~Filgrastim: Granulocyte-colony stimulating factor (G-CSF);glycoprotein that stimulates the bone marrow to produce granulocytes/stem cells~Fludarabine: Purine analog which inhibits DNA synthesis/repair"
11075645|NCT01445847|BG000|Baseline|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
11075646|NCT01445847|BG001|Baseline|Placebo|Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued
11075647|NCT01445847|BG002|Baseline|Total|Total of all reporting groups
11075648|NCT01445847|FG000|Participant Flow|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
11075649|NCT01445847|FG001|Participant Flow|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
11075650|NCT01445847|OG000|Outcome|Lidocaine|Lidocaine group received 1 mg per kg (1mL per 10kg) bolus once inhalational gas (Desflurane) is discontinued
11075651|NCT01445847|OG001|Outcome|Placebo|Placebo group received 1 ml per 10 kg (0.2 mL per 2 kg) bolus once inhalational gas (Desflurane) is discontinued
11075652|NCT01445847|EG000|Reported Event|Lidocaine|Lidocaine group received 1 ml/10 kg (or 1mg/kg) bolus once inhalational gas (Desflurane) is discontinued
11075653|NCT01445847|EG001|Reported Event|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
11075654|NCT01445873|BG000|Baseline|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
11075655|NCT01445873|FG000|Participant Flow|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
11075656|NCT01445873|OG000|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
11075657|NCT01445873|EG000|Reported Event|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
10887652|NCT00502203|FG000|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
10887653|NCT00502203|OG000|Outcome|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
11075658|NCT01445886|BG000|Baseline|Indigo Naturalis Extract in Oil VS Calcipotriol|Patients were instructed to apply Lindioil (indigo naturalis extract in oil) to the fingernails of one hand (experimental group) and calcipotriol solution to the fingernails of the other hand (control group) twice daily for 24 weeks.
11075659|NCT01445886|FG000|Participant Flow|Indigo Naturalis Extract in Oil VS Calcipotriol|Patients were instructed to apply Lindioil (indigo naturalis extract in oil) to the fingernails of one hand (experimental group) and calcipotriol solution to the fingernails of the other hand (control group) twice daily for 24 weeks.
11075660|NCT01445886|OG000|Outcome|Indigo Naturalis Oil Extract|Indigo Naturalis Oil Extract: The participants applied indigo naturalis oil extract topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
11075661|NCT01445886|OG001|Outcome|Calcipotriol Solution|Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
11075662|NCT01445886|EG000|Reported Event|Indigo Naturalis Oil Extract|Indigo Naturalis Oil Extract: The participants applied indigo naturalis oil extract topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
11075663|NCT01445886|EG001|Reported Event|Calcipotriol Solution|Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
11075664|NCT01445951|BG000|Baseline|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
11075665|NCT01445951|BG001|Baseline|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
11075666|NCT01445951|BG002|Baseline|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
11075667|NCT01445951|BG003|Baseline|Total|Total of all reporting groups
11075668|NCT01445951|FG000|Participant Flow|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
11075669|NCT01445951|FG001|Participant Flow|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
11075670|NCT01445951|FG002|Participant Flow|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
11075671|NCT01445951|OG000|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
11075672|NCT01445951|OG001|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
11075673|NCT01445951|OG002|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
11075674|NCT01445951|EG000|Reported Event|Technosphere ® Insulin-Gen2 Group|"Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry~Technosphere ®Insulin with Gen2 Inhaler: Inhalation Powder and injectable insulin"
11075675|NCT01445951|EG001|Reported Event|Technosphere® Insulin With MedTone C Inhaler|"Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry~Technosphere® Insulin with MedTone C Inhaler: Inhalation Powder and injectable insulin"
11075676|NCT01445951|EG002|Reported Event|Aspart Group|"Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry~Insulin Aspart in combination with a basal insulin: Injectable insulin"
11075677|NCT01446003|BG000|Baseline|All Participants|
11075678|NCT01446003|FG000|Participant Flow|MK-8457-Placebo Sequence|Participants received MK-8457 100 mg twice daily (BID) for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
11075679|NCT01446003|FG001|Participant Flow|Placebo-MK-8457 Sequence|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
11075680|NCT01446003|OG000|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
11075681|NCT01446003|OG001|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
11075682|NCT01446003|EG000|Reported Event|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
11075683|NCT01446003|EG001|Reported Event|Placebo|Participants received Placebo for MK-8457 for 10 days
11075684|NCT01446042|BG000|Baseline|TBS-1 - b.i.d.|Intranasal testosterone given b.i.d.
11075685|NCT01446042|BG001|Baseline|TBS-1 - b.i.d./t.i.d.|Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
11075686|NCT01446042|BG002|Baseline|TBS-1 - t.i.d.|Intranasal testosterone given t.i.d.
11075687|NCT01446042|BG003|Baseline|Total|Total of all reporting groups
11075688|NCT01446042|FG000|Participant Flow|TBS-1 - b.i.d.|Intranasal testosterone given b.i.d.
11075689|NCT01446042|FG001|Participant Flow|TBS-1 b.i.d./t.i.d|Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
11075690|NCT01446042|FG002|Participant Flow|TBS-1 - t.i.d.|Intranasal testosterone given t.i.d.
11075691|NCT01446042|OG000|Outcome|TBS-1 - b.i.d.|"5.5 mg per nostril of 4.5% TBS-1 BID~Testosterone: Intranasal testosterone"
11075692|NCT01446042|OG001|Outcome|TBS-1 - b.i.d./t.i.d.|Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
11075693|NCT01446042|OG002|Outcome|TBS-1 - t.i.d.|"5.5 mg per nostril of 4.5% TBS-1 TID~Testosterone: Intranasal testosterone"
11075694|NCT01446042|EG000|Reported Event|TBS-1 - b.i.d.|Intranasal testosterone given b.i.d.
11075695|NCT01446042|EG001|Reported Event|TBS-1 - b.i.d./t.i.d.|Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
11075696|NCT01446042|EG002|Reported Event|TBS-1 - t.i.d.|Intranasal testosterone given t.i.d.
11173598|NCT02016560|OG000|Outcome|Independent Readers|Scans were interpreted by 5 imaging physicians, blind to clinical data, after training by an Avid expert.
11150286|NCT01876901|BG000|Baseline|2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA)|"Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.~2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.~After surgical resection, the colon is exteriorized through the anus and attached to the buttock.~By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation"
11150287|NCT01876901|BG001|Baseline|Colo-anal Anastomosis (CAA)|"Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.~Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.~In the absence of fistula, the patient will reoperation for stoma closure of its branch"
11150288|NCT01876901|BG002|Baseline|Total|Total of all reporting groups
11150289|NCT01876901|FG000|Participant Flow|2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA)|"Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.~2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.~After surgical resection, the colon is exteriorized through the anus and attached to the buttock.~By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation"
11150290|NCT01876901|FG001|Participant Flow|Colo-anal Anastomosis (CAA)|"Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.~Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.~In the absence of fistula, the patient will reoperation for stoma closure of its branch"
11150291|NCT01876901|OG000|Outcome|2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA)|"Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.~2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.~After surgical resection, the colon is exteriorized through the anus and attached to the buttock.~By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation"
11150292|NCT01876901|OG001|Outcome|Colo-anal Anastomosis (CAA)|"Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.~Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.~In the absence of fistula, the patient will reoperation for stoma closure of its branch"
11150293|NCT01876901|OG000|Outcome|Colo-anal Anastomosis (CAA)|"Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.~Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.~In the absence of fistula, the patient will reoperation for stoma closure of its branch."
11150294|NCT01876901|EG000|Reported Event|2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA)|"Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.~2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.~After surgical resection, the colon is exteriorized through the anus and attached to the buttock.~By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation"
11150295|NCT01876901|EG001|Reported Event|Colo-anal Anastomosis (CAA)|"Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.~Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.~In the absence of fistula, the patient will reoperation for stoma closure of its branch"
11150296|NCT01876979|BG000|Baseline|Intermaxillary Fixation Screws|"Use of Intermaxillary Fixation screws as a means to wire the jaws.~IMF Screws: stainless steel screws placed in bone"
11150297|NCT01876979|BG001|Baseline|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.~Erich Arch Bars: Surgical braces wired around teeth"
11150298|NCT01876979|BG002|Baseline|Total|Total of all reporting groups
11150299|NCT01876979|FG000|Participant Flow|IMF Screws|"Use of IMF screws as a means to wire the jaws.~IMF Screws: stainless steel screws placed in bone"
11150300|NCT01876979|FG001|Participant Flow|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.~Erich Arch Bars: Surgical braces wired around teeth"
11150301|NCT01876979|OG000|Outcome|IMF Screws|"Use of IMF screws as a means to wire the jaws.~IMF Screws: stainless steel screws placed in bone"
11150302|NCT01876979|OG001|Outcome|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.~Erich Arch Bars: Surgical braces wired around teeth"
11150303|NCT01876979|EG000|Reported Event|IMF Screws|"Use of IMF screws as a means to wire the jaws.~IMF Screws: stainless steel screws placed in bone"
11150304|NCT01876979|EG001|Reported Event|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.~Erich Arch Bars: Surgical braces wired around teeth"
11173599|NCT02016560|OG000|Outcome|Exploratory Young Cognitively Healthy Subjects|Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29
11075697|NCT01446159|BG000|Baseline|MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)|Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075698|NCT01446159|BG001|Baseline|MEDI-573 30 mg/kg + AI|Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075699|NCT01446159|BG002|Baseline|MEDI-573 45 mg/kg + AI|Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
11075700|NCT01446159|BG003|Baseline|Aromatase Inhibitor|Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075701|NCT01446159|BG004|Baseline|Total|Total of all reporting groups
11075702|NCT01446159|FG000|Participant Flow|MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)|Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075703|NCT01446159|FG001|Participant Flow|MEDI-573 30 mg/kg + AI|Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075704|NCT01446159|FG002|Participant Flow|MEDI-573 45 mg/kg + AI|Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
11075705|NCT01446159|FG003|Participant Flow|Aromatase Inhibitor|Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075706|NCT01446159|OG000|Outcome|MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)|Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075707|NCT01446159|OG001|Outcome|MEDI-573 30 mg/kg + AI|Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075708|NCT01446159|OG002|Outcome|MEDI-573 45 mg/kg + AI|Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
11075709|NCT01446159|OG003|Outcome|Aromatase Inhibitor|Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075710|NCT01446159|OG000|Outcome|MEDI-573 45 mg/kg + AI|Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
11075711|NCT01446159|OG001|Outcome|Aromatase Inhibitor|Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075712|NCT01446159|EG000|Reported Event|MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)|Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075713|NCT01446159|EG001|Reported Event|MEDI-573 30 mg/kg + AI|Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075714|NCT01446159|EG002|Reported Event|MEDI-573 45 mg/kg + AI|Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
11075715|NCT01446159|EG003|Reported Event|Aromatase Inhibitor|Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
11075716|NCT01446237|BG000|Baseline|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
11173600|NCT02016560|OG001|Outcome|Exploratory Older Cognitively Healthy Subjects 50-59|Male or female subjects 50-59 years of age with MMSE ≥29
11173601|NCT02016560|OG002|Outcome|Exploratory Older Cognitively Healthy Subjects 60-69|Male or female subjects 60-69 years of age with MMSE ≥29
11075717|NCT01446237|FG000|Participant Flow|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (Benzoyl Peroxide[BPO]) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 percent salicylic acid [SA]) each evening over an application period of 12 weeks.
11075718|NCT01446237|OG000|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
11075719|NCT01446237|EG000|Reported Event|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
11075720|NCT01446289|BG000|Baseline|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
11075721|NCT01446289|BG001|Baseline|Mothers Placebo|Pregnant women who received one injection of saline solution.
11075722|NCT01446289|BG002|Baseline|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
11075723|NCT01446289|BG003|Baseline|Infants Placebo|Infants born from mothers who received one injection of saline solution.
11075724|NCT01446289|BG004|Baseline|Total|Total of all reporting groups
11075725|NCT01446289|FG000|Participant Flow|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
11075726|NCT01446289|FG001|Participant Flow|Mothers Placebo|Pregnant women who received one injection of saline solution.
10887654|NCT00502203|EG000|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
10887655|NCT00502216|BG000|Baseline|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
11075727|NCT01446289|FG002|Participant Flow|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
11075728|NCT01446289|FG003|Participant Flow|Infants Placebo|Infants born from mothers who received one injection of saline solution.
11075729|NCT01446289|OG000|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
11075730|NCT01446289|OG001|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
11075731|NCT01446289|OG002|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
11075732|NCT01446289|OG003|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
11075733|NCT01446289|OG000|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
11075734|NCT01446289|OG001|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
11075735|NCT01446289|EG000|Reported Event|Mothers GBS|Pregnant women who received one dose of GBS vaccine.
11075736|NCT01446289|EG001|Reported Event|Mothers Placebo|Pregnant women who received one injection of saline solution.
11075737|NCT01446289|EG002|Reported Event|Infants GBS|Infants born from mothers who received one dose of GBS vaccine.
11075738|NCT01446289|EG003|Reported Event|Infants Placebo|Infants born from mothers who received one injection of saline solution.
11075739|NCT01446419|BG000|Baseline|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
11075740|NCT01446419|BG001|Baseline|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
11075741|NCT01446419|BG002|Baseline|Total|Total of all reporting groups
11075742|NCT01446419|FG000|Participant Flow|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
11075743|NCT01446419|FG001|Participant Flow|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
11075744|NCT01446419|OG000|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
11075745|NCT01446419|OG001|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
11075746|NCT01446419|EG000|Reported Event|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
11075747|NCT01446419|EG001|Reported Event|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
11075748|NCT01446666|BG000|Baseline|US+MRI|The patients were evaluated by three rounds of screening tests with paired US and gadoxetic acid-enhanced MRI at 6-month intervals.
11075749|NCT01446666|FG000|Participant Flow|US+MRI|The patients were evaluated by three rounds of screening tests with paired US and gadoxetic acid-enhanced MRI at 6-month intervals
11075750|NCT01446666|OG000|Outcome|Ultasonography|Results from ultrasonography
11075751|NCT01446666|OG001|Outcome|Gadoxetic Acid-enhanced MRI|Results from Gadoxetic acid-enhanced MRI
11075752|NCT01446666|EG000|Reported Event|US+MRI|The patients were evaluated by three rounds of screening tests with paired US and gadoxetic acid-enhanced MRI at 6-month intervals
11075753|NCT01446705|BG000|Baseline|Controls in Study (Not Enrolled in Health Care Exchange)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
11075754|NCT01446705|BG001|Baseline|Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
11075755|NCT01446705|BG002|Baseline|Total|Total of all reporting groups
11075756|NCT01446705|FG000|Participant Flow|Controls in Study (Not Enrolled in Health Care Exchange)|Patients in this arm will represent Veterans seen at the Indianapolis VA Medical Center (VAMC) for whom information exchange has not been activated.
11075757|NCT01446705|FG001|Participant Flow|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
11075758|NCT01446705|OG000|Outcome|Controls in Study (Not Enrolled in Health Care Exchange)|Patients in this group were not enrolled in Health Information Exchange.
11075759|NCT01446705|OG001|Outcome|Enrolled in HIE|This group represents veterans were enrolled in Health Information Exchange via VLER
11075760|NCT01446705|OG000|Outcome|Controls in Study (Not Enrolled in Health Care Exchange)|Patients in this arm represent Veterans seen at the Indianapolis VAMC NOT enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
11075761|NCT01446705|OG001|Outcome|Enrolled in HIE|Patients in this arm represent Veterans seen at the Indianapolis VAMC enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
11075762|NCT01446705|OG000|Outcome|Control Prior to Intervention|Subjects not exposed to HIE prior to intervention
11075763|NCT01446705|OG001|Outcome|Enrolled Prior to Intervention|Subjects enrolled in HIE prior to intervention
11075764|NCT01446705|OG002|Outcome|Controls Post Intervention|Not enrolled in HIE post intervention
11075765|NCT01446705|OG003|Outcome|Enrolled Post Intervention|Those participating in HIE post intervention
11075766|NCT01446705|OG000|Outcome|Pre-Intervention Control|Control subjects prior to intervention.
11075767|NCT01446705|OG001|Outcome|Pre-Intervention Cases|Intervention subject prior to intervention
11075768|NCT01446705|OG002|Outcome|Post-Intervention Control|Control subjects after intervention.
11075769|NCT01446705|OG003|Outcome|Post -Intervention Cases|Intervention subject after intervention
11075770|NCT01446705|EG000|Reported Event|Controls in Study (Not Enrolled in Health Care Exchange)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
11075771|NCT01446705|EG001|Reported Event|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
11075772|NCT01446809|BG000|Baseline|Pazopanib|"Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery"
11075773|NCT01446809|BG001|Baseline|Placebo|"Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery"
11075774|NCT01446809|BG002|Baseline|Total|Total of all reporting groups
11075775|NCT01446809|FG000|Participant Flow|Pazopanib|"Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery"
11075776|NCT01446809|FG001|Participant Flow|Placebo|"Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery"
11075777|NCT01446809|FG002|Participant Flow|Blinded|Patients receive pazopanib hydrochloride or placebo PO QD. Patient did not complete study and thus treatment arm remains blinded.
11075778|NCT01446809|OG000|Outcome|Pazopanib|"Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery"
11075779|NCT01446809|OG001|Outcome|Placebo|"Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery"
11075780|NCT01446809|OG000|Outcome|Arm I (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV~External Beam Radiation Therapy: Undergo external beam radiation therapy~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11075781|NCT01446809|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV~External Beam Radiation Therapy: Undergo external beam radiation therapy~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO~Therapeutic Conventional Surgery: Undergo surgery"
11075782|NCT01446809|EG000|Reported Event|Pazopanib|"Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery"
11173602|NCT02016560|OG003|Outcome|Exploratory Older Cognitively Healthy Subjects 70-79|Male or female subjects 70-79 years of age with MMSE ≥29
11173603|NCT02016560|OG004|Outcome|Exploratory Older Cognitively Healthy Subjects >=80|Male or female subjects 80 years of age or older with MMSE ≥29
11075783|NCT01446809|EG001|Reported Event|Placebo|"Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery"
11075784|NCT01446809|EG002|Reported Event|Blinded|Patients receive pazopanib hydrochloride or placebo PO QD. Patient did not complete study and thus treatment arm remains blinded.
11075785|NCT01446874|BG000|Baseline|Pre-operative Brushing (Pilot Portion)|-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
11075786|NCT01446874|BG001|Baseline|Pre-operative & Post-Operative Brushing (Esophageal Resection)|"Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution~The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group."
11075787|NCT01446874|BG002|Baseline|Pre-operative & Post-Operative Brushing (Lung Resection)|"Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution~The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group."
11075788|NCT01446874|BG003|Baseline|Total|Total of all reporting groups
11075789|NCT01446874|FG000|Participant Flow|Pre-operative Brushing (Pilot Portion)|-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
11075790|NCT01446874|FG001|Participant Flow|Pre & Post Operative Brushing (Esophageal Resection)|"Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution~The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group."
11075791|NCT01446874|FG002|Participant Flow|Pre & Post Operative Brushing (Lung Resection)|"Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution~The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group."
11075792|NCT01446874|OG000|Outcome|Pre-operative Brushing (Pilot Portion)|-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
11075793|NCT01446874|OG001|Outcome|Pre-operative & Post-Operative Brushing (Esophageal Resection)|"Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution~The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group."
11075794|NCT01446874|OG002|Outcome|Pre-operative & Post-Operative Brushing (Lung Resection)|"Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution~The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group."
11075795|NCT01446874|EG000|Reported Event|Pre-operative Brushing (Pilot Portion)|-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
11075796|NCT01446874|EG001|Reported Event|Pre-operative & Post-Operative Brushing (Esophageal Resection)|"Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution~The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group."
11075797|NCT01446874|EG002|Reported Event|Pre-operative & Post-Operative Brushing (Lung Resection)|"Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution~The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group."
11075798|NCT01446913|BG000|Baseline|Standard Intervention Group|"This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support.~Standard CPAP Intervention"
11075799|NCT01446913|BG001|Baseline|Enhanced CPAP Intervention|"This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.~Enhanced CPAP Intervention"
11075800|NCT01446913|BG002|Baseline|Usual Care|This group usual care after TIA/stroke and a sleep study at the end of the study.
11075801|NCT01446913|BG003|Baseline|Total|Total of all reporting groups
11075802|NCT01446913|FG000|Participant Flow|Standard Intervention Group|"This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support.~Standard CPAP Intervention"
11075803|NCT01446913|FG001|Participant Flow|Enhanced CPAP Intervention|"This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.~Enhanced CPAP Intervention"
11075804|NCT01446913|FG002|Participant Flow|Usual Care|This group usual care after TIA/stroke and a sleep study at the end of the study.
11075805|NCT01446913|OG000|Outcome|Standard Intervention Group|"This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support.~Standard CPAP Intervention"
11075806|NCT01446913|OG001|Outcome|Enhanced CPAP Intervention|"This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.~Enhanced CPAP Intervention"
11075807|NCT01446913|OG002|Outcome|Usual Care|This group usual care after TIA/stroke and a sleep study at the end of the study.
11075808|NCT01446913|OG000|Outcome|Standard|Standard Intervention patients with a diagnosis of sleep apnea.
11075809|NCT01446913|OG001|Outcome|Enhanced|Enhanced Intervention patients with a diagnosis of sleep apnea.
11075810|NCT01446913|OG000|Outcome|No CPAP Use|Intervention and control patients with none/poor CPAP use
11075811|NCT01446913|OG001|Outcome|Some CPAP Use|Intervention patients with some CPAP (less than 4 hours per night)
11075812|NCT01446913|OG002|Outcome|Good CPAP Use|Intervention patients with good CPAP use (>=4 hours per night)
11075813|NCT01446913|OG000|Outcome|No CPAP Use|Intervention and control patients with none/poor CPAP use.
11075814|NCT01446913|EG000|Reported Event|Standard Intervention Group|"This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support.~Standard CPAP Intervention"
11075815|NCT01446913|EG001|Reported Event|Enhanced CPAP Intervention|"This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.~Enhanced CPAP Intervention"
11075816|NCT01446913|EG002|Reported Event|Usual Care|This group usual care after TIA/stroke and a sleep study at the end of the study.
11075817|NCT01446965|BG000|Baseline|Wearable Defibrillator|"subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients~wearable defibrillator: LifeVest wearable defibrillator"
11075818|NCT01446965|BG001|Baseline|Conventional Treatment|subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
11075819|NCT01446965|BG002|Baseline|Total|Total of all reporting groups
11075820|NCT01446965|FG000|Participant Flow|Wearable Defibrillator|"subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (WCD) (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients~wearable defibrillator: LifeVest wearable defibrillator"
11075821|NCT01446965|FG001|Participant Flow|Conventional Treatment|subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
11075822|NCT01446965|OG000|Outcome|Wearable Defibrillator|"subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients~wearable defibrillator: LifeVest wearable defibrillator"
11075823|NCT01446965|OG001|Outcome|Conventional Treatment|subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
11075824|NCT01446965|EG000|Reported Event|Wearable Defibrillator|"subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients~wearable defibrillator: LifeVest wearable defibrillator"
11075825|NCT01446965|EG001|Reported Event|Conventional Treatment|subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
11075826|NCT01447017|BG000|Baseline|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
11075827|NCT01447017|BG001|Baseline|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
11075828|NCT01447017|BG002|Baseline|Total|Total of all reporting groups
11075829|NCT01447017|FG000|Participant Flow|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
11075830|NCT01447017|FG001|Participant Flow|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
11075831|NCT01447017|OG000|Outcome|DPK-060 2% Ear Drops|Patients randomized to treatment with DPK-060 2% ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
11075832|NCT01447017|OG001|Outcome|Placebo for DPK-060 Ear Drops|Patients randomized to treatment with Placebo for DPK-060 ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
11075833|NCT01447017|EG000|Reported Event|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
11075834|NCT01447017|EG001|Reported Event|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
11075835|NCT01447121|BG000|Baseline|Intended Users of the System|Study results from 2 subjects were excluded from all data analysis, because study staff inadvertently performed study tasks that could be considered 'training' them. (According to protocol, training was not allowed.)
11075836|NCT01447121|FG000|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
11075837|NCT01447121|OG000|Outcome|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
11075838|NCT01447121|OG000|Outcome|Study Staff|Study staff also used the investigational Blood Glucose Monitoring System (BGMS) (Tatus/Tradewind Investigational Blood Glucose Meter)
11075839|NCT01447121|EG000|Reported Event|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
11075840|NCT01447225|BG000|Baseline|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
11075841|NCT01447225|BG001|Baseline|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
11075842|NCT01447225|BG002|Baseline|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
11075843|NCT01447225|BG003|Baseline|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
11075844|NCT01447225|BG004|Baseline|Total|Total of all reporting groups
11075845|NCT01447225|FG000|Participant Flow|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
11075846|NCT01447225|FG001|Participant Flow|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
11075847|NCT01447225|FG002|Participant Flow|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
11075848|NCT01447225|FG003|Participant Flow|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
11075849|NCT01447225|FG004|Participant Flow|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
11075850|NCT01447225|FG005|Participant Flow|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
11075851|NCT01447225|FG006|Participant Flow|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
11075852|NCT01447225|FG007|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
11075853|NCT01447225|FG008|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
11075854|NCT01447225|FG009|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
11075855|NCT01447225|OG000|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
11075856|NCT01447225|OG001|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
11075857|NCT01447225|OG002|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
11075858|NCT01447225|OG003|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
11075859|NCT01447225|OG004|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
11075860|NCT01447225|OG005|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
11075861|NCT01447225|OG006|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
11075862|NCT01447225|OG007|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
11075863|NCT01447225|OG008|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
11075864|NCT01447225|OG009|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
11075865|NCT01447225|OG000|Outcome|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Gemcitabine: administered IV at 1000 mg/m2 or 1250 mg/m2"
11075866|NCT01447225|OG001|Outcome|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
11075867|NCT01447225|OG002|Outcome|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
11075868|NCT01447225|OG003|Outcome|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
11075869|NCT01447225|OG000|Outcome|MM-121 + Gemcitabine|
11075870|NCT01447225|OG000|Outcome|MM-121 + Carboplatin|MTD of the MM-121 + Carboplatin combination NOTE: MTD of MM-121 for this combination provided in separate endpoint
11075871|NCT01447225|OG000|Outcome|MM-121 + Pemetrexed|MTD of combination of MM-121 + Pemetrexed - NOTE: MTD of MM-121 for this combination provided in separate endpoint
11075872|NCT01447225|OG000|Outcome|MM-121 + Cabazitaxel|MTD of MM-121 + Cabazitaxel combination - NOTE: MTD of MM-121 for this combination provided in separate endpoint
11075873|NCT01447225|OG000|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
11075874|NCT01447225|OG001|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
11075875|NCT01447225|OG002|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
11075876|NCT01447225|OG003|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
11075877|NCT01447225|OG004|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
11075878|NCT01447225|OG005|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
11075879|NCT01447225|OG006|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
11075880|NCT01447225|OG007|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
11075881|NCT01447225|EG000|Reported Event|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
11075882|NCT01447225|EG001|Reported Event|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
11075883|NCT01447225|EG002|Reported Event|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
11075884|NCT01447225|EG003|Reported Event|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
11075885|NCT01447407|BG000|Baseline|NDV-3 Vaccine With Alum|NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
11075886|NCT01447407|BG001|Baseline|NDV-3 Vaccine Without Alum|NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
11075887|NCT01447407|BG002|Baseline|Placebo|Placebo administered ID: One dose saline placebo administered ID
11075888|NCT01447407|BG003|Baseline|NDV-3 Vaccine ID|NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
11075889|NCT01447407|BG004|Baseline|Total|Total of all reporting groups
11075890|NCT01447407|FG000|Participant Flow|NDV-3 Vaccine With Alum|NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
11075891|NCT01447407|FG001|Participant Flow|NDV-3 Vaccine Without Alum|NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
11075892|NCT01447407|FG002|Participant Flow|Placebo|Placebo administered ID: One dose saline placebo administered ID
11075893|NCT01447407|FG003|Participant Flow|NDV-3 Vaccine ID|NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
11075894|NCT01447407|OG000|Outcome|NDV-3 Vaccine With Alum|NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
11075895|NCT01447407|OG001|Outcome|NDV-3 Vaccine Without Alum|NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
11075896|NCT01447407|OG002|Outcome|Placebo|Placebo administered ID: One dose saline placebo administered ID
11075897|NCT01447407|OG003|Outcome|NDV-3 Vaccine ID|NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
11075898|NCT01447407|EG000|Reported Event|NDV-3 Vaccine With Alum|NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
11075899|NCT01447407|EG001|Reported Event|NDV-3 Vaccine Without Alum|NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
11075900|NCT01447407|EG002|Reported Event|Placebo|Placebo administered ID: One dose saline placebo administered ID
11075901|NCT01447407|EG003|Reported Event|NDV-3 Vaccine ID|NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
11075902|NCT01447420|BG000|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
11075903|NCT01447420|BG001|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered with peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
11075904|NCT01447420|BG002|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
11075905|NCT01447420|BG003|Baseline|Total|Total of all reporting groups
11075906|NCT01447420|FG000|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
11075907|NCT01447420|FG001|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
11075908|NCT01447420|FG002|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
11075909|NCT01447420|OG000|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
11075910|NCT01447420|OG001|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
11075911|NCT01447420|OG002|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
11075912|NCT01447420|OG000|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a 180 mcg SC weekly, 48 weeks and Ribavirin 1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg, orally daily, 48 weeks
11075913|NCT01447420|EG000|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for < 75 kg and 1200 mg per day for >= 75 kg, orally daily, 48 weeks.
11075914|NCT01447433|BG000|Baseline|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
11075915|NCT01447433|BG001|Baseline|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
11075916|NCT01447433|BG002|Baseline|Total|Total of all reporting groups
11075917|NCT01447433|FG000|Participant Flow|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
11075918|NCT01447433|FG001|Participant Flow|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
11075919|NCT01447433|OG000|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
11075920|NCT01447433|OG001|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
11075921|NCT01447433|EG000|Reported Event|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
11075922|NCT01447433|EG001|Reported Event|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
11075923|NCT01447446|BG000|Baseline|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075924|NCT01447446|BG001|Baseline|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075925|NCT01447446|BG002|Baseline|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075926|NCT01447446|BG003|Baseline|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075927|NCT01447446|BG004|Baseline|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075928|NCT01447446|BG005|Baseline|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075929|NCT01447446|BG006|Baseline|Total|Total of all reporting groups
11075930|NCT01447446|FG000|Participant Flow|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075931|NCT01447446|FG001|Participant Flow|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11173604|NCT02016560|EG000|Reported Event|Exploratory Younger Cognitively Healthy Subjects|Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29
11349093|NCT04123665|FG000|Participant Flow|Experimental Test Stannous Fluoride Dentifrice|In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight [w/w] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
11349094|NCT04123665|FG001|Participant Flow|Control Sodium Monofluorophosphate Dentifrice|In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million [ppm] fluoride as sodium monofluorophosphate [SMFP] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
11349095|NCT04123665|OG000|Outcome|Experimental Test Stannous Fluoride Dentifrice|In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight [w/w] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
11349096|NCT04123665|OG001|Outcome|Control Sodium Monofluorophosphate Dentifrice|In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million [ppm] fluoride as sodium monofluorophosphate [SMFP] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
11349097|NCT04123665|EG000|Reported Event|Experimental Test Stannous Fluoride Dentifrice|In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight [w/w] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
11349098|NCT04123665|EG001|Reported Event|Control Sodium Monofluorophosphate Dentifrice|In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million [ppm] fluoride as sodium monofluorophosphate [SMFP] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
11349099|NCT04122534|BG000|Baseline|Treatment Group|"Treatment groups receives the intervention training.~Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma."
11349100|NCT04122534|FG000|Participant Flow|Treatment Group|"Treatment groups receives the intervention training.~Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma."
11349101|NCT04122534|OG000|Outcome|Treatment Group|"Treatment groups receives the intervention training.~Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma."
11349102|NCT04122534|EG000|Reported Event|Treatment Group|"Treatment groups receives the intervention training.~Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma."
11349103|NCT04121078|BG000|Baseline|Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg|TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2.
11349104|NCT04121078|BG001|Baseline|Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg|Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2.
11349105|NCT04121078|BG002|Baseline|Total|Total of all reporting groups
10887656|NCT00502216|BG001|Baseline|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
10887657|NCT00502216|BG002|Baseline|Total|Total of all reporting groups
11075932|NCT01447446|FG002|Participant Flow|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075933|NCT01447446|FG003|Participant Flow|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11349106|NCT04121078|FG000|Participant Flow|Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg|TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2.
11349107|NCT04121078|FG001|Participant Flow|Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg|Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2.
11349108|NCT04121078|OG000|Outcome|Treatment A: TAK-906 25 mg|TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
11349109|NCT04121078|OG001|Outcome|Treatment B: Rifampin 600 mg and TAK-906 25 mg|Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
11349110|NCT04121078|EG000|Reported Event|Treatment A: TAK-906 25 mg|TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
11349111|NCT04121078|EG001|Reported Event|Treatment B: Rifampin 600 mg and TAK-906 25 mg|Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
11349112|NCT04117607|BG000|Baseline|SAD1|1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
11349113|NCT04117607|BG001|Baseline|SAD2|10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
11075934|NCT01447446|FG004|Participant Flow|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075935|NCT01447446|FG005|Participant Flow|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075936|NCT01447446|OG000|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075937|NCT01447446|OG001|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075938|NCT01447446|OG002|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075939|NCT01447446|OG003|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075940|NCT01447446|OG004|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075941|NCT01447446|OG005|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075942|NCT01447446|OG000|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075943|NCT01447446|OG001|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075944|NCT01447446|OG002|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075945|NCT01447446|OG003|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075946|NCT01447446|OG000|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075947|NCT01447446|OG001|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075948|NCT01447446|EG000|Reported Event|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075949|NCT01447446|EG001|Reported Event|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075950|NCT01447446|EG002|Reported Event|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075951|NCT01447446|EG003|Reported Event|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075952|NCT01447446|EG004|Reported Event|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
10887658|NCT00502216|FG000|Participant Flow|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
11075953|NCT01447446|EG005|Reported Event|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
11075954|NCT01447511|BG000|Baseline|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075955|NCT01447511|BG001|Baseline|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
11075956|NCT01447511|BG002|Baseline|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075957|NCT01447511|BG003|Baseline|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075958|NCT01447511|BG004|Baseline|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075959|NCT01447511|BG005|Baseline|Total|Total of all reporting groups
11075960|NCT01447511|FG000|Participant Flow|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075961|NCT01447511|FG001|Participant Flow|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
11075962|NCT01447511|FG002|Participant Flow|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075963|NCT01447511|FG003|Participant Flow|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075964|NCT01447511|FG004|Participant Flow|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075965|NCT01447511|OG000|Outcome|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075966|NCT01447511|OG001|Outcome|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
11075967|NCT01447511|OG002|Outcome|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075968|NCT01447511|OG003|Outcome|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075969|NCT01447511|OG004|Outcome|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075970|NCT01447511|EG000|Reported Event|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075971|NCT01447511|EG001|Reported Event|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
11075972|NCT01447511|EG002|Reported Event|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075973|NCT01447511|EG003|Reported Event|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075974|NCT01447511|EG004|Reported Event|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
11075975|NCT01447576|BG000|Baseline|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
11075976|NCT01447576|FG000|Participant Flow|Brexpiprazole +ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
11075977|NCT01447576|OG000|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
11075978|NCT01447576|EG000|Reported Event|Brexpiprazole+ADT|Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT.
11075979|NCT01447706|BG000|Baseline|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
11075980|NCT01447706|BG001|Baseline|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
11075981|NCT01447706|BG002|Baseline|Total|Total of all reporting groups
11075982|NCT01447706|FG000|Participant Flow|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
11075983|NCT01447706|FG001|Participant Flow|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
11075984|NCT01447706|OG000|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
11075985|NCT01447706|OG001|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
11075986|NCT01447706|OG000|Outcome|HRG High: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
11075987|NCT01447706|OG001|Outcome|HRG High: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
11075988|NCT01447706|OG002|Outcome|HRG Low: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
11075989|NCT01447706|OG003|Outcome|HRG Low: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
11075990|NCT01447706|EG000|Reported Event|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
11075991|NCT01447706|EG001|Reported Event|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
11075992|NCT01447719|BG000|Baseline|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
11075993|NCT01447719|FG000|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
11075994|NCT01447719|OG000|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
11075995|NCT01447719|OG000|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
11075996|NCT01447719|OG000|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
11075997|NCT01447719|OG000|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
11075998|NCT01447719|OG000|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 year of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
11075999|NCT01447719|OG000|Outcome|Autopsy Within 1 Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
11076000|NCT01447719|EG000|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
11076001|NCT01447849|BG000|Baseline|Chronic Constipation(CC) Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation (CC) received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
11076002|NCT01447849|BG001|Baseline|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation (CC)received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
11076003|NCT01447849|BG002|Baseline|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
11076004|NCT01447849|BG003|Baseline|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
11076005|NCT01447849|BG004|Baseline|Total|Total of all reporting groups
11076006|NCT01447849|FG000|Participant Flow|Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation received 1 week of therapy with lubiprostone,then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
11076007|NCT01447849|FG001|Participant Flow|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
11076008|NCT01447849|FG002|Participant Flow|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
11076009|NCT01447849|FG003|Participant Flow|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
11076010|NCT01447849|OG000|Outcome|Lubiprostone 24 mcg BID|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
11076011|NCT01447849|OG001|Outcome|Placebo|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
11076012|NCT01447849|OG000|Outcome|Lubiprostone 24 mcg Bid|Both controls and patients with chronic constipation received lubiprostone 24 mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
11076013|NCT01447849|OG001|Outcome|Placebo|Both controls and patients with chronic constipation received lubiprostone 24mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
11076014|NCT01447849|EG000|Reported Event|Chronic Constipation Subjects on Lubiprostone Then Placebo|Subjects with chronic constipation who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
11076015|NCT01447849|EG001|Reported Event|Chronic Constipation Subjects on Placebo Then Lubiprostone|Subjects with chronic constipation who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
11076016|NCT01447849|EG002|Reported Event|Controls on Lubiprostone Then Placebo|Control group who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
11076017|NCT01447849|EG003|Reported Event|Controls on Placebo Then Lubiprostone|Control group who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
11076018|NCT01447888|BG000|Baseline|150% Oral Morphine Equivalent (OME)|"Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients~150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl."
11076019|NCT01447888|BG001|Baseline|Control|"Standard perioperative dosing, which does not currently account for patients' baseline opiate use.~Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist."
11076020|NCT01447888|BG002|Baseline|Total|Total of all reporting groups
11076021|NCT01447888|FG000|Participant Flow|150% Oral Morphine Equivalent (OME)|"Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients~150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl."
11076022|NCT01447888|FG001|Participant Flow|Control|"Standard perioperative dosing, which does not currently account for patients' baseline opiate use.~Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist."
11076023|NCT01447888|OG000|Outcome|150% Oral Morphine Equivalent (OME)|"Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients~150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl."
11076024|NCT01447888|OG001|Outcome|Control|"Standard perioperative dosing, which does not currently account for patients' baseline opiate use.~Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist."
11076025|NCT01447888|EG000|Reported Event|150% Oral Morphine Equivalent (OME)|"Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients~150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl."
11076026|NCT01447888|EG001|Reported Event|Control|"Standard perioperative dosing, which does not currently account for patients' baseline opiate use.~Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist."
11076027|NCT01447914|BG000|Baseline|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
11076028|NCT01447914|FG000|Participant Flow|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
11076029|NCT01447914|OG000|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
11076030|NCT01447914|EG000|Reported Event|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
11076031|NCT01447927|BG000|Baseline|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
11076032|NCT01447927|BG001|Baseline|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
11076033|NCT01447927|BG002|Baseline|Total|Total of all reporting groups
11076034|NCT01447927|FG000|Participant Flow|Metformin|Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD) on week 1, and twice daily (BID) on weeks 2-12 (every morning (QAM) every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
11076035|NCT01447927|FG001|Participant Flow|Placebo|Patients receive extended-release placebo orally (PO) once daily (QD) on week 1and BID on weeks 2-12 (every morning (QAM) and every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
11076036|NCT01447927|OG000|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
11076037|NCT01447927|OG001|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
11076038|NCT01447927|EG000|Reported Event|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
11076039|NCT01447927|EG001|Reported Event|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
11076040|NCT01448044|BG000|Baseline|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
11076041|NCT01448044|BG001|Baseline|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
11076042|NCT01448044|BG002|Baseline|Total|Total of all reporting groups
11076043|NCT01448044|FG000|Participant Flow|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
11076044|NCT01448044|FG001|Participant Flow|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
11173605|NCT02016560|EG001|Reported Event|Exploratory Older Cognitively Healthy Subjects|Male or female subjects ≥50 years of age with MMSE ≥29
11173606|NCT02016560|EG002|Reported Event|Exploratory MCI Subjects|Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24
11076045|NCT01448044|OG000|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
11076046|NCT01448044|OG001|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
11076047|NCT01448044|EG000|Reported Event|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
11076048|NCT01448044|EG001|Reported Event|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
11076049|NCT01448057|BG000|Baseline|Arm A|"Combination Product~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
11076050|NCT01448057|BG001|Baseline|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
11076051|NCT01448057|BG002|Baseline|Total|Total of all reporting groups
11076052|NCT01448057|FG000|Participant Flow|Combination Product|"Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
11076053|NCT01448057|FG001|Participant Flow|Paracetamol Tablets|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
11076054|NCT01448057|OG000|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
11076055|NCT01448057|OG001|Outcome|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
11076056|NCT01448057|EG000|Reported Event|Arm A|"Combination Product~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
11076057|NCT01448057|EG001|Reported Event|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
11076058|NCT01448213|BG000|Baseline|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
11076059|NCT01448213|BG001|Baseline|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
11076060|NCT01448213|BG002|Baseline|Total|Total of all reporting groups
11076061|NCT01448213|FG000|Participant Flow|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
11076062|NCT01448213|FG001|Participant Flow|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
11076063|NCT01448213|OG000|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
11076064|NCT01448213|OG001|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
11076065|NCT01448213|EG000|Reported Event|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
11076066|NCT01448213|EG001|Reported Event|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
11076067|NCT01448356|BG000|Baseline|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
11076068|NCT01448356|FG000|Participant Flow|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
11076069|NCT01448356|OG000|Outcome|Temperature and Humidity|Tear evaporation of overall surface
11076070|NCT01448356|OG000|Outcome|Temperature and Humidity|average of three measurements
11076071|NCT01448356|EG000|Reported Event|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
11076072|NCT01448421|BG000|Baseline|Keystone Heart Embolic Deflection Device|"Protected Transcatheter Aortic Valve Replacement~Keystone Heart Embolic Deflection Device: The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures."
11076073|NCT01448421|FG000|Participant Flow|Keystone Heart Embolic Deflection Device|"Protected Transcatheter Aortic Valve Replacement~Keystone Heart Embolic Deflection Device: The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures."
11076074|NCT01448421|OG000|Outcome|Keystone Heart Embolic Deflection Device|"Protected Transcatheter Aortic Valve Replacement~Keystone Heart Embolic Deflection Device: The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures."
11076075|NCT01448421|EG000|Reported Event|Keystone Heart Embolic Deflection Device|"Protected Transcatheter Aortic Valve Replacement~The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures."
11076076|NCT01448447|BG000|Baseline|Sole Method|"patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS~Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days"
11076077|NCT01448447|BG001|Baseline|Boost|"patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS~Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)"
11076078|NCT01448447|BG002|Baseline|Total|Total of all reporting groups
11076079|NCT01448447|FG000|Participant Flow|Sole Method|"patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS~Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days"
11076080|NCT01448447|FG001|Participant Flow|Boost|"patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS~Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)"
11076081|NCT01448447|OG000|Outcome|Sole Method|"patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS~Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days"
11076082|NCT01448447|OG001|Outcome|Boost|"patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS~Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)"
11076083|NCT01448447|EG000|Reported Event|Sole Method|"patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS~Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days"
11076084|NCT01448447|EG001|Reported Event|Boost|"patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS~Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)"
11349114|NCT04117607|BG002|Baseline|SAD Placebo|Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
11349115|NCT04117607|BG003|Baseline|Total|Total of all reporting groups
11076085|NCT01448486|BG000|Baseline|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
11076086|NCT01448486|BG001|Baseline|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
11076087|NCT01448486|BG002|Baseline|Total|Total of all reporting groups
11076088|NCT01448486|FG000|Participant Flow|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
11076089|NCT01448486|FG001|Participant Flow|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
11076090|NCT01448486|OG000|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
11076091|NCT01448486|OG001|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
11076092|NCT01448486|EG000|Reported Event|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
11076093|NCT01448486|EG001|Reported Event|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
11076094|NCT01448525|BG000|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
11076095|NCT01448525|BG001|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
11076096|NCT01448525|BG002|Baseline|Total|Total of all reporting groups
11076097|NCT01448525|FG000|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
11076098|NCT01448525|FG001|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
11076099|NCT01448525|OG000|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
11076100|NCT01448525|OG001|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
11076101|NCT01448525|EG000|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
11076102|NCT01448525|EG001|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
11076103|NCT01448616|BG000|Baseline|Oral TDF + Vaginal Placebo Gel|Participants randomized to receive 300mg Tenofovir Disaproxil Fumarate (TDF) 1 tab daily + the universal placebo vaginal gel (4ml) to be used daily.
11076104|NCT01448616|BG001|Baseline|Oral Placebo + Vaginal TFV Gel|Participants randomized to receive matching oral placebo tab once daily + tenofovir (TFV) 1% vaginal gel (40mg in 4ml) to be used daily
11076105|NCT01448616|BG002|Baseline|Oral Placebo + Vaginal Placebo Gel|Participants received matching oral tab and placebo gel both to be used daily
11076106|NCT01448616|BG003|Baseline|Total|Total of all reporting groups
11076107|NCT01448616|FG000|Participant Flow|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
11076108|NCT01448616|FG001|Participant Flow|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
11076109|NCT01448616|FG002|Participant Flow|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
11076110|NCT01448616|FG003|Participant Flow|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
10887659|NCT00502216|FG001|Participant Flow|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
11076111|NCT01448616|OG000|Outcome|Oral TDF + Vaginal Placebo Gel|"tenofovir disoproxil fumarate (TDF): Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.~placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects - negative or positive - on study endpoints."
11076112|NCT01448616|OG001|Outcome|Oral Placebo + Vaginal TFV Gel|"Tenofovir: Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator 40mg/4ml) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals."
11173607|NCT02016560|EG003|Reported Event|Exploratory AD Subjects|Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE >10
11173608|NCT02016560|EG004|Reported Event|Confirmatory Subjects MCI|Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
11076113|NCT01448616|OG002|Outcome|Oral Placebo + Vaginal Placebo|"placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.~placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects - negative or positive - on study endpoints."
11076114|NCT01448616|OG000|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
11076115|NCT01448616|OG001|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
11076116|NCT01448616|OG002|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
11076117|NCT01448616|OG001|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg/4ml of TFV gel both to be used daily
11076118|NCT01448616|EG000|Reported Event|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
11076119|NCT01448616|EG001|Reported Event|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
11076120|NCT01448616|EG002|Reported Event|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
11076121|NCT01448616|EG003|Reported Event|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
11076122|NCT01448707|BG000|Baseline|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
11076123|NCT01448707|BG001|Baseline|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
11076124|NCT01448707|BG002|Baseline|Total|Total of all reporting groups
11076125|NCT01448707|FG000|Participant Flow|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
11076126|NCT01448707|FG001|Participant Flow|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
11076127|NCT01448707|OG000|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
11076128|NCT01448707|OG001|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
11076129|NCT01448707|EG000|Reported Event|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
11076130|NCT01448707|EG001|Reported Event|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
11076131|NCT01448824|BG000|Baseline|Part 1 (Cohort A) Sequence 1|Participants received 100 milligrams (mg) LY2484595 (tablets, oral administration) QD on Days 1 through 14. Then, received 1800 mg LY2484595 QD on Days 1 through 14 period 2.
11076132|NCT01448824|BG001|Baseline|Part 1 (Cohort A) Sequence 2|Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 and 1800 mg LY2484595 on Days 1 through 14 of Period 2).
11076133|NCT01448824|BG002|Baseline|Part 1 (Cohort A) Sequence 3|Participants received 100 mg LY2484595 (tablets, oral administration) once daily (QD) on Days 1 through 14. Then, received placebo QD on Days 1 through 14 period 2.
11076134|NCT01448824|BG003|Baseline|Part 1 (Cohort B Through D) Placebo|Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14.
11076135|NCT01448824|BG004|Baseline|Part 1 (Cohort B)|Participants received 300 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14.
11076136|NCT01448824|BG005|Baseline|Part 1 (Cohort C)|Participants received 600 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14.
11076137|NCT01448824|BG006|Baseline|Part 1 (Cohort D)|Participants received 1200 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14.
11076138|NCT01448824|BG007|Baseline|Part 2 (Cohort E)|Participants received 100 mg LY2484595 (tablet, oral administration) as a single dose on Day 1 of Period 1. After a washout period lasting ≥14 days, participants received 400 mg ketoconazole (tablet, oral administration, QD) on Days 1 through 4 of Period 2, 400 mg ketoconazole (tablet, oral administration) and 100 mg LY2484595 (tablet, oral administration) on Day 5 of Period 2, and 400 mg ketoconazole (tablet, oral administration, QD) on Days 6 through 14 of Period 2.
11076139|NCT01448824|BG008|Baseline|Total|Total of all reporting groups
11076140|NCT01448824|FG000|Participant Flow|Part 1 Cohort A Sequence 1|"Period 1:~LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1.~Washout period lasting ≥14 days.~Period 2:~LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2."
11076141|NCT01448824|FG001|Participant Flow|Part 1 Cohort A Sequence 2|"Period 1:~Placebo: dose-matched tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1.~Washout period lasting ≥ 14 days~Period 2:~LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2."
10887660|NCT00502216|OG000|Outcome|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
11076142|NCT01448824|FG002|Participant Flow|Part 1 Cohort A Sequence 3|"Period 1:~LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1~Washout period lasting ≥14 days~Period 2:~Placebo: tablets, oral administration, QD on Days 1 through 14 of Period 2"
11076143|NCT01448824|FG003|Participant Flow|Part 1 (Cohorts B Through D): Placebo|Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14.
11076144|NCT01448824|FG004|Participant Flow|Part 1 Cohort B|LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
11076145|NCT01448824|FG005|Participant Flow|Part 1 Cohort C|LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
11076146|NCT01448824|FG006|Participant Flow|Part 1 Cohort D|LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
11076147|NCT01448824|FG007|Participant Flow|Part 2 Cohort E|"Period 1:~LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1.~Washout period lasting ≥ 14 days~Period 2:~Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2.~LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2."
11076148|NCT01448824|OG000|Outcome|Part 1 (Cohorts A Through D): Placebo|Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
11076149|NCT01448824|OG001|Outcome|Part 1, Period 1 (Cohort A): 100 mg LY2484595|LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
11076150|NCT01448824|OG002|Outcome|Part 1 (Cohort B): 300 mg LY2484595|LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076151|NCT01448824|OG003|Outcome|Part 1 (Cohort C): 600 mg LY2484595|LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076152|NCT01448824|OG004|Outcome|Part 1 (Cohort D): 1200 mg LY2484595|LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076153|NCT01448824|OG005|Outcome|Part 1, Period 2 (Cohort A): 1800 mg LY2484595|LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
11076154|NCT01448824|OG000|Outcome|Part 2, Period 1: 100 mg LY2484595|"Period 1:~LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1~Washout period lasting ≥ 14 days~Period 2:~Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2~LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2"
11076155|NCT01448824|OG001|Outcome|Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole|"Period 1:~LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1~Washout period lasting ≥ 14 days~Period 2:~Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2~LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2"
11076156|NCT01448824|OG000|Outcome|Part 2, Period 1: 100 mg LY2484595|"Period 1:~LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1~Washout period lasting ≥ 14 days~Period 2:~Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2.~LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2"
11076157|NCT01448824|OG001|Outcome|Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole|"Period 1:~LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1~Washout period lasting ≥ 14 days~Period 2:~Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2.~LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2"
11076158|NCT01448824|OG000|Outcome|Part 1, Period 1 (Cohorts A Through D): Placebo|Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts)
11076159|NCT01448824|OG000|Outcome|Part 1, Period 1 (Cohort A): 100 mg LY2484595|LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
11076160|NCT01448824|OG001|Outcome|Part 1 (Cohort B): 300 mg LY2484595|LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076161|NCT01448824|OG002|Outcome|Part 1 (Cohort C): 600 mg LY2484595|LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076162|NCT01448824|OG003|Outcome|Part 1 (Cohort D): 1200 mg LY2484595|LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076163|NCT01448824|OG004|Outcome|Part 1, Period 2 (Cohort A): 1800 mg LY2484595|LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
11076164|NCT01448824|OG004|Outcome|Part 1, Period 2 (Cohort A): 1800 mg LY2484595|LY284595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
11076165|NCT01448824|EG000|Reported Event|Part 1 (Cohorts A Through D)|Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
11076166|NCT01448824|EG001|Reported Event|Part 1, Period 1 (Cohort A)|LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
11076167|NCT01448824|EG002|Reported Event|Part 1, Period 2 (Cohort A)|LY284595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
11076168|NCT01448824|EG003|Reported Event|Part 1 (Cohort B): 300 mg LY2484595|LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076169|NCT01448824|EG004|Reported Event|Part 1 (Cohort C): 600 mg LY2484595|LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076170|NCT01448824|EG005|Reported Event|Part 1 (Cohort D): 1200 mg LY2484595|LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
11076171|NCT01448824|EG006|Reported Event|Part 2, Period 1: 100 mg LY2484595|"Period 1:~LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1~Washout period lasting ≥ 14 days~Period 2:~Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2~LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2"
11173609|NCT02016560|EG005|Reported Event|Confirmatory Subjects AD|Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
11227385|NCT02382913|FG003|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227386|NCT02382913|FG004|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227387|NCT02382913|FG005|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11076172|NCT01448824|EG007|Reported Event|Part 2, Period 2: 400 mg Ketoconazole|"Period 1:~LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1~Washout period lasting ≥ 14 days~Period 2:~Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2~LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2"
11076173|NCT01448824|EG008|Reported Event|Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole|"Period 1:~LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1~Washout period lasting ≥ 14 days~Period 2:~Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2~LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2"
11076174|NCT01448850|BG000|Baseline|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
11076175|NCT01448850|BG001|Baseline|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
11076176|NCT01448850|BG002|Baseline|Total|Total of all reporting groups
11076177|NCT01448850|FG000|Participant Flow|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
11076178|NCT01448850|FG001|Participant Flow|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
11076179|NCT01448850|OG000|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
11076180|NCT01448850|OG001|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
11076181|NCT01448850|OG000|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
11076182|NCT01448850|EG000|Reported Event|PLACEBO|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
11227388|NCT02382913|FG006|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227389|NCT02382913|FG007|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227390|NCT02382913|FG008|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227391|NCT02382913|FG009|Participant Flow|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227392|NCT02382913|OG000|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227393|NCT02382913|OG001|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227394|NCT02382913|OG002|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11076183|NCT01448850|EG001|Reported Event|MEDI8968 300 mg|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5.
11076184|NCT01449006|BG000|Baseline|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
11076185|NCT01449006|BG001|Baseline|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
11076186|NCT01449006|BG002|Baseline|Total|Total of all reporting groups
11076187|NCT01449006|FG000|Participant Flow|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
11076188|NCT01449006|FG001|Participant Flow|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
11076189|NCT01449006|OG000|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
11076190|NCT01449006|OG001|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
11076191|NCT01449006|EG000|Reported Event|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
11076192|NCT01449006|EG001|Reported Event|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
11076193|NCT01449240|BG000|Baseline|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
11076194|NCT01449240|FG000|Participant Flow|No Investigational Treatment or Control Group|This was an observational study for the collection and study of cerebrospinal fluid (CSF) in patients with Hunter syndrome. No investigational treatment was given.
11076195|NCT01449240|OG000|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
11076196|NCT01449240|EG000|Reported Event|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given. Safety analyses were performed in the Safety Population, which was defined as all patients who had undergone a procedure for CSF sample collection. This included a patient who underwent unsuccessful CSF sample collection; no CSF or urine GAG data were available for this adult patient.
11076197|NCT01449266|BG000|Baseline|Dotarem®-Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
11076198|NCT01449266|FG000|Participant Flow|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
11076199|NCT01449266|OG000|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
11076200|NCT01449266|EG000|Reported Event|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem: Dotarem® was administered at a single dose of 0.1 mmoL/kg (0.2 mL/kg)."
11076201|NCT01449279|BG000|Baseline|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
11349116|NCT04117607|FG000|Participant Flow|SAD1|"1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11076202|NCT01449279|FG000|Participant Flow|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
11076203|NCT01449279|OG000|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
11076204|NCT01449279|EG000|Reported Event|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
11076205|NCT01449305|BG000|Baseline|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
11076206|NCT01449305|FG000|Participant Flow|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
11076207|NCT01449305|OG000|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
11076208|NCT01449305|EG000|Reported Event|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
11076209|NCT01449370|BG000|Baseline|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076210|NCT01449370|BG001|Baseline|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076211|NCT01449370|BG002|Baseline|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076212|NCT01449370|BG003|Baseline|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076213|NCT01449370|BG004|Baseline|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076214|NCT01449370|BG005|Baseline|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076215|NCT01449370|BG006|Baseline|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076216|NCT01449370|BG007|Baseline|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076217|NCT01449370|BG008|Baseline|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076218|NCT01449370|BG009|Baseline|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076219|NCT01449370|BG010|Baseline|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11349117|NCT04117607|FG001|Participant Flow|SAD2|"10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11076220|NCT01449370|BG011|Baseline|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076221|NCT01449370|BG012|Baseline|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076222|NCT01449370|BG013|Baseline|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076223|NCT01449370|BG014|Baseline|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076224|NCT01449370|BG015|Baseline|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076225|NCT01449370|BG016|Baseline|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076226|NCT01449370|BG017|Baseline|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076227|NCT01449370|BG018|Baseline|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11349118|NCT04117607|FG002|Participant Flow|SAD3|"30 mg (1 injection of 0.3 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11076228|NCT01449370|BG019|Baseline|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076229|NCT01449370|BG020|Baseline|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076230|NCT01449370|BG021|Baseline|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076231|NCT01449370|BG022|Baseline|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076232|NCT01449370|BG023|Baseline|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076233|NCT01449370|BG024|Baseline|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076234|NCT01449370|BG025|Baseline|Total|Total of all reporting groups
11076235|NCT01449370|FG000|Participant Flow|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076236|NCT01449370|FG001|Participant Flow|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076237|NCT01449370|FG002|Participant Flow|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076238|NCT01449370|FG003|Participant Flow|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11349119|NCT04117607|FG003|Participant Flow|SAD4|"60 mg (1 injection of 0.6 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11076239|NCT01449370|FG004|Participant Flow|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076240|NCT01449370|FG005|Participant Flow|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076241|NCT01449370|FG006|Participant Flow|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076242|NCT01449370|FG007|Participant Flow|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076243|NCT01449370|FG008|Participant Flow|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076244|NCT01449370|FG009|Participant Flow|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076245|NCT01449370|FG010|Participant Flow|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076246|NCT01449370|FG011|Participant Flow|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076247|NCT01449370|FG012|Participant Flow|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076248|NCT01449370|FG013|Participant Flow|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076249|NCT01449370|FG014|Participant Flow|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076250|NCT01449370|FG015|Participant Flow|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076251|NCT01449370|FG016|Participant Flow|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076252|NCT01449370|FG017|Participant Flow|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076253|NCT01449370|FG018|Participant Flow|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076254|NCT01449370|FG019|Participant Flow|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076255|NCT01449370|FG020|Participant Flow|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076256|NCT01449370|FG021|Participant Flow|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076257|NCT01449370|FG022|Participant Flow|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076258|NCT01449370|FG023|Participant Flow|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076259|NCT01449370|FG024|Participant Flow|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076260|NCT01449370|OG000|Outcome|Process A: Total QD TAK-117 100-300 mg|TAK-117 100-300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076261|NCT01449370|OG001|Outcome|Process A: Total MWF QW 200-1200 mg|TAK-117 200-1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076262|NCT01449370|OG002|Outcome|Process A: Total MTW QW 200-900 mg|TAK-117 200-900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076263|NCT01449370|OG003|Outcome|Process B: Total FM MWF QW TAK-117 600-1200 mg|TAK-117 600-1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076264|NCT01449370|OG004|Outcome|Process B: Total FM MTW QW 600-1500 mg|TAK-117 600-1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076265|NCT01449370|OG005|Outcome|Process B: Total FM BID MWF QW 300-600 mg|TAK-117 300-600 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076266|NCT01449370|OG000|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076267|NCT01449370|OG001|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076268|NCT01449370|OG002|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076269|NCT01449370|OG003|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11227395|NCT02382913|OG003|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11076270|NCT01449370|OG004|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076271|NCT01449370|OG005|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076272|NCT01449370|OG006|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076273|NCT01449370|OG007|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076274|NCT01449370|OG008|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076275|NCT01449370|OG009|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076276|NCT01449370|OG010|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076277|NCT01449370|OG011|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076278|NCT01449370|OG012|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076279|NCT01449370|OG013|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076280|NCT01449370|OG014|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076281|NCT01449370|OG015|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076282|NCT01449370|OG016|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11173610|NCT02016612|BG000|Baseline|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11076283|NCT01449370|OG017|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076284|NCT01449370|OG018|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076285|NCT01449370|OG019|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076286|NCT01449370|OG020|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076287|NCT01449370|OG021|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076288|NCT01449370|OG022|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076289|NCT01449370|OG023|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076290|NCT01449370|OG024|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076291|NCT01449370|OG000|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
11076292|NCT01449370|OG001|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
11076293|NCT01449370|OG002|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
11076294|NCT01449370|OG003|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
11076295|NCT01449370|OG004|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
11076296|NCT01449370|OG005|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
11076297|NCT01449370|OG006|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
11076298|NCT01449370|OG007|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
11076299|NCT01449370|OG008|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
11076300|NCT01449370|OG009|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
11076301|NCT01449370|OG010|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
11076302|NCT01449370|OG011|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
11076303|NCT01449370|OG012|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
11076304|NCT01449370|OG013|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
11076305|NCT01449370|OG014|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
11076306|NCT01449370|EG000|Reported Event|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076307|NCT01449370|EG001|Reported Event|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076308|NCT01449370|EG002|Reported Event|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076309|NCT01449370|EG003|Reported Event|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
11076310|NCT01449370|EG004|Reported Event|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076311|NCT01449370|EG005|Reported Event|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076312|NCT01449370|EG006|Reported Event|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076313|NCT01449370|EG007|Reported Event|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076314|NCT01449370|EG008|Reported Event|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076315|NCT01449370|EG009|Reported Event|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076316|NCT01449370|EG010|Reported Event|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076317|NCT01449370|EG011|Reported Event|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076318|NCT01449370|EG012|Reported Event|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076319|NCT01449370|EG013|Reported Event|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
11076320|NCT01449370|EG014|Reported Event|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076321|NCT01449370|EG015|Reported Event|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076322|NCT01449370|EG016|Reported Event|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076323|NCT01449370|EG017|Reported Event|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076324|NCT01449370|EG018|Reported Event|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076325|NCT01449370|EG019|Reported Event|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076326|NCT01449370|EG020|Reported Event|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076327|NCT01449370|EG021|Reported Event|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076328|NCT01449370|EG022|Reported Event|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076329|NCT01449370|EG023|Reported Event|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076330|NCT01449370|EG024|Reported Event|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
11076331|NCT01449461|BG000|Baseline|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
11076332|NCT01449461|BG001|Baseline|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
11076333|NCT01449461|BG002|Baseline|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
11076334|NCT01449461|BG003|Baseline|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
11076335|NCT01449461|BG004|Baseline|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
11076336|NCT01449461|BG005|Baseline|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
11076337|NCT01449461|BG006|Baseline|Total|Total of all reporting groups
11076338|NCT01449461|FG000|Participant Flow|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
11076339|NCT01449461|FG001|Participant Flow|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
11076340|NCT01449461|FG002|Participant Flow|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
11076341|NCT01449461|FG003|Participant Flow|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
11076342|NCT01449461|FG004|Participant Flow|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
11076343|NCT01449461|FG005|Participant Flow|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
11076344|NCT01449461|OG000|Outcome|Brigatinib|All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
11076345|NCT01449461|OG000|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
11076346|NCT01449461|OG001|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
11076347|NCT01449461|OG002|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
11076348|NCT01449461|OG003|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
11076349|NCT01449461|OG004|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
11076350|NCT01449461|OG005|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
11076351|NCT01449461|OG000|Outcome|Brigatinib|All participants received brigatinib tablets, orally, once daily (QD) starting at 30 mg in each cycle of 28 days.
11076352|NCT01449461|OG000|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
11076353|NCT01449461|OG001|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
11076354|NCT01449461|OG002|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
11076355|NCT01449461|OG003|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
11076356|NCT01449461|OG004|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
11076357|NCT01449461|OG005|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
11076358|NCT01449461|OG006|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
11076359|NCT01449461|EG000|Reported Event|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
11076360|NCT01449461|EG001|Reported Event|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
11076361|NCT01449461|EG002|Reported Event|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
11076362|NCT01449461|EG003|Reported Event|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
11076363|NCT01449461|EG004|Reported Event|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
11076364|NCT01449461|EG005|Reported Event|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
11076365|NCT01449513|BG000|Baseline|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
11076366|NCT01449513|BG001|Baseline|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
11076367|NCT01449513|BG002|Baseline|Total|Total of all reporting groups
11076368|NCT01449513|FG000|Participant Flow|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
11076369|NCT01449513|FG001|Participant Flow|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
11076370|NCT01449513|OG000|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
11076371|NCT01449513|OG001|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
11357468|NCT03757234|EG000|Reported Event|Omadacycline 200 iv/200 iv|On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
11076372|NCT01449513|EG000|Reported Event|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
11076373|NCT01449513|EG001|Reported Event|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
11076374|NCT01449526|BG000|Baseline|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
11076375|NCT01449526|BG001|Baseline|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
11076376|NCT01449526|BG002|Baseline|Total|Total of all reporting groups
11076377|NCT01449526|FG000|Participant Flow|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
11076378|NCT01449526|FG001|Participant Flow|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
11076379|NCT01449526|OG000|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
11076380|NCT01449526|OG001|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
11076381|NCT01449526|EG000|Reported Event|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
11076382|NCT01449526|EG001|Reported Event|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
11076383|NCT01449539|BG000|Baseline|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres for 90 minutes at pressure. Treatment lasts about 2 hours as time is allowed for gradual pressurization and depressurization. Treated for two weeks a total of 10 HBOT treatments.
11076384|NCT01449539|FG000|Participant Flow|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
11076385|NCT01449539|OG000|Outcome|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres (the equivalent of being under 33 feet of sea water) for 90 minutes. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each participant will be treated for two weeks for a total of 10 HBOT treatments.
11076386|NCT01449539|EG000|Reported Event|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
11076387|NCT01449630|BG000|Baseline|Cohort I Sequence 1|"Participants received 5 mg LY3031207, Placebo and 400 mg Celecoxib as per the below dosing schedule.~Period 1: 5 mg LY3031207 , Period 2: Placebo, and Period 3: 400 mg Celecoxib"
11076388|NCT01449630|BG001|Baseline|Cohort I Sequence 2|"Participants received 5 mg LY3031207, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.~Period 1: 5 mg LY3031207, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib"
11076389|NCT01449630|BG002|Baseline|Cohort I Sequence 3|"Participants received Placebo, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.~Period 1: Placebo, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib"
11076390|NCT01449630|BG003|Baseline|Cohort II Sequence 1|"Participants received 25 mg LY3031207 and Placebo as per the below dosing schedule.~Period 1: 25 mg LY3031207, Period 2: Placebo and Period 3: Placebo"
11076391|NCT01449630|BG004|Baseline|Cohort II Sequence 2|"Participants received 25 mg LY3031207, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.~Period 1: 25 mg LY3031207, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)"
11076392|NCT01449630|BG005|Baseline|Cohort II Sequence 3|"Participants received Placebo, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.~Period 1: Placebo, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)"
11076393|NCT01449630|BG006|Baseline|Cohort III Sequence 1|"Participants received LY3031207 75 mg, Placebo and celecoxib as per the below dosing schedule.~Period 1: LY3031207 75 mg, Period 2: Placebo and Period 3: Celecoxib 400 mg"
11076394|NCT01449630|BG007|Baseline|Cohort III Sequence 2|"Participants received LY3031207 75 mg, LY3031207 900 mg and celecoxib as per the below dosing schedule.~Period 1: LY3031207 75 mg, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg"
11076395|NCT01449630|BG008|Baseline|Cohort III Sequence 3|"Participants received Placebo, LY3031207 900 mg and celecoxib as per the below dosing schedule.~Period 1: Placebo, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg"
11076396|NCT01449630|BG009|Baseline|Total|Total of all reporting groups
11076397|NCT01449630|FG000|Participant Flow|Cohort I Sequence 1|"Participants received 5 mg LY3031207, Placebo and 400 mg Celecoxib as per the below dosing schedule.~Period 1: 5 mg LY3031207 , Period 2: Placebo, and Period 3: 400 mg Celecoxib"
11076398|NCT01449630|FG001|Participant Flow|Cohort I Sequence 2|"Participants received 5 mg LY3031207, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.~Period 1: 5 mg LY3031207, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib"
11076399|NCT01449630|FG002|Participant Flow|Cohort I Sequence 3|"Participants received Placebo, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.~Period 1: Placebo, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib"
11076400|NCT01449630|FG003|Participant Flow|Cohort II Sequence 1|"Participants received 25 mg LY3031207 and Placebo as per the below dosing schedule.~Period 1: 25 mg LY3031207, Period 2: Placebo and Period 3: Placebo"
11076401|NCT01449630|FG004|Participant Flow|Cohort II Sequence 2|"Participants received 25 mg LY3031207, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.~Period 1: 25 mg LY3031207, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)"
11076402|NCT01449630|FG005|Participant Flow|Cohort II Sequence 3|"Participants received Placebo, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.~Period 1: Placebo, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)"
11076403|NCT01449630|FG006|Participant Flow|Cohort III Sequence 1|"Participants received LY3031207 75 mg, Placebo and celecoxib as per the below dosing schedule.~Period 1: LY3031207 75 mg, Period 2: Placebo and Period 3: Celecoxib 400 mg"
11076404|NCT01449630|FG007|Participant Flow|Cohort III Sequence 2|"Participants received LY3031207 75 mg, LY3031207 900 mg and celecoxib as per the below dosing schedule.~Period 1: LY3031207 75 mg, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg"
11076405|NCT01449630|FG008|Participant Flow|Cohort III Sequence 3|"Participants received Placebo, LY3031207 900 mg and celecoxib as per the below dosing schedule.~Period 1: Placebo, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg"
11076406|NCT01449630|OG000|Outcome|5 mg LY3031207|5 milligrams (mg) LY3031207 administered orally as capsules as a single dose.
11076407|NCT01449630|OG001|Outcome|25 mg LY3031207|25 mg LY3031207 administered orally as capsules as a single dose.
11076408|NCT01449630|OG002|Outcome|75 mg LY3031207|75 mg LY3031207 administered orally as capsules as a single dose.
11076409|NCT01449630|OG003|Outcome|225 mg LY3031207|225 mg LY3031207 administered orally as capsules as a single dose.
11076410|NCT01449630|OG004|Outcome|450 mg LY3031207 Fed|450 mg LY3031207 administered orally as capsules as a single dose.
11076411|NCT01449630|OG005|Outcome|450 mg LY3031207 Fasted|450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted.
11076412|NCT01449630|OG006|Outcome|900 mg LY3031207|900 mg LY3031207 administered orally as capsules as a single dose.
11076413|NCT01449630|OG007|Outcome|Placebo|Matched placebo capsules administered orally.
11076414|NCT01449630|OG008|Outcome|400 mg Celecoxib|400 mg Celecoxib administered orally as capsules.
11076415|NCT01449630|OG000|Outcome|5 mg LY3031207|5 mg LY3031207 administered orally as capsules as a single dose.
11076416|NCT01449630|OG004|Outcome|450 mg LY3031207 Fed|450 of LY3031207 administered orally as capsules as a single dose.
11076417|NCT01449630|EG000|Reported Event|5 mg LY3031207|5 mg LY3031207 administered orally as capsules as a single dose.
11076418|NCT01449630|EG001|Reported Event|25 mg LY3031207|25 mg LY3031207 administered orally as capsules as a single dose.
11076419|NCT01449630|EG002|Reported Event|75 mg LY3031207|75 mg LY3031207 administered orally as capsules as a single dose.
11076420|NCT01449630|EG003|Reported Event|225 mg LY3031207|225 mg LY3031207 administered orally as capsules as a single dose.
11076421|NCT01449630|EG004|Reported Event|450 mg LY3031207 Fed|450 mg LY3031207 administered orally as capsules as a single dose.
11076422|NCT01449630|EG005|Reported Event|450 mg LY3031207 Fasted|450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted before receiving drug.
11076423|NCT01449630|EG006|Reported Event|900 mg LY3031207|900 mg LY3031207 administered orally as capsules as a single dose.
11076424|NCT01449630|EG007|Reported Event|Placebo|Matched placebo capsules administered orally.
11076425|NCT01449630|EG008|Reported Event|400 mg Celecoxib|400 mg Celecoxib administered orally as capsules.
11076426|NCT01449682|BG000|Baseline|Ozurdex PRN|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks~Other Name: Ozurdex PRN"
11076427|NCT01449682|BG001|Baseline|Ozurdex q16 Weeks|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks~Other Name: Ozurdex PRN"
11076428|NCT01449682|BG002|Baseline|Total|Total of all reporting groups
11076429|NCT01449682|FG000|Participant Flow|Active Comparator: Ozurdex PRN|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks~Other Name: Ozurdex PRN"
11076430|NCT01449682|FG001|Participant Flow|Active Comparator: Ozurdex q16 Weeks|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks~Other Name: Ozurdex q16 weeks"
11076431|NCT01449682|OG000|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
11076432|NCT01449682|OG001|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
11076433|NCT01449682|EG000|Reported Event|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
11076434|NCT01449682|EG001|Reported Event|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
11076435|NCT01449708|BG000|Baseline|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.~patients in both groups receive antiemetic prophylaxis~postop management in both groups is similar in both groups"
11076436|NCT01449708|BG001|Baseline|TIVA|"patients in both groups receive antiemetic prophylaxis~patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively~postop management in both groups is similar in both groups"
11076437|NCT01449708|BG002|Baseline|Total|Total of all reporting groups
11076438|NCT01449708|FG000|Participant Flow|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)~postop management in both groups is similar in both groups"
11076439|NCT01449708|FG001|Participant Flow|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis~- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
11076440|NCT01449708|OG000|Outcome|Classic / Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
11076441|NCT01449708|OG001|Outcome|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
11076442|NCT01449708|OG000|Outcome|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)~postop management in both groups is similar in both groups"
11076443|NCT01449708|OG001|Outcome|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis~- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
11076444|NCT01449708|OG000|Outcome|All Study Participants|measure included all119 patients depending on surgical procedure
11076445|NCT01449708|EG000|Reported Event|Classic/Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
11076446|NCT01449708|EG001|Reported Event|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
11076447|NCT01449721|BG000|Baseline|Control|Standard medical care by the primary treatment team.
11076448|NCT01449721|BG001|Baseline|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
11076449|NCT01449721|BG002|Baseline|Total|Total of all reporting groups
11076450|NCT01449721|FG000|Participant Flow|Control|Standard medical care by the primary treatment team.
11076451|NCT01449721|FG001|Participant Flow|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
11076452|NCT01449721|OG000|Outcome|Control|Standard medical care by the primary treatment team.
11076453|NCT01449721|OG001|Outcome|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
11076454|NCT01449721|EG000|Reported Event|Control|Standard medical care by the primary treatment team.
11076455|NCT01449721|EG001|Reported Event|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
11076456|NCT01449734|BG000|Baseline|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
11076457|NCT01449734|FG000|Participant Flow|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
11076458|NCT01449734|OG000|Outcome|Family Satisfaction|All 215 surveyed relatives are contained in this group, since the study was observational without intervention.
11076459|NCT01449734|EG000|Reported Event|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
11076460|NCT01449747|BG000|Baseline|Non-responder|Sitagliptin non-response patients
11076461|NCT01449747|BG001|Baseline|Responder|Sitagliptin response patients
11076462|NCT01449747|BG002|Baseline|Total|Total of all reporting groups
11076463|NCT01449747|FG000|Participant Flow|Non-responder|Sitagliptin non-response patients
11076464|NCT01449747|FG001|Participant Flow|Responder|Sitagliptin response patients
11076465|NCT01449747|OG000|Outcome|Non-responder|Sitagliptin non-response patients
11076466|NCT01449747|OG001|Outcome|Responder|Sitagliptin response patients
11076467|NCT01449747|EG000|Reported Event|Non-responder|Sitagliptin non-response patients
11076468|NCT01449747|EG001|Reported Event|Responder|Sitagliptin response patients
11076469|NCT01449812|BG000|Baseline|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076470|NCT01449812|BG001|Baseline|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076471|NCT01449812|BG002|Baseline|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076472|NCT01449812|BG003|Baseline|Total|Total of all reporting groups
11076473|NCT01449812|FG000|Participant Flow|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076474|NCT01449812|FG001|Participant Flow|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076475|NCT01449812|FG002|Participant Flow|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076476|NCT01449812|OG000|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076477|NCT01449812|OG001|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076478|NCT01449812|OG002|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076479|NCT01449812|EG000|Reported Event|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076480|NCT01449812|EG001|Reported Event|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076481|NCT01449812|EG002|Reported Event|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
11076482|NCT01449864|BG000|Baseline|Proton RT|"Subjects receive proton radiation~Proton therapy: The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues."
11076483|NCT01449864|FG000|Participant Flow|Proton RT|"Subjects receive proton radiation~Proton therapy: The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues."
11076484|NCT01449864|OG000|Outcome|Proton RT|"Subjects receive proton radiation~Proton therapy: The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues."
11076485|NCT01449864|EG000|Reported Event|Proton RT|"Subjects receive proton radiation~Proton therapy: The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues."
11076486|NCT01449929|BG000|Baseline|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
11076487|NCT01449929|BG001|Baseline|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
11076488|NCT01449929|BG002|Baseline|Total|Total of all reporting groups
11076489|NCT01449929|FG000|Participant Flow|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
11076490|NCT01449929|FG001|Participant Flow|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
11076491|NCT01449929|FG002|Participant Flow|Extension DTG 50 mg|DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase
11076492|NCT01449929|OG000|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
11076493|NCT01449929|OG001|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
11076494|NCT01449929|OG000|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
11076495|NCT01449929|OG001|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
11076496|NCT01449929|OG001|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
11076497|NCT01449929|EG000|Reported Event|DTG 50mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
11076498|NCT01449929|EG001|Reported Event|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
11076499|NCT01449929|EG002|Reported Event|Extension DTG 50 mg|DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase
11076500|NCT01449955|BG000|Baseline|Rapamycin|15mg Rapamycin administered once in pill form
11076501|NCT01449955|BG001|Baseline|Placebo|15mg Placebo administered once in pill form
11076502|NCT01449955|BG002|Baseline|Total|Total of all reporting groups
11076503|NCT01449955|FG000|Participant Flow|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
11076504|NCT01449955|FG001|Participant Flow|Placebo|15mg Placebo administered once in pill form
11076505|NCT01449955|OG000|Outcome|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
11076506|NCT01449955|OG001|Outcome|Placebo|15 mg Placebo administered once in pill form
11076507|NCT01449955|OG000|Outcome|Rapamycin (e.g., Sirolimus) Baseline|15mg Rapamycin administered once in pill form at baseline
11076508|NCT01449955|OG001|Outcome|Placebo at Baseline|15 mg Placebo administered once in pill form at baseline
11076509|NCT01449955|OG002|Outcome|Rapamycin (e.g., Sirolimus) at 3 Months Posttreatment|15mg Rapamycin administered once in pill form at 3 months Posttreatment
11076510|NCT01449955|OG003|Outcome|Placebo at 3 Months Posttreatment|15 mg Placebo administered once in pill form at 3 months posttreatment
11076511|NCT01449955|OG002|Outcome|Rapamycin (e.g., Sirolimus) at 1 Month Posttreatment|15mg Rapamycin administered once in pill form at 1 month Posttreatment
11076512|NCT01449955|OG003|Outcome|Placebo at 1 Month Posttreatment|15 mg Placebo administered once in pill form at 1 month Posttreatment
11076513|NCT01449955|OG002|Outcome|Rapamycin (e.g., Sirolimus) at 3 Months Posttreatment|15mg Rapamycin administered once in pill form at 3 months posttreatment
11076514|NCT01449955|EG000|Reported Event|Rapamycin|15mg Rapamycin
11076515|NCT01449955|EG001|Reported Event|Placebo|Placebo arm
11076516|NCT01450007|BG000|Baseline|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
11076517|NCT01450007|BG001|Baseline|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
11076518|NCT01450007|BG002|Baseline|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
11076519|NCT01450007|BG003|Baseline|Total|Total of all reporting groups
11076520|NCT01450007|FG000|Participant Flow|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
11076521|NCT01450007|FG001|Participant Flow|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
11076522|NCT01450007|FG002|Participant Flow|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
11076523|NCT01450007|OG000|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
11076524|NCT01450007|OG001|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
11076525|NCT01450007|OG002|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
11076526|NCT01450007|EG000|Reported Event|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
11076527|NCT01450007|EG001|Reported Event|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
11076528|NCT01450007|EG002|Reported Event|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
11076529|NCT01450098|BG000|Baseline|Cohort A: Fixed Sequence of Meal Conditions|LY2484595: 200 milligrams (mg) of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast.
11076530|NCT01450098|BG001|Baseline|Cohort B: Comparison of Randomized Treatments|LY2484595: 100 mg of LY2484595 administered orally as an RF tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as an SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast.
11076531|NCT01450098|BG002|Baseline|Total|Total of all reporting groups
11076532|NCT01450098|FG000|Participant Flow|Cohort A: Fixed Sequence of Meal Conditions|LY2484595: 200 milligrams (mg) of LY2484595 administered orally, one time only, as a spray-dried solid dispersion-propyl gallate (SDSD-PG) tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast.
11076533|NCT01450098|FG001|Participant Flow|Cohort B: Comparison of Randomized Treatments|LY2484595: 100 mg of LY2484595 administered orally as reference formulation (RF) tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast.
11076534|NCT01450098|OG000|Outcome|LY2484595 200 mg SDSD-PG Fasted|Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with no food
11076535|NCT01450098|OG001|Outcome|LY2484595 200 mg SDSD-PG Low Fat|Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a low-fat breakfast
11076536|NCT01450098|OG002|Outcome|LY2484595 200 mg SDSD-PG High Fat|Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a high-fat breakfast
11076537|NCT01450098|OG000|Outcome|LY2484595 100 mg RF|Cohort B: 100 mg of LY2484595 administered orally one time as an RF tablet with a low-fat breakfast
11076538|NCT01450098|OG001|Outcome|LY2484595 100 mg SDSD-PG|Cohort B: 100 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
11076539|NCT01450098|OG002|Outcome|LY2484595 200 mg SDSD-PG|Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with no food; then, after at least a 14 day washout period, 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with a low-fat breakfast; then, after a washout period of at least 14 days, 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with a high-fat breakfast
11076540|NCT01450098|OG003|Outcome|LY2484595 300 mg SDSD-PG|Cohort B: 300 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
11076541|NCT01450098|EG000|Reported Event|LY2484595 100 mg RF|Cohort B: 100 mg of LY2484595 administered orally one time as an RF tablet with a low-fat breakfast
11227396|NCT02382913|OG000|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11076542|NCT01450098|EG001|Reported Event|LY2484595 100 mg SDSD-PG|Cohort B: 100 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
11076543|NCT01450098|EG002|Reported Event|LY2484595 200 mg SDSD-PG|Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with no food; then, after at least a 14 day washout period, 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with a low-fat breakfast; then, after a washout period of at least 14 days, 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with a high-fat breakfast
11076544|NCT01450098|EG003|Reported Event|LY2484595 300 mg SDSD-PG|Cohort B: 300 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
11076545|NCT01450137|BG000|Baseline|Tocilizumab|"Tocilizumab 8mg/kg every 4 weeks until week 52.~Tocilizumab + Glucocorticoids (GCs): Tocilizumab 8mg/kg every 4 weeks until week 52."
11076546|NCT01450137|BG001|Baseline|Placebo|"Placebo every 4 weeks until week 52.~Placebo + Glucocorticoids (GCs): Placebo every 4 weeks until week 52."
11076547|NCT01450137|BG002|Baseline|Total|Total of all reporting groups
11076548|NCT01450137|FG000|Participant Flow|Tocilizumab|"Tocilizumab 8mg/kg every 4 weeks until week 52.~Tocilizumab + Glucocorticoids (GCs): Tocilizumab 8mg/kg every 4 weeks until week 52."
11076549|NCT01450137|FG001|Participant Flow|Placebo|"Placebo every 4 weeks until week 52.~Placebo + Glucocorticoids (GCs): Placebo every 4 weeks until week 52."
11076550|NCT01450137|OG000|Outcome|Tocilizumab|"Tocilizumab 8mg/kg every 4 weeks until week 52.~Tocilizumab + Glucocorticoids (GCs): Tocilizumab 8mg/kg every 4 weeks until week 52."
11076551|NCT01450137|OG001|Outcome|Placebo|"Placebo every 4 weeks until week 52.~Placebo + Glucocorticoids (GCs): Placebo every 4 weeks until week 52."
11076552|NCT01450137|EG000|Reported Event|Tocilizumab|"Tocilizumab 8mg/kg every 4 weeks until week 52.~Tocilizumab + Glucocorticoids (GCs): Tocilizumab 8mg/kg every 4 weeks until week 52."
11076553|NCT01450137|EG001|Reported Event|Placebo|"Placebo every 4 weeks until week 52.~Placebo + Glucocorticoids (GCs): Placebo every 4 weeks until week 52."
11076554|NCT01450189|BG000|Baseline|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
11076555|NCT01450189|BG001|Baseline|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
11076556|NCT01450189|BG002|Baseline|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
11076557|NCT01450189|BG003|Baseline|Total|Total of all reporting groups
11076558|NCT01450189|FG000|Participant Flow|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
11076559|NCT01450189|FG001|Participant Flow|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
11076560|NCT01450189|FG002|Participant Flow|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
11076561|NCT01450189|OG000|Outcome|Overall|All arms combined
11076562|NCT01450189|OG000|Outcome|Overall|
11076563|NCT01450189|OG000|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
11173611|NCT02016612|BG001|Baseline|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173612|NCT02016612|BG002|Baseline|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11076564|NCT01450189|OG001|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
11076565|NCT01450189|OG002|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
11076566|NCT01450189|OG000|Outcome|Combined Behavioral Intervention Arms|Both the behavioral intervention and behavioral intervention plus antiretroviral arms are combined in this outcome
11349120|NCT04117607|FG004|Participant Flow|SAD5|"100 mg (1 injection of 1.0 mL) of Rezafungin administered subcutaneously as a single dose, on Day 1 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11349121|NCT04117607|FG005|Participant Flow|SAD6|"200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously into the same abdominal quadrant (separated by approximately 5 cm) as a single dose, on Day 1 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11349122|NCT04117607|FG006|Participant Flow|SAD Placebo|"Placebo participants across all SAD cohorts: 1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP), 10 mg (1 injection of 0.1 ml), 30 mg (1 injection of 0.3 ml), 60 mg (1 injection of 0.6 ml), 100 mg (1 injection of 1 ml), or 200 mg (2 injections of 1 ml) of matching placebo administered subcutaneously as a single dose in a double-blind manner on Day 1 in a double-blind manner.~The 200 mg dose injections will be administered in the same abdominal quadrant, separated by approximately 5 cm.~Placebo: 5% Dextrose Injection, USP, a sterile, nonpyrogenic solution of dextrose in water for injection. The solution has the osmolarity of 252 mOsmol/L, which is slightly hypotonic. This solution contains no bacteriostat, antimicrobial agent or added buffer."
11357469|NCT03757234|EG001|Reported Event|Omadacycline 200 iv/100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
11076567|NCT01450189|OG000|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
11076568|NCT01450189|OG001|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
11076569|NCT01450189|OG002|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
11150305|NCT01876992|BG000|Baseline|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm~, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.~Metformin"
11173613|NCT02016612|BG003|Baseline|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173614|NCT02016612|BG004|Baseline|Total|Total of all reporting groups
11076570|NCT01450189|OG002|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
11349123|NCT04117607|FG007|Participant Flow|MAD1|"30 mg (1 injection of 0.3 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11076571|NCT01450189|EG000|Reported Event|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
11076572|NCT01450189|EG001|Reported Event|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
11076573|NCT01450189|EG002|Reported Event|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
11076574|NCT01450306|BG000|Baseline|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
11076575|NCT01450306|BG001|Baseline|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
11076576|NCT01450306|BG002|Baseline|Total|Total of all reporting groups
11076577|NCT01450306|FG000|Participant Flow|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
11076578|NCT01450306|FG001|Participant Flow|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
11076579|NCT01450306|OG000|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
11076580|NCT01450306|OG001|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
11076581|NCT01450306|EG000|Reported Event|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
11076582|NCT01450306|EG001|Reported Event|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
11076583|NCT01450319|BG000|Baseline|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
11076584|NCT01450319|FG000|Participant Flow|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
11076585|NCT01450319|OG000|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
11076586|NCT01450319|EG000|Reported Event|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
11076587|NCT01450397|BG000|Baseline|XIAFLEX|Patient who have received XIAFLEX
11076588|NCT01450397|FG000|Participant Flow|XIAFLEX|0.58 mg of Xiaflex injected into a palpable Dupuytren's cord
11076589|NCT01450397|OG000|Outcome|XIAFLEX|Subjects receiving one Xiaflex injection
11076590|NCT01450397|EG000|Reported Event|XIAFLEX|Patient who received XIAFLEX
11076591|NCT01450540|BG000|Baseline|Group 1|"REMStar auto A-Flex~REMstar Auto A-Flex: Standard CPAP"
11076592|NCT01450540|BG001|Baseline|Group 2|"modified REMstar Auto A-Flex with AGPAP~modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12"
11076593|NCT01450540|BG002|Baseline|Total|Total of all reporting groups
11076594|NCT01450540|FG000|Participant Flow|Group 1|"REMStar auto A-Flex~REMstar Auto A-Flex: Standard CPAP"
11076595|NCT01450540|FG001|Participant Flow|Group 2|"modified REMstar Auto A-Flex with AGPAP~modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12"
11076596|NCT01450540|OG000|Outcome|Group 1|"REMStar auto A-Flex~REMstar Auto A-Flex: Standard CPAP"
11076597|NCT01450540|OG001|Outcome|Group 2|"modified REMstar Auto A-Flex with AGPAP~modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12"
11076598|NCT01450540|OG000|Outcome|Group 1- Standard CPAP|"REMStar auto A-Flex~REMstar Auto A-Flex: Standard CPAP"
11076599|NCT01450540|OG001|Outcome|Group 2 -AGPAP|"modified REMstar Auto A-Flex with AGPAP~modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12"
11076600|NCT01450540|EG000|Reported Event|Group 1- Standard CPAP|"REMStar auto A-Flex~REMstar Auto A-Flex: Standard CPAP"
11076601|NCT01450540|EG001|Reported Event|Group 2 -AGPAP|"modified REMstar Auto A-Flex with AGPAP~modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12"
11076602|NCT01450631|BG000|Baseline|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
11076603|NCT01450631|BG001|Baseline|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
11076604|NCT01450631|BG002|Baseline|Total|Total of all reporting groups
11076605|NCT01450631|FG000|Participant Flow|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
11076606|NCT01450631|FG001|Participant Flow|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
11076607|NCT01450631|OG000|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
11076608|NCT01450631|OG001|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
11150306|NCT01876992|BG001|Baseline|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
11076609|NCT01450631|EG000|Reported Event|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
11076610|NCT01450631|EG001|Reported Event|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
11076611|NCT01450683|BG000|Baseline|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
11076612|NCT01450683|FG000|Participant Flow|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
11076613|NCT01450683|OG000|Outcome|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
11076614|NCT01450683|EG000|Reported Event|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
11076615|NCT01450696|BG000|Baseline|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
11076616|NCT01450696|BG001|Baseline|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
11076617|NCT01450696|BG002|Baseline|Total|Total of all reporting groups
11076618|NCT01450696|FG000|Participant Flow|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 followed by 6 mg/kg every three weeks (q3w) as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 milligrams per meter-squared (mg/m^2) intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
11076619|NCT01450696|FG001|Participant Flow|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
11076620|NCT01450696|OG000|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
11076621|NCT01450696|OG001|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
11076622|NCT01450696|EG000|Reported Event|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
11150307|NCT01876992|BG002|Baseline|Total|Total of all reporting groups
11173615|NCT02016612|FG000|Participant Flow|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11076623|NCT01450696|EG001|Reported Event|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
11076624|NCT01450761|BG000|Baseline|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
11076625|NCT01450761|BG001|Baseline|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
11076626|NCT01450761|BG002|Baseline|Total|Total of all reporting groups
11076627|NCT01450761|FG000|Participant Flow|Ipilimumab and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
11076628|NCT01450761|FG001|Participant Flow|Placebo and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
11076629|NCT01450761|OG000|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
11076630|NCT01450761|OG001|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
11076631|NCT01450761|EG000|Reported Event|10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE|
11076632|NCT01450761|EG001|Reported Event|PLACEBO + PLATINUM/ETOPOSIDE|
11076633|NCT01450787|BG000|Baseline|Diabetics|diabetics over age 40
11076634|NCT01450787|BG001|Baseline|Non Diabetics|non diabetics over age 40
11076635|NCT01450787|BG002|Baseline|Total|Total of all reporting groups
11076636|NCT01450787|FG000|Participant Flow|Diabetics|diabetics over age 40
11076637|NCT01450787|FG001|Participant Flow|Non Diabetics|non diabetics over age 40
11076638|NCT01450787|OG000|Outcome|Diabetics|diabetics over age 40
11076639|NCT01450787|OG001|Outcome|Non Diabetics|non diabetics over age 40
11076640|NCT01450787|EG000|Reported Event|Diabetics|diabetics over age 40
11076641|NCT01450787|EG001|Reported Event|Non Diabetics|non diabetics over age 40
11076642|NCT01450800|BG000|Baseline|Nitrofurantoin|Participants randomized to receive antibiotics instructed to take nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
11076643|NCT01450800|BG001|Baseline|Placebo|Participants randomized to receive placebo instructed to take placebo 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
11076644|NCT01450800|BG002|Baseline|Total|Total of all reporting groups
11076645|NCT01450800|FG000|Participant Flow|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily for each day of catheterization for up to 7 days
11076646|NCT01450800|FG001|Participant Flow|Placebo|Randomized to placebo 1 tablet daily for each day of catheterization for up to 7 days
11076647|NCT01450800|OG000|Outcome|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily while using a catheter for up to 7 days
11076648|NCT01450800|OG001|Outcome|Placebo|Randomized to placebo 1 tab daily while using a catheter for up to 7 days
11076649|NCT01450800|OG000|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
11076650|NCT01450800|OG000|Outcome|Urine Cultures Performed|All participants in the final analysis were examined
11076651|NCT01450800|EG000|Reported Event|Nitrofurantoin|Participants randomized to receive nitrofurantoin 100mg by mouth daily each day of catheterization for up to one week after surgery
11076652|NCT01450800|EG001|Reported Event|Placebo|Participants randomized to receive placebo 1 tablet by mouth daily each day of catheterization for up to one week after surgery
11076653|NCT01450813|BG000|Baseline|Group 1|Rocuronium dose 0 mg/kg prior to laryngoscopy
11076654|NCT01450813|BG001|Baseline|Group 2|Rocuronium dose 0.2 mg/kg prior to laryngoscopy
11076655|NCT01450813|BG002|Baseline|Group 3|Rocuronium dose 0.4 mg/kg prior to laryngoscopy
11076656|NCT01450813|BG003|Baseline|Group 4|Rocuronium dose 0.6 mg/kg prior to laryngoscopy
11076657|NCT01450813|BG004|Baseline|Total|Total of all reporting groups
11076658|NCT01450813|FG000|Participant Flow|Group 1|Saline 0.06 ml/kg
11076659|NCT01450813|FG001|Participant Flow|Group 2|Rocuronium 0.2 mg/kg
11076660|NCT01450813|FG002|Participant Flow|Group 3|Rocuronium 0.4 mg/kg
11076661|NCT01450813|FG003|Participant Flow|Group 4|Rocuronium 0.6 mg/kg
11076662|NCT01450813|OG000|Outcome|Group 1|Rocuronium 0mg/kg
11076663|NCT01450813|OG001|Outcome|Group 2|Rocuronium 0.2mg/kg
11076664|NCT01450813|OG002|Outcome|Group 3|Rocuronium 0.4mg/kg
11076665|NCT01450813|OG003|Outcome|Group 4|Rocuronium 0.6mg/kg
11076666|NCT01450813|OG000|Outcome|Remifentanil 2ng/ml|The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
11076667|NCT01450813|OG001|Outcome|Remifentanil 8 ng/ml|The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
11076668|NCT01450813|EG000|Reported Event|Group 1|Rocuronium dose 0 mg/kg
11076669|NCT01450813|EG001|Reported Event|Group 2|Rocuronium dose 0.2 mg/kg
11076670|NCT01450813|EG002|Reported Event|Group 3|Rocuronium dose 0.4 mg/kg
11076671|NCT01450813|EG003|Reported Event|Group 4|Rocuronium dose 0.6 mg/kg
11076672|NCT01450826|BG000|Baseline|Aprepitant+Ondansetron|"On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.~Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).~Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen."
11076673|NCT01450826|BG001|Baseline|Ondansetron|"On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.~Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen."
11076674|NCT01450826|BG002|Baseline|Total|Total of all reporting groups
11076675|NCT01450826|FG000|Participant Flow|Aprepitant+Ondansetron|"On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.~Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).~Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen."
11076676|NCT01450826|FG001|Participant Flow|Ondansetron|"On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.~Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen."
11076677|NCT01450826|OG000|Outcome|Aprepitant+Ondansetron|"On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.~Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).~Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen."
11076678|NCT01450826|OG001|Outcome|Ondansetron|"On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.~Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen."
11076679|NCT01450826|EG000|Reported Event|Aprepitant+Ondansetron|"On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.~Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).~Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen."
11076680|NCT01450826|EG001|Reported Event|Ondansetron Alone|"On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.~Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen."
11076681|NCT01450943|BG000|Baseline|Standard of Care|Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
11076682|NCT01450943|BG001|Baseline|Dermagraft|"Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.~The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.~Dermagraft placed per company protocol"
11076683|NCT01450943|BG002|Baseline|Oasis|"Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.~The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.~Oasis placed per company protocol"
11076684|NCT01450943|BG003|Baseline|Total|Total of all reporting groups
11076685|NCT01450943|FG000|Participant Flow|Standard of Care|Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
10887661|NCT00502216|OG001|Outcome|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
11076686|NCT01450943|FG001|Participant Flow|Dermagraft|"These are study subject who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.~The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.~Dermagraft placed per company protocol"
11076687|NCT01450943|FG002|Participant Flow|Oasis|"These are study subject who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.~The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.~Oasis placed per company protocol"
11076688|NCT01450943|OG000|Outcome|Standard of Care|Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape without any grafts.
11076689|NCT01450943|OG001|Outcome|Dermagraft|"Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.~The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.~Dermagraft placed per company protocol"
11076690|NCT01450943|OG002|Outcome|Oasis|"Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.~The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.~Oasis placed per company protocol"
11076691|NCT01450943|OG000|Outcome|Standard of Care|Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
11076692|NCT01450943|OG000|Outcome|Standard of Care|"SOC Group:~debridement, irrigation , PRIMARY dressing and Adaptic, SECONDARY dressing gauze and tape~SECONDARY dressing gauze and tape: SECONDARY dressing gauze and tape~debridement, irrigation: debridement, irrigation"
11076693|NCT01450943|OG001|Outcome|Dermagraft|"Dermagraft Group: debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape~SECONDARY dressing gauze and tape: SECONDARY dressing gauze and tape~debridement, irrigation: debridement, irrigation~Dermagraft: Dermagraft per company protocol"
11076694|NCT01450943|OG002|Outcome|Oasis|"Oasis Group:~debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape~SECONDARY dressing gauze and tape: SECONDARY dressing gauze and tape~debridement, irrigation: debridement, irrigation~Oasis: Oasis per company protocol"
11076695|NCT01450943|EG000|Reported Event|Standard of Care|Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
11076696|NCT01450943|EG001|Reported Event|Dermagraft|"Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.~The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.~Dermagraft placed per company protocol"
11076697|NCT01450943|EG002|Reported Event|Oasis|"Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.~The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.~Oasis placed per company protocol"
11091875|NCT01536561|OG000|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
11091876|NCT01536561|OG001|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
11150308|NCT01876992|FG000|Participant Flow|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.~Metformin"
11076698|NCT01451164|BG000|Baseline|Brexpiprazole 1mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
11076699|NCT01451164|BG001|Baseline|Brexpiprazole 2mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
11076700|NCT01451164|BG002|Baseline|Brexpiprazole 4mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
11076701|NCT01451164|BG003|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
11076702|NCT01451164|BG004|Baseline|Total|Total of all reporting groups
11076703|NCT01451164|FG000|Participant Flow|Brexpiprazole 1mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
11076704|NCT01451164|FG001|Participant Flow|Brexpiprazole 2mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
11076705|NCT01451164|FG002|Participant Flow|Brexpiprazole 4mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
11076706|NCT01451164|FG003|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
11076707|NCT01451164|OG000|Outcome|Brexpiprazole 1mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
11076708|NCT01451164|OG001|Outcome|Brexpiprazole 2mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
11076709|NCT01451164|OG002|Outcome|Brexpiprazole 4mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
11076710|NCT01451164|OG003|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
11076711|NCT01451164|EG000|Reported Event|Brexpiprazole 1mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
11076712|NCT01451164|EG001|Reported Event|Brexpiprazole 2mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
11076713|NCT01451164|EG002|Reported Event|Brexpiprazole 4mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
11076714|NCT01451164|EG003|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
11076715|NCT01451203|BG000|Baseline|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
11076716|NCT01451203|BG001|Baseline|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
11076717|NCT01451203|BG002|Baseline|Total|Total of all reporting groups
11076718|NCT01451203|FG000|Participant Flow|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
11076719|NCT01451203|FG001|Participant Flow|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
11076720|NCT01451203|OG000|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
11076721|NCT01451203|OG001|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
11076722|NCT01451203|EG000|Reported Event|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
11076723|NCT01451203|EG001|Reported Event|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
11076724|NCT01451372|BG000|Baseline|Type 1 Diabetes Subjects Using CGM|Type 1 Diabetes Subjects using CGM in Sweden
11076725|NCT01451372|FG000|Participant Flow|Type 1 Diabetes Subjects Using CGM|Type 1 Diabetes Subjects using CGM in Sweden
11076726|NCT01451372|OG000|Outcome|Type 1 Diabetes Subjects Using CGM|Type 1 Diabetes Subjects using CGM in Sweden
11076727|NCT01451372|EG000|Reported Event|Type 1 Diabetes Subjects Using CGM|Type 1 Diabetes Subjects using CGM in Sweden
11076728|NCT01451385|BG000|Baseline|All Participants|All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
11076729|NCT01451385|FG000|Participant Flow|All Participants|All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
11076730|NCT01451385|OG000|Outcome|All Participants|All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
11076731|NCT01451385|EG000|Reported Event|All Participants|All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
11076732|NCT01451398|BG000|Baseline|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
11076733|NCT01451398|BG001|Baseline|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
11076734|NCT01451398|BG002|Baseline|Total|Total of all reporting groups
11076735|NCT01451398|FG000|Participant Flow|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
11076736|NCT01451398|FG001|Participant Flow|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
11076737|NCT01451398|OG000|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
11076738|NCT01451398|OG001|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
11076739|NCT01451398|EG000|Reported Event|TI Inhalation Powder|"Technosphere® Insulin powder administered via the Gen2 inhaler added to 1 - 3 stable OADs~Technosphere® Insulin: Technosphere® Insulin Inhalation Powder"
11076740|NCT01451398|EG001|Reported Event|Technosphere Powder|"technosphere powder (with no insulin) administered via the Gen2 inhaler added to 1 - 3 stable OADs~Technosphere Powder: Placebo Comparator"
11076741|NCT01451411|BG000|Baseline|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
11076742|NCT01451411|BG001|Baseline|Placebo|Placebo: Intravenous
11076743|NCT01451411|BG002|Baseline|Total|Total of all reporting groups
11076744|NCT01451411|FG000|Participant Flow|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
11076745|NCT01451411|FG001|Participant Flow|Placebo|Placebo: Intravenous
11076746|NCT01451411|OG000|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
11076747|NCT01451411|OG001|Outcome|Placebo|Placebo: Intravenous
11076748|NCT01451411|EG000|Reported Event|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
11076749|NCT01451411|EG001|Reported Event|Placebo|Placebo: Intravenous
11076750|NCT01451424|BG000|Baseline|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
11076751|NCT01451424|BG001|Baseline|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
11076752|NCT01451424|BG002|Baseline|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 weeks Includes subjects from both arms 1 and 3 (PK group and non-PK groups)"
11076753|NCT01451424|BG003|Baseline|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
11076754|NCT01451424|BG004|Baseline|Total|Total of all reporting groups
11076755|NCT01451424|FG000|Participant Flow|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks~All subjects completed the placebo run-in period and started active dosing."
11076756|NCT01451424|FG001|Participant Flow|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks~All subjects completed the placebo run-in period and started active dosing."
11076757|NCT01451424|FG002|Participant Flow|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1, PK group) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks~The first 6 subjects (arm 1) had no placebo run-in period. Arm 3 subjects all completed the placebo run-in period and started active dosing."
11076758|NCT01451424|FG003|Participant Flow|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks~All subjects completed the placebo run-in period and started active dosing."
11076759|NCT01451424|OG000|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
11076760|NCT01451424|OG001|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
11076761|NCT01451424|OG002|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
11076762|NCT01451424|OG003|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
11076763|NCT01451424|OG000|Outcome|Proellex 12 mg PK Group|"Subjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period.~Proellex: vaginal suppository, daily, for 12 weeks"
11076764|NCT01451424|OG001|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
11076765|NCT01451424|OG002|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
11076766|NCT01451424|OG003|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
11076767|NCT01451424|OG004|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
11076768|NCT01451424|EG000|Reported Event|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
11076769|NCT01451424|EG001|Reported Event|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
11076770|NCT01451424|EG002|Reported Event|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
11076771|NCT01451424|EG003|Reported Event|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 12 weeks"
11076772|NCT01451437|BG000|Baseline|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076773|NCT01451437|BG001|Baseline|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076774|NCT01451437|BG002|Baseline|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076775|NCT01451437|BG003|Baseline|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076776|NCT01451437|BG004|Baseline|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
11076777|NCT01451437|BG005|Baseline|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
11076778|NCT01451437|BG006|Baseline|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
11076779|NCT01451437|BG007|Baseline|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
11076780|NCT01451437|BG008|Baseline|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
11076781|NCT01451437|BG009|Baseline|Total|Total of all reporting groups
11076782|NCT01451437|FG000|Participant Flow|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076783|NCT01451437|FG001|Participant Flow|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076784|NCT01451437|FG002|Participant Flow|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076785|NCT01451437|FG003|Participant Flow|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076786|NCT01451437|FG004|Participant Flow|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
11076787|NCT01451437|FG005|Participant Flow|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
11076788|NCT01451437|FG006|Participant Flow|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
11076789|NCT01451437|FG007|Participant Flow|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
11076790|NCT01451437|FG008|Participant Flow|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
11076791|NCT01451437|OG000|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076792|NCT01451437|OG001|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076793|NCT01451437|OG002|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076794|NCT01451437|OG003|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076795|NCT01451437|OG004|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
11076796|NCT01451437|OG005|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
11076797|NCT01451437|OG006|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
11076798|NCT01451437|OG007|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
11076799|NCT01451437|OG008|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
10887662|NCT00502216|EG000|Reported Event|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
11076800|NCT01451437|OG000|Outcome|Pt 2 Arm A: MK-8242 30 mg QD|Participants to receive MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
11076801|NCT01451437|OG001|Outcome|Pt 2 Arm A: MK-8242 60 mg QD|Participants to receive MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
11076802|NCT01451437|OG002|Outcome|Pt 2 Arm A: MK-8242 120 mg QD|Participants to receive MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
11076803|NCT01451437|OG003|Outcome|Pt 2 Arm A: MK-8242 250 mg QD|Participants to receive MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
11076804|NCT01451437|OG004|Outcome|Pt 2 Arm A: MK-8242 120 mg BID|Participants to receive MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg to be administered QD in the morning) in Part 2 Arm A.
11076805|NCT01451437|OG005|Outcome|Pt 2 Arm A: MK-8242 170 mg BID|Participants to receive MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg to be administered QD in the morning) in Part 2 Arm A.
11076806|NCT01451437|OG006|Outcome|Pt 2 Arm A: MK-8242 210 mg BID|Participants to receive MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg to be administered QD in the morning) in Part 2 Arm A.
11076807|NCT01451437|OG007|Outcome|Pt 2 Arm A: MK-8242 250 mg BID|Participants to receive MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg to be administered QD in the morning) in Part 2 Arm A.
11076808|NCT01451437|OG008|Outcome|Pt 2 Arm A: MK-8242 300 mg BID|Participants to receive MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg to be administered QD in the morning) in Part 2 Arm A.
11076809|NCT01451437|EG000|Reported Event|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076810|NCT01451437|EG001|Reported Event|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076811|NCT01451437|EG002|Reported Event|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11227397|NCT02382913|OG001|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227398|NCT02382913|OG002|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227399|NCT02382913|OG000|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227400|NCT02382913|OG001|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11076812|NCT01451437|EG003|Reported Event|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
11076813|NCT01451437|EG004|Reported Event|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
11076814|NCT01451437|EG005|Reported Event|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
11076815|NCT01451437|EG006|Reported Event|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
11076816|NCT01451437|EG007|Reported Event|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
11076817|NCT01451437|EG008|Reported Event|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
11076818|NCT01451463|BG000|Baseline|Individuals on Stable Doses of Tetrabenazine|11 Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
11076819|NCT01451463|FG000|Participant Flow|Individuals on Stable Doses of Tetrabenazine|Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
11076820|NCT01451463|OG000|Outcome|Individuals 2 Hours After Resuming Tetrabenazine|11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test following resumption of medication > 18 hours after being off their regular stable dose of medication.
11076821|NCT01451463|OG001|Outcome|Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr|11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test after being off their stable dose of medication for > 18 hours
11076822|NCT01451463|OG000|Outcome|Individuals 2 Hours After Resuming Tetrabenazine|11 Individuals on stable doses of tetrabenazine were studied on the 5 times sit to stand test following resumption of medication . > 18 hours after being off their medication.
11076823|NCT01451463|OG001|Outcome|Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr|11 Individuals on stable doses of tetrabenazine were studied on the 5 times sit to stand test while off medication
11076824|NCT01451463|OG000|Outcome|Individuals Resuming Their Stable Doses of Tetrabenazine|11 Individuals on stable doses of tetrabenazine were studied two hours after resuming their medication after being off medication for > 18 hours.
11227401|NCT02382913|OG002|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227402|NCT02382913|EG000|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227403|NCT02382913|EG001|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227404|NCT02382913|EG002|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227405|NCT02382913|EG003|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227406|NCT02382913|EG004|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11076825|NCT01451463|OG001|Outcome|Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr|11 Individuals who have been on stable doses of tetrabenazine were studied after being off medication for > 18 hours.
11076826|NCT01451463|EG000|Reported Event|Individuals on Stable Doses of Tetrabenazine|Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
11076827|NCT01451541|BG000|Baseline|Placebo|Placebo: placebo - one dose per nostril
11076828|NCT01451541|BG001|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
11076829|NCT01451541|BG002|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
11076830|NCT01451541|BG003|Baseline|Total|Total of all reporting groups
11076831|NCT01451541|FG000|Participant Flow|Placebo|Placebo: placebo - one dose per nostril
11076832|NCT01451541|FG001|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
11076833|NCT01451541|FG002|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
11076834|NCT01451541|OG000|Outcome|Placebo|Placebo: placebo - one dose per nostril
11076835|NCT01451541|OG001|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
11076836|NCT01451541|OG002|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
11076837|NCT01451541|OG000|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
11076838|NCT01451541|OG001|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
11076839|NCT01451541|EG000|Reported Event|Placebo|Placebo: placebo - one dose per nostril
11076840|NCT01451541|EG001|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
11076841|NCT01451541|EG002|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
11076842|NCT01451554|BG000|Baseline|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
11076843|NCT01451554|BG001|Baseline|Usual Care|Provided with self-help booklets on diet and exercise.
11076844|NCT01451554|BG002|Baseline|Total|Total of all reporting groups
11076845|NCT01451554|FG000|Participant Flow|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
11076846|NCT01451554|FG001|Participant Flow|Usual Care|Provided with self-help booklets on diet and exercise.
11076847|NCT01451554|OG000|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
11076848|NCT01451554|OG001|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
11076849|NCT01451554|EG000|Reported Event|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
11076850|NCT01451554|EG001|Reported Event|Usual Care|Provided with self-help booklets on diet and exercise.
11076851|NCT01451606|BG000|Baseline|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
11076852|NCT01451606|BG001|Baseline|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
11076853|NCT01451606|BG002|Baseline|Total|Total of all reporting groups
11076854|NCT01451606|FG000|Participant Flow|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
11076855|NCT01451606|FG001|Participant Flow|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
11076856|NCT01451606|OG000|Outcome|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
11076857|NCT01451606|OG001|Outcome|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
11076858|NCT01451606|EG000|Reported Event|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
11076859|NCT01451606|EG001|Reported Event|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
11076860|NCT01451632|BG000|Baseline|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
11076861|NCT01451632|BG001|Baseline|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
11076862|NCT01451632|BG002|Baseline|Total|Total of all reporting groups
11076863|NCT01451632|FG000|Participant Flow|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
11076864|NCT01451632|FG001|Participant Flow|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
11076865|NCT01451632|FG002|Participant Flow|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
11076866|NCT01451632|FG003|Participant Flow|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
11076867|NCT01451632|FG004|Participant Flow|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
11076868|NCT01451632|FG005|Participant Flow|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
11076869|NCT01451632|FG006|Participant Flow|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
11076870|NCT01451632|FG007|Participant Flow|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
11076871|NCT01451632|FG008|Participant Flow|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
11076872|NCT01451632|FG009|Participant Flow|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
11076873|NCT01451632|OG000|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
11076874|NCT01451632|OG001|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
11076875|NCT01451632|OG002|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
11076876|NCT01451632|OG003|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
11076877|NCT01451632|OG004|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
11357470|NCT03757234|EG002|Reported Event|Omadacycline 200 iv/300 po or 100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
11076878|NCT01451632|OG005|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
11076879|NCT01451632|OG006|Outcome|Part 2: Cohort 1|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
11076880|NCT01451632|OG007|Outcome|Part 2: Cohort 2|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
11076881|NCT01451632|OG000|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
11076882|NCT01451632|OG001|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
11076883|NCT01451632|OG000|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
11076884|NCT01451632|OG005|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
11076885|NCT01451632|OG006|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
11076886|NCT01451632|OG007|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
11076887|NCT01451632|OG008|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
11076888|NCT01451632|OG009|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
11076889|NCT01451632|OG000|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
11076890|NCT01451632|OG001|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
11076891|NCT01451632|OG002|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
11076892|NCT01451632|OG003|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
11076893|NCT01451632|OG004|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
11076894|NCT01451632|EG000|Reported Event|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
11076895|NCT01451632|EG001|Reported Event|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
11076896|NCT01451645|BG000|Baseline|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
11076897|NCT01451645|BG001|Baseline|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
11076898|NCT01451645|BG002|Baseline|Total|Total of all reporting groups
11076899|NCT01451645|FG000|Participant Flow|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
11076900|NCT01451645|FG001|Participant Flow|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
11076901|NCT01451645|OG000|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
11076902|NCT01451645|OG001|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
11076903|NCT01451645|EG000|Reported Event|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
11076904|NCT01451645|EG001|Reported Event|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
11076905|NCT01451749|BG000|Baseline|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
11076906|NCT01451749|BG001|Baseline|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
11076907|NCT01451749|BG002|Baseline|Total|Total of all reporting groups
11076908|NCT01451749|FG000|Participant Flow|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
11076909|NCT01451749|FG001|Participant Flow|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
11076910|NCT01451749|OG000|Outcome|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
11076911|NCT01451749|OG001|Outcome|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
11076912|NCT01451749|OG000|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
11076913|NCT01451749|OG001|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
11076914|NCT01451749|EG000|Reported Event|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
11076915|NCT01451749|EG001|Reported Event|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
10849884|NCT00299104|OG002|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
11076916|NCT01451762|BG000|Baseline|Placebo|.9 normal saline IV
11076917|NCT01451762|BG001|Baseline|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
11076918|NCT01451762|BG002|Baseline|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
11076919|NCT01451762|BG003|Baseline|Total|Total of all reporting groups
11076920|NCT01451762|FG000|Participant Flow|Placebo|.9 normal saline IV
11076921|NCT01451762|FG001|Participant Flow|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
11076922|NCT01451762|FG002|Participant Flow|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
11076923|NCT01451762|OG000|Outcome|Placebo|.9 normal saline IV
11076924|NCT01451762|OG001|Outcome|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
11076925|NCT01451762|OG002|Outcome|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
11076926|NCT01451762|EG000|Reported Event|Placebo|.9 normal saline IV
11076927|NCT01451762|EG001|Reported Event|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
11076928|NCT01451762|EG002|Reported Event|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
11076929|NCT01451775|BG000|Baseline|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments.
11076930|NCT01451775|FG000|Participant Flow|Empa 25mg Fasted / Empa 25mg Fed / Empa 10mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 10 mg empa after an overnight fast of at least 10 hours."
11076931|NCT01451775|FG001|Participant Flow|Empa 25mg Fasted / Empa 10mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
11076932|NCT01451775|FG002|Participant Flow|Empa 25mg Fed / Empa 25mg Fasted / Empa 10mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 10 mg empa after an overnight fast of at least 10 hours."
11076933|NCT01451775|FG003|Participant Flow|Empa 25mg Fed / Empa 10mg Fasted / Empa 25mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
11076934|NCT01451775|FG004|Participant Flow|Empa 10mg Fasted / Empa 25mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
11076935|NCT01451775|FG005|Participant Flow|Empa 10mg Fasted / Empa 25mg Fed / Empa 25mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
11076936|NCT01451775|OG000|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
11076937|NCT01451775|OG001|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
11076938|NCT01451775|OG002|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
11076939|NCT01451775|EG000|Reported Event|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
11076940|NCT01451775|EG001|Reported Event|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
11227407|NCT02382913|EG005|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11076941|NCT01451775|EG002|Reported Event|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
11076942|NCT01451814|BG000|Baseline|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
11076943|NCT01451814|BG001|Baseline|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
11076944|NCT01451814|BG002|Baseline|Total|Total of all reporting groups
11076945|NCT01451814|FG000|Participant Flow|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
11076946|NCT01451814|FG001|Participant Flow|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
11076947|NCT01451814|OG000|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
11076948|NCT01451814|OG001|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
11227408|NCT02382913|EG006|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227409|NCT02382913|EG007|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11076949|NCT01451814|EG000|Reported Event|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
11076950|NCT01451814|EG001|Reported Event|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
11076951|NCT01451827|BG000|Baseline|Tolvaptan MR 50 mg|"Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (morning) and 1 placebo IR tablet (evening)~Tolvaptan MR: 50/80 mg capsules~Placebo: tablet"
11076952|NCT01451827|BG001|Baseline|Tolvaptan MR 80 mg|"Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (morning) and 1 placebo IR tablet (evening)~Tolvaptan MR: 50/80 mg capsules~Placebo: tablet"
11076953|NCT01451827|BG002|Baseline|Tolvaptan IR 60/30 mg|"Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (morning) and 1 tolvaptan IR 30-mg tablet (PM)~Tolvaptan IR: 60/30 mg capsules~Placebo: tablet"
11076954|NCT01451827|BG003|Baseline|Placebo|"Placebo MR capsule and 2 placebo IR tablets (evening) and 1 placebo IR tablet (morning)~Placebo: tablet"
11076955|NCT01451827|BG004|Baseline|Total|Total of all reporting groups
11076956|NCT01451827|FG000|Participant Flow|Tolvaptan Modifed Release (MR) 50 mg|"Tolvaptan MR 50 mg capsule and 2 placebo immediate release (IR) tablets (morning) and 1 placebo IR tablet (evening)~Tolvaptan MR: 50/80 mg capsules~Placebo: tablet"
11076957|NCT01451827|FG001|Participant Flow|Tolvaptan MR 80 mg|"Tolvaptan MR 80 mg capsule and 2 placebo immediate release (IR) tablets (morning) and 1 placebo IR tablet (evening)~Tolvaptan MR: 50/80 mg capsules~Placebo: tablet"
11076958|NCT01451827|FG002|Participant Flow|Tolvaptan Immediate Release (IR) 60/30 mg|"Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (morning) and 1 tolvaptan IR 30-mg tablet (evening)~Tolvaptan IR: 60/30 mg capsules~Placebo: tablet"
11076959|NCT01451827|FG003|Participant Flow|Placebo|"Placebo MR capsule and 2 placebo IR tablets (morning) and 1 placebo IR tablet (evening)~Placebo: tablet"
10849885|NCT00299104|EG000|Reported Event|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
11076960|NCT01451827|OG000|Outcome|Tolvaptan MR 50 mg|"Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)~Tolvaptan MR: 50/80 mg capsules~Placebo: tablet"
11076961|NCT01451827|OG001|Outcome|Tolvaptan MR 80 mg|"Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)~Tolvaptan MR: 50/80 mg capsules~Placebo: tablet"
11076962|NCT01451827|OG002|Outcome|Tolvaptan IR 60/30 mg|"Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (AM) and 1 tolvaptan IR 30-mg tablet (PM)~Tolvaptan IR: 60/30 mg capsules~Placebo: tablet"
11076963|NCT01451827|OG003|Outcome|Placebo|"Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)~Placebo: tablet"
11076964|NCT01451827|EG000|Reported Event|Tolvaptan MR 50 mg|"Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)~Tolvaptan MR: 50/80 mg capsules~Placebo: tablet"
11076965|NCT01451827|EG001|Reported Event|Tolvaptan MR 80 mg|"Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)~Tolvaptan MR: 50/80 mg capsules~Placebo: tablet"
11076966|NCT01451827|EG002|Reported Event|Tolvaptan IR 60/30 mg|"Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (AM) and 1 tolvaptan IR 30-mg tablet (PM)~Tolvaptan IR: 60/30 mg capsules~Placebo: tablet"
11076967|NCT01451827|EG003|Reported Event|Placebo|"Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)~Placebo: tablet"
11076968|NCT01451931|BG000|Baseline|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
11076969|NCT01451931|BG001|Baseline|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
11076970|NCT01451931|BG002|Baseline|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
11076971|NCT01451931|BG003|Baseline|Total|Total of all reporting groups
11076972|NCT01451931|FG000|Participant Flow|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
11076973|NCT01451931|FG001|Participant Flow|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
11076974|NCT01451931|FG002|Participant Flow|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
11076975|NCT01451931|OG000|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
11076976|NCT01451931|OG001|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
11076977|NCT01451931|OG002|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
11076978|NCT01451931|OG000|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
11076979|NCT01451931|EG000|Reported Event|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
11076980|NCT01451931|EG001|Reported Event|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
11076981|NCT01451931|EG002|Reported Event|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
11076982|NCT01451983|BG000|Baseline|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
11076983|NCT01451983|BG001|Baseline|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
11076984|NCT01451983|BG002|Baseline|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
11076985|NCT01451983|BG003|Baseline|Siblings|Siblings of individuals with autism spectrum disorders.
11076986|NCT01451983|BG004|Baseline|Total|Total of all reporting groups
11076987|NCT01451983|FG000|Participant Flow|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
11076988|NCT01451983|FG001|Participant Flow|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
11076989|NCT01451983|FG002|Participant Flow|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
11076990|NCT01451983|FG003|Participant Flow|Siblings|Siblings of individuals with autism spectrum disorders.
11076991|NCT01451983|OG000|Outcome|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
11076992|NCT01451983|OG001|Outcome|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
11076993|NCT01451983|OG002|Outcome|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
11076994|NCT01451983|OG003|Outcome|Siblings|Siblings of individuals with autism spectrum disorders.
11076995|NCT01451983|EG000|Reported Event|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
11076996|NCT01451983|EG001|Reported Event|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
11076997|NCT01451983|EG002|Reported Event|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
11076998|NCT01451983|EG003|Reported Event|Siblings|Siblings of individuals with autism spectrum disorders.
11076999|NCT01451996|BG000|Baseline|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
11077000|NCT01451996|BG001|Baseline|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
11077001|NCT01451996|BG002|Baseline|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
11077002|NCT01451996|BG003|Baseline|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
11077003|NCT01451996|BG004|Baseline|Total|Total of all reporting groups
11077004|NCT01451996|FG000|Participant Flow|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
11077005|NCT01451996|FG001|Participant Flow|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
11077006|NCT01451996|FG002|Participant Flow|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
11077007|NCT01451996|FG003|Participant Flow|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
11077008|NCT01451996|OG000|Outcome|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
11077009|NCT01451996|OG001|Outcome|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
11077010|NCT01451996|OG002|Outcome|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
11077011|NCT01451996|OG003|Outcome|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
11077012|NCT01451996|EG000|Reported Event|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
11077013|NCT01451996|EG001|Reported Event|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
11077014|NCT01451996|EG002|Reported Event|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
11077015|NCT01451996|EG003|Reported Event|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
11077016|NCT01452126|BG000|Baseline|Ropivacaine|Each patient received ropivacaine-based nerve blockade at a fixed volume, with concentration determined per protocol
11077017|NCT01452126|FG000|Participant Flow|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
11077018|NCT01452126|OG000|Outcome|Femoral Nerve Block|Ropivacaine-based blockade of the femoral nerve, with concentration per protocol.
11077019|NCT01452126|OG001|Outcome|Supraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via a supraclavicular approach, with concentration per protocol.
11077020|NCT01452126|OG002|Outcome|Infraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via an infraclavicular approach, with concentration per protocol.
11077021|NCT01452126|OG003|Outcome|Popliteal Nerve Block|Ropivacaine-based blockade of the popliteal nerve, with concentration per protocol.
11077022|NCT01452126|OG000|Outcome|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
11077023|NCT01452126|EG000|Reported Event|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
11077024|NCT01452191|BG000|Baseline|Injury Prevention Briefing and Facilitation|Children's Centres will be given an Injury Prevention Briefing which offers guidance on best evidence on reducing fire related injuries in the home, a three hour staff training session and facilitation by the research team to support implementation of the IPB.
11077025|NCT01452191|BG001|Baseline|Injury Prevention Briefing Only|An Injury Prevention Briefing (IPB) , which offers guidance on best evidence on reducing fire related injuries in the home, will be posted to Children's centres.
10887663|NCT00502216|EG001|Reported Event|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
11077026|NCT01452191|BG002|Baseline|Usual Care|Children's centres undertake usual fire prevention activity.
11077027|NCT01452191|BG003|Baseline|Total|Total of all reporting groups
11077028|NCT01452191|FG000|Participant Flow|Injury Prevention Briefing and Facilitation|Children's Centres will be given an Injury Prevention Briefing which offers guidance on best evidence on reducing fire related injuries in the home, a three hour staff training session and facilitation by the research team to support implementation of the IPB.
11077029|NCT01452191|FG001|Participant Flow|Injury Prevention Briefing Only|An Injury Prevention Briefing (IPB) , which offers guidance on best evidence on reducing fire related injuries in the home, will be posted to Children's centres.
11077030|NCT01452191|FG002|Participant Flow|Usual Care|Children's centres undertake usual fire prevention activity.
11077031|NCT01452191|OG000|Outcome|Injury Prevention Briefing and Facilitation|Children's Centres will be given an Injury Prevention Briefing which offers guidance on best evidence on reducing fire related injuries in the home, a three hour staff training session and facilitation by the research team to support implementation of the IPB.
11077032|NCT01452191|OG001|Outcome|Injury Prevention Briefing Only|An Injury Prevention Briefing (IPB) , which offers guidance on best evidence on reducing fire related injuries in the home, will be posted to Children's centres.
11077033|NCT01452191|OG002|Outcome|Usual Care|Children's centres undertake usual fire prevention activity.
11077034|NCT01452191|EG000|Reported Event|Injury Prevention Briefing and Facilitation|Children's Centres will be given an Injury Prevention Briefing which offers guidance on best evidence on reducing fire related injuries in the home, a three hour staff training session and facilitation by the research team to support implementation of the IPB.
11077035|NCT01452191|EG001|Reported Event|Injury Prevention Briefing Only|An Injury Prevention Briefing (IPB) , which offers guidance on best evidence on reducing fire related injuries in the home, will be posted to Children's centres.
11077036|NCT01452191|EG002|Reported Event|Usual Care|Children's centres undertake usual fire prevention activity.
11150309|NCT01876992|FG001|Participant Flow|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
11077037|NCT01452269|BG000|Baseline|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
11077038|NCT01452269|BG001|Baseline|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
11077039|NCT01452269|BG002|Baseline|Total|Total of all reporting groups
11077040|NCT01452269|FG000|Participant Flow|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
11077041|NCT01452269|FG001|Participant Flow|Delayed Intervention Group|"This arm received the Group intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
11077042|NCT01452269|OG000|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
11077043|NCT01452269|OG001|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
11077044|NCT01452269|EG000|Reported Event|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
11173616|NCT02016612|FG001|Participant Flow|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11077045|NCT01452269|EG001|Reported Event|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
11077046|NCT01452347|BG000|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
11077047|NCT01452347|BG001|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
11077048|NCT01452347|BG002|Baseline|Total|Total of all reporting groups
11077049|NCT01452347|FG000|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
11077050|NCT01452347|FG001|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
11077051|NCT01452347|OG000|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the pharmacokinetic set (PKS) who have a corresponding predicted value.
11077052|NCT01452347|OG001|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
11077053|NCT01452347|OG000|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
11077054|NCT01452347|OG000|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
11077055|NCT01452347|EG000|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
11077056|NCT01452347|EG001|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
11077057|NCT01452412|BG000|Baseline|Sodium Bicarbonate|"0.4 mEq/kg/day ideal body weight to be taken once a day~Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day"
11077058|NCT01452412|BG001|Baseline|Placebo|"placebo dosage/frequency equivalent to sodium bicarbonate~Placebo: To be taken on the same schedule as the active arm"
11077059|NCT01452412|BG002|Baseline|Total|Total of all reporting groups
11077060|NCT01452412|FG000|Participant Flow|Sodium Bicarbonate|"0.4 mEq/kg/day ideal body weight to be taken once a day~Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day"
11077061|NCT01452412|FG001|Participant Flow|Placebo|"placebo dosage/frequency equivalent to sodium bicarbonate~Placebo: To be taken on the same schedule as the active arm"
11077062|NCT01452412|OG000|Outcome|Sodium Bicarbonate|"0.4 mEq/kg/day ideal body weight to be taken once a day~Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day"
11077063|NCT01452412|OG001|Outcome|Placebo|"placebo dosage/frequency equivalent to sodium bicarbonate~Placebo: To be taken on the same schedule as the active arm"
11077064|NCT01452412|EG000|Reported Event|Sodium Bicarbonate|"0.4 mEq/kg/day ideal body weight to be taken once a day~Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day"
11077065|NCT01452412|EG001|Reported Event|Placebo|"placebo dosage/frequency equivalent to sodium bicarbonate~Placebo: To be taken on the same schedule as the active arm"
11077066|NCT01452425|BG000|Baseline|Tourniquet|No adverse event
11077067|NCT01452425|FG000|Participant Flow|Tourniquet|"Inflation of a tourniquet~Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
11077068|NCT01452425|OG000|Outcome|Tourniquet|"Inflation of a tourniquet~Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
11077069|NCT01452425|OG000|Outcome|Tourniquet|
11077070|NCT01452425|EG000|Reported Event|Tourniquet|No adverse event
11077071|NCT01452529|BG000|Baseline|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11077072|NCT01452529|BG001|Baseline|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily"
11077073|NCT01452529|BG002|Baseline|Total|Total of all reporting groups
11077074|NCT01452529|FG000|Participant Flow|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects qualification for randomization
11077075|NCT01452529|FG001|Participant Flow|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11077076|NCT01452529|FG002|Participant Flow|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily"
11077077|NCT01452529|OG000|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11077078|NCT01452529|OG001|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily"
11077079|NCT01452529|EG000|Reported Event|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects' qualification for randomization
11077080|NCT01452529|EG001|Reported Event|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily"
11077081|NCT01452529|EG002|Reported Event|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily"
11077082|NCT01452789|BG000|Baseline|Sublingual Buprenorphine|sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
11077083|NCT01452789|BG001|Baseline|Oral Morphine|oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
11077084|NCT01452789|BG002|Baseline|Total|Total of all reporting groups
11077085|NCT01452789|FG000|Participant Flow|Sublingual Buprenorphine|sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
11077086|NCT01452789|FG001|Participant Flow|Oral Morphine|oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
11077087|NCT01452789|OG000|Outcome|Sublingual Buprenorphine|sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
11077088|NCT01452789|OG001|Outcome|Oral Morphine|oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
11077089|NCT01452789|EG000|Reported Event|Sublingual Buprenorphine|sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
11077090|NCT01452789|EG001|Reported Event|Oral Morphine|oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
11077091|NCT01452919|BG000|Baseline|All Participants|"40 milligram (mg) or 80 mg LY2140023 administered orally, twice daily for 4 weeks during open-label treatment period.~Placebo, or 40 mg or 80 mg LY2140023 administered orally, twice daily for 2 weeks during double-blind, randomized withdrawal treatment period."
11077092|NCT01452919|FG000|Participant Flow|LY2140023 (Open-Label )|40 milligram (mg) or 80 mg LY2140023 administered orally, twice daily for 4 weeks during open-label treatment period.
11077093|NCT01452919|FG001|Participant Flow|Placebo (Randomization)|Placebo administered orally, twice daily for 2 weeks during double-blind, randomized withdrawal treatment period.
11077094|NCT01452919|FG002|Participant Flow|LY2140023 (Randomization)|40 mg or 80 mg LY2140023 administered orally, twice daily for 2 weeks during double-blind, randomized withdrawal treatment period.
11077095|NCT01452919|OG000|Outcome|Placebo (Randomization)|Placebo administered orally, twice daily for 2 weeks during double-blind, randomized withdrawal treatment period.
11077096|NCT01452919|OG001|Outcome|LY2140023 (Randomization)|40 mg or 80 mg LY2140023 administered orally, twice daily for 2 weeks during double-blind, randomized withdrawal treatment period.
11077097|NCT01452919|OG000|Outcome|All Participants|40 milligram (mg) or 80 mg LY2140023 administered orally, twice daily for 4 weeks during open-label treatment period.
11077098|NCT01452919|OG000|Outcome|Placebo (Randomization)|Placebo administered orally, twice daily for 2 weeks during double-blind randomized withdrawal treatment period.
11077099|NCT01452919|OG001|Outcome|LY2140023 (Randomization)|40 mg or 80 mg LY2140023 administered orally, twice daily for 2 weeks during double-blind randomized withdrawal treatment period.
11077100|NCT01452919|EG000|Reported Event|LY2140023 (Open-Label )|40 milligram (mg) or 80 mg LY2140023 administered orally, twice daily for 4 weeks during open-label treatment period.
11077101|NCT01452919|EG001|Reported Event|Placebo (Randomization)|Placebo administered orally, twice daily for 2 weeks during double-blind randomized withdrawal treatment period.
11077102|NCT01452919|EG002|Reported Event|LY2140023 (Randomization)|40 mg or 80 mg LY2140023 administered orally, twice daily for 2 weeks during double-blind randomized withdrawal treatment period.
11077103|NCT01453023|BG000|Baseline|FF 100 µg/VI 25 µg and FF 100 µg in TPs 1 and 2|All participants who received FF 100 µg/VI 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2 or FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
11077104|NCT01453023|FG000|Participant Flow|FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2|Participants received fluticasone furoate (FF) 100 micrograms (µg)/Vilanterol (VI) 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
11077105|NCT01453023|FG001|Participant Flow|FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2|Participants received FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
11077106|NCT01453023|OG000|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077107|NCT01453023|OG001|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077108|NCT01453023|EG000|Reported Event|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077109|NCT01453023|EG001|Reported Event|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077110|NCT01453036|BG000|Baseline|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
11077111|NCT01453036|BG001|Baseline|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
11077112|NCT01453036|BG002|Baseline|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
11077113|NCT01453036|BG003|Baseline|Total|Total of all reporting groups
11077114|NCT01453036|FG000|Participant Flow|Conventional AOC Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
11077115|NCT01453036|FG001|Participant Flow|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
11077116|NCT01453036|FG002|Participant Flow|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
11077117|NCT01453036|OG000|Outcome|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
11077118|NCT01453036|OG001|Outcome|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
11077119|NCT01453036|OG002|Outcome|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
11077120|NCT01453036|EG000|Reported Event|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
11077121|NCT01453036|EG001|Reported Event|Convential AOM Group|
11077122|NCT01453036|EG002|Reported Event|Mutation Test Group|
11077123|NCT01453049|BG000|Baseline|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
11077124|NCT01453049|BG001|Baseline|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
11077125|NCT01453049|BG002|Baseline|Total|Total of all reporting groups
11077126|NCT01453049|FG000|Participant Flow|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
11077127|NCT01453049|FG001|Participant Flow|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
11077128|NCT01453049|OG000|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
11077129|NCT01453049|OG001|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
11077130|NCT01453049|EG000|Reported Event|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
11077131|NCT01453049|EG001|Reported Event|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
11077132|NCT01453075|BG000|Baseline|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
11077133|NCT01453075|BG001|Baseline|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
11077134|NCT01453075|BG002|Baseline|Total|Total of all reporting groups
11077135|NCT01453075|FG000|Participant Flow|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
11077136|NCT01453075|FG001|Participant Flow|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
11077137|NCT01453075|OG000|Outcome|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
11077138|NCT01453075|OG001|Outcome|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
11077139|NCT01453075|EG000|Reported Event|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
11077140|NCT01453075|EG001|Reported Event|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
11077141|NCT01453153|BG000|Baseline|PEGPH20 1.0 μg/kg|Participants received PEGylated Recombinant Human Hyaluronidase PH20 (PEGPH20) 1.0 micrograms per kilogram (μg/kg). PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 milligrams per meters squared (mg/m^2) administered via intravenous (IV) infusion. Before the Recommend Phase 2 Dose (RP2D) was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077142|NCT01453153|BG001|Baseline|PEGPH20 1.6 μg/kg|Participants received PEGPH20 1.6 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077143|NCT01453153|BG002|Baseline|PEGPH20 3.0 μg/kg|Participants received PEGPH20 3.0 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077144|NCT01453153|BG003|Baseline|Total|Total of all reporting groups
11077145|NCT01453153|FG000|Participant Flow|PEGPH20 1.0 μg/kg|Participants received PEGylated Recombinant Human Hyaluronidase PH20 (PEGPH20) 1.0 micrograms per kilogram (μg/kg). PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 milligrams per meters squared (mg/m^2) administered via intravenous (IV) infusion. Before the Recommend Phase 2 Dose (RP2D) was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077146|NCT01453153|FG001|Participant Flow|PEGPH20 1.6 μg/kg|Participants received PEGPH20 1.6 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077147|NCT01453153|FG002|Participant Flow|PEGPH20 3.0 μg/kg|Participants received PEGPH20 3.0 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077148|NCT01453153|OG000|Outcome|PEGPH20 1.0 μg/kg|Participants received PEGylated Recombinant Human Hyaluronidase PH20 (PEGPH20) 1.0 micrograms per kilogram (μg/kg). PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 milligrams per meters squared (mg/m^2) administered via intravenous (IV) infusion. Before the Recommend Phase 2 Dose (RP2D) was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077149|NCT01453153|OG001|Outcome|PEGPH20 1.6 μg/kg|Participants received PEGPH20 1.6 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077150|NCT01453153|OG002|Outcome|PEGPH20 3.0 μg/kg|Participants received PEGPH20 3.0 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077151|NCT01453153|OG000|Outcome|PEGPH20 Plus Gemcitabine|Participants received PEGPH20 1.0, 1.6, and 3.0 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. Participants received dexamethasone 4 or 8 mg orally, via intramuscular injection, or via IV injection. Dexamethasone (4 to 8 mg) was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077152|NCT01453153|OG000|Outcome|PEGPH20 1.0, 1.6, or 3.0 μg/kg|Participants received PEGylated Recombinant Human Hyaluronidase PH20 (PEGPH20) 1.0, 1.6, or 3.0 micrograms per kilogram (μg/kg). PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 milligrams per meters squared (mg/m^2) administered via intravenous (IV) infusion. Before the Recommend Phase 2 Dose (RP2D) was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077153|NCT01453153|OG000|Outcome|Responders|Participants received PEGylated Recombinant Human Hyaluronidase PH20 (PEGPH20) 1.0, 1.6, or 3.0 micrograms per kilogram (μg/kg). PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 milligrams per meters squared (mg/m^2) administered via intravenous (IV) infusion. Before the Recommend Phase 2 Dose (RP2D) was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077154|NCT01453153|OG001|Outcome|Non-responders|Participants received PEGPH20 1.0, 1.6, or 3.0 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11173617|NCT02016612|FG002|Participant Flow|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11077155|NCT01453153|EG000|Reported Event|PEGPH20 1.0 μg/kg|Participants received PEGylated Recombinant Human Hyaluronidase PH20 (PEGPH20) 1.0 micrograms per kilogram (μg/kg). PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 milligrams per meters squared (mg/m^2) administered via intravenous (IV) infusion. Before the Recommend Phase 2 Dose (RP2D) was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077156|NCT01453153|EG001|Reported Event|PEGPH20 1.6 μg/kg|Participants received PEGPH20 1.6 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077157|NCT01453153|EG002|Reported Event|PEGPH20 3.0 μg/kg|Participants received PEGPH20 3.0 μg/kg. PEGPH20 was administered twice weekly for 4 consecutive weeks and then once weekly for the next 3 weeks during Cycle 1. For each cycle thereafter, PEGPH20 was administered once weekly for 3 consecutive weeks. Participants received gemcitabine 1000 mg/m^2 administered via IV infusion. Before the RP2D was established, gemcitabine was administered 2 hours after the second dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and on the same day as PEGPH20 during each week thereafter. After the RP2D was established, gemcitabine was administered within 24 hours after the first dose of PEGPH20 during Weeks 1 to 4 of Cycle 1 and 2 to 24 hours after each PEGPH20 dose thereafter. Dexamethasone was administered approximately 1 hour prior to and 8 to 12 hours after PEGPH20 dosing.
11077158|NCT01453166|BG000|Baseline|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
11077159|NCT01453166|BG001|Baseline|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
11077160|NCT01453166|BG002|Baseline|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
11077161|NCT01453166|BG003|Baseline|Total|Total of all reporting groups
11077162|NCT01453166|FG000|Participant Flow|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
11077163|NCT01453166|FG001|Participant Flow|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
11077164|NCT01453166|FG002|Participant Flow|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
11077165|NCT01453166|OG000|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
11077166|NCT01453166|OG001|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
11077167|NCT01453166|OG002|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
11077168|NCT01453166|EG000|Reported Event|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
11077169|NCT01453166|EG001|Reported Event|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
11077170|NCT01453166|EG002|Reported Event|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
11077171|NCT01453205|BG000|Baseline|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077172|NCT01453205|BG001|Baseline|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077173|NCT01453205|BG002|Baseline|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077174|NCT01453205|BG003|Baseline|TOTAL|Total of all reporting groups
11077175|NCT01453205|FG000|Participant Flow|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11150310|NCT01876992|OG000|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.~Metformin"
11077176|NCT01453205|FG001|Participant Flow|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077177|NCT01453205|FG002|Participant Flow|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077178|NCT01453205|OG000|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077179|NCT01453205|OG001|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077180|NCT01453205|OG002|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077181|NCT01453205|OG000|Outcome|MEDI-551|Participants were received MEDI-551 2 mg/kg or 4 mg/kg by IV infusion. Recommended MEDI-551 dose was selected based on the DMC reviews.
11077182|NCT01453205|OG000|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077183|NCT01453205|OG001|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11173618|NCT02016612|FG003|Participant Flow|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
10849886|NCT00299104|EG001|Reported Event|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
11077184|NCT01453205|EG000|Reported Event|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077185|NCT01453205|EG001|Reported Event|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077186|NCT01453205|EG002|Reported Event|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
11077187|NCT01453296|BG000|Baseline|VI 25 µg/Placebo or Placebo/VI 25 µg|Participants received either vilanterol (VI) 25 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by a repeat dose of the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled VI 25 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077188|NCT01453296|FG000|Participant Flow|Sequence 1: VI 25 µg Followed by Placebo|Participants received vilanterol (VI) 25 micrograms (µg) and matching placebo in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via ae Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
11077189|NCT01453296|FG001|Participant Flow|Sequence 2: Placebo Followed by VI 25 µg|Participants received placebo and VI 25 µg in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
11077190|NCT01453296|OG000|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077191|NCT01453296|OG001|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077192|NCT01453296|EG000|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077193|NCT01453296|EG001|Reported Event|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
11077194|NCT01453348|BG000|Baseline|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
11077195|NCT01453348|BG001|Baseline|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
11077196|NCT01453348|BG002|Baseline|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
11077197|NCT01453348|BG003|Baseline|Total|Total of all reporting groups
11077198|NCT01453348|FG000|Participant Flow|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
11077199|NCT01453348|FG001|Participant Flow|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
11077200|NCT01453348|FG002|Participant Flow|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
11077201|NCT01453348|OG000|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
11077202|NCT01453348|OG001|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
11077203|NCT01453348|OG001|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
11077204|NCT01453348|OG000|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
11077205|NCT01453348|OG001|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
11077206|NCT01453348|OG002|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
11077207|NCT01453348|EG000|Reported Event|HepA/B|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
11077208|NCT01453348|EG001|Reported Event|HepA/B+ACWY|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
11077209|NCT01453348|EG002|Reported Event|ACWY|Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
11077210|NCT01453361|BG000|Baseline|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
11077211|NCT01453361|FG000|Participant Flow|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
11077212|NCT01453361|OG000|Outcome|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
11077213|NCT01453361|EG000|Reported Event|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
11077214|NCT01453374|BG000|Baseline|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
11077215|NCT01453374|FG000|Participant Flow|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
11077216|NCT01453374|OG000|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
11077217|NCT01453374|OG001|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
11077218|NCT01453374|OG000|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
11077219|NCT01453374|EG000|Reported Event|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
11077220|NCT01453387|BG000|Baseline|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
11077221|NCT01453387|BG001|Baseline|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
11077222|NCT01453387|BG002|Baseline|Total|Total of all reporting groups
11077223|NCT01453387|FG000|Participant Flow|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
11077224|NCT01453387|FG001|Participant Flow|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
11077225|NCT01453387|OG000|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
11077226|NCT01453387|OG001|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
11077227|NCT01453387|OG000|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
11077228|NCT01453387|OG000|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077229|NCT01453387|OG001|Outcome|Part 1 - MSC2015103B (Schedule 2)|The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
11077230|NCT01453387|OG000|Outcome|Part 1 - MSC2015103B (Schedule 1)|The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077231|NCT01453387|OG000|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077232|NCT01453387|OG001|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077233|NCT01453387|OG002|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077234|NCT01453387|OG003|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077235|NCT01453387|OG004|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077236|NCT01453387|OG005|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077237|NCT01453387|OG006|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
11077238|NCT01453387|OG007|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
11077239|NCT01453387|OG008|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
11077240|NCT01453387|OG008|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
11077241|NCT01453387|OG007|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
11077242|NCT01453387|OG000|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
11077243|NCT01453387|OG001|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
11077244|NCT01453387|EG000|Reported Event|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
11077245|NCT01453387|EG001|Reported Event|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
11077246|NCT01453413|BG000|Baseline|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
11077247|NCT01453413|FG000|Participant Flow|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
11077248|NCT01453413|OG000|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
11077249|NCT01453413|EG000|Reported Event|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
11077250|NCT01453439|BG000|Baseline|Cognitive Behavior Therapy (CBT)|Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD.
11077251|NCT01453439|BG001|Baseline|Supportive Psychotherapy (SPT)|SPT is a widely received psychosocial treatment by persons with BDD.
11077252|NCT01453439|BG002|Baseline|Total|Total of all reporting groups
11077253|NCT01453439|FG000|Participant Flow|Cognitive Behavior Therapy (CBT)|Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD.
11077254|NCT01453439|FG001|Participant Flow|Supportive Psychotherapy (SPT)|SPT is a widely received psychosocial treatment by persons with BDD.
11077255|NCT01453439|OG000|Outcome|Cognitive Behavior Therapy (CBT)|Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
11077256|NCT01453439|OG001|Outcome|Supportive Psychotherapy (SPT)|SPT is the most common psychosocial treatment received by persons with BDD.
11077257|NCT01453439|EG000|Reported Event|Cognitive Behavior Therapy (CBT)|Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD.
11077258|NCT01453439|EG001|Reported Event|Supportive Psychotherapy (SPT)|SPT is a widely received psychosocial treatment by persons with BDD.
11077259|NCT01453569|BG000|Baseline|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
11077260|NCT01453569|BG001|Baseline|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
11077261|NCT01453569|BG002|Baseline|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
11077262|NCT01453569|BG003|Baseline|Total|Total of all reporting groups
11077263|NCT01453569|FG000|Participant Flow|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
11077264|NCT01453569|FG001|Participant Flow|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
11077265|NCT01453569|FG002|Participant Flow|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
11077266|NCT01453569|OG000|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
11077267|NCT01453569|OG001|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
11077268|NCT01453569|OG002|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
11077269|NCT01453569|EG000|Reported Event|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
11077270|NCT01453569|EG001|Reported Event|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
11077271|NCT01453569|EG002|Reported Event|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
11077272|NCT01453595|BG000|Baseline|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
11077273|NCT01453595|BG001|Baseline|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
11077274|NCT01453595|BG002|Baseline|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
11077275|NCT01453595|BG003|Baseline|Total|Total of all reporting groups
11077276|NCT01453595|FG000|Participant Flow|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
11077277|NCT01453595|FG001|Participant Flow|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
11077278|NCT01453595|FG002|Participant Flow|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
11077279|NCT01453595|OG000|Outcome|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
11077280|NCT01453595|EG000|Reported Event|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
11077281|NCT01453595|EG001|Reported Event|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
11077282|NCT01453595|EG002|Reported Event|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
11077283|NCT01453725|BG000|Baseline|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
11077284|NCT01453725|BG001|Baseline|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
11077285|NCT01453725|BG002|Baseline|Total|Total of all reporting groups
11077286|NCT01453725|FG000|Participant Flow|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
11077287|NCT01453725|FG001|Participant Flow|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
11077288|NCT01453725|OG000|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
11077289|NCT01453725|OG001|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
11077290|NCT01453725|EG000|Reported Event|Part 1: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
11077291|NCT01453725|EG001|Reported Event|Part 1: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
11077292|NCT01453725|EG002|Reported Event|Part 2: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
11077293|NCT01453725|EG003|Reported Event|Part 2: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
11077294|NCT01453855|BG000|Baseline|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
11077295|NCT01453855|BG001|Baseline|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
11077296|NCT01453855|BG002|Baseline|Total|Total of all reporting groups
11077297|NCT01453855|FG000|Participant Flow|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
11077298|NCT01453855|FG001|Participant Flow|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
11077299|NCT01453855|OG000|Outcome|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
11077300|NCT01453855|OG001|Outcome|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
11077301|NCT01453855|EG000|Reported Event|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
11077302|NCT01453855|EG001|Reported Event|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
11077303|NCT01453894|BG000|Baseline|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
11077304|NCT01453894|BG001|Baseline|Usual Care Control Group|Patients assigned to this arm will receive usual care.
11077305|NCT01453894|BG002|Baseline|Total|Total of all reporting groups
11150311|NCT01876992|OG001|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
11077306|NCT01453894|FG000|Participant Flow|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
11077307|NCT01453894|FG001|Participant Flow|Usual Care Control Group|Patients assigned to this arm will receive usual care.
11077308|NCT01453894|OG000|Outcome|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
11077309|NCT01453894|OG001|Outcome|Usual Care Control Group|Patients assigned to this arm will receive usual care.
11077310|NCT01453894|EG000|Reported Event|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
11077311|NCT01453894|EG001|Reported Event|Usual Care Control Group|Patients assigned to this arm will receive usual care.
11077312|NCT01453998|BG000|Baseline|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077313|NCT01453998|BG001|Baseline|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077314|NCT01453998|BG002|Baseline|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077315|NCT01453998|BG003|Baseline|Total|Total of all reporting groups
11077316|NCT01453998|FG000|Participant Flow|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077317|NCT01453998|FG001|Participant Flow|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077318|NCT01453998|FG002|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077319|NCT01453998|OG000|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077320|NCT01453998|OG001|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077321|NCT01453998|OG002|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077322|NCT01453998|EG000|Reported Event|GSK217744 Group 1(Before Protocol Amendment2)|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077323|NCT01453998|EG001|Reported Event|GSK217744 Group 2(Before Protocol Amendment2)|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077324|NCT01453998|EG002|Reported Event|Infanrix Hexa Group(Before Protocol Amendment2)|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077325|NCT01453998|EG003|Reported Event|GSK217744 Group 1(After Protocol Amendment2)|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077326|NCT01453998|EG004|Reported Event|GSK217744 Group 2(After Protocol Amendment2)|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
11077327|NCT01453998|EG005|Reported Event|Infanrix Hexa Group(After Protocol Amendment2)|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively
11077328|NCT01454063|BG000|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11077329|NCT01454063|BG001|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11077330|NCT01454063|BG002|Baseline|Total|Total of all reporting groups
11077331|NCT01454063|FG000|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11077332|NCT01454063|FG001|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11077333|NCT01454063|OG000|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11173619|NCT02016612|OG000|Outcome|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11077334|NCT01454063|OG001|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11077335|NCT01454063|EG000|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11077336|NCT01454063|EG001|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
11077337|NCT01454076|BG000|Baseline|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077338|NCT01454076|BG001|Baseline|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077339|NCT01454076|BG002|Baseline|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077340|NCT01454076|BG003|Baseline|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077341|NCT01454076|BG004|Baseline|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077342|NCT01454076|BG005|Baseline|Total|Total of all reporting groups
11077343|NCT01454076|FG000|Participant Flow|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077344|NCT01454076|FG001|Participant Flow|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077345|NCT01454076|FG002|Participant Flow|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077346|NCT01454076|FG003|Participant Flow|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077347|NCT01454076|FG004|Participant Flow|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077348|NCT01454076|OG000|Outcome|Arm 1: Ixazomib 2.5 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
11077349|NCT01454076|OG001|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
11077350|NCT01454076|OG002|Outcome|Arm 2: Ixazomib 4 mg Capsule A|Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
11233728|NCT02430870|OG001|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11077351|NCT01454076|OG003|Outcome|Arm 2: Ixazomib 4 mg Capsule B|Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
11077352|NCT01454076|OG004|Outcome|Arm 3: Ixazomib 4 mg Fasted|Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
11077353|NCT01454076|OG005|Outcome|Arm 3: Ixazomib 4 mg Fed|Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
11077354|NCT01454076|OG006|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
11077355|NCT01454076|OG007|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
11077356|NCT01454076|OG000|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077357|NCT01454076|OG001|Outcome|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077358|NCT01454076|OG002|Outcome|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077359|NCT01454076|OG003|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). Participant received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077360|NCT01454076|OG004|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
11077361|NCT01454076|OG003|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11173620|NCT02016612|OG001|Outcome|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173621|NCT02016612|OG002|Outcome|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173622|NCT02016612|OG003|Outcome|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173623|NCT02016612|EG000|Reported Event|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173624|NCT02016612|EG001|Reported Event|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173625|NCT02016612|EG002|Reported Event|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173626|NCT02016612|EG003|Reported Event|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
11173627|NCT02016625|BG000|Baseline|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
11077362|NCT01454076|EG000|Reported Event|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077363|NCT01454076|EG001|Reported Event|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077364|NCT01454076|EG002|Reported Event|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077365|NCT01454076|EG003|Reported Event|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077366|NCT01454076|EG004|Reported Event|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
11077367|NCT01454102|BG000|Baseline|Arm A: Nivolumab + Gemcitabine + Cisplatin|Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077368|NCT01454102|BG001|Baseline|Arm B: Nivolumab + Pemetrexed + Cisplatin|Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077369|NCT01454102|BG002|Baseline|Arm C10: Nivolumab + Paclitaxel + Carboplatin|Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077370|NCT01454102|BG003|Baseline|Arm D: Nivolumab + Bevacizumab Maintenance|NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression
11077371|NCT01454102|BG004|Baseline|Arm E: Nivolumab + Erlotinib|Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression
11077372|NCT01454102|BG005|Baseline|Arm F: Nivolumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression
11077373|NCT01454102|BG006|Baseline|Arm GH: Nivolumab + Ipilimumab|Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077374|NCT01454102|BG007|Baseline|Arm IJ: Nivolumab + Ipilimumab|Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077375|NCT01454102|BG008|Baseline|Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)|SQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
11077376|NCT01454102|BG009|Baseline|Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)|NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
11077377|NCT01454102|BG010|Baseline|Arm M: Nivolumab|Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression
11077378|NCT01454102|BG011|Baseline|Arm N: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077379|NCT01454102|BG012|Baseline|Arm O: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
11077380|NCT01454102|BG013|Baseline|Arm P: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity
11077381|NCT01454102|BG014|Baseline|Arm Q: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
11077382|NCT01454102|BG015|Baseline|Arm C5: Nivolumab + Paclitaxel + Carboplatin|Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4
11077383|NCT01454102|BG016|Baseline|Total|Total of all reporting groups
11077384|NCT01454102|FG000|Participant Flow|Arm A: Nivolumab + Gemcitabine + Cisplatin|Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077385|NCT01454102|FG001|Participant Flow|Arm B: Nivolumab + Pemetrexed + Cisplatin|Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077386|NCT01454102|FG002|Participant Flow|Arm C10: Nivolumab + Paclitaxel + Carboplatin|Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077387|NCT01454102|FG003|Participant Flow|Arm D: Nivolumab + Bevacizumab Maintenance|NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression
11077388|NCT01454102|FG004|Participant Flow|Arm E: Nivolumab + Erlotinib|Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression
11077389|NCT01454102|FG005|Participant Flow|Arm F: Nivolumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression
11077390|NCT01454102|FG006|Participant Flow|Arm GH: Nivolumab + Ipilimumab|Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077391|NCT01454102|FG007|Participant Flow|Arm IJ: Nivolumab + Ipilimumab|Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077392|NCT01454102|FG008|Participant Flow|Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)|SQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
11077393|NCT01454102|FG009|Participant Flow|Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)|NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
11077394|NCT01454102|FG010|Participant Flow|Arm M: Nivolumab|Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression
11077395|NCT01454102|FG011|Participant Flow|Arm N: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077396|NCT01454102|FG012|Participant Flow|Arm O: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
11077397|NCT01454102|FG013|Participant Flow|Arm P: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity
11077398|NCT01454102|FG014|Participant Flow|Arm Q: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
11077399|NCT01454102|FG015|Participant Flow|Arm C5: Nivolumab + Paclitaxel + Carboplatin|Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4
11077400|NCT01454102|OG000|Outcome|Arm A: Nivolumab + Gemcitabine + Cisplatin|Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077401|NCT01454102|OG001|Outcome|Arm B: Nivolumab + Pemetrexed + Cisplatin|Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077402|NCT01454102|OG002|Outcome|Arm C10: Nivolumab + Paclitaxel + Carboplatin|Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077403|NCT01454102|OG003|Outcome|Arm D: Nivolumab + Bevacizumab Maintenance|NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression
11077404|NCT01454102|OG004|Outcome|Arm E: Nivolumab + Erlotinib|Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression
11077405|NCT01454102|OG005|Outcome|Arm F: Nivolumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression
11077406|NCT01454102|OG006|Outcome|Arm GH: Nivolumab + Ipilimumab|Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077407|NCT01454102|OG007|Outcome|Arm IJ: Nivolumab + Ipilimumab|Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077408|NCT01454102|OG008|Outcome|Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)|SQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
11077409|NCT01454102|OG009|Outcome|Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)|NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
11077410|NCT01454102|OG010|Outcome|Arm M: Nivolumab|Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression
11077411|NCT01454102|OG011|Outcome|Arm N: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077412|NCT01454102|OG012|Outcome|Arm O: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
11077413|NCT01454102|OG013|Outcome|Arm P: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity
11077414|NCT01454102|OG014|Outcome|Arm Q: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
11077415|NCT01454102|OG015|Outcome|Arm C5: Nivolumab + Paclitaxel + Carboplatin|Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4
11077416|NCT01454102|EG000|Reported Event|Arm A: Nivolumab + Gemcitabine + Cisplatin|Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077417|NCT01454102|EG001|Reported Event|Arm J: Nivolumab + Ipilimumab|Chemotherapy-naive NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077418|NCT01454102|EG002|Reported Event|Arm K: Nivolumab In Squamous Histology Subjects (NSCLC)|SQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
11077419|NCT01454102|EG003|Reported Event|Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC)|NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
11077420|NCT01454102|EG004|Reported Event|Arm M: Nivolumab|Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression
11077421|NCT01454102|EG005|Reported Event|Arm N: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077422|NCT01454102|EG006|Reported Event|Arm O: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
11077423|NCT01454102|EG007|Reported Event|Arm P: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity
11077424|NCT01454102|EG008|Reported Event|Arm Q: Nivolumab + Ipilimumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
11077425|NCT01454102|EG009|Reported Event|Arm B: Nivolumab + Pemetrexed + Cisplatin|Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077426|NCT01454102|EG010|Reported Event|Arm C: Nivolumab + Paclitaxel + Carboplatin|Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
11077427|NCT01454102|EG011|Reported Event|Arm D: Nivolumab + Bevacizumab Maintenance|NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression
11077428|NCT01454102|EG012|Reported Event|Arm E: Nivolumab + Erlotinib|Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression
11077429|NCT01454102|EG013|Reported Event|Arm F: Nivolumab|Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression
11077430|NCT01454102|EG014|Reported Event|Arm G: Nivolumab + Ipilimumab|Chemotherapy-naive SQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077431|NCT01454102|EG015|Reported Event|Arm H: Nivolumab + Ipilimumab|Chemotherapy-naive NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077432|NCT01454102|EG016|Reported Event|Arm I: Nivolumab + Ipilimumab|Chemotherapy-naive SQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
11077433|NCT01454258|BG000|Baseline|Cohort|Surgical patients from 10 hospitals over a period of 13 months
11077434|NCT01454258|FG000|Participant Flow|Cohort|Surgical patients from 10 hospitals over a period of 13 months
11077435|NCT01454258|OG000|Outcome|Crystalloids|crystalloids
11077436|NCT01454258|OG001|Outcome|Hydroxyethyl Starch|HES
11077437|NCT01454258|OG002|Outcome|Other Colloids|gelatine, albumin,
11077438|NCT01454258|EG000|Reported Event|Cohort|Surgical patients
11077439|NCT01454284|BG000|Baseline|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
11077440|NCT01454284|BG001|Baseline|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
11077441|NCT01454284|BG002|Baseline|Total|Total of all reporting groups
11077442|NCT01454284|FG000|Participant Flow|LY2605541 + Insulin Lispro|"Includes participants randomized to receive LY2605541 plus Insulin Lispro.~Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
11077443|NCT01454284|FG001|Participant Flow|Insulin Glargine + Insulin Lispro|"Includes participants randomized to receive Insulin Glargine plus Insulin Lispro.~Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
11077444|NCT01454284|OG000|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
11077445|NCT01454284|OG001|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
11077446|NCT01454284|EG000|Reported Event|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
11077447|NCT01454284|EG001|Reported Event|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
11077448|NCT01454362|BG000|Baseline|Electronic Cigarette First, Then Nicotine Inhalator|"Randomised to receive electronic cigarette at the first session. Tested at study session then given to use ad-lib over 24 hours. Participants then returned to the clinic.~1 week wash out period.~Asked to return to clinic to receive Nicotine Inhalator. Tested at clinic then given product to use ad-lib over 24 hours. Participants then returned to the clinic."
11077449|NCT01454362|BG001|Baseline|Nicotine Inhalator First, Then Electronic Cigarette|"Randomised to receive Nicotine Inhalator at the first session. Tested at study session then given to use ad-lib over 24 hours. Participants then returned to the clinic.~1 week wash out period.~Asked to return to clinic to receive electronic cigarette. Tested at clinic then given product to use ad-lib over 24 hours. Participants then returned to the clinic."
11077450|NCT01454362|BG002|Baseline|Total|Total of all reporting groups
11077451|NCT01454362|FG000|Participant Flow|Electronic Cigarette Then, Nicotine Inhalator|"Randomised to receive electronic cigarette at the first session. Tested at study session then given to use ad-lib over 24 hours. Participants then returned to the clinic.~1 week wash out period.~Asked to return to clinic to receive Nicotine Inhalator. Tested at clinic then given product to use ad-lib over 24 hours. Participants then returned to the clinic.~Nicotine: Inhalation of nicotine."
11227410|NCT02382913|EG008|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11077452|NCT01454362|FG001|Participant Flow|Nicotine Inhalator Then, Electronic Cigarette|"Randomised to receive Nicotine Inhalator at the first session. Tested at study session then given to use ad-lib over 24 hours. Participants then returned to the clinic.~1 week wash out period.~Asked to return to clinic to receive electronic cigarette. Tested at clinic then given product to use ad-lib over 24 hours. Participants then returned to the clinic."
11077453|NCT01454362|OG000|Outcome|Electronic Cigarette|All study participants.
11077454|NCT01454362|OG001|Outcome|Nicotine Inhalator|All study participants.
11077455|NCT01454362|OG000|Outcome|Electronic Cigarette|"All study participants.~We analysed 15 brands of the most popular E-Cs in the UK, EU and US for nicotine levels in the mist. Vapours were generated from cartridges of various nicotine content using a standard single-port linear smoking machine with a puff volume of 70 ml, 1 puff every 7 sec., and a puff duration of 1.8 sec (based on averaged puffing conditions from 10 E-C users found during preliminary studies). Nicotine was absorbed in two sequential washing bottles with methanol and internal standards and analysed with gas chromatography. One brand was selected for this study as it consistently delivers about 1mg of nicotine with 20 puffs.~Nicotine: Inhalation of nicotine."
11077456|NCT01454362|OG001|Outcome|Nicotine Inhalator|"All study participants.~The inhalator consists of a nicotine cartridge which is placed into a plastic mouthpiece. One cartridge contains 10mg of nicotine of which 4mg of nicotine can be extracted. Nicotine is delivered mainly through the oral cavity, throat, and upper respiratory tract with a minor fraction reaching the lungs. A single cartridge can be used for one 20-minute period of continuous puffing or periodic use of up to 400 puffs per cartridge.~Nicotine: Inhalation of nicotine."
11077457|NCT01454362|EG000|Reported Event|Electronic Cigarette|All study participants used product.
11077458|NCT01454362|EG001|Reported Event|Nicotine Inhalator|All study participants used product.
11077459|NCT01454401|BG000|Baseline|LeucoPatch Treatment of Diabetic Foot Ulcers|"Weekly treatment~LeucoPatch device: weekly treatment"
11077460|NCT01454401|FG000|Participant Flow|LeucoPatch Treatment of Diabetic Foot Ulcers|Weekly LeucoPatch treatment of diabetic foot ulcers
11077461|NCT01454401|OG000|Outcome|LeucoPatch|LeucoPatch: weekly treatment
11077462|NCT01454401|EG000|Reported Event|All Patients Consenting to be Enrolled in the Study.|"60 patients were included for a 2 week run-in period. If ulcer area decreased more than 40% during that time the ulcer were deemed healing and NOT included for treatment. 16 patients were excluded during the run-in period - 44 were treated. For safety analysis all patients were included"
11077463|NCT01454414|BG000|Baseline|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
11077464|NCT01454414|BG001|Baseline|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
11077465|NCT01454414|BG002|Baseline|Total|Total of all reporting groups
11077466|NCT01454414|FG000|Participant Flow|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
11077467|NCT01454414|FG001|Participant Flow|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
11077468|NCT01454414|OG000|Outcome|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
11077469|NCT01454414|OG001|Outcome|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
11077470|NCT01454414|EG000|Reported Event|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
11077471|NCT01454414|EG001|Reported Event|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
11077472|NCT01454505|BG000|Baseline|Stage A/Healthy Volunteers|AL-53817 nasal spray solution in 1 of 3 concentration doses, 1 or 2 sprays per nostril, OR Vehicle, 1 spray per nostril
11077473|NCT01454505|BG001|Baseline|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
11077474|NCT01454505|BG002|Baseline|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
11077475|NCT01454505|BG003|Baseline|Total|Total of all reporting groups
11077476|NCT01454505|FG000|Participant Flow|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
11077477|NCT01454505|FG001|Participant Flow|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
11077478|NCT01454505|FG002|Participant Flow|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
11077479|NCT01454505|FG003|Participant Flow|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
11077480|NCT01454505|OG000|Outcome|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
11077481|NCT01454505|OG001|Outcome|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
11077482|NCT01454505|OG000|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
11077483|NCT01454505|OG001|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
11077484|NCT01454505|EG000|Reported Event|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
11077485|NCT01454505|EG001|Reported Event|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
11077486|NCT01454505|EG002|Reported Event|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
11227411|NCT02382913|EG009|Reported Event|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
11227412|NCT02382939|BG000|Baseline|Norditropin|"Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:~IGF-I SDS > 3: dose reduction by 0.1 mg/day 2 < IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 < IGF-I SDS ≤ 2: No need of dose adjustment~2 < IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg)."
11227413|NCT02382939|BG001|Baseline|Somapacitan|"Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:~IGF-I SDS > 3: dose reduction by 1 mg 2 < IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 < IGF-I SDS ≤ 2: No need for dose adjustment~2 < IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg."
11077487|NCT01454505|EG003|Reported Event|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
11077488|NCT01454531|BG000|Baseline|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
11077489|NCT01454531|FG000|Participant Flow|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
11077490|NCT01454531|OG000|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
11077491|NCT01454531|EG000|Reported Event|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
11077492|NCT01454570|BG000|Baseline|Exoskeleton|Trained to use powered exoskeleton for overground ambulation
11077493|NCT01454570|FG000|Participant Flow|Exoskeleton|Participants trained to use powered exoskeleton for overground ambulation.
11077494|NCT01454570|OG000|Outcome|Exoskeleton|Trained to use powered exoskeleton for overground ambulation
11077495|NCT01454570|EG000|Reported Event|Exoskeleton|Participants trained to use powered exoskeleton for overground ambulation.
11077496|NCT01454583|BG000|Baseline|Group A|Patients treated with Aliskiren (DRI)
11077497|NCT01454583|BG001|Baseline|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
11077498|NCT01454583|BG002|Baseline|Group C|Patients without any RAS inhibition (No-RAS-I)
11227414|NCT02382939|BG002|Baseline|Total|Total of all reporting groups
11227415|NCT02382939|FG000|Participant Flow|Norditropin|"Participants received subcutaneous (s.c.) injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on insulin-like growth factor-I standard deviation score (IGF-I SDS) values:~IGF-I SDS > 3: dose reduction by 0.1 mg/day 2 < IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 < IGF-I SDS ≤ 2: No need of dose adjustment~2 < IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg)."
11077499|NCT01454583|BG003|Baseline|Total|Total of all reporting groups
11077500|NCT01454583|FG000|Participant Flow|Aliskiren|Patients treated with Aliskiren (DRI) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
11077501|NCT01454583|FG001|Participant Flow|ACE-I/ARB|Patients treated with ACE-I or ARB (ARB/ACE-I) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
11077502|NCT01454583|FG002|Participant Flow|No RAS-inhibition|Patients treated with no RAS-inhibition drugs at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
11077503|NCT01454583|OG000|Outcome|Group A|Patients treated with Aliskiren (DRI)
11077504|NCT01454583|OG001|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
11077505|NCT01454583|OG002|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
11077506|NCT01454583|EG000|Reported Event|Group A|Patients treated with Aliskiren (DRI)
11077507|NCT01454583|EG001|Reported Event|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
11077508|NCT01454583|EG002|Reported Event|Group C|Patients without any RAS inhibition (No-RAS-I)
11077509|NCT01454596|BG000|Baseline|Group A (Steroids) - Cohort 1: 1x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077510|NCT01454596|BG001|Baseline|Group A (Steroids) - Cohort 2: 3x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077511|NCT01454596|BG002|Baseline|Group A (Steroids) - Cohort 3: 1x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077512|NCT01454596|BG003|Baseline|Group B (No Steroids) - Cohort 1: 1x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077513|NCT01454596|BG004|Baseline|Group B (No Steroids) - Cohort 2: 3x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077514|NCT01454596|BG005|Baseline|Group B (No Steroids) - Cohort 3: 1x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077515|NCT01454596|BG006|Baseline|Group B (No Steroids) - Cohort 4: 3x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077516|NCT01454596|BG007|Baseline|Group B (No Steroids) - Cohort 5: 1x10(9)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077517|NCT01454596|BG008|Baseline|Combined Steroids/no Steroids) - Cohort 6: 3x10(9)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077518|NCT01454596|BG009|Baseline|Combined Steroids/no Steroids) - Cohort 7: 1x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077519|NCT01454596|BG010|Baseline|Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077520|NCT01454596|BG011|Baseline|Combined Steroids/no Steroids) - Cohort 9: 3x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.~Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077521|NCT01454596|BG012|Baseline|Total|Total of all reporting groups
11077522|NCT01454596|FG000|Participant Flow|Group A (Steroids) - Cohort 1: 1x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077523|NCT01454596|FG001|Participant Flow|Group A (Steroids) - Cohort 2: 3x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077524|NCT01454596|FG002|Participant Flow|Group A (Steroids) - Cohort 3: 1x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077525|NCT01454596|FG003|Participant Flow|Group B (No Steroids) - Cohort 1: 1x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077526|NCT01454596|FG004|Participant Flow|Group B (No Steroids) - Cohort 2: 3x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077527|NCT01454596|FG005|Participant Flow|Group B (No Steroids) - Cohort 3: 1x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077528|NCT01454596|FG006|Participant Flow|Group B (No Steroids) - Cohort 4: 3x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077529|NCT01454596|FG007|Participant Flow|Group B (No Steroids) - Cohort 5: 1x10(9)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077530|NCT01454596|FG008|Participant Flow|Combined Steroids/no Steroids) - Cohort 6: 3x10(9)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077531|NCT01454596|FG009|Participant Flow|Combined Steroids/no Steroids) - Cohort 7: 1x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077532|NCT01454596|FG010|Participant Flow|Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077533|NCT01454596|FG011|Participant Flow|Combined Steroids/no Steroids) - Cohort 9: 3x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated.~Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.~Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077534|NCT01454596|OG000|Outcome|Group A (Steroids) - Cohort 1: 1x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077535|NCT01454596|OG001|Outcome|Group A (Steroids) - Cohort 2: 3x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077536|NCT01454596|OG002|Outcome|Group A (Steroids) - Cohort 3: 1x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077537|NCT01454596|OG003|Outcome|Group B (No Steroids) - Cohort 1: 1x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077538|NCT01454596|OG004|Outcome|Group B (No Steroids) - Cohort 2: 3x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077539|NCT01454596|OG005|Outcome|Group B (No Steroids) - Cohort 3: 1x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077540|NCT01454596|OG006|Outcome|Group B (No Steroids) - Cohort 4: 3x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077541|NCT01454596|OG007|Outcome|Group B (No Steroids) - Cohort 5: 1x10(9)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077542|NCT01454596|OG008|Outcome|Combined Steroids/no Steroids) - Cohort 6: 3x10(9)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077543|NCT01454596|OG009|Outcome|Combined Steroids/no Steroids) - Cohort 7: 1x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077544|NCT01454596|OG010|Outcome|Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11173628|NCT02016625|BG001|Baseline|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
11173629|NCT02016625|BG002|Baseline|Total|Total of all reporting groups
11077545|NCT01454596|OG011|Outcome|Combined Steroids/no Steroids) - Cohort 9: 3x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.~Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077546|NCT01454596|EG000|Reported Event|Group A (Steroids) - Cohort 1: 1x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077547|NCT01454596|EG001|Reported Event|Group A (Steroids) - Cohort 2: 3x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077548|NCT01454596|EG002|Reported Event|Group A (Steroids) - Cohort 3: 1x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077549|NCT01454596|EG003|Reported Event|Group B (No Steroids) - Cohort 1: 1x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077550|NCT01454596|EG004|Reported Event|Group B (No Steroids) - Cohort 2: 3x10(7)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077551|NCT01454596|EG005|Reported Event|Group B (No Steroids) - Cohort 3: 1x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077552|NCT01454596|EG006|Reported Event|Group B (No Steroids) - Cohort 4: 3x10(8)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077553|NCT01454596|EG007|Reported Event|Group B (No Steroids) - Cohort 5: 1x10(9)|"Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077554|NCT01454596|EG008|Reported Event|Combined Steroids/no Steroids) - Cohort 6: 3x10(9)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077555|NCT01454596|EG009|Reported Event|Combined Steroids/no Steroids) - Cohort 7: 1x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11173630|NCT02016625|FG000|Participant Flow|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
11077556|NCT01454596|EG010|Reported Event|Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077557|NCT01454596|EG011|Reported Event|Combined Steroids/no Steroids) - Cohort 9: 3x10(10)|"After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.~Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr."
11077558|NCT01454726|BG000|Baseline|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
11077559|NCT01454726|BG001|Baseline|Control Group|receiving the Western medical treatment alone.
11077560|NCT01454726|BG002|Baseline|Total|Total of all reporting groups
11077561|NCT01454726|FG000|Participant Flow|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
11077562|NCT01454726|FG001|Participant Flow|Control Group|receiving the Western medical treatment alone.
11077563|NCT01454726|OG000|Outcome|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
11077564|NCT01454726|OG001|Outcome|Control Group|receiving the Western medical treatment alone.
11077565|NCT01454726|EG000|Reported Event|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
11077566|NCT01454726|EG001|Reported Event|Control Group|receiving the Western medical treatment alone.
11077567|NCT01454739|BG000|Baseline|rFVIIIFc (Participants From Study 8HA02PED)|"Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding prevention dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants less than (<)12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old."
11077568|NCT01454739|BG001|Baseline|rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)|"Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding prevention dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level."
11077569|NCT01454739|BG002|Baseline|Total|Total of all reporting groups
11077570|NCT01454739|FG000|Participant Flow|rFVIIIFc (Participants From Study 8HA02PED)|Participants received rFVIIIFc intravenously (IV) per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P(WP): rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding prevention dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
11077571|NCT01454739|FG001|Participant Flow|rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)|"Participants received rFVIIIFc IV as per their assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 international unit per kilogram (IU/kg)-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding prevention dose prior to strenuous activity; targeting FVIII trough level of greater than (>)3 percent (%), if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level."
11150312|NCT01876992|OG000|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm~, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.~Metformin"
11077572|NCT01454739|OG000|Outcome|rFVIIIFc (8HA02PED [<6 Years Old Age Cohort])|"Participants with < 6 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding prevention dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old."
11077573|NCT01454739|OG001|Outcome|rFVIIIFc (8HA02PED [6 to <12 Years Old Age Cohort])|"Participants with 6 to <12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding prevention dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old."
11077574|NCT01454739|OG002|Outcome|rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)|"Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding prevention dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level."
11227416|NCT02382939|FG001|Participant Flow|Somapacitan|"Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:~IGF-I SDS > 3: dose reduction by 1 mg 2 < IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 < IGF-I SDS ≤ 2: No need for dose adjustment~2 < IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg."
11077575|NCT01454739|OG002|Outcome|rFVIIIFc[Participants From Studies 997HA301/997HA307/997HA309]|"Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding prevention dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level."
11077576|NCT01454739|OG000|Outcome|rFVIIIFc (Participants From Study 8HA02PED)|"Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding prevention dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old."
11077577|NCT01454739|OG001|Outcome|rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)|"Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding prevention dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level."
11233729|NCT02430870|OG002|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11233730|NCT02430870|OG000|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11227417|NCT02382939|OG000|Outcome|Norditropin|"Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:~IGF-I SDS > 3: dose reduction by 0.1 mg/day 2 < IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 < IGF-I SDS ≤ 2: No need of dose adjustment~2 < IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum daily dose was set to 0.05 mg and 1.1 mg (Japan: maximum daily dose was 1.0 mg)."
11227418|NCT02382939|OG001|Outcome|Somapacitan|"Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:~IGF-I SDS > 3: dose reduction by 1 mg 2 < IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 < IGF-I SDS ≤ 2: No need for dose adjustment~2 < IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg."
11227419|NCT02382939|OG000|Outcome|Somapacitan|"Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:~IGF-I SDS > 3: dose reduction by 1 mg 2 < IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 < IGF-I SDS ≤ 2: No need for dose adjustment~2 < IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg."
11227420|NCT02382939|EG000|Reported Event|Norditropin|"Participants received s.c. injections of Norditropin daily for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of Norditropin was 0.2 mg/day (except females on oral oestrogen: 0.3 mg/day; participants older than 60 years: 0.1 mg/day). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:~IGF-I SDS > 3: dose reduction by 0.1 mg/day 2 < IGF-I SDS ≤ 3: dose reduction by 0.05 mg/day 0 < IGF-I SDS ≤ 2: No need of dose adjustment~2 < IGF-I SDS ≤ 0: Dose increment by 0.1 mg/day IGF-I SDS ≤ -2: Dose increment by 0.2 mg/day After the last dose adjustment (if any) at week 8, the individual dose level was fixed."
11227421|NCT02382939|EG001|Reported Event|Somapacitan|"Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:~IGF-I SDS > 3: dose reduction by 1 mg 2 < IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 < IGF-I SDS ≤ 2: No need for dose adjustment~2 < IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg."
11227422|NCT02382991|BG000|Baseline|Group NMPK Then 3C60|This arm group includes 17 participants who were first fitted with Non MicroProcessor-controlled Knee (30 days) then with 3C60 knee (90 days).
11227423|NCT02382991|BG001|Baseline|Group 3C60 Then NMPK|This arm group includes 18 participants who were first fitted with 3C60 knee (90 days) then had a washout period (10 days) then where fitted with Non MicroProcessor-controlled Kne (30 days).
11227424|NCT02382991|BG002|Baseline|Total|Total of all reporting groups
11227425|NCT02382991|FG000|Participant Flow|NMPK (30 Days), 3C60 (90 Days)|"D0 + 30 days: evaluation with the non-microprocessor knee. D1 + 90 days: evaluation with the 3C60 knee.~3C60-NMPK: 3 months with 3C60 - 10 days wash out - 1 month with NMPK"
11227426|NCT02382991|FG001|Participant Flow|3C60 (90 Days), Washout (10 Days), NMPK (30 Days)|"D0 + 90 days: evaluation with the 3C60 knee. A period of 10 days of wash out. D1 + 30 days: evaluation with the non-microprocessor knee.~NMPK-3C60: 1 month with NMPK - 3 months with 3C60"
11227427|NCT02382991|OG000|Outcome|Overall|
11227428|NCT02382991|EG000|Reported Event|NMPK|Participants with non microprocessor-controlled knee joint
11227429|NCT02382991|EG001|Reported Event|3C60|Participants with 3C60 knee joint
11227430|NCT02383017|BG000|Baseline|Shroom Tech Sport|"Shroom Tech Sport is a multi-ingredient performance supplement taken, in pill form, prior to work outs to enhance workout performance.~Shroom Tech Sport: STS will be given every day in accordance to company guidelines for 12 weeks."
11227431|NCT02383017|BG001|Baseline|Placebo|"The placebo is a calorie matched sugar pill that will be taken in the same fashion as the STS pill.~Placebo: Placebo will be given in the same fashion as the STS pills guidelines for 12 weeks."
11227432|NCT02383017|BG002|Baseline|Total|Total of all reporting groups
11227433|NCT02383017|FG000|Participant Flow|Shroom Tech Sport|This group consumed Shroom Tech Sport in accordance with manufacturer's instructions (one pill per 23kg (50lbs)) 45 minutes prior to exercise and testing and with breakfast on non-training days.
11227434|NCT02383017|FG001|Participant Flow|Placebo|This group consumed the placebo in accordance with the instructions provided for Shroom Tech Sport. Participants consumed one pill per 23kg (50lbs) 45 minutes before exercise and testing and with breakfast on non-training days.
11227435|NCT02383017|OG000|Outcome|Shroom Tech Sport|
11227436|NCT02383017|OG001|Outcome|Placebo|
11227437|NCT02383017|EG000|Reported Event|Shroom Tech Sport|"Shroom Tech Sport is a multi-ingredient performance supplement taken, in pill form, prior to work outs to enhance workout performance.~Shroom Tech Sport: STS will be given every day in accordance to company guidelines for 12 weeks."
11227438|NCT02383017|EG001|Reported Event|Placebo|"The placebo is a calorie matched sugar pill that will be taken in the same fashion as the STS pill.~Placebo: Placebo will be given in the same fashion as the STS pills guidelines for 12 weeks."
11227439|NCT02383043|BG000|Baseline|Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine|"Cocaine choice during Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance~Placebo and Cocaine~Placebo and Sustained Release d-Amphetamine"
11227440|NCT02383043|BG001|Baseline|30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine|"Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance~Placebo and Cocaine~Placebo and Sustained Release d-Amphetamine"
11227441|NCT02383043|BG002|Baseline|30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo|"Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance~Placebo and Cocaine~Placebo and Sustained Release d-Amphetamine"
11227442|NCT02383043|BG003|Baseline|Total|Total of all reporting groups
11077578|NCT01454739|EG000|Reported Event|rFVIIIFc (Participants From Study 8HA02PED)|"Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding prevention dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old."
11077579|NCT01454739|EG001|Reported Event|rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)|"Participants received rFVIIIFc IV as per their assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 international unit per kilogram (IU/kg)-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding prevention dose prior to strenuous activity; targeting FVIII trough level of greater than (>)3 percent (%), if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc IV based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level."
11077580|NCT01454739|EG002|Reported Event|Overall(Participants From 8HA02PED/997HA301/997HA307/997HA309)|All participants who received rFVIIIFc drug in study 8HA01EXT, from studies 8HA02PED and 97HA301/997HA307/997HA309. AEs emergent during major surgical/rehabilitation periods are excluded and are presented as separate groups.
11077581|NCT01454739|EG003|Reported Event|Participants From Study 8HA02PED- Surgery Subgroup|Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFVIIIFc as appropriate for the type of surgery. Participants returned to a regular rFVIIIFc regimen once all dosing for the postoperative rehabilitation period had been completed.
11077582|NCT01454739|EG004|Reported Event|Participants From 997HA301/997HA307/997HA309- Surgery Subgroup|Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFVIIIFc as appropriate for the type of surgery. Participants returned to a regular rFVIIIFc regimen once all dosing for the postoperative rehabilitation period had been completed.
11077583|NCT01454778|BG000|Baseline|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
11077584|NCT01454778|FG000|Participant Flow|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
11077585|NCT01454778|OG000|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
11077586|NCT01454778|EG000|Reported Event|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
11227443|NCT02383043|FG000|Participant Flow|Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine|"Cocaine choice during placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance~Placebo and Cocaine~Placebo and Sustained Release d-Amphetamine"
11227444|NCT02383043|FG001|Participant Flow|30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine|"Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance~Placebo and Cocaine~Placebo Sustained Release d-Amphetamine maintenance"
11227445|NCT02383043|FG002|Participant Flow|30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo|"Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance~Placebo and Cocaine~Placebo and Sustained Release d-Amphetamine"
11227446|NCT02383043|OG000|Outcome|30 mg d-Amphetamine|"Cocaine choice during 30 mg d-amphetamine maintenance~Placebo and Cocaine~Sustained Release d-Amphetamine"
11227447|NCT02383043|OG001|Outcome|Placebo Treatment|"Cocaine choice during placebo maintenance~Placebo and Cocaine~Placebo"
11227448|NCT02383043|OG002|Outcome|60 mg d-Amphetamine|"Cocaine choice during 60 mg d-amphetamine maintenance~Placebo and Cocaine~Sustained Release d-Amphetamine"
11077587|NCT01454791|BG000|Baseline|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
11077588|NCT01454791|BG001|Baseline|Placebo Followed by Diclofenac Sodium Gel|"placebo for 2 weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
11077589|NCT01454791|BG002|Baseline|Total|Total of all reporting groups
11077590|NCT01454791|FG000|Participant Flow|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
11077591|NCT01454791|FG001|Participant Flow|Placebo Followed by Diclofenac Sodium Topical Gel|"Placebo for two weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
11077592|NCT01454791|OG000|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
11077593|NCT01454791|OG001|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
11077594|NCT01454791|OG001|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day
11077595|NCT01454791|OG001|Outcome|Placebo|Placebo for two weeks: a placebo gel is applied 1-4 times per day
11077596|NCT01454791|EG000|Reported Event|Diclofenac Sodium Topical Gel|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).~diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
11077597|NCT01454791|EG001|Reported Event|Placebo|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).~diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
11077598|NCT01454830|BG000|Baseline|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
11077599|NCT01454830|BG001|Baseline|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
11077600|NCT01454830|BG002|Baseline|Total|Total of all reporting groups
11077601|NCT01454830|FG000|Participant Flow|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
11077602|NCT01454830|FG001|Participant Flow|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
11077603|NCT01454830|OG000|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
11077604|NCT01454830|OG001|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
11077605|NCT01454830|EG000|Reported Event|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
11077606|NCT01454830|EG001|Reported Event|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
11077607|NCT01454934|BG000|Baseline|Arm A: Eribulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered IV over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
11227449|NCT02383043|EG000|Reported Event|Medical Safety Session|Experimenter administered Placebo and Cocaine delivery. d-Amphetamine maintenance not yet initiated.
11227450|NCT02383043|EG001|Reported Event|Placebo|"Cocaine choice during placebo d-Amphetamine maintenance~Placebo and Cocaine"
11227451|NCT02383043|EG002|Reported Event|30 mg d-Amphetamine|"Cocaine choice during 30 mg d-Amphetamine maintenance~Placebo and Cocaine"
11077608|NCT01454934|BG001|Baseline|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|TPC: Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).
11077609|NCT01454934|BG002|Baseline|Total|Total of all reporting groups
11077610|NCT01454934|FG000|Participant Flow|Arm A: Eribulin Mesylate|Eribulin mesylate (1.4 milligram per square meter [mg/m^2]) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
11077611|NCT01454934|FG001|Participant Flow|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).
11077612|NCT01454934|OG000|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered IV over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
11077613|NCT01454934|OG001|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|TPC: Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).
11077614|NCT01454934|EG000|Reported Event|Arm A: Eribulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered IV over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
11077615|NCT01454934|EG001|Reported Event|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|TPC: Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).
11077616|NCT01454947|BG000|Baseline|Education Control|Participants do not receive any of the 3 interventions.
11077617|NCT01454947|BG001|Baseline|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
11077618|NCT01454947|BG002|Baseline|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
11077619|NCT01454947|BG003|Baseline|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
11077620|NCT01454947|BG004|Baseline|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
11077621|NCT01454947|BG005|Baseline|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
11077622|NCT01454947|BG006|Baseline|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
11077623|NCT01454947|BG007|Baseline|SA, AJ, PC|Participants are given all 3 interventions.
11077624|NCT01454947|BG008|Baseline|Total|Total of all reporting groups
11077625|NCT01454947|FG000|Participant Flow|Education Control|Participants do not receive any of the 3 interventions.
11077626|NCT01454947|FG001|Participant Flow|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
11077627|NCT01454947|FG002|Participant Flow|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
11077628|NCT01454947|FG003|Participant Flow|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
11077629|NCT01454947|FG004|Participant Flow|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
11077630|NCT01454947|FG005|Participant Flow|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
11077631|NCT01454947|FG006|Participant Flow|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
11227452|NCT02383043|EG003|Reported Event|60 mg d-Amphetamine|"Cocaine choice during 60 mg d-Amphetamine maintenance~Placebo and Cocaine"
11077632|NCT01454947|FG007|Participant Flow|SA, AJ, PC|Participants are given all 3 interventions.
11077633|NCT01454947|OG000|Outcome|Control|Participants received no study interventions
11077634|NCT01454947|OG001|Outcome|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
11077635|NCT01454947|OG002|Outcome|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
11077636|NCT01454947|OG003|Outcome|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
11077637|NCT01454947|OG004|Outcome|Suggested Alternatives + Accountable Justification|Participants receive the Suggested Alternatives and Accountable Justification interventions, but do not receive the Peer Comparison intervention
11077638|NCT01454947|OG005|Outcome|Suggested Alternatives + Peer Comparison|Participants receive the Suggested Alternatives and Peer Comparison interventions, but do not receive the Accountable Justification intervention
11077639|NCT01454947|OG006|Outcome|Accountable Justification + Peer Comparison|Participants receive the Accountable Justification and Peer Comparison interventions, but do not receive the Suggested Alternatives intervention
11077640|NCT01454947|OG007|Outcome|SA+AJ+PC|Participants receive all three interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison interventions
11077641|NCT01454947|EG000|Reported Event|Education Control|Participants do not receive any of the 3 interventions.
11077642|NCT01454947|EG001|Reported Event|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
11077643|NCT01454947|EG002|Reported Event|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
11077644|NCT01454947|EG003|Reported Event|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
11077645|NCT01454947|EG004|Reported Event|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
11077646|NCT01454947|EG005|Reported Event|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
11077647|NCT01454947|EG006|Reported Event|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
11077648|NCT01454947|EG007|Reported Event|SA, AJ, PC|Participants are given all 3 interventions.
11077649|NCT01455012|BG000|Baseline|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
11077650|NCT01455012|BG001|Baseline|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
11077651|NCT01455012|BG002|Baseline|Total|Total of all reporting groups
11077652|NCT01455012|FG000|Participant Flow|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
11077653|NCT01455012|FG001|Participant Flow|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
11077654|NCT01455012|OG000|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
11077655|NCT01455012|OG001|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
11077656|NCT01455012|EG000|Reported Event|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
11077657|NCT01455012|EG001|Reported Event|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
11077658|NCT01455064|BG000|Baseline|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
11077659|NCT01455064|FG000|Participant Flow|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
11077660|NCT01455064|OG000|Outcome|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
11077661|NCT01455064|EG000|Reported Event|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
11077662|NCT01455181|BG000|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
11077663|NCT01455181|FG000|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
11077664|NCT01455181|OG000|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
11077665|NCT01455181|EG000|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
11077666|NCT01455194|BG000|Baseline|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077667|NCT01455194|BG001|Baseline|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077668|NCT01455194|BG002|Baseline|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077669|NCT01455194|BG003|Baseline|Total|Total of all reporting groups
11150313|NCT01876992|EG000|Reported Event|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.~Metformin"
11150314|NCT01876992|EG001|Reported Event|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
11150315|NCT01877083|BG000|Baseline|Lenvatinib 24 mg|Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
11150316|NCT01877083|FG000|Participant Flow|Lenvatinib 24 mg|Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 milligram (mg), capsule, orally, once daily in 28-day continuous cycles until disease progression (PD), development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
11150317|NCT01877083|OG000|Outcome|Lenvatinib 24 mg|Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
11150318|NCT01877083|EG000|Reported Event|Lenvatinib 24 mg|Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
11150319|NCT01877148|BG000|Baseline|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
11150320|NCT01877148|BG001|Baseline|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
11150321|NCT01877148|BG002|Baseline|Total|Total of all reporting groups
11150322|NCT01877148|FG000|Participant Flow|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
11150323|NCT01877148|FG001|Participant Flow|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
11150324|NCT01877148|OG000|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
11150325|NCT01877148|OG001|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
11150326|NCT01877148|EG000|Reported Event|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
11173631|NCT02016625|FG001|Participant Flow|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
11077670|NCT01455194|FG000|Participant Flow|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period.
11077671|NCT01455194|FG001|Participant Flow|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077672|NCT01455194|FG002|Participant Flow|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077673|NCT01455194|FG003|Participant Flow|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077674|NCT01455194|OG000|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077675|NCT01455194|OG001|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077676|NCT01455194|OG002|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077677|NCT01455194|OG000|Outcome|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
11077678|NCT01455194|OG001|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077679|NCT01455194|OG002|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077680|NCT01455194|OG003|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077681|NCT01455194|EG000|Reported Event|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
11077682|NCT01455194|EG001|Reported Event|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077683|NCT01455194|EG002|Reported Event|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077684|NCT01455194|EG003|Reported Event|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
11077685|NCT01455220|BG000|Baseline|Tysabri|All patients were receiving commercial Tysabri
11077686|NCT01455220|FG000|Participant Flow|All Patients|
11077687|NCT01455220|OG000|Outcome|Baseline to 6 Months (MSISQ-19 Scores)|All enrolled participants
11077688|NCT01455220|OG000|Outcome|MSQOL-54, Physical (Baseline to 6 Months)|
11077689|NCT01455220|OG000|Outcome|FAMS (Baseline to 6 Months)|
11077690|NCT01455220|OG000|Outcome|MSQOL-54 Total (Baseline to 6 Months)|
11077691|NCT01455220|EG000|Reported Event|All Patients|no Adverse events were experienced
11077692|NCT01455415|BG000|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11077693|NCT01455415|BG001|Baseline|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11077694|NCT01455415|BG002|Baseline|Total|Total of all reporting groups
11077695|NCT01455415|FG000|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11077696|NCT01455415|FG001|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11077697|NCT01455415|OG000|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11077698|NCT01455415|OG001|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11077699|NCT01455415|EG000|Reported Event|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11173632|NCT02016625|OG000|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
11077700|NCT01455415|EG001|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11077701|NCT01455428|BG000|Baseline|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
11077702|NCT01455428|BG001|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
11077703|NCT01455428|BG002|Baseline|Total|Total of all reporting groups
11077704|NCT01455428|FG000|Participant Flow|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
11077705|NCT01455428|FG001|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
11077706|NCT01455428|OG000|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
11077707|NCT01455428|OG001|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
11077708|NCT01455428|EG000|Reported Event|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
11077709|NCT01455428|EG001|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
11077710|NCT01455519|BG000|Baseline|Sugar Pill|Subjects may receive a pill with no medicine.
11077711|NCT01455519|BG001|Baseline|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER~Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
11077712|NCT01455519|BG002|Baseline|Total|Total of all reporting groups
11077713|NCT01455519|FG000|Participant Flow|Sugar Pill|Subjects may receive a pill with no medicine.
11077714|NCT01455519|FG001|Participant Flow|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
11077715|NCT01455519|OG000|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
11077716|NCT01455519|OG001|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
11077717|NCT01455519|EG000|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
11173633|NCT02016625|OG001|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
11173634|NCT02016625|OG000|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
11173635|NCT02016625|OG000|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
11173636|NCT02016625|OG001|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
11173637|NCT02016625|OG001|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1, treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
11173638|NCT02016625|OG000|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by tac treatment] in period 2
11173639|NCT02016625|OG000|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
11173640|NCT02016625|EG000|Reported Event|Cyclosporine (Cyclo)|Cyclosporine (cyclo) 50 mg
11077718|NCT01455519|EG001|Reported Event|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER~Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
11077719|NCT01455545|BG000|Baseline|Asthmatic Patients|"Patient group with bad control defined as participants with an Asthma Control Test (ACT) score = or < 19. Patient group with good control defined as participants with an Asthma Control Test (ACT)score > 19.~In both groups there were patients with mild, moderate and severe asthma according the Global Initiative for Asthma (GINA)."
11077720|NCT01455545|FG000|Participant Flow|Bad Control|Patient group with bad control defined as participants with an Asthma Control Test (ACT) = or < 19 points.
11077721|NCT01455545|FG001|Participant Flow|Good Control|Patient group with good control defined as participants with an Asthma Control Test (ACT)> 19 points.
11077722|NCT01455545|OG000|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
11077723|NCT01455545|OG001|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
11077724|NCT01455545|OG000|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
11077725|NCT01455545|OG001|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
11077726|NCT01455545|OG000|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
11077727|NCT01455545|OG001|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
11077728|NCT01455545|OG000|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19.
11077729|NCT01455545|OG000|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
11077730|NCT01455545|OG000|Outcome|Bad Control|Patients with asthma and bad control. Bad control if ACT score < or = 19.
11077731|NCT01455545|OG001|Outcome|Good Control|Patients with asthma and goog control. Good control if ACT score > 19.
11077732|NCT01455545|OG001|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19 .
11077733|NCT01455545|EG000|Reported Event|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Good control less than 20 score.
11077734|NCT01455545|EG001|Reported Event|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control more than 19 score.
11077735|NCT01456000|BG000|Baseline|EAS-AC (HeartLight)|"Treatment with the EAS-AC. Randomized and treated cohort.~EAS-AC (HeartLight): Pulmonary vien isolation"
11077736|NCT01456000|BG001|Baseline|Control Arm Ablation|"Treatment with standard ablation. Randomized and treated cohort.~Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation."
11077737|NCT01456000|BG002|Baseline|Total|Total of all reporting groups
11077738|NCT01456000|FG000|Participant Flow|EAS-AC (HeartLight)|"Treatment with the EAS-AC.~EAS-AC (HeartLight): Pulmonary vien isolation~ITT Population 178 participants"
11077739|NCT01456000|FG001|Participant Flow|Control Arm Ablation|"Treatment with standard ablation.~Control Arm Ablation: Treatment with standard ablation.~ITT Population 175 Participants"
11077740|NCT01456000|OG000|Outcome|EAS-AC (HeartLight)|"Treatment with the EAS-AC and evaluable for efficacy.~EAS-AC (HeartLight): Pulmonary vien isolation"
11077741|NCT01456000|OG001|Outcome|Control Arm Ablation|"Treatment with standard ablation and evaluable for efficacy.~Control Arm Ablation: Treatment with standard ablation."
11077742|NCT01456000|EG000|Reported Event|EAS-AC (HeartLight)|"Treatment with the EAS-AC.~EAS-AC (HeartLight): Pulmonary vien isolation~ITT Population 178 participants"
11077743|NCT01456000|EG001|Reported Event|Control Arm Ablation|"Treatment with standard ablation.~Control Arm Ablation: Treatment with standard ablation.~ITT Population 175 Participants"
11077744|NCT01456039|BG000|Baseline|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
11077745|NCT01456039|BG001|Baseline|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077746|NCT01456039|BG002|Baseline|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077747|NCT01456039|BG003|Baseline|Total|Total of all reporting groups
11077748|NCT01456039|FG000|Participant Flow|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
11077749|NCT01456039|FG001|Participant Flow|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077750|NCT01456039|FG002|Participant Flow|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077751|NCT01456039|OG000|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
11077752|NCT01456039|OG001|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077753|NCT01456039|OG000|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
11077754|NCT01456039|OG001|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077755|NCT01456039|OG002|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077756|NCT01456039|OG003|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11173641|NCT02016625|EG001|Reported Event|Tacrolimus (Tac)|Tacrolimus (tac) 0.5 mg
11077757|NCT01456039|OG000|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077758|NCT01456039|OG001|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077759|NCT01456039|OG002|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077760|NCT01456039|OG000|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077761|NCT01456039|EG000|Reported Event|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
11077762|NCT01456039|EG001|Reported Event|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077763|NCT01456039|EG002|Reported Event|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077764|NCT01456039|EG003|Reported Event|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
11077765|NCT01456052|BG000|Baseline|Placebo|Matching placebo administered orally.
11077766|NCT01456052|BG001|Baseline|Low Dose Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
11077767|NCT01456052|BG002|Baseline|High Dose Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally three times daily (TID)
11077768|NCT01456052|BG003|Baseline|Total|Total of all reporting groups
11077769|NCT01456052|FG000|Participant Flow|Placebo|Placebo: Matching placebo administered orally.
11077770|NCT01456052|FG001|Participant Flow|Low Dose Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
11077771|NCT01456052|FG002|Participant Flow|High Dose Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
11077772|NCT01456052|OG000|Outcome|Placebo|Matching placebo administered orally.
11077773|NCT01456052|OG001|Outcome|Low Dose LX1606|500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
11077774|NCT01456052|OG002|Outcome|High Dose Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
11077775|NCT01456052|OG001|Outcome|Low Dose Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
11077776|NCT01456052|EG000|Reported Event|Placebo|Matching placebo administered orally.
11077777|NCT01456052|EG001|Reported Event|Low Dose Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
11077778|NCT01456052|EG002|Reported Event|High Dose Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
11077779|NCT01456130|BG000|Baseline|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
11077780|NCT01456130|FG000|Participant Flow|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
11077781|NCT01456130|OG000|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
11077782|NCT01456130|EG000|Reported Event|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
11077783|NCT01456143|BG000|Baseline|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
11077784|NCT01456143|FG000|Participant Flow|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
11077785|NCT01456143|OG000|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
11077786|NCT01456143|EG000|Reported Event|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
11077787|NCT01456169|BG000|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
11077788|NCT01456169|BG001|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
11077789|NCT01456169|BG002|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
11077790|NCT01456169|BG003|Baseline|Total|Total of all reporting groups
11077791|NCT01456169|FG000|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
11077792|NCT01456169|FG001|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
11077793|NCT01456169|FG002|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
11077794|NCT01456169|OG000|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
11077795|NCT01456169|OG001|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
11077796|NCT01456169|OG002|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
11077797|NCT01456169|EG000|Reported Event|Monotherapy: Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for 4 weeks during the Single-Blind Monotherapy Treatment Period. All enrolled participants, including those who were not randomized to double-blind treatment are included in this group.
11077798|NCT01456169|EG001|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
11077799|NCT01456169|EG002|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
11077800|NCT01456169|EG003|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
11077801|NCT01456195|BG000|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
11077802|NCT01456195|BG001|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
11077803|NCT01456195|BG002|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
11077804|NCT01456195|BG003|Baseline|Total|Total of all reporting groups
11077805|NCT01456195|FG000|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
11077806|NCT01456195|FG001|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
11077807|NCT01456195|FG002|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
11077808|NCT01456195|OG000|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
11077809|NCT01456195|OG001|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
11077810|NCT01456195|OG002|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
11077811|NCT01456195|EG000|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
11077812|NCT01456195|EG001|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
11077813|NCT01456195|EG002|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
11077814|NCT01456221|BG000|Baseline|Omega 3 and an Hypocaloric Diet|"Participants will receive a supplement containing omega 3: DHA and EPA fatty acids together with an hypocaloric diet.~Omega3 and an hypocaloric diet.: Thirty caps with the supplement will be provided every mo during three mo. Supplement will be administered as gel caps containing 1.1 g of DHA and EPA (®MaxEpa, Merck Laboratory) Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains."
11077815|NCT01456221|BG001|Baseline|Placebo|"Participants will receive a supplement containing sunflower oil with an hypocaloric diet.~Sunflower oil with an hypocaloric diet.: Thirty caps with the placebo will be provided every mo during three mo. Placebo will be administered as gel caps containing 1g of sunflower oil, which is omega-3 free, and is not expected to produce anti-inflammatory or insulin sensitivity effects. Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains."
11077816|NCT01456221|BG002|Baseline|Total|Total of all reporting groups
11077817|NCT01456221|FG000|Participant Flow|Omega 3 and an Hypocaloric Diet|"Participants will receive a supplement containing omega 3: Docosahexaenoic acid (DHA) and EPA fatty acids together with an hypocaloric diet.~Omega3 and an hypocaloric diet.: Thirty caps with the supplement will be provided every mo during three mo. Supplement will be administered as gel caps containing 1.1 g of DHA and EPA (®MaxEpa, Merck Laboratory) Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains."
11077818|NCT01456221|FG001|Participant Flow|Placebo|"Participants will receive a supplement containing sunflower oil with an hypocaloric diet.~Sunflower oil with an hypocaloric diet.: Thirty caps with the placebo will be provided every mo during three mo. Placebo will be administered as gel caps containing 1g of sunflower oil, which is omega-3 free, and is not expected to produce anti-inflammatory or insulin sensitivity effects. Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains."
11077819|NCT01456221|OG000|Outcome|Omega 3 and an Hypocaloric Diet|"Participants will receive a supplement containing omega 3: DHA and EPA fatty acids together with an hypocaloric diet.~Omega3 and an hypocaloric diet.: Thirty caps with the supplement will be provided every mo during three mo. Supplement will be administered as gel caps containing 1.1 g of DHA and EPA (®MaxEpa, Merck Laboratory) Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains."
11173642|NCT02016625|EG002|Reported Event|FDV (ff Cyclo)|FDV 120 mg (followed by cyclosporine)
11173643|NCT02016625|EG003|Reported Event|FDV (ff Tac)|FDV 120 mg (followed by tacrolimus)
11173644|NCT02016625|EG004|Reported Event|Cyclo+FDV|Cyclosporine 50 mg + FDV 120 mg
11173645|NCT02016625|EG005|Reported Event|Tac+FDV|Tacrolimus 0.5 mg + FDV 120 mg
11077820|NCT01456221|OG001|Outcome|Placebo|"Participants will receive a supplement containing sunflower oil with an hypocaloric diet.~Sunflower oil with an hypocaloric diet.: Thirty caps with the placebo will be provided every mo during three mo. Placebo will be administered as gel caps containing 1g of sunflower oil, which is omega-3 free, and is not expected to produce anti-inflammatory or insulin sensitivity effects. Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains."
11077821|NCT01456221|EG000|Reported Event|Omega 3 and an Hypocaloric Diet|"Participants will receive a supplement containing omega 3: DHA and EPA fatty acids together with an hypocaloric diet.~Omega3 and an hypocaloric diet.: Thirty caps with the supplement will be provided every mo during three mo. Supplement will be administered as gel caps containing 1.1 g of DHA and EPA (®MaxEpa, Merck Laboratory) Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains."
11077822|NCT01456221|EG001|Reported Event|Placebo|"Participants will receive a supplement containing sunflower oil with an hypocaloric diet.~Sunflower oil with an hypocaloric diet.: Thirty caps with the placebo will be provided every mo during three mo. Placebo will be administered as gel caps containing 1g of sunflower oil, which is omega-3 free, and is not expected to produce anti-inflammatory or insulin sensitivity effects. Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains."
11077823|NCT01456299|BG000|Baseline|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
11077824|NCT01456299|BG001|Baseline|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
11077825|NCT01456299|BG002|Baseline|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
11077826|NCT01456299|BG003|Baseline|Total|Total of all reporting groups
11077827|NCT01456299|FG000|Participant Flow|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
11077828|NCT01456299|FG001|Participant Flow|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
11077829|NCT01456299|FG002|Participant Flow|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
11077830|NCT01456299|OG000|Outcome|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
11077831|NCT01456299|OG001|Outcome|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
11077832|NCT01456299|OG002|Outcome|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
11077833|NCT01456299|EG000|Reported Event|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
11077834|NCT01456299|EG001|Reported Event|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
11077835|NCT01456299|EG002|Reported Event|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
11077836|NCT01456494|BG000|Baseline|Teach-to-Goal|"Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.~Teach-to-Goal Education: Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension."
11077837|NCT01456494|BG001|Baseline|Brief Intervention|"A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.~Brief Intervention: A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers."
11077838|NCT01456494|BG002|Baseline|Total|Total of all reporting groups
11077839|NCT01456494|FG000|Participant Flow|Teach-to-Goal|"Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.~Teach-to-Goal Education: Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.~N=24"
11077840|NCT01456494|FG001|Participant Flow|Brief Intervention|"A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.~Brief Intervention: A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.~N=26"
11077841|NCT01456494|OG000|Outcome|Teach-to-Goal|"Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.~Teach-to-Goal Education: Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.~N=24"
11077842|NCT01456494|OG001|Outcome|Brief Intervention|"A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.~Brief Intervention: A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.~N=26"
11077843|NCT01456494|EG000|Reported Event|Teach-to-Goal|"Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.~Teach-to-Goal Education: Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.~N=24"
11077844|NCT01456494|EG001|Reported Event|Brief Intervention|"A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.~Brief Intervention: A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.~N=26"
11077845|NCT01456780|BG000|Baseline|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
11077846|NCT01456780|BG001|Baseline|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
11077847|NCT01456780|BG002|Baseline|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
11077848|NCT01456780|BG003|Baseline|Total|Total of all reporting groups
11077849|NCT01456780|FG000|Participant Flow|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
11077850|NCT01456780|FG001|Participant Flow|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
11077851|NCT01456780|FG002|Participant Flow|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
11077852|NCT01456780|OG000|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
11077853|NCT01456780|OG001|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
11077854|NCT01456780|OG002|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
11077855|NCT01456780|EG000|Reported Event|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
11077856|NCT01456780|EG001|Reported Event|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling).~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
11077857|NCT01456780|EG002|Reported Event|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
11077858|NCT01456897|BG000|Baseline|New Subjects|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in this trial
11077859|NCT01456897|BG001|Baseline|Rollover Subjects|Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
11077860|NCT01456897|BG002|Baseline|Total|Total of all reporting groups
11077861|NCT01456897|FG000|Participant Flow|New Subjects|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in this trial
11077862|NCT01456897|FG001|Participant Flow|Rollover Subjects|Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
11077863|NCT01456897|OG000|Outcome|New Subjects|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in this trial
11077864|NCT01456897|OG001|Outcome|Rollover Subjects|Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
11077865|NCT01456897|EG000|Reported Event|New Subjects|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in this trial
11077866|NCT01456897|EG001|Reported Event|Rollover Subjects|Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
11077867|NCT01456936|BG000|Baseline|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
11077868|NCT01456936|BG001|Baseline|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
11077869|NCT01456936|BG002|Baseline|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
11077870|NCT01456936|BG003|Baseline|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
11077871|NCT01456936|BG004|Baseline|Total|Total of all reporting groups
11077872|NCT01456936|FG000|Participant Flow|Varenicline|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg daily once (QD) x 3 days, 0.5 mg twice daily (BID) x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
11077873|NCT01456936|FG001|Participant Flow|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
11077874|NCT01456936|FG002|Participant Flow|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
11077875|NCT01456936|FG003|Participant Flow|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
11077876|NCT01456936|OG000|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
11077877|NCT01456936|OG001|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
11077878|NCT01456936|OG002|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
11077879|NCT01456936|OG003|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
11077880|NCT01456936|EG000|Reported Event|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
11077881|NCT01456936|EG001|Reported Event|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
11077882|NCT01456936|EG002|Reported Event|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
11077883|NCT01456936|EG003|Reported Event|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
11077884|NCT01456949|BG000|Baseline|Modified Intent to Treat Group (mITT)|Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.
11077885|NCT01456949|FG000|Participant Flow|Single Arm|"Cryoablation~Medtronic Arctic Front® Cardiac CryoAblation System: Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed."
11077886|NCT01456949|OG000|Outcome|Modified Intent to Treat Group (mITT)|Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.
11077887|NCT01456949|EG000|Reported Event|Treated Group|Enrolled subjects who underwent a study cryoablation procedure whether or not they met all inclusion/exclusion criteria.
11077888|NCT01456962|BG000|Baseline|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
11077889|NCT01456962|BG001|Baseline|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
11077890|NCT01456962|BG002|Baseline|Total|Total of all reporting groups
11077891|NCT01456962|FG000|Participant Flow|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
11077892|NCT01456962|FG001|Participant Flow|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
11077893|NCT01456962|OG000|Outcome|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
11077894|NCT01456962|OG001|Outcome|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
11077895|NCT01456962|EG000|Reported Event|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
11077896|NCT01456962|EG001|Reported Event|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
11077897|NCT01457014|BG000|Baseline|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
11077898|NCT01457014|FG000|Participant Flow|Diagnostic Polysomnography (PSG)|A Diagnostic PSG was performed using the core equipment available to determine eligibility into the overnight portion of the study.
11077899|NCT01457014|FG001|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
11077900|NCT01457014|FG002|Participant Flow|Servo Ventilation Auto Mode (autoSV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
11077901|NCT01457014|FG003|Participant Flow|Servo Ventilation Manual (Manual SV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
11077902|NCT01457014|OG000|Outcome|Diagnostic Polysomnography (PSG)|Baseline overnight Polysomnography (PSG)
11077903|NCT01457014|OG001|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
11077904|NCT01457014|OG002|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
11077905|NCT01457014|OG003|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
11077906|NCT01457014|OG000|Outcome|Diagnostic PSG|Baseline overnight PSG.
11077907|NCT01457014|EG000|Reported Event|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
11077908|NCT01457118|BG000|Baseline|145 mg/m2|NKTR-102: A 90 minute IV infusion of 145 mg/m2
11077909|NCT01457118|BG001|Baseline|120 mg/m2|NKTR-102: A 90 minute IV infusion of 120 mg/m2
11077910|NCT01457118|BG002|Baseline|95 mg/m2|NKTR-102: A 90 minute IV infusion of 95 mg/m2
11077911|NCT01457118|BG003|Baseline|50 mg/m2|NKTR-102: A 90 minute IV infusion of 50 mg/m2
11077912|NCT01457118|BG004|Baseline|Total|Total of all reporting groups
11077913|NCT01457118|FG000|Participant Flow|145 mg/m2|NKTR-102: A 90 minute IV infusion of 145 mg/m2
11077914|NCT01457118|FG001|Participant Flow|120 mg/m2|NKTR-102: A 90 minute IV infusion of 120 mg/m2
11077915|NCT01457118|FG002|Participant Flow|95 mg/m2|NKTR-102: A 90 minute IV infusion of 95 mg/m2
11077916|NCT01457118|FG003|Participant Flow|50 mg/m2|NKTR-102: A 90 minute IV infusion of 50 mg/m2
11077917|NCT01457118|OG000|Outcome|145 mg/m2|NKTR-102: A 90 minute IV infusion of 145 mg/m2
11077918|NCT01457118|OG001|Outcome|120 mg/m2|NKTR-102: A 90 minute IV infusion of 120 mg/m2
11077919|NCT01457118|OG002|Outcome|95 mg/m2|NKTR-102: A 90 minute IV infusion of 95 mg/m2
11077920|NCT01457118|OG003|Outcome|50 mg/m2|NKTR-102: A 90 minute IV infusion of 50 mg/m2
11077921|NCT01457118|EG000|Reported Event|145 mg/m2|NKTR-102: A 90 minute IV infusion of 145 mg/m2
11077922|NCT01457118|EG001|Reported Event|120 mg/m2|NKTR-102: A 90 minute IV infusion of 120 mg/m2
11077923|NCT01457118|EG002|Reported Event|95 mg/m2|NKTR-102: A 90 minute IV infusion of 95 mg/m2
11077924|NCT01457118|EG003|Reported Event|50 mg/m2|NKTR-102: A 90 minute IV infusion of 50 mg/m2
11077925|NCT01457196|BG000|Baseline|Sequencing Arm|All eligible subjects who had Tumor Genetic Sequencing performed. This sequencing looked at genetic material from a sample of the subjects tumor and certain changes in the genetic material, to see if these changes are related to the subjects cancer.
11077926|NCT01457196|FG000|Participant Flow|Sequencing Arm|All eligible subjects who had Tumor Genetic Sequencing performed. This sequencing looked at genetic material from a sample of the subjects tumor and certain changes in the genetic material, to see if these changes are related to the subjects cancer.
11077927|NCT01457196|OG000|Outcome|Sequencing Arm|Tumor Genetic Sequencing: This study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer.
11077928|NCT01457196|OG000|Outcome|Reported|Subjects with next-generation sequencing who had somatic variants identified by the University of North Carolina (UNC )Molecular Tumor Board as actionable that were unknown at the time of testing reported to their treating physicians.
11077929|NCT01457196|OG001|Outcome|Not Reported|Subjects with next-generation sequencing who had no somatic variants identified by the UNC Molecular Tumor Board as actionable that were unknown at the time of testing reported to their treating physicians.
11077930|NCT01457196|EG000|Reported Event|Sequencing Arm|All eligible subjects who had Tumor Genetic Sequencing performed. This sequencing looked at genetic material from a sample of the subjects tumor and certain changes in the genetic material, to see if these changes are related to the subjects cancer.
11077931|NCT01457339|BG000|Baseline|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
11077932|NCT01457339|BG001|Baseline|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077933|NCT01457339|BG002|Baseline|Total|Total of all reporting groups
11077934|NCT01457339|FG000|Participant Flow|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
11077935|NCT01457339|FG001|Participant Flow|SPD489 (Lisdexamfetamine Dimesylate)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077936|NCT01457339|OG000|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
11077937|NCT01457339|OG001|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
11077938|NCT01457339|OG001|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
11077939|NCT01457339|OG001|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
11077940|NCT01457339|OG000|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
11077941|NCT01457339|OG000|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
11077942|NCT01457339|OG000|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
11077943|NCT01457339|OG000|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
11077944|NCT01457339|OG000|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
11077945|NCT01457339|OG000|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
11077946|NCT01457339|OG001|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
11077947|NCT01457339|OG001|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
11077948|NCT01457339|OG001|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
11077949|NCT01457339|EG000|Reported Event|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
11077950|NCT01457339|EG001|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077951|NCT01457339|EG002|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077952|NCT01457339|EG003|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077953|NCT01457339|EG004|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077954|NCT01457339|EG005|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077955|NCT01457339|EG006|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077956|NCT01457339|EG007|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
11077957|NCT01457352|BG000|Baseline|SPARC0921|SPARC0921 Subjects who received SPARC0921 Dose Regimen I at Visit 1: 392 Received SPARC0921 Dose Regimen II at Visit 2 (Safety Population): 376 Randomized at Visit 7 to receive Dose Regimen III: 147
11077958|NCT01457352|BG001|Baseline|Placebo0921|"Placebo0921~Randomized at Visit 7: 149"
11077959|NCT01457352|BG002|Baseline|Total|Total of all reporting groups
11077960|NCT01457352|FG000|Participant Flow|SPARC0921|once, twice, thrice, or four times daily for one week
11077961|NCT01457352|FG001|Participant Flow|Placebo|Placebo formulation
11077962|NCT01457352|OG000|Outcome|SPARC0921|SPARC0921
11077963|NCT01457352|OG001|Outcome|Placebo0921|Placebo0921
11077964|NCT01457352|OG000|Outcome|SPARC0921|Subject Global Impression of Severity of Spasticity in SPARC0921 group
11077965|NCT01457352|OG001|Outcome|Placebo0921|Subject Global Impression of Severity of Spasticity in Placebo0921 group
11077966|NCT01457352|EG000|Reported Event|SPARC0921- Part 3|SPARC0921 in randomized phase
11077967|NCT01457352|EG001|Reported Event|Placebo0921 - Part 3|Placebo0921 in randomized phase
11077968|NCT01457352|EG002|Reported Event|SPARC 0921 - Part 2|Open label
11077969|NCT01457352|EG003|Reported Event|Run-in Part 1|Open label run-in period
11091877|NCT01536561|EG000|Reported Event|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11091878|NCT01536561|EG001|Reported Event|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:&gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
11091879|NCT01536574|BG000|Baseline|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
11091880|NCT01536574|BG001|Baseline|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
11091881|NCT01536574|BG002|Baseline|Total|Total of all reporting groups
11091882|NCT01536574|FG000|Participant Flow|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
11091883|NCT01536574|FG001|Participant Flow|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
11173646|NCT02016690|BG000|Baseline|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
11173647|NCT02016690|FG000|Participant Flow|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
11077970|NCT01457417|BG000|Baseline|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077971|NCT01457417|BG001|Baseline|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
11077972|NCT01457417|BG002|Baseline|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077973|NCT01457417|BG003|Baseline|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077974|NCT01457417|BG004|Baseline|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
11077975|NCT01457417|BG005|Baseline|Total|Total of all reporting groups
11077976|NCT01457417|FG000|Participant Flow|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077977|NCT01457417|FG001|Participant Flow|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
11077978|NCT01457417|FG002|Participant Flow|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11227453|NCT02383056|BG000|Baseline|Sham Group (Group 1)|"This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes~Omnilux sham light"
11227454|NCT02383056|BG001|Baseline|Treatment Group (Group 2)|"This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes~Omnilux: 633nm"
11077979|NCT01457417|FG003|Participant Flow|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077980|NCT01457417|FG004|Participant Flow|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
11077981|NCT01457417|OG000|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077982|NCT01457417|OG001|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
11077983|NCT01457417|OG002|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077984|NCT01457417|OG003|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077985|NCT01457417|OG004|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
11077986|NCT01457417|OG005|Outcome|Total|Total across all treatment groups
11077987|NCT01457417|OG000|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
11077988|NCT01457417|EG000|Reported Event|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077989|NCT01457417|EG001|Reported Event|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
11150327|NCT01877148|EG001|Reported Event|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
11227455|NCT02383056|BG002|Baseline|Total|Total of all reporting groups
11077990|NCT01457417|EG002|Reported Event|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077991|NCT01457417|EG003|Reported Event|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
11077992|NCT01457417|EG004|Reported Event|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
11077993|NCT01457430|BG000|Baseline|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
11077994|NCT01457430|FG000|Participant Flow|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
11077995|NCT01457430|OG000|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
11077996|NCT01457430|OG001|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
11077997|NCT01457430|EG000|Reported Event|Icatibant|"Open-label study~Icatibant: 30 mg subcutaneous dose of Icatibant"
11077998|NCT01457521|BG000|Baseline|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
11077999|NCT01457521|BG001|Baseline|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
11078000|NCT01457521|BG002|Baseline|Total|Total of all reporting groups
11078001|NCT01457521|FG000|Participant Flow|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
11078002|NCT01457521|FG001|Participant Flow|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
11078003|NCT01457521|OG000|Outcome|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
11078004|NCT01457521|OG001|Outcome|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
11078005|NCT01457521|EG000|Reported Event|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
11078006|NCT01457521|EG001|Reported Event|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
11078007|NCT01457573|BG000|Baseline|All Study Participants|Men > 50 years old with urinary frequency symptoms, who entered study not taking any bladder related medications and on study took tamsulosin and solifenacin orally everyday throughout the study with follow-up assessments at Month 1/week 4, Month 2 week 8, and Month 3/week 12.
11078008|NCT01457573|FG000|Participant Flow|Single Arm (Tamsulosin and Solifenacin)|10 Men with lower urinary tract symptoms (LUTS), consistent with BPH, were screened in our urology clinics for participation in a clinical trial.
11078009|NCT01457573|OG000|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
11078010|NCT01457573|OG000|Outcome|Baseline Characteristics|Men > 50 years old with symptomatic LUTS (IPSS > 8), PSA < 10, PVR < 150 mls and maximum urinary flow rate > 10 mls/sec could enter the trial.
11078011|NCT01457573|EG000|Reported Event|Participant Flow|10 Men with lower urinary tract symptoms (LUTS), consistent with BPH, were screened in our urology clinics for participation in a clinical trial.
11078012|NCT01457703|BG000|Baseline|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
11078013|NCT01457703|BG001|Baseline|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
11078014|NCT01457703|BG002|Baseline|Total|Total of all reporting groups
11078015|NCT01457703|FG000|Participant Flow|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
11078016|NCT01457703|FG001|Participant Flow|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
11078017|NCT01457703|OG000|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
11078018|NCT01457703|OG001|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
11078019|NCT01457703|OG000|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
11078020|NCT01457703|OG001|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
11078021|NCT01457703|EG000|Reported Event|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
11078022|NCT01457703|EG001|Reported Event|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
11078023|NCT01457846|BG000|Baseline|Paclitaxel|80mg / m^2
11078024|NCT01457846|BG001|Baseline|AZD4547|80mg BD 2 weeks on/1 week off
11078025|NCT01457846|BG002|Baseline|Total|Total of all reporting groups
11078026|NCT01457846|FG000|Participant Flow|AZD4547|80mg BD 2 weeks on/1 week off
11078027|NCT01457846|FG001|Participant Flow|Paclitaxel|80mg / m^2
11078028|NCT01457846|OG000|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
11078029|NCT01457846|OG001|Outcome|Paclitaxel|80mg / m^2
11078030|NCT01457846|EG000|Reported Event|AZD4547|80mg BD 2 weeks on/1 week off
11078031|NCT01457846|EG001|Reported Event|Paclitaxel|80mg / m^2
11078032|NCT01457885|BG000|Baseline|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
11078033|NCT01457885|FG000|Participant Flow|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
11078034|NCT01457885|OG000|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
11078035|NCT01457885|EG000|Reported Event|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
11078036|NCT01457924|BG000|Baseline|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078037|NCT01457924|BG001|Baseline|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078038|NCT01457924|BG002|Baseline|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078039|NCT01457924|BG003|Baseline|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078040|NCT01457924|BG004|Baseline|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078041|NCT01457924|BG005|Baseline|Total|Total of all reporting groups
11078042|NCT01457924|FG000|Participant Flow|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 to Week 20, except on Week 12 participants received 3 milligrams (mg) ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 gram (g) and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078043|NCT01457924|FG001|Participant Flow|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection every 12th week (q12w) on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078044|NCT01457924|FG002|Participant Flow|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078045|NCT01457924|FG003|Participant Flow|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078046|NCT01457924|FG004|Participant Flow|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078047|NCT01457924|OG000|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078048|NCT01457924|OG001|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078049|NCT01457924|OG002|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078050|NCT01457924|OG003|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078051|NCT01457924|OG004|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078052|NCT01457924|EG000|Reported Event|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078053|NCT01457924|EG001|Reported Event|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078054|NCT01457924|EG002|Reported Event|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078055|NCT01457924|EG003|Reported Event|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078056|NCT01457924|EG004|Reported Event|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
11078057|NCT01457950|BG000|Baseline|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
11078058|NCT01457950|BG001|Baseline|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
11078059|NCT01457950|BG002|Baseline|Total|Total of all reporting groups
11078060|NCT01457950|FG000|Participant Flow|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
11078061|NCT01457950|FG001|Participant Flow|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
11173648|NCT02016690|OG000|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
11078062|NCT01457950|FG002|Participant Flow|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
11078063|NCT01457950|FG003|Participant Flow|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
11078064|NCT01457950|OG000|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
11078065|NCT01457950|OG001|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
11078066|NCT01457950|OG000|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
11078067|NCT01457950|OG000|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
11078068|NCT01457950|OG001|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
11078069|NCT01457950|EG000|Reported Event|Randomized Phase: Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
11078070|NCT01457950|EG001|Reported Event|Randomized Phase: Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
11078071|NCT01457950|EG002|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Denosumab)|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
11078072|NCT01457950|EG003|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Placebo)|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
11091884|NCT01536574|OG000|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
11091885|NCT01536574|OG001|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
11150328|NCT01877161|BG000|Baseline|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants.~3 sessions of rTMS were determined by a random sequence (eg. MTG-STG-Sham, Sham-MTG-STG, STG-MTG-Sham etc.) MTG: middle temporal gyrus STG: superior temporal gyrus~The sequence of stimulation was counter-balanced across subjects. different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
11173649|NCT02016690|EG000|Reported Event|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
11078073|NCT01458106|BG000|Baseline|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
11078074|NCT01458106|BG001|Baseline|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
11078075|NCT01458106|BG002|Baseline|Total|Total of all reporting groups
11078076|NCT01458106|FG000|Participant Flow|Participants < 6 Years Old|"Pharmacokinetic (PK) subgroup: After a Washout Period of ≥72 hrs, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5±2 minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for PK assessment. Following a second Washout Period of ≥72 hrs, participants receive a single IV injection of rFVIIIFc over 5±2 mins at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
11078077|NCT01458106|FG001|Participant Flow|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
11078078|NCT01458106|OG000|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
11078079|NCT01458106|OG001|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
11078080|NCT01458106|OG002|Outcome|All Arms: Total|
11227456|NCT02383056|FG000|Participant Flow|Sham Group (Group 1)|"This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes~Omnilux sham light"
11227457|NCT02383056|FG001|Participant Flow|Treatment Group (Group 2)|"This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes~Omnilux: 633nm"
11227458|NCT02383056|OG000|Outcome|Sham Group (Group 1)|"This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes~Omnilux sham light"
11227459|NCT02383056|OG001|Outcome|Treatment Group (Group 2)|"This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes~Omnilux: 633nm"
11078081|NCT01458106|OG000|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
11078082|NCT01458106|OG001|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
11078083|NCT01458106|EG000|Reported Event|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
11078084|NCT01458106|EG001|Reported Event|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
11078085|NCT01458119|BG000|Baseline|Migalastat|Participants received migalastat 150-mg capsule given orally QOD for a median duration of 23.5 m. Participants received an inactive reminder capsule on alternate days during the study.
11078086|NCT01458119|FG000|Participant Flow|Migalastat|Participants received migalastat hydrochloride (migalastat) 150-milligram (mg) capsule (equivalent to 123 mg of migalastat) given orally once every other day (QOD) for a median duration of 23.5 months (m). Participants received an inactive reminder capsule on alternate days during the study.
11078087|NCT01458119|OG000|Outcome|Migalastat|Participants received migalastat 150-mg capsule given orally QOD for a median duration of 23.5 m. Participants received an inactive reminder capsule on alternate days during the study.
11078088|NCT01458119|OG000|Outcome|Migalastat ITT-Amenable Population|"Participants received migalastat 150-mg capsule given orally QOD for a median duration of 23.5 m. Participants received an inactive reminder capsule on alternate days during the study. The ITT-amenable population included all participants who received at least 1 dose of study drug after they enrolled into this open-label extension study. Participants with mutant forms of α-Gal A determined to be amenable to migalastat treatment based on the GLP-HEK assay are referred to as with amenable mutations."
11078089|NCT01458119|EG000|Reported Event|Migalastat|Participants received migalastat 150-mg capsule given orally QOD for a median duration of 23.5 m. Participants received an inactive reminder capsule on alternate days during the study.
11078090|NCT01458132|BG000|Baseline|Participants Without Seizure|Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine ) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
11078091|NCT01458132|BG001|Baseline|Participants With Seizure|Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and experienced seizure during the follow-up period , after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
11078092|NCT01458132|BG002|Baseline|Total|Total of all reporting groups
11078093|NCT01458132|FG000|Participant Flow|Participants Without Seizure|Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 milligram (mg), for atleast four weeks in the Phase 2b trials.
11078094|NCT01458132|FG001|Participant Flow|Participants With Seizure|Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and experienced seizure during the follow-up period , after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
11078095|NCT01458132|OG000|Outcome|Participants Without Seizure|Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
11078096|NCT01458132|OG001|Outcome|Participants With Seizure|Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
11078097|NCT01458132|EG000|Reported Event|Participants Without Seizure|Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
11078098|NCT01458132|EG001|Reported Event|Participants With Seizure|Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
11078099|NCT01458171|BG000|Baseline|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
11078100|NCT01458171|FG000|Participant Flow|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
11078101|NCT01458171|OG000|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
11078102|NCT01458171|OG000|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
11078103|NCT01458171|OG001|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
11078104|NCT01458171|EG000|Reported Event|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
11078105|NCT01458210|BG000|Baseline|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
11078106|NCT01458210|FG000|Participant Flow|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
11078107|NCT01458210|OG000|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
11078108|NCT01458210|OG001|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
11078109|NCT01458210|EG000|Reported Event|Lead-in (1st Course of Ortho-Cyclen)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in).
11078110|NCT01458210|EG001|Reported Event|Ortho-Cyclen Alone|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).
11078111|NCT01458210|EG002|Reported Event|Ortho-Cyclen + Dulaglutide|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
11078112|NCT01458249|BG000|Baseline|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
11227460|NCT02383056|EG000|Reported Event|Sham Group (Group 1)|"This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes~Omnilux sham light"
11078113|NCT01458249|BG001|Baseline|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
11078114|NCT01458249|BG002|Baseline|Total|Total of all reporting groups
11078115|NCT01458249|FG000|Participant Flow|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
11078116|NCT01458249|OG000|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
11078117|NCT01458249|OG001|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
11078118|NCT01458249|EG000|Reported Event|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
11078119|NCT01458275|BG000|Baseline|Placebo|Placebo: Placebo - one actuation per nostril
11078120|NCT01458275|BG001|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
11078121|NCT01458275|BG002|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
11078122|NCT01458275|BG003|Baseline|Total|Total of all reporting groups
11078123|NCT01458275|FG000|Participant Flow|Placebo|Placebo: Placebo - one actuation per nostril
11078124|NCT01458275|FG001|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
11078125|NCT01458275|FG002|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
11078126|NCT01458275|OG000|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
11078127|NCT01458275|OG001|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
11078128|NCT01458275|OG002|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
11078129|NCT01458275|OG000|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
11078130|NCT01458275|OG001|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
11078131|NCT01458275|EG000|Reported Event|Placebo|Placebo: Placebo - one actuation per nostril
11078132|NCT01458275|EG001|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
11078133|NCT01458275|EG002|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
11078134|NCT01458288|BG000|Baseline|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
11078135|NCT01458288|FG000|Participant Flow|TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
11078136|NCT01458288|OG000|Outcome|TG-0054 (3.14 mg/kg)|Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.
11078137|NCT01458288|OG001|Outcome|TG-0054 (3.14 mg/kg)+G-CSF|Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
11078138|NCT01458288|EG000|Reported Event|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
11078139|NCT01458327|BG000|Baseline|3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy|"3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later~MDMA-AT: MDMA-assisted therapy"
11078140|NCT01458327|FG000|Participant Flow|3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy|"3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later~MDMA-AT: MDMA-assisted therapy"
11078141|NCT01458327|OG000|Outcome|3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy|"125 mg and 62.5 mg MDMA and therapy~3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later~Therapy: MDMA-assisted therapy"
11078142|NCT01458327|OG000|Outcome|3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy|"3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later~MDMA-AT: MDMA-assisted therapy"
11078143|NCT01458327|EG000|Reported Event|3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy|"3,4-methylenedioxymethamphetmine (MDMA): 125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later~MDMA-AT: MDMA-assisted therapy"
11078144|NCT01458366|BG000|Baseline|Bendamustine 70 mg/m2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~- Level 1: 70 mg/m2"
11078145|NCT01458366|BG001|Baseline|Bendamustine 50 mg/m2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~- Level -1: 50 mg/m2"
11078146|NCT01458366|BG002|Baseline|Bendamustine 90 mg/m2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~- Level 2: 90 mg/m2"
11078147|NCT01458366|BG003|Baseline|Bendamustine 120 mg/m2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~- Level 3: 120 mg/m2"
11078148|NCT01458366|BG004|Baseline|Bendamustine at MTD|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.~Ofatumumab: Phase II~Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3~Cycles 2 and 3: 1000 mg via IV on Day 1~Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle~Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle"
11078149|NCT01458366|BG005|Baseline|Total|Total of all reporting groups
11078150|NCT01458366|FG000|Participant Flow|Bendamustine 70mg/m^2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine:~- Level 1: 70 mg/m2"
11078151|NCT01458366|FG001|Participant Flow|Bendamustine 50mg/m^2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine:~- Level -1: 50 mg/m2"
11078152|NCT01458366|FG002|Participant Flow|Bendamustin 90mg/m^2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine:~- Level 2: 90 mg/m2"
11078153|NCT01458366|FG003|Participant Flow|Bendamustine 120mg/m^2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine:~- Level 3: 120 mg/m^2"
11078154|NCT01458366|FG004|Participant Flow|Bendamustine at MTD|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine:~Phase II at the MTD"
11078155|NCT01458366|OG000|Outcome|Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~Level 1: 70 mg/m2~Level -1: 50 mg/m2~Level 2: 90 mg/m2~Level 3: 120 mg/m2~Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.~Ofatumumab: Phase II~Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3~Cycles 2 and 3: 1000 mg via IV on Day 1~Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle~Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle"
11078156|NCT01458366|EG000|Reported Event|Bendamustine 70 mg/m2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~- Level 1: 70 mg/m2"
11078157|NCT01458366|EG001|Reported Event|Bendamustine 50 mg/m2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~- Level -1: 50 mg/m2"
11078158|NCT01458366|EG002|Reported Event|Bendamustine 90 mg/m2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~- Level 2: 90 mg/m2"
11078159|NCT01458366|EG003|Reported Event|Bendamustine 120 mg/m2|"Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide~Bendamustine: Phase 1: Given via IV at the following dose levels:~- Level 3: 120 mg/m2"
11078160|NCT01458366|EG004|Reported Event|Bendamustine at MTD|"Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.~Ofatumumab: Phase II~Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3~Cycles 2 and 3: 1000 mg via IV on Day 1~Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle~Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle"
11078161|NCT01458392|BG000|Baseline|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
11078162|NCT01458392|BG001|Baseline|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
11078163|NCT01458392|BG002|Baseline|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
11227461|NCT02383056|EG001|Reported Event|Treatment Group (Group 2)|"This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes~Omnilux: 633nm"
11078164|NCT01458392|BG003|Baseline|Total|Total of all reporting groups
11078165|NCT01458392|FG000|Participant Flow|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
11078166|NCT01458392|FG001|Participant Flow|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
11078167|NCT01458392|FG002|Participant Flow|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
11078168|NCT01458392|OG000|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
11078169|NCT01458392|OG001|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
11078170|NCT01458392|OG000|Outcome|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
11078171|NCT01458392|OG001|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
11078172|NCT01458392|OG002|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
11078173|NCT01458392|OG000|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
11078174|NCT01458392|OG001|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
11078175|NCT01458392|EG000|Reported Event|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
11078176|NCT01458392|EG001|Reported Event|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
11078177|NCT01458392|EG002|Reported Event|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
11078178|NCT01458418|BG000|Baseline|Montelukast 10 mg/Day|"Subjects will receive two 5mg tablets of Montelukast/day.~Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast."
11078179|NCT01458418|BG001|Baseline|Montelukast 5mg/Day|"Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.~5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day."
11078180|NCT01458418|BG002|Baseline|Placebo|"Subjects will receive two placebo tablets per day.~placebo: Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day."
11078181|NCT01458418|BG003|Baseline|Subjects Who Were Not Unblinded so Arm is Unknown|Subjects were never unblinded and no results were reported due to small number of enrolled subjects and lack of amount of data to show any demonstrable differences.
11078182|NCT01458418|BG004|Baseline|Total|Total of all reporting groups
11078183|NCT01458418|FG000|Participant Flow|Montelukast 10 mg/Day|"Subjects will receive two 5mg tablets of Montelukast/day.~Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast."
11078184|NCT01458418|FG001|Participant Flow|Montelukast 5mg/Day|"Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.~5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day."
11078185|NCT01458418|FG002|Participant Flow|Placebo|"Subjects will receive two placebo tablets per day.~placebo: Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day."
11078186|NCT01458418|FG003|Participant Flow|Subjects Who Were Not Unblinded so Arm is Unknown|Subjects were never unblinded and no results were reported due to small number of enrolled subjects and lack of amount of data to show any demonstrable differences.
11078187|NCT01458418|OG000|Outcome|Montelukast 10 mg/Day|"Subjects will receive two 5mg tablets of Montelukast/day.~Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast."
11078188|NCT01458418|OG001|Outcome|Montelukast 5mg/Day|"Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.~5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day."
11078189|NCT01458418|OG002|Outcome|Placebo|"Subjects will receive two placebo tablets per day.~placebo: Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day."
11078190|NCT01458418|OG003|Outcome|Subjects Whose Arm is Unknown Due to Not Being Unblinded|subjects were never unblinded as data was never analyzed due to too few subjects to create generalizable knowledge.
11078191|NCT01458418|EG000|Reported Event|Montelukast 10 mg/Day|"Subjects will receive two 5mg tablets of Montelukast/day.~Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast."
11078192|NCT01458418|EG001|Reported Event|Montelukast 5mg/Day|"Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.~5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day."
11078193|NCT01458418|EG002|Reported Event|Placebo|"Subjects will receive two placebo tablets per day.~placebo: Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day."
11078194|NCT01458418|EG003|Reported Event|Subjects Who Were Not Unblinded so Arm is Unknown|Subjects were never unblinded and no results were reported due to small number of enrolled subjects and lack of amount of data to show any demonstrable differences.
11078195|NCT01458522|BG000|Baseline|LCM First, Then fPHT|"LCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.~If after initial treatment and any of the following occurs, subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period."
11078196|NCT01458522|BG001|Baseline|fPHT First, Then LCM|"fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.~If after initial treatment and any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary)."
11078197|NCT01458522|BG002|Baseline|Total|Total of all reporting groups
11078198|NCT01458522|FG000|Participant Flow|LCM First, Then fPHT|"LCM bolus of 400 mg administered over 30 minutes. If further bolus is required, 200 mg is administered. Regardless of whether the subject received a rebolus, they will begin receiving a maintenance dose 12 hrs after initial dose. Daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.~If after initial treatment and any of the following occurs, subject will have reached end of 1st treatment arm and will crossover and receive the other drug. If any of the following did not occur the subject will be considered completed.~Subject has another seizure within 24 hrs following the 2-hr post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hrs following 2-hr post bolus observation-only period.~Subject experiences an AE that precludes further use of the 1st study drug. If crossover occurs, the subject will start over with the second drug, going through the same observation-only period."
11078199|NCT01458522|FG001|Participant Flow|fPHT First, Then LCM|"fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.~If after initial treatment and any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug. If any of the following did NOT occur the subject will be considered completed.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary)."
11078200|NCT01458522|OG000|Outcome|LCM 400mg|LCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.
11078201|NCT01458522|OG001|Outcome|fPHT 20mg PE/kg|fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.
11078202|NCT01458522|OG000|Outcome|LCM First, Then fPHT|"LCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.~If after initial treatment and any of the following occurs, subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period."
11078203|NCT01458522|OG001|Outcome|fPHT First, Then LCM|"fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.~If after initial treatment and any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary)."
11078204|NCT01458522|OG000|Outcome|LCM First, Then fPHT|"LCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.~If after initial treatment and any of the following occurs, subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug. If crossover occurs, the subject will start over with the second drug, going through the same observation-only period."
11078205|NCT01458522|OG001|Outcome|fPHT First, Then LCM|"fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.~If after initial treatment and any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug. If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary)."
11078206|NCT01458522|OG000|Outcome|LCM Treatment|"LCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.~If after initial treatment and any of the following occurs, subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period."
11078207|NCT01458522|OG001|Outcome|fPHT Treatment|"fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.~If after initial treatment and any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.~Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.~Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.~Subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary)."
11078208|NCT01458522|EG000|Reported Event|All Participants Receiving LCM 400mg|Participants who receive a bolus of 400mg administered over 30 minutes. If a further bolus is required, 200mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400mg or 600mg) divided into 2 doses.
11078209|NCT01458522|EG001|Reported Event|All Participants Receiving fPHT 20mg PE/kg|Participants who receive a bolus of 20mg PE/kg administered at a rate no greater than 75mg PE/minute. If a further bolus is required, 5mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5mg PE/kg divided into 2 doses.
11078210|NCT01458535|BG000|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
11078211|NCT01458535|BG001|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
11078212|NCT01458535|BG002|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
11078213|NCT01458535|BG003|Baseline|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
11078214|NCT01458535|BG004|Baseline|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
11078215|NCT01458535|BG005|Baseline|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
11078216|NCT01458535|BG006|Baseline|Total|Total of all reporting groups
11078217|NCT01458535|FG000|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve genotype 1 participants.
11078218|NCT01458535|FG001|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
11078219|NCT01458535|FG002|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
11078220|NCT01458535|FG003|Participant Flow|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
11078221|NCT01458535|FG004|Participant Flow|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
11078222|NCT01458535|FG005|Participant Flow|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
11078223|NCT01458535|OG000|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
11078224|NCT01458535|OG001|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
11078225|NCT01458535|OG002|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
11078226|NCT01458535|OG003|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
11078227|NCT01458535|OG004|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
11078228|NCT01458535|OG005|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
11078229|NCT01458535|EG000|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
11078230|NCT01458535|EG001|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
11078231|NCT01458535|EG002|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
11078232|NCT01458535|EG003|Reported Event|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
11078233|NCT01458535|EG004|Reported Event|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
11078234|NCT01458535|EG005|Reported Event|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
11078235|NCT01458561|BG000|Baseline|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078236|NCT01458561|BG001|Baseline|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078237|NCT01458561|BG002|Baseline|Total|Total of all reporting groups
11078238|NCT01458561|FG000|Participant Flow|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078239|NCT01458561|FG001|Participant Flow|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078240|NCT01458561|OG000|Outcome|Control Bleeding in BioFoam Subjects/Participants|"Control of bleeding in subjects/participants who receive BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078241|NCT01458561|OG001|Outcome|Control Bleeding in Gelfoam Plus Subjects/Participants|"Control of bleeding in subjects/participants who receive Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078242|NCT01458561|OG000|Outcome|Subjects/Participants Receiving BioFoam|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078243|NCT01458561|OG001|Outcome|Subjects/Participants Receiving Gelfoam Plus|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078244|NCT01458561|OG000|Outcome|Achieve Immediate Hemostasis in BioFoam Subjects/Participants|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078245|NCT01458561|OG001|Outcome|Achievement of Immediate Hemostasis in Gelfoam Plus Subjects|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078246|NCT01458561|OG000|Outcome|Intraop. Blood Loss in BioFoam Surgical Matrix Subjects|"Amount of blood lost intraoperatively in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078247|NCT01458561|OG001|Outcome|Intraop. Blood Loss in Gelfoam Plus Subjects|"Amount of blood lost intraoperatively in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078248|NCT01458561|OG000|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078249|NCT01458561|OG001|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078250|NCT01458561|OG000|Outcome|Duration of Postoperative Drainage in BioFoam Subjects|"Duration of postoperative drainage in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078251|NCT01458561|OG001|Outcome|Duration of Postoperative Drainage in Gelfoam Plus Subjects|"Duration of postoperative drainage in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078252|NCT01458561|OG000|Outcome|Amt. of Intraop. Blood Products Rec'd by BioFoam Subjects|"Amount of blood products administered intraoperatively to subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078253|NCT01458561|OG001|Outcome|Amt. of Intraop. Blood Products Rec'd by Gelfoam Plus Subjects|"Amount of blood products administered intraoperatively to subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078254|NCT01458561|OG000|Outcome|Laboratory Evaluations for BioFoam Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078255|NCT01458561|OG001|Outcome|Laboratory Evaluations for Gelfoam Plus Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078256|NCT01458561|OG000|Outcome|Presence of Device Via MRI in BioFoam Surgical Matrix Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078257|NCT01458561|OG001|Outcome|Presence of Device Via MRI in Gelfoam Plus Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078258|NCT01458561|OG000|Outcome|BioFoam Subj. Requiring Reop. Due to Bleeding/Biliary Leakage|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078259|NCT01458561|OG001|Outcome|Gelfoam Plus Subj. Requiring Reop. Due to Bleeding/Bili. Leak|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078260|NCT01458561|OG000|Outcome|Total Time of Procedure for BioFoam Surgical Matrix Subjects|"Total time of procedure for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078261|NCT01458561|OG001|Outcome|Total Time of Procedure for Gelfoam Plus Subjects|"Total time of procedure for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078262|NCT01458561|OG000|Outcome|Core Body Temp of BioFoam Subjects During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078263|NCT01458561|OG001|Outcome|Core Body Temp of Gelfoam Plus During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078264|NCT01458561|OG000|Outcome|Length of Hospital Stay for BioFoam Surgical Matrix Subjects|"Length of hospital stay for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078265|NCT01458561|OG001|Outcome|Length of Hospital Stay for Gelfoam Plus Subjects|"Length of hospital stay for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078266|NCT01458561|OG000|Outcome|# of BioFoam Subjects Requiring Hospitalization/Intervention|"Number of subjects receiving BioFoam Surgical Matrix as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078267|NCT01458561|OG001|Outcome|# of Gelfoam Plus Subj. Requiring Hospitalization/Intervention|"Number of subjects receiving Gelfoam Plus as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078268|NCT01458561|OG000|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titers in BioFoam Subj|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078269|NCT01458561|OG001|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titer in Gelfoam Plus Sub|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078270|NCT01458561|OG000|Outcome|Complications/Adverse Events in Subjects Receiving BioFoam|"Number of complications/adverse events recorded for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078271|NCT01458561|OG001|Outcome|Complications/Adverse Events in Subj. Receiving Gelfoam Plus|"Number of complications/adverse events recorded for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078272|NCT01458561|EG000|Reported Event|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
11078273|NCT01458561|EG001|Reported Event|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
11078274|NCT01458574|BG000|Baseline|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078275|NCT01458574|BG001|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078276|NCT01458574|BG002|Baseline|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078277|NCT01458574|BG003|Baseline|Total|Total of all reporting groups
11078278|NCT01458574|FG000|Participant Flow|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078279|NCT01458574|FG001|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078280|NCT01458574|FG002|Participant Flow|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078281|NCT01458574|OG000|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078282|NCT01458574|OG001|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078283|NCT01458574|OG002|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078284|NCT01458574|EG000|Reported Event|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078285|NCT01458574|EG001|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078286|NCT01458574|EG002|Reported Event|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
11078287|NCT01458587|BG000|Baseline|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
11078288|NCT01458587|BG001|Baseline|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
11078289|NCT01458587|BG002|Baseline|Total|Total of all reporting groups
11078290|NCT01458587|FG000|Participant Flow|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
11078291|NCT01458587|FG001|Participant Flow|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
11078292|NCT01458587|OG000|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
11078293|NCT01458587|OG001|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
11078294|NCT01458587|OG002|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
11078295|NCT01458587|OG003|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
11078296|NCT01458587|EG000|Reported Event|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
11078297|NCT01458587|EG001|Reported Event|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
11078298|NCT01458639|BG000|Baseline|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
11078299|NCT01458639|FG000|Participant Flow|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
11078300|NCT01458639|OG000|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
11078301|NCT01458639|EG000|Reported Event|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
11078302|NCT01458951|BG000|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
11078303|NCT01458951|BG001|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
11078304|NCT01458951|BG002|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
11078305|NCT01458951|BG003|Baseline|Total|Total of all reporting groups
11078306|NCT01458951|FG000|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
11078307|NCT01458951|FG001|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
11078308|NCT01458951|FG002|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
11078309|NCT01458951|OG000|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
11078310|NCT01458951|OG001|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
11078311|NCT01458951|EG000|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
11078312|NCT01458951|EG001|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
11078313|NCT01458951|EG002|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
11078314|NCT01458990|BG000|Baseline|PPI Inititation|Adding 40mg omeprazole QD for 14 days
11078315|NCT01458990|BG001|Baseline|PPI Withdrawal|The intervention here is systematically withdrawing chronic PPI for 14 days
11078316|NCT01458990|BG002|Baseline|Total|Total of all reporting groups
11078317|NCT01458990|FG000|Participant Flow|PPI Inititation|Adding 40mg omeprazole QD for 14 days
11078318|NCT01458990|FG001|Participant Flow|PPI Withdrawal|The intervention here is systematically withdrawing chronic PPI for 14 days
11078319|NCT01458990|OG000|Outcome|PPI Inititation|"Adding 40mg omeprazole QD for 14 days~Omeprazole: 20mg PO BID for 20 days"
11078320|NCT01458990|OG001|Outcome|PPI Withdrawal|"The intervention here is systematically withdrawing chronic PPI for 14 days~Omeprazole: 20mg PO BID for 20 days"
11078321|NCT01458990|OG000|Outcome|PPI Initiation|No safety signals were identified
11078322|NCT01458990|OG001|Outcome|PPI Withdrawal|No safety signals were identified
11078323|NCT01458990|EG000|Reported Event|PPI Inititation|Adding 40mg omeprazole QD for 14 days
11078324|NCT01458990|EG001|Reported Event|PPI Withdrawal|The intervention here is systematically withdrawing chronic PPI for 14 days
11078325|NCT01459016|BG000|Baseline|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
11078326|NCT01459016|FG000|Participant Flow|Standard of Care|Participants with prodromal to mild Alzheimer's Disease (AD) underwent a florbetapir F 18 positron emission tomography (PET) scan. (Single intravenous microdose of 260 to 370 megabecquerels (MBq) [7 to 10 millicuries (mCi)] of florbetapir.) Those who tested amyloid positive and met other entry criteria received standard of care for up to 12 months (mos). No therapeutic investigational drug intended to treat AD was administered.
11078327|NCT01459016|OG000|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
11078328|NCT01459016|EG000|Reported Event|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
11078329|NCT01459068|BG000|Baseline|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
11078330|NCT01459068|BG001|Baseline|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
11078331|NCT01459068|BG002|Baseline|Total|Total of all reporting groups
11078332|NCT01459068|FG000|Participant Flow|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
11173650|NCT02016716|BG000|Baseline|Placebo|Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.
11173651|NCT02016716|BG001|Baseline|Romosozumab 70 mg/mL|Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.
11078333|NCT01459068|FG001|Participant Flow|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
11078334|NCT01459068|OG000|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
11078335|NCT01459068|OG001|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
11078336|NCT01459068|EG000|Reported Event|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
11078337|NCT01459068|EG001|Reported Event|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
11078338|NCT01459588|BG000|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
11078339|NCT01459588|BG001|Baseline|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11349124|NCT04117607|FG008|Participant Flow|MAD2|"60 mg (1 injection of 0.6 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11078340|NCT01459588|BG002|Baseline|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11078341|NCT01459588|BG003|Baseline|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
11078342|NCT01459588|BG004|Baseline|Total|Total of all reporting groups
11078343|NCT01459588|FG000|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
11078344|NCT01459588|FG001|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11078345|NCT01459588|FG002|Participant Flow|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11078346|NCT01459588|FG003|Participant Flow|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
11078347|NCT01459588|OG000|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
11078348|NCT01459588|OG001|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11078349|NCT01459588|OG002|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11078350|NCT01459588|OG003|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
11078351|NCT01459588|EG000|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
11078352|NCT01459588|EG001|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11078353|NCT01459588|EG002|Reported Event|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11078354|NCT01459588|EG003|Reported Event|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
11078355|NCT01459614|BG000|Baseline|Primary Cohort (21 Day Cycle)|Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
11078356|NCT01459614|BG001|Baseline|Expansion Cohort (28 Day Cycle)|Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
11078357|NCT01459614|BG002|Baseline|Total|Total of all reporting groups
11078358|NCT01459614|FG000|Participant Flow|Primary Cohort (21 Day Cycle)|Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
11078359|NCT01459614|FG001|Participant Flow|Expansion Cohort (28 Day Cycle)|Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
11078360|NCT01459614|OG000|Outcome|Primary Cohort (21 Day Cycle)|Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
11078361|NCT01459614|OG001|Outcome|Expansion Cohort (28 Day Cycle)|Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
11078362|NCT01459614|EG000|Reported Event|Primary Cohort (21 Day Cycle)|Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
11078363|NCT01459614|EG001|Reported Event|Expansion Cohort (28 Day Cycle)|Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
11078364|NCT01459653|BG000|Baseline|EP2006, Evaluable Sample|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Only patients who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) belong to the evaluable sample and are analyzed.
11078365|NCT01459653|FG000|Participant Flow|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078366|NCT01459653|OG000|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078367|NCT01459653|OG000|Outcome|EP2006: Male|Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078368|NCT01459653|OG001|Outcome|EP2006: Female|Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078369|NCT01459653|OG000|Outcome|EP2006: <65 Years|Cancer patients <65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078370|NCT01459653|OG001|Outcome|EP2006: >=65 Years|Cancer patients >=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078371|NCT01459653|OG000|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078372|NCT01459653|OG001|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078373|NCT01459653|OG000|Outcome|EP2006: <=65kg|Cancer patients weighing <=65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078374|NCT01459653|OG001|Outcome|EP2006: >65kg|Cancer patients weighing >65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078375|NCT01459653|OG000|Outcome|EP2006: Risk <10%|Cancer patients with chemotherapy toxicity <10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078376|NCT01459653|OG001|Outcome|EP2006: Risk 10-20%|Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078377|NCT01459653|OG002|Outcome|EP2006: Risk >20%|Cancer patients with chemotherapy toxicity >20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078378|NCT01459653|OG000|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
11078379|NCT01459653|OG001|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
11078380|NCT01459653|OG000|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078381|NCT01459653|OG001|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078382|NCT01459653|OG002|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078383|NCT01459653|OG001|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
11078384|NCT01459653|OG000|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078385|NCT01459653|OG001|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078386|NCT01459653|OG000|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).
11078387|NCT01459653|OG001|Outcome|EP2006 - Solid Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).
11078388|NCT01459653|OG002|Outcome|EP2006 - Hematological Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
11078389|NCT01459653|OG000|Outcome|EP2006, >20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (>20% chemo-associated FN risk)
11078390|NCT01459653|OG001|Outcome|EP2006, 10-20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (10-20% chemo-associated FN risk).
11078391|NCT01459653|OG002|Outcome|EP2006, <10% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (<10% chemo-associated FN risk).
11078392|NCT01459653|OG000|Outcome|EP2006: All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078393|NCT01459653|OG001|Outcome|EP2006: Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078394|NCT01459653|OG002|Outcome|EP2006: Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078395|NCT01459653|OG000|Outcome|EP2006: EP2006 Initiation During Chemotherapy (Day 0)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0).
11078396|NCT01459653|OG001|Outcome|EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP 2006 initiation per guidelines (days 1-3).
11078397|NCT01459653|OG002|Outcome|EP2006: EP2006 Initiation Later (Day 4 or More)^|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation later (day 4 or more).
11078398|NCT01459653|OG000|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078399|NCT01459653|OG001|Outcome|EP2006 - Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078400|NCT01459653|OG002|Outcome|EP2006 - Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078401|NCT01459653|OG000|Outcome|EP2006 Cycles|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078402|NCT01459653|OG000|Outcome|EP2006 Cycle Level|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078403|NCT01459653|OG000|Outcome|EP2006: Low (<10%) Risk|Cancer patients treated with chemotherapy with low risk(<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078404|NCT01459653|OG001|Outcome|EP2006: Medium (10-20%) Risk|Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078405|NCT01459653|OG002|Outcome|EP2006: High (>20%) Risk|Cancer patients treated with chemotherapy with high risk(>20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078406|NCT01459653|OG000|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN
11233731|NCT02430870|OG001|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11078407|NCT01459653|OG001|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
11078408|NCT01459653|OG000|Outcome|EP2006: Undertreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines
11078409|NCT01459653|OG001|Outcome|EP2006: Correctly Treated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, correctly treated relative to guidelines
11078410|NCT01459653|OG002|Outcome|EP2006: Overtreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, overtreated relative to guidelines.
11078411|NCT01459653|OG000|Outcome|EP2006: 30MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 30MIU/day
11078412|NCT01459653|OG001|Outcome|EP2006: 48MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day
11078413|NCT01459653|OG000|Outcome|EP2006: Mean GIS 0-0.5|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5
11078414|NCT01459653|OG001|Outcome|EP2006: Mean GIS 0.51-0.99|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99
11078415|NCT01459653|OG002|Outcome|EP2006: Mean GIS 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1
11078416|NCT01459653|OG000|Outcome|EP2006: Day 0 (During Chemotherapy)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)
11078417|NCT01459653|OG001|Outcome|EP2006: Days 1-3 (Per Guidelines)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on days 1-3 (per guidelines)
11078418|NCT01459653|OG002|Outcome|EP2006: Day 4 or Later|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later
11078419|NCT01459653|OG000|Outcome|EP2006: 1-3 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration.
11078420|NCT01459653|OG001|Outcome|EP2006: 4-5 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 4-5 days of study drug duration.
11078421|NCT01459653|OG002|Outcome|EP2006: >=6 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with >=6 days of study drug duration.
11078422|NCT01459653|OG000|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078423|NCT01459653|OG001|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078424|NCT01459653|OG000|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients having any CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078425|NCT01459653|OG001|Outcome|EP2006: no CIN/FN-related Chemotherapy Disturbance|Cancer patients having no CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078426|NCT01459653|OG000|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with any grade 4 CIN/FN
11078427|NCT01459653|OG001|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with no grade 4 CIN/FN
11078428|NCT01459653|OG000|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had any CIN/FN-related chemotherapy disturbance
11078429|NCT01459653|OG001|Outcome|EP2006: No CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance
11078430|NCT01459653|OG000|Outcome|EP2006: Undertreated|Undertreated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078431|NCT01459653|OG001|Outcome|EP2006: Correctly Treated|Correctly treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078432|NCT01459653|OG002|Outcome|EP2006: Over Treated|Over treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
11078433|NCT01459653|OG000|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
11078434|NCT01459653|EG000|Reported Event|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.
11078435|NCT01459705|BG000|Baseline|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
11078436|NCT01459705|BG001|Baseline|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
11173652|NCT02016716|BG002|Baseline|Romosozumab 90 mg/mL|Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
11078437|NCT01459705|BG002|Baseline|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
11078438|NCT01459705|BG003|Baseline|Total|Total of all reporting groups
11078439|NCT01459705|FG000|Participant Flow|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
11078440|NCT01459705|FG001|Participant Flow|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
11078441|NCT01459705|FG002|Participant Flow|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
11078442|NCT01459705|OG000|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
11078443|NCT01459705|OG001|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
11078444|NCT01459705|OG002|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
11078445|NCT01459705|EG000|Reported Event|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
11078446|NCT01459705|EG001|Reported Event|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
11078447|NCT01459705|EG002|Reported Event|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
11078448|NCT01459718|BG000|Baseline|Deferasirox / Deferasirox + Deferoxamine (DFO)|During Phase A, the induction treatment at entry, participants received Deferasirox -DFO combination. During Phase B, when participants transitioned to less intensive chelation therapy, participants received Deferasirox monotherapy.
11078449|NCT01459718|FG000|Participant Flow|Deferasirox / Deferasirox + Deferoxamine (DFO)|During Phase A, the induction treatment at entry, participants received Deferasirox -DFO combination. During Phase B, when participants transitioned to less intensive chelation therapy, participants received Deferasirox monotherapy.
11078450|NCT01459718|OG000|Outcome|Deferasirox / Deferasirox + Deferoxamine (DFO)|During Phase A, the induction treatment at entry, participants received Deferasirox -DFO combination. During Phase B, when participants transitioned to less intensive chelation therapy, participants received Deferasirox monotherapy.
11078451|NCT01459718|EG000|Reported Event|Deferasirox / Deferasirox + Deferoxamine (DFO)|During Phase A, the induction treatment at entry, participants received Deferasirox -DFO combination. During Phase B, when participants transitioned to less intensive chelation therapy, participants received Deferasirox monotherapy.
11078452|NCT01459783|BG000|Baseline|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
11173653|NCT02016716|BG003|Baseline|Total|Total of all reporting groups
11078453|NCT01459783|BG001|Baseline|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
11078454|NCT01459783|BG002|Baseline|Total|Total of all reporting groups
11078455|NCT01459783|FG000|Participant Flow|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
11078456|NCT01459783|FG001|Participant Flow|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
11078457|NCT01459783|OG000|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
11078458|NCT01459783|OG001|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
11078459|NCT01459783|EG000|Reported Event|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
11150329|NCT01877161|FG000|Participant Flow|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants 3 sessions of rTMS were determined by a random sequence (eg. middle temporal gyrus (MTG)-superior temporal gyrus (STG)-Sham, Sham-MTG-STG, STG-MTG-Sham etc..0) The sequence of stimulation was counter-balanced across subjects.~different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
11150330|NCT01877161|OG000|Outcome|rTMS Over MTG|Repetitive magnetic stimulation (rTMS) were applied over MTG
11150331|NCT01877161|OG001|Outcome|rTMS Over STG|Repetitive magnetic stimulation (rTMS) were applied over STG
11150332|NCT01877161|OG002|Outcome|Sham rTMS|The coil was placed perpendicularly to the scalp during sham rTMS sessions.
11078460|NCT01459783|EG001|Reported Event|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
11078461|NCT01459796|BG000|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
11078462|NCT01459796|BG001|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
11078463|NCT01459796|BG002|Baseline|Total|Total of all reporting groups
11078464|NCT01459796|FG000|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51.
11078465|NCT01459796|FG001|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
11078466|NCT01459796|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
11078467|NCT01459796|OG001|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
11078468|NCT01459796|EG000|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
11078469|NCT01459796|EG001|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
11349125|NCT04117607|FG009|Participant Flow|MAD3|"100 mg (1 injection of 1.0 mL) of Rezafungin administered subcutaneously into the abdomen as as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11078470|NCT01459913|BG000|Baseline|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
11078471|NCT01459913|BG001|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
11078472|NCT01459913|BG002|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
11078473|NCT01459913|BG003|Baseline|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
11078474|NCT01459913|BG004|Baseline|Total|Total of all reporting groups
11078475|NCT01459913|FG000|Participant Flow|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
11078476|NCT01459913|FG001|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
11150333|NCT01877161|EG000|Reported Event|Middle Temporal Gyrus|"Repetitive magnetic stimulation to middle temporal gyrus~Repetitive magnetic stimulation to middle temporal gyrus: Repetitive magnetic stimulation to middle temporal gyrus"
11150334|NCT01877161|EG001|Reported Event|Control Group|"Repetitive magnetic stimulation (Sham)~Repetitive magnetic stimulation (Sham): Repetitive magnetic stimulation (Sham)"
11078477|NCT01459913|FG002|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
11078478|NCT01459913|FG003|Participant Flow|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
11078479|NCT01459913|OG000|Outcome|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
11078480|NCT01459913|OG001|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
11078481|NCT01459913|OG000|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
11078482|NCT01459913|OG002|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
11078483|NCT01459913|OG003|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
11078484|NCT01459913|OG004|Outcome|Telaprevir+Peg-IFN-alfa-2a, RBV (Total)|All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, up to 48 weeks.
11078485|NCT01459913|EG000|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
11078486|NCT01459913|EG001|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
11078487|NCT01459913|EG002|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
11078488|NCT01459913|EG003|Reported Event|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
11078489|NCT01460225|BG000|Baseline|Lubirprostone|
11078490|NCT01460225|FG000|Participant Flow|Lubirprostone|
11078491|NCT01460225|OG000|Outcome|Prior to Treatement With Lubiprostone|
11078492|NCT01460225|OG001|Outcome|Post Treatment With Lubiprostone|
11078493|NCT01460225|EG000|Reported Event|All- Single Arm|
11150335|NCT01877161|EG002|Reported Event|Superior Temporal Gyrus|"Repetitive magnetic stimulation to superior temporal gyrus~Repetitive magnetic stimulation to superior temporal gyrus: Repetitive magnetic stimulation to superior temporal gyrus"
11227462|NCT02383173|BG000|Baseline|Basic Implementation Approach|"Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams~Basic Implementation Approach: Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using a Basic Implementation Approach with a teleconference to review educational materials and activate PCCTs to educate other providers."
11227463|NCT02383173|BG001|Baseline|Enhanced Implementation Approach|"Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams~Enhanced Implementation Approach: Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using an Enhanced Implementation Approach with in-person, train-the-champion workshops to prepare PCCT members to be leaders and trainers at their home sites"
11227464|NCT02383173|BG002|Baseline|Total|Total of all reporting groups
11227465|NCT02383173|FG000|Participant Flow|Basic Implementation Approach|"Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams~Basic Implementation Approach: Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using a Basic Implementation Approach with a teleconference to review educational materials and activate PCCTs to educate other providers."
11227466|NCT02383173|FG001|Participant Flow|Enhanced Implementation Approach|"Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams~Enhanced Implementation Approach: Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using an Enhanced Implementation Approach with in-person, train-the-champion workshops to prepare PCCT members to be leaders and trainers at their home sites"
11227467|NCT02383173|OG000|Outcome|Basic Implementation Approach|"Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams~Basic Implementation Approach: Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using a Basic Implementation Approach with a teleconference to review educational materials and activate PCCTs to educate other providers."
11227468|NCT02383173|OG001|Outcome|Enhanced Implementation Approach|"Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams~Enhanced Implementation Approach: Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using an Enhanced Implementation Approach with in-person, train-the-champion workshops to prepare PCCT members to be leaders and trainers at their home sites"
11227469|NCT02383173|EG000|Reported Event|Basic Implementation Approach|"Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams~Basic Implementation Approach: Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using a Basic Implementation Approach with a teleconference to review educational materials and activate PCCTs to educate other providers."
11227470|NCT02383173|EG001|Reported Event|Enhanced Implementation Approach|"Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams~Enhanced Implementation Approach: Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using an Enhanced Implementation Approach with in-person, train-the-champion workshops to prepare PCCT members to be leaders and trainers at their home sites"
11227471|NCT02383355|BG000|Baseline|Switch Group|"Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy for 10 weeks~Raltegravir: Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy"
11227472|NCT02383355|BG001|Baseline|Continuation Group|"Individuals in the continuation group will continue the regimen, which consists of antiretroviral therapy as indicated in the inclusion criteria~Continuation of own regimen: Continuation of own antiretroviral medication during the 10 weeks follow-up"
11227473|NCT02383355|BG002|Baseline|Total|Total of all reporting groups
11227474|NCT02383355|FG000|Participant Flow|Switch Group|"Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy for 10 weeks~Raltegravir: Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy"
11227475|NCT02383355|FG001|Participant Flow|Continuation Group|"Individuals in the continuation group will continue the regimen, which consists of antiretroviral therapy as indicated in the inclusion criteria~Continuation of own regimen: Continuation of own antiretroviral medication during the 10 weeks follow-up"
11227476|NCT02383355|OG000|Outcome|Switch Group|"Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy for 10 weeks~Raltegravir: Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy"
11227477|NCT02383355|OG001|Outcome|Continuation Group|"Individuals in the continuation group will continue the regimen, which consists of antiretroviral therapy as indicated in the inclusion criteria~Continuation of own regimen: Continuation of own antiretroviral medication during the 10 weeks follow-up"
11227478|NCT02383355|EG000|Reported Event|Switch Group|"Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy for 10 weeks~Raltegravir: Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy"
11227479|NCT02383355|EG001|Reported Event|Continuation Group|"Individuals in the continuation group will continue the regimen, which consists of antiretroviral therapy as indicated in the inclusion criteria~Continuation of own regimen: Continuation of own antiretroviral medication during the 10 weeks follow-up"
11227480|NCT02383420|BG000|Baseline|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
11227481|NCT02383420|BG001|Baseline|Predicate & Invest.-CsI|Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
11227482|NCT02383420|BG002|Baseline|Predicate & Invest.-Cadavers GOS & CsI|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
11078494|NCT01460290|BG000|Baseline|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg/day and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study."
11078495|NCT01460290|FG000|Participant Flow|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
11078496|NCT01460290|OG000|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
11078497|NCT01460290|OG000|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
11227483|NCT02383420|BG003|Baseline|Total|Total of all reporting groups
11078498|NCT01460290|EG000|Reported Event|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
11078499|NCT01460303|BG000|Baseline|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
11078500|NCT01460303|BG001|Baseline|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
11078501|NCT01460303|BG002|Baseline|Total|Total of all reporting groups
11078502|NCT01460303|FG000|Participant Flow|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
11078503|NCT01460303|FG001|Participant Flow|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
11078504|NCT01460303|OG000|Outcome|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
11078505|NCT01460303|OG001|Outcome|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
11078506|NCT01460303|EG000|Reported Event|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
11078507|NCT01460303|EG001|Reported Event|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
11227484|NCT02383420|FG000|Participant Flow|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
11078508|NCT01460342|BG000|Baseline|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
11078509|NCT01460342|BG001|Baseline|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
11078510|NCT01460342|BG002|Baseline|Total|Total of all reporting groups
11078511|NCT01460342|FG000|Participant Flow|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
11078512|NCT01460342|FG001|Participant Flow|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
11078513|NCT01460342|OG000|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
11078514|NCT01460342|OG001|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
11078515|NCT01460342|EG000|Reported Event|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
11078516|NCT01460342|EG001|Reported Event|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
11078517|NCT01460368|BG000|Baseline|Part A|A single dose of 300 milligrams (mg) LY2409021 administered orally on Day 1. Participants enrolled in Part A were not allowed to participate in Part B.
11078518|NCT01460368|BG001|Baseline|Part B|Participants received a single dose of either 300 milligrams (mg) LY2409021, 400 mg Moxifloxacin, or Placebo on Day 1 in 1 of 3 Study Periods so that after the completion of the 3 study periods, each participant received a single dose of each drug.
11078519|NCT01460368|BG002|Baseline|Total|Total of all reporting groups
11150336|NCT01877187|BG000|Baseline|Lipiodol|"Lipiodol, 10cc per TACE.~Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s)."
11078520|NCT01460368|FG000|Participant Flow|Part A: LY2409021|Participants received 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally to determine the effects of a meal on electrocardiogram (ECG) activity. Participants enrolled in Part A were not allowed to participate in Part B.
11078521|NCT01460368|FG001|Participant Flow|Part B: LY2409021, Placebo, Moxifloxacin|"Period 1: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.~Period 2: Placebo administered orally as a single dose on Day 1.~Period 3: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1."
11078522|NCT01460368|FG002|Participant Flow|Part B: Moxifloxacin, LY2409021, Placebo|"Period 1: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.~Period 2: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.~Period 3: Placebo administered orally as a single dose on Day 1."
11078523|NCT01460368|FG003|Participant Flow|Part B: Placebo, Moxifloxacin, LY2409021|"Period 1: Placebo administered orally as a single dose on Day 1.~Period 2: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.~Period 3: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1."
11078524|NCT01460368|FG004|Participant Flow|Part B: Moxifloxacin, Placebo, LY2409021|"Period 1: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.~Period 2: Placebo administered orally as a single dose on Day 1.~Period 3: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1."
11078525|NCT01460368|FG005|Participant Flow|Part B: Placebo, LY2409021, Moxifloxacin|"Period 1: Placebo administered orally as a single dose on Day 1.~Period 2: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.~Period 3: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1."
11078526|NCT01460368|FG006|Participant Flow|Part B: LY2409021, Moxifloxacin, Placebo|"Period 1: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.~Period 2: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.~Period 3: Placebo administered orally as a single dose on Day 1."
11078527|NCT01460368|OG000|Outcome|Part B: LY2409021|300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period.
11078528|NCT01460368|OG001|Outcome|Part B: Placebo|Placebo: Administered orally as a single dose on Day 1 of the relevant treatment period.
11078529|NCT01460368|OG000|Outcome|Part B: Moxifloxacin|400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period.
11078530|NCT01460368|EG000|Reported Event|Part A: LY2409021|A single dose of 300 milligrams (mg) LY2409021 administered orally on Day 1. Participants enrolled in Part A were not allowed to participate in Part B.
11078531|NCT01460368|EG001|Reported Event|Part B: Placebo|Administered orally as a single dose on Day 1 of the relevant treatment period.
11078532|NCT01460368|EG002|Reported Event|Part B: Moxifloxacin|400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period.
11078533|NCT01460368|EG003|Reported Event|Part B: LY2409021|300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period.
11078534|NCT01460381|BG000|Baseline|LY2216684 + Quinidine (CYP2C19 Poor Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 poor metabolizer (PM) phenotype, as determined by genotyping analysis.~Period 1 (Days 1-7): a single, oral dose of 18 mg LY2216684 was administered on Day 1.~Period 2 (Days 8-15): 300 mg quinidine sulfate controlled release was administered orally, once daily on Days 8-15. Additionally, a single, oral dose of 18 mg LY2216684 was administered on Day 11."
11078535|NCT01460381|BG001|Baseline|LY2216684 (CYP2C19 Extensive Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 extensive metabolizer (EM) phenotype, as determined by genotyping analysis.~Period 1 (Days 1-7): a single, oral dose of 18 mg LY2216684 administered on Day 1.~Period 2 (Days 8-15): EM participants did not participate in this period."
11078536|NCT01460381|BG002|Baseline|Total|Total of all reporting groups
11078537|NCT01460381|FG000|Participant Flow|LY2216684 + Quinidine (CYP2C19 Poor Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 poor metabolizer (PM) phenotype, as determined by genotyping analysis.~Period 1 (Days 1-7): a single, oral dose of 18 milligrams (mg) LY2216684 was administered on Day 1.~Period 2 (Days 8-15): 300 mg quinidine sulfate controlled release was administered orally, once daily on Days 8-15. Additionally, a single, oral dose of 18 mg LY2216684 was administered on Day 11."
11078538|NCT01460381|FG001|Participant Flow|LY2216684 (CYP2C19 Extensive Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 extensive metabolizer (EM) phenotype, as determined by genotyping analysis.~Period 1 (Days 1-7): a single, oral dose of 18 milligrams (mg) LY2216684 administered on Day 1.~Period 2 (Days 8-15): EM participants did not participate in this period."
11078539|NCT01460381|OG000|Outcome|LY2216684 (CYP2C19 Poor Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 poor metabolizer (PM) phenotype, as determined by genotyping analysis.~Period 1 (Days 1-7): a single, oral dose of 18 mg LY2216684 was administered on Day 1."
11078540|NCT01460381|OG001|Outcome|LY2216684 (CYP2C19 Extensive Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 extensive metabolizer (EM) phenotype, as determined by genotyping analysis.~Period 1 (Days 1-7): a single, oral dose of 18 mg LY2216684 administered on Day 1."
11078541|NCT01460381|OG000|Outcome|LY2216684 + Quinidine (CYP2C19 Poor Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 poor metabolizer (PM) phenotype, as determined by genotyping analysis.~Period 2 (Days 8-15): 300 mg quinidine sulfate controlled release was administered orally, once daily on Days 8-15. Additionally, a single, oral dose of 18 mg LY2216684 was administered on Day 11."
11078542|NCT01460381|EG000|Reported Event|LY2216684 (CYP2C19 Extensive and Poor Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 extensive metabolizer (EM) or poor metabolizer (PM) phenotype, as determined by genotyping analysis.~Period 1 (Days 1-7): a single, oral dose of 18 milligrams (mg) LY2216684 administered on Day 1."
11078543|NCT01460381|EG001|Reported Event|Quinidine (CYP2C19 Poor Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 poor metabolizer (PM) phenotype, as determined by genotyping analysis.~Period 2 (Days 8-11, prior to LY2216684 dose): 300 mg quinidine sulfate controlled release was administered orally, once daily on Days 8-11."
11078544|NCT01460381|EG002|Reported Event|LY2216684 + Quinidine (CYP2C19 Poor Metabolizers)|"Participants were predicted to have a cytochrome P450 (CYP)2C19 poor metabolizer (PM) phenotype, as determined by genotyping analysis.~Period 2 (Days 11-15, following LY2216684 dose): 300 mg quinidine sulfate controlled release was administered orally, once daily on Days 11-15. Additionally, a single, oral dose of 18 mg LY2216684 was administered on Day 11."
11078545|NCT01460407|BG000|Baseline|Entire Study Population|"LY2216684: a single 18-mg tablet on Day 1 and Day 10~Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13"
11078546|NCT01460407|FG000|Participant Flow|LY2216684|LY2216684: a single 18-milligram (mg) tablet on Day 1
11078547|NCT01460407|FG001|Participant Flow|LY2216684 and Clarithromycin|"LY2216684: a single 18-mg tablet on Day 10~Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13"
11078548|NCT01460407|OG000|Outcome|LY2216684|LY2216684: a single 18-mg tablet on Day 1
11078549|NCT01460407|OG001|Outcome|LY2216684 and Clarithromycin|"LY2216684: a single 18-mg tablet on Day 10~Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13"
11078550|NCT01460407|EG000|Reported Event|LY2216684|Adverse Events (AEs) that occurred from Day 1 postdose to Day 6 prior to dosing for all randomized participants.
11078551|NCT01460407|EG001|Reported Event|LY2216684 and Clarithromycin|AEs that occurred from Day 10 postdose to end of study (7 days post last dose) for all randomized participants.
11078552|NCT01460407|EG002|Reported Event|Clarithromycin|AEs that occurred from Day 6 postdose to Day 10 prior to dosing, for all randomized participants.
11078553|NCT01460446|BG000|Baseline|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11078554|NCT01460446|BG001|Baseline|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11078555|NCT01460446|BG002|Baseline|Total|Total of all reporting groups
11078556|NCT01460446|FG000|Participant Flow|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11078557|NCT01460446|FG001|Participant Flow|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11078558|NCT01460446|OG000|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11078559|NCT01460446|OG001|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11078560|NCT01460446|OG000|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11078561|NCT01460446|EG000|Reported Event|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11173654|NCT02016716|FG000|Participant Flow|Placebo|Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.
11078562|NCT01460446|EG001|Reported Event|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
11078563|NCT01460628|BG000|Baseline|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
11078564|NCT01460628|FG000|Participant Flow|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
11078565|NCT01460628|OG000|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
11078566|NCT01460628|EG000|Reported Event|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
11078567|NCT01460719|BG000|Baseline|V212|Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
11078568|NCT01460719|FG000|Participant Flow|V212|Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
11078569|NCT01460719|OG000|Outcome|V212|Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
11078570|NCT01460719|EG000|Reported Event|V212|Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
11227485|NCT02383420|FG001|Participant Flow|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
11078571|NCT01460732|BG000|Baseline|All Patients|All patients analyzed
11078572|NCT01460732|FG000|Participant Flow|All Patients|All patients analyzed
11078573|NCT01460732|OG000|Outcome|All Patients|All patients analyzed
11078574|NCT01460732|OG000|Outcome|ABPM|Dippers defined by ABPM.
11078575|NCT01460732|OG001|Outcome|HBPM-Nocturnal|Dippers defined by HBPM-Nocturnal.
11078576|NCT01460732|EG000|Reported Event|All Patients|All patients analyzed
11078577|NCT01460875|BG000|Baseline|Treatment (Interferon Therapy)|"Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.~recombinant interferon alfa-2b: Given SC~laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy."
11078578|NCT01460875|FG000|Participant Flow|Treatment (Interferon Therapy)|"Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.~recombinant interferon alfa-2b: Given SC~laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy."
11078579|NCT01460875|OG000|Outcome|Treatment (Interferon Therapy)|"Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.~recombinant interferon alfa-2b: Given SC~laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy."
11078580|NCT01460875|EG000|Reported Event|Treatment (Interferon Therapy)|"Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.~recombinant interferon alfa-2b: Given SC~laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy."
11078581|NCT01460901|BG000|Baseline|GD2 CAR Modified Tri-virus CTL|"This is a feasibility study to assess safety of an infusion of chimeric-antigen receptor gene modified allogeneic virus specific T lymphocytes after reduced intensity allogeneic stem cell transplant. The intent is to treat three patients and evaluate safety.~A single infusion of 2 million cells per meter squared was dosed.~Tri-virus specific cytotoxic t-cells: Infusion of donor derived tri-virus specific cytotoxic t-cell post allogeneic stem cell transplantation"
11078582|NCT01460901|FG000|Participant Flow|Treatment|Single arm study - GD2-CAR modified Tri-virus specific cytotoxic T-cell Infusion
11078583|NCT01460901|OG000|Outcome|GD2 CAR Modified Tri-virus CTL Infusion|Single arm study - Single infusion of 2x10e6 GD2 CAR modified tri-virus CTL following allogeneic stem cell transplant
11078584|NCT01460901|OG000|Outcome|Treatment|Single arm study - GD2 CAR Tri-virus CTL infusion
11078585|NCT01460901|OG000|Outcome|Treatment|Single arm study - GD2 CAR modified tri-virus specific CTL infusion
11078586|NCT01460901|OG000|Outcome|Treatment|Single arm study - treatment
11078587|NCT01460901|EG000|Reported Event|GD2 CAR Modified Tri-virus CTL Infusion|This was a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients were treated. Patients received infusion of tri-virus cytotoxic T-lymphocytes, transduced with a first generation GD2 targeted chimeric antigen receptor (tvs-CTL). Infusion of the tvs-CTL was performed 30 to 120 days after reduced intensity, mismatched related donor, CD34 selected peripheral blood stem cell transplant on a separate clinical trial. The tvs-CTL were derived from the stem cell transplant donor. Patients were monitored for safety of the allogeneic tvs-CTL at infusion and for adverse events such as graft vs host disease and insertional mutagenesis/carcinogenesis related to the gene transduction.
11078588|NCT01460927|BG000|Baseline|TriActive+ RF|Healthy male or female subjects 30-60 years of age, having at least two facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
11078589|NCT01460927|FG000|Participant Flow|TriActive+RF|"Subjects will receive up to 8 treatments on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2days) with evaluation follow-up visits at one (1) week (±2days), one (1) month (±4days), and three (3) months (±4days) following the final treatment. The treatments start at a low power (3W for the small tip, 10W for the medium and large tips) and then gradually increase the setting up to the highest powers available within the tips, checking the subject's tolerability and reaction of the tissue.~The power is adjusted to suit the subject's sensitivity and the depth of tissue to be treated (deeper tissue requires the larger tip). The goal is to progressively and smoothly reach an epidermal temperature end-point of 43°C. The treatment end-point correlates directly with the measurement of the skin temperature.~The temperature of 43°C should be maintained at the end point for several minutes (3-5min)."
11078590|NCT01460927|OG000|Outcome|Baseline|Baseline (before Treatments)
11078591|NCT01460927|OG001|Outcome|Pre Treatment 4|After 3 treatments
11078592|NCT01460927|OG002|Outcome|Pre Treatment 8|After 7 treatments
11078593|NCT01460927|OG003|Outcome|1 Month FU|1 Month after the 8th treatment
11078594|NCT01460927|OG004|Outcome|3 Month FU|3 Months after the 8th treatment
11078595|NCT01460927|EG000|Reported Event|TriActive+RF|Subjects will receive up to 8 treatments with the TriActive+ RF on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2 days).
11078596|NCT01460940|BG000|Baseline|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
11078597|NCT01460940|FG000|Participant Flow|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
11078598|NCT01460940|OG000|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
11078599|NCT01460940|EG000|Reported Event|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
11078600|NCT01461005|BG000|Baseline|DSS Stabilization System|DSS Stabilization System
11078601|NCT01461005|FG000|Participant Flow|Dynamic Stabilization System|"Dynamic Stabilization System (DSS) System~Dynamic Stabilization System (DSS): Dynamic Stabilization System"
11078602|NCT01461005|OG000|Outcome|Dynamic Stabilization System|"Dynamic Stabilization System (DSS) System~Dynamic Stabilization System (DSS): Dynamic Stabilization System"
11078603|NCT01461005|OG000|Outcome|DSS Stabilization System|DSS Stabilization System
11078604|NCT01461005|EG000|Reported Event|Dynamic Stabilization System|"Dynamic Stabilization System (DSS) System~Dynamic Stabilization System (DSS): Dynamic Stabilization System"
11078605|NCT01461044|BG000|Baseline|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078606|NCT01461044|BG001|Baseline|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078607|NCT01461044|BG002|Baseline|Total|Total of all reporting groups
11173655|NCT02016716|FG001|Participant Flow|Romosozumab 70 mg/mL|Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.
11173656|NCT02016716|FG002|Participant Flow|Romosozumab 90 mg/mL|Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
11078608|NCT01461044|FG000|Participant Flow|Bevacizumab: Hormone Receptor-Positive (HR+) Breast Cancer|Participants with human epidermal growth factor receptor 2 negative (HER2-) metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for greater than or equal to (>=) 12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078609|NCT01461044|FG001|Participant Flow|Bevacizumab: Triple Negative (TN) Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078610|NCT01461044|OG000|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078611|NCT01461044|OG001|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078612|NCT01461044|OG001|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078613|NCT01461044|OG000|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078614|NCT01461044|OG000|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HR+ cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months.
11078615|NCT01461044|EG000|Reported Event|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078616|NCT01461044|EG001|Reported Event|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
11078617|NCT01461057|BG000|Baseline|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles.
11078618|NCT01461057|BG001|Baseline|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
11078619|NCT01461057|BG002|Baseline|Total|Total of all reporting groups
11150337|NCT01877187|FG000|Participant Flow|Lipiodol|"Lipiodol, 10cc per TACE.~Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s)."
11150338|NCT01877187|OG000|Outcome|Lipiodol (HCC)|"Lipiodol, 10cc per TACE.~Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s)."
11078620|NCT01461057|FG000|Participant Flow|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles.
11078621|NCT01461057|FG001|Participant Flow|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
11078622|NCT01461057|OG000|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles.
11078623|NCT01461057|OG001|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
11078624|NCT01461057|EG000|Reported Event|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles.
11078625|NCT01461057|EG001|Reported Event|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
11078626|NCT01461096|BG000|Baseline|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11078627|NCT01461096|BG001|Baseline|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11078628|NCT01461096|BG002|Baseline|Total|Total of all reporting groups
11078629|NCT01461096|FG000|Participant Flow|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11078630|NCT01461096|FG001|Participant Flow|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11078631|NCT01461096|OG000|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11078632|NCT01461096|OG001|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11173657|NCT02016716|OG000|Outcome|Placebo|Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.
11173658|NCT02016716|OG001|Outcome|Romosozumab 70 mg/mL|Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.
11173659|NCT02016716|OG002|Outcome|Romosozumab 90 mg/mL|Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
11173660|NCT02016716|EG000|Reported Event|Placebo 70 mg|Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.
11173661|NCT02016716|EG001|Reported Event|Placebo 90 mg/mL|Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.
11173662|NCT02016716|EG002|Reported Event|Romosozumab 70 mg/mL|Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.
11078633|NCT01461096|OG001|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11078634|NCT01461096|EG000|Reported Event|qHPV|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11078635|NCT01461096|EG001|Reported Event|Placebo|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
11078636|NCT01461369|BG000|Baseline|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
11078637|NCT01461369|BG001|Baseline|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
11078638|NCT01461369|BG002|Baseline|Placebo|Placebo: Capsule
11078639|NCT01461369|BG003|Baseline|Total|Total of all reporting groups
11078640|NCT01461369|FG000|Participant Flow|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
11078641|NCT01461369|FG001|Participant Flow|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
11078642|NCT01461369|FG002|Participant Flow|Placebo|Placebo: Capsule
11078643|NCT01461369|OG000|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
11078644|NCT01461369|OG001|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
11078645|NCT01461369|OG002|Outcome|Placebo|Placebo: Capsule
11078646|NCT01461369|EG000|Reported Event|Diclofenac 35 mg Two Times Daily|Diclofenac Test (two times daily): Capsules
11078647|NCT01461369|EG001|Reported Event|Diclofenac 35 mg Three Times Daily|Diclofenac Test (three times daily): Capsules
11078648|NCT01461369|EG002|Reported Event|Placebo|Placebo: Capsule
11078649|NCT01461473|BG000|Baseline|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
11078650|NCT01461473|BG001|Baseline|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
11078651|NCT01461473|BG002|Baseline|Total|Total of all reporting groups
11078652|NCT01461473|FG000|Participant Flow|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
11078653|NCT01461473|FG001|Participant Flow|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
11078654|NCT01461473|OG000|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
11078655|NCT01461473|OG001|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
11078656|NCT01461473|EG000|Reported Event|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
11078657|NCT01461473|EG001|Reported Event|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
11078658|NCT01461499|BG000|Baseline|Direct Renin Inhibitor|Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
11078659|NCT01461499|BG001|Baseline|Angiotensin Receptor Blockers|any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
11078660|NCT01461499|BG002|Baseline|Total|Total of all reporting groups
11078661|NCT01461499|FG000|Participant Flow|Direct Renin Inhibitor|"Aliskiren:~A total of 119 patients were randomly assigned to receive direct renin inhibitor. Eight patients dropped out during the observation period and a total of 111 patients were studied in this group."
11078662|NCT01461499|FG001|Participant Flow|Angiotensin Receptor Blockers|A total of 118 patients were randomly assigned to receive angiotensin receptor blockers. Four patients dropped out during the observation period and a total of 114 patients were studied in this group.
11078663|NCT01461499|OG000|Outcome|Direct Renin Inhibitor|"Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.~A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group."
11078664|NCT01461499|OG001|Outcome|Angiotensin Receptor Blockers|"any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.~A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group."
11078665|NCT01461499|OG000|Outcome|Direct Renin Inhibitor|"Aliskiren:~A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group."
11078666|NCT01461499|OG001|Outcome|Angiotensin Receptor Blockers|Angiotensin receptor blockers: A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group.
11078667|NCT01461499|EG000|Reported Event|Direct Renin Inhibitor|"Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.~378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group."
11078668|NCT01461499|EG001|Reported Event|Angiotensin Receptor Blockers|"any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.~378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group."
11078669|NCT01461538|BG000|Baseline|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
11078670|NCT01461538|BG001|Baseline|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
11078671|NCT01461538|BG002|Baseline|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
11078672|NCT01461538|BG003|Baseline|Total|Total of all reporting groups
11078673|NCT01461538|FG000|Participant Flow|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
11078674|NCT01461538|FG001|Participant Flow|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
11078675|NCT01461538|FG002|Participant Flow|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
11078676|NCT01461538|OG000|Outcome|Solid Tumors|Participants with solid tumors
11078677|NCT01461538|OG001|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
11078678|NCT01461538|OG000|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
11078679|NCT01461538|OG001|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
11078680|NCT01461538|OG002|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
11078681|NCT01461538|EG000|Reported Event|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
11078682|NCT01461538|EG001|Reported Event|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
11078683|NCT01461538|EG002|Reported Event|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
11078684|NCT01461551|BG000|Baseline|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
11078685|NCT01461551|BG001|Baseline|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
11078686|NCT01461551|BG002|Baseline|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
11078687|NCT01461551|BG003|Baseline|Total|Total of all reporting groups
11078688|NCT01461551|FG000|Participant Flow|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
11078689|NCT01461551|FG001|Participant Flow|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
11078690|NCT01461551|FG002|Participant Flow|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
11078691|NCT01461551|OG000|Outcome|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
11078692|NCT01461551|OG001|Outcome|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
11078693|NCT01461551|OG002|Outcome|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
11078694|NCT01461551|EG000|Reported Event|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
11078695|NCT01461551|EG001|Reported Event|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
11078696|NCT01461551|EG002|Reported Event|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
11078697|NCT01461655|BG000|Baseline|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
11078698|NCT01461655|FG000|Participant Flow|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris.~The randomised subjects received the following products:~NSAID 5% gel , in the morning on the appropriate hemiface.~Topical retinoid 0.1% gel, in the evening on the entire face.~Vehicle gel, in the morning on the appropriate hemiface."
11078699|NCT01461655|OG000|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
11078700|NCT01461655|OG001|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
11078701|NCT01461655|EG000|Reported Event|Topical Retinoid - Placebo, Topical Retinoid - NSAID|
11078702|NCT01461668|BG000|Baseline|Retapamulin|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Retapamulin: Two times a day for 5 days"
11078703|NCT01461668|BG001|Baseline|Placebo|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Placebo: Two times a day for 5 days"
11078704|NCT01461668|BG002|Baseline|Total|Total of all reporting groups
11078705|NCT01461668|FG000|Participant Flow|Retapamulin|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Retapamulin: Two times a day for 5 days"
11078706|NCT01461668|FG001|Participant Flow|Placebo|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Placebo: Two times a day for 5 days"
11078707|NCT01461668|OG000|Outcome|Retapamulin|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Retapamulin: Two times a day for 5 days"
11150339|NCT01877187|OG001|Outcome|Lipiodol (Non-HCC)|"Lipiodol, 10cc per TACE.~Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s)."
11150340|NCT01877187|OG002|Outcome|Overall|Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
11078708|NCT01461668|OG001|Outcome|Placebo|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Placebo: Two times a day for 5 days"
11078709|NCT01461668|EG000|Reported Event|Retapamulin|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Retapamulin: Two times a day for 5 days"
11078710|NCT01461668|EG001|Reported Event|Placebo|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Placebo: Two times a day for 5 days"
11078711|NCT01461707|BG000|Baseline|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
11078712|NCT01461707|BG001|Baseline|Activity Monitor Group|Participants in the group will receive an activity monitor
11078713|NCT01461707|BG002|Baseline|Total|Total of all reporting groups
11078714|NCT01461707|FG000|Participant Flow|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
11078715|NCT01461707|FG001|Participant Flow|Activity Monitor Group|Participants in the group will receive an activity monitor
11078716|NCT01461707|OG000|Outcome|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
11078717|NCT01461707|OG001|Outcome|Activity Monitor Group|Participants in the group will receive an activity monitor
11078718|NCT01461707|EG000|Reported Event|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
11078719|NCT01461707|EG001|Reported Event|Activity Monitor Group|Participants in the group will receive an activity monitor
11078720|NCT01461733|BG000|Baseline|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
11078721|NCT01461733|BG001|Baseline|Placebo|Placebo: placebo delivered blinded
11078722|NCT01461733|BG002|Baseline|Total|Total of all reporting groups
11078723|NCT01461733|FG000|Participant Flow|Amiodarone|standard dose amiodarone
11078724|NCT01461733|FG001|Participant Flow|Placebo|
11078725|NCT01461733|OG000|Outcome|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
11078726|NCT01461733|OG001|Outcome|Placebo|Placebo: placebo delivered blinded
11078727|NCT01461733|EG000|Reported Event|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
11078728|NCT01461733|EG001|Reported Event|Placebo|Placebo: placebo delivered blinded
11078729|NCT01461811|BG000|Baseline|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
11078730|NCT01461811|BG001|Baseline|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
11078731|NCT01461811|BG002|Baseline|Total|Total of all reporting groups
11078732|NCT01461811|FG000|Participant Flow|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
11078733|NCT01461811|FG001|Participant Flow|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
11078734|NCT01461811|OG000|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
11078735|NCT01461811|OG001|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
11078736|NCT01461811|EG000|Reported Event|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
11078737|NCT01461811|EG001|Reported Event|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
11078738|NCT01461824|BG000|Baseline|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078739|NCT01461824|BG001|Baseline|104mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078740|NCT01461824|BG002|Baseline|75mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078741|NCT01461824|BG003|Baseline|Total|Total of all reporting groups
11078742|NCT01461824|FG000|Participant Flow|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078743|NCT01461824|FG001|Participant Flow|104mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078744|NCT01461824|FG002|Participant Flow|75mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078745|NCT01461824|OG000|Outcome|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078746|NCT01461824|OG001|Outcome|104mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078747|NCT01461824|OG002|Outcome|75mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
11078748|NCT01461824|EG000|Reported Event|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA):150mg DMPA, IM, every 12 weeks for 12 months
11078749|NCT01461824|EG001|Reported Event|104 mg DMPA|Depot medroxyprogesterone acetate (DMPA):104mg DMPA, IM, every 12 weeks for 12 months
11078750|NCT01461824|EG002|Reported Event|75 mg DMPA|Depot medroxyprogesterone acetate (DMPA):75mg DMPA, IM, every 12 weeks for 12 months
11078751|NCT01461863|BG000|Baseline|Protein Calorie Supplement|"250 gm daily of specially designed porridge plus standard multivitamin~Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein"
11078752|NCT01461863|BG001|Baseline|Multivitamin|"Standard multivitamin control~multivitamin: Standard multivitamin"
11078753|NCT01461863|BG002|Baseline|Total|Total of all reporting groups
11078754|NCT01461863|FG000|Participant Flow|Protein Calorie Supplement|"250 gm daily of specially designed porridge plus standard multivitamin~Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein"
11078755|NCT01461863|FG001|Participant Flow|Multivitamin|"Standard multivitamin control~multivitamin: Standard multivitamin"
11078756|NCT01461863|OG000|Outcome|Protein Calorie Supplement|"250 gm daily of specially designed porridge plus standard multivitamin~Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein"
11078757|NCT01461863|OG001|Outcome|Multivitamin|"Standard multivitamin control~multivitamin: Standard multivitamin"
11078758|NCT01461863|OG000|Outcome|Multivitamin|Multivitamin
11078759|NCT01461863|OG001|Outcome|Protein Calorie Supplement|
11078760|NCT01461863|EG000|Reported Event|Protein Calorie Supplement|"250 gm daily of specially designed porridge plus standard multivitamin~Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein"
11078761|NCT01461863|EG001|Reported Event|Multivitamin|"Standard multivitamin control~multivitamin: Standard multivitamin"
11078762|NCT01461928|BG000|Baseline|All Participants|Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
11078763|NCT01461928|FG000|Participant Flow|All Participants|Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
11078764|NCT01461928|FG001|Participant Flow|Maintenance II - Arm A (Rituximab)|Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
11078765|NCT01461928|FG002|Participant Flow|Maintenance II - Arm B (Observation Only)|Participants were randomized to no longer receive SC rituximab but observed until the end of study.
11078766|NCT01461928|OG000|Outcome|Maintenance II - Arm A (Rituximab)|Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
11078767|NCT01461928|OG001|Outcome|Maintenance II - Arm B (Observation Only)|Participants were randomized to no longer receive SC rituximab but observed until the end of study.
11078768|NCT01461928|OG000|Outcome|All Participants|Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
11150341|NCT01877187|OG000|Outcome|Lipiodol|"Lipiodol, 10cc per TACE.~Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s)."
11150342|NCT01877187|EG000|Reported Event|Lipiodol/TACE|"Lipiodol, 10cc per TACE.~Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).~Adverse events assessed in relation to TACE procedure."
11078769|NCT01461928|OG001|Outcome|All Participants|Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
11078770|NCT01461928|OG002|Outcome|All Participants|Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
11078771|NCT01461928|OG000|Outcome|Maintenance I|Participants received 12 cycles of rituximab administered as a single SC injection of 1400 mg without chemotherapy every 8 weeks for 2 years
11078772|NCT01461928|EG000|Reported Event|Arm A|Subjects received SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
11078773|NCT01461928|EG001|Reported Event|Arm B (Observation Only)|Subjects did not receive further rituximab treatment until the end of study.
11078774|NCT01461928|EG002|Reported Event|All Participants|Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
11078775|NCT01461980|BG000|Baseline|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
11078776|NCT01461980|BG001|Baseline|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
11078777|NCT01461980|BG002|Baseline|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
11078778|NCT01461980|BG003|Baseline|Total|Total of all reporting groups
11078779|NCT01461980|FG000|Participant Flow|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
11078780|NCT01461980|FG001|Participant Flow|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
11078781|NCT01461980|FG002|Participant Flow|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
11078782|NCT01461980|OG000|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
11078783|NCT01461980|OG001|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
11078784|NCT01461980|OG001|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
11078785|NCT01461980|OG002|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
11078786|NCT01461980|EG000|Reported Event|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
11078787|NCT01461980|EG001|Reported Event|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
11078788|NCT01461980|EG002|Reported Event|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
11078789|NCT01461993|BG000|Baseline|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11078790|NCT01461993|BG001|Baseline|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
11078791|NCT01461993|BG002|Baseline|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11078792|NCT01461993|BG003|Baseline|Total|Total of all reporting groups
11078793|NCT01461993|FG000|Participant Flow|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11078794|NCT01461993|FG001|Participant Flow|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
11078795|NCT01461993|FG002|Participant Flow|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11078796|NCT01461993|OG000|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11078797|NCT01461993|OG001|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11078798|NCT01461993|OG001|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
11078799|NCT01461993|OG002|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11227486|NCT02383420|FG002|Participant Flow|Predicate & Investigational-Cadavers|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
11227487|NCT02383420|OG000|Outcome|Predicate|DRX-1 Detector, Live Subjects and Cadavers
11227488|NCT02383420|OG001|Outcome|Investigational|DRX PRO 3543/C (GOS & CsI) Detectors, Live Subjects & Cadavers
11227489|NCT02383420|OG000|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-PRO 3543/C (GOS & CsI) and vice versa.
11227490|NCT02383420|EG000|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
11227491|NCT02383420|EG001|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
11227492|NCT02383420|EG002|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors.
11227493|NCT02383472|BG000|Baseline|MedX Health Console Model 1100|"The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches. Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line"
11227494|NCT02383472|BG001|Baseline|MedX Health Console Model 1100-placebo|"Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective."
11078800|NCT01461993|EG000|Reported Event|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11078801|NCT01461993|EG001|Reported Event|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
11078802|NCT01461993|EG002|Reported Event|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
11078803|NCT01462045|BG000|Baseline|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
11078804|NCT01462045|BG001|Baseline|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
11078805|NCT01462045|BG002|Baseline|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
11078806|NCT01462045|BG003|Baseline|Total|Total of all reporting groups
11227495|NCT02383472|BG002|Baseline|Total|Total of all reporting groups
11233732|NCT02430870|OG002|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11078807|NCT01462045|FG000|Participant Flow|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
11078808|NCT01462045|FG001|Participant Flow|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
11078809|NCT01462045|FG002|Participant Flow|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
11078810|NCT01462045|OG000|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
11078811|NCT01462045|OG001|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
11078812|NCT01462045|OG002|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
11078813|NCT01462045|EG000|Reported Event|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
11078814|NCT01462045|EG001|Reported Event|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
11078815|NCT01462045|EG002|Reported Event|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
11078816|NCT01462084|BG000|Baseline|Overall Study Population|All study patients included in final analysis.
11078817|NCT01462084|FG000|Participant Flow|Adaptive Servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so patients in this arm used ASV therapy the first night and then crossed over and used BiLevel PAP the second night.
11078818|NCT01462084|FG001|Participant Flow|Bi-Level PAP|Bi-level PAP delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so patients in this arm used Bi-Level PAP therapy the first night and then crossed over and used ASV the second night.
11078819|NCT01462084|OG000|Outcome|Adaptive Servo-Ventilation (ASV)|All patients received 1 night of therapy using Adaptive servo-ventilation (ASV) and 1 night of therapy using Bi-level PAP. Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
11078820|NCT01462084|OG001|Outcome|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
11078821|NCT01462084|OG000|Outcome|Adaptive Servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. Both pressures are fixed and do not adjust based on the individuals breathing events.
11078822|NCT01462084|EG000|Reported Event|Adaptive Servo-Ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
11078823|NCT01462084|EG001|Reported Event|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
11078824|NCT01462110|BG000|Baseline|5% Hydroalcohol Mouthrinse|Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
11078825|NCT01462110|BG001|Baseline|0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse|Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
11078826|NCT01462110|BG002|Baseline|Total|Total of all reporting groups
11078827|NCT01462110|FG000|Participant Flow|5% Hydroalcohol Mouthrinse|Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
11078828|NCT01462110|FG001|Participant Flow|0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse|Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
11078829|NCT01462110|OG000|Outcome|5% Hydroalcohol Mouthrinse|Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
11078830|NCT01462110|OG001|Outcome|0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse|Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
11078831|NCT01462110|EG000|Reported Event|5% Hydroalcohol Mouthrinse|Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
11227496|NCT02383472|FG000|Participant Flow|MedX Health Console Model 1100|"The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches. Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line"
11078832|NCT01462110|EG001|Reported Event|0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse|Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
11078833|NCT01462162|BG000|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
11078834|NCT01462162|FG000|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
11078835|NCT01462162|OG000|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
11078836|NCT01462162|OG000|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
11078837|NCT01462162|EG000|Reported Event|All Participants|Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
11078838|NCT01462227|BG000|Baseline|Naltrexone (Lower Dose)|Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally
11078839|NCT01462227|BG001|Baseline|Naltrexone (Higher Dose)|Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally
11078840|NCT01462227|BG002|Baseline|Total|Total of all reporting groups
11078841|NCT01462227|FG000|Participant Flow|Naltrexone (Lower Dose) First /Placebo Second|Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
11078842|NCT01462227|FG001|Participant Flow|Placebo First/ Naltrexone (Lower Dose) Second|Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally
11078843|NCT01462227|FG002|Participant Flow|Naltrexone (Higher Dose) First /Placebo Second|Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
11078844|NCT01462227|FG003|Participant Flow|Placebo First / Naltrexone (Higher Dose) Second|Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally
11078845|NCT01462227|OG000|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
11078846|NCT01462227|OG001|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
11078847|NCT01462227|EG000|Reported Event|Naltrexone (50 mg)|Naltrexone 50 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
11078848|NCT01462227|EG001|Reported Event|Placebo (Lower Dose Group)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
11078849|NCT01462227|EG002|Reported Event|Naltrexone (100 mg)|Naltrexone 100 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
11078850|NCT01462227|EG003|Reported Event|Placebo (Higher Dose)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
11078851|NCT01462253|BG000|Baseline|Clofarabine + Cyclophosphamide|"Patients received a maximum of two consecutive cycles of Clofarabine-Cyclophosphamide, at an intercycle interval of 28 days or greater, according to tolerability and clinical status.~Cycle 2 was only administered to patients obtaining at least a partial response (PR) after cycle 1."
11078852|NCT01462253|FG000|Participant Flow|Clofarabine + Cyclophosphamide|"Patients received a maximum of two consecutive cycles of Clofarabine-Cyclophosphamide, at an intercycle interval of 28 days or greater, according to tolerability and clinical status.~Cycle 2 was only administered to patients obtaining at least a partial response (PR) after cycle 1."
11078853|NCT01462253|OG000|Outcome|Clofarabine + Cyclophosphamide|"Patients received a maximum of two consecutive cycles of Clofarabine-Cyclophosphamide, at an intercycle interval of 28 days or greater, according to tolerability and clinical status.~Cycle 2 was only administered to patients obtaining at least a partial response (PR) after cycle 1."
11078854|NCT01462253|EG000|Reported Event|Clofarabine + Cyclophosphamide|"Patients received a maximum of two consecutive cycles of Clofarabine-Cyclophosphamide, at an intercycle interval of 28 days or greater, according to tolerability and clinical status.~Cycle 2 was only administered to patients obtaining at least a partial response (PR) after cycle 1."
11078855|NCT01462266|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
11078856|NCT01462266|BG001|Baseline|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
11078857|NCT01462266|BG002|Baseline|Total|Total of all reporting groups
11078858|NCT01462266|FG000|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
11078859|NCT01462266|FG001|Participant Flow|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
11078860|NCT01462266|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
11078861|NCT01462266|OG001|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
11078862|NCT01462266|EG000|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
11078863|NCT01462266|EG001|Reported Event|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
11078864|NCT01462279|BG000|Baseline|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
11078865|NCT01462279|FG000|Participant Flow|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
11078866|NCT01462279|OG000|Outcome|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
11078867|NCT01462279|EG000|Reported Event|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
11078868|NCT01462292|BG000|Baseline|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution.
11078869|NCT01462292|BG001|Baseline|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL.
11078870|NCT01462292|BG002|Baseline|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL.
11078871|NCT01462292|BG003|Baseline|Total|Total of all reporting groups
11078872|NCT01462292|FG000|Participant Flow|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 milliliter (mL) vials containing 1 mL sterile solution.
11078873|NCT01462292|FG001|Participant Flow|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 milligram (mg) per kilogram (kg) GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
11078874|NCT01462292|FG002|Participant Flow|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
11078875|NCT01462292|OG000|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
11078876|NCT01462292|OG001|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
11078877|NCT01462292|OG002|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL.
11078878|NCT01462292|OG002|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
11078879|NCT01462292|OG001|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
11078880|NCT01462292|OG002|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
11078881|NCT01462292|EG000|Reported Event|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
11078882|NCT01462292|EG001|Reported Event|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
11078883|NCT01462292|EG002|Reported Event|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
11078884|NCT01462305|BG000|Baseline|goLITE|"light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks~goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning"
11078885|NCT01462305|BG001|Baseline|Control|"light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks~Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks"
11078886|NCT01462305|BG002|Baseline|Total|Total of all reporting groups
11078887|NCT01462305|FG000|Participant Flow|goLITE|"light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks~goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning"
11078888|NCT01462305|FG001|Participant Flow|Control|"light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks~Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks"
11078889|NCT01462305|OG000|Outcome|goLITE|"light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks~goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning"
11078890|NCT01462305|OG001|Outcome|Control|"light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks~Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks"
11078891|NCT01462305|EG000|Reported Event|goLITE|"light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks~goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning"
11078892|NCT01462305|EG001|Reported Event|Control|"light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks~Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks"
11078893|NCT01462318|BG000|Baseline|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
11078894|NCT01462318|BG001|Baseline|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin's anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
11078895|NCT01462318|BG002|Baseline|Total|Total of all reporting groups
11078896|NCT01462318|FG000|Participant Flow|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
11078897|NCT01462318|FG001|Participant Flow|Therapeutic Protein-Drug Interaction (TP-DI)Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin's anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
11078898|NCT01462318|FG002|Participant Flow|Extension Phase|After completion of the washout period from the Main Study or the TP-DI sub-study, eligible participants had the option to resume monthly open-label treatment with DAC HYP 150 mg in the extension phase of the study for up to 3 additional years.
11078899|NCT01462318|OG000|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
11078900|NCT01462318|OG000|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin's anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
11078901|NCT01462318|EG000|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg by SC injection using the PFS every 4 weeks for24 weeks followed by a 20-week washout period. After completion of the washout period, participants could resume monthly DAC HYP 150 mg using the PFS for up to 3 additional years. Participants in the TP-DI sub-study received s probe-drug cocktail administration at Weeks 43 and 53. The probe-drug cocktail consisted of midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg. The oral vitamin K was used to counteract warfarin's anticoagulant effect prophylactically.
11078902|NCT01462344|BG000|Baseline|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
11078903|NCT01462344|BG001|Baseline|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
11078904|NCT01462344|BG002|Baseline|Total|Total of all reporting groups
11078905|NCT01462344|FG000|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
11078906|NCT01462344|FG001|Participant Flow|Fluticasone Propionate (FP)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
11078907|NCT01462344|OG000|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
11078908|NCT01462344|OG001|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
11078909|NCT01462344|EG000|Reported Event|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
11078910|NCT01462344|EG001|Reported Event|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
11078911|NCT01462357|BG000|Baseline|Cervarix 2 Dose Group|Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078912|NCT01462357|BG001|Baseline|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078913|NCT01462357|BG002|Baseline|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078914|NCT01462357|BG003|Baseline|Total|Total of all reporting groups
11078915|NCT01462357|FG000|Participant Flow|Cervarix 2 Dose Group|Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078916|NCT01462357|FG001|Participant Flow|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078917|NCT01462357|FG002|Participant Flow|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078918|NCT01462357|OG000|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078919|NCT01462357|OG001|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078920|NCT01462357|OG002|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078921|NCT01462357|EG000|Reported Event|Cervarix 2 Dose Group|Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078922|NCT01462357|EG001|Reported Event|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078923|NCT01462357|EG002|Reported Event|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
11078924|NCT01462435|BG000|Baseline|Celecoxib|Celecoxib : 200 mg Capsules
11078925|NCT01462435|BG001|Baseline|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
11078926|NCT01462435|BG002|Baseline|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
11078927|NCT01462435|BG003|Baseline|Placebo|Placebo : Capsules
11078928|NCT01462435|BG004|Baseline|Total|Total of all reporting groups
11078929|NCT01462435|FG000|Participant Flow|Celecoxib|Celecoxib : 200 mg Capsules
11078930|NCT01462435|FG001|Participant Flow|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
11078931|NCT01462435|FG002|Participant Flow|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
11078932|NCT01462435|FG003|Participant Flow|Placebo|Placebo : Capsules
11078933|NCT01462435|OG000|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
11078934|NCT01462435|OG001|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
11078935|NCT01462435|OG002|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
11078936|NCT01462435|OG003|Outcome|Placebo|Placebo : Capsules
11078937|NCT01462435|EG000|Reported Event|Celecoxib|Celecoxib : 200 mg Capsules
11078938|NCT01462435|EG001|Reported Event|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
11078939|NCT01462435|EG002|Reported Event|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
11078940|NCT01462435|EG003|Reported Event|Placebo|Placebo : Capsules
11078941|NCT01462565|BG000|Baseline|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
11078942|NCT01462565|FG000|Participant Flow|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 milliliter (mL) formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
11078943|NCT01462565|OG000|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
11078944|NCT01462565|EG000|Reported Event|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
11078945|NCT01462695|BG000|Baseline|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11078946|NCT01462695|BG001|Baseline|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11078947|NCT01462695|BG002|Baseline|Total|Total of all reporting groups
11078948|NCT01462695|FG000|Participant Flow|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11078949|NCT01462695|FG001|Participant Flow|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11173663|NCT02016716|EG003|Reported Event|Romosozumab 90 mg/mL|Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
11078950|NCT01462695|OG000|Outcome|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11078951|NCT01462695|OG001|Outcome|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11078952|NCT01462695|EG000|Reported Event|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11078953|NCT01462695|EG001|Reported Event|Stratum B: Recurrent Ependymoma|Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11078954|NCT01462773|BG000|Baseline|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22 and recombinant interferon alfa-2b SC on days 1, 3, and 5 (days 1 and 3 only in week 4 course 1) of weeks 1-4. Treatment repeats every 5 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
11078955|NCT01462773|FG000|Participant Flow|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
11078956|NCT01462773|OG000|Outcome|Bortezomib & Interferon-a|Patients were treated on a 5-week cycle. Week 1 of cycle 1, patients received 5 million U/m(2) IFN-a subcutaneously thrice weekly. Weeks 2-4 of cycle 1, bortezomib was administered intravenously weely along with IFN-a thrice weekly. A break from treatment during week 5. Folllowing cycle 1, bortezomib was administered in combination iwth IFN-a. Bortezomib was administered in escalating doses to cohorts of 3 patients.
11078957|NCT01462773|OG000|Outcome|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
11078958|NCT01462773|EG000|Reported Event|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients were treated on a 5-week cycle. In week 1 of cycle 1, patients received 5 million U/m(2) IFN-α subcutaneously thrice weekly. During weeks 2-4 of cycle 1, bortezomib was administered intravenously weekly along with IFN-α thrice weekly. There was a treatment break during week 5. After cycle 1, bortezomib was administered in combination with IFN-α. Bortezomib was administered in escalating doses (1.0, 1.3, or 1.6 mg/m) to cohorts of 3 patients.
11078959|NCT01462812|BG000|Baseline|Matching Placebo|Placebo : Matching placebo
11078960|NCT01462812|BG001|Baseline|Sumatriptan|Sumatriptan : Sumatriptan 20mg
11078961|NCT01462812|BG002|Baseline|Total|Total of all reporting groups
11078962|NCT01462812|FG000|Participant Flow|Matching Placebo|Placebo : Matching placebo
11078963|NCT01462812|FG001|Participant Flow|Sumatriptan|Sumatriptan : Sumatriptan 20mg
11078964|NCT01462812|OG000|Outcome|Matching Placebo|Placebo : Matching placebo
11078965|NCT01462812|OG001|Outcome|Sumatriptan|Sumatriptan : Sumatriptan 20mg
11078966|NCT01462812|EG000|Reported Event|Matching Placebo|Placebo : Matching placebo
11078967|NCT01462812|EG001|Reported Event|Sumatriptan|Sumatriptan : Sumatriptan 20mg
11078968|NCT01462877|BG000|Baseline|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
11078969|NCT01462877|FG000|Participant Flow|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
11078970|NCT01462877|OG000|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
11078971|NCT01462877|EG000|Reported Event|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
11078972|NCT01462929|BG000|Baseline|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
11078973|NCT01462929|BG001|Baseline|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
11078974|NCT01462929|BG002|Baseline|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
11078975|NCT01462929|BG003|Baseline|Total|Total of all reporting groups
11078976|NCT01462929|FG000|Participant Flow|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
11078977|NCT01462929|FG001|Participant Flow|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
11078978|NCT01462929|FG002|Participant Flow|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
11173664|NCT02016755|BG000|Baseline|AMG0001|"Hepatocyte Growth Factor (HGF) Plasmid~HGF Plasmid: Intramuscular injection in the affected limb."
11078979|NCT01462929|OG000|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
11078980|NCT01462929|OG001|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
11078981|NCT01462929|OG002|Outcome|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
11078982|NCT01462929|EG000|Reported Event|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
11078983|NCT01462929|EG001|Reported Event|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
11078984|NCT01462929|EG002|Reported Event|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
11078985|NCT01462942|BG000|Baseline|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078986|NCT01462942|BG001|Baseline|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078987|NCT01462942|BG002|Baseline|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078988|NCT01462942|BG003|Baseline|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078989|NCT01462942|BG004|Baseline|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078990|NCT01462942|BG005|Baseline|Total|Total of all reporting groups
11078991|NCT01462942|FG000|Participant Flow|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078992|NCT01462942|FG001|Participant Flow|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078993|NCT01462942|FG002|Participant Flow|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078994|NCT01462942|FG003|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078995|NCT01462942|FG004|Participant Flow|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078996|NCT01462942|OG000|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078997|NCT01462942|OG001|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078998|NCT01462942|OG002|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11078999|NCT01462942|OG003|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11079000|NCT01462942|OG004|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
11079001|NCT01462942|EG000|Reported Event|Placebo|
11079002|NCT01462942|EG001|Reported Event|Aclidinium/Formoterol 400/12 μg|
11079003|NCT01462942|EG002|Reported Event|Aclidinium/Formoterol 400/6 μg|
11079004|NCT01462942|EG003|Reported Event|Aclidinium 400 μg|
11079005|NCT01462942|EG004|Reported Event|Formoterol 12 μg|
11079006|NCT01463007|BG000|Baseline|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
11079007|NCT01463007|FG000|Participant Flow|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
11079008|NCT01463007|OG000|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
11079009|NCT01463007|OG001|Outcome|Extended to 5 Years of Follow Up-Rhode Island Hospital Only|Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
11079010|NCT01463007|EG000|Reported Event|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
11079011|NCT01463033|BG000|Baseline|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
11079012|NCT01463033|BG001|Baseline|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
11079013|NCT01463033|BG002|Baseline|Total|Total of all reporting groups
11079014|NCT01463033|FG000|Participant Flow|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
11079015|NCT01463033|FG001|Participant Flow|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
11079016|NCT01463033|OG000|Outcome|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
11079017|NCT01463033|OG001|Outcome|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
11079018|NCT01463033|OG000|Outcome|Participants|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. schedule were monitored for adverse events through the 30 day treatment period.
11079019|NCT01463033|EG000|Reported Event|Levetiracetam|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
11079020|NCT01463033|EG001|Reported Event|Observational|Adverse events were not monitored for the Observational group
11079021|NCT01463098|BG000|Baseline|Part A: E2006 Matched Placebo|Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079022|NCT01463098|BG001|Baseline|Part A: E2006 1.0 mg|Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079023|NCT01463098|BG002|Baseline|Part A: E2006 2.5 mg|Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079024|NCT01463098|BG003|Baseline|Part A: E2006 5 mg|Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079025|NCT01463098|BG004|Baseline|Part A: E2006 10 mg|Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079026|NCT01463098|BG005|Baseline|Part A: E2006 25 mg|Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079027|NCT01463098|BG006|Baseline|Part A: E2006 50 mg|Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079028|NCT01463098|BG007|Baseline|Part A: E2006 100 mg|Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079029|NCT01463098|BG008|Baseline|Part A: E2006 200 mg|Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079030|NCT01463098|BG009|Baseline|Part B: E2006 Matched Placebo or Zolpidem Matched Placebo|Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079031|NCT01463098|BG010|Baseline|Part B: Zolpidem 10 mg|Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079032|NCT01463098|BG011|Baseline|Part B: E2006 2.5 mg|Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079033|NCT01463098|BG012|Baseline|Part B: E2006 10 mg|Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079034|NCT01463098|BG013|Baseline|Part B: E2006 25 mg|Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079035|NCT01463098|BG014|Baseline|Total|Total of all reporting groups
11079036|NCT01463098|FG000|Participant Flow|Part A: E2006 Matched Placebo|Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079037|NCT01463098|FG001|Participant Flow|Part A: E2006 1.0 mg|Healthy participants received E2006 1 milligram (mg), capsule, orally in the morning, one hour after lights-on, on Day 1.
11079038|NCT01463098|FG002|Participant Flow|Part A: E2006 2.5 mg|Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079039|NCT01463098|FG003|Participant Flow|Part A: E2006 5 mg|Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079040|NCT01463098|FG004|Participant Flow|Part A: E2006 10 mg|Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079041|NCT01463098|FG005|Participant Flow|Part A: E2006 25 mg|Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079042|NCT01463098|FG006|Participant Flow|Part A: E2006 50 mg|Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079043|NCT01463098|FG007|Participant Flow|Part A: E2006 100 mg|Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079044|NCT01463098|FG008|Participant Flow|Part A: E2006 200 mg|Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11173665|NCT02016755|FG000|Participant Flow|AMG0001|"Hepatocyte Growth Factor (HGF) Plasmid~HGF Plasmid: Intramuscular injection in the affected limb."
11079045|NCT01463098|FG009|Participant Flow|Part B: E2006 Matched Placebo or Zolpidem Matched Placebo|Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079046|NCT01463098|FG010|Participant Flow|Part B: Zolpidem 10 mg|Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079047|NCT01463098|FG011|Participant Flow|Part B: E2006 2.5 mg|Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079048|NCT01463098|FG012|Participant Flow|Part B: E2006 10 mg|Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079049|NCT01463098|FG013|Participant Flow|Part B: E2006 25 mg|Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079050|NCT01463098|OG000|Outcome|Part A: E2006 Matched Placebo|Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079051|NCT01463098|OG001|Outcome|Part A: E2006 1.0 mg|Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079052|NCT01463098|OG002|Outcome|Part A: E2006 2.5 mg|Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079053|NCT01463098|OG003|Outcome|Part A: E2006 5 mg|Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079054|NCT01463098|OG004|Outcome|Part A: E2006 10 mg|Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079055|NCT01463098|OG005|Outcome|Part A: E2006 25 mg|Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079056|NCT01463098|OG006|Outcome|Part A: E2006 50 mg|Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079057|NCT01463098|OG007|Outcome|Part A: E2006 100 mg|Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079058|NCT01463098|OG008|Outcome|Part A: E2006 200 mg|Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079059|NCT01463098|OG000|Outcome|Part B: E2006 Matched Placebo or Zolpidem Matched Placebo|Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079060|NCT01463098|OG001|Outcome|Part B: Zolpidem 10 mg|Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079061|NCT01463098|OG002|Outcome|Part B: E2006 2.5 mg|Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079062|NCT01463098|OG003|Outcome|Part B: E2006 10 mg|Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079063|NCT01463098|OG004|Outcome|Part B: E2006 25 mg|Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079064|NCT01463098|OG000|Outcome|Part A: E2006 1.0 mg|Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079065|NCT01463098|OG001|Outcome|Part A: E2006 2.5 mg|Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079066|NCT01463098|OG002|Outcome|Part A: E2006 5 mg|Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079067|NCT01463098|OG003|Outcome|Part A: E2006 10 mg|Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079068|NCT01463098|OG004|Outcome|Part A: E2006 25 mg|Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079069|NCT01463098|OG005|Outcome|Part A: E2006 50 mg|Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079070|NCT01463098|OG006|Outcome|Part A: E2006 100 mg|Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079071|NCT01463098|OG007|Outcome|Part A: E2006 200 mg|Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079072|NCT01463098|OG000|Outcome|Part A: Placebo: Matched to 1, 2.5, 5 mg E2006|Healthy participants received E2006-matched placebo (matched to 1 mg, 2.5 mg and 5 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1.
11079073|NCT01463098|OG001|Outcome|Part A: Placebo: Matched to 10, 25, 50, 100, 200 mg E2006|Healthy participants received E2006-matched placebo (matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1.
11079074|NCT01463098|OG002|Outcome|Part A: E2006 1.0 mg|Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079075|NCT01463098|OG003|Outcome|Part A: E2006 2.5 mg|Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079076|NCT01463098|OG004|Outcome|Part A: E2006 5 mg|Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079077|NCT01463098|OG005|Outcome|Part A: E2006 10 mg|Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079078|NCT01463098|OG006|Outcome|Part A: E2006 25 mg|Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079079|NCT01463098|OG007|Outcome|Part A: E2006 50 mg|Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079080|NCT01463098|OG008|Outcome|Part A: E2006 100 mg|Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079081|NCT01463098|OG009|Outcome|Part A: E2006 200 mg|Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079082|NCT01463098|OG000|Outcome|Part A: Placebo: Matched to 1, 2.5, 5 mg E2006|Healthy participants received E2006-matched placebo (matched to 1 mg, 2,5 mg and 5 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1.
11079083|NCT01463098|EG000|Reported Event|Part A: E2006 Matched Placebo|Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079084|NCT01463098|EG001|Reported Event|Part A: E2006 1.0 mg|Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079085|NCT01463098|EG002|Reported Event|Part A: E2006 2.5 mg|Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079086|NCT01463098|EG003|Reported Event|Part A: E2006 5 mg|Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079087|NCT01463098|EG004|Reported Event|Part A: E2006 10 mg|Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079088|NCT01463098|EG005|Reported Event|Part A: E2006 25 mg|Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079089|NCT01463098|EG006|Reported Event|Part A: E2006 50 mg|Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
11079090|NCT01463098|EG007|Reported Event|Part A: E2006 100 mg|Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079091|NCT01463098|EG008|Reported Event|Part A: E2006 200 mg|Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
11079092|NCT01463098|EG009|Reported Event|Part B: E2006 Matched Placebo or Zolpidem Matched Placebo|Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079093|NCT01463098|EG010|Reported Event|Part B: Zolpidem 10 mg|Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079094|NCT01463098|EG011|Reported Event|Part B: E2006 2.5 mg|Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079095|NCT01463098|EG012|Reported Event|Part B: E2006 10 mg|Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079096|NCT01463098|EG013|Reported Event|Part B: E2006 25 mg|Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
11079097|NCT01463111|BG000|Baseline|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
11079098|NCT01463111|FG000|Participant Flow|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
11079099|NCT01463111|OG000|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
11079100|NCT01463111|EG000|Reported Event|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
11079101|NCT01463202|BG000|Baseline|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
11079102|NCT01463202|BG001|Baseline|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
11079103|NCT01463202|BG002|Baseline|Total|Total of all reporting groups
11079104|NCT01463202|FG000|Participant Flow|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
11079105|NCT01463202|FG001|Participant Flow|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
11079106|NCT01463202|OG000|Outcome|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
11079107|NCT01463202|OG001|Outcome|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
11079108|NCT01463202|EG000|Reported Event|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
11079109|NCT01463202|EG001|Reported Event|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
11079110|NCT01463267|BG000|Baseline|Device 2 Passive|"Device 2 will NOT remind patients to take medications~Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders."
11079111|NCT01463267|BG001|Baseline|Device 2 Active|"Device 2 will remind patients to take medications~iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication."
11079112|NCT01463267|BG002|Baseline|Device 1 Active|"Device 1 will remind patients to take their medications~iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication."
11079113|NCT01463267|BG003|Baseline|Device 1 Passive|"Device 1 will NOT remind patients to take medications.~Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders."
11079114|NCT01463267|BG004|Baseline|Total|Total of all reporting groups
11079115|NCT01463267|FG000|Participant Flow|Device 2 Passive|"Device 2 will NOT remind patients to take medications~Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders."
11079116|NCT01463267|FG001|Participant Flow|Device 2 Active|"Device 2 will remind patients to take medications~iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication."
11079117|NCT01463267|FG002|Participant Flow|Device 1 Active|"Device 1 will remind patients to take their medications~iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication."
11079118|NCT01463267|FG003|Participant Flow|Device 1 Passive|"Device 1 will NOT remind patients to take medications.~Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders."
11079119|NCT01463267|OG000|Outcome|Device 2 Passive|"Device 2 will NOT remind patients to take medications~Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders."
11079120|NCT01463267|OG001|Outcome|Device 2 Active|"Device 2 will remind patients to take medications~iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication."
11079121|NCT01463267|OG002|Outcome|Device 1 Active|"Device 1 will remind patients to take their medications~iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication."
11079122|NCT01463267|OG003|Outcome|Device 1 Passive|"Device 1 will NOT remind patients to take medications.~Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders."
11079123|NCT01463267|EG000|Reported Event|Device 2 Passive|"Device 2 will NOT remind patients to take medications~Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders."
11079124|NCT01463267|EG001|Reported Event|Device 2 Active|"Device 2 will remind patients to take medications~iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication."
11079125|NCT01463267|EG002|Reported Event|Device 1 Active|"Device 1 will remind patients to take their medications~iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication."
11079126|NCT01463267|EG003|Reported Event|Device 1 Passive|"Device 1 will NOT remind patients to take medications.~Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders."
11091886|NCT01536574|EG000|Reported Event|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
11091887|NCT01536574|EG001|Reported Event|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
11091888|NCT01536587|BG000|Baseline|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
10849887|NCT00299104|EG002|Reported Event|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
11091889|NCT01536587|FG000|Participant Flow|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
11091890|NCT01536587|OG000|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
11091891|NCT01536587|EG000|Reported Event|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
11091892|NCT01536704|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
11091893|NCT01536704|FG000|Participant Flow|2 Milligram (mg) Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11091894|NCT01536704|FG001|Participant Flow|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11173666|NCT02016755|OG000|Outcome|AMG0001|"Hepatocyte Growth Factor (HGF) Plasmid~HGF Plasmid: Intramuscular injection in the affected limb."
11079127|NCT01463306|BG000|Baseline|Pregabalin: Previous and Current|Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age <4 years and BID when age >=4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.
11079128|NCT01463306|BG001|Baseline|Placebo-Previous to Pregabalin-Current|Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.
11079129|NCT01463306|BG002|Baseline|Direct Pregabalin|Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
11079130|NCT01463306|BG003|Baseline|Total|Total of all reporting groups
11079131|NCT01463306|FG000|Participant Flow|Pregabalin: Previous and Current|Pediatric and adult participants with partial onset seizures (POS) and primary generalized tonic-clonic (PGTC) seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered in 3 equally divided doses per day (TID) when age less than (<) 4 years and in 2 equally divided doses per day (BID) when age greater than or equal to (>=) 4 years. Pediatric participants with body weight >=30 kilogram (kg) received pregabalin 2.5 milligram per kilogram per day (mg/kg/day) as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 milligram per day (mg/day) as liquid oral solution/oral capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.
11079132|NCT01463306|FG001|Participant Flow|Placebo-Previous to Pregabalin-Current|Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.
11079133|NCT01463306|FG002|Participant Flow|Direct Pregabalin|Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
11079134|NCT01463306|OG000|Outcome|Pregabalin: Previous and Current|Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age <4 years and BID when age >=4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.
11079135|NCT01463306|OG001|Outcome|Placebo-Previous to Pregabalin-Current|Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.
11173667|NCT02016755|EG000|Reported Event|AMG0001|"Hepatocyte Growth Factor (HGF) Plasmid~HGF Plasmid: Intramuscular injection in the affected limb."
11079136|NCT01463306|OG002|Outcome|Direct Pregabalin|Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
11079137|NCT01463306|EG000|Reported Event|Pregabalin: Previous and Current|Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age <4 years and BID when age >=4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.
11091895|NCT01536704|FG002|Participant Flow|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11091896|NCT01536704|FG003|Participant Flow|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11079138|NCT01463306|EG001|Reported Event|Placebo-Previous to Pregabalin-Current|Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.
11079139|NCT01463306|EG002|Reported Event|Direct Pregabalin|Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
11079140|NCT01463358|BG000|Baseline|DDI30|"Control group based only on backup pacing with lower rate 30 ppm~DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms."
11079141|NCT01463358|BG001|Baseline|DDD60|"Treatment arm based on full pacing support (60 Lower Rate)~DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block"
11079142|NCT01463358|BG002|Baseline|Total|Total of all reporting groups
11079143|NCT01463358|FG000|Participant Flow|DDI30|"Control group based only on backup pacing with lower rate 30 ppm~DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms."
11079144|NCT01463358|FG001|Participant Flow|DDD60|"Treatment arm based on full pacing support (60 Lower Rate)~DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block"
11079145|NCT01463358|OG000|Outcome|DDI30|"Control group based only on backup pacing with lower rate 30 ppm~DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms."
11079146|NCT01463358|OG001|Outcome|DDD60|"Treatment arm based on full pacing support (60 Lower Rate)~DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block"
11079147|NCT01463358|EG000|Reported Event|DDI30|Control group based only on backup pacing with lower rate 30 ppm DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.
11079148|NCT01463358|EG001|Reported Event|DDD60|Treatment arm based on full pacing support (60 Lower Rate) DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block
11079149|NCT01463384|BG000|Baseline|Minocycline|Subjects administered 50mg minocycline twice daily for 6 months
11079150|NCT01463384|FG000|Participant Flow|Minocycline|Subjects were administered 50mg minocycline twice daily for 6 months
11079151|NCT01463384|OG000|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
11079152|NCT01463384|OG001|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
11079153|NCT01463384|OG002|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
11079154|NCT01463384|EG000|Reported Event|Minocycline|No adverse events were reported in any subjects who were taking minocycline. All subjects underwent monthly blood tests to monitor alanine transaminase and blood urea nitrogen levels.
11079155|NCT01463527|BG000|Baseline|Open Capnography|Staff members able to view capnography monitor during sedation.
11079156|NCT01463527|BG001|Baseline|Capnography Blind|Staff members were blinded to screen on capnography monitor and all alarms turned off for the sedation.
11079157|NCT01463527|BG002|Baseline|Total|Total of all reporting groups
11079158|NCT01463527|FG000|Participant Flow|Open Capnography|Staff members able to view capnography monitor during sedation.
11079159|NCT01463527|FG001|Participant Flow|Capnography Blind|Staff members blinded to capnography screen and alarms turned off during sedation.
11079160|NCT01463527|OG000|Outcome|Open Capnography|Staff able to view capnography monitor during sedation.
11079161|NCT01463527|OG001|Outcome|Capnography Blind|Staff blinded to capnography screen and alarms turned off during sedation.
11079162|NCT01463527|EG000|Reported Event|Open Capnography|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
11079163|NCT01463527|EG001|Reported Event|Capnography Blind|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
11079164|NCT01463631|BG000|Baseline|20 mg LY3007113 (Cohort 1)|20 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
11079165|NCT01463631|BG001|Baseline|40 mg LY3007113 (Cohort 2)|40 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
11079166|NCT01463631|BG002|Baseline|30 mg LY3007113 (Cohort 3)|30 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
11079167|NCT01463631|BG003|Baseline|30 mg LY3007113 (Part B)|30 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
11079168|NCT01463631|BG004|Baseline|Total|Total of all reporting groups
11079169|NCT01463631|FG000|Participant Flow|20 mg LY3007113 (Cohort 1)|20 milligrams (mg) LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079170|NCT01463631|FG001|Participant Flow|40 mg LY3007113 (Cohort 2)|40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079171|NCT01463631|FG002|Participant Flow|30 mg LY3007113 (Cohort 3)|30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079172|NCT01463631|FG003|Participant Flow|30 mg LY3007113 (Part B)|30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079173|NCT01463631|OG000|Outcome|20 mg LY3007113 (Cohort 1)|20 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079174|NCT01463631|OG001|Outcome|40 mg LY3007113 (Cohort 2)|40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079175|NCT01463631|OG002|Outcome|30 mg LY3007113 (Cohort 3)|30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079176|NCT01463631|OG003|Outcome|30 mg LY3007113 (Part B)|30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079177|NCT01463631|OG000|Outcome|30 mg LY3007113 (Part B)|30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079178|NCT01463631|OG002|Outcome|30 mg LY3007113 (Cohort 3 and Part B)|30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
11079179|NCT01463631|EG000|Reported Event|20 mg LY3007113 (Cohort 1)|20 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
11079180|NCT01463631|EG001|Reported Event|40 mg LY3007113 (Cohort 2)|40 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
11079181|NCT01463631|EG002|Reported Event|30 mg LY3007113 (Cohort 3)|30 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
11079182|NCT01463631|EG003|Reported Event|30 mg LY3007113 (Part B)|30 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
11079183|NCT01463683|BG000|Baseline|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
11079184|NCT01463683|BG001|Baseline|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
11079185|NCT01463683|BG002|Baseline|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11079186|NCT01463683|BG003|Baseline|Total|Total of all reporting groups
11079187|NCT01463683|FG000|Participant Flow|V232-2XP Subcutaneous (SC)|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
11079188|NCT01463683|FG001|Participant Flow|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
11079189|NCT01463683|FG002|Participant Flow|V232-2XP Intramuscular (IM)|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11079190|NCT01463683|OG000|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
11079191|NCT01463683|OG001|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
11079192|NCT01463683|OG002|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11079193|NCT01463683|EG000|Reported Event|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
11079194|NCT01463683|EG001|Reported Event|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
11079195|NCT01463683|EG002|Reported Event|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
11079196|NCT01463696|BG000|Baseline|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
11079197|NCT01463696|BG001|Baseline|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
11079198|NCT01463696|BG002|Baseline|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
11079199|NCT01463696|BG003|Baseline|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
11079200|NCT01463696|BG004|Baseline|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
11079201|NCT01463696|BG005|Baseline|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
11079202|NCT01463696|BG006|Baseline|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
11079203|NCT01463696|BG007|Baseline|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
11079204|NCT01463696|BG008|Baseline|Total|Total of all reporting groups
11079205|NCT01463696|FG000|Participant Flow|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered orally (PO) twice a day (BID) on Days 1-6 and PO once daily (QD) in the morning on Day 7 of the 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
11079206|NCT01463696|FG001|Participant Flow|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
11079207|NCT01463696|FG002|Participant Flow|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
11079208|NCT01463696|FG003|Participant Flow|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
11079209|NCT01463696|FG004|Participant Flow|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
11079210|NCT01463696|FG005|Participant Flow|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
11079211|NCT01463696|FG006|Participant Flow|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
11079212|NCT01463696|FG007|Participant Flow|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
11079213|NCT01463696|OG000|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
11079214|NCT01463696|OG001|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
11079215|NCT01463696|OG002|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
11079216|NCT01463696|OG003|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
11079217|NCT01463696|OG004|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
11079218|NCT01463696|OG005|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
11079219|NCT01463696|OG006|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
11173668|NCT02016885|BG000|Baseline|Glycopyrrolate, 1.0%|glycopyrrolate Topical Wipes, 1.0%
11079220|NCT01463696|OG007|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
11079221|NCT01463696|EG000|Reported Event|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
11079222|NCT01463696|EG001|Reported Event|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
11079223|NCT01463696|EG002|Reported Event|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
11079224|NCT01463696|EG003|Reported Event|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
11079225|NCT01463696|EG004|Reported Event|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
11079226|NCT01463696|EG005|Reported Event|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
11079227|NCT01463696|EG006|Reported Event|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
11079228|NCT01463696|EG007|Reported Event|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
11079229|NCT01463878|BG000|Baseline|Glycerna|Diabetic specific formula
11079230|NCT01463878|BG001|Baseline|Control - Jevity|The control arm of the study. Patients to receive Jevity
11079231|NCT01463878|BG002|Baseline|Total|Total of all reporting groups
11079232|NCT01463878|FG000|Participant Flow|Glycerna|Diabetic specific formula
11079233|NCT01463878|FG001|Participant Flow|Control - Jevity|The control arm of the study. Patients to receive Jevity
11079234|NCT01463878|OG000|Outcome|Glycerna|Diabetic specific formula
11079235|NCT01463878|OG001|Outcome|Control - Jevity|The control arm of the study. Patients to receive Jevity
11079236|NCT01463878|EG000|Reported Event|Glycerna|Diabetic specific formula
11079237|NCT01463878|EG001|Reported Event|Control - Jevity|The control arm of the study. Patients to receive Jevity
11079238|NCT01463982|BG000|Baseline|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079239|NCT01463982|BG001|Baseline|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079240|NCT01463982|BG002|Baseline|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079241|NCT01463982|BG003|Baseline|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079242|NCT01463982|BG004|Baseline|Total|Total of all reporting groups
11079243|NCT01463982|FG000|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079244|NCT01463982|FG001|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079245|NCT01463982|FG002|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079246|NCT01463982|FG003|Participant Flow|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079247|NCT01463982|OG000|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079248|NCT01463982|OG001|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11091897|NCT01536704|OG000|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
11079249|NCT01463982|OG002|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079250|NCT01463982|OG003|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079251|NCT01463982|EG000|Reported Event|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079252|NCT01463982|EG001|Reported Event|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079253|NCT01463982|EG002|Reported Event|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079254|NCT01463982|EG003|Reported Event|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
11079255|NCT01464021|BG000|Baseline|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
11079256|NCT01464021|FG000|Participant Flow|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
11079257|NCT01464021|OG000|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
11079258|NCT01464021|EG000|Reported Event|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
11079259|NCT01464190|BG000|Baseline|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
11079260|NCT01464190|BG001|Baseline|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
11079261|NCT01464190|BG002|Baseline|Total|Total of all reporting groups
11079262|NCT01464190|FG000|Participant Flow|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day)
11079263|NCT01464190|FG001|Participant Flow|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
11079264|NCT01464190|OG000|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
11079265|NCT01464190|OG001|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
11079266|NCT01464190|EG000|Reported Event|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
11079267|NCT01464190|EG001|Reported Event|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
11079268|NCT01464229|BG000|Baseline|Iloperidone, Then Placebo|Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks, in addition to SSRI antidepressant
11079269|NCT01464229|BG001|Baseline|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
11079270|NCT01464229|BG002|Baseline|Total|Total of all reporting groups
11079271|NCT01464229|FG000|Participant Flow|Iloperidone, Then Placebo|Iloperidone (1-8 mg) for 4 weeks, then placebo for 4 weeks; in addition to standard SSRI antidepressant
11079272|NCT01464229|FG001|Participant Flow|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks, then iloperidone for 4 weeks; in addition to standard SSRI antidepressant
11079273|NCT01464229|OG000|Outcome|Iloperidone, Then Placebo|Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks; addition to SSRI antidepressant
11079274|NCT01464229|OG001|Outcome|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
11079275|NCT01464229|EG000|Reported Event|Iloperidone|
11079276|NCT01464229|EG001|Reported Event|Placebo|
11079277|NCT01464255|BG000|Baseline|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
11079278|NCT01464255|BG001|Baseline|Ocufilcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
11079279|NCT01464255|BG002|Baseline|Total|Total of all reporting groups
11079280|NCT01464255|FG000|Participant Flow|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
11079281|NCT01464255|FG001|Participant Flow|Ocufulcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
11079282|NCT01464255|OG000|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
11079283|NCT01464255|OG001|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
11079284|NCT01464255|OG000|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
11173669|NCT02016885|BG001|Baseline|Glycopyrrolate, 2.0%|glycopyrrolate Topical Wipes, 2.0%
11079285|NCT01464255|EG000|Reported Event|Ocufilcon D|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
11079286|NCT01464255|EG001|Reported Event|Ocufilcon B|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
11079287|NCT01464307|BG000|Baseline|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
11079288|NCT01464307|BG001|Baseline|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
11079289|NCT01464307|BG002|Baseline|Total|Total of all reporting groups
11079290|NCT01464307|FG000|Participant Flow|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl), 400 units, total volume 8.0 milliliter (mL); Mode of administration: intramuscular injection.~IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection sessions of solution, prepared by reconstitution of powder with 0.9% NaCl, 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
11079291|NCT01464307|FG001|Participant Flow|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
11079292|NCT01464307|OG000|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
11079293|NCT01464307|OG001|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
11079294|NCT01464307|EG000|Reported Event|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
11079295|NCT01464307|EG001|Reported Event|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
11079296|NCT01464307|EG002|Reported Event|Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
11079297|NCT01464333|BG000|Baseline|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
11079298|NCT01464333|FG000|Participant Flow|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
11079299|NCT01464333|OG000|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
11079300|NCT01464333|EG000|Reported Event|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
11079301|NCT01464346|BG000|Baseline|All Subjects Entering the Study|All Subjects who provided consent, met inclusion/exclusion criteria and worn Enlite sensors
11079302|NCT01464346|FG000|Participant Flow|Enlite Sensor Abdomen/Abdomen|Subjects wearing 2 Enlite sensors in abdomen. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.
11079303|NCT01464346|FG001|Participant Flow|Enlite Sensor Abdomen/Buttock|Subjects wearing one Enlite sensor in Abdomen and one Enlite sensor in Buttock. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.
11079304|NCT01464346|FG002|Participant Flow|Enlite Sensor Buttock/Buttock|Subjects wearing 2 Enlite sensors in Buttock. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.
11079305|NCT01464346|OG000|Outcome|All Subjects|This group contains all subjects that enrolled in the study
11079306|NCT01464346|OG000|Outcome|All Subjects With Abdomen Insertion|This group contains all subjects with sensors inserted in the abdomen
11079307|NCT01464346|OG000|Outcome|All Subjects With Abdomen Insertion|All subjects that enrolled in the study and had sensors inserted in the abdomen insertion area.
11079308|NCT01464346|OG000|Outcome|All Subjects With Buttock Insertion|All subjects that enrolled in the study who had sensors inserted in the buttock insertion site.
11079309|NCT01464346|OG000|Outcome|All Subjects With Buttock Insertion|All subjects who enrolled in the study and had sensors inserted in the buttock insertion area.
11079310|NCT01464346|EG000|Reported Event|All Completed Subjects|All subjects that completed the study
11079311|NCT01464359|BG000|Baseline|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
11079312|NCT01464359|FG000|Participant Flow|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
11079313|NCT01464359|OG000|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
11079314|NCT01464359|EG000|Reported Event|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
11079315|NCT01464424|BG000|Baseline|Overall|Travoprost 0.004% and bimatoprost 0.01% in cross-over fashion, as randomized, 6 weeks each
11079316|NCT01464424|FG000|Participant Flow|TRAVATAN, Then LUMIGAN|Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
11079317|NCT01464424|FG001|Participant Flow|LUMIGAN, Then TRAVATAN|Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
11079318|NCT01464424|OG000|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
11079319|NCT01464424|OG001|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
11079320|NCT01464424|EG000|Reported Event|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
11079321|NCT01464424|EG001|Reported Event|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
11079322|NCT01464619|BG000|Baseline|Delayed Intervention|"Those assigned to the delayed intervention arm will receive enhanced mental health referrals, monthly follow-up phone calls, and will be assigned to the parenting intervention 3-4 months after enrollment.~Delayed Intervention: Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment."
11079323|NCT01464619|BG001|Baseline|Intervention|"Caregivers assigned to the intervention arm will be assigned to the Incredible Years parenting intervention immediately after enrollment. They will also receive enhanced mental health referrals and monthly follow-up phone calls.~The Incredible Years Parenting Intervention: The Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials."
11079324|NCT01464619|BG002|Baseline|Total|Total of all reporting groups
11079325|NCT01464619|FG000|Participant Flow|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
11079326|NCT01464619|FG001|Participant Flow|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
11079327|NCT01464619|OG000|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
11079328|NCT01464619|OG001|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
11079329|NCT01464619|OG000|Outcome|Intervention|Subjects received parenting intervention immediately
11079330|NCT01464619|OG001|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
11079331|NCT01464619|EG000|Reported Event|Intervention|Subjects received parenting intervention immediately
11079332|NCT01464619|EG001|Reported Event|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
11079333|NCT01464697|BG000|Baseline|Oral Micronized Progesterone|"Oral micronized progesterone is Prometrium 300 mg at bedtime daily~Oral micronized progesterone: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks"
11079334|NCT01464697|BG001|Baseline|Placebo Comparator|"Placebo~placebo: placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks"
11079335|NCT01464697|BG002|Baseline|Total|Total of all reporting groups
11079336|NCT01464697|FG000|Participant Flow|Oral Micronized Progesterone|"Oral micronized progesterone is Prometrium 300 mg at bedtime daily~Oral micronized progesterone: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks"
11079337|NCT01464697|FG001|Participant Flow|Placebo Comparator|"Placebo~placebo: placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks"
11079338|NCT01464697|OG000|Outcome|Oral Micronized Progesterone|"Oral micronized progesterone is Prometrium 300 mg at bedtime daily~Oral micronized progesterone: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks"
11079339|NCT01464697|OG001|Outcome|Placebo Comparator|"Placebo~placebo: placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks"
11079340|NCT01464697|EG000|Reported Event|Oral Micronized Progesterone|"Oral micronized progesterone is Prometrium 300 mg at bedtime daily~Oral micronized progesterone: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks"
11079341|NCT01464697|EG001|Reported Event|Placebo Comparator|"Placebo~placebo: placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks"
11079342|NCT01464775|BG000|Baseline|Narrow Band Imaging (NBI)|"Women will be randomized to white light/NBI versus white light/white light laparoscopy~NBI: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery"
11079343|NCT01464775|BG001|Baseline|White Light|"Women will be randomized to white light/NBI versus white light/white light laparoscopy~White light: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery"
11233733|NCT02430870|OG003|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11079344|NCT01464775|BG002|Baseline|Total|Total of all reporting groups
11079345|NCT01464775|FG000|Participant Flow|Narrow Band Imaging (NBI)|"Women will be randomized to white light/NBI versus white light/white light laparoscopy~NBI: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery"
11079346|NCT01464775|FG001|Participant Flow|White Light|"Women will be randomized to white light/NBI versus white light/white light laparoscopy~White light: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery"
11079347|NCT01464775|OG000|Outcome|Narrow Band Imaging (NBI)|"Women will be randomized to white light/NBI versus white light/white light laparoscopy~NBI: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery"
11079348|NCT01464775|OG001|Outcome|White Light|"Women will be randomized to white light/NBI versus white light/white light laparoscopy~White light: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery"
11079349|NCT01464775|OG000|Outcome|Narrow Band Imaging (NBI)|Of the women in the NBI/WL arm, lesions identified and biopsied in NBI sweep
11079350|NCT01464775|OG001|Outcome|White Light|Of the women in the NBI/WL arm, lesions identified and biopsied in the WL sweep
11079351|NCT01464775|EG000|Reported Event|Narrow Band Imaging (NBI)|"Women will be randomized to white light/NBI versus white light/white light laparoscopy~NBI: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery"
11079352|NCT01464775|EG001|Reported Event|White Light|"Women will be randomized to white light/NBI versus white light/white light laparoscopy~White light: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery"
11079353|NCT01464788|BG000|Baseline|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079354|NCT01464788|BG001|Baseline|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079355|NCT01464788|BG002|Baseline|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079356|NCT01464788|BG003|Baseline|Total|Total of all reporting groups
11079357|NCT01464788|FG000|Participant Flow|Low-dose Argatroban + Rt-PA (Alteplase)|"100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours.~and~Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour."
11079358|NCT01464788|FG001|Participant Flow|High Dose Argatroban + Rt-PA (Alteplase)|"Argatroban: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours.~and~Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour."
11079359|NCT01464788|FG002|Participant Flow|Rt-PA (Alteplase) Only|Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour.
11079360|NCT01464788|OG000|Outcome|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079361|NCT01464788|OG001|Outcome|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079362|NCT01464788|OG002|Outcome|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079363|NCT01464788|OG000|Outcome|Low Dose Argatroban + Rt-PA (Alteplase)|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079364|NCT01464788|OG001|Outcome|High Dose Argatroban + Rt-PA (Alteplase)|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079365|NCT01464788|EG000|Reported Event|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079366|NCT01464788|EG001|Reported Event|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079367|NCT01464788|EG002|Reported Event|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
11079368|NCT01464827|BG000|Baseline|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
11079369|NCT01464827|BG001|Baseline|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079370|NCT01464827|BG002|Baseline|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079371|NCT01464827|BG003|Baseline|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079372|NCT01464827|BG004|Baseline|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
11079373|NCT01464827|BG005|Baseline|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079374|NCT01464827|BG006|Baseline|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079375|NCT01464827|BG007|Baseline|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079376|NCT01464827|BG008|Baseline|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079377|NCT01464827|BG009|Baseline|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079378|NCT01464827|BG010|Baseline|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079379|NCT01464827|BG011|Baseline|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079380|NCT01464827|BG012|Baseline|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079381|NCT01464827|BG013|Baseline|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079382|NCT01464827|BG014|Baseline|Total|Total of all reporting groups
11079383|NCT01464827|FG000|Participant Flow|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
11079384|NCT01464827|FG001|Participant Flow|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079385|NCT01464827|FG002|Participant Flow|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079386|NCT01464827|FG003|Participant Flow|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079387|NCT01464827|FG004|Participant Flow|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
11079388|NCT01464827|FG005|Participant Flow|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079389|NCT01464827|FG006|Participant Flow|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079390|NCT01464827|FG007|Participant Flow|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079391|NCT01464827|FG008|Participant Flow|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079392|NCT01464827|FG009|Participant Flow|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079393|NCT01464827|FG010|Participant Flow|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079394|NCT01464827|FG011|Participant Flow|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079395|NCT01464827|FG012|Participant Flow|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079396|NCT01464827|FG013|Participant Flow|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079397|NCT01464827|OG000|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
11079398|NCT01464827|OG001|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079399|NCT01464827|OG002|Outcome|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079400|NCT01464827|OG003|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
11079401|NCT01464827|OG004|Outcome|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079402|NCT01464827|OG005|Outcome|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079403|NCT01464827|OG006|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
10851381|NCT00306202|BG001|Baseline|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
11079404|NCT01464827|OG007|Outcome|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079405|NCT01464827|OG008|Outcome|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079406|NCT01464827|OG000|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
11079407|NCT01464827|OG002|Outcome|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079408|NCT01464827|OG003|Outcome|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079409|NCT01464827|OG004|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
11079410|NCT01464827|OG005|Outcome|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079411|NCT01464827|OG006|Outcome|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079412|NCT01464827|OG007|Outcome|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079413|NCT01464827|OG008|Outcome|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079414|NCT01464827|OG009|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079415|NCT01464827|OG010|Outcome|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079416|NCT01464827|OG011|Outcome|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079417|NCT01464827|OG012|Outcome|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11173670|NCT02016885|BG002|Baseline|Glycopyrrolate, 3.0%|glycopyrrolate Topical Wipes, 3.0%
11079418|NCT01464827|OG013|Outcome|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079419|NCT01464827|OG001|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079420|NCT01464827|OG002|Outcome|Groups H + I + M + N|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079421|NCT01464827|OG000|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079422|NCT01464827|OG001|Outcome|Groups C + D + J|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079423|NCT01464827|OG002|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079424|NCT01464827|OG000|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily, for 12 weeks.
11079425|NCT01464827|OG000|Outcome|Groups F + G + H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
11079426|NCT01464827|OG001|Outcome|Groups K + L + M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
11079427|NCT01464827|EG000|Reported Event|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
11079428|NCT01464827|EG001|Reported Event|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
11079429|NCT01464827|EG002|Reported Event|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079430|NCT01464827|EG003|Reported Event|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
11079431|NCT01464827|EG004|Reported Event|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079432|NCT01464827|EG005|Reported Event|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079433|NCT01464827|EG006|Reported Event|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079434|NCT01464827|EG007|Reported Event|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
11079435|NCT01464827|EG008|Reported Event|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
11079436|NCT01464840|BG000|Baseline|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079437|NCT01464840|BG001|Baseline|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079438|NCT01464840|BG002|Baseline|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079439|NCT01464840|BG003|Baseline|Total|Total of all reporting groups
11079440|NCT01464840|FG000|Participant Flow|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079441|NCT01464840|FG001|Participant Flow|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079442|NCT01464840|FG002|Participant Flow|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079443|NCT01464840|OG000|Outcome|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079444|NCT01464840|OG001|Outcome|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079445|NCT01464840|OG002|Outcome|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079446|NCT01464840|EG000|Reported Event|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079447|NCT01464840|EG001|Reported Event|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079448|NCT01464840|EG002|Reported Event|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
11079449|NCT01464879|BG000|Baseline|Testosterone Topical|Initially study subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, study subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
11079450|NCT01464879|FG000|Participant Flow|Testosterone Topical|Initially subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
11079451|NCT01464879|OG000|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
11079452|NCT01464879|OG001|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
11079453|NCT01464879|OG002|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
11079454|NCT01464879|OG000|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
11079455|NCT01464879|EG000|Reported Event|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
11079456|NCT01464879|EG001|Reported Event|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
11079457|NCT01464879|EG002|Reported Event|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
11079458|NCT01464879|EG003|Reported Event|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
11079459|NCT01464931|BG000|Baseline|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079460|NCT01464931|BG001|Baseline|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079461|NCT01464931|BG002|Baseline|Total|Total of all reporting groups
11079462|NCT01464931|FG000|Participant Flow|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079463|NCT01464931|FG001|Participant Flow|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079464|NCT01464931|OG000|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079465|NCT01464931|OG001|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079466|NCT01464931|OG000|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
11079467|NCT01464931|OG001|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
11079468|NCT01464931|OG002|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
11079469|NCT01464931|OG003|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
11079470|NCT01464931|OG000|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
11079471|NCT01464931|OG001|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
11079472|NCT01464931|EG000|Reported Event|Denosumab 120 mg - Severe|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079473|NCT01464931|EG001|Reported Event|Denosumab 120 mg - ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079474|NCT01464931|EG002|Reported Event|Denosumab 120 mg - All Subjects|Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
11079475|NCT01464996|BG000|Baseline|All Study Participants|Will include composite restorations placed using both dental adhesives OptiBond XTR and OptiBond FL.
11079476|NCT01464996|FG000|Participant Flow|All Study Participants|"Will include composite restorations placed using both the dental adhesive OptiBond XTR and OptiBond FL.~Participants were randomized to receive either type of intervention"
11079477|NCT01464996|OG000|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
11079478|NCT01464996|OG001|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
11091898|NCT01536704|OG001|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
11079479|NCT01464996|EG000|Reported Event|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
11079480|NCT01464996|EG001|Reported Event|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
11079481|NCT01465022|BG000|Baseline|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions (OCP).
11079482|NCT01465022|BG001|Baseline|Progestin-only Pill|Study Arm B is one of two interventions (POP).
11079483|NCT01465022|BG002|Baseline|Not Randomized|70 women who were enrolled.
11079484|NCT01465022|BG003|Baseline|Total|Total of all reporting groups
11079485|NCT01465022|FG000|Participant Flow|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions.
11079486|NCT01465022|FG001|Participant Flow|Progestin-only Pill|Study Arm B is one of two interventions.
11079487|NCT01465022|FG002|Participant Flow|Not Randomized|Participants who were consented but not randomized.
11079488|NCT01465022|OG000|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
11079489|NCT01465022|OG001|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
11079490|NCT01465022|EG000|Reported Event|Combined Estrogin-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
11079491|NCT01465022|EG001|Reported Event|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
11173671|NCT02016885|BG003|Baseline|Glycopyrrolate, 4.0%|glycopyrrolate Topical Wipes, 4.0%
11079492|NCT01465048|BG000|Baseline|PfSPZ Challenge 2,500 ID|
11079493|NCT01465048|BG001|Baseline|PfSPZ Challenge 2,500 IM|
11079494|NCT01465048|BG002|Baseline|PfSPZ Challenge 25,000 IM|
11079495|NCT01465048|BG003|Baseline|Total|Total of all reporting groups
11079496|NCT01465048|FG000|Participant Flow|PfSPZ Challenge 2,500 ID|
11079497|NCT01465048|FG001|Participant Flow|PfSPZ Challenge 2,500 IM|
11079498|NCT01465048|FG002|Participant Flow|PfSPZ Challenge 25,000 IM|
11079499|NCT01465048|OG000|Outcome|PfSPZ Challenge 2,500 ID|
11079500|NCT01465048|OG001|Outcome|PfSPZ Challenge 2,500 IM|
11079501|NCT01465048|OG002|Outcome|PfSPZ Challenge 25,000 IM|
11079502|NCT01465048|EG000|Reported Event|PfSPZ Challenge 2,500 ID|
11079503|NCT01465048|EG001|Reported Event|PfSPZ Challenge 2,500 IM|
11079504|NCT01465048|EG002|Reported Event|PfSPZ Challenge 25,000 IM|
11079505|NCT01465178|BG000|Baseline|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
11079506|NCT01465178|BG001|Baseline|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
11079507|NCT01465178|BG002|Baseline|Total|Total of all reporting groups
11079508|NCT01465178|FG000|Participant Flow|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
11079509|NCT01465178|FG001|Participant Flow|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
11079510|NCT01465178|OG000|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
11079511|NCT01465178|OG001|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
11079512|NCT01465178|EG000|Reported Event|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
11079513|NCT01465178|EG001|Reported Event|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
11079514|NCT01465191|BG000|Baseline|50 Micrograms Spinal Morphine|these subjects will receive 50 mcg spinal morphine
11079515|NCT01465191|BG001|Baseline|100 Micrograms Spinal Morphine|these subjects will receive 100 mcg spinal morphine
11079516|NCT01465191|BG002|Baseline|150 Micrograms Spinal Morphine|these subjects will receive 150 mcg spinal morphine
11079517|NCT01465191|BG003|Baseline|Total|Total of all reporting groups
11079518|NCT01465191|FG000|Participant Flow|50 Micrograms Spinal Morphine|"Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed."
11079519|NCT01465191|FG001|Participant Flow|100 mcg Spinal Morphine|"Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed."
11079520|NCT01465191|FG002|Participant Flow|150 mcg Spinal Morphine|"Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed."
11079521|NCT01465191|OG000|Outcome|50 Micrograms Spinal Morphine|"Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section"
11079522|NCT01465191|OG001|Outcome|100 Micrograms Spinal Morphine|"Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section"
11079523|NCT01465191|OG002|Outcome|150 Micrograms Spinal Morphine|"Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section"
11173672|NCT02016885|BG004|Baseline|Vehicle|Vehicle Topical Wipes
11079524|NCT01465191|OG000|Outcome|50 Micrograms Spinal Morphine|"Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed."
11079525|NCT01465191|OG001|Outcome|100 Micrograms Spinal Morphine|"Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed."
11079526|NCT01465191|OG002|Outcome|150 Micrograms Spinal Morphine|"Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed."
11079527|NCT01465191|EG000|Reported Event|50 Micrograms Spinal Morphine|"Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed and analyzed with 47 in this group"
11079528|NCT01465191|EG001|Reported Event|100 Micrograms Spinal Morphine|"Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed and analyzed with 54 in this group"
11079529|NCT01465191|EG002|Reported Event|150 Micrograms Spinal Morphine|"Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section~Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section~After interim analysis, the genetics part of the analysis was dropped and the study completed and analyzed with 43 in this group"
11079530|NCT01465347|BG000|Baseline|TSC 0.25 mg/kg for 9 or 18 Doses|Trans Sodium Crocetinate (TSC): TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
11079531|NCT01465347|FG000|Participant Flow|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
11079532|NCT01465347|FG001|Participant Flow|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
11079533|NCT01465347|OG000|Outcome|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
11079534|NCT01465347|OG001|Outcome|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
11079535|NCT01465347|OG000|Outcome|TSC 0.25 mg/kg - 18 Dose Group - Phase 2|Trans Sodium Crocetinate (TSC): TSC administered intravenously for 18 doses as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
11079536|NCT01465347|OG000|Outcome|TSC 0.25mg/kg - 9 Dose Group - Phase 1|Phase 1 was the safety lead-in portion of the study conducted to evaluate an initial TSC dosage regimen in a smaller number of subjects and for a shorter period before a larger number of subjects were studied for a longer period in phase 2. Three (3) subjects were dosed with TSC at 0.25mg/kg for 3 weeks for a total of 9 doses with monitoring for dose-limiting toxicity (DLT). A Safety Monitoring Committee (SMC) evaluated the safety data and recommended TSC 0.25mg/kg for phase 2.
11079537|NCT01465347|OG001|Outcome|TSC 0.25 mg/kg - 18 Dose Group - Phase 2|Trans Sodium Crocetinate (TSC): TSC administered intravenously for 18 doses as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
11079538|NCT01465347|EG000|Reported Event|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
11079539|NCT01465347|EG001|Reported Event|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
11079540|NCT01465386|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
11079541|NCT01465386|FG000|Participant Flow|Treated Patients|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
11079542|NCT01465386|OG000|Outcome|Treated Patients|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
11079543|NCT01465386|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
11079544|NCT01465412|BG000|Baseline|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
11079545|NCT01465412|BG001|Baseline|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
11079546|NCT01465412|BG002|Baseline|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
11079547|NCT01465412|BG003|Baseline|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
11079548|NCT01465412|BG004|Baseline|Total|Total of all reporting groups
11079549|NCT01465412|FG000|Participant Flow|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
11079550|NCT01465412|FG001|Participant Flow|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
11079551|NCT01465412|FG002|Participant Flow|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
11079552|NCT01465412|FG003|Participant Flow|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
11079553|NCT01465412|OG000|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
11079554|NCT01465412|OG001|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
11079555|NCT01465412|OG002|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
11079556|NCT01465412|OG003|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
11079557|NCT01465412|EG000|Reported Event|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
11079558|NCT01465412|EG001|Reported Event|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
11079559|NCT01465412|EG002|Reported Event|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
11079560|NCT01465412|EG003|Reported Event|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
11079561|NCT01465464|BG000|Baseline|Orantinib|Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
11079562|NCT01465464|BG001|Baseline|Placebo|Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
11079563|NCT01465464|BG002|Baseline|Total|Total of all reporting groups
11079564|NCT01465464|FG000|Participant Flow|Orantinib|Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
11079565|NCT01465464|FG001|Participant Flow|Placebo|Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
11079566|NCT01465464|OG000|Outcome|Orantinib|Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
11079567|NCT01465464|OG001|Outcome|Placebo|Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
11079568|NCT01465464|EG000|Reported Event|Orantinib|Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
11079569|NCT01465464|EG001|Reported Event|Placebo|Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
11079570|NCT01465659|BG000|Baseline|Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg|"Temozolomide 150 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079571|NCT01465659|BG001|Baseline|Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg|"Temozolomide 100 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079572|NCT01465659|BG002|Baseline|Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079573|NCT01465659|BG003|Baseline|Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079574|NCT01465659|BG004|Baseline|Total|Total of all reporting groups
11079575|NCT01465659|FG000|Participant Flow|Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg|"Temozolomide 150 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079576|NCT01465659|FG001|Participant Flow|Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg|"Temozolomide 100 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079577|NCT01465659|FG002|Participant Flow|Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079578|NCT01465659|FG003|Participant Flow|Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079579|NCT01465659|OG000|Outcome|Cohort 1/Cohort -1/Cohort -2 - Temozolomide and Pazopanib|"Temozolomide 75 - 150 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079580|NCT01465659|OG000|Outcome|Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079581|NCT01465659|OG000|Outcome|Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg|"Temozolomide 150 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079582|NCT01465659|OG001|Outcome|Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg|"Temozolomide 100 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079583|NCT01465659|OG002|Outcome|Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079584|NCT01465659|OG003|Outcome|Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079585|NCT01465659|OG000|Outcome|Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079586|NCT01465659|EG000|Reported Event|Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg|"Temozolomide 150 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079587|NCT01465659|EG001|Reported Event|Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg|"Temozolomide 100 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079588|NCT01465659|EG002|Reported Event|Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079589|NCT01465659|EG003|Reported Event|Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg|"Temozolomide 75mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28~temozolomide: Given PO~pazopanib hydrochloride: Given PO"
11079590|NCT01465763|BG000|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
11079591|NCT01465763|BG001|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
11079592|NCT01465763|BG002|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
11079593|NCT01465763|BG003|Baseline|Total|Total of all reporting groups
11079594|NCT01465763|FG000|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
11079595|NCT01465763|FG001|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
11079596|NCT01465763|FG002|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
11079597|NCT01465763|OG000|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
11079598|NCT01465763|OG001|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
11079599|NCT01465763|EG000|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
11079600|NCT01465763|EG001|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
11079601|NCT01465763|EG002|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
11079602|NCT01465802|BG000|Baseline|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
11079603|NCT01465802|BG001|Baseline|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
11079604|NCT01465802|BG002|Baseline|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
11079605|NCT01465802|BG003|Baseline|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
11079606|NCT01465802|BG004|Baseline|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
11079607|NCT01465802|BG005|Baseline|Total|Total of all reporting groups
11173673|NCT02016885|BG005|Baseline|Total|Total of all reporting groups
11079608|NCT01465802|FG000|Participant Flow|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
11079609|NCT01465802|FG001|Participant Flow|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
11091899|NCT01536704|OG002|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
11079610|NCT01465802|FG002|Participant Flow|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
11079611|NCT01465802|FG003|Participant Flow|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
11079612|NCT01465802|FG004|Participant Flow|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
11079613|NCT01465802|OG000|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
11079614|NCT01465802|OG001|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
11079615|NCT01465802|OG002|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
11079616|NCT01465802|OG000|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
11079617|NCT01465802|OG003|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
10851382|NCT00306202|BG002|Baseline|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
11079618|NCT01465802|OG004|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
11079619|NCT01465802|OG000|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
11079620|NCT01465802|EG000|Reported Event|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
11079621|NCT01465802|EG001|Reported Event|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
11079622|NCT01465802|EG002|Reported Event|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
11079623|NCT01465802|EG003|Reported Event|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
11091900|NCT01536704|OG003|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
10851383|NCT00306202|BG003|Baseline|Total|Total of all reporting groups
11227497|NCT02383472|FG001|Participant Flow|MedX Health Console Model 1100-placebo|"Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective."
11227498|NCT02383472|OG000|Outcome|MedX Health Console Model 1100|"The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches. Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line"
11227499|NCT02383472|OG001|Outcome|MedX Health Console Model 1100-placebo|"Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective."
11227500|NCT02383472|OG000|Outcome|MedX Health Console Model 1100|"The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches. Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar"
11227501|NCT02383472|OG001|Outcome|MedX Health Console Model 1100-placebo|"Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r"
10851384|NCT00306202|FG000|Participant Flow|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained.
11079624|NCT01465802|EG004|Reported Event|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
11173674|NCT02016885|FG000|Participant Flow|Glycopyrrolate, 1.0%|glycopyrrolate Topical Wipes, 1.0%
11173675|NCT02016885|FG001|Participant Flow|Glycopyrrolate, 2.0%|glycopyrrolate Topical Wipes, 2.0%
11173676|NCT02016885|FG002|Participant Flow|Glycopyrrolate, 3.0%|glycopyrrolate Topical Wipes, 3.0%
11173677|NCT02016885|FG003|Participant Flow|Glycopyrrolate, 4.0%|glycopyrrolate Topical Wipes, 4.0%
11173678|NCT02016885|FG004|Participant Flow|Vehicle|Vehicle Topical Wipes
11173679|NCT02016885|OG000|Outcome|Glycopyrrolate, 1.0%|glycopyrrolate Topical Wipes, 1.0%
11173680|NCT02016885|OG001|Outcome|Glycopyrrolate, 2.0%|glycopyrrolate Topical Wipes, 2.0%
11173681|NCT02016885|OG002|Outcome|Glycopyrrolate, 3.0%|glycopyrrolate Topical Wipes, 3.0%
11173682|NCT02016885|OG003|Outcome|Glycopyrrolate, 4.0%|glycopyrrolate Topical Wipes, 4.0%
11173683|NCT02016885|OG004|Outcome|Vehicle|Vehicle Topical Wipes
11173684|NCT02016885|EG000|Reported Event|Glycopyrrolate, 1.0%|glycopyrrolate Topical Wipes, 1.0%
11173685|NCT02016885|EG001|Reported Event|Glycopyrrolate, 2.0%|glycopyrrolate Topical Wipes, 2.0%
11173686|NCT02016885|EG002|Reported Event|Glycopyrrolate, 3.0%|glycopyrrolate Topical Wipes, 3.0%
11173687|NCT02016885|EG003|Reported Event|Glycopyrrolate, 4.0%|glycopyrrolate Topical Wipes, 4.0%
11173688|NCT02016885|EG004|Reported Event|Vehicle|Vehicle Topical Wipes
11079625|NCT01465841|BG000|Baseline|Embolization With the PC 400 Coils|PC 400 coils (Penumbra ): The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.
11079626|NCT01465841|FG000|Participant Flow|Embolization With the PC 400 Coils|PC 400 coils (Penumbra ): The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.
11079627|NCT01465841|OG000|Outcome|Embolization With the PC 400 Coils|PC 400 coils (Penumbra ): The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.
11079628|NCT01465841|EG000|Reported Event|Embolization With the PC 400 Coils|PC 400 coils (Penumbra ): The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.
11079629|NCT01465958|BG000|Baseline|Safety Population|The safety population consisted of all subjects who received any amount of GAMUNEX-C. In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks. In the SC Phase, subjects received weekly subcutaneous infusion of Gamunex-C at a mg/kg dose based on intravenous dose of the subject and dosing interval x 1.37 conversion factor for 12 weeks.
11079630|NCT01465958|FG000|Participant Flow|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
11079631|NCT01465958|FG001|Participant Flow|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose of subject and dosing interval x 1.37 conversion factor for 12 weeks.
11079632|NCT01465958|OG000|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: In the IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
11079633|NCT01465958|OG001|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
11079634|NCT01465958|OG000|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: Two intravenous infusions at a dose of 200-600 mg/kg per intravenous infusion every 3-4 weeks for 4 to 5 weeks.
11079635|NCT01465958|EG000|Reported Event|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
11079636|NCT01465958|EG001|Reported Event|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
11079637|NCT01465997|BG000|Baseline|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
11079638|NCT01465997|BG001|Baseline|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
11079639|NCT01465997|BG002|Baseline|Total Title|
11079640|NCT01465997|FG000|Participant Flow|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
11079641|NCT01465997|FG001|Participant Flow|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
11079642|NCT01465997|OG000|Outcome|Lacosamide (SS)|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
11079643|NCT01465997|OG001|Outcome|Carbamazepine-Controlled Release (CBZ-CR) (SS)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
11079644|NCT01465997|OG000|Outcome|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
11079645|NCT01465997|OG001|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
11079646|NCT01465997|EG000|Reported Event|Lacosamide (SS)|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
11079647|NCT01465997|EG001|Reported Event|Carbamazepine-Controlled Release (CBZ-CR) (SS)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
11079648|NCT01466062|BG000|Baseline|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
11079649|NCT01466062|FG000|Participant Flow|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
11079650|NCT01466062|OG000|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
11079651|NCT01466062|EG000|Reported Event|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
11079652|NCT01466075|BG000|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
11079653|NCT01466075|FG000|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
11079654|NCT01466075|OG000|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
11079655|NCT01466075|EG000|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
11079656|NCT01466127|BG000|Baseline|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
11079657|NCT01466127|BG001|Baseline|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
11079658|NCT01466127|BG002|Baseline|Total|Total of all reporting groups
11079659|NCT01466127|FG000|Participant Flow|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
11079660|NCT01466127|FG001|Participant Flow|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
11079661|NCT01466127|OG000|Outcome|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
11079662|NCT01466127|OG001|Outcome|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
11079663|NCT01466127|EG000|Reported Event|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
11079664|NCT01466127|EG001|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
11079665|NCT01466153|BG000|Baseline|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
11079666|NCT01466153|BG001|Baseline|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079667|NCT01466153|BG002|Baseline|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079668|NCT01466153|BG003|Baseline|TOTAL|Total of all reporting groups
11079669|NCT01466153|FG000|Participant Flow|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
11079670|NCT01466153|FG001|Participant Flow|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079671|NCT01466153|FG002|Participant Flow|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079672|NCT01466153|OG000|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
11079673|NCT01466153|OG001|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079674|NCT01466153|OG002|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079675|NCT01466153|OG000|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079676|NCT01466153|OG001|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079677|NCT01466153|EG000|Reported Event|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
11079678|NCT01466153|EG001|Reported Event|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079679|NCT01466153|EG002|Reported Event|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
11079680|NCT01466166|BG000|Baseline|Pegloticase|Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.
11079681|NCT01466166|FG000|Participant Flow|Pegloticase|Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.
11079682|NCT01466166|OG000|Outcome|Pegloticase|Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.
11079683|NCT01466166|EG000|Reported Event|Pegloticase|Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.
11079684|NCT01466179|BG000|Baseline|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
11079685|NCT01466179|FG000|Participant Flow|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
11079686|NCT01466179|OG000|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
11079687|NCT01466179|OG000|Outcome|Cycle 1: Blinatumomab 9 μg/Day|Participants receiving 9 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
11079688|NCT01466179|OG001|Outcome|Cycle 1: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
11079689|NCT01466179|OG002|Outcome|Cycle 2: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 2.
11079690|NCT01466179|EG000|Reported Event|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The the initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
11079691|NCT01466192|BG000|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
11079692|NCT01466192|FG000|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
11079693|NCT01466192|OG000|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
11079694|NCT01466192|EG000|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
11079695|NCT01466270|BG000|Baseline|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
11079696|NCT01466270|BG001|Baseline|Arm II - Placebo|Patients receive placebo PO QD.
11079697|NCT01466270|BG002|Baseline|Total|Total of all reporting groups
11079698|NCT01466270|FG000|Participant Flow|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
11079699|NCT01466270|FG001|Participant Flow|Arm II - Placebo|Patients receive placebo PO QD.
11079700|NCT01466270|OG000|Outcome|Arm I|"Patients receive donepezil hydrochloride PO QD.~donepezil hydrochloride: Given PO"
11079701|NCT01466270|OG001|Outcome|Arm II|"Patients receive placebo PO QD.~Placebo: Given PO"
11079702|NCT01466270|OG000|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
11079703|NCT01466270|OG001|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
11233734|NCT02430870|OG004|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11079704|NCT01466270|EG000|Reported Event|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
11079705|NCT01466270|EG001|Reported Event|Arm II - Placebo|Patients receive placebo PO QD.
11079706|NCT01466348|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
11079707|NCT01466348|FG000|Participant Flow|Paracetamol/ Caffeine Tablet Then Paracetamol Powder|Participants were orally administered with 200 millilitre (mL) solution of two soluble tablets, [each tablet containing 500 milligram (mg) paracetamol and 65 mg of caffeine], then 200 mL solution of paracetamol soluble powder (1000 mg). A washout period of 5 hours was maintained.
11079708|NCT01466348|FG001|Participant Flow|Paracetamol Powder Then Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of paracetamol soluble powder (1000 mg), then 200 mL solution of two soluble tablets [each tablet containing 500 mg paracetamol and 65 mg of caffeine]. A washout period of 5 hours was maintained.
11079709|NCT01466348|OG000|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
11079710|NCT01466348|OG001|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
11079711|NCT01466348|OG000|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
11079712|NCT01466348|OG000|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
11079713|NCT01466348|EG000|Reported Event|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
11079714|NCT01466348|EG001|Reported Event|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
11079715|NCT01466361|BG000|Baseline|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
11079716|NCT01466361|BG001|Baseline|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
11079717|NCT01466361|BG002|Baseline|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
11079718|NCT01466361|BG003|Baseline|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
11079719|NCT01466361|BG004|Baseline|Total|Total of all reporting groups
11079720|NCT01466361|FG000|Participant Flow|Nicotine Lozenge 4 Milligrams (mg) (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
11079721|NCT01466361|FG001|Participant Flow|Placebo Lozenge (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
11079722|NCT01466361|FG002|Participant Flow|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
11079723|NCT01466361|FG003|Participant Flow|Placebo Lozenge (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
11079724|NCT01466361|OG000|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
11079725|NCT01466361|OG001|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
11079726|NCT01466361|OG000|Outcome|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
11079727|NCT01466361|OG001|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
11079728|NCT01466361|OG000|Outcome|Light Smokers Group|Participants smoking between 6-20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
11079729|NCT01466361|OG001|Outcome|Heavy Smokers Group|Participants smoking more than 20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
11233735|NCT02430870|EG000|Reported Event|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11079730|NCT01466361|OG000|Outcome|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
11079731|NCT01466361|OG002|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
11079732|NCT01466361|OG003|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
11079733|NCT01466361|EG000|Reported Event|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
11079734|NCT01466361|EG001|Reported Event|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
11079735|NCT01466361|EG002|Reported Event|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
11079736|NCT01466361|EG003|Reported Event|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
11079737|NCT01466387|BG000|Baseline|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
11079738|NCT01466387|BG001|Baseline|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
11079739|NCT01466387|BG002|Baseline|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
11079740|NCT01466387|BG003|Baseline|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
11079741|NCT01466387|BG004|Baseline|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
11079742|NCT01466387|BG005|Baseline|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
11079743|NCT01466387|BG006|Baseline|Total|Total of all reporting groups
11079744|NCT01466387|FG000|Participant Flow|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
11079745|NCT01466387|FG001|Participant Flow|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
11079746|NCT01466387|FG002|Participant Flow|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
11079747|NCT01466387|FG003|Participant Flow|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
11079748|NCT01466387|FG004|Participant Flow|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
11079749|NCT01466387|FG005|Participant Flow|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
11079750|NCT01466387|OG000|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
11079751|NCT01466387|OG001|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
11079752|NCT01466387|OG000|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
11079753|NCT01466387|OG001|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
11079754|NCT01466387|OG001|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
11079755|NCT01466387|OG001|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
11079756|NCT01466387|OG000|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
11079757|NCT01466387|OG000|Outcome|TF + YF + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
11079758|NCT01466387|OG001|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
11079759|NCT01466387|OG000|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
11079760|NCT01466387|OG000|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
11079761|NCT01466387|OG001|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of rabies vaccine.
11079762|NCT01466387|OG002|Outcome|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
11079763|NCT01466387|OG001|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
11079764|NCT01466387|OG002|Outcome|Rabies|Subjects ≥18 years to ≤60 yars of age who received three doses of Rabies vaccine.
11079765|NCT01466387|EG000|Reported Event|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
11079766|NCT01466387|EG001|Reported Event|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
11079767|NCT01466387|EG002|Reported Event|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
11079768|NCT01466387|EG003|Reported Event|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
11079769|NCT01466387|EG004|Reported Event|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
11079770|NCT01466387|EG005|Reported Event|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
11079771|NCT01466491|BG000|Baseline|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079772|NCT01466491|BG001|Baseline|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079773|NCT01466491|BG002|Baseline|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079774|NCT01466491|BG003|Baseline|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079775|NCT01466491|BG004|Baseline|Total|Total of all reporting groups
11079776|NCT01466491|FG000|Participant Flow|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079777|NCT01466491|FG001|Participant Flow|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079778|NCT01466491|FG002|Participant Flow|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11091901|NCT01536704|OG000|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11091902|NCT01536704|OG001|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11091903|NCT01536704|OG002|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11227502|NCT02383472|EG000|Reported Event|MedX Health Console Model 1100|"The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. All treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches. Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar"
11227503|NCT02383472|EG001|Reported Event|MedX Health Console Model 1100-placebo|"Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. All placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.~MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r"
11227504|NCT02383576|BG000|Baseline|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
11227505|NCT02383576|BG001|Baseline|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
11227506|NCT02383576|BG002|Baseline|Total|Total of all reporting groups
11227507|NCT02383576|FG000|Participant Flow|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
11227508|NCT02383576|FG001|Participant Flow|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
11227509|NCT02383576|OG000|Outcome|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
11227510|NCT02383576|OG001|Outcome|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
11227511|NCT02383576|EG000|Reported Event|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
11227512|NCT02383576|EG001|Reported Event|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
11227513|NCT02383589|BG000|Baseline|Rituximab (RTX)|Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
11227514|NCT02383589|BG001|Baseline|Mycophenolate Mofetil (MMF)|Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
11227515|NCT02383589|BG002|Baseline|Total|Total of all reporting groups
11227516|NCT02383589|FG000|Participant Flow|Rituximab (RTX)|Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
11227517|NCT02383589|FG001|Participant Flow|Mycophenolate Mofetil (MMF)|Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
11079779|NCT01466491|FG003|Participant Flow|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079780|NCT01466491|OG000|Outcome|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079781|NCT01466491|OG001|Outcome|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079782|NCT01466491|OG002|Outcome|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079783|NCT01466491|OG003|Outcome|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079784|NCT01466491|EG000|Reported Event|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079785|NCT01466491|EG001|Reported Event|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079786|NCT01466491|EG002|Reported Event|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11091904|NCT01536704|OG003|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11091905|NCT01536704|EG000|Reported Event|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11091906|NCT01536704|EG001|Reported Event|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
11079787|NCT01466491|EG003|Reported Event|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
11079788|NCT01466595|BG000|Baseline|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
11079789|NCT01466595|BG001|Baseline|Arm B: No Study Treatment|No study treatment for 4 weeks
11079790|NCT01466595|BG002|Baseline|Total|Total of all reporting groups
11079791|NCT01466595|FG000|Participant Flow|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
11079792|NCT01466595|FG001|Participant Flow|Arm B: No Study Treatment|No study treatment for 4 weeks
11079793|NCT01466595|OG000|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
11079794|NCT01466595|OG001|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
11079795|NCT01466595|EG000|Reported Event|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
11079796|NCT01466595|EG001|Reported Event|Arm B: No Study Treatment|No study treatment for 4 weeks
11079797|NCT01466660|BG000|Baseline|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal.
11079798|NCT01466660|BG001|Baseline|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal.
11079799|NCT01466660|BG002|Baseline|Total|Total of all reporting groups
11227518|NCT02383589|OG000|Outcome|Rituximab (RTX)|Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
11227519|NCT02383589|OG001|Outcome|Mycophenolate Mofetil (MMF)|Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
11227520|NCT02383589|EG000|Reported Event|Rituximab (RTX)|Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
11079800|NCT01466660|FG000|Participant Flow|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal.
11079801|NCT01466660|FG001|Participant Flow|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal.
11079802|NCT01466660|OG000|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal.
11079803|NCT01466660|OG001|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal.
11079804|NCT01466660|EG000|Reported Event|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal.
11079805|NCT01466660|EG001|Reported Event|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal.
11079806|NCT01466673|BG000|Baseline|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
11079807|NCT01466673|BG001|Baseline|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
11079808|NCT01466673|BG002|Baseline|Total|Total of all reporting groups
11079809|NCT01466673|FG000|Participant Flow|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
11079810|NCT01466673|FG001|Participant Flow|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
11079811|NCT01466673|OG000|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
11079812|NCT01466673|OG001|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
11079813|NCT01466673|EG000|Reported Event|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
11079814|NCT01466673|EG001|Reported Event|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
11079815|NCT01466751|BG000|Baseline|Engaging Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079816|NCT01466751|BG001|Baseline|Neurobehavioral Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079817|NCT01466751|BG002|Baseline|Total|Total of all reporting groups
11079818|NCT01466751|FG000|Participant Flow|Neurobehavioral Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11227521|NCT02383589|EG001|Reported Event|Mycophenolate Mofetil (MMF)|Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
11079819|NCT01466751|FG001|Participant Flow|Engaging Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079820|NCT01466751|OG000|Outcome|Engaging Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079821|NCT01466751|OG001|Outcome|Neurobehavioral Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079822|NCT01466751|OG000|Outcome|Neurobehavioral Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079823|NCT01466751|OG001|Outcome|Engaging Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079824|NCT01466751|EG000|Reported Event|Engaging Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079825|NCT01466751|EG001|Reported Event|Neurobehavioral Computerized Tasks|"Participants will log into a personalized website and engage in computerized tasks online.~Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."
11079826|NCT01466764|BG000|Baseline|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
11079827|NCT01466764|BG001|Baseline|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
11079828|NCT01466764|BG002|Baseline|Total|Total of all reporting groups
11079829|NCT01466764|FG000|Participant Flow|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
11079830|NCT01466764|FG001|Participant Flow|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
11079831|NCT01466764|OG000|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
11079832|NCT01466764|OG001|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
11079833|NCT01466764|EG000|Reported Event|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
11079834|NCT01466764|EG001|Reported Event|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
11079835|NCT01466790|BG000|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079836|NCT01466790|BG001|Baseline|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079837|NCT01466790|BG002|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079838|NCT01466790|BG003|Baseline|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079839|NCT01466790|BG004|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079840|NCT01466790|BG005|Baseline|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079841|NCT01466790|BG006|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079842|NCT01466790|BG007|Baseline|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079843|NCT01466790|BG008|Baseline|Total|Total of all reporting groups
11079844|NCT01466790|FG000|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079845|NCT01466790|FG001|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079846|NCT01466790|FG002|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079847|NCT01466790|FG003|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079848|NCT01466790|FG004|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079849|NCT01466790|FG005|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079850|NCT01466790|FG006|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079851|NCT01466790|FG007|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
11091907|NCT01536704|EG002|Reported Event|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
11079852|NCT01466790|OG000|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079853|NCT01466790|OG001|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079854|NCT01466790|OG002|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079855|NCT01466790|OG003|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079856|NCT01466790|OG004|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079857|NCT01466790|OG005|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079858|NCT01466790|OG006|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079859|NCT01466790|OG007|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079860|NCT01466790|EG000|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079861|NCT01466790|EG001|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
11079862|NCT01466790|EG002|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079863|NCT01466790|EG003|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
11079864|NCT01466881|BG000|Baseline|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
11079865|NCT01466881|FG000|Participant Flow|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
11079866|NCT01466881|OG000|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
11079867|NCT01466881|OG000|Outcome|Non-responders|Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.
11079868|NCT01466881|OG001|Outcome|Responders|Eligible Patients who received protocol treatment and achieved complete or partial response.
11079869|NCT01466881|EG000|Reported Event|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
11079870|NCT01466972|BG000|Baseline|Pazopanib in Combination With a NSAI|"Non-randomized, open label~Pazopanib: Oral, 800mg tablet daily per cycle"
11079871|NCT01466972|FG000|Participant Flow|Pazopanib in Combination With a NSAI|"Non-randomized, open label~Pazopanib: Oral, 800mg tablet daily per cycle"
11079872|NCT01466972|OG000|Outcome|Pazopanib in Combination With a NSAI|"Non-randomized, open label~Pazopanib: Oral, 800mg tablet daily per cycle"
11079873|NCT01466972|EG000|Reported Event|Pazopanib in Combination With a NSAI|"Non-randomized, open label~Pazopanib: Oral, 800mg tablet daily per cycle"
11079874|NCT01466985|BG000|Baseline|Doravirine 25 mg|Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
11079875|NCT01466985|BG001|Baseline|Doravirine 200 mg|Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
11079876|NCT01466985|BG002|Baseline|Placebo|Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
11079877|NCT01466985|BG003|Baseline|Total|Total of all reporting groups
11079878|NCT01466985|FG000|Participant Flow|Doravirine 25 mg|Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
11079879|NCT01466985|FG001|Participant Flow|Doravirine 200 mg|Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
11079880|NCT01466985|FG002|Participant Flow|Placebo|Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
11227522|NCT02383589|EG002|Reported Event|RTX Safety Follow-up|Participants, who received RTX in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.
11227523|NCT02383589|EG003|Reported Event|MMF Safety Follow-up|Participants, who received MMF in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.
11227524|NCT02383667|BG000|Baseline|Patients With Electrocardiograms|"Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.~One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.~Electrocardiogram holter"
11227525|NCT02383667|FG000|Participant Flow|Patients With Electrocardiograms|"Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.~One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.~Electrocardiogram holter"
11227526|NCT02383667|OG000|Outcome|Patients With Electrocardiograms|"Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.~One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.~Electrocardiogram holter"
11227527|NCT02383667|EG000|Reported Event|Patients With Electrocardiograms|"Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.~One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.~Electrocardiogram holter"
11227528|NCT02383706|BG000|Baseline|Subjects|"Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.~ApneaLink Air: Overnight, home polysomnography device~Berlin Quesionnaire: OSA screening questionnaire~Epworth Sleepiness Scale: OSA screening questionnaire~STOP-BANG questionnaire: OSA screening questionnaire~Physical exam: Physical exam of neck, mouth and upper airway"
11227529|NCT02383706|FG000|Participant Flow|Subjects|"Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.~ApneaLink Air: Overnight, home polysomnography device~Berlin Quesionnaire: OSA screening questionnaire~Epworth Sleepiness Scale: OSA screening questionnaire~STOP-BANG questionnaire: OSA screening questionnaire~Physical exam: Physical exam of neck, mouth and upper airway"
11227530|NCT02383706|OG000|Outcome|Subjects|"Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.~ApneaLink Air: Overnight, home polysomnography device Berlin Quesionnaire: OSA screening questionnaire Epworth Sleepiness Scale: OSA screening questionnaire STOP-BANG questionnaire: OSA screening questionnaire Physical exam: Physical exam of neck, mouth and upper airway"
11227531|NCT02383706|OG000|Outcome|Subjects|"Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.~ApneaLink Air: Overnight, home polysomnography device~Berlin Quesionnaire: OSA screening questionnaire~Epworth Sleepiness Scale: OSA screening questionnaire~STOP-BANG questionnaire: OSA screening questionnaire~Physical exam: Physical exam of neck, mouth and upper airway"
11227532|NCT02383706|EG000|Reported Event|Subjects|"Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.~ApneaLink Air: Overnight, home polysomnography device~Berlin Quesionnaire: OSA screening questionnaire~Epworth Sleepiness Scale: OSA screening questionnaire~STOP-BANG questionnaire: OSA screening questionnaire~Physical exam: Physical exam of neck, mouth and upper airway"
11227533|NCT02383719|BG000|Baseline|Oro-nasal Mask|Oro-nasal Mask
11227534|NCT02383719|FG000|Participant Flow|Oro-nasal Mask|Oro-nasal Mask
11227535|NCT02383719|OG000|Outcome|Oro-nasal Mask|All patients in this group received the experimental oro-nasal mask for evaluation of use. Patient's received non-invasive ventilation were switched to this mask upone study initiation.
11227536|NCT02383719|EG000|Reported Event|Oro-nasal Mask|Oro-nasal Mask
11227537|NCT02383758|BG000|Baseline|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
11227538|NCT02383758|BG001|Baseline|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
11227539|NCT02383758|BG002|Baseline|Total|Total of all reporting groups
11233736|NCT02430870|EG001|Reported Event|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11173689|NCT02016898|BG000|Baseline|Sponge Placement of Mitomycin-C|"Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
11173690|NCT02016898|BG001|Baseline|Irrigation Placement of Mitomycin-C|"Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
11173691|NCT02016898|BG002|Baseline|Total|Total of all reporting groups
11173692|NCT02016898|FG000|Participant Flow|Sponge Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
11173693|NCT02016898|FG001|Participant Flow|Irrigation Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
11173694|NCT02016898|OG000|Outcome|Sponge Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
11173695|NCT02016898|OG001|Outcome|Irrigation Placement of MMC|"Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
11173696|NCT02016898|EG000|Reported Event|Sponge Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
11173697|NCT02016898|EG001|Reported Event|Irrigation Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
11173698|NCT02016963|BG000|Baseline|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
11173699|NCT02016963|FG000|Participant Flow|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
11173700|NCT02016963|OG000|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
11173701|NCT02016963|OG000|Outcome|Raxibacumab IV|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
11173702|NCT02016963|EG000|Reported Event|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
11173703|NCT02017015|BG000|Baseline|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
11173704|NCT02017015|FG000|Participant Flow|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 by IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
11173705|NCT02017015|OG000|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
11173706|NCT02017015|OG000|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
11173707|NCT02017015|EG000|Reported Event|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
11173708|NCT02017093|BG000|Baseline|Study|Patients admitted to rehabilitation center after a stroke.
11173709|NCT02017093|BG001|Baseline|Control|Patients admitted to rehabilitation center after a stroke.
11173710|NCT02017093|BG002|Baseline|Total|Total of all reporting groups
11173711|NCT02017093|FG000|Participant Flow|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
11173712|NCT02017093|FG001|Participant Flow|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
11150343|NCT01877239|BG000|Baseline|Etanercept|Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
11150344|NCT01877239|FG000|Participant Flow|Etanercept|Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
11150345|NCT01877239|OG000|Outcome|Etanercept|Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
11150346|NCT01877239|EG000|Reported Event|Etanercept|Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
11150347|NCT01877265|BG000|Baseline|0.5 U/kg LY2605541|Participants randomized to receive a single, SC injection of 0.5 U/kg LY2605541 using 3 different PEG sources on Day 1 of each of 3 treatment periods, according to their assigned treatment sequence.
11150348|NCT01877265|FG000|Participant Flow|LY3/LY2/LY1|"A single, subcutaneous (SC) injection of 0.5 units per kilogram (U/kg) LY2605541 from Source 3 on Day 1 of Period 1; from Source 2 on Day 1 of Period 2; and from Source 1 on Day 1 of Period 3.~There was a washout period of at least 14 days between injections. Each participant received up to 3 injections."
11150349|NCT01877265|FG001|Participant Flow|LY2/LY1/LY3|"A single, SC injection of 0.5 U/kg LY2605541 from Source 2 on Day 1 of Period 1; from Source 1 on Day 1 of Period 2; and from Source 3 on Day 1 of Period 3.~There was a washout period of at least 14 days between injections. Each participant received up to 3 injections."
11150350|NCT01877265|FG002|Participant Flow|LY1/LY2/LY3|"A single, SC injection of 0.5 U/kg LY2605541 from Source 1 on Day 1 of Period 1; from Source 2 on Day 1 of Period 2; and from Source 3 on Day 1 of Period 3.~There was a washout period of at least 14 days between injections. Each participant received up to 3 injections."
11150351|NCT01877265|FG003|Participant Flow|LY1/LY3/LY2|"A single, SC injection of 0.5 U/kg LY2605541 from Source 1 on Day 1 of Period 1; from Source 3 on Day 1 of Period 2; and from Source 2 on Day 1 of Period 3.~There was a washout period of at least 14 days between injections. Each participant received up to 3 injections."
11150352|NCT01877265|FG004|Participant Flow|LY3/LY1/LY2|"A single, SC injection of 0.5 U/kg LY2605541 from Source 3 on Day 1 of Period 1; from Source 1 on Day 1 of Period 2; and from Source 2 on Day 1 of Period 3.~There was a washout period of at least 14 days between injections. Each participant received up to 3 injections."
11150353|NCT01877265|FG005|Participant Flow|LY2/LY3/LY1|"A single, SC injection of 0.5 U/kg LY2605541 from Source 2 on Day 1 of Period 1; from Source 3 on Day 1 of Period 2; and from Source 1 on Day 1 of Period 3.~There was a washout period of at least 14 days between injections. Each participant received up to 3 injections."
11150354|NCT01877265|OG000|Outcome|0.5 U/kg LY2605541 (LY1)|LY2605541: 0.5 U/kg SC injection, single dose from PEG source 1 (LY1) on Day 1 of 1 of the 3 treatment periods.
11150355|NCT01877265|OG001|Outcome|0.5 U/kg LY2605541 (LY2)|LY2605541: 0.5 U/kg SC injection, single dose from PEG source 2 (LY2) on Day 1 of 1 of the 3 treatment periods.
11150356|NCT01877265|OG002|Outcome|0.5 U/kg LY2605541 (LY3)|LY2605541: 0.5 U/kg SC injection, single dose from PEG source 3 (LY3) on Day 1 of 1 of the 3 treatment periods.
11150357|NCT01877265|OG000|Outcome|0.5 U/kg LY2605541 (LY1)|LY2605541: 0.5 U/kg SC injection, single dose from LY1 on Day 1 of 1 of the 3 treatment periods.
11150358|NCT01877265|OG001|Outcome|0.5 U/kg LY2605541 (LY2)|LY2605541: 0.5 U/kg SC injection, single dose from LY2 on Day 1 of 1 of the 3 treatment periods.
11150359|NCT01877265|OG002|Outcome|0.5 U/kg LY2605541 (LY3)|LY2605541: 0.5 U/kg SC injection, single dose from LY3 on Day 1 of 1 of the 3 treatment periods.
11150360|NCT01877265|EG000|Reported Event|0.5 U/kg LY2605541 (LY1)|LY2605541: 0.5 U/kg SC injection, single dose from LY1 on Day 1 of 1 of the 3 treatment periods.
11150361|NCT01877265|EG001|Reported Event|0.5 U/kg LY2605541 (LY2)|LY2605541: 0.5 U/kg SC injection, single dose from LY2 on Day 1 of 1 of the 3 treatment periods.
11150362|NCT01877265|EG002|Reported Event|0.5 U/kg LY2605541 (LY3)|LY2605541: 0.5 U/kg SC injection, single dose from LY3 on Day 1 of 1 of the 3 treatment periods.
11150363|NCT01877278|BG000|Baseline|Active|"emitting group~Wearable pulsed electromagnetic fields"
11150364|NCT01877278|BG001|Baseline|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
11150365|NCT01877278|BG002|Baseline|Total|Total of all reporting groups
11150366|NCT01877278|FG000|Participant Flow|Active|"emitting group~Wearable pulsed electromagnetic fields"
11150367|NCT01877278|FG001|Participant Flow|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
11150368|NCT01877278|OG000|Outcome|Active|"emitting group~Wearable pulsed electromagnetic fields"
11150369|NCT01877278|OG001|Outcome|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
11150370|NCT01877278|EG000|Reported Event|Active|"emitting group~Wearable pulsed electromagnetic fields"
11150371|NCT01877278|EG001|Reported Event|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
11150372|NCT01877408|BG000|Baseline|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
11150373|NCT01877408|BG001|Baseline|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
11150374|NCT01877408|BG002|Baseline|Total|Total of all reporting groups
11150375|NCT01877408|FG000|Participant Flow|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
11079881|NCT01466985|OG000|Outcome|Doravirine 25 mg|Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
11079882|NCT01466985|OG001|Outcome|Doravirine 200 mg|Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
11079883|NCT01466985|OG002|Outcome|Placebo|Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
11079884|NCT01466985|EG000|Reported Event|Doravirine 25 mg|Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
11079885|NCT01466985|EG001|Reported Event|Doravirine 200 mg|Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
11079886|NCT01466985|EG002|Reported Event|Placebo|Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
11079887|NCT01466985|EG003|Reported Event|Poststudy|AEs from all participants in the study were pooled for the poststudy period.
11079888|NCT01467037|BG000|Baseline|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
11079889|NCT01467037|BG001|Baseline|Rotavirus -Positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus-positives were confirmed via real-time reverse-transcriptase polymerase chain reactions (RT-PCR). RT-PCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
11079890|NCT01467037|BG002|Baseline|Total|Total of all reporting groups
11079891|NCT01467037|FG000|Participant Flow|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
11079892|NCT01467037|OG000|Outcome|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
11079893|NCT01467037|OG001|Outcome|Rotavirus-positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus positives were confirmed via realtime reversetranscriptase polymerase chain reactions (RTPCR). RTPCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
11079894|NCT01467037|OG000|Outcome|2 Versus 0 Doses|We compared Rotavirus VE between patients that received 2 versus 0 doses of RV1.
11079895|NCT01467037|OG001|Outcome|≥1 Versus 0 Dose|We compared Rotavirus VE between patients that received 1 versus 0 dose of RV1.
11079896|NCT01467037|EG000|Reported Event|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
11079897|NCT01467063|BG000|Baseline|All Participants|
11079898|NCT01467063|FG000|Participant Flow|Glutamine, Then Placebo|Thirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.
11079899|NCT01467063|FG001|Participant Flow|Placebo, Then Glutamine|Thirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.
11079900|NCT01467063|OG000|Outcome|Glutamine|Glutamine: Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a drink containing Glutamine (0.25 g/kg/dose). Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
11079901|NCT01467063|OG001|Outcome|Placebo|Placebo: Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a PLACEBO drink. Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
11079902|NCT01467063|EG000|Reported Event|Glutamine|Thirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.
11079903|NCT01467063|EG001|Reported Event|Placebo|Thirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.
11079904|NCT01467076|BG000|Baseline|Control|Aerosolized saline
11079905|NCT01467076|BG001|Baseline|Low Dose IPGE1|150 ng/kg/min
11079906|NCT01467076|BG002|Baseline|High Dose IPGE1|300 ng/kg/min
11079907|NCT01467076|BG003|Baseline|Total|Total of all reporting groups
11079908|NCT01467076|FG000|Participant Flow|Control|Aerosolized saline
11079909|NCT01467076|FG001|Participant Flow|Low Dose IPGE1|150 ng/kg/min
11079910|NCT01467076|FG002|Participant Flow|High Dose IPGE1|300 ng/kg/min
11079911|NCT01467076|OG000|Outcome|Control|Aerosolized saline
11079912|NCT01467076|OG001|Outcome|Low Dose IPGE1|150 ng/kg/min
11079913|NCT01467076|OG002|Outcome|High Dose IPGE1|300 ng/kg/min
11079914|NCT01467076|EG000|Reported Event|Control|Aerosolized saline
11079915|NCT01467076|EG001|Reported Event|Low Dose IPGE1|150 ng/kg/min
11079916|NCT01467076|EG002|Reported Event|High Dose IPGE1|300 ng/kg/min
11079917|NCT01467271|BG000|Baseline|Safety Population|The safety population included all patients receiving at least one injection of contrast media regardless of the quantity.
11079918|NCT01467271|FG000|Participant Flow|All Included Patients|All patients included in the study.
11079919|NCT01467271|OG000|Outcome|NSF Population|The NSF population included patients with the NSF follow-up questionnaire completed.
11079920|NCT01467271|EG000|Reported Event|Safety Population|The safety population included all patients receiving at least one injection of contrast media regardless of the quantity.
11079921|NCT01467427|BG000|Baseline|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
11079922|NCT01467427|BG001|Baseline|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
11079923|NCT01467427|BG002|Baseline|Total|Total of all reporting groups
11079924|NCT01467427|FG000|Participant Flow|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
11079925|NCT01467427|FG001|Participant Flow|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
11079926|NCT01467427|OG000|Outcome|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
11079927|NCT01467427|OG001|Outcome|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
11079928|NCT01467427|EG000|Reported Event|Younger Children (0 - 6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
11079929|NCT01467427|EG001|Reported Event|Older Children (7 - 12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
11079930|NCT01467466|BG000|Baseline|Saline & Oral Placebo|"IV isotonic saline and oral placebo drug capsule~IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079931|NCT01467466|BG001|Baseline|Saline & Oral N-acetylcysteine|"IV isotonic saline and oral N-acetylcysteine drug capsule~IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079932|NCT01467466|BG002|Baseline|Bicarbonate & Oral Placebo|"IV isotonic bicarbonate and oral placebo drug capsule~IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079933|NCT01467466|BG003|Baseline|Bicarbonate & Oral N-acetylcysteine|"IV isotonic bicarbonate and oral N-acetylcysteine drug capsule~IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079934|NCT01467466|BG004|Baseline|Total|Total of all reporting groups
11079935|NCT01467466|FG000|Participant Flow|Saline & Oral Placebo|"IV isotonic saline and oral placebo drug capsule~IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079936|NCT01467466|FG001|Participant Flow|Saline & Oral N-acetylcysteine|"IV isotonic saline and oral N-acetylcysteine (NAC) drug capsule~IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079937|NCT01467466|FG002|Participant Flow|Bicarbonate & Oral Placebo|"IV isotonic bicarbonate and oral placebo drug capsule~IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079938|NCT01467466|FG003|Participant Flow|Bicarbonate & Oral N-acetylcysteine|"IV isotonic bicarbonate and oral N-acetylcysteine drug capsule~IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079939|NCT01467466|OG000|Outcome|Sodium Bicarbonate|A grouping of participants receiving Sodium Bicarbonate.
11079940|NCT01467466|OG001|Outcome|Saline|A grouping of participants receiving Saline.
11079941|NCT01467466|OG000|Outcome|N-Acetylcysteine (NAC)|A grouping of participants receiving NAC.
11079942|NCT01467466|OG001|Outcome|Placebo|A grouping of participants receiving placebo.
11079943|NCT01467466|EG000|Reported Event|IV Isotonic Saline & Oral Placebo|"IV isotonic saline and oral placebo drug capsule~IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079944|NCT01467466|EG001|Reported Event|IV Isotonic Saline & Oral N-acetylcysteine|"IV isotonic saline and oral N-acetylcysteine drug capsule~IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079945|NCT01467466|EG002|Reported Event|IV Isotonic Bicarbonate & Oral Placebo|"IV isotonic bicarbonate and oral placebo drug capsule~IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11091908|NCT01536704|EG003|Reported Event|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
11233737|NCT02430870|EG002|Reported Event|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
11079946|NCT01467466|EG003|Reported Event|IV Isotonic Bicarbonate & Oral N-acetylcysteine|"IV isotonic bicarbonate and oral N-acetylcysteine drug capsule~IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.~N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days."
11079947|NCT01467479|BG000|Baseline|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079948|NCT01467479|BG001|Baseline|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079949|NCT01467479|BG002|Baseline|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079950|NCT01467479|BG003|Baseline|Total|Total of all reporting groups
11079951|NCT01467479|FG000|Participant Flow|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079952|NCT01467479|FG001|Participant Flow|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079953|NCT01467479|FG002|Participant Flow|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079954|NCT01467479|OG000|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079955|NCT01467479|OG001|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079956|NCT01467479|OG002|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079957|NCT01467479|OG000|Outcome|T/PR + HAART Regimen|Participants who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their respective HAART, as per standard practice and investigator discretion.
11079958|NCT01467479|EG000|Reported Event|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079959|NCT01467479|EG001|Reported Event|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11091909|NCT01536795|BG000|Baseline|WR279,396 With Tegaderm Dressing|"24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing~WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing"
11079960|NCT01467479|EG002|Reported Event|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
11079961|NCT01467492|BG000|Baseline|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079962|NCT01467492|BG001|Baseline|Group B - Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079963|NCT01467492|BG002|Baseline|Total|Total of all reporting groups
11079964|NCT01467492|FG000|Participant Flow|Group A - Black|Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079965|NCT01467492|FG001|Participant Flow|Group B - Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079966|NCT01467492|OG000|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079967|NCT01467492|OG001|Outcome|Group B - Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079968|NCT01467492|OG000|Outcome|All Participants|All enrolled participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079969|NCT01467492|EG000|Reported Event|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079970|NCT01467492|EG001|Reported Event|Group B - Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
11079971|NCT01467505|BG000|Baseline|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
11079972|NCT01467505|BG001|Baseline|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
11079973|NCT01467505|BG002|Baseline|Total|Total of all reporting groups
11079974|NCT01467505|FG000|Participant Flow|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
11079975|NCT01467505|FG001|Participant Flow|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
11079976|NCT01467505|OG000|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
11079977|NCT01467505|OG001|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
11079978|NCT01467505|EG000|Reported Event|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
11079979|NCT01467505|EG001|Reported Event|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
11079980|NCT01467557|BG000|Baseline|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
11079981|NCT01467557|BG001|Baseline|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
11079982|NCT01467557|BG002|Baseline|Total|Total of all reporting groups
11079983|NCT01467557|FG000|Participant Flow|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
11079984|NCT01467557|FG001|Participant Flow|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
11079985|NCT01467557|OG000|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
11079986|NCT01467557|OG001|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
11079987|NCT01467557|EG000|Reported Event|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
11079988|NCT01467557|EG001|Reported Event|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
11079989|NCT01467570|BG000|Baseline|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079990|NCT01467570|BG001|Baseline|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079991|NCT01467570|BG002|Baseline|Total|Total of all reporting groups
11079992|NCT01467570|FG000|Participant Flow|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079993|NCT01467570|FG001|Participant Flow|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079994|NCT01467570|OG000|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079995|NCT01467570|OG001|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079996|NCT01467570|OG000|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079997|NCT01467570|OG001|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079998|NCT01467570|EG000|Reported Event|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11079999|NCT01467570|EG001|Reported Event|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
11080000|NCT01467583|BG000|Baseline|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
11080001|NCT01467583|BG001|Baseline|Renal Failure, on CRRT|Fondaparinux: 2.5 mg every 48 hours
11080002|NCT01467583|BG002|Baseline|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
11080003|NCT01467583|BG003|Baseline|Total|Total of all reporting groups
11080004|NCT01467583|FG000|Participant Flow|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
11080005|NCT01467583|FG001|Participant Flow|Renal Failure, on CRRT on Fondaparinux: 2.5 mg Every 48 Hours|These are renal failure patients, either acute or chronic on Fondaparinux: 2.5 mg every 48 hours
11080006|NCT01467583|FG002|Participant Flow|Renal Failure, Not on Dialysis Fondaparinux: 2.5 mg q48 hr|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
11080007|NCT01467583|OG000|Outcome|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
11080008|NCT01467583|OG001|Outcome|Renal Failure-continuous Renal Replacement Therapy|These are renal failure patients, either acute or chronic, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
11080009|NCT01467583|OG002|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
11080010|NCT01467583|OG000|Outcome|Renal Failure on Intermittent Dialysis (IHD)|"These are patients with renal failure, on IHD, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
11080011|NCT01467583|OG001|Outcome|Renal Failure-renal Replacement Therapy|"These are patients with renal failure, either acute or chronic, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
11080012|NCT01467583|OG002|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
11080013|NCT01467583|EG000|Reported Event|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
11080014|NCT01467583|EG001|Reported Event|Renal Failure-continuous Renal Replacement Therapy|These are patients with renal failure, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
11080015|NCT01467583|EG002|Reported Event|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
11080016|NCT01467661|BG000|Baseline|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
11080017|NCT01467661|FG000|Participant Flow|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
11080018|NCT01467661|OG000|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
11080019|NCT01467661|OG000|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
11080020|NCT01467661|EG000|Reported Event|SPD422: Safety Analysis Set|Included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
11080021|NCT01467661|EG001|Reported Event|SPD422: Post-marketing Trial Safety Analysis Set|Included all subjects in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
11080022|NCT01467700|BG000|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
11080023|NCT01467700|BG001|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
11080024|NCT01467700|BG002|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
11080025|NCT01467700|BG003|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
11080026|NCT01467700|BG004|Baseline|Total|Total of all reporting groups
11080027|NCT01467700|FG000|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
11080028|NCT01467700|FG001|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
11080029|NCT01467700|FG002|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
11080030|NCT01467700|FG003|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
11080031|NCT01467700|OG000|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
11080032|NCT01467700|OG001|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
11080033|NCT01467700|OG002|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
11080034|NCT01467700|OG003|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
11080035|NCT01467700|EG000|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
11080036|NCT01467700|EG001|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
11080037|NCT01467700|EG002|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
11080038|NCT01467700|EG003|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
11080039|NCT01467713|BG000|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
11080040|NCT01467713|BG001|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080041|NCT01467713|BG002|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080042|NCT01467713|BG003|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080043|NCT01467713|BG004|Baseline|Total|Total of all reporting groups
11080044|NCT01467713|FG000|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
11080045|NCT01467713|FG001|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080046|NCT01467713|FG002|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080047|NCT01467713|FG003|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080048|NCT01467713|OG000|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
11080049|NCT01467713|OG001|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080050|NCT01467713|OG002|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080051|NCT01467713|OG003|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080052|NCT01467713|EG000|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
11080053|NCT01467713|EG001|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080054|NCT01467713|EG002|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080055|NCT01467713|EG003|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
11080056|NCT01467882|BG000|Baseline|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080057|NCT01467882|FG000|Participant Flow|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080058|NCT01467882|OG000|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080059|NCT01467882|OG000|Outcome|All Children Luteinizing Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080060|NCT01467882|OG001|Outcome|All Children Follicle Stimulating Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080061|NCT01467882|OG000|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080062|NCT01467882|OG000|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080063|NCT01467882|OG001|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080064|NCT01467882|OG002|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080065|NCT01467882|OG000|Outcome|AOC Subset|All children in AOC subset who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080066|NCT01467882|EG000|Reported Event|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
11080067|NCT01467934|BG000|Baseline|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
11080068|NCT01467934|BG001|Baseline|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
11080069|NCT01467934|BG002|Baseline|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
11080070|NCT01467934|BG003|Baseline|Total|Total of all reporting groups
11080071|NCT01467934|FG000|Participant Flow|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine 0.25ml IM X 1
11080072|NCT01467934|FG001|Participant Flow|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
11080073|NCT01467934|FG002|Participant Flow|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1
11080074|NCT01467934|OG000|Outcome|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
11080075|NCT01467934|OG001|Outcome|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
11080076|NCT01467934|OG002|Outcome|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
11080077|NCT01467934|EG000|Reported Event|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
11080078|NCT01467934|EG001|Reported Event|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
11080079|NCT01467934|EG002|Reported Event|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
11080080|NCT01467947|BG000|Baseline|C1 Esterase Inhibitor|Subjects received 20 IU/kg C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
11080081|NCT01467947|FG000|Participant Flow|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
11080082|NCT01467947|OG000|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
11080083|NCT01467947|EG000|Reported Event|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
11080084|NCT01467960|BG000|Baseline|Group I|Healthy Subjects aged 20-40
11080085|NCT01467960|BG001|Baseline|Group II|Healthy Subjects aged 40-65
11080086|NCT01467960|BG002|Baseline|Group III|Healthy Subjects aged more than 65
11080087|NCT01467960|BG003|Baseline|Group A|Patients at Stage I, H&Y
11080088|NCT01467960|BG004|Baseline|Group B|Patients at Stage II, H&Y
11080089|NCT01467960|BG005|Baseline|Group C|Patients at stage > than II, H&Y
11080090|NCT01467960|BG006|Baseline|Total|Total of all reporting groups
11080091|NCT01467960|FG000|Participant Flow|Group I|30 Healthy Subjects aged 20-40
11080092|NCT01467960|FG001|Participant Flow|Group II|30 Healthy Subjects aged 40-65
11080093|NCT01467960|FG002|Participant Flow|Group III|30 Healthy Subjects aged more than 65
11080094|NCT01467960|FG003|Participant Flow|Group A|30 Patients at Stage I, H&Y classification
11080095|NCT01467960|FG004|Participant Flow|Group B|30 Patients at Stage II, H&Y classification
11080096|NCT01467960|FG005|Participant Flow|Group C|30 Patients at Stage more than III, H&Y classification
11080097|NCT01467960|OG000|Outcome|Group I|Healthy Subjects aged 20-40
11080098|NCT01467960|OG001|Outcome|Group II|Healthy Subjects aged 40-65
11080099|NCT01467960|OG002|Outcome|Group III|Healthy Subjects aged more than 65
11080100|NCT01467960|OG003|Outcome|Group A|Patients at Stage I, H&Y
11080101|NCT01467960|OG004|Outcome|Group B|Patients at Stage II, H&Y
11080102|NCT01467960|OG005|Outcome|Group C|Patients at stage > than II, H&Y
11080103|NCT01467960|EG000|Reported Event|Group I|Healthy Subjects aged 20-40
11080104|NCT01467960|EG001|Reported Event|Group II|Healthy Subjects aged 40-65
11080105|NCT01467960|EG002|Reported Event|Group III|Healthy Subjects aged more than 65
11080106|NCT01467960|EG003|Reported Event|Group A|Patients at Stage I, H&Y
11080107|NCT01467960|EG004|Reported Event|Group B|Patients at Stage II, H&Y
11080108|NCT01467960|EG005|Reported Event|Group C|Patients at stage > than II, H&Y
11080109|NCT01467999|BG000|Baseline|Guanfacine|"Guanfacine, 4mg given once daily~Guanfacine: Guanfacine, 4mg given once daily"
11080110|NCT01467999|FG000|Participant Flow|Guanfacine|"Guanfacine, 4mg given once daily~Guanfacine: Guanfacine, 4mg given once daily"
11080111|NCT01467999|OG000|Outcome|Guanfacine|"Guanfacine, 4mg given once daily~Guanfacine: Guanfacine, 4mg given once daily"
11080112|NCT01467999|EG000|Reported Event|Guanfacine|"Guanfacine, 4mg given once daily~Guanfacine: Guanfacine, 4mg given once daily"
11080113|NCT01468012|BG000|Baseline|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
11080114|NCT01468012|BG001|Baseline|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
11080115|NCT01468012|BG002|Baseline|Non-randomized|
11080116|NCT01468012|BG003|Baseline|Total|Total of all reporting groups
11080117|NCT01468012|FG000|Participant Flow|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
11080118|NCT01468012|FG001|Participant Flow|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
11080119|NCT01468012|FG002|Participant Flow|Non-randomized|
11080120|NCT01468012|OG000|Outcome|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
11080121|NCT01468012|OG001|Outcome|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
11080122|NCT01468012|OG002|Outcome|Non-randomized|
11080123|NCT01468012|OG002|Outcome|Non-randomized|Participants who dropped from the study prior to randomization
11080124|NCT01468012|EG000|Reported Event|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
11080125|NCT01468012|EG001|Reported Event|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
11080126|NCT01468012|EG002|Reported Event|Non-randomized|Participants who dropped from the study prior to randomization
11080127|NCT01468077|BG000|Baseline|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
11080128|NCT01468077|BG001|Baseline|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
11080129|NCT01468077|BG002|Baseline|Total|Total of all reporting groups
11080130|NCT01468077|FG000|Participant Flow|Tocilizumab, Normal Administration|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
11080131|NCT01468077|FG001|Participant Flow|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
11080132|NCT01468077|OG000|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
11080133|NCT01468077|OG001|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
11080134|NCT01468077|EG000|Reported Event|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
11080135|NCT01468077|EG001|Reported Event|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
11080136|NCT01468181|BG000|Baseline|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
11080137|NCT01468181|BG001|Baseline|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
11080138|NCT01468181|BG002|Baseline|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
11080139|NCT01468181|BG003|Baseline|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
11080140|NCT01468181|BG004|Baseline|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
11080141|NCT01468181|BG005|Baseline|Total|Total of all reporting groups
11080142|NCT01468181|FG000|Participant Flow|LY2189265 + Sulfonylureas (SU)|"LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
11080143|NCT01468181|FG001|Participant Flow|LY2189265 + Biguanides (BG)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
11080144|NCT01468181|FG002|Participant Flow|LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
11080145|NCT01468181|FG003|Participant Flow|LY2189265 + Thiazolidin Edione (TZD)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
11080146|NCT01468181|FG004|Participant Flow|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
11080147|NCT01468181|OG000|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
11080148|NCT01468181|OG001|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
11080149|NCT01468181|OG002|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
11080150|NCT01468181|OG003|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
11080151|NCT01468181|OG004|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
11080152|NCT01468181|EG000|Reported Event|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
11080153|NCT01468181|EG001|Reported Event|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
11080154|NCT01468181|EG002|Reported Event|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
11080155|NCT01468181|EG003|Reported Event|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
11080156|NCT01468181|EG004|Reported Event|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
11080157|NCT01468207|BG000|Baseline|Placebo|Placebo for 12 weeks.
11080158|NCT01468207|BG001|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
11080159|NCT01468207|BG002|Baseline|Total|Total of all reporting groups
11080160|NCT01468207|FG000|Participant Flow|Placebo|Placebo for 12 weeks.
11080161|NCT01468207|FG001|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
11080162|NCT01468207|FG002|Participant Flow|Placebo/Adalimumab Every Week (EW)|Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks).
11080163|NCT01468207|FG003|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080164|NCT01468207|FG004|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
11080165|NCT01468207|FG005|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080166|NCT01468207|OG000|Outcome|Placebo|Placebo for 12 weeks.
11080167|NCT01468207|OG001|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
11080168|NCT01468207|OG002|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
11080169|NCT01468207|OG003|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
11080170|NCT01468207|OG004|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
11080171|NCT01468207|OG005|Outcome|Adalimumab Every Week (ew) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
11080172|NCT01468207|OG000|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
11080173|NCT01468207|OG001|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
11080174|NCT01468207|OG000|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
11080175|NCT01468207|OG001|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
11080176|NCT01468207|EG000|Reported Event|Placebo (Period 1)|Placebo for 12 weeks
11080177|NCT01468207|EG001|Reported Event|Adalimumab EW (Period 1)|Adalimumab every week (ew) for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
11080178|NCT01468207|EG002|Reported Event|Placebo/Adalimumab EW (Period 2)|Participants randomized to receive placebo in Period 1 were re-randomized to receive adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg every week (ew) from Week 16 to Week 35 in Period 2 (up to 24 weeks).
11080179|NCT01468207|EG003|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080180|NCT01468207|EG004|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive adalimumab 40 mg every other week (eow) from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
11233738|NCT02430870|EG003|Reported Event|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11080181|NCT01468207|EG005|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080182|NCT01468233|BG000|Baseline|Placebo|Placebo for 12 weeks
11080183|NCT01468233|BG001|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
11080184|NCT01468233|BG002|Baseline|Total|Total of all reporting groups
11080185|NCT01468233|FG000|Participant Flow|Placebo|Placebo for 12 weeks
11080186|NCT01468233|FG001|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
11080187|NCT01468233|FG002|Participant Flow|Placebo/Placebo|Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080188|NCT01468233|FG003|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080189|NCT01468233|FG004|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
11080190|NCT01468233|FG005|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080191|NCT01468233|OG000|Outcome|Placebo|Placebo for 12 weeks
11080192|NCT01468233|OG001|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
11080193|NCT01468233|OG002|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
11080194|NCT01468233|OG003|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
11080195|NCT01468233|OG004|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
11080196|NCT01468233|OG005|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
11080197|NCT01468233|OG000|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
11080198|NCT01468233|OG001|Outcome|Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
11080199|NCT01468233|OG000|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
11080200|NCT01468233|OG001|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
11080201|NCT01468233|EG000|Reported Event|Placebo (Period 1)|Placebo for 12 weeks.
11080202|NCT01468233|EG001|Reported Event|Adalimumab EW (Period 1)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
11080203|NCT01468233|EG002|Reported Event|Placebo/Placebo (Period 2)|Participants randomized to receive placebo in Period 1 received placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080204|NCT01468233|EG003|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080205|NCT01468233|EG004|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
11080206|NCT01468233|EG005|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
11080207|NCT01468311|BG000|Baseline|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
11080208|NCT01468311|FG000|Participant Flow|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
11080209|NCT01468311|OG000|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
11080210|NCT01468311|EG000|Reported Event|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
11080211|NCT01468337|BG000|Baseline|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
11080212|NCT01468337|FG000|Participant Flow|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
11091910|NCT01536795|BG001|Baseline|WR279,396 With Gauze and Tape Dressing|"24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).~WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days"
11091911|NCT01536795|BG002|Baseline|Total|Total of all reporting groups
11091912|NCT01536795|FG000|Participant Flow|WR279,396 With Tegaderm Dressing|"24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing~WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing"
11080213|NCT01468337|OG000|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
11080214|NCT01468337|EG000|Reported Event|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
11080215|NCT01468350|BG000|Baseline|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart~Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
11080216|NCT01468350|BG001|Baseline|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart~Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
11080217|NCT01468350|BG002|Baseline|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg~Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
11080218|NCT01468350|BG003|Baseline|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo~Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
11080219|NCT01468350|BG004|Baseline|Total|Total of all reporting groups
11080220|NCT01468350|FG000|Participant Flow|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart~Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
11080221|NCT01468350|FG001|Participant Flow|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart~Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
11080222|NCT01468350|FG002|Participant Flow|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg~Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
11080223|NCT01468350|FG003|Participant Flow|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo~Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
11080224|NCT01468350|OG000|Outcome|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
11080225|NCT01468350|OG001|Outcome|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
11080226|NCT01468350|OG002|Outcome|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
11080227|NCT01468350|OG003|Outcome|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
11080228|NCT01468350|EG000|Reported Event|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
11080229|NCT01468350|EG001|Reported Event|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
11080230|NCT01468350|EG002|Reported Event|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
11080231|NCT01468350|EG003|Reported Event|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
11080232|NCT01468454|BG000|Baseline|(18F-DOPA) PET/CT Imaging vs Surgical Results|18 F-DOPA: 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA given 10-15 minutes prior image acquisition.
11080233|NCT01468454|FG000|Participant Flow|F-DOPA PET/CT Imaging vs Surgical Result|18 F-DOPA: 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA given 10-15 minutes prior image acquisition.
11080234|NCT01468454|OG000|Outcome|PET/CT Imaging vs Surgical Result|PET/CT imaging results in patients with surgical histologic confirmation.
11080235|NCT01468454|OG000|Outcome|(18F-DOPA) PET/CT Imaging|"Obtain safety and efficacy data on the use of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET imaging in children with HI for the clinical indication of localizing a focal lesion~18 F-DOPA: 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA"
11080236|NCT01468454|EG000|Reported Event|(18F-DOPA) PET/CT Imaging|"Obtain safety and efficacy data on the use of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET imaging in children with HI for the clinical indication of localizing a focal lesion~18 F-DOPA: 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA"
11080237|NCT01468532|BG000|Baseline|Treatment (Chemotherapy, Receptor Agonist)|"Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~pasireotide: Given IM~prednisone: Given PO"
11080238|NCT01468532|FG000|Participant Flow|Treatment (Chemotherapy, Receptor Agonist)|"Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~pasireotide: Given IM~prednisone: Given PO"
11080239|NCT01468532|OG000|Outcome|Treatment (Chemotherapy, Receptor Agonist)|"Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~pasireotide: Given IM~prednisone: Given PO"
11080240|NCT01468532|EG000|Reported Event|Treatment (Chemotherapy, Receptor Agonist)|"Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~pasireotide: Given IM~prednisone: Given PO"
11080241|NCT01468558|BG000|Baseline|Overall Study|All subjects that were enrolled in the study.
11080242|NCT01468558|FG000|Participant Flow|Overall Study|Subjects first received MAP0004 1.0mg via oral inhalation followed by 48 hours of PK sampling, they then received Ketoconazole (400mg once a day for 4 days) followed by MAP0004 1.0mg and another 48 hours of PK sampling. After a 7-11 day washout, subjects returned to the clinic to receive 1.0mg IV DHE and 48 hours of PK sampling.
11080243|NCT01468558|OG000|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
11080244|NCT01468558|OG001|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
11080245|NCT01468558|OG002|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
11080246|NCT01468558|EG000|Reported Event|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
11080247|NCT01468558|EG001|Reported Event|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
11080248|NCT01468558|EG002|Reported Event|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
11080249|NCT01468584|BG000|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
11080250|NCT01468584|FG000|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
11080251|NCT01468584|OG000|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
11080252|NCT01468584|EG000|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
11080253|NCT01468597|BG000|Baseline|One Group|Emergency surgery
11080254|NCT01468597|FG000|Participant Flow|One Group|Emergency surgery
11080255|NCT01468597|OG000|Outcome|One Group|Emergency surgery
11080256|NCT01468597|EG000|Reported Event|One Group|Emergency surgery
11080257|NCT01468675|BG000|Baseline|Intervention|Risk Assessment and Prevention Recommendations provided to subjects
11080258|NCT01468675|BG001|Baseline|Control|Usual Care
11080259|NCT01468675|BG002|Baseline|Total|Total of all reporting groups
11080260|NCT01468675|FG000|Participant Flow|Intervention|Risk Assessment and Prevention Recommendations
11080261|NCT01468675|FG001|Participant Flow|Control|Control - Usual Care
11080262|NCT01468675|OG000|Outcome|Intervention|"Validated, web-based risk assessment is being used to assess personalized risk and generate a risk report~risk assessment survey; decision support for providers for prevention based on risk"
11080263|NCT01468675|OG001|Outcome|Control|Usual care
11080264|NCT01468675|EG000|Reported Event|Intervention|Intervention subjects completed a risk factors/perceptions assessment and received a 1 page Health Risk Assessment (HRA) prior to a primary care visit. This coded data was sent to the EHR. After their primary care visit, subjects again reported risk perception.
11080265|NCT01468675|EG001|Reported Event|Control|Control subjects completed a risk factors/perceptions assessment and received a 1 page Health Risk Assessment (HRA) AFTER their primary care visit. Coded data was not sent to the EHR.
11080266|NCT01468701|BG000|Baseline|Dabigatran Etexilate - Baseline (Phase II)|"Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080267|NCT01468701|BG001|Baseline|Vitamin K Antagonist (VKA) - Baseline (Phase II)|"Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080268|NCT01468701|BG002|Baseline|Rivaroxaban - Baseline (Phase II)|"Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080269|NCT01468701|BG003|Baseline|Apixaban - Baseline (Phase II)|"Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080270|NCT01468701|BG004|Baseline|Acetylsalicylic Acid (ASA) - Baseline (Phase II)|"Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080271|NCT01468701|BG005|Baseline|Antiplts Other Than ASA - Baseline (Phase II)|"Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080272|NCT01468701|BG006|Baseline|No Treatment - Baseline (Phase II)|"Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080273|NCT01468701|BG007|Baseline|Combinations With Oral Anticoagulants - Baseline (Phase II)|"Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase II were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080274|NCT01468701|BG008|Baseline|Dabigatran Etexilate - Baseline (Phase III)|"Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080275|NCT01468701|BG009|Baseline|Vitamin K Antagonist (VKA) - Baseline (Phase III)|"Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11091913|NCT01536795|FG001|Participant Flow|WR279,396 With Gauze and Tape Dressing|"24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).~WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days"
11080276|NCT01468701|BG010|Baseline|Rivaroxaban - Baseline (Phase III)|"Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080277|NCT01468701|BG011|Baseline|Apixaban - Baseline (Phase III)|"Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080278|NCT01468701|BG012|Baseline|Edoxaban - Baseline (Phase III)|"Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080279|NCT01468701|BG013|Baseline|Acetylsalicylic Acid (ASA) - Baseline (Phase III)|"Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080280|NCT01468701|BG014|Baseline|Antiplts Other Than ASA - Baseline (Phase III)|"Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080281|NCT01468701|BG015|Baseline|No Treatment - Baseline (Phase III)|"Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080282|NCT01468701|BG016|Baseline|Combinations With Oral Anticoagulants - Baseline (Phase III)|"Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080283|NCT01468701|BG017|Baseline|Total|Total of all reporting groups
11080284|NCT01468701|FG000|Participant Flow|Dabigatran Etexilate - Baseline (Phase II)|"Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080285|NCT01468701|FG001|Participant Flow|Vitamin K Antagonist (VKA) - Baseline (Phase II)|"Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080286|NCT01468701|FG002|Participant Flow|Rivaroxaban - Baseline (Phase II)|"Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080287|NCT01468701|FG003|Participant Flow|Apixaban - Baseline (Phase II)|"Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080288|NCT01468701|FG004|Participant Flow|Acetylsalicylic Acid (ASA) - Baseline (Phase II)|"Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080289|NCT01468701|FG005|Participant Flow|Antiplts Other Than ASA - Baseline (Phase II)|"Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080290|NCT01468701|FG006|Participant Flow|No Treatment - Baseline (Phase II)|"Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080291|NCT01468701|FG007|Participant Flow|Combinations With Oral Anticoagulants - Baseline (Phase II)|"Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080292|NCT01468701|FG008|Participant Flow|Dabigatran Etexilate - Baseline (Phase III)|"Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080293|NCT01468701|FG009|Participant Flow|Vitamin K Antagonist (VKA) - Baseline (Phase III)|"Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080294|NCT01468701|FG010|Participant Flow|Rivaroxaban - Baseline (Phase III)|"Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080295|NCT01468701|FG011|Participant Flow|Apixaban - Baseline (Phase III)|"Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080296|NCT01468701|FG012|Participant Flow|Edoxaban - Baseline (Phase III)|"Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080297|NCT01468701|FG013|Participant Flow|Acetylsalicylic Acid (ASA) - Baseline (Phase III)|"Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11091914|NCT01536795|OG000|Outcome|WR279,396 With Tegaderm Dressing|"24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing~WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing"
11080298|NCT01468701|FG014|Participant Flow|Antiplts Other Than ASA - Baseline (Phase III)|"Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080299|NCT01468701|FG015|Participant Flow|No Treatment - Baseline (Phase III)|"Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080300|NCT01468701|FG016|Participant Flow|Combinations With Oral Anticoagulants - Baseline (Phase III)|"Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080301|NCT01468701|OG000|Outcome|Dabigatran Etexilate - Baseline (Phase II)|"Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080302|NCT01468701|OG000|Outcome|Dabigatran Etexilate - Baseline (Phase III)|"Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080303|NCT01468701|OG001|Outcome|Vitamin K Antagonist (VKA) - Baseline (Phase III)|"Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080304|NCT01468701|EG000|Reported Event|Dabigatran Etexilate - Baseline (Phase II)|"Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.~Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician."
11080305|NCT01468701|EG001|Reported Event|Dabigatran Etexilate - at Least Once During Phase III of the Study|"All patients who received at least once dabigatran etexilate during phase III of the study were included in the group. Adverse events which happened when the patients received dabigatran etexilate were reported in this group.~Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11080306|NCT01468701|EG002|Reported Event|Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study|"All patients who received at least once Vitamin K Antagonist (VKA) during phase III of the study were included in the group. Adverse events which happened when the patients received Vitamin K Antagonist (VKA) were reported in this group.~Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11080307|NCT01468701|EG003|Reported Event|Rivaroxaban - at Least Once During Phase III of the Study|"All patients who received at least once Rivaroxaban during phase III of the study were included in the group. Adverse events which happened when the patients received Rivaroxaban were reported in this group.~Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11080308|NCT01468701|EG004|Reported Event|Apixaban - at Least Once During Phase III of the Study|"All patients who received at least once Apixaban during phase III of the study were included in the group. Adverse events which happened when the patients received Apixaban were reported in this group.~Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11150376|NCT01877408|FG001|Participant Flow|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
11080309|NCT01468701|EG005|Reported Event|Edoxaban - at Least Once During Phase III of the Study|"All patients who received at least once Edoxaban during phase III of the study were included in the group. Adverse events which happened when the patients received Edoxaban were reported in this group.~Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11080310|NCT01468701|EG006|Reported Event|Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study|"All patients who received at least once Acetylsalicylic acid (ASA) during phase III of the study were included in the group. Adverse events which happened when the patients received Acetylsalicylic acid (ASA) were reported in this group.~Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11080311|NCT01468701|EG007|Reported Event|Antiplts Other Than ASA - at Least Once During Phase III of the Study|"All patients who received at least once Antiplts other than ASA during phase III of the study were included in the group. Adverse events which happened when the patients received Antiplts other than ASA were reported in this group.~Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive."
11080312|NCT01468818|BG000|Baseline|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
11080313|NCT01468818|FG000|Participant Flow|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
11080314|NCT01468818|OG000|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
11080315|NCT01468818|EG000|Reported Event|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
11080316|NCT01468844|BG000|Baseline|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg pink opaque capsule"
11080317|NCT01468844|BG001|Baseline|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months~Placebo: Placebo"
11080318|NCT01468844|BG002|Baseline|Total|Total of all reporting groups
11080319|NCT01468844|FG000|Participant Flow|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg pink opaque capsule"
11080320|NCT01468844|FG001|Participant Flow|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months~Placebo: Placebo"
11080321|NCT01468844|OG000|Outcome|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.~Minocycline: 100 mg pink opaque capsule~Bevacizumab: 1.25 mg bevacizumab injection"
11080322|NCT01468844|OG001|Outcome|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.~Placebo: Placebo~Bevacizumab: 1.25 mg bevacizumab injection"
11080323|NCT01468844|OG000|Outcome|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg pink opaque capsule~Bevacizumab: 1.25 mg bevacizumab injection"
11080324|NCT01468844|OG001|Outcome|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months~Placebo: Placebo~Bevacizumab: 1.25 mg bevacizumab injection"
11080325|NCT01468844|OG001|Outcome|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg pink opaque capsule~Bevacizumab: 1.25 mg bevacizumab injection"
11080326|NCT01468844|EG000|Reported Event|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg pink opaque capsule"
11080327|NCT01468844|EG001|Reported Event|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months~Placebo: Placebo"
11080328|NCT01468909|BG000|Baseline|Paclitaxel + Placebo|Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
11080329|NCT01468909|BG001|Baseline|Paclitaxel + Pazopanib|Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
11080330|NCT01468909|BG002|Baseline|Total|Total of all reporting groups
11080331|NCT01468909|FG000|Participant Flow|Paclitaxel + Placebo|Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
11080332|NCT01468909|FG001|Participant Flow|Paclitaxel + Pazopanib|Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
11080333|NCT01468909|OG000|Outcome|Paclitaxel + Placebo|Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
11080334|NCT01468909|OG001|Outcome|Paclitaxel + Pazopanib|Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
11080335|NCT01468909|EG000|Reported Event|Paclitaxel + Placebo|Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
11080336|NCT01468909|EG001|Reported Event|Paclitaxel + Pazopanib|Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
11091915|NCT01536795|OG001|Outcome|WR279,396 With Gauze and Tape Dressing|"24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).~WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days"
11091916|NCT01536795|EG000|Reported Event|WR279,396 With Tegaderm Dressing|"24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing~WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing"
11091917|NCT01536795|EG001|Reported Event|WR279,396 With Gauze and Tape Dressing|"24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).~WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days"
11091918|NCT01536860|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first.
11091919|NCT01536860|FG000|Participant Flow|Control Test Drink/Exp Test Drink 1/Exp Test Drink 2|"Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 1 followed by a 3 day wash out period. Consume Exp Test Drink 2 over a 15 minute period"
11091920|NCT01536860|FG001|Participant Flow|Exp Test Drink 1/Control Test Drink/Exp Test Drink 2|"Consume Exp Test Drink 1 once over a 15 minute period followed by a 3 day wash out period.~Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 2 once over a 15 minute period."
11227540|NCT02383758|FG000|Participant Flow|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
11091921|NCT01536860|FG002|Participant Flow|Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1|"Consume Exp Test Drink 2 once over a 15 minute period followed by a 3 day wash out period.~Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 1 once over a 15 minute period."
11091922|NCT01536860|OG000|Outcome|Control Test Drink|"Control Drink~Dietary Intervention : 300 ml of liquid food product"
11091923|NCT01536860|OG001|Outcome|Experimental Test Drink 1|"Control Drink containing ingredient 1~Dietary Intervention : 300 ml of liquid food product"
11091924|NCT01536860|OG002|Outcome|Experimental Test Drink 2|"Control Drink containing ingredient 2~Dietary Intervention : 300 ml of liquid food product"
11091925|NCT01536860|EG000|Reported Event|Control Test Drink|"Control Drink~Dietary Intervention : 300 ml of liquid food product"
11091926|NCT01536860|EG001|Reported Event|Experimental Test Drink 1|"Control Drink containing ingredient 1~Dietary Intervention : 300 ml of liquid food product"
11091927|NCT01536860|EG002|Reported Event|Experimental Test Drink 2|"Control Drink containing ingredient 2~Dietary Intervention : 300 ml of liquid food product"
11091928|NCT01536886|BG000|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
11091929|NCT01536886|BG001|Baseline|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
11091930|NCT01536886|BG002|Baseline|LEO 90100 Vehicle|Aerosol foam with no active ingredients
11091931|NCT01536886|BG003|Baseline|Ointment Vehicle|Ointment with no active ingredients
11091932|NCT01536886|BG004|Baseline|Total|Total of all reporting groups
11091933|NCT01536886|FG000|Participant Flow|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
11091934|NCT01536886|FG001|Participant Flow|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
11091935|NCT01536886|FG002|Participant Flow|LEO 90100 Vehicle|Aerosol foam with no active ingredients
11091936|NCT01536886|FG003|Participant Flow|Ointment Vehicle|Ointment with no active ingredients
11091937|NCT01536886|OG000|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
11091938|NCT01536886|OG001|Outcome|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
11091939|NCT01536886|OG002|Outcome|LEO 90100 Vehicle|Aerosol foam with no active ingredients
11091940|NCT01536886|OG003|Outcome|Ointment Vehicle|Ointment with no active ingredients
11091941|NCT01536886|EG000|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
11080337|NCT01468974|BG000|Baseline|ESPRIT BVS|Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
11080338|NCT01468974|FG000|Participant Flow|ESPRIT BVS|Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
11080339|NCT01468974|OG000|Outcome|ESPRIT BVS|Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
11080340|NCT01468974|EG000|Reported Event|ESPRIT BVS|"Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.~ESPRIT BVS: Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries"
11080341|NCT01468987|BG000|Baseline|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
11080342|NCT01468987|BG001|Baseline|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
11080343|NCT01468987|BG002|Baseline|Total|Total of all reporting groups
11080344|NCT01468987|FG000|Participant Flow|LY2605541 + Insulin Lispro|"Includes participants that were randomized to receive LY2605541 plus Insulin Lispro.~Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks."
11080345|NCT01468987|FG001|Participant Flow|Insulin Glargine + Insulin Lispro|"Includes participants that were randomized to receive Insulin Glargine plus Insulin Lispro.~Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
11080346|NCT01468987|OG000|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
11080347|NCT01468987|OG001|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
11080348|NCT01468987|OG001|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine were administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
11080349|NCT01468987|OG000|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
11080350|NCT01468987|EG000|Reported Event|LY2605541 + Insulin Lispro|"Participant-specific doses of LY2605541 were administered SC once daily at bedtime for 26 weeks.~Participant-specific doses of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
11080351|NCT01468987|EG001|Reported Event|Insulin Glargine + Insulin Lispro|"Participant-specific doses of Insulin Glargine were administered SC once daily at bedtime for 26 weeks.~Participant-specific doses of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
11080352|NCT01469000|BG000|Baseline|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
11080353|NCT01469000|BG001|Baseline|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
11080354|NCT01469000|BG002|Baseline|Total|Total of all reporting groups
11080355|NCT01469000|FG000|Participant Flow|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
11080356|NCT01469000|FG001|Participant Flow|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
11080357|NCT01469000|OG000|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
11080358|NCT01469000|OG001|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
11080359|NCT01469000|EG000|Reported Event|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
11080360|NCT01469000|EG001|Reported Event|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
11080361|NCT01469013|BG000|Baseline|Part A: 1 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy were administered 1 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080362|NCT01469013|BG001|Baseline|Part A: 2 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy were administered 2 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11091942|NCT01536886|EG001|Reported Event|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
11091943|NCT01536886|EG002|Reported Event|LEO 90100 Vehicle|Aerosol foam with no active ingredients
11080363|NCT01469013|BG002|Baseline|Part A: 4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy were administered 4 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080364|NCT01469013|BG003|Baseline|Part A: 8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy were administered 8 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080365|NCT01469013|BG004|Baseline|Part A: Placebo|Participants on background methotrexate therapy were administered placebo orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080366|NCT01469013|BG005|Baseline|Total|Total of all reporting groups
11080367|NCT01469013|FG000|Participant Flow|Part A: 1 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
11080368|NCT01469013|FG001|Participant Flow|Part A: 2 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
11080369|NCT01469013|FG002|Participant Flow|Part A: 4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
11080370|NCT01469013|FG003|Participant Flow|Part A: 8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
11080371|NCT01469013|FG004|Participant Flow|Part A: Placebo|Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
11080372|NCT01469013|FG005|Participant Flow|Part:1 mg Baricitinib(LY3009104) / 4 mg Baricitinib(LY3009104)|Participants on background methotrexate therapy who were administered 1 x 1-mg LY3009104 capsule +1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg LY3009104 and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080373|NCT01469013|FG006|Participant Flow|Part B: 2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30|Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080374|NCT01469013|FG007|Participant Flow|Part B: 4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30|Participants on background methotrexate therapy who were administered 1 x 4-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080375|NCT01469013|FG008|Participant Flow|Part B: Placebo /4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080376|NCT01469013|FG009|Participant Flow|Part B: 1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30|Participants on background methotrexate therapy who were administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080377|NCT01469013|FG010|Participant Flow|Part B: 2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY300|Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080378|NCT01469013|FG011|Participant Flow|Part B: 8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30|Participants on background methotrexate therapy who were administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080379|NCT01469013|FG012|Participant Flow|Part B: Placebo / 8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080380|NCT01469013|OG000|Outcome|Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
11080381|NCT01469013|OG001|Outcome|Part A: Placebo|Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
11080382|NCT01469013|OG000|Outcome|Combined 4 mg Baricitinib (LY3009104) (Part B)|Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080383|NCT01469013|OG001|Outcome|Combined 8 mg Baricitinib (LY3009104) (Part B)|Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsule or placebo capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080384|NCT01469013|OG000|Outcome|1 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
11080385|NCT01469013|OG001|Outcome|2 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
11080386|NCT01469013|OG002|Outcome|4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
11080387|NCT01469013|OG003|Outcome|8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
11080388|NCT01469013|OG004|Outcome|Placebo|Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
11091944|NCT01536886|EG003|Reported Event|Ointment Vehicle|Ointment with no active ingredients
11080389|NCT01469013|OG000|Outcome|Combined 4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080390|NCT01469013|OG001|Outcome|Combined 8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080391|NCT01469013|OG003|Outcome|8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) 4 capsules orally once daily for 12 weeks.
11080392|NCT01469013|EG000|Reported Event|Placebo|Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
11080393|NCT01469013|EG001|Reported Event|1 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
11080394|NCT01469013|EG002|Reported Event|2 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
11080395|NCT01469013|EG003|Reported Event|4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
11080396|NCT01469013|EG004|Reported Event|8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
11080397|NCT01469013|EG005|Reported Event|Placebo / 4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080398|NCT01469013|EG006|Reported Event|1 mg Baricitinib (LY3009104) / 4mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080399|NCT01469013|EG007|Reported Event|2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080400|NCT01469013|EG008|Reported Event|4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 4 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
11080401|NCT01469013|EG009|Reported Event|Placebo /8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080402|NCT01469013|EG010|Reported Event|1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080403|NCT01469013|EG011|Reported Event|2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080404|NCT01469013|EG012|Reported Event|8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)|Participants on background methotrexate therapy who were administered 8 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
11080405|NCT01469039|BG000|Baseline|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
11080406|NCT01469039|BG001|Baseline|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
11080407|NCT01469039|BG002|Baseline|Placebo|Intramuscular injection, given monthly
11080408|NCT01469039|BG003|Baseline|Total|Total of all reporting groups
11080409|NCT01469039|FG000|Participant Flow|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
11080410|NCT01469039|FG001|Participant Flow|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
11080411|NCT01469039|FG002|Participant Flow|Placebo|Intramuscular injection, given monthly
11080412|NCT01469039|OG000|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
11080413|NCT01469039|OG001|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
11080414|NCT01469039|OG002|Outcome|Placebo|Intramuscular injection, given monthly
11080415|NCT01469039|EG000|Reported Event|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
11080416|NCT01469039|EG001|Reported Event|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
11080417|NCT01469039|EG002|Reported Event|Placebo|Intramuscular injection, given monthly
11080418|NCT01469052|BG000|Baseline|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080419|NCT01469052|BG001|Baseline|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080420|NCT01469052|BG002|Baseline|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080421|NCT01469052|BG003|Baseline|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080422|NCT01469052|BG004|Baseline|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
11080423|NCT01469052|BG005|Baseline|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
11080424|NCT01469052|BG006|Baseline|Total|Total of all reporting groups
11227541|NCT02383758|FG001|Participant Flow|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
11233739|NCT02430870|EG004|Reported Event|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11080425|NCT01469052|FG000|Participant Flow|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 milligram (mg) tablet orally once daily (QD) followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally twice daily (BID) in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080426|NCT01469052|FG001|Participant Flow|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080427|NCT01469052|FG002|Participant Flow|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080428|NCT01469052|FG003|Participant Flow|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080429|NCT01469052|FG004|Participant Flow|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
11080430|NCT01469052|FG005|Participant Flow|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
11080431|NCT01469052|OG000|Outcome|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
11080432|NCT01469052|OG000|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080433|NCT01469052|OG001|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11233740|NCT02430870|EG005|Reported Event|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11080434|NCT01469052|OG002|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080435|NCT01469052|OG003|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
11080436|NCT01469052|OG004|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
11080437|NCT01469052|OG005|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
11080438|NCT01469052|OG000|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
11080439|NCT01469052|OG001|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
11080440|NCT01469052|EG000|Reported Event|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
11080441|NCT01469065|BG000|Baseline|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
11080442|NCT01469065|BG001|Baseline|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
11080443|NCT01469065|BG002|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
11080444|NCT01469065|BG003|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
11080445|NCT01469065|BG004|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
11080446|NCT01469065|BG005|Baseline|Total|Total of all reporting groups
11080447|NCT01469065|FG000|Participant Flow|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
11080448|NCT01469065|FG001|Participant Flow|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
11080449|NCT01469065|FG002|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
11080450|NCT01469065|FG003|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
11080451|NCT01469065|FG004|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
11080452|NCT01469065|OG000|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
11080453|NCT01469065|OG001|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
11080454|NCT01469065|OG002|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
11080455|NCT01469065|OG003|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
11080456|NCT01469065|OG004|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
11080457|NCT01469065|OG000|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
11080458|NCT01469065|OG001|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
11080459|NCT01469065|OG002|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
11080460|NCT01469065|OG003|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
11080461|NCT01469065|EG000|Reported Event|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
11080462|NCT01469065|EG001|Reported Event|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
11080463|NCT01469065|EG002|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
11080464|NCT01469065|EG003|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
11080465|NCT01469065|EG004|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
11080466|NCT01469182|BG000|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
11080467|NCT01469182|BG001|Baseline|Placebo|Matching placebo tablet, sublingual, once daily.
11080468|NCT01469182|BG002|Baseline|Total|Total of all reporting groups
11080469|NCT01469182|FG000|Participant Flow|SCH 39641 12 Amb a 1-U|12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an allergy immunotherapy tablet (AIT), sublingual, once daily.
11080470|NCT01469182|FG001|Participant Flow|Placebo|Matching placebo tablet, sublingual, once daily.
11080471|NCT01469182|OG000|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
11080472|NCT01469182|OG001|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
11080473|NCT01469182|EG000|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
11080474|NCT01469182|EG001|Reported Event|Placebo|Matching placebo tablet, sublingual, once daily.
11080475|NCT01469221|BG000|Baseline|Apaziquone|"Apaziquone (4 mg in 40 mL)~Apaziquone: 6 weekly multi-instillation of Apaziquone 4 mg in 40 mL"
11080476|NCT01469221|BG001|Baseline|Placebo|"Matching placebo (40 mL)~Placebo: 6 weekly multi-instillation of matching placebo in 40mL"
11080477|NCT01469221|BG002|Baseline|Total|Total of all reporting groups
11080478|NCT01469221|FG000|Participant Flow|Apaziquone|6 weekly multi-instillation of Apaziquone 4 mg in 40 mL
11080479|NCT01469221|FG001|Participant Flow|Placebo|6 weekly multi-instillation of matching placebo in 40 mL
11080480|NCT01469221|FG002|Participant Flow|Open Label-Apaziquone|Single dose of Apaziquone 4 mg in 40 mL
11080481|NCT01469221|OG000|Outcome|Apaziquone|"Apaziquone (4 mg in 40 mL)~Apaziquone: 6 weekly multi-instillation of Apaziquone 4 mg in 40 mL"
11080482|NCT01469221|OG001|Outcome|Placebo|"Matching placebo (40 mL)~Placebo: 6 weekly multi-instillation of matching placebo in 40mL"
11080483|NCT01469221|EG000|Reported Event|Apaziquone|6 weekly multi-instillation of Apaziquone 4 mg in 40 mL
11080484|NCT01469221|EG001|Reported Event|Placebo|6 weekly multi-instillation of matching placebo in 40 mL
11080485|NCT01469221|EG002|Reported Event|Open Label-Apaziquone|Single dose of Apaziquone 4 mg in 40 mL
11080486|NCT01469234|BG000|Baseline|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
11080487|NCT01469234|BG001|Baseline|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
11080488|NCT01469234|BG002|Baseline|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
11080489|NCT01469234|BG003|Baseline|Total|Total of all reporting groups
11080490|NCT01469234|FG000|Participant Flow|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
11080491|NCT01469234|FG001|Participant Flow|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
11080492|NCT01469234|FG002|Participant Flow|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
11080493|NCT01469234|OG000|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
11080494|NCT01469234|OG001|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
11080495|NCT01469234|OG002|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
11080496|NCT01469234|EG000|Reported Event|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
11080497|NCT01469234|EG001|Reported Event|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
11080498|NCT01469234|EG002|Reported Event|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
11080499|NCT01469364|BG000|Baseline|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
11080500|NCT01469364|FG000|Participant Flow|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
11091945|NCT01536938|BG000|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
11080501|NCT01469364|OG000|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
11080502|NCT01469364|EG000|Reported Event|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
11080503|NCT01469377|BG000|Baseline|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080504|NCT01469377|BG001|Baseline|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080505|NCT01469377|BG002|Baseline|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080506|NCT01469377|BG003|Baseline|Total|Total of all reporting groups
11080507|NCT01469377|FG000|Participant Flow|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080508|NCT01469377|FG001|Participant Flow|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080509|NCT01469377|FG002|Participant Flow|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080510|NCT01469377|OG000|Outcome|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080511|NCT01469377|OG001|Outcome|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080512|NCT01469377|OG002|Outcome|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080513|NCT01469377|EG000|Reported Event|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080514|NCT01469377|EG001|Reported Event|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080515|NCT01469377|EG002|Reported Event|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
11080516|NCT01469546|BG000|Baseline|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
11080517|NCT01469546|FG000|Participant Flow|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
11080518|NCT01469546|OG000|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
11080519|NCT01469546|EG000|Reported Event|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
11080520|NCT01469585|BG000|Baseline|Active Comparator: Subantimicrobial Doxycycline|Active comparator: Subantimicrobial doxycycline
11080521|NCT01469585|BG001|Baseline|No Intervention: Continuous Oral Contraceptive Pill|No intervention: Continuous oral contraceptive pill
11080522|NCT01469585|BG002|Baseline|Total|Total of all reporting groups
11080523|NCT01469585|FG000|Participant Flow|Sub-antimicrobial Doxycycline|"Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.~Doxycycline: 40 mg orally at the start of cycle 3 (study day 57) for 28 days."
11080524|NCT01469585|FG001|Participant Flow|Continuous Oral Contraceptive Pill|Women will take only the continuous oral contraceptive.
11080525|NCT01469585|OG000|Outcome|Sub-antimicrobial Doxycycline Group|Sub-antimicrobial doxycycline group (controlled release subantimicrobial doxycycyline 40 mg once daily)
11080526|NCT01469585|OG001|Outcome|Control|Control (no medication)
11080527|NCT01469585|OG000|Outcome|Sub-antimicrobial Doxycycline|"Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.~Doxycycline: 40 mg orally at the start of cycle 3 (study day 57) for 28 days."
11080528|NCT01469585|OG001|Outcome|Continuous Oral Contraceptive Pill|Women will take only the continuous oral contraceptive.
11080529|NCT01469585|EG000|Reported Event|Sub-antimicrobial Doxycycline|"Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.~Doxycycline: 40 mg orally at the start of cycle 3 (study day 57) for 28 days."
11080530|NCT01469585|EG001|Reported Event|Continuous Oral Contraceptive Pill|Women will take only the continuous oral contraceptive.
11080531|NCT01469637|BG000|Baseline|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
11080532|NCT01469637|BG001|Baseline|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
11080533|NCT01469637|BG002|Baseline|Total|Total of all reporting groups
11080534|NCT01469637|FG000|Participant Flow|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
11080535|NCT01469637|FG001|Participant Flow|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
11080536|NCT01469637|OG000|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
11091946|NCT01536938|BG001|Baseline|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
11080537|NCT01469637|OG001|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
11080538|NCT01469637|EG000|Reported Event|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
11080539|NCT01469637|EG001|Reported Event|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
11080540|NCT01469715|BG000|Baseline|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
11080541|NCT01469715|FG000|Participant Flow|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
11080542|NCT01469715|OG000|Outcome|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
11080543|NCT01469715|EG000|Reported Event|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
11080544|NCT01469767|BG000|Baseline|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
11080545|NCT01469767|FG000|Participant Flow|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
11080546|NCT01469767|OG000|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
11080547|NCT01469767|EG000|Reported Event|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
11080548|NCT01469819|BG000|Baseline|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
11080549|NCT01469819|FG000|Participant Flow|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
11080550|NCT01469819|OG000|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
11080551|NCT01469819|OG000|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients aster all inclusionary criteria were met.
11080552|NCT01469819|OG000|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as ≥ 2 times increase in their weekly bowel movement.
11080553|NCT01469819|OG001|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement.
11080554|NCT01469819|OG000|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as > 2 times increase in their weekly bowel movement compared to baseline.
11080555|NCT01469819|OG001|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement
11080556|NCT01469819|OG000|Outcome|SIBO (+)|Twenty-five patients were tested for SIBO before treatment with lubiprostone and 17 (68.0%) were SIBO (+) at baseline.
11091947|NCT01536938|BG002|Baseline|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
11080557|NCT01469819|EG000|Reported Event|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
11080558|NCT01470001|BG000|Baseline|Solifenacin|"patients in this arm will receive drug~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
11080559|NCT01470001|BG001|Baseline|Placebo|"patients is this arm will receive placebo~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
11080560|NCT01470001|BG002|Baseline|Total|Total of all reporting groups
11080561|NCT01470001|FG000|Participant Flow|Treatment|study subjects who received solifenacin 5mg daily
11080562|NCT01470001|FG001|Participant Flow|Placebo|study subjects who received placebo daily
11080563|NCT01470001|OG000|Outcome|Solifenacin|"patients in this arm will receive drug~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
11080564|NCT01470001|OG001|Outcome|Placebo|"patients is this arm will receive placebo~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
11080565|NCT01470001|EG000|Reported Event|Solifenacin|"patients in this arm will receive drug~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
11080566|NCT01470001|EG001|Reported Event|Placebo|"patients is this arm will receive placebo~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
11080567|NCT01470027|BG000|Baseline|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080568|NCT01470027|BG001|Baseline|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080569|NCT01470027|BG002|Baseline|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
11080570|NCT01470027|BG003|Baseline|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080571|NCT01470027|BG004|Baseline|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080572|NCT01470027|BG005|Baseline|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
11080573|NCT01470027|BG006|Baseline|Total|Total of all reporting groups
11080574|NCT01470027|FG000|Participant Flow|N-acetylcysteine 1800mg|"N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080575|NCT01470027|FG001|Participant Flow|N-acetylcysteine 3600mg|"N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080576|NCT01470027|FG002|Participant Flow|Placebo|"Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
11080577|NCT01470027|OG000|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080578|NCT01470027|OG001|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080579|NCT01470027|OG002|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
11080580|NCT01470027|OG003|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080581|NCT01470027|OG004|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080582|NCT01470027|OG005|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
11080583|NCT01470027|EG000|Reported Event|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080584|NCT01470027|EG001|Reported Event|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080585|NCT01470027|EG002|Reported Event|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
11080586|NCT01470027|EG003|Reported Event|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080587|NCT01470027|EG004|Reported Event|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
11080588|NCT01470027|EG005|Reported Event|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
11080589|NCT01470118|BG000|Baseline|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
11080590|NCT01470118|BG001|Baseline|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
11080591|NCT01470118|BG002|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
11080592|NCT01470118|BG003|Baseline|Total|Total of all reporting groups
11080593|NCT01470118|FG000|Participant Flow|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
11080594|NCT01470118|FG001|Participant Flow|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
11080595|NCT01470118|FG002|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
11080596|NCT01470118|OG000|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
11080597|NCT01470118|OG001|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
11080598|NCT01470118|OG002|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
11080599|NCT01470118|EG000|Reported Event|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
11080600|NCT01470118|EG001|Reported Event|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
11080601|NCT01470118|EG002|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
11080602|NCT01470144|BG000|Baseline|Treatment|All patients who received at least one dose of EFI
11080603|NCT01470144|FG000|Participant Flow|Treatment|All patients who received at least one dose of EFI
11080604|NCT01470144|OG000|Outcome|Treatment|All patients who received at least one dose of EFI
11080605|NCT01470144|EG000|Reported Event|Treatment|All patients who received at least one dose of EFI
11080606|NCT01470170|BG000|Baseline|Group1|alfentanil 2.5ug/kg immediately before propofol
11080607|NCT01470170|BG001|Baseline|Group 2|alfentanil 2.5ug/kg two minutes before propofol
11080608|NCT01470170|BG002|Baseline|Group 3|alfentanil 5ug/kg immediately before propofol
11080609|NCT01470170|BG003|Baseline|Group 4|alfentanil 5ug/kg two minutes before propofol
11080610|NCT01470170|BG004|Baseline|Group 5/ Control|Propofol alone
11080611|NCT01470170|BG005|Baseline|Total|Total of all reporting groups
11080612|NCT01470170|FG000|Participant Flow|Group1|Alfentanil 2.5μg/kg immediately before TCI propofol administration
11080613|NCT01470170|FG001|Participant Flow|Group2|Alfentanil 5μg/kg immediately before TCI propofol administration
11080614|NCT01470170|FG002|Participant Flow|Group 3|Alfentanil 2.5μg/kg two minutes before TCI propofol administration
11080615|NCT01470170|FG003|Participant Flow|Group 4|Alfentanil 5μg/kg two minutes before TCI propofol administration
11080616|NCT01470170|FG004|Participant Flow|Group 5 Control|TCI propofol administration alone
11080617|NCT01470170|OG000|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
11080618|NCT01470170|OG001|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
11080619|NCT01470170|OG002|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
11080620|NCT01470170|OG003|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
11080621|NCT01470170|OG004|Outcome|Group 5 /Control|Propofol alone
11080622|NCT01470170|EG000|Reported Event|Group1|alfentanil 2.5ug/kg immediately before propofol
11080623|NCT01470170|EG001|Reported Event|Group 2|alfentanil 2.5ug/kg two minutes before propofol
11080624|NCT01470170|EG002|Reported Event|Group 3|alfentanil 5ug/kg immediately before propofol
11080625|NCT01470170|EG003|Reported Event|Group 4|alfentanil 5ug/kg two minutes before propofol
11080626|NCT01470170|EG004|Reported Event|Group 5 /Control|Propofol alone
11080627|NCT01470196|BG000|Baseline|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
11080628|NCT01470196|FG000|Participant Flow|Carfilzomib, Dexamethasone, and Rituximab|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
11080629|NCT01470196|OG000|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
11080630|NCT01470196|EG000|Reported Event|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
11080631|NCT01470248|BG000|Baseline|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
11080632|NCT01470248|FG000|Participant Flow|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
11091948|NCT01536938|BG003|Baseline|Total|Total of all reporting groups
11091949|NCT01536938|FG000|Participant Flow|LEO 90100|"LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)~Applied once daily for up to 4 weeks"
11080633|NCT01470248|OG000|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
11080634|NCT01470248|EG000|Reported Event|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
11080635|NCT01470417|BG000|Baseline|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
11080636|NCT01470417|BG001|Baseline|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
11080637|NCT01470417|BG002|Baseline|Total|Total of all reporting groups
11080638|NCT01470417|FG000|Participant Flow|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
11080639|NCT01470417|FG001|Participant Flow|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
11080640|NCT01470417|OG000|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
11080641|NCT01470417|OG001|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
11080642|NCT01470417|EG000|Reported Event|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
11080643|NCT01470417|EG001|Reported Event|Chemotherapy and ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
11080644|NCT01470469|BG000|Baseline|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
11227542|NCT02383758|OG000|Outcome|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
11080645|NCT01470469|BG001|Baseline|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
11080646|NCT01470469|BG002|Baseline|Total|Total of all reporting groups
11080647|NCT01470469|FG000|Participant Flow|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
11080648|NCT01470469|FG001|Participant Flow|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
11080649|NCT01470469|OG000|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
11080650|NCT01470469|OG001|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
11080651|NCT01470469|EG000|Reported Event|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
11080652|NCT01470469|EG001|Reported Event|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
11080653|NCT01470599|BG000|Baseline|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
11080654|NCT01470599|BG001|Baseline|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
11080655|NCT01470599|BG002|Baseline|Total|Total of all reporting groups
11080656|NCT01470599|FG000|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
11080657|NCT01470599|FG001|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
11080658|NCT01470599|OG000|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
11080659|NCT01470599|OG001|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
11080660|NCT01470599|EG000|Reported Event|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
11080661|NCT01470599|EG001|Reported Event|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
11080662|NCT01470612|BG000|Baseline|Tofacitinib 5 mg BID|Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
11080663|NCT01470612|BG001|Baseline|Tofacitinib 10 mg BID|Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
11080664|NCT01470612|BG002|Baseline|Total|Total of all reporting groups
11080665|NCT01470612|FG000|Participant Flow|Tofacitinib 5 mg BID|Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
11080666|NCT01470612|FG001|Participant Flow|Tofacitinib 10 mg BID|Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
11080667|NCT01470612|OG000|Outcome|Tofacitinib 5 mg BID|Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
11080668|NCT01470612|OG001|Outcome|Tofacitinib 10 mg BID|Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
11080669|NCT01470612|EG000|Reported Event|Tofacitinib 5 mg BID|Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
11080670|NCT01470612|EG001|Reported Event|Tofacitinib 10 mg BID|Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
11080671|NCT01470651|BG000|Baseline|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
11080672|NCT01470651|BG001|Baseline|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
11080673|NCT01470651|BG002|Baseline|Total|Total of all reporting groups
11080674|NCT01470651|FG000|Participant Flow|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
11080675|NCT01470651|FG001|Participant Flow|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
11080676|NCT01470651|OG000|Outcome|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
11080677|NCT01470651|OG001|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
11080678|NCT01470651|EG000|Reported Event|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
11080679|NCT01470651|EG001|Reported Event|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
11080680|NCT01470781|BG000|Baseline|Cognitive Remediation|"This arm will receive computer-based cognitive remediation treatment 3 times per week for 24 weeks, for a total of 70 hours of treatment~BrainWorks: 13 programs targeting cognition in 4 separate domains: Auditory processing, visual processing, social cognition, and executive functioning. Games are imbedded in a format that is engaging and interactive. Animated characters serve as directors for each program, explaining the tasks in both verbal and written formats and providing feedback on each trial and overall after each activity. Users move systematically through the programs and can track their progress as the go. Each session includes activities from several different games to maintain interest and train a variety of skills; however, games are presented in the order of domains listed above (i.e. auditory, then visual, then social, and finally executive) to avoid stimulus interference during the training."
11080681|NCT01470781|BG001|Baseline|Computer Control|"Group will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition~Computer Control: Sessions will involve generic computer games administered via the game interface Sporcle. Sporcle is a game site that offers a collection of quiz-type activities available on line. An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session."
11080682|NCT01470781|BG002|Baseline|Total|Total of all reporting groups
11080683|NCT01470781|FG000|Participant Flow|Cognitive Remediation|"This arm will receive computer-based cognitive remediation treatment 3 times per week for 24 weeks, for a total of 70 hours of treatment~BrainWorks: 13 programs targeting cognition in 4 separate domains: Auditory processing, visual processing, social cognition, and executive functioning. Games are imbedded in a format that is engaging and interactive. Animated characters serve as directors for each program, explaining the tasks in both verbal and written formats and providing feedback on each trial and overall after each activity. Users move systematically through the programs and can track their progress as the go. Each session includes activities from several different games to maintain interest and train a variety of skills; however, games are presented in the order of domains listed above (i.e. auditory, then visual, then social, and finally executive) to avoid stimulus interference during the training."
11080684|NCT01470781|FG001|Participant Flow|Computer Control|"Group will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition~Computer Control: Sessions will involve generic computer games administered via the game interface Sporcle. Sporcle is a game site that offers a collection of quiz-type activities available on line. An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session."
11080685|NCT01470781|OG000|Outcome|Cognitive Remediation|"This arm will receive computer-based cognitive remediation treatment 3 times per week for 24 weeks, for a total of 70 hours of treatment~BrainWorks: 13 programs targeting cognition in 4 separate domains: Auditory processing, visual processing, social cognition, and executive functioning. Games are imbedded in a format that is engaging and interactive. Animated characters serve as directors for each program, explaining the tasks in both verbal and written formats and providing feedback on each trial and overall after each activity. Users move systematically through the programs and can track their progress as the go. Each session includes activities from several different games to maintain interest and train a variety of skills; however, games are presented in the order of domains listed above (i.e. auditory, then visual, then social, and finally executive) to avoid stimulus interference during the training."
11080686|NCT01470781|OG001|Outcome|Computer Control|"Group will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition~Computer Control: Sessions will involve generic computer games administered via the game interface Sporcle. Sporcle is a game site that offers a collection of quiz-type activities available on line. An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session."
11080687|NCT01470781|OG001|Outcome|Computer Control|"Group will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition~Computer Control: Sessions will involve generic computer games administered via the game interface Sporcle. Sporcle is a game site that offers a collection of quiz-type activities available on line. T An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session."
11080688|NCT01470781|EG000|Reported Event|Cognitive Remediation|"This arm will receive computer-based cognitive remediation treatment 3 times per week for 24 weeks, for a total of 70 hours of treatment~BrainWorks: 13 programs targeting cognition in 4 separate domains: Auditory processing, visual processing, social cognition, and executive functioning. Games are imbedded in a format that is engaging and interactive. Animated characters serve as directors for each program, explaining the tasks in both verbal and written formats and providing feedback on each trial and overall after each activity. Users move systematically through the programs and can track their progress as the go. Each session includes activities from several different games to maintain interest and train a variety of skills; however, games are presented in the order of domains listed above (i.e. auditory, then visual, then social, and finally executive) to avoid stimulus interference during the training."
11080689|NCT01470781|EG001|Reported Event|Computer Control|"Group will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition~Computer Control: Sessions will involve generic computer games administered via the game interface Sporcle. Sporcle is a game site that offers a collection of quiz-type activities available on line. An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session."
11080690|NCT01470859|BG000|Baseline|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
11080691|NCT01470859|BG001|Baseline|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
11080692|NCT01470859|BG002|Baseline|Total|Total of all reporting groups
11080693|NCT01470859|FG000|Participant Flow|Levodopa|"Sinemet Controlled Release (CR)~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
11080694|NCT01470859|FG001|Participant Flow|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
11080695|NCT01470859|OG000|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
11080696|NCT01470859|OG001|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
11080697|NCT01470859|EG000|Reported Event|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
11080698|NCT01470859|EG001|Reported Event|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
11080699|NCT01470989|BG000|Baseline|Canakinumab 150 mg|Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
11080700|NCT01470989|BG001|Baseline|Triamcinolone Acetonide 40 mg|Participants received 40 mg Triamcinolone Acetonide intramuscular (IM) at randomization and upon new flare and re-treated with at least 1 dose of canakinumab.
11080701|NCT01470989|BG002|Baseline|Total|Total of all reporting groups
11080702|NCT01470989|FG000|Participant Flow|Canakinumab 150 mg|Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
11080703|NCT01470989|FG001|Participant Flow|Triamcinolone Acetonide 40 mg|Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
11080704|NCT01470989|OG000|Outcome|Canakinumab 150 mg|Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
11080705|NCT01470989|OG001|Outcome|Triamcinolone Acetonide 40 mg|Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
11080706|NCT01470989|OG000|Outcome|Canakinumab Retreatment|Participants received 150 mg canakinumab subcutaneously (S.C) at randomization and upon new flare and re-treated with at least 1 dose of canakinumab.
11080707|NCT01470989|OG001|Outcome|Triamcinolone Acetonide- Randomized to Canakinumab Treatment|Participants received 40 mg Triamcinolone Acetonide intramuscular (IM) at randomization and upon new flare and re-treated with at least 1 dose of canakinumab.
11080708|NCT01470989|EG000|Reported Event|Canakinumab 150 mg|Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
11080709|NCT01470989|EG001|Reported Event|Triamcinolone Acetonide 40 mg|Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
11080710|NCT01471015|BG000|Baseline|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
11080711|NCT01471015|BG001|Baseline|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
11080712|NCT01471015|BG002|Baseline|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
11080713|NCT01471015|BG003|Baseline|Total|Total of all reporting groups
11091950|NCT01536938|FG001|Participant Flow|Betamethasone Dipropionate|"Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)~Applied once daily for up to 4 weeks"
11080714|NCT01471015|FG000|Participant Flow|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
11080715|NCT01471015|FG001|Participant Flow|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
11080716|NCT01471015|FG002|Participant Flow|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
11080717|NCT01471015|OG000|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
11080718|NCT01471015|OG001|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
11080719|NCT01471015|OG002|Outcome|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
11080720|NCT01471015|EG000|Reported Event|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
11080721|NCT01471015|EG001|Reported Event|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
11080722|NCT01471015|EG002|Reported Event|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
11080723|NCT01471028|BG000|Baseline|ELAD Treatment|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 5 days followed by Standard of Care treatment through Study Day 91.
11233741|NCT02430870|EG006|Reported Event|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11080724|NCT01471028|BG001|Baseline|Standard of Care (Control)|Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
11080725|NCT01471028|BG002|Baseline|Total|Total of all reporting groups
11080726|NCT01471028|FG000|Participant Flow|ELAD Treatment|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care (SOC) treatment for a period of up to 5 days followed by Standard of Care treatment through STudy Day 91.
11080727|NCT01471028|FG001|Participant Flow|Standard of Care (Control)|Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
11080728|NCT01471028|OG000|Outcome|ELAD Treatment|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care (SOC) treatment for a period of up to 5 days followed by Standard of Care treatment through STudy Day 91.
11080729|NCT01471028|OG001|Outcome|Standard of Care (Control)|Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
11080730|NCT01471028|OG000|Outcome|ELAD Treatment|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 5 days followed by Standard of Care treatment through Study Day 91.
11080731|NCT01471028|OG000|Outcome|ELAD Treatment|"This group will receive treatment with ELAD plus standard of care treatment.~ELAD treatment: ELAD treatment consists of treatment with an extracorporeal liver assist system."
11080732|NCT01471028|OG001|Outcome|Standard of Care (Control)|"This group will receive standard of care treatment as defined in the protocol.~Standard of care (Control): Control receives standard medical treatment."
11080733|NCT01471028|EG000|Reported Event|ELAD Treatment|Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 5 days followed by Standard of Care treatment through Study Day 91.
11080734|NCT01471028|EG001|Reported Event|Standard of Care (Control)|Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
11080735|NCT01471041|BG000|Baseline|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
11080736|NCT01471041|FG000|Participant Flow|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
11080737|NCT01471041|OG000|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
11080738|NCT01471041|EG000|Reported Event|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
11091951|NCT01536938|FG002|Participant Flow|Calcipotriol Aerosol Foam|"Calcipotriol aerosol foam: calcipotriol 50 mcg/g.~Applied once daily for up to 4 weeks"
11080739|NCT01471054|BG000|Baseline|Ozurdex|"Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Afterwards, patients will be seen every 2 months. At each visit patients will undergo measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Each eye in the Ozurdex group can have a maximum total of three Ozurdex insertions at minimum of 4-month intervals in the first year of study.~The criteria for retreatment with Ozurdex are:~i.The study eye must have shown initial favorable response to prior Ozurdex implant (>10% decrease in central macular thickness with maintenance [change in BCVA of <=1 line] or improvement of visual acuity [increase of BCVA of >1 line]) ii. Interval since last Ozurdex implant should be > 4 and < 12 months. iii. The study eye must show definite evidence of recurrence of macular edema."
11080740|NCT01471054|BG001|Baseline|Bevacizumab|"Patients will be followed at 1 week after the initial bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Afterwards, the patients will be examined every 4-8 weeks. At each visit patients will be checked for side effects of treatment, measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Eyes in the Bevacizumab group can have a maximum total of twelve (12) bevacizumab injections at minimum of 4-week intervals in the first year after enrolling into the study.~All patients will receive 6 monthly injections after entering the study. After the sixth injection (at month 5) the interval between injections will be extended to 6 weeks if the study eye has shown initial favorable response to prior intravitreal bevacizumab."
11080741|NCT01471054|BG002|Baseline|Total|Total of all reporting groups
11080742|NCT01471054|FG000|Participant Flow|Ozurdex|"Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Afterwards, patients will be seen every 2 months. At each visit patients will undergo measurement of best-corrected visual acuity (BCVA), complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Each eye in the Ozurdex group can have a maximum total of three Ozurdex insertions at minimum of 4-month intervals in the first year of study.~The criteria for retreatment with Ozurdex are:~i.The study eye must have shown initial favorable response to prior Ozurdex implant (>10% decrease in central macular thickness with maintenance [change in BCVA of <=1 line] or improvement of visual acuity [increase of BCVA of >1 line]) ii. Interval since last Ozurdex implant should be > 4 and < 12 months. iii. The study eye must show definite evidence of recurrence of macular edema."
11080743|NCT01471054|FG001|Participant Flow|Bevacizumab|"Patients will be followed at 1 week after the initial bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Afterwards, the patients will be examined every 4-8 weeks. At each visit patients will be checked for side effects of treatment, measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Eyes in the Bevacizumab group can have a maximum total of twelve (12) bevacizumab injections at minimum of 4-week intervals in the first year after enrolling into the study.~All patients will receive 6 monthly injections after entering the study. After the sixth injection (at month 5) the interval between injections will be extended to 6 weeks if the study eye has shown initial favorable response to prior intravitreal bevacizumab."
11080744|NCT01471054|OG000|Outcome|Ozurdex|"Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Afterwards, patients will be seen every 2 months. At each visit patients will undergo measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Each eye in the Ozurdex group can have a maximum total of three Ozurdex insertions at minimum of 4-month intervals in the first year of study.~The criteria for retreatment with Ozurdex are:~i.The study eye must have shown initial favorable response to prior Ozurdex implant (>10% decrease in central macular thickness with maintenance [change in BCVA of <=1 line] or improvement of visual acuity [increase of BCVA of >1 line]) ii. Interval since last Ozurdex implant should be > 4 and < 12 months. iii. The study eye must show definite evidence of recurrence of macular edema."
11080745|NCT01471054|OG001|Outcome|Bevacizumab|"Patients will be followed at 1 week after the initial bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Afterwards, the patients will be examined every 4-8 weeks. At each visit patients will be checked for side effects of treatment, measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Eyes in the Bevacizumab group can have a maximum total of twelve (12) bevacizumab injections at minimum of 4-week intervals in the first year after enrolling into the study.~All patients will receive 6 monthly injections after entering the study. After the sixth injection (at month 5) the interval between injections will be extended to 6 weeks if the study eye has shown initial favorable response to prior intravitreal bevacizumab."
11080746|NCT01471054|OG000|Outcome|Ozurdex|Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for outcome of treatment, including change in central macular thickness.
11080747|NCT01471054|OG001|Outcome|Bevacizumab|Patients will be followed at 1 week after intravitreal bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for outcome of treatment, including change in central macular thickness.
11080748|NCT01471054|OG000|Outcome|Ozurdex|Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, including increased intraocular pressure.
11080749|NCT01471054|OG001|Outcome|Bevacizumab|Patients will be followed at 1 week after intravitreal bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, including increased intraocular pressure.
11080750|NCT01471054|OG000|Outcome|Ozurdex|Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, including cataract.
11091952|NCT01536938|OG000|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
11080751|NCT01471054|OG001|Outcome|Bevacizumab|Patients will be followed at 1 week after intravitreal bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, including cataract.
11080752|NCT01471054|OG000|Outcome|Ozurdex|Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, including retinal detachment.
11080753|NCT01471054|OG001|Outcome|Bevacizumab|Patients will be followed at 1 week after intravitreal bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, including retinal detachment.
11080754|NCT01471054|OG000|Outcome|Ozurdex|Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, including vitreous hemorrhage.
11080755|NCT01471054|OG001|Outcome|Bevacizumab|Patients will be followed at 1 week after intravitreal bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, including vitreous hemorrhage.
11080756|NCT01471054|EG000|Reported Event|Ozurdex|"Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Afterwards, patients will be seen every 2 months. At each visit patients will undergo measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Each eye in the Ozurdex group can have a maximum total of three Ozurdex insertions at minimum of 4-month intervals in the first year of study.~The criteria for retreatment with Ozurdex are:~i.The study eye must have shown initial favorable response to prior Ozurdex implant (>10% decrease in central macular thickness with maintenance [change in BCVA of <=1 line] or improvement of visual acuity [increase of BCVA of >1 line]) ii. Interval since last Ozurdex implant should be > 4 and < 12 months. iii. The study eye must show definite evidence of recurrence of macular edema."
11080757|NCT01471054|EG001|Reported Event|Bevacizumab|"Patients will be followed at 1 week after the initial bevacizumab injection and then at 1,2, 3,4, 5, and 6 months. Afterwards, the patients will be examined every 4-8 weeks. At each visit patients will be checked for side effects of treatment, measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Eyes in the Bevacizumab group can have a maximum total of twelve (12) bevacizumab injections at minimum of 4-week intervals in the first year after enrolling into the study.~All patients will receive 6 monthly injections after entering the study. After the sixth injection (at month 5) the interval between injections will be extended to 6 weeks if the study eye has shown initial favorable response to prior intravitreal bevacizumab."
11080758|NCT01471093|BG000|Baseline|OPC-12759 Solution|One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once.
11080759|NCT01471093|BG001|Baseline|OPC-12759 Suspension|One drop of OPC-12759 ophthalmic suspension was instilled into each eye once.
11080760|NCT01471093|BG002|Baseline|Total|Total of all reporting groups
11080761|NCT01471093|FG000|Participant Flow|OPC-12759 Solution With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed|"One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.~The second instillation was conducted within 14 days after the first instillation."
11080762|NCT01471093|FG001|Participant Flow|OPC-12759 Solution Without Nasal Root Pressed, Then OPC-12759 With Nasal Root Pressed|"One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.~The second instillation was conducted within 14 days after the first instillation."
11080763|NCT01471093|FG002|Participant Flow|OPC-12759 Suspension With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed|"One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.~The second instillation was conducted within 14 days after the first instillation."
11080764|NCT01471093|FG003|Participant Flow|OPC-12759 Suspension Without Nasal Root Pressed, Then OPC-12759 Solution With Nasal Root Pressed|"One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.~The second instillation was conducted within 14 days after the first instillation."
11080765|NCT01471093|OG000|Outcome|OPC-12759 Solution With Nasal Root Pressed/Not Pressed|"One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.~The second instillation was conducted within 14 days after the first instillation."
11080766|NCT01471093|OG001|Outcome|OPC-12759 Suspension With Nasal Root Pressed/Not Pressed|"One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.~The second instillation was conducted within 14 days after the first instillation."
11091953|NCT01536938|OG001|Outcome|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
11080767|NCT01471093|EG000|Reported Event|OPC-12759 Solution|One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation).
11080768|NCT01471093|EG001|Reported Event|OPC-12759 Suspension|One drop of OPC-12759 ophthalmic suspension was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation).
11080769|NCT01471171|BG000|Baseline|Overall Study Safety Population|All patients randomized into the crossover study were included in the safety population
11080770|NCT01471171|FG000|Participant Flow|Aclidinium Bromide 400 μg - Placebo|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
11080771|NCT01471171|FG001|Participant Flow|Placebo - Aclidinium Bromide 400 μg|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
11080772|NCT01471171|OG000|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
11080773|NCT01471171|OG001|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
11080774|NCT01471171|EG000|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
11080775|NCT01471171|EG001|Reported Event|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
11080776|NCT01471197|BG000|Baseline|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
11080777|NCT01471197|BG001|Baseline|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
11080778|NCT01471197|BG002|Baseline|Total|Total of all reporting groups
11080779|NCT01471197|FG000|Participant Flow|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
11080780|NCT01471197|FG001|Participant Flow|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 milligram per meter squared (mg/m^2), Once every 3 weeks during Treatment Phase, 10 minute infusion.
11080781|NCT01471197|OG000|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
11080782|NCT01471197|OG001|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
11080783|NCT01471197|EG000|Reported Event|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
11080784|NCT01471197|EG001|Reported Event|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
11080785|NCT01471353|BG000|Baseline|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
11080786|NCT01471353|FG000|Participant Flow|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
11080787|NCT01471353|OG000|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
11080788|NCT01471353|EG000|Reported Event|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
11080789|NCT01471379|BG000|Baseline|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
11080790|NCT01471379|BG001|Baseline|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
11080791|NCT01471379|BG002|Baseline|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
11080792|NCT01471379|BG003|Baseline|Total|Total of all reporting groups
11091954|NCT01536938|OG002|Outcome|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
11080793|NCT01471379|FG000|Participant Flow|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg twice a day (BID) (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran per orally (PO), BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
11080794|NCT01471379|FG001|Participant Flow|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
11080795|NCT01471379|FG002|Participant Flow|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
11080796|NCT01471379|OG000|Outcome|Group A (50mg - 100mg)|"Group A begins treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
11080797|NCT01471379|OG001|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
11080798|NCT01471379|OG002|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
11080799|NCT01471379|OG000|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
11080800|NCT01471379|EG000|Reported Event|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
11080801|NCT01471379|EG001|Reported Event|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
11080802|NCT01471379|EG002|Reported Event|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
11080803|NCT01471457|BG000|Baseline|Trimo-San Group|"Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly~Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly"
11080804|NCT01471457|BG001|Baseline|Control Group|Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
11080805|NCT01471457|BG002|Baseline|Total|Total of all reporting groups
11080806|NCT01471457|FG000|Participant Flow|Trimo-San Group|"Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly~Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly"
11080807|NCT01471457|FG001|Participant Flow|Control Group|Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
11080808|NCT01471457|OG000|Outcome|Trimo-San Group|"Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly~Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly"
11080809|NCT01471457|OG001|Outcome|Control Group|Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
11080810|NCT01471457|EG000|Reported Event|Trimo-San Group|"Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly~Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly"
11080811|NCT01471457|EG001|Reported Event|Control Group|Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
11080812|NCT01471522|BG000|Baseline|Invasive Strategy (INV)|Invasive Strategy (INV)
11080813|NCT01471522|BG001|Baseline|Conservative Strategy|Conservative Strategy
11080814|NCT01471522|BG002|Baseline|Total|Total of all reporting groups
11080815|NCT01471522|FG000|Participant Flow|Invasive Strategy (INV)|"Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.~Cardiac catheterization: Narrowed blood vessels can be opened without surgery using stents or bypassed with surgery. To determine the best approach, the doctor must assess the severity of blood vessel narrowings. This procedure is known as cardiac catheterization.~Coronary artery bypass graft surgery: Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, cabbage). The surgery creates new routes around narrowed and blocked heart arteries, allowing more blood flow to the heart.~Percutaneous coronary intervention: done as part of the cardiac catheterization procedure. A small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow."
11091955|NCT01536938|EG000|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
11080816|NCT01471522|FG001|Participant Flow|Conservative Strategy|"Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.~Lifestyle: diet, physical activity, smoking cessation~Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies"
11080817|NCT01471522|OG000|Outcome|Invasive Strategy (INV)|Invasive Strategy (INV)
11080818|NCT01471522|OG001|Outcome|Conservative Strategy|Conservative Strategy
11080819|NCT01471522|OG000|Outcome|Between Invasive and Conservative Strategy Arms|Invasive vs. Conservative
11080820|NCT01471522|EG000|Reported Event|Invasive Strategy (INV)|Invasive Strategy (INV)
11080821|NCT01471522|EG001|Reported Event|Conservative Strategy|Conservative Strategy
11080822|NCT01471574|BG000|Baseline|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080823|NCT01471574|BG001|Baseline|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080824|NCT01471574|BG002|Baseline|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11233742|NCT02430870|EG007|Reported Event|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
11080825|NCT01471574|BG003|Baseline|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080826|NCT01471574|BG004|Baseline|Total|Total of all reporting groups
11080827|NCT01471574|FG000|Participant Flow|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080828|NCT01471574|FG001|Participant Flow|HAART: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080829|NCT01471574|FG002|Participant Flow|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080830|NCT01471574|FG003|Participant Flow|Non--HAART Therapy|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080831|NCT01471574|OG000|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080832|NCT01471574|OG001|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11091956|NCT01536938|EG001|Reported Event|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
11080833|NCT01471574|OG002|Outcome|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received daclatasvir tablets, 90 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080834|NCT01471574|OG003|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080835|NCT01471574|OG004|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080836|NCT01471574|OG000|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080837|NCT01471574|OG001|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080838|NCT01471574|OG002|Outcome|HAART Therapy: Daclatasvir, 30mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg),, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080839|NCT01471574|OG002|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080840|NCT01471574|OG003|Outcome|HAART Therapy: Daclatasvir 30, 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080841|NCT01471574|EG000|Reported Event|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080842|NCT01471574|EG001|Reported Event|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080843|NCT01471574|EG002|Reported Event|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080844|NCT01471574|EG003|Reported Event|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
11080845|NCT01471626|BG000|Baseline|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
11080846|NCT01471626|FG000|Participant Flow|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
11080847|NCT01471626|OG000|Outcome|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
11080848|NCT01471626|EG000|Reported Event|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
11080849|NCT01471639|BG000|Baseline|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
11080850|NCT01471639|FG000|Participant Flow|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
11080851|NCT01471639|OG000|Outcome|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
11080852|NCT01471639|EG000|Reported Event|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
11080853|NCT01471691|BG000|Baseline|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
11080854|NCT01471691|BG001|Baseline|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
11080855|NCT01471691|BG002|Baseline|Total|Total of all reporting groups
11080856|NCT01471691|FG000|Participant Flow|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
11080857|NCT01471691|FG001|Participant Flow|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
11080858|NCT01471691|OG000|Outcome|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
11080859|NCT01471691|OG001|Outcome|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
11080860|NCT01471691|EG000|Reported Event|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
11080861|NCT01471691|EG001|Reported Event|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
11080862|NCT01471782|BG000|Baseline|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080863|NCT01471782|BG001|Baseline|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080864|NCT01471782|BG002|Baseline|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080865|NCT01471782|BG003|Baseline|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
11080866|NCT01471782|BG004|Baseline|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080867|NCT01471782|BG005|Baseline|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080868|NCT01471782|BG006|Baseline|Total|Total of all reporting groups
11080869|NCT01471782|FG000|Participant Flow|Phase 1: Blinatumomab 5 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080870|NCT01471782|FG001|Participant Flow|Phase 1: Blinatumomab 15 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080871|NCT01471782|FG002|Participant Flow|Phase 1: Blinatumomab 30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080872|NCT01471782|FG003|Participant Flow|Phase 1: Blinatumomab 15/30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
11091957|NCT01536938|EG002|Reported Event|Calcipotriol Aerosol Foam|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
11080873|NCT01471782|FG004|Participant Flow|Phase 1: Blinatumomab 5/15 µg/m²/Day|PK Expansion: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080874|NCT01471782|FG005|Participant Flow|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080875|NCT01471782|OG000|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080876|NCT01471782|OG001|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080877|NCT01471782|OG002|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080878|NCT01471782|OG003|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
11080879|NCT01471782|OG004|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080880|NCT01471782|OG005|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080881|NCT01471782|OG006|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080882|NCT01471782|OG002|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080883|NCT01471782|OG004|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080884|NCT01471782|OG000|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day.
11080885|NCT01471782|OG001|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
11080886|NCT01471782|OG002|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
11080887|NCT01471782|OG000|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080888|NCT01471782|OG001|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080889|NCT01471782|OG002|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11080890|NCT01471782|OG000|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080891|NCT01471782|OG000|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day..
11080892|NCT01471782|EG000|Reported Event|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080893|NCT01471782|EG001|Reported Event|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080894|NCT01471782|EG002|Reported Event|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
11150377|NCT01877408|OG000|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
11080895|NCT01471782|EG003|Reported Event|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
11080896|NCT01471782|EG004|Reported Event|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
11080897|NCT01471782|EG005|Reported Event|Total|All Participants who received blinatumomab administered as a continuous intravenous infusion at a constant daily flow rate.
11080898|NCT01472185|BG000|Baseline|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11080899|NCT01472185|BG001|Baseline|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11080900|NCT01472185|BG002|Baseline|Total|Total of all reporting groups
11080901|NCT01472185|FG000|Participant Flow|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11080902|NCT01472185|FG001|Participant Flow|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11080903|NCT01472185|OG000|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11080904|NCT01472185|OG001|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11080905|NCT01472185|EG000|Reported Event|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11080906|NCT01472185|EG001|Reported Event|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11080907|NCT01472289|BG000|Baseline|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
11080908|NCT01472289|FG000|Participant Flow|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells (BMMNCs) concentrate prepared using the Res-Q 60 technology (a point of care system) and injected the concentrate intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
11080909|NCT01472289|OG000|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
11080910|NCT01472289|EG000|Reported Event|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
11080911|NCT01472341|BG000|Baseline|All Participants|Participants receiving routine care under a diabetologist.
11080912|NCT01472341|FG000|Participant Flow|All Participants|Participants receiving routine care under a diabetologist.
11080913|NCT01472341|OG000|Outcome|All Participants|Participants receiving routine care under a diabetologist.
11080914|NCT01472341|EG000|Reported Event|All Participants|Participants receiving routine care under a diabetologist.
11080915|NCT01472380|BG000|Baseline|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
11080916|NCT01472380|FG000|Participant Flow|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
11080917|NCT01472380|OG000|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
11233743|NCT02431052|BG000|Baseline|Olumacostat Glasaretil Gel, Vehicle QD|Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
11080918|NCT01472380|OG001|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
11080919|NCT01472380|EG000|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
11080920|NCT01472380|EG001|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
11080921|NCT01472380|EG002|Reported Event|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
11080922|NCT01472432|BG000|Baseline|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
11080923|NCT01472432|BG001|Baseline|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
11080924|NCT01472432|BG002|Baseline|Total|Total of all reporting groups
11080925|NCT01472432|FG000|Participant Flow|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
11080926|NCT01472432|FG001|Participant Flow|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
11080927|NCT01472432|OG000|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
11080928|NCT01472432|OG001|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
11080929|NCT01472432|OG000|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~Placebo: Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea"
11080930|NCT01472432|OG001|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea"
11080931|NCT01472432|EG000|Reported Event|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
11080932|NCT01472432|EG001|Reported Event|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
11080933|NCT01472445|BG000|Baseline|Non-obese (Body Mass Index ≤ 25)|Non-obese participants receive Vitamin D at 400 or 10,000 IU/day
11080934|NCT01472445|BG001|Baseline|Obese (Body Mass Index > 25)|Obese participants receive Vitamin D at 400 or 10,000 IU/day
11080935|NCT01472445|BG002|Baseline|Total|Total of all reporting groups
11080936|NCT01472445|FG000|Participant Flow|Non-obese (Body Mass Index ≤ 25)|Non-obese participants receive Vitamin D at 400 or 10,000 IU/day
11080937|NCT01472445|FG001|Participant Flow|Obese (Body Mass Index > 25)|Obese participants receive Vitamin D at 400 or 10,000 IU/day
11080938|NCT01472445|OG000|Outcome|Non-obese (Body Mass Index ≤ 25)|Non-obese participants receive Vitamin D at 400 or 10,000 IU/day
11080939|NCT01472445|OG001|Outcome|Obese (Body Mass Index > 25)|Obese participants receive Vitamin D at 400 or 10,000 IU/day
11080940|NCT01472445|OG000|Outcome|Non-obese (Body Mass Index ≤ 25)|"Non-obese participants receiving Vitamin D at 400 IU/day.~Vitamin D"
11080941|NCT01472445|OG001|Outcome|Obese (Body Mass Index > 25)|"Obese participants receiving Vitamin D at 400 IU/day.~Vitamin D"
11080942|NCT01472445|EG000|Reported Event|Non-obese (Body Mass Index ≤ 25)|Non-obese participants receive Vitamin D at 400 or 10,000 IU/day
11080943|NCT01472445|EG001|Reported Event|Obese (Body Mass Index > 25)|Obese participants receive Vitamin D at 400 or 10,000 IU/day
11080944|NCT01472549|BG000|Baseline|Chlorhexidine-alcohol|"2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)~Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation"
11080945|NCT01472549|BG001|Baseline|Iodine-alcohol|"8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)~Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation."
11080946|NCT01472549|BG002|Baseline|Total|Total of all reporting groups
11080947|NCT01472549|FG000|Participant Flow|Chlorhexidine-alcohol|"2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)~Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation"
11080948|NCT01472549|FG001|Participant Flow|Iodine-alcohol|"8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)~Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation."
11080949|NCT01472549|OG000|Outcome|Chlorhexidine-alcohol|"2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)~Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation"
11080950|NCT01472549|OG001|Outcome|Iodine-alcohol|"8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)~Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation."
11080951|NCT01472549|EG000|Reported Event|Chlorhexidine-alcohol|"2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)~Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation"
11080952|NCT01472549|EG001|Reported Event|Iodine-alcohol|"8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)~Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation."
11080953|NCT01472718|BG000|Baseline|Standard Primary Coronary Intervention|standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
11080954|NCT01472718|BG001|Baseline|Coronary Thrombectomy|coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
11080955|NCT01472718|BG002|Baseline|Total|Total of all reporting groups
11080956|NCT01472718|FG000|Participant Flow|Standard Primary Coronary Intervention|standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
11080957|NCT01472718|FG001|Participant Flow|Coronary Thrombectomy|coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
11080958|NCT01472718|OG000|Outcome|Standard Primary Coronary Intervention|standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
11080959|NCT01472718|OG001|Outcome|Coronary Thrombectomy|coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
11080960|NCT01472718|EG000|Reported Event|Standard Primary Coronary Intervention|standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
11080961|NCT01472718|EG001|Reported Event|Coronary Thrombectomy|coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
11080962|NCT01472757|BG000|Baseline|Placebo|Placebo: Placebo delivered via a new dry powder inhaler
11080963|NCT01472757|BG001|Baseline|VR506 50 mcg|VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
11080964|NCT01472757|BG002|Baseline|VR506 100 mcg|VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
11080965|NCT01472757|BG003|Baseline|VR506 250 mcg|VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
11080966|NCT01472757|BG004|Baseline|Total|Total of all reporting groups
11080967|NCT01472757|FG000|Participant Flow|Placebo|Placebo: Placebo delivered via a new dry powder inhaler
11080968|NCT01472757|FG001|Participant Flow|VR506 50 mcg|VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
11080969|NCT01472757|FG002|Participant Flow|VR506 100 mcg|VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
11080970|NCT01472757|FG003|Participant Flow|VR506 250 mcg|VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
11080971|NCT01472757|OG000|Outcome|Placebo|Placebo: Placebo delivered via a new dry powder inhaler
11080972|NCT01472757|OG001|Outcome|VR506 50 mcg|VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
11080973|NCT01472757|OG002|Outcome|VR506 100 mcg|VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
11080974|NCT01472757|OG003|Outcome|VR506 250 mcg|VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
11080975|NCT01472757|EG000|Reported Event|Placebo|Placebo: Placebo delivered via a new dry powder inhaler
11080976|NCT01472757|EG001|Reported Event|VR506 50 mcg|VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
11080977|NCT01472757|EG002|Reported Event|VR506 100 mcg|VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
11080978|NCT01472757|EG003|Reported Event|VR506 250 mcg|VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
11080979|NCT01472822|BG000|Baseline|Omija|
11080980|NCT01472822|BG001|Baseline|Placebo|
11080981|NCT01472822|BG002|Baseline|Total|Total of all reporting groups
11080982|NCT01472822|FG000|Participant Flow|Omija Extract.|"Omija extract.(2times/day, 4tablets/day, 1.2g/day) for 12weeks~Omija extract.: Omija extracted with ethanol and then concentrated and dried."
11080983|NCT01472822|FG001|Participant Flow|Placebo|"Placebo(2times/day, 4tablets/day, 1.2g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Omija extract.."
11080984|NCT01472822|OG000|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
11080985|NCT01472822|OG001|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
11080986|NCT01472822|EG000|Reported Event|Omija|
11080987|NCT01472822|EG001|Reported Event|Placebo|
11080988|NCT01472835|BG000|Baseline|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
11080989|NCT01472835|BG001|Baseline|Control|Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure
11080990|NCT01472835|BG002|Baseline|Total|Total of all reporting groups
11080991|NCT01472835|FG000|Participant Flow|Sedation|"Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
11080992|NCT01472835|FG001|Participant Flow|Control|Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure
11080993|NCT01472835|OG000|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
11080994|NCT01472835|OG001|Outcome|Control|Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
11080995|NCT01472835|OG000|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
11080996|NCT01472835|OG001|Outcome|Control|Patient will not receive sedation during procedure
11080997|NCT01472835|OG001|Outcome|Control|Patient will not receive sedation during the 1st procedure, but receive sedation during their 2nd procedure
11080998|NCT01472835|EG000|Reported Event|Sedation|"Pt received sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
11080999|NCT01472835|EG001|Reported Event|Control|Patient did not receive sedation during procedure
11081000|NCT01472874|BG000|Baseline|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
11081001|NCT01472874|FG000|Participant Flow|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
11081002|NCT01472874|OG000|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
11081003|NCT01472874|EG000|Reported Event|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
11081004|NCT01472939|BG000|Baseline|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
11081005|NCT01472939|BG001|Baseline|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
11081006|NCT01472939|BG002|Baseline|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
11081007|NCT01472939|BG003|Baseline|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
11081008|NCT01472939|BG004|Baseline|Total|Total of all reporting groups
11081009|NCT01472939|FG000|Participant Flow|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
11081010|NCT01472939|FG001|Participant Flow|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
11081011|NCT01472939|FG002|Participant Flow|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
11081012|NCT01472939|FG003|Participant Flow|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
11081013|NCT01472939|OG000|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
11081014|NCT01472939|OG001|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
11081015|NCT01472939|OG002|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
11081016|NCT01472939|OG003|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
11081017|NCT01472939|OG000|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
11081018|NCT01472939|OG001|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
11081019|NCT01472939|OG002|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
11081020|NCT01472939|EG000|Reported Event|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
11081021|NCT01472939|EG001|Reported Event|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
11081022|NCT01472939|EG002|Reported Event|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
11081023|NCT01472939|EG003|Reported Event|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
11227543|NCT02383758|OG001|Outcome|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
11081024|NCT01472965|BG000|Baseline|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
11081025|NCT01472965|BG001|Baseline|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
11081026|NCT01472965|BG002|Baseline|Total|Total of all reporting groups
11081027|NCT01472965|FG000|Participant Flow|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
11081028|NCT01472965|FG001|Participant Flow|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
11081029|NCT01472965|OG000|Outcome|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
11081030|NCT01472965|OG001|Outcome|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
11081031|NCT01472965|EG000|Reported Event|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
11081032|NCT01472965|EG001|Reported Event|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
11081033|NCT01473160|BG000|Baseline|Overall Study|All enrolled participants
11081034|NCT01473160|FG000|Participant Flow|Overall Study|All enrolled participants
11081035|NCT01473160|OG000|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
11081036|NCT01473160|OG001|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
11081037|NCT01473160|EG000|Reported Event|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
11081038|NCT01473160|EG001|Reported Event|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
11081039|NCT01473355|BG000|Baseline|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
11081040|NCT01473355|FG000|Participant Flow|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implant (diameter 3 mm) in lengths of 11-15 mm
11081041|NCT01473355|OG000|Outcome|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
11081042|NCT01473355|EG000|Reported Event|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
11081043|NCT01473368|BG000|Baseline|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
11081044|NCT01473368|BG001|Baseline|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
11081045|NCT01473368|BG002|Baseline|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
11081046|NCT01473368|BG003|Baseline|Control|control group
11081047|NCT01473368|BG004|Baseline|Total|Total of all reporting groups
11081048|NCT01473368|FG000|Participant Flow|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
11081049|NCT01473368|FG001|Participant Flow|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
11081050|NCT01473368|FG002|Participant Flow|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
11081051|NCT01473368|FG003|Participant Flow|Control|Control group
11081052|NCT01473368|OG000|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
11081053|NCT01473368|OG001|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
11081054|NCT01473368|OG002|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
11081055|NCT01473368|OG003|Outcome|Control|Control group
11081056|NCT01473368|OG000|Outcome|Prebiotic (Saccharomyces Boulardii) Before Treatment|"Before treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
11081057|NCT01473368|OG001|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
11081058|NCT01473368|OG002|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
11081059|NCT01473368|OG000|Outcome|Antibiotic (Amoxicillin Clavulanate) Before Treatment|"Before treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
11081060|NCT01473368|OG001|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
11081061|NCT01473368|OG002|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
11233744|NCT02431052|BG001|Baseline|Olumacostat Glasaretil Gel, Vehicle BID|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11233745|NCT02431052|BG002|Baseline|Olumacostat Glasaretil Gel, 4.0% QD|Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
11081062|NCT01473368|OG000|Outcome|Combination (Prebiotic and Antibiotic) Before Treatment|"Before treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
11081063|NCT01473368|OG001|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
11081064|NCT01473368|OG002|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
11081065|NCT01473368|OG000|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During Treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
11081066|NCT01473368|OG001|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After Treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
11081067|NCT01473368|OG002|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During Treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
11081068|NCT01473368|OG003|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After Treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
11081069|NCT01473368|OG004|Outcome|Core Microbiome|Core Microbiome
11081070|NCT01473368|OG005|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During Treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
11081071|NCT01473368|OG006|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After Treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
11081072|NCT01473368|EG000|Reported Event|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
11081073|NCT01473368|EG001|Reported Event|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
11081074|NCT01473368|EG002|Reported Event|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
11081075|NCT01473368|EG003|Reported Event|Control|
11081076|NCT01473381|BG000|Baseline|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
11081077|NCT01473381|BG001|Baseline|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
11091958|NCT01536951|BG000|Baseline|Part A (LY3009104 or Placebo)|Participants were randomized to 1 of 3 treatment sequences during Part A of the study and received a single dose (LY3009104 or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as either 20-milligrams (mg), 30-mg or 40-mg dose.
11081078|NCT01473381|BG002|Baseline|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
11081079|NCT01473381|BG003|Baseline|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
11081080|NCT01473381|BG004|Baseline|Total|Total of all reporting groups
11081081|NCT01473381|FG000|Participant Flow|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
11081082|NCT01473381|FG001|Participant Flow|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
11081083|NCT01473381|FG002|Participant Flow|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
11081084|NCT01473381|FG003|Participant Flow|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
11081085|NCT01473381|OG000|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
11227544|NCT02383758|EG000|Reported Event|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
11233746|NCT02431052|BG003|Baseline|Olumacostat Glasaretil Gel, 7.5% QD|Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
11233747|NCT02431052|BG004|Baseline|Olumacostat Glasaretil Gel, 7.5% BID|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
11233748|NCT02431052|BG005|Baseline|Total|Total of all reporting groups
11233749|NCT02431052|FG000|Participant Flow|Olumacostat Glasaretil Gel, Vehicle QD|Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
11081086|NCT01473381|OG001|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
11081087|NCT01473381|OG002|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
11081088|NCT01473381|OG003|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
11081089|NCT01473381|OG002|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days
11081090|NCT01473381|EG000|Reported Event|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
11081091|NCT01473381|EG001|Reported Event|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
11081092|NCT01473381|EG002|Reported Event|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
11081093|NCT01473381|EG003|Reported Event|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
11081094|NCT01473394|BG000|Baseline|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
11081095|NCT01473394|BG001|Baseline|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
11081096|NCT01473394|BG002|Baseline|Total|Total of all reporting groups
11081097|NCT01473394|FG000|Participant Flow|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
11081098|NCT01473394|FG001|Participant Flow|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
11081099|NCT01473394|OG000|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
11081100|NCT01473394|OG001|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
11081101|NCT01473394|EG000|Reported Event|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
11081102|NCT01473394|EG001|Reported Event|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
11081103|NCT01473407|BG000|Baseline|Epoetin Hospira|Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.
11081104|NCT01473407|BG001|Baseline|Epogen|Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
11081105|NCT01473407|BG002|Baseline|Total|Total of all reporting groups
11081106|NCT01473407|FG000|Participant Flow|Epoetin Hospira|Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.
11081107|NCT01473407|FG001|Participant Flow|Epogen|Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
11081108|NCT01473407|OG000|Outcome|Epoetin Hospira|Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.
11081109|NCT01473407|OG001|Outcome|Epogen|Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
11081110|NCT01473407|EG000|Reported Event|Epoetin Hospira|Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.
11081111|NCT01473407|EG001|Reported Event|Epogen|Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
11081112|NCT01473420|BG000|Baseline|Epoetin Hospira|During titration period participants who were on Epogen intravenous (IV) regimen prior to this study, were titrated and optimally stabilized to receive subcutaneous (SC) injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epoetin Hospira at optimal dose demonstrated in titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081113|NCT01473420|BG001|Baseline|Epogen|During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081114|NCT01473420|BG002|Baseline|Total|Total of all reporting groups
11091959|NCT01536951|BG001|Baseline|Part B (LY3009104, Moxifloxacin, or Placebo)|Participants were randomized to 1 of 6 treatment sequences during Part B of the study and received a single dose (LY3009104, moxifloxacin, or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as a 40-mg dose. Moxifloxacin was administered as a 400-mg tablet.
11233750|NCT02431052|FG001|Participant Flow|Olumacostat Glasaretil Gel, Vehicle BID|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11081115|NCT01473420|FG000|Participant Flow|Epoetin Hospira|During titration period participants who were on Epogen intravenous (IV) regimen prior to this study, were titrated and optimally stabilized to receive subcutaneous (SC) injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epoetin Hospira at optimal dose demonstrated in titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081116|NCT01473420|FG001|Participant Flow|Epogen|During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081117|NCT01473420|OG000|Outcome|Epoetin Hospira: Maintenance Period|During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081118|NCT01473420|OG001|Outcome|Epogen: Maintenance Period|During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081119|NCT01473420|OG000|Outcome|Epoetin Hospira: Titration Period|During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
11081120|NCT01473420|OG001|Outcome|Epogen: Titration Period|During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
11081121|NCT01473420|OG002|Outcome|Epoetin Hospira: Maintenance Period|During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081122|NCT01473420|OG003|Outcome|Epogen: Maintenance Period|During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081123|NCT01473420|EG000|Reported Event|Epoetin Hospira: Titration Period|During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
11081124|NCT01473420|EG001|Reported Event|Epogen: Titration Period|During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
11081125|NCT01473420|EG002|Reported Event|Epoetin Hospira: Maintenance Period|During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11081126|NCT01473420|EG003|Reported Event|Epogen: Maintenance Period|During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
11091960|NCT01536951|BG002|Baseline|Total|Total of all reporting groups
11233751|NCT02431052|FG002|Participant Flow|Olumacostat Glasaretil Gel, 4.0% QD|Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
11233752|NCT02431052|FG003|Participant Flow|Olumacostat Glasaretil Gel, 7.5% QD|Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
11233753|NCT02431052|FG004|Participant Flow|Olumacostat Glasaretil Gel, 7.5% BID|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
11081127|NCT01473524|BG000|Baseline|DB OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the DB phase.~After completion of the 12-month DB phase participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg."
11081128|NCT01473524|BG001|Baseline|DB OCA 10 mg|OCA 10 mg 12 months during the DB phase. After completion of the 12-month DB phase participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081129|NCT01473524|BG002|Baseline|DB Placebo|Matching placebo for 12 months during the DB phase. After completion of the 12-month DB phase participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081130|NCT01473524|BG003|Baseline|Total|Total of all reporting groups
11081131|NCT01473524|FG000|Participant Flow|DB OCA 5-10 mg|Obeticholic acid (OCA) 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the double-blind (DB) phase.
11081132|NCT01473524|FG001|Participant Flow|DB OCA 10 mg|OCA 10 mg for 12 months during DB phase.
11081133|NCT01473524|FG002|Participant Flow|DB Placebo|Matching placebo for 12 months in the DB phase.
11081134|NCT01473524|FG003|Participant Flow|LTSE OCA (DB OCA 5-10 mg)|Participants previously receiving OCA 5 to 10 mg in the DB phase received OCA in the open-label long-term safety extension (LTSE) phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081135|NCT01473524|FG004|Participant Flow|LTSE OCA (DB OCA 10 mg)|Participants previously receiving OCA 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081136|NCT01473524|FG005|Participant Flow|LTSE OCA (DB Placebo)|Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081137|NCT01473524|OG000|Outcome|DB OCA 10 mg|OCA 10 mg for 12 months during the DB phase.
11081138|NCT01473524|OG001|Outcome|DB Placebo|Matching placebo for 12 months during the DB phase.
11081139|NCT01473524|OG000|Outcome|LTSE OCA (DB OCA 5-10 mg)|Participants previously receiving OCA 5-10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081140|NCT01473524|OG001|Outcome|LTSE OCA (DB OCA 10 mg)|Participants previously receiving OCA 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081141|NCT01473524|OG002|Outcome|LTSE OCA (DB Placebo)|Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081142|NCT01473524|OG003|Outcome|Overall LTSE OCA|After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081143|NCT01473524|OG000|Outcome|Double-blind OCA 10 mg|OCA 10 mg for 12 months during the DB phase.
11081144|NCT01473524|OG001|Outcome|Double-blind Placebo|Matching placebo for 12 months during the DB phase.
11081145|NCT01473524|OG000|Outcome|DB OCA 5-10 mg|OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the DB phase.
11081146|NCT01473524|OG001|Outcome|DB OCA 10 mg|OCA 10 mg for 12 months during the DB phase.
11081147|NCT01473524|OG002|Outcome|DB Placebo|Matching placebo during the DB phase.
11081148|NCT01473524|OG002|Outcome|DB Placebo|Matching placebo for 12 months during the DB phase.
11081149|NCT01473524|OG000|Outcome|DB OCA 5-10 mg|OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 12 months of the DB phase.
11081150|NCT01473524|EG000|Reported Event|DB 5-10 mg|OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the DB phase.
11081151|NCT01473524|EG001|Reported Event|DB OCA 10 mg|OCA 10 mg for 12 months during the DB phase.
11081152|NCT01473524|EG002|Reported Event|DB Placebo|Matching placebo for 12 months during the DB phase.
11081153|NCT01473524|EG003|Reported Event|LTSE OCA (DB OCA 5-10 mg)|Participants previously receiving OCA 5 to 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081154|NCT01473524|EG004|Reported Event|LTSE OCA (DB 10 mg)|Participants previously receiving OCA 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081155|NCT01473524|EG005|Reported Event|LTSE OCA (DB Placebo)|Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11150378|NCT01877408|OG001|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
11081156|NCT01473524|EG006|Reported Event|Overall LTSE OCA|After completion of the 12-month DB phase, all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
11081157|NCT01473563|BG000|Baseline|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
11081158|NCT01473563|FG000|Participant Flow|Pemetrexed|Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (IV) infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
11081159|NCT01473563|OG000|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
11081160|NCT01473563|EG000|Reported Event|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
11081161|NCT01473589|BG000|Baseline|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081162|NCT01473589|BG001|Baseline|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081163|NCT01473589|BG002|Baseline|Total|Total of all reporting groups
11081164|NCT01473589|FG000|Participant Flow|Teriparatide|Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
11081165|NCT01473589|FG001|Participant Flow|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081166|NCT01473589|OG000|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081167|NCT01473589|OG001|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081168|NCT01473589|EG000|Reported Event|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081169|NCT01473589|EG001|Reported Event|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081170|NCT01473589|EG002|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081171|NCT01473589|EG003|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081172|NCT01473602|BG000|Baseline|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
11081173|NCT01473602|BG001|Baseline|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081174|NCT01473602|BG002|Baseline|Total|Total of all reporting groups
11081175|NCT01473602|FG000|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
11081176|NCT01473602|FG001|Participant Flow|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081177|NCT01473602|OG000|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
11081178|NCT01473602|OG001|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081179|NCT01473602|EG000|Reported Event|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081180|NCT01473602|EG001|Reported Event|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
11081181|NCT01473602|EG002|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
11081182|NCT01473602|EG003|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
11081183|NCT01473745|BG000|Baseline|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
11081184|NCT01473745|BG001|Baseline|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
11081185|NCT01473745|BG002|Baseline|Total|Total of all reporting groups
11081186|NCT01473745|FG000|Participant Flow|Conventional Alar Cinch Group|Patients received conventional alar base cinch technique during LeFort I osteotomy procedure.
11081187|NCT01473745|FG001|Participant Flow|Modified Alar Cinch Group|Patients received modified alar base cinch technique during LeFort I osteotomy procedure.
11081188|NCT01473745|OG000|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
11081189|NCT01473745|OG001|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
11081190|NCT01473745|EG000|Reported Event|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from not only ANS and nasalis muscle, but also through the dermis layer of the alar base.~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
11081191|NCT01473745|EG001|Reported Event|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) and nasalis muscle intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
11081192|NCT01473758|BG000|Baseline|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
11081193|NCT01473758|BG001|Baseline|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
11081194|NCT01473758|BG002|Baseline|Total|Total of all reporting groups
11081195|NCT01473758|FG000|Participant Flow|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
11081196|NCT01473758|FG001|Participant Flow|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
11081197|NCT01473758|FG002|Participant Flow|Roflumilast 500 µg (Cycle 2)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
11081198|NCT01473758|FG003|Participant Flow|Placebo (Cycle 2)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
11081199|NCT01473758|OG000|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
11081200|NCT01473758|OG001|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
11081201|NCT01473758|EG000|Reported Event|Roflumilast 500 μg (Initial Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
11081202|NCT01473758|EG001|Reported Event|Placebo (Initial Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
11081203|NCT01473758|EG002|Reported Event|Roflumilast 500 µg (Extended Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
11081204|NCT01473758|EG003|Reported Event|Placebo (Extended Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
11081205|NCT01473836|BG000|Baseline|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
11081206|NCT01473836|FG000|Participant Flow|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
11081207|NCT01473836|OG000|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
11150379|NCT01877408|OG000|Outcome|Physicians|The generalist doctors in this study were moderately experienced in open surgical circumcision but had not previously used the Unicirc instruments.
11150380|NCT01877408|EG000|Reported Event|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
11150381|NCT01877408|EG001|Reported Event|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
11081208|NCT01473836|EG000|Reported Event|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
11081209|NCT01473940|BG000|Baseline|Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081210|NCT01473940|BG001|Baseline|Cohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081211|NCT01473940|BG002|Baseline|Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081212|NCT01473940|BG003|Baseline|Expansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081213|NCT01473940|BG004|Baseline|Total|Total of all reporting groups
11081214|NCT01473940|FG000|Participant Flow|Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081215|NCT01473940|FG001|Participant Flow|Cohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081216|NCT01473940|FG002|Participant Flow|Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081217|NCT01473940|FG003|Participant Flow|Expansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081218|NCT01473940|OG000|Outcome|Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11150382|NCT01877421|BG000|Baseline|Phase 1, 1a (2mg)|Subjects from phase 1, 1a (2mg) group
11150383|NCT01877421|BG001|Baseline|Phase 1, 1a Placebo|Subjects from phase 1, 1a placebo group
11150384|NCT01877421|BG002|Baseline|Phase 1, 2a (4mg)|Subjects from phase 1, 2a (4mg) group
11150385|NCT01877421|BG003|Baseline|Phase 1, 2a Placebo|Subjects from phase 1, 2a (4mg) group
11150386|NCT01877421|BG004|Baseline|Phase 1, 3a (6mg)|Subject from phase 1, 3a (6mg) group
11150387|NCT01877421|BG005|Baseline|Phase 1, 3a Placebo|Subjects from phase 1, 3a placebo gorup
11150388|NCT01877421|BG006|Baseline|Phase 1, 4a (10mg)|Subjects from phase 1, 4a (10mg) group
11150389|NCT01877421|BG007|Baseline|Phase 1, 4a Placebo|Subjects from phase 1, 4a placebo group
11150390|NCT01877421|BG008|Baseline|Phase 1, 5a (20mg)|Subjects from phase 1, 5a (20mg) group
11150391|NCT01877421|BG009|Baseline|Phase 1, 5a Placebo|Subjects from phase1, 5a placebo group
11150392|NCT01877421|BG010|Baseline|Phase 1, 6a (30mg)|Subjects from phase 1, 6a (30mg) group
11150393|NCT01877421|BG011|Baseline|Phase 1, 6a Placebo|Subjects from phase 1, 6a placebo group
11081219|NCT01473940|OG001|Outcome|Cohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081220|NCT01473940|OG002|Outcome|Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081221|NCT01473940|OG003|Outcome|Expansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081222|NCT01473940|OG001|Outcome|Cohort 2/Expansion Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081223|NCT01473940|OG001|Outcome|Cohort 2 Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081224|NCT01473940|OG003|Outcome|Expansion - Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081225|NCT01473940|EG000|Reported Event|Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081226|NCT01473940|EG001|Reported Event|Cohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081227|NCT01473940|EG002|Reported Event|Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081228|NCT01473940|EG003|Reported Event|Expansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|"INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.~MAINTENANCE: Beginning in week 12, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.~Ipilimumab: Given IV~Gemcitabine hydrochloride: Given IV"
11081229|NCT01473953|BG000|Baseline|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
11081230|NCT01473953|BG001|Baseline|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
11081231|NCT01473953|BG002|Baseline|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
11081232|NCT01473953|BG003|Baseline|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
11081233|NCT01473953|BG004|Baseline|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
11081234|NCT01473953|BG005|Baseline|Total|Total of all reporting groups
11081235|NCT01473953|FG000|Participant Flow|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
11081236|NCT01473953|FG001|Participant Flow|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
11081237|NCT01473953|FG002|Participant Flow|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
11081238|NCT01473953|FG003|Participant Flow|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
11081239|NCT01473953|FG004|Participant Flow|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
11081240|NCT01473953|OG000|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
11081241|NCT01473953|OG001|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
11081242|NCT01473953|OG002|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
11081243|NCT01473953|OG003|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
11081244|NCT01473953|OG004|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
11081245|NCT01473953|EG000|Reported Event|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
11081246|NCT01473953|EG001|Reported Event|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
11081247|NCT01473953|EG002|Reported Event|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
11081248|NCT01473953|EG003|Reported Event|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
11081249|NCT01473953|EG004|Reported Event|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
11349126|NCT04117607|FG010|Participant Flow|MAD4|"200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, each injection will be administered in the same quadrant (separated by approximately 5 cm) and each separate dose will be administered into different abdominal quadrants (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.~Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol."
11081250|NCT01473992|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Otto Bock C-Leg (prosthetic knee 1), amputees' preferred prosthetic knee, first and Otto Bock Genium (prosthetic knee 2), the study knee, first.
11081251|NCT01473992|BG001|Baseline|Non Amputee Control Group|non-amputee healty controls
11081252|NCT01473992|BG002|Baseline|Total|Total of all reporting groups
11081253|NCT01473992|FG000|Participant Flow|Prosthetic Knee 1 Then Prosthetic Knee 2|Otto Bock C-Leg: Amputees' preferred prosthetic knee then experimental knee (Genium).
11081254|NCT01473992|FG001|Participant Flow|Prosthetic Knee 2 Then Prosthetic Knee 1|Experimental knee (Otto Bock Genium: Study knee) then subjects' preferred knee (C-Leg).
11081255|NCT01473992|FG002|Participant Flow|Control (Non-amputees)|Non-amputee control group
11081256|NCT01473992|OG000|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
11081257|NCT01473992|OG001|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
11081258|NCT01473992|OG002|Outcome|Non Amputee Control Group|healthy, non-amputee controls
11081259|NCT01473992|OG002|Outcome|Non Amputee Control Group|healthy, non-amputee control group
11081260|NCT01473992|EG000|Reported Event|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
11081261|NCT01473992|EG001|Reported Event|Prosthetic Knee 2|Otto Bock Genium: Study knee.
11081262|NCT01474018|BG000|Baseline|Metformin + Insulin|"5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise and nutrition counseling.~No Change"
11081263|NCT01474018|BG001|Baseline|QR-Bromocriptine +Metformin+Insulin|"study drug add-on the usual therapy~QR-bromocriptine: The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study."
11081264|NCT01474018|BG002|Baseline|Total|Total of all reporting groups
11081265|NCT01474018|FG000|Participant Flow|Metformin + Insulin|"5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise and nutrition counseling.~Study has completed"
11081266|NCT01474018|FG001|Participant Flow|QR-Bromocriptine +Metformin+Insulin|"study drug add-on the usual therapy~QR-bromocriptine: The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study."
11081267|NCT01474018|OG000|Outcome|Metformin + Insulin|5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise / nutrition counseling.
11081268|NCT01474018|OG001|Outcome|QR-Bromocriptine + Metformin + Insulin|study drug add-on to usual therapy with insulin + metformin + exercise / nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The titration was stopped when the patient reported side effects and the dose was subsequently reduced to the highest tolerable dose at which the side effect did not occur. The patient maintained this dose for the duration of the 24-week treatment period.
11081269|NCT01474018|EG000|Reported Event|Metformin + Insulin|5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise / nutrition counseling.
11150394|NCT01877421|BG012|Baseline|Phase 1, 7a (50mg)|Subjects from phase 1, 7a (50mg) group
11081270|NCT01474018|EG001|Reported Event|QR-Bromocriptine + Metformin + Insulin|study drug add-on to usual therapy with insulin + metformin + exercise / nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The titration was stopped when the patient reported side effects and the dose was subsequently reduced to the highest tolerable dose at which the side effect did not occur. The patient maintained this dose for the duration of the 24-week treatment period.
11081271|NCT01474109|BG000|Baseline|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
11081272|NCT01474109|BG001|Baseline|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
11081273|NCT01474109|BG002|Baseline|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
11081274|NCT01474109|BG003|Baseline|Total|Total of all reporting groups
11081275|NCT01474109|FG000|Participant Flow|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
11081276|NCT01474109|FG001|Participant Flow|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
11081277|NCT01474109|FG002|Participant Flow|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
11081278|NCT01474109|OG000|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
11081279|NCT01474109|OG001|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
11081280|NCT01474109|OG002|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
11081281|NCT01474109|EG000|Reported Event|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
11081282|NCT01474109|EG001|Reported Event|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
11081283|NCT01474109|EG002|Reported Event|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
11081284|NCT01474122|BG000|Baseline|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
11081285|NCT01474122|BG001|Baseline|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
11081286|NCT01474122|BG002|Baseline|Placebo|Patients received placebo once daily.
11081287|NCT01474122|BG003|Baseline|Total|Total of all reporting groups
11081288|NCT01474122|FG000|Participant Flow|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
11081289|NCT01474122|FG001|Participant Flow|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
11081290|NCT01474122|FG002|Participant Flow|Placebo|Patients received placebo once daily.
11081291|NCT01474122|OG000|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
11081292|NCT01474122|OG001|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
11081293|NCT01474122|OG002|Outcome|Placebo|Patients received placebo once daily.
11081294|NCT01474122|OG000|Outcome|Macitentan 3mg|Patients received macitentan 3mg once daily.
11081295|NCT01474122|OG001|Outcome|Macitentan 10mg|Patients received macitentan 10mg once daily.
11081296|NCT01474122|EG000|Reported Event|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
11081297|NCT01474122|EG001|Reported Event|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
11081298|NCT01474122|EG002|Reported Event|Placebo|Patients received placebo once daily.
11081299|NCT01474200|BG000|Baseline|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
11081300|NCT01474200|BG001|Baseline|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
11081301|NCT01474200|BG002|Baseline|Total|Total of all reporting groups
11081302|NCT01474200|FG000|Participant Flow|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
11081303|NCT01474200|FG001|Participant Flow|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
11091961|NCT01536951|FG000|Participant Flow|Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104|"First Intervention: Placebo tablets [matching 20-mg LY3009104] administered orally once.~Second Intervention: 30-mg LY3009104 dose administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
11150395|NCT01877421|BG013|Baseline|Phase 1, 7a Placebo|Subjects from phase 1, 7a placebo group
11081304|NCT01474200|OG000|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
11081305|NCT01474200|OG001|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
11081306|NCT01474200|EG000|Reported Event|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
11081307|NCT01474200|EG001|Reported Event|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
11081308|NCT01474213|BG000|Baseline|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
11081309|NCT01474213|BG001|Baseline|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
11081310|NCT01474213|BG002|Baseline|Total|Total of all reporting groups
11081311|NCT01474213|FG000|Participant Flow|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
11081312|NCT01474213|FG001|Participant Flow|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
11150396|NCT01877421|BG014|Baseline|Phase 1, 8a (75mg)|Subjects from phase 1, 8a (75mg) group
11150397|NCT01877421|BG015|Baseline|Phase 1, 8a Placebo|Subjects from phase 1, 8a placebo group
11150398|NCT01877421|BG016|Baseline|Phase 1, 9a (100mg)|Subjects from phase 1, 9a (100mg) group
11150399|NCT01877421|BG017|Baseline|Phase 1, 9a Placebo|Subjects from phase 1, 9a placebo group
11150400|NCT01877421|BG018|Baseline|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
11150401|NCT01877421|BG019|Baseline|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
11150402|NCT01877421|BG020|Baseline|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
11150403|NCT01877421|BG021|Baseline|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
11150404|NCT01877421|BG022|Baseline|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
11150405|NCT01877421|BG023|Baseline|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
11150406|NCT01877421|BG024|Baseline|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
11150407|NCT01877421|BG025|Baseline|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
11150408|NCT01877421|BG026|Baseline|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
11150409|NCT01877421|BG027|Baseline|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
11150410|NCT01877421|BG028|Baseline|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
11150411|NCT01877421|BG029|Baseline|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
11150412|NCT01877421|BG030|Baseline|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
11150413|NCT01877421|BG031|Baseline|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
11150414|NCT01877421|BG032|Baseline|Total|Total of all reporting groups
11150415|NCT01877421|FG000|Participant Flow|2mg KSL-W|2mg KSL-W
11150416|NCT01877421|FG001|Participant Flow|2mg Placebo|2mg Placebo
11150417|NCT01877421|FG002|Participant Flow|4mg KSL-W|4mg KSL-W
11150418|NCT01877421|FG003|Participant Flow|4mg Placebo|4mg Placebo
11150419|NCT01877421|FG004|Participant Flow|6mg KSL-W|6mg KSL-W
11150420|NCT01877421|FG005|Participant Flow|6mg Placebo|6mg Placebo
11150421|NCT01877421|FG006|Participant Flow|10mg KSL-W|10mg KSL-W
11150422|NCT01877421|FG007|Participant Flow|10mg Placebo|10mg Placebo
11150423|NCT01877421|FG008|Participant Flow|20mg KSL-W|20mg KSL-W
11150424|NCT01877421|FG009|Participant Flow|20mg Placebo|20mg Placebo
11150425|NCT01877421|FG010|Participant Flow|30mg KSL-W|30mg KSL-W
11150426|NCT01877421|FG011|Participant Flow|30mg Placebo|30mg Placebo
11150427|NCT01877421|FG012|Participant Flow|50mg KSL-W|50mg KSL-W
11150428|NCT01877421|FG013|Participant Flow|50mg Placebo|50mg Placebo
11081313|NCT01474213|OG000|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
11081314|NCT01474213|OG001|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
11081315|NCT01474213|OG000|Outcome|Remifetanil Target Controlled Infusion|Two patients in remifentanil group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
11081316|NCT01474213|OG001|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Three patients in dexmedetomidine group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
11081317|NCT01474213|OG000|Outcome|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site (had equilibrated with the plasma concentration, until the desired level of sedation was reached.
11081318|NCT01474213|OG001|Outcome|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
11081319|NCT01474213|EG000|Reported Event|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
11081320|NCT01474213|EG001|Reported Event|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
11081321|NCT01474239|BG000|Baseline|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
11081322|NCT01474239|BG001|Baseline|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
11081323|NCT01474239|BG002|Baseline|Total|Total of all reporting groups
11081324|NCT01474239|FG000|Participant Flow|Bevacizumab|Participants received bevacizumab 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
11081325|NCT01474239|FG001|Participant Flow|Fotemustine|Participants received fotemustine 75 milligrams per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
11081326|NCT01474239|OG000|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
11081327|NCT01474239|OG001|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
11081328|NCT01474239|EG000|Reported Event|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
11081329|NCT01474239|EG001|Reported Event|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
11081330|NCT01474291|BG000|Baseline|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
11081331|NCT01474291|BG001|Baseline|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
11081332|NCT01474291|BG002|Baseline|Total|Total of all reporting groups
11081333|NCT01474291|FG000|Participant Flow|All Tocilizumab|Tocilizumab (RoActemra/Actemra) administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
11081334|NCT01474291|OG000|Outcome|All Tocilizumab|Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
11081335|NCT01474291|OG000|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
11081336|NCT01474291|OG001|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
11081337|NCT01474291|EG000|Reported Event|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
11081338|NCT01474291|EG001|Reported Event|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
11091962|NCT01536951|FG001|Participant Flow|Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo|"First Intervention: 20-mg LY3009104 dose administered orally once.~Second Intervention: 30-mg LY3009104 dose administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
11150429|NCT01877421|FG014|Participant Flow|75mg KSL-W|75mg KSL-W
11081339|NCT01474317|BG000|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
11081340|NCT01474317|FG000|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
11081341|NCT01474317|OG000|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
11081342|NCT01474317|EG000|Reported Event|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
11081343|NCT01474434|BG000|Baseline|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
11081344|NCT01474434|BG001|Baseline|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
11081345|NCT01474434|BG002|Baseline|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
11081346|NCT01474434|BG003|Baseline|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
11081347|NCT01474434|BG004|Baseline|Total|Total of all reporting groups
11081348|NCT01474434|FG000|Participant Flow|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
11081349|NCT01474434|FG001|Participant Flow|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
11081350|NCT01474434|FG002|Participant Flow|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
11081351|NCT01474434|FG003|Participant Flow|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
11081352|NCT01474434|OG000|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
11150430|NCT01877421|FG015|Participant Flow|75mg Placebo|75mg Placebo
11150431|NCT01877421|FG016|Participant Flow|100mg KSL-W|100mg KSL-W
11081353|NCT01474434|OG001|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
11081354|NCT01474434|OG000|Outcome|Part B: Pradigastat (LCQ908)|
11081355|NCT01474434|OG001|Outcome|Part B: Placebo|
11081356|NCT01474434|OG000|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
11081357|NCT01474434|OG001|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
11081358|NCT01474434|OG002|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
11081359|NCT01474434|OG003|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
11081360|NCT01474434|EG000|Reported Event|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
11081361|NCT01474434|EG001|Reported Event|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
11081362|NCT01474434|EG002|Reported Event|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
11081363|NCT01474434|EG003|Reported Event|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
11081364|NCT01474486|BG000|Baseline|Micronutrients|Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
11081365|NCT01474486|FG000|Participant Flow|Micronutrients|Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
11081366|NCT01474486|OG000|Outcome|Micronutrients|"Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)~Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b"
11081367|NCT01474486|OG000|Outcome|Micronutrients|Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid & pyridoxine, 100 microgram (mcg) folic acid, & 50 mcg cyanocobalamin (B12) & biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
11081368|NCT01474486|OG000|Outcome|Micronutrients|"Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tabdaily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)~Micronutrients: Thiamin one tab daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50"
11150432|NCT01877421|FG017|Participant Flow|100mg Placebo|100mg Placebo
11150433|NCT01877421|OG000|Outcome|Phase 1, 1a (2mg)|Subjects from phase 1, 1a (2mg) group
11150434|NCT01877421|OG001|Outcome|Phase 1, 1a Placebo|Subjects from phase 1, 1a placebo group
11150435|NCT01877421|OG002|Outcome|Phase 1, 2a (4mg)|Subjects from phase 1, 2a (4mg) group
11150436|NCT01877421|OG003|Outcome|Phase 1, 2a Placebo|Subjects from phase 1, 2a (4mg) group
11150437|NCT01877421|OG004|Outcome|Phase 1, 3a (6mg)|Subject from phase 1, 3a (6mg) group
11081369|NCT01474486|OG000|Outcome|Micronutrients|"Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg) folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tab daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)~Micronutrients: Thiamin one tab daily provides 50 mg of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 IU tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tab daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)"
11081370|NCT01474486|OG000|Outcome|Micronutrients|"Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg) folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tab daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)~Micronutrients: Thiamin one tab daily provides 50 mg of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 IU tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)"
11081371|NCT01474486|EG000|Reported Event|Micronutrients|Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid & pyridoxine, 100 microgram (mcg) folic acid, & 50 mcg cyanocobalamin (B12) & biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
11081372|NCT01474512|BG000|Baseline|Placebo|Placebo administered as 2 SC injections Q2W up to Week 10.
11081373|NCT01474512|BG001|Baseline|Ixe Q4W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W.
11081374|NCT01474512|BG002|Baseline|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Week 10.
11081375|NCT01474512|BG003|Baseline|Total|Total of all reporting groups
11081376|NCT01474512|FG000|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections at week 0 then 1 PBO (SC) injection every 2 weeks (Q2W) up to Week 10.
11081377|NCT01474512|FG001|Participant Flow|Ixe Q4W - Induction Period|160 milligrams (mg) ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
11081378|NCT01474512|FG002|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10.
11081379|NCT01474512|FG003|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11081380|NCT01474512|FG004|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. Pbo injection was given in between doses Q4W to maintain blindness.
11081381|NCT01474512|FG005|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081382|NCT01474512|FG006|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11081383|NCT01474512|FG007|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081384|NCT01474512|FG008|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081385|NCT01474512|FG009|Participant Flow|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081386|NCT01474512|FG010|Participant Flow|Ixe Q4W - Maintenance Period Relapsed Population|Participants who relapsed during maintenance period prior to long term received, Ixe 80 mg as 1 SC injection Q4W for the remainder of the study to evaluate whether the response observed earlier could be regained on treatment with a higher dose.
11081387|NCT01474512|FG011|Participant Flow|Placebo Long-Term Extension (LTE)|Participants who received placebo at the start of the long-term extension period and remained on placebo. Participants who received placebo at the start of long-term extension period (Week 60) then switched to Ixe.
11081388|NCT01474512|FG012|Participant Flow|Ixe Long-Term Extension|Participants who received 80 mg ixe in all dosing regimens at the start of the long-term extension period from Week 60 to Week 264.
11081389|NCT01474512|FG013|Participant Flow|Total Ixe Long-Term Extension|Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in long-term extension (LTE) period.
11081390|NCT01474512|FG014|Participant Flow|Placebo Post-Treatment Follow-Up|Participants who received PBO prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11081391|NCT01474512|FG015|Participant Flow|Ixe Q12W Post-Treatment Follow-Up|Participants who received 80 mg ixe 1 SC injection Q12W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11081392|NCT01474512|FG016|Participant Flow|Ixe Q4W Post-Treatment Follow-Up|Participants who received 80 mg ixe Q4W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11081393|NCT01474512|FG017|Participant Flow|Ixe Q2W Post-Treatment Follow-Up|Participants who received 80 mg ixe Q2W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11081394|NCT01474512|OG000|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
11081395|NCT01474512|OG001|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
11081396|NCT01474512|OG002|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
11081397|NCT01474512|OG000|Outcome|Ixe/Placebo|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
11081398|NCT01474512|OG001|Outcome|Ixe/Q12W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56 (Maintenance Period).
11081399|NCT01474512|OG002|Outcome|Ixe/Q4W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
11081400|NCT01474512|OG000|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
11081401|NCT01474512|OG001|Outcome|Ixe Q4W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
11081402|NCT01474512|OG002|Outcome|Ixe Q4W - Maintenance Period|80 mg ixe administered as 1 SC injection Q4W from Week 12 up to Week 60
11081403|NCT01474512|OG003|Outcome|Ixe Q12W - Maintenance Period|80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
11081404|NCT01474512|EG000|Reported Event|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections at week 0 then 1 PBO (SC) injection every 2 weeks (Q2W) up to Week 10.
11081405|NCT01474512|EG001|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W. Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
11081406|NCT01474512|EG002|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Weeks 2, 4, 6, 8 and 10.
11081407|NCT01474512|EG003|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11081408|NCT01474512|EG004|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56. Pbo injection was given in between doses Q4W to maintain blindness.
11081409|NCT01474512|EG005|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081410|NCT01474512|EG006|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
11081411|NCT01474512|EG007|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081412|NCT01474512|EG008|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081413|NCT01474512|EG009|Reported Event|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081414|NCT01474512|EG010|Reported Event|Ixe Q4W - Maintenance Period Relapse Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11081415|NCT01474512|EG011|Reported Event|Placebo Long-Term Extension|Participants who received placebo at the start of the long-term extension period and remained on placebo. Participants who received placebo at the start of long-term extension (Week 60) then switched to Ixe.
11081416|NCT01474512|EG012|Reported Event|Ixe Long-Term Extension|Participants who received 80 mg ixe in all dosing regimen at the start of the long-term extension period from Week 60 to Week 264
11081417|NCT01474512|EG013|Reported Event|Total Ixe Long-Term Extension|Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in LTE period.
11081418|NCT01474512|EG014|Reported Event|Placebo Post-Treatment Follow-Up|Participants who received PBO prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11081419|NCT01474512|EG015|Reported Event|Ixe Q12W Post-Treatment Follow-Up|Participants who received 80 mg ixe Q12W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11081420|NCT01474512|EG016|Reported Event|Ixe Q4W Post Treatment Follow-Up|Participants who received 80 mg ixe Q4W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11081421|NCT01474512|EG017|Reported Event|Ixe Q2W Post-Treatment Follow-Up|Participants who received 80 mg ixe Q2W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
11081422|NCT01474538|BG000|Baseline|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
11081423|NCT01474538|BG001|Baseline|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
11081424|NCT01474538|BG002|Baseline|Total|Total of all reporting groups
11081425|NCT01474538|FG000|Participant Flow|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
11081426|NCT01474538|FG001|Participant Flow|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
11081427|NCT01474538|OG000|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
11081428|NCT01474538|OG001|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
11081429|NCT01474538|EG000|Reported Event|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
11081430|NCT01474538|EG001|Reported Event|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
11081431|NCT01474551|BG000|Baseline|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
11081432|NCT01474551|FG000|Participant Flow|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
11081433|NCT01474551|OG000|Outcome|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
11081434|NCT01474551|EG000|Reported Event|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
11081435|NCT01474590|BG000|Baseline|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
11081436|NCT01474590|BG001|Baseline|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
11081437|NCT01474590|BG002|Baseline|Total|Total of all reporting groups
11081438|NCT01474590|FG000|Participant Flow|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
11081439|NCT01474590|FG001|Participant Flow|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
11081440|NCT01474590|OG000|Outcome|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
11081441|NCT01474590|OG001|Outcome|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
11081442|NCT01474590|EG000|Reported Event|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
11081443|NCT01474590|EG001|Reported Event|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
11081444|NCT01474681|BG000|Baseline|SUCBT|Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
11150438|NCT01877421|OG005|Outcome|Phase 1, 3a Placebo|Subjects from phase 1, 3a placebo gorup
11081445|NCT01474681|BG001|Baseline|DUCBT|Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
11081446|NCT01474681|BG002|Baseline|Total|Total of all reporting groups
11081447|NCT01474681|FG000|Participant Flow|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
11081448|NCT01474681|FG001|Participant Flow|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
11081449|NCT01474681|FG002|Participant Flow|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
11081450|NCT01474681|FG003|Participant Flow|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
11081451|NCT01474681|OG000|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
11081452|NCT01474681|OG001|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
11081453|NCT01474681|OG002|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
11081454|NCT01474681|OG003|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
11081455|NCT01474681|OG000|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
11081456|NCT01474681|OG001|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
11081457|NCT01474681|EG000|Reported Event|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
11081458|NCT01474681|EG001|Reported Event|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
11081459|NCT01474681|EG002|Reported Event|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
11081460|NCT01474681|EG003|Reported Event|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
11081461|NCT01474681|EG004|Reported Event|SUCBT|Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
11081462|NCT01474681|EG005|Reported Event|DUCBT|Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
11081463|NCT01474746|BG000|Baseline|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
11081464|NCT01474746|BG001|Baseline|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
11081465|NCT01474746|BG002|Baseline|Total|Total of all reporting groups
11081466|NCT01474746|FG000|Participant Flow|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
11081467|NCT01474746|FG001|Participant Flow|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
11081468|NCT01474746|OG000|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
11081469|NCT01474746|OG001|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
11081470|NCT01474746|EG000|Reported Event|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
11081471|NCT01474746|EG001|Reported Event|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
11081472|NCT01474772|BG000|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11150439|NCT01877421|OG006|Outcome|Phase 1, 4a (10mg)|Subjects from phase 1, 4a (10mg) group
11081473|NCT01474772|BG001|Baseline|Placebo/Pregabalin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11081474|NCT01474772|BG002|Baseline|Total|Total of all reporting groups
11081475|NCT01474772|FG000|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11081476|NCT01474772|FG001|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11081477|NCT01474772|OG000|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11081478|NCT01474772|OG001|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11081479|NCT01474772|EG000|Reported Event|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11081480|NCT01474772|EG001|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
11081481|NCT01474863|BG000|Baseline|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
11081482|NCT01474863|BG001|Baseline|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
11081483|NCT01474863|BG002|Baseline|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
11081484|NCT01474863|BG003|Baseline|Total|Total of all reporting groups
11081485|NCT01474863|FG000|Participant Flow|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
11081486|NCT01474863|FG001|Participant Flow|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
11081487|NCT01474863|FG002|Participant Flow|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
11081488|NCT01474863|OG000|Outcome|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
11081489|NCT01474863|OG001|Outcome|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
11081490|NCT01474863|OG002|Outcome|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
11150440|NCT01877421|OG007|Outcome|Phase 1, 4a Placebo|Subjects from phase 1, 4a placebo group
11150441|NCT01877421|OG008|Outcome|Phase 1, 5a (20mg)|Subjects from phase 1, 5a (20mg) group
11081491|NCT01474863|EG000|Reported Event|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
11081492|NCT01474863|EG001|Reported Event|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
11081493|NCT01474863|EG002|Reported Event|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
11081494|NCT01474876|BG000|Baseline|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
11081495|NCT01474876|BG001|Baseline|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
11081496|NCT01474876|BG002|Baseline|Disease State Unknown|For one participant, information regarding the underlying disease was not available
11081497|NCT01474876|BG003|Baseline|Total|Total of all reporting groups
11081498|NCT01474876|FG000|Participant Flow|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
11081499|NCT01474876|FG001|Participant Flow|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
11081500|NCT01474876|FG002|Participant Flow|Disease State Unknown|For one participant, information regarding the underlying disease was not available
11081501|NCT01474876|OG000|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
11081502|NCT01474876|OG001|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
11081503|NCT01474876|OG000|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
11081504|NCT01474876|EG000|Reported Event|Overall Study Population|Participants who received adalimumab treatment
11081505|NCT01474915|BG000|Baseline|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
11081506|NCT01474915|BG001|Baseline|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
11081507|NCT01474915|BG002|Baseline|Total|Total of all reporting groups
11081508|NCT01474915|FG000|Participant Flow|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
11081509|NCT01474915|FG001|Participant Flow|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
11081510|NCT01474915|OG000|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
11081511|NCT01474915|OG001|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
11150442|NCT01877421|OG009|Outcome|Phase 1, 5a Placebo|Subjects from phase1, 5a placebo group
11150443|NCT01877421|OG010|Outcome|Phase 1, 6a (30mg)|Subjects from phase 1, 6a (30mg) group
11150444|NCT01877421|OG011|Outcome|Phase 1, 6a Placebo|Subjects from phase 1, 6a placebo group
11150445|NCT01877421|OG012|Outcome|Phase 1, 7a (50mg)|Subjects from phase 1, 7a (50mg) group
11150446|NCT01877421|OG013|Outcome|Phase 1, 7a Placebo|Subjects from phase 1, 7a placebo group
11150447|NCT01877421|OG014|Outcome|Phase 1, 8a (75mg)|Subjects from phase 1, 8a (75mg) group
11081512|NCT01474915|OG000|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
11081513|NCT01474915|EG000|Reported Event|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
11081514|NCT01474915|EG001|Reported Event|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
11091963|NCT01536951|FG002|Participant Flow|Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104|"First Intervention: 20-mg LY3009104 dose administered orally once.~Second Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
11091964|NCT01536951|FG003|Participant Flow|Part B: 40 mg LY3009104, Placebo, Moxifloxacin|"First Intervention: 40-mg LY3009104 dose administered orally once.~Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.~There was a washout of at least 3 days between each intervention."
11091965|NCT01536951|FG004|Participant Flow|Part B: Placebo, Moxifloxacin, 40 mg LY3009104|"First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
11091966|NCT01536951|FG005|Participant Flow|Part B: Moxifloxacin, 40 mg LY3009104, Placebo|"First Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Second Intervention: 40-mg LY3009104 dose administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
11091967|NCT01536951|FG006|Participant Flow|Part B: Moxifloxacin, Placebo, 40 mg LY3009104|"First Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
11091968|NCT01536951|FG007|Participant Flow|Part B: 40 mg LY3009104, Moxifloxacin, Placebo|"First Intervention: 40-mg LY3009104 dose administered orally once.~Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
11091969|NCT01536951|FG008|Participant Flow|Part B: Placebo, 40 mg LY3009104, Moxifloxacin|"First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Second Intervention: 40-mg LY3009104 dose administered orally once.~Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.~There was a washout of at least 3 days between each intervention."
11091970|NCT01536951|OG000|Outcome|Part B: Placebo|Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
11091971|NCT01536951|OG001|Outcome|Part B: 40 mg LY3009104|A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
11091972|NCT01536951|OG002|Outcome|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
11091973|NCT01536951|OG000|Outcome|Part A: 20 mg LY3009104|A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
11091974|NCT01536951|OG001|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
11091975|NCT01536951|OG002|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
11091976|NCT01536951|OG003|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
11091977|NCT01536951|OG000|Outcome|Part A: Placebo|Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
11091978|NCT01536951|OG001|Outcome|Part A: 20 mg LY3009104|A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
11091979|NCT01536951|OG002|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
11091980|NCT01536951|OG003|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
11091981|NCT01536951|OG004|Outcome|Part B: Placebo|Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
11091982|NCT01536951|OG005|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
11091983|NCT01536951|OG006|Outcome|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
11091984|NCT01536951|EG000|Reported Event|Part A: Placebo|Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
11081515|NCT01474993|BG000|Baseline|Placebo|15 participants were randomized to placebo.
11081516|NCT01474993|BG001|Baseline|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane.
11081517|NCT01474993|BG002|Baseline|Total|Total of all reporting groups
11081518|NCT01474993|FG000|Participant Flow|Placebo|15 participants were randomized to placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose).One participant in placebo group dropped out before starting study drug. 14 participants completed the study.
11081519|NCT01474993|FG001|Participant Flow|Sulforaphane-rich Broccoli Sprout Extract|"29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study.~Sulforaphane-rich Broccoli Sprout Extract: The medication was supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane depended on subject's body weight:~Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)~Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)~Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)"
11081520|NCT01474993|OG000|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
11081521|NCT01474993|OG001|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
11081522|NCT01474993|OG000|Outcome|Placebo|Inactive placebo.
11081523|NCT01474993|OG001|Outcome|Interventional|Sulforaphane-rich Broccoli Sprout Extract.
11081524|NCT01474993|EG000|Reported Event|Placebo|15 participants were randomized to placebo. One participant in placebo group dropped out before starting study drug. 14 participants completed the study and were analyzed.
11081525|NCT01474993|EG001|Reported Event|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study and were analyzed.
11081526|NCT01475071|BG000|Baseline|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
11081527|NCT01475071|FG000|Participant Flow|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
11081528|NCT01475071|OG000|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
11081529|NCT01475071|OG001|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
11081530|NCT01475071|EG000|Reported Event|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
11081531|NCT01475071|EG001|Reported Event|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
11081532|NCT01475097|BG000|Baseline|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
11081533|NCT01475097|BG001|Baseline|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
11081534|NCT01475097|BG002|Baseline|Total|Total of all reporting groups
11081535|NCT01475097|FG000|Participant Flow|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
11081536|NCT01475097|FG001|Participant Flow|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
11081537|NCT01475097|OG000|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
11081538|NCT01475097|OG001|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
11081539|NCT01475097|EG000|Reported Event|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
11081540|NCT01475097|EG001|Reported Event|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
11081541|NCT01475136|BG000|Baseline|LY2140023-Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of 80 mg LY2140023 on Day 1.
11081542|NCT01475136|BG001|Baseline|LY2140023-Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of 80 mg LY2140023 on Day 1.
11081543|NCT01475136|BG002|Baseline|LY2140023-Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of 80 mg LY2140023 on Day 1.
11081544|NCT01475136|BG003|Baseline|LY2140023-Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of 80 mg LY2140023on Day 1.
11081545|NCT01475136|BG004|Baseline|Total|Total of all reporting groups
11081546|NCT01475136|FG000|Participant Flow|LY2140023-Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of 80 milligrams (mg) LY2140023 on Day 1.
11081547|NCT01475136|FG001|Participant Flow|LY2140023-Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of 80 mg LY2140023 on Day 1.
11081548|NCT01475136|FG002|Participant Flow|LY2140023-Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of 80 mg LY2140023 on Day 1.
11081549|NCT01475136|FG003|Participant Flow|LY2140023-Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of 80 mg LY2140023on Day 1.
11081550|NCT01475136|OG000|Outcome|LY2140023-Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of 80 mg LY2140023 on Day 1.
11081551|NCT01475136|OG001|Outcome|LY2140023-Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of 80 mg LY2140023 on Day 1.
11081552|NCT01475136|OG002|Outcome|LY2140023-Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of 80 mg LY2140023 on Day 1.
11081553|NCT01475136|OG003|Outcome|LY2140023-Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of 80 mg LY2140023on Day 1.
11081554|NCT01475136|EG000|Reported Event|LY2140023-Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of 80 mg LY2140023 on Day 1.
11081555|NCT01475136|EG001|Reported Event|LY2140023-Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of 80 mg LY2140023 on Day 1.
11081556|NCT01475136|EG002|Reported Event|LY2140023-Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of 80 mg LY2140023 on Day 1.
11081557|NCT01475136|EG003|Reported Event|LY2140023-Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of 80 mg LY2140023on Day 1.
11081558|NCT01475162|BG000|Baseline|Tocilizumab|"Drug: Tocilizumab~Other Names:~Actemra~Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks for three doses. After Day 56 doses may be decreased to 4mg/kg once every three weeks depending on GVHD response.~Tocilizumab: Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks for three doses. After Day 56 doses may be decreased to 4mg/kg once every three weeks depending on GVHD response."
11081559|NCT01475162|FG000|Participant Flow|Tocilizumab|"Drug: Tocilizumab Other Names: Actemra~Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks for three doses. After Day 56 doses may be decreased to 4 mg/kg once every three weeks depending on graft versus host disease (GVHD) response."
11081560|NCT01475162|OG000|Outcome|Tocilizumab|"Drug: Tocilizumab Other Names: Actemra~Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks. Patients with documented responses will continue to receive treatment at 8 mg/kg once every 3 weeks for at least two months (day 56). Patients that have some degree of response but without complete resolution of signs and symptoms of acute GVHD may continue to receive 8 mg/kg on a 3-week cycle until complete response is achieved or lack of further improvement. In patients who are beyond day 56 and whose GVHD has resolved, the dose of Tocilizumab will be reduced to 4 mg/kg every 3 weeks."
11081561|NCT01475162|OG000|Outcome|Tocilizumab|"Drug: Tocilizumab Other Names: Actemra~Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks for three doses. After Day 56 doses may be decreased to 4mg/kg once every three weeks depending on GVHD response."
11081562|NCT01475162|EG000|Reported Event|Tocilizumab|"Drug: Tocilizumab Other Names: Actemra~Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks for three doses. After Day 56 doses may be decreased to 4mg/kg once every three weeks depending on GVHD response."
11081563|NCT01475175|BG000|Baseline|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
11081564|NCT01475175|FG000|Participant Flow|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
11081565|NCT01475175|OG000|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
11081566|NCT01475175|EG000|Reported Event|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
11081567|NCT01475214|BG000|Baseline|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
11081568|NCT01475214|BG001|Baseline|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
11081569|NCT01475214|BG002|Baseline|Inactive Placebo Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
11081570|NCT01475214|BG003|Baseline|Total|Total of all reporting groups
11091985|NCT01536951|EG001|Reported Event|Part A: 20 mg LY3009104|A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
11091986|NCT01536951|EG002|Reported Event|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
11081571|NCT01475214|FG000|Participant Flow|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
11081572|NCT01475214|FG001|Participant Flow|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
11081573|NCT01475214|FG002|Participant Flow|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
11081574|NCT01475214|OG000|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
11081575|NCT01475214|OG001|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
11081576|NCT01475214|OG002|Outcome|Inactive Placebo Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
11081577|NCT01475214|OG002|Outcome|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
11081578|NCT01475214|EG000|Reported Event|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
11081579|NCT01475214|EG001|Reported Event|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
11081580|NCT01475214|EG002|Reported Event|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
11081581|NCT01475253|BG000|Baseline|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
11081582|NCT01475253|BG001|Baseline|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
11081583|NCT01475253|BG002|Baseline|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
11081584|NCT01475253|BG003|Baseline|Total|Total of all reporting groups
11081585|NCT01475253|FG000|Participant Flow|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
11081586|NCT01475253|FG001|Participant Flow|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
11081587|NCT01475253|FG002|Participant Flow|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
11081588|NCT01475253|FG003|Participant Flow|LiRIS® 400 mg - Open Label Extension|LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open label extension.
11081589|NCT01475253|OG000|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
11081590|NCT01475253|OG001|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
11081591|NCT01475253|EG000|Reported Event|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
11081592|NCT01475253|EG001|Reported Event|LiRIS® Placebo - Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
11081593|NCT01475253|EG002|Reported Event|Sham Cystoscopic Procedure - Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
11081594|NCT01475253|EG003|Reported Event|LiRIS 400 mg - Open Label Extension|"LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine.~All subjects who completed the randomized study had the option to enter the open lable extension."
11081595|NCT01475305|BG000|Baseline|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
11091987|NCT01536951|EG003|Reported Event|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
11081596|NCT01475305|BG001|Baseline|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
11081597|NCT01475305|BG002|Baseline|Total|Total of all reporting groups
11081598|NCT01475305|FG000|Participant Flow|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
11081599|NCT01475305|FG001|Participant Flow|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
11081600|NCT01475305|OG000|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
11081601|NCT01475305|OG001|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
11081602|NCT01475305|OG000|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
11081603|NCT01475305|EG000|Reported Event|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
11081604|NCT01475305|EG001|Reported Event|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
11081605|NCT01475331|BG000|Baseline|Control Group|"Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
11081606|NCT01475331|BG001|Baseline|Study Group|"Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
11081607|NCT01475331|BG002|Baseline|Total|Total of all reporting groups
11081608|NCT01475331|FG000|Participant Flow|Control Group|"Cyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%). Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.~Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
11081609|NCT01475331|FG001|Participant Flow|Study Group|"Cyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.~Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
11081610|NCT01475331|OG000|Outcome|Control Group|"Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
11081611|NCT01475331|OG001|Outcome|Study Group|"Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
11081612|NCT01475331|EG000|Reported Event|Control Group|"Cyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%). Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.~Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
11081613|NCT01475331|EG001|Reported Event|Study Group|"Cyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.~Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
11081614|NCT01475370|BG000|Baseline|OCV-501 0.3mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
11081615|NCT01475370|BG001|Baseline|OCV-501 1 mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
11081616|NCT01475370|BG002|Baseline|OCV-501 3 mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
11081617|NCT01475370|BG003|Baseline|Total|Total of all reporting groups
11081618|NCT01475370|FG000|Participant Flow|OCV-501 0.3mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
11081619|NCT01475370|FG001|Participant Flow|OCV-501 1 mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
11081620|NCT01475370|FG002|Participant Flow|OCV-501 3 mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
11081621|NCT01475370|OG000|Outcome|OCV-501 0.3mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
11081622|NCT01475370|OG001|Outcome|OCV-501 1 mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
11150448|NCT01877421|OG015|Outcome|Phase 1, 8a Placebo|Subjects from phase 1, 8a placebo group
11081623|NCT01475370|OG002|Outcome|OCV-501 3 mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
11081624|NCT01475370|EG000|Reported Event|OCV-501 0.3mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
11081625|NCT01475370|EG001|Reported Event|OCV-501 1 mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
11081626|NCT01475370|EG002|Reported Event|OCV-501 3 mg|OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
11081627|NCT01475461|BG000|Baseline|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081628|NCT01475461|BG001|Baseline|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081629|NCT01475461|BG002|Baseline|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081630|NCT01475461|BG003|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081631|NCT01475461|BG004|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081632|NCT01475461|BG005|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081633|NCT01475461|BG006|Baseline|Total|Total of all reporting groups
11081634|NCT01475461|FG000|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
11081635|NCT01475461|FG001|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081636|NCT01475461|FG002|Participant Flow|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081637|NCT01475461|FG003|Participant Flow|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081638|NCT01475461|FG004|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081639|NCT01475461|FG005|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081640|NCT01475461|FG006|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081641|NCT01475461|OG000|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081642|NCT01475461|OG001|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081643|NCT01475461|OG002|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081644|NCT01475461|OG003|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081645|NCT01475461|OG004|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081646|NCT01475461|OG005|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081647|NCT01475461|OG000|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
11150449|NCT01877421|OG016|Outcome|Phase 1, 9a (100mg)|Subjects from phase 1, 9a (100mg) group
11150450|NCT01877421|OG017|Outcome|Phase 1, 9a Placebo|Subjects from phase 1, 9a placebo group
11150451|NCT01877421|OG018|Outcome|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
11150452|NCT01877421|OG019|Outcome|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
11150453|NCT01877421|OG020|Outcome|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
11150454|NCT01877421|OG021|Outcome|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
11150455|NCT01877421|OG022|Outcome|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
11150456|NCT01877421|OG023|Outcome|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
11150457|NCT01877421|OG024|Outcome|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
11150458|NCT01877421|OG025|Outcome|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
11150459|NCT01877421|OG026|Outcome|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
11150460|NCT01877421|OG027|Outcome|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
11150461|NCT01877421|OG028|Outcome|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
11150462|NCT01877421|OG029|Outcome|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
11150463|NCT01877421|OG030|Outcome|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
11081648|NCT01475461|OG001|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081649|NCT01475461|OG002|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081650|NCT01475461|OG003|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081651|NCT01475461|OG004|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081652|NCT01475461|OG005|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081653|NCT01475461|OG006|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081654|NCT01475461|OG001|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081655|NCT01475461|OG002|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081656|NCT01475461|OG003|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081657|NCT01475461|OG004|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081658|NCT01475461|OG005|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081659|NCT01475461|OG006|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081660|NCT01475461|OG001|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081661|NCT01475461|OG002|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081662|NCT01475461|OG003|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081663|NCT01475461|OG004|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081664|NCT01475461|OG005|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11150464|NCT01877421|OG031|Outcome|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
11150465|NCT01877421|OG000|Outcome|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
11081665|NCT01475461|EG000|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
11081666|NCT01475461|EG001|Reported Event|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081667|NCT01475461|EG002|Reported Event|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
11081668|NCT01475461|EG003|Reported Event|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081669|NCT01475461|EG004|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081670|NCT01475461|EG005|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081671|NCT01475461|EG006|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11081672|NCT01475474|BG000|Baseline|Renew Insert for Management of Accidental Bowel Leakage|
11081673|NCT01475474|FG000|Participant Flow|Renew Insert for Management of Accidental Bowel Leakage|The Renew Insert is designed for self-insertion to seal and help prevent involuntary leakage of stool from the rectum. The Insert is designed for single use and consists of two components: a soft, easily deformable silicone insert and a flexible plastic fingertip applicator. After self insertion into the anal canal the Insert is expelled with voluntary bowel movement or if desired, manually removed by the user.
11081674|NCT01475474|OG000|Outcome|Modified Intent-To-Treat Cohort|Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
11081675|NCT01475474|OG000|Outcome|Modified Intent to Treat Cohort (MITT)|Modified Intent-to-Treat cohort included all subjects who completed at least one week of Insert use during the 12 Week Treatment Period.
11081676|NCT01475474|EG000|Reported Event|Intent-to-treat (ITT) Cohort|Subjects who used the Renew Insert.
11150466|NCT01877421|OG001|Outcome|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
11150467|NCT01877421|OG002|Outcome|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
11081677|NCT01475487|BG000|Baseline|Cricothyrotomy Using Digital Palpation|"Group-1 will perform Cricothyrotomy using conventional digital palpation technique~Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
11081678|NCT01475487|BG001|Baseline|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy~Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
11081679|NCT01475487|BG002|Baseline|Total|Total of all reporting groups
11081680|NCT01475487|FG000|Participant Flow|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
11081681|NCT01475487|FG001|Participant Flow|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver's neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient's right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
11081682|NCT01475487|OG000|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
11081683|NCT01475487|OG001|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver's neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient's right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
11081684|NCT01475487|EG000|Reported Event|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
11081685|NCT01475487|EG001|Reported Event|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver's neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient's right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
11081686|NCT01475513|BG000|Baseline|African-American Women|"African-American women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081687|NCT01475513|BG001|Baseline|Caucasian Women|"Caucasian women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081688|NCT01475513|BG002|Baseline|Total|Total of all reporting groups
11081689|NCT01475513|FG000|Participant Flow|African-American Women|"African-American women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081690|NCT01475513|FG001|Participant Flow|Caucasian Women|"Caucasian women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081691|NCT01475513|OG000|Outcome|African-American Women|"African-American women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081692|NCT01475513|OG001|Outcome|Caucasian Women|"Caucasian women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11091988|NCT01536951|EG004|Reported Event|Part B: Placebo|Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
11150468|NCT01877421|OG003|Outcome|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
11081693|NCT01475513|OG000|Outcome|African-American Women|"African-American women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) was taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081694|NCT01475513|OG001|Outcome|Caucasian Women|"Caucasian women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) was taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081695|NCT01475513|EG000|Reported Event|African-American Women|"African-American women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) was taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081696|NCT01475513|EG001|Reported Event|Caucasian Women|"Caucasian women~Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) was taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill."
11081697|NCT01475643|BG000|Baseline|Loteprednol Etabonate|"Loteprednol etabonate 0.5%~Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days."
11081698|NCT01475643|BG001|Baseline|Prednisolones Acetate|"Prednisolone acetate 1.0%~Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days."
11081699|NCT01475643|BG002|Baseline|Total|Total of all reporting groups
11081700|NCT01475643|FG000|Participant Flow|Loteprednol Etabonate|"Loteprednol etabonate 0.5%~Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days."
11081701|NCT01475643|FG001|Participant Flow|Prednisolones Acetate|"Prednisolone acetate 1.0%~Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days."
11081702|NCT01475643|OG000|Outcome|Loteprednol Etabonate|"Loteprednol etabonate 0.5%~Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days."
11081703|NCT01475643|OG001|Outcome|Prednisolones Acetate|"Prednisolone acetate 1.0%~Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days."
11081704|NCT01475643|EG000|Reported Event|Loteprednol Etabonate|"Loteprednol etabonate 0.5%~Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days."
11081705|NCT01475643|EG001|Reported Event|Prednisolones Acetate|"Prednisolone acetate 1.0%~Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days."
11081706|NCT01475721|BG000|Baseline|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
11081707|NCT01475721|BG001|Baseline|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
11081708|NCT01475721|BG002|Baseline|Total|Total of all reporting groups
11081709|NCT01475721|FG000|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
11081710|NCT01475721|FG001|Participant Flow|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
11081711|NCT01475721|OG000|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
11081712|NCT01475721|OG001|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
11081713|NCT01475721|EG000|Reported Event|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
11081714|NCT01475721|EG001|Reported Event|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
11091989|NCT01536951|EG005|Reported Event|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
11081715|NCT01475734|BG000|Baseline|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
11081716|NCT01475734|BG001|Baseline|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
11081717|NCT01475734|BG002|Baseline|Total|Total of all reporting groups
11081718|NCT01475734|FG000|Participant Flow|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
11081719|NCT01475734|FG001|Participant Flow|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
11081720|NCT01475734|OG000|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
11081721|NCT01475734|OG001|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
11081722|NCT01475734|EG000|Reported Event|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
11081723|NCT01475734|EG001|Reported Event|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
11081724|NCT01475825|BG000|Baseline|Regimen A: Mipomersen, 200 mg, Once Weekly|Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081725|NCT01475825|BG001|Baseline|Regimen A: Placebo, Once Weekly|Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081726|NCT01475825|BG002|Baseline|Regimen B: Mipomersen, 70 mg, Thrice Weekly|Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081727|NCT01475825|BG003|Baseline|Regimen B: Placebo, Thrice Weekly|Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081728|NCT01475825|BG004|Baseline|Total|Total of all reporting groups
11081729|NCT01475825|FG000|Participant Flow|Regimen A: Mipomersen, 200 mg, Once Weekly|Participants received once weekly subcutaneous (SC) injections of mipomersen sodium 200 milligrams (mg) during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081730|NCT01475825|FG001|Participant Flow|Regimen A: Placebo, Once Weekly|Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081731|NCT01475825|FG002|Participant Flow|Regimen B: Mipomersen, 70 mg, Thrice Weekly|Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081732|NCT01475825|FG003|Participant Flow|Regimen B: Placebo, Thrice Weekly|Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081733|NCT01475825|OG000|Outcome|Regimen A: Mipomersen, 200 mg, Once Weekly|Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081734|NCT01475825|OG001|Outcome|Regimen A: Placebo, Once Weekly|Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081735|NCT01475825|OG002|Outcome|Regimen B: Mipomersen, 70 mg, Thrice Weekly|Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081736|NCT01475825|OG003|Outcome|Regimen B: Placebo, Thrice Weekly|Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081737|NCT01475825|EG000|Reported Event|Regimen A: Mipomersen, 200 mg, Once Weekly|Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081738|NCT01475825|EG001|Reported Event|Regimen A: Placebo, Once Weekly|Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081739|NCT01475825|EG002|Reported Event|Regimen B: Mipomersen, 70 mg, Thrice Weekly|Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081740|NCT01475825|EG003|Reported Event|Regimen B: Placebo, Thrice Weekly|Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
11081741|NCT01475838|BG000|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
11081742|NCT01475838|BG001|Baseline|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
11081743|NCT01475838|BG002|Baseline|Total|Total of all reporting groups
11081744|NCT01475838|FG000|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
11081745|NCT01475838|FG001|Participant Flow|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
11081746|NCT01475838|OG000|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
11081747|NCT01475838|OG001|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
11081748|NCT01475838|EG000|Reported Event|Stribild|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.~Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
11081749|NCT01475838|EG001|Reported Event|PI+RTV+FTC/TDF|"Adverse events for this reporting group include those occurring in participants receiving PI+RTV+FTC/TDF in the randomized phase.~Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
11081750|NCT01475838|EG002|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in participants while receiving Stribild in the randomized and extension phases.
11081751|NCT01475851|BG000|Baseline|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
11081752|NCT01475851|BG001|Baseline|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
11081753|NCT01475851|BG002|Baseline|Total|Total of all reporting groups
11233754|NCT02431052|OG000|Outcome|Olumacostat Glasaretil Gel, Vehicle QD|"Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks~Olumacostat Glasaretil"
11233755|NCT02431052|OG001|Outcome|Olumacostat Glasaretil Gel, Vehicle BID|"Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks~Olumacostat Glasaretil"
11081754|NCT01475851|FG000|Participant Flow|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
11081755|NCT01475851|FG001|Participant Flow|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
11081756|NCT01475851|OG000|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
11081757|NCT01475851|OG001|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
11081758|NCT01475851|EG000|Reported Event|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
11081759|NCT01475851|EG001|Reported Event|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
11081760|NCT01475955|BG000|Baseline|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
11081761|NCT01475955|BG001|Baseline|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
11233756|NCT02431052|OG002|Outcome|Olumacostat Glasaretil Gel, 4.0% QD|"Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks~Olumacostat Glasaretil"
11081762|NCT01475955|BG002|Baseline|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
11081763|NCT01475955|BG003|Baseline|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
11081764|NCT01475955|BG004|Baseline|Vehicle (VEH) + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visit 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11081765|NCT01475955|BG005|Baseline|Total|Total of all reporting groups
11081766|NCT01475955|FG000|Participant Flow|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5
11081767|NCT01475955|FG001|Participant Flow|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
11081768|NCT01475955|FG002|Participant Flow|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
11081769|NCT01475955|FG003|Participant Flow|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
11081770|NCT01475955|FG004|Participant Flow|Vehicle + BLUE Light Treatment|"Vehicle (VEH) group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle (VEH) Photodynamic Therapy (PDT) : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11081771|NCT01475955|OG000|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
11081772|NCT01475955|OG001|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
11081773|NCT01475955|OG002|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
11081774|NCT01475955|OG003|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
11081775|NCT01475955|OG004|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11081776|NCT01475955|OG001|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation,prior to BLUE light treatment at Visits 1 and 5.
11081777|NCT01475955|OG004|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. . Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11233757|NCT02431052|OG003|Outcome|Olumacostat Glasaretil Gel, 7.5% QD|"Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks~Vehicle"
11081778|NCT01475955|OG004|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group were randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11081779|NCT01475955|OG004|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11081780|NCT01475955|OG000|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
11091990|NCT01536951|EG006|Reported Event|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
11081781|NCT01475955|OG001|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
11081782|NCT01475955|OG002|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
11081783|NCT01475955|OG003|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
11081784|NCT01475955|OG004|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment, at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11081785|NCT01475955|OG001|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Vist 1 and Visit 5
11081786|NCT01475955|OG002|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
11081787|NCT01475955|OG003|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
11081788|NCT01475955|OG004|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11081789|NCT01475955|OG001|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
11081790|NCT01475955|OG004|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5 . Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
11081791|NCT01475955|OG000|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
11081792|NCT01475955|OG001|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
11081793|NCT01475955|OG001|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment at Visit 1 and Vi|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
11081794|NCT01475955|OG002|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
11081795|NCT01475955|EG000|Reported Event|Broad Area ALA 1-hour|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation
11081796|NCT01475955|EG001|Reported Event|Broad Area ALA 2-hour|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation
11081797|NCT01475955|EG002|Reported Event|Broad Area ALA 3-hour|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation
11081798|NCT01475955|EG003|Reported Event|Spot ALA 2-hour|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation
11081799|NCT01475955|EG004|Reported Event|Vehicle PDT|"VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group."
11081800|NCT01476202|BG000|Baseline|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
11081801|NCT01476202|BG001|Baseline|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
11081802|NCT01476202|BG002|Baseline|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
11081803|NCT01476202|BG003|Baseline|Total|Total of all reporting groups
11081804|NCT01476202|FG000|Participant Flow|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
11081805|NCT01476202|FG001|Participant Flow|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
11081806|NCT01476202|FG002|Participant Flow|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
11081807|NCT01476202|OG000|Outcome|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
11081808|NCT01476202|OG001|Outcome|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
11081809|NCT01476202|OG002|Outcome|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
11081810|NCT01476202|OG000|Outcome|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered single dose of 2.5 mg nicotine mouth strip.
11081811|NCT01476202|OG001|Outcome|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
11081812|NCT01476202|OG002|Outcome|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
11150469|NCT01877421|OG004|Outcome|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
11081813|NCT01476202|EG000|Reported Event|Nicotine Mouth Strip 2.5 mg|Participants self administered single dose of 2.5 mg nicotine mouth strip.
11081814|NCT01476202|EG001|Reported Event|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
11081815|NCT01476202|EG002|Reported Event|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
11081816|NCT01476267|BG000|Baseline|Single Arm|dalcetrapib: Single oral radiolabeled dose
11081817|NCT01476267|FG000|Participant Flow|Single Arm|dalcetrapib: Single oral radiolabeled dose
11081818|NCT01476267|OG000|Outcome|Single Arm|dalcetrapib: Single oral radiolabeled dose
11081819|NCT01476267|EG000|Reported Event|Single Arm|dalcetrapib: Single oral radiolabeled dose
11081820|NCT01476345|BG000|Baseline|All Participants|A single 0.5 units/kilogram (U/kg) dose of LY2963016 or a single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
11081821|NCT01476345|FG000|Participant Flow|LY/Lantus/LY/Lantus|"Sequence 1: A single 0.5 units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.~A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 2 and 4.~Minimum washout interval of 7 days between each period."
11081822|NCT01476345|FG001|Participant Flow|Lantus/LY/Lantus/LY|"Sequence 2: A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 1 and 3.~A single 0.5 U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.~Minimum washout interval of 7 days between each period."
11081823|NCT01476345|OG000|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
11081824|NCT01476345|OG001|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
11081825|NCT01476345|EG000|Reported Event|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
11081826|NCT01476345|EG001|Reported Event|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
11081827|NCT01476449|BG000|Baseline|Monthly Ranibizumab|"Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.~Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity."
11081828|NCT01476449|BG001|Baseline|Treat and Extend Ranibizumab|"Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically dry, at which point the evaluation and injection interval will be extended.~Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity."
11081829|NCT01476449|BG002|Baseline|Total|Total of all reporting groups
11081830|NCT01476449|FG000|Participant Flow|Monthly Ranibizumab|"Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.~Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity."
11081831|NCT01476449|FG001|Participant Flow|Treat and Extend Ranibizumab|"Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically dry, at which point the evaluation and injection interval will be extended.~Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity."
11081832|NCT01476449|OG000|Outcome|Monthly Ranibizumab|"Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.~Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity."
11081833|NCT01476449|OG001|Outcome|Treat and Extend Ranibizumab|"Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically dry, at which point the evaluation and injection interval will be extended.~Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity."
11081834|NCT01476449|EG000|Reported Event|Monthly Ranibizumab|"Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.~Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity."
11081835|NCT01476449|EG001|Reported Event|Treat and Extend Ranibizumab|"Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically dry, at which point the evaluation and injection interval will be extended.~Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity."
11081836|NCT01476475|BG000|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
11081837|NCT01476475|BG001|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
11081838|NCT01476475|BG002|Baseline|Total|Total of all reporting groups
11081839|NCT01476475|FG000|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously once daily (QD) for 24 weeks. Dose individually adjusted.
11081840|NCT01476475|FG001|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
11081841|NCT01476475|OG000|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
11081842|NCT01476475|OG001|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
11081843|NCT01476475|OG001|Outcome|Insulin Glargine (Lantus® SoloSTAR®)|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
11081844|NCT01476475|EG000|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
11081845|NCT01476475|EG001|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
11081846|NCT01476644|BG000|Baseline|Cohort|Moderate glaucoma with a DDLS (optic disc damage likelihood scale range 1-10 with 10 being worse ) between 5 and 8 in at least one eye.
11150470|NCT01877421|OG005|Outcome|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
11150471|NCT01877421|OG006|Outcome|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
11150472|NCT01877421|OG007|Outcome|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
11150473|NCT01877421|OG008|Outcome|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
11150474|NCT01877421|OG009|Outcome|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
11150475|NCT01877421|OG010|Outcome|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
11150476|NCT01877421|OG011|Outcome|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
11150477|NCT01877421|OG012|Outcome|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
11150478|NCT01877421|OG013|Outcome|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
11150479|NCT01877421|EG000|Reported Event|Phase 1, 1a (2mg)|Subjects from phase 1, 1a (2mg) group
11150480|NCT01877421|EG001|Reported Event|Phase 1, 1a Placebo|Subjects from phase 1, 1a placebo group
11150481|NCT01877421|EG002|Reported Event|Phase 1, 2a (4mg)|Subjects from phase 1, 2a (4mg) group
11150482|NCT01877421|EG003|Reported Event|Phase 1, 2a Placebo|Subjects from phase 1, 2a (4mg) group
11150483|NCT01877421|EG004|Reported Event|Phase 1, 3a (6mg)|Subject from phase 1, 3a (6mg) group
11150484|NCT01877421|EG005|Reported Event|Phase 1, 3a Placebo|Subjects from phase 1, 3a placebo gorup
11150485|NCT01877421|EG006|Reported Event|Phase 1, 4a (10mg)|Subjects from phase 1, 4a (10mg) group
11150486|NCT01877421|EG007|Reported Event|Phase 1, 4a Placebo|Subjects from phase 1, 4a placebo group
11150487|NCT01877421|EG008|Reported Event|Phase 1, 5a (20mg)|Subjects from phase 1, 5a (20mg) group
11150488|NCT01877421|EG009|Reported Event|Phase 1, 5a Placebo|Subjects from phase1, 5a placebo group
11150489|NCT01877421|EG010|Reported Event|Phase 1, 6a (30mg)|Subjects from phase 1, 6a (30mg) group
11150490|NCT01877421|EG011|Reported Event|Phase 1, 6a Placebo|Subjects from phase 1, 6a placebo group
11150491|NCT01877421|EG012|Reported Event|Phase 1, 7a (50mg)|Subjects from phase 1, 7a (50mg) group
11150492|NCT01877421|EG013|Reported Event|Phase 1, 7a Placebo|Subjects from phase 1, 7a placebo group
11150493|NCT01877421|EG014|Reported Event|Phase 1, 8a (75mg)|Subjects from phase 1, 8a (75mg) group
11150494|NCT01877421|EG015|Reported Event|Phase 1, 8a Placebo|Subjects from phase 1, 8a placebo group
11150495|NCT01877421|EG016|Reported Event|Phase 1, 9a (100mg)|Subjects from phase 1, 9a (100mg) group
11150496|NCT01877421|EG017|Reported Event|Phase 1, 9a Placebo|Subjects from phase 1, 9a placebo group
11150497|NCT01877421|EG018|Reported Event|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
11150498|NCT01877421|EG019|Reported Event|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
11150499|NCT01877421|EG020|Reported Event|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
11150500|NCT01877421|EG021|Reported Event|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
11150501|NCT01877421|EG022|Reported Event|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
11150502|NCT01877421|EG023|Reported Event|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
11150503|NCT01877421|EG024|Reported Event|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
11150504|NCT01877421|EG025|Reported Event|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
11150505|NCT01877421|EG026|Reported Event|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
11150506|NCT01877421|EG027|Reported Event|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
11150507|NCT01877421|EG028|Reported Event|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
11150508|NCT01877421|EG029|Reported Event|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
11150509|NCT01877421|EG030|Reported Event|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
11150510|NCT01877421|EG031|Reported Event|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
11150511|NCT01877538|BG000|Baseline|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical used with Positron Emission Tomography (PET) imaging. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy control subjects were recruited to this study."
11150512|NCT01877538|FG000|Participant Flow|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy control subjects were scanned in this preliminary pilot study."
11150513|NCT01877538|OG000|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
11150514|NCT01877538|EG000|Reported Event|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy controls were PET scanned in this preliminary study.~No adverse events were detected."
11150515|NCT01877551|BG000|Baseline|Tauroursodeoxycholic Acid|"This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.~Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days."
11150516|NCT01877551|BG001|Baseline|Placebo|"This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.~Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days."
11150517|NCT01877551|BG002|Baseline|Total|Total of all reporting groups
11227545|NCT02383758|EG001|Reported Event|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
11081847|NCT01476644|FG000|Participant Flow|Participants With Moderate Glaucoma|Participants with moderate glaucoma as defined by a disc damage likelihood scale (DDLS range 1 to 9) of the optic nerve between 5 and 8 in at least one eye. One on the DDLS corresponds to healthy optic nerve; 9 is advanced glaucoma damage.
11081848|NCT01476644|OG000|Outcome|Cohort|Moderate glaucoma participants based on a DDLS (disc damage likelihood scale, a grade of the health of the optic nerve) between 5 and 8 in at least one eye. DDLS score ranges from 1 to 10 with 10 being worst optic nerve.
11081849|NCT01476644|OG000|Outcome|Cohort|All participants with moderate glaucoma measured by a DDLS (disc damage likelihood scale) between 5 and 8 in at least one eye agreed to the study.
11081850|NCT01476644|EG000|Reported Event|Cohort|Moderate glaucoma as confirmed by a DDLS (disc damage likelihood scale, optic nerve health) between 5 and 8 in at least one eye. DDLS range 1 to 10 with 10 being worse optic nerve damage.
11081851|NCT01476696|BG000|Baseline|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
11081852|NCT01476696|FG000|Participant Flow|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.~Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
11081853|NCT01476696|FG001|Participant Flow|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel, administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
11081854|NCT01476696|FG002|Participant Flow|Part A Then Part B: Prasugrel Single Dose Then Once-Daily Dose|"Participants who enrolled in Part A and B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition."
11081855|NCT01476696|OG000|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
11081856|NCT01476696|OG000|Outcome|Part A: Prasugrel Single Dose|Part A of the study: 0.03 up to 0.60 milligrams per kilogram (mg/kg) Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses.
11227546|NCT02383862|BG000|Baseline|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
11081857|NCT01476696|OG000|Outcome|Part B: Baseline|Participants in Part B of the study, prior to receiving treatment (Prasugrel once-daily doses).
11081858|NCT01476696|OG001|Outcome|Part B: Prasugrel Once-Daily Dose (0.06 mg/kg)|Participants who received 0.06 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
11081859|NCT01476696|OG002|Outcome|Part B: Prasugrel Once-Daily Dose (0.08 mg/kg)|Participants who received 0.08 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
11081860|NCT01476696|OG003|Outcome|Part B: Prasugrel Once-Daily Dose (0.12 mg/kg)|Participants who received 0.12 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
11081861|NCT01476696|OG000|Outcome|Part B: Prasugrel Once-Daily Dose|Part B: daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study.
11081862|NCT01476696|EG000|Reported Event|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.~Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
11081863|NCT01476696|EG001|Reported Event|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
11081864|NCT01476696|EG002|Reported Event|Part A and Part B Participants: During Part A|"Events reported during Part A for those participants who enrolled in Part A and Part B of study.~Part A: 0.03 mg/kg up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses."
11081865|NCT01476696|EG003|Reported Event|Part A and Part B Participants: During Part B|"Events reported during Part B for those participants who enrolled in Part A and Part B of study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
11081866|NCT01476722|BG000|Baseline|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
11081867|NCT01476722|FG000|Participant Flow|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
11081868|NCT01476722|OG000|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
11081869|NCT01476722|EG000|Reported Event|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
11081870|NCT01476748|BG000|Baseline|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081871|NCT01476748|BG001|Baseline|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081872|NCT01476748|BG002|Baseline|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081873|NCT01476748|BG003|Baseline|Total|Total of all reporting groups
11081874|NCT01476748|FG000|Participant Flow|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081875|NCT01476748|FG001|Participant Flow|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081876|NCT01476748|FG002|Participant Flow|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081877|NCT01476748|OG000|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081878|NCT01476748|OG001|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081879|NCT01476748|OG002|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081880|NCT01476748|EG000|Reported Event|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081881|NCT01476748|EG001|Reported Event|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081882|NCT01476748|EG002|Reported Event|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
11081883|NCT01477320|BG000|Baseline|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
11081884|NCT01477320|BG001|Baseline|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
11081885|NCT01477320|BG002|Baseline|Total|Total of all reporting groups
11081886|NCT01477320|FG000|Participant Flow|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
11081887|NCT01477320|FG001|Participant Flow|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
11081888|NCT01477320|OG000|Outcome|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
11081889|NCT01477320|OG001|Outcome|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
11081890|NCT01477320|EG000|Reported Event|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
11081891|NCT01477320|EG001|Reported Event|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
11081892|NCT01477333|BG000|Baseline|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
11081893|NCT01477333|FG000|Participant Flow|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
11081894|NCT01477333|OG000|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
11081895|NCT01477333|OG000|Outcome|Class II to Class II|UT-15C SR BID
11081896|NCT01477333|OG001|Outcome|Class II to Class III|UT-15C SR BID
11081897|NCT01477333|OG002|Outcome|Class III to Class II|UT-15C SR BID
11081898|NCT01477333|OG003|Outcome|Class III to Class III|UT-15C SR BID
11081899|NCT01477333|EG000|Reported Event|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
11081900|NCT01477450|BG000|Baseline|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081901|NCT01477450|BG001|Baseline|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081902|NCT01477450|BG002|Baseline|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081903|NCT01477450|BG003|Baseline|Total|Total of all reporting groups
11081904|NCT01477450|FG000|Participant Flow|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081905|NCT01477450|FG001|Participant Flow|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081906|NCT01477450|FG002|Participant Flow|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081907|NCT01477450|OG000|Outcome|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081908|NCT01477450|OG001|Outcome|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081909|NCT01477450|OG002|Outcome|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081910|NCT01477450|EG000|Reported Event|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081911|NCT01477450|EG001|Reported Event|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081912|NCT01477450|EG002|Reported Event|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
11081913|NCT01477463|BG000|Baseline|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
11081914|NCT01477463|BG001|Baseline|Arm B: Placebo|Placebo - subjects may cross over to vitamin D treatment after placebo treatment is complete
11081915|NCT01477463|BG002|Baseline|Total|Total of all reporting groups
11081916|NCT01477463|FG000|Participant Flow|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
11081917|NCT01477463|FG001|Participant Flow|Arm B: Placebo|Placebo - patients may cross over to vitamin D3 treatment after placebo treatment
11081918|NCT01477463|OG000|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
11081919|NCT01477463|OG000|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
11081920|NCT01477463|OG001|Outcome|Arm B: Placebo|Placebo (inactive capsule)
11081921|NCT01477463|OG001|Outcome|Arm B: Placebo|Placebo - inactive capsule
11081922|NCT01477463|EG000|Reported Event|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
11081923|NCT01477463|EG001|Reported Event|Arm B: Placebo|Placebo (inactive capsule)
11081924|NCT01477567|BG000|Baseline|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081925|NCT01477567|BG001|Baseline|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081926|NCT01477567|BG002|Baseline|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081927|NCT01477567|BG003|Baseline|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081928|NCT01477567|BG004|Baseline|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081929|NCT01477567|BG005|Baseline|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081930|NCT01477567|BG006|Baseline|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
11081931|NCT01477567|BG007|Baseline|Total|Total of all reporting groups
11081932|NCT01477567|FG000|Participant Flow|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11227547|NCT02383862|BG001|Baseline|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
11227548|NCT02383862|BG002|Baseline|Total|Total of all reporting groups
11081933|NCT01477567|FG001|Participant Flow|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081934|NCT01477567|FG002|Participant Flow|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081935|NCT01477567|FG003|Participant Flow|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081936|NCT01477567|FG004|Participant Flow|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081937|NCT01477567|FG005|Participant Flow|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081938|NCT01477567|FG006|Participant Flow|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
11081939|NCT01477567|OG000|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081940|NCT01477567|OG001|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081941|NCT01477567|OG002|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081942|NCT01477567|OG003|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081943|NCT01477567|OG004|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081944|NCT01477567|OG005|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081945|NCT01477567|OG006|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
11081946|NCT01477567|OG000|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081947|NCT01477567|OG001|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081948|NCT01477567|OG002|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081949|NCT01477567|OG003|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081950|NCT01477567|OG004|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
11081951|NCT01477567|EG000|Reported Event|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081952|NCT01477567|EG001|Reported Event|1 mg LY3009385|LY3009385: 1 milligram (mg), subcutaneous (SC) injection, single dose on Day 1
11081953|NCT01477567|EG002|Reported Event|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081954|NCT01477567|EG003|Reported Event|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081955|NCT01477567|EG004|Reported Event|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081956|NCT01477567|EG005|Reported Event|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
11081957|NCT01477567|EG006|Reported Event|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
11081958|NCT01477710|BG000|Baseline|All Participants|Each clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Then, each will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, each will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
11081959|NCT01477710|FG000|Participant Flow|All Participants|Each participant will perform 3 tasks -- in the same order. First, the clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Next, the clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, the clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
11081960|NCT01477710|OG000|Outcome|Hold Mask|Mask is held in place by caregiver.
11081961|NCT01477710|OG001|Outcome|Strap Mask|Mask is strapped to model using a securing device
11081962|NCT01477710|OG002|Outcome|Airway|Using a supraglottic airway
11227549|NCT02383862|FG000|Participant Flow|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
11081963|NCT01477710|EG000|Reported Event|Hold Mask|
11081964|NCT01477710|EG001|Reported Event|Strap Mask|
11081965|NCT01477710|EG002|Reported Event|Airway|
11081966|NCT01477749|BG000|Baseline|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
11081967|NCT01477749|FG000|Participant Flow|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
11081968|NCT01477749|OG000|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
11081969|NCT01477749|EG000|Reported Event|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
11081970|NCT01477762|BG000|Baseline|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
11081971|NCT01477762|BG001|Baseline|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
11081972|NCT01477762|BG002|Baseline|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
11081973|NCT01477762|BG003|Baseline|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
11081974|NCT01477762|BG004|Baseline|Total|Total of all reporting groups
11081975|NCT01477762|FG000|Participant Flow|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
11081976|NCT01477762|FG001|Participant Flow|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
11081977|NCT01477762|FG002|Participant Flow|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
11081978|NCT01477762|FG003|Participant Flow|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
11081979|NCT01477762|OG000|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
11081980|NCT01477762|OG001|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
11081981|NCT01477762|OG002|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
11081982|NCT01477762|OG003|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
11081983|NCT01477762|EG000|Reported Event|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
11081984|NCT01477762|EG001|Reported Event|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
11081985|NCT01477762|EG002|Reported Event|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
11081986|NCT01477762|EG003|Reported Event|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
11081987|NCT01477853|BG000|Baseline|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
11081988|NCT01477853|BG001|Baseline|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
11081989|NCT01477853|BG002|Baseline|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
11081990|NCT01477853|BG003|Baseline|Total|Total of all reporting groups
11081991|NCT01477853|FG000|Participant Flow|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
11081992|NCT01477853|FG001|Participant Flow|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
11081993|NCT01477853|FG002|Participant Flow|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
11227550|NCT02383862|FG001|Participant Flow|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
11081994|NCT01477853|OG000|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
11081995|NCT01477853|OG001|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
11081996|NCT01477853|OG002|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
11081997|NCT01477853|EG000|Reported Event|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
11081998|NCT01477853|EG001|Reported Event|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
11081999|NCT01477853|EG002|Reported Event|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
11082000|NCT01477892|BG000|Baseline|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
11082001|NCT01477892|BG001|Baseline|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
11082002|NCT01477892|BG002|Baseline|Total|Total of all reporting groups
11082003|NCT01477892|FG000|Participant Flow|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
11227551|NCT02383862|OG000|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
11227552|NCT02383862|OG001|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
11082004|NCT01477892|FG001|Participant Flow|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
11082005|NCT01477892|OG000|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
11082006|NCT01477892|OG001|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
11082007|NCT01477892|EG000|Reported Event|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
11082008|NCT01477892|EG001|Reported Event|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
11082009|NCT01478009|BG000|Baseline|KRG Extract|
11082010|NCT01478009|BG001|Baseline|Placebo|
11082011|NCT01478009|BG002|Baseline|Total|Total of all reporting groups
11082012|NCT01478009|FG000|Participant Flow|KRG(Korean Red Ginseng) Extract|"KRG Extract(3times/day, 9capsules/day, 3g/day) for 12weeks~KRG Extract : KRG Extract was extracted at high temperatures (above 95℃)"
11082013|NCT01478009|FG001|Participant Flow|Placebo|"Placebo(3times/day, 9capsules/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with KRG Extract."
11082014|NCT01478009|OG000|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
11082015|NCT01478009|OG001|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
11082016|NCT01478009|EG000|Reported Event|KRG Extract|
11082017|NCT01478009|EG001|Reported Event|Placebo|
11082018|NCT01478048|BG000|Baseline|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
11082019|NCT01478048|BG001|Baseline|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
11082020|NCT01478048|BG002|Baseline|Total|Total of all reporting groups
11082021|NCT01478048|FG000|Participant Flow|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
11082022|NCT01478048|FG001|Participant Flow|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
11082023|NCT01478048|OG000|Outcome|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
11082024|NCT01478048|OG001|Outcome|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
11091991|NCT01537029|BG000|Baseline|Doxorubicin and Cyclophosphamide|"Doxorubicin: Dosed by the patient's treating physician according to local standard of care.~Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care"
11091992|NCT01537029|FG000|Participant Flow|Doxorubicin and Cyclophosphamide|"Doxorubicin: Dosed by the patient's treating physician according to local standard of care.~Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care"
11082025|NCT01478048|EG000|Reported Event|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
11082026|NCT01478048|EG001|Reported Event|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
11082027|NCT01478087|BG000|Baseline|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
11082028|NCT01478087|FG000|Participant Flow|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
11082029|NCT01478087|OG000|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
11227553|NCT02383862|OG000|Outcome|Follow up Sample Responding to PIRS-2 (N=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on the PIRS-2. No group comparisons were made.
11227554|NCT02383862|OG000|Outcome|Follow up Sample Responding to PEG (n=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on PEG. No group comparisons were made.
11227555|NCT02383862|OG000|Outcome|Follow up Sample Responding to GAD-2 (n=256)|Of the 300 participants invited to complete the 3-month follow up assessment, 256 participants responded to items on the GAD-2. No group comparisons were made.
11227556|NCT02383862|OG000|Outcome|Follow up Sample Responding to PHQ-2 (n=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on the PHQ-2. No group comparisons were made.
11227557|NCT02383862|OG000|Outcome|Follow up Sample Responding to SF-36 Vitality Scale (n=256)|Of the 300 participants invited to complete the 3-month follow up assessment, 256 participants responded to items on the SF-36 vitality scale. No group comparisons were made.
11227558|NCT02383862|OG000|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
11227559|NCT02383862|OG001|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
11227560|NCT02383862|EG000|Reported Event|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
11227561|NCT02383862|EG001|Reported Event|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
11227562|NCT02383940|BG000|Baseline|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.
11082030|NCT01478087|EG000|Reported Event|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
11227563|NCT02383940|BG001|Baseline|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
11227564|NCT02383940|BG002|Baseline|Total|Total of all reporting groups
11227565|NCT02383940|FG000|Participant Flow|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.
11082031|NCT01478256|BG000|Baseline|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
11082032|NCT01478256|BG001|Baseline|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
11082033|NCT01478256|BG002|Baseline|Total|Total of all reporting groups
11082034|NCT01478256|FG000|Participant Flow|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
11227566|NCT02383940|FG001|Participant Flow|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
11227567|NCT02383940|OG000|Outcome|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.
11227568|NCT02383940|OG001|Outcome|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
11227569|NCT02383940|EG000|Reported Event|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.
11227570|NCT02383940|EG001|Reported Event|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
11227571|NCT02384044|BG000|Baseline|Crest® Sensi-Stop™ Strips|"Professionally Applied~Crest® Sensi-Stop™ Strips"
11227572|NCT02384044|BG001|Baseline|Colgate® Sensitivity Relief Pen|"Professionally Applied~Colgate® Sensitivity Relief Pen"
11227573|NCT02384044|BG002|Baseline|Total|Total of all reporting groups
11227574|NCT02384044|FG000|Participant Flow|Crest® Sensi-Stop™ Strips|"Professionally Applied~Crest® Sensi-Stop™ Strips"
11227575|NCT02384044|FG001|Participant Flow|Colgate® Sensitivity Relief Pen|"Professionally Applied~Colgate® Sensitivity Relief Pen"
11227576|NCT02384044|OG000|Outcome|Crest® Sensi-Stop™ Strips|"Professionally Applied~Crest® Sensi-Stop™ Strips"
11227577|NCT02384044|OG001|Outcome|Colgate® Sensitivity Relief Pen|"Professionally Applied~Colgate® Sensitivity Relief Pen"
11082035|NCT01478256|FG001|Participant Flow|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
11082036|NCT01478256|OG000|Outcome|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
11082037|NCT01478256|OG001|Outcome|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
11082038|NCT01478256|OG000|Outcome|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
11082039|NCT01478256|OG001|Outcome|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
11082040|NCT01478256|EG000|Reported Event|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
11082041|NCT01478256|EG001|Reported Event|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
11082042|NCT01478321|BG000|Baseline|Treatment (Radiation, Chemotherapy, Monoclonal Antibody)|"CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.~ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~Temozolomide: Given PO~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Bevacizumab: Given IV~Questionnaire administration: Ancillary studies"
11082043|NCT01478321|FG000|Participant Flow|Treatment (Radiation, Chemotherapy, Monoclonal Antibody)|"CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.~ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~Temozolomide: Given PO~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Bevacizumab: Given IV~Questionnaire administration: Ancillary studies"
11082044|NCT01478321|OG000|Outcome|Treatment (Radiation, Chemotherapy, Monoclonal Antibody)|"CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.~ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~Temozolomide: Given PO~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Bevacizumab: Given IV~Questionnaire administration: Ancillary studies"
11082045|NCT01478321|EG000|Reported Event|Treatment (Radiation, Chemotherapy, Monoclonal Antibody)|"CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.~ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~Temozolomide: Given PO~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Bevacizumab: Given IV~Questionnaire administration: Ancillary studies"
11082046|NCT01478347|BG000|Baseline|rMenB+OMV NZ|"Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study.~In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data."
11082047|NCT01478347|FG000|Participant Flow|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
11082048|NCT01478347|OG000|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
11082049|NCT01478347|EG000|Reported Event|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
11082050|NCT01478360|BG000|Baseline|AIN457|AIN457 10 mg/kg
11082051|NCT01478360|BG001|Baseline|Placebo|Placebo intravenous injection
11082052|NCT01478360|BG002|Baseline|Total|Total of all reporting groups
11227578|NCT02384044|EG000|Reported Event|Crest® Sensi-Stop™ Strips|"Professionally Applied~Crest® Sensi-Stop™ Strips"
11082053|NCT01478360|FG000|Participant Flow|AIN457|AIN457 10 mg/kg
11082054|NCT01478360|FG001|Participant Flow|Placebo|Placebo intravenous injection
11082055|NCT01478360|OG000|Outcome|AIN457|AIN457 10 mg/kg
11082056|NCT01478360|OG001|Outcome|Placebo|Placebo intravenous injection
11082057|NCT01478360|EG000|Reported Event|AIN457 10 mg/kg|AIN457 10 mg/kg
11082058|NCT01478360|EG001|Reported Event|Placebo|Placebo
11082059|NCT01478373|BG000|Baseline|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
11082060|NCT01478373|FG000|Participant Flow|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
11082061|NCT01478373|OG000|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
11082062|NCT01478373|EG000|Reported Event|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
11082063|NCT01478581|BG000|Baseline|Cohort 1|"PCI-32765 420 mg per day~PCI-32765"
11082064|NCT01478581|BG001|Baseline|Cohort 2|"PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082065|NCT01478581|BG002|Baseline|Cohort 3|"PCI-32765 840 mg per day~PCI-32765"
11082066|NCT01478581|BG003|Baseline|Cohort 4|"PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082067|NCT01478581|BG004|Baseline|Total|Total of all reporting groups
11082068|NCT01478581|FG000|Participant Flow|PCI-32765 420 mg Per Day|"PCI-32765 420 mg per day~PCI-32765"
11082069|NCT01478581|FG001|Participant Flow|PCI-32765 560 mg Per Day, 40 mg Dexamethasone|"PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082070|NCT01478581|FG002|Participant Flow|PCI-32765 840 mg Per Day|"PCI-32765 840 mg per day~PCI-32765"
11082071|NCT01478581|FG003|Participant Flow|PCI-32765 840 mg Per Day, 40 mg Dexamethasone|"PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082072|NCT01478581|OG000|Outcome|Cohort 1|"PCI-32765 420 mg per day~PCI-32765"
11082073|NCT01478581|OG001|Outcome|Cohort 2|"PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082074|NCT01478581|OG002|Outcome|Cohort 3|"PCI-32765 840 mg per day~PCI-32765"
11082075|NCT01478581|OG003|Outcome|Cohort 4|"PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082076|NCT01478581|OG000|Outcome|PCI-32765 420 mg Per Day|"PCI-32765 420 mg per day~PCI-32765"
11082077|NCT01478581|OG001|Outcome|PCI-32765 560 mg Per Day, 40 mg Dexamethasone|"PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082078|NCT01478581|OG002|Outcome|PCI-32765 840 mg Per Day|"PCI-32765 840 mg per day~PCI-32765"
11082079|NCT01478581|OG003|Outcome|PCI-32765 840 mg Per Day, 40 mg Dexamethasone|"PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082080|NCT01478581|EG000|Reported Event|Cohort 1|"PCI-32765 420 mg per day~PCI-32765"
11082081|NCT01478581|EG001|Reported Event|Cohort 2|"PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082082|NCT01478581|EG002|Reported Event|Cohort 3|"PCI-32765 840 mg per day~PCI-32765"
11082083|NCT01478581|EG003|Reported Event|Cohort 4|"PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week~PCI-32765~Dexamethasone"
11082084|NCT01478594|BG000|Baseline|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082085|NCT01478594|BG001|Baseline|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082086|NCT01478594|BG002|Baseline|Total|Total of all reporting groups
11082087|NCT01478594|FG000|Participant Flow|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each 28-day cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy consisting of oxaliplatin, 85 mg/m^2, leucovorin 400 mg/m^2, and 5-fluorouracil 400 mg/m^2 bolus then 2400 mg/m^2 every 2 weeks on Days 1 and 15 of each cycle.
11082088|NCT01478594|FG001|Participant Flow|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082089|NCT01478594|OG000|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082090|NCT01478594|OG001|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082091|NCT01478594|OG000|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082092|NCT01478594|OG000|Outcome|Tivozanib: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082093|NCT01478594|OG001|Outcome|Tivozanib: LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082094|NCT01478594|OG002|Outcome|Bevacizumab: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082095|NCT01478594|OG003|Outcome|Bevacizumab : LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082096|NCT01478594|OG000|Outcome|Tivozanib: VEGF-A < Median|Participants with VEGF-A levels < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082097|NCT01478594|OG001|Outcome|Tivozanib: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082098|NCT01478594|OG002|Outcome|Bevacizumab: VEGF-A < Median|Participants with VEGF-A levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082099|NCT01478594|OG003|Outcome|Bevacizumab: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082100|NCT01478594|OG000|Outcome|Tivozanib: VEGF-C < Median|Participants with VEGF-C levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082101|NCT01478594|OG001|Outcome|Tivozanib: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082102|NCT01478594|OG002|Outcome|Bevacizumab: VEGF-C < Median|Participants with VEGF-C levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082103|NCT01478594|OG003|Outcome|Bevacizumab: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082104|NCT01478594|OG000|Outcome|Tivozanib: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082105|NCT01478594|OG001|Outcome|Tivozanib: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082106|NCT01478594|OG002|Outcome|Bevacizumab: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082107|NCT01478594|OG003|Outcome|Bevacizumab: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082108|NCT01478594|OG000|Outcome|Tivozanib: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082109|NCT01478594|OG001|Outcome|Tivozanib: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082110|NCT01478594|OG002|Outcome|Bevacizumab: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082111|NCT01478594|OG003|Outcome|Bevacizumab: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082112|NCT01478594|OG000|Outcome|Tivozanib: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082113|NCT01478594|OG001|Outcome|Tivozanib: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082114|NCT01478594|OG002|Outcome|Bevacizumab: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082115|NCT01478594|OG003|Outcome|Bevacizumab: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082116|NCT01478594|OG000|Outcome|Tivozanib: IL-8 < Median|Participants with IL-8 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082117|NCT01478594|OG001|Outcome|Tivozanib: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082118|NCT01478594|OG002|Outcome|Bevacizumab: IL-8 < Median|Participants with IL-8 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11091993|NCT01537029|OG000|Outcome|Doxorubicin and Cyclophosphamide|"Doxorubicin: Dosed by the patient's treating physician according to local standard of care.~Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care"
11082119|NCT01478594|OG003|Outcome|Bevacizumab: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082120|NCT01478594|OG000|Outcome|Tivozanib: Neuropilin < Median|Participants with neuropilin levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082121|NCT01478594|OG001|Outcome|Tivozanib: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082122|NCT01478594|OG002|Outcome|Bevacizumab: Neuropilin < Median|Participants with neuropilin levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and FOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082123|NCT01478594|OG003|Outcome|Bevacizumab: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082124|NCT01478594|OG000|Outcome|Tivozanib: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082125|NCT01478594|OG001|Outcome|Tivozanib: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082126|NCT01478594|OG002|Outcome|Bevacizumab: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082127|NCT01478594|OG003|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082128|NCT01478594|OG000|Outcome|Tivozanib: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082129|NCT01478594|OG001|Outcome|Tivozanib: VEGF-C RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082130|NCT01478594|OG002|Outcome|Bevacizumab: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082131|NCT01478594|OG003|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082132|NCT01478594|OG000|Outcome|Tivozanib: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082133|NCT01478594|OG001|Outcome|Tivozanib: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082134|NCT01478594|OG002|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082135|NCT01478594|OG003|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082136|NCT01478594|OG000|Outcome|Tivozanib: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082137|NCT01478594|OG001|Outcome|Tivozanib: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082138|NCT01478594|OG002|Outcome|Bevacizumab: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082139|NCT01478594|OG003|Outcome|Bevacizumab: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082140|NCT01478594|OG000|Outcome|Tivozanib: PIGF RNA < Median|Participants with PIGF RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11227579|NCT02384044|EG001|Reported Event|Colgate® Sensitivity Relief Pen|"Professionally Applied~Colgate® Sensitivity Relief Pen"
11082141|NCT01478594|OG001|Outcome|Tivozanib: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082142|NCT01478594|OG002|Outcome|Bevacizumab: PIGF RNA < Median|Participants with PIGF RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082143|NCT01478594|OG003|Outcome|Bevacizumab: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082144|NCT01478594|EG000|Reported Event|Tivozanib + mFOLFOX6|Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082145|NCT01478594|EG001|Reported Event|Bevacizumab + mFOLFOX6|Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
11082146|NCT01478620|BG000|Baseline|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
11082147|NCT01478620|FG000|Participant Flow|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
11082148|NCT01478620|OG000|Outcome|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
11082149|NCT01478620|EG000|Reported Event|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
11082150|NCT01478828|BG000|Baseline|Lovastatin|"After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.~Lovastatin: oral qd varying dose escalations/de-escalations"
11082151|NCT01478828|FG000|Participant Flow|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
11082152|NCT01478828|OG000|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
11082153|NCT01478828|OG000|Outcome|Lovastatin|"After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.~Lovastatin: oral qd varying dose escalations/de-escalations"
11082154|NCT01478828|EG000|Reported Event|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
11082155|NCT01478854|BG000|Baseline|Neural Progeniter Cell Sparing Radiation With Temozolomide|"All subjects are treated with neural progenitor cell sparing radiation to 60 Gy in 2 Gy per day, 30 fractions Concurrent and adjuvant temozolomide chemotherapy~Radiation: Patients will be treated to a total dose of 60 Gy with a once daily fractionation schedule of 2 Gy per fraction, administered five days per week. All patients will undergo CT simulation with intravenous contrast. In addition they will undergo MRI simulation with both T1 with gadolinium as well as FLAIR sequences. They will be treated in a supine position using an aquaplast mask system for immobilization. CT image data will be reconstructed in approximately 3 mm slice thickness and manually coregistered with T1 post-gadolinium and FLAIR sequence MRI.~Chemotherapy: Temozolomide"
11082156|NCT01478854|FG000|Participant Flow|Neural Progeniter Cell Sparing Radiation With Temozolomide|"All subjects are treated with neural progenitor cell sparing radiation to 60 Gy in 2 Gy per day, 30 fractions Concurrent and adjuvant temozolomide chemotherapy~Radiation: Patients will be treated to a total dose of 60 Gy with a once daily fractionation schedule of 2 Gy per fraction, administered five days per week. All patients will undergo CT simulation with intravenous contrast. In addition they will undergo MRI simulation with both T1 with gadolinium as well as FLAIR sequences. They will be treated in a supine position using an aquaplast mask system for immobilization. CT image data will be reconstructed in approximately 3 mm slice thickness and manually coregistered with T1 post-gadolinium and FLAIR sequence MRI.~Chemotherapy: Temozolomide"
11082157|NCT01478854|OG000|Outcome|Neural Progeniter Cell Sparing Radiation With Temozolomide|"All subjects are treated with neural progenitor cell sparing radiation to 60 Gy in 2 Gy per day, 30 fractions Concurrent and adjuvant temozolomide chemotherapy~Radiation: Patients will be treated to a total dose of 60 Gy with a once daily fractionation schedule of 2 Gy per fraction, administered five days per week. All patients will undergo CT simulation with intravenous contrast. In addition they will undergo MRI simulation with both T1 with gadolinium as well as FLAIR sequences. They will be treated in a supine position using an aquaplast mask system for immobilization. CT image data will be reconstructed in approximately 3 mm slice thickness and manually coregistered with T1 post-gadolinium and FLAIR sequence MRI.~Chemotherapy: Temozolomide"
11091994|NCT01537029|EG000|Reported Event|Doxorubicin and Cyclophosphamide|"Doxorubicin: Dosed by the patient's treating physician according to local standard of care.~Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care"
11233758|NCT02431052|OG004|Outcome|Olumacostat Glasaretil Gel, 7.5% BID|"Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks~Vehicle"
11082158|NCT01478854|EG000|Reported Event|Neural Progeniter Cell Sparing Radiation With Temozolomide|"All subjects are treated with neural progenitor cell sparing radiation to 60 Gy in 2 Gy per day, 30 fractions Concurrent and adjuvant temozolomide chemotherapy~Radiation: Patients will be treated to a total dose of 60 Gy with a once daily fractionation schedule of 2 Gy per fraction, administered five days per week. All patients will undergo CT simulation with intravenous contrast. In addition they will undergo MRI simulation with both T1 with gadolinium as well as FLAIR sequences. They will be treated in a supine position using an aquaplast mask system for immobilization. CT image data will be reconstructed in approximately 3 mm slice thickness and manually coregistered with T1 post-gadolinium and FLAIR sequence MRI.~Chemotherapy: Temozolomide"
11082159|NCT01478958|BG000|Baseline|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
11082160|NCT01478958|BG001|Baseline|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
11082161|NCT01478958|BG002|Baseline|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
11082162|NCT01478958|BG003|Baseline|Total|Total of all reporting groups
11082163|NCT01478958|FG000|Participant Flow|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
11082164|NCT01478958|FG001|Participant Flow|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
11082165|NCT01478958|FG002|Participant Flow|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
11082166|NCT01478958|OG000|Outcome|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
11082167|NCT01478958|OG001|Outcome|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
11082168|NCT01478958|OG002|Outcome|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
11082169|NCT01478958|EG000|Reported Event|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
11082170|NCT01478958|EG001|Reported Event|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
11082171|NCT01478958|EG002|Reported Event|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
11082172|NCT01478971|BG000|Baseline|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
11227580|NCT02384070|BG000|Baseline|Group 1: Upstream Aspirin + Clopidrogel|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
11082173|NCT01478971|FG000|Participant Flow|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
11082174|NCT01478971|OG000|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
11082175|NCT01478971|OG000|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
11082176|NCT01478971|OG001|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
11082177|NCT01478971|EG000|Reported Event|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
11233759|NCT02431052|OG000|Outcome|Olumacostat Glasaretil Gel, Vehicle QD|Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
11082178|NCT01478971|EG001|Reported Event|ESA Free Week|A one-week erythropoiesis-stimulating agent (ESA)-free period following 6 months of standard of care.
11082179|NCT01478971|EG002|Reported Event|Peginesatide Treatment Period|In the second six months of the study participants transitioned to once monthly peginesatide injection (the Peginesatide Treatment Period [PTP]).
11082180|NCT01479127|BG000|Baseline|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
11082181|NCT01479127|FG000|Participant Flow|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-Parkinson's disease (PD) medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel [LCIG]), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
11082182|NCT01479127|OG000|Outcome|Oral Levodopa/Carbidopa Tablet|During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)
11233760|NCT02431052|OG001|Outcome|Olumacostat Glasaretil Gel, Vehicle BID|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11082183|NCT01479127|OG000|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
11082184|NCT01479127|OG000|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
11082185|NCT01479127|OG001|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
11082186|NCT01479127|EG000|Reported Event|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
11082187|NCT01479127|EG001|Reported Event|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
11082188|NCT01479270|BG000|Baseline|Tap Block|Patients randomized to either Tap Block or No Tap Block
11082189|NCT01479270|BG001|Baseline|No Block|Patients randomized to either Tap Block or No Tap Block
11082190|NCT01479270|BG002|Baseline|Total|Total of all reporting groups
11227581|NCT02384070|BG001|Baseline|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
11082191|NCT01479270|FG000|Participant Flow|Tap Block|Patients undergoing Total Laparoscopic Hysterectomy were randomized with the Tap Block
11227582|NCT02384070|BG002|Baseline|Group 3: Upstream Aspirin Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
11227583|NCT02384070|BG003|Baseline|Total|Total of all reporting groups
11082192|NCT01479270|FG001|Participant Flow|No Block|Patients undergoing Total Laparoscopic Hysterectomy were randomized without Tap Block
11082193|NCT01479270|OG000|Outcome|TAP Block|"20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.~TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine: Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia"
11082194|NCT01479270|OG001|Outcome|No Block|Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
11082195|NCT01479270|OG000|Outcome|Tap Block|Patients undergoing Total Laparoscopic Hysterectomy were randomized to either the Tap Block or Nothing
11082196|NCT01479270|OG001|Outcome|No Block|Patients undergoing Total Laparoscopic Hysterectomy were randomized to either the Tap Block or Nothing
11082197|NCT01479270|OG000|Outcome|TAP Block|Patients undergoing Total Laparoscopic Hysterectomy were randomized to either the Tap Block or Nothing
11082198|NCT01479270|EG000|Reported Event|TAP Block|Patients undergoing Total Laparoscopic Hysterectomy were randomized to either the Tap Block or Nothing
11082199|NCT01479270|EG001|Reported Event|No Block|Patients undergoing Total Laparoscopic Hysterectomy were randomized to either the Tap Block or Nothing
11082200|NCT01479348|BG000|Baseline|1/Intravenous (IV) Tetrahydrouridine (THU)|"[F-18]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine~[F-18]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer~Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m^2, IV~Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral~Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET"
11082201|NCT01479348|FG000|Participant Flow|1/Intravenous (IV) Tetrahydrouridine (THU)|"[F-18]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine~[F-18]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer~Tetrahydrouridine intravenous (IV): Total dose of THU = 350 mg/m^2, IV~Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral~Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET"
11082202|NCT01479348|FG001|Participant Flow|2/Oral Tetrahydrouridine (THU)|"[F-18]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine~[F-18]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer~Tetrahydrouridine intravenous (IV): Total dose of THU = 350 mg/m^2, IV~Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral~Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET"
11082203|NCT01479348|OG000|Outcome|1/Intravenous (IV) Tetrahydrouridine (THU)|"[F-18]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine~[F-18]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer~Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m^2, IV~Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral~Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET"
11227584|NCT02384070|FG000|Participant Flow|Group 1: Upstream Aspirin + Clopidrogel|Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator
11082204|NCT01479348|EG000|Reported Event|1/Intravenous (IV) Tetrahydrouridine (THU)|"[F-18]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine~[F-18]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer~Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m^2, IV~Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral~Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET"
11082205|NCT01479374|BG000|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
11082206|NCT01479374|BG001|Baseline|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
11082207|NCT01479374|BG002|Baseline|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
11082208|NCT01479374|BG003|Baseline|Total|Total of all reporting groups
11082209|NCT01479374|FG000|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
11082210|NCT01479374|FG001|Participant Flow|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
11082211|NCT01479374|FG002|Participant Flow|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
11082212|NCT01479374|OG000|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
11082213|NCT01479374|OG001|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
11082214|NCT01479374|OG002|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
11082215|NCT01479374|EG000|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
11082216|NCT01479374|EG001|Reported Event|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
11082217|NCT01479374|EG002|Reported Event|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
11082218|NCT01479426|BG000|Baseline|EFLA400(960mg)|
11082219|NCT01479426|BG001|Baseline|Placebo(960mg)|
11227585|NCT02384070|FG001|Participant Flow|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
11227586|NCT02384070|FG002|Participant Flow|Group 3: Upstream Aspirin Plus Bivalirudin|Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
11082220|NCT01479426|BG002|Baseline|Total|Total of all reporting groups
11082221|NCT01479426|FG000|Participant Flow|EFLA400|"EFLA400(2times/day, 2capsules/day, 960mg/day) for 12weeks~EFLA400: Red Ginseng (90%) and Crataegus pinnatifida Bunge (10%) to high temperature (110 ~ 120 ˚ C) were reacted in the ginsenoside Rg3 increased by alcohol extraction after manufacture."
11082222|NCT01479426|FG001|Participant Flow|Placebo|"Placebo(2times/day, 2capsules/day, 960mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with EFLA400"
11082223|NCT01479426|OG000|Outcome|EFLA400|Oral intake EFLA400(960mg/day) for 12weeks.
11082224|NCT01479426|OG001|Outcome|Placebo|Oral intake placebo(960mg/day) for 12weeks.
11082225|NCT01479426|EG000|Reported Event|EFLA400(960mg)|
11082226|NCT01479426|EG001|Reported Event|Placebo(960mg)|
11082227|NCT01479439|BG000|Baseline|Losartan - No Albuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) <30 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082228|NCT01479439|BG001|Baseline|Losartan - Microalbuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) 30-300 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082229|NCT01479439|BG002|Baseline|Losartan - Macroalbuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) >300 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082230|NCT01479439|BG003|Baseline|Total|Total of all reporting groups
11082231|NCT01479439|FG000|Participant Flow|Losartan - No Albuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) <30 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082232|NCT01479439|FG001|Participant Flow|Losartan - Microalbuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) 30-300 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082233|NCT01479439|FG002|Participant Flow|Losartan - Macroalbuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) >300 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082234|NCT01479439|OG000|Outcome|Losartan - No Albuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) <30 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082235|NCT01479439|OG001|Outcome|Losartan - Microalbuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) 30-300 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082236|NCT01479439|OG002|Outcome|Losartan - Macroalbuminuria|"Baseline urinary albumin-to-creatinine ratio (UACR) >300 mg/g.~All participants in this study in all arms were treated with losartan using the same dosing regimen. Study arms are only differentiated by baseline UACR."
11082237|NCT01479439|OG000|Outcome|No Albuminuria (NoA)|Baseline urinary albumin-to-creatinine ratio (UACR) <30 mg/g
11082238|NCT01479439|OG001|Outcome|Microalbuminuria (MicroA)|Baseline urinary albumin-to-creatinine ratio (UACR) 30-300 mg/g
11227587|NCT02384070|OG000|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
11227588|NCT02384070|OG001|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
11082239|NCT01479439|OG002|Outcome|Macroalbuminuria|Baseline urinary albumin-to-creatinine ratio (UACR) >300 mg/g
11082240|NCT01479439|EG000|Reported Event|No Albuminuria (NoA)|Baseline urinary albumin-to-creatinine ratio (UACR) <30 mg/g
11082241|NCT01479439|EG001|Reported Event|Microalbuminuria (MicroA)|Baseline urinary albumin-to-creatinine ratio (UACR) 30-300 mg/g
11082242|NCT01479439|EG002|Reported Event|Macroalbuminuria|Baseline urinary albumin-to-creatinine ratio (UACR) >300 mg/g
11082243|NCT01479465|BG000|Baseline|FOLFIRI + SIM 700 mg (Part A)|Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
11082244|NCT01479465|BG001|Baseline|FOLFIRI + Placebo (Part B)|Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
11082245|NCT01479465|BG002|Baseline|FOLFIRI + SIM 200 mg (Part B)|Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
11082246|NCT01479465|BG003|Baseline|FOLFIRI + SIM 700 mg (Part B)|Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
11082247|NCT01479465|BG004|Baseline|Total|Total of all reporting groups
11082248|NCT01479465|FG000|Participant Flow|FOLFIRI + SIM 700 mg (Part A)|Participants received simtuzumab (SIM) 700 mg via intravenous infusion followed by leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI; l-leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours and irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes, followed by fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours) on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
11227589|NCT02384070|OG002|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
11082249|NCT01479465|FG001|Participant Flow|FOLFIRI + Placebo (Part B)|Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
11082250|NCT01479465|FG002|Participant Flow|FOLFIRI + SIM 200 mg (Part B)|Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
11082251|NCT01479465|FG003|Participant Flow|FOLFIRI + SIM 700 mg (Part B)|Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
11082252|NCT01479465|OG000|Outcome|FOLFIRI + SIM 700 mg (Part A)|Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
11082253|NCT01479465|OG001|Outcome|FOLFIRI + Placebo (Part B)|Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
11082254|NCT01479465|OG002|Outcome|FOLFIRI + SIM 200 mg (Part B)|Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
11082255|NCT01479465|OG003|Outcome|FOLFIRI + SIM 700 mg (Part B)|Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
11082256|NCT01479465|EG000|Reported Event|FOLFIRI + SIM 700 mg (Part A)|Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
11082257|NCT01479465|EG001|Reported Event|FOLFIRI + Placebo (Part B)|Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
11082258|NCT01479465|EG002|Reported Event|FOLFIRI + SIM 200 mg (Part B)|Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
11082259|NCT01479465|EG003|Reported Event|FOLFIRI + SIM 700 mg (Part B)|Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
11082260|NCT01479478|BG000|Baseline|Probiotic Dietary Supplement|"Probiotic dietary supplement one capsule once per day until delivery.~Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14"
11082261|NCT01479478|BG001|Baseline|Placebo|"Placebo capsule, one daily until delivery.~Placebo: One placebo capsule daily."
11082262|NCT01479478|BG002|Baseline|Total|Total of all reporting groups
11082263|NCT01479478|FG000|Participant Flow|Probiotic Dietary Supplement|"Probiotic dietary supplement one capsule once per day until delivery.~Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14"
11082264|NCT01479478|FG001|Participant Flow|Placebo|"Placebo capsule, one daily until delivery.~Placebo: One placebo capsule daily."
11082265|NCT01479478|OG000|Outcome|Probiotic Dietary Supplement|"Probiotic dietary supplement one capsule once per day until delivery.~Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14"
11082266|NCT01479478|OG001|Outcome|Placebo|"Placebo capsule, one daily until delivery.~Placebo: One placebo capsule daily."
11082267|NCT01479478|EG000|Reported Event|Probiotic Dietary Supplement|"Probiotic dietary supplement one capsule once per day until delivery.~Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14"
11082268|NCT01479478|EG001|Reported Event|Placebo|"Placebo capsule, one daily until delivery.~Placebo: One placebo capsule daily."
11082269|NCT01479517|BG000|Baseline|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
11082270|NCT01479517|BG001|Baseline|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
11082271|NCT01479517|BG002|Baseline|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
11082272|NCT01479517|BG003|Baseline|Total|Total of all reporting groups
11082273|NCT01479517|FG000|Participant Flow|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
11082274|NCT01479517|FG001|Participant Flow|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
11082275|NCT01479517|FG002|Participant Flow|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
11082276|NCT01479517|OG000|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
11082277|NCT01479517|OG001|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
11082278|NCT01479517|OG002|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
11082279|NCT01479517|EG000|Reported Event|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
11082280|NCT01479517|EG001|Reported Event|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
11082281|NCT01479517|EG002|Reported Event|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
11082282|NCT01479530|BG000|Baseline|Placebo|Once daily; tablet; orally; 16 weeks
11082283|NCT01479530|BG001|Baseline|Azilect®|1 mg daily; tablet; orally; 16 weeks
11082284|NCT01479530|BG002|Baseline|Total|Total of all reporting groups
11227590|NCT02384070|EG000|Reported Event|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
11082285|NCT01479530|FG000|Participant Flow|Placebo|Once daily; tablet; orally; 16 weeks
11082286|NCT01479530|FG001|Participant Flow|Azilect®|1 mg daily; tablet; orally; 16 weeks
11082287|NCT01479530|OG000|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
11082288|NCT01479530|OG001|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
11082289|NCT01479530|EG000|Reported Event|Placebo|Once daily; tablet; orally; 16 weeks
11082290|NCT01479530|EG001|Reported Event|Azilect®|1 mg daily; tablet; orally; 16 weeks
11082291|NCT01479543|BG000|Baseline|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082292|NCT01479543|BG001|Baseline|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082293|NCT01479543|BG002|Baseline|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082294|NCT01479543|BG003|Baseline|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082295|NCT01479543|BG004|Baseline|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
11082296|NCT01479543|BG005|Baseline|Total|Total of all reporting groups
11082297|NCT01479543|FG000|Participant Flow|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082298|NCT01479543|FG001|Participant Flow|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082299|NCT01479543|FG002|Participant Flow|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082300|NCT01479543|FG003|Participant Flow|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082301|NCT01479543|FG004|Participant Flow|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
11082302|NCT01479543|OG000|Outcome|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082303|NCT01479543|OG001|Outcome|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082304|NCT01479543|OG002|Outcome|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082305|NCT01479543|OG003|Outcome|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082306|NCT01479543|OG004|Outcome|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
11082307|NCT01479543|EG000|Reported Event|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082308|NCT01479543|EG001|Reported Event|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082309|NCT01479543|EG002|Reported Event|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
11233761|NCT02431052|OG002|Outcome|Olumacostat Glasaretil Gel, 4.0% QD|Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
11233762|NCT02431052|OG003|Outcome|Olumacostat Glasaretil Gel, 7.5% QD|Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
11082310|NCT01479543|EG003|Reported Event|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
11082311|NCT01479543|EG004|Reported Event|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
11082312|NCT01479595|BG000|Baseline|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
11082313|NCT01479595|BG001|Baseline|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
11082314|NCT01479595|BG002|Baseline|Total|Total of all reporting groups
11082315|NCT01479595|FG000|Participant Flow|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
11082316|NCT01479595|FG001|Participant Flow|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
11082317|NCT01479595|OG000|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
11082318|NCT01479595|OG001|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
11082319|NCT01479595|EG000|Reported Event|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
11082320|NCT01479595|EG001|Reported Event|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
11082321|NCT01479621|BG000|Baseline|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082322|NCT01479621|BG001|Baseline|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082323|NCT01479621|BG002|Baseline|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082324|NCT01479621|BG003|Baseline|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082325|NCT01479621|BG004|Baseline|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
11082326|NCT01479621|BG005|Baseline|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082327|NCT01479621|BG006|Baseline|Total|Total of all reporting groups
11082328|NCT01479621|FG000|Participant Flow|Placebo MDPI (Run-In)|Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).
11082329|NCT01479621|FG001|Participant Flow|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082330|NCT01479621|FG002|Participant Flow|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082331|NCT01479621|FG003|Participant Flow|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082332|NCT01479621|FG004|Participant Flow|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082333|NCT01479621|FG005|Participant Flow|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
11091995|NCT01537042|BG000|Baseline|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
11082334|NCT01479621|FG006|Participant Flow|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082335|NCT01479621|OG000|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082336|NCT01479621|OG001|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082337|NCT01479621|OG002|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082338|NCT01479621|OG003|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082339|NCT01479621|OG004|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
11082340|NCT01479621|OG005|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
11082341|NCT01479621|EG000|Reported Event|Flovent Diskus 100mcg|Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
11082342|NCT01479621|EG001|Reported Event|Fp MDPI 100 mcg|Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
11082343|NCT01479621|EG002|Reported Event|Fp MDPI 12.5 mcg|Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
11082344|NCT01479621|EG003|Reported Event|Fp MDPI 25 mcg|Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
11082345|NCT01479621|EG004|Reported Event|Fp MDPI 50 mcg|Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
11082346|NCT01479621|EG005|Reported Event|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
11082347|NCT01479725|BG000|Baseline|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
11082348|NCT01479725|BG001|Baseline|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
11082349|NCT01479725|BG002|Baseline|Total|Total of all reporting groups
11082350|NCT01479725|FG000|Participant Flow|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
11082351|NCT01479725|FG001|Participant Flow|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
11082352|NCT01479725|OG000|Outcome|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
11082353|NCT01479725|OG001|Outcome|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
11082354|NCT01479725|EG000|Reported Event|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
11082355|NCT01479725|EG001|Reported Event|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
11082356|NCT01479764|BG000|Baseline|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
11082357|NCT01479764|BG001|Baseline|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
11082358|NCT01479764|BG002|Baseline|Total|Total of all reporting groups
11082359|NCT01479764|FG000|Participant Flow|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
11082360|NCT01479764|FG001|Participant Flow|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
11082361|NCT01479764|OG000|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
11082362|NCT01479764|OG001|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
11082363|NCT01479764|EG000|Reported Event|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
11082364|NCT01479764|EG001|Reported Event|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
11082365|NCT01479777|BG000|Baseline|FES Stepping|FES Stepping, twice a week, for 8 weeks.
11082366|NCT01479777|FG000|Participant Flow|FES Stepping|For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping.
11082367|NCT01479777|OG000|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
11082368|NCT01479777|EG000|Reported Event|FES Stepping|FES Stepping, twice a week, for 8 weeks.
11082369|NCT01479868|BG000|Baseline|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
11082370|NCT01479868|FG000|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
11082371|NCT01479868|OG000|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
11082372|NCT01479868|EG000|Reported Event|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
11082373|NCT01479985|BG000|Baseline|CDM Tool|"participants will be randomized to completing the CDM tool~CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers"
11227591|NCT02384070|EG001|Reported Event|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
11227592|NCT02384070|EG002|Reported Event|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
11082374|NCT01479985|BG001|Baseline|Control|Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
11082375|NCT01479985|BG002|Baseline|Total|Total of all reporting groups
11082376|NCT01479985|FG000|Participant Flow|CDM Tool|"participants will be randomized to completing the CDM tool~CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers"
11082377|NCT01479985|FG001|Participant Flow|Control|Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
11082378|NCT01479985|OG000|Outcome|CDM Tool|"participants will be randomized to completing the CDM tool~CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers"
11082379|NCT01479985|OG001|Outcome|Control|Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
11082380|NCT01479985|EG000|Reported Event|CDM Tool|"participants will be randomized to completing the CDM tool~CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers"
11082381|NCT01479985|EG001|Reported Event|Control|Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
11082382|NCT01480076|BG000|Baseline|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks.
11082383|NCT01480076|BG001|Baseline|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
11082384|NCT01480076|BG002|Baseline|Total|Total of all reporting groups
11082385|NCT01480076|FG000|Participant Flow|Fampridine|All participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
11082386|NCT01480076|OG000|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
11233763|NCT02431052|OG004|Outcome|Olumacostat Glasaretil Gel, 7.5% BID|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
11082387|NCT01480076|OG001|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
11082388|NCT01480076|OG000|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
11082389|NCT01480076|OG001|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
11082390|NCT01480076|OG002|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
11082391|NCT01480076|OG003|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
11082392|NCT01480076|OG000|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
11082393|NCT01480076|OG001|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
11082394|NCT01480076|OG002|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
11082395|NCT01480076|OG003|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
11082396|NCT01480076|OG002|Outcome|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
11082397|NCT01480076|EG000|Reported Event|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
11082398|NCT01480076|EG001|Reported Event|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
11082399|NCT01480076|EG002|Reported Event|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
11082400|NCT01480089|BG000|Baseline|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
11082401|NCT01480089|BG001|Baseline|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
11082402|NCT01480089|BG002|Baseline|Total|Total of all reporting groups
11082403|NCT01480089|FG000|Participant Flow|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
11082404|NCT01480089|FG001|Participant Flow|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
11082405|NCT01480089|OG000|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
11082406|NCT01480089|OG001|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
11082407|NCT01480089|EG000|Reported Event|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
11082408|NCT01480089|EG001|Reported Event|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
11082409|NCT01480219|BG000|Baseline|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
11082410|NCT01480219|BG001|Baseline|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
11082411|NCT01480219|BG002|Baseline|Total|Total of all reporting groups
11082412|NCT01480219|FG000|Participant Flow|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
11082413|NCT01480219|FG001|Participant Flow|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
11082414|NCT01480219|OG000|Outcome|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
11082415|NCT01480219|OG001|Outcome|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
11082416|NCT01480219|EG000|Reported Event|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
11082417|NCT01480219|EG001|Reported Event|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
11082418|NCT01480232|BG000|Baseline|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082419|NCT01480232|BG001|Baseline|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082420|NCT01480232|BG002|Baseline|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082421|NCT01480232|BG003|Baseline|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082422|NCT01480232|BG004|Baseline|Total|Total of all reporting groups
11082423|NCT01480232|FG000|Participant Flow|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082424|NCT01480232|FG001|Participant Flow|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT (nicotine replacement therapy) Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082425|NCT01480232|FG002|Participant Flow|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082426|NCT01480232|FG003|Participant Flow|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082427|NCT01480232|OG000|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082428|NCT01480232|OG001|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082429|NCT01480232|OG002|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11091996|NCT01537042|BG001|Baseline|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
11082430|NCT01480232|OG003|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082431|NCT01480232|EG000|Reported Event|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082432|NCT01480232|EG001|Reported Event|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082433|NCT01480232|EG002|Reported Event|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082434|NCT01480232|EG003|Reported Event|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
11082435|NCT01480258|BG000|Baseline|PR5I|Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age [subset 1] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age [subset 2]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
11082436|NCT01480258|BG001|Baseline|INFANRIX™ Hexa|Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age [subset 1] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age [subset 2]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
11082437|NCT01480258|BG002|Baseline|Total|Total of all reporting groups
11082438|NCT01480258|FG000|Participant Flow|PR5I|Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age [subset 1] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age [subset 2]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
11082439|NCT01480258|FG001|Participant Flow|INFANRIX™ Hexa|Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age [subset 1] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age [subset 2]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
11227593|NCT02384096|BG000|Baseline|Conventional Programming, Then Advanced Programming|"Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming.~Conventional single source programming: Precision Spectra SCS System using conventional single source programming.~Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming."
11227594|NCT02384096|BG001|Baseline|Advanced Programming, Then Conventional Programming|"Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming.~Conventional single source programming: Precision Spectra SCS System using conventional single source programming.~Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming."
11227595|NCT02384096|BG002|Baseline|Total|Total of all reporting groups
11227596|NCT02384096|FG000|Participant Flow|Conventional Programming, Then Advanced Programming|"Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming.~Conventional single source programming: Precision Spectra SCS System using conventional single source programming.~Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming."
11227597|NCT02384096|FG001|Participant Flow|Advanced Programming, Then Conventional Programming|"Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming.~Conventional single source programming: Precision Spectra SCS System using conventional single source programming.~Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming."
11233764|NCT02431052|EG000|Reported Event|Olumacostat Glasaretil Gel, Vehicle QD|Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
11233765|NCT02431052|EG001|Reported Event|Olumacostat Glasaretil Gel, Vehicle BID|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11227598|NCT02384096|OG000|Outcome|Conventional Programming, Then Advanced Programming|"Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming.~Conventional single source programming: Precision Spectra SCS System using conventional single source programming.~Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming."
11227599|NCT02384096|OG001|Outcome|Advanced Programming, Then Conventional Programming|"Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming.~Conventional single source programming: Precision Spectra SCS System using conventional single source programming.~Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming."
11082440|NCT01480258|OG000|Outcome|PR5I|Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age [subset 1] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age [subset 2]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
11082441|NCT01480258|OG001|Outcome|INFANRIX™ Hexa|Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age [subset 1] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age [subset 2]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
11082442|NCT01480258|EG000|Reported Event|PR5I|Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age [subset 1] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age [subset 2]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
11082443|NCT01480258|EG001|Reported Event|INFANRIX™ Hexa|Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age [subset 1] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age [subset 2]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
11082444|NCT01480284|BG000|Baseline|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
11082445|NCT01480284|BG001|Baseline|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
11082446|NCT01480284|BG002|Baseline|Total|Total of all reporting groups
11082447|NCT01480284|FG000|Participant Flow|TDF 300 mg OD|Participants received Tenofovir Disoproxil Fumarate (TDF) 300 milligrams (mg) tablet once daily (OD) and Entecavir Hydrate (ETV) placebo capsule OD for 96 weeks.
11082448|NCT01480284|FG001|Participant Flow|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
11082449|NCT01480284|OG000|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
11082450|NCT01480284|OG001|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
11082451|NCT01480284|EG000|Reported Event|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
11082452|NCT01480284|EG001|Reported Event|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
11082453|NCT01480297|BG000|Baseline|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
11082454|NCT01480297|FG000|Participant Flow|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
11082455|NCT01480297|OG000|Outcome|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
11082456|NCT01480297|EG000|Reported Event|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
11082457|NCT01480596|BG000|Baseline|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
11082458|NCT01480596|BG001|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
11082459|NCT01480596|BG002|Baseline|Total|Total of all reporting groups
11082460|NCT01480596|FG000|Participant Flow|Placebo IV|Participants received 250 milliliter (ml) of a normal saline placebo administered as intravenous (IV) infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
11082461|NCT01480596|FG001|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
11227600|NCT02384096|EG000|Reported Event|All Enrolled Subjects|Rate of device-related adverse events (AEs) and Serious Adverse Events (SAEs) are reported for 17 enrolled subjects from informed consent through completion of study.
11233766|NCT02431052|EG002|Reported Event|Olumacostat Glasaretil Gel, 4.0% QD|Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
11082462|NCT01480596|OG000|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
11091997|NCT01537042|BG002|Baseline|Total|Total of all reporting groups
11082463|NCT01480596|OG001|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
11082464|NCT01480596|EG000|Reported Event|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
11082465|NCT01480596|EG001|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
11082466|NCT01480674|BG000|Baseline|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
11082467|NCT01480674|FG000|Participant Flow|Trastuzumab|Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab (Herceptin) as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
11082468|NCT01480674|OG000|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
11082469|NCT01480674|EG000|Reported Event|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
11082470|NCT01480843|BG000|Baseline|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
11082471|NCT01480843|FG000|Participant Flow|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
11082472|NCT01480843|OG000|Outcome|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
11082473|NCT01480843|EG000|Reported Event|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
11082474|NCT01481116|BG000|Baseline|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
11082475|NCT01481116|BG001|Baseline|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
11082476|NCT01481116|BG002|Baseline|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
11082477|NCT01481116|BG003|Baseline|Total|Total of all reporting groups
11082478|NCT01481116|FG000|Participant Flow|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
11082479|NCT01481116|FG001|Participant Flow|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
11082480|NCT01481116|FG002|Participant Flow|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
11082481|NCT01481116|OG000|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
11082482|NCT01481116|OG001|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
11082483|NCT01481116|OG002|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
11082484|NCT01481116|EG000|Reported Event|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
11082485|NCT01481116|EG001|Reported Event|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
11082486|NCT01481116|EG002|Reported Event|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
11082487|NCT01481129|BG000|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11082488|NCT01481129|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11082489|NCT01481129|OG000|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11082490|NCT01481129|EG000|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11082491|NCT01481324|BG000|Baseline|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
11082492|NCT01481324|BG001|Baseline|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
11082493|NCT01481324|BG002|Baseline|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
11082494|NCT01481324|BG003|Baseline|Total|Total of all reporting groups
11082495|NCT01481324|FG000|Participant Flow|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
11082496|NCT01481324|FG001|Participant Flow|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
11082497|NCT01481324|FG002|Participant Flow|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
11082498|NCT01481324|OG000|Outcome|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
11082499|NCT01481324|OG001|Outcome|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
11082500|NCT01481324|OG002|Outcome|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
11082501|NCT01481324|EG000|Reported Event|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
11082502|NCT01481324|EG001|Reported Event|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
11082503|NCT01481324|EG002|Reported Event|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
11082504|NCT01481376|BG000|Baseline|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
11082505|NCT01481376|FG000|Participant Flow|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
11082506|NCT01481376|OG000|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
11082507|NCT01481376|EG000|Reported Event|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
11082508|NCT01481545|BG000|Baseline|Concomitant - Schedule A|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 2 weeks before the start of chemoradiotherapy, and on the same day of chemotherapy for 3 cycles (concomitant-schedule A)"
11082509|NCT01481545|BG001|Baseline|Sequential - Schedule B|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 4 days prior to the first and second cycle of chemotherapy (sequential-schedule B)."
11082510|NCT01481545|BG002|Baseline|Total|Total of all reporting groups
11082511|NCT01481545|FG000|Participant Flow|Concomitant - Schedule A|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 2 weeks before the start of chemoradiotherapy, and on the same day of chemotherapy for 3 cycles (concomitant-schedule A)"
11082512|NCT01481545|FG001|Participant Flow|Sequential - Schedule B|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 4 days prior to the first and second cycle of chemotherapy (sequential-schedule B)."
11082513|NCT01481545|OG000|Outcome|Concomitant - Schedule A|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 2 weeks before the start of chemoradiotherapy, and on the same day of chemotherapy for 3 cycles (concomitant-schedule A)"
11082514|NCT01481545|OG001|Outcome|Sequential - Schedule B|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 4 days prior to the first and second cycle of chemotherapy (sequential-schedule B)."
11082515|NCT01481545|OG000|Outcome|Sequential - Schedule B|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 4 days prior to the first and second cycle of chemotherapy (sequential-schedule B)."
11082516|NCT01481545|OG001|Outcome|Concomitant - Schedule A|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 2 weeks before the start of chemoradiotherapy, and on the same day of chemotherapy for 3 cycles (concomitant-schedule A)"
11082517|NCT01481545|EG000|Reported Event|Concomitant - Schedule A|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 2 weeks before the start of chemoradiotherapy, and on the same day of chemotherapy for 3 cycles (concomitant-schedule A)"
11082518|NCT01481545|EG001|Reported Event|Sequential - Schedule B|"Preoperative radiation therapy and combination chemotherapy plus bevacizumab~Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 4 days prior to the first and second cycle of chemotherapy (sequential-schedule B)."
11082519|NCT01481558|BG000|Baseline|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
11082520|NCT01481558|BG001|Baseline|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
11082521|NCT01481558|BG002|Baseline|Total|Total of all reporting groups
11082522|NCT01481558|FG000|Participant Flow|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
11082523|NCT01481558|FG001|Participant Flow|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
11082524|NCT01481558|OG000|Outcome|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
11082525|NCT01481558|OG001|Outcome|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
11082526|NCT01481558|EG000|Reported Event|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
11082527|NCT01481558|EG001|Reported Event|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
11082528|NCT01481740|BG000|Baseline|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
11082529|NCT01481740|BG001|Baseline|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
11082530|NCT01481740|BG002|Baseline|Total|Total of all reporting groups
11082531|NCT01481740|FG000|Participant Flow|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
11082532|NCT01481740|FG001|Participant Flow|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
11082533|NCT01481740|OG000|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
11082534|NCT01481740|OG001|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
11082535|NCT01481740|EG000|Reported Event|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
11082536|NCT01481740|EG001|Reported Event|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
11082537|NCT01481779|BG000|Baseline|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
11082538|NCT01481779|BG001|Baseline|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
11082539|NCT01481779|BG002|Baseline|Total|Total of all reporting groups
11082540|NCT01481779|FG000|Participant Flow|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
11082541|NCT01481779|FG001|Participant Flow|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
11082542|NCT01481779|OG000|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
11082543|NCT01481779|OG001|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
11082544|NCT01481779|EG000|Reported Event|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered subcutaneously via pen device at meal times for 78 weeks.
11233767|NCT02431052|EG003|Reported Event|Olumacostat Glasaretil Gel, 7.5% QD|Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
11082545|NCT01481779|EG001|Reported Event|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
11082546|NCT01481896|BG000|Baseline|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
11082547|NCT01481896|FG000|Participant Flow|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
11082548|NCT01481896|OG000|Outcome|Patients With Serum Cobalt Levels|Patients were recommended to have blood drawn for evaluation of serum cobalt levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. Among all the labs that performed metal level assessments, the cobalt detection limit varied from 0.5 to 1.0 microgram per liter. Patients with undetectable cobalt levels were assigned a value of zero. A patient's cobalt level was considered high if it was 7 micrograms per liter or greater.
11082549|NCT01481896|OG001|Outcome|Patients With Serum Chromium Levels|Patients were recommended to have blood drawn for evaluation of serum chromium levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. The chromium detection limit was 0.1 micrograms per liter for all labs that performed metal level assessments. Patients with undetectable chromium levels were assigned a value of zero. A patient's chromium level was considered high if it was 7 micrograms per liter or greater.
11082550|NCT01481896|OG000|Outcome|Cup Abduction Angle|The Cup Abduction Angle quantifies the amount of tilt associated with the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the angle between the face of the cup and a horizontal line defines the Cup Abduction Angle. The line defining the face of the cup is drawn through the uppermost and lowest edges of the cup's projection on the x-ray. For this study, the Cup Abduction Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL).
11082551|NCT01481896|OG001|Outcome|Cup Anteversion Angle|The Cup Anteversion Angle quantifies the front-to-back rotation of the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the circular face of the cup projects onto the x-ray as an ellipse. The ratio of the major axis of the ellipse to the minor axis can be used to calculate the anteversion. A cup rotated anteriorly has positive anteversion. A cup rotated posteriorly has negative anteversion. For this study, the cup Anteversion Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL). Taken together, the abduction and anteversion angle quantify the three-dimensional orientation of the cup.
11082552|NCT01481896|OG000|Outcome|Hips With Harris Hip Scores|The Harris Hip Score is an outcome measure used for hip replacements that ranges from 0 (worst) to 100 (best). The score consists of a series of questions related to hip pain, function and range of motion that accumulate a different number of points depending on the response choices. At the time of their follow-up visits, patients completed a standardized questionnaire that included components of the Harris Hip Score and the physician completed a standardized evaluation which included range of motion assessment.
11082553|NCT01481896|OG000|Outcome|Hips With Radiographs Analyzed for Femoral Osteolysis|Serial x-rays for each hip replacement were analyzed by a single experienced reviewer to identify regions where bone had been lost in the femur. Expansile (ballooned-out) regions of bone loss identified on follow-up x-rays taken at least 4.75 years after their surgery that were not apparent on the immediate post-operative x-ray were considered to be osteolysis. For the purposes of reporting, the total number of hips with any evidence of femoral osteolysis on x-ray is indicated.
11082554|NCT01481896|OG001|Outcome|Hips With CT Scans Analyzed for Pelvic Osteolysis|Digital Computed Tomography (CT) scans taken more than 5 years after a patient's hip replacement were used to evaluate pelvic bone loss (osteolysis). Regions of bone loss were traced on CT slices to determine the volume and location of each osteolytic defect using three-dimensional image analysis software (Analyze, Biomedical Imaging Resource, Rochester, MN). For the purposes of reporting, the total number of hips with any evidence of pelvic osteolysis on CT is indicated.
11082555|NCT01481896|OG000|Outcome|Stem Stability|"Based on the most recent follow-up x-ray, the fixation of the stem component implanted in a patient's femur was graded as bone ingrown, fibrous stable or loose using the criteria defined by Engh, Massin and Suthers in their article titled Roentgenographic assessment of the biologic fixation of porous-surfaced femoral components published in the August 1990 edition of Clinical Orthopaedics and Related Research on pages 107 to 128."
11082556|NCT01481896|OG001|Outcome|Cup Stability|Based on the most recent follow-up x-ray, the fixation of the cup component implanted in a patient's pelvis was graded as bone ingrown, fibrous stable or loose. A cup was considered fibrous stable if there was a continuous radiolucent line along the interface between the cup and the patient's pelvic bone. A cup was considered loose if it had migrated more than 2 mm or its orientation had changed by at least 5 degrees on the follow-up x-ray compared to the immediate post-operative x-ray. A cup that did not meet the criteria for fibrous stable or loose was considered bone ingrown.
11227601|NCT02384200|BG000|Baseline|Antibiotic|"1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).~In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.~nitrofurantoin monohydrate/macrocrystalline capsules: 1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily~ampicillin: IV (2 g)~gentamicin: IV (5 mg/kg)~vancomycin: IV (1 g)~ceftriaxone: IV (2 g)"
11233768|NCT02431052|EG004|Reported Event|Olumacostat Glasaretil Gel, 7.5% BID|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
11082557|NCT01481896|OG000|Outcome|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
11082558|NCT01481896|OG000|Outcome|Patients Satisfied With Outcome of Hip Replacement|"Patient satisfaction was evaluated by asking the question, Are you satisfied with the results of your hip operation? on a questionnaire. Patients could respond Yes or No by filling in the appropriated bubble on the questionnaire."
11082559|NCT01481896|EG000|Reported Event|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
11082560|NCT01482065|BG000|Baseline|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
11082561|NCT01482065|BG001|Baseline|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
11082562|NCT01482065|BG002|Baseline|Total|Total of all reporting groups
11082563|NCT01482065|FG000|Participant Flow|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
11082564|NCT01482065|FG001|Participant Flow|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
11082565|NCT01482065|OG000|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
11349127|NCT04117607|FG011|Participant Flow|MAD Placebo|"Placebo participants across all MAD cohorts: 30 mg (1 injection of 0.3 mL), 60 mg (1 injection of 0.6 ml), 100 mg (1 injection of 1.0 ml), 200 mg (2 injections of 1.0 ml), of matching placebo administered subcutaneously as three doses on Days 1, 8, and 15 in a double-blind manner. The 200 mg dose injections will be administered in the same abdominal quadrant, separated by approximately 5 cm. Each dose will be administered in a different quadrant (3 quadrants total).~Placebo: 5% Dextrose Injection, USP, a sterile, nonpyrogenic solution of dextrose in water for injection. The solution has the osmolarity of 252 mOsmol/L, which is slightly hypotonic. This solution contains no bacteriostat, antimicrobial agent or added buffer."
11357471|NCT03757234|EG003|Reported Event|Omadacycline 200 iv/450 po or 100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
11091998|NCT01537042|FG000|Participant Flow|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance.~Up to 3 weeks of Titration,~2 weeks of Maintenance,~Up to 4 days of Taper Period."
11091999|NCT01537042|FG001|Participant Flow|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.~Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal."
11082566|NCT01482065|OG001|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
11082567|NCT01482065|EG000|Reported Event|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
11082568|NCT01482065|EG001|Reported Event|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
11082569|NCT01482091|BG000|Baseline|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
11082570|NCT01482091|BG001|Baseline|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
11082571|NCT01482091|BG002|Baseline|Total|Total of all reporting groups
11082572|NCT01482091|FG000|Participant Flow|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
11082573|NCT01482091|FG001|Participant Flow|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
11082574|NCT01482091|OG000|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
11082575|NCT01482091|OG001|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
11082576|NCT01482091|EG000|Reported Event|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
11082577|NCT01482091|EG001|Reported Event|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
11082578|NCT01482169|BG000|Baseline|Adenoscan + Regadenoson|"Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson~FFR Measurement with IV Adenoscan® then with Regadenoson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny."
11082579|NCT01482169|FG000|Participant Flow|Adenoscan + Regadenoson|"Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson~FFR Measurement with IV Adenoscan® then with Regadenoson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny."
11082580|NCT01482169|OG000|Outcome|Adenoscan|"Subjects will have the FFR Measurement with IV Adenoscan®~FFR Measurement with IV Adenoscan®: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®."
11082581|NCT01482169|OG001|Outcome|Regadenoson|"Subjects will have the FFR Measurement with IV Regadenson~FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved."
11082582|NCT01482169|OG000|Outcome|Duration to Baseline Hyperemia After Aminophylline Administrat|After subjects have the FFR measurement with Regadenoson, they will be administered aminophylline 150mg IV and the time duration to reach baseline hyperemia will be recorded.
11082583|NCT01482169|EG000|Reported Event|Adenoscan|"Subjects will have the FFR Measurement with IV Adenoscan®~FFR Measurement with IV Adenoscan®: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®."
11082584|NCT01482169|EG001|Reported Event|Regadenson|"Subjects will have the FFR Measurement with IV Regadenson~FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved."
11082585|NCT01482221|BG000|Baseline|AZD6765 50 mg|Intravenous infusion
11082586|NCT01482221|BG001|Baseline|AZD6765 100 mg|Intravenous infusion
11082587|NCT01482221|BG002|Baseline|Placebo|Intravenous infusion
11227602|NCT02384200|BG001|Baseline|No Preoperative Oral Antibiotics|"Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.~ampicillin: IV (2 g)~gentamicin: IV (5 mg/kg)~vancomycin: IV (1 g)~ceftriaxone: IV (2 g)"
11227603|NCT02384200|BG002|Baseline|Total|Total of all reporting groups
11082588|NCT01482221|BG003|Baseline|Total|Total of all reporting groups
11082589|NCT01482221|FG000|Participant Flow|AZD6765 50 mg|Intravenous infusion
11082590|NCT01482221|FG001|Participant Flow|AZD6765 100 mg|Intravenous infusion
11082591|NCT01482221|FG002|Participant Flow|Placebo|Intravenous infusion
11082592|NCT01482221|OG000|Outcome|AZD6765 50 mg|Intravenous infusion
11082593|NCT01482221|OG001|Outcome|AZD6765 100 mg|Intravenous infusion
11082594|NCT01482221|OG002|Outcome|Placebo|Intravenous infusion
11082595|NCT01482221|EG000|Reported Event|AZD6765iv 100 mg|Intravenous infusion
11082596|NCT01482221|EG001|Reported Event|AZD6765iv 50 mg|Intravenous infusion
11082597|NCT01482221|EG002|Reported Event|Placebo|Intravenous infusion
11082598|NCT01482312|BG000|Baseline|Overall|This reporting group includes all enrolled participants.
11082599|NCT01482312|FG000|Participant Flow|Lotrafilcon A / Comfilcon A / Glasses|Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
11082600|NCT01482312|FG001|Participant Flow|Comfilcon A / Glasses / Lotrafilcon A|Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
11082601|NCT01482312|FG002|Participant Flow|Glasses / Lotrafilcon A / Comfilcon A|Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
11082602|NCT01482312|OG000|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
11082603|NCT01482312|OG001|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
11082604|NCT01482312|OG002|Outcome|Glasses|Glasses per habitual prescription
11082605|NCT01482312|EG000|Reported Event|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
11082606|NCT01482312|EG001|Reported Event|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
11082607|NCT01482312|EG002|Reported Event|Glasses|Glasses per habitual prescription
11082608|NCT01482351|BG000|Baseline|MCI/OSA/CPAP Adherent|"Device: Continuous Positive Airway Pressure [CPAP]. Included those diagnosed with mild cognitive impairment (MCI) and obstructive sleep apnea (OSA). The diagnostic criteria for OSA was defined as an Apnea Hypopnea Index (AHI) score of greater than or equal to 10. CPAP was prescribed for nightly use. Mean CPAP use equal to or greater than 4 hours per night over one year.~Continuous Positive Airway Pressure [CPAP]: Study participants with sleep apnea will choose to use or not use a continuous positive airway pressure (CPAP) machine to treat their apnea after a consultation with their doctor. Dosage of CPAP will be individually determined using standardized methods in an overnight CPAP titration polysomnography."
11092000|NCT01537042|OG000|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
11092001|NCT01537042|OG001|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
11233769|NCT02431260|BG000|Baseline|Part 1 / Treatment Group A: 15 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11233770|NCT02431260|BG001|Baseline|Part 1 / Treatment Group A: 22.5 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11082609|NCT01482351|BG001|Baseline|MCI/OSA/CPAP Non-adherent|"Device: Continuous Positive Airway Pressure [CPAP]. Included those diagnosed with mild cognitive impairment (MCI) and obstructive sleep apnea (OSA). The diagnostic criteria for OSA was defined as an Apnea Hypopnea Index (AHI) score of greater than or equal to 10. CPAP was prescribed for nightly use. Mean CPAP use less than 4 hours per night over one year.~Continuous Positive Airway Pressure [CPAP]: Study participants with sleep apnea will choose to use or not use a continuous positive airway pressure (CPAP) machine to treat their apnea after a consultation with their doctor. Dosage of CPAP will be individually determined using standardized methods in an overnight CPAP titration polysomnography."
11082610|NCT01482351|BG002|Baseline|Total|Total of all reporting groups
11082611|NCT01482351|FG000|Participant Flow|Experimental: MCI/OSA/CPAP Adherent and Non-adherent|All participants were diagnosed with MCI and OSA. The diagnostic criteria for OSA was defined as an AHI score greater than or equal to 10. CPAP was prescribed for nightly use. At baseline there were 68 participants had OSA (AHI ≥10). 14 persons withdrew prior to 6 month testing. There were 54 active MCI participants with OSA at 6 months and 12 month: 29 were CPAP adherent and 25 were CPAP non-adherent.
11082612|NCT01482351|OG000|Outcome|MCI/OSA/CPAP Adherent|"Device: Continuous Positive Airway Pressure [CPAP]. Included those diagnosed with mild cognitive impairment (MCI) and obstructive sleep apnea (OSA). The diagnostic criteria for OSA was defined as an Apnea Hypopnea Index (AHI) score of greater than or equal to 10. CPAP was prescribed for nightly use. Mean CPAP use equal to or greater than 4 hours per night over one year.~Continuous Positive Airway Pressure [CPAP]: Study participants with sleep apnea will choose to use or not use a continuous positive airway pressure (CPAP) machine to treat their apnea after a consultation with their doctor. Dosage of CPAP will be individually determined using standardized methods in an overnight CPAP titration polysomnography."
11082613|NCT01482351|OG001|Outcome|MCI/OSA/CPAP Non-adherent|"Device: Continuous Positive Airway Pressure [CPAP]. Included those diagnosed with mild cognitive impairment (MCI) and obstructive sleep apnea (OSA). The diagnostic criteria for OSA was defined as an Apnea Hypopnea Index (AHI) score of greater than or equal to 10. CPAP prescribed for nightly use. Mean CPAP use less than 4 hours per night over one year.~Continuous Positive Airway Pressure [CPAP]: Study participants with sleep apnea will choose to use or not use a continuous positive airway pressure (CPAP) machine to treat their apnea after a consultation with their doctor. Dosage of CPAP will be individually determined using standardized methods in an overnight CPAP titration polysomnography."
11082614|NCT01482351|OG000|Outcome|MCI-OSA|Participants who completed the study and had Alzheimer's Disease Clinician's Scale (ADCS) data adjusted for age, race, and marital status.
11082615|NCT01482351|OG000|Outcome|MCI-OSA|Participants who completed the study and had Clinical Dementia Rating data.
11082616|NCT01482351|EG000|Reported Event|MCI/OSA/CPAP Adherent|Device: CPAP. Included those diagnosed with MCI and OSA. The diagnostic criteria for OSA was defined as an AHI score of greater than or equal to 10. CPAP was prescribed for nightly use. Mean CPAP use equal to or greater than 4 hours per night over one year.
11082617|NCT01482351|EG001|Reported Event|MCI/OSA/CPAP Non-adherent|Device: CPAP. Included those diagnosed with MCI and OSA. The diagnostic criteria for OSA was defined as an AHI score of greater than or equal to 10. CPAP was prescribed for nightly use. Mean CPAP use less than 4 hours per night over one year.
11082618|NCT01482429|BG000|Baseline|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
11082619|NCT01482429|BG001|Baseline|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
11082620|NCT01482429|BG002|Baseline|Total|Total of all reporting groups
11082621|NCT01482429|FG000|Participant Flow|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
11227604|NCT02384200|FG000|Participant Flow|Antibiotic|"1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).~In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.~nitrofurantoin monohydrate/macrocrystalline capsules: 1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily~ampicillin: IV (2 g)~gentamicin: IV (5 mg/kg)~vancomycin: IV (1 g)~ceftriaxone: IV (2 g)"
11082622|NCT01482429|FG001|Participant Flow|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
11082623|NCT01482429|OG000|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
11082624|NCT01482429|OG001|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
11082625|NCT01482429|EG000|Reported Event|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
11227605|NCT02384200|FG001|Participant Flow|No Preoperative Oral Antibiotics|"Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.~ampicillin: IV (2 g)~gentamicin: IV (5 mg/kg)~vancomycin: IV (1 g)~ceftriaxone: IV (2 g)"
11233771|NCT02431260|BG002|Baseline|Part 1 / Treatment Group A: 15 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11082626|NCT01482429|EG001|Reported Event|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
11092002|NCT01537042|OG000|Outcome|Placebo (Visit 2)|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
11092003|NCT01537042|OG001|Outcome|Rotigotine (Visit 2)|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
11092004|NCT01537042|OG002|Outcome|Placebo (Visit 6)|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
11092005|NCT01537042|OG003|Outcome|Rotigotine (Visit 6)|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
11082627|NCT01482715|BG000|Baseline|Rucaparib 40 mg QD (Part 1)|Rucaparib 40 mg QD for continuous 21-day cycles
11082628|NCT01482715|BG001|Baseline|Rucaparib 80 mg QD (Part 1)|Rucaparib 80 mg QD for continuous 21-day cycles
11082629|NCT01482715|BG002|Baseline|Rucaparib 160 mg QD (Part 1)|Rucaparib 160 mg QD for continuous 21-day cycles
11082630|NCT01482715|BG003|Baseline|Rucaparib 300 mg QD (Part 1)|Rucaparib 300 mg QD for continuous 21-day cycles
11082631|NCT01482715|BG004|Baseline|Rucaparib 500 mg QD (Part 1)|Rucaparib 500 mg QD for continuous 21-day cycles
11082632|NCT01482715|BG005|Baseline|Rucaparib 240 mg BID (Part 1)|Rucaparib 240 mg BID for continuous 21-day cycles
11082633|NCT01482715|BG006|Baseline|Rucaparib 360 mg BID (Part 1)|Rucaparib 360 mg BID for continuous 21-day cycles
11082634|NCT01482715|BG007|Baseline|Rucaparib 480 mg BID (Part 1)|Rucaparib 480 mg BID for continuous 21-day cycles
11082635|NCT01482715|BG008|Baseline|Rucaparib 600 mg BID (Part 1)|Rucaparib 600 mg BID for continuous 21-day cycles
11082636|NCT01482715|BG009|Baseline|Rucaparib 840 mg BID (Part 1)|Rucaparib 840 mg BID for continuous 21-day cycles
11082637|NCT01482715|BG010|Baseline|Rucaparib 600 mg BID (Part 2A)|Rucaparib 600 mg BID for continuous 21-day cycles
11082638|NCT01482715|BG011|Baseline|Rucaparib 600 mg BID (Part 2B)|Rucaparib 600 mg BID for continuous 21-day cycles
11082639|NCT01482715|BG012|Baseline|Rucaparib 600 mg BID (Part 3)|Rucaparib 600 mg BID for continuous 21-day cycles
11082640|NCT01482715|BG013|Baseline|Total|Total of all reporting groups
11082641|NCT01482715|FG000|Participant Flow|Rucaparib 40 mg QD (Part 1)|Rucaparib 40 mg once a day (QD) for continuous 21-day cycles
11082642|NCT01482715|FG001|Participant Flow|Rucaparib 80 mg QD (Part 1)|Rucaparib 80 mg once a day (QD) for continuous 21-day cycles
11082643|NCT01482715|FG002|Participant Flow|Rucaparib 160 mg QD (Part 1)|Rucaparib 160 mg once a day (QD) for continuous 21-day cycles
11082644|NCT01482715|FG003|Participant Flow|Rucaparib 300 mg QD (Part 1)|Rucaparib 300 mg once a day (QD) for continuous 21-day cycles
11082645|NCT01482715|FG004|Participant Flow|Rucaparib 500 mg QD (Part 1)|Rucaparib 500 mg once a day (QD) for continuous 21-day cycles
11082646|NCT01482715|FG005|Participant Flow|Rucaparib 240 mg BID (Part 1)|Rucaparib 240 mg twice a day (BID) for continuous 21-day cycles
11082647|NCT01482715|FG006|Participant Flow|Rucaparib 360 mg BID (Part 1)|Rucaparib 360 mg twice a day (BID) for continuous 21-day cycles
11082648|NCT01482715|FG007|Participant Flow|Rucaparib 480 mg BID (Part 1)|Rucaparib 480 mg twice a day (BID) for continuous 21-day cycles
11082649|NCT01482715|FG008|Participant Flow|Rucaparib 600 mg BID (Part 1)|Rucaparib 600 mg twice a day (BID) for continuous 21-day cycles
11082650|NCT01482715|FG009|Participant Flow|Rucaparib 840 mg BID (Part 1)|Rucaparib 840 mg twice a day (BID) for continuous 21-day cycles
11082651|NCT01482715|FG010|Participant Flow|Rucaparib 600 mg BID (Part 2A)|Rucaparib 600 mg twice a day (BID) for 21-day cycles
11082652|NCT01482715|FG011|Participant Flow|Rucaparib 600 mg BID (Part 2B)|Rucaparib 600 mg twice a day (BID) for 21-day cycles
11082653|NCT01482715|FG012|Participant Flow|Rucaparib 600 mg BID (Part 3)|Rucaparib 600 mg twice a day (BID) for 21-day cycles. Patients also received a single administration of 600 mg rucaparib on both Day -7 and Day 1 for assessing the effect of food on PK.
11082654|NCT01482715|OG000|Outcome|Rucaparib 600 mg BID (Part 2A)|Rucaparib 600 mg BID for 21-day cycles
11082655|NCT01482715|OG001|Outcome|Rucaparib 600 mg BID (Part 2B)|Rucaparib 600 mg BID for 21-day cycles
11082656|NCT01482715|OG000|Outcome|Rucaparib 40 mg QD (Part 1)|Rucaparib 40 mg once a day (QD)
11082657|NCT01482715|OG001|Outcome|Rucaparib 80 mg QD (Part 1)|Rucaparib 80 mg once a day (QD)
11082658|NCT01482715|OG002|Outcome|Rucaparib 160 mg QD (Part 1)|Rucaparib 160 mg once a day (QD)
11082659|NCT01482715|OG003|Outcome|Rucaparib 300 mg QD (Part 1)|Rucaparib 300 mg once a day (QD)
11082660|NCT01482715|OG004|Outcome|Rucaparib 500 mg QD (Part 1)|Rucaparib 500 mg once a day (QD)
11082661|NCT01482715|OG005|Outcome|Rucaparib 240 mg BID (Part 1)|Rucaparib 240 mg twice a day (BID)
11082662|NCT01482715|OG006|Outcome|Rucaparib 360 mg BID (Part 1)|Rucaparib 360 mg twice a day (BID)
11082663|NCT01482715|OG007|Outcome|Rucaparib 480 mg BID (Part 1)|Rucaparib 480 mg twice a day (BID)
11082664|NCT01482715|OG008|Outcome|Rucaparib 600 mg BID (Part 1)|Rucaparib 600 mg twice a day (BID)
11082665|NCT01482715|OG009|Outcome|Rucaparib 840 mg BID (Part 1)|Rucaparib 840 mg twice a day (BID)
11082666|NCT01482715|OG000|Outcome|Rucaparib 40 mg QD|Rucaparib 40 mg once a day (QD)
11082667|NCT01482715|OG001|Outcome|Rucaparib 80 mg QD|Rucaparib 80 mg once a day (QD)
11082668|NCT01482715|OG002|Outcome|Rucaparib 160 mg QD|Rucaparib 160 mg once a day (QD)
11082669|NCT01482715|OG003|Outcome|Rucaparib 300 mg QD|Rucaparib 300 mg once a day (QD)
11082670|NCT01482715|OG004|Outcome|Rucaparib 500 mg QD|Rucaparib 500 mg once a day (QD)
11082671|NCT01482715|OG005|Outcome|Rucaparib 240 mg BID|Rucaparib 240 mg twice a day (BID)
11082672|NCT01482715|OG006|Outcome|Rucaparib 360 mg BID|Rucaparib 360 mg twice a day (BID)
11082673|NCT01482715|OG007|Outcome|Rucaparib 480 mg BID|Rucaparib 480 mg twice a day (BID)
11082674|NCT01482715|OG008|Outcome|Rucaparib 600 mg BID|Rucaparib 600 mg twice a day (BID)
11082675|NCT01482715|OG009|Outcome|Rucaparib 840 mg BID|Rucaparib 840 mg twice a day (BID)
11082676|NCT01482715|OG000|Outcome|Rucaparib 600 mg BID (Part 2B)|Rucaparib 600 mg BID for 21-day cycles
11082677|NCT01482715|OG000|Outcome|Rucaparib 40 mg QD|Rucaparib 40 mg single dose
11082678|NCT01482715|OG001|Outcome|Rucaparib 300 mg QD|Rucaparib 300 mg single dose
11082679|NCT01482715|OG002|Outcome|Rucaparib 600 mg BID|Rucaparib 600 mg single dose
11082680|NCT01482715|EG000|Reported Event|Rucaparib 40 mg QD (Part 1)|Rucaparib 40 mg QD for 21-day cycles
11082681|NCT01482715|EG001|Reported Event|Rucaparib 80 mg QD (Part 1)|Rucaparib 80 mg QD for 21-day cycles
11082682|NCT01482715|EG002|Reported Event|Rucaparib 160 mg QD (Part 1)|Rucaparib 160 mg QD for 21-day cycles
11082683|NCT01482715|EG003|Reported Event|Rucaparib 300 mg QD (Part 1)|Rucaparib 300 mg QD for 21-day cycles
11082684|NCT01482715|EG004|Reported Event|Rucaparib 500 mg QD (Part 1)|Rucaparib 500 mg QD for 21-day cycles
11082685|NCT01482715|EG005|Reported Event|Rucaparib 240 mg BID (Part 1)|Rucaparib 240 mg BID for 21-day cycles
11082686|NCT01482715|EG006|Reported Event|Rucaparib 360 mg BID (Part 1)|Rucaparib 360 mg BID for 21-day cycles
11082687|NCT01482715|EG007|Reported Event|Rucaparib 480 mg BID (Part 1)|Rucaparib 480 mg BID for 21-day cycles
11082688|NCT01482715|EG008|Reported Event|Rucaparib 600 mg BID (Part 1)|Rucaparib 600 mg BID for 21-day cycles
11082689|NCT01482715|EG009|Reported Event|Rucaparib 840 mg BID (Part 1)|Rucaparib 840 mg BID for 21-day cycles
11082690|NCT01482715|EG010|Reported Event|Rucaparib 600 mg BID (Part 2A)|Rucaparib 600 mg BID for 21-day cycles
11082691|NCT01482715|EG011|Reported Event|Rucaparib 600 mg BID (Part 2B)|Rucaparib 600 mg BID for 21-day cycles
11082692|NCT01482715|EG012|Reported Event|Rucaparib 600 mg BID (Part 3)|Rucaparib 600 mg BID for 21-day cycles
11082693|NCT01482767|BG000|Baseline|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
11082694|NCT01482767|BG001|Baseline|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
11082695|NCT01482767|BG002|Baseline|Total|Total of all reporting groups
11082696|NCT01482767|FG000|Participant Flow|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
11227606|NCT02384200|OG000|Outcome|Antibiotic|"1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).~In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.~nitrofurantoin monohydrate/macrocrystalline capsules: 1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily~ampicillin: IV (2 g)~gentamicin: IV (5 mg/kg)~vancomycin: IV (1 g)~ceftriaxone: IV (2 g)"
11082697|NCT01482767|FG001|Participant Flow|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
11082698|NCT01482767|OG000|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
11082699|NCT01482767|OG001|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
11082700|NCT01482767|EG000|Reported Event|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
11082701|NCT01482767|EG001|Reported Event|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
11082702|NCT01482819|BG000|Baseline|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
11082703|NCT01482819|FG000|Participant Flow|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
11082704|NCT01482819|OG000|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
11082705|NCT01482819|OG001|Outcome|Galyfilcon A Plus|Test article
11082706|NCT01482819|OG002|Outcome|Galyfilcon A|test article
11082707|NCT01482819|OG003|Outcome|Lotrafilcon A|test article
11082708|NCT01482819|OG004|Outcome|Polymacon|test article
11082709|NCT01482819|EG000|Reported Event|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
11082710|NCT01482884|BG000|Baseline|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
11082711|NCT01482884|BG001|Baseline|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
11082712|NCT01482884|BG002|Baseline|Total|Total of all reporting groups
11082713|NCT01482884|FG000|Participant Flow|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
11082714|NCT01482884|FG001|Participant Flow|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
11082715|NCT01482884|OG000|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
11082716|NCT01482884|OG001|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
11082717|NCT01482884|EG000|Reported Event|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
11082718|NCT01482884|EG001|Reported Event|Tralokinumab 300 mg|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
11082719|NCT01482910|BG000|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
11082720|NCT01482910|BG001|Baseline|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
11082721|NCT01482910|BG002|Baseline|Total|Total of all reporting groups
11082722|NCT01482910|FG000|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
11082723|NCT01482910|FG001|Participant Flow|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
11082724|NCT01482910|OG000|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
11082725|NCT01482910|OG001|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
11082726|NCT01482910|EG000|Reported Event|Aflibercept Injection, up to Week 28|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data up to week 28 was reported.
11082727|NCT01482910|EG001|Reported Event|PDT Treatments, up to Week 28|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data up to week 28 was reported.
11082728|NCT01482910|EG002|Reported Event|Aflibercept Injection, From Week 28 to Week 52|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data from week 28 up to week 52 was reported.
11082729|NCT01482910|EG003|Reported Event|PDT Then Aflibercept Injection, From Week 28 to Week 52|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data from week 28 up to week 52 was reported.
11082730|NCT01482962|BG000|Baseline|Alisertib|Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
11082731|NCT01482962|BG001|Baseline|Pralatrexate, or Romidepsin, or Gemcitabine|Pralatrexate 30 mg/m^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
11082732|NCT01482962|BG002|Baseline|Total|Total of all reporting groups
11082733|NCT01482962|FG000|Participant Flow|Alisertib|Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
11082734|NCT01482962|FG001|Participant Flow|Pralatrexate, or Romidepsin, or Gemcitabine|Pralatrexate 30 mg/m^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
11082735|NCT01482962|OG000|Outcome|Alisertib|Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
11082736|NCT01482962|OG001|Outcome|Pralatrexate, or Romidepsin, or Gemcitabine|Pralatrexate 30 mg/m^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
11082737|NCT01482962|EG000|Reported Event|Alisertib|Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
11082738|NCT01482962|EG001|Reported Event|Gemcitabine|Gemcitabine 1,000 mg/m^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks).
11082739|NCT01482962|EG002|Reported Event|Pralatrexate|Pralatrexate 30 mg/m^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks).
11082740|NCT01482962|EG003|Reported Event|Romidepsin|Romidepsin 14 mg/m^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
11082741|NCT01483118|BG000|Baseline|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
11082742|NCT01483118|BG001|Baseline|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal."
11082743|NCT01483118|BG002|Baseline|Total|Total of all reporting groups
11082744|NCT01483118|FG000|Participant Flow|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
11082745|NCT01483118|FG001|Participant Flow|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal."
11082746|NCT01483118|OG000|Outcome|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.~Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23"
11082747|NCT01483118|OG001|Outcome|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal.~Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13"
11082748|NCT01483118|OG000|Outcome|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
11082749|NCT01483118|OG001|Outcome|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal."
11082750|NCT01483118|EG000|Reported Event|Cinnamon Extract Arm|"PCOS patients receiving extract of cinnamon~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
11082751|NCT01483118|EG001|Reported Event|Placebo Arm|"PCOS patients receiving placebo capsules~Placebo: Placebo capsules containing ground cereal."
11082752|NCT01483144|BG000|Baseline|Eflornithine Plus Sulindac|"Eflornithine 750 mg and Sulindac 150 mg~Eflornithine: Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]~Sulindac 150 MG: Sulindac [one tablet orally once a day]"
11082753|NCT01483144|BG001|Baseline|Eflornithine Plus Sulindac Placebo|"Eflornithine 750 mg and Placebo~Eflornithine: Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]~Sulindac placebo: Sulindac placebo [one tablet orally once a day]"
11082754|NCT01483144|BG002|Baseline|Sulindac Plus Eflornithine Placebo|"Sulindac 150 mg and Placebo~Eflornithine Placebo: Eflornithine placebo [three tablets orally once a day]~Sulindac 150 MG: Sulindac [one tablet orally once a day]"
11082755|NCT01483144|BG003|Baseline|Total|Total of all reporting groups
11082756|NCT01483144|FG000|Participant Flow|Eflornithine Plus Sulindac|"Eflornithine 750 mg and Sulindac 150 mg~Eflornithine: Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]~Sulindac 150 MG: Sulindac [one tablet orally once a day]"
11082757|NCT01483144|FG001|Participant Flow|Eflornithine Plus Sulindac Placebo|"Eflornithine 750 mg and Placebo~Eflornithine: Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]~Sulindac placebo: Sulindac placebo [one tablet orally once a day]"
11082758|NCT01483144|FG002|Participant Flow|Sulindac Plus Eflornithine Placebo|"Sulindac 150 mg and Placebo~Eflornithine Placebo: Eflornithine placebo [three tablets orally once a day]~Sulindac 150 MG: Sulindac [one tablet orally once a day]"
11082759|NCT01483144|OG000|Outcome|Eflornithine Plus Sulindac|"Eflornithine 750 mg and Sulindac 150 mg~Eflornithine: Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]~Sulindac 150 MG: Sulindac [one tablet orally once a day]"
11082760|NCT01483144|OG001|Outcome|Eflornithine Plus Sulindac Placebo|"Eflornithine 750 mg and Placebo~Eflornithine: Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]~Sulindac placebo: Sulindac placebo [one tablet orally once a day]"
11082761|NCT01483144|OG002|Outcome|Sulindac Plus Eflornithine Placebo|"Sulindac 150 mg and Placebo~Eflornithine Placebo: Eflornithine placebo [three tablets orally once a day]~Sulindac 150 MG: Sulindac [one tablet orally once a day]"
11082762|NCT01483144|EG000|Reported Event|Eflornithine Plus Sulindac|"Eflornithine 750 mg and Sulindac 150 mg~Eflornithine: Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]~Sulindac 150 MG: Sulindac [one tablet orally once a day]"
11082763|NCT01483144|EG001|Reported Event|Eflornithine Plus Sulindac Placebo|"Eflornithine 750 mg and Placebo~Eflornithine: Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]~Sulindac placebo: Sulindac placebo [one tablet orally once a day]"
11082764|NCT01483144|EG002|Reported Event|Sulindac Plus Eflornithine Placebo|"Sulindac 150 mg and Placebo~Eflornithine Placebo: Eflornithine placebo [three tablets orally once a day]~Sulindac 150 MG: Sulindac [one tablet orally once a day]"
11082765|NCT01483183|BG000|Baseline|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082766|NCT01483183|BG001|Baseline|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082767|NCT01483183|BG002|Baseline|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082768|NCT01483183|BG003|Baseline|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
11082769|NCT01483183|BG004|Baseline|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082770|NCT01483183|BG005|Baseline|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082771|NCT01483183|BG006|Baseline|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082772|NCT01483183|BG007|Baseline|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082773|NCT01483183|BG008|Baseline|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082774|NCT01483183|BG009|Baseline|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
11227607|NCT02384200|OG001|Outcome|No Preoperative Oral Antibiotics|"Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.~ampicillin: IV (2 g)~gentamicin: IV (5 mg/kg)~vancomycin: IV (1 g)~ceftriaxone: IV (2 g)"
11082775|NCT01483183|BG010|Baseline|Total|Total of all reporting groups
11082776|NCT01483183|FG000|Participant Flow|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants received a single dose of OPC-108459 0.26 milligram per kilogram (mg/kg), 10-minute constant rate intravenous (IV) infusion to achieve specified Cmax target.
11082777|NCT01483183|FG001|Participant Flow|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082778|NCT01483183|FG002|Participant Flow|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082779|NCT01483183|FG003|Participant Flow|Paroxysmal AF - Placebo|Participants received placebo dose 10-minute constant rate IV infusion.
11082780|NCT01483183|FG004|Participant Flow|Persistent AF - OPC-108459 0.26 mg/kg|Participants received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082781|NCT01483183|FG005|Participant Flow|Persistent AF - OPC-108459 0.40 mg/kg|Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082782|NCT01483183|FG006|Participant Flow|Persistent AF - OPC-108459 0.60 mg/kg|Participants received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082783|NCT01483183|FG007|Participant Flow|Persistent AF - OPC-108459 1.35 mg/kg|Participants received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082784|NCT01483183|FG008|Participant Flow|Persistent AF - OPC-108459 1.55 mg/kg|Participants received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082785|NCT01483183|FG009|Participant Flow|Persistent AF - Placebo|Participants received a single dose of placebo, 10-minute constant rate IV infusion.
11082786|NCT01483183|OG000|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082787|NCT01483183|OG001|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082788|NCT01483183|OG002|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082789|NCT01483183|OG003|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082790|NCT01483183|OG004|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082791|NCT01483183|OG005|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082792|NCT01483183|OG006|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082793|NCT01483183|OG007|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082794|NCT01483183|OG001|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082795|NCT01483183|OG003|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
11082796|NCT01483183|OG004|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082797|NCT01483183|OG005|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082798|NCT01483183|OG006|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082799|NCT01483183|OG007|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082800|NCT01483183|OG008|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082801|NCT01483183|OG009|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
11082802|NCT01483183|EG000|Reported Event|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082803|NCT01483183|EG001|Reported Event|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082804|NCT01483183|EG002|Reported Event|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082805|NCT01483183|EG003|Reported Event|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
11082806|NCT01483183|EG004|Reported Event|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082807|NCT01483183|EG005|Reported Event|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
11082808|NCT01483183|EG006|Reported Event|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082809|NCT01483183|EG007|Reported Event|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082810|NCT01483183|EG008|Reported Event|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
11082811|NCT01483183|EG009|Reported Event|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
11082812|NCT01483352|BG000|Baseline|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
11082813|NCT01483352|FG000|Participant Flow|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
11082814|NCT01483352|OG000|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
11082815|NCT01483352|EG000|Reported Event|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
11082816|NCT01483378|BG000|Baseline|Survey Participants|
11082817|NCT01483378|FG000|Participant Flow|Patients Who Received the Herpes Zoster Vaccine|These eligible subjects completed the survey and then chose to receive the herpes zoster vaccine for free.
11082818|NCT01483378|FG001|Participant Flow|Patients Who Declined the Herpes Zoster Vaccine|These eligible subjects completed the survey and then declined to receive the herpes zoster vaccine for free.
11082819|NCT01483378|OG000|Outcome|Patients Who Received the Herpes Zoster Vaccine|Patients who chose to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
11082820|NCT01483378|OG001|Outcome|Patients Who Declined the Herpes Zoster Vaccine|Patients who declined to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
11082821|NCT01483378|EG000|Reported Event|Subjects Who Received the Herpes Zoster Vaccine|
11082822|NCT01483378|EG001|Reported Event|Subjects Who Declined the Herpes Zoster Vaccine|
11082823|NCT01483560|BG000|Baseline|Metformin|"Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily~Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group"
11082824|NCT01483560|BG001|Baseline|Placebo|Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
11082825|NCT01483560|BG002|Baseline|Total|Total of all reporting groups
11082826|NCT01483560|FG000|Participant Flow|Metformin|"Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily~Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group"
11082827|NCT01483560|FG001|Participant Flow|Placebo|Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
11082828|NCT01483560|OG000|Outcome|Metformin|"Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily~Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group"
11082829|NCT01483560|OG001|Outcome|Placebo|Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
11082830|NCT01483560|EG000|Reported Event|Metformin|"Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily~Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group"
11082831|NCT01483560|EG001|Reported Event|Placebo|Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
11082832|NCT01483599|BG000|Baseline|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
11082833|NCT01483599|BG001|Baseline|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082834|NCT01483599|BG002|Baseline|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
11082835|NCT01483599|BG003|Baseline|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082836|NCT01483599|BG004|Baseline|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
11082837|NCT01483599|BG005|Baseline|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082838|NCT01483599|BG006|Baseline|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
11082839|NCT01483599|BG007|Baseline|Total|Total of all reporting groups
11082840|NCT01483599|FG000|Participant Flow|Placebo (CP)|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
11082841|NCT01483599|FG001|Participant Flow|CNTO1959 5 mg (CP)|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
11082842|NCT01483599|FG002|Participant Flow|CNTO1959 15 mg (CP)|Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
11082843|NCT01483599|FG003|Participant Flow|CNTO1959 50 mg (CP)|Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
11082844|NCT01483599|FG004|Participant Flow|CNTO1959 100 mg (CP)|Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
11082845|NCT01483599|FG005|Participant Flow|CNTO1959 200 mg (CP)|Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
11082846|NCT01483599|FG006|Participant Flow|Adalimumab (CP)|Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
11082847|NCT01483599|FG007|Participant Flow|Placebo -> 100 mg CNTO1959 (After CP)|Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
11082848|NCT01483599|FG008|Participant Flow|CNTO1959 5 mg (After CP)|Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
11082849|NCT01483599|FG009|Participant Flow|CNTO1959 15 mg (After CP)|Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
11082850|NCT01483599|FG010|Participant Flow|CNTO1959 50 mg (After CP)|Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
11082851|NCT01483599|FG011|Participant Flow|CNTO1959 100 mg (After CP)|Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
11082852|NCT01483599|FG012|Participant Flow|CNTO1959 200 mg (After CP)|Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
11082853|NCT01483599|FG013|Participant Flow|Adalimumab (After CP)|Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
11082854|NCT01483599|OG000|Outcome|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
11082855|NCT01483599|OG001|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082856|NCT01483599|OG002|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
11082857|NCT01483599|OG003|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082858|NCT01483599|OG004|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
11082859|NCT01483599|OG005|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082860|NCT01483599|OG006|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
11082861|NCT01483599|OG000|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082862|NCT01483599|OG001|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
11082863|NCT01483599|OG002|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082864|NCT01483599|OG003|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
11082865|NCT01483599|OG004|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
11082866|NCT01483599|OG005|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
11082867|NCT01483599|EG000|Reported Event|Placebo (CP)|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
11082868|NCT01483599|EG001|Reported Event|CNTO1959 5 mg (CP)|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
11082869|NCT01483599|EG002|Reported Event|CNTO1959 15 mg (CP)|Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
11082870|NCT01483599|EG003|Reported Event|CNTO1959 50 mg (CP)|Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
11082871|NCT01483599|EG004|Reported Event|CNTO1959 100 mg (CP)|Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
11082872|NCT01483599|EG005|Reported Event|CNTO1959 200 mg (CP)|Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
11082873|NCT01483599|EG006|Reported Event|Adalimumab (CP)|Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
11082874|NCT01483599|EG007|Reported Event|Placebo -> 100 mg CNTO1959 (After CP)|Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
11082875|NCT01483599|EG008|Reported Event|CNTO1959 5 mg (After CP)|Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
11082876|NCT01483599|EG009|Reported Event|CNTO1959 15 mg (After CP)|Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
11082877|NCT01483599|EG010|Reported Event|CNTO1959 50 mg (After CP)|Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
11082878|NCT01483599|EG011|Reported Event|CNTO1959 100 mg (After CP)|Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
11082879|NCT01483599|EG012|Reported Event|CNTO1959 200 mg (After CP)|Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
11082880|NCT01483599|EG013|Reported Event|Adalimumab (After CP)|Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
11082881|NCT01483625|BG000|Baseline|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
11082882|NCT01483625|BG001|Baseline|Tiotropium 18mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
11082883|NCT01483625|BG002|Baseline|Total|Total of all reporting groups
11082884|NCT01483625|FG000|Participant Flow|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
11082885|NCT01483625|FG001|Participant Flow|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
11082886|NCT01483625|OG000|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
11082887|NCT01483625|OG001|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
11082888|NCT01483625|EG000|Reported Event|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
11082889|NCT01483625|EG001|Reported Event|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
11082890|NCT01483651|BG000|Baseline|All Study Participants|Regular insulin given at each of three study visits with a different infusion rate at each visit, either low, medium or high insulin infusion with glucagon administration.
11082891|NCT01483651|FG000|Participant Flow|Low, Medium and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at lowest level with glucagon administration.~Second study is regular insulin infused at medium level with glucagon adminstration.~Third study is regular insulin infused at highest level with glucagon administration."
11082892|NCT01483651|FG001|Participant Flow|Low, High and Medium Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at lowest level with glucagon administration.~Second study is regular insulin infused at highest level with glucagon adminstration.~Third study is regular insulin infused at medium level with glucagon administration."
11082893|NCT01483651|FG002|Participant Flow|Medium, Low and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at medium level with glucagon administration.~Second study is regular insulin infused at lowest level with glucagon adminstration.~Third study is regular insulin infused at highest level with glucagon administration."
11082894|NCT01483651|FG003|Participant Flow|Medium, High and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at medium level with glucagon administration.~Second study is regular insulin infused at highest level with glucagon adminstration.~Third study is regular insulin infused at lowest level with glucagon administration."
11082895|NCT01483651|FG004|Participant Flow|High, Low and Medium Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at highest level with glucagon administration.~Second study is regular insulin infused at lowest level with glucagon adminstration.~Third study is regular insulin infused at medium level with glucagon administration."
11082896|NCT01483651|FG005|Participant Flow|High, Medium and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at highest level with glucagon administration.~Second study is regular insulin infused at medium level with glucagon adminstration.~Third study is regular insulin infused at lowest level with glucagon administration."
11082897|NCT01483651|OG000|Outcome|Low Insulin Infusion Rate|Regular insulin infused at lowest level of glucagon administration.
11082898|NCT01483651|OG001|Outcome|Medium Insulin Infusion Rate|Regular insulin infused at medium level with glucagon administration.
11082899|NCT01483651|OG002|Outcome|High Insulin Infusion Rate|Regular insulin infused at highest level with glucagon administration.
11082900|NCT01483651|EG000|Reported Event|Low Insulin Infusion|Regular insulin infused at lowest level with glucagon administration.
11082901|NCT01483651|EG001|Reported Event|Medium Insulin Infusion|Regular insulin infused at medium level with glucagon administration.
11082902|NCT01483651|EG002|Reported Event|High Insulin Infusion|regular insulin infused at highest level with glucagon administration.
11082903|NCT01483690|BG000|Baseline|Initial Dose Level|"Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21.~Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24"
11082904|NCT01483690|BG001|Baseline|Modified Dose Level|"Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19.~Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21"
11082905|NCT01483690|BG002|Baseline|Total|Total of all reporting groups
11082906|NCT01483690|FG000|Participant Flow|Initial Dose Level|"Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21.~Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24"
11082907|NCT01483690|FG001|Participant Flow|Modified Dose Level|"Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19.~Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21"
11082908|NCT01483690|OG000|Outcome|Initial Dose Level|"Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21.~Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24"
11082909|NCT01483690|OG001|Outcome|Modified Dose Level|"Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19.~Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21"
11082910|NCT01483690|EG000|Reported Event|Initial Dose Level|"Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21.~Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24"
11082911|NCT01483690|EG001|Reported Event|Modified Dose Level|"Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19.~Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21"
11082912|NCT01483807|BG000|Baseline|All Participants|All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a blocked fashion (SPT-B) first for 20 sessions. Following a 2 week washout period, those participants then received SPT applied in random fashion (SPT-R) for 20 sessions. The other half of the participants received the treatments in the opposite order.
11082913|NCT01483807|FG000|Participant Flow|SPT-B Then SPT-R|"Participants in this arm received Sound Production Treatment - Blocked (SPT-B) for 20 treatment sessions. Following a 2 week washout period, participants received Sound Production Treatment - Random (SPT-R) for 20 treatment sessions. SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation (watch me, listen to me, say it with me, articulation instruction, repeated practice and feedback. In the Blocked version, treatment targets are practiced by blocking items by sound target - words with the same target are grouped together. In the Random version, treatment targets are practiced in a non predictable order."
11082914|NCT01483807|FG001|Participant Flow|SPT-R Then SPT-B|"Participants in this arm received Sound Production Treatment - Random (SPT-R) for 20 treatment sessions. Following a 2 week washout period, participants received Sound Production Treatment - Blocked (SPT-B) for 20 treatment sessions. SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation (watch me, listen to me, say it with me, articulation instruction, repeated practice and feedback. In the Blocked version, treatment targets are practiced by blocking items by sound target - words with the same target are grouped together. In the Random version, treatment targets are practiced in a non predictable order."
11082915|NCT01483807|OG000|Outcome|SPT-R: All Participants|All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a blocked fashion (SPT-B) first for 20 sessions. Following a 2 week washout period, those participants then received SPT applied in random fashion (SPT-R) for 20 sessions. The other half of the participants received the treatments in the opposite order.All 20 administrations of SPT-R were analyzed relative to all 20 administrations of SPT-B.
11082916|NCT01483807|OG001|Outcome|SPT-B: All Participants|All 20 participants received both SPT-R and SPT-B, with order of administration of treatments being counterbalanced across participants. Data for SPT-B are shown here for all of the 20 participants.
11357472|NCT03757234|EG004|Reported Event|Levofloxacin 750 iv/750 po or iv|On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
11082917|NCT01483807|OG001|Outcome|SPT-B: All Participants|All participants received SPT-R and SPT-B with order of treatments counterbalanced. Response to SPT-B is shown here.
11082918|NCT01483807|OG001|Outcome|SPT-B: All Participants|All participants received both SPT-R and SPT-B with order of treatments counterbalanced. Results for SPT-B are shown here.
11357473|NCT03757039|BG000|Baseline|AOHG MF|All subjects randomized to AOHG MF
11357474|NCT03757039|BG001|Baseline|DT1 MF|All subjects randomized to DT1 MF
11082919|NCT01483807|OG001|Outcome|SPT-B: All Participants|All participants received both SPT-R and SPT-B with order of treatments counterbalanced. SPT-B results are shown here.
11082920|NCT01483807|EG000|Reported Event|All Participants|All participants received Sound Production Treatment (SPT). Half of the participants received SPT administered in a blocked fashion (SPT-B) first, followed by a 2 week washout period, and then SPT administered in a random fashion (SPT-R). The other half of the participants received both treatments administered in the reverse order. Participants were grouped together for analyses by treatment type; this was due to the fact that all participants received both treatments and were observed in the same way for both treatments regardless of which treatment was received first. There were not adverse events and consequently, no need to examine adverse events by arm.
11082921|NCT01483924|BG000|Baseline|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
11082922|NCT01483924|BG001|Baseline|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
11082923|NCT01483924|BG002|Baseline|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
11082924|NCT01483924|BG003|Baseline|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
11082925|NCT01483924|BG004|Baseline|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
11082926|NCT01483924|BG005|Baseline|Total|Total of all reporting groups
11092006|NCT01537042|EG000|Reported Event|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
11357475|NCT03757039|BG002|Baseline|DACP MF|All subjects randomized to DACP MF
11082927|NCT01483924|FG000|Participant Flow|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
11082928|NCT01483924|FG001|Participant Flow|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
11082929|NCT01483924|FG002|Participant Flow|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
11082930|NCT01483924|FG003|Participant Flow|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
11082931|NCT01483924|FG004|Participant Flow|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
11082932|NCT01483924|OG000|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
11082933|NCT01483924|OG001|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
11082934|NCT01483924|OG002|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
11082935|NCT01483924|OG003|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
11082936|NCT01483924|OG004|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
11082937|NCT01483924|OG000|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
11227608|NCT02384200|EG000|Reported Event|Antibiotic|"1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).~In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.~nitrofurantoin monohydrate/macrocrystalline capsules: 1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily~ampicillin: IV (2 g)~gentamicin: IV (5 mg/kg)~vancomycin: IV (1 g)~ceftriaxone: IV (2 g)"
11227609|NCT02384200|EG001|Reported Event|No Preoperative Oral Antibiotics|"Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.~ampicillin: IV (2 g)~gentamicin: IV (5 mg/kg)~vancomycin: IV (1 g)~ceftriaxone: IV (2 g)"
11082938|NCT01483924|OG001|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
11227610|NCT02384382|BG000|Baseline|Enzalutamide 160 mg (18F-NaF PET/CT)|Chemotherapy naive participants with progressive bone-metastatic CRPC were enrolled to receive enzalutamide 160 mg per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-NaF PET/CT was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
11233772|NCT02431260|BG003|Baseline|Part 1 / Treatment Group A: 30 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11082939|NCT01483924|OG002|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
11082940|NCT01483924|OG003|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
11082941|NCT01483924|OG000|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
11082942|NCT01483924|OG001|Outcome|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
11082943|NCT01483924|OG002|Outcome|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
11082944|NCT01483924|OG003|Outcome|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
11082945|NCT01483924|OG004|Outcome|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
11082946|NCT01483924|EG000|Reported Event|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
11082947|NCT01483924|EG001|Reported Event|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
11082948|NCT01483924|EG002|Reported Event|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
11082949|NCT01483924|EG003|Reported Event|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
11082950|NCT01483924|EG004|Reported Event|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
11082951|NCT01483937|BG000|Baseline|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
11082952|NCT01483937|BG001|Baseline|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
11082953|NCT01483937|BG002|Baseline|Total|Total of all reporting groups
11357476|NCT03757039|BG003|Baseline|PALs|All subjects assigned to PALs
11357477|NCT03757039|BG004|Baseline|Total|Total of all reporting groups
11082954|NCT01483937|FG000|Participant Flow|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
11082955|NCT01483937|FG001|Participant Flow|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
11082956|NCT01483937|OG000|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
11082957|NCT01483937|OG001|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
11082958|NCT01483937|OG000|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
11227611|NCT02384382|FG000|Participant Flow|Enzalutamide 160 Milligram (mg) (18F-NaF PET/CT)|Chemotherapy naive participants with progressive bone-metastatic castration-resistant prostate cancer (CRPC) were enrolled to receive enzalutamide 160 milligram (mg) per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-sodium fluoride positron-emission tomography/computed tomography bone imaging (18F-NaF PET/CT) was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
11227612|NCT02384382|OG000|Outcome|Enzalutamide 160 mg (18F-NaF PET/CT)|Chemotherapy naive participants with progressive bone-metastatic CRPC were enrolled to receive enzalutamide 160 mg per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-NaF PET/CT was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
11227613|NCT02384382|EG000|Reported Event|Enzalutamide 160 mg|Chemotherapy naive participants with progressive bone-metastatic CRPC were enrolled to receive enzalutamide 160 mg per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-NaF PET/CT was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
11082959|NCT01483937|OG001|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
11082960|NCT01483937|OG000|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received usual care physical therapy from vestibular and balance specialists."
11082961|NCT01483937|EG000|Reported Event|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
11082962|NCT01483937|EG001|Reported Event|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
11082963|NCT01483963|BG000|Baseline|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082964|NCT01483963|BG001|Baseline|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082965|NCT01483963|BG002|Baseline|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082966|NCT01483963|BG003|Baseline|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082967|NCT01483963|BG004|Baseline|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082968|NCT01483963|BG005|Baseline|Total|Total of all reporting groups
11227614|NCT02384395|BG000|Baseline|DTG/3TC/ABC FDC|Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
11227615|NCT02384395|FG000|Participant Flow|DTG/3TC/ABC FDC|Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
11082969|NCT01483963|FG000|Participant Flow|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082970|NCT01483963|FG001|Participant Flow|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082971|NCT01483963|FG002|Participant Flow|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082972|NCT01483963|FG003|Participant Flow|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082973|NCT01483963|FG004|Participant Flow|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082974|NCT01483963|OG000|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082975|NCT01483963|OG001|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082976|NCT01483963|OG002|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082977|NCT01483963|OG003|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11227616|NCT02384395|OG000|Outcome|DTG/3TC/ABC FDC|Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
11357478|NCT03757039|FG000|Participant Flow|Multifocal Contact Lenses|All subjects randomized to multifocal contact lenses (AOHG MF, DT1 MF, or DACP MF)
11227617|NCT02384395|EG000|Reported Event|DTG/3TC/ABC FDC|Dolutegravir (DTG 50 mg), abacavir sulfate (ABC 600 mg) and lamivudine (3TC 300 mg) formulated in a single tablet fixed dose combination (FDC) (DTG/ABC/3TC, GSK2619619), administered orally, once daily initiated during acute HIV infection.
11227618|NCT02384460|BG000|Baseline|SD-101-6.0 Cream|SD-101-6.0 cream applied topically, once a day to the entire body for a period of 90 days.
11227619|NCT02384460|BG001|Baseline|Placebo (SD-101-0.0) Cream|Placebo (SD-101-0.0) cream applied topically, once a day to the entire body for a period of 90 days.
11082978|NCT01483963|OG004|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082979|NCT01483963|OG000|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082980|NCT01483963|EG000|Reported Event|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082981|NCT01483963|EG001|Reported Event|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11227620|NCT02384460|BG002|Baseline|Total|Total of all reporting groups
11227621|NCT02384460|FG000|Participant Flow|SD-101-6.0 Cream|Participants applied SD-101-6.0 cream topically, once a day to the entire body for a period of 90 days.
11082982|NCT01483963|EG002|Reported Event|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082983|NCT01483963|EG003|Reported Event|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082984|NCT01483963|EG004|Reported Event|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
11082985|NCT01484028|BG000|Baseline|All Subjects|All randomized subjects who worn at least one pair of study lenses.
11082986|NCT01484028|FG000|Participant Flow|1DM/EADE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for dark eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
11082987|NCT01484028|FG001|Participant Flow|1DM/EALE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for light eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
11082988|NCT01484028|FG002|Participant Flow|EADE/1DM|etafilcon A for dark eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
11082989|NCT01484028|FG003|Participant Flow|EALE/1DM|etafilcon A for light eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
11082990|NCT01484028|OG000|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
11082991|NCT01484028|OG001|Outcome|1-DM|A marketed daily disposable contact lens to correct myopia.
11082992|NCT01484028|OG001|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia.
11082993|NCT01484028|OG001|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia, two were discontinued between the first and second periods.
11082994|NCT01484028|EG000|Reported Event|Etafilcon A With PVP for Dark/Light Eyes|A daily disposable contact lens to correct myopia.
11227622|NCT02384460|FG001|Participant Flow|Placebo (SD-101-0.0) Cream|Participants applied Placebo (SD-101-0.0) cream topically, once a day to the entire body for a period of 90 days.
11082995|NCT01484028|EG001|Reported Event|Etafilcon A Control Lenses|A marketed daily disposable contact lens to correct myopia.
11082996|NCT01484041|BG000|Baseline|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
11092007|NCT01537042|EG001|Reported Event|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
11092008|NCT01537068|BG000|Baseline|Desvenlafaxine|"SNRI antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
11227623|NCT02384460|OG000|Outcome|SD-101-6.0 Cream|Participants applied SD-101-6.0 cream topically, once a day to the entire body for a period of 90 days.
11227624|NCT02384460|OG001|Outcome|Placebo (SD-101-0.0) Cream|Participants applied Placebo (SD-101-0.0) cream topically, once a day to the entire body for a period of 90 days.
11227625|NCT02384460|EG000|Reported Event|SD-101-6.0 Cream|SD-101-6.0 cream applied topically, once a day to the entire body for a period of 90 days.
11227626|NCT02384460|EG001|Reported Event|Placebo (SD-101-0.0) Cream|Placebo (SD-101-0.0) cream applied topically, once a day to the entire body for a period of 90 days.
11227627|NCT02384538|BG000|Baseline|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
11227628|NCT02384538|BG001|Baseline|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
11227629|NCT02384538|BG002|Baseline|Total|Total of all reporting groups
11227630|NCT02384538|FG000|Participant Flow|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
11227631|NCT02384538|FG001|Participant Flow|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
11227632|NCT02384538|OG000|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
11227633|NCT02384538|OG001|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
11227634|NCT02384538|EG000|Reported Event|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
11227635|NCT02384538|EG001|Reported Event|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
11227636|NCT02384941|BG000|Baseline|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
11227637|NCT02384941|BG001|Baseline|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
11227638|NCT02384941|BG002|Baseline|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
11082997|NCT01484041|FG000|Participant Flow|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
11082998|NCT01484041|OG000|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
11082999|NCT01484041|EG000|Reported Event|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
11083000|NCT01484054|BG000|Baseline|All Subjects|All enrolled subjects who received study lenses.
11083001|NCT01484054|FG000|Participant Flow|EAPVPDE/EADE|etafilcon A with embedded print and PVP for dark eyes lens worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
11083002|NCT01484054|FG001|Participant Flow|EADE/EAPVPDE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
11083003|NCT01484054|OG000|Outcome|EAPVPDE|A daily disposable contact lens.
11083004|NCT01484054|OG001|Outcome|EADE|A marketed daily disposable contact lens
11083005|NCT01484054|OG000|Outcome|EAPVPDE|A daily disposable contact lens
11083006|NCT01484054|EG000|Reported Event|EAPVPDE|etafilcon A material incorporating PVP in the blister packaging solution.
11083007|NCT01484054|EG001|Reported Event|EADE|etafilcon a existing, daily disposable contact lens.
11083008|NCT01484132|BG000|Baseline|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
11083009|NCT01484132|FG000|Participant Flow|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
11083010|NCT01484132|OG000|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
11083011|NCT01484132|EG000|Reported Event|Composite|Restoration of dental caries with dental composite: Dental Resin Restoration (bisphenol A diglycidyl ether methacrylate based composite)
11083012|NCT01484197|BG000|Baseline|All Participants|All participants randomized to one of four treatment sequences.
11083013|NCT01484197|FG000|Participant Flow|Sequence 1|Treatment Period 1: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
11083014|NCT01484197|FG001|Participant Flow|Sequence 2|Treatment Period 1: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM ) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
11083015|NCT01484197|FG002|Participant Flow|Sequence 3|Treatment Period 1: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
11092009|NCT01537068|BG001|Baseline|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
11357479|NCT03757039|FG001|Participant Flow|PAL Spectacles Wearers|All subjects assigned to progressive addition lens (PAL) spectacles
11092010|NCT01537068|BG002|Baseline|Total|Total of all reporting groups
11092011|NCT01537068|FG000|Participant Flow|Desvenlafaxine|"Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
11092012|NCT01537068|FG001|Participant Flow|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
11357480|NCT03757039|OG000|Outcome|Multifocal Contact Lenses|Multifocal soft contact lenses (AOHG MF, DACP MF, DT1 MF combined) according to the subject's prescription and fitted using the Alcon multifocal fitting guide. Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only.
11083016|NCT01484197|FG003|Participant Flow|Sequence 4|Treatment Period 1: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
11083017|NCT01484197|OG000|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
11083018|NCT01484197|OG001|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
11083019|NCT01484197|OG002|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
11083020|NCT01484197|OG003|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
11083021|NCT01484197|EG000|Reported Event|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
11083022|NCT01484197|EG001|Reported Event|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
11083023|NCT01484197|EG002|Reported Event|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
11083024|NCT01484197|EG003|Reported Event|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
11227639|NCT02384941|BG003|Baseline|Total|Total of all reporting groups
11083025|NCT01484275|BG000|Baseline|Siltuximab|Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
11083026|NCT01484275|BG001|Baseline|Placebo|Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
11083027|NCT01484275|BG002|Baseline|Total|Total of all reporting groups
11083028|NCT01484275|FG000|Participant Flow|Siltuximab|Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
11083029|NCT01484275|FG001|Participant Flow|Placebo|Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
11083030|NCT01484275|OG000|Outcome|Siltuximab|Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
11227640|NCT02384941|FG000|Participant Flow|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
11083031|NCT01484275|OG001|Outcome|Placebo|Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
11083032|NCT01484275|EG000|Reported Event|Siltuximab|Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
11083033|NCT01484275|EG001|Reported Event|Placebo|Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
11083034|NCT01484288|BG000|Baseline|Device Group|"Barostim Neo system~Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System"
11083035|NCT01484288|FG000|Participant Flow|Device Group|"Barostim Neo system~Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System"
11083036|NCT01484288|OG000|Outcome|Device Group|"Barostim Neo system~Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System"
11083037|NCT01484288|EG000|Reported Event|Device Group|"Barostim Neo system~Barostim Neo System: Baroreflex Activation Therapy using the Barostim Neo System"
11083038|NCT01484340|BG000|Baseline|Counseling Only|"Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).~Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
11092013|NCT01537068|OG000|Outcome|Desvenlafaxine|"SNRI antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
11092014|NCT01537068|OG001|Outcome|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
11092015|NCT01537068|EG000|Reported Event|Desvenlafaxine|"SNRI antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
11227641|NCT02384941|FG001|Participant Flow|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
11083039|NCT01484340|BG001|Baseline|Nicotine Replacement Therapy +Counseling|"Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).~Nicotine: The nicotine patch be given in three phases:~2 weeks of patches at enrollment~6 weeks of patches at two-week follow-up visit~2 weeks of patches at two-month follow-up visit~Intensive Counseling: same as in Counseling only arm~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
11083040|NCT01484340|BG002|Baseline|Total|Total of all reporting groups
11083041|NCT01484340|FG000|Participant Flow|Counseling Only|"Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).~Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
11083042|NCT01484340|FG001|Participant Flow|Nicotine Replacement Therapy +Counseling|"Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).~Nicotine: The nicotine patch be given in three phases:~2 weeks of patches at enrollment~6 weeks of patches at two-week follow-up visit~2 weeks of patches at two-month follow-up visit~Intensive Counseling: same as in Counseling only arm~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
11083043|NCT01484340|OG000|Outcome|Counseling Only|"Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).~Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
11083044|NCT01484340|OG001|Outcome|Nicotine Replacement Therapy +Counseling|"Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).~Nicotine: The nicotine patch be given in three phases:~2 weeks of patches at enrollment~6 weeks of patches at two-week follow-up visit~2 weeks of patches at two-month follow-up visit~Intensive Counseling: same as in Counseling only arm~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
11083045|NCT01484340|EG000|Reported Event|Counseling Only|"Participants in this arm will receive advice to quit smoking and self-help materials from the study interventionist in a standardized fashion (intensive anti-smoking counseling).~Intensive Counseling: The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
11083046|NCT01484340|EG001|Reported Event|Nicotine Replacement Therapy +Counseling|"Participants in this arm will receive the nicotine patch in addition to the intensive anti-smoking counseling. Participants will receive instruction on proper use of the nicotine patch (i.e., placement, use of one patch a day, importance of not smoking while using the patch, and tapering of patches).~Nicotine: The nicotine patch be given in three phases:~2 weeks of patches at enrollment~6 weeks of patches at two-week follow-up visit~2 weeks of patches at two-month follow-up visit~Intensive Counseling: same as in Counseling only arm~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
11083047|NCT01484431|BG000|Baseline|Light Weight: <25 kg|Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.
11083048|NCT01484431|BG001|Baseline|Middle Weight: 25 kg to <40 kg|Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.
11083049|NCT01484431|BG002|Baseline|Heavy Weight: ≥40 kg|Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.
11083050|NCT01484431|BG003|Baseline|Total|Total of all reporting groups
11083051|NCT01484431|FG000|Participant Flow|Light Weight <25 kg|"Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.~Period 2: Open Label Extension for 2 years.~7 mg, 8 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral suspension formulation."
11083052|NCT01484431|FG001|Participant Flow|Middle Weight: 25 kg to <40 kg|"Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.~Period 2: Open Label Extension for 2 years.~7.5 mg, 10 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral tablet."
11092016|NCT01537068|EG001|Reported Event|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
11227642|NCT02384941|FG002|Participant Flow|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
11083053|NCT01484431|FG002|Participant Flow|Heavy Weight: ≥40 kg|"Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.~Period 2: Open Label Extension for 2 years.~15 mg, 20 mg or 40 mg tadalafil administered once daily (QD) in oral tablet."
11083054|NCT01484431|OG000|Outcome|20 mg Light Weight: <25 kg|20 mg tadalafil administered QD in oral suspension formulation.
11083055|NCT01484431|OG001|Outcome|20 mg Middle Weight: 25 kg to <40 kg|20 mg tablet tadalafil administered QD.
11083056|NCT01484431|OG002|Outcome|40 mg Heavy Weight: ≥40 kg|40 mg tablet tadalafil administered QD.
11083057|NCT01484431|OG000|Outcome|20 mg Light Weight <25 kg|20 mg tadalafil administered QD in oral suspension formulation.
11083058|NCT01484431|OG000|Outcome|Light Weight <25 kg|"Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.~Period 2: Open Label Extension for 2 years.~7 mg, 8 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral suspension formulation."
11083059|NCT01484431|OG001|Outcome|Middle Weight: 25 kg to <40 kg|"Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.~Period 2: Open Label Extension for 2 years.~7.5 mg, 10 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral tablet."
11083060|NCT01484431|OG002|Outcome|Heavy Weight: ≥40 kg|"Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.~Period 2: Open Label Extension for 2 years.~15 mg, 20 mg or 40 mg tadalafil administered once daily (QD) in oral tablet."
11083061|NCT01484431|OG000|Outcome|Light Weight: <25 kg|Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.
11083062|NCT01484431|EG000|Reported Event|Light Weight: <25 kg|"Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.~Period 2: Open Label Extension for 2 years.~7 mg, 8 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral suspension formulation."
11083063|NCT01484431|EG001|Reported Event|Middle Weight: 25 kg to <40 kg|"Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.~Period 2: Open Label Extension for 2 years.~7.5 mg, 10 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral tablet.~."
11150518|NCT01877551|FG000|Participant Flow|Tauroursodeoxycholic Acid|"This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.~Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days."
11150519|NCT01877551|FG001|Participant Flow|Placebo|"This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.~Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days."
11150520|NCT01877551|OG000|Outcome|Tauroursodeoxycholic Acid|"This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.~Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days."
11150521|NCT01877551|OG001|Outcome|Placebo|"This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.~Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days."
11150522|NCT01877551|EG000|Reported Event|Tauroursodeoxycholic Acid|"This group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.~Tauroursodeoxycholic acid: The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days."
11150523|NCT01877551|EG001|Reported Event|Placebo|"This group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.~Placebo tablet: The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days."
11150524|NCT01877642|BG000|Baseline|Open Label Subjects|Open label portion of study
11150525|NCT01877642|BG001|Baseline|All Crossover Subjects|All 6 crossover treatment sequences
11150526|NCT01877642|BG002|Baseline|Total|Total of all reporting groups
11150527|NCT01877642|FG000|Participant Flow|Open Label (Lorazepam 1 mg + Inhaled Loxapine 10 mg)|"Inhaled Staccato loxapine 10 mg + IM lorazepam 1 mg~Lorazepam 1 mg IM: Lorazepam 1 mg intramuscular~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg"
11150528|NCT01877642|FG001|Participant Flow|Treatment Sequence ABC|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
11150529|NCT01877642|FG002|Participant Flow|Treatment Sequence ACB|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
11150530|NCT01877642|FG003|Participant Flow|Treatment Sequence BCA|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
11150531|NCT01877642|FG004|Participant Flow|Treatment Sequence BAC|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
11150532|NCT01877642|FG005|Participant Flow|Treatment Sequence CAB|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
11150533|NCT01877642|FG006|Participant Flow|Treatment Sequence CBA|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
11150534|NCT01877642|OG000|Outcome|Open Label Group|Lorazepam 1 mg IM + Inhaled loxapine 10 mg
11150535|NCT01877642|OG000|Outcome|Lorazepam+Loxapine / Lorazepam|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Lorazepam 1 mg IM
11083064|NCT01484431|EG002|Reported Event|Heavy Weight: ≥40 kg|"Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.~Period 2: Open Label Extension for 2 years.~15 mg, 20 mg or 40 mg tadalafil administered once daily (QD) in oral tablet."
11083065|NCT01484496|BG000|Baseline|Placebo SC|Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
11083066|NCT01484496|BG001|Baseline|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
11083067|NCT01484496|BG002|Baseline|Total|Total of all reporting groups
11083068|NCT01484496|FG000|Participant Flow|Placebo SC|Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
11083069|NCT01484496|FG001|Participant Flow|Belimumab 200 mg SC|Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
11083070|NCT01484496|FG002|Participant Flow|Open-Label - Placebo SC to Belimumab 200 mg SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
11083071|NCT01484496|FG003|Participant Flow|Open-Label - Belimumab 200 SC to Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly
11083072|NCT01484496|OG000|Outcome|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
11083073|NCT01484496|OG001|Outcome|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
11083074|NCT01484496|EG000|Reported Event|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
11083075|NCT01484496|EG001|Reported Event|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
11083076|NCT01484496|EG002|Reported Event|Open-Label - Placebo SC to Belimumab 200 mg SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
11083077|NCT01484496|EG003|Reported Event|Open-Label - Belimumab 200 SC to Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
11083078|NCT01484561|BG000|Baseline|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
11083079|NCT01484561|BG001|Baseline|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
11083080|NCT01484561|BG002|Baseline|Total|Total of all reporting groups
11083081|NCT01484561|FG000|Participant Flow|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
11083082|NCT01484561|FG001|Participant Flow|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
11083083|NCT01484561|OG000|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
11083084|NCT01484561|OG001|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
11083085|NCT01484561|EG000|Reported Event|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
11150536|NCT01877642|OG001|Outcome|Lorazepam+Loxapine / Loxapine|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Inhaled Loxapine 10 mg
11150537|NCT01877642|EG000|Reported Event|Open Label (Lorazepam 1 mg + Inhaled Loxapine 10 mg)|"Inhaled Staccato loxapine 10 mg + IM lorazepam 1 mg~Lorazepam 1 mg IM: Lorazepam 1 mg intramuscular~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg"
11150538|NCT01877642|EG001|Reported Event|Lorazepam 1 mg IM|"Lorazepam 1 mg IM + Inhaled placebo~Lorazepam 1 mg IM: Lorazepam 1 mg intramuscular~Inhaled Placebo: Inhaler with no drug in it to mimic the ADASUVE inhaler"
11150539|NCT01877642|EG002|Reported Event|Lorazepam 1 mg IM + Inhaled Loxapine 10 mg|"Lorazepam 1 mg IM + Inhaled Staccato loxapine 10 mg~Lorazepam 1 mg IM: Lorazepam 1 mg intramuscular~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg"
11083086|NCT01484561|EG001|Reported Event|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
11083087|NCT01484626|BG000|Baseline|Bendamustine|Bendamustine is combined with standard chemotherapy
11083088|NCT01484626|FG000|Participant Flow|Bendamustine|Bendamustine is combined with standard chemotherapy
11083089|NCT01484626|OG000|Outcome|Bendamustine|Bendamustine is combined with standard chemotherapy
11083090|NCT01484626|EG000|Reported Event|Bendamustine|Bendamustine is combined with standard chemotherapy
11083091|NCT01484652|BG000|Baseline|COV795|2 tablets taken every 12 hours
11083092|NCT01484652|BG001|Baseline|Placebo|2 tablets taken every 12 hours
11083093|NCT01484652|BG002|Baseline|Total|Total of all reporting groups
11083094|NCT01484652|FG000|Participant Flow|COV795|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
11083095|NCT01484652|FG001|Participant Flow|Placebo|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
11227643|NCT02384941|OG000|Outcome|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
11083096|NCT01484652|OG000|Outcome|COV795|2 tablets taken every 12 hours
11083097|NCT01484652|OG001|Outcome|Placebo|2 tablets taken every 12 hours
11083098|NCT01484652|EG000|Reported Event|COV795|2 tablets taken every 12 hours
11083099|NCT01484652|EG001|Reported Event|Placebo|2 tablets taken every 12 hours
11083100|NCT01484834|BG000|Baseline|Exercise in the Workplace and Educational Intervention|Participants received exercise in the workplace and educational intervention
11083101|NCT01484834|BG001|Baseline|Exercise in the Workplace|Participants received exercise only
11083102|NCT01484834|BG002|Baseline|Educational Intervention|Participants received educational intervention only
11083103|NCT01484834|BG003|Baseline|Control Company|Participants did not receive any intervention
11083104|NCT01484834|BG004|Baseline|Total|Total of all reporting groups
11083105|NCT01484834|FG000|Participant Flow|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11083106|NCT01484834|FG001|Participant Flow|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11083107|NCT01484834|FG002|Participant Flow|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11083108|NCT01484834|FG003|Participant Flow|Control Company|No intervention. Control group received no intervention during study period
11083109|NCT01484834|OG000|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11083110|NCT01484834|OG001|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11083111|NCT01484834|OG002|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11083112|NCT01484834|OG003|Outcome|Control Company|No intervention. Control group received no intervention during study period
11083113|NCT01484834|EG000|Reported Event|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11227644|NCT02384941|OG001|Outcome|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
11083114|NCT01484834|EG001|Reported Event|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11083115|NCT01484834|EG002|Reported Event|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
11083116|NCT01484834|EG003|Reported Event|Control Company|No intervention. Control group received no intervention during study period
11083117|NCT01484873|BG000|Baseline|Exenatide|exenatide 10 mcg twice daily
11083118|NCT01484873|FG000|Participant Flow|Exenatide|exenatide 10 mcg twice daily
11083119|NCT01484873|OG000|Outcome|Exenatide|exenatide 10 mcg twice daily
11083120|NCT01484873|OG000|Outcome|Exenatide|Exenatide: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
11083121|NCT01484873|EG000|Reported Event|Exenatide|exenatide 10 mcg twice daily
11083122|NCT01484912|BG000|Baseline|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
11083123|NCT01484912|BG001|Baseline|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
11083124|NCT01484912|BG002|Baseline|Total|Total of all reporting groups
11083125|NCT01484912|FG000|Participant Flow|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
11083126|NCT01484912|FG001|Participant Flow|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
11083127|NCT01484912|OG000|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
11083128|NCT01484912|OG001|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
11083129|NCT01484912|EG000|Reported Event|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
11083130|NCT01484912|EG001|Reported Event|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
11083131|NCT01484938|BG000|Baseline|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
11083132|NCT01484938|FG000|Participant Flow|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
11083133|NCT01484938|OG000|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
11083134|NCT01484938|EG000|Reported Event|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
11083135|NCT01484951|BG000|Baseline|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
11083136|NCT01484951|FG000|Participant Flow|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
11083137|NCT01484951|OG000|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
11083138|NCT01484951|EG000|Reported Event|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
11083139|NCT01484977|BG000|Baseline|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
11083140|NCT01484977|FG000|Participant Flow|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
11083141|NCT01484977|OG000|Outcome|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
11083142|NCT01484977|EG000|Reported Event|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
11150540|NCT01877642|EG003|Reported Event|Inhaled Loxapine 10 mg|"Inhaled Staccato loxapine 10 mg + IM placebo~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg~Placebo IM: intramuscular placebo to mimic lorazepam 1 mg IM"
11150541|NCT01877668|BG000|Baseline|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
11150542|NCT01877668|BG001|Baseline|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
11150543|NCT01877668|BG002|Baseline|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
11150544|NCT01877668|BG003|Baseline|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
11150545|NCT01877668|BG004|Baseline|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
11150546|NCT01877668|BG005|Baseline|Total|Total of all reporting groups
11150547|NCT01877668|FG000|Participant Flow|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
11083143|NCT01485055|BG000|Baseline|Infliximab and Basiliximab|"Other Names:~Simulect Remicade Monoclonal antibody~Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.~Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times.~Infliximab and Basiliximab: Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks."
11083144|NCT01485055|FG000|Participant Flow|Infliximab and Basiliximab|"Other Names:~Simulect Remicade Monoclonal antibody~Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.~Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times.~Infliximab and Basiliximab: Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks."
11083145|NCT01485055|OG000|Outcome|Infliximab and Basiliximab|"Other Names:~Simulect Remicade Monoclonal antibody~Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.~Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times.~Infliximab and Basiliximab: Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks."
11083146|NCT01485055|EG000|Reported Event|Infliximab and Basiliximab|"Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.~Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times."
11083147|NCT01485094|BG000|Baseline|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
11083148|NCT01485094|BG001|Baseline|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~GRT6010: Oral solution given once daily."
11083149|NCT01485094|BG002|Baseline|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
11083150|NCT01485094|BG003|Baseline|Total|Total of all reporting groups
11083151|NCT01485094|FG000|Participant Flow|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo: Matching Placebo capsules to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
11083152|NCT01485094|FG001|Participant Flow|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~GRT6010: Oral solution given once daily."
11083153|NCT01485094|FG002|Participant Flow|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
11083154|NCT01485094|OG000|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
11083155|NCT01485094|OG001|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
11083156|NCT01485094|OG002|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
11083157|NCT01485094|EG000|Reported Event|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~Matching Placebo: Matching Placebo capsules to the Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
11083158|NCT01485094|EG001|Reported Event|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
11083159|NCT01485094|EG002|Reported Event|Pregabalin|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~Pregabalin: Pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
11083160|NCT01485120|BG000|Baseline|Blood Pressure Monitoring|Blood Pressure Monitoring using two methods: invasive radial line insertion and non-invasive blood pressure cuff
11227645|NCT02384941|OG002|Outcome|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
11227646|NCT02384941|OG000|Outcome|Placebo|Two placebo-matching sotagliflozin tables, once daily, orally for 24 weeks followed by a 28 week extension period.
11083161|NCT01485120|FG000|Participant Flow|Blood Pressure Monitoring|"Participants with blood pressure monitored using invasive and non-invasive methods. Blood pressure monitoring will take place with both devices simultaneously. The invasive gold standard device is a radial arterial catheter connected to the DASH 4000, while the non-invasive device is the Soft-Cuf connected to the DASH 4000 Patient Bedside Monitor with SuperSTAT NIBP software, or same with the Classic NIBP algorithm."
11083162|NCT01485120|OG000|Outcome|Blood Pressure Monitoring|Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used either the SuperSTAT NIBP algorithm and the Classic NIBP algorithm for output.
11083163|NCT01485120|OG000|Outcome|Blood Pressure Monitoring|Participants with blood pressure monitored using invasive and non-invasive methods.
11083164|NCT01485120|EG000|Reported Event|Blood Pressure Monitoring|All participants enrolled in the study
11083165|NCT01485172|BG000|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083166|NCT01485172|BG001|Baseline|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083167|NCT01485172|BG002|Baseline|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083168|NCT01485172|BG003|Baseline|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083169|NCT01485172|BG004|Baseline|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083170|NCT01485172|BG005|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083171|NCT01485172|BG006|Baseline|Total|Total of all reporting groups
11083172|NCT01485172|FG000|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083173|NCT01485172|FG001|Participant Flow|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083174|NCT01485172|FG002|Participant Flow|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083175|NCT01485172|FG003|Participant Flow|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083176|NCT01485172|FG004|Participant Flow|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083177|NCT01485172|FG005|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083178|NCT01485172|OG000|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
11227647|NCT02384941|EG000|Reported Event|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
11227648|NCT02384941|EG001|Reported Event|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
11227649|NCT02384941|EG002|Reported Event|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
11227650|NCT02385084|BG000|Baseline|LY2409021 (Part A)|20 mg LY2409021 administered as capsules, T2, or T3 once, orally in each of 3 study periods.
11083179|NCT01485172|OG001|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083180|NCT01485172|OG002|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11227651|NCT02385084|FG000|Participant Flow|LY2409021 Capsules/T2/T3 (Part A)|"Period 1: 20 milligrams (mg) LY2409021 administered as capsules once, orally.~Period 2: 20 mg LY2409021 administered as a pre-commercial tablet (T2) once, orally.~Period 3: 20 mg LY2409021 administered as a commercial tablet (T3) once, orally.~There were at least 15 days between doses of study drug (washout)."
11227652|NCT02385084|FG001|Participant Flow|LY2409021 T2/Capsules/T3 (Part A)|"Period 1: 20 mg LY2409021 administered as T2 once, orally.~Period 2: 20 mg LY2409021 administered as capsules once, orally.~Period 3: 20 mg LY2409021 administered as T3 once, orally.~There were at least 15 days between doses of study drug (washout)."
11227653|NCT02385084|FG002|Participant Flow|LY2409021 T3/T2/Capsules (Part A)|"Period 1: 20 mg LY2409021 administered as T3 once, orally.~Period 2: 20 mg LY2409021 administered as T2 once, orally.~Period 3: 20 mg LY2409021 administered as capsules once, orally.~There were at least 15 days between doses of study drug (washout)."
11227654|NCT02385084|FG003|Participant Flow|LY2409021 T3/Capsules/T2 (Part A)|"Period 1: 20 mg LY2409021 administered as T3 once, orally.~Period 2: 20 mg LY2409021 administered as capsules once, orally.~Period 3: 20 mg LY2409021 administered as T2 once, orally.~There were at least 15 days between doses of study drug (washout)."
11227655|NCT02385084|FG004|Participant Flow|LY2409021 T2/T3/Capsules (Part A)|"Period 1: 20 mg LY2409021 administered as T2 once, orally.~Period 2: 20 mg LY2409021 administered as T3 once, orally.~Period 3: 20 mg LY2409021 administered as capsules once, orally.~There were at least 15 days between doses of study drug (washout)."
11227656|NCT02385084|FG005|Participant Flow|LY2409021 Capsules/T3/T2 (Part A)|"Period 1: 20 mg LY2409021 administered as capsules once, orally.~Period 2: 20 mg LY2409021 administered as T3 once, orally.~Period 3: 20 mg LY2409021 administered as T2 once, orally.~There were at least 15 days between doses of study drug (washout)."
11083181|NCT01485172|OG003|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11227657|NCT02385084|OG000|Outcome|LY2409021 Capsules (Part A)|20 mg LY2409021 administered as capsules once, orally in 1 of 3 study periods.
11227658|NCT02385084|OG001|Outcome|LY2409021 T2 (Part A)|20 mg LY2409021 administered as T2 once, orally in 1 of 3 study periods.
11227659|NCT02385084|OG002|Outcome|LY2409021 T3 (Part A)|20 mg LY2409021 T3 administered once, orally in 1 of 3 study periods.
11227660|NCT02385084|OG002|Outcome|LY2409021 T3 (Part A)|20 mg LY2409021 administered as T3 once, orally in 1 of 3 study periods.
11227661|NCT02385084|EG000|Reported Event|LY2409021 Capsules (Part A)|20 mg LY2409021 administered as capsules once, orally in 1 of 3 study periods.
11227662|NCT02385084|EG001|Reported Event|LY2409021 T2 (Part A)|20 mg LY2409021 administered as T2 once, orally in 1 of 3 study periods.
11227663|NCT02385084|EG002|Reported Event|LY2409021 T3 (Part A)|20 mg LY2409021 administered as T3 once, orally in 1 of 3 study periods.
11227664|NCT02385097|BG000|Baseline|Chloroprocaine HCl 2% (20 mg/mL)|"Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL~Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route"
11227665|NCT02385097|BG001|Baseline|Ropivacaine 0.75% (7.5 mg/mL)|"Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL~Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route"
11227666|NCT02385097|BG002|Baseline|Total|Total of all reporting groups
11227667|NCT02385097|FG000|Participant Flow|Chloroprocaine HCl 2% (20 mg/mL)|"Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL~Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route"
11227668|NCT02385097|FG001|Participant Flow|Ropivacaine 0.75% (7.5 mg/mL)|"Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL~Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route"
11227669|NCT02385097|OG000|Outcome|Chloroprocaine HCl 2% (20 mg/mL)|"Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL~Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route"
11357481|NCT03757039|OG001|Outcome|PAL Spectacles|Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
11083182|NCT01485172|OG004|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083183|NCT01485172|OG005|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083184|NCT01485172|EG000|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083185|NCT01485172|EG001|Reported Event|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083186|NCT01485172|EG002|Reported Event|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083187|NCT01485172|EG003|Reported Event|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083188|NCT01485172|EG004|Reported Event|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083189|NCT01485172|EG005|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
11083190|NCT01485354|BG000|Baseline|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
11357482|NCT03757039|EG000|Reported Event|AOHG MF|All subjects exposed to AOHG MF
11083191|NCT01485354|FG000|Participant Flow|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
11083192|NCT01485354|OG000|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
11083193|NCT01485354|EG000|Reported Event|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
11083194|NCT01485380|BG000|Baseline|Active Study Arm|"Subjects recruited into this study will be required to undergo two MRI-PET scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
11083195|NCT01485380|FG000|Participant Flow|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
11150548|NCT01877668|FG001|Participant Flow|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
11150549|NCT01877668|FG002|Participant Flow|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
11150550|NCT01877668|FG003|Participant Flow|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
11083196|NCT01485380|OG000|Outcome|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss on consciousness is initially observed. Loss on consciousness will be assayed by specific auditory and verbal stimuli."
11083197|NCT01485380|EG000|Reported Event|Active Study Arm|"Subjects recruited into this study will be required to undergo two MR-PET scans of the brain in addition to high density EEG acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
11083198|NCT01485393|BG000|Baseline|All Study Participants|All study participants who were either randomized to receive either Dexmedetomidine or Zolpidem initially.
11083199|NCT01485393|FG000|Participant Flow|Healthy Control Subjects: Zolpidem, Then Dexmedetomidine|This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep.
11083200|NCT01485393|FG001|Participant Flow|Healthy Control Subjects: Dexmedetomidine, Then Zolpidem|This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep.
11083201|NCT01485393|OG000|Outcome|Zolpidem-Induced Sleep|All healthy control subjects undergo a night of zolpidem-induced sleep.
11083202|NCT01485393|OG001|Outcome|Dexmedetomidine-Induced Sleep|All healthy control subjects undergo a night of dexmedetomidine-induced sleep.
11083203|NCT01485393|OG001|Outcome|Dexmedetomidine-Induced Sleep|All healthy control subjects undergo a night of Dexmedetomidine-induced sleep.
11083204|NCT01485393|EG000|Reported Event|Zolpidem|This arm reflects the night of Zolpidem-induced sleep for all 10 participants.
11150551|NCT01877668|FG004|Participant Flow|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
11083205|NCT01485393|EG001|Reported Event|Dexmedetomidine|This arm reflects the night of Dexmedetomidine-induced sleep for all 10 participants.
11083206|NCT01485536|BG000|Baseline|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
11083207|NCT01485536|FG000|Participant Flow|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
11083208|NCT01485536|OG000|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
11083209|NCT01485536|EG000|Reported Event|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
11083210|NCT01485588|BG000|Baseline|hI-con1™ 60µg|This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
11083211|NCT01485588|BG001|Baseline|hI-con1™ 150µg|This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
11083212|NCT01485588|BG002|Baseline|hI-con1™ 300µg|This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.
11083213|NCT01485588|BG003|Baseline|Total|Total of all reporting groups
11083214|NCT01485588|FG000|Participant Flow|hI-con1™ 60µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083215|NCT01485588|FG001|Participant Flow|hI-con1™ 150µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083216|NCT01485588|FG002|Participant Flow|hI-con1™ 300µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083217|NCT01485588|OG000|Outcome|hI-con1™ 60µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083218|NCT01485588|OG001|Outcome|hI-con1™ 150µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083219|NCT01485588|OG002|Outcome|hI-con1™ 300µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083220|NCT01485588|OG000|Outcome|hI-con1™ 20µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083221|NCT01485588|OG002|Outcome|hI-con1™ 300µl|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083222|NCT01485588|EG000|Reported Event|hI-con1™ 60µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083223|NCT01485588|EG001|Reported Event|hI-con1™ 150µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11083224|NCT01485588|EG002|Reported Event|hI-con1™ 300µg|"Phase 1- This is a dose escalation study 60µg, 150µg, or 300 µg) given at baseline and then the subject is followed up to week 24.~hI-con1™: Phase 1: 60µg, 150µg, or 300µg per injection (in the eye) on Day 1 only"
11150552|NCT01877668|OG000|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
11357483|NCT03757039|EG001|Reported Event|DT1 MF|All subjects exposed to DT1 MF
11357484|NCT03757039|EG002|Reported Event|DACP MF|All subjects exposed to DACP MF
11150553|NCT01877668|OG001|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
11150554|NCT01877668|OG002|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
11150555|NCT01877668|OG003|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
11150556|NCT01877668|OG003|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
11150557|NCT01877668|OG004|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
11150558|NCT01877668|OG003|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
11150559|NCT01877668|OG004|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
11150560|NCT01877668|OG005|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
11150561|NCT01877668|EG000|Reported Event|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
11150562|NCT01877668|EG001|Reported Event|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
11150563|NCT01877668|EG002|Reported Event|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
11150564|NCT01877668|EG003|Reported Event|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
11150565|NCT01877668|EG004|Reported Event|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
11150566|NCT01877720|BG000|Baseline|Total Enrolled Patients|
11150567|NCT01877720|FG000|Participant Flow|PS-NAVA|"noninvasive PSV first for 15 minutes and then NAVA for 15 minutes~crossover of noninvasive respiratory support with NAVA mode and PSV"
11150568|NCT01877720|FG001|Participant Flow|NAVA-PS|"noninvasive NAVA first for 15 minutes and then PSV for 15 minutes~crossover of noninvasive respiratory support with NAVA mode and PSV"
11150569|NCT01877720|OG000|Outcome|NIV-NAVA|non-invasive NAVA
11150570|NCT01877720|OG001|Outcome|NIV-PS|non-invasive PS
11150571|NCT01877720|EG000|Reported Event|NIV-NAVA|non-invasive NAVA
11150572|NCT01877720|EG001|Reported Event|NIV-PS|non-invasive PS
11150573|NCT01877915|BG000|Baseline|Rivaroxaban|Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
11150574|NCT01877915|BG001|Baseline|Placebo|Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
11150575|NCT01877915|BG002|Baseline|Total|Total of all reporting groups
11150576|NCT01877915|FG000|Participant Flow|Rivaroxaban|Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
11150577|NCT01877915|FG001|Participant Flow|Placebo|Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
11150578|NCT01877915|OG000|Outcome|Rivaroxaban|Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
11150579|NCT01877915|OG001|Outcome|Placebo|Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
11150580|NCT01877915|EG000|Reported Event|Rivaroxaban|Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
11150581|NCT01877915|EG001|Reported Event|Placebo|Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
11150582|NCT01877941|BG000|Baseline|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
11083225|NCT01485614|BG000|Baseline|Sitagliptin|Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083226|NCT01485614|BG001|Baseline|Placebo/Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083227|NCT01485614|BG002|Baseline|Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083228|NCT01485614|BG003|Baseline|Placebo/Sitagliptin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083229|NCT01485614|BG004|Baseline|Total|Total of all reporting groups
11083230|NCT01485614|FG000|Participant Flow|Sitagliptin|Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083231|NCT01485614|FG001|Participant Flow|Placebo/Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083232|NCT01485614|FG002|Participant Flow|Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083233|NCT01485614|FG003|Participant Flow|Placebo/Sitagliptin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083234|NCT01485614|OG000|Outcome|Sitagliptin|Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20.
11083235|NCT01485614|OG001|Outcome|Placebo/Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20.
11083236|NCT01485614|OG002|Outcome|Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 0-20.
11083237|NCT01485614|OG003|Outcome|Placebo/Sitagliptin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20.
11083238|NCT01485614|OG000|Outcome|Placebo (Pooled)|Participants received placebo from Week 0-20.
11083239|NCT01485614|OG001|Outcome|Placebo (Pooled)|Participants received placebo from Week 0-20.
11083240|NCT01485614|OG000|Outcome|Sitagliptin|Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083241|NCT01485614|OG001|Outcome|Placebo/Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083242|NCT01485614|OG002|Outcome|Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083243|NCT01485614|OG003|Outcome|Placebo/Sitagliptin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083244|NCT01485614|EG000|Reported Event|Sitagliptin|Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11227670|NCT02385097|OG001|Outcome|Ropivacaine 0.75% (7.5 mg/mL)|"Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL~Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route"
11083245|NCT01485614|EG001|Reported Event|Placebo/Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083246|NCT01485614|EG002|Reported Event|Metformin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083247|NCT01485614|EG003|Reported Event|Placebo/Sitagliptin|Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants received 1 tablet of sitagliptin 100 mg prior to the morning meal and 2 tablets of placebo matching metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.
11083248|NCT01485627|BG000|Baseline|Intervention: Communication Training|"Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.~Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit."
11083249|NCT01485627|BG001|Baseline|Control: Usual Care|Patients will receive usual care
11083250|NCT01485627|BG002|Baseline|Total|Total of all reporting groups
11083251|NCT01485627|FG000|Participant Flow|Intervention: Communication|"Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.~Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit."
11083252|NCT01485627|FG001|Participant Flow|Control: Usual Care|Patients will receive usual care
11083253|NCT01485627|OG000|Outcome|Intervention|"Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.~Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit."
11083254|NCT01485627|OG001|Outcome|Control|Patients will receive usual care
11083255|NCT01485627|OG000|Outcome|Intervention: Communication|"Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.~Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit."
11227671|NCT02385097|EG000|Reported Event|Chloroprocaine HCl 2% (20 mg/mL)|"Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL~Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route"
11227672|NCT02385097|EG001|Reported Event|Ropivacaine 0.75% (7.5 mg/mL)|"Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL~Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route"
11227673|NCT02385240|BG000|Baseline|Test Product|"Brimonidine Topical Gel, 0.33 percent~Brimonidine Topical Gel, 0.33 percent (Perrigo)"
11083256|NCT01485627|OG001|Outcome|Control: Usual Care|Patients will receive usual care
11083257|NCT01485627|EG000|Reported Event|Intervention-patients|"Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.~Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit."
11083258|NCT01485627|EG001|Reported Event|Control-patients|Patients will receive usual care
11083259|NCT01485627|EG002|Reported Event|Intervention- Caregivers|"Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.~Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit."
11083260|NCT01485627|EG003|Reported Event|Intervention-caregivers|Patients will receive usual care
11083261|NCT01485640|BG000|Baseline|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
11083262|NCT01485640|FG000|Participant Flow|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
11083263|NCT01485640|OG000|Outcome|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
11083264|NCT01485640|EG000|Reported Event|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
11083265|NCT01485770|BG000|Baseline|Placebo, Then ADX-N05|Participants first received a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They then received ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).
11083266|NCT01485770|BG001|Baseline|ADX-N05, Then Placebo|Participants first received ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They then received a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
11083267|NCT01485770|BG002|Baseline|Total|Total of all reporting groups
11083268|NCT01485770|FG000|Participant Flow|Placebo, Then ADX-N05|Participants first received a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They then received ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).
11083269|NCT01485770|FG001|Participant Flow|ADX-N05, Then Placebo|Participants first received ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They then received a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
11083270|NCT01485770|OG000|Outcome|ADX-N05 300 mg|Participants took 2 tablets of 150 mg (300 mg) ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
11083271|NCT01485770|OG001|Outcome|Placebo|Participants took Placebo to match ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
11083272|NCT01485770|OG000|Outcome|ADX-N05 150 mg|Participants took 1 tablet of 150 mg ADX-N05 once a day during week 1 or week 3 of the 4-week study treatment period.
11083273|NCT01485770|OG001|Outcome|Placebo|Participants took Placebo to match ADX-N05 once a day during week 1 or week 3 of the 4-week study treatment period.
11083274|NCT01485770|EG000|Reported Event|ADX-N05|Participants received ADX-N05 150 mg once a day for seven days followed by 300 mg once a day for seven days during the 4-week study treatment period.
11083275|NCT01485770|EG001|Reported Event|Placebo|Participants received Placebo to match ADX-N05 once a day for 2 consecutive weeks during the 4-week study treatment period.
11083276|NCT01485796|BG000|Baseline|Subcutaneous Treatment With IGI, 10% and rHuPH20|This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
11083277|NCT01485796|FG000|Participant Flow|Subcutaneous Treatment With IGI, 10% and rHuPH20|Subcutaneous treatment with IGI, 10% and rHuPH20 occurred in 2 study epochs. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up. During the safety-follow up, subjects received IGI, 10% by either the IV or the SC route.
11083278|NCT01485796|OG000|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
11083279|NCT01485796|OG001|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
11083280|NCT01485796|OG000|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
11083281|NCT01485796|OG000|Outcome|Epoch 2 Data Set|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
11083282|NCT01485796|EG000|Reported Event|Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37)|This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
11083283|NCT01485796|EG001|Reported Event|Safety Follow-up (n=26)|Treatment with rHuPH20 was stopped as of August 2012 following discussion with the FDA. This decision was based on theoretical risks of exposure to anti-rHuPH20 antibodies, not because of any clinical adverse events. 26 subjects still active in Epoch 2 of the study went into a safety follow-up period and were treated with IGI, 10% (GAMMAGARD LIQUID) either intravenously or subcutaneously.
11083284|NCT01485887|BG000|Baseline|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
11083285|NCT01485887|FG000|Participant Flow|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
11083286|NCT01485887|OG000|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
11083287|NCT01485887|EG000|Reported Event|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
11083288|NCT01485991|BG000|Baseline|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
11083289|NCT01485991|BG001|Baseline|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
11083290|NCT01485991|BG002|Baseline|Total|Total of all reporting groups
11083291|NCT01485991|FG000|Participant Flow|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
11083292|NCT01485991|FG001|Participant Flow|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
11083293|NCT01485991|OG000|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
11083294|NCT01485991|OG001|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
11083295|NCT01485991|EG000|Reported Event|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
11083296|NCT01485991|EG001|Reported Event|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
11083297|NCT01486043|BG000|Baseline|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
11083298|NCT01486043|FG000|Participant Flow|Metformin and Insulin Therapy|"For the prospectively recruited arm (metformin plus insulin therapy), a total of 4 subjects were recruited. Two subjects were withdrawn from the study after laboratory studies revealed liver enzymes (AST) levels that were above that allowed for the study at the time. An additional 2 subjects were recruited in the study.~For the retrospective chart review portion of our study, 12 patients were included after conducting chart review of cases from January 2007 to August 2011."
11083299|NCT01486043|OG000|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
11083300|NCT01486043|EG000|Reported Event|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
11083301|NCT01486199|BG000|Baseline|CF Pediatric|Cystic Fibrosis subjects ages 6-14
11083302|NCT01486199|BG001|Baseline|Controls Adult|Adult control subjects 18 or older
11083303|NCT01486199|BG002|Baseline|Total|Total of all reporting groups
11083304|NCT01486199|FG000|Participant Flow|CF Pediatric|Cystic Fibrosis subjects ages 6-14
11083305|NCT01486199|FG001|Participant Flow|Controls Adult|Adult control subjects 18 or older
11083306|NCT01486199|OG000|Outcome|CF Pediatric|CF subjects ages 6-14
11083307|NCT01486199|OG001|Outcome|Controls Adult|Adult control subjects 18 or older
11083308|NCT01486199|EG000|Reported Event|CF Pediatric|cystic fibrosis subjects ages 6-14
11083309|NCT01486199|EG001|Reported Event|Controls Adult|adult controls 18 or older
11083310|NCT01486238|BG000|Baseline|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
11083311|NCT01486238|BG001|Baseline|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
11083312|NCT01486238|BG002|Baseline|Total|Total of all reporting groups
11083313|NCT01486238|FG000|Participant Flow|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
11083314|NCT01486238|FG001|Participant Flow|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
11083315|NCT01486238|OG000|Outcome|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
11083316|NCT01486238|OG001|Outcome|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
11083317|NCT01486238|EG000|Reported Event|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
11083318|NCT01486238|EG001|Reported Event|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
11083319|NCT01486316|BG000|Baseline|Control Arm|"Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083320|NCT01486316|BG001|Baseline|Risk Status Guided|"Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083321|NCT01486316|BG002|Baseline|Not Randomized|Subjects who were not randomized
11083322|NCT01486316|BG003|Baseline|Total|Total of all reporting groups
11083323|NCT01486316|FG000|Participant Flow|Control Arm|"The Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083324|NCT01486316|FG001|Participant Flow|Risk Status Guided|"Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083325|NCT01486316|FG002|Participant Flow|No Implant|Subjects who did not undergo an implant attempt and were not randomized.
11083326|NCT01486316|FG003|Participant Flow|Implanted Not Randomized|Subject were implanted and not randomized
11083327|NCT01486316|OG000|Outcome|Control Arm|"The Control arm will be observed between months 13-18. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location), but study doctors for the subjects will have access to the risk status.~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083328|NCT01486316|OG001|Outcome|Risk Status Guided|"Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083329|NCT01486316|OG000|Outcome|Control Arm|"The Control arm will be observed between months 13-18, and so only the subjects followed beyond 12 months are included in the analysis. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location), but study doctors for the subjects will have access to the risk status.~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11227674|NCT02385240|BG001|Baseline|Reference Product|"Brimonidine Topical Gel, 0.33 percent (Reference)~Brimonidine Topical Gel, 0.33 percent (Reference)"
11083330|NCT01486316|OG000|Outcome|Risk Status Guided|"Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083331|NCT01486316|OG001|Outcome|Control Arm|"The Control arm will be observed between months 13-18, and so only Control arm subjects followed beyond 12 months are included. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location), but study doctors for the subjects will have access to the risk status.~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083332|NCT01486316|EG000|Reported Event|Control Arm|"Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status.The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083333|NCT01486316|EG001|Reported Event|Risk Status Guided|"Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).~Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
11083334|NCT01486446|BG000|Baseline|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
11083335|NCT01486446|BG001|Baseline|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
11083336|NCT01486446|BG002|Baseline|Total|Total of all reporting groups
11083337|NCT01486446|FG000|Participant Flow|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
11083338|NCT01486446|FG001|Participant Flow|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
11083339|NCT01486446|OG000|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
11083340|NCT01486446|OG001|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
11083341|NCT01486446|EG000|Reported Event|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
11083342|NCT01486446|EG001|Reported Event|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
11083343|NCT01486615|BG000|Baseline|Melatonin|premedication 1-2 hour prior to anesthesia
11083344|NCT01486615|BG001|Baseline|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
11083345|NCT01486615|BG002|Baseline|Alprazolam|premedication 1-2 hr prior to anesthesia
11083346|NCT01486615|BG003|Baseline|Placebo|premedication 1-2 hr prior to anesthesia
11083347|NCT01486615|BG004|Baseline|Total|Total of all reporting groups
11083348|NCT01486615|FG000|Participant Flow|Melatonin|Oral premedication with 3 mg melatonin tablet (Meloset) 1-2 hour prior to anesthesia
11083349|NCT01486615|FG001|Participant Flow|Melatonin and Alprazolam|Oral premedication with a 3 mg melatonin and 0.5 mg alprazolam combination tablet (Stressnil) 1-2 hrs prior to anesthesia
11083350|NCT01486615|FG002|Participant Flow|Alprazolam|Oral premedication with 0.5 mg alprazolam (Alprax) 1-2 hr prior to anesthesia
11083351|NCT01486615|FG003|Participant Flow|Placebo|Oral premedication with a similar looking placebo tablet 1-2 hr prior to anesthesia
11083352|NCT01486615|OG000|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
11083353|NCT01486615|OG001|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
11083354|NCT01486615|OG002|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
11083355|NCT01486615|OG003|Outcome|Placebo|premedicated 1-2 hours before anesthesia
11083356|NCT01486615|EG000|Reported Event|Melatonin|premedication 1-2 hour prior to anesthesia
11083357|NCT01486615|EG001|Reported Event|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
11083358|NCT01486615|EG002|Reported Event|Alprazolam|premedication 1-2 hr prior to anesthesia
11083359|NCT01486615|EG003|Reported Event|Placebo|premedication 1-2 hr prior to anesthesia
11083360|NCT01486758|BG000|Baseline|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
11083361|NCT01486758|BG001|Baseline|Placebo|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
11083362|NCT01486758|BG002|Baseline|Total|Total of all reporting groups
11083363|NCT01486758|FG000|Participant Flow|Placebo|Placebo for 14 days.
11083364|NCT01486758|FG001|Participant Flow|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
11083365|NCT01486758|OG000|Outcome|Placebo|Placebo for 14 days
11083366|NCT01486758|OG001|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
11083367|NCT01486758|OG000|Outcome|Placebo|Placebo for 14 days.
11083368|NCT01486758|EG000|Reported Event|Placebo|Placebo for 14 days.
11083369|NCT01486758|EG001|Reported Event|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
11083370|NCT01486784|BG000|Baseline|Phase 1 DL1|"26mg/m2/dose IV once per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083371|NCT01486784|BG001|Baseline|Phase 1 DL-1|"17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083372|NCT01486784|BG002|Baseline|Phase 1 DL-1a|"17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083373|NCT01486784|BG003|Baseline|Phase 1 DL-1b|"17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083374|NCT01486784|BG004|Baseline|Phase 1 DL-1c|"22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083375|NCT01486784|BG005|Baseline|Phase 1 DL-1d|"17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083376|NCT01486784|BG006|Baseline|Total|Total of all reporting groups
11083377|NCT01486784|FG000|Participant Flow|Phase 1 DL1|"26mg/m2/dose IV once per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083378|NCT01486784|FG001|Participant Flow|Phase 1 DL-1|"17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083379|NCT01486784|FG002|Participant Flow|Phase 1 DL-1a|"17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083380|NCT01486784|FG003|Participant Flow|Phase 1 DL-1b|"17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083381|NCT01486784|FG004|Participant Flow|Phase 1 DL-1c|"22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083382|NCT01486784|FG005|Participant Flow|Phase 1 DL-1d|"17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083383|NCT01486784|OG000|Outcome|Phase 1 DL1|"26mg/m2/dose IV once per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083384|NCT01486784|OG001|Outcome|Phase 1 DL-1|"17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083385|NCT01486784|OG002|Outcome|Phase 1 DL-1a|"17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083386|NCT01486784|OG003|Outcome|Phase 1 DL-1b|"17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083387|NCT01486784|OG004|Outcome|Phase 1 DL-1c|"22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083388|NCT01486784|OG005|Outcome|Phase 1 DL-1d|"17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083389|NCT01486784|EG000|Reported Event|Phase 1 DL1|"26mg/m2/dose IV once per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083390|NCT01486784|EG001|Reported Event|Phase 1 DL-1|"17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083391|NCT01486784|EG002|Reported Event|Phase 1 DL-1a|"17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083392|NCT01486784|EG003|Reported Event|Phase 1 DL-1b|"17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083393|NCT01486784|EG004|Reported Event|Phase 1 DL-1c|"22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083394|NCT01486784|EG005|Reported Event|Phase 1 DL-1d|"22mg/m2/dose IV twice per week x 4weeks of 4 week cycle~Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion"
11083395|NCT01486810|BG000|Baseline|Lisdexamfetamine and Medication Management|"Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.~Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks~medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders."
11083396|NCT01486810|FG000|Participant Flow|Lisdexamfetamine and Medication Management|"Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.~Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks~medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders."
11083397|NCT01486810|OG000|Outcome|Lisdexamfetamine and Medication Management|"Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.~Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks~medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders."
11083398|NCT01486810|EG000|Reported Event|Lisdexamfetamine and Medication Management|"Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.~Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks~medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders."
11083399|NCT01486927|BG000|Baseline|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
11083400|NCT01486927|FG000|Participant Flow|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover pharmacokinetic [PK] analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 exposure days (EDs). In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
11083401|NCT01486927|OG000|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
11083402|NCT01486927|OG001|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
11083403|NCT01486927|OG002|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
11357485|NCT03757039|EG003|Reported Event|PALs|All subjects exposed to PALs
11083404|NCT01486927|OG000|Outcome|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
11227675|NCT02385240|BG002|Baseline|Placebo Gel|"Placebo~Placebo gel"
11083405|NCT01486927|OG000|Outcome|rVIII-SingleChain Surgical|The rVIII-SingleChain Surgical group included all subjects enrolled in the surgical sub-study who received at least 1 dose of rVIII-SingleChain during the surgical sub-study. There were 13 subjects in the rVIII-SingleChain Surgical group.
11083406|NCT01486927|OG000|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
11083407|NCT01486927|OG002|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least one dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
11083408|NCT01486927|OG000|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
11083409|NCT01486927|EG000|Reported Event|Safety Population|The Safety Population comprised all subjects treated with rVIII-SingleChain.
11083410|NCT01486966|BG000|Baseline|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
11083411|NCT01486966|BG001|Baseline|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
11083412|NCT01486966|BG002|Baseline|Total|Total of all reporting groups
11227676|NCT02385240|BG003|Baseline|Total|Total of all reporting groups
11083413|NCT01486966|FG000|Participant Flow|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
11083414|NCT01486966|FG001|Participant Flow|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
11083415|NCT01486966|OG000|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
11083416|NCT01486966|OG001|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
11083417|NCT01486966|EG000|Reported Event|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
11083418|NCT01486966|EG001|Reported Event|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
11083419|NCT01487161|BG000|Baseline|FX006 10 mg|Single 3 mL IA injection
11083420|NCT01487161|BG001|Baseline|FX006 40 mg|Single 3 mL IA injection
11083421|NCT01487161|BG002|Baseline|FX006 60 mg|Single 3 mL IA injection
11083422|NCT01487161|BG003|Baseline|TCA IR (40 mg)|Single 1 mL IA injection
11083423|NCT01487161|BG004|Baseline|Total|Total of all reporting groups
11083424|NCT01487161|FG000|Participant Flow|FX006 10 mg|58 subjects received FX006 10 mg as a single 3 mL IA injection.
11083425|NCT01487161|FG001|Participant Flow|FX006 40 mg|59 subjects received FX006 40 mg as a single 3 mL IA injection.
11083426|NCT01487161|FG002|Participant Flow|FX006 60 mg|60 subjects received FX006 60 mg as a single 3 mL IA injection.
11083427|NCT01487161|FG003|Participant Flow|TCA IR (40 mg)|51 subjects received TCA IR 40 mg as a single 1 mL IA injection.
11083428|NCT01487161|OG000|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
11083429|NCT01487161|OG001|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11083430|NCT01487161|OG000|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
11083431|NCT01487161|OG001|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
11083432|NCT01487161|OG002|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11083433|NCT01487161|OG002|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
11083434|NCT01487161|OG003|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11227677|NCT02385240|FG000|Participant Flow|Test Product|"Brimonidine Topical Gel, 0.33 percent~Brimonidine Topical Gel, 0.33 percent (Perrigo)"
11227678|NCT02385240|FG001|Participant Flow|Reference Product|"Brimonidine Topical Gel, 0.33 percent (Reference)~Brimonidine Topical Gel, 0.33 percent (Reference)"
11227679|NCT02385240|FG002|Participant Flow|Placebo Gel|"Placebo~Placebo gel"
11083435|NCT01487161|OG003|Outcome|TCA IR 40 mg|FX006: Single 1 mL IA injection
11083436|NCT01487161|OG003|Outcome|TCA IR (40 mg)|TCA IR: Single 1 mL IA injection
11083437|NCT01487161|EG000|Reported Event|FX006 10 mg|FX006: Single 3 mL IA injection
11083438|NCT01487161|EG001|Reported Event|FX006 40 mg|FX006: Single 3 mL IA injection
11083439|NCT01487161|EG002|Reported Event|FX006 60 mg|FX006: Single 3 mL IA injection
11083440|NCT01487161|EG003|Reported Event|TCA IR (40 mg)|TCA IR: Single 1 mL IA injection
11083441|NCT01487200|BG000|Baseline|FX006 10mg|Single 3 mL IA injection
11083442|NCT01487200|BG001|Baseline|FX006 40mg|Single 3 mL IA injection
11083443|NCT01487200|BG002|Baseline|FX006 60 mg|Single 3 mL IA injection
11083444|NCT01487200|BG003|Baseline|TCA IR (40 mg)|Single 1 mL IA injection
11083445|NCT01487200|BG004|Baseline|Total|Total of all reporting groups
11083446|NCT01487200|FG000|Participant Flow|FX006 10mg|5 subjects received FX006 10 mg as a single 3 mL IA injection.
11083447|NCT01487200|FG001|Participant Flow|FX006 40mg|7 subjects received FX006 40 mg as a single 3 mL IA injection.
11083448|NCT01487200|FG002|Participant Flow|FX006 60 mg|7 subjects received FX006 60 mg as a single 3 mL IA injection.
11083449|NCT01487200|FG003|Participant Flow|TCA IR 40 mg|5 subjects received commercially available triamcinolone acetonide (40 mg) as a single 1 mL IA injection.
11083450|NCT01487200|OG000|Outcome|FX006 10mg|Single 3 mL IA injection
11083451|NCT01487200|OG001|Outcome|FX006 40mg|Single 3 mL IA injection
11083452|NCT01487200|OG002|Outcome|FX006 60 mg|Single 3 mL IA injection
11083453|NCT01487200|OG003|Outcome|TCA IR 40 mg|Single 1 mL IA injection
11083454|NCT01487200|OG003|Outcome|TCA IR 40 mg|Single 1 mL IA injection of commercially available triamcinolone acetonide
11083455|NCT01487200|EG000|Reported Event|FX006 10mg|Single 3 mL IA injection
11083456|NCT01487200|EG001|Reported Event|FX006 40mg|Single 3 mL IA injection
11083457|NCT01487200|EG002|Reported Event|FX006 60 mg|Single 3 mL IA injection
11083458|NCT01487200|EG003|Reported Event|TCA IR 40 mg|Single 1 mL IA injection of commercially available triamcinolone acetonide
11083459|NCT01487265|BG000|Baseline|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
11083460|NCT01487265|FG000|Participant Flow|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
11083461|NCT01487265|OG000|Outcome|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
11083462|NCT01487265|EG000|Reported Event|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
11083463|NCT01487525|BG000|Baseline|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
11083464|NCT01487525|BG001|Baseline|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
11083465|NCT01487525|BG002|Baseline|Total|Total of all reporting groups
11083466|NCT01487525|FG000|Participant Flow|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
11083467|NCT01487525|FG001|Participant Flow|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
11083468|NCT01487525|OG000|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
11083469|NCT01487525|OG001|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
11083470|NCT01487525|EG000|Reported Event|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
11083471|NCT01487525|EG001|Reported Event|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
11083472|NCT01487577|BG000|Baseline|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
11083473|NCT01487577|FG000|Participant Flow|Mycophenolate Mofetil|Pharmacokinetics-based targeting of Mycophenolate mofetil
11083474|NCT01487577|OG000|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
11083475|NCT01487577|EG000|Reported Event|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
11083476|NCT01487668|BG000|Baseline|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
11227680|NCT02385240|OG000|Outcome|Test Product|"Brimonidine Topical Gel, 0.33 percent~Brimonidine Topical Gel, 0.33 percent (Perrigo)"
11227681|NCT02385240|OG001|Outcome|Reference Product|"Brimonidine Topical Gel, 0.33 percent (Reference)~Brimonidine Topical Gel, 0.33 percent (Reference)"
11227682|NCT02385240|OG002|Outcome|Placebo Gel|"Placebo~Placebo gel"
11227683|NCT02385240|EG000|Reported Event|Test Product|"Brimonidine Topical Gel, 0.33 percent~Brimonidine Topical Gel, 0.33 percent (Perrigo)"
11083477|NCT01487668|BG001|Baseline|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
11083478|NCT01487668|BG002|Baseline|Total|Total of all reporting groups
11083479|NCT01487668|FG000|Participant Flow|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
11083480|NCT01487668|FG001|Participant Flow|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
11083481|NCT01487668|OG000|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
11083482|NCT01487668|OG001|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
11083483|NCT01487668|OG000|Outcome|Arm 1 (Usual Care)|"Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.~."
11083484|NCT01487668|OG001|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages
11083485|NCT01487668|EG000|Reported Event|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
11083486|NCT01487668|EG001|Reported Event|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
11083487|NCT01487863|BG000|Baseline|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
11083488|NCT01487863|BG001|Baseline|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
11083489|NCT01487863|BG002|Baseline|Total|Total of all reporting groups
11083490|NCT01487863|FG000|Participant Flow|Concurrent Arm|"Subjects received sipuleucel-T with concurrent abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
11083491|NCT01487863|FG001|Participant Flow|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
11227684|NCT02385240|EG001|Reported Event|Reference Product|"Brimonidine Topical Gel, 0.33 percent (Reference)~Brimonidine Topical Gel, 0.33 percent (Reference)"
11227685|NCT02385240|EG002|Reported Event|Placebo Gel|"Placebo~Placebo gel"
11227686|NCT02385318|BG000|Baseline|Test Product|"Ingenol Mebutate~Ingenol Mebutate (Perrigo)"
11227687|NCT02385318|BG001|Baseline|Reference Product|"Ingenol Mebutate~Ingenol Mebutate (Reference)"
11227688|NCT02385318|BG002|Baseline|Placebo Product|"Placebo gel~Placebo gel"
11227689|NCT02385318|BG003|Baseline|Total|Total of all reporting groups
11227690|NCT02385318|FG000|Participant Flow|Test Product|Ingenol Mebutate gel (Perrigo)
11083492|NCT01487863|OG000|Outcome|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
11083493|NCT01487863|OG001|Outcome|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
11083494|NCT01487863|EG000|Reported Event|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
11083495|NCT01487863|EG001|Reported Event|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
11083496|NCT01487954|BG000|Baseline|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
11083497|NCT01487954|BG001|Baseline|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
11083498|NCT01487954|BG002|Baseline|Total|Total of all reporting groups
11083499|NCT01487954|FG000|Participant Flow|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
11083500|NCT01487954|FG001|Participant Flow|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
11083501|NCT01487954|OG000|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
11083502|NCT01487954|OG001|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
11083503|NCT01487954|EG000|Reported Event|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
11083504|NCT01487954|EG001|Reported Event|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
11083505|NCT01488019|BG000|Baseline|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20mcg/2 mL, twice daily nebulization for 52 weeks"
11083506|NCT01488019|BG001|Baseline|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
11083507|NCT01488019|BG002|Baseline|Total|Total of all reporting groups
11083508|NCT01488019|FG000|Participant Flow|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
11083509|NCT01488019|FG001|Participant Flow|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
11083510|NCT01488019|OG000|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
11083511|NCT01488019|OG001|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
11083512|NCT01488019|OG000|Outcome|Perforomist Inhalation Solution|"Active~Perforomist, nebulization, COPD: Perforomist, 20 mcg/2 mL, twice daily for 52 weeks"
11083513|NCT01488019|OG001|Outcome|Matching Placebo|"Placebo~Perforomist-Placebo: Placebo vehicle, 2mL, twice daily for 52 weeks"
11083514|NCT01488019|EG000|Reported Event|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
11083515|NCT01488019|EG001|Reported Event|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
11083516|NCT01488071|BG000|Baseline|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
11083517|NCT01488071|BG001|Baseline|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
11083518|NCT01488071|BG002|Baseline|Total|Total of all reporting groups
11083519|NCT01488071|FG000|Participant Flow|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
11083520|NCT01488071|FG001|Participant Flow|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
11083521|NCT01488071|OG000|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
11083522|NCT01488071|OG001|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
11357486|NCT03756883|BG000|Baseline|Test|"Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg~Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation~Dose: 1 inhalation twice daily"
11083523|NCT01488071|EG000|Reported Event|Vortioxetine|
11083524|NCT01488071|EG001|Reported Event|Agomelatine|
11083525|NCT01488097|BG000|Baseline|Open-Label Sebelipase Alfa|Participants were administered sebelipase alfa qw as an IV infusion at the same dose received in Study LAL-CL01 (0.35, 1, or 3 mg/kg) for 4 weeks. After the initial 4 qw doses, participants transitioned to dosing qow at either 1 mg/kg (participants who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (participants who initiated dosing at 3 mg/kg qw). Subsequent modifications to the dose and dosing frequency were permitted for individual participants based on observed safety, tolerability, and clinical response to treatment. Participants could continue to receive treatment with sebelipase alfa for up to 5 years.
11083526|NCT01488097|FG000|Participant Flow|Open-Label Sebelipase Alfa|Participants were administered sebelipase alfa once weekly (qw) as an intravenous (IV) infusion at the same dose received in Study LAL-CL01 (0.35, 1, or 3 milligrams per kilogram [mg/kg]) for 4 weeks. After the initial 4 qw doses, participants transitioned to dosing every other week (qow) at either 1 mg/kg (participants who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (participants who initiated dosing at 3 mg/kg qw). Subsequent modifications to the dose and dosing frequency were permitted for individual participants based on observed safety, tolerability, and clinical response to treatment. Participants could continue to receive treatment with sebelipase alfa for up to 5 years.
11083527|NCT01488097|OG000|Outcome|Open-Label Sebelipase Alfa|Participants were administered sebelipase alfa qw as an IV infusion at the same dose received in Study LAL-CL01 (0.35, 1, or 3 mg/kg) for 4 weeks. After the initial 4 qw doses, participants transitioned to dosing qow at either 1 mg/kg (participants who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (participants who initiated dosing at 3 mg/kg qw). Subsequent modifications to the dose and dosing frequency were permitted for individual participants based on observed safety, tolerability, and clinical response to treatment. Participants could continue to receive treatment with sebelipase alfa for up to 5 years.
11083528|NCT01488097|EG000|Reported Event|Open-Label Sebelipase Alfa|Participants were administered sebelipase alfa qw as an IV infusion at the same dose received in Study LAL-CL01 (0.35, 1, or 3 mg/kg) for 4 weeks. After the initial 4 qw doses, participants transitioned to qow dosing at either 1 mg/kg (participants who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (participants who initiated dosing at 3 mg/kg qw). Subsequent modifications to the dose and dosing frequency were permitted for individual participants based on observed safety, tolerability, and clinical response to treatment. Participants could continue to receive treatment with sebelipase alfa for up to 5 years.
11083529|NCT01488188|BG000|Baseline|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
11083530|NCT01488188|BG001|Baseline|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
11083531|NCT01488188|BG002|Baseline|Total|Total of all reporting groups
11083532|NCT01488188|FG000|Participant Flow|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
11083533|NCT01488188|FG001|Participant Flow|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
11083534|NCT01488188|OG000|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
11083535|NCT01488188|OG001|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
11083536|NCT01488188|EG000|Reported Event|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
11083537|NCT01488188|EG001|Reported Event|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
11083538|NCT01488279|BG000|Baseline|Sitagliptin, Then Placebo|This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days. There was a 4-6 week washout, then subjects crossed over to dex + placebo.
11083539|NCT01488279|BG001|Baseline|Placebo, Then Sitagliptin|This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days. There was a 4-6 weeks washout, then subjects crossed over to dex + sitagliptin.
11083540|NCT01488279|BG002|Baseline|Total|Total of all reporting groups
11083541|NCT01488279|FG000|Participant Flow|Sitagliptin, Then Placebo|Dex 2.5 mg + sitagliptin 100 mg daily (7 days), washout (4-6 weeks), dex + placebo (7 days)
11083542|NCT01488279|FG001|Participant Flow|Placebo, Then Sitaglipton|Dex 2.5 mg + placebo (7 days), washout (4-6 weeks), Sitalgiptin + placebo ( 7 days)
11083543|NCT01488279|OG000|Outcome|Sitagliptin|This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.
11083544|NCT01488279|OG001|Outcome|Placebo|This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days.
11083545|NCT01488279|OG001|Outcome|Placebo|This arm involves randomization to dexamethasone 2.5 mg + placebo daily x 7 days followed by MTT and IVGTT on subsequent days.
11083546|NCT01488279|OG000|Outcome|Sitagliptin|Participants received dex 2.5 mg + sitagliptin 100 mg daily x 7 days.
11083547|NCT01488279|OG001|Outcome|Placebo|Participants received dex 2.5 mg + placebo daily x 7 days.
11083548|NCT01488279|EG000|Reported Event|Sitagliptin, Then Placebo|"This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.~Dexamethasone medication: 2.5 mg daily dexamethasone x 7 days"
11083549|NCT01488279|EG001|Reported Event|Placebo, Then Sitagliptin|"This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days~Dexamethasone medication: 2.5 mg daily dexamethasone x 7 days"
11083550|NCT01488318|BG000|Baseline|CETUXIMAB + DASATINIB|
11083551|NCT01488318|FG000|Participant Flow|CETUXIMAB + DASATINIB|Cetuximab dosed at 250 mg/m^2/week and Dasatinib dosed at 150 mg daily
11083552|NCT01488318|OG000|Outcome|CETUXIMAB + DASATINIB|
11083553|NCT01488318|EG000|Reported Event|CETUXIMAB + DASATINIB|Cetuximab dosed at 250 mg/m^2/week and Dasatinib dosed at 150 mg daily
11083554|NCT01488370|BG000|Baseline|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
11083555|NCT01488370|BG001|Baseline|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
11083556|NCT01488370|BG002|Baseline|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
11357487|NCT03756883|BG001|Baseline|Reference|"ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder~Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation~Dose: 1 inhalation twice daily"
11083557|NCT01488370|BG003|Baseline|Total|Total of all reporting groups
11083558|NCT01488370|FG000|Participant Flow|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
11083559|NCT01488370|FG001|Participant Flow|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
11083560|NCT01488370|FG002|Participant Flow|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
11083561|NCT01488370|OG000|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
11083562|NCT01488370|OG001|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
11083563|NCT01488370|OG002|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
11083564|NCT01488370|EG000|Reported Event|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
11083565|NCT01488370|EG001|Reported Event|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
11083566|NCT01488370|EG002|Reported Event|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
11083567|NCT01488409|BG000|Baseline|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
11083568|NCT01488409|BG001|Baseline|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
11083569|NCT01488409|BG002|Baseline|Total|Total of all reporting groups
11083570|NCT01488409|FG000|Participant Flow|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
11083571|NCT01488409|FG001|Participant Flow|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
11083572|NCT01488409|OG000|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
11083573|NCT01488409|OG001|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
11083574|NCT01488409|EG000|Reported Event|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
11083575|NCT01488409|EG001|Reported Event|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
11083576|NCT01488448|BG000|Baseline|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
11083577|NCT01488448|BG001|Baseline|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
11083578|NCT01488448|BG002|Baseline|Total|Total of all reporting groups
11083579|NCT01488448|FG000|Participant Flow|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
11083580|NCT01488448|FG001|Participant Flow|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
11083581|NCT01488448|OG000|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
11083582|NCT01488448|OG001|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
11083583|NCT01488448|OG000|Outcome|Nebulized Hypertonic Saline|"4mL nebulized 3% sodium chloride every 4 hours until discharge~3% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
11083584|NCT01488448|OG001|Outcome|Nebulized Normal Saline|"4 mL nebulized 0.9% sodium chloride every 4 hours until discharge~0.9% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
11083585|NCT01488448|EG000|Reported Event|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
11083586|NCT01488448|EG001|Reported Event|Normal Saline|4mL nebulized 0.9% sodium chloride every 4 hours until discharge
11357488|NCT03756883|BG002|Baseline|Placebo|"Placebo~Placebo Inhalation Powder: No active content~Dose: 1 inhalation twice daily"
11083587|NCT01488487|BG000|Baseline|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
11083588|NCT01488487|FG000|Participant Flow|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
11083589|NCT01488487|OG000|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
11083590|NCT01488487|EG000|Reported Event|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
11083591|NCT01488578|BG000|Baseline|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
11083592|NCT01488578|FG000|Participant Flow|Tolterodine Tartrate|Participants taking Tolterodine tartrate.
11083593|NCT01488578|OG000|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
11083594|NCT01488578|OG000|Outcome|With Concomitant Drugs|Participants with concomitant drugs who took tolterodine according to Japanese Package Insert.
11083595|NCT01488578|OG001|Outcome|Without Concomitant Drugs|Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.
11083596|NCT01488578|OG000|Outcome|With Non-drug Therapies|Participants with non-drug therapies who took tolterodine according to Japanese Package Insert.
11083597|NCT01488578|OG001|Outcome|Without Non-drug Therapies|Participants without non-drug therapies who took tolterodine according to Japanese Package Insert.
11083598|NCT01488578|OG000|Outcome|Male|Male participants who took tolterodine according to Japanese Package Insert.
11083599|NCT01488578|OG001|Outcome|Female|Female participants who took tolterodine according to Japanese Package Insert.
11083600|NCT01488578|OG000|Outcome|With Complications|Participants with complications who took tolterodine according to Japanese Package Insert.
11083601|NCT01488578|OG001|Outcome|Without Complications|Participants without complications who took tolterodine according to Japanese Package Insert.
11083602|NCT01488578|OG000|Outcome|<65 Years|Participants with < 65 years who took tolterodine according to Japanese Package Insert.
11083603|NCT01488578|OG001|Outcome|>=65 Years|Participants with >= 65 years who took tolterodine according to Japanese Package Insert.
11083604|NCT01488578|OG000|Outcome|With BPH|Participants with complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
11083605|NCT01488578|OG001|Outcome|Without BPH|Participants without complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
11083606|NCT01488578|OG000|Outcome|Mild|Participants with mild OAB who took tolterodine according to Japanese Package Insert.
11083607|NCT01488578|OG001|Outcome|Moderate|Participants with moderate OAB who took tolterodine according to Japanese Package Insert.
11083608|NCT01488578|OG002|Outcome|Severe|Participants with severe OAB who took tolterodine according to Japanese Package Insert.
11083609|NCT01488578|OG000|Outcome|With Urinary Urgency|Participants with urinary urgency who took tolterodine according to Japanese Package Insert.
11083610|NCT01488578|OG001|Outcome|Without Urinary Urgency|Participants without urinary urgency who took tolterodine according to Japanese Package Insert.
11083611|NCT01488578|OG000|Outcome|No Urination|Participants with no urination who took tolterodine according to Japanese Package Insert.
11083612|NCT01488578|OG001|Outcome|1 Urination|Participants with 1 time urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
11083613|NCT01488578|OG002|Outcome|2 Urinations|Participants with 2 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
11083614|NCT01488578|OG003|Outcome|>= 3 Urinations|Participants with >= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
11083615|NCT01488578|OG000|Outcome|1 to 2 Episodes|Participants with 1 or 2 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
11083616|NCT01488578|OG001|Outcome|3 to 4 Episodes|Participants with 3 or 4 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
11083617|NCT01488578|OG002|Outcome|>= 5 Episodes|Participants with >= 5 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
11083618|NCT01488578|OG000|Outcome|With Previous Treatment|Participants with previous treatment of OAB who took tolterodine according to Japanese Package Insert.
11083619|NCT01488578|OG001|Outcome|Without Previous Treatment|Participants without previous treatment of OAB who took tolterodine according to Japanese Package Insert.
11083620|NCT01488578|EG000|Reported Event|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
11227691|NCT02385318|FG001|Participant Flow|Reference Product|Ingenol Mebutate gel (Reference)
11227692|NCT02385318|FG002|Participant Flow|Placebo Product|"Placebo gel~Placebo gel"
11227693|NCT02385318|OG000|Outcome|Test Product|"Ingenol Mebutate~Ingenol Mebutate (Perrigo)"
11227694|NCT02385318|OG001|Outcome|Reference Product|"Ingenol Mebutate~Ingenol Mebutate (Reference)"
11227695|NCT02385318|OG002|Outcome|Placebo Product|"Placebo gel~Placebo gel"
11083621|NCT01488708|BG000|Baseline|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
11083622|NCT01488708|BG001|Baseline|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
11083623|NCT01488708|BG002|Baseline|Total|Total of all reporting groups
11083624|NCT01488708|FG000|Participant Flow|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
11083625|NCT01488708|FG001|Participant Flow|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
11083626|NCT01488708|OG000|Outcome|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
11083627|NCT01488708|OG001|Outcome|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
11083628|NCT01488708|EG000|Reported Event|LY 2127399 Q2W Treatment|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
11092017|NCT01537081|BG000|Baseline|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
11227696|NCT02385318|EG000|Reported Event|Test Product|"Ingenol Mebutate~Ingenol Mebutate (Perrigo)"
11357489|NCT03756883|BG003|Baseline|Total|Total of all reporting groups
11357490|NCT03756883|FG000|Participant Flow|Test|"Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg~Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation~Dose: 1 inhalation twice daily"
11083629|NCT01488708|EG001|Reported Event|LY2127399 Q4W Treatment|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
11083630|NCT01488708|EG002|Reported Event|LY 2127399 Q2W Follow Up|If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. Follow up.
11083631|NCT01488708|EG003|Reported Event|LY2127399 Q4W Follow Up|If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. Follow up.
11083632|NCT01488877|BG000|Baseline|Entire Study Population|All participants who were enrolled in this study.
11083633|NCT01488877|FG000|Participant Flow|PF-03882845 Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
11083634|NCT01488877|FG001|Participant Flow|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
11083635|NCT01488877|FG002|Participant Flow|Spironolactone Placebo|Similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
11083636|NCT01488877|OG000|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
11083637|NCT01488877|OG001|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
11083638|NCT01488877|OG000|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
11083639|NCT01488877|EG000|Reported Event|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
11083640|NCT01488877|EG001|Reported Event|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
11083641|NCT01488994|BG000|Baseline|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
11083642|NCT01488994|BG001|Baseline|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to <12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
11083643|NCT01488994|BG002|Baseline|Total|Total of all reporting groups
11083644|NCT01488994|FG000|Participant Flow|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
11083645|NCT01488994|FG001|Participant Flow|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
11083646|NCT01488994|OG000|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
11092018|NCT01537081|BG001|Baseline|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
11227697|NCT02385318|EG001|Reported Event|Reference Product|"Ingenol Mebutate~Ingenol Mebutate (Reference)"
11227698|NCT02385318|EG002|Reported Event|Placebo Product|"Placebo gel~Placebo gel"
11083647|NCT01488994|OG001|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
11083648|NCT01488994|OG002|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
11083649|NCT01488994|OG000|Outcome|Overall Study Arm|No participants
11083650|NCT01488994|OG002|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
11083651|NCT01488994|OG000|Outcome|BAX326 < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
11083652|NCT01488994|OG001|Outcome|BAX326 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
11083653|NCT01488994|OG000|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
11083654|NCT01488994|EG000|Reported Event|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
11083655|NCT01489020|BG000|Baseline|Group A Active|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11083656|NCT01489020|BG001|Baseline|Group B Active|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11083657|NCT01489020|BG002|Baseline|Group C Active|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11083658|NCT01489020|BG003|Baseline|Group A Placebo|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~Subcutaneous depot placebo"
11083659|NCT01489020|BG004|Baseline|Group B Placebo|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous depot placebo"
11083660|NCT01489020|BG005|Baseline|Group C Placebo|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous depot placebo"
11083661|NCT01489020|BG006|Baseline|Total|Total of all reporting groups
11083662|NCT01489020|FG000|Participant Flow|Group A Active|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083663|NCT01489020|FG001|Participant Flow|Group A Placebo|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083664|NCT01489020|FG002|Participant Flow|Group B Active|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083665|NCT01489020|FG003|Participant Flow|Group B Placebo|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11092019|NCT01537081|BG002|Baseline|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
11092020|NCT01537081|BG003|Baseline|Total|Total of all reporting groups
11227699|NCT02385526|BG000|Baseline|Group A|Vagus Nerve Stimulation Therapy Standard Titration method
11083666|NCT01489020|FG004|Participant Flow|Group C Active|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083667|NCT01489020|FG005|Participant Flow|Group C Placebo|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083668|NCT01489020|OG000|Outcome|Group A Active|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11083669|NCT01489020|OG001|Outcome|Group B Active|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11083670|NCT01489020|OG002|Outcome|Group C Active|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11083671|NCT01489020|OG003|Outcome|Group A Placebo|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous depot placebo"
11083672|NCT01489020|OG004|Outcome|Group B Placebo|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous depot placebo"
11083673|NCT01489020|OG005|Outcome|Group C Placebo|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous depot placebo"
11083674|NCT01489020|OG000|Outcome|Group A Active|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083675|NCT01489020|OG001|Outcome|Group A Placebo|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083676|NCT01489020|OG002|Outcome|Group B Active|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083677|NCT01489020|OG003|Outcome|Group B Placebo|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083678|NCT01489020|OG004|Outcome|Group C Active|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083679|NCT01489020|OG005|Outcome|Group C Placebo|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)"
11083680|NCT01489020|EG000|Reported Event|Group A Active|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11083681|NCT01489020|EG001|Reported Event|Group B Active|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11227700|NCT02385526|BG001|Baseline|Group B|"Vagus Nerve Stimulation Therapy Alternate Titration 1~Alternate titration method that combined methods from Group A and Group C."
11083682|NCT01489020|EG002|Reported Event|Group C Active|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo"
11083683|NCT01489020|EG003|Reported Event|Group A Placebo|"6 administrations and 5 weeks duration~Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.~subcutaneous depot placebo"
11083684|NCT01489020|EG004|Reported Event|Group B Placebo|"8 administrations and 7 weeks duration~Vial 1: 0.2 ml at 1 week intervals~Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals~Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals~subcutaneous depot placebo"
11083685|NCT01489020|EG005|Reported Event|Group C Placebo|"8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.~Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval~Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval~Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval~Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval~subcutaneous depot placebo"
11083686|NCT01489111|BG000|Baseline|NNC 0129-0000-1003 (Turoctocog Alfa Pegol)|Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859.
11083687|NCT01489111|FG000|Participant Flow|NNC 0129-0000-1003 (Turoctocog Alfa Pegol)|Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859.
11083688|NCT01489111|OG000|Outcome|NNC 0129-0000-1003 (Turoctocog Alfa Pegol)|Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859.
11083689|NCT01489111|EG000|Reported Event|NNC 0129-0000-1003 (Turoctocog Alfa Pegol)|Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859.
11083690|NCT01489189|BG000|Baseline|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
11083691|NCT01489189|BG001|Baseline|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
11083692|NCT01489189|BG002|Baseline|Total|Total of all reporting groups
11083693|NCT01489189|FG000|Participant Flow|Anti-VEGF+Deferred PRP|"Anti vascular endothelial growth factor (Anti-VEGF). Panretinal photocoagulation (PRP). Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
11083694|NCT01489189|FG001|Participant Flow|Prompt PRP|"Panretinal Photocoagulation (PRP). PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
11357491|NCT03756883|FG001|Participant Flow|Reference|"ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder~Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation~Dose: 1 inhalation twice daily"
11083695|NCT01489189|OG000|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
11083696|NCT01489189|OG001|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
11083697|NCT01489189|EG000|Reported Event|Bilateral Participants|Participants with one eye enrolled in each arm of the study.
11083698|NCT01489189|EG001|Reported Event|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
11083699|NCT01489189|EG002|Reported Event|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
11083700|NCT01489254|BG000|Baseline|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
11083701|NCT01489254|BG001|Baseline|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
11083702|NCT01489254|BG002|Baseline|Placebo|Placebo (daily) for 9 months
11083703|NCT01489254|BG003|Baseline|Total|Total of all reporting groups
11083704|NCT01489254|FG000|Participant Flow|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
11083705|NCT01489254|FG001|Participant Flow|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
11083706|NCT01489254|FG002|Participant Flow|Placebo|Placebo (daily) for 9 months
11083707|NCT01489254|FG003|Participant Flow|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
11083708|NCT01489254|OG000|Outcome|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
11083709|NCT01489254|OG001|Outcome|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
11083710|NCT01489254|OG002|Outcome|Placebo|Placebo (daily) for 9 months
11083711|NCT01489254|EG000|Reported Event|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months, double-blind
11083712|NCT01489254|EG001|Reported Event|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months, double-blind
11083713|NCT01489254|EG002|Reported Event|Placebo|Placebo (daily) for 9 months, double-blind
11083714|NCT01489254|EG003|Reported Event|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
11083715|NCT01489358|BG000|Baseline|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083716|NCT01489358|BG001|Baseline|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083717|NCT01489358|BG002|Baseline|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083718|NCT01489358|BG003|Baseline|Total|Total of all reporting groups
11083719|NCT01489358|FG000|Participant Flow|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083720|NCT01489358|FG001|Participant Flow|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083721|NCT01489358|FG002|Participant Flow|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083722|NCT01489358|OG000|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083723|NCT01489358|OG001|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083724|NCT01489358|OG002|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083725|NCT01489358|EG000|Reported Event|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083726|NCT01489358|EG001|Reported Event|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083727|NCT01489358|EG002|Reported Event|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
11083728|NCT01489527|BG000|Baseline|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
11083729|NCT01489527|BG001|Baseline|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
11083730|NCT01489527|BG002|Baseline|Total|Total of all reporting groups
11083731|NCT01489527|FG000|Participant Flow|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
11083732|NCT01489527|FG001|Participant Flow|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
11083733|NCT01489527|OG000|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
11083734|NCT01489527|OG001|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
11083735|NCT01489527|EG000|Reported Event|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
11083736|NCT01489527|EG001|Reported Event|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
11357492|NCT03756883|FG002|Participant Flow|Placebo|"Placebo~Placebo Inhalation Powder: No active content~Dose: 1 inhalation twice daily"
11083737|NCT01489579|BG000|Baseline|BST Counseling Group|"The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources (Ready to quit patient handout. Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service: The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counse"
11083738|NCT01489579|BG001|Baseline|Usual Care Group|Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations. Usual Care: Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendatio
11083739|NCT01489579|BG002|Baseline|Total|Total of all reporting groups
11083740|NCT01489579|FG000|Participant Flow|Usual Care Group|Pharmacists randomized to Usual Care will continue to provide interventions/procedures according to usual care practices. Interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists randomized to Usual Care were asked to continue their current approach for tobacco cessation
11083741|NCT01489579|FG001|Participant Flow|BST Counseling Group|The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources
11083742|NCT01489579|OG000|Outcome|BST Counseling Group|The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources
11083743|NCT01489579|OG001|Outcome|Usual Care Group|Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
11083744|NCT01489579|OG001|Outcome|Usual Care Group|Pharmacists randomized to Usual Care will continue to provide interventions/procedures according to usual care practices. Interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists randomized to Usual Care were asked to continue their current approach for tobacco cessation
11083745|NCT01489579|OG001|Outcome|Usual Care Group|The study arms were balanced on baseline characteristics except for the control arm having a higher median chronic disease score (P = 0.013) Sixteen subjects (9 and 7 in the control and intervention arms, respectively) did not complete the follow-up tele- phone survey, resulting in 104 subjects (47 and 57 in the control and intervention arm, respectively) available for the survey-based outcome analyses. Cigarettes were the predominate type of tobacco used. Fewer than half of the subjects reported ''Yes'' to baseline readiness to quit in the next 30 days. There were no statistically significant differences identified in the primary (P = 0.804) or secondary outcomes (all P > 0.05)
11083746|NCT01489579|EG000|Reported Event|BST Counseling Group|The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources. AE's captured for patients who obtained lab data and had contact with clinical Pharmacist (120)
11083747|NCT01489579|EG001|Reported Event|Usual Care Group|Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations. AE's captured for patients who obtained lab data and had contact with clinical Pharmacist (120)
11083748|NCT01489670|BG000|Baseline|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
11083749|NCT01489670|FG000|Participant Flow|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
11083750|NCT01489670|OG000|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
11083751|NCT01489670|EG000|Reported Event|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
11083752|NCT01489826|BG000|Baseline|Dexanabinol Dose Escalation - Cohort 1|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
11083753|NCT01489826|BG001|Baseline|Dexanabinol Dose Escalation - Cohort 2|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
11083754|NCT01489826|BG002|Baseline|Dexanabinol Dose Escalation - Cohort 3|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
11083755|NCT01489826|BG003|Baseline|Dexanabinol Dose Escalation - Cohort 4|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
11083756|NCT01489826|BG004|Baseline|Dexanabinol Dose Escalation - Cohort 5|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
11083757|NCT01489826|BG005|Baseline|Dexanabinol Dose Escalation - Cohort 6|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
11083758|NCT01489826|BG006|Baseline|Dexanabinol Dose Escalation - Cohort 7|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
11083759|NCT01489826|BG007|Baseline|Dexanabinol Dose Escalation - Cohort 8|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
11083760|NCT01489826|BG008|Baseline|Dexanabinol Expansion Phase|Open label, expansion phase to assess pharmacodynamics of dexanabinol in patients with advanced tumours at the MTD/MAD (30 mg/kg)
11083761|NCT01489826|BG009|Baseline|Total|Total of all reporting groups
11083762|NCT01489826|FG000|Participant Flow|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083763|NCT01489826|FG001|Participant Flow|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083764|NCT01489826|FG002|Participant Flow|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083765|NCT01489826|FG003|Participant Flow|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083766|NCT01489826|FG004|Participant Flow|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083767|NCT01489826|FG005|Participant Flow|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083768|NCT01489826|FG006|Participant Flow|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083769|NCT01489826|FG007|Participant Flow|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083770|NCT01489826|FG008|Participant Flow|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083771|NCT01489826|OG000|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083772|NCT01489826|OG001|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11357493|NCT03756883|OG000|Outcome|Test|"Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg~Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation~Dose: 1 inhalation twice daily"
11083773|NCT01489826|OG002|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083774|NCT01489826|OG003|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083775|NCT01489826|OG004|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083776|NCT01489826|OG005|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083777|NCT01489826|OG006|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083778|NCT01489826|OG007|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083779|NCT01489826|OG008|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083780|NCT01489826|OG002|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083781|NCT01489826|OG003|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083782|NCT01489826|OG004|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083783|NCT01489826|OG005|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083784|NCT01489826|OG006|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083785|NCT01489826|OG003|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083786|NCT01489826|OG004|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083787|NCT01489826|OG005|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11227701|NCT02385526|BG002|Baseline|Group C|"Vagus Nerve Stimulation Therapy Alternate Titration 2~Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction."
11227702|NCT02385526|BG003|Baseline|Total|Total of all reporting groups
11227703|NCT02385526|FG000|Participant Flow|Group A|Vagus Nerve Stimulation Therapy Standard Titration method
11227704|NCT02385526|FG001|Participant Flow|Group B|"Vagus Nerve Stimulation Therapy Alternate Titration 1~Alternate titration method that combined methods from Group A and Group C."
11227705|NCT02385526|FG002|Participant Flow|Group C|"Vagus Nerve Stimulation Therapy Alternate Titration 2~Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction."
11083788|NCT01489826|EG000|Reported Event|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083789|NCT01489826|EG001|Reported Event|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083790|NCT01489826|EG002|Reported Event|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083791|NCT01489826|EG003|Reported Event|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083792|NCT01489826|EG004|Reported Event|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083793|NCT01489826|EG005|Reported Event|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11227706|NCT02385526|OG000|Outcome|Group A|Vagus Nerve Stimulation Therapy Standard Titration method
11227707|NCT02385526|OG001|Outcome|Group B|"Vagus Nerve Stimulation Therapy Alternate Titration 1~Alternate titration method that combined methods from Group A and Group C."
11083794|NCT01489826|EG006|Reported Event|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083795|NCT01489826|EG007|Reported Event|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083796|NCT01489826|EG008|Reported Event|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
11083797|NCT01489891|BG000|Baseline|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
11083798|NCT01489891|BG001|Baseline|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
11083799|NCT01489891|BG002|Baseline|Total|Total of all reporting groups
11083800|NCT01489891|FG000|Participant Flow|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
11083801|NCT01489891|FG001|Participant Flow|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
11083802|NCT01489891|OG000|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
11227708|NCT02385526|OG002|Outcome|Group C|"Vagus Nerve Stimulation Therapy Alternate Titration 2~Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction."
11227709|NCT02385526|EG000|Reported Event|Group A|Vagus Nerve Stimulation Therapy Standard Titration method
11227710|NCT02385526|EG001|Reported Event|Group B|"Vagus Nerve Stimulation Therapy Alternate Titration 1~Alternate titration method that combined methods from Group A and Group C."
11227711|NCT02385526|EG002|Reported Event|Group C|"Vagus Nerve Stimulation Therapy Alternate Titration 2~Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction."
11227712|NCT02385669|BG000|Baseline|6MHP and Ipilimumab|"The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 43, 64, and 85. All peptide vaccines are administered intradermally and subcutaneously.~Ipilimumab will be administered in accord with the official prescribing information: 3 mg/kg intravenously once every 3 weeks, for 4 doses. Ipilimumab will be administered on days 1, 22, 43, and 64.~Ipilimumab: Checkpoint blockade inhibitor~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides"
11227713|NCT02385669|FG000|Participant Flow|6MHP and Ipilimumab|"The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 43, 64, and 85. All peptide vaccines are administered intradermally and subcutaneously.~Ipilimumab will be administered in accord with the official prescribing information: 3 mg/kg intravenously once every 3 weeks, for 4 doses. Ipilimumab will be administered on days 1, 22, 43, and 64.~Ipilimumab: Checkpoint blockade inhibitor~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides"
11233773|NCT02431260|BG004|Baseline|Part 1 / Treatment Group A: 22.5 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11357494|NCT03756883|OG001|Outcome|Reference|"ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder~Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation~Dose: 1 inhalation twice daily"
11083803|NCT01489891|OG001|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
11083804|NCT01489891|EG000|Reported Event|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
11083805|NCT01489891|EG001|Reported Event|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
11083806|NCT01489956|BG000|Baseline|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
11083807|NCT01489956|BG001|Baseline|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
11083808|NCT01489956|BG002|Baseline|Total|Total of all reporting groups
11083809|NCT01489956|FG000|Participant Flow|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
11083810|NCT01489956|FG001|Participant Flow|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
11083811|NCT01489956|FG002|Participant Flow|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
11083812|NCT01489956|OG000|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
11083813|NCT01489956|OG001|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
11083814|NCT01489956|OG002|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
11083815|NCT01489956|EG000|Reported Event|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
11083816|NCT01489956|EG001|Reported Event|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
11083817|NCT01489956|EG002|Reported Event|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
11083818|NCT01489969|BG000|Baseline|Neu-P11 20mg|"Neu-P11 dose of 20 mg~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083819|NCT01489969|BG001|Baseline|Neu-P11 50mg|"Neu-P11 dose of 50 mg~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083820|NCT01489969|BG002|Baseline|Placebo|"matching placebo~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083821|NCT01489969|BG003|Baseline|Total|Total of all reporting groups
11083822|NCT01489969|FG000|Participant Flow|Neu-P11 20mg|"Neu-P11 dose of 20 mg~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083823|NCT01489969|FG001|Participant Flow|Neu-P11 50mg|"Neu-P11 dose of 50 mg~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083824|NCT01489969|FG002|Participant Flow|Placebo|"matching placebo~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083825|NCT01489969|OG000|Outcome|Neu-P11 20mg|"Neu-P11 dose of 20 mg~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083826|NCT01489969|OG001|Outcome|Neu-P11 50mg|"Neu-P11 dose of 50 mg~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083827|NCT01489969|OG002|Outcome|Placebo|"matching placebo~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083828|NCT01489969|EG000|Reported Event|Neu-P11 20mg|"Neu-P11 dose of 20 mg~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083829|NCT01489969|EG001|Reported Event|Neu-P11 50mg|"Neu-P11 dose of 50 mg~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11083830|NCT01489969|EG002|Reported Event|Placebo|"matching placebo~Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment"
11092021|NCT01537081|FG000|Participant Flow|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
11092022|NCT01537081|FG001|Participant Flow|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
11092023|NCT01537081|FG002|Participant Flow|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
11092024|NCT01537081|OG000|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
11092025|NCT01537081|OG001|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
11092026|NCT01537081|OG002|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
11092027|NCT01537081|OG000|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
11092028|NCT01537081|EG000|Reported Event|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
11092029|NCT01537081|EG001|Reported Event|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
11092030|NCT01537081|EG002|Reported Event|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
11092031|NCT01537120|BG000|Baseline|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
11092032|NCT01537120|FG000|Participant Flow|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
11092033|NCT01537120|OG000|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
11092034|NCT01537120|OG001|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
11092035|NCT01537120|EG000|Reported Event|Vildagliptin 50 mg|Vildagliptin tablets 50 mg twice daily for 12 weeks
11092036|NCT01537120|EG001|Reported Event|Placebo|Placebo tablets twice daily for 3 weeks
11092037|NCT01537133|BG000|Baseline|Atopic Asthmatics Treated With Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
11092038|NCT01537133|BG001|Baseline|Atopic Asthmatics Treated With Placebo|Placebo fluticasone (one puff, twice a day)
11092039|NCT01537133|BG002|Baseline|Atopic Non-asthmatics|
11092040|NCT01537133|BG003|Baseline|Healthy Control|
11092041|NCT01537133|BG004|Baseline|Total|Total of all reporting groups
11092042|NCT01537133|FG000|Participant Flow|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
11092043|NCT01537133|FG001|Participant Flow|Placebo|Placebo fluticasone (one puff, twice a day)
11092044|NCT01537133|FG002|Participant Flow|Healthy Control|
11092045|NCT01537133|FG003|Participant Flow|Atopic Non-asthmatics|
11092046|NCT01537133|OG000|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
11092047|NCT01537133|OG001|Outcome|Atopic Asthmatics Treated With Placebo|
11092048|NCT01537133|OG002|Outcome|Atopic Non-asthmatics|
11092049|NCT01537133|OG003|Outcome|Healthy Control|
11092050|NCT01537133|EG000|Reported Event|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
11092051|NCT01537133|EG001|Reported Event|Placebo|Placebo fluticasone (one puff, twice a day)
11092052|NCT01537185|BG000|Baseline|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11092053|NCT01537185|BG001|Baseline|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
11092054|NCT01537185|BG002|Baseline|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11092055|NCT01537185|BG003|Baseline|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11083831|NCT01490060|BG000|Baseline|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
11083832|NCT01490060|BG001|Baseline|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
11083833|NCT01490060|BG002|Baseline|Total|Total of all reporting groups
11083834|NCT01490060|FG000|Participant Flow|Arm A: Single Dose, Group 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
11083835|NCT01490060|FG001|Participant Flow|Arm A: Single Dose, Group 2|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
11083836|NCT01490060|FG002|Participant Flow|Arm B: Two Doses, Group 1|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
11083837|NCT01490060|FG003|Participant Flow|Arm B: Two Doses, Group 2|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
11083838|NCT01490060|OG000|Outcome|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
11083839|NCT01490060|OG001|Outcome|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
11083840|NCT01490060|OG002|Outcome|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
11083841|NCT01490060|EG000|Reported Event|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
11083842|NCT01490060|EG001|Reported Event|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
11083843|NCT01490060|EG002|Reported Event|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
11083844|NCT01490073|BG000|Baseline|Active Nitroglycerin Ointment|Insertion of nitroglycerin ointment: Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion
11083845|NCT01490073|BG001|Baseline|Placebo Ointment|Insertion of placebo ointment: Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion
11083846|NCT01490073|BG002|Baseline|Total|Total of all reporting groups
11083847|NCT01490073|FG000|Participant Flow|Active Nitroglycerin Ointment|Insertion of nitroglycerin ointment: Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion
11083848|NCT01490073|FG001|Participant Flow|Placebo Ointment|Insertion of placebo ointment: Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion
11083849|NCT01490073|OG000|Outcome|Active Nitroglycerin Ointment|Insertion of nitroglycerin ointment: Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion
11083850|NCT01490073|OG001|Outcome|Placebo Ointment|Insertion of placebo ointment: Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion
11083851|NCT01490073|EG000|Reported Event|Active Nitroglycerin Ointment|Insertion of nitroglycerin ointment: Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion
11083852|NCT01490073|EG001|Reported Event|Placebo Ointment|Insertion of placebo ointment: Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion
11083853|NCT01490086|BG000|Baseline|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
11083854|NCT01490086|BG001|Baseline|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
11083855|NCT01490086|BG002|Baseline|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
11083856|NCT01490086|BG003|Baseline|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
11083857|NCT01490086|BG004|Baseline|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
11083858|NCT01490086|BG005|Baseline|Total|Total of all reporting groups
11083859|NCT01490086|FG000|Participant Flow|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
11083860|NCT01490086|FG001|Participant Flow|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
11083861|NCT01490086|FG002|Participant Flow|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
11083862|NCT01490086|FG003|Participant Flow|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
11083863|NCT01490086|FG004|Participant Flow|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
11083864|NCT01490086|OG000|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
11083865|NCT01490086|OG001|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
11083866|NCT01490086|OG002|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
11083867|NCT01490086|OG003|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
11083868|NCT01490086|OG004|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
11083869|NCT01490086|EG000|Reported Event|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
11083870|NCT01490086|EG001|Reported Event|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
11083871|NCT01490086|EG002|Reported Event|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
11083872|NCT01490086|EG003|Reported Event|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
11083873|NCT01490086|EG004|Reported Event|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
11083874|NCT01490125|BG000|Baseline|All Participants|All participants who entered the study and were randomized to any of the 3 treatment combinations: QVA149 plus placebo to tiotropium; tiotropium plus placebo to QVA149 or placebo to QVA149 plus placebo to tiotropium.
11083875|NCT01490125|FG000|Participant Flow|QVA149+ Placebo+ Tiotropium|Participants were randomized to sequence QVA149 + placebo + tiotropium.
11083876|NCT01490125|FG001|Participant Flow|QVA149+ Tiotropium+ Placebo|Participants were randomized to sequence QVA149 + tiotropium + placebo.
11083877|NCT01490125|FG002|Participant Flow|Placebo + QVA149 + Tiotropium|Participants were randomized to sequence placebo + QVA149 + tiotropium
11083878|NCT01490125|FG003|Participant Flow|Placebo+ Tiotropium + QVA149|Participants were randomized to sequence placebo + tiotropium + QVA149
11083879|NCT01490125|FG004|Participant Flow|Tiotropium + QVA149+ Placebo|Participants were randomized to sequence tiotropium + QVA149 + placebo
11083880|NCT01490125|FG005|Participant Flow|Tiotropium + Placebo +QVA149|Participants were randomized to sequence tiotropium + placebo + QVA149
11083881|NCT01490125|OG000|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
11083882|NCT01490125|OG001|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
11083883|NCT01490125|OG002|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
11083884|NCT01490125|EG000|Reported Event|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
11083885|NCT01490125|EG001|Reported Event|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
11083886|NCT01490125|EG002|Reported Event|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
11083887|NCT01490151|BG000|Baseline|TTR Controller|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus."
11083888|NCT01490151|FG000|Participant Flow|TTR Controller|"The intervention will consist of using the Treat to Range (TTR) controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus."
11083889|NCT01490151|OG000|Outcome|Cohort A1 - Missed Bolus Meal|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal (Cohort A1) or a high glycemic index meal (Cohort A2) and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus (Cohort B)."
11083890|NCT01490151|OG001|Outcome|Cohort A2 - Missed Bolus Meal|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will have a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home."
11083891|NCT01490151|OG002|Outcome|Cohort B - Overbolus Meal|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will receive an insulin dose which will be 120% of their usual insulin bolus. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home."
11083892|NCT01490151|EG000|Reported Event|TTR Controller|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus."
11083893|NCT01490294|BG000|Baseline|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083894|NCT01490294|BG001|Baseline|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083895|NCT01490294|BG002|Baseline|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083896|NCT01490294|BG003|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083897|NCT01490294|BG004|Baseline|Total|Total of all reporting groups
11083898|NCT01490294|FG000|Participant Flow|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083899|NCT01490294|FG001|Participant Flow|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083900|NCT01490294|FG002|Participant Flow|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083901|NCT01490294|FG003|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11357495|NCT03756883|OG002|Outcome|Placebo|"Placebo~Placebo Inhalation Powder: No active content~Dose: 1 inhalation twice daily"
11083902|NCT01490294|OG000|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083903|NCT01490294|OG001|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083904|NCT01490294|OG002|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083905|NCT01490294|OG003|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083906|NCT01490294|EG000|Reported Event|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083907|NCT01490294|EG001|Reported Event|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083908|NCT01490294|EG002|Reported Event|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083909|NCT01490294|EG003|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
11083910|NCT01490359|BG000|Baseline|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
11083911|NCT01490359|BG001|Baseline|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
11083912|NCT01490359|BG002|Baseline|Total|Total of all reporting groups
11083913|NCT01490359|FG000|Participant Flow|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
11083914|NCT01490359|FG001|Participant Flow|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
11092056|NCT01537185|BG004|Baseline|Total|Total of all reporting groups
11092057|NCT01537185|FG000|Participant Flow|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11092058|NCT01537185|FG001|Participant Flow|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
11357496|NCT03756883|EG000|Reported Event|Test|"Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg~Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation~Dose: 1 inhalation twice daily"
11083915|NCT01490359|OG000|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
11083916|NCT01490359|OG001|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
11083917|NCT01490359|OG000|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
11083918|NCT01490359|EG000|Reported Event|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
11083919|NCT01490359|EG001|Reported Event|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
11083920|NCT01490450|BG000|Baseline|Placebo|Subcutaneous, every 4 weeks for 24 weeks
11083921|NCT01490450|BG001|Baseline|Clazakizumab (25mg)|Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
11083922|NCT01490450|BG002|Baseline|Clazakizumab (100mg)|Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
11083923|NCT01490450|BG003|Baseline|Clazakizumab (200mg)|Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
11083924|NCT01490450|BG004|Baseline|Total|Total of all reporting groups
11083925|NCT01490450|FG000|Participant Flow|Placebo|Subcutaneous, every 4 weeks for 24 weeks
11083926|NCT01490450|FG001|Participant Flow|Clazakizumab (25mg)|Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
11083927|NCT01490450|FG002|Participant Flow|Clazakizumab (100mg)|Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
11083928|NCT01490450|FG003|Participant Flow|Clazakizumab (200mg)|Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
11083929|NCT01490450|OG000|Outcome|Placebo|Subcutaneous, every 4 weeks for 24 weeks
11083930|NCT01490450|OG001|Outcome|Clazakizumab (25mg)|Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
11083931|NCT01490450|OG002|Outcome|Clazakizumab (100mg)|Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
11083932|NCT01490450|OG003|Outcome|Clazakizumab (200mg)|Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
11083933|NCT01490450|OG000|Outcome|Clazakizumab (25mg)|Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
11083934|NCT01490450|OG001|Outcome|Clazakizumab (100mg)|Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
11083935|NCT01490450|OG002|Outcome|Clazakizumab (200mg)|Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
11083936|NCT01490450|EG000|Reported Event|Placebo|Subcutaneous, every 4 weeks for 24 weeks
11083937|NCT01490450|EG001|Reported Event|Clazakizumab (25mg)|Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
11083938|NCT01490450|EG002|Reported Event|Clazakizumab (100mg)|Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
11083939|NCT01490450|EG003|Reported Event|Clazakizumab (200mg)|Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
11083940|NCT01490580|BG000|Baseline|Atropine Atracurium Sufentanil|
11083941|NCT01490580|BG001|Baseline|Atropine Propofol|
11083942|NCT01490580|BG002|Baseline|Total|Total of all reporting groups
11083943|NCT01490580|FG000|Participant Flow|Atropine Atracurium Sufentanil|"n=82 allocated to atropine+atracurium+sufentanil~n=80 received allocated intervention~n=2 did not receive allocated intervention~n=1 never intubated~n=1 received another premedication~82 included in final analysis"
11083944|NCT01490580|FG001|Participant Flow|Atropine Propofol|"n=91 allocated to atropine+propofol~n= 2 excluded for lack of consent~n=83 received allocated intervention~n=6 did not receive allocated intervention~n=2 never intubated~n=4 received another premedication~89 included in final analysis"
11083945|NCT01490580|OG000|Outcome|Atropine Atracurium Sufentanil|
11083946|NCT01490580|OG001|Outcome|Atropine Propofol|
11083947|NCT01490580|OG000|Outcome|Atropine + Propofol|atropine+ propofol: Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg
11083948|NCT01490580|OG001|Outcome|Atropine + Atracurium + Sufentanil|atropine + atracurium + sufentanil: Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g
11083949|NCT01490580|OG000|Outcome|"Atropine Atracurium Sufentanil as Treated Population"|"n=81~n=79 Received intervention as randomized~n=2 Allocated to atropine + propofol but did not receive propofol and received atracurium + sufentanil as open-label drug"
11083950|NCT01490580|OG001|Outcome|"Atropine Propofol as Treated Population"|"n=85~n=83 Received intervention as randomized~n=1 Allocated to atropine + atracurium + sufentanil but received propofol as open-label drug~n=1 Allocated to atropine + propofol but did not receive intervention as randomized, received open-label atropine + propofol"
11083951|NCT01490580|EG000|Reported Event|Atropine + Propofol|atropine+ propofol: Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg
11083952|NCT01490580|EG001|Reported Event|Atropine + Atracurium + Sufentanil|atropine + atracurium + sufentanil: Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g
11083953|NCT01490632|BG000|Baseline|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083954|NCT01490632|BG001|Baseline|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083955|NCT01490632|BG002|Baseline|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083956|NCT01490632|BG003|Baseline|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
11083957|NCT01490632|BG004|Baseline|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
11083958|NCT01490632|BG005|Baseline|Total|Total of all reporting groups
11083959|NCT01490632|FG000|Participant Flow|Part A: Placebo|Placebo administered orally (PO) once daily (QD) for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083960|NCT01490632|FG001|Participant Flow|Part A: Baricitinib 2 mg|Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083961|NCT01490632|FG002|Participant Flow|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083962|NCT01490632|FG003|Participant Flow|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
11083963|NCT01490632|FG004|Participant Flow|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
11083964|NCT01490632|FG005|Participant Flow|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
11083965|NCT01490632|FG006|Participant Flow|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
11083966|NCT01490632|FG007|Participant Flow|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
11083967|NCT01490632|FG008|Participant Flow|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
11083968|NCT01490632|FG009|Participant Flow|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
11083969|NCT01490632|FG010|Participant Flow|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
11083970|NCT01490632|FG011|Participant Flow|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
11083971|NCT01490632|FG012|Participant Flow|Part C: Responder - Low Dose to Placebo|Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
11083972|NCT01490632|FG013|Participant Flow|Part C: Responder - Low Dose to ½ Low Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
11083973|NCT01490632|FG014|Participant Flow|Part C: Responder - High Dose to Placebo|Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
11083974|NCT01490632|FG015|Participant Flow|Part C: Responder - High Dose to Low Dose|Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
11083975|NCT01490632|FG016|Participant Flow|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
11083976|NCT01490632|FG017|Participant Flow|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
11083977|NCT01490632|FG018|Participant Flow|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
11083978|NCT01490632|FG019|Participant Flow|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
11083979|NCT01490632|OG000|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083980|NCT01490632|OG001|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083981|NCT01490632|OG002|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11083982|NCT01490632|OG003|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
11083983|NCT01490632|OG004|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
11083984|NCT01490632|OG000|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
11083985|NCT01490632|OG001|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
11083986|NCT01490632|OG002|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
11083987|NCT01490632|OG003|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
11083988|NCT01490632|OG004|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
11083989|NCT01490632|OG005|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
11083990|NCT01490632|OG006|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
11083991|NCT01490632|OG000|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
11083992|NCT01490632|OG001|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
11083993|NCT01490632|OG002|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
11083994|NCT01490632|OG003|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
11083995|NCT01490632|OG003|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
11083996|NCT01490632|OG001|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks
11083997|NCT01490632|OG002|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
11083998|NCT01490632|OG000|Outcome|Part C: Responder - Low Dose to Placebo|Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
11083999|NCT01490632|OG001|Outcome|Part C: Responder - Low Dose to ½ Low Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
11084000|NCT01490632|OG002|Outcome|Part C: Responder - High Dose to Placebo|Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
11084001|NCT01490632|OG003|Outcome|Part C: Responder - High Dose to Low Dose|Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
11084002|NCT01490632|OG000|Outcome|Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11084003|NCT01490632|OG001|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11084004|NCT01490632|OG002|Outcome|Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
11084005|NCT01490632|OG003|Outcome|Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
11084006|NCT01490632|OG000|Outcome|Baricitinib 2 mg|Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11084007|NCT01490632|EG000|Reported Event|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11084008|NCT01490632|EG001|Reported Event|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11092059|NCT01537185|FG002|Participant Flow|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
11084009|NCT01490632|EG002|Reported Event|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
11084010|NCT01490632|EG003|Reported Event|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
11084011|NCT01490632|EG004|Reported Event|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
11084012|NCT01490632|EG005|Reported Event|Part B: Placebo|Placebo PO QD maintained on placebo PO QD.
11084013|NCT01490632|EG006|Reported Event|Part B: Low Dose|"All participants in the following groups (as described in the Participant Flow):~Responder Low Dose~Partial Responder Low Dose to Low Dose groups."
11084014|NCT01490632|EG007|Reported Event|Part B: High Dose|"All participants in the following groups (as described in the Participant Flow):~Responder High Dose~Partial and Non-responder Placebo to High Dose~Partial and Non-responder Low Dose to High Dose~Partial and Non-responder High Dose to High Dose"
11084015|NCT01490632|EG008|Reported Event|Part C: Placebo|All placebo participant groups after study drug re-randomized.
11084016|NCT01490632|EG009|Reported Event|Part C: Baricitinib|All baricitinib participant groups after study drug re-randomized to various doses.
11084017|NCT01490632|EG010|Reported Event|Part D: All Baricitinib Doses|All participant dosages following baricitinib retreatment with Part B efficacious dose for 52 weeks.
11084018|NCT01490632|EG011|Reported Event|Follow-up: Always Placebo|Participants in follow-up with exposure to placebo only during the study. No placebo received during follow-up.
11084019|NCT01490632|EG012|Reported Event|Follow-up: Ever Used Baricitinib|Participants in follow-up with exposure to any dose of baricitinib during study. No baricitinib received during follow-up.
11084020|NCT01490684|BG000|Baseline|The Whole Cohort|The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
11084021|NCT01490684|FG000|Participant Flow|The Whole Cohort|The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
11084022|NCT01490684|OG000|Outcome|The Whole Cohort|The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
11084023|NCT01490684|EG000|Reported Event|The Whole Cohort|The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
11084024|NCT01490697|BG000|Baseline|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
11084025|NCT01490697|BG001|Baseline|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
11084026|NCT01490697|BG002|Baseline|Total|Total of all reporting groups
11084027|NCT01490697|FG000|Participant Flow|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
11084028|NCT01490697|FG001|Participant Flow|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
11084029|NCT01490697|OG000|Outcome|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
11084030|NCT01490697|OG001|Outcome|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
11084031|NCT01490697|EG000|Reported Event|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
11084032|NCT01490697|EG001|Reported Event|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
11084033|NCT01490723|BG000|Baseline|Yttrium-90 Ibritumomab + Chemo|Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
11084034|NCT01490723|FG000|Participant Flow|Yttrium-90 Ibritumomab + Chemo|Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
11092060|NCT01537185|FG003|Participant Flow|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
11092061|NCT01537185|OG000|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11092062|NCT01537185|OG001|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
11084035|NCT01490723|OG000|Outcome|Yttrium-90 Ibritumomab + Chemo|Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
11084036|NCT01490723|EG000|Reported Event|Yttrium-90 Ibritumomab + Chemo|Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
11084037|NCT01490788|BG000|Baseline|All Study Participants|All subjects that were randomized to receive all three treatments.
11084038|NCT01490788|FG000|Participant Flow|Treatment A First, Then B, Then C|Single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions)
11084039|NCT01490788|FG001|Participant Flow|Treatment A First, Then C, Then B|Single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions)
11084040|NCT01490788|FG002|Participant Flow|Treatment B First, Then A, Then C|Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions)
11084041|NCT01490788|FG003|Participant Flow|Treatment B First, Then C, Then A|Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions)
11084042|NCT01490788|FG004|Participant Flow|Treatment C First, Then A, Then B|Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions)
11084043|NCT01490788|FG005|Participant Flow|Treatment C First, Then B, Then A|Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions)
11084044|NCT01490788|OG000|Outcome|Treatment A|All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study.
11084045|NCT01490788|OG001|Outcome|Treatment B|All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study.
11357497|NCT03756883|EG001|Reported Event|Reference|"ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder~Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation~Dose: 1 inhalation twice daily"
11084046|NCT01490788|OG002|Outcome|Treatment C|All study subject who were administered one TNX-102 2.4 mg, gelcap under fed conditions during the course of the study.
11084047|NCT01490788|EG000|Reported Event|Treatment A|All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study.
11084048|NCT01490788|EG001|Reported Event|Treatment B|All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study.
11084049|NCT01490788|EG002|Reported Event|Treatment C|All study subject who were administered one TNX-102 2.4 mg gelcap under fed conditions during the course of the study.
11084050|NCT01490814|BG000|Baseline|Cryoballoon Ablation|Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
11084051|NCT01490814|BG001|Baseline|Radiofrequency Ablation|Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
11084052|NCT01490814|BG002|Baseline|Total|Total of all reporting groups
11084053|NCT01490814|FG000|Participant Flow|Cryoballoon Ablation|Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
11084054|NCT01490814|FG001|Participant Flow|Radiofrequency Ablation|Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
11084055|NCT01490814|OG000|Outcome|Cryoballoon Ablation|Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
11084056|NCT01490814|OG001|Outcome|Radiofrequency Ablation|Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
11084057|NCT01490814|EG000|Reported Event|Cryoballoon Ablation|Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
11084058|NCT01490814|EG001|Reported Event|Radiofrequency Ablation|Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
11084059|NCT01490840|BG000|Baseline|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
11084060|NCT01490840|BG001|Baseline|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
11084061|NCT01490840|BG002|Baseline|Total|Total of all reporting groups
11084062|NCT01490840|FG000|Participant Flow|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
11084063|NCT01490840|FG001|Participant Flow|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
11084064|NCT01490840|OG000|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
11084065|NCT01490840|OG001|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
11092063|NCT01537185|OG002|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
11092064|NCT01537185|OG003|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
11092065|NCT01537185|OG002|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11092066|NCT01537185|OG003|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11092067|NCT01537185|EG000|Reported Event|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11084066|NCT01490840|EG000|Reported Event|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
11084067|NCT01490840|EG001|Reported Event|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
11084068|NCT01490866|BG000|Baseline|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.~FOLFOX/bevacizumab:~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day (PO BID)"
11084069|NCT01490866|FG000|Participant Flow|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
11084070|NCT01490866|OG000|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
11084071|NCT01490866|OG000|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.~FOLFOX/bevacizumab:~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day (PO BID)"
11084072|NCT01490866|OG000|Outcome|FOLFOX/Bevacizumab|All patients who received at least one dose of FOLFOX/bevacizumab
11084073|NCT01490866|OG001|Outcome|Axitinib|All patients who received at least one dose of axitinib
11084074|NCT01490866|EG000|Reported Event|FOLFOX/Bevacizumab and Axitinib|
11084075|NCT01490892|BG000|Baseline|3D HI and SHI of UCA|"Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)~3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)"
11084076|NCT01490892|FG000|Participant Flow|3D HI and SHI of UCA|"Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)~3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)"
11084077|NCT01490892|OG000|Outcome|3D HI and SHI of UCA|"Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)~3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)"
11084078|NCT01490892|EG000|Reported Event|3D HI and SHI of UCA|"Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)~3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)"
11084079|NCT01490918|BG000|Baseline|Acarbose Placebo, Metformin, Sitagliptin|"The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week.~Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively"
11084080|NCT01490918|BG001|Baseline|Sitagliptin, Metformin, Acarbose|"The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)~Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively"
11092068|NCT01537185|EG001|Reported Event|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
11084081|NCT01490918|BG002|Baseline|Metformin Placebo, Sitagliptin, Acarbose|"The Metformin placebo should be changed into real Metformin from the 16th week.~Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively"
11084082|NCT01490918|BG003|Baseline|Total|Total of all reporting groups
11084083|NCT01490918|FG000|Participant Flow|Acarbose Placebo, Metformin, Sitagliptin|Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.
11084084|NCT01490918|FG001|Participant Flow|Sitagliptin, Metformin, Acarbose|Metformin and sitagliptin and acarbose treatment for 24 weeks.
11084085|NCT01490918|FG002|Participant Flow|Metformin Placebo, Sitagliptin, Acarbose|Placebo and sitagliptin and acarbose treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks. The Metformin placebo should be changed into real Metformin from the 16th week.
11084086|NCT01490918|OG000|Outcome|Placebo+Metformin+Sitagliptin|Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
11084087|NCT01490918|OG001|Outcome|Sitagliptin+Metformin+Acarbose|Metformin and sitagliptin and acarbose treatment for 24 weeks.
11084088|NCT01490918|OG002|Outcome|Placebo+Sitagliptin+Acarbose|Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
11084089|NCT01490918|OG000|Outcome|Placebo+Metformin+Sitagliptin|Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.
11084090|NCT01490918|OG002|Outcome|Placebo+Sitagliptin+Acarbose|Placebo and sitagliptin and acarbose treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks. The Metformin placebo should be changed into real Metformin from the 16th week.
11233774|NCT02431260|BG005|Baseline|Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329|"Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.~Treatment Group A included any advanced solid tumor or lymphoma."
11084091|NCT01490918|OG002|Outcome|Placebo + Sitagliptin + Acarbose|Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
11084092|NCT01490918|OG002|Outcome|Placebo + Acarbose + Sitagliptin|Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
11357498|NCT03756883|EG002|Reported Event|Placebo|"Placebo~Placebo Inhalation Powder: No active content~Dose: 1 inhalation twice daily"
11084093|NCT01490918|EG000|Reported Event|Acarbose Placebo, Metformin, Sitagliptin|"The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week.~Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively"
11084094|NCT01490918|EG001|Reported Event|Sitagliptin, Metformin, Acarbose|"The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)~Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively"
11084095|NCT01490918|EG002|Reported Event|Metformin Placebo, Sitagliptin, Acarbose|"The Metformin placebo should be changed into real Metformin from the 16th week.~Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively"
11084096|NCT01490931|BG000|Baseline|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
11084097|NCT01490931|FG000|Participant Flow|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
11084098|NCT01490931|OG000|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
11084099|NCT01490931|EG000|Reported Event|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
11084100|NCT01491022|BG000|Baseline|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
11084101|NCT01491022|BG001|Baseline|Placebo Then Ampyra|Placebo for 4 weeks followed by 2 weeks washout followed by Ampyra 10 mg po bid for 4 weeks
11084102|NCT01491022|BG002|Baseline|Total|Total of all reporting groups
11084103|NCT01491022|FG000|Participant Flow|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
11084104|NCT01491022|FG001|Participant Flow|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
11084105|NCT01491022|OG000|Outcome|Ampyra|"Ampyra 10 mg po BID~Dalfampridine: 10 mg po bid for 4 weeks"
11084106|NCT01491022|OG001|Outcome|Placebo|placebo: placebo
11084107|NCT01491022|OG000|Outcome|Ampyra|"Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks~Ampyra first, then Placebo: 10 mg po bid for 4 weeks followed by placebo 4 weeks."
11084108|NCT01491022|OG001|Outcome|Placebo|"placebo 4 weeks followed by Ampyra 10 mg po BID~placebo first, then Ampyra: placebo"
11084109|NCT01491022|OG000|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
11233775|NCT02431260|BG006|Baseline|Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11084110|NCT01491022|OG001|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
11084111|NCT01491022|EG000|Reported Event|Ampyra|"Ampyra 10 mg po BID~Dalfampridine: 10 mg po bid for 4 weeks"
11084112|NCT01491022|EG001|Reported Event|Placebo|placebo: placebo
11084113|NCT01491035|BG000|Baseline|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
11084114|NCT01491035|BG001|Baseline|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
11084115|NCT01491035|BG002|Baseline|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
11084116|NCT01491035|BG003|Baseline|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
11084117|NCT01491035|BG004|Baseline|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
11084118|NCT01491035|BG005|Baseline|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
11084119|NCT01491035|BG006|Baseline|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
11084120|NCT01491035|BG007|Baseline|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
11084121|NCT01491035|BG008|Baseline|Total|Total of all reporting groups
11084122|NCT01491035|FG000|Participant Flow|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
11084123|NCT01491035|FG001|Participant Flow|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
11084124|NCT01491035|FG002|Participant Flow|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
11084125|NCT01491035|FG003|Participant Flow|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
11084126|NCT01491035|FG004|Participant Flow|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
11084127|NCT01491035|FG005|Participant Flow|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
11084128|NCT01491035|FG006|Participant Flow|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
11084129|NCT01491035|FG007|Participant Flow|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
11084130|NCT01491035|OG000|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
11084131|NCT01491035|OG001|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
11084132|NCT01491035|OG002|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
11084133|NCT01491035|OG003|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
11084134|NCT01491035|OG004|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
11084135|NCT01491035|OG005|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
11084136|NCT01491035|OG006|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
11084137|NCT01491035|OG007|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
11084138|NCT01491035|EG000|Reported Event|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
11084139|NCT01491035|EG001|Reported Event|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
11084140|NCT01491035|EG002|Reported Event|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
11084141|NCT01491035|EG003|Reported Event|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
11084142|NCT01491035|EG004|Reported Event|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
11084143|NCT01491035|EG005|Reported Event|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
11084144|NCT01491035|EG006|Reported Event|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
11084145|NCT01491035|EG007|Reported Event|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
11084146|NCT01491113|BG000|Baseline|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
11092069|NCT01537185|EG002|Reported Event|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11092070|NCT01537185|EG003|Reported Event|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
11084147|NCT01491113|BG001|Baseline|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
11084148|NCT01491113|BG002|Baseline|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
11084149|NCT01491113|BG003|Baseline|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
11084150|NCT01491113|BG004|Baseline|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
11084151|NCT01491113|BG005|Baseline|Total|Total of all reporting groups
11084152|NCT01491113|FG000|Participant Flow|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
11084153|NCT01491113|FG001|Participant Flow|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
11084154|NCT01491113|FG002|Participant Flow|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
11084155|NCT01491113|FG003|Participant Flow|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
11084156|NCT01491113|FG004|Participant Flow|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
11084157|NCT01491113|OG000|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
11084158|NCT01491113|OG001|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
11084159|NCT01491113|OG002|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
11084160|NCT01491113|OG003|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
11084161|NCT01491113|OG000|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
11084162|NCT01491113|OG000|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
11084163|NCT01491113|OG000|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK) analysis: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
11084164|NCT01491113|EG000|Reported Event|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
11084165|NCT01491113|EG001|Reported Event|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
11084166|NCT01491113|EG002|Reported Event|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
11092071|NCT01537198|BG000|Baseline|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.
11084167|NCT01491113|EG003|Reported Event|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
11084168|NCT01491113|EG004|Reported Event|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
11084169|NCT01491178|BG000|Baseline|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
11084170|NCT01491178|FG000|Participant Flow|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
11084171|NCT01491178|OG000|Outcome|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
11084172|NCT01491178|EG000|Reported Event|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
11084173|NCT01491490|BG000|Baseline|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
11084174|NCT01491490|BG001|Baseline|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
11084175|NCT01491490|BG002|Baseline|Total|Total of all reporting groups
11084176|NCT01491490|FG000|Participant Flow|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
11084177|NCT01491490|FG001|Participant Flow|Placebo|Taken as 6 capsules, matched to taste and look like the active study medication.
11084178|NCT01491490|OG000|Outcome|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
11084179|NCT01491490|OG001|Outcome|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
11084180|NCT01491490|EG000|Reported Event|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
11084181|NCT01491490|EG001|Reported Event|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
11084182|NCT01491607|BG000|Baseline|BioThrax - Site 01|Subjects from Site 01 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
11084183|NCT01491607|BG001|Baseline|BioThrax - Site 02|Subjects from Site 02 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
11084184|NCT01491607|BG002|Baseline|BioThrax - Site 03|Subjects from Site 03 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
11084185|NCT01491607|BG003|Baseline|BioThrax - Site 04|Subjects from Site 04 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
11084186|NCT01491607|BG004|Baseline|Total|Total of all reporting groups
11084187|NCT01491607|FG000|Participant Flow|BioThrax|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
11084188|NCT01491607|OG000|Outcome|BioThrax|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
11084189|NCT01491607|OG001|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
11084190|NCT01491607|OG002|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
11084191|NCT01491607|OG003|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
11084192|NCT01491607|OG004|Outcome|BioThrax- > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
11084193|NCT01491607|OG005|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
11084194|NCT01491607|OG006|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
11084195|NCT01491607|OG007|Outcome|BioThrax - Site 01|Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
11084196|NCT01491607|OG008|Outcome|BioThrax - Site 02|Participants enrolled at Site 02 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
11084197|NCT01491607|OG009|Outcome|BioThrax - Site 03|Participants enrolled at Site 03 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
11084198|NCT01491607|OG010|Outcome|BioThrax - Site 04|Participants enrolled at Site 04 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
11084199|NCT01491607|OG000|Outcome|BioThrax - Day 70|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084200|NCT01491607|OG001|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084201|NCT01491607|OG002|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084202|NCT01491607|OG003|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084203|NCT01491607|OG004|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084204|NCT01491607|OG005|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084205|NCT01491607|OG006|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084206|NCT01491607|OG007|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084207|NCT01491607|OG008|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084208|NCT01491607|OG009|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084209|NCT01491607|OG010|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
11084210|NCT01491607|OG000|Outcome|BioThrax - Days 63-100 Immunogenicity|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084211|NCT01491607|OG001|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084212|NCT01491607|OG002|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084213|NCT01491607|OG003|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084214|NCT01491607|OG004|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084215|NCT01491607|OG005|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084216|NCT01491607|OG006|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11227714|NCT02385669|OG000|Outcome|6MHP and Ipilimumab|"The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 43, 64, and 85. All peptide vaccines are administered intradermally and subcutaneously.~Ipilimumab will be administered in accord with the official prescribing information: 3 mg/kg intravenously once every 3 weeks, for 4 doses. Ipilimumab will be administered on days 1, 22, 43, and 64.~Ipilimumab: Checkpoint blockade inhibitor~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides"
11233776|NCT02431260|BG007|Baseline|Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11084217|NCT01491607|OG007|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11227715|NCT02385669|EG000|Reported Event|6MHP and Ipilimumab|"The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 43, 64, and 85. All peptide vaccines are administered intradermally and subcutaneously.~Ipilimumab will be administered in accord with the official prescribing information: 3 mg/kg intravenously once every 3 weeks, for 4 doses. Ipilimumab will be administered on days 1, 22, 43, and 64.~Ipilimumab: Checkpoint blockade inhibitor~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides"
11227716|NCT02385708|BG000|Baseline|Standard of Care|"Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery~2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily"
11227717|NCT02385708|BG001|Baseline|Treatment Arm|"Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge~2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily"
11227718|NCT02385708|BG002|Baseline|Total|Total of all reporting groups
11227719|NCT02385708|FG000|Participant Flow|Standard of Care|"Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery~2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily"
11227720|NCT02385708|FG001|Participant Flow|Treatment Arm|"Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge~2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily"
11227721|NCT02385708|OG000|Outcome|Standard of Care|"Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery~2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily"
11227722|NCT02385708|OG001|Outcome|Treatment Arm|"Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge~2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily"
11227723|NCT02385708|EG000|Reported Event|Standard of Care|"Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery~2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily"
11227724|NCT02385708|EG001|Reported Event|Treatment Arm|"Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge~2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily"
11227725|NCT02385721|BG000|Baseline|Safety Set|Patients with essential hypertension who received Kanarb tablet® (fimasartan)
11227726|NCT02385721|FG000|Participant Flow|Safety Set|Patients with essential hypertension who received Kanarb tablet® (fimasartan)
11227727|NCT02385721|OG000|Outcome|Safety Set|Patients with essential hypertension who received Kanarb tablet® (fimasartan)
11227728|NCT02385721|EG000|Reported Event|Safety Set|Patients with essential hypertension who received Kanarb tablet® (fimasartan)
11227729|NCT02385799|BG000|Baseline|Sertraline Liquid Placebo|"The placebo will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid placebo once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid placebo once per day for a period of six months.~Sertraline Liquid Placebo: Liquid placebo given in parallel to active medication"
11227730|NCT02385799|BG001|Baseline|Sertraline Active Medication|"Liquid sertraline (20 mg/cc) will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid sertraline once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid sertraline once per day for a period of six months.~Sertraline: Active medication"
11227731|NCT02385799|BG002|Baseline|Total|Total of all reporting groups
11227732|NCT02385799|FG000|Participant Flow|Sertraline Liquid Placebo|"The placebo will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid placebo once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid placebo once per day for a period of six months.~Sertraline Liquid Placebo: Liquid placebo given in parallel to active medication"
11227733|NCT02385799|FG001|Participant Flow|Sertraline Active Medication|"Liquid sertraline (20 mg/cc) will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid sertraline once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid sertraline once per day for a period of six months.~Sertraline: Active medication"
11227734|NCT02385799|OG000|Outcome|Sertraline Liquid Placebo|"The placebo will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid placebo once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid placebo once per day for a period of six months.~Sertraline Liquid Placebo: Liquid placebo given in parallel to active medication"
11227735|NCT02385799|OG001|Outcome|Sertraline Active Medication|"Liquid sertraline (20 mg/cc) will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid sertraline once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid sertraline once per day for a period of six months.~Sertraline: Active medication"
11084218|NCT01491607|OG008|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084219|NCT01491607|OG009|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084220|NCT01491607|OG010|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
11084221|NCT01491607|OG000|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084222|NCT01491607|OG001|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084223|NCT01491607|OG002|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084224|NCT01491607|OG003|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084225|NCT01491607|OG004|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084226|NCT01491607|OG005|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084227|NCT01491607|OG006|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084228|NCT01491607|OG007|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084229|NCT01491607|OG008|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084230|NCT01491607|OG009|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084231|NCT01491607|OG010|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084232|NCT01491607|OG011|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084233|NCT01491607|OG012|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084234|NCT01491607|OG013|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084235|NCT01491607|OG014|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084236|NCT01491607|OG000|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084237|NCT01491607|OG001|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084238|NCT01491607|OG002|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084239|NCT01491607|OG003|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084240|NCT01491607|OG004|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084241|NCT01491607|OG005|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084242|NCT01491607|OG006|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084243|NCT01491607|OG007|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084244|NCT01491607|OG008|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084245|NCT01491607|OG009|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084246|NCT01491607|OG010|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084247|NCT01491607|OG011|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084248|NCT01491607|OG012|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084249|NCT01491607|OG013|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084250|NCT01491607|OG014|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
11084251|NCT01491607|EG000|Reported Event|ITT Population|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
11084252|NCT01491633|BG000|Baseline|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
11084253|NCT01491633|FG000|Participant Flow|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
11084254|NCT01491633|OG000|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
11084255|NCT01491633|EG000|Reported Event|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
11084256|NCT01491672|BG000|Baseline|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
11084257|NCT01491672|BG001|Baseline|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
11084258|NCT01491672|BG002|Baseline|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
11084259|NCT01491672|BG003|Baseline|Total|Total of all reporting groups
11084260|NCT01491672|FG000|Participant Flow|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
11084261|NCT01491672|FG001|Participant Flow|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
11084262|NCT01491672|FG002|Participant Flow|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
11084263|NCT01491672|OG000|Outcome|All Participants|All participants received RAD001 10 mg daily.
11084264|NCT01491672|OG000|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
11233777|NCT02431260|BG008|Baseline|Part 1 / Treatment Group A: 20 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11084265|NCT01491672|OG001|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
11084266|NCT01491672|OG002|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
11084267|NCT01491672|OG003|Outcome|All Participants|All participants received RAD001 10 mg daily.
11084268|NCT01491672|EG000|Reported Event|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
11084269|NCT01491672|EG001|Reported Event|Other Prior Anti VEGF|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
11084270|NCT01491672|EG002|Reported Event|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
11084271|NCT01491737|BG000|Baseline|Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
11084272|NCT01491737|BG001|Baseline|Arm B: Trastuzumab + AI +/- Chemotherapy|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
11084273|NCT01491737|BG002|Baseline|Total|Total of all reporting groups
11092072|NCT01537198|FG000|Participant Flow|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.
11084274|NCT01491737|FG000|Participant Flow|Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
11084275|NCT01491737|FG001|Participant Flow|Arm B: Trastuzumab + AI +/- Chemotherapy|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
11084276|NCT01491737|OG000|Outcome|Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
11084277|NCT01491737|OG001|Outcome|Arm B: Trastuzumab + AI +/- Chemotherapy|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
11084278|NCT01491737|EG000|Reported Event|Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
11084279|NCT01491737|EG001|Reported Event|Arm B: Trastuzumab + AI +/- Chemotherapy|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurred first. Participants also received an aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
11084280|NCT01491802|BG000|Baseline|Randomized Subjects|All 17 randomized subjects.
11084281|NCT01491802|FG000|Participant Flow|LAMA, Then LAMA/LABA|Participants first received LAMA alone (umeclidinium 125 mcg) once daily for 4 weeks. After a 2 week washout period, they received the LAMA/LABA combination product (umeclidinium 125 mcg plus vilanterol 25 mcg) once daily for 4 weeks.
11084282|NCT01491802|FG001|Participant Flow|LAMA/LABA, the LAMA|Participants first received the LAMA/LABA combination product (umeclidinium 125 mcg plus vilanterol 25 mcg) once daily for 4 weeks. After a 2 week washout period, they received LAMA alone (umeclidinium 125 mcg) once daily for 4 weeks.
11084283|NCT01491802|OG000|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
11084284|NCT01491802|OG001|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
11084285|NCT01491802|EG000|Reported Event|LAMA Arm|The 4-week treatment period with once daily inhaled umeclidinium (125 mcg).
11084286|NCT01491802|EG001|Reported Event|LABA/LAMA Arm|The 4-week treatment period with once daily inhaled fixed-dose combination of umeclidinium (125 mcg) and vilanterol (25 mcg).
11084287|NCT01491802|EG002|Reported Event|Washout Period|There was a 2 week washout period between the two treatment arms.
11084288|NCT01491841|BG000|Baseline|Bendamustine + Rituximab + Pixantrone|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084289|NCT01491841|FG000|Participant Flow|Bendamustine + Rituximab + Pixantrone|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD (maximum tolerated dose); to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084290|NCT01491841|OG000|Outcome|Bendamustine + Rituximab + Pixantrone + Pegfilgrastim|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084291|NCT01491841|OG000|Outcome|Pixantrone, 55mg/m^2|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 55mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084292|NCT01491841|OG001|Outcome|Pixantrone, 85mg/m^2|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084293|NCT01491841|OG002|Outcome|Pixantrone, 115mg/m^2|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084294|NCT01491841|OG000|Outcome|Phase 1: Pixantrone, 55mg/m^2|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 55mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084295|NCT01491841|OG001|Outcome|Phase 1: Pixantrone, 85mg/m^2|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084296|NCT01491841|OG002|Outcome|Phase 1: Pixantrone, 115mg/m^2|"Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle~Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle)."
11084297|NCT01491841|EG000|Reported Event|Pixantrone, 55mg/m^2|Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 55mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
11084298|NCT01491841|EG001|Reported Event|Pixantrone, 85mg/m^2|Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
11084299|NCT01491841|EG002|Reported Event|Pixantrone, 115mg/m^2|Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
11084300|NCT01491854|BG000|Baseline|Monitoring of Long-term Safety|Long-term safety follow-up after the end of treatment with Omnitrope (single arm)
11084301|NCT01491854|FG000|Participant Flow|Monitoring of Long-term Safety|Long-term safety follow-up after the end of treatment with Omnitrope (single arm)
11084302|NCT01491854|OG000|Outcome|Monitoring of Long-term Safety|Long-term safety follow-up after the end of treatment with Omnitrope (single arm)
11084303|NCT01491854|EG000|Reported Event|Total|Total
11084304|NCT01491919|BG000|Baseline|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
11084305|NCT01491919|BG001|Baseline|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
11084306|NCT01491919|BG002|Baseline|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
11084307|NCT01491919|BG003|Baseline|Total|Total of all reporting groups
11084308|NCT01491919|FG000|Participant Flow|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
11084309|NCT01491919|FG001|Participant Flow|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
11084310|NCT01491919|FG002|Participant Flow|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
11084311|NCT01491919|OG000|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
11227736|NCT02385799|EG000|Reported Event|Sertraline Liquid Placebo|"The placebo will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid placebo once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid placebo once per day for a period of six months.~Sertraline Liquid Placebo: Liquid placebo given in parallel to active medication"
11227737|NCT02385799|EG001|Reported Event|Sertraline Active Medication|"Liquid sertraline (20 mg/cc) will be dosed in an age depended manner. Participants aged 2-3 years of age at enrollment will be given 2.5 mg of liquid sertraline once per day for a period of six months. Participants aged 4-5 years at enrollment will be given 5 mg of liquid sertraline once per day for a period of six months.~Sertraline: Active medication"
11227738|NCT02386098|BG000|Baseline|Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
11227739|NCT02386098|BG001|Baseline|Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
11227740|NCT02386098|BG002|Baseline|Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227741|NCT02386098|BG003|Baseline|Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227742|NCT02386098|BG004|Baseline|Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227743|NCT02386098|BG005|Baseline|Total|Total of all reporting groups
11227744|NCT02386098|FG000|Participant Flow|Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
11227745|NCT02386098|FG001|Participant Flow|Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
11227746|NCT02386098|FG002|Participant Flow|Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227747|NCT02386098|FG003|Participant Flow|Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227748|NCT02386098|FG004|Participant Flow|Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227749|NCT02386098|OG000|Outcome|Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
11227750|NCT02386098|OG001|Outcome|Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
11227751|NCT02386098|OG000|Outcome|Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11084312|NCT01491919|OG001|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
11084313|NCT01491919|OG002|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
11084314|NCT01491919|OG000|Outcome|Lisinopril-naive|These protocol participants were not randomized. Instead, the older age group (7-17 years) were first enrolled consecutively into each dose level, starting with the lowest dose level (0.1 mg/kg per day). After enrollment is complete in the low dose level for an eGFR strata, enrollment will commence for the intermediate (0.2 mg/kg per day) dosage in that strata, followed by the high (0.4 mg/kg per day) dosage level. Enrollment for the 2-6 years age group did not begin until enrollment in the older age group (7-17 years) for the low and intermediate dosage level at each eGFR strata is complete.
11227752|NCT02386098|OG001|Outcome|Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227753|NCT02386098|OG002|Outcome|Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227754|NCT02386098|EG000|Reported Event|Stage 1: BMS955176+ATV/r+DTG|Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
11084315|NCT01491919|OG001|Outcome|Lisinopril Standard of Care (SOC)|These protocol participants were enrolled and continued on the lisinopril dose prescribed as standard of care. They were assigned to the appropriate eGFR and dose level stratum (rounding to the closest dose level). Since the lisinopril dose was assigned based on standard of care, a patient was enrolled without regard to open/closed status of the dose stratum in this group. Therefore, over enrollment of a specific dose and eGFR stratum was allowed for participants enrolled he the Lisinopril-naive group to accommodate these valuable low-risk participants already taking lisinopril.
11084316|NCT01491919|EG000|Reported Event|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
11084317|NCT01491919|EG001|Reported Event|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
11084318|NCT01491919|EG002|Reported Event|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
11084319|NCT01491945|BG000|Baseline|Ventana Fenestrated Stent Graft System|"Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:~bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts"
11084320|NCT01491945|FG000|Participant Flow|Ventana Fenestrated Stent Graft System|"Objective is to study the safety and effectiveness of the Endologix Fenestrated Stent Graft System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms. Subjects were treated with the Ventana Fenestrated system in this arm and The Ventana Fenestrated Stent Graft System consisted of the following:~bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts."
11084321|NCT01491945|OG000|Outcome|Ventana Fenestrated Stent Graft System|"Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:~bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts"
11084322|NCT01491945|OG000|Outcome|Ventana Fenestrated Stent Graft System|Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following: bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
11084323|NCT01491945|EG000|Reported Event|Ventana Fenestrated Stent Graft System|"Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:~bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts"
11084324|NCT01491958|BG000|Baseline|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
11227755|NCT02386098|EG001|Reported Event|Stage 1: TDF+ATV/r+DTG|Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
11227756|NCT02386098|EG002|Reported Event|Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227757|NCT02386098|EG003|Reported Event|Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11227758|NCT02386098|EG004|Reported Event|Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD|Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
11084325|NCT01491958|BG001|Baseline|Donor|Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration.
11084326|NCT01491958|BG002|Baseline|Total|Total of all reporting groups
11084327|NCT01491958|FG000|Participant Flow|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
11084328|NCT01491958|FG001|Participant Flow|Donors|Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration.
11084329|NCT01491958|OG000|Outcome|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
11092073|NCT01537198|OG000|Outcome|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.
11084330|NCT01491958|OG000|Outcome|Patients|"Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.~atorvastatin: donors-will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Patients-will receive"
11084331|NCT01491958|EG000|Reported Event|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
11084332|NCT01491984|BG000|Baseline|Intubation Order Levitan/MAC|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
11084333|NCT01491984|BG001|Baseline|Intubation Order MAC/Levitan|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice).
11084334|NCT01491984|BG002|Baseline|Total|Total of all reporting groups
11084335|NCT01491984|FG000|Participant Flow|Levitan FPS/Mac Laryngoscope Intubation Order|"Intubation with Levitan~laryngoscopy view with Levitan :"
11084336|NCT01491984|FG001|Participant Flow|Macintosh/Levitan FPS Laryngoscope Intubation Order|"traditional MAC intubation~laryngoscopy view with MAC :"
11084337|NCT01491984|OG000|Outcome|Levitan/MAC Intubation|Laryngoscopy with Levitan, then MAC
11084338|NCT01491984|OG001|Outcome|MAC/Levitan Intubation|Laryngoscopy with MAC then Levitan
11084339|NCT01491984|EG000|Reported Event|Levitan FPS Intubation|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
11084340|NCT01491984|EG001|Reported Event|Macintosh Intubation|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice)
11084341|NCT01492088|BG000|Baseline|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
11084342|NCT01492088|BG001|Baseline|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084343|NCT01492088|BG002|Baseline|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084344|NCT01492088|BG003|Baseline|Total|Total of all reporting groups
11084345|NCT01492088|FG000|Participant Flow|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
11084346|NCT01492088|FG001|Participant Flow|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084347|NCT01492088|FG002|Participant Flow|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084348|NCT01492088|OG000|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
11084349|NCT01492088|OG001|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084350|NCT01492088|OG001|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084351|NCT01492088|OG001|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r Hodgkin Lymphoma (HL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11233778|NCT02431260|BG009|Baseline|Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11084352|NCT01492088|OG002|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084353|NCT01492088|OG001|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084354|NCT01492088|EG000|Reported Event|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
11084355|NCT01492088|EG001|Reported Event|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084356|NCT01492088|EG002|Reported Event|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
11084357|NCT01492101|BG000|Baseline|NKTR-102|NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
11084358|NCT01492101|BG001|Baseline|Physician's Treatment of Choice|"Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:~eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel"
11084359|NCT01492101|BG002|Baseline|Total|Total of all reporting groups
11084360|NCT01492101|FG000|Participant Flow|NKTR-102|NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
11084361|NCT01492101|FG001|Participant Flow|Physician's Treatment of Choice|"Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:~eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel"
11084362|NCT01492101|OG000|Outcome|NKTR-102|NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
11084363|NCT01492101|OG001|Outcome|Physician's Treatment of Choice|"Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:~eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel"
11084364|NCT01492101|EG000|Reported Event|NKTR-102|NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
11084365|NCT01492101|EG001|Reported Event|Physician's Treatment of Choice|"Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:~eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel"
11084366|NCT01492309|BG000|Baseline|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11084367|NCT01492309|BG001|Baseline|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11084368|NCT01492309|BG002|Baseline|Total|Total of all reporting groups
11084369|NCT01492309|FG000|Participant Flow|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11084370|NCT01492309|FG001|Participant Flow|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11084371|NCT01492309|OG000|Outcome|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11084372|NCT01492309|OG001|Outcome|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11084373|NCT01492309|EG000|Reported Event|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11084374|NCT01492309|EG001|Reported Event|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11084375|NCT01492400|BG000|Baseline|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
11084376|NCT01492400|BG001|Baseline|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
11084377|NCT01492400|BG002|Baseline|Total|Total of all reporting groups
11084378|NCT01492400|FG000|Participant Flow|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
11084379|NCT01492400|FG001|Participant Flow|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
11084380|NCT01492400|OG000|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
11084381|NCT01492400|OG001|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
11084382|NCT01492400|EG000|Reported Event|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
11084383|NCT01492400|EG001|Reported Event|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
11084384|NCT01492426|BG000|Baseline|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
11084385|NCT01492426|BG001|Baseline|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
11084386|NCT01492426|BG002|Baseline|Total|Total of all reporting groups
11084387|NCT01492426|FG000|Participant Flow|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
11084388|NCT01492426|FG001|Participant Flow|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
11084389|NCT01492426|OG000|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
11084390|NCT01492426|OG001|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
11084391|NCT01492426|OG000|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000 - 1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
11084392|NCT01492426|OG001|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200mg per day was administered twice daily with food.
11084393|NCT01492426|OG000|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
11084394|NCT01492426|OG000|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
11084395|NCT01492426|EG000|Reported Event|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day)
11084396|NCT01492426|EG001|Reported Event|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food
11084397|NCT01492439|BG000|Baseline|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
11084398|NCT01492439|BG001|Baseline|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
11084399|NCT01492439|BG002|Baseline|Total|Total of all reporting groups
11233779|NCT02431260|BG010|Baseline|Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11084400|NCT01492439|FG000|Participant Flow|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a week for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
11084401|NCT01492439|FG001|Participant Flow|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
11084402|NCT01492439|OG000|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
11084403|NCT01492439|OG001|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
11084404|NCT01492439|EG000|Reported Event|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
11084405|NCT01492439|EG001|Reported Event|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
11084406|NCT01492582|BG000|Baseline|Prevention (Vaccine Therapy)|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084407|NCT01492582|BG001|Baseline|Survey|Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.
11084408|NCT01492582|BG002|Baseline|Total|Total of all reporting groups
11084409|NCT01492582|FG000|Participant Flow|Prevention (Vaccine Therapy)|"Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.~laboratory biomarker analysis: Correlative studies~survey administration: Ancillary studies~medical chart review: Ancillary studies"
11084410|NCT01492582|FG001|Participant Flow|Survey Arm|Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.
11084411|NCT01492582|OG000|Outcome|Survey Participants|Participants who consented to the survey aim of the study.
11084412|NCT01492582|OG000|Outcome|Quadrivalent Anti-HPV 16, Male, Age 9-15 Years|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084413|NCT01492582|OG001|Outcome|Quadrivalent Anti-HPV 16, Female, Age 9-15 Years|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084414|NCT01492582|OG002|Outcome|Quadrivalent Anti-HPV 16, Male, Age 16-26 Years|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084415|NCT01492582|OG003|Outcome|Quadrivalent Anti-HPV 16, Female, Age 16-26 Years|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084416|NCT01492582|OG004|Outcome|Nonavalent Anti-HPV 16, Male, Age 9-15 Years|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11227759|NCT02386189|BG000|Baseline|Usual Care|Veterans randomized to usual care will not receive any training on using their patient portal(s) to access and share information. They will be contacted via phone and/or secure messaging to remind him/her to take the VA or non-VA provider packet to their appointment. At the conclusion of the study, Veterans assigned to usual care will be provided the training information on the VA health summary for their own reference.
11233780|NCT02431260|BG011|Baseline|Part 1 / Treatment Group B: 20 MG BID INCB054329|Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
11084417|NCT01492582|OG005|Outcome|Nonavalent Anti-HPV 16, Female, Age 9-15 Years|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084418|NCT01492582|OG006|Outcome|Nonavalent Anti-HPV 16, Male, Age 16-26 Years|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084419|NCT01492582|OG007|Outcome|Nonavalent Anti-HPV 16, Female, Age 16-26 Years|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084420|NCT01492582|OG008|Outcome|Quadrivalent Anti-HPV 18, Male, Age 9-15 Years|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084421|NCT01492582|OG009|Outcome|Quadrivalent Anti-HPV 18, Female, Age 9-15 Years|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084422|NCT01492582|OG010|Outcome|Quadrivalent Anti-HPV 18, Male, Age 16-26 Years|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084423|NCT01492582|OG011|Outcome|Quadrivalent Anti-HPV 18, Female, Age 16-26 Years|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084424|NCT01492582|OG012|Outcome|Nonavalent Anti-HPV 18, Male, Age 9-15 Years|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084425|NCT01492582|OG013|Outcome|Nonavalent Anti-HPV 18, Female, Age 9-15 Years|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084426|NCT01492582|OG014|Outcome|Nonavalent Anti-HPV 18, Male, Age 16-26 Years|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084427|NCT01492582|OG015|Outcome|Nonavalent Anti-HPV 18, Female, Age 16-26 Years|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084428|NCT01492582|OG000|Outcome|Prevention (Vaccine Therapy)- Quadrivalent|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084429|NCT01492582|OG001|Outcome|Nonavalent Vaccine|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084430|NCT01492582|EG000|Reported Event|Prevention (Vaccine Therapy)- Quadrivalent|Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084431|NCT01492582|EG001|Reported Event|Prevention (Vaccine Therapy)- Nonavalent Vaccine|Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
11084432|NCT01492673|BG000|Baseline|Cyclophosphamide, Topotecan, and Bevacizumab (CTB)|"This is a multi-center, open label phase II study evaluating the safety and efficacy of the novel combination of agents consisting of bevacizumab, cyclophosphamide, and topotecan.~Cyclophosphamide, Topotecan, and Bevacizumab: The treatment schedule for this study will consist of a 21-day cycle. Dose modification will only occur with administration of the investigational agent, bevacizumab. The schedule of administration is summarized as follows. Administration of bevacizumab will precede the administration of the cyclophosphamide and topotecan by 3 days (Day - 3) to allow for vascular stabilization prior to initiation of chemotherapy. The chemotherapy backbone will consist of cyclophosphamide and topotecan administered as follows: cyclophosphamide 250 mg/m2/day IV over 30 minutes ± 5 minutes on Days 0-4 followed by topotecan 0.75 mg/m2/day IV over 30 minutes ± 5 minutes on Day 0-4 of every cycle. The dosing of cyclophosphamide and topotecan will be fixed."
11084433|NCT01492673|FG000|Participant Flow|Cyclophosphamide, Topotecan, and Bevacizumab (CTB)|"This is a multi-center, open label phase II study evaluating the safety and efficacy of the novel combination of agents consisting of bevacizumab, cyclophosphamide, and topotecan.~Cyclophosphamide, Topotecan, and Bevacizumab: The treatment schedule for this study will consist of a 21-day cycle. Dose modification will only occur with administration of the investigational agent, bevacizumab. The schedule of administration is summarized as follows. Administration of bevacizumab will precede the administration of the cyclophosphamide and topotecan by 3 days (Day - 3) to allow for vascular stabilization prior to initiation of chemotherapy. The chemotherapy backbone will consist of cyclophosphamide and topotecan administered as follows: cyclophosphamide 250 mg/m2/day IV over 30 minutes ± 5 minutes on Days 0-4 followed by topotecan 0.75 mg/m2/day IV over 30 minutes ± 5 minutes on Day 0-4 of every cycle. The dosing of cyclophosphamide and topotecan will be fixed."
11084434|NCT01492673|OG000|Outcome|Cyclophosphamide, Topotecan, and Bevacizumab (CTB)|"This is a multi-center, open label phase II study evaluating the safety and efficacy of the novel combination of agents consisting of bevacizumab, cyclophosphamide, and topotecan.~Cyclophosphamide, Topotecan, and Bevacizumab: The treatment schedule for this study will consist of a 21-day cycle. Dose modification will only occur with administration of the investigational agent, bevacizumab. The schedule of administration is summarized as follows. Administration of bevacizumab will precede the administration of the cyclophosphamide and topotecan by 3 days (Day - 3) to allow for vascular stabilization prior to initiation of chemotherapy. The chemotherapy backbone will consist of cyclophosphamide and topotecan administered as follows: cyclophosphamide 250 mg/m2/day IV over 30 minutes ± 5 minutes on Days 0-4 followed by topotecan 0.75 mg/m2/day IV over 30 minutes ± 5 minutes on Day 0-4 of every cycle. The dosing of cyclophosphamide and topotecan will be fixed."
11092074|NCT01537198|EG000|Reported Event|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.
11092075|NCT01537211|BG000|Baseline|Microprocessor Knee Then Mechanical Knee|C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees
11084435|NCT01492673|EG000|Reported Event|Cyclophosphamide, Topotecan, and Bevacizumab (CTB)|"This is a multi-center, open label phase II study evaluating the safety and efficacy of the novel combination of agents consisting of bevacizumab, cyclophosphamide, and topotecan.~Cyclophosphamide, Topotecan, and Bevacizumab: The treatment schedule for this study will consist of a 21-day cycle. Dose modification will only occur with administration of the investigational agent, bevacizumab. The schedule of administration is summarized as follows. Administration of bevacizumab will precede the administration of the cyclophosphamide and topotecan by 3 days (Day - 3) to allow for vascular stabilization prior to initiation of chemotherapy. The chemotherapy backbone will consist of cyclophosphamide and topotecan administered as follows: cyclophosphamide 250 mg/m2/day IV over 30 minutes ± 5 minutes on Days 0-4 followed by topotecan 0.75 mg/m2/day IV over 30 minutes ± 5 minutes on Day 0-4 of every cycle. The dosing of cyclophosphamide and topotecan will be fixed."
11084436|NCT01492686|BG000|Baseline|MCI-186|Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
11084437|NCT01492686|BG001|Baseline|Placebo of MCI-186|Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
11084438|NCT01492686|BG002|Baseline|Total|Total of all reporting groups
11084439|NCT01492686|FG000|Participant Flow|MCI-186|Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
11084440|NCT01492686|FG001|Participant Flow|Placebo of MCI-186|Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
11084441|NCT01492686|OG000|Outcome|MCI-186|Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
11084442|NCT01492686|OG001|Outcome|Placebo of MCI-186|Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
11084443|NCT01492686|EG000|Reported Event|Double-blind MCI-186|MCI-186 in Double-blind. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
11084444|NCT01492686|EG001|Reported Event|Double-blind Placebo of MCI-186|Placebo of MCI-186 in Double-blind. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
11227760|NCT02386189|BG001|Baseline|Care Coordination|"Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated.~Patient Care Coordination Training: Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated."
11227761|NCT02386189|BG002|Baseline|Total|Total of all reporting groups
11233781|NCT02431260|BG012|Baseline|Part 2 / Treatment Group A: 20 MG BID INCB054329|Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
11084445|NCT01492686|EG002|Reported Event|Open-label MCI-186 (Double-blind MCI-186, Then Open-label)|MCI-186 in Open-label (Double-blind MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
11084446|NCT01492686|EG003|Reported Event|Open-label MCI-186 (Double-blind Placebo, Then Open-label)|MCI-186 in Open-label (Double-blind Placebo of MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
11084447|NCT01493024|BG000|Baseline|Placebo|Placebo randomized to mimic escalating doses of experimental drug administered three times daily .
11084448|NCT01493024|BG001|Baseline|Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily|Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water
11084449|NCT01493024|BG002|Baseline|Sodium Zirconium Cyclosilicate 3 g Three Times Daily|Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water
11084450|NCT01493024|BG003|Baseline|Sodium Zirconium Cyclosilicate 10 g Three Times Daily|Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water
11084451|NCT01493024|BG004|Baseline|Total|Total of all reporting groups
11084452|NCT01493024|FG000|Participant Flow|Placebo|Placebo randomized to mimic escalating doses of experimental drug administered three times daily .
11084453|NCT01493024|FG001|Participant Flow|Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily|Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water
11084454|NCT01493024|FG002|Participant Flow|Sodium Zirconium Cyclosilicate 3 g Three Times Daily|Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water
11084455|NCT01493024|FG003|Participant Flow|Sodium Zirconium Cyclosilicate 10 g Three Times Daily|Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water
11084456|NCT01493024|OG000|Outcome|Placebo (Combined All Three Cohorts)|Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID).
11084457|NCT01493024|OG001|Outcome|Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily|Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water
11084458|NCT01493024|OG002|Outcome|Sodium Zirconium Cyclosilicate 3 g Three Times Daily|Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water
11084459|NCT01493024|OG003|Outcome|Sodium Zirconium Cyclosilicate 10 g Three Times Daily|Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water
11084460|NCT01493024|OG002|Outcome|Zirconium Silicate 3 g Three Times Daily|Zirconium Silicate (ZS) 3 g TID, three times daily as a suspension in water
11084461|NCT01493024|EG000|Reported Event|Placebo|Placebo randomized to mimic escalating doses of experimental drug administered three times daily .
11084462|NCT01493024|EG001|Reported Event|Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily|Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water
11084463|NCT01493024|EG002|Reported Event|Sodium Zirconium Cyclosilicate 3 g Three Times Daily|Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water
11084464|NCT01493024|EG003|Reported Event|Sodium Zirconium Cyclosilicate 10 g Three Times Daily|Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water
11084465|NCT01493089|BG000|Baseline|Zegerid|Treatment of heartburn with Zegerid
11084466|NCT01493089|BG001|Baseline|Losec|Treatment of heartburn with Losec
11084467|NCT01493089|BG002|Baseline|Total|Total of all reporting groups
11084468|NCT01493089|FG000|Participant Flow|Zegerid|Treatment of heartburn with 20mg Zegerid suspension plus over-encapsulated placebo capsule once a day
11084469|NCT01493089|FG001|Participant Flow|Losec|Treatment of heartburn with 20mg Losec over-capsulated capsule plus placebo suspension once a day
11084470|NCT01493089|OG000|Outcome|Zegerid Group|20mg Zegerid suspension plus over-encapsulated placebo capsule
11084471|NCT01493089|OG001|Outcome|Losec Group|20mg Losec over-encapsulated capsule plus placebo suspension
11084472|NCT01493089|OG000|Outcome|Zegerid Group|
11084473|NCT01493089|OG001|Outcome|Losec Group|
11084474|NCT01493089|EG000|Reported Event|Zegerid|Treatment of heartburn with Zegerid
11084475|NCT01493089|EG001|Reported Event|Losec|Treatment of heartburn with Losec
11084476|NCT01493167|BG000|Baseline|Woodcast Circular System Casts|Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast
11084477|NCT01493167|FG000|Participant Flow|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
11084478|NCT01493167|OG000|Outcome|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
11084479|NCT01493167|EG000|Reported Event|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
11084480|NCT01493180|BG000|Baseline|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
11084481|NCT01493180|BG001|Baseline|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
11084482|NCT01493180|BG002|Baseline|Total|Total of all reporting groups
11084483|NCT01493180|FG000|Participant Flow|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
11084484|NCT01493180|FG001|Participant Flow|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
11084485|NCT01493180|OG000|Outcome|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
11084486|NCT01493180|OG001|Outcome|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
11084487|NCT01493180|EG000|Reported Event|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
11084488|NCT01493180|EG001|Reported Event|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
11084489|NCT01493284|BG000|Baseline|Transfemoral|Transfemoral access
11084490|NCT01493284|FG000|Participant Flow|Transfemoral|Transfemoral access
11084491|NCT01493284|OG000|Outcome|Transfemoral|Transfemoral access
11084492|NCT01493284|EG000|Reported Event|Transfemoral|Transfemoral access
11084493|NCT01493414|BG000|Baseline|INC424|"5 - 25 mg twice a day (BID)~INC424: All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally."
11084494|NCT01493414|FG000|Participant Flow|INC424|"5 - 25 mg twice a day (BID)~INC424: All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally."
11084495|NCT01493414|OG000|Outcome|INC424|"5 - 25 mg twice a day (BID)~INC424: All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally."
11084496|NCT01493414|OG000|Outcome|INC424 - Responders|"Responders with spleen length between 5 and 10 cm=non palpable spleen. Responders with spleen length more than 10 cm=Spleen reduction of 50% from baseline.~5 - 25 mg twice a day (BID) INC424: All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally."
11084497|NCT01493414|OG001|Outcome|INC424 - Stable Disease|"Participants with Stable Disease with spleen length between 5 and 10 cm=does not meet criteria for response or disease progression.~Participants with Stable Disease with spleen length more than 10 cm=does not meet criteria for response or disease progression.~5 - 25 mg twice a day (BID) INC424: All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally."
11084498|NCT01493414|OG002|Outcome|INC424 - Progressive Disease|"Participants with Progressive Disease with spleen length between 5 and 10 cm=increase of 100% from baseline in spleen length.~Participants with Progressive Disease with spleen length more than 10 cm=increase of 50% from baseline in spleen length.~5 - 25 mg twice a day (BID) INC424: All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally."
11084499|NCT01493414|OG003|Outcome|INC424 - Missing|"Missing values.~5 - 25 mg twice a day (BID) INC424: All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally."
11084500|NCT01493414|EG000|Reported Event|INC424|All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 25 mg twice a day. No INC424 dose will exceed 20 mg BID orally.
11084501|NCT01493427|BG000|Baseline|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
11084502|NCT01493427|FG000|Participant Flow|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
11084503|NCT01493427|OG000|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
11084504|NCT01493427|EG000|Reported Event|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
11084505|NCT01493531|BG000|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
11084506|NCT01493531|BG001|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
11084507|NCT01493531|BG002|Baseline|Placebo + Allopurinol|
11084508|NCT01493531|BG003|Baseline|Total|Total of all reporting groups
11084509|NCT01493531|FG000|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
11227762|NCT02386189|FG000|Participant Flow|Usual Care|Veterans randomized to usual care will not receive any training on using their patient portal(s) to access and share information. They will be contacted via phone and/or secure messaging to remind him/her to take the VA or non-VA provider packet to their appointment. At the conclusion of the study, Veterans assigned to usual care will be provided the training information on the VA health summary for their own reference.
11084510|NCT01493531|FG001|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
11084511|NCT01493531|FG002|Participant Flow|Placebo + Allopurinol|
11084512|NCT01493531|OG000|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
11084513|NCT01493531|OG001|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
11084514|NCT01493531|OG002|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
11084515|NCT01493531|EG000|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
11084516|NCT01493531|EG001|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
11084517|NCT01493531|EG002|Reported Event|Placebo + Allopurinol|
11084518|NCT01493557|BG000|Baseline|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
11084519|NCT01493557|BG001|Baseline|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
11084520|NCT01493557|BG002|Baseline|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
11084521|NCT01493557|BG003|Baseline|Total|Total of all reporting groups
11084522|NCT01493557|FG000|Participant Flow|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
11084523|NCT01493557|FG001|Participant Flow|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
11084524|NCT01493557|FG002|Participant Flow|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
11084525|NCT01493557|OG000|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
11084526|NCT01493557|OG001|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
11084527|NCT01493557|EG000|Reported Event|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
11084528|NCT01493557|EG001|Reported Event|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
11084529|NCT01493557|EG002|Reported Event|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
11084530|NCT01493596|BG000|Baseline|CPP-115 Dose 1|"Cohort 1 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084531|NCT01493596|BG001|Baseline|CPP-115 Dose 2|"Cohort 2a consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11092076|NCT01537211|BG001|Baseline|Mechanical Knee Then Microprocessor Knee|C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees
11092077|NCT01537211|BG002|Baseline|Total|Total of all reporting groups
11084532|NCT01493596|BG002|Baseline|CPP-115 Dose 2 (Repeat)|"Cohort 2(b) consisted of 7 subjects with 5 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084533|NCT01493596|BG003|Baseline|CPP-115 Dose 3|"Cohort 3 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084534|NCT01493596|BG004|Baseline|CPP-115 Dose 4|"Cohort 4 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084535|NCT01493596|BG005|Baseline|CPP-115 Dose 5|"Cohort 5 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084536|NCT01493596|BG006|Baseline|CPP-115 Dose 6|"Cohort 1 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084537|NCT01493596|BG007|Baseline|Total|Total of all reporting groups
11084538|NCT01493596|FG000|Participant Flow|CPP-115 Dose 1|"Cohort 1 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084539|NCT01493596|FG001|Participant Flow|CPP-115 Dose 2|"Cohort 2a consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084540|NCT01493596|FG002|Participant Flow|CPP-115 Dose 2 (Repeat)|"Cohort 2(b) consisted of 7 subjects with 5 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11233782|NCT02431260|BG013|Baseline|Part 2 / Treatment Group C: 20 mg BID INCB054329|Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
11084541|NCT01493596|FG003|Participant Flow|CPP-115 Dose 3|"Cohort 3 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084542|NCT01493596|FG004|Participant Flow|CPP-115 Dose 4|"Cohort 4 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084543|NCT01493596|FG005|Participant Flow|CPP-115 Dose 5|"Cohort 5 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084544|NCT01493596|FG006|Participant Flow|CPP-115 Dose 6|"Cohort 1 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Assessment of safety based on committee review the safety data obtained from this dose.~Placebo : 5 ml water mixed with ~250 ml juice was administered.~CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing."
11084545|NCT01493596|OG000|Outcome|CPP-115 Dose 1 (5mg)|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084546|NCT01493596|OG001|Outcome|CPP-115 Dose 2 (13mg)|"2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084547|NCT01493596|OG002|Outcome|CPP-115 Dose 3 (32mg)|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~There were no deaths or SAEs~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered."
11084548|NCT01493596|OG003|Outcome|CPP-115 Dose 4 (80mg)|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084549|NCT01493596|OG004|Outcome|CPP-115 Dose 5 (200mg)|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084550|NCT01493596|OG005|Outcome|CPP-115 Dose 6 (500mg)|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084551|NCT01493596|EG000|Reported Event|CPP-115 Dose 1|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084552|NCT01493596|EG001|Reported Event|CPP-115 Dose 2|"2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084553|NCT01493596|EG002|Reported Event|CPP-115 Dose 3|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~There were no deaths or SAEs~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered."
11084554|NCT01493596|EG003|Reported Event|CPP-115 Dose 4|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084555|NCT01493596|EG004|Reported Event|CPP-115 Dose 5|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084556|NCT01493596|EG005|Reported Event|CPP-115 Dose 6|"Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.~CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.~Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs"
11084557|NCT01493687|BG000|Baseline|CD5024 1% Cream|Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks
11084558|NCT01493687|BG001|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks~Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
11084559|NCT01493687|BG002|Baseline|Total|Total of all reporting groups
11233783|NCT02431260|BG014|Baseline|Total|Total of all reporting groups
11233784|NCT02431260|FG000|Participant Flow|Part 1 / Treatment Group A: 15 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11084560|NCT01493687|FG000|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
11084561|NCT01493687|FG001|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application~Part B: Azelaic acid 15% Gel, twice daily application"
11084562|NCT01493687|OG000|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
11084563|NCT01493687|OG001|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
11233785|NCT02431260|FG001|Participant Flow|Part 1 / Treatment Group A: 22.5 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11084564|NCT01493687|EG000|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
11084565|NCT01493687|EG001|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
11084566|NCT01493687|EG002|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
11084567|NCT01493687|EG003|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
11084568|NCT01493687|EG004|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
11084569|NCT01493687|EG005|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
11227763|NCT02386189|FG001|Participant Flow|Care Coordination|"Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated.~Patient Care Coordination Training: Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated."
11227764|NCT02386189|OG000|Outcome|Usual Care|Veterans randomized to usual care will not receive any training on using their patient portal(s) to access and share information. They will be contacted via phone and/or secure messaging to remind him/her to take the VA or non-VA provider packet to their appointment. At the conclusion of the study, Veterans assigned to usual care will be provided the training information on the VA health summary for their own reference.
11233786|NCT02431260|FG002|Participant Flow|Part 1 / Treatment Group A: 15 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11233787|NCT02431260|FG003|Participant Flow|Part 1 / Treatment Group A: 30 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11084570|NCT01493687|EG006|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
11084571|NCT01493687|EG007|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
11084572|NCT01493778|BG000|Baseline|Turoctocog Alfa (N8) (Preventive+On-demand)|Participants received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the participant's clinical profile. Participants who enrolled into the trial initiated the preventive treatment no later than their second birthday or after a maximum of 2 bleeding episodes requiring treatment, whichever came first. The trial consisted of two phases. In the main phase, an aggregated number of at least 50 participants received preventive treatment with turoctocog alfa until they reached a minimum of 50 exposure days (ED) or until they developed inhibitors. After that the participants continued in the extension phase where at least 50 participants achieved at least 100 ED, which translated into a maximum trial duration of up to 5 years (including any potential inhibitor treatment). The estimated total duration of the trial was approximately 7 years.
11084573|NCT01493778|FG000|Participant Flow|Turoctocog Alfa (N8) (Preventive+On-demand Treatment)|Participants received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the participant's clinical profile. Participants who enrolled into the trial initiated the preventive treatment no later than their second birthday or after a maximum of 2 bleeding episodes requiring treatment, whichever came first. The trial consisted of two phases. In the main phase, an aggregated number of at least 50 participants received preventive treatment with turoctocog alfa until they reached a minimum of 50 exposure days (ED) or until they developed inhibitors. After that the participants continued in the extension phase where at least 50 participants achieved at least 100 ED, which translated into a maximum trial duration of up to 5 years (including any potential inhibitor treatment). The estimated total duration of the trial was approximately 7 years.
11084574|NCT01493778|OG000|Outcome|Turoctocog Alfa (N8): Main Phase (Preventive Treatment)|Participants received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the participant's clinical profile. Subjects received prophylactic factor VIII replacement therapy (preventive treatment) until Visit 5 or until development of inhibitor, whichever came first. In the main phase, an aggregated number of at least 50 participants received preventive treatment with turoctocog alfa until they reached a minimum of 50 exposure days (ED) or until they developed inhibitors.
11084575|NCT01493778|OG000|Outcome|Turoctocog Alfa (N8): Main Phase (On-demand Treatment)|Participants (children≤2 years) received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection as on-demand treatment while waiting to start on a preventive regimen. The investigator decided what dose of turoctocog alfa to give based on the participant's clinical profile. This treatment period included Visit 2 to first preventive dose.
11084576|NCT01493778|OG001|Outcome|Turoctocog Alfa (N8): Main Phase (Preventive Treatment)|Participants received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the participant's clinical profile. Subjects received prophylactic factor VIII replacement therapy (preventive treatment) until Visit 5 or until development of inhibitor, whichever came first. In the main phase, an aggregated number of at least 50 participants received preventive treatment with turoctocog alfa until they reached a minimum of 50 exposure days (ED) or until they developed inhibitors.
11092078|NCT01537211|FG000|Participant Flow|Microprocessor Knee Then Mechanical Knee|C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees
11084577|NCT01493778|OG002|Outcome|Turoctocog Alfa (N8): Extension Phase (Preventive Treatment)|Participants received prophylactic treatment administered from completion of the main phase or completion of the inhibitor cohort until the end-of-trial visit in the extension phase. They received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the participant's clinical profile. After completing the main phase, participants continued in the extension phase where at least 50 participants achieved at least 100 ED, which translated into a maximum trial duration of up to 5 years (including any potential inhibitor treatment).
11084578|NCT01493778|OG003|Outcome|Turoctocog Alfa (N8): Combined-Main+Ext, Preventive Treatment|Participants who started preventive treatment in the main and extension phase are included in this arm. They received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the child's clinical profile. The trial consisted of two phases. In the main phase, an aggregated number of at least 50 participants received preventive treatment with turoctocog alfa until they reached a minimum of 50 exposure days (ED) or until they developed inhibitors. After that the participants continued in the extension phase where at least 50 participants achieved at least 100 ED, which translated into a maximum trial duration of up to 5 years (including any potential inhibitor treatment). The estimated total duration of the trial was approximately 7 years.
11084579|NCT01493778|OG004|Outcome|Turoctocog Alfa (N8): Inhibitor Cohort|Participants who developed an inhibitor during the course of the trial and followed an alternative treatment regimen are included in this arm. They were offered continued treatment with turoctocog alfa for up to 24 months.
11084580|NCT01493778|OG001|Outcome|Turoctocog Alfa (N8): Extension Phase (Preventive Treatment)|Participants received prophylactic treatment administered from completion of the main phase or completion of the inhibitor cohort until the end-of-trial visit in the extension phase. They received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the participant's clinical profile. After completing the main phase, participants continued in the extension phase where at least 50 participants achieved at least 100 ED, which translated into a maximum trial duration of up to 5 years (including any potential inhibitor treatment).
11084581|NCT01493778|OG002|Outcome|Turoctocog Alfa (N8): Combined-Main+Ext, Preventive Treatment|Participants who started preventive treatment in the main and extension phase are included in this arm. They received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the child's clinical profile. The trial consisted of two phases. In the main phase, an aggregated number of at least 50 participants received preventive treatment with turoctocog alfa until they reached a minimum of 50 exposure days (ED) or until they developed inhibitors. After that the participants continued in the extension phase where at least 50 participants achieved at least 100 ED, which translated into a maximum trial duration of up to 5 years (including any potential inhibitor treatment). The estimated total duration of the trial was approximately 7 years.
11084582|NCT01493778|OG003|Outcome|Turoctocog Alfa (N8): Inhibitor Cohort|Participants who developed an inhibitor during the course of the trial and followed an alternative treatment regimen are included in this arm. They were offered continued treatment with turoctocog alfa for up to 24 months.
11084583|NCT01493778|OG000|Outcome|Turoctocog Alfa (N8): Combined-Main+Ext, Preventive Treatment|Participants who started preventive treatment in the main and extension phase are included in this arm. They received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the child's clinical profile. The trial consisted of two phases. In the main phase, an aggregated number of at least 50 participants received preventive treatment with turoctocog alfa until they reached a minimum of 50 exposure days (ED) or until they developed inhibitors. After that the participants continued in the extension phase where at least 50 participants achieved at least 100 ED, which translated into a maximum trial duration of up to 5 years (including any potential inhibitor treatment). The estimated total duration of the trial was approximately 7 years.
11084584|NCT01493778|EG000|Reported Event|Turoctocog Alfa|Participants received turoctocog alfa doses of 15-60 IU/kg body weight (BW) administered as an intravenous injection for the prevention of bleeding. The investigator decided what dose of turoctocog alfa to give based on the participant's clinical profile. Participants who enrolled into the trial initiated the preventive treatment no later than their second birthday or after a maximum of 2 bleeding episodes requiring treatment, whichever came first. The trial consists of two phases. In the main phase, an aggregated number of at least 50 participants received preventive treatment with turoctocog alfa until they reach a minimum of 50 exposure days (ED) or until they developed inhibitors. After that the participants continued in the extension phase where at least 50 participants achieved at least 100 ED, which will translate into a maximum trial duration of up to 5 years (including any potential inhibitor treatment). The estimated total duration of the trial was approximately 7 years.
11084585|NCT01493947|BG000|Baseline|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
11084586|NCT01493947|BG001|Baseline|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
11084587|NCT01493947|BG002|Baseline|Total|Total of all reporting groups
11084588|NCT01493947|FG000|Participant Flow|Ivermectin|Ivermectin applied once daily on the face during 16-week
11084589|NCT01493947|FG001|Participant Flow|Metronidazole 0.75% Cream|Metronidazole 0.75% cream applied twice daily on the face during 16-week
11084590|NCT01493947|OG000|Outcome|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
11084591|NCT01493947|OG001|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
11084592|NCT01493947|OG000|Outcome|CD5024|CD5024: CD5024 applied once daily on the face during 16-week plus 36-week extension period.
11084593|NCT01493947|EG000|Reported Event|Ivermectin 1% Cream Period A|Ivermectin applied once daily on the face during 16-week
11084594|NCT01493947|EG001|Reported Event|Metronidazole 0.75% Cream Period A|Metronidazole 0.75% cream applied twice daily on the face during 16-week
11084595|NCT01493947|EG002|Reported Event|Ivermectin 1% Cream Period B|36-week extension period :only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible
11084596|NCT01493947|EG003|Reported Event|Metronidazole 0.75% Cream Period B|36-week extension period : only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible.
11084597|NCT01493960|BG000|Baseline|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
11084598|NCT01493960|BG001|Baseline|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
11084599|NCT01493960|BG002|Baseline|Total|Total of all reporting groups
11084600|NCT01493960|FG000|Participant Flow|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
11084601|NCT01493960|FG001|Participant Flow|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
11084602|NCT01493960|OG000|Outcome|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
11084603|NCT01493960|OG001|Outcome|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
11084604|NCT01493960|EG000|Reported Event|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
11084605|NCT01493960|EG001|Reported Event|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
11084606|NCT01494038|BG000|Baseline|Arm A (Immediate INH Treatment)|"Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum"
11084607|NCT01494038|BG001|Baseline|Arm B (Deferred INH Treatment)|"Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum (Arm B)~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit (Arm B)"
11084608|NCT01494038|BG002|Baseline|Total|Total of all reporting groups
11084609|NCT01494038|FG000|Participant Flow|Arm A (Immediate INH Treatment)|"Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum"
11084610|NCT01494038|FG001|Participant Flow|Arm B (Deferred INH Treatment)|"Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit"
11084611|NCT01494038|OG000|Outcome|Arm A (Immediate INH Treatment)|"Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum"
11084612|NCT01494038|OG001|Outcome|Arm B (Deferred INH Treatment)|"Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum.~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit."
11084613|NCT01494038|OG001|Outcome|Arm B (Deferred INH Treatment)|"Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit"
11084614|NCT01494038|OG000|Outcome|Fast Metabolizers|Those women having a genotype of fast INH metabolism.
11084615|NCT01494038|OG001|Outcome|Intermediate Metabolizers|Those women having a genotype of intermediate INH metabolism.
11084616|NCT01494038|OG002|Outcome|Slow Metabolizers|Those women having a genotype of slow INH metabolism.
11084617|NCT01494038|OG000|Outcome|Fast Metabolizers|Those women with a phenotype of fast EFV metabolism.
11084618|NCT01494038|OG001|Outcome|Intermediate Metabolizers|Those women with a phenotype of intermediate EFV metabolism.
11084619|NCT01494038|OG002|Outcome|Slow Metabolizers|Those women with a phenotype of slow EFV metabolism.
11084620|NCT01494038|OG000|Outcome|Positive IGRA TB Test|Women who had positive IGRA TB test at delivery
11084621|NCT01494038|OG001|Outcome|Negative IGRA TB Test|Women who had negative IGRA TB test at delivery
11084622|NCT01494038|OG000|Outcome|Positive IGRA Test|Infants with positive IGRA test at week 44 postpartum
11084623|NCT01494038|OG001|Outcome|Negative IGRA Tuberculin Test|Infants with a negative IGRA test at 44 weeks postpartum
11084624|NCT01494038|OG000|Outcome|Positive IGRA TB Test|Women who had positive IGRA TB test at 44 weeks postpartum
11084625|NCT01494038|OG001|Outcome|Negative IGRA TB Test|Women who had negative IGRA TB test at 44 weeks postpartum
11084626|NCT01494038|EG000|Reported Event|Mother/Immediate INH|"Women in Arm A received immediate, or antepartum-initiated, INH treatments. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum."
11092079|NCT01537211|FG001|Participant Flow|Mechanical Knee Then Microprocessor Knee|C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees
11092080|NCT01537211|OG000|Outcome|Baseline|Baseline data for participants using their own prosthesis
11092081|NCT01537211|OG001|Outcome|Mechanical Knee|Data collected from while participants used the mechanical knee
11084627|NCT01494038|EG001|Reported Event|Mother/Deferred INH|"Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum.~Isoniazid (INH): 300-mg tablet once daily by month, from Week 12 postpartum through Week 40 postpartum.~Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit."
11084628|NCT01494038|EG002|Reported Event|Infant/Immediate INH|Infants born alive to mothers on arm A (Immediate INH).
11084629|NCT01494038|EG003|Reported Event|Infant/Deferred INH|Infants born alive to mothers on Arm B (Deferred INH).
11084630|NCT01494051|BG000|Baseline|High Carbohydrate Diet|"Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.~Diet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home."
11084631|NCT01494051|BG001|Baseline|High Protein Diet|"Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.~Diet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home."
11084632|NCT01494051|BG002|Baseline|Total|Total of all reporting groups
11084633|NCT01494051|FG000|Participant Flow|High Carbohydrate Diet|"Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.~Diet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home."
11084634|NCT01494051|FG001|Participant Flow|High Protein Diet|"Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.~Diet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home."
11084635|NCT01494051|OG000|Outcome|High Carbohydrate Diet|"Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.~Diet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home."
11084636|NCT01494051|OG001|Outcome|High Protein Diet|"Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.~Diet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home."
11084637|NCT01494051|EG000|Reported Event|High Carbohydrate Diet|"Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.~Diet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home."
11084638|NCT01494051|EG001|Reported Event|High Protein Diet|"Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.~Diet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home."
11084639|NCT01494298|BG000|Baseline|T2DM|African American Men with Type 2 Diabetes
11084640|NCT01494298|BG001|Baseline|Controls|African American Men without diabetes
11084641|NCT01494298|BG002|Baseline|Total|Total of all reporting groups
11084642|NCT01494298|FG000|Participant Flow|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
11084643|NCT01494298|FG001|Participant Flow|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
11084644|NCT01494298|OG000|Outcome|T2DM|
11084645|NCT01494298|OG001|Outcome|Controls|
11084646|NCT01494298|OG000|Outcome|T2DM|African-American men with type 2 diabetes who are not taking cholesterol lowering medications
11084647|NCT01494298|OG001|Outcome|Controls|African-American men without type 2 diabetes who are not taking cholesterol lowering medications
11084648|NCT01494298|EG000|Reported Event|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
11084649|NCT01494298|EG001|Reported Event|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
11084650|NCT01494350|BG000|Baseline|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
11084651|NCT01494350|FG000|Participant Flow|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
11084652|NCT01494350|OG000|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
11084653|NCT01494350|EG000|Reported Event|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
11084654|NCT01494467|BG000|Baseline|CD5024 1% Cream|"Part A: CD5024 1% Cream, once daily application for 12 weeks~Part B: CD5024 1% Cream, once daily application for 40 weeks"
11084655|NCT01494467|BG001|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks~Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
11084656|NCT01494467|BG002|Baseline|Total|Total of all reporting groups
11084657|NCT01494467|FG000|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
11084658|NCT01494467|FG001|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application~Part B: Azelaic acid 15% Gel, twice daily application"
11084659|NCT01494467|OG000|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
11084660|NCT01494467|OG001|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
11084661|NCT01494467|EG000|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
11084662|NCT01494467|EG001|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
11084663|NCT01494467|EG002|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
11084664|NCT01494467|EG003|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
11084665|NCT01494467|EG004|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
11084666|NCT01494467|EG005|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
11084667|NCT01494467|EG006|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
11084668|NCT01494467|EG007|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
11084669|NCT01494506|BG000|Baseline|MM-398|"MM-398 Q3W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W"
11084670|NCT01494506|BG001|Baseline|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
11084671|NCT01494506|BG002|Baseline|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
11084672|NCT01494506|BG003|Baseline|Total|Total of all reporting groups
11084673|NCT01494506|FG000|Participant Flow|MM-398 (Arm A)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
11084674|NCT01494506|FG001|Participant Flow|5-FU + Leucovorin (Arm B)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
11084675|NCT01494506|FG002|Participant Flow|MM-398 + 5-FU + Leucovorin (Arm C)|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
11084676|NCT01494506|OG000|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
11084677|NCT01494506|OG001|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
11084678|NCT01494506|OG002|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
11084679|NCT01494506|OG003|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
11084680|NCT01494506|OG001|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
11084681|NCT01494506|EG000|Reported Event|MM-398|"MM-398 Q3W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W"
11084682|NCT01494506|EG001|Reported Event|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
11084683|NCT01494506|EG002|Reported Event|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
11084684|NCT01494532|BG000|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
11084685|NCT01494532|BG001|Baseline|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084686|NCT01494532|BG002|Baseline|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084687|NCT01494532|BG003|Baseline|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084688|NCT01494532|BG004|Baseline|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084689|NCT01494532|BG005|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084690|NCT01494532|BG006|Baseline|Total|Total of all reporting groups
11084691|NCT01494532|FG000|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
11227765|NCT02386189|OG001|Outcome|Care Coordination|"Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated.~Patient Care Coordination Training: Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated."
11084692|NCT01494532|FG001|Participant Flow|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084693|NCT01494532|FG002|Participant Flow|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084694|NCT01494532|FG003|Participant Flow|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084695|NCT01494532|FG004|Participant Flow|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084696|NCT01494532|FG005|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084697|NCT01494532|OG000|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
11084698|NCT01494532|OG001|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084699|NCT01494532|OG002|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084700|NCT01494532|OG003|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084701|NCT01494532|OG004|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084702|NCT01494532|OG005|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084703|NCT01494532|OG000|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
11084704|NCT01494532|EG000|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
11084705|NCT01494532|EG001|Reported Event|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084706|NCT01494532|EG002|Reported Event|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084707|NCT01494532|EG003|Reported Event|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084708|NCT01494532|EG004|Reported Event|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084709|NCT01494532|EG005|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
11084710|NCT01494545|BG000|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
11084711|NCT01494545|FG000|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
11084712|NCT01494545|OG000|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
11233788|NCT02431260|FG004|Participant Flow|Part 1 / Treatment Group A: 22.5 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11092082|NCT01537211|OG002|Outcome|Microprocessor Knee|Data collected from while participants used the microprocessor knee
11084713|NCT01494545|OG000|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
11084714|NCT01494545|OG001|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
11084715|NCT01494545|OG002|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
11084716|NCT01494545|EG000|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
11084717|NCT01494584|BG000|Baseline|Ezogabine/Retigabine|Participants received an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084718|NCT01494584|FG000|Participant Flow|Ezogabine/Retigabine|Participants recieved an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084719|NCT01494584|OG000|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants (par.) with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084720|NCT01494584|OG001|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084721|NCT01494584|OG002|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11227766|NCT02386189|EG000|Reported Event|Usual Care|Veterans randomized to usual care will not receive any training on using their patient portal(s) to access and share information. They will be contacted via phone and/or secure messaging to remind him/her to take the VA or non-VA provider packet to their appointment. At the conclusion of the study, Veterans assigned to usual care will be provided the training information on the VA health summary for their own reference.
11084722|NCT01494584|OG000|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084723|NCT01494584|OG000|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084724|NCT01494584|OG001|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an uptitrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084725|NCT01494584|OG002|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084726|NCT01494584|OG003|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11092083|NCT01537211|OG000|Outcome|Baseline|Baseline data collected while participants used their own personal prosthesis
11092084|NCT01537211|OG001|Outcome|Post-mechanical Knee|Data collected from after participants used the mechanical knee for six months
11092085|NCT01537211|OG002|Outcome|Post-microprocessor Knee|Data collected from after participants used the microprocessor knee for six months
11227767|NCT02386189|EG001|Reported Event|Care Coordination|"Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated.~Patient Care Coordination Training: Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated."
11227768|NCT02386319|BG000|Baseline|Melatonin|"Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery.~Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.~Melatonin: Gelatin capsules"
11227769|NCT02386319|BG001|Baseline|Placebo|"Gelatin capsules. Anxiolytic and analgesic study. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.~Placebo: Placebo capsules"
11227770|NCT02386319|BG002|Baseline|Total|Total of all reporting groups
11227771|NCT02386319|FG000|Participant Flow|Melatonin|"Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery.~Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.~Melatonin: Gelatin capsules"
11227772|NCT02386319|FG001|Participant Flow|Placebo|"Gelatin capsules. Anxiolytic and analgesic study. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.~Placebo: Placebo capsules"
11227773|NCT02386319|OG000|Outcome|Melatonin|"Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery.~Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.~Melatonin: Gelatin capsules"
11227774|NCT02386319|OG001|Outcome|Placebo|"Gelatin capsules. Anxiolytic and analgesic study. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.~Placebo: Placebo capsules"
11227775|NCT02386319|EG000|Reported Event|Melatonin|"Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery.~Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.~Melatonin: Gelatin capsules"
11084727|NCT01494584|OG004|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084728|NCT01494584|OG001|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084729|NCT01494584|OG003|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of>50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11227776|NCT02386319|EG001|Reported Event|Placebo|"Gelatin capsules. Anxiolytic and analgesic study. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.~Placebo: Placebo capsules"
11092086|NCT01537211|EG000|Reported Event|Microprocessor Knee|The arm reflects time during study participation when the participants were wearing the microprocessor knee.
11092087|NCT01537211|EG001|Reported Event|Mechanical Knee|The arm reflects time during study participation when the participants were wearing the mechanical knee.
11227777|NCT02386345|BG000|Baseline|Registry Population|All patients enrolled in the registry
11227778|NCT02386345|FG000|Participant Flow|Registry Population|All patients enrolled in the registry
11227779|NCT02386345|OG000|Outcome|Analysis Population|All treated patients
11227780|NCT02386345|EG000|Reported Event|Registry Population|All patients enrolled in the registry
11227781|NCT02386605|BG000|Baseline|Treatment|"Motivational Interviewing Treatment group~Motivational Interviewing and Cognitive Behavioral Therapy: group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia"
11227782|NCT02386605|BG001|Baseline|Control|"Relaxation Skills Training group~Relaxation Skills: Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia"
11227783|NCT02386605|BG002|Baseline|Total|Total of all reporting groups
11227784|NCT02386605|FG000|Participant Flow|Treatment|"Motivational Interviewing Treatment group~Motivational Interviewing and Cognitive Behavioral Therapy: group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia"
11227785|NCT02386605|FG001|Participant Flow|Control|"Relaxation Skills Training group~Relaxation Skills: Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia"
11084730|NCT01494584|OG000|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants recieved an initial dose of ezogabine/retigabine 300 mg/day administered as 100 mg IR tablets TID orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084731|NCT01494584|OG000|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly upitration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084732|NCT01494584|OG000|Outcome|Regimen A: Ezogabine/Retigabine (E/R)300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084733|NCT01494584|OG002|Outcome|Regimen A: E/R 300/450/ 600/750 Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084734|NCT01494584|OG000|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084735|NCT01494584|EG000|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084736|NCT01494584|EG001|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084737|NCT01494584|EG002|Reported Event|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084738|NCT01494584|EG003|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084739|NCT01494584|EG004|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
11084740|NCT01494610|BG000|Baseline|FP/Salmeterol 250/50 mcg|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in one of two sequences in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively: ABBA, BAAB. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
11084741|NCT01494610|FG000|Participant Flow|FP/Salmeterol 250/50 mcg: Sequence ABBA|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of ABBA in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
11227786|NCT02386605|OG000|Outcome|Treatment|"Motivational Interviewing Treatment group~Motivational Interviewing and Cognitive Behavioral Therapy: group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia"
11084742|NCT01494610|FG001|Participant Flow|FP/Salmeterol 250/50 mcg: Sequence BAAB|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of BAAB in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
11084743|NCT01494610|OG000|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
11084744|NCT01494610|OG001|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
11084745|NCT01494610|EG000|Reported Event|FP/Salmeterol From MDPI 1st Administration (Admin), Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
11084746|NCT01494610|EG001|Reported Event|FP/Salmeterol From MDPI 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to particiapants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
11084747|NCT01494610|EG002|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
11084748|NCT01494610|EG003|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
11084749|NCT01494610|EG004|Reported Event|FP/Salmeterol From MDPI 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
11084750|NCT01494610|EG005|Reported Event|FP/Salmeterol From MDPI 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
11084751|NCT01494610|EG006|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
11084752|NCT01494610|EG007|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
11084753|NCT01494649|BG000|Baseline|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
11084754|NCT01494649|BG001|Baseline|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
11084755|NCT01494649|BG002|Baseline|Total|Total of all reporting groups
11084756|NCT01494649|FG000|Participant Flow|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
11084757|NCT01494649|FG001|Participant Flow|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
11084758|NCT01494649|OG000|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
11084759|NCT01494649|OG001|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
11084760|NCT01494649|OG001|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
11084761|NCT01494649|OG000|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeths for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
11084762|NCT01494649|EG000|Reported Event|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute, for 14 days twice daily. The test product is a commercially available product.
11084763|NCT01494649|EG001|Reported Event|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
11084764|NCT01494753|BG000|Baseline|Prostaglandin/T2345|One drop at 8.00pm.
11084765|NCT01494753|BG001|Baseline|T2345/Prostaglandin|One drop at 8.00pm.
11084766|NCT01494753|BG002|Baseline|Total|Total of all reporting groups
11084767|NCT01494753|FG000|Participant Flow|Prostaglandin/T2345|One drop at 8.00pm.
11084768|NCT01494753|FG001|Participant Flow|T2345/Prostaglandin|One drop at 8.00pm.
11084769|NCT01494753|OG000|Outcome|Prostaglandin/T2345|One drop at 8.00pm.
11084770|NCT01494753|OG001|Outcome|T2345/Prostaglandin|One drop at 8.00pm.
11084771|NCT01494753|EG000|Reported Event|Prostaglandin|One drop at 8.00pm.
11084772|NCT01494753|EG001|Reported Event|T2345|One drop at 8.00pm.
11092088|NCT01537302|BG000|Baseline|Ocelot System|CTO crossing in femoropopliteal arteries using the Ocelot System
11084773|NCT01494818|BG000|Baseline|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
11084774|NCT01494818|BG001|Baseline|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
11084775|NCT01494818|BG002|Baseline|Total|Total of all reporting groups
11084776|NCT01494818|FG000|Participant Flow|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
11084777|NCT01494818|FG001|Participant Flow|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
11084778|NCT01494818|OG000|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
11084779|NCT01494818|OG001|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
11084780|NCT01494818|EG000|Reported Event|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
11084781|NCT01494818|EG001|Reported Event|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
11084782|NCT01494922|BG000|Baseline|EXC 001 (PF-06473871)|Participants who underwent scar revision surgery on Day 1 and received 4 intradermal injections of EXC 001 (PF-06473871) at a dose of 5 mg/cm at Week 2, 5, 8 and 11 after the surgical incision was closed, to both sides of the incision/scar. Participants received treatment for total scar length of up to 14 cm.
11084783|NCT01494922|FG000|Participant Flow|EXC 001 (PF-06473871)|Participants who underwent scar revision surgery on Day 1 and received 4 intradermal injections of EXC 001 (PF-06473871) at a dose of 5 milligram per centimeter (mg/cm) at Week 2, 5, 8 and 11 after the surgical incision was closed, to both sides of the incision/scar. Participants received treatment for total scar length of up to 14 centimeter (cm).
11084784|NCT01494922|OG000|Outcome|EXC 001 (PF-06473871)|Participants who underwent scar revision surgery on Day 1 and received 4 intradermal injections of EXC 001 (PF-06473871) at a dose of 5 mg/cm at Week 2, 5, 8 and 11 after the surgical incision was closed, to both sides of the incision/scar. Participants received treatment for total scar length of up to 14 cm.
11084785|NCT01494922|EG000|Reported Event|EXC 001 (PF-06473871)|Participants who underwent scar revision surgery on Day 1 and received 4 intradermal injections of EXC 001 (PF-06473871) at a dose of 5 mg/cm at Week 2, 5, 8 and 11 after the surgical incision was closed, to both sides of the incision/scar. Participants received treatment for total scar length of up to 14 cm.
11084786|NCT01494987|BG000|Baseline|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11084787|NCT01494987|BG001|Baseline|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
11084788|NCT01494987|BG002|Baseline|Total|Total of all reporting groups
11084789|NCT01494987|FG000|Participant Flow|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11084790|NCT01494987|FG001|Participant Flow|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
11084791|NCT01494987|OG000|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11092089|NCT01537302|FG000|Participant Flow|Ocelot System|CTO crossing in femoropopliteal arteries using the Ocelot System
11092090|NCT01537302|OG000|Outcome|Ocelot System|CTO crossing in femoropopliteal arteries using the Ocelot System
11092091|NCT01537302|EG000|Reported Event|Ocelot System|CTO crossing in femoropopliteal arteries using the Ocelot System
11084792|NCT01494987|OG001|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
11084793|NCT01494987|EG000|Reported Event|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
11084794|NCT01494987|EG001|Reported Event|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
11084795|NCT01495000|BG000|Baseline|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
11084796|NCT01495000|BG001|Baseline|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
11084797|NCT01495000|BG002|Baseline|Total|Total of all reporting groups
11084798|NCT01495000|FG000|Participant Flow|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
11084799|NCT01495000|FG001|Participant Flow|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
11084800|NCT01495000|OG000|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
11084801|NCT01495000|OG001|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
11084802|NCT01495000|EG000|Reported Event|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
11084803|NCT01495000|EG001|Reported Event|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
11084804|NCT01495221|BG000|Baseline|Intravitreal Aflibercept|"All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.~Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection."
11084805|NCT01495221|FG000|Participant Flow|Intravitreal Aflibercept|"All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.~Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection."
11084806|NCT01495221|OG000|Outcome|Intravitreal Aflibercept|"All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.~Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection."
11084807|NCT01495221|EG000|Reported Event|Intravitreal Aflibercept|"All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.~Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection."
11227787|NCT02386605|OG001|Outcome|Control|"Relaxation Skills Training group~Relaxation Skills: Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia"
11084808|NCT01495286|BG000|Baseline|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
11084809|NCT01495286|FG000|Participant Flow|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
11084810|NCT01495286|OG000|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
11084811|NCT01495286|EG000|Reported Event|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
11084812|NCT01495481|BG000|Baseline|Adenosine and Dexmedetomidine|Patients will receive both adenosine and dexmedetomidine for the termination of SVT.
11084813|NCT01495481|FG000|Participant Flow|Adenosine and Dexmedetomidine|Patients will receive adenosine for termination of SVT, and then dexmedetomidine for the termination of supraventricular tachycardia (SVT) and comparison will be made for efficacy and safety.
11084814|NCT01495481|OG000|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of SVT~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
11084815|NCT01495481|OG001|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
11084816|NCT01495481|OG000|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)~Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push"
11084817|NCT01495481|OG000|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
11084818|NCT01495481|EG000|Reported Event|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of SVT~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
11084819|NCT01495481|EG001|Reported Event|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
11084820|NCT01495572|BG000|Baseline|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11084821|NCT01495572|BG001|Baseline|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11084822|NCT01495572|BG002|Baseline|Total|Total of all reporting groups
11084823|NCT01495572|FG000|Participant Flow|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11227788|NCT02386605|EG000|Reported Event|Treatment|"Motivational Interviewing Treatment group~Motivational Interviewing and Cognitive Behavioral Therapy: group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia"
11227789|NCT02386605|EG001|Reported Event|Control|"Relaxation Skills Training group~Relaxation Skills: Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia"
11084824|NCT01495572|FG001|Participant Flow|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11084825|NCT01495572|OG000|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11084826|NCT01495572|OG001|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11084827|NCT01495572|OG001|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x1011 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11084828|NCT01495572|EG000|Reported Event|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11084829|NCT01495572|EG001|Reported Event|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
11084830|NCT01495585|BG000|Baseline|Placebo|placebo control.
11084831|NCT01495585|BG001|Baseline|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
11084832|NCT01495585|BG002|Baseline|Lonafarnib 200 mg|"4 participants were randomized to Lonafarnib 200 mg and two Placebo participants in Lonafarnib 100 mg arm received open label lonafarnib 200 mg ."
11084833|NCT01495585|BG003|Baseline|Total|Total of all reporting groups
11084834|NCT01495585|FG000|Participant Flow|Placebo|Two placebo participants in Group1 and two placebo participants in Group 2. The two placebo participants in Group 1 received open label lonafarnib 200 mg.
11084835|NCT01495585|FG001|Participant Flow|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
11084836|NCT01495585|FG002|Participant Flow|Lonafarnib 200 mg|4 participants were randomized to Lonafarnib 200 mg.
11084837|NCT01495585|OG000|Outcome|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
11084838|NCT01495585|OG001|Outcome|Group 1|lonafarnib 100 mg
11084839|NCT01495585|OG002|Outcome|Group 2|lonafarnib 200 mg
11084840|NCT01495585|EG000|Reported Event|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
11084841|NCT01495585|EG001|Reported Event|Group 1|lonafarnib 100 mg
11084842|NCT01495585|EG002|Reported Event|Group 2|lonafarnib 200 mg
11084843|NCT01495689|BG000|Baseline|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
11084844|NCT01495689|BG001|Baseline|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
11084845|NCT01495689|BG002|Baseline|Total|Total of all reporting groups
11084846|NCT01495689|FG000|Participant Flow|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
11084847|NCT01495689|FG001|Participant Flow|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
11084848|NCT01495689|OG000|Outcome|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
11084849|NCT01495689|OG001|Outcome|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
11084850|NCT01495689|EG000|Reported Event|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
11084851|NCT01495689|EG001|Reported Event|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
11084852|NCT01495702|BG000|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
11084853|NCT01495702|BG001|Baseline|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
11084854|NCT01495702|BG002|Baseline|Total|Total of all reporting groups
11084855|NCT01495702|FG000|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
11084856|NCT01495702|FG001|Participant Flow|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
11084857|NCT01495702|OG000|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
11084858|NCT01495702|OG001|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
11084859|NCT01495702|EG000|Reported Event|Stribild (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.~Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
11084860|NCT01495702|EG001|Reported Event|NNRTI+FTC/TDF (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving NNRTI+FTC/TDF in the randomized phase.~Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
11084861|NCT01495702|EG002|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.
11084862|NCT01495793|BG000|Baseline|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
11084863|NCT01495793|FG000|Participant Flow|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
11084864|NCT01495793|OG000|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
11084865|NCT01495793|EG000|Reported Event|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
11084866|NCT01495819|BG000|Baseline|Study Participants|In this crossover study, all participants received all 5 treatments, including placebo.
11084867|NCT01495819|FG000|Participant Flow|Study Participants|subjects will be randomly assigned to one of the five doses of nicotine (0.0125, 0.025, 0.0.5, 0.1 and 0.2 mg/70 kg or about 0.18, 0.36, 0.7, 1.4 and 2.8 µg/kg). At the beginning of each experimental session, subjects will first sample the assigned nicotine dose and placebo (saline) condition that are randomly labeled as A or B. which may be nicotine or saline. This procedure will allow subjects to sample the nicotine and saline that will be available during that session. In addition, subjective and physiological responses to the sample nicotine dose and saline will be assessed.
11084868|NCT01495819|OG000|Outcome|Study Participants|In this crossover study, all participants received all 5 treatments, including placebo.
11084869|NCT01495819|EG000|Reported Event|Saline|In this crossover study, all participants received all 5 treatments, including placebo.
11084870|NCT01495819|EG001|Reported Event|Nicotine 0.0125|All participants received 0.0125
11227790|NCT02386995|BG000|Baseline|BIS and Entropy Monitoring|"Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.~BIS monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.~Entropy monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia"
11084871|NCT01495819|EG002|Reported Event|Nicotine 0.025|All participants received 0.025
11084872|NCT01495819|EG003|Reported Event|Nicotine 0.05|All participants received 0.05
11084873|NCT01495819|EG004|Reported Event|Nicotine 0.1|All Participants received 0.1
11084874|NCT01495819|EG005|Reported Event|Nicotine 0.2|All participants received 0.2
11084875|NCT01495858|BG000|Baseline|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
11084876|NCT01495858|BG001|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
11084877|NCT01495858|BG002|Baseline|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
11084878|NCT01495858|BG003|Baseline|Total|Total of all reporting groups
11084879|NCT01495858|FG000|Participant Flow|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
11084880|NCT01495858|FG001|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
11084881|NCT01495858|FG002|Participant Flow|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
11084882|NCT01495858|OG000|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
11084883|NCT01495858|OG001|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
11084884|NCT01495858|OG002|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
11084885|NCT01495858|EG000|Reported Event|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally
11084886|NCT01495858|EG001|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally
11084887|NCT01495858|EG002|Reported Event|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
11084888|NCT01495923|BG000|Baseline|Epidural Steriod Injections|Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive a real epidural steroid injection and placebo medication as treatment.
11084889|NCT01495923|BG001|Baseline|Gabapentin|Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive real gabapentin and a placebo injection as treatment.
11084890|NCT01495923|BG002|Baseline|Total|Total of all reporting groups
11084891|NCT01495923|FG000|Participant Flow|Epidural Steroid Injection|If randomized to this group, participants received either a transforaminal injection for unilateral pain or an interlaminar injection for bilateral pain and placebo medication. The level and type of injection to be given was determined by signs, symptoms, and radiological findings.
11084892|NCT01495923|FG001|Participant Flow|Gabapentin|If randomized to this group participants received gabapentin medication and a placebo intramuscular injection. The gabapentin was uptitrated to a therapeutic dose using a titration schedule.
11084893|NCT01495923|OG000|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
11084894|NCT01495923|OG001|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
11084895|NCT01495923|OG000|Outcome|Gabapentin Group|This group received gabapentin and a placebo intramuscular injection.
11084896|NCT01495923|OG001|Outcome|Epidural Steroid|This group received an epidural steroid injection and placebo gabapentin.
11084897|NCT01495923|EG000|Reported Event|Epidural Steroids|"Injection of steroids into the epidural space~epidural steroid injection: Injection of steroids and local anesthetic into the epidural space~Placebo gabapentin: Titration of placebo gabapentin"
11084898|NCT01495923|EG001|Reported Event|Gabapentin|"Titration of gabapentin to effect~Sham epidural steroid injection: Injection of saline into the back muscles~Gabapentin: Titration of gabapentin to effect"
11084899|NCT01495975|BG000|Baseline|Usual Care|Usual care for diabetes in the 1 month after discharge.
11084900|NCT01495975|BG001|Baseline|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
11084901|NCT01495975|BG002|Baseline|Total|Total of all reporting groups
11084902|NCT01495975|FG000|Participant Flow|Usual Care|Usual care for diabetes in the 1 month after discharge.
11084903|NCT01495975|FG001|Participant Flow|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
11084904|NCT01495975|OG000|Outcome|Usual Care|Usual care for diabetes in the 1 month after discharge.
11084905|NCT01495975|OG001|Outcome|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
11084906|NCT01495975|EG000|Reported Event|Usual Care|Usual care for diabetes in the 1 month after discharge.
11084907|NCT01495975|EG001|Reported Event|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
11084908|NCT01496066|BG000|Baseline|LAL Implant|"LAL implanted~LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD"
11084909|NCT01496066|BG001|Baseline|Monofocal Control|"Monofocal control IOL implanted~Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)"
11084910|NCT01496066|BG002|Baseline|Total|Total of all reporting groups
11084911|NCT01496066|FG000|Participant Flow|LAL Implant|"LAL implanted~LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD"
11084912|NCT01496066|FG001|Participant Flow|Monofocal Control|"Monofocal control IOL implanted~Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)"
11084913|NCT01496066|OG000|Outcome|Light Adjustable Lens Implanted|Randomized to have the Light Adjustable Lens implanted
11084914|NCT01496066|OG001|Outcome|Control IOL Implanted|Randomized to have the monofocal control IOL implanted
11084915|NCT01496066|OG000|Outcome|Light Adjustable Lens|Eyes randomized to have Light Adjustable Lens implanted
11084916|NCT01496066|OG001|Outcome|Monofocal Control IOL|Eyes randomized to have monofocal control IOL implanted
11084917|NCT01496066|OG000|Outcome|Light Adjustable Lens|Eyes randomized to be implanted with the Light Adjustable Lens
11084918|NCT01496066|OG000|Outcome|Light Adjustable Lens|Randomized to have the Light Adjustable Lens implanted
11084919|NCT01496066|OG001|Outcome|Monofocal Control IOL|Randomized to have a Monofocal control IOL implanted
11084920|NCT01496066|OG001|Outcome|Monofocal Control IOL|Randomized to have the monofocal control IOL implanted
11084921|NCT01496066|OG001|Outcome|Monofocal Control IOL|Randomized to have the Monofocal control IOL implanted
11084922|NCT01496066|EG000|Reported Event|Light Adjustable Lens|Randomized to have the Light Adjustable Lens implanted
11084923|NCT01496066|EG001|Reported Event|Monofocal Control IOL|Randomized to have the Monofocal control IOL implanted
11084924|NCT01496131|BG000|Baseline|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
11084925|NCT01496131|BG001|Baseline|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
11084926|NCT01496131|BG002|Baseline|Total|Total of all reporting groups
11084927|NCT01496131|FG000|Participant Flow|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after Androgen Deprivation Therapy (ADT).
11084928|NCT01496131|FG001|Participant Flow|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
11084929|NCT01496131|OG000|Outcome|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
11084930|NCT01496131|OG001|Outcome|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
11084931|NCT01496131|EG000|Reported Event|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
11084932|NCT01496131|EG001|Reported Event|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
11084933|NCT01496157|BG000|Baseline|Patients With Primary Prostate Cancer|"Patients will be imaged with 18F-DCFBC~18F-DCFBC: A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push."
11084934|NCT01496157|FG000|Participant Flow|Patients With Primary Prostate Cancer|"Patients will be imaged with 18F-DCFBC~18F-DCFBC: A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push."
11084935|NCT01496157|OG000|Outcome|Patients With Primary Prostate Cancer|"Patients will be imaged with 18F-DCFBC~18F-DCFBC: A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push."
11084936|NCT01496157|EG000|Reported Event|Patients With Primary Prostate Cancer|"Patients will be imaged with 18F-DCFBC~18F-DCFBC: A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push."
11084937|NCT01496183|BG000|Baseline|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
11084938|NCT01496183|BG001|Baseline|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
11084939|NCT01496183|BG002|Baseline|Total|Total of all reporting groups
11084940|NCT01496183|FG000|Participant Flow|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
11084941|NCT01496183|FG001|Participant Flow|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
11084942|NCT01496183|OG000|Outcome|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.
11084943|NCT01496183|OG001|Outcome|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
11084944|NCT01496183|OG000|Outcome|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
11084945|NCT01496183|EG000|Reported Event|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
11084946|NCT01496183|EG001|Reported Event|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
11084947|NCT01496248|BG000|Baseline|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
11084948|NCT01496248|FG000|Participant Flow|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
11084949|NCT01496248|OG000|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
11084950|NCT01496248|EG000|Reported Event|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
11084951|NCT01496274|BG000|Baseline|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention.~rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
11084952|NCT01496274|BG001|Baseline|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention.~rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
11084953|NCT01496274|BG002|Baseline|Total|Total of all reporting groups
11084954|NCT01496274|FG000|Participant Flow|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention."
11084955|NCT01496274|FG001|Participant Flow|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention."
11084956|NCT01496274|OG000|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
11084957|NCT01496274|OG001|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
11084958|NCT01496274|OG000|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
11084959|NCT01496274|OG000|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention."
11084960|NCT01496274|OG001|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention."
11084961|NCT01496274|OG002|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
11084962|NCT01496274|OG001|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
11084963|NCT01496274|OG002|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
11084964|NCT01496274|OG000|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
11084965|NCT01496274|OG001|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
11084966|NCT01496274|OG002|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
11084967|NCT01496274|OG003|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
11084968|NCT01496274|OG001|Outcome|On-demand|"Episodic treatment for bleeding episodes up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention."
11084969|NCT01496274|OG000|Outcome|Surgical Population|The Surgical population consisted of 3 subjects in the prophylaxis arm and 1 subject in the on demand arm who received at least 1 dose of rIX FP for a major or minor surgical procedure.
11084970|NCT01496274|OG000|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
11084971|NCT01496274|OG001|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
11084972|NCT01496274|OG002|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
11084973|NCT01496274|EG000|Reported Event|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention."
11084974|NCT01496274|EG001|Reported Event|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention."
11084975|NCT01496287|BG000|Baseline|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
11084976|NCT01496287|FG000|Participant Flow|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
11084977|NCT01496287|OG000|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
11084978|NCT01496287|OG000|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
11084979|NCT01496287|EG000|Reported Event|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
11084980|NCT01496313|BG000|Baseline|Vandetanib 150 mg|Oral blinded tablet, taken once daily
11084981|NCT01496313|BG001|Baseline|Vandetanib 300 mg|Oral blinded tablet, taken once daily
11084982|NCT01496313|BG002|Baseline|Total|Total of all reporting groups
11084983|NCT01496313|FG000|Participant Flow|Vandetanib 150 mg|Oral blinded tablet, taken once daily
11084984|NCT01496313|FG001|Participant Flow|Vandetanib 300 mg|Oral blinded tablet, taken once daily
11084985|NCT01496313|OG000|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
11084986|NCT01496313|OG001|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
11084987|NCT01496313|EG000|Reported Event|Vandetanib 150 mg|Oral blinded tablet, taken once daily
11233789|NCT02431260|FG005|Participant Flow|Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329|"Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.~Treatment Group A included any advanced solid tumor or lymphoma."
11084988|NCT01496313|EG001|Reported Event|Vandetanib 300 mg|Oral blinded tablet, taken once daily
11084989|NCT01496352|BG000|Baseline|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
11084990|NCT01496352|BG001|Baseline|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
11084991|NCT01496352|BG002|Baseline|Total|Total of all reporting groups
11084992|NCT01496352|FG000|Participant Flow|DFA-02|"Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02~DFA-02: Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure"
11084993|NCT01496352|FG001|Participant Flow|DFA-02 Placebo|Progressive cohorts of 2 patients per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
11084994|NCT01496352|OG000|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
11084995|NCT01496352|OG001|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
11084996|NCT01496352|OG000|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
11084997|NCT01496352|OG001|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
11084998|NCT01496352|OG000|Outcome|DFA-02|Progressive cohorts of 18 subjects receiving up to 10, 20 or 30 mL of DFA-02
11084999|NCT01496352|OG001|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 and 30 mL of DFA-02 placebo
11085000|NCT01496352|OG000|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
11085001|NCT01496352|OG001|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving 10, 20 or 30 mL DFA-02 placebo
11085002|NCT01496352|OG001|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subject per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
11085003|NCT01496352|OG000|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL DFA-02
11085004|NCT01496352|OG001|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
11085005|NCT01496352|EG000|Reported Event|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
11085006|NCT01496352|EG001|Reported Event|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
11085007|NCT01496365|BG000|Baseline|Placebo|Participants who were randomized to placebo.
11085008|NCT01496365|BG001|Baseline|Pregabalin 150 mg BID|Participants who were randomized to pregabalin 150 mg twice daily (BID).
11085009|NCT01496365|BG002|Baseline|DS-5565 5mg QD|Participants who were randomized to DS-5565 5 mg every day (QD).
11085010|NCT01496365|BG003|Baseline|DS-5565 10 mg QD|Participants who were randomized to DS-5565 10 mg every day (QD).
11085011|NCT01496365|BG004|Baseline|DS-5565 15 mg QD|Participants who were randomized to DS-5565 15 mg every day (QD).
11085012|NCT01496365|BG005|Baseline|DS-5565 10 mg BID|Participants who were randomized to DS-5565 10 mg twice daily (BID).
11085013|NCT01496365|BG006|Baseline|DS-5565 15 mg BID|Participants who were randomized to DS-5565 15 mg twice daily (BID).
11085014|NCT01496365|BG007|Baseline|Total|Total of all reporting groups
11085015|NCT01496365|FG000|Participant Flow|Placebo|Participants who were randomized to placebo.
11085016|NCT01496365|FG001|Participant Flow|Pregabalin 150 mg BID|Participants who were randomized to pregabalin 150 mg twice daily (BID).
11085017|NCT01496365|FG002|Participant Flow|DS-5565 5mg QD|Participants who were randomized to DS-5565 5 mg every day (QD).
11085018|NCT01496365|FG003|Participant Flow|DS-5565 10 mg QD|Participants who were randomized to DS-5565 10 mg every day (QD).
11085019|NCT01496365|FG004|Participant Flow|DS-5565 15 mg QD|Participants who were randomized to DS-5565 15 mg every day (QD).
11085020|NCT01496365|FG005|Participant Flow|DS-5565 10 mg BID|Participants who were randomized to DS-5565 10 mg twice daily (BID).
11085021|NCT01496365|FG006|Participant Flow|DS-5565 15 mg BID|Participants who were randomized to DS-5565 15 mg twice daily (BID).
11085022|NCT01496365|OG000|Outcome|Placebo|Participants who were randomized to placebo.
11085023|NCT01496365|OG001|Outcome|Pregabalin 150 mg BID|Participants who were randomized to pregabalin 150 mg twice daily (BID).
11085024|NCT01496365|OG002|Outcome|DS-5565 5mg QD|Participants who were randomized to DS-5565 5 mg every day (QD).
11085025|NCT01496365|OG003|Outcome|DS-5565 10 mg QD|Participants who were randomized to DS-5565 10 mg every day (QD).
11085026|NCT01496365|OG004|Outcome|DS-5565 15 mg QD|Participants who were randomized to DS-5565 15 mg every day (QD).
11085027|NCT01496365|OG005|Outcome|DS-5565 10 mg BID|Participants who were randomized to DS-5565 10 mg twice daily (BID).
11085028|NCT01496365|OG006|Outcome|DS-5565 15 mg BID|Participants who were randomized to DS-5565 15 mg twice daily (BID).
11085029|NCT01496365|EG000|Reported Event|Placebo|Participants who were randomized to placebo.
11085030|NCT01496365|EG001|Reported Event|Pregabalin 150 mg BID|Participants who were randomized to pregabalin 150 mg twice daily (BID).
11085031|NCT01496365|EG002|Reported Event|DS-5565 5mg QD|Participants who were randomized to DS-5565 5 mg every day (QD).
11085032|NCT01496365|EG003|Reported Event|DS-5565 10 mg QD|Participants who were randomized to DS-5565 10 mg every day (QD).
11085033|NCT01496365|EG004|Reported Event|DS-5565 15 mg QD|Participants who were randomized to DS-5565 15 mg every day (QD).
11085034|NCT01496365|EG005|Reported Event|DS-5565 10 mg BID|Participants who were randomized to DS-5565 10 mg twice daily (BID).
11085035|NCT01496365|EG006|Reported Event|DS-5565 15 mg BID|Participants who were randomized to DS-5565 15 mg twice daily (BID).
11085036|NCT01496430|BG000|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
11085037|NCT01496430|BG001|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
11085038|NCT01496430|BG002|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
11085039|NCT01496430|BG003|Baseline|Total|Total of all reporting groups
11085040|NCT01496430|FG000|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
11085041|NCT01496430|FG001|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
11085042|NCT01496430|FG002|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
11085043|NCT01496430|OG000|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
11085044|NCT01496430|OG001|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
11085045|NCT01496430|OG002|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
11085046|NCT01496430|EG000|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
11085047|NCT01496430|EG001|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
11085048|NCT01496430|EG002|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
11085049|NCT01496456|BG000|Baseline|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements"
11085050|NCT01496456|FG000|Participant Flow|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth).~A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only.~--- Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements."
11085051|NCT01496456|OG000|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
11085052|NCT01496456|OG001|Outcome|Preventative Measures|SOC Caries management by preventative measures only.
11085053|NCT01496456|OG001|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation~Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
11085054|NCT01496456|EG000|Reported Event|Lesion Infiltration|"Resin infiltration of caries lesion in addition to SOC caries management by preventative measures~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
11085055|NCT01496456|EG001|Reported Event|Preventative Measures|"Caries management by preventative measures only~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
11085056|NCT01496469|BG000|Baseline|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
11085057|NCT01496469|BG001|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
11085058|NCT01496469|BG002|Baseline|Total|Total of all reporting groups
11085059|NCT01496469|FG000|Participant Flow|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
11085060|NCT01496469|FG001|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
11085061|NCT01496469|OG000|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
11085062|NCT01496469|OG001|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
11085063|NCT01496469|EG000|Reported Event|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
11085064|NCT01496469|EG001|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
11092092|NCT01537315|BG000|Baseline|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
11092093|NCT01537315|BG001|Baseline|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
11092094|NCT01537315|BG002|Baseline|Total|Total of all reporting groups
11092095|NCT01537315|FG000|Participant Flow|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
11092096|NCT01537315|FG001|Participant Flow|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
11092097|NCT01537315|OG000|Outcome|Matching Placebo|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching placebo capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
11092098|NCT01537315|OG001|Outcome|Hydroxychloroquine|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or matching placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
11092099|NCT01537315|EG000|Reported Event|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
11092100|NCT01537315|EG001|Reported Event|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
11092101|NCT01537367|BG000|Baseline|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient related to making and seeing clinic appointments.
11092102|NCT01537367|BG001|Baseline|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
11092103|NCT01537367|BG002|Baseline|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
11092104|NCT01537367|BG003|Baseline|Total|Total of all reporting groups
11092105|NCT01537367|FG000|Participant Flow|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
11092106|NCT01537367|FG001|Participant Flow|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
11092107|NCT01537367|FG002|Participant Flow|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
11092108|NCT01537367|OG000|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
11233790|NCT02431260|FG006|Participant Flow|Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11233791|NCT02431260|FG007|Participant Flow|Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11085065|NCT01496612|BG000|Baseline|All Participants|All participants enrolled in the study
11085066|NCT01496612|FG000|Participant Flow|Buspirone Then Placebo|Participants were administered Buspirone, followed by a washout period, and then administered Placebo
11085067|NCT01496612|FG001|Participant Flow|Placebo Then Buspirone|Participants were administered Placebo, followed by a washout period, and then administered Buspirone
11085068|NCT01496612|OG000|Outcome|Buspirone|Participants with epilepsy receiving Buspirone
11085069|NCT01496612|OG001|Outcome|Placebo|Participants with epilepsy receiving Placebo
11085070|NCT01496612|EG000|Reported Event|Buspirone|Events occurring while participants on Buspirone x3 months
11085071|NCT01496612|EG001|Reported Event|Washout Period Following Buspirone|Events occurring during the washout period following 3 months of Buspirone
11085072|NCT01496612|EG002|Reported Event|Placebo|Events occurring while participants were taking Placebo x3 months
11085073|NCT01496612|EG003|Reported Event|Washout Period Following Placebo|Events occurring during the washout period following 3 months of Placebo
11227791|NCT02386995|FG000|Participant Flow|BIS and Entropy Monitoring|"Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.~BIS monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.~Entropy monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia"
11227792|NCT02386995|OG000|Outcome|Bispectral Index BIS|The trends of Bispectral index (BIS) at different study time points (T)
11227793|NCT02386995|OG001|Outcome|Response Entropy Index|The trends of Response Entropy index (RE) at different study time points (T)
11085074|NCT01496807|BG000|Baseline|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
11085075|NCT01496807|FG000|Participant Flow|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
11085076|NCT01496807|OG000|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
11085077|NCT01496807|EG000|Reported Event|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
11233792|NCT02431260|FG008|Participant Flow|Part 1 / Treatment Group A: 20 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11085078|NCT01496846|BG000|Baseline|IANB Articaine Only - 1st Molar|IANB anesthesia with articaine local anesthetic provided to 1st Molar
11085079|NCT01496846|BG001|Baseline|IANB Articaine Only - 2nd Molar|IANB anesthesia with articaine local anesthetic provided to 2nd Molar
11085080|NCT01496846|BG002|Baseline|IANB Articaine and SUP Articaine - 1st Molar|Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
11085081|NCT01496846|BG003|Baseline|IANB Articaine and SUP Articaine - 2nd Molar|Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
11085082|NCT01496846|BG004|Baseline|IANB Articaine and SUP Lidocaine - 1st Molar|Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
11085083|NCT01496846|BG005|Baseline|IANB Articaine and SUP Lidocaine - 2nd Molar|Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
11085084|NCT01496846|BG006|Baseline|Total|Total of all reporting groups
11085085|NCT01496846|FG000|Participant Flow|IANB Articaine Only - 1st Molar|IANB anesthesia with articaine local anesthetic provided to 1st Molar.
11085086|NCT01496846|FG001|Participant Flow|IANB Articaine Only - 2nd Molar|IANB anesthesia with articaine local anesthetic provided to 2nd Molar.
11085087|NCT01496846|FG002|Participant Flow|IANB Articaine and SUP Articaine - 1st Molar|Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
11085088|NCT01496846|FG003|Participant Flow|IANB Articaine and SUP Articaine - 2nd Molar|Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
11085089|NCT01496846|FG004|Participant Flow|IANB Articaine and SUP Lidocaine - 1st Molar|Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
11085090|NCT01496846|FG005|Participant Flow|IANB Articaine and SUP Lidocaine - 2nd Molar|Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
11085091|NCT01496846|OG000|Outcome|IANB Articaine and SUP Articaine - 1st Molar|Supplemental buccal anesthesia with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
11085092|NCT01496846|OG001|Outcome|IANB Articaine and SUP Articaine - 2nd Molar|Supplemental buccal anesthesia with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
11085093|NCT01496846|OG002|Outcome|IANB Articaine and SUP Lidocaine - 1st Molar|Supplemental buccal anesthesia with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
11085094|NCT01496846|OG003|Outcome|IANB Articaine and SUP Lidocaine - 2nd Molar|Supplemental buccal anesthesia with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
11085095|NCT01496846|OG000|Outcome|IANB Articaine - 1st Molar|Initial IANB (1.7cc 4% articaine with 1:100,000 epinephrine) provided to 1st Molar.
11085096|NCT01496846|OG001|Outcome|IANB Articaine - 2nd Molar|Initial IANB (1.7cc 4% articaine with 1:100,000 epinephrine) provided to 2nd Molar.
11085097|NCT01496846|EG000|Reported Event|Initial IANB Articaine|Initial IANB with articaine local anesthetic.
11085098|NCT01496846|EG001|Reported Event|SUP Articaine|Supplemental buccal anesthesia with articaine local anesthetic.
11085099|NCT01496846|EG002|Reported Event|SUP Lidocaine|Supplemental buccal anesthesia with lidocaine local anesthetic.
11085100|NCT01496885|BG000|Baseline|All Participants|Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
11085101|NCT01496885|FG000|Participant Flow|All Participants|Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
11085102|NCT01496885|OG000|Outcome|All Participants|Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
11085103|NCT01496885|EG000|Reported Event|All Participants|Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
11085104|NCT01497067|BG000|Baseline|CACHET|ACRYSOF CACHET Phakic Lens (L-series) previously implanted
11085105|NCT01497067|FG000|Participant Flow|CACHET|ACRYSOF CACHET Phakic Lens (L-series) previously implanted
11085106|NCT01497067|OG000|Outcome|CACHET|ACRYSOF CACHET Phakic Lens (L-series) previously implanted
11085107|NCT01497067|EG000|Reported Event|CACHET - Ocular|All eyes previously implanted with ACRYSOF CACHET Phakic Lens (L-series)
11085108|NCT01497067|EG001|Reported Event|CACHET - Systemic|All subjects previously implanted with ACRYSOF CACHET Phakic Lens (L-series)
11085109|NCT01497197|BG000|Baseline|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
11085110|NCT01497197|BG001|Baseline|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
11233793|NCT02431260|FG009|Participant Flow|Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11085111|NCT01497197|BG002|Baseline|Total|Total of all reporting groups
11085112|NCT01497197|FG000|Participant Flow|Gonal-f®+Luveris|GONAL f® (Liquid Pen; 300 international units [IU] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice.
11085113|NCT01497197|FG001|Participant Flow|Gonal-f® Followed by Luveris|GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice.
11085114|NCT01497197|OG000|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
11085115|NCT01497197|OG001|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
11085116|NCT01497197|EG000|Reported Event|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
11085117|NCT01497197|EG001|Reported Event|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
11085118|NCT01497262|BG000|Baseline|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
11085119|NCT01497262|FG000|Participant Flow|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
11085120|NCT01497262|OG000|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
11085121|NCT01497262|EG000|Reported Event|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
11085122|NCT01497275|BG000|Baseline|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
11085123|NCT01497275|FG000|Participant Flow|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
11085124|NCT01497275|OG000|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
11085125|NCT01497275|EG000|Reported Event|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
11085126|NCT01497366|BG000|Baseline|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
11085127|NCT01497366|BG001|Baseline|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
11085128|NCT01497366|BG002|Baseline|Total|Total of all reporting groups
11085129|NCT01497366|FG000|Participant Flow|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
11085130|NCT01497366|FG001|Participant Flow|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
11085131|NCT01497366|OG000|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
11085132|NCT01497366|OG001|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
11085133|NCT01497366|OG000|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
11085134|NCT01497366|EG000|Reported Event|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
11085135|NCT01497366|EG001|Reported Event|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
11085136|NCT01497496|BG000|Baseline|Immunotherapy|"Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab.~High Dose Methylprednisolone (HDMP): 1000 mg/m^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15~Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1~Lenalidomide: The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)"
11085137|NCT01497496|FG000|Participant Flow|Immunotherapy|Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab. Time of therapy: until disease progression or toxicity.
11085138|NCT01497496|OG000|Outcome|Immunotherapy|"Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab.~High Dose Methylprednisolone (HDMP): 1000 mg/m^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15~Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1~Lenalidomide: The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)"
11085139|NCT01497496|EG000|Reported Event|Immunotherapy|"Combination regimen consisting of high dose methylprednisolone combined with ofatumumab, followed by consolidative therapy with lenalidomide in combination with ofatumumab.~High Dose Methylprednisolone (HDMP): 1000 mg/m^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15~Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1~Lenalidomide: The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)"
11085140|NCT01497613|BG000|Baseline|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
11085141|NCT01497613|BG001|Baseline|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
11085142|NCT01497613|BG002|Baseline|Total|Total of all reporting groups
11085143|NCT01497613|FG000|Participant Flow|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
11085144|NCT01497613|FG001|Participant Flow|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
11085145|NCT01497613|OG000|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
11233794|NCT02431260|FG010|Participant Flow|Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11085146|NCT01497613|OG001|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
11085147|NCT01497613|EG000|Reported Event|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
11085148|NCT01497613|EG001|Reported Event|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
11085149|NCT01497665|BG000|Baseline|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
11085150|NCT01497665|FG000|Participant Flow|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
11085151|NCT01497665|OG000|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
11085152|NCT01497665|EG000|Reported Event|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
11085153|NCT01497756|BG000|Baseline|CAPP Application|Patients in whom device is used
11085154|NCT01497756|FG000|Participant Flow|CAPP Application|Patients in whom device is used
11085155|NCT01497756|OG000|Outcome|CAPP Application|Patients in whom device is used
11085156|NCT01497756|EG000|Reported Event|CAPP Application|Patients in whom device is used
11085157|NCT01497808|BG000|Baseline|Ipilimumab and Radiotherapy (8 Gy x 2)|"Ipilimumab~Stereotactic Body Radiation Therapy"
11085158|NCT01497808|BG001|Baseline|Ipilimumab and Radiotherapy (8 Gy x 3)|
11085159|NCT01497808|BG002|Baseline|Ipilimumab and Radiotherapy (6 Gy x 2)|
11085160|NCT01497808|BG003|Baseline|Ipilimumab and Radiotherapy (6 Gy x 3)|
11085161|NCT01497808|BG004|Baseline|Total|Total of all reporting groups
11085162|NCT01497808|FG000|Participant Flow|Ipilimumab and Radiotherapy (8 Gy x 2)|"Ipilimumab~Stereotactic Body Radiation Therapy"
11085163|NCT01497808|FG001|Participant Flow|Ipilimumab and Radiotherapy (8 Gy x 3)|
11085164|NCT01497808|FG002|Participant Flow|Ipilimumab and Radiotherapy (6 Gy x 2)|
11085165|NCT01497808|FG003|Participant Flow|Ipilimumab and Radiotherapy (6 Gy x 3)|
11085166|NCT01497808|OG000|Outcome|Ipilimumab and Radiotherapy (8 Gy x 2)|"Ipilimumab~Stereotactic Body Radiation Therapy"
11085167|NCT01497808|OG001|Outcome|Ipilimumab and Radiotherapy (8 Gy x 3)|
11085168|NCT01497808|OG002|Outcome|Ipilimumab and Radiotherapy (6 Gy x 2)|
11233795|NCT02431260|FG011|Participant Flow|Part 1 / Treatment Group B: 20 MG BID INCB054329|Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
11085169|NCT01497808|OG003|Outcome|Ipilimumab and Radiotherapy (6 Gy x 3)|
11085170|NCT01497808|EG000|Reported Event|Ipilimumab and Radiotherapy (8 Gy x 2)|
11085171|NCT01497808|EG001|Reported Event|Ipilimumab and Radiotherapy (8 Gy x 3)|
11085172|NCT01497808|EG002|Reported Event|Ipilimumab and Radiotherapy (6 Gy x 2)|
11085173|NCT01497808|EG003|Reported Event|Ipilimumab and Radiotherapy (6 Gy x 3)|
11085174|NCT01497860|BG000|Baseline|Vinorelbine|Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months. Patients recruited without incidence over a 2 year period.
11085175|NCT01497860|FG000|Participant Flow|Vinorelbine|Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months.
11085176|NCT01497860|OG000|Outcome|Vinorelbine|"IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.~Vinorelbine: IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months."
11085177|NCT01497860|EG000|Reported Event|Adverse Events|Neutropenia - Grade 4 (n=2) Thrombocytopenia - Grade 4 (n=1) Anemia - Grade 3 (n=2) Weight Loss - grade 2 (n=1)
11085178|NCT01497899|BG000|Baseline|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11085179|NCT01497899|BG001|Baseline|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11085180|NCT01497899|BG002|Baseline|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
11085181|NCT01497899|BG003|Baseline|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
11085182|NCT01497899|BG004|Baseline|Total|Total of all reporting groups
11085183|NCT01497899|FG000|Participant Flow|E/C/F/TAF|"Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11085184|NCT01497899|FG001|Participant Flow|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11233796|NCT02431260|FG012|Participant Flow|Part 2 / Treatment Group A: 20 MG BID INCB054329|Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
11085185|NCT01497899|FG002|Participant Flow|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
11085186|NCT01497899|FG003|Participant Flow|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received darunavir (DRV) + cobicistat (COBI) + Truvada® (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
11085187|NCT01497899|OG000|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11085188|NCT01497899|OG001|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11085189|NCT01497899|EG000|Reported Event|E/C/F/TAF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TAF.~Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks; Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11085190|NCT01497899|EG001|Reported Event|E/C/F/TDF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TDF.~Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks; Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11085191|NCT01497899|EG002|Reported Event|All E/C/F/TAF|"Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.~Participants received blinded or open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
11085192|NCT01497938|BG000|Baseline|Low Glucose Suspend Feature (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study~Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
11085193|NCT01497938|BG001|Baseline|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm~Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
11233797|NCT02431260|FG013|Participant Flow|Part 2 / Treatment Group C: 20 mg BID INCB054329|Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
11085194|NCT01497938|BG002|Baseline|Total|Total of all reporting groups
11085195|NCT01497938|FG000|Participant Flow|Low Glucose Suspend Feasure (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study~Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
11085196|NCT01497938|FG001|Participant Flow|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm~Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
11085197|NCT01497938|OG000|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
11085198|NCT01497938|OG001|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
11085199|NCT01497938|EG000|Reported Event|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
11085200|NCT01497938|EG001|Reported Event|Group B Without Low Glucose Suspend (LGS) Feature|
11085201|NCT01498068|BG000|Baseline|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
11085202|NCT01498068|BG001|Baseline|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
11085203|NCT01498068|BG002|Baseline|Total|Total of all reporting groups
11085204|NCT01498068|FG000|Participant Flow|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
11085205|NCT01498068|FG001|Participant Flow|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
11085206|NCT01498068|OG000|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
11085207|NCT01498068|OG001|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
11085208|NCT01498068|EG000|Reported Event|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
11085209|NCT01498068|EG001|Reported Event|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
11085210|NCT01498120|BG000|Baseline|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
11085211|NCT01498120|FG000|Participant Flow|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
11085212|NCT01498120|OG000|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
11085213|NCT01498120|EG000|Reported Event|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
11085214|NCT01498185|BG000|Baseline|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
11085215|NCT01498185|BG001|Baseline|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085216|NCT01498185|BG002|Baseline|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085217|NCT01498185|BG003|Baseline|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085218|NCT01498185|BG004|Baseline|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085219|NCT01498185|BG005|Baseline|Total|Total of all reporting groups
11085220|NCT01498185|FG000|Participant Flow|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
11227794|NCT02386995|EG000|Reported Event|BIS and Entropy Monitoring|"Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.~BIS monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.~Entropy monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia"
11227795|NCT02387008|BG000|Baseline|GUIDOR® Membrane With FDBA|"Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA~GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA"
11227796|NCT02387008|BG001|Baseline|GUIDOR® Membrane Alone|"Horizontal bone augmentation with synthetic GUIDOR® membrane~GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane"
11085221|NCT01498185|FG001|Participant Flow|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085222|NCT01498185|FG002|Participant Flow|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085223|NCT01498185|FG003|Participant Flow|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085224|NCT01498185|FG004|Participant Flow|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085225|NCT01498185|OG000|Outcome|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
11085226|NCT01498185|OG001|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085227|NCT01498185|OG002|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085228|NCT01498185|OG003|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085229|NCT01498185|OG004|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085230|NCT01498185|OG000|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085231|NCT01498185|OG001|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085232|NCT01498185|OG002|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085233|NCT01498185|OG003|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085234|NCT01498185|EG000|Reported Event|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
11085235|NCT01498185|EG001|Reported Event|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085236|NCT01498185|EG002|Reported Event|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085237|NCT01498185|EG003|Reported Event|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085238|NCT01498185|EG004|Reported Event|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
11085239|NCT01498289|BG000|Baseline|Arm I|"FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.~fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.~leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.~oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle."
11085240|NCT01498289|BG001|Baseline|Arm II|"Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.~irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle."
11085241|NCT01498289|BG002|Baseline|Total|Total of all reporting groups
11085242|NCT01498289|FG000|Participant Flow|Arm I|"FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.~fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.~leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.~oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle."
11085243|NCT01498289|FG001|Participant Flow|Arm II|"IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.~irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle."
11085244|NCT01498289|OG000|Outcome|Arm I FOLFOX|"FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.~fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.~leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.~oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle."
11085245|NCT01498289|OG001|Outcome|Arm II IT|"IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.~irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle."
11085246|NCT01498289|OG000|Outcome|Arm I|"FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.~fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.~leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.~oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle."
11085247|NCT01498289|OG001|Outcome|Arm II|"IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.~irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle."
11227797|NCT02387008|BG002|Baseline|Bio-Gide® Membrane With FDBA|"Xenograft BioGide® membrane + FDBA~Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA"
11085248|NCT01498289|OG000|Outcome|Arm I FOLFOX|FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium.
11085249|NCT01498289|OG001|Outcome|Arm II IT|IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
11085250|NCT01498289|EG000|Reported Event|Arm I FOLFOX|FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium.
11085251|NCT01498289|EG001|Reported Event|Arm II IT|IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
11085252|NCT01498419|BG000|Baseline|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085253|NCT01498419|BG001|Baseline|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085254|NCT01498419|BG002|Baseline|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
11085255|NCT01498419|BG003|Baseline|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085256|NCT01498419|BG004|Baseline|Total|Total of all reporting groups
11085257|NCT01498419|FG000|Participant Flow|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11227798|NCT02387008|BG003|Baseline|Total|Total of all reporting groups
11227799|NCT02387008|FG000|Participant Flow|GUIDOR® Membrane With FDBA|"Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA~GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA"
11085258|NCT01498419|FG001|Participant Flow|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085259|NCT01498419|FG002|Participant Flow|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
11085260|NCT01498419|FG003|Participant Flow|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085261|NCT01498419|OG000|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085262|NCT01498419|OG001|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085263|NCT01498419|OG002|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
11085264|NCT01498419|OG003|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085265|NCT01498419|EG000|Reported Event|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085266|NCT01498419|EG001|Reported Event|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085267|NCT01498419|EG002|Reported Event|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
11085268|NCT01498419|EG003|Reported Event|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
11085269|NCT01498445|BG000|Baseline|Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085270|NCT01498445|BG001|Baseline|Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2|"More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085271|NCT01498445|BG002|Baseline|Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085272|NCT01498445|BG003|Baseline|Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2|"More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085273|NCT01498445|BG004|Baseline|Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085274|NCT01498445|BG005|Baseline|Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2|"More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085275|NCT01498445|BG006|Baseline|Total|Total of all reporting groups
11085276|NCT01498445|FG000|Participant Flow|Phase I Schedule A1|Dasatinib 100mg + Decitabine 10 mg/m2
11085277|NCT01498445|FG001|Participant Flow|Phase I Schedule A2|Dasatinib 100 mg + Decitabine 20 mg/m2
11085278|NCT01498445|FG002|Participant Flow|Phase I Schedule B1|Dasatinib 140 mg + Decitabine 10 mg/m2
11085279|NCT01498445|FG003|Participant Flow|Phase I Schedule B2|Dasatinib 140 mg+ Decitabine 20 mg/m2
11085280|NCT01498445|FG004|Participant Flow|Phase II B1|Dasatinib 140 mg + Decitabine 10 mg/m2
11085281|NCT01498445|FG005|Participant Flow|Phase II B2|Dasatinib 140 mg + Decitabine 20 mg/m2
11085282|NCT01498445|OG000|Outcome|Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085283|NCT01498445|OG001|Outcome|Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2|"More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085284|NCT01498445|OG002|Outcome|Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085285|NCT01498445|OG003|Outcome|Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2|"More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085286|NCT01498445|OG004|Outcome|Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085287|NCT01498445|OG005|Outcome|Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2|"More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085288|NCT01498445|EG000|Reported Event|Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085289|NCT01498445|EG001|Reported Event|Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2|"More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085290|NCT01498445|EG002|Reported Event|Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085291|NCT01498445|EG003|Reported Event|Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2|"More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085292|NCT01498445|EG004|Reported Event|Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2|"Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085293|NCT01498445|EG005|Reported Event|Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2|"More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.~Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.~Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle."
11085294|NCT01498549|BG000|Baseline|Total Sample|This is the summary of the total sample used in the crossover design.
11085295|NCT01498549|FG000|Participant Flow|Participants|Participants were randomly assigned to one of 3 possible groups over a 3 day assessment period.
11085296|NCT01498549|OG000|Outcome|Atomoxetine 40 mg|Atomoxetine 40 mg dose
11085297|NCT01498549|OG001|Outcome|Atomoxetine 80 mg|Atomoxetine 80 mg dose
11085298|NCT01498549|OG002|Outcome|Sugar Pill 0mg|Sugar pill 0mg dose
11085299|NCT01498549|OG002|Outcome|Sugar Pill 0mg|Sugar pill 0 mg dose
11085300|NCT01498549|EG000|Reported Event|Atomoxetine 40 mg|Atomoxetine 40 mg dose
11085301|NCT01498549|EG001|Reported Event|Atomoxetine 80 mg|Atomoxetine 80 mg dose
11085302|NCT01498549|EG002|Reported Event|Sugar Pill 0 mg|Sugar pill 0 mg dose
11085303|NCT01498575|BG000|Baseline|Teen Driving Plan|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
11085304|NCT01498575|BG001|Baseline|Usual Practice|Use of typical supervised practice driving resources
11085305|NCT01498575|BG002|Baseline|Total|Total of all reporting groups
11085306|NCT01498575|FG000|Participant Flow|Teen Driving Plan (TDP)|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
11085307|NCT01498575|FG001|Participant Flow|Usual Practice (Control)|Use of typical supervised practice driving resources
11085308|NCT01498575|OG000|Outcome|Teen Driving Plan (TDP)|Access to web-based driving intervention that provides practice supervisors with specific guidance for facilitating supervision of teens' practice drives across several environments and conditions (eg., highways, commercial districts) using brief instructional videos and resources.
11085309|NCT01498575|OG001|Outcome|Usual Practice (Control)|Participants received a hard copy of the Pennsylvania driver's manual, also available online and at licensing centers.
11085310|NCT01498575|EG000|Reported Event|Teen Driving Plan (TDP)|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
11085311|NCT01498575|EG001|Reported Event|Usual Practice (Control)|Use of typical supervised practice driving resources
11227800|NCT02387008|FG001|Participant Flow|GUIDOR® Membrane Alone|"Horizontal bone augmentation with synthetic GUIDOR® membrane~GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane"
11085312|NCT01498588|BG000|Baseline|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
11085313|NCT01498588|FG000|Participant Flow|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
11085314|NCT01498588|OG000|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
11085315|NCT01498588|EG000|Reported Event|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
11085316|NCT01498601|BG000|Baseline|Oral Care Treatment Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified upon admission to the in-patient unit during the study period.
11085317|NCT01498601|BG001|Baseline|Retrospective Study Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified through a retrospective chart review for the same in-patient unit.
11085318|NCT01498601|BG002|Baseline|Total|Total of all reporting groups
11085319|NCT01498601|FG000|Participant Flow|Retrospective Study Group|A retrospective chart review identified matched in-patients meeting the study inclusion criteria.
11085320|NCT01498601|FG001|Participant Flow|Oral Care Treatment Group|"All subjects in the intervention group received the enhanced oral care protocol:~Changing mouth suction equipment every 24 hours~Mouth assessment every 2-4 hours~Cleansing mouth with toothbrush every 12 hours~Cleansing oral mucosa with oral rinse solution every 2-4 hours~Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours~Suction mouth and throat as needed~Head of the bed elevated to a minimum of 30° during oral care"
11085321|NCT01498601|OG000|Outcome|Oral Care Treatment Group|Acute neurologically impaired adults receiving the study protocol
11085322|NCT01498601|OG001|Outcome|Retrospective Study Group|Acute neurologically impaired adults in the retrospective chart review
11085323|NCT01498601|EG000|Reported Event|Oral Care Treatment Group|Subjects meeting the inclusion criteria and identified at the point of admission to the in-patient unit during the study period.
11085324|NCT01498601|EG001|Reported Event|Retrospective Study Group|Subjects were identified through a chart review process for in-patients on the study unit unit during the retrospective study period and met the inclusion criteria .
11085325|NCT01498640|BG000|Baseline|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
11085326|NCT01498640|FG000|Participant Flow|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
11085327|NCT01498640|OG000|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
11085328|NCT01498640|OG001|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
11085329|NCT01498640|OG000|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
11085330|NCT01498640|OG001|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
11085331|NCT01498640|OG000|Outcome|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
11085332|NCT01498640|EG000|Reported Event|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
11085333|NCT01498653|BG000|Baseline|Fluticasone Furoate/Vilanterol 200/25 µg OD|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
11085334|NCT01498653|BG001|Baseline|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
11085335|NCT01498653|BG002|Baseline|Total|Total of all reporting groups
11085336|NCT01498653|FG000|Participant Flow|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
11085337|NCT01498653|FG001|Participant Flow|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
11085338|NCT01498653|OG000|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
11085339|NCT01498653|OG001|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
11085340|NCT01498653|EG000|Reported Event|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
11085341|NCT01498653|EG001|Reported Event|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
11085342|NCT01498679|BG000|Baseline|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
11085343|NCT01498679|BG001|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
11085344|NCT01498679|BG002|Baseline|Total|Total of all reporting groups
11085345|NCT01498679|FG000|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
11085346|NCT01498679|FG001|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 100/25 micrograms (µg) OD in the evening,via a DPI, for a period of 12 weeks.
11085347|NCT01498679|OG000|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
11085348|NCT01498679|OG001|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
11085349|NCT01498679|EG000|Reported Event|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
11085350|NCT01498679|EG001|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
11085351|NCT01498692|BG000|Baseline|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
11085352|NCT01498692|FG000|Participant Flow|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
11085353|NCT01498692|OG000|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
11085354|NCT01498692|EG000|Reported Event|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
11085355|NCT01498744|BG000|Baseline|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
11085356|NCT01498744|BG001|Baseline|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
11085357|NCT01498744|BG002|Baseline|Total|Total of all reporting groups
11085358|NCT01498744|FG000|Participant Flow|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
11085359|NCT01498744|FG001|Participant Flow|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
11085360|NCT01498744|OG000|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
11085361|NCT01498744|OG001|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
11085362|NCT01498744|EG000|Reported Event|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
11227801|NCT02387008|FG002|Participant Flow|Bio-Gide® Membrane With FDBA|"Xenograft BioGide® membrane + Freeze-dried Bone Allograft (FDBA)~Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA"
11085363|NCT01498744|EG001|Reported Event|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
11085364|NCT01498822|BG000|Baseline|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
11085365|NCT01498822|BG001|Baseline|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
11085366|NCT01498822|BG002|Baseline|Total Title|
11085367|NCT01498822|FG000|Participant Flow|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
11085368|NCT01498822|FG001|Participant Flow|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
11085369|NCT01498822|OG000|Outcome|Per Protocol Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
11085370|NCT01498822|OG001|Outcome|Per Protocol Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
11085371|NCT01498822|OG000|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
11085372|NCT01498822|OG001|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
11085373|NCT01498822|EG000|Reported Event|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
11085374|NCT01498822|EG001|Reported Event|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
11085375|NCT01498887|BG000|Baseline|Naive or de Novo Participants|Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
11085376|NCT01498887|BG001|Baseline|Previously Treated With First-line DMTs Participants|Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
11085377|NCT01498887|BG002|Baseline|Total|Total of all reporting groups
11085378|NCT01498887|FG000|Participant Flow|Naive or de Novo Participants|Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
11085379|NCT01498887|FG001|Participant Flow|Previously Treated With First-line DMTs Participants|Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
11085380|NCT01498887|OG000|Outcome|Naive or de Novo Participants|Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
11085381|NCT01498887|OG001|Outcome|Previously Treated With First-line DMTs Participants|Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
11085382|NCT01498887|EG000|Reported Event|Naive or de Novo Participants|Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
11085383|NCT01498887|EG001|Reported Event|Previously Treated With First-line DMTs Participants|Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
11085384|NCT01498887|EG002|Reported Event|All Participants|
11085385|NCT01498952|BG000|Baseline|Phase 1b Cohort A|Participants received MEDI-573 10 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085386|NCT01498952|BG001|Baseline|Phase 1b Cohort B|Participants received MEDI-573 45 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085387|NCT01498952|BG002|Baseline|Total|Total of all reporting groups
11085388|NCT01498952|FG000|Participant Flow|Phase 1b Cohort A|Participants received MEDI-573 10 mg/kg intravenous infusion (IV) on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085389|NCT01498952|FG001|Participant Flow|Phase 1b Cohort B|Participants received MEDI-573 45 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085390|NCT01498952|FG002|Participant Flow|Phase 1b Cohort C|Participants were planned to receive MEDI-573 30 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085391|NCT01498952|FG003|Participant Flow|Phase 2 Arm 1|Participants were planned to receive recommended dose of MEDI-573 from Phase 1b IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085392|NCT01498952|FG004|Participant Flow|Phase 2 Arm 2|Participants were planned to receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085393|NCT01498952|OG000|Outcome|Phase 1b Cohort A|Participants received MEDI-573 10 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085394|NCT01498952|OG001|Outcome|Phase 1b Cohort B|Participants received MEDI-573 45 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085395|NCT01498952|OG000|Outcome|Phase 2 Arm 1|Participants were planned to receive the recommended dose of MEDI-573 from Phase 1b IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085396|NCT01498952|OG001|Outcome|Phase 2 Arm 2|Participants were planned to receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085397|NCT01498952|OG002|Outcome|Phase 2 Arm 1|Participants were planned to receive the recommended dose of MEDI-573 from Phase 1b IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085398|NCT01498952|OG003|Outcome|Phase 2 Arm 2|Participants were planned to receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons
11085399|NCT01498952|OG001|Outcome|Phase 2 Arm 2|Participants were planned to receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons
11085400|NCT01498952|OG000|Outcome|Phase 2 Arm 1|In Phase 2, participants was planned to receive the recommended dose of MEDI-573 from Phase 1b IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily (Arm 1) or sorafenib 400 mg orally twice daily (Arm 2) until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085401|NCT01498952|OG003|Outcome|Phase 2 Arm 2|Participants were planned to receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085402|NCT01498952|EG000|Reported Event|Phase 1b Cohort A|Participants received MEDI-573 10 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085403|NCT01498952|EG001|Reported Event|Phase 1b Cohort B|Participants received MEDI-573 45 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
11085404|NCT01498978|BG000|Baseline|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
11085405|NCT01498978|FG000|Participant Flow|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
11085406|NCT01498978|OG000|Outcome|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
11085407|NCT01498978|OG000|Outcome|Yes: IRAE|"Patients that experienced an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
11085408|NCT01498978|OG001|Outcome|No: IRAE|"Patients that did not experience an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
11085409|NCT01498978|EG000|Reported Event|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
11085410|NCT01499043|BG000|Baseline|PLX3397|Participants who received a daily oral dose of PLX3397 for 28 day cycles and continued on therapy until disease progression or toxicity.
11085411|NCT01499043|FG000|Participant Flow|PLX3397|Participants who received a daily oral dose of PLX3397 for 28 day cycles and continued on therapy until disease progression or toxicity.
11085412|NCT01499043|OG000|Outcome|PLX3397|Participants who received a daily oral dose of PLX3397 for 28 day cycles and continued on therapy until disease progression or toxicity.
11085413|NCT01499043|OG000|Outcome|NCI CTCAE Grade 1|Participants who received PLX3397 and experienced a Grade 1 treatment-emergent adverse event.
11085414|NCT01499043|OG001|Outcome|NCI CTCAE Grade 2|Participants who received PLX3397 and experienced a Grade 2 treatment-emergent adverse event.
11085415|NCT01499043|OG002|Outcome|NCI CTCAE Grade 3|Participants who received PLX3397 and experienced a Grade 3 treatment-emergent adverse event.
11085416|NCT01499043|OG003|Outcome|NCI CTCAE Grade 4|Participants who received PLX3397 and experienced a Grade 4 treatment-emergent adverse event.
11085417|NCT01499043|OG004|Outcome|NCI CTCAE Grade 5|Participants who received PLX3397 and experienced a Grade 5 treatment-emergent adverse event.
11085418|NCT01499043|EG000|Reported Event|PLX3397|Participants who received a daily oral dose of PLX3397 for 28 day cycles and continued on therapy until disease progression or toxicity.
11085419|NCT01499134|BG000|Baseline|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
11085420|NCT01499134|BG001|Baseline|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
11085421|NCT01499134|BG002|Baseline|Total|Total of all reporting groups
11085422|NCT01499134|FG000|Participant Flow|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
11085423|NCT01499134|FG001|Participant Flow|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
11085424|NCT01499134|OG000|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
11085425|NCT01499134|OG001|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
11085426|NCT01499134|EG000|Reported Event|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
11085427|NCT01499134|EG001|Reported Event|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
11085428|NCT01499147|BG000|Baseline|Arm 1|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
11085429|NCT01499147|BG001|Baseline|Arm 2|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
11085430|NCT01499147|BG002|Baseline|Total|Total of all reporting groups
11085431|NCT01499147|FG000|Participant Flow|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
11085432|NCT01499147|FG001|Participant Flow|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
11085433|NCT01499147|OG000|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
11085434|NCT01499147|OG001|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
11085435|NCT01499147|OG000|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.~ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen."
11085436|NCT01499147|OG001|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).~ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen."
11085437|NCT01499147|OG001|Outcome|Fludarabine/Melphalan +ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
11227802|NCT02387008|OG000|Outcome|GUIDOR® Membrane With FDBA|"Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA~GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA"
11227803|NCT02387008|OG001|Outcome|GUIDOR® Membrane Alone|"Horizontal bone augmentation with synthetic GUIDOR® membrane~GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane"
11085438|NCT01499147|EG000|Reported Event|Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and FluMel and receiving PBSC.
11085439|NCT01499147|EG001|Reported Event|FluBu Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and receiving PBSC.
11085440|NCT01499147|EG002|Reported Event|FluMel Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluMel and receiving PBSC.
11085441|NCT01499173|BG000|Baseline|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
11227804|NCT02387008|OG002|Outcome|Bio-Gide® Membrane With FDBA|"Xenograft BioGide® membrane + FDBA~Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA"
11227805|NCT02387008|EG000|Reported Event|GUIDOR® Membrane With FDBA|"Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA~GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA"
11227806|NCT02387008|EG001|Reported Event|GUIDOR® Membrane Alone|"Horizontal bone augmentation with synthetic GUIDOR® membrane~GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane"
11085442|NCT01499173|FG000|Participant Flow|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
11085443|NCT01499173|OG000|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
11085444|NCT01499173|OG000|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American churches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
11085445|NCT01499173|EG000|Reported Event|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
11085446|NCT01499199|BG000|Baseline|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
11085447|NCT01499199|FG000|Participant Flow|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
11085448|NCT01499199|OG000|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
11085449|NCT01499199|EG000|Reported Event|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
11085450|NCT01499277|BG000|Baseline|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
11227807|NCT02387008|EG002|Reported Event|Bio-Gide® Membrane With FDBA|"Xenograft BioGide® membrane + FDBA~Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA"
11085451|NCT01499277|BG001|Baseline|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
11085452|NCT01499277|BG002|Baseline|Total|Total of all reporting groups
11085453|NCT01499277|FG000|Participant Flow|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
11085454|NCT01499277|FG001|Participant Flow|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
11085455|NCT01499277|OG000|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
11085456|NCT01499277|OG001|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
11085457|NCT01499277|EG000|Reported Event|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
11085458|NCT01499277|EG001|Reported Event|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
11085459|NCT01499290|BG000|Baseline|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
11085460|NCT01499290|BG001|Baseline|Meropenem|1000 mg: IV treatment
11227808|NCT02387164|BG000|Baseline|Alum-GAD, Vitamin D3|"Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.~Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated~Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily"
11085461|NCT01499290|BG002|Baseline|Total|Total of all reporting groups
11085462|NCT01499290|FG000|Participant Flow|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
11085463|NCT01499290|FG001|Participant Flow|Meropenem|1000 mg: IV treatment
11085464|NCT01499290|OG000|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
11085465|NCT01499290|OG001|Outcome|Meropenem|1000 mg: IV treatment
11085466|NCT01499290|OG000|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours of last dose of study drug
11085467|NCT01499290|OG001|Outcome|Meropenem (EOT)|EOT - within 24 hours of last dose of study drug
11085468|NCT01499290|OG002|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
11085469|NCT01499290|OG003|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
11085470|NCT01499290|OG004|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
11085471|NCT01499290|OG005|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
11085472|NCT01499290|OG000|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours after last dose of study drug
11085473|NCT01499290|OG001|Outcome|Meropenem (EOT)|EOT - within 24 hours after last dose of study drug
11085474|NCT01499290|OG000|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment Number of favourable responses
11085475|NCT01499290|OG001|Outcome|Meropenem|1000 mg: IV treatment. Number of favourable responses
11085476|NCT01499290|OG002|Outcome|CAZ-AVI + Metronidazole (Denominator)|Total number of patiets with each pathogen at baseline (summary only shows pathogens where N>/=10)
11085477|NCT01499290|OG003|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
11085478|NCT01499290|OG002|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
11085479|NCT01499290|OG000|Outcome|CAZ (1)|30 mins before/after dose
11085480|NCT01499290|OG001|Outcome|AVI (1)|30 min before/after dose
11085481|NCT01499290|OG002|Outcome|CAZ (2)|30-90 mins after dose
11085482|NCT01499290|OG003|Outcome|AVI (2)|30-90 mins after dose
11085483|NCT01499290|OG004|Outcome|CAZ (3)|300-360 mins after dose
11085484|NCT01499290|OG005|Outcome|AVI (3)|300-360 mins after dose
11085485|NCT01499290|EG000|Reported Event|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment.
11085486|NCT01499290|EG001|Reported Event|Meropenem|1000 mg: IV treatment
11085487|NCT01499303|BG000|Baseline|100mg BID|100mg Fostmatinib BID
11085488|NCT01499303|BG001|Baseline|200mg BID|200mg Fostmatinib BID
11085489|NCT01499303|BG002|Baseline|Total|Total of all reporting groups
11085490|NCT01499303|FG000|Participant Flow|100mg BID|100mg Fostmatinib BID
11085491|NCT01499303|FG001|Participant Flow|200mg BID|200mg Fostmatinib BID
11085492|NCT01499303|OG000|Outcome|100mg BID|100mg Fostmatinib BID
11085493|NCT01499303|OG001|Outcome|200mg BID|200mg Fostmatinib BID
11085494|NCT01499303|EG000|Reported Event|100mg BID|100mg Fostmatinib BID
11085495|NCT01499303|EG001|Reported Event|200mg BID|200mg Fostmatinib BID
11085496|NCT01499355|BG000|Baseline|All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
11085497|NCT01499355|FG000|Participant Flow|Run-In Period: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received mycophenolate mofetil (MMF) starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
11085498|NCT01499355|FG001|Participant Flow|Double-Blind Period: Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
11085499|NCT01499355|FG002|Participant Flow|Double-Blind Period: BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
11085500|NCT01499355|FG003|Participant Flow|Double-Blind Period: BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
11085501|NCT01499355|OG000|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
11227809|NCT02387164|BG001|Baseline|Placebo, Vitamin D3|"Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years~Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily"
11085502|NCT01499355|OG001|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
11085503|NCT01499355|OG002|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
11085504|NCT01499355|OG000|Outcome|Run-In: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
11085505|NCT01499355|EG000|Reported Event|Run-in Period|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
11085506|NCT01499355|EG001|Reported Event|Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
11085507|NCT01499355|EG002|Reported Event|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
11085508|NCT01499355|EG003|Reported Event|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
11085509|NCT01499368|BG000|Baseline|Lafutidine|"Lafutidine 20mg/day~Lafutidine: Lafutidine 20mg/day"
11085510|NCT01499368|BG001|Baseline|Famotidine|"Famotidine 40mg/day~Famotidine: Famotidine 40mg/day"
11085511|NCT01499368|BG002|Baseline|Omeprazole|"Omeprazole 20mg/day~Omeprazole: Omeprazole 20mg/day"
11085512|NCT01499368|BG003|Baseline|Total|Total of all reporting groups
10851385|NCT00306202|FG001|Participant Flow|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
11085513|NCT01499368|FG000|Participant Flow|Lafutidine|"Lafutidine 20mg/day~Lafutidine 10mg bid, po"
11085514|NCT01499368|FG001|Participant Flow|Famotidine|"Famotidine 40mg/day~Famotidine 20mg bid, po"
11085515|NCT01499368|FG002|Participant Flow|Omeprazole|"Omeprazole 20mg/day~Omeprazole 20mg qd(daily), po"
11085516|NCT01499368|OG000|Outcome|Lafutidine|"Lafutidine 20mg/day~Lafutidine 10mg bid, po"
11085517|NCT01499368|OG001|Outcome|Famotidine|"Famotidine 40mg/day~Famotidine 20mg bid, po"
11085518|NCT01499368|OG002|Outcome|Omeprazole|"Omeprazole 20mg/day~Omeprazole 20mg qd(daily), po"
11085519|NCT01499368|EG000|Reported Event|Lafutidine|"Lafutidine 20mg/day~Lafutidine 10mg bid, po"
11085520|NCT01499368|EG001|Reported Event|Famotidine|"Famotidine 40mg/day~Famotidine 20mg bid, po"
11085521|NCT01499368|EG002|Reported Event|Omeprazole|"Omeprazole 20mg/day~Omeprazole 20mg qd(daily), po"
11227810|NCT02387164|BG002|Baseline|Total|Total of all reporting groups
11085522|NCT01499498|BG000|Baseline|Sildenafil and Boceprevir|All subjects take single dose sildenafil 25mg day 0, day 10-15 they take boceprevir 800mg three times a day followed by Intentive PK on day 15 and on day 16 single dose of sildenafil and boceprevir together followed by intensive PK
11085523|NCT01499498|FG000|Participant Flow|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
11085524|NCT01499498|OG000|Outcome|Sildenafil Only|"Healthy volunteers~Sildenafil 25mg once"
11085525|NCT01499498|OG000|Outcome|Bocepreprivir Alone|"Healthy volunteers~Boceprevir: 800mg three times a day"
10887664|NCT00502242|BG000|Baseline|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center's standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
10887665|NCT00502242|BG001|Baseline|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center's standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
10887666|NCT00502242|BG002|Baseline|Total|Total of all reporting groups
11085526|NCT01499498|OG000|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir: 25mg once/800mg three times a day"
11085527|NCT01499498|OG000|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
11227811|NCT02387164|FG000|Participant Flow|Alum-GAD, Vitamin D3|"Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.~Alum-GAD (Glutamic Acid Decarboxylase): Two doses à 20 microgram 30 days apart subcutaneously administrated~Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily"
11085528|NCT01499498|EG000|Reported Event|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
11085529|NCT01499511|BG000|Baseline|ASCOT Participants Amlodipine|It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.
11085530|NCT01499511|BG001|Baseline|ASCOT Participants Atenolol|It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
11085531|NCT01499511|BG002|Baseline|Total|Total of all reporting groups
11085532|NCT01499511|FG000|Participant Flow|ASCOT Participants Amlodipine|It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.
11085533|NCT01499511|FG001|Participant Flow|ASCOT Participants Atenolol|It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
11085534|NCT01499511|OG000|Outcome|ASCOT Participants|Participants from the ASCOT study recruited to the participating ASCOT study centres in the United Kingdom.
11085535|NCT01499511|OG000|Outcome|ASCOT Participants Amlodipine|It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.
11085536|NCT01499511|OG001|Outcome|ASCOT Participants Atenolol|It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
11085537|NCT01499511|EG000|Reported Event|ASCOT Participants Amlodipine|Follow up study for amlodipine, no intervention.
11085538|NCT01499511|EG001|Reported Event|ASCOT Participants Atenolol|Follow up study for atenolol, no intervention.
11085539|NCT01499576|BG000|Baseline|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
11085540|NCT01499576|FG000|Participant Flow|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
11085541|NCT01499576|OG000|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
11085542|NCT01499576|OG000|Outcome|Acetic Acid Spraying|The same participants primary outcome analysed
11085543|NCT01499576|EG000|Reported Event|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
11085544|NCT01499654|BG000|Baseline|Study Group|Entire cohort
11085545|NCT01499654|FG000|Participant Flow|Study Group|Entire cohort
11085546|NCT01499654|OG000|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
11085547|NCT01499654|OG001|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
11085548|NCT01499654|OG002|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
11085549|NCT01499654|OG000|Outcome|Study Group|Entire cohort
11085550|NCT01499654|OG000|Outcome|Injection 1 to Scan 1|Time in minutes between the first 1/2 dose injection and the first scan
11085551|NCT01499654|OG001|Outcome|Injection 2 to Scan 2|Time in minutes between the second 1/2 dose injection and the second scan.
11085552|NCT01499654|OG002|Outcome|Injection 1 to Injection 2|Time in minutes between the first 1/2 dose injection and the second 1/2 dose injection
11085553|NCT01499654|EG000|Reported Event|Study Group|Entire cohort for the study
11085554|NCT01499667|BG000|Baseline|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
11085555|NCT01499667|BG001|Baseline|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
11085556|NCT01499667|BG002|Baseline|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod
11227812|NCT02387164|FG001|Participant Flow|Placebo, Vitamin D3|"Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years~Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily"
11227813|NCT02387164|OG000|Outcome|Alum-GAD, Vitamin D3|"Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.~Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated~Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily"
11085557|NCT01499667|BG003|Baseline|Total|Total of all reporting groups
11085558|NCT01499667|FG000|Participant Flow|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
11085559|NCT01499667|FG001|Participant Flow|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
11085560|NCT01499667|FG002|Participant Flow|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
11085561|NCT01499667|OG000|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
11085562|NCT01499667|OG001|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
11085563|NCT01499667|OG002|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
11085564|NCT01499667|EG000|Reported Event|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
11085565|NCT01499667|EG001|Reported Event|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
11085566|NCT01499667|EG002|Reported Event|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
11085567|NCT01499810|BG000|Baseline|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
11085568|NCT01499810|FG000|Participant Flow|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
11085569|NCT01499810|OG000|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
11085570|NCT01499810|OG000|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
11227814|NCT02387164|OG001|Outcome|Placebo, Vitamin D3|"Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years~Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily"
11227815|NCT02387164|EG000|Reported Event|Alum-GAD, Vitamin D3|"Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.~Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated~Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily"
11085571|NCT01499810|EG000|Reported Event|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
11085572|NCT01499849|BG000|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085573|NCT01499849|BG001|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085574|NCT01499849|BG002|Baseline|Total|Total of all reporting groups
11085575|NCT01499849|FG000|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085576|NCT01499849|FG001|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085577|NCT01499849|OG000|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085578|NCT01499849|OG001|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085579|NCT01499849|EG000|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085580|NCT01499849|EG001|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085581|NCT01499862|BG000|Baseline|All Participants|All subjects had reached plateau with conventional Bodyweight-Supported Treadmill Training (BWSTT, participated in task-oriented mobility therapy(1.5 hours, 2-4 times per week for 4 weeks) with Robotic Leg Orthosis (RLO) under the supervision of a physical therapist.
11085582|NCT01499862|FG000|Participant Flow|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
11085583|NCT01499862|OG000|Outcome|Patient 1|Six Minute Walk Test (meters)
11085584|NCT01499862|OG001|Outcome|Patient 2|Six Minute Walk Test (meters)
11085585|NCT01499862|OG002|Outcome|Patient 3|Six Minute Walk Test (meters)
11085586|NCT01499862|OG000|Outcome|Patient 1|Timed Up and Go Test (seconds)
10851386|NCT00306202|FG002|Participant Flow|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
11085587|NCT01499862|OG001|Outcome|Patient 2|Timed Up and Go Test (seconds)
11085588|NCT01499862|OG002|Outcome|Patient 3|Timed Up and Go Test (seconds)
11085589|NCT01499862|OG000|Outcome|Patient 1|Five Times Sit to Stand Test (seconds)
11085590|NCT01499862|OG001|Outcome|Patient 2|Five Times Sit to Stand Test (seconds)
11085591|NCT01499862|OG002|Outcome|Patient 3|Five Times Sit to Stand Test (seconds)
11085592|NCT01499862|OG000|Outcome|Patient 1|Step Length (meters)
11085593|NCT01499862|OG001|Outcome|Patient 2|Step Length (meters)
11085594|NCT01499862|OG002|Outcome|Patient 3|Step Length (meters)
11085595|NCT01499862|OG000|Outcome|Patient 1|Ambulation speed (meters/second)
11085596|NCT01499862|OG001|Outcome|Patient 2|Ambulation speed (meters/second)
11085597|NCT01499862|OG002|Outcome|Patient 3|Ambulation speed (meters/second)
11085598|NCT01499862|EG000|Reported Event|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
11085599|NCT01499940|BG000|Baseline|Vitamin D3 2000 IU/Day|"Vitamin D3 2000 IU/day on day of 1st cycle of oxaliplatin; continue as long as patient treated with oxaliplatin and remains on study~Vitamin D3: Vitamin D3 will be administered at a dose of 2000 IU orally daily starting on day 1 of the first cycle of oxaliplatin. The vitamin will be continued at this dose and schedule for approximately 6 months if the patient is receiving oxaliplatin in the adjuvant setting and neither dosage nor interval has been modified for neurological toxicity. The duration of therapy if oxaliplatin is given for metastatic disease will vary. Nonetheless, the study vitamin will be continued using the same criteria as in the adjuvant setting."
11227816|NCT02387164|EG001|Reported Event|Placebo, Vitamin D3|"Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years~Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily"
11085600|NCT01499940|FG000|Participant Flow|Vitamin D3 2000 IU/Day|"Vitamin D3 2000 IU/day on day of 1st cycle of oxaliplatin; continue as long as patient treated with oxaliplatin and remains on study~Vitamin D3: Vitamin D3 will be administered at a dose of 2000 IU orally daily starting on day 1 of the first cycle of oxaliplatin. The vitamin will be continued at this dose and schedule for approximately 6 months if the patient is receiving oxaliplatin in the adjuvant setting and neither dosage nor interval has been modified for neurological toxicity. The duration of therapy if oxaliplatin is given for metastatic disease will vary. Nonetheless, the study vitamin will be continued using the same criteria as in the adjuvant setting."
11085601|NCT01499940|OG000|Outcome|Vitamin D3 2000 IU/Day|"Vitamin D3 2000 IU/day on day of 1st cycle of oxaliplatin; continue as long as patient treated with oxaliplatin and remains on study~Vitamin D3: Vitamin D3 will be administered at a dose of 2000 IU orally daily starting on day 1 of the first cycle of oxaliplatin. The vitamin will be continued at this dose and schedule for approximately 6 months if the patient is receiving oxaliplatin in the adjuvant setting and neither dosage nor interval has been modified for neurological toxicity. The duration of therapy if oxaliplatin is given for metastatic disease will vary. Nonetheless, the study vitamin will be continued using the same criteria as in the adjuvant setting."
11085602|NCT01499940|EG000|Reported Event|Vitamin D3 2000 IU/Day|"Vitamin D3 2000 IU/day on day of 1st cycle of oxaliplatin; continue as long as patient treated with oxaliplatin and remains on study~Vitamin D3: Vitamin D3 will be administered at a dose of 2000 IU orally daily starting on day 1 of the first cycle of oxaliplatin. The vitamin will be continued at this dose and schedule for approximately 6 months if the patient is receiving oxaliplatin in the adjuvant setting and neither dosage nor interval has been modified for neurological toxicity. The duration of therapy if oxaliplatin is given for metastatic disease will vary. Nonetheless, the study vitamin will be continued using the same criteria as in the adjuvant setting."
11085603|NCT01500031|BG000|Baseline|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
11085604|NCT01500031|FG000|Participant Flow|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
11085605|NCT01500031|OG000|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
11085606|NCT01500031|EG000|Reported Event|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
11085607|NCT01500057|BG000|Baseline|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
11085608|NCT01500057|BG001|Baseline|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
11085609|NCT01500057|BG002|Baseline|Total|Total of all reporting groups
11085610|NCT01500057|FG000|Participant Flow|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
11085611|NCT01500057|FG001|Participant Flow|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
11085612|NCT01500057|OG000|Outcome|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
11085613|NCT01500057|OG001|Outcome|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
11085614|NCT01500057|EG000|Reported Event|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
11085615|NCT01500057|EG001|Reported Event|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
11085616|NCT01500083|BG000|Baseline|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
11085617|NCT01500083|BG001|Baseline|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
11227817|NCT02387216|BG000|Baseline|Arm A (Experimental): MM-121 in Combination With Docetaxel|"MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle~Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle"
11085618|NCT01500083|BG002|Baseline|Total|Total of all reporting groups
11085619|NCT01500083|FG000|Participant Flow|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
11085620|NCT01500083|FG001|Participant Flow|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
11085621|NCT01500083|OG000|Outcome|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
11085622|NCT01500083|OG001|Outcome|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
11085623|NCT01500083|EG000|Reported Event|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
11085624|NCT01500083|EG001|Reported Event|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
11085625|NCT01500096|BG000|Baseline|American Ginseng 1000 mg/Day|"4-week of American ginseng 1000 mg/day every morning~American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks."
11085626|NCT01500096|BG001|Baseline|Placebo for American Ginseng 1000 mg/Day|"4-week of placebo for American ginseng 1000 mg/day every morning~Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
11085627|NCT01500096|BG002|Baseline|American Ginseng 3000 mg/Day|"4-week of American ginseng 3000 mg/day every morning~American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks."
11085628|NCT01500096|BG003|Baseline|Placebo for American Ginseng 3000 mg/Day|"4-week of placebo for American ginseng 3000 mg/day every morning~Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
11085629|NCT01500096|BG004|Baseline|Total|Total of all reporting groups
11085630|NCT01500096|FG000|Participant Flow|American Ginseng 1000 mg/Day|"4-week of American ginseng 1000 mg/day every morning~American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks."
11085631|NCT01500096|FG001|Participant Flow|Placebo for American Ginseng 1000 mg/Day|"4-week of placebo for American ginseng 1000 mg/day every morning~Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
11085632|NCT01500096|FG002|Participant Flow|American Ginseng 3000 mg/Day|"4-week of American ginseng 3000 mg/day every morning~American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks."
11085633|NCT01500096|FG003|Participant Flow|Placebo for American Ginseng 3000 mg/Day|"4-week of placebo for American ginseng 3000 mg/day every morning~Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
11085634|NCT01500096|OG000|Outcome|American Ginseng 1000 mg/Day|"4-week of American ginseng 1000 mg/day every morning~American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks."
11085635|NCT01500096|OG001|Outcome|Placebo for American Ginseng 1000 mg/Day|"4-week of placebo for American ginseng 1000 mg/day every morning~Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
11085636|NCT01500096|OG002|Outcome|American Ginseng 3000 mg/Day|"4-week of American ginseng 3000 mg/day every morning~American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks."
11085637|NCT01500096|OG003|Outcome|Placebo for American Ginseng 3000 mg/Day|"4-week of placebo for American ginseng 3000 mg/day every morning~Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
11085638|NCT01500096|EG000|Reported Event|American Ginseng 1000 mg/Day|"4-week of American ginseng 1000 mg/day every morning~American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks."
11085639|NCT01500096|EG001|Reported Event|Placebo for American Ginseng 1000 mg/Day|"4-week of placebo for American ginseng 1000 mg/day every morning~Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
11085640|NCT01500096|EG002|Reported Event|American Ginseng 3000 mg/Day|"4-week of American ginseng 3000 mg/day every morning~American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks."
11085641|NCT01500096|EG003|Reported Event|Placebo for American Ginseng 3000 mg/Day|"4-week of placebo for American ginseng 3000 mg/day every morning~Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
11085642|NCT01500135|BG000|Baseline|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11227818|NCT02387216|BG001|Baseline|Arm B (Comparator): Docetaxel Alone|"Docetaxel (approved chemotherapy treatment for NSCLC):~75 mg/m˄2 IV on Day 1 of each 21-day cycle"
11227819|NCT02387216|BG002|Baseline|Total|Total of all reporting groups
11085643|NCT01500135|BG001|Baseline|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11085644|NCT01500135|BG002|Baseline|Total|Total of all reporting groups
11085645|NCT01500135|FG000|Participant Flow|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11085646|NCT01500135|FG001|Participant Flow|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11085647|NCT01500135|OG000|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11085648|NCT01500135|OG001|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11085649|NCT01500135|EG000|Reported Event|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11085650|NCT01500135|EG001|Reported Event|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
11085651|NCT01500187|BG000|Baseline|Pediagel|1.23% Acidulated Phosphate Fluoride Gel
11085652|NCT01500187|BG001|Baseline|Vanish Varnish|5% sodium fluoride varnish with tricalcium phosphate
11085653|NCT01500187|BG002|Baseline|Total|Total of all reporting groups
11085654|NCT01500187|FG000|Participant Flow|Pediagel|1.23% Acidulated Phosphate Fluoride Gel (Preventech)
11085655|NCT01500187|FG001|Participant Flow|Vanish Varnish|5% sodium fluoride varnish with tricalcium phosphate (3M)
11085656|NCT01500187|OG000|Outcome|Pediagel|1.23% Acidulated phosphate fluoride
11085657|NCT01500187|OG001|Outcome|Vanish Varnish|5% sodium fluoride varnish with tricalcium phosphate
11085658|NCT01500187|EG000|Reported Event|Group 2|"Oral B Minute-Gel, fluoride gel~Oral B Minute-Gel: Fluoride gel"
11085659|NCT01500187|EG001|Reported Event|Group 1|"Vanish varnish, 5% sodium fluoride varnish with tricalcium phosphate~Vanish varnish: 5% sodium fluoride varnish with tricalcium phosphate"
11085660|NCT01500200|BG000|Baseline|Placebo S1|Received placebo in Stage 1
11085661|NCT01500200|BG001|Baseline|ALKS 5461 2mg/2mg S1|Received ALKS 5461 2mg/2mg in Stage 1
11085662|NCT01500200|BG002|Baseline|ALKS 5461 8mg/8mg S1|Received ALKS 5461 8mg/8mg in Stage 1
11085663|NCT01500200|BG003|Baseline|Total|Total of all reporting groups
11085664|NCT01500200|FG000|Participant Flow|Placebo S1|Received placebo in Stage 1
11085665|NCT01500200|FG001|Participant Flow|ALKS 5461 2mg/2mg S1|Received ALKS 5461 2mg/2mg in Stage 1
11085666|NCT01500200|FG002|Participant Flow|ALKS 5461 8mg/8mg S1|Received ALKS 5461 8mg/8mg in Stage 1
11085667|NCT01500200|FG003|Participant Flow|Placebo S2|Received placebo in Stage 2
11085668|NCT01500200|FG004|Participant Flow|ALKS 5461 2mg/2mg S2|Received ALKS 5461 2mg/2mg in Stage 2
11085669|NCT01500200|FG005|Participant Flow|ALKS 5461 8mg/8mg S2|Received ALKS 5461 8mg/8mg in Stage 2
11085670|NCT01500200|OG000|Outcome|Placebo S1|Subjects randomized to placebo in Stage 1
11085671|NCT01500200|OG001|Outcome|ALKS 5461 2mg/2mg S1|Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
11085672|NCT01500200|OG002|Outcome|ALKS 5461 8mg/8mg S1|Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
11085673|NCT01500200|OG003|Outcome|Placebo S2|Subjects randomized to placebo in Stage 2
11233798|NCT02431260|OG000|Outcome|Part 1 / Treatment Group A: 15 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11085674|NCT01500200|OG004|Outcome|ALKS 5461 2mg/2mg S2|Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
11085675|NCT01500200|OG005|Outcome|ALKS 5461 8mg/8mg S2|Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
11085676|NCT01500200|EG000|Reported Event|Placebo S1|Received placebo in Stage 1
11085677|NCT01500200|EG001|Reported Event|ALKS 5461 2mg/2mg S1|Received ALKS 5461 2mg/2mg in Stage 1
11085678|NCT01500200|EG002|Reported Event|ALKS 5461 8mg/8mg S1|Received ALKS 5461 8mg/8mg in Stage 1
11085679|NCT01500200|EG003|Reported Event|Placebo S2|Received placebo in Stage 2
11085680|NCT01500200|EG004|Reported Event|ALKS 5461 2mg/2mg S2|Received ALKS 5461 2mg/2mg in Stage 1
11085681|NCT01500200|EG005|Reported Event|ALKS 5461 8mg/8mg S2|Received ALKS 5461 8mg/8mg in Stage 1
11085682|NCT01500213|BG000|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085683|NCT01500213|BG001|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085684|NCT01500213|BG002|Baseline|Total|Total of all reporting groups
11085685|NCT01500213|FG000|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085686|NCT01500213|FG001|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085687|NCT01500213|OG000|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085688|NCT01500213|OG001|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4"
11085689|NCT01500213|EG000|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4~278 subjects were randomized to Rolapitant~272 of those randomized to Rolapitant received Rolapitant in C1~Safety = 272 Rolapitant"
11085690|NCT01500213|EG001|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4~277 subjects were randomized to control;~274 of those who were randomized to control received control in C1.~Safety = 274 control"
11085691|NCT01500226|BG000|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
11085692|NCT01500226|BG001|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
11085693|NCT01500226|BG002|Baseline|Total|Total of all reporting groups
11085694|NCT01500226|FG000|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy.~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~Dexamethasone (20 mg orally) about 30 min before chemotherapy."
11085695|NCT01500226|FG001|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
11085696|NCT01500226|OG000|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
11233799|NCT02431260|OG001|Outcome|Part 1 / Treatment Group A: 22.5 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11085697|NCT01500226|OG001|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
11085698|NCT01500226|EG000|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~Dexamethasone (20 mg orally) about 30 min before chemotherapy~684 subjects were randomized to Rolapitant~670 of those randomized to Rolapitant received rolapitant in C1~Safety = 670 Rolapitant"
11085699|NCT01500226|EG001|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1-2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~Dexamethasone (20 mg orally) about 30 min before chemotherapy~685 subjects were randomized to control~674 of those who were randomized to control received control in C1~Safety = 674 control"
11085700|NCT01500252|BG000|Baseline|Patellar Resurfacing|Subjects received patellar resurfacing.
11085701|NCT01500252|BG001|Baseline|Patellar Retention|Subjects retained their native patella.
11085702|NCT01500252|BG002|Baseline|Total|Total of all reporting groups
11085703|NCT01500252|FG000|Participant Flow|Patellar Resurfacing|Subjects received patellar resurfacing.
11085704|NCT01500252|FG001|Participant Flow|Patellar Retention|Subjects retained their native patella.
11085705|NCT01500252|OG000|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
11085706|NCT01500252|OG001|Outcome|Patellar Retention|Subjects retained their native patella.
11085707|NCT01500252|OG000|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing
11085708|NCT01500252|EG000|Reported Event|Patellar Resurfacing|Subjects received patellar resurfacing.
11085709|NCT01500252|EG001|Reported Event|Patellar Retention|Subjects retained their native patella.
11085710|NCT01500278|BG000|Baseline|CZP+MTX (RTG)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
11085711|NCT01500278|BG001|Baseline|ADA+MTX (RTG)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
11085712|NCT01500278|BG002|Baseline|Total Title|
11085713|NCT01500278|FG000|Participant Flow|CZP+MTX (RTG)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
11085714|NCT01500278|FG001|Participant Flow|ADA+MTX (RTG)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
11085715|NCT01500278|OG000|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
11085716|NCT01500278|OG001|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
11085717|NCT01500278|OG000|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
11085718|NCT01500278|OG001|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
11085719|NCT01500278|EG000|Reported Event|CZP+MTX (SS)|All subjects who received at least 1 dose of Certolizumab pegol (CZP). All adverse events that occurred when the subject was receiving CZP treatment are summarized in this group.
11085720|NCT01500278|EG001|Reported Event|ADA+MTX (SS)|All subjects who received at least 1 dose of Adalimumab (ADA). All adverse events that occurred when the subject was receiving ADA treatment are summarized in this group.
11085721|NCT01500317|BG000|Baseline|Tapentadol|75 mg tapentadol tid
11085722|NCT01500317|BG001|Baseline|Oxycodone|5 mg oxycodone tid
11085723|NCT01500317|BG002|Baseline|Placebo|Placebo tid
11085724|NCT01500317|BG003|Baseline|Total|Total of all reporting groups
11085725|NCT01500317|FG000|Participant Flow|Tapentadol|75 mg tapentadol tid
11085726|NCT01500317|FG001|Participant Flow|Oxycodone|5 mg oxycodone tid
11085727|NCT01500317|FG002|Participant Flow|Placebo|Placebo tid
11085728|NCT01500317|OG000|Outcome|Tapentadol|75 mg tapentadol tid
11085729|NCT01500317|OG001|Outcome|Oxycodone|5 mg oxycodone tid
11085730|NCT01500317|OG002|Outcome|Placebo|Placebo tid
11085731|NCT01500317|EG000|Reported Event|Tapentadol|75 mg tapentadol tid
11085732|NCT01500317|EG001|Reported Event|Oxycodone|5 mg oxycodone tid
11085733|NCT01500317|EG002|Reported Event|Placebo|Placebo tid
11085734|NCT01500382|BG000|Baseline|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
11085735|NCT01500382|BG001|Baseline|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
11233800|NCT02431260|OG002|Outcome|Part 1 / Treatment Group A: 15 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11233801|NCT02431260|OG003|Outcome|Part 1 / Treatment Group A: 30 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11085736|NCT01500382|BG002|Baseline|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
11085737|NCT01500382|BG003|Baseline|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
11085738|NCT01500382|BG004|Baseline|Total|Total of all reporting groups
11085739|NCT01500382|FG000|Participant Flow|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
11085740|NCT01500382|FG001|Participant Flow|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
11085741|NCT01500382|FG002|Participant Flow|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
11085742|NCT01500382|FG003|Participant Flow|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
11085743|NCT01500382|OG000|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
11085744|NCT01500382|OG001|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
11085745|NCT01500382|OG002|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
11085746|NCT01500382|OG003|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
11085747|NCT01500382|EG000|Reported Event|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
11085748|NCT01500382|EG001|Reported Event|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
11085749|NCT01500382|EG002|Reported Event|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
11085750|NCT01500382|EG003|Reported Event|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
11085751|NCT01500434|BG000|Baseline|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
11085752|NCT01500434|FG000|Participant Flow|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
11085753|NCT01500434|OG000|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
11085754|NCT01500434|EG000|Reported Event|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
11085755|NCT01500525|BG000|Baseline|Asthmatic Children|children diagnosed by a specialist as asthmatic patients
11085756|NCT01500525|BG001|Baseline|Non-asthmatic Children|children who are healthy and who do not have respiratory syndrom
11085757|NCT01500525|BG002|Baseline|Total|Total of all reporting groups
11085758|NCT01500525|FG000|Participant Flow|Asthmatic Children|children diagnosed by a specialist as asthmatic patients
11085759|NCT01500525|FG001|Participant Flow|Non-asthmatic Children|children who are healthy and who do not have respiratory syndrom
11085760|NCT01500525|OG000|Outcome|Asthmatic Children|children diagnosed by a specialist as asthmatic patients
11085761|NCT01500525|OG001|Outcome|Non-asthmatic Children|children who are healthy and who do not have respiratory syndrom
11085762|NCT01500525|EG000|Reported Event|Asthmatic Children|children diagnosed by a specialist as asthmatic patients
11085763|NCT01500525|EG001|Reported Event|Non-asthmatic Children|children who are healthy and who do not have respiratory syndrom
11085764|NCT01500629|BG000|Baseline|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085765|NCT01500629|BG001|Baseline|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085766|NCT01500629|BG002|Baseline|Total|Total of all reporting groups
11085767|NCT01500629|FG000|Participant Flow|C-1266-7 Then Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
11085768|NCT01500629|FG001|Participant Flow|Placebo Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
11085769|NCT01500629|OG000|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
11085770|NCT01500629|OG001|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
11085771|NCT01500629|OG001|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6, (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
11085772|NCT01500629|OG001|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo).. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo).: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
11085773|NCT01500629|OG000|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085774|NCT01500629|OG001|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085775|NCT01500629|OG001|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085776|NCT01500629|OG000|Outcome|C-1266-7 Then C-1266-6|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085777|NCT01500629|OG001|Outcome|C-1266-6 Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085778|NCT01500629|EG000|Reported Event|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085779|NCT01500629|EG001|Reported Event|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
11085780|NCT01500694|BG000|Baseline|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
11085781|NCT01500694|BG001|Baseline|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
11085782|NCT01500694|BG002|Baseline|Total|Total of all reporting groups
11085783|NCT01500694|FG000|Participant Flow|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 milligram [mg] or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
11085784|NCT01500694|FG001|Participant Flow|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
11085785|NCT01500694|OG000|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
11085786|NCT01500694|OG001|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
11085787|NCT01500694|EG000|Reported Event|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
11085788|NCT01500694|EG001|Reported Event|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
11085789|NCT01500720|BG000|Baseline|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
11085790|NCT01500720|BG001|Baseline|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
11085791|NCT01500720|BG002|Baseline|Total|Total of all reporting groups
11085792|NCT01500720|FG000|Participant Flow|Cabazitaxel|Cabazitaxel (XRP6258) 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
11085793|NCT01500720|FG001|Participant Flow|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
11085794|NCT01500720|OG000|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
11085795|NCT01500720|OG001|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
11085796|NCT01500720|EG000|Reported Event|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
11085797|NCT01500720|EG001|Reported Event|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
11085798|NCT01500746|BG000|Baseline|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.~Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
11085799|NCT01500746|BG001|Baseline|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.~Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
11085800|NCT01500746|BG002|Baseline|Total|Total of all reporting groups
11085801|NCT01500746|FG000|Participant Flow|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
11085802|NCT01500746|FG001|Participant Flow|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
11085803|NCT01500746|OG000|Outcome|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
11085804|NCT01500746|OG001|Outcome|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
11085805|NCT01500746|EG000|Reported Event|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.~Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
11085806|NCT01500746|EG001|Reported Event|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.~Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
11085807|NCT01500759|BG000|Baseline|Chronic HF Without SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11085808|NCT01500759|BG001|Baseline|Chronic HF With SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11085809|NCT01500759|BG002|Baseline|Total|Total of all reporting groups
11085810|NCT01500759|FG000|Participant Flow|Chronic HF Without SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11227820|NCT02387216|FG000|Participant Flow|Arm A (Experimental): MM-121 in Combination With Docetaxel|"MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle~Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle"
11085811|NCT01500759|FG001|Participant Flow|Chronic HF With SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11227821|NCT02387216|FG001|Participant Flow|Arm B (Comparator): Docetaxel Alone|"Docetaxel (approved chemotherapy treatment for NSCLC):~75 mg/m˄2 IV on Day 1 of each 21-day cycle"
11085812|NCT01500759|OG000|Outcome|Chronic HF With SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11085813|NCT01500759|OG000|Outcome|Chronic HF Without SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11085814|NCT01500759|OG001|Outcome|Chronic HF With SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11085815|NCT01500759|OG000|Outcome|Patients With Chronic HF Without SDB Male|patients with chronic heart failure and no sleep disordered breathing who are male
11085816|NCT01500759|OG001|Outcome|Patients With Chronic Heart Failure and SDB Male|patients with chronic heart failure and sleep disorderd breathing who are male
11085817|NCT01500759|OG000|Outcome|Patients With Chronic HF Without SDB and AF|patients with chronic heart failure and no sleep disordered breathing who have atrial fibrillation (AF)
11085818|NCT01500759|OG001|Outcome|Patients With Chronic Heart Failure and SDB and AF|patients with chronic heart failure and sleep disorderd breathing who have atrial fibrillation (AF)
11085819|NCT01500759|OG000|Outcome|Patients With Chronic HF Without SDB and Ischemic Etiology|patients with chronic heart failure and no sleep disordered breathing who have an ischemic etiology (reduced blood flow to the heart muscle) of HF
11085820|NCT01500759|OG001|Outcome|Patients With Chronic Heart Failure and SDB and Ischemic Etiol|patients with chronic heart failure and sleep disorderd breathing who have an ischemic etiology (reduced blood flow to the heart muscle) of HF
11085821|NCT01500759|OG000|Outcome|Patients With Chronic HF Without SDB and NYHA>III|patients with chronic heart failure and no sleep disordered breathing who are classified as NYHA >=III
11085822|NCT01500759|OG001|Outcome|Patients With Chronic Heart Failure and SDB and NYHA >III|patients with chronic heart failure and sleep disorderd breathing who are classified as NYHA >=III
11085823|NCT01500759|EG000|Reported Event|Chronic HF Without SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11085824|NCT01500759|EG001|Reported Event|Chronic HF With SDB|Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
11085825|NCT01501110|BG000|Baseline|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
11085826|NCT01501110|BG001|Baseline|no Intervention|No intervention / usual care
11085827|NCT01501110|BG002|Baseline|Total|Total of all reporting groups
11085828|NCT01501110|FG000|Participant Flow|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
11085829|NCT01501110|FG001|Participant Flow|no Intervention|No intervention / usual care
11085830|NCT01501110|OG000|Outcome|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
11085831|NCT01501110|OG001|Outcome|no Intervention|No intervention / usual care
11085832|NCT01501110|EG000|Reported Event|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
11085833|NCT01501110|EG001|Reported Event|no Intervention|No intervention / usual care
11085834|NCT01501162|BG000|Baseline|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
11085835|NCT01501162|BG001|Baseline|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
11085836|NCT01501162|BG002|Baseline|Total|Total of all reporting groups
11085837|NCT01501162|FG000|Participant Flow|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
11085838|NCT01501162|FG001|Participant Flow|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
11085839|NCT01501162|OG000|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
11085840|NCT01501162|OG001|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
11085841|NCT01501162|EG000|Reported Event|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
11085842|NCT01501162|EG001|Reported Event|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
11085843|NCT01501929|BG000|Baseline|All Study Participants|After the baseline measurement, all subjects were randomized to receive either nebivolol at the dose of 5 mg once daily or Metoprolol succinate 100 mg once daily, using a double-blind crossover design. If BP remained above 140/90 mmHg during the first follow-up visit, the dose of Nebivolol was increased up to 20 mg once daily and Metoprolol was increased up to 300 mg once daily.
11085844|NCT01501929|FG000|Participant Flow|Metoprolol First, Then Nebivolol|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he/she will continue for a period of 12 weeks. Then the subject will be switched to nebivolol (5-20 mg daily) for a period of 12 weeks.
11085845|NCT01501929|FG001|Participant Flow|Nebivolol First, Then Metoprolol|The subject will be started on nebivolol (5-20 mg daily), which he/she will continue for a period of 12 weeks. Then the subject will be switched to metoprolol succinate (Toprol XL) 100-300mg daily for a period of 12 weeks.
11085846|NCT01501929|OG000|Outcome|Metoprolol|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he/she will continue for a period of 12 weeks. The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.
11085847|NCT01501929|OG001|Outcome|Nebivolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
11085848|NCT01501929|EG000|Reported Event|Initial Treatment With Metoprolol|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he/she will continue for a period of 12 weeks. The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.
11085849|NCT01501929|EG001|Reported Event|Initial Treatment With Nebivolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
11085850|NCT01502033|BG000|Baseline|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
11085851|NCT01502033|FG000|Participant Flow|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
11233802|NCT02431260|OG004|Outcome|Part 1 / Treatment Group A: 22.5 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11085852|NCT01502033|OG000|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
11085853|NCT01502033|OG000|Outcome|Open Label Active Treatment|All participants had unblended treatment
11085854|NCT01502033|OG000|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation: 30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment"
11085855|NCT01502033|EG000|Reported Event|Open Label Active Treatment|All participants had unblinded treatment
11085856|NCT01502072|BG000|Baseline|Oral Ribavirin|Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
11085857|NCT01502072|BG001|Baseline|Inhaled Ribavirin|Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
11085858|NCT01502072|BG002|Baseline|No Ribavirin|No Ribavirin treatment.
11085859|NCT01502072|BG003|Baseline|Total|Total of all reporting groups
11085860|NCT01502072|FG000|Participant Flow|Oral Ribavirin|"Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.~Ribavirin: One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day)."
11085861|NCT01502072|FG001|Participant Flow|Inhaled Ribavirin|Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
11085862|NCT01502072|FG002|Participant Flow|No Ribavirin|No Ribavirin treatment.
11085863|NCT01502072|OG000|Outcome|Oral Ribavirin|Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
11085864|NCT01502072|OG001|Outcome|Inhaled Ribavirin|Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
11085865|NCT01502072|OG002|Outcome|No Ribavirin|No Ribavirin treatment.
11085866|NCT01502072|EG000|Reported Event|Oral Ribavirin|Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
11085867|NCT01502072|EG001|Reported Event|Inhaled Ribavirin|Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
11085868|NCT01502072|EG002|Reported Event|No Ribavirin|No Ribavirin treatment.
11085869|NCT01502228|BG000|Baseline|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
11085870|NCT01502228|FG000|Participant Flow|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
11085871|NCT01502228|OG000|Outcome|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
11085872|NCT01502228|EG000|Reported Event|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
11233803|NCT02431260|OG005|Outcome|Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329|"Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.~Treatment Group A included any advanced solid tumor or lymphoma."
11085873|NCT01502293|BG000|Baseline|Main Study: Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 3-month intervals until disease progression or unacceptable toxicity for up to 5 cycles.
11085874|NCT01502293|BG001|Baseline|Addendum: Regimen A Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles.
11085875|NCT01502293|BG002|Baseline|Addendum: Regimen B Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.
11085876|NCT01502293|BG003|Baseline|Total|Total of all reporting groups
11085877|NCT01502293|FG000|Participant Flow|Main Study: Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 3-month intervals until disease progression or unacceptable toxicity for up to 5 cycles.
11085878|NCT01502293|FG001|Participant Flow|Addendum: Regimen A Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles.
11085879|NCT01502293|FG002|Participant Flow|Addendum: Regimen B Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.
11085880|NCT01502293|OG000|Outcome|Main Study: Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 3-month intervals until disease progression or unacceptable toxicity for up to 5 cycles.
11085881|NCT01502293|OG001|Outcome|Addendum: Regimen A Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles.
11085882|NCT01502293|OG002|Outcome|Addendum: Regimen B Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.
11085883|NCT01502293|OG002|Outcome|Addendum: Regimen B|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.
11085884|NCT01502293|OG001|Outcome|Addendum: Regimen A|Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles.
11085885|NCT01502293|OG002|Outcome|Addendum: Regimen B Tavo-EP|Patients received cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.
11085886|NCT01502293|EG000|Reported Event|Main Study: Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 3-month intervals until disease progression or unacceptable toxicity for up to 5 cycles.
11085887|NCT01502293|EG001|Reported Event|Addendum: Regimen A Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles.
11085888|NCT01502293|EG002|Reported Event|Addendum: Regimen B Tavo-EP|Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.
11085889|NCT01502306|BG000|Baseline|Telephone Counseling|One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
11092109|NCT01537367|OG001|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
11085890|NCT01502306|BG001|Baseline|Phone Counseling & Nicotine Patches|"One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.~Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.~Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists."
11085891|NCT01502306|BG002|Baseline|Phone Counseling, NRT and Incentives|"One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.~Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.~Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).~Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card."
11085892|NCT01502306|BG003|Baseline|Total|Total of all reporting groups
11085893|NCT01502306|FG000|Participant Flow|Telephone Counseling|One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
11085894|NCT01502306|FG001|Participant Flow|Phone Counseling & Nicotine Patches|"One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.~Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.~Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists."
11085895|NCT01502306|FG002|Participant Flow|Phone Counseling, NRT and Incentives|"One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.~Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.~Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).~Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card."
11227822|NCT02387216|OG000|Outcome|Arm A (Experimental): MM-121 in Combination With Docetaxel|"MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle~Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle"
11227823|NCT02387216|OG001|Outcome|Arm B (Comparator): Docetaxel Alone|"Docetaxel (approved chemotherapy treatment for NSCLC):~75 mg/m˄2 IV on Day 1 of each 21-day cycle"
11227824|NCT02387216|EG000|Reported Event|Arm A (Experimental): MM-121 in Combination With Docetaxel|"MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle~Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle"
11227825|NCT02387216|EG001|Reported Event|Arm B (Comparator): Docetaxel Alone|"Docetaxel (approved chemotherapy treatment for NSCLC):~75 mg/m˄2 IV on Day 1 of each 21-day cycle"
11227826|NCT02387268|BG000|Baseline|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
11227827|NCT02387268|FG000|Participant Flow|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
11227828|NCT02387268|OG000|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
11227829|NCT02387268|EG000|Reported Event|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
11227830|NCT02387294|BG000|Baseline|Age Group 1: Children (3-11 Years)|"Intervention: Vaccination with Fluval AB Novo suspension for injection.~Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly."
11085896|NCT01502306|OG000|Outcome|Telephone Counseling|One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
11085897|NCT01502306|OG001|Outcome|Phone Counseling & Nicotine Patches|"One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.~Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.~Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists."
11085898|NCT01502306|OG002|Outcome|Phone Counseling, NRT and Incentives|"One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.~Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.~Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).~Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card."
11085899|NCT01502306|EG000|Reported Event|Telephone Counseling|One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
11085900|NCT01502306|EG001|Reported Event|Phone Counseling & Nicotine Patches|"One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.~Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.~Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists."
11085901|NCT01502306|EG002|Reported Event|Phone Counseling, NRT and Incentives|"One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.~Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.~Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).~Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card."
11085902|NCT01502332|BG000|Baseline|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
11085903|NCT01502332|BG001|Baseline|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
11085904|NCT01502332|BG002|Baseline|Total|Total of all reporting groups
11085905|NCT01502332|FG000|Participant Flow|Intensive Alveolar Recruitment|Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
11085906|NCT01502332|FG001|Participant Flow|Moderate Alveolar Recruitment|Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
11085907|NCT01502332|OG000|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
11085908|NCT01502332|OG001|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
11085909|NCT01502332|EG000|Reported Event|Intensive Alveolar Recruitment ARM|Mechanical ventilation strategy: Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
11227831|NCT02387294|BG001|Baseline|Age Group 2: Adolescents (12-18 Years)|"Intervention: Vaccination with Fluval AB Novo suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11085910|NCT01502332|EG001|Reported Event|Moderate Alveolar Recruitment ARM|Mechanical ventilation strategy: Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
11085911|NCT01502410|BG000|Baseline|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085912|NCT01502410|BG001|Baseline|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085913|NCT01502410|BG002|Baseline|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085914|NCT01502410|BG003|Baseline|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085915|NCT01502410|BG004|Baseline|Total|Total of all reporting groups
11085916|NCT01502410|FG000|Participant Flow|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085917|NCT01502410|FG001|Participant Flow|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085918|NCT01502410|FG002|Participant Flow|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085919|NCT01502410|FG003|Participant Flow|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085920|NCT01502410|OG000|Outcome|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085921|NCT01502410|OG001|Outcome|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
11085922|NCT01502410|OG000|Outcome|Rhabdomyosarcoma and Wilms Tumor|These are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular diagnosed disease. Therefore, both Rhabdomyosarcoma and Wilms Tumor are combined in this analysis.
11085923|NCT01502410|OG000|Outcome|Rhabdomyosarcoma and Wilms Tumor|Serum concentration are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular disease with which the patient was diagnosed and were combined for analysis.
11085924|NCT01502410|OG000|Outcome|Rhabdomyosarcoma and Wilms Tumor|
11085925|NCT01502410|EG000|Reported Event|Group 1 Relapsed/Refractory Rhabdomyosarcoma|Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
11085926|NCT01502410|EG001|Reported Event|Group 2 Relapsed/Refractory Wilms Tumor|Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
11085927|NCT01502423|BG000|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
11227832|NCT02387294|BG002|Baseline|Total|Total of all reporting groups
11227833|NCT02387294|FG000|Participant Flow|Age Group 1: Children (3-11 Years)|"Intervention: Vaccination with Fluval AB Novo~Dosage: half of the single dose"
11085928|NCT01502423|BG001|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
11085929|NCT01502423|BG002|Baseline|Total|Total of all reporting groups
11085930|NCT01502423|FG000|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
11085931|NCT01502423|FG001|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
11085932|NCT01502423|OG000|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
11085933|NCT01502423|OG001|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
11085934|NCT01502423|EG000|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
11085935|NCT01502423|EG001|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
11085936|NCT01502631|BG000|Baseline|SUN13837|Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
11085937|NCT01502631|BG001|Baseline|Placebo|Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
11085938|NCT01502631|BG002|Baseline|Total|Total of all reporting groups
11085939|NCT01502631|FG000|Participant Flow|SUN13837|Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
11085940|NCT01502631|FG001|Participant Flow|Placebo|Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
11085941|NCT01502631|OG000|Outcome|SUN13837|Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
11085942|NCT01502631|OG001|Outcome|Placebo|Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
11085943|NCT01502631|EG000|Reported Event|SUN13837|Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
11085944|NCT01502631|EG001|Reported Event|Placebo|Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
11227834|NCT02387294|FG001|Participant Flow|Age Group 2: Adolescents|"Intervention: Vaccination with Fluval AB Novo~Dosage: single dose"
11085945|NCT01502644|BG000|Baseline|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085946|NCT01502644|BG001|Baseline|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085947|NCT01502644|BG002|Baseline|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085948|NCT01502644|BG003|Baseline|Total|Total of all reporting groups
11085949|NCT01502644|FG000|Participant Flow|Enrolled at Visit 1|All participants who satisfied pre-screening requirements and were enrolled at Visit 1.
11085950|NCT01502644|FG001|Participant Flow|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085951|NCT01502644|FG002|Participant Flow|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085952|NCT01502644|FG003|Participant Flow|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085953|NCT01502644|OG000|Outcome|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085954|NCT01502644|OG001|Outcome|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085955|NCT01502644|OG002|Outcome|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085956|NCT01502644|EG000|Reported Event|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085957|NCT01502644|EG001|Reported Event|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085958|NCT01502644|EG002|Reported Event|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
11085959|NCT01502709|BG000|Baseline|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
11085960|NCT01502709|BG001|Baseline|Placebo Arm|0 participants received placebo
11085961|NCT01502709|BG002|Baseline|Total|Total of all reporting groups
11085962|NCT01502709|FG000|Participant Flow|Caloric Vestibular Neurostimulation|1 treatment of caloric vestibular neurostimulation for 7.5 minutes in the right ear
11085963|NCT01502709|FG001|Participant Flow|Placebo Arm|0 participants received placebo
11085964|NCT01502709|OG000|Outcome|Neurostimulator|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
11085965|NCT01502709|OG001|Outcome|Placebo Arm|0 participants received placebo
11085966|NCT01502709|OG000|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
11085967|NCT01502709|EG000|Reported Event|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
11085968|NCT01502709|EG001|Reported Event|Placebo Arm|0 participants received placebo
11085969|NCT01502761|BG000|Baseline|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
11085970|NCT01502761|BG001|Baseline|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
11085971|NCT01502761|BG002|Baseline|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
11085972|NCT01502761|BG003|Baseline|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
11085973|NCT01502761|BG004|Baseline|Total|Total of all reporting groups
11085974|NCT01502761|FG000|Participant Flow|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
11085975|NCT01502761|FG001|Participant Flow|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
11085976|NCT01502761|FG002|Participant Flow|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
11085977|NCT01502761|FG003|Participant Flow|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
11085978|NCT01502761|OG000|Outcome|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
11085979|NCT01502761|OG001|Outcome|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
11085980|NCT01502761|OG002|Outcome|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
11085981|NCT01502761|OG003|Outcome|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
11085982|NCT01502761|EG000|Reported Event|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
11227835|NCT02387294|OG000|Outcome|Age Group 1: Children (3-11 Years)|"Intervention: Vaccination with Fluval AB Novo suspension for injection.~Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly."
11227836|NCT02387294|OG001|Outcome|Age Group 2: Adolescents|"Intervention: Vaccination with Fluval AB Novo suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11085983|NCT01502761|EG001|Reported Event|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
11085984|NCT01502761|EG002|Reported Event|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
11085985|NCT01502761|EG003|Reported Event|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
11085986|NCT01502787|BG000|Baseline|All Participants|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period , there will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
11085987|NCT01502787|FG000|Participant Flow|Metoprolol First Then Nebivolol|"The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.~Metoprolol succinate: The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."
11085988|NCT01502787|FG001|Participant Flow|Nebivolol First, Then Metoprolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
11085989|NCT01502787|OG000|Outcome|First Intervention Metoprolol: 12 Weeks|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
11085990|NCT01502787|OG001|Outcome|Second Intervention Nebivolol: 24 Weeks|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.
11085991|NCT01502787|OG000|Outcome|Initial Treatment With Metoprolol|"The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.~Metoprolol succinate: The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."
11092110|NCT01537367|OG002|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
11085992|NCT01502787|OG001|Outcome|Initial Treatment With Nebivolol|"The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.~Nebivolol: The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."
11085993|NCT01502787|OG000|Outcome|Metoprolol|Angiotensin II: blood pressure was measured at baseline and during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.
11085994|NCT01502787|OG001|Outcome|Nebivolol|Angiotensin II: blood pressure was measured at baseline and during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.
11085995|NCT01502787|EG000|Reported Event|Metoprolol 21 Subjects|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
11085996|NCT01502787|EG001|Reported Event|Nebivolol 21 Subjects|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
11085997|NCT01502813|BG000|Baseline|Citicoline, Creatine, and Omega-3 Arm|Citicoline, Omega-3 Fatty Acids and Creatine: Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
11085998|NCT01502813|FG000|Participant Flow|Citicoline, Creatine, and Omega-3 Arm|Citicoline, Omega-3 Fatty Acids and Creatine: Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
11085999|NCT01502813|OG000|Outcome|Citicoline, Creatine, and Omega-3 Arm|Citicoline, Omega-3 Fatty Acids and Creatine: Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
11086000|NCT01502813|EG000|Reported Event|Citicoline, Creatine, and Omega-3 Arm|Citicoline, Omega-3 Fatty Acids and Creatine: Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
11086001|NCT01502956|BG000|Baseline|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
11086002|NCT01502956|BG001|Baseline|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
11086003|NCT01502956|BG002|Baseline|Total|Total of all reporting groups
11227837|NCT02387294|OG001|Outcome|Age Group 2: Adolescents (12-18 Years)|"Intervention: Vaccination with Fluval AB Novo suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11086004|NCT01502956|FG000|Participant Flow|InterStim® Device|"The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.~InterStim® device: Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be d"
11086005|NCT01502956|FG001|Participant Flow|Botox® Injection|"Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.~Botox® injection: Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC."
11092111|NCT01537367|EG000|Reported Event|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
11086006|NCT01502956|OG000|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
11086007|NCT01502956|OG001|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
11086008|NCT01502956|EG000|Reported Event|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
11086009|NCT01502956|EG001|Reported Event|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
11086010|NCT01503021|BG000|Baseline|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
11086011|NCT01503021|BG001|Baseline|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
11086012|NCT01503021|BG002|Baseline|Total|Total of all reporting groups
11086013|NCT01503021|FG000|Participant Flow|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
11086014|NCT01503021|FG001|Participant Flow|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
11086015|NCT01503021|OG000|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
11086016|NCT01503021|OG001|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
11086017|NCT01503021|OG002|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
11086018|NCT01503021|OG000|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
11086019|NCT01503021|OG001|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
11086020|NCT01503021|OG000|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
11086021|NCT01503021|EG000|Reported Event|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
11086022|NCT01503021|EG001|Reported Event|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
11086023|NCT01503021|EG002|Reported Event|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
11086024|NCT01503164|BG000|Baseline|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
11086025|NCT01503164|BG001|Baseline|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
11086026|NCT01503164|BG002|Baseline|Total|Total of all reporting groups
11227838|NCT02387294|EG000|Reported Event|Age Group 1: Children (3-11 Years)|"Intervention: Vaccination with Fluval AB Novo suspension for injection.~Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly."
11086027|NCT01503164|FG000|Participant Flow|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
11086028|NCT01503164|FG001|Participant Flow|Lifestyle Counseling|LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.
11086029|NCT01503164|OG000|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
11086030|NCT01503164|OG001|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
11086031|NCT01503164|EG000|Reported Event|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
11086032|NCT01503164|EG001|Reported Event|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
11086033|NCT01503229|BG000|Baseline|Treatment (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given orally~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given orally"
11086034|NCT01503229|FG000|Participant Flow|Treatment (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given orally~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given orally"
11086035|NCT01503229|OG000|Outcome|Treatment (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given orally~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given orally"
11086036|NCT01503229|EG000|Reported Event|Treatment (Abiraterone Acetate and Prednisone)|"Patients receive abiraterone acetate orally once daily and prednisone orally twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Abiraterone Acetate: Given by mouth~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given by mouth"
11086037|NCT01503333|BG000|Baseline|Control|The control condition completed data collection activities and received their usual school offerings, such as physical education.
11086038|NCT01503333|BG001|Baseline|Physical Activity Intervention|"The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school.~Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club."
11086039|NCT01503333|BG002|Baseline|Total|Total of all reporting groups
11086040|NCT01503333|FG000|Participant Flow|Control|The control condition completed data collection activities and received their usual school offerings, such as physical education.
11086041|NCT01503333|FG001|Participant Flow|Physical Activity Intervention|"The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school.~Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club."
11086042|NCT01503333|OG000|Outcome|Control|The control condition completed data collection activities and received their usual school offerings, such as physical education.
11227839|NCT02387294|EG001|Reported Event|Age Group 2: Adolescents (12-18 Years)|"Intervention: Vaccination with Fluval AB Novo suspension for injection.~Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly."
11227840|NCT02387359|BG000|Baseline|Matching Placebo|Placebo tablets dosed once daily for 12 weeks
11227841|NCT02387359|BG001|Baseline|3.0 mg Plecanatide|Plecanatide 3.0 mg tablets dosed once daily for 12 weeks
11227842|NCT02387359|BG002|Baseline|6.0 mg Plecanatide|Plecanatide 6.0 mg tablets dosed once daily for 12 weeks
11227843|NCT02387359|BG003|Baseline|Total|Total of all reporting groups
11227844|NCT02387359|FG000|Participant Flow|Matching Placebo|Placebo tablets dosed once daily for 12 weeks
11086043|NCT01503333|OG001|Outcome|Physical Activity Intervention|"The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school.~Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club."
11086044|NCT01503333|OG000|Outcome|Control|The control group received usual school activities and wore accelerometers 9-months after the Girls on the Move intervention had ended.
11086045|NCT01503333|OG001|Outcome|Physical Activity Intervention|The intervention group wore accelerometers to measure MVPA 9 months after the Girls on the Move intervention had ended.
11086046|NCT01503333|OG000|Outcome|Control|Received usual school activities
11086047|NCT01503333|OG001|Outcome|Intervention|Received Girls on the Move intervention
11086048|NCT01503333|OG000|Outcome|Control|Usual school activities
11086049|NCT01503333|OG001|Outcome|Intervention|Received intervention
11086050|NCT01503333|OG000|Outcome|Control|Usual activities
11086051|NCT01503333|OG000|Outcome|Control|Received Usual school activities
11086052|NCT01503333|EG000|Reported Event|Control|The control condition will complete data collection activities and receive their usual school offerings.
11086053|NCT01503333|EG001|Reported Event|Physical Activity Intervention|"Receiving Physical activity intervention which includes individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.~Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club."
11086054|NCT01503749|BG000|Baseline|Control|"Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells~."
11086055|NCT01503749|BG001|Baseline|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
11086056|NCT01503749|BG002|Baseline|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
11086057|NCT01503749|BG003|Baseline|Total|Total of all reporting groups
11086058|NCT01503749|FG000|Participant Flow|Control|"Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells~."
11086059|NCT01503749|FG001|Participant Flow|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
11086060|NCT01503749|FG002|Participant Flow|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
11086061|NCT01503749|OG000|Outcome|Control|"Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells~."
11086062|NCT01503749|OG001|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
11086063|NCT01503749|OG002|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
11086064|NCT01503749|EG000|Reported Event|Control|"Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells~."
11227845|NCT02387359|FG001|Participant Flow|3.0 mg Plecanatide|Plecanatide 3.0 mg tablets dosed once daily for 12 weeks
11227846|NCT02387359|FG002|Participant Flow|6.0 mg Plecanatide|Plecanatide 6.0 mg tablets dosed once daily for 12 weeks
11086065|NCT01503749|EG001|Reported Event|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
11086066|NCT01503749|EG002|Reported Event|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
11086067|NCT01504204|BG000|Baseline|Medication With Sample and Demonstration|"Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.~Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
11086068|NCT01504204|BG001|Baseline|Medication Without Samples|"Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
11086069|NCT01504204|BG002|Baseline|Total|Total of all reporting groups
11086070|NCT01504204|FG000|Participant Flow|Medication With Sample and Demonstration|Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
11086071|NCT01504204|FG001|Participant Flow|Medication Without Samples|Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
11086072|NCT01504204|OG000|Outcome|Medication With Sample and Demonstration|"Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.~Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
11086073|NCT01504204|OG001|Outcome|Medication Without Samples|"Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
11086074|NCT01504204|EG000|Reported Event|Medication With Sample and Demonstration|"Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.~Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
11086075|NCT01504204|EG001|Reported Event|Medication Without Samples|"Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
11086076|NCT01504412|BG000|Baseline|Placebo|DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
11086077|NCT01504412|BG001|Baseline|Pregabalin|Pregabalin capsules 300 mg/day administered in 2 doses
11086078|NCT01504412|BG002|Baseline|DS-5565 10 mg/Day|DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily).
11086079|NCT01504412|BG003|Baseline|DS-5565 20 mg/Day|DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily).
11227847|NCT02387359|OG000|Outcome|Matching Placebo|Placebo tablets dosed once daily for 12 weeks
11086080|NCT01504412|BG004|Baseline|DS-5565 30 mg/Day|DS-5565 30mg/day, administered in 2 doses (15 mg twice daily).
11086081|NCT01504412|BG005|Baseline|Total|Total of all reporting groups
11086082|NCT01504412|FG000|Participant Flow|Placebo|DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
11086083|NCT01504412|FG001|Participant Flow|Pregabalin|Pregabalin capsules 300 mg/day administered in 2 doses
11086084|NCT01504412|FG002|Participant Flow|DS-5565 10 mg/Day|DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily).
11086085|NCT01504412|FG003|Participant Flow|DS-5565 20 mg/Day|DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily).
11086086|NCT01504412|FG004|Participant Flow|DS-5565 30 mg/Day|DS-5565 30mg/day, administered in 2 doses (15 mg twice daily).
11086087|NCT01504412|OG000|Outcome|Placebo|DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
11086088|NCT01504412|OG001|Outcome|Pregabalin|Pregabalin capsules 300 mg/day administered in 2 doses
11086089|NCT01504412|OG002|Outcome|DS-5565 10 mg/Day|DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily).
11086090|NCT01504412|OG003|Outcome|DS-5565 20 mg/Day|DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily).
11086091|NCT01504412|OG004|Outcome|DS-5565 30 mg/Day|DS-5565 30mg/day, administered in 2 doses (15 mg twice daily).
11086092|NCT01504412|EG000|Reported Event|Placebo|DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
11086093|NCT01504412|EG001|Reported Event|Pregabalin|Pregabalin capsules 300 mg/day administered in 2 doses
11086094|NCT01504412|EG002|Reported Event|DS-5565 10 mg/Day|DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose.
11086095|NCT01504412|EG003|Reported Event|DS-5565 20 mg/Day|DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose.
11086096|NCT01504412|EG004|Reported Event|DS-5565 30 mg/Day|DS-5565 30mg/day, administered in 2 doses (15 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose.
11092112|NCT01537367|EG001|Reported Event|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
11227848|NCT02387359|OG001|Outcome|3.0 mg Plecanatide|Plecanatide 3.0 mg tablets dosed once daily for 12 weeks
11227849|NCT02387359|OG002|Outcome|6.0 mg Plecanatide|Plecanatide 6.0 mg tablets dosed once daily for 12 weeks
11227850|NCT02387359|EG000|Reported Event|Matching Placebo|Placebo tablets dosed once daily for 12 weeks
11227851|NCT02387359|EG001|Reported Event|3.0 mg Plecanatide|Plecanatide 3.0 mg tablets dosed once daily for 12 weeks
11227852|NCT02387359|EG002|Reported Event|6.0 mg Plecanatide|Plecanatide 6.0 mg tablets dosed once daily for 12 weeks
11092113|NCT01537367|EG002|Reported Event|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
11092114|NCT01537393|BG000|Baseline|Preservation Time Group 1|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
11092115|NCT01537393|BG001|Baseline|Preservation Time Group 2|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
11092116|NCT01537393|BG002|Baseline|Total|Total of all reporting groups
11092117|NCT01537393|FG000|Participant Flow|0-7d Preservation Time (PT) Group|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
11092118|NCT01537393|FG001|Participant Flow|8-14d Preservation Time (PT) Group|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
11092119|NCT01537393|OG000|Outcome|Preservation Time Group 1|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
11092120|NCT01537393|OG001|Outcome|Preservation Time Group 2|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
11092121|NCT01537393|EG000|Reported Event|0-7d Preservation Time Group|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
11092122|NCT01537393|EG001|Reported Event|8-14d Preservation Time Group|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
11227853|NCT02387372|BG000|Baseline|Mechanically Ventilated|"Participants with proven or suspected pneumonia, undergoing mechanical ventilation will receive 4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:~Those with Creatinine clearance (CLCR) > 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours~Those with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours~Those with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours"
11227854|NCT02387372|BG001|Baseline|Critically Ill|Critically ill participants with CLCR ≥180 mL/min (as calculated by the Cockcroft-Gault equation) will receive a single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion.
11227855|NCT02387372|BG002|Baseline|Total|Total of all reporting groups
11227856|NCT02387372|FG000|Participant Flow|Mechanically Ventilated|"Participants with proven or suspected pneumonia, undergoing mechanical ventilation will receive 4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:~Those with Creatinine clearance (CLCR) > 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours~Those with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours~Those with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours"
11227857|NCT02387372|FG001|Participant Flow|Critically Ill|Critically ill participants with CLCR ≥180 mL/min (as calculated by the Cockcroft-Gault equation) will receive a single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion.
11227858|NCT02387372|OG000|Outcome|Mechanically Ventilated- Ceftolozane|"Participants with proven or suspected pneumonia, undergoing mechanical ventilation will receive 4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:~Those with Creatinine clearance (CLCR) > 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours~Those with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours~Those with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours"
11233804|NCT02431260|OG006|Outcome|Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11086097|NCT01504477|BG000|Baseline|Combination of Panitumumab and Bortezomib|"IV panitumumab and bortezomib~Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.~Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle."
11086098|NCT01504477|FG000|Participant Flow|Combination of Panitumumab and Bortezomib|"IV panitumumab and bortezomib~Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.~Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle."
11086099|NCT01504477|OG000|Outcome|Combination of Panitumumab and Bortezomib|"IV panitumumab and bortezomib~Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.~Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle."
11086100|NCT01504477|EG000|Reported Event|Combination of Panitumumab and Bortezomib|"IV panitumumab and bortezomib~Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.~Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle."
11086101|NCT01504672|BG000|Baseline|Intervention Group|An intervention as described is performed for the people in the intervention group.
11086102|NCT01504672|BG001|Baseline|Control Group|No intervention is performed.
11086103|NCT01504672|BG002|Baseline|Total|Total of all reporting groups
11086104|NCT01504672|FG000|Participant Flow|Intervention Group|"Medication review: In the intervention, the pharmacist will evaluate:~Is there an indication for the drug?~Has the drug desired effect?~Is the dose correct and dosing scheme correct?~Side effects, contraindications, inappropriate drugs~Interactions~Treatment time~Cost effectiveness~Adherence to recommendation list~Problems with handling the drugs (for example crushing of the tablets)~Untreated indication~Double medications~Administration of drugs"
11086105|NCT01504672|FG001|Participant Flow|Control Group|Usual Care where no medication review is performed by clinical pharmacists
11227859|NCT02387372|OG001|Outcome|Mechanically Ventilated -Tazobactam|"Participants with proven or suspected pneumonia, undergoing mechanical ventilation will receive 4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:~Those with Creatinine clearance (CLCR) > 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours~Those with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours~Those with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours"
11086106|NCT01504672|OG000|Outcome|Intervention Group|"Medication review: In the intervention, the pharmacist will evaluate:~Is there an indication for the drug?~Has the drug desired effect?~Is the dose correct and dosing scheme correct?~Side effects, contraindications, inappropriate drugs~Interactions~Treatment time~Cost effectiveness~Adherence to recommendation list~Problems with handling the drugs (for example crushing of the tablets)~Untreated indication~Double medications~Administration of drugs"
11086107|NCT01504672|OG001|Outcome|Control Group|Usual Care where no medication review is performed by clinical pharmacists
11086108|NCT01504672|OG000|Outcome|Medication Review|"Medication review: In the intervention, the pharmacist will evaluate:~Is there an indication for the drug?~Has the drug desired effect?~Is the dose correct and dosing scheme correct?~Side effects, contraindications, inappropriate drugs~Interactions~Treatment time~Cost effectiveness~Adherence to recommendation list~Problems with handling the drugs (for example crushing of the tablets)~Untreated indication~Double medications~Administration of drugs"
11086109|NCT01504672|OG001|Outcome|Usual Care|
11086110|NCT01504672|EG000|Reported Event|Intervention Group|"Medication review: In the intervention, the pharmacist will evaluate:~Is there an indication for the drug?~Has the drug desired effect?~Is the dose correct and dosing scheme correct?~Side effects, contraindications, inappropriate drugs~Interactions~Treatment time~Cost effectiveness~Adherence to recommendation list~Problems with handling the drugs (for example crushing of the tablets)~Untreated indication~Double medications~Administration of drugs"
11086111|NCT01504672|EG001|Reported Event|Control Group|Usual Care where no medication review is performed by clinical pharmacists
11086112|NCT01504711|BG000|Baseline|Treatment (Nausea and Vomiting Prophylaxis)|"Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.~fosaprepitant dimeglumine: Given IV"
11086113|NCT01504711|FG000|Participant Flow|Treatment (Nausea and Vomiting Prophylaxis)|"Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.~fosaprepitant dimeglumine: Given IV"
11086114|NCT01504711|OG000|Outcome|Treatment (Nausea and Vomiting Prophylaxis)|"Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.~fosaprepitant dimeglumine: Given IV"
11086115|NCT01504711|EG000|Reported Event|All Participants|All participants
11086116|NCT01504841|BG000|Baseline|Cohort I: Treatment Experienced, 2 to 6 Years of Age|"Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086117|NCT01504841|BG001|Baseline|Cohort II: Treatment Experienced, 1 to 2 Years of Age|"Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086118|NCT01504841|BG002|Baseline|Cohort III: Treatment Experienced, 2 Months to 1 Year of Age|"Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086119|NCT01504841|BG003|Baseline|Total|Total of all reporting groups
11086120|NCT01504841|FG000|Participant Flow|Cohort I: Treatment Experienced, 2 to 6 Years of Age|"Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086121|NCT01504841|FG001|Participant Flow|Cohort II: Treatment Experienced, 1 to 2 Years of Age|"Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086122|NCT01504841|FG002|Participant Flow|Cohort III: Treatment Experienced, 2 Months to 1 Year of Age|"Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086123|NCT01504841|OG000|Outcome|Cohort I: Treatment Experienced, 2 to 6 Years of Age|"Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086124|NCT01504841|OG001|Outcome|Cohort II: Treatment Experienced, 1 to 2 Years of Age|"Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086125|NCT01504841|OG002|Outcome|Cohort III: Treatment Experienced, 2 Months to 1 Year of Age|"Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086126|NCT01504841|EG000|Reported Event|Cohort I: Treatment Experienced, 2 to 6 Years of Age|"Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086127|NCT01504841|EG001|Reported Event|Cohort II: Treatment Experienced, 1 to 2 Years of Age|"Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.~Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol."
11086128|NCT01504854|BG000|Baseline|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
11086129|NCT01504854|BG001|Baseline|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
11086130|NCT01504854|BG002|Baseline|Total|Total of all reporting groups
11086131|NCT01504854|FG000|Participant Flow|Resveratrol|"Subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
11086132|NCT01504854|FG001|Participant Flow|Placebo|"Subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
11086133|NCT01504854|OG000|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
11086134|NCT01504854|OG001|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
11086135|NCT01504854|EG000|Reported Event|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
11086136|NCT01504854|EG001|Reported Event|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
11086137|NCT01504867|BG000|Baseline|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
11086138|NCT01504867|BG001|Baseline|Placebo|This group received matching lactose powder filled capsules on days 1-7.
11086139|NCT01504867|BG002|Baseline|Total|Total of all reporting groups
11086140|NCT01504867|FG000|Participant Flow|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
11086141|NCT01504867|FG001|Participant Flow|Placebo|This group received matching lactose powder filled capsules on days 1-7.
11086142|NCT01504867|OG000|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
11086143|NCT01504867|OG001|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
11086144|NCT01504867|EG000|Reported Event|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
11086145|NCT01504867|EG001|Reported Event|Placebo|This group received matching lactose powder filled capsules on days 1-7.
11086146|NCT01504958|BG000|Baseline|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
11227860|NCT02387372|OG000|Outcome|Mechanically Ventilated - Ceftolozane|"Participants with proven or suspected pneumonia, undergoing mechanical ventilation will receive 4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:~Those with Creatinine clearance (CLCR) > 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours~Those with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours~Those with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours"
11227861|NCT02387372|OG001|Outcome|Mechanically Ventilated - Tazobactam|"Participants with proven or suspected pneumonia, undergoing mechanical ventilation will receive 4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:~Those with Creatinine clearance (CLCR) > 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours~Those with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours~Those with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours"
11086147|NCT01504958|BG001|Baseline|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
11086148|NCT01504958|BG002|Baseline|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
11086149|NCT01504958|BG003|Baseline|Total|Total of all reporting groups
11086150|NCT01504958|FG000|Participant Flow|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
11086151|NCT01504958|FG001|Participant Flow|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
11086152|NCT01504958|FG002|Participant Flow|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
11086153|NCT01504958|OG000|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
11086154|NCT01504958|OG001|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
11086155|NCT01504958|OG002|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
11086156|NCT01504958|EG000|Reported Event|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
11086157|NCT01504958|EG001|Reported Event|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
11086158|NCT01504958|EG002|Reported Event|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
11086159|NCT01504971|BG000|Baseline|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire~pH monitoring: 24-hour pH monitoring~Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI~rabeprazole: 10mg, bid, p.o."
11086160|NCT01504971|FG000|Participant Flow|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire~pH monitoring: 24-hour pH monitoring~Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI~rabeprazole: 10mg, bid, p.o."
11086161|NCT01504971|OG000|Outcome|Participants|Diagnostic capabilities of White-light Imaging on Gastroesophageal Reflux Disease
11086162|NCT01504971|OG001|Outcome|Participants Same to arm1|Diagnostic capabilities of Autofluorescence Imaging on Gastroesophageal Reflux Disease
11086163|NCT01504971|OG002|Outcome|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
11086164|NCT01504971|EG000|Reported Event|Participants|Diagnostic capabilities of WLI in the diagnosis of GERD
11086165|NCT01504971|EG001|Reported Event|Participants Same to arm1|Diagnostic capabilities of AFI in the diagnosis of GERD
11086166|NCT01504971|EG002|Reported Event|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
11086167|NCT01504997|BG000|Baseline|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
11227862|NCT02387372|OG000|Outcome|Mechanically Ventilated|"Participants with proven or suspected pneumonia, undergoing mechanical ventilation will receive 4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:~Those with Creatinine clearance (CLCR) > 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours~Those with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours~Those with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours"
11227863|NCT02387372|OG001|Outcome|Critically Ill|Critically ill participants with CLCR ≥180 mL/min (as calculated by the Cockcroft-Gault equation) will receive a single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion.
11086168|NCT01504997|FG000|Participant Flow|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
11086169|NCT01504997|OG000|Outcome|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
11086170|NCT01504997|EG000|Reported Event|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
11086171|NCT01505010|BG000|Baseline|Control Group|"Standard antihypertensive drug treatment~Renal denervation: Renal denervation in the intervention group"
11086172|NCT01505010|BG001|Baseline|Intervention Group|"Renal denervation plus standard antihypertensive drug treatment~Renal denervation: Renal denervation in the intervention group"
11086173|NCT01505010|BG002|Baseline|Total|Total of all reporting groups
11086174|NCT01505010|FG000|Participant Flow|Control Group|Standard antihypertensive drug treatment
11086175|NCT01505010|FG001|Participant Flow|Intervention Group|"Renal denervation plus standard antihypertensive drug treatment~Renal denervation: Renal denervation in the intervention group"
11086176|NCT01505010|OG000|Outcome|Control Group|Standard antihypertensive drug treatment
11086177|NCT01505010|OG001|Outcome|Intervention Group|"Renal denervation plus standard antihypertensive drug treatment~Renal denervation: Renal denervation in the intervention group"
11086178|NCT01505010|EG000|Reported Event|Control Group|Standard antihypertensive drug treatment
11227864|NCT02387372|OG000|Outcome|Critically Ill - Ceftolozane|Critically ill participants with CLCR ≥180 mL/min (as calculated by the Cockcroft-Gault equation) will receive a single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion.
11227865|NCT02387372|OG001|Outcome|Critically Ill - Tazobactam|Critically ill participants with CLCR ≥180 mL/min (as calculated by the Cockcroft-Gault equation) will receive a single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion.
11227866|NCT02387372|EG000|Reported Event|Mechanically Ventilated: 3 g Ceftolozane/Tazobactam|Participants with proven or suspected pneumonia, undergoing mechanical ventilation received 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion
11086179|NCT01505010|EG001|Reported Event|Intervention Group|Renal denervation plus standard antihypertensive drug treatment
11086180|NCT01505114|BG000|Baseline|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
11086181|NCT01505114|BG001|Baseline|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
11086182|NCT01505114|BG002|Baseline|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48"
11086183|NCT01505114|BG003|Baseline|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Maraviroc placebo: Once daily from Week 0 through Week 48"
11086184|NCT01505114|BG004|Baseline|Total|Total of all reporting groups
11086185|NCT01505114|FG000|Participant Flow|MVC Only|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
11086186|NCT01505114|FG001|Participant Flow|MVC + FTC|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
11086187|NCT01505114|FG002|Participant Flow|MVC + TDF|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48"
11086188|NCT01505114|FG003|Participant Flow|TDF + FTC|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Maraviroc placebo: Once daily from Week 0 through Week 48"
11086189|NCT01505114|OG000|Outcome|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
11086190|NCT01505114|OG001|Outcome|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
11086191|NCT01505114|OG002|Outcome|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48"
11086192|NCT01505114|OG003|Outcome|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Maraviroc placebo: Once daily from Week 0 through Week 48"
11086193|NCT01505114|EG000|Reported Event|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
11086194|NCT01505114|EG001|Reported Event|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
11227867|NCT02387372|EG001|Reported Event|Mechanically Ventilated: 1.5 g Ceftolozane/Tazobactam|Participants with proven or suspected pneumonia, undergoing mechanical ventilation received 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion
11227868|NCT02387372|EG002|Reported Event|Mechanically Ventilated: 0.75 g Ceftolozane/Tazobactam|Participants with proven or suspected pneumonia, undergoing mechanical ventilation received 4-6 doses of 0.75 g ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion
11227869|NCT02387372|EG003|Reported Event|Critically Ill: 3 g Ceftolozane/Tazobactam|Critically ill participants with CLCR ≥180 mL/min (as calculated by the Cockcroft-Gault equation) received a single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion.
11086195|NCT01505114|EG002|Reported Event|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48"
11227870|NCT02387476|BG000|Baseline|FRESCA Mask First CPAP Mask Second|One night using FRESCA nasal mask and the second night using patient provided CPAP
11086196|NCT01505114|EG003|Reported Event|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Maraviroc placebo: Once daily from Week 0 through Week 48"
11086197|NCT01505166|BG000|Baseline|Vigil™ Vaccine (Part 1) 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086198|NCT01505166|BG001|Baseline|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086199|NCT01505166|BG002|Baseline|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086200|NCT01505166|BG003|Baseline|Total|Total of all reporting groups
11227871|NCT02387476|BG001|Baseline|CPAP Mask First and CPAP Mask Second|One night using patient providing CPAP nasal mask and second night using FRESCA mask
11227872|NCT02387476|BG002|Baseline|Total|Total of all reporting groups
11227873|NCT02387476|FG000|Participant Flow|FRESCA Mask First - CPAP Second|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
11227874|NCT02387476|FG001|Participant Flow|CPAP Mask - FRESCA Mask Second|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
11227875|NCT02387476|OG000|Outcome|FRESCA Mask First Night|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
11227876|NCT02387476|OG001|Outcome|CPAP Mask First Night|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
11086201|NCT01505166|FG000|Participant Flow|Vigil™ Vaccine (Part 1) - 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086202|NCT01505166|FG001|Participant Flow|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086203|NCT01505166|FG002|Participant Flow|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086204|NCT01505166|OG000|Outcome|Vigil™ Vaccine (Part 1) - 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086205|NCT01505166|OG000|Outcome|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11227877|NCT02387476|OG000|Outcome|"FRESCA Mask First Night | CPAP Second Night"|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
11227878|NCT02387476|OG001|Outcome|"CPAP Mask First Night | FRESCA Mask Second Night"|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
11227879|NCT02387476|EG000|Reported Event|FRESCA Mask|Each patient used both devices, the analysis of the Adverse Events is recorded for both technology. This arm is associated with the FRESCA Mask.
11227880|NCT02387476|EG001|Reported Event|CPAP Mask|Each patient used both devices, the analysis of the Adverse Events is recorded for both technology. This arm is associated with the CPAP Mask.
11227881|NCT02387502|BG000|Baseline|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
11227882|NCT02387502|BG001|Baseline|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
11227883|NCT02387502|BG002|Baseline|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
11227884|NCT02387502|BG003|Baseline|Total|Total of all reporting groups
11233805|NCT02431260|OG007|Outcome|Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11233806|NCT02431260|OG008|Outcome|Part 1 / Treatment Group A: 20 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11086206|NCT01505166|OG001|Outcome|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086207|NCT01505166|OG000|Outcome|Vigil™ Vaccine (6 Patient run-in)|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086208|NCT01505166|OG000|Outcome|Vigil™ Vaccine (Part 1) 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086209|NCT01505166|EG000|Reported Event|Vigil™|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086210|NCT01505166|EG001|Reported Event|Placebo|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086211|NCT01505166|EG002|Reported Event|Vigil™ Vaccine (6 Patient run-in)|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
11086212|NCT01505179|BG000|Baseline|Ranolazine Group|Patients with be given 500 mg Ranolazine by mouth twice a day for three days, and then the dose will be increased to 1000 mg by mouth twice daily thereafter. (patients who concurrently take moderate CYP3A inhibitors including diltiazem, verapamil, aprepitant, erythromycin, and fluconazole will continue to 500 mg by mouth twice a day for the entire dosing period)
11086213|NCT01505179|BG001|Baseline|Placebo Group|Patients will be given Placebo matching the appearance of Ranolazine as 1 tab twice a day for 3 days, then increasing to 2 tabs twice a day thereafter (patients who concurrently take moderate CYP3A inhibitors, will be given 1 tab twice daily for the entire dosing period)
11086214|NCT01505179|BG002|Baseline|Total|Total of all reporting groups
11086215|NCT01505179|FG000|Participant Flow|Ranolazine Group|Patients with be given 500 mg Ranolazine by mouth twice a day for three days, and then the dose will be increased to 1000 mg by mouth twice daily thereafter. (patients who concurrently take moderate CYP3A inhibitors including diltiazem, verapamil, aprepitant, erythromycin, and fluconazole will continue to 500 mg by mouth twice a day for the entire dosing period)
11086216|NCT01505179|FG001|Participant Flow|Placebo Group|Patients will be given Placebo matching the appearance of Ranolazine as 1 tab twice a day for 3 days, then increasing to 2 tabs twice a day thereafter (patients who concurrently take moderate CYP3A inhibitors, will be given 1 tab twice daily for the entire dosing period)
11086217|NCT01505179|OG000|Outcome|Ranolazine Group|Patients with be given 500 mg Ranolazine by mouth twice a day for three days, and then the dose will be increased to 1000 mg by mouth twice daily thereafter. (patients who concurrently take moderate CYP3A inhibitors including diltiazem, verapamil, aprepitant, erythromycin, and fluconazole will continue to 500 mg by mouth twice a day for the entire dosing period)
11086218|NCT01505179|OG001|Outcome|Placebo Group|Patients will be given Placebo matching the appearance of Ranolazine as 1 tab twice a day for 3 days, then increasing to 2 tabs twice a day thereafter (patients who concurrently take moderate CYP3A inhibitors, will be given 1 tab twice daily for the entire dosing period)
11233807|NCT02431260|OG009|Outcome|Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11086219|NCT01505179|EG000|Reported Event|Ranolazine Group|Patients with be given 500 mg Ranolazine by mouth twice a day for three days, and then the dose will be increased to 1000 mg by mouth twice daily thereafter. (patients who concurrently take moderate CYP3A inhibitors including diltiazem, verapamil, aprepitant, erythromycin, and fluconazole will continue to 500 mg by mouth twice a day for the entire dosing period)
11086220|NCT01505179|EG001|Reported Event|Placebo Group|Patients will be given Placebo matching the appearance of Ranolazine as 1 tab twice a day for 3 days, then increasing to 2 tabs twice a day thereafter (patients who concurrently take moderate CYP3A inhibitors, will be given 1 tab twice daily for the entire dosing period)
11086221|NCT01505374|BG000|Baseline|All Study Participants|
11086222|NCT01505374|FG000|Participant Flow|Study Technique Right Leg, Control Technique Left Leg|
11086223|NCT01505374|FG001|Participant Flow|Study Technique Left Leg, Control Technique Right Leg|
11086224|NCT01505374|OG000|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
11086225|NCT01505374|OG001|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
11086226|NCT01505374|OG000|Outcome|All Patients|
11086227|NCT01505374|EG000|Reported Event|Study Technique: Saphenous Nerve Block|
11086228|NCT01505374|EG001|Reported Event|Control Technique: Femoral Nerve Block|
11086229|NCT01505387|BG000|Baseline|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
11086230|NCT01505387|BG001|Baseline|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
11086231|NCT01505387|BG002|Baseline|Total|Total of all reporting groups
11086232|NCT01505387|FG000|Participant Flow|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
11086233|NCT01505387|FG001|Participant Flow|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
11086234|NCT01505387|OG000|Outcome|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
11086235|NCT01505387|OG001|Outcome|Litramine|"Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
11086236|NCT01505387|EG000|Reported Event|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
11086237|NCT01505387|EG001|Reported Event|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
11086238|NCT01505491|BG000|Baseline|BI 695501|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
11086239|NCT01505491|BG001|Baseline|Humira®US|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
11086240|NCT01505491|BG002|Baseline|Humira®EU|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
11086241|NCT01505491|BG003|Baseline|Total|Total of all reporting groups
11086242|NCT01505491|FG000|Participant Flow|BI 695501|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
11086243|NCT01505491|FG001|Participant Flow|Humira®US|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
11086244|NCT01505491|FG002|Participant Flow|Humira®EU|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
11086245|NCT01505491|OG000|Outcome|BI 695501|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
11086246|NCT01505491|OG001|Outcome|Humira®US|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
11086247|NCT01505491|OG002|Outcome|Humira®EU|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
11086248|NCT01505491|EG000|Reported Event|BI 695501|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
11086249|NCT01505491|EG001|Reported Event|Humira®US|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
11086250|NCT01505491|EG002|Reported Event|Humira®EU|Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
11086251|NCT01505530|BG000|Baseline|300 mg LY2495655 + Chemotherapy|300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
11086252|NCT01505530|BG001|Baseline|100 mg LY2495655 + Chemotherapy|100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
11086253|NCT01505530|BG002|Baseline|Placebo + Chemotherapy|Placebo in combination with standard of care chemotherapy (investigator's choice).
11086254|NCT01505530|BG003|Baseline|Total|Total of all reporting groups
11086255|NCT01505530|FG000|Participant Flow|300 mg LY2495655 + Chemotherapy|300 milligram (mg) LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
11086256|NCT01505530|FG001|Participant Flow|100 mg LY2495655 + Chemotherapy|100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
11086257|NCT01505530|FG002|Participant Flow|Placebo + Chemotherapy|Placebo in combination with standard of care chemotherapy (investigator's choice).
11086258|NCT01505530|OG000|Outcome|300 mg LY2495655 + Chemotherapy|300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
11086259|NCT01505530|OG001|Outcome|100 mg LY2495655 + Chemotherapy|100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
11086260|NCT01505530|OG002|Outcome|Placebo + Chemotherapy|Placebo in combination with standard of care chemotherapy (investigator's choice).
11086261|NCT01505530|EG000|Reported Event|300 mg LY2495655|"300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).~LY2495655: Intravenous (IV) treatment every 14 days while on study."
11086262|NCT01505530|EG001|Reported Event|100 mg LY2495655|"100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).~LY2495655: Intravenous (IV) treatment every 14 days while on study."
11086263|NCT01505530|EG002|Reported Event|Placebo|"Placebo in combination with standard of care chemotherapy (investigator's choice).~Placebo: Intravenous (IV) treatment every 14 days while on study."
11086264|NCT01505634|BG000|Baseline|Relebactam 250 mg With Imipenem/Cilastatin|Relebactam 250 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086265|NCT01505634|BG001|Baseline|Relebactam 125 mg With Imipenem/Cilastatin|Relebactam 125 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086266|NCT01505634|BG002|Baseline|Relebactam Placebo With Imipenem/Cilastatin|Matching placebo for relebactam (0.9% normal saline) IV co-administered with 500 mg dose of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086267|NCT01505634|BG003|Baseline|Total|Total of all reporting groups
11086268|NCT01505634|FG000|Participant Flow|Relebactam 250 mg With Imipenem/Cilastatin|Relebactam 250 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086269|NCT01505634|FG001|Participant Flow|Relebactam 125 mg With Imipenem/Cilastatin|Relebactam 125 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086270|NCT01505634|FG002|Participant Flow|Relebactam Placebo With Imipenem/Cilastatin|Matching placebo for relebactam (0.9% normal saline) IV co-administered with 500 mg dose of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086271|NCT01505634|OG000|Outcome|Relebactam 250 mg With Imipenem/Cilastatin|Relebactam 250 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086272|NCT01505634|OG001|Outcome|Relebactam 125 mg With Imipenem/Cilastatin|Relebactam 125 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086273|NCT01505634|OG002|Outcome|Relebactam Placebo With Imipenem/Cilastatin|Matching placebo for relebactam (0.9% normal saline) IV co-administered with 500 mg dose of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11227885|NCT02387502|FG000|Participant Flow|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
11233808|NCT02431260|OG010|Outcome|Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11086274|NCT01505634|EG000|Reported Event|Relebactam 250 mg With Imipenem/Cilastatin|Relebactam 250 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086275|NCT01505634|EG001|Reported Event|Relebactam 125 mg With Imipenem/Cilastatin|Relebactam 125 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086276|NCT01505634|EG002|Reported Event|Relebactam Placebo With Imipenem/Cilastatin|Matching placebo for relebactam (0.9% normal saline) IV co-administered with 500 mg dose of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days.
11086277|NCT01505647|BG000|Baseline|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
11086278|NCT01505647|BG001|Baseline|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
11086279|NCT01505647|BG002|Baseline|Total|Total of all reporting groups
11086280|NCT01505647|FG000|Participant Flow|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live Alternative Manufacturing Process (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
11086281|NCT01505647|FG001|Participant Flow|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
11086282|NCT01505647|OG000|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
11086283|NCT01505647|OG001|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
11086284|NCT01505647|EG000|Reported Event|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
11086285|NCT01505647|EG001|Reported Event|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
11086286|NCT01505673|BG000|Baseline|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
11086287|NCT01505673|BG001|Baseline|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
11086288|NCT01505673|BG002|Baseline|Total|Total of all reporting groups
11086289|NCT01505673|FG000|Participant Flow|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
11086290|NCT01505673|FG001|Participant Flow|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
11086291|NCT01505673|OG000|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
11086292|NCT01505673|OG001|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
11086293|NCT01505673|EG000|Reported Event|Liraglutide|Liraglutide: Liraglutide 1.8mg injected subcutaneously from pen device once daily for 6-months
11086294|NCT01505673|EG001|Reported Event|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
11086295|NCT01505764|BG000|Baseline|Arm 1 (Anamorelin HCl)|Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
11086296|NCT01505764|BG001|Baseline|Arm 2 (Placebo)|Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
11086297|NCT01505764|BG002|Baseline|Total|Total of all reporting groups
11086298|NCT01505764|FG000|Participant Flow|Arm 1 (Anamorelin HCl)|Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
11086299|NCT01505764|FG001|Participant Flow|Arm 2 (Placebo)|Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
11086300|NCT01505764|OG000|Outcome|Arm 1 (Anamorelin HCl)|Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
11086301|NCT01505764|OG001|Outcome|Arm 2 (Placebo)|Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
11086302|NCT01505764|OG000|Outcome|Arm 1 (Anamorelin HCl)|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
11086303|NCT01505764|EG000|Reported Event|Arm 1 (Anamorelin HCl)|Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
11086304|NCT01505764|EG001|Reported Event|Arm 2 (Placebo)|Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
11086305|NCT01505868|BG000|Baseline|Phase I Cabazitaxel + Carboplatin Dose Zero|Intravenous cabazitaxel 20 mg/m2 and carboplatin AUC 3 every 21 days up to 10 doses
11086306|NCT01505868|BG001|Baseline|Phase I Cabazitaxel + Carboplatin Dose One|Intravenous cabazitaxel 20 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
11086307|NCT01505868|BG002|Baseline|Phase I Cabazitaxel + Carboplatin Dose Two|Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
11086308|NCT01505868|BG003|Baseline|Phase II Cabazitaxel|Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
11086309|NCT01505868|BG004|Baseline|Phase II Cabazitaxel + Carboplatin|Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
11086310|NCT01505868|BG005|Baseline|Total|Total of all reporting groups
11086311|NCT01505868|FG000|Participant Flow|Phase I Cabazitaxel + Carboplatin Dose Zero|Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 3 mg/mL per min every 21 days
11086312|NCT01505868|FG001|Participant Flow|Phase I Cabazitaxel + Carboplatin Dose One|Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
11086313|NCT01505868|FG002|Participant Flow|Phase I Cabazitaxel + Carboplatin Dose Two|Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
11086314|NCT01505868|FG003|Participant Flow|Phase II Cabazitaxel|Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
11086315|NCT01505868|FG004|Participant Flow|Phase II Cabazitaxel + Carboplatin|Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
11086316|NCT01505868|OG000|Outcome|Phase I Cabazitaxel + Carboplatin|Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
11086317|NCT01505868|OG000|Outcome|Phase II Cabazitaxel|Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
11086318|NCT01505868|OG001|Outcome|Phase II Cabazitaxel + Carboplatin|Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
11086319|NCT01505868|OG000|Outcome|AVPC-MS Postive|Immunochemistry positive for AVPC-MS
11086320|NCT01505868|OG001|Outcome|AVPC-MS Negative|Immunochemistry negative for AVPC-MS
11086321|NCT01505868|EG000|Reported Event|Phase I Cabazitaxel + Carboplatin Dose Zero|Intravenous cabazitaxel 20mg/m2 and carboplatin area under the curve (AUC) 3mg/mL per min every 21 days
11086322|NCT01505868|EG001|Reported Event|Phase I Cabazitaxel + Carboplatin Dose One|Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
11086323|NCT01505868|EG002|Reported Event|Phase I Cabazitaxel + Carboplatin Dose Two|Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
11086324|NCT01505868|EG003|Reported Event|Phase II Cabazitaxel|Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
11086325|NCT01505868|EG004|Reported Event|Phase II Cabazitaxel + Carboplatin|Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
11086326|NCT01505881|BG000|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
11086327|NCT01505881|BG001|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
11086328|NCT01505881|BG002|Baseline|Total|Total of all reporting groups
11086329|NCT01505881|FG000|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
11086330|NCT01505881|FG001|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
11086331|NCT01505881|OG000|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
11086332|NCT01505881|OG001|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
11086333|NCT01505881|OG001|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator.
11086334|NCT01505881|EG000|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
11086335|NCT01505881|EG001|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
11086336|NCT01505933|BG000|Baseline|Dexmedetomidine|"Dexmedetomidine: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.~After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate."
11086337|NCT01505933|BG001|Baseline|Propofol|"propofol: Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.~After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.~Image acquisitions will be repeated approximately 5 min after the increase in infusion rate."
11086338|NCT01505933|BG002|Baseline|Total|Total of all reporting groups
11086339|NCT01505933|FG000|Participant Flow|Dexmedetomidine|"Dexmedetomidine: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.~After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate."
11086340|NCT01505933|FG001|Participant Flow|Propofol|"propofol: Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.~After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.~Image acquisitions will be repeated approximately 5 min after the increase in infusion rate."
11086341|NCT01505933|OG000|Outcome|Dexmedetomidine|Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0
11086342|NCT01505933|OG001|Outcome|Propofol|Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0
11086343|NCT01505933|EG000|Reported Event|Dexmedetomidine|Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0
11086344|NCT01505933|EG001|Reported Event|Propofol|Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0
11086345|NCT01506193|BG000|Baseline|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086346|NCT01506193|BG001|Baseline|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086347|NCT01506193|BG002|Baseline|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086348|NCT01506193|BG003|Baseline|Total|Total of all reporting groups
11086349|NCT01506193|FG000|Participant Flow|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086350|NCT01506193|FG001|Participant Flow|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11227886|NCT02387502|FG001|Participant Flow|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
11233809|NCT02431260|OG011|Outcome|Part 1 / Treatment Group B: 20 MG BID INCB054329|Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
11086351|NCT01506193|FG002|Participant Flow|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086352|NCT01506193|OG000|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086353|NCT01506193|OG001|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086354|NCT01506193|OG001|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086355|NCT01506193|OG002|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086356|NCT01506193|EG000|Reported Event|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086357|NCT01506193|EG001|Reported Event|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086358|NCT01506193|EG002|Reported Event|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
11086359|NCT01506271|BG000|Baseline|Relebactam 250 mg With Imipenem/Cilastatin|Participants received relebactam 250 mg IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086360|NCT01506271|BG001|Baseline|Relebactam 125 mg With Imipenem/Cilastatin|Participants received relebactam 125 mg IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086361|NCT01506271|BG002|Baseline|Placebo to Relebactam With Imipenem/Cilastatin|Participants received matching placebo to relebactam (normal saline 0.9%) IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086362|NCT01506271|BG003|Baseline|Total|Total of all reporting groups
11086363|NCT01506271|FG000|Participant Flow|Relebactam 250 mg With Imipenem/Cilastatin|Participants received relebactam 250 mg IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086364|NCT01506271|FG001|Participant Flow|Relebactam 125 mg With Imipenem/Cilastatin|Participants received relebactam 125 mg IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086365|NCT01506271|FG002|Participant Flow|Placebo to Relebactam With Imipenem/Cilastatin|Participants received matching placebo to relebactam (normal saline 0.9%) IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086366|NCT01506271|OG000|Outcome|Relebactam 250 mg With Imipenem/Cilastatin|Participants received relebactam 250 mg IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086367|NCT01506271|OG001|Outcome|Relebactam 125 mg With Imipenem/Cilastatin|Participants received relebactam 125 mg IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086368|NCT01506271|OG002|Outcome|Placebo to Relebactam With Imipenem/Cilastatin|Participants received matching placebo to relebactam (normal saline 0.9%) IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086369|NCT01506271|EG000|Reported Event|Relebactam 250 mg With Imipenem/Cilastatin|Participants received relebactam 250 mg IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086370|NCT01506271|EG001|Reported Event|Relebactam 125 mg With Imipenem/Cilastatin|Participants received relebactam 125 mg IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086371|NCT01506271|EG002|Reported Event|Placebo to Relebactam With Imipenem/Cilastatin|Participants received matching placebo to relebactam (normal saline 0.9%) IV with imipenem/cilastatin 500 mg IV every 6 hours for a minimum of 96 hours
11086372|NCT01506323|BG000|Baseline|Mantram Repetition Program (MRP)|The Mantram Repetition Program (MRP) teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
11086373|NCT01506323|BG001|Baseline|Present Centered Therapy (PCT)|Present Centered Individual Therapy (PCT): The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
11086374|NCT01506323|BG002|Baseline|Total|Total of all reporting groups
11086375|NCT01506323|FG000|Participant Flow|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
11086376|NCT01506323|FG001|Participant Flow|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically avoids actual details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
11086377|NCT01506323|OG000|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
11086378|NCT01506323|OG001|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
11233810|NCT02431260|OG012|Outcome|Part 2 / Treatment Group A: 20 MG BID INCB054329|Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
11233811|NCT02431260|OG013|Outcome|Part 2 / Treatment Group C: 20 mg BID INCB054329|Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
11086379|NCT01506323|OG001|Outcome|Present Centered Therapy (PCT)'|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
11086380|NCT01506323|OG001|Outcome|Present Centered Therapy|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
11086381|NCT01506323|OG000|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
11086382|NCT01506323|OG001|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
11086383|NCT01506323|OG001|Outcome|Present Centered Therapy (PCT)|The PCIT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
11086384|NCT01506323|EG000|Reported Event|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
11086385|NCT01506323|EG001|Reported Event|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
11086386|NCT01506362|BG000|Baseline|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
11086387|NCT01506362|FG000|Participant Flow|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
11086388|NCT01506362|OG000|Outcome|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
11227887|NCT02387502|FG002|Participant Flow|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
11086389|NCT01506362|EG000|Reported Event|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
11086390|NCT01506453|BG000|Baseline|Gabapentin|"Active treatment arm~gabapentin: Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation."
11227888|NCT02387502|OG000|Outcome|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
11086391|NCT01506453|BG001|Baseline|Placebo|"Placebo arm~placebo: Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment."
11086392|NCT01506453|BG002|Baseline|Total|Total of all reporting groups
11086393|NCT01506453|FG000|Participant Flow|Gabapentin|"Active treatment arm.~gabapentin: Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation."
11086394|NCT01506453|FG001|Participant Flow|Placebo|"Placebo arm.~placebo: Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment."
11086395|NCT01506453|OG000|Outcome|Gabapentin|"Active treatment arm.~gabapentin: Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation."
11086396|NCT01506453|OG001|Outcome|Placebo|"Placebo arm.~placebo: Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment."
11086397|NCT01506453|EG000|Reported Event|Gabapentin|"Active treatment arm.~gabapentin: Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation."
11086398|NCT01506453|EG001|Reported Event|Placebo|"Placebo arm.~placebo: Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment."
11086399|NCT01506479|BG000|Baseline|Control Group|"Wait listed to moderate or vigorous exercise after 6 months of no exercise.~No Intervention: No-exercise control (i.e., usual care);"
11086400|NCT01506479|BG001|Baseline|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
11086401|NCT01506479|BG002|Baseline|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
11086402|NCT01506479|BG003|Baseline|Total|Total of all reporting groups
11086403|NCT01506479|FG000|Participant Flow|Control Group|"Wait listed to moderate or vigorous exercise after 6 months of no exercise.~No Intervention: No-exercise control (i.e., usual care);"
11086404|NCT01506479|FG001|Participant Flow|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
11086405|NCT01506479|FG002|Participant Flow|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
11086406|NCT01506479|OG000|Outcome|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
11086407|NCT01506479|OG001|Outcome|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
11086408|NCT01506479|OG000|Outcome|Control Group|"Wait listed to moderate or vigorous exercise after 6 months of no exercise.~No Intervention: No-exercise control (i.e., usual care);"
11086409|NCT01506479|OG001|Outcome|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
11086410|NCT01506479|OG002|Outcome|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
11086411|NCT01506479|EG000|Reported Event|Control Group|"Wait listed to moderate or vigorous exercise after 6 months of no exercise.~No Intervention: No-exercise control (i.e., usual care);"
11086412|NCT01506479|EG001|Reported Event|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
11086413|NCT01506479|EG002|Reported Event|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
11233812|NCT02431260|OG000|Outcome|INCB054329 Monotherapy - 15 mg QD|INCB054329 Monotherapy
11233813|NCT02431260|OG001|Outcome|INCB054329 Monotherapy - 15 mg BID|INCB054329 Monotherapy
11233814|NCT02431260|OG002|Outcome|INCB054329 Monotherapy - 22.5 mg QD|INCB054329 Monotherapy
11233815|NCT02431260|OG003|Outcome|INCB054329 Monotherapy - 30 mg QD|INCB054329 Monotherapy
11086414|NCT01506596|BG000|Baseline|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
11086415|NCT01506596|FG000|Participant Flow|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
11227889|NCT02387502|OG001|Outcome|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
11227890|NCT02387502|OG002|Outcome|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
11227891|NCT02387502|EG000|Reported Event|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
11227892|NCT02387502|EG001|Reported Event|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
11227893|NCT02387502|EG002|Reported Event|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
11227894|NCT02387554|BG000|Baseline|Sequence 1|Period 1 : A Period 2 : L Period 3 : ALC Period 4 : C
11227895|NCT02387554|BG001|Baseline|Sequence 2|Period 1 : L Period 2 : C Period 3 : A Period 4 : ALC
11227896|NCT02387554|BG002|Baseline|Sequence 3|Period 1 : C Period 2 : ALC Period 3 : L Period 4 : A
11227897|NCT02387554|BG003|Baseline|Sequence 4|Period 1 : ALC Period 2 : A Period 3 : C Period 4 : L
11227898|NCT02387554|BG004|Baseline|Total|Total of all reporting groups
11227899|NCT02387554|FG000|Participant Flow|Sequence 1|Period 1 : A (Amlodipine 10mg PO single dose) Period 2 : L (Losartan 100mg PO single dose) Period 3 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 4 : C (Chlorthalidone 25mg PO single dose)
11227900|NCT02387554|FG001|Participant Flow|Sequence 2|Period 1 : L (Losartan 100mg PO single dose) Period 2 : C (Chlorthalidone 25mg PO single dose) Period 3 : A (Amlodipine 10mg PO single dose) Period 4 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose)
11227901|NCT02387554|FG002|Participant Flow|Sequence 3|Period 1 : C (Chlorthalidone 25mg PO single dose) Period 2 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 3 : L (Losartan 100mg PO single dose) Period 4 : A (Amlodipine 10mg PO single dose)
11227902|NCT02387554|FG003|Participant Flow|Sequence 4|Period 1 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 2 : A (Amlodipine 10mg PO single dose) Period 3 : C (Chlorthalidone 25mg PO single dose) Period 4 : L (Losartan 100mg PO single dose)
11227903|NCT02387554|OG000|Outcome|HGP0904|HGP0904(amlodipine) ratio in single or combination
11227904|NCT02387554|OG001|Outcome|HGP0608|HGP0608(losartan) ratio in single or combination
11227905|NCT02387554|OG002|Outcome|HGP1405|HGP1405(chlorthalidone) ratio in single or combination
11227906|NCT02387554|OG003|Outcome|EXP3174|EXP3174(losartan active metabolite) ratio in single or combination
11227907|NCT02387554|EG000|Reported Event|HGP0904|"amlodipine~HGP0904"
11227908|NCT02387554|EG001|Reported Event|HGP0608|"losartan~HGP0608"
11227909|NCT02387554|EG002|Reported Event|HGP1405|"chlorthalidone~HGP1405"
11227910|NCT02387554|EG003|Reported Event|HGP0904+HGP0608+HGP1405|"amlodipine + losartan + chlorthalidone~HGP0904~HGP0608~HGP1405"
11227911|NCT02387580|BG000|Baseline|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11086416|NCT01506596|OG000|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
11086417|NCT01506596|EG000|Reported Event|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
11086418|NCT01506609|BG000|Baseline|Group 1 Placebo + Carboplatin/Paclitaxel|Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086419|NCT01506609|BG001|Baseline|Group 1 Veliparib + Carboplatin/Paclitaxel|Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086420|NCT01506609|BG002|Baseline|Group 1 Veliparib + TMZ|Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
11086421|NCT01506609|BG003|Baseline|Group 2 Placebo + Carboplatin/Paclitaxel|Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086422|NCT01506609|BG004|Baseline|Group 2 Veliparib + Carboplatin/Paclitaxel|Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086423|NCT01506609|BG005|Baseline|Group 2 Veliparib + TMZ|Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
11227912|NCT02387580|BG001|Baseline|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11086424|NCT01506609|BG006|Baseline|Total|Total of all reporting groups
11086425|NCT01506609|FG000|Participant Flow|Group 1 Placebo + Carboplatin/Paclitaxel|Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086426|NCT01506609|FG001|Participant Flow|Group 1 Veliparib + Carboplatin/Paclitaxel|Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086427|NCT01506609|FG002|Participant Flow|Group 1 Veliparib + TMZ|Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
11086428|NCT01506609|FG003|Participant Flow|Group 2 Placebo + Carboplatin/Paclitaxel|Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086429|NCT01506609|FG004|Participant Flow|Group 2 Veliparib + Carboplatin/Paclitaxel|Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086430|NCT01506609|FG005|Participant Flow|Group 2 Veliparib + TMZ|Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
11086431|NCT01506609|OG000|Outcome|Group 2 Placebo + Carboplatin/Paclitaxel|Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086432|NCT01506609|OG001|Outcome|Group 2 Veliparib + Carboplatin/Paclitaxel|Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086433|NCT01506609|OG002|Outcome|Group 2 Veliparib + TMZ|Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
11086434|NCT01506609|EG000|Reported Event|Group 1 Placebo + Carboplatin/Paclitaxel|Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11233816|NCT02431260|OG004|Outcome|INCB054329 Monotherapy - 20 mg BID|INCB054329 Monotherapy
11086435|NCT01506609|EG001|Reported Event|Group 1 Veliparib + Carboplatin/Paclitaxel|Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086436|NCT01506609|EG002|Reported Event|Group 1 Veliparib + TMZ|Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
11086437|NCT01506609|EG003|Reported Event|Group 2 Placebo + Carboplatin/Paclitaxel|Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086438|NCT01506609|EG004|Reported Event|Group 2 Veliparib + Carboplatin/Paclitaxel|Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
11086439|NCT01506609|EG005|Reported Event|Group 2 Veliparib + TMZ|Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
11086440|NCT01506726|BG000|Baseline|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
11086441|NCT01506726|BG001|Baseline|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
11086442|NCT01506726|BG002|Baseline|Total|Total of all reporting groups
11086443|NCT01506726|FG000|Participant Flow|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
11086444|NCT01506726|FG001|Participant Flow|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
11086445|NCT01506726|OG000|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
11086446|NCT01506726|OG001|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
11086447|NCT01506726|EG000|Reported Event|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
11086448|NCT01506726|EG001|Reported Event|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
11086449|NCT01506882|BG000|Baseline|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
11086450|NCT01506882|BG001|Baseline|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
11086451|NCT01506882|BG002|Baseline|Total Title|
11086452|NCT01506882|FG000|Participant Flow|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
11086453|NCT01506882|FG001|Participant Flow|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
11086454|NCT01506882|OG000|Outcome|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
11086455|NCT01506882|OG000|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
11086456|NCT01506882|OG000|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
11086457|NCT01506882|OG000|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
11086458|NCT01506882|EG000|Reported Event|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
11086459|NCT01506882|EG001|Reported Event|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
11086460|NCT01506908|BG000|Baseline|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
11227913|NCT02387580|BG002|Baseline|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227914|NCT02387580|BG003|Baseline|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11233817|NCT02431260|OG005|Outcome|INCB054329 Monotherapy - 22.5 mg BID|INCB054329 Monotherapy
11086461|NCT01506908|BG001|Baseline|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
11086462|NCT01506908|BG002|Baseline|Total|Total of all reporting groups
11086463|NCT01506908|FG000|Participant Flow|Nicotine Lozenge 4 Milligrams (mg)|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
11086464|NCT01506908|FG001|Participant Flow|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
11086465|NCT01506908|OG000|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
11086466|NCT01506908|OG001|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
11086467|NCT01506908|OG000|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
11086468|NCT01506908|OG001|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
11086469|NCT01506908|EG000|Reported Event|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
11086470|NCT01506908|EG001|Reported Event|Placebo Lozenge|Participants received a single dose of matched placebo mint lozenge, through oral route.
11086471|NCT01506947|BG000|Baseline|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
11086472|NCT01506947|FG000|Participant Flow|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
11086473|NCT01506947|OG000|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
11227915|NCT02387580|BG004|Baseline|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11086474|NCT01506947|OG000|Outcome|Baseline|
11086475|NCT01506947|OG001|Outcome|Month 6|
11086476|NCT01506947|EG000|Reported Event|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
11086477|NCT01506960|BG000|Baseline|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
11086478|NCT01506960|FG000|Participant Flow|Coronary Stenting With OCT, NIRS/IVUS|All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
11086479|NCT01506960|OG000|Outcome|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
11086480|NCT01506960|OG000|Outcome|Superficial Lipid|
11086481|NCT01506960|OG001|Outcome|Deep Lipid|
11086482|NCT01506960|EG000|Reported Event|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
11086483|NCT01507051|BG000|Baseline|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
11086484|NCT01507051|BG001|Baseline|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
11086485|NCT01507051|BG002|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
11086486|NCT01507051|BG003|Baseline|Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
11227916|NCT02387580|BG005|Baseline|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
11086487|NCT01507051|BG004|Baseline|Total|Total of all reporting groups
11086488|NCT01507051|FG000|Participant Flow|Group A: Warfarin Followed by Rivaroxaban|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
11086489|NCT01507051|FG001|Participant Flow|Group B: Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
11086490|NCT01507051|FG002|Participant Flow|Group C: Rivaroxaban Without Any Pre-treatment With Warfarin|Days 0 to 3: 20 mg rivaroxaban once daily
11086491|NCT01507051|FG003|Participant Flow|Group D: Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
11086492|NCT01507051|OG000|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
11086493|NCT01507051|OG001|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
11086494|NCT01507051|OG002|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
11086495|NCT01507051|OG001|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
11086496|NCT01507051|EG000|Reported Event|RG1: Warfarin Followed by Rivaroxaban|All participants received warfarin and later rivaroxaban. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group A of the Participant Flow section.
11086497|NCT01507051|EG001|Reported Event|RG2: Warfarin Followed by Placebo|All participants received warfarin and later placebo. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group B of the Participant Flow section.
11086498|NCT01507051|EG002|Reported Event|RG3: Rivaroxaban|All participants received rivaroxaban. Days 0 to 3: 20 mg rivaroxaban once daily. Note: Safety Data presented here include participants listed in Group C of the Participant Flow section.
11086499|NCT01507051|EG003|Reported Event|RG4: Warfarin Alone|All participants received warfarin in the Run-In Phase, who either received rivaroxaban or placebo afterwards, or discontinued the study. Days -6 to -1(could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR. Note: Safety Data presented here include participants listed in Groups A, B (warfarin run-in only) and D of the Participant Flow section.
11086500|NCT01507090|BG000|Baseline|Normal Children|Otherwise healthy children 2 months to 16 years of age.
11086501|NCT01507090|FG000|Participant Flow|Normal Children|Otherwise healthy children 2 months to 16 years of age were enrolled. The 2D and 3D Mercy TAPE was developed to measure two upper arm landmarks so as to arrive at the weight estimate for a given child. The 2D Mercy TAPE requires two serial measurements with simple addition. The 3D TAPE makes both measurements simultaneously also requiring simple addition.
11086502|NCT01507090|OG000|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
11086503|NCT01507090|OG001|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
11086504|NCT01507090|OG000|Outcome|2D-TAPE|Study coordinators performing measurements
11086505|NCT01507090|OG001|Outcome|3D-TAPE|Study coordinators performing measurements
11086506|NCT01507090|OG002|Outcome|Mercy Method|Study coordinators performing measurements
11086507|NCT01507090|OG000|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
11086508|NCT01507090|EG000|Reported Event|Normal Children|Otherwise healthy children 2 months to 16 years of age.
11227917|NCT02387580|BG006|Baseline|Total|Total of all reporting groups
11086509|NCT01507103|BG000|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
11086510|NCT01507103|BG001|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
11086511|NCT01507103|BG002|Baseline|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
11086512|NCT01507103|BG003|Baseline|Total|Total of all reporting groups
11086513|NCT01507103|FG000|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
11086514|NCT01507103|FG001|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
11086515|NCT01507103|FG002|Participant Flow|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
11086516|NCT01507103|OG000|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
11086517|NCT01507103|OG001|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
11086518|NCT01507103|OG002|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
11227918|NCT02387580|FG000|Participant Flow|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227919|NCT02387580|FG001|Participant Flow|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227920|NCT02387580|FG002|Participant Flow|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227921|NCT02387580|FG003|Participant Flow|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11086519|NCT01507103|EG000|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
11086520|NCT01507103|EG001|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
11086521|NCT01507103|EG002|Reported Event|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
11086522|NCT01507155|BG000|Baseline|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
11086523|NCT01507155|FG000|Participant Flow|Clincian-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
11086524|NCT01507155|FG001|Participant Flow|Patient-Reported Measures|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
11086525|NCT01507155|OG000|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
11086526|NCT01507155|EG000|Reported Event|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
11086527|NCT01507155|EG001|Reported Event|Patient-Reported Outcomes|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
11227922|NCT02387580|FG004|Participant Flow|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227923|NCT02387580|FG005|Participant Flow|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227924|NCT02387580|OG000|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227925|NCT02387580|OG001|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11086528|NCT01507181|BG000|Baseline|Ketamine|single dose IV ketamine, .5mg/kg
11086529|NCT01507181|BG001|Baseline|Midazolam|single dose IV midazolam, .45mg/kg
11086530|NCT01507181|BG002|Baseline|Total|Total of all reporting groups
11086531|NCT01507181|FG000|Participant Flow|Ketamine|"single dose IV ketamine, .5mg/kg~Ketamine: single dose IV ketamine, .5mg/kg infused over 40 minutes"
11086532|NCT01507181|FG001|Participant Flow|Midazolam|"single dose IV midazolam, .45mg/kg~Midazolam: single dose IV midazolam, .45mg/kg infused over 40 minutes"
11086533|NCT01507181|OG000|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
11086534|NCT01507181|OG001|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
11086535|NCT01507181|EG000|Reported Event|Ketamine|single dose IV ketamine, .5mg/kg
11086536|NCT01507181|EG001|Reported Event|Midazolam|single dose IV midazolam, .45mg/kg
11227926|NCT02387580|OG002|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227927|NCT02387580|OG003|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227928|NCT02387580|OG004|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227929|NCT02387580|OG005|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
11227930|NCT02387580|OG004|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227931|NCT02387580|OG005|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227932|NCT02387580|EG000|Reported Event|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227933|NCT02387580|EG001|Reported Event|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227934|NCT02387580|EG002|Reported Event|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11233818|NCT02431260|OG006|Outcome|INCB054329 Monotherapy - 25 mg BID|INCB054329 Monotherapy
11086537|NCT01507220|BG000|Baseline|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
11086538|NCT01507220|BG001|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
11086539|NCT01507220|BG002|Baseline|Total|Total of all reporting groups
11086540|NCT01507220|FG000|Participant Flow|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
11086541|NCT01507220|FG001|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
11227935|NCT02387580|EG003|Reported Event|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227936|NCT02387580|EG004|Reported Event|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227937|NCT02387580|EG005|Reported Event|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
11227938|NCT02387710|BG000|Baseline|All Analyzed Participants|All patients who were randomized, completed both study nights and were included in the analysis
11227939|NCT02387710|FG000|Participant Flow|Tiagabine First, Placebo Second|Tiagabine 12 mg administered at normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching tiagabine administered at normal sleep time on second study night.
11086542|NCT01507220|OG000|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
11086543|NCT01507220|OG001|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
11227940|NCT02387710|FG001|Participant Flow|Placebo First, Tiagabine Second|Placebo-matching tiagabine administered at normal sleep timeon first study night, then a 1-week non-treatment, then tiagabine 12 mg administered at normal sleep time on second study night
11227941|NCT02387710|OG000|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
11227942|NCT02387710|OG001|Outcome|Placebo|Placebo administered at sleep time on the first or second study night
11227943|NCT02387710|OG000|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or the second study night
11227944|NCT02387710|OG001|Outcome|Placebo|Placebo administered at sleep time on the first or the second study night
11227945|NCT02387710|EG000|Reported Event|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
11227946|NCT02387710|EG001|Reported Event|Placebo|Placebo administered at sleep time on the first or second study night
11227947|NCT02387749|BG000|Baseline|Mesenchymal Stem Cells Transfusion in DPN Patients|This study was conducted on 10 patients with Diabetic peripheral neuropathy (DPN), 4 females and 6 males
11227948|NCT02387749|FG000|Participant Flow|Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy|collection: bone marrow biopsy from iliac crest. Separation of cells:The bone marrow aspirate will be diluted at a ratio of 6:1 with phosphate buffer saline (PBS) with 2 ml EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer). The MNCs will be separated under aseptic conditions using a Ficoll. Hypaque desity gradient by centrifugation at 1800 rpm for 20 min then the MNCs will be plated in 40 ml alpha-modi-field Eagle's medium (αMEM), serum free media; mesencult(Mesenchymal stem cell culture),penicillin (100 U/ml),streptomycin(10 mg/ml),0.5 ml amphotericin B(all from Gibco BRL) and 10 ng/ml basic fibroblast growth factor (b-FGF) (R&D system, Minneapolis, MN) and will be incubated at 37 c in a humidified atmosphere containing 5% CO2.after one day,non adherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every 1 week. After reaching 80% confluence the MSCs will be placed in 10 ml saline and will be infused intravenously. on 2 sessions to the same patient
11227949|NCT02387749|OG000|Outcome|Measurement of b-FGF and v- EGF MEASURED BY ELISA|measurement of b-FGF and v- EGF MEASURED BY ELISA before (at zero), and after at (7 days, 90) days after stem cell transfusion to measure the effect of stem cell and its role in nerve regeneration
11233819|NCT02431260|OG007|Outcome|INCB054329 Monotherapy - Overall Dosing Regimen|INCB054329 Monotherapy
11233820|NCT02431260|OG002|Outcome|INCB054329 Monotherapy - 22.5 mg BID|INCB054329 Monotherapy
11086544|NCT01507220|EG000|Reported Event|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
11086545|NCT01507220|EG001|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
11086546|NCT01507246|BG000|Baseline|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
11086547|NCT01507246|BG001|Baseline|EXPAREL Group|Group receiving EXPAREL
11086548|NCT01507246|BG002|Baseline|Total|Total of all reporting groups
11086549|NCT01507246|FG000|Participant Flow|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
11086550|NCT01507246|FG001|Participant Flow|EXPAREL Group|Group receiving EXPAREL
11086551|NCT01507246|OG000|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
11227950|NCT02387749|OG000|Outcome|Nerve Conduction Velocities of Nerves|"nerve conduction velocities of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory~lower limb motor nerves: tibial and common peroneal lower limb sensory nerve : sural nerve~upper limb motor nerve: ulnar nerve upper limb sensory nerve: ulnar nerve~data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion"
11086552|NCT01507246|OG001|Outcome|EXPAREL|Group receiving EXPAREL
11086553|NCT01507246|OG000|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
11086554|NCT01507246|OG000|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
11086555|NCT01507246|OG001|Outcome|EXPAREL Group|Group receiving EXPAREL
11086556|NCT01507246|EG000|Reported Event|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
11086557|NCT01507246|EG001|Reported Event|EXPAREL Group|Group receiving EXPAREL
11086558|NCT01507298|BG000|Baseline|Capsule Endoscopy|A pill camera used for imaging the small bowel
11086559|NCT01507298|BG001|Baseline|24 Hour Oesophageal pH Study|Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
11086560|NCT01507298|BG002|Baseline|Total|Total of all reporting groups
11086561|NCT01507298|FG000|Participant Flow|Capsule Endoscopy|A pill camera used for imaging the small bowel
11086562|NCT01507298|FG001|Participant Flow|24 Hour Oesophageal pH Study|Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
11086563|NCT01507298|OG000|Outcome|Capsule Endoscopy|A pill camera used for imaging the small bowel.
11086564|NCT01507298|OG001|Outcome|24 Hour Oesophageal pH Study|Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
11086565|NCT01507298|OG000|Outcome|Capsule Endoscopy|A pill camera used for imaging the small bowel
11086566|NCT01507298|EG000|Reported Event|Capsule Endoscopy|A pill camera used to image the small bowel.
11086567|NCT01507298|EG001|Reported Event|24 Hour Oesophageal pH Study|Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
11086568|NCT01507350|BG000|Baseline|Obesity Surgery|Patients having gastric band, sleeve gastrectomy, and gastric bypass will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months.
11086569|NCT01507350|FG000|Participant Flow|Obesity Surgery|Patients having gastric band, sleeve gastrectomy, and gastric bypass will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months.
11086570|NCT01507350|OG000|Outcome|Obesity Surgery|Patients having gastric band, sleeve gastrectomy, and gastric bypass will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months.
11086571|NCT01507350|EG000|Reported Event|Obesity Surgery|Patients having gastric band, sleeve gastrectomy, and gastric bypass will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months.
11086572|NCT01507493|BG000|Baseline|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
11086573|NCT01507493|BG001|Baseline|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
11086574|NCT01507493|BG002|Baseline|Total|Total of all reporting groups
11086575|NCT01507493|FG000|Participant Flow|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
11086576|NCT01507493|FG001|Participant Flow|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
11086577|NCT01507493|OG000|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
11086578|NCT01507493|OG001|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
11086579|NCT01507493|EG000|Reported Event|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
11086580|NCT01507493|EG001|Reported Event|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
11233821|NCT02431260|OG005|Outcome|INCB054329 Monotherapy - 22.5 mg QD|INCB054329 Monotherapy
11086581|NCT01507662|BG000|Baseline|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
11086582|NCT01507662|BG001|Baseline|Control|Usual care
11086583|NCT01507662|BG002|Baseline|Total|Total of all reporting groups
11086584|NCT01507662|FG000|Participant Flow|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
11086585|NCT01507662|FG001|Participant Flow|Control|Usual care
11086586|NCT01507662|OG000|Outcome|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
11086587|NCT01507662|OG001|Outcome|Control|Usual care
11086588|NCT01507662|EG000|Reported Event|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
11086589|NCT01507662|EG001|Reported Event|Control|Usual care
11227951|NCT02387749|OG000|Outcome|Nerve Conduction Latency of Nerves|nerve conduction latency of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory lower limb motor nerves: tibial and common peroneal lower limb sensory nerve : sural nerve upper limb motor nerve: ulnar nerve upper limb sensory nerve: ulnar nerve data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion
11086590|NCT01507688|BG000|Baseline|SSM Intervention Arm 1|"Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.~Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6."
11086591|NCT01507688|BG001|Baseline|Usual Care Arm 2|Usual care which includes standardized patient education materials on stroke from the American Stroke Association.
11086592|NCT01507688|BG002|Baseline|Total|Total of all reporting groups
11086593|NCT01507688|FG000|Participant Flow|Arm 1 SSM Intervention|"Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.~Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6."
11086594|NCT01507688|FG001|Participant Flow|Arm 2 Usual Care|Usual care for treating a patient presenting with an acute ischemic stroke or TIA
11086595|NCT01507688|OG000|Outcome|Arm 1 SSM Intervention|"Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.~Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6."
11086596|NCT01507688|OG001|Outcome|Arm 2 Usual Care|Usual care for acute stroke care services
11086597|NCT01507688|EG000|Reported Event|Arm 1 SSM Intervention|"Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.~Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6."
11086598|NCT01507688|EG001|Reported Event|Arm 2 Usual Care|Usual care for acute ischemic stroke
11086599|NCT01507779|BG000|Baseline|Influenza Vaccine|"Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21~IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials."
11086600|NCT01507779|BG001|Baseline|Placebo|"Received placebo, administered intramuscularly, on days 0 and 21~Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials."
11086601|NCT01507779|BG002|Baseline|Total|Total of all reporting groups
11086602|NCT01507779|FG000|Participant Flow|Influenza Vaccine|"Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21~IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials."
11086603|NCT01507779|FG001|Participant Flow|Placebo|"Received placebo, administered intramuscularly, on days 0 and 21~Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials."
11086604|NCT01507779|OG000|Outcome|Placebo|"Received placebo, administered intramuscularly, on days 0 and 21~Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials."
11086605|NCT01507779|OG001|Outcome|Influenza Vaccine|"Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21~IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials."
11086606|NCT01507779|OG000|Outcome|Influenza Vaccine|"Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21~IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials."
11086607|NCT01507779|OG001|Outcome|Placebo|"Received placebo, administered intramuscularly, on days 0 and 21~Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials."
11086608|NCT01507779|EG000|Reported Event|Influenza Vaccine|"Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21~IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials."
11086609|NCT01507779|EG001|Reported Event|Placebo|"Received placebo, administered intramuscularly, on days 0 and 21~Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials."
11086610|NCT01507831|BG000|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
11086611|NCT01507831|BG001|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
11227952|NCT02387749|OG000|Outcome|Nerve Conduction Amplitudes of Nerves|"nerve conduction amplitudes of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory lower limb motor nerves: tibial and common peroneal, lower limb sensory nerve : sural nerve.~upper limb motor nerve: ulnar nerve motor , upper limb sensory nerve: ulnar nerve sensory data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion"
11227953|NCT02387749|OG000|Outcome|Blood Tests Measured Before and After Stem Cell Transfusion|Plasma biochemical blood measurements will be determined by standard laboratory procedures in the central lab at clinical pathology department, Kasr Alaini hospital) Fasting blood glucose level, 2 hours postprandial.
11227954|NCT02387749|OG000|Outcome|HA1C Measurment Before and Afterr Stem Cell|as a cumulative effect of patient control we measured HA1C at zero level and 90 days after stem cell transfusion in %
11086612|NCT01507831|BG002|Baseline|Total|Total of all reporting groups
11086613|NCT01507831|FG000|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid modifying therapy (LMT) for 78 weeks.
11086614|NCT01507831|FG001|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
11086615|NCT01507831|OG000|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
11086616|NCT01507831|OG001|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
11086617|NCT01507831|EG000|Reported Event|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
11086618|NCT01507831|EG001|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
11086619|NCT01507896|BG000|Baseline|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
11086620|NCT01507896|FG000|Participant Flow|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
11086621|NCT01507896|OG000|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
11086622|NCT01507896|OG001|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
11086623|NCT01507896|OG002|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
11086624|NCT01507896|OG002|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
11086625|NCT01507896|OG000|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient com fort. It generally referred to major orthopedic (e.g., joint replacement), major abdom inal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatom ical space. Several tooth extractions or extraction of the third molar were generally considered as major.
11086626|NCT01507896|OG000|Outcome|All Surgical Procedures|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
11086627|NCT01507896|OG000|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
11086628|NCT01507896|OG001|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth Minor surgeries.
11086629|NCT01507896|OG000|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
11086630|NCT01507896|OG000|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
11086631|NCT01507896|EG000|Reported Event|All Participants|All unique participants treated with BAX326 per planned surgical procedure.
11086632|NCT01507987|BG000|Baseline|All Subjects Enrolled in the Study|Demographics for all enrolled patients (N=2216)
11227955|NCT02387749|EG000|Reported Event|Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy|collection: bone marrow biopsy from iliac crest. Separation of cells:The bone marrow aspirate will be diluted at a ratio of 6:1 with phosphate buffer saline (PBS) with 2 ml EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer). The MNCs will be separated under aseptic conditions using a Ficoll. Hypaque desity gradient by centrifugation at 1800 rpm for 20 min then the MNCs will be plated in 40 ml alpha-modi-field Eagle's medium (αMEM), serum free media; mesencult(Mesenchymal stem cell culture),penicillin (100 U/ml),streptomycin(10 mg/ml),0.5 ml amphotericin B(all from Gibco BRL) and 10 ng/ml basic fibroblast growth factor (b-FGF) (R&D system, Minneapolis, MN) and will be incubated at 37 c in a humidified atmosphere containing 5% CO2.after one day,non adherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every 1 week. After reaching 80% confluence the MSCs will be placed in 10 ml saline and will be infused intravenously. on 2 sessions to the same patient
11086633|NCT01507987|FG000|Participant Flow|Durata Leads|Durata leads implanted between 2008-2010
11086634|NCT01507987|FG001|Participant Flow|Riata Leads|Riata leads implanted between 2002-2009
11086635|NCT01507987|FG002|Participant Flow|Riata ST|Riata ST leads implanted 2006-2009
11086636|NCT01507987|FG003|Participant Flow|QuickSite/QuickFlex|QuickSite/QuickFlex implanted 2006-2010
11086637|NCT01507987|OG000|Outcome|Durata Leads|Durata leads implanted between 2008-2010
11086638|NCT01507987|OG001|Outcome|Riata Leads|Riata leads implanted between 2002-2009
11086639|NCT01507987|OG002|Outcome|Riata ST|Riata ST leads implanted 2006-2009
11086640|NCT01507987|OG003|Outcome|QuickSite/QuickFlex|QuickSite/QuickFlex implanted 2006-2010
11086641|NCT01507987|OG000|Outcome|Durata Leads Lead Age: Less Than 4 Years|lead age: less than 4 years
11086642|NCT01507987|OG001|Outcome|Durata Leads Lead Age: 4 to Less Than 5 Years|lead age: 4 to less than 5 years
11086643|NCT01507987|OG002|Outcome|Durata Leads Lead Age: 5 Years or Greater|lead age: 5 years or greater
11086644|NCT01507987|OG003|Outcome|Riata Leads Lead Age: Less Than 6 Years|lead age: less than 6 years
11086645|NCT01507987|OG004|Outcome|Riata Leads Lead Age: 6-less Than 7 Years|lead age: 6-less than 7 years
11086646|NCT01507987|OG005|Outcome|Riata Leads Lead Age: 7 Years or Greater|lead age: 7 years or greater
11086647|NCT01507987|OG006|Outcome|Riata ST Lead Age: Less Than 5.5 Years|lead age: less than 5.5 years
11086648|NCT01507987|OG007|Outcome|Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years|lead age: greater than or equal to 5.5 years
11086649|NCT01507987|OG008|Outcome|QuickSite/QuickFlex Lead Age: Less Than 5 Years|lead age: less than 5 years
11086650|NCT01507987|OG009|Outcome|QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years|lead age: 5 to less than 6 years
11086651|NCT01507987|OG010|Outcome|QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years|lead age: greater than or equal to 6 years
11086652|NCT01507987|OG002|Outcome|Riata ST Leads|Riata ST leads implanted between 2006-2009
11086653|NCT01507987|OG003|Outcome|QuickSite/QuickFlex Leads|Quicksite or QuickFlex leads implanted between 2006-2010
11086654|NCT01507987|OG000|Outcome|With Externalized Conductors (EC)|EC identified
11086655|NCT01507987|OG001|Outcome|Without Externalized Conductors (EC)|No EC identified
11086656|NCT01507987|OG000|Outcome|With Electrical Dysfunction (ED)|ED identified
11086657|NCT01507987|OG001|Outcome|Without Electrical Dysfunction (ED)|No ED identified
11086658|NCT01507987|EG000|Reported Event|Durata Leads|Subjects implanted with SJM Durata leads
11086659|NCT01507987|EG001|Reported Event|Riata Leads|Subjects implanted with Riata leads
11086660|NCT01507987|EG002|Reported Event|Riata ST Leads|Subjects implanted with Riata ST leads
11086661|NCT01507987|EG003|Reported Event|QuickSite/QuickFlex Leads|Subjects implanted with QuickSite/QuickFlex leads
11086662|NCT01508013|BG000|Baseline|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
11086663|NCT01508013|BG001|Baseline|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
11086664|NCT01508013|BG002|Baseline|Total|Total of all reporting groups
11086665|NCT01508013|FG000|Participant Flow|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
11086666|NCT01508013|FG001|Participant Flow|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
11086667|NCT01508013|OG000|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
11227956|NCT02387762|BG000|Baseline|ACP-196 + Methotrexate|Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
11086668|NCT01508013|OG001|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
11086669|NCT01508013|EG000|Reported Event|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
11086670|NCT01508013|EG001|Reported Event|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
11086671|NCT01508052|BG000|Baseline|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
11086672|NCT01508052|BG001|Baseline|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
11086673|NCT01508052|BG002|Baseline|Total|Total of all reporting groups
11086674|NCT01508052|FG000|Participant Flow|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
11086675|NCT01508052|FG001|Participant Flow|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
11086676|NCT01508052|OG000|Outcome|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
11086677|NCT01508052|OG001|Outcome|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
11086678|NCT01508052|EG000|Reported Event|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
11086679|NCT01508052|EG001|Reported Event|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
11086680|NCT01508117|BG000|Baseline|Axitinib + Radiation Therapy|"Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity~Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity~Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy"
11086681|NCT01508117|FG000|Participant Flow|Axitinib + Radiation Therapy|"Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity~Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity~Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy"
11227957|NCT02387762|BG001|Baseline|Placebo + Methotrexate|Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
11227958|NCT02387762|BG002|Baseline|Total|Total of all reporting groups
11227959|NCT02387762|FG000|Participant Flow|ACP-196 + Methotrexate|Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
11227960|NCT02387762|FG001|Participant Flow|Placebo + Methotrexate|Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
11086682|NCT01508117|OG000|Outcome|Axitinib + Radiation Therapy|"Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity~Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity~Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy"
11086683|NCT01508117|EG000|Reported Event|Axitinib + Radiation Therapy|"Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity~Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity~Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy"
11086684|NCT01508130|BG000|Baseline|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
11086685|NCT01508130|BG001|Baseline|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
11086686|NCT01508130|BG002|Baseline|Total|Total of all reporting groups
11086687|NCT01508130|FG000|Participant Flow|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received PegIFN + RBV + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
11086688|NCT01508130|FG001|Participant Flow|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
11086689|NCT01508130|OG000|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
11086690|NCT01508130|OG001|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
11227961|NCT02387762|OG000|Outcome|ACP 196 + Methotrexate|Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
11086691|NCT01508130|OG000|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
11086692|NCT01508130|OG000|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
11086693|NCT01508130|EG000|Reported Event|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
11086694|NCT01508130|EG001|Reported Event|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
11086695|NCT01508169|BG000|Baseline|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086696|NCT01508169|BG001|Baseline|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086697|NCT01508169|BG002|Baseline|Total|Total of all reporting groups
11086698|NCT01508169|FG000|Participant Flow|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11227962|NCT02387762|OG001|Outcome|Placebo + Methotrexate|Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
11227963|NCT02387762|EG000|Reported Event|ACP-196 + Methotrexate|Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
11227964|NCT02387762|EG001|Reported Event|Placebo + Methotrexate|Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
11086699|NCT01508169|FG001|Participant Flow|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086700|NCT01508169|OG000|Outcome|Foot Orthosis|Fourty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086701|NCT01508169|OG001|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects complited the protocolBalance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086702|NCT01508169|OG000|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086703|NCT01508169|OG001|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086704|NCT01508169|OG000|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086705|NCT01508169|OG001|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086706|NCT01508169|OG000|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086707|NCT01508169|OG001|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086708|NCT01508169|EG000|Reported Event|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086709|NCT01508169|EG001|Reported Event|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
11086710|NCT01508325|BG000|Baseline|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
11086711|NCT01508325|BG001|Baseline|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
11086712|NCT01508325|BG002|Baseline|Total|Total of all reporting groups
11086713|NCT01508325|FG000|Participant Flow|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks.
11086714|NCT01508325|FG001|Participant Flow|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
11086715|NCT01508325|OG000|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
11086716|NCT01508325|OG001|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
11086717|NCT01508325|EG000|Reported Event|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
11086718|NCT01508325|EG001|Reported Event|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
11086719|NCT01508455|BG000|Baseline|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
11086720|NCT01508455|FG000|Participant Flow|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
11086721|NCT01508455|OG000|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
11086722|NCT01508455|EG000|Reported Event|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
11086723|NCT01508650|BG000|Baseline|No Intervention|Usual care control group
11086724|NCT01508650|BG001|Baseline|Active Comparator|Multi domain rehabilitation intervention
11086725|NCT01508650|BG002|Baseline|Total|Total of all reporting groups
11086726|NCT01508650|FG000|Participant Flow|No Intervention|Usual care control group
11086727|NCT01508650|FG001|Participant Flow|Active Comparator|Multi domain rehabilitation intervention
11086728|NCT01508650|OG000|Outcome|No Intervention|Usual care control group
11086729|NCT01508650|OG001|Outcome|Active Comparator|Multi domain rehabilitation intervention
11227965|NCT02387801|BG000|Baseline|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
11086730|NCT01508650|EG000|Reported Event|No Intervention|Usual care control group
11086731|NCT01508650|EG001|Reported Event|Active Comparator|Multi domain rehabilitation intervention
11086732|NCT01508676|BG000|Baseline|Pennsaid Phase I|Pennsaid (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
11086733|NCT01508676|BG001|Baseline|Placebo Phase I|Placebo lotion (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
11086734|NCT01508676|BG002|Baseline|Total|Total of all reporting groups
11086735|NCT01508676|FG000|Participant Flow|Pennsaid Phase I, Placebo Phase II|"Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).~Washout: 1 week, applying nothing.~Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily)."
11086736|NCT01508676|FG001|Participant Flow|Placebo Phase I, Pennsaid Phase II|"Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).~Washout: 1 week, applying nothing.~Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily)."
11086737|NCT01508676|OG000|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
11086738|NCT01508676|OG001|Outcome|Placebo|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
11086739|NCT01508676|OG001|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
11086740|NCT01508676|EG000|Reported Event|Pennsaid|Pennsaid (20-40 drops; 2-4 times daily for 2 weeks).
11086741|NCT01508676|EG001|Reported Event|Placebo|Placebo lotion (20-40 drops; 2-4 times daily for 2 weeks).
11086742|NCT01508702|BG000|Baseline|Lesinurad 400 mg|lesinurad 400 mg
11086743|NCT01508702|BG001|Baseline|Placebo|
11086744|NCT01508702|BG002|Baseline|Total|Total of all reporting groups
11086745|NCT01508702|FG000|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg
11086746|NCT01508702|FG001|Participant Flow|Placebo|
11086747|NCT01508702|OG000|Outcome|Lesinurad 400 mg|lesinurad 400 mg
11086748|NCT01508702|OG001|Outcome|Placebo|Placebo qd
11086749|NCT01508702|EG000|Reported Event|Lesinurad 400 mg|lesinurad 400 mg
11086750|NCT01508702|EG001|Reported Event|Placebo|
11086751|NCT01508832|BG000|Baseline|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger
11086752|NCT01508832|BG001|Baseline|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger.
11086753|NCT01508832|BG002|Baseline|Total|Total of all reporting groups
11086754|NCT01508832|FG000|Participant Flow|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger.
11086755|NCT01508832|FG001|Participant Flow|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger.
11086756|NCT01508832|OG000|Outcome|Lidocaine|Lidocaine 1% digital nerve block (2cc) in one finger
11086757|NCT01508832|OG001|Outcome|Bupivacaine|Bupivacaine 0.25% digital nerve block (2cc) in one finger
11086758|NCT01508832|EG000|Reported Event|Lidocaine|Lidocaine digital block in right or left finger
11086759|NCT01508832|EG001|Reported Event|Bupivacaine|Bupivacaine digital block right or left finger
11227966|NCT02387801|BG001|Baseline|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
11086760|NCT01508910|BG000|Baseline|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
11086761|NCT01508910|BG001|Baseline|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
11086762|NCT01508910|BG002|Baseline|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
11086763|NCT01508910|BG003|Baseline|Total|Total of all reporting groups
11086764|NCT01508910|FG000|Participant Flow|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
11086765|NCT01508910|FG001|Participant Flow|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
11086766|NCT01508910|FG002|Participant Flow|Unblinded Standard of Care (SOC) Arm|No study-related procedures were performed.
11086767|NCT01508910|FG003|Participant Flow|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
11086768|NCT01508910|OG000|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
11086769|NCT01508910|OG001|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
11086770|NCT01508910|OG000|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
11086771|NCT01508910|OG001|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis.
11086772|NCT01508910|OG002|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
11086773|NCT01508910|OG003|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
11086774|NCT01508910|EG000|Reported Event|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
11086775|NCT01508910|EG001|Reported Event|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
11086776|NCT01508910|EG002|Reported Event|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
11086777|NCT01508910|EG003|Reported Event|Not Treated Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
11086778|NCT01508936|BG000|Baseline|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
11086779|NCT01508936|BG001|Baseline|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
11086780|NCT01508936|BG002|Baseline|Total|Total of all reporting groups
11086781|NCT01508936|FG000|Participant Flow|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
11086782|NCT01508936|FG001|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
11086783|NCT01508936|OG000|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
11086784|NCT01508936|OG001|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
11086785|NCT01508936|EG000|Reported Event|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
11086786|NCT01508936|EG001|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
11227967|NCT02387801|BG002|Baseline|Total|Total of all reporting groups
11227968|NCT02387801|FG000|Participant Flow|Ixekizumab Q2W|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
11227969|NCT02387801|FG001|Participant Flow|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
11086787|NCT01509040|BG000|Baseline|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
11086788|NCT01509040|BG001|Baseline|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
11086789|NCT01509040|BG002|Baseline|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
11086790|NCT01509040|BG003|Baseline|Total|Total of all reporting groups
11086791|NCT01509040|FG000|Participant Flow|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
11086792|NCT01509040|FG001|Participant Flow|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
11086793|NCT01509040|FG002|Participant Flow|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
11086794|NCT01509040|OG000|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
11173713|NCT02017093|OG000|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
11227970|NCT02387801|OG000|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
11086795|NCT01509040|OG001|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
11086796|NCT01509040|OG002|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
11086797|NCT01509040|OG000|Outcome|Control|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques.~Percutaneous coronary intervention performed as"
11086798|NCT01509040|OG001|Outcome|Low Volume Hemofiltration|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core tem"
11086799|NCT01509040|OG002|Outcome|High Volume Hemofiltration|"Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core"
11086800|NCT01509040|OG000|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
11227971|NCT02387801|OG001|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
11092123|NCT01537419|BG000|Baseline|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
11227972|NCT02387801|EG000|Reported Event|Ixekizumab Q2W Induction Dosing Period|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
11227973|NCT02387801|EG001|Reported Event|Ixekizumab Q4W Induction Dosing Period|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
11227974|NCT02387801|EG002|Reported Event|Ixekizumab 80 mg Q4W Maintenance|After week 12 all participants are given 80 mg ixekizumab as a single SC injection once Q4W through week 44.
11086801|NCT01509040|OG001|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
11086802|NCT01509040|OG002|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
11086803|NCT01509040|OG002|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
11086804|NCT01509040|EG000|Reported Event|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
11086805|NCT01509040|EG001|Reported Event|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
11086806|NCT01509040|EG002|Reported Event|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
11227975|NCT02387801|EG003|Reported Event|Ixekizumab 80 mg Q4W Post-treatment|All participants receiving at least one dose of ixekizumab entered the post treatment follow-up period for a minimum of 12 weeks.
11227976|NCT02387814|BG000|Baseline|Abemaciclib: Normal Hepatic Function|200 mg abemaciclib administered once, orally, to participants with normal hepatic function.
11086807|NCT01509079|BG000|Baseline|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
11086808|NCT01509079|BG001|Baseline|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
11086809|NCT01509079|BG002|Baseline|Total|Total of all reporting groups
11086810|NCT01509079|FG000|Participant Flow|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
11086811|NCT01509079|FG001|Participant Flow|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
11227977|NCT02387814|BG001|Baseline|Abemaciclib: Mild Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with mild hepatic impairment.
11227978|NCT02387814|BG002|Baseline|Abemaciclib: Moderate Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment.
11227979|NCT02387814|BG003|Baseline|Abemaciclib: Severe Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with severe hepatic impairment.
11227980|NCT02387814|BG004|Baseline|Total|Total of all reporting groups
11227981|NCT02387814|FG000|Participant Flow|Abemaciclib: Normal Hepatic Function|200 milligrams (mg) abemaciclib administered once, orally, to participants with normal hepatic function.
11086812|NCT01509079|OG000|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
11086813|NCT01509079|OG001|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
11086814|NCT01509079|EG000|Reported Event|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
11086815|NCT01509079|EG001|Reported Event|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
11086816|NCT01509105|BG000|Baseline|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
11086817|NCT01509105|FG000|Participant Flow|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
11086818|NCT01509105|OG000|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
11086819|NCT01509105|EG000|Reported Event|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
11086820|NCT01509183|BG000|Baseline|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
11086821|NCT01509183|BG001|Baseline|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
11086822|NCT01509183|BG002|Baseline|Total|Total of all reporting groups
11086823|NCT01509183|FG000|Participant Flow|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
11086824|NCT01509183|FG001|Participant Flow|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
11086825|NCT01509183|OG000|Outcome|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
11086826|NCT01509183|OG001|Outcome|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
11227982|NCT02387814|FG001|Participant Flow|Abemaciclib: Mild Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with mild hepatic impairment.
11227983|NCT02387814|FG002|Participant Flow|Abemaciclib: Moderate Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment.
11086827|NCT01509183|EG000|Reported Event|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
11086828|NCT01509183|EG001|Reported Event|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
11086829|NCT01509404|BG000|Baseline|Valcyte - Kidney Transplant|Subjects who received a kidney transplant and assigned to the Valcyte only Treatment arm.
11086830|NCT01509404|BG001|Baseline|Valcyte Then Cytogam - Kidney Transplant|Subjects who received a kidney transplant and assigned to the Valcyte then CytogamTreatment arm.
11086831|NCT01509404|BG002|Baseline|Valcyte - Liver Transplant|Subjects who received a liver transplant and assigned to the Valcyte only Treatment arm.
11086832|NCT01509404|BG003|Baseline|Valcyte Then Cytogam - Liver Transplant|Subjects who received a liver transplant and assigned to the Valcyte then Cytogam Treatment arm.
11086833|NCT01509404|BG004|Baseline|Total|Total of all reporting groups
11086834|NCT01509404|FG000|Participant Flow|Valcyte|"valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant~Valganciclovir: Valcyte per package insert guidelines for 200 days post transplant"
11086835|NCT01509404|FG001|Participant Flow|Valcyte Then Cytogam|"valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection~CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant~Valganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant"
11086836|NCT01509404|OG000|Outcome|Valcyte|"valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant~Valganciclovir: Valcyte per package insert guidelines for 200 days post transplant"
11086837|NCT01509404|OG001|Outcome|Valcyte Then Cytogam|"valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection~CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant~Valganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant"
11086838|NCT01509404|EG000|Reported Event|Valcyte|"valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant~Valganciclovir: Valcyte per package insert guidelines for 200 days post transplant"
11086839|NCT01509404|EG001|Reported Event|Valcyte Then Cytogam|"valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection~CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant~Valganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant"
11086840|NCT01509547|BG000|Baseline|Varenicline|"Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.~Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter."
11086841|NCT01509547|BG001|Baseline|Placebo|"Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.~placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter."
11086842|NCT01509547|BG002|Baseline|Total|Total of all reporting groups
11086843|NCT01509547|FG000|Participant Flow|Varenicline|"Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.~Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter."
11227984|NCT02387814|FG003|Participant Flow|Abemaciclib: Severe Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with severe hepatic impairment.
11227985|NCT02387814|OG000|Outcome|Abemaciclib: Normal Hepatic Function|200 mg abemaciclib administered once, orally, to participants with normal hepatic function.
11227986|NCT02387814|OG001|Outcome|Abemaciclib: Mild Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with mild hepatic impairment.
11227987|NCT02387814|OG002|Outcome|Abemaciclib: Moderate Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment.
11227988|NCT02387814|OG003|Outcome|Abemaciclib: Severe Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with severe hepatic impairment.
11227989|NCT02387814|EG000|Reported Event|Abemaciclib: Normal Hepatic Function|200 mg abemaciclib administered once, orally, to participants with normal hepatic function.
11086844|NCT01509547|FG001|Participant Flow|Placebo|"Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.~placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter."
11086845|NCT01509547|OG000|Outcome|Varenicline|"Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.~Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter."
11086846|NCT01509547|OG001|Outcome|Placebo|"Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.~placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter."
11086847|NCT01509547|EG000|Reported Event|Varenicline|"Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.~Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter."
11086848|NCT01509547|EG001|Reported Event|Placebo|"Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.~placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter."
11086849|NCT01509586|BG000|Baseline|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
11086850|NCT01509586|BG001|Baseline|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
11086851|NCT01509586|BG002|Baseline|Total|Total of all reporting groups
11086852|NCT01509586|FG000|Participant Flow|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
11086853|NCT01509586|FG001|Participant Flow|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
11086854|NCT01509586|OG000|Outcome|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
11086855|NCT01509586|OG001|Outcome|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
11086856|NCT01509586|EG000|Reported Event|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
11086857|NCT01509586|EG001|Reported Event|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
11227990|NCT02387814|EG001|Reported Event|Abemaciclib: Mild Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with mild hepatic impairment.
11227991|NCT02387814|EG002|Reported Event|Abemaciclib: Moderate Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment.
11227992|NCT02387814|EG003|Reported Event|Abemaciclib: Severe Hepatic Impairment|200 mg abemaciclib administered once, orally, to participants with severe hepatic impairment.
11086858|NCT01509612|BG000|Baseline|Additive Homeopathy in Cancer Patients|"Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules~Additive classical homeopathy: Homeopathic remedies every 2 to 3 months"
11227993|NCT02387840|BG000|Baseline|NF1-associated Optic Pathway Glioma (OPG)|"Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11227994|NCT02387840|BG001|Baseline|NF1 Without Brain Tumor|"Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11227995|NCT02387840|BG002|Baseline|Without NF1 and With Brain Tumor Exposed to Therapy|"Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11227996|NCT02387840|BG003|Baseline|Without NF1 and With Untreated Low Grade Brain Tumors|"Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11227997|NCT02387840|BG004|Baseline|Without NF1 and Without Brain Tumors|"Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11227998|NCT02387840|BG005|Baseline|Brain Tumors of Assorted Pathology|"Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11227999|NCT02387840|BG006|Baseline|Total|Total of all reporting groups
11228000|NCT02387840|FG000|Participant Flow|NF1-associated Optic Pathway Glioma (OPG)|"Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228001|NCT02387840|FG001|Participant Flow|NF1 Without Brain Tumor|"Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11086859|NCT01509612|BG001|Baseline|Additive Homeopathic Placebo Globules|"Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules~Homeopathic Placebo globules: Homeopathic placebo globules every 2 to 3 months"
11228002|NCT02387840|FG002|Participant Flow|Without NF1 and With Brain Tumor Exposed to Therapy|"Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228003|NCT02387840|FG003|Participant Flow|Without NF1 and With Untreated Low Grade Brain Tumors|"Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228004|NCT02387840|FG004|Participant Flow|Without NF1 and Without Brain Tumors|"Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228005|NCT02387840|FG005|Participant Flow|Brain Tumors of Assorted Pathology|"Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228006|NCT02387840|OG000|Outcome|NF1-associated Optic Pathway Glioma (OPG)|"Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228007|NCT02387840|OG001|Outcome|NF1 Without Brain Tumor|"Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228008|NCT02387840|OG002|Outcome|Without NF1 and With Brain Tumor Exposed to Therapy|"Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228009|NCT02387840|OG003|Outcome|Without NF1 and With Untreated Low Grade Brain Tumors|"Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
10851387|NCT00306202|OG000|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained.
11086860|NCT01509612|BG002|Baseline|No Intervention|Lung cancer patients receiving conventional chemo- and/or radiation therapy but neither homeopathic remedies nor homeopathic placebo globules, these patients served as a non-intervention control group
11086861|NCT01509612|BG003|Baseline|Total|Total of all reporting groups
11086862|NCT01509612|FG000|Participant Flow|Homeopathic Placebo Globules|Cancer patients received homeopathic placebo remedies
11086863|NCT01509612|FG001|Participant Flow|Additive Classical Homeopathy in Cancer Patients|Lung cancer patients receive additive classical homeopathy with homeopathic remedies
11086864|NCT01509612|FG002|Participant Flow|No Intervention Group|The patients in this group received no intervention
11086865|NCT01509612|OG000|Outcome|Homeopathic Placebo Globules|Cancer patients received homeopathic placebo remedies
11086866|NCT01509612|OG001|Outcome|Additive Classical Homeopathy in Cancer Patients|Lung cancer patients receive additive classical homeopathy with homeopathic remedies
11086867|NCT01509612|OG002|Outcome|No Intervention Group|Lung cancer patients received conventional anti-cancer therapy, but neither homeopathic remedies nor homeopathic placebo globules. Data not collected for the no Intervention Group.
11086868|NCT01509612|OG000|Outcome|Additive Homeopathy in Cancer Patients|"Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules~Additive classical homeopathy: Homeopathic remedies every 2 to 3 months"
11086869|NCT01509612|OG001|Outcome|Additive Homeopathic Placebo Globules|"Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules~Homeopathic Placebo globules: Homeopathic placebo globules every 2 to 3 months"
11086870|NCT01509612|OG002|Outcome|No Intervention|No homeopathic or placebo intervention
11228010|NCT02387840|OG004|Outcome|Without NF1 and Without Brain Tumors|"Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11086871|NCT01509612|EG000|Reported Event|Homeopathic Placebo Globules|"Cancer patients received homeopathic placebo remedies.~Treatment emergent and serious adverse events were documented."
11086872|NCT01509612|EG001|Reported Event|Additive Classical Homeopathy in Cancer Patients|"Lung cancer patients receive additive classical homeopathy with homeopathic remedies~Treatment emergent and serious adverse events were documented."
11086873|NCT01509612|EG002|Reported Event|No Intervention Group|"Patients received no intervention.~Treatment emergent and serious adverse events were documented."
11086874|NCT01509625|BG000|Baseline|One Arm of Metastatic RE Breast Cancer Patients|Women with metastatic breast cancer who have disease progresion after prior antiestrogen treatment. All tumors were positive estrogen receptors
11086875|NCT01509625|FG000|Participant Flow|One Arm of Metastatic Breast Cancer Patients|All the patients have tumors with positive estrogen receptors
11086876|NCT01509625|OG000|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
11086877|NCT01509625|OG000|Outcome|Patients With Clinical Benefit|Patients wich achieved a clinical benefit with fulvetrant 500: complete response, partial response or stable disease of 24 weeks or longer
11086878|NCT01509625|OG000|Outcome|Patients Without Visceral Metastasis|Group of patients without metastasis in organs like liver or lungs
11086879|NCT01509625|OG001|Outcome|Patients With Visceral Metastasis|Group of patients with metastasis in organs like liver or lungs
11086880|NCT01509625|OG000|Outcome|Previous Treatment Wiht One Line of Hormonal Treatment|Hormonal treatment was tamoxifen or an aromatase inhibitor
11086881|NCT01509625|OG001|Outcome|Previous Treatment With Two or More Hormonal Treatment Lines|The patients have received at least two hormonal treatment: tamoxifen and aromatase inhibitor
11086882|NCT01509625|OG000|Outcome|Patients With Tumors HER2 Positive|tumor is considered HER2 positive if there is a sobreexpression of the receptor by immunohistochemistry or FISH is positive
11086883|NCT01509625|OG001|Outcome|Patients With Tumors HER2 Negative|tumor is considered HER2 negative if there is not a sobreexpression of the receptor by immunohistochemistry or FISH is positive
11086884|NCT01509625|OG000|Outcome|Patients With Tumors ki67 Positive|Patients with tumors with high ki67 expression
11086885|NCT01509625|OG001|Outcome|Patients With Tumors ki67 Negative|Patients with tumors with low ki67 expression
11086886|NCT01509625|EG000|Reported Event|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
11086887|NCT01509638|BG000|Baseline|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
11086888|NCT01509638|BG001|Baseline|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
11086889|NCT01509638|BG002|Baseline|Total|Total of all reporting groups
11086890|NCT01509638|FG000|Participant Flow|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
11086891|NCT01509638|FG001|Participant Flow|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
11086892|NCT01509638|OG000|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
11086893|NCT01509638|OG001|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
11086894|NCT01509638|EG000|Reported Event|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
11086895|NCT01509638|EG001|Reported Event|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
11086896|NCT01509664|BG000|Baseline|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
11086897|NCT01509664|BG001|Baseline|Control|Received no discount at the participating supermarket.
11086898|NCT01509664|BG002|Baseline|Total|Total of all reporting groups
11086899|NCT01509664|FG000|Participant Flow|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
11086900|NCT01509664|FG001|Participant Flow|Control|Received no discount at the participating supermarket.
11086901|NCT01509664|OG000|Outcome|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
11228011|NCT02387840|OG005|Outcome|Brain Tumors of Assorted Pathology|"Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228012|NCT02387840|OG000|Outcome|Arms 1, 3, and 4 - Low Grade Gliomas|Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 3: Without NF1 and with brain tumor exposed to therapy Arm 4: Without NF1 and with untreated low grade brain tumors
11086902|NCT01509664|OG001|Outcome|Control|Received no discount at the participating supermarket.
11086903|NCT01509664|EG000|Reported Event|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
11086904|NCT01509664|EG001|Reported Event|Control|Received no discount at the participating supermarket.
11086905|NCT01509677|BG000|Baseline|R500|Roflumilast 500 µg
11228013|NCT02387840|OG001|Outcome|Arms 1, 3, and 4 - Normal Appearing White Matter|Arms 1, 3, and 4 - Normal appearing white matter
11228014|NCT02387840|OG000|Outcome|Arm 6 - High Grade Gliomas|Arm 6 - High Grade Gliomas
11228015|NCT02387840|OG001|Outcome|Arm 6 - Normal Appearing White Matter|Arm 6 - Normal appearing white matter
11228016|NCT02387840|OG000|Outcome|Arms 1 & 4 - Untreated LGG|"Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 4: Without NF1 and with untreated low grade brain tumors~The untreated LGG group consisted of Arm 4 and untreated participants from Arm 1."
11086906|NCT01509677|BG001|Baseline|Placebo|Placebo to Roflumilast
11086907|NCT01509677|BG002|Baseline|Total|Total of all reporting groups
11086908|NCT01509677|FG000|Participant Flow|R500|Roflumilast 500 µg
11086909|NCT01509677|FG001|Participant Flow|Placebo|Placebo to Roflumilast
11086910|NCT01509677|OG000|Outcome|R500|Roflumilast 500 µg
11086911|NCT01509677|OG001|Outcome|Placebo|Placebo to Roflumilast
11086912|NCT01509677|EG000|Reported Event|R500|Roflumilast 500 µg
11086913|NCT01509677|EG001|Reported Event|Placebo|Placebo to Roflumilast
11086914|NCT01509807|BG000|Baseline|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
11086915|NCT01509807|BG001|Baseline|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
11086916|NCT01509807|BG002|Baseline|Total|Total of all reporting groups
11086917|NCT01509807|FG000|Participant Flow|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
11086918|NCT01509807|FG001|Participant Flow|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
11086919|NCT01509807|OG000|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
11086920|NCT01509807|OG001|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
11086921|NCT01509807|EG000|Reported Event|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
11086922|NCT01509807|EG001|Reported Event|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
11086923|NCT01509846|BG000|Baseline|Cohort 1|"Received one oral dose of 2.6±0.8 x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0"
11086924|NCT01509846|BG001|Baseline|Cohort 2|"Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56"
11086925|NCT01509846|BG002|Baseline|Cohort 3|"Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56"
11086926|NCT01509846|BG003|Baseline|Cohort 4|"Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56"
11086927|NCT01509846|BG004|Baseline|Placebo|"Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).~Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)"
11086928|NCT01509846|BG005|Baseline|Total|Total of all reporting groups
11086929|NCT01509846|FG000|Participant Flow|Cohort 1|"Received one oral dose of 2.6±0.8 x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0"
11086930|NCT01509846|FG001|Participant Flow|Cohort 2|"Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56"
11086931|NCT01509846|FG002|Participant Flow|Cohort 3|"Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56"
11086932|NCT01509846|FG003|Participant Flow|Cohort 4|"Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56"
11086933|NCT01509846|FG004|Participant Flow|Placebo|"Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).~Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)"
11086934|NCT01509846|OG000|Outcome|Cohort 1|"Received one oral dose of 2.6±0.8 x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0"
11086935|NCT01509846|OG001|Outcome|Cohort 2|"Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56"
11086936|NCT01509846|OG002|Outcome|Cohort 3|"Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56"
11086937|NCT01509846|OG003|Outcome|Cohort 4|"Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56"
11086938|NCT01509846|OG004|Outcome|Placebo|"Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).~Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)"
11086939|NCT01509846|OG000|Outcome|Cohort 3: Placebo|Received 3 oral doses of placebo for comparison with Cohort 3 subjects that received vaccine.
11228017|NCT02387840|OG001|Outcome|Arms 1 & 3 - Treated LGGs|"Arm 1: NF1-associated Optic Pathway Glioma (OPG) Arm 3: Without NF1 and with brain tumor exposed to therapy~The Treated LGG group consisted of Arm 3 and treated patients from Arm 1"
11086940|NCT01509846|OG001|Outcome|Cohort 3: Vaccine|"Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56"
11086941|NCT01509846|OG000|Outcome|Cohort 4: Placebo|Received 3 oral doses of placebo for comparison with Cohort 4 subjects that received vaccine.
11233822|NCT02431260|OG000|Outcome|INCB054329 Monotherapy|INCB054329 Monotherapy: Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the treatment group A (TGA), with subsequent cohort escalations in the three treatment groups (TGA, TGB, and TGC) based on protocol-specific criteria
11086942|NCT01509846|OG001|Outcome|Cohort 4: Vaccine|"Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56"
11086943|NCT01509846|OG001|Outcome|Cohort 4: Placebo|Received 3 oral doses of placebo for comparison with Cohort 4 subjects that received vaccine.
11086944|NCT01509846|OG002|Outcome|Cohort 3: Vaccine|"Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56"
11086945|NCT01509846|OG003|Outcome|Cohort 4: Vaccine|"Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56"
11086946|NCT01509846|EG000|Reported Event|Cohort 1|"Received one oral dose of 2.6±0.8 x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0"
11086947|NCT01509846|EG001|Reported Event|Cohort 2|"Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56"
11086948|NCT01509846|EG002|Reported Event|Cohort 3|"Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56"
11086949|NCT01509846|EG003|Reported Event|Cohort 4|"Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)~Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56"
11086950|NCT01509846|EG004|Reported Event|Placebo|"Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).~Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)"
11086951|NCT01509872|BG000|Baseline|Trauma-Focused Cognitive Behavioral Therapy|"Trauma-Focused Cognitive Behaviour Therapy (Cohen, Mannarino, Deblinger, 2006; Smith and Saunders, 2005) is a child-friendly, manualised psychological intervention for children who experience nightmares, flashbacks, anxiety, anger, social isolation, poor concentration or self-blame after experiencing or witnessing a violent and terrifying life event (e.g. rape, murder, abduction etc). This intervention was culturally modified for use with war-affected children.~Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy"
11086952|NCT01509872|BG001|Baseline|A Child Friendly Space|"A Child Friendly Space is a psychosocial intervention combining creative (e.g. art), imaginative (e.g. drama), physical (e.g. football), communicative (e.g. group discussions) and manipulative activities (e.g. story telling). It aids children's natural development by providing a safe place for children to learn, express themselves, grow and develop, supported by trained animators and peer educators.~Child Friendly Space: 9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention"
11086953|NCT01509872|BG002|Baseline|Total|Total of all reporting groups
11086954|NCT01509872|FG000|Participant Flow|Trauma-Focused Cognitive Behavioral Therapy|"Trauma-Focused Cognitive Behaviour Therapy (Cohen, Mannarino, Deblinger, 2006; Smith and Saunders, 2005) is a child-friendly, manualised psychological intervention for children who experience nightmares, flashbacks, anxiety, anger, social isolation, poor concentration or self-blame after experiencing or witnessing a violent and terrifying life event (e.g. rape, murder, abduction etc). This intervention was culturally modified for use with war-affected children.~Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy"
11086955|NCT01509872|FG001|Participant Flow|A Child Friendly Space|"A Child Friendly Space is a psychosocial intervention combining creative (e.g. art), imaginative (e.g. drama), physical (e.g. football), communicative (e.g. group discussions) and manipulative activities (e.g. story telling). It aids children's natural development by providing a safe place for children to learn, express themselves, grow and develop, supported by trained animators and peer educators.~Child Friendly Space: 9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention"
11086956|NCT01509872|OG000|Outcome|Trauma-Focused Cognitive Behavioral Therapy|"Trauma-Focused Cognitive Behaviour Therapy (Cohen, Mannarino, Deblinger, 2006; Smith and Saunders, 2005) is a child-friendly, manualised psychological intervention for children who experience nightmares, flashbacks, anxiety, anger, social isolation, poor concentration or self-blame after experiencing or witnessing a violent and terrifying life event (e.g. rape, murder, abduction etc). This intervention was culturally modified for use with war-affected children.~Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy"
11086957|NCT01509872|OG001|Outcome|A Child Friendly Space|"A Child Friendly Space is a psychosocial intervention combining creative (e.g. art), imaginative (e.g. drama), physical (e.g. football), communicative (e.g. group discussions) and manipulative activities (e.g. story telling). It aids children's natural development by providing a safe place for children to learn, express themselves, grow and develop, supported by trained animators and peer educators.~Child Friendly Space: 9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention"
11086958|NCT01509872|OG000|Outcome|Trauma-Focused Cognitive Behavioral Therapy|
11086959|NCT01509872|OG001|Outcome|A Child Friendly Space|
11086960|NCT01509872|EG000|Reported Event|Trauma-Focused Cognitive Behavioral Therapy|"Trauma-Focused Cognitive Behaviour Therapy (Cohen, Mannarino, Deblinger, 2006; Smith and Saunders, 2005) is a child-friendly, manualised psychological intervention for children who experience nightmares, flashbacks, anxiety, anger, social isolation, poor concentration or self-blame after experiencing or witnessing a violent and terrifying life event (e.g. rape, murder, abduction etc). This intervention was culturally modified for use with war-affected children.~Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy"
11086961|NCT01509872|EG001|Reported Event|A Child Friendly Space|"A Child Friendly Space is a psychosocial intervention combining creative (e.g. art), imaginative (e.g. drama), physical (e.g. football), communicative (e.g. group discussions) and manipulative activities (e.g. story telling). It aids children's natural development by providing a safe place for children to learn, express themselves, grow and develop, supported by trained animators and peer educators.~Child Friendly Space: 9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention"
11086962|NCT01509950|BG000|Baseline|Staples|"Use of staples for skin closure at cesarean section~Staples: Staples for closure of cesarean section skin incision"
11086963|NCT01509950|BG001|Baseline|Prolene Non-absorbable Sutures|"Use of Prolene non-absorbable sutures for skin closure at cesarean section~Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision"
11086964|NCT01509950|BG002|Baseline|Total|Total of all reporting groups
11086965|NCT01509950|FG000|Participant Flow|Staples|"Use of staples for skin closure at cesarean section~Staples: Staples for closure of cesarean section skin incision"
11086966|NCT01509950|FG001|Participant Flow|Prolene Non-absorbable Sutures|"Use of Prolene non-absorbable sutures for skin closure at cesarean section~Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision"
11086967|NCT01509950|FG002|Participant Flow|Absorbable Sutures|"Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.~Absorbable Sutures: Absorbable sutures for closure of cesarean skin incision"
11086968|NCT01509950|OG000|Outcome|Staples|"Use of staples for skin closure at cesarean section~Staples: Staples for closure of cesarean section skin incision"
11086969|NCT01509950|OG001|Outcome|Prolene Non-absorbable Sutures|"Use of Prolene non-absorbable sutures for skin closure at cesarean section~Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision"
11086970|NCT01509950|EG000|Reported Event|Staples|"Use of staples for skin closure at cesarean section~Staples: Staples for closure of cesarean section skin incision"
11086971|NCT01509950|EG001|Reported Event|Prolene Non-absorbable Sutures|"Use of Prolene non-absorbable sutures for skin closure at cesarean section~Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision"
11086972|NCT01510028|BG000|Baseline|SHP611 10 mg (Process A)|Participants received 10 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086973|NCT01510028|BG001|Baseline|SHP611 30 mg (Process A)|Participants received 30 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086974|NCT01510028|BG002|Baseline|SHP611 100 mg (Process A)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086975|NCT01510028|BG003|Baseline|SHP611 100 mg (Process B)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the revised drug substance manufacturing process referred to as Process B.
11086976|NCT01510028|BG004|Baseline|Total|Total of all reporting groups
11086977|NCT01510028|FG000|Participant Flow|SHP611 10 mg (Process A)|Participants received 10 milligram (mg) dose of SHP611 (HGT-1110, recombinant human arylsulfatase A [rhASA]) every other week (EOW) by intrathecal drug delivery device (IDDD) for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086978|NCT01510028|FG001|Participant Flow|SHP611 30 mg (Process A)|Participants received 30 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086979|NCT01510028|FG002|Participant Flow|SHP611 100 mg (Process A)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086980|NCT01510028|FG003|Participant Flow|SHP611 100 mg (Process B)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the revised drug substance manufacturing process referred to as Process B.
11086981|NCT01510028|OG000|Outcome|SHP611 10 mg (Process A)|Participants received 10 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086982|NCT01510028|OG001|Outcome|SHP611 30 mg (Process A)|Participants received 30 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086983|NCT01510028|OG002|Outcome|SHP611 100 mg (Process A)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086984|NCT01510028|OG003|Outcome|SHP611 100 mg (Process B)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the revised drug substance manufacturing process referred to as Process B.
11086985|NCT01510028|OG000|Outcome|SHP611 100 mg (Process A)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the original drug substance manufacturing process referred to as Process A.
11086986|NCT01510028|OG001|Outcome|SHP611 100 mg (Process B)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks. In this cohort, participants received SHP611 produced with the revised drug substance manufacturing process referred to as Process B.
11086987|NCT01510028|EG000|Reported Event|SHP611 10 mg (Process A)|Participants received 10 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks.
11086988|NCT01510028|EG001|Reported Event|SHP611 30 mg (Process A)|Participants received 30 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks.
11086989|NCT01510028|EG002|Reported Event|SHP611 100 mg (Process A)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks.
11086990|NCT01510028|EG003|Reported Event|SHP611 100 mg (Process B)|Participants received 100 mg dose of SHP611 (HGT-1110, rhASA) EOW by IDDD for 38 weeks.
11086991|NCT01510145|BG000|Baseline|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
11086992|NCT01510145|FG000|Participant Flow|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
11086993|NCT01510145|OG000|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
11086994|NCT01510145|EG000|Reported Event|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
11086995|NCT01510158|BG000|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
11086996|NCT01510158|BG001|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
11086997|NCT01510158|BG002|Baseline|Placebo + Allopurinol|placebo qd plus allopurinol
11086998|NCT01510158|BG003|Baseline|Total|Total of all reporting groups
11086999|NCT01510158|FG000|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
11087000|NCT01510158|FG001|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
11087001|NCT01510158|FG002|Participant Flow|Placebo + Allopurinol|placebo qd plus allopurinol
11087002|NCT01510158|OG000|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
11087003|NCT01510158|OG001|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
11087004|NCT01510158|OG002|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
11087005|NCT01510158|EG000|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
11087006|NCT01510158|EG001|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
11087007|NCT01510158|EG002|Reported Event|Placebo + Allopurinol|placebo qd plus allopurinol
11087008|NCT01510327|BG000|Baseline|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
11087009|NCT01510327|FG000|Participant Flow|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
11087010|NCT01510327|OG000|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents
11087011|NCT01510327|OG001|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
11087012|NCT01510327|OG002|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
11087013|NCT01510327|OG000|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
11087014|NCT01510327|OG001|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
11087015|NCT01510327|OG002|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
11087016|NCT01510327|OG000|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
11087017|NCT01510327|EG000|Reported Event|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
11087018|NCT01510379|BG000|Baseline|Reletex|Reletex plus scheduled ondansetron and phenergan prn
11087019|NCT01510379|BG001|Baseline|Control|Scheduled ondansetron plus phenergan prn
11087020|NCT01510379|BG002|Baseline|Total|Total of all reporting groups
11087021|NCT01510379|FG000|Participant Flow|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
11087022|NCT01510379|FG001|Participant Flow|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
11087023|NCT01510379|OG000|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
11087024|NCT01510379|OG001|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
11087025|NCT01510379|EG000|Reported Event|Reletex|Reletex plus scheduled ondansetron and phenergan prn
11087026|NCT01510379|EG001|Reported Event|Control|Scheduled ondansetron plus phenergan prn
11087027|NCT01510457|BG000|Baseline|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
11233823|NCT02431260|OG000|Outcome|Part 2 / Treatment Group A: 20 MG BID INCB054329|Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
11087028|NCT01510457|BG001|Baseline|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
11087029|NCT01510457|BG002|Baseline|Total|Total of all reporting groups
11087030|NCT01510457|FG000|Participant Flow|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
11087031|NCT01510457|FG001|Participant Flow|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
11228018|NCT02387840|EG000|Reported Event|NF1-associated Optic Pathway Glioma (OPG)|"Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228019|NCT02387840|EG001|Reported Event|NF1 Without Brain Tumor|"Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228020|NCT02387840|EG002|Reported Event|Without NF1 and With Brain Tumor Exposed to Therapy|"Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228021|NCT02387840|EG003|Reported Event|Without NF1 and With Untreated Low Grade Brain Tumors|"Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228022|NCT02387840|EG004|Reported Event|Without NF1 and Without Brain Tumors|"Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228023|NCT02387840|EG005|Reported Event|Brain Tumors of Assorted Pathology|"Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting~Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.~Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2)."
11228024|NCT02387853|BG000|Baseline|LEO 90100|LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set.
11228025|NCT02387853|FG000|Participant Flow|LEO 90100|LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
11228026|NCT02387853|OG000|Outcome|LEO 90100|LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
11228027|NCT02387853|EG000|Reported Event|LEO 90100|LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional HPA axis assessments and constitute the per protocol analysis set.
11228028|NCT02387957|BG000|Baseline|Fovista® Plus Bevacizumab|"Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection~Fovista®~bevacizumab"
11087032|NCT01510457|OG000|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
11087033|NCT01510457|OG001|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
11087034|NCT01510457|OG000|Outcome|Sugar Pill|"BID placebo~Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication."
11087035|NCT01510457|OG001|Outcome|Milnacipran|"Uptitration from 10mg to 50mg BID Milnacipran~Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used."
11087036|NCT01510457|EG000|Reported Event|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
11087037|NCT01510457|EG001|Reported Event|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
11087038|NCT01510652|BG000|Baseline|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
11087039|NCT01510652|BG001|Baseline|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
11087040|NCT01510652|BG002|Baseline|Total|Total of all reporting groups
11087041|NCT01510652|FG000|Participant Flow|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
11087042|NCT01510652|FG001|Participant Flow|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
11087043|NCT01510652|OG000|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
11087044|NCT01510652|OG001|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
11087045|NCT01510652|EG000|Reported Event|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
11087046|NCT01510652|EG001|Reported Event|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
11087047|NCT01510704|BG000|Baseline|Placebo|
11087048|NCT01510704|BG001|Baseline|Low Dose APD421|1mg dose level
11087049|NCT01510704|BG002|Baseline|Mid Dose APD421|5mg dose level
11087050|NCT01510704|BG003|Baseline|High Dose APD421|20mg dose level
11087051|NCT01510704|BG004|Baseline|Total|Total of all reporting groups
11087052|NCT01510704|FG000|Participant Flow|Placebo|Single-dose IV placebo
11087053|NCT01510704|FG001|Participant Flow|Low Dose APD421|Single-dose 1 mg IV APD421
11087054|NCT01510704|FG002|Participant Flow|Mid Dose APD421|Single-dose 5 mg IV APD421
11228029|NCT02387957|BG001|Baseline|Fovista® Plus Ranibizumab|"Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection~Fovista®~ranibizumab"
11228030|NCT02387957|BG002|Baseline|Fovista® Plus Aflibercept|"Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection~Fovista®~aflibercept"
11228031|NCT02387957|BG003|Baseline|Total|Total of all reporting groups
11228032|NCT02387957|FG000|Participant Flow|Fovista® Plus Bevacizumab|"Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection~Fovista®~bevacizumab"
11087055|NCT01510704|FG003|Participant Flow|High Dose APD421|Single-dose 20 mg IV APD421
11087056|NCT01510704|OG000|Outcome|Placebo|
11087057|NCT01510704|OG001|Outcome|Low Dose APD421|1mg dose level
11087058|NCT01510704|OG002|Outcome|Mid Dose APD421|5mg dose level
11087059|NCT01510704|OG003|Outcome|High Dose APD421|20mg dose level
11087060|NCT01510704|EG000|Reported Event|Placebo|
11087061|NCT01510704|EG001|Reported Event|Low Dose APD421|1mg dose level
11087062|NCT01510704|EG002|Reported Event|Mid Dose APD421|5mg dose level
11087063|NCT01510704|EG003|Reported Event|High Dose APD421|20mg dose level
11087064|NCT01510717|BG000|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
11087065|NCT01510717|BG001|Baseline|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
11087066|NCT01510717|BG002|Baseline|Total|Total of all reporting groups
11087067|NCT01510717|FG000|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
11087068|NCT01510717|FG001|Participant Flow|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
11087069|NCT01510717|OG000|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
11087070|NCT01510717|OG001|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
11087071|NCT01510717|EG000|Reported Event|Pre-Treatment|All enrolled participants
11087072|NCT01510717|EG001|Reported Event|Multifocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
11087073|NCT01510717|EG002|Reported Event|Monofocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ Monofocal IOL Model SN60WF
11087074|NCT01510769|BG000|Baseline|Lesinurad 200 mg + Febuxostat|
11087075|NCT01510769|BG001|Baseline|Lesinurad 400 mg + Febuxostat|
11087076|NCT01510769|BG002|Baseline|Placebo + Febuxostat|
11087077|NCT01510769|BG003|Baseline|Total|Total of all reporting groups
11087078|NCT01510769|FG000|Participant Flow|Lesinurad 200 mg + Febuxostat|
11087079|NCT01510769|FG001|Participant Flow|Lesinurad 400 mg + Febuxostat|
11087080|NCT01510769|FG002|Participant Flow|Placebo + Febuxostat|
11087081|NCT01510769|OG000|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
11087082|NCT01510769|OG001|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
11087083|NCT01510769|OG002|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
11087084|NCT01510769|EG000|Reported Event|Lesinurad 200 mg + Febuxostat|
11087085|NCT01510769|EG001|Reported Event|Lesinurad 400 mg + Febuxostat|
11087086|NCT01510769|EG002|Reported Event|Placebo + Febuxostat|
11087087|NCT01510834|BG000|Baseline|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
11087088|NCT01510834|FG000|Participant Flow|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
11087089|NCT01510834|OG000|Outcome|Mean Difference in PCL (T1, T3) (Negative Change is Better)|Mean difference in PCL (T1, T3) for study completers
11087090|NCT01510834|OG000|Outcome|Mean Difference in QOLS (T1, T3)|Mean Difference in QOLS (T1, T3)for study completers only
11087091|NCT01510834|OG000|Outcome|Mean Difference in PSS (T1, T3)|Mean difference in Perceived Stress Scale (T1, T3) for study completers
11087092|NCT01510834|OG000|Outcome|Mean Difference in PHQ-8 (T1, T3)|Mean Difference in PHQ-8 (T1,T3) for study completers
11087093|NCT01510834|EG000|Reported Event|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
11087094|NCT01510912|BG000|Baseline|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
11087095|NCT01510912|FG000|Participant Flow|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
11087096|NCT01510912|OG000|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
11087097|NCT01510912|EG000|Reported Event|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
11087098|NCT01511016|BG000|Baseline|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
11228033|NCT02387957|FG001|Participant Flow|Fovista® Plus Ranibizumab|"Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection~Fovista®~ranibizumab"
11087099|NCT01511016|BG001|Baseline|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
11087100|NCT01511016|BG002|Baseline|Total|Total of all reporting groups
11228034|NCT02387957|FG002|Participant Flow|Fovista® Plus Aflibercept|"Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection~Fovista®~aflibercept"
11228035|NCT02387957|OG000|Outcome|Fovista® Plus Bevacizumab|"Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection~Fovista®~bevacizumab"
11087101|NCT01511016|FG000|Participant Flow|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
11087102|NCT01511016|FG001|Participant Flow|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
11087103|NCT01511016|OG000|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
11087104|NCT01511016|OG001|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
11087105|NCT01511016|OG001|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
11087106|NCT01511016|EG000|Reported Event|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
11228036|NCT02387957|OG001|Outcome|Fovista® Plus Ranibizumab|"Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection~Fovista®~ranibizumab"
11228037|NCT02387957|OG002|Outcome|Fovista® Plus Aflibercept|"Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection~Fovista®~aflibercept"
11228038|NCT02387957|EG000|Reported Event|Fovista® Plus Bevacizumab|"Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection~Fovista®~bevacizumab"
11228039|NCT02387957|EG001|Reported Event|Fovista® Plus Ranibizumab|"Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection~Fovista®~ranibizumab"
11087107|NCT01511016|EG001|Reported Event|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
11087108|NCT01511055|BG000|Baseline|Folate-FITC|EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
11087109|NCT01511055|FG000|Participant Flow|Folate-FITC|EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
11087110|NCT01511055|OG000|Outcome|Folate-FITC|EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
11087111|NCT01511055|EG000|Reported Event|Folate-FITC|EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
11087112|NCT01511068|BG000|Baseline|Inhaled Leukine (rhGM-CSF)|"Inhaled recombinant human GM-CSF in individuals with Hereditary Pulmonary Alveolar Proteinosis (hPAP) due to partial dysfunction of the GM-CSF receptor~Leukine: Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks. Following an interim safety evaluation, participants may be entered into a second 12 week treatment period where participants will receive either 250 mcg or 500 mcg once weekly. At the end of any treatment period, participants will be followed for 12 additional weeks in the absence of inhaled rhGM-CSF to evaluate safety and efficacy."
11228040|NCT02387957|EG002|Reported Event|Fovista® Plus Aflibercept|"Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection~Fovista®~aflibercept"
11228041|NCT02387970|BG000|Baseline|Immediate Provisionalization|"Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery~Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.~NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.~Dental crown: A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
11228042|NCT02387970|BG001|Baseline|Delayed Provisionalization|"Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery~Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.~NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.~Dental crown: A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
11228043|NCT02387970|BG002|Baseline|Total|Total of all reporting groups
11087113|NCT01511068|FG000|Participant Flow|Inhaled Leukine (rhGM-CSF)|"Inhaled recombinant human GM-CSF in individuals with Hereditary Pulmonary Alveolar Proteinosis (hPAP) due to partial dysfunction of the GM-CSF receptor~Leukine: Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks. Following an interim safety evaluation, participants may be entered into a second 12 week treatment period where participants will receive either 250 mcg or 500 mcg once weekly. At the end of any treatment period, participants will be followed for 12 additional weeks in the absence of inhaled rhGM-CSF to evaluate safety and efficacy."
11087114|NCT01511068|OG000|Outcome|Inhaled Leukine (rhGM-CSF)|"Inhaled recombinant human GM-CSF in individuals with Hereditary Pulmonary Alveolar Proteinosis (hPAP) due to partial dysfunction of the GM-CSF receptor~Leukine: Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks. Following an interim safety evaluation, participants may be entered into a second 12 week treatment period where participants will receive either 250 mcg or 500 mcg once weekly. At the end of any treatment period, participants will be followed for 12 additional weeks in the absence of inhaled rhGM-CSF to evaluate safety and efficacy."
11087115|NCT01511068|EG000|Reported Event|Inhaled Leukine (rhGM-CSF)|"Inhaled recombinant human GM-CSF in individuals with Hereditary Pulmonary Alveolar Proteinosis (hPAP) due to partial dysfunction of the GM-CSF receptor~Leukine: Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks. Following an interim safety evaluation, participants may be entered into a second 12 week treatment period where participants will receive either 250 mcg or 500 mcg once weekly. At the end of any treatment period, participants will be followed for 12 additional weeks in the absence of inhaled rhGM-CSF to evaluate safety and efficacy."
11087116|NCT01511107|BG000|Baseline|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
11087117|NCT01511107|BG001|Baseline|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
11087118|NCT01511107|BG002|Baseline|Total|Total of all reporting groups
11087119|NCT01511107|FG000|Participant Flow|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
11087120|NCT01511107|FG001|Participant Flow|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
11087121|NCT01511107|OG000|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
11087122|NCT01511107|OG001|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
11087123|NCT01511107|EG000|Reported Event|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
11087124|NCT01511107|EG001|Reported Event|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
11233824|NCT02431260|OG001|Outcome|Part 2 / Treatment Group C: 20 mg BID INCB054329|Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
11087125|NCT01511250|BG000|Baseline|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087126|NCT01511250|BG001|Baseline|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
11087127|NCT01511250|BG002|Baseline|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087128|NCT01511250|BG003|Baseline|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
11087129|NCT01511250|BG004|Baseline|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087130|NCT01511250|BG005|Baseline|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
11087131|NCT01511250|BG006|Baseline|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087132|NCT01511250|BG007|Baseline|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
11087133|NCT01511250|BG008|Baseline|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087134|NCT01511250|BG009|Baseline|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
11087135|NCT01511250|BG010|Baseline|Total|Total of all reporting groups
11087136|NCT01511250|FG000|Participant Flow|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087137|NCT01511250|FG001|Participant Flow|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
11087138|NCT01511250|FG002|Participant Flow|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087139|NCT01511250|FG003|Participant Flow|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
11087140|NCT01511250|FG004|Participant Flow|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087141|NCT01511250|FG005|Participant Flow|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
11087142|NCT01511250|FG006|Participant Flow|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087143|NCT01511250|FG007|Participant Flow|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
11087144|NCT01511250|FG008|Participant Flow|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087145|NCT01511250|FG009|Participant Flow|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
11087146|NCT01511250|OG000|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087147|NCT01511250|OG001|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
11087148|NCT01511250|OG002|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087149|NCT01511250|OG003|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
11087150|NCT01511250|OG004|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087151|NCT01511250|OG005|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
11087152|NCT01511250|OG006|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087153|NCT01511250|OG007|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
11087154|NCT01511250|OG008|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087155|NCT01511250|OG009|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
11087156|NCT01511250|EG000|Reported Event|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087157|NCT01511250|EG001|Reported Event|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
11087158|NCT01511250|EG002|Reported Event|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087159|NCT01511250|EG003|Reported Event|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
11087160|NCT01511250|EG004|Reported Event|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087161|NCT01511250|EG005|Reported Event|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
11087162|NCT01511250|EG006|Reported Event|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087163|NCT01511250|EG007|Reported Event|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
11087164|NCT01511250|EG008|Reported Event|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
11087165|NCT01511250|EG009|Reported Event|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
11087166|NCT01511315|BG000|Baseline|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
11087167|NCT01511315|FG000|Participant Flow|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
11087168|NCT01511315|OG000|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
11087169|NCT01511315|EG000|Reported Event|Ustekinumab|Ustekinumab: Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
11092124|NCT01537419|BG001|Baseline|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
11092125|NCT01537419|BG002|Baseline|Total|Total of all reporting groups
11092126|NCT01537419|FG000|Participant Flow|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
11092127|NCT01537419|FG001|Participant Flow|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
11092128|NCT01537419|OG000|Outcome|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
11173714|NCT02017093|OG001|Outcome|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
11087170|NCT01511419|BG000|Baseline|LAIV H7N3|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol.~Duration of treatment: Two doses were delivered, one on Day 0 and one on Day 28.~LAIV H7N3: 2 doses of vaccine"
11087171|NCT01511419|BG001|Baseline|Placebo|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol~Duration of treatment: Two doses were delivered, one on Day 0 and one on Day 28~placebo: 2 doses of placebo"
11087172|NCT01511419|BG002|Baseline|Total|Total of all reporting groups
11087173|NCT01511419|FG000|Participant Flow|LAIV H7N3|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log egg infectious dose (EID) 50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol.~Duration of treatment: Two doses were delivered, one on Day 0 and one on Day 28."
11087174|NCT01511419|FG001|Participant Flow|Placebo|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol~Duration of treatment: Two doses were delivered, one on Day 0 and one on Day 28~placebo: 2 doses of placebo"
11087175|NCT01511419|OG000|Outcome|LAIV H7N3: Dose 1 (Day 0)|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087176|NCT01511419|OG001|Outcome|Placebo: Dose 1 (Day 0)|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11087177|NCT01511419|OG002|Outcome|LAIV H7N3: Dose 2 (Day 28)|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087178|NCT01511419|OG003|Outcome|Placebo: Dose 2 (Day 28)|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11087179|NCT01511419|OG000|Outcome|LAIV H7N3: Dose 1|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087180|NCT01511419|OG001|Outcome|Placebo: Dose 1|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11087181|NCT01511419|OG002|Outcome|LAIV H7N3: Dose 2|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087182|NCT01511419|OG003|Outcome|Placebo: Dose 2|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11087183|NCT01511419|OG000|Outcome|LAIV H7N3|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol.~Duration of treatment: Two doses were delivered, one on Day 0 and one on Day 28.~LAIV H7N3: 2 doses of vaccine"
11087184|NCT01511419|OG001|Outcome|Placebo|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol~Duration of treatment: Two doses were delivered, one on Day 0 and one on Day 28~placebo: 2 doses of placebo"
11087185|NCT01511419|OG000|Outcome|Day 1|LAIV H7N3 Arm
11087186|NCT01511419|OG001|Outcome|Day 2|LAIV H7N3 Arm
11087187|NCT01511419|OG002|Outcome|Day 3|LAIV H7N3 Arm
11087188|NCT01511419|OG003|Outcome|Day 4|LAIV H7N3 Arm
11087189|NCT01511419|OG000|Outcome|Day 29|LAIV H7N3 Arm
11087190|NCT01511419|OG001|Outcome|Day 30|LAIV H7N3 Arm
11087191|NCT01511419|OG002|Outcome|Day 31|LAIV H7N3 Arm
11087192|NCT01511419|OG003|Outcome|Day 32|LAIV H7N3 Arm
11087193|NCT01511419|OG000|Outcome|LAIV H7N3: Day 0 (After Dose 1)|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087194|NCT01511419|OG001|Outcome|Placebo: Day 0 (After Dose 1)|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11087195|NCT01511419|OG002|Outcome|LAIV H7N3: Day 28 (Dose 2)|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087196|NCT01511419|OG003|Outcome|Placebo: Day 28 (Dose 2)|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11233825|NCT02431260|EG000|Reported Event|Part 1 / Treatment Group A: 15 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11087197|NCT01511419|OG004|Outcome|LAIV H7N3: Day 56 (28 Days Past Dose 2)|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087198|NCT01511419|OG005|Outcome|Placebo: Day 56 (28 Days Past Dose 2)|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11087199|NCT01511419|EG000|Reported Event|LAIV H7N3: Dose 1|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087200|NCT01511419|EG001|Reported Event|Placebo: Dose 1|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11087201|NCT01511419|EG002|Reported Event|LAIV H7N3: Dose 2|"Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs.~Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine.~Dose: ≥7.5 log EID50/0.5 ml dose; 0.25 ml/nare.~Route of administration: Intranasal aerosol."
11087202|NCT01511419|EG003|Reported Event|Placebo: Dose 2|"Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine.~Dose: 0.5 ml; 0.25 ml/nare~Route of administration: Intranasal aerosol"
11087203|NCT01511445|BG000|Baseline|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
11087204|NCT01511445|BG001|Baseline|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
11087205|NCT01511445|BG002|Baseline|Total|Total of all reporting groups
11087206|NCT01511445|FG000|Participant Flow|ACDF With Valeo CSC Ceramic Cage|"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood.~Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage: Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer."
11087207|NCT01511445|FG001|Participant Flow|ACDF With PEEK Interbody Cage|"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure.~Anterior cervical discectomy and fusion (ACDF) with PEEK Cage: Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer"
11087208|NCT01511445|OG000|Outcome|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
11087209|NCT01511445|OG001|Outcome|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
11087210|NCT01511445|EG000|Reported Event|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
11087211|NCT01511445|EG001|Reported Event|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
11087212|NCT01511536|BG000|Baseline|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087213|NCT01511536|BG001|Baseline|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087214|NCT01511536|BG002|Baseline|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087215|NCT01511536|BG003|Baseline|Total|Total of all reporting groups
11087216|NCT01511536|FG000|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087217|NCT01511536|FG001|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087218|NCT01511536|FG002|Participant Flow|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087219|NCT01511536|OG000|Outcome|Phase 1: Overall Population|Cabazitaxel 20 or 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087220|NCT01511536|OG000|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087221|NCT01511536|OG000|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087222|NCT01511536|EG000|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087223|NCT01511536|EG001|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087224|NCT01511536|EG002|Reported Event|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
11087225|NCT01511640|BG000|Baseline|300 mg/Day Pregabalin, Then Placebo|"300 mg/day Pregabalin, then Placebo~150 mg then 0 mg 2x daily for duration of treatment phase"
11087226|NCT01511640|BG001|Baseline|Placebo, Then 300 mg/Day Pregabalin|"Placebo, then 300 mg/day Pregabalin~0 mg then 150 mg 2x daily for duration of treatment phase"
11087227|NCT01511640|BG002|Baseline|450 mg/Day Pregabalin, Then Placebo|"450 mg/day Pregabalin, then Placebo~225 mg then 0 mg 2x daily for duration of treatment phase"
11087228|NCT01511640|BG003|Baseline|Placebo, Then 450 mg/Day Pregabalin|"Placebo, then 450 mg/day Pregabalin~0 mg then 225 mg 2x daily for duration of treatment phase"
11087229|NCT01511640|BG004|Baseline|Total|Total of all reporting groups
11087230|NCT01511640|FG000|Participant Flow|300 mg/Day Pregabalin, Then Placebo|"300 mg/day Pregabalin, then Placebo~150 mg then 0 mg 2x daily for duration of treatment phase"
11087231|NCT01511640|FG001|Participant Flow|Placebo, Then 300 mg/Day Pregabalin|"Placebo, then 300 mg/day Pregabalin~0 mg then 150 mg 2x daily for duration of treatment phase"
11087232|NCT01511640|FG002|Participant Flow|450 mg/Day Pregabalin, Then Placebo|"450 mg/day Pregabalin, then Placebo~225 mg then 0 mg 2x daily for duration of treatment phase"
11087233|NCT01511640|FG003|Participant Flow|Placebo, Then 450 mg/Day Pregabalin|"Placebo, then 450 mg/day Pregabalin~0 mg then 225 mg 2x daily for duration of treatment phase"
11087234|NCT01511640|OG000|Outcome|300 mg/Day Pregabalin|"Cannabis choice during 300 mg/day Pregabalin maintenance~Placebo (0% THC) and Active (5.9% THC) Cannabis~Pregabalin 300 mg/day"
11087235|NCT01511640|OG001|Outcome|0 mg/Day Pregabalin (Placebo 1)|"Cannabis choice during 0 mg/day Pregabalin maintenance~Placebo (0% THC) and Active (5.9% THC) Cannabis~Pregabalin 0 mg/day (comparator for 300 mg/day)"
11087236|NCT01511640|OG002|Outcome|450 mg/Day Pregabalin|"Cannabis choice during 450 mg/day Pregabalin maintenance~Placebo (0% THC) and Active (5.9% THC) Cannabis~Pregabalin 450 mg/day"
11087237|NCT01511640|OG003|Outcome|0 mg/Day Pregabalin (Placebo 2)|"Cannabis choice during 0 mg/day Pregabalin maintenance~Placebo (0% THC) and Active (5.9% THC) Cannabis~Pregabalin 0 mg/day (comparator for 450 mg/day)"
11087238|NCT01511640|EG000|Reported Event|300 mg/Day Pregabalin|"Cannabis choice during 300 mg/day Pregabalin maintenance~Placebo (0% THC) and Active (5.9% THC) Cannabis"
11087239|NCT01511640|EG001|Reported Event|0 mg/Day Pregabalin (Placebo 1)|"Cannabis choice during 0 mg/day Pregabalin maintenance (placebo comparator for 300 mg/day group)~Placebo (0% THC) and Active (5.9% THC) Cannabis"
11087240|NCT01511640|EG002|Reported Event|450 mg/Day PregabalinPregabalin|"Cannabis choice during 450 mg/day Pregabalin maintenance~Placebo (0% THC) and Active (5.9% THC) Cannabis"
11087241|NCT01511640|EG003|Reported Event|0 mg/Day Pregabalin (Placebo 2)|"Cannabis choice during 0 mg/day Pregabalin maintenance (placebo comparator for 450 mg/day group)~Placebo (0% THC) and Active (5.9% THC) Cannabis"
11087242|NCT01511809|BG000|Baseline|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
11087243|NCT01511809|BG001|Baseline|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
11087244|NCT01511809|BG002|Baseline|Total|Total of all reporting groups
11087245|NCT01511809|FG000|Participant Flow|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
11087246|NCT01511809|FG001|Participant Flow|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
11087247|NCT01511809|OG000|Outcome|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
11087248|NCT01511809|OG001|Outcome|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
11087249|NCT01511809|EG000|Reported Event|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
11087250|NCT01511809|EG001|Reported Event|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
11087251|NCT01511939|BG000|Baseline|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087252|NCT01511939|BG001|Baseline|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087253|NCT01511939|BG002|Baseline|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087254|NCT01511939|BG003|Baseline|Total|Total of all reporting groups
11087255|NCT01511939|FG000|Participant Flow|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis (OA) pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087256|NCT01511939|FG001|Participant Flow|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087257|NCT01511939|FG002|Participant Flow|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087258|NCT01511939|OG000|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087259|NCT01511939|OG001|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087260|NCT01511939|OG002|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087261|NCT01511939|EG000|Reported Event|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087262|NCT01511939|EG001|Reported Event|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087263|NCT01511939|EG002|Reported Event|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
11087264|NCT01511978|BG000|Baseline|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were administered their usual dosage on their regular personalized schedule
11087265|NCT01511978|BG001|Baseline|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
11087266|NCT01511978|BG002|Baseline|Total|Total of all reporting groups
11087267|NCT01511978|FG000|Participant Flow|Continuous 3,4-DAP|Subjects were administered their usual dosage on their regular personalized schedule
11087268|NCT01511978|FG001|Participant Flow|Taper 3,4-DAP to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
11087269|NCT01511978|OG000|Outcome|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were continued on their usual pre-randomization 3,4-DAP dosing regimen.
11087270|NCT01511978|OG001|Outcome|3,4-DAP Taper to Placebo|Subjects were tapered off of their pre-randomization 3,4-DAP dosing regimen over 3 days with up to an additional 16 hours of placebo.
11087271|NCT01511978|OG000|Outcome|3,4-DAP|Subjects were administered their usual dosage on their regular personalized schedule.
11087272|NCT01511978|OG001|Outcome|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
11087273|NCT01511978|EG000|Reported Event|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were administered their usual dosage on their regular personalized schedule
11087274|NCT01511978|EG001|Reported Event|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
11233826|NCT02431260|EG001|Reported Event|Part 1 / Treatment Group A: 22.5 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11087275|NCT01512108|BG000|Baseline|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
11087276|NCT01512108|BG001|Baseline|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling.
11087277|NCT01512108|BG002|Baseline|Total|Total of all reporting groups
11087278|NCT01512108|FG000|Participant Flow|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
11087279|NCT01512108|FG001|Participant Flow|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling.
11087280|NCT01512108|OG000|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
11087281|NCT01512108|OG001|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling.
11087282|NCT01512108|EG000|Reported Event|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
11087283|NCT01512108|EG001|Reported Event|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling.
11087284|NCT01512160|BG000|Baseline|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087285|NCT01512160|BG001|Baseline|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087286|NCT01512160|BG002|Baseline|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087287|NCT01512160|BG003|Baseline|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087288|NCT01512160|BG004|Baseline|Total|Total of all reporting groups
11087289|NCT01512160|FG000|Participant Flow|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).
11087290|NCT01512160|FG001|Participant Flow|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087291|NCT01512160|FG002|Participant Flow|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087292|NCT01512160|FG003|Participant Flow|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087293|NCT01512160|OG000|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087294|NCT01512160|OG001|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11233827|NCT02431260|EG002|Reported Event|Part 1 / Treatment Group A: 15 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11087295|NCT01512160|OG002|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087296|NCT01512160|OG003|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087297|NCT01512160|OG000|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087298|NCT01512160|EG000|Reported Event|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087299|NCT01512160|EG001|Reported Event|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087300|NCT01512160|EG002|Reported Event|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087301|NCT01512160|EG003|Reported Event|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
11087302|NCT01512225|BG000|Baseline|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
11087303|NCT01512225|BG001|Baseline|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
11087304|NCT01512225|BG002|Baseline|Total|Total of all reporting groups
11087305|NCT01512225|FG000|Participant Flow|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
11087306|NCT01512225|FG001|Participant Flow|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
11087307|NCT01512225|OG000|Outcome|Group A: Domperidone|Domperidone 10 mg orally three times daily for 28 days
11087308|NCT01512225|OG001|Outcome|Group B: Placebo + Domperidone|Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
11087309|NCT01512225|OG000|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
11087310|NCT01512225|OG001|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
11087311|NCT01512225|EG000|Reported Event|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
11087312|NCT01512225|EG001|Reported Event|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
11087313|NCT01512251|BG000|Baseline|Vemurafenib-Naïve|
11087314|NCT01512251|BG001|Baseline|Vemurafenib-Resistant|
11087315|NCT01512251|BG002|Baseline|Total|Total of all reporting groups
11087316|NCT01512251|FG000|Participant Flow|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
11087317|NCT01512251|FG001|Participant Flow|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
11233828|NCT02431260|EG003|Reported Event|Part 1 / Treatment Group A: 30 MG QD INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11087318|NCT01512251|OG000|Outcome|Determination of MTD|"Vemurafenib-Naïve and Vemurafenib-Resistant populations received:~150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid"
11087319|NCT01512251|OG000|Outcome|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
11087320|NCT01512251|OG001|Outcome|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
11087321|NCT01512251|EG000|Reported Event|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
11087322|NCT01512251|EG001|Reported Event|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
11087323|NCT01512264|BG000|Baseline|rTMS|"3 weeks of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087324|NCT01512264|BG001|Baseline|1 Week of Sham Treatment + 2 Weeks of nerTMS|"1 week of Sham Treatment + 2 weeks of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087325|NCT01512264|BG002|Baseline|2 Weeks of Sham Treatment +1 Week of nerTMS|"2 weeks of Sham Treatment +1 week of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11228044|NCT02387970|FG000|Participant Flow|Immediate Provisionalization|"Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery~Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.~NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.~Dental crown: A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
11087326|NCT01512264|BG003|Baseline|Control Group|"3 weeks of Sham Treatment~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087327|NCT01512264|BG004|Baseline|Total|Total of all reporting groups
11087328|NCT01512264|FG000|Participant Flow|rTMS|"3 weeks of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087329|NCT01512264|FG001|Participant Flow|1 Week of Sham Treatment + 2 Weeks of nerTMS|"1 week of Sham Treatment + 2 weeks of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087330|NCT01512264|FG002|Participant Flow|2 Weeks of Sham Treatment +1 Week of nerTMS|"2 weeks of Sham Treatment +1 week of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087331|NCT01512264|FG003|Participant Flow|Control Group|"3 weeks of Sham Treatment~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087332|NCT01512264|OG000|Outcome|rTMS|"3 weeks of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087333|NCT01512264|OG001|Outcome|1 Week of Sham Treatment + 2 Weeks of nerTMS|"1 week of Sham Treatment + 2 weeks of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087334|NCT01512264|OG002|Outcome|2 Weeks of Sham Treatment +1 Week of nerTMS|"2 weeks of Sham Treatment +1 week of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087335|NCT01512264|OG003|Outcome|Control Group|"3 weeks of Sham Treatment~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087336|NCT01512264|EG000|Reported Event|rTMS|"3 weeks of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11233829|NCT02431260|EG004|Reported Event|Part 1 / Treatment Group A: 22.5 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11233830|NCT02431260|EG005|Reported Event|Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329|"Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.~Treatment Group A included any advanced solid tumor or lymphoma."
11087337|NCT01512264|EG001|Reported Event|1 Week of Sham Treatment + 2 Weeks of nerTMS|"1 week of Sham Treatment + 2 weeks of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087338|NCT01512264|EG002|Reported Event|2 Weeks of Sham Treatment +1 Week of nerTMS|"2 weeks of Sham Treatment +1 week of nerTMS~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087339|NCT01512264|EG003|Reported Event|Control Group|"3 weeks of Sham Treatment~Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery."
11087340|NCT01512368|BG000|Baseline|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
11087341|NCT01512368|FG000|Participant Flow|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
11087342|NCT01512368|OG000|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
11087343|NCT01512368|EG000|Reported Event|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
11087344|NCT01512446|BG000|Baseline|Placebo|Placebo, administered orally once weekly
11087345|NCT01512446|BG001|Baseline|Alendronate|Alendronate 70 mg, administered orally once weekly
11087346|NCT01512446|BG002|Baseline|Total|Total of all reporting groups
11087347|NCT01512446|FG000|Participant Flow|Placebo|Placebo, administered orally once weekly
11087348|NCT01512446|FG001|Participant Flow|Alendronate|Alendronate 70 mg, administered orally once weekly
11087349|NCT01512446|OG000|Outcome|Placebo|Placebo, administered orally once weekly
11087350|NCT01512446|OG001|Outcome|Alendronate|Alendronate 70 mg, administered orally once weekly
11087351|NCT01512446|EG000|Reported Event|Placebo|Placebo, administered orally once weekly
11087352|NCT01512446|EG001|Reported Event|Alendronate|Alendronate 70 mg, administered orally once weekly
11087353|NCT01512667|BG000|Baseline|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
11087354|NCT01512667|BG001|Baseline|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
11087355|NCT01512667|BG002|Baseline|Total|Total of all reporting groups
11087356|NCT01512667|FG000|Participant Flow|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
11087357|NCT01512667|FG001|Participant Flow|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
11087358|NCT01512667|OG000|Outcome|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
11087359|NCT01512667|OG001|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
11087360|NCT01512667|EG000|Reported Event|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
11087361|NCT01512667|EG001|Reported Event|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
11087362|NCT01512693|BG000|Baseline|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
11087363|NCT01512693|BG001|Baseline|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
11087364|NCT01512693|BG002|Baseline|Total|Total of all reporting groups
11087365|NCT01512693|FG000|Participant Flow|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
11087366|NCT01512693|FG001|Participant Flow|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
11087367|NCT01512693|OG000|Outcome|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
11087368|NCT01512693|OG001|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
11087369|NCT01512693|EG000|Reported Event|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
11087370|NCT01512693|EG001|Reported Event|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
11087371|NCT01512745|BG000|Baseline|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
11087372|NCT01512745|BG001|Baseline|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
11087373|NCT01512745|BG002|Baseline|Total|Total of all reporting groups
11087374|NCT01512745|FG000|Participant Flow|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
11087375|NCT01512745|FG001|Participant Flow|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
11087376|NCT01512745|OG000|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
11087377|NCT01512745|OG001|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
11087378|NCT01512745|EG000|Reported Event|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
11087379|NCT01512745|EG001|Reported Event|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
11087380|NCT01512758|BG000|Baseline|Alisertib 30 mg|Alisertib 30 mg enteric-coated tablets (ECT), orally, twice a day (BID) for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 16 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2.
11087381|NCT01512758|BG001|Baseline|Alisertib 40 mg|Alisertib 40 mg ECT, orally, BID for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 7 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2.
11087382|NCT01512758|BG002|Baseline|Total|Total of all reporting groups
11087383|NCT01512758|FG000|Participant Flow|Alisertib 30 mg|Alisertib 30 mg enteric-coated tablets (ECT), orally, twice a day (BID) for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 16 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2.
11087384|NCT01512758|FG001|Participant Flow|Alisertib 40 mg|Alisertib 40 mg ECT, orally, BID for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 7 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2.
11087385|NCT01512758|OG000|Outcome|Alisertib 30 mg or 40 mg|Alisertib 30 mg or 40 mg enteric-coated tablets, orally, twice a day (BID) on Days 1 through 7, followed by a 14-day rest period, in a 21-day cycle (28-day cycle with additional 7-day rest period if all alisertib-related toxicities [except alopecia] were not resolved to less than Grade 2), for a maximum of 24 months or until there is evidence of disease progression or unacceptable treatment related toxicity (up to 16 cycles).
11087386|NCT01512758|OG000|Outcome|Alisertib 30 mg|Alisertib 30 mg enteric-coated tablets (ECT), orally, twice a day (BID) for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 16 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2.
11233831|NCT02431260|EG006|Reported Event|Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11087387|NCT01512758|OG001|Outcome|Alisertib 40 mg|Alisertib 40 mg ECT, orally, BID for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 7 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2.
11087388|NCT01512758|EG000|Reported Event|Alisertib 30 mg|Alisertib 30 mg enteric-coated tablets (ECT), orally, twice a day (BID) for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 16 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2.
11087389|NCT01512758|EG001|Reported Event|Alisertib 40 mg|Alisertib 40 mg ECT, orally, BID for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 7 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2.
11087390|NCT01512797|BG000|Baseline|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
11087391|NCT01512797|BG001|Baseline|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
11087392|NCT01512797|BG002|Baseline|Total|Total of all reporting groups
11087393|NCT01512797|FG000|Participant Flow|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
11087394|NCT01512797|FG001|Participant Flow|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
11087395|NCT01512797|OG000|Outcome|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
11087396|NCT01512797|OG001|Outcome|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
11087397|NCT01512797|EG000|Reported Event|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
11087398|NCT01512797|EG001|Reported Event|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
11087399|NCT01512849|BG000|Baseline|Entire Population for Moderate Renal Impairment|
11087400|NCT01512849|BG001|Baseline|Entire Population for Normal Renal Function|
11087401|NCT01512849|BG002|Baseline|Total|Total of all reporting groups
11087402|NCT01512849|FG000|Participant Flow|Moderate Renal Impairment Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
11087403|NCT01512849|FG001|Participant Flow|Moderate Renal Impairment High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
11087404|NCT01512849|FG002|Participant Flow|Normal Renal Function Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
11087405|NCT01512849|FG003|Participant Flow|Normal Renal Function High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
11087406|NCT01512849|OG000|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
11087407|NCT01512849|OG001|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
11228045|NCT02387970|FG001|Participant Flow|Delayed Provisionalization|"Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery~Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.~NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.~Dental crown: A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
11233832|NCT02431260|EG007|Reported Event|Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11087408|NCT01512849|OG002|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
11087409|NCT01512849|OG003|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
11087410|NCT01512849|EG000|Reported Event|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
11087411|NCT01512849|EG001|Reported Event|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
11087412|NCT01512849|EG002|Reported Event|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
11087413|NCT01512849|EG003|Reported Event|Normal Renal Function High|TA-7284-High was administered in a single dose.
10851388|NCT00306202|OG001|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
11087414|NCT01512979|BG000|Baseline|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
11087415|NCT01512979|BG001|Baseline|Linagliptin 5mg|Patients treated with linagliptin 5mg
11087416|NCT01512979|BG002|Baseline|Total|Total of all reporting groups
11087417|NCT01512979|FG000|Participant Flow|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
11087418|NCT01512979|FG001|Participant Flow|Linagliptin 5mg|Patients treated with linagliptin 5mg
11087419|NCT01512979|OG000|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
11087420|NCT01512979|OG001|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
11087421|NCT01512979|EG000|Reported Event|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
11087422|NCT01512979|EG001|Reported Event|Linagliptin 5mg|Patients treated with linagliptin 5mg
11087423|NCT01513122|BG000|Baseline|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
11087424|NCT01513122|BG001|Baseline|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
11087425|NCT01513122|BG002|Baseline|Total|Total of all reporting groups
11087426|NCT01513122|FG000|Participant Flow|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
11087427|NCT01513122|FG001|Participant Flow|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
11087428|NCT01513122|OG000|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
11087429|NCT01513122|OG001|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
11087430|NCT01513122|EG000|Reported Event|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
11087431|NCT01513122|EG001|Reported Event|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
11087432|NCT01513148|BG000|Baseline|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
11087433|NCT01513148|BG001|Baseline|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
11087434|NCT01513148|BG002|Baseline|Total|Total of all reporting groups
11087435|NCT01513148|FG000|Participant Flow|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
11087436|NCT01513148|FG001|Participant Flow|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
11087437|NCT01513148|OG000|Outcome|Light NCV Pretreatment|NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve
11087438|NCT01513148|OG001|Outcome|Light NCV Time 0|NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
11087439|NCT01513148|OG002|Outcome|Light NCV Time 2|NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
11087440|NCT01513148|OG003|Outcome|Light NCV Time 4|NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
11087441|NCT01513148|OG004|Outcome|Light NCV Time 6|NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
11087442|NCT01513148|OG005|Outcome|Light NCV Time 8|NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
11087443|NCT01513148|OG006|Outcome|Light NCV Time 10|NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
11087444|NCT01513148|OG007|Outcome|Sham NCV Pretreatment|NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve
11087445|NCT01513148|OG008|Outcome|Sham NCV Time 0|NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve
11087446|NCT01513148|OG009|Outcome|Sham NCV Time 2|NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
11087447|NCT01513148|OG010|Outcome|Sham NCV Time 4|NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
11087448|NCT01513148|OG011|Outcome|Sham NCV Time 6|NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
11087449|NCT01513148|OG012|Outcome|Sham NCV Time 8|NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
11087450|NCT01513148|OG013|Outcome|Sham NCV Time 10|NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
11087451|NCT01513148|OG000|Outcome|Light NPL Pre-treatment|NPL for treatment group (Superluminous diode light therapy) at baseline (pre-treatment)
11087452|NCT01513148|OG001|Outcome|Light NPL Time 0|NPL for treatment group (Superluminous diode light therapy) at time 0 minutes
11087453|NCT01513148|OG002|Outcome|Light NPL Time 2|NPL for treatment group (Superluminous diode light therapy) at time 2 minutes
11087454|NCT01513148|OG003|Outcome|Light NPL Time 4|NPL for treatment group (Superluminous diode light therapy) at time 4 minutes
11087455|NCT01513148|OG004|Outcome|Light NPL Time 6|NPL for treatment group (Superluminous diode light therapy) at time 6 minutes
11087456|NCT01513148|OG005|Outcome|Light NPL Time 8|NPL for treatment group (Superluminous diode light therapy) at time 8 minutes
11087457|NCT01513148|OG006|Outcome|Light NPL Time 10|NPL for treatment group (Superluminous diode light therapy) at time 10 minutes
11087458|NCT01513148|OG007|Outcome|Sham NPL Time 0|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 0 minutes
11087459|NCT01513148|OG008|Outcome|Sham NPL Time 2|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 2 minutes
11087460|NCT01513148|OG009|Outcome|Sham NPL Time 4|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 4 minutes
11087461|NCT01513148|OG010|Outcome|Sham NPL Time 6|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 6 minutes
11087462|NCT01513148|OG011|Outcome|Sham NPL Time 8|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 8 minutes
11087463|NCT01513148|OG012|Outcome|Sham NPL Time 10|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 10 minutes
11087464|NCT01513148|OG013|Outcome|Sham NPL Pretreatment|NPL for Sham treatment group (Sham Superluminous diode light therapy) at baseline (pretreatment)
11087465|NCT01513148|OG000|Outcome|Light Temp Pretreatment|Temperature prior to the application of super luminous diodes light irradiation over the superficial radial nerve
11087466|NCT01513148|OG001|Outcome|Light Temp Time 0|Temperature immediately following the application of superluminous diodes light irradiation over the superficial radial nerve
11087467|NCT01513148|OG002|Outcome|Light Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087468|NCT01513148|OG003|Outcome|Light Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087469|NCT01513148|OG004|Outcome|Light Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087470|NCT01513148|OG005|Outcome|Light Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087471|NCT01513148|OG006|Outcome|Light Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087472|NCT01513148|OG007|Outcome|Sham Temp Pretreatment|Temperature prior to the application of sham super luminous diodes light irradiation over the superficial radial nerve
11087473|NCT01513148|OG008|Outcome|Sham Temp Time 0|Temperature immediately following the application of sham superluminous diodes light irradiation over the superficial radial nerve
11087474|NCT01513148|OG009|Outcome|Sham Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087475|NCT01513148|OG010|Outcome|Sham Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087476|NCT01513148|OG011|Outcome|Sham Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087477|NCT01513148|OG012|Outcome|Sham Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087478|NCT01513148|OG013|Outcome|Sham Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
11087479|NCT01513148|EG000|Reported Event|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
11087480|NCT01513148|EG001|Reported Event|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
11087481|NCT01513239|BG000|Baseline|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
11087482|NCT01513239|BG001|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
11087483|NCT01513239|BG002|Baseline|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
11087484|NCT01513239|BG003|Baseline|Total|Total of all reporting groups
11087485|NCT01513239|FG000|Participant Flow|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
11087486|NCT01513239|FG001|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
11087487|NCT01513239|FG002|Participant Flow|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
11087488|NCT01513239|FG003|Participant Flow|MK-3415A + SOC 9-ME|9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC
11087489|NCT01513239|FG004|Participant Flow|MK-6072 + SOC 9-ME|9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC
11087490|NCT01513239|FG005|Participant Flow|Placebo + SOC 9-ME|9-ME for participants treated with Placebo
11087491|NCT01513239|OG000|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
11087492|NCT01513239|OG001|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
11087493|NCT01513239|OG002|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
11087494|NCT01513239|EG000|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
11087495|NCT01513239|EG001|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
11087496|NCT01513239|EG002|Reported Event|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
11087497|NCT01513239|EG003|Reported Event|MK-3415 + SOC|Single IV infusion of 10 mg/kg MK-3415 + SOC for CDI
11087498|NCT01513239|EG004|Reported Event|MK-3415A + SOC 9-ME|9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC
11087499|NCT01513239|EG005|Reported Event|MK-6072 + SOC 9-ME|9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC
11087500|NCT01513239|EG006|Reported Event|Placebo + SOC 9-ME|9-ME for participants treated with Placebo
11087501|NCT01513291|BG000|Baseline|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
11087502|NCT01513291|BG001|Baseline|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
11087503|NCT01513291|BG002|Baseline|Total|Total of all reporting groups
11087504|NCT01513291|FG000|Participant Flow|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
11087505|NCT01513291|FG001|Participant Flow|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
11087506|NCT01513291|FG002|Participant Flow|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
11087507|NCT01513291|FG003|Participant Flow|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
11087508|NCT01513291|FG004|Participant Flow|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
11087509|NCT01513291|OG000|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
11087510|NCT01513291|OG001|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
11087511|NCT01513291|OG002|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
11087512|NCT01513291|OG003|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
11087513|NCT01513291|OG004|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
11087514|NCT01513291|EG000|Reported Event|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
11087515|NCT01513291|EG001|Reported Event|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
11087516|NCT01513291|EG002|Reported Event|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
11087517|NCT01513291|EG003|Reported Event|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
11087518|NCT01513291|EG004|Reported Event|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
11087519|NCT01513317|BG000|Baseline|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
11087520|NCT01513317|BG001|Baseline|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
11087521|NCT01513317|BG002|Baseline|Total|Total of all reporting groups
11087522|NCT01513317|FG000|Participant Flow|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
11087523|NCT01513317|FG001|Participant Flow|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
11087524|NCT01513317|OG000|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
11087525|NCT01513317|OG001|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
11087526|NCT01513317|EG000|Reported Event|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
11087527|NCT01513317|EG001|Reported Event|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
11087528|NCT01513330|BG000|Baseline|Entire Study Population|Entire study population = all participants enrolled in the study
11087529|NCT01513330|FG000|Participant Flow|First SenSura Mio, Then Standard Care|The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
11087530|NCT01513330|FG001|Participant Flow|First Standard Care, Then SenSura Mio|The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags.
11087531|NCT01513330|OG000|Outcome|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
11087532|NCT01513330|OG001|Outcome|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
11087533|NCT01513330|EG000|Reported Event|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
11087534|NCT01513330|EG001|Reported Event|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
11087535|NCT01513447|BG000|Baseline|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
11087536|NCT01513447|BG001|Baseline|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
11087537|NCT01513447|BG002|Baseline|Total|Total of all reporting groups
11087538|NCT01513447|FG000|Participant Flow|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
11087539|NCT01513447|FG001|Participant Flow|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
11087540|NCT01513447|OG000|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
11173715|NCT02017093|OG000|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.~Error Enhancement: Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
11173716|NCT02017093|OG001|Outcome|Control Group|"Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.~control treatment: Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
11173717|NCT02017093|EG000|Reported Event|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
11173718|NCT02017093|EG001|Reported Event|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
11173719|NCT02017171|BG000|Baseline|Allopurinol|Oral allopurinol at a dose of 100 mg per day for 4 weeks and then at a dose ranging from 200 to 400 mg per day depending on kidney function
11173720|NCT02017171|BG001|Baseline|Placebo|Oral placebo tablets (Inactive oral tablets identical in appearance to allopurinol tablets)
11087541|NCT01513447|OG001|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
11087542|NCT01513447|EG000|Reported Event|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
11087543|NCT01513447|EG001|Reported Event|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
11087544|NCT01513460|BG000|Baseline|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087545|NCT01513460|BG001|Baseline|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087546|NCT01513460|BG002|Baseline|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087547|NCT01513460|BG003|Baseline|Total|Total of all reporting groups
11087548|NCT01513460|FG000|Participant Flow|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087549|NCT01513460|FG001|Participant Flow|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087550|NCT01513460|FG002|Participant Flow|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087551|NCT01513460|OG000|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087552|NCT01513460|OG001|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087553|NCT01513460|OG000|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087554|NCT01513460|OG001|Outcome|NVA237/Tiotropium+Flu/Sal|NVA237+Flu/Sal and Tiotropium+Flu/Sal arms
11173721|NCT02017171|BG002|Baseline|Total|Total of all reporting groups
11173722|NCT02017171|FG000|Participant Flow|Allopurinol|Oral allopurinol at a dose of 100 mg per day for 4 weeks and then at a dose ranging from 200 to 400 mg per day depending on kidney function
11087555|NCT01513460|OG002|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087556|NCT01513460|EG000|Reported Event|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087557|NCT01513460|EG001|Reported Event|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087558|NCT01513460|EG002|Reported Event|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
11087559|NCT01513473|BG000|Baseline|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
11087560|NCT01513473|BG001|Baseline|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
11087561|NCT01513473|BG002|Baseline|Total|Total of all reporting groups
11087562|NCT01513473|FG000|Participant Flow|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
11087563|NCT01513473|FG001|Participant Flow|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
11087564|NCT01513473|OG000|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
11087565|NCT01513473|OG001|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
11087566|NCT01513473|EG000|Reported Event|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
11087567|NCT01513473|EG001|Reported Event|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
11087568|NCT01513538|BG000|Baseline|TherapyGuide|"Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function~TherapyGuide: Use of TherapyGuide function to help programming the device"
11087569|NCT01513538|FG000|Participant Flow|Patients Implanted With a Dual Chamber Pacemaker|All the enrolled patients were patients implanted with a dual chamber pacemaker with the Therapy Guide application : one-arm study.
11087570|NCT01513538|OG000|Outcome|Patients Implanted With a Dual Chamber Pacemaker|All the patients were implanted with a dual chamber pacemaker with Therapy Guide function : one-arm study.
11087571|NCT01513538|EG000|Reported Event|Patients Implanted With a Dual Chamber Pacemaker|All the patients were implanted with a dual chamber pacemaker with Therapy Guide function : one-arm study.
11087572|NCT01513551|BG000|Baseline|V114|Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
11233833|NCT02431260|EG008|Reported Event|Part 1 / Treatment Group A: 20 MG BID INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
11087573|NCT01513551|BG001|Baseline|PNEUMOVAX® 23|Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
11087574|NCT01513551|BG002|Baseline|PREVNAR 13®|Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
11087575|NCT01513551|BG003|Baseline|Total|Total of all reporting groups
11087576|NCT01513551|FG000|Participant Flow|V114|Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
11087577|NCT01513551|FG001|Participant Flow|PNEUMOVAX® 23|Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
11087578|NCT01513551|FG002|Participant Flow|PREVNAR 13®|Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
11087579|NCT01513551|OG000|Outcome|V114|Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
11087580|NCT01513551|OG001|Outcome|PNEUMOVAX® 23|Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
11087581|NCT01513551|OG002|Outcome|PREVNAR 13®|Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
11087582|NCT01513551|EG000|Reported Event|V114|Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
11087583|NCT01513551|EG001|Reported Event|PNEUMOVAX® 23|Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
11087584|NCT01513551|EG002|Reported Event|PREVNAR 13®|Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
11087585|NCT01513590|BG000|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
11087586|NCT01513590|BG001|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
11087587|NCT01513590|BG002|Baseline|Total|Total of all reporting groups
11087588|NCT01513590|FG000|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
11087589|NCT01513590|FG001|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
11087590|NCT01513590|OG000|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
11087591|NCT01513590|OG001|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
11087592|NCT01513590|EG000|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
11087593|NCT01513590|EG001|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
11087594|NCT01513759|BG000|Baseline|EkoSonic® Endovascular System|Participants received a total of 24 mg of r-tPA infusion at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
11087595|NCT01513759|FG000|Participant Flow|EkoSonic® Endovascular System|Participants received a total of 24 milligrams (mg) of recombinant tissue plasminogen activator (r-tPA) infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral pulmonary embolism [PE]) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
11087596|NCT01513759|OG000|Outcome|EkoSonic® Endovascular System|Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
11087597|NCT01513759|EG000|Reported Event|EkoSonic® Endovascular System|Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
11087598|NCT01513902|BG000|Baseline|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
11087599|NCT01513902|BG001|Baseline|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
11087600|NCT01513902|BG002|Baseline|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
11087601|NCT01513902|BG003|Baseline|Total|Total of all reporting groups
11087602|NCT01513902|FG000|Participant Flow|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
11087603|NCT01513902|FG001|Participant Flow|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
11087604|NCT01513902|FG002|Participant Flow|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
11087605|NCT01513902|OG000|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
11087606|NCT01513902|OG001|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
11087607|NCT01513902|OG002|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
11087608|NCT01513902|EG000|Reported Event|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
11087609|NCT01513902|EG001|Reported Event|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
11087610|NCT01513902|EG002|Reported Event|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
11087611|NCT01513967|BG000|Baseline|Part A, SAD Treatment 1 (5mg)|"RPh201 single dose (SAD 5mg)~RPh201, botanical drug product: SC administration at varying doses"
11087612|NCT01513967|BG001|Baseline|Part A, SAD Treatment 2 (10mg)|"RPh201 single dose (SAD 10mg)~RPh201, botanical drug product: SC administration at varying doses"
11087613|NCT01513967|BG002|Baseline|Part A, SAD Treatment 3 (20mg)|"RPh201 single dose (SAD 20mg)~RPh201, botanical drug product: SC administration at varying doses"
11087614|NCT01513967|BG003|Baseline|Part A, SAD Placebo|"Placebo single dose (SAD)~Placebo: SC administration at varying doses"
11087615|NCT01513967|BG004|Baseline|Part B, MAD Treatment 1 (5mg)|"RPh201 multiple dose (MAD 5mg)~RPh201, botanical drug product: SC administration at varying doses"
11087616|NCT01513967|BG005|Baseline|Part B, MAD Treatment 2 (10mg)|"RPh201 multiple dose (MAD 10mg)~RPh201, botanical drug product: SC administration at varying doses"
11087617|NCT01513967|BG006|Baseline|Part B, MAD Treatment 3 (20mg)|"RPh201 multiple dose (MAD 20mg)~RPh201, botanical drug product: SC administration at varying doses"
11087618|NCT01513967|BG007|Baseline|Part B, MAD Placebo|"Placebo multiple dose (MAD)~Placebo: SC administration at varying doses"
11087619|NCT01513967|BG008|Baseline|Total|Total of all reporting groups
11087620|NCT01513967|FG000|Participant Flow|Part A, SAD Treatment 1 5mg|"RPh201 single dose (SAD 5mg)~RPh201, botanical drug product: SC administration at varying doses"
11087621|NCT01513967|FG001|Participant Flow|Part A, SAD Treatment 2|"RPh201 single dose (SAD 10mg)~RPh201, botanical drug product: SC administration at varying doses"
11087622|NCT01513967|FG002|Participant Flow|Part A, SAD Treatment 3|"RPh201 single dose (SAD 20mg)~RPh201, botanical drug product: SC administration at varying doses"
11087623|NCT01513967|FG003|Participant Flow|Part A, SAD Placebo|"Placebo single dose (SAD 20mg)~Placebo: SC administration at varying doses"
11087624|NCT01513967|FG004|Participant Flow|Part B, MAD Treatment 1|"RPh201 multiple dose (MAD 5mg)~RPh201, botanical drug product: SC administration at varying doses"
11087625|NCT01513967|FG005|Participant Flow|Part B, MAD Treatment 2|"RPh201 multiple dose (MAD 10mg)~RPh201, botanical drug product: SC administration at varying doses"
11087626|NCT01513967|FG006|Participant Flow|Part B, MAD Treatment 3|"RPh201 multiple dose (MAD 20mg)~RPh201, botanical drug product: SC administration at varying doses"
11087627|NCT01513967|FG007|Participant Flow|Part B, MAD Placebo|"Placebo multiple dose (MAD 20mg)~Placebo: SC administration at varying doses"
11087628|NCT01513967|OG000|Outcome|Part A, SAD Treatment 5mg|"RPh201 single dose (SAD Low Dose )~RPh201, botanical drug product: SC administration at varying doses"
11087629|NCT01513967|OG001|Outcome|Part A, SAD Treatment 10mg|"RPh201 single dose (SAD Mid Dose )~RPh201, botanical drug product: SC administration at varying doses"
11087630|NCT01513967|OG002|Outcome|Part A, SAD Treatment 20mg|"RPh201 single dose (SAD High Dose )~RPh201, botanical drug product: SC administration at varying doses"
11087631|NCT01513967|OG003|Outcome|Part A, SAD Placebo|"Placebo single dose (SAD High Dose )~Placebo: SC administration at varying doses"
11087632|NCT01513967|OG004|Outcome|Part B, MAD Treatment 5mg|"RPh201 multiple dose (MAD Low Dose )~RPh201, botanical drug product: SC administration at varying doses"
11087633|NCT01513967|OG005|Outcome|Part B, MAD Treatment 10mg|"RPh201 multiple dose (MAD Mid Dose )~RPh201, botanical drug product: SC administration at varying doses"
11087634|NCT01513967|OG006|Outcome|Part B, MAD Treatment 20mg|"RPh201 multiple dose (MAD High Dose )~RPh201, botanical drug product: SC administration at varying doses"
11087635|NCT01513967|OG007|Outcome|Part B, MAD Placebo|"Placebo multiple dose (MAD High Dose )~Placebo: SC administration at varying doses"
11087636|NCT01513967|EG000|Reported Event|Part A, SAD Treatment 1 (5mg)|"RPh201 single dose (SAD 5mg)~RPh201, botanical drug product: SC administration at varying doses"
11087637|NCT01513967|EG001|Reported Event|Part A, SAD Treatment 2 (10mg)|"RPh201 single dose (SAD 10mg)~RPh201, botanical drug product: SC administration at varying doses"
11087638|NCT01513967|EG002|Reported Event|Part A, SAD Treatment 3 (20mg)|"RPh201 single dose (SAD 20mg)~RPh201, botanical drug product: SC administration at varying doses"
11087639|NCT01513967|EG003|Reported Event|Part A, SAD Placebo|"Placebo single dose (SAD)~Placebo: SC administration at varying doses"
11087640|NCT01513967|EG004|Reported Event|Part B, MAD Treatment 1 (5mg)|"RPh201 multiple dose (MAD 5mg)~RPh201, botanical drug product: SC administration at varying doses"
11087641|NCT01513967|EG005|Reported Event|Part B, MAD Treatment 2 (10mg)|"RPh201 multiple dose (MAD 10mg)~RPh201, botanical drug product: SC administration at varying doses"
11087642|NCT01513967|EG006|Reported Event|Part B, MAD Treatment 3 (20mg)|"RPh201 multiple dose (MAD 20mg)~RPh201, botanical drug product: SC administration at varying doses"
11087643|NCT01513967|EG007|Reported Event|Part B, MAD Placebo|"Placebo multiple dose (MAD)~Placebo: SC administration at varying doses"
11087644|NCT01514136|BG000|Baseline|Convex Product Users|Subjects who usually use a convex product
11087645|NCT01514136|BG001|Baseline|Flat Product Users|Subjects who usually use a flat product
11087646|NCT01514136|BG002|Baseline|Total|Total of all reporting groups
11087647|NCT01514136|FG000|Participant Flow|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test A was a newly developed concept by Coloplast A/S for the first round."
11087648|NCT01514136|FG001|Participant Flow|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test B was a newly developed concept by Coloplast A/S for the first round."
11087649|NCT01514136|FG002|Participant Flow|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test C was a newly developed concept by Coloplast A/S for the first round."
11087650|NCT01514136|FG003|Participant Flow|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test D was a newly developed concept by Coloplast A/S for the first round."
11087651|NCT01514136|FG004|Participant Flow|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
11087652|NCT01514136|FG005|Participant Flow|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
11087653|NCT01514136|FG006|Participant Flow|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
11087654|NCT01514136|FG007|Participant Flow|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
11087655|NCT01514136|OG000|Outcome|Test A - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A was a newly developed concept by Coloplast A/S for the first round."
11087656|NCT01514136|OG001|Outcome|Test B - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B was a newly developed concept by Coloplast A/S for the first round."
11087657|NCT01514136|OG002|Outcome|Test C - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C was a newly developed concept by Coloplast A/S for the first round."
11087658|NCT01514136|OG003|Outcome|Test D - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D was a newly developed concept by Coloplast A/S for the first round."
11087659|NCT01514136|OG004|Outcome|Test A* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
11173723|NCT02017171|FG001|Participant Flow|Placebo|Oral placebo tablets (Inactive oral tablets identical in appearance to allopurinol tablets)
11173724|NCT02017171|OG000|Outcome|Allopurinol|Oral allopurinol at a dose of 100 mg per day for 4 weeks and then at a dose ranging from 200 to 400 mg per day depending on kidney function
11087660|NCT01514136|OG005|Outcome|Test B* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
11087661|NCT01514136|OG006|Outcome|Test C* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
11087662|NCT01514136|OG007|Outcome|Test D* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
11087663|NCT01514136|OG008|Outcome|Test A - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A was a newly developed concept by Coloplast A/S for the first round."
11087664|NCT01514136|OG009|Outcome|Test B - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B was a newly developed concept by Coloplast A/S for the first round."
11087665|NCT01514136|OG010|Outcome|Test C - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C was a newly developed concept by Coloplast A/S for the first round."
11087666|NCT01514136|OG011|Outcome|Test D - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D was a newly developed concept by Coloplast A/S for the first round."
11087667|NCT01514136|OG012|Outcome|Test A* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
11087668|NCT01514136|OG013|Outcome|Test B* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
11087669|NCT01514136|OG014|Outcome|Test C* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
11087670|NCT01514136|OG015|Outcome|Test D* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
11087671|NCT01514136|EG000|Reported Event|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test A was a newly developed concept by Coloplast A/S for the first round."
11087672|NCT01514136|EG001|Reported Event|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test B was a newly developed concept by Coloplast A/S for the first round."
11087673|NCT01514136|EG002|Reported Event|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test C was a newly developed concept by Coloplast A/S for the first round."
11087674|NCT01514136|EG003|Reported Event|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test D was a newly developed concept by Coloplast A/S for the first round."
11087675|NCT01514136|EG004|Reported Event|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
11087676|NCT01514136|EG005|Reported Event|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
11087677|NCT01514136|EG006|Reported Event|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
11087678|NCT01514136|EG007|Reported Event|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
11087679|NCT01514149|BG000|Baseline|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
11087680|NCT01514149|BG001|Baseline|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
11087681|NCT01514149|BG002|Baseline|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
11087682|NCT01514149|BG003|Baseline|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
11087683|NCT01514149|BG004|Baseline|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
11087684|NCT01514149|BG005|Baseline|Total|Total of all reporting groups
11087685|NCT01514149|FG000|Participant Flow|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
11087686|NCT01514149|FG001|Participant Flow|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
11087687|NCT01514149|FG002|Participant Flow|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
11087688|NCT01514149|FG003|Participant Flow|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
11087689|NCT01514149|FG004|Participant Flow|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
11087690|NCT01514149|OG000|Outcome|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
11087691|NCT01514149|OG001|Outcome|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
11087692|NCT01514149|OG002|Outcome|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
11087693|NCT01514149|OG003|Outcome|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
11087694|NCT01514149|OG004|Outcome|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
11087695|NCT01514149|EG000|Reported Event|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
11087696|NCT01514149|EG001|Reported Event|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
11087697|NCT01514149|EG002|Reported Event|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
11087698|NCT01514149|EG003|Reported Event|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
11087699|NCT01514149|EG004|Reported Event|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
11087700|NCT01514162|BG000|Baseline|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
11087701|NCT01514162|FG000|Participant Flow|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
11087702|NCT01514162|OG000|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
11087703|NCT01514162|EG000|Reported Event|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
11087704|NCT01514201|BG000|Baseline|Phase I, Dose Level 1 (50 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087705|NCT01514201|BG001|Baseline|Phase I, Dose Level 2 (65 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11173725|NCT02017171|OG001|Outcome|Placebo|Oral placebo tablets (inactive oral tablets identical in appearance to allopurinol tablets).
11173726|NCT02017171|OG001|Outcome|Placebo|Oral placebo tablets (Inactive oral tablets identical in appearance to allopurinol tablets)
11173727|NCT02017171|EG000|Reported Event|Allopurinol|Oral allopurinol at a dose of 100 mg per day for 4 weeks and then at a dose ranging from 200 to 400 mg per day depending on kidney function
11173728|NCT02017171|EG001|Reported Event|Placebo|Oral placebo tablets (Inactive oral tablets identical in appearance to allopurinol tablets)
11087706|NCT01514201|BG002|Baseline|Phase I, Dose Level 3 (85 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087707|NCT01514201|BG003|Baseline|Phase II (MTD)|"Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated."
11087708|NCT01514201|BG004|Baseline|Total|Total of all reporting groups
11087709|NCT01514201|FG000|Participant Flow|Phase I, Dose Level 1 (50 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087710|NCT01514201|FG001|Participant Flow|Phase I, Dose Level 2 (65 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087711|NCT01514201|FG002|Participant Flow|Phase I, Dose Level 3 (85 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087712|NCT01514201|FG003|Participant Flow|Phase II (MTD)|"Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated."
11087713|NCT01514201|OG000|Outcome|Phase I Patients|The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
11087714|NCT01514201|OG000|Outcome|Dose Level 1 (135 mg/m2)|Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 135 mg/m2/day)
11087715|NCT01514201|OG001|Outcome|Dose Level 2 (175 mg/m2)|Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
11087716|NCT01514201|OG002|Outcome|Dose Level 3 (200 mg/m2)|Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
11173729|NCT02017210|BG000|Baseline|Lean/Normal Weight|Individuals with body mass index (BMI)<25 kg/m^2 in the baseline study
11173730|NCT02017210|BG001|Baseline|Overweight/Obese Insulin-Sensitive|Individuals with BMI>25 kg/m^2 who were deemed insulin-sensitive at the baseline study
11173731|NCT02017210|BG002|Baseline|Overweight/Obese Insulin-Resistant|Individuals with BMI>25 kg/m^2 who were deemed insulin-resistant at the baseline study
11173732|NCT02017210|BG003|Baseline|Total|Total of all reporting groups
11087717|NCT01514201|OG000|Outcome|Phase II Patients + Phase I MTD Patients|Phase II patients were those enrolled after the maximum tolerated dose was established in the phase I portion of this trial. Six patients enrolled as phase I patients but who were treated with the established maximum tolerated dose of 65 mg/m2/day twice a day (BID) were also considered phase II patients. There were 53 eligible phase II patients (including the latter six patients). Fifty (50) of these patients were evaluable for outcome analyses as 1 patient withdrew prior to beginning protocol therapy and 2 other patients did not receive adequate study drug to be evaluable for efficacy. To be evaluable for assessing overall survival, patients had to receive at least one dose of Veliparib.
11087718|NCT01514201|OG000|Outcome|Phase I, Dose Level 1 (50 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087719|NCT01514201|OG001|Outcome|Phase I, Dose Level 2 (65 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087720|NCT01514201|OG002|Outcome|Phase I, Dose Level 3 (85 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087721|NCT01514201|OG000|Outcome|Phase II Patients + Phase I MTD Patients|Phase II patients were those enrolled after the maximum tolerated dose was established in the phase I portion of this trial. Six patients enrolled as phase I patients but who were treated with the established maximum tolerated dose of 65 mg/m2/day twice a day (BID) were also considered phase II patients. There were 53 eligible phase II patients (including the latter six patients). Fifty (50) of these patients were evaluable for outcome analyses as 1 patient withdrew prior to beginning protocol therapy and 2 other patients did not receive adequate study drug to be evaluable for efficacy. To be evaluable for assessing PFS, patients had to receive at least one dose of Veliparib.
11087722|NCT01514201|OG003|Outcome|Phase II (MTD)|"Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated."
11087723|NCT01514201|OG000|Outcome|Phase I, Dose Level 1 (50 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087724|NCT01514201|OG001|Outcome|Phase I, Dose Level 2 (65 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11173733|NCT02017210|FG000|Participant Flow|Lean/Normal Weight|Individuals with BMI < 25 kg/m^2
11173734|NCT02017210|FG001|Participant Flow|Overweight/Obese Insulin-Sensitive|Individuals with BMI > 25 kg/m^2 were categorised as Overweight/Obese Insulin-Sensitive if their M/I value was above the median M/I value for each gender
11173735|NCT02017210|FG002|Participant Flow|Overweight/Obese Insulin-Resistant|Individuals with BMI > 25 kg/m^2 were categorised as Overweight/Obese Insulin-Resistant if their M/I were below the median M/I value for each gender
11087725|NCT01514201|OG002|Outcome|Phase I, Dose Level 3 (85 mg)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087726|NCT01514201|OG003|Outcome|Phase II (MTD)|"Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated."
11087727|NCT01514201|EG000|Reported Event|Phase I, Dose Level 1 (50 mg/m2)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087728|NCT01514201|EG001|Reported Event|Phase I, Dose Level 2 (65 mg/m2)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087729|NCT01514201|EG002|Reported Event|Phase I, Dose Level 3 (85 mg/m2)|"Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated."
11087730|NCT01514201|EG003|Reported Event|Phase II (MTD)|"Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.~Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated."
11087731|NCT01514240|BG000|Baseline|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
11087732|NCT01514240|BG001|Baseline|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
11087733|NCT01514240|BG002|Baseline|Total|Total of all reporting groups
11087734|NCT01514240|FG000|Participant Flow|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
11087735|NCT01514240|FG001|Participant Flow|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
11087736|NCT01514240|OG000|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
11087737|NCT01514240|OG001|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
11087738|NCT01514240|EG000|Reported Event|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
11087739|NCT01514240|EG001|Reported Event|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
11087740|NCT01514279|BG000|Baseline|HealthyCHANGE|"Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.~HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
11087741|NCT01514279|BG001|Baseline|SystemCHANGE|"Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines~SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
11087742|NCT01514279|BG002|Baseline|Tools4CHANGE|In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
11087743|NCT01514279|BG003|Baseline|Total|Total of all reporting groups
11087744|NCT01514279|FG000|Participant Flow|HealthyCHANGE|"Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.~HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
11087745|NCT01514279|FG001|Participant Flow|SystemCHANGE|"Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines~SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
11087746|NCT01514279|FG002|Participant Flow|Tools4CHANGE|In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
11087747|NCT01514279|OG000|Outcome|HealthyCHANGE|"Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.~HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
11087748|NCT01514279|OG001|Outcome|SystemCHANGE|"Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines~SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
11087749|NCT01514279|OG002|Outcome|Tools4CHANGE|In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
11087750|NCT01514279|EG000|Reported Event|HealthyCHANGE|"Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.~HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
11087751|NCT01514279|EG001|Reported Event|SystemCHANGE|"Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines~SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
11087752|NCT01514279|EG002|Reported Event|Tools4CHANGE|In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
11087753|NCT01514292|BG000|Baseline|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring(CGM) System Wearing for up to 7 days.
11087754|NCT01514292|FG000|Participant Flow|CGM Device|Dexcom CGM Device Wearing for up to 7 days
11087755|NCT01514292|OG000|Outcome|Real Time Continous Glucose Monitoring System|Real Time Continous Glucose Monitoring System Wearing for up to 7 days
11087756|NCT01514292|EG000|Reported Event|CGM Device|Dexcom CGM Device Wearing for up to 7 days
11087757|NCT01514318|BG000|Baseline|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
11087758|NCT01514318|FG000|Participant Flow|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
11087759|NCT01514318|OG000|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
11087760|NCT01514318|EG000|Reported Event|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
11087761|NCT01514357|BG000|Baseline|Nesiritide (BNP)|Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
11087762|NCT01514357|BG001|Baseline|Placebo|Subjects will receive SQ placebo bid for seven consecutive days.
11087763|NCT01514357|BG002|Baseline|Total|Total of all reporting groups
11173736|NCT02017210|OG000|Outcome|Lean/Normal Weight|Individuals with BMI<25 kg/m2 at the baseline study
11087764|NCT01514357|FG000|Participant Flow|Nesiritide (BNP)|Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
11087765|NCT01514357|FG001|Participant Flow|Placebo|Subjects will receive SQ placebo bid for seven consecutive days.
11087766|NCT01514357|OG000|Outcome|Nesiritide (BNP)|Subjects will receive subcutaneous (SQ) Nesiritide (BNP) bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
11087767|NCT01514357|OG001|Outcome|Placebo|Subjects will receive SQ placebo bid for seven consecutive days.
11087768|NCT01514357|EG000|Reported Event|Nesiritide (BNP)|Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
11087769|NCT01514357|EG001|Reported Event|Placebo|Subjects will receive SQ placebo bid for seven consecutive days.
11087770|NCT01514370|BG000|Baseline|IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)|Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
11087771|NCT01514370|BG001|Baseline|IFN Beta 1a 44 mcg TIW + Placebo|Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
11087772|NCT01514370|BG002|Baseline|Total|Total of all reporting groups
11087773|NCT01514370|FG000|Participant Flow|IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)|Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
11087774|NCT01514370|FG001|Participant Flow|IFN Beta 1a 44 mcg TIW + Placebo|Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
11087775|NCT01514370|OG000|Outcome|IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)|Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
11087776|NCT01514370|OG001|Outcome|IFN Beta 1a 44 mcg TIW + Placebo|Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
11087777|NCT01514370|OG000|Outcome|IFN Beta 1a 44 mcg TIW + [Curcumin (BCM95) and Placebo]|Subjects received 500 milligram (mg) curcumin or placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for 24 months.
11087778|NCT01514370|EG000|Reported Event|IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)|Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
11087779|NCT01514370|EG001|Reported Event|IFN Beta 1a 44 mcg TIW + Placebo|Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
11087780|NCT01514383|BG000|Baseline|Octylseal|
11087781|NCT01514383|FG000|Participant Flow|Surgical Adhesive|Cyanoacrylate (Octylseal ): surgical adhesive
11087782|NCT01514383|OG000|Outcome|Wound Length Closure of Paticipants Treated With Octylseal|
11087783|NCT01514383|OG000|Outcome|No Pain Reported|Wong-Baker FACES™ Pain Rating Scale Pain Rating Scale from 0-10, with 0 =No Hurt to 10=Hurts Worst
11087784|NCT01514383|EG000|Reported Event|Octylseal|
11087785|NCT01514396|BG000|Baseline|Surgical Glue|"Surgiseal~Surgiseal: surgical glue"
11087786|NCT01514396|FG000|Participant Flow|Surgical Glue|"Surgiseal~Surgiseal: surgical glue To determine if SurgiSeal™ can effectively seal epidermal wounds in children while not causing any adverse events."
11087787|NCT01514396|OG000|Outcome|Wound Closure|Number of Participants with Wound Closure baseline to 14 days from discharge
11087788|NCT01514396|OG000|Outcome|Adverse Events Related to Wound Closure|Adverse Events related to wound closure with study product
11087789|NCT01514396|EG000|Reported Event|Surgical Glue|"Surgiseal~Surgiseal: surgical glue"
11087790|NCT01514422|BG000|Baseline|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
11087791|NCT01514422|FG000|Participant Flow|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
11087792|NCT01514422|OG000|Outcome|Minocycline|Minocycline for 8 weeks
11087793|NCT01514422|EG000|Reported Event|Minocycline|Minocycline for 8 weeks
11087794|NCT01514448|BG000|Baseline|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
11087795|NCT01514448|BG001|Baseline|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
11087796|NCT01514448|BG002|Baseline|Total|Total of all reporting groups
11087797|NCT01514448|FG000|Participant Flow|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
11087798|NCT01514448|FG001|Participant Flow|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
11087799|NCT01514448|OG000|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
11087800|NCT01514448|OG001|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
11087801|NCT01514448|EG000|Reported Event|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
11087802|NCT01514448|EG001|Reported Event|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
11087803|NCT01514448|EG002|Reported Event|Everolimus All Patients|Everolimus - All Patients that failed 1st line SUN and 1st Line PAZ and was on Everolimus 10mg orally once daily
11087804|NCT01514461|BG000|Baseline|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087805|NCT01514461|BG001|Baseline|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087806|NCT01514461|BG002|Baseline|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087807|NCT01514461|BG003|Baseline|Total|Total of all reporting groups
11087808|NCT01514461|FG000|Participant Flow|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087809|NCT01514461|FG001|Participant Flow|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087810|NCT01514461|FG002|Participant Flow|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087811|NCT01514461|OG000|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087812|NCT01514461|OG001|Outcome|LCQ908 20mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087813|NCT01514461|OG002|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087814|NCT01514461|OG001|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087815|NCT01514461|OG000|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087816|NCT01514461|OG001|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087817|NCT01514461|EG000|Reported Event|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087818|NCT01514461|EG001|Reported Event|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary.
11087819|NCT01514461|EG002|Reported Event|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
11087820|NCT01514513|BG000|Baseline|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
11087821|NCT01514513|BG001|Baseline|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
11087822|NCT01514513|BG002|Baseline|Total|Total of all reporting groups
11087823|NCT01514513|FG000|Participant Flow|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
11087824|NCT01514513|FG001|Participant Flow|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
11087825|NCT01514513|OG000|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
11087826|NCT01514513|OG001|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
11087827|NCT01514513|EG000|Reported Event|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
11087828|NCT01514513|EG001|Reported Event|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
11087829|NCT01514630|BG000|Baseline|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
11087830|NCT01514630|FG000|Participant Flow|Creatine Monohydrate|14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks. Participants were seen twice weekly after creatine was initiated. All participants met SCID-I/P criteria for lifetime methamphetamine dependence or for current methamphetamine dependence. After consent was obtained, the principal investigator administered the SCID-I/P and HAMD, and if a female met SCID-I/P criteria and scored > 15 on the HAMD, the following additional screening data were collected: Beck Anxiety Inventory, C-SSRS , vital signs, concomitant medications, self-report drug use over the past 48 hours for cigarettes, alcohol, cocaine, methamphetamine, marijuana, heroin and prescription controlled substances, urine drug screen for methamphetamine, opiates, benzodiazepines, marijuana and cocaine, pregnancy testing and attendance in outpatient treatment and/or 12 step programs.
11087831|NCT01514630|OG000|Outcome|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
11087832|NCT01514630|EG000|Reported Event|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
11087833|NCT01514734|BG000|Baseline|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
11087834|NCT01514734|FG000|Participant Flow|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
11087835|NCT01514734|OG000|Outcome|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
11087836|NCT01514734|EG000|Reported Event|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
11087837|NCT01514760|BG000|Baseline|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
11173737|NCT02017210|OG001|Outcome|Overweight/Obese Insulin-Sensitive|Individuals with BMI>25 kg/m2 who were deemed insulin-sensitive at the baseline study
11173738|NCT02017210|OG002|Outcome|Overweight/Obese Insulin-Resistant|Individuals with BMI>25 kg/m2 who were deemed insulin-resistant at the baseline study
11173739|NCT02017210|OG000|Outcome|Lean|The Lean group included all individuals with BMI < 25 kg/m2
11173740|NCT02017210|OG001|Outcome|Overweight/Obese Insulin-Sensitive|Those with BMI > 25 kg/m2 were categorised as Overweight/Obese Insulin-Sensitive if their M/I value was above the median M/I value for each gender
11173741|NCT02017210|OG002|Outcome|Overweight/Obese Insulin-Resistant|Those with BMI > 25 kg/m2 were categorised as Overweight/Obese Insulin-Resistant if their M/I were below the median M/I value for each gender
11173742|NCT02017210|EG000|Reported Event|Lean/Normal Weight|Individuals with BMI < 25 kg/m2
11087838|NCT01514760|FG000|Participant Flow|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan : The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
11087839|NCT01514760|OG000|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
11087840|NCT01514760|EG000|Reported Event|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
11087841|NCT01514786|BG000|Baseline|Control|Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
11087842|NCT01514786|BG001|Baseline|Intervention With Colorectal Website|"Intervention website includes an interactive component including preferences and risk assessment.~Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS"
11087843|NCT01514786|BG002|Baseline|Total|Total of all reporting groups
11087844|NCT01514786|FG000|Participant Flow|Control|Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
11087845|NCT01514786|FG001|Participant Flow|Intervention With Colorectal Website|"Intervention website includes an interactive component including preferences and risk assessment.~Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS"
11087846|NCT01514786|OG000|Outcome|Control|Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
11087847|NCT01514786|OG001|Outcome|Intervention With Colorectal Website|"Intervention website includes an interactive component including preferences and risk assessment.~Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS"
11087848|NCT01514786|EG000|Reported Event|Control|Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
11087849|NCT01514786|EG001|Reported Event|Intervention With Colorectal Website|"Intervention website includes an interactive component including preferences and risk assessment.~Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS"
11087850|NCT01514864|BG000|Baseline|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
11233834|NCT02431260|EG009|Reported Event|Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11087851|NCT01514864|BG001|Baseline|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
11087852|NCT01514864|BG002|Baseline|Total|Total of all reporting groups
11087853|NCT01514864|FG000|Participant Flow|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
11087854|NCT01514864|FG001|Participant Flow|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
11087855|NCT01514864|OG000|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
11087856|NCT01514864|OG001|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
11087857|NCT01514864|OG000|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
11087858|NCT01514864|OG000|Outcome|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer (NSCLC) received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
11087859|NCT01514864|EG000|Reported Event|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
11087860|NCT01515046|BG000|Baseline|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
11087861|NCT01515046|FG000|Participant Flow|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
11087862|NCT01515046|OG000|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
11087863|NCT01515046|EG000|Reported Event|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
11087864|NCT01515072|BG000|Baseline|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
11087865|NCT01515072|BG001|Baseline|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
11087866|NCT01515072|BG002|Baseline|Total|Total of all reporting groups
11087867|NCT01515072|FG000|Participant Flow|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
11173743|NCT02017210|EG001|Reported Event|Overweight/Obese Insulin-Sensitive|Those with BMI > 25 kg/m2 were categorised as Overweight/Obese Insulin-Sensitive if their M/I value was above the median M/I value for each gender
11173744|NCT02017210|EG002|Reported Event|Overweight/Obese Insulin-Resistant|Those with BMI > 25 kg/m2 were categorised as Overweight/Obese Insulin-Resistant if their M/I were below the median M/I value for each gender
11173745|NCT02017223|BG000|Baseline|Pre-post Test Design|10 participants wore an accelerometer for a weekend. Within two weeks, the same 10 participants wore KNOWME sensors, carried the KNOWME phone and wore an accelerometer.
11173746|NCT02017223|FG000|Participant Flow|Pre-post Test Design|10 participants wore an accelerometer for a weekend. Within two weeks, the same 10 participants wore KNOWME sensors, carried the KNOWME phone and wore an accelerometer.
11173747|NCT02017223|OG000|Outcome|Pre-post Test Design|10 participants wore an accelerometer for a weekend. Within two weeks, the same 10 participants wore KNOWME sensors, carried the KNOWME phone and wore an accelerometer.
11173748|NCT02017223|EG000|Reported Event|Knowme Device Wear|Knowme Device Wear and use of mobile phone - one-armed, no control group, pre-post design
11173749|NCT02017327|BG000|Baseline|Monoprost|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis."
11173750|NCT02017327|BG001|Baseline|Lumigan 0.01%|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Lumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container."
11087868|NCT01515072|FG001|Participant Flow|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
11087869|NCT01515072|OG000|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
11087870|NCT01515072|OG001|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
11087871|NCT01515072|OG000|Outcome|No RIPC|"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.~Any discrepancy in the number of participants is attributed to missing data for some participants"
11087872|NCT01515072|OG001|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first occurs immediately after brain death declaration and consent for organ donation. The second one immediately before of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention occurs at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.~Any discrepancy in the number of participants is attributed to missing data for some participants"
11087873|NCT01515072|OG000|Outcome|No RIPC|"Kidneys in this group were recovered from donors in the No RIPC arm. Decisions regarding which kidneys were not and were pumped were made by the OPO.~Any discrepancy in the number of participants is attributed to missing data for some subjects."
11087874|NCT01515072|OG001|Outcome|RIPC|"Kidneys in this group were recovered from donors in the RIPC arm. Decisions regarding which kidneys were not and were pumped were made by the OPO.~Any discrepancy in the number of participants is attributed to missing data for some subjects."
11087875|NCT01515072|OG000|Outcome|No Remote Ischemic Preconditioning|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
11087876|NCT01515072|OG001|Outcome|Remote Ischemic Preconditioning|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
10851389|NCT00306202|OG002|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2, escalated/dose level 3 of 100 mg/m^2, escalated/dose level 3 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
11087877|NCT01515072|OG000|Outcome|No RIPC|Kidneys in this group were recovered from donors in the No RIPC arm.
11087878|NCT01515072|OG001|Outcome|RIPC|Kidneys in this group were recovered from donors in the RIPC arm.
11087879|NCT01515072|OG000|Outcome|No RIPC|The recipients in this group received one or more organs from donors in the No RIPC arm of the RIPNOD trial.
11087880|NCT01515072|OG001|Outcome|RIPC|The recipients in this group received one or more organs from donors in the RIPC arm of the RIPNOD trial
11087881|NCT01515072|EG000|Reported Event|No RIPC, Kidney Recipients|Recipients in this group received kidneys from donors who did not receive remote ischemic preconditioning (No RIPC group)
11087882|NCT01515072|EG001|Reported Event|RIPC, Kidney Recipients|Recipients in this group received kidneys from donors who received two RIPC interventions
11087883|NCT01515072|EG002|Reported Event|No RIPC, All Organ Recipients|Recipients in this group received organs from donors who did not receive remote ischemic preconditioning (No RIPC)
11087884|NCT01515072|EG003|Reported Event|RIPC, All Organ Recipients|Recipients in this group received organs from donors who received two RIPC interventions
11087885|NCT01515072|EG004|Reported Event|No RIPC, Donors|Donors in this group did not receive remote ischemic preconditioning (RIPC)
11233835|NCT02431260|EG010|Reported Event|Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329|Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
11087886|NCT01515072|EG005|Reported Event|RIPC, Donors|Donors in this group received two RIPC interventions
11087887|NCT01515176|BG000|Baseline|Dose Level I: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
11087888|NCT01515176|BG001|Baseline|Dose Level II:|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
11087889|NCT01515176|BG002|Baseline|Total|Total of all reporting groups
11087890|NCT01515176|FG000|Participant Flow|Dose Level I: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
11087891|NCT01515176|FG001|Participant Flow|Dose Level II: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
11087892|NCT01515176|OG000|Outcome|Treatment (Ofatumumab, Dinaciclib)|"Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.~Dinaciclib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Ofatumumab: Given IV~Pharmacological Study: Correlative studies"
11087893|NCT01515176|OG000|Outcome|Dose Level I: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
11087894|NCT01515176|OG001|Outcome|Dose Level II: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
11087895|NCT01515176|OG000|Outcome|Dose Level I and Dose Level II|"Dose Level I:~Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7.~Dose Level II:~Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity."
11087896|NCT01515176|EG000|Reported Event|Dose Level I: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
11087897|NCT01515176|EG001|Reported Event|Dose Level II: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
11087898|NCT01515189|BG000|Baseline|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
11087899|NCT01515189|BG001|Baseline|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
11087900|NCT01515189|BG002|Baseline|Total|Total of all reporting groups
11087901|NCT01515189|FG000|Participant Flow|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
11087902|NCT01515189|FG001|Participant Flow|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
11087903|NCT01515189|OG000|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
11087904|NCT01515189|OG001|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
11087905|NCT01515189|EG000|Reported Event|10 MG/KG IPILIMUMAB|
11087906|NCT01515189|EG001|Reported Event|3 MG/KG IPILIMUMAB|
11087907|NCT01515319|BG000|Baseline|2mg Y242|Y242 single dose, subcutaneous (Part A)
11087908|NCT01515319|BG001|Baseline|7.5mg Y242|Y242 single dose, subcutaneous (Part A)
11087909|NCT01515319|BG002|Baseline|15mg Y242|Y242 single dose, subcutaneous (Part A)
11087910|NCT01515319|BG003|Baseline|30mg Y242|Y242 single dose, subcutaneous (Part A)
11087911|NCT01515319|BG004|Baseline|60mg Y242|Y242 single dose, subcutaneous (Part A)
11087912|NCT01515319|BG005|Baseline|90mg Y242|Y242 single dose, subcutaneous (Part A)
11087913|NCT01515319|BG006|Baseline|Placebo - Part A|"0.9% saline~0.9% saline: Identical volume to that of Y242"
11087914|NCT01515319|BG007|Baseline|60mg Y242 (B1)|Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
11087915|NCT01515319|BG008|Baseline|90mg Y242 (B2-B4)|Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
11087916|NCT01515319|BG009|Baseline|Placebo - Part B|"0.9% saline~0.9% saline: Identical volume to that of Y242"
11087917|NCT01515319|BG010|Baseline|Total|Total of all reporting groups
11087918|NCT01515319|FG000|Participant Flow|2mg Y242|Y242 single dose, subcutaneous (Part A)
11087919|NCT01515319|FG001|Participant Flow|7.5mg Y242|Y242 single dose, subcutaneous (Part A)
11087920|NCT01515319|FG002|Participant Flow|15mg Y242|Y242 single dose, subcutaneous (Part A)
11087921|NCT01515319|FG003|Participant Flow|30mg Y242|Y242 single dose, subcutaneous (Part A)
11087922|NCT01515319|FG004|Participant Flow|60mg Y242|Y242 single dose, subcutaneous (Part A)
11087923|NCT01515319|FG005|Participant Flow|90mg Y242|Y242 single dose, subcutaneous (Part A)
11087924|NCT01515319|FG006|Participant Flow|Placebo - Part A|"0.9% saline~0.9% saline: Identical volume to that of Y242"
11087925|NCT01515319|FG007|Participant Flow|60mg Y242 (B1)|Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
11087926|NCT01515319|FG008|Participant Flow|90mg Y242 (B2-B4)|Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
11087927|NCT01515319|FG009|Participant Flow|Placebo - Part B|0.9% saline - placebo
11087928|NCT01515319|OG000|Outcome|2mg Y242|Y242 single dose, subcutaneous (Part A)
11087929|NCT01515319|OG001|Outcome|7.5mg Y242|Y242 single dose, subcutaneous (Part A)
11087930|NCT01515319|OG002|Outcome|15mg Y242|Y242 single dose, subcutaneous (Part A)
11087931|NCT01515319|OG003|Outcome|30mg Y242|Y242 single dose, subcutaneous (Part A)
11087932|NCT01515319|OG004|Outcome|60mg Y242|Y242 single dose, subcutaneous (Part A)
11087933|NCT01515319|OG005|Outcome|90mg Y242|Y242 single dose, subcutaneous (Part A)
11087934|NCT01515319|OG006|Outcome|Placebo - Part A|"0.9% saline~0.9% saline: Identical volume to that of Y242"
11087935|NCT01515319|OG007|Outcome|60mg Y242 (B1)|Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
11087936|NCT01515319|OG008|Outcome|90mg Y242 (B2-B4)|Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
11087937|NCT01515319|OG009|Outcome|Placebo - Part B|"0.9% saline~0.9% saline: Identical volume to that of Y242"
11087938|NCT01515319|EG000|Reported Event|2mg Y242|Y242 single dose, subcutaneous (Part A)
11087939|NCT01515319|EG001|Reported Event|7.5mg Y242|Y242 single dose, subcutaneous (Part A)
11087940|NCT01515319|EG002|Reported Event|15mg Y242|Y242 single dose, subcutaneous (Part A)
11087941|NCT01515319|EG003|Reported Event|30mg Y242|Y242 single dose, subcutaneous (Part A)
11087942|NCT01515319|EG004|Reported Event|60mg Y242|Y242 single dose, subcutaneous (Part A)
11087943|NCT01515319|EG005|Reported Event|90mg Y242|Y242 single dose, subcutaneous (Part A)
11087944|NCT01515319|EG006|Reported Event|Placebo - Part A|"0.9% saline~0.9% saline: Identical volume to that of Y242"
11087945|NCT01515319|EG007|Reported Event|60mg Y242 (B1)|Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
11087946|NCT01515319|EG008|Reported Event|90mg Y242 (B2-B4)|Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
11087947|NCT01515319|EG009|Reported Event|Placebo - Part B|"0.9% saline~0.9% saline: Identical volume to that of Y242"
11087948|NCT01515345|BG000|Baseline|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
11087949|NCT01515345|BG001|Baseline|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
11087950|NCT01515345|BG002|Baseline|Total|Total of all reporting groups
11087951|NCT01515345|FG000|Participant Flow|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
11087952|NCT01515345|FG001|Participant Flow|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
11087953|NCT01515345|OG000|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
11087954|NCT01515345|OG001|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
11087955|NCT01515345|EG000|Reported Event|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
11087956|NCT01515345|EG001|Reported Event|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
11087957|NCT01515410|BG000|Baseline|Overall Study|DM-1992 first, then Sinemet IR; Sinemet IR first, then DM-1992
11087958|NCT01515410|FG000|Participant Flow|DM-1992 First, Then Sinemet IR|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) first, then Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
11087959|NCT01515410|FG001|Participant Flow|Sinemet IR First, Then DM-1992|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) first, then DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
11087960|NCT01515410|OG000|Outcome|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
11087961|NCT01515410|OG001|Outcome|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
11087962|NCT01515410|EG000|Reported Event|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
11087963|NCT01515410|EG001|Reported Event|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
11087964|NCT01515423|BG000|Baseline|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
11087965|NCT01515423|BG001|Baseline|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
11087966|NCT01515423|BG002|Baseline|Total|Total of all reporting groups
11087967|NCT01515423|FG000|Participant Flow|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
11087968|NCT01515423|FG001|Participant Flow|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
11087969|NCT01515423|FG002|Participant Flow|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
11087970|NCT01515423|OG000|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
11087971|NCT01515423|OG001|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
11087972|NCT01515423|EG000|Reported Event|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
11087973|NCT01515423|EG001|Reported Event|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
11087974|NCT01515423|EG002|Reported Event|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
11087975|NCT01515475|BG000|Baseline|Glasses- Older Cohort|"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087976|NCT01515475|BG001|Baseline|Observation- Older Cohort|"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087977|NCT01515475|BG002|Baseline|Glasses- Younger Cohort|"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087978|NCT01515475|BG003|Baseline|Observation- Younger Cohort|"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087979|NCT01515475|BG004|Baseline|Total|Total of all reporting groups
11087980|NCT01515475|FG000|Participant Flow|Glasses- Older Cohort|"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087981|NCT01515475|FG001|Participant Flow|Observation- Older Cohort|"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087982|NCT01515475|FG002|Participant Flow|Glasses- Younger Cohort|"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087983|NCT01515475|FG003|Participant Flow|Observation- Younger Cohort|"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087984|NCT01515475|OG000|Outcome|Glasses- Older Cohort|"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087985|NCT01515475|OG001|Outcome|Observation- Older Cohort|"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087986|NCT01515475|OG002|Outcome|Glasses- Younger Cohort|"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087987|NCT01515475|OG003|Outcome|Observation- Younger Cohort|"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087988|NCT01515475|EG000|Reported Event|Glasses- Older Cohort|"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11335679|NCT03554629|EG006|Reported Event|Salter Lab Oral-Trac (Oral/Nasal)|"8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant.~Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following"
11087989|NCT01515475|EG001|Reported Event|Observation- Older Cohort|"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087990|NCT01515475|EG002|Reported Event|Glasses- Younger Cohort|"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087991|NCT01515475|EG003|Reported Event|Observation- Younger Cohort|"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.~Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion."
11087992|NCT01515488|BG000|Baseline|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
11087993|NCT01515488|BG001|Baseline|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
11087994|NCT01515488|BG002|Baseline|Total|Total of all reporting groups
11087995|NCT01515488|FG000|Participant Flow|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
11087996|NCT01515488|FG001|Participant Flow|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
11087997|NCT01515488|OG000|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
11087998|NCT01515488|OG001|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
11087999|NCT01515488|EG000|Reported Event|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
11088000|NCT01515488|EG001|Reported Event|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
11088001|NCT01515540|BG000|Baseline|Lidocaine|5% lidoderm patch
11088002|NCT01515540|BG001|Baseline|Control|placebo patch
11088003|NCT01515540|BG002|Baseline|Total|Total of all reporting groups
11088004|NCT01515540|FG000|Participant Flow|Lidocaine|5% lidoderm patch
11088005|NCT01515540|FG001|Participant Flow|Control|placebo patch
11088006|NCT01515540|OG000|Outcome|Lidocaine|5% lidoderm patch
11088007|NCT01515540|OG001|Outcome|Control|placebo patch
11088008|NCT01515540|EG000|Reported Event|Lidocaine|5% lidoderm patch
11088009|NCT01515540|EG001|Reported Event|Control|placebo patch
11088010|NCT01515566|BG000|Baseline|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
11088011|NCT01515566|BG001|Baseline|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
11088012|NCT01515566|BG002|Baseline|Total|Total of all reporting groups
11088013|NCT01515566|FG000|Participant Flow|Fentanyl|Fentanyl subcutaneous (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Questionnaires completed at baseline and after study visit.
11088014|NCT01515566|FG001|Participant Flow|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Placebo. Questionnaires completed at baseline and after study visit.
11088015|NCT01515566|OG000|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
11088016|NCT01515566|OG001|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
11088017|NCT01515566|EG000|Reported Event|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl.
11088018|NCT01515566|EG001|Reported Event|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Placebo.
11088019|NCT01515657|BG000|Baseline|All Study Participants|All patients that received at least 1 dose of study drug under the study protocol.
11088020|NCT01515657|FG000|Participant Flow|PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin|"First Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days"
11088021|NCT01515657|FG001|Participant Flow|IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin|"First Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
11088022|NCT01515657|FG002|Participant Flow|EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets|"First Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days"
11088023|NCT01515657|OG000|Outcome|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
11088024|NCT01515657|OG001|Outcome|Immediate-Release Aspirin Tablets|"Active comparator; crossover design~Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
11088025|NCT01515657|OG002|Outcome|Enteric-coated Aspirin Caplets|"Active comparator; crossover design~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
11088026|NCT01515657|EG000|Reported Event|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
11088027|NCT01515657|EG001|Reported Event|Immediate-Release Aspirin Tablets|"Active comparator; crossover design~Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
11088028|NCT01515657|EG002|Reported Event|Enteric-coated Aspirin Caplets|"Active comparator; crossover design~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
11088029|NCT01515696|BG000|Baseline|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
11088030|NCT01515696|BG001|Baseline|Sterile Water|infants receive 9ml/kg sterile water
11088031|NCT01515696|BG002|Baseline|Total|Total of all reporting groups
11088032|NCT01515696|FG000|Participant Flow|Gastrografin|infants received 3ml/kg Gastrografin + 6ml/kg sterile water once during the first 24 hours of life via gastric tube
11088033|NCT01515696|FG001|Participant Flow|Sterile Water|infants received 9ml/kg sterile water once during the first 24 hours of life via gastric tube
11088034|NCT01515696|OG000|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
11088035|NCT01515696|OG001|Outcome|Sterile Water|infants receive 9ml/kg sterile water
11088036|NCT01515696|EG000|Reported Event|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
11088037|NCT01515696|EG001|Reported Event|Sterile Water|infants receive 9ml/kg sterile water
11088038|NCT01515865|BG000|Baseline|Enrolled Population|
11088039|NCT01515865|FG000|Participant Flow|Midodrine HCl - (Open-label)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld. On Day 2, all eligible subjects continued on their midodrine HCl dose regimen over at least 14 days, using study-supplied investigational product.
11088040|NCT01515865|FG001|Participant Flow|Midodrine HCl - (Randomized)|On Day 16 subjects received over-encapsulated midodrine HCl tablets (equivalent to their previously prescribed dose).
11088041|NCT01515865|FG002|Participant Flow|Placebo - (Randomized)|On Day 16 subjects received matching placebo.
11088042|NCT01515865|OG000|Outcome|Midodrine HCl|Over-encapsulated midodrine HCl tablet at the subjects previously prescribed dose level.
11088043|NCT01515865|OG001|Outcome|Placebo|Matching placebo treatment (utilizing the same number of placebo capsules that would be required to constitute their midodrine HCl dose).
11088044|NCT01515865|EG000|Reported Event|Midodrine HCl - Open-label (Part A)|dose at the subjects current dose level
11088045|NCT01515865|EG001|Reported Event|Midodrine HCl - Open-label (Part B)|open-label study-supplied (Part B) dose at subjects current dose level
11088046|NCT01515865|EG002|Reported Event|Midodrine HCl - Randomized (Part C)|over-encapsulated randomized dose (Part C) at subjects current dose level
11088047|NCT01515865|EG003|Reported Event|Placebo - Randomized (Part C)|over-encapsulated randomized matching placebo
11088048|NCT01515891|BG000|Baseline|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
11088049|NCT01515891|FG000|Participant Flow|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
11088050|NCT01515891|OG000|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
11088051|NCT01515891|EG000|Reported Event|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
11088052|NCT01515943|BG000|Baseline|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
11088053|NCT01515943|BG001|Baseline|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the pr"
11088054|NCT01515943|BG002|Baseline|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
11088055|NCT01515943|BG003|Baseline|Total|Total of all reporting groups
11088056|NCT01515943|FG000|Participant Flow|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
11088057|NCT01515943|FG001|Participant Flow|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times."
11088058|NCT01515943|FG002|Participant Flow|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
10851390|NCT00306202|OG000|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
11088059|NCT01515943|OG000|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
11088060|NCT01515943|OG001|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
11088061|NCT01515943|OG002|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
11088062|NCT01515943|OG000|Outcome|HB-C (Completed Computer-based Therapy Program)|Participants in the HB-C treatment group who completed the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving at least 15 stars for the jump vergence exercise).
11088063|NCT01515943|OG001|Outcome|HB-C (Did Not Complete Computer-based Therapy Program)|Participants in the HB-C treatment group who did not complete the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving <15 stars for the jump vergence exercise.
11088064|NCT01515943|EG000|Reported Event|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
11088065|NCT01515943|EG001|Reported Event|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
11088066|NCT01515943|EG002|Reported Event|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
11088067|NCT01515956|BG000|Baseline|BMN110 2.0 mg/kg/Week|2.0 mg/kg/week
11088068|NCT01515956|FG000|Participant Flow|BMN110 2.0 mg/kg/Week|Weekly intravenous infusions of BMN 110 at a dose of 2.0 mg/kg for 52 consecutive weeks. Each infusion will be administered over a period of approximately 4 hours.
11088069|NCT01515956|OG000|Outcome|BMN110 2.0 mg/kg/Week|BMN110 2.0 mg/kg/week
11228046|NCT02387970|OG000|Outcome|Immediate Provisionalization|"Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery~Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.~NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.~Dental crown: A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
11088070|NCT01515956|OG000|Outcome|BMN110 2.0 mg/kg/Week|Weekly intravenous infusions of BMN 110 at a dose of 2.0 mg/kg for 52 consecutive weeks. Each infusion will be administered over a period of approximately 4 hours.
11088071|NCT01515956|EG000|Reported Event|BMN110 2.0 mg/kg/Week|BMN110 2.0 mg/kg/week
11088072|NCT01515995|BG000|Baseline|Magnesium Sulfate Group|"15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Nebulized magnesium sulfate: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Versus~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
11088073|NCT01515995|BG001|Baseline|Normal Saline Group|"15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour~Nebulized magnesium sulfate: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Versus~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
11088074|NCT01515995|BG002|Baseline|Total|Total of all reporting groups
11088075|NCT01515995|FG000|Participant Flow|Magnesium Sulfate Group|"15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Nebulized magnesium sulfate: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Versus~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
11088076|NCT01515995|FG001|Participant Flow|Normal Saline Group|"15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour~Nebulized magnesium sulfate: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Versus~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
11088077|NCT01515995|OG000|Outcome|Magnesium Sulfate Group|"15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Nebulized magnesium sulfate: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Versus~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
11088078|NCT01515995|OG001|Outcome|Normal Saline Group|"15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour~Nebulized magnesium sulfate: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Versus~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
11088079|NCT01515995|EG000|Reported Event|Magnesium Sulfate Group|"15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Nebulized magnesium sulfate: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Versus~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
11088080|NCT01515995|EG001|Reported Event|Normal Saline Group|"15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour~Nebulized magnesium sulfate: 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour~Versus~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
11088081|NCT01516008|BG000|Baseline|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
11088082|NCT01516008|BG001|Baseline|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
11088083|NCT01516008|BG002|Baseline|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
11088084|NCT01516008|BG003|Baseline|Total|Total of all reporting groups
11088085|NCT01516008|FG000|Participant Flow|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
11088086|NCT01516008|FG001|Participant Flow|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
11088087|NCT01516008|FG002|Participant Flow|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
11088088|NCT01516008|OG000|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
11088089|NCT01516008|OG001|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
11088090|NCT01516008|OG002|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
11088091|NCT01516008|EG000|Reported Event|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
11088092|NCT01516008|EG001|Reported Event|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
11088093|NCT01516008|EG002|Reported Event|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
11088094|NCT01516268|BG000|Baseline|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
11088095|NCT01516268|BG001|Baseline|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
10851391|NCT00306202|OG001|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
11088096|NCT01516268|BG002|Baseline|Total|Total of all reporting groups
11335680|NCT03554629|EG007|Reported Event|Medtronic Smart Capnoline+(Oral/Nasal)|"8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant.~Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following"
11088097|NCT01516268|FG000|Participant Flow|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
11088098|NCT01516268|FG001|Participant Flow|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
11088099|NCT01516268|OG000|Outcome|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
11088100|NCT01516268|OG001|Outcome|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
11088101|NCT01516268|EG000|Reported Event|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
11088102|NCT01516268|EG001|Reported Event|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
11088103|NCT01516424|BG000|Baseline|Blonanserin|Participants received 8-24mg tablet orally twice daily for 8 weeks
11088104|NCT01516424|BG001|Baseline|Risperidone|Participants received 2-6mg tablet orally twice daily for 8 weeks
11088105|NCT01516424|BG002|Baseline|Total|Total of all reporting groups
11088106|NCT01516424|FG000|Participant Flow|Blonanserin|"Blonanserin:~Dosage Form: Tablet Dosage and Usage: 8~24mg/d ,b.i.d"
11088107|NCT01516424|FG001|Participant Flow|Risperidone|"Risperidone:~Dosage Form: Tablet Dosage and Usage: 2~6mg/d ,b.i.d"
11088108|NCT01516424|OG000|Outcome|Blonanserin|Participants received 8-24mg tablet orally twice daily for 8 weeks.
11088109|NCT01516424|OG001|Outcome|Risperidone|Participants received 2-6mg tablet orally twice daily for 8 weeks.
11088110|NCT01516424|EG000|Reported Event|Blonanserin|Participants received 8-24mg tablet orally twice daily for 8 weeks
11088111|NCT01516424|EG001|Reported Event|Risperidone|Participants received 2-6mg tablet orally twice daily for 8 weeks
11088112|NCT01516437|BG000|Baseline|HNS Group|Healthy non-smokers aged between 45-75 years
11088113|NCT01516437|BG001|Baseline|HS Group|Healthy smokers aged between 45-75 years
11088114|NCT01516437|BG002|Baseline|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
11088115|NCT01516437|BG003|Baseline|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
11088116|NCT01516437|BG004|Baseline|Total|Total of all reporting groups
11088117|NCT01516437|FG000|Participant Flow|HNS Group|Healthy non-smokers aged between 45-75 years
11088118|NCT01516437|FG001|Participant Flow|HS Group|Healthy smokers aged between 45-75 years
11088119|NCT01516437|FG002|Participant Flow|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
11088120|NCT01516437|FG003|Participant Flow|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
11088121|NCT01516437|OG000|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
11088122|NCT01516437|OG001|Outcome|HS Group|Healthy smokers aged between 45-75 years
11088123|NCT01516437|OG002|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
11088124|NCT01516437|OG003|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
11088125|NCT01516437|OG000|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
11088126|NCT01516437|OG001|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
11088127|NCT01516437|EG000|Reported Event|HNS Group|Healthy non-smokers aged between 45-75 years
11088128|NCT01516437|EG001|Reported Event|HS Group|Healthy smokers aged between 45-75 years
11088129|NCT01516437|EG002|Reported Event|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
11088130|NCT01516437|EG003|Reported Event|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
11173751|NCT02017327|BG002|Baseline|Lumigan 0.03% Unit Dose|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Lumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers."
11173752|NCT02017327|BG003|Baseline|Total|Total of all reporting groups
11088131|NCT01516632|BG000|Baseline|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging-based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
11088132|NCT01516632|BG001|Baseline|The Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one's sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
11088133|NCT01516632|BG002|Baseline|Total|Total of all reporting groups
11088134|NCT01516632|FG000|Participant Flow|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging-based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
11088135|NCT01516632|FG001|Participant Flow|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one's sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
11088136|NCT01516632|OG000|Outcome|Smoking Cesssation Via Text Messaging|"The 6-week smoking cessation program~SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
11088137|NCT01516632|OG001|Outcome|Attention Matched Control|"Messages aimed at improving one's sleep and increasing one's fitness, along with general messages about the most well known health dangers of smoking. Messages sent on the same schedule as the intervention group.~SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
11088138|NCT01516632|OG000|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging-based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
11088139|NCT01516632|OG001|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one's sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
11088140|NCT01516632|EG000|Reported Event|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging-based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
11088141|NCT01516632|EG001|Reported Event|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one's sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
11088142|NCT01516684|BG000|Baseline|Arm A (EMLA)|"Trials completed is the unit of measure, not participants.~Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation"
11088143|NCT01516684|BG001|Baseline|Arm B (Placebo)|"Trials completed is the unit of measure, not participants.~Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation"
11088144|NCT01516684|BG002|Baseline|Total|Total of all reporting groups
11088145|NCT01516684|FG000|Participant Flow|Arm A (EMLA)|Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation
11088146|NCT01516684|FG001|Participant Flow|Arm B (Placebo)|Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation
11088147|NCT01516684|OG000|Outcome|Arm A (EMLA)|Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation
11088148|NCT01516684|OG001|Outcome|Arm B (Placebo)|Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation
11088149|NCT01516684|OG000|Outcome|Arm A (EMLA)|"Trials completed is the unit of measure, not participants.~Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation"
11088150|NCT01516684|OG001|Outcome|Arm B (Placebo)|"Trials completed is the unit of measure, not participants.~Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation"
11088151|NCT01516684|EG000|Reported Event|Arm A (EMLA)|"TRIALS COMPLETED is the unit of measure, not participants.~Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation"
11088152|NCT01516684|EG001|Reported Event|Arm B (Placebo)|"TRIALS COMPLETED is the unit of measure, not participants.~Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation"
11088153|NCT01516736|BG000|Baseline|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
11088154|NCT01516736|BG001|Baseline|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11088155|NCT01516736|BG002|Baseline|Total|Total of all reporting groups
11088156|NCT01516736|FG000|Participant Flow|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
11088157|NCT01516736|FG001|Participant Flow|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11088158|NCT01516736|OG000|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
11088159|NCT01516736|OG001|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11088160|NCT01516736|EG000|Reported Event|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
11088161|NCT01516736|EG001|Reported Event|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
11088162|NCT01516749|BG000|Baseline|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
11088163|NCT01516749|FG000|Participant Flow|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
11228047|NCT02387970|OG001|Outcome|Delayed Provisionalization|"Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery~Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.~NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.~Dental crown: A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
11088164|NCT01516749|OG000|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
11088165|NCT01516749|EG000|Reported Event|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
11088166|NCT01516879|BG000|Baseline|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
11088167|NCT01516879|BG001|Baseline|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
11088168|NCT01516879|BG002|Baseline|Total|Total of all reporting groups
11088169|NCT01516879|FG000|Participant Flow|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
11088170|NCT01516879|FG001|Participant Flow|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
11088171|NCT01516879|OG000|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
11088172|NCT01516879|OG001|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
11088173|NCT01516879|EG000|Reported Event|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
11088174|NCT01516879|EG001|Reported Event|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
11088175|NCT01516892|BG000|Baseline|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
11088176|NCT01516892|FG000|Participant Flow|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
11088177|NCT01516892|OG000|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
11088178|NCT01516892|EG000|Reported Event|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
11088179|NCT01516957|BG000|Baseline|Placebo SC|"Placebo~Placebo: Placebo SC (subcutaneous)"
11088180|NCT01516957|BG001|Baseline|AMG 827 140|"140 mg AMG 827~AMG 827 140: 140 mg AMG 827 SC (subcutaneous)"
11088181|NCT01516957|BG002|Baseline|AMG 827 280|"280 mg AMG 827~AMG 827 280: 280 mg AMG 827 SC (subcutaneous)"
11088182|NCT01516957|BG003|Baseline|Total|Total of all reporting groups
11088183|NCT01516957|FG000|Participant Flow|Placebo SC|"Placebo~Placebo: Placebo SC (subcutaneous)"
11088184|NCT01516957|FG001|Participant Flow|140mg SC|"140 mg AMG 827~AMG 827 140: 140 mg AMG 827 SC (subcutaneous)"
11088185|NCT01516957|FG002|Participant Flow|280mg SC|"280 mg AMG 827~AMG 827 280: 280 mg AMG 827 SC (subcutaneous)"
11088186|NCT01516957|FG003|Participant Flow|Open Label AMG 827 SC 210 or 280 mg|Open label 210 mg or 280 mg AMG 827 SC (subcutaneous), after Week 12.
11088187|NCT01516957|OG000|Outcome|Placebo SC|"Placebo~Placebo: Placebo SC (subcutaneous)"
11088188|NCT01516957|OG001|Outcome|AMG 827 140|"140 mg AMG 827~AMG 827 140: 140 mg AMG 827 SC (subcutaneous)"
11088189|NCT01516957|OG002|Outcome|AMG 827 280|"280 mg AMG 827~AMG 827 280: 280 mg AMG 827 SC (subcutaneous)"
11088190|NCT01516957|EG000|Reported Event|Placebo SC|"Placebo~Placebo: Placebo SC (subcutaneous)"
11088191|NCT01516957|EG001|Reported Event|AMG 827 140|"140 mg AMG 827~AMG 827 140: 140 mg AMG 827 SC (subcutaneous)"
11088192|NCT01516957|EG002|Reported Event|AMG 827 280|"280 mg AMG 827~AMG 827 280: 280 mg AMG 827 SC (subcutaneous)"
11088193|NCT01516957|EG003|Reported Event|Open Label 210 mg or 280 mg AMG 827|Open label 210 mg or 280 mg AMG 827 after Week 12
11088194|NCT01516970|BG000|Baseline|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
11088195|NCT01516970|BG001|Baseline|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
11088196|NCT01516970|BG002|Baseline|Total|Total of all reporting groups
11088197|NCT01516970|FG000|Participant Flow|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
11088198|NCT01516970|FG001|Participant Flow|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
11088199|NCT01516970|OG000|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
11088200|NCT01516970|OG001|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
11088201|NCT01516970|EG000|Reported Event|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
11088202|NCT01516970|EG001|Reported Event|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
11088203|NCT01517074|BG000|Baseline|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
11088204|NCT01517074|FG000|Participant Flow|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
11088205|NCT01517074|OG000|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
11088206|NCT01517074|OG000|Outcome|Study Eye|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
11088207|NCT01517074|OG001|Outcome|Fellow Eye|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
11088208|NCT01517074|OG000|Outcome|Scleral Inflammation Score at Baseline|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
11088209|NCT01517074|OG001|Outcome|Scleral Inflammation Score at Week 52|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
11088210|NCT01517074|OG002|Outcome|Step Changes in Scleral Inflammation at Week 52 From Baseline|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
11088211|NCT01517074|EG000|Reported Event|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
11088212|NCT01517178|BG000|Baseline|Intention-to-treat Analysis Set|
11088213|NCT01517178|FG000|Participant Flow|Standard Care - New Ostomy Base Plate|Subjects first test Standard Care then New ostomy base plate.
11088214|NCT01517178|FG001|Participant Flow|New Ostomy Base Plate - Standard Care|Subjects first test New ostomy base plate then Standard Care.
11088215|NCT01517178|OG000|Outcome|Standard Care Base Plate|
11088216|NCT01517178|OG001|Outcome|New Ostomy Base Plate|
11088217|NCT01517178|EG000|Reported Event|Standard Care Base Plate|Safety population includes subjects allocated to test period (no run-in period)
11088218|NCT01517178|EG001|Reported Event|New Ostomy Base Plate|Safety population includes subjects allocated to run-in period and test period.
11088219|NCT01517282|BG000|Baseline|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088220|NCT01517282|BG001|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088221|NCT01517282|BG002|Baseline|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088222|NCT01517282|BG003|Baseline|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
11088223|NCT01517282|BG004|Baseline|Total|Total of all reporting groups
11088224|NCT01517282|FG000|Participant Flow|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088225|NCT01517282|FG001|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088226|NCT01517282|FG002|Participant Flow|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088227|NCT01517282|FG003|Participant Flow|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
11088228|NCT01517282|OG000|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088229|NCT01517282|OG001|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088230|NCT01517282|OG002|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088231|NCT01517282|OG003|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
11088232|NCT01517282|EG000|Reported Event|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088233|NCT01517282|EG001|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088234|NCT01517282|EG002|Reported Event|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
11088235|NCT01517282|EG003|Reported Event|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
11088236|NCT01517295|BG000|Baseline|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
11088237|NCT01517295|BG001|Baseline|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
11088238|NCT01517295|BG002|Baseline|Total|Total of all reporting groups
11088239|NCT01517295|FG000|Participant Flow|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
11088240|NCT01517295|FG001|Participant Flow|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
11088241|NCT01517295|OG000|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
11088242|NCT01517295|OG001|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
11088243|NCT01517295|EG000|Reported Event|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
11088244|NCT01517295|EG001|Reported Event|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
11088245|NCT01517373|BG000|Baseline|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088246|NCT01517373|BG001|Baseline|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088247|NCT01517373|BG002|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088248|NCT01517373|BG003|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088249|NCT01517373|BG004|Baseline|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088250|NCT01517373|BG005|Baseline|Total|Total of all reporting groups
11088251|NCT01517373|FG000|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
11088252|NCT01517373|FG001|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088253|NCT01517373|FG002|Participant Flow|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088254|NCT01517373|FG003|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088255|NCT01517373|FG004|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088256|NCT01517373|FG005|Participant Flow|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088257|NCT01517373|OG000|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088258|NCT01517373|OG001|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088259|NCT01517373|OG002|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088260|NCT01517373|OG003|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088261|NCT01517373|OG004|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088262|NCT01517373|EG000|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
11088263|NCT01517373|EG001|Reported Event|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088264|NCT01517373|EG002|Reported Event|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088265|NCT01517373|EG003|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088266|NCT01517373|EG004|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088267|NCT01517373|EG005|Reported Event|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
11088268|NCT01517412|BG000|Baseline|Lixisenatide Main Meal|"Lixisenatide 10 mcg SC injection QD within 1 hour before main meal of the day for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin."
11088269|NCT01517412|BG001|Baseline|Lixisenatide Breakfast|"Lixisenatide 10 mcg SC injection QD within 1 hour before breakfast for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin."
11088270|NCT01517412|BG002|Baseline|Total|Total of all reporting groups
11088271|NCT01517412|FG000|Participant Flow|Lixisenatide Main Meal|"Lixisenatide 10 mcg subcutaneous (SC) injection once daily (QD) within 1 hour before main meal of the day for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin."
11088272|NCT01517412|FG001|Participant Flow|Lixisenatide Breakfast|"Lixisenatide 10 mcg SC injection QD within 1 hour before breakfast for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin."
11088273|NCT01517412|OG000|Outcome|Lixisenatide Main Meal|"Lixisenatide 10 mcg SC injection QD within 1 hour before main meal of the day for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin."
11088274|NCT01517412|OG001|Outcome|Lixisenatide Breakfast|"Lixisenatide 10 mcg SC injection QD within 1 hour before breakfast for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin."
11088275|NCT01517412|EG000|Reported Event|Lixisenatide Main Meal|"Lixisenatide 10 mcg SC injection QD within 1 hour before main meal of the day for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin."
11088276|NCT01517412|EG001|Reported Event|Lixisenatide Breakfast|"Lixisenatide 10 mcg SC injection QD within 1 hour before breakfast for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin."
11088277|NCT01517529|BG000|Baseline|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
11088278|NCT01517529|FG000|Participant Flow|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who failed the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
11088279|NCT01517529|OG000|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
11088280|NCT01517529|EG000|Reported Event|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
11088281|NCT01517750|BG000|Baseline|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
11088282|NCT01517750|BG001|Baseline|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
11088283|NCT01517750|BG002|Baseline|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
11088284|NCT01517750|BG003|Baseline|APAP Without Humidification + High Risks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
11088285|NCT01517750|BG004|Baseline|Total|Total of all reporting groups
11088286|NCT01517750|FG000|Participant Flow|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
11088287|NCT01517750|FG001|Participant Flow|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
11088288|NCT01517750|FG002|Participant Flow|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
11088289|NCT01517750|FG003|Participant Flow|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
11088290|NCT01517750|OG000|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
11088291|NCT01517750|OG001|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
11088292|NCT01517750|OG002|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
11088293|NCT01517750|OG003|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
11088294|NCT01517750|OG000|Outcome|Previous ENT Surgeries + Humidification|
11088295|NCT01517750|OG001|Outcome|Previous ENT Surgeries + Without Humidification|
11088296|NCT01517750|OG002|Outcome|Without Previous ENT Surgeries + Humidification|
11088297|NCT01517750|OG003|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
11088298|NCT01517750|EG000|Reported Event|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
11088299|NCT01517750|EG001|Reported Event|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
11088300|NCT01517750|EG002|Reported Event|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
11088301|NCT01517750|EG003|Reported Event|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
11088302|NCT01517867|BG000|Baseline|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
11088303|NCT01517867|BG001|Baseline|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
11088304|NCT01517867|BG002|Baseline|Total|Total of all reporting groups
11088305|NCT01517867|FG000|Participant Flow|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
11088306|NCT01517867|FG001|Participant Flow|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
11088307|NCT01517867|OG000|Outcome|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
11088308|NCT01517867|OG001|Outcome|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
11228048|NCT02387970|EG000|Reported Event|Immediate Provisionalization|"Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery~Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.~NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.~Dental crown: A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
11088309|NCT01517867|EG000|Reported Event|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
11088310|NCT01517867|EG001|Reported Event|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
11088311|NCT01517893|BG000|Baseline|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
11088312|NCT01517893|BG001|Baseline|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
11088313|NCT01517893|BG002|Baseline|Total|Total of all reporting groups
11088314|NCT01517893|FG000|Participant Flow|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
11088315|NCT01517893|FG001|Participant Flow|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
11088316|NCT01517893|OG000|Outcome|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
11088317|NCT01517893|OG001|Outcome|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
11088318|NCT01517893|EG000|Reported Event|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
11088319|NCT01517893|EG001|Reported Event|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
11088320|NCT01517984|BG000|Baseline|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
11088321|NCT01517984|BG001|Baseline|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
11088322|NCT01517984|BG002|Baseline|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
11088323|NCT01517984|BG003|Baseline|Total|Total of all reporting groups
11088324|NCT01517984|FG000|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did receive a living-donor kidney allograft transplant as specified by the protocol.
11088325|NCT01517984|FG001|Participant Flow|Transplanted, Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
11088326|NCT01517984|FG002|Participant Flow|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
11088327|NCT01517984|FG003|Participant Flow|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
11228049|NCT02387970|EG001|Reported Event|Delayed Provisionalization|"Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery~Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.~NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.~Dental crown: A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
11228050|NCT02387983|BG000|Baseline|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
11228051|NCT02387983|FG000|Participant Flow|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
11228052|NCT02387983|OG000|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
11228053|NCT02387983|EG000|Reported Event|MK-5592|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse group) underwent intensive and sparse PK sampling on Days 1 and 8; the next 45 participants (Sparse group) underwent PK sampling on Day 8 only.
11228054|NCT02388074|BG000|Baseline|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
11228055|NCT02388074|FG000|Participant Flow|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
11228056|NCT02388074|OG000|Outcome|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
11228057|NCT02388074|EG000|Reported Event|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
11233836|NCT02431260|EG011|Reported Event|Part 1 / Treatment Group B: 20 MG BID INCB054329|Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
11233837|NCT02431260|EG012|Reported Event|Part 2 / Treatment Group A: 20 MG BID INCB054329|Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
11233838|NCT02431260|EG013|Reported Event|Part 2 / Treatment Group C: 20 mg BID INCB054329|Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
11342297|NCT03704376|FG001|Participant Flow|Adductor Canal Blockade|"Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).~15 ml of 0.2% ropivacaine~100 mcg clonidine~High-frequency linear ultrasound transducer"
11088328|NCT01517984|OG000|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
11088329|NCT01517984|OG001|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
11088330|NCT01517984|EG000|Reported Event|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
11088331|NCT01517984|EG001|Reported Event|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
11088332|NCT01517984|EG002|Reported Event|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
11088333|NCT01518153|BG000|Baseline|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
11088334|NCT01518153|FG000|Participant Flow|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
11088335|NCT01518153|FG001|Participant Flow|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
11173753|NCT02017327|FG000|Participant Flow|Monoprost|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis."
11173754|NCT02017327|FG001|Participant Flow|Lumigan 0.01% (Bimatoprost Eye Drop Solution)|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~3-mL multidose containers"
11173755|NCT02017327|FG002|Participant Flow|Lumigan 0.03% UD (Bimatoprost Eye Drop Solution)|"one drop in each eye once daily at 9.00 pm (± 1 hour) in the inferior conjunctival cul-de-sac from D0 to D84.~0.4-mL single-use low density polyethylene (LDPE) containers."
11173756|NCT02017327|OG000|Outcome|Monoprost|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis."
11173757|NCT02017327|OG001|Outcome|Lumigan 0.01%|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Lumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container."
11088336|NCT01518153|FG002|Participant Flow|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
11088337|NCT01518153|OG000|Outcome|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
11088338|NCT01518153|OG001|Outcome|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
11088339|NCT01518153|OG000|Outcome|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
11088340|NCT01518153|EG000|Reported Event|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
11088341|NCT01518153|EG001|Reported Event|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
11088342|NCT01518153|EG002|Reported Event|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
11092129|NCT01537419|OG001|Outcome|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
11092130|NCT01537419|EG000|Reported Event|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
11228058|NCT02388165|BG000|Baseline|Staphylococcus Aureus 4-antigen (SA4Ag)|Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
11228059|NCT02388165|BG001|Baseline|Placebo|Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
11228060|NCT02388165|BG002|Baseline|Total|Total of all reporting groups
11228061|NCT02388165|FG000|Participant Flow|Staphylococcus Aureus 4-antigen (SA4Ag)|Participants randomized to SA4Ag received a single dose of 0.5 milliliter (mL) SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
11088343|NCT01518192|BG000|Baseline|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.~Evaluations:~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
11088344|NCT01518192|BG001|Baseline|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.~Evaluations:~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
11088345|NCT01518192|BG002|Baseline|Controls|To obtain a control group from the same geographical area, each patient was asked if he/she had a family member or friend who was within 5 years of his/her age and had no history of Lyme disease (two of the potential control subjects were excluded due to this reason), and was not pregnant, lactating or immunocompromised.
11088346|NCT01518192|BG003|Baseline|Total|Total of all reporting groups
11088347|NCT01518192|FG000|Participant Flow|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
11088348|NCT01518192|FG001|Participant Flow|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
11088349|NCT01518192|FG002|Participant Flow|Controls|patients' family members or friends without a history of Lyme disease
11088350|NCT01518192|OG000|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
11088351|NCT01518192|OG001|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
11088352|NCT01518192|OG000|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 6 months post inclusion
11088353|NCT01518192|OG001|Outcome|Controls|controls with new or increased symptoms since enrollment at 6 months post inclusion
11088354|NCT01518192|OG001|Outcome|Cefuroximew Axetil|cefuroxime axetil 500 mg twice daily for 15 days
11088355|NCT01518192|OG000|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 12 months post inclusion
11088356|NCT01518192|OG001|Outcome|Controls|controls with new or increased symptoms since erythema migrans at 12 months post inclusion
11088357|NCT01518192|OG000|Outcome|Patients|patients with selected subjective symptoms at 12 months post inclusion
11088358|NCT01518192|OG001|Outcome|Controls|controls with selected subjective symptoms at 12 months post inclusion
11088359|NCT01518192|EG000|Reported Event|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
11088360|NCT01518192|EG001|Reported Event|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
11088361|NCT01518192|EG002|Reported Event|Controls|patients' family members or friends without a history of Lyme disease
11088362|NCT01518244|BG000|Baseline|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
11088363|NCT01518244|FG000|Participant Flow|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
11088364|NCT01518244|OG000|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
11088365|NCT01518244|EG000|Reported Event|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
11088366|NCT01518257|BG000|Baseline|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
11088367|NCT01518257|BG001|Baseline|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
11088368|NCT01518257|BG002|Baseline|Total|Total of all reporting groups
11088369|NCT01518257|FG000|Participant Flow|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
11088370|NCT01518257|FG001|Participant Flow|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
11088371|NCT01518257|OG000|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
11088372|NCT01518257|OG001|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
11088373|NCT01518257|EG000|Reported Event|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
11088374|NCT01518257|EG001|Reported Event|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
11088375|NCT01518270|BG000|Baseline|Healthy Females|Participant's eyelashes were photographed at one study visit.
11088376|NCT01518270|FG000|Participant Flow|Healthy Females|Participant's eyelashes were photographed at one study visit.
11088377|NCT01518270|OG000|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
11088378|NCT01518270|EG000|Reported Event|Healthy Females|Healthy Females
11088379|NCT01518309|BG000|Baseline|Pimavanserin|All patients started treatment with pimavanserin 20 mg/day. Based on clinical benefit and Investigator judgment, dose escalation to 40 mg and 60 mg was allowed, after a minimum of 2 and 4 weeks treatment duration, respectively. Dose reductions to 40 and/or 20 mg/day were allowed for the management of AEs or intolerability.
11088380|NCT01518309|FG000|Participant Flow|Pimavanserin|All patients started treatment with pimavanserin 20 mg/day. Based on clinical benefit and Investigator judgment, dose escalation to 40 mg and 60 mg was allowed, after a minimum of 2 and 4 weeks treatment duration, respectively. Dose reductions to 40 and/or 20 mg/day were allowed for the management of AEs or intolerability.
11088381|NCT01518309|OG000|Outcome|Pimavanserin|All patients started treatment with pimavanserin 20 mg/day. Based on clinical benefit and Investigator judgment, dose escalation to 40 mg and 60 mg was allowed, after a minimum of 2 and 4 weeks treatment duration, respectively. Dose reductions to 40 and/or 20 mg/day were allowed for the management of AEs or intolerability.
11088382|NCT01518309|EG000|Reported Event|Pimavanserin|All patients started treatment with pimavanserin 20 mg/day. Based on clinical benefit and Investigator judgment, dose escalation to 40 mg and 60 mg was allowed, after a minimum of 2 and 4 weeks treatment duration, respectively. Dose reductions to 40 and/or 20 mg/day were allowed for the management of AEs or intolerability.
11088383|NCT01518322|BG000|Baseline|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
11088384|NCT01518322|FG000|Participant Flow|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
11088385|NCT01518322|OG000|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
11088386|NCT01518322|OG001|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
11088387|NCT01518322|OG002|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
11088388|NCT01518322|OG001|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
11088389|NCT01518322|OG002|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high
11088390|NCT01518322|OG000|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
11088391|NCT01518322|EG000|Reported Event|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
11088392|NCT01518374|BG000|Baseline|Florbetapir-PET Scans|Florbetapir F 18: 370 MBq (10 mCi)
11088393|NCT01518374|FG000|Participant Flow|Florbetapir-PET Scans|Florbetapir F 18: 370 MBq (10 mCi)
11088394|NCT01518374|OG000|Outcome|Florbetapir-PET Scans|Florbetapir F 18: 370 MBq (10 mCi)
11088395|NCT01518374|EG000|Reported Event|Florbetapir-PET Scans|Florbetapir F 18: 370 MBq (10 mCi)
11088396|NCT01518530|BG000|Baseline|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
11088397|NCT01518530|FG000|Participant Flow|Chronic Neck Pain Patients Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
11088398|NCT01518530|OG000|Outcome|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
11088399|NCT01518530|EG000|Reported Event|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
11088400|NCT01518699|BG000|Baseline|Treatment Sequence ABC|"The subjects received sequence ABC in the three periods with a 4 day washout in between the periods. In each treatment period, subjects received a single dose of the treatment as follows:~In period 1 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.~In period 2 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.~in period 3 they received Moxifloxacin 400 mg tablet + HA 44 placebo."
11088401|NCT01518699|BG001|Baseline|Treatment Sequence ACB|"The subjects received sequence ACB in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.~In period 2 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.~in period 3 they received HA 44 placebo + Moxifloxacin placebo."
11088402|NCT01518699|BG002|Baseline|Treatment Sequence BAC|"The subjects received sequence BAC in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.~In period 2 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.~In period 3 they received Moxifloxacin 400 mg tablet + HA 44 placebo."
11088403|NCT01518699|BG003|Baseline|Treatment Sequence BCA|"The subjects received sequence BCA in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.~In period 2 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.~In period 3 they received HA 44 gel + Moxifloxacin placebo tablet."
11088404|NCT01518699|BG004|Baseline|Treatment Sequence CAB|"The subjects received sequence CAB in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.~In period 2 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.~In period 3 they received HA 44 placebo + Moxifloxacin placebo."
11088405|NCT01518699|BG005|Baseline|Treatment Sequence CBA|"The subjects received sequence CBA in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.~In period 2 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.~In period 3 they received HA 44 gel + Moxifloxacin placebo tablet."
11088406|NCT01518699|BG006|Baseline|Total|Total of all reporting groups
11088407|NCT01518699|FG000|Participant Flow|Treatment Sequence ABC|"The subjects received sequence ABC in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.~In period 2 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.~in period 3 they received Moxifloxacin 400 mg tablet + HA 44 placebo."
11088408|NCT01518699|FG001|Participant Flow|Treatment Sequence ACB|"The subjects received sequence ACB in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.~In period 2 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.~In period 3 they received HA 44 placebo + Moxifloxacin placebo."
11088409|NCT01518699|FG002|Participant Flow|Treatment Sequence BAC|"The subjects received sequence BAC in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.~In period 2 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.~In period 3 they received Moxifloxacin 400 mg tablet + HA 44 placebo."
11088410|NCT01518699|FG003|Participant Flow|Treatment Sequence BCA|"The subjects received sequence BCA in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.~In period 2 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.~In period 3 they received HA 44 gel + Moxifloxacin placebo tablet."
11088411|NCT01518699|FG004|Participant Flow|Treatment Sequence CAB|"The subjects received sequence CAB in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.~In period 2 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.~In period 3 they received HA 44 placebo + Moxifloxacin placebo."
11088412|NCT01518699|FG005|Participant Flow|Treatment Sequence CBA|"The subjects received sequence CBA in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:~In period 1 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.~In period 2 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.~In period 3 they received HA 44 gel + Moxifloxacin placebo tablet."
11088413|NCT01518699|OG000|Outcome|HA 44 Gel + Moxifloxacin Placebo|The maximal difference between baseline and post treatment value in QTcF
11088414|NCT01518699|OG001|Outcome|HA 44 Placebo + Moxifloxacin Placebo|The maximal difference between baseline and post treatment value in QTcF
11088415|NCT01518699|OG002|Outcome|Moxifloxacin 400 mg Tablet +HA 44 Placebo|The maximum difference between baseline and post treatment values in QTcF
11088416|NCT01518699|EG000|Reported Event|HA44 Abametapir Lotion|Study drug plus positive-control placebo.
11088417|NCT01518699|EG001|Reported Event|Placebo|Placebo plus positive-control placebo.
11088418|NCT01518699|EG002|Reported Event|Moxifloxacin|Placebo plus Moxifloxacin
11088419|NCT01518868|BG000|Baseline|Overall|Participants received both treatment groups in this cross-over study.
11088420|NCT01518868|FG000|Participant Flow|Investigational Contact Lens Then PureVision Contact Lens|"multifocal high add soft contact lens~Investigational contact lens: Worn on a daily wear basis for one week.~Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week"
11088421|NCT01518868|FG001|Participant Flow|PureVision Contact Lens|"Multi-focal contact lens then Investigational Contact Lens~PureVision contact lens: Worn on a daily wear basis for one week~multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week."
11088422|NCT01518868|OG000|Outcome|Investigational Contact Lens|"multifocal high add soft contact lens~Investigational contact lens: Worn on a daily wear basis for one week."
11088423|NCT01518868|OG001|Outcome|PureVision Contact Lens|"Multi-focal contact lens~PureVision contact lens: Worn on a daily wear basis for one week"
11150583|NCT01877941|FG000|Participant Flow|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
11150584|NCT01877941|OG000|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.~Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
11150585|NCT01877941|OG000|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
11150586|NCT01877941|EG000|Reported Event|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored during surgery and during post-surgical recovery. For instance, patients with ischemic heart disease undergoing cardiac bypass graft or percutaneous coronary intervention.~No adverse events."
11150587|NCT01878006|BG000|Baseline|All Study Participants|All participants who started the study.
11150588|NCT01878006|FG000|Participant Flow|First Morphine, Then Placebo|All participants received in counterbalanced order an IV infusion of morphine (10 mg/70 kg) or an equivalent volume of normal saline over 20-30 s
11150589|NCT01878006|FG001|Participant Flow|First Placebo, Then Morphine|All participants received in counterbalanced order an IV infusion of morphine (10 mg/70 kg) or an equivalent volume of normal saline over 20-30 s
11150590|NCT01878006|OG000|Outcome|Morphine|All participants received in counterbalanced order an IV infusion of morphine (10 mg/70 kg) or an equivalent volume of normal saline (placebo) over 20-30 s
11150591|NCT01878006|OG001|Outcome|Placebo|All participants received in counterbalanced order an IV infusion of morphine (10 mg/70 kg) or an equivalent volume of normal saline (placebo) over 20-30 s
11150592|NCT01878006|EG000|Reported Event|Morphine|All participants received in counterbalanced order an IV infusion of morphine (10 mg/70 kg) or an equivalent volume of normal saline over 20-30 s
11150593|NCT01878006|EG001|Reported Event|Placebo|All participants received in counterbalanced order an IV infusion of morphine (10 mg/70 kg) or an equivalent volume of normal saline over 20-30 s
11150594|NCT01878084|BG000|Baseline|All Study Participants|"Bone regeneration utilizing tissue engineering principles and approach via using porous bioactive glass prepared by sol gel technique to properly fill the empty socket after tooth extraction. The target is to preserve the buccal and lingual alveolar plates of the socket regarding width and height, to avoid bone resorption and to stimulate bone regeneration. This novel technique will be evaluated via histological (biopsy), radiographic, and bone density measurements in addition to clinical assessment.~This study represents a split-mouth study where the right or left/ upper or lower premolar could be assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)~The extraction sockets will be allocated either to the control : Extraction socket will be left empty~or~Test: Extraction socket will be augmented using bioactive glass (sol-gel)"
11150595|NCT01878084|FG000|Participant Flow|All Study Participants|"Bone regeneration utilizing tissue engineering principles and approach via using porous bioactive glass prepared by sol gel technique to properly fill the empty socket after tooth extraction. The target is to preserve the buccal and lingual alveolar plates of the socket regarding width and height, to avoid bone resorption and to stimulate bone regeneration. This novel technique will be evaluated via histological (biopsy), radiographic, and bone density measurements in addition to clinical assessment.~This study represents a split-mouth study where the right or left/ upper or lower premolar could be assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)~The extraction sockets will be allocated either to the control : Extraction socket will be left empty~or~Test: Extraction socket will be augmented using bioactive glass (sol-gel)"
11150596|NCT01878084|OG000|Outcome|All Study Participants|"This study represented a split-mouth study where the right or left/ upper or lower premolar was assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)~The extraction sockets were allocated either to the control : Extraction socket were left empty~or~Test: Extraction socket were augmented using bioactive glass (sol-gel~bioactive glass (sol-gel): Extraction sockets were augmented using bioactive glass (sol-gel)"
11150597|NCT01878084|OG000|Outcome|All Study Participants|"This study represented a split-mouth study where the right or left/ upper or lower premolar were assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)~The extraction sockets were allocated either to the control : Extraction socket were left empty~or~Test: Extraction socket were augmented using bioactive glass (sol-gel"
11088424|NCT01518868|EG000|Reported Event|Investigational Contact Lens|"multifocal high add soft contact lens~Investigational contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week.~Investigational contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week.~Investigational contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one week"
11088425|NCT01518868|EG001|Reported Event|PureVision Contact Lens|"Multi-focal contact lens~PureVision contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week~PureVision contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week.~PureVision contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one week"
11088426|NCT01518946|BG000|Baseline|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
11088427|NCT01518946|BG001|Baseline|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
11088428|NCT01518946|BG002|Baseline|Total|Total of all reporting groups
11088429|NCT01518946|FG000|Participant Flow|Midodrine HCl (Open-label Phase)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld.
11088430|NCT01518946|FG001|Participant Flow|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
11088431|NCT01518946|FG002|Participant Flow|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
11088432|NCT01518946|OG000|Outcome|Placebo|single dose of matching placebo
11088433|NCT01518946|OG001|Outcome|Midodrine HCl|dose at the subject's current dose level
11088434|NCT01518946|EG000|Reported Event|Midodrine HCl (Open-label Phase)|dose at the subject's current dose level
11088435|NCT01518946|EG001|Reported Event|Placebo (Randomized Phase)|single dose of matching placebo
11088436|NCT01518946|EG002|Reported Event|Midodrine HCl (Randomized Phase)|dose at the subject's current dose level
11088437|NCT01518972|BG000|Baseline|Prazosin|"Prazosin medication~Prazosin: Form: Prazosin will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
11088438|NCT01518972|BG001|Baseline|Placebo|"Placebo medication~Placebo medication: Form: Placebo will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
11088439|NCT01518972|BG002|Baseline|Total|Total of all reporting groups
11088440|NCT01518972|FG000|Participant Flow|Prazosin|"Prazosin medication~Prazosin: Form: Prazosin will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
11088441|NCT01518972|FG001|Participant Flow|Placebo|"Placebo medication~Placebo medication: Form: Placebo will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
11088442|NCT01518972|OG000|Outcome|Prazosin|"Prazosin medication~Prazosin: Form: Prazosin will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
11088443|NCT01518972|OG001|Outcome|Placebo|"Placebo medication~Placebo medication: Form: Placebo will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
11088444|NCT01518972|EG000|Reported Event|Placebo|"Placebo medication~Placebo medication: Form: Placebo will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
11088445|NCT01518972|EG001|Reported Event|Prazosin|"Prazosin medication~Prazosin: Form: Prazosin will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
11088446|NCT01519063|BG000|Baseline|Naltrexone and Memantine First|Patients in this arm received Naltrexone and Memantine first.
11088447|NCT01519063|BG001|Baseline|Naltrexone and Placebo First|Patients in this arm received Naltrexone and Placebo first.
11088448|NCT01519063|BG002|Baseline|Total|Total of all reporting groups
11088449|NCT01519063|FG000|Participant Flow|Naltrexone and Memantine First|Patients received Naltrexone and Memantine first in this arm.
11088450|NCT01519063|FG001|Participant Flow|Naltrexone and Placebo First|Patients received Naltrexone and Placebo first in this arm.
11088451|NCT01519063|OG000|Outcome|Naltrexone and Memantine|"Treatment with Naltrexone and memantine~Naltrexone and memantine: Naltrexone 50mg memantine 20mg"
11088452|NCT01519063|OG001|Outcome|Naltrexone and Placebo|"Treatment with naltrexone and placebo~Naltrexone and Placebo: Naltrexone 50 mg Placebo"
11088453|NCT01519063|EG000|Reported Event|Naltrexone and Memantine|"Treatment with Naltrexone and memantine~Naltrexone and memantine: Naltrexone 50mg memantine 20mg"
11088454|NCT01519063|EG001|Reported Event|Naltrexone and Placebo|"Treatment with naltrexone and placebo~Naltrexone and Placebo: Naltrexone 50 mg Placebo"
11088455|NCT01519089|BG000|Baseline|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
11150598|NCT01878084|EG000|Reported Event|All Study Participants|"This study represented a split-mouth study where the right or left/ upper or lower premolar were assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)~The extraction sockets were allocated either to the control : Extraction socket were left empty~or~Test: Extraction socket were augmented using bioactive glass (sol-gel)"
11150599|NCT01878097|BG000|Baseline|Green Dot Bystander Training|"26 high schools: 13 receiving Green Dot intervention and 13 no intervention~Green Dot Bystander Intevention: Intervention allocated at the school level"
11150600|NCT01878097|BG001|Baseline|Control Training|
11150601|NCT01878097|BG002|Baseline|Total|Total of all reporting groups
11150602|NCT01878097|FG000|Participant Flow|Green Dot Bystander Training|"13 receiving Green Dot intervention~Green Dot Bystander Intevention: Intervention allocated at the school level"
11150603|NCT01878097|FG001|Participant Flow|Control|13 high school receiving no bystander training (no intervention)
11150604|NCT01878097|OG000|Outcome|Green Dot Bystander Training|Phase one and two.
11150605|NCT01878097|OG001|Outcome|Control|No bystander intervention
11150606|NCT01878097|EG000|Reported Event|GreenDot|"Experimental: GreenDot Bystander Training GreenDot is a bystander intervention program that empowers students to actively question peer support for sexual violence (SV) and become change agents who play a significant role in preventing sexual violence."
11150607|NCT01878097|EG001|Reported Event|Control|In 13 Kentucky region , 2 demographically comparable high schools were recruited to participate in GreenDot intervention as either the intervention or control site. Schools were randomly assigned to the intervention. Control schools received no additional programming on their campus.
11150608|NCT01878149|BG000|Baseline|VEO® Lateral Access and Interbody Fusion System|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the VEO® spinal procedure. VEO® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
11150609|NCT01878149|BG001|Baseline|eXtreme Lumbar Interbody Fusion (XLIF®)|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the XLIF® spinal procedure. XLIF® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
11150610|NCT01878149|BG002|Baseline|Total|Total of all reporting groups
11150611|NCT01878149|FG000|Participant Flow|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the Baxano Surgical LLIF system, which employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. The VEO® system was developed with an initial, radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. Dissection through the psoas is then performed with direct vision in conjunction with EMG. The psoas muscle is split anterior-posterior along muscle fiber lines and the retraction is performed with two independent blades. Insertion depth may be varied to avoid muscle creep, and the toed-out blade tips are positioned under the psoas to hold the system in place. An inner sleeve is inserted to lock the blades in place at the desired radial tension for a customizable disc space exposure. Standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
11150612|NCT01878149|FG001|Participant Flow|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc.When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
11150613|NCT01878149|OG000|Outcome|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
11150614|NCT01878149|OG001|Outcome|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
11150615|NCT01878149|EG000|Reported Event|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO® Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
11088456|NCT01519089|BG001|Baseline|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
11088457|NCT01519089|BG002|Baseline|Total|Total of all reporting groups
11088458|NCT01519089|FG000|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
11088459|NCT01519089|FG001|Participant Flow|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
11088460|NCT01519089|OG000|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
11088461|NCT01519089|OG001|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
11088462|NCT01519089|OG002|Outcome|Total|(=sum across Arm/Groups)
11088463|NCT01519089|EG000|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
11088464|NCT01519089|EG001|Reported Event|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
11088465|NCT01519089|EG002|Reported Event|Total|(=sum across Arm/Groups)
11088466|NCT01519167|BG000|Baseline|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
11088467|NCT01519167|BG001|Baseline|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
11088468|NCT01519167|BG002|Baseline|Total|Total of all reporting groups
11088469|NCT01519167|FG000|Participant Flow|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
11088470|NCT01519167|FG001|Participant Flow|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
11088471|NCT01519167|OG000|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
11088472|NCT01519167|OG001|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
11088473|NCT01519167|EG000|Reported Event|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
11088474|NCT01519167|EG001|Reported Event|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
11088475|NCT01519206|BG000|Baseline|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088476|NCT01519206|FG000|Participant Flow|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088477|NCT01519206|OG000|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088478|NCT01519206|OG000|Outcome|Treated Subjects GAIS Data - 60 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088479|NCT01519206|OG001|Outcome|Treated Subjects GAIS Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088480|NCT01519206|OG002|Outcome|Treated Subjects GAIS Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088481|NCT01519206|OG003|Outcome|Treated Subjects GAIS Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088482|NCT01519206|OG000|Outcome|Treated Subjects PSQ Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088483|NCT01519206|OG001|Outcome|Treated Subjects PSQ Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088484|NCT01519206|OG002|Outcome|Treated Subjects PSQ Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088485|NCT01519206|EG000|Reported Event|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
11088486|NCT01519245|BG000|Baseline|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
11088487|NCT01519245|BG001|Baseline|Placebo|Normal saline (70mL)
11088488|NCT01519245|BG002|Baseline|Total|Total of all reporting groups
11088489|NCT01519245|FG000|Participant Flow|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
11088490|NCT01519245|FG001|Participant Flow|Placebo|Normal saline (70mL)
11088491|NCT01519245|OG000|Outcome|Trial Drug|"Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)~Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)"
11088492|NCT01519245|OG001|Outcome|Placebo|"Normal saline (70mL)~Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)"
11088493|NCT01519245|OG000|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
11088494|NCT01519245|OG001|Outcome|Placebo|Normal saline (70mL)
11088495|NCT01519245|EG000|Reported Event|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
11088496|NCT01519245|EG001|Reported Event|Placebo|Normal saline (70mL)
11173758|NCT02017327|OG002|Outcome|Lumigan 0.03% Unit Dose|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Lumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers."
11150616|NCT01878149|EG001|Reported Event|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
11150617|NCT01878175|BG000|Baseline|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
11150618|NCT01878175|FG000|Participant Flow|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at VA medical center, in-home with clinical personnel, and via telephone. Intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program focuses on lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week.
11150619|NCT01878175|OG000|Outcome|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
11150620|NCT01878175|OG000|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
11150621|NCT01878175|EG000|Reported Event|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
11150622|NCT01878214|BG000|Baseline|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
11150623|NCT01878214|BG001|Baseline|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
11150624|NCT01878214|BG002|Baseline|Total|Total of all reporting groups
11150625|NCT01878214|FG000|Participant Flow|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
11150626|NCT01878214|FG001|Participant Flow|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
11150627|NCT01878214|OG000|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
11150628|NCT01878214|OG001|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
11150629|NCT01878214|EG000|Reported Event|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
11150630|NCT01878214|EG001|Reported Event|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
11150631|NCT01878253|BG000|Baseline|Sidus Stem-Free Shoulder System|"This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.~Sidus Stem-Free Total Shoulder Arthroplasty System"
11150632|NCT01878253|FG000|Participant Flow|Sidus Stem-Free Shoulder System|"This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.~Sidus Stem-Free Total Shoulder Arthroplasty System"
11150633|NCT01878253|OG000|Outcome|Sidus Stem-Free Shoulder System|"This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.~Sidus Stem-Free Total Shoulder Arthroplasty System. ASES Functional and Pain Summary scores"
11150634|NCT01878253|OG000|Outcome|Sidus Stem-Free Shoulder System|"Absence of radiographic evidence of pending failure of the humeral components, assessed at 2 years which may include the following:~implant fracture~progressive implant migration or subsidence ≥ 5 mm"
11150635|NCT01878253|OG000|Outcome|Investigational|Frequency of device related serious adverse events
11150636|NCT01878253|OG000|Outcome|Sidus Stem-Free Shoulder System|"This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.~Sidus Stem-Free Total Shoulder Arthroplasty System"
11088497|NCT01519271|BG000|Baseline|Placebo Patch First Then 5-10cm2 Rivastigmine Patch|"Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Each phase lasted 10 weeks."
11088498|NCT01519271|BG001|Baseline|5-10cm2 Rivastigmine Patch First First Then Placebo Patch|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).~Each phase lasted 10 weeks."
11088499|NCT01519271|BG002|Baseline|Total|Total of all reporting groups
11088500|NCT01519271|FG000|Participant Flow|Placebo First Then Rivastigmine|"Placebo patches placed on skin daily in Phase 1 and Rivastigmine 5-10cm2 patches in Phase 2. Each phase lasted for 10 weeks.~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."
11088501|NCT01519271|FG001|Participant Flow|Rivastigmine First Then Placebo|"5-10cm2 rivastigmine patch daily first in phase 1 and placebo patch daily in phase 2. Each phase lasted for 10 weeks.~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."
11088502|NCT01519271|OG000|Outcome|Placebo Patch|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
11088503|NCT01519271|OG001|Outcome|Exelon Patch (Rivastigmine Transdermal System)|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
11088504|NCT01519271|OG000|Outcome|Placebo|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
11088505|NCT01519271|OG001|Outcome|Rivastigmine|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
11088506|NCT01519271|EG000|Reported Event|Placebo Patch|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
11088507|NCT01519271|EG001|Reported Event|Exelon Patch (Rivastigmine Transdermal System)|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
11088508|NCT01519284|BG000|Baseline|Group 1|"Placebo at all the dosing times~Placebo: placebo (four times a day)"
11088509|NCT01519284|BG001|Baseline|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose~BIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
11088510|NCT01519284|BG002|Baseline|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)~BIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg"
11088511|NCT01519284|BG003|Baseline|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)~BIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg"
11088512|NCT01519284|BG004|Baseline|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose~Entacapone: Entacapone 200 mg~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
11088513|NCT01519284|BG005|Baseline|Total|Total of all reporting groups
11088514|NCT01519284|FG000|Participant Flow|Group 1|Placebo at all the dosing times
11088515|NCT01519284|FG001|Participant Flow|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
11088516|NCT01519284|FG002|Participant Flow|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
11088517|NCT01519284|FG003|Participant Flow|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
11088518|NCT01519284|FG004|Participant Flow|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
11088519|NCT01519284|OG000|Outcome|Group 1|Placebo at all the dosing times
11088520|NCT01519284|OG001|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
11088521|NCT01519284|OG002|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
11088522|NCT01519284|OG003|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
11088523|NCT01519284|OG004|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
11088524|NCT01519284|EG000|Reported Event|Group 1|Placebo at all the dosing times
11088525|NCT01519284|EG001|Reported Event|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
11088526|NCT01519284|EG002|Reported Event|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
11088527|NCT01519284|EG003|Reported Event|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
11088528|NCT01519284|EG004|Reported Event|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
11088529|NCT01519323|BG000|Baseline|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
11088530|NCT01519323|FG000|Participant Flow|Vemurafenib Dose Escalation Cohort Level 1|Participants received 720 milligram (mg) of vemurafenib by mouth twice daily (BID).
11088531|NCT01519323|FG001|Participant Flow|Vemurafenib Dose Escalation Cohort Level 2|Participants received 960 mg of vemurafenib by mouth BID.
11088532|NCT01519323|OG000|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
11088533|NCT01519323|OG000|Outcome|Vemurafenib 720 mg|Participants enrolled in the first cohort received vemurafenib 720 mg by mouth BID.
11088534|NCT01519323|OG001|Outcome|Vemurafenib 960 mg|Participants enrolled in the second cohort received vemurafenib 960 mg by mouth BID.
11088535|NCT01519323|EG000|Reported Event|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
11088536|NCT01519414|BG000|Baseline|Arm I (Tivantinib)|Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11088537|NCT01519414|BG001|Baseline|Arm II (Placebo)|Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
11088538|NCT01519414|BG002|Baseline|Total|Total of all reporting groups
11088539|NCT01519414|FG000|Participant Flow|Arm I (Tivantinib)|Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11088540|NCT01519414|FG001|Participant Flow|Arm II (Placebo)|Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
11088541|NCT01519414|FG002|Participant Flow|Crossover From Placebo to Tivantinib|Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
11088542|NCT01519414|OG000|Outcome|Arm I (Tivantinib)|Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11088543|NCT01519414|OG001|Outcome|Arm II (Placebo)|Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
11088544|NCT01519414|OG000|Outcome|Arm I (Tivantinib)|Arm I: Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11088545|NCT01519414|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to
11088546|NCT01519414|OG002|Outcome|Crossover From Placebo to Tivantinib|Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
11088547|NCT01519414|OG001|Outcome|Arm II (Placebo)|Arm II: Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
11088548|NCT01519414|EG000|Reported Event|Arm I (Tivantinib)|Patients receive tivantinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11088549|NCT01519414|EG001|Reported Event|Arm II (Placebo)|Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
11088550|NCT01519414|EG002|Reported Event|Crossover From Placebo to Tivantinib|Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.
11088551|NCT01519427|BG000|Baseline|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
11088552|NCT01519427|FG000|Participant Flow|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
11088553|NCT01519427|OG000|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
11088554|NCT01519427|EG000|Reported Event|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
11088555|NCT01519453|BG000|Baseline|Home Based Asthma Education|"This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.~For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver."
11088556|NCT01519453|BG001|Baseline|Control|"This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.~Caregiver is not provided a control arm specific intervention."
11088557|NCT01519453|BG002|Baseline|Total|Total of all reporting groups
11088558|NCT01519453|FG000|Participant Flow|Home Based Asthma Education Arm|"This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.~For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver."
11088559|NCT01519453|FG001|Participant Flow|Control Arm|"This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.~Caregiver is not provided a control arm specific intervention."
11088560|NCT01519453|OG000|Outcome|Home Based Asthma Education|"This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.~For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver."
11088561|NCT01519453|OG001|Outcome|Control|"This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.~Caregiver is not provided a control arm specific intervention."
11088562|NCT01519453|EG000|Reported Event|Home Based Asthma Education|"This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.~For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver."
11088563|NCT01519453|EG001|Reported Event|Control|"This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.~Caregiver is not provided a control arm specific intervention."
11088564|NCT01519466|BG000|Baseline|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
11088565|NCT01519466|BG001|Baseline|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
11088566|NCT01519466|BG002|Baseline|Total|Total of all reporting groups
11088567|NCT01519466|FG000|Participant Flow|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
11088568|NCT01519466|FG001|Participant Flow|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
11088569|NCT01519466|OG000|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
11088570|NCT01519466|OG001|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
11088571|NCT01519466|EG000|Reported Event|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
11088572|NCT01519466|EG001|Reported Event|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
11088573|NCT01519518|BG000|Baseline|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
11088574|NCT01519518|BG001|Baseline|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
11088575|NCT01519518|BG002|Baseline|Total|Total of all reporting groups
11088576|NCT01519518|FG000|Participant Flow|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
11088577|NCT01519518|FG001|Participant Flow|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
11088578|NCT01519518|OG000|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
11088579|NCT01519518|OG001|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
11088580|NCT01519518|EG000|Reported Event|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
11088581|NCT01519518|EG001|Reported Event|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
11088582|NCT01519570|BG000|Baseline|An Informational Packet Regarding Shingles and the HZV|An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
11088583|NCT01519570|BG001|Baseline|Standard Medical Care From Their Primary Care Physician|
11088584|NCT01519570|BG002|Baseline|Total|Total of all reporting groups
11088585|NCT01519570|FG000|Participant Flow|An Informational Packet Regarding Shingles and the HZV|An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
11088586|NCT01519570|FG001|Participant Flow|Standard Medical Care From Their Primary Care Physician|
11088587|NCT01519570|OG000|Outcome|An Informational Packet Regarding Shingles and the HZV|An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
11088588|NCT01519570|OG001|Outcome|Standard Medical Care From Their Primary Care Physician|
11088589|NCT01519570|EG000|Reported Event|An Informational Packet Regarding Shingles and the HZV|An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
11088590|NCT01519570|EG001|Reported Event|Standard Medical Care From Their Primary Care Physician|
11088591|NCT01519635|BG000|Baseline|Aliskiren|Patients with essential hypertension stage 1 and 2 .
11088592|NCT01519635|BG001|Baseline|HCTZ|Patients with essential hypertension stage 1 and 2
11088593|NCT01519635|BG002|Baseline|Total|Total of all reporting groups
11088594|NCT01519635|FG000|Participant Flow|Aliskiren|"Aliskiren: Drug therapy will be started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.~11 patients were enrolled and completed the study"
11088595|NCT01519635|FG001|Participant Flow|Hydrochlorothiazide|"Hydrochlorothiazide: Drug therapy will be started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.~Finally 9 patients were enrolled and completed the study"
11088596|NCT01519635|OG000|Outcome|Aliskiren|Aliskiren: Drug therapy will be started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
11088597|NCT01519635|OG001|Outcome|Hydrochlorothiazide|Hydrochlorothiazide: Drug therapy will be started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
11150637|NCT01878253|OG000|Outcome|Sidus Stem-Free Shoulder System|"This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.~Sidus Stem-Free Total Shoulder Arthroplasty System. ASES Functional Summary scores"
11150638|NCT01878253|OG000|Outcome|Sidus Stem-Free Shoulder System|"This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.~Sidus Stem-Free Total Shoulder Arthroplasty System SF-12 Mental Health and Physical Composite Scores"
11150639|NCT01878253|EG000|Reported Event|Sidus Stem-Free Shoulder System|"This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.~Sidus Stem-Free Total Shoulder Arthroplasty System"
11150640|NCT01878292|BG000|Baseline|Placebo|Dose-matched placebo tablets, once per day, oral administration
11150641|NCT01878292|BG001|Baseline|Vilazodone 15 mg|15 mg vilazodone tablets, once per day, oral administration
11150642|NCT01878292|BG002|Baseline|Vilazodone 30 mg|30 mg vilazodone tablets, once per day, oral administration
11150643|NCT01878292|BG003|Baseline|Total|Total of all reporting groups
11150644|NCT01878292|FG000|Participant Flow|Placebo|Dose-matched placebo tablets, once per day, oral administration
11150645|NCT01878292|FG001|Participant Flow|Vilazodone 15 mg|15 mg vilazodone tablets, once per day, oral administration
11150646|NCT01878292|FG002|Participant Flow|Vilazodone 30 mg|30 mg vilazodone tablets, once per day, oral administration
11150647|NCT01878292|OG000|Outcome|Placebo|Dose-matched placebo tablets, once per day, oral administration
11150648|NCT01878292|OG001|Outcome|Vilazodone 15 mg|15 mg vilazodone tablets, once per day, oral administration
11150649|NCT01878292|OG002|Outcome|Vilazodone 30 mg|30 mg vilazodone tablets, once per day, oral administration
11150650|NCT01878292|EG000|Reported Event|Placebo|Dose-matched placebo tablets, once per day, oral administration
11150651|NCT01878292|EG001|Reported Event|Vilazodone 15 mg|15 mg vilazodone tablets, once per day, oral administration
11150652|NCT01878292|EG002|Reported Event|Vilazodone 30 mg|30 mg vilazodone tablets, once per day, oral administration
11150653|NCT01878383|BG000|Baseline|Non-pregnant Women/Active HSV Lesions|"Women presenting to local health department~Genexpert assay"
11150654|NCT01878383|BG001|Baseline|Pregnant Women/no Active HSV Lesions|"Women presenting in active labor~Genexpert assay"
11150655|NCT01878383|BG002|Baseline|Total|Total of all reporting groups
11150656|NCT01878383|FG000|Participant Flow|Non-pregnant Women/Active HSV Lesions|"Women presenting to local health department~Genexpert assay"
11150657|NCT01878383|FG001|Participant Flow|Pregnant Women/no Active HSV Lesions|Women presenting in active labor will be tested for HSV utilizing the Genexpert assay
11150658|NCT01878383|OG000|Outcome|Non-pregnant Women/Active HSV Lesions|"Women presenting to local health department~Genexpert assay"
11150659|NCT01878383|OG000|Outcome|Pregnant Women/no Active HSV Lesions|"Women presenting in active labor~Genexpert assay"
11150660|NCT01878383|EG000|Reported Event|Non-pregnant Women/Active HSV Lesions|"Women presenting to local health department~Genexpert assay"
11150661|NCT01878383|EG001|Reported Event|Pregnant Women/no Active HSV Lesions|"Women presenting in active labor~Genexpert assay"
11150662|NCT01878526|BG000|Baseline|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
11150663|NCT01878526|BG001|Baseline|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
11150664|NCT01878526|BG002|Baseline|Total|Total of all reporting groups
11150665|NCT01878526|FG000|Participant Flow|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
11150666|NCT01878526|FG001|Participant Flow|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
11150667|NCT01878526|OG000|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
11150668|NCT01878526|OG001|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
11150669|NCT01878526|OG000|Outcome|Overall Systemic Sclerosis With GERD (Before Randomization)|omeprazole 20 mg bid ac for 4 weeks for overall systemic sclerosis with GERD
11150670|NCT01878526|EG000|Reported Event|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
11150671|NCT01878526|EG001|Reported Event|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
11150672|NCT01878604|BG000|Baseline|Patients of HoFH|patients of Homozygous Familial Hypercholesterolemia
11150673|NCT01878604|FG000|Participant Flow|Homozygous Familial Hypercholesterolemia|"Gene Analysis for Homozygous Familial Hypercholesterolemia cases~Gene analysis: Gene analysis"
11150674|NCT01878604|OG000|Outcome|HoFH Patients|HoFH patients
11150675|NCT01878604|OG000|Outcome|HoFH Patients|"patients of Homozygous Familial Hypercholesterolemia that meet the Inclusion criteria:~Cutaneous xanthomata before the age of ten years~LDLC > 13 mmol/L before treatment or > 7.76 mmol/L despite treatment~Phenotypic features in keeping with HeFH in both parents"
11150676|NCT01878604|EG000|Reported Event|HoFH Patients|all HoFH patients enrolled in this study
11150677|NCT01878656|BG000|Baseline|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
11150678|NCT01878656|BG001|Baseline|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
11150679|NCT01878656|BG002|Baseline|Total|Total of all reporting groups
11150680|NCT01878656|FG000|Participant Flow|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
11150681|NCT01878656|FG001|Participant Flow|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
11150682|NCT01878656|OG000|Outcome|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
11150683|NCT01878656|OG001|Outcome|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
11150684|NCT01878656|EG000|Reported Event|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
11150685|NCT01878656|EG001|Reported Event|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
11150686|NCT01878799|BG000|Baseline|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
11150687|NCT01878799|BG001|Baseline|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
11150688|NCT01878799|BG002|Baseline|Total|Total of all reporting groups
11150689|NCT01878799|FG000|Participant Flow|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
11150690|NCT01878799|FG001|Participant Flow|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
11150691|NCT01878799|OG000|Outcome|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
11150692|NCT01878799|OG001|Outcome|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
11150693|NCT01878799|EG000|Reported Event|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
11150694|NCT01878799|EG001|Reported Event|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
11150695|NCT01878812|BG000|Baseline|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
11150696|NCT01878812|BG001|Baseline|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
11150697|NCT01878812|BG002|Baseline|Total|Total of all reporting groups
11150698|NCT01878812|FG000|Participant Flow|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
11150699|NCT01878812|FG001|Participant Flow|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
11150700|NCT01878812|OG000|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
11150701|NCT01878812|OG001|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
11150702|NCT01878812|EG000|Reported Event|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
11150703|NCT01878812|EG001|Reported Event|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
11150704|NCT01878825|BG000|Baseline|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11150705|NCT01878825|BG001|Baseline|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11150706|NCT01878825|BG002|Baseline|Total|Total of all reporting groups
11150707|NCT01878825|FG000|Participant Flow|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11150708|NCT01878825|FG001|Participant Flow|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11150709|NCT01878825|OG000|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11150710|NCT01878825|OG001|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11150711|NCT01878825|OG000|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11150712|NCT01878825|OG001|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11150713|NCT01878825|OG002|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11150714|NCT01878825|OG003|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11150715|NCT01878825|OG002|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11150716|NCT01878825|OG003|Outcome|Fluviral >60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11150717|NCT01878825|OG000|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11150718|NCT01878825|OG000|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11150719|NCT01878825|OG001|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11150720|NCT01878825|EG000|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11150721|NCT01878825|EG001|Reported Event|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
11150722|NCT01878890|BG000|Baseline|Efavirenz: 600 mg|"Cohort 1 : Participants received 600 mg of Efavirenz (oral / once a day), until progression or toxicity.~Efavirenz 600mg: Efavirenz 600 mg (oral daily intake)"
11150723|NCT01878890|BG001|Baseline|Efavirenz: 1200 mg|"Cohort 2 : Participants received 1200 mg of Efavirenz (oral / once a day), until progression or toxicity.~Efavirenz 600mg: Efavirenz 1200 mg (oral daily intake)"
11150724|NCT01878890|BG002|Baseline|Efavirenz: 1800 mg|"Cohort 3 : Participants received 1800 mg of Efavirenz (oral / once a day), until progression or toxicity.~Efavirenz 600mg: Efavirenz 1800 mg (oral daily intake)"
11150725|NCT01878890|BG003|Baseline|Efavirenz: 2200 mg|"Cohort 4 : Participants received 2200 mg of Efavirenz (oral / once a day), until progression or toxicity.~Efavirenz 600mg: Efavirenz 2200 mg (oral daily intake)"
11150726|NCT01878890|BG004|Baseline|Total|Total of all reporting groups
11150727|NCT01878890|FG000|Participant Flow|Efavirenz - 600 mg|Participants received 600 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150728|NCT01878890|FG001|Participant Flow|Efavirenz - 1200 mg|Participants received 1200 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150729|NCT01878890|FG002|Participant Flow|Efavirenz - 1800 mg|Participants received 1800 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150730|NCT01878890|FG003|Participant Flow|Efavirenz - 2200 mg|Participants received 2200 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150731|NCT01878890|OG000|Outcome|All Participants|All participants who received at least 1 dose of Efavirenz, either at 600 mg, 1200 mg, 1800 mg, or 2200 mg.
11150732|NCT01878890|OG000|Outcome|Efavirenz: 600 mg|Cohort 1 : Participants received 600 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150733|NCT01878890|OG001|Outcome|Efavirenz: 1200 mg|Cohort 2 : Participants received 1200 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150734|NCT01878890|OG002|Outcome|Efavirenz: 1800 mg|Cohort 3 : Participants received 1800 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150735|NCT01878890|OG003|Outcome|Efavirenz: 2200 mg|Cohort 4 : Participants received 2200 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150736|NCT01878890|EG000|Reported Event|Efavirenz: 600 mg|Cohort 1 : Participants received 600 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150737|NCT01878890|EG001|Reported Event|Efavirenz: 1200 mg|Cohort 2 : Participants received 1200 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150738|NCT01878890|EG002|Reported Event|Efavirenz: 1800 mg|Cohort 3 : Participants received 1800 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150739|NCT01878890|EG003|Reported Event|Efavirenz: 2200 mg|Cohort 4 : Participants received 2200 mg of Efavirenz (oral / once a day), until progression or toxicity.
11150740|NCT01879059|BG000|Baseline|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
11150741|NCT01879059|FG000|Participant Flow|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
11150742|NCT01879059|OG000|Outcome|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
11150743|NCT01879059|EG000|Reported Event|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
11150744|NCT01879072|BG000|Baseline|Allogeneic Hematopoietic Stem Cell Transplant|Participants received allogeneic hematopoietic stem cell transplantation
11150745|NCT01879072|FG000|Participant Flow|Allogeneic Hematopoietic Stem Cell Transplant|Participants received allogeneic hematopoietic stem cell transplantation
11150746|NCT01879072|OG000|Outcome|Allogeneic Hematopoietic Stem Cell Transplant|Participants received allogeneic hematopoietic stem cell transplantation
11150747|NCT01879072|EG000|Reported Event|Hematopoietic Stem Cell Transplant|
11150748|NCT01879176|BG000|Baseline|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1.
11150749|NCT01879176|BG001|Baseline|Control|No filter will be installed on the CPB machine.
11150750|NCT01879176|BG002|Baseline|Total|Total of all reporting groups
11150751|NCT01879176|FG000|Participant Flow|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .~CytoSorb"
11150752|NCT01879176|FG001|Participant Flow|Control|No filter will be installed on the CPB machine.
11150753|NCT01879176|OG000|Outcome|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
11150754|NCT01879176|OG001|Outcome|Control|No filter will be installed on the CPB machine.
11150755|NCT01879176|EG000|Reported Event|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .~CytoSorb"
11150756|NCT01879176|EG001|Reported Event|Control|No filter will be installed on the CPB machine.
11150757|NCT01879319|BG000|Baseline|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
11150758|NCT01879319|BG001|Baseline|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
11150759|NCT01879319|BG002|Baseline|Total|Total of all reporting groups
11150760|NCT01879319|FG000|Participant Flow|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
11150761|NCT01879319|FG001|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
11150762|NCT01879319|OG000|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
11150763|NCT01879319|OG001|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
11150764|NCT01879319|EG000|Reported Event|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
11150765|NCT01879319|EG001|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
11150766|NCT01879332|BG000|Baseline|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
11150767|NCT01879332|BG001|Baseline|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
11150768|NCT01879332|BG002|Baseline|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
11150769|NCT01879332|BG003|Baseline|Total|Total of all reporting groups
11150770|NCT01879332|FG000|Participant Flow|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
11150771|NCT01879332|FG001|Participant Flow|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
11150772|NCT01879332|FG002|Participant Flow|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
11150773|NCT01879332|OG000|Outcome|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
11150774|NCT01879332|OG001|Outcome|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
11150775|NCT01879332|OG002|Outcome|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
11150776|NCT01879332|EG000|Reported Event|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
11150777|NCT01879332|EG001|Reported Event|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
11150778|NCT01879332|EG002|Reported Event|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
11150779|NCT01879345|BG000|Baseline|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
11150780|NCT01879345|BG001|Baseline|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
11150781|NCT01879345|BG002|Baseline|Placebo|PLC, Placebo
11150782|NCT01879345|BG003|Baseline|Total|Total of all reporting groups
11150783|NCT01879345|FG000|Participant Flow|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
11150784|NCT01879345|FG001|Participant Flow|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
11150785|NCT01879345|FG002|Participant Flow|Placebo|PLC, Placebo
11150786|NCT01879345|OG000|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
11150787|NCT01879345|OG001|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
11150788|NCT01879345|OG002|Outcome|Placebo|PLC, Placebo
11150789|NCT01879345|OG000|Outcome|BIA 2-093 - 1800 mg (Group 1)|3 tablets of BIA 2-093 600 mg BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
11150790|NCT01879345|OG001|Outcome|BIA 2-093 - 2400 mg (Group 2)|4 tablets of BIA 2-093 600 mg BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg Oxcarbazepine is a BIA 2-093 metabolite
11150791|NCT01879345|EG000|Reported Event|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
11150792|NCT01879345|EG001|Reported Event|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
11150793|NCT01879345|EG002|Reported Event|Placebo|PLC, Placebo
11150794|NCT01879371|BG000|Baseline|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150795|NCT01879371|BG001|Baseline|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150796|NCT01879371|BG002|Baseline|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150797|NCT01879371|BG003|Baseline|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150798|NCT01879371|BG004|Baseline|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150799|NCT01879371|BG005|Baseline|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150800|NCT01879371|BG006|Baseline|Total|Total of all reporting groups
11150801|NCT01879371|FG000|Participant Flow|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150802|NCT01879371|FG001|Participant Flow|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150803|NCT01879371|FG002|Participant Flow|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150804|NCT01879371|FG003|Participant Flow|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150805|NCT01879371|FG004|Participant Flow|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150806|NCT01879371|FG005|Participant Flow|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
11150807|NCT01879371|OG000|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
11150808|NCT01879371|OG001|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
11150809|NCT01879371|OG002|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
11150810|NCT01879371|EG000|Reported Event|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
11150811|NCT01879371|EG001|Reported Event|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
11150812|NCT01879371|EG002|Reported Event|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
11150813|NCT01879410|BG000|Baseline|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
11150814|NCT01879410|BG001|Baseline|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
11150815|NCT01879410|BG002|Baseline|Total|Total of all reporting groups
11150816|NCT01879410|FG000|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg)) once daily (QD) in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI for 12 weeks.
11150817|NCT01879410|FG001|Participant Flow|FSC 250/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 250/50 µg twice daily (BID) in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
11150818|NCT01879410|OG000|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
11150819|NCT01879410|OG001|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
11150820|NCT01879410|EG000|Reported Event|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
11150821|NCT01879410|EG001|Reported Event|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
11150822|NCT01879540|BG000|Baseline|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
11150823|NCT01879540|FG000|Participant Flow|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
11150824|NCT01879540|OG000|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
11150825|NCT01879540|EG000|Reported Event|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
11150826|NCT01879553|BG000|Baseline|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
11150827|NCT01879553|BG001|Baseline|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
11150828|NCT01879553|BG002|Baseline|Total|Total of all reporting groups
11150829|NCT01879553|FG000|Participant Flow|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
11150830|NCT01879553|FG001|Participant Flow|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
11150831|NCT01879553|OG000|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
11150832|NCT01879553|OG001|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
11150833|NCT01879553|EG000|Reported Event|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
11150834|NCT01879553|EG001|Reported Event|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
11150835|NCT01879553|EG002|Reported Event|Total|Total
11150836|NCT01879579|BG000|Baseline|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
11150837|NCT01879579|BG001|Baseline|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
11150838|NCT01879579|BG002|Baseline|Total|Total of all reporting groups
11150839|NCT01879579|FG000|Participant Flow|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
11150840|NCT01879579|FG001|Participant Flow|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
11150841|NCT01879579|OG000|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
11150842|NCT01879579|OG001|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
11150843|NCT01879579|OG000|Outcome|Insulin Titration Visits by Phone|Insulin titration visits that occurred over the phone in both study arms (MITI and CBP arms).
11150844|NCT01879579|OG001|Outcome|Insulin Titration Visits in the Clinic|Insulin titration visits that occurred in the clinic in both study arms (MITI and CBP arms).
11150845|NCT01879579|OG000|Outcome|All Participants|Participants in both study arms (MITI and CBP).
11150846|NCT01879579|EG000|Reported Event|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
11150847|NCT01879579|EG001|Reported Event|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
11150848|NCT01879618|BG000|Baseline|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
11150849|NCT01879618|FG000|Participant Flow|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
11150850|NCT01879618|OG000|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
11150851|NCT01879618|EG000|Reported Event|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
11150852|NCT01879683|BG000|Baseline|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
11150853|NCT01879683|FG000|Participant Flow|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
11150854|NCT01879683|OG000|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
11150855|NCT01879683|EG000|Reported Event|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
11150856|NCT01879722|BG000|Baseline|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia
11150857|NCT01879722|BG001|Baseline|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150858|NCT01879722|BG002|Baseline|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150859|NCT01879722|BG003|Baseline|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150860|NCT01879722|BG004|Baseline|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150861|NCT01879722|BG005|Baseline|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150862|NCT01879722|BG006|Baseline|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150863|NCT01879722|BG007|Baseline|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150864|NCT01879722|BG008|Baseline|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150865|NCT01879722|BG009|Baseline|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150866|NCT01879722|BG010|Baseline|Total|Total of all reporting groups
11150867|NCT01879722|FG000|Participant Flow|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150868|NCT01879722|FG001|Participant Flow|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150869|NCT01879722|FG002|Participant Flow|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150870|NCT01879722|FG003|Participant Flow|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150871|NCT01879722|FG004|Participant Flow|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150872|NCT01879722|FG005|Participant Flow|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150873|NCT01879722|FG006|Participant Flow|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150874|NCT01879722|FG007|Participant Flow|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150875|NCT01879722|FG008|Participant Flow|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150876|NCT01879722|FG009|Participant Flow|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150877|NCT01879722|OG000|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150878|NCT01879722|OG001|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150879|NCT01879722|OG002|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150880|NCT01879722|OG003|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150881|NCT01879722|OG004|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150882|NCT01879722|OG005|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150883|NCT01879722|OG006|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150884|NCT01879722|OG007|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150885|NCT01879722|OG008|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150886|NCT01879722|OG009|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150887|NCT01879722|OG005|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150888|NCT01879722|OG006|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150889|NCT01879722|OG007|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150890|NCT01879722|EG000|Reported Event|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150891|NCT01879722|EG001|Reported Event|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150892|NCT01879722|EG002|Reported Event|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150893|NCT01879722|EG003|Reported Event|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150894|NCT01879722|EG004|Reported Event|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150895|NCT01879722|EG005|Reported Event|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
11150896|NCT01879722|EG006|Reported Event|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150897|NCT01879722|EG007|Reported Event|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150898|NCT01879722|EG008|Reported Event|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
11150899|NCT01879722|EG009|Reported Event|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
11173759|NCT02017327|EG000|Reported Event|Monoprost|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis."
11173760|NCT02017327|EG001|Reported Event|Lumigan 0.01%|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Lumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container."
11173761|NCT02017327|EG002|Reported Event|Lumigan 0.03% Unit Dose|"1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.~Lumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers."
11173762|NCT02017444|BG000|Baseline|Placebo|"Matched placebo tablet B.D for 12 weeks~Placebo: Matched placebo (matched to AZD4017 arm)"
11173763|NCT02017444|BG001|Baseline|AZD4017 (11b-HSD1 Inhibitor)|"AZD4017 400mg tablet B.D. for 12 weeks~AZD4017"
11173764|NCT02017444|BG002|Baseline|Total|Total of all reporting groups
11173765|NCT02017444|FG000|Participant Flow|Placebo|"Matched placebo tablet B.D for 12 weeks~Placebo: Matched placebo (matched to AZD4017 arm)"
11173766|NCT02017444|FG001|Participant Flow|AZD4017 (11b-HSD1 Inhibitor)|"AZD4017 400mg tablet B.D. for 12 weeks~AZD4017"
11173767|NCT02017444|OG000|Outcome|Placebo|"Matched placebo tablet B.D for 12 weeks~Placebo: Matched placebo (matched to AZD4017 arm)"
11173768|NCT02017444|OG001|Outcome|AZD4017 (11b-HSD1 Inhibitor)|"AZD4017 400mg tablet B.D. for 12 weeks~AZD4017"
11173769|NCT02017444|EG000|Reported Event|Placebo|"Matched placebo tablet B.D for 12 weeks~Placebo: Matched placebo (matched to AZD4017 arm)"
11173770|NCT02017444|EG001|Reported Event|AZD4017 (11b-HSD1 Inhibitor)|"AZD4017 400mg tablet B.D. for 12 weeks~AZD4017"
11173771|NCT02017535|BG000|Baseline|6 IPT-A Sessions|"IPT Only~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression."
11150900|NCT04838054|BG000|Baseline|Test - Stabilized Chlorine Dioxide Rinse|"Subjects will receive CloSYS Ultra Sensitive Rinse~Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy."
11150901|NCT04838054|BG001|Baseline|Placebo - Oral Rinse, no Active Ingredients|"Subjects will receive oral rinse - no active ingredients~Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy."
11150902|NCT04838054|BG002|Baseline|Total|Total of all reporting groups
11150903|NCT04838054|FG000|Participant Flow|Test - Stabilized Chlorine Dioxide Rinse|"Subjects will receive CloSYS Ultra Sensitive Rinse~Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy."
11150904|NCT04838054|FG001|Participant Flow|Placebo - Oral Rinse, no Active Ingredients|"Subjects will receive oral rinse - no active ingredients~Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy."
11150905|NCT04838054|OG000|Outcome|Test - Stabilized Chlorine Dioxide Rinse|"Subjects will receive CloSYS Ultra Sensitive Rinse~Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy."
11150906|NCT04838054|OG001|Outcome|Placebo - Oral Rinse, no Active Ingredients|"Subjects will receive oral rinse - no active ingredients~Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy."
11150907|NCT04838054|EG000|Reported Event|Test - Stabilized Chlorine Dioxide Rinse|"Subjects will receive CloSYS Ultra Sensitive Rinse~Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy."
11150908|NCT04838054|EG001|Reported Event|Placebo - Oral Rinse, no Active Ingredients|"Subjects will receive oral rinse - no active ingredients~Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy."
11150909|NCT04495829|BG000|Baseline|Phorcides|"Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.~Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine."
11150910|NCT04495829|FG000|Participant Flow|Phorcides|"Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.~Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine."
11150911|NCT04495829|OG000|Outcome|Phorcides|"Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.~Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine."
11150912|NCT04495829|EG000|Reported Event|Phorcides|"Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.~Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine."
11150913|NCT03861052|BG000|Baseline|5 mg Tirzepatide|Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks.
11150914|NCT03861052|BG001|Baseline|10 mg Tirzepatide|Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks
11150915|NCT03861052|BG002|Baseline|15 mg Tirzepatide|Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.
11150916|NCT03861052|BG003|Baseline|0.75 mg Dulaglutide|Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks
11150917|NCT03861052|BG004|Baseline|Total|Total of all reporting groups
11150918|NCT03861052|FG000|Participant Flow|5 mg Tirzepatide|Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks.
11150919|NCT03861052|FG001|Participant Flow|10 mg Tirzepatide|Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.
11150920|NCT03861052|FG002|Participant Flow|15 mg Tirzepatide|Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.
11150921|NCT03861052|FG003|Participant Flow|0.75 mg Dulaglutide|Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks
11150922|NCT03861052|OG000|Outcome|5 mg Tirzepatide|Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks.
11150923|NCT03861052|OG001|Outcome|10 mg Tirzepatide|Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.
11150924|NCT03861052|OG002|Outcome|15 mg Tirzepatide|Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.
11150925|NCT03861052|OG003|Outcome|0.75 mg Dulaglutide|Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks
11150926|NCT03861052|OG002|Outcome|15 mg Tirzepatide|Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks..
11150927|NCT03861052|OG000|Outcome|5 mg Tirzepatide|Participants received 5 mg tirzepatide administered SC once weekly for 52 week
11150928|NCT03861052|OG001|Outcome|10 mg Tirzepatide|Participants received 10 mg tirzepatide administered SC once weekly for 52 week
11150929|NCT03861052|OG002|Outcome|15 mg Tirzepatide|Participants received 15 mg tirzepatide administered SC once weekly for 52 week
11150930|NCT03861052|OG003|Outcome|0.75 mg Dulaglutide|Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.
11150931|NCT03861052|EG000|Reported Event|5 mg Tirzepatide|Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks.
11150932|NCT03861052|EG001|Reported Event|10 mg Tirzepatide|Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.
11150933|NCT03861052|EG002|Reported Event|15 mg Tirzepatide|Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.
11150934|NCT03861052|EG003|Reported Event|0.75 mg Dulaglutide|Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.
11150935|NCT03846453|BG000|Baseline|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
11150936|NCT03846453|BG001|Baseline|Placebo|Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
11150937|NCT03846453|BG002|Baseline|Total|Total of all reporting groups
11150938|NCT03846453|FG000|Participant Flow|Placebo-Run in Participants|All participants entered placebo-run in period for 14 days prior to randomization. During the period, exposures to the CAE were conducted to ascertain eligibility to enter the study. Those who qualified were randomized to either 0.25% HL036 Ophthalmic Solution group or placebo group.
11150939|NCT03846453|FG001|Participant Flow|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment (CAE®) were conducted at Day 1, Day 15, Day 29 and Day 57.
11150940|NCT03846453|FG002|Participant Flow|Placebo|Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
11150941|NCT03846453|OG000|Outcome|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
11150942|NCT03846453|OG001|Outcome|Placebo|Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
11150943|NCT03846453|OG000|Outcome|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
11150944|NCT03846453|OG001|Outcome|Placebo|Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
11150945|NCT03846453|EG000|Reported Event|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
11150946|NCT03846453|EG001|Reported Event|Placebo|Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
11150947|NCT03605862|BG000|Baseline|Nitazoxanide|Two Nitazoxanide 300 mg tablets orally twice daily for 5 days
11150948|NCT03605862|BG001|Baseline|Placebo|Two placebo tablets orally twice daily for 5 days
11150949|NCT03605862|BG002|Baseline|Total|Total of all reporting groups
11150950|NCT03605862|FG000|Participant Flow|Nitazoxanide|Two Nitazoxanide 300 mg tablets orally twice daily for 5 days
11150951|NCT03605862|FG001|Participant Flow|Placebo|Two placebo tablets orally twice daily for 5 days
11150952|NCT03605862|OG000|Outcome|Nitazoxanide|Two Nitazoxanide 300 mg tablets orally twice daily for 5 days
11150953|NCT03605862|OG001|Outcome|Placebo|Two placebo tablets orally twice daily for 5 days
11150954|NCT03605862|OG000|Outcome|ITTI Population|The intent-to-treat-infected (ITTI) population consisted of all subjects positive for EV/RV at Baseline.
11150955|NCT03605862|EG000|Reported Event|Nitazoxanide|Two Nitazoxanide 300 mg tablets orally twice daily for 5 days
11150956|NCT03605862|EG001|Reported Event|Placebo|Two placebo tablets orally twice daily for 5 days
11150957|NCT03541252|BG000|Baseline|Basal Cell Carcinoma Patients|"Patients (>18 years) with histologically-verified superficial or nodular basal cell carcinoma (<20 mm on the face/scalp, <50mm on the trunk/extremities)~AFL-assisted cisplatin+5-FU: Patients will receive AFL-assisted cisplatin+5-FU as a treatment for their BCC. In brief, treatment areas consisting of tumors and a 5 mm margin will undergo CO2 laser exposure followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) After removal of cisplatin, a commercially distributed 5-FU cream (5%) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off. An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30."
11150958|NCT03541252|FG000|Participant Flow|Basal Cell Carcinoma Patients|"Patients (>18 years) with histologically-verified superficial or nodular basal cell carcinoma (<20 mm on the face/scalp, <50mm on the trunk/extremities)~AFL-assisted cisplatin+5-FU: Patients will receive AFL-assisted cisplatin+5-FU as a treatment for their BCC. In brief, treatment areas consisting of tumors and a 5 mm margin will undergo CO2 laser exposure followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) After removal of cisplatin, a commercially distributed 5-FU cream (5%) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off. An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30."
11228062|NCT02388165|FG001|Participant Flow|Placebo|Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
11150959|NCT03541252|OG000|Outcome|Basal Cell Carcinoma Patients|"Patients (>18 years) with histologically-verified superficial or nodular basal cell carcinoma (<20 mm on the face/scalp, <50mm on the trunk/extremities)~AFL-assisted cisplatin+5-FU: Patients will receive AFL-assisted cisplatin+5-FU as a treatment for their BCC. In brief, treatment areas consisting of tumors and a 5 mm margin will undergo CO2 laser exposure followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) After removal of cisplatin, a commercially distributed 5-FU cream (5%) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off. An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30."
11150960|NCT03541252|EG000|Reported Event|Basal Cell Carcinoma Patients|"Patients (>18 years) with histologically-verified superficial or nodular basal cell carcinoma (<20 mm on the face/scalp, <50mm on the trunk/extremities)~AFL-assisted cisplatin+5-FU: Patients will receive AFL-assisted cisplatin+5-FU as a treatment for their BCC. In brief, treatment areas consisting of tumors and a 5 mm margin will undergo CO2 laser exposure followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) After removal of cisplatin, a commercially distributed 5-FU cream (5%) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off. An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30."
11173772|NCT02017535|BG001|Baseline|6 IPT-A Sessions + Continue Current Dose of Fluoxetine|"IPT with continued current fluoxetine dosage~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173773|NCT02017535|BG002|Baseline|10 IPT-A Sessions + Begin Fluoxetine|"IPT with new fluoxetine use~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173774|NCT02017535|BG003|Baseline|10 IPT-A Sessions + Increase Dose of Fluoxetine|"IPT with increased dose of fluoxetine~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173775|NCT02017535|BG004|Baseline|Total|Total of all reporting groups
11173776|NCT02017535|FG000|Participant Flow|6 IPT-A Sessions|"IPT Only~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression."
11173777|NCT02017535|FG001|Participant Flow|6 IPT-A Sessions + Continue Current Dose of Fluoxetine|"IPT with continued current fluoxetine dosage~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173778|NCT02017535|FG002|Participant Flow|10 IPT-A Sessions + Begin Fluoxetine|"IPT with new fluoxetine use~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173779|NCT02017535|FG003|Participant Flow|10 IPT-A Sessions + Increase Dose of Fluoxetine|"IPT with increased dose of fluoxetine~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173780|NCT02017535|OG000|Outcome|6 IPT-A Sessions|"IPT Only~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression."
11173781|NCT02017535|OG001|Outcome|6 IPT-A Sessions + Continue Current Dose of Fluoxetine|"IPT with continued current fluoxetine dosage~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173782|NCT02017535|OG002|Outcome|10 IPT-A Sessions + Begin Fluoxetine|"IPT with new fluoxetine use~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11228063|NCT02388165|OG000|Outcome|Staphylococcus Aureus 4-antigen (SA4Ag)|Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
11150961|NCT03401112|BG000|Baseline|IMR-687 50 mg/100 mg (Without HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
11150962|NCT03401112|BG001|Baseline|IMR-687 100 mg/200 mg (Without HU)|A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
11150963|NCT03401112|BG002|Baseline|Placebo (Without HU)|Matching placebo was administered to participants who were not receiving daily HU.
11150964|NCT03401112|BG003|Baseline|IMR-687 50 mg/100 mg (With HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150965|NCT03401112|BG004|Baseline|Placebo (With HU)|Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150966|NCT03401112|BG005|Baseline|Total|Total of all reporting groups
11150967|NCT03401112|FG000|Participant Flow|IMR-687 50 mg/100 mg (Without HU)|A starting dose of IMR-687 50 milligrams (mg) with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily hydroxyurea (HU).
11150968|NCT03401112|FG001|Participant Flow|IMR-687 100 mg/200 mg (Without HU)|A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
11150969|NCT03401112|FG002|Participant Flow|Placebo (Without HU)|Matching placebo was administered to participants who were not receiving daily HU.
11150970|NCT03401112|FG003|Participant Flow|IMR-687 50 mg/100 mg (With HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150971|NCT03401112|FG004|Participant Flow|Placebo (With HU)|Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150972|NCT03401112|OG000|Outcome|IMR-687 50 mg/100 mg (Without HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
11150973|NCT03401112|OG001|Outcome|IMR-687 100 mg/200 mg (Without HU)|A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
11150974|NCT03401112|OG002|Outcome|Placebo (Without HU)|Matching placebo was administered to participants who were not receiving daily HU.
10851392|NCT00306202|OG002|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
11150975|NCT03401112|OG003|Outcome|IMR-687 50 mg/100 mg (With HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150976|NCT03401112|OG004|Outcome|Placebo (With HU)|Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150977|NCT03401112|OG005|Outcome|All IMR-687|All participants who received IMR-687.
11150978|NCT03401112|OG006|Outcome|All Placebo|All participants who received placebo.
11150979|NCT03401112|OG000|Outcome|IMR-687 50 mg/100 mg (With HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150980|NCT03401112|OG000|Outcome|IMR-687 50 mg/100 mg (With HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were also receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150981|NCT03401112|OG001|Outcome|Placebo (With HU)|Participants who were receiving daily HU were administered placebo. HU doses ranged from 500 to 2000 mg.
11150982|NCT03401112|OG002|Outcome|Pooled IMR-687 (Without HU)|All participants administered IMR-687 who were not receiving daily HU.
11150983|NCT03401112|OG003|Outcome|Placebo (Without HU)|Matching placebo was administered to participants who were not receiving daily HU.
11150984|NCT03401112|OG004|Outcome|IMR-687 50 mg/100 mg (With HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150985|NCT03401112|OG005|Outcome|Placebo (With HU)|Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150986|NCT03401112|OG000|Outcome|IMR-687 50 mg/100 mg|All participants who had a starting dose of IMR-687 50 mg (with HU and without HU) with dose escalation up to 100 mg was administered.
11150987|NCT03401112|OG001|Outcome|IMR-687 100 mg/200 mg|All participants who had a starting dose of IMR-687 100 mg with dose escalation up to 200 mg was administered.
11150988|NCT03401112|OG002|Outcome|All IMR-687|All participants who received IMR-687.
11150989|NCT03401112|OG003|Outcome|All Placebo|All participants who received placebo.
11150990|NCT03401112|EG000|Reported Event|IMR-687 50 mg/100 mg (Without HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
11150991|NCT03401112|EG001|Reported Event|IMR-687 100 mg/200 mg (Without HU)|A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
11150992|NCT03401112|EG002|Reported Event|Placebo (Without HU)|Matching placebo was administered to participants who were not receiving daily HU.
11150993|NCT03401112|EG003|Reported Event|IMR-687 50 mg/100 mg (With HU)|A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150994|NCT03401112|EG004|Reported Event|Placebo (With HU)|Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
11150995|NCT03401112|EG005|Reported Event|All IMR-687|All participants who received IMR-687.
11150996|NCT03401112|EG006|Reported Event|All Placebo|All participants who received placebo.
11150997|NCT03362112|BG000|Baseline|Patients With T2DM|Patients with type 2 diabetes
11150998|NCT03362112|FG000|Participant Flow|Patients With T2DM|Patients with type 2 diabetes
11150999|NCT03362112|OG000|Outcome|Patients With T2DM|Patients with type 2 diabetes
11151000|NCT03362112|EG000|Reported Event|Patients With T2DM|Patients with type 2 diabetes
11151001|NCT03158298|BG000|Baseline|Study Group|Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
11151002|NCT03158298|FG000|Participant Flow|Study Group|Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
11151003|NCT03158298|OG000|Outcome|Study Group|Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
11151004|NCT03158298|EG000|Reported Event|Study Group|82 mother-child pairs; women initially migrated from Bilharzia endemic countries
11151005|NCT03041701|BG000|Baseline|Phase 1 Dose Level 1 Dose Escalation Dasatinib 60 mg/m^2 Every Day (QD)/Ganitumab 18 mg/kg|"Phase 1 Dose Level 1 Dose Escalation: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151006|NCT03041701|BG001|Baseline|Phase 1 Dose Level 2 Dose Escalation Dasatinib 60 mg/m^2 Twice Daily (BID)/Ganitumab 18 mg/kg|"Phase 1 Dose Level 2 Dose Escalation: Dasatinib 60mg/m^2 by mouth (PO) twice a day (BID) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151007|NCT03041701|BG002|Baseline|Phase 2 Dose Level 1 Maximum Tolerated Dose Dasatinib 60 mg/m^2 Every Day (QD)/ Ganitumab 18 mg/kg|"Phase 2 Dose Level 1 Maximum Tolerated Dose: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151008|NCT03041701|BG003|Baseline|Total|Total of all reporting groups
11151009|NCT03041701|FG000|Participant Flow|Phase 1 Dose Level 1 Dose Escalation Dasatinib 60 mg/m^2 Every Day (QD)/Ganitumab 18 mg/kg|"Phase 1 Dose Level 1 Dose Escalation: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151010|NCT03041701|FG001|Participant Flow|Phase 1 Dose Level 2 Dose Escalation Dasatinib 60 mg/m^2 Twice Daily (BID)/Ganitumab 18 mg/kg|"Phase 1 Dose Level 2 Dose Escalation: Dasatinib 60mg/m^2 by mouth (PO) twice a day (BID) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151011|NCT03041701|FG002|Participant Flow|Phase 2 Dose Level 1 Maximum Tolerated Dose Dasatinib 60 mg/m^2 Every Day (QD)/ Ganitumab 18 mg/kg|"Phase 2 Dose Level 1 Maximum Tolerated Dose: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151012|NCT03041701|OG000|Outcome|All Participants|All participants on: Phase 1 Dose Level 1 and Phase 1 Dose Level 2.
11151013|NCT03041701|OG000|Outcome|Phase 1 Dose Level 1 Dose Escalation Dasatinib 60 mg/m^2 Every Day (QD)/Ganitumab 18 mg/kg|"Phase 1 Dose Level 1 Dose Escalation: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151014|NCT03041701|OG001|Outcome|Phase 2 Dose Level 1 Maximum Tolerated Dose Dasatinib 60 mg/m^2 Every Day (QD)/ Ganitumab 18 mg/kg|"Phase 2 Dose Level 1 Maximum Tolerated Dose: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151015|NCT03041701|OG001|Outcome|Phase 1 Dose Level 2 Dose Escalation Dasatinib 60 mg/m^2 Twice Daily (BID)/Ganitumab 18 mg/kg|"Phase 1 Dose Level 2 Dose Escalation: Dasatinib 60mg/m^2 by mouth (PO) twice a day (BID) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151016|NCT03041701|OG000|Outcome|Phase 2 Dose Level 1 Maximum Tolerated Dose Dasatinib 60 mg/m^2 Every Day (QD)/ Ganitumab 18 mg/kg|"Phase 2 Dose Level 1 Maximum Tolerated Dose: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151017|NCT03041701|OG002|Outcome|Phase 2 Dose Level 1 Maximum Tolerated Dose Dasatinib 60 mg/m^2 Every Day (QD)/ Ganitumab 18 mg/kg|"Phase 2 Dose Level 1 Maximum Tolerated Dose: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151018|NCT03041701|EG000|Reported Event|Phase 1 Dose Level 1 Dose Escalation Dasatinib 60 mg/m^2 Every Day (QD)/Ganitumab 18 mg/kg|"Phase 1 Dose Level 1 Dose Escalation: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151019|NCT03041701|EG001|Reported Event|Phase 1 Dose Level 2 Dose Escalation Dasatinib 60 mg/m^2 Twice Daily (BID)/Ganitumab 18 mg/kg|"Phase 1 Dose Level 2 Dose Escalation: Dasatinib 60mg/m^2 by mouth (PO) twice a day (BID) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151020|NCT03041701|EG002|Reported Event|Phase 2 Dose Level 1 Maximum Tolerated Dose Dasatinib 60 mg/m^2 Every Day (QD)/ Ganitumab 18 mg/kg|"Phase 2 Dose Level 1 Maximum Tolerated Dose: Dasatinib 60mg/m^2 by mouth (PO) every day (QD) at Day-7. Ganitumab 18mg/kg intravenous (IV) every two weeks starting at Day 0.~Cycle 1 is Day -7 to 27; all other cycles are Day 0 to 27"
11151021|NCT03000179|BG000|Baseline|Avelumab Monotherapy|"Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.~Avelumab: Avelumab through a vein once every 2 weeks"
11151022|NCT03000179|FG000|Participant Flow|Avelumab Monotherapy|"Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.~Avelumab: Avelumab through a vein once every 2 weeks"
11151023|NCT03000179|OG000|Outcome|Avelumab Monotherapy|"Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.~Avelumab: Avelumab through a vein once every 2 weeks"
11151024|NCT03000179|EG000|Reported Event|Avelumab Monotherapy|"Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.~Avelumab: Avelumab through a vein once every 2 weeks"
11151025|NCT02876835|BG000|Baseline|Daprodustat|Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).
11151026|NCT02876835|BG001|Baseline|Darbepoetin Alfa|Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
11151027|NCT02876835|BG002|Baseline|Total|Total of all reporting groups
11151028|NCT02876835|FG000|Participant Flow|Daprodustat|Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).
11151029|NCT02876835|FG001|Participant Flow|Darbepoetin Alfa|Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
11151030|NCT02876835|OG000|Outcome|Daprodustat|Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).
11151031|NCT02876835|OG001|Outcome|Darbepoetin Alfa|Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
11151032|NCT02876835|EG000|Reported Event|Run-in Period: Placebo|Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1).
11151033|NCT02876835|EG001|Reported Event|Daprodustat|Participants received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily from randomization (Day 1) up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).
11151034|NCT02876835|EG002|Reported Event|Darbepoetin Alfa|Participants received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) from randomization (Day 1) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
11151035|NCT02860039|BG000|Baseline|Group 1 - High Dose TIV|"Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.~Trivalent Influenza Vaccine: High dose Trivalent Influenza Vaccine given intramuscular~Laboratory Biomarker Analysis: Correlative studies"
11151036|NCT02860039|BG001|Baseline|Group 2 - Standard Dose QIV|"Patients receive standard dose QIV IM on day 0 and day 28.~Quadrivalent Influenza Vaccine: Standard dose Quadrivalent Influenza Vaccine given intramuscular~Laboratory Biomarker Analysis: Correlative studies"
11151037|NCT02860039|BG002|Baseline|Total|Total of all reporting groups
11151038|NCT02860039|FG000|Participant Flow|Group 1 - High Dose TIV|"Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.~Trivalent Influenza Vaccine: High dose Trivalent Influenza Vaccine given intramuscular~Laboratory Biomarker Analysis: Correlative studies"
11151039|NCT02860039|FG001|Participant Flow|Group 2 - Standard Dose QIV|"Patients receive standard dose QIV IM on day 0 and day 28.~Quadrivalent Influenza Vaccine: Standard dose Quadrivalent Influenza Vaccine given intramuscular~Laboratory Biomarker Analysis: Correlative studies"
11151040|NCT02860039|OG000|Outcome|Group 1 - High Dose TIV|"Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.~Trivalent Influenza Vaccine: High dose Trivalent Influenza Vaccine given intramuscular~Laboratory Biomarker Analysis: Correlative studies"
11151041|NCT02860039|OG001|Outcome|Group 2 - Standard Dose QIV|"Patients receive standard dose QIV IM on day 0 and day 28.~Quadrivalent Influenza Vaccine: Standard dose Quadrivalent Influenza Vaccine given intramuscular~Laboratory Biomarker Analysis: Correlative studies"
11151042|NCT02860039|EG000|Reported Event|Group 1 - High Dose TIV|"Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.~Trivalent Influenza Vaccine: High dose Trivalent Influenza Vaccine given intramuscular~Laboratory Biomarker Analysis: Correlative studies"
11151043|NCT02860039|EG001|Reported Event|Group 2 - Standard Dose QIV|"Patients receive standard dose QIV IM on day 0 and day 28.~Quadrivalent Influenza Vaccine: Standard dose Quadrivalent Influenza Vaccine given intramuscular~Laboratory Biomarker Analysis: Correlative studies"
11151044|NCT02743728|BG000|Baseline|All Infants|"Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed.~Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis.~Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability~General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state."
11151045|NCT02743728|FG000|Participant Flow|All Infants|"Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed.~Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis.~Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability~General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state."
11151046|NCT02743728|OG000|Outcome|All Infants|"Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed.~Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis.~Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability~General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state."
11151047|NCT02743728|EG000|Reported Event|All Infants|"Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed.~Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis.~Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability~General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state."
11151048|NCT02482389|BG000|Baseline|Single Arm 7 Gray (Gy) Fraction of Radiotherapy|"All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.~Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery."
11151049|NCT02482389|FG000|Participant Flow|Single Arm 7 Gray (Gy) Fraction of Radiotherapy|"All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.~Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery."
11151050|NCT02482389|OG000|Outcome|Single Arm 7 Gray (Gy) Fraction of Radiotherapy|"All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.~Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery."
11151051|NCT02482389|EG000|Reported Event|Single Arm 7 Gray (Gy) Fraction of Radiotherapy|"All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.~Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery."
11173783|NCT02017535|OG003|Outcome|10 IPT-A Sessions + Increase Dose of Fluoxetine|"IPT with increased dose of fluoxetine~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173784|NCT02017535|EG000|Reported Event|6 IPT-A Sessions|"IPT Only~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression."
11173785|NCT02017535|EG001|Reported Event|6 IPT-A Sessions + Continue Current Dose of Fluoxetine|"IPT with continued current fluoxetine dosage~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173786|NCT02017535|EG002|Reported Event|10 IPT-A Sessions + Begin Fluoxetine|"IPT with new fluoxetine use~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173787|NCT02017535|EG003|Reported Event|10 IPT-A Sessions + Increase Dose of Fluoxetine|"IPT with increased dose of fluoxetine~Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.~Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter."
11173788|NCT02017574|BG000|Baseline|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
11173789|NCT02017574|BG001|Baseline|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
11173790|NCT02017574|BG002|Baseline|Total|Total of all reporting groups
11173791|NCT02017574|FG000|Participant Flow|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
11173792|NCT02017574|FG001|Participant Flow|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
11173793|NCT02017574|OG000|Outcome|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
11173794|NCT02017574|OG001|Outcome|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
11151052|NCT02232282|BG000|Baseline|Minimal Acupuncture|This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.
11151053|NCT02232282|BG001|Baseline|Standard Acupuncture Treatment|This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.
11151054|NCT02232282|BG002|Baseline|Total|Total of all reporting groups
11151055|NCT02232282|FG000|Participant Flow|Minimal Acupuncture|This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.
11151056|NCT02232282|FG001|Participant Flow|Standard Acupuncture Treatment|This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.
11151057|NCT02232282|OG000|Outcome|Minimal Acupuncture|"Control Sham/Minimal Acupuncture: Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including minimal acupuncture, therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treat"
11151058|NCT02232282|OG001|Outcome|Standard Acupuncture Treatment|Standard acupuncture treatment: protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.
11151059|NCT02232282|OG000|Outcome|Minimal Acupuncture|"Fifteen (15) will be allocated in the control sham/minimal acupuncture + standard medical treatments of IC. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including minimal acupuncture, therefore, the control group will not be aware of receiving sham acupuncture.~Control Sham/Minimal Acupuncture: Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including minimal acupuncture, therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treatment protocols for women with pelvic pain and bladder complaints."
11151060|NCT02232282|OG001|Outcome|Standard Acupuncture Treatment|"Fifteen (15) will be allocated in the standard acupuncture treatment + medical management of IC. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.~standard acupuncture treatment: A standardized acupuncture treatment will be assigned, and both groups will receive 7 acupuncture treatments that follow a standardized protocol on classical acupuncture points, with or without mild electrical stimulation versus sham/minimal acupuncture. Acupuncture needles are single use, sterile and disposable. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied."
11151061|NCT02232282|OG000|Outcome|Minimal Acupuncture|This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.
11151062|NCT02232282|OG001|Outcome|Standard Acupuncture Treatment|This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.
11151063|NCT02232282|EG000|Reported Event|Minimal Acupuncture|This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.
11151064|NCT02232282|EG001|Reported Event|Standard Acupuncture Treatment|This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.
11151065|NCT01492361|BG000|Baseline|AMR101|AMR101: Parallel Assignment
11151066|NCT01492361|BG001|Baseline|Placebo|Placebo: Parallel Assignment
11151067|NCT01492361|BG002|Baseline|Total|Total of all reporting groups
11151068|NCT01492361|FG000|Participant Flow|AMR101|AMR101: Parallel Assignment
11151069|NCT01492361|FG001|Participant Flow|Placebo|Placebo: Parallel Assignment
11151070|NCT01492361|OG000|Outcome|AMR101|AMR101: Parallel Assignment
11151071|NCT01492361|OG001|Outcome|Placebo|Placebo: Parallel Assignment
11151072|NCT01492361|EG000|Reported Event|AMR101|AMR101: Parallel Assignment
11151073|NCT01492361|EG001|Reported Event|Placebo|Placebo: Parallel Assignment
11151074|NCT01296711|BG000|Baseline|RA0056 CDP6038 (Olokizumab) 120 mg q2w|CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151075|NCT01296711|BG001|Baseline|RA0056 CDP6038 (Olokizumab) 120 mg q4w|CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151076|NCT01296711|BG002|Baseline|RA0056 CDP6038 (Olokizumab) 240 mg q2w|CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151077|NCT01296711|BG003|Baseline|RA0056 CDP6038 (Olokizumab) 240 mg q4w|CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151078|NCT01296711|BG004|Baseline|RA0056 CDP6038 (Olokizumab) 60 mg q2w|CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151079|NCT01296711|BG005|Baseline|RA0056 CDP6038 (Olokizumab) 60 mg q4w|CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151080|NCT01296711|BG006|Baseline|RA0056 Placebo|Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151081|NCT01296711|BG007|Baseline|RA0056 Tocilizumab 8 mg/kg q4w|Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151082|NCT01296711|BG008|Baseline|Total|Total of all reporting groups
11151083|NCT01296711|FG000|Participant Flow|RA0056 CDP6038 (Olokizumab) 120 mg q2w|CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
11151084|NCT01296711|FG001|Participant Flow|RA0056 CDP6038 (Olokizumab) 120 mg q4w|CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151085|NCT01296711|FG002|Participant Flow|RA0056 CDP6038 (Olokizumab) 240 mg q2w|CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151086|NCT01296711|FG003|Participant Flow|RA0056 CDP6038 (Olokizumab) 240 mg q4w|CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151087|NCT01296711|FG004|Participant Flow|RA0056 CDP6038 (Olokizumab) 60 mg q2w|CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151088|NCT01296711|FG005|Participant Flow|RA0056 CDP6038 (Olokizumab) 60 mg q4w|CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151089|NCT01296711|FG006|Participant Flow|RA0056 Placebo|Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151090|NCT01296711|FG007|Participant Flow|RA0056 Tocilizumab 8 mg/kg q4w|Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151091|NCT01296711|OG000|Outcome|RA0056 CDP6038 (Olokizumab) 120 mg q2w|CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
11151092|NCT01296711|OG001|Outcome|RA0056 CDP6038 (Olokizumab) 120 mg q4w|CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151093|NCT01296711|OG002|Outcome|RA0056 CDP6038 (Olokizumab) 240 mg q2w|CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151094|NCT01296711|OG003|Outcome|RA0056 CDP6038 (Olokizumab) 240 mg q4w|CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151095|NCT01296711|OG004|Outcome|RA0056 CDP6038 (Olokizumab) 60 mg q2w|CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151096|NCT01296711|OG005|Outcome|RA0056 CDP6038 (Olokizumab) 60 mg q4w|CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151097|NCT01296711|OG006|Outcome|RA0056 Placebo|Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151098|NCT01296711|OG007|Outcome|RA0056 Tocilizumab 8 mg/kg q4w|Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151099|NCT01296711|EG000|Reported Event|RA0056 CDP6038 (Olokizumab) 120 mg q2w|CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151100|NCT01296711|EG001|Reported Event|RA0056 CDP6038 (Olokizumab) 120 mg q4w|CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151101|NCT01296711|EG002|Reported Event|RA0056 CDP6038 (Olokizumab) 240 mg q2w|CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056).
11151102|NCT01296711|EG003|Reported Event|RA0056 CDP6038 (Olokizumab) 240 mg q4w|CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151103|NCT01296711|EG004|Reported Event|RA0056 CDP6038 (Olokizumab) 60 mg q2w|CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151104|NCT01296711|EG005|Reported Event|RA0056 CDP6038 (Olokizumab) 60 mg q4w|CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151105|NCT01296711|EG006|Reported Event|RA0056 Placebo|Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151106|NCT01296711|EG007|Reported Event|RA0056 Tocilizumab 8 mg/kg q4w|Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
11151107|NCT00084656|BG000|Baseline|3.0 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151108|NCT00084656|BG001|Baseline|10 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151109|NCT00084656|BG002|Baseline|10 MG/KG IPILIMUMAB|HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
11151110|NCT00084656|BG003|Baseline|Total|Total of all reporting groups
11151111|NCT00084656|FG000|Participant Flow|3.0 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151112|NCT00084656|FG001|Participant Flow|10 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151113|NCT00084656|FG002|Participant Flow|10 MG/KG IPILIMUMAB|HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
11151114|NCT00084656|OG000|Outcome|3.0 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151115|NCT00084656|OG001|Outcome|10 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151116|NCT00084656|OG002|Outcome|10 MG/KG IPILIMUMAB|HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
11151117|NCT00084656|OG000|Outcome|10 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151118|NCT00084656|OG001|Outcome|10 MG/KG IPILIMUMAB|HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
11151119|NCT00084656|EG000|Reported Event|3.0 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151120|NCT00084656|EG001|Reported Event|10 MG/KG IPILIMUMAB + PEPTIDES|"HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.~Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations."
11151121|NCT00084656|EG002|Reported Event|10 MG/KG IPILIMUMAB|HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
11151122|NCT01879735|BG000|Baseline|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the rate constants for the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
11151123|NCT01879735|BG001|Baseline|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
11151124|NCT01879735|BG002|Baseline|Total|Total of all reporting groups
11151125|NCT01879735|FG000|Participant Flow|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
11151126|NCT01879735|FG001|Participant Flow|Bolus and Constant Infusion of 11C-CSar|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
11151127|NCT01879735|OG000|Outcome|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
11151128|NCT01879735|OG001|Outcome|Infusion Method|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
11151129|NCT01879735|EG000|Reported Event|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
11151130|NCT01879735|EG001|Reported Event|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
11151131|NCT01879800|BG000|Baseline|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
11151132|NCT01879800|BG001|Baseline|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
11151133|NCT01879800|BG002|Baseline|Total|Total of all reporting groups
11151134|NCT01879800|FG000|Participant Flow|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
11151135|NCT01879800|FG001|Participant Flow|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
11151136|NCT01879800|OG000|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
11151137|NCT01879800|OG001|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
11151138|NCT01879800|EG000|Reported Event|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
11151139|NCT01879800|EG001|Reported Event|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
11151140|NCT01879826|BG000|Baseline|Aculaser Applied to Sham Points|"The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.~Aculaser applied to sham points: The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
11151141|NCT01879826|BG001|Baseline|Aculaser Applied to Kidney Points|"The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.~Aculaser applied to kidney points: The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
11151142|NCT01879826|BG002|Baseline|Total|Total of all reporting groups
11151143|NCT01879826|FG000|Participant Flow|Aculaser Applied to Sham Points|"The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.~Aculaser applied to sham points: The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
11151144|NCT01879826|FG001|Participant Flow|Aculaser Applied to Kidney Points|"The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.~Aculaser applied to kidney points: The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
11173795|NCT02017574|EG000|Reported Event|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
11151145|NCT01879826|OG000|Outcome|Aculaser Applied to Sham Points|"The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.~Aculaser applied to sham points: The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
11151146|NCT01879826|OG001|Outcome|Aculaser Applied to Kidney Points|"The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.~Aculaser applied to kidney points: The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
11151147|NCT01879826|EG000|Reported Event|Aculaser Applied to Sham Points|"The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.~Aculaser applied to sham points: The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
11151148|NCT01879826|EG001|Reported Event|Aculaser Applied to Kidney Points|"The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.~Aculaser applied to kidney points: The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
11151149|NCT01879852|BG000|Baseline|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
11151150|NCT01879852|BG001|Baseline|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
11151151|NCT01879852|BG002|Baseline|Total|Total of all reporting groups
11151152|NCT01879852|FG000|Participant Flow|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
11151153|NCT01879852|FG001|Participant Flow|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
11151154|NCT01879852|OG000|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
11151155|NCT01879852|OG001|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
11151156|NCT01879852|EG000|Reported Event|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
11173796|NCT02017574|EG001|Reported Event|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
11151157|NCT01879852|EG001|Reported Event|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
11151158|NCT01880047|BG000|Baseline|Non-splenectomized Active Drug|Includes patients on active drug who have not been splenectomized
11151159|NCT01880047|BG001|Baseline|Non-splenectomized Placebo|Includes patients on placebo who have not been splenectomized
11151160|NCT01880047|BG002|Baseline|Splectomized on Active Drug|Includes patients on active drug who have been splenectomized
11151161|NCT01880047|BG003|Baseline|Splectomized on Placebo|Includes patients on placebo who have been splenectomized
11151162|NCT01880047|BG004|Baseline|Total|Total of all reporting groups
11151163|NCT01880047|FG000|Participant Flow|Non-Splenectomized Eltrombopag|Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
11151164|NCT01880047|FG001|Participant Flow|Non-Splenectomized Placebo|Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
11151165|NCT01880047|FG002|Participant Flow|Splenectomized Eltrombopag|Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
11151166|NCT01880047|FG003|Participant Flow|Splenectomized Placebo|Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
11151167|NCT01880047|OG000|Outcome|Non-Splenectomized Eltrombopag|Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
11151168|NCT01880047|OG001|Outcome|Non-Splenectomized Placebo|Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
11151169|NCT01880047|OG002|Outcome|Splenectomized Eltrombopag|Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
11151170|NCT01880047|OG003|Outcome|Splenectomized Placebo|Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
11151171|NCT01880047|EG000|Reported Event|Non-Splenectomized Eltrombopag|Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
11151172|NCT01880047|EG001|Reported Event|Non-Splenectomized Placebo|Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
11151173|NCT01880047|EG002|Reported Event|Splenectomized Eltrombopag|Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
11151174|NCT01880047|EG003|Reported Event|Splenectomized Placebo|Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
11151175|NCT01880047|EG004|Reported Event|Eltrombopag 100 mg|This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 100 mg dose
11151176|NCT01880047|EG005|Reported Event|Eltombopag 125|This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 125 mg dose
11151177|NCT01880047|EG006|Reported Event|Eltombopag 150|This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 150 mg dose
11151178|NCT01880047|EG007|Reported Event|Placebo 100|This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 100 mg dose
11151179|NCT01880047|EG008|Reported Event|Placebo 125|This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 125 mg dose
11151180|NCT01880047|EG009|Reported Event|Placebo 150|This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 150 mg dose
11151181|NCT01880047|EG010|Reported Event|Open Label Phase|Subjects included are those who were on placebo and those who were on eltrombopag, all at 150 mg dose
11151182|NCT01880073|BG000|Baseline|FemVue Device|"FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective.~FemVue device: The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective."
11151183|NCT01880073|FG000|Participant Flow|FemVue Device|"FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective.~FemVue device: The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective."
11151184|NCT01880073|OG000|Outcome|FemVue Device|"FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective.~FemVue device: The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective."
11151185|NCT01880073|EG000|Reported Event|FemVue Device|"FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective.~FemVue device: The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective."
11151186|NCT01880086|BG000|Baseline|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
11173797|NCT02017860|BG000|Baseline|Everolimus|Patients who received everolimus in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol and were unable to access everolimus treatment outside of a clinical trial were enrolled.
11151187|NCT01880086|BG001|Baseline|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
11151188|NCT01880086|BG002|Baseline|Total|Total of all reporting groups
11151189|NCT01880086|FG000|Participant Flow|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
11151190|NCT01880086|FG001|Participant Flow|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
11151191|NCT01880086|OG000|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
11151192|NCT01880086|OG001|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
11151193|NCT01880086|EG000|Reported Event|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
11151194|NCT01880086|EG001|Reported Event|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
11151195|NCT01880099|BG000|Baseline|Placebo|"Placebo (sugar Pill) will be given daily for 7 weeks.~placebo: placebo compared to 8mg of galatamine"
11151196|NCT01880099|BG001|Baseline|Galantamine 8mg|"Galantamine extended release (8mg) will be given daily for 7 weeks.~Galantamine 8mg: 8mg of galatamine compared to placebo"
11151197|NCT01880099|BG002|Baseline|Galantamine 16mg|"Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.~Galantamine 16mg: 16mg of galatamine compared to placebo"
11151198|NCT01880099|BG003|Baseline|Total|Total of all reporting groups
11151199|NCT01880099|FG000|Participant Flow|Placebo|"Placebo (sugar Pill) will be given daily for 7 weeks.~placebo: placebo compared to 8mg of galatamine"
11151200|NCT01880099|FG001|Participant Flow|Galantamine 8mg|"Galantamine extended release (8mg) will be given daily for 7 weeks.~Galantamine 8mg: 8mg of galatamine compared to placebo"
11151201|NCT01880099|FG002|Participant Flow|Galantamine 16mg|"Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.~Galantamine 16mg: 16mg of galatamine compared to placebo"
11151202|NCT01880099|OG000|Outcome|Placebo|"Placebo (sugar Pill) will be given daily for 7 weeks.~placebo: placebo compared to 8mg of galatamine"
11151203|NCT01880099|OG001|Outcome|Galantamine 8mg|"Galantamine extended release (8mg) will be given daily for 7 weeks.~Galantamine 8mg: 8mg of galatamine compared to placebo"
11151204|NCT01880099|OG002|Outcome|Galantamine 16mg|"Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.~Galantamine 16mg: 16mg of galatamine compared to placebo"
11151205|NCT01880099|EG000|Reported Event|Placebo|"Placebo (sugar Pill) will be given daily for 7 weeks.~placebo: placebo compared to 8mg of galatamine"
11151206|NCT01880099|EG001|Reported Event|Galantamine 8mg|"Galantamine extended release (8mg) will be given daily for 7 weeks.~Galantamine 8mg: 8mg of galatamine compared to placebo"
11151207|NCT01880099|EG002|Reported Event|Galantamine 16mg|"Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.~Galantamine 16mg: 16mg of galatamine compared to placebo"
11151208|NCT01880320|BG000|Baseline|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
11151209|NCT01880320|BG001|Baseline|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
11151210|NCT01880320|BG002|Baseline|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
11151211|NCT01880320|BG003|Baseline|Total|Total of all reporting groups
11151212|NCT01880320|FG000|Participant Flow|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
11151213|NCT01880320|FG001|Participant Flow|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
11151214|NCT01880320|FG002|Participant Flow|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
11151215|NCT01880320|OG000|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
11151216|NCT01880320|OG001|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
11151217|NCT01880320|OG002|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
11151218|NCT01880320|EG000|Reported Event|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
10887667|NCT00502242|FG000|Participant Flow|Ramipril|Participants were receiving cyclosporine (CsA) or tacrolimus (TAC) and either mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) or steroids dosed per center's standard of care. Participants received ramipril, 5 or 10 milligrams per day (mg/d) orally (PO). 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of sirolimus [SRL] initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 nanograms per milliliter [ng/mL] less than [<]1 year post-transplant [PT], 5-15 ng/mL greater than or equal to [≥]1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if urinary protein to creatinine ratio (U p/c) was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
10887668|NCT00502242|FG001|Participant Flow|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center's standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
11151219|NCT01880320|EG001|Reported Event|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
11151220|NCT01880320|EG002|Reported Event|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
11151221|NCT01880424|BG000|Baseline|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
10887669|NCT00502242|OG000|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center's standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
10887670|NCT00502242|OG001|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center's standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
10887671|NCT00502242|EG000|Reported Event|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center's standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
10887672|NCT00502242|EG001|Reported Event|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center's standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
10887673|NCT00502307|BG000|Baseline|Open-label Period:Tivozanib (AV-951)|Subjects were enrolled into the initial, 16-week, open-label period and received tivozanib at a dose of 1.5 mg/day (oral administration). Subjects received tivozanib continuously for 3 weeks followed by 1 week off study drug (1 cycle = 3 weeks on, 1 week off). After 16 weeks (4 cycles), disease status was assessed and compared to baseline. Tivozanib was to be discontinued following disease progression or unacceptable toxicity.
10887674|NCT00502307|FG000|Participant Flow|Open-label Period: Tivozanib (AV-951)|Subjects were enrolled into the initial, 16-week, open-label period and received tivozanib at a dose of 1.5 mg/day (oral administration). Subjects received tivozanib continuously for 3 weeks followed by 1 week off study drug (1 cycle = 3 weeks on, 1 week off).
10887675|NCT00502307|FG001|Participant Flow|Double-blind Period: Tivozanib (AV-951)|Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive 1.5 mg/ day of tivozanib for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner.
10887676|NCT00502307|FG002|Participant Flow|Double-blind Period: Placebo|Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive matching placebo for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner.
11151222|NCT01880424|BG001|Baseline|Placebo Arm|matching placebo capsules, oral, once daily
11151223|NCT01880424|BG002|Baseline|Total|Total of all reporting groups
11151224|NCT01880424|FG000|Participant Flow|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
11151225|NCT01880424|FG001|Participant Flow|Placebo Arm|matching placebo capsules, oral, once daily
11151226|NCT01880424|OG000|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
11151227|NCT01880424|OG001|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
11088598|NCT01519635|EG000|Reported Event|Aliskiren|Aliskiren: Drug therapy has been started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
11088599|NCT01519635|EG001|Reported Event|Hydrochlorothiazide|"Hydrochlorothiazide: Drug therapy has been started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.~No side effect were observed and all patients finished the sudy in this treatment arm"
11088600|NCT01519648|BG000|Baseline|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
11088601|NCT01519648|BG001|Baseline|Allo- or Auto- Transplant Recipients|
11088602|NCT01519648|BG002|Baseline|Total|Total of all reporting groups
11151228|NCT01880424|EG000|Reported Event|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
11151229|NCT01880424|EG001|Reported Event|Placebo Arm|matching placebo capsules, oral, once daily
11088603|NCT01519648|FG000|Participant Flow|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
11088604|NCT01519648|FG001|Participant Flow|Allo- or Auto- Transplant Recipients|
11088605|NCT01519648|OG000|Outcome|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
11088606|NCT01519648|OG001|Outcome|Allo- or Auto- Transplant Recipients|Allo- or auto- transplant recipients
11088607|NCT01519648|EG000|Reported Event|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
11088608|NCT01519648|EG001|Reported Event|Allo- or Auto- Transplant Recipients|
11088609|NCT01519661|BG000|Baseline|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
11088610|NCT01519661|FG000|Participant Flow|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
11088611|NCT01519661|OG000|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
11088612|NCT01519661|OG000|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. Total number of isolates at each cycle/day: baseline = 279; cycle 1, day 29 = 252; cycle 2, day 85 = 238; cycle 3, day 141 = 210; cycle 4, day 197 = 184; cycle 5, day 253 = 178; cycle 6, day 309 = 164; and completion, day 337 = 158
11088613|NCT01519661|EG000|Reported Event|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
11088614|NCT01519674|BG000|Baseline|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
11088615|NCT01519674|BG001|Baseline|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
11088616|NCT01519674|BG002|Baseline|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
11088617|NCT01519674|BG003|Baseline|Total|Total of all reporting groups
11088618|NCT01519674|FG000|Participant Flow|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
11088619|NCT01519674|FG001|Participant Flow|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
11088620|NCT01519674|FG002|Participant Flow|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
11088621|NCT01519674|OG000|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
11088622|NCT01519674|OG001|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
11088623|NCT01519674|OG002|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
11088624|NCT01519674|EG000|Reported Event|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
11088625|NCT01519674|EG001|Reported Event|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
11088626|NCT01519674|EG002|Reported Event|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
11088627|NCT01519700|BG000|Baseline|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
11088628|NCT01519700|BG001|Baseline|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
11088629|NCT01519700|BG002|Baseline|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
11088630|NCT01519700|BG003|Baseline|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
11088631|NCT01519700|BG004|Baseline|Total|Total of all reporting groups
11088632|NCT01519700|FG000|Participant Flow|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously
11088633|NCT01519700|FG001|Participant Flow|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously
11088634|NCT01519700|FG002|Participant Flow|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously
11088635|NCT01519700|FG003|Participant Flow|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously
11088636|NCT01519700|OG000|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
11088637|NCT01519700|OG001|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
11088638|NCT01519700|OG000|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
11088639|NCT01519700|OG001|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
11088640|NCT01519700|OG002|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
11088641|NCT01519700|OG003|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
11088642|NCT01519700|OG004|Outcome|Total|All patients
11088643|NCT01519700|OG002|Outcome|Total|All patients in Cycle 1
11088644|NCT01519700|OG000|Outcome|EP2006 + Neupogen|All subjects randomized to receive either EP2006 or Neupogen.
11088645|NCT01519700|OG001|Outcome|EP2006 & Neupogen + Neupogen & EP2006|All subjects randomized to receive EP2006 & Neupogen + Neupogen & EP2006.
11088646|NCT01519700|EG000|Reported Event|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
11088647|NCT01519700|EG001|Reported Event|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
11088648|NCT01519700|EG002|Reported Event|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
11088649|NCT01519700|EG003|Reported Event|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
11088650|NCT01519713|BG000|Baseline|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
11088651|NCT01519713|BG001|Baseline|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
11088652|NCT01519713|BG002|Baseline|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
11088653|NCT01519713|BG003|Baseline|Total|Total of all reporting groups
11088654|NCT01519713|FG000|Participant Flow|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
11151230|NCT01880437|BG000|Baseline|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151231|NCT01880437|BG001|Baseline|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151232|NCT01880437|BG002|Baseline|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151233|NCT01880437|BG003|Baseline|Total|Total of all reporting groups
11151234|NCT01880437|FG000|Participant Flow|Poor Risk Cytogenetics|Participants with relapsed/refractory acute myeloid leukemia (AML) or relapsed/refractory high-risk myelodysplastic syndrome (MDS) falling under 'poor risk cytogenetics' subgroup received oral 150 milligrams (mg) dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151235|NCT01880437|FG001|Participant Flow|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151236|NCT01880437|FG002|Participant Flow|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151237|NCT01880437|OG000|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151238|NCT01880437|OG001|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151239|NCT01880437|OG002|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151240|NCT01880437|OG002|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151241|NCT01880437|OG000|Outcome|Planned Cohort 2|Participants in Cohort 2 were planned to receive low-dose subcutaneous injections of cytarabine in combination with continuous daily vismodegib (150 mg orally).
11151242|NCT01880437|EG000|Reported Event|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151243|NCT01880437|EG001|Reported Event|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151244|NCT01880437|EG002|Reported Event|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
11151245|NCT01880515|BG000|Baseline|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
11151246|NCT01880515|BG001|Baseline|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
11151247|NCT01880515|BG002|Baseline|Total|Total of all reporting groups
11151248|NCT01880515|FG000|Participant Flow|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 (afatinib)"
11151249|NCT01880515|FG001|Participant Flow|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
11151250|NCT01880515|OG000|Outcome|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
11151251|NCT01880515|OG001|Outcome|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
11151252|NCT01880515|OG000|Outcome|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 whereas the non-intervention group will recieve general dermatological recomendations while on treatment with BIBW2992."
11151253|NCT01880515|EG000|Reported Event|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
11151254|NCT01880515|EG001|Reported Event|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
11151255|NCT01880528|BG000|Baseline|Arm I (Lisinopril)|Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.
11151256|NCT01880528|BG001|Baseline|Arm II (Placebo)|Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
11151257|NCT01880528|BG002|Baseline|Total|Total of all reporting groups
11151258|NCT01880528|FG000|Participant Flow|Arm I (Lisinopril)|Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.
11151259|NCT01880528|FG001|Participant Flow|Arm II (Placebo)|Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
11151260|NCT01880528|OG000|Outcome|Arm I (Lisinopril)|Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.
11151261|NCT01880528|OG001|Outcome|Arm II (Placebo)|Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
11151262|NCT01880528|EG000|Reported Event|Arm I (Lisinopril)|Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.
11151263|NCT01880528|EG001|Reported Event|Arm II (Placebo)|Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
11151264|NCT01880554|BG000|Baseline|Contrast-enhanced Intraoperative Ultrasound|"Contrast-enhanced intraoperative ultrasound~Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:~Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages"
11151265|NCT01880554|FG000|Participant Flow|Contrast-enhanced Intraoperative Ultrasound|"Contrast-enhanced intraoperative ultrasound~Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:~Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages"
11151266|NCT01880554|OG000|Outcome|Contrast-enhanced Intraoperative Ultrasound|"Contrast-enhanced intraoperative ultrasound~Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:~Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages. Step #2 intraoperative ultrasound and step #3 Contrast-enhanced intraoperative ultrasound"
11151267|NCT01880554|OG000|Outcome|Contrast-enhanced Intraoperative Ultrasound|"Contrast-enhanced intraoperative ultrasound~Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:~Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages"
11151268|NCT01880554|EG000|Reported Event|Contrast-enhanced Intraoperative Ultrasound|"Contrast-enhanced intraoperative ultrasound~Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:~Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages"
11151269|NCT01880593|BG000|Baseline|Ketamine and Lithium|600-1200mg of Lithium pills at night for duration of the study
11151270|NCT01880593|BG001|Baseline|Ketamine and Placebo|Placebo pills at night for duration of the study
11151271|NCT01880593|BG002|Baseline|Total|Total of all reporting groups
11151272|NCT01880593|FG000|Participant Flow|Ketamine and Lithium|600-1200mg of Lithium pills at night for duration of the study
11151273|NCT01880593|FG001|Participant Flow|Ketamine and Placebo|Placebo pills at night for duration of the study
11151274|NCT01880593|OG000|Outcome|Ketamine and Lithium|600-1200mg of Lithium pills at night for duration of the study
11151275|NCT01880593|OG001|Outcome|Ketamine and Placebo|Placebo pills at night for duration of the study
11151276|NCT01880593|EG000|Reported Event|Ketamine and Lithium|600-1200mg of Lithium pills at night for duration of the study
11151277|NCT01880593|EG001|Reported Event|Ketamine and Placebo|Placebo pills at night for duration of the study
11151278|NCT01880697|BG000|Baseline|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
11151279|NCT01880697|BG001|Baseline|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
11151280|NCT01880697|BG002|Baseline|Total|Total of all reporting groups
11151281|NCT01880697|FG000|Participant Flow|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
11151282|NCT01880697|FG001|Participant Flow|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
11151283|NCT01880697|OG000|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
11151284|NCT01880697|OG001|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
11088655|NCT01519713|FG001|Participant Flow|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
11088656|NCT01519713|FG002|Participant Flow|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
11088657|NCT01519713|OG000|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
11088658|NCT01519713|OG001|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
11088659|NCT01519713|OG002|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
11088660|NCT01519713|EG000|Reported Event|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
11088661|NCT01519713|EG001|Reported Event|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
11088662|NCT01519713|EG002|Reported Event|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
11088663|NCT01519765|BG000|Baseline|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
11088664|NCT01519765|BG001|Baseline|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
11088665|NCT01519765|BG002|Baseline|Total|Total of all reporting groups
11088666|NCT01519765|FG000|Participant Flow|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
11088667|NCT01519765|FG001|Participant Flow|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
11088668|NCT01519765|OG000|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
11088669|NCT01519765|OG001|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
11088670|NCT01519765|OG000|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
11088671|NCT01519765|EG000|Reported Event|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
11088672|NCT01519765|EG001|Reported Event|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
11088673|NCT01519778|BG000|Baseline|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
11088674|NCT01519778|FG000|Participant Flow|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
11088675|NCT01519778|OG000|Outcome|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
11088676|NCT01519778|EG000|Reported Event|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
11088677|NCT01519791|BG000|Baseline|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088678|NCT01519791|BG001|Baseline|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088679|NCT01519791|BG002|Baseline|Total Title|
11088680|NCT01519791|FG000|Participant Flow|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088681|NCT01519791|FG001|Participant Flow|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088682|NCT01519791|OG000|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088683|NCT01519791|OG001|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11151285|NCT01880697|EG000|Reported Event|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
11088684|NCT01519791|OG000|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088685|NCT01519791|OG001|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088686|NCT01519791|EG000|Reported Event|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088687|NCT01519791|EG001|Reported Event|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
11088688|NCT01519817|BG000|Baseline|All Participants|"All participants who received at least one dose of 4YU, 16YU, 40YU or 80YU.~Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.~GI-6301 (Yeast Brachyury Vaccine): GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product."
11088689|NCT01519817|FG000|Participant Flow|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088690|NCT01519817|FG001|Participant Flow|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088691|NCT01519817|FG002|Participant Flow|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088692|NCT01519817|FG003|Participant Flow|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088693|NCT01519817|OG000|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088694|NCT01519817|OG001|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088695|NCT01519817|OG002|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088696|NCT01519817|OG003|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088697|NCT01519817|EG000|Reported Event|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088698|NCT01519817|EG001|Reported Event|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088699|NCT01519817|EG002|Reported Event|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088700|NCT01519817|EG003|Reported Event|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
11088701|NCT01519869|BG000|Baseline|Neoadjuvant Chemotherapy|"platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy~neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy"
11088702|NCT01519869|FG000|Participant Flow|Neoadjuvant Chemotherapy|"platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy~neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy"
11088703|NCT01519869|OG000|Outcome|Neoadjuvant Chemotherapy|"platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy~neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy"
11088704|NCT01519869|EG000|Reported Event|Neoadjuvant Chemotherapy|"platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy~neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy"
11088705|NCT01519882|BG000|Baseline|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
11151286|NCT01880697|EG001|Reported Event|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
11088706|NCT01519882|BG001|Baseline|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
11088707|NCT01519882|BG002|Baseline|Total|Total of all reporting groups
11088708|NCT01519882|FG000|Participant Flow|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
11088709|NCT01519882|FG001|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
11088710|NCT01519882|OG000|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
11088711|NCT01519882|OG001|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
11088712|NCT01519882|EG000|Reported Event|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
11088713|NCT01519882|EG001|Reported Event|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
11088714|NCT01519921|BG000|Baseline|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
11088715|NCT01519921|BG001|Baseline|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
11088716|NCT01519921|BG002|Baseline|Total|Total of all reporting groups
11088717|NCT01519921|FG000|Participant Flow|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
11088718|NCT01519921|FG001|Participant Flow|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
11088719|NCT01519921|OG000|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
11088720|NCT01519921|OG001|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
11088721|NCT01519921|EG000|Reported Event|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
11088722|NCT01519921|EG001|Reported Event|PEG-IFN Alfa-2a (YMDD Mutant)|Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.
11088723|NCT01519934|BG000|Baseline|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
11088724|NCT01519934|FG000|Participant Flow|Ulthera-treated Subjects|All enrolled subjects had received one Ulthera treatment on the face and neck at two treatment depths, 4.5mm and 3.0mm depths, prior to enrollment.
11088725|NCT01519934|OG000|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
11088726|NCT01519934|EG000|Reported Event|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
11088727|NCT01519947|BG000|Baseline|Pre-dialysis, Sea Level|Participants received 50-250 mcg SC according to local label.
11088728|NCT01519947|BG001|Baseline|Dialysis, Sea Level|Participants received 50-250 mcg SC according to local label.
11088729|NCT01519947|BG002|Baseline|Pre-dialysis, >1800 Meters|Participants received 50-250 mcg SC according to local label.
11088730|NCT01519947|BG003|Baseline|Dialysis, >1800 Meters|Participants received 50-250 mcg SC according to local label.
11088731|NCT01519947|BG004|Baseline|Total|Total of all reporting groups
11088732|NCT01519947|FG000|Participant Flow|Pre-dialysis, Sea Level|Participants received 50-250 mcg subcutaneously (SC) according to local label.
11088733|NCT01519947|FG001|Participant Flow|Dialysis, Sea Level|Participants received 50-250 mcg SC according to local label.
11088734|NCT01519947|FG002|Participant Flow|Pre-dialysis, >1800 Meters|Participants received 50-250 mcg SC according to local label.
11088735|NCT01519947|FG003|Participant Flow|Dialysis, >1800 Meters|Participants received 50-250 mcg SC according to local label.
11088736|NCT01519947|OG000|Outcome|Pre-dialysis, Sea Level|Participants received 50-250 mcg SC according to local label.
11151287|NCT01880723|BG000|Baseline|Healthy|Healthy Control subjects
11151288|NCT01880723|BG001|Baseline|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
11151289|NCT01880723|BG002|Baseline|Total|Total of all reporting groups
11151290|NCT01880723|FG000|Participant Flow|Healthy|Healthy control subjects
11151291|NCT01880723|FG001|Participant Flow|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
11151292|NCT01880723|OG000|Outcome|Healthy|Healthy control subjects
11151293|NCT01880723|OG001|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
11151294|NCT01880723|EG000|Reported Event|Healthy|Healthy control subjects
11151295|NCT01880723|EG001|Reported Event|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
11151296|NCT01880736|BG000|Baseline|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
11151297|NCT01880736|BG001|Baseline|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
11151298|NCT01880736|BG002|Baseline|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
11151299|NCT01880736|BG003|Baseline|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
11151300|NCT01880736|BG004|Baseline|Total|Total of all reporting groups
11151301|NCT01880736|FG000|Participant Flow|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
11151302|NCT01880736|FG001|Participant Flow|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
11151303|NCT01880736|FG002|Participant Flow|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
11151304|NCT01880736|FG003|Participant Flow|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
11151305|NCT01880736|OG000|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
11151306|NCT01880736|OG001|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
11151307|NCT01880736|OG002|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
11151308|NCT01880736|OG003|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
11173798|NCT02017860|FG000|Participant Flow|Everolimus|Patients who received everolimus in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol and were unable to access everolimus treatment outside of a clinical trial were enrolled.
11088737|NCT01519947|OG001|Outcome|Dialysis, Sea Level|Participants received 50-250 mcg SC according to local label.
11088738|NCT01519947|OG002|Outcome|Pre-dialysis, >1800 Meters|Participants received 50-250 mcg SC according to local label.
11088739|NCT01519947|OG003|Outcome|Dialysis, >1800 Meters|Participants received 50-250 mcg SC according to local label.
11088740|NCT01519947|EG000|Reported Event|Pre-dialysis, Sea Level|Participants received 50-250 mcg SC according to local label.
11088741|NCT01519947|EG001|Reported Event|Dialysis, Sea Level|Participants received 50-250 mcg SC according to local label.
11088742|NCT01519947|EG002|Reported Event|Pre-dialysis, >1800 Meters|Participants received 50-250 mcg SC according to local label.
11088743|NCT01519947|EG003|Reported Event|Dialysis, >1800 Meters|Participants received 50-250 mcg SC according to local label.
11088744|NCT01520038|BG000|Baseline|Adjuvant Radiation Therapy for the Treatment of Urothelial Bla|Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
11088745|NCT01520038|FG000|Participant Flow|Adjuvant Radiation Therapy for the Treatment of Urothelial Bla|Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
11088746|NCT01520038|OG000|Outcome|Adjuvant Radiation Therapy for the Treatment of Urothelial Bla|Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
11088747|NCT01520038|EG000|Reported Event|Adjuvant Radiation Therapy for the Treatment of Urothelial Bla|Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
11088748|NCT01520207|BG000|Baseline|Placebo Group: (0.9% Normal Saline)|"0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment"
11088749|NCT01520207|BG001|Baseline|Intervention: Intravenous Mannitol (20%)|"Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)"
11088750|NCT01520207|BG002|Baseline|Total|Total of all reporting groups
11088751|NCT01520207|FG000|Participant Flow|Placebo Group: (0.9% Normal Saline)|"0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment"
11088752|NCT01520207|FG001|Participant Flow|Intervention: Intravenous Mannitol (20%)|"Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)"
11088753|NCT01520207|OG000|Outcome|Placebo Group: (0.9% Normal Saline)|"0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment"
11088754|NCT01520207|OG001|Outcome|Intervention: Intravenous Mannitol (20%)|"Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)"
11088755|NCT01520207|EG000|Reported Event|Placebo Group: (0.9% Normal Saline)|"0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment"
11088756|NCT01520207|EG001|Reported Event|Intervention: Intravenous Mannitol (20%)|"Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)"
11088757|NCT01520324|BG000|Baseline|Patients With UC Undergoing Colonoscopy|oral delivery mucosal stain: 200mg methylene blue MMX tablet taken prior to colonoscopy
11088758|NCT01520324|FG000|Participant Flow|Patients With UC Undergoing Colonoscopy|oral delivery mucosal stain: 200mg methylene blue MMX tablet taken prior to colonoscopy
11088759|NCT01520324|OG000|Outcome|Full Analysis Set (FAS)|All enrolled subjects, who received at least one dose of the test investigational medicinal product and had at least one evaluation of the number of detected neoplasiae.
11088760|NCT01520324|EG000|Reported Event|Full Analysis Set (FAS)|All enrolled subjects, who received at least one dose of the test investigational medicinal product and had at least one evaluation of the number of detected neoplasiae.
11088761|NCT01520363|BG000|Baseline|Study Drug-dextromethorphan (DM)|"MECP2 mutation positive subjects randomized to receive DM~dextromethorphan: The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists will dispense the DM to the study participants."
11088762|NCT01520363|BG001|Baseline|Placebo Group|"MECP2 positive subjects randomized to the placebo compound~placebo: The placebo will be dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months. The Research pharmacist will dispense the placebo to the participants."
11088763|NCT01520363|BG002|Baseline|Total|Total of all reporting groups
11088764|NCT01520363|FG000|Participant Flow|Study Drug-dextromethorphan (DM)|"MECP2 mutation positive subjects randomized to receive DM~dextromethorphan: The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists will dispense the DM to the study participants."
11088765|NCT01520363|FG001|Participant Flow|Placebo Group|"MECP2 positive subjects randomized to the placebo compound~placebo: The placebo will be dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months. The Research pharmacist will dispense the placebo to the participants."
11088766|NCT01520363|OG000|Outcome|Study Drug-dextromethorphan (DM)|"MECP2 mutation positive subjects randomized to receive DM at baseline~dextromethorphan: The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists will dispense the DM to the study participants."
11088767|NCT01520363|OG001|Outcome|Placebo Group|"MECP2 positive subjects randomized to the placebo at baseline~placebo: The placebo will be dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months. The Research pharmacist will dispense the placebo to the participants."
11088768|NCT01520363|OG002|Outcome|Study Drug Group at 3 Months|MECP2 mutation positive subjects randomized to DM at 3 months
11088769|NCT01520363|OG003|Outcome|Placebo at 3 Months|MECP2 mutation positive subjects randomized to placebo at 3 months
11088770|NCT01520363|OG000|Outcome|Study Drug-dextromethorphan (DM)|MECP2 mutation positive subjects randomized to receive DM (dextromethorphan) at baseline: The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study.
11088771|NCT01520363|OG001|Outcome|Placebo Group|MECP2 positive subjects randomized to the placebo compound at baseline. The placebo will be dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months.
11088772|NCT01520363|OG002|Outcome|Study Drug-dextromethorphan (DM) at 3 Months|MECP2 mutation positive subjects randomized to receive DM (dextromethorphan) who completed study assessments at the 3 month time point.
11088773|NCT01520363|OG003|Outcome|Placebo Group at 3 Months|MECP2 positive subjects randomized to the placebo compound who completed the assessments at the 3 month time point.
11088774|NCT01520363|OG000|Outcome|Study Drug-dextromethorphan (DM)|MECP2 mutation positive subjects randomized to receive DM (dextromethorphan) at baseline: The DM group took 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study.
11088775|NCT01520363|OG001|Outcome|Placebo Group|MECP2 positive subjects randomized to the placebo compound at baseline: The placebo was dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months. The Research pharmacist dispensed the placebo to the participants.
11088776|NCT01520363|OG002|Outcome|Study Drug-dextromethorphan (DM) at 3 Months|MECP2 mutation positive subjects randomized to receive DM (dextromethorphan) who completed the study at 3 months
11088777|NCT01520363|OG003|Outcome|Placebo Group at 3 Months|MECP2 positive subjects randomized to the placebo compound were still active in the study at 3 months.
11088778|NCT01520363|OG000|Outcome|Study Drug-dextromethorphan (DM)|MECP2 mutation positive subjects randomized to receive DM (dextromethorphan) at baseline: The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists dispensed the DM to the study participants.
11088779|NCT01520363|OG002|Outcome|Study Drug-dextromethorphan (DM) at 3 Months|MECP2 mutation positive subjects randomized to receive DM (dextromethorphan) at 3 month time period.
11088780|NCT01520363|OG003|Outcome|Placebo Group at 3 Months|MECP2 mutation positive subjects randomized to receive DM placebo at 3 month time period.
11088781|NCT01520363|OG000|Outcome|Study Drug-dextromethorphan (DM)|MECP2 mutation positive subjects randomized to receive DM (dextromethorphan) at baseline: The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists will dispense the DM to the study participants.
11088782|NCT01520363|OG001|Outcome|Placebo Group|"MECP2 positive subjects randomized to the placebo compound~placebo: The placebo will be dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months. The Research pharmacist will dispense the placebo to the participants."
11088783|NCT01520363|OG002|Outcome|Study Drug-dextromethorphan (DM) at 3 Months|MECP2 mutation positive subjects randomized to receive DM (dextromethorphan) and active in study at 3 month time point.
11088784|NCT01520363|OG003|Outcome|Placebo Group at 3 Months|MECP2 mutation positive subjects randomized to receive Placebo and active in study at 3 month time point.
11088785|NCT01520363|OG000|Outcome|Study Drug-dextromethorphan (DM)|MECP2 mutation positive subjects randomized to receive dextromethorphan(DM) at baseline
11088786|NCT01520363|OG001|Outcome|Placebo Group|MECP2 positive subjects randomized to the placebo at baseline.
11088787|NCT01520363|OG000|Outcome|Study Drug-dextromethorphan (DM)|"MECP2 mutation positive subjects randomized to receive DM~dextromethorphan: The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists will dispense the DM to the study participants."
11088788|NCT01520363|OG002|Outcome|Study Drug-dextromethorphan (DM) at 3 Months|MECP2 mutation positive subjects randomized to DM at 3 months.
11088789|NCT01520363|OG003|Outcome|Placebo Group at 3 Months|MECP2 mutation positive subjects randomized to placebo at 3 months,
11088790|NCT01520363|EG000|Reported Event|Study Drug-dextromethorphan (DM)|MECP2 mutation positive subjects randomized to receive dextromethorphan(DM) at baseline
11088791|NCT01520363|EG001|Reported Event|Placebo Group|MECP2 positive subjects randomized to the placebo at baseline.
11088792|NCT01520363|EG002|Reported Event|Study Drug Group at 3 Months|MECP2 mutation positive subjects randomized to DM at 3 months
11088793|NCT01520363|EG003|Reported Event|Placebo at 3 Months|MECP2 mutation positive subjects randomized to placebo at 3 months
11088794|NCT01520402|BG000|Baseline|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.~Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
11151309|NCT01880736|EG000|Reported Event|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
11151310|NCT01880736|EG001|Reported Event|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
11151311|NCT01880736|EG002|Reported Event|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
11151312|NCT01880736|EG003|Reported Event|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
11151313|NCT01880840|BG000|Baseline|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
11151314|NCT01880840|BG001|Baseline|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
11151315|NCT01880840|BG002|Baseline|Total|Total of all reporting groups
11151316|NCT01880840|FG000|Participant Flow|Astepro 0.15%|azelastine hydrochloride 822mcg nasal spray
11151317|NCT01880840|FG001|Participant Flow|Astepro 0.1%|azelastine hydrochloride 548 mcg nasal spray
11151318|NCT01880840|OG000|Outcome|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
11151319|NCT01880840|OG001|Outcome|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
11151320|NCT01880840|EG000|Reported Event|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
11151321|NCT01880840|EG001|Reported Event|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
11151322|NCT01881009|BG000|Baseline|Inpatient Overnight|Overnight evaluation to test safety of the closed-loop system therapy device.
11151323|NCT01881009|BG001|Baseline|Summer Camp Session|Participants were considered to be a single group, receiving the same interventions, either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study.
11151324|NCT01881009|BG002|Baseline|Total|Total of all reporting groups
11151325|NCT01881009|FG000|Participant Flow|Inpatient Overnight|Overnight evaluation to test safety of the closed-loop system therapy device.
11151326|NCT01881009|FG001|Participant Flow|Summer Camp Session|Participants were considered to be a single group, receiving the same interventions, either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study. The sensor augmented pump was considered to be the control.
11151327|NCT01881009|OG000|Outcome|Closed Loop Nights|Data for nights that participants received closed loop controller treatment.
11151328|NCT01881009|OG001|Outcome|Control Nights|Data for nights that participants received sensor augmented pump treatment.
11151329|NCT01881009|OG000|Outcome|Inpatient Overnight|Overnight evaluation to test safety of the closed-loop system therapy device.
11151330|NCT01881009|EG000|Reported Event|Inpatient Overnight|Overnight evaluation to test safety of the closed-loop system therapy device.
11151331|NCT01881009|EG001|Reported Event|Summer Camp Session|Participants were considered to be a single group, receiving the same interventions, either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study.
11151332|NCT01881087|BG000|Baseline|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151333|NCT01881087|BG001|Baseline|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151334|NCT01881087|BG002|Baseline|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151335|NCT01881087|BG003|Baseline|Total|Total of all reporting groups
11151336|NCT01881087|FG000|Participant Flow|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151337|NCT01881087|FG001|Participant Flow|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151338|NCT01881087|FG002|Participant Flow|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151339|NCT01881087|OG000|Outcome|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151340|NCT01881087|OG001|Outcome|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151341|NCT01881087|OG002|Outcome|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151342|NCT01881087|EG000|Reported Event|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151343|NCT01881087|EG001|Reported Event|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151344|NCT01881087|EG002|Reported Event|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
11151345|NCT01881113|BG000|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11151346|NCT01881113|BG001|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11151347|NCT01881113|BG002|Baseline|Total|Total of all reporting groups
11151348|NCT01881113|FG000|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11151349|NCT01881113|FG001|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11151350|NCT01881113|OG000|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11151351|NCT01881113|OG001|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11151352|NCT01881113|EG000|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11151353|NCT01881113|EG001|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11151354|NCT01881126|BG000|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
11151355|NCT01881126|BG001|Baseline|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
11151356|NCT01881126|BG002|Baseline|Total|Total of all reporting groups
11151357|NCT01881126|FG000|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
11151358|NCT01881126|FG001|Participant Flow|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
11151359|NCT01881126|OG000|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
11151360|NCT01881126|OG001|Outcome|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
11151361|NCT01881126|EG000|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
11151362|NCT01881126|EG001|Reported Event|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
11151363|NCT01881230|BG000|Baseline|Arm A: Nab-Paclitaxel Plus (+) Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
11151364|NCT01881230|BG001|Baseline|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
11088795|NCT01520402|FG000|Participant Flow|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.~Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
11088796|NCT01520402|OG000|Outcome|CYP2C9|"The wild-type CYP2C9 allele (*1) was assigned in the absence of other detectable variant alleles. Extensive metabolizers (EMs) were defined as *1/*1 wild-type, intermediate metabolizers (IMs) as *1/variant single variant; and poor metabolizers (PMs) as variant/variant double variant."
11088797|NCT01520402|OG001|Outcome|VKORC1 -1639 G>A|"VKORC1 GG was defined as wild-type; VKORC1 G/A was defined as single variant; and VKORC1 A/A was defined as double variant."
11088798|NCT01520402|OG000|Outcome|CYP4F2 (p.V433M; c.1297G>A)|"CYP4F2 G/G was defined as wild-type, CYP4F2 G/A was defined as single-variant, and CYP4F2 A/A was defined as double-variant"
11088799|NCT01520402|OG000|Outcome|Demographic Only|Demographic variables were gender, age, and race.
11088800|NCT01520402|OG001|Outcome|Demographic Plus CYP2C9|
11088801|NCT01520402|OG002|Outcome|Demographic Plus CYP2C9 and VKORC1|
11088802|NCT01520402|OG003|Outcome|Demographic Plus CYP2C9 and VKORC1 and CYP4F2|
11088803|NCT01520402|OG000|Outcome|CYP2C9/VKORC1 Genotype Group|Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant).
11088804|NCT01520402|EG000|Reported Event|Warfarin|Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin).
11088805|NCT01520454|BG000|Baseline|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088806|NCT01520454|BG001|Baseline|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088807|NCT01520454|BG002|Baseline|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088808|NCT01520454|BG003|Baseline|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
11088809|NCT01520454|BG004|Baseline|Total|Total of all reporting groups
11088810|NCT01520454|FG000|Participant Flow|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
11088811|NCT01520454|FG001|Participant Flow|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088812|NCT01520454|FG002|Participant Flow|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088813|NCT01520454|FG003|Participant Flow|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
11088814|NCT01520454|OG000|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088815|NCT01520454|OG001|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088816|NCT01520454|OG002|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088817|NCT01520454|OG003|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
11088818|NCT01520454|OG000|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
11088819|NCT01520454|OG001|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
11151365|NCT01881230|BG002|Baseline|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
11151366|NCT01881230|BG003|Baseline|Total|Total of all reporting groups
11151367|NCT01881230|FG000|Participant Flow|Arm A: Nab-Paclitaxel Plus (+) Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
11151368|NCT01881230|FG001|Participant Flow|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
11151369|NCT01881230|FG002|Participant Flow|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
11151370|NCT01881230|OG000|Outcome|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment
11151371|NCT01881230|OG001|Outcome|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
11151372|NCT01881230|OG002|Outcome|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
11151373|NCT01881230|EG000|Reported Event|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration in each 21-day treatment cycle.
11151374|NCT01881230|EG001|Reported Event|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by Carboplatin AUC 2 on Days 1 and 8 in each 21-day treatment cycle.
11151375|NCT01881230|EG002|Reported Event|Arm C: Gemcitabine + Carboplatin|Participants received Gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle.
11151376|NCT01881373|BG000|Baseline|CHL Program|"Multiple component environmentally focused intervention designed with a community engagement process.~CHL program: Multiple component environmentally focused program designed with community engagement."
11151377|NCT01881373|BG001|Baseline|Control Community|Control community that participated in community engagement process and received delayed optimized program.
11151378|NCT01881373|BG002|Baseline|Temporal|Control community with limited interaction; for temporal change assessment of anthropometry.
11151379|NCT01881373|BG003|Baseline|Total|Total of all reporting groups
11151380|NCT01881373|FG000|Participant Flow|CHL Program|"Multiple component environmentally focused intervention designed with a community engagement process.~CHL program: Multiple component environmentally focused program designed with community engagement."
11151381|NCT01881373|FG001|Participant Flow|Delayed Optimized CHL Program|Comparison community that participated in community engagement process and received delayed optimized program.
11151382|NCT01881373|FG002|Participant Flow|Temporal|Communities assessed for temporal trends
11151383|NCT01881373|OG000|Outcome|CHL Program|"Multiple component environmentally focused intervention designed with a community engagement process.~CHL program: Multiple component environmentally focused program designed with community engagement."
11151384|NCT01881373|OG001|Outcome|Control Community|Comparison community that participated in community engagement process and will receive delayed optimized program.
11151385|NCT01881373|OG002|Outcome|Temporal|Communities measured for temporal trends
11151386|NCT01881373|OG002|Outcome|Temporal|Communities assessed for temporal trends.
11151387|NCT01881373|OG002|Outcome|Temporal Community|Community assessed for temporal change in anthropometry.
11151388|NCT01881373|OG002|Outcome|Temporal Community|Communities assessed for temporal change in anthropometry.
11151389|NCT01881373|OG002|Outcome|Temporal Community|Communities assessed for temporal changes in anthropometry.
11151390|NCT01881373|EG000|Reported Event|CHL Program|"Multiple component environmentally focused intervention designed with a community engagement process.~CHL program: Multiple component environmentally focused program designed with community engagement."
11151391|NCT01881373|EG001|Reported Event|Delayed Optimized CHL Program|Control community that participated in community engagement process and received delayed optimized program.
11151392|NCT01881373|EG002|Reported Event|Temporal|Communities assessed for temporal trends.
11151393|NCT01881412|BG000|Baseline|Inhaled Corticosteroid (ICS)|"Child receives: 1) asthma discharge instructions, and 2) ICS prescription.~Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.~The family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use."
11151394|NCT01881412|BG001|Baseline|Routine Asthma Care|"Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)~Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated."
11151395|NCT01881412|BG002|Baseline|Total|Total of all reporting groups
11151396|NCT01881412|FG000|Participant Flow|Inhaled Corticosteroid (ICS)|"Child receives: 1) asthma discharge instructions, and 2) ICS prescription.~Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.~The family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use."
11151397|NCT01881412|FG001|Participant Flow|Routine Asthma Care|"Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)~Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated."
11151398|NCT01881412|OG000|Outcome|Inhaled Corticosteroid (Fluticasone)|"Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.~fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).~Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"
11151399|NCT01881412|OG001|Outcome|Routine Asthma Care|"Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)~Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"
11151400|NCT01881412|EG000|Reported Event|Inhaled Corticosteroid (Fluticasone)|"Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.~fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).~Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"
11151401|NCT01881412|EG001|Reported Event|Routine Asthma Care|"Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)~Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"
11151402|NCT01881620|BG000|Baseline|COMBI TEP : PET / Enhanced CT Scan|"COMBI TEP : PET / enhanced CT scan~COMBI TEP : PET / enhanced CT scan: diagnostic imaging exam"
11173799|NCT02017860|OG000|Outcome|Everolimus|Patients who received everolimus in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol and were unable to access everolimus treatment outside of a clinical trial were enrolled.
11151403|NCT01881620|FG000|Participant Flow|COMBI TEP : PET / Enhanced CT Scan|"COMBI TEP : PET / enhanced CT scan : diagnostic imaging exam First, realisation of CT scan without injection followed by a PET scan (TEPSCAN) on the same Phillips GEMINI TF PET/CT camera.~A few minutes after the TEPSCAN, injection CT is performed (XenetiX, iodinated contrast agent 350 mg l/mL).~The COMBI TEP exam includes the TEP and the 2 series of scans (not injected low dose and injected full dose)."
11151404|NCT01881620|OG000|Outcome|COMBI TEP : PET / Enhanced CT Scan|"COMBI TEP : PET / enhanced CT scan~COMBI TEP : PET / enhanced CT scan: diagnostic imaging exam"
11151405|NCT01881620|EG000|Reported Event|COMBI TEP : PET / Enhanced CT Scan|"COMBI TEP : PET / enhanced CT scan~COMBI TEP : PET / enhanced CT scan: diagnostic imaging exam"
11151406|NCT01881737|BG000|Baseline|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
11151407|NCT01881737|FG000|Participant Flow|Pregnenolone|Open-Label Trial
11151408|NCT01881737|OG000|Outcome|Pregnenolone|Open-Label study
11151409|NCT01881737|OG000|Outcome|Pregnenolone|"Pregnenolone up to 500 mg per day~Pregnenolone: With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg~Week 3 and 4: 200 mg~Week 5 and 6: 300 mg~Week 7 and 8: 400 mg~Week 9 -12: 500 mg~At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
11151410|NCT01881737|OG000|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
11151411|NCT01881737|EG000|Reported Event|Pregnenolone|Pregnenolone was not associated with any severe adverse effects. Single episodes of tiredness (n = 1), diarrhea (n = 1), and depressive affect (n = 1) that could possibly be related to pregnenolone were reported. A few other adverse events with remote chance to be related to the medication were reported: increased excitement/agitation (n = 3), sleep problems (n = 1), drowsiness (n = 1), anorexia/decreased appetite (n = 2), increased motor activity (n = 1), sweating (n = 1), constipation (n = 1), diarrhea (n = 1), tremor (n = 1), and depressive affect (n = 1). No significant vital sign or EKG changes occurred in any study participants. No abnormal laboratory tests were caused by pregnenolone.
11151412|NCT01881750|BG000|Baseline|Pivotal Response Training (PRT)|Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
11151413|NCT01881750|BG001|Baseline|Parent Education Group (PEG)|Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
11151414|NCT01881750|BG002|Baseline|Total|Total of all reporting groups
11151415|NCT01881750|FG000|Participant Flow|Pivotal Response Training (PRT)|Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
11151416|NCT01881750|FG001|Participant Flow|Parent Education Group (PEG)|Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
11151417|NCT01881750|OG000|Outcome|Pivotal Response Training (PRT)|"12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.~Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions."
11151418|NCT01881750|OG001|Outcome|Parent Education Group (PEG)|"12 week program consisting of offering/discussion information for parents. No pivotal response training provided.~Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided."
11151419|NCT01881750|OG000|Outcome|Pivotal Response Training (PRT)|Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
11151420|NCT01881750|OG001|Outcome|Parent Education Group (PEG)|Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
11151421|NCT01881750|EG000|Reported Event|Pivotal Response Training (PRT)|Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
11151422|NCT01881750|EG001|Reported Event|Parent Education Group (PEG)|Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
11151423|NCT01881776|BG000|Baseline|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
11173800|NCT02017860|EG000|Reported Event|Everolimus|Patients who received everolimus in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol and were unable to access everolimus treatment outside of a clinical trial were enrolled.
11173801|NCT02017899|BG000|Baseline|S. Sonnei 1790GAHB - 1 mcg|"Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg~S. sonnei 1790GAHB"
11151424|NCT01881776|BG001|Baseline|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
11151425|NCT01881776|BG002|Baseline|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
11151426|NCT01881776|BG003|Baseline|Total|Total of all reporting groups
11151427|NCT01881776|FG000|Participant Flow|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
11151428|NCT01881776|FG001|Participant Flow|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
11151429|NCT01881776|FG002|Participant Flow|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
11151430|NCT01881776|OG000|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
11151431|NCT01881776|OG001|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
11151432|NCT01881776|OG002|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
11151433|NCT01881776|EG000|Reported Event|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
11151434|NCT01881776|EG001|Reported Event|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
11151435|NCT01881776|EG002|Reported Event|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
11151436|NCT01881789|BG000|Baseline|Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151437|NCT01881789|BG001|Baseline|Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11173802|NCT02017899|BG001|Baseline|S. Sonnei 1790GAHB - 5 mcg|"Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg~S. sonnei 1790GAHB"
11173803|NCT02017899|BG002|Baseline|S. Sonnei 1790GAHB - 25 mcg|"Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg~S. sonnei 1790GAHB"
11151438|NCT01881789|BG002|Baseline|Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
11151439|NCT01881789|BG003|Baseline|Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151440|NCT01881789|BG004|Baseline|Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone|"Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151441|NCT01881789|BG005|Baseline|Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first.~After completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment."
11151442|NCT01881789|BG006|Baseline|Total|Total of all reporting groups
11151443|NCT01881789|FG000|Participant Flow|Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151444|NCT01881789|FG001|Participant Flow|Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151445|NCT01881789|FG002|Participant Flow|Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
11151446|NCT01881789|FG003|Participant Flow|Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151447|NCT01881789|FG004|Participant Flow|Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone|"Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151448|NCT01881789|FG005|Participant Flow|Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first.~After completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment."
11151449|NCT01881789|OG000|Outcome|Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151450|NCT01881789|OG001|Outcome|Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151451|NCT01881789|OG002|Outcome|Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151452|NCT01881789|OG003|Outcome|Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151453|NCT01881789|OG004|Outcome|Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone|"Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151454|NCT01881789|OG005|Outcome|Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first.~After completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment."
11151455|NCT01881789|OG002|Outcome|Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
11151456|NCT01881789|EG000|Reported Event|Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151457|NCT01881789|EG001|Reported Event|Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone|"Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151458|NCT01881789|EG002|Reported Event|Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
11151459|NCT01881789|EG003|Reported Event|Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151460|NCT01881789|EG004|Reported Event|Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone|"Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.~After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment."
11151461|NCT01881789|EG005|Reported Event|Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone|"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first.~After completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment."
11151462|NCT01881828|BG000|Baseline|Metformin|"Metformin 2000 mg per day~Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period."
11173804|NCT02017899|BG003|Baseline|S. Sonnei 1790GAHB - 50 mcg|"Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg~S. sonnei 1790GAHB"
11151463|NCT01881828|BG001|Baseline|Oral Placebo|"A central pharmacy will compound a placebo to match the metformin tablets.~The placebo product will contain the following components:~Micosolle™, silica based excipient~Silicified Micro Crystalline Cellulose, National Formulary~Safflower Oil, United States Pharmacopeia~K-30 Povidone Powder~Magnesium Stearate, National Formulary (Vegetable source)~Fumed Silica, National Formulary~oral placebo"
11151464|NCT01881828|BG002|Baseline|Total|Total of all reporting groups
11151465|NCT01881828|FG000|Participant Flow|Metformin|"Metformin 2000 mg per day~Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period."
11151466|NCT01881828|FG001|Participant Flow|Oral Placebo|"A central pharmacy will compound a placebo to match the metformin tablets.~The placebo product will contain the following components:~Micosolle™, silica based excipient~Silicified Micro Crystalline Cellulose, National Formulary~Safflower Oil, United States Pharmacopeia~K-30 Povidone Powder~Magnesium Stearate, National Formulary (Vegetable source)~Fumed Silica, National Formulary~oral placebo"
11151467|NCT01881828|OG000|Outcome|Metformin|"Metformin 2000 mg per day~Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period."
11151468|NCT01881828|OG001|Outcome|Oral Placebo|"A central pharmacy will compound a placebo to match the metformin tablets.~The placebo product will contain the following components:~Micosolle™, silica based excipient~Silicified Micro Crystalline Cellulose, National Formulary~Safflower Oil, United States Pharmacopeia~K-30 Povidone Powder~Magnesium Stearate, National Formulary (Vegetable source)~Fumed Silica, National Formulary~oral placebo"
11151469|NCT01881828|EG000|Reported Event|Metformin|"Metformin 2000 mg per day~Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period."
11151470|NCT01881828|EG001|Reported Event|Oral Placebo|"A central pharmacy will compound a placebo to match the metformin tablets.~The placebo product will contain the following components:~Micosolle™, silica based excipient~Silicified Micro Crystalline Cellulose, National Formulary~Safflower Oil, United States Pharmacopeia~K-30 Povidone Powder~Magnesium Stearate, National Formulary (Vegetable source)~Fumed Silica, National Formulary~oral placebo"
11151471|NCT01881867|BG000|Baseline|Cohort I (no Therapy)|Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy.
11151472|NCT01881867|BG001|Baseline|Cohort II (Glycosylated Recombinant Human Interleukin-7)|"Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~Glycosylated Recombinant Human Interleukin-7: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11151473|NCT01881867|BG002|Baseline|Total|Total of all reporting groups
11151474|NCT01881867|FG000|Participant Flow|Cohort I (no Therapy)|Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
11151475|NCT01881867|FG001|Participant Flow|Cohort II (Glycosylated Recombinant Human Interleukin-7)|"Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.~Glycosylated Recombinant Human Interleukin-7: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11151476|NCT01881867|OG000|Outcome|Cohort I (no Therapy)|Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
11151477|NCT01881867|OG001|Outcome|Cohort II (Glycosylated Recombinant Human Interleukin-7)|"Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.~Glycosylated Recombinant Human Interleukin-7: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11151478|NCT01881867|OG000|Outcome|Cohort I (no Therapy)|Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy.
11151479|NCT01881867|OG001|Outcome|Cohort II (Glycosylated Recombinant Human Interleukin-7)|"Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~Glycosylated Recombinant Human Interleukin-7: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11151480|NCT01881867|EG000|Reported Event|Cohort I (no Therapy)|Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
11151481|NCT01881867|EG001|Reported Event|Cohort II (Glycosylated Recombinant Human Interleukin-7)|"Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.~Glycosylated Recombinant Human Interleukin-7: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11151482|NCT01882062|BG000|Baseline|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
11151483|NCT01882062|FG000|Participant Flow|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
11151484|NCT01882062|OG000|Outcome|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
11151485|NCT01882062|EG000|Reported Event|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
11151486|NCT01882088|BG000|Baseline|Mucofalk|"Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal~Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal"
11151487|NCT01882088|FG000|Participant Flow|Mucofalk|"Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal~Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal"
11151488|NCT01882088|OG000|Outcome|Mucofalk|"Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal~Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal"
11151489|NCT01882088|EG000|Reported Event|Mucofalk|"Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal~Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal"
11151490|NCT01882257|BG000|Baseline|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
11151491|NCT01882257|BG001|Baseline|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
11151492|NCT01882257|BG002|Baseline|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
11151493|NCT01882257|BG003|Baseline|Total|Total of all reporting groups
11151494|NCT01882257|FG000|Participant Flow|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
11151495|NCT01882257|FG001|Participant Flow|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
11151496|NCT01882257|FG002|Participant Flow|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
11151497|NCT01882257|OG000|Outcome|Entire Tested Population|All groups are considered together because this outcome is simply identifying what portion of the defined population (People with Spinal Cord Injury) have which types of sleep disordered breathing
11151498|NCT01882257|OG000|Outcome|Entire Tested Population|All groups are considered together because in determining the efficiency and reliability of home-based overnight testing, there is no difference between the three groups
11151499|NCT01882257|EG000|Reported Event|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
11151500|NCT01882257|EG001|Reported Event|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
11151501|NCT01882257|EG002|Reported Event|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
11151502|NCT01882413|BG000|Baseline|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
11151503|NCT01882413|FG000|Participant Flow|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
11151504|NCT01882413|OG000|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
11151505|NCT01882413|EG000|Reported Event|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
11151506|NCT01882439|BG000|Baseline|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.
11151507|NCT01882439|BG001|Baseline|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets, twice daily.
11151508|NCT01882439|BG002|Baseline|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.
11151509|NCT01882439|BG003|Baseline|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.
11151510|NCT01882439|BG004|Baseline|Total|Total of all reporting groups
11151511|NCT01882439|FG000|Participant Flow|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.
11151512|NCT01882439|FG001|Participant Flow|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets, twice daily.
11151513|NCT01882439|FG002|Participant Flow|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.
11151514|NCT01882439|FG003|Participant Flow|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.
11151515|NCT01882439|OG000|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
11151516|NCT01882439|OG001|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
11151517|NCT01882439|OG002|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
11151518|NCT01882439|OG002|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
11151519|NCT01882439|OG003|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.
11151520|NCT01882439|OG004|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
11151521|NCT01882439|OG002|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily for 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
11151522|NCT01882439|OG003|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
11151523|NCT01882439|OG000|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
11151524|NCT01882439|EG000|Reported Event|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
11151525|NCT01882439|EG001|Reported Event|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
11151526|NCT01882439|EG002|Reported Event|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
11151527|NCT01882439|EG003|Reported Event|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
11151528|NCT01882465|BG000|Baseline|Overall|All subjects that were enrolled into the study.
11151529|NCT01882465|FG000|Participant Flow|Etafilcon A/2-HEMA, EGDMA/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
11151530|NCT01882465|FG001|Participant Flow|Etafilcon A/Hefilcon A/2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
11151531|NCT01882465|FG002|Participant Flow|2-HEMA, EGDMA Non-ionic/Etafilcon A/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
11151532|NCT01882465|FG003|Participant Flow|2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
11151533|NCT01882465|FG004|Participant Flow|Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
11151534|NCT01882465|FG005|Participant Flow|Hefilcon A/Etafilcon A /2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
11151535|NCT01882465|FG006|Participant Flow|Not Assigned|Subjects that signed the inform consent, but them withdrew consent, prior to lens dispensing.
11151536|NCT01882465|OG000|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
11151537|NCT01882465|OG001|Outcome|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
11151538|NCT01882465|OG002|Outcome|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
11151539|NCT01882465|EG000|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
11151540|NCT01882465|EG001|Reported Event|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
11151541|NCT01882465|EG002|Reported Event|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
11151542|NCT01882543|BG000|Baseline|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
11151543|NCT01882543|BG001|Baseline|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
11151544|NCT01882543|BG002|Baseline|Total|Total of all reporting groups
11151545|NCT01882543|FG000|Participant Flow|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
11151546|NCT01882543|FG001|Participant Flow|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
11151547|NCT01882543|OG000|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
11151548|NCT01882543|OG001|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
11151549|NCT01882543|OG000|Outcome|AQX-1125|AQX-1125 Plasma and Urine Concentrations at Week 4 and 6
11151550|NCT01882543|EG000|Reported Event|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
11151551|NCT01882543|EG001|Reported Event|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
11151552|NCT01882647|BG000|Baseline|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
11151553|NCT01882647|BG001|Baseline|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
11151554|NCT01882647|BG002|Baseline|Total|Total of all reporting groups
11151555|NCT01882647|FG000|Participant Flow|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
11151556|NCT01882647|FG001|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
11151557|NCT01882647|OG000|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
11151558|NCT01882647|OG001|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
11151559|NCT01882647|EG000|Reported Event|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
11151560|NCT01882647|EG001|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
11151561|NCT01882725|BG000|Baseline|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11151562|NCT01882725|FG000|Participant Flow|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11151563|NCT01882725|OG000|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11151564|NCT01882725|EG000|Reported Event|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
11151565|NCT01882764|BG000|Baseline|HMPL-004 1800 mg/Day|"Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.~Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.~HMPL-004: Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given HMPL-004 orally three times per day with total daily dose of 1800 mg for 52 weeks."
11151566|NCT01882764|BG001|Baseline|Placebo|"Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.~Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.~Placebo: Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given Placebo orally three times per day with total daily dose of 1800 mg for 52 weeks."
11151567|NCT01882764|BG002|Baseline|Total|Total of all reporting groups
11151568|NCT01882764|FG000|Participant Flow|HMPL-004 1800 mg/Day|"Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.~Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study."
11151569|NCT01882764|FG001|Participant Flow|Placebo|"Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.~Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study."
11151570|NCT01882764|OG000|Outcome|HMPL-004 1800 mg/Day|"Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.~Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study."
11173805|NCT02017899|BG004|Baseline|S. Sonnei 1790GAHB - 100 mcg|"Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg~S. sonnei 1790GAHB"
11151571|NCT01882764|OG001|Outcome|Placebo|"Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.~Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study."
11151572|NCT01882764|EG000|Reported Event|HMPL-004 1800 mg/Day|"Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.~Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study."
11151573|NCT01882764|EG001|Reported Event|Placebo|"Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.~Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study."
11151574|NCT01882803|BG000|Baseline|Duvelisib|Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
11151575|NCT01882803|FG000|Participant Flow|Duvelisib|Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
11151576|NCT01882803|OG000|Outcome|Duvelisib|Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
11151577|NCT01882803|OG001|Outcome|IPI-656|IPI-656 concentration (ng/mL) Full Analysis Set
11151578|NCT01882803|EG000|Reported Event|Duvelisib|Duvelisib: PI3K Inhibitor
11151579|NCT01882829|BG000|Baseline|Nuedexta (Dextromethorphan/Quinidine)|up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
11151580|NCT01882829|FG000|Participant Flow|Nuedexta (Dextromethorphan/Quinidine)|"45/10 mg every 12 hours x 8 weeks~dextromethorphan/quinidine: up to 45/10 mg every 12 hours in patients with TRD with a short 7 day tapering period in which subjects are tapered off 45/10 mg dose from twice a day to once daily for an additional 7 days at post 8-week treatment period to minimize the potential for discontinuation effects"
11151581|NCT01882829|OG000|Outcome|Nuedexta (Dextromethorphan/Quinidine)|up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
11151582|NCT01882829|EG000|Reported Event|Nuedexta (Dextromethorphan/Quinidine)|up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
11151583|NCT01882868|BG000|Baseline|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
11151584|NCT01882868|FG000|Participant Flow|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
11151585|NCT01882868|OG000|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
11151586|NCT01882868|EG000|Reported Event|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
11151587|NCT01882907|BG000|Baseline|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
11151588|NCT01882907|BG001|Baseline|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
11151589|NCT01882907|BG002|Baseline|Total|Total of all reporting groups
11151590|NCT01882907|FG000|Participant Flow|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
11151591|NCT01882907|FG001|Participant Flow|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
11151592|NCT01882907|OG000|Outcome|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
11151593|NCT01882907|OG001|Outcome|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
11151594|NCT01882907|OG000|Outcome|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks~The mean changes in FPG from baseline to week 16 were -20.4 mg/dL The mean changes in PPG levels from baseline to week 16 were -60.2 mg/dL"
11151595|NCT01882907|OG001|Outcome|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks~The mean changes in FPG from baseline to week 16 were -15.0 mg/dL The mean changes in PPG levels from baseline to week 16 were -38.2 mg/dL"
11151596|NCT01882907|EG000|Reported Event|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
11151597|NCT01882907|EG001|Reported Event|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
11151598|NCT01882985|BG000|Baseline|Treatment (Docetaxel and Lycopene)|"Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV~Lycopene: Given PO"
11151599|NCT01882985|FG000|Participant Flow|Treatment (Docetaxel and Lycopene)|"Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV~Lycopene: Given PO"
11151600|NCT01882985|OG000|Outcome|Treatment (Docetaxel and Lycopene)|"Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV~Lycopene: Given PO"
11151601|NCT01882985|EG000|Reported Event|Treatment (Docetaxel and Lycopene)|"Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV~Lycopene: Given PO"
11151602|NCT01883141|BG000|Baseline|Eligible Patients|The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
11151603|NCT01883141|FG000|Participant Flow|Enrolled Patients|Patients who signed informed consent
11151604|NCT01883141|OG000|Outcome|Eligible Patients|The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
11151605|NCT01883141|EG000|Reported Event|Enrolled Patients|Patients who signed informed consent
11151606|NCT01883362|BG000|Baseline|Standard of Care With Midostaurin|Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
11151607|NCT01883362|BG001|Baseline|Standard of Care|Patients received standard of care alone in the post SCT setting
11151608|NCT01883362|BG002|Baseline|Total|Total of all reporting groups
11151609|NCT01883362|FG000|Participant Flow|Standard of Care With Midostaurin|Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
11151610|NCT01883362|FG001|Participant Flow|Standard of Care|Patients received standard of care alone in the post SCT setting
11151611|NCT01883362|OG000|Outcome|Standard of Care With Midostaurin|Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
11151612|NCT01883362|OG001|Outcome|Standard of Care|Patients received standard of care alone in the post SCT setting
11151613|NCT01883362|OG000|Outcome|PKC412|Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
11151614|NCT01883362|OG001|Outcome|Metabolite CGP52421|Metabolite of PKC412 (CGP52421)
11151615|NCT01883362|OG002|Outcome|Metabolite CGP62221|Metabolite of PKC412 (CGP62221)
11151616|NCT01883362|EG000|Reported Event|Standard of Care With Midostaurin|Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
11151617|NCT01883362|EG001|Reported Event|Standard of Care|Patients received standard of care alone in the post SCT setting
11151618|NCT01883362|EG002|Reported Event|ALL Patients|ALL Patients combined
11151619|NCT01883427|BG000|Baseline|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
11151620|NCT01883427|BG001|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
11151621|NCT01883427|BG002|Baseline|Total|Total of all reporting groups
11151622|NCT01883427|FG000|Participant Flow|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
11151623|NCT01883427|FG001|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
11151624|NCT01883427|OG000|Outcome|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
11151625|NCT01883427|OG001|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
11151626|NCT01883427|EG000|Reported Event|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
11151627|NCT01883427|EG001|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
11151628|NCT01883440|BG000|Baseline|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
11151629|NCT01883440|BG001|Baseline|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
11151630|NCT01883440|BG002|Baseline|Total|Total of all reporting groups
11151631|NCT01883440|FG000|Participant Flow|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
11151632|NCT01883440|FG001|Participant Flow|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
11151633|NCT01883440|OG000|Outcome|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
11151634|NCT01883440|OG001|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
11151635|NCT01883440|OG000|Outcome|Saline+Glucose|A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
11151636|NCT01883440|EG000|Reported Event|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
11151637|NCT01883440|EG001|Reported Event|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
11151638|NCT01883453|BG000|Baseline|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
11151639|NCT01883453|BG001|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
11151640|NCT01883453|BG002|Baseline|Total|Total of all reporting groups
11151641|NCT01883453|FG000|Participant Flow|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
11151642|NCT01883453|FG001|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
11151643|NCT01883453|OG000|Outcome|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
11151644|NCT01883453|OG001|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
11151645|NCT01883453|EG000|Reported Event|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
11151646|NCT01883453|EG001|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
11151647|NCT01883492|BG000|Baseline|BIOLOX Delta Head|"Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).~Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.~Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.~Femoral Stem: JMDN classification/Class III device~Acetabular Cup: JMDN classification: Class III device~Acetabular Liner: JMDN classification: Class III device"
11151648|NCT01883492|BG001|Baseline|CoCr Head|"Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).~Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.~CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.~Femoral Stem: JMDN classification/Class III device~Acetabular Cup: JMDN classification: Class III device~Acetabular Liner: JMDN classification: Class III device"
11151649|NCT01883492|BG002|Baseline|Total|Total of all reporting groups
11151650|NCT01883492|FG000|Participant Flow|BIOLOX Delta Head|"Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).~Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.~Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.~Femoral Stem: JMDN classification/Class III device~Acetabular Cup: JMDN classification: Class III device~Acetabular Liner: JMDN classification: Class III device"
11151651|NCT01883492|FG001|Participant Flow|CoCr Head|"Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).~Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.~CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.~Femoral Stem: JMDN classification/Class III device~Acetabular Cup: JMDN classification: Class III device~Acetabular Liner: JMDN classification: Class III device"
11151652|NCT01883492|OG000|Outcome|BIOLOX Delta Head|"Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).~Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.~Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.~Femoral Stem: JMDN classification/Class III device~Acetabular Cup: JMDN classification: Class III device~Acetabular Liner: JMDN classification: Class III device"
11151653|NCT01883492|OG001|Outcome|CoCr Head|"Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).~Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.~CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.~Femoral Stem: JMDN classification/Class III device~Acetabular Cup: JMDN classification: Class III device~Acetabular Liner: JMDN classification: Class III device"
11151654|NCT01883492|EG000|Reported Event|BIOLOX Delta Head|"Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).~Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.~Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.~Femoral Stem: JMDN classification/Class III device~Acetabular Cup: JMDN classification: Class III device~Acetabular Liner: JMDN classification: Class III device"
11151655|NCT01883492|EG001|Reported Event|CoCr Head|"Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).~Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.~CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.~Femoral Stem: JMDN classification/Class III device~Acetabular Cup: JMDN classification: Class III device~Acetabular Liner: JMDN classification: Class III device"
11151656|NCT01883635|BG000|Baseline|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
11151657|NCT01883635|BG001|Baseline|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
11151658|NCT01883635|BG002|Baseline|Total|Total of all reporting groups
11151659|NCT01883635|FG000|Participant Flow|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
11151660|NCT01883635|FG001|Participant Flow|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
11151661|NCT01883635|OG000|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
11151662|NCT01883635|OG001|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
11151663|NCT01883635|EG000|Reported Event|Individual Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
11151664|NCT01883635|EG001|Reported Event|Dyadic Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
11151665|NCT01883635|EG002|Reported Event|Individual Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
11151666|NCT01883635|EG003|Reported Event|Dyadic Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
11151667|NCT01883856|BG000|Baseline|Silicone Plate Ahmed Glaucoma Valve|"Silicone plate Ahmed Glaucoma Valve~Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention."
11151668|NCT01883856|BG001|Baseline|Porous Plate Ahmed Glaucoma Valve|"Porous Plate Ahmed Glaucoma Valve~Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention."
11151669|NCT01883856|BG002|Baseline|Total|Total of all reporting groups
11151670|NCT01883856|FG000|Participant Flow|Silicone Plate Ahmed Glaucoma Valve|"Silicone plate Ahmed Glaucoma Valve~Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention."
11151671|NCT01883856|FG001|Participant Flow|Porous Plate Ahmed Glaucoma Valve|"Porous Plate Ahmed Glaucoma Valve~Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention."
11151672|NCT01883856|OG000|Outcome|Silicone Plate Ahmed Glaucoma Valve|"Silicone plate Ahmed Glaucoma Valve~Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention."
11151673|NCT01883856|OG001|Outcome|Porous Plate Ahmed Glaucoma Valve|"Porous Plate Ahmed Glaucoma Valve~Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention."
11151674|NCT01883856|EG000|Reported Event|Silicone Plate Ahmed Glaucoma Valve|"Silicone plate Ahmed Glaucoma Valve~Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention."
11151675|NCT01883856|EG001|Reported Event|Porous Plate Ahmed Glaucoma Valve|"Porous Plate Ahmed Glaucoma Valve~Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention."
11151676|NCT01883895|BG000|Baseline|Exercise Treatment|"Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,.~Forgioni-Barber pressure-pain stimulator: Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study.~."
11151677|NCT01883895|FG000|Participant Flow|Exercise Treatment|"Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,.~Forgioni-Barber pressure-pain stimulator: Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study.~."
11151678|NCT01883895|OG000|Outcome|Exercise Treatment|"Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise.~Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction.~Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes.~Pain testing conducted Forgionei-Barber pressure pain stimulator"
11151679|NCT01883895|EG000|Reported Event|Exercise Treatment|"Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise.~Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction.~Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes.~Pain testing conducted Forgionei-Barber pressure pain stimulator"
11151680|NCT01883986|BG000|Baseline|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
11151681|NCT01883986|BG001|Baseline|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
11151682|NCT01883986|BG002|Baseline|Total|Total of all reporting groups
11151683|NCT01883986|FG000|Participant Flow|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
11151684|NCT01883986|FG001|Participant Flow|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
11151685|NCT01883986|OG000|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
11151686|NCT01883986|OG001|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
11151687|NCT01883986|EG000|Reported Event|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
11151688|NCT01883986|EG001|Reported Event|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
11151689|NCT01883999|BG000|Baseline|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
11151690|NCT01883999|FG000|Participant Flow|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
11151691|NCT01883999|OG000|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
11151692|NCT01883999|EG000|Reported Event|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
11151693|NCT01884025|BG000|Baseline|Get Moving and Get Well|"Walking class developed for Veterans with serious mental illness and administered as part of the PRRC~Get Moving and Get Well: Walking Class"
11151694|NCT01884025|BG001|Baseline|Health and Humor Class|"Equally engaging attention control condition~Health and Humor Class: Class about the role of humor in health"
11151695|NCT01884025|BG002|Baseline|Total|Total of all reporting groups
11151696|NCT01884025|FG000|Participant Flow|Get Moving and Get Well|"Walking class developed for Veterans with serious mental illness and administered as part of the PRRC~Get Moving and Get Well: Walking Class"
11151697|NCT01884025|FG001|Participant Flow|Health and Humor Class|"Equally engaging attention control condition~Health and Humor Class: Class about the role of humor in health"
11151698|NCT01884025|OG000|Outcome|Get Moving and Get Well|"Walking class developed for Veterans with serious mental illness and administered as part of the PRRC~Get Moving and Get Well: Walking Class"
11151699|NCT01884025|OG001|Outcome|Health and Humor Class|"Equally engaging attention control condition~Health and Humor Class: Class about the role of humor in health"
11151700|NCT01884025|EG000|Reported Event|Get Moving and Get Well|"Walking class developed for Veterans with serious mental illness and administered as part of the PRRC~Get Moving and Get Well: Walking Class"
11151701|NCT01884025|EG001|Reported Event|Health and Humor Class|"Equally engaging attention control condition~Health and Humor Class: Class about the role of humor in health"
11151702|NCT01884064|BG000|Baseline|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
11151703|NCT01884064|BG001|Baseline|Sham rTMS|"Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~Sham rTMS: Sham rTMS"
11151704|NCT01884064|BG002|Baseline|Total|Total of all reporting groups
11151705|NCT01884064|FG000|Participant Flow|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
11151706|NCT01884064|FG001|Participant Flow|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
11151707|NCT01884064|OG000|Outcome|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
11151708|NCT01884064|OG001|Outcome|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
11151709|NCT01884064|EG000|Reported Event|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
11151710|NCT01884064|EG001|Reported Event|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
11151711|NCT01884311|BG000|Baseline|Subgam-VF|Subgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion over a period of 26 weeks.
11151712|NCT01884311|FG000|Participant Flow|Subgam-VF|Subgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion over a period of 26 weeks.
11151713|NCT01884311|OG000|Outcome|Subgam-VF and Gammaplex 5%|"Subgam-VF~Subgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion. The total duration of treatment will be for 26 weeks.~The initial weekly dose of Subgam-VF administered will be calculated by taking the average weekly equivalent of the subject's IGIV dose (should be stable, as in same mg/kg +/- 5%), divided by the average dosing interval in weeks (i.e. 3 or 4), multiplied by 1.37, a dose adjustment coefficient based on other licensed subcutaneous IgG products. If the subject was already receiving a weekly SCIG IgG there will be no dose adjustment.~This population included 50 Subjects from GMX01 (NCT00278954), 25 Subjects from GMX04 (NCT01289847) and 38 Subjects from SCIG03."
11151714|NCT01884311|OG000|Outcome|Subgam-VF|Subgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion for a total duration of 26 weeks.
11151715|NCT01884311|OG000|Outcome|Subgam-VF and Gammaplex 5%|"Subgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion for a total duration of 26 weeks.~This population included 23 Subjects from the Gammaplex PK Populations in GMX01 (NCT00278954) and 21 Subjects from GMX04 (NCT01289847), in addition included 20 Subjects from SCIG03."
11151716|NCT01884311|OG000|Outcome|Subgam-VF|"Subgam-VF~Subgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion. The total duration of treatment will be for 26 weeks.~The initial weekly dose of Subgam-VF administered will be calculated by taking the average weekly equivalent of the subject's IGIV dose (should be stable, as in same mg/kg +/- 5%), divided by the average dosing interval in weeks (i.e. 3 or 4), multiplied by 1.37, a dose adjustment coefficient based on other licensed subcutaneous IgG products. If the subject was already receiving a weekly SCIG IgG there will be no dose adjustment."
11151717|NCT01884311|EG000|Reported Event|Subgam-VF|Subgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion for a total duration of 26 weeks.
11173806|NCT02017899|BG005|Baseline|Placebo|"2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses~Placebo"
11173807|NCT02017899|BG006|Baseline|Total|Total of all reporting groups
11173808|NCT02017899|FG000|Participant Flow|S. Sonnei 1790GAHB - 1 mcg|"Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg~S. sonnei 1790GAHB"
11173809|NCT02017899|FG001|Participant Flow|S. Sonnei 1790GAHB - 5 mcg|"Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg~S. sonnei 1790GAHB"
11173810|NCT02017899|FG002|Participant Flow|S. Sonnei 1790GAHB - 25 mcg|"Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg~S. sonnei 1790GAHB"
11151718|NCT01884337|BG000|Baseline|Total Knee Replacement (TKR)|Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks
11151719|NCT01884337|BG001|Baseline|Total Hip Replacement (THR)|Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
11151720|NCT01884337|BG002|Baseline|Total|Total of all reporting groups
11151721|NCT01884337|FG000|Participant Flow|Total Knee Replacement (TKR)|Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks
11151722|NCT01884337|FG001|Participant Flow|Total Hip Replacement (THR)|Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
11151723|NCT01884337|OG000|Outcome|Total Knee Replacement (TKR)|Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks
11151724|NCT01884337|OG001|Outcome|Total Hip Replacement (THR)|Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
11151725|NCT01884337|EG000|Reported Event|TOTAL KNEE REPLACEMENT (TKR)|Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks
11151726|NCT01884337|EG001|Reported Event|TOTAL HIP REPLACEMENT (THR)|Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
11151727|NCT01884350|BG000|Baseline|Apixaban (Primary SOC Information)|Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.
11151728|NCT01884350|BG001|Baseline|Apixaban (Additional Educational Program)|Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.
11151729|NCT01884350|BG002|Baseline|Total|Total of all reporting groups
11151730|NCT01884350|FG000|Participant Flow|Apixaban (Primary SOC)|Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.
11151731|NCT01884350|FG001|Participant Flow|Apixaban (Additional Educational Program)|Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.
11151732|NCT01884350|FG002|Participant Flow|Apixaban (Secondary SOC)|Participants were originally in the Apixaban (AEP) arm and treated with Apixaban 2.5 mg or 5 mg by mouth twice daily and Additional Educational Program (AEP) for the first 24 weeks. After the initial 24-week primary endpoint period participants stopped receiving AEP and were transferred from Apixaban (AEP) arm, stopped the Additional Educational Program (AEP), and switched to the Standard of Care (SOC) information for an additional 24 weeks.
11151733|NCT01884350|OG000|Outcome|Apixaban (Primary SOC Information)|Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.
11151734|NCT01884350|OG001|Outcome|Apixaban (Additional Educational Program)|Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.
11151735|NCT01884350|OG002|Outcome|Apixaban (Secondary SOC)|Participants were originally in the Apixaban (AEP) arm and treated with Apixaban 2.5 mg or 5 mg by mouth twice daily and Additional Educational Program (AEP) for the first 24 weeks. After the initial 24-week primary endpoint period participants stopped receiving AEP and were transferred from Apixaban (AEP) arm, stopped the Additional Educational Program (AEP), and switched to the Standard of Care (SOC) information for an additional 24 weeks.
11151736|NCT01884350|EG000|Reported Event|Primary SOC (Period 1)|Apixaban 2.5 mg or 5 mg by mouth twice daily for 24 weeks and Primary SOC information.
11151737|NCT01884350|EG001|Reported Event|Continued Additional Educational Program (CAEP) (Period 2)|Subjects enrolled in AEP program during the first 24 weeks continued receiving AEP program up to 48 weeks.
11151738|NCT01884350|EG002|Reported Event|Secondary SOC (Period 2)|Subjects who received AEP for 24 weeks then revert to SOC after the second randomization.
11151739|NCT01884350|EG003|Reported Event|Additional Educational Program (Period 1)|Apixaban 2.5 mg or 5 mg by mouth twice daily for 24 weeks and Additional Educational Program.
11151740|NCT01884350|EG004|Reported Event|Primary SOC (Period 2)|Subjects who received Apixaban 2.5 mg or 5 mg by mouth twice daily for initial 24 weeks and Primary SOC information continued for a period 48 Weeks.
11151741|NCT01884519|BG000|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151742|NCT01884519|BG001|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151743|NCT01884519|BG002|Baseline|Total|Total of all reporting groups
11151744|NCT01884519|FG000|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151745|NCT01884519|FG001|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151746|NCT01884519|OG000|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151747|NCT01884519|OG001|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151748|NCT01884519|OG001|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
10887677|NCT00502307|OG000|Outcome|Open-label Period: Tivozanib (AV-951)|Subjects were enrolled into the initial, 16-week, open-label period and received tivozanib at a dose of 1.5 mg/day (oral administration). Subjects received tivozanib continuously for 3 weeks followed by 1 week off study drug (1 cycle = 3 weeks on, 1 week off).
11151749|NCT01884519|OG000|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151750|NCT01884519|OG001|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151751|NCT01884519|OG002|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151752|NCT01884519|OG003|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151753|NCT01884519|OG000|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151754|NCT01884519|OG001|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151755|NCT01884519|OG002|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccinationars Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151756|NCT01884519|EG000|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151757|NCT01884519|EG001|Reported Event|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
11151758|NCT01884545|BG000|Baseline|Standard Risk Assessment (SRA)|"Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151759|NCT01884545|BG001|Baseline|SRA Plus Health Coaching (HC)|"In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151760|NCT01884545|BG002|Baseline|SRA Plus Genetic Risk Counseling (GRC)|"In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151761|NCT01884545|BG003|Baseline|SRA+HC+GRC|"In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151762|NCT01884545|BG004|Baseline|Total|Total of all reporting groups
11151763|NCT01884545|FG000|Participant Flow|Standard Risk Assessment (SRA)|"Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151764|NCT01884545|FG001|Participant Flow|SRA Plus Health Coaching (HC)|"In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11173811|NCT02017899|FG003|Participant Flow|S. Sonnei 1790GAHB - 50 mcg|"Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg~S. sonnei 1790GAHB"
11228064|NCT02388165|OG001|Outcome|Placebo|Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
11088820|NCT01520454|OG002|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
11088821|NCT01520454|EG000|Reported Event|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088822|NCT01520454|EG001|Reported Event|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088823|NCT01520454|EG002|Reported Event|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
11088824|NCT01520454|EG003|Reported Event|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
11088825|NCT01520506|BG000|Baseline|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
11088826|NCT01520506|FG000|Participant Flow|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. Radiofrequency (RF) is applied with pre-programmed time and intensity in each of the renal arteries.
11088827|NCT01520506|OG000|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
11088828|NCT01520506|EG000|Reported Event|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
11088829|NCT01520519|BG000|Baseline|Rituximab + PCI-32765|"Rituximab (375 mg/m2) given intravenously (IV) on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6. PCI-32765 started on Day 2 of cycle 1 at a dose of 420 mg (3 * 140-mg capsules) orally daily and will be continued daily.~Rituximab: 375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.~PCI-32765: 420 mg (3 * 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily."
11088830|NCT01520519|FG000|Participant Flow|Rituximab + PCI-32765|"Rituximab (375 mg/m2) given intravenously (IV) on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6. PCI-32765 started on Day 2 of cycle 1 at a dose of 420 mg (3 * 140-mg capsules) orally daily and will be continued daily.~Rituximab: 375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.~PCI-32765: 420 mg (3 * 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily."
11088831|NCT01520519|OG000|Outcome|Rituximab + PCI-32765|"Rituximab (375 mg/m2) given intravenously (IV) on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6. PCI-32765 started on Day 2 of cycle 1 at a dose of 420 mg (3 * 140-mg capsules) orally daily and will be continued daily.~Rituximab: 375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.~PCI-32765: 420 mg (3 * 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily."
11088832|NCT01520519|EG000|Reported Event|Rituximab + PCI-32765|"Rituximab (375 mg/m2) given intravenously (IV) on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6. PCI-32765 started on Day 2 of cycle 1 at a dose of 420 mg (3 * 140-mg capsules) orally daily and will be continued daily.~Rituximab: 375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.~PCI-32765: 420 mg (3 * 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily."
11088833|NCT01520532|BG000|Baseline|Ablation|
11088834|NCT01520532|FG000|Participant Flow|Ablation|Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).
11088835|NCT01520532|OG000|Outcome|Ablation|
11088836|NCT01520532|EG000|Reported Event|Ablation|
11088837|NCT01520558|BG000|Baseline|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088838|NCT01520558|BG001|Baseline|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088839|NCT01520558|BG002|Baseline|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088840|NCT01520558|BG003|Baseline|Total|Total of all reporting groups
11151765|NCT01884545|FG002|Participant Flow|SRA Plus Genetic Risk Counseling (GRC)|"In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151766|NCT01884545|FG003|Participant Flow|SRA+HC+GRC|"In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151767|NCT01884545|OG000|Outcome|Health Coaching|Participants who received health coaching
11151768|NCT01884545|OG001|Outcome|Non-Health Coaching|Participants who did not receive health coaching
11151769|NCT01884545|OG002|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
11151770|NCT01884545|OG003|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
11151771|NCT01884545|EG000|Reported Event|Standard Risk Assessment (SRA)|"Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151772|NCT01884545|EG001|Reported Event|SRA Plus Health Coaching (HC)|"In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151773|NCT01884545|EG002|Reported Event|SRA Plus Genetic Risk Counseling (GRC)|"In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151774|NCT01884545|EG003|Reported Event|SRA+HC+GRC|"In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
11151775|NCT01884571|BG000|Baseline|Immunosuppression Regimen|All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
11151776|NCT01884571|FG000|Participant Flow|Immunosuppression Regimen|"All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment (described below) and the treatment period lasted for six months.~Basiliximab: 20 mg, IV (in the vein) on day 1 and 4.~Methylprednisolone: 125 mg, IV (in the vein) on day 1.~Prednisone: 60 mg PO (by mouth) on days 2-7, 40 mg PO days 8-14, 20 mg PO days 15-21, and 10mg PO days 22-28.~Tacrolimus: 1-5 mg PO, twice a day (BID) days 2-180.~Mycophenolate mofetil: 500 mg PO, BID days 2-7, 500 mg PO each morning and 1000 mg each night, days 8-14, 1000 mg PO BID days 15-180."
11151777|NCT01884571|OG000|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
11151778|NCT01884571|EG000|Reported Event|Immunosuppression Regimen|All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
11151779|NCT01884597|BG000|Baseline|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151780|NCT01884597|BG001|Baseline|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151781|NCT01884597|BG002|Baseline|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151782|NCT01884597|BG003|Baseline|Total|Total of all reporting groups
11151783|NCT01884597|FG000|Participant Flow|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151784|NCT01884597|FG001|Participant Flow|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151785|NCT01884597|FG002|Participant Flow|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151786|NCT01884597|OG000|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151787|NCT01884597|OG001|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151788|NCT01884597|OG002|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151789|NCT01884597|OG000|Outcome|Cohort 1|No ocular adverse events
11151790|NCT01884597|OG001|Outcome|Cohort 2|No ocular adverse events
11151791|NCT01884597|OG002|Outcome|Cohort 3|No ocular adverse events
11151792|NCT01884597|OG000|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151793|NCT01884597|OG001|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
10851393|NCT00306202|OG003|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
11151794|NCT01884597|OG002|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151795|NCT01884597|EG000|Reported Event|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151796|NCT01884597|EG001|Reported Event|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151797|NCT01884597|EG002|Reported Event|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
11151798|NCT01884675|BG000|Baseline|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
11151799|NCT01884675|BG001|Baseline|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
11151800|NCT01884675|BG002|Baseline|Total|Total of all reporting groups
11151801|NCT01884675|FG000|Participant Flow|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
11151802|NCT01884675|FG001|Participant Flow|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
11151803|NCT01884675|OG000|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
11151804|NCT01884675|OG001|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
11151805|NCT01884675|OG001|Outcome|Ambrisentan 5mg|Subjects in this arm will receive ambrisentan-matching placebo tablet once daily during the treatment period.
11151806|NCT01884675|OG000|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.c
11151807|NCT01884675|EG000|Reported Event|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
11151808|NCT01884675|EG001|Reported Event|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
11151809|NCT01884688|BG000|Baseline|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
11151810|NCT01884688|FG000|Participant Flow|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
11151811|NCT01884688|OG000|Outcome|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
11151812|NCT01884688|EG000|Reported Event|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
11151813|NCT01884844|BG000|Baseline|Vitamin D3|"Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks~Vitamin D3, Cholecalciferol"
11151814|NCT01884844|BG001|Baseline|Placebo|"methylcellulose po qday for 12weeks~Placebo"
11151815|NCT01884844|BG002|Baseline|Total|Total of all reporting groups
11151816|NCT01884844|FG000|Participant Flow|Vitamin D3|"Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks~Vitamin D3, Cholecalciferol"
11151817|NCT01884844|FG001|Participant Flow|Placebo|"methylcellulose po qday for 12weeks~Placebo"
11151818|NCT01884844|OG000|Outcome|Vitamin D3|"Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks~Vitamin D3, Cholecalciferol"
11151819|NCT01884844|OG001|Outcome|Placebo|"methylcellulose po qday for 12weeks~Placebo"
11151820|NCT01884844|EG000|Reported Event|Vitamin D3|"Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks~Vitamin D3, Cholecalciferol"
11151821|NCT01884844|EG001|Reported Event|Placebo|"methylcellulose po qday for 12weeks~Placebo"
11151822|NCT01885000|BG000|Baseline|Brimonidine Tartrate 0.5% Gel|Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
11151823|NCT01885000|BG001|Baseline|Vehicle|Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
11151824|NCT01885000|BG002|Baseline|Total|Total of all reporting groups
11151825|NCT01885000|FG000|Participant Flow|Brimonidine Tartrate 0.5% Gel|Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
11151826|NCT01885000|FG001|Participant Flow|Vehicle|Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
11151827|NCT01885000|OG000|Outcome|Brimonidine Tartrate 0.5% Gel|Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
11151828|NCT01885000|OG001|Outcome|Vehicle|Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
11151829|NCT01885000|EG000|Reported Event|Brimonidine Tartrate 0.5% Gel|Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
11151830|NCT01885000|EG001|Reported Event|Vehicle|Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
11151831|NCT01885104|BG000|Baseline|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
11151832|NCT01885104|BG001|Baseline|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
11151833|NCT01885104|BG002|Baseline|Total|Total of all reporting groups
11151834|NCT01885104|FG000|Participant Flow|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
11151835|NCT01885104|FG001|Participant Flow|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
11151836|NCT01885104|OG000|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
11151837|NCT01885104|OG001|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
11151838|NCT01885104|EG000|Reported Event|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
11151839|NCT01885104|EG001|Reported Event|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
11151840|NCT01885117|BG000|Baseline|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
11151841|NCT01885117|BG001|Baseline|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
11151842|NCT01885117|BG002|Baseline|Total|Total of all reporting groups
11151843|NCT01885117|FG000|Participant Flow|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
11151844|NCT01885117|FG001|Participant Flow|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
11151845|NCT01885117|OG000|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
11151846|NCT01885117|OG001|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
11151847|NCT01885117|EG000|Reported Event|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
11088841|NCT01520558|FG000|Participant Flow|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088842|NCT01520558|FG001|Participant Flow|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088843|NCT01520558|FG002|Participant Flow|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088844|NCT01520558|OG000|Outcome|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088845|NCT01520558|OG001|Outcome|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088846|NCT01520558|OG002|Outcome|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088847|NCT01520558|EG000|Reported Event|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088848|NCT01520558|EG001|Reported Event|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088849|NCT01520558|EG002|Reported Event|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
11088850|NCT01520688|BG000|Baseline|All Study Participants|
11088851|NCT01520688|FG000|Participant Flow|1 Treatment Sequence, FPQ|"Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR~Fluticasone, Budesonide, Beclomethasone: Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid"
11088852|NCT01520688|FG001|Participant Flow|2 Treatment Sequence, FQP|"Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort~Fluticasone, Beclomethasone, Budesonide: Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID"
11088853|NCT01520688|FG002|Participant Flow|3 Treatment Sequence, PFQ|"Period 2 Pulmicort Period 4 Flovent Period 6 QVAR~Budesonide, Fluticasone, Beclomethasone: Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID"
11088854|NCT01520688|FG003|Participant Flow|4-Treatment Sequence, PQF|"Period 2 Pulmicort Period 4 QVAR Period 6 Flovent~Budesonide, Beclomethasone, Fluticasone: Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID"
11088855|NCT01520688|FG004|Participant Flow|5 Treatment Sequence, QFP|"Period 2 QVAR Period 4 Flovent Period 6 Pulmicort~Beclomethasone, Fluticasone, Budesonide: Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID"
11088856|NCT01520688|FG005|Participant Flow|6 Treatment Sequence, QPF|"Period 2 QVAR Period 4 Pulmicort Period 6 Flovent~Beclomethasone, Budesonide, Fluticasone: Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID"
11088857|NCT01520688|FG006|Participant Flow|Enrolled But Not Randomized.|These subjects were consented but not randomized.
11088858|NCT01520688|OG000|Outcome|Flovent Discus 100 mcg BID|
11088859|NCT01520688|OG001|Outcome|Pulmicort Flexhaler 180 mcg BID|
11088860|NCT01520688|OG001|Outcome|QVAR 80 mcg BID|
11088861|NCT01520688|EG000|Reported Event|Flovent Discus 100 mcg BID|
11088862|NCT01520688|EG001|Reported Event|Pulmicort Flexhaler 180 mcg BID|
11088863|NCT01520688|EG002|Reported Event|QVAR 80 mcg BID|
11088864|NCT01520727|BG000|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088865|NCT01520727|BG001|Baseline|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088866|NCT01520727|BG002|Baseline|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088867|NCT01520727|BG003|Baseline|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088868|NCT01520727|BG004|Baseline|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088869|NCT01520727|BG005|Baseline|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088870|NCT01520727|BG006|Baseline|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088871|NCT01520727|BG007|Baseline|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088872|NCT01520727|BG008|Baseline|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
11088873|NCT01520727|BG009|Baseline|Total|Total of all reporting groups
11088874|NCT01520727|FG000|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088875|NCT01520727|FG001|Participant Flow|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088876|NCT01520727|FG002|Participant Flow|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088877|NCT01520727|FG003|Participant Flow|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088878|NCT01520727|FG004|Participant Flow|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088879|NCT01520727|FG005|Participant Flow|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088880|NCT01520727|FG006|Participant Flow|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088881|NCT01520727|FG007|Participant Flow|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088882|NCT01520727|FG008|Participant Flow|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
11088883|NCT01520727|OG000|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088884|NCT01520727|OG001|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088885|NCT01520727|OG002|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088886|NCT01520727|OG003|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088887|NCT01520727|OG004|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088888|NCT01520727|OG005|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088889|NCT01520727|OG006|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088890|NCT01520727|OG007|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088891|NCT01520727|OG008|Outcome|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
11088892|NCT01520727|EG000|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088893|NCT01520727|EG001|Reported Event|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088894|NCT01520727|EG002|Reported Event|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088895|NCT01520727|EG003|Reported Event|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088896|NCT01520727|EG004|Reported Event|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088897|NCT01520727|EG005|Reported Event|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088898|NCT01520727|EG006|Reported Event|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088899|NCT01520727|EG007|Reported Event|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
11088900|NCT01520727|EG008|Reported Event|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
11088901|NCT01520870|BG000|Baseline|PF-299804 (Dacomitinib)|"Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end. Patients at first recurrence will be enrolled onto 1 of 2 cohorts that will be recruited and analysed independently. Cohort A will include patients who have EGFRvIII mutations. Cohort B will include patients who have EGFR gene amplification but no EGFRvIII mutations.~PF-299804 (Dacomitinib): Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end."
11088902|NCT01520870|FG000|Participant Flow|PF-299804 (Dacomitinib)|"Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end. Patients at first recurrence will be enrolled onto 1 of 2 cohorts that will be recruited and analysed independently. Cohort A will include patients who have EGFRvIII mutations. Cohort B will include patients who have EGFR gene amplification but no EGFRvIII mutations.~PF-299804 (Dacomitinib): Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end."
11088903|NCT01520870|OG000|Outcome|PF-299804 (Dacomitinib)|"Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end. Patients at first recurrence will be enrolled onto 1 of 2 cohorts that will be recruited and analysed independently. Cohort A will include patients who have EGFRvIII mutations. Cohort B will include patients who have EGFR gene amplification but no EGFRvIII mutations.~PF-299804 (Dacomitinib): Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end."
11151848|NCT01885117|EG001|Reported Event|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
11151849|NCT01885182|BG000|Baseline|Oxycodone/Naloxone|"5/2.5mg, 10/5mg, 20/10mg or 40/20mg~Oxycodone/Naloxone"
11151850|NCT01885182|BG001|Baseline|Oxycodone|"5mg, 10mg, 20mg or 40mg~Oxycodone"
11151851|NCT01885182|BG002|Baseline|Total|Total of all reporting groups
11151852|NCT01885182|FG000|Participant Flow|Oxycodone/Naloxone|"5/2.5mg, 10/5mg, 20/10mg or 40/20mg~Oxycodone/Naloxone"
11151853|NCT01885182|FG001|Participant Flow|Oxycodone|"5mg, 10mg, 20mg or 40mg~Oxycodone"
11151854|NCT01885182|OG000|Outcome|Oxycodone/Naloxone|"5/2.5mg, 10/5mg, 20/10mg or 40/20mg~Oxycodone/Naloxone"
11151855|NCT01885182|OG001|Outcome|Oxycodone|"5mg, 10mg, 20mg or 40mg~Oxycodone"
11151856|NCT01885182|OG000|Outcome|Oxycodone/Naloxone|5/2.5mg, 10/5mg, 20/10mg or 40/20mg
11151857|NCT01885182|OG001|Outcome|Oxycodone|5mg, 10mg, 20mg or 40mg
11151858|NCT01885182|EG000|Reported Event|Oxycodone/Naloxone|"5/2.5mg, 10/5mg, 20/10mg or 40/20mg~Oxycodone/Naloxone"
11151859|NCT01885182|EG001|Reported Event|Oxycodone|"5mg, 10mg, 20mg or 40mg~Oxycodone"
11151860|NCT01885195|BG000|Baseline|Binimetinib (MEK162)|Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
11151861|NCT01885195|FG000|Participant Flow|Binimetinib (MEK162)|Participants received an oral dose of 45 milligram (mg) of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
11151862|NCT01885195|OG000|Outcome|Binimetinib (MEK162)|Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
11151863|NCT01885195|EG000|Reported Event|Binimetinib (MEK162)|Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
11151864|NCT01885208|BG000|Baseline|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
11151865|NCT01885208|BG001|Baseline|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
11151866|NCT01885208|BG002|Baseline|Total|Total of all reporting groups
11151867|NCT01885208|FG000|Participant Flow|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
11151868|NCT01885208|FG001|Participant Flow|Exenatide ER 2.0 mg|Subjects on exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
11151869|NCT01885208|OG000|Outcome|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
11151870|NCT01885208|OG001|Outcome|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
11173812|NCT02017899|FG004|Participant Flow|S. Sonnei 1790GAHB - 100 mcg|"Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg~S. sonnei 1790GAHB"
11173813|NCT02017899|FG005|Participant Flow|Placebo|"2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses~Placebo"
11151871|NCT01885208|EG000|Reported Event|Sema 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD)therapy throughout the trial, unless rescue medication was needed.
11151872|NCT01885208|EG001|Reported Event|Exenatide ER|Subjects randomised to exenatide extended release (ER) 2.0 mg(Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
11151873|NCT01885559|BG000|Baseline|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
11151874|NCT01885559|BG001|Baseline|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
11151875|NCT01885559|BG002|Baseline|Total|Total of all reporting groups
11151876|NCT01885559|FG000|Participant Flow|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
11151877|NCT01885559|FG001|Participant Flow|ACE-I + Angiotensin Receptor Blocker (ARB)|"ACE-I + angiotensin receptor blocker (ARB) and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
11151878|NCT01885559|OG000|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
11151879|NCT01885559|OG001|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
11151880|NCT01885559|EG000|Reported Event|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
11151881|NCT01885559|EG001|Reported Event|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
11151882|NCT01885871|BG000|Baseline|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
11151883|NCT01885871|FG000|Participant Flow|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
11151884|NCT01885871|OG000|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
11151885|NCT01885871|EG000|Reported Event|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
11151886|NCT01885897|BG000|Baseline|ALT-803, IV, 1 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151887|NCT01885897|BG001|Baseline|ALT-803, IV, 3 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151888|NCT01885897|BG002|Baseline|ALT-803, IV, 6 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151889|NCT01885897|BG003|Baseline|ALT-803, IV, 10 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151890|NCT01885897|BG004|Baseline|ALT-803, SQ, 6 mcg/kg|Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
11151891|NCT01885897|BG005|Baseline|ALT-803, SQ, 10 mcg/kg|Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
11151892|NCT01885897|BG006|Baseline|Total|Total of all reporting groups
11151893|NCT01885897|FG000|Participant Flow|ALT-803, IV, 1 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151894|NCT01885897|FG001|Participant Flow|ALT-803, IV, 3 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151895|NCT01885897|FG002|Participant Flow|ALT-803, IV, 6 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151896|NCT01885897|FG003|Participant Flow|ALT-803, IV, 10 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151897|NCT01885897|FG004|Participant Flow|ALT-803, SQ, 6 mcg/kg|Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
11151898|NCT01885897|FG005|Participant Flow|ALT-803, SQ, 10 mcg/kg|Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
11151899|NCT01885897|OG000|Outcome|ALT-803, IV, 1 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151900|NCT01885897|OG001|Outcome|ALT-803, IV, 3 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151901|NCT01885897|OG002|Outcome|ALT-803, IV, 6 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151902|NCT01885897|OG003|Outcome|ALT-803, IV, 10 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151903|NCT01885897|OG004|Outcome|ALT-803, SQ, 6 mcg/kg|Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
11151904|NCT01885897|OG005|Outcome|ALT-803, SQ, 10 mcg/kg|Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
11151905|NCT01885897|EG000|Reported Event|ALT-803, IV, 1 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151906|NCT01885897|EG001|Reported Event|ALT-803, IV, 3 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151907|NCT01885897|EG002|Reported Event|ALT-803, IV, 6 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151908|NCT01885897|EG003|Reported Event|ALT-803, IV, 10 mcg/kg|Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
11151909|NCT01885897|EG004|Reported Event|ALT-803, SQ, 6 mcg/kg|Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
11151910|NCT01885897|EG005|Reported Event|ALT-803, SQ, 10 mcg/kg|Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
11151911|NCT01885910|BG000|Baseline|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
11151912|NCT01885910|FG000|Participant Flow|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily~Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
11151913|NCT01885910|OG000|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
11151914|NCT01885910|OG000|Outcome|Aczone/Doxy - Inflammatory|inflammatory lesion counts during treatment with aczone 5% and doxycycline 100mg
11151915|NCT01885910|OG001|Outcome|Aczone/Doxy - Non Inflammatory|non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
11151916|NCT01885910|EG000|Reported Event|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily~Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
11151917|NCT01885936|BG000|Baseline|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
11151918|NCT01885936|BG001|Baseline|Placebo Comparator|Placebo administered
11151919|NCT01885936|BG002|Baseline|Total|Total of all reporting groups
11151920|NCT01885936|FG000|Participant Flow|Albuterol|Initially 4 mg daily for one week, 4 mg BID (twice a day) per oral for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
11151921|NCT01885936|FG001|Participant Flow|Placebo Comparator|Placebo administered
11151922|NCT01885936|OG000|Outcome|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
11151923|NCT01885936|OG001|Outcome|Placebo Comparator|Placebo administered
11151924|NCT01885936|EG000|Reported Event|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
11151925|NCT01885936|EG001|Reported Event|Placebo Comparator|Placebo administered
11151926|NCT01886105|BG000|Baseline|SmEDTMP/Autologous Stem Cell Infusion/RT|Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
11151927|NCT01886105|FG000|Participant Flow|SmEDTMP/Autologous Stem Cell Infusion/RT|Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy to be delivered according to the judgement of the treating radiation oncologist.
11151928|NCT01886105|OG000|Outcome|SmEDTMP/Autologous Stem Cell Infusion/RT|Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
11151929|NCT01886105|OG000|Outcome|SmEDTMP/Autologous Stem Cell Infusion/RT|"Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.~External Beam Radiotherapy: The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning."
11088904|NCT01520870|EG000|Reported Event|PF-299804 (Dacomitinib)|"Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end. Patients at first recurrence will be enrolled onto 1 of 2 cohorts that will be recruited and analysed independently. Cohort A will include patients who have EGFRvIII mutations. Cohort B will include patients who have EGFR gene amplification but no EGFRvIII mutations.~PF-299804 (Dacomitinib): Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end."
11088905|NCT01520909|BG000|Baseline|Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day. In Part 2, participants received eltrombopag. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
11088906|NCT01520909|BG001|Baseline|Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines.
11088907|NCT01520909|BG002|Baseline|Total|Total of all reporting groups
11088908|NCT01520909|FG000|Participant Flow|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day). Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
11088909|NCT01520909|FG001|Participant Flow|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
11088910|NCT01520909|FG002|Participant Flow|Part 2 (Open-Label Period) Eltrombopag|All participants receiving placebo in Part 1 received eltrombopag in Part 2 following starting dose guidelines for Part 1. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants receiving eltrombopag in Part 1 continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
11088911|NCT01520909|OG000|Outcome|Part 1 (Randomized Period)- Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day).
11088912|NCT01520909|OG001|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
11088913|NCT01520909|OG000|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
11088914|NCT01520909|OG001|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
11088915|NCT01520909|OG001|Outcome|Part 1 (Randomized Period) -Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
11173814|NCT02017899|OG000|Outcome|S. Sonnei 1790GAHB - 1 mcg|"Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg~S. sonnei 1790GAHB"
11173815|NCT02017899|OG001|Outcome|S. Sonnei 1790GAHB - 5 mcg|"Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg~S. sonnei 1790GAHB"
11151930|NCT01886105|EG000|Reported Event|SmEDTMP/Autologous Stem Cell Infusion/RT|Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
11151931|NCT01886235|BG000|Baseline|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11151932|NCT01886235|FG000|Participant Flow|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11151933|NCT01886235|OG000|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11151934|NCT01886235|EG000|Reported Event|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11151935|NCT01886287|BG000|Baseline|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
11151936|NCT01886287|FG000|Participant Flow|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
11151937|NCT01886287|OG000|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
11151938|NCT01886287|EG000|Reported Event|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
11151939|NCT01886300|BG000|Baseline|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
11151940|NCT01886300|FG000|Participant Flow|Peginterferon Alfa-2a|Participants with hepatitis B envelope antigen (HBeAg) positive chronic hepatitis B who received peginterferon alfa-2a [Pegasys] were included.
11151941|NCT01886300|OG000|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
11151942|NCT01886300|EG000|Reported Event|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
11151943|NCT01886313|BG000|Baseline|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
10851394|NCT00306202|OG004|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
11151944|NCT01886313|BG001|Baseline|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
11151945|NCT01886313|BG002|Baseline|Total|Total of all reporting groups
11151946|NCT01886313|FG000|Participant Flow|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
10851395|NCT00306202|OG005|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
11151947|NCT01886313|FG001|Participant Flow|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
11151948|NCT01886313|OG000|Outcome|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
11151949|NCT01886313|OG001|Outcome|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
11151950|NCT01886313|EG000|Reported Event|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
11151951|NCT01886313|EG001|Reported Event|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
11151952|NCT01886378|BG000|Baseline|UX007|UX007 dosing was titrated to a target dose of 25-35% of total caloric intake or maximum tolerated dose. Participants were followed to evaluate the effects of UX007 over 24 weeks (Treatment Period), then continued treatment in the Extension Period for an additional 54 weeks for a total of 78 weeks of treatment.
11151953|NCT01886378|FG000|Participant Flow|UX007|UX007 dosing was titrated to a target dose of 25-35% of total caloric intake or maximum tolerated dose. Participants were followed to evaluate the effects of UX007 over 24 weeks (Treatment Period), then continued treatment in the Extension Period for an additional 54 weeks for a total of 78 weeks of treatment.
11151954|NCT01886378|OG000|Outcome|UX007|UX007 dosing was titrated to a target dose of 25-35% of total caloric intake or maximum tolerated dose. Participants were followed to evaluate the effects of UX007 over 24 weeks (Treatment Period), then continued treatment in the Extension Period for an additional 54 weeks for a total of 78 weeks of treatment.
11173816|NCT02017899|OG002|Outcome|S. Sonnei 1790GAHB - 25 mcg|"Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg~S. sonnei 1790GAHB"
10887678|NCT00502307|OG001|Outcome|Double-blind Period: Tivozanib (AV-951)|Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive 1.5 mg/ day of tivozanib for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner.
10887679|NCT00502307|OG002|Outcome|Double-blind Period: Placebo|Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive matching placebo for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner.
10887680|NCT00502307|OG000|Outcome|Investigator Assessment|All assessment were performed by the study Investigator and similarly for IRR.
10887681|NCT00502307|OG001|Outcome|Independent Radiology Reviewer Assessment|All assessment were performed by the study Investigator and similarly for IRR.
11088916|NCT01520909|OG000|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
11088917|NCT01520909|OG000|Outcome|Part 1 (Randmoized Period) -Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
11088918|NCT01520909|OG000|Outcome|Part 1 (Randmoized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
11088919|NCT01520909|OG000|Outcome|Part 1(Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
11088920|NCT01520909|OG000|Outcome|EPart 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
11088921|NCT01520909|OG000|Outcome|Part 1 (Randomized Period) - Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
11151955|NCT01886378|EG000|Reported Event|UX007|UX007 dosing was titrated to a target dose of 25-35% of total caloric intake or maximum tolerated dose. Participants were followed to evaluate the effects of UX007 over 24 weeks (Treatment Period), then continued treatment in the Extension Period for an additional 54 weeks for a total of 78 weeks of treatment.
10887682|NCT00502307|OG000|Outcome|Investigator Assessment (Tivozanib)|All assessment were performed by the study Investigator and similarly for IRR.
10887683|NCT00502307|OG001|Outcome|Investigator Assessment (Placebo)|All assessment were performed by the study Investigator and similarly for IRR.
10887684|NCT00502307|OG002|Outcome|Independent Radiology Reviewer (Tivozanib)|All assessment were performed by the study Investigator and similarly for IRR.
10887685|NCT00502307|OG003|Outcome|Independent Radiology Reviewer (Placebo)|All assessment were performed by the study Investigator and similarly for IRR.
10887686|NCT00502307|OG002|Outcome|Independent Radiology Reviewer Assessment (Tivozanib)|All assessment were performed by the study Investigator and similarly for IRR.
10887687|NCT00502307|OG003|Outcome|Independent Radiology Reviewer Assessment (Placebo)|All assessment were performed by the study Investigator and similarly for IRR.
10887688|NCT00502307|OG000|Outcome|Tivozanib 1.5 mg|A total of 21 subjects received 1.5 mg tivozanib (1.3397 mg free base) in Cycle 1.
10887689|NCT00502307|EG000|Reported Event|Open-label Period: Tivozanib (AV-951)|Subjects were enrolled into the initial, 16-week, open-label period and received tivozanib at a dose of 1.5 mg/day (oral administration). Subjects received tivozanib continuously for 3 weeks followed by 1 week off study drug (1 cycle = 3 weeks on, 1 week off).
10887690|NCT00502307|EG001|Reported Event|Double-blind Period: Tivozanib (AV-951)|Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive 1.5 mg/ day of tivozanib for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner.
10887691|NCT00502307|EG002|Reported Event|Double-blind Period: Placebo|Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive matching placebo for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner.
10887692|NCT00502320|BG000|Baseline|Ramelteon|8 mg pill taken by mouth nightly
10887693|NCT00502320|BG001|Baseline|Placebo|inactive sugar pill taken by mouth nightly
10887694|NCT00502320|BG002|Baseline|Total|Total of all reporting groups
10887695|NCT00502320|FG000|Participant Flow|Ramelteon|8 mg pill taken by mouth nightly
10887696|NCT00502320|FG001|Participant Flow|Placebo|inactive sugar pill taken by mouth nightly
10887697|NCT00502320|OG000|Outcome|Ramelteon|8 mg pill taken by mouth nightly
10887698|NCT00502320|OG001|Outcome|Placebo|inactive sugar pill taken by mouth nightly
10887699|NCT00502320|EG000|Reported Event|Ramelteon|8 mg pill taken by mouth nightly
11151956|NCT01886690|BG000|Baseline|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
11151957|NCT01886690|BG001|Baseline|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
11151958|NCT01886690|BG002|Baseline|Total|Total of all reporting groups
11151959|NCT01886690|FG000|Participant Flow|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
11151960|NCT01886690|FG001|Participant Flow|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
11151961|NCT01886690|OG000|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
11151962|NCT01886690|OG001|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
11151963|NCT01886690|EG000|Reported Event|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
11151964|NCT01886690|EG001|Reported Event|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
11151965|NCT01886716|BG000|Baseline|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
11151966|NCT01886716|BG001|Baseline|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
11151967|NCT01886716|BG002|Baseline|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
11151968|NCT01886716|BG003|Baseline|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
11151969|NCT01886716|BG004|Baseline|Total|Total of all reporting groups
11151970|NCT01886716|FG000|Participant Flow|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
11151971|NCT01886716|FG001|Participant Flow|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
11151972|NCT01886716|FG002|Participant Flow|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
11151973|NCT01886716|FG003|Participant Flow|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
11151974|NCT01886716|OG000|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
11151975|NCT01886716|OG001|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
11151976|NCT01886716|OG002|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
11151977|NCT01886716|OG003|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
11151978|NCT01886716|EG000|Reported Event|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
11151979|NCT01886716|EG001|Reported Event|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
11151980|NCT01886716|EG002|Reported Event|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
11151981|NCT01886716|EG003|Reported Event|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
11151982|NCT01886781|BG000|Baseline|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
11151983|NCT01886781|BG001|Baseline|Placebo|Controls Crytalline cellulose powder
11151984|NCT01886781|BG002|Baseline|Total|Total of all reporting groups
11151985|NCT01886781|FG000|Participant Flow|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
11151986|NCT01886781|FG001|Participant Flow|Placebo|Controls Crytalline cellulose powder
11151987|NCT01886781|OG000|Outcome|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
11151988|NCT01886781|OG001|Outcome|Placebo|Controls Crytalline cellulose powder
11151989|NCT01886781|EG000|Reported Event|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
11151990|NCT01886781|EG001|Reported Event|Placebo|Controls Crytalline cellulose powder
11151991|NCT01886807|BG000|Baseline|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
11151992|NCT01886807|BG001|Baseline|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
11151993|NCT01886807|BG002|Baseline|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
11151994|NCT01886807|BG003|Baseline|Total|Total of all reporting groups
11151995|NCT01886807|FG000|Participant Flow|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
11151996|NCT01886807|FG001|Participant Flow|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
11151997|NCT01886807|FG002|Participant Flow|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
11151998|NCT01886807|OG000|Outcome|(DL Group)|"direct laryngoscopy for nasotracheal intubation without oxygen insufflation~TrueView PCD Video Laryngoscope"
11151999|NCT01886807|OG001|Outcome|(DL-O2 Group)|"direct laryngoscopy for nasotracheal intubation with oxygen insufflation~TrueView PCD Video Laryngoscope"
11152000|NCT01886807|OG002|Outcome|(VL Group)|"nasotracheal intubation using the Truview PCD video laryngoscope~TrueView PCD Video Laryngoscope"
11152001|NCT01886807|OG000|Outcome|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
11152002|NCT01886807|OG001|Outcome|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
11152003|NCT01886807|OG002|Outcome|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
11152004|NCT01886807|EG000|Reported Event|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
11152005|NCT01886807|EG001|Reported Event|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
11152006|NCT01886807|EG002|Reported Event|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
11152007|NCT01886833|BG000|Baseline|Mother-Infant Pair|"The study will involve consenting mother-infant pairs from Kamwala health facility in Lusaka where the Maternal Child Health (MCH). Those generally interested will be invited to the research clinic, where more detailed information about the study is offered. Motivated mothers will be recruited and taken through the written informed consent process by the study nurse.~Enrolled mother-infant pairs will undergo baseline procedures as earlier described. They will then be followed prospectively until about December 2016. They will be expected to come to the clinic for scheduled visits at baseline, 1, 3, 12, 15 and 42 months. They will be urged to come to the clinic for unscheduled visit should the infant be unwell at any time, and particularly each time the infant experiences diarrhoea."
11152008|NCT01886833|FG000|Participant Flow|Mother-infant Pair IgA|Proportion of Immunized Infants Exposed to High Breast Milk anti-rotavirus IgA Who Fail to Seroconvert will be calculated comparing baseline to after 1 month of full immunization.
11152009|NCT01886833|OG000|Outcome|Mother-Infant Pair|The proposed study will recruit a prospective cohort of 420 mother-infant pairs. These will be enrolled at the time of vaccination (6-12 week old infant) and followed for up to four years. Baseline immunological status will be ascertained and seroconversion rates determined a month after full immunization.
11152010|NCT01886833|OG000|Outcome|Mother-Infant Pair|"The study will involve consenting mother-infant pairs from Kamwala health facility in Lusaka where the Maternal Child Health (MCH). Those generally interested will be invited to the research clinic, where more detailed information about the study is offered. Motivated mothers will be recruited and taken through the written informed consent process by the study nurse.~Enrolled mother-infant pairs will undergo baseline procedures as earlier described. They will then be followed prospectively until about December 2016. They will be expected to come to the clinic for scheduled visits at baseline, 1, 3, 12, 15 and 42 months. They will be urged to come to the clinic for unscheduled visit should the infant be unwell at any time, and particularly each time the infant experiences diarrhoea."
11152011|NCT01886833|OG000|Outcome|Mother/Infant Pair|The proposed study will recruit a prospective cohort of 420 mother-infant pairs. These will be enrolled at the time of vaccination (6-12 week old infant) and followed for up to four years. Baseline immunological status will be ascertained and seroconversion rates determined a month after full immunization.
11152012|NCT01886833|OG000|Outcome|Infants|Determination of genotype in every rotavirus causing severe gastroenteritis will be done each time stool samples are collected for diarrhoea. Patients presenting with any diarrhoea will be tested for rotavirus and staged clinically (by Vesikari score). Those with severe disease (e.g., Vesikari >11/20) will be processed for genotype. Thus, we will identify the number of rotavirus cases following vaccination as well as identify the strain in those with severe disease.
11152013|NCT01886833|EG000|Reported Event|Mother-Infant Pair|The proposed study will recruit a prospective cohort of 420 mother-infant pairs. These will be enrolled at the time of vaccination (6-12 week old infant) and followed for up to four years. Baseline immunological status will be ascertained and seroconversion rates determined a month after full immunization.
11152014|NCT01886937|BG000|Baseline|37.5 mg Phentermine First, Then Placebo|"In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.~Other names for phentermine:~adipex ionamin~Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
11152015|NCT01886937|BG001|Baseline|Placebo First, Then 37.5mg Phentermine|"In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.~placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
11152016|NCT01886937|BG002|Baseline|Total|Total of all reporting groups
11173817|NCT02017899|OG003|Outcome|S. Sonnei 1790GAHB - 50 mcg|"Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg~S. sonnei 1790GAHB"
11152017|NCT01886937|FG000|Participant Flow|37.5 mg Phentermine Daily for 7 Days First,Followed by Placebo|"In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.~Other names for phentermine:~adipex ionamin~Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
11152018|NCT01886937|FG001|Participant Flow|Placebo (for Phentermine 37.5mg) First, Followed by Phentermin|"In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.~placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
11152019|NCT01886937|OG000|Outcome|37.5 mg Phentermine Daily for 7 Days|"In this arm, participants receive 37.5mg phentermine for one week .~Other names for phentermine:~adipex ionamin~Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
11152020|NCT01886937|OG001|Outcome|Placebo (for Phentermine 37.5mg)|"In this arm, participants receive Placebo (for 37.5mg phentermine) for 7 days.~placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
11152021|NCT01886937|EG000|Reported Event|37.5 mg Phentermine|"This describes all participants who received 37.5mg phentermine for one week.~Other names for phentermine:~adipex ionamin"
11152022|NCT01886937|EG001|Reported Event|Placebo|This group refers to all participants who received Placebo.
11152023|NCT01887132|BG000|Baseline|Open-Label Donepezil|Donepezil
11152024|NCT01887132|FG000|Participant Flow|Open-Label Donepezil|Donepezil
11152025|NCT01887132|OG000|Outcome|Open-Label Donepezil|Donepezil
11152026|NCT01887132|EG000|Reported Event|Open-Label Donepezil|Donepezil
11152027|NCT01887171|BG000|Baseline|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
11152028|NCT01887171|BG001|Baseline|HTK Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
11152029|NCT01887171|BG002|Baseline|Total|Total of all reporting groups
11152030|NCT01887171|FG000|Participant Flow|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
11152031|NCT01887171|FG001|Participant Flow|HTK Solution Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
11152032|NCT01887171|OG000|Outcome|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
11152033|NCT01887171|OG001|Outcome|HTK Solution Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
11152034|NCT01887171|EG000|Reported Event|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
11152035|NCT01887171|EG001|Reported Event|HTK Solution|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
11152036|NCT01887210|BG000|Baseline|IMB Gaming Adherence Intervention|Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
11152037|NCT01887210|BG001|Baseline|Enhanced Treatment as Usual|Smart pill bottle cap and mobile phone but no game
11152038|NCT01887210|BG002|Baseline|Total|Total of all reporting groups
11152039|NCT01887210|FG000|Participant Flow|IMB Gaming Adherence Intervention|Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
11088922|NCT01520909|OG001|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
11088923|NCT01520909|OG000|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
11088924|NCT01520909|OG001|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
11088925|NCT01520909|OG002|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
11088926|NCT01520909|EG000|Reported Event|Part 1: Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received eltrombopag 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
11088927|NCT01520909|EG001|Reported Event|Part 1: Placebo|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received placebo 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
11088928|NCT01520909|EG002|Reported Event|Part 2: Eltrombopag|In Part 2, participants continued on the same dose of eltrombopag received in Part 1 unless adjustments were warranted according to the dosing guidelines.
11088929|NCT01520922|BG000|Baseline|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
11088930|NCT01520922|BG001|Baseline|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
11088931|NCT01520922|BG002|Baseline|Total|Total of all reporting groups
11088932|NCT01520922|FG000|Participant Flow|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
11088933|NCT01520922|FG001|Participant Flow|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
11088934|NCT01520922|OG000|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
11088935|NCT01520922|OG001|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
11088936|NCT01520922|EG000|Reported Event|Ofatumumab + Bendamustine 70mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
11088937|NCT01520922|EG001|Reported Event|Ofatumumab + Bendamustine 90mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
11088938|NCT01520987|BG000|Baseline|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088939|NCT01520987|BG001|Baseline|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088940|NCT01520987|BG002|Baseline|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088941|NCT01520987|BG003|Baseline|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
11088942|NCT01520987|BG004|Baseline|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088943|NCT01520987|BG005|Baseline|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088944|NCT01520987|BG006|Baseline|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088945|NCT01520987|BG007|Baseline|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
11088946|NCT01520987|BG008|Baseline|Total|Total of all reporting groups
11088947|NCT01520987|FG000|Participant Flow|Caucasian 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
11088948|NCT01520987|FG001|Participant Flow|Caucasian 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
11088949|NCT01520987|FG002|Participant Flow|Caucasian 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
11088950|NCT01520987|FG003|Participant Flow|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
11088951|NCT01520987|FG004|Participant Flow|Japanese 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
11088952|NCT01520987|FG005|Participant Flow|Japanese 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
11088953|NCT01520987|FG006|Participant Flow|Japanese 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
11088954|NCT01520987|FG007|Participant Flow|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
11088955|NCT01520987|OG000|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088956|NCT01520987|OG001|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088957|NCT01520987|OG002|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088958|NCT01520987|OG003|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088959|NCT01520987|OG004|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088960|NCT01520987|OG005|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088961|NCT01520987|EG000|Reported Event|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088962|NCT01520987|EG001|Reported Event|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088963|NCT01520987|EG002|Reported Event|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088964|NCT01520987|EG003|Reported Event|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
11088965|NCT01520987|EG004|Reported Event|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088966|NCT01520987|EG005|Reported Event|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088967|NCT01520987|EG006|Reported Event|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
11088968|NCT01520987|EG007|Reported Event|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
11088969|NCT01521026|BG000|Baseline|Cognitive Training|Cognitive training group
11088970|NCT01521026|BG001|Baseline|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
11088971|NCT01521026|BG002|Baseline|Total|Total of all reporting groups
11088972|NCT01521026|FG000|Participant Flow|Cognitive Training|Cognitive training group
11088973|NCT01521026|FG001|Participant Flow|Standard Pharmacotherapy|Standard pharmacotherapy with regular clinician
11088974|NCT01521026|OG000|Outcome|Cognitive Training|Cognitive training group
11088975|NCT01521026|OG001|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
11088976|NCT01521026|EG000|Reported Event|Cognitive Training|Cognitive training group
11088977|NCT01521026|EG001|Reported Event|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
11088978|NCT01521117|BG000|Baseline|Total|Total of all study completers.
11088979|NCT01521117|FG000|Participant Flow|Donepezil, Then Placebo|Donepezil: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days. After a washout of 4 weeks, Placebo: Use 1 capsule (5 mg) once per day for first 21 days 10mg qday for 21 days.
11088980|NCT01521117|FG001|Participant Flow|Placebo, Then Donepezil|Placebo: Use 1 capsule (5 mg) once per day for first 21 days 10mg qday for 21 days. After a washout of 4 weeks, Donepezil: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.
11088981|NCT01521117|OG000|Outcome|Donepezil|Donepezil: Use 1 capsule (5 mg) of donepezil once per day for 21 days
11088982|NCT01521117|OG001|Outcome|Placebo|Placebo: Use 1 capsule (5 mg) once per day for 21 days
11088983|NCT01521117|EG000|Reported Event|Donepezil|Donepezil: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days in either the first or last 6 weeks of the study.
11088984|NCT01521117|EG001|Reported Event|Placebo|Placebo: Use 1 capsule (5 mg) once per day for first 21 days 10mg qday for 21 days in either the first or last 6 weeks of the study.
11088985|NCT01521260|BG000|Baseline|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
11088986|NCT01521260|BG001|Baseline|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
11088987|NCT01521260|BG002|Baseline|Total|Total of all reporting groups
11088988|NCT01521260|FG000|Participant Flow|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
11152040|NCT01887210|FG001|Participant Flow|Enhanced Treatment as Usual|Smart pill bottle cap and mobile phone but no game
11152041|NCT01887210|OG000|Outcome|IMB Gaming Adherence Intervention|Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
11152042|NCT01887210|OG001|Outcome|Enhanced Treatment as Usual|Smart pill bottle cap and mobile phone but no game
11152043|NCT01887210|EG000|Reported Event|IMB Gaming Adherence Intervention|Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
11152044|NCT01887210|EG001|Reported Event|Enhanced Treatment as Usual|Smart pill bottle cap and mobile phone but no game
11152045|NCT01887327|BG000|Baseline|3.0 mg/kg Stannsoporfin|Participants receive 3.0 mg/kg Stannsoporfin and phototherapy
11152046|NCT01887327|BG001|Baseline|4.5 mg/kg Stannsoporfin|Participants receive 4.5 mg/kg stannsoporfin and phototherapy
11152047|NCT01887327|BG002|Baseline|Placebo|Participants receive placebo and phototherapy
11152048|NCT01887327|BG003|Baseline|Total|Total of all reporting groups
11152049|NCT01887327|FG000|Participant Flow|3.0 mg/kg Stannsoporfin|Participants receive 3.0 mg/kg Stannsoporfin and phototherapy
11152050|NCT01887327|FG001|Participant Flow|4.5 mg/kg Stannsoporfin|Participants receive 4.5 mg/kg stannsoporfin and phototherapy
11152051|NCT01887327|FG002|Participant Flow|Placebo|Participants receive placebo and phototherapy
11152052|NCT01887327|OG000|Outcome|3.0 mg/kg Stannsoporfin|Participants receive 3.0 mg/kg stannsoporfin and phototherapy
11152053|NCT01887327|OG001|Outcome|4.5 mg/kg Stannsoporfin|Participants receive 4.5 mg/kg Stannsoporfin and phototherapy
11152054|NCT01887327|OG002|Outcome|Placebo|Participants receive placebo and phototherapy
11152055|NCT01887327|OG001|Outcome|4.5 mg/kg Stannsoporfin|Participants receive 4.5 mg/kg stannsoporfin and phototherapy
11152056|NCT01887327|EG000|Reported Event|3.0 mg/kg Stannsoporfin|Participants receive 3.0 mg/kg stannsoporfin and phototherapy
11152057|NCT01887327|EG001|Reported Event|4.5mg/kg Stannsoporfin|Participants receive 4.5mg/kg stannsoporfin and phototherapy
11152058|NCT01887327|EG002|Reported Event|Placebo|Participants receive placebo and phototherapy
11152059|NCT01887353|BG000|Baseline|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
11152060|NCT01887353|BG001|Baseline|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
11152061|NCT01887353|BG002|Baseline|Total|Total of all reporting groups
11152062|NCT01887353|FG000|Participant Flow|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
11152063|NCT01887353|FG001|Participant Flow|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
11152064|NCT01887353|OG000|Outcome|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
11152065|NCT01887353|OG001|Outcome|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
11152066|NCT01887353|EG000|Reported Event|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
11152067|NCT01887353|EG001|Reported Event|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
11152068|NCT01887418|BG000|Baseline|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
11152069|NCT01887418|BG001|Baseline|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
11152070|NCT01887418|BG002|Baseline|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
11152071|NCT01887418|BG003|Baseline|Total|Total of all reporting groups
11152072|NCT01887418|FG000|Participant Flow|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
11152073|NCT01887418|FG001|Participant Flow|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
11152074|NCT01887418|FG002|Participant Flow|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
11152075|NCT01887418|OG000|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
11152076|NCT01887418|OG001|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
11152077|NCT01887418|OG002|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
11152078|NCT01887418|EG000|Reported Event|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
11152079|NCT01887418|EG001|Reported Event|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
11152080|NCT01887418|EG002|Reported Event|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
11152081|NCT01887470|BG000|Baseline|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
11152082|NCT01887470|BG001|Baseline|Full Dose Preparation: PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
11173818|NCT02017899|OG004|Outcome|S. Sonnei 1790GAHB - 100 mcg|"Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg~S. sonnei 1790GAHB"
11152083|NCT01887470|BG002|Baseline|Split Dose Preparation; AM Colonscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
11152084|NCT01887470|BG003|Baseline|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
11152085|NCT01887470|BG004|Baseline|Total|Total of all reporting groups
11152086|NCT01887470|FG000|Participant Flow|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
11152087|NCT01887470|FG001|Participant Flow|Full Dose Preparation; PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
11152088|NCT01887470|FG002|Participant Flow|Split Dose Preparation; AM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
11152089|NCT01887470|FG003|Participant Flow|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
11152090|NCT01887470|OG000|Outcome|Regimen A for AM Colonoscopy|"Regimen A for morning colonoscopy~Regimen A"
11152091|NCT01887470|OG001|Outcome|Regimen A for PM Colonoscopy|"Regimen A for afternoon colonoscopy~Regimen A"
11152092|NCT01887470|OG002|Outcome|Regimen B for AM Colonoscopy|"Regimen B for morning colonoscopy~Regimen B"
11152093|NCT01887470|OG003|Outcome|Regimen B for PM Colonoscopy|"Regimen B for afternoon colonoscopy~Regimen B"
11152094|NCT01887470|OG000|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
11152095|NCT01887470|OG000|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
11152096|NCT01887470|OG000|Outcome|Lactulose for Oral Solution|"All patients taking lactulose for oral solution~."
11152097|NCT01887470|EG000|Reported Event|Lactulose for Oral Solution|All patients taking lactulose for oral solution were evaluated as one group for purposes of providing survey data on the use of the product as a bowel preparation agent for colonoscopy.
11152098|NCT01887587|BG000|Baseline|(Modified VXLD) Plus MLN9708|"Vincristine-1.5 mg/m2 to a max dose of 2 mg IV on days 1, 8, 15 and 22~Dexamethasone- 10 mg/m2 orally or IV on days 1-14~Doxorubicin- 60 mg/m2 on day 1 by IV bolus.~For patients without CNS involvement:~Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir)~Methotrexate 12 mg will be administered intrathecally on day 8 (+/-1 day)~For patients with CNS involvement:~-Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir) Triple intrathecal chemotherapy with cytarabine 30 mg, methotrexate 15 mg and hydrocortisone 15 mg on (Day 1, 8, 15 and 22 (+/-1 day)).~MLN9708~Vincristine~Doxorubicin~Dexamethasone"
11152099|NCT01887587|FG000|Participant Flow|(Modified VXLD) Plus MLN9708|"Vincristine-1.5 mg/m2 to a max dose of 2 mg IV on days 1, 8, 15 and 22~Dexamethasone- 10 mg/m2 orally or IV on days 1-14~Doxorubicin- 60 mg/m2 on day 1 by IV bolus.~For patients without central nervous system (CNS) involvement:~Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir)~Methotrexate 12 mg will be administered intrathecally on day 8 (+/-1 day)~For patients with CNS involvement:~-Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir) Triple intrathecal chemotherapy with cytarabine 30 mg, methotrexate 15 mg and hydrocortisone 15 mg on (Day 1, 8, 15 and 22 (+/-1 day))."
11152100|NCT01887587|OG000|Outcome|(Modified VXLD) Plus MLN9708|"Vincristine-1.5 mg/m2 to a max dose of 2 mg IV on days 1, 8, 15 and 22~Dexamethasone- 10 mg/m2 orally or IV on days 1-14~Doxorubicin- 60 mg/m2 on day 1 by IV bolus.~For patients without CNS involvement:~Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir)~Methotrexate 12 mg will be administered intrathecally on day 8 (+/-1 day)~For patients with CNS involvement:~-Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir) Triple intrathecal chemotherapy with cytarabine 30 mg, methotrexate 15 mg and hydrocortisone 15 mg on (Day 1, 8, 15 and 22 (+/-1 day)).~MLN9708~Vincristine~Doxorubicin~Dexamethasone"
11152101|NCT01887587|OG000|Outcome|Modified VXLD Plus MLN9708|"Vincristine -1.5 mg/m2 to a max dose of 2 mg IV on days 1, 8, 15 and 22~Dexamethasone - 10 mg/m2 orally or IV on days 1-14~Doxorubicin - 60 mg/m2 on day 1 by IV bolus.~MLN9708 (Ixazomib)- 2.3 mg orally on days 1, 8 and 15. Subsequent escalations will be to 3mg or 4 mg, respectively, on days 1, 8 and 15 based on the dosing schema.~For patients without CNS involvement:~Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir)~Methotrexate 12 mg will be administered intrathecally on day 8 (+/-1 day)~For patients with CNS involvement:~-Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir) Triple intrathecal chemotherapy with cytarabine 30 mg, methotrexate 15 mg and hydrocortisone 15 mg on (Day 1, 8, 15 and 22 (+/-1 day)."
11152102|NCT01887587|EG000|Reported Event|(Modified VXLD) Plus MLN9708|"Vincristine-1.5 mg/m2 to a max dose of 2 mg IV on days 1, 8, 15 and 22~Dexamethasone- 10 mg/m2 orally or IV on days 1-14~Doxorubicin- 60 mg/m2 on day 1 by IV bolus.~For patients without CNS involvement:~Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir)~Methotrexate 12 mg will be administered intrathecally on day 8 (+/-1 day)~For patients with CNS involvement:~-Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir) Triple intrathecal chemotherapy with cytarabine 30 mg, methotrexate 15 mg and hydrocortisone 15 mg on (Day 1, 8, 15 and 22 (+/-1 day)).~MLN9708~Vincristine~Doxorubicin~Dexamethasone"
11152103|NCT01887600|BG000|Baseline|Roxadustat|Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for at least 52 weeks up to a maximum of 104 weeks.
11152104|NCT01887600|BG001|Baseline|Placebo|Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received matching placebo for at least 52 weeks up to a maximum of 104 weeks.
11152105|NCT01887600|BG002|Baseline|Total|Total of all reporting groups
11152106|NCT01887600|FG000|Participant Flow|Roxadustat|Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for at least 52 weeks up to a maximum of 104 weeks.
11152107|NCT01887600|FG001|Participant Flow|Placebo|Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received matching placebo for at least 52 weeks up to a maximum of 104 weeks.
11152108|NCT01887600|OG000|Outcome|Roxadustat|Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for at least 52 weeks up to a maximum of 104 weeks.
11152109|NCT01887600|OG001|Outcome|Placebo|Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received matching placebo for at least 52 weeks up to a maximum of 104 weeks.
11152110|NCT01887600|OG001|Outcome|Placebo|Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received matching placebo for at least 52 weeks up to a maximum of 104 weeks.Participants were treated with placebo three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted based on the predefined targeted hemoglobin (Hb) values.
11152111|NCT01887600|EG000|Reported Event|Roxadustat|Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for at least 52 weeks up to a maximum of 104 weeks.
11173819|NCT02017899|OG005|Outcome|Placebo|"2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses~Placebo"
11173820|NCT02017899|EG000|Reported Event|S. Sonnei 1790GAHB - 1 mcg|"Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg~S. sonnei 1790GAHB"
10887700|NCT00502320|EG001|Reported Event|Placebo|inactive sugar pill taken by mouth nightly
11088989|NCT01521260|FG001|Participant Flow|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
11088990|NCT01521260|OG000|Outcome|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
11088991|NCT01521260|OG001|Outcome|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
11088992|NCT01521260|EG000|Reported Event|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
11088993|NCT01521260|EG001|Reported Event|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
11088994|NCT01521364|BG000|Baseline|Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
11088995|NCT01521364|FG000|Participant Flow|0mg, 250mg and 500mg Claritromycin|Patients receive 300mg linezolid twice a day during entire study.
11088996|NCT01521364|OG000|Outcome|0mg Claritrhomycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
11088997|NCT01521364|OG001|Outcome|250mg Clarithromycin|
11088998|NCT01521364|OG002|Outcome|500mg Clarithromycin|
11088999|NCT01521364|OG000|Outcome|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
11089000|NCT01521364|OG001|Outcome|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
11089001|NCT01521364|OG002|Outcome|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
11089002|NCT01521364|EG000|Reported Event|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
11089003|NCT01521364|EG001|Reported Event|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
11089004|NCT01521364|EG002|Reported Event|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
11089005|NCT01521494|BG000|Baseline|PA21 750 mg/Day|PA21
11089006|NCT01521494|BG001|Baseline|PA21 1500 mg/Day|PA21
11089007|NCT01521494|BG002|Baseline|PA21 2250 mg/Day|PA21
11089008|NCT01521494|BG003|Baseline|PA21 3000 mg/Day|PA21
11089009|NCT01521494|BG004|Baseline|Placebo|Placebo
11089010|NCT01521494|BG005|Baseline|Total|Total of all reporting groups
11089011|NCT01521494|FG000|Participant Flow|PA21 750 mg/Day|PA21
11089012|NCT01521494|FG001|Participant Flow|PA21 1500 mg/Day|PA21
11089013|NCT01521494|FG002|Participant Flow|PA21 2250 mg/Day|PA21
11089014|NCT01521494|FG003|Participant Flow|PA21 3000 mg/Day|PA21
11089015|NCT01521494|FG004|Participant Flow|Placebo|Placebo
11089016|NCT01521494|OG000|Outcome|PA21 750 mg/Day|PA21
11089017|NCT01521494|OG001|Outcome|PA21 1500 mg/Day|PA21
11089018|NCT01521494|OG002|Outcome|PA21 2250 mg/Day|PA21
11089019|NCT01521494|OG003|Outcome|PA21 3000 mg/Day|PA21
11089020|NCT01521494|OG004|Outcome|Placebo|Placebo
11089021|NCT01521494|EG000|Reported Event|PA21 750 mg/Day|PA21
11089022|NCT01521494|EG001|Reported Event|PA21 1500 mg/Day|PA21
11089023|NCT01521494|EG002|Reported Event|PA21 2250 mg/Day|PA21
11089024|NCT01521494|EG003|Reported Event|PA21 3000 mg/Day|PA21
11089025|NCT01521494|EG004|Reported Event|Placebo|Placebo
11089026|NCT01521507|BG000|Baseline|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
11089027|NCT01521507|BG001|Baseline|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
11089028|NCT01521507|BG002|Baseline|Total|Total of all reporting groups
11089029|NCT01521507|FG000|Participant Flow|LipiFlow Treatment|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:~One LipiFlow Treatment - After subjects received one LipiFlow treatment at randomization, no other MGD or dry eye treatment was prescribed for the study duration.~Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.~Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
11089030|NCT01521507|FG001|Participant Flow|Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment|"Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3 months in Stage 1. Then, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:~One LipiFlow Treatment - After subjects received one LipiFlow treatment at crossover, no other MGD or dry eye treatment was prescribed for the study duration.~Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.~Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
11089031|NCT01521507|OG000|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
11089032|NCT01521507|OG001|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
11089033|NCT01521507|OG000|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
11089034|NCT01521507|OG001|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
11089035|NCT01521507|OG002|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
11089036|NCT01521507|OG003|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
11089037|NCT01521507|OG000|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
11089038|NCT01521507|OG001|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
11089039|NCT01521507|EG000|Reported Event|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
11089040|NCT01521507|EG001|Reported Event|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
11089041|NCT01521507|EG002|Reported Event|Crossover LipiFlow Treatment|After using twice-daily, standardized warm compress therapy and lid hygiene for 3 months, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
11089042|NCT01521546|BG000|Baseline|Eplerenone|"active study drug~eplerenone: 25mg tablet, once daily by mouth for 12 months"
11089043|NCT01521546|BG001|Baseline|Placebo|"placebo~placebo: one tablet by mouth daily for 12 months"
11089044|NCT01521546|BG002|Baseline|Total|Total of all reporting groups
11089045|NCT01521546|FG000|Participant Flow|Placebo|"placebo~placebo: one tablet by mouth daily for 12 months"
11089046|NCT01521546|FG001|Participant Flow|Eplerenone|"active study drug~eplerenone: 25mg tablet, once daily by mouth for 12 months"
11089047|NCT01521546|OG000|Outcome|Placebo|placebo: one tablet by mouth daily for 12 months
11089048|NCT01521546|OG001|Outcome|Eplerenone|eplerenone one tablet by mouth daily for 12 months
11089049|NCT01521546|EG000|Reported Event|Placebo|placebo one tablet daily for 12 months
11089050|NCT01521546|EG001|Reported Event|Eplerenone|eplerenone one tablet daily for 12 months
11089051|NCT01521559|BG000|Baseline|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
11089052|NCT01521559|BG001|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
11089053|NCT01521559|BG002|Baseline|Total|Total of all reporting groups
11089054|NCT01521559|FG000|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
11089055|NCT01521559|FG001|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
11089056|NCT01521559|OG000|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
11089057|NCT01521559|OG001|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
11089058|NCT01521559|OG001|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24
11089059|NCT01521559|EG000|Reported Event|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
11089060|NCT01521559|EG001|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
11089061|NCT01521780|BG000|Baseline|All Participants|Participants who enrolled in the study
11089062|NCT01521780|FG000|Participant Flow|Imaging|Magnetic resonance imaging (MRI) of Hepatocellular carcinoma (HCC) tumor.
11089063|NCT01521780|FG001|Participant Flow|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
11089064|NCT01521780|FG002|Participant Flow|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
11089065|NCT01521780|OG000|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
11089066|NCT01521780|OG001|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
11089067|NCT01521780|OG002|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
11089068|NCT01521780|OG000|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
11089069|NCT01521780|EG000|Reported Event|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
11089070|NCT01521780|EG001|Reported Event|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
11089071|NCT01521780|EG002|Reported Event|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
11089072|NCT01521845|BG000|Baseline|Omega 3|receive omega 3 in addition to standard treatment
11089073|NCT01521845|BG001|Baseline|Control|This group is without omega 3 : just receives standard treatment
11089074|NCT01521845|BG002|Baseline|Total|Total of all reporting groups
11089075|NCT01521845|FG000|Participant Flow|Omega 3|receive omega 3 in addition to standard treatment
11089076|NCT01521845|FG001|Participant Flow|Control|This group is without omega 3 : just receives standard treatment
11089077|NCT01521845|OG000|Outcome|Omega 3|receive omega 3 in addition to standard treatment
11089078|NCT01521845|OG001|Outcome|Control|This group is without omega 3 : just receives standard treatment
11089079|NCT01521845|EG000|Reported Event|Omega 3|receive omega 3 in addition to standard treatment
11089080|NCT01521845|EG001|Reported Event|Control|This group is without omega 3 : just receives standard treatment
11089081|NCT01521871|BG000|Baseline|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
11152112|NCT01887600|EG001|Reported Event|Placebo|Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received matching placebo for at least 52 weeks up to a maximum of 104 weeks.
11152113|NCT01887678|BG000|Baseline|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
11152114|NCT01887678|BG001|Baseline|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
11152115|NCT01887678|BG002|Baseline|Total|Total of all reporting groups
11152116|NCT01887678|FG000|Participant Flow|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
11152117|NCT01887678|FG001|Participant Flow|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
11152118|NCT01887678|OG000|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
11152119|NCT01887678|OG001|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
11152120|NCT01887678|EG000|Reported Event|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
11152121|NCT01887678|EG001|Reported Event|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
11152122|NCT01887717|BG000|Baseline|TheraSphere|Participants received TheraSphere at a dose consistent with the approved package insert to the treated lobe of the liver. TheraSphere was administered through the hepatic artery. The targeted dose was 120 Gy + 10%. Dose reduction to a minimum dose of 80 Gy + 10% was permitted to manage radiation exposure to the lungs. Re-treatment of the same participant/lobe with further cycles of TheraSphere was permitted if a treatable progression was detected during follow-up evaluations. Any re-treatment took place at least 28 days after the previous TheraSphere treatment administered to that lobe. Participants could receive a subsequent TheraSphere administration in the absence of radiological progression criteria at the Investigator's discretion. A maximum of 3 TheraSphere administrations was permitted.
11152123|NCT01887717|BG001|Baseline|Sorafenib|Participants received sorafenib, oral tablets, 400 milligrams (mg) twice daily in accordance with the package insert. Treatment was to continue until the participant was no longer clinically benefiting from therapy or until unacceptable toxicity occurred. Medically appropriate dose adjustments and drug holidays due to adverse events (AEs) and toxicity were allowed.
11152124|NCT01887717|BG002|Baseline|Total|Total of all reporting groups
11152125|NCT01887717|FG000|Participant Flow|TheraSphere|Participants received TheraSphere at a dose consistent with the approved package insert to the treated lobe of the liver. TheraSphere was administered through the hepatic artery. The targeted dose was 120 Gy + 10%. Dose reduction to a minimum dose of 80 Gy + 10% was permitted to manage radiation exposure to the lungs. Re-treatment of the same participant/lobe with further cycles of TheraSphere was permitted if a treatable progression was detected during follow-up evaluations. Any re-treatment took place at least 28 days after the previous TheraSphere treatment administered to that lobe. Participants could receive a subsequent TheraSphere administration in the absence of radiological progression criteria at the Investigator's discretion. A maximum of 3 TheraSphere administrations was permitted.
11173821|NCT02017899|EG001|Reported Event|S. Sonnei 1790GAHB - 5 mcg|"Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg~S. sonnei 1790GAHB"
11152126|NCT01887717|FG001|Participant Flow|Sorafenib|Participants received sorafenib, oral tablets, 400 milligrams (mg) twice daily in accordance with the package insert. Treatment was to continue until the participant was no longer clinically benefiting from therapy or until unacceptable toxicity occurred. Medically appropriate dose adjustments and drug holidays due to adverse events (AEs) and toxicity were allowed.
11152127|NCT01887717|OG000|Outcome|TheraSphere|Participants received TheraSphere at a dose consistent with the approved package insert to the treated lobe of the liver. TheraSphere was administered through the hepatic artery. The targeted dose was 120 Gy + 10%. Dose reduction to a minimum dose of 80 Gy + 10% was permitted to manage radiation exposure to the lungs. Re-treatment of the same participant/lobe with further cycles of TheraSphere was permitted if a treatable progression was detected during follow-up evaluations. Any re-treatment took place at least 28 days after the previous TheraSphere treatment administered to that lobe. Participants could receive a subsequent TheraSphere administration in the absence of radiological progression criteria at the Investigator's discretion. A maximum of 3 TheraSphere administrations was permitted.
11152128|NCT01887717|OG001|Outcome|Sorafenib|Participants received sorafenib, oral tablets, 400 milligrams (mg) twice daily in accordance with the package insert. Treatment was to continue until the participant was no longer clinically benefiting from therapy or until unacceptable toxicity occurred. Medically appropriate dose adjustments and drug holidays due to adverse events (AEs) and toxicity were allowed.
11152129|NCT01887717|EG000|Reported Event|TheraSphere|Participants received TheraSphere at a dose consistent with the approved package insert to the treated lobe of the liver. TheraSphere was administered through the hepatic artery. The targeted dose was 120 Gy + 10%. Dose reduction to a minimum dose of 80 Gy + 10% was permitted to manage radiation exposure to the lungs. Re-treatment of the same participant/lobe with further cycles of TheraSphere was permitted if a treatable progression was detected during follow-up evaluations. Any re-treatment took place at least 28 days after the previous TheraSphere treatment administered to that lobe. Participants could receive a subsequent TheraSphere administration in the absence of radiological progression criteria at the Investigator's discretion. A maximum of 3 TheraSphere administrations was permitted.
11152130|NCT01887717|EG001|Reported Event|Sorafenib|Participants received sorafenib, oral tablets, 400 milligrams (mg) twice daily in accordance with the package insert. Treatment was to continue until the participant was no longer clinically benefiting from therapy or until unacceptable toxicity occurred. Medically appropriate dose adjustments and drug holidays due to adverse events (AEs) and toxicity were allowed.
11152131|NCT01887990|BG000|Baseline|Suicidal, Depression With Ketamine|"suicidal and depressed, no substance use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
11152132|NCT01887990|BG001|Baseline|Suicidal, Depression With Saline|"suicidal and depressed, no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
11152133|NCT01887990|BG002|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed, opioid use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
11152134|NCT01887990|BG003|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed,opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
11152135|NCT01887990|BG004|Baseline|Total|Total of all reporting groups
11152136|NCT01887990|FG000|Participant Flow|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose in patients with suicidal ideatin and depression without substance use~Ketamine"
11152137|NCT01887990|FG001|Participant Flow|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
11152138|NCT01887990|FG002|Participant Flow|Suicidal, Depression and Opioid Use With Ketamine|suicidal, depressed with opioid use, given 0.2 mg/kg ketamine one time dose IV infusion
11152139|NCT01887990|FG003|Participant Flow|Suicidal, Depression With Opioid Use With Saline|suicidal, depression with opioid use, given saline IV
11152140|NCT01887990|OG000|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
11152141|NCT01887990|OG001|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
11152142|NCT01887990|OG002|Outcome|Suicidal, Opioid Use With Ketamine|suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
11152143|NCT01887990|OG003|Outcome|Suicidal, Opioid Use With Saline|Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
11152144|NCT01887990|OG002|Outcome|Suicidal, Opioid Use With Ketamine|suicidal pts who have used opioids, in the ketamine treatment arm
11152145|NCT01887990|OG003|Outcome|Suicidal, Opioid Use With Saline|suicidal patients who use opioids who received saline infusion or placebo
11152146|NCT01887990|EG000|Reported Event|Suicidal, Depression With Ketamine|"Suicidal with depression and no substance use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
11152147|NCT01887990|EG001|Reported Event|Suicidal, Depression With Saline|"Suicidal with depression and no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
11152148|NCT01887990|EG002|Reported Event|Suicidal, Depression and Opioid Use With Ketamine|"Suicidal with depression and opioid use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
11152149|NCT01887990|EG003|Reported Event|Suicidal, Depression and Opioid With Saline|"Suicidal with depression and opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
11152150|NCT01888003|BG000|Baseline|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
11152151|NCT01888003|BG001|Baseline|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
11152152|NCT01888003|BG002|Baseline|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
11152153|NCT01888003|BG003|Baseline|Total|Total of all reporting groups
11152154|NCT01888003|FG000|Participant Flow|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
11152155|NCT01888003|FG001|Participant Flow|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
11152156|NCT01888003|FG002|Participant Flow|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
11152157|NCT01888003|OG000|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
11152158|NCT01888003|OG001|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
11152159|NCT01888003|OG002|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
11173822|NCT02017899|EG002|Reported Event|S. Sonnei 1790GAHB - 25 mcg|"Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg~S. sonnei 1790GAHB"
11173823|NCT02017899|EG003|Reported Event|S. Sonnei 1790GAHB - 50 mcg|"Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg~S. sonnei 1790GAHB"
11152160|NCT01888003|EG000|Reported Event|Anemia Treatment Group (AMG)|"Patients diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days, -7 days before their planned surgery, and if indicated, based on labs, testing on the day of their surgery"
11152161|NCT01888003|EG001|Reported Event|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
11152162|NCT01888003|EG002|Reported Event|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
11152163|NCT01888367|BG000|Baseline|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
11152164|NCT01888367|BG001|Baseline|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
11152165|NCT01888367|BG002|Baseline|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
11152166|NCT01888367|BG003|Baseline|Total|Total of all reporting groups
11152167|NCT01888367|FG000|Participant Flow|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
11152168|NCT01888367|FG001|Participant Flow|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
11152169|NCT01888367|FG002|Participant Flow|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
11152170|NCT01888367|OG000|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
11152171|NCT01888367|OG001|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
11152172|NCT01888367|OG002|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
11152173|NCT01888367|EG000|Reported Event|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
11152174|NCT01888367|EG001|Reported Event|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
11152175|NCT01888367|EG002|Reported Event|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
11152176|NCT01888432|BG000|Baseline|EVR+Reduced TAC|Everolimus + reduced tacrolimus ± corticosteroids
11152177|NCT01888432|BG001|Baseline|TAC Control|Standard tacrolimus ± corticosteroids
11152178|NCT01888432|BG002|Baseline|Total|Total of all reporting groups
11152179|NCT01888432|FG000|Participant Flow|EVR+Reduced TAC|Everolimus + reduced tacrolimus ± corticosteroids
11152180|NCT01888432|FG001|Participant Flow|TAC Control|Standard tacrolimus ± corticosteroids
11152181|NCT01888432|OG000|Outcome|EVR+Reduced TAC|Everolimus + reduced tacrolimus ± corticosteroids
11152182|NCT01888432|OG001|Outcome|TAC Control|Standard tacrolimus ± corticosteroids
11152183|NCT01888432|EG000|Reported Event|AE From Day 1 to Month 24_EVR+Reduced TAC|Everolimus + reduced tacrolimus ± corticosteroids
11152184|NCT01888432|EG001|Reported Event|AE From Day 1 to Month 24_TAC Control|Standard tacrolimus ± corticosteroids
11152185|NCT01888432|EG002|Reported Event|AE From Month 24 to Month 36_EVR+Reduced TAC|Everolimus + reduced tacrolimus ± corticosteroids
11152186|NCT01888432|EG003|Reported Event|AE From Month 24 to Month 36_TAC Control|Standard tacrolimus ± corticosteroids
11152187|NCT01888484|BG000|Baseline|All Patients|"All patients.~The data are reported as the overall population as it was not the intent of the protocol to report analysis by age group"
11152188|NCT01888484|FG000|Participant Flow|Children ≥2 Years <6 Years|Children ≥2 Years <6 Years
11152189|NCT01888484|FG001|Participant Flow|Children Aged ≥6 to <12 Years|Children Aged ≥6 to <12 years
11152190|NCT01888484|FG002|Participant Flow|Adolescents ≥12 Years <17 Years|Adolescents ≥12 Years <17 Years
11152191|NCT01888484|FG003|Participant Flow|Adults ≥17 Years ≤75 Years|Adults ≥17 Years ≤75 Years
11152192|NCT01888484|OG000|Outcome|All Patients|All patients
11152193|NCT01888484|OG000|Outcome|Total Patients|All patients
11152194|NCT01888484|EG000|Reported Event|All Patients|All patients
11152195|NCT01888497|BG000|Baseline|Entire Study Population|All participants randomized to receive diphenhydramine citrate first, gabapentin first, triazolam first or placebo first.
11152196|NCT01888497|FG000|Participant Flow|Diphenhydramine Citrate, Gabapentin, Placebo, Triazolam|A single dose of 1 diphenhydramine citrate 76 milligram (mg) capsule and 2 placebo tablets orally in first intervention period followed by a single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in second intervention period, then a single dose of 1 placebo capsule and 2 placebo tablets orally in third intervention period and then a single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in fourth intervention period. Each intervention period consisted of dosing day on which the study treatment was administered at night followed by testing day. A washout period of 7 to 14 days was maintained between each intervention period.
11152197|NCT01888497|FG001|Participant Flow|Gabapentin, Triazolam, Diphenhydramine Citrate, Placebo|A single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in first intervention period followed by a single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in second intervention period then a single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in third intervention period and then a single dose of 1 placebo capsule and 2 placebo tablets orally in fourth intervention period. Each intervention period consisted of dosing day on which the study treatment was administered at night followed by testing day. A washout period of 7 to 14 days was maintained between each intervention period.
11152198|NCT01888497|FG002|Participant Flow|Triazolam, Placebo, Gabapentin, Diphenhydramine Citrate|A single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in first intervention period followed by 1 placebo capsule and 2 placebo tablets orally in second intervention period then a single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in third intervention period and then a single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in fourth intervention period. Each intervention period consisted of dosing day on which the study treatment was administered at night followed by testing day. A washout period of 7 to 14 days was maintained between each intervention period.
11152199|NCT01888497|FG003|Participant Flow|Placebo, Diphenhydramine Citrate, Triazolam, Gabapentin|A single dose of 1 placebo capsule and 2 placebo tablets orally in first intervention period followed by a single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in second intervention period then a single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in third intervention period and then a single dose of gabapentin 250 mg capsule and 2 placebo tablets orally in fourth intervention period. Each intervention period consisted of dosing day on which the study treatment was administered at night followed by testing day. A washout period of 7 to 14 days was maintained between each intervention period.
11152200|NCT01888497|OG000|Outcome|Placebo|A single dose of 1 placebo capsule and 2 placebo tablets orally in one of the four intervention periods.
11152201|NCT01888497|OG001|Outcome|Gabapentin|A single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in one of the four intervention periods.
11152202|NCT01888497|OG002|Outcome|Diphenhydramine Citrate|A single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in one of the four intervention periods.
11152203|NCT01888497|OG003|Outcome|Triazolam|A single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in one of the four intervention periods.
11152204|NCT01888497|EG000|Reported Event|Placebo|A single dose of 1 placebo capsule and 2 placebo tablets orally in one of the four intervention periods.
11152205|NCT01888497|EG001|Reported Event|Gabapentin|A single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in one of the four intervention periods.
11152206|NCT01888497|EG002|Reported Event|Diphenhydramine Citrate|A single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in one of the four intervention periods.
11152207|NCT01888497|EG003|Reported Event|Triazolam|A single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in one of the four intervention periods.
11152208|NCT01888640|BG000|Baseline|Active TENS|"Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 10 to100 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152209|NCT01888640|BG001|Baseline|Placebo TENS|"This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 10 to100 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152210|NCT01888640|BG002|Baseline|no TENS (Standard Care)|Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
11152211|NCT01888640|BG003|Baseline|Total|Total of all reporting groups
11152212|NCT01888640|FG000|Participant Flow|Active TENS|"Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 10 to100 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11173824|NCT02017899|EG004|Reported Event|S. Sonnei 1790GAHB - 100 mcg|"Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg~S. sonnei 1790GAHB"
11173825|NCT02017899|EG005|Reported Event|Placebo|"2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses~Placebo"
11152213|NCT01888640|FG001|Participant Flow|Placebo TENS|"This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 10 to100 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152214|NCT01888640|FG002|Participant Flow|No TENS (Standard Care)|Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
11152215|NCT01888640|OG000|Outcome|Active TENS|"Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 10 to100 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152216|NCT01888640|OG001|Outcome|Placebo TENS|"This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 10 to100 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152217|NCT01888640|OG002|Outcome|No TENS (Standard Care)|Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
11152218|NCT01888640|OG000|Outcome|Active TENS|"Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 2-125 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152219|NCT01888640|OG001|Outcome|Placebo TENS|"This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 2-125 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152220|NCT01888640|EG000|Reported Event|Active TENS|"Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 10 to100 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152221|NCT01888640|EG001|Reported Event|Placebo TENS|"This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.~TENS: TENS Parameters: Active TENS and Placebo TENS~TENS Frequency - 10 to100 Hz~TENS Pulse Width - 200 µs~TENS Intensity - Maximal tolerable intensity~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.~Administration - Daily~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.~Placebo TENS Unit Active TENS unit Stand Care - no TENS"
11152222|NCT01888640|EG002|Reported Event|No TENS (Standard Care)|Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
11152223|NCT01888640|EG003|Reported Event|Pre-Randomization|Participants who attended visit 1 or 2 prior to randomization to intervention
11152224|NCT01888874|BG000|Baseline|Placebo|Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
11152225|NCT01888874|BG001|Baseline|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11152226|NCT01888874|BG002|Baseline|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11152227|NCT01888874|BG003|Baseline|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11152228|NCT01888874|BG004|Baseline|GLPG0634 25 mg BID|Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
11152229|NCT01888874|BG005|Baseline|GLPG0634 50 mg BID|Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
11152230|NCT01888874|BG006|Baseline|GLPG0634 100 mg BID|Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
11152231|NCT01888874|BG007|Baseline|Total|Total of all reporting groups
11152232|NCT01888874|FG000|Participant Flow|Placebo|Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.
11152233|NCT01888874|FG001|Participant Flow|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11152234|NCT01888874|FG002|Participant Flow|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11152235|NCT01888874|FG003|Participant Flow|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11152236|NCT01888874|FG004|Participant Flow|GLPG0634 25 mg BID|Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
11152237|NCT01888874|FG005|Participant Flow|GLPG0634 50 mg BID|Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
11152238|NCT01888874|FG006|Participant Flow|GLPG0634 100 mg BID|Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
11152239|NCT01888874|OG000|Outcome|Placebo|Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.
11152240|NCT01888874|OG001|Outcome|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11152241|NCT01888874|OG002|Outcome|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11152242|NCT01888874|OG003|Outcome|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11152243|NCT01888874|OG004|Outcome|GLPG0634 25 mg BID|Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
11152244|NCT01888874|OG005|Outcome|GLPG0634 50 mg BID|Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
11152245|NCT01888874|OG006|Outcome|GLPG0634 100 mg BID|Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
11152246|NCT01888874|OG000|Outcome|Placebo|Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
11152247|NCT01888874|EG000|Reported Event|Placebo|Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
11152248|NCT01888874|EG001|Reported Event|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11152249|NCT01888874|EG002|Reported Event|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11152250|NCT01888874|EG003|Reported Event|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11152251|NCT01888874|EG004|Reported Event|GLPG0634 25 mg BID|Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
11152252|NCT01888874|EG005|Reported Event|GLPG0634 50 mg BID|Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
11152253|NCT01888874|EG006|Reported Event|GLPG0634 100 mg BID|Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
11152254|NCT01888900|BG000|Baseline|Hepatitis C Virus Genotype 1A|subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
11152255|NCT01888900|BG001|Baseline|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
11152256|NCT01888900|BG002|Baseline|Total|Total of all reporting groups
11152257|NCT01888900|FG000|Participant Flow|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
11152258|NCT01888900|FG001|Participant Flow|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
11152259|NCT01888900|OG000|Outcome|Hepatitis C Virus Genotype 1A|Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
11152260|NCT01888900|OG001|Outcome|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
11152261|NCT01888900|OG000|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
11152262|NCT01888900|OG001|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
11152263|NCT01888900|EG000|Reported Event|Hepatitis C Virus Genotype 1A|"Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.~Asunaprevir, daclatsvir, peginterferon, ribavirin"
11152264|NCT01888900|EG001|Reported Event|Hepatitis C Virus Genotype 1B|"subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks and undergo paired liver biopsies, pre-treatment and either at 2 or 4 weeks after starting therapy.~Asunaprevir and Daclatsvir"
11152265|NCT01888952|BG000|Baseline|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
11152266|NCT01888952|FG000|Participant Flow|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
11152267|NCT01888952|OG000|Outcome|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
11152268|NCT01888952|EG000|Reported Event|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
11152269|NCT01888965|BG000|Baseline|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
11152270|NCT01888965|FG000|Participant Flow|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
11152271|NCT01888965|OG000|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
11152272|NCT01888965|EG000|Reported Event|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
11152273|NCT01889069|BG000|Baseline|Diffuse Large B-Cell Lymphoma (DLBCL)|Participants with DLBCL, who had received at least 4 doses of rituximab 1400 mg SC once a month during the treatment phase, up to a maximum of 7 cycles, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); as per standard local practice.
11152274|NCT01889069|BG001|Baseline|Follicular Lymphoma (FL)|Participants with CD20+ non-Hodgkin's (FL), who had received at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.
11152275|NCT01889069|BG002|Baseline|Total|Total of all reporting groups
11152276|NCT01889069|FG000|Participant Flow|Subcutaneous (SC) Rituximab|Participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.
11152277|NCT01889069|OG000|Outcome|Diffuse Large B-Cell Lymphoma (DLBCL)|Participants with DLBCL, who had received at least 4 doses of rituximab 1400 mg SC once a month during the treatment phase, up to a maxium of 7 cycles, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); as per standard local practice.
11152278|NCT01889069|OG001|Outcome|Follicular Lymphoma (FL)|Participants with CD20+ non-Hodgkin's (FL), who had received at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.
11152279|NCT01889069|OG002|Outcome|Subcutaneous (SC) Rituximab|Participants with CD20+ diffuse large B-cell lymphoma (DLBCL) or non-Hodgkin's follicular lymphoma (FL), who received at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.
11152280|NCT01889069|OG000|Outcome|Follicular Lymphoma (FL)|Participants with CD20+ non-Hodgkin's (FL), who had received at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.
11152281|NCT01889069|OG000|Outcome|Diffuse Large B-Cell Lymphoma (DLBCL) R-CHOP-14|Cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 14 days
11152282|NCT01889069|OG001|Outcome|Diffuse Large B-Cell Lymphoma (DLBCL) R-CHOP-21|Cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 21 days
11152283|NCT01889069|EG000|Reported Event|Diffuse Large B-Cell Lymphoma (DLBCL)|Participants with DLBCL, who had received at least 4 doses of rituximab 1400 mg SC once a month during the treatment phase, up to a maxium of 7 cycles, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); as per standard local practice.
11152284|NCT01889069|EG001|Reported Event|Follicular Lymphoma (FL)|Participants with CD20+ non-Hodgkin's (FL), who had received at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.
11152285|NCT01889251|BG000|Baseline|Ocriplasmin|Single intravitreal injection to the study eye at baseline
11152286|NCT01889251|BG001|Baseline|Sham Injection|Single sham injection to the study eye at baseline
11152287|NCT01889251|BG002|Baseline|Total|Total of all reporting groups
11152288|NCT01889251|FG000|Participant Flow|Ocriplasmin|Single intravitreal injection to the study eye at baseline
11152289|NCT01889251|FG001|Participant Flow|Sham Injection|Single sham injection to the study eye at baseline
11152290|NCT01889251|OG000|Outcome|Ocriplasmin|Single intravitreal injection to the study eye at baseline
11152291|NCT01889251|OG001|Outcome|Sham Injection|Single sham injection to the study eye at baseline
11152292|NCT01889251|EG000|Reported Event|Ocriplasmin|Single intravitreal injection to the study eye at baseline
11152293|NCT01889251|EG001|Reported Event|Sham Injection|Single sham injection to the study eye at baseline
11152294|NCT01889355|BG000|Baseline|Demographics|Age group ranged from ages 18-86, Male and female with both Type 1 and Type 2 diabetics. Race was both white, black/African American and Hispanic who are able to read and understand English per the subject consent form.
11152295|NCT01889355|FG000|Participant Flow|Study Procedure|"5.5 Evaluation Procedure The evaluation shall be performed in the following sequence and be supervised by one or more healthcare providers trained in the use of the device under evaluation (ISO 15197:2013 8.1).~Briefly describe to the subject that the goal of this study is to obtain a blood glucose reading, describe the study procedures, and obtain written informed consent ensuring all questions are answered.~For each consenting study subject, assign a sequential User ID number and obtain inclusion criteria, exclusion criteria, and user demographics.~Perform a urine pregnancy test for women of childbearing potential if pregnancy status unknown.~Locate subjects to a private area where they are not able to see others performing the test.~The trained technician will put on a new pair of gloves.~Provide the subject with an AgaMatrix meter, test strips, the system kit lancing device and lancets. Prior to performing self-testing, each study subject shall"
11152296|NCT01889355|OG000|Outcome|Subject Population, Inclusion and Exclusion|"This clinical study will consist of at least 50 evaluable subjects who meet all inclusion/exclusion criteria.~Subjects shall be selected using the consecutive sampling method. All diabetic subjects who volunteer for the study and qualify in accordance with the study inclusion and exclusion criteria, the user requirements established by the manufacturer for the blood-glucose system (e.g. packed cell volume within the system's specified limits), and applicable regulatory requirements (e.g. written informed consent), shall be eligible to participate in the study (ISO 15197:2013 8.3).~3.2 Inclusion Criteria~Potential participants may be enrolled in the study if they satisfy the following inclusion criteria:~IC 1. Age of subject is 18 years or older IC 2. Has been diagnosed with Type1 or Type 2 diabetes IC 3. Able to speak and read English proficiently IC 4. Must be physically able to self-test~3.3 Exclusion Criteria Potential subjects who display any o"
11152297|NCT01889355|EG000|Reported Event|Adverse and Serious Events|No adverse or serious events occurred during this study
11152298|NCT01889563|BG000|Baseline|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
11152299|NCT01889563|BG001|Baseline|No Physical Exercise Training Program|No Physical Exercise Training Program
11152300|NCT01889563|BG002|Baseline|Total|Total of all reporting groups
11152301|NCT01889563|FG000|Participant Flow|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
11152302|NCT01889563|FG001|Participant Flow|No Physical Exercise Training Program|No Physical Exercise Training Program
11152303|NCT01889563|OG000|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
11152304|NCT01889563|OG001|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
11152305|NCT01889563|EG000|Reported Event|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
11152306|NCT01889563|EG001|Reported Event|No Physical Exercise Training Program|No Physical Exercise Training Program
11152307|NCT01889602|BG000|Baseline|Topiramate 100mg|"Randomized to Topiramate; 100mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments~Topiramate: Topiramate: 100 mg, 150 mg or 200 mg, po, 1x"
11152308|NCT01889602|BG001|Baseline|Topiramate 150mg|"Randomized to Topiramate; 150mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments~Lorazepam: Lorazepam: 2mg, po, 1x"
11152309|NCT01889602|BG002|Baseline|Topiramate 200mg|"Randomized to Topiramate; 200 mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments~Placebo"
11152310|NCT01889602|BG003|Baseline|Total|Total of all reporting groups
11152311|NCT01889602|FG000|Participant Flow|Topiramate 100mg|"Randomized to Topiramate; 100mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments~Topiramate: Topiramate: 100 mg, 150 mg or 200 mg, po, 1x"
11152312|NCT01889602|FG001|Participant Flow|Topiramate 150mg|"Randomized to Topiramate; 150mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments~Lorazepam: Lorazepam: 2mg, po, 1x"
11152313|NCT01889602|FG002|Participant Flow|Topiramate 200mg|"Randomized to Topiramate; 200 mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments~Placebo"
11152314|NCT01889602|OG000|Outcome|Arm: Topiramate 100mg, Period: Topiramate|"Randomized to Topiramate; 100mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the topiramate period.~Topiramate: 100 mg po, 1x"
11152315|NCT01889602|OG001|Outcome|Arm:Topiramate 150mg, Period: Topiramate|"Randomized to Topiramate; 150mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the topiramate period.~Topiramate: 150 mg po, 1x"
11152316|NCT01889602|OG002|Outcome|Arm: Topiramate 200mg, Period: Topiramate|"Randomized to Topiramate; 200mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the topiramate period.~Topiramate: 200 mg po, 1x"
11152317|NCT01889602|OG003|Outcome|Arm: Topiramate 100mg, Period: Lorazepam|"Randomized to Topiramate; 100mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the lorazepam period.~Lorazepam: 2 mg po, 1x"
11152318|NCT01889602|OG004|Outcome|Arm: Topiramate 150mg, Period: Lorazepam|"Randomized to Topiramate; 150mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the lorazepam period.~Lorazepam: 2 mg po, 1x"
11152319|NCT01889602|OG005|Outcome|Arm: Topiramate 200mg, Period: Lorazepam|"Randomized to Topiramate; 200mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the lorazepam period.~Lorazepam: 2 mg po, 1x"
11152320|NCT01889602|OG006|Outcome|Arm: Topiramate 100mg, Period: Placebo|"Randomized to Topiramate; 100mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the placebo period.~Placebo: po, 1x"
11152321|NCT01889602|OG007|Outcome|Arm: Topiramate 150mg, Period: Placebo|"Randomized to Topiramate; 150mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the placebo period.~Placebo: po, 1x"
11152322|NCT01889602|OG008|Outcome|Arm: Topiramate 200mg, Period: Placebo|"Randomized to Topiramate; 200mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments. This is the placebo period.~Placebo: po, 1x"
11152323|NCT01889602|EG000|Reported Event|Topiramate 100mg|Randomized to Topiramate; 100mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments
11152324|NCT01889602|EG001|Reported Event|Topiramate 150mg|Randomized to Topiramate; 150mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments
11152325|NCT01889602|EG002|Reported Event|Topiramate 200mg|Randomized to Topiramate; 200 mg; lorazepam 2mg or placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments
11152326|NCT01889602|EG003|Reported Event|Lorazepam 2mg|Randomized to Topiramate; 100, 150, or 200 mg; lorazepam 2mg; Each subject in this arm received each treatment in random order with a two-week washout between treatments
11152327|NCT01889602|EG004|Reported Event|Placebo|Randomized to Topiramate; 100, 150, or 200 mg; placebo; Each subject in this arm received each treatment in random order with a two-week washout between treatments
11152328|NCT01889667|BG000|Baseline|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
11152329|NCT01889667|BG001|Baseline|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
11152330|NCT01889667|BG002|Baseline|Placebo|"Oil Capsules~Placebo: Oil Capsules"
11152331|NCT01889667|BG003|Baseline|Total|Total of all reporting groups
11152332|NCT01889667|FG000|Participant Flow|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation"
11152333|NCT01889667|FG001|Participant Flow|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation"
11152334|NCT01889667|FG002|Participant Flow|Placebo|"Oil Capsules~Placebo: Oil Capsules"
11152335|NCT01889667|OG000|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation"
11152336|NCT01889667|OG001|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation"
11152337|NCT01889667|OG002|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
11152338|NCT01889667|OG000|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
11152339|NCT01889667|OG001|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
11152340|NCT01889667|EG000|Reported Event|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation (16 mg)"
11152341|NCT01889667|EG001|Reported Event|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation (24 mg)"
11152342|NCT01889667|EG002|Reported Event|Placebo|"Oil Capsules~Placebo: Oil Capsules"
11152343|NCT01889797|BG000|Baseline|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
11152344|NCT01889797|BG001|Baseline|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
11152345|NCT01889797|BG002|Baseline|Total|Total of all reporting groups
11152346|NCT01889797|FG000|Participant Flow|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
11152347|NCT01889797|FG001|Participant Flow|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
11152348|NCT01889797|OG000|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
11152349|NCT01889797|OG001|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
11152350|NCT01889797|EG000|Reported Event|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
11152351|NCT01889797|EG001|Reported Event|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
11152352|NCT01889862|BG000|Baseline|All Subjects|"BMN165 20mg/Day:~BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A.~BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.~Placebo 20mg/Day:~Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.~BMN165 40mg/Day:~BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A.~BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.~Placebo 40mg/Day:~Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.~BMN165:~Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4."
11152353|NCT01889862|FG000|Participant Flow|BMN165 20mg/Day|"BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A.~BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B."
11152354|NCT01889862|FG001|Participant Flow|Placebo 20mg/Day|Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.
11152355|NCT01889862|FG002|Participant Flow|BMN165 40mg/Day|"BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A.~BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B."
11152356|NCT01889862|FG003|Participant Flow|Placebo 40mg/Day|Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.
11152357|NCT01889862|FG004|Participant Flow|BMN165|Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
11152358|NCT01889862|OG000|Outcome|BMN165 20mg/Day|"BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A.~BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B."
11152359|NCT01889862|OG001|Outcome|Placebo 20mg/Day|Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.
11152360|NCT01889862|OG002|Outcome|BMN165 40mg/Day|"BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A.~BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B."
11152361|NCT01889862|OG003|Outcome|Placebo 40mg/Day|Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.
11152362|NCT01889862|OG000|Outcome|BMN165 < 20 mg/Day - Part 4|BMN165 < 20 mg/day subcutaneous injection administered using a prefilled syringe in Part 4.
11152363|NCT01889862|OG001|Outcome|BMN165 20 to < 40 mg/Day - Part 4|BMN165 < 20 mg/day subcutaneous injection administered using a prefilled syringe in Part 4.
11152364|NCT01889862|OG002|Outcome|BMN165 40 to < 60 mg/Day - Part 4|BMN165 40 to < 60 mg/day subcutaneous injection administered using a prefilled syringe in Part 4.
11152365|NCT01889862|OG003|Outcome|BMN165 >= 60 mg/Day - Part 4|BMN165 >= 60 mg/day subcutaneous injection administered using a prefilled syringe in Part 4.
11152366|NCT01889862|OG004|Outcome|BMN165 All Dose - Part 4|Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
11152367|NCT01889862|EG000|Reported Event|Part 1 - 20 mg/Day|BMN165 20mg/day subcutaneous injection administered using vial and syringe.
11152368|NCT01889862|EG001|Reported Event|Part 1 - 40 mg/Day|BMN165 40mg/day subcutaneous injection administered using vial and syringe.
11152369|NCT01889862|EG002|Reported Event|Part 2 - 20 mg/Day Active|BMN165 20mg/day subcutaneous injection administered using vial and syringe.
11152370|NCT01889862|EG003|Reported Event|Part 2 - 40 mg/Day Active|BMN165 40mg/day subcutaneous injection administered using vial and syringe.
11152371|NCT01889862|EG004|Reported Event|Part 2 - 20 mg/Day Placebo|Matching placebo 20mg/day subcutaneous injection administered using vial and syringe.
11152372|NCT01889862|EG005|Reported Event|Part 2 - 40 mg/Day Placebo|Matching placebo 40mg/day subcutaneous injection administered using vial and syringe.
11152373|NCT01889862|EG006|Reported Event|Part 3 - Stay on Active 20 mg/Day|"BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 3A.~BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B."
11152374|NCT01889862|EG007|Reported Event|Part 3 - Stay on Active 40 mg/Day|"BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 3A.~BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B."
10851396|NCT00306202|OG006|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
11152375|NCT01889862|EG008|Reported Event|Part 3 - Switch From Placebo to Active 20 mg/Day|"BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 3A.~BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B."
11152376|NCT01889862|EG009|Reported Event|Part 3 - Switch From Placebo to Active 40 mg/Day|"BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 3A.~BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B."
11152377|NCT01889862|EG010|Reported Event|Part 4 - < 20 mg/Day|BMN165 <20mg/day subcutaneous injection administered using a prefilled syringe.
11152378|NCT01889862|EG011|Reported Event|Part 4 - 20 to < 40 mg/Day|BMN165 20 to <40mg/day subcutaneous injection administered using a prefilled syringe.
11152379|NCT01889862|EG012|Reported Event|Part 4 - 40 to < 60 mg/Day|BMN165 40 to <60mg/day subcutaneous injection administered using a prefilled syringe.
11152380|NCT01889862|EG013|Reported Event|Part 4 - >= 60 mg/Day|BMN165 >=60mg/day subcutaneous injection administered using a prefilled syringe.
11152381|NCT01890031|BG000|Baseline|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
11152382|NCT01890031|BG001|Baseline|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
11152383|NCT01890031|BG002|Baseline|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
11152384|NCT01890031|BG003|Baseline|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
11152385|NCT01890031|BG004|Baseline|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
11152386|NCT01890031|BG005|Baseline|Total|Total of all reporting groups
11152387|NCT01890031|FG000|Participant Flow|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
11152388|NCT01890031|FG001|Participant Flow|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
11152389|NCT01890031|FG002|Participant Flow|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
11152390|NCT01890031|FG003|Participant Flow|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
11152391|NCT01890031|FG004|Participant Flow|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
11152392|NCT01890031|OG000|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
11152393|NCT01890031|OG001|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
11152394|NCT01890031|OG002|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
11152395|NCT01890031|OG003|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
11152396|NCT01890031|OG004|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
11152397|NCT01890031|EG000|Reported Event|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
11152398|NCT01890031|EG001|Reported Event|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
11152399|NCT01890031|EG002|Reported Event|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
11152400|NCT01890031|EG003|Reported Event|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
11152401|NCT01890031|EG004|Reported Event|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
11152402|NCT01890109|BG000|Baseline|Placebo|Participants received a single dose of placebo administered by subcutaneous injection.
11152403|NCT01890109|BG001|Baseline|Erenumab|Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.
11152404|NCT01890109|BG002|Baseline|Total|Total of all reporting groups
11152405|NCT01890109|FG000|Participant Flow|Placebo|Participants received a single dose of placebo administered by subcutaneous injection.
11152406|NCT01890109|FG001|Participant Flow|Erenumab|Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.
11152407|NCT01890109|OG000|Outcome|Placebo|Participants received a single dose of placebo administered by subcutaneous injection.
11152408|NCT01890109|OG001|Outcome|Erenumab|Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.
11152409|NCT01890109|OG000|Outcome|Erenumab|Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.
11152410|NCT01890109|EG000|Reported Event|Placebo|Participants received a single dose of placebo administered by subcutaneous injection.
11152411|NCT01890109|EG001|Reported Event|Erenumab 70 mg|Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.
11152412|NCT01890122|BG000|Baseline|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
11152413|NCT01890122|BG001|Baseline|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
11152414|NCT01890122|BG002|Baseline|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
11152415|NCT01890122|BG003|Baseline|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
11152416|NCT01890122|BG004|Baseline|Total|Total of all reporting groups
11152417|NCT01890122|FG000|Participant Flow|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
11152418|NCT01890122|FG001|Participant Flow|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
11152419|NCT01890122|FG002|Participant Flow|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
11152420|NCT01890122|FG003|Participant Flow|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
11152421|NCT01890122|OG000|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
11152422|NCT01890122|OG001|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
11152423|NCT01890122|OG002|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
11152424|NCT01890122|OG003|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
11152425|NCT01890122|EG000|Reported Event|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
11152426|NCT01890122|EG001|Reported Event|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
11152427|NCT01890122|EG002|Reported Event|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
11152428|NCT01890122|EG003|Reported Event|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
11152429|NCT01890148|BG000|Baseline|AZD5069|AZD5069 45mg oral twice daily (BID)
11152430|NCT01890148|FG000|Participant Flow|AZD5069|AZD5069 45mg oral twice daily (BID)
11152431|NCT01890148|OG000|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
11152432|NCT01890148|EG000|Reported Event|AZD5069|AZD5069 45mg oral twice daily (BID)
11152433|NCT01890226|BG000|Baseline|Control|Control or usual care group: had access to the full array of services offered through the behavioral health homes.
11152434|NCT01890226|BG001|Baseline|Experimental: Intervention|"Participants randomized to the intervention arm will receive the mobile personal health record.~Mobile Personal Health Record App."
11152435|NCT01890226|BG002|Baseline|Total|Total of all reporting groups
11152436|NCT01890226|FG000|Participant Flow|Control|Control or usual care group: had access to the full array o services offered through the behavioral health homes.
11152437|NCT01890226|FG001|Participant Flow|Experimental: Intervention|"Participants randomized to the intervention arm will receive the mobile personal health record.~Mobile Personal Health Record App."
11152438|NCT01890226|OG000|Outcome|Control|Control or usual care group: had access to the full array o services offered through the behavioral health homes.
11152439|NCT01890226|OG001|Outcome|Experimental: Intervention|"Participants randomized to the intervention arm will receive the mobile personal health record.~Mobile Personal Health Record App."
11152440|NCT01890226|EG000|Reported Event|Control|Control or usual care group: had access to the full array of services offered through the behavioral health homes.
11152441|NCT01890226|EG001|Reported Event|Experimental: Intervention|"Participants randomized to the intervention arm will receive the mobile personal health record.~Mobile Personal Health Record App."
11152442|NCT01890265|BG000|Baseline|Pamrevlumab|Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
11152443|NCT01890265|BG001|Baseline|Placebo|Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
11152444|NCT01890265|BG002|Baseline|Sub-Study: Pamrevlumab+Pirfenidone|"Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Pirfenidone was dosed according to the instructions in the label and the prescribing physician."
11152445|NCT01890265|BG003|Baseline|Sub-Study:Placebo+Pirfenidone|"Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Pirfenidone was dosed according to the instructions in the label and the prescribing physician."
11152446|NCT01890265|BG004|Baseline|Sub-Study:Pamrevlumab+Nintedanib|"Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Nintedanib was dosed according to the instructions in the label and the prescribing physician."
11152447|NCT01890265|BG005|Baseline|Sub-Study: Placebo+Nintedanib|"Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Nintedanib was dosed according to the instructions in the label and the prescribing physician."
11152448|NCT01890265|BG006|Baseline|Total|Total of all reporting groups
11152449|NCT01890265|FG000|Participant Flow|Pamrevlumab|Participants received pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks.
11152450|NCT01890265|FG001|Participant Flow|Placebo|Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
11152451|NCT01890265|FG002|Participant Flow|Sub-Study: Pamrevlumab+Pirfenidone|"Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Pirfenidone was dosed according to the instructions in the label and the prescribing physician."
11152452|NCT01890265|FG003|Participant Flow|Sub-Study: Placebo+Pirfenidone|"Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Pirfenidone was dosed according to the instructions in the label and the prescribing physician."
11152453|NCT01890265|FG004|Participant Flow|Sub-Study: Pamrevlumab+Nintedanib|"Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Nintedanib was dosed according to the instructions in the label and the prescribing physician."
11152454|NCT01890265|FG005|Participant Flow|Sub-Study: Placebo+Nintedanib|"Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Nintedanib was dosed according to the instructions in the label and the prescribing physician."
11152455|NCT01890265|OG000|Outcome|Pamrevlumab|Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
11152456|NCT01890265|OG001|Outcome|Placebo|Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
11152457|NCT01890265|EG000|Reported Event|Pamrevlumab|Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
11152458|NCT01890265|EG001|Reported Event|Placebo|Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
11152459|NCT01890265|EG002|Reported Event|Sub-Study: Pamrevlumab+Pirfenidone|"Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Pirfenidone was dosed according to the instructions in the label and the prescribing physician."
11152460|NCT01890265|EG003|Reported Event|Sub-Study: Placebo+Pirfenidone|"Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Pirfenidone was dosed according to the instructions in the label and the prescribing physician."
11152461|NCT01890265|EG004|Reported Event|Sub-Study: Pamrevlumab+Nintedanib|"Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Nintedanib was dosed according to the instructions in the label and the prescribing physician."
11152462|NCT01890265|EG005|Reported Event|Sub-Study: Placebo+Nintedanib|"Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg.~Nintedanib was dosed according to the instructions in the label and the prescribing physician."
11152463|NCT01890343|BG000|Baseline|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
11152464|NCT01890343|BG001|Baseline|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
11152465|NCT01890343|BG002|Baseline|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
11152466|NCT01890343|BG003|Baseline|Total|Total of all reporting groups
11152467|NCT01890343|FG000|Participant Flow|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
11152468|NCT01890343|FG001|Participant Flow|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
11152469|NCT01890343|FG002|Participant Flow|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
11152470|NCT01890343|OG000|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
11152471|NCT01890343|OG001|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
11152472|NCT01890343|OG002|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
11152473|NCT01890343|EG000|Reported Event|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
11152474|NCT01890343|EG001|Reported Event|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
11152475|NCT01890343|EG002|Reported Event|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
11152476|NCT01890421|BG000|Baseline|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
11152477|NCT01890421|FG000|Participant Flow|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
11152478|NCT01890421|OG000|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
11152479|NCT01890421|EG000|Reported Event|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
11152480|NCT01890434|BG000|Baseline|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
11152481|NCT01890434|FG000|Participant Flow|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
11152482|NCT01890434|OG000|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
11152483|NCT01890434|EG000|Reported Event|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 mmol/kg BW in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
11152484|NCT01890473|BG000|Baseline|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
11152485|NCT01890473|BG001|Baseline|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
11152486|NCT01890473|BG002|Baseline|Total|Total of all reporting groups
11152487|NCT01890473|FG000|Participant Flow|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
11152488|NCT01890473|FG001|Participant Flow|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
11152489|NCT01890473|OG000|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
11152490|NCT01890473|OG001|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
11152491|NCT01890473|OG000|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
11152492|NCT01890473|OG001|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
11152493|NCT01890473|EG000|Reported Event|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
11152494|NCT01890473|EG001|Reported Event|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a PFS.
11152495|NCT01890512|BG000|Baseline|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
11152496|NCT01890512|FG000|Participant Flow|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
11152497|NCT01890512|OG000|Outcome|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
11152498|NCT01890512|EG000|Reported Event|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
11152499|NCT01890642|BG000|Baseline|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
11152500|NCT01890642|BG001|Baseline|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
11152501|NCT01890642|BG002|Baseline|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
11152502|NCT01890642|BG003|Baseline|Total|Total of all reporting groups
11152503|NCT01890642|FG000|Participant Flow|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
11152504|NCT01890642|FG001|Participant Flow|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
11152505|NCT01890642|FG002|Participant Flow|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
11152506|NCT01890642|OG000|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
11152507|NCT01890642|OG001|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
11152508|NCT01890642|OG002|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
11152509|NCT01890642|EG000|Reported Event|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
11152510|NCT01890642|EG001|Reported Event|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
11152511|NCT01890642|EG002|Reported Event|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
11152512|NCT01890707|BG000|Baseline|Deep Sedation|"Deep sedation~Deep Sedation: IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement."
11152513|NCT01890707|BG001|Baseline|General Anesthesia|"Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.~General Anesthesia: Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60."
11152514|NCT01890707|BG002|Baseline|Total|Total of all reporting groups
11152515|NCT01890707|FG000|Participant Flow|Deep Sedation|"Deep sedation~Deep Sedation: IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement."
11152516|NCT01890707|FG001|Participant Flow|General Anesthesia|"Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.~General Anesthesia: Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60."
11152517|NCT01890707|OG000|Outcome|Deep Sedation|"Deep sedation~Deep Sedation: IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement."
11152518|NCT01890707|OG001|Outcome|General Anesthesia|"Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.~General Anesthesia: Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60."
11152519|NCT01890707|EG000|Reported Event|Deep Sedation|"Deep sedation~Deep Sedation: IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement."
11152520|NCT01890707|EG001|Reported Event|General Anesthesia|"Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.~General Anesthesia: Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60."
11152521|NCT01890746|BG000|Baseline|Eltrombopag (ELQ) QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
11152522|NCT01890746|BG001|Baseline|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
11152523|NCT01890746|BG002|Baseline|Total|Total of all reporting groups
11152524|NCT01890746|FG000|Participant Flow|Eltrombopag (ELQ) QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
10887701|NCT00502593|BG000|Baseline|GSK1562902A -A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887702|NCT00502593|BG001|Baseline|Fluarix-A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11152525|NCT01890746|FG001|Participant Flow|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
11152526|NCT01890746|OG000|Outcome|Eltrombopag (ELQ) QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
11152527|NCT01890746|OG001|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
11152528|NCT01890746|EG000|Reported Event|Eltrombopag (ELQ) QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
11152529|NCT01890746|EG001|Reported Event|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
11152530|NCT01890785|BG000|Baseline|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
11152531|NCT01890785|BG001|Baseline|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
11152532|NCT01890785|BG002|Baseline|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
11152533|NCT01890785|BG003|Baseline|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
11152534|NCT01890785|BG004|Baseline|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
11152535|NCT01890785|BG005|Baseline|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
11152536|NCT01890785|BG006|Baseline|Total|Total of all reporting groups
11152537|NCT01890785|FG000|Participant Flow|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
11152538|NCT01890785|FG001|Participant Flow|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
11152539|NCT01890785|FG002|Participant Flow|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
11152540|NCT01890785|FG003|Participant Flow|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
11152541|NCT01890785|FG004|Participant Flow|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
11152542|NCT01890785|FG005|Participant Flow|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
11152543|NCT01890785|OG000|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
11152544|NCT01890785|OG001|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
11152545|NCT01890785|OG002|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
11152546|NCT01890785|OG002|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
11152547|NCT01890785|EG000|Reported Event|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
11152548|NCT01890785|EG001|Reported Event|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt(Single dose of a 70 mg capsule on Day 1)
11152549|NCT01890785|EG002|Reported Event|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
11152550|NCT01890915|BG000|Baseline|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
11152551|NCT01890915|BG001|Baseline|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
11152552|NCT01890915|BG002|Baseline|Total|Total of all reporting groups
11152553|NCT01890915|FG000|Participant Flow|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
11152554|NCT01890915|FG001|Participant Flow|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
11152555|NCT01890915|OG000|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
11152556|NCT01890915|OG001|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
11152557|NCT01890915|EG000|Reported Event|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
11152558|NCT01890915|EG001|Reported Event|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
11152559|NCT01890954|BG000|Baseline|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
11152560|NCT01890954|BG001|Baseline|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
11152561|NCT01890954|BG002|Baseline|Total|Total of all reporting groups
11152562|NCT01890954|FG000|Participant Flow|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
11152563|NCT01890954|FG001|Participant Flow|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
11152564|NCT01890954|OG000|Outcome|Closed Loop Control With DiAs System|8 hours observational (09:00-17:00) during closed-loop control (DiAs) with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
11152565|NCT01890954|OG001|Outcome|Usual Care Without DiAs System (CGM Only)|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
11152566|NCT01890954|EG000|Reported Event|Closed Loop Control With DiAs System|"8 hours using Closed Loop Control with DiAs under both, miss insulin bolus for 30 grams of carbohydrates snack or under bolus for an 80 grams of carbohydrates lunch~Diabetes Assistant (DiAs)"
11152567|NCT01890954|EG001|Reported Event|Usual Care Without DiAs System (CGM Only)|8 hours observational under both, missed insulin bolus for 30 gr carbohydrates snack and under bolus for an 80 gr carbohydrates lunch.
11152568|NCT01890967|BG000|Baseline|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152569|NCT01890967|BG001|Baseline|20 mg LY3015014 Q4W|"20 mg LY3015014 given subcutaneously SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152570|NCT01890967|BG002|Baseline|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152571|NCT01890967|BG003|Baseline|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152572|NCT01890967|BG004|Baseline|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152573|NCT01890967|BG005|Baseline|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152574|NCT01890967|BG006|Baseline|Total|Total of all reporting groups
11152575|NCT01890967|FG000|Participant Flow|Placebo Q4W|"Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152576|NCT01890967|FG001|Participant Flow|20 mg LY3015014 Q4W|"20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152577|NCT01890967|FG002|Participant Flow|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152578|NCT01890967|FG003|Participant Flow|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152579|NCT01890967|FG004|Participant Flow|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152580|NCT01890967|FG005|Participant Flow|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152581|NCT01890967|OG000|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152582|NCT01890967|OG001|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152583|NCT01890967|OG002|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152584|NCT01890967|OG003|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152585|NCT01890967|OG004|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152586|NCT01890967|OG005|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152587|NCT01890967|OG000|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152588|NCT01890967|OG001|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152589|NCT01890967|OG002|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152590|NCT01890967|OG003|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152591|NCT01890967|OG004|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152592|NCT01890967|EG000|Reported Event|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152593|NCT01890967|EG001|Reported Event|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152594|NCT01890967|EG002|Reported Event|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152595|NCT01890967|EG003|Reported Event|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152596|NCT01890967|EG004|Reported Event|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152597|NCT01890967|EG005|Reported Event|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
11152598|NCT01891305|BG000|Baseline|VT-1161 200/50mg|
11152599|NCT01891305|BG001|Baseline|VT-1161 600/150mg|
11152600|NCT01891305|BG002|Baseline|VT-1161 1200/300mg|
11152601|NCT01891305|BG003|Baseline|Matching Placebo|
11152602|NCT01891305|BG004|Baseline|Total|Total of all reporting groups
11152603|NCT01891305|FG000|Participant Flow|VT-1161 200/50mg|VT-1161 200mg once daily for 4 days, then VT-1161 50mg once daily for 10 days
11152604|NCT01891305|FG001|Participant Flow|VT-1161 600/150mg|VT-1161 600mg once daily for 4 days, then VT-1161 150mg once daily for 10 days
11152605|NCT01891305|FG002|Participant Flow|VT-1161 1200/300mg|VT-1161 1200mg once daily for 4 days, then VT-1161 300mg once daily for 10 days
11152606|NCT01891305|FG003|Participant Flow|Placebo|matching tablets over-encapsulated for blinding purposes
11152607|NCT01891305|OG000|Outcome|VT-1161 200/50mg|
11152608|NCT01891305|OG001|Outcome|VT-1161 600/150mg|
11152609|NCT01891305|OG002|Outcome|VT-1161 1200/300mg|
11152610|NCT01891305|OG003|Outcome|Matching Placebo|
11152611|NCT01891305|EG000|Reported Event|VT-1161 200/50mg|
11152612|NCT01891305|EG001|Reported Event|VT-1161 600/150mg|
11152613|NCT01891305|EG002|Reported Event|VT-1161 1200/300mg|
11152614|NCT01891305|EG003|Reported Event|Matching Placebo|
11152615|NCT01891331|BG000|Baseline|VT-1161 300mg QD|
11152616|NCT01891331|BG001|Baseline|VT-1161 600mg QD|
11152617|NCT01891331|BG002|Baseline|VT-1161 600mg BID|
11152618|NCT01891331|BG003|Baseline|Fluconazole 150mg|
11152619|NCT01891331|BG004|Baseline|Total|Total of all reporting groups
11152620|NCT01891331|FG000|Participant Flow|VT-1161 300mg QD|VT-1161 300mg once daily for 3 days
11152621|NCT01891331|FG001|Participant Flow|VT-1161 600mg QD|VT-1161 600mg once daily for 3 days
11152622|NCT01891331|FG002|Participant Flow|VT-1161 600mg BID|VT-1161 600mg twice daily for 3 days
11152623|NCT01891331|FG003|Participant Flow|Fluconazole 150mg|Single dose of fluconazole 150mg
11152624|NCT01891331|OG000|Outcome|VT-1161 300mg QD|
11152625|NCT01891331|OG001|Outcome|VT-1161 600mg QD|
11152626|NCT01891331|OG002|Outcome|VT-1161 600mg BID|
11152627|NCT01891331|OG003|Outcome|Fluconazole 150mg|
11152628|NCT01891331|EG000|Reported Event|VT-1161 300mg QD|
10887703|NCT00502593|BG002|Baseline|GSK1562902A-A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11089082|NCT01521871|BG001|Baseline|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
11089083|NCT01521871|BG002|Baseline|Total|Total of all reporting groups
11089084|NCT01521871|FG000|Participant Flow|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
11089085|NCT01521871|FG001|Participant Flow|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
11089086|NCT01521871|OG000|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
11089087|NCT01521871|OG001|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
11089088|NCT01521871|EG000|Reported Event|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
11089089|NCT01521871|EG001|Reported Event|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
11089090|NCT01521884|BG000|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
11152629|NCT01891331|EG001|Reported Event|VT-1161 600mg QD|
11152630|NCT01891331|EG002|Reported Event|VT-1161 600mg BID|
11152631|NCT01891331|EG003|Reported Event|Fluconazole 150mg|
11152632|NCT01891357|BG000|Baseline|Paclitaxel + Lapatinib + Trastuzumab|"Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment~Biopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology~paclitaxel~lapatinib~trastuzumab"
11152633|NCT01891357|FG000|Participant Flow|Paclitaxel + Lapatinib + Trastuzumab|"Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment~Biopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology~paclitaxel~lapatinib~trastuzumab"
11152634|NCT01891357|OG000|Outcome|Paclitaxel + Lapatinib + Trastuzumab|"Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment~Biopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology~paclitaxel~lapatinib~trastuzumab"
11152635|NCT01891357|EG000|Reported Event|Paclitaxel + Lapatinib + Trastuzumab|"Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment~Biopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology~paclitaxel~lapatinib~trastuzumab"
11152636|NCT01891669|BG000|Baseline|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152637|NCT01891669|BG001|Baseline|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152638|NCT01891669|BG002|Baseline|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152639|NCT01891669|BG003|Baseline|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152640|NCT01891669|BG004|Baseline|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152641|NCT01891669|BG005|Baseline|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152642|NCT01891669|BG006|Baseline|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152643|NCT01891669|BG007|Baseline|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152644|NCT01891669|BG008|Baseline|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152645|NCT01891669|BG009|Baseline|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152646|NCT01891669|BG010|Baseline|Total|Total of all reporting groups
11152647|NCT01891669|FG000|Participant Flow|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152648|NCT01891669|FG001|Participant Flow|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152649|NCT01891669|FG002|Participant Flow|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152650|NCT01891669|FG003|Participant Flow|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152651|NCT01891669|FG004|Participant Flow|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152652|NCT01891669|FG005|Participant Flow|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152653|NCT01891669|FG006|Participant Flow|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152654|NCT01891669|FG007|Participant Flow|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152655|NCT01891669|FG008|Participant Flow|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152656|NCT01891669|FG009|Participant Flow|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152657|NCT01891669|OG000|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152658|NCT01891669|OG001|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152659|NCT01891669|OG002|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152660|NCT01891669|OG003|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152661|NCT01891669|OG004|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152662|NCT01891669|OG005|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152663|NCT01891669|OG006|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152664|NCT01891669|OG007|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152665|NCT01891669|OG008|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152666|NCT01891669|OG009|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152667|NCT01891669|OG000|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152668|NCT01891669|OG001|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152669|NCT01891669|OG002|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152670|NCT01891669|OG003|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152671|NCT01891669|OG004|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152672|NCT01891669|OG005|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152673|NCT01891669|OG006|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152674|NCT01891669|OG007|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152675|NCT01891669|OG008|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152676|NCT01891669|EG000|Reported Event|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152677|NCT01891669|EG001|Reported Event|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152678|NCT01891669|EG002|Reported Event|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152679|NCT01891669|EG003|Reported Event|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152680|NCT01891669|EG004|Reported Event|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152681|NCT01891669|EG005|Reported Event|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152682|NCT01891669|EG006|Reported Event|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152683|NCT01891669|EG007|Reported Event|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152684|NCT01891669|EG008|Reported Event|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152685|NCT01891669|EG009|Reported Event|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
11152686|NCT01891721|BG000|Baseline|Specific Perceptual Training - Brain Fitness Program (BFP)|"In each session, participants worked on 4 of the 6 BFP exercises (15 min per exercise). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Brain Fitness Program (BFP): This computerized bottom-up cognitive intervention is designed to improve the speed and accuracy of auditory information processing through increasingly more difficult stimulus recognition, discrimination, sequencing, and memory tasks under conditions of close attentional control, high reward, and novelty. BFP consists of 6 exercises. Stimuli across the exercises are chosen such that they span the acoustic and organizational structure of speech, from very simple acoustic stimuli and tasks to complex manipulations of continuous speech. The exercises adaptively progress based on the subject's individual performance during a training session and become more challenging as the subject's abilities improve."
11152687|NCT01891721|BG001|Baseline|Broad Cognitive Training - Cognitive Package (Cogpack)|"In each session, participants worked on a different subset of 4 to 6 Cogpack exercises. Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Cognitive Package (Cogpack): This computerized top-down cognitive intervention is designed to provide training across a broad range of cognitive functions. Cogpack consists of domain-specific exercises aimed at training specific cognitive areas (attention, working memory, verbal and visual memory, executive functioning, reasoning, language) and non-domain-specific exercises that require the use of several functions at a time. Cogpack includes low-level cognitive exercises (i.e., scanning, hand-eye coordination, psychomotor speed) that were not included in this protocol to better separate bottom-up from top-down training interventions. There was a total of 34 exercises and variants of the same exercises with different levels of difficulty."
11152688|NCT01891721|BG002|Baseline|Control Treatment - Commercial Computer Games (Sporcle)|"In each session, participants played between 8 and 16 games (1 to 15 min per game). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Commercial Computer Games (Sporcle): Sporcle computer games were used as a placebo treatment to control for the effects of computer exposure, contact with research personnel, time spent being cognitively active, and financial compensation for participation. The games cover trivia-type questions about geography, entertainment, science, history, literature, sports, movies, etc. Subjects received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of training per week over 12 weeks, for a total of 36 hours."
11152689|NCT01891721|BG003|Baseline|Total|Total of all reporting groups
11152690|NCT01891721|FG000|Participant Flow|Specific Perceptual Training - Brain Fitness Program (BFP)|"In each session, participants worked on 4 of the 6 BFP exercises (15 min per exercise). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Brain Fitness Program (BFP): This computerized bottom-up cognitive intervention is designed to improve the speed and accuracy of auditory information processing through increasingly more difficult stimulus recognition, discrimination, sequencing, and memory tasks under conditions of close attentional control, high reward, and novelty. BFP consists of 6 exercises. Stimuli across the exercises are chosen such that they span the acoustic and organizational structure of speech, from very simple acoustic stimuli and tasks to complex manipulations of continuous speech. The exercises adaptively progress based on the subject's individual performance during a training session and become more challenging as the subject's abilities improve."
11228065|NCT02388165|EG000|Reported Event|Staphylococcus Aureus 4-antigen (SA4Ag)|Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
11152691|NCT01891721|FG001|Participant Flow|Broad Cognitive Training - Cognitive Package (Cogpack)|"In each session, participants worked on a different subset of 4 to 6 Cogpack exercises. Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Cognitive Package (Cogpack): This computerized top-down cognitive intervention is designed to provide training across a broad range of cognitive functions. Cogpack consists of domain-specific exercises aimed at training specific cognitive areas (attention, working memory, verbal and visual memory, executive functioning, reasoning, language) and non-domain-specific exercises that require the use of several functions at a time. Cogpack includes low-level cognitive exercises (i.e., scanning, hand-eye coordination, psychomotor speed) that will not be included in this protocol to better separate bottom-up from top-down training interventions. There will be a total of 34 exercises and variants of the same exercises with different levels of difficulty."
11152692|NCT01891721|FG002|Participant Flow|Control Treatment - Commercial Computer Games (Sporcle)|"In each session, participants played between 8 and 16 games (1 to 15 min per game). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Commercial Computer Games (Sporcle): Sporcle computer games were used as a placebo treatment to control for the effects of computer exposure, contact with research personnel, time spent being cognitively active, and financial compensation for participation. The games cover trivia-type questions about geography, entertainment, science, history, literature, sports, movies, etc. Subjects received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of training per week over 12 weeks, for a total of 36 hours."
11152693|NCT01891721|OG000|Outcome|Specific Auditory Training - Brain Fitness Program (BFP)|"In each session, participants worked on 4 of the 6 BFP exercises (15 min per exercise). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Brain Fitness Program (BFP): This computerized bottom-up cognitive intervention is designed to improve the speed and accuracy of auditory information processing through increasingly more difficult stimulus recognition, discrimination, sequencing, and memory tasks under conditions of close attentional control, high reward, and novelty. BFP consists of 6 exercises. Stimuli across the exercises are chosen such that they span the acoustic and organizational structure of speech, from very simple acoustic stimuli and tasks to complex manipulations of continuous speech. The exercises adaptively progress based on the subject's individual performance during a training session and become more challenging as the subject's abilities improve."
11152694|NCT01891721|OG001|Outcome|Broad Cognitive Training - Cognitive Package (Cogpack)|"In each session, participants worked on a different subset of 4 to 6 Cogpack exercises. Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Cognitive Package (Cogpack): This computerized top-down cognitive intervention is designed to provide training across a broad range of cognitive functions. Cogpack consists of domain-specific exercises aimed at training specific cognitive areas (attention, working memory, verbal and visual memory, executive functioning, reasoning, language) and non-domain-specific exercises that require the use of several functions at a time. Cogpack includes low-level cognitive exercises (i.e., scanning, hand-eye coordination, psychomotor speed) that were not included in this protocol to better separate bottom-up from top-down training interventions. There was a total of 34 exercises and variants of the same exercises with different levels of difficulty."
11152695|NCT01891721|OG002|Outcome|Control Treatment - Commercial Computer Games (Sporcle)|"In each session, participants played between 8 and 16 games (1 to 15 min per game). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Commercial Computer Games (Sporcle): Sporcle computer games were used as a placebo treatment to control for the effects of computer exposure, contact with research personnel, time spent being cognitively active, and financial compensation for participation. The games cover trivia-type questions about geography, entertainment, science, history, literature, sports, movies, etc. Subjects received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of training per week over 12 weeks, for a total of 36 hours."
11152696|NCT01891721|EG000|Reported Event|Specific Perceptual Training - Brain Fitness Program (BFP)|"In each session, participants worked on 4 of the 6 BFP exercises (15 min per exercise). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Brain Fitness Program (BFP): This computerized bottom-up cognitive intervention is designed to improve the speed and accuracy of auditory information processing through increasingly more difficult stimulus recognition, discrimination, sequencing, and memory tasks under conditions of close attentional control, high reward, and novelty. BFP consists of 6 exercises. Stimuli across the exercises are chosen such that they span the acoustic and organizational structure of speech, from very simple acoustic stimuli and tasks to complex manipulations of continuous speech. The exercises adaptively progress based on the subject's individual performance during a training session and become more challenging as the subject's abilities improve."
11152697|NCT01891721|EG001|Reported Event|Broad Cognitive Training - Cognitive Package (Cogpack)|"In each session, participants worked on a different subset of 4 to 6 Cogpack exercises. Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Cognitive Package (Cogpack): This computerized top-down cognitive intervention is designed to provide training across a broad range of cognitive functions. Cogpack consists of domain-specific exercises aimed at training specific cognitive areas (attention, working memory, verbal and visual memory, executive functioning, reasoning, language) and non-domain-specific exercises that require the use of several functions at a time. Cogpack includes low-level cognitive exercises (i.e., scanning, hand-eye coordination, psychomotor speed) that were not included in this protocol to better separate bottom-up from top-down training interventions. There was a total of 34 exercises and variants of the same exercises with different levels of difficulty."
11228066|NCT02388165|EG001|Reported Event|Placebo|Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
11228067|NCT02388191|BG000|Baseline|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
11228068|NCT02388191|BG001|Baseline|Placebo|"Placebo~Placebo tablet"
11228069|NCT02388191|BG002|Baseline|Total|Total of all reporting groups
11152698|NCT01891721|EG002|Reported Event|Control Treatment - Commercial Computer Games (Sporcle)|"In each session, participants played between 8 and 16 games (1 to 15 min per game). Duration of training is 1 hour per day, 3 days per week, for 12 weeks, for a total of 36 hours.~Commercial Computer Games (Sporcle): Sporcle computer games were used as a placebo treatment to control for the effects of computer exposure, contact with research personnel, time spent being cognitively active, and financial compensation for participation. The games cover trivia-type questions about geography, entertainment, science, history, literature, sports, movies, etc. Subjects received the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They also completed 3 hours of training per week over 12 weeks, for a total of 36 hours."
11152699|NCT01891734|BG000|Baseline|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
11152700|NCT01891734|BG001|Baseline|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
11152701|NCT01891734|BG002|Baseline|Total|Total of all reporting groups
11152702|NCT01891734|FG000|Participant Flow|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
11152703|NCT01891734|FG001|Participant Flow|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
11152704|NCT01891734|OG000|Outcome|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
11152705|NCT01891734|OG001|Outcome|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
11152706|NCT01891734|OG000|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
11152707|NCT01891734|OG001|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
10887704|NCT00502593|BG003|Baseline|Fluarix-A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11152708|NCT01891734|EG000|Reported Event|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
11152709|NCT01891734|EG001|Reported Event|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
11152710|NCT01891864|BG000|Baseline|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
11152711|NCT01891864|BG001|Baseline|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
11152712|NCT01891864|BG002|Baseline|Total|Total of all reporting groups
11152713|NCT01891864|FG000|Participant Flow|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
11152714|NCT01891864|FG001|Participant Flow|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
11152715|NCT01891864|FG002|Participant Flow|GP2015 Etanercept Continued|"GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2"
11152716|NCT01891864|FG003|Participant Flow|Enbrel ® Etanercept Continued|Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2) Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.
11152717|NCT01891864|FG004|Participant Flow|GP2015 Etanercept Switched|"GP2015/Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152718|NCT01891864|FG005|Participant Flow|Enbrel ® Etanercept Switched|"Enbrel ®/GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152719|NCT01891864|OG000|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
11152720|NCT01891864|OG001|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
11152721|NCT01891864|OG000|Outcome|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152722|NCT01891864|OG001|Outcome|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152723|NCT01891864|OG002|Outcome|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152724|NCT01891864|OG003|Outcome|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11228070|NCT02388191|FG000|Participant Flow|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
11228071|NCT02388191|FG001|Participant Flow|Placebo|"Placebo~Placebo tablet"
11152725|NCT01891864|EG000|Reported Event|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152726|NCT01891864|EG001|Reported Event|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152727|NCT01891864|EG002|Reported Event|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152728|NCT01891864|EG003|Reported Event|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
11152729|NCT01891890|BG000|Baseline|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
11152730|NCT01891890|BG001|Baseline|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
11152731|NCT01891890|BG002|Baseline|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
11152732|NCT01891890|BG003|Baseline|Total|Total of all reporting groups
11152733|NCT01891890|FG000|Participant Flow|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
11152734|NCT01891890|FG001|Participant Flow|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
11152735|NCT01891890|FG002|Participant Flow|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
11152736|NCT01891890|OG000|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
11152737|NCT01891890|OG001|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
11152738|NCT01891890|OG002|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
11152739|NCT01891890|EG000|Reported Event|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
11152740|NCT01891890|EG001|Reported Event|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
11152741|NCT01891890|EG002|Reported Event|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
11152742|NCT01891968|BG000|Baseline|Bortezomib|Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
11152743|NCT01891968|FG000|Participant Flow|Bortezomib|Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
11152744|NCT01891968|OG000|Outcome|Bortezomib|Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
11152745|NCT01891968|EG000|Reported Event|Bortezomib|Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
11152746|NCT01892007|BG000|Baseline|Cogmed RM (Adaptive)|"Online training intervention: An adaptive version of Cogmed RM working memory training. Task difficulty (number of to-be-remembered items) increases based on individual performance, in order to maintain average daily performance levels of approximately 60% of trials correct. Participants complete 35-45 minutes of active training per day, 5 days a week for 5 weeks.~Cogmed RM - Online adaptive working memory training intervention"
11152747|NCT01892007|BG001|Baseline|Active Control: Cogmed RM (Non-adaptive, Placebo)|"Online training intervention: A non-adaptive placebo version of Cogmed RM working memory training. Tasks are fixed at a low-difficulty practice level (three to-be-remembered items) and do not increase in difficulty over the course of the intervention. Participants complete 35-45 minutes of active placebo training per day, 5 days a week for 5 weeks.~Cogmed RM - Online (non-adaptive, placebo) working memory training intervention"
11152748|NCT01892007|BG002|Baseline|Total|Total of all reporting groups
11152749|NCT01892007|FG000|Participant Flow|Cogmed RM (Adaptive)|"Online training intervention: An adaptive version of Cogmed RM working memory training. Task difficulty (number of to-be-remembered items) increases based on individual performance, in order to maintain average daily performance levels of approximately 60% of trials correct. Participants complete 35-45 minutes of active training per day, 5 days a week for 5 weeks.~Cogmed RM - Online adaptive working memory training intervention"
11152750|NCT01892007|FG001|Participant Flow|Active Control: Cogmed RM (Non-adaptive, Placebo)|"Online training intervention: A non-adaptive placebo version of Cogmed RM working memory training. Tasks are fixed at a low-difficulty practice level (three to-be-remembered items) and do not increase in difficulty over the course of the intervention. Participants complete 35-45 minutes of active placebo training per day, 5 days a week for 5 weeks.~Cogmed RM - Online (non-adaptive, placebo) working memory training intervention"
11228072|NCT02388191|OG000|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
11228073|NCT02388191|OG001|Outcome|Placebo|"Placebo~Placebo tablet"
11152751|NCT01892007|OG000|Outcome|Cogmed RM (Adaptive)|"Online training intervention: An adaptive version of Cogmed RM working memory training. Task difficulty (number of to-be-remembered items) increases based on individual performance, in order to maintain average daily performance levels of approximately 60% of trials correct. Participants complete 35-45 minutes of active training per day, 5 days a week for 5 weeks.~Cogmed RM - Online adaptive working memory training intervention"
11152752|NCT01892007|OG001|Outcome|Active Control: Cogmed RM (Non-adaptive, Placebo)|"Online training intervention: A non-adaptive placebo version of Cogmed RM working memory training. Tasks are fixed at a low-difficulty practice level (three to-be-remembered items) and do not increase in difficulty over the course of the intervention. Participants complete 35-45 minutes of active placebo training per day, 5 days a week for 5 weeks.~Cogmed RM - Online (non-adaptive, placebo) working memory training intervention"
11152753|NCT01892007|EG000|Reported Event|Cogmed RM (Adaptive)|"Online training intervention: An adaptive version of Cogmed RM working memory training. Task difficulty (number of to-be-remembered items) increases based on individual performance, in order to maintain average daily performance levels of approximately 60% of trials correct. Participants complete 35-45 minutes of active training per day, 5 days a week for 5 weeks.~Cogmed RM - Online adaptive working memory training intervention"
11152754|NCT01892007|EG001|Reported Event|Active Control: Cogmed RM (Non-adaptive, Placebo)|"Online training intervention: A non-adaptive placebo version of Cogmed RM working memory training. Tasks are fixed at a low-difficulty practice level (three to-be-remembered items) and do not increase in difficulty over the course of the intervention. Participants complete 35-45 minutes of active placebo training per day, 5 days a week for 5 weeks.~Cogmed RM - Online (non-adaptive, placebo) working memory training intervention"
11152755|NCT01892020|BG000|Baseline|All Subjects|In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). Group B received BHI 50 BID during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).
11152756|NCT01892020|FG000|Participant Flow|Group A (BIAsp 50 - BHI 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.~Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
11152757|NCT01892020|FG001|Participant Flow|Group B (BHI 50 - BIAsp 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.~Group B received BHI 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
11152758|NCT01892020|OG000|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
11152759|NCT01892020|OG001|Outcome|BHI 50|This arm included the subjects received BHI 50.
11152760|NCT01892020|EG000|Reported Event|BIAsp 50|This arm included the subjects received BIAsp 50.
11152761|NCT01892020|EG001|Reported Event|BHI 50|This arm included the subjects received BHI 50.
11152762|NCT01892163|BG000|Baseline|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
11152763|NCT01892163|BG001|Baseline|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
11152764|NCT01892163|BG002|Baseline|Total|Total of all reporting groups
11152765|NCT01892163|FG000|Participant Flow|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
11152766|NCT01892163|FG001|Participant Flow|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
11152767|NCT01892163|OG000|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
11152768|NCT01892163|OG001|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
11152769|NCT01892163|EG000|Reported Event|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
11152770|NCT01892163|EG001|Reported Event|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
11152771|NCT01892189|BG000|Baseline|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152772|NCT01892189|BG001|Baseline|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11228074|NCT02388191|EG000|Reported Event|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
11152773|NCT01892189|BG002|Baseline|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152774|NCT01892189|BG003|Baseline|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152775|NCT01892189|BG004|Baseline|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152776|NCT01892189|BG005|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152777|NCT01892189|BG006|Baseline|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152778|NCT01892189|BG007|Baseline|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152779|NCT01892189|BG008|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152780|NCT01892189|BG009|Baseline|Total|Total of all reporting groups
11152781|NCT01892189|FG000|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152782|NCT01892189|FG001|Participant Flow|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152783|NCT01892189|FG002|Participant Flow|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11228075|NCT02388191|EG001|Reported Event|Placebo|"Placebo~Placebo tablet"
11228076|NCT02388269|BG000|Baseline|gammaCore®-G Functional Dyspepsia|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
10887705|NCT00502593|BG004|Baseline|GSK1562902A-B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11152784|NCT01892189|FG003|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152785|NCT01892189|FG004|Participant Flow|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152786|NCT01892189|FG005|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152787|NCT01892189|FG006|Participant Flow|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152788|NCT01892189|FG007|Participant Flow|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152789|NCT01892189|FG008|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
11152790|NCT01892189|OG000|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
11152791|NCT01892189|OG001|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
11152792|NCT01892189|OG002|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
11152793|NCT01892189|OG003|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
11152794|NCT01892189|OG000|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
11152795|NCT01892189|OG001|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
11152796|NCT01892189|OG002|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
11152797|NCT01892189|OG004|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
11152798|NCT01892189|EG000|Reported Event|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
11152799|NCT01892189|EG001|Reported Event|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
11152800|NCT01892189|EG002|Reported Event|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
11152801|NCT01892189|EG003|Reported Event|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
11152802|NCT01892189|EG004|Reported Event|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
11152803|NCT01892267|BG000|Baseline|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
11152804|NCT01892267|BG001|Baseline|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
11152805|NCT01892267|BG002|Baseline|Total|Total of all reporting groups
11152806|NCT01892267|FG000|Participant Flow|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
11152807|NCT01892267|FG001|Participant Flow|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
11152808|NCT01892267|OG000|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
11152809|NCT01892267|OG001|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
11152810|NCT01892267|EG000|Reported Event|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
11152811|NCT01892267|EG001|Reported Event|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
11152812|NCT01892293|BG000|Baseline|NY-ESO-1ᶜ²⁵⁹T Cells Administered IV|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
11152813|NCT01892293|FG000|Participant Flow|NY-ESO-1ᶜ²⁵⁹T Cells Administered IV|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
11152814|NCT01892293|OG000|Outcome|NY-ESO-1ᶜ²⁵⁹T Cells Administered IV|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
11152815|NCT01892293|EG000|Reported Event|NY-ESO-1ᶜ²⁵⁹T Cells Administered IV|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
11152816|NCT01892306|BG000|Baseline|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
11152817|NCT01892306|BG001|Baseline|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
11152818|NCT01892306|BG002|Baseline|Total|Total of all reporting groups
11152819|NCT01892306|FG000|Participant Flow|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
11152820|NCT01892306|FG001|Participant Flow|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
11152821|NCT01892306|OG000|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
11152822|NCT01892306|OG001|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
11152823|NCT01892306|EG000|Reported Event|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
11152824|NCT01892306|EG001|Reported Event|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
11152825|NCT01892345|BG000|Baseline|Eculizumab|"Induction Period: Participants received eculizumab (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4).~Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards."
11152826|NCT01892345|BG001|Baseline|Placebo|"Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4).~Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards."
11152827|NCT01892345|BG002|Baseline|Total|Total of all reporting groups
11152828|NCT01892345|FG000|Participant Flow|Eculizumab|"Induction Period: Participants received eculizumab (900 milligrams [mg]) via intravenous (IV) infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4).~Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards."
11152829|NCT01892345|FG001|Participant Flow|Placebo|"Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4).~Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards."
11152830|NCT01892345|OG000|Outcome|Eculizumab|"Induction Period: Participants received eculizumab (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4).~Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards."
11152831|NCT01892345|OG001|Outcome|Placebo|"Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4).~Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards."
11152832|NCT01892345|EG000|Reported Event|Eculizumab|"Induction Period: Participants received eculizumab (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4).~Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards."
11228077|NCT02388269|BG001|Baseline|gammaCore®-G Sham Functional Dyspepsia|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
11152833|NCT01892345|EG001|Reported Event|Placebo|"Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4).~Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards."
11152834|NCT01892436|BG000|Baseline|Secukinumab 75mg|Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
11152835|NCT01892436|BG001|Baseline|Secukinumab 150mg|Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
11152836|NCT01892436|BG002|Baseline|Placebo - AIN457A 75mg|Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
11152837|NCT01892436|BG003|Baseline|Placebo - AIN457 150mg|Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
11152838|NCT01892436|BG004|Baseline|Total|Total of all reporting groups
11152839|NCT01892436|FG000|Participant Flow|Secukinumab 75mg|Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
11152840|NCT01892436|FG001|Participant Flow|Secukinumab 150mg|Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
11152841|NCT01892436|FG002|Participant Flow|Placebo - AIN457A 75mg|Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
11152842|NCT01892436|FG003|Participant Flow|Placebo - AIN457 150mg|Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
11152843|NCT01892436|OG000|Outcome|Secukinumab 75mg|Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
11152844|NCT01892436|OG001|Outcome|Secukinumab 150mg|Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
11152845|NCT01892436|OG002|Outcome|Placebo - AIN457A 75mg|Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
11152846|NCT01892436|OG003|Outcome|Placebo - AIN457 150mg|Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
11152847|NCT01892436|EG000|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg
11152848|NCT01892436|EG001|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
11152849|NCT01892436|EG002|Reported Event|Any AIN457 300 mg|Any AIN457 300 mg
11152850|NCT01892436|EG003|Reported Event|Placebo|Placebo
11152851|NCT01892501|BG000|Baseline|Hypermetabolic Mediastinal Lymph Nodes in PET,|"Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.~Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.~Pathological samples are taken :~3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.~PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts"
11152852|NCT01892501|FG000|Participant Flow|Hypermetabolic Mediastinal Lymph Nodes in PET,|"Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.~Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.~Pathological samples are taken :~3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.~PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts"
11152853|NCT01892501|OG000|Outcome|Hypermetabolic Mediastinal Lymph Nodes in PET,|"Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.~Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.~Pathological samples are taken :~3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.~PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts"
11152854|NCT01892501|EG000|Reported Event|Hypermetabolic Mediastinal Lymph Nodes in PET,|"Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.~Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.~Pathological samples are taken :~3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.~PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts"
11152855|NCT01892540|BG000|Baseline|Cohort 1: Standard Positioning Device|"Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.~positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging"
11152856|NCT01892540|BG001|Baseline|Cohort 2: New Positioning Device|"positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging~Position Device"
11152857|NCT01892540|BG002|Baseline|Cohort 3: Current Positioning Device Until New is Available|"positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging~Position Device"
11152858|NCT01892540|BG003|Baseline|Total|Total of all reporting groups
11152859|NCT01892540|FG000|Participant Flow|Cohort 1: Standard Positioning Device|"Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.~positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging"
11152860|NCT01892540|FG001|Participant Flow|Cohort 2: New Positioning Device|"positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging~Position Device"
11152861|NCT01892540|FG002|Participant Flow|Cohort 3: Current Positioning Device Until New is Available|"positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging~Position Device"
11152862|NCT01892540|OG000|Outcome|Cohort 1: Standard Positioning Device|"Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.~positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging"
11152863|NCT01892540|OG001|Outcome|Cohort 2: New Positioning Device|"positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging~Position Device"
11152864|NCT01892540|OG002|Outcome|Cohort 3: Current Positioning Device Until New is Available|"positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging~Position Device"
11152865|NCT01892540|EG000|Reported Event|Cohort 1: Standard Positioning Device|"Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.~positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging"
11152866|NCT01892540|EG001|Reported Event|Cohort 2: New Positioning Device|"positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging~Position Device"
11152867|NCT01892540|EG002|Reported Event|Cohort 3: Current Positioning Device Until New is Available|"positron emission tomography/computed tomography: Undergo PET/CT~PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging~Position Device"
11173826|NCT02018042|BG000|Baseline|Abatacept|"Patients will be treated with abatacept 125mg subcutaneous (SC) self-administered each week. Treatment will be continued for 6 months to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with alopecia areata. Patients will then be followed for an additional 6 months to assess the timing and incidence of relapse.~Abatacept: After the screening period, subjects will begin weekly self-administered subcutaneous abatacept and will continue treatment for 6 months. Patients will be instructed in self-administration of study medication at baseline (week zero) and will be observed self-administering medication at each visit. Instructions regarding study drug administration will be reinforced as needed.~The 6-month treatment period is expected to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with moderate to severe AAP. Responders will then be followed for 6 months off drug."
11173827|NCT02018042|FG000|Participant Flow|Abatacept|"Patients will be treated with abatacept 125mg subcutaneous (SC) self-administered each week. Treatment will be continued for 6 months to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with alopecia areata. Patients will then be followed for an additional 6 months to assess the timing and incidence of relapse.~Abatacept: After the screening period, subjects will begin weekly self-administered subcutaneous abatacept and will continue treatment for 6 months. Patients will be instructed in self-administration of study medication at baseline (week zero) and will be observed self-administering medication at each visit. Instructions regarding study drug administration will be reinforced as needed.~The 6-month treatment period is expected to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with moderate to severe AAP. Responders will then be followed for 6 months off drug."
10851397|NCT00306202|OG007|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
11152868|NCT01892657|BG000|Baseline|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
11152869|NCT01892657|FG000|Participant Flow|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
11152870|NCT01892657|OG000|Outcome|Patch 1|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152871|NCT01892657|OG001|Outcome|Patch 2|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152872|NCT01892657|OG002|Outcome|Patch 3|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152873|NCT01892657|OG003|Outcome|Patch 4|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152874|NCT01892657|OG004|Outcome|Patch 5|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152875|NCT01892657|OG005|Outcome|Patch 6|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152876|NCT01892657|OG006|Outcome|Patch 7|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152877|NCT01892657|OG007|Outcome|Patch 8|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152878|NCT01892657|OG008|Outcome|Patch 9|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
11152879|NCT01892657|OG009|Outcome|Challenge Patch (Original Site) - 48 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded at 48 hours.
11152880|NCT01892657|OG010|Outcome|Challenge Patch (Original Site) - 96 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded again at 96 hours.
11152881|NCT01892657|OG011|Outcome|Challenge Patch (Alternate Site) - 48 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded at 48 hours.
11152882|NCT01892657|OG012|Outcome|Challenge Patch (Alternate Site) - 96 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded again at 96 hours.
11152883|NCT01892657|EG000|Reported Event|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
11152884|NCT01892709|BG000|Baseline|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
11152885|NCT01892709|FG000|Participant Flow|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
11152886|NCT01892709|OG000|Outcome|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
11152887|NCT01892709|OG000|Outcome|1 mg Hydromorphone|"Received 1 mg of IV hydromorphone, and answered no to all repeated questions of Do you want more pain medication?"
11152888|NCT01892709|OG001|Outcome|2 mg Hydromorphone|Received 2 mg of IV hydromorphone, in 2 1-mg doses.
11152889|NCT01892709|OG002|Outcome|3 mg Hydromorphone|Received 3 mg of IV hydromorphone, in 3 1-mg doses
11152890|NCT01892709|OG003|Outcome|4 mg Hydromorphone|Received 4 mg of IV hydromorphone, in 4 1-mg doses
11152891|NCT01892709|EG000|Reported Event|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
11152892|NCT01892865|BG000|Baseline|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
11152893|NCT01892865|BG001|Baseline|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
11152894|NCT01892865|BG002|Baseline|Total|Total of all reporting groups
11152895|NCT01892865|FG000|Participant Flow|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
11152896|NCT01892865|FG001|Participant Flow|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
11152897|NCT01892865|OG000|Outcome|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
11152898|NCT01892865|OG001|Outcome|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
11152899|NCT01892865|EG000|Reported Event|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
11152900|NCT01892865|EG001|Reported Event|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
11152901|NCT01893203|BG000|Baseline|BF-200 ALA vs MAL|BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design
11152902|NCT01893203|FG000|Participant Flow|BF200 ALA vs MAL|5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
11152903|NCT01893203|OG000|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
11152904|NCT01893203|EG000|Reported Event|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized slipt face design on symmetrical treatment areas.
11152905|NCT01893281|BG000|Baseline|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
11152906|NCT01893281|FG000|Participant Flow|Topical Testosterone Solution|Testosterone, initially 60 milligrams (mg) once daily (QD), titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
11152907|NCT01893281|OG000|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
11152908|NCT01893281|EG000|Reported Event|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
11152909|NCT01893346|BG000|Baseline|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
11152910|NCT01893346|BG001|Baseline|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
11152911|NCT01893346|BG002|Baseline|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
11152912|NCT01893346|BG003|Baseline|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
11152913|NCT01893346|BG004|Baseline|Total|Total of all reporting groups
11152914|NCT01893346|FG000|Participant Flow|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
11152915|NCT01893346|FG001|Participant Flow|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
10887706|NCT00502593|BG005|Baseline|Fluarix-B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11152916|NCT01893346|FG002|Participant Flow|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
11152917|NCT01893346|FG003|Participant Flow|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
11152918|NCT01893346|OG000|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
11152919|NCT01893346|OG001|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
11152920|NCT01893346|OG002|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
11152921|NCT01893346|OG003|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
11152922|NCT01893346|EG000|Reported Event|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
11152923|NCT01893346|EG001|Reported Event|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
11152924|NCT01893346|EG002|Reported Event|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
11152925|NCT01893346|EG003|Reported Event|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
11152926|NCT01893372|BG000|Baseline|Eltrombopag|"Eltrombopag 200 mg by mouth daily in a 28 day cycle.~Eltrombopag: 200 mg by mouth daily in a 28 day cycle."
11152927|NCT01893372|BG001|Baseline|Eltrombopag + Hypomethylating Agent (HMA)|"Eltrombopag in combination with continuation of hypomethylating agent in 28-day cycles. Eltrombopag 200 mg by mouth daily in a 28 day cycle.~The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study. Eltrombopag should be initiated at the start of the next HMA cycle whenever possible so the start date of both agents is consistent.~Eltrombopag: 200 mg by mouth daily in a 28 day cycle.~Hypomethylating Agent (HMA): The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study."
11152928|NCT01893372|BG002|Baseline|Total|Total of all reporting groups
11152929|NCT01893372|FG000|Participant Flow|Eltrombopag|"Eltrombopag 200 mg by mouth daily in a 28 day cycle.~Eltrombopag: 200 mg by mouth daily in a 28 day cycle."
11152930|NCT01893372|FG001|Participant Flow|Eltrombopag + Hypomethylating Agent (HMA)|"Eltrombopag in combination with continuation of hypomethylating agent in 28-day cycles. Eltrombopag 200 mg by mouth daily in a 28 day cycle.~The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study. Eltrombopag should be initiated at the start of the next HMA cycle whenever possible so the start date of both agents is consistent.~Eltrombopag: 200 mg by mouth daily in a 28 day cycle.~Hypomethylating Agent (HMA): The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study."
11152931|NCT01893372|OG000|Outcome|Eltrombopag|"Eltrombopag 200 mg by mouth daily in a 28 day cycle.~Eltrombopag: 200 mg by mouth daily in a 28 day cycle."
11228078|NCT02388269|BG002|Baseline|gammaCore®-G Irritable Bowel Syndrome|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
11228079|NCT02388269|BG003|Baseline|gammaCore®-G Sham Irritale Bowel Syndrome|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
11228080|NCT02388269|BG004|Baseline|Total|Total of all reporting groups
11228081|NCT02388269|FG000|Participant Flow|gammaCore®-G|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
11228082|NCT02388269|FG001|Participant Flow|gammaCore®-G Sham|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
11228083|NCT02388269|FG002|Participant Flow|Not Randomised|Subjects that were not randomised, i.e. screen failures
11228084|NCT02388269|OG000|Outcome|gammaCore®-G|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
11228085|NCT02388269|OG001|Outcome|gammaCore®-G Sham|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
11228086|NCT02388269|OG000|Outcome|gammaCore®-G FD|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
11228087|NCT02388269|OG001|Outcome|gammaCore®-G Sham FD|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
11228088|NCT02388269|OG002|Outcome|gammaCore®-G IBS|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
11228089|NCT02388269|OG003|Outcome|gammaCore®-G Sham IBS|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
11228090|NCT02388269|OG000|Outcome|Frequency of Symptoms Over Last 2 Months - ACTIVE|Active Comparator: Active gammaCore device How often have you had this symptom over the last 2 months?
11228091|NCT02388269|OG001|Outcome|Frequency of Symptoms Over the Last 2 Months - SHAM|Sham Comparator: sham gammaCore device How often have you had this symptom over the last 2 months?
11228092|NCT02388269|OG002|Outcome|Interference With Normal Activities - ACTIVE|Active Comparator: Active gammaCore device How often has this symptom interfered with your normal activities over the last 2 months?
11228093|NCT02388269|OG003|Outcome|Interference With Normal Activities - SHAM|Sham Comparator: sham gammaCore device How often has this symptom interfered with your normal activities over the last 2 months?
11228094|NCT02388269|OG000|Outcome|Functional Dyspepsia Cohort Active|Functional Dyspepsia Cohort - Active gammacore
11228095|NCT02388269|OG001|Outcome|Functional Dyspepsia Cohort Sham|Functional Dyspepsia Cohort - Sham gammacore
11228096|NCT02388269|OG002|Outcome|Irritable Bowel Syndrome Cohort|Irritable Bowel Syndrome Cohort - Active gammacore
11228097|NCT02388269|OG003|Outcome|Irritable Bowel Syndrome Cohort Sham|Irritable Bowel Syndrome Cohort - Sham gammacore
11228098|NCT02388269|OG004|Outcome|Total Active Gammacore|Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
11228099|NCT02388269|OG005|Outcome|Total Sham Gammacore|Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
11228100|NCT02388269|OG000|Outcome|gammaCore®-G|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment - Functional Dyspepsia Cohort"
11228101|NCT02388269|OG001|Outcome|gammaCore®-G Sham|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment - Functional Dyspepsia Cohort"
11228102|NCT02388269|EG000|Reported Event|gammaCore®-G FD|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
11228103|NCT02388269|EG001|Reported Event|gammaCore®-G Sham FD|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
11228104|NCT02388269|EG002|Reported Event|gammaCore®-G IBS|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
11228105|NCT02388269|EG003|Reported Event|gammaCore®-G Sham IBS|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
11228106|NCT02388295|BG000|Baseline|Placebo|Placebo to match AZD3241 dosed twice daily
11228107|NCT02388295|BG001|Baseline|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
11228108|NCT02388295|BG002|Baseline|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
11228109|NCT02388295|BG003|Baseline|Total|Total of all reporting groups
11228110|NCT02388295|FG000|Participant Flow|Placebo|Placebo to match AZD3241 dosed twice daily
11228111|NCT02388295|FG001|Participant Flow|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
11228112|NCT02388295|FG002|Participant Flow|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
11228113|NCT02388295|OG000|Outcome|Placebo|Placebo to match AZD3241 dosed twice daily
11228114|NCT02388295|OG001|Outcome|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
11228115|NCT02388295|OG002|Outcome|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
11228116|NCT02388295|EG000|Reported Event|Placebo|Placebo to match AZD3241 dosed twice daily
11228117|NCT02388295|EG001|Reported Event|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
11228118|NCT02388295|EG002|Reported Event|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
11228119|NCT02388321|BG000|Baseline|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
11228120|NCT02388321|BG001|Baseline|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
11228121|NCT02388321|BG002|Baseline|Total|Total of all reporting groups
11228122|NCT02388321|FG000|Participant Flow|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
11228123|NCT02388321|FG001|Participant Flow|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
11228124|NCT02388321|OG000|Outcome|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
11228125|NCT02388321|OG001|Outcome|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
11349128|NCT04117607|FG012|Participant Flow|BA 1|"100 mg (1 injection of 1.0 mL) or maximum tolerated dose (MTD) of Rezafungin, determined in part 1 of the study (SAD), administered subcutaneously into the abdomen on Day 1, and 100 mg (250 mL) or MTD of Rezafungin administered via intravenous infusion over 60 minutes on Day 22 in an open label manner.~Rezafungin for subcutaneous use: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.~Rezafungin for intravenous infusion: Rezafungin, 200 mg/vial, is a sterile product supplied as a white to pale yellow lyophilized powder in single-dose glass vials for reconstitution with Sterile Water for Injection, United States Pharmacopeia (USP). The reconstituted product is diluted in 0.9% Sodium Chloride Injection, USP for IV infusion. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredients include excipients of mannitol, polysorbate 80, and histidine."
11349129|NCT04117607|FG013|Participant Flow|BA 2|"100 mg (250 mL) or maximum tolerated dose (MTD) of Rezafungin, determined in part 1 of the study (SAD), administered via intravenous infusion over 60 minutes on Day 1, and 100 mg (1 injection of 1.0 mL) or MTD of Rezafungin administered subcutaneously into the abdomen on Day 22 in an open label manner.~Rezafungin for subcutaneous use: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.~Rezafungin for intravenous infusion: Rezafungin, 200 mg/vial, is a sterile product supplied as a white to pale yellow lyophilized powder in single-dose glass vials for reconstitution with Sterile Water for Injection, United States Pharmacopeia (USP). The reconstituted product is diluted in 0.9% Sodium Chloride Injection, USP for IV infusion. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredients include excipients of mannitol, polysorbate 80, and histidine."
11349130|NCT04117607|OG000|Outcome|SAD1|1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
11349131|NCT04117607|OG001|Outcome|SAD2|10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
11349132|NCT04117607|OG002|Outcome|SAD Placebo|Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
11349133|NCT04117607|OG000|Outcome|MAD1|30 mg (1 injection of 0.3 mL) of Rezafungin administered subcutaneously.
11349134|NCT04117607|OG001|Outcome|MAD2|60 mg (1 injection of 0.6 mL) of Rezafungin administered subcutaneously.
11349135|NCT04117607|OG002|Outcome|MAD3|100 mg (1 injection of 1.0 mL) of Rezafungin administered subcutaneously.
11349136|NCT04117607|OG003|Outcome|MAD4|200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
11349137|NCT04117607|OG004|Outcome|MAD Placebo|Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
11349138|NCT04117607|OG000|Outcome|SAD2|10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
10887707|NCT00502593|BG006|Baseline|GSK1562902A-B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11349139|NCT04117607|OG000|Outcome|BA 1|100 mg (1 injection of 1.0 mL) or maximum tolerated dose (MTD) determined in SAD of Rezafungin administered subcutaneously into the abdomen on Day 1, and 100 mg (250 mL) or MTD of Rezafungin administered via intravenous infusion on Day 22 in an open label manner.
11349140|NCT04117607|OG001|Outcome|BA 2|100 mg (250 mL) or maximum tolerated dose (MTD) determined in SAD of Rezafungin administered via intravenous infusion on Day 1, and 100 mg (1 injection of 1.0 mL) or MTD of Rezafungin administered subcutaneously into the abdomen on Day 22 in an open label manner.
11349141|NCT04117607|EG000|Reported Event|SAD1|"1 mg (1 injection of 0.1 ml diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously into the abdomen as a single dose, n=3 (no sentinel dosing) on Day 1 in a double-blind manner.~Randomized 3:1."
11349142|NCT04117607|EG001|Reported Event|SAD2|"10 mg (1 injection of 0.1 ml) of Rezafungin administered subcutaneously into the abdomen as a single dose, n=6 (1 sentinel, 5 non-sentinel) on Day 1 in a double-blind manner.~Randomized 3:1."
11349143|NCT04117607|EG002|Reported Event|SAD Placebo|Placebo participants across all SAD cohorts: 1 mg (1 injection of 0.1 ml diluted 1:10 in 5% Dextrose Injection, USP), 10 mg (1 injection of 0.1 ml), 30 mg (1 injection of 0.3 ml)
11349144|NCT04116684|BG000|Baseline|Intervention Group (Digital BP Monitoring)|"This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments.~Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone."
11349145|NCT04116684|BG001|Baseline|Standard of Care BP Monitoring|This group will use a standard BP cuff and record and transmit data to their medical team as instructed by their providers or if they are concerned.
11349146|NCT04116684|BG002|Baseline|Total|Total of all reporting groups
11349147|NCT04116684|FG000|Participant Flow|Standard of Care BP Monitoring|This group will use a standard BP cuff and record and transmit data to their medical team as instructed by their providers or if they are concerned.
11349148|NCT04116684|FG001|Participant Flow|Intervention Group (Digital BP Monitoring)|"This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments.~Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone."
11349149|NCT04116684|OG000|Outcome|Standard of Care BP Monitoring|This group will use a standard BP cuff and record and transmit data to their medical team as instructed by their providers or if they are concerned.
11152932|NCT01893372|OG001|Outcome|Eltrombopag + Hypomethylating Agent (HMA)|"Eltrombopag in combination with continuation of hypomethylating agent in 28-day cycles. Eltrombopag 200 mg by mouth daily in a 28 day cycle.~The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study. Eltrombopag should be initiated at the start of the next HMA cycle whenever possible so the start date of both agents is consistent.~Eltrombopag: 200 mg by mouth daily in a 28 day cycle.~Hypomethylating Agent (HMA): The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study."
11152933|NCT01893372|EG000|Reported Event|Eltrombopag|"Eltrombopag 200 mg by mouth daily in a 28 day cycle.~Eltrombopag: 200 mg by mouth daily in a 28 day cycle."
11152934|NCT01893372|EG001|Reported Event|Eltrombopag + Hypomethylating Agent (HMA)|"Eltrombopag in combination with continuation of hypomethylating agent in 28-day cycles. Eltrombopag 200 mg by mouth daily in a 28 day cycle.~The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study. Eltrombopag should be initiated at the start of the next HMA cycle whenever possible so the start date of both agents is consistent.~Eltrombopag: 200 mg by mouth daily in a 28 day cycle.~Hypomethylating Agent (HMA): The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study."
11152935|NCT01893411|BG000|Baseline|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
11152936|NCT01893411|BG001|Baseline|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
11152937|NCT01893411|BG002|Baseline|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
11152938|NCT01893411|BG003|Baseline|Total|Total of all reporting groups
11152939|NCT01893411|FG000|Participant Flow|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 Unit per kilogram (U/kg) Body Weight (BW) of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
11152940|NCT01893411|FG001|Participant Flow|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
11152941|NCT01893411|FG002|Participant Flow|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
11152942|NCT01893411|OG000|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
11152943|NCT01893411|OG001|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
11152944|NCT01893411|OG002|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
11152945|NCT01893411|EG000|Reported Event|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 Unit per kilogram (U/kg) Body Weight (BW) of IncobotulinumtoxinA (Xeomin) with a maximum of 400 U per injection treatment via intramuscular injection into spastic muscles.
11152946|NCT01893411|EG001|Reported Event|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 U per injection treatment via intramuscular injection into spastic muscles.
11152947|NCT01893411|EG002|Reported Event|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 U per injection treatment via intramuscular injection into spastic muscles.
11152948|NCT01893567|BG000|Baseline|Clobex Spray|Clobex Spray
11152949|NCT01893567|FG000|Participant Flow|Clobex Spray|Clobex Spray
11152950|NCT01893567|OG000|Outcome|Clobex Spray|Clobex Spray
11152951|NCT01893567|EG000|Reported Event|Clobex Spray|Clobex Spray
11152952|NCT01893632|BG000|Baseline|Gabapentin|"All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.~gabapentin"
11152953|NCT01893632|BG001|Baseline|Placebo|"Capsules filled with riboflavin.~Placebo"
11152954|NCT01893632|BG002|Baseline|Total|Total of all reporting groups
11152955|NCT01893632|FG000|Participant Flow|Gabapentin|"All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.~gabapentin"
11152956|NCT01893632|FG001|Participant Flow|Placebo|"Capsules filled with riboflavin.~Placebo"
11152957|NCT01893632|OG000|Outcome|Gabapentin|"All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.~gabapentin"
11152958|NCT01893632|OG001|Outcome|Placebo|"Capsules filled with riboflavin.~Placebo"
11152959|NCT01893632|EG000|Reported Event|Gabapentin|"All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.~gabapentin"
11152960|NCT01893632|EG001|Reported Event|Placebo|"Capsules filled with riboflavin.~Placebo"
11152961|NCT01893801|BG000|Baseline|Nab-Paclitaxel+Cisplatin+Gemcitabine|"This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.~Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle~Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle~Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle"
11152962|NCT01893801|FG000|Participant Flow|Nab-Paclitaxel+Cisplatin+Gemcitabine|"This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.~Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle~Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle~Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle"
11152963|NCT01893801|OG000|Outcome|Nab-Paclitaxel+Cisplatin+Gemcitabine|"This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.~Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle~Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle~Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle"
11152964|NCT01893801|OG000|Outcome|Nab-Pac+Cis+Gem|Nab-Paclitaxel+Cisplatin+Gemcitabine
11152965|NCT01893801|OG000|Outcome|Nab-Pac+Cis+Gem|"This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.~Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle~Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle~Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle"
11152966|NCT01893801|EG000|Reported Event|Nab-Paclitaxel+Cisplatin+Gemcitabine|"This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.~Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle~Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle~Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle"
11152967|NCT01893827|BG000|Baseline|XR-NTX|"Xr-NTX 380mg IM injection monthly x 6 months~XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months."
11152968|NCT01893827|BG001|Baseline|Oral Naltrexone|"Oral naltrexone 50mg/day x 6 months~Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months."
11152969|NCT01893827|BG002|Baseline|Total|Total of all reporting groups
11152970|NCT01893827|FG000|Participant Flow|XR-NTX|"Xr-NTX 380mg IM injection monthly x 6 months~XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months."
11152971|NCT01893827|FG001|Participant Flow|Oral Naltrexone|"Oral naltrexone 50mg/day x 6 months~Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months."
11152972|NCT01893827|OG000|Outcome|XR-NTX|"Xr-NTX 380mg IM injection monthly x 6 months~XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months."
11152973|NCT01893827|OG001|Outcome|Oral Naltrexone|"Oral naltrexone 50mg/day x 6 months~Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months."
11152974|NCT01893827|EG000|Reported Event|XR-NTX|"Xr-NTX 380mg IM injection monthly x 6 months~XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months."
11152975|NCT01893827|EG001|Reported Event|Oral Naltrexone|"Oral naltrexone 50mg/day x 6 months~Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months."
11152976|NCT01893879|BG000|Baseline|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
11152977|NCT01893879|BG001|Baseline|Placebo for Study Drug|"Patients receive placebo three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
11152978|NCT01893879|BG002|Baseline|Total|Total of all reporting groups
11152979|NCT01893879|FG000|Participant Flow|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
11152980|NCT01893879|FG001|Participant Flow|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
11152981|NCT01893879|OG000|Outcome|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
11152982|NCT01893879|OG001|Outcome|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
11152983|NCT01893879|EG000|Reported Event|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
11152984|NCT01893879|EG001|Reported Event|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
11152985|NCT01893905|BG000|Baseline|CS+SG|Chondroitin sulfate+glucosamine sulfate
11152986|NCT01893905|BG001|Baseline|Placebo|Placebo oral
11152987|NCT01893905|BG002|Baseline|Total|Total of all reporting groups
11152988|NCT01893905|FG000|Participant Flow|CS+SG|Chondroitin sulfate+ glucosamine sulfate
11152989|NCT01893905|FG001|Participant Flow|Placebo|Oral Placebo
11152990|NCT01893905|OG000|Outcome|CS+SG|Chondroitin sulfate+glucosamine sulfate
11152991|NCT01893905|OG001|Outcome|Placebo|Placebo Oral
11152992|NCT01893905|EG000|Reported Event|CS+SG|chondroitin sulfate+glucosamine sulfate
11152993|NCT01893905|EG001|Reported Event|Placebo|Placebo oral
11152994|NCT01893983|BG000|Baseline|Motivational Coaching|"Telephone based Motivational Coaching sessions~Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment"
11152995|NCT01893983|BG001|Baseline|Referral Alone|This is the current standard of care
11152996|NCT01893983|BG002|Baseline|Total|Total of all reporting groups
11152997|NCT01893983|FG000|Participant Flow|Motivational Coaching|"Telephone based Motivational Coaching sessions~Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment"
11152998|NCT01893983|FG001|Participant Flow|Referral Alone|This is the current standard of care
11152999|NCT01893983|OG000|Outcome|Motivational Coaching|"Telephone based Motivational Coaching sessions~Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment"
11153000|NCT01893983|OG001|Outcome|Referral Alone|This is the current standard of care
11153001|NCT01893983|EG000|Reported Event|Motivational Coaching|"Telephone based Motivational Coaching sessions~Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment"
11153002|NCT01893983|EG001|Reported Event|Referral Alone|This is the current standard of care
11153003|NCT01894022|BG000|Baseline|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11153004|NCT01894022|BG001|Baseline|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11153005|NCT01894022|BG002|Baseline|Total|Total of all reporting groups
11153006|NCT01894022|FG000|Participant Flow|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11153007|NCT01894022|FG001|Participant Flow|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11153008|NCT01894022|OG000|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11153009|NCT01894022|OG001|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11153010|NCT01894022|OG001|Outcome|Ambrisentan 5 mg|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11153011|NCT01894022|EG000|Reported Event|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11153012|NCT01894022|EG001|Reported Event|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
11228126|NCT02388321|EG000|Reported Event|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
11153013|NCT01894087|BG000|Baseline|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
11153014|NCT01894087|BG001|Baseline|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
11153015|NCT01894087|BG002|Baseline|Total|Total of all reporting groups
11153016|NCT01894087|FG000|Participant Flow|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
11153017|NCT01894087|FG001|Participant Flow|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
11153018|NCT01894087|OG000|Outcome|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
11153019|NCT01894087|OG001|Outcome|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
11153020|NCT01894087|EG000|Reported Event|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
11153021|NCT01894087|EG001|Reported Event|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
11153022|NCT01894100|BG000|Baseline|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
11153023|NCT01894100|BG001|Baseline|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
11153024|NCT01894100|BG002|Baseline|Total|Total of all reporting groups
11153025|NCT01894100|FG000|Participant Flow|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
11153026|NCT01894100|FG001|Participant Flow|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
11153027|NCT01894100|OG000|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
11153028|NCT01894100|OG001|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
11153029|NCT01894100|EG000|Reported Event|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
11153030|NCT01894100|EG001|Reported Event|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
11153031|NCT01894152|BG000|Baseline|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
11153032|NCT01894152|FG000|Participant Flow|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
11153033|NCT01894152|OG000|Outcome|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
11153034|NCT01894152|EG000|Reported Event|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
11153035|NCT01894178|BG000|Baseline|Parker Flex-Tip® Tracheal Tube|"Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube~Parker Flex-Tip® tracheal tube"
11153036|NCT01894178|BG001|Baseline|Portex® Tracheal Tube|"Intubation of obese patients with the Portex® Tracheal Tube~Portex® Tracheal Tube"
11153037|NCT01894178|BG002|Baseline|Total|Total of all reporting groups
11153038|NCT01894178|FG000|Participant Flow|Parker Flex-Tip® Tracheal Tube|"Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube~Parker Flex-Tip® tracheal tube"
11153039|NCT01894178|FG001|Participant Flow|Portex® Tracheal Tube|"Intubation of obese patients with the Portex® Tracheal Tube~Portex® Tracheal Tube"
11153040|NCT01894178|OG000|Outcome|Parker Flex-Tip® Tracheal Tube|"Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube~Parker Flex-Tip® tracheal tube"
11153041|NCT01894178|OG001|Outcome|Portex® Tracheal Tube|"Intubation of obese patients with the Portex® Tracheal Tube~Portex® Tracheal Tube"
11153042|NCT01894178|EG000|Reported Event|Parker Flex-Tip® Tracheal Tube|"Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube~Parker Flex-Tip® tracheal tube"
11153043|NCT01894178|EG001|Reported Event|Portex® Tracheal Tube|"Intubation of obese patients with the Portex® Tracheal Tube~Portex® Tracheal Tube"
11153044|NCT01894230|BG000|Baseline|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
11153045|NCT01894230|BG001|Baseline|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
11153046|NCT01894230|BG002|Baseline|Total|Total of all reporting groups
11153047|NCT01894230|FG000|Participant Flow|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
11153048|NCT01894230|FG001|Participant Flow|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
11153049|NCT01894230|OG000|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
11153050|NCT01894230|OG001|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
11153051|NCT01894230|EG000|Reported Event|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
11153052|NCT01894230|EG001|Reported Event|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
11153053|NCT01894243|BG000|Baseline|Normal Hepatic Function|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
11153054|NCT01894243|BG001|Baseline|Mild Hepatic Impairment|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
11153055|NCT01894243|BG002|Baseline|Moderate Hepatic Impairment|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
11153056|NCT01894243|BG003|Baseline|Total|Total of all reporting groups
11153057|NCT01894243|FG000|Participant Flow|Normal Hepatic Function|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
11153058|NCT01894243|FG001|Participant Flow|Mild Hepatic Impairment|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
11153059|NCT01894243|FG002|Participant Flow|Moderate Hepatic Impairment|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
11153060|NCT01894243|OG000|Outcome|Normal Hepatic Function|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
11153061|NCT01894243|OG001|Outcome|Mild Hepatic Impairment|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
11153062|NCT01894243|OG002|Outcome|Moderate Hepatic Function|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
11153063|NCT01894243|OG000|Outcome|GLSMean Ratio of Mild to Normal|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild/normal hepatic function
11153064|NCT01894243|OG001|Outcome|GLSMean Ratio of Moderate to Normal|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate/normal hepatic function
11153065|NCT01894243|OG002|Outcome|Moderate Hepatic Impairment|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
11153066|NCT01894243|OG000|Outcome|GLSMean Ration of Mild to Normal|Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild/normal hepatic function
11153067|NCT01894243|EG000|Reported Event|Normal (Part A)|Normal hepatic function (Part A)
11153068|NCT01894243|EG001|Reported Event|Mild (Part A)|Mild hepatic impairment (Part A)
11153069|NCT01894243|EG002|Reported Event|Moderate (Part A)|Moderate hepatic impairment (Part A)
11153070|NCT01894243|EG003|Reported Event|Normal (Part B)|Normal hepatic function
11153071|NCT01894243|EG004|Reported Event|Mild (Part B)|Mild hepatic impairment (Part B)
11153072|NCT01894243|EG005|Reported Event|Moderate (Part B)|Moderate hepatic impairment (Part B)
11153073|NCT01894256|BG000|Baseline|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
11153074|NCT01894256|BG001|Baseline|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153075|NCT01894256|BG002|Baseline|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153076|NCT01894256|BG003|Baseline|Total|Total of all reporting groups
11153077|NCT01894256|FG000|Participant Flow|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
11153078|NCT01894256|FG001|Participant Flow|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153079|NCT01894256|FG002|Participant Flow|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153080|NCT01894256|OG000|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
11153081|NCT01894256|OG001|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153082|NCT01894256|OG002|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153083|NCT01894256|EG000|Reported Event|Part A Normal Renal Function|Patients from Part A of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
11153084|NCT01894256|EG001|Reported Event|Part A Mild Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153085|NCT01894256|EG002|Reported Event|Part A Moderate Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153086|NCT01894256|EG003|Reported Event|Part B Normal Renal Function|Patients in Part B of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
11153087|NCT01894256|EG004|Reported Event|Part B Mild Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153088|NCT01894256|EG005|Reported Event|Part B Moderate Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
11153089|NCT01894477|BG000|Baseline|Arm A (Treosulfan, Fludarabine Phosphate)|Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
11153090|NCT01894477|BG001|Baseline|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
11153091|NCT01894477|BG002|Baseline|Total|Total of all reporting groups
11153092|NCT01894477|FG000|Participant Flow|Arm A (Treosulfan, Fludarabine Phosphate)|"CONDITIONING REGIMEN:~Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.~TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0.~GVHD PROPHYLAXIS: Patients with related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC"
11153093|NCT01894477|FG001|Participant Flow|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|"CONDITIONING REGIMEN: Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.~TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0.~GVHD PROPHYLAXIS: Patients with a related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Fludarabine Phosphate: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant~Total-Body Irradation"
11153094|NCT01894477|OG000|Outcome|Arm A (Treosulfan, Fludarabine Phosphate)|Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
11153095|NCT01894477|OG001|Outcome|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
11153096|NCT01894477|EG000|Reported Event|Arm A (Treosulfan, Fludarabine Phosphate)|Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
11153097|NCT01894477|EG001|Reported Event|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
11153098|NCT01894503|BG000|Baseline|Demographic and Baseline Clinical Characteristics|In-office bilateral placement of two S8 Sinus Implants
11153099|NCT01894503|FG000|Participant Flow|S8 Sinus Implant|Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses S8 Sinus Implant (mometasone furoate, 1350 mcg): Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
11153100|NCT01894503|OG000|Outcome|S8 Sinus Implant|Implant delivery success
11153101|NCT01894503|OG000|Outcome|S8 Sinus Implant|In-office bilateral placement of the S8 Sinus Implant (1350 mcg of mometasone furoate) in the ethmoid sinuses
11153102|NCT01894503|EG000|Reported Event|S8 Sinus Implant|Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses S8 Sinus Implant (mometasone furoate, 1350 mcg): Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
11153103|NCT01894516|BG000|Baseline|Placebo|Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg QD during Weeks 13 to 24.
11153104|NCT01894516|BG001|Baseline|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11153105|NCT01894516|BG002|Baseline|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11153106|NCT01894516|BG003|Baseline|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11153107|NCT01894516|BG004|Baseline|Total|Total of all reporting groups
11153108|NCT01894516|FG000|Participant Flow|Placebo|Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD during Weeks 13 to 24.
11153109|NCT01894516|FG001|Participant Flow|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11153110|NCT01894516|FG002|Participant Flow|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11153111|NCT01894516|FG003|Participant Flow|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11153112|NCT01894516|OG000|Outcome|Placebo|Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.
11153113|NCT01894516|OG001|Outcome|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11153114|NCT01894516|OG002|Outcome|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11153115|NCT01894516|OG003|Outcome|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11153116|NCT01894516|OG000|Outcome|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11153117|NCT01894516|OG001|Outcome|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11153118|NCT01894516|OG002|Outcome|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11153119|NCT01894516|OG000|Outcome|Placebo|Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg QD during Weeks 13 to 24.
11153120|NCT01894516|EG000|Reported Event|Placebo|Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg QD during Weeks 13 to 24.
11153121|NCT01894516|EG001|Reported Event|GLPG0634 50 mg QD|Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
11153122|NCT01894516|EG002|Reported Event|GLPG0634 100 mg QD|Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
11153123|NCT01894516|EG003|Reported Event|GLPG0634 200 mg QD|Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
11153124|NCT01894555|BG000|Baseline|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
11153125|NCT01894555|FG000|Participant Flow|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
11153126|NCT01894555|OG000|Outcome|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
11153127|NCT01894555|EG000|Reported Event|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
11153128|NCT01894568|BG000|Baseline|Insulin Peglispro|Insulin Peglispro administered SC once daily for 26 weeks.
11153129|NCT01894568|BG001|Baseline|Insulin Glargine|Insulin Glargine administered SC once daily for 26 weeks.
11153130|NCT01894568|BG002|Baseline|Total|Total of all reporting groups
11153131|NCT01894568|FG000|Participant Flow|Insulin Peglispro|Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks.
11153132|NCT01894568|FG001|Participant Flow|Insulin Glargine|Insulin Glargine administered SC once daily for 26 weeks.
11153133|NCT01894568|OG000|Outcome|Insulin Peglispro|Insulin Peglispro administered SC once daily for 26 weeks.
11153134|NCT01894568|OG001|Outcome|Insulin Glargine|Insulin Glargine administered SC once daily for 26 weeks.
11153135|NCT01894568|OG000|Outcome|Insulin Peglispro|Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks.
11153136|NCT01894568|EG000|Reported Event|Insulin Peglispro|Insulin Peglispro administered SC once daily for 26 weeks.
11153137|NCT01894568|EG001|Reported Event|Insulin Glargine|Insulin Glargine administered SC once daily for 26 weeks.
11153138|NCT01894581|BG000|Baseline|Obese|BMI >= 30 kg/m2
11153139|NCT01894581|BG001|Baseline|Normal Weight|BMI 18-25 kg/m2
11153140|NCT01894581|BG002|Baseline|Total|Total of all reporting groups
11153141|NCT01894581|FG000|Participant Flow|Obese|BMI >= 30 kg/m2
11153142|NCT01894581|FG001|Participant Flow|Normal Weight|BMI 18-25 kg/m2
11153143|NCT01894581|OG000|Outcome|Obese|BMI >= 30 kg/m2
11153144|NCT01894581|OG001|Outcome|Normal Weight|BMI 18-25 kg/m2
11153145|NCT01894581|EG000|Reported Event|Obese|BMI >= 30 kg/m2
11153146|NCT01894581|EG001|Reported Event|Normal Weight|BMI 18-25 kg/m2
11153147|NCT01894607|BG000|Baseline|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
11153148|NCT01894607|FG000|Participant Flow|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
11153149|NCT01894607|OG000|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
11153150|NCT01894607|EG000|Reported Event|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
11153151|NCT01894620|BG000|Baseline|rTMS Real-sham|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153152|NCT01894620|BG001|Baseline|rTMS Sham-real|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153153|NCT01894620|BG002|Baseline|Total|Total of all reporting groups
11153154|NCT01894620|FG000|Participant Flow|rTMS Real-sham|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153155|NCT01894620|FG001|Participant Flow|rTMS Sham-real|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153156|NCT01894620|OG000|Outcome|rTMS With Sham Coil|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11228127|NCT02388321|EG001|Reported Event|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
11228128|NCT02388347|BG000|Baseline|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
11153157|NCT01894620|OG001|Outcome|rTMS With Real Coil|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153158|NCT01894620|OG000|Outcome|rTMS Real-sham|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153159|NCT01894620|OG001|Outcome|rTMS Sham-real|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153160|NCT01894620|EG000|Reported Event|rTMS With Sham Coil|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153161|NCT01894620|EG001|Reported Event|rTMS With Real Coil|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
11153162|NCT01894672|BG000|Baseline|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
11153163|NCT01894672|FG000|Participant Flow|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
11153164|NCT01894672|OG000|Outcome|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
11153165|NCT01894672|OG000|Outcome|LGX818|"LGX818 capsules will be administered orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.~LGX818"
11153166|NCT01894672|EG000|Reported Event|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
11153167|NCT01894776|BG000|Baseline|Maraviroc|"Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin~Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily~Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily~Rifabutin: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days~Maraviroc: Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days"
11228129|NCT02388347|BG001|Baseline|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
11228130|NCT02388347|BG002|Baseline|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
11153168|NCT01894776|FG000|Participant Flow|Maraviroc|"Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin~Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily~Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily~Rifabutin: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days~Maraviroc: Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days"
11153169|NCT01894776|OG000|Outcome|Maraviroc|"Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin~Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily~Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily~Rifabutin: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days~Maraviroc: Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days"
11153170|NCT01894776|EG000|Reported Event|Maraviroc|"Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin~Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily~Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily~Rifabutin: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days~Maraviroc: Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days"
11153171|NCT01894841|BG000|Baseline|CLASP Intervention + Enhanced Monitoring|"A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.~Plus~Enhanced monitoring consisting of assessment and medical record notes sent to mental health providers."
11153172|NCT01894841|BG001|Baseline|Safety Assessment and Follow up Evaluation + TAU|Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers.
11153173|NCT01894841|BG002|Baseline|Total|Total of all reporting groups
11153174|NCT01894841|FG000|Participant Flow|CLASP Intervention|The Coping Long Term with Active Suicide is a 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.
11153175|NCT01894841|FG001|Participant Flow|Safety Assessment and Follow up Evaluation|"Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers.~Coping Long Term with Active Suicide: an intervention to reduce suicide behavior in Veterans recently hospitalized for suicide attempt or ideation with intent."
11153176|NCT01894841|OG000|Outcome|CLASP Intervention|A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.
11153177|NCT01894841|OG001|Outcome|Safety Assessment and Follow up Evaluation|Treatment as usual plus enhanced monitoring.
11153178|NCT01894841|OG000|Outcome|CLASP Intervention|The Coping Long Term with Active Suicide is a 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.
11153179|NCT01894841|OG001|Outcome|Safety Assessment and Follow up Evaluation|Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers.
11153180|NCT01894841|OG000|Outcome|CLASP Intervention + Enhanced Monitoring|"A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.~Plus~Enhanced monitoring consisting of assessment and medical record notes sent to mental health providers."
11153181|NCT01894841|OG001|Outcome|Safety Assessment and Follow up Evaluation + TAU|Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers.
11153182|NCT01894841|EG000|Reported Event|CLASP Intervention|A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.
11153183|NCT01894841|EG001|Reported Event|Safety Assessment and Follow up Evaluation|Treatment as usual plus enhanced monitoring.
11153184|NCT01894906|BG000|Baseline|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
11153185|NCT01894906|BG001|Baseline|Gambro 17R/21R (Group 2: Polyamide Membrane).|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
11153186|NCT01894906|BG002|Baseline|Total|Total of all reporting groups
11153187|NCT01894906|FG000|Participant Flow|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
11153188|NCT01894906|FG001|Participant Flow|Gambro 17R/21R (Group 2: Polyamide Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
11153189|NCT01894906|OG000|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
11228131|NCT02388347|BG003|Baseline|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
11153190|NCT01894906|OG001|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
11153191|NCT01894906|OG002|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
11153192|NCT01894906|OG003|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
11153193|NCT01894906|OG004|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
11153194|NCT01894906|OG005|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
11153195|NCT01894906|OG000|Outcome|Baxter CT-190|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
11153196|NCT01894906|OG001|Outcome|Gambro Polyflux|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
11153197|NCT01894906|OG002|Outcome|Baxter and Gambro Combined|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). This category includes the combined results of both groups.
11153198|NCT01894906|OG000|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
11153199|NCT01894906|EG000|Reported Event|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
11153200|NCT01894906|EG001|Reported Event|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
11153201|NCT01894906|EG002|Reported Event|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
11153202|NCT01894906|EG003|Reported Event|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
11153203|NCT01894906|EG004|Reported Event|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
11153204|NCT01894906|EG005|Reported Event|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
11153205|NCT01894919|BG000|Baseline|2H3H511_V|In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
11153206|NCT01894919|BG001|Baseline|2H3H511_NV|In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
11153207|NCT01894919|BG002|Baseline|3H5_11_V|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153208|NCT01894919|BG003|Baseline|3H5_11_NV|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
11153209|NCT01894919|BG004|Baseline|68_11_V|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153210|NCT01894919|BG005|Baseline|68_11_NV|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
11153211|NCT01894919|BG006|Baseline|02_2_5_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153212|NCT01894919|BG007|Baseline|02_2_5_NV|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
11153213|NCT01894919|BG008|Baseline|02_6_10_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153214|NCT01894919|BG009|Baseline|02_6_10_NV|In the parent study V72_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
11153215|NCT01894919|BG010|Baseline|NAIVE 123|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153216|NCT01894919|BG011|Baseline|NAIVE_4A|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153217|NCT01894919|BG012|Baseline|NAIVE_4B|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153218|NCT01894919|BG013|Baseline|Total|Total of all reporting groups
11153219|NCT01894919|FG000|Participant Flow|2H3H511_V|In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
11153220|NCT01894919|FG001|Participant Flow|2H3H511_NV|In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
11153221|NCT01894919|FG002|Participant Flow|3H5_11_V|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153222|NCT01894919|FG003|Participant Flow|3H5_11_NV|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
11153223|NCT01894919|FG004|Participant Flow|68_11_V|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153224|NCT01894919|FG005|Participant Flow|68_11_NV|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
11153225|NCT01894919|FG006|Participant Flow|02_2_5_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153226|NCT01894919|FG007|Participant Flow|02_2_5_NV|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
11153227|NCT01894919|FG008|Participant Flow|02_6_10_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153228|NCT01894919|FG009|Participant Flow|02_6_10_NV|In the parent study V72_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
11153229|NCT01894919|FG010|Participant Flow|NAIVE 123|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153230|NCT01894919|FG011|Participant Flow|NAIVE_4A|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153231|NCT01894919|FG012|Participant Flow|NAIVE_4B|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153232|NCT01894919|OG000|Outcome|2H3H511|Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
11153233|NCT01894919|OG001|Outcome|3H5_11|Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
11153234|NCT01894919|OG002|Outcome|68_11|Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
11153235|NCT01894919|OG003|Outcome|NAIVE 123|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153236|NCT01894919|OG004|Outcome|02_2_5|Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).
11153237|NCT01894919|OG005|Outcome|NAIVE_4A|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
11153238|NCT01894919|OG006|Outcome|02_6_10|Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).
11153239|NCT01894919|OG007|Outcome|NAIVE_4B|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
11153240|NCT01894919|OG003|Outcome|NAIVE 123|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
11153241|NCT01894919|OG003|Outcome|02_2_5|Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).
11153242|NCT01894919|OG004|Outcome|02_6_10|Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).
11153243|NCT01894919|OG000|Outcome|02_2_5|Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).
11153244|NCT01894919|OG001|Outcome|02_6_10|Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).
11153245|NCT01894919|OG000|Outcome|2H3H511_V|In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
11153246|NCT01894919|OG001|Outcome|3H5_11_V|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153247|NCT01894919|OG002|Outcome|68_11_V|In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153248|NCT01894919|OG003|Outcome|02_2_5_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153249|NCT01894919|OG004|Outcome|02_6_10_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153250|NCT01894919|OG005|Outcome|NAIVE 123|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153251|NCT01894919|OG006|Outcome|NAIVE_4A|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153252|NCT01894919|OG007|Outcome|NAIVE_4B|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153253|NCT01894919|OG000|Outcome|02_2_5_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153254|NCT01894919|OG001|Outcome|02_6_10_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153255|NCT01894919|OG000|Outcome|2H3H511_V|In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
11153256|NCT01894919|OG001|Outcome|3H5_11_V|In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153257|NCT01894919|OG002|Outcome|68_11_V|In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153258|NCT01894919|OG000|Outcome|NAIVE 123|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153259|NCT01894919|OG001|Outcome|NAIVE_4A|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153260|NCT01894919|OG002|Outcome|NAIVE_4B|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153261|NCT01894919|OG000|Outcome|02_6_10_V|In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153262|NCT01894919|OG000|Outcome|NAIVE_4B|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153263|NCT01894919|OG001|Outcome|3H5_11_V|In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
11153264|NCT01894919|EG000|Reported Event|2H3H511_V|In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
11153265|NCT01894919|EG001|Reported Event|3H5_11_V|In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153266|NCT01894919|EG002|Reported Event|68_11_V|In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
11153267|NCT01894919|EG003|Reported Event|02_2_5_V|In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153268|NCT01894919|EG004|Reported Event|02_6_10_V|In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
11153269|NCT01894919|EG005|Reported Event|NAIVE 123|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153270|NCT01894919|EG006|Reported Event|NAIVE_4A|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153271|NCT01894919|EG007|Reported Event|NAIVE_4B|Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
11153272|NCT01894984|BG000|Baseline|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
11153273|NCT01894984|BG001|Baseline|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
11153274|NCT01894984|BG002|Baseline|Total|Total of all reporting groups
11153275|NCT01894984|FG000|Participant Flow|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
11153276|NCT01894984|FG001|Participant Flow|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
11153277|NCT01894984|OG000|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
11153278|NCT01894984|OG001|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
11153279|NCT01894984|EG000|Reported Event|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
11153280|NCT01894984|EG001|Reported Event|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
11153281|NCT01895036|BG000|Baseline|Naltrexone|"PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone~Naltrexone"
11153282|NCT01895036|FG000|Participant Flow|Naltrexone|"PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone~Naltrexone"
11153283|NCT01895036|OG000|Outcome|Naltrexone|"PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone~Naltrexone"
11153284|NCT01895036|EG000|Reported Event|Naltrexone|"PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone~Naltrexone"
11153285|NCT01895062|BG000|Baseline|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
11153286|NCT01895062|BG001|Baseline|no Intervention|Routine care is administered without the application of cNEP.
11153287|NCT01895062|BG002|Baseline|Total|Total of all reporting groups
11153288|NCT01895062|FG000|Participant Flow|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
11153289|NCT01895062|FG001|Participant Flow|no Intervention|Routine care is administered without the application of cNEP.
11153290|NCT01895062|OG000|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
11153291|NCT01895062|OG001|Outcome|no Intervention|Routine care is administered without the application of cNEP.
11153292|NCT01895062|EG000|Reported Event|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
11153293|NCT01895062|EG001|Reported Event|no Intervention|Routine care is administered without the application of cNEP.
11153294|NCT01895088|BG000|Baseline|Age, Categorical|Measure Type: Count of Participants
11153295|NCT01895088|FG000|Participant Flow|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study~AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay"
11153296|NCT01895088|OG000|Outcome|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study~AcuFocus Corneal Inlay ACI 7000 PDT: Inlay implanted in cornea for improvement of near vision"
11153297|NCT01895088|EG000|Reported Event|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study~AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay"
11153298|NCT01895101|BG000|Baseline|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
11153299|NCT01895101|BG001|Baseline|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
11153300|NCT01895101|BG002|Baseline|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
11153301|NCT01895101|BG003|Baseline|Total|Total of all reporting groups
11153302|NCT01895101|FG000|Participant Flow|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
11153303|NCT01895101|FG001|Participant Flow|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
11153304|NCT01895101|FG002|Participant Flow|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
11153305|NCT01895101|OG000|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
11153306|NCT01895101|OG001|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
11153307|NCT01895101|OG002|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
11153308|NCT01895101|EG000|Reported Event|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
11153309|NCT01895101|EG001|Reported Event|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
11153310|NCT01895101|EG002|Reported Event|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
11153311|NCT01895127|BG000|Baseline|Standard of Care|"Plasmapheresis (PP) x 3, at 40-60 cc/kg.~Immunoglobulin (IVIg), to be administered after each PP~Immunoglobulin~Plasmapheresis"
11153312|NCT01895127|BG001|Baseline|Soliris (Eculizumab)|"1200 mg first dose (Time: Screening/Week 0, after Biopsy Proven AMR)~900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)~1200 mg week 5~Week 6: If donor specific antibody < 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9~Eculizumab"
11153313|NCT01895127|BG002|Baseline|Total|Total of all reporting groups
11153314|NCT01895127|FG000|Participant Flow|Standard of Care|"Plasmapheresis (PP) x 3, at 40-60 cc/kg.~Immunoglobulin (IVIg), to be administered after each PP~Immunoglobulin~Plasmapheresis"
11153315|NCT01895127|FG001|Participant Flow|Soliris (Eculizumab)|"1200 mg first dose (Time: Screening/Week 0, after Biopsy Proven AMR)~900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)~1200 mg week 5~Week 6: If donor specific antibody < 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9~Eculizumab"
11153316|NCT01895127|OG000|Outcome|Standard of Care|"Plasmapheresis (PP) x 3, at 40-60 cc/kg.~Immunoglobulin (IVIg), to be administered after each PP~Immunoglobulin~Plasmapheresis"
11153317|NCT01895127|OG001|Outcome|Soliris (Eculizumab)|"1200 mg first dose (Time: Screening/Week 0, after Biopsy Proven AMR)~900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)~1200 mg week 5~Week 6: If donor specific antibody < 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9~Eculizumab"
11153318|NCT01895127|OG002|Outcome|Standard of Care + Soliris (Eculizumab)|Subjects received both standard of care and Soliris treatment between Week 0 and Month 3
11153319|NCT01895127|EG000|Reported Event|Standard of Care|"Plasmapheresis (PP) x 3, at 40-60 cc/kg.~Immunoglobulin (IVIg), to be administered after each PP~Immunoglobulin~Plasmapheresis"
11153320|NCT01895127|EG001|Reported Event|Soliris (Eculizumab)|"1200 mg first dose (Time: Screening/Week 0, after Biopsy Proven AMR)~900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)~1200 mg week 5~Week 6: If donor specific antibody < 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9~Eculizumab"
11153321|NCT01895270|BG000|Baseline|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3-5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
11153322|NCT01895270|BG001|Baseline|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
11153323|NCT01895270|BG002|Baseline|Total|Total of all reporting groups
11153324|NCT01895270|FG000|Participant Flow|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3-5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
11153325|NCT01895270|FG001|Participant Flow|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
11153326|NCT01895270|OG000|Outcome|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3-5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
11228132|NCT02388347|BG004|Baseline|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
11228133|NCT02388347|BG005|Baseline|Total|Total of all reporting groups
11153327|NCT01895270|OG001|Outcome|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
11153328|NCT01895270|EG000|Reported Event|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3-5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
11153329|NCT01895270|EG001|Reported Event|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
11153330|NCT01895309|BG000|Baseline|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
11153331|NCT01895309|BG001|Baseline|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
11153332|NCT01895309|BG002|Baseline|Total|Total of all reporting groups
11153333|NCT01895309|FG000|Participant Flow|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
11153334|NCT01895309|FG001|Participant Flow|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
11153335|NCT01895309|OG000|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
11153336|NCT01895309|OG001|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
11153337|NCT01895309|OG000|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 24|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
11153338|NCT01895309|OG001|Outcome|Enbrel (Etanercept) at Week 24|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
11153339|NCT01895309|OG002|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 52|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
11153340|NCT01895309|OG003|Outcome|Enbrel (Etanercept) at Week 52|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
11153341|NCT01895309|EG000|Reported Event|SB4 (Proposed Biosimilar to Etanercept)|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
11153342|NCT01895309|EG001|Reported Event|Enbrel (Etanercept)|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
11153343|NCT01895322|BG000|Baseline|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
11153344|NCT01895322|FG000|Participant Flow|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
11153345|NCT01895322|OG000|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
11153346|NCT01895322|OG000|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an increase of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
11153347|NCT01895322|EG000|Reported Event|OPC-41061|OPC-41061
11153348|NCT01895335|BG000|Baseline|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
11153349|NCT01895335|FG000|Participant Flow|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
11153350|NCT01895335|OG000|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
11153351|NCT01895335|EG000|Reported Event|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
11153352|NCT01895361|BG000|Baseline|High-dose SelG1 (Selg1 5.0 mg/kg)|"IV Infusion, once every 4 weeks through Week 50~SelG1"
11153353|NCT01895361|BG001|Baseline|Low-dose SelG1 (Selg1 2.5 mg/kg)|"IV Infusion, once every 4 weeks through Week 50~SelG1"
11153354|NCT01895361|BG002|Baseline|Placebo|"IV Infusion, once every 4 weeks through Week 50~Placebo"
11153355|NCT01895361|BG003|Baseline|Total|Total of all reporting groups
11153356|NCT01895361|FG000|Participant Flow|High-dose SelG1 (Selg1 5.0 mg/kg)|"IV Infusion, once every 4 weeks through Week 50~SelG1"
11153357|NCT01895361|FG001|Participant Flow|Low-dose SelG1 (Selg1 2.5 mg/kg)|"IV Infusion, once every 4 weeks through Week 50~SelG1"
11153358|NCT01895361|FG002|Participant Flow|Placebo|"IV Infusion, once every 4 weeks through Week 50~Placebo"
11153359|NCT01895361|OG000|Outcome|High-dose SelG1 (Selg1 5.0 mg/kg)|"IV Infusion, once every 4 weeks through Week 50~SelG1"
11153360|NCT01895361|OG001|Outcome|Low-dose SelG1 (Selg1 2.5 mg/kg)|"IV Infusion, once every 4 weeks through Week 50~SelG1"
11153361|NCT01895361|OG002|Outcome|Placebo|"IV Infusion, once every 4 weeks through Week 50~Placebo"
11153362|NCT01895361|EG000|Reported Event|High-dose SelG1 (5.0 mg/kg SelG1)|IV Infusion, once every 4 weeks through Week 50
11153363|NCT01895361|EG001|Reported Event|Low-dose SelG1 (2.5 mg/kg SelG10|IV Infusion, once every 4 weeks through Week 50
11153364|NCT01895361|EG002|Reported Event|Placebo|IV Infusion, once every 4 weeks through Week 50
11153365|NCT01895452|BG000|Baseline|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
11153366|NCT01895452|BG001|Baseline|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
11153367|NCT01895452|BG002|Baseline|Total|Total of all reporting groups
11153368|NCT01895452|FG000|Participant Flow|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
11153369|NCT01895452|FG001|Participant Flow|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
11153370|NCT01895452|OG000|Outcome|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
11153371|NCT01895452|OG001|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
11153372|NCT01895452|EG000|Reported Event|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
11153373|NCT01895452|EG001|Reported Event|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
11153374|NCT01895543|BG000|Baseline|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
11153375|NCT01895543|FG000|Participant Flow|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
11153376|NCT01895543|OG000|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
11153377|NCT01895543|EG000|Reported Event|EBX 10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
11153378|NCT01895608|BG000|Baseline|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
11153379|NCT01895608|BG001|Baseline|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
11153380|NCT01895608|BG002|Baseline|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
11153381|NCT01895608|BG003|Baseline|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
11153382|NCT01895608|BG004|Baseline|Total|Total of all reporting groups
11153383|NCT01895608|FG000|Participant Flow|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
11153384|NCT01895608|FG001|Participant Flow|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
11228134|NCT02388347|FG000|Participant Flow|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
11228135|NCT02388347|FG001|Participant Flow|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
11153385|NCT01895608|FG002|Participant Flow|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
11153386|NCT01895608|FG003|Participant Flow|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
11153387|NCT01895608|OG000|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
11153388|NCT01895608|OG001|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
11153389|NCT01895608|OG002|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
11153390|NCT01895608|OG003|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
11153391|NCT01895608|EG000|Reported Event|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
11153392|NCT01895608|EG001|Reported Event|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
11153393|NCT01895608|EG002|Reported Event|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
11153394|NCT01895608|EG003|Reported Event|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
11153395|NCT01895634|BG000|Baseline|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
11153396|NCT01895634|FG000|Participant Flow|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
11153397|NCT01895634|OG000|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
11153398|NCT01895634|EG000|Reported Event|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
11153399|NCT01895647|BG000|Baseline|Biceps Stimulation|"EMS~EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes"
11153400|NCT01895647|BG001|Baseline|Quadriceps Stimulation|"EMS~EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes"
11153401|NCT01895647|BG002|Baseline|Control|Control group without electric muscle stimulation
11153402|NCT01895647|BG003|Baseline|Total|Total of all reporting groups
11153403|NCT01895647|FG000|Participant Flow|Biceps Stimulation|"EMS~EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes"
11153404|NCT01895647|FG001|Participant Flow|Quadriceps Stimulation|"EMS~EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes"
11153405|NCT01895647|FG002|Participant Flow|Control|Control group without electric muscle stimulation
11153406|NCT01895647|OG000|Outcome|Biceps Stimulation|"EMS~EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes"
11153407|NCT01895647|OG001|Outcome|Quadriceps Stimulation|"EMS~EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes"
11153408|NCT01895647|OG002|Outcome|Control|Control group without electric muscle stimulation
11153409|NCT01895647|EG000|Reported Event|Biceps Stimulation|"EMS~EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes"
11153410|NCT01895647|EG001|Reported Event|Quadriceps Stimulation|"EMS~EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes"
11153411|NCT01895647|EG002|Reported Event|Control|Control group without electric muscle stimulation
11153412|NCT01895777|BG000|Baseline|Dabigatran Etexilate|Oral administration of dabigatran etexilate (DE) twice daily. Patients aged ≥8 years: age- and weight-adjusted DE dosing via capsules using 50 milligram (mg), 75 mg, 110 mg, and 150 mg capsules. Patients aged <8 years or for patients who cannot take capsules even if older than 8 (but <12 years of age): age- and weight-adjusted dosing via DE pellets. Patients aged <12 months: age- and weight-adjusted dosing via DE oral liquid formulation (OLF).
11153413|NCT01895777|BG001|Baseline|Standard of Care|Investigators decided on SoC treatment at time of randomisation: either low molecular weight heparin (LMWH) or vitamin K antagonists (VKA) or fondaparinux.
11153414|NCT01895777|BG002|Baseline|Total|Total of all reporting groups
11153415|NCT01895777|FG000|Participant Flow|Dabigatran Etexilate|Oral administration of dabigatran etexilate (DE) twice daily. Patients aged ≥8 years: age- and weight-adjusted DE dosing via capsules using 50 milligram (mg), 75 mg, 110 mg, and 150 mg capsules. Patients aged <8 years or for patients who cannot take capsules even if older than 8 (but <12 years of age): age- and weight-adjusted dosing via DE pellets. Patients aged <12 months: age- and weight-adjusted dosing via DE oral liquid formulation (OLF).
11153416|NCT01895777|FG001|Participant Flow|Standard of Care|Investigators decided on SoC treatment at time of randomisation: either low molecular weight heparin (LMWH) or vitamin K antagonists (VKA) or fondaparinux.
11153417|NCT01895777|OG000|Outcome|Dabigatran Etexilate|Oral administration of dabigatran etexilate (DE) twice daily. Patients aged ≥8 years: age- and weight-adjusted DE dosing via capsules using 50 milligram (mg), 75 mg, 110 mg, and 150 mg capsules. Patients aged <8 years or for patients who cannot take capsules even if older than 8 (but <12 years of age): age- and weight-adjusted dosing via DE pellets. Patients aged <12 months: age- and weight-adjusted dosing via DE oral liquid formulation (OLF).
11153418|NCT01895777|OG001|Outcome|Standard of Care|Investigators decided on SoC treatment at time of randomisation: either low molecular weight heparin (LMWH) or vitamin K antagonists (VKA) or fondaparinux.
11153419|NCT01895777|OG000|Outcome|Dabigatran Etexilate|Oral administration of dabigatran etexilate (DE) twice daily. Patients aged ≥8 years: age- and weight-adjusted DE dosing via capsules using 50 milligram (mg), 75 mg, 110 mg, and 150 mg capsules.
11153420|NCT01895777|OG000|Outcome|Dabigatran Etexilate|Oral administration of dabigatran etexilate (DE) twice daily. Patients aged <8 years or for patients who cannot take capsules even if older than 8 (but <12 years of age): age- and weight-adjusted dosing via DE pellets.
11153421|NCT01895777|OG000|Outcome|Dabigatran Etexilate|Oral administration of dabigatran etexilate (DE) twice daily. Patients aged <12 months: age- and weight-adjusted dosing via DE oral liquid formulation (OLF).
11153422|NCT01895777|EG000|Reported Event|Dabigatran Etexilate|Oral administration of dabigatran etexilate (DE) twice daily. Patients aged ≥8 years: age- and weight-adjusted DE dosing via capsules using 50 milligram (mg), 75 mg, 110 mg, and 150 mg capsules. Patients aged <8 years or for patients who cannot take capsules even if older than 8 (but <12 years of age): age- and weight-adjusted dosing via DE pellets. Patients aged <12 months: age- and weight-adjusted dosing via DE oral liquid formulation (OLF).
11153423|NCT01895777|EG001|Reported Event|Standard of Care|Investigators decided on SoC treatment at time of randomisation: either low molecular weight heparin (LMWH) or vitamin K antagonists (VKA) or fondaparinux.
11153424|NCT01895855|BG000|Baseline|PXVX0200|Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x10^8 to 2x10^9 CFU in a liquid suspension
11153425|NCT01895855|BG001|Baseline|Placebo|Biological: Placebo physiological saline
11153426|NCT01895855|BG002|Baseline|Total|Total of all reporting groups
11153427|NCT01895855|FG000|Participant Flow|PXVX0200|Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x10^8 to 2x10^9 CFU in a liquid suspension
11153428|NCT01895855|FG001|Participant Flow|Placebo|Biological: Placebo physiological saline
11153429|NCT01895855|OG000|Outcome|PXVX0200|"Biological: PXVX0200~Single dose; liquid suspension after reconstitution with buffer; 5x10^8 CFU"
11153430|NCT01895855|OG001|Outcome|Placebo|Biological: Placebo physiological saline
11153431|NCT01895855|OG000|Outcome|PXVX0200|Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x10^8 to 2x10^9 CFU in a liquid suspension
11153432|NCT01895855|OG000|Outcome|PXVX0200|Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10^8 CFU
11153433|NCT01895855|OG000|Outcome|PVXV0200|Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
11153434|NCT01895855|OG000|Outcome|PVXV0200|Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x10^8 to 2x10^9 CFU in a liquid suspension
11153435|NCT01895855|EG000|Reported Event|PVXV0200|"Biological: PXVX0200~Single dose; liquid suspension after reconstitution with buffer; 5x10^8 CFU."
11153436|NCT01895855|EG001|Reported Event|Placebo|Biological: Placebo physiological saline
11153437|NCT01895946|BG000|Baseline|Part A|Part A of the study
11153438|NCT01895946|BG001|Baseline|Part B|Part B of the study
11153439|NCT01895946|BG002|Baseline|Total|Total of all reporting groups
11153440|NCT01895946|FG000|Participant Flow|Part A|Part A of the study
11153441|NCT01895946|FG001|Participant Flow|Part B|Part B of the study
11153442|NCT01895946|OG000|Outcome|Part A|Part A of the study
11153443|NCT01895946|OG001|Outcome|Part B|Part B of the study
11153444|NCT01895946|EG000|Reported Event|Part A|Part A of the study
11153445|NCT01895946|EG001|Reported Event|Part B|Part B of the study
11153446|NCT01895972|BG000|Baseline|Latanoprostene Bunod|"Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.~Latanoprostene bunod"
11153447|NCT01895972|FG000|Participant Flow|Latanoprostene Bunod|"Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.~Latanoprostene bunod"
11153448|NCT01895972|OG000|Outcome|Latanoprostene Bunod|"Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.~Latanoprostene bunod"
11153449|NCT01895972|EG000|Reported Event|Latanoprostene Bunod|"Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.~Latanoprostene bunod"
11153450|NCT01896050|BG000|Baseline|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
11153451|NCT01896050|BG001|Baseline|Tamoxifen|Subjects who started treatment with tamoxifen
11153452|NCT01896050|BG002|Baseline|Total|Total of all reporting groups
11153453|NCT01896050|FG000|Participant Flow|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
11153454|NCT01896050|FG001|Participant Flow|Tamoxifen|Subjects who started treatment with tamoxifen
11153455|NCT01896050|OG000|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
11153456|NCT01896050|OG001|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
11153457|NCT01896050|OG000|Outcome|Aromatase Inhibitor|Aromatase inhibitor-treated patients
11153458|NCT01896050|OG001|Outcome|Tamoxifen|Tamoxifen-treated patients
11153459|NCT01896050|EG000|Reported Event|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
11153460|NCT01896050|EG001|Reported Event|Tamoxifen|Subjects who started treatment with tamoxifen
11153461|NCT01896115|BG000|Baseline|All Arms (Phase 1)|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
11153462|NCT01896115|BG001|Baseline|All Arms (Phase 2)|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
11153463|NCT01896115|BG002|Baseline|Total|Total of all reporting groups
11153464|NCT01896115|FG000|Participant Flow|All Arms (Phase 1)|"Patients with a Vercise DBS system programmed to 30 microseconds pulse width~Patients with a Vercise DBS system programmed to 60 microseconds pulse width~Patients with a Vercise DBS system programmed to steer current ventrally~Patients with a Vercise DBS system programmed to steer current dorsally."
11153465|NCT01896115|FG001|Participant Flow|All Arms (Phase 2)|"Patients with a Vercise DBS system programmed to 30 microseconds pulse width~Patients with a Vercise DBS system programmed to 60 microseconds pulse width~Patients with a Vercise DBS system programmed to steer current~Patients with a Vercise DBS system programmed to single contact stimulation"
11153466|NCT01896115|OG000|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
11153467|NCT01896115|OG001|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
11153468|NCT01896115|OG000|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
11153469|NCT01896115|OG001|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
11153470|NCT01896115|OG000|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
11153471|NCT01896115|OG001|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
11153472|NCT01896115|OG002|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
11153473|NCT01896115|OG003|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
11153474|NCT01896115|EG000|Reported Event|All Arms|"Patients with a Vercise DBS system programmed to 4 different settings including:~Short pulse widths (30 microseconds)~Conventional pulse widths (60 microseconds)~Steering current ventrally~Steering current dorsally"
11153475|NCT01896128|BG000|Baseline|Armodafinil|"150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days~Armodafinil"
11153476|NCT01896128|BG001|Baseline|Placebo|"inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days~Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet"
11153477|NCT01896128|BG002|Baseline|Total|Total of all reporting groups
11153478|NCT01896128|FG000|Participant Flow|Armodafinil|"150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days~Armodafinil"
11153479|NCT01896128|FG001|Participant Flow|Placebo|"inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days~Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet"
11153480|NCT01896128|OG000|Outcome|Armodafinil|"150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days~Armodafinil"
11153481|NCT01896128|OG001|Outcome|Placebo|"inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days~Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet"
11153482|NCT01896128|EG000|Reported Event|Armodafinil|"150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days~Armodafinil"
11153483|NCT01896128|EG001|Reported Event|Placebo|"inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days~Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet"
11153484|NCT01896193|BG000|Baseline|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
11153485|NCT01896193|BG001|Baseline|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
11153486|NCT01896193|BG002|Baseline|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
11153487|NCT01896193|BG003|Baseline|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
11153488|NCT01896193|BG004|Baseline|Total|Total of all reporting groups
11153489|NCT01896193|FG000|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks
11153490|NCT01896193|FG001|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11153491|NCT01896193|OG000|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
11153492|NCT01896193|OG001|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
11153493|NCT01896193|OG002|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
11153494|NCT01896193|OG003|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
11153495|NCT01896193|EG000|Reported Event|SOF+RBV 16 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks
11153496|NCT01896193|EG001|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
11153497|NCT01896206|BG000|Baseline|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
11153498|NCT01896206|FG000|Participant Flow|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
11153499|NCT01896206|OG000|Outcome|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
11153500|NCT01896206|EG000|Reported Event|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
11153501|NCT01896232|BG000|Baseline|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
11153502|NCT01896232|BG001|Baseline|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11153503|NCT01896232|BG002|Baseline|Total|Total of all reporting groups
11153504|NCT01896232|FG000|Participant Flow|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
11153505|NCT01896232|FG001|Participant Flow|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11153506|NCT01896232|OG000|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
11153507|NCT01896232|OG001|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11153508|NCT01896232|EG000|Reported Event|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
11153509|NCT01896232|EG001|Reported Event|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11153510|NCT01896271|BG000|Baseline|Treatment|"HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.~IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion~Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions"
11153511|NCT01896271|FG000|Participant Flow|Treatment|"HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.~IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion~Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions"
11153512|NCT01896271|OG000|Outcome|Treatment|"HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.~IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion~Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions"
11153513|NCT01896271|EG000|Reported Event|Treatment|"HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.~IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion~Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions"
11153514|NCT01896297|BG000|Baseline|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
11153515|NCT01896297|FG000|Participant Flow|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
11153516|NCT01896297|OG000|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
11153517|NCT01896297|EG000|Reported Event|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
11153518|NCT01896544|BG000|Baseline|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
11153519|NCT01896544|BG001|Baseline|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
11153520|NCT01896544|BG002|Baseline|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
11153521|NCT01896544|BG003|Baseline|Total|Total of all reporting groups
11153522|NCT01896544|FG000|Participant Flow|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
11153523|NCT01896544|FG001|Participant Flow|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
11153524|NCT01896544|FG002|Participant Flow|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
11153525|NCT01896544|OG000|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
11153526|NCT01896544|OG001|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
11153527|NCT01896544|OG002|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
10851398|NCT00306202|OG001|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m^2, as long as clinical benefit was maintained.
11153528|NCT01896544|OG000|Outcome|Placebo|Oral suspension of placebo cholecalciferol
11153529|NCT01896544|OG001|Outcome|Cholecalciferol Dose 1|Oral suspension cholecalciferol 200,000 IU
11153530|NCT01896544|OG002|Outcome|Cholecalciferol Dose 2|Oral suspension of cholecalciferol 400,000 IU
11153531|NCT01896544|EG000|Reported Event|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
11153532|NCT01896544|EG001|Reported Event|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
11153533|NCT01896544|EG002|Reported Event|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
11153534|NCT01896557|BG000|Baseline|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
11153535|NCT01896557|BG001|Baseline|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
11153536|NCT01896557|BG002|Baseline|Total|Total of all reporting groups
11153537|NCT01896557|FG000|Participant Flow|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
11153538|NCT01896557|FG001|Participant Flow|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
11153539|NCT01896557|OG000|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
11153540|NCT01896557|OG001|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
11153541|NCT01896557|EG000|Reported Event|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
11153542|NCT01896557|EG001|Reported Event|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
11153543|NCT01896687|BG000|Baseline|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
11153544|NCT01896687|BG001|Baseline|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
11153545|NCT01896687|BG002|Baseline|Total|Total of all reporting groups
11153546|NCT01896687|FG000|Participant Flow|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
11153547|NCT01896687|FG001|Participant Flow|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
11153548|NCT01896687|OG000|Outcome|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
11153549|NCT01896687|OG001|Outcome|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
11153550|NCT01896687|EG000|Reported Event|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
11153551|NCT01896687|EG001|Reported Event|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
11153552|NCT01896700|BG000|Baseline|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
11153553|NCT01896700|BG001|Baseline|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
11153554|NCT01896700|BG002|Baseline|Total|Total of all reporting groups
11153555|NCT01896700|FG000|Participant Flow|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
11153556|NCT01896700|FG001|Participant Flow|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
11153557|NCT01896700|OG000|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
11153558|NCT01896700|OG001|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
11153559|NCT01896700|EG000|Reported Event|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
11153560|NCT01896700|EG001|Reported Event|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
11153561|NCT01896726|BG000|Baseline|Baricitinib + Microgynon|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Days 1 and 29. 10 mg baricitinib tablet administered orally, QD, on Days 23 through 30.
11153562|NCT01896726|FG000|Participant Flow|Baricitinib + Microgynon|Microgynon tablet [30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel] administered orally, once daily (QD), on Days 1 and 29. 10 milligrams (mg) baricitinib tablet administered orally, QD, on Days 23 through 30.
11153563|NCT01896726|OG000|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
11153564|NCT01896726|OG001|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
11153565|NCT01896726|EG000|Reported Event|Microgynon Alone|"Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1.~Adverse events are reported from baseline through predose on Day 23."
11153566|NCT01896726|EG001|Reported Event|Baricitinib|"10 mg baricitinib tablet administered orally, QD, on Days 23 through 28.~Adverse events are reported from postdose on Day 23 through predose on Day 29."
11153567|NCT01896726|EG002|Reported Event|Baricitinib + Microgynon|"10 mg baricitinib tablet administered orally, QD, on Days 29 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.~Adverse events are reported from postdose on Day 29 up to Day 40."
11153568|NCT01896856|BG000|Baseline|Phase 1: Dose Level 1|Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.
11153569|NCT01896856|BG001|Baseline|Phase 1: Dose Level -1|Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.
11153570|NCT01896856|BG002|Baseline|Phase 1: Dose Level -1G|"Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.~Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond."
11153571|NCT01896856|BG003|Baseline|Phase 1: Dose Level 1G|"Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.~Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond."
11153572|NCT01896856|BG004|Baseline|Phase 2: Arm A SGI-110 + Irinotecan|SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.
11153573|NCT01896856|BG005|Baseline|Phase 2: Arm B Regorafenib or TAS-102|"Subjects received either regorafenib or TAS-102. Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle.~Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient."
11153574|NCT01896856|BG006|Baseline|Total|Total of all reporting groups
11153575|NCT01896856|FG000|Participant Flow|Phase 1: Dose Level 1|Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.
11153576|NCT01896856|FG001|Participant Flow|Phase 1: Dose Level -1|Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.
11153577|NCT01896856|FG002|Participant Flow|Phase 1: Dose Level -1G|"Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.~Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond."
11228136|NCT02388347|FG002|Participant Flow|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
11153578|NCT01896856|FG003|Participant Flow|Phase 1: Dose Level 1G|"Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.~Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond."
11153579|NCT01896856|FG004|Participant Flow|Phase 2: Arm A SGI-110 + Irinotecan|SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.
11153580|NCT01896856|FG005|Participant Flow|Phase 2: Arm B Regorafenib or TAS-102|"Subjects received either regorafenib or Lonsurf (TAS-102). Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle.~Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient."
11153581|NCT01896856|OG000|Outcome|Dose Level 1|SGI-110 45 mg/m^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m^2 IV on days 8 and 15 of each 28-day cycle.
11153582|NCT01896856|OG001|Outcome|Dose Level -1|SGI-110 30 mg/m^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m^2 IV on days 8 and 15 of each 28-day cycle.
11153583|NCT01896856|OG002|Outcome|Dose Level -1G|SGI-110 30 mg/m^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.
11153584|NCT01896856|OG003|Outcome|Dose Level 1G|SGI-110 45 mg/m^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.
11153585|NCT01896856|OG000|Outcome|Phase 2: Arm A SGI-110 + Irinotecan|SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.
11153586|NCT01896856|OG001|Outcome|Phase 2: Arm B Regorafenib or TAS-102|"Subjects received either regorafenib or TAS-102. Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle.~Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient."
11153587|NCT01896856|EG000|Reported Event|Phase 1: Dose Level 1|Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.
11153588|NCT01896856|EG001|Reported Event|Phase 1: Dose Level -1|Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.
11153589|NCT01896856|EG002|Reported Event|Phase 1: Dose Level -1G|"Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.~Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond."
11153590|NCT01896856|EG003|Reported Event|Phase 1: Dose Level 1G|"Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.~Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond."
11153591|NCT01896856|EG004|Reported Event|Phase 2: Arm A SGI-110 + Irinotecan|"SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle.~Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement."
11153592|NCT01896856|EG005|Reported Event|"Phase 2: Crossover to Arm A From Arm B"|"Per protocol, Arm B subjects were given the option to crossover and receive Arm A study drugs after disease progression on Arm B.~18 Arm B subjects received Arm A study drugs after initial progression.~SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement."
11153593|NCT01896856|EG006|Reported Event|Phase 2: Arm B Regorafenib or TAS-102|"Subjects received either regorafenib or TAS-102. Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle.~Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient."
11153594|NCT01896869|BG000|Baseline|Ipilimumab + Vaccine|"Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.~Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)~Vaccine: 5x10^8 cells administered in 6 intradermal injections"
11153595|NCT01896869|BG001|Baseline|FOLFIRINOX|"Administered every 14 days (one cycle)~FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle."
11153596|NCT01896869|BG002|Baseline|Total|Total of all reporting groups
11153597|NCT01896869|FG000|Participant Flow|Ipilimumab + Vaccine|"Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.~Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)~Vaccine: 5x10^8 cells administered in 6 intradermal injections"
11153598|NCT01896869|FG001|Participant Flow|FOLFIRINOX|"Administered every 14 days (one cycle)~FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle."
11153599|NCT01896869|OG000|Outcome|Ipilimumab + Vaccine|"Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.~Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)~Vaccine: 5x10^8 cells administered in 6 intradermal injections"
11153600|NCT01896869|OG001|Outcome|FOLFIRINOX|"Administered every 14 days (one cycle)~FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle."
11153601|NCT01896869|OG000|Outcome|3 mg/kg|"Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.~Ipilimumab: 3 mg/kg administered IV~Vaccine: 5x10^8 cells administered in 6 intradermal injections"
11153602|NCT01896869|OG001|Outcome|10 mg/kg|"Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.~Ipilimumab: 10 mg/kg administered IV~Vaccine: 5x10^8 cells administered in 6 intradermal injections"
11153603|NCT01896869|OG000|Outcome|Ipilimumab + Vaccine|"Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.~Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)~Vaccine: 5x10^8 cells administered in 6 intradermal injections"
11153604|NCT01896869|EG000|Reported Event|Ipilimumab + Vaccine|"Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.~Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)~Vaccine: 5x10^8 cells administered in 6 intradermal injections"
11153605|NCT01896895|BG000|Baseline|Double-blind MP: Placebo|Participants received 1.0 mL placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153606|NCT01896895|BG001|Baseline|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153607|NCT01896895|BG002|Baseline|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153608|NCT01896895|BG003|Baseline|Total|Total of all reporting groups
11153609|NCT01896895|FG000|Participant Flow|Double-blind MP: Placebo|Participants received 1.0 milliliter (mL) placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153610|NCT01896895|FG001|Participant Flow|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153611|NCT01896895|FG002|Participant Flow|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153612|NCT01896895|FG003|Participant Flow|OLEX: IncobotulinumtoxinA 70 Units|Participants received up to 1.4 mL of incobotulinumtoxinA containing up to 70 units per injection session (35 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the OLEX Period.
11153613|NCT01896895|OG000|Outcome|Double-blind MP: Placebo|Participants received 1.0 mL placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153614|NCT01896895|OG001|Outcome|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153615|NCT01896895|OG002|Outcome|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153616|NCT01896895|EG000|Reported Event|Double-blind MP: Placebo|Participants received 1.0 mL placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153617|NCT01896895|EG001|Reported Event|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153618|NCT01896895|EG002|Reported Event|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
11153619|NCT01896895|EG003|Reported Event|OLEX: IncobotulinumtoxinA 70 Units|Participants received up to 1.4 mL of incobotulinumtoxinA containing up to 70 units per injection session (35 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the OLEX Period.
11153620|NCT01896921|BG000|Baseline|Maraviroc + Raltegravir or Dolutegravir|"Maraviroc 300 mg tablet twice a day plus Raltegravir 400 mg tablet twice a day or Dolutegravir 50 mg tablet once a day for 48 weeks~Switch to Maraviroc + Raltegravir or Dolutegravir: Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks"
11153621|NCT01896921|FG000|Participant Flow|Maraviroc + Raltegravir or Dolutegravir|"Maraviroc 300 mg tablet twice a day plus Raltegravir 400 mg tablet twice a day or Dolutegravir 50 mg tablet once a day for 48 weeks~Switch to Maraviroc + Raltegravir or Dolutegravir: Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks"
11153622|NCT01896921|OG000|Outcome|Maraviroc + Raltegravir or Dolutegravir|"Maraviroc 300 mg tablet twice a day plus Raltegravir 400 mg tablet twice a day or Dolutegravir 50 mg tablet once a day for 48 weeks~Switch to Maraviroc + Raltegravir or Dolutegravir: Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks"
11153623|NCT01896921|EG000|Reported Event|Maraviroc + Raltegravir or Dolutegravir|"Maraviroc 300 mg tablet twice a day plus Raltegravir 400 mg tablet twice a day or Dolutegravir 50 mg tablet once a day for 48 weeks~Switch to Maraviroc + Raltegravir or Dolutegravir: Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks"
11153624|NCT01896934|BG000|Baseline|Sertraline|50-200mg daily
11153625|NCT01896934|FG000|Participant Flow|Sertraline|"50-200mg daily~Sertraline: 50-200mg daily"
11153626|NCT01896934|OG000|Outcome|Sertraline|"50-200mg daily~Sertraline: 50-200mg daily"
11153627|NCT01896934|EG000|Reported Event|Sertraline|50-200mg daily
11153628|NCT01896986|BG000|Baseline|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy"
11153629|NCT01896986|BG001|Baseline|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy"
11153630|NCT01896986|BG002|Baseline|Total|Total of all reporting groups
11153631|NCT01896986|FG000|Participant Flow|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy"
11153632|NCT01896986|FG001|Participant Flow|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy"
11153633|NCT01896986|OG000|Outcome|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy~No samples analysed."
11153634|NCT01896986|OG001|Outcome|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy~No samples analysed."
11153635|NCT01896986|EG000|Reported Event|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy~no adverse events"
11153636|NCT01896986|EG001|Reported Event|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy~no adverse events"
11153637|NCT01897025|BG000|Baseline|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
11153638|NCT01897025|BG001|Baseline|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
11153639|NCT01897025|BG002|Baseline|Total|Total of all reporting groups
11153640|NCT01897025|FG000|Participant Flow|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
11153641|NCT01897025|FG001|Participant Flow|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
11153642|NCT01897025|OG000|Outcome|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
11228137|NCT02388347|FG003|Participant Flow|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
11228138|NCT02388347|FG004|Participant Flow|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
11153643|NCT01897025|OG001|Outcome|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
11153644|NCT01897025|EG000|Reported Event|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
11153645|NCT01897025|EG001|Reported Event|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
11153646|NCT01897077|BG000|Baseline|Peanut Allergic|"Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film.~Peanut Dissolving Film"
11153647|NCT01897077|BG001|Baseline|Healthy Volunteers|"Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.~Peanut Dissolving Film"
11153648|NCT01897077|BG002|Baseline|Total|Total of all reporting groups
11153649|NCT01897077|FG000|Participant Flow|Peanut Allergic|"Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film.~Peanut Dissolving Film.~No subjects were enrolled before termination."
11153650|NCT01897077|FG001|Participant Flow|Healthy Volunteers|"Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.~Peanut Dissolving Film~5 subjects received the active film."
11153651|NCT01897077|OG000|Outcome|Peanut Allergic|"Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film.~Peanut Dissolving Film.~No subjects were enrolled before termination."
11153652|NCT01897077|OG001|Outcome|Healthy Volunteers|"Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.~Peanut Dissolving Film~5 subjects received the active film."
11153653|NCT01897077|EG000|Reported Event|Peanut Allergic|"Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film.~Peanut Dissolving Film.~No subjects were enrolled before termination."
11153654|NCT01897077|EG001|Reported Event|Healthy Volunteers|"Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.~Peanut Dissolving Film~5 subjects received the active film."
11153655|NCT01897233|BG000|Baseline|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
11153656|NCT01897233|FG000|Participant Flow|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 milligram (mg) in fixed-dose combination with IVA 250 mg orally every 12 hours (q12h) for 14 days.~Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
11153657|NCT01897233|OG000|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
11153658|NCT01897233|OG000|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
11153659|NCT01897233|OG000|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks
11153660|NCT01897233|EG000|Reported Event|Part A Cohort 1: LUM/IVA|Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
11153661|NCT01897233|EG001|Reported Event|Part A Cohort 2: LUM/IVA|Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
11153662|NCT01897233|EG002|Reported Event|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
11153663|NCT01897285|BG000|Baseline|All Participants: AQUACEL® Foam Adhesive Dressings|"Original adhesive + test adhesive~AQUACEL® foam adhesive dressings"
11153664|NCT01897285|FG000|Participant Flow|All Study Participants|"Original adhesive and Test adhesive on right and left upper arm and right and left lower back.~AQUACEL® foam adhesive dressing Original Adhesive: Arm, Test Adhesive: Arm, Original Adhesive: Back, Test Adhesive: Back"
11153665|NCT01897285|OG000|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
11153666|NCT01897285|OG001|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
11153667|NCT01897285|EG000|Reported Event|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
11153668|NCT01897285|EG001|Reported Event|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
11153669|NCT01897402|BG000|Baseline|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
11153670|NCT01897402|BG001|Baseline|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
11153671|NCT01897402|BG002|Baseline|Total|Total of all reporting groups
11153672|NCT01897402|FG000|Participant Flow|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
11153673|NCT01897402|FG001|Participant Flow|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
11153674|NCT01897402|OG000|Outcome|Test Vaccine|"NmVac4-A/C/Y/W-135-DT™ conjugate vaccine~Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid."
11153675|NCT01897402|OG001|Outcome|US Licensed Vaccine|"Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine~US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid."
11153676|NCT01897402|OG000|Outcome|Test Vaccine - Male|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
11153677|NCT01897402|OG001|Outcome|Test Vaccine - Female|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
11153678|NCT01897402|OG002|Outcome|US Licensed Vaccine - Male|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
11153679|NCT01897402|OG003|Outcome|US Licensed Vaccine - Female|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
11153680|NCT01897402|OG000|Outcome|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
11153681|NCT01897402|OG001|Outcome|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
11153682|NCT01897402|EG000|Reported Event|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
11153683|NCT01897402|EG001|Reported Event|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
11153684|NCT01897493|BG000|Baseline|Evacetrapib+Digoxin|Period 1 (Day 1 through Day 6 Predose): Participants received a single oral dose of 0.5 mg digoxin on Day 1 Period 2 (Day 6 Post-Dose through Day 20): Participants received an oral dose of 130 mg evacetrapib QD on Days 6 through 19 with a single oral dose of 0.5 mg digoxin administered on Day 15
11153685|NCT01897493|FG000|Participant Flow|Evacetrapib+Digoxin|Period 1 (Day 1 through Day 6 predose): Participants received a single oral dose of 0.5 milligrams (mg) digoxin on Day 1 Period 2 (Day 6 postdose through Day 20): Participants received an oral dose of 130 mg evacetrapib once daily (QD) on Days 6 through 19 with single oral dose of 0.5 mg digoxin administered on Day 15
11153686|NCT01897493|OG000|Outcome|Period 1-Digoxin|Digoxin: Participants received 0.5 mg digoxin administered orally QD on Day 1
11153687|NCT01897493|OG001|Outcome|Period 2-Evacetrapib + Digoxin|Evacetrapib+Digoxin: Participants received 130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
11153688|NCT01897493|EG000|Reported Event|Digoxin|Digoxin: Participants received a single dose of 0.5 mg digoxin administered orally on Day 1. Adverse events (AEs) are reported through predose on Day 6
11153689|NCT01897493|EG001|Reported Event|Evacetrapib|Evacetrapib: Participants received 130 mg evacetrapib administered orally, alone, QD for Days 6 up to 15. AEs are reported from post-dose on Day 6 through predose of Digoxin on Day 15.
11153690|NCT01897493|EG002|Reported Event|Evacetrapib + Digoxin|Evacetrapib+Digoxin: Participants received 130 mg evacetrapib administered orally, QD for 14 days (Days 6 to 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15. AEs are reported from post-dose on Day 15 up to Day 33.
11153691|NCT01897532|BG000|Baseline|Placebo|"Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.~At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).~At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve)."
11153692|NCT01897532|BG001|Baseline|Linagliptin|"Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.~At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).~At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve)."
11153693|NCT01897532|BG002|Baseline|Total|Total of all reporting groups
11153694|NCT01897532|FG000|Participant Flow|Placebo|"Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.~At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).~At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve)."
11153695|NCT01897532|FG001|Participant Flow|Linagliptin|"Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.~At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).~At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve)."
11153696|NCT01897532|OG000|Outcome|Placebo|"Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.~At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).~At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve)."
11153697|NCT01897532|OG001|Outcome|Linagliptin|"Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.~At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).~At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve)."
11153698|NCT01897532|EG000|Reported Event|Placebo|"Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.~At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).~At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve)."
11228139|NCT02388347|OG000|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
11153699|NCT01897532|EG001|Reported Event|Linagliptin|"Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.~At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).~At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve)."
11153700|NCT01897714|BG000|Baseline|Phase I: Melflufen 15 mg + Dexamethasone|Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153701|NCT01897714|BG001|Baseline|Phase I: Melflufen 25 mg + Dexamethasone|Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153702|NCT01897714|BG002|Baseline|Phase I: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153703|NCT01897714|BG003|Baseline|Phase I: Melflufen 55 mg + Dexamethasone|Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153704|NCT01897714|BG004|Baseline|Phase I + II: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
11153705|NCT01897714|BG005|Baseline|Phase II: Melflufen 40 mg (Single Agent)|Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153706|NCT01897714|BG006|Baseline|Total|Total of all reporting groups
11153707|NCT01897714|FG000|Participant Flow|Phase I: Melflufen 15 mg + Dexamethasone|Patients were treated with 15 milligram (mg) melflufen as intravenous (IV) infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153708|NCT01897714|FG001|Participant Flow|Phase I: Melflufen 25 mg + Dexamethasone|Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153709|NCT01897714|FG002|Participant Flow|Phase I: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153710|NCT01897714|FG003|Participant Flow|Phase I: Melflufen 55 mg + Dexamethasone|Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153711|NCT01897714|FG004|Participant Flow|Phase I + II: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
11153712|NCT01897714|FG005|Participant Flow|Phase II: Melflufen 40 mg (Single Agent)|Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11228140|NCT02388347|OG001|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
11228141|NCT02388347|OG002|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
11153713|NCT01897714|OG000|Outcome|Phase I: Melflufen 15 mg + Dexamethasone|Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153714|NCT01897714|OG001|Outcome|Phase I: Melflufen 25 mg + Dexamethasone|Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153715|NCT01897714|OG002|Outcome|Phase I: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153716|NCT01897714|OG003|Outcome|Phase I: Melflufen 55 mg + Dexamethasone|Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153717|NCT01897714|OG004|Outcome|Phase I + II: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
11153718|NCT01897714|OG005|Outcome|Phase II: Melflufen 40 mg (Single Agent)|Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153719|NCT01897714|OG000|Outcome|Phase I + II: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
11153720|NCT01897714|OG001|Outcome|Phase II: Melflufen 40 mg (Single Agent)|Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153721|NCT01897714|EG000|Reported Event|Phase I: Melflufen 15 mg + Dexamethasone|Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153722|NCT01897714|EG001|Reported Event|Phase I: Melflufen 25 mg + Dexamethasone|Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153723|NCT01897714|EG002|Reported Event|Phase I: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153724|NCT01897714|EG003|Reported Event|Phase I: Melflufen 55 mg + Dexamethasone|Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11228142|NCT02388347|OG003|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
11228143|NCT02388347|OG004|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
11153725|NCT01897714|EG004|Reported Event|Phase I + II: Melflufen 40 mg + Dexamethasone|Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
11153726|NCT01897714|EG005|Reported Event|Phase II: Melflufen 40 mg (Single Agent)|Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
11153727|NCT01897727|BG000|Baseline|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
11153728|NCT01897727|BG001|Baseline|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
11153729|NCT01897727|BG002|Baseline|Total|Total of all reporting groups
11153730|NCT01897727|FG000|Participant Flow|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
11153731|NCT01897727|FG001|Participant Flow|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
11153732|NCT01897727|OG000|Outcome|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
11153733|NCT01897727|OG001|Outcome|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
11153734|NCT01897727|EG000|Reported Event|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
11153735|NCT01897727|EG001|Reported Event|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
11153736|NCT01897766|BG000|Baseline|Genotropin [Somatropin (Genetical Recombination)]|Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
11153737|NCT01897766|FG000|Participant Flow|Genotropin [Somatropin (Genetical Recombination)]|Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
11153738|NCT01897766|OG000|Outcome|Genotropin [Somatropin (Genetical Recombination)]|Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
11153739|NCT01897766|EG000|Reported Event|Genotropin [Somatropin (Genetical Recombination)]|Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
11153740|NCT01897792|BG000|Baseline|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
11153741|NCT01897792|BG001|Baseline|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
11153742|NCT01897792|BG002|Baseline|Total|Total of all reporting groups
11153743|NCT01897792|FG000|Participant Flow|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
11153744|NCT01897792|FG001|Participant Flow|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
11153745|NCT01897792|OG000|Outcome|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
11153746|NCT01897792|OG001|Outcome|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
11153747|NCT01897792|OG000|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
11153748|NCT01897792|OG001|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
11153749|NCT01897792|OG000|Outcome|Vitamin C and E Participants -|# of protocol deviations
11153750|NCT01897792|OG001|Outcome|0.9% Saline and Sugar Pill Participants - Protocol Violations|# of protocol deviations
11153751|NCT01897792|EG000|Reported Event|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
11153752|NCT01897792|EG001|Reported Event|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
11153753|NCT01897896|BG000|Baseline|Rollover Cohort: SD-809 ER|Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153754|NCT01897896|BG001|Baseline|Switch Cohort: SD-809 ER|Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant's prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153755|NCT01897896|BG002|Baseline|Total|Total of all reporting groups
11153756|NCT01897896|FG000|Participant Flow|Rollover Cohort: SD-809 ER|Participants who completed study SD-809-C-15 (either placebo or SD-809 group [NCT01795859], including 1-week washout period and Week 13 evaluation), received 6 milligrams(mg) SD-809 ER tablet once daily as starting dose in this study. Dose titration was continued through Week 8 to optimize dose. SD-809 ER dose could be adjusted weekly in increments of 6 milligrams per day(mg/day) (6 or 12 mg/day after total daily dose of 48 mg reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day(36 mg twice daily), unless participant was receiving a strong CYP2D6 inhibitor(e.g., paroxetine,buproprion, fluoxetine), in which case maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153757|NCT01897896|FG001|Participant Flow|Switch Cohort: SD-809 ER|Participants who were receiving Food and Drug Administration (FDA) - approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state area under the curve(AUC) of total (alpha+beta)-Dihydrotetrabenazine(HTBZ) metabolites that was predicted to be comparable to that of participant's prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. SD-809 ER dose could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after total daily dose of 48 mg reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153758|NCT01897896|OG000|Outcome|Rollover Cohort: SD-809 ER|Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153759|NCT01897896|OG001|Outcome|Switch Cohort: SD-809 ER|Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant's prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153760|NCT01897896|OG000|Outcome|Switch Cohort: SD-809 ER|Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant's prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153761|NCT01897896|OG000|Outcome|Combined Cohort (Rollover and Switch): SD-809 ER|Participants of rollover cohort and switch cohort were included in this arm for the purpose of reporting data of this outcome measure.
11153762|NCT01897896|EG000|Reported Event|Rollover Cohort: SD-809 ER|Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153763|NCT01897896|EG001|Reported Event|Switch Cohort: SD-809 ER|Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant's prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
11153764|NCT01898013|BG000|Baseline|Pregnenolone|"Pregnenolone fixed escalating up to 500mg/day will consist of the following schedule:~Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): 50mg PO, BID x 1 week, Visit 4 (week 2): 150mg PO, BID x 1 week, Visit 5 (week 3): 250mg PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered by 100mg per day and then discontinued.~Pregnenolone"
11153765|NCT01898013|BG001|Baseline|Placebo|"Placebo will be administered exactly the same as the active comparator (pregnenolone) and will consist of the following schedule:~Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): placebo PO, BID x 1 week, Visit 4 (week 2): placebo PO, BID x 1 week, Visit 5 (week 3): placebo PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered in the exact manner as active study medication and then discontinued.~Placebo"
11153766|NCT01898013|BG002|Baseline|Total|Total of all reporting groups
11153767|NCT01898013|FG000|Participant Flow|Pregnenolone|"Pregnenolone fixed escalating up to 500mg/day will consist of the following schedule:~Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): 50mg PO, BID x 1 week, Visit 4 (week 2): 150mg PO, BID x 1 week, Visit 5 (week 3): 250mg PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered by 100mg per day and then discontinued.~Pregnenolone"
11153768|NCT01898013|FG001|Participant Flow|Placebo|"Placebo will be administered exactly the same as the active comparator (pregnenolone) and will consist of the following schedule:~Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): placebo PO, BID x 1 week, Visit 4 (week 2): placebo PO, BID x 1 week, Visit 5 (week 3): placebo PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered in the exact manner as active study medication and then discontinued.~Placebo"
11153769|NCT01898013|OG000|Outcome|Pregnenolone|"Pregnenolone fixed escalating up to 500mg/day will consist of the following schedule:~Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): 50mg PO, BID x 1 week, Visit 4 (week 2): 150mg PO, BID x 1 week, Visit 5 (week 3): 250mg PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered by 100mg per day and then discontinued.~Pregnenolone"
11153770|NCT01898013|OG001|Outcome|Placebo|"Placebo will be administered exactly the same as the active comparator (pregnenolone) and will consist of the following schedule:~Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): placebo PO, BID x 1 week, Visit 4 (week 2): placebo PO, BID x 1 week, Visit 5 (week 3): placebo PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered in the exact manner as active study medication and then discontinued.~Placebo"
11153771|NCT01898013|EG000|Reported Event|Pregnenolone|"Pregnenolone fixed escalating up to 500mg/day with following schedule:~Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): 50mg PO, BID x 1 week, Visit 4 (week 2): 150mg PO, BID x 1 week, Visit 5 (week 3): 250mg PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered by 100mg per day and then discontinued.~Pregnenolone"
11228144|NCT02388347|OG000|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
11153772|NCT01898013|EG001|Reported Event|Placebo|"Placebo was administered exactly the same as the active comparator (pregnenolone) with the following schedule:~Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): placebo PO, BID x 1 week, Visit 4 (week 2): placebo PO, BID x 1 week, Visit 5 (week 3): placebo PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered in the exact manner as active study medication and then discontinued.~Placebo"
11153773|NCT01898078|BG000|Baseline|Alisertib 50 mg Fed + Fasted|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
11153774|NCT01898078|BG001|Baseline|Alisertib 50 mg Fasted + Fed|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
11153775|NCT01898078|BG002|Baseline|Total|Total of all reporting groups
11153776|NCT01898078|FG000|Participant Flow|Alisertib 50 mg Fed + Fasted|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
11153777|NCT01898078|FG001|Participant Flow|Alisertib 50 mg Fasted + Fed|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
11153778|NCT01898078|OG000|Outcome|Alisertib 50 mg Fed|Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
11153779|NCT01898078|OG001|Outcome|Alisertib 50 mg Fasted|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
11153780|NCT01898078|OG000|Outcome|Alisertib 50 mg Fed + Fasted|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
11153781|NCT01898078|OG001|Outcome|Alisertib 50 mg Fasted + Fed|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
11153782|NCT01898078|EG000|Reported Event|Alisertib 50 mg Fed + Fasted|Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
10851399|NCT00306202|OG001|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
11153783|NCT01898078|EG001|Reported Event|Alisertib 50 mg Fasted + Fed|Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
11153784|NCT01898091|BG000|Baseline|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
11153785|NCT01898091|BG001|Baseline|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
11153786|NCT01898091|BG002|Baseline|Total|Total of all reporting groups
11153787|NCT01898091|FG000|Participant Flow|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base plus 1% solution by weight of neem supercritical extract], three times per day, for approximately 7 weeks during radiation therapy."
11153788|NCT01898091|FG001|Participant Flow|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base], three times per day, for approximately 7 weeks during radiation therapy."
11153789|NCT01898091|OG000|Outcome|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
11153790|NCT01898091|OG001|Outcome|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
11153791|NCT01898091|EG000|Reported Event|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base plus 1% solution by weight of neem supercritical extract], three times per day, for approximately 7 weeks during radiation therapy."
11153792|NCT01898091|EG001|Reported Event|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base], three times per day, for approximately 7 weeks during radiation therapy."
11153793|NCT01898130|BG000|Baseline|Treatment (Bevacizumab)|"Patients receive 10mg/kg bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Quality-of-life assessment: Ancillary studies"
11153794|NCT01898130|FG000|Participant Flow|Treatment (Bevacizumab)|"Patients receive 10mg/kg bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Quality-of-life assessment: Ancillary studies"
11153795|NCT01898130|OG000|Outcome|Treatment (Bevacizumab)|"Patients receive 10mg/kg bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Quality-of-life assessment: Ancillary studies"
11153796|NCT01898130|EG000|Reported Event|Treatment (Bevacizumab)|"Patients receive 10mg/kg bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Quality-of-life assessment: Ancillary studies"
11153797|NCT01898195|BG000|Baseline|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
11153798|NCT01898195|BG001|Baseline|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
11153799|NCT01898195|BG002|Baseline|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
11153800|NCT01898195|BG003|Baseline|Total|Total of all reporting groups
11153801|NCT01898195|FG000|Participant Flow|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
11153802|NCT01898195|FG001|Participant Flow|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
11153803|NCT01898195|FG002|Participant Flow|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
11153804|NCT01898195|OG000|Outcome|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
11153805|NCT01898195|OG001|Outcome|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
11153806|NCT01898195|OG002|Outcome|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
11153807|NCT01898195|EG000|Reported Event|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
11153808|NCT01898195|EG001|Reported Event|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
11228145|NCT02388347|OG001|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
11153809|NCT01898195|EG002|Reported Event|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
11153810|NCT01898208|BG000|Baseline|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
11153811|NCT01898208|BG001|Baseline|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
11153812|NCT01898208|BG002|Baseline|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
11153813|NCT01898208|BG003|Baseline|Total|Total of all reporting groups
11153814|NCT01898208|FG000|Participant Flow|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
11153815|NCT01898208|FG001|Participant Flow|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture Infectious Disease (ID) Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
11153816|NCT01898208|FG002|Participant Flow|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
11153817|NCT01898208|OG000|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
11153818|NCT01898208|OG001|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
11153819|NCT01898208|OG002|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
11153820|NCT01898208|EG000|Reported Event|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
11153821|NCT01898208|EG001|Reported Event|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
11153822|NCT01898208|EG002|Reported Event|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
11153823|NCT01898286|BG000|Baseline|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
11153824|NCT01898286|FG000|Participant Flow|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
11153825|NCT01898286|OG000|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
11153826|NCT01898286|EG000|Reported Event|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
11153827|NCT01898299|BG000|Baseline|Transcranial Direct Current Stimulation|"Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days~transcranial Direct Current Stimulation (tDCS): A neurostimulation technique that passes an extremely weak electric current through the brain."
11153828|NCT01898299|BG001|Baseline|Sham tDCS|"Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.~Sham tDCS: Sham (inactive) tDCS treatment"
11153829|NCT01898299|BG002|Baseline|Total|Total of all reporting groups
11153830|NCT01898299|FG000|Participant Flow|Transcranial Direct Current Stimulation|"Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days~transcranial Direct Current Stimulation (tDCS): A neurostimulation technique that passes an extremely weak electric current through the brain."
11153831|NCT01898299|FG001|Participant Flow|Sham tDCS|"Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.~Sham tDCS: Sham (inactive) tDCS treatment"
11153832|NCT01898299|OG000|Outcome|Transcranial Direct Current Stimulation|"Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days~transcranial Direct Current Stimulation (tDCS): A neurostimulation technique that passes an extremely weak electric current through the brain."
11153833|NCT01898299|OG001|Outcome|Sham tDCS|"Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.~Sham tDCS: Sham (inactive) tDCS treatment"
11153834|NCT01898299|EG000|Reported Event|Transcranial Direct Current Stimulation|"Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days~transcranial Direct Current Stimulation (tDCS): A neurostimulation technique that passes an extremely weak electric current through the brain."
11228146|NCT02388347|OG002|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
11153835|NCT01898299|EG001|Reported Event|Sham tDCS|"Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.~Sham tDCS: Sham (inactive) tDCS treatment"
11153836|NCT01898403|BG000|Baseline|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
11153837|NCT01898403|FG000|Participant Flow|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
11153838|NCT01898403|OG000|Outcome|Sentinel Lymph Node (SLN) Detection by Isosulfan Blue|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
11153839|NCT01898403|OG001|Outcome|Sentinel Lymph Node (SLN) Detection by Indocyanine Green|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
11153840|NCT01898403|OG002|Outcome|Sentinel Lymph Node (SLN) Detection by TSC Lymphoscintigraphy|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
11153841|NCT01898403|EG000|Reported Event|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
11153842|NCT01898429|BG000|Baseline|All Participants|"Active Stimulation of the left-sided electrode in the first phase (followed by right-sided stimulation in the second phase)~SCC DBS: Deep Brain Stimulator"
11153843|NCT01898429|FG000|Participant Flow|Left-sided SCC DBS|"Active Stimulation of the left-sided electrode~SCC DBS: Deep Brain Stimulator"
11153844|NCT01898429|FG001|Participant Flow|Right-sided SCC DBS|"Active stimulation of the right-sided electrode~SCC DBS: Deep Brain Stimulator"
11153845|NCT01898429|FG002|Participant Flow|Bilateral SCC DBS|12 weeks of bilateral SCC DBS
11153846|NCT01898429|OG000|Outcome|All Participants|"Active Stimulation of the left-sided electrode in the first phase (followed by right-sided stimulation in the second phase)~SCC DBS: Deep Brain Stimulator"
11153847|NCT01898429|EG000|Reported Event|All Participants|"Active Stimulation of the left-sided electrode in the first phase (followed by right-sided stimulation in the second phase)~SCC DBS: Deep Brain Stimulator"
11153848|NCT01898442|BG000|Baseline|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
11153849|NCT01898442|BG001|Baseline|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
11153850|NCT01898442|BG002|Baseline|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
11153851|NCT01898442|BG003|Baseline|Total|Total of all reporting groups
11153852|NCT01898442|FG000|Participant Flow|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
11153853|NCT01898442|FG001|Participant Flow|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
11153854|NCT01898442|FG002|Participant Flow|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
11153855|NCT01898442|OG000|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
11153856|NCT01898442|OG001|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
11153857|NCT01898442|OG002|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
11153858|NCT01898442|EG000|Reported Event|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
11153859|NCT01898442|EG001|Reported Event|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
11153860|NCT01898442|EG002|Reported Event|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
11153861|NCT01898598|BG000|Baseline|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
11153862|NCT01898598|BG001|Baseline|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
11153863|NCT01898598|BG002|Baseline|Total|Total of all reporting groups
11153864|NCT01898598|FG000|Participant Flow|Vismodegib|Participants received vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
11153865|NCT01898598|FG001|Participant Flow|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
11153866|NCT01898598|OG000|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
11153867|NCT01898598|OG001|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
11153868|NCT01898598|EG000|Reported Event|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
11153869|NCT01898598|EG001|Reported Event|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
11153870|NCT01898611|BG000|Baseline|Ghrelin Plus Resistance Training|"Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training~Ghrelin: 2:1 ratio placebo to ghrelin~Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights."
11153871|NCT01898611|BG001|Baseline|Placebo Plus Resistance Training|"Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training~Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights."
11153872|NCT01898611|BG002|Baseline|Total|Total of all reporting groups
11153873|NCT01898611|FG000|Participant Flow|Ghrelin Plus Resistance Training|"Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training~Ghrelin: 2:1 ratio placebo to ghrelin~Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights."
11153874|NCT01898611|FG001|Participant Flow|Placebo Plus Resistance Training|"Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training~Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights."
11153875|NCT01898611|OG000|Outcome|Ghrelin Plus Resistance Training|"Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training~Ghrelin: 2:1 ratio placebo to ghrelin~Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights."
11153876|NCT01898611|OG001|Outcome|Placebo Plus Resistance Training|"Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training~Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights."
11153877|NCT01898611|EG000|Reported Event|Ghrelin Plus Resistance Training|"Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training~Ghrelin: 2:1 ratio placebo to ghrelin~Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights."
11153878|NCT01898611|EG001|Reported Event|Placebo Plus Resistance Training|"Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training~Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights."
11173828|NCT02018042|OG000|Outcome|Abatacept|"Patients will be treated with abatacept 125mg subcutaneous (SC) self-administered each week. Treatment will be continued for 6 months to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with alopecia areata. Patients will then be followed for an additional 6 months to assess the timing and incidence of relapse.~Abatacept: After the screening period, subjects will begin weekly self-administered subcutaneous abatacept and will continue treatment for 6 months. Patients will be instructed in self-administration of study medication at baseline (week zero) and will be observed self-administering medication at each visit. Instructions regarding study drug administration will be reinforced as needed.~The 6-month treatment period is expected to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with moderate to severe AAP. Responders will then be followed for 6 months off drug."
11173829|NCT02018042|EG000|Reported Event|Abatacept|"Patients will be treated with abatacept 125mg subcutaneous (SC) self-administered each week. Treatment will be continued for 6 months to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with alopecia areata. Patients will then be followed for an additional 6 months to assess the timing and incidence of relapse.~Abatacept: After the screening period, subjects will begin weekly self-administered subcutaneous abatacept and will continue treatment for 6 months. Patients will be instructed in self-administration of study medication at baseline (week zero) and will be observed self-administering medication at each visit. Instructions regarding study drug administration will be reinforced as needed.~The 6-month treatment period is expected to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with moderate to severe AAP. Responders will then be followed for 6 months off drug."
11173830|NCT02018107|BG000|Baseline|N-13 Ammoniaor F-18 Fluorodeoxygl to Image Liver PET Perfusion|"This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only~N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer~PET scan: PET scan"
11173831|NCT02018107|FG000|Participant Flow|N-13 Ammonia to Image Liver PET Perfusion|"This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only~N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer~PET scan: PET scan"
11228147|NCT02388347|OG003|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
11153879|NCT01898689|BG000|Baseline|Right Side: Ropivacaine 0.1%|Bilateral sciatic perineural catheters were inserted and ropivacaine infused as a basal infusion through both for 6 hours. The right side of the body received 0.1% at 8 mL/h and the left side of the body received 0.4% at 2 mL/h.
11153880|NCT01898689|BG001|Baseline|Right Side: Ropivacaine 0.4%|Bilateral sciatic perineural catheters were inserted and ropivacaine infused as a basal infusion through both for 6 hours. The right side of the body received 0.4% at 2 mL/h and the left side of the body received 0.1% at 8 mL/h.
11153881|NCT01898689|BG002|Baseline|Total|Total of all reporting groups
11153882|NCT01898689|FG000|Participant Flow|Right Side Ropivacaine 0.1%, Left Side Ropivacaine 0.4%|Ropivacaine 0.1% administered at 8 mL/h basal for 6 hours on the right side of the body while ropivacaine 0.4% administered at 2 mL/h basal for 6 hours on the left side of the body.
11153883|NCT01898689|FG001|Participant Flow|Right Side Ropivacaine 0.4%, Left Side Ropivacaine 0.1%|Ropivacaine 0.4% administered at 2 mL/h basal for 6 hours on the right side of the body while ropivacaine 0.1% administered at 8 mL/h basal for 6 hours on the left side of the body.
11153884|NCT01898689|OG000|Outcome|Ropivacaine 0.1%|Bilateral sciatic perineural catheters are inserted and ropivacaine is infused as a basal infusion for 6 hours. The right side received 0.1% at 8 mL/h and the left side received 0.4% at 2 mL/h.
11153885|NCT01898689|OG001|Outcome|Ropivacaine 0.4%|Bilateral sciatic perineural catheters are inserted and ropivacaine is infused as a basal infusion for 6 hours. The right side received 0.4% at 2 mL/h and the left side received 0.1% at 8 mL/h.
11153886|NCT01898689|OG000|Outcome|Ropivacaine 0.1%|Ropivacaine 0.1% administered at 8 mL/h basal for 6 hours on the right side of the body while ropivacaine 0.4% administered at 2 mL/h basal for 6 hours on the left side of the body.
11153887|NCT01898689|OG001|Outcome|Ropivacaine 0.4%|Ropivacaine 0.4% administered at 2 mL/h basal for 6 hours on the right side of the body while ropivacaine 0.1% administered at 8 mL/h basal for 6 hours on the left side of the body.
11153888|NCT01898689|EG000|Reported Event|Ropivacaine 0.1%|"Ropivacaine 0.1% at 8 mL/h basal for 6 hours~perineural infusion: A continuous peripheral nerve block-also termed perineural local anesthetic infusion-involves the insertion of a tiny tube (a catheter) through the skin and adjacent to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be provided in the hospital setting, but the use of lightweight, portable pumps permits infusion at home as well."
11153889|NCT01898689|EG001|Reported Event|Ropivacaine 0.4%|"Ropivacaine 0.4% at 2 mL/h basal for 6 hours~perineural infusion: A continuous peripheral nerve block-also termed perineural local anesthetic infusion-involves the insertion of a tiny tube (a catheter) through the skin and adjacent to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be provided in the hospital setting, but the use of lightweight, portable pumps permits infusion at home as well."
11153890|NCT01898754|BG000|Baseline|Pre-ART Oligonucleotide Assay (OLA)|"Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)~Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART"
11153891|NCT01898754|BG001|Baseline|No OLA (Standard of Care [SOC])|The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
11153892|NCT01898754|BG002|Baseline|Total|Total of all reporting groups
11153893|NCT01898754|FG000|Participant Flow|Pre-ART Oligonucleotide Assay (OLA)|"Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)~Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART"
11153894|NCT01898754|FG001|Participant Flow|No OLA (Standard of Care [SOC])|The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
11153895|NCT01898754|OG000|Outcome|Pre-ART Oligonucleotide Assay (OLA)|"Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)~Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART"
11153896|NCT01898754|OG001|Outcome|No OLA (Standard of Care [SOC])|The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
11153897|NCT01898754|EG000|Reported Event|Pre-ART Oligonucleotide Assay (OLA)|"Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)~Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART"
11153898|NCT01898754|EG001|Reported Event|No OLA (Standard of Care [SOC])|The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
11153899|NCT01898806|BG000|Baseline|All Participants|Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo. Since the PI left the institution, the only data available at this time is information on the population enrolled that was provided to the IRB. Data was not provided to the IRB per arm, but rather, for as a collective whole.
11153900|NCT01898806|FG000|Participant Flow|All Participants|Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
11153901|NCT01898806|OG000|Outcome|All Participants|Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
11153902|NCT01898806|EG000|Reported Event|All Participants|Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo. Data was not collected per arm, but rather, for as a collective whole.
11153903|NCT01898884|BG000|Baseline|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
11153904|NCT01898884|BG001|Baseline|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
11153905|NCT01898884|BG002|Baseline|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
11153906|NCT01898884|BG003|Baseline|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
11153907|NCT01898884|BG004|Baseline|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
11153908|NCT01898884|BG005|Baseline|Total|Total of all reporting groups
11153909|NCT01898884|FG000|Participant Flow|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
11153910|NCT01898884|FG001|Participant Flow|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
11153911|NCT01898884|FG002|Participant Flow|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
11153912|NCT01898884|FG003|Participant Flow|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
11153913|NCT01898884|FG004|Participant Flow|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
11153914|NCT01898884|FG005|Participant Flow|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
11153915|NCT01898884|FG006|Participant Flow|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153916|NCT01898884|FG007|Participant Flow|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153917|NCT01898884|FG008|Participant Flow|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153918|NCT01898884|OG000|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
11153919|NCT01898884|OG001|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
11153920|NCT01898884|OG002|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
11153921|NCT01898884|OG003|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
11153922|NCT01898884|OG004|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
11153923|NCT01898884|OG005|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
11153924|NCT01898884|OG006|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153925|NCT01898884|OG007|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153926|NCT01898884|OG008|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153927|NCT01898884|OG002|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
11153928|NCT01898884|OG003|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
11153929|NCT01898884|OG004|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
11153930|NCT01898884|OG001|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
11153931|NCT01898884|OG000|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
11153932|NCT01898884|OG001|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
11153933|NCT01898884|OG002|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
11153934|NCT01898884|OG003|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
11153935|NCT01898884|OG001|Outcome|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
11153936|NCT01898884|OG000|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
11153937|NCT01898884|OG001|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153938|NCT01898884|OG002|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153939|NCT01898884|OG003|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153940|NCT01898884|OG000|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153941|NCT01898884|OG001|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153942|NCT01898884|OG002|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153943|NCT01898884|EG000|Reported Event|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting conditions on Day 1.
11153944|NCT01898884|EG001|Reported Event|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting conditions on Day 1.
11153945|NCT01898884|EG002|Reported Event|Single Dose VP 20629 450mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting conditions on Day 1.
11153946|NCT01898884|EG003|Reported Event|Single Dose VP 20629 900mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting conditions on Day 1.
11153947|NCT01898884|EG004|Reported Event|Single Dose VP 20629 1200mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting conditions on Day 1.
11153948|NCT01898884|EG005|Reported Event|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
11153949|NCT01898884|EG006|Reported Event|Multiple Dose VP 20629 300mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153950|NCT01898884|EG007|Reported Event|Multiple Dose VP 20629 600mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153951|NCT01898884|EG008|Reported Event|Multiple Dose VP 20629 900mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
11153952|NCT01898923|BG000|Baseline|ON101 Cream|"ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.~ON101 Cream"
11153953|NCT01898923|BG001|Baseline|Aquacel® Hydrofiber® Dressing|"Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.~Aquacel® Hydrofiber® dressing"
11153954|NCT01898923|BG002|Baseline|Total|Total of all reporting groups
11153955|NCT01898923|FG000|Participant Flow|ON101 Cream|"ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.~ON101 Cream"
11153956|NCT01898923|FG001|Participant Flow|Aquacel® Hydrofiber® Dressing|"Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.~Aquacel® Hydrofiber® dressing"
11153957|NCT01898923|OG000|Outcome|ON101 Cream|"ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.~ON101 Cream"
11153958|NCT01898923|OG001|Outcome|Aquacel® Hydrofiber® Dressing|"Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.~Aquacel® Hydrofiber® dressing"
11153959|NCT01898923|EG000|Reported Event|ON101 Cream|"ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.~ON101 Cream"
11153960|NCT01898923|EG001|Reported Event|Aquacel® Hydrofiber® Dressing|"Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.~Aquacel® Hydrofiber® dressing"
11153961|NCT01899053|BG000|Baseline|Dose Escalation Treatment Arm A: Cohort 1A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.
11153962|NCT01899053|BG001|Baseline|Dose Escalation Treatment Arm A: Cohort 2A|TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.
11153963|NCT01899053|BG002|Baseline|Dose Escalation Treatment Arm A: Cohort 3A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.
11153964|NCT01899053|BG003|Baseline|Dose Escalation Treatment Arm A: Cohort 3A (Milled)|TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.
11153965|NCT01899053|BG004|Baseline|Dose Escalation Treatment Arm A: Cohort 4A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.
11153966|NCT01899053|BG005|Baseline|Dose Escalation Treatment Arm B: Cohort 1B|TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.
11153967|NCT01899053|BG006|Baseline|Dose Escalation Treatment Arm B: Cohort 2B|TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.
11153968|NCT01899053|BG007|Baseline|Dose Escalation Treatment Arm B: Cohort 3B|TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.
11153969|NCT01899053|BG008|Baseline|Dose Escalation Treatment Arm B: Cohort 3B (Milled)|TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.
11153970|NCT01899053|BG009|Baseline|Dose Escalation Treatment Arm B: Cohort 4B|TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.
11153971|NCT01899053|BG010|Baseline|Dose Escalation Treatment Arm B: Cohort 5B (Milled)|TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.
11153972|NCT01899053|BG011|Baseline|Dose Escalation Treatment Arm C: Cohort 1C|TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.
11228148|NCT02388347|EG000|Reported Event|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
11153973|NCT01899053|BG012|Baseline|Dose Escalation Treatment Arm C: Cohort 2C (Milled)|TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.
11153974|NCT01899053|BG013|Baseline|Drug-Drug Interaction (DDI) Expansion Cohort (Milled)|TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
11153975|NCT01899053|BG014|Baseline|Total|Total of all reporting groups
11153976|NCT01899053|FG000|Participant Flow|Dose Escalation Treatment Arm A: Cohort 1A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.
11153977|NCT01899053|FG001|Participant Flow|Dose Escalation Treatment Arm A: Cohort 2A|TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.
11153978|NCT01899053|FG002|Participant Flow|Dose Escalation Treatment Arm A: Cohort 3A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.
11153979|NCT01899053|FG003|Participant Flow|Dose Escalation Treatment Arm A: Cohort 3A (Milled)|TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.
11153980|NCT01899053|FG004|Participant Flow|Dose Escalation Treatment Arm A: Cohort 4A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.
11153981|NCT01899053|FG005|Participant Flow|Dose Escalation Treatment Arm B: Cohort 1B|TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.
11153982|NCT01899053|FG006|Participant Flow|Dose Escalation Treatment Arm B: Cohort 2B|TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.
11153983|NCT01899053|FG007|Participant Flow|Dose Escalation Treatment Arm B: Cohort 3B|TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.
11153984|NCT01899053|FG008|Participant Flow|Dose Escalation Treatment Arm B: Cohort 3B (Milled)|TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.
11153985|NCT01899053|FG009|Participant Flow|Dose Escalation Treatment Arm B: Cohort 4B|TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.
11153986|NCT01899053|FG010|Participant Flow|Dose Escalation Treatment Arm B: Cohort 5B (Milled)|TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.
11153987|NCT01899053|FG011|Participant Flow|Dose Escalation Treatment Arm C: Cohort 1C|TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.
11153988|NCT01899053|FG012|Participant Flow|Dose Escalation Treatment Arm C: Cohort 2C (Milled)|TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.
11153989|NCT01899053|FG013|Participant Flow|Drug-Drug Interaction (DDI) Expansion Cohort (Milled)|TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
11153990|NCT01899053|OG000|Outcome|Dose Escalation Treatment Arm A: Cohort 1A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.
11153991|NCT01899053|OG001|Outcome|Dose Escalation Treatment Arm A: Cohort 2A|TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.
11153992|NCT01899053|OG002|Outcome|Dose Escalation Treatment Arm A: Cohort 3A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.
11153993|NCT01899053|OG003|Outcome|Dose Escalation Treatment Arm A: Cohort 3A (Milled)|TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.
11153994|NCT01899053|OG004|Outcome|Dose Escalation Treatment Arm A: Cohort 4A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.
11153995|NCT01899053|OG005|Outcome|Dose Escalation Treatment Arm B: Cohort 1B|TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.
11153996|NCT01899053|OG006|Outcome|Dose Escalation Treatment Arm B: Cohort 2B|TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.
11228149|NCT02388347|EG001|Reported Event|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
11153997|NCT01899053|OG007|Outcome|Dose Escalation Treatment Arm B: Cohort 3B|TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.
11153998|NCT01899053|OG008|Outcome|Dose Escalation Treatment Arm B: Cohort 3B (Milled)|TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.
11153999|NCT01899053|OG009|Outcome|Dose Escalation Treatment Arm B: Cohort 4B|TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.
11154000|NCT01899053|OG010|Outcome|Dose Escalation Treatment Arm B: Cohort 5B (Milled)|TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.
11154001|NCT01899053|OG011|Outcome|Dose Escalation Treatment Arm C: Cohort 1C|TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.
11154002|NCT01899053|OG012|Outcome|Dose Escalation Treatment Arm C: Cohort 2C (Milled)|TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.
11154003|NCT01899053|OG013|Outcome|Drug-Drug Interaction (DDI) Expansion Cohort (Milled)|TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
11154004|NCT01899053|OG000|Outcome|Drug-Drug Interaction (DDI) Expansion Cohort (Milled)|TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
11154005|NCT01899053|OG000|Outcome|Drug-Drug Interaction (DDI) Expansion Cohort (Milled))|TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
11154006|NCT01899053|EG000|Reported Event|Dose Escalation Treatment Arm A: Cohort 1A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.
11154007|NCT01899053|EG001|Reported Event|Dose Escalation Treatment Arm A: Cohort 2A|TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.
11154008|NCT01899053|EG002|Reported Event|Dose Escalation Treatment Arm A: Cohort 3A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.
11154009|NCT01899053|EG003|Reported Event|Dose Escalation Treatment Arm A: Cohort 3A (Milled)|TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.
11154010|NCT01899053|EG004|Reported Event|Dose Escalation Treatment Arm A: Cohort 4A|TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.
11154011|NCT01899053|EG005|Reported Event|Dose Escalation Treatment Arm B: Cohort 1B|TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.
11154012|NCT01899053|EG006|Reported Event|Dose Escalation Treatment Arm B: Cohort 2B|TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.
11154013|NCT01899053|EG007|Reported Event|Dose Escalation Treatment Arm B: Cohort 3B|TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.
11154014|NCT01899053|EG008|Reported Event|Dose Escalation Treatment Arm B: Cohort 3B (Milled)|TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.
11154015|NCT01899053|EG009|Reported Event|Dose Escalation Treatment Arm B: Cohort 4B|TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.
11154016|NCT01899053|EG010|Reported Event|Dose Escalation Treatment Arm B: Cohort 5B (Milled)|TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.
11154017|NCT01899053|EG011|Reported Event|Dose Escalation Treatment Arm C: Cohort 1C|TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.
11154018|NCT01899053|EG012|Reported Event|Dose Escalation Treatment Arm C: Cohort 2C (Milled)|TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.
11154019|NCT01899053|EG013|Reported Event|Drug-Drug Interaction (DDI) Expansion Cohort (Milled)|TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
11154020|NCT01899300|BG000|Baseline|Metal Stent 8 Week Indwell|Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days
11154021|NCT01899300|FG000|Participant Flow|Metal Stent 8 Week Indwell|Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days
11154022|NCT01899300|FG001|Participant Flow|Metal Stent 12 Week Indwell|Patients 11 to 20 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 12 weeks +/- 7 days
11154023|NCT01899300|OG000|Outcome|Metal Stent 8 Week Indwell|"The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion.~Metal Stent (WallFlex™ Esophageal RX)"
11154024|NCT01899300|OG000|Outcome|Metal Stent 8 Week Indwell|"The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS)is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion.~Metal Stent (WallFlex™ Esophageal RX)"
11154025|NCT01899300|OG000|Outcome|Metal Stent 8 Week Indwell|Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days
11154026|NCT01899300|EG000|Reported Event|Metal Stent 8 Week Indwell|Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days
11154027|NCT01899677|BG000|Baseline|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
11154028|NCT01899677|BG001|Baseline|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
11154029|NCT01899677|BG002|Baseline|Total|Total of all reporting groups
11154030|NCT01899677|FG000|Participant Flow|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
11154031|NCT01899677|FG001|Participant Flow|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
11154032|NCT01899677|OG000|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
11154033|NCT01899677|OG001|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
11154034|NCT01899677|EG000|Reported Event|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
11154035|NCT01899677|EG001|Reported Event|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
11154036|NCT01899742|BG000|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11154037|NCT01899742|BG001|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11154038|NCT01899742|BG002|Baseline|Total|Total of all reporting groups
11154039|NCT01899742|FG000|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg) once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11154040|NCT01899742|FG001|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11154041|NCT01899742|OG000|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11154042|NCT01899742|OG001|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11154043|NCT01899742|EG000|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11154044|NCT01899742|EG001|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11174304|NCT02020785|FG000|Participant Flow|Higher Phosphorus Period First, Then Lower Phosphorus Period|"Randomized to higher phosphorus period first, then lower phosphorus period second.~Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks~At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives~Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) given for 3 weeks~Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks"
11154045|NCT01899768|BG000|Baseline|GSK2339345 1000 µg/Placebo|Participants received two doses of either GSK2339345 1000 µg or matching placebo as a solution administered via an ADI with a four hour dosing interval at 3 visits (one treatment per visit) in Part A and a single dose at 2 visits (one treatment per visit) in Part B and C. Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo or GSK2339345 at each visit period in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit of Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
11154046|NCT01899768|FG000|Participant Flow|GSK2339345 1000 µg|Participants received two doses of either GSK2339345 1000 µg or matching placebo as a solution administered via an ADI with a four hour dosing interval at 3 visits (one treatment per visit) in Part A and a single dose at 2 visits (one treatment per visit) in Part B and C. Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo or GSK2339345 at each visit period in Part B and C, participants received an oral inhalation of 10 microliter (µL) of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit of Part C. The strength of capsaicin solution ranged from 0.49 to 1000 micromolar (µM) and the citric acid solution strength ranged from 0.03 to 4.0 molar.
11154047|NCT01899768|OG000|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
11154048|NCT01899768|OG001|Outcome|GSK2339345 1000 Microgram (mcg)|Participants received two doses of GSK2339345 1000 mcg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
11154049|NCT01899768|OG001|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
11154050|NCT01899768|OG000|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
11154051|NCT01899768|EG000|Reported Event|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
11154052|NCT01899768|EG001|Reported Event|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
11154053|NCT01899911|BG000|Baseline|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
11154054|NCT01899911|FG000|Participant Flow|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
11154055|NCT01899911|OG000|Outcome|Vital Signs Patch (VSP)|Infrared and Red absorbance measurement on chest
11154056|NCT01899911|EG000|Reported Event|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
11154057|NCT01900054|BG000|Baseline|TAU-284|TAU-284 10mg twice daily for 12 weeks
11154058|NCT01900054|FG000|Participant Flow|TAU-284|TAU-284 10mg twice daily for 12 weeks
11154059|NCT01900054|OG000|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
11154060|NCT01900054|EG000|Reported Event|TAU-284|TAU-284 10mg twice daily for 12 weeks
11154061|NCT01900067|BG000|Baseline|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
11154062|NCT01900067|BG001|Baseline|Control|no active warming, standard of care
11154063|NCT01900067|BG002|Baseline|Total|Total of all reporting groups
11154064|NCT01900067|FG000|Participant Flow|Active Warming|"BARRIER® EasyWarm Active Self-Warming Blanket~BARRIER® EasyWarm Active Self-Warming Blanket"
11154065|NCT01900067|FG001|Participant Flow|Control|no active warming, standard of care
11154066|NCT01900067|OG000|Outcome|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
11154067|NCT01900067|OG001|Outcome|Control|No active warming, standard of care
11154068|NCT01900067|EG000|Reported Event|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
11154069|NCT01900067|EG001|Reported Event|Control|No active warming, standard of care
11154070|NCT01900249|BG000|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
11154071|NCT01900249|BG001|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
11154072|NCT01900249|BG002|Baseline|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
11154073|NCT01900249|BG003|Baseline|Total|Total of all reporting groups
11154074|NCT01900249|FG000|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
11154075|NCT01900249|FG001|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
11154076|NCT01900249|FG002|Participant Flow|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
11154077|NCT01900249|OG000|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
11154078|NCT01900249|OG001|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
11154079|NCT01900249|OG002|Outcome|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
11154080|NCT01900249|EG000|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
11154081|NCT01900249|EG001|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
11154082|NCT01900249|EG002|Reported Event|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
11154083|NCT01900314|BG000|Baseline|Active rTMS|20 active sessions
11154084|NCT01900314|BG001|Baseline|Sham rTMS|20 sham sessions
11154085|NCT01900314|BG002|Baseline|Total|Total of all reporting groups
11154086|NCT01900314|FG000|Participant Flow|Active rTMS|"20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second functional magnetic resonance imaging scan will be completed then 5 additional tapering treatments of rTMS over a 2 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
11154087|NCT01900314|FG001|Participant Flow|Sham rTMS|"20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second functional magnetic resonance imaging scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
11154088|NCT01900314|OG000|Outcome|Active rTMS|20 active sessions of rTMS
11154089|NCT01900314|OG001|Outcome|Sham rTMS|20 sham sessions
11154090|NCT01900314|OG000|Outcome|Active rTMS|20 active sessions
11154091|NCT01900314|EG000|Reported Event|Active rTMS|"20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
11228150|NCT02388347|EG002|Reported Event|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
11154092|NCT01900314|EG001|Reported Event|Sham rTMS|"20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
11154093|NCT01900392|BG000|Baseline|Lottery|"In addition to the incentives for the 3-, 6-, 9-, & 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.~Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required."
11154094|NCT01900392|BG001|Baseline|Direct Payment|In addition to the incentives for the 3-, 6-, 9-, & 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.
11154095|NCT01900392|BG002|Baseline|Control|No other financial incentive other than for the 3-, 6-, 9-, & 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.
11154096|NCT01900392|BG003|Baseline|Total|Total of all reporting groups
11154097|NCT01900392|FG000|Participant Flow|Control Arm|No other financial incentive other than for the 3-, 6-, 9-, & 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.
11154098|NCT01900392|FG001|Participant Flow|Direct Payment|"In addition to the incentives for the 3-, 6-, 9-, & 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.~Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.~Financial incentive: Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail."
11154099|NCT01900392|FG002|Participant Flow|Lottery|"In addition to the incentives for the 3-, 6-, 9-, & 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.~Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required."
11154100|NCT01900392|OG000|Outcome|Control Arm|No other financial incentive other than for the 3-, 6-, 9-, & 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.
11154101|NCT01900392|OG001|Outcome|Direct Payment|"In addition to the incentives for the 3-, 6-, 9-, & 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.~Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.~Financial incentive: Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail."
11154102|NCT01900392|OG002|Outcome|Lottery|"In addition to the incentives for the 3-, 6-, 9-, & 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.~Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required."
11228151|NCT02388347|EG003|Reported Event|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
11228152|NCT02388347|EG004|Reported Event|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
11154103|NCT01900392|EG000|Reported Event|Lottery|"In addition to the incentives for the 3-, 6-, 9-, & 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.~Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required."
11154104|NCT01900392|EG001|Reported Event|Direct Payment|"In addition to the incentives for the 3-, 6-, 9-, & 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.~Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required."
11154105|NCT01900392|EG002|Reported Event|Control|No other financial incentive other than for the 3-, 6-, 9-, & 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.
11154106|NCT01900431|BG000|Baseline|Placebo|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
11154107|NCT01900431|BG001|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
11154108|NCT01900431|BG002|Baseline|Total|Total of all reporting groups
11154109|NCT01900431|FG000|Participant Flow|Placebo|Placebo (for Sarilumab) subcutaneous (SC) injection every 2 weeks (q2w) for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with Methotrexate (MTX) 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
11154110|NCT01900431|FG001|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
11154111|NCT01900431|FG002|Participant Flow|Sarilumab 200 mg q2w (Open-Label Treatment)|Non-responders and non-completers observed in Part A were treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
11154112|NCT01900431|OG000|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
11154113|NCT01900431|OG001|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
11154114|NCT01900431|OG000|Outcome|Sarilumab 200 mg q2w (Part A + Part B)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
11154115|NCT01900431|EG000|Reported Event|Placebo (Part A + Part B)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
11154116|NCT01900431|EG001|Reported Event|Sarilumab 200 mg q2w (Part A+ Part B)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
11154117|NCT01900431|EG002|Reported Event|Sarilumab 200 mg q2w: Open-Label Treatment (Part C)|Non-responders and non-completers observed in Part A were proposed to be treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part-C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
11154118|NCT01900561|BG000|Baseline|IVR Intervention|The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.
11154119|NCT01900561|BG001|Baseline|Enhanced Usual Care|Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors.
11154120|NCT01900561|BG002|Baseline|Total|Total of all reporting groups
11154121|NCT01900561|FG000|Participant Flow|IVR Intervention|The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.
11154122|NCT01900561|FG001|Participant Flow|Enhanced Usual Care|Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors.
11154123|NCT01900561|OG000|Outcome|IVR Intervention|The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.
11154124|NCT01900561|OG001|Outcome|Enhanced Usual Care|Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors.
11154125|NCT01900561|EG000|Reported Event|IVR Intervention|The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.
11228153|NCT02388386|BG000|Baseline|PROTEUS-SENSOR|10 consecutive heart failure patients with continuous flow left ventricular devices
11233839|NCT02431273|BG000|Baseline|All Study Participants|"All subjects will be asked to wear Single (TDF) IVRs for 7 days.~If the TDF IVR is determined as safe, study participants will be asked to replace it with Dual (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.~If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with Triple (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR."
10887708|NCT00502593|BG007|Baseline|Fluarix-B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11154126|NCT01900561|EG001|Reported Event|Enhanced Usual Care|Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors.
11154127|NCT01900652|BG000|Baseline|Arm A: Emibetuzumab Plus Erlotinib|750 milligram (mg) Emibetuzumab (LY2875358) flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
11154128|NCT01900652|BG001|Baseline|Arm B: Emibetuzumab|750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
11154129|NCT01900652|BG002|Baseline|Total|Total of all reporting groups
11154130|NCT01900652|FG000|Participant Flow|Arm A: Emibetuzumab Plus Erlotinib|750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
11154131|NCT01900652|FG001|Participant Flow|Arm B: Emibetuzumab 750mg|750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
11154132|NCT01900652|OG000|Outcome|Arm A: Emibetuzumab Plus Erlotinib|750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
11154133|NCT01900652|OG001|Outcome|Arm B: Emibetuzumab|750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
11154134|NCT01900652|OG002|Outcome|MET-High Analysis Population (Emibetuzumab + Erlotinib)|Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
11154135|NCT01900652|OG003|Outcome|MET-High Analysis Population (Emibetuzumab)|Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
11154136|NCT01900652|OG001|Outcome|Arm B: LY2875358|750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
11154137|NCT01900652|OG002|Outcome|MET-High Analysis Population|Participants with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
11154138|NCT01900652|OG000|Outcome|Emibetuzumab|All participants who received Emibetuzumab on Cycle 1, Day 1, and contributed samples for analysis.
11154139|NCT01900652|EG000|Reported Event|Arm A: Emibetuzumab Plus Erlotinib|750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
11154140|NCT01900652|EG001|Reported Event|Arm B: Emibetuzumab|750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
11154141|NCT01900665|BG000|Baseline|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
11154142|NCT01900665|BG001|Baseline|Placebo|"Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.~Placebo: Administered IV"
11154143|NCT01900665|BG002|Baseline|Total|Total of all reporting groups
11154144|NCT01900665|FG000|Participant Flow|Solanezumab|Participants received Solanezumab 400 milligrams (mg)Intravenously (IV) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
11154145|NCT01900665|FG001|Participant Flow|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
11154146|NCT01900665|OG000|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
11154147|NCT01900665|OG001|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
11154148|NCT01900665|OG001|Outcome|Placebo|"Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.~Placebo: Administered IV"
11154149|NCT01900665|EG000|Reported Event|Solanezumab: Double-Blind Phase|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
11154150|NCT01900665|EG001|Reported Event|Placebo: Double-Blind Phase|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
11154151|NCT01900665|EG002|Reported Event|Solanezumab: Open Label|Participants who complete 80 weeks treatment/assessment of the double-blind period were entered into open-label period. Participants received Solanezumab 400 mg IV every 4 weeks for 180 weeks with an additional 4 weeks of assessments.
11154152|NCT01900665|EG003|Reported Event|Placebo: Open Label|Participants who complete 80 weeks treatment/assessment of the double-blind period were entered into open-label period. Participants received Placebo IV every 4 weeks for 180 weeks with an additional 4 weeks of assessments.
11154153|NCT01900704|BG000|Baseline|SER120 750 ng|All participants received SER120 750 ng once daily
11154154|NCT01900704|BG001|Baseline|SER120 1500 ng|All participants received SER120 1500 ng once daily
11154155|NCT01900704|BG002|Baseline|Placebo|All participants received Placebo once daily
11154156|NCT01900704|BG003|Baseline|Total|Total of all reporting groups
11154157|NCT01900704|FG000|Participant Flow|SER120 1500 ng|All participants received SER120 1500 ng once daily
11154158|NCT01900704|FG001|Participant Flow|SER120 750 ng|All participant received SER120 750 ng once daily
11154159|NCT01900704|FG002|Participant Flow|Placebo|All participants received Placebo once daily
11154160|NCT01900704|OG000|Outcome|SER120 750 ng|All participants received SER120 750 ng once daily
11154161|NCT01900704|OG001|Outcome|SER120 1500 ng|All participants received SER120 1500 ng once daily
11154162|NCT01900704|OG002|Outcome|Placebo|All participants received Placebo once daily
11154163|NCT01900704|OG001|Outcome|SER120 1500 ng|All participant received SER120 1500 ng once daily
11154164|NCT01900704|EG000|Reported Event|SER120 750 ng|All participants received SER120 750 ng once daily
11154165|NCT01900704|EG001|Reported Event|SER120 1500 ng|All participants received SER120 1500 ng once daily
11154166|NCT01900704|EG002|Reported Event|Placebo|All participants received Placebo once daily
11154167|NCT01900899|BG000|Baseline|MenACWY-TT Vaccine|Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
11154168|NCT01900899|BG001|Baseline|MenCCRM Vaccine|Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
11154169|NCT01900899|BG002|Baseline|Total|Total of all reporting groups
11154170|NCT01900899|FG000|Participant Flow|MenACWY-TT Vaccine|Participants who received single 0.5 milliliter (mL) dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
11154171|NCT01900899|FG001|Participant Flow|MenCCRM Vaccine|Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
11154172|NCT01900899|OG000|Outcome|MenACWY-TT Vaccine|Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
11154173|NCT01900899|OG001|Outcome|MenCCRM Vaccine|Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
11154174|NCT01900899|EG000|Reported Event|MenACWY-TT Vaccine|Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
11154175|NCT01900899|EG001|Reported Event|MenCCRM Vaccine|Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
11154176|NCT01901055|BG000|Baseline|Active CPAP Treatment|"Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)~CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).~Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)"
11154177|NCT01901055|BG001|Baseline|Sham-CPAP|"Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.~Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).~Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)"
11154178|NCT01901055|BG002|Baseline|Total|Total of all reporting groups
11154179|NCT01901055|FG000|Participant Flow|Active CPAP Treatment|"Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)~CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).~Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)"
11349150|NCT04116684|OG001|Outcome|Intervention Group (Digital BP Monitoring)|"This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments.~Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone."
11154180|NCT01901055|FG001|Participant Flow|Sham-CPAP|"Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.~Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).~Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)"
11154181|NCT01901055|OG000|Outcome|Active CPAP Treatment|Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
11154182|NCT01901055|OG001|Outcome|Sham-CPAP Treatment|Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
11154183|NCT01901055|OG000|Outcome|Active CPAP Treatment|"Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)~CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).~Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)"
11154184|NCT01901055|OG001|Outcome|Sham-CPAP|"Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.~Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).~Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)"
11154185|NCT01901055|EG000|Reported Event|Active CPAP Treatment|"Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)~CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).~Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)"
11154186|NCT01901055|EG001|Reported Event|Sham-CPAP|"Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.~Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).~Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)"
11154187|NCT01901055|EG002|Reported Event|Active CPAP Following Sham-CPAP|Persons who completed 12-weeks on sham-CPAP, were debriefed, titrated for active CPAP
11154188|NCT01901146|BG000|Baseline|ABP 980|Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
11154189|NCT01901146|BG001|Baseline|Trastuzumab|Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
11154190|NCT01901146|BG002|Baseline|Total|Total of all reporting groups
11154191|NCT01901146|FG000|Participant Flow|ABP 980|Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
11154192|NCT01901146|FG001|Participant Flow|Trastuzumab|Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
11154193|NCT01901146|FG002|Participant Flow|ABP 980/ABP 980|After surgery, participants initially randomized to ABP 980 continued to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
11154194|NCT01901146|FG003|Participant Flow|Trastuzumab/Trastuzumab|After surgery, participants originally randomized to trastuzumab were re-randomized and continued to receive trastuzumab at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
11154195|NCT01901146|FG004|Participant Flow|Trastuzumab/ABP 980|After surgery, participants originally randomized to trastuzumab were re-randomized and switched to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
11154196|NCT01901146|OG000|Outcome|ABP 980|Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
11154197|NCT01901146|OG001|Outcome|Trastuzumab|Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
11154198|NCT01901146|EG000|Reported Event|Neoadjuvant Phase: ABP 980|Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
11154199|NCT01901146|EG001|Reported Event|Neoadjuvant Phase: Trastuzumab|Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
11154200|NCT01901146|EG002|Reported Event|Adjuvant Phase: ABP 980/ABP 980|After surgery, participants initially randomized to ABP 980 continued to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
11154201|NCT01901146|EG003|Reported Event|Adjuvant Phase: Trastuzumab/Trastuzumab|After surgery, participants originally randomized to trastuzumab were re-randomized and continued to receive trastuzumab at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
11154202|NCT01901146|EG004|Reported Event|Adjuvant Phase: Trastuzumab/ABP 980|After surgery, participants originally randomized to trastuzumab were re-randomized and switched to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
11154203|NCT01901185|BG000|Baseline|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
11154204|NCT01901185|FG000|Participant Flow|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
11154205|NCT01901185|OG000|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
11154206|NCT01901185|EG000|Reported Event|Autoinjector A/Etanercept|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week at Weeks 1 - 5 (total of 6 injections).
11154207|NCT01901211|BG000|Baseline|Exergaming First, Then Comparison|"In this arm, the participants will participate in the exergaming intervention during the first ten-week then after 6-week washout, will participate in the comparison activities during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
11154208|NCT01901211|BG001|Baseline|Comparison First, Then Exergaming|"In this arm of the study, participants will complete comparison activities during the first ten-week then after 6-week washout, will participate in the exergaming intervention during the second ten-week period.~Participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
11154209|NCT01901211|BG002|Baseline|Total|Total of all reporting groups
11154210|NCT01901211|FG000|Participant Flow|Exergaming First, Then Comparison|"In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
11154211|NCT01901211|FG001|Participant Flow|Comparison First, Then Exergaming|"In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.~participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
11154212|NCT01901211|OG000|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
11154213|NCT01901211|OG001|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
11349151|NCT04116684|EG000|Reported Event|Standard of Care BP Monitoring|This group will use a standard BP cuff and record and transmit data to their medical team as instructed by their providers or if they are concerned.
11154214|NCT01901211|EG000|Reported Event|Exergaming|"In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
11154215|NCT01901211|EG001|Reported Event|Comparison Arm|"In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.~participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
11154216|NCT01901250|BG000|Baseline|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
11154217|NCT01901250|BG001|Baseline|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
11154218|NCT01901250|BG002|Baseline|Total|Total of all reporting groups
11154219|NCT01901250|FG000|Participant Flow|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
11154220|NCT01901250|FG001|Participant Flow|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
11154221|NCT01901250|OG000|Outcome|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
11154222|NCT01901250|OG001|Outcome|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
11154223|NCT01901250|EG000|Reported Event|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
11233840|NCT02431273|FG000|Participant Flow|TDF (Single IVR), TDF-FTC (Dual IVR), TDF-FTC-MVC (Triple IVR)|"All subjects will be asked to wear TDF (Single) IVRs for 7 days.~If the TDF IVR is determined as safe, study participants will be asked to replace it with Dual (TDF-FTC) IVRs for 7 days.~If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with Triple (TDF-FTC-MVC) IVRs for 7 days."
11233841|NCT02431273|OG000|Outcome|Period 1: TDF (Single IVR)|"All subjects will be asked to wear Single (TDF) IVRs for 7 days.~TDF IVR"
11154224|NCT01901250|EG001|Reported Event|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
11154225|NCT01901302|BG000|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154226|NCT01901302|BG001|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
11154227|NCT01901302|BG002|Baseline|Total|Total of all reporting groups
11154228|NCT01901302|FG000|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period
11154229|NCT01901302|FG001|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
11154230|NCT01901302|OG000|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154231|NCT01901302|OG001|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
11154232|NCT01901302|EG000|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154233|NCT01901302|EG001|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
11154234|NCT01901328|BG000|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154235|NCT01901328|BG001|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
11154236|NCT01901328|BG002|Baseline|Total|Total of all reporting groups
11154237|NCT01901328|FG000|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period
11154238|NCT01901328|FG001|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
11154239|NCT01901328|OG000|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154240|NCT01901328|OG001|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
11154241|NCT01901328|OG000|Outcome|CB-5945|0.25 milligrams CB-5945 administered orally BID for a 12-week treatment period
11154242|NCT01901328|EG000|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154243|NCT01901328|EG001|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
11154244|NCT01901341|BG000|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154245|NCT01901341|BG001|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
11154246|NCT01901341|BG002|Baseline|Total|Total of all reporting groups
11154247|NCT01901341|FG000|Participant Flow|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154248|NCT01901341|FG001|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
11154249|NCT01901341|OG000|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154250|NCT01901341|OG001|Outcome|Placebo|Placebo administered orally BID for a12-week treatment period
11154251|NCT01901341|OG001|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
11154252|NCT01901341|EG000|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
11154253|NCT01901341|EG001|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
11154254|NCT01901393|BG000|Baseline|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
11154255|NCT01901393|BG001|Baseline|Ketorolac|"30mg ketorolac~Ketorolac"
11154256|NCT01901393|BG002|Baseline|Total|Total of all reporting groups
11154257|NCT01901393|FG000|Participant Flow|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
11154258|NCT01901393|FG001|Participant Flow|Ketorolac|"30mg ketorolac~Ketorolac"
11154259|NCT01901393|OG000|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
11154260|NCT01901393|OG001|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
11154261|NCT01901393|EG000|Reported Event|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
11154262|NCT01901393|EG001|Reported Event|Ketorolac|"30mg ketorolac~Ketorolac"
11154263|NCT01901419|BG000|Baseline|High-dose NTG|"Nitroglycerin infusion 1-5 mcg/kg/min~Nitroglycerin infusion: Nitroglycerin infusion during rewarming"
11154264|NCT01901419|BG001|Baseline|Low-dose NTG|"Nitroglycerin infusion 0-0.1 mcg/kg/min~Nitroglycerin infusion: Nitroglycerin infusion during rewarming"
11154265|NCT01901419|BG002|Baseline|Total|Total of all reporting groups
11154266|NCT01901419|FG000|Participant Flow|High-dose NTG|"Nitroglycerin infusion 1-5 mcg/kg/min~Nitroglycerin infusion: Nitroglycerin infusion during rewarming"
11154267|NCT01901419|FG001|Participant Flow|Low-dose NTG|"Nitroglycerin infusion 0-0.1 mcg/kg/min~Nitroglycerin infusion: Nitroglycerin infusion during rewarming"
11154268|NCT01901419|OG000|Outcome|High-dose NTG|"Nitroglycerin infusion 1-5 mcg/kg/min~Nitroglycerin infusion: Nitroglycerin infusion during rewarming"
11154269|NCT01901419|OG001|Outcome|Low-dose NTG|"Nitroglycerin infusion 0-0.1 mcg/kg/min~Nitroglycerin infusion: Nitroglycerin infusion during rewarming"
11154270|NCT01901419|EG000|Reported Event|High-dose NTG|"Nitroglycerin infusion 1-5 mcg/kg/min~Nitroglycerin infusion: Nitroglycerin infusion during rewarming"
11154271|NCT01901419|EG001|Reported Event|Low-dose NTG|"Nitroglycerin infusion 0-0.1 mcg/kg/min~Nitroglycerin infusion: Nitroglycerin infusion during rewarming"
11154272|NCT01901575|BG000|Baseline|Remifentanil|Remifentanil IV PCA
11154273|NCT01901575|FG000|Participant Flow|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
11154274|NCT01901575|OG000|Outcome|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
11154275|NCT01901575|OG000|Outcome|Remifentanil IV PCA|"patients with PVC's prior to administration of remifentanil~Remifentanil: Patients with established PVC's , sedated with remifentanil IVPCA per study protocol"
11154276|NCT01901575|EG000|Reported Event|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
11154277|NCT01901588|BG000|Baseline|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
11154278|NCT01901588|BG001|Baseline|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
11154279|NCT01901588|BG002|Baseline|Total|Total of all reporting groups
11154280|NCT01901588|FG000|Participant Flow|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
11154281|NCT01901588|FG001|Participant Flow|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
11154282|NCT01901588|OG000|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
11154283|NCT01901588|OG001|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
11154284|NCT01901588|EG000|Reported Event|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
11154285|NCT01901588|EG001|Reported Event|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
11154286|NCT01901614|BG000|Baseline|Laser-assisted Lamellar Anterior Keratoplasty|"LALAK: a. A dovetail shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface.~b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite.~optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections.~Topical Anesthesia~femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty."
11154287|NCT01901614|BG001|Baseline|Intralase-enabled Keratoplasty|"IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.~b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed.~Retrobulbar Block or General Anesthesia~femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication."
11154288|NCT01901614|BG002|Baseline|Total|Total of all reporting groups
11154289|NCT01901614|FG000|Participant Flow|Laser-assisted Lamellar Anterior Keratoplasty|"Laser-assisted lamellar anterior keratoplasty~LALAK: a. A dovetail shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface.~b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite.~optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections.~Topical Anesthesia~femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA)."
11349152|NCT04116684|EG001|Reported Event|Intervention Group (Digital BP Monitoring)|"This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments.~Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone."
11154290|NCT01901614|FG001|Participant Flow|Intralase-enabled Keratoplasty|"Intralase-enabled keratoplasty.~IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.~b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed.~Retrobulbar Block or General Anesthesia~femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication."
11154291|NCT01901614|OG000|Outcome|Laser-assisted Lamellar Anterior Keratoplasty|"LALAK: a. A dovetail shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface.~b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite.~optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections.~Topical Anesthesia~femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty."
11174305|NCT02020785|FG001|Participant Flow|Lower Phosphorus Period First, Then Higher Phosphorus Period|"Randomized to higher phosphorus period first, then lower phosphorus period second.~Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks~At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives~Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks~Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) given for 3 weeks"
11154292|NCT01901614|OG001|Outcome|Intralase-enabled Keratoplasty|"IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.~b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed.~Retrobulbar Block or General Anesthesia~femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication."
11154293|NCT01901614|EG000|Reported Event|Laser-assisted Lamellar Anterior Keratoplasty|"LALAK: a. A dovetail shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface.~b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite.~optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections.~Topical Anesthesia~femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty."
11154294|NCT01901614|EG001|Reported Event|Intralase-enabled Keratoplasty|"IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.~b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed.~Retrobulbar Block or General Anesthesia~femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication."
11154295|NCT01901653|BG000|Baseline|Phase 1a: Cohort 1 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
11154296|NCT01901653|BG001|Baseline|Phase 1a: Cohort 2 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
11154297|NCT01901653|BG002|Baseline|Phase 1a: Cohort 3 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154298|NCT01901653|BG003|Baseline|Phase 1a: Cohort 4 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
11154299|NCT01901653|BG004|Baseline|Phase 1a: Cohort 5 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
11154300|NCT01901653|BG005|Baseline|Phase 1a: Cohort 6 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
11154301|NCT01901653|BG006|Baseline|Phase 1a: Cohort 7 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
11154302|NCT01901653|BG007|Baseline|Phase 1a: Cohort 8 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154303|NCT01901653|BG008|Baseline|Phase 1a: Cohort 8 (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154304|NCT01901653|BG009|Baseline|Phase 1b: Retreatment (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
11154305|NCT01901653|BG010|Baseline|Phase 1b: Retreatment (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
11154306|NCT01901653|BG011|Baseline|Phase 1b: Maintenance (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
11154307|NCT01901653|BG012|Baseline|Phase 1b: Maintenance (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
11154308|NCT01901653|BG013|Baseline|Total|Total of all reporting groups
11154309|NCT01901653|FG000|Participant Flow|Phase 1a: Cohort 1 Small Cell Lung Cancer (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
11154310|NCT01901653|FG001|Participant Flow|Phase 1a: Cohort 2 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
11154311|NCT01901653|FG002|Participant Flow|Phase 1a: Cohort 3 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154312|NCT01901653|FG003|Participant Flow|Phase 1a: Cohort 4 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
11154313|NCT01901653|FG004|Participant Flow|Phase 1a: Cohort 5 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
11154314|NCT01901653|FG005|Participant Flow|Phase 1a: Cohort 6 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
11154315|NCT01901653|FG006|Participant Flow|Phase 1a: Cohort 7 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
11154316|NCT01901653|FG007|Participant Flow|Phase 1a: Cohort 8 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154317|NCT01901653|FG008|Participant Flow|Phase 1a: Cohort 8 Large Cell Neuroendocrine Carcinoma (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11233842|NCT02431273|OG001|Outcome|Period 2: TDF-FTC (Dual IVR)|"If the TDF IVR is determined as safe, study participants will be asked to replace it with Dual (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.~TDF-FTC IVR"
11089091|NCT01521884|FG000|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
11089092|NCT01521884|OG000|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
11089093|NCT01521884|EG000|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
11089094|NCT01521897|BG000|Baseline|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
11089095|NCT01521897|FG000|Participant Flow|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
11089096|NCT01521897|OG000|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
11089097|NCT01521897|EG000|Reported Event|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
11089098|NCT01521923|BG000|Baseline|PBO+MTX / PBO+MTX|Placebo (PBO) + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
11089099|NCT01521923|BG001|Baseline|CZP+MTX / PBO+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
11089100|NCT01521923|BG002|Baseline|CZP+MTX / CZP Q4W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2
11089101|NCT01521923|BG003|Baseline|CZP+MTX / CZP Q2W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2
11089102|NCT01521923|BG004|Baseline|Total Title|
11089103|NCT01521923|FG000|Participant Flow|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
11089104|NCT01521923|FG001|Participant Flow|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
11089105|NCT01521923|FG002|Participant Flow|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
11089106|NCT01521923|FG003|Participant Flow|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
11089107|NCT01521923|OG000|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set [FAS])|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
11089108|NCT01521923|OG001|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
11089109|NCT01521923|OG002|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
11089110|NCT01521923|OG000|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
11089111|NCT01521923|OG000|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
11089112|NCT01521923|OG001|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
11154318|NCT01901653|FG009|Participant Flow|Phase 1b: Retreatment (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
11154319|NCT01901653|FG010|Participant Flow|Phase 1b: Retreatment (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
11154320|NCT01901653|FG011|Participant Flow|Phase 1b: Maintenance (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
11154321|NCT01901653|FG012|Participant Flow|Phase 1b: Maintenance (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
11154322|NCT01901653|OG000|Outcome|Rovalpituzumab Tesirine|Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
11154323|NCT01901653|OG000|Outcome|SCLC Subjects|SCLC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
11154324|NCT01901653|OG001|Outcome|LCNEC Subjects|LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
11154325|NCT01901653|OG000|Outcome|Phase 1a: Cohort 1|All Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
11154326|NCT01901653|OG001|Outcome|Phase 1a: Cohort 2|All Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
11154327|NCT01901653|OG002|Outcome|Phase 1a: Cohort 3|All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154328|NCT01901653|OG003|Outcome|Phase 1a: Cohort 4|All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
11154329|NCT01901653|OG004|Outcome|Phase 1a: Cohort 5|All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
11154330|NCT01901653|OG005|Outcome|Phase 1a: Cohort 6|All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
11154331|NCT01901653|OG006|Outcome|Phase 1a: Cohort 7|All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
11154332|NCT01901653|OG007|Outcome|Phase 1a: Cohort 8|All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154333|NCT01901653|EG000|Reported Event|Phase 1a: Cohort 1 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
11154334|NCT01901653|EG001|Reported Event|Phase 1a: Cohort 2 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
11154335|NCT01901653|EG002|Reported Event|Phase 1a: Cohort 3 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154336|NCT01901653|EG003|Reported Event|Phase 1a: Cohort 4 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
11154337|NCT01901653|EG004|Reported Event|Phase 1a: Cohort 5 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
11154338|NCT01901653|EG005|Reported Event|Phase 1a: Cohort 6 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
11154339|NCT01901653|EG006|Reported Event|Phase 1a: Cohort 7 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
11154340|NCT01901653|EG007|Reported Event|Phase 1a: Cohort 8 (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154341|NCT01901653|EG008|Reported Event|Phase 1a: Cohort 8 (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
11154342|NCT01901653|EG009|Reported Event|Phase 1b: Retreatment (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
11154343|NCT01901653|EG010|Reported Event|Phase 1b: Retreatment (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
11154344|NCT01901653|EG011|Reported Event|Phase 1b: Maintenance (SCLC)|SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
11154345|NCT01901653|EG012|Reported Event|Phase 1b: Maintenance (LCNEC)|LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
11154346|NCT01901809|BG000|Baseline|Bolus Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).~Furosemide"
11154347|NCT01901809|BG001|Baseline|Continuous Infusion Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).~Furosemide"
11154348|NCT01901809|BG002|Baseline|Bolus Furosemide Plus Dopamine|"Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
11154349|NCT01901809|BG003|Baseline|Continuous Furosemide Plus Dopamine|"Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
11154350|NCT01901809|BG004|Baseline|Total|Total of all reporting groups
11154351|NCT01901809|FG000|Participant Flow|Bolus Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).~Furosemide"
11154352|NCT01901809|FG001|Participant Flow|Continuous Infusion Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).~Furosemide"
11154353|NCT01901809|FG002|Participant Flow|Bolus Furosemide Plus Dopamine|"Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
11154354|NCT01901809|FG003|Participant Flow|Continuous Furosemide Plus Dopamine|"Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
11154355|NCT01901809|OG000|Outcome|Bolus Furosemide and no Dopamine|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).~Furosemide"
11154356|NCT01901809|OG001|Outcome|Continuous Infusion Furosemide and no Dopamine|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).~Furosemide"
11154357|NCT01901809|OG002|Outcome|Bolus Furosemide Plus Dopamine|"Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min~Furosemide~Dopamine"
11154358|NCT01901809|OG003|Outcome|Continuous Furosemide Plus Dopamine|"Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min~Furosemide~Dopamine"
11154359|NCT01901809|OG000|Outcome|Bolus Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily)."
11154360|NCT01901809|OG001|Outcome|Continuous Infusion Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs)."
11154361|NCT01901809|OG000|Outcome|Dopamine|Diuretic therapy plus addition of dopamine at 3 µg/kg/min administered as an infusion.
11154362|NCT01901809|OG001|Outcome|No Dopamine|Diuretic therapy only
11154363|NCT01901809|EG000|Reported Event|Bolus Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).~Furosemide"
11154364|NCT01901809|EG001|Reported Event|Continuous Infusion Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).~Furosemide"
11154365|NCT01901809|EG002|Reported Event|Bolus Furosemide Plus Dopamine|"Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
11154366|NCT01901809|EG003|Reported Event|Continuous Furosemide Plus Dopamine|"Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
11154367|NCT01901848|BG000|Baseline|CPT+ICSC|"This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.~Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning.~Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.~nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,"
11154368|NCT01901848|BG001|Baseline|Present-focused ICSC|"This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.~Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.~nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.~Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.~smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking."
11154369|NCT01901848|BG002|Baseline|Total|Total of all reporting groups
11154370|NCT01901848|FG000|Participant Flow|CPT+ICSC|"This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.~Cognitive Processing Therapy (CPT): CPT is based on a social cognitive theory of PTSD that includes primary emotional responses to traumatic events such as fear, anger, and sadness, as well as secondary emotions resulting from a patient's faulty interpretations of the traumatic event. CPT addresses PTSD by facilitating affective expression so that affective components of the trauma memory can be altered. In addition, faulty beliefs about the trauma are challenged and modified using Socratic questioning.~Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.~nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,"
11154371|NCT01901848|FG001|Participant Flow|Present-focused ICSC|"This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.~Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.~nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.~Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.~smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking."
11154372|NCT01901848|OG000|Outcome|CPT+ICSC|"This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.~Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning.~Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.~nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,"
11154373|NCT01901848|OG001|Outcome|Present-focused ICSC|"This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.~Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.~nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.~Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.~smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking."
11154374|NCT01901848|EG000|Reported Event|CPT+ICSC|"This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.~Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning.~Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.~nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,"
11154375|NCT01901848|EG001|Reported Event|Present-focused ICSC|"This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.~Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.~nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.~Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.~smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking."
11154376|NCT01901874|BG000|Baseline|Carotid Artery Stenting|"Carotid Artery Stenting with the GORE® Carotid Stent~Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent"
11154377|NCT01901874|FG000|Participant Flow|Carotid Artery Stenting|"Carotid Artery Stenting with the GORE® Carotid Stent~Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent"
11154378|NCT01901874|OG000|Outcome|Carotid Artery Stenting|"Carotid Artery Stenting with the GORE® Carotid Stent~Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent"
11154379|NCT01901874|EG000|Reported Event|Carotid Artery Stenting|"Carotid Artery Stenting with the GORE® Carotid Stent~Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent"
11233843|NCT02431273|OG002|Outcome|Period 3: TDF-FTC-MVC (Triple IVR)|"If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with Triple (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.~TDF-FTC-MVC IVR"
11233844|NCT02431273|EG000|Reported Event|TDF (Single IVR)|"All subjects will be asked to wear Single (TDF) IVRs for 7 days.~TDF IVR"
11228154|NCT02388386|FG000|Participant Flow|PROTEUS-SENSOR|"The current study is a prospective interventional design with a single experimental arm. The intervention consists of two components: an edible sensor and a wearable receiver health monitor.~PROTEUS-SENSOR: An edible sensor system, Proteus Digital™ has been developed for electronically confirming medication adherence, gathering physiologic metrics and communicating these data to patients. The system consists of two major components: an edible sensor and a wearable receiver health monitor. An electrical signal is activated upon ingestion of the Proteus Digital micro-sensor with transmission of this signal to a receiving abdominal patch to quantify medication compliance."
11228155|NCT02388386|OG000|Outcome|Outcome Measure|Positive detection rate of 80%
11228156|NCT02388386|OG000|Outcome|Vital Signs|Safety as measured by vital signs
11089113|NCT01521923|OG002|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
11089114|NCT01521923|EG000|Reported Event|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
11089115|NCT01521923|EG001|Reported Event|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
11089116|NCT01521923|EG002|Reported Event|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
11089117|NCT01521923|EG003|Reported Event|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
11089118|NCT01521949|BG000|Baseline|Acai Juice|"2 ounces of Acai Juice Product by mouth twice daily.~Acai Juice Product: 2 ounces of Acai Juice Product twice daily."
11089119|NCT01521949|FG000|Participant Flow|Acai Juice|"2 ounces of Acai Juice Product by mouth twice daily.~Acai Juice Product: 2 ounces of Acai Juice Product twice daily."
11089120|NCT01521949|OG000|Outcome|Acai Juice|"2 ounces of Acai Juice Product by mouth twice daily.~Acai Juice Product: 2 ounces of Acai Juice Product twice daily."
11089121|NCT01521949|EG000|Reported Event|Acai Juice|"2 ounces of Acai Juice Product by mouth twice daily.~Acai Juice Product: 2 ounces of Acai Juice Product twice daily."
11089122|NCT01522131|BG000|Baseline|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
11089123|NCT01522131|BG001|Baseline|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
11089124|NCT01522131|BG002|Baseline|Total|Total of all reporting groups
11089125|NCT01522131|FG000|Participant Flow|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
11089126|NCT01522131|FG001|Participant Flow|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
11089127|NCT01522131|OG000|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
11089128|NCT01522131|OG001|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
11089129|NCT01522131|EG000|Reported Event|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
11089130|NCT01522131|EG001|Reported Event|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
11089131|NCT01522235|BG000|Baseline|Group A|"IVIg~IVIG: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089132|NCT01522235|BG001|Baseline|Group B|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089133|NCT01522235|BG002|Baseline|Total|Total of all reporting groups
11089134|NCT01522235|FG000|Participant Flow|IVIG Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period."
11089135|NCT01522235|FG001|Participant Flow|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period."
11154380|NCT01902004|BG000|Baseline|Escitalopram and Memantine|"Participants will take a combination of Escitalopram and Memantine for 12 months~Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.~Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day."
11154381|NCT01902004|BG001|Baseline|Escitalopram and Placebo|"Participants will take a combination of Escitalopram and placebo for 12 months~Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day."
11154382|NCT01902004|BG002|Baseline|Total|Total of all reporting groups
11154383|NCT01902004|FG000|Participant Flow|Escitalopram and Memantine|"Participants will take a combination of Escitalopram and Memantine for 12 months~Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.~Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day."
11154384|NCT01902004|FG001|Participant Flow|Escitalopram and Placebo|"Participants will take a combination of Escitalopram and placebo for 12 months~Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day."
11154385|NCT01902004|OG000|Outcome|Escitalopram and Memantine|"Participants will take a combination of Escitalopram and Memantine for 12 months~Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.~Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day."
11154386|NCT01902004|OG001|Outcome|Escitalopram and Placebo|"Participants will take a combination of Escitalopram and placebo for 12 months~Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day."
11154387|NCT01902004|EG000|Reported Event|Escitalopram and Memantine|"Participants will take a combination of Escitalopram and Memantine for 12 months~Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.~Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day."
11154388|NCT01902004|EG001|Reported Event|Escitalopram and Placebo|"Participants will take a combination of Escitalopram and placebo for 12 months~Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day."
11154389|NCT01902134|BG000|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
11154390|NCT01902134|BG001|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
11154391|NCT01902134|BG002|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
11154392|NCT01902134|BG003|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
11154393|NCT01902134|BG004|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
11154394|NCT01902134|BG005|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
11154395|NCT01902134|BG006|Baseline|Total|Total of all reporting groups
11154396|NCT01902134|FG000|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
11154397|NCT01902134|FG001|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
11154398|NCT01902134|FG002|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
11154399|NCT01902134|FG003|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
11154400|NCT01902134|FG004|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP
11154401|NCT01902134|FG005|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
11154402|NCT01902134|OG000|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
11154403|NCT01902134|OG001|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
11154404|NCT01902134|OG002|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
11154405|NCT01902134|OG003|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
11154406|NCT01902134|OG000|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
11154407|NCT01902134|OG001|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
11154408|NCT01902134|OG002|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
11154409|NCT01902134|OG003|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours);
11154410|NCT01902134|EG000|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses.
11154411|NCT01902134|EG001|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses.
11154412|NCT01902134|EG002|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses.
11154413|NCT01902134|EG003|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses.
11154414|NCT01902134|EG004|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses.
11154415|NCT01902134|EG005|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses.
11154416|NCT01902303|BG000|Baseline|Matching Placebo|Placebo Safety Population - All subjects enrolled and received placebo test article
11154417|NCT01902303|BG001|Baseline|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and received active test article
11154418|NCT01902303|BG002|Baseline|Total|Total of all reporting groups
11154419|NCT01902303|FG000|Participant Flow|Matching Placebo|"Matching Placebo~Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):~Day 0 - Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.~Days 1 & 2 - Take 1 drop six times daily -~Days 3-7 - Take one drop twice daily"
11154420|NCT01902303|FG001|Participant Flow|BTL-TML-HSV|"Experimental Product~BTL-TML-HSV: Sublingual micro dosing of BTL-TML-HSV for 7 days~Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):~Day 0 - Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.~Days 1 & 2 - Take 1 drop six times daily -~Days 3-7 - Take one drop twice daily"
11154421|NCT01902303|OG000|Outcome|Matching Placebo|Placebo Efficacy Population - All subjects enrolled and received placebo test article and met Per protocol definition
11154422|NCT01902303|OG001|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects enrolled and received active test article and met Per Protocol definition
11154423|NCT01902303|OG000|Outcome|Matching Placebo|Placebo efficacy Population - All subjects who received placebo test article and were compliant with protocol
11154424|NCT01902303|OG001|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects who received active test article and were compliant with protocol
11154425|NCT01902303|EG000|Reported Event|Matching Placebo|Placebo Safety Population - All subjects that enrolled and were allocated to placebo test article except for SAEs and that includes all subjects that signed informed consent.
11154426|NCT01902303|EG001|Reported Event|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent.
11154427|NCT01902459|BG000|Baseline|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11154428|NCT01902459|BG001|Baseline|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
11154429|NCT01902459|BG002|Baseline|Total|Total of all reporting groups
11154430|NCT01902459|FG000|Participant Flow|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11154431|NCT01902459|FG001|Participant Flow|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
11154432|NCT01902459|OG000|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11154433|NCT01902459|OG001|Outcome|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
11154434|NCT01902459|EG000|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11154435|NCT01902459|EG001|Reported Event|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
11154436|NCT01902628|BG000|Baseline|Participants With CKD|This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
11154437|NCT01902628|FG000|Participant Flow|Participants With CKD|This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
11154438|NCT01902628|OG000|Outcome|Participants With CKD|This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
11154439|NCT01902628|EG000|Reported Event|Participants With CKD|This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
11154440|NCT01902758|BG000|Baseline|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
11154441|NCT01902758|BG001|Baseline|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
11154442|NCT01902758|BG002|Baseline|Total|Total of all reporting groups
11154443|NCT01902758|FG000|Participant Flow|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
11154444|NCT01902758|FG001|Participant Flow|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
11154445|NCT01902758|OG000|Outcome|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
11154446|NCT01902758|OG001|Outcome|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
11154447|NCT01902758|EG000|Reported Event|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
11154448|NCT01902758|EG001|Reported Event|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
11154449|NCT01902901|BG000|Baseline|Usual Care|"Requested carrier status testing.~Carrier status testing: Carrier status testing"
11154450|NCT01902901|BG001|Baseline|Whole Genome Sequencing|"These participants will receive the carrier status testing they requested from their provider, plus whole genome sequencing.~Whole Genome Sequencing: Participants will receive Whole Genome Sequencing~Carrier status testing: Carrier status testing"
11154451|NCT01902901|BG002|Baseline|Total|Total of all reporting groups
11154452|NCT01902901|FG000|Participant Flow|Usual Care|"Requested carrier status testing.~Carrier status testing: Carrier status testing"
11154453|NCT01902901|FG001|Participant Flow|Whole Genome Sequencing|"These participants will receive the carrier status testing they requested from their provider, plus whole genome sequencing.~Whole Genome Sequencing: Participants will receive Whole Genome Sequencing~Carrier status testing: Carrier status testing"
11154454|NCT01902901|OG000|Outcome|Usual Care|"Requested carrier status testing.~Carrier status testing: Carrier status testing"
11154455|NCT01902901|OG001|Outcome|Whole Genome Sequencing|"These participants will receive the carrier status testing they requested from their provider, plus whole genome sequencing.~Whole Genome Sequencing: Participants will receive Whole Genome Sequencing~Carrier status testing: Carrier status testing"
11154456|NCT01902901|EG000|Reported Event|Usual Care|"Requested carrier status testing.~Carrier status testing: Carrier status testing"
11154457|NCT01902901|EG001|Reported Event|Whole Genome Sequencing|"These participants will receive the carrier status testing they requested from their provider, plus whole genome sequencing.~Whole Genome Sequencing: Participants will receive Whole Genome Sequencing~Carrier status testing: Carrier status testing"
11154458|NCT01902953|BG000|Baseline|Lymphoseek and VBD SLN Dissection|"Ex-Vivo Lymphoseek and VBD SLN dissection~Lymphoseek and VBD Sln dissection: See detailed description of study design"
11154459|NCT01902953|FG000|Participant Flow|Lymphoseek and VBD SLN Dissection|"Ex-Vivo Lymphoseek and VBD SLN dissection~Lymphoseek and VBD Sln dissection: See detailed description of study design"
11154460|NCT01902953|OG000|Outcome|Lymphoseek and VBD SLN Dissection|"Ex-Vivo Lymphoseek and VBD SLN dissection~Lymphoseek and VBD Sln dissection: See detailed description of study design"
11154461|NCT01902953|EG000|Reported Event|Lymphoseek and VBD SLN Dissection|"Ex-Vivo Lymphoseek and VBD SLN dissection~Lymphoseek and VBD Sln dissection: See detailed description of study design"
11154462|NCT01903005|BG000|Baseline|OX219-006 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
11154463|NCT01903005|BG001|Baseline|OX219-007 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
11154464|NCT01903005|BG002|Baseline|Total|Total of all reporting groups
11154465|NCT01903005|FG000|Participant Flow|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
11154466|NCT01903005|OG000|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
11154467|NCT01903005|OG000|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
11154468|NCT01903005|EG000|Reported Event|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
11154469|NCT01903031|BG000|Baseline|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
11228157|NCT02388386|OG001|Outcome|Cardiac Rhythm|Cardiac rhythm monitoring for arrhythmias
11154470|NCT01903031|BG001|Baseline|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
11154471|NCT01903031|BG002|Baseline|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
11154472|NCT01903031|BG003|Baseline|Total|Total of all reporting groups
11154473|NCT01903031|FG000|Participant Flow|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
11154474|NCT01903031|FG001|Participant Flow|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
11154475|NCT01903031|FG002|Participant Flow|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
11154476|NCT01903031|OG000|Outcome|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
11154477|NCT01903031|OG001|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
11154478|NCT01903031|OG002|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
11154479|NCT01903031|OG000|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
11154480|NCT01903031|OG000|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
11154481|NCT01903031|OG000|Outcome|NuvaRing With ATV/r Plus TDF ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
11154482|NCT01903031|EG000|Reported Event|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
11154483|NCT01903031|EG001|Reported Event|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
11154484|NCT01903031|EG002|Reported Event|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
11154485|NCT01903148|BG000|Baseline|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
11154486|NCT01903148|BG001|Baseline|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
11154487|NCT01903148|BG002|Baseline|Total|Total of all reporting groups
11154488|NCT01903148|FG000|Participant Flow|Patients With Anemia and CKD|Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
11154489|NCT01903148|OG000|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
11154490|NCT01903148|OG001|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
11154491|NCT01903148|EG000|Reported Event|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
11154492|NCT01903148|EG001|Reported Event|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
11154493|NCT01903187|BG000|Baseline|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
11154494|NCT01903187|BG001|Baseline|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
11154495|NCT01903187|BG002|Baseline|Total|Total of all reporting groups
11154496|NCT01903187|FG000|Participant Flow|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
11154497|NCT01903187|FG001|Participant Flow|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
11154498|NCT01903187|OG000|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
11154499|NCT01903187|OG001|Outcome|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
11154500|NCT01903187|OG001|Outcome|Sham|Renal artery angiogram without renal denervation
11154501|NCT01903187|EG000|Reported Event|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
11154502|NCT01903187|EG001|Reported Event|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram~Subjects exited after 1 month follow up"
11154503|NCT01903252|BG000|Baseline|TP05 (Mesalazine)|3.2 gram/day (g/d) once daily (OD) for 12 weeks (blinded),
11154504|NCT01903252|BG001|Baseline|Asacol (Mesalazine, Tillotts Pharma AG)|3.2g/d twice daily for 12 weeks (blinded),
11154505|NCT01903252|BG002|Baseline|Total|Total of all reporting groups
11154506|NCT01903252|FG000|Participant Flow|TP05 (Mesalazine) 1600 mg|3.2g/day once daily (OD) for 12 weeks (blinded),
11154507|NCT01903252|FG001|Participant Flow|Asacol (Mesalazine 400 mg)|3.2g/d twice daily for 12 weeks (blinded),
11154508|NCT01903252|FG002|Participant Flow|Extended Induction|Non-responders at week 8 of the induction phase were taken out of the double-blind phase and treated with TP05 4.8g/day OD for another 8 weeks
11154509|NCT01903252|FG003|Participant Flow|1.6g TP05 (1600 mg) /Day Maintenance Open-Label|Remitters at week 12 of the induction phase received a daily dose of 1.6g OD in the maintenance phase open-label.
11154510|NCT01903252|FG004|Participant Flow|3.2g TP05 (1600 mg) /Day Maintenance Open-Label|Responders at week 12 of the induction phase remained on a daily dose of 3.2 g OD in the maintenance phase open-label.
11154511|NCT01903252|FG005|Participant Flow|4.8g TP05 (1600 mg) /Day Maintenance Open-Label|Non-responders at week 12 of the double-blind induction phase as well as non-responders at week 8 of the induction phase who responded after a second 8 weeks of extended induction treatments, were enrolled into the maintenance phase and remained on a daily dose of 4.8g OD.
11154512|NCT01903252|OG000|Outcome|TP05 (Mesalazine)|3.2g/day once daily for 12 weeks (blinded),
11154513|NCT01903252|OG001|Outcome|Asacol (Mesalazine, Tillotts Pharma AG)|3.2g/d twice daily for 12 weeks (blinded),
11154514|NCT01903252|OG000|Outcome|Extended Induction|Non-responders to blinded treatment at week 8 of the induction phase (Period 1) were moved to open-label extended induction treatment of an additional 8 weeks (Period 2)
11154515|NCT01903252|OG000|Outcome|1.6g/Day Maintenance Open-Label|Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
11154516|NCT01903252|OG001|Outcome|3.2/Day Maintenance Open-Label|Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
11154517|NCT01903252|OG002|Outcome|4.8g/Day Maintenance Open-Label|Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
11154518|NCT01903252|OG000|Outcome|TP05 (Mesalazine)|3.2g/day once daily for 12 weeks (blinded)
11154519|NCT01903252|OG001|Outcome|Asacol (Mesalazine, Tillotts Pharma AG)|3.2g/d twice daily for 12 weeks (blinded)
11154520|NCT01903252|OG000|Outcome|TP05 (Mesalazine)|3.2g/day once daily at week 8
11228158|NCT02388386|OG002|Outcome|LVAD Device Interrogation|Change in LVAD device parameters
11154521|NCT01903252|OG001|Outcome|Asacol (Mesalazine)|3.2g/d twice daily at week 8
11154522|NCT01903252|OG000|Outcome|1.6g/Day Maintenance Open-Label|Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase (Period 3)
11154523|NCT01903252|EG000|Reported Event|TP05/TP05|Double-blind Induction Phase: TP05, and Open-Label Maintenance Phase: TP05
11154524|NCT01903252|EG001|Reported Event|Asacol/TP05|Double-blind Induction Phase: Asacol, and Open-Label Maintenance Phase: TP05
11154525|NCT01903252|EG002|Reported Event|TP05 Extended Induction|Extended Induction only, Open-Label
11154526|NCT01903252|EG003|Reported Event|TP05|Double-blind Induction Phase only
11154527|NCT01903252|EG004|Reported Event|Asacol|Double-blind Induction Phase only
11154528|NCT01903265|BG000|Baseline|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
11154529|NCT01903265|BG001|Baseline|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. (One patient randomized in error never received study drug and therefore is not included in this table.)"
11154530|NCT01903265|BG002|Baseline|Total|Total of all reporting groups
11154531|NCT01903265|FG000|Participant Flow|TNX-102 SL 2.8 mg|1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks
11154532|NCT01903265|FG001|Participant Flow|Placebo|1 tablet of placebo sublingually each day at bedtime for 12 weeks.
11154533|NCT01903265|OG000|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
11154534|NCT01903265|OG001|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
11154535|NCT01903265|EG000|Reported Event|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
11154536|NCT01903265|EG001|Reported Event|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
11154537|NCT01903356|BG000|Baseline|TrajentaDuo® Tablet|Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
11154538|NCT01903356|FG000|Participant Flow|TrajentaDuo® Tablet|Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
11154539|NCT01903356|OG000|Outcome|TrajentaDuo® Tablet|Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
11154540|NCT01903356|EG000|Reported Event|TrajentaDuo® Tablet|Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
11154541|NCT01903434|BG000|Baseline|130 mg Evacetrapib|Participants randomized to receive a single dose of 130 mg evacetrapib of either of the two different solid fraction controls on Day 1 of each of 3 treatment periods, according to their assigned treatment sequence.
11154542|NCT01903434|FG000|Participant Flow|Reference/Test/Test|"A single dose of Reference 130 mg evacetrapib on Day 1 of Period 1 and of Test 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3.~There was a washout period of at least 14 days between doses. Each participant received up to 3 doses."
11228159|NCT02388386|OG003|Outcome|Implantable Cardioverter Defibrillator Interrogation|Assessment of cardiac arrhythmias by ICD interrogation
11154543|NCT01903434|FG001|Participant Flow|Test/Reference/Reference|"A single dose of Test 130 mg evacetrapib on Day 1 of Period 1 and of Reference 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3.~There was a washout period of at least 14 days between doses. Each participant received up to 3 doses."
11154544|NCT01903434|OG000|Outcome|Reference|Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods.
11154545|NCT01903434|OG001|Outcome|Test|Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
11154546|NCT01903434|EG000|Reported Event|Reference|Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods.
11154547|NCT01903434|EG001|Reported Event|Test|Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
11154548|NCT01903460|BG000|Baseline|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
11154549|NCT01903460|BG001|Baseline|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
11154550|NCT01903460|BG002|Baseline|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
11154551|NCT01903460|BG003|Baseline|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
11154552|NCT01903460|BG004|Baseline|Total|Total of all reporting groups
11154553|NCT01903460|FG000|Participant Flow|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
11154554|NCT01903460|FG001|Participant Flow|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
11154555|NCT01903460|FG002|Participant Flow|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
11154556|NCT01903460|FG003|Participant Flow|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
11154557|NCT01903460|OG000|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
11154558|NCT01903460|OG001|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
11154559|NCT01903460|OG002|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
11154560|NCT01903460|OG003|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
11154561|NCT01903460|EG000|Reported Event|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
11154562|NCT01903460|EG001|Reported Event|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
11154563|NCT01903460|EG002|Reported Event|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
11154564|NCT01903525|BG000|Baseline|Placebo|"The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the placebo for 12 weeks.~Placebo: Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks."
11173832|NCT02018107|OG000|Outcome|N-13 Ammonia or F-18 to Image Liver PET Perfusion|"This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only~N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer~PET scan: PET scan"
11228160|NCT02388386|EG000|Reported Event|PROTEUS-SENSOR|10 consecutive heart failure patients with continuous flow left ventricular devices
11228161|NCT02388568|BG000|Baseline|Lorcaserin Plus Lifestyle Modification|Lorcaserin: Lorcaserin plus Lifestyle Modification
11154565|NCT01903525|BG001|Baseline|Docosahexaenoic Acid (DHA)|"The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the DHA for 12 weeks.~Docosahexaenoic acid (DHA): Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks."
11154566|NCT01903525|BG002|Baseline|Total|Total of all reporting groups
11154567|NCT01903525|FG000|Participant Flow|Placebo|"The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the placebo for 12 weeks.~Docosahexaenoic acid (DHA): Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks."
11154568|NCT01903525|FG001|Participant Flow|Docosahexaenoic Acid (DHA)|"The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the DHA for 12 weeks.~Docosahexaenoic acid (DHA): Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks."
11154569|NCT01903525|OG000|Outcome|Placebo|"The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the placebo for 12 weeks.~Placebo: Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks."
11154570|NCT01903525|OG001|Outcome|Docosahexaenoic Acid (DHA)|"The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the DHA for 12 weeks.~Docosahexaenoic acid (DHA): Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks."
11173833|NCT02018107|EG000|Reported Event|N-13 Ammonia to Image Liver PET Perfusion|"This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only~N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer~PET scan: PET scan"
11173834|NCT02018315|BG000|Baseline|Experimental: Triheptanoin|Triheptanoin (C7 oil, liquid) dosed at 1 g/kg body weight divided and administered 4 times per day via mouth or g-tube for 3 months.
11154571|NCT01903525|EG000|Reported Event|Placebo|"The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the placebo for 12 weeks.~Docosahexaenoic acid (DHA): Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks."
11154572|NCT01903525|EG001|Reported Event|Docosahexaenoic Acid (DHA)|"The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the DHA for 12 weeks.~Docosahexaenoic acid (DHA): Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks."
11154573|NCT01903564|BG000|Baseline|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
11154574|NCT01903564|BG001|Baseline|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
11154575|NCT01903564|BG002|Baseline|Total|Total of all reporting groups
11154576|NCT01903564|FG000|Participant Flow|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
11154577|NCT01903564|FG001|Participant Flow|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
11154578|NCT01903564|OG000|Outcome|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
11154579|NCT01903564|OG001|Outcome|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
11154580|NCT01903564|EG000|Reported Event|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
11154581|NCT01903564|EG001|Reported Event|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
11154582|NCT01903720|BG000|Baseline|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
11154583|NCT01903720|FG000|Participant Flow|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
11154584|NCT01903720|OG000|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
11154585|NCT01903720|EG000|Reported Event|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
11154586|NCT01903733|BG000|Baseline|Bosutinib, CP1L|Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).
11154587|NCT01903733|BG001|Baseline|Bosutinib, CP2L|Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.
11154588|NCT01903733|BG002|Baseline|Bosutinib, CP3L/CP4L|Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.
11154589|NCT01903733|BG003|Baseline|Bosutinib, ADV|Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.
11154590|NCT01903733|BG004|Baseline|Total|Total of all reporting groups
11173835|NCT02018315|FG000|Participant Flow|Experimental: Triheptanoin|Triheptanoin (C7 oil, liquid) dosed at 1 g/kg body weight divided and administered 4 times per day via mouth or g-tube for 3 months.
11228162|NCT02388568|BG001|Baseline|Placebo Plus Lifestyle Modification|Placebo: Placebo plus Lifestyle Modification
11154591|NCT01903733|FG000|Participant Flow|Bosutinib, CP1L|Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML) who either continued to receive the same bosutinib dose as at the time of completion of B1871008 or continued to be followed for survival. Dose for bosutinib was 500 milligram (mg) orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.
11154592|NCT01903733|FG001|Participant Flow|Bosutinib, CP2L|Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib either continued to receive the same bosutinib dose as at the time of completion of B1871006 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.
11154593|NCT01903733|FG002|Participant Flow|Bosutinib, CP3L/CP4L|Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib either continued to receive the same bosutinib dose as at the time of completion of B1871006 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.
11154594|NCT01903733|FG003|Participant Flow|Bosutinib, ADV|Advanced (ADV) participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML, Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant or intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib who either continued to receive the same bosutinib dose as at the time of completion of B1871008 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.
11154595|NCT01903733|OG000|Outcome|Bosutinib, CP1L|Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).
11154596|NCT01903733|OG001|Outcome|Bosutinib, CP2L|Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.
11154597|NCT01903733|OG002|Outcome|Bosutinib, CP3L/CP4L|Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.
11154598|NCT01903733|OG003|Outcome|Bosutinib, ADV|Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.
11154599|NCT01903733|OG004|Outcome|Bosutinib, Total|Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.
11154600|NCT01903733|OG000|Outcome|Bosutinib 200 mg|Participants received uninterrupted once daily oral 200 mg dose of bosutinib for at least 2 weeks in study B1871040.
11154601|NCT01903733|OG001|Outcome|Bosutinib 300 mg|Participants received uninterrupted once daily oral 300 mg dose of bosutinib for at least 2 weeks in study B1871040.
11154602|NCT01903733|OG002|Outcome|Bosutinib 400 mg|Participants received uninterrupted once daily oral 400 mg dose of bosutinib for at least 2 weeks in study B1871040.
11154603|NCT01903733|OG003|Outcome|Bosutinib 500 mg|Participants received uninterrupted once daily oral 500 mg dose of bosutinib for at least 2 weeks in study B1871040.
11154604|NCT01903733|OG004|Outcome|Bosutinib 600 mg|Participants received uninterrupted once daily oral 600 mg dose of bosutinib for at least 2 weeks in study B1871040.
11154605|NCT01903733|OG000|Outcome|Bosutinib, CP2L|Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.
11154606|NCT01903733|OG001|Outcome|Bosutinib, CP3L/CP4L|Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.
11154607|NCT01903733|OG002|Outcome|Bosutinib, ADV|Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.
11154608|NCT01903733|EG000|Reported Event|Bosutinib, CP1L|Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).
11154609|NCT01903733|EG001|Reported Event|Bosutinib, CP2L|Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.
11154610|NCT01903733|EG002|Reported Event|Bosutinib, CP3L/CP4L|Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.
11154611|NCT01903733|EG003|Reported Event|Bosutinib, ADV|Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.
11154612|NCT01903733|EG004|Reported Event|Bosutinib, Total|Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.
11154613|NCT01903798|BG000|Baseline|Continue Prednisolone (Lille <0.45)|"Continue prednisolone 40 mg/day (current standard of care) for 21 days.~Prednisolone: Corticosteroid"
11154614|NCT01903798|BG001|Baseline|Rilonacept + Prednisolone (Lille <0.45)|"Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).~Rilonacept: Interleukin-1 blocker~Prednisolone: Corticosteroid"
11154615|NCT01903798|BG002|Baseline|Standard of Care (Lille ≥ 0.45)|Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)
11154616|NCT01903798|BG003|Baseline|Mycophenolate + Prednisolone (Lille ≥ 0.45)|"Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).~Mycophenolate mofetil: Immunosuppressive agent~Prednisolone: Corticosteroid"
11154617|NCT01903798|BG004|Baseline|Total|Total of all reporting groups
11154618|NCT01903798|FG000|Participant Flow|Continue Prednisolone (Lille <0.45)|"Continue prednisolone 40 mg/day (current standard of care) for 21 days.~Prednisolone: Corticosteroid"
11154619|NCT01903798|FG001|Participant Flow|Rilonacept + Prednisolone (Lille <0.45)|"Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).~Rilonacept: Interleukin-1 blocker~Prednisolone: Corticosteroid"
11154620|NCT01903798|FG002|Participant Flow|Standard of Care (Lille ≥ 0.45)|Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)
11154621|NCT01903798|FG003|Participant Flow|Mycophenolate + Prednisolone (Lille ≥ 0.45)|"Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).~Mycophenolate mofetil: Immunosuppressive agent~Prednisolone: Corticosteroid"
11154622|NCT01903798|OG000|Outcome|Continue Prednisolone (Lille <0.45)|"Continue prednisolone 40 mg/day (current standard of care) for 21 days.~Prednisolone: Corticosteroid"
11154623|NCT01903798|OG001|Outcome|Rilonacept + Prednisolone (Lille <0.45)|"Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).~Rilonacept: Interleukin-1 blocker~Prednisolone: Corticosteroid"
11154624|NCT01903798|OG002|Outcome|Standard of Care (Lille ≥ 0.45)|Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)
11154625|NCT01903798|OG003|Outcome|Mycophenolate + Prednisolone (Lille ≥ 0.45)|"Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).~Mycophenolate mofetil: Immunosuppressive agent~Prednisolone: Corticosteroid"
11154626|NCT01903798|EG000|Reported Event|Continue Prednisolone (Lille <0.45)|"Continue prednisolone 40 mg/day (current standard of care) for 21 days.~Prednisolone: Corticosteroid"
11154627|NCT01903798|EG001|Reported Event|Rilonacept + Prednisolone (Lille <0.45)|"Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).~Rilonacept: Interleukin-1 blocker~Prednisolone: Corticosteroid"
11154628|NCT01903798|EG002|Reported Event|Standard of Care (Lille ≥ 0.45)|Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)
11154629|NCT01903798|EG003|Reported Event|Mycophenolate + Prednisolone (Lille ≥ 0.45)|"Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).~Mycophenolate mofetil: Immunosuppressive agent~Prednisolone: Corticosteroid"
11154630|NCT01903811|BG000|Baseline|Arm I (Dexamethasone, Low-dose Carfilzomib)|"Patients receive dexamethasone IV and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II.~Carfilzomib: Given IV~Dexamethasone: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11154631|NCT01903811|BG001|Baseline|Arm II (Dexamethasone, High-dose Carfilzomib)|"Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV~Dexamethasone: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11154632|NCT01903811|BG002|Baseline|Total|Total of all reporting groups
11154633|NCT01903811|FG000|Participant Flow|Arm I (Dexamethasone, Low-dose Carfilzomib)|"Patients receive dexamethasone IV and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II.~Carfilzomib: Given IV~Dexamethasone: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11154634|NCT01903811|FG001|Participant Flow|Arm II (Dexamethasone, High-dose Carfilzomib)|"Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV~Dexamethasone: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11154635|NCT01903811|OG000|Outcome|Arm I (Dexamethasone, Low-dose Carfilzomib)|"Patients receive 20 mg dexamethasone IV and low-dose (27 mg/m^2) carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose of 20 mg/m^2.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II.~Carfilzomib: Given IV~Dexamethasone: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11154636|NCT01903811|OG001|Outcome|Arm II (Dexamethasone, High-dose Carfilzomib)|"Patients receive 20 mg dexamethasone IV and high-dose (56 mg/m^2) carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose of 20 mg/m^2 over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV~Dexamethasone: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11154637|NCT01903811|OG000|Outcome|Arm III (Crossover Group)|"Patients on Arm 1 that progress after the start of course 2 and prior to completion of 12 courses receive 20 mg dexamethasone IV and high-dose (56 mg/m^2) carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 additional courses in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies"
11154638|NCT01903811|OG000|Outcome|Crossover Arm|"Patients on Arm 1 that progress after the start of course 2 and prior to completion of 12 courses receive 20 mg dexamethasone IV and high-dose (56 mg/m^2) carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 additional courses in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies"
11154639|NCT01903811|EG000|Reported Event|Arm I (Dexamethasone, Low-dose Carfilzomib)|Patients receive dexamethasone and low dose carfilzomib. Includes all eligible and analyzable patients. Deaths for patients that registered Crossover arm are also counted in this arm.
11154640|NCT01903811|EG001|Reported Event|Arm II (Dexamethasone, High-dose Carfilzomib)|Patients receive dexamethasone and high dose carfilzomib. Includes all eligible and analyzable patients.
11154641|NCT01903811|EG002|Reported Event|Crossover Arm|"Patients on Arm 1 that progress after the start of cycle 2 and prior to completion of 12 cycles receive high dose carfilzomib. Includes all eligible and analyzable patients. These patients are also included under Arm I."
11154642|NCT01903837|BG000|Baseline|Olz + Placebo|Olanzapine (dose level determined by Investigator) and placebo tablets taken once daily
11154643|NCT01903837|BG001|Baseline|Olz + Sam 5mg|Olanzapine (dose level determined by Investigator) and 5mg Samidorphan tablets taken once daily
11154644|NCT01903837|BG002|Baseline|Olz + Sam 10mg|Olanzapine (dose level determined by Investigator) and 10mg Samidorphan tablets taken once daily
11154645|NCT01903837|BG003|Baseline|Olz + Sam 20mg|Olanzapine (dose level determined by Investigator) and 20mg Samidorphan tablets taken once daily
11154646|NCT01903837|BG004|Baseline|Total|Total of all reporting groups
11154647|NCT01903837|FG000|Participant Flow|Olz + Placebo/ Olz+Sam 20mg|"Part A: Olanzapine (dose level determined by Investigator) + placebo tablets taken once daily~Part B: Olanzapine (dose level determined by Investigator) + 20mg Samidorphan tablets taken once daily~Subjects were transitioned from placebo in Part A to 20mg Samidorphan in Part B"
11154648|NCT01903837|FG001|Participant Flow|Olz + Sam 5mg / Olz + Sam 5mg|"Part A: Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily~Part B: Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily"
11154649|NCT01903837|FG002|Participant Flow|Olz + Sam 10mg /Olz + Sam 10mg|"Part A: Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily~Part B: Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily"
11154650|NCT01903837|FG003|Participant Flow|Olz + Sam 20mg/ Olz + Sam 20mg|"Part A: Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily~Part B: Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily"
11154651|NCT01903837|OG000|Outcome|Part A FAS 1 - Olz + Placebo|Subjects who were randomized to olanzapine + placebo in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154652|NCT01903837|OG001|Outcome|Part A FAS 1 - Olz + Sam 5mg|Subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154653|NCT01903837|OG002|Outcome|Part A FAS 1- Olz+ Sam 10mg|Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154654|NCT01903837|OG003|Outcome|Part A FAS 1- Olz+ Sam 20mg|Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154655|NCT01903837|OG002|Outcome|Part A FAS 1- Olz + Sam 10mg|Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154656|NCT01903837|OG003|Outcome|Part A FAS 1- Olz + Sam 20mg|Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154657|NCT01903837|OG004|Outcome|Part A FAS 2- Olz + Placebo|All FAS 1 subjects who were randomized to olanzapine + placebo in study Part A, gained weight during the first week of olanzapine treatment prior to randomization, and had at least one post-baseline weight assessment.
11154658|NCT01903837|OG005|Outcome|Part A FAS 2- Olz + Sam 5mg|All FAS 1 subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization, and had at least one post-baseline weight assessment.
11154659|NCT01903837|OG006|Outcome|Part A FAS 2- Olz + Sam 10mg|All FAS 1 subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization, and had at least one post-baseline weight assessment.
11154660|NCT01903837|OG007|Outcome|Part A FAS 2- Olz + 20mg|All FAS 1 subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization, and had at least one post-baseline weight assessment.
11228163|NCT02388568|BG002|Baseline|Total|Total of all reporting groups
11154661|NCT01903837|OG000|Outcome|Part A FAS 1- Olz + Placebo|Subjects who were randomized to olanzapine + placebo in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154662|NCT01903837|OG001|Outcome|Part A FAS 1- Olz + Sam 5mg|Subjects who were randomized to olanzapine + 5mg samidorphan in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154663|NCT01903837|OG002|Outcome|Part A FAS 1- Olz + Sam 10mg|Subjects who were randomized to olanzapine + 10mg samidorphan in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154664|NCT01903837|OG003|Outcome|Part A FAS 1- Olz + Sam 20mg|Subjects who were randomized to olanzapine + 20mg samidorphan in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154665|NCT01903837|OG007|Outcome|Part A FAS 2- Olz + Sam 20mg|All FAS 1 subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization, and had at least one post-baseline weight assessment.
11154666|NCT01903837|OG001|Outcome|Part A FAS 1- Olz + Sam 5mg|Subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154667|NCT01903837|OG004|Outcome|Part A FAS 2- Olz + Placebo|All FAS 1 subjects who were randomized to olanzapine + placebo in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.
11154668|NCT01903837|OG005|Outcome|Part A FAS 2- Olz + Sam 5mg|All FAS 1 subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.
11154669|NCT01903837|OG006|Outcome|Part A FAS 2- Olz + Sam 10mg|Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154670|NCT01903837|OG007|Outcome|Part A FAS 2- Olz + Sam 20mg|Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154671|NCT01903837|OG000|Outcome|Part A FAS 1 - OLZ + Placebo|Subjects who were randomized to olanzapine + placebo in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
11154672|NCT01903837|EG000|Reported Event|Part A- Olz + Placebo|Olanzapine (dose level determined by Investigator) + placebo tablets taken once daily
11154673|NCT01903837|EG001|Reported Event|Part A-Olz + Sam 5mg|Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily
11154674|NCT01903837|EG002|Reported Event|Part A- Olz + Sam 10mg|Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily
11154675|NCT01903837|EG003|Reported Event|Part A- Olz + Sam 20mg|Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily
11154676|NCT01903837|EG004|Reported Event|Part B-Olz +Placebo/ Olz+Sam 20mg|"Olanzapine (dose level determined by Investigator) + 20mg Samidorphan tablets taken once daily~Subjects were transitioned from placebo in Part A to 20mg Samidorphan in Part B"
11154677|NCT01903837|EG005|Reported Event|Part B- Olz + Sam 5mg / Olz +Sam 5mg|Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily
11154678|NCT01903837|EG006|Reported Event|Part B- Olz + Sam 10mg/ Olz + Sam 10mg|Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily
11154679|NCT01903837|EG007|Reported Event|Part B-Olz + Sam 20mg/ Olz + Sam 20mg|Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily
11154680|NCT01903863|BG000|Baseline|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
11154681|NCT01903863|BG001|Baseline|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
11154682|NCT01903863|BG002|Baseline|Total|Total of all reporting groups
11154683|NCT01903863|FG000|Participant Flow|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
11154684|NCT01903863|FG001|Participant Flow|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
11173836|NCT02018315|OG000|Outcome|Experimental: Triheptanoin|Triheptanoin (C7 oil, liquid) dosed at 1 g/kg body weight divided and administered 4 times per day via mouth or g-tube for 3 months.
11154685|NCT01903863|OG000|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
11154686|NCT01903863|OG001|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
11154687|NCT01903863|EG000|Reported Event|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
11154688|NCT01903863|EG001|Reported Event|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
11154689|NCT01903876|BG000|Baseline|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
11154690|NCT01903876|BG001|Baseline|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
11154691|NCT01903876|BG002|Baseline|Total|Total of all reporting groups
11154692|NCT01903876|FG000|Participant Flow|General Health Promotion|A 3-hour general mental health web-based program.
11154693|NCT01903876|FG001|Participant Flow|Bystander & Sexual Violence Prevention|A 3-hour web-based program designed to teach male college student bystanders to intervene.
11154694|NCT01903876|OG000|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
11154695|NCT01903876|OG001|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
11154696|NCT01903876|EG000|Reported Event|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
11154697|NCT01903876|EG001|Reported Event|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
11154698|NCT01903993|BG000|Baseline|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
11154699|NCT01903993|BG001|Baseline|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
11154700|NCT01903993|BG002|Baseline|Total|Total of all reporting groups
11154701|NCT01903993|FG000|Participant Flow|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
11154702|NCT01903993|FG001|Participant Flow|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
11154703|NCT01903993|OG000|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
11154704|NCT01903993|OG001|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
11154705|NCT01903993|OG000|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
11154706|NCT01903993|EG000|Reported Event|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
11154707|NCT01903993|EG001|Reported Event|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
11154708|NCT01904019|BG000|Baseline|ARPE Prosthesis|Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
11154709|NCT01904019|FG000|Participant Flow|ARPE Prosthesis|Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
11154710|NCT01904019|OG000|Outcome|ARPE Prosthesis|Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
11154711|NCT01904019|EG000|Reported Event|ARPE Prosthesis|Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
11154712|NCT01904058|BG000|Baseline|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154713|NCT01904058|BG001|Baseline|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154714|NCT01904058|BG002|Baseline|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154715|NCT01904058|BG003|Baseline|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154716|NCT01904058|BG004|Baseline|Total|Total of all reporting groups
11154717|NCT01904058|FG000|Participant Flow|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154718|NCT01904058|FG001|Participant Flow|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154719|NCT01904058|FG002|Participant Flow|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154720|NCT01904058|FG003|Participant Flow|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154721|NCT01904058|OG000|Outcome|LUM001 10 mg + UDCA (Cohort A|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154722|NCT01904058|OG001|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154723|NCT01904058|OG002|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154724|NCT01904058|OG003|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11173837|NCT02018315|EG000|Reported Event|Triheptanoin|"Triheptanoin (C7 oil, liquid) dosed at 1 g/kg body weight divided and administered 4 times per day via mouth or g-tube for 3 months.~Triheptanoin: Triheptanoin is a 7-carbon medium chain triglyceride"
11154725|NCT01904058|OG000|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154726|NCT01904058|OG003|Outcome|Placebo + UDCA (Cohort B|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
11154727|NCT01904058|OG000|Outcome|LUM001 5 mg + UDCA|Participants received LUM001 5 milligram (mg) tablet orally once daily for a period of 13 weeks in combination with UDCA.
11154728|NCT01904058|OG001|Outcome|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
11154729|NCT01904058|OG002|Outcome|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
11154730|NCT01904058|OG003|Outcome|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
11154731|NCT01904058|EG000|Reported Event|LUM001 5 mg + UDCA|Participants received LUM001 5 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
11154732|NCT01904058|EG001|Reported Event|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
11154733|NCT01904058|EG002|Reported Event|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
11154734|NCT01904058|EG003|Reported Event|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
11154735|NCT01904071|BG000|Baseline|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
11154736|NCT01904071|BG001|Baseline|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
11154737|NCT01904071|BG002|Baseline|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
11154738|NCT01904071|BG003|Baseline|Total|Total of all reporting groups
11154739|NCT01904071|FG000|Participant Flow|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
11154740|NCT01904071|FG001|Participant Flow|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
11154741|NCT01904071|FG002|Participant Flow|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
11154742|NCT01904071|OG000|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
11154743|NCT01904071|OG001|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
11154744|NCT01904071|OG002|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
11154745|NCT01904071|EG000|Reported Event|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
11154746|NCT01904071|EG001|Reported Event|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
11154747|NCT01904071|EG002|Reported Event|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
11154748|NCT01904149|BG000|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
11154749|NCT01904149|BG001|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
11154750|NCT01904149|BG002|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
11173838|NCT02018445|BG000|Baseline|All Patients|
11154751|NCT01904149|BG003|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
11154752|NCT01904149|BG004|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
11154753|NCT01904149|BG005|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
11154754|NCT01904149|BG006|Baseline|Total|Total of all reporting groups
11154755|NCT01904149|FG000|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
11154756|NCT01904149|FG001|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
11154757|NCT01904149|FG002|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
11154758|NCT01904149|FG003|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
11154759|NCT01904149|FG004|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
11154760|NCT01904149|FG005|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
11154761|NCT01904149|OG000|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
11154762|NCT01904149|OG001|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
11154763|NCT01904149|OG002|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
11154764|NCT01904149|OG003|Outcome|PLACEBO|Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
11154765|NCT01904149|OG003|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours); Drug: Placebo single oral dose (first 8 hours) Arm type: placebo comparator; placebo single oral dose (first 8 hours)
11154766|NCT01904149|OG000|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
11154767|NCT01904149|OG001|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
11154768|NCT01904149|OG002|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
11154769|NCT01904149|EG000|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
11154770|NCT01904149|EG001|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
11154771|NCT01904149|EG002|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
11154772|NCT01904149|EG003|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
11154773|NCT01904149|EG004|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
11154774|NCT01904149|EG005|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
11154775|NCT01904383|BG000|Baseline|Trazenta®|Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
11154776|NCT01904383|FG000|Participant Flow|Trazenta®|Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
11154777|NCT01904383|OG000|Outcome|Trazenta®|Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
11154778|NCT01904383|EG000|Reported Event|Trazenta®|Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration.
11154779|NCT01904448|BG000|Baseline|Pediatric ABI|Single-arm study of Auditory Brainstem Implantation (ABI) in children
11154780|NCT01904448|FG000|Participant Flow|Pediatric Auditory Brainstem Implantation (ABI)|Single-arm study of Auditory Brainstem Implantation (ABI) in children
11154781|NCT01904448|OG000|Outcome|Pediatric ABI|Single-arm study of Auditory Brainstem Implantation (ABI) in children
11154782|NCT01904448|OG000|Outcome|Pediatric ABI|Single-Arm Study of Auditory Brainstem Implantation (ABI) in Children
11154783|NCT01904448|EG000|Reported Event|Pediatric ABI|Single-arm study of Auditory Brainstem Implantation (ABI) in children
11154784|NCT01904526|BG000|Baseline|Guanfacine|Guanfacine: 3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
11154785|NCT01904526|FG000|Participant Flow|Guanfacine|Guanfacine: 3mg/day immediate release (IR) with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day extended release (ER). Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
11154786|NCT01904526|OG000|Outcome|Guanfacine 3mg/Day Immediate Release|Guanfacine: 3mg/day immediate release
11154787|NCT01904526|OG001|Outcome|Guanfacine 4mg/Day Extended Release|Guanfacine: 4mg/day extended release
11154788|NCT01904526|OG002|Outcome|Guanfacine 6mg/Day Extended Release|Guanfacine: 6mg/day extended release
11154789|NCT01904526|EG000|Reported Event|Guanfacine 3mg/Day Immediate Release|Guanfacine: 3mg/day immediate release
11154790|NCT01904526|EG001|Reported Event|Guanfacine 4mg/Day Extended Release|Guanfacine: 4mg/day extended release
11154791|NCT01904526|EG002|Reported Event|Guanfacine 6mg/Day Extended Release|Guanfacine: 6mg/day extended release
11228164|NCT02388568|FG000|Participant Flow|Lorcaserin Plus Lifestyle Modification|Lorcaserin: Lorcaserin plus Lifestyle Modification
11228165|NCT02388568|FG001|Participant Flow|Placebo Plus Lifestyle Modification|Placebo: Placebo plus Lifestyle Modification
11154792|NCT01904604|BG000|Baseline|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
11154793|NCT01904604|BG001|Baseline|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154794|NCT01904604|BG002|Baseline|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154795|NCT01904604|BG003|Baseline|Total|Total of all reporting groups
11154796|NCT01904604|FG000|Participant Flow|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
11154797|NCT01904604|FG001|Participant Flow|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154798|NCT01904604|FG002|Participant Flow|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154799|NCT01904604|OG000|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
11154800|NCT01904604|OG001|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11228166|NCT02388568|OG000|Outcome|Lorcaserin Plus Lifestyle Modification|Lorcaserin: Lorcaserin plus Lifestyle Modification
10887709|NCT00502593|BG008|Baseline|GSK1562902A-C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11154801|NCT01904604|OG002|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154802|NCT01904604|OG000|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154803|NCT01904604|OG001|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154804|NCT01904604|EG000|Reported Event|Placebo Patch Before Week 52 OFC (Double Blind)|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
11154805|NCT01904604|EG001|Reported Event|Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label)|"After 52 weeks of double-blind Placebo Patch therapy, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154806|NCT01904604|EG002|Reported Event|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154807|NCT01904604|EG003|Reported Event|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
11154808|NCT01904721|BG000|Baseline|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
11154809|NCT01904721|BG001|Baseline|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
11154810|NCT01904721|BG002|Baseline|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
11154811|NCT01904721|BG003|Baseline|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
11154812|NCT01904721|BG004|Baseline|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154813|NCT01904721|BG005|Baseline|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154814|NCT01904721|BG006|Baseline|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154815|NCT01904721|BG007|Baseline|Total|Total of all reporting groups
11228167|NCT02388568|OG001|Outcome|Placebo Plus Lifestyle Modification|Placebo: Placebo plus Lifestyle Modification
11154816|NCT01904721|FG000|Participant Flow|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
11154817|NCT01904721|FG001|Participant Flow|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
11154818|NCT01904721|FG002|Participant Flow|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
11154819|NCT01904721|FG003|Participant Flow|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
11154820|NCT01904721|FG004|Participant Flow|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154821|NCT01904721|FG005|Participant Flow|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154822|NCT01904721|FG006|Participant Flow|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154823|NCT01904721|OG000|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154824|NCT01904721|OG001|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154825|NCT01904721|OG002|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154826|NCT01904721|EG000|Reported Event|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
11154827|NCT01904721|EG001|Reported Event|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
11154828|NCT01904721|EG002|Reported Event|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
11154829|NCT01904721|EG003|Reported Event|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
11154830|NCT01904721|EG004|Reported Event|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
10887710|NCT00502593|BG009|Baseline|Fluarix-C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11154831|NCT01904721|EG005|Reported Event|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154832|NCT01904721|EG006|Reported Event|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
11154833|NCT01904760|BG000|Baseline|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
11154834|NCT01904760|BG001|Baseline|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
11154835|NCT01904760|BG002|Baseline|Total|Total of all reporting groups
11154836|NCT01904760|FG000|Participant Flow|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
11154837|NCT01904760|FG001|Participant Flow|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
11154838|NCT01904760|OG000|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
11154839|NCT01904760|OG001|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
11154840|NCT01904760|EG000|Reported Event|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
11154841|NCT01904760|EG001|Reported Event|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
11154842|NCT01904773|BG000|Baseline|Overall Study|Part 1 & Part 2
11154843|NCT01904773|FG000|Participant Flow|Initial Study|Initial Screen, Part 1: AZD5213 0.5 mg single dose Day 1, AZD5213 2 mg dose Days 6-8
11154844|NCT01904773|FG001|Participant Flow|Part 2 -Sequence BBABBA|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
11154845|NCT01904773|FG002|Participant Flow|Part 2- Sequence BABBAB|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
11154846|NCT01904773|FG003|Participant Flow|Part 2 - Sequence ABCACB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
11154847|NCT01904773|FG004|Participant Flow|Part 2- Sequence ACBABC|A= Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
11154848|NCT01904773|FG005|Participant Flow|Part 2- Sequence BACCAB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
11154849|NCT01904773|FG006|Participant Flow|Part 2- Sequence BCACBA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
11154850|NCT01904773|FG007|Participant Flow|Part 2 Sequence CABBAC|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
11154851|NCT01904773|FG008|Participant Flow|Part 2- Seqence CBABCA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
11154852|NCT01904773|OG000|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
11154853|NCT01904773|OG001|Outcome|AZD5213 2.0 mg|Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
11154854|NCT01904773|OG002|Outcome|Placebo|Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
11154855|NCT01904773|EG000|Reported Event|Overall Study|Part 1 & Part 2
11154856|NCT01904773|EG001|Reported Event|Part 1 - AZD5213 0.5 mg|Part 1 - Day 1, AZD5213 0.5 mg
11154857|NCT01904773|EG002|Reported Event|Part 1 - AZD5213 2.0 mg|Part 1 - Days 6-8, AZD5213 2.0 mg
11154858|NCT01904773|EG003|Reported Event|Part 2 - AZD5213 0.5 mg|Part 2 - AZD5213, 0.5 mg periods (2-4 periods)
11154859|NCT01904773|EG004|Reported Event|Part 2 - AZD5213 2.0 mg|Part 2 - AZD5213, 2.0 mg periods (2 periods)
11154860|NCT01904773|EG005|Reported Event|Part 2 - Placebo|Part 2 - Placebo periods (2 periods)
11154861|NCT01904773|EG006|Reported Event|Part 1 - Placebo|Part 1 - Placebo, Days 2-5, washout after 0.5 mg single dose
11154862|NCT01904864|BG000|Baseline|NovaFerrum® (Iron Polysaccharide Complex)|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.
11154863|NCT01904864|BG001|Baseline|Ferrous Sulfate|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
11154864|NCT01904864|BG002|Baseline|Total|Total of all reporting groups
11154865|NCT01904864|FG000|Participant Flow|NovaFerrum® (Iron Polysaccharide Complex)|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.
11154866|NCT01904864|FG001|Participant Flow|Ferrous Sulfate|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
11154867|NCT01904864|OG000|Outcome|NovaFerrum® (Iron Polysaccharide Complex)|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.
11154868|NCT01904864|OG001|Outcome|Ferrous Sulfate|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
11154869|NCT01904864|EG000|Reported Event|NovaFerrum® (Iron Polysaccharide Complex)|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.
11154870|NCT01904864|EG001|Reported Event|Ferrous Sulfate|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
11154871|NCT01905241|BG000|Baseline|Anatomic TSA Using RTI|"During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.~Anatomic TSA using RTI: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant."
11154872|NCT01905241|FG000|Participant Flow|Anatomic TSA Using RTI|"During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.~Anatomic TSA using RTI: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant."
11154873|NCT01905241|OG000|Outcome|Anatomic TSA Using RTI|"During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.~Anatomic TSA using RTI: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant."
11173839|NCT02018445|FG000|Participant Flow|All Patients|Posterolateral fusion study in which each patient undergoes posterolateral fusion (PLF). During the PLF, each spinal level is treated with two graft materials, the symptomatic posterolateral gutter is treated with study arm (Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
11228168|NCT02388568|EG000|Reported Event|Lorcaserin Plus Lifestyle Modification|Lorcaserin: Lorcaserin plus Lifestyle Modification
11154874|NCT01905241|EG000|Reported Event|Anatomic TSA Using RTI|"During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.~Anatomic TSA using RTI: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.~Anatomic Total Shoulder Arthroplasty: Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant."
11154875|NCT01905254|BG000|Baseline|Single Arm Study|Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.
11154876|NCT01905254|FG000|Participant Flow|Transient Elastography and Liver Biopsy|"Transient elastography was performed by two experienced investigators using a FibroScan (EchoSens, Paris, France), the median value of liver stiffness measurements was recorded in kilopascals (kPa).~Liver biopsy was carried out within 3 months of TE. Liver biopsies from the right and left lobe were obtained under laparoscopic control using the Tru-cut 16 GAUGE needle (Bard monopty; Bard biopsy systems, Tempe, USA).~Data analysis was performed on the remaining 34 patients (female: 28 (82%); male: 6 (18 %).~Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in."
11154877|NCT01905254|OG000|Outcome|Transient Elastography in Autoimmune Hepatitis|Liver stiffness (kPa) was correlated to histologic staging of liver cirrhosis
11154878|NCT01905254|EG000|Reported Event|TE in Autoimmune Hepatitis|"Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.~There were no adverse events."
11154879|NCT01905267|BG000|Baseline|Treatment|"Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy~Rumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length."
11154880|NCT01905267|BG001|Baseline|Control|Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
11154881|NCT01905267|BG002|Baseline|Total|Total of all reporting groups
11154882|NCT01905267|FG000|Participant Flow|Treatment|"Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy~Rumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length."
11154883|NCT01905267|FG001|Participant Flow|Control|Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
11154884|NCT01905267|OG000|Outcome|Treatment|"Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy~Rumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length."
11154885|NCT01905267|OG001|Outcome|Control|Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
11154886|NCT01905267|EG000|Reported Event|Treatment|"Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy~Rumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length."
11154887|NCT01905267|EG001|Reported Event|Control|Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
11154888|NCT01905423|BG000|Baseline|Annual MDA Treated Group (Paga)|"This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
11154889|NCT01905423|BG001|Baseline|Annual MDA Treated Group (Lewomada)|"This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
11228169|NCT02388568|EG001|Reported Event|Placebo Plus Lifestyle Modification|Placebo: Placebo plus Lifestyle Modification
11154890|NCT01905423|BG002|Baseline|Semiannual MDA Treated Group|"This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
11349153|NCT04096365|BG000|Baseline|Subcostal Temporary Extracardiac Pacing Lead|"All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.~Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance."
11154891|NCT01905423|BG003|Baseline|Annual MDA Treated Group (Pekalongan)|"The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites.~This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
11154892|NCT01905423|BG004|Baseline|Semiannual MDA Treated Group (Pekalongan)|"The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites.~This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
11154893|NCT01905423|BG005|Baseline|Total|Total of all reporting groups
11154894|NCT01905423|FG000|Participant Flow|Paga (1x Annual MDA)|The village of Paga received once annual MDA for a total of 3 rounds over 24 months.
11154895|NCT01905423|FG001|Participant Flow|Lewomada (1x Annual MDA)|Village of Lewomada received once annual MDA for a total of 3 rounds over 24 months.
11154896|NCT01905423|FG002|Participant Flow|Pruda (2x Annual MDA)|The village of Pruda received twice annual MDA for a total of 5 rounds over 24 months.
11154897|NCT01905423|FG003|Participant Flow|Pekalongan (1x Annual MDA)|The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group received one round of MDA and was surveyed one year later.
11154898|NCT01905423|FG004|Participant Flow|Pekalongan (2x Annual MDA)|The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group received two rounds of MDA and was surveyed one year later.
11154899|NCT01905423|OG000|Outcome|Paga (1x Annual MDA)|"Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly"
11154900|NCT01905423|OG001|Outcome|Lewomada (1x Annual MDA)|"Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly"
11154901|NCT01905423|OG002|Outcome|Pruda (2x Annual MDA)|"Participants from this village receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly"
11154902|NCT01905423|OG003|Outcome|Pekalongan (1x Annual MDA)|"Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly"
11154903|NCT01905423|OG004|Outcome|Pekalongan (2x Annual MDA)|"Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly"
11154904|NCT01905423|EG000|Reported Event|Paga (Annual MDA)|"This group includes eligible residents of the village of Paga. This cohort will receive once yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Paga received a total of three rounds of MDA over a period of 24 months (once every 12 months)."
11154905|NCT01905423|EG001|Reported Event|Lewomada (Annual MDA)|"This group includes eligible residents of the village of Lewomada. This cohort will receive once yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Lewomada received a total of three rounds of MDA over a period of 24 months (once every 12 months)."
10887711|NCT00502593|BG010|Baseline|GSK1562902A-C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11154906|NCT01905423|EG002|Reported Event|Pruda (Semiannual MDA)|"This group includes eligible residents of the village of Pruda. This cohort will receive twice yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Pruda received a total of five rounds of MDA over a period of 24 months (once every 6 months)."
11154907|NCT01905423|EG003|Reported Event|Pekalongan (Annual MDA)|"This group includes villages of Banyurip Ageng and Jenggot. This cohort will receive once yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis."
11154908|NCT01905423|EG004|Reported Event|Pekalongan (Semiannual MDA)|"This group includes villages of Kertoharjo and Pabean. This cohort will receive twice yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis."
11154909|NCT01905540|BG000|Baseline|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
11154910|NCT01905540|BG001|Baseline|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
11154911|NCT01905540|BG002|Baseline|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
11154912|NCT01905540|BG003|Baseline|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
11154913|NCT01905540|BG004|Baseline|Total|Total of all reporting groups
11154914|NCT01905540|FG000|Participant Flow|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
11154915|NCT01905540|FG001|Participant Flow|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
11154916|NCT01905540|FG002|Participant Flow|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
11154917|NCT01905540|FG003|Participant Flow|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
11154918|NCT01905540|OG000|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
11154919|NCT01905540|OG001|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
11154920|NCT01905540|OG000|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
11154921|NCT01905540|OG001|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
11154922|NCT01905540|EG000|Reported Event|SSP-004184AQ (Single Dose)|SSP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
11154923|NCT01905540|EG001|Reported Event|SSP-004184SS (Single Dose)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
11154924|NCT01905540|EG002|Reported Event|SSP-004184AQ (2 Doses)|SP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered in the morning and 40mg/kg administered 12 hours later.
11154925|NCT01905540|EG003|Reported Event|SSP-004184SS (2 Doses)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered in the morning and 21.8mg/kg administered 12 hours later.
11154926|NCT01905553|BG000|Baseline|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
11154927|NCT01905553|BG001|Baseline|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
11154928|NCT01905553|BG002|Baseline|Total|Total of all reporting groups
11154929|NCT01905553|FG000|Participant Flow|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
11154930|NCT01905553|FG001|Participant Flow|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
11154931|NCT01905553|OG000|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
11154932|NCT01905553|OG001|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
11154933|NCT01905553|EG000|Reported Event|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
11154934|NCT01905553|EG001|Reported Event|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
11154935|NCT01905592|BG000|Baseline|Physician's Choice|Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.
11154936|NCT01905592|BG001|Baseline|Niraparib|Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
11154937|NCT01905592|BG002|Baseline|Total|Total of all reporting groups
11154938|NCT01905592|FG000|Participant Flow|Physician's Choice|Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.
11154939|NCT01905592|FG001|Participant Flow|Niraparib|Niraparib 300 milligram (mg) (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
11154940|NCT01905592|OG000|Outcome|Physician's Choice|Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.
11154941|NCT01905592|OG001|Outcome|Niraparib|Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
11154942|NCT01905592|EG000|Reported Event|Physician's Choice|Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.
11154943|NCT01905592|EG001|Reported Event|Niraparib|Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
11154944|NCT01905657|BG000|Baseline|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
11154945|NCT01905657|BG001|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
11154946|NCT01905657|BG002|Baseline|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
11154947|NCT01905657|BG003|Baseline|Total|Total of all reporting groups
11154948|NCT01905657|FG000|Participant Flow|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
11154949|NCT01905657|FG001|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
11154950|NCT01905657|FG002|Participant Flow|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
11154951|NCT01905657|OG000|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
11154952|NCT01905657|OG001|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
11154953|NCT01905657|OG002|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
11154954|NCT01905657|EG000|Reported Event|Pembrolizumab 2 mg/kg First Course|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
11154955|NCT01905657|EG001|Reported Event|Pembrolizumab 10 mg/kg First Course|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
11154956|NCT01905657|EG002|Reported Event|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years.
11154957|NCT01905657|EG003|Reported Event|Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course|Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
11154958|NCT01905657|EG004|Reported Event|Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course|Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
11154959|NCT01905657|EG005|Reported Event|Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg|Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
11154960|NCT01905683|BG000|Baseline|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
11154961|NCT01905683|FG000|Participant Flow|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with gross motor function classification system expanded and revised (GMFCS-E&R) levels I to III.
11154962|NCT01905683|OG000|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
11154963|NCT01905683|EG000|Reported Event|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
11154964|NCT01905943|BG000|Baseline|Obinutuzumab|Participants received obinutuzumab either alone as single agent, or in combination with chemotherapy (Fludarabine/Cyclophosphamide [FC], Bendamustine or Chlorambucil).
11154965|NCT01905943|FG000|Participant Flow|Obinutuzumab|Participants received obinutuzumab either alone as single agent, or in combination with chemotherapy (Fludarabine/Cyclophosphamide [FC], Bendamustine or Chlorambucil).
11154966|NCT01905943|OG000|Outcome|Obinutuzumab|Participants received obinutuzumab either alone as single agent, or in combination with chemotherapy (Fludarabine/Cyclophosphamide [FC], Bendamustine or Chlorambucil).
11154967|NCT01905943|OG000|Outcome|G Mono: Previously Untreated Fit|Participants with obinutuzumab monotherapy who were previously untreated fit. Fit participants were defined as having a total Cumulative Illness Rating Scale (CIRS) score ≤6 and creatinine clearance (CrCl) ≥70 mL/min.
11154968|NCT01905943|OG001|Outcome|G Mono: Previously Untreated Unfit|Participants with obinutuzumab monotherapy who were previously untreated unfit. Non fit participants were defined as having a CIRS score >6 and/or CrCl <70 mL/min.
11154969|NCT01905943|OG002|Outcome|G Mono: Relapsed/Refractory|Participants with obinutuzumab monotherapy who had documented relapsed/refractory chronic lymphocytic leukemia (CLL).
11154970|NCT01905943|OG003|Outcome|G-Benda: Previously Untreated Fit|Participants with obinutuzumab in combination with bendamustine who were previously untreated fit. Fit participants were defined as having a total CIRS score <=6 and CrCl >=70 mL/min.
11154971|NCT01905943|OG004|Outcome|G-Benda: Previously Untreated Unfit|Participants with obinutuzumab in combination with bendamustine who were previously untreated unfit. Non fit Participants were defined as having a CIRS score >6 and/or CrCl <70 mL/min.
11154972|NCT01905943|OG005|Outcome|G-Benda: Relapsed/Refractory|Participants with obinutuzumab in combination with bendamustine who had documented relapsed/refractory chronic lymphocytic leukemia (CLL).
11154973|NCT01905943|OG006|Outcome|G-FC: Previously Untreated Fit|Participants with obinutuzumab in combination with fludarabine and cyclophosphamide who were previously untreated fit. Fit subjects were defined as having a total CIRS score <=6 and CrCl >=70 mL/min.
11154974|NCT01905943|OG007|Outcome|G-FC: Previously Untreated Unfit|Participants with obinutuzumab in combination with fludarabine and cyclophosphamide who were previously untreated unfit. Non fit participants were defined as having a CIRS score >6 and/or CrCl <70 mL/min. This is a Protocol deviation: unfit subjects were incorrectly assigned to the G-FC treatment regimen.
11154975|NCT01905943|OG008|Outcome|G-FC: Relapsed/Refractory|Participants with obinutuzumab in combination with fludarabine and cyclophosphamide who had documented relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Protocol deviation: 5 unfit subjects were incorrectly assigned to this relapsed/refractory G-FC treatment regimen.
11154976|NCT01905943|OG009|Outcome|G-Clb: Previously Untreated Fit|Participants with obinutuzumab in combination with chlorambucil who were previously untreated fit. Fit participants were defined as having a total CIRS score <=6 and CrCl >=70 mL/min.
11154977|NCT01905943|OG010|Outcome|G-Clb: Previously Untreated Unfit|Participants with obinutuzumab in combination with chlorambucil who were previously untreated unfit. Non fit participants were defined as having a CIRS score >6 and/or CrCl <70 mL/min.
11154978|NCT01905943|OG011|Outcome|G-Clb: Relapsed/Refractory|Participants with obinutuzumab in combination with chlorambucil who had documented relapsed/refractory chronic lymphocytic leukemia (CLL).
11154979|NCT01905943|EG000|Reported Event|G-Mono|Participants received obinutuzumab alone as single agent.
11154980|NCT01905943|EG001|Reported Event|G-Benda|Participants received obinutuzumab in combination with bendamustine.
11154981|NCT01905943|EG002|Reported Event|G-FC|Participants received obinutuzumab in combination with fludarabine/cyclophosphamide (FC).
11154982|NCT01905943|EG003|Reported Event|G-Clb|Participants received obinutuzumab in combination with chlorambucil.
11154983|NCT01905956|BG000|Baseline|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
11154984|NCT01905956|BG001|Baseline|Placebo|"2 capsules per dose, 3 times daily~Placebo"
11154985|NCT01905956|BG002|Baseline|Total|Total of all reporting groups
11154986|NCT01905956|FG000|Participant Flow|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
11154987|NCT01905956|FG001|Participant Flow|Placebo|"2 capsules per dose, 3 times daily~Placebo"
11154988|NCT01905956|OG000|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
11154989|NCT01905956|OG001|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
11154990|NCT01905956|EG000|Reported Event|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
11154991|NCT01905956|EG001|Reported Event|Placebo|"2 capsules per dose, 3 times daily~Placebo"
11154992|NCT01906008|BG000|Baseline|Minocycline|Minocycline 100 mg twice a day during 4 months
11154993|NCT01906008|BG001|Baseline|Placebo|Placebo 100 mg twice a day during 4 months
11154994|NCT01906008|BG002|Baseline|Total|Total of all reporting groups
11154995|NCT01906008|FG000|Participant Flow|Minocycline|Minocycline 100 mg twice a day during 4 months
11154996|NCT01906008|FG001|Participant Flow|Placebo|Placebo 100 mg twice a day during 4 months
11154997|NCT01906008|OG000|Outcome|Minocycline|Minocycline 100 mg twice a day during 4 months
11154998|NCT01906008|OG001|Outcome|Placebo|Placebo 100 mg twice a day during 4 months
11154999|NCT01906008|EG000|Reported Event|Minocycline|Minocycline 100 mg twice a day during 4 months
11155000|NCT01906008|EG001|Reported Event|Placebo|Placebo 100 mg twice a day during 4 months
11155001|NCT01906346|BG000|Baseline|Randomized Combination of One Drug Dose and One Money Value|"Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions.~Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions.~Placebo: Placebo cocaine is made available for self-administration during experimental sessions."
11155002|NCT01906346|FG000|Participant Flow|Randomized Combination of One Drug Dose and One Money Value|"Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions.~Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions.~Placebo: Placebo cocaine is made available for self-administration during experimental sessions."
11155003|NCT01906346|OG000|Outcome|Low Value Alternative Reinforcer|"A low value reinforcer was made available as an alternative to cocaine and placebo.~Cocaine: Three active doses of cocaine will be made available for self-administration during experimental sessions.~Placebo: Placebo cocaine will be made available for self-administration during experimental sessions."
11155004|NCT01906346|OG001|Outcome|Medium Value Reinforcer|"A medium value reinforcer was made available as an alternative to cocaine and placebo.~Cocaine: Three active doses of cocaine will be made available for self-administration during experimental sessions.~Placebo: Placebo cocaine will be made available for self-administration during experimental sessions."
11155005|NCT01906346|OG002|Outcome|High Value Reinforcer|"A high value reinforcer was made available as an alternative to cocaine and placebo.~Cocaine: Three active doses of cocaine will be made available for self-administration during experimental sessions.~Placebo: Placebo cocaine will be made available for self-administration during experimental sessions."
11155006|NCT01906346|EG000|Reported Event|Randomized Combination of One Drug Dose and One Money Value|"Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions.~Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions.~Placebo: Placebo cocaine is made available for self-administration during experimental sessions."
11155007|NCT01906372|BG000|Baseline|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
11155008|NCT01906372|FG000|Participant Flow|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel) 80 units (1 ml) twice a week for a period of six months.
11155009|NCT01906372|OG000|Outcome|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel) in active and refractory PM and DM patients using an open label design for 6 months. Study subjects self-administered subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week subcutaneously for a period of six months.
11155010|NCT01906372|OG000|Outcome|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. 10 active and refractory PM/DM patients were evaluated over a 15 month period, followed by 6 months of additional follow-up for each subject. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
11155011|NCT01906372|EG000|Reported Event|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. 10 active and refractory PM/DM patients were evaluated over a 15 month period, followed by 6 months of additional follow-up for each subject. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
11155012|NCT01906476|BG000|Baseline|Stepped Care|"Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist~Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist"
11155013|NCT01906476|BG001|Baseline|Telephone Cognitive Behavior Therapy|"Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).~Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT)."
11155014|NCT01906476|BG002|Baseline|Total|Total of all reporting groups
11155015|NCT01906476|FG000|Participant Flow|Stepped Care|"Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist~Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist"
11155016|NCT01906476|FG001|Participant Flow|Telephone Cognitive Behavior Therapy|"Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).~Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT)."
11155017|NCT01906476|OG000|Outcome|Stepped Care|"Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist~Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist"
11155018|NCT01906476|OG001|Outcome|Telephone Cognitive Behavior Therapy|"Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).~Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT)."
11155019|NCT01906476|EG000|Reported Event|Stepped Care|"Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist~Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist"
11155020|NCT01906476|EG001|Reported Event|Telephone Cognitive Behavior Therapy|"Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).~Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT)."
11155021|NCT01906515|BG000|Baseline|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
11155022|NCT01906515|BG001|Baseline|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
11155023|NCT01906515|BG002|Baseline|Total|Total of all reporting groups
11155024|NCT01906515|FG000|Participant Flow|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
11155025|NCT01906515|FG001|Participant Flow|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
11155026|NCT01906515|OG000|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
11155027|NCT01906515|OG001|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
11155028|NCT01906515|OG000|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm.~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
11155029|NCT01906515|EG000|Reported Event|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
11155030|NCT01906515|EG001|Reported Event|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
11155031|NCT01906658|BG000|Baseline|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155032|NCT01906658|BG001|Baseline|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155033|NCT01906658|BG002|Baseline|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155034|NCT01906658|BG003|Baseline|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155035|NCT01906658|BG004|Baseline|Total|Total of all reporting groups
11155036|NCT01906658|FG000|Participant Flow|Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155037|NCT01906658|FG001|Participant Flow|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155038|NCT01906658|FG002|Participant Flow|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155039|NCT01906658|FG003|Participant Flow|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155040|NCT01906658|OG000|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155041|NCT01906658|OG001|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155042|NCT01906658|OG002|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155043|NCT01906658|OG003|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155044|NCT01906658|EG000|Reported Event|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155045|NCT01906658|EG001|Reported Event|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155046|NCT01906658|EG002|Reported Event|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155047|NCT01906658|EG003|Reported Event|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
11155048|NCT01906866|BG000|Baseline|Circadin 2/5/10 mg|Circadin 2/5/10 mg: Active arm
11155049|NCT01906866|BG001|Baseline|Placebo|"Placebo arm~Placebo"
11155050|NCT01906866|BG002|Baseline|Total|Total of all reporting groups
11155051|NCT01906866|FG000|Participant Flow|Circadin 2/5/10 mg|Circadin 2/5/10 mg: Active arm
11155052|NCT01906866|FG001|Participant Flow|Placebo|"Placebo arm~Placebo"
11155053|NCT01906866|OG000|Outcome|Circadin 2/5/10 mg|Circadin 2/5/10 mg: Active arm Units: minutes arithmetic mean (standard error): 51.03 (±10.46)
11155054|NCT01906866|OG001|Outcome|Placebo|Placebo arm Units: minutes arithmetic mean (standard error): 18.71 (±10.82)
11155055|NCT01906866|OG000|Outcome|Circadin 2/5/10 mg|Circadin 2/5/10 mg: Active arm
11155056|NCT01906866|OG001|Outcome|Placebo|"Placebo arm~Placebo"
11155057|NCT01906866|EG000|Reported Event|Circadin 2/5/10 mg Double Blind|Circadin 2/5/10 mg: Active arm
11155058|NCT01906866|EG001|Reported Event|Placebo|"Placebo arm~Placebo"
11155059|NCT01906866|EG002|Reported Event|Circadin 2/5/10 mg Open Label|Circadin 2/5/10 mg Open label
11155060|NCT01907087|BG000|Baseline|300 mg BMN 190|Intracerebroventricular (ICV) infusion every two weeks.
11155061|NCT01907087|FG000|Participant Flow|300 mg BMN 190|"Intracerebroventricular (ICV) infusion every two weeks. This is a study of a single cohort followed for at least 48 weeks at dosing of 300 mg.~Subjects 1, 2, and 3 were initially assigned to the 30 mg dose, then escalated to 100 mg (and subsequently 300 mg) after data review. Subjects 4, 5, and 6 were initially assigned to the 100 mg dose, then escalated to 300 mg after data review. Subjects 7, 8 and 9 were initially assigned to the 300 mg dose. One patient withdrew after one dose due to unwillingness to comply with study procedures, requiring the addition of a 10th patient to this group. DMC approved full recruitment at the 300 mg dose (n=24) after data review."
11155062|NCT01907087|OG000|Outcome|300 mg BMN 190|Intracerebroventricular (ICV) infusion every two weeks.
11155063|NCT01907087|EG000|Reported Event|300 mg BMN 190|Intracerebroventricular (ICV) infusion every two weeks.
11155064|NCT01907100|BG000|Baseline|Placebo_Phase II|Phase II part: Nintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155065|NCT01907100|BG001|Baseline|Nintedanib_Phase II|Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155066|NCT01907100|BG002|Baseline|Placebo_Phase III|Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155067|NCT01907100|BG003|Baseline|Nintedanib_Phase III|Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155068|NCT01907100|BG004|Baseline|Total|Total of all reporting groups
11155069|NCT01907100|FG000|Participant Flow|Placebo_Phase II|"Phase II part:~Nintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction."
11155070|NCT01907100|FG001|Participant Flow|Nintedanib_Phase II|Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155071|NCT01907100|FG002|Participant Flow|Placebo_Phase III|Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155072|NCT01907100|FG003|Participant Flow|Nintedanib_Phase III|Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11173840|NCT02018445|OG000|Outcome|All Patients|Posterolateral fusion: each spinal level is treated with two graft materials, the posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
11155073|NCT01907100|OG000|Outcome|Placebo|Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155074|NCT01907100|OG001|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155075|NCT01907100|EG000|Reported Event|Placebo_Phase II|Phase II part: Nintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155076|NCT01907100|EG001|Reported Event|Nintedanib_Phase II|Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155077|NCT01907100|EG002|Reported Event|Placebo_Phase III|Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155078|NCT01907100|EG003|Reported Event|Nintedanib_Phase III|Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11155079|NCT01907113|BG000|Baseline|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155080|NCT01907113|BG001|Baseline|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155081|NCT01907113|BG002|Baseline|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155082|NCT01907113|BG003|Baseline|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155083|NCT01907113|BG004|Baseline|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
11155084|NCT01907113|BG005|Baseline|Total|Total of all reporting groups
11155085|NCT01907113|FG000|Participant Flow|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155086|NCT01907113|FG001|Participant Flow|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155087|NCT01907113|FG002|Participant Flow|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155088|NCT01907113|FG003|Participant Flow|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155089|NCT01907113|FG004|Participant Flow|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
11155090|NCT01907113|OG000|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155091|NCT01907113|OG001|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155092|NCT01907113|OG002|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155093|NCT01907113|OG003|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155094|NCT01907113|OG004|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
11155095|NCT01907113|EG000|Reported Event|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155096|NCT01907113|EG001|Reported Event|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155097|NCT01907113|EG002|Reported Event|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155098|NCT01907113|EG003|Reported Event|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
11155099|NCT01907113|EG004|Reported Event|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
11155100|NCT01907217|BG000|Baseline|Bilateral ECT Mecta 5000M|"Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155101|NCT01907217|BG001|Baseline|High-dose Unilateral ECT Mecta 5000M|"Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155102|NCT01907217|BG002|Baseline|Total|Total of all reporting groups
11155103|NCT01907217|FG000|Participant Flow|Bilateral ECT Mecta 5000M|"Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155104|NCT01907217|FG001|Participant Flow|High-dose Unilateral ECT Mecta 5000M|"Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155105|NCT01907217|OG000|Outcome|Bilateral ECT Mecta 5000M|"Modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure duration is measured by EEG monitoring. Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155106|NCT01907217|OG001|Outcome|High-dose Unilateral ECT Mecta 5000M|"Modified high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155107|NCT01907217|OG000|Outcome|Bilateral ECT Mecta 5000M|"Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155108|NCT01907217|OG001|Outcome|High-dose Unilateral ECT Mecta 5000M|"Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155109|NCT01907217|EG000|Reported Event|Bilateral ECT Mecta 5000M|"Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11155110|NCT01907217|EG001|Reported Event|High-dose Unilateral ECT Mecta 5000M|"Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks."
11173841|NCT02018445|OG000|Outcome|All Patients|Patients were treated at multiple levels. Accell Evo3 was placed in the posterolateral gutter of the symptomatic side and local autograft was used in the posterolateral gutter of the contralateral asymptomatic side.
11173842|NCT02018445|OG000|Outcome|All Patients|All patients
11173843|NCT02018445|OG000|Outcome|All Patients|
11173844|NCT02018445|EG000|Reported Event|All Patients|Patients were treated at multiple levels. Accell Evo3 was placed in the posterolateral gutter of the symptomatic side and local autograft was used in the posterolateral gutter of the contralateral asymptomatic side.
11173845|NCT02018458|BG000|Baseline|LA TNBC: DC Vaccine+Preop Chemo|LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy
11173846|NCT02018458|FG000|Participant Flow|LA TNBC: DC Vaccine+Preop Chemo|LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy.
11173847|NCT02018458|OG000|Outcome|LA TNBC: DC Vaccine+Preop Chemo|LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy
11173848|NCT02018458|EG000|Reported Event|LA TNBC: DC Vaccine+Preop Chemo|LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy.
11173849|NCT02018562|BG000|Baseline|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
11173850|NCT02018562|BG001|Baseline|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
11173851|NCT02018562|BG002|Baseline|Total|Total of all reporting groups
11173852|NCT02018562|FG000|Participant Flow|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
11173853|NCT02018562|FG001|Participant Flow|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
11173854|NCT02018562|OG000|Outcome|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
11155111|NCT01907269|BG000|Baseline|Video-based Intervention|"Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use story-telling delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.~Video-based Intervention: Video clips delivered by DVD and Internet"
11155112|NCT01907269|BG001|Baseline|Usual Care|
11155113|NCT01907269|BG002|Baseline|Total|Total of all reporting groups
11155114|NCT01907269|FG000|Participant Flow|Video-based Intervention|"Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use story-telling delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.~Video-based Intervention: Video clips delivered by DVD and Internet"
11155115|NCT01907269|FG001|Participant Flow|Usual Care|
11155116|NCT01907269|OG000|Outcome|Video-based Intervention|"Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use story-telling delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.~Video-based Intervention: Video clips delivered by DVD and Internet"
11155117|NCT01907269|OG001|Outcome|Usual Care|
11155118|NCT01907269|EG000|Reported Event|Video-based Intervention|"Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use story-telling delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.~Video-based Intervention: Video clips delivered by DVD and Internet"
11155119|NCT01907269|EG001|Reported Event|Usual Care|
11155120|NCT01907321|BG000|Baseline|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
11155121|NCT01907321|FG000|Participant Flow|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure. Once sufficient pressure is achieved (participant blowing out into the device) a valve is released, enabling airflow.~Measures performed on all subjects: Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system."
11155122|NCT01907321|OG000|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
11173855|NCT02018562|OG001|Outcome|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
10887712|NCT00502593|BG011|Baseline|Fluarix-C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887713|NCT00502593|BG012|Baseline|Total|Total of all reporting groups
10887714|NCT00502593|FG000|Participant Flow|GSK1562902A-A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887715|NCT00502593|FG001|Participant Flow|Fluarix-A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11155123|NCT01907321|EG000|Reported Event|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
11155124|NCT01907334|BG000|Baseline|All Participants|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg.
11155125|NCT01907334|FG000|Participant Flow|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
11155126|NCT01907334|FG001|Participant Flow|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
11155127|NCT01907334|OG000|Outcome|Increase in Airway Resistance After Methacholine|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg. On each study day after treatment, methacholine challenge was performed to determine provocational concentration of methacholine which caused a 40% increase in resistance at 5 Hz (PC40R5).
11155128|NCT01907334|EG000|Reported Event|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
11155129|NCT01907334|EG001|Reported Event|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
11155130|NCT01907490|BG000|Baseline|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
11155131|NCT01907490|FG000|Participant Flow|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
11155132|NCT01907490|OG000|Outcome|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
11155133|NCT01907490|OG000|Outcome|HA44 Gel 0.74%|"Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes~Ha44 Gel: Eligible subjects were treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair."
11155134|NCT01907490|EG000|Reported Event|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
11155135|NCT01907516|BG000|Baseline|Cell Phone-internet First, the Voicemail|Cell phone-internet home glucose reporting system first
11155136|NCT01907516|BG001|Baseline|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
11155137|NCT01907516|BG002|Baseline|Total|Total of all reporting groups
11155138|NCT01907516|FG000|Participant Flow|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first, then voicemail
11155139|NCT01907516|FG001|Participant Flow|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first, then cell phone-internet
11155140|NCT01907516|OG000|Outcome|Used Confidant Method|Cell phone-internet home based glucose monitoring first, then conventional Voicemail system for home glucose reporting
11155141|NCT01907516|OG001|Outcome|Used Voicemail Method|Voicemail first, then cell phone-internet home glucose monitoring system
11155142|NCT01907516|OG000|Outcome|Total Study Population|All study participants, includes those in cell phone-internet first, then voicemail and voicemail first, then cell phone-internet
11155143|NCT01907516|EG000|Reported Event|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first
11155144|NCT01907516|EG001|Reported Event|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
11155145|NCT01907607|BG000|Baseline|PD-0332991|"Adult patients with Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib.~PD-0332991 is formulated as gelatin capsules of 100 mg and 25 mg respectively.~PD-0332991 will be administrated orally, formulated as gelatin capsules of 100 mg and 25 mg respectively.: PD-0332991 dosed on a flat scale of 125 mg (1 capsule x 100 mg/day, 1 capsule x25 mg/day) will be administrated orally o.d on a 21 days on / 7 days off dosing schedule. One cycle is considered to consist of 4 weeks of PD-0332991 administration.~Patients should be instructed to administrate PD-0332991 with a sufficient amount of water at least 1 hour prior to a meal or at least 2 hours following a meal and to swallow the required number of capsules at approximately the same time on each day."
11155146|NCT01907607|FG000|Participant Flow|PD-0332991|"Adult patients with Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib.~PD-0332991 is formulated as gelatin capsules of 100 mg and 25 mg respectively.~PD-0332991 will be administrated orally, formulated as gelatin capsules of 100 mg and 25 mg respectively.: PD-0332991 dosed on a flat scale of 125 mg (1 capsule x 100 mg/day, 1 capsule x25 mg/day) will be administrated orally o.d on a 21 days on / 7 days off dosing schedule. One cycle is considered to consist of 4 weeks of PD-0332991 administration.~Patients should be instructed to administrate PD-0332991 with a sufficient amount of water at least 1 hour prior to a meal or at least 2 hours following a meal and to swallow the required number of capsules at approximately the same time on each day."
11155147|NCT01907607|OG000|Outcome|PD-0332991|"Adult patients with Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib.~PD-0332991 is formulated as gelatin capsules of 100 mg and 25 mg respectively.~PD-0332991 will be administrated orally, formulated as gelatin capsules of 100 mg and 25 mg respectively.: PD-0332991 dosed on a flat scale of 125 mg (1 capsule x 100 mg/day, 1 capsule x25 mg/day) will be administrated orally o.d on a 21 days on / 7 days off dosing schedule. One cycle is considered to consist of 4 weeks of PD-0332991 administration.~Patients should be instructed to administrate PD-0332991 with a sufficient amount of water at least 1 hour prior to a meal or at least 2 hours following a meal and to swallow the required number of capsules at approximately the same time on each day."
11155148|NCT01907607|EG000|Reported Event|PD-0332991|"Adult patients with Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib.~PD-0332991 is formulated as gelatin capsules of 100 mg and 25 mg respectively.~PD-0332991 will be administrated orally, formulated as gelatin capsules of 100 mg and 25 mg respectively.: PD-0332991 dosed on a flat scale of 125 mg (1 capsule x 100 mg/day, 1 capsule x25 mg/day) will be administrated orally o.d on a 21 days on / 7 days off dosing schedule. One cycle is considered to consist of 4 weeks of PD-0332991 administration.~Patients should be instructed to administrate PD-0332991 with a sufficient amount of water at least 1 hour prior to a meal or at least 2 hours following a meal and to swallow the required number of capsules at approximately the same time on each day."
11155149|NCT01907737|BG000|Baseline|Four Interventions in a Cross-over Design|"1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)~1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)~1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)~1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)"
11228170|NCT02388633|BG000|Baseline|Plasmapharesis|"Patients undergoing apheresis for elevated LDL. Patients will undergo contrast ultrasound perfusion imaging at rest and during forearm exercise at before and immediately after apheresis.~Plasmapharesis: Clinically-indicated LDL apheresis"
11155150|NCT01907737|FG000|Participant Flow|Four Interventions in a Cross-over Design|"Each subject participated in four sessions of interventions in different days.~1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)~1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)~1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)~1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)"
11155151|NCT01907737|OG000|Outcome|Active tDCS and Active PNS|"-1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)~Active tDCS and active PNS: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA).~Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator."
11155152|NCT01907737|OG001|Outcome|Active tDCS and Sham PNS|"-1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)~Active tDCS and sham PNS: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA). In sham PNS, the median, ulnar and radial nerves will not be actively stimulated."
11155153|NCT01907737|OG002|Outcome|Sham tDCS and Active PNS|"-1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)~Sham tDCS and active PNS: In sham tDCS, no current will be delivered through the tDCS device. Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator."
11155154|NCT01907737|OG003|Outcome|Sham tDCS and Sham PNS|"-1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)~Sham tDCS and sham PNS: No current will be delivered by the tDCS device, or to the radial, ulnar and median nerves."
11155155|NCT01907737|EG000|Reported Event|Active tDCS and Active PNS|"-1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)~Active tDCS and active PNS: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA).~Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator."
11155156|NCT01907737|EG001|Reported Event|Active tDCS and Sham PNS|"-1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)~Active tDCS and sham PNS: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA). In sham PNS, the median, ulnar and radial nerves will not be actively stimulated."
11155157|NCT01907737|EG002|Reported Event|Sham tDCS and Active PNS|"-1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)~Sham tDCS and active PNS: In sham tDCS, no current will be delivered through the tDCS device. Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator."
11155158|NCT01907737|EG003|Reported Event|Sham tDCS and Sham PNS|"-1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)~Sham tDCS and sham PNS: No current will be delivered by the tDCS device, or to the radial, ulnar and median nerves."
11155159|NCT01907815|BG000|Baseline|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
11155160|NCT01907815|BG001|Baseline|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
11155161|NCT01907815|BG002|Baseline|Total|Total of all reporting groups
11155162|NCT01907815|FG000|Participant Flow|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg orally once daily (PO QD) and Akt inhibitor GSK2141795 25 mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
11155163|NCT01907815|FG001|Participant Flow|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
11155164|NCT01907815|OG000|Outcome|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD & GSK2141795 25 mg PO QD on days 1-28.
11155165|NCT01907815|OG001|Outcome|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
11155166|NCT01907815|OG000|Outcome|Trametinib 2.0 + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
11155167|NCT01907815|OG000|Outcome|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
11155168|NCT01907815|EG000|Reported Event|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
11155169|NCT01907815|EG001|Reported Event|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
11155170|NCT01907828|BG000|Baseline|Renal Artery Ablation + Cardiac Ablation (RDN+AF)|Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
11155171|NCT01907828|BG001|Baseline|Cardiac Ablation (AF)|Participants treated with cardiac ablation alone.
11155172|NCT01907828|BG002|Baseline|Total|Total of all reporting groups
11155173|NCT01907828|FG000|Participant Flow|Renal Artery Ablation + Cardiac Ablation (RDN+AF)|Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
11155174|NCT01907828|FG001|Participant Flow|Cardiac Ablation (AF)|Participants treated with cardiac ablation alone.
11155175|NCT01907828|OG000|Outcome|Renal Artery Ablation + Cardiac Ablation (RDN+AF)|Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
11155176|NCT01907828|OG001|Outcome|Cardiac Ablation (AF)|Participants treated with cardiac ablation alone.
11155177|NCT01907828|EG000|Reported Event|Renal Artery Ablation + Cardiac Ablation (RDN+AF)|Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
11155178|NCT01907828|EG001|Reported Event|Cardiac Ablation (AF)|Participants treated with cardiac ablation alone.
11155179|NCT01907854|BG000|Baseline|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
11155180|NCT01907854|BG001|Baseline|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
11155181|NCT01907854|BG002|Baseline|Total|Total of all reporting groups
11228171|NCT02388633|FG000|Participant Flow|Plasmapharesis|"Patients undergoing apheresis for elevated LDL. Patients will undergo contrast ultrasound perfusion imaging at rest and during forearm exercise at before and immediately after apheresis.~Plasmapharesis: Clinically-indicated LDL apheresis"
11155182|NCT01907854|FG000|Participant Flow|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
11155183|NCT01907854|FG001|Participant Flow|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
11155184|NCT01907854|OG000|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
11155185|NCT01907854|OG001|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
11155186|NCT01907854|EG000|Reported Event|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
11155187|NCT01907854|EG001|Reported Event|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
11155188|NCT01907906|BG000|Baseline|Arm 1: Mirasol-treated WB Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
11155189|NCT01907906|BG001|Baseline|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49)
11155190|NCT01907906|BG002|Baseline|Total|Total of all reporting groups
11155191|NCT01907906|FG000|Participant Flow|Arm 1: Mirasol-treated Whole Blood (WB) Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, leuko-reduced packed red blood cells (LR-pRBCs) manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
11155192|NCT01907906|FG001|Participant Flow|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
11155193|NCT01907906|OG000|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
11155194|NCT01907906|OG001|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
11155195|NCT01907906|OG000|Outcome|Mirasol Treated|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from Mirasol-treated WB
11155196|NCT01907906|OG001|Outcome|Untreated Control|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from untreated WB
11155197|NCT01907906|EG000|Reported Event|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB.
11155198|NCT01907906|EG001|Reported Event|Untreated Control|LR-pRBCs derived from untreated WB
11155199|NCT01908062|BG000|Baseline|Treatment as Usual|"The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.~Treatment As usual"
11155200|NCT01908062|BG001|Baseline|Extended Release Naltrexone|"Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.~Extended Release Naltrexone"
11155201|NCT01908062|BG002|Baseline|Total|Total of all reporting groups
11155202|NCT01908062|FG000|Participant Flow|Treatment as Usual|"The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.~Treatment As usual"
11155203|NCT01908062|FG001|Participant Flow|Extended Release Naltrexone|"Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.~Extended Release Naltrexone"
11155204|NCT01908062|OG000|Outcome|Treatment as Usual|"The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.~Treatment As usual"
11155205|NCT01908062|OG001|Outcome|Extended Release Naltrexone|"Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.~Extended Release Naltrexone"
11155206|NCT01908062|OG000|Outcome|Treatment as Usual Pharmacotherapy|"The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. Pharmacotherapy for TAU participants with alcohol use disorder (AUD) consisted of oral naltrexone, gabapentin, acamprosate, and disulfiram.~Treatment As usual"
11155207|NCT01908062|OG000|Outcome|Treatment as Usual|"The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy.~Treatment As usual"
11155208|NCT01908062|OG000|Outcome|Extended Release Naltrexone|"Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.~Extended Release Naltrexone"
11155209|NCT01908062|EG000|Reported Event|Treatment as Usual|"The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.~Treatment As usual"
11155210|NCT01908062|EG001|Reported Event|Extended Release Naltrexone|"Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.~Extended Release Naltrexone"
11155211|NCT01908101|BG000|Baseline|Treatment (Eribulin Mesylate)|"Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11155212|NCT01908101|FG000|Participant Flow|Treatment (Eribulin Mesylate)|"Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11155213|NCT01908101|OG000|Outcome|Treatment (Eribulin Mesylate)|"Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11155214|NCT01908101|EG000|Reported Event|Treatment (Eribulin Mesylate)|"Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11155215|NCT01908127|BG000|Baseline|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
11155216|NCT01908127|BG001|Baseline|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
11155217|NCT01908127|BG002|Baseline|Total|Total of all reporting groups
11155218|NCT01908127|FG000|Participant Flow|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
11155219|NCT01908127|FG001|Participant Flow|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
11155220|NCT01908127|OG000|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
11155221|NCT01908127|OG001|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
11155222|NCT01908127|EG000|Reported Event|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
11155223|NCT01908127|EG001|Reported Event|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
11155224|NCT01908140|BG000|Baseline|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
11155225|NCT01908140|BG001|Baseline|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
11155226|NCT01908140|BG002|Baseline|Total|Total of all reporting groups
11155227|NCT01908140|FG000|Participant Flow|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
11155228|NCT01908140|FG001|Participant Flow|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
11155229|NCT01908140|OG000|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
11155230|NCT01908140|OG001|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
11155231|NCT01908140|EG000|Reported Event|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
11155232|NCT01908140|EG001|Reported Event|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
11155233|NCT01908205|BG000|Baseline|Intranasal Oxytocin (Syntocinon)|"The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose~Intranasal Oxytocin"
11155234|NCT01908205|BG001|Baseline|Placebo|"The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose~Placebo"
11155235|NCT01908205|BG002|Baseline|Total|Total of all reporting groups
11155236|NCT01908205|FG000|Participant Flow|Intranasal Oxytocin (Syntocinon)|"The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose~Intranasal Oxytocin"
11155237|NCT01908205|FG001|Participant Flow|Placebo|"The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose~Placebo"
11155238|NCT01908205|OG000|Outcome|Intranasal Oxytocin|Changes from baseline to week 12 on the ABC- Social Withdrawal
11155239|NCT01908205|OG001|Outcome|Placebo|Changes from baseline to week 24 on the ABC- Social Withdrawal
11155240|NCT01908205|OG000|Outcome|Intranasal Oxytocin|To examine the effect of IN-OXT vs. placebo on the Revised Eyes test at week 12
11155241|NCT01908205|OG001|Outcome|Placebo|To examine the effect of IN-OXT vs. placebo on the Revised Eyes test at week 12
11155242|NCT01908205|OG000|Outcome|Intranasal Oxytocin|To examine the effect of IN-OXT vs. placebo on measures of social cognition
11155243|NCT01908205|OG001|Outcome|Placebo|To examine the effect of IN-OXT vs. placebo on measures of social cognition
11155244|NCT01908205|OG000|Outcome|Intranasal Oxytocin|To examine the effect of IN-OXT vs. placebo on measures of social function
11155245|NCT01908205|OG000|Outcome|Intranasal Oxytocin|To examine the effect of IN-OXT vs. placebo on measures of repetitive behaviours
11155246|NCT01908205|OG001|Outcome|Placebo|To examine the effect of IN-OXT vs. placebo on measures of repetitive behaviours
11155247|NCT01908205|OG000|Outcome|Intranasal Oxytocin|To examine the effect of IN-OXT vs. placebo on measures of anxiety
11155248|NCT01908205|OG001|Outcome|Placebo|To examine the effect of IN-OXT vs. placebo on measures of anxiety
11155249|NCT01908205|OG000|Outcome|Intranasal Oxytocin|To examine the effect of IN-OXT vs. placebo on measures of quality of life
11155250|NCT01908205|OG001|Outcome|Placebo|To examine the effect of IN-OXT vs. placebo on measures of quality of life
11155251|NCT01908205|OG000|Outcome|Intranasal Oxytocin|To examine safety and tolerability of INOXT
11155252|NCT01908205|OG001|Outcome|Placebo|To examine safety and tolerability of INOXT
11155253|NCT01908205|EG000|Reported Event|Intranasal Oxytocin (Syntocinon)|"The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose~Intranasal Oxytocin"
11155254|NCT01908205|EG001|Reported Event|Placebo|"The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose~Placebo"
11155255|NCT01908426|BG000|Baseline|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily~Cabozantinib tablets"
11155256|NCT01908426|BG001|Baseline|Placebo|"Oral cabozantinib-matched placebo tablet once daily~Placebo tablets"
11155257|NCT01908426|BG002|Baseline|Total|Total of all reporting groups
11155258|NCT01908426|FG000|Participant Flow|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily~Cabozantinib tablets"
11155259|NCT01908426|FG001|Participant Flow|Placebo|"Oral cabozantinib-matched placebo tablet once daily~Placebo tablets"
11155260|NCT01908426|OG000|Outcome|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily~Cabozantinib tablets"
11155261|NCT01908426|OG001|Outcome|Placebo|"Oral cabozantinib-matched placebo tablet once daily~Placebo tablets"
11155262|NCT01908426|EG000|Reported Event|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily~Cabozantinib tablets"
11155263|NCT01908426|EG001|Reported Event|Placebo|"Oral cabozantinib-matched placebo tablet once daily~Placebo tablets"
11155264|NCT01908530|BG000|Baseline|Microprobe Glucose Sensor Phase 1|The microprobe array continuous glucose sensor applied to healthy volunteers for 6 h
11155265|NCT01908530|BG001|Baseline|Microprobe Glucose Sensor Phase 2|The microprobe array continuous glucose sensor will be applied to healthy volunteers for 24 h
11155266|NCT01908530|BG002|Baseline|Microprobe Glucose Sensor Phase 3|The microprobe array continuous glucose sensor applied to participants with type 1 diabetes
11155267|NCT01908530|BG003|Baseline|Total|Total of all reporting groups
11155268|NCT01908530|FG000|Participant Flow|Microprobe Glucose Sensor Phase 1|The microprobe array continuous glucose sensor applied to healthy volunteers for 6h
11155269|NCT01908530|FG001|Participant Flow|Microprobe Glucose Sensor Phase 2|The microprobe array continuous glucose sensor applied to healthy volunteers for 24 h
11155270|NCT01908530|FG002|Participant Flow|Microprobe Glucose Sensor Phase 3|The microprobe array continuous glucose sensor applied to participants with type 1 diabetes
11155271|NCT01908530|OG000|Outcome|Microprobe Glucose Sensor Phase 1|The microprobe array continuous glucose sensor applied to healthy volunteers for 6 h
11155272|NCT01908530|OG001|Outcome|Microprobe Glucose Sensor Phase 2|The microprobe array continuous glucose sensor applied to healthy volunteers for 24 h
11155273|NCT01908530|OG002|Outcome|Microprobe Glucose Sensor Phase 3|The microprobe array continuous glucose sensor applied to participants with type 1 diabetes
11155274|NCT01908530|OG000|Outcome|Microprobe Glucose Sensor Phase 1|The microprobe array continuous glucose sensor applied to healthy volunteers for 6h
11155275|NCT01908530|OG001|Outcome|Microprobe Glucose Sensor Phase 2|The microprobe array continuous glucose sensor applied to healthy volunteers for 24h
11155276|NCT01908530|OG001|Outcome|Microprobe Glucose Sensor Phase 2|The microprobe array continuous glucose sensor will be applied to healthy volunteers for 24 h
11155277|NCT01908530|EG000|Reported Event|Microprobe Glucose Sensor Phase 1|The microprobe array continuous glucose sensor applied to healthy volunteers for 6 h
11155278|NCT01908530|EG001|Reported Event|Microprobe Glucose Sensor Phase 2|The microprobe array continuous glucose sensor applied to healthy volunteers for 24 h
11155279|NCT01908530|EG002|Reported Event|Microprobe Glucose Sensor Phase 3|The microprobe array continuous glucose sensor applied to participants with type 1 diabetes
11155280|NCT01908582|BG000|Baseline|All Participants|"Period 1:~Evacetrapib 130 mg administered orally as a single dose on Day 1~Period 2:~Rifampin 600 mg administered orally QD of Days 9 to 22 Evacetrapib 130 mg administered orally as a single dose on Day 16"
11155281|NCT01908582|FG000|Participant Flow|All Participants|"Period 1:~Evacetrapib 130 milligrams (mg) administered orally as a single dose on Day 1~Period 2:~Rifampin 600 mg administered orally once daily (QD) of Days 9 to 22 Evacetrapib 130 mg administered orally as a single dose on Day 16"
11155282|NCT01908582|OG000|Outcome|Evacetrapib|"Period 1:~Evacetrapib 130 mg administered orally as a single dose on Day 1"
11155283|NCT01908582|OG001|Outcome|Evacetrapib + Rifampin|"Period 2:~Rifampin 600 mg administered orally, QD on Days 9 to 22 (14 consecutive days)~Evacetrapib 130 mg administered orally as a single dose on Day 16"
11155284|NCT01908582|EG000|Reported Event|Evacetrapib|"Period 1:~Evacetrapib 130 mg administered orally as a single dose on Day 1."
11155285|NCT01908582|EG001|Reported Event|Rifampin|"Period 2:~600 mg rifampin administered orally as a single dose QD on Days 9 through 15."
11155286|NCT01908582|EG002|Reported Event|Evacetrapib + Rifampin|"Period 2:~Rifampin 600 mg administered orally, QD on Days 16 to 22~Evacetrapib 130 mg administered orally as a single dose on Day 16"
11155287|NCT01908634|BG000|Baseline|All Participants|All participants, measured at screening visit
11155288|NCT01908634|FG000|Participant Flow|All Participants|All participants received multiple interventions in *1* sequence (i.e., Water-based Strawberry Beverage With Meal first, then Milk-based Strawberry Beverage With Meal, then Water-based Strawberry Beverage Without Meal, then Milk-based Strawberry Beverage Without Meal)
11155289|NCT01908634|OG000|Outcome|Milk-based Strawberry Beverage no Meal|"Milk-based Strawberry beverage without meal~Milk-based Strawberry Beverage without meal"
10851400|NCT00306202|OG001|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
11155290|NCT01908634|OG001|Outcome|Water-based Strawberry Beverage no Meal|"Water-based Strawberry beverage without meal~Water-Based Strawberry Beverage without meal"
11155291|NCT01908634|OG002|Outcome|Milk-based Strawberry Beverage With Meal|"Milk-based Strawberry beverage with meal~Milk-based strawberry Beverage with meal"
11155292|NCT01908634|OG003|Outcome|Water-based Strawberry Beverage With Meal|"Water-based Strawberry beverage with meal~Water-Based strawberry Beverage with meal"
11155293|NCT01908634|EG000|Reported Event|Without Meal|Milk-based strawberry Beverage without a meal vs. Water-based strawberry Beverage without a meal
11155294|NCT01908634|EG001|Reported Event|With Meal|Milk-based strawberry Beverage with a meal vs. Water-based strawberry Beverage with a meal
11155295|NCT01908699|BG000|Baseline|Esuberaprost|Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
11155296|NCT01908699|BG001|Baseline|Placebo|Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
11155297|NCT01908699|BG002|Baseline|Total|Total of all reporting groups
11155298|NCT01908699|FG000|Participant Flow|Esuberaprost|Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
11155299|NCT01908699|FG001|Participant Flow|Placebo|Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
11155300|NCT01908699|OG000|Outcome|Esuberaprost|Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
11155301|NCT01908699|OG001|Outcome|Placebo|Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
11155302|NCT01908699|EG000|Reported Event|Esuberaprost|Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
11155303|NCT01908699|EG001|Reported Event|Placebo|Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
11155304|NCT01908751|BG000|Baseline|Sliding Hip Screw + Vitamin D Supplementation|Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
11155305|NCT01908751|BG001|Baseline|Cancellous Screws + Vitamin D Supplementation|Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
11155306|NCT01908751|BG002|Baseline|Sliding Hip Screw + Vitamin D Placebo|Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company.
11155307|NCT01908751|BG003|Baseline|Cancellous Screws + Vitamin D Placebo|Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company.
11155308|NCT01908751|BG004|Baseline|Total|Total of all reporting groups
11155309|NCT01908751|FG000|Participant Flow|Sliding Hip Screw + Vitamin D Supplementation|Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
11155310|NCT01908751|FG001|Participant Flow|Cancellous Screws + Vitamin D Supplementation|Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
11155311|NCT01908751|FG002|Participant Flow|Sliding Hip Screw + Vitamin D Placebo|Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company.
11155312|NCT01908751|FG003|Participant Flow|Cancellous Screws + Vitamin D Placebo|Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company.
11155313|NCT01908751|OG000|Outcome|Sliding Hip Screw|Participants allocated to the Sliding Hip Screw group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate.
11155314|NCT01908751|OG001|Outcome|Cancellous Screws|Participants allocated to the Cancellous Screws group received multiple cancellous screws with a minimum diameter of 6.5 mm.
11155315|NCT01908751|OG002|Outcome|Vitamin D Supplementation|Participants allocated to the vitamin D Group were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
11155316|NCT01908751|OG003|Outcome|Vitamin D Placebo|Participants in the placebo group received an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company.
11155317|NCT01908751|EG000|Reported Event|Sliding Hip Screw + Vitamin D Supplementation|Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
11155318|NCT01908751|EG001|Reported Event|Cancellous Screws + Vitamin D Supplementation|Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
11155319|NCT01908751|EG002|Reported Event|Sliding Hip Screw + Vitamin D Placebo|Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company.
11155320|NCT01908751|EG003|Reported Event|Cancellous Screws + Vitamin D Placebo|Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company.
11155321|NCT01908803|BG000|Baseline|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
11155322|NCT01908803|BG001|Baseline|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
11155323|NCT01908803|BG002|Baseline|Total|Total of all reporting groups
11155324|NCT01908803|FG000|Participant Flow|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
11155325|NCT01908803|FG001|Participant Flow|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
11155326|NCT01908803|OG000|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
11155327|NCT01908803|OG001|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
11155328|NCT01908803|EG000|Reported Event|Pre-treatment|Includes all subjects prior to administration of study medication
11155329|NCT01908803|EG001|Reported Event|AL-60371/AL-817|Includes all subjects administered a dose of AL-60371/AL-817
11155330|NCT01908803|EG002|Reported Event|CIPRODEX|Includes all subjects administered a dose of CIPRODEX®
11155331|NCT01908816|BG000|Baseline|CNV (Choroidal Neovascularization)|All patients received 0.5 mg ranibizumab IVT injection
11155332|NCT01908816|BG001|Baseline|ME (Macular Edema)|All patients received 0.5 mg ranibizumab IVT injection
11155333|NCT01908816|BG002|Baseline|RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)|All patients received 0.5 mg ranibizumab IVT injection
11155334|NCT01908816|BG003|Baseline|PDR/V|(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
11155335|NCT01908816|BG004|Baseline|Total|Total of all reporting groups
11155336|NCT01908816|FG000|Participant Flow|CNV (Choroidal Neovascularization)|All patients received 0.5 mg ranibizumab IVT injection
11155337|NCT01908816|FG001|Participant Flow|ME (Macular Edema)|All patients received 0.5 mg ranibizumab IVT injection
11155338|NCT01908816|FG002|Participant Flow|RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)|All patients received 0.5 mg ranibizumab IVT injection
11155339|NCT01908816|FG003|Participant Flow|PDR/V|(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
11155340|NCT01908816|OG000|Outcome|CNV (Choroidal Neovascularization)|All patients received 0.5 mg ranibizumab IVT injection
11155341|NCT01908816|OG001|Outcome|ME (Macular Edema)|All patients received 0.5 mg ranibizumab IVT injection
11155342|NCT01908816|OG002|Outcome|RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)|All patients received 0.5 mg ranibizumab IVT injection
11155343|NCT01908816|OG003|Outcome|PDR/V|(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
11155344|NCT01908816|OG000|Outcome|Ranibizumab 0.5 mg|All patients received 0.5 mg ranibizumab IVT injection
11155345|NCT01908816|OG000|Outcome|PDR/V|(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
11155346|NCT01908816|OG002|Outcome|PDR/V|(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
11155347|NCT01908816|EG000|Reported Event|Choroidal Neovascularization|Choroidal neovascularization
11155348|NCT01908816|EG001|Reported Event|Macular Edema|Macular edema
11155349|NCT01908816|EG002|Reported Event|Rubeosis Iridis/ Neovascular Glaucoma|Rubeosis iridis/ Neovascular glaucoma
11155350|NCT01908816|EG003|Reported Event|Proliferative Diabetic Retinopathy Requiring Vitrectomy|Proliferative diabetic retinopathy requiring vitrectomy
11155351|NCT01908829|BG000|Baseline|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
11155352|NCT01908829|BG001|Baseline|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
11155353|NCT01908829|BG002|Baseline|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
11155354|NCT01908829|BG003|Baseline|Total|Total of all reporting groups
11155355|NCT01908829|FG000|Participant Flow|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
11155356|NCT01908829|FG001|Participant Flow|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
11155357|NCT01908829|FG002|Participant Flow|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
11155358|NCT01908829|OG000|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
11155359|NCT01908829|OG001|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
11155360|NCT01908829|OG002|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
11155361|NCT01908829|EG000|Reported Event|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
11155362|NCT01908829|EG001|Reported Event|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
11155363|NCT01908829|EG002|Reported Event|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
11155364|NCT01908842|BG000|Baseline|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded); Days 3-14: BNX sublingual tablets (open-label); Days 15-21: Switch to BNX sublingual film (open-label); Day 22: End of study visit
11155365|NCT01908842|BG001|Baseline|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: BNX sublingual film (open-label); Days 15-21: Switch to BNX sublingual tablets (open-label); Day 22: End of study visit
11155366|NCT01908842|BG002|Baseline|Total|Total of all reporting groups
11155367|NCT01908842|FG000|Participant Flow|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3 to 14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
11155368|NCT01908842|FG001|Participant Flow|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
11155369|NCT01908842|OG000|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
11155370|NCT01908842|OG001|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
11155371|NCT01908842|EG000|Reported Event|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
11155372|NCT01908842|EG001|Reported Event|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
11155373|NCT01908907|BG000|Baseline|DHA Supplemented|Preterm infants (31) randomized to receive 50mg/d of enteral DHA supplementation
11155374|NCT01908907|BG001|Baseline|Placebo Supplemented|Preterm infants (29) randomized to receive placebo study oil
11155375|NCT01908907|BG002|Baseline|Total|Total of all reporting groups
11155376|NCT01908907|FG000|Participant Flow|DHA Oil|"DHA oil administered 50 mg/d (0.18ml)as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~DHA oil administered at 50 mg/d (0.18ml) Or MCT oil administered at 0.18 ml"
11155377|NCT01908907|FG001|Participant Flow|Medium Chain Triglyceride (MCT) Control Oil|"MCT oil administered 0.18ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion"
11155378|NCT01908907|OG000|Outcome|DHA Oil|"DHA oil administered 50 mg/d (0.18ml)as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~DHA oil administered at 50 mg/d (0.18ml) Or MCT oil administered at 0.18 ml"
11155379|NCT01908907|OG001|Outcome|(MCT) Control Oil|"MCT oil administered 0.18ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion"
11155380|NCT01908907|OG000|Outcome|DHA Supplemented|Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.
11155381|NCT01908907|OG001|Outcome|MCT (Placebo Control Group)|Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.
11155382|NCT01908907|OG000|Outcome|DHA Supplemented|"Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
11155383|NCT01908907|OG001|Outcome|MCT (Placebo Control Group)|"Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
11155384|NCT01908907|EG000|Reported Event|DHA Oil|"DHA oil administered 50 mg/d (0.18ml)as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~DHA oil administered at 50 mg/d (0.18ml) Or MCT oil administered at 0.18 ml"
11155385|NCT01908907|EG001|Reported Event|(MCT) Control Oil|"MCT oil administered 0.18ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion"
11155386|NCT01908972|BG000|Baseline|Prednisolone|"Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks~Prednisolone: 2mg/kg/day for 16weeks"
11155387|NCT01908972|BG001|Baseline|Propranolol|"Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks~Propranolol: 2mg/kg/day for 16weeks"
11155388|NCT01908972|BG002|Baseline|Total|Total of all reporting groups
11155389|NCT01908972|FG000|Participant Flow|Prednisolone|"Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks~Prednisolone: 2mg/kg/day for 16weeks"
11155390|NCT01908972|FG001|Participant Flow|Propranolol|"Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks~Propranolol: 2mg/kg/day for 16weeks"
11155391|NCT01908972|OG000|Outcome|Prednisolone|"Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks~Prednisolone: 2mg/kg/day for 16weeks"
11155392|NCT01908972|OG001|Outcome|Propranolol|"Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks~Propranolol: 2mg/kg/day for 16weeks"
11155393|NCT01908972|EG000|Reported Event|Prednisolone|"Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks~Prednisolone: 2mg/kg/day for 16weeks"
11155394|NCT01908972|EG001|Reported Event|Propranolol|"Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks~Propranolol: 2mg/kg/day for 16weeks"
11155395|NCT01909011|BG000|Baseline|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.~FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
11155396|NCT01909011|BG001|Baseline|Sham CES|"The CES sham group will receive sham CES (device off)for 20 minutes 5 times per week for two weeks.~Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
11155397|NCT01909011|BG002|Baseline|Total|Total of all reporting groups
11155398|NCT01909011|FG000|Participant Flow|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.~FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
11155399|NCT01909011|FG001|Participant Flow|Sham CES|"The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.~Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
11155400|NCT01909011|OG000|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
11155401|NCT01909011|OG001|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
11155402|NCT01909011|EG000|Reported Event|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for four weeks.
11155403|NCT01909011|EG001|Reported Event|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks (placebo period), and after cross-over into open-label phase participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for another two weeks.
11155404|NCT01909141|BG000|Baseline|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155405|NCT01909141|BG001|Baseline|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 will received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155406|NCT01909141|BG002|Baseline|Total|Total of all reporting groups
11155407|NCT01909141|FG000|Participant Flow|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155408|NCT01909141|FG001|Participant Flow|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155409|NCT01909141|OG000|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 receivde letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was be done for arm 1 for 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was caculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155410|NCT01909141|OG001|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155411|NCT01909141|OG000|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155412|NCT01909141|OG001|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155413|NCT01909141|EG000|Reported Event|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155414|NCT01909141|EG001|Reported Event|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
11155415|NCT01909154|BG000|Baseline|Mesenchymal Stromal Cell Therapy|"Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later~Mesenchymal stromal cell therapy"
11155416|NCT01909154|FG000|Participant Flow|Mesenchymal Stromal Cell Therapy|"Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later~Mesenchymal stromal cell therapy"
11155417|NCT01909154|OG000|Outcome|Mesenchymal Stromal Cell Therapy|"Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later~Mesenchymal stromal cell therapy"
11155418|NCT01909154|EG000|Reported Event|Mesenchymal Stromal Cell Therapy|"Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later~Mesenchymal stromal cell therapy"
11155419|NCT01909180|BG000|Baseline|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
11155420|NCT01909180|FG000|Participant Flow|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
11155421|NCT01909180|OG000|Outcome|Cardiac|Subjects who received a cardiac CT scan
11155422|NCT01909180|OG001|Outcome|Body/ Extremity|Subject receiving a Revolution CT scan of the body or extremities
11155423|NCT01909180|OG002|Outcome|Neuro|Subjects receiving Revolution CT Scans of Brain or Spinal Cord
11155424|NCT01909180|EG000|Reported Event|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
11155425|NCT01909336|BG000|Baseline|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|"Group 1: 0.3% Saline in 3.3% dextrose (intravenous)~0.3% Saline in 3.3% dextrose: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose"
11155426|NCT01909336|BG001|Baseline|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|"Group 2: 0.45% Saline in 5% dextrose (intravenous)~0.45% Saline in 5% dextrose: Hypotonic Solutions: 0.45% Saline in 5% dextrose"
11155427|NCT01909336|BG002|Baseline|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|"Group 3: 0.9% Saline in 5% dextrose (intravenous)~0.9% Saline in 5% dextrose: Isotonic Solutions 0.9% Saline in 5% dextrose"
11155428|NCT01909336|BG003|Baseline|Total|Total of all reporting groups
11155429|NCT01909336|FG000|Participant Flow|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
11155430|NCT01909336|FG001|Participant Flow|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
11155431|NCT01909336|FG002|Participant Flow|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
11155432|NCT01909336|OG000|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
11155433|NCT01909336|OG001|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
11155434|NCT01909336|OG002|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
11155435|NCT01909336|EG000|Reported Event|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
11155436|NCT01909336|EG001|Reported Event|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
11155437|NCT01909336|EG002|Reported Event|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
11155438|NCT01909466|BG000|Baseline|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
11155439|NCT01909466|FG000|Participant Flow|Gluteal/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
11155440|NCT01909466|FG001|Participant Flow|Deltoid/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the deltoid muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
11155441|NCT01909466|OG000|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
11155442|NCT01909466|EG000|Reported Event|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
11155443|NCT01909674|BG000|Baseline|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
11155444|NCT01909674|BG001|Baseline|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
11155445|NCT01909674|BG002|Baseline|Total|Total of all reporting groups
11155446|NCT01909674|FG000|Participant Flow|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
11155447|NCT01909674|FG001|Participant Flow|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
11155448|NCT01909674|OG000|Outcome|Total Sleep Time - Nasal Mask|"Total Sleep Time (TST)~The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode."
11155449|NCT01909674|OG001|Outcome|Total Sleep Time (TST) Oronasal Mask|"Total Sleep Time (TST)~The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode."
11155450|NCT01909674|EG000|Reported Event|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
11155451|NCT01909674|EG001|Reported Event|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
11155452|NCT01909713|BG000|Baseline|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
11155453|NCT01909713|FG000|Participant Flow|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
11155454|NCT01909713|OG000|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
11155455|NCT01909713|OG001|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
11155456|NCT01909713|OG002|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
11155457|NCT01909713|OG003|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
11155458|NCT01909713|OG000|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from baseline.
11155459|NCT01909713|OG001|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days, TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 1.
11155460|NCT01909713|OG002|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 3.
11155461|NCT01909713|OG000|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from baseline.
11155462|NCT01909713|OG001|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3.This arm shows the results from week 1.
11155463|NCT01909713|OG002|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from week 3.
11155464|NCT01909713|OG000|Outcome|I Liked Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
11155465|NCT01909713|OG001|Outcome|The Face Wash Was Easy to Use|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
11155466|NCT01909713|OG002|Outcome|The Face Wash Made my Skin Feel Clean|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
11155467|NCT01909713|OG003|Outcome|The Face Wash Rinsed Easily Off my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
11155468|NCT01909713|OG004|Outcome|I Would Keep Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
11155469|NCT01909713|OG005|Outcome|I Liked the Face Wash Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22). Subjects were only required to respond to this question if they had used a face wash previously.
11155470|NCT01909713|OG000|Outcome|I Liked Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
11357499|NCT03756506|BG000|Baseline|DuraDerm® Group|"All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge.~Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal."
11155471|NCT01909713|OG001|Outcome|The Lotion Smelled Good|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
11155472|NCT01909713|OG002|Outcome|The Lotion Spread Easily on my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
11155473|NCT01909713|OG003|Outcome|The Lotion Made my Skin Feel Soft|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
11155474|NCT01909713|OG004|Outcome|I Would Keep Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
11155475|NCT01909713|OG005|Outcome|I Liked the Lotion Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22). Subjects were only required to respond to this question if they had used a moisturizer previously.
11155476|NCT01909713|EG000|Reported Event|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
11155477|NCT01909778|BG000|Baseline|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg and 240 mg.~A number of 12 entered patients with compensated liver cirrhosis was planned."
11155478|NCT01909778|FG000|Participant Flow|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg first, 240 mg second.~A number of 12 entered patients with compensated liver cirrhosis was planned."
11155479|NCT01909778|OG000|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
11155480|NCT01909778|OG001|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
11155481|NCT01909778|EG000|Reported Event|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
11155482|NCT01909778|EG001|Reported Event|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
11155483|NCT01909791|BG000|Baseline|Initiation With Aflibercept|"Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met"
11155484|NCT01909791|BG001|Baseline|Initiation With Laser Photocoagulation|"Focal/grid laser followed by intravitreal aflibercept if vision worsens~Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155485|NCT01909791|BG002|Baseline|Initiation With Observation|"No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155486|NCT01909791|BG003|Baseline|Total|Total of all reporting groups
11155487|NCT01909791|FG000|Participant Flow|Initiation With Aflibercept|"Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met"
11155488|NCT01909791|FG001|Participant Flow|Initiation With Laser Photocoagulation|"Focal/grid laser followed by intravitreal aflibercept if vision worsens~Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155489|NCT01909791|FG002|Participant Flow|Initiation With Observation|"No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155490|NCT01909791|OG000|Outcome|Initiation With Aflibercept|"Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met"
11155491|NCT01909791|OG001|Outcome|Initiation With Laser Photocoagulation|"Focal/grid laser followed by intravitreal aflibercept if vision worsens~Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155492|NCT01909791|OG002|Outcome|Initiation With Observation|"No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155493|NCT01909791|OG000|Outcome|Initial Aflibercept|"Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met"
11155494|NCT01909791|OG001|Outcome|Initial Laser With Deferred Aflibercept if Needed|"Focal/grid laser followed by intravitreal aflibercept if vision worsens~Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155495|NCT01909791|OG002|Outcome|Observation|"No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155496|NCT01909791|OG000|Outcome|Initiation With Laser Photocoagulation|"Focal/grid laser followed by intravitreal aflibercept if vision worsens~Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155497|NCT01909791|OG001|Outcome|Initiation With Observation|"No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
10851401|NCT00306202|OG000|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
11155498|NCT01909791|EG000|Reported Event|Initiation With Laser Photocoagulation|"Focal/grid laser followed by intravitreal aflibercept if vision worsens~Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155499|NCT01909791|EG001|Reported Event|Initiation With Observation|"No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria"
11155500|NCT01909791|EG002|Reported Event|Initiation With Aflibercept|"Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria~Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met"
11155501|NCT01909804|BG000|Baseline|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
11155502|NCT01909804|BG001|Baseline|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
11155503|NCT01909804|BG002|Baseline|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
11155504|NCT01909804|BG003|Baseline|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
11155505|NCT01909804|BG004|Baseline|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
11155506|NCT01909804|BG005|Baseline|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
11155507|NCT01909804|BG006|Baseline|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
11155508|NCT01909804|BG007|Baseline|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
11155509|NCT01909804|BG008|Baseline|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
11155510|NCT01909804|BG009|Baseline|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
11155511|NCT01909804|BG010|Baseline|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
11155512|NCT01909804|BG011|Baseline|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
11155513|NCT01909804|BG012|Baseline|Total|Total of all reporting groups
11155514|NCT01909804|FG000|Participant Flow|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|Sofosbuvir (SOF) 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
11155515|NCT01909804|FG001|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
11155516|NCT01909804|FG002|Participant Flow|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
11155517|NCT01909804|FG003|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
11155518|NCT01909804|FG004|Participant Flow|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
11155519|NCT01909804|FG005|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
11155520|NCT01909804|FG006|Participant Flow|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
11089136|NCT01522235|OG000|Outcome|IVIg Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089137|NCT01522235|OG001|Outcome|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIG: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089138|NCT01522235|OG000|Outcome|IVIG Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089139|NCT01522235|OG001|Outcome|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089140|NCT01522235|OG000|Outcome|Group A|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089141|NCT01522235|OG001|Outcome|Group B|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089142|NCT01522235|EG000|Reported Event|IVIg Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089143|NCT01522235|EG001|Reported Event|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
11089144|NCT01522248|BG000|Baseline|Cohort 1|Received vaccine in morning. Blood drawn at 3, 7, 24 and 48 hours and 14 days after vaccination. Trivalent Inactivated Influenza vaccine 0.5ml IM once only
11089145|NCT01522248|BG001|Baseline|Cohort 2|Received vaccine in evening. Blood drawn 16 and 40 hours and 14 days after vaccination. Trivalent Inactivated Influenza vaccine 0.5 ml IM once only
11089146|NCT01522248|BG002|Baseline|Total|Total of all reporting groups
11089147|NCT01522248|FG000|Participant Flow|Cohort 1|"receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination.~Trivalent Inactivated Influenza vaccine: 0.5 ml IM once only"
11089148|NCT01522248|FG001|Participant Flow|Cohort 2|"receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination.~Trivalent Inactivated Influenza vaccine: 0.5 ml IM once only"
11089149|NCT01522248|OG000|Outcome|Cohort 1|Cytokine Results 0 hours and 24 hours
11089150|NCT01522248|OG001|Outcome|Cohort 2|Cytokine results 0hours and 16 hours
11089151|NCT01522248|OG002|Outcome|Cohort 1 & 2|Combined Cytokine results 0 hours and 14 days
11089152|NCT01522248|OG000|Outcome|Cohort 1|Cytokine results 0 hours and 24 hours
11089153|NCT01522248|OG001|Outcome|Cohort 2|Cytokine results 0 hours and 16 hours
11089154|NCT01522248|OG002|Outcome|Cohort 1 & 2|Combined cytokine results 0 hours and 14 days
11089155|NCT01522248|OG002|Outcome|Cohort 1 and 2|Cytokine results 0 hours and 14 days
11089156|NCT01522248|EG000|Reported Event|Cohort 1|Received vaccine in the morning
11089157|NCT01522248|EG001|Reported Event|Cohort 2|Received vaccine in the evening
11089158|NCT01522339|BG000|Baseline|Pilot Group|Patients who had an MRI in the NICU scanner.
11089159|NCT01522339|FG000|Participant Flow|Pilot Group|Patients who received an MRI.
11089160|NCT01522339|OG000|Outcome|Pilot Group|Patients who received an MRI on the NICU scanner.
11089161|NCT01522339|OG000|Outcome|Pilot Group|Patients who had an MRI on the NICU scanner.
11089162|NCT01522339|EG000|Reported Event|Pilot Group|Patients who had an MRI in the NICU scanner.
11089163|NCT01522391|BG000|Baseline|Placebo for DPK-060 Ointment|Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
11089164|NCT01522391|BG001|Baseline|DPK-060 1% Ointment|DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
11089165|NCT01522391|BG002|Baseline|Total|Total of all reporting groups
11089166|NCT01522391|FG000|Participant Flow|Placebo for DPK-060 Ointment|Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
11089167|NCT01522391|FG001|Participant Flow|DPK-060 1% Ointment|DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
11089168|NCT01522391|OG000|Outcome|Placebo for DPK-060 Ointment|Placebo for DPK-060 ointment: Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
11089169|NCT01522391|OG001|Outcome|DPK-060 1% Ointment|DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
11089170|NCT01522391|EG000|Reported Event|Placebo for DPK-060 Ointment|Placebo for DPK-060 ointment: Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
11089171|NCT01522391|EG001|Reported Event|DPK-060 1% Ointment|DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
11089172|NCT01522404|BG000|Baseline|Atomoxetine / Inactive Compound|Participants in this group are randomized to Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose during period 1/ Matching placebo that have inactive compound during period 2.
11089173|NCT01522404|BG001|Baseline|Inactive Compound / Atomoxetine|Participants in this group are randomized to matching placebo that have inactive compound during period 1/ Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose during period 2.
11089174|NCT01522404|BG002|Baseline|Total|Total of all reporting groups
11089175|NCT01522404|FG000|Participant Flow|Atomoxetine / Inactive Compound|Participants in this group are randomized to Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose during period 1/ Matching placebo that have inactive compound during period 2.
11089176|NCT01522404|FG001|Participant Flow|Inactive Compound / Atomoxetine|Participants in this group are randomized to matching placebo that have inactive compound during period 1/ Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose during period 2.
11089177|NCT01522404|OG000|Outcome|Atomoxetine / Inactive Compound|Participants in this group are randomized to Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose during period 1/ Matching placebo that have inactive compound during period 2.
11089178|NCT01522404|OG001|Outcome|Inactive Compound / Atomoxetine|Participants in this group are randomized to matching placebo that have inactive compound during period 1/ Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose during period 2.
11089179|NCT01522404|OG000|Outcome|Atomoxetine|Participants in this group received Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose.
11089180|NCT01522404|OG001|Outcome|Inactive Compound / Placebo|Participants in this group receive matching placebo that have inactive compound
11089181|NCT01522404|OG000|Outcome|Atomoxetine|Participants in this arm received Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose
11089182|NCT01522404|OG001|Outcome|Inactive Compound (Placebo)|Participants in this arm will receive a matching placebo that have inactive compound.
11089183|NCT01522404|OG000|Outcome|Atomoxetine|Participants in this group received Atomoxetine starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose.
11089184|NCT01522404|OG001|Outcome|Inactive Compound/Placebo|Participants in this group received Matching placebo that have inactive compound.
11089185|NCT01522404|OG000|Outcome|Atomoxetine / Inactive Compound|Participants in this arm received atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose for up to weeks 29 and are then crossed over to Inactive compound group
11089186|NCT01522404|OG001|Outcome|Inactive Compound / Atomoxetine|Subjects in this arm received a matching placebo that have inactive compound for up to weeks 29 and then are crossed over to receive active treatment of Atomoxetine
11089187|NCT01522404|EG000|Reported Event|Atomoxetine|Participants in this arm included all the participants that received Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose. The group includes 20 participants on Atomoxetine during period 1 and 19 participants on Atomoxetine during period 2.
11089188|NCT01522404|EG001|Reported Event|Inactive Compound|Participants in this arm included all the participants from both groups that received a matching placebo that have inactive compound. 19 participants on inactive compound during period 1 and 18 participants on inactive compound during period 2.
11089189|NCT01522417|BG000|Baseline|Short Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.~Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI."
11089190|NCT01522417|BG001|Baseline|Eptifibatide (Integrilin)|"Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.~Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first."
11089191|NCT01522417|BG002|Baseline|Long Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.~Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI."
11089192|NCT01522417|BG003|Baseline|Total|Total of all reporting groups
11155521|NCT01909804|FG007|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
11155522|NCT01909804|FG008|Participant Flow|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
11155523|NCT01909804|FG009|Participant Flow|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
11155524|NCT01909804|FG010|Participant Flow|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
11155525|NCT01909804|FG011|Participant Flow|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
11155526|NCT01909804|OG000|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
11155527|NCT01909804|OG001|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
11155528|NCT01909804|OG002|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
11155529|NCT01909804|OG003|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
11155530|NCT01909804|OG004|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
11155531|NCT01909804|OG005|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
11155532|NCT01909804|OG006|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
11155533|NCT01909804|OG007|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
11155534|NCT01909804|OG008|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
11155535|NCT01909804|OG009|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
11155536|NCT01909804|OG010|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
11155537|NCT01909804|OG011|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
11155538|NCT01909804|OG000|Outcome|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
11155539|NCT01909804|OG001|Outcome|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
11155540|NCT01909804|OG002|Outcome|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
11155541|NCT01909804|OG003|Outcome|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
11155542|NCT01909804|EG000|Reported Event|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
11155543|NCT01909804|EG001|Reported Event|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
11155544|NCT01909804|EG002|Reported Event|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
11155545|NCT01909804|EG003|Reported Event|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
11155546|NCT01909973|BG000|Baseline|MedLink System|"For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable pill bottle in order to provide and receive feedback regarding medication adherence.~MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
11155547|NCT01909973|BG001|Baseline|Treatment As Usual|Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
11155548|NCT01909973|BG002|Baseline|Total|Total of all reporting groups
11155549|NCT01909973|FG000|Participant Flow|MedLink System|"For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable pill bottle in order to provide and receive feedback regarding medication adherence.~MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
11155550|NCT01909973|FG001|Participant Flow|Treatment As Usual|Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
11155551|NCT01909973|OG000|Outcome|MedLink System|"For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable pill bottle in order to provide and receive feedback regarding medication adherence.~MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
11155552|NCT01909973|OG001|Outcome|Treatment As Usual|Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
11155553|NCT01909973|EG000|Reported Event|MedLink System|"For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable pill bottle in order to provide and receive feedback regarding medication adherence.~MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
11155554|NCT01909973|EG001|Reported Event|Treatment As Usual|Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
11155555|NCT01910064|BG000|Baseline|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
11155556|NCT01910064|FG000|Participant Flow|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
11155557|NCT01910064|OG000|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
11155558|NCT01910064|EG000|Reported Event|GK530G|GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
11155559|NCT01910116|BG000|Baseline|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
11155560|NCT01910116|BG001|Baseline|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
11155561|NCT01910116|BG002|Baseline|Total|Total of all reporting groups
11155562|NCT01910116|FG000|Participant Flow|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~Shinbaro"
11155563|NCT01910116|FG001|Participant Flow|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~Placebo"
11155564|NCT01910116|OG000|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
11155565|NCT01910116|OG001|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
11155566|NCT01910116|EG000|Reported Event|Shinbaro|"GCSB-5 (Shinbaro), 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
11155567|NCT01910116|EG001|Reported Event|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
11155568|NCT01910129|BG000|Baseline|gammaCore Then Sham gammaCore|"8 weeks Active gammaCore stimulation treatment followed by 8 weeks sham (inactive) gammaCore treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155569|NCT01910129|BG001|Baseline|Sham gammaCore Then gammaCore|"8 weeks sham (inactive) gammaCore treatment followed by 8 weeks active gammaCore treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155570|NCT01910129|BG002|Baseline|Total|Total of all reporting groups
11155571|NCT01910129|FG000|Participant Flow|gammaCore Then Sham gammaCore|"8 weeks active stimulation with the gammaCore device , no wash out , followed by 8 weeks sham treatment with the sham device~gammaCore/sham treatment: vagal verve stimulation 3 times a day 8 hours apart"
11155572|NCT01910129|FG001|Participant Flow|Sham gammaCore Then gammaCore|"8 weeks sham treatment with the sham device, no wash -out, followed by 8 weeks sham treatment with the with the gammaCore device~gammaCore/sham treatment: vagal verve stimulation 3 times a day 8 hours apart"
11155573|NCT01910129|FG002|Participant Flow|Run-in Period|Not randomized or allocated to treatment group
11155574|NCT01910129|OG000|Outcome|gammaCore Then Sham gammaCore|"Active gammaCore stimulation treatment followed by sham gammaCore treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155575|NCT01910129|OG001|Outcome|Sham gammaCore the gammaCore|"Inactive sham gammaCore stimulation treatment followed by Active gammaCore stimulation~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155576|NCT01910129|OG000|Outcome|gammaCore Then Sham gammaCore|"Active gammaCore stimulation treatment followed by inactive sham gammaCore treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155577|NCT01910129|OG001|Outcome|Sham gammaCore Then gammaCore|"Inactive sham gammaCore stimulation treatment followed by active gammaCore treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155578|NCT01910129|OG000|Outcome|gammaCore Then Sham gammaCore|"Active gammaCore stimulation treatment followed by inactive sham gammacore treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155579|NCT01910129|OG000|Outcome|Run-in Phase 1|No treatment - 4 week run-in phase
11155580|NCT01910129|OG001|Outcome|gammaCore Phase 2|"gammaCore stimulation treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155581|NCT01910129|OG002|Outcome|Sham Phase 2|"sham gammaCore stimulation treatment~sham stimulation 3 times a day 8 hours apart"
11155582|NCT01910129|OG003|Outcome|gammaCore Phase 3|"gammaCore stimulation treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155583|NCT01910129|OG004|Outcome|Sham Phase 3|"sham gammaCore stimulation treatment~sham stimulation 3 times a day 8 hours apart"
11155584|NCT01910129|OG000|Outcome|gammaCore Then Sham gammaCore|"Active gammacore stimulation treatment followed by inactive sham gammaCore treatment~gammaCore: vagal verve stimulation 3 times a day 8 hours apart"
11155585|NCT01910129|EG000|Reported Event|Run-in Phase 1|Not randomized or allocated to treatment group
11155586|NCT01910129|EG001|Reported Event|gammaCore Phase 2|"8 weeks gammaCore stimulation treatment~gammaCore vagal verve stimulation 3 times a day 8 hours apart"
11155587|NCT01910129|EG002|Reported Event|Sham Phase 2|"8 weeks sham stimulation treatment~sham stimulation 3 times a day 8 hours apart"
11155588|NCT01910129|EG003|Reported Event|gammaCore Phase 3|"8 weeks gammaCore stimulation treatment~gammaCore vagal verve stimulation 3 times a day 8 hours apart"
11155589|NCT01910129|EG004|Reported Event|Sham Phase 3|"8 weeks sham stimulation treatment~sham stimulation 3 times a day 8 hours apart"
11155590|NCT01910181|BG000|Baseline|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
11155591|NCT01910181|FG000|Participant Flow|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 milligrams (mg) twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The Pharmacokinetic (PK) Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
11155592|NCT01910181|OG000|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
11155593|NCT01910181|OG000|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
11155594|NCT01910181|EG000|Reported Event|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
11155595|NCT01910298|BG000|Baseline|Breast Reconstruction, Direct to Implant (DTI) With Strattice™|Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).
11155596|NCT01910298|BG001|Baseline|Two Stage Breast Reconstruction|Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant.
11155597|NCT01910298|BG002|Baseline|Total|Total of all reporting groups
11155598|NCT01910298|FG000|Participant Flow|Breast Reconstruction, Direct to Implant (DTI) With Strattice™|Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).
11155599|NCT01910298|FG001|Participant Flow|Two Stage Breast Reconstruction|Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant.
11155600|NCT01910298|OG000|Outcome|Breast Reconstruction, Direct to Implant (DTI) With Strattice™|Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).
11155601|NCT01910298|OG001|Outcome|Two Stage Breast Reconstruction|Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant.
11155602|NCT01910298|EG000|Reported Event|Breast Reconstruction, Direct to Implant (DTI) With Strattice™|Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).
11155603|NCT01910298|EG001|Reported Event|Two Stage Breast Reconstruction|Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant.
11155604|NCT01910311|BG000|Baseline|Baricitinib Then Baricitinib and Rifampicin|"Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10."
11155605|NCT01910311|FG000|Participant Flow|Baricitinib Then Baricitinib and Rifampicin|"Period 1: 10-milligram (mg) dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally once daily (QD) on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10."
11155606|NCT01910311|OG000|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
11155607|NCT01910311|OG001|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
11155608|NCT01910311|OG001|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with a coadministration of 10-mg dose of baricitinib on Day 10.
11155609|NCT01910311|EG000|Reported Event|Baricitinib|"A 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Adverse events (AEs) are reported from baseline through predose on Day 3."
11155610|NCT01910311|EG001|Reported Event|Rifampicin|"A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 9.~AEs are reported postdose on Day 3 through predose on Day 10."
11155611|NCT01910311|EG002|Reported Event|Baricitinib and Rifampicin|"A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 10 and 11, with coadministration of a 10-mg dose of baricitinib on Day 10.~AEs are reported postdose on Day 10 up to Day 32."
11155612|NCT01910519|BG000|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant|Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
11155613|NCT01910519|BG001|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv|Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
11155614|NCT01910519|BG002|Baseline|Total|Total of all reporting groups
11155615|NCT01910519|FG000|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant|Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
11155616|NCT01910519|FG001|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv|Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
11155617|NCT01910519|OG000|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant|Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
11155618|NCT01910519|OG001|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv|Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
11155619|NCT01910519|EG000|Reported Event|Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant|Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
11155620|NCT01910519|EG001|Reported Event|Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv|Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
11155621|NCT01910636|BG000|Baseline|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
11155622|NCT01910636|BG001|Baseline|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
11155623|NCT01910636|BG002|Baseline|Total|Total of all reporting groups
11155624|NCT01910636|FG000|Participant Flow|SOF+RBV Treatment Naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
11155625|NCT01910636|FG001|Participant Flow|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
11155626|NCT01910636|OG000|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
11155627|NCT01910636|OG001|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
11155628|NCT01910636|OG000|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
11155629|NCT01910636|EG000|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
11155630|NCT01910688|BG000|Baseline|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
11155631|NCT01910688|FG000|Participant Flow|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
11155632|NCT01910688|OG000|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
11155633|NCT01910688|EG000|Reported Event|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
11155634|NCT01910792|BG000|Baseline|Group 2|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
11155635|NCT01910792|BG001|Baseline|Group 1|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
11155636|NCT01910792|BG002|Baseline|Total|Total of all reporting groups
11155637|NCT01910792|FG000|Participant Flow|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
11155638|NCT01910792|FG001|Participant Flow|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
11155639|NCT01910792|OG000|Outcome|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
11155640|NCT01910792|OG001|Outcome|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
11155641|NCT01910792|EG000|Reported Event|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
11155642|NCT01910792|EG001|Reported Event|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
11155643|NCT01910831|BG000|Baseline|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
11155644|NCT01910831|FG000|Participant Flow|DerMend Moisturizing Bruise Formula vs. Vehicle Control|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula vs. Vehicle control."
11155645|NCT01910831|OG000|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula"
11155646|NCT01910831|OG001|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
11155647|NCT01910831|EG000|Reported Event|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
11155648|NCT01911065|BG000|Baseline|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
11155649|NCT01911065|BG001|Baseline|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
11155650|NCT01911065|BG002|Baseline|Total|Total of all reporting groups
11155651|NCT01911065|FG000|Participant Flow|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
11155652|NCT01911065|FG001|Participant Flow|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
11155653|NCT01911065|OG000|Outcome|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
11155654|NCT01911065|OG001|Outcome|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
11155655|NCT01911065|EG000|Reported Event|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
11155656|NCT01911065|EG001|Reported Event|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
11155657|NCT01911169|BG000|Baseline|Vitamin D 5000|"5,000 IU vitamin D (cholecalciferol) given orally daily~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
11155658|NCT01911169|BG001|Baseline|Vitamin D 400|"cholecalciferol 400 IU daily by mouth~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
11155659|NCT01911169|BG002|Baseline|Total|Total of all reporting groups
11155660|NCT01911169|FG000|Participant Flow|Vitamin D 5000|"5,000 IU vitamin D (cholecalciferol) given orally daily~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
11155661|NCT01911169|FG001|Participant Flow|Vitamin D 400|"cholecalciferol 400 IU daily by mouth~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
11155662|NCT01911169|OG000|Outcome|Repleted Vitamin D|Participants whose final serum 25(OH) vitamin D was > 32 ng/ml after 16 weeks of oral vitamin D
11155663|NCT01911169|OG001|Outcome|Not Repleted Vitamin D|Participants whose vitamin D therapy failed to replete final serum levels to > 32 ng/ml after 16 weeks of treatment
11155664|NCT01911169|EG000|Reported Event|Vitamin D 5000|"5,000 IU vitamin D (cholecalciferol) given orally daily~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
11155665|NCT01911169|EG001|Reported Event|Vitamin D 400|"cholecalciferol 400 IU daily by mouth~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
11155666|NCT01911221|BG000|Baseline|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
11155667|NCT01911221|FG000|Participant Flow|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
11155668|NCT01911221|OG000|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
11155669|NCT01911221|EG000|Reported Event|rMenB+OMVNZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
11155670|NCT01911260|BG000|Baseline|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155671|NCT01911260|BG001|Baseline|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155672|NCT01911260|BG002|Baseline|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155673|NCT01911260|BG003|Baseline|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155674|NCT01911260|BG004|Baseline|Total|Total of all reporting groups
11155675|NCT01911260|FG000|Participant Flow|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155676|NCT01911260|FG001|Participant Flow|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155677|NCT01911260|FG002|Participant Flow|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11228172|NCT02388633|OG000|Outcome|Plasmapharesis|"Patients undergoing apheresis for elevated LDL. Patients will undergo contrast ultrasound perfusion imaging at rest and during forearm exercise at before and immediately after apheresis.~Plasmapharesis: Clinically-indicated LDL apheresis"
11155678|NCT01911260|FG003|Participant Flow|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155679|NCT01911260|OG000|Outcome|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155680|NCT01911260|OG001|Outcome|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155681|NCT01911260|OG002|Outcome|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155682|NCT01911260|OG003|Outcome|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155683|NCT01911260|EG000|Reported Event|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155684|NCT01911260|EG001|Reported Event|Growth Deficit Receiving Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155685|NCT01911260|EG002|Reported Event|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
10887716|NCT00502593|FG002|Participant Flow|GSK1562902A-A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11155686|NCT01911260|EG003|Reported Event|Normal Height Receiving Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
11155687|NCT01911273|BG000|Baseline|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
11155688|NCT01911273|BG001|Baseline|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
11155689|NCT01911273|BG002|Baseline|Total|Total of all reporting groups
11155690|NCT01911273|FG000|Participant Flow|PF-03446962 Plus BSC|PF-03446962 7 milligram per kilogram (mg/kg) was administered intravenously (IV) as 1-hour infusion every two weeks (q2w) plus BSC
11155691|NCT01911273|FG001|Participant Flow|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
11155692|NCT01911273|OG000|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
11155693|NCT01911273|OG001|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
11155694|NCT01911273|EG000|Reported Event|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
11155695|NCT01911273|EG001|Reported Event|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
11155696|NCT01911351|BG000|Baseline|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
11155697|NCT01911351|BG001|Baseline|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
11155698|NCT01911351|BG002|Baseline|Total|Total of all reporting groups
11155699|NCT01911351|FG000|Participant Flow|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
11155700|NCT01911351|FG001|Participant Flow|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
11155701|NCT01911351|OG000|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
11155702|NCT01911351|OG001|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
11155703|NCT01911351|EG000|Reported Event|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
11155704|NCT01911351|EG001|Reported Event|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
11155705|NCT01911390|BG000|Baseline|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
11155706|NCT01911390|BG001|Baseline|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
11155707|NCT01911390|BG002|Baseline|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
11155708|NCT01911390|BG003|Baseline|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
11155709|NCT01911390|BG004|Baseline|Total|Total of all reporting groups
11155710|NCT01911390|FG000|Participant Flow|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
11155711|NCT01911390|FG001|Participant Flow|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
11155712|NCT01911390|FG002|Participant Flow|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
11155713|NCT01911390|FG003|Participant Flow|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
11155714|NCT01911390|OG000|Outcome|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
11155715|NCT01911390|OG001|Outcome|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
11155716|NCT01911390|OG002|Outcome|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
11155717|NCT01911390|OG003|Outcome|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
11155718|NCT01911390|EG000|Reported Event|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
11155719|NCT01911390|EG001|Reported Event|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
11155720|NCT01911390|EG002|Reported Event|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
11228173|NCT02388633|EG000|Reported Event|Plasmapharesis|"Patients undergoing apheresis for elevated LDL. Patients will undergo contrast ultrasound perfusion imaging at rest and during forearm exercise at before and immediately after apheresis.~Plasmapharesis: Clinically-indicated LDL apheresis"
11155721|NCT01911390|EG003|Reported Event|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
11155722|NCT01911403|BG000|Baseline|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
11155723|NCT01911403|BG001|Baseline|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
11155724|NCT01911403|BG002|Baseline|Total|Total of all reporting groups
11155725|NCT01911403|FG000|Participant Flow|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
11155726|NCT01911403|FG001|Participant Flow|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
11155727|NCT01911403|OG000|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
11155728|NCT01911403|OG001|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
11155729|NCT01911403|EG000|Reported Event|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
11155730|NCT01911403|EG001|Reported Event|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
11155731|NCT01911429|BG000|Baseline|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
11155732|NCT01911429|BG001|Baseline|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
11155733|NCT01911429|BG002|Baseline|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
11155734|NCT01911429|BG003|Baseline|Total|Total of all reporting groups
11155735|NCT01911429|FG000|Participant Flow|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
11155736|NCT01911429|FG001|Participant Flow|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit"
11155737|NCT01911429|FG002|Participant Flow|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
11155738|NCT01911429|OG000|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
11155739|NCT01911429|OG001|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
11155740|NCT01911429|OG002|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
11155741|NCT01911429|EG000|Reported Event|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
11155742|NCT01911429|EG001|Reported Event|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
11155743|NCT01911429|EG002|Reported Event|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
11155744|NCT01911442|BG000|Baseline|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
11155745|NCT01911442|BG001|Baseline|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
11155746|NCT01911442|BG002|Baseline|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
11155747|NCT01911442|BG003|Baseline|Total|Total of all reporting groups
11155748|NCT01911442|FG000|Participant Flow|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
11155749|NCT01911442|FG001|Participant Flow|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
11155750|NCT01911442|FG002|Participant Flow|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
11155751|NCT01911442|OG000|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
11155752|NCT01911442|OG001|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
11155753|NCT01911442|OG002|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
11155754|NCT01911442|OG000|Outcome|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
11155755|NCT01911442|OG000|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
11155756|NCT01911442|OG001|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily~Lurasidone: Lurasidone 60 mg once daily"
11155757|NCT01911442|OG002|Outcome|Placebo|"Placebo once daily~Placebo: Placebo"
11155758|NCT01911442|EG000|Reported Event|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
11155759|NCT01911442|EG001|Reported Event|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
11155760|NCT01911442|EG002|Reported Event|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
11155761|NCT01911546|BG000|Baseline|Everolimus + Low-dose Tacrolimus|"Patients receiving everolimus will be on low dose tacrolimus.~everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
11155762|NCT01911546|FG000|Participant Flow|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
11155763|NCT01911546|OG000|Outcome|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
11155764|NCT01911546|EG000|Reported Event|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
11155765|NCT01911689|BG000|Baseline|Acute Pancreatitis|All AP patients underwent the MRI scan within three days after admission. All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
11155766|NCT01911689|BG001|Baseline|Controlgroup|All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
11155767|NCT01911689|BG002|Baseline|Total|Total of all reporting groups
11155768|NCT01911689|FG000|Participant Flow|Acute Pancreatitis|acute pancreatitis group：(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination.
11155769|NCT01911689|FG001|Participant Flow|Controlgroup|normal control group：without pancreatic disorders.The exclusion criteria in this study were as follows: (a) inability to cooperate when MR imaging was performed; (b) a history of chronic pancreatitis; (c) AP due to pancreatic carcinoma; (d) hypoproteinemia; and (e) with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;(f) with iron deposition disorder (e.g. diabetes or blood system diseases).
11155770|NCT01911689|OG000|Outcome|Acute Pancreatitis|T2* value of AP group is mean T2* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP group:(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination
11155771|NCT01911689|OG001|Outcome|Control Group|T2* value of control group is mean T2* values of the head, body and tail of pancreas respectively.The control group:without pancreatic disorders
11155772|NCT01911689|OG000|Outcome|Edematous AP|T2* value of edematous AP
11155773|NCT01911689|OG001|Outcome|Necrotizing AP|T2* value of necrotizing AP
11155774|NCT01911689|OG000|Outcome|Mild AP|Mild AP was defined as 0-3 points according to MRSI.
11155775|NCT01911689|OG001|Outcome|Moderate AP|Moderate AP was defined as 4-6 points according to MRSI.
11155776|NCT01911689|OG002|Outcome|Severe AP|Severe AP was defined as 7-10 points according to MRSI.
11155777|NCT01911689|OG000|Outcome|Mild AP|Mild AP was graded as the Apache II score < 7 points.
11155778|NCT01911689|OG001|Outcome|Severe AP|Severe AP was graded as the Apache II score ≥8 points.
11155779|NCT01911689|EG000|Reported Event|Acute Pancreatitis|Not Including Serious
11155780|NCT01911689|EG001|Reported Event|Controlgroup|Not Including Serious
11155781|NCT01911780|BG000|Baseline|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
11155782|NCT01911780|BG001|Baseline|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
11155783|NCT01911780|BG002|Baseline|Total|Total of all reporting groups
11155784|NCT01911780|FG000|Participant Flow|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
11155785|NCT01911780|FG001|Participant Flow|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
11155786|NCT01911780|OG000|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
11155787|NCT01911780|OG001|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
11155788|NCT01911780|OG000|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
11155789|NCT01911780|OG001|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
11155790|NCT01911780|EG000|Reported Event|Telmisartan + HCTZ + Amlodipine - Double Blind Period|Telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks (double blind period)
11155791|NCT01911780|EG001|Reported Event|Telmisartan + HCTZ + Placebo - Double Blind Period|Telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks (double-blind period)
11155792|NCT01911780|EG002|Reported Event|Telmisartan + HCTZ + Amlodipine - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks in the double blind period. Adverse events which occurred in extension period were collected.
11155793|NCT01911780|EG003|Reported Event|Telmisartan + HCTZ + Placebo - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks in the double-blind period. Adverse events which occurred in extension period were collected.
11155794|NCT01911819|BG000|Baseline|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
11155795|NCT01911819|BG001|Baseline|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
11155796|NCT01911819|BG002|Baseline|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
11155797|NCT01911819|BG003|Baseline|Total|Total of all reporting groups
11155798|NCT01911819|FG000|Participant Flow|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
11155799|NCT01911819|FG001|Participant Flow|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
11155800|NCT01911819|FG002|Participant Flow|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
11155801|NCT01911819|OG000|Outcome|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
11155802|NCT01911819|OG001|Outcome|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
11155803|NCT01911819|OG002|Outcome|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
11155804|NCT01911819|EG000|Reported Event|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
11155805|NCT01911819|EG001|Reported Event|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
11155806|NCT01911819|EG002|Reported Event|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
11155807|NCT01911845|BG000|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
11155808|NCT01911845|FG000|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
11155809|NCT01911845|OG000|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
11155810|NCT01911845|OG000|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
11155811|NCT01911845|OG001|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
11155812|NCT01911845|EG000|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
11155813|NCT01911910|BG000|Baseline|Standard Care|Usual care that would be provided by the NHS Health Check or equivalent.
11155814|NCT01911910|BG001|Baseline|Electronic Coaching Plus Standard Care|"Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour.~Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour."
11228174|NCT02388646|BG000|Baseline|Exercise Only|"Home exercise program.~Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group."
11155815|NCT01911910|BG002|Baseline|Total|Total of all reporting groups
11155816|NCT01911910|FG000|Participant Flow|Standard Care|Usual care that would be provided by the NHS Health Check or equivalent.
11174306|NCT02020785|OG000|Outcome|Higher Phosphorus Period|"Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks~At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives.~Patients then randomized to higher phosphorus period or lower phosphorus period first.~Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) given for 3 weeks~Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks"
11228175|NCT02388646|BG001|Baseline|Brace Only|"Reaction Web brace.~Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living."
11155817|NCT01911910|FG001|Participant Flow|Electronic Coaching Plus Standard Care|"Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour.~Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour."
11155818|NCT01911910|OG000|Outcome|Standard Care|Usual care that would be provided by the NHS Health Check or equivalent.
11155819|NCT01911910|OG001|Outcome|Electronic Coaching Plus Standard Care|"Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour.~Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour."
11155820|NCT01911910|EG000|Reported Event|Standard Care|Usual care that would be provided by the NHS Health Check or equivalent.
11155821|NCT01911910|EG001|Reported Event|Electronic Coaching Plus Standard Care|"Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour.~Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour."
11155822|NCT01912222|BG000|Baseline|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
11155823|NCT01912222|BG001|Baseline|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
11155824|NCT01912222|BG002|Baseline|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
11155825|NCT01912222|BG003|Baseline|Total|Total of all reporting groups
11155826|NCT01912222|FG000|Participant Flow|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
11155827|NCT01912222|FG001|Participant Flow|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
11155828|NCT01912222|FG002|Participant Flow|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
11155829|NCT01912222|OG000|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
11155830|NCT01912222|OG001|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
11155831|NCT01912222|OG002|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
11155832|NCT01912222|OG000|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
11155833|NCT01912222|EG000|Reported Event|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
11155834|NCT01912222|EG001|Reported Event|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
11155835|NCT01912222|EG002|Reported Event|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
11155836|NCT01912274|BG000|Baseline|Pracinostat With Azacitadine|"60 mg of pracinostat by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days 75 mg/m2 azacitadine for the first 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous (IV) infusion if SC injections are intolerable~Pracinostat: Elderly newly diagnosed patients will all receive pracinostat~Azacitidine: Elderly newly diagnosed patients will all receive azacitadine"
11155837|NCT01912274|FG000|Participant Flow|Pracinostat With Azacitadine|"60 mg of pracinostat by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days 75 mg/m2 azacitadine for the first 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous (IV) infusion if SC injections are intolerable~Pracinostat: Elderly newly diagnosed patients will all receive pracinostat~Azacitidine: Elderly newly diagnosed patients will all receive azacitadine"
11155838|NCT01912274|OG000|Outcome|Pracinostat With Azacitadine|"60 mg of pracinostat by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days 75 mg/m2 azacitadine for the first 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous (IV) infusion if SC injections are intolerable~Pracinostat: Elderly newly diagnosed patients will all receive pracinostat~Azacitidine: Elderly newly diagnosed patients will all receive azacitadine"
11155839|NCT01912274|EG000|Reported Event|Pracinostat With Azacitadine|"60 mg of pracinostat by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days 75 mg/m2 azacitadine for the first 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous (IV) infusion if SC injections are intolerable~Pracinostat: Elderly newly diagnosed patients will all receive pracinostat~Azacitidine: Elderly newly diagnosed patients will all receive azacitadine"
11155840|NCT01912287|BG000|Baseline|Yoga|"The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.~Yoga: 12 sessions, mindfulness components"
11155841|NCT01912287|BG001|Baseline|Cognitive Behavioral Therapy (CBT)|"The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different lesson. These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts."
11155842|NCT01912287|BG002|Baseline|Stress Education|"SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.~Stress Education: Active control group (12 sessions)"
11155843|NCT01912287|BG003|Baseline|Total|Total of all reporting groups
11155844|NCT01912287|FG000|Participant Flow|Yoga|"The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.~Yoga: 12 sessions, mindfulness components"
11155845|NCT01912287|FG001|Participant Flow|Cognitive Behavioral Therapy (CBT)|"The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different lesson. These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts."
11155846|NCT01912287|FG002|Participant Flow|Stress Education|"SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.~Stress Education: Active control group (12 sessions)"
11228176|NCT02388646|BG002|Baseline|Bracing + Exercises|"Reaction Web brace and home exercises.~Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group."
11228177|NCT02388646|BG003|Baseline|Total|Total of all reporting groups
11155847|NCT01912287|OG000|Outcome|Yoga|"The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.~Yoga: 12 sessions, mindfulness components"
11155848|NCT01912287|OG001|Outcome|Cognitive Behavioral Therapy (CBT)|"The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different lesson. These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts."
11155849|NCT01912287|OG002|Outcome|Stress Education|"SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.~Stress Education: Active control group (12 sessions)"
11155850|NCT01912287|EG000|Reported Event|Yoga|"The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.~Yoga: 12 sessions, mindfulness components"
11155851|NCT01912287|EG001|Reported Event|Cognitive Behavioral Therapy (CBT)|"The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different lesson. These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts."
11155852|NCT01912287|EG002|Reported Event|Stress Education|"SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.~Stress Education: Active control group (12 sessions)"
11155853|NCT01912339|BG000|Baseline|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
11155854|NCT01912339|BG001|Baseline|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
11155855|NCT01912339|BG002|Baseline|Total|Total of all reporting groups
11155856|NCT01912339|FG000|Participant Flow|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
11155857|NCT01912339|FG001|Participant Flow|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
11155858|NCT01912339|FG002|Participant Flow|Crossover of Control Subjects|Subjects randomized to the control group will be offered the option to receive the Rezum treatment after the 3 month follow-up visit evaluations are completed. Subjects must decide to cross over by the end of the 6 month follow-up visit.
11155859|NCT01912339|OG000|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
11155860|NCT01912339|OG001|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
11155861|NCT01912339|EG000|Reported Event|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
11155862|NCT01912339|EG001|Reported Event|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
11155863|NCT01912352|BG000|Baseline|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
11155864|NCT01912352|FG000|Participant Flow|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
11155865|NCT01912352|OG000|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
11155866|NCT01912352|EG000|Reported Event|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
11155867|NCT01912456|BG000|Baseline|CSL830 (40)/Placebo High|
11155868|NCT01912456|BG001|Baseline|CSL830 (60)/Placebo Low|
11155869|NCT01912456|BG002|Baseline|Total|Total of all reporting groups
11155870|NCT01912456|FG000|Participant Flow|Placebo High/CSL830 (40)|High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
11155871|NCT01912456|FG001|Participant Flow|CSL830 (40)/Placebo High|A low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks, then a high-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks.
11155872|NCT01912456|FG002|Participant Flow|Placebo Low/CSL830 (60)|A low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks then a high-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
11155873|NCT01912456|FG003|Participant Flow|CSL830 (60)/Placebo Low|A high-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks.
11155874|NCT01912456|OG000|Outcome|CSL830 (40)|Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
11155875|NCT01912456|OG001|Outcome|CSL830 (60)|High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
11155876|NCT01912456|OG002|Outcome|Placebo High|High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
11155877|NCT01912456|OG003|Outcome|Placebo Low|Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
11155878|NCT01912456|EG000|Reported Event|CSL830 (40)|Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
11155879|NCT01912456|EG001|Reported Event|CSL830 (60)|High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
11155880|NCT01912456|EG002|Reported Event|Placebo High|High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
11155881|NCT01912456|EG003|Reported Event|Placebo Low|Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
11155882|NCT01912495|BG000|Baseline|Boceprevir/Peginterferon/Ribavirin|Boceprevir with Peginterferon and Ribavirin
11155883|NCT01912495|FG000|Participant Flow|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
11155884|NCT01912495|OG000|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
11155885|NCT01912495|OG000|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
11155886|NCT01912495|OG000|Outcome|Boceprevir Peginterferon Ribavirin|12 week Boceprevir peginterferon and ribavirin
11155887|NCT01912495|OG000|Outcome|Boceprevir Peginterferon Ribavirin|Boceprevir peginterferon and ribavirin
11155888|NCT01912495|EG000|Reported Event|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
11155889|NCT01912599|BG000|Baseline|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
11155890|NCT01912599|BG001|Baseline|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
11155891|NCT01912599|BG002|Baseline|Total|Total of all reporting groups
11155892|NCT01912599|FG000|Participant Flow|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
11155893|NCT01912599|FG001|Participant Flow|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
11155894|NCT01912599|OG000|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
11155895|NCT01912599|OG001|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
11155896|NCT01912599|EG000|Reported Event|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
11228178|NCT02388646|FG000|Participant Flow|Exercise Only|"Home exercise program.~Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group."
11228179|NCT02388646|FG001|Participant Flow|Brace Only|"Reaction Web brace.~Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living."
11155897|NCT01912599|EG001|Reported Event|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
11155898|NCT01912612|BG000|Baseline|Arm 1 (Patients With Pain)|"Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.~Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days."
11155899|NCT01912612|BG001|Baseline|Arm 2 (Patients Without Pain -- Control)|Patient reported pain and symptoms assessment for comparison at baseline.
11155900|NCT01912612|BG002|Baseline|Total|Total of all reporting groups
11155901|NCT01912612|FG000|Participant Flow|Arm 1 (Patients With Pain)|"Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.~Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.~Surveys administered at baseline and at 5 weeks."
11155902|NCT01912612|FG001|Participant Flow|Arm 2 (Patients Without Pain -- Control)|Surveys administered at baseline only.
11155903|NCT01912612|FG002|Participant Flow|Arm 3 - Placebo (Withdrawn)|Because of challenges with logistics of the protocol and pain testing, the trial was redesigned after only 7 patients with pain were enrolled. Three of the patients had been assigned to placebo arm. This arm is not included in any analysis.
11155904|NCT01912612|OG000|Outcome|Arm 1 (Patients With Pain)|"Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.~Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days."
11155905|NCT01912612|OG001|Outcome|Arm 2 (Patients Without Pain -- Control)|Patient reported pain and symptoms assessment for comparison at baseline.
11155906|NCT01912612|EG000|Reported Event|Arm 1 (Patients With Pain)|"Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.~Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days."
11155907|NCT01912612|EG001|Reported Event|Arm 2 (Patients Without Pain -- Control)|Patient reported pain and symptoms assessment for comparison at baseline.
11155908|NCT01912716|BG000|Baseline|Standard Dose Group|Participants randomized to this group receive 100 mg indomethacin
11155909|NCT01912716|BG001|Baseline|High Dose Group|Participants randomized to this group receive 200 mg indomethacin
11155910|NCT01912716|BG002|Baseline|Total|Total of all reporting groups
11155911|NCT01912716|FG000|Participant Flow|High-dose Indomethacin|"200mg rectal indomethacin~high dose indomethacin"
11155912|NCT01912716|FG001|Participant Flow|Standard Dose Indomethacin|"100mg rectal indomethacin~standard dose"
11155913|NCT01912716|OG000|Outcome|Standard 100mg Dose|patients receiving 100mg indomethacin
11155914|NCT01912716|OG001|Outcome|High Dose 200 mg|patients receiving 200mg indomethacin
11155915|NCT01912716|OG000|Outcome|Standard Dose 100 mg|patients receiving 100mg indomethacin
11155916|NCT01912716|OG001|Outcome|High Dose 200mg|patients receiving 200mg indomethacin
11155917|NCT01912716|EG000|Reported Event|Standard-dose Indomethacin|"100mg rectal indomethacin~standard dose indomethacin"
11155918|NCT01912716|EG001|Reported Event|High-dose Indomethacin|"200mg rectal indomethacin~high-dose dose"
11155919|NCT01912729|BG000|Baseline|Arm 1 - Networked Peer Support With Peer Guide|"Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.~Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants."
11155920|NCT01912729|BG001|Baseline|Arm 2 - Networked Peer Support With Clinician Coach|"Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.~Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist."
11155921|NCT01912729|BG002|Baseline|Total|Total of all reporting groups
11155922|NCT01912729|FG000|Participant Flow|Networked Peer Support With Peer Guide|"Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.~Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants."
11233845|NCT02431273|EG001|Reported Event|TDF-FTC (Dual IVR)|"If the TDF IVR is determined as safe, study participants will be asked to replace it with Dual (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.~TDF-FTC IVR"
11155923|NCT01912729|FG001|Participant Flow|Networked Peer Support With Clinician Coach|"Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.~Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist."
11155924|NCT01912729|OG000|Outcome|Arm 1 - Networked Peer Support With Peer Guide|"Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.~Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants."
11155925|NCT01912729|OG001|Outcome|Arm 2 - Networked Peer Support With Clinician Coach|"Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.~Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist."
11155926|NCT01912729|EG000|Reported Event|Arm 1 - Networked Peer Support With Peer Guide|"Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.~Networked Peer Support with Peer Guide: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants."
11155927|NCT01912729|EG001|Reported Event|Arm 2 - Networked Peer Support With Clinician Coach|"Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.~Networked Peer Support with Clinician Coach: Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist."
11155928|NCT01912768|BG000|Baseline|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
11155929|NCT01912768|BG001|Baseline|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
11155930|NCT01912768|BG002|Baseline|Total|Total of all reporting groups
11155931|NCT01912768|FG000|Participant Flow|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
11155932|NCT01912768|FG001|Participant Flow|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
11155933|NCT01912768|OG000|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
11155934|NCT01912768|OG001|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
11155935|NCT01912768|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
11155936|NCT01912768|EG001|Reported Event|FID 120947A|All subjects who were exposed to FID 120947A
11155937|NCT01912768|EG002|Reported Event|Renu Fresh|All subjects who were exposed to renu fresh
11155938|NCT01912781|BG000|Baseline|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
11155939|NCT01912781|BG001|Baseline|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
11155940|NCT01912781|BG002|Baseline|Total|Total of all reporting groups
11155941|NCT01912781|FG000|Participant Flow|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
11155942|NCT01912781|FG001|Participant Flow|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
11155943|NCT01912781|OG000|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
11155944|NCT01912781|OG001|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
11155945|NCT01912781|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
11155946|NCT01912781|EG001|Reported Event|FID 120974A|All subjects who were exposed to FID 120947A
11155947|NCT01912781|EG002|Reported Event|Boston Simplus|All subjects who were exposed to Boston Simplus
11228180|NCT02388646|FG002|Participant Flow|Bracing + Exercises|"Reaction Web brace and home exercises.~Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group."
11155948|NCT01912807|BG000|Baseline|Dextrose (D5NS) - Intervention Group|"The participants received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis and Dextrose 5% in 0.9 % Normal Saline (D5NS) was used as a second antiemetic, at an intravenous rate calculated based on their weight and determined for the purpose of the study.~Dextrose (D5NS): Solution Dextrose 5% in Normal Saline (D5NS) was used as a second antiemetic, at an intravenous maintenace rate (4 cc per Kg for first 10 Kg, 2 cc per Kg for next 10 Kg and 1 cc per Kg for the next Kg of weight) calculated based on the patient's weight"
11155949|NCT01912807|BG001|Baseline|Ondansetron - Control Group|"The control group received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis. Ondansetron (dose 0,05 mg/Kg) was used as a second prophylactic antiemetic.~Ondansetron (Control): Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight."
11155950|NCT01912807|BG002|Baseline|Total|Total of all reporting groups
11155951|NCT01912807|FG000|Participant Flow|Dextrose (D5NS) - Intervention Group|"The participants received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis and Dextrose 5% in 0.9 % Normal Saline (D5NS) was used as a second antiemetic, at an intravenous rate calculated based on their weight and determined for the purpose of the study.~Dextrose (D5NS): Solution Dextrose 5% in Normal Saline (D5NS) was used as a second antiemetic, at an intravenous maintenace rate (4 cc per Kg for first 10 Kg, 2 cc per Kg for next 10 Kg and 1 cc per Kg for the next Kg of weight) calculated based on the patient's weight"
11155952|NCT01912807|FG001|Participant Flow|Ondansetron - Control Group|"The control group received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis. Ondansetron (dose 0,05 mg/Kg) was used as a second prophylactic antiemetic.~Ondansetron (Control): Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight."
11155953|NCT01912807|OG000|Outcome|Dextrose (D5NS) - Intervention Group|"The participants received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis and Dextrose 5% in 0.9 % Normal Saline (D5NS) was used as a second antiemetic, at an intravenous rate calculated based on their weight and determined for the purpose of the study.~Dextrose (D5NS): Solution Dextrose 5% in Normal Saline (D5NS) was used as a second antiemetic, at an intravenous maintenace rate (4 cc per Kg for first 10 Kg, 2 cc per Kg for next 10 Kg and 1 cc per Kg for the next Kg of weight) calculated based on the patient's weight"
11155954|NCT01912807|OG001|Outcome|Ondansetron - Control Group|"The control group received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis. Ondansetron (dose 0,05 mg/Kg) was used as a second prophylactic antiemetic.~Ondansetron (Control): Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight."
11155955|NCT01912807|EG000|Reported Event|Dextrose (D5NS) - Intervention Group|"The participants received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis and Dextrose 5% in 0.9 % Normal Saline (D5NS) was used as a second antiemetic, at an intravenous rate calculated based on their weight and determined for the purpose of the study.~Dextrose (D5NS): Solution Dextrose 5% in Normal Saline (D5NS) was used as a second antiemetic, at an intravenous maintenace rate (4 cc per Kg for first 10 Kg, 2 cc per Kg for next 10 Kg and 1 cc per Kg for the next Kg of weight) calculated based on the patient's weight"
11155956|NCT01912807|EG001|Reported Event|Ondansetron - Control Group|"The control group received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis. Ondansetron (dose 0,05 mg/Kg) was used as a second prophylactic antiemetic.~Ondansetron (Control): Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight."
11155957|NCT01912872|BG000|Baseline|Pediatric Patients: Omalizumab + Budesonide and Formoterol|Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
11155958|NCT01912872|BG001|Baseline|Pediatric Patients: Budesonide and Formoterol|Participants received budesonide + formoterol administered through an inhaler device.
11155959|NCT01912872|BG002|Baseline|Adult Patients: Omalizumab + Budesonide and Formoterol|Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
11155960|NCT01912872|BG003|Baseline|Adult Patients: Budesonide and Formoterol|Participants receive budesonide + formoterol administered through an inhaler device.
11155961|NCT01912872|BG004|Baseline|Total|Total of all reporting groups
11155962|NCT01912872|FG000|Participant Flow|Pediatric Patients: Omalizumab + Budesonide and Formoterol|Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
11155963|NCT01912872|FG001|Participant Flow|Pediatric Patients: Budesonide and Formoterol|Participants received budesonide + formoterol administered through an inhaler device.
11155964|NCT01912872|FG002|Participant Flow|Adult Patients: Omalizumab + Budesonide and Formoterol|Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
11155965|NCT01912872|FG003|Participant Flow|Adult Patients: Budesonide and Formoterol|Participants receive budesonide + formoterol administered through an inhaler device.
11155966|NCT01912872|OG000|Outcome|Pediatric Patients: Omalizumab + Budesonide and Formoterol|Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
11155967|NCT01912872|OG001|Outcome|Pediatric Patients: Budesonide and Formoterol|Participants received budesonide + formoterol administered through an inhaler device.
11155968|NCT01912872|OG002|Outcome|Adult Patients: Omalizumab + Budesonide and Formoterol|Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
11155969|NCT01912872|OG003|Outcome|Adult Patients: Budesonide and Formoterol|Participants receive budesonide + formoterol administered through an inhaler device.
11155970|NCT01912872|OG003|Outcome|Adult Patients: Budesonide and Formoterol|Participants received budesonide + formoterol administered through an inhaler device.
11155971|NCT01912872|EG000|Reported Event|Pediatric Patients: Omalizumab + Budesonide and Formoterol|Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
11155972|NCT01912872|EG001|Reported Event|Pediatric Patients: Budesonide and Formoterol|Participants received budesonide + formoterol administered through an inhaler device.
11155973|NCT01912872|EG002|Reported Event|Adult Patients: Omalizumab + Budesonide and Formoterol|Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
11155974|NCT01912872|EG003|Reported Event|Adult Patients: Budesonide and Formoterol|Participants receive budesonide + formoterol administered through an inhaler device.
11155975|NCT01912963|BG000|Baseline|Phase I: Dose Level 1 (D1)|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (D1)~Cycle duration=21 days~The Phase I run-in potentially evaluates 2 dose levels of eribulin in combination with pertuzumab and trastuzumab. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155976|NCT01912963|BG001|Baseline|Phase II Cohort A: Without Prior Pertuzumab Exposure|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (recommended phase II dose)~Cycle duration=21 days~In the Phase II study, participants enrolled into two possible cohorts based on prior pertuzumab exposure. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155977|NCT01912963|BG002|Baseline|Phase II Cohort B: With Prior Pertuzumab Exposure|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (recommended phase II dose)~Cycle duration=21 days~In the Phase II study, participants enrolled into two possible cohorts based on prior pertuzumab exposure. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase.~Pertuzumab~Trastuzumab~eribulin"
11155978|NCT01912963|BG003|Baseline|Total|Total of all reporting groups
11155979|NCT01912963|FG000|Participant Flow|Phase I: Dose Level 1 (D1)|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (D1)~Cycle duration=21 days~The Phase I run-in potentially evaluates 2 dose levels of eribulin in combination with pertuzumab and trastuzumab. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155980|NCT01912963|FG001|Participant Flow|Phase II Cohort A: Without Prior Pertuzumab Exposure|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (recommended phase II dose)~Cycle duration=21 days~In the Phase II study, participants enrolled into two possible cohorts based on prior pertuzumab exposure. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155981|NCT01912963|FG002|Participant Flow|Phase II Cohort B: With Prior Pertuzumab Exposure|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (recommended phase II dose)~Cycle duration=21 days~In the Phase II study, participants enrolled into two possible cohorts based on prior pertuzumab exposure. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase.~Pertuzumab~Trastuzumab~eribulin"
11155982|NCT01912963|OG000|Outcome|Phase I: Pertuzumab, Trastuzumab and Eribulin Dose Level 1 (D1|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (D1)~Cycle duration=21 days~The Phase I run-in potentially evaluates 2 dose levels of eribulin in combination with pertuzumab and trastuzumab. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155983|NCT01912963|OG000|Outcome|Phase II Cohort A: Without Prior Pertuzumab Exposure|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (recommended phase II dose)~Cycle duration=21 days~In the Phase II study, participants enrolled into two possible cohorts based on prior pertuzumab exposure. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11228181|NCT02388646|OG000|Outcome|Exercise Only|"Home exercise program.~Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group."
11228182|NCT02388646|OG001|Outcome|Brace Only|"Reaction Web brace.~Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living."
11155984|NCT01912963|OG001|Outcome|Phase II Cohort B: With Prior Pertuzumab Exposure|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (recommended phase II dose)~Cycle duration=21 days~In the Phase II study, participants enrolled into two possible cohorts based on prior pertuzumab exposure. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155985|NCT01912963|EG000|Reported Event|Phase I: Dose Level 1 (D1)|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (D1)~Cycle duration=21 days~The Phase I run-in potentially evaluates 2 dose levels of eribulin in combination with pertuzumab and trastuzumab. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155986|NCT01912963|EG001|Reported Event|Phase II Cohort A: Without Prior Pertuzumab Exposure|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (recommended phase II dose)~Cycle duration=21 days~In the Phase II study, participants enrolled into two possible cohorts based on prior pertuzumab exposure. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155987|NCT01912963|EG002|Reported Event|Phase II Cohort B: With Prior Pertuzumab Exposure|"Pertuzumab: 840 mg/cycle 1 then 420 mg/cycle IV on day 1~Trastuzumab: 8 mg/kg/cycle 1 then 6 mg/kg cycle IV on day 1~Eribulin: 1.4 mg/m2/cycle IV on days 1 and 8 (recommended phase II dose)~Cycle duration=21 days~In the Phase II study, participants enrolled into two possible cohorts based on prior pertuzumab exposure. Participants first receive antibody administration then eribulin. In the treatment phase, participants receive up to 6 cycles of combination therapy unless disease progression (PD) or withdrawal for other reasons (w/d). Participants who complete 6 cycles have the option to continue with antibody therapy only until PD or w/d in the extension phase."
11155988|NCT01913041|BG000|Baseline|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
11155989|NCT01913041|FG000|Participant Flow|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
11155990|NCT01913041|OG000|Outcome|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
11155991|NCT01913041|EG000|Reported Event|Observation Group|There is only one group, The main purpose of this investigation is to observe the hypothermia rate in elective operations under general anaesthesia in Peking in China.
11155992|NCT01913314|BG000|Baseline|[^14C]-LY2835219|Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
11155993|NCT01913314|FG000|Participant Flow|[^14C]-LY2835219|Single 150-milligram (mg) LY2835219 dose containing 5 micro- curies (µCi) of carbon-14-labeled LY2835219 ([^14C]-LY2835219), administered as an oral solution.
11155994|NCT01913314|OG000|Outcome|[^14C]-LY2835219|Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
11155995|NCT01913314|EG000|Reported Event|[^14C]-LY2835219|Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
11155996|NCT01913340|BG000|Baseline|Erythropoietin|Erythropoietin: 1000 U/kg/dose IV x 5 doses
11155997|NCT01913340|BG001|Baseline|Normal Saline|Normal saline: placebo: NS IV x 5 doses
11155998|NCT01913340|BG002|Baseline|Total|Total of all reporting groups
11155999|NCT01913340|FG000|Participant Flow|Erythropoietin|"1000 U/kg/dose x 5 doses~Erythropoietin: 1000 U/kg/dose IV x 5 doses"
11156000|NCT01913340|FG001|Participant Flow|Normal Saline|Normal saline: placebo: NS IV x 5 doses
11156001|NCT01913340|OG000|Outcome|Erythropoietin|Erythropoietin: 1000 U/kg/dose IV x 5 doses
11156002|NCT01913340|OG001|Outcome|Normal Saline|Normal saline: placebo: NS IV x 5 doses
11156003|NCT01913340|EG000|Reported Event|Erythropoietin - Infants|Erythropoietin: 1000 U/kg/dose IV x 5 doses
11156004|NCT01913340|EG001|Reported Event|Normal Saline - Infants|Normal saline: placebo: NS IV x 5 doses
11156005|NCT01913353|BG000|Baseline|Group 1|"Two vaccinations; MVA BN ®; administered 4 weeks apart (Day 0 and Day 28) followed by a single vaccination of ACAM2000® vaccine 4 weeks after the second MVA BN® vaccination (Day 56).~MVA BN®: 0.5 ml MVA BN® with a nominal titre of 1x10E8 TCID50, administered as a subcutaneous injection~ACAM2000®: 0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle."
11156006|NCT01913353|BG001|Baseline|Group 2|"A single vaccination of ACAM2000® will be administered at Day 0.~ACAM2000®: 0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle."
11156007|NCT01913353|BG002|Baseline|Total|Total of all reporting groups
10887717|NCT00502593|FG003|Participant Flow|Fluarix-A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11156008|NCT01913353|FG000|Participant Flow|Group 1|"Two vaccinations; MVA BN ®; administered 4 weeks apart (Day 0 and Day 28) followed by a single vaccination of ACAM2000® vaccine 4 weeks after the second MVA BN® vaccination (Day 56).~MVA BN®: 0.5 ml MVA BN® with a nominal titer of 1x10E8 TCID50, administered as a subcutaneous injection~ACAM2000®: 0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle."
11156009|NCT01913353|FG001|Participant Flow|Group 2|"A single vaccination of ACAM2000® will be administered at Day 0.~ACAM2000®: 0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle."
11156010|NCT01913353|OG000|Outcome|Group 1|"Two vaccinations; MVA-BN ®; administered 4 weeks apart (Day 0 and Day 28) followed by a single vaccination of ACAM2000® vaccine 4 weeks after the second MVA-BN® vaccination (Day 56).~MVA-BN®: 0.5 ml MVA-BN® with a nominal titer of 1x10E8 TCID50, administered as a subcutaneous injection~ACAM2000®: 0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle."
11156011|NCT01913353|OG001|Outcome|Group 2|"A single vaccination of ACAM2000® will be administered at Day 0.~ACAM2000®: 0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle."
11156012|NCT01913353|OG000|Outcome|Group 1, Period 1|after 1st dose of MVA-BN
11156013|NCT01913353|OG001|Outcome|Group 1, Period 2|after second dose of MVA-BN
11156014|NCT01913353|OG002|Outcome|Group 1, Period 3|after ACAM2000
11156015|NCT01913353|OG003|Outcome|Group 2|ACAM2000
10887718|NCT00502593|FG004|Participant Flow|GSK1562902A-B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887719|NCT00502593|FG005|Participant Flow|Fluarix-B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887720|NCT00502593|FG006|Participant Flow|GSK1562902A-B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11156016|NCT01913353|OG001|Outcome|Group 1, Period 2|after 2nd dose of MVA-BN
11156017|NCT01913353|EG000|Reported Event|Group 1, Period 1|after 1st dose of MVA-BN
11156018|NCT01913353|EG001|Reported Event|Group 1, Period 2|after 2nd dose of MVA-BN
11156019|NCT01913353|EG002|Reported Event|Group 1, Period 3|after ACAM2000
11156020|NCT01913353|EG003|Reported Event|Group 2|ACAM2000
11156021|NCT01913405|BG000|Baseline|BAX855|Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed.
11228183|NCT02388646|OG002|Outcome|Bracing + Exercises|"Reaction Web brace and home exercises.~Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group."
10887721|NCT00502593|FG007|Participant Flow|Fluarix-B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887722|NCT00502593|FG008|Participant Flow|GSK1562902A-C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887723|NCT00502593|FG009|Participant Flow|Fluarix-C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887724|NCT00502593|FG010|Participant Flow|GSK1562902A-C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887725|NCT00502593|FG011|Participant Flow|Fluarix-C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887726|NCT00502593|OG000|Outcome|GSK1562902A-A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887727|NCT00502593|OG001|Outcome|Fluarix-A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887728|NCT00502593|OG002|Outcome|GSK1562902A-A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887729|NCT00502593|OG003|Outcome|Fluarix-A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887730|NCT00502593|OG004|Outcome|GSK1562902A-B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887731|NCT00502593|OG005|Outcome|Fluarix-B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887732|NCT00502593|OG006|Outcome|GSK1562902A-B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887733|NCT00502593|OG007|Outcome|Fluarix-B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887734|NCT00502593|OG008|Outcome|GSK1562902A-C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887735|NCT00502593|OG009|Outcome|Fluarix-C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11156022|NCT01913405|FG000|Participant Flow|BAX855|Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed.
11156023|NCT01913405|OG000|Outcome|Full Analysis Group|All participants treated with BAX855 with available GHEA score.
11156024|NCT01913405|OG001|Outcome|Major Orthopedic Surgery|All participants treated with BAX855 for major orthopedic surgery.
11156025|NCT01913405|OG002|Outcome|Major Non-orthopedic Surgery|All participants treated with BAX855 for major non-orthopedic surgery.
11156026|NCT01913405|OG003|Outcome|Minor Surgery|All participants treated with BAX855 for minor surgery.
11156027|NCT01913405|OG004|Outcome|Per Protocol Analysis Group|All participants treated with BAX855 with all 3 hemostatic efficacy assessments available. Only subjects who met all study entry criteria and who had no major protocol violation that impacted hemostatic efficacy assessment were included in this group.
11156028|NCT01913405|OG000|Outcome|Full Analysis Group|All participants treated with BAX855 with at least one available hemostatic assessment.
11156029|NCT01913405|OG000|Outcome|Pharmacokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
11156030|NCT01913405|OG000|Outcome|Pharmocokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
10887736|NCT00502593|OG010|Outcome|GSK1562902A-C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11156031|NCT01913405|OG000|Outcome|BAX855|Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed.
11156032|NCT01913405|OG000|Outcome|Hemoglobin: Abnormal Ncs at Screening - Abnormal cs at EOS|Hematology: The hemoglobin result was abnormal not clinically significant at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
11156033|NCT01913405|OG001|Outcome|Hematocrit: Abnormal Ncs at Screening - Abnormal cs at EOS|Hematology: The hematocrit result was abnormal not clinically significant at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
11156034|NCT01913405|OG002|Outcome|Erythrocytes: Normal at Screening - Abnormal cs at EOS|Hematology: The Erythrocytes result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
11156035|NCT01913405|OG003|Outcome|Eosinophils/Leucocytes: Normal at Screening Abnormal cs at EOS|Hematology: The Eosinophils/Leucocytes result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
11156036|NCT01913405|OG004|Outcome|ALT: Normal at Screening - Abnormal cs at EOS|Chemistry: The ALT result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
11156037|NCT01913405|EG000|Reported Event|BAX855|Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed.
11156038|NCT01913470|BG000|Baseline|Losartan Followed by Placebo|Recipients of treatment with losartan for 8 weeks followed by 8 weeks of treatment with a placebo.
11156039|NCT01913470|BG001|Baseline|Placebo Followed by Losartan|Recipients of treatment with a placebo for 8 weeks followed by 8 weeks of treatment with losartan.
11156040|NCT01913470|BG002|Baseline|Total|Total of all reporting groups
11156041|NCT01913470|FG000|Participant Flow|Losartan Followed by Placebo|Recipients of treatment with losartan for 8 weeks followed by 8 weeks of treatment with a placebo
11156042|NCT01913470|FG001|Participant Flow|Placebo Followed by Losartan|Recipients of treatment with a placebo for 8 weeks followed by 8 weeks of treatment with losartan.
11156043|NCT01913470|OG000|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
11156044|NCT01913470|OG001|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
11156045|NCT01913470|OG001|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks
11156046|NCT01913470|EG000|Reported Event|Losartan|Recipients of treatment with losartan for 8 weeks.
11156047|NCT01913470|EG001|Reported Event|Placebo|Recipients of treatment with a placebo for 8 weeks.
11156048|NCT01913483|BG000|Baseline|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
11156049|NCT01913483|BG001|Baseline|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
11156050|NCT01913483|BG002|Baseline|Total|Total of all reporting groups
11156051|NCT01913483|FG000|Participant Flow|Bivalirudin|Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters per minute [mL/min]).
11156052|NCT01913483|FG001|Participant Flow|Unfractionated Heparin|Unfractionated heparin (UFH) was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
11156053|NCT01913483|OG000|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
11156054|NCT01913483|OG001|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
11156055|NCT01913483|EG000|Reported Event|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
11156056|NCT01913483|EG001|Reported Event|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
11156057|NCT01913535|BG000|Baseline|Low Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
11156058|NCT01913535|BG001|Baseline|High Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
11156059|NCT01913535|BG002|Baseline|Placebo/Low-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)~CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
11156060|NCT01913535|BG003|Baseline|Placebo/High-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)~CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
11156061|NCT01913535|BG004|Baseline|Placebo/Placebo Arm|Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
11156062|NCT01913535|BG005|Baseline|Total|Total of all reporting groups
11156063|NCT01913535|FG000|Participant Flow|Low Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
11156064|NCT01913535|FG001|Participant Flow|High Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
11156065|NCT01913535|FG002|Participant Flow|Placebo/Low-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)~CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days."
11156066|NCT01913535|FG003|Participant Flow|Placebo/High-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)~CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
11156067|NCT01913535|FG004|Participant Flow|Placebo/Placebo Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~Placebo: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days)."
11156068|NCT01913535|OG000|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
11156069|NCT01913535|OG001|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
11156070|NCT01913535|OG000|Outcome|CERC-501|either dose (10 mg/day or 20 mg/day) of CERC-501 in drug-drug arms
11156071|NCT01913535|OG001|Outcome|Placebo|Placebo therapy in placebo-placebo arm
11156072|NCT01913535|OG000|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: either dose drug-drug arms only"
11156073|NCT01913535|OG001|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: placebo-placebo arm only"
11156074|NCT01913535|OG000|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
11156075|NCT01913535|OG001|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
11156076|NCT01913535|EG000|Reported Event|Low Dose Drug|Patients receive CERC-501 10.0 mg/day
11156077|NCT01913535|EG001|Reported Event|High Dose Drug|Patients receive CERC-501 20.0 mg/day
11156078|NCT01913535|EG002|Reported Event|Placebo|Patients receive placebo
11156079|NCT01913600|BG000|Baseline|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
11156080|NCT01913600|FG000|Participant Flow|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
11156081|NCT01913600|OG000|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
11156082|NCT01913600|EG000|Reported Event|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
11156083|NCT01913639|BG000|Baseline|FOLFOX Plus Regorafenib|Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.
11228184|NCT02388646|EG000|Reported Event|Exercise Only|"Home exercise program.~Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group."
11228185|NCT02388646|EG001|Reported Event|Brace Only|"Reaction Web brace.~Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living."
11156084|NCT01913639|FG000|Participant Flow|FOLFOX Plus Regorafenib|Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.
11156085|NCT01913639|OG000|Outcome|FOLFOX Plus Regorafenib|Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.
11156086|NCT01913639|EG000|Reported Event|FOLFOX Plus Regorafenib|Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.
11156087|NCT01914003|BG000|Baseline|CSID Mutations|Individual has one or more known CSID mutations.
11156088|NCT01914003|BG001|Baseline|Control|Individual does not have any known CSID mutations.
11156089|NCT01914003|BG002|Baseline|Total|Total of all reporting groups
11156090|NCT01914003|FG000|Participant Flow|CSID Mutations|Individual has one or more known CSID mutations.
11156091|NCT01914003|FG001|Participant Flow|Control|Individual does not have any known CSID mutations.
11156092|NCT01914003|OG000|Outcome|CSID Mutations|Individual has one or more known CSID mutations.
11156093|NCT01914003|OG001|Outcome|Control|Individual does not have any known CSID mutations.
11156094|NCT01914003|EG000|Reported Event|CSID Mutations|Individual has one or more known CSID mutations.
11156095|NCT01914003|EG001|Reported Event|Control|Individual does not have any known CSID mutations.
11156096|NCT01914159|BG000|Baseline|Ranibizumab|Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
11156097|NCT01914159|FG000|Participant Flow|Ranibizumab|Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
11156098|NCT01914159|OG000|Outcome|Ranibizumab|Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
11156099|NCT01914159|EG000|Reported Event|Ranibizumab|Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
11156100|NCT01914393|BG000|Baseline|Rollover From D1050301|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
11156101|NCT01914393|BG001|Baseline|Rollover From D1050325|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
11156102|NCT01914393|BG002|Baseline|Rollover From D1050326|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
11156103|NCT01914393|BG003|Baseline|Total|Total of all reporting groups
11156104|NCT01914393|FG000|Participant Flow|Rollover From D1050301|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
11156105|NCT01914393|FG001|Participant Flow|Rollover From D1050325|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
11156106|NCT01914393|FG002|Participant Flow|Rollover From D1050326|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
11156107|NCT01914393|OG000|Outcome|Rollover From D1050301|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
11156108|NCT01914393|OG001|Outcome|Rollover From D1050325|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
11156109|NCT01914393|OG002|Outcome|Rollover From D1050326|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
11156110|NCT01914393|OG003|Outcome|Lurasidone (All Indications)|L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
11156111|NCT01914393|OG000|Outcome|Rollover From D1050325|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
11156112|NCT01914393|OG000|Outcome|Rollover From D1050326|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
11156113|NCT01914393|EG000|Reported Event|Rollover From D1050301|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
11156114|NCT01914393|EG001|Reported Event|Rollover From D1050325|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
11156115|NCT01914393|EG002|Reported Event|Rollover From D1050326|Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
11156116|NCT01914393|EG003|Reported Event|Total D1050302|total from study
11156117|NCT01914510|BG000|Baseline|ENMD-2076|ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday for 28 day cycles. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday for 28 day cycles. Patients can continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface under 1.65m2) are permitted, with up to two weeks of therapy interruptions permitted for recovery from toxicity or intercurrent illness.
11156118|NCT01914510|FG000|Participant Flow|ENMD-2076|ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday, for the 28-day cycles. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients continue treatment until disease progression or unacceptable toxicity. Two dose reductions, 225mg and 150mg, are allowed (200mg and 150mg for patients with a body surface area under 1.65m2) and interruptions of therapy up to two weeks are permitted for recovery from toxicity or intercurrent illness.
11156119|NCT01914510|OG000|Outcome|ENMD-2076|ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of therapy interruption for recovery from toxicity or intercurrent illness.
11156120|NCT01914510|OG000|Outcome|ENMD-2076|ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of interrupted therapy for recovery from toxicities or intercurrent illness.
11156121|NCT01914510|EG000|Reported Event|ENMD-2076|ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of therapy interruption for recovery from toxicity or intercurrent illness.
11156122|NCT01914666|BG000|Baseline|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156123|NCT01914666|BG001|Baseline|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156124|NCT01914666|BG002|Baseline|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156125|NCT01914666|BG003|Baseline|Total|Total of all reporting groups
11156126|NCT01914666|FG000|Participant Flow|Naïve|New participants (Pts) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156127|NCT01914666|FG001|Participant Flow|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY [NCT#01855919]) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156128|NCT01914666|FG002|Participant Flow|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156129|NCT01914666|OG000|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156130|NCT01914666|OG001|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156131|NCT01914666|OG002|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
11156132|NCT01914666|EG000|Reported Event|Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)|All participants from Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg) groups combined.
11156133|NCT01914679|BG000|Baseline|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
11156134|NCT01914679|FG000|Participant Flow|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments), and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
11156135|NCT01914679|OG000|Outcome|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
11156136|NCT01914679|EG000|Reported Event|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
11156137|NCT01914757|BG000|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11156138|NCT01914757|BG001|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11156139|NCT01914757|BG002|Baseline|Placebo|Placebo administered subcutaneously
11156140|NCT01914757|BG003|Baseline|Total|Total of all reporting groups
11156141|NCT01914757|FG000|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11156142|NCT01914757|FG001|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11156143|NCT01914757|FG002|Participant Flow|Placebo|Placebo administered subcutaneously
11156144|NCT01914757|OG000|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11156145|NCT01914757|OG001|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11156146|NCT01914757|OG002|Outcome|Placebo|Placebo administered subcutaneously
11156147|NCT01914757|EG000|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11156148|NCT01914757|EG001|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11156149|NCT01914757|EG002|Reported Event|Placebo|Placebo administered subcutaneously
11173856|NCT02018562|EG000|Reported Event|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
11173857|NCT02018562|EG001|Reported Event|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
11173858|NCT02018627|BG000|Baseline|Xeris Glucagon First, Then Lilly Glucagon|"Xeris glucagon 50 micrograms, subcutaneous injection, then Lilly glucagon 30 micrograms, subcutaneous injection~Xeris glucagon: The subject is given an injection of xeris glucagon Lilly glucagon: The subject is given an injection of lilly glucagon"
11173859|NCT02018627|BG001|Baseline|Lilly Glucagon First, Then Xeris Glucagon|"Lilly glucagon 30 micrograms, subcutaneous injection, then Xeris glucagon 50 micrograms, subcutaneous injection~Lilly glucagon: The subject is given an injection of lilly glucagon Xeris glucagon: The subject is given an injection of xeris glucagon"
11173860|NCT02018627|BG002|Baseline|Total|Total of all reporting groups
11173861|NCT02018627|FG000|Participant Flow|Xeris Glucagon First, Then Lilly Glucagon|"Xeris glucagon 50 micrograms, subcutaneous injection then Lilly glucagon 30 micrograms, subcutaneous injection~Lilly glucagon: The subject is given an injection of lilly glucagon Xeris glucagon: The subject is given an injection of xeris glucagon"
11173862|NCT02018627|FG001|Participant Flow|Lilly Glucagon First, Then Xeris Glucagon|"Lilly glucagon 30 micrograms, subcutaneous injection then Xeris glucagon 50 micrograms, subcutaneous injection~Lilly glucagon: The subject is given an injection of lilly glucagon Xeris glucagon: The subject is given an injection of xeris glucagon"
11173863|NCT02018627|OG000|Outcome|Xeris Glucagon|"Xeris glucagon 50 micrograms, subcutaneous injection~Xeris glucagon: The subject is given an injection of xeris glucagon"
11173864|NCT02018627|OG001|Outcome|Lilly Glucagon|"Lilly glucagon 30 micrograms, subcutaneous injection~Lilly glucagon: The subject is given an injection of lilly glucagon"
11173865|NCT02018627|EG000|Reported Event|Xeris Glucagon|"Xeris glucagon 50 micrograms, subcutaneous injection~Xeris glucagon: The subject is given an injection of xeris glucagon"
10887737|NCT00502593|OG011|Outcome|Fluarix-C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11173866|NCT02018627|EG001|Reported Event|Lilly Glucagon|"Lilly glucagon 30 micrograms, subcutaneous injection~Lilly glucagon: The subject is given an injection of lilly glucagon"
11173867|NCT02018653|BG000|Baseline|Calcium Alumina-Silicate (CASAD)|CASAD 1 gram orally every 6 hours for up to 6 days.
11173868|NCT02018653|BG001|Baseline|Placebo|Placebo orally every 6 hours for up to 6 days.
11173869|NCT02018653|BG002|Baseline|Total|Total of all reporting groups
11173870|NCT02018653|FG000|Participant Flow|Calcium Alumina-Silicate (CASAD)|CASAD 1 gram orally every 6 hours for up to 6 days.
11173871|NCT02018653|FG001|Participant Flow|Placebo|Placebo orally every 6 hours for up to 6 days.
11173872|NCT02018653|OG000|Outcome|Calcium Alumina-Silicate (CASAD)|CASAD 1 gram orally every 6 hours for up to 6 days.
11173873|NCT02018653|OG001|Outcome|Placebo|Placebo orally every 6 hours for up to 6 days.
11173874|NCT02018653|EG000|Reported Event|Calcium Alumina-Silicate (CASAD)|CASAD 1 gram orally every 6 hours for up to 6 days.
11173875|NCT02018653|EG001|Reported Event|Placebo|Placebo orally every 6 hours for up to 6 days.
11173876|NCT02018809|BG000|Baseline|MAP Daily Notification|"The subject's MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11173877|NCT02018809|BG001|Baseline|MAP Weekly Notification|"The subject's MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11173878|NCT02018809|BG002|Baseline|MAP Missed Doses|"The subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11173879|NCT02018809|BG003|Baseline|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11173880|NCT02018809|BG004|Baseline|Total|Total of all reporting groups
11156150|NCT01914926|BG000|Baseline|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
11156151|NCT01914926|BG001|Baseline|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
11156152|NCT01914926|BG002|Baseline|Total|Total of all reporting groups
11156153|NCT01914926|FG000|Participant Flow|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
11156154|NCT01914926|FG001|Participant Flow|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
11156155|NCT01914926|OG000|Outcome|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
11156156|NCT01914926|OG001|Outcome|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
11156157|NCT01914926|EG000|Reported Event|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
11156158|NCT01914926|EG001|Reported Event|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
11156159|NCT01915095|BG000|Baseline|Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI)|"This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist flexion and precision grip + rTMS; 2. Wrist flexion and precision grip + Sham rTMS.~Participants will complete two study visits each lasting ~2 hours separated by at least two days.~In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~Wrist flexion and precision grip + Sham rTMS:~The same procedures listed above will be completed before and after Sham rTMS."
11156160|NCT01915095|BG001|Baseline|Wrist Flexion and Precision Grip + rTMS and Sham rTMS (Controls)|"This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist flexion and precision grip + rTMS; 2. Wrist flexion and precision grip + Sham rTMS.~Participants will complete two study visits each lasting ~2 hours separated by at least two days.~In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~Wrist flexion and precision grip + Sham rTMS:~The same procedures listed above will be completed before and after Sham rTMS."
11156161|NCT01915095|BG002|Baseline|Wrist Extension and Precision Grip + rTMS and Sham rTMS (SCI)|"This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist extension and precision grip + rTMS; 2. Wrist extension and precision grip + Sham rTMS.~Participants will complete two study visits each lasting ~2 hours separated by at least two days.~In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~Wrist extension and precision grip + Sham rTMS:~The same procedures listed above will be completed before and after Sham rTMS."
11156162|NCT01915095|BG003|Baseline|Wrist Extension and Precision Grip + rTMS and Sham rTMS (Controls)|"This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist extension and precision grip + rTMS; 2. Wrist extension and precision grip + Sham rTMS.~Participants will complete two study visits each lasting ~2 hours separated by at least two days.~In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~Wrist extension and precision grip + Sham rTMS:~The same procedures listed above will be completed before and after Sham rTMS."
11156163|NCT01915095|BG004|Baseline|rTMS/Sham rTMS/Sham rTMS Over Control Brain Area|"This study arm is a 3 way crossover design. Participants are randomized to one of the 3 study groups: rTMS, Sham rTMS, and Sham rTMS over control brain area. Participants will complete all study groups. Each study group consists of one study visit lasting ~2 hours and there is a 1 week washout period between each study visit.~rTMS stimulation: In this group, rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. The maximum voluntary contraction (MVC) will be measured using surface EMG before rTMS and again after.~Sham or fake rTMS stimulation: In this group, Sham rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Sham rTMS over control brain area: In this group, Sham rTMS will be applies over the dorsolateral prefrontal cortex (DLPFC) or at the leg presentation of the primary motor cortex, or at other related control area. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Participants are asked to wait a 1 week washout period between sessions."
11156164|NCT01915095|BG005|Baseline|Training + rTMS|"Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement . Magnetic stimulation will be given during rest and movement.~rTMS: small magnetic pulses will be given to the brain in a non invasive manner.~Training: at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training"
11156165|NCT01915095|BG006|Baseline|Training + Sham rTMS|"Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement . Magnetic stimulation will be given during rest and movement.~Sham rTMS: sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner~Training: at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training"
11156166|NCT01915095|BG007|Baseline|Total|Total of all reporting groups
11156167|NCT01915095|FG000|Participant Flow|Wrist Flexion and Precision Grip + rTMS and Sham rTMS|"This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist flexion and precision grip + rTMS; 2. Wrist flexion and precision grip + Sham rTMS.~Participants will complete two study visits each lasting ~2 hours separated by at least two days.~In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~Wrist flexion and precision grip + Sham rTMS:~The same procedures listed above will be completed before and after Sham rTMS."
11156168|NCT01915095|FG001|Participant Flow|Wrist Extension and Precision Grip + rTMS and Sham rTMS|"This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist extension and precision grip + rTMS; 2. Wrist extension and precision grip + Sham rTMS.~Participants will complete two study visits each lasting ~2 hours separated by at least two days.~In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~Wrist extension and precision grip + Sham rTMS:~The same procedures listed above will be completed before and after Sham rTMS."
11156169|NCT01915095|FG002|Participant Flow|rTMS/Sham rTMS/Sham rTMS Over Control Brain Area|"This study arm is a 3 way crossover design. Participants are randomized to one of the 3 study groups: rTMS, Sham rTMS, and Sham rTMS over control brain area. Participants will complete all study groups. Each study group consists of one study visit lasting ~2 hours and there is a 1 week washout period between each study visit.~rTMS stimulation: In this group, rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. The maximum voluntary contraction (MVC) will be measured using surface EMG before rTMS and again after.~Sham or fake rTMS stimulation: In this group, Sham rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Sham rTMS over control brain area: In this group, Sham rTMS will be applies over the dorsolateral prefrontal cortex (DLPFC) or at the leg presentation of the primary motor cortex, or at other related control area. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Participants are asked to wait a 1 week washout period between sessions."
11156170|NCT01915095|FG003|Participant Flow|Training + rTMS|Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
11156171|NCT01915095|FG004|Participant Flow|Training + Sham rTMS|Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Sham or fake Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
11156172|NCT01915095|OG000|Outcome|Wrist Flexion and Precision Grip + rTMS (SCI)|"This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting ~2 hours separated by at least two days.~In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli(TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials(MEPs) will be taken at minute 0, 10, 30, and 60.~This information is from 5 SCI participants. The same 5 participants also participated in the Wrist flexion and precision grip + Sham rTMS."
11156173|NCT01915095|OG001|Outcome|Wrist Flexion and Precision Grip + Sham rTMS (SCI)|"This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting ~2 hours separated by at least two days.~Wrist flexion and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~This information is from 5 SCI participants. The same 5 participants also participated in the Wrist flexion and precision grip + rTMS."
11156174|NCT01915095|OG002|Outcome|Wrist Flexion and Precision Grip + rTMS (Control)|"This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting ~2 hours separated by at least two days.~In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli(TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials(MEPs) will be taken at minute 0, 10, 30, and 60.~This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist flexion and precision grip + Sham rTMS."
11173881|NCT02018809|FG000|Participant Flow|MAP Daily Notification|"The subject's MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11156175|NCT01915095|OG003|Outcome|Wrist Flexion and Precision Grip + Sham rTMS (Control)|"This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting ~2 hours separated by at least two days.~Wrist flexion and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist flexion and precision grip + rTMS."
11156176|NCT01915095|OG004|Outcome|Wrist Extension and Precision Grip + rTMS (SCI)|"This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting ~2 hours separated by at least two days.~In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli(TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials(MEPs) will be taken at minute 0, 10, 30, and 60.~This information is from 5 SCI participants. The same 5 SCI participants also participated in the Wrist extension and precision grip + Sham rTMS."
11156177|NCT01915095|OG005|Outcome|Wrist Extension and Precision Grip + Sham rTMS (SCI)|"This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting ~2 hours separated by at least two days.~Wrist extension and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~This information is from 5 SCI participants. The same 5 SCI participants also participated in the Wrist extension and precision grip + rTMS."
11156178|NCT01915095|OG006|Outcome|Wrist Extension and Precision Grip + rTMS (Control)|"This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting ~2 hours separated by at least two days.~In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli(TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials(MEPs) will be taken at minute 0, 10, 30, and 60.~This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist extension and precision grip + Sham rTMS."
11156179|NCT01915095|OG007|Outcome|Wrist Extension and Precision Grip + Sham rTMS (Control)|"This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting ~2 hours separated by at least two days.~Wrist extension and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist extension and precision grip + rTMS."
11156180|NCT01915095|OG008|Outcome|rTMS/Sham rTMS/Sham rTMS Over Control Brain Area|"This study arm is a 3 way crossover design. Participants are randomized to one of the 3 study groups: rTMS, Sham rTMS, and Sham rTMS over control brain area. Participants will complete all study groups. Each study group consists of one study visit lasting ~2 hours and there is a 1 week washout period between each study visit.~rTMS stimulation: In this group, rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. The maximum voluntary contraction (MVC) will be measured using surface EMG before rTMS and again after.~Sham or fake rTMS stimulation: In this group, Sham rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Sham rTMS over control brain area: In this group, Sham rTMS will be applies over the dorsolateral prefrontal cortex (DLPFC) or at the leg presentation of the primary motor cortex, or at other related control area. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Participants are asked to wait a 1 week washout period between sessions.~This information is from 5 SCI participants."
11156181|NCT01915095|OG009|Outcome|Training + rTMS|Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
11156182|NCT01915095|OG010|Outcome|Training + Sham rTMS|Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Sham or fake Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
11173882|NCT02018809|FG001|Participant Flow|MAP Weekly Notification|"The subject's MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11173883|NCT02018809|FG002|Participant Flow|MAP Missed Doses|"The subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11156183|NCT01915095|OG000|Outcome|rTMS, Sham rTMS, Sham rTMS Over Control Brain Area|"This study arm is a 3 way crossover design. Participants are randomized to one of the 3 study groups: rTMS, Sham rTMS, and Sham rTMS over control brain area. Participants will complete all study groups. Each study group consists of one study visit lasting ~2 hours and there is a 1 week washout period between each study visit.~rTMS stimulation: In this group, rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. The maximum voluntary contraction (MVC) will be measured using surface EMG before rTMS and again after.~Sham or fake rTMS stimulation: In this group, Sham rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Sham rTMS over control brain area: In this group, Sham rTMS will be applies over the dorsolateral prefrontal cortex (DLPFC) or at the leg presentation of the primary motor cortex, or at other related control area. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Participants are asked to wait a 1 week washout period between sessions.~This information is from 5 SCI participants."
11156184|NCT01915095|OG000|Outcome|Training + rTMS|Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 training sessions, and Post all training sessions.
11156185|NCT01915095|OG001|Outcome|Training + Sham rTMS|Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Sham or fake Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 training sessions, and Post all training sessions.
11156186|NCT01915095|EG000|Reported Event|Wrist Flexion and Precision Grip + rTMS and Sham rTMS|"This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist flexion and precision grip + rTMS; 2. Wrist flexion and precision grip + Sham rTMS.~Participants will complete two study visits each lasting ~2 hours separated by at least two days.~In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~Wrist flexion and precision grip + Sham rTMS:~The same procedures listed above will be completed before and after Sham rTMS."
11156187|NCT01915095|EG001|Reported Event|Wrist Extension and Precision Grip + rTMS and Sham rTMS|"This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist extension and precision grip + rTMS; 2. Wrist extension and precision grip + Sham rTMS.~Participants will complete two study visits each lasting ~2 hours separated by at least two days.~In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.~Wrist extension and precision grip + Sham rTMS:~The same procedures listed above will be completed before and after Sham rTMS."
11156188|NCT01915095|EG002|Reported Event|rTMS/Sham rTMS/Sham rTMS Over Control Brain Area|"This study arm is a 3 way crossover design. Participants are randomized to one of the 3 study groups: rTMS, Sham rTMS, and Sham rTMS over control brain area. Participants will complete all study groups. Each study group consists of one study visit lasting ~2 hours and there is a 1 week washout period between each study visit.~rTMS stimulation: In this group, rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. The maximum voluntary contraction (MVC) will be measured using surface EMG before rTMS and again after.~Sham or fake rTMS stimulation: In this group, Sham rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Sham rTMS over control brain area: In this group, Sham rTMS will be applies over the dorsolateral prefrontal cortex (DLPFC) or at the leg presentation of the primary motor cortex, or at other related control area. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.~Participants are asked to wait a 1 week washout period between sessions."
11156189|NCT01915095|EG003|Reported Event|Training + rTMS|"Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement. Magnetic stimulation will be given during rest and movement.~rTMS: small magnetic pulses will be given to the brain in a non invasive manner.~Training: at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. This is called training"
10887738|NCT00502593|OG000|Outcome|GSK1562902A -A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11156190|NCT01915095|EG004|Reported Event|Training + Sham rTMS|"Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement. Magnetic stimulation will be given during rest and movement.~Sham rTMS: sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner~Training: at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. This is called training"
11156191|NCT01915108|BG000|Baseline|Group R0|remifentanil Ce of 0 ng/ml
11156192|NCT01915108|BG001|Baseline|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156193|NCT01915108|BG002|Baseline|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156194|NCT01915108|BG003|Baseline|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156195|NCT01915108|BG004|Baseline|Total|Total of all reporting groups
11156196|NCT01915108|FG000|Participant Flow|Group R0|remifentanil Ce of 0 ng/ml
11156197|NCT01915108|FG001|Participant Flow|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156198|NCT01915108|FG002|Participant Flow|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156199|NCT01915108|FG003|Participant Flow|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156200|NCT01915108|OG000|Outcome|Group R0|remifentanil Ce of 0 ng/ml
11156201|NCT01915108|OG001|Outcome|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156202|NCT01915108|OG002|Outcome|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156203|NCT01915108|OG003|Outcome|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156204|NCT01915108|EG000|Reported Event|Group R0|"remifentanil Ce of 0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156205|NCT01915108|EG001|Reported Event|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156206|NCT01915108|EG002|Reported Event|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156207|NCT01915108|EG003|Reported Event|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
11156208|NCT01915173|BG000|Baseline|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
11156209|NCT01915173|BG001|Baseline|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
11156210|NCT01915173|BG002|Baseline|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
11156211|NCT01915173|BG003|Baseline|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
11156212|NCT01915173|BG004|Baseline|Total|Total of all reporting groups
11156213|NCT01915173|FG000|Participant Flow|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
11156214|NCT01915173|FG001|Participant Flow|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
11156215|NCT01915173|FG002|Participant Flow|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
11156216|NCT01915173|FG003|Participant Flow|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
11156217|NCT01915173|OG000|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
11156218|NCT01915173|OG001|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
11156219|NCT01915173|OG002|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
11156220|NCT01915173|OG003|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
11156221|NCT01915173|EG000|Reported Event|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
11156222|NCT01915173|EG001|Reported Event|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
11156223|NCT01915173|EG002|Reported Event|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
11156224|NCT01915173|EG003|Reported Event|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
11156225|NCT01915303|BG000|Baseline|All Patients|Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
11156226|NCT01915303|FG000|Participant Flow|All Patients|Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
11156227|NCT01915303|OG000|Outcome|All Patients|Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
11156228|NCT01915303|EG000|Reported Event|All Patients|Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
11156229|NCT01915563|BG000|Baseline|SBT and Extubation|After a SBT patients will be extubated as usual
11156230|NCT01915563|BG001|Baseline|SBT and Rest 60 Min Before Extubation|"After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation~REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation."
11156231|NCT01915563|BG002|Baseline|Total|Total of all reporting groups
11156232|NCT01915563|FG000|Participant Flow|SBT and Extubation|After a SBT patients will be extubated as usual
11156233|NCT01915563|FG001|Participant Flow|SBT and Rest 60 Min Before Extubation|"After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation~REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation."
11156234|NCT01915563|OG000|Outcome|SBT and Extubation|After a SBT patients will be extubated as usual
11156235|NCT01915563|OG001|Outcome|SBT and Rest 60 Min Before Extubation|"After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation~REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation."
11156236|NCT01915563|EG000|Reported Event|SBT and Extubation|After a SBT patients will be extubated as usual
11156237|NCT01915563|EG001|Reported Event|SBT and Rest 60 Min Before Extubation|"After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation~REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation."
11156238|NCT01915732|BG000|Baseline|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
11156239|NCT01915732|BG001|Baseline|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
11156240|NCT01915732|BG002|Baseline|Total|Total of all reporting groups
11156241|NCT01915732|FG000|Participant Flow|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
11156242|NCT01915732|FG001|Participant Flow|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
11156243|NCT01915732|OG000|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
11156244|NCT01915732|OG001|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
11156245|NCT01915732|EG000|Reported Event|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
11156246|NCT01915732|EG001|Reported Event|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
11156247|NCT01915771|BG000|Baseline|Lomitapide|"It will comprise of 2 single oral doses with at least a 14-day washout between doses.~lomitapide: 20 mg dose"
11156248|NCT01915771|FG000|Participant Flow|Lomitapide|"It will comprise of 2 single oral doses with at least a 14-day washout between doses.~lomitapide: 20 mg dose"
11156249|NCT01915771|OG000|Outcome|PK of Lomitapide|PK of Lomitapide Following a Single Oral Capsule Dose of 20 mg Lomitapide During Periods 1 and 2 (PK Set)
11156250|NCT01915771|OG001|Outcome|PK of M1|PK of M1 Following a Single Oral Capsule Dose of 20 mg Lomitapide During Periods 1 and 2 (PK Set)
11156251|NCT01915771|OG002|Outcome|PK of M3|PK of M3 Following a Single Oral Capsule Dose of 20 mg Lomitapide During Periods 1 and 2 (PK Set)
11156252|NCT01915771|OG000|Outcome|PK of Lomitapide|PK of lomitapide Following a Single Oral Capsule Dose of 20 mg Lomitapide During Periods 1 and 2 (PK Set)
11156253|NCT01915771|EG000|Reported Event|Period 1|All 15 subjects who were enrolled in the study received at least one 20 mg dose of lomitapide and had assessments for the analysis of safety during Period 1.
11156254|NCT01915771|EG001|Reported Event|Period 2|Only 13 subjects who were enrolled in the study received 2 single daily doses of 20 mg lomitapide as planned (one dose in each of the two study periods). 2 subjects who only received one dose in Period 1 due to early withdrawal were not included in analysis of safety during Period 2.
11156255|NCT01915823|BG000|Baseline|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
11156256|NCT01915823|BG001|Baseline|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
11156257|NCT01915823|BG002|Baseline|Total|Total of all reporting groups
11156258|NCT01915823|FG000|Participant Flow|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
11156259|NCT01915823|FG001|Participant Flow|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
11156260|NCT01915823|OG000|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
11156261|NCT01915823|OG001|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
11156262|NCT01915823|EG000|Reported Event|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
11156263|NCT01915823|EG001|Reported Event|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
11156264|NCT01915849|BG000|Baseline|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
11156265|NCT01915849|BG001|Baseline|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
11156266|NCT01915849|BG002|Baseline|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
11156267|NCT01915849|BG003|Baseline|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
11156268|NCT01915849|BG004|Baseline|Total|Total of all reporting groups
11156269|NCT01915849|FG000|Participant Flow|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
11156270|NCT01915849|FG001|Participant Flow|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
11156271|NCT01915849|FG002|Participant Flow|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
11156272|NCT01915849|FG003|Participant Flow|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
11156273|NCT01915849|OG000|Outcome|LIK066 15 mg|All patients who have received LIK066 15 mg once daily for 4 days.
11156274|NCT01915849|OG001|Outcome|LIK066 50 mg|All patients who have received LIK066 50 mg once daily for 4 days.
11156275|NCT01915849|OG002|Outcome|LIK066 150 mg|All patients who have received LIK066 150 mg once daily for 4 days.
11156276|NCT01915849|OG003|Outcome|Placebo|All patients who have received placebo once daily for 4 days.
11156277|NCT01915849|EG000|Reported Event|Placebo|Placebo
11156278|NCT01915849|EG001|Reported Event|LIK066 15 mg|LIK066 15 mg
11156279|NCT01915849|EG002|Reported Event|LIK066 50 mg|LIK066 50 mg
11156280|NCT01915849|EG003|Reported Event|LIK066 150 mg|LIK066 150 mg
11156281|NCT01915914|BG000|Baseline|Overall|Participants who entered the Acute Phase received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to the affected sites and any newly occurring atopic dermatitis (AD) sites. The efficacy and safety in the Acute Phase assessed every 2 weeks up to 4 weeks or until treatment success. Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with physician static global assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, participants received emollient BID plus FP 0.05% cream OD twice a week, or emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156282|NCT01915914|FG000|Participant Flow|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
11156283|NCT01915914|FG001|Participant Flow|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
11156284|NCT01915914|FG002|Participant Flow|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
11156285|NCT01915914|FG003|Participant Flow|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156286|NCT01915914|OG000|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
11156287|NCT01915914|OG001|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
11156288|NCT01915914|OG000|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156289|NCT01915914|OG001|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156290|NCT01915914|OG000|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
11156291|NCT01915914|OG001|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
11156292|NCT01915914|OG000|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156293|NCT01915914|OG000|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
11156294|NCT01915914|OG000|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week, up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156295|NCT01915914|OG001|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe).During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156296|NCT01915914|OG000|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156297|NCT01915914|OG001|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
11156298|NCT01915914|EG000|Reported Event|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety of FP 0.05% cream was assessed every 2 weeks up to 4 weeks or until treatment success.
11156299|NCT01915914|EG001|Reported Event|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
11156300|NCT01915914|EG002|Reported Event|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
11156301|NCT01915914|EG003|Reported Event|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
11156302|NCT01915940|BG000|Baseline|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
11156303|NCT01915940|BG001|Baseline|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
11156304|NCT01915940|BG002|Baseline|Total|Total of all reporting groups
11156305|NCT01915940|FG000|Participant Flow|Washout + Placebo Ocular Insert|Glaucoma medication washout and placebo ocular insert in each eye for at least 4 weeks.
11156306|NCT01915940|FG001|Participant Flow|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
11156307|NCT01915940|FG002|Participant Flow|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
11156308|NCT01915940|OG000|Outcome|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
11156309|NCT01915940|OG001|Outcome|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
11156310|NCT01915940|EG000|Reported Event|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
11156311|NCT01915940|EG001|Reported Event|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
11156312|NCT01916109|BG000|Baseline|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
11156313|NCT01916109|FG000|Participant Flow|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
11156314|NCT01916109|OG000|Outcome|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
11156315|NCT01916109|EG000|Reported Event|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
11156316|NCT01916226|BG000|Baseline|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
11156317|NCT01916226|BG001|Baseline|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
11156318|NCT01916226|BG002|Baseline|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
11156319|NCT01916226|BG003|Baseline|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
11156320|NCT01916226|BG004|Baseline|Total|Total of all reporting groups
11156321|NCT01916226|FG000|Participant Flow|FPNS 200 μg|Participants self-administered fluticasone propionate nasal spray (FPNS) 200 micrograms (µg) per day as two sprays in each nostril (50 μg per spray) once daily in the morning (AM) for 2 weeks.
11156322|NCT01916226|FG001|Participant Flow|Cetirizine 10 mg|Participants self-administered a 10 milligram (mg) cetrizine capsule once daily in the AM for 2 weeks.
11156323|NCT01916226|FG002|Participant Flow|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
11156324|NCT01916226|FG003|Participant Flow|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
11156325|NCT01916226|OG000|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks
11156326|NCT01916226|OG001|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
11156327|NCT01916226|OG002|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
11156328|NCT01916226|OG003|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
11156329|NCT01916226|OG000|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
11156330|NCT01916226|EG000|Reported Event|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
11156331|NCT01916226|EG001|Reported Event|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
11156332|NCT01916226|EG002|Reported Event|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
11156333|NCT01916226|EG003|Reported Event|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
11156334|NCT01916304|BG000|Baseline|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
11156335|NCT01916304|FG000|Participant Flow|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
11156336|NCT01916304|OG000|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
11156337|NCT01916304|EG000|Reported Event|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
11156338|NCT01916629|BG000|Baseline|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
11156339|NCT01916629|BG001|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11156340|NCT01916629|BG002|Baseline|Total|Total of all reporting groups
11156341|NCT01916629|FG000|Participant Flow|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
11156342|NCT01916629|FG001|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11156343|NCT01916629|OG000|Outcome|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
11156344|NCT01916629|OG001|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11156345|NCT01916629|EG000|Reported Event|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
11156346|NCT01916629|EG001|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11156347|NCT01916655|BG000|Baseline|Usual Care|"standard and typical PAP educational and support protocol~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156348|NCT01916655|BG001|Baseline|Self-Management Care|"Individualized self-management educational and support protocol~Self-Management Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156349|NCT01916655|BG002|Baseline|Self-Management Mobile Care|"Individualized self-management educational and support protocol delivered in part by mobile health tool~Self-Management Mobile Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156350|NCT01916655|BG003|Baseline|Total|Total of all reporting groups
11156351|NCT01916655|FG000|Participant Flow|Usual Care|"standard and typical PAP educational and support protocol~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156352|NCT01916655|FG001|Participant Flow|Self-Management Care|"Individualized self-management educational and support protocol~Self-Management Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156353|NCT01916655|FG002|Participant Flow|Self-Management Mobile Care|"Individualized self-management educational and support protocol delivered in part by mobile health tool~Self-Management Mobile Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156354|NCT01916655|OG000|Outcome|Usual Care|"standard and typical PAP educational and support protocol~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156355|NCT01916655|OG001|Outcome|Self-Management Care|"Individualized self-management educational and support protocol~Self-Management Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156356|NCT01916655|OG002|Outcome|Self-Management Mobile Care|"Individualized self-management educational and support protocol delivered in part by mobile health tool~Self-Management Mobile Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156357|NCT01916655|EG000|Reported Event|Usual Care|"standard and typical PAP educational and support protocol~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156358|NCT01916655|EG001|Reported Event|Self-Management Care|"Individualized self-management educational and support protocol~Self-Management Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156359|NCT01916655|EG002|Reported Event|Self-Management Mobile Care|"Individualized self-management educational and support protocol delivered in part by mobile health tool~Self-Management Mobile Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone~Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study."
11156360|NCT01916681|BG000|Baseline|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
11156361|NCT01916681|BG001|Baseline|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
11156362|NCT01916681|BG002|Baseline|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
11156363|NCT01916681|BG003|Baseline|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
11156364|NCT01916681|BG004|Baseline|Total|Total of all reporting groups
11156365|NCT01916681|FG000|Participant Flow|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
11156366|NCT01916681|FG001|Participant Flow|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
11156367|NCT01916681|FG002|Participant Flow|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
11156368|NCT01916681|FG003|Participant Flow|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
11156369|NCT01916681|OG000|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
11156370|NCT01916681|OG001|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
11156371|NCT01916681|OG002|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
11156372|NCT01916681|OG003|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
11156373|NCT01916681|OG003|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
11156374|NCT01916681|EG000|Reported Event|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
11156375|NCT01916681|EG001|Reported Event|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
11156376|NCT01916681|EG002|Reported Event|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
11156377|NCT01916681|EG003|Reported Event|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
11156378|NCT01916824|BG000|Baseline|Participants With Major Depressive Disorder|Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
11156379|NCT01916824|BG001|Baseline|Healthy Controls|Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
11156380|NCT01916824|BG002|Baseline|Total|Total of all reporting groups
11156381|NCT01916824|FG000|Participant Flow|Participants With Major Depressive Disorder|Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
11156382|NCT01916824|FG001|Participant Flow|Healthy Controls|Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
11156383|NCT01916824|OG000|Outcome|Participants With Major Depressive Disorder|Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
11156384|NCT01916824|OG001|Outcome|Healthy Controls|Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
11156385|NCT01916824|EG000|Reported Event|Participants With Major Depressive Disorder|Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
11156386|NCT01916824|EG001|Reported Event|Healthy Controls|Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
11156387|NCT01916928|BG000|Baseline|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
11156388|NCT01916928|FG000|Participant Flow|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
11156389|NCT01916928|OG000|Outcome|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
10887739|NCT00502593|OG000|Outcome|GSK1562902A-C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
11156390|NCT01916928|EG000|Reported Event|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
11156391|NCT01916941|BG000|Baseline|Prazosin|"Prazosin titrated to 16 mg daily x 6 weeks~Prazosin"
11156392|NCT01916941|BG001|Baseline|Placebo|"Placebo X 6 weeks~Placebo"
11156393|NCT01916941|BG002|Baseline|Total|Total of all reporting groups
11156394|NCT01916941|FG000|Participant Flow|Prazosin|"Prazosin titrated to 16 mg daily x 6 weeks~Prazosin"
11156395|NCT01916941|FG001|Participant Flow|Placebo|"Placebo X 6 weeks~Placebo"
11156396|NCT01916941|OG000|Outcome|Prazosin|"Prazosin titrated to 16 mg daily x 6 weeks~Prazosin"
11156397|NCT01916941|OG001|Outcome|Placebo|"Placebo X 6 weeks~Placebo"
11156398|NCT01916941|EG000|Reported Event|Prazosin|"Prazosin titrated to 16 mg daily x 6 weeks~Prazosin"
11156399|NCT01916941|EG001|Reported Event|Placebo|"Placebo X 6 weeks~Placebo"
11156400|NCT01917006|BG000|Baseline|OnabotulinumtoxinA Dose 1|OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
11156401|NCT01917006|BG001|Baseline|OnabotulinumtoxinA Dose 2|OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
11156402|NCT01917006|BG002|Baseline|OnabotulinumtoxinA Dose 3|OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
11156403|NCT01917006|BG003|Baseline|OnabotulinumtoxinA Dose 4|OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
11156404|NCT01917006|BG004|Baseline|OnabotulinumtoxinA Dose 5|OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
11156405|NCT01917006|BG005|Baseline|OnabotulinumtoxinA Dose 6|OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
11156406|NCT01917006|BG006|Baseline|Placebo|Placebo (normal saline) injected into specified muscle per protocol on Day 1.
11156407|NCT01917006|BG007|Baseline|Total|Total of all reporting groups
11156408|NCT01917006|FG000|Participant Flow|OnabotulinumtoxinA Dose 1|OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
11156409|NCT01917006|FG001|Participant Flow|OnabotulinumtoxinA Dose 2|OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
11156410|NCT01917006|FG002|Participant Flow|OnabotulinumtoxinA Dose 3|OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
11156411|NCT01917006|FG003|Participant Flow|OnabotulinumtoxinA Dose 4|OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
11156412|NCT01917006|FG004|Participant Flow|OnabotulinumtoxinA Dose 5|OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
11156413|NCT01917006|FG005|Participant Flow|OnabotulinumtoxinA Dose 6|OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
11156414|NCT01917006|FG006|Participant Flow|Placebo|Placebo (normal saline) injected into specified muscle per protocol on Day 1.
11156415|NCT01917006|FG007|Participant Flow|OnabotulinumtoxinA Dose 2 (Open-label Period)|Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.
11156416|NCT01917006|OG000|Outcome|OnabotulinumtoxinA Dose 1|OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
11156417|NCT01917006|OG001|Outcome|OnabotulinumtoxinA Dose 2|OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
11156418|NCT01917006|OG002|Outcome|OnabotulinumtoxinA Dose 3|OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
11156419|NCT01917006|OG003|Outcome|OnabotulinumtoxinA Dose 4|OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
11156420|NCT01917006|OG004|Outcome|OnabotulinumtoxinA Dose 5|OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
11156421|NCT01917006|OG005|Outcome|OnabotulinumtoxinA Dose 6|OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
11156422|NCT01917006|OG006|Outcome|Placebo|Placebo (normal saline) injected into specified muscle per protocol on Day 1.
11156423|NCT01917006|EG000|Reported Event|OnabotulinumtoxinA Dose 1|OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
11156424|NCT01917006|EG001|Reported Event|OnabotulinumtoxinA Dose 2|OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1.
11156425|NCT01917006|EG002|Reported Event|OnabotulinumtoxinA Dose 3|OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
11156426|NCT01917006|EG003|Reported Event|OnabotulinumtoxinA Dose 4|OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
11156427|NCT01917006|EG004|Reported Event|OnabotulinumtoxinA Dose 5|OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
11156428|NCT01917006|EG005|Reported Event|OnabotulinumtoxinA Dose 6|OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
11156429|NCT01917006|EG006|Reported Event|Placebo|Placebo (normal saline) injected into specified muscle per protocol on Day 1.
11156430|NCT01917006|EG007|Reported Event|OnabotulinumtoxinA Dose 2 (Open-label Period)|Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.
11156431|NCT01917084|BG000|Baseline|Passive Range of Motion (ROM) Exercise|"A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).~Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age"
11156432|NCT01917084|FG000|Participant Flow|Passive Range of Motion (ROM) Exercise|"A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).~Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age"
11156433|NCT01917084|OG000|Outcome|Passive Range of Motion (ROM) Exercise|"A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).~Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age"
11156434|NCT01917084|EG000|Reported Event|Passive Range of Motion (ROM) Exercise|"A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).~Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age"
11156435|NCT01917136|BG000|Baseline|11c-acetate and 18F-FDG, and Cardiac MRI|"For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.~11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate~[18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG~Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups."
11156436|NCT01917136|FG000|Participant Flow|11c-acetate and 18F-FDG, and Cardiac MRI|"For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.~11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate~[18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG~Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups."
11156437|NCT01917136|OG000|Outcome|11c-acetate and 18F-FDG, and Cardiac MRI|"For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.~11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate~[18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG~Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups."
11173884|NCT02018809|FG003|Participant Flow|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11156438|NCT01917136|EG000|Reported Event|11c-acetate and 18F-FDG, and Cardiac MRI|"For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.~11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate~[18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG~Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups."
11156439|NCT01917188|BG000|Baseline|Full Simulation and Education|"Patients who will receive full simulation and education session prior to discharge.~Full simulation and education"
11156440|NCT01917188|BG001|Baseline|See Simulation Room, Usual Education|"Patients will be shown the simulation room prior to discharge but will only receive usual education.~See simulation room, usual education"
11156441|NCT01917188|BG002|Baseline|Usual Care|Patients will receive usual care by bedside nurse.
11156442|NCT01917188|BG003|Baseline|Total|Total of all reporting groups
11156443|NCT01917188|FG000|Participant Flow|Full Simulation and Education|"Patients who will receive full simulation and education session prior to discharge.~Full simulation and education"
11156444|NCT01917188|FG001|Participant Flow|See Simulation Room, Usual Education|"Patients will be shown the simulation room prior to discharge but will only receive usual education.~See simulation room, usual education"
11156445|NCT01917188|FG002|Participant Flow|Usual Care|Patients will receive usual care by bedside nurse.
11156446|NCT01917188|OG000|Outcome|Full Simulation and Education|"Patients who will receive full simulation and education session prior to discharge.~Full simulation and education"
11156447|NCT01917188|OG001|Outcome|See Simulation Room, Usual Education|"Patients will be shown the simulation room prior to discharge but will only receive usual education.~See simulation room, usual education"
10851402|NCT00306202|OG001|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
11156448|NCT01917188|OG002|Outcome|Usual Care|Patients will receive usual care by bedside nurse.
11156449|NCT01917188|EG000|Reported Event|Full Simulation and Education|"Patients who will receive full simulation and education session prior to discharge.~Full simulation and education"
11156450|NCT01917188|EG001|Reported Event|See Simulation Room, Usual Education|"Patients will be shown the simulation room prior to discharge but will only receive usual education.~See simulation room, usual education"
11156451|NCT01917188|EG002|Reported Event|Usual Care|Patients will receive usual care by bedside nurse.
11156452|NCT01917214|BG000|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
11156453|NCT01917214|FG000|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
11156454|NCT01917214|OG000|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
11156455|NCT01917214|OG000|Outcome|mRCC Cohort: Sutent Therapy and BSC|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
11156456|NCT01917214|EG000|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
11156457|NCT01917344|BG000|Baseline|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
11156458|NCT01917344|FG000|Participant Flow|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
11156459|NCT01917344|OG000|Outcome|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
11156460|NCT01917344|EG000|Reported Event|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
11156461|NCT01917513|BG000|Baseline|Standard Colonoscopy|Patients in this group underwent standard high definition colonoscopy
11156462|NCT01917513|BG001|Baseline|G-EYE™ Colonoscopy|Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
11156463|NCT01917513|BG002|Baseline|Total|Total of all reporting groups
11156464|NCT01917513|FG000|Participant Flow|Standard Colonoscopy|Patients in this group underwent standard high definition colonoscopy
11156465|NCT01917513|FG001|Participant Flow|G-EYE™ Colonoscopy|Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
11156466|NCT01917513|OG000|Outcome|Standard Colonoscopy|Patients in this group underwent standard high definition colonoscopy
11156467|NCT01917513|OG001|Outcome|G-EYE™ Colonoscopy|Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
11156468|NCT01917513|EG000|Reported Event|G-EYE™ Colonoscopy|"G-EYE™ colonoscopy~G-EYE™ colonoscopy: G-EYE™ colonoscopy"
11156469|NCT01917513|EG001|Reported Event|Standard Colonoscopy|"Standard Colonoscopy~Standard Colonoscopy: Standard Colonoscopy"
11156470|NCT01917526|BG000|Baseline|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
11156471|NCT01917526|BG001|Baseline|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
11156472|NCT01917526|BG002|Baseline|Total|Total of all reporting groups
11156473|NCT01917526|FG000|Participant Flow|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
11156474|NCT01917526|FG001|Participant Flow|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
11156475|NCT01917526|OG000|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
11156476|NCT01917526|OG001|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
11156477|NCT01917526|EG000|Reported Event|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
11156478|NCT01917526|EG001|Reported Event|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
11156479|NCT01917656|BG000|Baseline|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
11156480|NCT01917656|BG001|Baseline|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
11156481|NCT01917656|BG002|Baseline|Total|Total of all reporting groups
11156482|NCT01917656|FG000|Participant Flow|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
11156483|NCT01917656|FG001|Participant Flow|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
11156484|NCT01917656|OG000|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
11156485|NCT01917656|OG001|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
11156486|NCT01917656|EG000|Reported Event|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
11156487|NCT01917656|EG001|Reported Event|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
11156488|NCT01917682|BG000|Baseline|Study Cohort|"Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)~CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention"
11156489|NCT01917682|FG000|Participant Flow|Study Cohort|"Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)~CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention"
11156490|NCT01917682|OG000|Outcome|Study Cohort|"Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)~CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention"
11156491|NCT01917682|OG000|Outcome|Visual Estimate|Operator visual estimate of lesion length.
11156492|NCT01917682|EG000|Reported Event|Study Cohort|"Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)~CorPath-assisted Percutaneous Coronary Intervention: Robotic-assisted Percutaneous Coronary Intervention"
10851403|NCT00306202|OG000|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 1 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
11156493|NCT01917747|BG000|Baseline|Standard Scheduling and Follow-up|"The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice.~Standard scheduling and follow-up: The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling."
11156494|NCT01917747|BG001|Baseline|Patient Navigator Group|"The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed.~Patient Navigator: The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatrics."
11156495|NCT01917747|BG002|Baseline|Total|Total of all reporting groups
11156496|NCT01917747|FG000|Participant Flow|Standard Scheduling and Follow-up|The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice. The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test.
11349154|NCT04096365|FG000|Participant Flow|Subcostal Temporary Extracardiac Pacing Lead|"All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.~Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance."
11349155|NCT04096365|OG000|Outcome|Subcostal Temporary Extracardiac Pacing Lead|"All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.~Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance."
11349156|NCT04096365|EG000|Reported Event|Subcostal Temporary Extracardiac Pacing Lead|"All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.~Subcostal Temporary Extracardiac Pacing Lead: The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance."
11349157|NCT04080297|BG000|Baseline|100 mg Q-122|Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.
11349158|NCT04080297|BG001|Baseline|200 mg Q-122|Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.
11349159|NCT04080297|BG002|Baseline|Total|Total of all reporting groups
11349160|NCT04080297|FG000|Participant Flow|100 mg Q-122|Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.
11349161|NCT04080297|FG001|Participant Flow|200 mg Q-122|Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.
11349162|NCT04080297|OG000|Outcome|100 mg Q-122|Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.
11349163|NCT04080297|OG001|Outcome|200 mg Q-122|Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.
10887740|NCT00502593|OG001|Outcome|Fluarix-C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
10887741|NCT00502593|OG002|Outcome|GSK1562902A-C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11349164|NCT04080297|EG000|Reported Event|100 mg Q-122|Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.
11349165|NCT04080297|EG001|Reported Event|200 mg Q-122|Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.
11349166|NCT04115358|BG000|Baseline|Hyaluronic Acid|"Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar.~Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material."
11349167|NCT04115358|BG001|Baseline|Formocresol|"0,1 ml to the orifice of the root canals of the primary molar~Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material."
11349168|NCT04115358|BG002|Baseline|Ferric Sulfate|"0,1 ml to the orifice of the root canals of the primary molar~Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material."
11349169|NCT04115358|BG003|Baseline|Total|Total of all reporting groups
11349170|NCT04115358|FG000|Participant Flow|Hyaluronic Acid|"Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar~Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material."
11349171|NCT04115358|FG001|Participant Flow|Formocresol|"0,1 ml to the orifice of the root canals of the primary molar.~Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material."
11349172|NCT04115358|FG002|Participant Flow|Ferric Sulfate|"0,1 ml to the orifice of the root canals of the primary molar.~Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material."
11156497|NCT01917747|FG001|Participant Flow|Patient Navigator Group|The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing loss is imparted.
11156498|NCT01917747|OG000|Outcome|Standard Scheduling and Follow-up|"The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice.~Standard scheduling and follow-up: The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling."
11156499|NCT01917747|OG001|Outcome|Patient Navigator Group|"The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed.~Patient Navigator: The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatrics."
11156500|NCT01917747|OG000|Outcome|Standard Scheduling and Follow-up|Standard scheduling and follow-up: The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test.
11156501|NCT01917747|OG001|Outcome|Patient Navigator Group|Patient Navigator: The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing.
11156502|NCT01917747|OG000|Outcome|Standard Scheduling and Follow-up|The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice. The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test.
11156503|NCT01917747|OG001|Outcome|Patient Navigator Group|The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing loss is imparted.
11349173|NCT04115358|OG000|Outcome|Hyaluronic Acid|"Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar~Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material."
10887742|NCT00502593|OG003|Outcome|Fluarix-C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11156504|NCT01917747|EG000|Reported Event|Standard Scheduling and Follow-up|"The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice.~Standard scheduling and follow-up: The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling."
11156505|NCT01917747|EG001|Reported Event|Patient Navigator Group|"The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed.~Patient Navigator: The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatrics."
11156506|NCT01917773|BG000|Baseline|Octreotide|"Fasting motility was recorded for at least 60 minutes.~Octreotide 1mcg/kg, maximum of 50mcg was administered subcutaneously (one hour after application of EMLA topical cream). Motility was then recorded for 45-60 minutes.~Patients were then offered a high-fat, high-energy meal as described elsewhere, and motility was recorded for 60 minutes.~Patients then received 1 to 2 doses of bisacodyl (0.2 mg/kg, maximum of 10 mg) through the motility catheter, and motility was recorded."
11156507|NCT01917773|FG000|Participant Flow|Octreotide|This was a non-randomized, single center, open label, and prospective study. Thirteen patients were enrolled in the study. All patient received Octreotide as per study protocol.
11156508|NCT01917773|OG000|Outcome|15 Minutes|The MI for the 15 minutes before and after octreotide infusion was measured.
11156509|NCT01917773|OG001|Outcome|30 Minutes|The MI for the 30 minutes before and after octreotide infusion was measured.
11156510|NCT01917773|OG002|Outcome|45 Minutes|The MI for the 45 minutes before and after octreotide infusion was measured.
11156511|NCT01917773|EG000|Reported Event|All Patients|All 13 patient received octreotide injection. Motility Index (MI) (mm Hg) for the 15 minutes before and after octreotide infusion was measured.
11156512|NCT01917812|BG000|Baseline|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
11156513|NCT01917812|BG001|Baseline|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Unblinded Digital Activity Tracker"
11156514|NCT01917812|BG002|Baseline|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
11156515|NCT01917812|BG003|Baseline|Total|Total of all reporting groups
11156516|NCT01917812|FG000|Participant Flow|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
11156517|NCT01917812|FG001|Participant Flow|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~No Smart Text Messaging = Group does not receive personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker"
11156518|NCT01917812|FG002|Participant Flow|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
11156519|NCT01917812|OG000|Outcome|Blinded Digital Activity Tracker|
11156520|NCT01917812|OG001|Outcome|Unblinded Digital Activity Tracker|
11156521|NCT01917812|OG002|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
11156522|NCT01917812|EG000|Reported Event|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
11156523|NCT01917812|EG001|Reported Event|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Unblinded Digital Activity Tracker"
11156524|NCT01917812|EG002|Reported Event|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
11156525|NCT01917968|BG000|Baseline|Uphold Lightweight Vaginal Support System|"Transvaginal repair with mesh (Uphold LITE)~Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)"
11156526|NCT01917968|BG001|Baseline|Traditional Native Tissue Repair|"Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy~Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy"
11156527|NCT01917968|BG002|Baseline|Total|Total of all reporting groups
11156528|NCT01917968|FG000|Participant Flow|Uphold Lightweight Vaginal Support System|"Transvaginal repair with mesh (Uphold LITE)~Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)"
11156529|NCT01917968|FG001|Participant Flow|Traditional Native Tissue Repair|"Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy~Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy"
11156530|NCT01917968|OG000|Outcome|Uphold Lightweight Vaginal Support System|"Transvaginal repair with mesh (Uphold LITE)~Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)"
11156531|NCT01917968|OG001|Outcome|Traditional Native Tissue Repair|"Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy~Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy"
11156532|NCT01917968|OG001|Outcome|Traditional Native Tissue Repair|"Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy~Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy"
11156533|NCT01917968|OG000|Outcome|Total|Inclusive
11156534|NCT01917968|OG001|Outcome|Mild|Measure of Severity
11156535|NCT01917968|OG002|Outcome|Moderate|Measure of Severity
11156536|NCT01917968|OG003|Outcome|Severe|Measure of Severity
11156537|NCT01917968|OG000|Outcome|Uphold LITE|"Transvaginal repair with mesh (Uphold LITE)~Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)"
11156538|NCT01917968|OG001|Outcome|Native Tissue Repair|"Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy~Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy"
11156539|NCT01917968|EG000|Reported Event|Uphold Lightweight Vaginal Support System|"Transvaginal repair with mesh (Uphold LITE)~Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)"
11156540|NCT01917968|EG001|Reported Event|Traditional Native Tissue Repair|"Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy~Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy"
11156541|NCT01918072|BG000|Baseline|VA Primary Care Providers Delivering Women's Health Care|Primary care providers in VA healthcare systems that implemented the DWHP Support women's health clinical innovation (a technology-based program that combines interactive communication with women's health specialist and ongoing education).
11156542|NCT01918072|FG000|Participant Flow|Stepped Wedge Participants|"Designated Women's Health Providers with one or more episodes of care for women patients during each period of the intervention.~Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women."
11156543|NCT01918072|FG001|Participant Flow|Electronic Consultation Survey Participants|"Designated Women's Health Providers who completed surveys about use of electronic consultations.~Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women."
11156544|NCT01918072|FG002|Participant Flow|Quality Assessment Participants|Primary care providers delivering women's health care for one or more of the following conditions: abnormal uterine bleeding; menopausal symptoms; urinary incontinence.
11156545|NCT01918072|OG000|Outcome|Stepped Wedge Participants|"Designated Women's Health Providers with one or more episodes of care for women patients during each period of the intervention.~Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women."
11156546|NCT01918072|OG000|Outcome|Electronic Consultation Survey Participants|"Designated Women's Health Providers who completed surveys about use of electronic consultations.~Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women."
11156547|NCT01918072|OG000|Outcome|Quality Assessment Participants|Primary care providers delivering women's health care for abnormal uterine bleeding.
11156548|NCT01918072|OG000|Outcome|Quality Assessment Participants|Primary care providers delivering women's health care for menopausal symptoms.
11156549|NCT01918072|OG000|Outcome|Quality Assessment Participants|Primary care providers delivering women's health care for urinary incontinence.
11156550|NCT01918072|EG000|Reported Event|Stepped Wedge Participants|"Designated Women's Health Providers with one or more episodes of care for women patients during each period of the intervention.~Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women."
11156551|NCT01918072|EG001|Reported Event|Electronic Consultation Survey Participants|"Designated Women's Health Providers who completed surveys about use of electronic consultations.~Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women."
11156552|NCT01918072|EG002|Reported Event|Quality Assessment Participants|Primary care providers delivering women's health care for one or more of the following conditions: abnormal uterine bleeding; menopausal symptoms; urinary incontinence.
11156553|NCT01918085|BG000|Baseline|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
11156554|NCT01918085|BG001|Baseline|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
11156555|NCT01918085|BG002|Baseline|Total|Total of all reporting groups
11156556|NCT01918085|FG000|Participant Flow|First Pre-stripped Abdominal Skin, Then Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
11156557|NCT01918085|FG001|Participant Flow|First Peristomal Skin, Then Pre-stripped Abdomianl Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
11156558|NCT01918085|OG000|Outcome|Peristomal Skin- Strata Adhesive|"The peel force used to remove a strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive"
11156559|NCT01918085|OG001|Outcome|Pre-stripped Abdominal Skin -Strata Adhesive|"The peel force used to remove a strata strip from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive"
11156560|NCT01918085|OG002|Outcome|Pre-stripped Abdominal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin~hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
11156561|NCT01918085|OG003|Outcome|Peristomal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin~hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
11156562|NCT01918085|EG000|Reported Event|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
11156563|NCT01918085|EG001|Reported Event|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
11156564|NCT01918189|BG000|Baseline|10 Week Pain EASE Access|"behavioral pain self-management intervention (Pain EASE) delivered via the Internet~behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing"
11156565|NCT01918189|FG000|Participant Flow|10 Week Pain EASE Access|"behavioral pain self-management intervention (Pain EASE) delivered via the Internet~behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing"
11156566|NCT01918189|OG000|Outcome|10 Week Pain EASE Access|"behavioral pain self-management intervention (Pain EASE) delivered via the Internet~behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing"
11156567|NCT01918189|OG000|Outcome|Behavioral Pain Self-management Intervention (Pain EASE)|10 weeks access to behavioral pain self-management intervention (Pain EASE) for low back pain delivered via the Internet
11156568|NCT01918189|EG000|Reported Event|10 Week Pain EASE Access|"behavioral pain self-management intervention (Pain EASE) for chronic low back pain delivered via the Internet~behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing~Access to the Pain EASE intervention for 10 weeks: analyses were conducted to determine change from baseline on pain-related functional interference and other outcomes"
11156569|NCT01918306|BG000|Baseline|Cisplatin|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~--------------------------------------------------------------------------------~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156570|NCT01918306|BG001|Baseline|Cisplatin and GDC-0941|"Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~--------------------------------------------------------------------------------~GDC -0941: Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity"
11156571|NCT01918306|BG002|Baseline|Total|Total of all reporting groups
11156572|NCT01918306|FG000|Participant Flow|1PHIbA - Arm A - Cisplatin + GDC -0941 Dose Level 1 Cohort 1&2|"Patients receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11156573|NCT01918306|FG001|Participant Flow|1PHIbB - Arm B - Cisplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
11156574|NCT01918306|FG002|Participant Flow|2PHII1 - Arm 1 - Cisplatin Only|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~--------------------------------------------------------------------------------~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156575|NCT01918306|FG003|Participant Flow|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156576|NCT01918306|OG000|Outcome|1PHIbA -Cisplatin and GDC-0941|"Patients receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11156577|NCT01918306|OG000|Outcome|2PHII1 Arm 1 Cisplatin|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~cisplatin:patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156578|NCT01918306|OG001|Outcome|2PHII2 Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156579|NCT01918306|OG002|Outcome|2PHIICO - Crossover to Arm 2 - Cisplatin and GDC-0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156580|NCT01918306|OG000|Outcome|1PHIbA - Cisplatin and GDC-0941 Cohort 1|"Starting dose of GDC - 0941 260mg. De-escalation of the intensity of the dose (if necessary) will proceed among cohorts of 3 patients according to a standard 3+3 algorithm beginning at the highest dose level. (Highest dose = 260mg)~In cohort 1 patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11156581|NCT01918306|OG001|Outcome|1 PHIbA - Arm 1 - Cisplatin and GDC-0941Cohort 2|"Starting dose of GDC - 0941 260mg, no DLT's experienced in cohort 1. Therefore no de-escalation of the intensity of the dose was necessary. An additional cohort of 3 patients will be treated at the same dose level beginning at the highest dose level. (Highest dose = 260mg)~In cohort 2, patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~≤1 patient has a DLT in 6 treated at this same dose, this will be considered a tolerable dose to move to phase II."
11156582|NCT01918306|OG002|Outcome|1PHIbB - Arm B - Cistplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
11156583|NCT01918306|OG000|Outcome|2 PHII1 - ARM 1 Cisplatin|"Patients receive Cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~Cisplatin: patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156584|NCT01918306|OG001|Outcome|2PHII2 - ARM 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11173885|NCT02018809|OG000|Outcome|MAP Daily Notification|"The subject's MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11173886|NCT02018809|OG001|Outcome|MAP Weekly Notification|"The subject's MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11156585|NCT01918306|OG002|Outcome|2PHIICO - Crossover to 2 - Cisplatin + GDC-0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156586|NCT01918306|OG000|Outcome|2PHII1 - Arm 1 - Cisplatin|"Patients receive Cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~Cisplatin: patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156587|NCT01918306|OG001|Outcome|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156588|NCT01918306|OG002|Outcome|2PHIICO - Crossover to Arm 2 - Cistplatin + GDC - 0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156589|NCT01918306|EG000|Reported Event|1PHIbA - Arm A - Cisplatin + GDC - 0941 Dose Level 1|"Patients cohort 1 receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~If no patients in Cohort 1 experienced DLT's after 4 weeks, all patients in Cohort 2 will receive cisplatin and PI3K inhibitor GDC-0941, GDC-0941dose not to exceed 260mg.~If 1 patient experiences a DLT in the first cohort, an additional cohort of 3 patients will be treated at the same dose level in cohort 2.~If ≤1 patient has a DLT in 6 (cohort 1 and 2) treated at this same dose, this will be considered a tolerable dose to move to phase II."
11156590|NCT01918306|EG001|Reported Event|1PHIbB - Arm B - Cisplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
11156591|NCT01918306|EG002|Reported Event|2PHII 1 - Arm 1 - Cisplatin Only|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~cisplatin:patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~--------------------------------------------------------------------------------~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156592|NCT01918306|EG003|Reported Event|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~--------------------------------------------------------------------------------~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies~GDC -0941: Patients receive cisplatin as in Arm I and PI3K"
11156593|NCT01918306|EG004|Reported Event|2PHIICO - Crossover to Arm 2 - Cistplatin + GDC -0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patient received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
11156594|NCT01918332|BG000|Baseline|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
11156595|NCT01918332|BG001|Baseline|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
11156596|NCT01918332|BG002|Baseline|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
11156597|NCT01918332|BG003|Baseline|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
11156598|NCT01918332|BG004|Baseline|Total|Total of all reporting groups
11156599|NCT01918332|FG000|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
11156600|NCT01918332|FG001|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
11156601|NCT01918332|FG002|Participant Flow|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
11156602|NCT01918332|FG003|Participant Flow|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
11156603|NCT01918332|OG000|Outcome|V160+R20 & V160|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg + Rosuvastatin 20mg placebo
11156604|NCT01918332|OG001|Outcome|R20 & Placebo|Valsartan 160mg placebo + Rosuvastatin 20mg & Placebo
11156605|NCT01918332|OG000|Outcome|V160+R20 & R20|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg placebo + Rosuvastatin 20mg
11156606|NCT01918332|OG001|Outcome|V160 & Placebo|Valsartan 160mg + Rosuvastatin 20mg placebo & Placebo
11156607|NCT01918332|EG000|Reported Event|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
11156608|NCT01918332|EG001|Reported Event|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
11156609|NCT01918332|EG002|Reported Event|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
11156610|NCT01918332|EG003|Reported Event|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
11156611|NCT01918371|BG000|Baseline|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
11156612|NCT01918371|BG001|Baseline|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
11156613|NCT01918371|BG002|Baseline|Total|Total of all reporting groups
11156614|NCT01918371|FG000|Participant Flow|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
11156615|NCT01918371|FG001|Participant Flow|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
11156616|NCT01918371|OG000|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
11156617|NCT01918371|OG001|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
11156618|NCT01918371|EG000|Reported Event|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
11156619|NCT01918371|EG001|Reported Event|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
11156620|NCT01918761|BG000|Baseline|Dacomitinib, Pemetrexed|"Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)~Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)"
11156621|NCT01918761|FG000|Participant Flow|Dacomitinib, Pemetrexed|"Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)~Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)"
11156622|NCT01918761|OG000|Outcome|Dacomitinib, Pemetrexed|"Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)~Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)"
11156623|NCT01918761|EG000|Reported Event|Dacomitinib, Pemetrexed|"Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)~Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)"
11156624|NCT01918774|BG000|Baseline|Cognitive Behavioral Therapy for Work Success|Adults with mental illness who are receiving vocational services and have a competitive work goal will take part in the 12-session Cognitive Behavioral Therapy for Work Success (CBTw) intervention. CBTw is a group-based intervention that occurs weekly (1 hour group sessions) for 12 weeks.
11156625|NCT01918774|FG000|Participant Flow|Cognitive Behavioral Therapy for Work Success|Adults with mental illness who are receiving vocational services and have a competitive work goal will take part in the 12-session Cognitive Behavioral Therapy for Work Success (CBTw) intervention. CBTw is a group-based intervention that occurs weekly (1 hour group sessions) for 12 weeks.
11173887|NCT02018809|OG002|Outcome|MAP Missed Doses|"The subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11156626|NCT01918774|OG000|Outcome|Cognitive Behavioral Therapy for Work Success|Adults with mental illness who are receiving vocational services and have a competitive work goal will take part in the 12-session Cognitive Behavioral Therapy for Work Success (CBTw) intervention. CBTw is a group-based intervention that occurs weekly (1 hour group sessions) for 12 weeks.
11156627|NCT01918774|EG000|Reported Event|Cognitive Behavioral Therapy for Work Success|Adults with mental illness who are receiving vocational services and have a competitive work goal will take part in the 12-session Cognitive Behavioral Therapy for Work Success (CBTw) intervention. CBTw is a group-based intervention that occurs weekly (1 hour group sessions) for 12 weeks.
11156628|NCT01918800|BG000|Baseline|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
11156629|NCT01918800|BG001|Baseline|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
11156630|NCT01918800|BG002|Baseline|Total|Total of all reporting groups
11156631|NCT01918800|FG000|Participant Flow|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
11156632|NCT01918800|FG001|Participant Flow|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
11156633|NCT01918800|OG000|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
11156634|NCT01918800|OG001|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
11156635|NCT01918800|EG000|Reported Event|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
11156636|NCT01918800|EG001|Reported Event|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
11156637|NCT01919112|BG000|Baseline|High Dose Anodal tDCS|"High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156638|NCT01919112|BG001|Baseline|Low Dose Anodal tDCS|"This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156639|NCT01919112|BG002|Baseline|Sham Stimulation|"Twice daily swallowing exercises only~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156640|NCT01919112|BG003|Baseline|Total|Total of all reporting groups
11156641|NCT01919112|FG000|Participant Flow|High Dose Anodal tDCS|"High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156642|NCT01919112|FG001|Participant Flow|Low Dose Anodal tDCS|"This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156643|NCT01919112|FG002|Participant Flow|Sham Stimulation|"Twice daily swallowing exercises only~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156644|NCT01919112|OG000|Outcome|High Dose Anodal tDCS|"High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156645|NCT01919112|OG001|Outcome|Low Dose Anodal tDCS|"This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156646|NCT01919112|OG002|Outcome|Sham Stimulation|"Twice daily swallowing exercises only~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156647|NCT01919112|EG000|Reported Event|High Dose Anodal tDCS|"High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156648|NCT01919112|EG001|Reported Event|Low Dose Anodal tDCS|"This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156649|NCT01919112|EG002|Reported Event|Sham Stimulation|"Twice daily swallowing exercises only~tDCS: Anodal tDCS will be administered with swallowing exercises"
11156650|NCT01919164|BG000|Baseline|Placebo|Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156651|NCT01919164|BG001|Baseline|Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles|Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156652|NCT01919164|BG002|Baseline|Sprifermin (AS902330) 30 mcg- 4 Cycles|Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11173888|NCT02018809|OG003|Outcome|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11156653|NCT01919164|BG003|Baseline|Sprifermin (AS902330) 100 mcg/Placebo- 2 Cycles|Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156654|NCT01919164|BG004|Baseline|Sprifermin (AS902330) 100 mcg- 4 Cycles|Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156655|NCT01919164|BG005|Baseline|Total|Total of all reporting groups
11156656|NCT01919164|FG000|Participant Flow|Placebo|Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156657|NCT01919164|FG001|Participant Flow|Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles|Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156658|NCT01919164|FG002|Participant Flow|Sprifermin (AS902330) 30 mcg- 4 Cycles|Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156659|NCT01919164|FG003|Participant Flow|Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles)|Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156660|NCT01919164|FG004|Participant Flow|Sprifermin (AS902330) 100 mcg- 4 Cycles|Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156661|NCT01919164|OG000|Outcome|Placebo|Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156662|NCT01919164|OG001|Outcome|Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles|Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156663|NCT01919164|OG002|Outcome|Sprifermin (AS902330) 30 mcg- 4 Cycles|Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156664|NCT01919164|OG003|Outcome|Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles)|Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156665|NCT01919164|OG004|Outcome|Sprifermin (AS902330) 100 mcg- 4 Cycles|Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156666|NCT01919164|EG000|Reported Event|Placebo|Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156667|NCT01919164|EG001|Reported Event|Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles|Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156668|NCT01919164|EG002|Reported Event|Sprifermin (AS902330) 30 mcg- 4 Cycles|Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156669|NCT01919164|EG003|Reported Event|Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles)|Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156670|NCT01919164|EG004|Reported Event|Sprifermin (AS902330) 100 mcg- 4 Cycles|Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
11156671|NCT01919190|BG000|Baseline|EXPAREL|"EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP.~EXPAREL"
11156672|NCT01919190|BG001|Baseline|Placebo|"The placebo control was established using a grade-2 sham; no infiltration occurred.~Placebo"
11156673|NCT01919190|BG002|Baseline|Total|Total of all reporting groups
11156674|NCT01919190|FG000|Participant Flow|EXPAREL|"EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP.~EXPAREL"
11156675|NCT01919190|FG001|Participant Flow|Placebo|"The placebo control was established using a grade-2 sham; no infiltration occurred.~Placebo"
11156676|NCT01919190|OG000|Outcome|EXPAREL|"EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP~EXPAREL"
11156677|NCT01919190|OG001|Outcome|Placebo|"The placebo control will be established using a grade-2 sham, no infiltration will occur~Placebo"
11156678|NCT01919190|OG000|Outcome|EXPAREL|"EXPAREL (266mg /20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP~EXPAREL"
11156679|NCT01919190|EG000|Reported Event|EXPAREL|"EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP~EXPAREL"
11156680|NCT01919190|EG001|Reported Event|Placebo|"The placebo control will be established using a grade-2 sham, no infiltration will occur~Placebo"
11156681|NCT01919216|BG000|Baseline|Open Track|"Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.~Citalopram"
11156682|NCT01919216|BG001|Baseline|Placebo Track - Citalopram|"Blinded treatment with citalopram 20mg , increased to citalopram 40mg at week 4 if depression has not remitted.~Citalopram"
11156683|NCT01919216|BG002|Baseline|Placebo Track - Placebo|Blinded treatment with placebo
11156684|NCT01919216|BG003|Baseline|Total|Total of all reporting groups
11156685|NCT01919216|FG000|Participant Flow|Open Track|"Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.~Citalopram"
11156686|NCT01919216|FG001|Participant Flow|Placebo Track - Citalopram|"Blinded treatment with either citalopram 20mg, increased to citalopram 40mg at week 4 if depression has not remitted.~Citalopram"
11156687|NCT01919216|FG002|Participant Flow|Placebo Track - Placebo|Blinded treatment with either placebo
11156688|NCT01919216|OG000|Outcome|Open Track|"Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.~Citalopram"
11156689|NCT01919216|OG001|Outcome|Placebo Track - Citalopram|"Blinded treatment with either citalopram 20mg, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.~Citalopram"
11156690|NCT01919216|OG002|Outcome|Placebo Track - Placebo|Blinded treatment with placebo
11156691|NCT01919216|EG000|Reported Event|Open Track|"Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.~Citalopram"
11156692|NCT01919216|EG001|Reported Event|Placebo Track - Citalopram|"Blinded treatment with citalopram 20mg, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.~Citalopram"
11156693|NCT01919216|EG002|Reported Event|Placebo Track - Placebo|Blinded treatment with placebo
11156694|NCT01919229|BG000|Baseline|Letrozole|Letrozole 2.5 mg alone once daily
11156695|NCT01919229|BG001|Baseline|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
11156696|NCT01919229|BG002|Baseline|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
11156697|NCT01919229|BG003|Baseline|Total|Total of all reporting groups
11156698|NCT01919229|FG000|Participant Flow|Letrozole|Letrozole 2.5 mg alone once daily
11156699|NCT01919229|FG001|Participant Flow|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
11156700|NCT01919229|FG002|Participant Flow|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
11156701|NCT01919229|OG000|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
11156702|NCT01919229|OG001|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
11156703|NCT01919229|OG002|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
11156704|NCT01919229|EG000|Reported Event|Letrozole2.5mgqd|Letrozole 2.5 mg alone once daily
11156705|NCT01919229|EG001|Reported Event|LEE400mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
11156706|NCT01919229|EG002|Reported Event|LEE600mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
11156707|NCT01919307|BG000|Baseline|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
11156708|NCT01919307|FG000|Participant Flow|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
11173889|NCT02018809|EG000|Reported Event|MAP Daily Notification|"The subject's MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11156709|NCT01919307|OG000|Outcome|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
11156710|NCT01919307|EG000|Reported Event|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
11156711|NCT01919398|BG000|Baseline|Cohort 1: 100 mg LY2940680|"Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156712|NCT01919398|BG001|Baseline|Cohort 2: 200 mg LY2940680|"Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156713|NCT01919398|BG002|Baseline|Cohort 3: 400 mg LY2940680|"Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156714|NCT01919398|BG003|Baseline|Total|Total of all reporting groups
11156715|NCT01919398|FG000|Participant Flow|Cohort 1: 100 mg LY2940680|"Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156716|NCT01919398|FG001|Participant Flow|Cohort 2: 200 mg LY2940680|"Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156717|NCT01919398|FG002|Participant Flow|Cohort 3: 400 mg LY2940680|"Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156718|NCT01919398|OG000|Outcome|Cohort 1: 100 mg LY2940680|"Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156719|NCT01919398|OG001|Outcome|Cohort 2: 200 mg LY2940680|"Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156720|NCT01919398|OG002|Outcome|Cohort 3: 400 mg LY2940680|"Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156721|NCT01919398|EG000|Reported Event|Cohort 1: 100 mg LY2940680|"Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
10887743|NCT00502593|OG002|Outcome|GSK1562902A-B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11156722|NCT01919398|EG001|Reported Event|Cohort 2: 200 mg LY2940680|"Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156723|NCT01919398|EG002|Reported Event|Cohort 3: 400 mg LY2940680|"Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.~Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met."
11156724|NCT01919411|BG000|Baseline|Amoxicillin-Potassium Clavulanate|All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.
11156725|NCT01919411|BG001|Baseline|Placebo|All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
11156726|NCT01919411|BG002|Baseline|Total|Total of all reporting groups
11156727|NCT01919411|FG000|Participant Flow|Amoxicillin-Potassium Clavulanate|All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.
11156728|NCT01919411|FG001|Participant Flow|Placebo|All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
11156729|NCT01919411|OG000|Outcome|Amoxicillin-Potassium Clavulanate|All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.
11156730|NCT01919411|OG001|Outcome|Placebo|All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
11156731|NCT01919411|EG000|Reported Event|Amoxicillin-Potassium Clavulanate|All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.
11156732|NCT01919411|EG001|Reported Event|Placebo|All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
11156733|NCT01919450|BG000|Baseline|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156734|NCT01919450|BG001|Baseline|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156735|NCT01919450|BG002|Baseline|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156736|NCT01919450|BG003|Baseline|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156737|NCT01919450|BG004|Baseline|Total|Total of all reporting groups
11156738|NCT01919450|FG000|Participant Flow|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156739|NCT01919450|FG001|Participant Flow|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156740|NCT01919450|FG002|Participant Flow|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156741|NCT01919450|FG003|Participant Flow|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156742|NCT01919450|OG000|Outcome|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156743|NCT01919450|OG000|Outcome|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156744|NCT01919450|OG000|Outcome|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156745|NCT01919450|OG000|Outcome|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156746|NCT01919450|EG000|Reported Event|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156747|NCT01919450|EG001|Reported Event|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156748|NCT01919450|EG002|Reported Event|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156749|NCT01919450|EG003|Reported Event|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
11156750|NCT01919489|BG000|Baseline|Liraglutide + OADs|"Liraglutide once daily in combination to oral anti-diabetic agents (OADs)~Liraglutide + OADs: Liraglutide subcutaneously daily"
11156751|NCT01919489|BG001|Baseline|Glargine + OADs|"Glargine once daily in combination to oral anti-diabetic agents (OADs)~Glargine + OADs: Glargine once daily subcutaneously"
11156752|NCT01919489|BG002|Baseline|Total|Total of all reporting groups
11156753|NCT01919489|FG000|Participant Flow|Liraglutide + OADs|"Liraglutide once daily in combination to oral anti-diabetic agents (OADs)~Liraglutide + OADs: Liraglutide subcutaneously daily"
11156754|NCT01919489|FG001|Participant Flow|Glargine + OADs|"Glargine once daily in combination to oral anti-diabetic agents (OADs)~Glargine + OADs: Glargine once daily subcutaneously"
11156755|NCT01919489|OG000|Outcome|Liraglutide + OADs|"Liraglutide once daily in combination to oral anti-diabetic agents (OADs)~Liraglutide + OADs: Liraglutide subcutaneously daily"
11156756|NCT01919489|OG001|Outcome|Glargine + OADs|"Glargine once daily in combination to oral anti-diabetic agents (OADs)~Glargine + OADs: Glargine once daily subcutaneously"
11156757|NCT01919489|EG000|Reported Event|Liraglutide + OADs|"Liraglutide once daily in combination to oral anti-diabetic agents (OADs)~Liraglutide + OADs: Liraglutide subcutaneously daily"
11156758|NCT01919489|EG001|Reported Event|Glargine + OADs|"Glargine once daily in combination to oral anti-diabetic agents (OADs)~Glargine + OADs: Glargine once daily subcutaneously"
11156759|NCT01919606|BG000|Baseline|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
11156760|NCT01919606|BG001|Baseline|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
11156761|NCT01919606|BG002|Baseline|Total|Total of all reporting groups
11156762|NCT01919606|FG000|Participant Flow|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
11156763|NCT01919606|FG001|Participant Flow|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
11156764|NCT01919606|OG000|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
11156765|NCT01919606|OG001|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
11156766|NCT01919606|EG000|Reported Event|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
11156767|NCT01919606|EG001|Reported Event|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
11156768|NCT01919697|BG000|Baseline|Plecanatide 3 mg|Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
11156769|NCT01919697|BG001|Baseline|Plecanatide 6 mg|Plecanatide 6 mg, one tablet by mouth daily for up to 72 weeks
11156770|NCT01919697|BG002|Baseline|Total|Total of all reporting groups
11156771|NCT01919697|FG000|Participant Flow|Plecanatide 3 mg|Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
11156772|NCT01919697|FG001|Participant Flow|Plecantide 6 mg|Plecanatide 6 mg, one tablet by mouth daily for up to 72 weeks
11156773|NCT01919697|OG000|Outcome|Plecanatide 3 mg|Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
11156774|NCT01919697|OG001|Outcome|Plecantide 6 mg|Plecanatide 6 mg, one tablet by mouth daily for 72 weeks
11156775|NCT01919697|OG000|Outcome|Plecanatide 3 mg|Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
11156776|NCT01919697|EG000|Reported Event|Plecanatide 3 mg|Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
11156777|NCT01919697|EG001|Reported Event|Plecanatide 6 mg|Plecanatide 6 mg, one tablet by mouth daily for 72 weeks
11156778|NCT01919723|BG000|Baseline|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~Ticagrelor: Ticagrelor loading dose~Eptifibatide: i.v. infusion"
11156779|NCT01919723|BG001|Baseline|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~Ticagrelor: Ticagrelor loading dose~Eptifibatide: i.v. infusion"
11156780|NCT01919723|BG002|Baseline|Total|Total of all reporting groups
11156781|NCT01919723|FG000|Participant Flow|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
11156782|NCT01919723|FG001|Participant Flow|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
11156783|NCT01919723|OG000|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
11156784|NCT01919723|OG001|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
11156785|NCT01919723|EG000|Reported Event|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
11156786|NCT01919723|EG001|Reported Event|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
11156787|NCT01919801|BG000|Baseline|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
11156788|NCT01919801|BG001|Baseline|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
11156789|NCT01919801|BG002|Baseline|Total|Total of all reporting groups
11156790|NCT01919801|FG000|Participant Flow|Icatibant 30 mg|Participants received a single dose of icatibant 30 milligram (mg) subcutaneous (SC) injection within 12 hours after the onset of the angiotensin-converting enzyme inhibitor (ACE-I) induced angioedema attack.
11156791|NCT01919801|FG001|Participant Flow|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
11156792|NCT01919801|OG000|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
11156793|NCT01919801|OG001|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
11156794|NCT01919801|EG000|Reported Event|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
11156795|NCT01919801|EG001|Reported Event|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
11228186|NCT02388646|EG002|Reported Event|Bracing + Exercises|"Reaction Web brace and home exercises.~Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group."
11156796|NCT01919814|BG000|Baseline|All Participants|"Appethyl™ liquid or Placebo once four hours after breakfast.~Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™ pr Placebo.~Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza."
11156797|NCT01919814|FG000|Participant Flow|Appethyl™ First, Then Placebo|"Appethyl™ liquid once four hours after breakfast.~Appethyl™: • Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. After one week washout period, participants were given placebo drink.~Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza."
11156798|NCT01919814|FG001|Participant Flow|Placebo First, Then Appethyl™|"Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). After a one week washout period, they were given Appethyl™.~Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza."
11156799|NCT01919814|OG000|Outcome|Appethyl™|"Appethyl™ liquid once four hours after breakfast.~Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza."
11156800|NCT01919814|OG001|Outcome|Placebo|Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
11156801|NCT01919814|EG000|Reported Event|Appethyl™|"Appethyl™ liquid once four hours after breakfast.~Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza."
11156802|NCT01919814|EG001|Reported Event|Placebo|Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
11156803|NCT01919970|BG000|Baseline|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.~Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions."
11156804|NCT01919970|BG001|Baseline|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
11156805|NCT01919970|BG002|Baseline|Total|Total of all reporting groups
11156806|NCT01919970|FG000|Participant Flow|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.~Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions."
11156807|NCT01919970|FG001|Participant Flow|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
11228187|NCT02388724|BG000|Baseline|Vonoprazan 20 mg|Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
10887744|NCT00502593|OG003|Outcome|Fluarix-B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11156808|NCT01919970|OG000|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.~Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions."
11156809|NCT01919970|OG001|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
11156810|NCT01919970|EG000|Reported Event|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.~Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions."
11156811|NCT01919970|EG001|Reported Event|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
11156812|NCT01919996|BG000|Baseline|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
11156813|NCT01919996|FG000|Participant Flow|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
11156814|NCT01919996|OG000|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
11156815|NCT01919996|EG000|Reported Event|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
11156816|NCT01920061|BG000|Baseline|Arm A1: 90 mg PF-05212384 + Docetaxel|Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156817|NCT01920061|BG001|Baseline|Arm A2: 110 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156818|NCT01920061|BG002|Baseline|Arm A3: 130 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156819|NCT01920061|BG003|Baseline|Arm A4: 150 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156820|NCT01920061|BG004|Baseline|Arm A5: 180 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156821|NCT01920061|BG005|Baseline|Arm B1: 90 mg PF-05212384 + Cisplatin|Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156822|NCT01920061|BG006|Baseline|Arm B2: 110 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156823|NCT01920061|BG007|Baseline|Arm B3: 130 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156824|NCT01920061|BG008|Baseline|Arm B4: 150 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156825|NCT01920061|BG009|Baseline|Arm B5: 180 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156826|NCT01920061|BG010|Baseline|Arm B6: 215 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156827|NCT01920061|BG011|Baseline|Arm B7: 260 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156828|NCT01920061|BG012|Baseline|Arm B8: 310 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156829|NCT01920061|BG013|Baseline|Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib|Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156830|NCT01920061|BG014|Baseline|Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11173890|NCT02018809|EG001|Reported Event|MAP Weekly Notification|"The subject's MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11173891|NCT02018809|EG002|Reported Event|MAP Missed Doses|"The subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
10851404|NCT00306202|OG000|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
11156831|NCT01920061|BG015|Baseline|Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156832|NCT01920061|BG016|Baseline|Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156833|NCT01920061|BG017|Baseline|Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156834|NCT01920061|BG018|Baseline|Arm 1: 1L Metastatic|Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156835|NCT01920061|BG019|Baseline|Arm 2: 2L/3L Metastatic|Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156836|NCT01920061|BG020|Baseline|Total|Total of all reporting groups
11156837|NCT01920061|FG000|Participant Flow|Arm A1: 90 mg PF-05212384 + Docetaxel|Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156838|NCT01920061|FG001|Participant Flow|Arm A2: 110 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156839|NCT01920061|FG002|Participant Flow|Arm A3: 130 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156840|NCT01920061|FG003|Participant Flow|Arm A4: 150 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156841|NCT01920061|FG004|Participant Flow|Arm A5: 180 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156842|NCT01920061|FG005|Participant Flow|Arm B1: 90 mg PF-05212384 + Cisplatin|Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156843|NCT01920061|FG006|Participant Flow|Arm B2: 110 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156844|NCT01920061|FG007|Participant Flow|Arm B3: 130 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156845|NCT01920061|FG008|Participant Flow|Arm B4: 150 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156846|NCT01920061|FG009|Participant Flow|Arm B5: 180 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156847|NCT01920061|FG010|Participant Flow|Arm B6: 215 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156848|NCT01920061|FG011|Participant Flow|Arm B7: 260 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156849|NCT01920061|FG012|Participant Flow|Arm B8: 310 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156850|NCT01920061|FG013|Participant Flow|Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib|Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156851|NCT01920061|FG014|Participant Flow|Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156852|NCT01920061|FG015|Participant Flow|Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11173892|NCT02018809|EG003|Reported Event|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11156853|NCT01920061|FG016|Participant Flow|Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156854|NCT01920061|FG017|Participant Flow|Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156855|NCT01920061|FG018|Participant Flow|Arm 1: 1L Metastatic|Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156856|NCT01920061|FG019|Participant Flow|Arm 2: 2L/3L Metastatic|Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156857|NCT01920061|OG000|Outcome|Arm A1: 90 mg PF-05212384 + Docetaxel|Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156858|NCT01920061|OG001|Outcome|Arm A2: 110 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156859|NCT01920061|OG002|Outcome|Arm A3: 130 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156860|NCT01920061|OG003|Outcome|Arm A4: 150 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156861|NCT01920061|OG004|Outcome|Arm A5: 180 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156862|NCT01920061|OG005|Outcome|Arm B1: 90 mg PF-05212384 + Cisplatin|Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156863|NCT01920061|OG006|Outcome|Arm B2: 110 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11173893|NCT02018822|BG000|Baseline|UDMA and TPHs|Participants who needed at least two tooth restorations
11173894|NCT02018822|BG001|Baseline|Esthet-X HD|Participants who needed at least two tooth restorations
11156864|NCT01920061|OG007|Outcome|Arm B3: 130 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156865|NCT01920061|OG008|Outcome|Arm B4: 150 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156866|NCT01920061|OG009|Outcome|Arm B5: 180 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156867|NCT01920061|OG010|Outcome|Arm B6: 215 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156868|NCT01920061|OG011|Outcome|Arm B7: 260 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156869|NCT01920061|OG012|Outcome|Arm B8: 310 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156870|NCT01920061|OG013|Outcome|Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib|Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156871|NCT01920061|OG014|Outcome|Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156872|NCT01920061|OG015|Outcome|Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156873|NCT01920061|OG016|Outcome|Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11173895|NCT02018822|BG002|Baseline|Total|Total of all reporting groups
11156874|NCT01920061|OG017|Outcome|Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156875|NCT01920061|OG000|Outcome|Arm 1: 1L Metastasic|Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156876|NCT01920061|OG001|Outcome|Arm 2: 2L/3L Metastatic|Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156877|NCT01920061|OG018|Outcome|Arm 1: 1L Metastasic|Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156878|NCT01920061|OG019|Outcome|Arm 2: 2L/3L Metastatic|Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156879|NCT01920061|OG000|Outcome|Arm B1: 90 mg PF-05212384 + Cisplatin|Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156880|NCT01920061|OG001|Outcome|Arm B2: 110 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156881|NCT01920061|OG002|Outcome|Arm B3: 130 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156882|NCT01920061|OG003|Outcome|Arm B4: 150 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156883|NCT01920061|OG004|Outcome|Arm B5: 180 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156884|NCT01920061|OG005|Outcome|Arm B6: 215 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156885|NCT01920061|OG006|Outcome|Arm B7: 260 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11173896|NCT02018822|FG000|Participant Flow|UDMA|"Participants who needed at least two tooth restorations~urethane dimethacrylate: Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent~TPH3: light-cured resin composite for teeth~Esthet-X HD: light cured resin composite for teeth made by Dentsply Caulk"
11156886|NCT01920061|OG007|Outcome|Arm B8: 310 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156887|NCT01920061|OG000|Outcome|Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib|Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156888|NCT01920061|OG001|Outcome|Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156889|NCT01920061|OG002|Outcome|Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156890|NCT01920061|OG003|Outcome|Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156891|NCT01920061|OG004|Outcome|Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156892|NCT01920061|OG000|Outcome|Arm A|Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156893|NCT01920061|OG001|Outcome|Arm B|Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156894|NCT01920061|OG002|Outcome|Arm C|Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
10851405|NCT00306202|OG002|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
11156895|NCT01920061|OG001|Outcome|Arm C|Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156896|NCT01920061|OG000|Outcome|Arm B|Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156897|NCT01920061|OG000|Outcome|Arm C|Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156898|NCT01920061|EG000|Reported Event|Arm A1: 90 mg PF-05212384 + Docetaxel|Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156899|NCT01920061|EG001|Reported Event|Arm A2: 110 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156900|NCT01920061|EG002|Reported Event|Arm A3: 130 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156901|NCT01920061|EG003|Reported Event|Arm A4: 150 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156902|NCT01920061|EG004|Reported Event|Arm A5: 180 mg PF-05212384 + Docetaxel|Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
11156903|NCT01920061|EG005|Reported Event|Arm B1: 90 mg PF-05212384 + Cisplatin|Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156904|NCT01920061|EG006|Reported Event|Arm B2: 110 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11173897|NCT02018822|FG001|Participant Flow|TPH3|"Participants who needed at least two tooth restorations~TPH3: light-cured resin composite for teeth"
10851406|NCT00306202|OG003|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
11156905|NCT01920061|EG007|Reported Event|Arm B3: 130 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156906|NCT01920061|EG008|Reported Event|Arm B4: 150 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156907|NCT01920061|EG009|Reported Event|Arm B5: 180 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156908|NCT01920061|EG010|Reported Event|Arm B6: 215 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156909|NCT01920061|EG011|Reported Event|Arm B7: 260 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156910|NCT01920061|EG012|Reported Event|Arm B8: 310 mg PF-05212384 + Cisplatin|Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
11156911|NCT01920061|EG013|Reported Event|Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib|Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156912|NCT01920061|EG014|Reported Event|Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156913|NCT01920061|EG015|Reported Event|Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11173898|NCT02018822|FG002|Participant Flow|Esthet-X|Participants who needed at least two tooth restorations
11173899|NCT02018822|OG000|Outcome|Teeth That Received UDMA|Experimental urethane dimethacylate resin based composite for teeth used with prime and Bond Elect bonding agent
11156914|NCT01920061|EG016|Reported Event|Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156915|NCT01920061|EG017|Reported Event|Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib|Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
11156916|NCT01920061|EG018|Reported Event|Arm 1: 1L Metastatic|Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156917|NCT01920061|EG019|Reported Event|Arm 2: 2L/3L Metastatic|Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
11156918|NCT01920152|BG000|Baseline|Autologous PRP Hip Injection|"Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.~PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique."
11156919|NCT01920152|BG001|Baseline|Hyaluronic Acid Hip Injection|"Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.~Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration."
11156920|NCT01920152|BG002|Baseline|Total|Total of all reporting groups
11156921|NCT01920152|FG000|Participant Flow|Autologous PRP Hip Injection|"Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.~PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique."
11156922|NCT01920152|FG001|Participant Flow|Hyaluronic Acid Hip Injection|"Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.~Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration."
11156923|NCT01920152|OG000|Outcome|Autologous PRP Hip Injection|"Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.~PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique."
11156924|NCT01920152|OG001|Outcome|Hyaluronic Acid Hip Injection|"Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.~Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration."
11173900|NCT02018822|OG001|Outcome|Teeth That Received TPH3|light-cured resin composite for teeth
11156925|NCT01920152|EG000|Reported Event|Autologous PRP Hip Injection|"Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other and completed a minimum 6-week follow-up were included in the study.~PRP: Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique."
11156926|NCT01920152|EG001|Reported Event|Hyaluronic Acid Hip Injection|"Participants were randomized to this group of treatment. Participants who received 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other and completed a minimum 6-week follow-up were included in the study.~Hyaluronic Acid: Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration."
11156927|NCT01920178|BG000|Baseline|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
11156928|NCT01920178|BG001|Baseline|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
11156929|NCT01920178|BG002|Baseline|Total|Total of all reporting groups
11156930|NCT01920178|FG000|Participant Flow|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
11156931|NCT01920178|FG001|Participant Flow|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
11156932|NCT01920178|OG000|Outcome|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
11156933|NCT01920178|OG001|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
11156934|NCT01920178|EG000|Reported Event|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
11156935|NCT01920178|EG001|Reported Event|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
11156936|NCT01920282|BG000|Baseline|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
11156937|NCT01920282|BG001|Baseline|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
11156938|NCT01920282|BG002|Baseline|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
11156939|NCT01920282|BG003|Baseline|Total|Total of all reporting groups
11156940|NCT01920282|FG000|Participant Flow|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
11173901|NCT02018822|OG002|Outcome|Teeth That Received Esthet-X-HD|light cured resin composite for teeth made by Dentsply Caulk
11173902|NCT02018822|OG000|Outcome|UDMA|Experimental urethane dimethacylate resin based composite for teeth used with prime and Bond Elect bonding agent
11173903|NCT02018822|OG001|Outcome|TPH3|light-cured resin composite for teeth
11156941|NCT01920282|FG001|Participant Flow|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
11156942|NCT01920282|FG002|Participant Flow|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
11156943|NCT01920282|OG000|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
11156944|NCT01920282|OG001|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
11156945|NCT01920282|OG002|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
11156946|NCT01920282|EG000|Reported Event|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
10851407|NCT00306202|OG004|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
11156947|NCT01920282|EG001|Reported Event|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
11156948|NCT01920282|EG002|Reported Event|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
11156949|NCT01920477|BG000|Baseline|Ofatumumab|Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
11156950|NCT01920477|BG001|Baseline|Placebo|Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
11156951|NCT01920477|BG002|Baseline|Total|Total of all reporting groups
11156952|NCT01920477|FG000|Participant Flow|Ofatumumab|Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
11156953|NCT01920477|FG001|Participant Flow|Placebo|Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
11156954|NCT01920477|OG000|Outcome|Ofatumumab|Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
11156955|NCT01920477|OG001|Outcome|Placebo|Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
11156956|NCT01920477|EG000|Reported Event|Ofatumumab SC|Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
11156957|NCT01920477|EG001|Reported Event|Placebo|Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
11156958|NCT01920555|BG000|Baseline|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
11156959|NCT01920555|BG001|Baseline|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
11156960|NCT01920555|BG002|Baseline|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
11156961|NCT01920555|BG003|Baseline|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
11156962|NCT01920555|BG004|Baseline|Midazolam (Active Placebo)|"Patients in this arm will receive 0.045 mg/kg of midazolam - one single infusion~Placebo Midazolam: Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion"
11156963|NCT01920555|BG005|Baseline|Total|Total of all reporting groups
11156964|NCT01920555|FG000|Participant Flow|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
11156965|NCT01920555|FG001|Participant Flow|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
11156966|NCT01920555|FG002|Participant Flow|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
11156967|NCT01920555|FG003|Participant Flow|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
11156968|NCT01920555|FG004|Participant Flow|Midazolam (Active Placebo)|"Patients in this arm will receive 0.045 mg/kg of midazolam - one single infusion~Placebo Midazolam: Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion"
11156969|NCT01920555|OG000|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
11156970|NCT01920555|OG001|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
11156971|NCT01920555|OG002|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
11156972|NCT01920555|OG003|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
11156973|NCT01920555|OG004|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
11156974|NCT01920555|EG000|Reported Event|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
11156975|NCT01920555|EG001|Reported Event|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
11156976|NCT01920555|EG002|Reported Event|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
11156977|NCT01920555|EG003|Reported Event|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
11156978|NCT01920555|EG004|Reported Event|Midazolam (Active Placebo)|"Patients in this arm will receive 0.045 mg/kg of midazolam - one single infusion~Placebo Midazolam: Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion"
11156979|NCT01920568|BG000|Baseline|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
11156980|NCT01920568|BG001|Baseline|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
11156981|NCT01920568|BG002|Baseline|Total|Total of all reporting groups
11156982|NCT01920568|FG000|Participant Flow|Denosumab 120 mg|Participants received denosumab 120 milligrams (mg) as subcutaneous (SC) injection for a maximum of 13 doses and placebo as intravenous (IV) infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 international unit (IU) of vitamin D.
10851408|NCT00306202|OG005|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
11156983|NCT01920568|FG001|Participant Flow|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
11156984|NCT01920568|OG000|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
11156985|NCT01920568|OG001|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
11156986|NCT01920568|OG000|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
11156987|NCT01920568|EG000|Reported Event|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
11156988|NCT01920568|EG001|Reported Event|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
11156989|NCT01920594|BG000|Baseline|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
11156990|NCT01920594|BG001|Baseline|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
11156991|NCT01920594|BG002|Baseline|Total|Total of all reporting groups
11156992|NCT01920594|FG000|Participant Flow|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 milligrams (mg) on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg once daily (QD) for 4 days starting from Day 0 (surgical day).
11156993|NCT01920594|FG001|Participant Flow|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
11156994|NCT01920594|OG000|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
11156995|NCT01920594|OG001|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
11156996|NCT01920594|EG000|Reported Event|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
11156997|NCT01920594|EG001|Reported Event|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
11156998|NCT01920711|BG000|Baseline|LCZ696|Single Blind Run-in Period (3-8 weeks): Prior optional valsartan run-in 40 mg bid for 1-2 weeks for some patients followed by Valsartan 80 mg bid for 1-2 weeks followed by LCZ696 100 mg bid for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients could only be randomized from the run-in period if they met all of the run-in safety criteria. Target dose of LCZ696 during the double blind period was 200 mg bid
11156999|NCT01920711|BG001|Baseline|Valsartan|Single Blind Run-in Period (3-8 weeks): Prior optional valsartan run-in 40 mg bid for 1-2 weeks for some patients, followed by Valsartan 80 mg bid. for 1-2 weeks followed by LCZ696 100 mg bid for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients could only be randomized from the run-in period if they met all of the run-in safety criteria. Target dose of Valsartan during the double blind period was 160 mg bid
11157000|NCT01920711|BG002|Baseline|Total|Total of all reporting groups
11157001|NCT01920711|FG000|Participant Flow|LCZ696|Single Blind Run-in Period (3-8 weeks): Prior optional valsartan run-in 40 mg bid for 1-2 weeks for some patients followed by Valsartan 80 mg bid for 1-2 weeks followed by LCZ696 100 mg bid for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients could only be randomized from the run-in period if they met all of the run-in safety criteria. Target dose of LCZ696 during the double blind period was 200 mg bid
11157002|NCT01920711|FG001|Participant Flow|Valsartan|Single Blind Run-in Period (3-8 weeks): Prior optional valsartan run-in 40 mg bid for 1-2 weeks for some patients, followed by Valsartan 80 mg bid. for 1-2 weeks followed by LCZ696 100 mg bid for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients could only be randomized from the run-in period if they met all of the run-in safety criteria. Target dose of Valsartan during the double blind period was 160 mg bid
11157003|NCT01920711|OG000|Outcome|LCZ696|Single Blind Run-in Period (3-8 weeks): Prior optional valsartan run-in 40 mg bid for 1-2 weeks for some patients followed by Valsartan 80 mg bid for 1-2 weeks followed by LCZ696 100 mg bid for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients could only be randomized from the run-in period if they met all of the run-in safety criteria. Target dose of LCZ696 during the double blind period was 200 mg bid
11157004|NCT01920711|OG001|Outcome|Valsartan|Single Blind Run-in Period (3-8 weeks): Prior optional valsartan run-in 40 mg bid for 1-2 weeks for some patients, followed by Valsartan 80 mg bid. for 1-2 weeks followed by LCZ696 100 mg bid for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients could only be randomized from the run-in period if they met all of the run-in safety criteria. Target dose of Valsartan during the double blind period was 160 mg bid
11157005|NCT01920711|EG000|Reported Event|LCZ696|Single Blind Run-in Period (3-8 weeks): Prior optional valsartan run-in 40 mg bid for 1-2 weeks for some patients followed by Valsartan 80 mg bid for 1-2 weeks followed by LCZ696 100 mg bid for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients could only be randomized from the run-in period if they met all of the run-in safety criteria. Target dose of LCZ696 during the double blind period was 200 mg bid
11173904|NCT02018822|OG002|Outcome|Participants That Completed Esthet-X Intervention|light cured resin composite for teeth made by Dentsply Caulk
11157006|NCT01920711|EG001|Reported Event|Valsartan|Single Blind Run-in Period (3-8 weeks): Prior optional valsartan run-in 40 mg bid for 1-2 weeks for some patients, followed by Valsartan 80 mg bid. for 1-2 weeks followed by LCZ696 100 mg bid for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients could only be randomized from the run-in period if they met all of the run-in safety criteria. Target dose of Valsartan during the double blind period was 160 mg bid
11157007|NCT01920711|EG002|Reported Event|All Patients|Total patients
11157008|NCT01920802|BG000|Baseline|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
11157009|NCT01920802|BG001|Baseline|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
11157010|NCT01920802|BG002|Baseline|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
11157011|NCT01920802|BG003|Baseline|Total|Total of all reporting groups
11157012|NCT01920802|FG000|Participant Flow|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
11157013|NCT01920802|FG001|Participant Flow|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
11157014|NCT01920802|FG002|Participant Flow|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
11157015|NCT01920802|OG000|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
11157016|NCT01920802|OG001|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
11157017|NCT01920802|OG002|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
11157018|NCT01920802|EG000|Reported Event|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
11157019|NCT01920802|EG001|Reported Event|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
11157020|NCT01920802|EG002|Reported Event|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
11157021|NCT01920854|BG000|Baseline|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
11157022|NCT01920854|BG001|Baseline|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
11157023|NCT01920854|BG002|Baseline|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
11157024|NCT01920854|BG003|Baseline|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
11157025|NCT01920854|BG004|Baseline|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
11157026|NCT01920854|BG005|Baseline|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
11157027|NCT01920854|BG006|Baseline|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
11157028|NCT01920854|BG007|Baseline|Total|Total of all reporting groups
11157029|NCT01920854|FG000|Participant Flow|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
11157030|NCT01920854|FG001|Participant Flow|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
11157031|NCT01920854|FG002|Participant Flow|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
11157032|NCT01920854|FG003|Participant Flow|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
11157033|NCT01920854|FG004|Participant Flow|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
11173905|NCT02018822|EG000|Reported Event|UDMA|Experimental urethane dimethacrylate resin based composite resin for teeth used with prime an Bond Elect bonding agent
11228188|NCT02388724|BG001|Baseline|Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
11228189|NCT02388724|BG002|Baseline|Total|Total of all reporting groups
11228190|NCT02388724|FG000|Participant Flow|Vonoprazan 20 mg|Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
11228191|NCT02388724|FG001|Participant Flow|Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
11228192|NCT02388724|OG000|Outcome|Vonoprazan 20 mg|Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
11228193|NCT02388724|OG001|Outcome|Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
11228194|NCT02388724|EG000|Reported Event|Vonoprazan 20 mg|Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
11228195|NCT02388724|EG001|Reported Event|Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
11228196|NCT02388737|BG000|Baseline|Vonoprazan 10 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228197|NCT02388737|BG001|Baseline|Vonoprazan 20 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228198|NCT02388737|BG002|Baseline|Lansoprazole 15 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228199|NCT02388737|BG003|Baseline|Total|Total of all reporting groups
11228200|NCT02388737|FG000|Participant Flow|Vonoprazan 10 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228201|NCT02388737|FG001|Participant Flow|Vonoprazan 20 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228202|NCT02388737|FG002|Participant Flow|Lansoprazole 15 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228203|NCT02388737|OG000|Outcome|Vonoprazan 10 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228204|NCT02388737|OG001|Outcome|Vonoprazan 20 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228205|NCT02388737|OG002|Outcome|Lansoprazole 15 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11228206|NCT02388737|EG000|Reported Event|Vonoprazan 10 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11233846|NCT02431273|EG002|Reported Event|TDF-FTC-MVC (Triple IVR)|"If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with Triple (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.~TDF-FTC-MVC IVR"
11157034|NCT01920854|FG005|Participant Flow|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
11157035|NCT01920854|FG006|Participant Flow|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
11157036|NCT01920854|OG000|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
11157037|NCT01920854|OG001|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
11157038|NCT01920854|OG002|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
11157039|NCT01920854|OG003|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
11157040|NCT01920854|OG004|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
11157041|NCT01920854|OG000|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
11157042|NCT01920854|OG001|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
11157043|NCT01920854|OG002|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
11157044|NCT01920854|OG000|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
11157045|NCT01920854|OG001|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
11157046|NCT01920854|OG002|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
11157047|NCT01920854|OG003|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
11157048|NCT01920854|OG004|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
11157049|NCT01920854|OG005|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
11157050|NCT01920854|OG006|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
11157051|NCT01920854|OG007|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
11173906|NCT02018822|EG001|Reported Event|TPH3|Light-cured resin composite for teeth
11173907|NCT02018822|EG002|Reported Event|Esthet-X HD|Light cured resin composite for teeth made by Dentsply Caulk
11157052|NCT01920854|OG000|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
11157053|NCT01920854|OG001|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
11157054|NCT01920854|OG002|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
11157055|NCT01920854|OG003|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
11157056|NCT01920854|OG004|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
11157057|NCT01920854|OG005|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
11157058|NCT01920854|OG000|Outcome|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
11157059|NCT01920854|OG004|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
11157060|NCT01920854|OG005|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
11157061|NCT01920854|OG006|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
11157062|NCT01920854|EG000|Reported Event|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
11157063|NCT01920854|EG001|Reported Event|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
11157064|NCT01920854|EG002|Reported Event|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
11157065|NCT01920854|EG003|Reported Event|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
11157066|NCT01920854|EG004|Reported Event|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
11157067|NCT01920854|EG005|Reported Event|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
11157068|NCT01920854|EG006|Reported Event|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
11157069|NCT01920893|BG000|Baseline|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
11157070|NCT01920893|BG001|Baseline|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
11157071|NCT01920893|BG002|Baseline|Total|Total of all reporting groups
11157072|NCT01920893|FG000|Participant Flow|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to MFNS.
11157073|NCT01920893|FG001|Participant Flow|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
11157074|NCT01920893|OG000|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
11157075|NCT01920893|OG001|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
11157076|NCT01920893|OG001|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection every week from Week 1 to 15 added to MFNS.
11157077|NCT01920893|EG000|Reported Event|Placebo|Participants exposed to placebo (for dupilumab) added to MFNS (mean exposure of 14 weeks).
11157078|NCT01920893|EG001|Reported Event|Dupilumab 300 mg QW|Participants exposed to dupilumab added to MFNS (mean exposure of 16 weeks).
11157079|NCT01920958|BG000|Baseline|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
11157080|NCT01920958|FG000|Participant Flow|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
11157081|NCT01920958|OG000|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
11157082|NCT01920958|EG000|Reported Event|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
11157083|NCT01921101|BG000|Baseline|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
11157084|NCT01921101|BG001|Baseline|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
11157085|NCT01921101|BG002|Baseline|Total|Total of all reporting groups
11157086|NCT01921101|FG000|Participant Flow|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
11157087|NCT01921101|FG001|Participant Flow|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
11157088|NCT01921101|OG000|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
11157089|NCT01921101|OG001|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
11157090|NCT01921101|EG000|Reported Event|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
11157091|NCT01921101|EG001|Reported Event|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
11157092|NCT01921179|BG000|Baseline|GOALS (Goal-Oriented Attentional Regulation)|"Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice.~Participants randomized to GOALS intervention, did no receive EDU training after completion of GOALS."
11157093|NCT01921179|BG001|Baseline|EDU (Brain Health Education)|"Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training , 3 hours of individual training ,and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework.~Some subjects who completed EDU training during the randomized phase, completed additional 5 weeks of GOALS training."
11157094|NCT01921179|BG002|Baseline|Total|Total of all reporting groups
11157095|NCT01921179|FG000|Participant Flow|GOALS (Goal-Oriented Attentional Regulation)|Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
11157096|NCT01921179|FG001|Participant Flow|EDU (Brain Health Education)|Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
11157097|NCT01921179|OG000|Outcome|GOALS (Goal-Oriented Attentional Regulation)|"Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals.~Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS."
11233847|NCT02431299|BG000|Baseline|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
11157098|NCT01921179|OG001|Outcome|EDU (Brain Health Education)|"Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework.~Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training."
11157099|NCT01921179|OG000|Outcome|GOALS (Goal-Oriented Attentional Regulation)|Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
11157100|NCT01921179|EG000|Reported Event|GOALS (Goal-Oriented Attentional Regulation)|Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
11157101|NCT01921179|EG001|Reported Event|EDU (Brain Health Education)|"Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training , 3 hours of individual training ,and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework.~Some subjects who completed EDU training during the randomized phase, completed the additional 5 weeks of GOALS."
11157102|NCT01921205|BG000|Baseline|Placebo|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
11157103|NCT01921205|BG001|Baseline|Lacosamide|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
10887745|NCT00502593|OG004|Outcome|GSK1562902A-C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157104|NCT01921205|BG002|Baseline|Total Title|
11157105|NCT01921205|FG000|Participant Flow|Placebo|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
11157106|NCT01921205|FG001|Participant Flow|Lacosamide|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
11157107|NCT01921205|OG000|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
11157108|NCT01921205|OG001|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
11157109|NCT01921205|EG000|Reported Event|Placebo|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
11157110|NCT01921205|EG001|Reported Event|Lacosamide|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
11157111|NCT01921257|BG000|Baseline|Study Participants|Overall study participants
11157112|NCT01921257|FG000|Participant Flow|Placebo run-in Followed by Cat-PAD|All participants; received two intradermal doses of placebo (saline) followed by eight intradermal administrations of Cat-PAD.
11157113|NCT01921257|OG000|Outcome|Study Participants|Overall study participants
11157114|NCT01921257|EG000|Reported Event|Placebo run-in|Placebo run-in
11157115|NCT01921257|EG001|Reported Event|Cat-PAD|Active treatment (Cat-PAD)
11157116|NCT01921270|BG000|Baseline|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections.~Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
11157117|NCT01921270|FG000|Participant Flow|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
11157118|NCT01921270|OG000|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
11157119|NCT01921270|EG000|Reported Event|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
11157120|NCT01921296|BG000|Baseline|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
11157121|NCT01921296|FG000|Participant Flow|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
10887746|NCT00502593|OG005|Outcome|Fluarix-C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157122|NCT01921296|OG000|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
11157123|NCT01921296|EG000|Reported Event|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
11157124|NCT01921322|BG000|Baseline|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
11157125|NCT01921322|BG001|Baseline|Multiple Daily Injections|Multiple daily insulin injections used for treatment
11157126|NCT01921322|BG002|Baseline|Total|Total of all reporting groups
11157127|NCT01921322|FG000|Participant Flow|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
11157128|NCT01921322|FG001|Participant Flow|Multiple Daily Injections|Multiple daily insulin injections used for treatment
11157129|NCT01921322|OG000|Outcome|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
11157130|NCT01921322|OG001|Outcome|Multiple Daily Injections|Multiple daily insulin injections used for treatment
11157131|NCT01921322|EG000|Reported Event|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
11157132|NCT01921322|EG001|Reported Event|Multiple Daily Injections|Multiple daily insulin injections used for treatment
11157133|NCT01921348|BG000|Baseline|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
11157134|NCT01921348|BG001|Baseline|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
11157135|NCT01921348|BG002|Baseline|Total|Total of all reporting groups
11233848|NCT02431299|BG001|Baseline|IMR Clinicians|Clinicians who provided the IMR intervention to the IMR Consumers
11157136|NCT01921348|FG000|Participant Flow|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
11157137|NCT01921348|FG001|Participant Flow|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
11157138|NCT01921348|OG000|Outcome|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
11157139|NCT01921348|OG001|Outcome|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
11157140|NCT01921348|EG000|Reported Event|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
11157141|NCT01921348|EG001|Reported Event|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
11157142|NCT01921387|BG000|Baseline|Treatment (90Y-BC8-DOTA, Chemotherapy, PBSC)|"Patients receive yttrium Y 90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients also receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours BID on days -6 to -3, cytarabine IV over 4 hours BID on days -6 to -3, and melphalan IV over 30 minutes on day -2. Patients then undergo autologous PBSC transplant on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSC transplant~Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8: Given IV"
11157143|NCT01921387|FG000|Participant Flow|Treatment (90Y-BC8-DOTA, Chemotherapy, PBSC)|"Patients receive yttrium Y 90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients also receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours BID on days -6 to -3, cytarabine IV over 4 hours BID on days -6 to -3, and melphalan IV over 30 minutes on day -2. Patients then undergo autologous PBSC transplant on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSC transplant~Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8: Given IV"
11157144|NCT01921387|OG000|Outcome|Treatment (90Y-BC8-DOTA, Chemotherapy, PBSC)|"Patients receive yttrium Y 90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients also receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours BID on days -6 to -3, cytarabine IV over 4 hours BID on days -6 to -3, and melphalan IV over 30 minutes on day -2. Patients then undergo autologous PBSC transplant on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSC transplant~Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8: Given IV"
11157145|NCT01921387|EG000|Reported Event|Treatment (90Y-BC8-DOTA, Chemotherapy, PBSC)|"Patients receive yttrium Y 90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients also receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours BID on days -6 to -3, cytarabine IV over 4 hours BID on days -6 to -3, and melphalan IV over 30 minutes on day -2. Patients then undergo autologous PBSC transplant on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSC transplant~Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8: Given IV"
11157146|NCT01921452|BG000|Baseline|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
11157147|NCT01921452|FG000|Participant Flow|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
11157148|NCT01921452|OG000|Outcome|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
11157149|NCT01921452|OG000|Outcome|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
11157150|NCT01921452|EG000|Reported Event|POC TSH Kit + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
11157151|NCT01921517|BG000|Baseline|Low Magnitude Mechanical Stimulation|"10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.~Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g."
11157152|NCT01921517|BG001|Baseline|Sham Low Magnitude Mechanical Stimulation|"10 minutes daily of placebo treatment using a sham vibrating platform.~Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device."
11157153|NCT01921517|BG002|Baseline|Total|Total of all reporting groups
11157154|NCT01921517|FG000|Participant Flow|Low Magnitude Mechanical Stimulation|"10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.~Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g."
11157155|NCT01921517|FG001|Participant Flow|Sham Low Magnitude Mechanical Stimulation|"10 minutes daily of placebo treatment using a sham vibrating platform.~Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device."
11233849|NCT02431299|BG002|Baseline|Total|Total of all reporting groups
11157156|NCT01921517|OG000|Outcome|Low Magnitude Mechanical Stimulation|"10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.~Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g."
11157157|NCT01921517|OG001|Outcome|Sham Low Magnitude Mechanical Stimulation|"10 minutes daily of placebo treatment using a sham vibrating platform.~Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device."
11157158|NCT01921517|EG000|Reported Event|Low Magnitude Mechanical Stimulation|"10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.~Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g."
11157159|NCT01921517|EG001|Reported Event|Sham Low Magnitude Mechanical Stimulation|"10 minutes daily of placebo treatment using a sham vibrating platform.~Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device."
11157160|NCT01921634|BG000|Baseline|Women Undergoing Appendectomy|Women undergoing coincidental appendectomy at time of primary gynecological procedure
11157161|NCT01921634|FG000|Participant Flow|Women Undergoing Appendectomy|Women undergoing coincidental appendectomy at time of primary gynecological procedure
11157162|NCT01921634|OG000|Outcome|Standard Analysis|Standard pathological analysis currently used.
11157163|NCT01921634|OG001|Outcome|Modified Pathologic Analysis|After undergoing standard pathologic analysis, each specimen undergoes the modified pathologic analysis.
11157164|NCT01921634|EG000|Reported Event|Women Undergoing Appendectomy|Women undergoing coincidental appendectomy at time of primary gynecological procedure
11157165|NCT01921751|BG000|Baseline|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
11157166|NCT01921751|BG001|Baseline|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
11157167|NCT01921751|BG002|Baseline|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
11157168|NCT01921751|BG003|Baseline|Total|Total of all reporting groups
11157169|NCT01921751|FG000|Participant Flow|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
11157170|NCT01921751|FG001|Participant Flow|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
11157171|NCT01921751|FG002|Participant Flow|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
11157172|NCT01921751|OG000|Outcome|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
11157173|NCT01921751|OG001|Outcome|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
11157174|NCT01921751|OG002|Outcome|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
11157175|NCT01921751|EG000|Reported Event|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
11157176|NCT01921751|EG001|Reported Event|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
11157177|NCT01921751|EG002|Reported Event|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
11157178|NCT01921751|EG003|Reported Event|Chemotherapy - Not Randomized|Induction chemotherapy with three cycles of gemcitabine and nab-paclitaxel [not randomized]
11157179|NCT01921829|BG000|Baseline|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
11157180|NCT01921829|BG001|Baseline|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
11157181|NCT01921829|BG002|Baseline|Total|Total of all reporting groups
11157182|NCT01921829|FG000|Participant Flow|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
11157183|NCT01921829|FG001|Participant Flow|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
11157184|NCT01921829|OG000|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
11157185|NCT01921829|OG001|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
11157186|NCT01921829|EG000|Reported Event|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
11157187|NCT01921829|EG001|Reported Event|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
11157188|NCT01921894|BG000|Baseline|Cholecalciferol 4000 IU|Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
11157189|NCT01921894|BG001|Baseline|Cholecalciferol 2000 IU|Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
11157190|NCT01921894|BG002|Baseline|Cholecalciferol 200 IU|Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
11157191|NCT01921894|BG003|Baseline|Total|Total of all reporting groups
11157192|NCT01921894|FG000|Participant Flow|Cholecalciferol 4000 IU|"Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
11157193|NCT01921894|FG001|Participant Flow|Cholecalciferol 2000 IU|"Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
11157194|NCT01921894|FG002|Participant Flow|Cholecalciferol 200 IU|"Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
11157195|NCT01921894|OG000|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
11157196|NCT01921894|OG001|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
11157197|NCT01921894|OG002|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
11157198|NCT01921894|OG000|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
11157199|NCT01921894|OG001|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
11157200|NCT01921894|OG002|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
11157201|NCT01921894|OG000|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
11157202|NCT01921894|OG001|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
11157203|NCT01921894|OG002|Outcome|Cholecalciferol 200 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
11157204|NCT01921894|OG000|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
11157205|NCT01921894|OG001|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
11157206|NCT01921894|OG002|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
11157207|NCT01921894|OG000|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
11157208|NCT01921894|OG001|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
11157209|NCT01921894|OG002|Outcome|Cholecalciferol 200 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
11157210|NCT01921894|EG000|Reported Event|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome includes any report of adverse events.
11157211|NCT01921894|EG001|Reported Event|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome includes any report of adverse events.
11157212|NCT01921894|EG002|Reported Event|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome includes any report of adverse events.
11157213|NCT01922011|BG000|Baseline|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
11157214|NCT01922011|BG001|Baseline|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
11157215|NCT01922011|BG002|Baseline|Total|Total of all reporting groups
11157216|NCT01922011|FG000|Participant Flow|Daptomycin|Intravenous (IV) daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
11157217|NCT01922011|FG001|Participant Flow|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg every six hours (q6h), or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
11157218|NCT01922011|OG000|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
11157219|NCT01922011|OG001|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
11157220|NCT01922011|OG000|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
11157221|NCT01922011|OG000|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
11157222|NCT01922011|OG001|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
11157223|NCT01922011|OG002|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9 mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
11157224|NCT01922011|OG003|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
11157225|NCT01922011|OG002|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9, mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
11157226|NCT01922011|EG000|Reported Event|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
11157227|NCT01922011|EG001|Reported Event|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
11157228|NCT01922024|BG000|Baseline|Prospective Fresh Clinical Specimens|"Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against composite (comparator) which is based on routine clinical microbiology and a second PCR test~LRT55 Testing: Testing on the Unyvero LRT55"
11157229|NCT01922024|BG001|Baseline|Retrospective Frozen Clinical Specimens|"Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology~LRT55 Testing: Testing on the Unyvero LRT55"
11157230|NCT01922024|BG002|Baseline|Total|Total of all reporting groups
10887747|NCT00502593|OG000|Outcome|GSK1562902A-A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157231|NCT01922024|FG000|Participant Flow|Prospective Fresh Clinical Specimens|"Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against composite (comparator) which is based on routine clinical microbiology and a second PCR test~LRT55 Testing: Testing on the Unyvero LRT55"
11157232|NCT01922024|FG001|Participant Flow|Retrospective Frozen Clinical Specimens|"Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology~LRT55 Testing: Testing on the Unyvero LRT55"
11157233|NCT01922024|OG000|Outcome|Prospective Fresh Clinical Specimens|"Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against composite (comparator) which is based on routine clinical microbiology and a second PCR test~LRT55 Testing: Testing on the Unyvero LRT55~an overall weighted average sensitivity of 91.4% for detection of panel pathogens an overall weighted average specificity of 99.5% for detection of panel pathogens~an overall weighted average sensitivity of 89.9 % for detection of resistance markers an overall weighted average specificity of 99.3 % for detection of resistance markers"
11157234|NCT01922024|OG001|Outcome|Retrospective Frozen Clinical Specimens|"Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology~LRT55 Testing: Testing on the Unyvero LRT55~an overall weighted average sensitivity of 91.4% for detection of panel pathogens an overall weighted average specificity of 99.5% for detection of panel pathogens~an overall weighted average sensitivity of 89.9 % for detection of resistance markers an overall weighted average specificity of 99.3 % for detection of resistance markers"
11157235|NCT01922024|EG000|Reported Event|Prospective Fresh Clinical Specimens|"Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against composite (comparator) which is based on routine clinical microbiology and a second PCR test~LRT55 Testing: Testing on the Unyvero LRT55"
11157236|NCT01922024|EG001|Reported Event|Retrospective Frozen Clinical Specimens|"Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology~LRT55 Testing: Testing on the Unyvero LRT55"
11233850|NCT02431299|FG000|Participant Flow|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
11157237|NCT01922037|BG000|Baseline|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157238|NCT01922037|BG001|Baseline|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157239|NCT01922037|BG002|Baseline|Total|Total of all reporting groups
11157240|NCT01922037|FG000|Participant Flow|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157241|NCT01922037|FG001|Participant Flow|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age greater than or equal to [>/=18] years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157242|NCT01922037|OG000|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157243|NCT01922037|OG001|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157244|NCT01922037|OG002|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157245|NCT01922037|EG000|Reported Event|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157246|NCT01922037|EG001|Reported Event|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157247|NCT01922037|EG002|Reported Event|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
11157248|NCT01922050|BG000|Baseline|Part 1: LEO 43204 Gel 0.0015|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
10887748|NCT00502593|OG001|Outcome|Fluarix-A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157249|NCT01922050|BG001|Baseline|Part 1: LEO 43204 Gel 0.003|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157250|NCT01922050|BG002|Baseline|Part 1: LEO 43204 Gel 0.006|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157251|NCT01922050|BG003|Baseline|Part 1: LEO 43204 Gel 0.012|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157252|NCT01922050|BG004|Baseline|Part 1: LEO 43204 Gel 0.018|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157253|NCT01922050|BG005|Baseline|Part 1: LEO 43204 Gel 0.025|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157254|NCT01922050|BG006|Baseline|Part 1: LEO 43204 Cream 0.0015|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157255|NCT01922050|BG007|Baseline|Part 1: LEO 43204 Cream 0.003|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157256|NCT01922050|BG008|Baseline|Part 1: LEO 43204 Cream 0.006|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157257|NCT01922050|BG009|Baseline|Part 1: LEO 43204 Cream 0.012|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157258|NCT01922050|BG010|Baseline|Part 2: LEO 43204 Gel Vehicle|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157259|NCT01922050|BG011|Baseline|Part 2: LEO 43204 Gel 0.006|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157260|NCT01922050|BG012|Baseline|Part 2: LEO 43204 Gel 0.012|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157261|NCT01922050|BG013|Baseline|Part 2: LEO 43204 Gel 0.018|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157262|NCT01922050|BG014|Baseline|Total|Total of all reporting groups
11157263|NCT01922050|FG000|Participant Flow|Part 1: LEO 43204 Gel 0.0015|"Part 1: Dose-Escalation~LEO 43204 gel 0.0015% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157264|NCT01922050|FG001|Participant Flow|Part 1: LEO 43204 Gel 0.003|"Part 1: Dose-Escalation~LEO 43204 gel 0.003% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157265|NCT01922050|FG002|Participant Flow|Part 1: LEO 43204 Gel 0.006|"Part 1: Dose-Escalation~LEO 43204 gel 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157266|NCT01922050|FG003|Participant Flow|Part 1: LEO 43204 Gel 0.012|"Part 1: Dose-Escalation~LEO 43204 gel 0.012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157267|NCT01922050|FG004|Participant Flow|Part 1: LEO 43204 Gel 0.018|"Part 1: Dose-Escalation~LEO 43204 gel 0.018% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157268|NCT01922050|FG005|Participant Flow|Part 1: LEO 43204 Gel 0.025|"Part 1: Dose-Escalation~LEO 43204 gel 0.025% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11233851|NCT02431299|FG001|Participant Flow|IMR Clinicians|The clinicians who provided IMR intervention to the IMR Consumers
11157269|NCT01922050|FG006|Participant Flow|Part 1: LEO 43204 Cream 0.0015|"Part 1: Dose-Escalation~LEO 43204 cream 0.0015% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157270|NCT01922050|FG007|Participant Flow|Part 1: LEO 43204 Cream 0.003|"Part 1: Dose-Escalation~LEO 43204 cream 0.003% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157271|NCT01922050|FG008|Participant Flow|Part 1: LEO 43204 Cream 0.006|"Part 1: Dose-Escalation~LEO 43204 cream 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157272|NCT01922050|FG009|Participant Flow|Part 1: LEO 43204 Cream 0.012|"Part 1: Dose-Escalation~LEO 43204 cream 0.0012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest."
11157273|NCT01922050|FG010|Participant Flow|Part 2: LEO 43204 Gel 0.006|"Part 2: Double-Blind phase~LEO 43204 gel 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home."
11157274|NCT01922050|FG011|Participant Flow|Part 2: LEO 43204 Gel 0.012|Part 2: Double-Blind phase LEO 43204 gel 0.012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.
11157275|NCT01922050|FG012|Participant Flow|Part 2: LEO 43204 Gel 0.018|Part 2: Double-Blind phase LEO 43204 gel 0.018% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.
11157276|NCT01922050|FG013|Participant Flow|Part 2: LEO 43204 Gel Vehicle|Part 2: Double-Blind phase LEO 43204 gel vehicle applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.
11157277|NCT01922050|OG000|Outcome|Part 1: Cohort 1: LEO 43204 Gel 0.0015|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157278|NCT01922050|OG001|Outcome|Part 1: Cohort 2: LEO 43204 Gel 0.003|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157279|NCT01922050|OG002|Outcome|Part 1: Cohort 3: LEO 43204 Gel 0.006|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157280|NCT01922050|OG003|Outcome|Part 1: Cohort 4: LEO 43204 Gel 0.012|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157281|NCT01922050|OG004|Outcome|Part 1: Cohort 5: LEO 43204 Gel 0.018|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157282|NCT01922050|OG005|Outcome|Part 1: Cohort 6: LEO 43204 Gel 0.025|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157283|NCT01922050|OG006|Outcome|Part 1: Cohort 1: LEO 43204 Cream 0.0015|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157284|NCT01922050|OG007|Outcome|Part 1: Cohort 2: LEO 43204 Cream 0.003|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157285|NCT01922050|OG008|Outcome|Part 1: Cohort 3: LEO 43204 Cream 0.006|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157286|NCT01922050|OG009|Outcome|Part 1: Cohort 4: LEO 43204 Cream 0.012|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157287|NCT01922050|OG000|Outcome|Part 2: LEO 43204 Gel Vehicle|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157288|NCT01922050|OG001|Outcome|Part 2: LEO 43204 Gel 0.006|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157289|NCT01922050|OG002|Outcome|Part 2: LEO 43204 Gel 0.012|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157290|NCT01922050|OG003|Outcome|Part 2: LEO 43204 Gel 0.018|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157291|NCT01922050|EG000|Reported Event|Part 1: LEO 43204 Gel 0.0015|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157292|NCT01922050|EG001|Reported Event|Part 1: LEO 43204 Gel 0.003|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157293|NCT01922050|EG002|Reported Event|Part 1: LEO 43204 Gel 0.006|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157294|NCT01922050|EG003|Reported Event|Part 1: LEO 43204 Gel 0.012|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157295|NCT01922050|EG004|Reported Event|Part 1: LEO 43204 Gel 0.018|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157296|NCT01922050|EG005|Reported Event|Part 1: LEO 43204 Gel 0.025|Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
11157297|NCT01922050|EG006|Reported Event|Part 1: LEO 43204 Cream 0.0015|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157298|NCT01922050|EG007|Reported Event|Part 1: LEO 43204 Cream 0.003|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157299|NCT01922050|EG008|Reported Event|Part 1: LEO 43204 Cream 0.006|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157300|NCT01922050|EG009|Reported Event|Part 1: LEO 43204 Cream 0.012|Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
11157301|NCT01922050|EG010|Reported Event|Part 2: LEO 43204 Gel Vehicle|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157302|NCT01922050|EG011|Reported Event|Part 2: LEO 43204 Gel 0.006|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157303|NCT01922050|EG012|Reported Event|Part 2: LEO 43204 Gel 0.012|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157304|NCT01922050|EG013|Reported Event|Part 2: LEO 43204 Gel 0.018|Part 2: Double-Blind, Once-Daily, 2-Day Treatment
11157305|NCT01922089|BG000|Baseline|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
11157306|NCT01922089|BG001|Baseline|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
11157307|NCT01922089|BG002|Baseline|Total|Total of all reporting groups
11157308|NCT01922089|FG000|Participant Flow|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
11157309|NCT01922089|FG001|Participant Flow|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
11157310|NCT01922089|OG000|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
11157311|NCT01922089|OG001|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
11157312|NCT01922089|EG000|Reported Event|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
11157313|NCT01922089|EG001|Reported Event|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
11157314|NCT01922102|BG000|Baseline|Group I|0.5 mg ranibizumab driven by visual acuity stability criteria
11157315|NCT01922102|BG001|Baseline|Group II|0.5 mg ranibizumab driven by disease activity criteria
11157316|NCT01922102|BG002|Baseline|Group III|verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment
11157317|NCT01922102|BG003|Baseline|Total|Total of all reporting groups
11157318|NCT01922102|FG000|Participant Flow|Group I|0.5 mg ranibizumab driven by visual acuity stability criteria
10887749|NCT00502593|OG002|Outcome|GSK1562902A-B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157319|NCT01922102|FG001|Participant Flow|Group II|0.5 mg ranibizumab driven by disease activity criteria
11157320|NCT01922102|FG002|Participant Flow|Group III|verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment
11157321|NCT01922102|OG000|Outcome|Group I|0.5 mg ranibizumab driven by visual acuity stability criteria
11157322|NCT01922102|OG001|Outcome|Group II|0.5 mg ranibizumab driven by disease activity criteria
11157323|NCT01922102|OG002|Outcome|Group III|verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment
11157324|NCT01922102|OG002|Outcome|Group III|verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment.
11157325|NCT01922102|OG002|Outcome|Group III With 0.5mg Ranibizumab|verteporfin PDT with 0.5 mg ranibizumab from month 3
11157326|NCT01922102|OG003|Outcome|Group III Without 0.5mg Ranibizumab|verteporfin PDT without 0.5 mg ranibizumab from month 3
11157327|NCT01922102|EG000|Reported Event|Group I|0.5 mg ranibizumab driven by visual acuity stability criteria
11157328|NCT01922102|EG001|Reported Event|Group II|0.5 mg ranibizumab driven by disease activity criteria
11157329|NCT01922102|EG002|Reported Event|Group III With 0.5mg Ranibizumab|Visudyne PDT with 0.5mg ranibizumab from month 3
11157330|NCT01922102|EG003|Reported Event|Group III Without 0.5mg Ranibizumab|Visudyne PDT without 0.5mg ranibizumab from month 3
11157331|NCT01922115|BG000|Baseline|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
11157332|NCT01922115|BG001|Baseline|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
11157333|NCT01922115|BG002|Baseline|Total|Total of all reporting groups
11157334|NCT01922115|FG000|Participant Flow|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
11157335|NCT01922115|FG001|Participant Flow|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
11233852|NCT02431299|OG000|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
11233853|NCT02431299|OG000|Outcome|IMR Clinicians|Clinicians providing IMR to the IMR consumers.
11157336|NCT01922115|OG000|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
11157337|NCT01922115|OG001|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
11157338|NCT01922115|EG000|Reported Event|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
11157339|NCT01922115|EG001|Reported Event|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
11157340|NCT01922219|BG000|Baseline|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
11157341|NCT01922219|FG000|Participant Flow|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
11157342|NCT01922219|OG000|Outcome|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
11157343|NCT01922219|EG000|Reported Event|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
11157344|NCT01922258|BG000|Baseline|Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day)|Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
11157345|NCT01922258|BG001|Baseline|Placebo (Flexible Dose Range 0.5 to 2 mg/Day)|Titrate up from 0.25 mg/day placebo to 1 mg/day placebo. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
11157346|NCT01922258|BG002|Baseline|Total|Total of all reporting groups
11157347|NCT01922258|FG000|Participant Flow|Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day)|Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
11157348|NCT01922258|FG001|Participant Flow|Placebo (Flexible Dose Range 0.5 to 2 mg/Day)|Titrate up from 0.25 mg/day placebo to 1 mg/day placebo. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
11157349|NCT01922258|OG000|Outcome|Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day)|Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
11157350|NCT01922258|OG001|Outcome|Placebo (Flexible Dose Range 0.5 to 2 mg/Day)|Titrate up from 0.25 mg/day placebo to 1 mg/day placebo. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
11157351|NCT01922258|EG000|Reported Event|Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day)|Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
11157352|NCT01922258|EG001|Reported Event|Placebo (Flexible Dose Range 0.5 to 2 mg/Day)|Titrate up from 0.25 mg/day placebo to 1 mg/day placebo. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
11157353|NCT01922271|BG000|Baseline|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
11157354|NCT01922271|BG001|Baseline|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
11157355|NCT01922271|BG002|Baseline|Total|Total of all reporting groups
11157356|NCT01922271|FG000|Participant Flow|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
11157357|NCT01922271|FG001|Participant Flow|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
11157358|NCT01922271|OG000|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
11157359|NCT01922271|OG001|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
11157360|NCT01922271|EG000|Reported Event|NVA237|ALL patients on NVA237 for Period 1 & Period 2
11157361|NCT01922271|EG001|Reported Event|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
11157362|NCT01922336|BG000|Baseline|SB2 (Proposed Infliximab Biosimilar)|"SB2 (Study drug)~SB2: IV infusion"
11157363|NCT01922336|BG001|Baseline|EU Remicade|"EU sourced Remicade (Reference drug)~EU Remicade: IV infusion"
11157364|NCT01922336|BG002|Baseline|US Remicade|"US sourced Remicade (Reference drug)~US Remicade: IV infusion"
11157365|NCT01922336|BG003|Baseline|Total|Total of all reporting groups
11157366|NCT01922336|FG000|Participant Flow|SB2 (Proposed Infliximab Biosimilar)|"SB2 (Study drug)~SB2: IV infusion"
11157367|NCT01922336|FG001|Participant Flow|EU Remicade|"EU sourced Remicade (Reference drug)~EU Remicade: IV infusion"
11157368|NCT01922336|FG002|Participant Flow|US Remicade|"US sourced Remicade (Reference drug)~US Remicade: IV infusion"
11157369|NCT01922336|OG000|Outcome|SB2 (Proposed Infliximab Biosimilar)|"SB2 (Study drug)~SB2: IV infusion"
11157370|NCT01922336|OG001|Outcome|EU Remicade|"EU sourced Remicade (Reference drug)~EU Remicade: IV infusion"
11157371|NCT01922336|OG002|Outcome|US Remicade|"US sourced Remicade (Reference drug)~US Remicade: IV infusion"
11157372|NCT01922336|EG000|Reported Event|SB2 (Proposed Infliximab Biosimilar)|"SB2 (Study drug)~SB2: IV infusion"
11157373|NCT01922336|EG001|Reported Event|EU Remicade|"EU sourced Remicade (Reference drug)~EU Remicade: IV infusion"
11157374|NCT01922336|EG002|Reported Event|US Remicade|"US sourced Remicade (Reference drug)~US Remicade: IV infusion"
11173908|NCT02018887|BG000|Baseline|Part A: Cohorts 1-2|Part A Single Ascending Dose (SAD): Cohort 1 received placebo, 2 mg, 20 mg, or 40 mg LY2969822 PO, once, in each of 3 study periods. Cohort 2 received placebo, 6 mg, 60 mg, or 20 mg LY2969822 PO, once, in each of 3 study periods. At least 5 days elapsed between doses of study drug.
11174307|NCT02020785|OG001|Outcome|Lower Phosphorus Period|"Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks~At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives.~Patients then randomized to higher phosphorus period or lower phosphorus period first.~Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) given for 3 weeks~Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks"
11157375|NCT01922349|BG000|Baseline|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157376|NCT01922349|BG001|Baseline|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157377|NCT01922349|BG002|Baseline|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157378|NCT01922349|BG003|Baseline|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157379|NCT01922349|BG004|Baseline|Total|Total of all reporting groups
11157380|NCT01922349|FG000|Participant Flow|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (Multiple rising dose (MRD) period)
11157381|NCT01922349|FG001|Participant Flow|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157382|NCT01922349|FG002|Participant Flow|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157383|NCT01922349|FG003|Participant Flow|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157384|NCT01922349|OG000|Outcome|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157385|NCT01922349|OG001|Outcome|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11349174|NCT04115358|OG001|Outcome|Formocresol|"0,1 ml to the orifice of the root canals of the primary molar~Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material."
11157386|NCT01922349|OG002|Outcome|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157387|NCT01922349|OG003|Outcome|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
11157388|NCT01922349|OG000|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
10851409|NCT00306202|OG000|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
11157389|NCT01922349|OG001|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
11157390|NCT01922349|OG002|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
11157391|NCT01922349|OG003|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
11157392|NCT01922349|OG004|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
11157393|NCT01922349|OG005|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
11157394|NCT01922349|OG006|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
11157395|NCT01922349|OG007|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
11157396|NCT01922349|OG000|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
11157397|NCT01922349|OG001|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
11157398|NCT01922349|OG002|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
11157399|NCT01922349|OG003|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
11157400|NCT01922349|OG004|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
11157401|NCT01922349|OG005|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
11157402|NCT01922349|OG006|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
11157403|NCT01922349|OG007|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
11157404|NCT01922349|OG000|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 days in Chinese subjects (MRD period)
11157405|NCT01922349|EG000|Reported Event|Placebo- Chinese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
11157406|NCT01922349|EG001|Reported Event|Placebo- Japanese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
11157407|NCT01922349|EG002|Reported Event|Placebo- Caucasian|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
11157408|NCT01922349|EG003|Reported Event|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 days (MRD period) in Chinese subjects
11157409|NCT01922349|EG004|Reported Event|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
11157410|NCT01922349|EG005|Reported Event|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
11157411|NCT01922349|EG006|Reported Event|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
11157412|NCT01922349|EG007|Reported Event|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
11157413|NCT01922349|EG008|Reported Event|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
11157414|NCT01922349|EG009|Reported Event|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
11157415|NCT01922349|EG010|Reported Event|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
11157416|NCT01922739|BG000|Baseline|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
11157417|NCT01922739|BG001|Baseline|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
11157418|NCT01922739|BG002|Baseline|Total|Total of all reporting groups
11157419|NCT01922739|FG000|Participant Flow|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
11157420|NCT01922739|OG000|Outcome|Placebo: Double-Blind Titration Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks."
11157421|NCT01922739|OG001|Outcome|Hydrocodone ER: Double-Blind Titration Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks."
11157422|NCT01922739|OG002|Outcome|Placebo: Open-Label Adjustment Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks."
11157423|NCT01922739|OG003|Outcome|Hydrocodone ER: Open-Label Adjustment Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks."
10851410|NCT00306202|OG001|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
11157424|NCT01922739|OG004|Outcome|Hydrocodone ER: Open-Label Treatment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
11157425|NCT01922739|OG000|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
11174308|NCT02020785|EG000|Reported Event|Higher Phosphorus Period|Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) given for 3 weeks
11157426|NCT01922739|OG000|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
11157427|NCT01922739|OG001|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
11157428|NCT01922739|OG002|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
11157429|NCT01922739|OG001|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
11157430|NCT01922739|OG002|Outcome|Hydrocodone ER|Participants were administered extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open label treatment period of 22 weeks.
11157431|NCT01922739|OG000|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
11157432|NCT01922739|EG000|Reported Event|Hydrocodone ER - Titration/Adjustment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. The titration/adjustment period lasted 3-4 weeks.
11157433|NCT01922739|EG001|Reported Event|Hydrocodone ER - Open-Label Treatment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Treatment Period lasted 22 weeks.
11157434|NCT01922934|BG000|Baseline|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
11157435|NCT01922934|BG001|Baseline|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period.
11157436|NCT01922934|BG002|Baseline|Total|Total of all reporting groups
11157437|NCT01922934|FG000|Participant Flow|Intervention|"428 randomly-selected patients from four Denver Health clinics are identified for the intervention arm which offers a toolbox of weight loss options. The toolbox includes: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes & entrees); and obesity pharmacotherapy (Qsymia & phentermine). At the initial assessment (visit 0), a computer program helps patients choose a personal treatment mode and they receive a starter kit with self-monitoring tools and meal replacements. Subjects must show self-monitoring of diet and exercise to receive more intensive therapies at their next visit (visit 1). At subsequent monthly visits, patients select a primary intensive therapy, but are able to add/change tools throughout the one year study period. Patients pay a $5-$10 co-pay for the therapies."
11157438|NCT01922934|FG001|Participant Flow|Control|"4302 Registry patients not selected to be offered the toolbox options will receive usual care for weight management. Usual care for obesity at DH includes brief weight loss advice provided by PCPs or prescribing of weight loss medication, for which patients pay out of pocket."
11157439|NCT01922934|OG000|Outcome|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool. Included in analysis if they had both baseline and 12 month weights available.
11157440|NCT01922934|OG001|Outcome|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period. Included in analysis if they had both baseline and 12 month weights available.
11157441|NCT01922934|OG000|Outcome|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
11157442|NCT01922934|OG001|Outcome|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period.
11157443|NCT01922934|OG000|Outcome|Random Sample of DHHA Registry Control Group|"We selected a random sample of 120 patients from the DHHA registry Control Group for a chart review. The dates used matched the study intervention period. Six reviewers, 3 MDs and 3 study personnel, reviewed medical records for the following:~Presence of ICD-9 code for obesity~Evidence that the the PCP discussed weight loss with the patient~Evidence of a specific intervention for weight management. Each record was evaluated by two reviewers, 1 MD and 1 study personnel ."
11174309|NCT02020785|EG001|Reported Event|Lower Phosphorus Period|Commercially-available unaltered food/beverage products without phosphorus additives (<10mg/d of phosphorus) given for 3 weeks
11157444|NCT01922934|EG000|Reported Event|Intervention|"428 randomly-selected patients from four Denver Health clinics were selected to be offered a toolbox of weight loss options, including: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes & entrees); and obesity pharmacotherapy (Qsymia & phentermine) for a $5-$10 co-pay for the therapies. Of these 428 patients, 140 came in and consented at the computer program visit at which these options were offered. 119 of these patients came in for a visit one where they received their tool for the first time. Adverse events from the group of 140 patients who consented to receive the intervention are reported."
11157445|NCT01922986|BG000|Baseline|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
11157446|NCT01922986|BG001|Baseline|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
11157447|NCT01922986|BG002|Baseline|Total|Total of all reporting groups
11157448|NCT01922986|FG000|Participant Flow|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
11157449|NCT01922986|FG001|Participant Flow|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
11157450|NCT01922986|OG000|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
11157451|NCT01922986|OG001|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
11157452|NCT01922986|EG000|Reported Event|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
11157453|NCT01922986|EG001|Reported Event|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
11157454|NCT01923129|BG000|Baseline|24 Hour Postop Catheter Removal|"group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)~Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)"
11157455|NCT01923129|BG001|Baseline|72 Hour Postoperative Catheter Removal|catheter removed on postoperative day 3 (72 hours postoperatively)
11157456|NCT01923129|BG002|Baseline|Total|Total of all reporting groups
11157457|NCT01923129|FG000|Participant Flow|24 Hour Postop Catheter Removal|"group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)~Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)"
11157458|NCT01923129|FG001|Participant Flow|72 Hour Postoperative Catheter Removal|catheter removed on postoperative day 3 (72 hours postoperatively)
11157459|NCT01923129|OG000|Outcome|24 Hour Postop Catheter Removal|"group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)~Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)"
11157460|NCT01923129|OG001|Outcome|72 Hour Postoperative Catheter Removal|catheter removed on postoperative day 3 (72 hours postoperatively)
11157461|NCT01923129|EG000|Reported Event|24 Hour Postop Catheter Removal|"group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)~Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)"
11157462|NCT01923129|EG001|Reported Event|72 Hour Postoperative Catheter Removal|catheter removed on postoperative day 3 (72 hours postoperatively)
11157463|NCT01923181|BG000|Baseline|Oral Semaglutide 2.5 mg|Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11233854|NCT02431299|EG000|Reported Event|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
11233855|NCT02431299|EG001|Reported Event|IMR Clinicians|Clinician participants who are providing Illness Management and Recovery (IMR) intervention.
11233856|NCT02431364|BG000|Baseline|Placebo|Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.
10851411|NCT00306202|OG002|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
11157464|NCT01923181|BG001|Baseline|Oral Semaglutide 5 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157465|NCT01923181|BG002|Baseline|Oral Semaglutide 10 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157466|NCT01923181|BG003|Baseline|Oral Semaglutide 20 mg|"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.~Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets."
11157467|NCT01923181|BG004|Baseline|Oral Semaglutide 40 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157468|NCT01923181|BG005|Baseline|Oral Semaglutide 40 mg Slow Dose-escalation|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157469|NCT01923181|BG006|Baseline|Oral Semaglutide 40 mg Fast Dose-escalation|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
11157470|NCT01923181|BG007|Baseline|Subcutaneous Semaglutide 1 mg|Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
11157471|NCT01923181|BG008|Baseline|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
11157472|NCT01923181|BG009|Baseline|Total|Total of all reporting groups
11174310|NCT02020863|BG000|Baseline|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
11157473|NCT01923181|FG000|Participant Flow|Oral Semaglutide 2.5 mg|Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157474|NCT01923181|FG001|Participant Flow|Oral Semaglutide 5 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157475|NCT01923181|FG002|Participant Flow|Oral Semaglutide 10 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157476|NCT01923181|FG003|Participant Flow|Oral Semaglutide 20 mg|"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.~Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets."
11157477|NCT01923181|FG004|Participant Flow|Oral Semaglutide 40 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157478|NCT01923181|FG005|Participant Flow|Oral Semaglutide 40 mg Slow Dose-escalation|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157479|NCT01923181|FG006|Participant Flow|Oral Semaglutide 40 mg Fast Dose-escalation|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
11157480|NCT01923181|FG007|Participant Flow|Subcutaneous Semaglutide 1 mg|Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
11157481|NCT01923181|FG008|Participant Flow|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
11157482|NCT01923181|OG000|Outcome|Oral Semaglutide 2.5 mg|Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157483|NCT01923181|OG001|Outcome|Oral Semaglutide 5 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157484|NCT01923181|OG002|Outcome|Oral Semaglutide 10 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157485|NCT01923181|OG003|Outcome|Oral Semaglutide 20 mg|"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.~Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets."
11157486|NCT01923181|OG004|Outcome|Oral Semaglutide 40 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157487|NCT01923181|OG005|Outcome|Oral Semaglutide 40 mg Slow Dose-escalation|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157488|NCT01923181|OG006|Outcome|Oral Semaglutide 40 mg Fast Dose-escalation|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
11157489|NCT01923181|OG007|Outcome|Oral Semaglutide 40 mg Pooled|The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
11157490|NCT01923181|OG008|Outcome|Subcutaneous Semaglutide 1 mg|Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
11174311|NCT02020863|FG000|Participant Flow|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
11157491|NCT01923181|OG009|Outcome|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
11157492|NCT01923181|OG007|Outcome|Subcutaneous Semaglutide 1 mg|Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
11157493|NCT01923181|OG008|Outcome|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
11157494|NCT01923181|EG000|Reported Event|Oral Semaglutide 2.5 mg|Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157495|NCT01923181|EG001|Reported Event|Oral Semaglutide 5 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157496|NCT01923181|EG002|Reported Event|Oral Semaglutide 10 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157497|NCT01923181|EG003|Reported Event|Oral Semaglutide 20 mg|"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.~Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets."
11157498|NCT01923181|EG004|Reported Event|Oral Semaglutide 40 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11174312|NCT02020863|OG000|Outcome|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
11233857|NCT02431364|BG001|Baseline|Verdinexor 5 mg|Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.
11233858|NCT02431364|BG002|Baseline|Verdinexor 10 mg|Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.
11157499|NCT01923181|EG005|Reported Event|Oral Semaglutide 40 mg Slow Dose-escalation|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
11157500|NCT01923181|EG006|Reported Event|Oral Semaglutide 40 mg Fast Dose-escalation|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
11157501|NCT01923181|EG007|Reported Event|Subcutaneous Semaglutide 1 mg|Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
11157502|NCT01923181|EG008|Reported Event|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
11157503|NCT01923285|BG000|Baseline|AXIUM Neurostimulator System|"The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.~AXIUM Neurostimulator System"
11157504|NCT01923285|BG001|Baseline|Control Spinal Cord Stimulation Device|"The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.~Control Spinal Cord Stimulation Device"
11157505|NCT01923285|BG002|Baseline|Total|Total of all reporting groups
11157506|NCT01923285|FG000|Participant Flow|AXIUM Neurostimulator System|"The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.~AXIUM Neurostimulator System"
11157507|NCT01923285|FG001|Participant Flow|Control Spinal Cord Stimulation Device|"The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.~Control Spinal Cord Stimulation Device"
11157508|NCT01923285|OG000|Outcome|AXIUM Neurostimulator System|"The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.~AXIUM Neurostimulator System"
11157509|NCT01923285|OG001|Outcome|Control Spinal Cord Stimulation Device|"The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.~Control Spinal Cord Stimulation Device"
11157510|NCT01923285|EG000|Reported Event|AXIUM Neurostimulator System|"The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.~AXIUM Neurostimulator System"
11157511|NCT01923285|EG001|Reported Event|Control Spinal Cord Stimulation Device|"The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.~Control Spinal Cord Stimulation Device"
11233859|NCT02431364|BG003|Baseline|Verdinexor 20 mg|Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.
11233860|NCT02431364|BG004|Baseline|Verdinexor 40 mg|Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
11233861|NCT02431364|BG005|Baseline|Total|Total of all reporting groups
10851412|NCT00306202|OG003|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
11089193|NCT01522417|FG000|Participant Flow|Short Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.~Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI."
11089194|NCT01522417|FG001|Participant Flow|Eptifibatide (Integrilin)|"Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.~Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first."
11089195|NCT01522417|FG002|Participant Flow|Long Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.~Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI."
11089196|NCT01522417|OG000|Outcome|Short Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.~Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI."
11089197|NCT01522417|OG001|Outcome|Eptifibatide (Integrilin)|"Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.~Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first."
11089198|NCT01522417|OG002|Outcome|Long Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.~Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI."
11089199|NCT01522417|EG000|Reported Event|Short Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.~Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI."
11089200|NCT01522417|EG001|Reported Event|Eptifibatide (Integrilin)|"Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.~Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first."
11089201|NCT01522417|EG002|Reported Event|Long Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.~Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).~Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI."
11089202|NCT01522443|BG000|Baseline|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
11089203|NCT01522443|BG001|Baseline|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
11089204|NCT01522443|BG002|Baseline|Total|Total of all reporting groups
11089205|NCT01522443|FG000|Participant Flow|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
11089206|NCT01522443|FG001|Participant Flow|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
11089207|NCT01522443|OG000|Outcome|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
11089208|NCT01522443|OG001|Outcome|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
11089209|NCT01522443|EG000|Reported Event|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
11157512|NCT01923311|BG000|Baseline|Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL|EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks with the option to continue receiving EVG after Week 48 in the extension phase, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
11157513|NCT01923311|BG001|Baseline|Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL|EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
11157514|NCT01923311|BG002|Baseline|Total|Total of all reporting groups
11157515|NCT01923311|FG000|Participant Flow|Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL|Elvitegravir (EVG) 50 mg, or 85 mg, or 150 mg tablet administered once daily (QD) for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following ritonavir (RTV) boosted-protease inhibitors (PI/r): lopinavir/r (Kaletra; LPV/r), atazanavir/r (ATV/r), darunavir/r (DRV/r), tipranavir/r (TPV/r), or fosamprenavir/r (FPV/r). Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
11157516|NCT01923311|FG001|Participant Flow|Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL|EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.).
11157517|NCT01923311|OG000|Outcome|Age 6 to < 12 Years|"PK results were summarized for all participants age 6 to < 12 years as one group.~EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg)."
11157518|NCT01923311|OG000|Outcome|Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL|EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
11157519|NCT01923311|OG001|Outcome|Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL|EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
11157520|NCT01923311|EG000|Reported Event|Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL|EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
11157521|NCT01923311|EG001|Reported Event|Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL|EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
11157522|NCT01923363|BG000|Baseline|Piperacillin/Tazobactam Standard to High Dose|Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
11157523|NCT01923363|FG000|Participant Flow|Piperacillin/Tazobactam Standard to High Dose|Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
11157524|NCT01923363|OG000|Outcome|Standard Dose to High Dose Piperacillin/Tazobactam|Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
11233862|NCT02431364|FG000|Participant Flow|Placebo|Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.
11157525|NCT01923363|EG000|Reported Event|Standard Dose to High Dose Piperacillin/Tazobactam|"Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.~Piperacillin/Tazobactam Standard Dose to High Dose: Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared."
11157526|NCT01923389|BG000|Baseline|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157527|NCT01923389|BG001|Baseline|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157528|NCT01923389|BG002|Baseline|Total|Total of all reporting groups
11157529|NCT01923389|FG000|Participant Flow|Placebo|Placebo (normal saline) was administered as a 20-milliliters (mL) intravenous (IV) infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157530|NCT01923389|FG001|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157531|NCT01923389|OG000|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157532|NCT01923389|OG001|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157533|NCT01923389|OG000|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157534|NCT01923389|EG000|Reported Event|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157535|NCT01923389|EG001|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
11157536|NCT01923428|BG000|Baseline|5 mg BID|AZD1722
11157537|NCT01923428|BG001|Baseline|20 mg BID|AZD1722
11157538|NCT01923428|BG002|Baseline|50 mg BID|AZD1722
11157539|NCT01923428|BG003|Baseline|Placebo|Placebo
10887750|NCT00502593|OG003|Outcome|Fluarix-B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887751|NCT00502593|OG004|Outcome|GSK1562902A-C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157540|NCT01923428|BG004|Baseline|Total|Total of all reporting groups
11157541|NCT01923428|FG000|Participant Flow|5 mg BID|AZD1722
11157542|NCT01923428|FG001|Participant Flow|20 mg BID|AZD1722
11157543|NCT01923428|FG002|Participant Flow|50 mg BID|AZD1722
11157544|NCT01923428|FG003|Participant Flow|Placebo|Placebo
11157545|NCT01923428|OG000|Outcome|5 mg BID|AZD1722
11157546|NCT01923428|OG001|Outcome|20 mg BID|AZD1722
11157547|NCT01923428|OG002|Outcome|50 mg BID|AZD1722
11157548|NCT01923428|OG003|Outcome|Placebo|Placebo
11157549|NCT01923428|EG000|Reported Event|5 mg BID|"AZD1722~AZD1722"
11157550|NCT01923428|EG001|Reported Event|20 mg BID|"AZD1722~AZD1722"
11157551|NCT01923428|EG002|Reported Event|50 mg BID|"AZD1722~AZD1722"
11157552|NCT01923428|EG003|Reported Event|Placebo|Placebo
11157553|NCT01923467|BG000|Baseline|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
11157554|NCT01923467|FG000|Participant Flow|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
11157555|NCT01923467|OG000|Outcome|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
11233863|NCT02431364|FG001|Participant Flow|Verdinexor 5 mg|Participants received verdinexor 5 milligrams (mg) (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.
11233864|NCT02431364|FG002|Participant Flow|Verdinexor 10 mg|Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.
11157556|NCT01923467|EG000|Reported Event|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
11157557|NCT01923740|BG000|Baseline|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
11157558|NCT01923740|BG001|Baseline|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
11157559|NCT01923740|BG002|Baseline|Total|Total of all reporting groups
11157560|NCT01923740|FG000|Participant Flow|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
11157561|NCT01923740|FG001|Participant Flow|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
11157562|NCT01923740|OG000|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
11157563|NCT01923740|OG001|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
11157564|NCT01923740|EG000|Reported Event|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
11157565|NCT01923740|EG001|Reported Event|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
11157566|NCT01923805|BG000|Baseline|Treatment Group|"Vitagel~Vitagel: Vitagel"
11157567|NCT01923805|BG001|Baseline|Control|Standard of care for surgical hemostasis.
11157568|NCT01923805|BG002|Baseline|Total|Total of all reporting groups
11157569|NCT01923805|FG000|Participant Flow|Treatment Group|"Vitagel~Vitagel: Vitagel"
11157570|NCT01923805|FG001|Participant Flow|Control|Standard of care for surgical hemostasis.
11157571|NCT01923805|OG000|Outcome|Treatment Group|"Vitagel~Vitagel: Vitagel"
11157572|NCT01923805|OG001|Outcome|Control|Standard of care for surgical hemostasis.
11157573|NCT01923805|EG000|Reported Event|Treatment Group|"Vitagel~Vitagel: Vitagel"
11157574|NCT01923805|EG001|Reported Event|Control|Standard of care for surgical hemostasis.
11157575|NCT01923896|BG000|Baseline|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
11157576|NCT01923896|BG001|Baseline|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
11157577|NCT01923896|BG002|Baseline|Total|Total of all reporting groups
11157578|NCT01923896|FG000|Participant Flow|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
11157579|NCT01923896|FG001|Participant Flow|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
11157580|NCT01923896|OG000|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
11157581|NCT01923896|OG001|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
11157582|NCT01923896|EG000|Reported Event|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
11157583|NCT01923896|EG001|Reported Event|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
11157584|NCT01923961|BG000|Baseline|HDF NaCl, Then HD, Then Standard Pre-HDF|Participants first received hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then received 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveived 4 hours of standard predilution hemodiafiltration.
11157585|NCT01923961|BG001|Baseline|HD, Then Standard Pre-HDF, Then HDF NaCl|Participants first received bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then received 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveived 4 hours of hemodiafiltration with infusion of 5 M NaCl.
11157586|NCT01923961|BG002|Baseline|Standard Pre-HDF, Then HDF NaCl, Then HD|Participants first received standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then received 4 hours of hemodiafiltration with infusion of 5 M NaCl. After another washout period of 1 week, they reveived 4 hours of bicarbonate hemodialysis.
11157587|NCT01923961|BG003|Baseline|Total|Total of all reporting groups
11157588|NCT01923961|FG000|Participant Flow|HDF NaCl Infusion, Then HD, Then Standard Pre-HDF|Participants first received hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then received 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveived 4 hours of standard predilution hemodiafiltration.
11157589|NCT01923961|FG001|Participant Flow|HD, Then Standard Pre-HDF, Then HDF NaCl Infusion|Participants first received bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then received 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveived 4 hours of hemodiafiltration with infusion of 5 M NaCl.
11157590|NCT01923961|FG002|Participant Flow|Standard Pre-HDF, Then HDF NaCl Infusion, Then HD|Participants first received standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then received 4 hours of hemodiafiltration with infusion of 5 M NaCl. After another washout period of 1 week, they reveived 4 hours of bicarbonate hemodialysis.
11157591|NCT01923961|OG000|Outcome|Hemodiafiltration, NaCl Infusion|"5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.~5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma."
11157592|NCT01923961|OG001|Outcome|Hemodialysis|Standard bicarbonate high-flux hemodialysis
11157593|NCT01923961|OG002|Outcome|Hemodiafiltration|Standard predilution Hemodiafiltration
11157594|NCT01923961|EG000|Reported Event|Hemodiafiltration, NaCl Infusion|"5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.~5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma."
11157595|NCT01923961|EG001|Reported Event|Hemodialysis|Standard bicarbonate high-flux hemodialysis
11157596|NCT01923961|EG002|Reported Event|Hemodiafiltration|Standard predilution Hemodiafiltration
11157597|NCT01924169|BG000|Baseline|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
11157598|NCT01924169|FG000|Participant Flow|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If Immunoglobulin G (IgG) levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
11157599|NCT01924169|OG000|Outcome|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
11157600|NCT01924169|EG000|Reported Event|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
11157601|NCT01924182|BG000|Baseline|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
11157602|NCT01924182|BG001|Baseline|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
11157603|NCT01924182|BG002|Baseline|Total|Total of all reporting groups
11157604|NCT01924182|FG000|Participant Flow|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
11157605|NCT01924182|FG001|Participant Flow|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
11157606|NCT01924182|OG000|Outcome|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
11157607|NCT01924182|OG001|Outcome|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
11233865|NCT02431364|FG003|Participant Flow|Verdinexor 20 mg|Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.
11157608|NCT01924182|EG000|Reported Event|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
11157609|NCT01924182|EG001|Reported Event|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
11157610|NCT01924299|BG000|Baseline|Baricitinib + Ketoconazole (Group A)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.~400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2."
11157611|NCT01924299|BG001|Baseline|Baricitinib + Fluconazole (Group B)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.~400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2."
11157612|NCT01924299|BG002|Baseline|Total|Total of all reporting groups
11157613|NCT01924299|FG000|Participant Flow|Baricitinib + Ketoconazole (Group A)|"10 milligrams (mg) baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.~400 mg ketoconazole administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2."
11157614|NCT01924299|FG001|Participant Flow|Baricitinib + Fluconazole (Group B)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.~400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2."
11157615|NCT01924299|OG000|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
11157616|NCT01924299|OG001|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
10887752|NCT00502593|OG005|Outcome|Fluarix-C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157617|NCT01924299|OG000|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
11157618|NCT01924299|OG001|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
11157619|NCT01924299|EG000|Reported Event|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
11157620|NCT01924299|EG001|Reported Event|Ketoconazole (Group A)|400 mg ketoconazole administered orally QD on Day 3 through Day 5 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 6.
11157621|NCT01924299|EG002|Reported Event|Baricitinib + Ketoconazole (Group A)|"10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg ketoconazole administered orally QD on Day 6 through Day 8 in Period 2.~Adverse events are reported from postdose on Day 6 up to Day 22."
11157622|NCT01924299|EG003|Reported Event|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
11157623|NCT01924299|EG004|Reported Event|Fluconazole (Group B)|"400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD on Day 4 through Day 6 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 7."
11157624|NCT01924299|EG005|Reported Event|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 200 mg fluconazole administered orally QD on Day 7 through Day 9 in Period 2. Adverse events are reported from postdose on Day 7 up to Day 23.
11157625|NCT01924364|BG000|Baseline|Fat Grafting|Tissue Genesis Cell Isolation System™ (CIS): In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101) will be used for comparison.
11157626|NCT01924364|FG000|Participant Flow|Fat Grafting|Same patient received either fat graft treatment supplemented with TGI or no TGI, randomized per site.
11157627|NCT01924364|OG000|Outcome|TGI_Fat Volume Injected|
11157628|NCT01924364|OG001|Outcome|TGI_Facial Volume at 3 Month PO|Facial volume at 3 month post-operative
11157629|NCT01924364|OG002|Outcome|TGI_Facial Volume at 9 Month PO|Facial volume at 9 month PO
11157630|NCT01924364|OG003|Outcome|TGI_Facial Volume at 12 Month PO|Facial volume at 12 month post-operative
11157631|NCT01924364|OG004|Outcome|TGI_Facial Volume at 24 Month PO|Facial volume at 24 month PO
11157632|NCT01924364|OG005|Outcome|Standard_Fat Volume Injected|
11157633|NCT01924364|OG006|Outcome|Standard_Facial Volume at 3 Month PO|Standard_Facial volume at 3 month PO
11157634|NCT01924364|OG007|Outcome|Standard_Facial Volume at 9 Month PO|Facial volume at 9 month PO
11157635|NCT01924364|OG008|Outcome|Standard_Facial Volume at 12 Month PO|Standard_Facial volume at 12 month PO
11157636|NCT01924364|OG009|Outcome|Standard_Facial Volume at 24 Month PO|Standard_Facial volume at 24 month PO
11157637|NCT01924364|OG000|Outcome|TGI_Stem Cell Viability Yield|%age of cells yield/volume of fat tissue
11157638|NCT01924364|OG001|Outcome|Standard_Stem Cell Viability Yield|%age of cells yield/volume of fat tissue
11157639|NCT01924364|EG000|Reported Event|Fat Grafting|Tissue Genesis Cell Isolation System™ (TGI CIS): In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (TGI CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient.
11157640|NCT01924390|BG000|Baseline|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
11157641|NCT01924390|BG001|Baseline|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
11157642|NCT01924390|BG002|Baseline|Total|Total of all reporting groups
11157643|NCT01924390|FG000|Participant Flow|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
11157644|NCT01924390|FG001|Participant Flow|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
11157645|NCT01924390|OG000|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
11157646|NCT01924390|OG001|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
11157647|NCT01924390|EG000|Reported Event|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
10887753|NCT00502593|OG000|Outcome|GSK1562902A-B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157648|NCT01924390|EG001|Reported Event|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
11157649|NCT01924429|BG000|Baseline|On Drug, Then Off Drug|fMRI #1 on drug, #2 off drug
11157650|NCT01924429|BG001|Baseline|Off Drug, Then on Drug|fMRI #1 off drug, #2 on drug
11157651|NCT01924429|BG002|Baseline|Total|Total of all reporting groups
11157652|NCT01924429|FG000|Participant Flow|On Drug Then Off Drug|"Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg~Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg"
11157653|NCT01924429|FG001|Participant Flow|Off Drug Then on Drug|"Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg~Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg"
11157654|NCT01924429|OG000|Outcome|Placebo|Participants received fMRI while off drug
11157655|NCT01924429|OG001|Outcome|Lisdexamfetamine|Participants received fMRI while on drug
11157656|NCT01924429|OG000|Outcome|On Drug Then Off Drug|"Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg~Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg"
11157657|NCT01924429|OG001|Outcome|Off Drug Then on Drug|"Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg~Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg"
11157658|NCT01924429|EG000|Reported Event|On Drug, Then Off Drug|"Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg~Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg"
11157659|NCT01924429|EG001|Reported Event|Off Drug, Then on Drug|"Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg~Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg"
11157660|NCT01924442|BG000|Baseline|On-Pump|Cardiac bypass using Heart Lung Machine
11157661|NCT01924442|BG001|Baseline|Off-Pump|Cardiac bypass surgery on beating heart
11157662|NCT01924442|BG002|Baseline|Total|Total of all reporting groups
11157663|NCT01924442|FG000|Participant Flow|On-Pump|Cardiac bypass using Heart Lung Machine
11157664|NCT01924442|FG001|Participant Flow|Off-Pump|Cardiac bypass surgery on beating heart
11157665|NCT01924442|OG000|Outcome|On-Pump|Cardiac bypass using Heart Lung Machine
11157666|NCT01924442|OG001|Outcome|Off-Pump|Cardiac bypass surgery on beating heart
11157667|NCT01924442|EG000|Reported Event|On-Pump|Cardiac bypass using Heart Lung Machine
11157668|NCT01924442|EG001|Reported Event|Off-Pump|Cardiac bypass surgery on beating heart
11157669|NCT01924559|BG000|Baseline|SALT and Biohazard Gear|All participants were tested on three intubation devices in either standard clothing or biohazard gear.
11157670|NCT01924559|FG000|Participant Flow|All Study Participants|All participants were randomized into groups testing three intubation devices while wearing standard clothing or biohazard gear..
11157671|NCT01924559|OG000|Outcome|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.~standard clothing~DL"
11157672|NCT01924559|OG001|Outcome|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.~Biohazard gear~DL"
11157673|NCT01924559|OG002|Outcome|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.~standard clothing~Glidescope"
11157674|NCT01924559|OG003|Outcome|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.~Biohazard gear~Glidescope"
11157675|NCT01924559|OG004|Outcome|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.~standard clothing~SALT"
11157676|NCT01924559|OG005|Outcome|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.~Biohazard gear~SALT"
11157677|NCT01924559|EG000|Reported Event|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.~standard clothing~DL"
11157678|NCT01924559|EG001|Reported Event|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.~Biohazard gear~DL"
11157679|NCT01924559|EG002|Reported Event|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.~standard clothing~GlideScope"
11157680|NCT01924559|EG003|Reported Event|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.~Biohazard gear~GlideScope"
11157681|NCT01924559|EG004|Reported Event|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.~standard clothing~SALT"
11157682|NCT01924559|EG005|Reported Event|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.~Biohazard gear~SALT No adverse events"
11157683|NCT01924689|BG000|Baseline|Cohort 1|Cohort 1: 1 x 10^4 spores
11157684|NCT01924689|BG001|Baseline|Cohort 2|Cohort 2: 3 x 10^4 spores
11157685|NCT01924689|BG002|Baseline|Cohort 3|Cohort 3: 10 x 10^4 spores
11157686|NCT01924689|BG003|Baseline|Cohort 4|Cohort 4: 30 x 10^4 spores
11157687|NCT01924689|BG004|Baseline|Cohort 5|Cohort 5: 100 x 10^4 spores
11157688|NCT01924689|BG005|Baseline|Cohort 6|Cohort 6: 300 x 10^4 spores
11157689|NCT01924689|BG006|Baseline|Total|Total of all reporting groups
11157690|NCT01924689|FG000|Participant Flow|Cohort 1|Patients received only single dose of C. novyi-NT spores (Cohort 1: 1 x 10^4 spores) as an intratumoral (IT) injection, per protocol (pp).
11157691|NCT01924689|FG001|Participant Flow|Cohort 2|Patients received only single dose of C. novyi-NT spores (Cohort 2: 3 x 10^4 spores) as an IT injection, pp.
11157692|NCT01924689|FG002|Participant Flow|Cohort 3|Patients received only single dose of C. novyi-NT spores (Cohort 3: 10 x 10^4 spores) as an IT injection, pp.
11157693|NCT01924689|FG003|Participant Flow|Cohort 4|Patients received only single dose of C. novyi-NT spores (Cohort 4: 30 x 10^4 spores) as an IT injection, pp.
11157694|NCT01924689|FG004|Participant Flow|Cohort 5|Patients received only single dose of C. novyi-NT spores (Cohort 5: 100 x 10^4 spores) as an IT injection, pp.
11157695|NCT01924689|FG005|Participant Flow|Cohort 6|Patients received only single dose of C. novyi-NT spores (Cohort 6: 300 x 10^4 spores) as an IT injection, pp.
11157696|NCT01924689|OG000|Outcome|Cohort 1|Cohort 1: 1 x 10^4 spores
11157697|NCT01924689|OG001|Outcome|Cohort 2|Cohort 2: 3 x 10^4 spores
11157698|NCT01924689|OG002|Outcome|Cohort 3|Cohort 3: 10 x 10^4 spores
11157699|NCT01924689|OG003|Outcome|Cohort 4|Cohort 4: 30 x 10^4 spores
11157700|NCT01924689|OG004|Outcome|Cohort 5|Cohort 5: 100 x 10^4 spores
11157701|NCT01924689|OG005|Outcome|Cohort 6|Cohort 6: 300 x 10^4 spores
11157702|NCT01924689|OG000|Outcome|Cohort 3|Cohort 3: 10 x 10^4 spores
11157703|NCT01924689|OG001|Outcome|Cohort 4|Cohort 4: 30 x 10^4 spores
11157704|NCT01924689|OG002|Outcome|Cohort 5|Cohort 5: 100 x 10^4 spores
11157705|NCT01924689|OG003|Outcome|Cohort 6|Cohort 6: 300 x 10^4 spores
11157706|NCT01924689|EG000|Reported Event|Cohort 1|Cohort 1: 1 x 10^4 spores
11157707|NCT01924689|EG001|Reported Event|Cohort 2|Cohort 2: 3 x 10^4 spores
11157708|NCT01924689|EG002|Reported Event|Cohort 3|Cohort 3: 10 x 10^4 spores
11157709|NCT01924689|EG003|Reported Event|Cohort 4|Cohort 4: 30 x 10^4 spores
11157710|NCT01924689|EG004|Reported Event|Cohort 5|Cohort 5: 100 x 10^4 spores
11157711|NCT01924689|EG005|Reported Event|Cohort 6|Cohort 6: 300 x 10^4 spores
11157712|NCT01924754|BG000|Baseline|Standard Intramuscular Injection (NS-IM)|HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
11157713|NCT01924754|BG001|Baseline|PharmaJet Needle-free Stratis Device (JI-IM)|HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
11157714|NCT01924754|BG002|Baseline|PharmaJet Needle-free Tropis Device (JI-ID)|HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
11157715|NCT01924754|BG003|Baseline|Total|Total of all reporting groups
11157716|NCT01924754|FG000|Participant Flow|Standard Intramuscular Injection (NS-IM)|Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
11157717|NCT01924754|FG001|Participant Flow|PharmaJet Needle-free Stratis Device (JI-IM)|HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
11157718|NCT01924754|FG002|Participant Flow|PharmaJet Needle-free Tropis Device (JI-ID)|HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
11157719|NCT01924754|OG000|Outcome|Standard Intramuscular Injection (NS-IM)|Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
11157720|NCT01924754|OG001|Outcome|PharmaJet Needle-free Stratis Device (JI-IM)|HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
11157721|NCT01924754|OG002|Outcome|PharmaJet Needle-free Tropis Device (JI-ID)|HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
11157722|NCT01924754|OG000|Outcome|Standard Intramuscular Injection (NS-IM)|HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
11157723|NCT01924754|OG000|Outcome|PharmaJet Needle-free Stratis Device (JI-IM)|HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
11157724|NCT01924754|OG001|Outcome|PharmaJet Needle-free Tropis Device (JI-ID)|HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
11157725|NCT01924754|EG000|Reported Event|Standard Intramuscular Injection (NS-IM)|HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
11157726|NCT01924754|EG001|Reported Event|PharmaJet Needle-free Stratis Device (JI-IM)|HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
11233866|NCT02431364|FG004|Participant Flow|Verdinexor 40 mg|Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
11157727|NCT01924754|EG002|Reported Event|PharmaJet Needle-free Tropis Device (JI-ID)|HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
11157728|NCT01924767|BG000|Baseline|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
11157729|NCT01924767|BG001|Baseline|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
11157730|NCT01924767|BG002|Baseline|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
11157731|NCT01924767|BG003|Baseline|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
11157732|NCT01924767|BG004|Baseline|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
11157733|NCT01924767|BG005|Baseline|Total|Total of all reporting groups
11157734|NCT01924767|FG000|Participant Flow|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
11157735|NCT01924767|FG001|Participant Flow|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
11157736|NCT01924767|FG002|Participant Flow|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
11157737|NCT01924767|FG003|Participant Flow|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
11157738|NCT01924767|FG004|Participant Flow|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
11157739|NCT01924767|OG000|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
11157740|NCT01924767|OG001|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
11157741|NCT01924767|OG002|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
11157742|NCT01924767|OG003|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
11157743|NCT01924767|OG004|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
11157744|NCT01924767|OG000|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
11157745|NCT01924767|OG001|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
11157746|NCT01924767|OG002|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
11157747|NCT01924767|OG003|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
11157748|NCT01924767|OG000|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
11157749|NCT01924767|EG000|Reported Event|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
11157750|NCT01924767|EG001|Reported Event|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
11157751|NCT01924767|EG002|Reported Event|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
11157752|NCT01924767|EG003|Reported Event|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
11157753|NCT01924767|EG004|Reported Event|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
11157754|NCT01924806|BG000|Baseline|WoundWand™ Debridement Device|WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device.
11157755|NCT01924806|BG001|Baseline|Standard of Care Sharp Debridement|Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia.
11157756|NCT01924806|BG002|Baseline|Total|Total of all reporting groups
11157757|NCT01924806|FG000|Participant Flow|WoundWand™ Debridement Device|WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device.
11157758|NCT01924806|FG001|Participant Flow|Standard of Care Sharp Debridement|Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia.
11157759|NCT01924806|OG000|Outcome|WoundWand™ Debridement Device|WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device.
11157760|NCT01924806|OG001|Outcome|Standard of Care Sharp Debridement|Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia.
11233867|NCT02431364|OG000|Outcome|Placebo|Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.
11157761|NCT01924806|EG000|Reported Event|WoundWand™ Debridement Device|"Group I - Coblator IQTM Controller plus WoundWand™ Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound.~WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound"
11157762|NCT01924806|EG001|Reported Event|Standard of Care Sharp Debridement|"Group II - Standard of Care (SoC) surgical (sharp) debridement. Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound.~Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound"
11157763|NCT01924845|BG000|Baseline|BMN 701 20 mg/kg|BMN 701 20 mg/kg
11157764|NCT01924845|FG000|Participant Flow|BMN 701 20 mg/kg|BMN 701 20 mg/kg
11157765|NCT01924845|OG000|Outcome|BMN701 20 mg/kg|BMN701 20 mg/kg
11157766|NCT01924845|EG000|Reported Event|BMN 701 20 mg/kg|BMN 701 20 mg/kg
11157767|NCT01924871|BG000|Baseline|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
11157768|NCT01924871|BG001|Baseline|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
11157769|NCT01924871|BG002|Baseline|Total|Total of all reporting groups
11157770|NCT01924871|FG000|Participant Flow|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
11157771|NCT01924871|FG001|Participant Flow|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
11157772|NCT01924871|OG000|Outcome|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
11157773|NCT01924871|OG001|Outcome|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
11157774|NCT01924871|EG000|Reported Event|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
11157775|NCT01924871|EG001|Reported Event|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
11157776|NCT01924949|BG000|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
11157777|NCT01924949|FG000|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
11157778|NCT01924949|OG000|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
11157779|NCT01924949|EG000|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
11157780|NCT01924975|BG000|Baseline|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
11157781|NCT01924975|BG001|Baseline|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
11157782|NCT01924975|BG002|Baseline|Total|Total of all reporting groups
11157783|NCT01924975|FG000|Participant Flow|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
11157784|NCT01924975|FG001|Participant Flow|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
11157785|NCT01924975|OG000|Outcome|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
11157786|NCT01924975|OG001|Outcome|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
11157787|NCT01924975|EG000|Reported Event|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
11157788|NCT01924975|EG001|Reported Event|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
11157789|NCT01924988|BG000|Baseline|Safety of Prostate Artery Embolization|This is a study focused on the safety of prostate artery embolization based primarily on cystoscopic evaluation after embolization.
11157790|NCT01924988|FG000|Participant Flow|Prostatic Embolization|"This single-center, Phase I prospective, observational, non-comparative study of the safety and effectiveness of prostate artery embolization for symptomatic benign prostatic hyperplasia. The primary outcome was to determine the frequency of adverse events, focusing on procedure-related bladder and rectal complications as detected by cystoscopic and anoscopic assessment post-treatment. The secondary objectives were to measure the effectiveness in diminishing symptoms of lower urinary tract symptom (LUTS) from treatment.~The inclusion criteria were as follows: Men presenting with benign prostatic hyperplasia with symptoms for at least 6 months. Additional criteria included moderate to severe obstructive urinary tract symptoms as defined as an International Prostate Symptom Score (IPSS) score of 12 or greater, and peak urinary flow (QMax) of less than 12 mL/s or acute urinary retention."
11157791|NCT01924988|OG000|Outcome|Prostate Artery Embolization|Therapeutic embolization of the prostate arteries to treat benign prostatic hyperplasia.
11157792|NCT01924988|OG000|Outcome|Prostate Artery Embolization|Therapeutic embolization of the prostate for treatment of benign prostate hyperplasia
11157793|NCT01924988|OG000|Outcome|Number With Bladder Injury at 3 Months|Those with bladder injury detected by cystoscopy
11157794|NCT01924988|OG000|Outcome|Cystoscopy Outcomes 12 Months|Number of patients with a bladder injury 12 months after treatment.
11157795|NCT01924988|EG000|Reported Event|Adverse Events|Summary of adverse events
11157796|NCT01925014|BG000|Baseline|Low-dose CT|2 millisievert
11157797|NCT01925014|BG001|Baseline|Standard-dose CT|8 millisievert or lower
11157798|NCT01925014|BG002|Baseline|Total|Total of all reporting groups
11157799|NCT01925014|FG000|Participant Flow|Low-dose CT|2 millisievert
11157800|NCT01925014|FG001|Participant Flow|Standard-dose CT|8 millisievert or lower
11157801|NCT01925014|OG000|Outcome|Low-dose CT|2 millisievert
11157802|NCT01925014|OG001|Outcome|Standard-dose CT|8 millisievert or lower
11157803|NCT01925014|EG000|Reported Event|Low-dose CT|2 millisievert
11157804|NCT01925014|EG001|Reported Event|Standard-dose CT|8 millisievert or lower
11157805|NCT01925144|BG000|Baseline|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
11157806|NCT01925144|FG000|Participant Flow|Baricitinib + Omeprazole|"10 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, once daily (QD), for 8 days (Days 3 through 10) in Period 2."
11157807|NCT01925144|OG000|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
11157808|NCT01925144|OG001|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
11157809|NCT01925144|EG000|Reported Event|Baricitinib|"10 mg baricitinib tablet administered orally once, on Day 1 in Period 1.~Adverse events are reported from baseline through predose on Day 3."
11157810|NCT01925144|EG001|Reported Event|Omeprazole|"40 mg omeprazole capsule administered orally, QD, on Days 3 through 9 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 10."
11157811|NCT01925144|EG002|Reported Event|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally once with 40 mg omeprazole capsule orally once, on Day 10 in Period 2.~Adverse events are reported from postdose on Day 10 up to Day 24."
11157812|NCT01925170|BG000|Baseline|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.~Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.~Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.~Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
11157813|NCT01925170|FG000|Participant Flow|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.~Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.~Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.~Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
11157814|NCT01925170|OG000|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
11157815|NCT01925170|OG001|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
11157816|NCT01925170|OG002|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
11233868|NCT02431364|OG001|Outcome|Verdinexor 5 mg|Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.
11157817|NCT01925170|EG000|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
11157818|NCT01925183|BG000|Baseline|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
11157819|NCT01925183|BG001|Baseline|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
11157820|NCT01925183|BG002|Baseline|Total|Total of all reporting groups
11157821|NCT01925183|FG000|Participant Flow|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of pegylated interferon/ribavirin (PEGIFN/RBV) lead-in. Patients with undetectable hepatitis C virus (HCV)-RNA at treatment week 8 will be treated with 24 weeks of boceprevir (BOC)/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
11157822|NCT01925183|FG001|Participant Flow|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
11157823|NCT01925183|OG000|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
11157824|NCT01925183|OG001|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
11157825|NCT01925183|EG000|Reported Event|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
11157826|NCT01925183|EG001|Reported Event|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
11157827|NCT01925209|BG000|Baseline|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
11157828|NCT01925209|BG001|Baseline|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157829|NCT01925209|BG002|Baseline|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157830|NCT01925209|BG003|Baseline|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157831|NCT01925209|BG004|Baseline|Total|Total of all reporting groups
11157832|NCT01925209|FG000|Participant Flow|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
11157833|NCT01925209|FG001|Participant Flow|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157834|NCT01925209|FG002|Participant Flow|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157835|NCT01925209|FG003|Participant Flow|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11233869|NCT02431364|OG002|Outcome|Verdinexor 10 mg|Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.
11157836|NCT01925209|OG000|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
11157837|NCT01925209|OG001|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157838|NCT01925209|OG002|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157839|NCT01925209|OG003|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157840|NCT01925209|EG000|Reported Event|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
11157841|NCT01925209|EG001|Reported Event|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157842|NCT01925209|EG002|Reported Event|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157843|NCT01925209|EG003|Reported Event|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
11157844|NCT01925274|BG000|Baseline|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157845|NCT01925274|BG001|Baseline|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
11157846|NCT01925274|BG002|Baseline|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157847|NCT01925274|BG003|Baseline|Total|Total of all reporting groups
11157848|NCT01925274|FG000|Participant Flow|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157849|NCT01925274|FG001|Participant Flow|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
11157850|NCT01925274|FG002|Participant Flow|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157851|NCT01925274|OG000|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157852|NCT01925274|OG001|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
11233870|NCT02431364|OG003|Outcome|Verdinexor 20 mg|Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.
11233871|NCT02431364|OG004|Outcome|Verdinexor 40 mg|Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
11157853|NCT01925274|OG000|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157854|NCT01925274|OG002|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157855|NCT01925274|OG001|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157856|NCT01925274|EG000|Reported Event|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157857|NCT01925274|EG001|Reported Event|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
11157858|NCT01925274|EG002|Reported Event|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28 day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF 05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
11157859|NCT01925339|BG000|Baseline|Test (Immediate Restoration)|"Test (immediate restoration): immediate restoration will be placed on immediately placed implants.~Test (immediate restoration): Test (immediate restoration)"
11157860|NCT01925339|BG001|Baseline|Control: Delayed Restoration|"Control: delayed restoration: immediate placed implants will be restored at 4 months.~Control: delayed restoration: Control: delayed restoration"
11157861|NCT01925339|BG002|Baseline|Total|Total of all reporting groups
11157862|NCT01925339|FG000|Participant Flow|Test (Immediate Restoration)|"Test (immediate restoration): immediate restoration will be placed on immediately placed implants.~Test (immediate restoration): Test (immediate restoration)"
11157863|NCT01925339|FG001|Participant Flow|Control: Delayed Restoration|"Control: delayed restoration: immediate placed implants will be restored at 4 months.~Control: delayed restoration: Control: delayed restoration"
11157864|NCT01925339|OG000|Outcome|Test (Immediate Restoration)|"Test (immediate restoration): immediate restoration will be placed on immediately placed implants.~Test (immediate restoration): Test (immediate restoration)"
11157865|NCT01925339|OG001|Outcome|Control: Delayed Restoration|"Control: delayed restoration: immediate placed implants will be restored at 4 months.~Control: delayed restoration: Control: delayed restoration"
11157866|NCT01925339|EG000|Reported Event|Test (Immediate Restoration)|"Test (immediate restoration): immediate restoration will be placed on immediately placed implants.~Test (immediate restoration): Test (immediate restoration)"
11157867|NCT01925339|EG001|Reported Event|Control: Delayed Restoration|"Control: delayed restoration: immediate placed implants will be restored at 4 months.~Control: delayed restoration: Control: delayed restoration"
11157868|NCT01925404|BG000|Baseline|Frequent User Arm|"Park users will be able to earn rewards or prizes by coming more frequently to the park~Frequent User: Participants can become eligible for prizes by visiting the park more frequently"
11157869|NCT01925404|BG001|Baseline|Free Physical Activity Classes/Programs|"We will offer at least 100 free physical activity classes at the park~Free physical activity classes: 100 hours of free activity classes will be provided"
11157870|NCT01925404|BG002|Baseline|Combined Arm|"We will offer free classes and the frequent user program at the park~Free physical activity classes: 100 hours of free activity classes will be provided~Frequent User: Participants can become eligible for prizes by visiting the park more frequently"
11157871|NCT01925404|BG003|Baseline|Control|Business as usual, no special physical activity programs offered
11157872|NCT01925404|BG004|Baseline|Total|Total of all reporting groups
11157873|NCT01925404|FG000|Participant Flow|Frequent User Arm|"Park users will be able to earn rewards or prizes by coming more frequently to the park~Frequent User: Participants can become eligible for prizes by visiting the park more frequently"
11157874|NCT01925404|FG001|Participant Flow|Free Physical Activity Classes/Programs|"We will offer at least 100 free physical activity classes at the park~Free physical activity classes: 100 hours of free activity classes will be provided"
11157875|NCT01925404|FG002|Participant Flow|Combined Arm|"We will offer free classes and the frequent user program at the park~Free physical activity classes: 100 hours of free activity classes will be provided~Frequent User: Participants can become eligible for prizes by visiting the park more frequently"
11157876|NCT01925404|FG003|Participant Flow|Control|Business as usual, no special physical activity programs offered
11157877|NCT01925404|OG000|Outcome|Frequent User Arm|"Park users will be able to earn rewards or prizes by coming more frequently to the park~Frequent User: Participants can become eligible for prizes by visiting the park more frequently"
11157878|NCT01925404|OG001|Outcome|Free Physical Activity Classes/Programs|"We will offer at least 100 free physical activity classes at the park~Free physical activity classes: 100 hours of free activity classes will be provided"
11157879|NCT01925404|OG002|Outcome|Combined Arm|"We will offer free classes and the frequent user program at the park~Free physical activity classes: 100 hours of free activity classes will be provided~Frequent User: Participants can become eligible for prizes by visiting the park more frequently"
11157880|NCT01925404|OG003|Outcome|Control|Business as usual, no special physical activity programs offered
11157881|NCT01925404|EG000|Reported Event|Frequent User Arm|"Park users will be able to earn rewards or prizes by coming more frequently to the park~Frequent User: Participants can become eligible for prizes by visiting the park more frequently"
11157882|NCT01925404|EG001|Reported Event|Free Physical Activity Classes/Programs|"We will offer at least 100 free physical activity classes at the park~Free physical activity classes: 100 hours of free activity classes will be provided"
11157883|NCT01925404|EG002|Reported Event|Combined Arm|"We will offer free classes and the frequent user program at the park~Free physical activity classes: 100 hours of free activity classes will be provided~Frequent User: Participants can become eligible for prizes by visiting the park more frequently"
11157884|NCT01925404|EG003|Reported Event|Control|Business as usual, no special physical activity programs offered
11157885|NCT01925417|BG000|Baseline|RBX2660 (Microbiota Suspension)|Open-label; all subjects received RBX2660
11157886|NCT01925417|FG000|Participant Flow|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
11157887|NCT01925417|OG000|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
11157888|NCT01925417|OG000|Outcome|RBX2660 (Microbiota Suspension)|RBX2660 (microbiota suspension) enema-based delivery
11157889|NCT01925417|EG000|Reported Event|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
11157890|NCT01925469|BG000|Baseline|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
11157891|NCT01925469|BG001|Baseline|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
11157892|NCT01925469|BG002|Baseline|Total|Total of all reporting groups
11157893|NCT01925469|FG000|Participant Flow|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
11157894|NCT01925469|FG001|Participant Flow|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
11157895|NCT01925469|OG000|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
11157896|NCT01925469|OG001|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
11157897|NCT01925469|EG000|Reported Event|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
11157898|NCT01925469|EG001|Reported Event|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
11157899|NCT01925612|BG000|Baseline|Part 1: BV(1.2 mg/kg) + RCHOP|"Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157900|NCT01925612|BG001|Baseline|Part 1: BV(1.8 mg/kg) + RCHOP|"Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157901|NCT01925612|BG002|Baseline|Part 2: BV(1.8 mg/kg) + RCHP|"Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157902|NCT01925612|BG003|Baseline|Part 3: BV(1.8 mg/kg) + RCHP|"Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157903|NCT01925612|BG004|Baseline|Part 3: RCHOP|"Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157904|NCT01925612|BG005|Baseline|Total|Total of all reporting groups
11157905|NCT01925612|FG000|Participant Flow|Part 1: BV(1.2 mg/kg) + RCHOP|"Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).~brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157906|NCT01925612|FG001|Participant Flow|Part 1: BV(1.8 mg/kg) + RCHOP|"Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157907|NCT01925612|FG002|Participant Flow|Part 2: BV(1.8 mg/kg) + RCHP|"Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157908|NCT01925612|FG003|Participant Flow|Part 3: BV(1.8 mg/kg) + RCHP|"Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157909|NCT01925612|FG004|Participant Flow|Part 3: RCHOP|"Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157910|NCT01925612|OG000|Outcome|Part 1: BV(1.2 mg/kg) + RCHOP|"Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).~brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157911|NCT01925612|OG001|Outcome|Part 1: BV(1.8 mg/kg) + RCHOP|"Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157912|NCT01925612|OG002|Outcome|Part 2: BV(1.8 mg/kg) + RCHP|"Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157913|NCT01925612|OG003|Outcome|Part 3: BV(1.8 mg/kg) + RCHP|"Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157914|NCT01925612|OG004|Outcome|Part 3: RCHOP|"Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11233872|NCT02431364|OG000|Outcome|Verdinexor 5 mg|Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.
10887754|NCT00502593|OG001|Outcome|Fluarix-B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887755|NCT00502593|OG000|Outcome|GSK1562902A-C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11157915|NCT01925612|EG000|Reported Event|Part 1: BV(1.2 mg/kg) + RCHOP|"Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157916|NCT01925612|EG001|Reported Event|Part 1: BV(1.8 mg/kg) + RCHOP|"Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157917|NCT01925612|EG002|Reported Event|Part 2: BV(1.8 mg/kg) + RCHP|"Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157918|NCT01925612|EG003|Reported Event|Part 3: BV(1.8 mg/kg) + RCHP|"Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone~brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157919|NCT01925612|EG004|Reported Event|Part 3: RCHOP|"Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles"
11157920|NCT01925677|BG000|Baseline|da Vinci® Single-Site™|"Robotic-assisted single-incision laparoscopic nephrectomy.~da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System."
11157921|NCT01925677|FG000|Participant Flow|da Vinci® Single-Site™|"Robotic-assisted single-incision laparoscopic nephrectomy.~da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System."
11157922|NCT01925677|OG000|Outcome|da Vinci® Single-Site™|"Robotic-assisted single-incision laparoscopic nephrectomy.~da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System."
11157923|NCT01925677|EG000|Reported Event|da Vinci® Single-Site™|"Robotic-assisted single-incision laparoscopic nephrectomy.~da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System."
11157924|NCT01925703|BG000|Baseline|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
11157925|NCT01925703|FG000|Participant Flow|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
11157926|NCT01925703|OG000|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
11157927|NCT01925703|EG000|Reported Event|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
11157928|NCT01925768|BG000|Baseline|Placebo (PBO)|Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.
11157929|NCT01925768|BG001|Baseline|Apremilast (APR) 30 mg|Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.
11157930|NCT01925768|BG002|Baseline|Total|Total of all reporting groups
11157931|NCT01925768|FG000|Participant Flow|Placebo/Apremilast (PBO)|Participants were randomized to placebo tablets twice daily (BID) during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator and transitioned onto apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind, 24-week treatment phase entered into the blinded, active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. Participants who completed the active treatment phase entered into the open-label extension phase for an additional year (Week 52 to Week 104) continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.
11233873|NCT02431364|OG001|Outcome|Verdinexor 10 mg|Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.
11157932|NCT01925768|FG001|Participant Flow|Apremilast (APR)|Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.
11157933|NCT01925768|OG000|Outcome|Placebo (PBO)|Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.
11157934|NCT01925768|OG001|Outcome|Apremilast (APR) 30 mg|Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.
11157935|NCT01925768|OG001|Outcome|Apremilast (APR)|Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.
11157936|NCT01925768|OG000|Outcome|Placebo/Apremilast (PBO-APR)|Participants initially randomized to placebo tablets BID in the 24-week place controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who required EE were transitioned to apremilast 30 mg BID in a blinded fashion and remained on their original treatment assignment.
11157937|NCT01925768|OG000|Outcome|Apremilast (APR) 30 mg|Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.
11157938|NCT01925768|EG000|Reported Event|Placebo-Controlled Phase: Placebo (Weeks 0-24)|Participants who were randomized to placebo tablets twice daily (BID) during the double-blind, 24-week placebo-controlled phase.
11157939|NCT01925768|EG001|Reported Event|Placebo-Controlled Phase: Apremilast (Weeks 0-24)|Participants who were randomized to apremilast tablets twice daily during the double-blind, 24-week placebo-controlled phase.
11157940|NCT01925768|EG002|Reported Event|APR Exposure Period: Apremilast|Participants who received apremilast any point during the course of the study, on Day 0, 16 or Day 24 and continued to receive apremilast 30 mg tablets BID up to week 104.
11157941|NCT01925781|BG000|Baseline|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
11157942|NCT01925781|BG001|Baseline|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
11157943|NCT01925781|BG002|Baseline|Total|Total of all reporting groups
11157944|NCT01925781|FG000|Participant Flow|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
11157945|NCT01925781|FG001|Participant Flow|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
11157946|NCT01925781|OG000|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
11157947|NCT01925781|OG001|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
11157948|NCT01925781|EG000|Reported Event|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
11157949|NCT01925781|EG001|Reported Event|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
11157950|NCT01925950|BG000|Baseline|Placebo|"Control~Placebo"
11157951|NCT01925950|BG001|Baseline|orBec|"Investigational drug~orBec"
11157952|NCT01925950|BG002|Baseline|Total|Total of all reporting groups
11157953|NCT01925950|FG000|Participant Flow|Placebo|"Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.~Part 1: 2 mg of placebo 4 times per day for up to 16 weeks.~Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:~Weeks 17-24: 2 mg placebo 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg placebo 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg placebo daily, up to 16 weeks."
11157954|NCT01925950|FG001|Participant Flow|orBec|"orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.~Part 1: 2 mg of orBec 4 times per day for up to 16 weeks.~Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:~Weeks 17-24: 2 mg orBec 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg orBec 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg orBec daily, up to 16 weeks."
11157955|NCT01925950|OG000|Outcome|Placebo|"Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.~2 mg of placebo 4 times per day for up to 16 weeks."
11157956|NCT01925950|OG001|Outcome|orBec|"orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.~2 mg of orBec 4 times per day for up to 16 weeks."
11157957|NCT01925950|EG000|Reported Event|Placebo|"Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.~Part 1: 2 mg of placebo 4 times per day for up to 16 weeks.~Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:~Weeks 17-24: 2 mg placebo 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg placebo 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg placebo daily, up to 16 weeks."
11157958|NCT01925950|EG001|Reported Event|orBec|"orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.~Part 1: 2 mg of orBec 4 times per day for up to 16 weeks.~Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:~Weeks 17-24: 2 mg orBec 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg orBec 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg orBec daily, up to 16 weeks."
11157959|NCT01925989|BG000|Baseline|All T1DM|Participants with T1DM who received Insulin peglispro (LY260551) and insulin glargine SQ in either sequence group.
11157960|NCT01925989|BG001|Baseline|Control|Untreated healthy participants who received no study drug.
11157961|NCT01925989|BG002|Baseline|Total|Total of all reporting groups
10887756|NCT00502593|OG001|Outcome|Fluarix-C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
10887757|NCT00502593|OG001|Outcome|Fluarix-A 3-5Y Group|Fluarix-A 3-5Y Group
11157962|NCT01925989|FG000|Participant Flow|Sequence Insulin Peglispro/Insulin Glargine|Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen. Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.
11157963|NCT01925989|FG001|Participant Flow|Sequence Insulin Glargine/Insulin Peglispro|Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
11157964|NCT01925989|FG002|Participant Flow|Control|Untreated healthy participants who received no study drug.
11157965|NCT01925989|OG000|Outcome|Insulin Peglispro|Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
11157966|NCT01925989|OG001|Outcome|Insulin Glargine|Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
11157967|NCT01925989|OG002|Outcome|Control|Untreated healthy participants who received no study drug.
11157968|NCT01925989|OG000|Outcome|Control|Untreated healthy participants who received no study drug.
11157969|NCT01925989|OG001|Outcome|Insulin Glargine/Insulin Peglispro|Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen.
11157970|NCT01925989|OG000|Outcome|Insulin Peglispro|Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen.
11157971|NCT01925989|OG001|Outcome|Insulin Glargine|Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen.
11157972|NCT01925989|EG000|Reported Event|Insulin Peglispro|Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.
11157973|NCT01925989|EG001|Reported Event|Insulin Glargine|Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.
11157974|NCT01925989|EG002|Reported Event|Control|Control Arm. Untreated healthy participants.
11157975|NCT01926015|BG000|Baseline|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
11157976|NCT01926015|BG001|Baseline|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
11157977|NCT01926015|BG002|Baseline|Total|Total of all reporting groups
11157978|NCT01926015|FG000|Participant Flow|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
11157979|NCT01926015|FG001|Participant Flow|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
11157980|NCT01926015|OG000|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
11157981|NCT01926015|OG001|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
11157982|NCT01926015|EG000|Reported Event|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
11157983|NCT01926015|EG001|Reported Event|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
11157984|NCT01926028|BG000|Baseline|Placebo|"Placebo: aluminum hydroxide adjuvant~Placebo: 0.5 mL injection IM"
11157985|NCT01926028|BG001|Baseline|NDV-3A|"Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant~NDV-3A: 0.5mL injection IM"
11157986|NCT01926028|BG002|Baseline|NDV-3|"Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant~NDV-3: 0.5mL injection IM"
11157987|NCT01926028|BG003|Baseline|Total|Total of all reporting groups
11157988|NCT01926028|FG000|Participant Flow|Placebo|"Placebo: aluminum hydroxide and buffered saline~Placebo: 0.5 mL injection IM"
11157989|NCT01926028|FG001|Participant Flow|NDV-3A|"Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant~NDV-3A: 0.5mL injection IM"
11157990|NCT01926028|FG002|Participant Flow|NDV-3|"Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant~NDV-3: 0.5mL injection IM"
11157991|NCT01926028|OG000|Outcome|Placebo|"Placebo: aluminum hydroxide adjuvant~Placebo: 0.5 mL injection IM"
11157992|NCT01926028|OG001|Outcome|NDV-3A|"Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant~NDV-3A: 0.5mL injection IM"
11157993|NCT01926028|OG002|Outcome|NDV-3|"Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant~NDV-3: 0.5mL injection IM"
11157994|NCT01926028|OG000|Outcome|Placebo|"Placebo: aluminum hydroxide adjuvant~Placebo: 0.5mL injection IM"
11157995|NCT01926028|EG000|Reported Event|Placebo|"Placebo: aluminum hydroxide adjuvant~Placebo: 0.5mL injection IM"
11157996|NCT01926028|EG001|Reported Event|NDV-3A|"Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant~NDV-3A: 0.5mL injection IM"
11157997|NCT01926028|EG002|Reported Event|NDV-3|"Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant~NDV-3: 0.5mL injection IM"
11157998|NCT01926119|BG000|Baseline|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
11157999|NCT01926119|FG000|Participant Flow|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
11158000|NCT01926119|OG000|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
11158001|NCT01926119|EG000|Reported Event|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
11158002|NCT01926444|BG000|Baseline|GIC-1001 Low Dose|"GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158003|NCT01926444|BG001|Baseline|GIC-1001 Mid-dose|"GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158004|NCT01926444|BG002|Baseline|GIC-1001 , High Dose|"GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158005|NCT01926444|BG003|Baseline|GIC-1001 Matching Placebo|"Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158006|NCT01926444|BG004|Baseline|Total|Total of all reporting groups
11158007|NCT01926444|FG000|Participant Flow|GIC-1001 Low Dose|"GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158008|NCT01926444|FG001|Participant Flow|GIC-1001 Mid-dose|"GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158009|NCT01926444|FG002|Participant Flow|GIC-1001 , High Dose|"GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158010|NCT01926444|FG003|Participant Flow|GIC-1001 Matching Placebo|"Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11233874|NCT02431364|OG002|Outcome|Verdinexor 20 mg|Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.
11158011|NCT01926444|OG000|Outcome|GIC-1001 Low Dose|"GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158012|NCT01926444|OG001|Outcome|GIC-1001 Mid-dose|"GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158013|NCT01926444|OG002|Outcome|GIC-1001 , High Dose|"GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158014|NCT01926444|OG003|Outcome|GIC-1001 Matching Placebo|"Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158015|NCT01926444|EG000|Reported Event|GIC-1001 Low Dose|"GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158016|NCT01926444|EG001|Reported Event|GIC-1001 Mid-dose|"GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158017|NCT01926444|EG002|Reported Event|GIC-1001 , High Dose|"GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158018|NCT01926444|EG003|Reported Event|GIC-1001 Matching Placebo|"Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)~GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water"
11158019|NCT01926496|BG000|Baseline|Ingenol Mebutate|"Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8>~> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs."
11158020|NCT01926496|BG001|Baseline|Imiquimod|"Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8>~> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs"
11158021|NCT01926496|BG002|Baseline|Total|Total of all reporting groups
11158022|NCT01926496|FG000|Participant Flow|Ingenol Mebutate|"Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8>~> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs."
11158023|NCT01926496|FG001|Participant Flow|Imiquimod|"Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8>~> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs"
11158024|NCT01926496|OG000|Outcome|Ingenol Mebutate|"Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8>~> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs."
11158025|NCT01926496|OG001|Outcome|Imiquimod|"Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8>~> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs"
11158026|NCT01926496|OG000|Outcome|Ingenol Mebutate|"Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8 >~> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs."
11158027|NCT01926496|OG001|Outcome|Imiquimod|"Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected~> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8~>~> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs"
11158028|NCT01926496|EG000|Reported Event|Ingenol Mebutate Until Week 20|"Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8.~Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs."
11158029|NCT01926496|EG001|Reported Event|Imiquimod Until Week 20|Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8 Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
11158030|NCT01926496|EG002|Reported Event|Ingenol Mebutate After Week 20|Ingenol mebutate Week 20 is the first week of the follow-up period.
11158031|NCT01926496|EG003|Reported Event|Imiquimod After Week 20|Imiquimod Week 20 is the first week of the follow-up period.
11158032|NCT01926509|BG000|Baseline|MK-8892 Panel A|Participants were administered MK-8892 once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 3 mg (Days 15-21), 4 mg (Days 22-28).
11158033|NCT01926509|BG001|Baseline|MK-8892 Panel B|Participants were administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), 4 mg (Days 22-28).
11158034|NCT01926509|BG002|Baseline|MK-8892 Panel C|Participants were administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), up to 8 mg (Days 22-28).
11158035|NCT01926509|BG003|Baseline|Placebo (Panels A and B)|Participants were administered placebo to MK-8892 once daily for 28 days.
11158036|NCT01926509|BG004|Baseline|Total|Total of all reporting groups
11158037|NCT01926509|FG000|Participant Flow|MK-8892 Panel A|Participants were administered MK-8892 once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 3 mg (Days 15-21), 4 mg (Days 22-28).
11158038|NCT01926509|FG001|Participant Flow|MK-8892 Panel B|Participants were administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), 4 mg (Days 22-28).
11158039|NCT01926509|FG002|Participant Flow|MK-8892 Panel C|Participants were administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), up to 8 mg (Days 22-28).
11158040|NCT01926509|FG003|Participant Flow|Placebo (Panels A and B)|Participants were administered placebo to MK-8892 once daily for 28 days.
11158041|NCT01926509|OG000|Outcome|MK-8892 Panel A|Participants were administered MK-8892 once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 3 mg (Days 15-21), 4 mg (Days 22-28).
11158042|NCT01926509|OG001|Outcome|MK-8892 Panel B|Participants were administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), 4 mg (Days 22-28).
11158043|NCT01926509|OG002|Outcome|MK-8892 Panel C|Participants were administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), up to 8 mg (Days 22-28).
11158044|NCT01926509|OG003|Outcome|Placebo (Panels A and B)|Participants were administered placebo to MK-8892 once daily for 28 days.
11158045|NCT01926509|EG000|Reported Event|MK-8892 Panel A|Participants were administered MK-8892 once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 3 mg (Days 15-21), 4 mg (Days 22-28).
11158046|NCT01926509|EG001|Reported Event|MK-8892 Panel B|Participants were administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), 4 mg (Days 22-28).
11158047|NCT01926509|EG002|Reported Event|MK-8892 Panel C|Participants were administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), up to 8 mg (Days 22-28).
11158048|NCT01926509|EG003|Reported Event|Placebo (Panels A and B)|Participants were administered placebo to MK-8892 once daily for 28 days.
11158049|NCT01926626|BG000|Baseline|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
11158050|NCT01926626|FG000|Participant Flow|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
11158051|NCT01926626|OG000|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
11158052|NCT01926626|EG000|Reported Event|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
11158053|NCT01926782|BG000|Baseline|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
11158054|NCT01926782|BG001|Baseline|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158055|NCT01926782|BG002|Baseline|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158056|NCT01926782|BG003|Baseline|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
11158057|NCT01926782|BG004|Baseline|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158058|NCT01926782|BG005|Baseline|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158059|NCT01926782|BG006|Baseline|Total|Total of all reporting groups
11158060|NCT01926782|FG000|Participant Flow|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
11158061|NCT01926782|FG001|Participant Flow|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158062|NCT01926782|FG002|Participant Flow|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158063|NCT01926782|FG003|Participant Flow|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
11158064|NCT01926782|FG004|Participant Flow|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158065|NCT01926782|FG005|Participant Flow|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158066|NCT01926782|OG000|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
11158067|NCT01926782|OG001|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
11158068|NCT01926782|OG002|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158069|NCT01926782|OG000|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
11158070|NCT01926782|OG001|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
11158071|NCT01926782|OG002|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158072|NCT01926782|OG002|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
11158073|NCT01926782|OG001|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8"
11158074|NCT01926782|OG001|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158075|NCT01926782|OG001|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8"
11158076|NCT01926782|EG000|Reported Event|Placebo Q2W|Two SC injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks.
11158077|NCT01926782|EG001|Reported Event|Alirocumab 75 mg Q2W/Up 150 mg Q2W|One SC injection of Alirocumab 150 mg Q4W alternating with 2 SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158078|NCT01926782|EG002|Reported Event|Alirocumab 300 mg Q4W/Up 150 mg Q2W|Two SC injections of Alirocumab 300 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
11158079|NCT01926886|BG000|Baseline|Trastuzumab|Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
11158080|NCT01926886|FG000|Participant Flow|Trastuzumab|Participants received trastuzumab IV infusion at initial loading dose of 8 milligrams per kilogram (mg/kg) body weight (BW) for three-weekly (q3w) regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by subcutaneous (SC) administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
11158081|NCT01926886|FG001|Participant Flow|Health Care Professionals|HCPs included for polling purposes. HCPs were not enrolled in the study.
11158082|NCT01926886|OG000|Outcome|Trastuzumab|Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
11158083|NCT01926886|OG000|Outcome|Health Care Professionals|HCPs included for polling purposes. HCPs were not enrolled in the study.
11158084|NCT01926886|EG000|Reported Event|Trastuzumab|Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
11158085|NCT01926886|EG001|Reported Event|Health Care Professionals|HCPs included for polling purposes. HCPs were not enrolled in the study.
11158086|NCT01926977|BG000|Baseline|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
11158087|NCT01926977|BG001|Baseline|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
11158088|NCT01926977|BG002|Baseline|Total|Total of all reporting groups
11158089|NCT01926977|FG000|Participant Flow|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
11158090|NCT01926977|FG001|Participant Flow|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
11158091|NCT01926977|OG000|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
11158092|NCT01926977|OG001|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
11158093|NCT01926977|EG000|Reported Event|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
11158094|NCT01926977|EG001|Reported Event|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
11158095|NCT01927055|BG000|Baseline|Open-Label|Patients entered open label droxidopa dose titration, but did not proceed into the randomization phase.
11158096|NCT01927055|BG001|Baseline|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
11158097|NCT01927055|BG002|Baseline|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations. 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
11158098|NCT01927055|BG003|Baseline|Total|Total of all reporting groups
11158099|NCT01927055|FG000|Participant Flow|Open-label Titration|"Droxidopa 100 mg, 200 mg~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 2 weeks of treatment"
11158100|NCT01927055|FG001|Participant Flow|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
11158101|NCT01927055|FG002|Participant Flow|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
11158102|NCT01927055|OG000|Outcome|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: Droxidopa at 100 mg, 200 mg, 300 mg"
11158103|NCT01927055|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
11158104|NCT01927055|EG000|Reported Event|Open-label Titration|All patients treated with study drug during dose titration (1-14 days)
11158105|NCT01927055|EG001|Reported Event|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
11158106|NCT01927055|EG002|Reported Event|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
11158107|NCT01927120|BG000|Baseline|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
11158108|NCT01927120|FG000|Participant Flow|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
11158109|NCT01927120|OG000|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
11158110|NCT01927120|EG000|Reported Event|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
11158111|NCT01927341|BG000|Baseline|Phase 1b: Binimetinib + Panitumumab|Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.
11158112|NCT01927341|BG001|Baseline|Phase 2: Mutant RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.
11158113|NCT01927341|BG002|Baseline|Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.
11158114|NCT01927341|BG003|Baseline|Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.
11158115|NCT01927341|BG004|Baseline|Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
11158116|NCT01927341|BG005|Baseline|Total|Total of all reporting groups
11158117|NCT01927341|FG000|Participant Flow|Phase 1b: Binimetinib (MEK162) + Panitumumab|Participants received binimetinib 45 milligram (mg) orally twice daily with panitumumab 6 milligram per kilogram (mg/kg) intravenous (IV) infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.
11158118|NCT01927341|FG001|Participant Flow|Phase 2:Mutant RAS Epidermal Growth Factor Receptor Inhibitor(EGFRi)-Naive:Binimetinib + Panitumumab|Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.
11158119|NCT01927341|FG002|Participant Flow|Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.
11158120|NCT01927341|FG003|Participant Flow|Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.
11158121|NCT01927341|FG004|Participant Flow|Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
11158122|NCT01927341|OG000|Outcome|Phase 1b: Binimetinib + Panitumumab|Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.
11158123|NCT01927341|OG000|Outcome|Phase 2: Mutant RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.
11158124|NCT01927341|OG001|Outcome|Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.
11158125|NCT01927341|OG002|Outcome|Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.
11158126|NCT01927341|OG003|Outcome|Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
11158127|NCT01927341|OG001|Outcome|Phase 2: Mutant RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.
11158128|NCT01927341|OG002|Outcome|Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.
11158129|NCT01927341|OG003|Outcome|Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.
11158130|NCT01927341|OG004|Outcome|Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
11158131|NCT01927341|EG000|Reported Event|Phase 1b: Binimetinib + Panitumumab|Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.
11158132|NCT01927341|EG001|Reported Event|Phase 2: Mutant RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.
11158133|NCT01927341|EG002|Reported Event|Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.
11158134|NCT01927341|EG003|Reported Event|Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.
11158135|NCT01927341|EG004|Reported Event|Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab|Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
11158136|NCT01927367|BG000|Baseline|Clinical Decision Support System for AF|"Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).~Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care."
11158137|NCT01927367|BG001|Baseline|Usual Care|Usual Care - providers are not eligible to access / use the CDSS.
11158138|NCT01927367|BG002|Baseline|Total|Total of all reporting groups
11158139|NCT01927367|FG000|Participant Flow|Clinical Decision Support System for AF|"Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).~Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care."
11158140|NCT01927367|FG001|Participant Flow|Usual Care|Usual Care - providers are not eligible to access / use the CDSS.
11158141|NCT01927367|OG000|Outcome|Clinical Decision Support System for AF|"Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).~Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care."
11158142|NCT01927367|OG001|Outcome|Usual Care|Usual Care - providers are not eligible to access / use the CDSS.
11158143|NCT01927367|EG000|Reported Event|Clinical Decision Support System for AF|"Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).~Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care."
11158144|NCT01927367|EG001|Reported Event|Usual Care|Usual Care - providers are not eligible to access / use the CDSS.
11158145|NCT01927497|BG000|Baseline|Biological Mesh Closure|"Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection~Biological mesh assisted perineal closure: The eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm."
11158146|NCT01927497|BG001|Baseline|Primary Perineal Closure|"Primary perineal closure after extralevator abdomino perineal resection~Primary perineal closure: The perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon."
10887758|NCT00502593|OG000|Outcome|GSK1562902A -B Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11158147|NCT01927497|BG002|Baseline|Total|Total of all reporting groups
11158148|NCT01927497|FG000|Participant Flow|Biological Mesh Closure|"Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection~Biological mesh assisted perineal closure: The eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm."
11158149|NCT01927497|FG001|Participant Flow|Primary Perineal Closure|"Primary perineal closure after extralevator abdomino perineal resection~Primary perineal closure: The perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon."
11158150|NCT01927497|OG000|Outcome|Biological Mesh Closure|"Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection~Biological mesh assisted perineal closure: The eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm."
11158151|NCT01927497|OG001|Outcome|Primary Perineal Closure|"Primary perineal closure after extralevator abdomino perineal resection~Primary perineal closure: The perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon."
11158152|NCT01927497|EG000|Reported Event|Biological Mesh Closure|"Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection~Biological mesh assisted perineal closure: The eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm."
11158153|NCT01927497|EG001|Reported Event|Primary Perineal Closure|"Primary perineal closure after extralevator abdomino perineal resection~Primary perineal closure: The perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon."
11158154|NCT01927562|BG000|Baseline|Duodenal Treatment|Fractyl Duodenal Remodeling System
11158155|NCT01927562|FG000|Participant Flow|Duodenal Treatment|Fractyl Duodenal Remodeling System
11158156|NCT01927562|OG000|Outcome|Duodenal Treatment|Fractyl Duodenal Remodeling System
11158157|NCT01927562|EG000|Reported Event|Duodenal Treatment|Fractyl Duodenal Remodeling System
11158158|NCT01927575|BG000|Baseline|All Study Participants|"Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.~Standard X-Ray + CT: Standard of Care X-Ray Imaging + CT~Followed by Tomo Imaging"
11158159|NCT01927575|FG000|Participant Flow|All Study Participants|"Standard of care X-Ray imaging plus CT to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging + CT~Followed by Tomo Imaging"
11158160|NCT01927575|OG000|Outcome|Standard X-Ray|"Standard of care X-Ray imaging to be compared with research imaging device.~Followed by Tomo imaging~No AE's"
11158161|NCT01927575|OG001|Outcome|Standard CT|"Standard of care CT imaging to be compared with research imaging device.~Followed by Tomo imaging~No AE's"
11158162|NCT01927575|OG002|Outcome|Tomosynthesis|"Tomosynthesis imaging to be compared to standard of care CT and X-ray~No AEs"
11158163|NCT01927575|EG000|Reported Event|Standard X-Ray|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging"
11158164|NCT01927575|EG001|Reported Event|Standard CT|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging"
11158165|NCT01927575|EG002|Reported Event|Tomo|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging"
11158166|NCT01927627|BG000|Baseline|Enzalutamide|"Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).~enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD)."
11158167|NCT01927627|FG000|Participant Flow|Enzalutamide|"Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).~enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD)."
11158168|NCT01927627|OG000|Outcome|Enzalutamide|"Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).~enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD)."
11158169|NCT01927627|EG000|Reported Event|Enzalutamide|"Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).~enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD)."
11158170|NCT01927718|BG000|Baseline|Thalidomide + Lenalidomide|Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
11158171|NCT01927718|FG000|Participant Flow|Thalidomide + Lenalidomide|Thalidomide 100 mg by mouth daily for 28 days; Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
11158172|NCT01927718|OG000|Outcome|Thalidomide + Lenalidomide|Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
11158173|NCT01927718|EG000|Reported Event|Thalidomide + Lenalidomide|Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
11158174|NCT01927757|BG000|Baseline|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
11158175|NCT01927757|FG000|Participant Flow|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
11158176|NCT01927757|OG000|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
11158177|NCT01927757|OG000|Outcome|Presence of Anti-adalimumab Antibodies|Participants with anti-adalimumab antibodies.
11158178|NCT01927757|OG001|Outcome|Absence of Anti-adalimumab Antibodies|Participants with absence of anti-adalimumab antibodies.
11158179|NCT01927757|OG000|Outcome|Primary Failure|Participants failed to respond (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 3 months.
11158180|NCT01927757|OG001|Outcome|Secondary Failure|Participants who lost a satisfactory response (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 6 months.
11158181|NCT01927757|EG000|Reported Event|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
11158182|NCT01927861|BG000|Baseline|NN-220 0.033 mg/kg/Day|Participants received s.c. injection of NN-220, 0.033 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase).
11158183|NCT01927861|BG001|Baseline|NN-220 0.066 mg/kg/Day|Participants received s.c. injection of NN-220, 0.066 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase).
11158184|NCT01927861|BG002|Baseline|Total|Total of all reporting groups
11158185|NCT01927861|FG000|Participant Flow|NN-220 0.033 mg/kg/Day|Participants received subcutaneous (s.c.) injection of NN-220, 0.033 milligrams per kilogram per day (mg/kg/day) once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase).
11158186|NCT01927861|FG001|Participant Flow|NN-220 0.066 mg/kg/Day|Participants received s.c. injection of NN-220, 0.066 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase).
11158187|NCT01927861|OG000|Outcome|NN-220 0.033 mg/kg/Day|Participants received s.c. injection of NN-220, 0.033 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase).
11158188|NCT01927861|OG001|Outcome|NN-220 0.066 mg/kg/Day|Participants received s.c. injection of NN-220, 0.066 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase).
11158189|NCT01927861|EG000|Reported Event|0.033 mg/kg/Day|Participants received s.c. injection of NN-220, 0.033 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase).
11158190|NCT01927861|EG001|Reported Event|0.066 mg/kg/Day|Participants received s.c. injection of NN-220, 0.066 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase).
11158191|NCT01927887|BG000|Baseline|Nanoparticle Enhanced MRI|"Each subject will have one MRI scan at MGH. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed.The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
11158192|NCT01927887|FG000|Participant Flow|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols.Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec.
11228207|NCT02388737|EG001|Reported Event|Vonoprazan 20 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11158193|NCT01927887|OG000|Outcome|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|"Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
11158194|NCT01927887|OG000|Outcome|Nanoparticle MRI|Nanoparticle MRI: Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
11158195|NCT01927887|EG000|Reported Event|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|"Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
11158196|NCT01928030|BG000|Baseline|Hyaluronidase, Recombinant Human|Patients receive recombinant human hyaluronidase 450 units or 900 units SC on days 1, 3, 5, and 7 (Phase 1) and then on days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
11158197|NCT01928030|FG000|Participant Flow|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
11158198|NCT01928030|FG001|Participant Flow|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
11158199|NCT01928030|FG002|Participant Flow|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
11158200|NCT01928030|OG000|Outcome|450 Units Recombinant Human Hyaluronidase (rHuPH20)|Participants receive 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously (SC) on Days 1, 3, 5, and 7 (Phase 1) and then on Days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
11158201|NCT01928030|OG000|Outcome|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
11158202|NCT01928030|OG001|Outcome|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
11158203|NCT01928030|OG002|Outcome|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
11158204|NCT01928030|EG000|Reported Event|Recombinant Human Hyaluronidase|"Participants who received 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously in Phase 1 were assessed in this outcome measure, treatment-related adverse events.~Biomarker analysis and pharmacology study were performed during study.~recombinant human hyaluronidase: Given subcutaneously"
11158205|NCT01928186|BG000|Baseline|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
11158206|NCT01928186|FG000|Participant Flow|Diagnostic (FLT PET)|"Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.~Fluorothymidine F-18: Undergo FLT PET~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies"
11158207|NCT01928186|OG000|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
11158208|NCT01928186|EG000|Reported Event|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
11158209|NCT01928199|BG000|Baseline|Sitagliptin|"Sitaglipitin tablets will be administered orally for 3 months from randomization~Initial dose will be 100mg/daily, adjusted per renal function:~Creatinine clearance > or = 50mL/min: 100mg/day Creatinine clearance > or = 30 and <50mL/min: 50mg/day Creatinine clearance <30 mL/min or on dialysis: 25mg/day~Sitagliptin"
11158210|NCT01928199|BG001|Baseline|Placebo|"Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator~Placebo"
11158211|NCT01928199|BG002|Baseline|Total|Total of all reporting groups
11158212|NCT01928199|FG000|Participant Flow|Sitagliptin|"Sitaglipitin tablets will be administered orally for 3 months from randomization~Initial dose will be 100mg/daily, adjusted per renal function:~Creatinine clearance > or = 50mL/min: 100mg/day Creatinine clearance > or = 30 and <50mL/min: 50mg/day Creatinine clearance <30 mL/min or on dialysis: 25mg/day~Sitagliptin"
11233875|NCT02431364|OG003|Outcome|Verdinexor 40 mg|Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
11158213|NCT01928199|FG001|Participant Flow|Placebo|"Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator~Placebo"
11158214|NCT01928199|OG000|Outcome|Sitagliptin|"Sitaglipitin tablets will be administered orally for 3 months from randomization~Initial dose will be 100mg/daily, adjusted per renal function:~Creatinine clearance > or = 50mL/min: 100mg/day Creatinine clearance > or = 30 and <50mL/min: 50mg/day Creatinine clearance <30 mL/min or on dialysis: 25mg/day~Sitagliptin"
11158215|NCT01928199|OG001|Outcome|Placebo|"Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator~Placebo"
11158216|NCT01928199|EG000|Reported Event|Sitagliptin|"Sitaglipitin tablets will be administered orally for 3 months from randomization~Initial dose will be 100mg/daily, adjusted per renal function:~Creatinine clearance > or = 50mL/min: 100mg/day Creatinine clearance > or = 30 and <50mL/min: 50mg/day Creatinine clearance <30 mL/min or on dialysis: 25mg/day~Sitagliptin"
11158217|NCT01928199|EG001|Reported Event|Placebo|"Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator~Placebo"
11158218|NCT01928225|BG000|Baseline|Human Papillomavirus Vaccine|Participants receive the quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
11158219|NCT01928225|BG001|Baseline|Saline Placebo|The participants receive saline placebo at entry, week 4 and week 26.
11158220|NCT01928225|BG002|Baseline|Total|Total of all reporting groups
11158221|NCT01928225|FG000|Participant Flow|Human Papillomavirus Vaccine|"Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.~Human Papillomavirus vaccine: The participants receive the qHPV vaccine at entry, week 4 and week 26"
11158222|NCT01928225|FG001|Participant Flow|Saline Placebo|"The participants receive saline placebo at entry, week 4 and week 26.~Human Papillomavirus vaccine: The participants receive the qHPV vaccine at entry, week 4 and week 26"
10887759|NCT00502593|OG002|Outcome|GSK1562902A-B Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11158223|NCT01928225|OG000|Outcome|Human Papillomavirus Vaccine|Participants receive the quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
11158224|NCT01928225|OG001|Outcome|Saline Placebo|The participants receive saline placebo at entry, week 4 and week 26.
11158225|NCT01928225|OG000|Outcome|Human Papillomavirus Vaccine|Participants receive the experimental Human Papillomavirus vaccine at entry, week 4 and week 26.
11158226|NCT01928225|EG000|Reported Event|Human Papillomavirus Vaccine|Participants receive the experimental Human Papillomavirus vaccine at entry, week 4 and week 26.
11158227|NCT01928225|EG001|Reported Event|Saline Placebo|The participants receive saline placebo at entry, week 4 and week 26.
11158228|NCT01928290|BG000|Baseline|Arm A: FOLFIRINOX (HER2-negative)|"Irinotecan 180 mg/m2 IV on Days 1 & 15.~Oxaliplatin 85 mg/m2 IV on Days 1 & 15.~Leucovorin 400 mg/m2 IV on Days 1 & 15.~Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15."
11158229|NCT01928290|BG001|Baseline|Arm B: FOLFIRINOX & Trastuzumab (HER2-positive)|"Trastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles.~Irinotecan 180 mg/m2 IV on Days 1 & 15.~Oxaliplatin 85 mg/m2 IV on Days 1 & 15.~Leucovorin 400 mg/m2 IV on Days 1 & 15.~Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15."
11158230|NCT01928290|BG002|Baseline|Total|Total of all reporting groups
11158231|NCT01928290|FG000|Participant Flow|Arm A: FOLFIRINOX (HER2-negative)|"Irinotecan 180 mg/m2 IV on Days 1 & 15.~Oxaliplatin 85 mg/m2 IV on Days 1 & 15.~Leucovorin 400 mg/m2 IV on Days 1 & 15.~Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15."
11158232|NCT01928290|FG001|Participant Flow|Arm B: FOLFIRINOX & Trastuzumab (HER2-positive)|"Trastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles.~Irinotecan 180 mg/m2 IV on Days 1 & 15.~Oxaliplatin 85 mg/m2 IV on Days 1 & 15.~Leucovorin 400 mg/m2 IV on Days 1 & 15.~Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15."
11158233|NCT01928290|OG000|Outcome|Arm A: FOLFIRINOX (HER2-negative)|"Irinotecan 180 mg/m2 IV on Days 1 & 15.~Oxaliplatin 85 mg/m2 IV on Days 1 & 15.~Leucovorin 400 mg/m2 IV on Days 1 & 15.~Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15."
11158234|NCT01928290|OG001|Outcome|Arm B: FOLFIRINOX & Trastuzumab (HER2-positive)|"Trastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles.~Irinotecan 180 mg/m2 IV on Days 1 & 15.~Oxaliplatin 85 mg/m2 IV on Days 1 & 15.~Leucovorin 400 mg/m2 IV on Days 1 & 15.~Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15."
11158235|NCT01928290|EG000|Reported Event|Arm A: FOLFIRINOX (HER2-negative)|"Irinotecan 180 mg/m2 IV on Days 1 & 15.~Oxaliplatin 85 mg/m2 IV on Days 1 & 15.~Leucovorin 400 mg/m2 IV on Days 1 & 15.~Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15."
11158236|NCT01928290|EG001|Reported Event|Arm B: FOLFIRINOX & Trastuzumab (HER2-positive)|"Trastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles.~Irinotecan 180 mg/m2 IV on Days 1 & 15.~Oxaliplatin 85 mg/m2 IV on Days 1 & 15.~Leucovorin 400 mg/m2 IV on Days 1 & 15.~Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15."
11158237|NCT01928329|BG000|Baseline|Exenatide (Bydureon)|"2 mg, of drug administration 1 per week via subcutaneous self injection~Exenatide (Bydureon®)"
11158238|NCT01928329|BG001|Baseline|Placebo|"2 mg, 1 per week via subcutaneous placebo self injection~Placebo"
11158239|NCT01928329|BG002|Baseline|Total|Total of all reporting groups
11158240|NCT01928329|FG000|Participant Flow|Exenatide (Bydureon)|"2 mg, of drug administration 1 per week via subcutaneous self injection~Exenatide (Bydureon®)"
11158241|NCT01928329|FG001|Participant Flow|Placebo|"2 mg, 1 per week via subcutaneous placebo self injection~Placebo"
11158242|NCT01928329|OG000|Outcome|Exenatide (Bydureon)|"2 mg, of drug administration 1 per week via subcutaneous self injection~Exenatide (Bydureon®)"
11158243|NCT01928329|OG001|Outcome|Placebo|"2 mg, 1 per week via subcutaneous placebo self injection~Placebo"
11158244|NCT01928329|EG000|Reported Event|Exenatide (Bydureon)|"2 mg, of drug administration 1 per week via subcutaneous self injection~Exenatide (Bydureon®)"
11158245|NCT01928329|EG001|Reported Event|Placebo|"2 mg, 1 per week via subcutaneous placebo self injection~Placebo"
11158246|NCT01928381|BG000|Baseline|Overall Study|Overall Study - Starting with Part 1
11158247|NCT01928381|FG000|Participant Flow|Part 1 - Pain Training|Part 1 - Screening, Pain Training, placebo run-in eligibility for Part 2
11158248|NCT01928381|FG001|Participant Flow|Sequence 1|Sequence 1 - 1st placebo, 2nd pregabalin, 3rd AZD5213 + pregabalin
11158249|NCT01928381|FG002|Participant Flow|Sequence 2|Sequence 2 - 1st Placebo, 2nd AZD5213 + pregabalin, 3rd pregabalin
11158250|NCT01928381|FG003|Participant Flow|Sequence 3|Sequence 3 - 1st pregabalin, 2nd placebo, 3rd AZD5213 + pregabalin
11158251|NCT01928381|FG004|Participant Flow|Sequence 4|Sequence 4 - 1st pregabalin, 2nd AZD5213 + pregabalin, 3rd placebo
11158252|NCT01928381|FG005|Participant Flow|Sequence 5|Sequence 5 - 1st AZD5213 + pregabalin, 2nd placebo, 3rd pregabalin
11158253|NCT01928381|FG006|Participant Flow|Sequence 6|Sequence 6 - 1st AZD5213 + pregabalin, 2nd pregabalin, 3rd placebo
11158254|NCT01928381|OG000|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
11158255|NCT01928381|OG001|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
11158256|NCT01928381|OG002|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
11158257|NCT01928381|EG000|Reported Event|Part 1|Part 1 - Pain training + 1 week of single blind placebo
11158258|NCT01928381|EG001|Reported Event|Part 2 - Placebo|Part 2 - placebo crossover periods
11158259|NCT01928381|EG002|Reported Event|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
11158260|NCT01928381|EG003|Reported Event|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
11158261|NCT01928381|EG004|Reported Event|Overall Study|Overall Study: Part 1 and Part 2
11158262|NCT01928433|BG000|Baseline|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
11158263|NCT01928433|BG001|Baseline|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
11158264|NCT01928433|BG002|Baseline|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
11158265|NCT01928433|BG003|Baseline|Total|Total of all reporting groups
11158266|NCT01928433|FG000|Participant Flow|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
11158267|NCT01928433|FG001|Participant Flow|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
11158268|NCT01928433|FG002|Participant Flow|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
11158269|NCT01928433|OG000|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
11158270|NCT01928433|OG001|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
11158271|NCT01928433|OG002|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
11158272|NCT01928433|OG000|Outcome|Finafloxacin 5 Days|"Intervention:~Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.~Finafloxacin 800 mg tablets once daily: Administered as four 200 mg tablets~Ciprofloxacin placebo i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days~Ciprofloxacin placebo oral twice daily: Administered as two capsules."
11158273|NCT01928433|OG001|Outcome|Finafloxacin 10 Days|"Intervention:~Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.~Finafloxacin 800 mg tablets once daily: Administered as four 200 mg tablets~Ciprofloxacin placebo i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days~Ciprofloxacin placebo oral twice daily: Administered as two capsules."
11158274|NCT01928433|OG002|Outcome|Ciprofloxacin 10 Days|"Intervention:~Ciprofloxacin 400 mg i.v. twice daily and Finafloxacin placebo i.v. once daily Ciprofloxacin 500 mg oral twice daily and Finafloxacin placebo tablets once daily Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.~Finafloxacin placebo tablets once daily: Administered as four tablets~Ciprofloxacin 400 mg i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days~Ciprofloxacin 500 mg oral twice daily: Administered as two 250 mg capsules."
11158275|NCT01928433|EG000|Reported Event|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
11158276|NCT01928433|EG001|Reported Event|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
11158277|NCT01928433|EG002|Reported Event|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
11158278|NCT01928446|BG000|Baseline|Lithium|Lithium in the form of extended release lithium carbonate. Subjects will be started on 600 mg/day (300mg bid) until steady state at target plasma levels between 0.6 and 0.8 meq/liter is achieved. The lowest dose will be 300 mg/day. Lithium will be prescribed for the duration of follow-up (1 year).
11158279|NCT01928446|BG001|Baseline|Placebo|Placebo tablets will be given to the subjects for the duration of follow-up (1 year). Dose adjustments will mimic the intervention arm of the study
11158280|NCT01928446|BG002|Baseline|Total|Total of all reporting groups
11158281|NCT01928446|FG000|Participant Flow|Lithium|Lithium in the form of extended release lithium carbonate. Subjects will be started on 600 mg/day (300mg bid) until steady state at target plasma levels between 0.6 and 0.8 meq/liter is achieved. The lowest dose will be 300 mg/day. Lithium will be prescribed for the duration of follow-up (1 year).
11158282|NCT01928446|FG001|Participant Flow|Placebo|Placebo tablets will be given to the subjects for the duration of follow-up (1 year). Dose adjustments will mimic the intervention arm of the study
11158283|NCT01928446|OG000|Outcome|Lithium|Lithium in the form of extended release lithium carbonate. Subjects will be started on 600 mg/day (300mg bid) until steady state at target plasma levels between 0.6 and 0.8 meq/liter is achieved. The lowest dose will be 300 mg/day. Lithium will be prescribed for the duration of follow-up (1 year).
11158284|NCT01928446|OG001|Outcome|Placebo|Placebo tablets will be given to the subjects for the duration of follow-up (1 year). Dose adjustments will mimic the intervention arm of the study
11158285|NCT01928446|OG000|Outcome|Lithium (Compliance Per Protocol)|compliance with study medication, defined as taking 80% or more of their study medication
11158286|NCT01928446|OG001|Outcome|Placebo (Compliance Per Protocol)|compliance with study medication, defined as taking 80% or more of their study medication
11158287|NCT01928446|EG000|Reported Event|Lithium|Lithium in the form of extended release lithium carbonate. Subjects will be started on 600 mg/day (300mg bid) until steady state at target plasma levels between 0.6 and 0.8 meq/liter is achieved. The lowest dose will be 300 mg/day. Lithium will be prescribed for the duration of follow-up (1 year).
11158288|NCT01928446|EG001|Reported Event|Placebo|Placebo tablets will be given to the subjects for the duration of follow-up (1 year). Dose adjustments will mimic the intervention arm of the study
11158289|NCT01928472|BG000|Baseline|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
11158290|NCT01928472|BG001|Baseline|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158291|NCT01928472|BG002|Baseline|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158292|NCT01928472|BG003|Baseline|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
11158293|NCT01928472|BG004|Baseline|TOTAL|Total of all reporting groups
11158294|NCT01928472|FG000|Participant Flow|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
11158295|NCT01928472|FG001|Participant Flow|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158296|NCT01928472|FG002|Participant Flow|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158297|NCT01928472|FG003|Participant Flow|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
11158298|NCT01928472|OG000|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
11158299|NCT01928472|OG001|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158300|NCT01928472|OG002|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158301|NCT01928472|OG003|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
11158302|NCT01928472|EG000|Reported Event|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158303|NCT01928472|EG001|Reported Event|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158304|NCT01928472|EG002|Reported Event|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
11158305|NCT01928472|EG003|Reported Event|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
11158306|NCT01928472|EG004|Reported Event|TOTAL|Total of all reporting groups.
11158307|NCT01928485|BG000|Baseline|Arm A (Active Surveillance)|"Patients undergo active surveillance for 52 weeks.~active surveillance: Undergo active surveillance~laboratory biomarker analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11158308|NCT01928485|BG001|Baseline|Arm B (Sunphenon)|"Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.~Sunphenon: Given PO~laboratory biomarker analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11158309|NCT01928485|BG002|Baseline|Total|Total of all reporting groups
11233876|NCT02431364|EG000|Reported Event|Placebo|Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.
11158310|NCT01928485|FG000|Participant Flow|Arm A (Active Surveillance)|"Patients undergo active surveillance for 52 weeks.~active surveillance: Undergo active surveillance~laboratory biomarker analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11158311|NCT01928485|FG001|Participant Flow|Arm B (Sunphenon)|"Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.~Sunphenon: Given PO~laboratory biomarker analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11158312|NCT01928485|OG000|Outcome|Arm A (Active Surveillance)|"Patients undergo active surveillance for 52 weeks.~active surveillance: Undergo active surveillance~laboratory biomarker analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11158313|NCT01928485|OG001|Outcome|Arm B (Sunphenon)|"Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.~Sunphenon: Given PO~laboratory biomarker analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11158314|NCT01928485|EG000|Reported Event|Arm A (Active Surveillance)|"Patients undergo active surveillance for 52 weeks.~active surveillance: Undergo active surveillance~laboratory biomarker analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11158315|NCT01928485|EG001|Reported Event|Arm B (Sunphenon)|"Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.~Sunphenon: Given PO~laboratory biomarker analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11158316|NCT01928524|BG000|Baseline|DOS2W Dose Level 1A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/m2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered."
11158317|NCT01928524|BG001|Baseline|DOS3W Dose Level 1B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.~DOS3W: Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered."
11158318|NCT01928524|BG002|Baseline|DOS2W Dose Level 2A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered."
11158319|NCT01928524|BG003|Baseline|DOS2W Dose Level 3A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2W: Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered."
11158320|NCT01928524|BG004|Baseline|DOS2W Dose Level 4A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2W: Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered."
11158321|NCT01928524|BG005|Baseline|DOS3W Dose Level 2B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.~DOS3W: Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered."
11158322|NCT01928524|BG006|Baseline|DOS3W Dose Level 3B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.~DOS3W: Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered."
11158323|NCT01928524|BG007|Baseline|Total|Total of all reporting groups
11158324|NCT01928524|FG000|Participant Flow|DOS2w 1A|3 patients Docetaxel mg/m2 day 1: 30 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 30x2
11158325|NCT01928524|FG001|Participant Flow|DOS2w 2A|3 patients Docetaxel mg/m2 day 1: 30 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2
11158326|NCT01928524|FG002|Participant Flow|DOS 2w 3A|6 patients Docetaxel mg/m2 day 1: 40 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2
11158327|NCT01928524|FG003|Participant Flow|DOS2w 4A|6 patients Docetaxel mg/m2 day 1: 50 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2
11158328|NCT01928524|FG004|Participant Flow|DOS3w 1B|3 patients Docetaxel mg/m2 day 1: 40 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2
11158329|NCT01928524|FG005|Participant Flow|DOS3w 2B|8 patients Docetaxel mg/m2 day 1: 50 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2
11158330|NCT01928524|FG006|Participant Flow|DOS3w 3B|5 patients Docetaxel mg/m2 day 1: 60 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2
11158331|NCT01928524|OG000|Outcome|DOS2W 1A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/m2) will be given every 2nd week."
11158332|NCT01928524|OG001|Outcome|DOS2W 2A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week."
11158333|NCT01928524|OG002|Outcome|DOS2W 3A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2W: Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week."
11158334|NCT01928524|OG003|Outcome|DOS2W 4A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2W: Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week."
11158335|NCT01928524|OG004|Outcome|DOS3W 1B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.~DOS3W: Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week."
11158336|NCT01928524|OG005|Outcome|DOS3W 2B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.~DOS3W: Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week."
11158337|NCT01928524|OG006|Outcome|DOS3W 3B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.~DOS3W: Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week."
11158338|NCT01928524|EG000|Reported Event|DOS2w Dose Level 1A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2w: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/2) will be given every 2nd week.~Dose levels are described in the Participant Flow section."
11158339|NCT01928524|EG001|Reported Event|DOS2w Dose Level 2A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2w: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.~Dose levels are described in the Participant Flow section."
11158340|NCT01928524|EG002|Reported Event|DOS2w Dose Level 3A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2w: Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.~Dose levels are described in the Participant Flow section."
11158341|NCT01928524|EG003|Reported Event|DOS2w Dose Level 4A|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS2w: Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.~Dose levels are described in the Participant Flow section."
11158342|NCT01928524|EG004|Reported Event|DOS3w Dose Level 1B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.~DOS3w: Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week.~Dose levels are described in the Participant Flow section."
11158343|NCT01928524|EG005|Reported Event|DOS3w Dose Level 2B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS3w: Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week.~Dose levels are described in the Participant Flow section."
11158344|NCT01928524|EG006|Reported Event|DOS3w Dose Level 3B|"Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.~DOS3w: Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week.~Dose levels are described in the Participant Flow section."
11158345|NCT01928680|BG000|Baseline|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
11158346|NCT01928680|FG000|Participant Flow|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
11158347|NCT01928680|OG000|Outcome|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
11158348|NCT01928680|EG000|Reported Event|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
11158349|NCT01928693|BG000|Baseline|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158350|NCT01928693|BG001|Baseline|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158351|NCT01928693|BG002|Baseline|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158352|NCT01928693|BG003|Baseline|Total|Total of all reporting groups
11158353|NCT01928693|FG000|Participant Flow|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158354|NCT01928693|FG001|Participant Flow|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158355|NCT01928693|FG002|Participant Flow|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158356|NCT01928693|OG000|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158357|NCT01928693|OG001|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158358|NCT01928693|OG002|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158359|NCT01928693|EG000|Reported Event|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158360|NCT01928693|EG001|Reported Event|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158361|NCT01928693|EG002|Reported Event|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
11158362|NCT01928719|BG000|Baseline|Reduced Nicotine Content Cigarettes|"The experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.~Reduced Nicotine Content Cigarettes: Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette"
11158363|NCT01928719|BG001|Baseline|Same Nicotine Content Cigarettes|"The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)~Same Nicotine Content Cigarettes: about 11.6 mg nicotine per cigarette"
11158364|NCT01928719|BG002|Baseline|Total|Total of all reporting groups
11158365|NCT01928719|FG000|Participant Flow|Reduced Nicotine Content Cigarettes|The experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette
11158366|NCT01928719|FG001|Participant Flow|Same Nicotine Content Cigarettes|"The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)~Same Nicotine Content Cigarettes: about 11.6 mg nicotine per cigarette"
11158367|NCT01928719|OG000|Outcome|Reduced Nicotine Content Cigarettes|"The experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.~Reduced Nicotine Content Cigarettes: Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette"
11158368|NCT01928719|OG001|Outcome|Same Nicotine Content Cigarettes|"The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)~Same Nicotine Content Cigarettes: about 11.6 mg nicotine per cigarette"
11158369|NCT01928719|OG000|Outcome|All Participants|"The experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette.~The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)."
11158370|NCT01928719|OG000|Outcome|Reduced Nicotine Content Cigarettes|"the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.~Reduced Nicotine Content Cigarettes: Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette"
10887760|NCT00502593|OG002|Outcome|GSK1562902A-C Lot 3 6-9Y Group Subjects Aged 6-9 Years Receive|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11158371|NCT01928719|EG000|Reported Event|Reduced Nicotine Content Cigarettes|"The experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.~Reduced Nicotine Content Cigarettes: Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette"
11158372|NCT01928719|EG001|Reported Event|Same Nicotine Content Cigarettes|"The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)~Same Nicotine Content Cigarettes: about 11.6 mg nicotine per cigarette"
11158373|NCT01928758|BG000|Baseline|Reduced Nicotine Content Cigarettes|"The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks~Reduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content"
11158374|NCT01928758|BG001|Baseline|Usual Nicotine Content Cigarettes|"Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)~Usual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"
11158375|NCT01928758|BG002|Baseline|Total|Total of all reporting groups
11158376|NCT01928758|FG000|Participant Flow|Reduced Nicotine Content Cigarettes|"The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks~Reduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content"
11158377|NCT01928758|FG001|Participant Flow|Usual Nicotine Content Cigarettes|"Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)~Usual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"
11158378|NCT01928758|OG000|Outcome|Reduced Nicotine Content Cigarettes|"The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 7.4, 3.3, 1.4, 0.7 and 0.2 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks~Reduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content"
10887761|NCT00502593|EG000|Reported Event|GSK1562902A -A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11158379|NCT01928758|OG001|Outcome|Usual Nicotine Content Cigarettes|"Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)~Usual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"
11158380|NCT01928758|OG001|Outcome|Usual Nicotine Content Cigarettes|"Research cigarettes with a usual nicotine content (around 11.6mg per cigarette)~Usual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"
11158381|NCT01928758|EG000|Reported Event|Reduced Nicotine Content Cigarettes|"The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 8.6, 4.0, 1.8, 0.9 and 0.3 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks~Reduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content"
11158382|NCT01928758|EG001|Reported Event|Usual Nicotine Content Cigarettes|"Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)~Usual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes"
11158383|NCT01928771|BG000|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
11158384|NCT01928771|BG001|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
11158385|NCT01928771|BG002|Baseline|Placebo|Placebo administered subcutaneously
11158386|NCT01928771|BG003|Baseline|Total|Total of all reporting groups
11158387|NCT01928771|FG000|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
11158388|NCT01928771|FG001|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
11158389|NCT01928771|FG002|Participant Flow|Placebo|Placebo administered subcutaneously
11158390|NCT01928771|OG000|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
11158391|NCT01928771|OG001|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
11158392|NCT01928771|OG002|Outcome|Placebo|Placebo administered subcutaneously
11158393|NCT01928771|EG000|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
11158394|NCT01928771|EG001|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
11158395|NCT01928771|EG002|Reported Event|Placebo|Placebo administered subcutaneously
11158396|NCT01928797|BG000|Baseline|Control Group|cardiac output monitor will be attached CO values will not be used to guide vasopressor use. The care provider will use blood pressure and heart rate data to guide vasopressor use.
11158397|NCT01928797|BG001|Baseline|Study Group|cardiac output monitor will be attached CO values will guide vasopressor use in addition blood pressure and heart rate
11158398|NCT01928797|BG002|Baseline|Total|Total of all reporting groups
11158399|NCT01928797|FG000|Participant Flow|Control Group|Vasopressor use based on blood pressure and heart rate. Cardiac output data was blinded to the care providers.
11158400|NCT01928797|FG001|Participant Flow|Study Group|Vasopressor use based on the cardiac output, blood pressure and heart rate.
11158401|NCT01928797|OG000|Outcome|Control Group|cardiac output monitor will be attached but CO values will not guide vasopressor use as CO data is blinded to care provider
11158402|NCT01928797|OG001|Outcome|Study Group|cardiac output monitor will be attached and CO data used to guide management based on the protocol
11158403|NCT01928797|OG000|Outcome|Control Group|Vasopressor use based on the blood pressure changes and heart rate
11158404|NCT01928797|OG001|Outcome|Study Group|Vasopressor use based on the cardiac output, blood pressure and heart rate
11158405|NCT01928797|EG000|Reported Event|Control Group|cardiac output monitor will be attached but will not guide treatment based on cardiac output. The treatment will be based on blood pressure changes.
11158406|NCT01928797|EG001|Reported Event|Study Group|cardiac output monitor will be attached CO values will guide vasopressor protocol use
11158407|NCT01928849|BG000|Baseline|Cherry Syrup|"Cherry Syrup: Patients randomized to the Control arm of the trial will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and the placebo.~Cherry Syrup: Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid 250mg preoperatively, and then three times per day for 6 days post-operatively."
11158408|NCT01928849|BG001|Baseline|Valproic Acid|"Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid.~Valproic Acid: Intervention patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and oral valproic acid 250mg preoperatively, then three times per day for either 6 days post-operatively or until discharge from the hospital."
11158409|NCT01928849|BG002|Baseline|Total|Total of all reporting groups
11158410|NCT01928849|FG000|Participant Flow|Cherry Syrup|"Cherry Syrup: Patients randomized to the Control arm of the trial will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and the placebo.~Cherry Syrup: Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid 250mg preoperatively, and then three times per day for 6 days post-operatively."
11158411|NCT01928849|FG001|Participant Flow|Valproic Acid|"Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid.~Valproic Acid: Intervention patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and oral valproic acid 250mg preoperatively, then three times per day for either 6 days post-operatively or until discharge from the hospital."
11158412|NCT01928849|OG000|Outcome|Cherry Syrup|"Cherry Syrup: Patients randomized to the Control arm of the trial will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and the placebo.~Cherry Syrup: Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid 250mg preoperatively, and then three times per day for 6 days post-operatively."
11158413|NCT01928849|OG001|Outcome|Valproic Acid|"Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid.~Valproic Acid: Intervention patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and oral valproic acid 250mg preoperatively, then three times per day for either 6 days post-operatively or until discharge from the hospital."
11158414|NCT01928849|EG000|Reported Event|Cherry Syrup|"Cherry Syrup: Patients randomized to the Control arm of the trial will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and the placebo.~Cherry Syrup: Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid 250mg preoperatively, and then three times per day for 6 days post-operatively."
11158415|NCT01928849|EG001|Reported Event|Valproic Acid|"Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid.~Valproic Acid: Intervention patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and oral valproic acid 250mg preoperatively, then three times per day for either 6 days post-operatively or until discharge from the hospital."
11158416|NCT01928862|BG000|Baseline|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
11158417|NCT01928862|BG001|Baseline|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
11158418|NCT01928862|BG002|Baseline|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
11174313|NCT02020863|EG000|Reported Event|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
10887762|NCT00502593|EG001|Reported Event|Fluarix-A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11158419|NCT01928862|BG003|Baseline|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
11158420|NCT01928862|BG004|Baseline|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
11158421|NCT01928862|BG005|Baseline|Total|Total of all reporting groups
11158422|NCT01928862|FG000|Participant Flow|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
11158423|NCT01928862|FG001|Participant Flow|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
11158424|NCT01928862|FG002|Participant Flow|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
11158425|NCT01928862|FG003|Participant Flow|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
11158426|NCT01928862|FG004|Participant Flow|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
11158427|NCT01928862|OG000|Outcome|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
11158428|NCT01928862|OG001|Outcome|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
11158429|NCT01928862|OG002|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
11158430|NCT01928862|OG003|Outcome|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
11158431|NCT01928862|OG004|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
11158432|NCT01928862|OG002|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
11158433|NCT01928862|EG000|Reported Event|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
11158434|NCT01928862|EG001|Reported Event|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
11158435|NCT01928862|EG002|Reported Event|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
11158436|NCT01928862|EG003|Reported Event|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
11158437|NCT01928862|EG004|Reported Event|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
11158438|NCT01928927|BG000|Baseline|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
11158439|NCT01928927|BG001|Baseline|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
11158440|NCT01928927|BG002|Baseline|Total|Total of all reporting groups
11158441|NCT01928927|FG000|Participant Flow|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
11158442|NCT01928927|FG001|Participant Flow|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.~Control"
11158443|NCT01928927|OG000|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
11158444|NCT01928927|OG001|Outcome|Arm B: No Study Drug|"Participants received no study drug and will follow week 0-48 evaluation schedule.~Control"
11158445|NCT01928927|OG001|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
11158446|NCT01928927|OG001|Outcome|Arm B: No Study Drug|Participants received no study drug and followed the week 0-48 evaluation schedule.
11158447|NCT01928927|OG000|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
11158448|NCT01928927|OG001|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.~Control"
11158449|NCT01928927|EG000|Reported Event|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
11158450|NCT01928927|EG001|Reported Event|Arm B: No Study Drug|"Participants received no study drug and will follow week 0-48 evaluation schedule.~Control"
11158451|NCT01928940|BG000|Baseline|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158452|NCT01928940|BG001|Baseline|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158453|NCT01928940|BG002|Baseline|Total|Total of all reporting groups
11174314|NCT02020889|BG000|Baseline|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
11158454|NCT01928940|FG000|Participant Flow|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158455|NCT01928940|FG001|Participant Flow|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158456|NCT01928940|OG000|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158457|NCT01928940|OG000|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158458|NCT01928940|OG000|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158459|NCT01928940|EG000|Reported Event|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158460|NCT01928940|EG001|Reported Event|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
11158461|NCT01929018|BG000|Baseline|Exercise, Activity, and Self-management|"Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.~Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.~Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.~Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period."
11158462|NCT01929018|BG001|Baseline|Home and Phone Visit|No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
11158463|NCT01929018|BG002|Baseline|Total|Total of all reporting groups
11174315|NCT02020889|BG001|Baseline|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
11174316|NCT02020889|BG002|Baseline|Total|Total of all reporting groups
11174317|NCT02020889|FG000|Participant Flow|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
11174318|NCT02020889|FG001|Participant Flow|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
11349175|NCT04115358|OG002|Outcome|Ferric Sulfate|"0,1 ml to the orifice of the root canals of the primary molar~Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material."
11158464|NCT01929018|FG000|Participant Flow|Exercise, Activity, and Self-management|"Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.~Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.~Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.~Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period."
11158465|NCT01929018|FG001|Participant Flow|Home and Phone Visit|No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
11158466|NCT01929018|OG000|Outcome|Exercise, Activity, and Self-management|"Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.~Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.~Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.~Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period."
11158467|NCT01929018|OG001|Outcome|Home and Phone Visit|No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
11158468|NCT01929018|EG000|Reported Event|Exercise, Activity, and Self-management|"Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.~Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.~Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.~Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period."
11158469|NCT01929018|EG001|Reported Event|Home and Phone Visit|No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
11158470|NCT01929031|BG000|Baseline|Placebo Stage 1|One Placebo tablet after dental surgery
11158471|NCT01929031|BG001|Baseline|Caffeine Stage 1|One Caffeine 100mg tablet after dental surgery
11158472|NCT01929031|BG002|Baseline|Ibuprofen Stage 1|One Ibuprofen 400mg tablet after dental surgery
11158473|NCT01929031|BG003|Baseline|Ibuprofen/Caffeine Stage 1|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
11158474|NCT01929031|BG004|Baseline|Total|Total of all reporting groups
11158475|NCT01929031|FG000|Participant Flow|Ibuprofen/Caffeine - Ibuprofen/Caffeine|Study stage 1: One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen400mg/Caffeine 100mg tablet, while awake, over 5 days
11158476|NCT01929031|FG001|Participant Flow|Ibuprofen - Ibuprofen|Study stage 1: One Ibuprofen 400mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
11158477|NCT01929031|FG002|Participant Flow|Caffeine - Ibuprofen/Caffeine|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
11158478|NCT01929031|FG003|Participant Flow|Caffeine - Ibuprofen|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
11158479|NCT01929031|FG004|Participant Flow|Placebo - Ibuprofen/Caffeine|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
11158480|NCT01929031|FG005|Participant Flow|Placebo - Ibuprofen|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
11158481|NCT01929031|OG000|Outcome|Placebo|One Placebo tablet after dental surgery
11158482|NCT01929031|OG001|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
11158483|NCT01929031|OG002|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
11158484|NCT01929031|OG003|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
11158485|NCT01929031|EG000|Reported Event|Placebo|Placebo tablet
11158486|NCT01929031|EG001|Reported Event|Caffeine|Caffeine 100mg tablet
11158487|NCT01929031|EG002|Reported Event|Ibuprofen|Ibuprofen 400mg tablet
11158488|NCT01929031|EG003|Reported Event|Ibuprofen/Caffeine|Ibuprofen 400mg / Caffeine 100mg tablet
11158489|NCT01929044|BG000|Baseline|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
11158490|NCT01929044|BG001|Baseline|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
11158491|NCT01929044|BG002|Baseline|Total|Total of all reporting groups
11158492|NCT01929044|FG000|Participant Flow|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
11158493|NCT01929044|FG001|Participant Flow|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
11158494|NCT01929044|OG000|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
11158495|NCT01929044|OG001|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
11158496|NCT01929044|EG000|Reported Event|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
11158497|NCT01929044|EG001|Reported Event|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
11158498|NCT01929057|BG000|Baseline|Acne Patients|"This group consists of patients who have at least moderate to severe acne on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158499|NCT01929057|BG001|Baseline|Healthy Controls|"This group contains participants who do not have any active acne lesions on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158500|NCT01929057|BG002|Baseline|Total|Total of all reporting groups
11158501|NCT01929057|FG000|Participant Flow|Acne Patients|"This group consists of patients who have at least moderate to severe acne on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158502|NCT01929057|FG001|Participant Flow|Healthy Controls|"This group contains participants who do not have any active acne lesions on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158503|NCT01929057|OG000|Outcome|Healthy Controls|"This group contains participants who do not have any active acne lesions on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158504|NCT01929057|OG001|Outcome|Acne Patients|"This group consists of patients who have at least moderate to severe acne on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158505|NCT01929057|OG000|Outcome|Acne Patients|"This group consists of patients who have at least moderate to severe acne on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158506|NCT01929057|OG001|Outcome|Healthy Controls|"This group contains participants who do not have any active acne lesions on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158507|NCT01929057|EG000|Reported Event|Acne Patients|"This group consists of patients who have at least moderate to severe acne on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158508|NCT01929057|EG001|Reported Event|Healthy Controls|"This group contains participants who do not have any active acne lesions on their back~Skin biopsy: 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)~Blood draw: Approximately half a tube of blood will be drawn from all participants in the study"
11158509|NCT01929083|BG000|Baseline|Entire Study Population|n=15 subjects who completed the study
11158510|NCT01929083|FG000|Participant Flow|Progesterone First, Then Placebo|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
11158511|NCT01929083|FG001|Participant Flow|Placebo First, Then Progesterone|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
11158512|NCT01929083|OG000|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
11158513|NCT01929083|OG001|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
11158514|NCT01929083|EG000|Reported Event|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
11158515|NCT01929083|EG001|Reported Event|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
11158516|NCT01929109|BG000|Baseline|LY2409021 Control|Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158517|NCT01929109|BG001|Baseline|LY2409021 Mild Renal Impairment|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158518|NCT01929109|BG002|Baseline|LY2409021 Moderate Renal Impairment|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158519|NCT01929109|BG003|Baseline|LY2409021 Severe Renal Impairment|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158520|NCT01929109|BG004|Baseline|LY2409021 End Stage Renal Disease|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.
11158521|NCT01929109|BG005|Baseline|Total|Total of all reporting groups
11158522|NCT01929109|FG000|Participant Flow|LY2409021 Control|Healthy participants received a single 80 milligram (mg) dose of LY2409021 orally on Day 1 of the study.
11158523|NCT01929109|FG001|Participant Flow|LY2409021 Mild Renal Impairment|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158524|NCT01929109|FG002|Participant Flow|LY2409021 Moderate Renal Impairment|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158525|NCT01929109|FG003|Participant Flow|LY2409021 Severe Renal Impairment|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158526|NCT01929109|FG004|Participant Flow|LY2409021 End Stage Renal Disease|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1(Dialysis) of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 (Non Dialysis) of the study.
11158527|NCT01929109|OG000|Outcome|LY2409021 Control|Healthy participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
11158528|NCT01929109|OG001|Outcome|LY2409021 Mild Renal Impairment|Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
11158529|NCT01929109|OG002|Outcome|LY2409021 Moderate Renal Impairment|Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
11158530|NCT01929109|OG003|Outcome|LY2409021 Severe Renal Impairment|Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
11158531|NCT01929109|OG000|Outcome|LY2409021 End Stage Renal Disease (Dialysis)|Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study.
11158532|NCT01929109|OG001|Outcome|LY2409021 End Stage Renal Disease (Non-Dialysis)|Participants will receive 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.
11158533|NCT01929109|OG000|Outcome|LY2409021 End Stage Renal Disease (Dialysis)|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study.
11158534|NCT01929109|OG001|Outcome|LY2409021 End Stage Renal Disease (Non-Dialysis)|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.
11158535|NCT01929109|EG000|Reported Event|LY2409021 Control|Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158536|NCT01929109|EG001|Reported Event|LY2409021 Mild Renal Impairment|Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158537|NCT01929109|EG002|Reported Event|LY2409021 Moderate Renal Impairment|Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158538|NCT01929109|EG003|Reported Event|LY2409021 Severe Renal Impairment|Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study.
11158539|NCT01929109|EG004|Reported Event|LY2409021 End Stage Renal Disease|Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.
11173909|NCT02018887|BG001|Baseline|Part B: Placebo|Part B Multiple Ascending Dose (MAD): Participants were assigned to 1 of 5 dosing cohorts (Cohorts 3 - 7). Cohort 3 received either placebo or 20 mg LY2969822 QD, PO, for 14 days. Cohort 4 received either placebo or up to 40 mg LY2969822 QD, PO, for 14 days (Titration: 6 mg QD for 3 days; 20 mg QD for 2 days, and 40 mg QD for 9 days.) Cohort 5 received placebo or up to 80 mg LY2969822 QD, PO, for 14 days. (Titration: 6 mg QD for 2 days; 20 mg QD for 2 days; 40 mg QD for 2 days and 80 mg QD for 8 days.) Cohort 6 received either placebo or up to 80 mg LY2969822 BID, PO for 14 days. (Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.) Cohort 7 received either placebo or up to 40 mg LY2969822 BID, PO for 14 days with rapid titration. (Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, 40 mg BID for 12 days.)
11173910|NCT02018887|BG002|Baseline|Part B: Cohorts 3|Part B Multiple Ascending Dose (MAD): Participants were assigned to 1 of 5 dosing cohorts (Cohorts 3 - 7). Cohort 3 received either placebo or 20 mg LY2969822 QD, PO, for 14 days. Cohort 4 received either placebo or up to 40 mg LY2969822 QD, PO, for 14 days (Titration: 6 mg QD for 3 days; 20 mg QD for 2 days, and 40 mg QD for 9 days.) Cohort 5 received placebo or up to 80 mg LY2969822 QD, PO, for 14 days. (Titration: 6 mg QD for 2 days; 20 mg QD for 2 days; 40 mg QD for 2 days and 80 mg QD for 8 days.) Cohort 6 received either placebo or up to 80 mg LY2969822 BID, PO for 14 days. (Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.) Cohort 7 received either placebo or up to 40 mg LY2969822 BID, PO for 14 days with rapid titration. (Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, 40 mg BID for 12 days.)
11173911|NCT02018887|BG003|Baseline|Part B: Cohorts 4|Part B Multiple Ascending Dose (MAD): Participants were assigned to 1 of 5 dosing cohorts (Cohorts 3 - 7). Cohort 3 received either placebo or 20 mg LY2969822 QD, PO, for 14 days. Cohort 4 received either placebo or up to 40 mg LY2969822 QD, PO, for 14 days (Titration: 6 mg QD for 3 days; 20 mg QD for 2 days, and 40 mg QD for 9 days.) Cohort 5 received placebo or up to 80 mg LY2969822 QD, PO, for 14 days. (Titration: 6 mg QD for 2 days; 20 mg QD for 2 days; 40 mg QD for 2 days and 80 mg QD for 8 days.) Cohort 6 received either placebo or up to 80 mg LY2969822 BID, PO for 14 days. (Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.) Cohort 7 received either placebo or up to 40 mg LY2969822 BID, PO for 14 days with rapid titration. (Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, 40 mg BID for 12 days.)
11173912|NCT02018887|BG004|Baseline|Part B: Cohorts 5|Part B Multiple Ascending Dose (MAD): Participants were assigned to 1 of 5 dosing cohorts (Cohorts 3 - 7). Cohort 3 received either placebo or 20 mg LY2969822 QD, PO, for 14 days. Cohort 4 received either placebo or up to 40 mg LY2969822 QD, PO, for 14 days (Titration: 6 mg QD for 3 days; 20 mg QD for 2 days, and 40 mg QD for 9 days.) Cohort 5 received placebo or up to 80 mg LY2969822 QD, PO, for 14 days. (Titration: 6 mg QD for 2 days; 20 mg QD for 2 days; 40 mg QD for 2 days and 80 mg QD for 8 days.) Cohort 6 received either placebo or up to 80 mg LY2969822 BID, PO for 14 days. (Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.) Cohort 7 received either placebo or up to 40 mg LY2969822 BID, PO for 14 days with rapid titration. (Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, 40 mg BID for 12 days.)
11173913|NCT02018887|BG005|Baseline|Part B: Cohorts 6|Part B Multiple Ascending Dose (MAD): Participants were assigned to 1 of 5 dosing cohorts (Cohorts 3 - 7). Cohort 3 received either placebo or 20 mg LY2969822 QD, PO, for 14 days. Cohort 4 received either placebo or up to 40 mg LY2969822 QD, PO, for 14 days (Titration: 6 mg QD for 3 days; 20 mg QD for 2 days, and 40 mg QD for 9 days.) Cohort 5 received placebo or up to 80 mg LY2969822 QD, PO, for 14 days. (Titration: 6 mg QD for 2 days; 20 mg QD for 2 days; 40 mg QD for 2 days and 80 mg QD for 8 days.) Cohort 6 received either placebo or up to 80 mg LY2969822 BID, PO for 14 days. (Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.) Cohort 7 received either placebo or up to 40 mg LY2969822 BID, PO for 14 days with rapid titration. (Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, 40 mg BID for 12 days.)
11158540|NCT01929135|BG000|Baseline|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days.
11158541|NCT01929135|BG001|Baseline|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
11158542|NCT01929135|BG002|Baseline|Total|Total of all reporting groups
11158543|NCT01929135|FG000|Participant Flow|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days..
11158544|NCT01929135|FG001|Participant Flow|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
11158545|NCT01929135|OG000|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
11158546|NCT01929135|OG001|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
11158547|NCT01929135|OG000|Outcome|Atorvastatin Group|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
11158548|NCT01929135|OG001|Outcome|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
11158549|NCT01929135|EG000|Reported Event|Atorvastatin Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus medicated 2% atorvastatin dentifrice. Therapy was supplemented with oral hygiene instruction, indicating patients to brush with the dentifrice 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin dentifrice: fluoride dentifrice with 2% Atorvastatin (20 mg per ml)."
11158550|NCT01929135|EG001|Reported Event|Placebo Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus placebo dentifrice.Therapy was supplemented with oral hygiene instruction, indicating patients to brush with dentifrice 2 times a day for two minutes each time, for 30 days.~Non medicated dentifrice: fluoride dentifrice."
11158551|NCT01929226|BG000|Baseline|ETI-204|"Intravenously (IV), single dose~ETI-204: Monoclonal Antibody"
11158552|NCT01929226|BG001|Baseline|Placebo|"Intravenously (IV), single dose~Placebo: Placebo comparator"
11158553|NCT01929226|BG002|Baseline|Total|Total of all reporting groups
11158554|NCT01929226|FG000|Participant Flow|ETI-204|"Intravenously (IV), single dose~ETI-204: Monoclonal Antibody"
11158555|NCT01929226|FG001|Participant Flow|Placebo|"Intravenously (IV), single dose~Placebo: Placebo comparator"
11158556|NCT01929226|OG000|Outcome|ETI-204|"Participants were administered a single intravenous (IV) infusion of 16 mg/kg ETI-204 in 0.9% sterile sodium chloride in a total volume of 250 mL over 90 minutes. ,~Following a protocol amendment, 147(70%) participants were premedicated with 50 mg oral diphenhydramine approximately 30 minutes prior to the start of the infusion."
11158557|NCT01929226|OG001|Outcome|Placebo|"Participants were administered a single intravenous (IV) infusion of ETI-204 Placebo in 0.9% sterile sodium chloride in a total volume of 250 mL over 90 minutes. ,~Following a protocol amendment, 48(68.6%) participants were premedicated with 50 mg oral diphenhydramine approximately 30 minutes prior to the start of the infusion."
11158558|NCT01929226|OG000|Outcome|ETI-204|"Participants were administered a single intravenous (IV) infusion of 16 mg/kg ETI-204 in 0.9% sterile sodium chloride in a total volume of 250 mL over 90 minutes. ,~Following a protocol amendment, 147(70%) participants were premedicated with 50 mg oral diphenhydramine approximately 30"
11158559|NCT01929226|EG000|Reported Event|ETI-204|"Intravenously (IV), single dose~ETI-204: Monoclonal Antibody"
11158560|NCT01929226|EG001|Reported Event|Placebo|"Intravenously (IV), single dose~Placebo: Placebo comparator"
11158561|NCT01929291|BG000|Baseline|Boostrix Group|Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
11158562|NCT01929291|FG000|Participant Flow|Boostrix Group|Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
11158563|NCT01929291|OG000|Outcome|Boostrix Group|Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
11158564|NCT01929291|EG000|Reported Event|Boostrix Group|Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
11174319|NCT02020889|OG000|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
11174320|NCT02020889|OG001|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
11174321|NCT02020889|EG000|Reported Event|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
11158565|NCT01929317|BG000|Baseline|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158566|NCT01929317|BG001|Baseline|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158567|NCT01929317|BG002|Baseline|Total|Total of all reporting groups
11158568|NCT01929317|FG000|Participant Flow|Ropinirole CR - High Dose Group|Participants received ropinirole controlled released (CR) 16 milligrams (mg) administered orally once daily (OD) for 4 weeks in the Screening Phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24 mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
11158569|NCT01929317|FG001|Participant Flow|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg per day administered orally OD for 4 weeks in the Screening phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
11158570|NCT01929317|OG000|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158571|NCT01929317|OG001|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158572|NCT01929317|OG000|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11173914|NCT02018887|BG006|Baseline|Part B: Cohorts 7|Part B Multiple Ascending Dose (MAD): Participants were assigned to 1 of 5 dosing cohorts (Cohorts 3 - 7). Cohort 3 received either placebo or 20 mg LY2969822 QD, PO, for 14 days. Cohort 4 received either placebo or up to 40 mg LY2969822 QD, PO, for 14 days (Titration: 6 mg QD for 3 days; 20 mg QD for 2 days, and 40 mg QD for 9 days.) Cohort 5 received placebo or up to 80 mg LY2969822 QD, PO, for 14 days. (Titration: 6 mg QD for 2 days; 20 mg QD for 2 days; 40 mg QD for 2 days and 80 mg QD for 8 days.) Cohort 6 received either placebo or up to 80 mg LY2969822 BID, PO for 14 days. (Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.) Cohort 7 received either placebo or up to 40 mg LY2969822 BID, PO for 14 days with rapid titration. (Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, 40 mg BID for 12 days.)
11089210|NCT01522443|EG001|Reported Event|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
11089211|NCT01522456|BG000|Baseline|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
11089212|NCT01522456|FG000|Participant Flow|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
11089213|NCT01522456|OG000|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
11089214|NCT01522456|OG001|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
11089215|NCT01522456|OG000|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
11089216|NCT01522456|OG001|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
11089217|NCT01522456|OG002|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
11089218|NCT01522456|OG003|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
11089219|NCT01522456|EG000|Reported Event|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
11089220|NCT01522456|EG001|Reported Event|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
11089221|NCT01522456|EG002|Reported Event|Non-application Site|Adverse events occurring on non-application sites
11089222|NCT01522651|BG000|Baseline|Placebo|Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
11089223|NCT01522651|BG001|Baseline|Ranolazine 750 mg|Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
11089224|NCT01522651|BG002|Baseline|Dronedarone 225 mg|Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
11089225|NCT01522651|BG003|Baseline|Ranolazine 750 mg + Dronedarone 225 mg|Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
11089226|NCT01522651|BG004|Baseline|Ranolazine 750 mg + Dronedarone 150 mg|Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
11089227|NCT01522651|BG005|Baseline|Total|Total of all reporting groups
11089228|NCT01522651|FG000|Participant Flow|Placebo|Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
11089229|NCT01522651|FG001|Participant Flow|Ranolazine 750 mg|Ranolazine 750 milligrams (mg) tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
11089230|NCT01522651|FG002|Participant Flow|Dronedarone 225 mg|Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
11089231|NCT01522651|FG003|Participant Flow|Ranolazine 750 mg + Dronedarone 225 mg|Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
11089232|NCT01522651|FG004|Participant Flow|Ranolazine 750 mg + Dronedarone 150 mg|Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
11089233|NCT01522651|OG000|Outcome|Placebo|Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
11089234|NCT01522651|OG001|Outcome|Ranolazine 750 mg|Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
11089235|NCT01522651|OG002|Outcome|Dronedarone 225 mg|Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
11089236|NCT01522651|OG003|Outcome|Ranolazine 750 mg + Dronedarone 225 mg|Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
11089237|NCT01522651|OG004|Outcome|Ranolazine 750 mg + Dronedarone 150 mg|Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
11089238|NCT01522651|EG000|Reported Event|Placebo|Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
11089239|NCT01522651|EG001|Reported Event|Ranolazine 750 mg|Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
11089240|NCT01522651|EG002|Reported Event|Dronedarone 225 mg|Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
11089241|NCT01522651|EG003|Reported Event|Ranolazine 750 mg + Dronedarone 225 mg|Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
11089242|NCT01522651|EG004|Reported Event|Ranolazine 750 mg + Dronedarone 150 mg|Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
11089243|NCT01522703|BG000|Baseline|Broccoli Sprouts|
11089244|NCT01522703|BG001|Baseline|Alfalfa Sprouts (Placebo Control)|
11089245|NCT01522703|BG002|Baseline|Total|Total of all reporting groups
11089246|NCT01522703|FG000|Participant Flow|Broccoli Sprouts|ingestion of broccoli sprouts 3 consecutive days
11089247|NCT01522703|FG001|Participant Flow|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts 3 consecutive days
11089248|NCT01522703|OG000|Outcome|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts for 3 consecutive days
11089249|NCT01522703|OG001|Outcome|Broccoli Sprouts|ingestion of broccoli sprouts for 3 consecutive days
11089250|NCT01522703|EG000|Reported Event|Broccoli Sprouts|
11089251|NCT01522703|EG001|Reported Event|Alfalfa Sprouts (Placebo Control)|
11158573|NCT01929317|OG001|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158574|NCT01929317|OG001|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158575|NCT01929317|OG001|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158576|NCT01929317|EG000|Reported Event|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158577|NCT01929317|EG001|Reported Event|Ropinirole CR - Maintenance Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158578|NCT01929317|EG002|Reported Event|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158579|NCT01929317|EG003|Reported Event|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
11158580|NCT01929343|BG000|Baseline|Lidocaine Following Cue-induced Craving|"Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.~lidocaine following cue-induced craving: as described in Arm Description"
11089252|NCT01522755|BG000|Baseline|Patients Implanted With the CapsureFix MRI Pacing Lead|Patients implanted with the CapsureFix MRI pacing lead model 5086
11089253|NCT01522755|FG000|Participant Flow|Patients Implanted With the CapsureFix MRI Pacing Lead|Patients implanted with the CapsureFix MRI pacing lead model 5086
11089254|NCT01522755|OG000|Outcome|Implanting Physicians|Questionnaires on ease of implant, maneuverability of the catheter, and other variables were taken during this study.
11089255|NCT01522755|OG000|Outcome|Patients Implanted With the CapsureFix MRI Pacing Lead|Pacing system implant with the CapsureFix MRI pacing lead model 5086: Pacing system implant with the CapsureFix MRI pacing lead model 5086
11089256|NCT01522755|EG000|Reported Event|Patients Implanted With the CapsureFix MRI Pacing Lead|Patients implanted with the CapsureFix MRI pacing lead model 5086
11089257|NCT01522924|BG000|Baseline|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
11089258|NCT01522924|BG001|Baseline|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
11089259|NCT01522924|BG002|Baseline|Total|Total of all reporting groups
11089260|NCT01522924|FG000|Participant Flow|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
11089261|NCT01522924|FG001|Participant Flow|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
11089262|NCT01522924|OG000|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
11089263|NCT01522924|OG001|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
11089264|NCT01522924|EG000|Reported Event|Lecture Only|participated in lecture only
11089265|NCT01522924|EG001|Reported Event|Counseling/Debriefing|participated in counseling and debriefing sessions
11089266|NCT01522937|BG000|Baseline|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
11089267|NCT01522937|FG000|Participant Flow|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
11089268|NCT01522937|OG000|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
11089269|NCT01522937|EG000|Reported Event|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
11089270|NCT01522950|BG000|Baseline|Nebivolol|"5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~Nebivolol: 5 mg daily or 10 mg daily"
11089271|NCT01522950|BG001|Baseline|Atenolol|"25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~atenolol: 25 mg daily or 50 mg daily"
11089272|NCT01522950|BG002|Baseline|Placebo|"Continue for 1 month; dose titration to high dose placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~placebo: one tablet daily"
11089273|NCT01522950|BG003|Baseline|Total|Total of all reporting groups
11089274|NCT01522950|FG000|Participant Flow|Nebivolol|"5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~Nebivolol: 5 mg daily or 10 mg daily"
11089275|NCT01522950|FG001|Participant Flow|Atenolol|"25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~atenolol: 25 mg daily or 50 mg daily"
11089276|NCT01522950|FG002|Participant Flow|Placebo|"Continue for 1 month; dose titration to high dose placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~placebo: one tablet daily"
11158581|NCT01929343|BG001|Baseline|Lidocaine Following Neutral Stimulus|"Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.~lidocaine following neutral stimulus: as described in Arm Description"
11158582|NCT01929343|BG002|Baseline|Saline|"Saline will be administered at same volume of lidocaine in active arms.~saline: as described in Arm Description"
11158583|NCT01929343|BG003|Baseline|Total|Total of all reporting groups
11158584|NCT01929343|FG000|Participant Flow|Lidocaine Following Cue-induced Craving|"Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.~lidocaine following cue-induced craving: as described in Arm Description"
11158585|NCT01929343|FG001|Participant Flow|Lidocaine Following Neutral Stimulus|"Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.~lidocaine following neutral stimulus: as described in Arm Description"
11158586|NCT01929343|FG002|Participant Flow|Saline|"Saline will be administered at same volume of lidocaine in active arms.~saline: as described in Arm Description"
11158587|NCT01929343|OG000|Outcome|Lidocaine Following Cue-induced Craving|"Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.~lidocaine following cue-induced craving: as described in Arm Description"
11158588|NCT01929343|OG001|Outcome|Lidocaine Following Neutral Stimulus|"Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.~lidocaine following neutral stimulus: as described in Arm Description"
11158589|NCT01929343|OG002|Outcome|Saline|"Saline will be administered at same volume of lidocaine in active arms.~saline: as described in Arm Description"
11158590|NCT01929343|EG000|Reported Event|Lidocaine Following Cue-induced Craving|"Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.~lidocaine following cue-induced craving: as described in Arm Description"
11158591|NCT01929343|EG001|Reported Event|Lidocaine Following Neutral Stimulus|"Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.~lidocaine following neutral stimulus: as described in Arm Description"
11158592|NCT01929343|EG002|Reported Event|Saline|"Saline will be administered at same volume of lidocaine in active arms.~saline: as described in Arm Description"
11158593|NCT01929395|BG000|Baseline|Phase 1: Addition of Supine MRI to Conventional Imaging|Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
11158594|NCT01929395|BG001|Baseline|Phase 2: Addition of Supine MRI to Conventional Imaging|Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
11158595|NCT01929395|BG002|Baseline|Phase 2: Conventional Imaging (SOC)|Wire localized (group WL) partial mastectomy
11158596|NCT01929395|BG003|Baseline|Total|Total of all reporting groups
11158597|NCT01929395|FG000|Participant Flow|Phase 1: Addition of Supine MRI to Conventional Imaging|Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
11158598|NCT01929395|FG001|Participant Flow|Phase 2: Addition of Supine MRI to Conventional Imaging|Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
11158599|NCT01929395|FG002|Participant Flow|Phase 2: Conventional Imaging (SOC)|Wire localized (group WL) partial mastectomy
11158600|NCT01929395|OG000|Outcome|Phase 1: Addition of Supine MRI to Conventional Imaging|Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
11158601|NCT01929395|OG000|Outcome|Phase 2: Addition of Supine MRI to Conventional Imaging|Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
11158602|NCT01929395|OG001|Outcome|Phase 2: Conventional Imaging (SOC)|Wire localized (group WL) partial mastectomy
11158603|NCT01929395|EG000|Reported Event|Phase 1: Addition of Supine MRI to Conventional Imaging|Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
11158604|NCT01929395|EG001|Reported Event|Phase 2: Addition of Supine MRI to Conventional Imaging|Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
11158605|NCT01929395|EG002|Reported Event|Phase 2: Conventional Imaging (SOC)|Wire localized (group WL) partial mastectomy
11158606|NCT01929408|BG000|Baseline|All Patients|All patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
11158607|NCT01929408|FG000|Participant Flow|Acute Myeloid Leukemia (AML) & Myelodysplastic Syndrome (MDS)|All patients starting induction therapy for newly diagnosed AML or advanced MDS and followed over time
11158608|NCT01929408|OG000|Outcome|All Patients|All eligible patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
11158609|NCT01929408|EG000|Reported Event|All Patients|All eligible patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
11158610|NCT01929460|BG000|Baseline|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
11158611|NCT01929460|BG001|Baseline|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
11158612|NCT01929460|BG002|Baseline|Total|Total of all reporting groups
11158613|NCT01929460|FG000|Participant Flow|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
11089277|NCT01522950|OG000|Outcome|Nebivolol|"5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~Nebivolol: 5 mg daily or 10 mg daily"
11089278|NCT01522950|OG001|Outcome|Atenolol|"25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~atenolol: 25 mg daily or 50 mg daily"
11089279|NCT01522950|OG002|Outcome|Placebo|"Continue for 1 month; dose titration to high dose placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~placebo: one tablet daily"
11089280|NCT01522950|EG000|Reported Event|Nebivolol|"5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~Nebivolol: 5 mg daily or 10 mg daily"
11089281|NCT01522950|EG001|Reported Event|Atenolol|"25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~atenolol: 25 mg daily or 50 mg daily"
11089282|NCT01522950|EG002|Reported Event|Placebo|"Continue for 1 month; dose titration to high dose placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.~placebo: one tablet daily"
11089283|NCT01522963|BG000|Baseline|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089284|NCT01522963|BG001|Baseline|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089285|NCT01522963|BG002|Baseline|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089286|NCT01522963|BG003|Baseline|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089287|NCT01522963|BG004|Baseline|Total|Total of all reporting groups
11089288|NCT01522963|FG000|Participant Flow|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089289|NCT01522963|FG001|Participant Flow|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089290|NCT01522963|FG002|Participant Flow|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089291|NCT01522963|FG003|Participant Flow|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089292|NCT01522963|OG000|Outcome|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089293|NCT01522963|OG001|Outcome|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089294|NCT01522963|OG002|Outcome|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089295|NCT01522963|OG003|Outcome|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
11089296|NCT01522963|EG000|Reported Event|Nicotine Lozenge Prior to Stress Task|"Subjects will receive the nicotine lozenge at one of four time-points prior to the stress task at the first laboratory session and after the stress task at the second laboratory session~Nicotine lozenge 4 mg: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task"
11089297|NCT01522963|EG001|Reported Event|Nicotine Lozenge After Stress Task|"Subjects will receive the nicotine lozenge after the stress task during the first laboratory session and prior to the stress task at the second laboratory session~Nicotine lozenge 4 mg: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task"
11089298|NCT01523275|BG000|Baseline|Saline|"Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of isotonic saline in the radial incisions.~Saline application: Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention."
11089299|NCT01523275|BG001|Baseline|Mitomycin-C|"Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of MMC in the radial incisions.~Mitomycin -C: Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes."
11089300|NCT01523275|BG002|Baseline|Total|Total of all reporting groups
11089301|NCT01523275|FG000|Participant Flow|Mitomycin C|Endoscopic dilation with topical mitomycin C
11089302|NCT01523275|FG001|Participant Flow|Saline|Endoscopic dilation with topical saline
11089303|NCT01523275|OG000|Outcome|Saline|"Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of isotonic saline in the radial incisions.~Saline application: Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention."
11089304|NCT01523275|OG001|Outcome|Mitomycin-C|"Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of MMC in the radial incisions.~Mitomycin -C: Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes."
11233877|NCT02431364|EG001|Reported Event|Verdinexor 5 mg|Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.
11158614|NCT01929460|FG001|Participant Flow|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
11158615|NCT01929460|OG000|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
11158616|NCT01929460|OG001|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
11158617|NCT01929460|EG000|Reported Event|Drug (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
11158618|NCT01929460|EG001|Reported Event|Intervention Group|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
11158619|NCT01929473|BG000|Baseline|Blood Drawings (0 Day, 365 Day) and Questionnaires|
11158620|NCT01929473|FG000|Participant Flow|Blood Drawings (0 Day, 365 Day) and Questionnaires|
11158621|NCT01929473|OG000|Outcome|Blood Drawings (0 Day, 365 Day) and Questionnaires|
11158622|NCT01929473|EG000|Reported Event|Blood Drawings (0 Day, 365 Day) and Questionnaires|
11158623|NCT01929642|BG000|Baseline|Everolimus or Sirolimus|Medication choice
11158624|NCT01929642|FG000|Participant Flow|Sirolimus or Everolimus|"Oral solution or tablet,titrated to therapeutic serum trough range (sirolimus); Oral tablet, titrated to therapeutic serum trough range (everolimus)~Sirolimus~Everolimus"
11158625|NCT01929642|OG000|Outcome|Everolimus or Sirolimus|Medication
11158626|NCT01929642|OG000|Outcome|Everolimus or Sirolimus|Medication choice
11158627|NCT01929642|OG000|Outcome|Everolimus or Sirolimus|
11158628|NCT01929642|EG000|Reported Event|Everolimus|
11158629|NCT01929681|BG000|Baseline|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
11158630|NCT01929681|BG001|Baseline|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
11158631|NCT01929681|BG002|Baseline|Total|Total of all reporting groups
11158632|NCT01929681|FG000|Participant Flow|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
11158633|NCT01929681|FG001|Participant Flow|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
11158634|NCT01929681|OG000|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
11158635|NCT01929681|OG001|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
11158636|NCT01929681|EG000|Reported Event|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
11158637|NCT01929681|EG001|Reported Event|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
11158638|NCT01929707|BG000|Baseline|LY3050258 or Placebo|Participants received doses of 2, 6, or 20 mg LY3050258 or placebo during Period 1 by topical administration on the trunk. Participants received 60, 200 mg LY3050258 or placebo on the trunk or 20 mg LY3050258 or placebo by topical administration on the axilla during Period 2. There were at least 7 days between treatments.
11158639|NCT01929707|FG000|Participant Flow|2 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 2 milligrams (mg) LY3050258.
11158640|NCT01929707|FG001|Participant Flow|6 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 6 mg LY3050258.
11158641|NCT01929707|FG002|Participant Flow|20 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 20 mg LY3050258
11158642|NCT01929707|FG003|Participant Flow|Placebo (Trunk)|Period 1 or 2: Healthy participants received a topical application of placebo.
11158643|NCT01929707|FG004|Participant Flow|60 mg LY3050258 (Trunk)|Period 2: Healthy participants received a topical application of 60 mg LY3050258.
11158644|NCT01929707|FG005|Participant Flow|200 mg LY3050258 (Trunk)|Period 2: Healthy participants received a topical application of 200 mg LY3050258.
11233878|NCT02431364|EG002|Reported Event|Verdinexor 10 mg|Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.
11089305|NCT01523275|EG000|Reported Event|Saline|"Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of isotonic saline in the radial incisions.~Saline application: Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention."
11089306|NCT01523275|EG001|Reported Event|Mitomycin-C|"Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of MMC in the radial incisions.~Mitomycin -C: Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes."
11089307|NCT01523301|BG000|Baseline|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
11089308|NCT01523301|BG001|Baseline|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
11089309|NCT01523301|BG002|Baseline|Total Title|
11089310|NCT01523301|FG000|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
11089311|NCT01523301|FG001|Participant Flow|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
11089312|NCT01523301|OG000|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
11089313|NCT01523301|OG001|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
11089314|NCT01523301|EG000|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
11089315|NCT01523301|EG001|Reported Event|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
11089316|NCT01523366|BG000|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
11233879|NCT02431364|EG003|Reported Event|Verdinexor 20 mg|Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.
11158645|NCT01929707|FG006|Participant Flow|20 mg LY3050258 (Axilla)|Period 2: Healthy participants received a topical application of 20 mg LY3050258.
11158646|NCT01929707|FG007|Participant Flow|Placebo (Axilla)|Period 2: Healthy participants received a topical application of placebo.
11158647|NCT01929707|OG000|Outcome|2 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 2 mg LY3050258.
11158648|NCT01929707|OG001|Outcome|6 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 6 mg LY3050258.
11158649|NCT01929707|OG002|Outcome|20 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 20 mg LY3050258.
11158650|NCT01929707|OG003|Outcome|Placebo (Trunk)|Period 1 or 2: Healthy participants received a topical application of placebo.
11158651|NCT01929707|OG004|Outcome|60 mg LY3050258 (Trunk)|Period 2: Healthy participants received a topical application of 60 mg LY3050258.
11158652|NCT01929707|OG005|Outcome|200 mg LY3050258 (Trunk)|Period 2: Healthy participants received a topical application of 200 mg LY3050258.
11158653|NCT01929707|OG006|Outcome|20 mg LY3050258 (Axilla)|Period 2: Healthy participants received a topical application of 20 mg LY3050258.
11158654|NCT01929707|OG007|Outcome|Placebo (Axilla)|Period 2: Healthy participants received a topical application of placebo.
11158655|NCT01929707|OG003|Outcome|60 mg LY3050258 (Trunk)|Period 2: Healthy participants received a topical application of 60 mg LY3050258.
11158656|NCT01929707|OG004|Outcome|200 mg LY3050258 (Trunk)|Period 2: Healthy participants received a topical application of 200 mg LY3050258.
10887763|NCT00502593|EG002|Reported Event|GSK1562902A-A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11158657|NCT01929707|OG005|Outcome|20 mg LY3050258 (Axilla)|Period 2: Healthy participants received a topical application of 20 mg LY3050258.
11158658|NCT01929707|EG000|Reported Event|2 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 2 mg LY3050258.
11158659|NCT01929707|EG001|Reported Event|6 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 6 mg LY3050258.
11158660|NCT01929707|EG002|Reported Event|20 mg LY3050258 (Trunk)|Period 1: Healthy participants received a topical application of 20 mg LY3050258.
11158661|NCT01929707|EG003|Reported Event|20 mg LY3050258 (Axilla)|Period 2: Healthy participants received a topical application of 20 mg LY3050258.
11158662|NCT01929707|EG004|Reported Event|60 mg LY3050258 (Trunk)|Period 2: Healthy participants received a topical application of 60 mg LY3050258.
11158663|NCT01929707|EG005|Reported Event|200 mg LY3050258 (Trunk)|Period 2: Healthy participants received a topical application of 200 mg LY3050258.
11158664|NCT01929707|EG006|Reported Event|Placebo (Trunk)|Period 1 or 2: Healthy participants received a topical application of placebo.
11158665|NCT01929707|EG007|Reported Event|Placebo (Axilla)|Period 2: Healthy participants received a topical application of placebo.
11158666|NCT01929759|BG000|Baseline|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
11158667|NCT01929759|FG000|Participant Flow|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
11158668|NCT01929759|OG000|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
11158669|NCT01929759|EG000|Reported Event|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
11158670|NCT01929863|BG000|Baseline|All Study Participants|In each treatment period, participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 or oral dose of treatment B-metformin 850 mg tablet BID plus matchig placebo to GSK2330672 tablet BID for 7 days according to a plan of randomization. The two treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
11158671|NCT01929863|FG000|Participant Flow|Metformin and GSK2330672, Then Placebo and Metformin|Participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 according to a plan of randomization. After a washout period of 13 to 15 days, participants received oral dose of treatment B-metformin 850 mg tablet BID plus matching placebo to GSK2330672 tablet BID for 7 days. During the washout period, participants received metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
11158672|NCT01929863|FG001|Participant Flow|Placebo and Metformin, Then Metformin and GSK2330672|Participants received oral dose of treatment B-metformin 850 mg tablet BID plus matching placebo to GSK2330672 tablet BID for 7 days according to a plan of randomization. After a washout period of 13 to 15 days, participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7. During the washout period, participants received metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
11174322|NCT02020889|EG001|Reported Event|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
11158673|NCT01929863|OG000|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
11158674|NCT01929863|OG001|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
11158675|NCT01929863|OG000|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
11158676|NCT01929863|OG001|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
11158677|NCT01929863|OG002|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
11158678|NCT01929863|OG001|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matchig placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
11158679|NCT01929863|OG001|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matchig placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
11158680|NCT01929863|EG000|Reported Event|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up
11158681|NCT01929863|EG001|Reported Event|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
11158682|NCT01929876|BG000|Baseline|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
11158683|NCT01929876|FG000|Participant Flow|Cobimetinib + Itraconazole|Cobimetinib 10 milligram (mg) (two 5 mg capsules) administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
11158684|NCT01929876|OG000|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
11158685|NCT01929876|EG000|Reported Event|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
11158686|NCT01929889|BG000|Baseline|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
11158687|NCT01929889|FG000|Participant Flow|A Single Arm, Open Label, Exploratory Study|This is a single arm, open label, exploratory study to examine effects of Fanapt (iloperadone) on social cognition. Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
11089317|NCT01523366|BG001|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
11089318|NCT01523366|BG002|Baseline|Total|Total of all reporting groups
11089319|NCT01523366|FG000|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
11089320|NCT01523366|FG001|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
11089321|NCT01523366|OG000|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
11089322|NCT01523366|OG001|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
11233880|NCT02431364|EG004|Reported Event|Verdinexor 40 mg|Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
11089323|NCT01523366|OG000|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
11089324|NCT01523366|OG001|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
11089325|NCT01523366|EG000|Reported Event|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
11089326|NCT01523366|EG001|Reported Event|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
11089327|NCT01523392|BG000|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 2)
11089328|NCT01523392|BG001|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
11089329|NCT01523392|BG002|Baseline|Total|Total of all reporting groups
11089330|NCT01523392|FG000|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2)
11089331|NCT01523392|FG001|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
11089332|NCT01523392|OG000|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
11089333|NCT01523392|OG001|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
11089334|NCT01523392|OG000|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
11089335|NCT01523392|OG001|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
11089336|NCT01523392|EG000|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
11089337|NCT01523392|EG001|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
11158688|NCT01929889|OG000|Outcome|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
11158689|NCT01929889|EG000|Reported Event|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
11158690|NCT01929980|BG000|Baseline|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
11158691|NCT01929980|FG000|Participant Flow|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
11158692|NCT01929980|OG000|Outcome|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
11158693|NCT01929980|EG000|Reported Event|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
11158694|NCT01929993|BG000|Baseline|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone (SWETZ) is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
11158695|NCT01929993|BG001|Baseline|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large loop excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
11158696|NCT01929993|BG002|Baseline|Total|Total of all reporting groups
10887764|NCT00502593|EG003|Reported Event|Fluarix-A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11158697|NCT01929993|FG000|Participant Flow|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode to remove the dysplastic epithelium of the cervix.
11158698|NCT01929993|FG001|Participant Flow|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large Loop Excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
11158699|NCT01929993|OG000|Outcome|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.~SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
11158700|NCT01929993|OG001|Outcome|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.~LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
11158701|NCT01929993|EG000|Reported Event|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.~SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
11158702|NCT01929993|EG001|Reported Event|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.~LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
11158703|NCT01930045|BG000|Baseline|All Participants|All enrolled participants
11158704|NCT01930045|FG000|Participant Flow|Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
11158705|NCT01930045|FG001|Participant Flow|MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
11158706|NCT01930045|FG002|Participant Flow|Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
11158707|NCT01930045|FG003|Participant Flow|Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
11158708|NCT01930045|FG004|Participant Flow|MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
11158709|NCT01930045|FG005|Participant Flow|Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
11158710|NCT01930045|OG000|Outcome|Raltegravir|400 mg Raltegravir alone
11158711|NCT01930045|OG001|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
11158712|NCT01930045|OG002|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
11158713|NCT01930045|OG001|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
11158714|NCT01930045|OG002|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
11158715|NCT01930045|EG000|Reported Event|Raltegravir|400 mg Raltegravir alone
11158716|NCT01930045|EG001|Reported Event|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
11158717|NCT01930045|EG002|Reported Event|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
11158718|NCT01930045|EG003|Reported Event|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
11158719|NCT01930045|EG004|Reported Event|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
11158720|NCT01930058|BG000|Baseline|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
11158721|NCT01930058|BG001|Baseline|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
11158722|NCT01930058|BG002|Baseline|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
11158723|NCT01930058|BG003|Baseline|Total|Total of all reporting groups
11158724|NCT01930058|FG000|Participant Flow|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
11158725|NCT01930058|FG001|Participant Flow|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
11158726|NCT01930058|FG002|Participant Flow|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
11158727|NCT01930058|OG000|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
11158728|NCT01930058|OG001|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
11158729|NCT01930058|OG002|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
11158730|NCT01930058|EG000|Reported Event|MK-8876 150 mg|All HCV GT3 participants treated with MK-8876 150 mg are included.
11158731|NCT01930058|EG001|Reported Event|MK-8876 800 mg|All HCV GT1a and GT3 participants treated with MK-8876 800 mg are included.
11158732|NCT01930162|BG000|Baseline|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
11158733|NCT01930162|FG000|Participant Flow|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
11158734|NCT01930162|OG000|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
11158735|NCT01930162|EG000|Reported Event|Time Period From Transplant Until 48hrs After Transplant|Adverse events that occurred within the first 48 hours of transplant.
11158736|NCT01930162|EG001|Reported Event|Time Period From Day 3 up to End of Study|Adverse Events that occurred 48 hours post-transplant.
11158737|NCT01930175|BG000|Baseline|VAY736 3 mg/kg|single dose iv of VAY736 at a dose of 3mg/kg
11158738|NCT01930175|BG001|Baseline|VAY736 10 mg/kg|single dose iv of VAY736 at a dose of 10mg/kg initiated following a safety review of patients receiving VAY736 3 mg/kg or placebo
11158739|NCT01930175|BG002|Baseline|Placebo|single dose iv of Placebo
11158740|NCT01930175|BG003|Baseline|Total|Total of all reporting groups
11158741|NCT01930175|FG000|Participant Flow|VAY736 3 mg/kg|single dose iv of VAY736 at a dose of 3mg/kg
11158742|NCT01930175|FG001|Participant Flow|VAY736 10 mg/kg|single dose iv of VAY736 at a dose of 10mg/kg initiated following a safety review of patients receiving VAY736 3 mg/kg or placebo
11158743|NCT01930175|FG002|Participant Flow|Placebo|single dose iv of Placebo
11158744|NCT01930175|OG000|Outcome|VAY736 3 mg/kg|single dose iv of VAY736 at a dose of 3mg/kg
11158745|NCT01930175|OG001|Outcome|VAY736 10 mg/kg|single dose iv of VAY736 at a dose of 10mg/kg initiated following a safety review of patients receiving VAY736 3 mg/kg or placebo
11158746|NCT01930175|OG002|Outcome|Placebo|single dose iv of Placebo
11158747|NCT01930175|EG000|Reported Event|VAY736 3 mg/kg|single dose iv of VAY736 at a dose of 3mg/kg
11158748|NCT01930175|EG001|Reported Event|VAY736 10 mg/kg|single dose iv of VAY736 at a dose of 10mg/kg initiated following a safety review of patients receiving VAY736 3 mg/kg or placebo
11158749|NCT01930175|EG002|Reported Event|Placebo|single dose iv of Placebo
11158750|NCT01930175|EG003|Reported Event|Open Label VAY736 10 mg/kg|Patients randomized to placebo in period 1 received open label VAY736 10mg/kg at week 24.
11158751|NCT01930188|BG000|Baseline|Semaglutide 0.5 mg + Sitagliptin Placebo|Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
11158752|NCT01930188|BG001|Baseline|Semaglutide 1.0 mg + Sitagliptin Placebo|Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
11158753|NCT01930188|BG002|Baseline|Sitagliptin + Semaglutide Placebo|Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
11158754|NCT01930188|BG003|Baseline|Total|Total of all reporting groups
11158755|NCT01930188|FG000|Participant Flow|Semaglutide 0.5 mg + Sitagliptin Placebo|Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
11158756|NCT01930188|FG001|Participant Flow|Semaglutide 1.0 mg + Sitagliptin Placebo|Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
11158757|NCT01930188|FG002|Participant Flow|Sitagliptin + Semaglutide Placebo|Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
11158758|NCT01930188|OG000|Outcome|Semaglutide 0.5 mg + Sitagliptin Placebo|Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
11158759|NCT01930188|OG001|Outcome|Semaglutide 1.0 mg + Sitagliptin Placebo|Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
11158760|NCT01930188|OG002|Outcome|Sitagliptin + Semaglutide Placebo|Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
11158761|NCT01930188|EG000|Reported Event|Semaglutide 1.0 mg + Sitagliptin Placebo|Semaglutide 1.0 mg once-weekly + Sitagliptin placebo once-daily
11158762|NCT01930188|EG001|Reported Event|Semaglutide 0.5 mg + Sitagliptin Placebo|Semaglutide 0.5 mg once-weekly + Sitagliptin placebo once-daily
11158763|NCT01930188|EG002|Reported Event|Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg|Sitagliptin 100 mg once-daily + Semaglutide placebo 1.0 mg once-weekly
11158764|NCT01930188|EG003|Reported Event|Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg|Sitagliptin 100 mg once-daily + Semaglutide placebo 0.5 mg once-weekly
11158765|NCT01930214|BG000|Baseline|None/Mild Calcification|"Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158766|NCT01930214|BG001|Baseline|Moderate Calcification|"Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158767|NCT01930214|BG002|Baseline|Severe Calcification|"Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158768|NCT01930214|BG003|Baseline|Total|Total of all reporting groups
11158769|NCT01930214|FG000|Participant Flow|None/Mild Calcification|"Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158770|NCT01930214|FG001|Participant Flow|Moderate Calcification|"Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158771|NCT01930214|FG002|Participant Flow|Severe Calcification|"Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158772|NCT01930214|OG000|Outcome|None/Mild Calcification|"Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158773|NCT01930214|OG001|Outcome|Moderate Calcification|"Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158774|NCT01930214|OG002|Outcome|Severe Calcification|"Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158775|NCT01930214|EG000|Reported Event|None/Mild Calcification|"• Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158776|NCT01930214|EG001|Reported Event|Moderate Calcification|"• Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158777|NCT01930214|EG002|Reported Event|Severe Calcification|"• Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion.~Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS)."
11158778|NCT01930435|BG000|Baseline|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
11158779|NCT01930435|FG000|Participant Flow|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
11158780|NCT01930435|OG000|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
11158781|NCT01930435|OG000|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device: This is a personal humidification device. It is hand held and produces sterile warm vapor."
11158782|NCT01930435|EG000|Reported Event|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
11158783|NCT01930487|BG000|Baseline|Participants Completing Study|Participants who completed both arms of the crossover study
11158784|NCT01930487|FG000|Participant Flow|Supplement With Antioxidants, Then Placebo|dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period
11158785|NCT01930487|FG001|Participant Flow|Placebo, Then Supplement With Antioxidants|placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period
11158786|NCT01930487|OG000|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
11158787|NCT01930487|OG001|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
11158788|NCT01930487|EG000|Reported Event|Supplement w/ Antioxidants|"dietary supplement with antioxidants~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
11158789|NCT01930487|EG001|Reported Event|Placebo|"placebo supplement~Placebo: Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants"
11158790|NCT01930643|BG000|Baseline|Electric Muscle Stimulation(EMS)|"EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.~EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day."
11158791|NCT01930643|BG001|Baseline|Control|Patients with routine passive rehabilitation program.
11158792|NCT01930643|BG002|Baseline|Total|Total of all reporting groups
11233881|NCT02431455|BG000|Baseline|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
11158793|NCT01930643|FG000|Participant Flow|Electric Muscle Stimulation(EMS)|"EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.~EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day."
11158794|NCT01930643|FG001|Participant Flow|Control|Patients with routine passive rehabilitation program.
11158795|NCT01930643|OG000|Outcome|Electric Muscle Stimulation(EMS)|"EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.~EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day."
11158796|NCT01930643|OG001|Outcome|Control|Patients with routine passive rehabilitation program.
11158797|NCT01930643|EG000|Reported Event|Electric Muscle Stimulation(EMS)|"EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.~EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day."
11158798|NCT01930643|EG001|Reported Event|Control|Patients with routine passive rehabilitation program.
11158799|NCT01930747|BG000|Baseline|Deep Neuromuscular Block|"deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given~rocuronium: measure effect on laparoscopic workspace"
11158800|NCT01930747|BG001|Baseline|Inhalation With 1 MAC Sevoflurane|"1 MAC Sevoflurane inhalation is given after first measurement of lap workspace~Sevoflurane: 1 MAC sevoflurane inhalation is given"
11158801|NCT01930747|BG002|Baseline|Remifentanyl|"remifentanyl infusion is given after first measurement of lap workspace~remifentanyl: remifentanyl is given in infusion"
11158802|NCT01930747|BG003|Baseline|Total|Total of all reporting groups
11158803|NCT01930747|FG000|Participant Flow|Deep Neuromuscular Block|"deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given~rocuronium: measure effect on laparoscopic workspace"
11158804|NCT01930747|FG001|Participant Flow|Inhalation With 1 MAC Sevoflurane|"1 MAC Sevoflurane inhalation is given after first measurement of lap workspace~Sevoflurane: 1 MAC sevoflurane inhalation is given"
11158805|NCT01930747|FG002|Participant Flow|Remifentanyl|"remifentanyl infusion is given after first measurement of lap workspace~remifentanyl: remifentanyl is given in infusion"
11349176|NCT04115358|OG000|Outcome|Hyaluronic Acid|"Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar~Hyaluronic acid: Gengigel teething: applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material."
11158806|NCT01930747|OG000|Outcome|Deep Neuromuscular Block|"deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given~rocuronium: measure effect on laparoscopic workspace"
11158807|NCT01930747|OG001|Outcome|Inhalation With 1 MAC Sevoflurane|"1 MAC Sevoflurane inhalation is given after first measurement of lap workspace~Sevoflurane: 1 MAC sevoflurane inhalation is given"
11158808|NCT01930747|OG002|Outcome|Remifentanyl|"remifentanyl infusion is given after first measurement of lap workspace~remifentanyl: remifentanyl is given in infusion"
11158809|NCT01930747|EG000|Reported Event|Deep Neuromuscular Block|"deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given~rocuronium: measure effect on laparoscopic workspace"
11158810|NCT01930747|EG001|Reported Event|Inhalation With 1 MAC Sevoflurane|"1 MAC Sevoflurane inhalation is given after first measurement of lap workspace~Sevoflurane: 1 MAC sevoflurane inhalation is given"
11158811|NCT01930747|EG002|Reported Event|Remifentanyl|"remifentanyl infusion is given after first measurement of lap workspace~remifentanyl: remifentanyl is given in infusion"
11158812|NCT01930799|BG000|Baseline|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
11158813|NCT01930799|FG000|Participant Flow|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
11158814|NCT01930799|OG000|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
11158815|NCT01930799|EG000|Reported Event|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
11158816|NCT01930890|BG000|Baseline|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158817|NCT01930890|BG001|Baseline|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158818|NCT01930890|BG002|Baseline|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158819|NCT01930890|BG003|Baseline|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158820|NCT01930890|BG004|Baseline|Total|Total of all reporting groups
11158821|NCT01930890|FG000|Participant Flow|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus mycophenolate mofetil (MMF) and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg intavenously (IV) Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158822|NCT01930890|FG001|Participant Flow|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158823|NCT01930890|FG002|Participant Flow|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158824|NCT01930890|FG003|Participant Flow|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158825|NCT01930890|OG000|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158826|NCT01930890|OG001|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158827|NCT01930890|OG002|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158828|NCT01930890|OG003|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158829|NCT01930890|EG000|Reported Event|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158830|NCT01930890|EG001|Reported Event|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158831|NCT01930890|EG002|Reported Event|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158832|NCT01930890|EG003|Reported Event|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
11158833|NCT01931059|BG000|Baseline|Risperidone Then Placebo|"This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.~Risperidone"
11158834|NCT01931059|BG001|Baseline|Placebo Then Risperidone|"This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day~Risperidone"
11158835|NCT01931059|BG002|Baseline|Total|Total of all reporting groups
11158836|NCT01931059|FG000|Participant Flow|Risperidone Then Placebo|This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day, on third day they did not receive anything.
11158837|NCT01931059|FG001|Participant Flow|Placebo Then Risperidone|This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day, on the third day they did not receive anything.
11158838|NCT01931059|OG000|Outcome|Risperidone Then Placebo|"This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.~Risperidone"
11158839|NCT01931059|OG001|Outcome|Placebo Then Risperidone|"This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day~Risperidone"
11158840|NCT01931059|OG000|Outcome|Risperidone Then Placebo|"This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.~Risperidone: We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.~Placebo: We gave oral liquid without active risperidone (pt and provider were both double blinded)"
11158841|NCT01931059|OG001|Outcome|Placebo Then Risperidone|"This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day~Risperidone: We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.~Placebo: We gave oral liquid without active risperidone (pt and provider were both double blinded)"
11158842|NCT01931059|OG000|Outcome|ON - PUNISHMENT|Subject's performance during the peak of the risperidone effect in the punishment part of the task
11158843|NCT01931059|OG001|Outcome|OFF - PUNISHMENT|Subject's performance after placebo administration.
11158844|NCT01931059|OG002|Outcome|ON - REWARD|Subject's performance during the peak of the risperidone effect in the reward part of the task
11158845|NCT01931059|OG003|Outcome|OFF - REWARD|Subject's performance after placebo administration in the reward part of the task
11158846|NCT01931059|EG000|Reported Event|Risperidone Then Placebo|"This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.~Risperidone"
11158847|NCT01931059|EG001|Reported Event|Placebo Then Risperidone|"This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day~Risperidone"
11158848|NCT01931150|BG000|Baseline|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
11158849|NCT01931150|BG001|Baseline|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
11158850|NCT01931150|BG002|Baseline|Total|Total of all reporting groups
11158851|NCT01931150|FG000|Participant Flow|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
11158852|NCT01931150|FG001|Participant Flow|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
11158853|NCT01931150|OG000|Outcome|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
11158854|NCT01931150|OG001|Outcome|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
11158855|NCT01931150|EG000|Reported Event|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
11158856|NCT01931150|EG001|Reported Event|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
11158857|NCT01931163|BG000|Baseline|Everolimus Plus Cisplatin|Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
11158858|NCT01931163|FG000|Participant Flow|Everolimus Plus Cisplatin|Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
11158859|NCT01931163|OG000|Outcome|Everolimus Plus Cisplatin|Everolimus 10mg by mouth daily for 12 weeks; Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles
11158860|NCT01931163|EG000|Reported Event|Everolimus Plus Cisplatin|Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
11158861|NCT01931202|BG000|Baseline|Placebo|"Blinded treatment with placebo.~Placebo oral tablet: Inert substance or treatment which is designed to have no therapeutic value but resemble the active medication in this study"
11158862|NCT01931202|BG001|Baseline|Escitalopram|"Blinded treatment with either escitalopram, increased to escitalopram 20mg or placebo at week 4 if depression has not remitted~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158863|NCT01931202|BG002|Baseline|Open Treatment With Escitalopram|"Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158864|NCT01931202|BG003|Baseline|Total|Total of all reporting groups
11158865|NCT01931202|FG000|Participant Flow|Double Blind-Placebo Group|Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.
11158866|NCT01931202|FG001|Participant Flow|Double Blind-Escitalopram Group|"Blinded treatment with escitalopram 10mg increased to escitalopram 20mg or placebo at week 4 if depression has not remitted~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158867|NCT01931202|FG002|Participant Flow|Open Treatment With Escitalopram|"Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158868|NCT01931202|OG000|Outcome|Double Blind-Placebo Group|Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.
11158869|NCT01931202|OG001|Outcome|Double Blind-Escitalopram Group|"Blinded treatment with escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158870|NCT01931202|OG002|Outcome|Open Treatment With Escitalopram|"Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158871|NCT01931202|OG001|Outcome|Double Blind-Escitalopram Group|"Blinded treatment with escitalopram 10mg , increased to escitalopram 20mg at week 4 if depression has not remitted~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158872|NCT01931202|OG001|Outcome|Double Blind-Escitalopram Group|"Blinded treatment with either escitalopram 10mg , increased to escitalopram 20mg at week 4 if depression has not remitted~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11233882|NCT02431455|BG001|Baseline|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
11233883|NCT02431455|BG002|Baseline|Total|Total of all reporting groups
10887765|NCT00502593|EG004|Reported Event|GSK1562902A-B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11158873|NCT01931202|OG001|Outcome|Double Blind-Escitalopram Group|"Blinded treatment with either escitalopram 10mg o increased to escitalopram 20mg at week 4 if depression has not remitted~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158874|NCT01931202|EG000|Reported Event|Double Blind-Placebo Group|Blinded treatment with placebo, 1 pill a day for 4 weeks. At week 4, if patients have not remitted, they were increased to 2 pills a day.
11158875|NCT01931202|EG001|Reported Event|Double Blind-Escitalopram Group|"Blinded treatment with either escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158876|NCT01931202|EG002|Reported Event|Open Treatment With Escitalopram|"Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.~Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age."
11158877|NCT01931397|BG000|Baseline|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
11158878|NCT01931397|FG000|Participant Flow|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
11158879|NCT01931397|OG000|Outcome|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
11158880|NCT01931397|OG000|Outcome|At Time of Enrollment|Number of families at enrollment
11158881|NCT01931397|OG001|Outcome|At End of Study|Numbers of families at end of study
11158882|NCT01931397|OG000|Outcome|Group 1|Participants 12 years and over
11158883|NCT01931397|OG001|Outcome|Group 2|Participants less than 12 years of age
11158884|NCT01931397|EG000|Reported Event|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
11158885|NCT01931462|BG000|Baseline|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
11158886|NCT01931462|FG000|Participant Flow|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
11158887|NCT01931462|OG000|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
11158888|NCT01931462|EG000|Reported Event|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
11158889|NCT01931475|BG000|Baseline|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
11158890|NCT01931475|BG001|Baseline|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
11158891|NCT01931475|BG002|Baseline|Total|Total of all reporting groups
11158892|NCT01931475|FG000|Participant Flow|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
11158893|NCT01931475|FG001|Participant Flow|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment.1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
11173915|NCT02018887|BG007|Baseline|Part C: Cohort 8|Part C Multiple Dose, Single Dose Level: Cohort 8A received either placebo or up to 40 LY2969822 BID, PO, for 14 days. (Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, and 40 mg BID for 8 days.) Cohort 8B received either placebo or up to 20 mg LY2969822 BID, PO, for 14 days. (Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, and 20 mg BID for 10 days.)
11158894|NCT01931475|OG000|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
11158895|NCT01931475|OG001|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
11158896|NCT01931475|OG000|Outcome|All Participants (60 mg Duloxetine & Placebo)|"Duloxetine:~Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg.~Placebo:~Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase:~1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment."
11158897|NCT01931475|EG000|Reported Event|60 mg Duloxetine Double Blind|60 mg duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
11158898|NCT01931475|EG001|Reported Event|Placebo Double Blind|Placebo administered by mouth once a day (QD) for 13 weeks.
11158899|NCT01931475|EG002|Reported Event|60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks.
11158900|NCT01931475|EG003|Reported Event|Placebo/60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
11158901|NCT01931475|EG004|Reported Event|60 mg Duloxetine Taper|1-week taper - participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
11158902|NCT01931475|EG005|Reported Event|Placebo Taper|Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
11158903|NCT01931527|BG000|Baseline|Low Uric Acid|16 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid <5mg/dL
11158904|NCT01931527|BG001|Baseline|High Uric Acid|15 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid >6mg/dL
11158905|NCT01931527|BG002|Baseline|Total|Total of all reporting groups
11158906|NCT01931527|FG000|Participant Flow|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
11158907|NCT01931527|FG001|Participant Flow|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
11158908|NCT01931527|OG000|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m^2 with normal uric acid (= or < 5 mg/dL)
11158909|NCT01931527|OG001|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m^2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
11158910|NCT01931527|OG000|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
11158911|NCT01931527|OG001|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
11158912|NCT01931527|OG000|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m² with normal uric acid (= or < 5 mg/dL)
11158913|NCT01931527|OG001|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m² with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
11158914|NCT01931527|EG000|Reported Event|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
11158915|NCT01931527|EG001|Reported Event|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
11158916|NCT01931566|BG000|Baseline|Low Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.
11158917|NCT01931566|BG001|Baseline|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158918|NCT01931566|BG002|Baseline|High Risk Pioglitazone|Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158919|NCT01931566|BG003|Baseline|Total|Total of all reporting groups
11158920|NCT01931566|FG000|Participant Flow|Low Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.
11158921|NCT01931566|FG001|Participant Flow|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158922|NCT01931566|FG002|Participant Flow|High Risk Pioglitazone|Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158923|NCT01931566|OG000|Outcome|Low Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.
11158924|NCT01931566|OG001|Outcome|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158925|NCT01931566|OG000|Outcome|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158926|NCT01931566|OG001|Outcome|High Risk Pioglitazone|Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158927|NCT01931566|EG000|Reported Event|Low Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.
11158928|NCT01931566|EG001|Reported Event|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158929|NCT01931566|EG002|Reported Event|High Risk Pioglitazone|Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.
11158930|NCT01931670|BG000|Baseline|Placebo|Placebo BID for the 6-month Treatment Period
11158931|NCT01931670|BG001|Baseline|Elagolix 150 mg QD|Elagolix 150 mg QD for the 6-month Treatment Period
11158932|NCT01931670|BG002|Baseline|Elagolix 200 mg BID|Elagolix 200 mg BID for the 6-month Treatment Period
11158933|NCT01931670|BG003|Baseline|Total|Total of all reporting groups
11158934|NCT01931670|FG000|Participant Flow|Placebo|Placebo twice daily (BID) for the 6-month Treatment Period
11158935|NCT01931670|FG001|Participant Flow|Elagolix 150 mg QD|Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
11158936|NCT01931670|FG002|Participant Flow|Elagolix 200 mg BID|Elagolix 200 mg BID for the 6-month Treatment Period
11158937|NCT01931670|OG000|Outcome|Placebo|Placebo BID for the 6-month Treatment Period
11158938|NCT01931670|OG001|Outcome|Elagolix 150 mg QD|Elagolix 150 mg QD for the 6-month Treatment Period
11158939|NCT01931670|OG002|Outcome|Elagolix 200 mg BID|Elagolix 200 mg BID for the 6-month Treatment Period
11158940|NCT01931670|EG000|Reported Event|Placebo|Placebo BID for the 6-month Treatment Period
11158941|NCT01931670|EG001|Reported Event|Elagolix 150 mg QD|Elagolix 150 mg QD for the 6-month Treatment Period
11158942|NCT01931670|EG002|Reported Event|Elagolix 200 mg BID|Elagolix 200 mg BID for the 6-month Treatment Period
11158943|NCT01931735|BG000|Baseline|Randomized Meniscectomy|"This group will have a partial meniscectomy~Meniscectomy: Arthroscopic meniscectomy"
11158944|NCT01931735|BG001|Baseline|Randomized Lavage|"This group will have arthroscopy and lavage~Arthroscopic Lavage: Arthroscopic Lavage"
11158945|NCT01931735|BG002|Baseline|Standard of Care Meniscectomy Pre-Amendment|Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
11158946|NCT01931735|BG003|Baseline|Standard of Care Meniscectomy Post Amendment|Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
11158947|NCT01931735|BG004|Baseline|Total|Total of all reporting groups
11158948|NCT01931735|FG000|Participant Flow|Randomized Meniscectomy|"This group will have a partial meniscectomy~Meniscectomy: Arthroscopic meniscectomy"
11158949|NCT01931735|FG001|Participant Flow|Randomized Lavage|"This group will have arthroscopy and lavage~Arthroscopic Lavage: Arthroscopic Lavage"
11158950|NCT01931735|FG002|Participant Flow|Standard of Care Meniscectomy Pre-Amendment|Pre-Amendment: surgeons determined standard of care option best benefited the patient.
11158951|NCT01931735|FG003|Participant Flow|Standard of Care Meniscectomy Post Amendment|Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
11158952|NCT01931735|OG000|Outcome|Randomized Meniscectomy|"This group will have a partial meniscectomy~Meniscectomy: Arthroscopic meniscectomy"
11158953|NCT01931735|OG001|Outcome|Randomized Lavage|"This group will have arthroscopy and lavage~Arthroscopic Lavage: Arthroscopic Lavage"
11158954|NCT01931735|OG002|Outcome|Standard of Care Meniscectomy Pre-Amendment|Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
11158955|NCT01931735|OG003|Outcome|Standard of Care Meniscectomy Post Amendment|Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
11158956|NCT01931735|EG000|Reported Event|Randomized Meniscectomy|"This group will have a partial meniscectomy~Meniscectomy: Arthroscopic meniscectomy"
11158957|NCT01931735|EG001|Reported Event|Randomized Lavage|"This group will have arthroscopy and lavage~Arthroscopic Lavage: Arthroscopic Lavage"
11158958|NCT01931735|EG002|Reported Event|Standard of Care Meniscectomy Pre-Amendment|Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
11158959|NCT01931735|EG003|Reported Event|Standard of Care Meniscectomy Post Amendment|Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
11158960|NCT01931839|BG000|Baseline|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
11158961|NCT01931839|BG001|Baseline|q12h Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
11173916|NCT02018887|BG008|Baseline|Total|Total of all reporting groups
11158962|NCT01931839|BG002|Baseline|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
11158963|NCT01931839|BG003|Baseline|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
11158964|NCT01931839|BG004|Baseline|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
11158965|NCT01931839|BG005|Baseline|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
11158966|NCT01931839|BG006|Baseline|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
11158967|NCT01931839|BG007|Baseline|Total|Total of all reporting groups
11158968|NCT01931839|FG000|Participant Flow|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
11158969|NCT01931839|FG001|Participant Flow|Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
11158970|NCT01931839|FG002|Participant Flow|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
11158971|NCT01931839|FG003|Participant Flow|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
11158972|NCT01931839|FG004|Participant Flow|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
11158973|NCT01931839|FG005|Participant Flow|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
11158974|NCT01931839|FG006|Participant Flow|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
11158975|NCT01931839|OG000|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
11158976|NCT01931839|OG001|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
11158977|NCT01931839|OG002|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
11158978|NCT01931839|OG003|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
11158979|NCT01931839|OG000|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
11158980|NCT01931839|OG001|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
11158981|NCT01931839|OG000|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
11158982|NCT01931839|OG002|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
11158983|NCT01931839|OG000|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211).
11158984|NCT01931839|OG001|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211).
11158985|NCT01931839|OG000|Outcome|Arm 5: Part A Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening or LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening or placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), were observed (did not receive study drug) in this study VX12-809-105 (NCT01931839) for up to 2 years.
11158986|NCT01931839|EG000|Reported Event|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
11158987|NCT01931839|EG001|Reported Event|Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
11158988|NCT01931839|EG002|Reported Event|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
11158989|NCT01931839|EG003|Reported Event|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
11158990|NCT01931839|EG004|Reported Event|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
11158991|NCT01931839|EG005|Reported Event|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
11158992|NCT01931839|EG006|Reported Event|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
11158993|NCT01931865|BG000|Baseline|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
11158994|NCT01931865|FG000|Participant Flow|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
11158995|NCT01931865|OG000|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
11158996|NCT01931865|OG000|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The ttoal dose will not exceed 100 units.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
11158997|NCT01931865|EG000|Reported Event|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
11233884|NCT02431455|FG000|Participant Flow|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
11158998|NCT01931878|BG000|Baseline|All Study Participants|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
11158999|NCT01931878|FG000|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug.
11159000|NCT01931878|FG001|Participant Flow|IncobotulinumtoxinA First, Then Placebo|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo."
11159001|NCT01931878|OG000|Outcome|Placebo|In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections.
11159002|NCT01931878|OG001|Outcome|Xeomin|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
11159003|NCT01931878|OG000|Outcome|Placebo|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo."
11159004|NCT01931878|OG001|Outcome|Xeomin|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions."
11159005|NCT01931878|OG000|Outcome|Placebo , Saline|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design.
11159006|NCT01931878|OG001|Outcome|IncobotulinumtoxinA Treatment|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
11159007|NCT01931878|EG000|Reported Event|Placebo , Saline|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
11159008|NCT01931878|EG001|Reported Event|IncobotulinumtoxinA Treatment|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
11159009|NCT01931956|BG000|Baseline|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159010|NCT01931956|BG001|Baseline|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159011|NCT01931956|BG002|Baseline|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159012|NCT01931956|BG003|Baseline|Non-high Risk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM.~The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant."
11159013|NCT01931956|BG004|Baseline|Total|Total of all reporting groups
11159014|NCT01931956|FG000|Participant Flow|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159015|NCT01931956|FG001|Participant Flow|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159016|NCT01931956|FG002|Participant Flow|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159017|NCT01931956|FG003|Participant Flow|Non-high Risk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM.~The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant"
11159018|NCT01931956|OG000|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159019|NCT01931956|OG001|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159020|NCT01931956|OG002|Outcome|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159021|NCT01931956|OG003|Outcome|Non-high RIsk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant."
11159022|NCT01931956|OG002|Outcome|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.
11159023|NCT01931956|OG003|Outcome|Non-high Risk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant."
11159024|NCT01931956|OG002|Outcome|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant
10887766|NCT00502593|EG005|Reported Event|Fluarix-B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11159025|NCT01931956|OG002|Outcome|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159026|NCT01931956|OG003|Outcome|Non-high Risk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM.~The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implants."
11159027|NCT01931956|OG003|Outcome|Non-high Risk|Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the nonhigh risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159028|NCT01931956|OG002|Outcome|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant
11159029|NCT01931956|OG003|Outcome|Non-high Risk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant"
11159030|NCT01931956|OG000|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant
11159031|NCT01931956|OG001|Outcome|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159032|NCT01931956|OG002|Outcome|Non-high Risk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant."
11159033|NCT01931956|OG000|Outcome|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159034|NCT01931956|OG001|Outcome|Non-high Risk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant."
11159035|NCT01931956|EG000|Reported Event|Compassionate Use|"Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.~MitraClip® implant: Percutaneous mitral valve repair using MitraClip implant"
11159036|NCT01931956|EG001|Reported Event|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159037|NCT01931956|EG002|Reported Event|High Risk|Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
11159038|NCT01931956|EG003|Reported Event|Non-high Risk|"Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).~If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant."
11159039|NCT01931995|BG000|Baseline|TMS to Positively Correlated DLPFC|"High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex~TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression."
11159040|NCT01931995|BG001|Baseline|TMS to Negatively Correlated DLPFC|"High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex~TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression."
11159041|NCT01931995|BG002|Baseline|Total|Total of all reporting groups
11159042|NCT01931995|FG000|Participant Flow|TMS to Positively Correlated DLPFC|"Subjects first received High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex~TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.~Following this, there was a washout period of at least 6 days, after which they received TMS to negatively correlated DLPFC."
11159043|NCT01931995|FG001|Participant Flow|TMS to Negatively Correlated DLPFC|"Subjects first received high frequency TMS to a target region of dorsolateral prefrontal cortex which is negatively correlated with the subgenual cingulate cortex~TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.~After a washout period of at least 6 days they received stimulation with the other treatment (TMS to positively correlated DLPFC)."
11159044|NCT01931995|OG000|Outcome|TMS to Positively Correlated DLPFC|"High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex~TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression."
11159045|NCT01931995|OG001|Outcome|TMS to Negatively Correlated DLPFC|"High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex~TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression."
11159046|NCT01931995|EG000|Reported Event|TMS to Positively Correlated DLPFC|"High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex~TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression."
11159047|NCT01931995|EG001|Reported Event|TMS to Negatively Correlated DLPFC|"High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex~TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression."
11159048|NCT01932060|BG000|Baseline|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
11159049|NCT01932060|BG001|Baseline|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
11159050|NCT01932060|BG002|Baseline|Total|Total of all reporting groups
11159051|NCT01932060|FG000|Participant Flow|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
11159052|NCT01932060|FG001|Participant Flow|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
11159053|NCT01932060|OG000|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
11159054|NCT01932060|OG001|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
11159055|NCT01932060|EG000|Reported Event|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
11159056|NCT01932060|EG001|Reported Event|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
11159057|NCT01932112|BG000|Baseline|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
11159058|NCT01932112|FG000|Participant Flow|Adenosine Arm|"After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
11159059|NCT01932112|OG000|Outcome|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 12mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
11159060|NCT01932112|EG000|Reported Event|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
11159061|NCT01932164|BG000|Baseline|Cleft Lip and Palate|"5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery~maxillary alveolar graft by tissue engineering: Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;~Bone tissue engineering using mesenchymal stem cells: Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
11159062|NCT01932164|FG000|Participant Flow|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
11159063|NCT01932164|OG000|Outcome|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
11159064|NCT01932164|EG000|Reported Event|Cleft Lip and Palate|"5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
11159065|NCT01932242|BG000|Baseline|Sequence A|"16 mg/kg ETI-204 IV on Days 1 and 14 and Placebo on Day 120~ETI-204: Monoclonal Antibody~Placebo: Placebo for ETI-204"
11159066|NCT01932242|BG001|Baseline|Sequence B|"16 mg/kg ETI-204 IV on Days 1 and 120 and Placebo on Day 14~ETI-204: Monoclonal Antibody~Placebo: Placebo for ETI-204"
11159067|NCT01932242|BG002|Baseline|Total|Total of all reporting groups
11159068|NCT01932242|FG000|Participant Flow|Sequence A|"16 mg/kg ETI-204 IV on Days 1 and 14 and Placebo on Day 120~ETI-204: Monoclonal Antibody~Placebo: Placebo for ETI-204"
11159069|NCT01932242|FG001|Participant Flow|Sequence B|"16 mg/kg ETI-204 IV on Days 1 and 120 and Placebo on Day 14~ETI-204: Monoclonal Antibody~Placebo: Placebo for ETI-204"
11159070|NCT01932242|OG000|Outcome|Sequence A|ETI-204 on Days 1 and 14 and placebo on Day 120
11159071|NCT01932242|OG001|Outcome|Sequence B|ETI-204 on Days 1 and 120 and placebo on Day 14
11159072|NCT01932242|EG000|Reported Event|Sequence A|ETI-204 on Days 1 and 14 and placebo on Day 120
11159073|NCT01932242|EG001|Reported Event|Sequence B|ETI-204 on Days 1 and 120 and placebo on Day 14
11159074|NCT01932294|BG000|Baseline|MedaMACS Participants|All participants who have met the inclusion criteria.
11159075|NCT01932294|FG000|Participant Flow|MedaMACS Participants|All participants who have met the inclusion criteria.
11159076|NCT01932294|OG000|Outcome|MedaMACS Participants|All participants who have met the inclusion criteria. By the end of the follow-up, 43 out of 171 patients died.
11159077|NCT01932294|OG000|Outcome|MedaMACS Participants|All participants who have met the inclusion criteria.
11159078|NCT01932294|EG000|Reported Event|MedaMACS Participants|All participants who have met the inclusion criteria.
11159079|NCT01932437|BG000|Baseline|Placebo|"IM~Placebo: Placebo comparator"
11159080|NCT01932437|BG001|Baseline|ETI-204|"IM~ETI-204: monoclonal antibody"
11159081|NCT01932437|BG002|Baseline|Total|Total of all reporting groups
11159082|NCT01932437|FG000|Participant Flow|Placebo|Participants received a single intravenous dose of placebo on day 1 followed by a 71 day follow-up.
11159083|NCT01932437|FG001|Participant Flow|ETI-204 4 mg/kg|Participants received a single intravenous dose of ETI-204 4 mg/kg on day 1with a 71-day follow-up period.
11159084|NCT01932437|FG002|Participant Flow|ETI-204 8 mg/kg|Participants received a single intravenous dose of ETI-204 8 mg/kg on day 1 with a 71 day follow-up period.
11159085|NCT01932437|FG003|Participant Flow|ETI-204 16 mg/kg|Participant received a single intravenous dose of ETI-204 16 mg/kg on day 1 with a 71 day follow-up period.
11159086|NCT01932437|FG004|Participant Flow|ETI-204 20 mg/kg|Participants received a single intravenous dose of ETI-204 20 mg/kg on day 1 with a 71 day follow-up period.
11159087|NCT01932437|FG005|Participant Flow|ETI-204 24 mg/kg|Participants received a single intravenous dose of ETI-204 24 mg/kg on day 1 with a 71 day follow-up period.
11159088|NCT01932437|OG000|Outcome|Placebo|ETI-204 placebo IM
11159089|NCT01932437|OG001|Outcome|Cohort 1|4 mg/kg ETI-204 IM
11159090|NCT01932437|OG002|Outcome|Cohort 2|8 mg/kg ETI-204 IM
11159091|NCT01932437|OG003|Outcome|Cohort 3|16 mg/kg ETI-204 IM
11159092|NCT01932437|OG004|Outcome|Cohort 4|20 mg/kg ETI-204 IM
11159093|NCT01932437|OG005|Outcome|Cohort 5|24 mg/kg ETI-203 IM
11159094|NCT01932437|OG000|Outcome|Cohort 1|4 mg/kg ETI-204 IM
11159095|NCT01932437|OG001|Outcome|Cohort 2|8 mg/kg ETI-204 IM
11159096|NCT01932437|OG002|Outcome|Cohort 3|16 mg/kg ETI-204 IM
11159097|NCT01932437|OG003|Outcome|Cohort 4|20 mg/kg ETI-204 IM
11159098|NCT01932437|OG004|Outcome|Cohort 5|24 mg/kg ETI-204 IM
11159099|NCT01932437|OG000|Outcome|Placebo|ETI-204 Placebo IM
11159100|NCT01932437|OG005|Outcome|Cohort 5|24 mg/kg ETI-204 IM
11159101|NCT01932437|EG000|Reported Event|Placebo|ETI-204 Placebo IM
11159102|NCT01932437|EG001|Reported Event|Cohort 1|4 mg/kg ETI-204 IM
11159103|NCT01932437|EG002|Reported Event|Cohort 2|8 mg ETI-204 IM
11159104|NCT01932437|EG003|Reported Event|Cohort 3|16 mg/kg ETI-204 IM
11159105|NCT01932437|EG004|Reported Event|Cohort 4|20 mg/kg ETI-204 IM
11159106|NCT01932437|EG005|Reported Event|Cohort 5|24 mg/kg ETI-204 IM
11159107|NCT01932606|BG000|Baseline|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
11159108|NCT01932606|BG001|Baseline|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
11159109|NCT01932606|BG002|Baseline|Total|Total of all reporting groups
11159110|NCT01932606|FG000|Participant Flow|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
11159111|NCT01932606|FG001|Participant Flow|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
11159112|NCT01932606|OG000|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
11159113|NCT01932606|OG001|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
11159114|NCT01932606|EG000|Reported Event|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
11159115|NCT01932606|EG001|Reported Event|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
11159116|NCT01932697|BG000|Baseline|Cohort A (Intermediate Risk)|Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
11159117|NCT01932697|BG001|Baseline|Cohort B (Extranodal Extension)|Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
11159118|NCT01932697|BG002|Baseline|Total|Total of all reporting groups
11159119|NCT01932697|FG000|Participant Flow|Cohort A (Intermediate Risk)|Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
11159120|NCT01932697|FG001|Participant Flow|Cohort B (Extranodal Extension)|Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
11159121|NCT01932697|OG000|Outcome|Cohort A (Intermediate Risk)|Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
11159122|NCT01932697|OG001|Outcome|Cohort B (Extranodal Extension)|Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
11159123|NCT01932697|OG002|Outcome|Overall (Cohort A + Cohort B)|Patients in Cohort A and Cohort B
11159124|NCT01932697|OG000|Outcome|Overall (Cohort A + Cohort B)|Patients in Cohort A and Cohort B
11159125|NCT01932697|EG000|Reported Event|Cohort A (Intermediate Risk)|Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
11159126|NCT01932697|EG001|Reported Event|Cohort B (Extranodal Extension)|Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
11159127|NCT01932762|BG000|Baseline|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
11159128|NCT01932762|BG001|Baseline|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
11159129|NCT01932762|BG002|Baseline|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
11159130|NCT01932762|BG003|Baseline|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
11159131|NCT01932762|BG004|Baseline|Total|Total of all reporting groups
11159132|NCT01932762|FG000|Participant Flow|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.
11159133|NCT01932762|FG001|Participant Flow|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
11159134|NCT01932762|FG002|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
11159135|NCT01932762|FG003|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
11159136|NCT01932762|OG000|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
11159137|NCT01932762|OG001|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
11159138|NCT01932762|OG002|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
11159139|NCT01932762|OG003|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
11159140|NCT01932762|EG000|Reported Event|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
11159141|NCT01932762|EG001|Reported Event|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
11159142|NCT01932762|EG002|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
11159143|NCT01932762|EG003|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
11159144|NCT01932788|BG000|Baseline|Vitamin D 4000 IU|"Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.~Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy."
11159145|NCT01932788|BG001|Baseline|Placebo Gummy Vitamin|"Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)~Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy."
11159146|NCT01932788|BG002|Baseline|Total|Total of all reporting groups
11159147|NCT01932788|FG000|Participant Flow|Vitamin D 4000 IU|"Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.~Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy."
11159148|NCT01932788|FG001|Participant Flow|Placebo Gummy Vitamin|"Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)~Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy."
11159149|NCT01932788|OG000|Outcome|Vitamin D 4000 IU|"Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.~Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy."
11159150|NCT01932788|OG001|Outcome|Placebo Gummy Vitamin|"Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)~Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy."
11159151|NCT01932788|EG000|Reported Event|Vitamin D 4000 IU|"Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.~Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy."
11159152|NCT01932788|EG001|Reported Event|Placebo Gummy Vitamin|"Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)~Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy."
11159153|NCT01932970|BG000|Baseline|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
11159154|NCT01932970|FG000|Participant Flow|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
11159155|NCT01932970|OG000|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
11159156|NCT01932970|EG000|Reported Event|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
11159157|NCT01932996|BG000|Baseline|Integrated Intensive Smoking + Alcohol|"IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.~nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge~Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months"
11159158|NCT01932996|BG001|Baseline|Usual Care|"UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines~nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge"
11159159|NCT01932996|BG002|Baseline|Total|Total of all reporting groups
11159160|NCT01932996|FG000|Participant Flow|Integrated Intensive Smoking + Alcohol|"IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.~nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge~Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months"
11159161|NCT01932996|FG001|Participant Flow|Usual Care|"UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines~nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge"
11159162|NCT01932996|OG000|Outcome|Integrated Intensive Smoking + Alcohol|"IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.~nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge~Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months"
11159163|NCT01932996|OG001|Outcome|Usual Care|"UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines~nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge"
11159164|NCT01932996|EG000|Reported Event|Integrated Intensive Smoking + Alcohol|"IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.~nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge~Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months"
11159165|NCT01932996|EG001|Reported Event|Usual Care|"UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines~nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge"
11159166|NCT01933048|BG000|Baseline|Healthcare Worker Administration|FluMist administered by a Healthcare Worker
11159167|NCT01933048|BG001|Baseline|Self-Administration|FluMist self-administered by subject
11159168|NCT01933048|BG002|Baseline|Total|Total of all reporting groups
11159169|NCT01933048|FG000|Participant Flow|Healthcare Worker Administration (HCWA)|FluMist administered by a Healthcare Worker
11159170|NCT01933048|FG001|Participant Flow|Self-Administration (SA)|FluMist self-administered by subject
11159171|NCT01933048|OG000|Outcome|Healthcare Worker Administration|FluMist administered by a Healthcare Worker
11159172|NCT01933048|OG001|Outcome|Self-Administration|FluMist self-administered by subject
11159173|NCT01933048|OG000|Outcome|Healthcare Worker Administration (HCWA)|"FluMist administered by a Healthcare Worker~FluMist: FluMist Intranasal Vaccine~Health care worker-administered (HCWA; n=523)"
11159174|NCT01933048|OG001|Outcome|Self-Administration (SA)|"FluMist self-administered by subject~FluMist: FluMist Intranasal Vaccine~Self-administered (SA)/singleton (n=178), SA/groups of 5 (n=163), and SA/groups of 10 (n=160)."
11159175|NCT01933048|OG000|Outcome|Self-Administration (SA)|"FluMist self-administered by subject~FluMist: FluMist Intranasal Vaccine~Self-administered (SA)/singleton (n=178), SA/groups of 5 (n=163), and SA/groups of 10 (n=160)."
11159176|NCT01933048|EG000|Reported Event|Healthcare Worker Administration|This group includes healthcare worker administration of FluMist to subjects.
11159177|NCT01933048|EG001|Reported Event|Self-Administration|This group includes subjects who self-administered FluMist.
11159178|NCT01933113|BG000|Baseline|Single Arm|"DBS of the LHA~Deep Brain Stimulation of the Lateral Hypothalamic Area"
11159179|NCT01933113|FG000|Participant Flow|Single Arm|"DBS of the LHA~Deep Brain Stimulation of the Lateral Hypothalamic Area"
11159180|NCT01933113|OG000|Outcome|Single Arm|"DBS of the LHA~Deep Brain Stimulation of the Lateral Hypothalamic Area"
11159181|NCT01933113|EG000|Reported Event|Single Arm|Deep Brain Stimulation (DBS) of the Lateral Hypothalamic Area (LHA)
11159182|NCT01933217|BG000|Baseline|Methylphenidate, Then Placebo|"For the first week, participants received the low-dose Methylphenidate condition (Concerta® over-encapsulated). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4. At the end of week 4, participants crossed-over and repeated the same procedures for the placebo condition. No wash-out period was used.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11233885|NCT02431455|FG001|Participant Flow|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
11159183|NCT01933217|BG001|Baseline|Placebo, Then Methylphenidate|"For the first week, participants received the low-dose Placebo condition (white powder pills). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4. At the end of week 4, participants crossed-over and repeated the same procedures for the Methlyphenidate condition. No wash-out period was used.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159184|NCT01933217|BG002|Baseline|Total|Total of all reporting groups
11159185|NCT01933217|FG000|Participant Flow|Methylphenidate, Then Placebo|"For the first week, participants received the low-dose Methylphenidate condition (Concerta® over-encapsulated). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4. At the end of week 4, participants crossed-over and repeated the same procedures for the placebo condition. No wash-out period was used.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159186|NCT01933217|FG001|Participant Flow|Placebo, Then Methlyphenidate|"For the first week, participants received the low-dose Placebo condition (white powder pills). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4. At the end of week 4, participants crossed-over and repeated the same procedures for the Methlyphenidate condition. No wash-out period was used.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159187|NCT01933217|OG000|Outcome|Methylphenidate|"For the first week, participants received the low-dose Methylphenidate condition (Concerta® over-encapsulated). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159188|NCT01933217|OG001|Outcome|Placebo|"For the first week, participants received the low-dose Placebo condition (white powder pills). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159189|NCT01933217|OG000|Outcome|Methylphenidate, Then Placebo|"For the first week, participants received the low-dose Methylphenidate condition (Concerta® over-encapsulated). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4. At the end of week 4, participants crossed-over and repeated the same procedures for the placebo condition. No wash-out period was used.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159190|NCT01933217|OG001|Outcome|Placebo, Then Methlyphenidate|"For the first week, participants received the low-dose Placebo condition (white powder pills). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4. At the end of week 4, participants crossed-over and repeated the same procedures for the Methlyphenidate condition. No wash-out period was used.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159191|NCT01933217|EG000|Reported Event|Methylphenidate|"For the first week, participants received the low-dose Methylphenidate condition (Concerta® over-encapsulated). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159192|NCT01933217|EG001|Reported Event|Placebo|"For the first week, participants received the low-dose Placebo condition (white powder pills). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4.~The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial."
11159193|NCT01933230|BG000|Baseline|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~We will place an Excel Cryo Cooling System collar around your neck for two hours. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~2 hour neck cooling period"
11233886|NCT02431455|OG000|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
11159194|NCT01933230|FG000|Participant Flow|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~Excel Cryo Cooling System: We will place an Excel Cryo Cooling System collar around your neck for two hours."
11159195|NCT01933230|OG000|Outcome|Excel Cryo Cooling System Collar|We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
11159196|NCT01933230|EG000|Reported Event|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~2 hour neck cooling period"
11159197|NCT01933243|BG000|Baseline|PUFA|Participants randomized to omega-3 PUFA
11159198|NCT01933243|BG001|Baseline|Placebo|Participants randomized to placebo
11159199|NCT01933243|BG002|Baseline|Total|Total of all reporting groups
11159200|NCT01933243|FG000|Participant Flow|PUFA|"Fish oil for 12 weeks~Fish oil: Participants will take 4 capsules daily"
11159201|NCT01933243|FG001|Participant Flow|Placebo Pill|"Placebo pills for 12 weeks~Placebo pill: Participants will take 4 capsules daily"
11159202|NCT01933243|OG000|Outcome|PUFA|Participants randomized to omega-3 PUFA
11159203|NCT01933243|OG001|Outcome|Placebo|Participants randomized to placebo
11159204|NCT01933243|EG000|Reported Event|PUFA|Participants randomized to omega-3 PUFA
11159205|NCT01933243|EG001|Reported Event|Placebo|Participants randomized to placebo
11159206|NCT01933334|BG000|Baseline|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
11159207|NCT01933334|BG001|Baseline|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
11159208|NCT01933334|BG002|Baseline|Total|Total of all reporting groups
11159209|NCT01933334|FG000|Participant Flow|Pirfenidone: 2-Week Titration Group|Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day [mg/day]) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
11159210|NCT01933334|FG001|Participant Flow|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
11159211|NCT01933334|OG000|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
11159212|NCT01933334|OG001|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
11159213|NCT01933334|EG000|Reported Event|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
11159214|NCT01933334|EG001|Reported Event|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
11159215|NCT01933399|BG000|Baseline|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
11159216|NCT01933399|BG001|Baseline|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
11159217|NCT01933399|BG002|Baseline|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
11159218|NCT01933399|BG003|Baseline|Total|Total of all reporting groups
11159219|NCT01933399|FG000|Participant Flow|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
11159220|NCT01933399|FG001|Participant Flow|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
11159221|NCT01933399|FG002|Participant Flow|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
11159222|NCT01933399|OG000|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
11159223|NCT01933399|OG001|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
11159224|NCT01933399|OG002|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
11159225|NCT01933399|EG000|Reported Event|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
11159226|NCT01933399|EG001|Reported Event|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
11159227|NCT01933399|EG002|Reported Event|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
11159228|NCT01933425|BG000|Baseline|Patient Characteristics in 14 Women|
11159229|NCT01933425|FG000|Participant Flow|Deep Neuromuscular Block First Then no Neuromuscular Block|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.~Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade~rocuronium~sugammadex~placebo"
11159230|NCT01933425|FG001|Participant Flow|No Neuromuscular Block First Then Deep Neuromuscular Block|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.~Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.~rocuronium~sugammadex~placebo"
11159231|NCT01933425|OG000|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
11159232|NCT01933425|OG001|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
11159233|NCT01933425|OG000|Outcome|Deep Neuromuscular Blockade|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.~Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade~rocuronium~sugammadex~placebo"
11159234|NCT01933425|OG001|Outcome|no Neuromuscular Blockade|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.~Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.~rocuronium~sugammadex~placebo"
11159235|NCT01933425|EG000|Reported Event|Deep Neuromuscular Block First Then no Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
11159236|NCT01933425|EG001|Reported Event|No Neuromuscular Block First Then Deep Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
11159237|NCT01933464|BG000|Baseline|Cromolyn|"Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.~Cromolyn Sodium"
11159238|NCT01933464|BG001|Baseline|Vehicle|"Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.~Normal Saline"
11159239|NCT01933464|BG002|Baseline|Total|Total of all reporting groups
11159240|NCT01933464|FG000|Participant Flow|Cromolyn|"Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.~Cromolyn Sodium"
11159241|NCT01933464|FG001|Participant Flow|Vehicle|"Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.~Normal Saline"
11159242|NCT01933464|OG000|Outcome|Cromolyn|"Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.~Cromolyn Sodium"
11159243|NCT01933464|OG001|Outcome|Vehicle|"Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.~Normal Saline"
11159244|NCT01933464|EG000|Reported Event|Cromolyn|"Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.~Cromolyn Sodium"
11159245|NCT01933464|EG001|Reported Event|Vehicle|"Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.~Normal Saline"
11159246|NCT01933594|BG000|Baseline|Cohort 1-Arm 1A (Romidepsin)|Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159247|NCT01933594|BG001|Baseline|Cohort 2-Arm 2A (Romidepsin)|Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159248|NCT01933594|BG002|Baseline|Cohort 3-Arm 3A (Romidepsin)|Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159249|NCT01933594|BG003|Baseline|Cohorts 1-3 (Placebo for Romidepsin)|Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159250|NCT01933594|BG004|Baseline|Cohort 4-Arm 4A (Romidepsin)|Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159251|NCT01933594|BG005|Baseline|Cohort 4-Arm 4B (Placebo for Romidepsin)|Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159252|NCT01933594|BG006|Baseline|Total|Total of all reporting groups
11159253|NCT01933594|FG000|Participant Flow|Cohort 1-Arm 1A (Romidepsin)|Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159254|NCT01933594|FG001|Participant Flow|Cohort 2-Arm 2A (Romidepsin)|Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159255|NCT01933594|FG002|Participant Flow|Cohort 3-Arm 3A (Romidepsin)|Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159256|NCT01933594|FG003|Participant Flow|Cohorts 1-3 (Placebo for Romidepsin)|Participants in Cohorts 1-3, received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159257|NCT01933594|FG004|Participant Flow|Cohort 4-Arm 4A (Romidepsin)|Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159258|NCT01933594|FG005|Participant Flow|Cohort 4-Arm 4B (Placebo for Romidepsin)|Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159259|NCT01933594|OG000|Outcome|Cohorts 1-3 (Romidepsin)|Participants in Cohorts 1-3 received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159260|NCT01933594|OG000|Outcome|Cohort 4-Arm 4A (Romidepsin)|Participants in Cohort 4 received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159261|NCT01933594|OG000|Outcome|Cohorts 1-3 (Romidepsin)|Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159262|NCT01933594|OG001|Outcome|Cohorts 1-3 (Placebo for Romidepsin)|Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159263|NCT01933594|OG000|Outcome|Cohort 4-Arm 4A (Romidepsin)|Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159264|NCT01933594|OG001|Outcome|Cohort 4-Arm 4B (Placebo for Romidepsin)|Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159265|NCT01933594|OG000|Outcome|Cohort 1-Arm 1A (Romidepsin)|Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159266|NCT01933594|OG001|Outcome|Cohort 2-Arm 2A (Romidepsin)|Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159267|NCT01933594|OG002|Outcome|Cohort 3-Arm 3A (Romidepsin)|Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159268|NCT01933594|OG003|Outcome|Cohorts 1-3 (Placebo for Romidepsin)|Participants in Cohorts 1-3, received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159269|NCT01933594|EG000|Reported Event|Cohort 1-Arm 1A (Romidepsin)|Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159270|NCT01933594|EG001|Reported Event|Cohort 2-Arm 2A (Romidepsin)|Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159271|NCT01933594|EG002|Reported Event|Cohort 3-Arm 3A (Romidepsin)|Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159272|NCT01933594|EG003|Reported Event|Cohorts 1-3 (Placebo for Romidepsin)|Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
11159273|NCT01933594|EG004|Reported Event|Cohort 4-Arm 4A (Romidepsin)|Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159274|NCT01933594|EG005|Reported Event|Cohort 4-Arm 4B (Placebo for Romidepsin)|Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
11159275|NCT01933672|BG000|Baseline|All*|A total of 90 participants with T2DM were consented for this study; of these, 43 transitioned into run-in with Sponsor-provided metformin and a total of 33 participants were randomized.
11159276|NCT01933672|FG000|Participant Flow|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 milligram (mg) immediate-release tablets.
11159277|NCT01933672|FG001|Participant Flow|PF-04937319 150+100mg Then PF-04937319 300mg Then Sitagliptin|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
11159278|NCT01933672|FG002|Participant Flow|PF-04937319 150+100mg Then Sitagliptin Then PF-04937319 300mg|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
11159279|NCT01933672|FG003|Participant Flow|PF-04937319 300mg Then PF-04937319 150+100mg Then Sitagliptin|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days.
11159280|NCT01933672|FG004|Participant Flow|PF-04937319 300mg Then Sitagliptin Then PF-04937319 150+100mg|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period.
11159281|NCT01933672|FG005|Participant Flow|Sitagliptin Then PF-04937319 150+100mg Then PF-04937319 300mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
11159282|NCT01933672|FG006|Participant Flow|Sitagliptin Then PF-04937319 300mg Then PF-04937319 150+100mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the third intervention period.
11159283|NCT01933672|OG000|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11233887|NCT02431455|OG001|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
10887767|NCT00502593|EG006|Reported Event|GSK1562902A-B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11159284|NCT01933672|OG001|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11159285|NCT01933672|OG002|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11159286|NCT01933672|OG000|Outcome|Metformin Run-in|Participants were instructed to take the morning dose of the study medication and at least 1 dose of open label metformin at the same time of day with the morning meal each day.
11159287|NCT01933672|OG001|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11159288|NCT01933672|OG002|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11159289|NCT01933672|OG003|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11159290|NCT01933672|EG000|Reported Event|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 mg immediate-release tablets.
11159291|NCT01933672|EG001|Reported Event|PF-04937319 150+100 mg (Split Dose)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11159292|NCT01933672|EG002|Reported Event|PF-04937319 300 mg (Once Daily)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11159293|NCT01933672|EG003|Reported Event|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
11159294|NCT01933776|BG000|Baseline|ADACEL™ Vaccine Group 1|Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
11159295|NCT01933776|BG001|Baseline|ADACEL™ Vaccine Group 2|Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
11159296|NCT01933776|BG002|Baseline|Total|Total of all reporting groups
11159297|NCT01933776|FG000|Participant Flow|ADACEL™ Vaccine Group 1 (Adults)|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
11159298|NCT01933776|FG001|Participant Flow|ADACEL™ Vaccine Group 2 (Children)|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
11159299|NCT01933776|OG000|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
11159300|NCT01933776|OG001|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
11159301|NCT01933776|EG000|Reported Event|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
11159302|NCT01933776|EG001|Reported Event|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
11159303|NCT01933789|BG000|Baseline|Clinician Intervention|"Received Jumpstart feedback forms and education"
11159304|NCT01933789|BG001|Baseline|Clinician Control|Received/Provided usual care, surveys only
11159305|NCT01933789|BG002|Baseline|IP Team Intervention|"Received Jumpstart feedback forms and education"
11159306|NCT01933789|BG003|Baseline|IP Team Control|Received/Provided usual care, surveys only
11159307|NCT01933789|BG004|Baseline|Patient Intervention|"Received Jumpstart feedback forms and education"
11159308|NCT01933789|BG005|Baseline|Patient Control|Received usual care, surveys only
11159309|NCT01933789|BG006|Baseline|Family Member Intervention|"Received Jumpstart feedback forms and education"
11159310|NCT01933789|BG007|Baseline|Family Member Control|Received usual care, surveys only
11159311|NCT01933789|BG008|Baseline|Interviewees|Key informants: Clinicians, Patients and Family Members. These subjects did not complete baseline measures.
11159312|NCT01933789|BG009|Baseline|Total|Total of all reporting groups
11159313|NCT01933789|FG000|Participant Flow|Clinician Intervention|"Received Jumpstart feedback forms and education"
11159314|NCT01933789|FG001|Participant Flow|Clinician Control|Received/Provided usual care, surveys only
11159315|NCT01933789|FG002|Participant Flow|IP Team Intervention|"Received Jumpstart feedback forms and education"
11159316|NCT01933789|FG003|Participant Flow|IP Team Control|Received/Provided usual care, surveys only
11159317|NCT01933789|FG004|Participant Flow|Patient Intervention|"Received Jumpstart feedback forms and education"
11159318|NCT01933789|FG005|Participant Flow|Patient Control|Received usual care, surveys only
11159319|NCT01933789|FG006|Participant Flow|Family Member Intervention|"Received Jumpstart feedback forms and education"
11159320|NCT01933789|FG007|Participant Flow|Family Member Control|Received usual care, surveys only
11159321|NCT01933789|FG008|Participant Flow|Interviewees|Key informants: Clinicians, Patients and Family Members
11159322|NCT01933789|OG000|Outcome|Clinician Intervention|"Received Jumpstart feedback forms and education"
11159323|NCT01933789|OG001|Outcome|Clinician Control|Received/Provided usual care, surveys only
11159324|NCT01933789|OG002|Outcome|IP Team Intervention|"Received Jumpstart feedback forms and education"
11159325|NCT01933789|OG003|Outcome|IP Team Control|Received/Provided usual care, surveys only
11159326|NCT01933789|OG004|Outcome|Patient Intervention|"Received Jumpstart feedback forms and education"
11159327|NCT01933789|OG005|Outcome|Patient Control|Received usual care, surveys only
11159328|NCT01933789|OG006|Outcome|Family Member Intervention|"Received Jumpstart feedback forms and education"
11159329|NCT01933789|OG007|Outcome|Family Member Control|Received usual care, surveys only
11159330|NCT01933789|OG008|Outcome|Interviewees|Key informants: Clinicians, Patients and Family Members
11159331|NCT01933789|EG000|Reported Event|Clinician Intervention|"Received Jumpstart feedback forms and education"
11159332|NCT01933789|EG001|Reported Event|Clinician Control|Received/Provided usual care, surveys only
11159333|NCT01933789|EG002|Reported Event|IP Team Intervention|"Received Jumpstart feedback forms and education"
11159334|NCT01933789|EG003|Reported Event|IP Team Control|Received/Provided usual care, surveys only
11159335|NCT01933789|EG004|Reported Event|Patient Intervention|"Received Jumpstart feedback forms and education"
11159336|NCT01933789|EG005|Reported Event|Patient Control|Received usual care, surveys only
11159337|NCT01933789|EG006|Reported Event|Family Member Intervention|"Received Jumpstart feedback forms and education"
11159338|NCT01933789|EG007|Reported Event|Family Member Control|Received usual care, surveys only
11159339|NCT01933789|EG008|Reported Event|Interviewees|Key informants: Clinicians, Patients and Family Members
11159340|NCT01933880|BG000|Baseline|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
11159341|NCT01933880|BG001|Baseline|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
11159342|NCT01933880|BG002|Baseline|Total|Total of all reporting groups
11159343|NCT01933880|FG000|Participant Flow|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
11159344|NCT01933880|FG001|Participant Flow|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
11159345|NCT01933880|OG000|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
11159346|NCT01933880|OG001|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
11159347|NCT01933880|OG001|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
11159348|NCT01933880|OG000|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
11159349|NCT01933880|OG001|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
11159350|NCT01933880|OG002|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
11159351|NCT01933880|OG002|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
11159352|NCT01933880|OG001|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d).
11233888|NCT02431455|EG000|Reported Event|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
11159353|NCT01933880|EG000|Reported Event|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
11159354|NCT01933919|BG000|Baseline|Fluvoxamine|"In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.~In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week."
11159355|NCT01933919|BG001|Baseline|Placebo|"In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.~In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week."
11159356|NCT01933919|BG002|Baseline|Total|Total of all reporting groups
11159357|NCT01933919|FG000|Participant Flow|Fluvoxamine|"In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.~In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week."
11159358|NCT01933919|FG001|Participant Flow|Placebo|"In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.~In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week."
11159359|NCT01933919|OG000|Outcome|Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
11159360|NCT01933919|OG001|Outcome|Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
11159361|NCT01933919|OG000|Outcome|Fluvoxamine - Ages 6-11|In the double-blind placebo-controlled phase participants aged 6 to 11 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
11159362|NCT01933919|OG001|Outcome|Placebo - Ages 6-11|In the double-blind placebo-controlled phase participants aged 6 to 11 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
11233889|NCT02431455|EG001|Reported Event|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
10887768|NCT00502593|EG007|Reported Event|Fluarix-B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11159363|NCT01933919|OG002|Outcome|Fluvoxamine - Ages 12-18|In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
11159364|NCT01933919|OG003|Outcome|Placebo - Ages 12-18|In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
11159365|NCT01933919|OG000|Outcome|Fluvoxamine - Males|In the double-blind placebo-controlled phase male participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
11159366|NCT01933919|OG001|Outcome|Placebo - Males|In the double-blind placebo-controlled phase male participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
11159367|NCT01933919|OG002|Outcome|Fluvoxamine - Females|In the double-blind placebo-controlled phase female participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
11159368|NCT01933919|OG003|Outcome|Placebo - Females|In the double-blind placebo-controlled phase female participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
11159369|NCT01933919|OG000|Outcome|Fluvoxamine/Fluvoxamine|In the open-label long-term phase participants who received fluvoxamine in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
11159370|NCT01933919|OG001|Outcome|Placebo/Fluvoxamine|In the open-label long-term phase participants who received placebo in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
11159371|NCT01933919|EG000|Reported Event|First Phase: Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
11159372|NCT01933919|EG001|Reported Event|First Phase: Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
11159373|NCT01933919|EG002|Reported Event|Second Phase: Fluvoxamine/Fluvoxamine|In the open-label long-term phase participants who received fluvoxamine in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
11159374|NCT01933919|EG003|Reported Event|Second Phase: Placebo/Fluvoxamine|In the open-label long-term phase participants who received placebo in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
11173917|NCT02018887|FG000|Participant Flow|Part A: Cohort 1|"Participants were randomised to receive 2 single, oral doses of LY2969822 and 1 oral dose of placebo over the 3 study periods in a crossover fashion. For each study period, it was intended that 6 subjects would receive LY2969822 and 3 subjects would receive placebo.~Placebo administered once, orally (PO) at all three periods. 2 milligrams (mg) LY2969822 administered once, PO during period 1. 20 mg LY2969822 administered once, PO during period 2. 40 mg LY2969822 administered once, PO during period 3."
11159375|NCT01933984|BG000|Baseline|Individualized Dosing|"Ventilator support~Determining personal target airway resistance~Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent~Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days~Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days~Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met (until ventilator discontinuation or the 28th day if ventilator-dependent)"
11159376|NCT01933984|BG001|Baseline|Fixed Dosing|"Ventilator support~Determining personal target airway resistance~Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent~Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days~Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days~No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met"
11159377|NCT01933984|BG002|Baseline|Total|Total of all reporting groups
11159378|NCT01933984|FG000|Participant Flow|Individualized Dosing|"Ventilator support~Determining personal target airway resistance~Salmeterol/fluticasone 4 puffs inhalation q12h until ventilator discontinuation or the 28th day if ventilator-dependent~Ipatropium/salbutamol 1 vial inhalation q6h for the first 3 days~Methylprednisolone 40 mg intravenous injection q8h for the first 3 days~Additional Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met"
11159379|NCT01933984|FG001|Participant Flow|Fixed Dosing|"Ventilator support~Determining personal target airway resistance~Salmeterol/fluticasone 4 puffs inhalation q12h until ventilator discontinuation or the 28th day if ventilator-dependent~Ipatropium/salbutamol 1 vial inhalation q6h for the first 3 days~Methylprednisolone 40 mg intravenous injection q8h for the first 3 days~No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met"
11159380|NCT01933984|OG000|Outcome|Individualized Dosing|"Ventilator support~Determining personal target airway resistance~Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent~Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days~Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days~Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met (until ventilator discontinuation or the 28th day if ventilator-dependent) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0"
11159381|NCT01933984|OG001|Outcome|Fixed Dosing|"Ventilator support~Determining personal target airway resistance~Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent~Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days~Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days~No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th"
11159382|NCT01933984|OG000|Outcome|Individualized Dosing|"Ventilator support~Determining personal target airway resistance~Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent~Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days~Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days~Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met (until ventilator discontinuation or the 28th day if ventilator-dependent)"
11159383|NCT01933984|OG001|Outcome|Fixed Dosing|"Ventilator support~Determining personal target airway resistance~Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent~Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days~Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days~No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met"
11159384|NCT01933984|OG000|Outcome|Individualized Dosing|"Ventilator support~Determining personal target airway resistance~Salmeterol/fluticasone 4 puffs inhalation q12h until ventilator discontinuation or the 28th day if ventilator-dependent~Ipatropium/salbutamol 1 vial inhalation q6h for the first 3 days~Methylprednisolone 40 mg intravenous injection q8h for the first 3 days~Additional Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met"
11159385|NCT01933984|OG001|Outcome|Fixed Dosing|"Ventilator support~Determining personal target airway resistance~Salmeterol/fluticasone 4 puffs inhalation q12h until ventilator discontinuation or the 28th day if ventilator-dependent~Ipatropium/salbutamol 1 vial inhalation q6h for the first 3 days~Methylprednisolone 40 mg intravenous injection q8h for the first 3 days~No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met"
11173918|NCT02018887|FG001|Participant Flow|Part A: Cohort 2|"Participants were randomised to receive 2 single, oral doses of LY2969822 and 1 oral dose of placebo over the 3 study periods in a crossover fashion. For each study period, it was intended that 6 subjects would receive LY2969822 and 3 subjects would receive placebo.~Placebo administered once, PO at all three periods. 6 mg LY2969822 administered once, PO during period 1. 60 mg LY2969822 administered once, PO during period 2. 20 mg LY2969822 administered once, PO during period 3."
11173919|NCT02018887|FG002|Participant Flow|Cohorts 3-7 - Placebo|Placebo administered once a day (QD) or twice a day (BID), PO, for 14 days.
11159386|NCT01933984|EG000|Reported Event|Individualized Dosing|"Ventilator support~Determining personal target airway resistance~Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent~Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days~Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days~Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met (until ventilator discontinuation or the 28th day if ventilator-dependent) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0"
11159387|NCT01933984|EG001|Reported Event|Fixed Dosing|"Ventilator support~Determining personal target airway resistance~Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent~Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days~Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days~No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th"
11159388|NCT01934010|BG000|Baseline|1 Cycle AM-101|Subjects participated in 1 treatment cycle and received one round of 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0-D4)
11159389|NCT01934010|BG001|Baseline|2 Cycles AM-101|Subjects that participated in 2 treatment cycles of the AMPACT1 study, received 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0 - D4) in cycle 1 and after final follow-up (D84) of cycle 1, they rolled-over to treatment cycle 2 receiving once more 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D84 - D88).
11159390|NCT01934010|BG002|Baseline|3 Cycles AM-101|Subjects that participated in all 3 treatment cycles of the AMPACT1 study, received 3 x 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days. The subjects could only roll-over if they completed the final follow-up of the previous cycle and were still eligible. In cycle 1 treatment was within D0 - D4. Cycle 2 treatment within D84 - D88. And treatment for cycle 3 within D168-D172. Final follow-up after 3 treatment cycles was FUV9 (D252).
11159391|NCT01934010|BG003|Baseline|Total|Total of all reporting groups
11159392|NCT01934010|FG000|Participant Flow|1 Cycle AM-101|Subjects participated in 1 treatment cycle and received one round of 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0-D4)
11159393|NCT01934010|FG001|Participant Flow|2 Cycles AM-101|Subjects that participated in 2 treatment cycles of the AMPACT1 study, received 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0 - D4) in cycle 1 and after final follow-up (D84) of cycle 1, they rolled-over to treatment cycle 2 receiving once more 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D84 - D88).
11159394|NCT01934010|FG002|Participant Flow|3 Cycles AM-101|Subjects that participated in all 3 treatment cycles of the AMPACT1 study, received 3 x 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days. The subjects could only roll-over if they completed the final follow-up of the previous cycle and were still eligible. In cycle 1 treatment was within D0 - D4. Cycle 2 treatment within D84 - D88. And treatment for cycle 3 within D168-D172. Final follow-up after 3 treatment cycles was FUV9 (D252).
11159395|NCT01934010|OG000|Outcome|1 Cycle AM-101|Subjects that participated only in 1 treatment cycle. This endpoint counts existing deteriorations at FUV2.
11159396|NCT01934010|OG001|Outcome|2 Cycles AM-101|Subjects that participated in 2 treatment cycles. This endpoint lists deteriorations at FUV2.
11159397|NCT01934010|OG002|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV2.
11159398|NCT01934010|OG000|Outcome|2 Cycles AM-101|Subjects that participated in 2 treatment cycles. This endpoint lists deteriorations at FUV5.
11159399|NCT01934010|OG001|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV5.
11159400|NCT01934010|OG000|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV8.
10887769|NCT00502593|EG008|Reported Event|GSK1562902A-C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11159401|NCT01934010|OG000|Outcome|1 Cycle AM-101|Subjects that participated only in 1 treatment cycle. This endpoint counts existing deteriorations at FUV3.
11159402|NCT01934010|OG001|Outcome|2 Cycles AM-101|Subjects that participated in 2 treatment cycles. This endpoint lists deteriorations at FUV3.
11159403|NCT01934010|OG002|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV3.
11159404|NCT01934010|OG000|Outcome|2 Cycles AM-101|Subjects that participated in 2 treatment cycles. This endpoint lists deteriorations at FUV6.
11159405|NCT01934010|OG001|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV6.
11159406|NCT01934010|OG000|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV9.
11159407|NCT01934010|EG000|Reported Event|1 Cycle AM-101|Subjects participated in 1 treatment cycle and received one round of 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0-D4)
11159408|NCT01934010|EG001|Reported Event|2 Cycles AM-101|Subjects that participated in 2 treatment cycles of the AMPACT1 study, received 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0 - D4) in cycle 1 and after final follow-up (D84) of cycle 1, they rolled-over to treatment cycle 2 receiving once more 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D84 - D88).
11173920|NCT02018887|FG003|Participant Flow|Cohort 3 - 20 mg LY2969822 QD|20 mg LY2969822 administered QD, PO, for 14 days.
11173921|NCT02018887|FG004|Participant Flow|Cohort 4 - 40 mg LY2969822 QD Titrated|Up to 40 mg LY2969822 administered QD, PO, for 14 days. Titration: 6 mg QD for 3 days, 20 mg QD for 2 days, and 40 mg QD for 9 days.
11159409|NCT01934010|EG002|Reported Event|3 Cycles AM-101|Subjects that participated in all 3 treatment cycles of the AMPACT1 study, received 3 x 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days. The subjects could only roll-over if they completed the final follow-up of the previous cycle and were still eligible. In cycle 1 treatment was within D0 - D4. Cycle 2 treatment within D84 - D88. And treatment for cycle 3 within D168-D172. Final follow-up after 3 treatment cycles was FUV9 (D252).
11159410|NCT01934140|BG000|Baseline|ACWY-TT Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination.
11159411|NCT01934140|BG001|Baseline|MenPS Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
11159412|NCT01934140|BG002|Baseline|Total|Total of all reporting groups
11159413|NCT01934140|FG000|Participant Flow|ACWY-TT Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 millilitre (mL) dose of meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination.
11159414|NCT01934140|FG001|Participant Flow|MenPS Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
11159415|NCT01934140|OG000|Outcome|ACWY-TT Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination.
11159416|NCT01934140|OG001|Outcome|MenPS Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
11159417|NCT01934140|EG000|Reported Event|Persistence Phase: ACWY-TT Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence (of immune response) for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination.
11159418|NCT01934140|EG001|Reported Event|Persistence Phase: MenPS Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence (of immune response) for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
11159419|NCT01934140|EG002|Reported Event|Booster Phase: ACWY-TT Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence (of immune response) for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination.
11173922|NCT02018887|FG005|Participant Flow|Cohort 5 - 80 mg LY2969822 QD Titrated|Up to 80 mg LY2969822 administered QD, PO, for 14 days. Titration: 6 mg QD for 2 days, 20 mg QD for 2 days, 40 mg QD for 2 days and 80 mg QD for 8 days.
11159420|NCT01934140|EG003|Reported Event|Booster Phase: MenPS Group|Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence (of immune response) for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
11159421|NCT01934192|BG000|Baseline|Baseline EN Tolerant: Placebo/Camicinal|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
11159422|NCT01934192|BG001|Baseline|Baseline EN Tolerant: Camicinal/Metoclopramide|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
11159423|NCT01934192|BG002|Baseline|Baseline EN Intolerant: Camicinal|Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
11159424|NCT01934192|BG003|Baseline|Baseline EN Intolerant: Metoclopramide|Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.
11159425|NCT01934192|BG004|Baseline|Total|Total of all reporting groups
11159426|NCT01934192|FG000|Participant Flow|Baseline EN Tolerant: Placebo/Camicinal|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
11159427|NCT01934192|FG001|Participant Flow|Baseline EN Tolerant: Camicinal/Metoclopramide|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
11159428|NCT01934192|FG002|Participant Flow|Baseline EN Intolerant: Camicinal|Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
11159429|NCT01934192|FG003|Participant Flow|Baseline EN Intolerant: Metoclopramide|Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.
11159430|NCT01934192|OG000|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
11159431|NCT01934192|OG001|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
11159432|NCT01934192|OG000|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
11159433|NCT01934192|OG001|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
11159434|NCT01934192|OG002|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
11159435|NCT01934192|OG003|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.
11159436|NCT01934192|OG004|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
11159437|NCT01934192|OG005|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
11159438|NCT01934192|OG003|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
11159439|NCT01934192|OG000|Outcome|Baseline EN Tolerant: Placebo/Camicinal|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
11159440|NCT01934192|OG001|Outcome|Baseline EN Tolerant: Camicinal/Metoclopramide|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
11159441|NCT01934192|OG002|Outcome|Baseline EN Intolerant: Camicinal|Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
11159442|NCT01934192|OG003|Outcome|No Treatment|Participant who did not receive treatment.
11159443|NCT01934192|EG000|Reported Event|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
11159444|NCT01934192|EG001|Reported Event|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
11159445|NCT01934192|EG002|Reported Event|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
11159446|NCT01934192|EG003|Reported Event|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
10887770|NCT00502593|EG009|Reported Event|Fluarix-C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11159447|NCT01934192|EG004|Reported Event|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
11159448|NCT01934192|EG005|Reported Event|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
11159449|NCT01934218|BG000|Baseline|Gel-One|The participants received a single intra-articular injection of Gel-One.
11159450|NCT01934218|BG001|Baseline|Placebo|The participants received a single intra-articular injection of PBS.
11159451|NCT01934218|BG002|Baseline|Total|Total of all reporting groups
11159452|NCT01934218|FG000|Participant Flow|Gel-One|The participants received a single intra-articular injection of Gel-One.
11159453|NCT01934218|FG001|Participant Flow|Placebo|The participants received a single intra-articular injection of Phosphate Buffered Saline (PBS).
11159454|NCT01934218|OG000|Outcome|Gel-One|The participants received a single intra-articular injection of Gel-One.
11159455|NCT01934218|OG001|Outcome|Placebo|The participants received a single intra-articular injection of PBS.
11159456|NCT01934218|EG000|Reported Event|Gel-One|3 mL, a single intra-articular injection of Gel-One.
11159457|NCT01934218|EG001|Reported Event|Placebo|3 mL, a single intra-articular injection of PBS.
11159458|NCT01934231|BG000|Baseline|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
11159459|NCT01934231|FG000|Participant Flow|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
11159460|NCT01934231|OG000|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
11159461|NCT01934231|EG000|Reported Event|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
11159462|NCT01934335|BG000|Baseline|Vandetanib|"Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery~Vandetanib"
11159463|NCT01934335|BG001|Baseline|Placebo|"Placebo, PO, q day for 7-14 days prior to surgery.~Placebo"
11159464|NCT01934335|BG002|Baseline|Total|Total of all reporting groups
11159465|NCT01934335|FG000|Participant Flow|Vandetanib|"Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery~Vandetanib"
11159466|NCT01934335|FG001|Participant Flow|Placebo|"Placebo, PO, q day for 7-14 days prior to surgery.~Placebo"
11159467|NCT01934335|OG000|Outcome|Vandetanib|"Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery~Vandetanib"
11159468|NCT01934335|OG001|Outcome|Placebo|"Placebo, PO, q day for 7-14 days prior to surgery.~Placebo"
11159469|NCT01934335|EG000|Reported Event|Vandetanib|"Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery~Vandetanib"
11159470|NCT01934335|EG001|Reported Event|Placebo|"Placebo, PO, q day for 7-14 days prior to surgery.~Placebo"
11159471|NCT01934517|BG000|Baseline|iTero, Lava Digital and Plaster Models|All study participants: iTero, LavaDigital and plaster models (single-group study)
11159472|NCT01934517|FG000|Participant Flow|iTero, Lava Digital and Plaster Models: All Study Participants|"Single-group study:~ITero models obtained from intraoral scans with iTero scanner~Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster~Lava Digital models obtained from extraoral scans of plaster models"
11159473|NCT01934517|OG000|Outcome|iTero Models|ITero models obtained from intraoral scans with iTero scanner
11159474|NCT01934517|OG001|Outcome|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
11159475|NCT01934517|OG002|Outcome|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
11159476|NCT01934517|EG000|Reported Event|iTero Models|ITero models obtained from intraoral scans with iTero scanner
11159477|NCT01934517|EG001|Reported Event|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
11159478|NCT01934517|EG002|Reported Event|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
11159479|NCT01934556|BG000|Baseline|Monthly|"Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months.~Ranibizumab 0.3 mg intravitreal injection"
11159480|NCT01934556|BG001|Baseline|TREX|"(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.~Ranibizumab 0.3 mg intravitreal injection"
11159481|NCT01934556|BG002|Baseline|GILA|(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.
11159482|NCT01934556|BG003|Baseline|Total|Total of all reporting groups
11159483|NCT01934556|FG000|Participant Flow|Monthly|Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months.
11159484|NCT01934556|FG001|Participant Flow|TREX|(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits and then underwent a treat and extend protocol of ranibizumab without navigated laser therapy.
11159485|NCT01934556|FG002|Participant Flow|GILA|(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits and then underwent a treat and extend protocol of ranibizumab with navigated laser therapy.
11159486|NCT01934556|OG000|Outcome|Monthly|"Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months.~Ranibizumab 0.3 mg intravitreal injection"
11159487|NCT01934556|OG001|Outcome|TREX|"(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.~Ranibizumab 0.3 mg intravitreal injection"
11159488|NCT01934556|OG002|Outcome|GILA|(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.
11159489|NCT01934556|EG000|Reported Event|Monthly|"Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months.~Ranibizumab 0.3 mg intravitreal injection"
11159490|NCT01934556|EG001|Reported Event|TREX|"(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.~Ranibizumab 0.3 mg intravitreal injection"
11173923|NCT02018887|FG006|Participant Flow|Cohort 6 - 80 mg LY2969822 BID Titrated|Up to 80 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.
11173924|NCT02018887|FG007|Participant Flow|Cohort 7 - 40 mg LY2969822 BID Rapidly Titrated|Up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, and 40 mg BID for 12 days.
11173925|NCT02018887|FG008|Participant Flow|Cohort 8 - Placebo BID|Placebo administered BID, PO, for 14 days.
11173926|NCT02018887|FG009|Participant Flow|Cohort 8A - 40 mg LY2969822 BID Titrated|Up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, and 40 mg BID for 8 days.)
11159491|NCT01934556|EG002|Reported Event|GILA|(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.
11159492|NCT01934582|BG000|Baseline|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria, who had sufficient treprostinil concentration-time data to derive noncompartmental PK parameters for at least 1 treatment of open-label treprostinil diethanolamine.
11159493|NCT01934582|FG000|Participant Flow|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria who received at least 1 treatment of open-label treprostinil diethanolamine.
11159494|NCT01934582|OG000|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
11159495|NCT01934582|OG001|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
11159496|NCT01934582|EG000|Reported Event|PK Visit 1|UT-15C SR (treprostinil diethanolamine): open-label study drug
11159497|NCT01934582|EG001|Reported Event|PK Visit 2|UT-15C SR (treprostinil diethanolamine): open-label study drug
11159498|NCT01934790|BG000|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
11159499|NCT01934790|FG000|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
11159500|NCT01934790|OG000|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
11159501|NCT01934790|EG000|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections
11159502|NCT01934894|BG000|Baseline|Dose Level 1 (20 mg/m2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159503|NCT01934894|BG001|Baseline|Dose Level 2 (Level 1 (25 mg/m2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159504|NCT01934894|BG002|Baseline|Total|Total of all reporting groups
11159505|NCT01934894|FG000|Participant Flow|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159506|NCT01934894|FG001|Participant Flow|Dose Level 2 (Level 1 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159507|NCT01934894|OG000|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159508|NCT01934894|OG001|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159509|NCT01934894|OG000|Outcome|Cabazitaxel and Lapatinib|Cabazitaxel: (at Dose Level 1, 20 mg/m^2 or at Dose Level 2, 25 mg/m^2), 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159510|NCT01934894|OG000|Outcome|Dose Level 1|Cabazitaxel: 20 mg/m^2: 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159511|NCT01934894|OG001|Outcome|Dose Level 2|Cabazitaxel 25mg/m^2:: 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159512|NCT01934894|EG000|Reported Event|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159513|NCT01934894|EG001|Reported Event|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
11159514|NCT01934972|BG000|Baseline|CR + DCS|"Subjects will receive Cognitive Remediation and active study drug.~CR + DCS (D-cycloserine): CR + DCS"
11159515|NCT01934972|BG001|Baseline|CR + Placebo|"Cognitive Remediation and placebo~CR + placebo: CR + placebo"
11159516|NCT01934972|BG002|Baseline|Total|Total of all reporting groups
11159517|NCT01934972|FG000|Participant Flow|CR + DCS|"Subjects will receive Cognitive Remediation and active study drug.~CR + DCS (D-cycloserine): CR + DCS"
11159518|NCT01934972|FG001|Participant Flow|CR + Placebo|"Cognitive Remediation and placebo~CR + placebo: CR + placebo"
11159519|NCT01934972|OG000|Outcome|CR + DCS|"Subjects will receive Cognitive Remediation and active study drug.~CR + DCS (D-cycloserine): CR + DCS"
11159520|NCT01934972|OG001|Outcome|CR + Placebo|"Cognitive Remediation and placebo~CR + placebo: CR + placebo"
11159521|NCT01934972|EG000|Reported Event|CR + DCS|"Subjects will receive Cognitive Remediation and active study drug.~CR + DCS (D-cycloserine): CR + DCS"
11159522|NCT01934972|EG001|Reported Event|CR + Placebo|"Cognitive Remediation and placebo~CR + placebo: CR + placebo"
11159523|NCT01935180|BG000|Baseline|Standard Colonoscopy|Standard colonoscopy without an attachment cap
11159524|NCT01935180|BG001|Baseline|Cap Assisted Colonoscopy|"A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.~Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope."
11159525|NCT01935180|BG002|Baseline|Total|Total of all reporting groups
11159526|NCT01935180|FG000|Participant Flow|Standard Colonoscopy|Standard colonoscopy without an attachment cap
11159527|NCT01935180|FG001|Participant Flow|Cap Assisted Colonoscopy|"A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.~Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope."
11159528|NCT01935180|OG000|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
11159529|NCT01935180|OG001|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
11159530|NCT01935180|EG000|Reported Event|Standard Colonoscopy|Colonoscopy without a cap.
11159531|NCT01935180|EG001|Reported Event|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
11159532|NCT01935622|BG000|Baseline|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
11159533|NCT01935622|BG001|Baseline|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
11159534|NCT01935622|BG002|Baseline|Placebo|"Placebo~placebo"
11159535|NCT01935622|BG003|Baseline|Total|Total of all reporting groups
11159536|NCT01935622|FG000|Participant Flow|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
11159537|NCT01935622|FG001|Participant Flow|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
11159538|NCT01935622|FG002|Participant Flow|Placebo|"Placebo~placebo"
11159539|NCT01935622|OG000|Outcome|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
11159540|NCT01935622|OG001|Outcome|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
11159541|NCT01935622|OG002|Outcome|Placebo|"Placebo~placebo"
11159542|NCT01935622|EG000|Reported Event|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
11159543|NCT01935622|EG001|Reported Event|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
11159544|NCT01935622|EG002|Reported Event|Placebo|"Placebo~placebo"
11159545|NCT01935700|BG000|Baseline|Colchicine Treated Patients|This group included participants receiving total daily colchicine dose equal or larger than 1.5 mg for more than 8 cycles (28 days).
11159546|NCT01935700|BG001|Baseline|Sorafenib Treated Group|This group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
11159547|NCT01935700|BG002|Baseline|Total|Total of all reporting groups
11159548|NCT01935700|FG000|Participant Flow|Colchicine Treated Patients|"The dosing schedule started from 1 mg three times per day after meal for 4 days and stopped for the following 3 days (1 cycle). This cycle was repeated till the participant quitted this trial.~Adjustment of colchicine dosage during study:~The colchicine dosage was changed when the hepatic reserved function of the participant changed from Child A to B or C according to the following rules.~Total daily dose reduced to 2.5 mg (1mg morning, 0.5 mg afternoon, 1 mg night) for participant with Child class B.~If the participant changed to Child class C, colchicine will be stopped and participant received regular follow-up only.~Colchicine was temporarily stopped in participant suffered from diarrhea and was started again with reducing daily total dose of 0.5 mg.~Colchicine was temporarily stopped when the participant fitted any of the exclusion criteria during the study, and was given again after the fitted exclusion criterion was eliminated."
11159549|NCT01935700|FG001|Participant Flow|Sorafenib Treated Group|This group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
11159550|NCT01935700|OG000|Outcome|Colchicine Group|Participant received more than 8 courses of colchicine management.
11159551|NCT01935700|OG001|Outcome|Sorafenib Treated Group|The control group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
11159552|NCT01935700|OG000|Outcome|Colchicine Group|This included the events occured after the participant signed the inform consent.
11159553|NCT01935700|OG001|Outcome|Sorafenib Treated Group|This group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
11159554|NCT01935700|EG000|Reported Event|Colchicine Group|"2 tablets (0.5 mg/tablet) of colchicine three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial~Colchicine: Adjustment the dosage of colchicine during study:~The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day."
11159555|NCT01935700|EG001|Reported Event|Sorafenib Treated Group|The control group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
11159556|NCT01935791|BG000|Baseline|All Participants|All participants who were randomised
11159557|NCT01935791|FG000|Participant Flow|Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle|"Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine.~Visit 2 Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of gelofusine without a cooling vest."
11159558|NCT01935791|FG001|Participant Flow|Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon|Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine Visit 2 Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min without a cooling vest.
11159559|NCT01935791|FG002|Participant Flow|Period 1 Visit 1 - Cold PET-CT Vehicle, no Visit 2 as BAT Negative|"Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine.~No brown adipose tissue (BAT) identified on visit 1, therefore no visit 2."
11159560|NCT01935791|FG003|Participant Flow|Period 2 - Visit 1 Warm Control Vehicle, Visit 2 Warm Glucagon, Visit 3 Cold Control|"Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius.~Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius.~Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest."
11159561|NCT01935791|FG004|Participant Flow|Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold Control , Visit 3 Warm Control|"Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius.~Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.~Visit 3 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius."
11159562|NCT01935791|FG005|Participant Flow|Period 2 -Visit 1 Cold Control, Visit 2 Warm Control, Visit 3 Warm Glucagon|"Visit 1 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.~Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius.~Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius."
11159563|NCT01935791|FG006|Participant Flow|Period 2 -Visit 1 Cold Control, Visit 2 Warm Glucagon, Visit 3 Warm Control|"Visit 1 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.~Visit 2- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius.~Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius."
11159564|NCT01935791|FG007|Participant Flow|Period 2- Visit 1 Warm Glucagon, Visit 2 Warm Control, Visit 3 Cold Control|"Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius.~Visit 2 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius.~Visit 3- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest."
11159565|NCT01935791|FG008|Participant Flow|Period 2 -Visit 1 Warm Control, Visit 2 Cold Control, Visit 3 Warm Glucagon|"Visit 1 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius.~Visit 2- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.~Visit 3 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius"
11159566|NCT01935791|OG000|Outcome|Period 1 Cold PET-CT Vehicle|Visit 1. emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine.
11159567|NCT01935791|OG001|Outcome|Period 1 Warm PET-CT Vehicle|Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of gelofusine without a cooling vest.
11159568|NCT01935791|OG002|Outcome|Period 1 Warm PET(CT) Glucagon|Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min without a cooling vest.
11159569|NCT01935791|OG000|Outcome|Period 2 - Cold Control|Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.
11159570|NCT01935791|OG001|Outcome|Period 2 - Warm Control|Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius.
11159571|NCT01935791|OG002|Outcome|Period 2 -Warm Glucagon|Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius.
11159572|NCT01935791|EG000|Reported Event|Period 1 Visit 1 Cold Vehicle|Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine.
11159573|NCT01935791|EG001|Reported Event|Period 1 Visit 2 Warm Glucagon|Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min without a cooling vest.
11159574|NCT01935791|EG002|Reported Event|Period 1 Visit 2 Warm Vehicle|Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of gelofusine without a cooling vest.
11159575|NCT01935791|EG003|Reported Event|Period 2 Cold Control|Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.
11159576|NCT01935791|EG004|Reported Event|Period 2 Warm Control|Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius.
11159577|NCT01935791|EG005|Reported Event|Period 2 Warm Glucagon|Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius.
11159578|NCT01936181|BG000|Baseline|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
11159579|NCT01936181|BG001|Baseline|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
11159580|NCT01936181|BG002|Baseline|Total|Total of all reporting groups
11159581|NCT01936181|FG000|Participant Flow|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
11159582|NCT01936181|FG001|Participant Flow|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
11159583|NCT01936181|FG002|Participant Flow|Remicade (Infliximab), Switch to SB2|"SB2 3mg/kg at week 54, 62, 70~SB2 (proposed biosimilar to infliximab)"
11159584|NCT01936181|FG003|Participant Flow|Remicade (Infliximab), Continue as Remicade|"Remicade 3mg/kg at week 54, 62, 70~Remicade (infliximab)"
11159585|NCT01936181|OG000|Outcome|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
11159586|NCT01936181|OG001|Outcome|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
11159587|NCT01936181|OG000|Outcome|SB2 at Week 54|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
11159588|NCT01936181|OG001|Outcome|Remicade (Infliximab) at Week 54|Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
11159589|NCT01936181|OG002|Outcome|SB2 at Week 78|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
11159590|NCT01936181|OG003|Outcome|Remicade (Infliximab), Switch to SB2 at Week 78|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised to be transitioned to SB2 (Remicade/SB2) up to Week 70 and received SB2 3mg/kg at week 54, 62, 70.~SB2 (proposed biosimilar to infliximab)"
11159591|NCT01936181|OG004|Outcome|Remicade (Infliximab), Continue as Remicade|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised to continue on Remicade (Remicade/Remicade) up to Week 70 and received Remicade 3mg/kg at week 54, 62, 70."
11159592|NCT01936181|EG000|Reported Event|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
11159593|NCT01936181|EG001|Reported Event|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
11159594|NCT01936259|BG000|Baseline|Comprehensive Mini Humeral Stem|This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).
11159595|NCT01936259|BG001|Baseline|Comprehensive Nano Humeral Component|This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
11159596|NCT01936259|BG002|Baseline|Total|Total of all reporting groups
11159597|NCT01936259|FG000|Participant Flow|Comprehensive Mini Humeral Stem|This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).
11159598|NCT01936259|FG001|Participant Flow|Comprehensive Nano Humeral Component|This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
11159599|NCT01936259|OG000|Outcome|Comprehensive Mini Humeral Stem|This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).
11159600|NCT01936259|OG001|Outcome|Comprehensive Nano Humeral Component|This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
11159601|NCT01936259|EG000|Reported Event|Comprehensive Mini Humeral Stem|This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).
11159602|NCT01936259|EG001|Reported Event|Comprehensive Nano Humeral Component|This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
11159603|NCT01936324|BG000|Baseline|Olumacostat Glasaretil Gel, 7.5%, Phase 1|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
11159604|NCT01936324|BG001|Baseline|Olumacostat Glasaretil Gel, 7.5%, Phase 2a|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
11159605|NCT01936324|BG002|Baseline|Olumacostat Glasaretil Gel, Vehicle, Phase 2a|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11159606|NCT01936324|BG003|Baseline|Total|Total of all reporting groups
11159607|NCT01936324|FG000|Participant Flow|Olumacostat Glasaretil Gel, 7.5%, Phase 1|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
11159608|NCT01936324|FG001|Participant Flow|Olumacostat Glasaretil Gel, 7.5%, Phase 2a|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
11159609|NCT01936324|FG002|Participant Flow|Olumacostat Glasaretil Gel, Vehicle, Phase 2a|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11159610|NCT01936324|OG000|Outcome|Olumacostat Glasaretil Gel, 7.5%, Phase 2a|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
11159611|NCT01936324|OG001|Outcome|Olumacostat Glasaretil Gel, Vehicle, Phase 2a|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11159612|NCT01936324|EG000|Reported Event|Olumacostat Glasaretil Gel, 7.5%, Phase 1|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
11159613|NCT01936324|EG001|Reported Event|Olumacostat Glasaretil Gel, 7.5%, Phase 2a|Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
11159614|NCT01936324|EG002|Reported Event|Olumacostat Glasaretil Gel, Vehicle, Phase 2a|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11159615|NCT01936363|BG000|Baseline|Pimasertib (Once Daily) Plus SAR245409|Participants received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
11159616|NCT01936363|BG001|Baseline|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
11159617|NCT01936363|BG002|Baseline|Total|Total of all reporting groups
11159618|NCT01936363|FG000|Participant Flow|Pimasertib (Once Daily) Plus SAR245409|Participants received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
11159619|NCT01936363|FG001|Participant Flow|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
11159620|NCT01936363|OG000|Outcome|Pimasertib (Once Daily) Plus SAR245409|Participants received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
11159621|NCT01936363|OG001|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
11159622|NCT01936363|EG000|Reported Event|Pimasertib (Once Daily) Plus SAR245409|Participants received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
11159623|NCT01936363|EG001|Reported Event|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
11159624|NCT01936389|BG000|Baseline|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
11159625|NCT01936389|BG001|Baseline|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
11159626|NCT01936389|BG002|Baseline|Total|Total of all reporting groups
11159627|NCT01936389|FG000|Participant Flow|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
11159628|NCT01936389|FG001|Participant Flow|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
11159629|NCT01936389|OG000|Outcome|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
11159630|NCT01936389|OG001|Outcome|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
11159631|NCT01936389|EG000|Reported Event|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
11159632|NCT01936389|EG001|Reported Event|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
11159633|NCT01936467|BG000|Baseline|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
11159634|NCT01936467|BG001|Baseline|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
11159635|NCT01936467|BG002|Baseline|Total|Total of all reporting groups
11159636|NCT01936467|FG000|Participant Flow|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
11159637|NCT01936467|FG001|Participant Flow|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
11159638|NCT01936467|OG000|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
11159639|NCT01936467|OG000|Outcome|Standard Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
11159640|NCT01936467|OG000|Outcome|Patients With Positive Gold Standard|gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.
11159641|NCT01936467|OG001|Outcome|Patients With Negative Gold Standard|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
11159642|NCT01936467|OG000|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
11159643|NCT01936467|OG001|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
11159644|NCT01936467|EG000|Reported Event|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
11159645|NCT01936467|EG001|Reported Event|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
11159646|NCT01936519|BG000|Baseline|Calcineurin Inhibitor and Mycophenolic Acid|"Calcineurin inhibitor immunosuppression with mycophenolic acid~Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA)."
11159647|NCT01936519|BG001|Baseline|Everolimus and Mycophenolic Acid|"Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.~Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant."
11159648|NCT01936519|BG002|Baseline|Total|Total of all reporting groups
11159649|NCT01936519|FG000|Participant Flow|Calcineurin Inhibitor and Mycophenolic Acid|"Calcineurin inhibitor immunosuppression with mycophenolic acid~Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA)."
11159650|NCT01936519|FG001|Participant Flow|Everolimus and Mycophenolic Acid|"Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.~Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant."
11159651|NCT01936519|OG000|Outcome|Calcineurin Inhibitor With Mycophenolic Acid|"Calcineurin inhibitor immunosuppression with mycophenolic acid~Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA)."
11159652|NCT01936519|OG001|Outcome|Everolimus With Mycophenolic Acid|"Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.~Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant."
11159653|NCT01936519|OG000|Outcome|Calcineurin Inhibitor and Mycophenolic Acid|"Calcineurin inhibitor immunosuppression with mycophenolic acid~Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA)."
11159654|NCT01936519|OG001|Outcome|Everolimus and Mycophenolic Acid|"Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.~Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant."
11173927|NCT02018887|FG010|Participant Flow|Cohort 8B - 20 mg LY2969822 BID Titrated|Up to 20 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, and 20 mg BID for 10 days.
11173928|NCT02018887|OG000|Outcome|Cohort 1 - Placebo|Placebo administered once, PO.
11159655|NCT01936519|OG001|Outcome|Everolimus and Mycophenolic Acid|"Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.~Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant."
11159656|NCT01936519|EG000|Reported Event|Calcineurin Inhibitor and Mycophenolic Acid|"Calcineurin inhibitor immunosuppression with mycophenolic acid~Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA)."
11159657|NCT01936519|EG001|Reported Event|Everolimus and Mycophenolic Acid|"Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.~Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant."
11159658|NCT01936623|BG000|Baseline|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
11159659|NCT01936623|BG001|Baseline|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
11159660|NCT01936623|BG002|Baseline|Total|Total of all reporting groups
11159661|NCT01936623|FG000|Participant Flow|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
11159662|NCT01936623|FG001|Participant Flow|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
11159663|NCT01936623|OG000|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
11159664|NCT01936623|OG001|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
11159665|NCT01936623|EG000|Reported Event|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
11159666|NCT01936623|EG001|Reported Event|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
11159667|NCT01936649|BG000|Baseline|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
11159668|NCT01936649|FG000|Participant Flow|AdreView (Iobenguane I 123 Injection)|Two administrations of single intravenous (i.v.) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
11159669|NCT01936649|OG000|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
11159670|NCT01936649|EG000|Reported Event|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
11159671|NCT01936662|BG000|Baseline|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
11159672|NCT01936662|BG001|Baseline|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
11159673|NCT01936662|BG002|Baseline|Total|Total of all reporting groups
11159674|NCT01936662|FG000|Participant Flow|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
11159675|NCT01936662|FG001|Participant Flow|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
11159676|NCT01936662|OG000|Outcome|Largyngeal Mask Airway for EGD Procedure|"Patients randomized to LMA to maintain airway through EGD procedure~LMA: Patients randomized to the LMA group had their airways maintained with a LMA device"
11159677|NCT01936662|OG001|Outcome|Endotracheal Tube for EGD Procedure|"Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital~ETT: Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital"
11159678|NCT01936662|OG000|Outcome|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
11159679|NCT01936662|OG001|Outcome|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
11159680|NCT01936662|EG000|Reported Event|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
11159681|NCT01936662|EG001|Reported Event|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
11173929|NCT02018887|OG001|Outcome|Cohort 1 - 2 mg LY2969822|20 mg LY2969822 administered once, PO.
11173930|NCT02018887|OG002|Outcome|Cohort 1 - 20 mg LY2969822|20 mg LY2969822 administered once, PO.
11349177|NCT04115358|EG000|Reported Event|Hyaluronic Acid|"Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar~Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material."
11159682|NCT01936844|BG000|Baseline|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
11159683|NCT01936844|BG001|Baseline|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
11159684|NCT01936844|BG002|Baseline|Total|Total of all reporting groups
11159685|NCT01936844|FG000|Participant Flow|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
11159686|NCT01936844|FG001|Participant Flow|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
11159687|NCT01936844|OG000|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
11159688|NCT01936844|OG001|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
11159689|NCT01936844|EG000|Reported Event|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
11159690|NCT01936844|EG001|Reported Event|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
11159691|NCT01936870|BG000|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
11159692|NCT01936870|FG000|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
11159693|NCT01936870|OG000|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
11159694|NCT01936870|EG000|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
11159695|NCT01936896|BG000|Baseline|Alpha-1 Anti-trypsin (AAT)|Plasma derived (Alpha 1-Antitrypsin) AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
11159696|NCT01936896|FG000|Participant Flow|Alpha-1 Anti-trypsin (AAT)|Plasma derived Alpha 1-Antitrypsin (AAT) 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
11159697|NCT01936896|OG000|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
11159698|NCT01936896|EG000|Reported Event|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
11159699|NCT01936909|BG000|Baseline|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
11159700|NCT01936909|BG001|Baseline|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
11159701|NCT01936909|BG002|Baseline|Placebo|"Placebo injections daily for 12 weeks~Placebo"
11159702|NCT01936909|BG003|Baseline|Total|Total of all reporting groups
11159703|NCT01936909|FG000|Participant Flow|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
11159704|NCT01936909|FG001|Participant Flow|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
11159705|NCT01936909|FG002|Participant Flow|Placebo|"Placebo injections daily for 12 weeks~Placebo"
11159706|NCT01936909|OG000|Outcome|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
11159707|NCT01936909|OG001|Outcome|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
11159708|NCT01936909|OG002|Outcome|Placebo|"Placebo injections daily for 12 weeks~Placebo"
11159709|NCT01936909|EG000|Reported Event|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
11159710|NCT01936909|EG001|Reported Event|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
11159711|NCT01936909|EG002|Reported Event|Placebo|"Placebo injections daily for 12 weeks~Placebo"
11159712|NCT01936948|BG000|Baseline|Clip Closure + EndoCut|"Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.~Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis."
11159713|NCT01936948|BG001|Baseline|Clip Closure + Coagulation|"Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.~Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis."
11159714|NCT01936948|BG002|Baseline|No Clip Closure + EndoCut|No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.
11159715|NCT01936948|BG003|Baseline|No Clip Closure + Coagulation|No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.
11159716|NCT01936948|BG004|Baseline|Total|Total of all reporting groups
11159717|NCT01936948|FG000|Participant Flow|Clip Closure + EndoCut|"Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.~Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis."
11159718|NCT01936948|FG001|Participant Flow|Clip Closure + Coagulation|"Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.~Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis."
11159719|NCT01936948|FG002|Participant Flow|No Clip Closure + EndoCut|No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.
11159720|NCT01936948|FG003|Participant Flow|No Clip Closure + Coagulation|No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.
11159721|NCT01936948|OG000|Outcome|Clip Closure|"Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode.~Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis."
11159722|NCT01936948|OG001|Outcome|No Clip Closure|No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode.
11159723|NCT01936948|EG000|Reported Event|Clip Closure + EndoCut|"Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.~Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis."
11159724|NCT01936948|EG001|Reported Event|Clip Closure + Coagulation|"Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.~Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis."
11159725|NCT01936948|EG002|Reported Event|No Clip Closure + EndoCut|No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.
11159726|NCT01936948|EG003|Reported Event|No Clip Closure + Coagulation|No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.
11159727|NCT01937026|BG000|Baseline|Baricitinib|"4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
11159728|NCT01937026|FG000|Participant Flow|Baricitinib|"4 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, twice daily (BID), on Days 3 through 7 in Period 2."
11159729|NCT01937026|OG000|Outcome|Baricitinib|4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
11159730|NCT01937026|OG001|Outcome|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
11159731|NCT01937026|EG000|Reported Event|Baricitinib|"4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.~Adverse events are reported from baseline through predose on Day 3."
11159732|NCT01937026|EG001|Reported Event|Probenecid|"1000 mg probenecid tablet administered orally, BID, on Days 3 through 4 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 5."
11159733|NCT01937026|EG002|Reported Event|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 5 through 7 in Period 2.~Adverse events are reported from postdose on Day 5 up to Day 18."
11159734|NCT01937117|BG000|Baseline|Trastuzumab and Pertuzumab|"Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)~Positron emission tomography (PET): PET will be performed at baseline and on day 15~Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV~Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV"
11173931|NCT02018887|OG003|Outcome|Cohort 1 - 40 mg LY2969822|40 mg LY2969822 administered once, PO.
11159735|NCT01937117|FG000|Participant Flow|Trastuzumab and Pertuzumab|"Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)~Positron emission tomography (PET): PET will be performed at baseline and on day 15~Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV~Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV"
11159736|NCT01937117|OG000|Outcome|Trastuzumab and Pertuzumab|"Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)~Positron emission tomography (PET): PET will be performed at baseline and on day 15~Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV~Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV"
11159737|NCT01937117|EG000|Reported Event|Trastuzumab and Pertuzumab|"Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)~Positron emission tomography (PET): PET will be performed at baseline and on day 15~Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV~Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV"
11159738|NCT01937130|BG000|Baseline|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
11159739|NCT01937130|BG001|Baseline|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
11159740|NCT01937130|BG002|Baseline|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
11159741|NCT01937130|BG003|Baseline|Placebo|"Dosed twice daily~Placebo"
11159742|NCT01937130|BG004|Baseline|Total|Total of all reporting groups
11159743|NCT01937130|FG000|Participant Flow|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
11159744|NCT01937130|FG001|Participant Flow|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
11159745|NCT01937130|FG002|Participant Flow|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
10887771|NCT00502593|EG010|Reported Event|GSK1562902A-C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11159746|NCT01937130|FG003|Participant Flow|Placebo|"Dosed twice daily~Placebo"
11159747|NCT01937130|OG000|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
11159748|NCT01937130|OG001|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
11159749|NCT01937130|OG002|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
11159750|NCT01937130|OG003|Outcome|Placebo|"Dosed twice daily~Placebo"
11159751|NCT01937130|EG000|Reported Event|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
11159752|NCT01937130|EG001|Reported Event|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
11159753|NCT01937130|EG002|Reported Event|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
11159754|NCT01937130|EG003|Reported Event|Placebo|"Dosed twice daily~Placebo"
11159755|NCT01937195|BG000|Baseline|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
11159756|NCT01937195|FG000|Participant Flow|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
11159757|NCT01937195|OG000|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
11159758|NCT01937195|EG000|Reported Event|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
11159759|NCT01937260|BG000|Baseline|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
11159760|NCT01937260|BG001|Baseline|Cohort 2|Brodalumab 140mg SC (Day1)
11159761|NCT01937260|BG002|Baseline|Total|Total of all reporting groups
11159762|NCT01937260|FG000|Participant Flow|Cohort 1|Midazolam (MDZ) 2mg Oral (Day 1 and Day 9) Brodalumab 210 mg SC (Day 2)
11159763|NCT01937260|FG001|Participant Flow|Cohort 2|Brodalumab 140 mg SC (Day 1)
11159764|NCT01937260|OG000|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
11159765|NCT01937260|OG000|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9)Brodalumab 210mg SC (Day 2)
11159766|NCT01937260|EG000|Reported Event|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
11159767|NCT01937260|EG001|Reported Event|Cohort 2|Brodalumab 140mg SC (Day1)
11159768|NCT01937299|BG000|Baseline|SIMBRINZA|1 drop instilled 3 times a day in each eye for 6 weeks as adjunctive therapy to travoprost ophthalmic solution 0.004%
11159769|NCT01937299|BG001|Baseline|Vehicle|1 drop instilled 3 times a day in each eye for 6 weeks in conjunction with travoprost ophthalmic solution 0.004%
11159770|NCT01937299|BG002|Baseline|Total|Total of all reporting groups
11159771|NCT01937299|FG000|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
11159772|NCT01937299|FG001|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
11159773|NCT01937299|OG000|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
11159774|NCT01937299|OG001|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
11159775|NCT01937299|EG000|Reported Event|Pre-Treatment|Travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 4-week run-in period
11159776|NCT01937299|EG001|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
11159777|NCT01937299|EG002|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
11159778|NCT01937312|BG000|Baseline|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
11159779|NCT01937312|BG001|Baseline|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
11159780|NCT01937312|BG002|Baseline|Total|Total of all reporting groups
11159781|NCT01937312|FG000|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
11159782|NCT01937312|FG001|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
11159783|NCT01937312|OG000|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
11159784|NCT01937312|OG001|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
11159785|NCT01937312|EG000|Reported Event|Pre-Treatment|Prostaglandin analogue, 1 drop in each eye at bedtime for a 4-week run-in period
11159786|NCT01937312|EG001|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
11159787|NCT01937312|EG002|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
11159788|NCT01937351|BG000|Baseline|Primary Cohort|"The Primary Cohort consisted of either the 1st subject enrolled after the Roll-In cohort or the 1st subject enrolled if the site did not utilize Roll-In subjects.~The Primary Cohort was analyzed as two separate sub-cohorts: Intention-to-Treat and Per Protocol. The Intention-to-Treat Cohort includes all subjects that were enrolled. The Per Protocol Cohort includes subjects who were enrolled, and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the Intention-to Treat-Cohort.~The Primary Per Protocol Cohort was the cohort used to determine if the primary endpoints of the VISION Study were met."
11159789|NCT01937351|BG001|Baseline|Roll-In Cohort|The Roll-In Cohort consists of either the 1st subject or 1st and 2nd subjects treated at each site prior to enrollment of subjects into the Primary Cohort. Roll-Ins were designed to provide the Investigator an opportunity to gain experience with the Pantheris System (Catheter and Optical Coherence Tomography-assisted orientation) for learning curve purposes. Certain sites were exempt from enrolling in the Roll-In Cohort.
11159790|NCT01937351|BG002|Baseline|Total|Total of all reporting groups
11159791|NCT01937351|FG000|Participant Flow|Primary Cohort|"The Primary Cohort consisted of either the 1st subject enrolled after the Roll-In cohort or the 1st subject enrolled if the site did not utilize Roll-In subjects.~The Primary Cohort was analyzed as two separate sub-cohorts: Intention-to-Treat and Per Protocol. The Intention-to-Treat Cohort includes all subjects that were enrolled. The Per Protocol Cohort includes subjects who were enrolled, and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the Intention-to-Treat Cohort.~The Primary Per Protocol Cohort was the cohort used to determine if the primary endpoints of the VISION Study were met."
11159792|NCT01937351|FG001|Participant Flow|Roll-in Cohort|Atherectomy with Pantheris System: The Roll-In Cohort consists of either the 1st subject or 1st and 2nd subjects treated at each site prior to enrollment of subjects into the Primary Cohort. Roll-Ins were designed to provide the Investigator an opportunity to gain experience with the Pantheris System (Catheter and Optical Coherence Tomography-assisted orientation) for learning curve purposes. Certain sites were exempt from enrolling in the Roll-In Cohort.
11159793|NCT01937351|OG000|Outcome|Primary Cohort: Per Protocol|The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
11159794|NCT01937351|OG001|Outcome|Primary Cohort: Intention-to-Treat|The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
11159795|NCT01937351|EG000|Reported Event|Primary Cohort|Pantheris System
11159796|NCT01937364|BG000|Baseline|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours
11159797|NCT01937364|BG001|Baseline|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours
11159798|NCT01937364|BG002|Baseline|Total|Total of all reporting groups
11159799|NCT01937364|FG000|Participant Flow|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
11159800|NCT01937364|FG001|Participant Flow|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
11159801|NCT01937364|OG000|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
11159802|NCT01937364|OG001|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
11159803|NCT01937364|EG000|Reported Event|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
11159804|NCT01937364|EG001|Reported Event|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
11173932|NCT02018887|OG004|Outcome|Cohort 2 - Placebo|Placebo administered once, PO.
11173933|NCT02018887|OG005|Outcome|Cohort 2 - 6 mg LY2969822|6 mg LY2969822 administered once, PO.
11159805|NCT01937390|BG000|Baseline|LAMA/LABA Patients|Patients taking once daily oral inhalation of Long-acting bronchodilators (long-acting β2-agonists [LABAs]/ long-acting muscarinic antagonists [LAMAs]) during the study period of 52 weeks.
11159806|NCT01937390|FG000|Participant Flow|LAMA/LABA Patients|Patients taking once daily oral inhalation of Long-acting bronchodilators (long-acting β2-agonists [LABAs]/ long-acting muscarinic antagonists [LAMAs]) during the study period of 52 weeks.
11159807|NCT01937390|OG000|Outcome|LAMA/LABA Patients|Patients taking once daily oral inhalation of Long-acting bronchodilators (long-acting β2-agonists [LABAs]/ long-acting muscarinic antagonists [LAMAs]) during the study period of 52 weeks.
11159808|NCT01937390|EG000|Reported Event|LAMA/LABA Patients|Patients taking once daily oral inhalation of Long-acting bronchodilators (long-acting β2-agonists [LABAs]/ long-acting muscarinic antagonists [LAMAs]) during the study period of 52 weeks.
11159809|NCT01937520|BG000|Baseline|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
11159810|NCT01937520|BG001|Baseline|Sham/Placebo|"no acupuncture will be done on this group of subjects. Since they are under general anesthesia they will not realize they are acting as control group~no acupuncture: placebo"
11159811|NCT01937520|BG002|Baseline|Total|Total of all reporting groups
11159812|NCT01937520|FG000|Participant Flow|Acupuncture|"acupuncture will be administered after anesthesia induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
11159813|NCT01937520|FG001|Participant Flow|Sham|"no acupuncture will be done on this group of subjects but since they will be under general anesthesia they will not be aware that they are the control group~no acupuncture: placebo"
11159814|NCT01937520|OG000|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
11159815|NCT01937520|OG001|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
11159816|NCT01937520|OG001|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
11159817|NCT01937520|EG000|Reported Event|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
11159818|NCT01937520|EG001|Reported Event|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
11159819|NCT01937559|BG000|Baseline|Topical Tranexamic Acid (TXA)|"TXA administered topically~Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically"
11159820|NCT01937559|BG001|Baseline|Saline|Normal saline administered topically
11159821|NCT01937559|BG002|Baseline|Intravenous Tranexamic Acid (TXA)|Current standard of care is Tranexamic acid (TXA) administered intravenously. This arm was added as a retrospective comparative group, thus these patients were not randomized during the original study.
11159822|NCT01937559|BG003|Baseline|Total|Total of all reporting groups
11159823|NCT01937559|FG000|Participant Flow|Topical Tranexamic Acid (TXA)|Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically
11159824|NCT01937559|FG001|Participant Flow|Saline (Control)|Normal saline administered topically (control)
11159825|NCT01937559|FG002|Participant Flow|Intravenous Tranexamic Acid (TXA)|Current standard of care is Tranexamic acid (TXA) administered intravenously. This arm was added as a retrospective comparative group, thus these patients were not randomized during the original study.
11159826|NCT01937559|OG000|Outcome|Topical Tranexamic Acid (TXA)|"Tranexamic acid (TXA) administered topically~Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution"
11159827|NCT01937559|OG001|Outcome|Saline|"Normal saline~Normal saline"
11159828|NCT01937559|OG002|Outcome|Intravenous Tranexamic Acid (TXA)|Tranexamic acid (TXA) administered intravenously
11159829|NCT01937559|OG002|Outcome|Intravenous Tranexamic Acid (TXA)|TXA administered intravenously
11159830|NCT01937559|OG000|Outcome|Topical Tranexamic Acid (TXA)|"Topical Tranexamic acid (TXA)~Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution"
11159831|NCT01937559|OG002|Outcome|Intravenous Tranexamic Acid (TXA)|Intravenous Tranexamic acid (TXA)
11159832|NCT01937559|OG000|Outcome|Topical Tranexamic Acid (TXA)|"Tranexamic acid (TXA)~Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution"
11159833|NCT01937559|EG000|Reported Event|Topical Tranexamic Acid (TXA)|"Topical Tranexamic acid (TXA)~Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution"
11159834|NCT01937559|EG001|Reported Event|Saline|"Normal saline~Normal saline"
11159835|NCT01937559|EG002|Reported Event|Intravenous Tranexamic Acid (TXA)|Intravenous Tranexamic acid (TXA)
11159836|NCT01937598|BG000|Baseline|All Study Participants|All study participants (cross-over design) received all interventions.
11159837|NCT01937598|FG000|Participant Flow|Sitagliptin, Then Placebo|Participants first received Sitagliptin tablet before mixed meal test, after washout they then received Placebo before the mixed meal test.
11159838|NCT01937598|FG001|Participant Flow|Placebo, Than Sitagliptin|Participants first received Placebo tablet before mixed meal test, after washout they then received Sitagliptin before the mixed meal test.
11159839|NCT01937598|OG000|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
11159840|NCT01937598|OG001|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
11159841|NCT01937598|EG000|Reported Event|Sitagliptin|"Substance: Sitagliptin phosphate 1H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
11159842|NCT01937598|EG001|Reported Event|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
11159843|NCT01937624|BG000|Baseline|Diagnostic Ultrasound and Radiographic Imaging|The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.
11159844|NCT01937624|FG000|Participant Flow|Diagnostic Ultrasound and Radiographic Imaging|"The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.~Diagnostic Ultrasound"
11159845|NCT01937624|OG000|Outcome|Diagnostic Ultrasound and Radiographic Imaging|"The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.~Diagnostic Ultrasound"
11159846|NCT01937624|EG000|Reported Event|Diagnostic Ultrasound and Radiographic Imaging|"The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.~Diagnostic Ultrasound"
11159847|NCT01937715|BG000|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
11159848|NCT01937715|BG001|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159849|NCT01937715|BG002|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159850|NCT01937715|BG003|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159851|NCT01937715|BG004|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159852|NCT01937715|BG005|Baseline|Total|Total of all reporting groups
11159853|NCT01937715|FG000|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
11159854|NCT01937715|FG001|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159855|NCT01937715|FG002|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
10887772|NCT00502593|EG011|Reported Event|Fluarix-C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
11159856|NCT01937715|FG003|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159857|NCT01937715|FG004|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159858|NCT01937715|OG000|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
11159859|NCT01937715|OG001|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159860|NCT01937715|OG002|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159861|NCT01937715|OG003|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159862|NCT01937715|OG004|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159863|NCT01937715|EG000|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
11159864|NCT01937715|EG001|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159865|NCT01937715|EG002|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159866|NCT01937715|EG003|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159867|NCT01937715|EG004|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
11159868|NCT01937871|BG000|Baseline|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
11159869|NCT01937871|BG001|Baseline|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
11159870|NCT01937871|BG002|Baseline|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
11159871|NCT01937871|BG003|Baseline|Total|Total of all reporting groups
11159872|NCT01937871|FG000|Participant Flow|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
11159873|NCT01937871|FG001|Participant Flow|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
11159874|NCT01937871|FG002|Participant Flow|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
11159875|NCT01937871|OG000|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
11159876|NCT01937871|OG001|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
11159877|NCT01937871|OG002|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
11159878|NCT01937871|OG001|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
11159879|NCT01937871|OG002|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
11159880|NCT01937871|OG001|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
11159881|NCT01937871|EG000|Reported Event|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
11159882|NCT01937871|EG001|Reported Event|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
11159883|NCT01937871|EG002|Reported Event|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
11159884|NCT01937884|BG000|Baseline|Early Parenteral Nutrition|Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
11159885|NCT01937884|BG001|Baseline|Late Parenteral Nutrition|Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
11159886|NCT01937884|BG002|Baseline|Total|Total of all reporting groups
11159887|NCT01937884|FG000|Participant Flow|Early Parenteral Nutrition|Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
11159888|NCT01937884|FG001|Participant Flow|Late Parenteral Nutrition|Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
11159889|NCT01937884|OG000|Outcome|Early Parenteral Nutrition|"Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.~Parenteral Nutrition"
11159890|NCT01937884|OG001|Outcome|Late Parenteral Nutrition|"Patients receive supplemental parenteral nutrition 96 hours after enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.~Parenteral Nutrition"
11159891|NCT01937884|OG000|Outcome|Early Parenteral Nutrition|Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
11159892|NCT01937884|OG001|Outcome|Late Parenteral Nutrition|Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
11159893|NCT01937884|EG000|Reported Event|Early Parenteral Nutrition|Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
11159894|NCT01937884|EG001|Reported Event|Late Parenteral Nutrition|Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
11159895|NCT01937975|BG000|Baseline|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159896|NCT01937975|BG001|Baseline|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159897|NCT01937975|BG002|Baseline|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159898|NCT01937975|BG003|Baseline|Total|Total of all reporting groups
11159899|NCT01937975|FG000|Participant Flow|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159900|NCT01937975|FG001|Participant Flow|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159901|NCT01937975|FG002|Participant Flow|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159902|NCT01937975|OG000|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
11159903|NCT01937975|OG001|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159904|NCT01937975|OG002|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159905|NCT01937975|OG001|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159906|NCT01937975|OG000|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
11159907|NCT01937975|OG002|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
11159908|NCT01937975|OG002|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
11159909|NCT01937975|EG000|Reported Event|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159910|NCT01937975|EG001|Reported Event|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159911|NCT01937975|EG002|Reported Event|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
11159912|NCT01938040|BG000|Baseline|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
11159913|NCT01938040|BG001|Baseline|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
11159914|NCT01938040|BG002|Baseline|Total|Total of all reporting groups
11159915|NCT01938040|FG000|Participant Flow|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
11159916|NCT01938040|FG001|Participant Flow|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
11159917|NCT01938040|OG000|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
11159918|NCT01938040|OG001|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
11159919|NCT01938040|OG000|Outcome|Ibuprofen|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
11159920|NCT01938040|OG001|Outcome|Sugar Water|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
11159921|NCT01938040|OG000|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
11159922|NCT01938040|OG001|Outcome|Ibuprofen|800 mg in 100mL of normal saline over 5 minutes
11159923|NCT01938040|OG000|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
11159924|NCT01938040|OG001|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
11159925|NCT01938040|EG000|Reported Event|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
11159926|NCT01938040|EG001|Reported Event|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
11159927|NCT01938066|BG000|Baseline|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
11159928|NCT01938066|BG001|Baseline|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
11159929|NCT01938066|BG002|Baseline|Total|Total of all reporting groups
11159930|NCT01938066|FG000|Participant Flow|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
11159931|NCT01938066|FG001|Participant Flow|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
11159932|NCT01938066|OG000|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
11159933|NCT01938066|OG001|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
11159934|NCT01938066|EG000|Reported Event|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
11159935|NCT01938066|EG001|Reported Event|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
11159936|NCT01938079|BG000|Baseline|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
11159937|NCT01938079|BG001|Baseline|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
11159938|NCT01938079|BG002|Baseline|Total|Total of all reporting groups
11159939|NCT01938079|FG000|Participant Flow|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
11159940|NCT01938079|FG001|Participant Flow|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
11159941|NCT01938079|OG000|Outcome|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
11173934|NCT02018887|OG006|Outcome|Cohort 2 - 60 mg LY2969822|60 mg LY2969822 administered once, PO.
11173935|NCT02018887|OG007|Outcome|Cohort 2 - 20 mg LY2969822|20 mg LY2969822 administered once, PO.
11159942|NCT01938079|OG001|Outcome|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
11159943|NCT01938079|EG000|Reported Event|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
11159944|NCT01938079|EG001|Reported Event|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
11159945|NCT01938170|BG000|Baseline|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
11159946|NCT01938170|FG000|Participant Flow|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
11159947|NCT01938170|OG000|Outcome|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
11159948|NCT01938170|EG000|Reported Event|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
11159949|NCT01938378|BG000|Baseline|Pediatric Patients Undergoing TPE Age Group 1|Ages 2-<12
11159950|NCT01938378|BG001|Baseline|Pediatric Patients Undergoing TPE Age Group 2|Ages 12-<17
11159951|NCT01938378|BG002|Baseline|Pediatric Patients Undergoing TPE Age Group 3|Ages ≥17
11159952|NCT01938378|BG003|Baseline|Total|Total of all reporting groups
11159953|NCT01938378|FG000|Participant Flow|Pediatric Patients Undergoing TPE|"octaplas™~Octaplas™: octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg."
11159954|NCT01938378|OG000|Outcome|Pediatric Patients Undergoing TPE Age Group 1|Ages 2-<12
11159955|NCT01938378|OG001|Outcome|Pediatric Patients Undergoing TPE Age Group 2|Ages 12 - <17
11159956|NCT01938378|OG002|Outcome|Pediatric Patients Undergoing TPE Age Group 3|Ages ≥17
11159957|NCT01938378|OG003|Outcome|All Patients|All ages
11159958|NCT01938378|OG000|Outcome|Pre-TPE|Value pre-TPE
11159959|NCT01938378|OG001|Outcome|Post-TPE|Value post-TPE
11159960|NCT01938378|OG002|Outcome|Change From Pre-TPE|Change in level from Pre-TPE to Post-TPE
11159961|NCT01938378|OG001|Outcome|During TPE|Value during TPE
11159962|NCT01938378|OG002|Outcome|Change From Pre-TPE to During TPE|Mean change from Pre-TPE to During TPE
11159963|NCT01938378|OG003|Outcome|Follow-Up|Follow-up is 24 (+/-2) hours after TPE end.
11159964|NCT01938378|OG004|Outcome|Change From Pre-TPE to Follow-Up|Mean change in level from Pre-TPE to Follow-Up
11159965|NCT01938378|OG000|Outcome|Pediatric Patients Undergoing TPE|"octaplas™~Octaplas™: octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg."
11159966|NCT01938378|EG000|Reported Event|Pediatric Patients Undergoing TPE Age Group 1|Ages 2-<12
11159967|NCT01938378|EG001|Reported Event|Pediatric Patients Undergoing TPE Age Group 2|Ages 12 - <17
11159968|NCT01938378|EG002|Reported Event|Pediatric Patients Undergoing TPE Age Group 3|Ages ≥17
11159969|NCT01938378|EG003|Reported Event|All Patients|All ages
11159970|NCT01938391|BG000|Baseline|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
11159971|NCT01938391|FG000|Participant Flow|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
11159972|NCT01938391|OG000|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
11159973|NCT01938391|EG000|Reported Event|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
11159974|NCT01938430|BG000|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
11159975|NCT01938430|BG001|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11159976|NCT01938430|BG002|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11159977|NCT01938430|BG003|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11159978|NCT01938430|BG004|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
11173936|NCT02018887|OG008|Outcome|Cohorts 3-7 - Placebo|Placebo administered QD or BID, PO, for 14 days.
11159979|NCT01938430|BG005|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
11159980|NCT01938430|BG006|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
11159981|NCT01938430|BG007|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
11159982|NCT01938430|BG008|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
11159983|NCT01938430|BG009|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11159984|NCT01938430|BG010|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11159985|NCT01938430|BG011|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11159986|NCT01938430|BG012|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
11159987|NCT01938430|BG013|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11159988|NCT01938430|BG014|Baseline|Total|Total of all reporting groups
11159989|NCT01938430|FG000|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
11159990|NCT01938430|FG001|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11159991|NCT01938430|FG002|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11159992|NCT01938430|FG003|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11159993|NCT01938430|FG004|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis"
11159994|NCT01938430|FG005|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
11159995|NCT01938430|FG006|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
11159996|NCT01938430|FG007|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
11159997|NCT01938430|FG008|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
11159998|NCT01938430|FG009|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11159999|NCT01938430|FG010|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11160000|NCT01938430|FG011|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11173937|NCT02018887|OG009|Outcome|Cohort 3 - 20 mg LY2969822 QD|20 mg LY2969822 administered QD, PO, for 14 days.
11160001|NCT01938430|FG012|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
11160002|NCT01938430|FG013|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11160003|NCT01938430|OG000|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
11160004|NCT01938430|OG001|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11160005|NCT01938430|OG002|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11160006|NCT01938430|OG003|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11160007|NCT01938430|OG004|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
11160008|NCT01938430|OG005|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
11160009|NCT01938430|OG006|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
11160010|NCT01938430|OG007|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
11160011|NCT01938430|OG008|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
11160012|NCT01938430|OG009|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11160013|NCT01938430|OG010|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11160014|NCT01938430|OG011|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11160015|NCT01938430|OG012|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
11160016|NCT01938430|OG013|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11160017|NCT01938430|OG000|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
11160018|NCT01938430|OG000|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11160019|NCT01938430|OG001|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11160020|NCT01938430|OG002|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
11160021|NCT01938430|OG003|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
11160022|NCT01938430|OG004|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11160023|NCT01938430|OG005|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11160024|NCT01938430|OG006|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11160025|NCT01938430|OG004|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
11160026|NCT01938430|OG005|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
11160027|NCT01938430|OG006|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
11160028|NCT01938430|OG007|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11160029|NCT01938430|OG008|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11160030|NCT01938430|OG009|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11160031|NCT01938430|OG000|Outcome|Cohort A: Baseline CPT Class A (24 wk)|Includes participants in Cohort A (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160032|NCT01938430|OG001|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160033|NCT01938430|OG002|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160034|NCT01938430|OG003|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160035|NCT01938430|OG004|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160036|NCT01938430|OG005|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160037|NCT01938430|OG006|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160038|NCT01938430|OG007|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160039|NCT01938430|OG008|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160040|NCT01938430|OG009|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160041|NCT01938430|OG010|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11160042|NCT01938430|EG000|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
11160043|NCT01938430|EG001|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11160044|NCT01938430|EG002|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11160045|NCT01938430|EG003|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11160046|NCT01938430|EG004|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
11160047|NCT01938430|EG005|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
11160048|NCT01938430|EG006|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
11160049|NCT01938430|EG007|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
11160050|NCT01938430|EG008|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
11160051|NCT01938430|EG009|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11160052|NCT01938430|EG010|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
11160053|NCT01938430|EG011|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11160054|NCT01938430|EG012|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
11160055|NCT01938430|EG013|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11160056|NCT01938573|BG000|Baseline|Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
11160057|NCT01938573|FG000|Participant Flow|Phase 2|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
11160058|NCT01938573|FG001|Participant Flow|Phase I|Sirolimus 35 mg PO day -2, cisplatin 70 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1 and 8, every 21 days
11160059|NCT01938573|OG000|Outcome|Phase 1 - Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
11160060|NCT01938573|OG000|Outcome|Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
11160061|NCT01938573|EG000|Reported Event|Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
11160062|NCT01938625|BG000|Baseline|Cyclosporine|Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
11160063|NCT01938625|BG001|Baseline|Tacrolimus|Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
11160064|NCT01938625|BG002|Baseline|Total|Total of all reporting groups
11160065|NCT01938625|FG000|Participant Flow|Cyclosporine|Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
11160066|NCT01938625|FG001|Participant Flow|Tacrolimus|Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
11160067|NCT01938625|OG000|Outcome|Cyclosporine|Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
11160068|NCT01938625|OG001|Outcome|Tacrolimus|Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
11160069|NCT01938625|EG000|Reported Event|Cyclosporine|Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
11160070|NCT01938625|EG001|Reported Event|Tacrolimus|Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
11160071|NCT01938664|BG000|Baseline|Candesartan w Cognitive Behavior Therapy|"Titration up to 8mg wk 1-4. Continue on 8mg thru wk 8. CBT optional thru study.~Candesartan with CBT: 8 mg, po (by mouth)"
11160072|NCT01938664|BG001|Baseline|Placebo w Cognitive Behavior Therapy|"Sugar pill to mimic Candesartan for study duration. CBT optional thru study.~Placebo with CBT"
11160073|NCT01938664|BG002|Baseline|Total|Total of all reporting groups
11160074|NCT01938664|FG000|Participant Flow|Candesartan w Cognitive Behavior Therapy|"Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study.~Candesartan with CBT: 8 mg, po (by mouth)"
11160075|NCT01938664|FG001|Participant Flow|Placebo w Cognitive Behavior Therapy|"Sugar pill to mimic Candesartan for study duration. CBT optional thru study.~Placebo with CBT"
11160076|NCT01938664|OG000|Outcome|Candesartan w Cognitive Behavior Therapy|"Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study.~Candesartan with CBT: 8 mg, po (by mouth)"
11160077|NCT01938664|OG001|Outcome|Placebo w Cognitive Behavior Therapy|"Sugar pill to mimic Candesartan for study duration. CBT optional thru study.~Placebo with CBT"
11160078|NCT01938664|EG000|Reported Event|Candesartan w Cognitive Behavior Therapy|"Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study.~Candesartan with CBT: 8 mg, po (by mouth)"
11160079|NCT01938664|EG001|Reported Event|Placebo w Cognitive Behavior Therapy|"Sugar pill to mimic Candesartan for study duration. CBT optional thru study.~Placebo with CBT"
11160080|NCT01938846|BG000|Baseline|BI 860585 Monotherapy|Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
11160081|NCT01938846|BG001|Baseline|BI 860585 + Exemestane|Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
11160082|NCT01938846|BG002|Baseline|BI 860585 + Paclitaxel|Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter^2 for the first dose level/treatment cohort and 80 milligram/meter^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160083|NCT01938846|BG003|Baseline|Total|Total of all reporting groups
11160084|NCT01938846|FG000|Participant Flow|BI 860585 Monotherapy|Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
11160085|NCT01938846|FG001|Participant Flow|BI 860585 + Exemestane|Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
11160086|NCT01938846|FG002|Participant Flow|BI 860585 + Paclitaxel|Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter^2 for the first dose level/treatment cohort and 80 milligram/meter^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160087|NCT01938846|OG000|Outcome|BI 860585 Monotherapy|Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
11160088|NCT01938846|OG001|Outcome|BI 860585 + Exemestane|Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
11160089|NCT01938846|OG002|Outcome|BI 860585 + Paclitaxel|Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter^2 for the first dose level/treatment cohort and 80 milligram/meter^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160090|NCT01938846|OG000|Outcome|5 mg BI 860585|Continuous daily oral dose of 5 milligram/day (starting dose) over 28-day treatment courses of BI 860585 Monotherapy
11160091|NCT01938846|OG001|Outcome|10 mg BI 860585|Continuous daily oral dose of 10 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160092|NCT01938846|OG002|Outcome|20 mg BI 860585|Continuous daily oral dose of 20 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160093|NCT01938846|OG003|Outcome|40 mg BI 860585|Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160094|NCT01938846|OG004|Outcome|80 mg BI 860585|Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160095|NCT01938846|OG005|Outcome|120 mg BI 860585|Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160096|NCT01938846|OG006|Outcome|160 mg BI 860585|Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160097|NCT01938846|OG007|Outcome|220 mg BI 860585|Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160098|NCT01938846|OG008|Outcome|300 mg BI 860585|Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160099|NCT01938846|OG009|Outcome|40 mg BI 860585+25 mg Exemestane|Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
11160100|NCT01938846|OG010|Outcome|80 mg BI 860585+25 mg Exemestane|Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
11160101|NCT01938846|OG011|Outcome|120 mg BI 860585+25 mg Exemestane|Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
11160102|NCT01938846|OG012|Outcome|160 mg BI 860585+25 mg Exemestane|Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
11160103|NCT01938846|OG013|Outcome|80 mg BI 860585+60 mg/m^2 Paclitaxel|Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160104|NCT01938846|OG014|Outcome|80 mg BI 860585+80 mg/m^2 Paclitaxel|Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160105|NCT01938846|OG015|Outcome|120 mg BI 860585+80 mg/m^2 Paclitaxel|Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160106|NCT01938846|OG016|Outcome|160 mg BI 860585+80 mg/m^2 Paclita|Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel
11160107|NCT01938846|EG000|Reported Event|5 mg BI 860585|Continuous daily oral dose of 5 milligram/day (starting dose) over 28-day treatment courses of BI 860585 Monotherapy
11160108|NCT01938846|EG001|Reported Event|10 mg BI 860585|Continuous daily oral dose of 10 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160109|NCT01938846|EG002|Reported Event|20 mg BI 860585|Continuous daily oral dose of 20 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160110|NCT01938846|EG003|Reported Event|40 mg BI 860585|Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160111|NCT01938846|EG004|Reported Event|80 mg BI 860585|Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160112|NCT01938846|EG005|Reported Event|120 mg BI 860585|Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160113|NCT01938846|EG006|Reported Event|160 mg BI 860585|Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160114|NCT01938846|EG007|Reported Event|220 mg BI 860585|Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160115|NCT01938846|EG008|Reported Event|300 mg BI 860585|Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
11160116|NCT01938846|EG009|Reported Event|40 mg BI 860585+25 mg Exemestane|Patients were administered with daily oral dose of 40 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
11160117|NCT01938846|EG010|Reported Event|80 mg BI 860585+25 mg Exemestane|Patients were administered with daily oral dose of 80 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
11160118|NCT01938846|EG011|Reported Event|120 mg BI 860585+25 mg Exemestane|Patients were administered with daily oral dose of 120 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
11160119|NCT01938846|EG012|Reported Event|160 mg BI 860585+25 mg Exemestane|Patients were administered with daily oral dose of 160 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
11160120|NCT01938846|EG013|Reported Event|220 mg BI 860585+25 mg Exemestane|Patients were administered with daily oral dose of 220 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
11160121|NCT01938846|EG014|Reported Event|80 mg BI 860585+60 mg/m^2 Paclitaxel|Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160122|NCT01938846|EG015|Reported Event|80 mg BI 860585+80 mg/m^2 Paclitaxel|Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160123|NCT01938846|EG016|Reported Event|120 mg BI 860585+80 mg/m^2 Paclitaxel|Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160124|NCT01938846|EG017|Reported Event|160 mg BI 860585+80 mg/m^2 Paclitaxel|Patients were administered with 160 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160125|NCT01938846|EG018|Reported Event|220 mg BI 860585+80 mg/m^2 Paclitaxel|Patients were administered with 220 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
11160126|NCT01938989|BG000|Baseline|Overall|Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment.
11160127|NCT01938989|FG000|Participant Flow|Clear, Then Blue Light Filter|Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
11160128|NCT01938989|FG001|Participant Flow|Blue Light Filter, Then Clear|Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
11160129|NCT01938989|OG000|Outcome|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
11160130|NCT01938989|OG001|Outcome|Clear|Clear clip-on glasses worn over habitual correction
11160131|NCT01938989|EG000|Reported Event|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
11160132|NCT01938989|EG001|Reported Event|Clear|Clear clip-on glasses worn over habitual correction
11160133|NCT01939002|BG000|Baseline|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
11160134|NCT01939002|BG001|Baseline|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
11160135|NCT01939002|BG002|Baseline|Total|Total of all reporting groups
11160136|NCT01939002|FG000|Participant Flow|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
11173938|NCT02018887|OG010|Outcome|Cohort 4 - 40 mg LY2969822 QD Titrated|Up to 40 mg LY2969822 administered QD, PO, for 14 days. Titration: 6 mg QD for 3 days, 20 mg QD for 2 days, and 40 mg QD for 9 days.
11160137|NCT01939002|FG001|Participant Flow|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
11160138|NCT01939002|OG000|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently."
11160139|NCT01939002|OG000|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
11160140|NCT01939002|OG001|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
11160141|NCT01939002|OG002|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
11160142|NCT01939002|OG000|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
11160143|NCT01939002|OG000|Outcome|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
11160144|NCT01939002|OG001|Outcome|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
11160145|NCT01939002|EG000|Reported Event|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
11160146|NCT01939002|EG001|Reported Event|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
11160147|NCT01939028|BG000|Baseline|Diagnostic (SLN Mapping, Biopsy, Surgery)|Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.
11160148|NCT01939028|FG000|Participant Flow|Diagnostic (SLN Mapping, Biopsy, Surgery)|"Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.~lymph node mapping: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution~sentinel lymph node biopsy: Undergo SLN biopsy~isosulfan blue: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution~indocyanine green solution: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution~therapeutic conventional surgery: Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy~lymphadenectomy: Undergo para-aortic lymphadenectomy"
11160149|NCT01939028|OG000|Outcome|Diagnostic (SLN Mapping, Biopsy, Surgery)|Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.
11160150|NCT01939028|EG000|Reported Event|Diagnostic (SLN Mapping, Biopsy, Surgery)|Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.
11173939|NCT02018887|OG011|Outcome|Cohort 5 - 80 mg LY2969822 QD Titrated|Up to 80 mg LY2969822 administered QD, PO, for 14 days. Titration: 6 mg QD for 2 days, 20 mg QD for 2 days, 40 mg QD for 2 days and 80 mg QD for 8 days.
11160151|NCT01939145|BG000|Baseline|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
11160152|NCT01939145|BG001|Baseline|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
11160153|NCT01939145|BG002|Baseline|Total|Total of all reporting groups
11160154|NCT01939145|FG000|Participant Flow|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
11160155|NCT01939145|FG001|Participant Flow|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
11160156|NCT01939145|OG000|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
11160157|NCT01939145|OG001|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
11160158|NCT01939145|EG000|Reported Event|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
11160159|NCT01939145|EG001|Reported Event|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
10887773|NCT00502671|BG000|Baseline|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
11160160|NCT01939158|BG000|Baseline|ACWY1d Group|Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
11160161|NCT01939158|BG001|Baseline|ACWY2d Group|Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
11160162|NCT01939158|BG002|Baseline|Co-ad Group|Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
11160163|NCT01939158|BG003|Baseline|PCV13 Group|Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
11160164|NCT01939158|BG004|Baseline|Total|Total of all reporting groups
11160165|NCT01939158|FG000|Participant Flow|ACWY1d Group|Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
11160166|NCT01939158|FG001|Participant Flow|ACWY2d Group|Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
11160167|NCT01939158|FG002|Participant Flow|Co-ad Group|Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
11160168|NCT01939158|FG003|Participant Flow|PCV13 Group|Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
11160169|NCT01939158|OG000|Outcome|ACWY1d Group|Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
11160170|NCT01939158|OG001|Outcome|ACWY2d Group|Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
11160171|NCT01939158|OG002|Outcome|Co-ad Group|Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
11160172|NCT01939158|OG000|Outcome|ACWY2d Group|Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
11160173|NCT01939158|OG000|Outcome|Co-ad Group|Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
11160174|NCT01939158|OG001|Outcome|PCV13 Group|Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
11160175|NCT01939158|OG000|Outcome|PCV13 Group|Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
11160176|NCT01939158|OG003|Outcome|PCV13 Group|Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
11160177|NCT01939158|EG000|Reported Event|ACWY1d Group|Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.
11160178|NCT01939158|EG001|Reported Event|ACWY2d Group|Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
11160179|NCT01939158|EG002|Reported Event|Co-ad Group|Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
11160180|NCT01939158|EG003|Reported Event|PCV13 Group|Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
11160181|NCT01939197|BG000|Baseline|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
11160182|NCT01939197|BG001|Baseline|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
11160183|NCT01939197|BG002|Baseline|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
11160184|NCT01939197|BG003|Baseline|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
11160185|NCT01939197|BG004|Baseline|Part 2: GT1 Analysis Group|Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160186|NCT01939197|BG005|Baseline|Part 2: Arm G|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160187|NCT01939197|BG006|Baseline|Part 2: GT4 Analysis Group|Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
11160188|NCT01939197|BG007|Baseline|Total|Total of all reporting groups
11160189|NCT01939197|FG000|Participant Flow|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
11160190|NCT01939197|FG001|Participant Flow|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
11160191|NCT01939197|FG002|Participant Flow|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
11160192|NCT01939197|FG003|Participant Flow|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
11160193|NCT01939197|FG004|Participant Flow|Part 2: GT1 Analysis Group|Participants with HCV genotype (GT)1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160194|NCT01939197|FG005|Participant Flow|Part 2: Arm G|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160195|NCT01939197|FG006|Participant Flow|GT4 Analysis Group|"Participants with HCV GT4 at screening in Arms K and L (no participants enrolled in Arm L).~Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily"
11173940|NCT02018887|OG012|Outcome|Cohort 6 - 80 mg LY2969822 BID Titrated|Up to 80 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.
11160196|NCT01939197|OG000|Outcome|Part 2: GT1 Analysis Group|Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160197|NCT01939197|OG000|Outcome|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
11160198|NCT01939197|OG001|Outcome|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
11160199|NCT01939197|OG000|Outcome|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
11160200|NCT01939197|OG001|Outcome|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
11160201|NCT01939197|OG002|Outcome|Part 1b: Total|"Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily~Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily"
11160202|NCT01939197|OG000|Outcome|Part 2: Arm F|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160203|NCT01939197|OG001|Outcome|Part 2: Arm G|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160204|NCT01939197|OG000|Outcome|Part 2: GT4 Analysis Group|Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
11160205|NCT01939197|OG001|Outcome|Part 2: Arm K|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
11160206|NCT01939197|OG001|Outcome|Part 2: Arm E|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160207|NCT01939197|OG002|Outcome|Part 2: Arm F|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160208|NCT01939197|OG003|Outcome|Part 2: Arm I|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160209|NCT01939197|OG004|Outcome|Part 2: Arm J|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160210|NCT01939197|OG005|Outcome|Part 2: GT4 Analysis Group|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
11160211|NCT01939197|OG006|Outcome|Group 2: Arm K|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
11160212|NCT01939197|OG005|Outcome|Part 2: GT4 Analysis Group|Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
11160213|NCT01939197|OG002|Outcome|Part 1b Total|"Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily~Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily"
11160214|NCT01939197|EG000|Reported Event|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
11160215|NCT01939197|EG001|Reported Event|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
11160216|NCT01939197|EG002|Reported Event|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
11160217|NCT01939197|EG003|Reported Event|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
11160218|NCT01939197|EG004|Reported Event|Part 2: Arm E|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160219|NCT01939197|EG005|Reported Event|Part 2: Arm F|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160220|NCT01939197|EG006|Reported Event|Part 2: Arm G|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160221|NCT01939197|EG007|Reported Event|Part 2: Arm I|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160222|NCT01939197|EG008|Reported Event|Part 2: Arm J|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
11160223|NCT01939197|EG009|Reported Event|Part 2: Arm K|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
11160224|NCT01939288|BG000|Baseline|Group 1|"Half of recruited subjects (n=5)~Neuromuscular stimulator followed by IPC"
11160225|NCT01939288|BG001|Baseline|Group 2|"Other half of recruited subjects (n=5)~IPC followed by neuromuscular stimulator"
11160226|NCT01939288|BG002|Baseline|Total|Total of all reporting groups
11160227|NCT01939288|FG000|Participant Flow|Group 1|"Half of recruited subjects (n=5)~Neuromuscular stimulator followed by IPC"
11160228|NCT01939288|FG001|Participant Flow|Group 2|"Other half of recruited subjects (n=5)~IPC followed by neuromuscular stimulator"
11160229|NCT01939288|OG000|Outcome|Overall Summation|Grouping all subject together so that no one intervention in a certain order skews results
11160230|NCT01939288|EG000|Reported Event|Group 1|Neuromuscular stimulator
11160231|NCT01939288|EG001|Reported Event|Group 2|Intermittent pneumatic compression
11160232|NCT01939301|BG000|Baseline|Inhaled Nitric Oxide|"Inhaled nitric oxide~Nitric Oxide + oxygen"
11160233|NCT01939301|BG001|Baseline|Sham|"oxygen~Nitrogen + Oxygen"
11349178|NCT04115358|EG001|Reported Event|Formocresol|"0,1 ml to the orifice of the root canals of the primary molar~Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material."
11160234|NCT01939301|BG002|Baseline|Total|Total of all reporting groups
11160235|NCT01939301|FG000|Participant Flow|Inhaled Nitric Oxide|"Inhaled nitric oxide~Nitric Oxide + oxygen"
11160236|NCT01939301|FG001|Participant Flow|Sham|"oxygen~Nitrogen + Oxygen"
11160237|NCT01939301|OG000|Outcome|Inhaled Nitric Oxide|"Inhaled nitric oxide~Nitric Oxide + oxygen"
11160238|NCT01939301|OG001|Outcome|Sham|"oxygen~Nitrogen + Oxygen"
11160239|NCT01939301|EG000|Reported Event|Inhaled Nitric Oxide|"Inhaled nitric oxide~Nitric Oxide + oxygen"
11160240|NCT01939301|EG001|Reported Event|Sham|"oxygen~Nitrogen + Oxygen"
11160241|NCT01939314|BG000|Baseline|Bupivacaine|Bupivacaine delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
11160242|NCT01939314|BG001|Baseline|Normal Saline|Normal Saline delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
11160243|NCT01939314|BG002|Baseline|Total|Total of all reporting groups
11160244|NCT01939314|FG000|Participant Flow|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
11160245|NCT01939314|FG001|Participant Flow|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
11160246|NCT01939314|OG000|Outcome|Bupivacaine|Bupivicaine .03ml to each nare
11160247|NCT01939314|OG001|Outcome|Normal Saline|Normal Saline .03ml to each nare
11160248|NCT01939314|OG000|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
11160249|NCT01939314|OG001|Outcome|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
11160250|NCT01939314|EG000|Reported Event|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
11160251|NCT01939314|EG001|Reported Event|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
11160252|NCT01939353|BG000|Baseline|Centanafadine SR 100-500 mg|Following a 1-week SB placebo run-in treatment, participants with <30% improvement and ≥28 total score on Adult ADHD-RS-IV scale score received CTN 100 mg, SR tablet, once daily (1 tablet in the morning) on Days 1 and 2, followed by 200 mg, SR tablets, twice daily (1 tablet in the morning and 1 tablet 5 hours later) on Days 3 and 4, followed by 300 mg, SR tablets, twice daily (2 tablets in the morning and 1 tablet 5 hours later) on Days 5, 6, and 7. After 1 week of treatment, CTN doses were maintained or titrated in 100-mg increments up to the maximum of 500 mg daily or reduced based on the safety and tolerability, as judged by the investigator at Weeks 2, 3 and 4.
11160253|NCT01939353|FG000|Participant Flow|Centanafadine SR 100-500 mg|Following a 1-week SB placebo run-in treatment, participants with <30% improvement and ≥28 total score on Adult ADHD-RS-IV scale score received CTN 100 mg, SR tablet, once daily (1 tablet in the morning) on Days 1 and 2, followed by 200 mg, SR tablets, twice daily (1 tablet in the morning and 1 tablet 5 hours later) on Days 3 and 4, followed by 300 mg, SR tablets, twice daily (2 tablets in the morning and 1 tablet 5 hours later) on Days 5, 6, and 7. After 1 week of treatment, CTN doses were maintained or titrated in 100-mg increments up to the maximum of 500 mg daily or reduced based on the safety and tolerability, as judged by the investigator at Weeks 2, 3 and 4.
11160254|NCT01939353|OG000|Outcome|Centanafadine SR 100-500 mg|Following a 1-week SB placebo run-in treatment, participants with <30% improvement and ≥28 total score on Adult ADHD-RS-IV scale score received CTN 100 mg, SR tablet, once daily (1 tablet in the morning) on Days 1 and 2, followed by 200 mg, SR tablets, twice daily (1 tablet in the morning and 1 tablet 5 hours later) on Days 3 and 4, followed by 300 mg, SR tablets, twice daily (2 tablets in the morning and 1 tablet 5 hours later) on Days 5, 6, and 7. After 1 week of treatment, CTN doses were maintained or titrated in 100-mg increments up to the maximum of 500 mg daily or reduced based on the safety and tolerability, as judged by the investigator at Weeks 2, 3 and 4.
11160255|NCT01939353|EG000|Reported Event|Centanafadine SR 100-500 mg|Following a 1-week SB placebo run-in treatment, participants with <30% improvement and ≥28 total score on Adult ADHD-RS-IV scale score received CTN 100 mg, SR tablet, once daily (1 tablet in the morning) on Days 1 and 2, followed by 200 mg, SR tablets, twice daily (1 tablet in the morning and 1 tablet 5 hours later) on Days 3 and 4, followed by 300 mg, SR tablets, twice daily (2 tablets in the morning and 1 tablet 5 hours later) on Days 5, 6, and 7. After 1 week of treatment, CTN doses were maintained or titrated in 100-mg increments up to the maximum of 500 mg daily or reduced based on the safety and tolerability, as judged by the investigator at Weeks 2, 3 and 4.
11160256|NCT01939366|BG000|Baseline|Cebranopadol 100 µg|Cebranopadol 100 µg: Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.
11160257|NCT01939366|BG001|Baseline|Cebranopadol 300 µg|Cebranopadol 300 µg: Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.
11160258|NCT01939366|BG002|Baseline|Cebranopadol 600 µg|Cebranopadol 600 µg: Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.
11160259|NCT01939366|BG003|Baseline|Pregabalin|Pregabalin: Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
11160260|NCT01939366|BG004|Baseline|Matching Placebo|Matching Placebo: Placebo will be matched to pregabalin and cebranopadol.
11160261|NCT01939366|BG005|Baseline|Total|Total of all reporting groups
11160262|NCT01939366|FG000|Participant Flow|Cebranopadol 100 µg|Cebranopadol 100 µg: Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.
11160263|NCT01939366|FG001|Participant Flow|Cebranopadol 300 µg|Cebranopadol 300 µg: Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.
11160264|NCT01939366|FG002|Participant Flow|Cebranopadol 600 µg|Cebranopadol 600 µg: Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.
11160265|NCT01939366|FG003|Participant Flow|Pregabalin|Pregabalin: Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
11160266|NCT01939366|FG004|Participant Flow|Matching Placebo|Matching Placebo: Placebo will be matched to pregabalin and cebranopadol.
11160267|NCT01939366|OG000|Outcome|Cebranopadol 100 µg|Cebranopadol 100 µg: Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.
11160268|NCT01939366|OG001|Outcome|Cebranopadol 300 µg|Cebranopadol 300 µg: Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.
11160269|NCT01939366|OG002|Outcome|Cebranopadol 600 µg|Cebranopadol 600 µg: Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.
11160270|NCT01939366|OG003|Outcome|Pregabalin|Pregabalin: Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
11160271|NCT01939366|OG004|Outcome|Matching Placebo|Matching Placebo: Placebo will be matched to pregabalin and cebranopadol.
11160272|NCT01939366|EG000|Reported Event|Cebranopadol 100 µg|Cebranopadol 100 µg: Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.
11160273|NCT01939366|EG001|Reported Event|Cebranopadol 300 µg|Cebranopadol 300 µg: Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.
11160274|NCT01939366|EG002|Reported Event|Cebranopadol 600 µg|Cebranopadol 600 µg: Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.
11160275|NCT01939366|EG003|Reported Event|Pregabalin|Pregabalin: Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
11160276|NCT01939366|EG004|Reported Event|Matching Placebo|Matching Placebo: Placebo will be matched to pregabalin and cebranopadol.
11160277|NCT01939405|BG000|Baseline|Standard Physical Activity Counseling|standard pediatric physical activity counseling
11160278|NCT01939405|BG001|Baseline|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
11160279|NCT01939405|BG002|Baseline|Total|Total of all reporting groups
11160280|NCT01939405|FG000|Participant Flow|Standard Physical Activity Counseling|standard pedatric physical activity counseling
11160281|NCT01939405|FG001|Participant Flow|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
11160282|NCT01939405|OG000|Outcome|Standard Physical Activity Counseling|standard pedatric physical activity counseling
11160283|NCT01939405|OG001|Outcome|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
11160284|NCT01939405|EG000|Reported Event|Standard Physical Activity Counseling|standard pedatric physical activity counseling
11160285|NCT01939405|EG001|Reported Event|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
11160286|NCT01939496|BG000|Baseline|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
11160287|NCT01939496|BG001|Baseline|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
11160288|NCT01939496|BG002|Baseline|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
11160289|NCT01939496|BG003|Baseline|Total|Total of all reporting groups
11160290|NCT01939496|FG000|Participant Flow|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
11160291|NCT01939496|FG001|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
11160292|NCT01939496|FG002|Participant Flow|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
11160293|NCT01939496|OG000|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
11160294|NCT01939496|OG001|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
11160295|NCT01939496|OG002|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
11160296|NCT01939496|EG000|Reported Event|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
11160297|NCT01939496|EG001|Reported Event|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
11160298|NCT01939496|EG002|Reported Event|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
11160299|NCT01939548|BG000|Baseline|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11173941|NCT02018887|OG013|Outcome|Cohort 7 - 40 mg LY2969822 BID Rapidly Titrated|Up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, and 40 mg BID for 12 days.
11160300|NCT01939548|BG001|Baseline|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160301|NCT01939548|BG002|Baseline|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160302|NCT01939548|BG003|Baseline|Total|Total of all reporting groups
11160303|NCT01939548|FG000|Participant Flow|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160304|NCT01939548|FG001|Participant Flow|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160305|NCT01939548|FG002|Participant Flow|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160306|NCT01939548|OG000|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160307|NCT01939548|OG001|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160308|NCT01939548|OG002|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160309|NCT01939548|EG000|Reported Event|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160310|NCT01939548|EG001|Reported Event|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160311|NCT01939548|EG002|Reported Event|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
11160312|NCT01939899|BG000|Baseline|Lead-in Dose Finding Phase: Ixazomib 4 mg|Ixazomib 4 milligram (mg), solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or progressive disease (PD) or the start of alternate therapies during lead-in dose finding in non-hodgkin lymphoma (NHL) participants.
11160313|NCT01939899|BG001|Baseline|Lead-in Dose Finding Phase: Ixazomib 5.3 mg|Ixazomib 5.3 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160314|NCT01939899|BG002|Baseline|Lead-in Dose Finding Phase: Ixazomib 7.0 mg|Ixazomib 7 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160315|NCT01939899|BG003|Baseline|Phase 2: PSMB1 Positive|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in relapsed Or refractory follicular lymphoma (RRFL) participants.
11160316|NCT01939899|BG004|Baseline|Phase 2: PSMB1 Negative|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in RRFL participants.
11160317|NCT01939899|BG005|Baseline|Total|Total of all reporting groups
11160318|NCT01939899|FG000|Participant Flow|Lead-in Dose Finding Phase: Ixazomib 4 mg|Ixazomib 4 milligram (mg), solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or progressive disease (PD) or the start of alternate therapies during lead-in dose finding in non-hodgkin lymphoma (NHL) participants.
11160319|NCT01939899|FG001|Participant Flow|Lead-in Dose Finding Phase: Ixazomib 5.3 mg|Ixazomib 5.3 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11173942|NCT02018887|OG014|Outcome|Cohort 8 - Placebo BID|Placebo administered BID, PO, for 14 days.
11160320|NCT01939899|FG002|Participant Flow|Lead-in Dose Finding Phase: Ixazomib 7.0 mg|Ixazomib 7 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160321|NCT01939899|FG003|Participant Flow|Phase 2: PSMB1 Positive|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in relapsed Or refractory follicular lymphoma (RRFL) participants.
11160322|NCT01939899|FG004|Participant Flow|Phase 2: PSMB1 Negative|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in RRFL participants.
11160323|NCT01939899|OG000|Outcome|Lead-in Dose Finding Phase: Ixazomib 4 mg|Ixazomib 4 milligram (mg), solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or progressive disease (PD) or the start of alternate therapies during lead-in dose finding in non-hodgkin lymphoma (NHL) participants.
11160324|NCT01939899|OG001|Outcome|Lead-in Dose Finding Phase: Ixazomib 5.3 mg|Ixazomib 5.3 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160325|NCT01939899|OG002|Outcome|Lead-in Dose Finding Phase: Ixazomib 7.0 mg|Ixazomib 7 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160326|NCT01939899|OG003|Outcome|Phase 2: PSMB1 Positive|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in relapsed Or refractory follicular lymphoma (RRFL) participants.
11160327|NCT01939899|OG004|Outcome|Phase 2: PSMB1 Negative|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in RRFL participants.
11160328|NCT01939899|OG000|Outcome|Lead-in Dose Finding Phase: All Participants|Ixazomib 5.3 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160329|NCT01939899|OG000|Outcome|Lead-in Dose Finding: Ixazomib 5.3 mg (RP2D)|Ixazomib 5.3 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160330|NCT01939899|OG001|Outcome|Phase 2: PSMB1 Positive|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in relapsed Or refractory follicular lymphoma (RRFL) participants.
11160331|NCT01939899|OG002|Outcome|Phase 2: PSMB1 Negative|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in RRFL participants.
11160332|NCT01939899|OG000|Outcome|Phase 2: PSMB1 Positive|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in relapsed Or refractory follicular lymphoma (RRFL) participants.
11160333|NCT01939899|OG001|Outcome|Phase 2: PSMB1 Negative|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in RRFL participants.
11160334|NCT01939899|EG000|Reported Event|Lead-in Dose Finding Phase: Ixazomib 4 mg|Ixazomib 4 milligram (mg), solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or progressive disease (PD) or the start of alternate therapies during lead-in dose finding in non-hodgkin lymphoma (NHL) participants.
11160335|NCT01939899|EG001|Reported Event|Lead-in Dose Finding Phase: Ixazomib 5.3 mg|Ixazomib 5.3 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160336|NCT01939899|EG002|Reported Event|Lead-in Dose Finding Phase: Ixazomib 7.0 mg|Ixazomib 7 mg, solution, orally, once on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during lead-in dose finding in NHL participants.
11160337|NCT01939899|EG003|Reported Event|Phase 2: PSMB1 Positive|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in relapsed Or refractory follicular lymphoma (RRFL) participants.
11160338|NCT01939899|EG004|Reported Event|Phase 2: PSMB1 Negative|Ixazomib RP2D mg, solution, orally, once weekly on Day 1, 8, and 15 followed by 13 days of rest in a 28-days treatment cycle for a maximum of 29 cycles, or PD or the start of alternate therapies during phase 2 finding in RRFL participants.
11160339|NCT01939938|BG000|Baseline|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
11160340|NCT01939938|FG000|Participant Flow|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
11160341|NCT01939938|OG000|Outcome|Baseline AHI|AHI at baseline.
11160342|NCT01939938|OG001|Outcome|Residual AHI|AHI residual.
11173943|NCT02018887|OG015|Outcome|Cohort 8A - 40 mg LY2969822 BID Titrated|Up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, and 40 mg BID for 8 days.)
11160343|NCT01939938|OG000|Outcome|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
11160344|NCT01939938|EG000|Reported Event|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
11160345|NCT01939977|BG000|Baseline|Paricalcitol|"Paricalcitol oral capsules.~Paricalcitol: 1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours."
11160346|NCT01939977|BG001|Baseline|Calcifediol|"Calcifediol oral drops.~Calcifediol: 5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment."
11160347|NCT01939977|BG002|Baseline|Total|Total of all reporting groups
11160348|NCT01939977|FG000|Participant Flow|Paricalcitol|"Paricalcitol oral capsules.~Paricalcitol: 1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours."
11160349|NCT01939977|FG001|Participant Flow|Calcifediol|"Calcifediol oral drops.~Calcifediol: 5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment."
11160350|NCT01939977|OG000|Outcome|Paricalcitol|"Paricalcitol oral capsules.~Paricalcitol: 1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours."
11160351|NCT01939977|OG001|Outcome|Calcifediol|"Calcifediol oral drops.~Calcifediol: 5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment."
11160352|NCT01939977|EG000|Reported Event|Paricalcitol|"Paricalcitol oral capsules.~Paricalcitol: 1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours."
11160353|NCT01939977|EG001|Reported Event|Calcifediol|"Calcifediol oral drops.~Calcifediol: 5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment."
11160354|NCT01940120|BG000|Baseline|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
11160355|NCT01940120|FG000|Participant Flow|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
11160356|NCT01940120|OG000|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
11160357|NCT01940120|OG000|Outcome|High Risk Registry Arm|"Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.~."
11160358|NCT01940120|EG000|Reported Event|High Risk Registry Arm|"Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.~Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve"
11160359|NCT01940146|BG000|Baseline|SPARC Placebo|Baseline characteristics: Age
11160360|NCT01940146|BG001|Baseline|SPARC1310 I|Baseline characteristics: Age
11160361|NCT01940146|BG002|Baseline|SPARC1310 II|S0597 mid dose: S0597 mid dose
11160362|NCT01940146|BG003|Baseline|SPARC1310 III|S0597 high dose: S0597 high dose
11160363|NCT01940146|BG004|Baseline|Total|Total of all reporting groups
11160364|NCT01940146|FG000|Participant Flow|SPARC Placebo|SPARC Placebo was administered as sprays/nostril QD
11160365|NCT01940146|FG001|Participant Flow|SPARC1310 I|SPARC1310 I was administered as two sprays /nostril QD
11160366|NCT01940146|FG002|Participant Flow|SPARC1310 II|SPARC1310 II was administered as two sprays/nostril QD
11160367|NCT01940146|FG003|Participant Flow|SPARC1310 III|SPARC1310 III was administered as two sprays/nostril QD
11160368|NCT01940146|OG000|Outcome|Placebo|Placebo: Placebo
11160369|NCT01940146|OG001|Outcome|S0597 Low Dose|S0597 low dose: S0597 low dose
11160370|NCT01940146|OG002|Outcome|S0597 Mid Dose|S0597 mid dose: S0597 mid dose
11160371|NCT01940146|OG003|Outcome|S0597 High Dose|S0597 high dose: S0597 high dose
11160372|NCT01940146|EG000|Reported Event|SPARC Placebo|SPARC Placebo administration
11160373|NCT01940146|EG001|Reported Event|SPARC1310 I|SPARC1310 I administration
11160374|NCT01940146|EG002|Reported Event|SPARC1310 II|SPARC1310 II administration
11160375|NCT01940146|EG003|Reported Event|SPARC1310 III|SPARC1310 III administration
11160376|NCT01940276|BG000|Baseline|White|Patients self identifying as white who received the study regimen
11160377|NCT01940276|BG001|Baseline|Black|Patients self identifying as black who received the study regimen
11160378|NCT01940276|BG002|Baseline|Total|Total of all reporting groups
11160379|NCT01940276|FG000|Participant Flow|Abiraterone Acetate and Prednisone: White Men|Patients self identifying as white men who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
11160380|NCT01940276|FG001|Participant Flow|Abiraterone Acetate and Prednisone: African American Men|Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
11160381|NCT01940276|OG000|Outcome|Abiraterone Acetate and Prednisone: White Men|Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
11160382|NCT01940276|OG001|Outcome|Abiraterone Acetate and Prednisone: African American Men|Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
11160383|NCT01940276|EG000|Reported Event|Abiraterone Acetate and Prednisone: White Men|Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
11160384|NCT01940276|EG001|Reported Event|Abiraterone Acetate and Prednisone: African American Men|Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
11160385|NCT01940354|BG000|Baseline|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
11160386|NCT01940354|BG001|Baseline|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples"
11160387|NCT01940354|BG002|Baseline|Total|Total of all reporting groups
11160388|NCT01940354|FG000|Participant Flow|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
11160389|NCT01940354|FG001|Participant Flow|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples"
11160390|NCT01940354|OG000|Outcome|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
11160391|NCT01940354|OG001|Outcome|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples"
11160392|NCT01940354|EG000|Reported Event|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
11160393|NCT01940354|EG001|Reported Event|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
11160394|NCT01940484|BG000|Baseline|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
11160395|NCT01940484|FG000|Participant Flow|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta (Mircera) as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
11160396|NCT01940484|OG000|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
11160397|NCT01940484|EG000|Reported Event|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
11160398|NCT01940497|BG000|Baseline|Trastuzumab (Vial)|Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160399|NCT01940497|BG001|Baseline|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160400|NCT01940497|BG002|Baseline|Total|Total of all reporting groups
11160401|NCT01940497|FG000|Participant Flow|Trastuzumab (Vial)|Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160402|NCT01940497|FG001|Participant Flow|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160403|NCT01940497|OG000|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160404|NCT01940497|OG001|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160405|NCT01940497|OG002|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160406|NCT01940497|OG003|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160407|NCT01940497|OG000|Outcome|Trastuzumab (Vial)|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160408|NCT01940497|OG001|Outcome|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160409|NCT01940497|OG000|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160410|NCT01940497|OG001|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160411|NCT01940497|OG000|Outcome|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160412|NCT01940497|OG000|Outcome|HCPs: Trastuzumab (Vial)|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). Trastuzumab using vial had to be administered by an HCP.
11160413|NCT01940497|OG001|Outcome|HCPs: Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). Trastuzumab using SID had to be administered by an HCP or by the participant after appropriate training and under HCP supervision.
11160414|NCT01940497|EG000|Reported Event|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160415|NCT01940497|EG001|Reported Event|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160416|NCT01940497|EG002|Reported Event|Trastuzumab (SID) Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160417|NCT01940497|EG003|Reported Event|Trastuzumab (SID) Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
11160418|NCT01940510|BG000|Baseline|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally alone on Day 1 (Period 1), with rifampin (600 mg capsules orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
11160419|NCT01940510|FG000|Participant Flow|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib (RO5424802) 600 milligram (mg) capsules (four 150 mg capsules) orally alone on Day 1 (Period 1), with rifampin (600 mg capsules [two 300 mg capsules] orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
11160420|NCT01940510|OG000|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
11160421|NCT01940510|OG001|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
11160422|NCT01940510|EG000|Reported Event|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
11160423|NCT01940510|EG001|Reported Event|Treatment Period 2: Rifampin|Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 8 through 16.
11160424|NCT01940510|EG002|Reported Event|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
11160425|NCT01940523|BG000|Baseline|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
11160426|NCT01940523|BG001|Baseline|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
11160427|NCT01940523|BG002|Baseline|Total|Total of all reporting groups
11160428|NCT01940523|FG000|Participant Flow|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. Tourniquet will be released.~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m)."
11160429|NCT01940523|FG001|Participant Flow|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
11160430|NCT01940523|OG000|Outcome|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
11160431|NCT01940523|OG001|Outcome|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
11160432|NCT01940523|OG000|Outcome|IV TXA Group|Kaitlin - Explain this group....
11160433|NCT01940523|OG001|Outcome|Topical TXA Group|Kaitlin - Explain this group
11160434|NCT01940523|EG000|Reported Event|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
11160435|NCT01940523|EG001|Reported Event|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
11160436|NCT01940705|BG000|Baseline|Standard of Care|"standard of care hearing-aid orientation as provided by clinical audiologist~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160437|NCT01940705|BG001|Baseline|SoC Plus Hearing-aid Informational Guide|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids~Hearing-Aid Informational Guide: Printed take-home guide on hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160438|NCT01940705|BG002|Baseline|SoC Plus a Take-home DVD|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids~Hearing-Aid DVD: Take-home DVD about hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160439|NCT01940705|BG003|Baseline|SoC Plus Counseling With the Teach-back Technique|"standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids~Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160440|NCT01940705|BG004|Baseline|Total|Total of all reporting groups
11160441|NCT01940705|FG000|Participant Flow|Standard of Care|"standard of care hearing-aid orientation as provided by clinical audiologist~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160442|NCT01940705|FG001|Participant Flow|Standard of Care Plus Hearing-aid Informational Guide|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids~Hearing-Aid Informational Guide: Printed take-home guide on hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160443|NCT01940705|FG002|Participant Flow|Standard of Care Plus a Take-home Digital Video Disc|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home digital video disc regarding hearing aids~Hearing-Aid digital video disc : Take-home digital video disc about hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160444|NCT01940705|FG003|Participant Flow|Standard of Care Plus Counseling With the Teach-back Technique|"standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids~Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160445|NCT01940705|OG000|Outcome|Standard of Care|"standard of care hearing-aid orientation as provided by clinical audiologist~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160446|NCT01940705|OG001|Outcome|Standard of Care Plus Hearing-aid Informational Guide|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids~Hearing-Aid Informational Guide: Printed take-home guide on hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160447|NCT01940705|OG002|Outcome|Standard of Care Plus a Take-home Digital Video Disc|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids~Hearing-Aid digital video disc: Take-home digital video disc about hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160448|NCT01940705|OG003|Outcome|Standard of Care Plus Counseling With the Teach-back Technique|"standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids~Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160449|NCT01940705|OG001|Outcome|SoC Plus Hearing-aid Informational Guide|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids~Hearing-Aid Informational Guide: Printed take-home guide on hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160450|NCT01940705|OG002|Outcome|SoC Plus a Take-home DVD|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids~Hearing-Aid DVD: Take-home DVD about hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160451|NCT01940705|OG003|Outcome|SoC Plus Counseling With the Teach-back Technique|"standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids~Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160452|NCT01940705|EG000|Reported Event|Standard of Care|"standard of care hearing-aid orientation as provided by clinical audiologist~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160453|NCT01940705|EG001|Reported Event|SoC Plus Hearing-aid Informational Guide|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids~Hearing-Aid Informational Guide: Printed take-home guide on hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160454|NCT01940705|EG002|Reported Event|SoC Plus a Take-home DVD|"standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids~Hearing-Aid DVD: Take-home DVD about hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160455|NCT01940705|EG003|Reported Event|SoC Plus Counseling With the Teach-back Technique|"standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids~Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids~Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist"
11160456|NCT01940887|BG000|Baseline|E10030 + Bevacizumab or Aflibercept|"E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~E10030~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept"
11160457|NCT01940887|BG001|Baseline|Sham + Bevacizumab or Aflibercept|"E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept~E10030 sham injection: Pressure on the eye with a syringe with no needle"
11160458|NCT01940887|BG002|Baseline|Total|Total of all reporting groups
11160459|NCT01940887|FG000|Participant Flow|E10030 + Bevacizumab or Aflibercept|"E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~E10030~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept"
11160460|NCT01940887|FG001|Participant Flow|Sham + Bevacizumab or Aflibercept|"E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept~E10030 sham injection: Pressure on the eye with a syringe with no needle"
11160461|NCT01940887|OG000|Outcome|E10030 + Bevacizumab or Aflibercept|"E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~E10030~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept"
11160462|NCT01940887|OG001|Outcome|Sham + Bevacizumab or Aflibercept|"E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept~E10030 sham injection: Pressure on the eye with a syringe with no needle"
11160463|NCT01940887|EG000|Reported Event|E10030 + Bevacizumab or Aflibercept|"E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~E10030~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept"
11160464|NCT01940887|EG001|Reported Event|Sham + Bevacizumab or Aflibercept|"E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept~E10030 sham injection: Pressure on the eye with a syringe with no needle"
11160465|NCT01940900|BG000|Baseline|E10030 + Ranibizumab|"E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection~E10030~ranibizumab"
11160466|NCT01940900|BG001|Baseline|Sham + Ranibizumab|"E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection~ranibizumab~E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle"
11160467|NCT01940900|BG002|Baseline|Total|Total of all reporting groups
11160468|NCT01940900|FG000|Participant Flow|E10030 + Ranibizumab|"E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection~E10030~ranibizumab"
11160469|NCT01940900|FG001|Participant Flow|Sham + Ranibizumab|"E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection~ranibizumab~E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle"
11160470|NCT01940900|OG000|Outcome|E10030 + Ranibizumab|"E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection~E10030~ranibizumab"
11160471|NCT01940900|OG001|Outcome|Sham + Ranibizumab|"E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection~ranibizumab~E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle"
11160472|NCT01940900|EG000|Reported Event|E10030 + Ranibizumab|"E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection~E10030~ranibizumab"
11160473|NCT01940900|EG001|Reported Event|Sham + Ranibizumab|"E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection~ranibizumab~E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle"
11160474|NCT01940939|BG000|Baseline|Active rTMS|"Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100."
11160475|NCT01940939|BG001|Baseline|Sham rTMS|"Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.~Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100."
11160476|NCT01940939|BG002|Baseline|Total|Total of all reporting groups
11160477|NCT01940939|FG000|Participant Flow|Active rTMS|"Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100."
11160478|NCT01940939|FG001|Participant Flow|Sham rTMS|"Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.~Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100."
11160479|NCT01940939|OG000|Outcome|Active rTMS|"Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100."
11173944|NCT02018887|OG016|Outcome|Cohort 8B - 20 mg LY2969822 BID Titrated|Up to 20 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, and 20 mg BID for 10 days.
11173945|NCT02018887|OG000|Outcome|Cohort 1 - 2 mg LY2969822|2 mg LY2969822 administered once, PO.
11173946|NCT02018887|OG001|Outcome|Cohort 1 - 20 mg LY2969822|20 mg LY2969822 administered once, PO.
11160480|NCT01940939|OG001|Outcome|Sham rTMS|"Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.~Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100."
11160481|NCT01940939|EG000|Reported Event|Sham rTMS|"3 subjects reported a transient headache in the initial period, After giving comfort the symptoms were significantly reduced.~No other adverse events were observed."
11160482|NCT01940939|EG001|Reported Event|Active rTMS|"4 subjects reported a transient headache and 1 subjects reported dizziness in the initial period.After giving comfort and reducing initial intensity of stimulation, the symptoms were significantly reduced.~No other adverse events were observed."
11160483|NCT01941030|BG000|Baseline|Orbital Atherectomy System|Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA) Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA) Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
11160484|NCT01941030|BG001|Baseline|Balloon Angioplasty|Balloon Angioplasty (BA) alone Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
11160485|NCT01941030|BG002|Baseline|Total|Total of all reporting groups
11160486|NCT01941030|FG000|Participant Flow|Orbital Atherectomy System|"Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)~Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)~Balloon Angioplasty: Type of balloon selected is driven by preference of the operator."
11160487|NCT01941030|FG001|Participant Flow|Balloon Angioplasty|"Balloon Angioplasty (BA) alone~Balloon Angioplasty: Type of balloon selected is driven by preference of the operator."
11160488|NCT01941030|OG000|Outcome|Orbital Atherectomy System|"Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)~Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)~Balloon Angioplasty: Type of balloon selected is driven by preference of the operator."
11160489|NCT01941030|OG001|Outcome|Balloon Angioplasty|"Balloon Angioplasty (BA) alone~Balloon Angioplasty: Type of balloon selected is driven by preference of the operator."
11160490|NCT01941030|EG000|Reported Event|Orbital Atherectomy System|"Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)~Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)~Balloon Angioplasty: Type of balloon selected is driven by preference of the operator."
11160491|NCT01941030|EG001|Reported Event|Balloon Angioplasty|"Balloon Angioplasty (BA) alone~Balloon Angioplasty: Type of balloon selected is driven by preference of the operator."
11160492|NCT01941095|BG000|Baseline|Tocilizumab|Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
11160493|NCT01941095|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 162 milligrams (mg) subcutaneous (SC) injection once a week (QW) either as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
11160494|NCT01941095|OG000|Outcome|Tocilizumab|Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
11160495|NCT01941095|EG000|Reported Event|Tocilizumab Monotherapy|Participants received tocilizumab 162 mg SC injection QW as monotherapy during the treatment period of 52 weeks.
11160496|NCT01941095|EG001|Reported Event|Tocilizumab + Methotrexate or Other Non-Biologic DMARDs|Participants received tocilizumab 162 mg SC injection QW in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks.
11160497|NCT01941186|BG000|Baseline|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
11160498|NCT01941186|BG001|Baseline|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
11160499|NCT01941186|BG002|Baseline|Total|Total of all reporting groups
11160500|NCT01941186|FG000|Participant Flow|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
11160501|NCT01941186|FG001|Participant Flow|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
11173947|NCT02018887|OG002|Outcome|Cohort 1 - 40 mg LY2969822|40 mg LY2969822 administered once, PO.
11173948|NCT02018887|OG003|Outcome|Cohort 2 - 6 mg LY2969822|6 mg LY2969822 administered once, PO.
11160502|NCT01941186|OG000|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
11160503|NCT01941186|OG001|Outcome|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
11160504|NCT01941186|OG000|Outcome|Patient Decision Aid: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
11160505|NCT01941186|OG001|Outcome|Patient Decision Aid: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
11160506|NCT01941186|OG002|Outcome|Patient Decision Aid: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post"
11160507|NCT01941186|OG003|Outcome|Patient Decision Aid: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention"
11160508|NCT01941186|OG004|Outcome|Patient Decision Aid: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
11160509|NCT01941186|OG005|Outcome|Patient Decision Aid: Strongly Agree|"Percentage of parents who answered Strongly Agree to questions during pre and post intervention"
11160510|NCT01941186|OG006|Outcome|Routine Care: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
11160511|NCT01941186|OG007|Outcome|Routine Care: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
11160512|NCT01941186|OG008|Outcome|Routine Care: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post intervention"
11160513|NCT01941186|OG009|Outcome|Routine Care: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention."
11160514|NCT01941186|OG010|Outcome|Routine Care: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
11160515|NCT01941186|OG011|Outcome|Routine Care: Strongly Agree|"Percentage of parents who answered strongly agree to questions during pre and post intervention"
11160516|NCT01941186|OG001|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
11160517|NCT01941186|EG000|Reported Event|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
11160518|NCT01941186|EG001|Reported Event|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
11160519|NCT01941472|BG000|Baseline|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
11160520|NCT01941472|FG000|Participant Flow|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
11160521|NCT01941472|OG000|Outcome|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
11160522|NCT01941472|EG000|Reported Event|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
11160523|NCT01941485|BG000|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
11160524|NCT01941485|FG000|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
11160525|NCT01941485|OG000|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
11160526|NCT01941485|OG000|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
11160527|NCT01941485|OG001|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
11160528|NCT01941485|OG002|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
11160529|NCT01941485|OG003|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
11160530|NCT01941485|OG004|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
11160531|NCT01941485|OG005|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
11160532|NCT01941485|OG001|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
11160533|NCT01941485|OG002|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
11160534|NCT01941485|OG003|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
11160535|NCT01941485|OG004|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
11160536|NCT01941485|OG000|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
11160537|NCT01941485|OG002|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
11160538|NCT01941485|OG003|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
11160539|NCT01941485|OG000|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal flap creation
11160540|NCT01941485|OG000|Outcome|Q-Value|WaveLight Refractive Suite
11160541|NCT01941485|OG000|Outcome|AC Volume|WaveLight Refractive Suite
11160542|NCT01941485|OG000|Outcome|AC Depth|WaveLight Refractive Suite
11160543|NCT01941485|OG000|Outcome|Angles|WaveLight Refractive Suite
11160544|NCT01941485|EG000|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
11160545|NCT01941498|BG000|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
11160546|NCT01941498|FG000|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
11160547|NCT01941498|OG000|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
11160548|NCT01941498|OG000|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
11160549|NCT01941498|OG001|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
11160550|NCT01941498|OG002|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
11160551|NCT01941498|OG000|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
11160552|NCT01941498|OG001|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
11160553|NCT01941498|OG002|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
11160554|NCT01941498|OG003|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
11160555|NCT01941498|OG004|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
11160556|NCT01941498|OG002|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
11160557|NCT01941498|OG003|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
11160558|NCT01941498|OG000|Outcome|EX500 Laser|Excimer 500 laser used during LASIK surgery for corneal ablation
11160559|NCT01941498|OG001|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal ablation
11160560|NCT01941498|OG000|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
11160561|NCT01941498|OG001|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
11160562|NCT01941498|EG000|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
11160563|NCT01941498|EG001|Reported Event|Screen Failure|Prior to treatment
11160564|NCT01941537|BG000|Baseline|ILV-094|"Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).~ILV-094: IV infusion of ILV-094"
11160565|NCT01941537|BG001|Baseline|Placebo Comparator|"Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).~Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10)."
11160566|NCT01941537|BG002|Baseline|Total|Total of all reporting groups
11160567|NCT01941537|FG000|Participant Flow|ILV-094|"Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).~ILV-094: IV infusion of ILV-094"
11160568|NCT01941537|FG001|Participant Flow|Placebo Comparator|"Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).~Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10)."
11160569|NCT01941537|OG000|Outcome|ILV-094|Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).
11160570|NCT01941537|OG001|Outcome|Placebo Comparator|"Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).~Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10)."
11160571|NCT01941537|OG000|Outcome|ILV-094|"Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).~ILV-094: IV infusion of ILV-094"
11160572|NCT01941537|EG000|Reported Event|ILV-094|Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).
11160573|NCT01941537|EG001|Reported Event|Placebo Comparator|"Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).~Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10)."
11160574|NCT01941628|BG000|Baseline|Rocuronium|Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.
11160575|NCT01941628|BG001|Baseline|Succinylcholine|Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
11160576|NCT01941628|BG002|Baseline|Total|Total of all reporting groups
11160577|NCT01941628|FG000|Participant Flow|Rocuronium|Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.
11160578|NCT01941628|FG001|Participant Flow|Succinylcholine|Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
11160579|NCT01941628|OG000|Outcome|Rocuronium|Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.
11160580|NCT01941628|OG001|Outcome|Succinylcholine|Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
11160581|NCT01941628|EG000|Reported Event|Rocuronium|Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.
11160582|NCT01941628|EG001|Reported Event|Succinylcholine|Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
11160583|NCT01941745|BG000|Baseline|Placebo (Associated w/ Low Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 22 participants"
11160584|NCT01941745|BG001|Baseline|Low Dose (rhCC10)|"Dosage: 1.5 mg/kg study drug rhCC10 in 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 22 participants"
11160585|NCT01941745|BG002|Baseline|Placebo (Associated w/ High Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 23 participants"
11160586|NCT01941745|BG003|Baseline|High Dose (rhCC10)|"Dosage: 5 mg/kg of rhCC10 given in 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 23 participants"
11160587|NCT01941745|BG004|Baseline|Total|Total of all reporting groups
11160588|NCT01941745|FG000|Participant Flow|Placebo (Associated w/ Low Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 22 participants"
11160589|NCT01941745|FG001|Participant Flow|Low Dose (rhCC10)|"Dosage: 1.5 mg/kg study drug rhCC10 in 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 22 participants"
11160590|NCT01941745|FG002|Participant Flow|Placebo (Associated w/ High Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 21 participants"
11160591|NCT01941745|FG003|Participant Flow|High Dose (rhCC10)|"Dosage: 5 mg/kg of rhCC10 given in 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 23 participants"
11160592|NCT01941745|OG000|Outcome|Placebo (Associated w/ Low Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 22 participants"
11160593|NCT01941745|OG001|Outcome|Low Dose (rhCC10)|"Dosage: 1.5 mg/kg study drug rhCC10 in 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 22 participants"
11160594|NCT01941745|OG002|Outcome|Placebo (Associated w/ High Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 21 participants"
11160595|NCT01941745|OG003|Outcome|High Dose (rhCC10)|"Dosage: 5 mg/kg of rhCC10 given in 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 23 participants"
11160596|NCT01941745|OG002|Outcome|Placebo (Associated w/ High Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 23 participants"
11160597|NCT01941745|OG001|Outcome|Low Dose rhCC10|"1.5 mg/kg study drug (rhCC10)in 2 ml/kg given intratracheally times one dose~Low Dose rhCC10: 1.5 mg/kg study drug (rhCC10)"
11160598|NCT01941745|OG003|Outcome|High Dose rhCC10|"5 mg/kg of rhCC10 given in 2 ml/kg and administered intratracheally times one dose~High dose rhCC10: 5 mg/kg in 2 ml/kg"
11160599|NCT01941745|EG000|Reported Event|Placebo (Associated w/ Low Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 22 participants"
11160600|NCT01941745|EG001|Reported Event|Low Dose (rhCC10)|"Dosage: 1.5 mg/kg study drug rhCC10 in 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 22 participants"
11160601|NCT01941745|EG002|Reported Event|Placebo (Associated w/ High Dose Cohort)|"Dosage: Single dose of half normal saline at 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 21 participants"
11160602|NCT01941745|EG003|Reported Event|High Dose (rhCC10)|"Dosage: 5 mg/kg of rhCC10 given in 2 ml/kg~Administration: once intratracheally within the first 24 hours of life, and once within 4 hours of the first dose of exogenous surfactant (CurosurfTM)~Enrollment: 23 participants"
11160603|NCT01941927|BG000|Baseline|NRAS Wildtype|Patients without NRAS exon 1 and 2 mutations
11160604|NCT01941927|BG001|Baseline|NRAS Mutant|Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
11160605|NCT01941927|BG002|Baseline|Total|Total of all reporting groups
11160606|NCT01941927|FG000|Participant Flow|NRAS Wildtype|Patients without NRAS (neuroblastoma RAS viral oncogene homolog) exon 1 and 2 mutations
11160607|NCT01941927|FG001|Participant Flow|NRAS Mutant|Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
11160608|NCT01941927|OG000|Outcome|NRAS Wildtype|Patients without NRAS exon 1 and 2 mutations
11160609|NCT01941927|OG001|Outcome|NRAS Mutant|Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
11160610|NCT01941927|OG000|Outcome|Trametinib, GSK2141795|"Trametinib (GSK1120212)~Oral~2 mg~Daily~Number of Cycles: until progression or unacceptable toxicity develops~GSK2141795~Oral~25 mg~Daily~Number of Cycles: until progression or unacceptable toxicity develops"
11160611|NCT01941927|EG000|Reported Event|Trametinib, GSK2141795|"Trametinib (GSK1120212)~Oral, 2 mg Daily~Number of Cycles: until progression or unacceptable toxicity develops~GSK2141795~Oral, 25 mg Daily~Number of Cycles: until progression or unacceptable toxicity develops"
11160612|NCT01941940|BG000|Baseline|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
11160613|NCT01941940|FG000|Participant Flow|Tocilizumab|Tocilizumab at a fixed dose of 162 milligrams (mg) was administered as subcutaneous (SC) injection alone or along with methotrexate and/or other non-biological Disease-Modifying Antirheumatic Drugs (DMARDs) irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
11160614|NCT01941940|OG000|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
11160615|NCT01941940|EG000|Reported Event|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
11160616|NCT01942148|BG000|Baseline|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
11160617|NCT01942148|FG000|Participant Flow|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
11160618|NCT01942148|OG000|Outcome|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
11160619|NCT01942148|EG000|Reported Event|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
11160620|NCT01942161|BG000|Baseline|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
11160621|NCT01942161|BG001|Baseline|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
11160622|NCT01942161|BG002|Baseline|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
11160623|NCT01942161|BG003|Baseline|Total|Total of all reporting groups
11160624|NCT01942161|FG000|Participant Flow|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
11160625|NCT01942161|FG001|Participant Flow|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
11160626|NCT01942161|FG002|Participant Flow|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
11160627|NCT01942161|OG000|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
11173949|NCT02018887|OG004|Outcome|Cohort 2 - 60 mg LY2969822|60 mg LY2969822 administered once, PO.
11173950|NCT02018887|OG005|Outcome|Cohort 2 - 20 mg LY2969822|20 mg LY2969822 administered once, PO.
11173951|NCT02018887|OG006|Outcome|Cohort 3 - 20 mg LY2969822 QD Day 1 (Fasted)|20 mg LY2969822 administered QD, PO, for 14 days.
11160628|NCT01942161|OG001|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
11160629|NCT01942161|OG002|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
11160630|NCT01942161|EG000|Reported Event|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
11160631|NCT01942161|EG001|Reported Event|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
11160632|NCT01942161|EG002|Reported Event|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
11160633|NCT01942486|BG000|Baseline|Investigational Coating|Investigational Coating
11160634|NCT01942486|FG000|Participant Flow|Investigational Coating|Subjects will be randomized to wear an investigational coating on their glasses
11160635|NCT01942486|OG000|Outcome|Investigational Coating|Subjects will wear an investigational coating on their eyeglasses to reduce headache frequency
11160636|NCT01942486|EG000|Reported Event|Investigational Coating|Subjects were asked to wear an investigational coating on their eyeglasses to reduce their headache severity
11160637|NCT01942590|BG000|Baseline|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
11160638|NCT01942590|BG001|Baseline|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
11160639|NCT01942590|BG002|Baseline|Total|Total of all reporting groups
11160640|NCT01942590|FG000|Participant Flow|Clenbuterol|"Initially, 40 mcg each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
11160641|NCT01942590|FG001|Participant Flow|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
11160642|NCT01942590|OG000|Outcome|Clenbuterol|"Initially, 40 mcg each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
11160643|NCT01942590|OG001|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
11160644|NCT01942590|OG000|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
11160645|NCT01942590|EG000|Reported Event|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
11160646|NCT01942590|EG001|Reported Event|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
11160647|NCT01942668|BG000|Baseline|Combined Estradiol 1 mg / Progesterone 100 mg|Combined Estradiol 1 mg / Progesterone 100 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160648|NCT01942668|BG001|Baseline|Combined Estradiol 0.5 mg / Progesterone 100 mg|Combined Estradiol 0.5 mg / Progesterone 100 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160649|NCT01942668|BG002|Baseline|Combined Estradiol 0.5 mg / Progesterone 50 mg|Combined Estradiol 0.5 mg / Progesterone 50 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160650|NCT01942668|BG003|Baseline|Combined Estradiol 0.25 mg / Progesterone 50 mg|Combined Estradiol 0.25 mg / Progesterone 50 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160651|NCT01942668|BG004|Baseline|Placebo|Two Placebo softgel capsules taken orally once a day for twelve months.
11160652|NCT01942668|BG005|Baseline|Total|Total of all reporting groups
11160653|NCT01942668|FG000|Participant Flow|Combined Estradiol 1 mg / Progesterone 100 mg|Combined Estradiol 1 mg / Progesterone 100 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160654|NCT01942668|FG001|Participant Flow|Combined Estradiol 0.5 mg / Progesterone 100 mg|Combined Estradiol 0.5 mg / Progesterone 100 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160655|NCT01942668|FG002|Participant Flow|Combined Estradiol 0.5 mg / Progesterone 50 mg|Combined Estradiol 0.5 mg / Progesterone 50 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160656|NCT01942668|FG003|Participant Flow|Combined Estradiol 0.25 mg / Progesterone 50 mg|Combined Estradiol 0.25 mg / Progesterone 50 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160657|NCT01942668|FG004|Participant Flow|Placebo|Two Placebo softgel capsules taken orally once a day for twelve months.
11160658|NCT01942668|OG000|Outcome|Combined Estradiol 1 mg / Progesterone 100 mg|Combined Estradiol 1 mg / Progesterone 100 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160659|NCT01942668|OG001|Outcome|Combined Estradiol 0.5 mg / Progesterone 100 mg|Combined Estradiol 0.5 mg / Progesterone 100 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160660|NCT01942668|OG002|Outcome|Combined Estradiol 0.5 mg / Progesterone 50 mg|Combined Estradiol 0.5 mg / Progesterone 50 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160661|NCT01942668|OG003|Outcome|Combined Estradiol 0.25 mg / Progesterone 50 mg|Combined Estradiol 0.25 mg / Progesterone 50 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160662|NCT01942668|OG004|Outcome|Placebo|Two Placebo softgel capsules taken orally once a day for twelve months.
11160663|NCT01942668|OG000|Outcome|Combined Estradiol 1 mg / Progesterone 100 mg|Combined Estradiol 1 mg / Progesterone 100 mg formulation taken orally once a day for twelve months.
11160664|NCT01942668|OG001|Outcome|Combined Estradiol 0.5 mg / Progesterone 100 mg|Combined Estradiol 0.5 mg / Progesterone 100 mg formulation taken orally once a day for twelve months.
11160665|NCT01942668|OG002|Outcome|Combined Estradiol 0.5 mg / Progesterone 50 mg|Combined Estradiol 0.5 mg / Progesterone 50 mg formulation taken orally once a day for twelve months.
11160666|NCT01942668|OG003|Outcome|Combined Estradiol 0.25 mg / Progesterone 50 mg|Combined Estradiol 0.25 mg / Progesterone 50 mg formulation taken orally once a day for twelve months.
11160667|NCT01942668|OG004|Outcome|Placebo|Two Placebo capsules taken orally once a day for twelve months.
11160668|NCT01942668|EG000|Reported Event|Combined Estradiol 1 mg / Progesterone 100 mg|Combined Estradiol 1 mg / Progesterone 100 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160669|NCT01942668|EG001|Reported Event|Combined Estradiol 0.5 mg / Progesterone 100 mg|Combined Estradiol 0.5 mg / Progesterone 100 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160670|NCT01942668|EG002|Reported Event|Combined Estradiol 0.5 mg / Progesterone 50 mg|Combined Estradiol 0.5 mg / Progesterone 50 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160671|NCT01942668|EG003|Reported Event|Combined Estradiol 0.25 mg / Progesterone 50 mg|Combined Estradiol 0.25 mg / Progesterone 50 mg formulation and placebo softgel capsules taken orally once a day for twelve months.
11160672|NCT01942668|EG004|Reported Event|Placebo|Two Placebo softgel capsules taken orally once a day for twelve months.
11160673|NCT01942694|BG000|Baseline|Placebo|"One pill daily~Placebo: Administered as one soft-gel pill daily by mouth"
11160674|NCT01942694|BG001|Baseline|Vitamin D (Cholecalciferol)|"One vitamin D pill daily~Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth."
11160675|NCT01942694|BG002|Baseline|Total|Total of all reporting groups
11160676|NCT01942694|FG000|Participant Flow|Placebo|"One pill daily~Placebo: Administered as one soft-gel pill daily by mouth"
11160677|NCT01942694|FG001|Participant Flow|Vitamin D (Cholecalciferol)|"One vitamin D pill daily~Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth."
11160678|NCT01942694|OG000|Outcome|Placebo|"One pill daily~Placebo: Administered as one soft-gel pill daily by mouth"
11160679|NCT01942694|OG001|Outcome|Vitamin D (Cholecalciferol)|"One vitamin D pill daily~Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth."
11160680|NCT01942694|EG000|Reported Event|Placebo|"One pill daily~Placebo: Administered as one soft-gel pill daily by mouth"
11160681|NCT01942694|EG001|Reported Event|Vitamin D (Cholecalciferol)|"One vitamin D pill daily~Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth."
11160682|NCT01942707|BG000|Baseline|No Keeping Scarpa's Fascia|"Abdominoplasty in anchor-line without keeping Scarpa's Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
11160683|NCT01942707|BG001|Baseline|Keeping Scarpa's Fascia|"Abdominoplasty in anchor-line keeping Scarpa's Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
11160684|NCT01942707|BG002|Baseline|Total|Total of all reporting groups
11160685|NCT01942707|FG000|Participant Flow|Anchor-line Abdominoplasty Without Scarpa's Fascia|Anchor-line abdominoplasty. The Scarpa's Fascia will be removed in this group.
11160686|NCT01942707|FG001|Participant Flow|Anchor-line Abdominoplasty With Scarpa's Fascia|Anchor-line abdominoplasty. In this group the Scarpa's Fascia will be preserved.
11160687|NCT01942707|OG000|Outcome|Without Scarpa's Fascia|"Abdominoplasty in anchor-line without keeping Scarpa's Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
11160688|NCT01942707|OG001|Outcome|With Scarpa's Fascia|"Abdominoplasty in anchor-line keeping Scarpa's Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
11160689|NCT01942707|EG000|Reported Event|Anchor-line Abdominoplasty Without Scarpa's Fascia|Anchor-line Abdominoplasty where the Scarpa's Fascia will be removed.
11160690|NCT01942707|EG001|Reported Event|Anchor-line Abdominoplasty With Scarpa's Fascia|Anchor-line abdominoplasty where the Scarpa´s Fascia will be preserved.
11160691|NCT01942720|BG000|Baseline|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
11160692|NCT01942720|FG000|Participant Flow|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
11160693|NCT01942720|OG000|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
11160694|NCT01942720|EG000|Reported Event|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
11160695|NCT01942733|BG000|Baseline|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
11160696|NCT01942733|FG000|Participant Flow|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
11160697|NCT01942733|OG000|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
11160698|NCT01942733|EG000|Reported Event|Brexpiprazole|The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
11160699|NCT01942785|BG000|Baseline|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
11160700|NCT01942785|FG000|Participant Flow|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
11160701|NCT01942785|OG000|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
11160702|NCT01942785|OG000|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole:2-3 mg/day, once daily dose, tablets, for oral use"
11160703|NCT01942785|OG000|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
11160704|NCT01942785|EG000|Reported Event|Brexpiprazole|Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use
11160705|NCT01942993|BG000|Baseline|Vemurafenib|"960 mg (four tablets of 240 mg each) of vemurafenib PO BID~Vemurafenib: Vemurafenib will be administered at the FDA approved dose of 960 mg approximately 12 hours apart with or without a meal. Vemurafenib is provided at 240-mg film-coated tablets packed in bottles for oral administration. Vemurafenib should be swallowed whole with a glass of water and the medication should not be chewed or crushed. Management of symptomatic adverse events may require dose reductions, treatment interruptions, or treatment discontinuation. Dose reductions below 480 mg twice daily are not recommended."
11160706|NCT01942993|FG000|Participant Flow|Vemurafenib|"960 mg (four tablets of 240 mg each) of vemurafenib PO BID~Vemurafenib: Vemurafenib will be administered at the FDA approved dose of 960 mg approximately 12 hours apart with or without a meal. Vemurafenib is provided at 240-mg film-coated tablets packed in bottles for oral administration. Vemurafenib should be swallowed whole with a glass of water and the medication should not be chewed or crushed. Management of symptomatic adverse events may require dose reductions, treatment interruptions, or treatment discontinuation. Dose reductions below 480 mg twice daily are not recommended."
11160707|NCT01942993|OG000|Outcome|Vemurafenib|"960 mg (four tablets of 240 mg each) of vemurafenib PO BID~Vemurafenib: Vemurafenib will be administered at the FDA approved dose of 960 mg approximately 12 hours apart with or without a meal. Vemurafenib is provided at 240-mg film-coated tablets packed in bottles for oral administration. Vemurafenib should be swallowed whole with a glass of water and the medication should not be chewed or crushed. Management of symptomatic adverse events may require dose reductions, treatment interruptions, or treatment discontinuation. Dose reductions below 480 mg twice daily are not recommended."
11160708|NCT01942993|EG000|Reported Event|Vemurafenib|"960 mg (four tablets of 240 mg each) of vemurafenib PO BID~Vemurafenib: Vemurafenib will be administered at the FDA approved dose of 960 mg approximately 12 hours apart with or without a meal. Vemurafenib is provided at 240-mg film-coated tablets packed in bottles for oral administration. Vemurafenib should be swallowed whole with a glass of water and the medication should not be chewed or crushed. Management of symptomatic adverse events may require dose reductions, treatment interruptions, or treatment discontinuation. Dose reductions below 480 mg twice daily are not recommended."
11160709|NCT01943110|BG000|Baseline|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:~Upper deltoid with the side-load ID adapter~Upper deltoid with the AD ID adapter~Suprascapular (behind the shoulder) with the side-load ID adapter~Suprascapular with the AD ID adapter~Forearm with the side-load ID adapter~Forearm with the AD ID adapter~ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.~ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
11160710|NCT01943110|FG000|Participant Flow|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:~Upper deltoid with the side-load ID adapter~Upper deltoid with the AD ID adapter~Suprascapular (behind the shoulder) with the side-load ID adapter~Suprascapular with the AD ID adapter~Forearm with the side-load ID adapter~Forearm with the AD ID adapter~ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.~ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
11160711|NCT01943110|OG000|Outcome|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
11160712|NCT01943110|OG001|Outcome|ADID Forearm|Injections given with the autodisable ID adapter in the forearm
11160713|NCT01943110|OG002|Outcome|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
11160714|NCT01943110|OG003|Outcome|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
11160715|NCT01943110|OG004|Outcome|SLA Forearm|Injections given with the side-load ID adapter in the forearm
11160716|NCT01943110|OG005|Outcome|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
11160717|NCT01943110|OG000|Outcome|AD ID Adapter|Injections given with the autodisable ID adapter
11160718|NCT01943110|OG001|Outcome|SLA ID Adapter|Injections given with the side-load ID adapter
11160719|NCT01943110|EG000|Reported Event|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
11160720|NCT01943110|EG001|Reported Event|ADID Forearm|Injections given with the autodisable ID adapter in the forearm region
11160721|NCT01943110|EG002|Reported Event|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
11160722|NCT01943110|EG003|Reported Event|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
11160723|NCT01943110|EG004|Reported Event|SLA Forearm|Injections given with the side-load ID adapter in the forearm region
11160724|NCT01943110|EG005|Reported Event|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
11160725|NCT01943227|BG000|Baseline|Large Tidal Volume|Airway heat content
11160726|NCT01943227|BG001|Baseline|Small Tidal Volume|Airway heat content
11160727|NCT01943227|BG002|Baseline|Total|Total of all reporting groups
11160728|NCT01943227|FG000|Participant Flow|Large Tidal Volume|Change in airway heat content
11160729|NCT01943227|FG001|Participant Flow|Smal Tidal Volume|Change in airway heat content
11160730|NCT01943227|OG000|Outcome|Large Tidal Volume|Change in airway heat content
11160731|NCT01943227|OG001|Outcome|Smal Tidal Volume|Change in airway heat content
11160732|NCT01943227|EG000|Reported Event|Large Tidal Volume|Airway heat content
11160733|NCT01943227|EG001|Reported Event|Small Tidal Volume|Airway heat content
11160734|NCT01943292|BG000|Baseline|Defactinib 200 mg Bid|200 mg po bid defactinib
11160735|NCT01943292|BG001|Baseline|Defactinib 400 mg Bid|400 mg po bid defactinib
11160736|NCT01943292|BG002|Baseline|Defactinib 600 mg Bid|600 mg po bid defactinib
11160737|NCT01943292|BG003|Baseline|Total|Total of all reporting groups
11160738|NCT01943292|FG000|Participant Flow|Defactinib 200 mg Bid|200 mg bid (twice a day) po (by mouth) defactinib
11160739|NCT01943292|FG001|Participant Flow|Defactinib 400 mg Bid|400 mg bid po defactinib
11160740|NCT01943292|FG002|Participant Flow|Defactinib 600 mg Bid|600 mg bid po defactinib
11160741|NCT01943292|OG000|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
11160742|NCT01943292|OG001|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
11160743|NCT01943292|OG002|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
11160744|NCT01943292|EG000|Reported Event|Defactinib 200 mg Bid|200 mg po bid defactinib
11160745|NCT01943292|EG001|Reported Event|Defactinib 400 mg Bid|400 mg po bid defactinib
11160746|NCT01943292|EG002|Reported Event|Defactinib 600 mg Bid|600 mg po bid defactinib
11160747|NCT01943344|BG000|Baseline|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
11160748|NCT01943344|FG000|Participant Flow|Closure Device|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
11160749|NCT01943344|OG000|Outcome|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
11160750|NCT01943344|OG000|Outcome|Teatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
11160751|NCT01943344|OG000|Outcome|Treatment|Subjects that receive VIVASURE CLOSURE DEVICE™
11160752|NCT01943344|EG000|Reported Event|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
11160753|NCT01943435|BG000|Baseline|Usual Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.~Lumbar epidural injection: these will be prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications.~NSAIDs; adjunctive analgesics; adjunctive anti-depressants: Physician will administer these medications based upon the individual needs of each patient.~Lumbar epidural injection: The attending physician may refer s"
11160754|NCT01943435|BG001|Baseline|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
11160755|NCT01943435|BG002|Baseline|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
11160756|NCT01943435|BG003|Baseline|Total|Total of all reporting groups
11160757|NCT01943435|FG000|Participant Flow|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
11160758|NCT01943435|FG001|Participant Flow|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
11160759|NCT01943435|FG002|Participant Flow|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
11160760|NCT01943435|OG000|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
11160761|NCT01943435|OG001|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
11160762|NCT01943435|OG002|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
11160763|NCT01943435|EG000|Reported Event|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
11160764|NCT01943435|EG001|Reported Event|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
11160765|NCT01943435|EG002|Reported Event|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
11160766|NCT01943461|BG000|Baseline|Dose-escalation Cohort: Avelumab 3 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160767|NCT01943461|BG001|Baseline|Dose-escalation Cohort: Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160768|NCT01943461|BG002|Baseline|Dose-escalation Cohort: Avelumab 20 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11173952|NCT02018887|OG007|Outcome|Cohort 3 - 20 mg LY2969822 QD Day 14 (Fasted)|20 mg LY2969822 administered QD, PO, for 14 days.
11349179|NCT04115358|EG002|Reported Event|Ferric Sulfate|"0,1 ml to the orifice of the root canals of the primary molar~Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material."
11160769|NCT01943461|BG003|Baseline|Expansion Cohort: Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the expansion cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160770|NCT01943461|BG004|Baseline|Total|Total of all reporting groups
11160771|NCT01943461|FG000|Participant Flow|Dose-escalation Cohort: Avelumab 3 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160772|NCT01943461|FG001|Participant Flow|Dose-escalation Cohort: Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160773|NCT01943461|FG002|Participant Flow|Dose-escalation Cohort: Avelumab 20 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160774|NCT01943461|FG003|Participant Flow|Expansion Cohort: Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the expansion cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160775|NCT01943461|OG000|Outcome|Dose-escalation Cohort: Avelumab 3 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160776|NCT01943461|OG001|Outcome|Dose-escalation Cohort: Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160777|NCT01943461|OG002|Outcome|Dose-escalation Cohort: Avelumab 20 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160778|NCT01943461|OG000|Outcome|Expansion Cohort: Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the expansion cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160779|NCT01943461|EG000|Reported Event|Dose-escalation Cohort: Avelumab 3 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160780|NCT01943461|EG001|Reported Event|Dose-escalation Cohort: Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160781|NCT01943461|EG002|Reported Event|Dose-escalation Cohort: Avelumab 20 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg once every 2 weeks in the dose-escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160782|NCT01943461|EG003|Reported Event|Expansion Cohort: Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the expansion cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
11160783|NCT01943474|BG000|Baseline|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
11160784|NCT01943474|BG001|Baseline|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
11160785|NCT01943474|BG002|Baseline|Total|Total of all reporting groups
11160786|NCT01943474|FG000|Participant Flow|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
11160787|NCT01943474|FG001|Participant Flow|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
11160788|NCT01943474|OG000|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
11160789|NCT01943474|OG001|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
11160790|NCT01943474|EG000|Reported Event|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
11173953|NCT02018887|OG008|Outcome|Cohort 3 - 20 mg LY2969822 QD Day 10 (Fed)|20 mg LY2969822 administered QD, PO, for 14 days.
11160791|NCT01943474|EG001|Reported Event|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
11160792|NCT01943539|BG000|Baseline|EVO Game Play|"Neuro-typical controls and ADHD will receive EVO game play.~Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application"
11160793|NCT01943539|FG000|Participant Flow|Neuro-typical Controls|Non-ADHD neuro-typical children
11160794|NCT01943539|FG001|Participant Flow|ADHD|Children diagnosed with ADHD and not on ADHD medication.
11160795|NCT01943539|OG000|Outcome|EVO Game Play|"Neuro-typical controls and ADHD will receive EVO game play.~Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application"
11160796|NCT01943539|OG000|Outcome|Neurotypical Controls|Non-ADHD neuro-typical children
11160797|NCT01943539|OG001|Outcome|ADHD|Children diagnosed with ADHD and not taking ADHD medication
11160798|NCT01943539|EG000|Reported Event|Neurotypical Controls|Non-ADHD neurotypical children
11160799|NCT01943539|EG001|Reported Event|ADHD|Children diagnosed with ADHD and no on ADHD medication
11160800|NCT01943552|BG000|Baseline|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
11160801|NCT01943552|BG001|Baseline|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
11160802|NCT01943552|BG002|Baseline|Total|Total of all reporting groups
11160803|NCT01943552|FG000|Participant Flow|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
11160804|NCT01943552|FG001|Participant Flow|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
11160805|NCT01943552|OG000|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
11160806|NCT01943552|OG001|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
11160807|NCT01943552|EG000|Reported Event|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
11160808|NCT01943552|EG001|Reported Event|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
11160809|NCT01943565|BG000|Baseline|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160810|NCT01943565|BG001|Baseline|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160811|NCT01943565|BG002|Baseline|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160812|NCT01943565|BG003|Baseline|Total|Total of all reporting groups
11160813|NCT01943565|FG000|Participant Flow|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160814|NCT01943565|FG001|Participant Flow|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160815|NCT01943565|FG002|Participant Flow|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160816|NCT01943565|OG000|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160817|NCT01943565|OG001|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160818|NCT01943565|OG002|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160819|NCT01943565|EG000|Reported Event|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160820|NCT01943565|EG001|Reported Event|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160821|NCT01943565|EG002|Reported Event|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
11160822|NCT01943591|BG000|Baseline|15-caliber Platinum Coils|"Endovascular embolization coiling using 15-caliber platinum coils~Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils: Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils."
11160823|NCT01943591|BG001|Baseline|10-caliber Coils|"Endovascular embolization coiling using standard 10-caliber platinum coils~Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils: Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils."
11160824|NCT01943591|BG002|Baseline|Total|Total of all reporting groups
11160825|NCT01943591|FG000|Participant Flow|15-caliber Platinum Coils|"Endovascular embolization coiling using 15-caliber platinum coils~Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils: Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils."
11160826|NCT01943591|FG001|Participant Flow|10-caliber Coils|"Endovascular embolization coiling using standard 10-caliber platinum coils~Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils: Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils."
11160827|NCT01943591|OG000|Outcome|15-caliber Platinum Coils|"Endovascular embolization coiling using 15-caliber platinum coils~Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils: Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils."
11160828|NCT01943591|OG001|Outcome|10-caliber Coils|"Endovascular embolization coiling using standard 10-caliber platinum coils~Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils: Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils."
11160829|NCT01943591|EG000|Reported Event|15-caliber Platinum Coils|"Endovascular embolization coiling using 15-caliber platinum coils~Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils: Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils."
11160830|NCT01943591|EG001|Reported Event|10-caliber Coils|"Endovascular embolization coiling using standard 10-caliber platinum coils~Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils: Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils."
11160831|NCT01943799|BG000|Baseline|OAV Alone (Group A)|Participants continued to receive their prebaseline OAV regimen alone from baseline to Week 48. Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160832|NCT01943799|BG001|Baseline|OAV + GS-4774 2 YU (Group B)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 2 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160833|NCT01943799|BG002|Baseline|OAV + GS-4774 10 YU (Group C)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160834|NCT01943799|BG003|Baseline|OAV + GS-4774 40 YU (Group D)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160835|NCT01943799|BG004|Baseline|Total|Total of all reporting groups
11160836|NCT01943799|FG000|Participant Flow|OAV Alone (Group A)|Participants continued to receive their prebaseline oral antiviral (OAV) regimen alone from baseline to Week 48. Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160837|NCT01943799|FG001|Participant Flow|OAV + GS-4774 2 YU (Group B)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160838|NCT01943799|FG002|Participant Flow|OAV + GS-4774 10 YU (Group C)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160839|NCT01943799|FG003|Participant Flow|OAV + GS-4774 40 YU (Group D)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160840|NCT01943799|OG000|Outcome|OAV Alone (Group A)|Participants continued to receive their prebaseline OAV regimen alone from baseline to Week 48. Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160841|NCT01943799|OG001|Outcome|OAV + GS-4774 2 YU (Group B)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 2 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160842|NCT01943799|OG002|Outcome|OAV + GS-4774 10 YU (Group C)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160843|NCT01943799|OG003|Outcome|OAV + GS-4774 40 YU (Group D)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160844|NCT01943799|EG000|Reported Event|OAV Alone (Group A)|Participants continued to receive their prebaseline OAV regimen alone from baseline to Week 48. Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11173954|NCT02018887|OG009|Outcome|Cohort 4 - 6 mg LY2969822 QD Day 1|6 mg up to 40 mg LY2969822 administered QD, PO, for 14 days. Titration: 6 mg QD for 3 days, 20 mg QD for 2 days, and 40 mg QD for 9 days.
11160845|NCT01943799|EG001|Reported Event|OAV + GS-4774 2 YU (Group B)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 2 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160846|NCT01943799|EG002|Reported Event|OAV + GS-4774 10 YU (Group C)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160847|NCT01943799|EG003|Reported Event|OAV + GS-4774 40 YU (Group D)|Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination.
11160848|NCT01943851|BG000|Baseline|Part 1: GSK525762 5 mg QD|Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
11160849|NCT01943851|BG001|Baseline|Part 1: GSK525762 10 mg QD|Participants were administered once daily oral dose of 10 mg GSK525762.
11160850|NCT01943851|BG002|Baseline|Part 1: GSK525762 20 mg QD|Participants were administered once daily oral dose of 20 mg GSK525762.
11160851|NCT01943851|BG003|Baseline|Part 1: GSK525762 30 mg QD MM|Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
11160852|NCT01943851|BG004|Baseline|Part 1: GSK525762 40 mg QD|Participants were administered once daily oral dose of 40 mg GSK525762.
11160853|NCT01943851|BG005|Baseline|Part 1: GSK525762 40 mg QD MM|Participants with MM were administered once daily oral dose of 40 mg GSK525762.
11160854|NCT01943851|BG006|Baseline|Part 1: GSK525762 60 mg QD AML|Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
11160855|NCT01943851|BG007|Baseline|Part 1: GSK525762 60 mg QD NHL|Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
11160856|NCT01943851|BG008|Baseline|Part 1: GSK525762 60 mg QD MM|Participants with MM were administered once daily oral dose of 60 mg GSK525762.
11160857|NCT01943851|BG009|Baseline|Part 1: GSK525762 75 mg QD AML|Participants with AML were administered once daily oral dose of 75 mg GSK525762.
11160858|NCT01943851|BG010|Baseline|Part 1: GSK525762 80 mg QD|Participants were administered once daily oral dose of 80 mg GSK525762.
11160859|NCT01943851|BG011|Baseline|Part 1: GSK525762 80 mg QD AML|Participants with AML were administered once daily oral dose of 80 mg GSK525762.
11160860|NCT01943851|BG012|Baseline|Part 1: GSK525762 80 mg QD NHL|Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
11160861|NCT01943851|BG013|Baseline|Part 1: GSK525762 100 mg QD AML|Participants with AML were administered once daily oral dose of 100 mg GSK525762.
11160862|NCT01943851|BG014|Baseline|Part 1: GSK525762 120 mg QD AML|Participants with AML were administered once daily oral dose of 120 mg GSK525762.
11160863|NCT01943851|BG015|Baseline|Part 2: GSK525762 60 mg QD CTCL|Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
11160864|NCT01943851|BG016|Baseline|Part 2: GSK525762 75 mg QD MDS|Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
11160865|NCT01943851|BG017|Baseline|Part 2: GSK525762 80 mg QD CTCL|Participants CTCL were administered once daily oral dose of 80 mg GSK525762
11160866|NCT01943851|BG018|Baseline|Total|Total of all reporting groups
11160867|NCT01943851|FG000|Participant Flow|Part 1: GSK525762 5 mg QD|Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
11160868|NCT01943851|FG001|Participant Flow|Part 1: GSK525762 10 mg QD|Participants were administered once daily oral dose of 10 mg GSK525762.
11160869|NCT01943851|FG002|Participant Flow|Part 1: GSK525762 20 mg QD|Participants were administered once daily oral dose of 20 mg GSK525762.
11160870|NCT01943851|FG003|Participant Flow|Part 1: GSK525762 30 mg QD MM|Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
11160871|NCT01943851|FG004|Participant Flow|Part 1: GSK525762 40 mg QD|Participants were administered once daily oral dose of 40 mg GSK525762.
11160872|NCT01943851|FG005|Participant Flow|Part 1: GSK525762 40 mg QD MM|Participants with MM were administered once daily oral dose of 40 mg GSK525762.
11160873|NCT01943851|FG006|Participant Flow|Part 1: GSK525762 60 mg QD AML|Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
11160874|NCT01943851|FG007|Participant Flow|Part 1: GSK525762 60 mg QD NHL|Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
11160875|NCT01943851|FG008|Participant Flow|Part 1: GSK525762 60 mg QD MM|Participants with MM were administered once daily oral dose of 60 mg GSK525762.
11160876|NCT01943851|FG009|Participant Flow|Part 1: GSK525762 75 mg QD AML|Participants with AML were administered once daily oral dose of 75 mg GSK525762.
11160877|NCT01943851|FG010|Participant Flow|Part 1: GSK525762 80 mg QD|Participants were administered once daily oral dose of 80 mg GSK525762.
11160878|NCT01943851|FG011|Participant Flow|Part 1: GSK525762 80 mg QD AML|Participants with AML were administered once daily oral dose of 80 mg GSK525762.
11160879|NCT01943851|FG012|Participant Flow|Part 1: GSK525762 80 mg QD NHL|Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
11160880|NCT01943851|FG013|Participant Flow|Part 1: GSK525762 100 mg QD AML|Participants with AML were administered once daily oral dose of 100 mg GSK525762.
11160881|NCT01943851|FG014|Participant Flow|Part 1: GSK525762 120 mg QD AML|Participants with AML were administered once daily oral dose of 120 mg GSK525762.
11160882|NCT01943851|FG015|Participant Flow|Part 2: GSK525762 60 mg QD CTCL|Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
11160883|NCT01943851|FG016|Participant Flow|Part 2: GSK525762 75 mg QD MDS|Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
11160884|NCT01943851|FG017|Participant Flow|Part 2: GSK525762 80 mg QD CTCL|Participants CTCL were administered once daily oral dose of 80 mg GSK525762
11160885|NCT01943851|OG000|Outcome|Part 1: GSK525762 5 mg QD|Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
11160886|NCT01943851|OG001|Outcome|Part 1: GSK525762 10 mg QD|Participants were administered once daily oral dose of 10 mg GSK525762.
11160887|NCT01943851|OG002|Outcome|Part 1: GSK525762 20 mg QD|Participants were administered once daily oral dose of 20 mg GSK525762.
11160888|NCT01943851|OG003|Outcome|Part 1: GSK525762 30 mg QD MM|Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
11160889|NCT01943851|OG004|Outcome|Part 1: GSK525762 40 mg QD|Participants were administered once daily oral dose of 40 mg GSK525762.
11160890|NCT01943851|OG005|Outcome|Part 1: GSK525762 40 mg QD MM|Participants with MM were administered once daily oral dose of 40 mg GSK525762.
11160891|NCT01943851|OG006|Outcome|Part 1: GSK525762 60 mg QD AML|Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
11160892|NCT01943851|OG007|Outcome|Part 1: GSK525762 60 mg QD NHL|Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
11160893|NCT01943851|OG008|Outcome|Part 1: GSK525762 60 mg QD MM|Participants with MM were administered once daily oral dose of 60 mg GSK525762.
11160894|NCT01943851|OG009|Outcome|Part 1: GSK525762 75 mg QD AML|Participants with AML were administered once daily oral dose of 75 mg GSK525762.
11160895|NCT01943851|OG010|Outcome|Part 1: GSK525762 80 mg QD|Participants were administered once daily oral dose of 80 mg GSK525762.
11160896|NCT01943851|OG011|Outcome|Part 1: GSK525762 80 mg QD AML|Participants with AML were administered once daily oral dose of 80 mg GSK525762.
11160897|NCT01943851|OG012|Outcome|Part 1: GSK525762 80 mg QD NHL|Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
11160898|NCT01943851|OG013|Outcome|Part 1: GSK525762 100 mg QD AML|Participants with AML were administered once daily oral dose of 100 mg GSK525762.
11160899|NCT01943851|OG014|Outcome|Part 1: GSK525762 120 mg QD AML|Participants with AML were administered once daily oral dose of 120 mg GSK525762.
11160900|NCT01943851|OG005|Outcome|Part 1: GSK525762 40 mg QD MM|Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
11160901|NCT01943851|OG000|Outcome|Part 2: GSK525762 75 mg QD MDS|Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
11160902|NCT01943851|OG000|Outcome|Part 2: GSK525762 60 mg QD CTCL|Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
11160903|NCT01943851|OG001|Outcome|Part 2: GSK525762 80 mg QD CTCL|Participants CTCL were administered once daily oral dose of 80 mg GSK525762
11160904|NCT01943851|OG001|Outcome|Part 2: GSK525762 75 mg QD MDS|Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
11160905|NCT01943851|OG002|Outcome|Part 2: GSK525762 80 mg QD CTCL|Participants CTCL were administered once daily oral dose of 80 mg GSK525762
11160906|NCT01943851|EG000|Reported Event|GSK525762 5 MG QD|Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
11160907|NCT01943851|EG001|Reported Event|GSK525762 10 MG QD|Participants were administered once daily oral dose of 10 mg GSK525762.
11160908|NCT01943851|EG002|Reported Event|GSK525762 20 MG QD|Participants were administered once daily oral dose of 20 mg GSK525762.
11160909|NCT01943851|EG003|Reported Event|GSK525762 30 MG QD MM|Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
11160910|NCT01943851|EG004|Reported Event|GSK525762 40 MG QD|Participants were administered once daily oral dose of 40 mg GSK525762.
11160911|NCT01943851|EG005|Reported Event|GSK525762 40 MG QD MM|Participants with MM were administered once daily oral dose of 40 mg GSK525762.
11160912|NCT01943851|EG006|Reported Event|GSK525762 60 MG QD AML|Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 40 mg GSK525762.
11160913|NCT01943851|EG007|Reported Event|GSK525762 60 MG QD NHL|Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
11160914|NCT01943851|EG008|Reported Event|GSK525762 60 MG QD MM|Participants with MM were administered once daily oral dose of 60 mg GSK525762.
11160915|NCT01943851|EG009|Reported Event|GSK525762 75 MG QD AML|Participants with AML were administered once daily oral dose of 75 mg GSK525762.
11160916|NCT01943851|EG010|Reported Event|GSK525762 80 MG QD|Participants were administered once daily oral dose of 80 mg GSK525762.
11160917|NCT01943851|EG011|Reported Event|GSK525762 80 MG QD AML|Participants with AML were administered once daily oral dose of 80 mg GSK525762.
11160918|NCT01943851|EG012|Reported Event|GSK525762 80 MG QD NHL|Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
11160919|NCT01943851|EG013|Reported Event|GSK525762 100 MG QD AML|Participants with AML were administered once daily oral dose of 100 mg GSK525762.
11160920|NCT01943851|EG014|Reported Event|GSK525762 120 MG QD AML|Participants with AML were administered once daily oral dose of 120 mg GSK525762.
11160921|NCT01943851|EG015|Reported Event|GSK525762 60 MG QD CTCL|Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
11160922|NCT01943851|EG016|Reported Event|GSK525762 75 MG QD MDS|Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
11160923|NCT01943851|EG017|Reported Event|GSK525762 80 MG QD CTCL|Participants CTCL were administered once daily oral dose of 80 mg GSK525762.
11160924|NCT01943864|BG000|Baseline|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
11160925|NCT01943864|FG000|Participant Flow|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
11160926|NCT01943864|OG000|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
11160927|NCT01943864|EG000|Reported Event|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
11160928|NCT01943916|BG000|Baseline|Overall Population|Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore baseline data are for overall population only.
11160929|NCT01943916|FG000|Participant Flow|Overall Population|Each subject served as her own control, with imaging of each mass by both the test Imagio (IUS+OA) and control (IUS only) modalities; therefore baseline data are not broken into each arm - test and control due the numbers being the same for each arm.
11160930|NCT01943916|OG000|Outcome|Overall Population|Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
11160931|NCT01943916|OG000|Outcome|Overall Population|Each subject served as her own control, with imaging of each mass by both the test and control modalities. Sensitivity difference is a single measure for the overall ITD population.
11160932|NCT01943916|OG000|Outcome|Imagio Ultrasound (IUS) Gray-scale Ultrasound Imaging of Mass|Imagio Ultrasound (IUS) gray-scale ultrasound imaging of mass
11160933|NCT01943916|OG001|Outcome|OA/US|Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass
11160934|NCT01943916|OG001|Outcome|Imagio (OA/US)|Imagio optoacoustic imaging plus grayscale imaging of mass
11160935|NCT01943916|OG000|Outcome|Overall ITD Population|Each subject served as her own control, with imaging of each mass by both the test and control modalities. Downgrades are based on Imagio optoacoustic plus grayscale (OA/US) relative to Imagio grayscale (IUS), thus this is a single measure for the over all ITD population.
11160936|NCT01943916|EG000|Reported Event|Safety Population|Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore safety data are for overall safety population only.
11173955|NCT02018887|OG010|Outcome|Cohort 4 - 40 mg LY2969822 QD Day 14|6 mg up to 40 mg LY2969822 administered QD, PO, for 14 days. Titration: 6 mg QD for 3 days, 20 mg QD for 2 days, and 40 mg QD for 9 days.
11173956|NCT02018887|OG011|Outcome|Cohort 5 - 6 mg LY2969822 QD Day 1|6 mg up to 80 mg LY2969822 administered QD, PO, for 14 days. Titration: 6 mg QD for 2 days, 20 mg QD for 2 days, 40 mg QD for 2 days and 80 mg QD for 8 days.
11173957|NCT02018887|OG012|Outcome|Cohort 5 - 80 mg LY2969822 QD Day 14|6 mg up to 80 mg LY2969822 administered QD, PO, for 14 days. Titration: 6 mg QD for 2 days, 20 mg QD for 2 days, 40 mg QD for 2 days and 80 mg QD for 8 days.
11173958|NCT02018887|OG013|Outcome|Cohort 6 - 6 mg LY2969822 BID Day 1|6 mg up to 80 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.
11173959|NCT02018887|OG014|Outcome|Cohort 6 - 80 mg LY2969822 BID Day 14|6 mg up to 80 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, 40 mg BID for 2 days, and 80 mg BID for 6 days.
11173960|NCT02018887|OG015|Outcome|Cohort 7 - 10 mg LY2969822 BID Day 1|10 mg up to 40 mg LY2969822 administered QD, PO, for 14 days. Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, and 40 mg BID for 12 days.
11173961|NCT02018887|OG016|Outcome|Cohort 7 - 40 mg LY2969822 BID Day 14|10 mg up to 40 mg LY2969822 administered QD, PO, for 14 days. Titration: 10 mg BID for 1 day, 20 mg BID for 1 day, and 40 mg BID for 12 days.
11173962|NCT02018887|OG017|Outcome|Cohort 8A - 6 mg LY2969822 BID Day 1|6 mg up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, and 40 mg BID for 8 days.
11173963|NCT02018887|OG018|Outcome|Cohort 8A - 40 mg BID LY2969822 Day 14|6 mg up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, and 40 mg BID for 8 days.
11173964|NCT02018887|OG019|Outcome|Cohort 8B - 6 mg LY2969822 BID Day 1|6 mg up to 20 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 10 days.
11173965|NCT02018887|OG020|Outcome|Cohort 8B - 20 mg BID LY2969822 Day 14|6 mg up to 20 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 10 days.
11173966|NCT02018887|OG000|Outcome|Cohort 8A - 40 mg BID LY2969822 Day 14|6 mg up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, and 40 mg BID for 8 days.
11173967|NCT02018887|OG001|Outcome|Cohort 8B - 20 mg BID LY2969822 Day 14|6 mg up to 20 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 10 days.
11173968|NCT02018887|OG019|Outcome|Cohort 8B - 6 mg BID Day 1|6 mg up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, and 40 mg BID for 8 days.
11173969|NCT02018887|OG020|Outcome|Cohort 8B - 20 mg BID Day 14|6 mg up to 40 mg LY2969822 administered BID, PO, for 14 days. Titration: 6 mg BID for 2 days, 10 mg BID for 2 days, 20 mg BID for 2 days, and 40 mg BID for 8 days.
11173970|NCT02018887|EG000|Reported Event|Part A: Placebo|Placebo administered once, PO.
11173971|NCT02018887|EG001|Reported Event|Part A: 2 mg LY2969822|2 mg LY2969822 administered once, PO.
11173972|NCT02018887|EG002|Reported Event|Part A: 6 mg LY2969822|6 mg LY2969822 administered once, PO.
11173973|NCT02018887|EG003|Reported Event|Part A: 20 mg LY2969822|20 mg LY2969822 administered once, PO.
11173974|NCT02018887|EG004|Reported Event|Part A: 40 mg LY2969822|40 mg LY2969822 administered once, PO.
11173975|NCT02018887|EG005|Reported Event|Part A: 60 mg LY2969822|60 mg LY2969822 administered once, PO.
11173976|NCT02018887|EG006|Reported Event|Part B: Placebo|Placebo administered QD, PO, for 14 days.
11173977|NCT02018887|EG007|Reported Event|Part B: Placebo BID|Placebo administered BID, PO, for 14 days.
11173978|NCT02018887|EG008|Reported Event|Part B: 6 mg LY2969822|6 mg LY2969822 administered QD, PO, for 2 - 3 days
11173979|NCT02018887|EG009|Reported Event|Part B: 6 mg LY2969822 BID|6 mg LY2969822 administered BID, PO, for 2 days.
11173980|NCT02018887|EG010|Reported Event|Part B: 10 mg LY2969822 BID|10 mg LY2969822 administered BID, PO, for 1-2 days.
11160937|NCT01944046|BG000|Baseline|Oxytocin Nasal Spray|"Oxytocin~Oxytocin Nasal Spray: Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day."
11160938|NCT01944046|BG001|Baseline|Placebo Nasal Spray|"Placebo~Placebo Nasal Spray: This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except there will be no oxytocin added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug."
11160939|NCT01944046|BG002|Baseline|Total|Total of all reporting groups
11160940|NCT01944046|FG000|Participant Flow|Oxytocin Nasal Spray|"Oxytocin~Oxytocin Nasal Spray: Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day."
11160941|NCT01944046|FG001|Participant Flow|Placebo Nasal Spray|"Placebo~Placebo Nasal Spray: This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except there will be no oxytocin added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug."
11160942|NCT01944046|OG000|Outcome|Oxytocin Nasal Spray|"Oxytocin~Oxytocin Nasal Spray: Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day."
11160943|NCT01944046|OG001|Outcome|Placebo Nasal Spray|"Placebo~Placebo Nasal Spray: This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except there will be no oxytocin added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug."
11160944|NCT01944046|OG000|Outcome|Placebo Nasal Spray|"Placebo~Placebo Nasal Spray: This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except oxytocin will NOT be added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug."
11160945|NCT01944046|OG001|Outcome|Oxytocin Nasal Spray|"Oxytocin~Oxytocin Nasal Spray: Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day."
11160946|NCT01944046|EG000|Reported Event|Oxytocin Nasal Spray: Double-blind Phase|"Oxytocin~Oxytocin Nasal Spray: Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day."
11160947|NCT01944046|EG001|Reported Event|Placebo Nasal Spray: Double-blind Phase|"Placebo~Placebo Nasal Spray: This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except there will be no oxytocin added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug."
11173981|NCT02018887|EG011|Reported Event|Part B: 20 mg LY2969822|20 mg LY2969822 administered QD, PO, for up to 14 days.
11173982|NCT02018887|EG012|Reported Event|Part B: 20 mg LY2969822 BID|20 mg LY2969822 administered BID, PO, for 1-2 days.
11160948|NCT01944046|EG002|Reported Event|Oxytocin Nasal Spray: Open Label Phase|"Oxytocin~Oxytocin Nasal Spray: Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day."
11160949|NCT01944046|EG003|Reported Event|Placebo Nasal Spray: Open Label Phase|"Placebo~Placebo Nasal Spray: This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except there will be no oxytocin added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug."
11160950|NCT01944098|BG000|Baseline|Treatment Arm|Patients received 2mg/kg/hr of lidocaine intraoperatively from the time of induction until the time of emergence.
11160951|NCT01944098|BG001|Baseline|Placebo Arm|Patients received 2mg/kg/hr of placebo (saline) intraoperatively from the time of induction until the time of emergence.
11160952|NCT01944098|BG002|Baseline|Total|Total of all reporting groups
11160953|NCT01944098|FG000|Participant Flow|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
11160954|NCT01944098|FG001|Participant Flow|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
11160955|NCT01944098|OG000|Outcome|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
11160956|NCT01944098|OG001|Outcome|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
11160957|NCT01944098|EG000|Reported Event|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
11160958|NCT01944098|EG001|Reported Event|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
11160959|NCT01944293|BG000|Baseline|Ketamine|"0.5 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes"
11160960|NCT01944293|BG001|Baseline|Midazolam|"0.02 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes~Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes"
11160961|NCT01944293|BG002|Baseline|Total|Total of all reporting groups
11160962|NCT01944293|FG000|Participant Flow|Ketamine|"0.5 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes"
11160963|NCT01944293|FG001|Participant Flow|Midazolam|"0.02 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes~Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes"
11160964|NCT01944293|OG000|Outcome|Ketamine|"0.5 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes"
11160965|NCT01944293|OG001|Outcome|Midazolam|"0.02 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes~Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes"
11160966|NCT01944293|EG000|Reported Event|Ketamine|"0.5 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes"
11160967|NCT01944293|EG001|Reported Event|Midazolam|"0.02 mg/kg, I.V. (in the vein)~Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes~Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes"
11160968|NCT01944319|BG000|Baseline|Control Group|Meropenem therapy with regimen routinely decided by attending physician
11160969|NCT01944319|BG001|Baseline|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.~Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
11160970|NCT01944319|BG002|Baseline|Total|Total of all reporting groups
11160971|NCT01944319|FG000|Participant Flow|Control Group|Meropenem therapy with regimen routinely decided by attending physician
11160972|NCT01944319|FG001|Participant Flow|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.~Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
11160973|NCT01944319|OG000|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
11160974|NCT01944319|OG001|Outcome|Study Group|The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
11160975|NCT01944319|OG001|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
11160976|NCT01944319|EG000|Reported Event|Control Group|The participants in control group will accept routine meropenem therapy.
11160977|NCT01944319|EG001|Reported Event|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
11160978|NCT01944345|BG000|Baseline|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
11160979|NCT01944345|FG000|Participant Flow|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
11160980|NCT01944345|OG000|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
11160981|NCT01944345|EG000|Reported Event|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
11160982|NCT01944371|BG000|Baseline|Disulfiram 500mg|"500mg disulfiram by mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160983|NCT01944371|BG001|Baseline|Disulfiram 1000mg|"1000mg disulfiram by mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160984|NCT01944371|BG002|Baseline|Disulfiram 2000mg|"2000mg disulfiram per mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160985|NCT01944371|BG003|Baseline|Total|Total of all reporting groups
11160986|NCT01944371|FG000|Participant Flow|Disulfiram 500mg|"500mg disulfiram by mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160987|NCT01944371|FG001|Participant Flow|Disulfiram 1000mg|"1000mg disulfiram by mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160988|NCT01944371|FG002|Participant Flow|Disulfiram 2000mg|"2000mg disulfiram per mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160989|NCT01944371|OG000|Outcome|Disulfiram 500mg|"500mg disulfiram by mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160990|NCT01944371|OG001|Outcome|Disulfiram 1000mg|"1000mg disulfiram by mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160991|NCT01944371|OG002|Outcome|Disulfiram 2000mg|"2000mg disulfiram per mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160992|NCT01944371|EG000|Reported Event|Disulfiram 500mg|"500mg disulfiram by mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160993|NCT01944371|EG001|Reported Event|Disulfiram 1000mg|"1000mg disulfiram by mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160994|NCT01944371|EG002|Reported Event|Disulfiram 2000mg|"2000mg disulfiram per mouth per day for 3 days~Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days."
11160995|NCT01944423|BG000|Baseline|PSRT_DCS|"Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).~d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction."
11160996|NCT01944423|BG001|Baseline|PSRT_PBO|"Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).~Pill Placebo"
11160997|NCT01944423|BG002|Baseline|Total|Total of all reporting groups
11160998|NCT01944423|FG000|Participant Flow|PSRT_DCS|"Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).~d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction."
11160999|NCT01944423|FG001|Participant Flow|PSRT_PBO|"Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).~Pill Placebo"
11161000|NCT01944423|OG000|Outcome|PSRT_DCS|"Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).~d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction."
11161001|NCT01944423|OG001|Outcome|PSRT_PBO|"Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).~Pill Placebo"
11161002|NCT01944423|EG000|Reported Event|PSRT_DCS|"Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).~d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction."
11161003|NCT01944423|EG001|Reported Event|PSRT_PBO|"Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).~Pill Placebo"
11161004|NCT01944462|BG000|Baseline|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
11161005|NCT01944462|FG000|Participant Flow|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
11161006|NCT01944462|OG000|Outcome|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
11161007|NCT01944462|OG000|Outcome|Pharmacy Staff|Pharmacy staff (pharmacy faculty and students) were surveyed after the completion of the program to determine their satisfaction with the program.
11161008|NCT01944462|EG000|Reported Event|PPPP Participants - Vaccine Recipients|Subgroup of participants receiving the pneumococcal vaccine (Pneumococcal Vaccine Polyvalent (Pneumovax® 23))
11161009|NCT01944631|BG000|Baseline|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
11161010|NCT01944631|BG001|Baseline|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
11161011|NCT01944631|BG002|Baseline|Total|Total of all reporting groups
11161012|NCT01944631|FG000|Participant Flow|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
11161013|NCT01944631|FG001|Participant Flow|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
11161014|NCT01944631|OG000|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
11161015|NCT01944631|OG001|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
11161016|NCT01944631|EG000|Reported Event|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
11161017|NCT01944631|EG001|Reported Event|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
11161018|NCT01944644|BG000|Baseline|Active Low Field Magnetic Stimulation|"LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.~Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain."
11161019|NCT01944644|BG001|Baseline|Sham Low Field Magnetic Stimulation|"Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.~Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment."
11161020|NCT01944644|BG002|Baseline|Total|Total of all reporting groups
11161021|NCT01944644|FG000|Participant Flow|Active Low Field Magnetic Stimulation|"LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.~Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain."
11161022|NCT01944644|FG001|Participant Flow|Sham Low Field Magnetic Stimulation|"Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.~Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment."
11161023|NCT01944644|OG000|Outcome|Active Low Field Magnetic Stimulation|"LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.~Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain."
11161024|NCT01944644|OG001|Outcome|Sham Low Field Magnetic Stimulation|"Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.~Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment."
11161025|NCT01944644|EG000|Reported Event|Active Low Field Magnetic Stimulation|"LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.~Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain."
11161026|NCT01944644|EG001|Reported Event|Sham Low Field Magnetic Stimulation|"Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.~Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment."
11173983|NCT02018887|EG013|Reported Event|Part B: 40 mg LY2969822|40 mg LY2969822 administered QD, PO, for up to 9 days.
11161027|NCT01944670|BG000|Baseline|Internal Joint Stabilizer Group|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
11161028|NCT01944670|FG000|Participant Flow|Internal Joint Stabilizer Group|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
11161029|NCT01944670|OG000|Outcome|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
11161030|NCT01944670|EG000|Reported Event|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
11161031|NCT01944722|BG000|Baseline|ASCUS Aged 21 Years and Older|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
11161032|NCT01944722|BG001|Baseline|NILM Aged 30 Years and Older|Participants aged 30 years and older and having cytology results that are negative for intraepithelial lesions or malignancy (NILM).
11161033|NCT01944722|BG002|Baseline|Total|Total of all reporting groups
11161034|NCT01944722|FG000|Participant Flow|BD Onclarity™ HPV Assay on BD Viper™ LT|"The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene (HC2) HPV and a polymerase chain reaction (PCR) sequencing test.~Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or a random sampling of subjects with normal cytology and HPV negative test results."
11161035|NCT01944722|OG000|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
11161036|NCT01944722|OG001|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
11161037|NCT01944722|OG000|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
11161038|NCT01944722|OG001|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
11161039|NCT01944722|OG000|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
11161040|NCT01944722|OG000|Outcome|BD Onclarity™ HPV Assay on BD Viper™ LT|"The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument.~The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene (HC2) HPV and a polymerase chain reaction (PCR) sequencing test.~Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or a random sampling of subjects with normal cytology and HPV negative test results."
11161041|NCT01944722|EG000|Reported Event|BD HPV Onclarity™ Assay on BD Viper™ LT|Subjects tested with the BD HPV Onclarity™ assay on the BD Viper™ LT instrument.
11161042|NCT01944774|BG000|Baseline|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
11161043|NCT01944774|BG001|Baseline|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
11161044|NCT01944774|BG002|Baseline|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
11161045|NCT01944774|BG003|Baseline|Total|Total of all reporting groups
11161046|NCT01944774|FG000|Participant Flow|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
11161047|NCT01944774|FG001|Participant Flow|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
11161048|NCT01944774|FG002|Participant Flow|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
11161049|NCT01944774|OG000|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
11161050|NCT01944774|OG001|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
11161051|NCT01944774|OG002|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
11161052|NCT01944774|OG000|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
11161053|NCT01944774|OG001|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
11161054|NCT01944774|OG002|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
11161055|NCT01944774|EG000|Reported Event|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
11161056|NCT01944774|EG001|Reported Event|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
11161057|NCT01944774|EG002|Reported Event|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
11161058|NCT01944839|BG000|Baseline|E10030 + Ranibizumab|"E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection~E10030~ranibizumab"
11161059|NCT01944839|BG001|Baseline|Sham + Ranibizumab|"E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection~ranibizumab~E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle"
11161060|NCT01944839|BG002|Baseline|Total|Total of all reporting groups
11161061|NCT01944839|FG000|Participant Flow|E10030 + Ranibizumab|"E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection~E10030~ranibizumab"
11161062|NCT01944839|FG001|Participant Flow|Sham + Ranibizumab|"E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection~ranibizumab~E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle"
11161063|NCT01944839|OG000|Outcome|E10030 + Ranibizumab|"E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection~E10030~ranibizumab"
11173984|NCT02018887|EG014|Reported Event|Part B: 40 mg LY2969822 BID|40 mg LY2969822 administered BID, PO, for up to 12 days.
11161064|NCT01944839|OG001|Outcome|Sham + Ranibizumab|"E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection~ranibizumab~E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle"
11161065|NCT01944839|EG000|Reported Event|E10030 + Ranibizumab|"E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection~E10030~ranibizumab"
11161066|NCT01944839|EG001|Reported Event|Sham + Ranibizumab|"E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection~ranibizumab~E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle"
11161067|NCT01944878|BG000|Baseline|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
11161068|NCT01944878|BG001|Baseline|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
11161069|NCT01944878|BG002|Baseline|Total|Total of all reporting groups
11161070|NCT01944878|FG000|Participant Flow|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
11161071|NCT01944878|FG001|Participant Flow|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
11161072|NCT01944878|OG000|Outcome|PUD in Liver Cirrhosis|Patients with PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
11161073|NCT01944878|OG001|Outcome|No PUD in Liver Cirrhosis|Patients without PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
11161074|NCT01944878|OG000|Outcome|PUD in Chronic Hepatitis|
11161075|NCT01944878|OG001|Outcome|No PUD in Lchronic Hepatitis|
11161076|NCT01944878|EG000|Reported Event|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
11161077|NCT01944878|EG001|Reported Event|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
11161078|NCT01944930|BG000|Baseline|Narrow Band Imaging Laparoscopy First|"Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.~Laparoscopic narrow band imaging~Standard white-light laparoscopy"
11161079|NCT01944930|BG001|Baseline|Standard White-Light Laparoscopy First|"Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy.~Laparoscopic narrow band imaging~Standard white-light laparoscopy"
11161080|NCT01944930|BG002|Baseline|Total|Total of all reporting groups
11161081|NCT01944930|FG000|Participant Flow|Narrow Band Imaging Laparoscopy First|"Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.~Laparoscopic narrow band imaging~Standard white-light laparoscopy"
11161082|NCT01944930|FG001|Participant Flow|Standard White-Light Laparoscopy First|"Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy.~Laparoscopic narrow band imaging~Standard white-light laparoscopy"
11161083|NCT01944930|OG000|Outcome|Narrow Band Imaging Laparoscopy|"Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.~Laparoscopic narrow band imaging"
11161084|NCT01944930|OG001|Outcome|Standard White-Light Laparoscopy|"Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy.~Standard white-light laparoscopy"
11161085|NCT01944930|EG000|Reported Event|Narrow Band Imaging Laparoscopy First|"Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy. Therefore any adverse event cannot be traced back to each single intervention and can only be described cumulative.~Laparoscopic narrow band imaging~Standard white-light laparoscopy"
11161086|NCT01944930|EG001|Reported Event|Standard White-Light Laparoscopy First|"Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy. Therefore any adverse event cannot be traced back to each single intervention and can only be described cumulative.~Laparoscopic narrow band imaging~Standard white-light laparoscopy"
11161087|NCT01944969|BG000|Baseline|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
11161088|NCT01944969|FG000|Participant Flow|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
11161089|NCT01944969|OG000|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
11161090|NCT01944969|OG000|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1,2, or 3 mg/day, once daily dose, tablets, orally"
11161091|NCT01944969|OG000|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
11161092|NCT01944969|EG000|Reported Event|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
11161093|NCT01945034|BG000|Baseline|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
11161094|NCT01945034|BG001|Baseline|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
11161095|NCT01945034|BG002|Baseline|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
11161096|NCT01945034|BG003|Baseline|Total|Total of all reporting groups
11161097|NCT01945034|FG000|Participant Flow|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
11161098|NCT01945034|FG001|Participant Flow|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
11161099|NCT01945034|FG002|Participant Flow|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
11161100|NCT01945034|OG000|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
11161101|NCT01945034|OG001|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
11161102|NCT01945034|OG002|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
11161103|NCT01945034|EG000|Reported Event|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
11161104|NCT01945034|EG001|Reported Event|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
11161105|NCT01945034|EG002|Reported Event|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
11161106|NCT01945086|BG000|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
11161107|NCT01945086|BG001|Baseline|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
11161108|NCT01945086|BG002|Baseline|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
11161109|NCT01945086|BG003|Baseline|Total|Total of all reporting groups
11161110|NCT01945086|FG000|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
11161111|NCT01945086|FG001|Participant Flow|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
11161112|NCT01945086|FG002|Participant Flow|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
11161113|NCT01945086|OG000|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
11161114|NCT01945086|OG001|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
11161115|NCT01945086|OG002|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
11161116|NCT01945086|EG000|Reported Event|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
11161117|NCT01945086|EG001|Reported Event|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
11161118|NCT01945086|EG002|Reported Event|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
11161119|NCT01945112|BG000|Baseline|Paper Tape|Paper was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
11161120|NCT01945112|FG000|Participant Flow|Paper Tape on Right and No Tape on Left Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
11161121|NCT01945112|FG001|Participant Flow|Paper Tape on Left and No Tape on Right Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
11161122|NCT01945112|OG000|Outcome|Paper Tape|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
11161123|NCT01945112|EG000|Reported Event|Paper Tape on RIght Foot and No Tape on Left Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
11161124|NCT01945112|EG001|Reported Event|Tape on Left Foot and No Tape on Right Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
11161125|NCT01945138|BG000|Baseline|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
11161126|NCT01945138|BG001|Baseline|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
11161127|NCT01945138|BG002|Baseline|Total|Total of all reporting groups
11161128|NCT01945138|FG000|Participant Flow|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
11161129|NCT01945138|FG001|Participant Flow|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
11161130|NCT01945138|OG000|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
11161131|NCT01945138|OG001|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
11161132|NCT01945138|EG000|Reported Event|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
11161133|NCT01945138|EG001|Reported Event|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
11161134|NCT01945216|BG000|Baseline|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161135|NCT01945216|BG001|Baseline|Alogliptin + αGI|Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161136|NCT01945216|BG002|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
11161137|NCT01945216|BG003|Baseline|Total|Total of all reporting groups
11161138|NCT01945216|FG000|Participant Flow|Overall Population|Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 36 months along with an alpha-glucosidase inhibitor (α-GI), without an α-GI, or the other diabetic drugs from the start of administration of alogliptin and during the treatment period of alogliptin in routine medical care.
11161139|NCT01945216|OG000|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161140|NCT01945216|OG001|Outcome|Alogliptin + α-GI|Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161141|NCT01945216|OG002|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
11161142|NCT01945216|EG000|Reported Event|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161143|NCT01945216|EG001|Reported Event|Alogliptin + αGI|Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161144|NCT01945216|EG002|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
11161145|NCT01945242|BG000|Baseline|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161146|NCT01945242|BG001|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
11161147|NCT01945242|BG002|Baseline|Total|Total of all reporting groups
11161148|NCT01945242|FG000|Participant Flow|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161149|NCT01945242|FG001|Participant Flow|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
11161150|NCT01945242|OG000|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11161151|NCT01945242|OG001|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
11161152|NCT01945242|OG000|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
11161153|NCT01945242|EG000|Reported Event|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
11173985|NCT02018887|EG015|Reported Event|Part B: 80 mg LY2969822|80 mg LY2969822 administered QD, PO, for 8 days.
11161154|NCT01945242|EG001|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
11161155|NCT01945281|BG000|Baseline|Caspofungin|Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
11161156|NCT01945281|BG001|Baseline|Amphotericin B Deoxycholate|Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
11161157|NCT01945281|BG002|Baseline|Total|Total of all reporting groups
11161158|NCT01945281|FG000|Participant Flow|Caspofungin|Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
11161159|NCT01945281|FG001|Participant Flow|Amphotericin B Deoxycholate|Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
11161160|NCT01945281|OG000|Outcome|Caspofungin|Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
11161161|NCT01945281|OG001|Outcome|Amphotericin B Deoxycholate|Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
11161162|NCT01945281|EG000|Reported Event|Caspofungin|Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
11161163|NCT01945281|EG001|Reported Event|Amphotericin B Deoxycholate|Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
11161164|NCT01945294|BG000|Baseline|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
11161165|NCT01945294|BG001|Baseline|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
11161166|NCT01945294|BG002|Baseline|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
11161167|NCT01945294|BG003|Baseline|Total|Total of all reporting groups
11161168|NCT01945294|FG000|Participant Flow|All Treated Participants|All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA]) or allocation to Arm 3 (participants with detectable HCV RNA).
11161169|NCT01945294|FG001|Participant Flow|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
11161170|NCT01945294|FG002|Participant Flow|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
11161171|NCT01945294|FG003|Participant Flow|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
11161172|NCT01945294|OG000|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
11161173|NCT01945294|OG001|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
11161174|NCT01945294|OG002|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
11161175|NCT01945294|OG002|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
11161176|NCT01945294|EG000|Reported Event|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
11161177|NCT01945294|EG001|Reported Event|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
11173986|NCT02018887|EG016|Reported Event|Part B: 80 mg LY2969822 BID|80 mg LY2969822 administered BID, PO, for 6 days.
11173987|NCT02018887|EG017|Reported Event|Part C: Placebo BID|Placebo administered BID, PO, for 14 days.
11161178|NCT01945294|EG002|Reported Event|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
11161179|NCT01945489|BG000|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
11161180|NCT01945489|BG001|Baseline|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
11161181|NCT01945489|BG002|Baseline|Total|Total of all reporting groups
11161182|NCT01945489|FG000|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
11161183|NCT01945489|FG001|Participant Flow|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
11161184|NCT01945489|OG000|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
11161185|NCT01945489|OG001|Outcome|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
11161186|NCT01945489|EG000|Reported Event|OnabotulinumtoxinA (Cycle 1)|OnabotulinumtoxinA (BOTOX®) 100 U injected into the detrusor at Day 1 in Cycle 1.
11161187|NCT01945489|EG001|Reported Event|Placebo (Cycle 1)|Placebo (Normal saline) injected into the detrusor on Day 1 of Cycle 1.
11161188|NCT01945489|EG002|Reported Event|OnabotulinumtoxinA (Cycle 2)|OnabotulinumtoxinA (BOTOX®) 100 U injected into the detrusor at Day 1 in Cycle 2.
11161189|NCT01945580|BG000|Baseline|Xenform|"Prolapse Repair with Xenform Soft Tissue Repair Matrix~Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair"
11161190|NCT01945580|BG001|Baseline|Control|"Prolapse Repair with Native Tissue Only~Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair"
11161191|NCT01945580|BG002|Baseline|Total|Total of all reporting groups
11161192|NCT01945580|FG000|Participant Flow|Xenform|"Prolapse Repair with Xenform Soft Tissue Repair Matrix~Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair"
11161193|NCT01945580|FG001|Participant Flow|Control|"Prolapse Repair with Native Tissue Only~Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair"
11161194|NCT01945580|OG000|Outcome|Xenform|"Prolapse Repair with Xenform Soft Tissue Repair Matrix~Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair"
11161195|NCT01945580|OG001|Outcome|Control|"Prolapse Repair with Native Tissue Only~Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair"
11161196|NCT01945580|OG000|Outcome|Total|Inclusive
11161197|NCT01945580|OG001|Outcome|Mild|Measure of Severity
11161198|NCT01945580|OG002|Outcome|Moderate|Measure of Severity
11161199|NCT01945580|OG003|Outcome|Severe|Measure of Severity
11161200|NCT01945580|EG000|Reported Event|Xenform|"Prolapse Repair with Xenform Soft Tissue Repair Matrix~Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair"
11161201|NCT01945580|EG001|Reported Event|Control|"Prolapse Repair with Native Tissue Only~Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair"
11161202|NCT01945593|BG000|Baseline|BAX 855: Age < 2 Years|Participants of age < 2 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161203|NCT01945593|BG001|Baseline|BAX 855: Age >= 2 to <12 Years|Participants of age >= 2 to <12 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161204|NCT01945593|BG002|Baseline|BAX 855: Age >= 12 to <17 Years|Participants of age >= 12 to <17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161205|NCT01945593|BG003|Baseline|BAX 855: Age >= 17 Years|Participants of age >= 17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161206|NCT01945593|BG004|Baseline|Total|Total of all reporting groups
11161207|NCT01945593|FG000|Participant Flow|BAX 855: Age < 2 Years|Participants of age less than (<) 2 years received an infusion of 50 +/- 10 International Units (IU)/kilogram (kg) of BAX 855 twice weekly; could be increased to 80 IU/kg or a pharmacokinetically tailored (PK-tailored) prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain Factor VIII (FVIII) trough levels of greater than or equal to (>=) 3% until at least 100 exposure days (EDs) were reached.
11161208|NCT01945593|FG001|Participant Flow|BAX 855: Age >= 2 to <12 Years|Participants of age >= 2 to <12 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11173988|NCT02018887|EG018|Reported Event|Part C: 6 mg LY2969822 BID|6 mg LY2969822 administered BID, PO, for 2 days.
11161209|NCT01945593|FG002|Participant Flow|BAX 855: Age >= 12 to <17 Years|Participants of age >= 12 to <17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161210|NCT01945593|FG003|Participant Flow|BAX 855: Age >= 17 Years|Participants of age >= 17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161211|NCT01945593|OG000|Outcome|BAX 855: Age < 2 Years|Participants of age < 2 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161212|NCT01945593|OG001|Outcome|BAX 855: Age >= 2 to <12 Years|Participants of age >= 2 to <12 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161213|NCT01945593|OG002|Outcome|BAX 855: Age >= 12 to <17 Years|Participants of age >= 12 to <17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161214|NCT01945593|OG003|Outcome|BAX 855: Age >= 17 Years|Participants of age >= 17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161215|NCT01945593|OG000|Outcome|BAX 855: Age >= 17 Years|Participants of age >= 17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161216|NCT01945593|OG000|Outcome|BAX 855: Age >= 12 to <17 Years|Participants of age >= 12 to <17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161217|NCT01945593|OG001|Outcome|BAX 855: Age >= 17 Years|Participants of age >= 17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161218|NCT01945593|OG000|Outcome|BAX 855: Age >= 2 to <12 Years|Participants of age >= 2 to <12 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161219|NCT01945593|OG001|Outcome|BAX 855: Age >= 12 to <17 Years|Participants of age >= 12 to <17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161220|NCT01945593|EG000|Reported Event|BAX 855: Age < 2 Years|Participants of age < 2 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161221|NCT01945593|EG001|Reported Event|BAX 855: Age >= 2 to <12 Years|Participants of age >= 2 to <12 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161222|NCT01945593|EG002|Reported Event|BAX 855: Age >= 12 to <17 Years|Participants of age >= 12 to <17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161223|NCT01945593|EG003|Reported Event|BAX 855: Age >= 17 Years|Participants of age >= 17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of >= 3% until at least 100 EDs were reached.
11161224|NCT01945710|BG000|Baseline|Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.0 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161225|NCT01945710|BG001|Baseline|Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.4 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11173989|NCT02018887|EG019|Reported Event|Part C: 10 mg LY2969822 BID|10 mg LY2969822 administered BID, PO, for 2 days.
11161226|NCT01945710|BG002|Baseline|Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161227|NCT01945710|BG003|Baseline|Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161228|NCT01945710|BG004|Baseline|Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161229|NCT01945710|BG005|Baseline|Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (2.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161230|NCT01945710|BG006|Baseline|Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Expansion Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
11161231|NCT01945710|BG007|Baseline|Total|Total of all reporting groups
11161232|NCT01945710|FG000|Participant Flow|Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.0 milligram per square meter [mg/m^2]) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161233|NCT01945710|FG001|Participant Flow|Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.4 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161234|NCT01945710|FG002|Participant Flow|Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161235|NCT01945710|FG003|Participant Flow|Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161236|NCT01945710|FG004|Participant Flow|Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161237|NCT01945710|FG005|Participant Flow|Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (2.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161238|NCT01945710|FG006|Participant Flow|Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Expansion Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
11161239|NCT01945710|OG000|Outcome|Schedule 1: Total Escalation Cohorts|Eribulin-LF (1.0 mg/m^2, 1.4 mg/m^2, or 1.5 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161240|NCT01945710|OG001|Outcome|Schedule 2: Total Dose Escalation and Expansion|"Dose Escalation Cohort: Eribulin-LF (1.0 mg/m^2, 1.5 mg/m^2, or 2.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.~Expansion Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle."
11161241|NCT01945710|OG000|Outcome|Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.0 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161242|NCT01945710|OG001|Outcome|Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.4 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161243|NCT01945710|OG002|Outcome|Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161244|NCT01945710|OG003|Outcome|Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161245|NCT01945710|OG004|Outcome|Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161246|NCT01945710|OG005|Outcome|Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (2.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161247|NCT01945710|OG006|Outcome|Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Expansion Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
11161248|NCT01945710|EG000|Reported Event|Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.0 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161249|NCT01945710|EG001|Reported Event|Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.4 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11173990|NCT02018887|EG020|Reported Event|Part C: 20 mg LY2969822 BID|20 mg LY2969822 administered BID, PO, for up to 10 days.
11173991|NCT02018887|EG021|Reported Event|Part C: 40 mg LY2969822 BID|40 mg LY2969822 administered BID, PO, for up to 8 days.
11161250|NCT01945710|EG002|Reported Event|Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161251|NCT01945710|EG003|Reported Event|Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161252|NCT01945710|EG004|Reported Event|Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161253|NCT01945710|EG005|Reported Event|Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF|Dose Escalation Cohort: Eribulin-LF (2.0 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m^2 escalating until intolerable toxicity, disease progression or death.
11161254|NCT01945710|EG006|Reported Event|Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF|Dose Expansion Cohort: Eribulin-LF (1.5 mg/m^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
11161255|NCT01945866|BG000|Baseline|Sham + Intravitreal Ranibizumab 0.3 mg|Sham and ranibizumab, 0.3 mg, injections
11161256|NCT01945866|BG001|Baseline|Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg|Combination of ranibizumab, 0.3 mg and intravitreous sustained dexamethasone drug-delivery system (Ozurdex; Allergan), 700 µg, injection
11161257|NCT01945866|BG002|Baseline|Total|Total of all reporting groups
11161258|NCT01945866|FG000|Participant Flow|Sham + Intravitreal Ranibizumab 0.3 mg|"Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria.~intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria~Sham injection: No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first."
11161259|NCT01945866|FG001|Participant Flow|Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg|"The initial intravitreal ranibizumab injection will be given on the day of randomization. The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first.~intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria. Dexamethasone intravitreal implant: The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ran"
11161260|NCT01945866|OG000|Outcome|Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg|"The initial intravitreal ranibizumab injection will be given on the day of randomization. The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first. Intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria~dexamethasone intravitreal implant: The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ran"
11161261|NCT01945866|OG001|Outcome|Sham + Intravitreal Ranibizumab 0.3 mg|"Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria.~intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria~Sham injection: No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first."
11161262|NCT01945866|EG000|Reported Event|Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg|"The initial intravitreal ranibizumab injection will be given on the day of randomization. The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first. Intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria~dexamethasone intravitreal implant: The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ran"
11173992|NCT02019069|BG000|Baseline|Liposomal Cytarabine-daunorubicin CPX-351|"1st INDUCTION: Patients receive liposomal cytarabine-daunorubicin CPX-351 IV at a dose of 65 units/m2/day over 90 minutes on days 1, 3, and 5.~2nd INDUCTION: Patients receive liposomal cytarabine-daunorubicin CPX-351 IV a dose of 65 units/m2/day over 90 minutes on days 1 and 3.~CONSOLIDATION: Beginning on day 28, patients receive liposomal cytarabine-daunorubicin CPX-351 IV a dose of 65 units/m2/day over 90 minutes on days 1 and 3.~liposomal cytarabine-daunorubicin CPX-351: Given IV"
11161263|NCT01945866|EG001|Reported Event|Sham + Intravitreal Ranibizumab 0.3 mg|"Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria.~intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria~Sham injection: No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first."
11161264|NCT01945866|EG002|Reported Event|Bilateral|Participants with one eye enrolled in each arm of the study. A participant could only have one eye in each arm/group, therefore participants in the bilateral group received Intravitreal dexamethasone+intravitreal ranibizumab 0.3mg in one eye and Sham + intravitreal ranibizumab 0.3 mg in the other eye.
11161265|NCT01945944|BG000|Baseline|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
11161266|NCT01945944|BG001|Baseline|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
11161267|NCT01945944|BG002|Baseline|Total|Total of all reporting groups
11161268|NCT01945944|FG000|Participant Flow|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
11161269|NCT01945944|FG001|Participant Flow|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
11161270|NCT01945944|OG000|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
11161271|NCT01945944|OG001|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
11161272|NCT01945944|OG000|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
11161273|NCT01945944|OG001|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
11161274|NCT01945944|EG000|Reported Event|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
11161275|NCT01945944|EG001|Reported Event|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
11161276|NCT01945970|BG000|Baseline|Study Subjects|All six treatment orders combined
11161277|NCT01945970|FG000|Participant Flow|Black Tea - Positive Control - Placebo|"Subjects treated in the order Black tea - wash out- Positive control - wash out - Placebo.~Treatments each lasted one week and were separated by a one week washout."
11161278|NCT01945970|FG001|Participant Flow|Black Tea - Placebo - Positive Control|"Subjects treated in the order Black tea - wash out- Placebo control - wash out - Positive control.~Treatments each lasted one week and were separated by a one week washout."
11161279|NCT01945970|FG002|Participant Flow|Positive Control - Black Tea - Placebo|"Subjects treated in the order Positive control - wash out - Black tea - wash out - Placebo.~Treatments each lasted one week and were separated by a one week washout."
11161280|NCT01945970|FG003|Participant Flow|Positive Control - Placebo - Black Tea|"Subjects treated in the order Positive control - wash out - Placebo - wash out - Black tea.~Treatments each lasted one week and were separated by a one week washout."
11161281|NCT01945970|FG004|Participant Flow|Placebo- Positive Control - Black Tea|"Subjects treated in the order Placebo - wash out - Positive control - wash out- Black tea.~Treatments each lasted one week and were separated by a one week washout."
11161282|NCT01945970|FG005|Participant Flow|Placebo - Black Tea - Positive Control|"Subjects treated in the order Placebo - wash out - Black tea - wash out- Positive control.~Treatments each lasted one week and were separated by a one week washout."
11161283|NCT01945970|OG000|Outcome|Black Tea Beverage|Participant when they received Back Tea
11161284|NCT01945970|OG001|Outcome|Placebo Beverage|Participants when the received Placebo
11161285|NCT01945970|OG000|Outcome|Black Tea Beverage|Participant when they received Back tea
11161286|NCT01945970|OG000|Outcome|Positive Control Beverage|Participant when they received the positive control
11161287|NCT01945970|OG000|Outcome|Postive Control Beverage|Participant when they received the positive control
11161288|NCT01945970|EG000|Reported Event|Black Tea Extract|Spray dried aqueous extract of a representative batch of black tea
11161289|NCT01945970|EG001|Reported Event|Positive Control|Spray dried aqueous extract of a batch of tea extract that has shown to improve Flow Mediated Dilation previously
11161290|NCT01945970|EG002|Reported Event|Placebo|Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract
11161291|NCT01945996|BG000|Baseline|TExT-MED Only|"Patients will receive TExT-MED intervention, but supporters will not receive additional messages~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone"
11161292|NCT01945996|BG001|Baseline|TExT-MED FANS|"Patients get TExT-MED intervention, supporter gets FANS curriculum~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone~FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges"
11161293|NCT01945996|BG002|Baseline|Total|Total of all reporting groups
11161294|NCT01945996|FG000|Participant Flow|TExT-MED Only|"Patients will receive TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes) intervention, but supporters will not receive additional messages~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone"
11161295|NCT01945996|FG001|Participant Flow|TExT-MED FANS|"Patients get TExT-MED intervention, supporter gets FANS curriculum (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes with Family And friends Network Supporters)~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone~FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges"
11161296|NCT01945996|OG000|Outcome|TExT-MED Only|"Patients will receive TExT-MED intervention, but supporters will not receive additional messages~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone"
11161297|NCT01945996|OG001|Outcome|TExT-MED FANS|"Patients get TExT-MED intervention, supporter gets FANS curriculum~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone~FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges"
11161298|NCT01945996|OG000|Outcome|TExT-MED Only|"Patients will receive TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes) intervention, but supporters will not receive additional messages~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone"
11161299|NCT01945996|OG001|Outcome|TExT-MED FANS|"Patients get TExT-MED intervention, supporter gets FANS curriculum (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes with Family And friends Network Supporters)~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone~FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges"
11161300|NCT01945996|EG000|Reported Event|TExT-MED Only|"Patients will receive TExT-MED intervention, but supporters will not receive additional messages~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone"
11161301|NCT01945996|EG001|Reported Event|TExT-MED FANS|"Patients get TExT-MED intervention, supporter gets FANS curriculum~TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone~FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges"
11161302|NCT01946126|BG000|Baseline|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
11161303|NCT01946126|BG001|Baseline|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
11161304|NCT01946126|BG002|Baseline|Total|Total of all reporting groups
11161305|NCT01946126|FG000|Participant Flow|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
11161306|NCT01946126|FG001|Participant Flow|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
11161307|NCT01946126|OG000|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
11161308|NCT01946126|OG001|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
11161309|NCT01946126|EG000|Reported Event|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
11161310|NCT01946126|EG001|Reported Event|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
11161311|NCT01946152|BG000|Baseline|Cohort 0|4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161312|NCT01946152|BG001|Baseline|Cohort I|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161313|NCT01946152|BG002|Baseline|Cohort II|6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161314|NCT01946152|BG003|Baseline|Maximum Tolerated Dose (MTD)|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161315|NCT01946152|BG004|Baseline|Total|Total of all reporting groups
11161316|NCT01946152|FG000|Participant Flow|Cohort 0|4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161317|NCT01946152|FG001|Participant Flow|Cohort I|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161318|NCT01946152|FG002|Participant Flow|Cohort II|6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161319|NCT01946152|FG003|Participant Flow|Maximum Tolerated Dose (MTD)|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161320|NCT01946152|OG000|Outcome|Maximum Tolerated Dose (MTD)|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161321|NCT01946152|OG000|Outcome|Cohort 0|4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161322|NCT01946152|OG001|Outcome|Cohort I|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161323|NCT01946152|OG002|Outcome|Cohort II|6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161324|NCT01946152|OG003|Outcome|Maximum Tolerated Dose (MTD)|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161325|NCT01946152|OG000|Outcome|Maximum Tolerated Dosage (MTD)|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161326|NCT01946152|EG000|Reported Event|Cohort 0|4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161327|NCT01946152|EG001|Reported Event|Cohort 1|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161328|NCT01946152|EG002|Reported Event|Cohort 2|6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11161329|NCT01946152|EG003|Reported Event|Maximum Tolerated Dose (MTD)|5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
11349180|NCT04114058|BG000|Baseline|Liposomal Bupivicaine|"Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control~liposomal bupivicaine: local field infiltration"
11161330|NCT01946165|BG000|Baseline|Group A: Abiraterone + Enzalutamide+ LHRHa+ Prednisone|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~Enzalutamide: 160 mg by mouth daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161331|NCT01946165|BG001|Baseline|Group B: Abiraterone+ LHRHa+ Prednisone|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161332|NCT01946165|BG002|Baseline|Total|Total of all reporting groups
11161333|NCT01946165|FG000|Participant Flow|Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone.|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~Enzalutamide: 160 mg by mouth daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161334|NCT01946165|FG001|Participant Flow|Group B: Abiraterone + LHRHa + Prednisone.|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161335|NCT01946165|OG000|Outcome|Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone.|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~Enzalutamide: 160 mg by mouth daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161336|NCT01946165|OG001|Outcome|Group B: Abiraterone + LHRHa + Prednisone|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161337|NCT01946165|OG000|Outcome|Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~Enzalutamide: 160 mg by mouth daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161338|NCT01946165|EG000|Reported Event|Arm A: Abiraterone + Enzalutamide + LHRHa + Prednisone|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~Enzalutamide: 160 mg by mouth daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161339|NCT01946165|EG001|Reported Event|Group B: Abiraterone + LHRHa + Prednisone|"Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.~Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.~Prednisone: 5 mg by mouth once daily for each 28 day cycle.~LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives."
11161340|NCT01946178|BG000|Baseline|All Treated Patients|All patients who underwent treatment with the device
11161341|NCT01946178|FG000|Participant Flow|All Treated Patients|All patients who underwent treatment with the device
11161342|NCT01946178|OG000|Outcome|All Treated Patients|All patients who underwent treatment with the device
11349181|NCT04114058|BG001|Baseline|Fascia Iliaca Blockade|"Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control~Fascia iliaca blockade: fascia iliaca compartment blockade"
11161343|NCT01946178|OG000|Outcome|Development Cohort With NPVs Observed|"The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 33 out of 37 patients (89.2%) in the Development Cohort with NPVs observed following treatment.~Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
11161344|NCT01946178|OG001|Outcome|Validation Cohort With NPVs Observed|"The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 35 out of 36 patients (97.2%) in the Validation Cohort with NPVs observed following treatment.~Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
11161345|NCT01946178|OG000|Outcome|Entire Development Cohort|The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 37 patients in the Development Cohort.
11161346|NCT01946178|OG001|Outcome|Entire Validation Cohort|The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 36 patients in the Validation Cohort.
11161347|NCT01946178|EG000|Reported Event|All Treated Patients|All patients who underwent treatment with the device
11161348|NCT01946191|BG000|Baseline|Coaching Group|"Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians~Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice~Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record~Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment"
11161349|NCT01946191|BG001|Baseline|Tracking Group|"Online self-monitoring~Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record"
11161350|NCT01946191|BG002|Baseline|Total|Total of all reporting groups
11161351|NCT01946191|FG000|Participant Flow|Continued Group|"24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts~Online self-monitoring~Real-time updates to primary care physicians"
11161352|NCT01946191|FG001|Participant Flow|Tracking Group|Online self-monitoring
11161353|NCT01946191|OG000|Outcome|Coaching Group|"Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians~Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice~Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record~Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment"
11161354|NCT01946191|OG001|Outcome|Tracking Group|"Online self-monitoring~Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record"
11161355|NCT01946191|OG000|Outcome|Continued Group|"Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians~Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice~Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record~Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment"
11161356|NCT01946191|EG000|Reported Event|Continued Group|"Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians~Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice~Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record~Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment"
11161357|NCT01946191|EG001|Reported Event|Tracking Group|"Online self-monitoring~Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record"
11161358|NCT01946243|BG000|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
11161359|NCT01946243|FG000|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
11161360|NCT01946243|OG000|Outcome|Qualitative|Qualitative scan interpretation only
11161361|NCT01946243|OG001|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
11161362|NCT01946243|OG002|Outcome|Change|Change = VisQ - Qualitative
11161363|NCT01946243|EG000|Reported Event|Florbetapir PET Scans|No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A07/A16 and A17).
11173993|NCT02019069|FG000|Participant Flow|Liposomal Cytarabine-daunorubicin CPX-351|"1st INDUCTION: Patients receive liposomal cytarabine-daunorubicin CPX-351 IV at a dose of 65 units/m2/day over 90 minutes on days 1, 3, and 5.~2nd INDUCTION: Patients receive liposomal cytarabine-daunorubicin CPX-351 IV a dose of 65 units/m2/day over 90 minutes on days 1 and 3.~CONSOLIDATION: Beginning on day 28, patients receive liposomal cytarabine-daunorubicin CPX-351 IV a dose of 65 units/m2/day over 90 minutes on days 1 and 3.~liposomal cytarabine-daunorubicin CPX-351: Given IV"
11349182|NCT04114058|BG002|Baseline|Total|Total of all reporting groups
11161364|NCT01946282|BG000|Baseline|FIT Invitation Only|"Fecal Immunochemical Test (FIT) mailed to patient homes free of charge. Fecal Immunochemical Test (FIT) kits and an invitation letter to complete colorectal cancer screening are mailed to the homes of study eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within one week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation.~Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3 consistent with guideline recommended annual FIT for colorectal cancer screening. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.~FIT Invitation Only: Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes."
11161365|NCT01946282|BG001|Baseline|FIT Plus $5 Incentive|"Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. FIT kits and invitation letter with a gift card incentive in one of two small dollar amounts to complete screening are mailed to the homes of 2000 (1000 per group) randomly assigned eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within one week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation.~Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.~FIT plus Incentive: Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes."
11161366|NCT01946282|BG002|Baseline|FIT Plus $10 Incentive|"Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. FIT kits and invitation letter with a gift card incentive in one of two small dollar amounts to complete screening are mailed to the homes of 2000 (1000 per group) randomly assigned eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within one week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation.~Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.~FIT plus Incentive: Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes."
11161367|NCT01946282|BG003|Baseline|Total|Total of all reporting groups
11161368|NCT01946282|FG000|Participant Flow|FIT Invitation Only, No Incentive|"Fecal Immunochemical Test (FIT) mailed to patient homes free of charge. Fecal Immunochemical Test (FIT) kits and an invitation letter to complete colorectal cancer screening are mailed to the homes of study eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within 1 week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation.~Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3 consistent with guideline recommended annual FIT for colorectal cancer screening. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy."
11161369|NCT01946282|FG001|Participant Flow|FIT Plus $5 Incentive|"Fecal Immunochemical Test (FIT) mailed to patient homes, plus an $5 gift card incentive to complete the test. FIT kits and invitation letter with a gift card incentive to complete screening are mailed to the homes of 1000 randomly assigned eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within 1 week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation.~Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy."
11161370|NCT01946282|FG002|Participant Flow|FIT Plus $10 Incentive|"Fecal Immunochemical Test (FIT) mailed to patient homes, plus an $10 gift card incentive to complete the test. FIT kits and invitation letter with a gift card incentive to complete screening are mailed to the homes of 1000 randomly assigned eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within 1 week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation.~Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy."
11161371|NCT01946282|OG000|Outcome|Standard Invite|"Fecal Immunochemical Test (FIT) kits and an invitation letter to complete colorectal cancer screening are mailed to the homes of study eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within one week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation."
11161372|NCT01946282|OG001|Outcome|Incentive Invite|The denominator population for evaluating baseline and end of Year 3 screening rates will consist of patients meeting the following criteria: 1) Age 50-64, 2) Uninsured, but participants in JPS's medical assistance program for the uninsured, 3) One or more visits to a JPS primary care clinic within a year, 4) Address and phone number on file, 5) No history of CRC or colon resection, 6) Not incarcerated
11161373|NCT01946282|OG000|Outcome|$5 Incentive Invitation|"Fecal Immunochemical Test (FIT) mailed to patient homes free of charge. Fecal Immunochemical Test (FIT) kits and an invitation letter to complete colorectal cancer screening are mailed to the homes of study eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within one week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation.~Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3 consistent with guideline recommended annual FIT for colorectal cancer screening. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy."
11349183|NCT04114058|FG000|Participant Flow|Liposomal Bupivicaine|"Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control~liposomal bupivicaine: local field infiltration"
11161374|NCT01946282|OG001|Outcome|$10 Incentive Invite|"Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. FIT kits and invitation letter with a gift card incentive in one of two small dollar amounts to complete screening are mailed to the homes of 2000 (1000 per group) randomly assigned eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within one week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation.~Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.~FIT plus Incentive: Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes."
11161375|NCT01946282|OG002|Outcome|Outreach Alone|The outreach included: (i) a mailed invitation to complete and return the FIT in English and Spanish; (ii) a 1-sample Polymedco OC Sensor FIT test; (iii) 2 automated telephone reminders in English and Spanish at the time invitations were mailed and 1 week later, encouraging test completion; and (iv) up to 2 live telephone reminders within 3 weeks of the invitation mailing, if the FIT was not returned or if the patient had not been reached during earlier attempts.
11161376|NCT01946282|EG000|Reported Event|FIT Invitation Only, No Incentive|"Fecal Immunochemical Test (FIT) mailed to patient homes free of charge. Fecal Immunochemical Test (FIT) kits and an invitation letter to complete colorectal cancer screening are mailed to the homes of study eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within 1 week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation."
11161377|NCT01946282|EG001|Reported Event|FIT Plus $5 Incentive|"Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. FIT kits and invitation letter with a gift card incentive in one of two small dollar amounts to complete screening are mailed to the homes of 2000 (1000 per group) randomly assigned eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within 1 week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation."
11161378|NCT01946282|EG002|Reported Event|FIT Plus $10 Incentive|"Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. FIT kits and invitation letter with a gift card incentive in one of two small dollar amounts to complete screening are mailed to the homes of 2000 (1000 per group) randomly assigned eligible patients. A postage paid return mailer is included. Automated and live phone call reminders are made at the time of invitation and within 1 week of invitation. Up to two live phone call reminders are attempted 2 to 3 weeks post invitation."
11161379|NCT01946412|BG000|Baseline|Ivacaftor|Participants received ivacaftor 50 mg or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered q12h for participants aged 2 to < 6 years and weighing <14 kg, ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing >= 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
11161380|NCT01946412|FG000|Participant Flow|Ivacaftor|Participants received ivacaftor 50 milligram (mg) or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered every 12 hours (q12h) for participants aged 2 to less than (<) 6 years and weighing <14 kilograms (kg), ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing greater than or equal to (>=) 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
11161381|NCT01946412|OG000|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
11161382|NCT01946412|OG001|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
11161383|NCT01946412|EG000|Reported Event|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
11161384|NCT01946412|EG001|Reported Event|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
11161385|NCT01946425|BG000|Baseline|Age 6 to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
11161386|NCT01946425|BG001|Baseline|Age 3 to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
11161387|NCT01946425|BG002|Baseline|Total|Total of all reporting groups
11161388|NCT01946425|FG000|Participant Flow|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
11161389|NCT01946425|FG001|Participant Flow|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
11161390|NCT01946425|OG000|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
11161391|NCT01946425|OG001|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
11161392|NCT01946425|OG001|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
11161393|NCT01946425|EG000|Reported Event|Age 6 Months to <36 Months Group|Participants 6 months to < 36 months of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
11161394|NCT01946425|EG001|Reported Event|Age 3 Years to <9 Years Group|Participants age 3 years to < 9 years of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
11161395|NCT01946438|BG000|Baseline|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161396|NCT01946438|BG001|Baseline|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
11161397|NCT01946438|BG002|Baseline|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161398|NCT01946438|BG003|Baseline|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161399|NCT01946438|BG004|Baseline|Total|Total of all reporting groups
11161400|NCT01946438|FG000|Participant Flow|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161401|NCT01946438|FG001|Participant Flow|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
11161402|NCT01946438|FG002|Participant Flow|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161403|NCT01946438|FG003|Participant Flow|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161404|NCT01946438|OG000|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161405|NCT01946438|OG001|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
11161406|NCT01946438|OG002|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161407|NCT01946438|OG003|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161408|NCT01946438|OG000|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Vaccine 2013-2014 formulation
11161409|NCT01946438|OG003|Outcome|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161410|NCT01946438|OG000|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161411|NCT01946438|OG001|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
11161412|NCT01946438|OG002|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161413|NCT01946438|OG003|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161414|NCT01946438|EG000|Reported Event|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161415|NCT01946438|EG001|Reported Event|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
11161416|NCT01946438|EG002|Reported Event|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161417|NCT01946438|EG003|Reported Event|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
11161418|NCT01946529|BG000|Baseline|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
11161419|NCT01946529|BG001|Baseline|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
11161420|NCT01946529|BG002|Baseline|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
11161421|NCT01946529|BG003|Baseline|Total|Total of all reporting groups
11161422|NCT01946529|FG000|Participant Flow|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
11161423|NCT01946529|FG001|Participant Flow|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
11161424|NCT01946529|FG002|Participant Flow|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
11161425|NCT01946529|OG000|Outcome|Group B (High Risk) - ESFT|Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation.
11161426|NCT01946529|EG000|Reported Event|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
11161427|NCT01946529|EG001|Reported Event|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
11161428|NCT01946529|EG002|Reported Event|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
11161429|NCT01946529|EG003|Reported Event|Group B (High Risk) - Total|"All Group B High Risk participants with ESFT or DSRCT.~Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation."
11161430|NCT01946802|BG000|Baseline|Frontal 4 Channel EEG|"Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic out-of-hospital and in-hospital cardiac arrest.~Frontal 4 channel EEG: Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia"
11161431|NCT01946802|FG000|Participant Flow|Frontal 4 Channel EEG|Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic cardiac arrest.
11161432|NCT01946802|OG000|Outcome|Frontal 4 Channel EEG|Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic out-of-hospital and in-hospital cardiac arrest.
11161433|NCT01946802|EG000|Reported Event|Frontal 4 Channel EEG|"Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic out-of-hospital and in-hospital cardiac arrest.~Frontal 4 channel EEG: Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia"
11161434|NCT01946880|BG000|Baseline|Maintenance|Participants received Mycophenolate Mofetil (MMF) treatment (1000-3000 mg/day) for the rest of their study participation (up to Week 60).
11161435|NCT01946880|BG001|Baseline|Withdrawal|Participants tapered off Mycophenolate Mofetil (MMF) per the protocol-specified schedule over 12 weeks and remained off MMF for the rest of their study participation (up to Week 60 or until the primary endpoint of disease reactivation was met, whichever came first).
11161436|NCT01946880|BG002|Baseline|Total|Total of all reporting groups
11161437|NCT01946880|FG000|Participant Flow|MMF Maintenance|Participants received Mycophenolate Mofetil (MMF) treatment (1000-3000 mg/day) for the rest of their study participation (up to Week 60).
11161438|NCT01946880|FG001|Participant Flow|MMF Withdrawal|Participants tapered off Mycophenolate Mofetil (MMF) per the protocol-specified schedule over 12 weeks and remained off MMF for the rest of their study participation (up to Week 60 or until the primary endpoint of disease reactivation was met, whichever came first).
11161439|NCT01946880|OG000|Outcome|MMF Maintenance|Participants received Mycophenolate Mofetil (MMF) treatment (1000-3000 mg/day) for the rest of their study participation (up to Week 60).
11161440|NCT01946880|OG001|Outcome|MMF Withdrawal|Participants tapered off Mycophenolate Mofetil (MMF) per the protocol-specified schedule over 12 weeks and remained off MMF for the rest of their study participation (up to Week 60 or until the primary endpoint of disease reactivation was met, whichever came first).
11161441|NCT01946880|EG000|Reported Event|Maintenance|Participants received Mycophenolate Mofetil (MMF) treatment (1000-3000 mg/day) for the rest of their study participation (up to Week 60).
11161442|NCT01946880|EG001|Reported Event|Withdrawal|Participants tapered off Mycophenolate Mofetil (MMF) per the protocol-specified schedule over 12 weeks and remained off MMF for the rest of their study participation (up to Week 60 or until the primary endpoint of disease reactivation was met, whichever came first).
11161443|NCT01947127|BG000|Baseline|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
11161444|NCT01947127|BG001|Baseline|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
11161445|NCT01947127|BG002|Baseline|Total|Total of all reporting groups
11161446|NCT01947127|FG000|Participant Flow|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
11161447|NCT01947127|FG001|Participant Flow|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
11161448|NCT01947127|OG000|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
11161449|NCT01947127|OG001|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
11161450|NCT01947127|EG000|Reported Event|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
11161451|NCT01947127|EG001|Reported Event|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
11161452|NCT01947153|BG000|Baseline|All Subjects|All subjects treated with 5 mg linagliptin / 1000 mg metformin as fixed dose combination or as free dose combination.
11161453|NCT01947153|FG000|Participant Flow|Fixed Dose Combination First, Then Free Combination|5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets first; then free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet
11161454|NCT01947153|FG001|Participant Flow|Free Combination First, Then Fixed Dose Combination|Free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet first; then 5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets
11161455|NCT01947153|OG000|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
11161456|NCT01947153|OG001|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
11161457|NCT01947153|EG000|Reported Event|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
11161458|NCT01947153|EG001|Reported Event|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
11161459|NCT01947283|BG000|Baseline|Intervention Providers & Patients|"Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.~For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161460|NCT01947283|BG001|Baseline|Intervention Patients, Control Providers|"Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.~These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.~For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers."
11161461|NCT01947283|BG002|Baseline|Control Patients, Intervention Providers|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161462|NCT01947283|BG003|Baseline|Control Patients & Providers|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care."
11161463|NCT01947283|BG004|Baseline|Non Randomized Controlled Trial Patients|Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.
11161464|NCT01947283|BG005|Baseline|Control Providers|Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.
11161465|NCT01947283|BG006|Baseline|Intervention Providers|Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
11161466|NCT01947283|BG007|Baseline|Total|Total of all reporting groups
11161467|NCT01947283|FG000|Participant Flow|Intervention Patients & Providers|"Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.~For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161468|NCT01947283|FG001|Participant Flow|Intervention Patients, Control Providers|"Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.~These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.~For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers."
11161469|NCT01947283|FG002|Participant Flow|Control Patients, Intervention Providers|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161470|NCT01947283|FG003|Participant Flow|Control Patients & Providers|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care."
11161471|NCT01947283|FG004|Participant Flow|Non Randomized Controlled Trial Patients|Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.
11161472|NCT01947283|FG005|Participant Flow|Control Providers|Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.
11161473|NCT01947283|FG006|Participant Flow|Intervention Providers|Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
11161474|NCT01947283|OG000|Outcome|Intervention Patients & Providers|"Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.~For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161475|NCT01947283|OG001|Outcome|Intervention Patients, Control Providers|"Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.~These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.~For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers."
11161476|NCT01947283|OG002|Outcome|Control Patients, Intervention Providers|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161477|NCT01947283|OG003|Outcome|Control Patients & Providers|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care."
11161478|NCT01947283|OG004|Outcome|Non Randomized Controlled Trial Patients|Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.
11161479|NCT01947283|OG005|Outcome|Control Providers|Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.
11161480|NCT01947283|OG006|Outcome|Intervention Providers|Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
11161481|NCT01947283|OG002|Outcome|Intervention Providers, Control Patients|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161482|NCT01947283|EG000|Reported Event|Intervention Patients & Providers|"Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.~For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161483|NCT01947283|EG001|Reported Event|Intervention Patients, Control Providers|"Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.~These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.~For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers."
11161484|NCT01947283|EG002|Reported Event|Control Patients, Intervention Providers|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making."
11161485|NCT01947283|EG003|Reported Event|Control Patients & Providers|"Participants in this arm are control patients who will not receive the DECIDE-PA intervention.~These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.~Control patients will receive a pamphlet called Managing Your Mental Health Care."
11161486|NCT01947283|EG004|Reported Event|Non-Randomized Controlled Trial Patients|Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.
11161487|NCT01947283|EG005|Reported Event|Control Providers|Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.
11161488|NCT01947283|EG006|Reported Event|Intervention Providers|Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
11161489|NCT01947335|BG000|Baseline|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
11161490|NCT01947335|BG001|Baseline|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
11161491|NCT01947335|BG002|Baseline|Total|Total of all reporting groups
11161492|NCT01947335|FG000|Participant Flow|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
11161493|NCT01947335|FG001|Participant Flow|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
11161494|NCT01947335|OG000|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
11161495|NCT01947335|OG001|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
11161496|NCT01947335|EG000|Reported Event|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
11161497|NCT01947335|EG001|Reported Event|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
11161498|NCT01947491|BG000|Baseline|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
11161499|NCT01947491|BG001|Baseline|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
11161500|NCT01947491|BG002|Baseline|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
11161501|NCT01947491|BG003|Baseline|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
11161502|NCT01947491|BG004|Baseline|Total|Total of all reporting groups
11161503|NCT01947491|FG000|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
11161504|NCT01947491|FG001|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
11161505|NCT01947491|FG002|Participant Flow|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
11161506|NCT01947491|FG003|Participant Flow|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
11161507|NCT01947491|OG000|Outcome|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
11161508|NCT01947491|OG001|Outcome|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
11161509|NCT01947491|OG002|Outcome|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
11161510|NCT01947491|OG003|Outcome|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
11161511|NCT01947491|EG000|Reported Event|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
11161512|NCT01947491|EG001|Reported Event|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
11161513|NCT01947491|EG002|Reported Event|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
11161514|NCT01947491|EG003|Reported Event|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
11161515|NCT01947517|BG000|Baseline|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
11161516|NCT01947517|BG001|Baseline|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
11161517|NCT01947517|BG002|Baseline|Total|Total of all reporting groups
11161518|NCT01947517|FG000|Participant Flow|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
11161519|NCT01947517|FG001|Participant Flow|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
11161520|NCT01947517|OG000|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
11161521|NCT01947517|OG001|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
11161522|NCT01947517|EG000|Reported Event|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
11161523|NCT01947517|EG001|Reported Event|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
11161524|NCT01947582|BG000|Baseline|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
11161525|NCT01947582|FG000|Participant Flow|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
11161526|NCT01947582|OG000|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
11161527|NCT01947582|EG000|Reported Event|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
11161528|NCT01947647|BG000|Baseline|Transdiagnostic Behavior Therapy|Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety
11161529|NCT01947647|BG001|Baseline|Behavioral Activation|Behavioral Activation is a 12-week psychotherapy for symptoms of depression
11161530|NCT01947647|BG002|Baseline|Total|Total of all reporting groups
11161531|NCT01947647|FG000|Participant Flow|Transdiagnostic Behavior Therapy|Transdiagnostic Behavior Therapy, a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety.
11161532|NCT01947647|FG001|Participant Flow|Behavioral Activation|Behavioral Activation, a 12-week psychotherapy for depressive symptoms
11161533|NCT01947647|OG000|Outcome|Transdiagnostic Behavior Therapy|Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety
11161534|NCT01947647|OG001|Outcome|Behavioral Activation|Behavioral Activation is a 12-week psychotherapy for symptoms of depression
11161535|NCT01947647|EG000|Reported Event|Transdiagnostic Behavior Therapy|Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety
11161536|NCT01947647|EG001|Reported Event|Behavioral Activation|Behavioral Activation is a 12-week psychotherapy for symptoms of depression
11161537|NCT01947816|BG000|Baseline|Humira|Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
11161538|NCT01947816|FG000|Participant Flow|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
11161539|NCT01947816|OG000|Outcome|Humira|Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
11161540|NCT01947816|EG000|Reported Event|Humira|Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
11161541|NCT01947855|BG000|Baseline|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
11161542|NCT01947855|BG001|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
11161543|NCT01947855|BG002|Baseline|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
11161544|NCT01947855|BG003|Baseline|Total|Total of all reporting groups
11161545|NCT01947855|FG000|Participant Flow|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
11161546|NCT01947855|FG001|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
11161547|NCT01947855|FG002|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
11161548|NCT01947855|OG000|Outcome|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
11161549|NCT01947855|OG001|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
11161550|NCT01947855|OG002|Outcome|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
11161551|NCT01947855|EG000|Reported Event|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
11161552|NCT01947855|EG001|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
11161553|NCT01947855|EG002|Reported Event|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
11161554|NCT01947894|BG000|Baseline|KIMS Adult Onset Growth Hormone Deficiency (GHD)|Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.
11161555|NCT01947894|BG001|Baseline|Naive Adult Onset GHD|Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.
11161556|NCT01947894|BG002|Baseline|Childhood Onset Growth Hormone Deficiency (CO-GHD)|Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.
11161557|NCT01947894|BG003|Baseline|Total|Total of all reporting groups
11161558|NCT01947894|FG000|Participant Flow|KIMS Adult Onset Growth Hormone Deficiency (GHD)|Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.
11161559|NCT01947894|FG001|Participant Flow|Naive Adult Onset GHD|Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.
11161560|NCT01947894|FG002|Participant Flow|Childhood Onset Growth Hormone Deficiency (CO-GHD)|Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.
11161561|NCT01947894|OG000|Outcome|KIMS Adult Onset Growth Hormone Deficiency (GHD)|Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.
11161562|NCT01947894|OG001|Outcome|Naive Adult Onset GHD|Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.
11161563|NCT01947894|OG002|Outcome|Childhood Onset Growth Hormone Deficiency (CO-GHD)|Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.
11349184|NCT04114058|FG001|Participant Flow|Fascia Iliaca Blockade|"Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control~Fascia iliaca blockade: fascia iliaca compartment blockade"
11161564|NCT01947894|EG000|Reported Event|KIMS Adult Onset Growth Hormone Deficiency (GHD)|Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012.
11161565|NCT01947894|EG001|Reported Event|Naive Adult Onset GHD|Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.
11161566|NCT01947894|EG002|Reported Event|Childhood Onset Growth Hormone Deficiency (CO-GHD)|Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study.
11161567|NCT01947907|BG000|Baseline|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161568|NCT01947907|BG001|Baseline|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161569|NCT01947907|BG002|Baseline|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161570|NCT01947907|BG003|Baseline|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
11161571|NCT01947907|BG004|Baseline|Total|Total of all reporting groups
11161572|NCT01947907|FG000|Participant Flow|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161573|NCT01947907|FG001|Participant Flow|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161574|NCT01947907|FG002|Participant Flow|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161575|NCT01947907|FG003|Participant Flow|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
11161576|NCT01947907|OG000|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161577|NCT01947907|OG001|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161578|NCT01947907|OG002|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161579|NCT01947907|OG003|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
11161580|NCT01947907|EG000|Reported Event|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161581|NCT01947907|EG001|Reported Event|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161582|NCT01947907|EG002|Reported Event|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
11161583|NCT01947907|EG003|Reported Event|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
11161584|NCT01947946|BG000|Baseline|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
11161585|NCT01947946|BG001|Baseline|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
11161586|NCT01947946|BG002|Baseline|Placebo|A (Dummy) injection
11161587|NCT01947946|BG003|Baseline|Total|Total of all reporting groups
11161588|NCT01947946|FG000|Participant Flow|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
11161589|NCT01947946|FG001|Participant Flow|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
11161590|NCT01947946|FG002|Participant Flow|Placebo|A (Dummy) injection
11161591|NCT01947946|OG000|Outcome|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
11161592|NCT01947946|OG001|Outcome|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
11161593|NCT01947946|OG002|Outcome|Placebo|A (Dummy) injection
11161594|NCT01947946|EG000|Reported Event|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
11161595|NCT01947946|EG001|Reported Event|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
11161596|NCT01947946|EG002|Reported Event|Placebo|A (Dummy) injection
11161597|NCT01948050|BG000|Baseline|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
11161598|NCT01948050|BG001|Baseline|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
11161599|NCT01948050|BG002|Baseline|Total|Total of all reporting groups
11161600|NCT01948050|FG000|Participant Flow|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
11349185|NCT04114058|OG000|Outcome|Liposomal Bupivicaine|"Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control~liposomal bupivicaine: local field infiltration"
11161601|NCT01948050|FG001|Participant Flow|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
11161602|NCT01948050|OG000|Outcome|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
11161603|NCT01948050|OG001|Outcome|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
11161604|NCT01948050|EG000|Reported Event|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
11161605|NCT01948050|EG001|Reported Event|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
11161606|NCT01948063|BG000|Baseline|Placebo|Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
11161607|NCT01948063|BG001|Baseline|Ubiquinol|Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
11161608|NCT01948063|BG002|Baseline|Total|Total of all reporting groups
11161609|NCT01948063|FG000|Participant Flow|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
11161610|NCT01948063|FG001|Participant Flow|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
11161611|NCT01948063|OG000|Outcome|Placebo|Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
11161612|NCT01948063|OG001|Outcome|Ubiquinol|Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
11161613|NCT01948063|EG000|Reported Event|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
11161614|NCT01948063|EG001|Reported Event|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
11161615|NCT01948076|BG000|Baseline|Resident Without GE Vscan|baseline physical exam use
11161616|NCT01948076|BG001|Baseline|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
11161617|NCT01948076|BG002|Baseline|Total|Total of all reporting groups
11161618|NCT01948076|FG000|Participant Flow|Control Group|Performed only physical exam with no access to ultrasoun
11161619|NCT01948076|FG001|Participant Flow|Intervention Group|Received training and access to ultrasounds. During assessment performed physical exam first followed by ultrasound exam
11161620|NCT01948076|OG000|Outcome|Resident Without GE Vscan|baseline physical exam use
11161621|NCT01948076|OG001|Outcome|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
11161622|NCT01948076|OG000|Outcome|Intervention Group (Using Physical Exam Only)|Baseline physical exam prior to using the ultrasound
11161623|NCT01948076|OG001|Outcome|Intervention Group (Using Ultrasound)|residents with augmentation of physical exam by ultrasound
11161624|NCT01948076|EG000|Reported Event|Resident Without GE Vscan|baseline physical exam use
11161625|NCT01948076|EG001|Reported Event|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
11161626|NCT01948141|BG000|Baseline|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
11161627|NCT01948141|FG000|Participant Flow|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
11161628|NCT01948141|OG000|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
11161629|NCT01948141|EG000|Reported Event|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
11161630|NCT01948193|BG000|Baseline|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
11161631|NCT01948193|FG000|Participant Flow|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
11161632|NCT01948193|OG000|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
11161633|NCT01948193|OG000|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
11161634|NCT01948193|EG000|Reported Event|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
11161635|NCT01948258|BG000|Baseline|Fertility Monitor|Use of Clearblue Fertility Monitor
11161636|NCT01948258|FG000|Participant Flow|Fertility Monitor|Use of Clearblue Advanced Fertility Monitor
11161637|NCT01948258|OG000|Outcome|Fertility Monitor|Use of Clearblue Fertility Monitor
11161638|NCT01948258|EG000|Reported Event|Fertility Monitor|Use of Clearblue Fertility Monitor
11161639|NCT01948310|BG000|Baseline|Placebo Plus Exercise|"Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)~Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day"
11161640|NCT01948310|BG001|Baseline|Ranolazine Plus Exercise|"Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)"
11161641|NCT01948310|BG002|Baseline|Total|Total of all reporting groups
11161642|NCT01948310|FG000|Participant Flow|Placebo Plus Exercise|"Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)~Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day"
11161643|NCT01948310|FG001|Participant Flow|Ranolazine Plus Exercise|"Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)"
11161644|NCT01948310|OG000|Outcome|Placebo Plus Exercise|Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
11161645|NCT01948310|OG001|Outcome|Ranolazine Plus Exercise|Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
11161646|NCT01948310|EG000|Reported Event|Ranolazine Plus Exercise|"Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)"
11161647|NCT01948310|EG001|Reported Event|Placebo Plus Exercise|"Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)~Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day"
11161648|NCT01948375|BG000|Baseline|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
11161649|NCT01948375|BG001|Baseline|Real Needle - Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
11161650|NCT01948375|BG002|Baseline|Total|Total of all reporting groups
11173994|NCT02019069|OG000|Outcome|Liposomal Cytarabine-daunorubicin CPX-351|"1st INDUCTION: Patients receive liposomal cytarabine-daunorubicin CPX-351 IV at a dose of 65 units/m2/day over 90 minutes on days 1, 3, and 5.~2nd INDUCTION: Patients receive liposomal cytarabine-daunorubicin CPX-351 IV a dose of 65 units/m2/day over 90 minutes on days 1 and 3.~CONSOLIDATION: Beginning on day 28, patients receive liposomal cytarabine-daunorubicin CPX-351 IV a dose of 65 units/m2/day over 90 minutes on days 1 and 3.~liposomal cytarabine-daunorubicin CPX-351: Given IV"
11349186|NCT04114058|OG001|Outcome|Fascia Iliaca Blockade|"Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control~Fascia iliaca blockade: fascia iliaca compartment blockade"
11161651|NCT01948375|FG000|Participant Flow|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.~real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
11161652|NCT01948375|FG001|Participant Flow|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.~placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
11161653|NCT01948375|OG000|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
11161654|NCT01948375|OG001|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
11161655|NCT01948375|OG000|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~placebo needle - real needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
11161656|NCT01948375|OG001|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~real needle- placebo needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
11161657|NCT01948375|EG000|Reported Event|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.~real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
11173995|NCT02019069|EG000|Reported Event|Liposomal Cytarabine-daunorubicin CPX-351|"1st INDUCTION: Patients receive liposomal cytarabine-daunorubicin CPX-351 IV at a dose of 65 units/m2/day over 90 minutes on days 1, 3, and 5.~2nd INDUCTION: Patients receive liposomal cytarabine-daunorubicin CPX-351 IV a dose of 65 units/m2/day over 90 minutes on days 1 and 3.~CONSOLIDATION: Beginning on day 28, patients receive liposomal cytarabine-daunorubicin CPX-351 IV a dose of 65 units/m2/day over 90 minutes on days 1 and 3.~liposomal cytarabine-daunorubicin CPX-351: Given IV"
11349187|NCT04114058|EG000|Reported Event|Liposomal Bupivicaine|"Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control~liposomal bupivicaine: local field infiltration"
11161658|NCT01948375|EG001|Reported Event|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.~placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
11161659|NCT01948388|BG000|Baseline|Corticotrophin 80 Units|"Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) weekly~corticotrophin 80 units: Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin"
11161660|NCT01948388|BG001|Baseline|Corticotrophin 80 Units Twice a Week|"Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) twice a week~corticotrophin 80 units: Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin"
11161661|NCT01948388|BG002|Baseline|Total|Total of all reporting groups
11161662|NCT01948388|FG000|Participant Flow|Group 1|Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
11161663|NCT01948388|FG001|Participant Flow|Group 2|Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
11161664|NCT01948388|OG000|Outcome|Group 1|Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
11161665|NCT01948388|OG001|Outcome|Group 2|Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
11161666|NCT01948388|OG000|Outcome|Group 1|Patients being weekly dosed with ACTH at 80 units
11161667|NCT01948388|OG001|Outcome|Group 2|Patients receiving twice weekly doing of 80 units ACTH
11161668|NCT01948388|EG000|Reported Event|Group 1|Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
11161669|NCT01948388|EG001|Reported Event|Group 2|Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
11161670|NCT01948427|BG000|Baseline|Sodium Phenylbutyrate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate at Baseline.
11161671|NCT01948427|BG001|Baseline|Ravicti|Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti at Baseline.
11161672|NCT01948427|BG002|Baseline|Sodium Benzoate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate at Baseline.
11161673|NCT01948427|BG003|Baseline|Carglumic Acid|Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid at Baseline.
11161674|NCT01948427|BG004|Baseline|Other|Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication at Baseline.
11161675|NCT01948427|BG005|Baseline|Total|Total of all reporting groups
11161676|NCT01948427|FG000|Participant Flow|Sodium Phenylbutyrate|Participants with a confirmed or suspected diagnosis of urea cycle disorder (UCD) receiving sodium phenylbutyrate at Baseline.
11161677|NCT01948427|FG001|Participant Flow|Ravicti|Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti at Baseline.
11161678|NCT01948427|FG002|Participant Flow|Sodium Benzoate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate at Baseline.
11161679|NCT01948427|FG003|Participant Flow|Carglumic Acid|Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid at Baseline.
11161680|NCT01948427|FG004|Participant Flow|Other|Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication at Baseline.
11161681|NCT01948427|OG000|Outcome|Sodium Phenylbutyrate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate.
11161682|NCT01948427|OG001|Outcome|Ravicti|Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti.
11161683|NCT01948427|OG002|Outcome|Sodium Benzoate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate.
11161684|NCT01948427|OG003|Outcome|Carglumic Acid|Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid.
11161685|NCT01948427|OG004|Outcome|Other|Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication.
11161686|NCT01948427|OG000|Outcome|Sodium Phenylbutyrate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate at Baseline.
11161687|NCT01948427|OG001|Outcome|Ravicti|Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti at Baseline.
11161688|NCT01948427|OG002|Outcome|Sodium Benzoate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate at Baseline.
11161689|NCT01948427|OG003|Outcome|Carglumic Acid|Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid at Baseline.
11161690|NCT01948427|OG004|Outcome|Other|Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication at Baseline.
11161691|NCT01948427|EG000|Reported Event|Sodium Phenylbutyrate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium phenylbutyrate at Baseline.
11161692|NCT01948427|EG001|Reported Event|Ravicti|Participants with a confirmed or suspected diagnosis of UCD receiving Ravicti at Baseline.
11161693|NCT01948427|EG002|Reported Event|Sodium Benzoate|Participants with a confirmed or suspected diagnosis of UCD receiving sodium benzoate at Baseline.
11161694|NCT01948427|EG003|Reported Event|Carglumic Acid|Participants with a confirmed or suspected diagnosis of UCD receiving carglumic acid at Baseline.
11161695|NCT01948427|EG004|Reported Event|Other|Participants with a confirmed or suspected diagnosis of UCD receiving other (not specified) ammonia-scavenging medication at Baseline.
11161696|NCT01948518|BG000|Baseline|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
11161697|NCT01948518|FG000|Participant Flow|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
11161698|NCT01948518|OG000|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
11161699|NCT01948518|EG000|Reported Event|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
11161700|NCT01948739|BG000|Baseline|BMI Control of MAHI Exo-II|"MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.~MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period."
11161701|NCT01948739|FG000|Participant Flow|BMI Control of MAHI Exo-II|"MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.~MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period."
11161702|NCT01948739|OG000|Outcome|BMI Control of MAHI Exo-II|"MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.~MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period."
11161703|NCT01948739|EG000|Reported Event|BMI Control of MAHI Exo-II|"MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.~MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period."
11161704|NCT01948791|BG000|Baseline|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
11161705|NCT01948791|FG000|Participant Flow|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
11161706|NCT01948791|OG000|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
11161707|NCT01948791|EG000|Reported Event|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
11161708|NCT01948830|BG000|Baseline|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
11161709|NCT01948830|BG001|Baseline|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
11161710|NCT01948830|BG002|Baseline|Total|Total of all reporting groups
11161711|NCT01948830|FG000|Participant Flow|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
11161712|NCT01948830|FG001|Participant Flow|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
11161713|NCT01948830|OG000|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
11161714|NCT01948830|OG001|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
11161715|NCT01948830|EG000|Reported Event|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
11161716|NCT01948830|EG001|Reported Event|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
11161717|NCT01948908|BG000|Baseline|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161718|NCT01948908|BG001|Baseline|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161719|NCT01948908|BG002|Baseline|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161720|NCT01948908|BG003|Baseline|Total|Total of all reporting groups
11161721|NCT01948908|FG000|Participant Flow|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161722|NCT01948908|FG001|Participant Flow|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161723|NCT01948908|FG002|Participant Flow|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161724|NCT01948908|OG000|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161725|NCT01948908|OG001|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161726|NCT01948908|OG002|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161727|NCT01948908|EG000|Reported Event|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161728|NCT01948908|EG001|Reported Event|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161729|NCT01948908|EG002|Reported Event|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
11161730|NCT01948947|BG000|Baseline|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
11161731|NCT01948947|BG001|Baseline|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
11161732|NCT01948947|BG002|Baseline|Total|Total of all reporting groups
11161733|NCT01948947|FG000|Participant Flow|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
11161734|NCT01948947|FG001|Participant Flow|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
11161735|NCT01948947|OG000|Outcome|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
10887774|NCT00502671|FG000|Participant Flow|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
11161736|NCT01948947|OG001|Outcome|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
11161737|NCT01948947|EG000|Reported Event|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
11161738|NCT01948947|EG001|Reported Event|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
11161739|NCT01948986|BG000|Baseline|Ertugliflozin 15 mg (T2DM With Normal Renal Function)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with normal renal function
11161740|NCT01948986|BG001|Baseline|Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
11161741|NCT01948986|BG002|Baseline|Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
11161742|NCT01948986|BG003|Baseline|Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
11161743|NCT01948986|BG004|Baseline|Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)|Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
11161744|NCT01948986|BG005|Baseline|Total|Total of all reporting groups
11161745|NCT01948986|FG000|Participant Flow|Ertugliflozin 15 mg (T2DM With Normal Renal Function)|Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
11161746|NCT01948986|FG001|Participant Flow|Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
11161747|NCT01948986|FG002|Participant Flow|Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
11161748|NCT01948986|FG003|Participant Flow|Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
11161749|NCT01948986|FG004|Participant Flow|Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)|Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
11161750|NCT01948986|OG000|Outcome|Ertugliflozin 15 mg (T2DM With Normal Renal Function)|Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
11161751|NCT01948986|OG001|Outcome|Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
11161752|NCT01948986|OG002|Outcome|Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
11161753|NCT01948986|OG003|Outcome|Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
11161754|NCT01948986|OG004|Outcome|Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)|Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
11161755|NCT01948986|EG000|Reported Event|T2DM Normal Renal Function|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with normal renal function
11161756|NCT01948986|EG001|Reported Event|T2DM Mild Renal Impairment|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
11161757|NCT01948986|EG002|Reported Event|T2DM Moderate Renal Impairment|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
11161758|NCT01948986|EG003|Reported Event|T2DM Severe Renal Impairment|Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
11161759|NCT01948986|EG004|Reported Event|Healthy Normal Renal Function|Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
11161760|NCT01949051|BG000|Baseline|Placebo/Levocabastine|Participants received placebo/ Levo at a dose of 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) into each nostril or 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days each, in a crossover design. Treatment was given in one of six sequences in Periods 1, 2, and 3, (14 to 20 day washout period between treatments): ABC, BCA, CAB, ACB, BAC, CBA (A, Levo 200µg; B, Levo 400µg: C, Placebo). On Day 8 of each treatment period (approximately 12 hours post dosing for treatment A and 24 hours post dosing for treatment B and C), participants entered the environmental exposure chamber (EEC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit within 7 to 14 day after their final dose, and the overall duration for participation in the study (screening to follow-up) was 13 weeks.
11161761|NCT01949051|FG000|Participant Flow|Sequence 1: Levo 200 µg, Levo 400µg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), Levo 400µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg once daily (OD) in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg twice daily (BID) in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
11161762|NCT01949051|FG001|Participant Flow|Sequence 2: Levo 400µg, Placebo and Levo 200µg|Participants received Levo 400µg, placebo and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
11161763|NCT01949051|FG002|Participant Flow|Sequence 3: Placebo, Levo 200µg and Levo 400µg|Participants received placebo, Levo 200µg and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
11161764|NCT01949051|FG003|Participant Flow|Sequence 4: Levo 200µg, Placebo, and Levo 400µg|Participants received Levo 200µg, placebo, and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
11161765|NCT01949051|FG004|Participant Flow|Sequence 5: Levo 400µg, Levo 200µg and Placebo|Participants received Levo 400µg, Levo 200µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
11161766|NCT01949051|FG005|Participant Flow|Sequence 6: Placebo, Levo 400µg and Levo 200µg|Participants received placebo, Levo 400µg and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
11161767|NCT01949051|OG000|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
11161768|NCT01949051|OG001|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
11161769|NCT01949051|OG002|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
11161770|NCT01949051|EG000|Reported Event|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
11161771|NCT01949051|EG001|Reported Event|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
11161772|NCT01949051|EG002|Reported Event|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
11161773|NCT01949090|BG000|Baseline|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161774|NCT01949090|BG001|Baseline|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161775|NCT01949090|BG002|Baseline|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161776|NCT01949090|BG003|Baseline|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161777|NCT01949090|BG004|Baseline|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161778|NCT01949090|BG005|Baseline|Total|Total of all reporting groups
11161779|NCT01949090|FG000|Participant Flow|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161780|NCT01949090|FG001|Participant Flow|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161781|NCT01949090|FG002|Participant Flow|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161782|NCT01949090|FG003|Participant Flow|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161783|NCT01949090|FG004|Participant Flow|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161784|NCT01949090|OG000|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161785|NCT01949090|OG001|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161786|NCT01949090|OG002|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161787|NCT01949090|OG003|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161788|NCT01949090|OG004|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161789|NCT01949090|OG004|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161790|NCT01949090|EG000|Reported Event|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161791|NCT01949090|EG001|Reported Event|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161792|NCT01949090|EG002|Reported Event|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161793|NCT01949090|EG003|Reported Event|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161794|NCT01949090|EG004|Reported Event|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
11161795|NCT01949116|BG000|Baseline|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants will receive 5 mg of LDMTX once a week. For participants who are clinically stable at the Week 1 study visit, the dose will be increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose will be increased to 15 mg once a week through Week 24. In addition to LDMTX, all participants will also receive 1 mg of folic acid once a day from study entry through 4 weeks after LDMTX is discontinued, either at Week 24 or earlier, for any reason.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161796|NCT01949116|BG001|Baseline|Placebo|"From study entry through Week 1, participants will receive 5 mg of placebo once a week. For participants who are clinically stable at the Week 1 study visit, the dose will be increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose will be increased to 15 mg once a week through Week 24. In addition to placebo, all participants will also receive 1 mg of folic acid once a day from study entry through 4 weeks after placebo is discontinued, either at Week 24 or earlier, for any reason.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161797|NCT01949116|BG002|Baseline|Total|Total of all reporting groups
11161798|NCT01949116|FG000|Participant Flow|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation were re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161799|NCT01949116|FG001|Participant Flow|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation were re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161800|NCT01949116|OG000|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants will receive 5 mg of LDMTX once a week. For participants who are clinically stable at the Week 1 study visit, the dose will be increased to 10 mg once a week through Week 12. For participants who are clinically stable at the Week 12 study visit, the dose will be increased to 15 mg once a week through Week 24. In addition to LDMTX, all participants will also receive 1 mg of folic acid once a day from study entry through 4 weeks after LDMTX is discontinued, either at Week 24 or earlier, for any reason.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161801|NCT01949116|OG001|Outcome|Placebo|"From study entry through Week 1, participants will receive 5 mg of placebo once a week. For participants who are clinically stable at the Week 1 study visit, the dose will be increased to 10 mg once a week through Week 12. For participants who are clinically stable at the Week 12 study visit, the dose will be increased to 15 mg once a week through Week 24. In addition to placebo, all participants will also receive 1 mg of folic acid once a day from study entry through 4 weeks after placebo is discontinued, either at Week 24 or earlier, for any reason.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161802|NCT01949116|OG000|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11174323|NCT02020941|BG000|Baseline|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
11161803|NCT01949116|OG001|Outcome|Placebo|"From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161804|NCT01949116|OG000|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161805|NCT01949116|OG001|Outcome|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
11161806|NCT01949116|EG000|Reported Event|LDMTX|From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.
11161807|NCT01949116|EG001|Reported Event|Placebo|From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.
11161808|NCT01949142|BG000|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
11161809|NCT01949142|BG001|Baseline|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
11161810|NCT01949142|BG002|Baseline|Total|Total of all reporting groups
11161811|NCT01949142|FG000|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
11161812|NCT01949142|FG001|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
11161813|NCT01949142|OG000|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
11161814|NCT01949142|OG001|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
11161815|NCT01949142|OG001|Outcome|Sham|Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery.
11161816|NCT01949142|EG000|Reported Event|OTO-201 Single, Intratympanic Injection|OTO-201: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.
11161817|NCT01949142|EG001|Reported Event|Sham-Simulated Single, Intratympanic Injection|Sham: One sham injection into each ear during surgery.
11161818|NCT01949155|BG000|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
11161819|NCT01949155|BG001|Baseline|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
11161820|NCT01949155|BG002|Baseline|Total|Total of all reporting groups
11161821|NCT01949155|FG000|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
11161822|NCT01949155|FG001|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
11161823|NCT01949155|OG000|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
11161824|NCT01949155|OG001|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
11161825|NCT01949155|OG001|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery"
11161826|NCT01949155|EG000|Reported Event|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
11161827|NCT01949155|EG001|Reported Event|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
11161828|NCT01949337|BG000|Baseline|Arm A: (Enzalutamide)|Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
11161829|NCT01949337|BG001|Baseline|Arm B: (Enzalutamide, Abiraterone, Prednisone)|Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
11161830|NCT01949337|BG002|Baseline|Total|Total of all reporting groups
11161831|NCT01949337|FG000|Participant Flow|Arm A: (Enzalutamide)|Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
11161832|NCT01949337|FG001|Participant Flow|Arm B: (Enzalutamide, Abiraterone, Prednisone)|Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
11161833|NCT01949337|OG000|Outcome|Arm A: (Enzalutamide)|Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
11161834|NCT01949337|OG001|Outcome|Arm B: (Enzalutamide, Abiraterone, Prednisone)|Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
11161835|NCT01949337|EG000|Reported Event|Arm A: (Enzalutamide)|Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
11161836|NCT01949337|EG001|Reported Event|Arm B: (Enzalutamide, Abiraterone, Prednisone)|Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
11161837|NCT01949389|BG000|Baseline|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
11161838|NCT01949389|FG000|Participant Flow|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
11161839|NCT01949389|OG000|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
11161840|NCT01949389|EG000|Reported Event|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
11161841|NCT01949480|BG000|Baseline|Traditional Approach Paravertebral Nerve Block|"After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.~Thoracotomy~Video-Assisted Thoracoscopic Surgery (VATS)"
11161842|NCT01949480|BG001|Baseline|Ultrasound Assisted Paravertebral Nerve Block|"The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.~Thoracotomy~Video-Assisted Thoracoscopic Surgery (VATS)"
11161843|NCT01949480|BG002|Baseline|Total|Total of all reporting groups
11161844|NCT01949480|FG000|Participant Flow|Traditional Approach Paravertebral Nerve Block|"After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.~Thoracotomy~Video-Assisted Thoracoscopic Surgery (VATS)"
11349188|NCT04114058|EG001|Reported Event|Fascia Iliaca Blockade|"Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control~Fascia iliaca blockade: fascia iliaca compartment blockade"
11161845|NCT01949480|FG001|Participant Flow|Ultrasound Assisted Paravertebral Nerve Block|"The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.~Thoracotomy~Video-Assisted Thoracoscopic Surgery (VATS)"
11161846|NCT01949480|OG000|Outcome|Traditional Approach Paravertebral Nerve Block|"After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.~Thoracotomy~Video-Assisted Thoracoscopic Surgery (VATS)"
11161847|NCT01949480|OG001|Outcome|Ultrasound Assisted Paravertebral Nerve Block|"The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.~Thoracotomy~Video-Assisted Thoracoscopic Surgery (VATS)"
11161848|NCT01949480|EG000|Reported Event|Traditional Approach Paravertebral Nerve Block|"After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.~Thoracotomy~Video-Assisted Thoracoscopic Surgery (VATS)"
11161849|NCT01949480|EG001|Reported Event|Ultrasound Assisted Paravertebral Nerve Block|"The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.~Thoracotomy~Video-Assisted Thoracoscopic Surgery (VATS)"
11161850|NCT01949532|BG000|Baseline|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
11161851|NCT01949532|BG001|Baseline|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
11161852|NCT01949532|BG002|Baseline|Total|Total of all reporting groups
11161853|NCT01949532|FG000|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance [CrCl] ≥ 75 mL/min) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
11161854|NCT01949532|FG001|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (on hemodialysis) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
11161855|NCT01949532|OG000|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
11161856|NCT01949532|OG001|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
11161857|NCT01949532|EG000|Reported Event|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
11161858|NCT01949532|EG001|Reported Event|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
11161859|NCT01949545|BG000|Baseline|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161860|NCT01949545|BG001|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161861|NCT01949545|BG002|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161862|NCT01949545|BG003|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161863|NCT01949545|BG004|Baseline|Total|Total of all reporting groups
11161864|NCT01949545|FG000|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161865|NCT01949545|FG001|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161866|NCT01949545|FG002|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161867|NCT01949545|FG003|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161868|NCT01949545|OG000|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161869|NCT01949545|OG001|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161870|NCT01949545|OG002|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161871|NCT01949545|OG003|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11228208|NCT02388737|EG002|Reported Event|Lansoprazole 15 mg|Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
11161872|NCT01949545|EG000|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161873|NCT01949545|EG001|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161874|NCT01949545|EG002|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161875|NCT01949545|EG003|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
11161876|NCT01949662|BG000|Baseline|Intervention Group (Lorazepam & Haloperidol)|Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
11161877|NCT01949662|BG001|Baseline|Control Group (Placebo & Haloperidol)|Received single dose of Haloperidol (2mg IV, once)
11161878|NCT01949662|BG002|Baseline|Total|Total of all reporting groups
11161879|NCT01949662|FG000|Participant Flow|Intervention Group (Lorazepam & Haloperidol)|Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
11161880|NCT01949662|FG001|Participant Flow|Control Group (Placebo & Haloperidol)|Received single dose of Haloperidol (2mg IV, once)
11161881|NCT01949662|OG000|Outcome|Intervention Group (Lorazepam & Haloperidol)|Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
11161882|NCT01949662|OG001|Outcome|Control Group (Placebo & Haloperidol)|Received single dose of Haloperidol (2mg IV, once)
11161883|NCT01949662|EG000|Reported Event|Intervention Group (Lorazepam & Haloperidol)|Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
11161884|NCT01949662|EG001|Reported Event|Control Group (Placebo & Haloperidol)|Received single dose of Haloperidol (2mg IV, once)
11161885|NCT01949779|BG000|Baseline|TransForm OBC|TransForm Occlusion Balloon Catheter
11161886|NCT01949779|FG000|Participant Flow|TransForm OBC|TransForm Occlusion Balloon Catheter
11161887|NCT01949779|OG000|Outcome|TransForm™ OBC|TransForm™ Occlusion Balloon Catheter
11161888|NCT01949779|EG000|Reported Event|TransForm OBC|TransForm Occlusion Balloon Catheter
11161889|NCT01949844|BG000|Baseline|Suspected Coronary Artery Disease (CAD)|This pilot study involved a single arm/group of subjects with suspected CAD who were recruited to undergo an improved cardiac magnetic resonance imaging (MRI) protocol with vasodilator stress (Regadenoson) for detection of myocardial perfusion defects. All subjects were recruited based on the following inclusion criteria: (a) prior nuclear myocardial perfusion (PET/SPECT) scan with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, (b) clinically stable individuals with suspected coronary artery disease on the basis of invasive or noninvasive coronary angiography.
11161890|NCT01949844|FG000|Participant Flow|Suspected Coronary Artery Disease (CAD)|"This pilot study involved a single arm/group of subjects with suspected CAD who all underwent cardiac magnetic resonance imaging (MRI) based on the following inclusion criteria:~Prior nuclear myocardial perfusion (PET/SPECT) scan with a visual interpretation of definitely abnormal, or prior myocardial infarction; or,~Clinically stable individuals with suspected coronary artery disease on the basis of coronary angiography.~Study Protocol: MRI for detection of perfusion deficits using an improved technique with the administration of a vasodilator drug (Regadenoson) and gadolinium-based MRI contrast agent (with standard dose of 0.2 mmol/kg).~Vasodilator drug (Regadenoson) used in the study: Lexiscan® (FDA-issued IND# 119898) was used off-label as a vasodilator drug during the cardiac MRI scan as prescribed in the package insert (0.4 mg/5mL bolus followed by saline flush) supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes."
11161891|NCT01949844|OG000|Outcome|Suspected Coronary Artery Disease (CAD)|"This pilot study has a single arm/group of subjects with suspected CAD based on the following inclusion criteria:~Prior nuclear myocardial perfusion scan (PET/SPECT) with a visual interpretation of definitely abnormal, or prior myocardial infarction; or,~Clinically stable individuals with suspected coronary artery disease on the basis of coronary angiography.~The study protocol involved only a myocardial perfusion MRI procedure for detection of ischemia (perfusion deficits) using an improved protocol with the administration of a vasodilator drug (Regadenoson/Lexiscan®) and gadolinium-based MRI contrast agent (Optimark®; dose: 0.2 mmol/kg). Lexiscan® was used off-label as a vasodilator drug during the MRI scan (0.4 mg/5mL) supplied by the manufacturer, Astellas Pharma U.S."
11161892|NCT01949844|EG000|Reported Event|Suspected Coronary Artery Disease (CAD)|This pilot study involved a single arm/group of subjects with suspected CAD who were recruited to undergo an improved cardiac magnetic resonance imaging (MRI) protocol with vasodilator stress (Regadenoson) for detection of myocardial perfusion defects. All subjects were recruited based on the following inclusion criteria: (a) prior nuclear myocardial perfusion scan with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, (b) clinically stable individuals with suspected coronary artery disease on the basis of invasive or noninvasive coronary angiography.
11161893|NCT01949870|BG000|Baseline|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
11161894|NCT01949870|FG000|Participant Flow|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
11161895|NCT01949870|OG000|Outcome|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
11161896|NCT01949870|EG000|Reported Event|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
11161897|NCT01950013|BG000|Baseline|Passive Control|Hearing aid alone
11161898|NCT01950013|BG001|Baseline|Training|"Auditory Training Program. Hearing aid plus auditory training~Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids."
11161899|NCT01950013|BG002|Baseline|Active Control|"Sham comparator: Active control. Hearing aid plus audio-book use~Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training."
11161900|NCT01950013|BG003|Baseline|Total|Total of all reporting groups
11161901|NCT01950013|FG000|Participant Flow|Passive Control|Hearing aid alone
11161902|NCT01950013|FG001|Participant Flow|Training|"Auditory Training Program. Hearing aid plus auditory training~Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids."
11161903|NCT01950013|FG002|Participant Flow|Active Control|"Sham comparator: Active control. Hearing aid plus audio-book use~Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training."
11161904|NCT01950013|OG000|Outcome|Passive Control|Hearing aid alone
11161905|NCT01950013|OG001|Outcome|Training|"Auditory Training Program. Hearing aid plus auditory training~Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids."
11161906|NCT01950013|OG002|Outcome|Active Control|"Sham comparator: Active control. Hearing aid plus audio-book use~Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training."
11161907|NCT01950013|EG000|Reported Event|Passive Control|Hearing aid alone
11161908|NCT01950013|EG001|Reported Event|Training|"Auditory Training Program. Hearing aid plus auditory training~Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids."
11161909|NCT01950013|EG002|Reported Event|Active Control|"Sham comparator: Active control. Hearing aid plus audio-book use~Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training."
11161910|NCT01950039|BG000|Baseline|Betaine|"Betaine:~Participants were instructed to take betaine 3300 mg (10 ml) orally twice daily for 10 days, then 4950 mg (15 ml) orally twice daily through 12 weeks."
11161911|NCT01950039|BG001|Baseline|Placebo|Placebo: Participants were instructed to take identical amounts and appearance of placebo through 12 weeks.
11161912|NCT01950039|BG002|Baseline|Total|Total of all reporting groups
11161913|NCT01950039|FG000|Participant Flow|Betaine|"Betaine:~Participants were instructed to take betaine 3300 mg (10 ml) orally twice daily for 10 days, then 4950 mg (15 ml) orally twice daily through 12 weeks."
11161914|NCT01950039|FG001|Participant Flow|Placebo|Placebo: Participants were instructed to take identical amounts and appearance of placebo through 12 weeks.
11161915|NCT01950039|OG000|Outcome|Betaine|"Betaine:~Participants were instructed to take betaine 3300 mg (10 ml) orally twice daily for 10 days, then 4950 mg (15 ml) orally twice daily through 12 weeks."
11161916|NCT01950039|OG001|Outcome|Placebo|Placebo: Participants were instructed to take identical amounts and appearance of placebo through 12 weeks.
11161917|NCT01950039|EG000|Reported Event|Betaine|"Betaine:~Participants were instructed to take betaine 3300 mg (10 ml) orally twice daily for 10 days, then 4950 mg (15 ml) orally twice daily through 12 weeks."
11161918|NCT01950039|EG001|Reported Event|Placebo|Placebo: Participants were instructed to take identical amounts and appearance of placebo through 12 weeks.
11161919|NCT01950078|BG000|Baseline|Surgical Patients|grouped by receiving surgery
11161920|NCT01950078|BG001|Baseline|Healthy Volunteers Group|grouped by healthy college students
11161921|NCT01950078|BG002|Baseline|Total|Total of all reporting groups
11161922|NCT01950078|FG000|Participant Flow|Surgical Patients|grouped by receiving surgery
11161923|NCT01950078|FG001|Participant Flow|Healthy Volunteers Group|grouped by healthy college students
11161924|NCT01950078|OG000|Outcome|Surgical Patients|grouped by receiving surgery
11161925|NCT01950078|OG001|Outcome|Healthy Volunteers Group|grouped by healthy college students
11161926|NCT01950078|EG000|Reported Event|Surgical Patients|grouped by receiving surgery
11161927|NCT01950078|EG001|Reported Event|Healthy Volunteers Group|grouped by healthy college students
11161928|NCT01950169|BG000|Baseline|Group B, Bisphosphonate|Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.
11161929|NCT01950169|BG001|Baseline|Group BN/N, Bisphosphonates Along With Nutritional Supplementation|Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein.
11161930|NCT01950169|BG002|Baseline|C, Control|Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months.
11161931|NCT01950169|BG003|Baseline|Total|Total of all reporting groups
11161932|NCT01950169|FG000|Participant Flow|Group B, Bisphosphonates|Patients allocated to intervention B received 35 mg risedronate once weekly for 12 months and 1,000 mg calcium and 800 IU vitamin D3 daily.
11161933|NCT01950169|FG001|Participant Flow|Group BN/N, Bisphosphonates Along With Nutritional Supplementation|Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein.
11161934|NCT01950169|FG002|Participant Flow|Group C, Control|Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months.
11161935|NCT01950169|OG000|Outcome|B, Bisphosphonate|Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.
11161936|NCT01950169|OG001|Outcome|BN/N, Bisphosphonate Along With Nutritional Supplementation|Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).
11161937|NCT01950169|OG002|Outcome|C, Control|The patients were randomized to receive calcium and vitamin D3 alone and served as controls.
11161938|NCT01950169|OG000|Outcome|B, Bisphosphonate|Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily. Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline, 6.and 12 months.
11161939|NCT01950169|EG000|Reported Event|B, Bisphosphonate|Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.
11161940|NCT01950169|EG001|Reported Event|BN/N, Bisphosphonate Along With Nutritional Supplementation|Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).
11161941|NCT01950169|EG002|Reported Event|C, Control|The patients were randomized to receive calcium and vitamin D3 alone and served as controls.
11161942|NCT01950260|BG000|Baseline|Levothyroxine|"In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.~Levothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks)."
11161943|NCT01950260|BG001|Baseline|Placebo|"In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.~Placebo: Placebo to start at 4 weeks after RAI"
11161944|NCT01950260|BG002|Baseline|Total|Total of all reporting groups
11161945|NCT01950260|FG000|Participant Flow|Levothyroxine|"In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.~Levothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks)."
11161946|NCT01950260|FG001|Participant Flow|Placebo|"In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.~Placebo: Placebo to start at 4 weeks after RAI"
11161947|NCT01950260|OG000|Outcome|Levothyroxine|"In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.~Levothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks)."
11161948|NCT01950260|OG001|Outcome|Placebo|"In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.~Placebo: Placebo to start at 4 weeks after RAI"
11161949|NCT01950260|EG000|Reported Event|Levothyroxine|"In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.~Levothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks)."
11161950|NCT01950260|EG001|Reported Event|Placebo|"In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.~Placebo: Placebo to start at 4 weeks after RAI"
11161951|NCT01950273|BG000|Baseline|BI 695500|The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
11161952|NCT01950273|BG001|Baseline|Rituximab (MabThera®)|The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
11161953|NCT01950273|BG002|Baseline|Total|Total of all reporting groups
11161954|NCT01950273|FG000|Participant Flow|BI 695500|The subjects received BI 695500 (Test)/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
11161955|NCT01950273|FG001|Participant Flow|Rituximab (MabThera®)|The subjects received Rituximab (MabThera® (Reference))/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
11161956|NCT01950273|OG000|Outcome|BI 695500|The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
11161957|NCT01950273|OG001|Outcome|Rituximab (MabThera®)|The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
11161958|NCT01950273|EG000|Reported Event|BI 695500|The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
11161959|NCT01950273|EG001|Reported Event|Rituximab (MabThera®)|The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
11161960|NCT01950299|BG000|Baseline|Anakinra (Standard Dose)|Anakinra 100 mg daily for 14 days
11161961|NCT01950299|BG001|Baseline|Anakinra (High Dose)|Anakinra 100 mg twice daily for 14 days
11161962|NCT01950299|BG002|Baseline|Placebo|Placebo for 14 days
11161963|NCT01950299|BG003|Baseline|Total|Total of all reporting groups
11161964|NCT01950299|FG000|Participant Flow|Anakinra (Standard Dose)|Anakinra 100 mg daily for 14 days
11161965|NCT01950299|FG001|Participant Flow|Anakinra (High Dose)|Anakinra 100 mg twice daily for 14 days
11161966|NCT01950299|FG002|Participant Flow|Placebo|Placebo for 14 days
11161967|NCT01950299|OG000|Outcome|Anakinra (Standard Dose)|Anakinra 100 mg daily for 14 days
11161968|NCT01950299|OG001|Outcome|Anakinra (High Dose)|Anakinra 100 mg twice daily for 14 days
11161969|NCT01950299|OG002|Outcome|Placebo|Placebo for 14 days
11161970|NCT01950299|EG000|Reported Event|Anakinra (Standard Dose)|Anakinra 100 mg daily for 14 days
11161971|NCT01950299|EG001|Reported Event|Anakinra (High Dose)|Anakinra 100 mg twice daily for 14 days
11161972|NCT01950299|EG002|Reported Event|Placebo|Placebo for 14 days
11161973|NCT01950364|BG000|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
11161974|NCT01950364|BG001|Baseline|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
11161975|NCT01950364|BG002|Baseline|Total|Total of all reporting groups
11161976|NCT01950364|FG000|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
11161977|NCT01950364|FG001|Participant Flow|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
11161978|NCT01950364|OG000|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
11161979|NCT01950364|OG001|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
11161980|NCT01950364|EG000|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
11161981|NCT01950364|EG001|Reported Event|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
11161982|NCT01950663|BG000|Baseline|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
11161983|NCT01950663|FG000|Participant Flow|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
11161984|NCT01950663|OG000|Outcome|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
11161985|NCT01950663|EG000|Reported Event|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
11161986|NCT01950741|BG000|Baseline|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
11161987|NCT01950741|FG000|Participant Flow|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
11228209|NCT02388763|BG000|Baseline|Overall|Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
11161988|NCT01950741|OG000|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
11161989|NCT01950741|EG000|Reported Event|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.~Among 48 patients enrolled, one patient withdrew the consent before undergoing the first injection. Therefore the adverse event was assessed in 47 patients."
11173996|NCT02019108|BG000|Baseline|Gait Modification Group|"Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.~Progressive walking program with toe-out gait modification: Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group."
11173997|NCT02019108|BG001|Baseline|Walking Only Group|"Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.~Progressive walking program: At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity."
11173998|NCT02019108|BG002|Baseline|Total|Total of all reporting groups
11173999|NCT02019108|FG000|Participant Flow|Gait Modification Group|"Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.~Progressive walking program with toe-out gait modification: Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group."
11174000|NCT02019108|FG001|Participant Flow|Walking Only Group|"Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.~Progressive walking program: At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity."
11174001|NCT02019108|OG000|Outcome|Gait Modification Group|"Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.~Progressive walking program with toe-out gait modification: Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group."
11174002|NCT02019108|OG001|Outcome|Walking Only Group|"Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.~Progressive walking program: At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity."
11174003|NCT02019108|EG000|Reported Event|Gait Modification Group|"Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.~Progressive walking program with toe-out gait modification: Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group."
11161990|NCT01950780|BG000|Baseline|Ruxolitinib|"A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.~Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects."
11161991|NCT01950780|FG000|Participant Flow|Ruxolitinib|"A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.~Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects."
11161992|NCT01950780|OG000|Outcome|Ruxolitinib|"A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.~Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects."
11161993|NCT01950780|OG000|Outcome|Ruxolitinib|"A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.~Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.~No serious adverse effects noted"
11161994|NCT01950780|EG000|Reported Event|Ruxolitinib|"A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.~Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects."
11161995|NCT01950819|BG000|Baseline|EVR+rCNI|Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
11161996|NCT01950819|BG001|Baseline|MPA+sCNI|Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
11161997|NCT01950819|BG002|Baseline|Total|Total of all reporting groups
11161998|NCT01950819|FG000|Participant Flow|EVR+rCNI|Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
11161999|NCT01950819|FG001|Participant Flow|MPA+sCNI|Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
11162000|NCT01950819|OG000|Outcome|EVR+rCNI|Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
11162001|NCT01950819|OG001|Outcome|MPA+sCNI|Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
11162002|NCT01950819|EG000|Reported Event|Everolimus Plus@Reduced CNI|Everolimus plus@reduced CNI
11162003|NCT01950819|EG001|Reported Event|MPA Plus Standard@CNI|MPA plus standard@CNI
11162004|NCT01951066|BG000|Baseline|All Participants|
11162005|NCT01951066|FG000|Participant Flow|Group 1 (Dexamethasone Implant/Anti-VEGF)|"Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.~Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant~Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
11162006|NCT01951066|FG001|Participant Flow|Group 2 (Anti-VEGF/Dexamethasone Implant)|"Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.~Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant~Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
11162007|NCT01951066|OG000|Outcome|Dexamethasone Implant|Patients received an injection of an dexamethasone implant
11162008|NCT01951066|OG001|Outcome|Anti-VEGF Agent|Patients received PRN injections of an Anti-VEGF agent
11162009|NCT01951066|EG000|Reported Event|All Participants|
11162010|NCT01951092|BG000|Baseline|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
11162011|NCT01951092|FG000|Participant Flow|Single Arm Intervention Study|"All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.~Text messaging"
11162012|NCT01951092|OG000|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
11162013|NCT01951092|EG000|Reported Event|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
11162014|NCT01951105|BG000|Baseline|Observation|Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
11162015|NCT01951105|BG001|Baseline|Carbidopa/Levodopa & Naproxen|"Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).~Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period."
11162016|NCT01951105|BG002|Baseline|Placebo & Naproxen|Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
11162017|NCT01951105|BG003|Baseline|Total|Total of all reporting groups
11162018|NCT01951105|FG000|Participant Flow|Observation|Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
11162019|NCT01951105|FG001|Participant Flow|Carbidopa/Levodopa & Naproxen|"Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).~Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period."
11162020|NCT01951105|FG002|Participant Flow|Placebo & Naproxen|Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
11162021|NCT01951105|OG000|Outcome|Observation|Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
11162022|NCT01951105|OG001|Outcome|Carbidopa/Levodopa & Naproxen|"Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).~Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period."
11162023|NCT01951105|OG002|Outcome|Placebo & Naproxen|Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
11162024|NCT01951105|OG000|Outcome|Carbidopa/Levodopa & Naproxen (Males)|"Male individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).~Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period."
11162025|NCT01951105|OG001|Outcome|Carbidopa/Levodopa & Naproxen (Females)|"Female individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).~Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period."
11162026|NCT01951105|OG002|Outcome|Placebo & Naproxen (Males)|Male individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
11162027|NCT01951105|OG003|Outcome|Placebo & Naproxen (Females)|Female individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
11162028|NCT01951105|OG004|Outcome|Observation (Males)|Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
11162029|NCT01951105|OG005|Outcome|Observation (Females)|Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
11162030|NCT01951105|EG000|Reported Event|Observation|Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
11162031|NCT01951105|EG001|Reported Event|Carbidopa/Levodopa & Naproxen|"Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).~Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period."
11162032|NCT01951105|EG002|Reported Event|Placebo & Naproxen|Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
11162033|NCT01951118|BG000|Baseline|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item UPSIT immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease. For patients who do not tolerate donepezil or have a history of intolerance to donepezil or cannot take donepezil for other reasons, treatment with other cholinesterase inhibitors (galantamine or rivastigmine) is permitted at any stage of the protocol. Data will be analyzed in two ways: for donepezil alone, and for any cholinesterase inhibitor (donepezil or rivastigmine or galantamine)."
11162034|NCT01951118|FG000|Participant Flow|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item UPSIT immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease. For patients who do not tolerate donepezil or have a history of intolerance to donepezil or cannot take donepezil for other reasons, treatment with other cholinesterase inhibitors (galantamine or rivastigmine) is permitted at any stage of the protocol. Data will be analyzed in two ways: for donepezil alone, and for any cholinesterase inhibitor (donepezil or rivastigmine or galantamine)."
11162035|NCT01951118|OG000|Outcome|MCI Sample|100 patients with MCI were analyzed for this sample.
11162036|NCT01951118|OG001|Outcome|AD Sample|21 patients with AD were analyzed for this sample.
11162037|NCT01951118|OG000|Outcome|MCI Sample|100 MCI participants were analyzed for this sample.
11162038|NCT01951118|OG001|Outcome|AD Sample|21 AD participants were analyzed for this sample.
11162039|NCT01951118|OG000|Outcome|MCI Sample|100 MCI participants were included in this sample.
11162040|NCT01951118|OG001|Outcome|AD Sample|21 AD participants were included in this sample.
11162041|NCT01951118|EG000|Reported Event|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item UPSIT immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease. For patients who do not tolerate donepezil or have a history of intolerance to donepezil or cannot take donepezil for other reasons, treatment with other cholinesterase inhibitors (galantamine or rivastigmine) is permitted at any stage of the protocol. Data will be analyzed in two ways: for donepezil alone, and for any cholinesterase inhibitor (donepezil or rivastigmine or galantamine)."
11162042|NCT01951157|BG000|Baseline|A - Docetaxel|"75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks~Docetaxel: Powder for solution for infusion"
11162043|NCT01951157|BG001|Baseline|B - Lurbinectedin (PM01183)|"In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles~Lurbinectedin (PM01183): Powder for concentrate for solution for infusion"
11162044|NCT01951157|BG002|Baseline|C - Gemcitabine + Lurbinectedin (PM01183)|"Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)~Gemcitabine: Powder for solution for infusion~Lurbinectedin (PM01183): Powder for concentrate for solution for infusion"
11162045|NCT01951157|BG003|Baseline|Total|Total of all reporting groups
11162046|NCT01951157|FG000|Participant Flow|A - Docetaxel|"75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks~Docetaxel: Powder for solution for infusion"
11162047|NCT01951157|FG001|Participant Flow|B - Lurbinectedin (PM01183)|"In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles~Lurbinectedin (PM01183): Powder for concentrate for solution for infusion"
11162048|NCT01951157|FG002|Participant Flow|C - Gemcitabine + Lurbinectedin (PM01183)|"Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)~Gemcitabine: Powder for solution for infusion~Lurbinectedin (PM01183): Powder for concentrate for solution for infusion"
11162049|NCT01951157|OG000|Outcome|A - Docetaxel|"75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks~Docetaxel: Powder for solution for infusion"
11162050|NCT01951157|OG001|Outcome|B - Lurbinectedin (PM01183)|"In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles~Lurbinectedin (PM01183): Powder for concentrate for solution for infusion"
11162051|NCT01951157|OG002|Outcome|C - Gemcitabine + Lurbinectedin (PM01183)|"Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)~Gemcitabine: Powder for solution for infusion~Lurbinectedin (PM01183): Powder for concentrate for solution for infusion"
11162052|NCT01951157|OG001|Outcome|B - Lurbinectedin (PM01183)|In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
11162053|NCT01951157|EG000|Reported Event|A - Docetaxel|"75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks~Docetaxel: Powder for solution for infusion"
11162054|NCT01951157|EG001|Reported Event|B - Lurbinectedin (PM01183)|"In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amedment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles~Lurbinectedin (PM01183): Powder for concentrate for solution for infusion"
11162055|NCT01951157|EG002|Reported Event|C - Gemcitabine + Lurbinectedin (PM01183)|"Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amedment 3)~Gemcitabine: Powder for solution for infusion~Lurbinectedin (PM01183): Powder for concentrate for solution for infusion"
11162056|NCT01951170|BG000|Baseline|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
11162057|NCT01951170|FG000|Participant Flow|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 milligrams (mg) was administered subcutaneously once weekly for 24 weeks"
11162058|NCT01951170|OG000|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
11162059|NCT01951170|EG000|Reported Event|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: Tocilizumab was administered 162 mg subcutaneously once weekly for 24 weeks"
11162060|NCT01951261|BG000|Baseline|Telemonitoring and Telephone Control|"Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.~Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist."
11162061|NCT01951261|BG001|Baseline|Home Care|Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
11162062|NCT01951261|BG002|Baseline|Total|Total of all reporting groups
11162063|NCT01951261|FG000|Participant Flow|Telemonitoring and Telephone Control|"Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.~Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist."
11162064|NCT01951261|FG001|Participant Flow|Home Care|Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
11162065|NCT01951261|OG000|Outcome|Telemonitoring and Telephone Control|"Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.~Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist."
11162066|NCT01951261|OG001|Outcome|Home Care|Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
11162067|NCT01951261|EG000|Reported Event|Telemonitoring and Telephone Control|"Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.~Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist."
11162068|NCT01951261|EG001|Reported Event|Home Care|Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
11162069|NCT01951326|BG000|Baseline|RHB-104|"5 RHB-104 capsules administered orally BID~RHB-104: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine"
11162070|NCT01951326|BG001|Baseline|Placebo|"5 placebo capsules administered orally BID~Placebo: 5 placebo capsules administered orally BID"
11162071|NCT01951326|BG002|Baseline|Total|Total of all reporting groups
11162072|NCT01951326|FG000|Participant Flow|RHB-104|"5 RHB-104 capsules administered orally BID~RHB-104: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine"
11162073|NCT01951326|FG001|Participant Flow|Placebo|"5 placebo capsules administered orally BID~Placebo: 5 placebo capsules administered orally BID"
11162074|NCT01951326|OG000|Outcome|RHB-104|"5 RHB-104 capsules administered orally BID~RHB-104: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine"
11162075|NCT01951326|OG001|Outcome|Placebo|"5 placebo capsules administered orally BID~Placebo: 5 placebo capsules administered orally BID"
11162076|NCT01951326|OG001|Outcome|Placebo|5 placebo capsules administered orally BID
11162077|NCT01951326|EG000|Reported Event|RHB-104|"5 RHB-104 capsules administered orally BID~RHB-104: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine"
11162078|NCT01951326|EG001|Reported Event|Placebo|"5 placebo capsules administered orally BID~Placebo: 5 placebo capsules administered orally BID"
11162079|NCT01951339|BG000|Baseline|Sitagliptin Plus Placebo|"100 mg sitagliptin plus 2 mg placebo once daily for three months~Sitagliptin: 100 mg sitagliptin~Placebo: 2 mg placebo once daily"
11162080|NCT01951339|BG001|Baseline|Glimepiride Plus Placebo|"2 mg glimepiride plus 100 mg placebo once daily for three months~Glimepiride: Active Comparator~2mg glimepiride~Placebo: 100 mg placebo once daily for three months"
11162081|NCT01951339|BG002|Baseline|Total|Total of all reporting groups
11162082|NCT01951339|FG000|Participant Flow|Sitagliptin Plus Placebo|"100 mg sitagliptin plus 2 mg placebo once daily for three months~Sitagliptin: 100 mg sitagliptin~Placebo: 2 mg placebo once daily"
11162083|NCT01951339|FG001|Participant Flow|Glimepiride Plus Placebo|"2 mg glimepiride plus 100 mg placebo once daily for three months~Glimepiride: Active Comparator~2mg glimepiride~Placebo: 100 mg placebo once daily for three months"
11162084|NCT01951339|OG000|Outcome|Sitagliptin Plus Placebo|"100 mg sitagliptin plus 2 mg placebo once daily for three months~Sitagliptin: 100 mg sitagliptin~Placebo: 2 mg placebo once daily"
11162085|NCT01951339|OG001|Outcome|Glimepiride Plus Placebo|"2 mg glimepiride plus 100 mg placebo once daily for three months~Glimepiride: Active Comparator~2mg glimepiride~Placebo: 100 mg placebo once daily for three months"
11162086|NCT01951339|EG000|Reported Event|Sitagliptin Plus Placebo|"100 mg sitagliptin plus 2 mg placebo once daily for three months~Sitagliptin: 100 mg sitagliptin~Placebo: 2 mg placebo once daily"
11162087|NCT01951339|EG001|Reported Event|Glimepiride Plus Placebo|"2 mg glimepiride plus 100 mg placebo once daily for three months~Glimepiride: Active Comparator~2mg glimepiride~Placebo: 100 mg placebo once daily for three months"
11162088|NCT01951352|BG000|Baseline|Soap Recipient|"The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study.~Soap"
11162089|NCT01951352|FG000|Participant Flow|Soap Recipient|"The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study.~Soap"
11162090|NCT01951352|OG000|Outcome|Soap Recipient|"The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study.~Soap"
11162091|NCT01951352|EG000|Reported Event|Soap Recipient|"The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study.~Soap"
11162092|NCT01951391|BG000|Baseline|Control Soap vs Benzalkonium Chloride Soap|Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with benzalkonium chloride soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The benzalkonium chloride forearm will be swabbed at baseline and 6 hours.
11162093|NCT01951391|BG001|Baseline|Control Soap vs Triclocarban Soap|Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with triclocarban soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The triclocarban forearm will be swabbed at baseline and 6 hours.
11162094|NCT01951391|BG002|Baseline|Total|Total of all reporting groups
11162095|NCT01951391|FG000|Participant Flow|Control Soap vs. Benzalkonium Chloride Soap|Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with benzalkonium chloride soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The benzalkonium chloride forearm will be swabbed at baseline and 6 hours.
11162096|NCT01951391|FG001|Participant Flow|Control Soap vs. Triclocarban Soap|Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with triclocarban soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The triclocarban forearm will be swabbed at baseline and 6 hours.
11162097|NCT01951391|OG000|Outcome|Control Hand Soap|Prior to washing, each subjects' forearms will be swabbed for bacteria. Each subject will then be washed with Softsoap aquarium series hand soap. They will then be swabbed at 10 minutes, 6 hours, and 24 hours to determine changes in bacteria levels.
11162098|NCT01951391|OG000|Outcome|Control Hand Soap|Prior to washing, each subjects' control soap forearm will be swabbed for bacteria. Each subject will then be washed with Softsoap aquarium series hand soap. They will then be swabbed at 6 hours to determine changes in staphylococcus epidermidis levels.
11162099|NCT01951391|OG001|Outcome|Benzalkonium Chloride Soap|Prior to washing, each subject's benzalkonium chloride forearm will be swabbed for bacteria. Each subject will then be washed with a soap containing benzalkonium chloride. They will then be swabbed at 6 hours to determine changes in staphylococcus epidermidis levels.
11162100|NCT01951391|OG002|Outcome|Triclocarban Soap|Prior to washing, each subject's triclocarban forearm will be swabbed for bacteria. Each subject will then be washed with a soap containing triclocarban. They will then be swabbed at 6 hours to determine changes in staphylococcus epidermidis levels.
11162101|NCT01951391|EG000|Reported Event|Control Soap vs. Benzalkonium Chloride Soap|Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with benzalkonium chloride soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The benzalkonium chloride forearm will be swabbed at baseline and 6 hours.
11162102|NCT01951391|EG001|Reported Event|Control Soap vs. Triclocarban Soap|Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with triclocarban soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The triclocarban forearm will be swabbed at baseline and 6 hours.
11162103|NCT01951417|BG000|Baseline|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
11162104|NCT01951417|FG000|Participant Flow|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
11162105|NCT01951417|OG000|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
11162106|NCT01951417|OG000|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
11162107|NCT01951417|OG001|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
11162108|NCT01951417|OG002|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
11162109|NCT01951417|OG003|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
11162110|NCT01951417|EG000|Reported Event|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
11162111|NCT01951573|BG000|Baseline|Overall|Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment.
11162112|NCT01951573|FG000|Participant Flow|Delefilcon A MF, Then AOAMF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
11162113|NCT01951573|FG001|Participant Flow|AOAMF, Then Delefilcon A MF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
11162114|NCT01951573|OG000|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
11162115|NCT01951573|OG001|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
11162116|NCT01951573|EG000|Reported Event|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
11162117|NCT01951573|EG001|Reported Event|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
11228210|NCT02388763|FG000|Participant Flow|Habitual, MyDay, 1DAVTE|Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
11162118|NCT01951586|BG000|Baseline|Placebo|Participants were randomized to receive placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
11162119|NCT01951586|BG001|Baseline|Denosumab|Participants were randomized to receive 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
11162120|NCT01951586|BG002|Baseline|Total|Total of all reporting groups
11162121|NCT01951586|FG000|Participant Flow|Placebo|Participants were randomized to receive placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
11162122|NCT01951586|FG001|Participant Flow|Denosumab|Participants were randomized to receive 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
11162123|NCT01951586|OG000|Outcome|Placebo|Participants were randomized to receive placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
11162124|NCT01951586|OG001|Outcome|Denosumab|Participants were randomized to receive 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
11162125|NCT01951586|OG000|Outcome|Denosumab|Participants were randomized to receive 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
11162126|NCT01951586|EG000|Reported Event|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
11162127|NCT01951586|EG001|Reported Event|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
11162128|NCT01951625|BG000|Baseline|Placebo|Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162129|NCT01951625|BG001|Baseline|BAY1021189 1.25 Milligram (mg)|Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162130|NCT01951625|BG002|Baseline|BAY1021189 2.5 mg|Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162131|NCT01951625|BG003|Baseline|BAY1021189 From 2.5 to 5 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28.
11162132|NCT01951625|BG004|Baseline|BAY1021189 From 2.5 to 10 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
11162133|NCT01951625|BG005|Baseline|Total|Total of all reporting groups
11162134|NCT01951625|FG000|Participant Flow|Placebo|Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162135|NCT01951625|FG001|Participant Flow|BAY1021189 1.25 Milligram (mg)|Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162136|NCT01951625|FG002|Participant Flow|BAY1021189 2.5 mg|Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162137|NCT01951625|FG003|Participant Flow|BAY1021189 From 2.5 to 5 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28.
11162138|NCT01951625|FG004|Participant Flow|BAY1021189 From 2.5 to 10 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
11162139|NCT01951625|OG000|Outcome|Placebo|Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162140|NCT01951625|OG001|Outcome|BAY1021189 1.25 Milligram (mg)|Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162141|NCT01951625|OG002|Outcome|BAY1021189 2.5 mg|Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162142|NCT01951625|OG003|Outcome|BAY1021189 From 2.5 to 5 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28.
11162143|NCT01951625|OG004|Outcome|BAY1021189 From 2.5 to 10 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
11162144|NCT01951625|OG005|Outcome|Pooled 2.5 mg up to 10 mg|The three highest dose arms (BAY1021189 2.5 mg, 2.5-5 mg, and 2.5-10 mg) were pooled.
11162145|NCT01951625|EG000|Reported Event|Placebo|Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162146|NCT01951625|EG001|Reported Event|BAY1021189 1.25 Milligram (mg)|Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162147|NCT01951625|EG002|Reported Event|BAY1021189 2.5 mg|Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162148|NCT01951625|EG003|Reported Event|BAY1021189 From 2.5 to 5 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28.
11162149|NCT01951625|EG004|Reported Event|BAY1021189 From 2.5 to 10 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
11162150|NCT01951638|BG000|Baseline|BAY1021189 1.25 mg|Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162151|NCT01951638|BG001|Baseline|Placebo|Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162152|NCT01951638|BG002|Baseline|BAY1021189 2.5 mg|Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162153|NCT01951638|BG003|Baseline|BAY1021189 2.5 mg to 5 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
11162154|NCT01951638|BG004|Baseline|BAY1021189 2.5 mg to 10 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
11162155|NCT01951638|BG005|Baseline|Total|Total of all reporting groups
11162156|NCT01951638|FG000|Participant Flow|Placebo|Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162157|NCT01951638|FG001|Participant Flow|BAY1021189 1.25 mg|Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162158|NCT01951638|FG002|Participant Flow|BAY1021189 2.5 mg|Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162159|NCT01951638|FG003|Participant Flow|BAY1021189 2.5 mg to 5 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
11162160|NCT01951638|FG004|Participant Flow|BAY1021189 2.5 mg to 10 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
11162161|NCT01951638|OG000|Outcome|Placebo|Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162162|NCT01951638|OG001|Outcome|BAY1021189 1.25 mg|Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162163|NCT01951638|OG002|Outcome|BAY1021189 2.5 mg|Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162164|NCT01951638|OG003|Outcome|BAY1021189 2.5 mg to 5 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg after 14 or 28 days. Sham titration included on Day 28.
11162165|NCT01951638|OG004|Outcome|BAY1021189 2.5 mg to 10 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
11162166|NCT01951638|EG000|Reported Event|Placebo|Subjects received placebo matched to vericiguat (BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162167|NCT01951638|EG001|Reported Event|BAY1021189 1.25 mg|Subjects received vericiguat (Verquvo, BAY1021189) 1.25 milligram (mg) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162168|NCT01951638|EG002|Reported Event|BAY1021189 2.5 mg|Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28.
11162169|NCT01951638|EG003|Reported Event|BAY1021189 From 2.5 to 5 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28.
11162170|NCT01951638|EG004|Reported Event|BAY1021189 From 2.5 to 10 mg|Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days.
11174004|NCT02019108|EG001|Reported Event|Walking Only Group|"Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.~Progressive walking program: At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity."
11162171|NCT01951651|BG000|Baseline|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11162172|NCT01951651|BG001|Baseline|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11162173|NCT01951651|BG002|Baseline|Total|Total of all reporting groups
11162174|NCT01951651|FG000|Participant Flow|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11162175|NCT01951651|FG001|Participant Flow|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11162176|NCT01951651|OG000|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11162177|NCT01951651|OG001|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11162178|NCT01951651|EG000|Reported Event|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11162179|NCT01951651|EG001|Reported Event|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11162180|NCT01951703|BG000|Baseline|Control/Test|Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study.
11162181|NCT01951703|BG001|Baseline|Test/Control|Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study.
11162182|NCT01951703|BG002|Baseline|Total|Total of all reporting groups
11162183|NCT01951703|FG000|Participant Flow|Control/Test|Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study.
11162184|NCT01951703|FG001|Participant Flow|Test/Control|Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study.
11162185|NCT01951703|OG000|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
11162186|NCT01951703|OG001|Outcome|Test, Senofilcon A|Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
11162187|NCT01951703|OG001|Outcome|Test, Senofilcon A|Subjects who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
11162188|NCT01951703|EG000|Reported Event|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
11162189|NCT01951703|EG001|Reported Event|Test, Senofilcon A|Subjects who received Test lens senofilcon A in either the first two weeks or the last two weeks of the study,
11162190|NCT01951768|BG000|Baseline|Garamycin Sponge (Gentamicin-Collagen Sponge)|"Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care~Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11162191|NCT01951768|BG001|Baseline|Systemic Antibiotic|"Systemic antibiotic therapy and standard ulcer care~Systemic Antibiotic: Antibiotics options per protocol:~Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h"
11162192|NCT01951768|BG002|Baseline|Total|Total of all reporting groups
11162193|NCT01951768|FG000|Participant Flow|Garamycin Sponge (Gentamicin-Collagen Sponge)|"Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care~Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11162194|NCT01951768|FG001|Participant Flow|Systemic Antibiotic|"Systemic antibiotic therapy and standard ulcer care~Systemic Antibiotic: Antibiotics options per protocol:~Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h"
11162195|NCT01951768|OG000|Outcome|Garamycin Sponge (Gentamicin-Collagen Sponge)|"Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care~Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11162196|NCT01951768|OG001|Outcome|Systemic Antibiotic|"Systemic antibiotic therapy and standard ulcer care~Systemic Antibiotic: Antibiotics options per protocol:~Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h"
11162197|NCT01951768|EG000|Reported Event|Garamycin Sponge (Gentamicin-Collagen Sponge)|"Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care~Garamycin Sponge (Gentamicin-Collagen sponge): Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11162198|NCT01951768|EG001|Reported Event|Systemic Antibiotic|"Systemic antibiotic therapy and standard ulcer care~Systemic Antibiotic: Antibiotics options per protocol:~Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h"
11162199|NCT01951820|BG000|Baseline|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
11162200|NCT01951820|BG001|Baseline|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
11162201|NCT01951820|BG002|Baseline|Total|Total of all reporting groups
11174005|NCT02019264|BG000|Baseline|Placebo|Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.
11174006|NCT02019264|BG001|Baseline|Lorcaserin 10 mg|Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
11162202|NCT01951820|FG000|Participant Flow|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
11162203|NCT01951820|FG001|Participant Flow|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
11162204|NCT01951820|OG000|Outcome|Benzocaine|"Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
11162205|NCT01951820|OG001|Outcome|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
11162206|NCT01951820|EG000|Reported Event|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
11162207|NCT01951820|EG001|Reported Event|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
11162208|NCT01951950|BG000|Baseline|Nicardipine|"Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication failure will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg."
11162209|NCT01951950|BG001|Baseline|Esmolol|"Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication failure will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg."
11162210|NCT01951950|BG002|Baseline|Total|Total of all reporting groups
11162211|NCT01951950|FG000|Participant Flow|Nicardipine|"Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication failure will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg."
11162212|NCT01951950|FG001|Participant Flow|Esmolol|"Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication failure will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg."
11162213|NCT01951950|OG000|Outcome|Nicardipine|"Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication failure will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg."
11162214|NCT01951950|OG001|Outcome|Esmolol|"Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication failure will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg."
11162215|NCT01951950|EG000|Reported Event|Nicardipine|"Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication failure will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg."
11162216|NCT01951950|EG001|Reported Event|Esmolol|"Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication failure will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg."
11174007|NCT02019264|BG002|Baseline|Total|Total of all reporting groups
11162217|NCT01951963|BG000|Baseline|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~The final sample included 40 subjects, 20 in the Ketamine group. Inclusion criteria was defined as, patients age 3-17 years old, medical or traumatic condition requiring intravenous opioid analgesics, ability to obtain consent from parents and assent from the patient. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
11162218|NCT01951963|BG001|Baseline|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
11162219|NCT01951963|BG002|Baseline|Total|Total of all reporting groups
11162220|NCT01951963|FG000|Participant Flow|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~The final sample included 40 subjects, 20 in the Ketamine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
11162221|NCT01951963|FG001|Participant Flow|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
11162222|NCT01951963|OG000|Outcome|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~Ketamine~prospective, double blind, randomized control trial. After informed consent, patients 3-17 years old requiring intravenous analgesics were randomized to receive either a single dose of 0.3mg/kg ketamine or 0.05mg/kg morphine in addition to standard opioid based analgesia. These weight-based doses of Ketamine and Morphine are the standard recommended doses from the Lexicomp Drug Reference Handbook, Pediatric and Neonatal Dosing (2011-2012)."
11162223|NCT01951963|OG001|Outcome|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~Morphine~prospective, double blind, randomized control trial. After informed consent, patients 3-17 years old requiring intravenous analgesics were randomized to receive either a single dose of 0.3mg/kg ketamine or 0.05mg/kg morphine in addition to standard opioid based analgesia. These weight-based doses of Ketamine and Morphine are the standard recommended doses from the Lexicomp Drug Reference Handbook, Pediatric and Neonatal Dosing (2011-2012)."
11162224|NCT01951963|OG000|Outcome|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~Ketamine"
11162225|NCT01951963|OG001|Outcome|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~Morphine"
11162226|NCT01951963|OG000|Outcome|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~The final sample included 40 subjects, 20 in the Ketamine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
11162227|NCT01951963|OG001|Outcome|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
11162228|NCT01951963|EG000|Reported Event|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~Ketamine"
11162229|NCT01951963|EG001|Reported Event|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~Morphine"
11162230|NCT01952015|BG000|Baseline|AIN457|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.~No up-titration group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.~Up-titration group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.~Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion."
11162231|NCT01952015|FG000|Participant Flow|AIN457|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.~No up-titration group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.~Up-titration group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.~Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion."
11162232|NCT01952015|OG000|Outcome|AIN457|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.~No up-titration group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.~Up-titration group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.~Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion."
11162233|NCT01952015|OG000|Outcome|Very Much Improved|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.~Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing."
11162234|NCT01952015|OG001|Outcome|Much Improved|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.~Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing."
11162235|NCT01952015|OG002|Outcome|Minimally Improved|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.~Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing."
11162236|NCT01952015|OG003|Outcome|No Change|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.~Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing."
11162237|NCT01952015|OG004|Outcome|Worse|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.~Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing."
11162238|NCT01952015|OG005|Outcome|Missing|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.~Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing."
11162239|NCT01952015|OG000|Outcome|None|All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
11162240|NCT01952015|OG001|Outcome|Mild|All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
11162241|NCT01952015|OG002|Outcome|Moderate|All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
11162242|NCT01952015|OG003|Outcome|Severe|All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
11162243|NCT01952015|OG004|Outcome|Missing|All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
11162244|NCT01952015|OG000|Outcome|AIN457|All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.
11162245|NCT01952015|EG000|Reported Event|AIN457|"All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.~No up-titration group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.~Up-titration group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.~Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion."
11162246|NCT01952041|BG000|Baseline|Device: Smartphone|Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.
11162247|NCT01952041|BG001|Baseline|Treatment as Usual|Treatment as usual included outpatient case management, linkage to services and medication monitoring.
11162248|NCT01952041|BG002|Baseline|Total|Total of all reporting groups
11162249|NCT01952041|FG000|Participant Flow|Device: Smartphone|Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.
11162250|NCT01952041|FG001|Participant Flow|Treatment as Usual|Treatment as usual included outpatient case management, linkage to services and medication monitoring.
11162251|NCT01952041|OG000|Outcome|Device: Smartphone|Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.
11162252|NCT01952041|OG001|Outcome|Treatment as Usual|Treatment as usual included outpatient case management, linkage to services and medication monitoring.
11162253|NCT01952041|EG000|Reported Event|Device: Smartphone|Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.
11162254|NCT01952041|EG001|Reported Event|Treatment as Usual|Treatment as usual included outpatient case management, linkage to services and medication monitoring.
11162255|NCT01952054|BG000|Baseline|Denosumab|Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
11162256|NCT01952054|FG000|Participant Flow|Denosumab|Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
11162257|NCT01952054|OG000|Outcome|Denosumab|Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
11174008|NCT02019264|FG000|Participant Flow|Placebo|Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.
11162258|NCT01952054|EG000|Reported Event|Denosumab|Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
11162259|NCT01952080|BG000|Baseline|Standard of Care|SOC- no teduglutide therapy
11162260|NCT01952080|BG001|Baseline|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
11162261|NCT01952080|BG002|Baseline|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
11162262|NCT01952080|BG003|Baseline|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
11162263|NCT01952080|BG004|Baseline|Total|Total of all reporting groups
11162264|NCT01952080|FG000|Participant Flow|Standard of Care|SOC- no teduglutide therapy
11162265|NCT01952080|FG001|Participant Flow|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
11162266|NCT01952080|FG002|Participant Flow|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
11162267|NCT01952080|FG003|Participant Flow|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
11162268|NCT01952080|OG000|Outcome|Standard of Care|SOC- no teduglutide therapy
11162269|NCT01952080|OG001|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
11162270|NCT01952080|OG002|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
11162271|NCT01952080|OG003|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
11162272|NCT01952080|EG000|Reported Event|Standard of Care|SOC- no teduglutide therapy
11162273|NCT01952080|EG001|Reported Event|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
11162274|NCT01952080|EG002|Reported Event|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
11162275|NCT01952080|EG003|Reported Event|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
11162276|NCT01952145|BG000|Baseline|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
11162277|NCT01952145|BG001|Baseline|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
11162278|NCT01952145|BG002|Baseline|Total|Total of all reporting groups
11162279|NCT01952145|FG000|Participant Flow|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
11162280|NCT01952145|FG001|Participant Flow|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
11162281|NCT01952145|OG000|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
11162282|NCT01952145|OG001|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
11174009|NCT02019264|FG001|Participant Flow|Lorcaserin 10 mg|Participants received lorcaserin HCL 10 milligram (mg), tablets, orally, twice daily for up to 52 months.
11174010|NCT02019264|OG000|Outcome|Placebo|Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.
11174011|NCT02019264|OG001|Outcome|Lorcaserin 10 mg|Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
11174012|NCT02019264|EG000|Reported Event|Placebo|Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.
11162283|NCT01952145|EG000|Reported Event|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
11162284|NCT01952145|EG001|Reported Event|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
11162285|NCT01952301|BG000|Baseline|Xenogeneic Collagen Matrix Versus Free Gingival Graft|free gingival graft versus a xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
11162286|NCT01952301|FG000|Participant Flow|XCM Versus FGG|xenogeneic collagen matrix versus free gingival graft
11162287|NCT01952301|OG000|Outcome|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
11162288|NCT01952301|OG001|Outcome|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap to generate keratinized tissue
11162289|NCT01952301|EG000|Reported Event|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
11162290|NCT01952301|EG001|Reported Event|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
11162291|NCT01952366|BG000|Baseline|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
11162292|NCT01952366|FG000|Participant Flow|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
11162293|NCT01952366|OG000|Outcome|Response in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.
11162294|NCT01952366|OG001|Outcome|Remission in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.
11162295|NCT01952366|OG000|Outcome|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
11162296|NCT01952366|OG000|Outcome|Patient With Dementia One Year After Inclusion to the Study|Number of patients admitted to specialist health care service of old age psychiatry who were diagnosed with dementia one year after inclusion to the study
11162297|NCT01952366|EG000|Reported Event|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
11162298|NCT01952418|BG000|Baseline|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
11162299|NCT01952418|BG001|Baseline|"Large Monitor (32)"|"Endoscopists in this arm will perform colonoscopy using the large size video monitor (32)."
11162300|NCT01952418|BG002|Baseline|Total|Total of all reporting groups
11162301|NCT01952418|FG000|Participant Flow|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
11162302|NCT01952418|FG001|Participant Flow|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
11162303|NCT01952418|OG000|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
11162304|NCT01952418|OG001|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
11162305|NCT01952418|EG000|Reported Event|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
11162306|NCT01952418|EG001|Reported Event|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
11162307|NCT01952444|BG000|Baseline|ETI-204|Participants received 16 mg/kg ETI-2041 by IV infusion over 90 minutes
11162308|NCT01952444|BG001|Baseline|ETI-204 + Ciprofloxacin|Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9
11162309|NCT01952444|BG002|Baseline|Total|Total of all reporting groups
11162310|NCT01952444|FG000|Participant Flow|ETI-204|"IV infusion of 16 mg/kg ETI-204~IV Ciprofloxacin: IV Infusion of 400 mg ciprofloxacin~Oral Ciprofloxacin: Oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and final dose on morning of Day 9"
11162311|NCT01952444|FG001|Participant Flow|ETI-204 and Ciprofloxacin|"IV infusion of 16 mg/kg ETI-204 followed by IV infusion of ciprofloxacin followed by oral ciprofloxacin~ETI-204: IV infusion of 16 mg/kg ETI-204"
11162312|NCT01952444|OG000|Outcome|ETI-204 + Ciprofloxacin|Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
11162313|NCT01952444|OG001|Outcome|ETI-204|Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
11162314|NCT01952444|OG000|Outcome|ETI-204 + Ciprofloxacin|Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9.
11162315|NCT01952444|OG001|Outcome|ETI-204 Alone|Participants received 16 mg/kg ETI-2041 by IV infusion over 90 minutes.
11162316|NCT01952444|OG001|Outcome|ETI-204|Participants received 16 mg/kg ETI-2041 by IV infusion over 90 minutes.
11162317|NCT01952444|OG000|Outcome|ETI-204 + Ciprofloxacin|Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9
11162318|NCT01952444|OG001|Outcome|ETI-204 Alone|Participants received 16 mg/kg ETI-2041 by IV infusion over 90 minutes
11162319|NCT01952444|EG000|Reported Event|ETI-204 + Ciprofloxacin|Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9
11162320|NCT01952444|EG001|Reported Event|ETI-204 Alone|Participants received 16 mg/kg ETI-2041 by IV infusion over 90 minutes
11162321|NCT01952470|BG000|Baseline|Dornase Alfa|"Once daily, 2.5ml inhaled dornase alfa.~Dornase Alfa: Once daily, 2.5ml inhaled dornase alpha (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able."
11162322|NCT01952470|BG001|Baseline|Isotonic Saline|"Once daily, 5ml inhaled 0.9% normal saline.~Isotonic Saline.: Once daily, 5ml inhaled 0.9% normal saline (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able."
11162323|NCT01952470|BG002|Baseline|Total|Total of all reporting groups
11162324|NCT01952470|FG000|Participant Flow|Dornase Alfa|"Once daily, 2.5ml inhaled dornase alfa.~Dornase Alfa: Once daily, 2.5ml inhaled dornase alfa (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able."
11162325|NCT01952470|FG001|Participant Flow|Isotonic Saline|"Once daily, 5ml inhaled 0.9% normal saline.~Isotonic Saline.: Once daily, 5ml inhaled 0.9% normal saline (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able."
11162326|NCT01952470|OG000|Outcome|Dornase Alfa|"Once daily, 2.5ml inhaled dornase alfa.~Dornase Alfa: Once daily, 2.5ml inhaled dornase alfa (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able."
11162327|NCT01952470|OG001|Outcome|Isotonic Saline|"Once daily, 5ml inhaled 0.9% normal saline.~Isotonic Saline.: Once daily, 5ml inhaled 0.9% normal saline (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able."
11162328|NCT01952470|EG000|Reported Event|Dornase Alfa|"Once daily, 2.5ml inhaled dornase alfa.~Dornase Alfa: Once daily, 2.5ml inhaled dornase alfa (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able."
11162329|NCT01952470|EG001|Reported Event|Isotonic Saline|"Once daily, 5ml inhaled 0.9% normal saline.~Isotonic Saline.: Once daily, 5ml inhaled 0.9% normal saline (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able."
11162330|NCT01952600|BG000|Baseline|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
11162331|NCT01952600|BG001|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
11162332|NCT01952600|BG002|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
11162333|NCT01952600|BG003|Baseline|Total|Total of all reporting groups
11162334|NCT01952600|FG000|Participant Flow|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
11162335|NCT01952600|FG001|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
11162336|NCT01952600|FG002|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
11162337|NCT01952600|OG000|Outcome|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
11162338|NCT01952600|OG001|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
11162339|NCT01952600|OG002|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
11162340|NCT01952600|EG000|Reported Event|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
11162341|NCT01952600|EG001|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
11162342|NCT01952600|EG002|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
11162343|NCT01952665|BG000|Baseline|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
11162344|NCT01952665|BG001|Baseline|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
11162345|NCT01952665|BG002|Baseline|Total|Total of all reporting groups
11162346|NCT01952665|FG000|Participant Flow|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
11162347|NCT01952665|FG001|Participant Flow|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
11162348|NCT01952665|OG000|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
11162349|NCT01952665|OG001|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
11162350|NCT01952665|OG001|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
11162351|NCT01952665|OG000|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
11162352|NCT01952665|OG002|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
11162353|NCT01952665|EG000|Reported Event|Comfilcon A|"Daily wear soft contact lens comfilcon A~lotrafilcon B: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
11162354|NCT01952665|EG001|Reported Event|Lotrafilcon B|"Daily wear soft contact lens lotrafilcon B~comfilcon A: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
11162355|NCT01952678|BG000|Baseline|DaTscan™- Non-Caucasian Participants|Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162356|NCT01952678|BG001|Baseline|DaTscan™- Caucasian Participants|Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162357|NCT01952678|BG002|Baseline|Total|Total of all reporting groups
11162358|NCT01952678|FG000|Participant Flow|DaTscan™- Non-Caucasian Participant|Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected Parkinson's disease (PD) or Essential tremor (ET) who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162359|NCT01952678|FG001|Participant Flow|DaTscan™- Caucasian Participants|Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162360|NCT01952678|OG000|Outcome|DaTscan™ - Non-Caucasian Participants|Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
11162361|NCT01952678|OG001|Outcome|DaTscan™ - Caucasian Participants|Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
11162362|NCT01952678|OG000|Outcome|DaTscan™ - Non-Caucasian Participants|Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging, were included in PP population and had a final clinical diagnosis of PD.
11162363|NCT01952678|OG001|Outcome|DaTscan™ - Caucasian Participants|Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging, were included in PP population and had a final clinical diagnosis of PD.
11162364|NCT01952678|OG000|Outcome|DaTscan™- Non-Caucasian Participants|Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of ET.
11162365|NCT01952678|OG001|Outcome|DaTscan™- Caucasian Participants|Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of ET.
11162366|NCT01952678|OG000|Outcome|DaTscan™ - Non-Caucasian Participants|Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging, were included in PP population and had a final clinical diagnosis of ET.
11162367|NCT01952678|OG001|Outcome|DaTscan™ - Caucasian Participants|Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging, were included in PP population and had a final clinical diagnosis of ET.
11162368|NCT01952678|OG000|Outcome|DaTscan™- Non-Caucasian Participants|Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162369|NCT01952678|OG001|Outcome|DaTscan™- Caucasian Participants|Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162370|NCT01952678|OG000|Outcome|DaTscan™- Non-Caucasian Participants|Non-Caucasian participants previously administered DaTscan™, included in PP population with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162371|NCT01952678|OG001|Outcome|DaTscan™- Caucasian Participants|Caucasian participants previously administered DaTscan™, included in PP population with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162372|NCT01952678|EG000|Reported Event|DaTscan™- Non-Caucasian Participants|Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162373|NCT01952678|EG001|Reported Event|DaTscan™ - Caucasian Participants|Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
11162374|NCT01952691|BG000|Baseline|Kinesiotaping|"all patients were implemented a kinesiotaping to align the hallux to correct position~kinesiotaping: correction method was used to align hallux."
11162375|NCT01952691|FG000|Participant Flow|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
11162376|NCT01952691|OG000|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
11162377|NCT01952691|EG000|Reported Event|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
11162378|NCT01952834|BG000|Baseline|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
11162379|NCT01952834|FG000|Participant Flow|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
11162380|NCT01952834|OG000|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
11162381|NCT01952834|OG000|Outcome|Probiotic Supplementation|The measurement of IL-2 represents the change in IL-12 +/- standard deviation of the change following 6 weeks of probiotic supplementation.
11162382|NCT01952834|EG000|Reported Event|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
11162383|NCT01953003|BG000|Baseline|Arm A : iv Vinflunine Plus Capecitabine|"Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.~vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²~Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²"
11162384|NCT01953003|BG001|Baseline|Arm B : Capecitabine|"1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest~Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²"
11162385|NCT01953003|BG002|Baseline|Total|Total of all reporting groups
11162386|NCT01953003|FG000|Participant Flow|Arm A : iv Vinflunine Plus Capecitabine|"Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.~vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²~Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²"
11162387|NCT01953003|FG001|Participant Flow|Arm B : Capecitabine|"1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest~Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²"
11162388|NCT01953003|OG000|Outcome|Arm A : iv Vinflunine Plus Capecitabine|"Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.~vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²~Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²"
11162389|NCT01953003|OG001|Outcome|Arm B : Capecitabine|"1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest~Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²"
11162390|NCT01953003|EG000|Reported Event|Arm A : iv Vinflunine Plus Capecitabine|"Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.~vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²~Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²"
11162391|NCT01953003|EG001|Reported Event|Arm B : Capecitabine|"1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest~Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²"
11162392|NCT01953081|BG000|Baseline|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
11162393|NCT01953081|BG001|Baseline|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
11162394|NCT01953081|BG002|Baseline|Total|Total of all reporting groups
11162395|NCT01953081|FG000|Participant Flow|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
11162396|NCT01953081|FG001|Participant Flow|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
11162397|NCT01953081|OG000|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
11162398|NCT01953081|OG001|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
11162399|NCT01953081|EG000|Reported Event|TD-8954|"TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours~TD-8954"
11162400|NCT01953081|EG001|Reported Event|Metoclopramide|"Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline~Metoclopramide"
11162401|NCT01953211|BG000|Baseline|Healthy Reproductive Age Women|
11162402|NCT01953211|FG000|Participant Flow|Healthy Reproductive Age Women|"These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months~combined oral contraceptives"
11162403|NCT01953211|OG000|Outcome|20 mcg EE|These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
11162404|NCT01953211|OG001|Outcome|30 mcg EE|These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
11162405|NCT01953211|OG002|Outcome|35 mcg EE|These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
11162406|NCT01953211|EG000|Reported Event|Healthy Reproductive Age Women|"These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months~combined oral contraceptives"
11162407|NCT01953224|BG000|Baseline|Game-based Intervention|"This arm will receive the game intervention, which will include provision of a mobile smartphone device, cellular data service, the game application loaded onto the device, credit to load approximately 40-50 songs onto the device, headphones, and an armband for wearing the device. Participants will also receive weekly counseling calls.~Game-based intervention: Investigators will provide participants with a smartphone and required accessories (gift card for downloading the game application and music, headphones, armband). The game, Zombies, Run! encourages walking/jogging by playing music interspersed with a continuous narrative. Periodic zombie chases encourage brief interval training. Participants will set goals to increase their activity and receive weekly brief counseling phone calls to provide feedback.~Smartphone"
11162408|NCT01953224|BG001|Baseline|Wait List Control|This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
11162409|NCT01953224|BG002|Baseline|Total|Total of all reporting groups
11162410|NCT01953224|FG000|Participant Flow|Game-based Intervention|"This arm will receive the game intervention, which will include provision of a mobile smartphone device, cellular data service, the game application loaded onto the device, credit to load approximately 40-50 songs onto the device, headphones, and an armband for wearing the device. Participants will also receive weekly counseling calls.~Game-based intervention: Investigators will provide participants with a smartphone and required accessories (gift card for downloading the game application and music, headphones, armband). The game, Zombies, Run! encourages walking/jogging by playing music interspersed with a continuous narrative. Periodic zombie chases encourage brief interval training. Participants will set goals to increase their activity and receive weekly brief counseling phone calls to provide feedback.~Smartphone"
11162411|NCT01953224|FG001|Participant Flow|Wait List Control|This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
11162412|NCT01953224|OG000|Outcome|Game-based Intervention|"This arm will receive the game intervention, which will include provision of a mobile smartphone device, cellular data service, the game application loaded onto the device, credit to load approximately 40-50 songs onto the device, headphones, and an armband for wearing the device. Participants will also receive weekly counseling calls.~Game-based intervention: Investigators will provide participants with a smartphone and required accessories (gift card for downloading the game application and music, headphones, armband). The game, Zombies, Run! encourages walking/jogging by playing music interspersed with a continuous narrative. Periodic zombie chases encourage brief interval training. Participants will set goals to increase their activity and receive weekly brief counseling phone calls to provide feedback.~Smartphone"
11162413|NCT01953224|OG001|Outcome|Wait List Control|This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
11162414|NCT01953224|EG000|Reported Event|Game-based Intervention|"This arm will receive the game intervention, which will include provision of a mobile smartphone device, cellular data service, the game application loaded onto the device, credit to load approximately 40-50 songs onto the device, headphones, and an armband for wearing the device. Participants will also receive weekly counseling calls.~Game-based intervention: Investigators will provide participants with a smartphone and required accessories (gift card for downloading the game application and music, headphones, armband). The game, Zombies, Run! encourages walking/jogging by playing music interspersed with a continuous narrative. Periodic zombie chases encourage brief interval training. Participants will set goals to increase their activity and receive weekly brief counseling phone calls to provide feedback.~Smartphone"
11162415|NCT01953224|EG001|Reported Event|Wait List Control|This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.
11162416|NCT01953237|BG000|Baseline|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
11174013|NCT02019264|EG001|Reported Event|Lorcaserin 10 mg|Participants received lorcaserin HCL 10 milligram (mg), tablets, orally, twice daily for up to 52 months.
11162417|NCT01953237|BG001|Baseline|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
11162418|NCT01953237|BG002|Baseline|Total|Total of all reporting groups
11162419|NCT01953237|FG000|Participant Flow|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
11162420|NCT01953237|FG001|Participant Flow|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
11162421|NCT01953237|OG000|Outcome|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
11162422|NCT01953237|OG001|Outcome|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
11162423|NCT01953237|EG000|Reported Event|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
11162424|NCT01953237|EG001|Reported Event|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
11162425|NCT01953328|BG000|Baseline|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11162426|NCT01953328|BG001|Baseline|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
11162427|NCT01953328|BG002|Baseline|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11162428|NCT01953328|BG003|Baseline|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
11162429|NCT01953328|BG004|Baseline|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
11162430|NCT01953328|BG005|Baseline|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
11162431|NCT01953328|BG006|Baseline|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11162432|NCT01953328|BG007|Baseline|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
11162433|NCT01953328|BG008|Baseline|Total|Total of all reporting groups
11162434|NCT01953328|FG000|Participant Flow|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11162435|NCT01953328|FG001|Participant Flow|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
11162436|NCT01953328|FG002|Participant Flow|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11162437|NCT01953328|FG003|Participant Flow|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
11162438|NCT01953328|FG004|Participant Flow|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
11162439|NCT01953328|FG005|Participant Flow|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
11162440|NCT01953328|FG006|Participant Flow|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11162441|NCT01953328|FG007|Participant Flow|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
11162442|NCT01953328|OG000|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11162443|NCT01953328|OG001|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
11162444|NCT01953328|OG002|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11162445|NCT01953328|OG003|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
11162446|NCT01953328|OG004|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
11162447|NCT01953328|OG005|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
11162448|NCT01953328|OG006|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11162449|NCT01953328|OG007|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
11162450|NCT01953328|EG000|Reported Event|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
11162451|NCT01953328|EG001|Reported Event|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
11162452|NCT01953328|EG002|Reported Event|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11162453|NCT01953328|EG003|Reported Event|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
11162454|NCT01953328|EG004|Reported Event|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
11162455|NCT01953328|EG005|Reported Event|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
11162456|NCT01953328|EG006|Reported Event|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
11162457|NCT01953328|EG007|Reported Event|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
11162458|NCT01953354|BG000|Baseline|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
11162459|NCT01953354|BG001|Baseline|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
11162460|NCT01953354|BG002|Baseline|Total|Total of all reporting groups
11162461|NCT01953354|FG000|Participant Flow|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
11162462|NCT01953354|FG001|Participant Flow|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
11162463|NCT01953354|OG000|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
11162464|NCT01953354|OG001|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
11162465|NCT01953354|EG000|Reported Event|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
11162466|NCT01953354|EG001|Reported Event|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
11162467|NCT01953432|BG000|Baseline|Doxazosin|"Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.~Doxazosin (target 8mg/day) Induction - Week 1: 1mg once daily over days 1--3; 2mg once daily over days 4-7; Week 2: 4mg once daily over days 8-10; 8mg once daily over days 11-14; Week 3: 8mg once daily over days 15-end of week 10~Doxazosin tapered over weeks 11-12 -- Week 11: 4mg on Monday, Tuesday, Wednesday, and Thursday and 1mg for the duration of week 11. During week 12, subjects will receive 1mg on Monday, Tuesday, and Wednesday only. No further medication will be given for the remainder of week 12."
11162468|NCT01953432|BG001|Baseline|Placebo|"Matched placebo daily dosing.~Placebo: Matched placebo daily dosing"
11162469|NCT01953432|BG002|Baseline|Total|Total of all reporting groups
11162470|NCT01953432|FG000|Participant Flow|Doxazosin|"Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.~Doxazosin (target 8mg/day) Induction - Week 1: 1mg once daily over days 1--3; 2mg once daily over days 4-7; Week 2: 4mg once daily over days 8-10; 8mg once daily over days 11-14; Week 3: 8mg once daily over days 15-end of week 10~Doxazosin tapered over weeks 11-12 -- Week 11: 4mg on Monday, Tuesday, Wednesday, and Thursday and 1mg for the duration of week 11. During week 12, subjects will receive 1mg on Monday, Tuesday, and Wednesday only. No further medication will be given for the remainder of week 12."
11162471|NCT01953432|FG001|Participant Flow|Placebo|"Matched placebo daily dosing.~Placebo: Matched placebo daily dosing"
11162472|NCT01953432|OG000|Outcome|Doxazosin|"Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.~Doxazosin (target 8mg/day) Induction - Week 1: 1mg once daily over days 1--3; 2mg once daily over days 4-7; Week 2: 4mg once daily over days 8-10; 8mg once daily over days 11-14; Week 3: 8mg once daily over days 15-end of week 10~Doxazosin tapered over weeks 11-12 -- Week 11: 4mg on Monday, Tuesday, Wednesday, and Thursday and 1mg for the duration of week 11. During week 12, subjects will receive 1mg on Monday, Tuesday, and Wednesday only. No further medication will be given for the remainder of week 12."
11162473|NCT01953432|OG001|Outcome|Placebo|"Matched placebo daily dosing.~Placebo: Matched placebo daily dosing"
11162474|NCT01953432|EG000|Reported Event|Doxazosin|"Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.~Doxazosin: Doxazosin is initiated at 2 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 4 weeks. Participants will be maintained on 8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15."
11162475|NCT01953432|EG001|Reported Event|Placebo|"Matched placebo daily dosing.~Placebo: Matched placebo daily dosing"
11162476|NCT01953575|BG000|Baseline|Active Eosinophilic Esophagitis|"Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy~Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162477|NCT01953575|BG001|Baseline|Inactive Eosinophilic Esophagitis|"Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy~Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162478|NCT01953575|BG002|Baseline|Control Group|"Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162479|NCT01953575|BG003|Baseline|Total|Total of all reporting groups
11162480|NCT01953575|FG000|Participant Flow|Active Eosinophilic Esophagitis|"Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy~Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162481|NCT01953575|FG001|Participant Flow|Inactive Eosinophilic Esophagitis|"Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy~Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162482|NCT01953575|FG002|Participant Flow|Control Group|"Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162483|NCT01953575|OG000|Outcome|Active Eosinophilic Esophagitis|"Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy~Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11228211|NCT02388763|FG001|Participant Flow|Habitual, 1DAVTE, MyDay|Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
11228212|NCT02388763|OG000|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
11162484|NCT01953575|OG001|Outcome|Inactive Eosinophilic Esophagitis|"Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy~Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162485|NCT01953575|OG002|Outcome|Control Group|"Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162486|NCT01953575|EG000|Reported Event|Active Eosinophilic Esophagitis|"Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy~Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162487|NCT01953575|EG001|Reported Event|Inactive Eosinophilic Esophagitis|"Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy~Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162488|NCT01953575|EG002|Reported Event|Control Group|"Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy~Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum."
11162489|NCT01953601|BG000|Baseline|Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2)|[Part 1] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.
11162490|NCT01953601|BG001|Baseline|Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2)|[Part 1] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
11162491|NCT01953601|BG002|Baseline|Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2)|[Part 1] Placebo once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
11162492|NCT01953601|BG003|Baseline|Total|Total of all reporting groups
11162493|NCT01953601|FG000|Participant Flow|Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2)|[Part 1] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.
11162494|NCT01953601|FG001|Participant Flow|Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2)|[Part 1] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
11162495|NCT01953601|FG002|Participant Flow|Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2)|[Part 1] Placebo once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
11162496|NCT01953601|OG000|Outcome|Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2)|[Part 1] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.
11162497|NCT01953601|OG001|Outcome|Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2)|[Part 1] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
11162498|NCT01953601|OG002|Outcome|Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2)|[Part 1] Placebo once daily for 104 weeks in Part 1 (Base Study). [Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
11162499|NCT01953601|EG000|Reported Event|Arm A. Verubecestat 12 mg (Part 1)|[Part 1] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study).
11162500|NCT01953601|EG001|Reported Event|Arm B. Verubecestat 40 mg (Part 1)|[Part 1] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study).
11162501|NCT01953601|EG002|Reported Event|Arm C. Placebo (Part 1)|[Part 1] Placebo once daily for 104 weeks in Part 1 (Base Study).
11162502|NCT01953601|EG003|Reported Event|Arm A. Verubecestat 12 mg (Part 2)|[Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.
11162503|NCT01953601|EG004|Reported Event|Arm B. Verubecestat 40 mg (Part 2)|[Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
11162504|NCT01953601|EG005|Reported Event|Arm C. Verubecestat 40 mg (Part 2)|[Part 2] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
11162505|NCT01953692|BG000|Baseline|Cohort 1: Myelodysplastic Syndrome (MDS)|Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
11162506|NCT01953692|BG001|Baseline|Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162507|NCT01953692|BG002|Baseline|Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162508|NCT01953692|BG003|Baseline|Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162509|NCT01953692|BG004|Baseline|Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162510|NCT01953692|BG005|Baseline|Cohort 4C: R/R Follicular Lymphoma (FL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162511|NCT01953692|BG006|Baseline|Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162512|NCT01953692|BG007|Baseline|Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
11162513|NCT01953692|BG008|Baseline|Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
11162514|NCT01953692|BG009|Baseline|Total|Total of all reporting groups
11162515|NCT01953692|FG000|Participant Flow|Cohort 1: Myelodysplastic Syndrome (MDS)|Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
11162516|NCT01953692|FG001|Participant Flow|Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162517|NCT01953692|FG002|Participant Flow|Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162518|NCT01953692|FG003|Participant Flow|Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162519|NCT01953692|FG004|Participant Flow|Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162520|NCT01953692|FG005|Participant Flow|Cohort 4C: R/R Follicular Lymphoma (FL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162521|NCT01953692|FG006|Participant Flow|Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162522|NCT01953692|FG007|Participant Flow|Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
11162523|NCT01953692|FG008|Participant Flow|Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
11162524|NCT01953692|OG000|Outcome|Cohort 1: Myelodysplastic Syndrome (MDS)|Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
11162525|NCT01953692|OG001|Outcome|Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162526|NCT01953692|OG002|Outcome|Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162527|NCT01953692|OG003|Outcome|Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162528|NCT01953692|OG004|Outcome|Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162529|NCT01953692|OG005|Outcome|Cohort 4C: R/R Follicular Lymphoma (FL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162530|NCT01953692|OG006|Outcome|Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162531|NCT01953692|OG007|Outcome|Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
11162532|NCT01953692|OG008|Outcome|Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
11162533|NCT01953692|OG000|Outcome|Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162534|NCT01953692|OG000|Outcome|Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162535|NCT01953692|OG000|Outcome|Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)|Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162536|NCT01953692|OG000|Outcome|Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162537|NCT01953692|OG001|Outcome|Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162538|NCT01953692|OG002|Outcome|Cohort 4C: R/R Follicular Lymphoma (FL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162539|NCT01953692|OG003|Outcome|Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162540|NCT01953692|OG000|Outcome|Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)|Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
11162541|NCT01953692|OG004|Outcome|Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas|Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
11162542|NCT01953692|OG000|Outcome|Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
11162543|NCT01953692|EG000|Reported Event|Cohort 1: Myelodysplastic Syndrome (MDS)|Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle
11162544|NCT01953692|EG001|Reported Event|Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162545|NCT01953692|EG002|Reported Event|Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162546|NCT01953692|EG003|Reported Event|Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162547|NCT01953692|EG004|Reported Event|Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas|Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
11162548|NCT01953692|EG005|Reported Event|Cohort 4C: R/R Follicular Lymphoma (FL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
11162549|NCT01953692|EG006|Reported Event|Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle
11162550|NCT01953692|EG007|Reported Event|Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
11162551|NCT01953692|EG008|Reported Event|Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
11162552|NCT01953783|BG000|Baseline|Ixazomib|Ixazomib 4.1 milligram (mg) containing approximately 500-nCurie (nCi) of total radioactivity [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21 in Part A. Participants who had completed their Day 35 assessments in Part A were eligible to continue in Part B. Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity in Part B.
11162553|NCT01953783|FG000|Participant Flow|Ixazomib|Ixazomib 4.1 milligram (mg) containing approximately 500-nCurie (nCi) of total radioactivity [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21 in Part A. Participants who had completed their Day 35 assessments in Part A were eligible to continue in Part B. Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity in Part B.
11162554|NCT01953783|OG000|Outcome|Ixazomib|Ixazomib 4.1 milligram (mg) containing approximately 500-nCurie (nCi) of total radioactivity [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21 in Part A. Participants who had completed their Day 35 assessments in Part A were eligible to continue in Part B. Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity in Part B.
11162555|NCT01953783|EG000|Reported Event|Ixazomib|Ixazomib 4.1 milligram (mg) containing approximately 500-nCurie (nCi) of total radioactivity [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21 in Part A. Participants who had completed their Day 35 assessments in Part A were eligible to continue in Part B. Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity in Part B.
11162556|NCT01953874|BG000|Baseline|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11162557|NCT01953874|BG001|Baseline|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11162558|NCT01953874|BG002|Baseline|Total|Total of all reporting groups
11162559|NCT01953874|FG000|Participant Flow|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11162560|NCT01953874|FG001|Participant Flow|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11228213|NCT02388763|OG001|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
11162561|NCT01953874|OG000|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11162562|NCT01953874|OG001|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11162563|NCT01953874|OG000|Outcome|All Subjects|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment compared to optimized medical treatment only~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11162564|NCT01953874|EG000|Reported Event|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11162565|NCT01953874|EG001|Reported Event|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
11162566|NCT01953913|BG000|Baseline|Afatinib|Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
11162567|NCT01953913|FG000|Participant Flow|Afatinib|Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
11162568|NCT01953913|OG000|Outcome|Afatinib|Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
11162569|NCT01953913|EG000|Reported Event|Afatinib|Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28- day treatment cycle.
11162570|NCT01954017|BG000|Baseline|Low Dose STP206|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162571|NCT01954017|BG001|Baseline|High Dose STP206|"Biological~STP206: Live Biotherapeutic~~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162572|NCT01954017|BG002|Baseline|Control|Sterile water
11162573|NCT01954017|BG003|Baseline|Total|Total of all reporting groups
11162574|NCT01954017|FG000|Participant Flow|Low Dose STP206|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162575|NCT01954017|FG001|Participant Flow|High Dose STP206|"Biological~STP206: Live Biotherapeutic~~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162576|NCT01954017|FG002|Participant Flow|Control|Sterile water
11162577|NCT01954017|OG000|Outcome|Group 1a (Birth wt: 2000-1501 g) Low Dose|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162578|NCT01954017|OG001|Outcome|Group 1a (Birth wt: 2000-1501 g) Control|Sterile water
11162579|NCT01954017|OG002|Outcome|Group 2a (Birth wt: 1500-1000 g) Low Dose|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162580|NCT01954017|OG003|Outcome|Group 2a (Birth wt: 1500-1000 g) Control|Sterile water
11162581|NCT01954017|OG004|Outcome|Group 3a (Birth wt: 999-750 g) Low Dose|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162582|NCT01954017|OG005|Outcome|Group 3a (Birth wt: 999-750 g) Control|Sterile water
11162583|NCT01954017|OG006|Outcome|Group 4a (Birth wt: 749-500 g) Low Dose|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162584|NCT01954017|OG007|Outcome|Group 4a (Birth wt: 749-500 g) Control|Sterile water
11162585|NCT01954017|OG000|Outcome|Group 1b (Birth wt: 2000-1501 g) High Dose|"Biological~STP206: Live Biotherapeutic~~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162586|NCT01954017|OG001|Outcome|Group 1b (Birth wt: 2000-1501 g) Control|Sterile water
11162587|NCT01954017|OG002|Outcome|Group 2b (Birth wt: 1500-1000 g) High Dose|"Biological~STP206: Live Biotherapeutic~~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162588|NCT01954017|OG003|Outcome|Group 2b (Birth wt: 1500-1000 g) Control|Sterile water
11162589|NCT01954017|OG004|Outcome|Group 3b (Birth wt: 999-750 g) High Dose|"Biological~STP206: Live Biotherapeutic~~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162590|NCT01954017|OG005|Outcome|Group 3b (Birth wt: 999-750 g) Control|Sterile water
11162591|NCT01954017|OG006|Outcome|Group 4b (Birth wt: 749-500 g) High Dose|"Biological~STP206: Live Biotherapeutic~~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162592|NCT01954017|OG007|Outcome|Group 4b (Birth wt: 749-500 g) Control|Sterile water
11162593|NCT01954017|EG000|Reported Event|Group 1a (Birth wt: 2000-1501 g) Low Dose|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162594|NCT01954017|EG001|Reported Event|Group 1a (Birth wt:2000-1501 g) Control|Sterile water
11162595|NCT01954017|EG002|Reported Event|Group 2a (Birth wt:1500-1000 g) Low Dose|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162596|NCT01954017|EG003|Reported Event|Group 2a (Birth wt:1500-1000 g) Control|Sterile water
11162597|NCT01954017|EG004|Reported Event|Group 3a (Birth wt:999-750 g) Low Dose|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162598|NCT01954017|EG005|Reported Event|Group 3a (Birth wt:999-750 g) Control|Sterile water
11162599|NCT01954017|EG006|Reported Event|Group 4a (Birth wt: 749-500 g) Low Dose|"Biological~STP206: Live Biotherapeutic~~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu)"
11162600|NCT01954017|EG007|Reported Event|Group 4a (Birth wt:749-500 g) Control|Sterile water
11162601|NCT01954017|EG008|Reported Event|Group 1b (Birth wt: 2000-1501 g) High Dose|"Biological~STP206: Live Biotherapeutic~~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162602|NCT01954017|EG009|Reported Event|Group 1b (Birth wt:2000-1501 g) Control|Sterile water
11162603|NCT01954017|EG010|Reported Event|Group 2b (Birth wt: 1500-1000 g) High Dose|"Biological~STP206: Live Biotherapeutic~~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162604|NCT01954017|EG011|Reported Event|Group 2b (Birth wt:1500-1000 g) Control|Sterile water
11228214|NCT02388763|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11162605|NCT01954017|EG012|Reported Event|Group 3b (Birth wt: 999-750 g) High Dose|"Biological~STP206: Live Biotherapeutic~~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162606|NCT01954017|EG013|Reported Event|Group 3b (Birth wt:999-750 g) Control|Sterile water
11162607|NCT01954017|EG014|Reported Event|Group 4b (Birth wt: 749-500 g) High Dose|"Biological~STP206: Live Biotherapeutic~~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu)"
11162608|NCT01954017|EG015|Reported Event|Group 4b (Birth wt:749-500 g) Control|Sterile water
11162609|NCT01954056|BG000|Baseline|Hydrocortisone|"Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
11162610|NCT01954056|BG001|Baseline|Placebo|"Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
11162611|NCT01954056|BG002|Baseline|Total|Total of all reporting groups
11162612|NCT01954056|FG000|Participant Flow|Hydrocortisone|"hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line~Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
11162613|NCT01954056|FG001|Participant Flow|Placebo|"Saline placebo~Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
11162614|NCT01954056|OG000|Outcome|Hydrocortisone|"Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
11162615|NCT01954056|OG001|Outcome|Placebo|"Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
11162616|NCT01954056|EG000|Reported Event|Hydrocortisone|"hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
11162617|NCT01954056|EG001|Reported Event|Placebo|"Saline placebo Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
11162618|NCT01954082|BG000|Baseline|Myo-Inositol 5% Injection|Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally.
11162619|NCT01954082|BG001|Baseline|5% Glucose(Dextrose)|The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol.
11162620|NCT01954082|BG002|Baseline|Total|Total of all reporting groups
11162621|NCT01954082|FG000|Participant Flow|Myo-Inositol 5% Injection|Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally.
11162622|NCT01954082|FG001|Participant Flow|5% Glucose(Dextrose)|The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol.
11162623|NCT01954082|OG000|Outcome|Myo-Inositol 5% Injection|Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally.
11162624|NCT01954082|OG001|Outcome|5% Glucose(Dextrose)|The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol.
11162625|NCT01954082|EG000|Reported Event|Myo-Inositol 5% Injection|Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally.
11162626|NCT01954082|EG001|Reported Event|5% Glucose(Dextrose)|The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol.
11162627|NCT01954121|BG000|Baseline|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
11162628|NCT01954121|BG001|Baseline|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
11162629|NCT01954121|BG002|Baseline|Total Title|
11162630|NCT01954121|FG000|Participant Flow|Levetiracetam|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
11162631|NCT01954121|FG001|Participant Flow|Carbamazepine-IR|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
11162632|NCT01954121|OG000|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
11162633|NCT01954121|OG001|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
11162634|NCT01954121|EG000|Reported Event|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
11162635|NCT01954121|EG001|Reported Event|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
11162636|NCT01954251|BG000|Baseline|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
11162637|NCT01954251|BG001|Baseline|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
11162638|NCT01954251|BG002|Baseline|Total|Total of all reporting groups
11162639|NCT01954251|FG000|Participant Flow|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
11162640|NCT01954251|FG001|Participant Flow|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
11162641|NCT01954251|OG000|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
11162642|NCT01954251|OG001|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
11162643|NCT01954251|OG000|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
11162644|NCT01954251|EG000|Reported Event|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
11162645|NCT01954251|EG001|Reported Event|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
11162646|NCT01954264|BG000|Baseline|Overall Study Group|Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.
11162647|NCT01954264|FG000|Participant Flow|Overall Study Group|Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.
11162648|NCT01954264|OG000|Outcome|0.5-4Y Group|Subjects aged 6 months to 4 years (Y) old, who were infected or not infected with P. falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.
11162649|NCT01954264|OG001|Outcome|5-9Y Group|Subjects aged 5 to 9 years (Y) old, who were infected or not infected with P. falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.
11162650|NCT01954264|OG000|Outcome|Overall Study Group|Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.
11162651|NCT01954264|OG000|Outcome|PF-INF Group|Subjects aged between 6 months to 9 years old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy.
11162652|NCT01954264|OG001|Outcome|NOT-INF Group|Subjects aged between 6 months to 9 years old, who were not infected with P. falciparum parasite (NOT-INF). Infection status was assessed using a blood smear slide and determined using microscopy.
11162653|NCT01954264|OG000|Outcome|PF-INF Group|Subjects aged between 6 months to 9 years (Y) old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy.
11162654|NCT01954264|OG001|Outcome|NOT-INF Group|Subjects aged between 6 months to 9 years (Y) old, who were not infected with P. falciparum parasite (NOT-INF). Infection status was assessed using a blood smear slide and determined using microscopy.
11162655|NCT01954264|OG000|Outcome|0.5-4Y GROUP|Subjects aged between 6 months to 4 years (Y) old, who were infected or not infected with Plasmodium parasites. Infection status was assessed using a blood smear slide and determined using microscopy.
11162656|NCT01954264|OG001|Outcome|5-9Y GROUP|Subjects aged between 5 to 9 years (Y) old, who were infected or not infected with Plasmodium parasites. Infection status was assessed using a blood smear slide and determined using microscopy.
11162657|NCT01954264|OG000|Outcome|Low PD Group|Subjects aged between 6 months to 9 years old, with low P. falciparum parasite density (<2500 parasite per µL).
11162658|NCT01954264|OG001|Outcome|Medium PD Group|Subjects aged between 6 months to 9 years old, with medium P. falciparum parasite density (2500 - 9999 parasite per µL).
11162659|NCT01954264|OG002|Outcome|High PD Group|Subjects aged between 6 months to 9 years old, with high P. falciparum parasite density (10000 - 19999 parasite per µL).
11162660|NCT01954264|OG003|Outcome|Vhigh PD Group|Subjects aged between 6 months to 9 years old, with very high P. falciparum parasite density (≥20000 parasite per µL).
11162661|NCT01954264|OG004|Outcome|Neg PD Group|Subjects aged between 6 months to 9 years old, who were not infected with P. falciparum parasite.
11162662|NCT01954264|EG000|Reported Event|Overall Study Group|Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.
11162663|NCT01954342|BG000|Baseline|Pregnant Women With Excess Gestational Weight Gain|Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
11162664|NCT01954342|BG001|Baseline|Pregnant Women With Recommended Gestational Weight Gain|Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
11162665|NCT01954342|BG002|Baseline|Pregnant Women With Inadequate Gestational Weight Gain|Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
11162666|NCT01954342|BG003|Baseline|Pregnant Women Not Included in Analysis|Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
11162667|NCT01954342|BG004|Baseline|Total|Total of all reporting groups
11162668|NCT01954342|FG000|Participant Flow|Pregnant Women With Excess Gestational Weight Gain|Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
11162669|NCT01954342|FG001|Participant Flow|Pregnant Women With Recommended Gestational Weight Gain|Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
11162670|NCT01954342|FG002|Participant Flow|Pregnant Women With Inadequate Gestational Weight Gain|Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
11162671|NCT01954342|FG003|Participant Flow|Pregnant Women Not Included in Analysis|Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
11162672|NCT01954342|OG000|Outcome|Pregnant Women With Excess Gestational Weight Gain|Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
11162673|NCT01954342|OG001|Outcome|Pregnant Women With Recommended Gestational Weight Gain|Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
11162674|NCT01954342|OG002|Outcome|Pregnant Women With Inadequate Gestational Weight Gain|Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
11162675|NCT01954342|OG003|Outcome|Pregnant Women Not Included in Analysis|Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
11162676|NCT01954342|EG000|Reported Event|Pregnant Women With Excess Gestational Weight Gain|Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
11162677|NCT01954342|EG001|Reported Event|Pregnant Women With Recommended Gestational Weight Gain|Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
11162678|NCT01954342|EG002|Reported Event|Pregnant Women With Inadequate Gestational Weight Gain|Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
11162679|NCT01954342|EG003|Reported Event|Pregnant Women Not Included in Analysis|Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
11162680|NCT01954394|BG000|Baseline|Placebo to Alirocumab 75 or 150 mg Q2W|Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
11162681|NCT01954394|BG001|Baseline|Alirocumab to Alirocumab 75 or 150 mg Q2W|Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
11162682|NCT01954394|BG002|Baseline|Total|Total of all reporting groups
11162683|NCT01954394|FG000|Participant Flow|Placebo to Alirocumab 75 or 150 mg Q2W|Alirocumab 75 mg or 150 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values.
11162684|NCT01954394|FG001|Participant Flow|Alirocumab to Alirocumab 75 or 150 mg Q2W|Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
11162685|NCT01954394|OG000|Outcome|Placebo to Alirocumab 75 or 150 mg Q2W|Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
11162686|NCT01954394|OG001|Outcome|Alirocumab to Alirocumab 75 or 150 mg Q2W|Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
11162687|NCT01954394|OG002|Outcome|Alirocumab: All Participants|All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
11162688|NCT01954394|EG000|Reported Event|Placebo to Alirocumab 75 or 150 mg Q2W|Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
11162689|NCT01954394|EG001|Reported Event|Alirocumab to Alirocumab 75 or 150 mg Q2W|Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
11162690|NCT01954394|EG002|Reported Event|Alirocumab: All Participants|All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in this study.
11162691|NCT01954628|BG000|Baseline|AQX-1125 (200 mg)|"1 x AQX-1125 capsule daily~AQX-1125: Synthetic SHIP1 activator"
11162692|NCT01954628|BG001|Baseline|Placebo|"1 x Placebo capsule daily~Placebo: Placebo control"
11162693|NCT01954628|BG002|Baseline|Total|Total of all reporting groups
11162694|NCT01954628|FG000|Participant Flow|AQX-1125 (200 mg)|AQX-1125 (200 mg capsule), oral once daily for 12 weeks. All standard of care treatments for COPD were permitted throughout the study with the exception of Roflumilast and Theophylline.
11162695|NCT01954628|FG001|Participant Flow|Placebo|Placebo (matching AQX-1125 capsule), oral, once daily for 12 weeks. Placebo control. All standard of care treatments for COPD were permitted throughout the study with the exception of Roflumilast and Theophylline.
11162696|NCT01954628|OG000|Outcome|AQX-1125 (200mg)|1 x AQX-1125 capsule daily
11162697|NCT01954628|OG001|Outcome|Placebo|1 x Placebo capsule daily
11162698|NCT01954628|OG000|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
11162699|NCT01954628|OG000|Outcome|AQX-1125 Week 2|AQX-1125 Week 2 PK
11162700|NCT01954628|OG001|Outcome|AQX-1125 Week 4|AQX-1125 Week 4 PK
11162701|NCT01954628|OG002|Outcome|AQX-1125 Week 12|Week 12 PK Week 12 PK
11162702|NCT01954628|EG000|Reported Event|AQX-1125|"1 x AQX-1125 capsule daily~AQX-1125: Synthetic SHIP1 activator"
11162703|NCT01954628|EG001|Reported Event|Placebo|"1 x Placebo capsule daily~Placebo: Placebo control"
11162704|NCT01954745|BG000|Baseline|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
11162705|NCT01954745|FG000|Participant Flow|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
11162706|NCT01954745|OG000|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
11162707|NCT01954745|EG000|Reported Event|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
11162708|NCT01954771|BG000|Baseline|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162709|NCT01954771|BG001|Baseline|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162710|NCT01954771|BG002|Baseline|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162711|NCT01954771|BG003|Baseline|Total|Total of all reporting groups
11162712|NCT01954771|FG000|Participant Flow|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162713|NCT01954771|FG001|Participant Flow|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11228215|NCT02388763|EG001|Reported Event|Dailies Total 1|Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
11228216|NCT02388763|EG002|Reported Event|Clariti 1-Day|Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
11228217|NCT02388763|EG003|Reported Event|MyDay|Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
11162714|NCT01954771|FG002|Participant Flow|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162715|NCT01954771|OG000|Outcome|Control Group|"SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162716|NCT01954771|OG001|Outcome|SMBG-4 Group|"SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162717|NCT01954771|OG002|Outcome|SMBG-7 Group|"SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162718|NCT01954771|OG000|Outcome|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162719|NCT01954771|OG001|Outcome|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162720|NCT01954771|OG002|Outcome|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162721|NCT01954771|EG000|Reported Event|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162722|NCT01954771|EG001|Reported Event|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162723|NCT01954771|EG002|Reported Event|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
11162724|NCT01954927|BG000|Baseline|Gabapentin|"Participants were randomized to receive one dose of gabapentin.~Gabapentin: Gabapentin is supplied as an oral suspension. Patients randomized to the gabapentin arm received a single dose of gabapentin as soon after enrollment as feasible, given orally, approximately 15 milligram/kilogram (mg/kg) with a maximum dose of 900 milligram (mg)."
11162725|NCT01954927|BG001|Baseline|Placebo|"Participants were randomized to receive one dose of placebo.~Placebo: Placebo was prepared by the SJCRH pharmacy, similar in appearance, quantity and taste to the gabapentin drug. Patients randomized to the placebo arm received a single dose of placebo as soon after enrollment as feasible, given orally, in a volume that matched the active medication arm."
11162726|NCT01954927|BG002|Baseline|Total|Total of all reporting groups
11162727|NCT01954927|FG000|Participant Flow|Gabapentin|"Participants were randomized to receive one dose of gabapentin.~Gabapentin: Gabapentin is supplied as an oral suspension. Patients randomized to the gabapentin arm received a single dose of gabapentin as soon after enrollment as feasible, given orally, approximately 15 milligram/kilogram (mg/kg) with a maximum dose of 900 milligram (mg)."
11162728|NCT01954927|FG001|Participant Flow|Placebo|"Participants were randomized to receive one dose of placebo.~Placebo: Placebo was prepared by the SJCRH pharmacy, similar in appearance, quantity and taste to the gabapentin drug. Patients randomized to the placebo arm received a single dose of placebo as soon after enrollment as feasible, given orally, in a volume that matched the active medication arm."
11228218|NCT02388763|EG004|Reported Event|1DAVTE|Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
11162729|NCT01954927|OG000|Outcome|Gabapentin|"Participants were randomized to receive one dose of gabapentin.~Gabapentin: Gabapentin is supplied as an oral suspension. Patients randomized to the gabapentin arm received a single dose of gabapentin as soon after enrollment as feasible, given orally, approximately 15 mg/kg with a maximum dose of 900 mg."
11162730|NCT01954927|OG001|Outcome|Placebo|"Participants were randomized to receive one dose of placebo.~Placebo: Placebo was prepared by the SJCRH pharmacy, similar in appearance, quantity and taste to the gabapentin drug. Patients randomized to the placebo arm received a single dose of placebo as soon after enrollment as feasible, given orally, in a volume that matched the active medication arm."
11162731|NCT01954927|EG000|Reported Event|Gabapentin|"Participants were randomized to receive one dose of gabapentin.~Gabapentin: Gabapentin is supplied as an oral suspension. Patients randomized to the gabapentin arm received a single dose of gabapentin as soon after enrollment as feasible, given orally, approximately 15 mg/kg with a maximum dose of 900 mg."
11162732|NCT01954927|EG001|Reported Event|Placebo|"Participants were randomized to receive one dose of placebo.~Placebo: Placebo was prepared by the SJCRH pharmacy, similar in appearance, quantity and taste to the gabapentin drug. Patients randomized to the placebo arm received a single dose of placebo as soon after enrollment as feasible, given orally, in a volume that matched the active medication arm."
11162733|NCT01955005|BG000|Baseline|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
11162734|NCT01955005|BG001|Baseline|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
11162735|NCT01955005|BG002|Baseline|Total|Total of all reporting groups
11162736|NCT01955005|FG000|Participant Flow|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
11162737|NCT01955005|FG001|Participant Flow|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
11162738|NCT01955005|OG000|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
11162739|NCT01955005|OG001|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
11162740|NCT01955005|EG000|Reported Event|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
11162741|NCT01955005|EG001|Reported Event|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
11162742|NCT01955044|BG000|Baseline|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
11162743|NCT01955044|BG001|Baseline|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
11162744|NCT01955044|BG002|Baseline|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
11162745|NCT01955044|BG003|Baseline|Total|Total of all reporting groups
11162746|NCT01955044|FG000|Participant Flow|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
11162747|NCT01955044|FG001|Participant Flow|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
11162748|NCT01955044|FG002|Participant Flow|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
11162749|NCT01955044|OG000|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
11162750|NCT01955044|OG001|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
11162751|NCT01955044|OG002|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
11162752|NCT01955044|EG000|Reported Event|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
11162753|NCT01955044|EG001|Reported Event|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
11162754|NCT01955044|EG002|Reported Event|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
11162755|NCT01955083|BG000|Baseline|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
11162756|NCT01955083|BG001|Baseline|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
11162757|NCT01955083|BG002|Baseline|Total|Total of all reporting groups
11162758|NCT01955083|FG000|Participant Flow|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Subjects receive radiofrequency under local anesthesia as an outpatient procedure on sitting position. radiofrequency energy was delivered via a generator (Somnus® Model S2, Gyrus-ACMI Corporation, Maple Grove, MN, USA) with the power set to 10 watts and the maximal target temperature to 85°C. The needle electrode was inserted through the mucosa into the muscle layer at the entry points (approximately 1 cm below the hard palate-soft palate junction). The electrode was kept in place until 600 J had been delivered at the midline and 300 J at both para-midline sites (approximately 1 cm horizontal distance)."
11162759|NCT01955083|FG001|Participant Flow|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Subjects receive pillar implant of the soft palate under local anesthesia as an outpatient procedure on sitting position. Using the delivery tool of the pillar implant system, the mucosa of the soft palate close to the hard palate-soft palate junction (approximate 0.5 cm) was punctured in the midline. The needle was inserted to the uvular muscle and moved parallel to the curve of the soft palate towards the tip of the uvula. After reaching the insertion point, the implant was delivered steadily after which the needle was withdrawn. This process was repeated for the second and third implants in the bilateral para-midline with a 0.2 cm horizontal distance from the first implant."
11162760|NCT01955083|OG000|Outcome|Change in VAS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
11162761|NCT01955083|OG001|Outcome|Change in VAS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
11162762|NCT01955083|OG000|Outcome|Change in SOS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
11162763|NCT01955083|OG001|Outcome|Change in SOS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
11162764|NCT01955083|OG000|Outcome|Percent Change in Total-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
11162765|NCT01955083|OG001|Outcome|Percent Change in Total-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
11162766|NCT01955083|OG000|Outcome|Percent Change in Total-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
11349189|NCT04113785|BG000|Baseline|Klassic TKA|"Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.~Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee"
11162767|NCT01955083|OG001|Outcome|Percent Change in Total-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
11162768|NCT01955083|OG000|Outcome|Percent Change in Total-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
11162769|NCT01955083|OG001|Outcome|Percent Change in Total-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
11162770|NCT01955083|OG000|Outcome|Percent Change in Total-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
11162771|NCT01955083|OG001|Outcome|Percent Change in Total-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
11162772|NCT01955083|OG000|Outcome|Percent Change in Total-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
11162773|NCT01955083|OG001|Outcome|Percent Change in Total-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
11162774|NCT01955083|OG000|Outcome|Percent Change in B1-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
11162775|NCT01955083|OG001|Outcome|Percent Change in B1-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
11162776|NCT01955083|OG000|Outcome|Percent Change in B1-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
11162777|NCT01955083|OG001|Outcome|Percent Change in B1-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
11162778|NCT01955083|OG000|Outcome|Percent Change in B1-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
11162779|NCT01955083|OG001|Outcome|Percent Change in B1-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
11162780|NCT01955083|OG000|Outcome|Percent Change in B1-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
11162781|NCT01955083|OG001|Outcome|Percent Change in B1-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
11162782|NCT01955083|OG000|Outcome|Percent Change in B1-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
11162783|NCT01955083|OG001|Outcome|Percent Change in B1-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
11162784|NCT01955083|OG000|Outcome|Percentage of Good Response at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percentage of good response was calculated."
11162785|NCT01955083|OG001|Outcome|Percentage of Good Response at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percentage of good response at 3 months after surgery was calculated."
11162786|NCT01955083|EG000|Reported Event|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
11162787|NCT01955083|EG001|Reported Event|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
11162788|NCT01955122|BG000|Baseline|Group A|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
11162789|NCT01955122|BG001|Baseline|Group B|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device) .
11162790|NCT01955122|BG002|Baseline|Total|Total of all reporting groups
11162791|NCT01955122|FG000|Participant Flow|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
11162792|NCT01955122|FG001|Participant Flow|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
11162793|NCT01955122|OG000|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
11162794|NCT01955122|OG001|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
11162795|NCT01955122|OG000|Outcome|EndoRings Colonoscopy|procedures performed with the EndoRings
11162796|NCT01955122|OG001|Outcome|Standard Colonoscopy|procedures performed with the Standard
11162797|NCT01955122|OG000|Outcome|Group A|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
11162798|NCT01955122|OG001|Outcome|Group B|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
11162799|NCT01955122|OG000|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.~Tandem Colonoscopy: Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order."
11162800|NCT01955122|OG001|Outcome|Group B|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.~Tandem Colonoscopy: Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order."
11162801|NCT01955122|EG000|Reported Event|A (Study Group)|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
11162802|NCT01955122|EG001|Reported Event|Group B (Control Group)|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
11162803|NCT01955161|BG000|Baseline|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
11162804|NCT01955161|BG001|Baseline|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11162805|NCT01955161|BG002|Baseline|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11162806|NCT01955161|BG003|Baseline|Total|Total of all reporting groups
11162807|NCT01955161|FG000|Participant Flow|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
11162808|NCT01955161|FG001|Participant Flow|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11162809|NCT01955161|FG002|Participant Flow|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11162810|NCT01955161|OG000|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
11162811|NCT01955161|OG001|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11162812|NCT01955161|OG002|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11162813|NCT01955161|EG000|Reported Event|Placebo|Placebo adjunct to 10 mg Donepezil
11162814|NCT01955161|EG001|Reported Event|Idalopirdine 30 mg|Idalopirdine adjunct to 10 mg Donezepil
11162815|NCT01955161|EG002|Reported Event|Idalopirdine 60 mg|Idalopirdine adjunct to 10 mg Donezepil
11162816|NCT01955369|BG000|Baseline|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
11162817|NCT01955369|FG000|Participant Flow|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
11162818|NCT01955369|OG000|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
11162819|NCT01955369|EG000|Reported Event|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
11162820|NCT01955382|BG000|Baseline|AS + oAC|All children in the AS+oAC group will receive artesunate (AS) 2.4 mg/kg IV at 0, 12, 24, and 48 h, and weight-based doses of oral activated charcoal (oAC; Actidose Aqua; according to Table 1) at 0, 6, 12, and 18 h. All children will then receive age-based doses of amodiaquine.
11162821|NCT01955382|BG001|Baseline|AS Only (Water)|All children in the AS Only group will receive artesunate (AS) 2.4 mg/kg IV at 0, 12, 24, and 48 h, and weight-based volumes of clean water at 0, 6, 12, and 18 h. All children will then receive age-based doses of amodiaquine.
11162822|NCT01955382|BG002|Baseline|Total|Total of all reporting groups
11162823|NCT01955382|FG000|Participant Flow|AS + oAC|"All children will receive Artesunate (AS) 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h. All children will then receive amodiaquine.~Actidose Aqua: Actidose Aqua (oAC, Paddock Laboratories) is sold over the counter in the US in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses."
11162824|NCT01955382|FG001|Participant Flow|AS Only (Water)|"Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions."
11162825|NCT01955382|OG000|Outcome|AS + oAC|"All children will receive Artesunate (AS) 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h. All children will then receive amodiaquine.~Actidose Aqua: Actidose Aqua (oAC, Paddock Laboratories) is sold over the counter in the US in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses."
11228219|NCT02388815|BG000|Baseline|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11162826|NCT01955382|OG001|Outcome|AS Only (Water)|"Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions."
11162827|NCT01955382|OG000|Outcome|AS + oAC|"All children will receive Artesunate (AS) 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h. All children will then receive amodiaquine.~Actidose Aqua: Actidose Aqua (oAC) (Paddock Laboratories is sold over the counter in the US in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses."
11162828|NCT01955382|EG000|Reported Event|AS + oAC|"All children will receive Artesunate (AS) 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h. All children will then receive amodiaquine.~Actidose Aqua: Actidose Aqua (oAC) (Paddock Laboratories is sold over the counter in the US in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses."
11162829|NCT01955382|EG001|Reported Event|AS Only (Water)|"Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions."
11162830|NCT01955434|BG000|Baseline|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11162831|NCT01955434|FG000|Participant Flow|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11162832|NCT01955434|OG000|Outcome|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11162833|NCT01955434|EG000|Reported Event|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11162834|NCT01955473|BG000|Baseline|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162835|NCT01955473|BG001|Baseline|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162836|NCT01955473|BG002|Baseline|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
10887775|NCT00502671|OG000|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
11162837|NCT01955473|BG003|Baseline|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162838|NCT01955473|BG004|Baseline|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162839|NCT01955473|BG005|Baseline|Total|Total of all reporting groups
11162840|NCT01955473|FG000|Participant Flow|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162841|NCT01955473|FG001|Participant Flow|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162842|NCT01955473|FG002|Participant Flow|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162843|NCT01955473|FG003|Participant Flow|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162844|NCT01955473|FG004|Participant Flow|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162845|NCT01955473|OG000|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162846|NCT01955473|OG001|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162847|NCT01955473|OG002|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162848|NCT01955473|OG003|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162849|NCT01955473|OG004|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162850|NCT01955473|OG003|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162851|NCT01955473|OG000|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162852|NCT01955473|OG000|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162853|NCT01955473|OG001|Outcome|Part A and B Combined|All subjects who were included in Part A and Part B. Sym004 administered by intravenous infusion at a dose of 6 mg/kg weekly, or 9 mg/kg at Week 1 followed by a maintenance dose of 6 mg/kg weekly, or 12 mg/kg weekly, or 18 mg/kg biweekly in Part A or 12 mg/kg by intravenous infusion weekly in Part B until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162854|NCT01955473|EG000|Reported Event|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162855|NCT01955473|EG001|Reported Event|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162856|NCT01955473|EG002|Reported Event|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162857|NCT01955473|EG003|Reported Event|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162858|NCT01955473|EG004|Reported Event|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
11162859|NCT01955564|BG000|Baseline|Placebo|placebo: single dose
11162860|NCT01955564|BG001|Baseline|Cohort 1|"NW-3509a - 1mg~NW-3509a: single dose"
11162861|NCT01955564|BG002|Baseline|Cohort 2|"NW-3509a 2mg~NW-3509a: single dose"
11162862|NCT01955564|BG003|Baseline|Cohort 3|"NW-3509a 5mg~NW-3509a: single dose"
11162863|NCT01955564|BG004|Baseline|Cohort 4|"NW-3509a 10 mg~NW-3509a: single dose"
11162864|NCT01955564|BG005|Baseline|Cohort 5|"NW-3509a 20 mg~NW-3509a: single dose"
11162865|NCT01955564|BG006|Baseline|Cohort 6|NW-3509a 30 mg NW-3509a: single dose
11162866|NCT01955564|BG007|Baseline|Total|Total of all reporting groups
11162867|NCT01955564|FG000|Participant Flow|Placebo|Placebo, single dose
11162868|NCT01955564|FG001|Participant Flow|Cohort 1|NW-3509a - 1mg, single dose
11162869|NCT01955564|FG002|Participant Flow|Cohort 2|NW-3509a 2mg, single dose
11162870|NCT01955564|FG003|Participant Flow|Cohort 3|NW-3509a 5mg, single dose
11162871|NCT01955564|FG004|Participant Flow|Cohort 4|NW-3509a 10 mg, single dose
11162872|NCT01955564|FG005|Participant Flow|Cohort 5|NW-3509a 20 mg, single dose
11162873|NCT01955564|FG006|Participant Flow|Cohort 6|NW-3509a 30 mg, single dose
11162874|NCT01955564|OG000|Outcome|Placebo|Placebo, single dose
11162875|NCT01955564|OG001|Outcome|Cohort 1|NW-3509a - 1mg, single dose
11162876|NCT01955564|OG002|Outcome|Cohort 2|NW-3509a 2mg, single dose
11162877|NCT01955564|OG003|Outcome|Cohort 3|NW-3509a 5mg, single dose
11162878|NCT01955564|OG004|Outcome|Cohort 4|NW-3509a 10 mg, single dose
11162879|NCT01955564|OG005|Outcome|Cohort 5|NW-3509a 20 mg, single dose
11162880|NCT01955564|OG006|Outcome|Cohort 6|NW-3509a 30 mg, single dose
11162881|NCT01955564|OG000|Outcome|Cohort 1|NW-3509a 1mg, single dose
11162882|NCT01955564|OG001|Outcome|Cohort 2|NW-3509a 2mg, single dose
11162883|NCT01955564|OG002|Outcome|Cohort 3|NW-3509a 5mg, single dose
11162884|NCT01955564|OG003|Outcome|Cohort 4|NW-3509a 10mg, single dose
11162885|NCT01955564|OG004|Outcome|Cohort 5|NW-3509a 20mg, single dose
11162886|NCT01955564|OG005|Outcome|Cohort 6|NW-3509a 30mg, single dose
11162887|NCT01955564|EG000|Reported Event|Placebo|placebo, single dose
11162888|NCT01955564|EG001|Reported Event|Cohort 1|NW-3509a 1mg, single dose
11162889|NCT01955564|EG002|Reported Event|Cohort 2|NW-3509a 2mg, single dose
11162890|NCT01955564|EG003|Reported Event|Cohort 3|NW-3509a 5mg, single dose
11162891|NCT01955564|EG004|Reported Event|Cohort 4|NW-3509a 10 mg, single dose
11162892|NCT01955564|EG005|Reported Event|Cohort 5|NW-3509a 20 mg, single dose
11162893|NCT01955564|EG006|Reported Event|Cohort 6|NW-3509a 30 mg, single dose
11162894|NCT01955629|BG000|Baseline|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
11162895|NCT01955629|FG000|Participant Flow|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous (IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
11162896|NCT01955629|OG000|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
11162897|NCT01955629|EG000|Reported Event|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous(IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
11162898|NCT01955707|BG000|Baseline|Placebo|A single IV injection of placebo
11162899|NCT01955707|BG001|Baseline|Natalizumab|300 mg single IV injection of natalizumab
11162900|NCT01955707|BG002|Baseline|Total|Total of all reporting groups
11162901|NCT01955707|FG000|Participant Flow|Placebo|A single intravenous (IV) injection of placebo
11162902|NCT01955707|FG001|Participant Flow|Natalizumab|300 mg single IV injection of natalizumab
11162903|NCT01955707|OG000|Outcome|Placebo|A single IV injection of placebo
11162904|NCT01955707|OG001|Outcome|Natalizumab|300 mg single IV injection of natalizumab
11162905|NCT01955707|EG000|Reported Event|Placebo|A single IV injection of placebo
11162906|NCT01955707|EG001|Reported Event|Natalizumab|300 mg single IV injection of natalizumab
11162907|NCT01955720|BG000|Baseline|Total Subjects Group|The total subjects group contains the following sub-groups: high dose (5 g idarucizumab), healthy, aged 45-64 yrs: high dose (5 g idarucizumab), healthy elderly, aged 65-80 yrs: high dose (5 g idarucizumab), mild renal impairment (RI), aged 45-80 yrs: high dose (2.5 g + 2.5 g idarucizumab), with moderate RI, aged 45-80 yrs: medium dose (2.5 g idarucizumab), healthy, aged 45-64 yrs: low dose (1 g idarucizumab), healthy elderly, aged 65-80 yrs: low dose (1 g idarucizumab), with mild RI, aged 45-80 yrs.
11162908|NCT01955720|FG000|Participant Flow|5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus idarucizumab (Ida) 5g followed by dabigatran 220 mg plus placebo 5g (high dose)
11162909|NCT01955720|FG001|Participant Flow|Placebo / 5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 5g followed by dabigatran 220 mg plus Ida 5g (high dose)
11162910|NCT01955720|FG002|Participant Flow|2.5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 2.5g followed by dabigatran 220 mg plus placebo 2.5g (medium dose)
11162911|NCT01955720|FG003|Participant Flow|Placebo / 2.5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 2.5g followed by dabigatran 220 mg plus Ida 2.5g (medium dose)
11162912|NCT01955720|FG004|Participant Flow|1 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 1g followed by dabigatran 220 mg plus placebo 1g (low dose)
11162913|NCT01955720|FG005|Participant Flow|Placebo / 1 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 1g followed by dabigatran 220 mg plus Ida 1g (low dose)
11162914|NCT01955720|OG000|Outcome|Placebo|idarucizumab-matching placebo
11162915|NCT01955720|OG001|Outcome|Idarucizumab (Ida)|Idarucizumab (Ida).
11162916|NCT01955720|OG000|Outcome|On Treatment Group|during the treatment period.
11162917|NCT01955720|OG000|Outcome|220 mg/2.5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
11162918|NCT01955720|OG001|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
11162919|NCT01955720|OG002|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
11162920|NCT01955720|OG003|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
11162921|NCT01955720|OG004|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
11162922|NCT01955720|OG005|Outcome|150 mg/1 g Mild Renal Impairment (RI)|Mild RI (creatinine clearance [CL] 60-90) with dabigatran (DE) 150 mg/Ida 1g
11162923|NCT01955720|OG006|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
11162924|NCT01955720|OG007|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
11162925|NCT01955720|OG000|Outcome|220 mg/2.5g HS 45-64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
11162926|NCT01955720|OG001|Outcome|220 mg/Plc. 2.5g HS 45-64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
11162927|NCT01955720|OG002|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
11162928|NCT01955720|OG003|Outcome|220 mg/5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g
11162929|NCT01955720|OG004|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
11162930|NCT01955720|OG005|Outcome|220 mg/1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
11162931|NCT01955720|OG006|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
11162932|NCT01955720|OG007|Outcome|220 mg/5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
11162933|NCT01955720|OG008|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
11162934|NCT01955720|OG009|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
11162935|NCT01955720|OG010|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
11162936|NCT01955720|OG011|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
11162937|NCT01955720|OG012|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
11162938|NCT01955720|OG013|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
11162939|NCT01955720|OG014|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
11162940|NCT01955720|OG000|Outcome|220 mg/2.5g HS 45-64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
11162941|NCT01955720|OG001|Outcome|220 mg/Plc. 2.5g HS 45-64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
11162942|NCT01955720|OG002|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
11162943|NCT01955720|OG003|Outcome|220 mg/5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
11162944|NCT01955720|OG004|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
11162945|NCT01955720|OG005|Outcome|220 mg/1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
11162946|NCT01955720|OG006|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
11162947|NCT01955720|OG007|Outcome|220 mg/5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
11162948|NCT01955720|OG008|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
11162949|NCT01955720|OG000|Outcome|220 mg/2.5 g HS 45-64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
11162950|NCT01955720|OG005|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
11162951|NCT01955720|EG000|Reported Event|Dabigatran Etexilate (DE)|subjects with Dabigatran etexilate (DE) treatment
11162952|NCT01955720|EG001|Reported Event|Low (1g) Idarucizumab Dose|Subjects with low 1g idarucizumab dose treatment
11162953|NCT01955720|EG002|Reported Event|Medium (2.5g) Idarucizumab Dose|Subjects with medium (2.5g) idarucizumab dose treatment
11162954|NCT01955720|EG003|Reported Event|High (5g) Idarucizumab Dose|Subjects with high (5g) idarucizumab dose treatment
11162955|NCT01955720|EG004|Reported Event|Low (1g) Placebo Dose|Subjects with low (1g) placebo dose treatment
11162956|NCT01955720|EG005|Reported Event|Medium (2.5g) Placebo Dose|Subjects with medium (2.5g) placebo dose treatment
11162957|NCT01955720|EG006|Reported Event|High (5g) Placebo Dose|Subjects with high (5g) placebo dose treatment
11162958|NCT01955733|BG000|Baseline|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
11162959|NCT01955733|BG001|Baseline|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
11162960|NCT01955733|BG002|Baseline|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
11162961|NCT01955733|BG003|Baseline|Total|Total of all reporting groups
11162962|NCT01955733|FG000|Participant Flow|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
11162963|NCT01955733|FG001|Participant Flow|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
11162964|NCT01955733|FG002|Participant Flow|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
11162965|NCT01955733|OG000|Outcome|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
11162966|NCT01955733|OG001|Outcome|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
11162967|NCT01955733|OG002|Outcome|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
11162968|NCT01955733|EG000|Reported Event|BI 695500|The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
11162969|NCT01955733|EG001|Reported Event|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
11162970|NCT01955733|EG002|Reported Event|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
11162971|NCT01955837|BG000|Baseline|TAS-102（Trifluridine/Tipiracil）|TAS-102 (35 mg/m2/dose) was administered orally in continuous 28-day treatment cycles until a discontinuation criterion was met. One treatment cycle of TAS-102 (35mg/m2/dose) involved administration of dose twice per day, after morning and evening meals, for 5 days a week, with 2 rest days, for 2 weeks, followed by a 14-day rest period. Survival follow-up could be extended until the target number of events (288 deaths) was reached.
11162972|NCT01955837|BG001|Baseline|Placebo|placebo was administered orally in continuous 28-day treatment cycles until a discontinuation criterion was met. One treatment cycle of placebo involved administration of dose twice per day, after morning and evening meals, for 5 days a week, with 2 rest days, for 2 weeks, followed by a 14-day rest period. Survival follow-up could be extended until the target number of events (288 deaths) was reached.
11162973|NCT01955837|BG002|Baseline|Total|Total of all reporting groups
11162974|NCT01955837|FG000|Participant Flow|TAS-102（Trifluridine/Tipiracil）|Trifluridine/Tipiracil (TAS-102) (35 mg/m2/dose) was administered orally in continuous 28-day treatment cycles until a discontinuation criterion was met. One treatment cycle of TAS-102 (35mg/m2/dose) involved administration of dose twice per day, after morning and evening meals, for 5 days a week, with 2 rest days, for 2 weeks, followed by a 14-day rest period. Survival follow-up could be extended until the target number of events (288 deaths) was reached.
11162975|NCT01955837|FG001|Participant Flow|Placebo|placebo was administered orally in continuous 28-day treatment cycles until a discontinuation criterion was met. One treatment cycle of placebo involved administration of dose twice per day, after morning and evening meals, for 5 days a week, with 2 rest days, for 2 weeks, followed by a 14-day rest period. Survival follow-up could be extended until the target number of events (288 deaths) was reached.
11162976|NCT01955837|OG000|Outcome|TAS-102（Trifluridine/Tipiracil）|TAS-102 (35 mg/m2/dose) was administered orally in continuous 28-day treatment cycles until a discontinuation criterion was met. One treatment cycle of TAS-102 (35mg/m2/dose) involved administration of dose twice per day, after morning and evening meals, for 5 days a week, with 2 rest days, for 2 weeks, followed by a 14-day rest period. Survival follow-up could be extended until the target number of events (288 deaths) was reached.
11162977|NCT01955837|OG001|Outcome|Placebo|placebo was administered orally in continuous 28-day treatment cycles until a discontinuation criterion was met. One treatment cycle of placebo involved administration of dose twice per day, after morning and evening meals, for 5 days a week, with 2 rest days, for 2 weeks, followed by a 14-day rest period. Survival follow-up could be extended until the target number of events (288 deaths) was reached.
11162978|NCT01955837|EG000|Reported Event|TAS-102|TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
11162979|NCT01955837|EG001|Reported Event|Placebo|Placebo: Placebo orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
11162980|NCT01955954|BG000|Baseline|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
11162981|NCT01955954|FG000|Participant Flow|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
11162982|NCT01955954|OG000|Outcome|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
11162983|NCT01955954|EG000|Reported Event|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
11162984|NCT01956032|BG000|Baseline|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
11162985|NCT01956032|FG000|Participant Flow|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
11162986|NCT01956032|OG000|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
11162987|NCT01956032|EG000|Reported Event|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
11162988|NCT01956071|BG000|Baseline|Pedal Desk Acceptability|"Orientation sessions will last approximately 30 minutes and will provide participants detailed information about the study, including the number and type of assessments, the length and nature of the pedal desk trial session, the time commitment required, and the potential risks and benefits of participation. Participants will be given a copy of the informed consent form to read and review. Interested participants will schedule their 30 minute trial visit.~At the trial visit, participants' questions will be answered and they will be asked to complete the informed consent form prior to beginning any study procedures. At this one and only visit height, weight, body fat percentage, and Bioelectrical Impedance Analysis will be measured. Participants will also be asked to complete 3 computer based tasks while using the pedal desk (1) search a topic on the internet; (2) compose and send an email, and (3) complete an on-line questionnaire while utilizing the pedal desk."
11162989|NCT01956071|FG000|Participant Flow|Pedal Desk Acceptability|"Orientation sessions will last approximately 30 minutes and will provide participants detailed information about the study, including the number and type of assessments, the length and nature of the pedal desk trial session, the time commitment required, and the potential risks and benefits of participation. Participants will be given a copy of the informed consent form to read and review. Interested participants will schedule their 30 minute trial visit.~At the trial visit, participants' questions will be answered and they will be asked to complete the informed consent form prior to beginning any study procedures. At this one and only visit height, weight, body fat percentage, and Bioelectrical Impedance Analysis will be measured. Participants will also be asked to complete 3 computer based tasks while using the pedal desk (1) search a topic on the internet; (2) compose and send an email, and (3) complete an on-line questionnaire while utilizing the pedal desk."
11162990|NCT01956071|OG000|Outcome|Pedal Desk Acceptability|"Orientation sessions will last approximately 30 minutes and will provide participants detailed information about the study, including the number and type of assessments, the length and nature of the pedal desk trial session, the time commitment required, and the potential risks and benefits of participation. Participants will be given a copy of the informed consent form to read and review. Interested participants will schedule their 30 minute trial visit.~At the trial visit, participants' questions will be answered and they will be asked to complete the informed consent form prior to beginning any study procedures. At this one and only visit height, weight, body fat percentage, and Bioelectrical Impedance Analysis will be measured. Participants will also be asked to complete 3 computer based tasks while using the pedal desk (1) search a topic on the internet; (2) compose and send an email, and (3) complete an on-line questionnaire while utilizing the pedal desk."
11162991|NCT01956071|EG000|Reported Event|Pedal Desk Acceptability|"Orientation sessions will last approximately 30 minutes and will provide participants detailed information about the study, including the number and type of assessments, the length and nature of the pedal desk trial session, the time commitment required, and the potential risks and benefits of participation. Participants will be given a copy of the informed consent form to read and review. Interested participants will schedule their 30 minute trial visit.~At the trial visit, participants' questions will be answered and they will be asked to complete the informed consent form prior to beginning any study procedures. At this one and only visit height, weight, body fat percentage, and Bioelectrical Impedance Analysis will be measured. Participants will also be asked to complete 3 computer based tasks while using the pedal desk (1) search a topic on the internet; (2) compose and send an email, and (3) complete an on-line questionnaire while utilizing the pedal desk."
11162992|NCT01956097|BG000|Baseline|HX106 590mg|"HX106 590mg/day~HX106 590mg"
11162993|NCT01956097|BG001|Baseline|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
11162994|NCT01956097|BG002|Baseline|Placebo|"Placebo~Placebo"
11162995|NCT01956097|BG003|Baseline|Total|Total of all reporting groups
11162996|NCT01956097|FG000|Participant Flow|HX106 590mg|"HX106 590mg/day~HX106 590mg"
11162997|NCT01956097|FG001|Participant Flow|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
11162998|NCT01956097|FG002|Participant Flow|Placebo|"Placebo~Placebo"
11162999|NCT01956097|OG000|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
11163000|NCT01956097|OG001|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
11163001|NCT01956097|OG002|Outcome|Placebo|"Placebo~Placebo"
11163002|NCT01956097|EG000|Reported Event|HX106 590mg|"HX106 590mg/day~HX106 590mg"
11163003|NCT01956097|EG001|Reported Event|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
11163004|NCT01956097|EG002|Reported Event|Placebo|"Placebo~Placebo"
11163005|NCT01956123|BG000|Baseline|FE 999049 (COS Cycle 2)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11228220|NCT02388815|FG000|Participant Flow|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11163006|NCT01956123|BG001|Baseline|GONAL-F (COS Cycle 2)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163007|NCT01956123|BG002|Baseline|Total|Total of all reporting groups
11163008|NCT01956123|FG000|Participant Flow|FE 999049 (COS Cycle 2)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163009|NCT01956123|FG001|Participant Flow|GONAL-F (COS Cycle 2)|Follitropin Alfa (GONAL-F) was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 international units (IU) based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163010|NCT01956123|FG002|Participant Flow|FE 999049 (COS Cycle 3)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163011|NCT01956123|FG003|Participant Flow|GONAL-F (COS Cycle 3)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163012|NCT01956123|OG000|Outcome|FE 999049 (COS Cycle 2)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163013|NCT01956123|OG001|Outcome|GONAL-F (COS Cycle 2)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163014|NCT01956123|OG002|Outcome|FE 999049 (COS Cycle 3)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163015|NCT01956123|OG003|Outcome|GONAL-F (COS Cycle 3)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163016|NCT01956123|OG001|Outcome|GONAL-F (COS Cycle 2)|Follitropin Alfa (GONAL-F) was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163017|NCT01956123|EG000|Reported Event|FE 999049 (COS Cycle 2)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163018|NCT01956123|EG001|Reported Event|GONAL-F (COS Cycle 2)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163019|NCT01956123|EG002|Reported Event|FE 999049 (COS Cycle 3)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11228221|NCT02388815|OG000|Outcome|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11163020|NCT01956123|EG003|Reported Event|GONAL-F (COS Cycle 3)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11163021|NCT01956240|BG000|Baseline|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
11163022|NCT01956240|BG001|Baseline|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
11163023|NCT01956240|BG002|Baseline|Total|Total of all reporting groups
11163024|NCT01956240|FG000|Participant Flow|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
11163025|NCT01956240|FG001|Participant Flow|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
11163026|NCT01956240|OG000|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
11163027|NCT01956240|OG001|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
11163028|NCT01956240|EG000|Reported Event|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
11163029|NCT01956240|EG001|Reported Event|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
11163030|NCT01956279|BG000|Baseline|Pregnenolone (Arm 1)|Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
11163031|NCT01956279|BG001|Baseline|Placebo (Arm 2)|Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
11163032|NCT01956279|BG002|Baseline|Total|Total of all reporting groups
11163033|NCT01956279|FG000|Participant Flow|Pregnenolone (Arm 1)|Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
11163034|NCT01956279|FG001|Participant Flow|Placebo (Arm 2)|Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
11163035|NCT01956279|OG000|Outcome|Pregnenolone (Arm 1)|Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
11163036|NCT01956279|OG001|Outcome|Placebo (Arm 2)|Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
11163037|NCT01956279|EG000|Reported Event|Pregnenolone (Arm 1)|Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
11163038|NCT01956279|EG001|Reported Event|Placebo (Arm 2)|Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
11163039|NCT01956435|BG000|Baseline|All Participants|All Study Participants
11163040|NCT01956435|FG000|Participant Flow|Excimer Light Treatment Right Leg, Control Left Leg|Excimer light treatment will be performed on patients randomized to receive treatment on the right leg and left leg will be untreated control
11163041|NCT01956435|FG001|Participant Flow|Excimer Light Treatment Left Leg, Control Right Leg|Excimer light treatment will be performed on patients randomized to receive treatment on the left leg and right leg will be untreated control
11163042|NCT01956435|OG000|Outcome|Excimer Light Treatment|Lesions treated with excimer light
11163043|NCT01956435|OG001|Outcome|Control|Lesions not treated with excimer light
11163044|NCT01956435|OG000|Outcome|All Patients|All study patients
11163045|NCT01956435|EG000|Reported Event|Excimer Light Treatment|Lesions treated with excimer light
11163046|NCT01956435|EG001|Reported Event|Control|Lesions not treated with excimer light
11163047|NCT01956773|BG000|Baseline|MeTree - Patients|"MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients as clinical decision support.~MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care"
11163048|NCT01956773|BG001|Baseline|MeTree - Providers|"MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to Providers as clinical decision support.~MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care"
11163049|NCT01956773|BG002|Baseline|Total|Total of all reporting groups
11163050|NCT01956773|FG000|Participant Flow|MeTree - Patients|"MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients and providers as clinical decision support.~MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care"
11163051|NCT01956773|FG001|Participant Flow|MeTree - Providers|Providers using MeTree risk assessment program for clinical decision support
11163052|NCT01956773|OG000|Outcome|MeTree - Patients|"MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients as clinical decision support.~MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care"
11163053|NCT01956773|OG000|Outcome|MeTree - Providers|"MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to providers as clinical decision support.~MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care"
11163054|NCT01956773|EG000|Reported Event|MeTree - Patients|"MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients as clinical decision support.~MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care"
11163055|NCT01956773|EG001|Reported Event|MeTree - Providers|"MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to providers as clinical decision support.~MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care"
11163056|NCT01957085|BG000|Baseline|Hospitalized Patients|"All patients admitted to Temple University Hospital on the study day~Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory"
11163057|NCT01957085|FG000|Participant Flow|Hospitalized Patients|"All patients admitted to Temple University Hospital on the study day~Observation only, no intervention: Hepatitis C antibody and RNA measured from leftover sera and plasma from the clinical laboratory"
11163058|NCT01957085|OG000|Outcome|Hospitalized Patients|"All patients admitted to Temple University Hospital on the study day~Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory"
11163059|NCT01957085|OG000|Outcome|Hospitalized Patients/Participants|"All patients admitted to Temple University Hospital on the study day~Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory"
11163060|NCT01957085|EG000|Reported Event|Hospitalized Patients|"All patients admitted to Temple University Hospital on the study day~Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory"
11163061|NCT01957111|BG000|Baseline|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
11163062|NCT01957111|BG001|Baseline|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
11163063|NCT01957111|BG002|Baseline|Total|Total of all reporting groups
11163064|NCT01957111|FG000|Participant Flow|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
11163065|NCT01957111|FG001|Participant Flow|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
11163066|NCT01957111|OG000|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
11163067|NCT01957111|OG001|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
11163068|NCT01957111|EG000|Reported Event|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
11163069|NCT01957111|EG001|Reported Event|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
11163070|NCT01957137|BG000|Baseline|Subjects Who First Finished Unique Randomization Sequences|Baseline descriptions provided were based on 24 subjects who first finished unique randomization sequences, which are those subjects included in the primary analysis of the primary outcome.
11163071|NCT01957137|FG000|Participant Flow|All Study Participants|Thirty subjects were randomized to 1 of 24 sequences with 4 cycling settings: 2 subjects discontinued early with 1 due to an AE, and 1 due to consent withdrawal. Twenty-eight subjects completed the randomization sequences . After that all subjects went through no stimulation for approximately 4 weeks, which was not part of randomization.
11163072|NCT01957137|OG000|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
11163073|NCT01957137|OG001|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
11163074|NCT01957137|OG002|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
11163075|NCT01957137|OG003|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
11163076|NCT01957137|OG000|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
11163077|NCT01957137|EG000|Reported Event|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
11163078|NCT01957137|EG001|Reported Event|Cycling Parameter #1|Subjects received Cycling Parameter #1 for approximately 4 weeks.
11163079|NCT01957137|EG002|Reported Event|Cycling Parameter #2|Subjects received Cycling Parameter #2 for approximately 4 weeks.
11163080|NCT01957137|EG003|Reported Event|Cycling Parameter #3|Subjects received Cycling Parameter #3 for approximately 4 weeks.
11163081|NCT01957137|EG004|Reported Event|No Stimulation|Subjects received no stimulation for approximately 4 weeks.
11163082|NCT01957150|BG000|Baseline|Participants Administered VI|Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.
11163083|NCT01957150|BG001|Baseline|Participants Administered FF/VI|Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.
11163084|NCT01957150|BG002|Baseline|Total|Total of all reporting groups
11163085|NCT01957150|FG000|Participant Flow|Participants Administered VI|Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.
11163086|NCT01957150|FG001|Participant Flow|Participants Administered FF/VI|Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.
11163087|NCT01957150|OG000|Outcome|Participants Administered VI|Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.
11163088|NCT01957150|OG001|Outcome|Participants Administered FF/VI|Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.
11163089|NCT01957150|EG000|Reported Event|Participants Administered VI|Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.
11163090|NCT01957150|EG001|Reported Event|Participants Administered FF/VI|Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.
11163091|NCT01957163|BG000|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163092|NCT01957163|BG001|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163093|NCT01957163|BG002|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163094|NCT01957163|BG003|Baseline|Total|Total of all reporting groups
11163095|NCT01957163|FG000|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163096|NCT01957163|FG001|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163097|NCT01957163|FG002|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163098|NCT01957163|OG000|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163099|NCT01957163|OG001|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163100|NCT01957163|OG002|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163101|NCT01957163|EG000|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163102|NCT01957163|EG001|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163103|NCT01957163|EG002|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11163104|NCT01957202|BG000|Baseline|FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, Levo 200 µg, FF 100 μg/Levo 200 μg and placebo once daily (OD) in the morning as 2 nasal sprays (FF: 25 µg per spray, Levo: 50 μg per spray, FF/Levo: 25 μg/50 μg per spray) into each nostril for 8 days each, in a crossover design. Treatment was given in one of 18 sequences in Periods 1, 2, and 3, (with a minimum of a 14-day washout period between treatments): BCD, BAC, BCA, DAC, DCB, CDB, ADC, CAD, DCA, ACB, BDC, CBA, CBD, ACD, CAB, CDA, ABC, DBC (A, FF 100 μg; B, Levo 200 μg; C, FF 100 μg/Levo 200 μg; D, placebo). On Day 1 and Day 8 of each treatment period, participants were subjected to an allergen challenge in a Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit of 14-28 days after their last dose, and the overall duration for participation in the study (screening to follow-up) was 20 weeks.
11163105|NCT01957202|FG000|Participant Flow|Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), fluticasone furoate (FF) 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg once daily (OD) in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163106|NCT01957202|FG001|Participant Flow|Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163107|NCT01957202|FG002|Participant Flow|Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163108|NCT01957202|FG003|Participant Flow|Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11228222|NCT02388815|EG000|Reported Event|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11163109|NCT01957202|FG004|Participant Flow|Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163110|NCT01957202|FG005|Participant Flow|Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163111|NCT01957202|FG006|Participant Flow|Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163112|NCT01957202|FG007|Participant Flow|Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163113|NCT01957202|FG008|Participant Flow|Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163114|NCT01957202|FG009|Participant Flow|Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163115|NCT01957202|FG010|Participant Flow|Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163116|NCT01957202|FG011|Participant Flow|Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163117|NCT01957202|FG012|Participant Flow|Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163118|NCT01957202|FG013|Participant Flow|Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163119|NCT01957202|FG014|Participant Flow|Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163120|NCT01957202|FG015|Participant Flow|Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, placeboμg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo µg OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163121|NCT01957202|FG016|Participant Flow|Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163122|NCT01957202|FG017|Participant Flow|Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
11163123|NCT01957202|OG000|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
11163124|NCT01957202|OG001|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
11163125|NCT01957202|OG002|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
11163126|NCT01957202|OG003|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
11163127|NCT01957202|EG000|Reported Event|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
11163128|NCT01957202|EG001|Reported Event|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
11163129|NCT01957202|EG002|Reported Event|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
11163130|NCT01957202|EG003|Reported Event|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
11163131|NCT01957215|BG000|Baseline|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
11163132|NCT01957215|BG001|Baseline|Placebo Patch|Placebo patch was applied on the sprained ankle BID
11163133|NCT01957215|BG002|Baseline|Total|Total of all reporting groups
11163134|NCT01957215|FG000|Participant Flow|Indomethacin Patch|0.35% w/w Indomethacin patch was applied on the sprained ankle twice a day (BID).
11163135|NCT01957215|FG001|Participant Flow|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
11163136|NCT01957215|OG000|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
11163137|NCT01957215|OG001|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
11163138|NCT01957215|OG000|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
11163139|NCT01957215|OG001|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
11163140|NCT01957215|OG000|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID.
11163141|NCT01957215|OG001|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
11163142|NCT01957215|EG000|Reported Event|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle twice a day (BID).
11163143|NCT01957215|EG001|Reported Event|Placebo Patch|Placebo patch to be applied on the sprained ankle BID.
11163144|NCT01957384|BG000|Baseline|All Subjects|
11163145|NCT01957384|FG000|Participant Flow|First Test Product 1, Then Test Product 2;Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 1 are randomised to secondly test :~- Coloplast Test product 2~and thereafter~- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2"
11163146|NCT01957384|FG001|Participant Flow|First Test Product 1, Then Standard Care, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 1 are randomised to secondly test :~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)~and thereafter~1) Coloplast Test product 2"
11163147|NCT01957384|FG002|Participant Flow|First Test Product 2, Then Test Product 1, Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 2 are randomised to secondly test~1) Coloplast Test product 1~and thereafter~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)"
11163148|NCT01957384|FG003|Participant Flow|First Test Product 2; Then Standard Care, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 2 are randomised to secondly test :~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)~and thereafter~1) Coloplast Test product 1"
11163149|NCT01957384|FG004|Participant Flow|First Standard Care, Then Test Product 1, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test~1) Coloplast Test product 1~and thereafter~1) Coloplast Test product 2"
11163150|NCT01957384|FG005|Participant Flow|First Standard Care, Then Test Product 2, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test~1) Coloplast Test product 2~and thereafter~1) Coloplast Test product 1"
11163151|NCT01957384|OG000|Outcome|Coloplast Test Product 1|leakage data from all Test 1 baseplates
11163152|NCT01957384|OG001|Outcome|Coloplast Test Product 2|Leakage data from all Test 2 baseplates
11163153|NCT01957384|OG002|Outcome|Standard Care|leakage data from all Standard Care baseplates
11163154|NCT01957384|EG000|Reported Event|Coloplast Test Product 1|data from all subjects who tested Test 1 baseplates
11163155|NCT01957384|EG001|Reported Event|Coloplast Test Product 2|data from all subjects who tested Test 2 baseplates
11163156|NCT01957384|EG002|Reported Event|Standard Care|data from all subjects who tested Standard Care baseplates
11163157|NCT01957397|BG000|Baseline|Overall Population|
11163158|NCT01957397|FG000|Participant Flow|1st Coloplast Test 1,2nd Coloplast Test 2 3rd Coloplast Test 3|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
11163159|NCT01957397|FG001|Participant Flow|1st Coloplast Test 2 2nd Coloplast Test 1 3rd Coloplast Test 3|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
11163160|NCT01957397|OG000|Outcome|Coloplast Test 1|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
11163161|NCT01957397|OG001|Outcome|Coloplast Test 2|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
11163162|NCT01957397|OG002|Outcome|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
11163163|NCT01957397|OG003|Outcome|Baseline - Own Product|The subjects test own product to measure their baseline leakage
11163164|NCT01957397|EG000|Reported Event|Coloplast Test 1|Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
11163165|NCT01957397|EG001|Reported Event|Coloplast Test 2|Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
11163166|NCT01957397|EG002|Reported Event|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
11163167|NCT01957397|EG003|Reported Event|Baseline - Own Product|The subjects test own product to measure their baseline leakage
11163168|NCT01957410|BG000|Baseline|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
11163169|NCT01957410|FG000|Participant Flow|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
11163170|NCT01957410|OG000|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
11163171|NCT01957410|EG000|Reported Event|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
11163172|NCT01957462|BG000|Baseline|All Subjects|
11163173|NCT01957462|FG000|Participant Flow|FirstColplast Test V, Then Coloplast Test X|"The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X~Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance~Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
11163174|NCT01957462|FG001|Participant Flow|First Coloplast Test X, Then Coloplast Test V|"The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V~Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance~Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
11163175|NCT01957462|OG000|Outcome|Test V|The results presented for the subjects testing Coloplast Test V
11163176|NCT01957462|OG001|Outcome|Test X|the results presented for the subjects testing Test X
11163177|NCT01957462|EG000|Reported Event|Test V|The results presented for the subjects testing Coloplast Test V
11163178|NCT01957462|EG001|Reported Event|Test X|the results presented for the subjects testing Test X
11228223|NCT02388880|BG000|Baseline|ITPR|"Use of the ITPR for 240 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
11228224|NCT02388880|FG000|Participant Flow|ITPR|"Use of the ITPR for 240 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
11163179|NCT01957475|BG000|Baseline|All Subjects|
11163180|NCT01957475|FG000|Participant Flow|First Coloplast Test Product Z; Then Coloplast Test Product Y|"The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y~Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance~Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
11163181|NCT01957475|FG001|Participant Flow|First Coloplast Test Product Y, Then Coloplast Test Product Z|"The subjects first test test product Y and after cross-over test product Z~Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance~Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
11163182|NCT01957475|OG000|Outcome|Test Y|Results from the subjects testing Coloplast Test Y
11163183|NCT01957475|OG001|Outcome|Test Z|Results from the subjects testing Coloplast Test Y
11163184|NCT01957475|EG000|Reported Event|Test Y|Results from the subjects testing Coloplast Test Y
11163185|NCT01957475|EG001|Reported Event|Test Z|Results from the subjects testing Coloplast Test Y
11163186|NCT01957488|BG000|Baseline|All Subjects|
11163187|NCT01957488|FG000|Participant Flow|SenSura/Test 1/Test 2|"The subjects in this group test the following in the order described below:~SenSura (the comparator)~Test 1~Test 2~The products are single use products which in average are removed and re-applyed every1-2nd day."
11163188|NCT01957488|FG001|Participant Flow|SenSura/Test 2/Test 1|"The subjects in this group test the following in the order described below:~SenSura (the comparator)~Test 2~Test 1~The products are single use products which in average are removed and re-applyed every1-2nd day."
11163189|NCT01957488|FG002|Participant Flow|Test 1/SenSura/Test 2|"The subjects in this group test the following in the order described below:~Test 1~SenSura (the comparator)~Test 2~The products are single use products which in average are removed and re-applyed every1-2nd day."
11163190|NCT01957488|FG003|Participant Flow|Test 1/Test 2/SenSura|"The subjects in this group test the following in the order described below:~Test 1~Test 2~SenSura (the comparator)~The products are single use products which in average are removed and re-applyed every1-2nd day."
11163191|NCT01957488|FG004|Participant Flow|Test 2/SenSura/Test 1|"The subjects in this group test the following in the order described below:~Test 2~SenSura (the comparator)~Test 1~The products are single use products which in average are removed and re-applyed every1-2nd day."
11163192|NCT01957488|FG005|Participant Flow|Test 2/Test 1/SenSura|"The subjects in this group test the following in the order described below:~Test 2~Test 1~SenSura (the comparator)~The products are single use products which in average are removed and re-applyed every1-2nd day."
11163193|NCT01957488|OG000|Outcome|Test 1|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 1
11163194|NCT01957488|OG001|Outcome|Test 2|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 2
11163195|NCT01957488|OG002|Outcome|SenSura|Fraction of baseplates with No leakage/Seeping under the baseplate for subjects testing SenSura
11163196|NCT01957488|EG000|Reported Event|Test 1|Subjects testing Coloplast Test 1
11163197|NCT01957488|EG001|Reported Event|Test 2|Subjects testing Coloplast Test 2
11163198|NCT01957488|EG002|Reported Event|SenSura|Subjects testing SenSura
11163199|NCT01957553|BG000|Baseline|All Subjects|baseline data are summarized for all subjects
11163200|NCT01957553|FG000|Participant Flow|Treatment Sequence 1, First Coloplast Test Product, the SenSur|"Subjects first allocated to Coloplast Test product will after cross-over test SenSura~Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance~SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
11163201|NCT01957553|FG001|Participant Flow|Treatment Seqence 2; First SenSura the Coloplast Test Product|"Subjects first allocated to SenSura will after cross-over test Coloplast Test product~Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance~SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
11163202|NCT01957553|OG000|Outcome|Coloplast Test Product|
11163203|NCT01957553|OG001|Outcome|SenSura|
11163204|NCT01957553|EG000|Reported Event|Test Product|Safety data for subjects exposed to the test product
11163205|NCT01957553|EG001|Reported Event|SenSura|Safety data for subjects exposed to SenSura
11163206|NCT01957579|BG000|Baseline|2 mg/kg|MEDI-551 2mg/kg
11163207|NCT01957579|BG001|Baseline|4 mg/kg|MEDI-551 4 mg/kg
11163208|NCT01957579|BG002|Baseline|8 mg/kg|MEDI-551 8 mg/kg
11163209|NCT01957579|BG003|Baseline|12 mg/kg|MEDI-551 12 mg/kg
11163210|NCT01957579|BG004|Baseline|Total|Total of all reporting groups
11163211|NCT01957579|FG000|Participant Flow|2 mg/kg|MEDI-551 2 mg/kg
11163212|NCT01957579|FG001|Participant Flow|4 mg/kg|MEDI-551 4 mg/kg
11163213|NCT01957579|FG002|Participant Flow|8 mg/kg|MEDI-551 8 mg/kg
11163214|NCT01957579|FG003|Participant Flow|12 mg/kg|MEDI-551 12 mg/kg
11163215|NCT01957579|OG000|Outcome|2 mg/kg|MEDI-551 2 mg/kg
11163216|NCT01957579|OG001|Outcome|4 mg/kg|MEDI-551 4 mg/kg
11163217|NCT01957579|OG002|Outcome|8 mg/kg|MEDI-551 8 mg/kg
11163218|NCT01957579|OG003|Outcome|12 mg/kg|MEDI-551 12 mg/kg
11163219|NCT01957579|OG000|Outcome|MEDI-551|MEDI-551 2, 4, 8 and 12 mg/kg were evaluated
11163220|NCT01957579|OG000|Outcome|2 mg/kg (FL)|FL patients in MEDI-551 2 mg/kg cohort
11163221|NCT01957579|OG001|Outcome|4 mg/kg (FL)|FL patients in MEDI-551 4 mg/kg cohort
11163222|NCT01957579|OG002|Outcome|8 mg/kg (FL)|FL patients in MEDI-551 8 mg/kg cohort
11163223|NCT01957579|OG003|Outcome|12 mg/kg (FL)|FL patients in MEDI-551 12 mg/kg cohort
11163224|NCT01957579|OG000|Outcome|2 mg/kg (DLBCL)|DLBCL patients in MEDI-551 2 mg/kg cohort
11163225|NCT01957579|OG001|Outcome|4 mg/kg (DLBCL)|DLBCL patients in MEDI-551 4 mg/kg cohort
11163226|NCT01957579|OG002|Outcome|8 mg/kg (DLBCL)|DLBCL patients in MEDI-551 8 mg/kg cohort
11163227|NCT01957579|OG003|Outcome|12 mg/kg (DLBCL)|DLBCL patients in MEDI-551 12 mg/kg cohort
11163228|NCT01957579|OG000|Outcome|2 mg/kg (CLL)|CLL patients in MEDI-551 2 mg/kg cohort
11163229|NCT01957579|OG001|Outcome|4 mg/kg (CLL)|CLL patients in MEDI-551 4 mg/kg cohort
11163230|NCT01957579|OG002|Outcome|8 mg/kg (CLL)|CLL patients in MEDI-551 8 mg/kg cohort
11163231|NCT01957579|OG003|Outcome|12 mg/kg (CLL)|CLL patients in MEDI-551 12 mg/kg cohort
11163232|NCT01957579|OG000|Outcome|2 mg/kg (MM)|MM patients in MEDI-551 2 mg/kg cohort
11163233|NCT01957579|OG001|Outcome|4 mg/kg (MM)|MM patients in MEDI-551 4 mg/kg cohort
11163234|NCT01957579|OG002|Outcome|8 mg/kg (MM)|MM patients in MEDI-551 8 mg/kg cohort
11163235|NCT01957579|OG003|Outcome|12 mg/kg (MM)|MM patients in MEDI-551 12 mg/kg cohort
11163236|NCT01957579|EG000|Reported Event|2 mg/kg|MEDI-551 2mg/kg
11163237|NCT01957579|EG001|Reported Event|4 mg/kg|MEDI-551 4 mg/kg
11163238|NCT01957579|EG002|Reported Event|8 mg/kg|MEDI-551 8 mg/kg
11163239|NCT01957579|EG003|Reported Event|12 mg/kg|MEDI-551 12 mg/kg
11163240|NCT01957644|BG000|Baseline|Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1|Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
11163241|NCT01957644|BG001|Baseline|Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1|Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163242|NCT01957644|BG002|Baseline|Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1|Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
11163243|NCT01957644|BG003|Baseline|Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163244|NCT01957644|BG004|Baseline|Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163245|NCT01957644|BG005|Baseline|Total|Total of all reporting groups
11163246|NCT01957644|FG000|Participant Flow|Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1|Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
11163247|NCT01957644|FG001|Participant Flow|Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1|Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163248|NCT01957644|FG002|Participant Flow|Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1|Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
11163249|NCT01957644|FG003|Participant Flow|Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163250|NCT01957644|FG004|Participant Flow|Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163251|NCT01957644|OG000|Outcome|Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1|Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
11163252|NCT01957644|OG001|Outcome|Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1|Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163253|NCT01957644|OG002|Outcome|Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163254|NCT01957644|OG003|Outcome|Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163255|NCT01957644|OG002|Outcome|Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1|Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
11163256|NCT01957644|OG003|Outcome|Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163257|NCT01957644|OG004|Outcome|Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163258|NCT01957644|EG000|Reported Event|Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1|Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
11163259|NCT01957644|EG001|Reported Event|Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1|Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163260|NCT01957644|EG002|Reported Event|Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1|Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
11163261|NCT01957644|EG003|Reported Event|Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163262|NCT01957644|EG004|Reported Event|Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2|Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
11163263|NCT01957657|BG000|Baseline|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
11163264|NCT01957657|FG000|Participant Flow|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir, immediate release tablet, plus faldaprevir, soft gelatin capsule, were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir, qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
11163265|NCT01957657|OG000|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
11163266|NCT01957657|EG000|Reported Event|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
11163267|NCT01957709|BG000|Baseline|Basic Science (Interferon Gamma and MHC Expression)|"Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.~Laboratory Biomarker Analysis: Correlative studies~Recombinant Interferon Gamma: Given SC"
11163268|NCT01957709|FG000|Participant Flow|Basic Science (Interferon Gamma and MHC Expression)|"Patients receive recombinant interferon gamma SC weekly for 4 weeks before surgery.~Laboratory Biomarker Analysis: Correlative studies~Recombinant Interferon Gamma: Given Subcutaneously"
11163269|NCT01957709|OG000|Outcome|Basic Science (Interferon Gamma and MHC Expression)|"Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.~Laboratory Biomarker Analysis: Correlative studies~Recombinant Interferon Gamma: Given SC"
11163270|NCT01957709|EG000|Reported Event|Basic Science (Interferon Gamma and MHC Expression)|"Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.~Laboratory Biomarker Analysis: Correlative studies~Recombinant Interferon Gamma: Given SC"
11163271|NCT01957761|BG000|Baseline|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
11163272|NCT01957761|FG000|Participant Flow|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
11163273|NCT01957761|OG000|Outcome|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
11163274|NCT01957761|EG000|Reported Event|Clostridium Difficile Infection|
11228225|NCT02388880|OG000|Outcome|ITPR|"Use of the ITPR for 240 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
11163275|NCT01957787|BG000|Baseline|Cryoablation|Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
11163276|NCT01957787|FG000|Participant Flow|Cryoablation|Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
11163277|NCT01957787|OG000|Outcome|Cryoablation|Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
11163278|NCT01957787|EG000|Reported Event|Cryoablation|Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
11163279|NCT01957865|BG000|Baseline|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
11163280|NCT01957865|BG001|Baseline|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
11163281|NCT01957865|BG002|Baseline|Control|Real-time adherence monitoring only (no SMS)
11163282|NCT01957865|BG003|Baseline|Total|Total of all reporting groups
11163283|NCT01957865|FG000|Participant Flow|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
11163284|NCT01957865|FG001|Participant Flow|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
11163285|NCT01957865|FG002|Participant Flow|Control|Real-time adherence monitoring only (no SMS)
11163286|NCT01957865|OG000|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
11163287|NCT01957865|OG001|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
11163288|NCT01957865|OG002|Outcome|Control|Real-time adherence monitoring only (no SMS)
11163289|NCT01957865|OG001|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence"
11163290|NCT01957865|EG000|Reported Event|Fixed SMS, Real-time Monitoring|"SMS were sent daily for one month, then weekly for two months. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
11163291|NCT01957865|EG001|Reported Event|Triggered SMS, Real-time Monitoring|"Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
11163292|NCT01957865|EG002|Reported Event|Control|Real-time adherence monitoring only (no SMS)
11163293|NCT01957930|BG000|Baseline|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
11163294|NCT01957930|BG001|Baseline|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
11163295|NCT01957930|BG002|Baseline|Healthy Control|Solely controls for the iontophoresis method and no intention to be followd-up.
11163296|NCT01957930|BG003|Baseline|Total|Total of all reporting groups
11163297|NCT01957930|FG000|Participant Flow|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
11163298|NCT01957930|FG001|Participant Flow|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
11163299|NCT01957930|FG002|Participant Flow|Healthy Controls|19 healthy controls were invited to compare microcirculation between healthy and diabetes individuals
11163300|NCT01957930|OG000|Outcome|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
11163301|NCT01957930|OG001|Outcome|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
11163302|NCT01957930|EG000|Reported Event|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
11163303|NCT01957930|EG001|Reported Event|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
11163304|NCT01957930|EG002|Reported Event|Healthy Controls|These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up.
11163305|NCT01958008|BG000|Baseline|Placebo|Oral administration of Placebo matching BI 113608
11163306|NCT01958008|BG001|Baseline|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
11163307|NCT01958008|BG002|Baseline|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
11163308|NCT01958008|BG003|Baseline|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
11163309|NCT01958008|BG004|Baseline|Total|Total of all reporting groups
11163310|NCT01958008|FG000|Participant Flow|Placebo|Oral administration of Placebo matching BI 113608
11163311|NCT01958008|FG001|Participant Flow|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
11163312|NCT01958008|FG002|Participant Flow|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
11163313|NCT01958008|FG003|Participant Flow|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
11163314|NCT01958008|OG000|Outcome|Placebo|Oral administration of Placebo matching BI 113608
11163315|NCT01958008|OG001|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
11163316|NCT01958008|OG002|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
11163317|NCT01958008|OG003|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
11163318|NCT01958008|OG000|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
11163319|NCT01958008|OG001|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
11163320|NCT01958008|OG002|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
11163321|NCT01958008|EG000|Reported Event|Placebo|Oral administration of Placebo matching BI 113608
11163322|NCT01958008|EG001|Reported Event|10 mg Bid|Oral administration of BI 113608 10 mg film coated tablets twice daily
11163323|NCT01958008|EG002|Reported Event|25 mg Bid|Oral administration of BI 113608 25 mg film coated tablets twice daily
11163324|NCT01958008|EG003|Reported Event|50 mg Bid|Oral administration of BI 113608 50 mg film coated tablets twice daily
11163325|NCT01958060|BG000|Baseline|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
11163326|NCT01958060|BG001|Baseline|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163327|NCT01958060|BG002|Baseline|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163328|NCT01958060|BG003|Baseline|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163329|NCT01958060|BG004|Baseline|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163330|NCT01958060|BG005|Baseline|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163331|NCT01958060|BG006|Baseline|Total|Total of all reporting groups
11163332|NCT01958060|FG000|Participant Flow|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
11163333|NCT01958060|FG001|Participant Flow|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163334|NCT01958060|FG002|Participant Flow|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163335|NCT01958060|FG003|Participant Flow|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163336|NCT01958060|FG004|Participant Flow|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163337|NCT01958060|FG005|Participant Flow|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163338|NCT01958060|OG000|Outcome|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
11163339|NCT01958060|OG001|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163340|NCT01958060|OG002|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163341|NCT01958060|OG003|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163342|NCT01958060|OG004|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163343|NCT01958060|OG005|Outcome|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163344|NCT01958060|OG000|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163345|NCT01958060|OG001|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163346|NCT01958060|OG002|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163347|NCT01958060|OG003|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163348|NCT01958060|OG000|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163349|NCT01958060|EG000|Reported Event|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
11163350|NCT01958060|EG001|Reported Event|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163351|NCT01958060|EG002|Reported Event|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163352|NCT01958060|EG003|Reported Event|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163353|NCT01958060|EG004|Reported Event|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163354|NCT01958060|EG005|Reported Event|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
11163355|NCT01958073|BG000|Baseline|Placebo|"Per vagina 0.5g 2 times weekly~Placebo"
11163356|NCT01958073|BG001|Baseline|Vaginal Estrogen|"Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly~OR~Estradiol Ring per vagina every 3 months"
11163357|NCT01958073|BG002|Baseline|Total|Total of all reporting groups
11163358|NCT01958073|FG000|Participant Flow|Conjugated Estrogen Vaginal Cream|"Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly~Conjugated Estrogen Vaginal Cream"
11163359|NCT01958073|FG001|Participant Flow|Estradiol Ring|"Estradiol Ring per vagina every 3 months~Estradiol Ring"
11163360|NCT01958073|FG002|Participant Flow|Placebo|"Per vagina 0.5g 2 times weekly~Placebo"
11163361|NCT01958073|FG003|Participant Flow|Vaginal Cream Open Label|"Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly~Conjugated Estrogen Vaginal Cream"
11163362|NCT01958073|FG004|Participant Flow|Estradiol Ring Open Label|"Estradiol Ring per vagina every 3 months~Estradiol Ring"
11163363|NCT01958073|OG000|Outcome|Vaginal Estrogen|"Conjugated Estrogen Vaginal Cream~OR~Estradiol Ring"
11163364|NCT01958073|OG001|Outcome|Placebo|"Per vagina~Placebo"
11163365|NCT01958073|OG000|Outcome|Placebo During Randomization|"Per vagina 0.5g 2 times weekly~Placebo"
11163366|NCT01958073|OG001|Outcome|Vaginal Estrogen|"Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly~OR~Estradiol Ring per vagina every 3 months"
11163367|NCT01958073|OG002|Outcome|Initial Placebo to Open Label Vaginal Estrogen|Those participants initially randomized to placebo, during the period when they went on open label vaginal estrogen.
11163368|NCT01958073|OG000|Outcome|Placebo|"Per vagina 0.5g 2 times weekly~Placebo"
11163369|NCT01958073|OG000|Outcome|Conjugated Estrogen Vaginal Cream|"Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly~Conjugated Estrogen Vaginal Cream"
11163370|NCT01958073|OG001|Outcome|Estradiol Ring|"Estradiol Ring per vagina every 3 months~Estradiol Ring"
11163371|NCT01958073|OG002|Outcome|Placebo|"Per vagina~Placebo"
11163372|NCT01958073|EG000|Reported Event|Placebo|"Per vagina 0.5g 2 times weekly~Placebo"
11163373|NCT01958073|EG001|Reported Event|Vaginal Estrogen Cream Randomization|Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly
11163374|NCT01958073|EG002|Reported Event|Vaginal Estrogen Ring Randomization|Estradiol Ring per vagina every 3 months
11163375|NCT01958073|EG003|Reported Event|Vaginal Estrogen Cream Open Label|Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly
11163376|NCT01958073|EG004|Reported Event|Vaginal Estrogen Ring Open Label|Estradiol Ring per vagina every 3 months
11163377|NCT01958112|BG000|Baseline|GSK1120212 (Trametinib) and GSK2141795|"GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles~GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day~GSK2141795: The dose of GSK2141795 is 50 mg orally once per day"
11163378|NCT01958112|FG000|Participant Flow|GSK1120212 (Trametinib) and GSK2141795|"GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles~GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day~GSK2141795: The dose of GSK2141795 is 50 mg orally once per day"
11163379|NCT01958112|OG000|Outcome|GSK1120212 (Trametinib) and GSK2141795|"GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles~GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day~GSK2141795: The dose of GSK2141795 is 50 mg orally once per day"
11163380|NCT01958112|EG000|Reported Event|GSK1120212 (Trametinib) and GSK2141795|"GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles~GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day~GSK2141795: The dose of GSK2141795 is 50 mg orally once per day"
11163381|NCT01958125|BG000|Baseline|gammaCore|Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
11163382|NCT01958125|BG001|Baseline|Sham Device|Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
11163383|NCT01958125|BG002|Baseline|Total|Total of all reporting groups
11163384|NCT01958125|FG000|Participant Flow|gammaCore|Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
11163385|NCT01958125|FG001|Participant Flow|Sham Device|Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
11163386|NCT01958125|OG000|Outcome|gammaCore|Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
11163387|NCT01958125|OG001|Outcome|Sham Device|Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
11163388|NCT01958125|EG000|Reported Event|gammaCore|Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
11163389|NCT01958125|EG001|Reported Event|Sham Device|Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
11163390|NCT01958164|BG000|Baseline|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
11163391|NCT01958164|BG001|Baseline|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
11163392|NCT01958164|BG002|Baseline|Total|Total of all reporting groups
11163393|NCT01958164|FG000|Participant Flow|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
11163394|NCT01958164|FG001|Participant Flow|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
11163395|NCT01958164|OG000|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
11163396|NCT01958164|OG001|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
11163397|NCT01958164|EG000|Reported Event|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
11163398|NCT01958164|EG001|Reported Event|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
11163399|NCT01958281|BG000|Baseline|SOF 200 mg + RBV 200 mg (Cohort 1)|SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks
11163400|NCT01958281|BG001|Baseline|SOF 400 mg + RBV 200 mg (Cohort 2)|SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks
11163401|NCT01958281|BG002|Baseline|LDV/SOF (Cohort 3)|LDV/SOF 90/400 mg FDC tablet for 12 weeks
11163402|NCT01958281|BG003|Baseline|Total|Total of all reporting groups
11163403|NCT01958281|FG000|Participant Flow|SOF 200 mg + RBV 200 mg (Cohort 1)|Sofosbuvir (SOF) 200 mg tablet once daily + ribavirin (RBV) 200 mg tablet once daily for 24 weeks
11163404|NCT01958281|FG001|Participant Flow|SOF 400 mg + RBV 200 mg (Cohort 2)|SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks
11163405|NCT01958281|FG002|Participant Flow|LDV/SOF (Cohort 3)|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet for 12 weeks
11163406|NCT01958281|OG000|Outcome|SOF 200 mg + RBV 200 mg (Cohort 1)|SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks
11163407|NCT01958281|OG001|Outcome|SOF 400 mg + RBV 200 mg (Cohort 2)|SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks
11163408|NCT01958281|OG002|Outcome|LDV/SOF (Cohort 3)|LDV/SOF 90/400 mg FDC tablet for 12 weeks
11163409|NCT01958281|OG000|Outcome|LDV/SOF (Cohort 3)|LDV/SOF 90/400 mg FDC tablet for 12 weeks
11163410|NCT01958281|EG000|Reported Event|SOF 200 mg + RBV 200 mg (Cohort 1)|SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks
11163411|NCT01958281|EG001|Reported Event|SOF 400 mg + RBV 200 mg (Cohort 2)|SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks
11163412|NCT01958281|EG002|Reported Event|LDV/SOF (Cohort 3)|LDV/SOF 90/400 mg FDC tablet for 12 weeks
11163413|NCT01958294|BG000|Baseline|MICHI Neuroprotection System|"Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.~MICHI Neuroprotection System"
11228226|NCT02388880|EG000|Reported Event|ITPR|"Use of the ITPR for 240 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
11163414|NCT01958294|FG000|Participant Flow|MICHI Neuroprotection System|"Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.~MICHI Neuroprotection System The MICHI Neuroprotection System (MICHI NPS) is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.~The system permits transcervical access to the carotid lesion, and the flow reversal through the circuit re-directs emboli that are liberated during carotid angioplasty and stent delivery."
11163415|NCT01958294|OG000|Outcome|MICHI Neuroprotection System|"Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.~MICHI Neuroprotection System"
11163416|NCT01958294|EG000|Reported Event|MICHI Neuroprotection System|"Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.~MICHI Neuroprotection System"
11163417|NCT01958320|BG000|Baseline|Early Treatment|"Infants randomized to the early treatment group will receive pharmacologic treatment of the PDA to produce PDA closure. Within 24-36 hr following the last treatment dose an echocardiogram will be obtained to document the degree of ductus closure or patency.~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~pharmacologic treatment of the PDA: Following randomization, infants will be treated with medications used to produce PDA closure."
11163418|NCT01958320|BG001|Baseline|Conservative Treatment|"Infants randomized to the Conservative Treatment approach will receive no pharmacologic treatment of the PDA but will be followed to determine if they meet criteria for later PDA rescue treatment (Infants will be eligible for rescue treatment of their persistent PDA if they meet the rescue treatment criteria.)~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~no pharmacologic treatment of the PDA: Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time)."
11163419|NCT01958320|BG002|Baseline|Total|Total of all reporting groups
11163420|NCT01958320|FG000|Participant Flow|Early Treatment|"Infants randomized to the early treatment group will receive pharmacologic treatment of the PDA to produce PDA closure. Within 24-36 hr following the last treatment dose an echocardiogram will be obtained to document the degree of ductus closure or patency.~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~pharmacologic treatment of the PDA: Following randomization, infants will be treated with medications used to produce PDA closure."
11163421|NCT01958320|FG001|Participant Flow|Conservative Treatment|"Infants randomized to the Conservative Treatment approach will receive no pharmacologic treatment of the PDA but will be followed to determine if they meet criteria for later PDA rescue treatment (Infants will be eligible for rescue treatment of their persistent PDA if they meet the rescue treatment criteria.)~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~no pharmacologic treatment of the PDA: Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time)."
11163422|NCT01958320|OG000|Outcome|Early Treatment|"Infants randomized to the early treatment group will receive pharmacologic treatment of the PDA to produce PDA closure.~pharmacologic treatment of the PDA: Following randomization, infants will be treated with medications used to produce PDA closure."
11163423|NCT01958320|OG001|Outcome|Conservative Treatment|"Infants randomized to the Conservative Treatment approach will receive no pharmacologic treatment of the PDA but will be followed to determine if they meet criteria for later PDA rescue treatment (Infants will be eligible for rescue treatment of their persistent PDA if they meet the rescue treatment criteria.)~no pharmacologic treatment of the PDA: Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time)."
11163424|NCT01958320|OG000|Outcome|Early Treatment|"Infants randomized to the early treatment group will receive pharmacologic treatment of the PDA to produce PDA closure. Within 24-36 hr following the last treatment dose an echocardiogram will be obtained to document the degree of ductus closure or patency.~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~pharmacologic treatment of the PDA: Following randomization, infants will be treated with medications used to produce PDA closure."
11233890|NCT02431468|BG000|Baseline|Bryostatin 1 20ug|"Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11163425|NCT01958320|OG001|Outcome|Conservative Treatment|"Infants randomized to the Conservative Treatment approach will receive no pharmacologic treatment of the PDA but will be followed to determine if they meet criteria for later PDA rescue treatment (Infants will be eligible for rescue treatment of their persistent PDA if they meet the rescue treatment criteria.)~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~no pharmacologic treatment of the PDA: Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time)."
11163426|NCT01958320|EG000|Reported Event|Early Treatment|"Infants randomized to the early treatment group will receive pharmacologic treatment of the PDA to produce PDA closure. Within 24-36 hr following the last treatment dose an echocardiogram will be obtained to document the degree of ductus closure or patency.~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~pharmacologic treatment of the PDA: Following randomization, infants will be treated with medications used to produce PDA closure."
11163427|NCT01958320|EG001|Reported Event|Conservative Treatment|"Infants randomized to the Conservative Treatment approach will receive no pharmacologic treatment of the PDA but will be followed to determine if they meet criteria for later PDA rescue treatment (Infants will be eligible for rescue treatment of their persistent PDA if they meet the rescue treatment criteria.)~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~no pharmacologic treatment of the PDA: Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time)."
11163428|NCT01958346|BG000|Baseline|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
11163429|NCT01958346|BG001|Baseline|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
11163430|NCT01958346|BG002|Baseline|Total|Total of all reporting groups
11163431|NCT01958346|FG000|Participant Flow|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
11163432|NCT01958346|FG001|Participant Flow|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
11163433|NCT01958346|OG000|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
11163434|NCT01958346|OG001|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
11163435|NCT01958346|EG000|Reported Event|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
11163436|NCT01958346|EG001|Reported Event|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
11163437|NCT01958437|BG000|Baseline|Cognitively Intact Older Adults|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163438|NCT01958437|BG001|Baseline|Patients With Mild Cognitive Impairment|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163439|NCT01958437|BG002|Baseline|Total|Total of all reporting groups
11163440|NCT01958437|FG000|Participant Flow|Cognitively Intact -Active Then Sham tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163441|NCT01958437|FG001|Participant Flow|Cognitively Intact - Sham Then Active|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163442|NCT01958437|FG002|Participant Flow|MCI - Active Then Sham|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163443|NCT01958437|FG003|Participant Flow|MCI - Sham Then Active|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163444|NCT01958437|OG000|Outcome|Cognitively Intact ACTIVE tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163445|NCT01958437|OG001|Outcome|MCI ACTIVE tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163446|NCT01958437|OG002|Outcome|Cognitively Intact SHAM tDCS|all participants received sham in a randomized order
11163447|NCT01958437|OG003|Outcome|MCI SHAM tDCS|all participants received sham in a randomized order
11163448|NCT01958437|OG000|Outcome|MCI ACTIVE tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163449|NCT01958437|OG001|Outcome|MCI Sham HD-tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163450|NCT01958437|OG002|Outcome|Cognitively Intact ACTIVE HD-tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163451|NCT01958437|OG003|Outcome|Cognitively Intact Sham HD-tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163452|NCT01958437|OG001|Outcome|MCI ACTIVE HD-tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163453|NCT01958437|OG002|Outcome|Cognitively Intact SHAM HD-tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163454|NCT01958437|OG003|Outcome|MCI SHAM HD-tDCS|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163455|NCT01958437|EG000|Reported Event|Cognitively Intact Active|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163456|NCT01958437|EG001|Reported Event|Cognitively Intact Sham|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163457|NCT01958437|EG002|Reported Event|MCI Active|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163458|NCT01958437|EG003|Reported Event|MCI Sham|All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
11163459|NCT01958476|BG000|Baseline|Randomized: Methadone|"First line therapy: 0.4mg/mL oral solution, based on weight and symptoms.~Clinical monitoring: Infants scored using standardized Finnegan system;~Regimen: Initiated treatment w/ 2 consec. scores ≥8, or 1 score ≥12. Starting doses range 0.3mg/kg/day - 0.9mg/kg/day, divided every 8hrs depending on the severity of Finnegan scores. Doses were increased to max of 0.9mg/kg/day for contd. scores generally >8 caused primarily by worsening NAS, as needed. Weaned by 10% of max dose every 24-48 hours; Medication discontinued once at 25% of max dose.~Second Line Therapy: Phenobarbital (20mg/kg) was added once infant reached max methadone doses for contd. scores generally >8. Option to re-load w/ 10mg/kg q8-12 hours for 2 more doses if needed for contd. high scores. Maintenance therapy of 5mg/kg/day was initiated 12 - 24hrs after last loading dose. Phenobarbital trough levels monitored, w/ goal levels 20 - 30 mcg/mL. Weaning procedure outlined in protocol."
11163460|NCT01958476|BG001|Baseline|Randomized: Neonatal Morphine Solution|"First line therapy: 0.2mg/mL solution, based on weight and symptoms.~Clinical monitoring: Infants scored using standardized Finnegan system;~Regimen: Initiated treatment w/ 2 consec. scores ≥8, or 1 score ≥12. Starting doses range 0.3mg/kg/day - 0.9mg/kg/day, divided every 4hrs depending on the severity of Finnegan scores. Doses were increased to max of 0.9mg/kg/day for contd. scores generally >8 caused primarily by worsening NAS, as needed. Weaned by 10% of max dose every 24 - 48 hours; Medication discontinued once at 25% of max dose.~Second Line Therapy: Phenobarbital (20mg/kg) was added once infant reached max morphine doses for contd. scores generally >8. Option to re-load w/ 10mg/kg q8-12 hours for 2 more doses if needed for contd. high scores. Maintenance therapy of 5mg/kg/day was initiated 12 - 24hrs after last loading dose. Phenobarbital trough levels monitored, w/ goal levels 20 - 30 mcg/mL. Weaning procedure outlined in protocol."
11163461|NCT01958476|BG002|Baseline|Total|Total of all reporting groups
11163462|NCT01958476|FG000|Participant Flow|Methadone|"First line therapy: 0.4mg/mL oral solution, based on weight and symptoms.~Clinical monitoring: Infants scored using standardized Finnegan system;~Regimen: Initiated treatment w/ 2 consec. scores ≥8, or 1 score ≥12. Starting doses range 0.3mg/kg/day - 0.9mg/kg/day, divided every 8hrs depending on the severity of Finnegan scores. Doses were increased to max of 0.9mg/kg/day for contd. scores generally >8 caused primarily by worsening NAS, as needed. Weaned by 10% of max dose every 24-48 hours; Medication discontinued once at 25% of max dose.~Second Line Therapy: Phenobarbital (20mg/kg) was added once infant reached max methadone doses for contd. scores generally >8. Option to re-load w/ 10mg/kg q8-12 hours for 2 more doses if needed for contd. high scores. Maintenance therapy of 5mg/kg/day was initiated 12 - 24hrs after last loading dose. Phenobarbital trough levels monitored, w/ goal levels 20 - 30 mcg/mL. Weaning procedure outlined in protocol."
11163463|NCT01958476|FG001|Participant Flow|Neonatal Morphine Solution|"First line therapy: 0.2mg/mL solution, based on weight and symptoms.~Clinical monitoring: Infants scored using standardized Finnegan system;~Regimen: Initiated treatment w/ 2 consec. scores ≥8, or 1 score ≥12. Starting doses range 0.3mg/kg/day - 0.9mg/kg/day, divided every 4hrs depending on the severity of Finnegan scores. Doses were increased to max of 0.9mg/kg/day for contd. scores generally >8 caused primarily by worsening NAS, as needed. Weaned by 10% of max dose every 24 - 48 hours; Medication discontinued once at 25% of max dose.~Second Line Therapy: Phenobarbital (20mg/kg) was added once infant reached max morphine doses for contd. scores generally >8. Option to re-load w/ 10mg/kg q8-12 hours for 2 more doses if needed for contd. high scores. Maintenance therapy of 5mg/kg/day was initiated 12 - 24hrs after last loading dose. Phenobarbital trough levels monitored, w/ goal levels 20 - 30 mcg/mL. Weaning procedure outlined in protocol."
11163464|NCT01958476|OG000|Outcome|Methadone|"Infants randomized to this group will receive methadone oral solution (0.4mg/mL) for first line therapy. Infants will be scored using the standardized Finnegan scoring system and will be initiated on treatment if they have 2 consecutive scores greater than or equal to 8 or 1 score greater than or equal to 12. Dosing will be weight and symptom based. Starting doses will range from 0.3mg/kg/day to 0.9mg/kg/day divided every 8 hours depending on the severity of the Finnegan scores. To maintain blinding of the two study arms, a double dummy design will be used - each infant will receive both methadone/placebo study drug at 0.4 mg/mL and a morphine/placebo study drug at 0.2 mg/mL. Doses will be increased to a maximum of 0.9mg/kg/day for continued scores generally >8 caused primarily by worsening NAS as needed. Infants will be weaned by 10% of the maximum dose once every 24-48 hours and the medication will be discontinued once at 25% of the maximum dose."
11163465|NCT01958476|OG001|Outcome|Neonatal Morphine Solution|"Infants randomized to this arm will receive neonatal morphine solution (0.2mg/mL) for first line therapy. Infants will be scored using the standardized Finnegan scoring system and will be initiated on treatment if they have 2 consecutive scores greater than or equal to 8 or 1 score greater than or equal to 12. Dosing will be weight and symptom based. A double dummy design will be used - each infant will be ordered for both a methadone/placebo study drug at 0.4 mg/mL and a morphine/placebo study drug at 0.2 mg/mL. Starting doses will range from 0.3mg/kg/day to 0.9mg/kg/day divided every 4 hours depending on the severity of the Finnegan scores. Doses will be increased to a maximum of 0.9mg/kg/day for continued scores generally >8 caused primarily by worsening NAS. Infants will be weaned by 10% of the maximum dose once every 24 - 48 hours and the medication will be discontinued once at 25% of the maximum dose."
11163466|NCT01958476|EG000|Reported Event|Methadone|"Methadone oral solution (0.4mg/mL) for first line therapy. Infants were scored using the standardized Finnegan Scoring Tool and were initiated on treatment with 2 consecutive scores ≥8 or 1 score ≥12. Dosing was weight and symptom based. Starting doses range from 0.3mg/kg/day - 0.9mg/kg/day divided every 8 hours, depending on the severity of the Finnegan scores. To maintain blinding, a double dummy design was used - each infant received both methadone/placebo study drug at 0.4 mg/mL and a morphine/placebo study drug at 0.2 mg/mL. Doses were increased to a maximum of 0.9mg/kg/day for continued scores generally >8 caused primarily by worsening NAS, as needed. Infants were weaned by 10% of the maximum dose every 24-48 hours and the medication was discontinued once at 25% of the maximum dose."
11163467|NCT01958476|EG001|Reported Event|Neonatal Morphine Solution|"Neonatal morphine solution (0.2mg/mL) for first line therapy. Infants were scored using the standardized Finnegan Scoring Tool and were initiated on treatment with 2 consecutive scores ≥8 or 1 score ≥12. Dosing was weight and symptom based. Starting doses range from 0.3mg/kg/day - 0.9mg/kg/day divided every 4 hrs, depending on the severity of the Finnegan scores. To maintain blinding, a double dummy design was used - each infant received both methadone/placebo study drug at 0.4 mg/mL and a morphine/placebo study drug at 0.2 mg/mL. Doses were increased to a maximum of 0.9mg/kg/day for continued scores generally >8 caused primarily by worsening NAS, as needed. Infants were weaned by 10% of the maximum dose every 24-48 hours and the medication was discontinued once at 25% of the maximum dose."
11163468|NCT01958489|BG000|Baseline|Pravastatin and Evacetrapib + Pravastatin|40 mg oral dose of pravastatin was administered on Day 1. One hundred and thirty (130) mg oral dose of evacetrapib was administered QD on Days 2 through 11 and 40 mg oral dose of pravastatin was co-administered on Day 11.
11163469|NCT01958489|FG000|Participant Flow|Pravastatin|40 mg oral dose of pravastatin was administered on Day 1.
11163470|NCT01958489|FG001|Participant Flow|Evacetrapib + Pravastatin|130 mg oral dose of evacetrapib was administered once daily (QD) on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
11163471|NCT01958489|OG000|Outcome|Pravastatin (Period 1)|40 mg oral dose of pravastatin was administered on Day 1.
11163472|NCT01958489|OG001|Outcome|Evacetrapib + Pravastatin (Period 2)|130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
11163473|NCT01958489|OG001|Outcome|Evacetrapib + Pravastatin (Period 2)|130 mg oral dose of evacetrapib was administered QD on Days 2 through11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
11163474|NCT01958489|EG000|Reported Event|40 mg Pravastatin Japanese|40 mg oral dose of pravastatin was administered on Day 1.
11163475|NCT01958489|EG001|Reported Event|130 mg Evacetrapib Japanese|130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
11163476|NCT01958489|EG002|Reported Event|40 mg Pravastatin + 130 mg Evacetrapib Japanese|40 mg oral dose of pravastatin was administered on Day 1. 130 mg oral dose of evacetrapib was administered QD on Days 2 through11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
11163477|NCT01958489|EG003|Reported Event|40 mg Pravastatin Non-Japanese|40 mg oral dose of pravastatin was administered on Day 1.
11163478|NCT01958489|EG004|Reported Event|130 mg Evacetrapib Non-Japanese|130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
11163479|NCT01958489|EG005|Reported Event|40 mg Pravastatin + 130-mg Evacetrapib Non-Japanese|40 mg oral dose of pravastatin was administered on Day 1. 130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
11163480|NCT01958606|BG000|Baseline|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
11163481|NCT01958606|BG001|Baseline|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
11163482|NCT01958606|BG002|Baseline|Total|Total of all reporting groups
11163483|NCT01958606|FG000|Participant Flow|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
11163484|NCT01958606|FG001|Participant Flow|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
11163485|NCT01958606|OG000|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
11163486|NCT01958606|OG001|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
11163487|NCT01958606|EG000|Reported Event|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
11163488|NCT01958606|EG001|Reported Event|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
11163489|NCT01958619|BG000|Baseline|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163490|NCT01958619|BG001|Baseline|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163491|NCT01958619|BG002|Baseline|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163492|NCT01958619|BG003|Baseline|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163493|NCT01958619|BG004|Baseline|Total|Total of all reporting groups
11163494|NCT01958619|FG000|Participant Flow|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163495|NCT01958619|FG001|Participant Flow|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163496|NCT01958619|FG002|Participant Flow|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163497|NCT01958619|FG003|Participant Flow|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163498|NCT01958619|OG000|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163499|NCT01958619|OG001|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163500|NCT01958619|OG002|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163501|NCT01958619|OG003|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163502|NCT01958619|EG000|Reported Event|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163503|NCT01958619|EG001|Reported Event|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163504|NCT01958619|EG002|Reported Event|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163505|NCT01958619|EG003|Reported Event|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
11163506|NCT01958645|BG000|Baseline|Placebo|Placebo (Saline solution for infusion)
11163507|NCT01958645|BG001|Baseline|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
11163508|NCT01958645|BG002|Baseline|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
11163509|NCT01958645|BG003|Baseline|Total|Total of all reporting groups
11163510|NCT01958645|FG000|Participant Flow|Placebo|Placebo (Saline solution for infusion)
11163511|NCT01958645|FG001|Participant Flow|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
11163512|NCT01958645|FG002|Participant Flow|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
11163513|NCT01958645|OG000|Outcome|Placebo|Placebo (Saline solution for infusion)
11163514|NCT01958645|OG001|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
11163515|NCT01958645|OG002|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
11163516|NCT01958645|OG000|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
11163517|NCT01958645|OG003|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
11163518|NCT01958645|EG000|Reported Event|Placebo|Placebo (Saline solution for infusion)
11163519|NCT01958645|EG001|Reported Event|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
11163520|NCT01958645|EG002|Reported Event|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
11163521|NCT01958671|BG000|Baseline|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163522|NCT01958671|BG001|Baseline|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163523|NCT01958671|BG002|Baseline|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163524|NCT01958671|BG003|Baseline|Total|Total of all reporting groups
11163525|NCT01958671|FG000|Participant Flow|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163526|NCT01958671|FG001|Participant Flow|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163527|NCT01958671|FG002|Participant Flow|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163528|NCT01958671|OG000|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
11163529|NCT01958671|OG001|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks.
11163530|NCT01958671|OG002|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
11163531|NCT01958671|OG000|Outcome|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163532|NCT01958671|OG001|Outcome|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163533|NCT01958671|OG002|Outcome|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163534|NCT01958671|OG001|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks
11163535|NCT01958671|EG000|Reported Event|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163536|NCT01958671|EG001|Reported Event|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163537|NCT01958671|EG002|Reported Event|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
11163538|NCT01958788|BG000|Baseline|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
11163539|NCT01958788|FG000|Participant Flow|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
11163540|NCT01958788|OG000|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
11163541|NCT01958788|EG000|Reported Event|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
11163542|NCT01958827|BG000|Baseline|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
11163543|NCT01958827|FG000|Participant Flow|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
11163544|NCT01958827|OG000|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
11163545|NCT01958827|EG000|Reported Event|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
11163546|NCT01958918|BG000|Baseline|Ranibizumab|0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.
11163547|NCT01958918|BG001|Baseline|Aflibercept|2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)
11163548|NCT01958918|BG002|Baseline|Total|Total of all reporting groups
11163549|NCT01958918|FG000|Participant Flow|Ranibizumab|0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.
11163550|NCT01958918|FG001|Participant Flow|Aflibercept|2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)
11163551|NCT01958918|OG000|Outcome|Ranibizumab|0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.
11163552|NCT01958918|OG001|Outcome|Aflibercept|2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)
11163553|NCT01958918|EG000|Reported Event|Ranibizumab 0.5 mg|Ranibizumab 0.5 mg
11163554|NCT01958918|EG001|Reported Event|Aflibercept 2 mg|Aflibercept 2 mg
11163555|NCT01959035|BG000|Baseline|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
11163556|NCT01959035|FG000|Participant Flow|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month depending on the last dose that they had received in Study 14724A; 6 intramuscular (IM) injections starting at baseline
11163557|NCT01959035|OG000|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
11163558|NCT01959035|EG000|Reported Event|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
11163559|NCT01959048|BG000|Baseline|Fecal Microbiota Transplant|"fecal microbiota transplantation~fecal microbiota transplantation"
11163560|NCT01959048|FG000|Participant Flow|Fecal Microbiota Transplant|"fecal microbiota transplantation~fecal microbiota transplantation"
11163561|NCT01959048|OG000|Outcome|Fecal Microbiota Transplant|"fecal microbiota transplantation~fecal microbiota transplantation"
11163562|NCT01959048|EG000|Reported Event|Fecal Microbiota Transplant|"fecal microbiota transplantation~fecal microbiota transplantation"
11163563|NCT01959113|BG000|Baseline|Autologous Microbiome Transplant and Placebo (Split-design)|"Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.~Autologous Microbiome Transplant~Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm."
11163564|NCT01959113|FG000|Participant Flow|Autologous Microbiome Transplant and Placebo (Split-design)|"Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.~Autologous Microbiome Transplant~Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm."
11163565|NCT01959113|OG000|Outcome|Placebo Arm|"This arm will have a base moisturizer alone applied to it during the third visit.~Placebo Arm"
11163566|NCT01959113|OG001|Outcome|Autologous Microbiome Transplant|"Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.~Autologous Microbiome Transplant"
11163567|NCT01959113|EG000|Reported Event|Autologous Microbiome Transplant|"Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.~Autologous Microbiome Transplant"
11163568|NCT01959113|EG001|Reported Event|Placebo (Split-design)|Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm.
11163569|NCT01959165|BG000|Baseline|Placebo|placebo double blind phase
11163570|NCT01959165|BG001|Baseline|MEDI7183 21 mg|MEDI7183 21 mg double blind phase
11163571|NCT01959165|BG002|Baseline|MEDI7183 70 mg|MEDI7183 70 mg double blind phase
11163572|NCT01959165|BG003|Baseline|MEDI7183 210 mg|MEDI7183 210 mg double blind phase
11163573|NCT01959165|BG004|Baseline|Total|Total of all reporting groups
11163574|NCT01959165|FG000|Participant Flow|Placebo|placebo double blind phase
11163575|NCT01959165|FG001|Participant Flow|MEDI7183 21 mg|MEDI7183 21 mg double blind phase
11163576|NCT01959165|FG002|Participant Flow|MEDI7183 70 mg|MEDI7183 70 mg double blind phase
11163577|NCT01959165|FG003|Participant Flow|MEDI7183 210 mg|MEDI7183 210 mg double blind phase
11163578|NCT01959165|OG000|Outcome|Placebo|placebo double blind phase
11163579|NCT01959165|OG001|Outcome|MEDI7183 21 mg|MEDI7183 21 mg double blind phase
11163580|NCT01959165|OG002|Outcome|MEDI7183 70 mg|MEDI7183 70 mg double blind phase
11163581|NCT01959165|OG003|Outcome|MEDI7183 210 mg|MEDI7183 210 mg double blind phase
11163582|NCT01959165|EG000|Reported Event|Placebo|placebo double blind period
11163583|NCT01959165|EG001|Reported Event|MEDI7183 21 mg|MEDI7183 21 mg double blind phase
11163584|NCT01959165|EG002|Reported Event|MEDI7183 70 mg|MEDI7183 70 mg double blind period
11163585|NCT01959165|EG003|Reported Event|MEDI7183 210 mg|MEDI7183 210 mg double blind period
11163586|NCT01959178|BG000|Baseline|Overall Enrolled|Overall participants enrolled.
11163587|NCT01959178|FG000|Participant Flow|LD127025 MF Then Air Optix Aqua MF|LD127025 MF and then Air Optix Aqua MF after 1 week
11163588|NCT01959178|FG001|Participant Flow|Air Optix Aqua MF Then LD127025 MF|Air Optix Aqua MF and then LD127025 MF after 1 week
11163589|NCT01959178|OG000|Outcome|LD127025 MF|Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week.
11163590|NCT01959178|OG001|Outcome|Air Optix Aqua MF|Medium add daily disposable soft contact lens worn on a daily wear basis for one week.
11163591|NCT01959178|EG000|Reported Event|LD127025 MF|Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week.
11163592|NCT01959178|EG001|Reported Event|Air Optix Aqua MF|Medium add daily disposable soft contact lens worn on a daily wear basis for one week.
11163593|NCT01959230|BG000|Baseline|Brimonidine Tartrate|Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
11163594|NCT01959230|BG001|Baseline|Brimonidine Tartrate Vehicle|Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
11163595|NCT01959230|BG002|Baseline|Total|Total of all reporting groups
11163596|NCT01959230|FG000|Participant Flow|Brimonidine Tartrate|Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
11163597|NCT01959230|FG001|Participant Flow|Brimonidine Tartrate Vehicle|Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
11163598|NCT01959230|OG000|Outcome|Brimonidine Tartrate|Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
11163599|NCT01959230|OG001|Outcome|Brimonidine Tartrate Vehicle|Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
11163600|NCT01959230|EG000|Reported Event|Brimonidine Tartrate|Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
11163601|NCT01959230|EG001|Reported Event|Brimonidine Tartrate Vehicle|Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
11163602|NCT01959243|BG000|Baseline|Brimonidine Tartrate|Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
11163603|NCT01959243|BG001|Baseline|Brimonidine Tartrate Vehicle|Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
11163604|NCT01959243|BG002|Baseline|Total|Total of all reporting groups
11163605|NCT01959243|FG000|Participant Flow|Brimonidine Tartrate|Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
11163606|NCT01959243|FG001|Participant Flow|Brimonidine Tartrate Vehicle|Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
11163607|NCT01959243|OG000|Outcome|Brimonidine Tartrate|Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
11163608|NCT01959243|OG001|Outcome|Brimonidine Tartrate Vehicle|Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
11163609|NCT01959243|EG000|Reported Event|Brimonidine Tartrate|Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
11163610|NCT01959243|EG001|Reported Event|Brimonidine Tartrate Vehicle|Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
11163611|NCT01959334|BG000|Baseline|Glucagon IM|Glucagon dose of 1 mg administered intramuscularly as 3 doses separated by at least 7 days.
11163612|NCT01959334|BG001|Baseline|Nasal Glucagon (NG)|NG administered at 3 mg as 3 doses, separated by at least 7 days.
11163613|NCT01959334|BG002|Baseline|Total|Total of all reporting groups
11163614|NCT01959334|FG000|Participant Flow|Glucagon IM|Glucagon dose of 1 milligram (mg) administered intramuscularly as 3 doses separated by at least 7 days.
11163615|NCT01959334|FG001|Participant Flow|Nasal Glucagon (NG)|NG administered at 3 mg as 3 doses, separated by at least 7 days.
11163616|NCT01959334|OG000|Outcome|Glucagon IM|Glucagon dose of 1 mg administered intramuscularly as 3 doses separated by at least 7 days.
11163617|NCT01959334|OG001|Outcome|Nasal Glucagon (NG)|NG administered at 3 mg as 3 doses, separated by at least 7 days.
11163618|NCT01959334|EG000|Reported Event|Glucagon IM|Glucagon dose of 1 mg administered intramuscularly as 3 doses separated by at least 7 days.
11163619|NCT01959334|EG001|Reported Event|Nasal Glucagon (NG)|NG administered at 3 mg as 3 doses, separated by at least 7 days.
11163620|NCT01959347|BG000|Baseline|MUS Only|Midurethral sling alone
11163621|NCT01959347|BG001|Baseline|MUS+BPTx|Midurethral sling and behavioral/pelvic floor therapy
11163622|NCT01959347|BG002|Baseline|Total|Total of all reporting groups
11163623|NCT01959347|FG000|Participant Flow|MUS Only|Midurethral sling alone
11163624|NCT01959347|FG001|Participant Flow|MUS+BPTx|Midurethral sling and behavioral/pelvic floor therapy
11163625|NCT01959347|OG000|Outcome|MUS Only|Midurethral sling alone
11163626|NCT01959347|OG001|Outcome|MUS+BPTx|Midurethral sling and behavioral/pelvic floor therapy
11163627|NCT01959347|EG000|Reported Event|MUS Only|Midurethral sling alone
11163628|NCT01959347|EG001|Reported Event|MUS+BPTx|Midurethral sling and behavioral/pelvic floor therapy
11163629|NCT01959412|BG000|Baseline|All Participants|All participants randomized to one of six treatment sequences
11163630|NCT01959412|FG000|Participant Flow|Sequence 4 (Ind 150 μg)|indacaterol 150 μg, indacaterol 27.5 μg, indacaterol 75 μg, placebo indacaterol 55 μg indacaterol 37.5 μg Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
11163631|NCT01959412|FG001|Participant Flow|Sequence 3 (Ind 75 μg)|indacaterol 75 μg indacaterol 150 μg indacaterol 55 μg indacaterol 27.5 μg indacaterol 37.5 μg placebo Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
11163632|NCT01959412|FG002|Participant Flow|Sequence 2 (Ind 55 μg)|indacaterol 55 μg indacaterol 75 μg indacaterol 37.5 μg indacaterol 150 μg placebo indacaterol 27.5 μg Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
11163633|NCT01959412|FG003|Participant Flow|Sequence 1 (Ind 37.5 μg)|indacaterol 37.5 μg indacaterol 55μg Placebo indacaterol 75μg indacaterol 27.5μg indacaterol 150μg indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
11163634|NCT01959412|FG004|Participant Flow|Sequence 5 (Ind 27.5 μg)|indacaterol 27.5 μg placebo indacaterol 150 μg indacaterol 37.5 μg indacaterol 75 μg indacaterol 55 μg Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
11163635|NCT01959412|FG005|Participant Flow|Sequence 6 (Placebo)|Placebo, indacaterol 37.5 μg, indacaterol 27.5 μg indacaterol 55 μg, indacaterol 150 μg, indacaterol 75 μg Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
11163636|NCT01959412|OG000|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
11163637|NCT01959412|OG001|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
11163638|NCT01959412|OG002|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
11163639|NCT01959412|OG003|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
11163640|NCT01959412|OG004|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
11163641|NCT01959412|OG005|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
11163642|NCT01959412|EG000|Reported Event|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
11163643|NCT01959412|EG001|Reported Event|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
11163644|NCT01959412|EG002|Reported Event|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
11163645|NCT01959412|EG003|Reported Event|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
11163646|NCT01959412|EG004|Reported Event|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
11163647|NCT01959412|EG005|Reported Event|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
11163648|NCT01959425|BG000|Baseline|Off OAT Group (Test)|Discontinuation of OAT Therapy
11163649|NCT01959425|BG001|Baseline|On OAT Group (Control)|Continuation of OAT Therapy
11163650|NCT01959425|BG002|Baseline|Total|Total of all reporting groups
11163651|NCT01959425|FG000|Participant Flow|Off OAT Group (Test)|Discontinuation of OAT Therapy
11163652|NCT01959425|FG001|Participant Flow|On OAT Group (Control)|Continuation of OAT Therapy
11163653|NCT01959425|OG000|Outcome|Off OAT Group (Test)|Discontinuation of OAT Therapy
11163654|NCT01959425|OG001|Outcome|On OAT Group (Control)|Continuation of OAT Therapy
11163655|NCT01959425|EG000|Reported Event|Off OAT Group (Test)|Discontinuation of OAT Therapy
11163656|NCT01959425|EG001|Reported Event|On OAT Group (Control)|Continuation of OAT Therapy
11163657|NCT01959490|BG000|Baseline|Cohort 1P (HER2 Positive)|Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
11163658|NCT01959490|BG001|Baseline|Cohort 1T (HER2 Positive)|Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
11163659|NCT01959490|BG002|Baseline|Cohort II (HER2 Negative)|Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.
11163660|NCT01959490|BG003|Baseline|Total|Total of all reporting groups
11163661|NCT01959490|FG000|Participant Flow|Cohort 1P (HER2 Positive)|Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
11163662|NCT01959490|FG001|Participant Flow|Cohort 1T (HER2 Positive)|Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
11163663|NCT01959490|FG002|Participant Flow|Cohort II (HER2 Negative)|"Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks~1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15."
11163664|NCT01959490|OG000|Outcome|Cohort 1P (HER2 Positive)|Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
11163665|NCT01959490|OG001|Outcome|Cohort 1T (HER2 Positive)|Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
11163666|NCT01959490|OG002|Outcome|Cohort II (HER2 Negative)|"Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks~1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15."
11163667|NCT01959490|EG000|Reported Event|Cohort 1P (HER2 Positive)|Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
11163668|NCT01959490|EG001|Reported Event|Cohort 1T (HER2 Positive)|Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
11163669|NCT01959490|EG002|Reported Event|Cohort II (HER2 Negative)|"Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks~1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15."
11163670|NCT01959503|BG000|Baseline|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
11163671|NCT01959503|BG001|Baseline|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
11163672|NCT01959503|BG002|Baseline|Total|Total of all reporting groups
11163673|NCT01959503|FG000|Participant Flow|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
11163674|NCT01959503|FG001|Participant Flow|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
11163675|NCT01959503|OG000|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
11163676|NCT01959503|OG001|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
11163677|NCT01959503|EG000|Reported Event|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
11163678|NCT01959503|EG001|Reported Event|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
11163679|NCT01959516|BG000|Baseline|All Participants (Intent To Treat Analysis,ITT)|All participants who were randomized to one of the two treatment sequences in a ratio of 1:1. Participants will receive sequence A = glycopyrronium + placebo to tiotropium during 28 days, followed by a 14 day washout period, then sequence B= tiotropium + placebo to glycopyrronium for 28 days.
11163680|NCT01959516|FG000|Participant Flow|"Glycopyrronium First, Then Tiotropium"|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
11163681|NCT01959516|FG001|Participant Flow|Tiotropium First, Then Glycopyrronium|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
11163682|NCT01959516|OG000|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
11163683|NCT01959516|OG001|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
11163684|NCT01959516|EG000|Reported Event|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
11163685|NCT01959516|EG001|Reported Event|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
11163686|NCT01959529|BG000|Baseline|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
11163687|NCT01959529|BG001|Baseline|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
11163688|NCT01959529|BG002|Baseline|Total|Total of all reporting groups
11174324|NCT02020941|FG000|Participant Flow|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
11163689|NCT01959529|FG000|Participant Flow|Insulin Degludec|Subjects received insulin degludec (IDeg) 100 units/mL once daily (OD) subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with insulin aspart (IAsp) at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin twice daily (BID), the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
11163690|NCT01959529|FG001|Participant Flow|Insulin Glargine|Subjects received insulin glargine (IGlar) 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
11163691|NCT01959529|OG000|Outcome|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
11163692|NCT01959529|OG001|Outcome|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
11163693|NCT01959529|EG000|Reported Event|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
11163694|NCT01959529|EG001|Reported Event|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
11163695|NCT01959542|BG000|Baseline|MRIs and PSA Blood Test|"Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI~Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI~Visit 3 (on last day of EBRT): PSA blood test~Visit 4 (6 months after starting ADT): PSA blood test and prostate MRI~MRI~PSA Blood Test: Serum PSA will also be subsequently checked on the same day as each follow-up MR is performed, i.e. TP 1, 2 and 3, and right after finishing EBRT. 1-2 mls of blood will be sampled per blood test.~Androgen Deprivation Therapy (ADT): Patients will receive ADT as part of their standard clinical care, as determined by their clinician.~External Beam Radiation Therapy (EBRT): Patients will receive EBRT as part of their standard clinical care, as determined by their clinician."
11163696|NCT01959542|FG000|Participant Flow|Single Arm|All enrolled patients undergo PSA sampling and prostate MRI. No control arm.
11163697|NCT01959542|OG000|Outcome|Single Arm|All enrolled patients undergo PSA sampling and prostate MRI. No control arm.
11163698|NCT01959542|OG000|Outcome|MRIs and PSA Blood Test|All enrolled patients undergo PSA sampling and prostate MRI. No control arm.
11163699|NCT01959542|EG000|Reported Event|Single Arm|All enrolled patients undergo PSA sampling and prostate MRI. No control arm.
11163700|NCT01959581|BG000|Baseline|Movement Enhancing Device|"Guided play while wearing a movement assisting device~Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
11163701|NCT01959581|FG000|Participant Flow|Movement Enhancing Device|"Guided play while wearing a movement assisting device~Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
11163702|NCT01959581|OG000|Outcome|Movement Enhancing Device|"Guided play while wearing a movement assisting device~Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
11163703|NCT01959581|EG000|Reported Event|Movement Enhancing Device|"Guided play while wearing a movement assisting device~Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
11163704|NCT01959607|BG000|Baseline|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
11163705|NCT01959607|BG001|Baseline|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
11163706|NCT01959607|BG002|Baseline|Total|Total of all reporting groups
11163707|NCT01959607|FG000|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of CC)."
11163708|NCT01959607|FG001|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
11163709|NCT01959607|FG002|Participant Flow|THS 2.2 Then NRT|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NRT gum [Nicorette ® 2mg])."
11163710|NCT01959607|FG003|Participant Flow|NRT Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NRT gum [Nicorette ® 2mg])~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
11163711|NCT01959607|OG000|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
11163712|NCT01959607|OG001|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
11163713|NCT01959607|OG002|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
11163714|NCT01959607|OG003|Outcome|NRT - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
11163715|NCT01959607|EG000|Reported Event|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
11163716|NCT01959607|EG001|Reported Event|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
11163717|NCT01959607|EG002|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
11163718|NCT01959672|BG000|Baseline|Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)|"CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.~IMMUNOTHERAPY: Patients with CA125 level >= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.~STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18."
11163719|NCT01959672|FG000|Participant Flow|Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)|"CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.~IMMUNOTHERAPY: Patients with CA125 level >= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.~STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18."
11163720|NCT01959672|OG000|Outcome|Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)|"CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.~IMMUNOTHERAPY: Patients with CA125 level >= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.~STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18."
11163721|NCT01959672|OG000|Outcome|Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)|"CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.~IMMUNOTHERAPY: Patients with CA125 level >= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level.~STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days.~NELFINAVIR: PO BID for 5 weeks beginning in week 9.~SURGERY: week 17-18."
11163722|NCT01959672|OG000|Outcome|Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)|"CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.~IMMUNOTHERAPY: Patients with CA125 level >= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level.~STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, 2-13).~NELFINAVIR MESYLATE: PO BID for 5 weeks beginning in week 9.~SURGERY: week 17-18."
11163723|NCT01959672|OG000|Outcome|Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)|"CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.~IMMUNOTHERAPY: Patients with CA125 level >= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level.~STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days.~NELFINAVIR MESYLATE: PO BID for 5 weeks beginning in week 9.~SURGERY: week 17-18."
11163724|NCT01959672|EG000|Reported Event|Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)|"CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.~IMMUNOTHERAPY: Patients with CA125 level >= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.~STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18."
11163725|NCT01959685|BG000|Baseline|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
11163726|NCT01959685|FG000|Participant Flow|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
11163727|NCT01959685|OG000|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
11163728|NCT01959685|EG000|Reported Event|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
11163729|NCT01959698|BG000|Baseline|Dose Level 1: Carfilzomib 10mg/m2(d1-2; d8-9)(Carfilzomib, Rituximab, Chemotherapy)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163730|NCT01959698|BG001|Baseline|Dose Level 2: Carfilzomib 15mg/m2(d1-2; d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163731|NCT01959698|BG002|Baseline|Dose Level 3: Carfilzomib 20mg/m2(d1-2; d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163732|NCT01959698|BG003|Baseline|Dose Level 4: Carfilzomib 20mg/m2(d1-2); 27mg/m2(d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11233891|NCT02431468|BG001|Baseline|Bryostatin 1 40ug|"Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11163733|NCT01959698|BG004|Baseline|Dose Level 5: Carfilzomib 20mg/m2(d1-2); 36mg/m2(d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163734|NCT01959698|BG005|Baseline|Dose Level 6: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163735|NCT01959698|BG006|Baseline|Expansion Cohort: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163736|NCT01959698|BG007|Baseline|Total|Total of all reporting groups
11163737|NCT01959698|FG000|Participant Flow|Dose Level 1: Carfilzomib 10mg/m2 (d1-2; d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163738|NCT01959698|FG001|Participant Flow|Dose Level 2: Carfilzomib 15mg/m2(d1-2; d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163739|NCT01959698|FG002|Participant Flow|Dose Level 3: Carfilzomib 20mg/m2(d1-2; d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163740|NCT01959698|FG003|Participant Flow|Dose Level 4: Carfilzomib 20mg/m2(d1-2); 27mg/m2(d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163741|NCT01959698|FG004|Participant Flow|Dose Level 5: Carfilzomib 20mg/m2(d1-2); 36mg/m2(d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163742|NCT01959698|FG005|Participant Flow|Dose Level 6: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163743|NCT01959698|FG006|Participant Flow|Expansion Cohort: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163744|NCT01959698|OG000|Outcome|Treatment (Carfilzomib, Rituximab, Chemotherapy)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163745|NCT01959698|OG000|Outcome|Dose Level 1: Carfilzomib 10mg/m2(d1-2; d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163746|NCT01959698|OG001|Outcome|Dose Level 2: Carfilzomib 15mg/m2(d1-2; d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163747|NCT01959698|OG002|Outcome|Dose Level 3: Carfilzomib 20mg/m2(d1-2; d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163748|NCT01959698|OG003|Outcome|Dose Level 4: Carfilzomib 20mg/m2(d1-2); 27mg/m2(d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163749|NCT01959698|OG004|Outcome|Dose Level 5: Carfilzomib 20mg/m2(d1-2); 36mg/m2(d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163750|NCT01959698|OG005|Outcome|Dose Level 6: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163751|NCT01959698|OG006|Outcome|Expansion Cohort: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)|Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
11163752|NCT01959698|EG000|Reported Event|Dose Level 1: Carfilzomib 10mg/m2(d1-2; d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163753|NCT01959698|EG001|Reported Event|Dose Level 2: Carfilzomib 15mg/m2(d1-2; d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163754|NCT01959698|EG002|Reported Event|Dose Level 3: Carfilzomib 20mg/m2(d1-2; d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163755|NCT01959698|EG003|Reported Event|Dose Level 4: Carfilzomib 20mg/m2(d1-2); 27mg/m2(d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163756|NCT01959698|EG004|Reported Event|Dose Level 5: Carfilzomib 20mg/m2(d1-2); 36mg/m2(d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163757|NCT01959698|EG005|Reported Event|Dose Level 6: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163758|NCT01959698|EG006|Reported Event|Expansion Cohort: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)|"Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Carfilzomib: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Rituximab: Given IV"
11163759|NCT01959841|BG000|Baseline|ASP2151(200 mg)|"once daily~ASP2151: 200 mg once daily or 400 mg once daily"
11163760|NCT01959841|BG001|Baseline|ASP2151(400mg)|"once daily~ASP2151: 200 mg once daily or 400 mg once daily"
11163761|NCT01959841|BG002|Baseline|Valaciclovir|"1000 mg three times daily~valaciclovir: 1000 mg three times daily"
11163762|NCT01959841|BG003|Baseline|Total|Total of all reporting groups
11163763|NCT01959841|FG000|Participant Flow|ASP2151(200 mg)|"once daily~ASP2151: 200 mg once daily or 400 mg once daily"
11163764|NCT01959841|FG001|Participant Flow|ASP2151(400mg)|"once daily~ASP2151: 200 mg once daily or 400 mg once daily"
11163765|NCT01959841|FG002|Participant Flow|Valaciclovir|"1000 mg three times daily~valaciclovir: 1000 mg three times daily"
11163766|NCT01959841|OG000|Outcome|ASP2151(200 mg)|"once daily~ASP2151: 200 mg once daily or 400 mg once daily"
11163767|NCT01959841|OG001|Outcome|ASP2151(400mg)|"once daily~ASP2151: 200 mg once daily or 400 mg once daily"
11163768|NCT01959841|OG002|Outcome|Valaciclovir|"1000 mg three times daily~valaciclovir: 1000 mg three times daily"
11163769|NCT01959841|EG000|Reported Event|ASP2151(200 mg)|"once daily~ASP2151: 200 mg once daily or 400 mg once daily"
11163770|NCT01959841|EG001|Reported Event|ASP2151(400mg)|"once daily~ASP2151: 200 mg once daily or 400 mg once daily"
11163771|NCT01959841|EG002|Reported Event|Valaciclovir|"1000 mg three times daily~valaciclovir: 1000 mg three times daily"
11163772|NCT01959880|BG000|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
11163773|NCT01959880|BG001|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
11163774|NCT01959880|BG002|Baseline|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
11163775|NCT01959880|BG003|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
11163776|NCT01959880|BG004|Baseline|Total|Total of all reporting groups
11163777|NCT01959880|FG000|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
11163778|NCT01959880|FG001|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
11163779|NCT01959880|FG002|Participant Flow|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
11163780|NCT01959880|FG003|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
11163781|NCT01959880|OG000|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
11163782|NCT01959880|OG001|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
11163783|NCT01959880|OG002|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
11163784|NCT01959880|OG003|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
11163785|NCT01959880|EG000|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
11163786|NCT01959880|EG001|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
11163787|NCT01959880|EG002|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
11163788|NCT01959880|EG003|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
11163789|NCT01959919|BG000|Baseline|Refacto AF FuseNGo|Participants with haemophilia A, who were receiving clotting factor VIII treatment prior to enrollment in this study, used Refacto AF FuseNGo (intravenous infusion of moroctocog alfa, a human recombinant clotting factor VIII, delivered by system FuseNGo) either prophylactically or on-demand and were observed for maximum up to Week 52. Dosage and use of Refacto AF FuseNGo was based on investigator's judgement according to approved SmPC.
11163790|NCT01959919|FG000|Participant Flow|Refacto AF FuseNGo|Participants with haemophilia A, who were receiving clotting factor VIII treatment prior to enrollment in this study, used Refacto AF FuseNGo (intravenous infusion of moroctocog alfa, a human recombinant clotting factor VIII, delivered by system FuseNGo) either prophylactically or on-demand and were observed for maximum up to Week 52. Dosage and use of Refacto AF FuseNGo was based on investigator's judgement according to approved summary of product characteristics (SmPC).
11163791|NCT01959919|OG000|Outcome|Refacto AF FuseNGo|Participants with haemophilia A, who were receiving clotting factor VIII treatment prior to enrollment in this study, used Refacto AF FuseNGo (intravenous infusion of moroctocog alfa, a human recombinant clotting factor VIII, delivered by system FuseNGo) either prophylactically or on-demand and were observed for maximum up to Week 52. Dosage and use of Refacto AF FuseNGo was based on investigator's judgement according to approved SmPC.
11163792|NCT01959919|EG000|Reported Event|Refacto AF FuseNGo|Participants with haemophilia A, who were receiving clotting factor VIII treatment prior to enrollment in this study, used Refacto AF FuseNGo (intravenous infusion of moroctocog alfa, a human recombinant clotting factor VIII, delivered by system FuseNGo) either prophylactically or on-demand and were observed for maximum up to Week 52. Dosage and use of Refacto AF FuseNGo was based on investigator's judgement according to approved SmPC.
11163793|NCT01959932|BG000|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
11163794|NCT01959932|BG001|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11163795|NCT01959932|BG002|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
11163796|NCT01959932|BG003|Baseline|Total|Total of all reporting groups
11163797|NCT01959932|FG000|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
11163798|NCT01959932|FG001|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11163799|NCT01959932|FG002|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
11163800|NCT01959932|OG000|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
11163801|NCT01959932|OG001|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11163802|NCT01959932|OG002|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
11163803|NCT01959932|EG000|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
11163804|NCT01959932|EG001|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
11163805|NCT01959932|EG002|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11163806|NCT01959932|EG003|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
11163807|NCT01959945|BG000|Baseline|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163808|NCT01959945|BG001|Baseline|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163809|NCT01959945|BG002|Baseline|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163810|NCT01959945|BG003|Baseline|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163811|NCT01959945|BG004|Baseline|Total|Total of all reporting groups
11163812|NCT01959945|FG000|Participant Flow|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163813|NCT01959945|FG001|Participant Flow|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163814|NCT01959945|FG002|Participant Flow|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163815|NCT01959945|FG003|Participant Flow|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163816|NCT01959945|OG000|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163817|NCT01959945|OG001|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163818|NCT01959945|OG002|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163819|NCT01959945|OG003|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163820|NCT01959945|OG001|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163821|NCT01959945|OG002|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163822|NCT01959945|EG000|Reported Event|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163823|NCT01959945|EG001|Reported Event|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163824|NCT01959945|EG002|Reported Event|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163825|NCT01959945|EG003|Reported Event|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
11163826|NCT01960075|BG000|Baseline|Fosphenytoin (FOS)|"Administer 20 mg/Kg fosphenytoin intravenously up to a maximum dose of 1500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 1500 fosphenytoin over 10 minutes.~Fosphenytoin"
11163827|NCT01960075|BG001|Baseline|Valproic Acid|"Administer 40 mg/Kg valproic acid intravenously up to a maximum dose of 3000 mg (75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 3000 valproic acidover 10 minutes.~Valproic acid"
11163828|NCT01960075|BG002|Baseline|Levetiracetam|"Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.~Levetiracetam"
11163829|NCT01960075|BG003|Baseline|Total|Total of all reporting groups
11163830|NCT01960075|FG000|Participant Flow|Fosphenytoin (FOS)|"Administer 20 mg/Kg fosphenytoin intravenously up to a maximum dose of 1500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 1500 fosphenytoin over 10 minutes.~Fosphenytoin"
11163831|NCT01960075|FG001|Participant Flow|Valproic Acid|"Administer 40 mg/Kg valproic acid intravenously up to a maximum dose of 3000 mg (75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 3000 valproic acidover 10 minutes.~Valproic acid"
11163832|NCT01960075|FG002|Participant Flow|Levetiracetam|"Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.~Levetiracetam"
11163833|NCT01960075|OG000|Outcome|Fosphenytoin (FOS)|"Administer 20 mg/Kg fosphenytoin intravenously up to a maximum dose of 1500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 1500 fosphenytoin over 10 minutes.~Fosphenytoin"
11163834|NCT01960075|OG001|Outcome|Valproic Acid|"Administer 40 mg/Kg valproic acid intravenously up to a maximum dose of 3000 mg (75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 3000 valproic acidover 10 minutes.~Valproic acid"
11163835|NCT01960075|OG002|Outcome|Levetiracetam|"Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.~Levetiracetam"
11163836|NCT01960075|EG000|Reported Event|Fosphenytoin (FOS)|"Administer 20 mg/Kg fosphenytoin intravenously up to a maximum dose of 1500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 1500 fosphenytoin over 10 minutes.~Fosphenytoin"
11163837|NCT01960075|EG001|Reported Event|Valproic Acid|"Administer 40 mg/Kg valproic acid intravenously up to a maximum dose of 3000 mg (75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 3000 valproic acidover 10 minutes.~Valproic acid"
11163838|NCT01960075|EG002|Reported Event|Levetiracetam|"Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.~Levetiracetam"
11163839|NCT01960114|BG000|Baseline|Placebo|Placebo (two matching placebo tablets)
11163840|NCT01960114|BG001|Baseline|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
11163841|NCT01960114|BG002|Baseline|Total|Total of all reporting groups
11163842|NCT01960114|FG000|Participant Flow|Placebo|Placebo (two matching placebo tablets)
11163843|NCT01960114|FG001|Participant Flow|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
11163844|NCT01960114|OG000|Outcome|Placebo|Placebo (two matching placebo tablets)
11163845|NCT01960114|OG001|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
11163846|NCT01960114|EG000|Reported Event|Placebo|Placebo (two matching placebo tablets)
11163847|NCT01960114|EG001|Reported Event|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
11163848|NCT01960140|BG000|Baseline|Simvastatin Then Baricitinib and Simvastatin|"Period 1: 40-mg tablet of simvastatin administered orally on Day 1.~Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6."
11163849|NCT01960140|FG000|Participant Flow|Simvastatin Then Baricitinib and Simvastatin|"Period 1: 40-milligram (mg) tablet of simvastatin administered orally on Day 1.~Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally once daily (QD) on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6."
11163850|NCT01960140|OG000|Outcome|Simvastatin|Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
11163851|NCT01960140|OG001|Outcome|Baricitinib and Simvastatin|Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
11163852|NCT01960140|OG001|Outcome|Baricitinib and Simvastatin|Period 2: 10-mg dose of Baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
11163853|NCT01960140|EG000|Reported Event|Simvastatin|"A 40-mg tablet of simvastatin administered orally on Day 1.~Adverse events (AEs) are reported from baseline through predose on Day 3."
11163854|NCT01960140|EG001|Reported Event|Baricitinib|"A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 5.~AEs are reported postdose on Day 3 through predose on Day 6."
11163855|NCT01960140|EG002|Reported Event|Baricitinib and Simvastatin|"A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 6 and 7, with coadministration of 40-mg simvastatin tablet on Day 6.~AEs are reported postdose on Day 6 up to Day 18."
11233892|NCT02431468|BG002|Baseline|Placebo|"Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution."
11233893|NCT02431468|BG003|Baseline|Total|Total of all reporting groups
11163856|NCT01960257|BG000|Baseline|ALL PARTICIPANTS|"Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) co-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~SOC DOT~Digital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications."
11163857|NCT01960257|FG000|Participant Flow|WOT+ SOC DOT|"Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) co-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~Digital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications."
11163858|NCT01960257|FG001|Participant Flow|Wirelessly Observed Therapy (WOT)|IS-Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) co-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.
11163859|NCT01960257|FG002|Participant Flow|Directly Observed Therapy (DOT)|"Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~SOC DOT"
11163860|NCT01960257|OG000|Outcome|DHFS With IS-RM Plus SOC DOT|Initially all participants (n=77) received DHFS IS-RM in conjunction with witnessed medication doses (DOT) for 2-3 weeks to allow calculation of DHFS IS-RM PDA, and the 95% confidence interval (CI) was estimated using the bootstrap method with 10,000 samples.
11163861|NCT01960257|OG000|Outcome|Wirelessly Observed Therapy (WOT)|"IS-Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) co-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~Digital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications."
11163862|NCT01960257|OG001|Outcome|SOC DOT|"Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~SOC DOT"
11163863|NCT01960257|OG000|Outcome|Stage 1: DHFS With IS-RM Plus SOC DOT|Initially all participants (n=77) received DHFS IS-RM in conjunction with witnessed medication doses (DOT) for 2-3 weeks to allow calculation of DHFS IS-RM PDA, and the 95% confidence interval (CI) was estimated using the bootstrap method with 10,000 samples.
11163864|NCT01960257|OG001|Outcome|Stage 2: DHFS With IS-RM|n=41 participants were randomized to the Intervention Group that used DHFS with IS-RM without concurrent DOT for TB treatment monitoring
11163865|NCT01960257|EG000|Reported Event|WOT+ SOC DOT|"Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) over-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~Digital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications."
11163866|NCT01960257|EG001|Reported Event|Wirelessly Observed Therapy (WOT)|"IS-enabled combination isoniazid 150 mg/rifampin 300 mg (IS-Rifamate) over-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~Digital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications."
11163867|NCT01960257|EG002|Reported Event|Directly Observed Therapy (DOT)|"Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.~SOC DOT"
11163868|NCT01960296|BG000|Baseline|Clopidogrel|Continue home dose of clopidogrel into surgery
11163869|NCT01960296|BG001|Baseline|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
11163870|NCT01960296|BG002|Baseline|Total|Total of all reporting groups
11163871|NCT01960296|FG000|Participant Flow|Clopidogrel|Continue home dose of clopidogrel into surgery
11163872|NCT01960296|FG001|Participant Flow|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
11163873|NCT01960296|OG000|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
11163874|NCT01960296|OG001|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
11163875|NCT01960296|EG000|Reported Event|Clopidogrel|Continue home dose of clopidogrel into surgery
11163876|NCT01960296|EG001|Reported Event|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
11163877|NCT01960348|BG000|Baseline|Patisiran (ALN-TTR02)|All patients who received at least 1 dose of patisiran (ALN-TTR02)
11163878|NCT01960348|BG001|Baseline|Placebo|All patients who received at least 1 dose of placebo
11163879|NCT01960348|BG002|Baseline|Total|Total of all reporting groups
11163880|NCT01960348|FG000|Participant Flow|Patisiran (ALN-TTR02)|All patients who received at least 1 dose of patisiran (ALN-TTR02)
11163881|NCT01960348|FG001|Participant Flow|Placebo|All patients who received at least 1 dose of placebo
11163882|NCT01960348|OG000|Outcome|Patisiran (ALN-TTR02)|All patients who received at least 1 dose of patisiran (ALN-TTR02)
11163883|NCT01960348|OG001|Outcome|Placebo|All patients who received at least 1 dose of placebo
11163884|NCT01960348|EG000|Reported Event|Patisiran (ALN-TTR02)|All patients who received at least 1 dose of patisiran (ALN-TTR02)
11163885|NCT01960348|EG001|Reported Event|Placebo|All patients who received at least 1 dose of placebo
11163886|NCT01960387|BG000|Baseline|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
11163887|NCT01960387|FG000|Participant Flow|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
11163888|NCT01960387|OG000|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
11163889|NCT01960387|EG000|Reported Event|Clofarabine (40mg/m2/Day) + Cytarabine (1g/m2/Day)|Patients with Newly Diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m2 daily plus cytarabine at a dose of 1g/m2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration, on days 1 through 5.
11163890|NCT01960400|BG000|Baseline|GMI + tDCS|"Graded motor imagery (GMI) + tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
11163891|NCT01960400|BG001|Baseline|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
11163892|NCT01960400|BG002|Baseline|Total|Total of all reporting groups
11163893|NCT01960400|FG000|Participant Flow|GMI + tDCS|"Graded motor imagery (GMI) + tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
11163894|NCT01960400|FG001|Participant Flow|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
11163895|NCT01960400|OG000|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
11163896|NCT01960400|OG001|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
11163897|NCT01960400|EG000|Reported Event|GMI + Active tDCS|Graded motor imagery (GMI) + active tDCS
11163898|NCT01960400|EG001|Reported Event|GMI + Placebo tDCS|Graded motor imagery (GMI) + placebo tDCS
11163899|NCT01960413|BG000|Baseline|Montelukast Added to Hydroxyurea|"Oral montelukast therapy taken daily for eight weeks with current hydroxyurea regiment~Montelukast added to Hydroxyurea"
11163900|NCT01960413|BG001|Baseline|Placebo Added to Hydroxyurea|"Oral placebo taken daily for eight weeks with current hydroxyurea regiment~Placebo added to Hydroxyurea"
11163901|NCT01960413|BG002|Baseline|Total|Total of all reporting groups
11163902|NCT01960413|FG000|Participant Flow|Montelukast Added to Hydroxyurea|"Oral montelukast therapy taken daily for eight weeks with current hydroxyurea regiment~Montelukast added to Hydroxyurea"
11163903|NCT01960413|FG001|Participant Flow|Placebo Added to Hydroxyurea|"Oral placebo taken daily for eight weeks with current hydroxyurea regiment~Placebo added to Hydroxyurea"
11163904|NCT01960413|OG000|Outcome|Montelukast Added to Hydroxyurea|"Oral montelukast therapy taken daily for eight weeks with current hydroxyurea regiment~Montelukast added to Hydroxyurea"
11163905|NCT01960413|OG001|Outcome|Placebo Added to Hydroxyurea|"Oral placebo taken daily for eight weeks with current hydroxyurea regiment~Placebo added to Hydroxyurea"
11163906|NCT01960413|EG000|Reported Event|Montelukast Added to Hydroxyurea|"Oral montelukast therapy taken daily for eight weeks with current hydroxyurea regiment~Montelukast added to Hydroxyurea"
11163907|NCT01960413|EG001|Reported Event|Placebo Added to Hydroxyurea|"Oral placebo taken daily for eight weeks with current hydroxyurea regiment~Placebo added to Hydroxyurea"
11163908|NCT01960465|BG000|Baseline|African Americans|"138 Self identified African American~Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea."
11163909|NCT01960465|BG001|Baseline|Non African Americans|"53 Caucasians and 29 Other race (non African-Americans) Veterans.~Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea."
11163910|NCT01960465|BG002|Baseline|Total|Total of all reporting groups
11163911|NCT01960465|FG000|Participant Flow|African Americans|"138 Self identified African American~Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea."
11163912|NCT01960465|FG001|Participant Flow|Non African Americans|"53 Caucasians and 29 Other race (non African-Americans) Veterans.~Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea."
11163913|NCT01960465|OG000|Outcome|African Americans|"138 Self identified African American~Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea."
11163914|NCT01960465|OG001|Outcome|Non African Americans|"82 Other race (non African Americans) Veterans.~Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea."
11163915|NCT01960465|EG000|Reported Event|African Americans|"138 Self identified African American~Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea."
11163916|NCT01960465|EG001|Reported Event|Non African Americans|"82 Other race (non African Americans) Veterans.~Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea."
11163917|NCT01960725|BG000|Baseline|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
11163918|NCT01960725|BG001|Baseline|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
11163919|NCT01960725|BG002|Baseline|Total|Total of all reporting groups
11163920|NCT01960725|FG000|Participant Flow|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
11163921|NCT01960725|FG001|Participant Flow|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
11163922|NCT01960725|OG000|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
11163923|NCT01960725|OG001|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
11163924|NCT01960725|EG000|Reported Event|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
11163925|NCT01960725|EG001|Reported Event|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
11163926|NCT01960790|BG000|Baseline|Participants Who Received Humira®|Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
11163927|NCT01960790|FG000|Participant Flow|Participants Who Received Humira®|Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
11163928|NCT01960790|OG000|Outcome|Participants Who Received Humira®|Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
11163929|NCT01960790|EG000|Reported Event|Participants Who Received Humira®|Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
11163930|NCT01960816|BG000|Baseline|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
11163931|NCT01960816|FG000|Participant Flow|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
11163932|NCT01960816|OG000|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
11163933|NCT01960816|EG000|Reported Event|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
11163934|NCT01960842|BG000|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
11163935|NCT01960842|FG000|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
11163936|NCT01960842|OG000|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
11163937|NCT01960842|EG000|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
11163938|NCT01960855|BG000|Baseline|Placebo BID|Placebo twice daily (BID) for 12 weeks.
11163939|NCT01960855|BG001|Baseline|ABT-494 3 mg BID|ABT-494 3 mg twice daily (BID) for 12 weeks.
11163940|NCT01960855|BG002|Baseline|ABT-494 6 mg BID|ABT-494 6 mg twice daily (BID) for 12 weeks.
11163941|NCT01960855|BG003|Baseline|ABT-494 12 mg BID|ABT-494 12 mg twice daily (BID) for 12 weeks.
11163942|NCT01960855|BG004|Baseline|ABT-494 18 mg BID|ABT-494 18 mg twice daily (BID) for 12 weeks.
11163943|NCT01960855|BG005|Baseline|Total|Total of all reporting groups
11163944|NCT01960855|FG000|Participant Flow|Placebo BID|Placebo twice daily (BID) for 12 weeks.
11163945|NCT01960855|FG001|Participant Flow|ABT-494 3 mg BID|ABT-494 3 mg twice daily (BID) for 12 weeks.
11163946|NCT01960855|FG002|Participant Flow|ABT-494 6 mg BID|ABT-494 6 mg twice daily (BID) for 12 weeks.
11163947|NCT01960855|FG003|Participant Flow|ABT-494 12 mg BID|ABT-494 12 mg twice daily (BID) for 12 weeks.
11163948|NCT01960855|FG004|Participant Flow|ABT-494 18 mg BID|ABT-494 18 mg twice daily (BID) for 12 weeks.
11163949|NCT01960855|OG000|Outcome|Placebo BID|Placebo twice daily (BID) for 12 weeks.
11163950|NCT01960855|OG001|Outcome|ABT-494 3 mg BID|ABT-494 3 mg twice daily (BID) for 12 weeks.
11163951|NCT01960855|OG002|Outcome|ABT-494 6 mg BID|ABT-494 6 mg twice daily (BID) for 12 weeks.
11163952|NCT01960855|OG003|Outcome|ABT-494 12 mg BID|ABT-494 12 mg twice daily (BID) for 12 weeks.
11163953|NCT01960855|OG004|Outcome|ABT-494 18 mg BID|ABT-494 18 mg twice daily (BID) for 12 weeks.
11163954|NCT01960855|EG000|Reported Event|Placebo BID|Placebo twice daily (BID) for 12 weeks.
11163955|NCT01960855|EG001|Reported Event|ABT-494 3 mg BID|ABT-494 3 mg twice daily (BID) for 12 weeks.
11163956|NCT01960855|EG002|Reported Event|ABT-494 6 mg BID|ABT-494 6 mg twice daily (BID) for 12 weeks.
11163957|NCT01960855|EG003|Reported Event|ABT-494 12 mg BID|ABT-494 12 mg twice daily (BID) for 12 weeks.
11163958|NCT01960855|EG004|Reported Event|ABT-494 18 mg BID|ABT-494 18 mg twice daily (BID) for 12 weeks.
11163959|NCT01960907|BG000|Baseline|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
11163960|NCT01960907|BG001|Baseline|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
11163961|NCT01960907|BG002|Baseline|Total|Total of all reporting groups
11163962|NCT01960907|FG000|Participant Flow|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS."
11163963|NCT01960907|FG001|Participant Flow|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
11163964|NCT01960907|OG000|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
11163965|NCT01960907|OG001|Outcome|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
11163966|NCT01960907|OG000|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS."
11163967|NCT01960907|OG000|Outcome|Monitored, Previously Hopitalized for COPD Exacerbation|Patients in the monitored group that were hospitalized the year before the study for a COPD exacerbation
11163968|NCT01960907|OG001|Outcome|Observational, Previously Hopitalized for COPD Exacerb.|Patients in the observational group that were hospitalized the year before the study for a COPD exacerbation
11163969|NCT01960907|EG000|Reported Event|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
11163970|NCT01960907|EG001|Reported Event|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
11163971|NCT01960998|BG000|Baseline|Telehealth With Pelvic Floor Muscle Training|"Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures.~Pelvic Floor Muscle Training: Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website~Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively."
11163972|NCT01960998|BG001|Baseline|Telehealth Without Pelvic Floor Muscle Training|"Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.~Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively."
11163973|NCT01960998|BG002|Baseline|Total|Total of all reporting groups
11163974|NCT01960998|FG000|Participant Flow|Telehealth With Pelvic Floor Muscle Training|"Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1 month before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures.~Pelvic Floor Muscle Training: Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 2-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website~Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively."
11233894|NCT02431468|FG000|Participant Flow|Bryostatin 1 20ug|"Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11163975|NCT01960998|FG001|Participant Flow|Telehealth Without Pelvic Floor Muscle Training|"Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 3 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.~Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively."
11163976|NCT01960998|OG000|Outcome|Telehealth With Pelvic Floor Muscle Training|Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training was begun 1-4 weeks before surgery and continued 2 months after surgery. Content was accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
11163977|NCT01960998|OG001|Outcome|Telehealth Without Pelvic Floor Muscle Training|Participants in this group received a telehealth program that included general perioperative care; wetness, odor and skin care management; and outcome measures. The program was begun 1-4 weeks before surgery and continued 2 months after surgery. Content was accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.
11163978|NCT01960998|OG000|Outcome|Telehealth With Pelvic Floor Muscle Training|Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures.
11163979|NCT01960998|OG001|Outcome|Telehealth Without Pelvic Floor Muscle Training|Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.
11163980|NCT01960998|EG000|Reported Event|Telehealth With Pelvic Floor Muscle Training|"Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures.~Pelvic Floor Muscle Training: Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website~Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively."
11163981|NCT01960998|EG001|Reported Event|Telehealth Without Pelvic Floor Muscle Training|"Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.~Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively."
11163982|NCT01961089|BG000|Baseline|Device|"Galilei Lens Professional versus predicate devices~Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG)"
11163983|NCT01961089|FG000|Participant Flow|Device|"Galilei Lens Professional versus predicate devices:~Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG)"
11163984|NCT01961089|OG000|Outcome|Device|Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
11163985|NCT01961089|EG000|Reported Event|Device|Galilei G6 Lens Professional versus IOLMaster and Lenstar
11163986|NCT01961115|BG000|Baseline|Cohort A|Pts. enrolled >6 wks after failing anti-PD-1/PDL-1 INCB024360 - 300 mg po bid continuous for 98 days MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98
11163987|NCT01961115|BG001|Baseline|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~INCB024360 - 100 mg po bid continuous for 98 days~MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98"
11163988|NCT01961115|BG002|Baseline|All Other Patients|All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria INCB024360 - 300 mg po bid continuous for 98 days MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98
11163989|NCT01961115|BG003|Baseline|Total|Total of all reporting groups
11163990|NCT01961115|FG000|Participant Flow|Cohort A|"Cohort A - Pts. enrolled >6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days All other pts. - received 300 mg po BID~All pts received MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98"
11163991|NCT01961115|FG001|Participant Flow|Cohort B|Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days
11163992|NCT01961115|FG002|Participant Flow|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
11163993|NCT01961115|OG000|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
11163994|NCT01961115|OG001|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
11163995|NCT01961115|OG002|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
11163996|NCT01961115|EG000|Reported Event|Cohort A|Pts. enrolled >6 wks after failing anti-PD-1/PDL-1
11163997|NCT01961115|EG001|Reported Event|Cohort B|Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1
11163998|NCT01961115|EG002|Reported Event|All Other Patients|"Pts. enrolled who have not been treated with check point inhibition~100 mg INCB024360 po bid continuous for 98 days~MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98~Laboratory Biomarker Analysis: Correlative studies"
11163999|NCT01961167|BG000|Baseline|Iliac Stenting|"Balloon expandable stenting of iliac occlusive disease~Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease"
11164000|NCT01961167|FG000|Participant Flow|Gore VIABAHN BX|"Balloon expandable stenting of iliac occlusive disease~Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease"
11164001|NCT01961167|OG000|Outcome|Iliac Stenting|"Balloon expandable stenting of iliac occlusive disease~Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease"
11164002|NCT01961167|EG000|Reported Event|Iliac Stenting|"Balloon expandable stenting of iliac occlusive disease~Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease"
11164003|NCT01961271|BG000|Baseline|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
11164004|NCT01961271|FG000|Participant Flow|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
11164005|NCT01961271|OG000|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
11164006|NCT01961271|EG000|Reported Event|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
11164007|NCT01961297|BG000|Baseline|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
11164008|NCT01961297|BG001|Baseline|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
11164009|NCT01961297|BG002|Baseline|Total|Total of all reporting groups
11164010|NCT01961297|FG000|Participant Flow|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
11164011|NCT01961297|FG001|Participant Flow|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
11164012|NCT01961297|OG000|Outcome|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
11164013|NCT01961297|OG001|Outcome|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
11164014|NCT01961297|EG000|Reported Event|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
11164015|NCT01961297|EG001|Reported Event|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
11164016|NCT01961323|BG000|Baseline|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
11164017|NCT01961323|FG000|Participant Flow|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
11164018|NCT01961323|OG000|Outcome|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
11164019|NCT01961323|EG000|Reported Event|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
11164020|NCT01961349|BG000|Baseline|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
11164021|NCT01961349|BG001|Baseline|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
11164022|NCT01961349|BG002|Baseline|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
11164023|NCT01961349|BG003|Baseline|Total|Total of all reporting groups
11164024|NCT01961349|FG000|Participant Flow|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
11164025|NCT01961349|FG001|Participant Flow|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
11164026|NCT01961349|FG002|Participant Flow|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
11164027|NCT01961349|OG000|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
11164028|NCT01961349|OG001|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
11164029|NCT01961349|OG002|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
11164030|NCT01961349|EG000|Reported Event|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
11164031|NCT01961349|EG001|Reported Event|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
11164032|NCT01961349|EG002|Reported Event|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
11164033|NCT01961362|BG000|Baseline|Pulmonary Fibrosis Patients|Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis). We enrolled patients with PF not using supplemental O2 and then followed them forward until they were prescribed supplemental O2 by their treating practitioner, and then we followed them for an additional 12 months after being prescribed O2.
11164034|NCT01961362|FG000|Participant Flow|Pulmonary Fibrosis Patients|Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)
11164035|NCT01961362|OG000|Outcome|Pulmonary Fibrosis Patients|Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)
11164036|NCT01961362|EG000|Reported Event|Pulmonary Fibrosis Patients|Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)
11164037|NCT01961544|BG000|Baseline|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
11164038|NCT01961544|FG000|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
11164039|NCT01961544|OG000|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
11164040|NCT01961544|EG000|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2-5 minutes on Day 1 and Day 8 of each 21-day cycle.
11164041|NCT01961609|BG000|Baseline|Secukinumab (AIN457) 300 mg|Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
11164042|NCT01961609|BG001|Baseline|Secukinumab (AIN457) 150 mg|Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
11164043|NCT01961609|BG002|Baseline|Total|Total of all reporting groups
11342298|NCT03704376|OG000|Outcome|Femoral Nerve Blockade|"Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.~30 ml of 0.2% ropivacaine~100 mcg clonidine~High-frequency linear ultrasound transducer"
11233895|NCT02431468|FG001|Participant Flow|Bryostatin 1 40ug|"Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11164044|NCT01961609|FG000|Participant Flow|Secukinumab (AIN457) 300 mg|Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
11164045|NCT01961609|FG001|Participant Flow|Secukinumab (AIN457) 150 mg|Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
11164046|NCT01961609|FG002|Participant Flow|Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1)|Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16.
11164047|NCT01961609|FG003|Participant Flow|Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2)|Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48.
11164048|NCT01961609|OG000|Outcome|Secukinumab (AIN457) 300 mg|Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
11164049|NCT01961609|OG000|Outcome|Secukinumab (AIN457) 150 mg|Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
11164050|NCT01961609|OG000|Outcome|Secukinumab (AIN457) 300 mg Subgroup 1|Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
11164051|NCT01961609|OG001|Outcome|Secukinumab (AIN457) 300 mg Subgroup 2|Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
11164052|NCT01961609|OG002|Outcome|Secukinumab (AIN457) 300 mg Subgroup 3|All participants who have tried and failed more than one anti-TNFalpha therapies
11164053|NCT01961609|OG003|Outcome|Secukinumab (AIN457) 150 mg Subgroup 1|Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
11164054|NCT01961609|OG004|Outcome|Secukinumab (AIN457) 150 mg Subgroup 2|Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
11164055|NCT01961609|OG005|Outcome|Secukinumab (AIN457) 150 mg Subgroup 3|All participants who have tried and failed more than one anti-TNFalpha therapies
11164056|NCT01961609|OG001|Outcome|Secukinumab (AIN457) 150 mg|Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
11164057|NCT01961609|OG002|Outcome|Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1)|Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16.
11164058|NCT01961609|OG003|Outcome|Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2)|Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48.
11164059|NCT01961609|OG000|Outcome|Secukinumab (AIN457A) 300 mg Subgroups 1 and 2 Combined)|Participants who experienced an IR after trying first anti-TNFalpha therapy and participants who had initially experienced an adequate response after trying the first anti-TNFalpha therapy but then had subsequently lost that response.
11164060|NCT01961609|OG001|Outcome|Secukinumab (AIN457) 150 mg Subgroups 1 and 2|Participants who experienced an IR after trying first anti-TNFalpha therapy and participants who had initially experienced an adequate response after trying the first anti-TNFalpha therapy but then had subsequently lost that response.
11164061|NCT01961609|EG000|Reported Event|Secukinumab (AIN457) 150mg|Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
11164062|NCT01961609|EG001|Reported Event|Secukinumab (AIN457) 300mg|Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
11164063|NCT01961687|BG000|Baseline|Phasix Mesh|Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
11164064|NCT01961687|FG000|Participant Flow|Phasix Mesh Group|Patients requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
11164065|NCT01961687|OG000|Outcome|Phasix Mesh|Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
11164066|NCT01961687|EG000|Reported Event|Phasix Mesh|Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
11164067|NCT01961882|BG000|Baseline|OCV-501|3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
11164068|NCT01961882|BG001|Baseline|Placebo|Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
11164069|NCT01961882|BG002|Baseline|Total|Total of all reporting groups
11164070|NCT01961882|FG000|Participant Flow|OCV-501|3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
11164071|NCT01961882|FG001|Participant Flow|Placebo|Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
11164072|NCT01961882|OG000|Outcome|OCV-501|3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
11164073|NCT01961882|OG001|Outcome|Placebo|Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
11164074|NCT01961882|EG000|Reported Event|OCV-501|3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
11164075|NCT01961882|EG001|Reported Event|Placebo|Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
11164076|NCT01961921|BG000|Baseline|ALN-TTR02 (Patisiran)|Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
11164077|NCT01961921|FG000|Participant Flow|ALN-TTR02 (Patisiran)|Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
11164078|NCT01961921|OG000|Outcome|ALN-TTR02 (Patisiran)|Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
11164079|NCT01961921|EG000|Reported Event|Safety Population|All patients who received at least one dose of ALN-TTR02 (patisiran)
11164080|NCT01962025|BG000|Baseline|Buttonhole Needling Technique|"The intervention is the Buttonhole needling technique for home hemodialysis.~Buttonhole needling technique: the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation.~In the buttonhole technique, a constant site is used for needle placement that ultimately results in a fibrous tract. Once the tract has formed blunt needles can be used instead of sharp needles for each treatment. The presence of a tract may simplify the needle insertion technique and lead to enhanced patient confidence with needle placement."
11164081|NCT01962025|BG001|Baseline|Step Ladder Group|Patients will use step ladder needling technique (i.e., sites will be rotated with needles placed at least 2-3 cms between needle tips).
11164082|NCT01962025|BG002|Baseline|Total|Total of all reporting groups
11164083|NCT01962025|FG000|Participant Flow|Buttonhole Needling Technique|"The intervention is the Buttonhole needling technique for home hemodialysis~Buttonhole needling technique: the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation~In the buttonhole technique, a constant site is used for needle placement that ultimately results in a fibrous tract. Once the tract has formed blunt needles can be used instead of sharp needles for each treatment. The presence of a tract may simplify the needle insertion technique and lead to enhanced patient confidence with needle placement."
11164084|NCT01962025|FG001|Participant Flow|Step Ladder Group|Patients will use step ladder needling technique (i.e., sites will be rotated with needles placed at least 2-3cms between needle tips).
11164085|NCT01962025|OG000|Outcome|Buttonhole Needling Technique|"the intervention is the Buttonhole needling technique for home hemodialysis~Buttonhole needling technique: the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation"
11164086|NCT01962025|OG001|Outcome|Step Ladder Group|Patients will use step ladder needling technique
11164087|NCT01962025|OG000|Outcome|Buttonhole Needling Technique|"The intervention is the Buttonhole needling technique for home hemodialysis~Buttonhole needling technique: the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation~In the buttonhole technique, a constant site is used for needle placement that ultimately results in a fibrous tract. Once the tract has formed blunt needles can be used instead of sharp needles for each treatment. The presence of a tract may simplify the needle insertion technique and lead to enhanced patient confidence with needle placement."
11164088|NCT01962025|OG001|Outcome|Step Ladder Group|Patients will use step ladder needling technique (i.e., sites will be rotated with needles placed at least 2-3cms between needle tips).
11164089|NCT01962025|EG000|Reported Event|Buttonhole Needling Technique|"the intervention is the Buttonhole needling technique for home hemodialysis~Buttonhole needling technique: the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation"
11164090|NCT01962025|EG001|Reported Event|Step Ladder Group|Patients will use step ladder needling technique
11164091|NCT01962103|BG000|Baseline|Phase 1: Nab-Paclitaxel 120 mg/m^2|nab-paclitaxel 120 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164092|NCT01962103|BG001|Baseline|Phase 1: Nab-Paclitaxel 150 mg/m^2|nab-paclitaxel 150 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164093|NCT01962103|BG002|Baseline|Phase 1: Nab-Paclitaxel 180 mg/m^2|nab-paclitaxel 180 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164094|NCT01962103|BG003|Baseline|Phase 1: Nab-Paclitaxel 210 mg/m^2|nab-paclitaxel 210 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164095|NCT01962103|BG004|Baseline|Phase 1: Nab-Paclitaxel 240 mg/m^2|nab-paclitaxel 240 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164096|NCT01962103|BG005|Baseline|Phase 1: Nab-Paclitaxel 270 mg/m^2|nab-paclitaxel 270 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164097|NCT01962103|BG006|Baseline|Phase 2: Ewing's Sarcoma|Participants with Ewing's sarcoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164098|NCT01962103|BG007|Baseline|Phase 2: Neuroblastoma|Participants with neuroblastoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164099|NCT01962103|BG008|Baseline|Phase 2: Rhabdomyosarcoma|Participants with rhabdomyosarcoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164100|NCT01962103|BG009|Baseline|Total|Total of all reporting groups
11164101|NCT01962103|FG000|Participant Flow|Phase 1: Nab-Paclitaxel 120 mg/m^2|nab-paclitaxel 120 mg/m^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
11164102|NCT01962103|FG001|Participant Flow|Phase 1: Nab-Paclitaxel 150 mg/m^2|nab-paclitaxel 150 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164103|NCT01962103|FG002|Participant Flow|Phase 1: Nab-Paclitaxel 180 mg/m^2|nab-paclitaxel 180 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164104|NCT01962103|FG003|Participant Flow|Phase 1: Nab-Paclitaxel 210 mg/m^2|nab-paclitaxel 210 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164105|NCT01962103|FG004|Participant Flow|Phase 1: Nab-Paclitaxel 240 mg/m^2|nab-paclitaxel 240 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164106|NCT01962103|FG005|Participant Flow|Phase 1: Nab-Paclitaxel 270 mg/m^2|nab-paclitaxel 270 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164107|NCT01962103|FG006|Participant Flow|Phase 2: Ewing's Sarcoma|Participants with Ewing's sarcoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11233896|NCT02431468|FG002|Participant Flow|Placebo|"Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution."
11164108|NCT01962103|FG007|Participant Flow|Phase 2: Neuroblastoma|Participants with neuroblastoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164109|NCT01962103|FG008|Participant Flow|Phase 2: Rhabdomyosarcoma|Participants with rhabdomyosarcoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164110|NCT01962103|OG000|Outcome|Phase 1: Nab-Paclitaxel 120 mg/m^2|nab-paclitaxel 120 mg/m^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
11164111|NCT01962103|OG001|Outcome|Phase 1: Nab-Paclitaxel 150 mg/m^2|nab-paclitaxel 150 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164112|NCT01962103|OG002|Outcome|Phase 1: Nab-Paclitaxel 180 mg/m^2|nab-paclitaxel 180 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164113|NCT01962103|OG003|Outcome|Phase 1: Nab-Paclitaxel 210 mg/m^2|nab-paclitaxel 210 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164114|NCT01962103|OG004|Outcome|Phase 1: Nab-Paclitaxel 240 mg/m^2|nab-paclitaxel 240 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164115|NCT01962103|OG005|Outcome|Phase 1: Nab-Paclitaxel 270 mg/m^2|nab-paclitaxel 270 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164116|NCT01962103|OG000|Outcome|Phase 2: Ewing's Sarcoma|Participants with Ewing's sarcoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164117|NCT01962103|OG001|Outcome|Phase 2: Neuroblastoma|Participants with neuroblastoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164118|NCT01962103|OG002|Outcome|Phase 2: Rhabdomyosarcoma|Participants with rhabdomyosarcoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164119|NCT01962103|OG000|Outcome|PK Population|Phase 1: nab-paclitaxel 120-270 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D. Phase 2: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164120|NCT01962103|OG000|Outcome|PK Population|The PK population included all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.
11164121|NCT01962103|EG000|Reported Event|Phase 1: Nab-Paclitaxel 120 mg/m^2|nab-paclitaxel 120 mg/m^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
11164122|NCT01962103|EG001|Reported Event|Phase 1: Nab-Paclitaxel 150 mg/m^2|nab-paclitaxel 150 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164123|NCT01962103|EG002|Reported Event|Phase 1: Nab-Paclitaxel 180 mg/m^2|nab-paclitaxel 180 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164124|NCT01962103|EG003|Reported Event|Phase 1: Nab-Paclitaxel 210 mg/m^2|nab-paclitaxel 210 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164125|NCT01962103|EG004|Reported Event|Phase 1: Nab-Paclitaxel 240 mg/m^2|nab-paclitaxel 240 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164126|NCT01962103|EG005|Reported Event|Phase 1: Nab-Paclitaxel 270 mg/m^2|nab-paclitaxel 270 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
11164127|NCT01962103|EG006|Reported Event|Phase 2: Nab-Paclitaxel 240 mg/m^2|Participants with Ewing's sarcoma, neuroblastoma, or rhabdomyosarcoma: nab-paclitaxel at the RP2D (240 mg/m^2 in participants weighing > 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
11164128|NCT01962207|BG000|Baseline|MenACWY-TT Vaccine: Less Than (<) 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11228227|NCT02388932|BG000|Baseline|Treatment (SBRT)|"Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days.~Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe.~The dosing strategy for the 2nd (45Gy) cohort will be identical to the first."
11228228|NCT02388932|FG000|Participant Flow|Treatment (SBRT)|"Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days.~Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe.~The dosing strategy for the 2nd (45Gy) cohort will be identical to the first."
11228229|NCT02388932|OG000|Outcome|Treatment (SBRT)|"Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days.~Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 patients allocated to them. All patients are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 patient experiences a DLT, patients will be enrolled at the next dose level. If ≥3 patients experience a DLT, further accrual will be permanently halted and the study stopped. If 2 patients experience a DLT, then an additional 6 patients will be enrolled at the same dose level. In this setting, if ≤ 3/12 patients have a DLT, patients will be enrolled at the next dose level. If ≥ 4/12 patients have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe.~The dosing strategy for the 2nd (45Gy) cohort will be identical to the first."
11228230|NCT02388932|OG000|Outcome|Treatment (SBRT)|"Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days.~Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe.~The dosing strategy for the 2nd (45Gy) cohort will be identical to the first."
11228231|NCT02388932|EG000|Reported Event|Treatment (SBRT)|"Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days.~Stereotactic Body Radiation Therapy: Undergo SBRT~Positron Emission Tomography: Undergo PET/CT~Computed Tomography: Undergo PET/CT~Quality-of-Life Assessment: Ancillary studies"
11228232|NCT02388997|BG000|Baseline|Mild Asthmatics Treated With Omalizumab|"Subjects with mild asthma will be treated with omalizumab for 8 weeks before and for 3 weeks after an experimental challenge with rhinovirus. Omalizumab will be given subcutaneously every 2 to 4 weeks according to the manufacturer's recommendations.~omalizumab: This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)~Rhinovirus (strain 16): This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA."
11228233|NCT02388997|BG001|Baseline|Mild Asthmatics Treated With Placebo Medication|"Subjects with mild asthma will be treated with placebo medication for 8 weeks before and for 3 weeks after an experimental challenge with rhinovirus. The placebo mediation will consist of the same diluent used for suspending the omalizumab without omalizumab added.~omalizumab: This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)~Rhinovirus (strain 16): This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA."
11228234|NCT02388997|BG002|Baseline|Total|Total of all reporting groups
11228235|NCT02388997|FG000|Participant Flow|Mild Asthmatics Treated With Omalizumab|"Subjects with mild asthma will be treated with omalizumab for 8 weeks before and for 3 weeks after an experimental challenge with rhinovirus. Omalizumab will be given subcutaneously every 2 to 4 weeks according to the manufacturer's recommendations.~omalizumab: This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)~Rhinovirus (strain 16): This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA."
11228236|NCT02388997|FG001|Participant Flow|Mild Asthmatics Treated With Placebo Medication|"Subjects with mild asthma will be treated with placebo medication for 8 weeks before and for 3 weeks after an experimental challenge with rhinovirus. The placebo mediation will consist of the same diluent used for suspending the omalizumab without omalizumab added.~omalizumab: This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)~Rhinovirus (strain 16): This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA."
11164129|NCT01962207|BG001|Baseline|MenCCRM (Meningitec) Vaccine: Less Than 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164130|NCT01962207|BG002|Baseline|MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164131|NCT01962207|BG003|Baseline|MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164132|NCT01962207|BG004|Baseline|Total|Total of all reporting groups
11164133|NCT01962207|FG000|Participant Flow|MenACWY-TT Vaccine: Less Than (<) 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164134|NCT01962207|FG001|Participant Flow|MenCCRM (Meningitec) Vaccine: Less Than 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164135|NCT01962207|FG002|Participant Flow|MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164136|NCT01962207|FG003|Participant Flow|MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164137|NCT01962207|OG000|Outcome|MenACWY-TT Vaccine: Less Than (<) 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164138|NCT01962207|OG001|Outcome|MenCCRM (Meningitec) Vaccine: Less Than 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164139|NCT01962207|OG002|Outcome|MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11228237|NCT02388997|OG000|Outcome|Mild Asthmatics Treated With Omalizumab|"Subjects with mild asthma will be treated with omalizumab for 8 weeks before and for 3 weeks after an experimental challenge with rhinovirus. Omalizumab will be given subcutaneously every 2 to 4 weeks according to the manufacturer's recommendations.~omalizumab: This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)~Rhinovirus (strain 16): This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA."
11228238|NCT02388997|OG001|Outcome|Mild Asthmatics Treated With Placebo Medication|"Subjects with mild asthma will be treated with placebo medication for 8 weeks before and for 3 weeks after an experimental challenge with rhinovirus. The placebo mediation will consist of the same diluent used for suspending the omalizumab without omalizumab added.~omalizumab: This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)~Rhinovirus (strain 16): This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA."
11228239|NCT02388997|EG000|Reported Event|Mild Asthmatics Treated With Omalizumab|"Subjects with mild asthma will be treated with omalizumab for 8 weeks before and for 3 weeks after an experimental challenge with rhinovirus. Omalizumab will be given subcutaneously every 2 to 4 weeks according to the manufacturer's recommendations.~omalizumab: This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)~Rhinovirus (strain 16): This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA."
11228240|NCT02388997|EG001|Reported Event|Mild Asthmatics Treated With Placebo Medication|"Subjects with mild asthma will be treated with placebo medication for 8 weeks before and for 3 weeks after an experimental challenge with rhinovirus. The placebo mediation will consist of the same diluent used for suspending the omalizumab without omalizumab added.~omalizumab: This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)~Rhinovirus (strain 16): This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA."
11228241|NCT02389088|BG000|Baseline|Phase I|9 PCOS women
11228242|NCT02389088|FG000|Participant Flow|Phase I - All Study Participants|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.~The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
11228243|NCT02389088|OG000|Outcome|Phase I - Week 0 - 24 Hours|
11228244|NCT02389088|OG001|Outcome|Phase I - Week 5 - 0 Hour|
11228245|NCT02389088|OG002|Outcome|Phase I - Week 5 - 24 Hour|
11228246|NCT02389088|OG003|Outcome|Phase I - Week 6 - 0 Hour|
11228247|NCT02389088|OG004|Outcome|Phase I - Week 6 - 24 Hour|
11228248|NCT02389088|OG005|Outcome|Phase II - Week 0 - 24 Hours|
11228249|NCT02389088|OG006|Outcome|Phase II - Week 5 - 0 Hours|
11228250|NCT02389088|OG007|Outcome|Phase II - Week 5 - 24 Hours|
11228251|NCT02389088|OG008|Outcome|Phase II - Week 6 - 0 Hours|
11228252|NCT02389088|OG009|Outcome|Phase II - Week 6 - 24 Hours|
11228253|NCT02389088|EG000|Reported Event|Phase I|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.~The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
11228254|NCT02389088|EG001|Reported Event|Phase II|"Women that participated in Phase I will be studied again after a washout of 2 months. On study day one, an FSH stimulation test will be performed as described above.~After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month. Four weeks after administration of Lupron, each subject will receive Letrozole 5mg for 14 days. The FSH stimulation test will be repeated at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function).~Letrozole: In Phase II, letrozole, 5 mg/day, will be given for 14 days"
11228255|NCT02389101|BG000|Baseline|Study Patients|Patiens with lymphoma
11228256|NCT02389101|FG000|Participant Flow|Lymphoma|68Ga-DOTANOC PET/CT; Diffusion weighted MRI: PET/CT: Radionuclide imaging using short-lived isotope Ga-68; MRI imaging w/o gadolinium contrast
11228257|NCT02389101|OG000|Outcome|Lymphoma|Uptake of 68Ga-DOTANOC
11228258|NCT02389101|EG000|Reported Event|Lymphoma|"Newly diagnosed lymphoma, all subtypes allowed~68Ga-DOTANOC PET/CT; Diffusion weighted MRI: PET/CT: Radionuclide imaging using short-lived isotope Ga-68; MRI imaging w/o gadolinium contrast"
11228259|NCT02389361|BG000|Baseline|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
11228260|NCT02389361|BG001|Baseline|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
11228261|NCT02389361|BG002|Baseline|Total|Total of all reporting groups
11228262|NCT02389361|FG000|Participant Flow|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
11228263|NCT02389361|FG001|Participant Flow|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
11228264|NCT02389361|OG000|Outcome|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
11228265|NCT02389361|OG001|Outcome|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
11228266|NCT02389361|EG000|Reported Event|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
11164140|NCT01962207|OG003|Outcome|MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years|Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
11164141|NCT01962207|EG000|Reported Event|Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)|Participants with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
11164142|NCT01962207|EG001|Reported Event|Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)|Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
11164143|NCT01962207|EG002|Reported Event|Persistence Phase: MenACWY-TT Vaccine (>=2 Years)|Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
11164144|NCT01962207|EG003|Reported Event|Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)|Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
11164145|NCT01962207|EG004|Reported Event|Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)|Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months.
11164146|NCT01962207|EG005|Reported Event|Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)|Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months.
11164147|NCT01962207|EG006|Reported Event|Booster Phase: MenACWY-TT Vaccine (>= 2 Years)|Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months.
11164148|NCT01962207|EG007|Reported Event|Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)|Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months.
11164149|NCT01962298|BG000|Baseline|Single Rocuronium Dose - Placebo|"The patients will receive a single rocuronium dose, and no reversal agent.~placebo~Single rocuronium dose"
11164150|NCT01962298|BG001|Baseline|Single Rocuronium Dose - Sugammadex|"The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent~sugammadex 2mg/kg~Single rocuronium dose"
11164151|NCT01962298|BG002|Baseline|Repeated Rocuronium Dose - Neostigmine|"The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent~neostigmine~Repeated rocuronium dose"
11164152|NCT01962298|BG003|Baseline|Repeated Rocuronium Dose - Sugammadex|"The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent~sugammadex 2mg/kg~Repeated rocuronium dose"
11164153|NCT01962298|BG004|Baseline|Continuous Rocuronium Dose|"The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent~sugammadex 4mg/kg~Continuous rocuronium infusion"
11164154|NCT01962298|BG005|Baseline|Total|Total of all reporting groups
11164155|NCT01962298|FG000|Participant Flow|Single Rocuronium Dose - Placebo|"The patients will receive a single rocuronium dose, and no reversal agent.~placebo~Single rocuronium dose"
11164156|NCT01962298|FG001|Participant Flow|Single Rocuronium Dose - Sugammadex|"The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent~sugammadex 2mg/kg~Single rocuronium dose"
11164157|NCT01962298|FG002|Participant Flow|Repeated Rocuronium Dose - Neostigmine|"The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent~neostigmine~Repeated rocuronium dose"
11164158|NCT01962298|FG003|Participant Flow|Repeated Rocuronium Dose - Sugammadex|"The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent~sugammadex 2mg/kg~Repeated rocuronium dose"
11164159|NCT01962298|FG004|Participant Flow|Continuous Rocuronium Dose|"The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent~sugammadex 4mg/kg~Continuous rocuronium infusion"
11164160|NCT01962298|OG000|Outcome|Single Rocuronium Dose - Placebo|"The patients will receive a single rocuronium dose, and no reversal agent.~placebo~Single rocuronium dose"
11164161|NCT01962298|OG001|Outcome|Single Rocuronium Dose - Sugammadex|"The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent~sugammadex 2mg/kg~Single rocuronium dose"
11164162|NCT01962298|OG002|Outcome|Repeated Rocuronium Dose - Neostigmine|"The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent~neostigmine~Repeated rocuronium dose"
11164163|NCT01962298|OG003|Outcome|Repeated Rocuronium Dose - Sugammadex|"The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent~sugammadex 2mg/kg~Repeated rocuronium dose"
11164164|NCT01962298|OG004|Outcome|Continuous Rocuronium Dose|"The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent~sugammadex 4mg/kg~Continuous rocuronium infusion"
11164165|NCT01962298|EG000|Reported Event|Single Rocuronium Dose - Placebo|"The patients will receive a single rocuronium dose, and no reversal agent.~placebo~Single rocuronium dose"
11164166|NCT01962298|EG001|Reported Event|Single Rocuronium Dose - Sugammadex|"The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent~sugammadex 2mg/kg~Single rocuronium dose"
11164167|NCT01962298|EG002|Reported Event|Repeated Rocuronium Dose - Neostigmine|"The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent~neostigmine~Repeated rocuronium dose"
11164168|NCT01962298|EG003|Reported Event|Repeated Rocuronium Dose - Sugammadex|"The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent~sugammadex 2mg/kg~Repeated rocuronium dose"
11164169|NCT01962298|EG004|Reported Event|Continuous Rocuronium Dose|"The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent~sugammadex 4mg/kg~Continuous rocuronium infusion"
11164170|NCT01962428|BG000|Baseline|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
11164171|NCT01962428|BG001|Baseline|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
11164172|NCT01962428|BG002|Baseline|Total|Total of all reporting groups
11164173|NCT01962428|FG000|Participant Flow|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
11164174|NCT01962428|FG001|Participant Flow|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
11164175|NCT01962428|OG000|Outcome|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
11164176|NCT01962428|OG001|Outcome|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
11164177|NCT01962428|EG000|Reported Event|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
11164178|NCT01962428|EG001|Reported Event|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
11164179|NCT01962441|BG000|Baseline|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
11164180|NCT01962441|BG001|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
11164181|NCT01962441|BG002|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
11164182|NCT01962441|BG003|Baseline|Total|Total of all reporting groups
11164183|NCT01962441|FG000|Participant Flow|SOF+RBV 16 Weeks, Then Retreatment|"Randomized Period: Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks~Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks."
11164184|NCT01962441|FG001|Participant Flow|SOF+RBV 24 Weeks, Then Retreatment|"Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks~Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks."
11164185|NCT01962441|FG002|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|"Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks~Participants in this group were not eligible to enroll into the Retreatment Period."
11164186|NCT01962441|OG000|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
11164187|NCT01962441|OG001|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
11164188|NCT01962441|OG002|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
11164189|NCT01962441|EG000|Reported Event|Randomized Period: SOF+RBV 16 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
11164190|NCT01962441|EG001|Reported Event|Randomized Period: SOF+RBV 24 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
11164191|NCT01962441|EG002|Reported Event|Randomized Period: SOF+RBV+Peg-IFN 12 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
11164192|NCT01962441|EG003|Reported Event|Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks|Retreatment Period: Participants from the SOF+RBV 16 Weeks or 24 Weeks groups who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks.
11164193|NCT01962493|BG000|Baseline|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
11164194|NCT01962493|BG001|Baseline|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
11164195|NCT01962493|BG002|Baseline|Total|Total of all reporting groups
11164196|NCT01962493|FG000|Participant Flow|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
11164197|NCT01962493|FG001|Participant Flow|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
11164198|NCT01962493|OG000|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
11164199|NCT01962493|OG001|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
11164200|NCT01962493|EG000|Reported Event|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
11164201|NCT01962493|EG001|Reported Event|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
11164202|NCT01962558|BG000|Baseline|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
11164203|NCT01962558|BG001|Baseline|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
11164204|NCT01962558|BG002|Baseline|Total|Total of all reporting groups
11164205|NCT01962558|FG000|Participant Flow|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
11228267|NCT02389361|EG001|Reported Event|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
11164206|NCT01962558|FG001|Participant Flow|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
11164207|NCT01962558|OG000|Outcome|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
11164208|NCT01962558|OG001|Outcome|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
11164209|NCT01962558|EG000|Reported Event|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
11164210|NCT01962558|EG001|Reported Event|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
11164211|NCT01962688|BG000|Baseline|Handheld Ultrasound|Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
11164212|NCT01962688|BG001|Baseline|Clinical Assessment Only|Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
11164213|NCT01962688|BG002|Baseline|Total|Total of all reporting groups
11164214|NCT01962688|FG000|Participant Flow|Handheld Ultrasound|Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
11164215|NCT01962688|FG001|Participant Flow|Clinical Assessment Only|Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
11164216|NCT01962688|OG000|Outcome|Handheld Ultrasound|Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
11164217|NCT01962688|OG001|Outcome|Clinical Assessment Only|Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
11164218|NCT01962688|EG000|Reported Event|Handheld Ultrasound|Patients underwent clinical assessment with additional pocket ultrasound (VScan, GE Healthcare) guided assessment of inferior-vena cava for assessing volume status.
11164219|NCT01962688|EG001|Reported Event|Clinical Assessment Only|Patients underwent clinical assessment without additional pocket ultrasound guided assessment of inferior-vena cava for assessing volume status.
11164220|NCT01962714|BG000|Baseline|Loving-Kindness Meditation|The intervention consisted of 12 weekly 90-minute group sessions. In Loving-Kindness Meditation, a person sits and calls to mind a particular person (e.g., a good friend) and silently repeats phrases that invoke goodwill for that person, e.g., the desire for safety, happiness, health, and peace. Over 12 weeks, the practice expands to bring to mind other individuals or categories of people, including themselves, neutral persons, and those who have caused difficulty or harm, changing the phrases as needed. Participants are asked to notice any thoughts and feelings elicited by the phrases with an attitude of kindness, curiosity, and non-judgment, regardless of content. Each session begins with either mindfulness meditation (weeks 1 & 2) or LKM meditation (weeks 3 through 12) followed by group discussion and additional LKM teaching and practice. Homework for LKM consisted of 30 minutes of meditation 6 days per week using compact disks (CDs) as well as informal LKM practice in daily life.
11164221|NCT01962714|BG001|Baseline|Cognitive Processing Therapy - Cognitive Only|CPT-C does not include writing a trauma narrative. The intervention is based on Resick and colleagues' manual for treating PTSD among military veterans, which combines cognitive restructuring with emotional processing of trauma- related content. Sessions initially focus on rigid or inaccurate beliefs about the traumatic event itself, which often reflect self-blame or hindsight bias. Later sessions address over-generalized beliefs about self and others that result from a traumatic event relevant to five key areas: safety, trust, power, esteem, and intimacy. Clients learn to identify and modify their beliefs to develop more balanced, flexible, and ultimately, more adaptive beliefs. Homework for CPT-C consisted of 30 minutes of homework 6 days a week, including writing an impact statement at the beginning and the end of treatment and completing worksheets and exercises regarding safety, trust, power/control, esteem, and intimacy.
11164222|NCT01962714|BG002|Baseline|Total|Total of all reporting groups
11164223|NCT01962714|FG000|Participant Flow|Loving-Kindness Meditation|"A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.~Loving-Kindness Meditation: 12-week loving-kindness meditation course"
11164224|NCT01962714|FG001|Participant Flow|Cognitive Processing Therapy - Cognitive Only|"A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.~Cognitive Processing Therapy: 12-week CPT course"
11164225|NCT01962714|OG000|Outcome|Loving-Kindness Meditation|"A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.~Loving-Kindness Meditation: 12-week loving-kindness meditation course"
11164226|NCT01962714|OG001|Outcome|Cognitive Processing Therapy - Cognitive Only|"A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.~Cognitive Processing Therapy: 12-week CPT course"
11164227|NCT01962714|EG000|Reported Event|Loving-Kindness Meditation|A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.
11164228|NCT01962714|EG001|Reported Event|Cognitive Processing Therapy - Cognitive Only|A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.
11164229|NCT01962870|BG000|Baseline|Placebo|"Placebo Nasal Spray~Placebo"
11164230|NCT01962870|BG001|Baseline|Vasopressin|"Vasopressin Nasal Spray~Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily)."
11164231|NCT01962870|BG002|Baseline|Total|Total of all reporting groups
11164232|NCT01962870|FG000|Participant Flow|Placebo|"Placebo Nasal Spray~Placebo"
11164233|NCT01962870|FG001|Participant Flow|Vasopressin|"Vasopressin Nasal Spray~Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily)."
11164234|NCT01962870|OG000|Outcome|Placebo|"Placebo Nasal Spray~Placebo"
11164235|NCT01962870|OG001|Outcome|Vasopressin|"Vasopressin Nasal Spray~Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily)."
11164236|NCT01962870|EG000|Reported Event|Placebo|"Placebo Nasal Spray~Placebo"
11164237|NCT01962870|EG001|Reported Event|Vasopressin|"Vasopressin Nasal Spray~Vasopressin: Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily)."
11164238|NCT01962896|BG000|Baseline|Erlotinib + Sirolimus|"Erlotinib~Sirolimus"
11164239|NCT01962896|FG000|Participant Flow|Erlotinib + Sirolimus|"Erlotinib 85 mg/m2, max of 150 mg, was administered orally once daily continuously. Intrapatient dose escalation and de-escalation rules provided in the protocol.~Sirolimus was started at a dose of 1 mg/m2, maximum 2mg, orally once daily continuously. The dose of sirolimus was be adjusted at least weekly to obtain a goal trough level of 10-15ng/mL."
11164240|NCT01962896|OG000|Outcome|Erlotinib + Sirolimus|"Erlotinib~Sirolimus"
11164241|NCT01962896|OG000|Outcome|Erlotinib + Sirolimus|"Erlotinib 85 mg/m2, max of 150 mg, was administered orally once daily continuously. Intrapatient dose escalation and de-escalation rules provided in the protocol.~Sirolimus was started at a dose of 1 mg/m2, maximum 2mg, orally once daily continuously. The dose of sirolimus was be adjusted at least weekly to obtain a goal trough level of 10-15ng/mL."
11164242|NCT01962896|EG000|Reported Event|Erlotinib + Sirolimus|"Erlotinib~Sirolimus"
11164243|NCT01962922|BG000|Baseline|Sequence I|Sequence I IR-Tac→Envarsus XR (N = 27)
11164244|NCT01962922|BG001|Baseline|Sequence II|Sequence II Envarsus XR→IR-Tac (N = 23)
11164245|NCT01962922|BG002|Baseline|Total|Total of all reporting groups
11164246|NCT01962922|FG000|Participant Flow|Sequence 1|"•Sequence I: (n=27) Patients will continue on twice-daily IR-Tac capsules on Days 1-7 (24-hour PK profile on Day 7), then patients are switched to Envarsus XR tablets (at a dose 15% lower than their Tac - IR doses) on Day 8. PK on day 14 and 21.~Patients in sequence 1 are on Envarsus XR at Day 21. Patient may continue on extension up to a total of 6 months."
11164247|NCT01962922|FG001|Participant Flow|Sequence 2|"• Sequence II: (n=23) 1 Patients receive Envarsus XR tablets (at 15% lower dose than their IR-Tac dose) on Days 1-7 (24-hour PK profile on Day 7), then patients are switched back to twice-daily Tac - IR treatment beginning on Day 8. PK on days 14 and 21.~Patients in sequence 2 are on Tac - IR at Day 21. Patient have option of continuing in extension portion of the study on Tac - IR for up to 6 months."
11164248|NCT01962922|OG000|Outcome|Envarsus XR|Tacrolimus tablets once daily.
11164249|NCT01962922|OG001|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
11164250|NCT01962922|EG000|Reported Event|Envarsus XR|Tacrolimus extended release
11164251|NCT01962922|EG001|Reported Event|Tacrolimus - IR|brand IR tacrolimus
11174014|NCT02019277|BG000|Baseline|Trastuzumab, Pertuzumab, and Taxane|Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
11174015|NCT02019277|FG000|Participant Flow|Trastuzumab, Pertuzumab, and Taxane|Participants received first-line therapy with pertuzumab administered via intravenous (IV) infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 milligrams (mg), followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via subcutaneous (SC) injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until disease progression (PD), unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
11174325|NCT02020941|OG000|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
11228268|NCT02389452|BG000|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
11228269|NCT02389452|FG000|Participant Flow|Synvisc-One|Single 6 mL intra-articular (IA) injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52 ) when measured on a 0-100 mm scale, where higher score indicate higher pain.
11228270|NCT02389452|OG000|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
11228271|NCT02389452|EG000|Reported Event|Synvisc-One: Systemic Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.Systemic adverse events were defined as any adverse event which occurred anywhere other than in the treated joint.
11228272|NCT02389452|EG001|Reported Event|Synvisc-One: Local Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain. Local adverse events were defined as any adverse event which occurred in the treated joint.
11228273|NCT02389621|BG000|Baseline|Lusutrombopag|Lusutrombopag 3 mg once daily for up to 7 days.
11228274|NCT02389621|BG001|Baseline|Placebo|Placebo once daily for up to 7 days.
11228275|NCT02389621|BG002|Baseline|Total|Total of all reporting groups
11228276|NCT02389621|FG000|Participant Flow|Lusutrombopag|Lusutrombopag 3 mg once daily for up to 7 days.
11228277|NCT02389621|FG001|Participant Flow|Placebo|Placebo once daily for up to 7 days.
11228278|NCT02389621|OG000|Outcome|Lusutrombopag|Lusutrombopag 3 mg once daily for up to 7 days.
11228279|NCT02389621|OG001|Outcome|Placebo|Placebo once daily for up to 7 days.
11228280|NCT02389621|OG000|Outcome|Lusutrombopag With Platelet Transfusion|Lusutrombopag 3 mg once daily for up to 7 days in participants who received platelet transfusion.
11228281|NCT02389621|OG001|Outcome|Lusutrombopag Without Platelet Transfusion|Lusutrombopag 3 mg once daily for up to 7 days in participants who did not receive platelet transfusion.
11228282|NCT02389621|OG002|Outcome|Placebo With Platelet Transfusion|Placebo once daily for up to 7 days in participants who received platelet transfusion.
11228283|NCT02389621|OG003|Outcome|Placebo Without Platelet Transfusion|Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
11228284|NCT02389621|EG000|Reported Event|Lusutrombopag|Lusutrombopag 3 mg once daily for up to 7 days.
11228285|NCT02389621|EG001|Reported Event|Placebo|Placebo once daily for up to 7 days.
11228286|NCT02389725|BG000|Baseline|Disposable Elastic Tourniquet|disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
11228287|NCT02389725|BG001|Baseline|Manual Blood Pressure Cuff|manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
11228288|NCT02389725|BG002|Baseline|Total|Total of all reporting groups
11228289|NCT02389725|FG000|Participant Flow|Disposable Elastic Tourniquet|disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
11228290|NCT02389725|FG001|Participant Flow|Manual Blood Pressure Cuff|manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
11228291|NCT02389725|OG000|Outcome|Disposable Elastic Tourniquet|disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
11228292|NCT02389725|OG001|Outcome|Manual Blood Pressure Cuff|manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
11228293|NCT02389725|OG001|Outcome|Manual Blood Pressure Cuff|manual blood pressure cuff inflated to 150mm Hg
11228294|NCT02389725|OG001|Outcome|Manual Blood Pressure Cuff|"manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)~."
11228295|NCT02389725|EG000|Reported Event|Disposable Elastic Tourniquet|disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
11228296|NCT02389725|EG001|Reported Event|Manual Blood Pressure Cuff|manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
11228297|NCT02389738|BG000|Baseline|BBB Disruption With Regadenoson|"This is an exploratory (pilot) study to assess whether Regadenoson can disrupt the BBB, change the barrier permeability, to enhance the temozolomide delivery to brain.~Five evaluable patients will be studied in this trial. If the investigators detect ≥ 50% increase in temozolomide brain interstitium concentrations after Regadenoson, then the investigators will consider future studies evaluating additional patients.~Regadenoson: Regadenoson administration on post-op day 2 after temozolomide administration. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration.~Temozolomide: Temozolomide administration on post-op day 1 and 2. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration.~Microdialysis catheter: Microdialysis catheter placement post surgical resection and removed at the bedside after completion of obtaining all dialysate collections."
11228298|NCT02389738|FG000|Participant Flow|BBB Disruption With Regadenoson|"This is an exploratory (pilot) study to assess whether Regadenoson can disrupt the BBB, change the barrier permeability, to enhance the temozolomide delivery to brain.~Five evaluable patients will be studied in this trial. The sample size justification is not based on statistical rationale but clinical affordability. If the investigators detect ≥ 50% increase in temozolomide brain interstitium concentrations after Regadenoson, then the investigators will consider future studies evaluating additional patients.~Regadenoson: Regadenoson administration on post-op day 2 after temozolomide administration. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration.~Temozolomide: Temozolomide administration on post-op day 1 and 2. Microdialysis catheter: Microdialysis catheter placement post surgical resection Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration."
11228299|NCT02389738|OG000|Outcome|BBB Disruption With Regadenoson|"This is an exploratory (pilot) study to assess whether Regadenoson can disrupt the BBB, change the barrier permeability, to enhance the temozolomide delivery to brain.~Five evaluable patients will be studied in this trial. The sample size justification is not based on statistical rationale but clinical affordability. If the investigators detect ≥ 50% increase in temozolomide brain interstitium concentrations after Regadenoson, then the investigators will consider future studies evaluating additional patients.~Regadenoson: Regadenoson administration on post-op day 2 after temozolomide administration. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration.~Temozolomide: Temozolomide administration on post-op day 1 and 2. Microdialysis catheter: Microdialysis catheter placement post surgical resection. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration."
11228300|NCT02389738|EG000|Reported Event|BBB Disruption With Regadenoson|"This is an exploratory (pilot) study to assess whether Regadenoson can disrupt the BBB, change the barrier permeability, to enhance the temozolomide delivery to brain.~Five evaluable patients will be studied in this trial. The sample size justification is not based on statistical rationale but clinical affordability. If the investigators detect ≥ 50% increase in temozolomide brain interstitium concentrations after Regadenoson, then the investigators will consider future studies evaluating additional patients.~Regadenoson: Regadenoson administration on post-op day 2 after temozolomide administration.~Temozolomide: Temozolomide administration on post-op day 1 and 2.~Microdialysis catheter: Microdialysis catheter placement post surgical resection and removed at the bedside after completion of obtaining all dialysate collections obtained over 18 hours post temozolomde administration."
11228301|NCT02389764|BG000|Baseline|BIBF 1120|"Initial dose of BIBF 1120 is 200 mg twice daily orally for a 28 day cycle. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit.~BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.~Phone Call: Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. These calls should last about 2 minutes."
11228302|NCT02389764|FG000|Participant Flow|BIBF 1120|"Initial dose of BIBF 1120 is 200 mg twice daily orally for a 28 day cycle. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit.~BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.~Phone Call: Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. These calls should last about 2 minutes."
11228303|NCT02389764|OG000|Outcome|BIBF 1120|"Initial dose of BIBF 1120 is 200 mg twice daily orally for a 28 day cycle. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit.~BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.~Phone Call: Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. These calls should last about 2 minutes."
11228304|NCT02389764|EG000|Reported Event|BIBF 1120|"Initial dose of BIBF 1120 is 200 mg twice daily orally for a 28 day cycle. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit.~BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.~Phone Call: Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. These calls should last about 2 minutes."
11228305|NCT02389816|BG000|Baseline|Placebo|Placebo tablets, orally, once daily for up to Week 8
11228306|NCT02389816|BG001|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg tablets, orally, once daily for up to Week 8
11228307|NCT02389816|BG002|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg tablets, orally, once daily for up to Week 1, followed by vortioxetine 20 mg tablets, orally, once daily for up to Week 8
11228308|NCT02389816|BG003|Baseline|Total|Total of all reporting groups
11228309|NCT02389816|FG000|Participant Flow|Placebo|Placebo tablets, orally, once daily for up to Week 8
11228310|NCT02389816|FG001|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg tablets, orally, once daily for up to Week 8
11228311|NCT02389816|FG002|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg tablets, orally, once daily for up to Week 1, followed by vortioxetine 20 mg tablets, orally, once daily for up to Week 8
11228312|NCT02389816|OG000|Outcome|Placebo|Placebo tablets, orally, once daily for up to Week 8
11228313|NCT02389816|OG001|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg tablets, orally, once daily for up to Week 8
11228314|NCT02389816|OG002|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg tablets, orally, once daily for up to Week 1, followed by vortioxetine 20 mg tablets, orally, once daily for up to Week 8
11228315|NCT02389816|EG000|Reported Event|Placebo|Placebo tablets, orally, once daily for up to Week 8
11164252|NCT01962961|BG000|Baseline|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
11164253|NCT01962961|BG001|Baseline|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
11164254|NCT01962961|BG002|Baseline|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
11164255|NCT01962961|BG003|Baseline|Total|Total of all reporting groups
11164256|NCT01962961|FG000|Participant Flow|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
11164257|NCT01962961|FG001|Participant Flow|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
11164258|NCT01962961|FG002|Participant Flow|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
11164259|NCT01962961|OG000|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
11164260|NCT01962961|OG001|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
11164261|NCT01962961|OG002|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
11164262|NCT01962961|EG000|Reported Event|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
11228316|NCT02389816|EG001|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg tablets, orally, once daily for up to Week 8
11228317|NCT02389816|EG002|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg tablets, orally, once daily for up to Week 1, followed by vortioxetine 20 mg tablets, orally, once daily for up to Week 8
11228318|NCT02389829|BG000|Baseline|Hydromorphone|"Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.~Hydromorphone"
11228319|NCT02389829|BG001|Baseline|Prochlorperazine|"Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.~Patients can receive second 10mg dose at 1 hour.~Prochlorperazine~Diphenhydramine"
11228320|NCT02389829|BG002|Baseline|Total|Total of all reporting groups
11228321|NCT02389829|FG000|Participant Flow|Hydromorphone|"Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.~Hydromorphone"
11228322|NCT02389829|FG001|Participant Flow|Prochlorperazine|"Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.~Patients can receive second 10mg dose at 1 hour.~Prochlorperazine~Diphenhydramine"
11228323|NCT02389829|OG000|Outcome|Hydromorphone|"Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.~Hydromorphone"
11228324|NCT02389829|OG001|Outcome|Prochlorperazine|"Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.~Patients can receive second 10mg dose at 1 hour.~Prochlorperazine~Diphenhydramine"
11228325|NCT02389829|EG000|Reported Event|Hydromorphone|"Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.~Hydromorphone"
11228326|NCT02389829|EG001|Reported Event|Prochlorperazine|"Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.~Patients can receive second 10mg dose at 1 hour.~Prochlorperazine~Diphenhydramine"
11228327|NCT02389881|BG000|Baseline|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228328|NCT02389881|BG001|Baseline|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228329|NCT02389881|BG002|Baseline|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228330|NCT02389881|BG003|Baseline|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
11228331|NCT02389881|BG004|Baseline|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
11228332|NCT02389881|BG005|Baseline|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
11228333|NCT02389881|BG006|Baseline|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228334|NCT02389881|BG007|Baseline|Total|Total of all reporting groups
11228335|NCT02389881|FG000|Participant Flow|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228336|NCT02389881|FG001|Participant Flow|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228337|NCT02389881|FG002|Participant Flow|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228338|NCT02389881|FG003|Participant Flow|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
11228339|NCT02389881|FG004|Participant Flow|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
11228340|NCT02389881|FG005|Participant Flow|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
11228341|NCT02389881|FG006|Participant Flow|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228342|NCT02389881|OG000|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228343|NCT02389881|OG001|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228344|NCT02389881|OG002|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228345|NCT02389881|OG003|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
11228346|NCT02389881|OG004|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
11228347|NCT02389881|OG005|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
11228348|NCT02389881|OG006|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228349|NCT02389881|EG000|Reported Event|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228350|NCT02389881|EG001|Reported Event|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228351|NCT02389881|EG002|Reported Event|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11228352|NCT02389881|EG003|Reported Event|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
11164263|NCT01962961|EG001|Reported Event|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
11164264|NCT01962961|EG002|Reported Event|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
11164265|NCT01962987|BG000|Baseline|Diclofenac Sodium 3% Gel|"The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164266|NCT01962987|BG001|Baseline|Solaraze( Diclofenac Sodium) 3% Gel|"The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164267|NCT01962987|BG002|Baseline|Vehicle Gel|"The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164268|NCT01962987|BG003|Baseline|Total|Total of all reporting groups
11164269|NCT01962987|FG000|Participant Flow|Diclofenac Sodium 3% Gel|"The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164270|NCT01962987|FG001|Participant Flow|Solaraze( Diclofenac Sodium) 3% Gel|"The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164271|NCT01962987|FG002|Participant Flow|Vehicle Gel|"The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164272|NCT01962987|OG000|Outcome|Diclofenac Sodium 3% Gel|"The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164273|NCT01962987|OG001|Outcome|Solaraze( Diclofenac Sodium) 3% Gel|"The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164274|NCT01962987|OG002|Outcome|Vehicle Gel|"The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164275|NCT01962987|EG000|Reported Event|Diclofenac Sodium 3% Gel|"The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164276|NCT01962987|EG001|Reported Event|Solaraze( Diclofenac Sodium) 3% Gel|"The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164277|NCT01962987|EG002|Reported Event|Vehicle Gel|"The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.~Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days."
11164278|NCT01963078|BG000|Baseline|PTSD Placebo Day 1, Oxytocin Day 2|"Participants PTSD will self-administer matching placebo (containing all ingredients except OT) at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Placebo"
11164279|NCT01963078|BG001|Baseline|PTSD Oxytocin Day 1, Placebo Day 2|"Participants with PTSD will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Oxytocin"
11164280|NCT01963078|BG002|Baseline|Resilient Placebo Day 1, Oxytocin Day 2|"Resilient controls will self-administer matching placebo spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Placebo"
11164281|NCT01963078|BG003|Baseline|Resilient Oxytocin Day 1, Placebo Day 2|"Resilient controls will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Oxytocin"
11164282|NCT01963078|BG004|Baseline|Total|Total of all reporting groups
11164283|NCT01963078|FG000|Participant Flow|PTSD Placebo Day 1, Oxytocin Day 2|"Participants PTSD will self-administer matching placebo (containing all ingredients except OT) at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Placebo"
11164284|NCT01963078|FG001|Participant Flow|PTSD Oxytocin Day 1, Placebo Day 2|"Participants with PTSD will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Oxytocin"
11164285|NCT01963078|FG002|Participant Flow|Resilient Placebo Day 1, Oxytocin Day 2|"Resilient controls will self-administer matching placebo spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Placebo"
11164286|NCT01963078|FG003|Participant Flow|Resilient Oxytocin Day 1, Placebo Day 2|"Resilient controls will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Oxytocin"
11164287|NCT01963078|OG000|Outcome|PTSD Placebo Day 1, Oxytocin Day 2|"Participants PTSD will self-administer matching placebo (containing all ingredients except OT) at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Placebo"
11164288|NCT01963078|OG001|Outcome|PTSD Oxytocin Day 1, Placebo Day 2|"Participants with PTSD will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Oxytocin"
11164289|NCT01963078|OG002|Outcome|Resilient Placebo Day 1, Oxytocin Day 2|"Resilient controls will self-administer matching placebo spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Placebo"
11164290|NCT01963078|OG003|Outcome|Resilient Oxytocin Day 1, Placebo Day 2|"Resilient controls will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Oxytocin"
11164291|NCT01963078|EG000|Reported Event|PTSD Placebo|"Participants PTSD will self-administer matching placebo (containing all ingredients except OT) at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Placebo"
11164292|NCT01963078|EG001|Reported Event|PTSD Oxytocin|"Participants with PTSD will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Oxytocin"
11164293|NCT01963078|EG002|Reported Event|Resilient Placebo|"Resilient controls will self-administer matching placebo spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Placebo"
11164294|NCT01963078|EG003|Reported Event|Resilient Oxytocin|"Resilient controls will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).~Oxytocin"
11164295|NCT01963091|BG000|Baseline|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
11228353|NCT02389881|EG004|Reported Event|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
11164296|NCT01963091|BG001|Baseline|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
11164297|NCT01963091|BG002|Baseline|Total|Total of all reporting groups
11164298|NCT01963091|FG000|Participant Flow|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
11164299|NCT01963091|FG001|Participant Flow|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
11164300|NCT01963091|OG000|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
11164301|NCT01963091|OG001|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
11164302|NCT01963091|EG000|Reported Event|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
11164303|NCT01963091|EG001|Reported Event|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
11164304|NCT01963117|BG000|Baseline|CERT|Combination treatment with transarterial chemoembolization, radiotherapy, and hyperthermia
11164305|NCT01963117|FG000|Participant Flow|Combined Hypertermia and RT|Combined hyperthermia and radiation therapy
11164306|NCT01963117|OG000|Outcome|Combined Hypertermia and RT|Combined hyperthermia and radiation therapy
11164307|NCT01963117|EG000|Reported Event|Combined Hypertermia and RT|Combined hyperthermia and radiation therapy
11164308|NCT01963143|BG000|Baseline|Treatment Sequence 1 - Adults|Gammaplex 5% and Gammaplex 10 on a 21-day schedule
11164309|NCT01963143|BG001|Baseline|Treatment Sequence 2 - Adults|Gammaplex 5% and Gammaplex 10 on a 28-day schedule
11164310|NCT01963143|BG002|Baseline|Pediatrics|Gammaplex 10 on a 21 or 28 day schedule
11164311|NCT01963143|BG003|Baseline|Total|Total of all reporting groups
11164312|NCT01963143|FG000|Participant Flow|Treatment Sequence 1 - Adults|Gammaplex 5% & Gammaplex 10 on a 21-day treatment schedule
11164313|NCT01963143|FG001|Participant Flow|Treatment Sequence 2 - Adults|Gammaplex 10 and Gammaplex 5% on a 28-day treatment schedule
11164314|NCT01963143|FG002|Participant Flow|Pediatrics|Gammaplex 10 on a 21 or 28 day treatment schedule
11164315|NCT01963143|OG000|Outcome|Gammaplex 10%|
11164316|NCT01963143|OG001|Outcome|Gammaplex 5%|
11164317|NCT01963143|EG000|Reported Event|Gammaplex 5% - All Subjects|Subjects aged 17-55 years
11164318|NCT01963143|EG001|Reported Event|Gammaplex 10% - All Subjects|Subjects aged 2-55 years
11164319|NCT01963169|BG000|Baseline|TO-BoneHealth Group|The group will use the 8-week TO-BoneHealth program, which includes: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys.
11164320|NCT01963169|BG001|Baseline|TO-BoneHealth Plus Group|TO-BoneHealth Plus Program (Bone Power Plus Program): This intervention includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months.
11164321|NCT01963169|BG002|Baseline|Control Group|No specific intervention will be provided to the control group participants.
11164322|NCT01963169|BG003|Baseline|Total|Total of all reporting groups
11228354|NCT02389881|EG005|Reported Event|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
11164323|NCT01963169|FG000|Participant Flow|TO-BoneHealth Group|"The group will use the 8-week TO-BoneHealth program, which includes: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys.~TO-BoneHealth Program (Bone Power Program): The 8-week TO-BoneHealth program include: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment."
11164324|NCT01963169|FG001|Participant Flow|TO-BoneHealth Plus Group|"The group will use the TO-BoneHealth Plus program intervention, which includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months.~TO-BoneHealth Plus Program (Bone Power Plus Program): This intervention includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months."
11164325|NCT01963169|FG002|Participant Flow|Control Group|No specific intervention will be provided to the control group participants. To keep in contact with participants, a monthly e-mail will be sent to inform them of upcoming follow-up surveys. At the end of the study (upon completion of all five surveys), the control group participants will receive a CD version of the TO-BoneHealth program via mail.
11164326|NCT01963169|OG000|Outcome|TO-BoneHealth Group|"The group will use the 8-week TO-BoneHealth program, which includes: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys.~TO-BoneHealth Program (Bone Power Program): The 8-week TO-BoneHealth program include: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment."
11164327|NCT01963169|OG001|Outcome|TO-BoneHealth Plus Group|"The group will use the TO-BoneHealth Plus program intervention, which includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months.~TO-BoneHealth Plus Program (Bone Power Plus Program): This intervention includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months."
11164328|NCT01963169|OG002|Outcome|Control Group|No specific intervention will be provided to the control group participants. To keep in contact with participants, a monthly e-mail will be sent to inform them of upcoming follow-up surveys. At the end of the study (upon completion of all five surveys), the control group participants will receive a CD version of the TO-BoneHealth program via mail.
11164329|NCT01963169|EG000|Reported Event|TO-BoneHealth Group|"The group will use the 8-week TO-BoneHealth program, which includes: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys.~TO-BoneHealth Program (Bone Power Program): The 8-week TO-BoneHealth program include: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment."
11164330|NCT01963169|EG001|Reported Event|TO-BoneHealth Plus Group|"The group will use the TO-BoneHealth Plus program intervention, which includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months.~TO-BoneHealth Plus Program (Bone Power Plus Program): This intervention includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months."
11164331|NCT01963169|EG002|Reported Event|Control Group|No specific intervention will be provided to the control group participants. To keep in contact with participants, a monthly e-mail will be sent to inform them of upcoming follow-up surveys. At the end of the study (upon completion of all five surveys), the control group participants will receive a CD version of the TO-BoneHealth program via mail.
11164332|NCT01963234|BG000|Baseline|Seva - Madison Site|Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.
11164333|NCT01963234|BG001|Baseline|Seva - Missoula|Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.
11164334|NCT01963234|BG002|Baseline|Seva - Bronx|Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.
11164335|NCT01963234|BG003|Baseline|Total|Total of all reporting groups
11164336|NCT01963234|FG000|Participant Flow|Seva - Patients|Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.
11164337|NCT01963234|FG001|Participant Flow|Seva - Clinicians|We will analyze data of clinicians who use Seva (e.g. clinical adoption).
11164338|NCT01963234|OG000|Outcome|Seva - Madison Site|We identified 12 milestones for to meet for each site.
11164339|NCT01963234|OG001|Outcome|Seva - Missoula|We identified 12 milestones for to meet for each site.
11164340|NCT01963234|OG002|Outcome|Seva - Bronx|We identified 12 milestones for to meet for each site.
11164341|NCT01963234|OG000|Outcome|Seva|Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
11164342|NCT01963234|OG000|Outcome|Seva - Clinicians|This is the number of clinicians who work within clinics where Seva was implemented.
11164343|NCT01963234|OG000|Outcome|Seva - Madison Site|Patients will receive access to the Seva mobile health system for drug use disorders.
11164344|NCT01963234|OG001|Outcome|Seva - Missoula|Patients will receive access to the Seva mobile health system for drug use disorders.
11164345|NCT01963234|OG002|Outcome|Seva - Bronx|Patients will receive access to the Seva mobile health system for drug use disorders.
11164346|NCT01963234|EG000|Reported Event|Seva - Patients|Patients will receive access to the Seva mobile health system for drug use disorders.
11164347|NCT01963234|EG001|Reported Event|Seva - Clinicians|Clinicians who worked at Seva sites were also monitored for Adverse events.
11164348|NCT01963260|BG000|Baseline|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164349|NCT01963260|BG001|Baseline|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164350|NCT01963260|BG002|Baseline|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164351|NCT01963260|BG003|Baseline|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164352|NCT01963260|BG004|Baseline|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164353|NCT01963260|BG005|Baseline|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
11164354|NCT01963260|BG006|Baseline|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
11164355|NCT01963260|BG007|Baseline|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
11164356|NCT01963260|BG008|Baseline|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
11164357|NCT01963260|BG009|Baseline|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
11164358|NCT01963260|BG010|Baseline|Total|Total of all reporting groups
11164359|NCT01963260|FG000|Participant Flow|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164360|NCT01963260|FG001|Participant Flow|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164361|NCT01963260|FG002|Participant Flow|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164362|NCT01963260|FG003|Participant Flow|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164363|NCT01963260|FG004|Participant Flow|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164364|NCT01963260|FG005|Participant Flow|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
11164365|NCT01963260|FG006|Participant Flow|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with immune thrombocytopenia purpura (ITP) in Part 2. 2 participants were subsequently enrolled in Part 2 MK-8723 100 mg/kg.
11164366|NCT01963260|FG007|Participant Flow|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
11164367|NCT01963260|FG008|Participant Flow|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants with ITP from Part 2 MK-8723 10 mg/kg were re-enrolled into Part 2 100 mg/kg and dosed (not shown).
11164368|NCT01963260|FG009|Participant Flow|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
11164369|NCT01963260|OG000|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164370|NCT01963260|OG001|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164371|NCT01963260|OG002|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164372|NCT01963260|OG003|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164373|NCT01963260|OG004|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164374|NCT01963260|OG005|Outcome|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
11164375|NCT01963260|OG006|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
11164376|NCT01963260|OG007|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
11164377|NCT01963260|OG008|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
11164378|NCT01963260|OG009|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
11164379|NCT01963260|OG000|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
11164380|NCT01963260|OG001|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
11164381|NCT01963260|OG002|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
11164382|NCT01963260|OG003|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
11164383|NCT01963260|OG005|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
11164384|NCT01963260|OG006|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
11164385|NCT01963260|OG007|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
11164386|NCT01963260|EG000|Reported Event|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164387|NCT01963260|EG001|Reported Event|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164388|NCT01963260|EG002|Reported Event|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164389|NCT01963260|EG003|Reported Event|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164390|NCT01963260|EG004|Reported Event|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
11164391|NCT01963260|EG005|Reported Event|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
11164392|NCT01963260|EG006|Reported Event|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
11164393|NCT01963260|EG007|Reported Event|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
11164394|NCT01963260|EG008|Reported Event|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
11164395|NCT01963260|EG009|Reported Event|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
11164396|NCT01963403|BG000|Baseline|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
11164397|NCT01963403|BG001|Baseline|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
11164398|NCT01963403|BG002|Baseline|Total|Total of all reporting groups
11164399|NCT01963403|FG000|Participant Flow|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
11164400|NCT01963403|FG001|Participant Flow|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
11164401|NCT01963403|OG000|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
11164402|NCT01963403|OG001|Outcome|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
11164403|NCT01963403|OG000|Outcome|Used COC at Any Time During 3 Months|
11164404|NCT01963403|OG001|Outcome|No Use of COC at Any Time During 3 Months|
11164405|NCT01963403|EG000|Reported Event|EE 30mcg/LNG 150mcg|"Combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
11164406|NCT01963403|EG001|Reported Event|Placebo|Placebo: 1 pill per day; daily during study participation (up to 84 days)
11164407|NCT01963481|BG000|Baseline|Exemestane and Cyclophosphamide|"A treatment cycle is defined as 4 weeks:~One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events.~Exemestane~Cyclophosphamide"
11164408|NCT01963481|FG000|Participant Flow|Exemestane and Cyclophosphamide|"A treatment cycle is defined as 4 weeks:~One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events.~Exemestane~Cyclophosphamide"
11164409|NCT01963481|OG000|Outcome|Exemestane and Cyclophosphamide|"A treatment cycle is defined as 4 weeks:~One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events.~Exemestane~Cyclophosphamide"
11164410|NCT01963481|EG000|Reported Event|Exemestane and Cyclophosphamide|"A treatment cycle is defined as 4 weeks:~One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events.~Exemestane~Cyclophosphamide"
11164411|NCT01963611|BG000|Baseline|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164412|NCT01963611|BG001|Baseline|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164413|NCT01963611|BG002|Baseline|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164414|NCT01963611|BG003|Baseline|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
11164415|NCT01963611|BG004|Baseline|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
11164416|NCT01963611|BG005|Baseline|Total|Total of all reporting groups
11164417|NCT01963611|FG000|Participant Flow|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164418|NCT01963611|FG001|Participant Flow|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164419|NCT01963611|FG002|Participant Flow|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164420|NCT01963611|FG003|Participant Flow|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
11164421|NCT01963611|FG004|Participant Flow|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
11164422|NCT01963611|OG000|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164423|NCT01963611|OG001|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164424|NCT01963611|OG002|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
11164425|NCT01963611|OG003|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
11164426|NCT01963611|OG004|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
11164427|NCT01963611|OG004|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months
11164428|NCT01963611|EG000|Reported Event|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
11164429|NCT01963611|EG001|Reported Event|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
11164430|NCT01963611|EG002|Reported Event|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
11164431|NCT01963611|EG003|Reported Event|Plovamer Acetate 20 mg|Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.
11164432|NCT01963611|EG004|Reported Event|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
11164433|NCT01963676|BG000|Baseline|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
11164434|NCT01963676|BG001|Baseline|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
11164435|NCT01963676|BG002|Baseline|Total|Total of all reporting groups
11164436|NCT01963676|FG000|Participant Flow|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
11164437|NCT01963676|FG001|Participant Flow|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
11164438|NCT01963676|OG000|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
11164439|NCT01963676|OG001|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
11164440|NCT01963676|EG000|Reported Event|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
11164441|NCT01963676|EG001|Reported Event|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
11164442|NCT01963767|BG000|Baseline|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
11164443|NCT01963767|BG001|Baseline|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
11164444|NCT01963767|BG002|Baseline|Total|Total of all reporting groups
11164445|NCT01963767|FG000|Participant Flow|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
11164446|NCT01963767|FG001|Participant Flow|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
11228355|NCT02389881|EG006|Reported Event|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
11164447|NCT01963767|OG000|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
11164448|NCT01963767|OG001|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
11164449|NCT01963767|EG000|Reported Event|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
11164450|NCT01963767|EG001|Reported Event|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
11164451|NCT01963793|BG000|Baseline|Aprepitant Gel / Aprepitant Gel Vehicle|All 20 randomised participants were divided into two groups 1:1 10 with LEFT: aprepitant 10 mg/g gel and RIGHT: vehicle gel and 10 with LEFT: vehicle gel and RIGHT: aprepitant 10 mg/g gel
11164452|NCT01963793|FG000|Participant Flow|Aprepitant Gel / Aprepitant Gel Vehicle|Participants were treated with aprepitant on one extremity and vehicle gel on the other 1:1 thus acting as their own intra-individual controls 10 participants: LEFT: aprepitant 10 mg/g gel , RIGHT: vehicle gel and 10 participants: LEFT: vehicle gel RIGHT: aprepitant 10 mg/g gel
11164453|NCT01963793|OG000|Outcome|Aprepitant 10 mg/g Gel|20 participants treated with aprepitant 10mg/g gel on either left or right extremity
11164454|NCT01963793|OG001|Outcome|Aprepitant Gel Vehicle|20 participants were treated with vehicle gel on either left or right extremity
11164455|NCT01963793|OG000|Outcome|Aprepitant 10 mg/g Gel|20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
11164456|NCT01963793|OG000|Outcome|Lateral Side of Aprepitant 10 mg/g Gel|20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
11164457|NCT01963793|OG001|Outcome|Lateral Side of Aprepitant Gel Vehicle|20 participants were treated with vehicle gel on either left or right extremity
11164458|NCT01963793|OG000|Outcome|Evening: Aprepitant 10 mg/g Gel|20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
11164459|NCT01963793|OG001|Outcome|Evening: Aprepitant Gel Vehicle|20 participants were treated with vehicle gel on either left or right extremity
11164460|NCT01963793|OG002|Outcome|Morning: Aprepitant 10 mg/g Gel|20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
11164461|NCT01963793|OG003|Outcome|Morning: Aprepitant Gel Vehicle|20 participants were treated with vehicle gel on either left or right extremity
11164462|NCT01963793|OG000|Outcome|Evening: Aprepitant 10 mg/g Gel|20 participants were treated with vehicle gel on either left or right extremity
11164463|NCT01963793|EG000|Reported Event|Treatment Not Defined|The treatment for these adverse events are not defined
11164464|NCT01963793|EG001|Reported Event|Aprepitant Gel Vehicle|Placebo (Aprepitant gel vehicle)
11164465|NCT01963793|EG002|Reported Event|Aprepitant Gel|10 mg/g aprepitant gel
11164466|NCT01963845|BG000|Baseline|Placebo|Sitagliptin-matched placebo tablet
11164467|NCT01963845|BG001|Baseline|Active Drug|Sitagliptin 100 mg
11164468|NCT01963845|BG002|Baseline|Total|Total of all reporting groups
11164469|NCT01963845|FG000|Participant Flow|Placebo|Sitagliptin-matched placebo tablet
11164470|NCT01963845|FG001|Participant Flow|Active Drug|Sitagliptin 100 mg
11164471|NCT01963845|OG000|Outcome|Placebo|Sitagliptin-matched placebo tablet
11164472|NCT01963845|OG001|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
11164473|NCT01963845|EG000|Reported Event|Placebo|Sitagliptin-matched placebo tablet
11164474|NCT01963845|EG001|Reported Event|Active Drug|Sitagliptin 100 mg
11164475|NCT01963923|BG000|Baseline|Control Group|
11164476|NCT01963923|BG001|Baseline|Rehabilitation Group|
11164477|NCT01963923|BG002|Baseline|Total|Total of all reporting groups
11164478|NCT01963923|FG000|Participant Flow|Control Group|
11164479|NCT01963923|FG001|Participant Flow|Rehabilitation Group|
11164480|NCT01963923|OG000|Outcome|Rehabilitation Group|"The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program~Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device."
11164481|NCT01963923|OG001|Outcome|Control Group|The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
11164482|NCT01963923|OG000|Outcome|Control Group|"Number of curl-up repetitions performed in 30 in the control group"
11164483|NCT01963923|OG001|Outcome|Rehabilitation Group|"Number of curl-up repetitions performed in 30 in the rehabilitation group"
11164484|NCT01963923|OG000|Outcome|Control Group|"Number of curl-up repetitions performed in 30 in the control group 3 months post-surgery"
11164485|NCT01963923|OG001|Outcome|Rehabilitation Group|"Number of curl-up repetitions performed in 30 in the rehabilitation group 3 months post-surgery"
11164486|NCT01963923|OG000|Outcome|Control Group|"Number of sit-to-stand repetitions performed in 30 in the control group 3 weeks post-surgery"
11164487|NCT01963923|OG001|Outcome|Rehabilitation Group|"Number of sit-to-stand repetitions performed in 30 in the rehabilitation group 3 weeks post-surgery"
11164488|NCT01963923|OG000|Outcome|Control Group|"Number of sit-to-stand repetitions performed in 30 in the control group 3 months post-surgery"
11164489|NCT01963923|EG000|Reported Event|Rehabilitation Group|"The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program~Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device."
11164490|NCT01963923|EG001|Reported Event|Control Group|The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
11164491|NCT01964092|BG000|Baseline|Individual Placement and Support|"Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.~Individual Placement and Support"
11164492|NCT01964092|BG001|Baseline|Ordinary Employment Schemes|"The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.~Ordinary employment schemes"
11164493|NCT01964092|BG002|Baseline|Total|Total of all reporting groups
11164494|NCT01964092|FG000|Participant Flow|Individual Placement and Support|"Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.~Individual Placement and Support"
11164495|NCT01964092|FG001|Participant Flow|Ordinary Employment Schemes|"The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.~Ordinary employment schemes"
11164496|NCT01964092|OG000|Outcome|Individual Placement and Support|"Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.~Individual Placement and Support"
11164497|NCT01964092|OG001|Outcome|Ordinary Employment Schemes|"The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.~Ordinary employment schemes"
11164498|NCT01964092|EG000|Reported Event|Individual Placement and Support|"Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.~Individual Placement and Support"
11164499|NCT01964092|EG001|Reported Event|Ordinary Employment Schemes|"The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.~Ordinary employment schemes"
11164500|NCT01964105|BG000|Baseline|3D Imaging Simulation|The intervention group underwent computer simulation with the Vectra Sculptor package (Canfield Scientific Inc, Parsippany, NJ) in addition to control group preoperative evaluation.
11164501|NCT01964105|BG001|Baseline|Standard Preoperative Evaluation|The control group underwent tissue-based planning that was supplemented by review of photos obtained from magazines or the internet, and placement of sizers in a surgical bra. Control group patients underwent three-dimensional photography with the same system but were not simulated.
11164502|NCT01964105|BG002|Baseline|Non-Randomized Cohort: 3D Imaging|Since enrollment in the non-randomized arm was predicated upon a pre-existing desire for computer simulation, all of these patients received this intervention.
11164503|NCT01964105|BG003|Baseline|Total|Total of all reporting groups
11164504|NCT01964105|FG000|Participant Flow|Standard Preoperative Evaluation|"Control Group: Patients will receive standard preoperative evaluation (2D imaging).~Goal: 50 patients"
11164505|NCT01964105|FG001|Participant Flow|Non-Randomized Cohort: 3D Imaging|"Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort.~Goal: 50 Patients~3D Imaging"
11164506|NCT01964105|FG002|Participant Flow|3D Imaging Simulation|"Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients~3D Imaging"
11164507|NCT01964105|OG000|Outcome|Standard Preoperative Evaluation|"Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients~3D Imaging"
11164508|NCT01964105|OG001|Outcome|3D Imaging Simulation|"Control Group: Patients will receive standard preoperative evaluation (2D imaging).~Goal: 50 patients"
11164509|NCT01964105|OG002|Outcome|Non-Randomized Cohort: 3D Imaging|"Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort.~Goal: 50 Patients~3D Imaging"
11164510|NCT01964105|EG000|Reported Event|Standard Preoperative Evaluation|Patients undergo standard tissue-based planning. They were randomized to this intervention.
11164511|NCT01964105|EG001|Reported Event|3D Imaging Simulation|Patient undergo three-dimensional simulation of their breast augmentation. They were randomized to this intervention.
11164512|NCT01964105|EG002|Reported Event|Non-Randomized Cohort: 3D Imaging|Patient undergo three-dimensional simulation of their breast augmentation. They sought this intervention (ie. not randomized).
11164513|NCT01964222|BG000|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
11164514|NCT01964222|BG001|Baseline|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
11164515|NCT01964222|BG002|Baseline|Total|Total of all reporting groups
11164516|NCT01964222|FG000|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
11164517|NCT01964222|FG001|Participant Flow|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
11164518|NCT01964222|OG000|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
11164519|NCT01964222|OG001|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
11164520|NCT01964222|EG000|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
11164521|NCT01964222|EG001|Reported Event|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
11164522|NCT01964300|BG000|Baseline|Stratum 1|Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11164523|NCT01964300|BG001|Baseline|Stratum 2|Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11164524|NCT01964300|BG002|Baseline|Total|Total of all reporting groups
11164525|NCT01964300|FG000|Participant Flow|Stratum 1|Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11164526|NCT01964300|FG001|Participant Flow|Stratum 2|Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11164527|NCT01964300|OG000|Outcome|Stratum 1|Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11164528|NCT01964300|OG001|Outcome|Stratum 2|Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11164529|NCT01964300|EG000|Reported Event|Stratum 1|Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11164530|NCT01964300|EG001|Reported Event|Stratum 2|"Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Since the ineligible patient received 2 days of Peginterferon alfa-2b, that patient is included in all adverse event reporting results."
11164531|NCT01964326|BG000|Baseline|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
11164532|NCT01964326|FG000|Participant Flow|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
11164533|NCT01964326|OG000|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
11164534|NCT01964326|EG000|Reported Event|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
11164535|NCT01964352|BG000|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
11164536|NCT01964352|BG001|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
11164537|NCT01964352|BG002|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11164538|NCT01964352|BG003|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11164539|NCT01964352|BG004|Baseline|Total|Total of all reporting groups
11164540|NCT01964352|FG000|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
11164541|NCT01964352|FG001|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
11164542|NCT01964352|FG002|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11164543|NCT01964352|FG003|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11164544|NCT01964352|OG000|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
11228356|NCT02389894|BG000|Baseline|Embol-X Embolic Protection Device|"The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.~Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."
11228357|NCT02389894|BG001|Baseline|CardioGard Cannula|"The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.~CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."
11228358|NCT02389894|BG002|Baseline|Standard Cannula|Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
11228359|NCT02389894|BG003|Baseline|Total|Total of all reporting groups
11228360|NCT02389894|FG000|Participant Flow|Embol-X Embolic Protection Device|"The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.~Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."
11228361|NCT02389894|FG001|Participant Flow|CardioGard Cannula|"The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.~CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."
11228362|NCT02389894|FG002|Participant Flow|Standard Cannula|Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
11228363|NCT02389894|OG000|Outcome|Embol-X Embolic Protection Device|"The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.~Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."
11228364|NCT02389894|OG001|Outcome|CardioGard Cannula|"The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.~CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."
11228365|NCT02389894|OG002|Outcome|Standard Cannula|Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
11228366|NCT02389894|EG000|Reported Event|Embol-X Embolic Protection Device|"The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.~Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."
11228367|NCT02389894|EG001|Reported Event|CardioGard Cannula|"The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.~CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."
11228368|NCT02389894|EG002|Reported Event|Standard Cannula|Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
11228369|NCT02389959|BG000|Baseline|Bevacizumab|Bevacizumab mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL), injected into each side of the nose
11228370|NCT02389959|BG001|Baseline|Saline Control|Placebo (4mL of saline) mixed by the Stanford Hospital Pharmacy as a control.
11228371|NCT02389959|BG002|Baseline|Total|Total of all reporting groups
11228372|NCT02389959|FG000|Participant Flow|Bevacizumab|Bevacizumab mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL), injected into each side of the nose
11228373|NCT02389959|FG001|Participant Flow|Saline Control|Placebo (4mL of saline) mixed by the Stanford Hospital Pharmacy as a control.
11228374|NCT02389959|OG000|Outcome|Bevacizumab|Bevacizumab mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL), injected into each side of the nose
11228375|NCT02389959|OG001|Outcome|Saline Control|Placebo (4mL of saline) mixed by the Stanford Hospital Pharmacy as a control.
11228376|NCT02389959|EG000|Reported Event|Bevacizumab|Bevacizumab mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL), injected into each side of the nose.
11228377|NCT02389959|EG001|Reported Event|Saline Control|Placebo (4mL of saline) mixed by the Stanford Hospital Pharmacy as a control.
11228378|NCT02389998|BG000|Baseline|Placebo First Followed by no Treatment|"Arm 1: Subjects take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary for a period of three weeks. Subjects will also have access to hyoscyamine as a rescue medication.~Placebo Suspension: The study is divided into three phases: 1 one-week baseline assessment followed by 2 three-week study phases (phase A and phase B). Phase A will require subjects to take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary. In phase B subjects will not take the placebo. After 3 weeks in initial phase (either Phase A or B), subjects will switch to the alternate phase and continue the study for another 3 weeks. Hyoscyamine is available as a rescue medication during Phase A and Phase B. Half of the subjects will be randomized to begin with Phase A and half will be randomized to begin with Phase B.~Hyoscyamine: While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily."
11228379|NCT02389998|BG001|Baseline|No Treatment First Followed by Placebo|"Arm 2: Subjects receive no treatment but have access to hyoscyamine as a rescue medication.~Hyoscyamine: While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily."
11228380|NCT02389998|BG002|Baseline|Total|Total of all reporting groups
11228381|NCT02389998|FG000|Participant Flow|Placebo First Crossover to no Treatment After 3 Weeks|"Arm 1: Subjects take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary for a period of three weeks. Subjects will also have access to hyoscyamine as a rescue medication.~Placebo Suspension: The study is divided into three phases: 1 one-week baseline assessment followed by 2 three-week study phases (phase A and phase B). Phase A will require subjects to take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary. In phase B subjects will not take the placebo. After 3 weeks in initial phase (either Phase A or B), subjects will switch to the alternate phase and continue the study for another 3 weeks. Hyoscyamine is available as a rescue medication during Phase A and Phase B. Half of the subjects will be randomized to begin with Phase A and half will be randomized to begin with Phase B.~Hyoscyamine: While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily."
11164545|NCT01964352|OG001|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
11164546|NCT01964352|OG002|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11164547|NCT01964352|OG003|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11164548|NCT01964352|EG000|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
11164549|NCT01964352|EG001|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
11164550|NCT01964352|EG002|Reported Event|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11164551|NCT01964352|EG003|Reported Event|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11164552|NCT01964378|BG000|Baseline|Cebranopadol|"Once daily oral administration. 200, 400 or 600 µg film coated tablets. Dosage 200 µg to 1000 µg per day.~Cebranopadol: Participant will take one or two tablet(s) of cebranopadol in the morning and one or two placebo double-dummy morphine-like capsule(s) in the morning and the evening."
11164553|NCT01964378|BG001|Baseline|Morphine Prolonged Release|"Twice daily oral administration. 15, 30 or 45 mg morphine sulfate capsules. Dosage 30 to 150 mg per day.~Morphine Prolonged Release: Participant will take one or two morphine capsule(s) in the morning and in the evening and one or two placebo double-dummy cebranopadol-like tablet(s) in the morning."
11164554|NCT01964378|BG002|Baseline|Total|Total of all reporting groups
11164555|NCT01964378|FG000|Participant Flow|Cebranopadol|"Once daily oral administration. 200, 400 or 600 µg film coated tablets. Dosage 200 µg to 1000 µg per day.~Cebranopadol: Participant will take one or two tablet(s) of cebranopadol in the morning and one or two placebo double-dummy morphine-like capsule(s) in the morning and the evening."
11164556|NCT01964378|FG001|Participant Flow|Morphine Prolonged Release|"Twice daily oral administration. 15, 30 or 45 mg morphine sulfate capsules. Dosage 30 to 150 mg per day.~Morphine Prolonged Release: Participant will take one or two morphine capsule(s) in the morning and in the evening and one or two placebo double-dummy cebranopadol-like tablet(s) in the morning."
11164557|NCT01964378|OG000|Outcome|Cebranopadol|"Once daily oral administration. 200, 400 or 600 µg film coated tablets. Dosage 200 µg to 1000 µg per day.~Cebranopadol: Participant will take one or two tablet(s) of cebranopadol in the morning and one or two placebo double-dummy morphine-like capsule(s) in the morning and the evening."
11164558|NCT01964378|OG001|Outcome|Morphine Prolonged Release|"Twice daily oral administration. 15, 30 or 45 mg morphine sulfate capsules. Dosage 30 to 150 mg per day.~Morphine Prolonged Release: Participant will take one or two morphine capsule(s) in the morning and in the evening and one or two placebo double-dummy cebranopadol-like tablet(s) in the morning."
11164559|NCT01964378|EG000|Reported Event|Cebranopadol|"Once daily oral administration. 200, 400 or 600 µg film coated tablets. Dosage 200 µg to 1000 µg per day.~Cebranopadol: Participant will take one or two tablet(s) of cebranopadol in the morning and one or two placebo double-dummy morphine-like capsule(s) in the morning and the evening."
11164560|NCT01964378|EG001|Reported Event|Morphine Prolonged Release|"Twice daily oral administration. 15, 30 or 45 mg morphine sulfate capsules. Dosage 30 to 150 mg per day.~Morphine Prolonged Release: Participant will take one or two morphine capsule(s) in the morning and in the evening and one or two placebo double-dummy cebranopadol-like tablet(s) in the morning."
11164561|NCT01964430|BG000|Baseline|Nab-Paclitaxel and Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
11164562|NCT01964430|BG001|Baseline|Gemcitabine|Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
11164563|NCT01964430|BG002|Baseline|Total|Total of all reporting groups
11164564|NCT01964430|FG000|Participant Flow|Nab-Paclitaxel and Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
11164565|NCT01964430|FG001|Participant Flow|Gemcitabine|Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
11164566|NCT01964430|OG000|Outcome|Nab-Paclitaxel and Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
11164567|NCT01964430|OG001|Outcome|Gemcitabine|Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
11164568|NCT01964430|EG000|Reported Event|Nab-Paclitaxel/Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 administered as intravenous (IV) infusion over 30- to 40-minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30- to 40-minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
11228382|NCT02389998|FG001|Participant Flow|No Treatment First Crossover to Placebo After 3 Weeks|"Arm 2: Subjects receive no treatment but have access to hyoscyamine as a rescue medication.~Hyoscyamine: While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily."
11228383|NCT02389998|OG000|Outcome|Placebo|"Arm 1: Subjects take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary for a period of three weeks. Subjects will also have access to hyoscyamine as a rescue medication.~Placebo Suspension: The study is divided into three phases: 1 one-week baseline assessment followed by 2 three-week study phases (phase A and phase B). Phase A will require subjects to take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary. In phase B subjects will not take the placebo. After 3 weeks in initial phase (either Phase A or B), subjects will switch to the alternate phase and continue the study for another 3 weeks. Hyoscyamine is available as a rescue medication during Phase A and Phase B. Half of the subjects will be randomized to begin with Phase A and half will be randomized to begin with Phase B.~Hyoscyamine: While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily."
11228384|NCT02389998|OG001|Outcome|No Treatment|"Arm 2: Subjects receive no treatment but have access to hyoscyamine as a rescue medication.~Hyoscyamine: While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily."
11228385|NCT02389998|OG000|Outcome|Placebo|Patients during the placebo periods
11228386|NCT02389998|OG001|Outcome|No Treatment|Patients during the no treatment period
11228387|NCT02389998|EG000|Reported Event|Placebo|"Arm 1: Subjects take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary for a period of three weeks. Subjects will also have access to hyoscyamine as a rescue medication.~Placebo Suspension: The study is divided into three phases: 1 one-week baseline assessment followed by 2 three-week study phases (phase A and phase B). Phase A will require subjects to take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary. In phase B subjects will not take the placebo. After 3 weeks in initial phase (either Phase A or B), subjects will switch to the alternate phase and continue the study for another 3 weeks. Hyoscyamine is available as a rescue medication during Phase A and Phase B. Half of the subjects will be randomized to begin with Phase A and half will be randomized to begin with Phase B.~Hyoscyamine: While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily."
11228388|NCT02389998|EG001|Reported Event|No Treatment|"Arm 2: Subjects receive no treatment but have access to hyoscyamine as a rescue medication.~Hyoscyamine: While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily."
11228389|NCT02390050|BG000|Baseline|Placebo|"Placebo tablet once daily before breakfast~Placebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228390|NCT02390050|BG001|Baseline|Bexagliflozin 5 mg|"Bexagliflozin tablet, 5 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228391|NCT02390050|BG002|Baseline|Bexagliflozin 10 mg|"Bexagliflozin tablet, 10 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228392|NCT02390050|BG003|Baseline|Bexagliflozin 20 mg|"Bexagliflozin tablet, 20 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228393|NCT02390050|BG004|Baseline|Total|Total of all reporting groups
11228394|NCT02390050|FG000|Participant Flow|Placebo|"Placebo tablet once daily before breakfast~Placebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228395|NCT02390050|FG001|Participant Flow|Bexagliflozin 5 mg|"Bexagliflozin tablet, 5 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228396|NCT02390050|FG002|Participant Flow|Bexagliflozin 10 mg|"Bexagliflozin tablet, 10 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228397|NCT02390050|FG003|Participant Flow|Bexagliflozin 20 mg|"Bexagliflozin tablet, 20 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228398|NCT02390050|OG000|Outcome|Placebo|"Placebo tablet once daily before breakfast~Placebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228399|NCT02390050|OG001|Outcome|Bexagliflozin 5 mg|"Bexagliflozin tablet, 5 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228400|NCT02390050|OG002|Outcome|Bexagliflozin 10 mg|"Bexagliflozin tablet, 10 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228401|NCT02390050|OG003|Outcome|Bexagliflozin 20 mg|"Bexagliflozin tablet, 20 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228402|NCT02390050|EG000|Reported Event|Placebo|"Placebo tablet once daily before breakfast~Placebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228403|NCT02390050|EG001|Reported Event|Bexagliflozin 5 mg|"Bexagliflozin tablet, 5 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228404|NCT02390050|EG002|Reported Event|Bexagliflozin 10 mg|"Bexagliflozin tablet, 10 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11164569|NCT01964430|EG001|Reported Event|Gemcitabine|Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
11164570|NCT01964521|BG000|Baseline|Mepilex Transfer Ag|An open, non-comparative study.
11164571|NCT01964521|FG000|Participant Flow|Mepilex Transfer Ag|Mepilex Transfer Ag is a transfer dressing designed for low to high exuding wounds and used to prevent microbial growth. It is worn for up to two weeks at a time.
11164572|NCT01964521|OG000|Outcome|Mepilex Transfer Ag|An open, non-comparative study.
11164573|NCT01964521|OG000|Outcome|Pain by Visual Analogue Scale, LOCF|Levels of pain in connection to dressing changes.
11164574|NCT01964521|EG000|Reported Event|Mepilex Transfer Ag|An open, non-comparative study.
11164575|NCT01964547|BG000|Baseline|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
11164576|NCT01964547|BG001|Baseline|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
11164577|NCT01964547|BG002|Baseline|Total|Total of all reporting groups
11164578|NCT01964547|FG000|Participant Flow|Sativex|Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
11164579|NCT01964547|FG001|Participant Flow|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
11164580|NCT01964547|OG000|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
11164581|NCT01964547|OG001|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
11164582|NCT01964547|EG000|Reported Event|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
11164583|NCT01964547|EG001|Reported Event|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
11164584|NCT01964716|BG000|Baseline|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
11164585|NCT01964716|BG001|Baseline|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
11164586|NCT01964716|BG002|Baseline|Total|Total of all reporting groups
11164587|NCT01964716|FG000|Participant Flow|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
11164588|NCT01964716|FG001|Participant Flow|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
11164589|NCT01964716|OG000|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
11164590|NCT01964716|OG001|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
11164591|NCT01964716|OG002|Outcome|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
11164592|NCT01964716|EG000|Reported Event|13vPnC MDV: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
11164593|NCT01964716|EG001|Reported Event|13vPnC SDS: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
11164594|NCT01964716|EG002|Reported Event|13vPnC MDV: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
11164595|NCT01964716|EG003|Reported Event|13vPnC SDS: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
11164596|NCT01964716|EG004|Reported Event|13vPnC MDV: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
11164597|NCT01964716|EG005|Reported Event|13vPnC SDS: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
11164598|NCT01964716|EG006|Reported Event|13vPnC MDV: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
11164599|NCT01964716|EG007|Reported Event|13vPnC SDS: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
11164600|NCT01964716|EG008|Reported Event|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
11228405|NCT02390050|EG003|Reported Event|Bexagliflozin 20 mg|"Bexagliflozin tablet, 20 mg, once daily before breakfast~Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans."
11228406|NCT02390076|BG000|Baseline|Left Active LLLT|"Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy~Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer."
11228407|NCT02390076|BG001|Baseline|Right Active LLLT|"Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy~Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer."
11228408|NCT02390076|BG002|Baseline|Sham LLLT|"Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.~Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response."
11228409|NCT02390076|BG003|Baseline|Total|Total of all reporting groups
11228410|NCT02390076|FG000|Participant Flow|Left Active LLLT|"Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy~Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer."
11228411|NCT02390076|FG001|Participant Flow|Right Active LLLT|"Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy~Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer."
11228412|NCT02390076|FG002|Participant Flow|Sham LLLT|"Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.~Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response."
11233897|NCT02431468|OG000|Outcome|Bryostatin 1 20ug|"Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11164601|NCT01964755|BG000|Baseline|Chemotherapy + Antiviral-Based Therapy|"Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:~Chemotherapy: Up to 6 cycles, 21 days each:~Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;~Rituximab: 375mg/m2 (optional) IV on Day 1;~Methotrexate: 3.5 gm/m2 IV on Day 2;~Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;~Antiviral-Based Therapy~Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;~Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.~Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines~Methotrexate: Methotrexate administered starting on Day 2."
11164602|NCT01964755|FG000|Participant Flow|Chemotherapy + Antiviral-Based Therapy|"Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:~Chemotherapy: Up to 6 cycles, 21 days each:~Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;~Rituximab: 375mg/m2 (optional) IV on Day 1;~Methotrexate: 3.5 gm/m2 IV on Day 2;~Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;~Antiviral-Based Therapy~Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;~Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.~Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines~Methotrexate: Methotrexate administered starting on Day 2."
11164603|NCT01964755|OG000|Outcome|Chemotherapy + Antiviral-Based Therapy|"Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:~Chemotherapy: Up to 6 cycles, 21 days each:~Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;~Rituximab: 375mg/m2 (optional) IV on Day 1;~Methotrexate: 3.5 gm/m2 IV on Day 2;~Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;~Antiviral-Based Therapy~Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;~Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.~Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines~Methotrexate: Methotrexate administered starting on Day 2."
11164604|NCT01964755|EG000|Reported Event|Chemotherapy + Antiviral-Based Therapy|"Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:~Chemotherapy: Up to 6 cycles, 21 days each:~Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;~Rituximab: 375mg/m2 (optional) IV on Day 1;~Methotrexate: 3.5 gm/m2 IV on Day 2;~Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;~Antiviral-Based Therapy~Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;~Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.~Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines~Methotrexate: Methotrexate administered starting on Day 2."
11164605|NCT01964898|BG000|Baseline|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
11164606|NCT01964898|BG001|Baseline|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
11164607|NCT01964898|BG002|Baseline|Total|Total of all reporting groups
11164608|NCT01964898|FG000|Participant Flow|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
11164609|NCT01964898|FG001|Participant Flow|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
11233898|NCT02431468|OG001|Outcome|Bryostatin 1 40ug|"Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11164610|NCT01964898|OG000|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
11164611|NCT01964898|OG001|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
11164612|NCT01964898|EG000|Reported Event|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
11164613|NCT01964898|EG001|Reported Event|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
11164614|NCT01964924|BG000|Baseline|Treatment (Trametinib, Akt Inhibitor GSK2141795)|"PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.~PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor GSK2141795: Given PO~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
11164615|NCT01964924|FG000|Participant Flow|Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1:|PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression in Part 1 continue to Part 2.
11164616|NCT01964924|FG001|Participant Flow|Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:|"PART 2: Patients who experience disease progression in Part 1 continue to Part 2. Patients receive trametinib and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor GSK2141795: Given PO~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
11164617|NCT01964924|OG000|Outcome|Treatment (Trametinib, Akt Inhibitor GSK2141795)|"PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.~PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor GSK2141795: Given PO~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
11164618|NCT01964924|OG000|Outcome|Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1:|PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.
11164619|NCT01964924|OG001|Outcome|Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:|"PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor GSK2141795: Given PO~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
11164620|NCT01964924|OG001|Outcome|Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:|PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11164621|NCT01964924|OG001|Outcome|Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:|"PART 2: Patients who experience disease progression in Part 1 continue to Part 2. Patients receive trametinib and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor GSK2141795: Given PO~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
11164622|NCT01964924|EG000|Reported Event|Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1:|PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.
11164623|NCT01964924|EG001|Reported Event|Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:|PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11228413|NCT02390076|OG000|Outcome|Left Active LLLT|"Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy~Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer."
11228414|NCT02390076|OG001|Outcome|Right Active LLLT|"Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy~Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer."
11228415|NCT02390076|OG002|Outcome|Sham LLLT|"Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.~Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response."
11228416|NCT02390076|EG000|Reported Event|Left Active LLLT|"Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy~Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer."
11228417|NCT02390076|EG001|Reported Event|Right Active LLLT|"Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy~Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer."
11228418|NCT02390076|EG002|Reported Event|Sham LLLT|"Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy~Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.~Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response."
11228419|NCT02390167|BG000|Baseline|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11228420|NCT02390167|FG000|Participant Flow|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11228421|NCT02390167|OG000|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11164624|NCT01964950|BG000|Baseline|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164625|NCT01964950|BG001|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164626|NCT01964950|BG002|Baseline|Total|Total of all reporting groups
11164627|NCT01964950|FG000|Participant Flow|All Population (Alogliptin)|All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164628|NCT01964950|OG000|Outcome|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164629|NCT01964950|OG001|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164630|NCT01964950|OG000|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
11164631|NCT01964950|EG000|Reported Event|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164632|NCT01964950|EG001|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164633|NCT01964963|BG000|Baseline|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
11164634|NCT01964963|FG000|Participant Flow|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
11164635|NCT01964963|OG000|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
11164636|NCT01964963|EG000|Reported Event|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
11164637|NCT01964976|BG000|Baseline|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164638|NCT01964976|BG001|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164639|NCT01964976|BG002|Baseline|Total|Total of all reporting groups
11164640|NCT01964976|FG000|Participant Flow|All Population|All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164641|NCT01964976|OG000|Outcome|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164642|NCT01964976|OG001|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164643|NCT01964976|OG000|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
11164644|NCT01964976|EG000|Reported Event|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164645|NCT01964976|EG001|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
11164646|NCT01965002|BG000|Baseline|MRgHIFU|The InSightec ExAblate 2000 MRgHIFU system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue. The treatment process begins with the physician acquiring a set of MR images, identifying one or more target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment. The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated. Approximately 100 individual sonications can be delivered over a 3-hour period to complete a treatment.
11164647|NCT01965002|FG000|Participant Flow|MRgHIFU|The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue. The treatment process begins with the physician acquiring a set of MR images, identifying 1+ target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment. The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated. About 100 individual sonications can be delivered over a 3-hour period to complete a treatment.
11164648|NCT01965002|OG000|Outcome|MRgHIFU|The InSightec ExAblate 2000 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system being used for the ablation of tumor tissue
11164649|NCT01965002|OG000|Outcome|MRgHIFU|In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice. The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed. Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.
11164650|NCT01965002|OG000|Outcome|MRgHIFU|The InSightec ExAblate 2000 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system being used for the ablation of tumor tissue.
11164651|NCT01965002|EG000|Reported Event|MRgHIFU|The InSightec ExAblate 2000 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system being used for the ablation of tumor tissue
11164652|NCT01965067|BG000|Baseline|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
11164653|NCT01965067|BG001|Baseline|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
11164654|NCT01965067|BG002|Baseline|Total|Total of all reporting groups
11164655|NCT01965067|FG000|Participant Flow|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
11164656|NCT01965067|FG001|Participant Flow|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
11164657|NCT01965067|OG000|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
11164658|NCT01965067|OG001|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
11164659|NCT01965067|EG000|Reported Event|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
11164660|NCT01965067|EG001|Reported Event|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
11164661|NCT01965158|BG000|Baseline|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
11164662|NCT01965158|BG001|Baseline|Placebo|Participants received placebo orally once daily for 12 weeks.
11164663|NCT01965158|BG002|Baseline|Total|Total of all reporting groups
11164664|NCT01965158|FG000|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
11164665|NCT01965158|FG001|Participant Flow|Placebo|Participants received placebo orally once daily for 12 weeks.
11164666|NCT01965158|OG000|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
11164667|NCT01965158|OG001|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
11164668|NCT01965158|EG000|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
11164669|NCT01965158|EG001|Reported Event|Placebo|Participants received placebo orally once daily for 12 weeks.
11164670|NCT01965262|BG000|Baseline|Overall Baseline Characteristics|"Randomized to wear the Hema-copolymer lens pair or the etafilcon A lens pair for one week then cross over to the alternate pair~Hema-copolymer Lens: Hema-copolymer lens pair or the Etafilcon A lens pair~etafilcon A Lens: Hema-copolymer lens pair or the Etafilcon A lens pair"
11164671|NCT01965262|FG000|Participant Flow|Hema-copolymer Lens, Then Etafilcon A Lens|Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair.
11164672|NCT01965262|FG001|Participant Flow|Etafilcon A Lens, Then Hema-copoloymer Lens|Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair.
11164673|NCT01965262|OG000|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
11164674|NCT01965262|OG001|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
11164675|NCT01965262|EG000|Reported Event|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
11164676|NCT01965262|EG001|Reported Event|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
11164677|NCT01965288|BG000|Baseline|Comfilcon A Then Lotrafilcon B|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164678|NCT01965288|BG001|Baseline|Lotrafilcon B Then Comfilcon A|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164679|NCT01965288|BG002|Baseline|Total|Total of all reporting groups
11164680|NCT01965288|FG000|Participant Flow|Comfilcon A Then Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164681|NCT01965288|FG001|Participant Flow|Lotrafilcon B Then Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164682|NCT01965288|OG000|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
11164683|NCT01965288|OG000|Outcome|Overall Study Group|All 60 subjects after removal of habitual lens and prior to dispense of study lens.
11164684|NCT01965288|OG000|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164685|NCT01965288|OG001|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164686|NCT01965288|OG001|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
11164687|NCT01965288|OG000|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
11164688|NCT01965288|OG000|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
11164689|NCT01965288|OG000|Outcome|Comfilcon A|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
11164690|NCT01965288|OG001|Outcome|Lotrafilcon B|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
11164691|NCT01965288|OG000|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
11164692|NCT01965288|OG000|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164693|NCT01965288|OG001|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164694|NCT01965288|OG002|Outcome|Habitual|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164695|NCT01965288|OG002|Outcome|Neither|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164696|NCT01965288|EG000|Reported Event|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
11164697|NCT01965288|EG001|Reported Event|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
11164698|NCT01965327|BG000|Baseline|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
11164699|NCT01965327|FG000|Participant Flow|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
11164700|NCT01965327|OG000|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
11164701|NCT01965327|EG000|Reported Event|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
11164702|NCT01965366|BG000|Baseline|Dexamethasone + VRE|"0.5 mg DEX + virtual reality exposure therapy~Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.~0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions."
11164703|NCT01965366|BG001|Baseline|Placebo + VRE|"Placebo + virtual reality exposure therapy~Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently."
11164704|NCT01965366|BG002|Baseline|Total|Total of all reporting groups
11164705|NCT01965366|FG000|Participant Flow|Dexamethasone + VRE|"0.5 mg DEX + virtual reality exposure therapy~Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.~0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions."
11164706|NCT01965366|FG001|Participant Flow|Placebo + VRE|"Placebo + virtual reality exposure therapy~Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently."
11164707|NCT01965366|OG000|Outcome|Dexamethasone + VRE|"0.5 mg DEX + virtual reality exposure therapy~Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.~0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions."
11164708|NCT01965366|OG001|Outcome|Placebo + VRE|"Placebo + virtual reality exposure therapy~Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently."
11164709|NCT01965366|EG000|Reported Event|Dexamethasone + VRE|"0.5 mg DEX + virtual reality exposure therapy~Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.~0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions."
11164710|NCT01965366|EG001|Reported Event|Placebo + VRE|"Placebo + virtual reality exposure therapy~Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently."
11164711|NCT01965431|BG000|Baseline|Overall Study|This study is randomised, single-blind, 3-period crossover having 3 treatments, BI 207127 and Faldaprevir for 3 days (Days -2 to 1), placebo to BI 207127 plus placebo to Faldaprevir for 3 days (Days -2 to 1) and Moxifloxacin 400 mg as single dose (Day 1).
11164712|NCT01965431|FG000|Participant Flow|T/R1/R2|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) twice daily (bid) were administered on day -2 and day -1 and 600 mg once daily (qd) on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg once daily (qd) on day -1 and day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2) : Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
11164713|NCT01965431|FG001|Participant Flow|T/R2/R1|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
11164714|NCT01965431|FG002|Participant Flow|R1/T/R2|Patients were treated with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2):Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
11164715|NCT01965431|FG003|Participant Flow|R1/R2/T|Patients were treated in the morning with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
11164716|NCT01965431|FG004|Participant Flow|R2/T/R1|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered on as single dose on day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
11164717|NCT01965431|FG005|Participant Flow|R2/R1/T|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
11164718|NCT01965431|OG000|Outcome|BI 207127+ Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
11164719|NCT01965431|OG001|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
11164720|NCT01965431|OG000|Outcome|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day 1 with 240 mL of water.
11164721|NCT01965431|OG000|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
11228422|NCT02390167|OG000|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary palm blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11228423|NCT02390167|OG000|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11228424|NCT02390167|OG000|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
11228425|NCT02390167|OG000|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
11228426|NCT02390167|EG000|Reported Event|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11228427|NCT02390219|BG000|Baseline|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
11228428|NCT02390219|FG000|Participant Flow|LUM/IVA|Participants received lumacaftor (LUM) 400 milligram (mg) in combination with ivacaftor (IVA) 250 mg as fixed-dose combination (FDC) tablet orally every 12 hours (q12h) for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
11228429|NCT02390219|OG000|Outcome|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
11228430|NCT02390219|EG000|Reported Event|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
11228431|NCT02390557|BG000|Baseline|Control - Standard Practice|Standard measures of quality as scheduled through One Care demonstration
11228432|NCT02390557|BG001|Baseline|Survey Arm|Consumer surveyed with Persons with Disabilities Quality Survey (PDQ-S) Results given to provider along with standard quality metric data as scheduled through One Care
11228433|NCT02390557|BG002|Baseline|YES Health|"Initiative created by persons with disabilities for persons with disabilities to actively engage in collecting, analyzing and reporting on quality of care from the consumer perspective. The purpose is to engage eligible enrollees to answer brief surveys surrounding various themes about the care and experiences they receive through One Care. Subsequent brief, actionable reports are fed back to primary care provider practices randomized to this arm.~YES Health: Intervention Arm"
11228434|NCT02390557|BG003|Baseline|Total|Total of all reporting groups
11228435|NCT02390557|FG000|Participant Flow|Control - Standard Practice|Standard measures of quality as scheduled through One Care demonstration
11228436|NCT02390557|FG001|Participant Flow|Survey Arm|Consumer surveyed with Persons with Disabilities Quality Survey (PDQ-S) Results given to provider along with standard quality metric data as scheduled through One Care
11228437|NCT02390557|FG002|Participant Flow|YES Health|"Initiative created by persons with disabilities for persons with disabilities to actively engage in collecting, analyzing and reporting on quality of care from the consumer perspective. The purpose is to engage eligible enrollees to answer brief surveys surrounding various themes about the care and experiences they receive through One Care. Subsequent brief, actionable reports are fed back to primary care provider practices randomized to this arm.~YES Health: Intervention Arm"
11228438|NCT02390557|OG000|Outcome|Control - Standard Practice|Control group with no intervention
11228439|NCT02390557|OG001|Outcome|Survey Arm|Consumer surveyed with Persons with Disabilities Quality Survey (PDQ-S) Results given to provider along with standard quality metric data as scheduled through One Care
11228440|NCT02390557|OG002|Outcome|YES Health|"Initiative created by persons with disabilities for persons with disabilities to actively engage in collecting, analyzing and reporting on quality of care from the consumer perspective. The purpose is to engage eligible enrollees to answer brief surveys surrounding various themes about the care and experiences they receive through One Care. Subsequent brief, actionable reports are fed back to primary care provider practices randomized to this arm.~YES Health: Intervention Arm"
11228441|NCT02390557|EG000|Reported Event|Control - Standard Practice|Standard measures of quality as scheduled through One Care demonstration
11228442|NCT02390557|EG001|Reported Event|Survey Arm|Consumer surveyed with Persons with Disabilities Quality Survey (PDQ-S) Results given to provider along with standard quality metric data as scheduled through One Care
11228443|NCT02390557|EG002|Reported Event|YES Health|"Initiative created by persons with disabilities for persons with disabilities to actively engage in collecting, analyzing and reporting on quality of care from the consumer perspective. The purpose is to engage eligible enrollees to answer brief surveys surrounding various themes about the care and experiences they receive through One Care. Subsequent brief, actionable reports are fed back to primary care provider practices randomized to this arm.~YES Health: Intervention Arm"
11164722|NCT01965431|OG001|Outcome|Placebo to BI 207127) + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
11164723|NCT01965431|EG000|Reported Event|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
11164724|NCT01965431|EG001|Reported Event|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day1 with 240 mL of water.
11164725|NCT01965431|EG002|Reported Event|Placebo (BI 207127) + Placebo (Faldaprevir)|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
11164726|NCT01965535|BG000|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
11164727|NCT01965535|BG001|Baseline|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
11164728|NCT01965535|BG002|Baseline|Total|Total of all reporting groups
11164729|NCT01965535|FG000|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus placebo to match ribavirin (RBV) in a divided daily dose for 24 weeks
11164730|NCT01965535|FG001|Participant Flow|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
11164731|NCT01965535|OG000|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
11164732|NCT01965535|OG001|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
11164733|NCT01965535|EG000|Reported Event|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
11164734|NCT01965535|EG001|Reported Event|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
11164735|NCT01965561|BG000|Baseline|Junctional Tourniquet Use|"Junctional tourniquet use followed by rest, repeat~Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is an bladder within a belt. CRC is a vice."
11164736|NCT01965561|FG000|Participant Flow|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat. Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is a bladder within a belt. CRC is a vice.
11164737|NCT01965561|OG000|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
11164738|NCT01965561|OG001|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
11164739|NCT01965561|OG002|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
11164740|NCT01965561|OG003|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
11164741|NCT01965561|EG000|Reported Event|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat.
11164742|NCT01965600|BG000|Baseline|All Participants|Participants received PF-06282999 125 mg TID or 500 mg BID or matching placebo orally in tablet form from Days 1 to 3. On Day 3, participants received a dose of LPS as an IV bolus at a dose of 4 ng/kg over 45-60 secs 2 hours after the morning dose of PF-06282999 or matching placebo. A final dose of PF-06282999 or matching placebo was administered on the evening of Day 3. Period 2 started after a washout period of approximately 15 days with at least 21 days in between administration of LPS. Participants who took active treatment (PF-06282999) in Period 1 received placebo in Period 2 and vice versa.
11164743|NCT01965600|FG000|Participant Flow|PF-06282999 125 mg TID Followed by Placebo|Participants received PF-06282999 125 milligrams (mg) three times daily (TID) orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
11164744|NCT01965600|FG001|Participant Flow|Placebo Followed by PF-06282999 125 mg TID|Participants received placebo orally via tablets. Placebo matching PF-06282999 125 mg TID were administered on Days 1-3 at approximately 8am, 2pm, and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 125 mg TID in the same manner as placebo in the first period.
11164745|NCT01965600|FG002|Participant Flow|PF-06282999 500 mg BID Followed by Placebo|Participants received PF-06282999 500 milligrams (mg) twice daily (BID) orally in tablet form from Days 1 to 3 (8am and 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
11233899|NCT02431468|OG002|Outcome|Placebo|"Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution."
11164746|NCT01965600|FG003|Participant Flow|Placebo Followed by PF-06282999 500 mg BID|Participants received placebo orally via tablets. Placebo matching PF-06282999 500 mg BID were administered on Days 1-3 at 8am and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 500 mg BID in the same manner as placebo in the first period.
11164747|NCT01965600|OG000|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
11164748|NCT01965600|OG001|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
11164749|NCT01965600|OG002|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
11164750|NCT01965600|EG000|Reported Event|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
11164751|NCT01965600|EG001|Reported Event|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
11164752|NCT01965600|EG002|Reported Event|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
11164753|NCT01965652|BG000|Baseline|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
11164754|NCT01965652|BG001|Baseline|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
11164755|NCT01965652|BG002|Baseline|Total|Total of all reporting groups
11164756|NCT01965652|FG000|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
11164757|NCT01965652|FG001|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
11164758|NCT01965652|OG000|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
11164759|NCT01965652|OG001|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
11164760|NCT01965652|EG000|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
11164761|NCT01965652|EG001|Reported Event|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
11164762|NCT01965665|BG000|Baseline|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
11164763|NCT01965665|FG000|Participant Flow|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
11164764|NCT01965665|OG000|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
11164765|NCT01965665|EG000|Reported Event|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
11164766|NCT01965756|BG000|Baseline|Metformin, Then Placebo|Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.
11164767|NCT01965756|BG001|Baseline|Placebo, Then Metformin|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
11164768|NCT01965756|BG002|Baseline|Total|Total of all reporting groups
11164769|NCT01965756|FG000|Participant Flow|Metformin, Then Placebo (Treatment Sequence A, 0 to 16 Weeks)|Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.
11164770|NCT01965756|FG001|Participant Flow|Placebo, Then Metformin (Treatment Sequence B, 0 to 16 Weeks)|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
11164771|NCT01965756|OG000|Outcome|Metformin, Then Placebo|Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.
11164772|NCT01965756|OG001|Outcome|Placebo, Then Metformin|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
11164773|NCT01965756|OG000|Outcome|Metformin, Then Placebo|"Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.~Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached."
11164774|NCT01965756|OG000|Outcome|Metformin, Then Placebo|"Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.~Metformin~Placebos"
11164775|NCT01965756|OG001|Outcome|Placebo, Then Metformin|"Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.~Metformin~Placebos"
11164776|NCT01965756|OG001|Outcome|Placebo, Then Metformin|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
11164777|NCT01965756|EG000|Reported Event|Metformin|This group includes subjects treated with metformin for the first 8 weeks of the study, as well as subjects treated with metformin during the second 8 weeks of the study.
11164778|NCT01965756|EG001|Reported Event|Placebo|This group includes subjects treated with placebo for the first 8 weeks of the study, as well as subjects treated with placebo during the second 8 weeks of the study.
11164779|NCT01965834|BG000|Baseline|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
11164780|NCT01965834|FG000|Participant Flow|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
11164781|NCT01965834|OG000|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
11164782|NCT01965834|EG000|Reported Event|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
11164783|NCT01965860|BG000|Baseline|PROSPECT|"the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator.~additional curriculum"
11164784|NCT01965860|BG001|Baseline|E-LEARNING|the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises.
11164785|NCT01965860|BG002|Baseline|CONTROL|The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
11164786|NCT01965860|BG003|Baseline|Total|Total of all reporting groups
11164787|NCT01965860|FG000|Participant Flow|PROSPECT|"the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator.~additional curriculum"
11164788|NCT01965860|FG001|Participant Flow|E-LEARNING|the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises.
11164789|NCT01965860|FG002|Participant Flow|CONTROL|The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
11164790|NCT01965860|OG000|Outcome|PROSPECT|"the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator.~additional curriculum"
11164791|NCT01965860|OG001|Outcome|E-LEARNING|the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises.
11164792|NCT01965860|OG002|Outcome|CONTROL|The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
11164793|NCT01965860|EG000|Reported Event|PROSPECT|"the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator.~additional curriculum"
11164794|NCT01965860|EG001|Reported Event|E-LEARNING|the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises.
11164795|NCT01965860|EG002|Reported Event|CONTROL|The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
11164796|NCT01965899|BG000|Baseline|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
11164797|NCT01965899|FG000|Participant Flow|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
11164798|NCT01965899|OG000|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
11164799|NCT01965899|OG000|Outcome|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from the automatically detected arrhythmias. Documentation of episode occurrence will be retained.
11164800|NCT01965899|EG000|Reported Event|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
11164801|NCT01965938|BG000|Baseline|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
11164802|NCT01965938|BG001|Baseline|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
11164803|NCT01965938|BG002|Baseline|Total|Total of all reporting groups
11164804|NCT01965938|FG000|Participant Flow|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
11164805|NCT01965938|FG001|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
11164806|NCT01965938|OG000|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
11164807|NCT01965938|OG001|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
11164808|NCT01965938|OG000|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
11164809|NCT01965938|OG001|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
11164810|NCT01965938|EG000|Reported Event|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
11164811|NCT01965938|EG001|Reported Event|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
11164812|NCT01966003|BG000|Baseline|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
11164813|NCT01966003|BG001|Baseline|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
11164814|NCT01966003|BG002|Baseline|Total|Total of all reporting groups
11164815|NCT01966003|FG000|Participant Flow|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
11164816|NCT01966003|FG001|Participant Flow|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
11164817|NCT01966003|OG000|Outcome|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
11164818|NCT01966003|OG001|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
11164819|NCT01966003|EG000|Reported Event|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
11164820|NCT01966003|EG001|Reported Event|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
11164821|NCT01966042|BG000|Baseline|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
11164822|NCT01966042|FG000|Participant Flow|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and autologous bone marrow mononuclear cells infusion.~Local sedation: All subjects enrolled underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled underwent bone marrow aspiration after anesthesia from the posterior iliac crest. The sample was aspirated into sterile syringes and brought to the cell processing laboratory. The processing was in accordance to the Standard Operating Procedure developed observing Good Practice Guidelines.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened, the surgeon drew up the cells into syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
11164823|NCT01966042|OG000|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
11164824|NCT01966042|EG000|Reported Event|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
11164825|NCT01966068|BG000|Baseline|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
11164826|NCT01966068|BG001|Baseline|MyAsthma Web Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once
11164827|NCT01966068|BG002|Baseline|Total|Total of all reporting groups
11164828|NCT01966068|FG000|Participant Flow|MyAsthma Web Portal|The portal, MyAsthma, provided asthma education, collected patient-reported outcomes, evaluated medication use and side effects, and tracked parents' concerns and goals. Parents logged into the web portal each month, and the information entered by parents was shared through the electronic health record with the child's primary care provider.
11164829|NCT01966068|OG000|Outcome|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
11164830|NCT01966068|OG001|Outcome|MyAsthma Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once.
11164831|NCT01966068|EG000|Reported Event|MyAsthma Web Portal|"The portal, MyAsthma, will provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' concerns and goals. Parents will log into the web portal each month, and the information entered by parents will be shared through the electronic health record with the child's primary care provider.~MyAsthma Web Portal"
11164832|NCT01966107|BG000|Baseline|Aclidinium Bromide|Randomized subjects were administered Aclidinium bromide 400 μg BID, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose dry powder inhalation device (DPI). Subjects on a LAMA (long-acting muscarinic antagonist i.e., inhaled anticholinergics) had to washout 2 weeks prior to randomization.
11164833|NCT01966107|BG001|Baseline|Placebo|Randomized subjects were administered placebo, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose DPI. Subjects on a LAMA (ie, inhaled anticholinergics) had to washout 2 weeks prior to randomization.
11164834|NCT01966107|BG002|Baseline|Total|Total of all reporting groups
11164835|NCT01966107|FG000|Participant Flow|Aclidinium Bromide|Randomized subjects were administered Aclidinium bromide 400 μg BID, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose dry powder inhalation device (DPI). Subjects on a LAMA (long-acting muscarinic antagonist i.e., inhaled anticholinergics) had to washout 2 weeks prior to randomization.
11164836|NCT01966107|FG001|Participant Flow|Placebo|Randomized subjects were administered placebo, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose DPI. Subjects on a LAMA (ie, inhaled anticholinergics) had to washout 2 weeks prior to randomization.
11164837|NCT01966107|OG000|Outcome|Aclidinium Bromide|Randomized subjects were administered Aclidinium bromide 400 μg BID, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose dry powder inhalation device (DPI). Subjects on a LAMA (long-acting muscarinic antagonist i.e., inhaled anticholinergics) had to washout 2 weeks prior to randomization.
11164838|NCT01966107|OG001|Outcome|Placebo|Randomized subjects were administered placebo, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose DPI. Subjects on a LAMA (ie, inhaled anticholinergics) had to washout 2 weeks prior to randomization.
11164839|NCT01966107|EG000|Reported Event|Aclidinium Bromide|Randomized subjects were administered Aclidinium bromide 400 μg BID, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose dry powder inhalation device (DPI). Subjects on a LAMA (long-acting muscarinic antagonist i.e., inhaled anticholinergics) had to washout 2 weeks prior to randomization.
11164840|NCT01966107|EG001|Reported Event|Placebo|Randomized subjects were administered placebo, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose DPI. Subjects on a LAMA (ie, inhaled anticholinergics) had to washout 2 weeks prior to randomization.
11164841|NCT01966120|BG000|Baseline|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
11164842|NCT01966120|BG001|Baseline|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
11164843|NCT01966120|BG002|Baseline|Total|Total of all reporting groups
11164844|NCT01966120|FG000|Participant Flow|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the investigational medicinal product (IMP) was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
11164845|NCT01966120|FG001|Participant Flow|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
11164846|NCT01966120|OG000|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
11164847|NCT01966120|OG001|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
11164848|NCT01966120|EG000|Reported Event|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
11164849|NCT01966120|EG001|Reported Event|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
11164850|NCT01966159|BG000|Baseline|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
11164851|NCT01966159|BG001|Baseline|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
11164852|NCT01966159|BG002|Baseline|Total|Total of all reporting groups
11164853|NCT01966159|FG000|Participant Flow|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
11164854|NCT01966159|FG001|Participant Flow|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
11164855|NCT01966159|OG000|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
11164856|NCT01966159|OG001|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
11164857|NCT01966159|EG000|Reported Event|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
11164858|NCT01966159|EG001|Reported Event|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
11164859|NCT01966354|BG000|Baseline|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164860|NCT01966354|BG001|Baseline|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11228444|NCT02390791|BG000|Baseline|Enhanced myADHDportal.Com|"Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child~enhanced myADHDportal.com: Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child"
11349190|NCT04113785|FG000|Participant Flow|Klassic TKA|"Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.~Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee"
11349191|NCT04113785|OG000|Outcome|Klassic TKA|"Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.~Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee"
11349192|NCT04113785|EG000|Reported Event|Klassic TKA|"Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.~Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee"
11349193|NCT04113694|BG000|Baseline|Humalog Subjects Extended Wear Infusion Set|"Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.~Extended Infusion Set: Humalog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours."
11349194|NCT04113694|BG001|Baseline|Novolog Subjects Extended Wear Infusion Set|"Each Novolog subject was given 12 Extended Wear Infusion Sets to wear.~Extended Infusion Set: Novolog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours."
11349195|NCT04113694|BG002|Baseline|Total|Total of all reporting groups
11349196|NCT04113694|FG000|Participant Flow|Extended Wear Infusion Set|"Each subject was given 12 Extended Wear Infusion Sets to wear.~Extended Infusion Set: each subject was asked to wear each Extended Wear Infusion Set for at least 174 hours."
11349197|NCT04113694|OG000|Outcome|Extended Wear Infusion Set|"Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.~Extended Infusion Set: Humalog subjects were asked to wear Extended Wear Infusion Set for at least 174 hours."
11349198|NCT04113694|OG000|Outcome|Extended Wear Infusion Set|"Each Novolog subject was given 12 Extended Wear Infusion Sets to wear.~Extended Infusion Set: Novolog Subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours."
11349199|NCT04113694|OG000|Outcome|Extended Wear Infusion Set|"Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.~Extended Infusion Set: Humalog Subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours."
11164861|NCT01966354|BG002|Baseline|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164862|NCT01966354|BG003|Baseline|Total|Total of all reporting groups
11349200|NCT04113694|EG000|Reported Event|Humalog Subjects Extended Wear Infusion Set|"Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.~Extended Infusion Set: Humalog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours."
11349201|NCT04113694|EG001|Reported Event|Novolog Subjects Extended Wear Infusion Set|"Each Novolog subject was given 12 Extended Wear Infusion Sets to wear.~Extended Infusion Set: Novolog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours."
11357182|NCT03763175|FG002|Participant Flow|Placebo|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of placebo. Study activities will be the same across all three arms.~Placebo: A placebo will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11357183|NCT03763175|OG000|Outcome|SYN-010 21 mg|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (21 mg PO QD). Study activities will be the same across all three arms.~SYN-010 21 mg: 21 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11164863|NCT01966354|FG000|Participant Flow|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164864|NCT01966354|FG001|Participant Flow|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164865|NCT01966354|FG002|Participant Flow|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164866|NCT01966354|OG000|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164867|NCT01966354|OG001|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164868|NCT01966354|OG002|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164869|NCT01966354|EG000|Reported Event|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164870|NCT01966354|EG001|Reported Event|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11228445|NCT02390791|BG001|Baseline|Treatment as Usual Standard Portal|"Standard version of myADHDportal.com web software~treatment as usual standard portal: Standard version of myADHDportal.com web software"
11228446|NCT02390791|BG002|Baseline|Total|Total of all reporting groups
11349202|NCT04112160|BG000|Baseline|Control|normal saline 0.9%
11164871|NCT01966354|EG002|Reported Event|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
11164872|NCT01966380|BG000|Baseline|Leia and Hydroactive Surgical Dressing|In the case of this study, participants served as their own control.
11164873|NCT01966380|FG000|Participant Flow|Cross-over Assignment Leia|First intervention Leia, 5 Days, then second intervention Hydroactive surgical dressing 5 Days.
11164874|NCT01966380|FG001|Participant Flow|Cross-over Assignment Hydroactive Surgical Dressing|First intervention Hydroactive surgical dressing 5 Days, then second intervention Leia, 5 Days..
11164875|NCT01966380|OG000|Outcome|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
11164876|NCT01966380|OG001|Outcome|Hydroactivate Surgical Dressing|Intervention: Device, Hydroactivate surgical dressing. Cross-over design, the patient was his own controll. 6 patients were treated in total.
11164877|NCT01966380|EG000|Reported Event|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
11164878|NCT01966380|EG001|Reported Event|Hydroactive Surgical Dressing|"Intervention: Device: Hydroactive surgical dressing~Cross-over design, the patient was his own controll. 6 patients were treated in total."
11164879|NCT01966419|BG000|Baseline|Placebo|Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
11164880|NCT01966419|BG001|Baseline|Ornithine Phenylacetate|Participants receive ornithine phenylacetate up to 5 days via continuous IV infusion in addition to SOC
11164881|NCT01966419|BG002|Baseline|Total|Total of all reporting groups
11164882|NCT01966419|FG000|Participant Flow|Placebo|Participants receive matching placebo up to 5 days via continuous IV infusion in addition to standard of care (SOC)
11164883|NCT01966419|FG001|Participant Flow|Ornithine Phenylacetate|Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to SOC
11164884|NCT01966419|OG000|Outcome|Placebo|Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
11164885|NCT01966419|OG001|Outcome|Ornithine Phenylacetate|Participants receive ornithine phenylacetate up to 5 days via continuous IV infusion in addition to SOC
11164886|NCT01966419|EG000|Reported Event|Placebo|Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
11164887|NCT01966419|EG001|Reported Event|Ornithine Phenylacetate|Participants receive ornithine phenylacetate up to 5 days via continuous IV infusion in addition to SOC
11164888|NCT01966432|BG000|Baseline|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11164889|NCT01966432|BG001|Baseline|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11164890|NCT01966432|BG002|Baseline|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
11164891|NCT01966432|BG003|Baseline|Total|Total of all reporting groups
11164892|NCT01966432|FG000|Participant Flow|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11164893|NCT01966432|FG001|Participant Flow|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11349203|NCT04112160|BG001|Baseline|Ketorolac|30 mg of Ketorolac
11349204|NCT04112160|BG002|Baseline|Total|Total of all reporting groups
11164894|NCT01966432|FG002|Participant Flow|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
11164895|NCT01966432|OG000|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11164896|NCT01966432|OG001|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11164897|NCT01966432|OG002|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
11164898|NCT01966432|OG001|Outcome|SBI Group|"Screening, Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11164899|NCT01966432|OG002|Outcome|S Group|Screening group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
11164900|NCT01966432|EG000|Reported Event|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11164901|NCT01966432|EG001|Reported Event|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
11164902|NCT01966432|EG002|Reported Event|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
11164903|NCT01966445|BG000|Baseline|GSK2849330 1.4 mg/kg Weekly|Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
11164904|NCT01966445|BG001|Baseline|GSK2849330 3 mg/kg Every 2 Weeks|Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
11164905|NCT01966445|BG002|Baseline|GSK2849330 3 mg/kg Weekly|Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
11164906|NCT01966445|BG003|Baseline|GSK2849330 10 mg/kg Every 2 Weeks|Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
11164907|NCT01966445|BG004|Baseline|GSK2849330 30 mg/kg Every 2 Weeks|Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
11164908|NCT01966445|BG005|Baseline|GSK2849330 30 mg/kg Weekly|Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
11164909|NCT01966445|BG006|Baseline|Total|Total of all reporting groups
11164910|NCT01966445|FG000|Participant Flow|Part1: GSK2849330 1.4 mg/kg Weekly|Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
11164911|NCT01966445|FG001|Participant Flow|Part1: GSK2849330 3 mg/kg Every 2 Weeks|Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
11164912|NCT01966445|FG002|Participant Flow|Part1: GSK2849330 3 mg/kg Weekly|Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
11164913|NCT01966445|FG003|Participant Flow|Part1: GSK2849330 10 mg/kg Every 2 Weeks|Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
11164914|NCT01966445|FG004|Participant Flow|Part1: GSK2849330 30 mg/kg Every 2 Weeks|Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
11164915|NCT01966445|FG005|Participant Flow|Part1: GSK2849330 30 mg/kg Weekly|Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days.
11164916|NCT01966445|FG006|Participant Flow|Part2: GSK2849330 30 mg/kg Weekly|Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days.
11164917|NCT01966445|OG000|Outcome|GSK2849330 1.4 mg/kg Weekly|Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
11164918|NCT01966445|OG001|Outcome|GSK2849330 3 mg/kg Every 2 Weeks|Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
11164919|NCT01966445|OG002|Outcome|GSK2849330 3 mg/kg Weekly|Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
11164920|NCT01966445|OG003|Outcome|GSK2849330 10 mg/kg Every 2 Weeks|Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
11164921|NCT01966445|OG004|Outcome|GSK2849330 30 mg/kg Every 2 Weeks|Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
11164922|NCT01966445|OG005|Outcome|GSK2849330 30 mg/kg Weekly|Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
11164923|NCT01966445|OG005|Outcome|GSK2849330 30 mg/kg Weekly|Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from Part 1 (dose-escalation cohort).
11164924|NCT01966445|OG000|Outcome|GSK2849330 30 mg/kg Weekly|Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly in Part 2 (dose expansion cohort).
11164925|NCT01966445|EG000|Reported Event|GSK2849330 1.4 mg/kg Weekly|Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
11164926|NCT01966445|EG001|Reported Event|GSK2849330 3 mg/kg Every 2 Weeks|Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
11164927|NCT01966445|EG002|Reported Event|GSK2849330 3 mg/kg Weekly|Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
11164928|NCT01966445|EG003|Reported Event|GSK2849330 10 mg/kg Every 2 Weeks|Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
11164929|NCT01966445|EG004|Reported Event|GSK2849330 30 mg/kg Every 2 Weeks|Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
11164930|NCT01966445|EG005|Reported Event|GSK2849330 30 mg/kg Weekly|Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
11164931|NCT01966458|BG000|Baseline|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
11164932|NCT01966458|BG001|Baseline|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
11164933|NCT01966458|BG002|Baseline|Total|Total of all reporting groups
11164934|NCT01966458|FG000|Participant Flow|HeartWare® Ventricular Assist System (VAS)|HeartWare® Ventricular Assist System (VAS): The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
11164935|NCT01966458|FG001|Participant Flow|Control Left Ventricular Assist Device (LVAD)|Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.
11164936|NCT01966458|OG000|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
11164937|NCT01966458|OG001|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
11164938|NCT01966458|EG000|Reported Event|HeartWare® VAS|"Implant of HeartWare® Ventricular Assist System~HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use."
11164939|NCT01966458|EG001|Reported Event|Control LVAD|"Implant of FDA-approved LVAD approved for destination therapy~Control LVAD: Any FDA-approved LVAD for destination therapy."
11164940|NCT01966718|BG000|Baseline|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
11164941|NCT01966718|FG000|Participant Flow|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
11164942|NCT01966718|OG000|Outcome|Swollen Joints|Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).
11164943|NCT01966718|OG001|Outcome|Tender Joints|Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
11164944|NCT01966718|OG000|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
11164945|NCT01966718|EG000|Reported Event|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
11164946|NCT01966770|BG000|Baseline|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
11164947|NCT01966770|FG000|Participant Flow|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
11164948|NCT01966770|OG000|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
11164949|NCT01966770|OG000|Outcome|B55 PREMIER ASPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
11164950|NCT01966770|OG001|Outcome|B55 SPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
11164951|NCT01966770|OG002|Outcome|BF SPHERE LENS|Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
11164952|NCT01966770|OG003|Outcome|AV SPHERE LENS|Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
11164953|NCT01966770|OG004|Outcome|PCM SPHERE LENS|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
11164954|NCT01966770|OG005|Outcome|F55 SPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
11164955|NCT01966770|OG006|Outcome|F55 ASPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
11164956|NCT01966770|OG000|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
11164957|NCT01966770|OG001|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
11164958|NCT01966770|OG002|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
11164959|NCT01966770|OG003|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
11164960|NCT01966770|OG004|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
11164961|NCT01966770|OG005|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
11164962|NCT01966770|OG000|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
11164963|NCT01966770|OG001|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
11349205|NCT04112160|FG000|Participant Flow|Control|"normal saline 0.9%~normal saline: normal saline"
11164964|NCT01966770|OG002|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
11164965|NCT01966770|OG003|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
11164966|NCT01966770|OG004|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
11164967|NCT01966770|OG005|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
11164968|NCT01966770|OG000|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
11164969|NCT01966770|OG000|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
11164970|NCT01966770|OG000|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
11164971|NCT01966770|OG000|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
11164972|NCT01966770|OG000|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
11164973|NCT01966770|OG000|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
11164974|NCT01966770|EG000|Reported Event|Pair 1 (Ocufilcon D / Ocufilcon D)|Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
11164975|NCT01966770|EG001|Reported Event|Pair 2 (Ocufilcon D / Enfilcon A)|Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
11164976|NCT01966770|EG002|Reported Event|Pair 3 (Ocufilcon D / Comfilcon A)|Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
11164977|NCT01966770|EG003|Reported Event|Pair 4 (Methafilcon A / Methafilcon A)|Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
11164978|NCT01966770|EG004|Reported Event|Pair 5 (Methafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
11164979|NCT01966770|EG005|Reported Event|Pair 6 (Omafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
11164980|NCT01966796|BG000|Baseline|PSI II|PSI less than 70 or equal to 70
11164981|NCT01966796|BG001|Baseline|PSI III|PSI 70-90
11164982|NCT01966796|BG002|Baseline|PSI IV|PSI 90-130
11164983|NCT01966796|BG003|Baseline|PSI V|PSI more than 130
11164984|NCT01966796|BG004|Baseline|Total|Total of all reporting groups
11164985|NCT01966796|FG000|Participant Flow|PSI II|Pneumonia severity index less than 70 or equal to 70, (Pneumonia is more severe if the index is higher)
11164986|NCT01966796|FG001|Participant Flow|PSI III|Pneumonia severity index 70-90
11164987|NCT01966796|FG002|Participant Flow|PSI IV|Pneumonia severity index 91-130
11164988|NCT01966796|FG003|Participant Flow|PSI V|Pneumonia severity index more than 130
11164989|NCT01966796|OG000|Outcome|PSI II|Pneumonia severity index less than 70 or equal to 70, (Pneumonia is more severe if the index is higher)
11164990|NCT01966796|OG001|Outcome|PSI III|Pneumonia severity index 70-90
11164991|NCT01966796|OG002|Outcome|PSI IV|Pneumonia severity index 91-130
11164992|NCT01966796|OG003|Outcome|PSI V|Pneumonia severity index more than 130
11164993|NCT01966796|OG000|Outcome|PSI II|PSI less than 70 or equal to 70
11164994|NCT01966796|OG001|Outcome|PSI III|PSI 70-90
11164995|NCT01966796|OG002|Outcome|PSI IV|PSI 90-130
11164996|NCT01966796|OG003|Outcome|PSI V|PSI more than 130
11164997|NCT01966796|EG000|Reported Event|PSI II|PSI less than 70 or equal to 70
11164998|NCT01966796|EG001|Reported Event|PSI III|PSI 70-90
11164999|NCT01966796|EG002|Reported Event|PSI IV|PSI 90-130
11165000|NCT01966796|EG003|Reported Event|PSI V|PSI more than 130
11165001|NCT01966809|BG000|Baseline|Photofrin Photodynamic Therapy.|"Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2.~Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula:~Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence."
11165002|NCT01966809|FG000|Participant Flow|Photofrin Photodynamic Therapy.|"Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2.~Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula:~Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence."
11349206|NCT04112160|FG001|Participant Flow|Ketorolac|"30 mg of Ketorolac~Ketorolac: IM injection of either normal saline or Ketorolac"
11349207|NCT04112160|OG000|Outcome|Control|normal saline 0.9%
11349208|NCT04112160|OG001|Outcome|Ketorolac|30 mg of Ketorolac
11349209|NCT04112160|EG000|Reported Event|Control|normal saline 0.9%
11349210|NCT04112160|EG001|Reported Event|Ketorolac|30 mg of Ketorolac
11349211|NCT04112069|BG000|Baseline|All Study Participants|A two-period, random-order, cross-over design in 20 pediatric participants 7-17 years old with T1D
11349212|NCT04112069|FG000|Participant Flow|Usual Care, Then iLet Bionic Pancreas With Humalog or Novolog|"Usual Care first, then iLet Bionic Pancreas~Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. If randomized to the usual care arm first, subjects switched to the bionic pancreas arm following a 2-day washout period."
11349213|NCT04112069|FG001|Participant Flow|iLet Bionic Pancreas With Humalog or Novolog, Then Usual Care|"iLet Bionic Pancreas first, then Usual Care~Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. If randomized to the bionic pancreas arm first, subjects switched to the usual care arm following a 2-day washout period.~iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog"
11349214|NCT04112069|OG000|Outcome|Usual Care|"Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.~Usual Care: Usual care"
11349215|NCT04112069|OG001|Outcome|iLet Bionic Pancreas With Humalog or Novolog|"Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.~iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog"
11165003|NCT01966809|OG000|Outcome|Photofrin Photodynamic Therapy.|"Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2.~Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula:~Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence."
11165004|NCT01966809|EG000|Reported Event|Photofrin Photodynamic Therapy.|"Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2.~Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula:~Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence."
11165005|NCT01966900|BG000|Baseline|Group A|"Biological/Vaccine: CN54gp140 mixed with GLA-AF~Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF~CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF"
11349216|NCT04112069|EG000|Reported Event|Usual Care|"Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.~Usual Care: Usual care"
11349217|NCT04112069|EG001|Reported Event|iLet Bionic Pancreas With Humalog or Novolog|"Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.~iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog"
11349218|NCT04109703|BG000|Baseline|High Level Pulsed Heat|"Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.~Generation 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection."
11349219|NCT04109703|BG001|Baseline|Low Level Steady Heat|"Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.~Generation 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection."
11349220|NCT04109703|BG002|Baseline|Total|Total of all reporting groups
11165006|NCT01966900|BG001|Baseline|Group B|"Biological/Vaccine: CN54gp140 mixed with GLA-AF~Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF~CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF"
11165007|NCT01966900|BG002|Baseline|Total|Total of all reporting groups
11165008|NCT01966900|FG000|Participant Flow|Group A|"Biological/Vaccine: CN54gp140 mixed with GLA-AF~Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF~CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF"
11165009|NCT01966900|FG001|Participant Flow|Group B|"Biological/Vaccine: CN54gp140 mixed with GLA-AF~Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF~CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF"
11165010|NCT01966900|OG000|Outcome|Group A|"Biological/Vaccine: CN54gp140 mixed with GLA-AF~Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF~CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF"
11165011|NCT01966900|OG001|Outcome|Group B|"Biological/Vaccine: CN54gp140 mixed with GLA-AF~Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF~CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF"
11165012|NCT01966900|EG000|Reported Event|Group A|"Biological/Vaccine: CN54gp140 mixed with GLA-AF~Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF~CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF"
11165013|NCT01966900|EG001|Reported Event|Group B|"Biological/Vaccine: CN54gp140 mixed with GLA-AF~Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF~CN54gp140 mixed with GLA-AF: Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF"
11165014|NCT01966926|BG000|Baseline|Daily Weight Tracking|daily weighing frequency instructions and tips
11165015|NCT01966926|BG001|Baseline|Weekly Weight Tracking|weekly weighing frequency instructions and tips
11165016|NCT01966926|BG002|Baseline|Total|Total of all reporting groups
11165017|NCT01966926|FG000|Participant Flow|Daily Weight Tracking|daily weighing frequency instructions and tips
11165018|NCT01966926|FG001|Participant Flow|Weekly Weight Tracking|weekly weighing frequency instructions and tips
11165019|NCT01966926|OG000|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
11165020|NCT01966926|OG001|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
11165021|NCT01966926|EG000|Reported Event|Daily Weight Tracking|daily weighing frequency instructions and tips
11165022|NCT01966926|EG001|Reported Event|Weekly Weight Tracking|weekly weighing frequency instructions and tips
11165023|NCT01966978|BG000|Baseline|Control: Metformin, Insulin Detemir, Insulin Aspart|"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician~Metformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)~Detemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.~Insulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG <180"
11165024|NCT01966978|BG001|Baseline|Metformin, Insulin Determir, Liraglutide|"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)~Metformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)~Detemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.~Liraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"
11165025|NCT01966978|BG002|Baseline|Total|Total of all reporting groups
11165026|NCT01966978|FG000|Participant Flow|Control: Metformin, Insulin Detemir, Insulin Aspart|"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician~Metformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)~Detemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.~Insulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG <180"
11228447|NCT02390791|FG000|Participant Flow|Enhanced myADHDportal.Com|"Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child~enhanced myADHDportal.com: Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child"
11228448|NCT02390791|FG001|Participant Flow|Treatment as Usual Standard Portal|"Standard version of myADHDportal.com web software~treatment as usual standard portal: Standard version of myADHDportal.com web software"
11349221|NCT04109703|FG000|Participant Flow|High Level Pulsed Heat|"Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.~Generation 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection. The treatment algorithm used for all subjects in this arm pulsed heat to a temperature of 45 degrees C."
11349222|NCT04109703|FG001|Participant Flow|Low Level Steady Heat|"Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.~Generation 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection. The treatment algorithm used for all subjects in this arm maintained a steady temperature of 37 degrees C."
11165027|NCT01966978|FG001|Participant Flow|Metformin, Insulin Determir, Liraglutide|"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)~Metformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)~Detemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.~Liraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"
11165028|NCT01966978|OG000|Outcome|Control: Metformin, Insulin Detemir, Insulin Aspart|"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician~Metformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)~Detemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.~Insulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG <180"
11165029|NCT01966978|OG001|Outcome|Metformin, Insulin Determir, Liraglutide|"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)~Metformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)~Detemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.~Liraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"
11165030|NCT01966978|EG000|Reported Event|Control: Metformin, Insulin Detemir, Insulin Aspart|"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician~Metformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)~Detemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.~Insulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG <180"
11165031|NCT01966978|EG001|Reported Event|Metformin, Insulin Determir, Liraglutide|"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)~Metformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)~Detemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.~Liraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"
11165032|NCT01967069|BG000|Baseline|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
11165033|NCT01967069|BG001|Baseline|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
11165034|NCT01967069|BG002|Baseline|Total|Total of all reporting groups
11165035|NCT01967069|FG000|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
11165036|NCT01967069|FG001|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
11165037|NCT01967069|OG000|Outcome|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
11165038|NCT01967069|OG001|Outcome|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
11165039|NCT01967069|EG000|Reported Event|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
11165040|NCT01967069|EG001|Reported Event|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
11165041|NCT01967121|BG000|Baseline|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
11165042|NCT01967121|BG001|Baseline|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
11165043|NCT01967121|BG002|Baseline|Control|This is a control group where subjects will not perform an intervention.
11165044|NCT01967121|BG003|Baseline|Total|Total of all reporting groups
11165045|NCT01967121|FG000|Participant Flow|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
11165046|NCT01967121|FG001|Participant Flow|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
11165047|NCT01967121|FG002|Participant Flow|Control|This is a control group where subjects will not perform an intervention.
11165048|NCT01967121|OG000|Outcome|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
11165049|NCT01967121|OG001|Outcome|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
11165050|NCT01967121|OG002|Outcome|Control|This is a control group where subjects will not perform an intervention.
11165051|NCT01967121|EG000|Reported Event|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
11165052|NCT01967121|EG001|Reported Event|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
11165053|NCT01967121|EG002|Reported Event|Control|This is a control group where subjects will not perform an intervention.
11165054|NCT01967134|BG000|Baseline|H56:IC31 (50 ug H56) LTBI Neg|"LTBI Negative 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165055|NCT01967134|BG001|Baseline|H56:IC31 (15 ug H56) LTBI Pos|"LTBI Positive 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165056|NCT01967134|BG002|Baseline|H56:IC31 (50 ug H56) LTBI Pos|"LTBI Positive 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165057|NCT01967134|BG003|Baseline|Total|Total of all reporting groups
11165058|NCT01967134|FG000|Participant Flow|H56:IC31 (50 ug H56) LTBI Neg|"LTBI Negative 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165059|NCT01967134|FG001|Participant Flow|H56:IC31 (15 ug H56) LTBI Pos|"LTBI Positive 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165060|NCT01967134|FG002|Participant Flow|H56:IC31 (50 ug H56) LTBI Pos|"LTBI Positive 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165061|NCT01967134|OG000|Outcome|H56:IC31 (50 ug H56) LTBI Neg|"LTBI Negative 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165062|NCT01967134|OG001|Outcome|H56:IC31 (15 ug H56) LTBI Pos|"LTBI Positive 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165063|NCT01967134|OG002|Outcome|H56:IC31 (50 ug H56) LTBI Pos|"LTBI Positive 3 Doses~H56:IC31: H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165064|NCT01967134|EG000|Reported Event|Aeras-456 (50 ug H56/500 Nmol IC31) LTBI Negative|"LTBI Negative 3 Doses~Aeras-456: H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11228449|NCT02390791|OG000|Outcome|Enhanced myADHDportal.Com|"Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child~enhanced myADHDportal.com: Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child"
11228450|NCT02390791|OG001|Outcome|Treatment as Usual Standard Portal|"Standard version of myADHDportal.com web software~treatment as usual standard portal: Standard version of myADHDportal.com web software"
11228451|NCT02390791|EG000|Reported Event|Enhanced myADHDportal.Com|"Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child~enhanced myADHDportal.com: Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child"
11228452|NCT02390791|EG001|Reported Event|Treatment as Usual Standard Portal|"Standard version of myADHDportal.com web software~treatment as usual standard portal: Standard version of myADHDportal.com web software"
11228453|NCT02390908|BG000|Baseline|Site 1 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228454|NCT02390908|BG001|Baseline|Site 2 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228455|NCT02390908|BG002|Baseline|Site 3 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228456|NCT02390908|BG003|Baseline|Wait-list PLUS Condition|"Received the PLUS intervention at 12 months post baseline~PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.~Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention."
11228457|NCT02390908|BG004|Baseline|No-Treatment EMR Control Group|Patients whose electronic medical records (EMRs) were extracted for viral load and CD4 outcomes over the study period, but who were not enrolled in PLUS and did not receive the intervention.
11228458|NCT02390908|BG005|Baseline|Total|Total of all reporting groups
11228459|NCT02390908|FG000|Participant Flow|Site 1 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228460|NCT02390908|FG001|Participant Flow|Site 2 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228461|NCT02390908|FG002|Participant Flow|Site 3 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228462|NCT02390908|FG003|Participant Flow|Wait-list PLUS Condition|"Received the PLUS intervention at 12 months post-baseline~PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.~Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention."
11228463|NCT02390908|FG004|Participant Flow|No-Treatment EMR Control Group|"The EMRs of randomly selected patients who belonged to the TAU site and were not enrolled in the PLUS trial were matched on key patient characteristics for comparisons with EMRs of patients in the PLUS intervention and Waitlist control conditions. This matched cohort of patients received care at a fourth clinic that did not receive any intervention (i.e., PLUS or eTAU) and was considered as a natural history comparison group.~This group were only included in analyses comparing VL and CD4."
11228464|NCT02390908|OG000|Outcome|Site 1 Immediate PLUS Intervention|"Site 1 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228465|NCT02390908|OG001|Outcome|Site 2 Immediate PLUS Intervention|"Site 2 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11165065|NCT01967134|EG001|Reported Event|Aeras-456 (15 ug H56/500 Nmol IC31) LTBI Positive|"LTBI Positive 3 Doses~Aeras-456: H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165066|NCT01967134|EG002|Reported Event|Aeras-456 (50 ug H56 / 500 Nmol IC31) LTBI Positive|"LTBI Positive 3 Doses~Aeras-456: H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant."
11165067|NCT01967147|BG000|Baseline|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
11165068|NCT01967147|BG001|Baseline|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
11165069|NCT01967147|BG002|Baseline|Total|Total of all reporting groups
11165070|NCT01967147|FG000|Participant Flow|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
11165071|NCT01967147|FG001|Participant Flow|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
11165072|NCT01967147|OG000|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
11165073|NCT01967147|OG001|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
11165074|NCT01967147|EG000|Reported Event|Pretreatment|All subjects prior to exposure to investigational product
11165075|NCT01967147|EG001|Reported Event|Systane Balance|All subjects exposed to Systane® Balance
11165076|NCT01967147|EG002|Reported Event|Saline|All subjects exposed to Saline
11165077|NCT01967173|BG000|Baseline|Crossover Sequence 1|"Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg~Flovent Diskus® 100 mcg: Flovent is an ICS~Flovent Diskus® 250 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165078|NCT01967173|BG001|Baseline|Crossover Sequence 2|"Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg~Flovent Diskus® 100 mcg: Flovent is an ICS~Flovent Diskus® 250 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165079|NCT01967173|BG002|Baseline|Crossover Sequence 3|"Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg~Flovent Diskus® 100 mcg: Flovent is an ICS~Flovent Diskus® 250 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165080|NCT01967173|BG003|Baseline|Crossover Sequence 4|"Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg~Flovent Diskus® 100 mcg: Flovent is an ICS~Flovent Diskus® 250 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165081|NCT01967173|BG004|Baseline|Crossover Sequence 5|"Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg~Flovent Diskus® 250 mcg: Flovent is an ICS~Flovent Diskus® 500 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165082|NCT01967173|BG005|Baseline|Crossover Sequence 6|"Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg~Flovent Diskus® 250 mcg: Flovent is an ICS~Flovent Diskus® 500 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165083|NCT01967173|BG006|Baseline|Crossover Sequence 7|"Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg~Flovent Diskus® 250 mcg: Flovent is an ICS~Flovent Diskus® 500 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165084|NCT01967173|BG007|Baseline|Crossover Sequence 8|"Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg~Flovent Diskus® 250 mcg: Flovent is an ICS~Flovent Diskus® 500 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165085|NCT01967173|BG008|Baseline|Total|Total of all reporting groups
11165086|NCT01967173|FG000|Participant Flow|Crossover Sequence 1|"Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg~Flovent Diskus® 100 mcg: Flovent is an ICS~Flovent Diskus® 250 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165087|NCT01967173|FG001|Participant Flow|Crossover Sequence 2|"Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg~Flovent Diskus® 100 mcg: Flovent is an ICS~Flovent Diskus® 250 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165088|NCT01967173|FG002|Participant Flow|Crossover Sequence 3|"Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg~Flovent Diskus® 100 mcg: Flovent is an ICS~Flovent Diskus® 250 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165089|NCT01967173|FG003|Participant Flow|Crossover Sequence 4|"Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg~Flovent Diskus® 100 mcg: Flovent is an ICS~Flovent Diskus® 250 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165090|NCT01967173|FG004|Participant Flow|Crossover Sequence 5|"Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg~Flovent Diskus® 250 mcg: Flovent is an ICS~Flovent Diskus® 500 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165091|NCT01967173|FG005|Participant Flow|Crossover Sequence 6|"Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg~Flovent Diskus® 250 mcg: Flovent is an ICS~Flovent Diskus® 500 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165092|NCT01967173|FG006|Participant Flow|Crossover Sequence 7|"Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg~Flovent Diskus® 250 mcg: Flovent is an ICS~Flovent Diskus® 500 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165093|NCT01967173|FG007|Participant Flow|Crossover Sequence 8|"Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg~Flovent Diskus® 250 mcg: Flovent is an ICS~Flovent Diskus® 500 mcg: Flovent is an ICS~Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination~Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination"
11165094|NCT01967173|OG000|Outcome|Adolescents and Adults|All study participant age 12 years or greater
11165095|NCT01967173|OG001|Outcome|Children|All study participants under age 12 years
11165096|NCT01967173|EG000|Reported Event|Flovent 250 in Pediatric Group|Flovent 250 in participants under 12 years
11165097|NCT01967173|EG001|Reported Event|Advair 250/50 in Pediatric Group|Advair 250/50 in participants under 12 years
11165098|NCT01967173|EG002|Reported Event|Flovent 100 in Pediatric Group|Flovent 100 in participants under 12 years
11165099|NCT01967173|EG003|Reported Event|Advair 100/50 in Pediatric Group|Advair 100/50 in participants under 12 years
11165100|NCT01967173|EG004|Reported Event|Flovent 500 in Adolescent/Adult Group|Flovent 500 in participants 12 years and older
11165101|NCT01967173|EG005|Reported Event|Advair 250/50 in Adolescent/Adult Group|Advair 250/50 in participants 12 years and older
11165102|NCT01967173|EG006|Reported Event|Flovent 250 in Adolescent/Adult Group|Flovent 250 in participants 12 years and older
11165103|NCT01967173|EG007|Reported Event|Advair 100/50 in Adolescent/Adult Group|Advair 100/50 in participants 12 years and older
11165104|NCT01967225|BG000|Baseline|Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI|Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
11165105|NCT01967225|BG001|Baseline|Linezoid - SSTI|Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
11165106|NCT01967225|BG002|Baseline|Tedizolid Phosphate (Sivextro, BAY1192631) - Bacteremia|Participants who had SSTI-related bacteremia at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
11165107|NCT01967225|BG003|Baseline|Linezoid - Bacteremia|Participants who had SSTI-related bacteremia at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
11165108|NCT01967225|BG004|Baseline|Total|Total of all reporting groups
11165109|NCT01967225|FG000|Participant Flow|Tedizolid Phosphate (Sivextro, BAY1192631)|Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
11165110|NCT01967225|FG001|Participant Flow|Linezolid|Participants received 600 mg Linezolid solution or tablet twice daily, every 12 +- 3 hours (intravenous (I.V.) or oral (PO))
11165111|NCT01967225|OG000|Outcome|Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI|Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
11165112|NCT01967225|OG001|Outcome|Linezoid - SSTI|Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
11165113|NCT01967225|OG002|Outcome|Tedizolid Phosphate (Sivextro, BAY1192631) - Bacteremia|Participants who had SSTI-related bacteremia at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
11165114|NCT01967225|OG003|Outcome|Linezoid - Bacteremia|Participants who had SSTI-related bacteremia at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
11165115|NCT01967225|EG000|Reported Event|Tedizolid Phosphate (Sivextro, BAY1192631)|Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
11165116|NCT01967225|EG001|Reported Event|Linezolid|Participants received 600 mg Linezolid solution or tablet twice daily, every 12 +- 3 hours (intravenous (I.V.) or oral (PO))
11165117|NCT01967277|BG000|Baseline|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
11165118|NCT01967277|BG001|Baseline|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
11165119|NCT01967277|BG002|Baseline|Total|Total of all reporting groups
11165120|NCT01967277|FG000|Participant Flow|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
11165121|NCT01967277|FG001|Participant Flow|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
11165122|NCT01967277|OG000|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
11165123|NCT01967277|OG001|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
11165124|NCT01967277|EG000|Reported Event|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
11165125|NCT01967277|EG001|Reported Event|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
11165126|NCT01967342|BG000|Baseline|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
11165127|NCT01967342|BG001|Baseline|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
11165128|NCT01967342|BG002|Baseline|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
11165129|NCT01967342|BG003|Baseline|Total|Total of all reporting groups
11165130|NCT01967342|FG000|Participant Flow|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
11165131|NCT01967342|FG001|Participant Flow|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
11165132|NCT01967342|FG002|Participant Flow|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
11165133|NCT01967342|OG000|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
11165134|NCT01967342|OG001|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
11165135|NCT01967342|OG002|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
11165136|NCT01967342|EG000|Reported Event|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
11165137|NCT01967342|EG001|Reported Event|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
11165138|NCT01967342|EG002|Reported Event|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
11165139|NCT01967433|BG000|Baseline|Diphenhydramine|Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives
11165140|NCT01967433|BG001|Baseline|Placebo|0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives
11165141|NCT01967433|BG002|Baseline|Total|Total of all reporting groups
11165142|NCT01967433|FG000|Participant Flow|Diphenhydramine|"Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives~Diphenhydramine Allocated: 61 Lost to follow up: 0 Analyzed: 61"
11165143|NCT01967433|FG001|Participant Flow|Placebo|"0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives~Placebo Allocated: 59 Lost to follow up: 0 Analyzed: 58"
11165144|NCT01967433|OG000|Outcome|Diphenhydramine|"Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives~Diphenhydramine"
11165145|NCT01967433|OG001|Outcome|Placebo|"0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives~Placebo"
11165146|NCT01967433|OG000|Outcome|Diphenhydramine|"Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives~Diphenhydramine Allocated: 61 Lost to follow up: 0 Analyzed: 61"
11165147|NCT01967433|OG001|Outcome|Placebo|"0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives~Placebo Allocated: 59 Lost to follow up: 0 Analyzed: 58"
11165148|NCT01967433|OG000|Outcome|Diphenhydramine|Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives
11165149|NCT01967433|OG001|Outcome|Placebo|0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives
11165150|NCT01967433|OG000|Outcome|Placebo|"0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives~Placebo"
11165151|NCT01967433|OG001|Outcome|Diphenhydramine|"Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives~Diphenhydramine"
11165152|NCT01967433|EG000|Reported Event|Diphenhydramine|Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives
11165153|NCT01967433|EG001|Reported Event|Placebo|0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives
11165154|NCT01967537|BG000|Baseline|68Gallium DOTATATE Imaging|"68Gallium DOTATATE imaging~68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.~Radio-guided surgery: Using 68Gallium DOTATATE"
11165155|NCT01967537|FG000|Participant Flow|68Gallium DOTATATE Imaging|"68Gallium DOTATATE imaging~68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.~Radio-guided surgery: Using 68Gallium DOTATATE"
11165156|NCT01967537|OG000|Outcome|68Gallium DOTATATE Imaging|"68Gallium DOTATATE imaging~68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.~Radio-guided surgery: Using 68Gallium DOTATATE"
11165157|NCT01967537|EG000|Reported Event|68Gallium DOTATATE Imaging|"68Gallium DOTATATE imaging~68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.~Radio-guided surgery: Using 68Gallium DOTATATE"
11165158|NCT01967550|BG000|Baseline|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
11165159|NCT01967550|BG001|Baseline|Placebo|Vehicle control
11165160|NCT01967550|BG002|Baseline|Total|Total of all reporting groups
11165161|NCT01967550|FG000|Participant Flow|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
11165162|NCT01967550|FG001|Participant Flow|Placebo|Vehicle control
11165163|NCT01967550|OG000|Outcome|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
11165164|NCT01967550|OG001|Outcome|Placebo|Vehicle control
11165165|NCT01967550|EG000|Reported Event|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
11165166|NCT01967550|EG001|Reported Event|Placebo|Vehicle control
11165167|NCT01967576|BG000|Baseline|1/Arm 1-Axitinib|"Axitinib 5 mg twice a day on a 28-day cycle~Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle."
11165168|NCT01967576|FG000|Participant Flow|1/Arm 1-Axitinib|"Axitinib 5 mg twice a day on a 28-day cycle~Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle."
11165169|NCT01967576|OG000|Outcome|1/Arm 1-Axitinib|"Axitinib 5 mg twice a day on a 28-day cycle~Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle."
11165170|NCT01967576|EG000|Reported Event|1/Arm 1-Axitinib|"Axitinib 5 mg twice a day on a 28-day cycle~Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle."
11165171|NCT01967628|BG000|Baseline|Vitamin D ASL|Analysis of airway surface liquid in those taking Vitamin D
11165172|NCT01967628|BG001|Baseline|Placebo ASL|Analysis of airway surface liquid in those taking placebo.
11165173|NCT01967628|BG002|Baseline|Total|Total of all reporting groups
11165174|NCT01967628|FG000|Participant Flow|Vitamin D3|"Vitamin D3 (1000 IUs) daily for 3 months.~Vitamin D3 (cholecalciferol)"
11165175|NCT01967628|FG001|Participant Flow|Sugar Capsule|"Placebo comparator made of sugar in a capsule~Placebo Sugar Pill"
11165176|NCT01967628|OG000|Outcome|Vitamin D3|Vitamin D3 (cholecalciferol) at 1000 international units daily for 3 months
11165177|NCT01967628|OG001|Outcome|Sugar Capsule|"Placebo comparator made of sugar in a capsule~Placebo Sugar Pill"
11165178|NCT01967628|EG000|Reported Event|Vitamin D Airway Surface Liquid|Analysis of airway surface liquid in those taking Vitamin D
11165179|NCT01967628|EG001|Reported Event|Placebo Airway Surface Liquid|Analysis of airway surface liquid in those taking placebo.
11165180|NCT01967641|BG000|Baseline|Buprenorphine/Naloxone Combination|Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
11165181|NCT01967641|FG000|Participant Flow|Buprenorphine/Naloxone Combination|Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
11165182|NCT01967641|OG000|Outcome|Buprenorphine/Naloxone Combination|Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
11165183|NCT01967641|OG000|Outcome|Buprenorphine/Naloxone Combination|Thirty-one (31) participants who initiated outpatient phase
11165184|NCT01967641|EG000|Reported Event|Buprenorphine/Naloxone Combination|Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
11165185|NCT01967706|BG000|Baseline|Group 1|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
11165186|NCT01967706|BG001|Baseline|Group 2|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
11165187|NCT01967706|BG002|Baseline|Total|Total of all reporting groups
11165188|NCT01967706|FG000|Participant Flow|mTHS Then mCC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mCC)."
11165189|NCT01967706|FG001|Participant Flow|mCC Then mTHS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS)."
11165190|NCT01967706|FG002|Participant Flow|mTHS Then NRT|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NRT)"
11165191|NCT01967706|FG003|Participant Flow|NRT Then mTHS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NRT)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS)."
11165192|NCT01967706|OG000|Outcome|mTHS - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
11165193|NCT01967706|OG001|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
11165194|NCT01967706|OG002|Outcome|mTHS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
11165195|NCT01967706|OG003|Outcome|NRT - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
11165196|NCT01967706|EG000|Reported Event|Group 1|"This population comprised the subjects that followed these intervention sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
11165197|NCT01967706|EG001|Reported Event|Group 2|"This population comprised the subjects that followed these intervention sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
11165198|NCT01967706|EG002|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
11165199|NCT01967719|BG000|Baseline|Group 1|"This population comprises the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
11165200|NCT01967719|BG001|Baseline|Group 2|"This population comprises the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
11165201|NCT01967719|BG002|Baseline|Total|Total of all reporting groups
11165202|NCT01967719|FG000|Participant Flow|mTHS 2.2 Then mCC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mCC)."
11165203|NCT01967719|FG001|Participant Flow|mCC Then mTHS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS 2.2)."
11165204|NCT01967719|FG002|Participant Flow|mTHS 2.2 Then NNS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NNS)"
11165205|NCT01967719|FG003|Participant Flow|NNS Then mTHS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NNS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS 2.2)."
11165206|NCT01967719|OG000|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
11165207|NCT01967719|OG001|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
11165208|NCT01967719|OG002|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
11165209|NCT01967719|OG003|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
11165210|NCT01967719|OG000|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2."
11165211|NCT01967719|EG000|Reported Event|Group 1|"This population comprises the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
11165212|NCT01967719|EG001|Reported Event|Group 2|"This population comprises the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
11165213|NCT01967719|EG002|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
11165214|NCT01967732|BG000|Baseline|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
11165215|NCT01967732|BG001|Baseline|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
11165216|NCT01967732|BG002|Baseline|Total|Total of all reporting groups
11165217|NCT01967732|FG000|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of CC)."
11165218|NCT01967732|FG001|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
11165219|NCT01967732|FG002|Participant Flow|THS 2.2 Then NNS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NNS)"
11165220|NCT01967732|FG003|Participant Flow|NNS Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NNS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
11165221|NCT01967732|OG000|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
11165222|NCT01967732|OG001|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
11165223|NCT01967732|OG002|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
11165224|NCT01967732|OG003|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
11165225|NCT01967732|EG000|Reported Event|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
11165226|NCT01967732|EG001|Reported Event|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
11165227|NCT01967784|BG000|Baseline|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
11165228|NCT01967784|FG000|Participant Flow|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
11165229|NCT01967784|OG000|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
11165230|NCT01967784|EG000|Reported Event|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
11165231|NCT01967836|BG000|Baseline|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering"
11165232|NCT01967836|FG000|Participant Flow|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing"
11165233|NCT01967836|OG000|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.~Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation~1 subject in ambulatory clinic was approached and was consented"
11165234|NCT01967836|OG000|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.~Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation~1 subject in ambulatory clinic was approached and was consented~Nurses inspection of central line site on study participants at next clinic visit with return of subject patient questionnaire evaluation of use of product device with showing 27 nurse evaluations were completed for analysis"
11165235|NCT01967836|EG000|Reported Event|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing"
11165236|NCT01967862|BG000|Baseline|Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)|"Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.~computed tomography: Undergo CT~bone scan: Undergo bone scan~3-Tesla magnetic resonance imaging: Undergo axial MRI~diffusion-weighted magnetic resonance imaging: Undergo WB MRI~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT~computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT~positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT~laboratory biomarker analysis: Correlative studies"
11165237|NCT01967862|FG000|Participant Flow|Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)|"Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.~computed tomography: Undergo CT~bone scan: Undergo bone scan~3-Tesla magnetic resonance imaging: Undergo axial MRI~diffusion-weighted magnetic resonance imaging: Undergo WB MRI~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT~computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT~positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT~laboratory biomarker analysis: Correlative studies"
11165238|NCT01967862|OG000|Outcome|Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)|"Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.~computed tomography: Undergo CT~bone scan: Undergo bone scan~3-Tesla magnetic resonance imaging: Undergo axial MRI~diffusion-weighted magnetic resonance imaging: Undergo WB MRI~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT~computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT~positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT~laboratory biomarker analysis: Correlative studies"
11165239|NCT01967862|EG000|Reported Event|Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)|"Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.~computed tomography: Undergo CT~bone scan: Undergo bone scan~3-Tesla magnetic resonance imaging: Undergo axial MRI~diffusion-weighted magnetic resonance imaging: Undergo WB MRI~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT~computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT~positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT~laboratory biomarker analysis: Correlative studies"
11165240|NCT01967888|BG000|Baseline|Reparixin|"Solution for intravenous (IV) infusion with active compound~Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour"
11165241|NCT01967888|BG001|Baseline|Placebo|"Physiologic solution~Placebo: Physiologic solution administered at 0.25 mL/kg/hour"
11165242|NCT01967888|BG002|Baseline|Total|Total of all reporting groups
11165243|NCT01967888|FG000|Participant Flow|Reparixin|"Solution for intravenous (IV) infusion with active compound~Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour"
11165244|NCT01967888|FG001|Participant Flow|Placebo|"Physiologic solution~Placebo: Physiologic solution administered at 0.25 mL/kg/hour"
11165245|NCT01967888|OG000|Outcome|Reparixin|"Solution for intravenous (IV) infusion with active compound~Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour"
11165246|NCT01967888|OG001|Outcome|Placebo|"Physiologic solution~Placebo: Physiologic solution administered at 0.25 mL/kg/hour"
11165247|NCT01967888|EG000|Reported Event|Reparixin|"Solution for intravenous (IV) infusion with active compound~Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour"
11165248|NCT01967888|EG001|Reported Event|Placebo|"Physiologic solution~Placebo: Physiologic solution administered at 0.25 mL/kg/hour"
11165249|NCT01967940|BG000|Baseline|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
11165250|NCT01967940|BG001|Baseline|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
11165251|NCT01967940|BG002|Baseline|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
11165252|NCT01967940|BG003|Baseline|Total|Total of all reporting groups
11165253|NCT01967940|FG000|Participant Flow|Part 1 Sentinel Cohort TAF|Tenofovir alafenamide (TAF) 25 mg tablet once daily + their current failing regimen for 10 days
11165254|NCT01967940|FG001|Participant Flow|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
11165255|NCT01967940|FG002|Participant Flow|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
11165256|NCT01967940|FG003|Participant Flow|Part 2 E/C/F/TAF + ATV|Following a 14 day washout period, participants from the Randomized Cohort TAF group who had a > 0.5 log10 decline in HIV-1 RNA and participants from the Randomized Cohort Placebo group were eligible to receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) single-tablet regimen (STR) plus atazanavir (ATV) 300 mg once daily for 48 weeks. After completion of Part 2, all participants were eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF became commercially available, or until Gilead Sciences terminated development of E/C/F/TAF in the applicable country.
11165257|NCT01967940|OG000|Outcome|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
11165258|NCT01967940|OG001|Outcome|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
11165259|NCT01967940|OG002|Outcome|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
11165260|NCT01967940|OG000|Outcome|Part 2 E/C/F/TAF + ATV|E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
11165261|NCT01967940|EG000|Reported Event|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
11165262|NCT01967940|EG001|Reported Event|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
11165263|NCT01967940|EG002|Reported Event|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
11165264|NCT01967940|EG003|Reported Event|Part 2 E/C/F/TAF + ATV|E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks plus the extension phase
11165265|NCT01968031|BG000|Baseline|Placebo|"Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Placebo: Placebo"
11165266|NCT01968031|BG001|Baseline|Istradefylline 20 mg/Day|"Istradefylline 20 mg and placebo to match istradefylline 40 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Istradefylline 20 mg: Istradefylline 20 mg and placebo~Placebo: Placebo"
11165267|NCT01968031|BG002|Baseline|Istradefylline 40 mg/Day|"Istradefylline 40 mg and placebo to match istradefylline 20 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Istradefylline 40 mg: Istradefylline 40 mg and placebo~Placebo: Placebo"
11165268|NCT01968031|BG003|Baseline|Total|Total of all reporting groups
11165269|NCT01968031|FG000|Participant Flow|Placebo|"Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Placebo: Placebo"
11165270|NCT01968031|FG001|Participant Flow|Istradefylline 20 mg/Day|"Istradefylline 20 mg and placebo to match istradefylline 40 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Istradefylline 20 mg: Istradefylline 20 mg and placebo~Placebo: Placebo"
11165271|NCT01968031|FG002|Participant Flow|Istradefylline 40 mg/Day|"Istradefylline 40 mg and placebo to match istradefylline 20 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Istradefylline 40 mg: Istradefylline 40 mg and placebo~Placebo: Placebo"
11165272|NCT01968031|OG000|Outcome|Placebo|"Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Placebo: Placebo"
11165273|NCT01968031|OG001|Outcome|Istradefylline 20 mg/Day|"Istradefylline 20 mg and placebo to match istradefylline 40 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Istradefylline 20 mg: Istradefylline 20 mg and placebo~Placebo: Placebo"
11165274|NCT01968031|OG002|Outcome|Istradefylline 40 mg/Day|"Istradefylline 40 mg and placebo to match istradefylline 20 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Istradefylline 40 mg: Istradefylline 40 mg and placebo~Placebo: Placebo"
11165275|NCT01968031|EG000|Reported Event|Placebo|"Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Placebo: Placebo"
11165276|NCT01968031|EG001|Reported Event|Istradefylline 20 mg/Day|"Istradefylline 20 mg and placebo to match istradefylline 40 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Istradefylline 20 mg: Istradefylline 20 mg and placebo~Placebo: Placebo"
11165277|NCT01968031|EG002|Reported Event|Istradefylline 40 mg/Day|"Istradefylline 40 mg and placebo to match istradefylline 20 mg:~A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.~Istradefylline 40 mg: Istradefylline 40 mg and placebo~Placebo: Placebo"
11165278|NCT01968057|BG000|Baseline|Baricitinib + Ciclosporin|"4 mg baricitinib administered orally on Day 1 of Period 1.~4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2."
11165279|NCT01968057|FG000|Participant Flow|Baricitinib + Ciclosporin|"4 milligrams (mg) baricitinib administered orally on Day 1 of Period 1.~4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2."
11165280|NCT01968057|OG000|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
11165281|NCT01968057|OG001|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
11165282|NCT01968057|EG000|Reported Event|Baricitinib|"4 mg baricitinib administered orally on Day 1 of Period 1.~Adverse events are reported from baseline through predose on Day 4."
11165283|NCT01968057|EG001|Reported Event|Baricitinib + Ciclosporin|"4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.~Adverse events are reported from postdose on Day 4 up to Day 14."
11165284|NCT01968070|BG000|Baseline|Cohort 1 Sequence 1|"Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;"
11165285|NCT01968070|BG001|Baseline|Cohort 1 Sequence 2|"Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;"
11228466|NCT02390908|OG002|Outcome|Site 3 Immediate PLUS Intervention|"Site 3 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228467|NCT02390908|OG003|Outcome|Wait-list PLUS Condition|"Received the PLUS intervention at 12 months post baseline~Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention."
11228468|NCT02390908|OG004|Outcome|No-Treatment Control EMR Group|120 matched patients in the No-Treatment Control Group whose Viral Load results were obtained through Electronic Medical Records (EMR)
11228469|NCT02390908|OG000|Outcome|Site 1 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228470|NCT02390908|OG001|Outcome|Site 2 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228471|NCT02390908|OG002|Outcome|Site 3 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228472|NCT02390908|OG003|Outcome|Wait-list PLUS Condition|"Received the PLUS intervention at 12 months post-baseline~PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.~Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention."
11228473|NCT02390908|OG004|Outcome|No-Treatment EMR Control Group|"The EMRs of randomly selected patients who belonged to the TAU site and were not enrolled in the PLUS trial were matched on key patient characteristics for comparisons with EMRs of patients in the PLUS intervention and Waitlist control conditions. This matched cohort of patients received care at a fourth clinic that did not receive any intervention (i.e., PLUS or eTAU) and was considered as a natural history comparison group.~This group were only included in analyses comparing VL and CD4."
11228474|NCT02390908|EG000|Reported Event|Site 1 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228475|NCT02390908|EG001|Reported Event|Site 2 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228476|NCT02390908|EG002|Reported Event|Site 3 Immediate PLUS Intervention|"Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)~Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence."
11228477|NCT02390908|EG003|Reported Event|Wait-list PLUS Condition|"Received the PLUS intervention at 12 months post baseline~PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.~Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention."
11228478|NCT02390908|EG004|Reported Event|No-Treatment EMR Control Group|Patients not enrolled in PLUS and did not receive the intervention, and were not monitored for adverse events (and thus, no data exists in this regard).
11228479|NCT02391038|BG000|Baseline|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
11228480|NCT02391038|FG000|Participant Flow|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
11228481|NCT02391038|FG001|Participant Flow|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
11228482|NCT02391038|FG002|Participant Flow|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
11165286|NCT01968070|BG002|Baseline|Cohort 1 Sequence 3|"Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;"
11165287|NCT01968070|BG003|Baseline|Cohort 2 Sequence 1|"Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;"
11165288|NCT01968070|BG004|Baseline|Cohort 2 Sequence 2|"Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;"
11165289|NCT01968070|BG005|Baseline|Cohort 2 Sequence 3|"Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;"
11165290|NCT01968070|BG006|Baseline|Cohort 3 LY3127760 60mg|Participants received 60mg LY3127760 capsules orally once daily.
11165291|NCT01968070|BG007|Baseline|Cohort 3 Placebo|Participants received placebo capsules orally once daily.
11165292|NCT01968070|BG008|Baseline|Cohort 3 Celecoxib 400mg|Participants received 400mg Celecoxib capsules orally once daily.
11165293|NCT01968070|BG009|Baseline|Cohort 4 LY3127760 200mg|Participants received 200mg LY3127760 capsules orally once daily.
11165294|NCT01968070|BG010|Baseline|Cohort 4 Placebo|Participants received placebo capsules orally once daily.
11165295|NCT01968070|BG011|Baseline|Cohort 4 Celcoxib 400mg|Participants received 400mg Celecoxib capsules orally once daily.
11165296|NCT01968070|BG012|Baseline|Cohort 5 LY3127760 20mg|Participants received 20mg LY3127760 capsules orally once daily.
11165297|NCT01968070|BG013|Baseline|Cohort 5 Placebo|Participants received placebo capsules orally once daily.
11165298|NCT01968070|BG014|Baseline|Cohort 5 Celecoxib 400mg|Participants received 400mg Celecoxib capsules orally once daily.
11165299|NCT01968070|BG015|Baseline|Cohort 6 LY3127760 300mg|Participants received 300mg LY3127760 capsules orally twice daily.
11165300|NCT01968070|BG016|Baseline|Cohort 6 Placebo|Participants received placebo capsules orally once daily.
11165301|NCT01968070|BG017|Baseline|Cohort 6 Celecoxib 400mg|Participants received 400mg Celecoxib capsules orally once daily.
11165302|NCT01968070|BG018|Baseline|Total|Total of all reporting groups
11165303|NCT01968070|FG000|Participant Flow|Cohort 1 Sequence 1|"Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;"
11165304|NCT01968070|FG001|Participant Flow|Cohort 1 Sequence 2|"Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;"
11165305|NCT01968070|FG002|Participant Flow|Cohort 1 Sequence 3|"Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;"
11165306|NCT01968070|FG003|Participant Flow|Cohort 2 Sequence 1|"Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;"
11165307|NCT01968070|FG004|Participant Flow|Cohort 2 Sequence 2|"Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;"
11165308|NCT01968070|FG005|Participant Flow|Cohort 2 Sequence 3|"Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.~Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;"
11165309|NCT01968070|FG006|Participant Flow|Cohort 3 LY3127760 60mg|Participants received 60mg LY3127760 capsules orally once daily.
11165310|NCT01968070|FG007|Participant Flow|Cohort 3 Placebo|Participants received placebo capsules orally once daily.
11165311|NCT01968070|FG008|Participant Flow|Cohort 3 Celecoxib 400mg|Participants received 400mg Celecoxib capsules orally once daily.
11165312|NCT01968070|FG009|Participant Flow|Cohort 4 LY3127760 200mg|Participants received 200mg LY3127760 capsules orally once daily.
11165313|NCT01968070|FG010|Participant Flow|Cohort 4 Placebo|Participants received placebo capsules orally once daily.
11165314|NCT01968070|FG011|Participant Flow|Cohort 4 Celcoxib 400mg|Participants received 400mg Celecoxib capsules orally once daily.
11165315|NCT01968070|FG012|Participant Flow|Cohort 5 LY3127760 20mg|Participants received 20mg LY3127760 capsules orally once daily.
11165316|NCT01968070|FG013|Participant Flow|Cohort 5 Placebo|Participants received placebo capsules orally once daily.
11165317|NCT01968070|FG014|Participant Flow|Cohort 5 Celecoxib 400mg|Participants received 400mg Celecoxib capsules orally once daily.
11165318|NCT01968070|FG015|Participant Flow|Cohort 6 LY3127760 600mg|Participants received 300mg LY3127760 capsules orally twice daily.
11165319|NCT01968070|FG016|Participant Flow|Cohort 6 Placebo|Participants received placebo capsules orally once daily.
11165320|NCT01968070|FG017|Participant Flow|Cohort 6 Celecoxib 400mg|Participants received 400mg Celecoxib capsules orally once daily.
11165321|NCT01968070|OG000|Outcome|Part 1: Placebo|Placebo, Single Dose Administered PO
11165322|NCT01968070|OG001|Outcome|Part 1: 20 mg LY3127760|20 mg LY3127760 Single Dose Administered PO
11165323|NCT01968070|OG002|Outcome|Part 1: 60 mg LY3127760|60 mg LY3127760 Single Dose Administered PO
11165324|NCT01968070|OG003|Outcome|Part 1: 200 mg LY3127760|200 mg LY3127760 Single Dose Administered PO
11165325|NCT01968070|OG004|Outcome|Part 1: 600 mg LY3127760|600 mg LY3127760 Single Dose Administered PO
11165326|NCT01968070|OG005|Outcome|Part 1: 600 mg LY3127760 (Fasted)|600 mg LY3127760 Single Dose Administered PO During Fasted State
11165327|NCT01968070|OG006|Outcome|Part 1: 900 mg LY3127760|900 mg LY3127760 Single Dose Administered PO
11165328|NCT01968070|OG007|Outcome|Part 2: Placebo|Placebo administered PO, once a day (QD), for 28 days.
11165329|NCT01968070|OG008|Outcome|Part 2: 20 mg LY3127760|20 mg LY3127760 administered PO, QD, for 28 days.
11165330|NCT01968070|OG009|Outcome|Part 2: 60 mg LY3127760|60 mg LY3127760 administered PO, QD, for 28 days.
11165331|NCT01968070|OG010|Outcome|Part 2: 200 mg LY3127760|200 mg LY3127760 administered PO, QD, for 28 days.
11165332|NCT01968070|OG011|Outcome|Part 2: 300 mg LY3127760|300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
11165333|NCT01968070|OG012|Outcome|Part 2: 400 mg Celecoxib|Celecoxib administered PO, QD, for 28 days.
11165334|NCT01968070|OG000|Outcome|Part 1: 20 mg LY3127760|20 mg LY3127760 Single Dose Administered PO
11165335|NCT01968070|OG001|Outcome|Part 1: 60 mg LY3127760|60 mg LY3127760 Single Dose Administered PO
11165336|NCT01968070|OG002|Outcome|Part 1: 200 mg LY3127760|200 mg LY3127760 Single Dose Administered PO
11165337|NCT01968070|OG003|Outcome|Part 1: 600 mg LY3127760|600 mg LY3127760 Single Dose Administered PO
11165338|NCT01968070|OG004|Outcome|Part 1: 600 mg LY3127760 (Fasted)|600 mg LY3127760 Single Dose Administered PO During a Fasted State
11165339|NCT01968070|OG005|Outcome|Part 1: 900 mg LY3127760|900 mg LY3127760 Single Dose Administered PO
11165340|NCT01968070|OG000|Outcome|Part 2: 20 mg LY3127760|20 mg LY3127760 Administered QD PO, Day 1-28
11165341|NCT01968070|OG001|Outcome|Part 2: 60 mg LY3127760|60 mg LY3127760 Administered QD PO, Day 1-28
11165342|NCT01968070|OG002|Outcome|Part 2: 200 mg LY3127760|200 mg LY3127760 Administered QD PO, Day 1-28
11165343|NCT01968070|OG003|Outcome|Part 2: 300 mg LY3127760|300 mg LY3127760 Administered BID PO, Day 1-28
11165344|NCT01968070|EG000|Reported Event|Placebo (Part 1)|Placebo, Single Dose Administered PO
11165345|NCT01968070|EG001|Reported Event|20 mg LY3127760 (Part 1)|20 mg LY3127760 Single Dose Administered PO
11165346|NCT01968070|EG002|Reported Event|60 mg LY3127760 (Part 1)|60 mg LY3127760 Single Dose Administered PO
11165347|NCT01968070|EG003|Reported Event|200 mg LY3127760 (Part 1)|200 mg LY3127760 Single Dose Administered PO
11165348|NCT01968070|EG004|Reported Event|600 mg LY3127760 (Part 1)|600 mg LY3127760 Single Dose Administered PO
11165349|NCT01968070|EG005|Reported Event|600 mg LY3127760 (Fasted) (Part 1)|600 mg LY3127760 Single Dose Administered PO During Fasted State
11165350|NCT01968070|EG006|Reported Event|900 mg LY3127760 (Part 1)|900 mg LY3127760 Single Dose Administered PO
11165351|NCT01968070|EG007|Reported Event|Placebo (Part 2)|Placebo, Administered QD PO, Day 1-28
11165352|NCT01968070|EG008|Reported Event|20 mg LY3127760 (Part 2)|20 mg LY3127760 Administered QD PO, Day 1-28
11165353|NCT01968070|EG009|Reported Event|60 mg LY3127760 (Part 2)|60 mg LY3127760 Administered QD PO, Day 1-28
11165354|NCT01968070|EG010|Reported Event|200 mg LY3127760 (Part 2)|200 mg LY3127760 Administered QD PO, Day 1-28
11165355|NCT01968070|EG011|Reported Event|300 mg LY3127760 (Part 2)|300 mg LY3127760 Administered BID PO, Day 1-28
11165356|NCT01968070|EG012|Reported Event|400 mg Celecoxib (Part 2)|400 mg celecoxib Administered QD PO, Day 1-28
11165357|NCT01968135|BG000|Baseline|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
11165358|NCT01968135|BG001|Baseline|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
11165359|NCT01968135|BG002|Baseline|Total|Total of all reporting groups
11165360|NCT01968135|FG000|Participant Flow|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
11165361|NCT01968135|FG001|Participant Flow|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
11165362|NCT01968135|OG000|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
11165363|NCT01968135|OG001|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
11165364|NCT01968135|EG000|Reported Event|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
11165365|NCT01968135|EG001|Reported Event|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
11165366|NCT01968317|BG000|Baseline|Megestrol Acetate and Metformin|"Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.~Megestrol acetate and metformin: Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months."
11165367|NCT01968317|BG001|Baseline|Megestrol Acetate|"Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.~Megestrol acetate: Patients will receive megestrol acetate 160 mg by mouth daily for 3 months."
11165368|NCT01968317|BG002|Baseline|Total|Total of all reporting groups
11165369|NCT01968317|FG000|Participant Flow|Megestrol Acetate and Metformin|"Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.~Megestrol acetate and metformin: Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months."
11165370|NCT01968317|FG001|Participant Flow|Megestrol Acetate|"Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.~Megestrol acetate: Patients will receive megestrol acetate 160 mg by mouth daily for 3 months."
11165371|NCT01968317|OG000|Outcome|Megestrol Acetate and Metformin|Patients will receive metformin 500 mg by mouth three times daily and megestrol acetate 160 mg by mouth daily. Hysteroscopic evaluation was performed every 3 months during the therapy to evaluate the endometrial condition, and the findings will be recorded.
11165372|NCT01968317|OG001|Outcome|Megestrol Acetate|Patients will receive megestrol acetate 160 mg by mouth daily. Hysteroscopic evaluation was performed every 3 months during the therapy to evaluate the endometrial condition, and the findings will be recorded.
11228483|NCT02391038|OG000|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
11228484|NCT02391038|OG000|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
11228485|NCT02391038|OG001|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
11228486|NCT02391038|OG002|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
11228487|NCT02391038|OG000|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
11228488|NCT02391038|OG000|Outcome|Phase 2: All Participants|MLN0264, injection, intravenously on Day 1 of 3 week cycles of Phase 2, until disease progression or unacceptable toxicity. Dosage for this phase was determined from results of Phase 1 MTD/RP2D.
11228489|NCT02391038|EG000|Reported Event|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
11228490|NCT02391116|BG000|Baseline|Copanlisib (Aliqopa, BAY80-6946)|Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
11228491|NCT02391116|FG000|Participant Flow|Copanlisib (Aliqopa, BAY80-6946)|Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
11228492|NCT02391116|OG000|Outcome|Copanlisib (Aliqopa, BAY80-6946)|Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
11228493|NCT02391116|OG000|Outcome|CD79b Mutant|Included all participants with CD79b mutant classified at baseline depending on the biomarker value
11228494|NCT02391116|OG001|Outcome|CD79b Wild-type|Included all participants with CD79b wild-type classified at baseline depending on biomarker value
11228495|NCT02391116|OG002|Outcome|CD79b Status Missing|Included all participants with CD79b status missing at baseline
11228496|NCT02391116|OG000|Outcome|Activated B-cell-like (ABC)|Included all participants with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value
11228497|NCT02391116|OG001|Outcome|Germinal Center B-cell-like (GCB)|Included all participants with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value
11228498|NCT02391116|OG002|Outcome|Unclassifiable|Included all participants with unclassifiable DLBCL/COO subtype at baseline
11228499|NCT02391116|OG003|Outcome|DLBCL/COO Subtype Missing|Included all participants with DLBCL/COO subtype missing at baseline
11228500|NCT02391116|EG000|Reported Event|Copanlisib (Aliqopa, BAY80-6946)|Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
11228501|NCT02391311|BG000|Baseline|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
11228502|NCT02391311|BG001|Baseline|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
11228503|NCT02391311|BG002|Baseline|Total|Total of all reporting groups
11228504|NCT02391311|FG000|Participant Flow|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
11165373|NCT01968317|EG000|Reported Event|Megestrol Acetate and Metformin|Patients will receive metformin 500 mg by mouth three times daily and megestrol acetate 160 mg by mouth daily. After initiating the treatment, hysteroscopic evaluation was performed every 3 months during the therapy to evaluate the endometrial condition, and the findings will be recorded.
11165374|NCT01968317|EG001|Reported Event|Megestrol Acetate|Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.After initiating the treatment, hysteroscopic evaluation was performed every 3 months during the therapy to evaluate the endometrial condition, and the findings will be recorded.
11165375|NCT01968356|BG000|Baseline|3M CHG/IPA Prep Colorless Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165376|NCT01968356|BG001|Baseline|3M CHG/IPA Prep Tint Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Tint: Apply topically."
11165377|NCT01968356|BG002|Baseline|ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically."
11165378|NCT01968356|BG003|Baseline|Normal Saline Abdominal Region|"0.9% normal saline with applicator~Normal Saline: Apply topically."
11165379|NCT01968356|BG004|Baseline|3M CHG/IPA Prep Colorless Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165380|NCT01968356|BG005|Baseline|3M CHG/IPA Prep Tint Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165381|NCT01968356|BG006|Baseline|ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically."
11165382|NCT01968356|BG007|Baseline|Normal Saline Inguinal Region|"0.9% normal saline with applicator~Normal Saline: Apply topically."
11165383|NCT01968356|BG008|Baseline|Total|Total of all reporting groups
11165384|NCT01968356|FG000|Participant Flow|3M CHG/IPA Prep Colorless Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165385|NCT01968356|FG001|Participant Flow|3M CHG/IPA Prep Tint Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Tint: Apply topically."
11165386|NCT01968356|FG002|Participant Flow|ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically."
11165387|NCT01968356|FG003|Participant Flow|Normal Saline Abdominal Region|"0.9% normal saline with applicator~Normal Saline: Apply topically."
11165388|NCT01968356|FG004|Participant Flow|3M CHG/IPA Prep Colorless Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165389|NCT01968356|FG005|Participant Flow|3M CHG/IPA Prep Tint Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165390|NCT01968356|FG006|Participant Flow|ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically."
11165391|NCT01968356|FG007|Participant Flow|Normal Saline Inguinal Region|"0.9% normal saline with applicator~Normal Saline: Apply topically."
11165392|NCT01968356|OG000|Outcome|3M CHG/IPA Prep Colorless Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165393|NCT01968356|OG001|Outcome|3M CHG/IPA Prep Tint Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Tint: Apply topically."
11165394|NCT01968356|OG002|Outcome|ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically."
11165395|NCT01968356|OG003|Outcome|Normal Saline Abdominal Region|"0.9% normal saline with applicator~Normal Saline: Apply topically."
11165396|NCT01968356|OG004|Outcome|3M CHG/IPA Prep Colorless Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165397|NCT01968356|OG005|Outcome|3M CHG/IPA Prep Tint Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165398|NCT01968356|OG006|Outcome|ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically."
11165399|NCT01968356|OG007|Outcome|Normal Saline Inguinal Region|"0.9% normal saline with applicator~Normal Saline: Apply topically."
11165400|NCT01968356|OG000|Outcome|3M CHG/IPA Prep Colorless - Abdominal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the abdominal region for 30 seconds~3M CHG/IPA Prep Tint: Apply topically.~ChloraPrep: Apply topically.~Saline: Apply topically."
11165401|NCT01968356|OG001|Outcome|3M CHG/IPA Prep Tint - Abdominal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the abdominal region for 30 seconds~3M CHG/IPA Prep Colorless: Apply topically.~ChloraPrep: Apply topically.~Saline: Apply topically."
11165402|NCT01968356|OG002|Outcome|ChloraPrep Hi-Lite Orange - Abdominal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the abdominal region for 30 seconds~3M CHG/IPA Prep Colorless: Apply topically.~3M CHG/IPA Prep Tint: Apply topically.~Saline: Apply topically."
11165403|NCT01968356|OG003|Outcome|Normal Saline - Abdominal|"0.9% normal saline applied topically to the abdominal region with applicator for 30 seconds~3M CHG/IPA Prep Colorless: Apply topically.~3M CHG/IPA Prep Tint: Apply topically.~ChloraPrep: Apply topically."
11165404|NCT01968356|OG004|Outcome|3M CHG/IPA Prep Colorless - Inguinal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the inguinal region for 2 minutes~3M CHG/IPA Prep Tint: Apply topically.~ChloraPrep: Apply topically.~Saline: Apply topically."
11165405|NCT01968356|OG005|Outcome|3M CHG/IPA Prep Tint - Inguinal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the inguinal region for 2 minutes~3M CHG/IPA Prep Colorless: Apply topically.~ChloraPrep: Apply topically.~Saline: Apply topically."
11165406|NCT01968356|OG006|Outcome|ChloraPrep Hi-Lite Orange - Inguinal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the inguinal region for 2 minutes~3M CHG/IPA Prep Colorless: Apply topically.~3M CHG/IPA Prep Tint: Apply topically.~Saline: Apply topically."
11165407|NCT01968356|OG007|Outcome|Normal Saline - Inguinal|"0.9% normal saline applied topically to the inguinal region with applicator for 2 minutes~3M CHG/IPA Prep Colorless: Apply topically.~3M CHG/IPA Prep Tint: Apply topically.~ChloraPrep: Apply topically."
11165408|NCT01968356|EG000|Reported Event|3M CHG/IPA Prep Tint Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Tint: Apply topically."
11165409|NCT01968356|EG001|Reported Event|3M CHG/IPA Prep Colorless Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165410|NCT01968356|EG002|Reported Event|ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically."
11165411|NCT01968356|EG003|Reported Event|Normal Saline Abdominal Region|"0.9% normal saline with applicator~Normal Saline: Apply topically."
11165412|NCT01968356|EG004|Reported Event|3M CHG/IPA Prep Colorless Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165413|NCT01968356|EG005|Reported Event|3M CHG/IPA Prep Tint Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~3M CHG/IPA Prep Colorless: Apply topically."
11165414|NCT01968356|EG006|Reported Event|ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator~ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically."
11165415|NCT01968356|EG007|Reported Event|Normal Saline Inguinal Region|"0.9% normal saline with applicator~Normal Saline: Apply topically."
11165416|NCT01968382|BG000|Baseline|IMM 124-E 2400 mg/Day|"Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.~IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.~Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily"
11165417|NCT01968382|BG001|Baseline|IMM 124-E 4800 mg/Day|"Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.~IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E."
11165418|NCT01968382|BG002|Baseline|Placebo (High Protein Milk Powder)|"Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.~Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily"
11165419|NCT01968382|BG003|Baseline|Total|Total of all reporting groups
11165420|NCT01968382|FG000|Participant Flow|IMM 124-E 2400 mg/Day|"Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.~IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.~Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily"
11165421|NCT01968382|FG001|Participant Flow|IMM 124-E 4800 mg/Day|"Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.~IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E."
11165422|NCT01968382|FG002|Participant Flow|Placebo (High Protein Milk Powder)|"Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.~Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily"
11165423|NCT01968382|OG000|Outcome|IMM 124-E 2400 mg/Day|"Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.~IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.~Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily"
11165424|NCT01968382|OG001|Outcome|IMM 124-E 4800 mg/Day|"Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.~IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E."
11165425|NCT01968382|OG002|Outcome|Placebo (High Protein Milk Powder)|"Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.~Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily"
11165426|NCT01968382|EG000|Reported Event|IMM 124-E 2400 mg/Day|"Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.~IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.~Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily"
11165427|NCT01968382|EG001|Reported Event|IMM 124-E 4800 mg/Day|"Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.~IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E."
11165428|NCT01968382|EG002|Reported Event|Placebo (High Protein Milk Powder)|"Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.~Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily"
11174016|NCT02019277|OG000|Outcome|Trastuzumab, Pertuzumab, and Taxane|Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
11174017|NCT02019277|EG000|Reported Event|Trastuzumab, Pertuzumab, and Taxane|Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
11174018|NCT02019420|BG000|Baseline|Tedizolid|Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
11174019|NCT02019420|BG001|Baseline|Linezolid|Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
11174020|NCT02019420|BG002|Baseline|Total|Total of all reporting groups
11174021|NCT02019420|FG000|Participant Flow|Tedizolid|Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
11174022|NCT02019420|FG001|Participant Flow|Linezolid|Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
11174023|NCT02019420|OG000|Outcome|Tedizolid|Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
11174024|NCT02019420|OG001|Outcome|Linezolid|Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
11174025|NCT02019420|EG000|Reported Event|Tedizolid|Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
11174026|NCT02019420|EG001|Reported Event|Linezolid|Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
11174027|NCT02019472|BG000|Baseline|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
11174028|NCT02019472|BG001|Baseline|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
11174029|NCT02019472|BG002|Baseline|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
11174030|NCT02019472|BG003|Baseline|Total|Total of all reporting groups
11174031|NCT02019472|FG000|Participant Flow|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
11174032|NCT02019472|FG001|Participant Flow|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
11174033|NCT02019472|FG002|Participant Flow|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
11174034|NCT02019472|OG000|Outcome|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
11165429|NCT01968421|BG000|Baseline|OM-85|"The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.~OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year."
11165430|NCT01968421|BG001|Baseline|Placebo|"The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.~OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year."
11165431|NCT01968421|BG002|Baseline|Total|Total of all reporting groups
11165432|NCT01968421|FG000|Participant Flow|OM-85|"The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.~OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year."
11165433|NCT01968421|FG001|Participant Flow|Placebo|"The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.~OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year."
11165434|NCT01968421|OG000|Outcome|OM-85|"The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.~OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year."
11165435|NCT01968421|OG001|Outcome|Placebo|"The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.~OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year."
11165436|NCT01968421|EG000|Reported Event|OM-85|"The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.~OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year."
11165437|NCT01968421|EG001|Reported Event|Placebo|"The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.~OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year."
11165438|NCT01968434|BG000|Baseline|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum in a syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6.5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.~Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
11165439|NCT01968434|BG001|Baseline|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic~Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
11165440|NCT01968434|BG002|Baseline|Total|Total of all reporting groups
11165441|NCT01968434|FG000|Participant Flow|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.~Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
11165442|NCT01968434|FG001|Participant Flow|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic~Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
11165443|NCT01968434|OG000|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
11165444|NCT01968434|OG001|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
11165445|NCT01968434|EG000|Reported Event|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
11165446|NCT01968434|EG001|Reported Event|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
11165447|NCT01968447|BG000|Baseline|Hypocapnia|"arterial pCO2 of 3.5 kPa or 26.3 mmHg~hypocapnia"
11165448|NCT01968447|BG001|Baseline|Normocapnia|"arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg~normocapnia"
11165449|NCT01968447|BG002|Baseline|Total|Total of all reporting groups
11165450|NCT01968447|FG000|Participant Flow|Hypocapnia|"arterial pCO2 of 3.5 kPa or 26.3 mmHg~hypocapnia"
11165451|NCT01968447|FG001|Participant Flow|Normocapnia|"arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg~normocapnia"
11165452|NCT01968447|OG000|Outcome|Hypocapnia|"arterial pCO2 of 3.5 kPa or 26.3 mmHg~hypocapnia"
11165453|NCT01968447|OG001|Outcome|Normocapnia|"arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg~normocapnia"
11165454|NCT01968447|EG000|Reported Event|Hypocapnia|"arterial pCO2 of 3.5 kPa or 26.3 mmHg~hypocapnia"
11165455|NCT01968447|EG001|Reported Event|Normocapnia|"arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg~normocapnia"
11165456|NCT01968551|BG000|Baseline|Cohort 1: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165457|NCT01968551|BG001|Baseline|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165458|NCT01968551|BG002|Baseline|Cohort 2: SBR|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165459|NCT01968551|BG003|Baseline|Total|Total of all reporting groups
11165460|NCT01968551|FG000|Participant Flow|Cohort 1: E/C/F/TAF+DRV|"Open-Label (OL) Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily"
11165461|NCT01968551|FG001|Participant Flow|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165462|NCT01968551|FG002|Participant Flow|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165463|NCT01968551|OG000|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TDF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165464|NCT01968551|OG001|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165465|NCT01968551|OG000|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165466|NCT01968551|OG001|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165467|NCT01968551|OG000|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165468|NCT01968551|OG001|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165469|NCT01968551|EG000|Reported Event|Cohort 1: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165470|NCT01968551|EG001|Reported Event|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165471|NCT01968551|EG002|Reported Event|Cohort 2: SBR|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
11165472|NCT01968551|EG003|Reported Event|All E/C/F/TAF|Open- label or Extension Phase: All participants received E/C/F/TAF.
11165473|NCT01968694|BG000|Baseline|IV Lidocaine Then IV Diphenhydramine|"IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.~IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes."
11165474|NCT01968694|BG001|Baseline|IV Diphenhydramine Then IV Lidocaine|"IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.~IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes."
11165475|NCT01968694|BG002|Baseline|Total|Total of all reporting groups
11165476|NCT01968694|FG000|Participant Flow|IV Lidocaine Then IV Diphenhydramine|"IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.~IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes."
11165477|NCT01968694|FG001|Participant Flow|IV Diphenhydramine Then IV Lidocaine|"IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.~IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes."
11165478|NCT01968694|OG000|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
11165479|NCT01968694|OG001|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
11165480|NCT01968694|EG000|Reported Event|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
11165481|NCT01968694|EG001|Reported Event|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
11165482|NCT01968694|EG002|Reported Event|Washout Period After IV Lidocaine|Washout period after IV Lidocaine before IV diphenhydramine
11165483|NCT01968694|EG003|Reported Event|Washout Period After IV Diphenhydramine|Washout period after IV diphenhydramine before IV Lidocaine
11165484|NCT01968707|BG000|Baseline|ChloraPrep Hi-Lite Orange - Abdominal|ChloraPrep 2% CHG/70% IPA 26-mL applicator applied topically for 30 seconds.
11165485|NCT01968707|BG001|Baseline|Normal Saline - Abdominal|Normal Saline with applicator applied topically for 30 seconds.
11165486|NCT01968707|BG002|Baseline|3M CHG/IPA Prep Tint 10.5-mL - Abdominal|3M CHG/IPA 2% CHG/70% IPA 10.5-mL applicator applied topically for 30 seconds.
11165487|NCT01968707|BG003|Baseline|3M CHG/IPA Prep Tint 26-mL - Abdominal|3M CHG/IPA 2% CHG/70% IPA 26-mL applicator applied topically for 30 seconds.
11165488|NCT01968707|BG004|Baseline|ChloraPrep Hi-Lite Orange - Inguinal|ChloraPrep 2% CHG/70% IPA 26-mL applicator applied topically for 2 minutes.
11165489|NCT01968707|BG005|Baseline|Normal Saline - Inguinal|Normal Saline with applicator applied topically for 2 minutes.
11165490|NCT01968707|BG006|Baseline|3M CHG/IPA Prep Tint 10.5-mL - Inguinal|3M CHG/IPA 2% CHG/70% IPA 10.5-mL applicator applied topically for 2 minutes.
11165491|NCT01968707|BG007|Baseline|3M CHG/IPA Prep 26-mL - Inguinal|3M CHG/IPA 2% CHG/70% IPA 26-mL applicator applied topically for 2 minutes.
11165492|NCT01968707|BG008|Baseline|Total|Total of all reporting groups
11165493|NCT01968707|FG000|Participant Flow|ChloraPrep Hi-Lite Orange - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165494|NCT01968707|FG001|Participant Flow|Normal Saline - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165495|NCT01968707|FG002|Participant Flow|3M CHG/IPA Prep Tint 10.5-mL - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165496|NCT01968707|FG003|Participant Flow|3M CHG/IPA Prep Tint 26-mL - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165497|NCT01968707|FG004|Participant Flow|ChloraPrep Hi-Lite Orange - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165498|NCT01968707|FG005|Participant Flow|Normal Saline - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165499|NCT01968707|FG006|Participant Flow|3M CHG/IPA Prep Tint 10.5-mL - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165500|NCT01968707|FG007|Participant Flow|3M CHG/IPA Prep Tint 26-mL - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165501|NCT01968707|OG000|Outcome|ChloraPrep Hi-Lite Orange - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165502|NCT01968707|OG001|Outcome|3M CHG/IPA Prep Tint 10.5-mL - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165503|NCT01968707|OG002|Outcome|3M CHG/IPA Prep Tint 26-mL - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165504|NCT01968707|OG003|Outcome|Normal Saline - Abdominal|Apply topically to the abdominal region for 30 seconds
11165505|NCT01968707|OG004|Outcome|ChloraPrep Hi-Lite Orange - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165506|NCT01968707|OG005|Outcome|3M CHG/IPA Prep Tint 10.5-mL - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165507|NCT01968707|OG006|Outcome|3M CHG/IPA Prep Tint 26-mL - Inguinal|Applied topically to the inguinal region for 2 minutes
11165508|NCT01968707|OG007|Outcome|Normal Saline - Inguinal|Apply topically to the inguinal region for 2 minutes
11165509|NCT01968707|OG001|Outcome|Normal Saline - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165510|NCT01968707|OG002|Outcome|3M CHG/IPA Prep Tint 10.5-mL - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165511|NCT01968707|OG003|Outcome|3M CHG/IPA Prep Tint 26-mL - Abdominal|Applied topically to the abdominal region for 30 seconds.
11165512|NCT01968707|OG005|Outcome|Normal Saline - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165513|NCT01968707|OG006|Outcome|3M CHG/IPA Prep Tint 10.5-mL - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165514|NCT01968707|OG007|Outcome|3M CHG/IPA Prep Tint 26-mL - Inguinal|Applied topically to the inguinal region for 2 minutes.
11165515|NCT01968707|OG000|Outcome|ChloraPrep Hi-Lite Orange - Abdominal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 26-mL applied topically to the abdominal region for 30 seconds.~ChloraPrep Hi-Lite Orange Tint: Apply topically."
11165516|NCT01968707|OG001|Outcome|Normal Saline - Abdominal|"0.9% normal saline applied topically to the abdominal region for 30 seconds.~Normal Saline: Apply topically."
11165517|NCT01968707|OG002|Outcome|3M CHG/IPA Prep Tint 10.5-mL - Abdominal|"Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 10.5 mL applied topically to the abdominal region for 30 seconds.~3M CHG/IPA Prep Tint 10.5-mL: Apply topically."
11165518|NCT01968707|OG003|Outcome|3M CHG/IPA Prep Tint 26-mL - Abdominal|"Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 26 mL applied topically to the abdominal region for 30 seconds.~3M CHG/IPA Prep Tint 26-mL: Apply topically"
11165519|NCT01968707|OG004|Outcome|ChloraPrep Hi-Lite Orange - Inguinal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 26-mL applied topically to the inguinal region for 2 minutes.~ChloraPrep Hi-Lite Orange Tint: Apply topically."
11165520|NCT01968707|OG005|Outcome|Normal Saline - Inguinal|"0.9% normal saline applied topically to the inguinal region for 2 minutes.~Normal Saline: Apply topically."
11165521|NCT01968707|OG006|Outcome|3M CHG/IPA Prep Tint 10.5-mL - Inguinal|"Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 10.5 mL applied topically to the inguinal region for 2 minutes.~3M CHG/IPA Prep Tint 10.5-mL: Apply topically."
11165522|NCT01968707|OG007|Outcome|3M CHG/IPA Prep Tint 26-mL - Inguinal|"Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 26 mL applied topically to the inguinal region for 2 minutes~3M CHG/IPA Prep Tint 26-mL: Apply topically"
11165523|NCT01968707|OG007|Outcome|3M CHG/IPA Prep Tint 26-mL - Inguinal|Applied topically to the inguinal region for 2 minutes
11165524|NCT01968707|EG000|Reported Event|ChloraPrep Hi-Lite Orange - Abdominal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 26-mL applied topically to the abdominal region for 30 seconds.~ChloraPrep Hi-Lite Orange: Apply topically."
11165525|NCT01968707|EG001|Reported Event|Normal Saline - Abdominal|"0.9% normal saline applied topically to the abdominal region for 30 seconds.~Normal Saline: Apply topically."
11165526|NCT01968707|EG002|Reported Event|3M CHG/IPA Prep Tint 10.5-mL - Abdominal|"Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 10.5 mL applied topically to the abdominal region for 30 seconds.~3M CHG/IPA Prep Tint 10.5-mL: Apply topically."
11165527|NCT01968707|EG003|Reported Event|3M CHG/IPA Prep Tint 26-mL - Abdominal|"Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 26 mL applied topically to the abdominal region for 30 seconds.~3M CHG/IPA Prep Tint 26-mL: Apply topically"
11165528|NCT01968707|EG004|Reported Event|ChloraPrep Hi-Lite Orange - Inguinal|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 26-mL applied topically to the inguinal region for 2 minutes.~ChloraPrep Hi-Lite Orange: Apply topically."
11165529|NCT01968707|EG005|Reported Event|Normal Saline - Inguinal|"0.9% normal saline applied topically to the inguinal region for 2 minutes.~Normal Saline: Apply topically."
11165530|NCT01968707|EG006|Reported Event|3M CHG/IPA Prep Tint 10.5-mL - Inguinal|"Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 10.5 mL applied topically to the inguinal region for 2 minutes.~3M CHG/IPA Prep Tint 10.5-mL: Apply topically."
11165531|NCT01968707|EG007|Reported Event|3M CHG/IPA Prep Tint 26-mL - Inguinal|"Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 26 mL applied topically to the inguinal region for 2 minutes~3M CHG/IPA Prep Tint 26-mL: Apply topically"
11165532|NCT01968811|BG000|Baseline|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
11165533|NCT01968811|FG000|Participant Flow|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
11165534|NCT01968811|OG000|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
11165535|NCT01968811|EG000|Reported Event|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
11165536|NCT01968954|BG000|Baseline|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165537|NCT01968954|BG001|Baseline|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165538|NCT01968954|BG002|Baseline|Total|Total of all reporting groups
11165539|NCT01968954|FG000|Participant Flow|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165540|NCT01968954|FG001|Participant Flow|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165541|NCT01968954|OG000|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165542|NCT01968954|OG001|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165543|NCT01968954|OG000|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165544|NCT01968954|EG000|Reported Event|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165545|NCT01968954|EG001|Reported Event|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165546|NCT01968967|BG000|Baseline|Placebo (Treatment Period)|Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11165547|NCT01968967|BG001|Baseline|Bococizumab 150 mg (Treatment Period)|Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and were followed up to Week 58.
11165548|NCT01968967|BG002|Baseline|Total|Total of all reporting groups
11165549|NCT01968967|FG000|Participant Flow|Placebo (Treatment Period)|Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11165550|NCT01968967|FG001|Participant Flow|Bococizumab 150 mg (Treatment Period)|Participants received Bococizumab (PF-04950615) 150 milligram (mg) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11165551|NCT01968967|FG002|Participant Flow|Placebo (Extension Period)|Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
11165552|NCT01968967|FG003|Participant Flow|Bococizumab ADA Positive (Extension Period)|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11165553|NCT01968967|FG004|Participant Flow|Bococizumab ADA Negative (Extension Period)|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11165554|NCT01968967|OG000|Outcome|Placebo (Treatment Period)|Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11165555|NCT01968967|OG001|Outcome|Bococizumab 150 mg (Treatment Period)|Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11165556|NCT01968967|OG000|Outcome|Bococizumab 150 mg (Treatment Period)|Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11165557|NCT01968967|OG000|Outcome|Placebo (Extension Period)|Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
11165558|NCT01968967|OG001|Outcome|Bococizumab ADA Positive (Extension Period)|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11165559|NCT01968967|OG002|Outcome|Bococizumab ADA Negative (Extension Period)|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11165560|NCT01968967|OG000|Outcome|Bococizumab ADA Positive (Extension Period)|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11165561|NCT01968967|EG000|Reported Event|Placebo (Treatment Period)|Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11165562|NCT01968967|EG001|Reported Event|Bococizumab 150 mg (Treatment Period)|Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and were followed up to Week 58.
11165563|NCT01968967|EG002|Reported Event|Placebo (Extension Period)|Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
11165564|NCT01968967|EG003|Reported Event|Bococizumab ADA Positive (Extension Period)|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11165565|NCT01968967|EG004|Reported Event|Bococizumab ADA Negative (Extension Period)|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11165566|NCT01968980|BG000|Baseline|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165567|NCT01968980|BG001|Baseline|PF--04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165568|NCT01968980|BG002|Baseline|Total|Total of all reporting groups
11165569|NCT01968980|FG000|Participant Flow|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165570|NCT01968980|FG001|Participant Flow|PF--04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165571|NCT01968980|OG000|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165572|NCT01968980|OG001|Outcome|PF--04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165573|NCT01968980|OG000|Outcome|PF--04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165574|NCT01968980|EG000|Reported Event|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165575|NCT01968980|EG001|Reported Event|PF--04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
11165576|NCT01969058|BG000|Baseline|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
11165577|NCT01969058|BG001|Baseline|No Study Treatment Arm|No Isotretinoin treatment
11165578|NCT01969058|BG002|Baseline|Total|Total of all reporting groups
11165579|NCT01969058|FG000|Participant Flow|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
11165580|NCT01969058|FG001|Participant Flow|No Study Treatment Arm|No Isotretinoin treatment
11165581|NCT01969058|OG000|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
11165582|NCT01969058|OG001|Outcome|No Study Treatment Arm|No Isotretinoin treatment
11165583|NCT01969058|EG000|Reported Event|Isotretinoin|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
11165584|NCT01969058|EG001|Reported Event|No Study Treatment|No Isotretinoin treatment
11165585|NCT01969084|BG000|Baseline|Linagliptin|"Subjects given Linagliptin~Linagliptin~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
11165586|NCT01969084|BG001|Baseline|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
11165587|NCT01969084|BG002|Baseline|Total|Total of all reporting groups
11165588|NCT01969084|FG000|Participant Flow|Linagliptin|"Subjects given Linagliptin~Linagliptin~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
11165589|NCT01969084|FG001|Participant Flow|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
11165590|NCT01969084|OG000|Outcome|Linagliptin|"Subjects given Linagliptin~Linagliptin~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
11165591|NCT01969084|OG001|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
11165592|NCT01969084|OG000|Outcome|Linagliptin|Linagliptin treated group
11165593|NCT01969084|OG001|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity"
11165594|NCT01969084|OG000|Outcome|Linagliptin|Subjects given Linagliptin
11165595|NCT01969084|OG001|Outcome|Sugar Pill|Subjects given sugar pill/placebo
11165596|NCT01969084|EG000|Reported Event|Linagliptin|Subjects given Linagliptin
11165597|NCT01969084|EG001|Reported Event|Sugar Pill|"Subjects given sugar pill/placebo~Placebo"
11165598|NCT01969162|BG000|Baseline|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
11165599|NCT01969162|FG000|Participant Flow|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
11165600|NCT01969162|OG000|Outcome|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
11165601|NCT01969162|EG000|Reported Event|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
11165602|NCT01969201|BG000|Baseline|Fostimon®|"75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)~Urofollitrophin"
11165603|NCT01969201|BG001|Baseline|Gonal-F®|"75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)~Follitrophin alpha"
11165604|NCT01969201|BG002|Baseline|Total|Total of all reporting groups
11165605|NCT01969201|FG000|Participant Flow|Fostimon®|"75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)~Urofollitrophin"
11165606|NCT01969201|FG001|Participant Flow|Gonal-F®|"75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)~Follitrophin alpha"
11165607|NCT01969201|OG000|Outcome|Fostimon®|"75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)~Urofollitrophin"
11165608|NCT01969201|OG001|Outcome|Gonal-F®|"75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)~Follitrophin alpha"
11165609|NCT01969201|EG000|Reported Event|Fostimon®|"75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)~Urofollitrophin"
11165610|NCT01969201|EG001|Reported Event|Gonal-F®|"75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)~Follitrophin alpha"
11165611|NCT01969214|BG000|Baseline|IQP-MM-101|"Dissolve the effervescent tablets in half a glass of water,to be taken orally~1 tablet, 3 times a day~IQP-MM-101: Dissolve the effervescent tablets in half a glass of water, to be taken orally~1 tablet, 3 times a day"
11165612|NCT01969214|FG000|Participant Flow|IQP-MM-101|"Dissolve the effervescent tablets in half a glass of water,to be taken orally~1 tablet, 3 times a day~IQP-MM-101: Dissolve the effervescent tablets in half a glass of water, to be taken orally~1 tablet, 3 times a day"
11165613|NCT01969214|OG000|Outcome|IQP-MM-101|"Dissolve the effervescent tablets in half a glass of water,to be taken orally~1 tablet, 3 times a day~IQP-MM-101: Dissolve the effervescent tablets in half a glass of water, to be taken orally~1 tablet, 3 times a day"
11165614|NCT01969214|EG000|Reported Event|IQP-MM-101|"Dissolve the effervescent tablets in half a glass of water,to be taken orally~1 tablet, 3 times a day~IQP-MM-101: Dissolve the effervescent tablets in half a glass of water, to be taken orally~1 tablet, 3 times a day"
11165615|NCT01969240|BG000|Baseline|Chest Pain Choice Decision Aid|"Patients randomized to the decision aid arm.~Chest Pain Choice Decision Aid: The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the ED visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort."
11165616|NCT01969240|BG001|Baseline|Usual Care|Patients randomized to the usual care arm (no decision aid used)
11165617|NCT01969240|BG002|Baseline|Total|Total of all reporting groups
11165618|NCT01969240|FG000|Participant Flow|Chest Pain Choice Decision Aid|"Patients randomized to the decision aid arm~Chest Pain Choice Decision Aid: The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the ED visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort."
11165619|NCT01969240|FG001|Participant Flow|Usual Care|Patients randomized to the usual care arm (no decision aid used)
11165620|NCT01969240|OG000|Outcome|Chest Pain Choice Decision Aid|"Patients randomized to the decision aid arm.~Chest Pain Choice Decision Aid: The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the ED visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort."
11165621|NCT01969240|OG001|Outcome|Usual Care|Patients randomized to the usual care arm (no decision aid used)
11165622|NCT01969240|OG000|Outcome|Chest Pain Choice Decision Aid|"Patients randomized to the decision aid arm~Chest Pain Choice Decision Aid: The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the ED visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort."
11165623|NCT01969240|OG000|Outcome|Chest Pain Choice Decision Aid|"Patients randomized to the decision aid arm.~Chest Pain Choice Decision Aid: The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort."
11228505|NCT02391311|FG001|Participant Flow|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
11228506|NCT02391311|OG000|Outcome|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
11228507|NCT02391311|OG001|Outcome|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
11228508|NCT02391311|EG000|Reported Event|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
11228509|NCT02391311|EG001|Reported Event|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
11228510|NCT02391337|BG000|Baseline|Beta-blocker|"In Group B, oral bisoprolol will be commenced at either 1.25mg, 2.5mg or 5mg according to the treatment schedule and uptitrated, as required, to 15mg daily. Recommended additional therapy in this arm includes diltiazem. Use of digoxin is explicitly discouraged but will not terminate participation in the study. If intolerance to bisoprolol occurs, investigators will be advised to try an alternate beta-blocker of their choosing (typically carvedilol, nebivolol, or metoprolol) at equivalent dosage.~Bisoprolol: Drug intervention"
11228511|NCT02391337|BG001|Baseline|Digoxin|"In Group A, the maintenance dose of oral digoxin will be either 62.5mcg or 125mcg according to the pre-defined treatment schedule and uptitrated, as required, to 250mcg daily. A single loading dose of four tablets (250 or 500mcg according to target maintenance dose) will be prescribed in digoxin-naïve participants, where necessary. Recommended additional therapy in this arm includes the calcium-channel blocker diltiazem. Use of beta-blockers is explicitly discouraged but will not terminate participation in the study.~Digoxin: Drug intervention"
11228512|NCT02391337|BG002|Baseline|Total|Total of all reporting groups
11228513|NCT02391337|FG000|Participant Flow|Beta-blocker|"In Group B, oral bisoprolol will be commenced at either 1.25mg, 2.5mg or 5mg according to the treatment schedule and uptitrated, as required, to 15mg daily. Recommended additional therapy in this arm includes diltiazem. Use of digoxin is explicitly discouraged but will not terminate participation in the study. If intolerance to bisoprolol occurs, investigators will be advised to try an alternate beta-blocker of their choosing (typically carvedilol, nebivolol, or metoprolol) at equivalent dosage.~Bisoprolol: Drug intervention"
11228514|NCT02391337|FG001|Participant Flow|Digoxin|"In Group A, the maintenance dose of oral digoxin will be either 62.5mcg or 125mcg according to the pre-defined treatment schedule and uptitrated, as required, to 250mcg daily. A single loading dose of four tablets (250 or 500mcg according to target maintenance dose) will be prescribed in digoxin-naïve participants, where necessary. Recommended additional therapy in this arm includes the calcium-channel blocker diltiazem. Use of beta-blockers is explicitly discouraged but will not terminate participation in the study.~Digoxin: Drug intervention"
11228515|NCT02391337|OG000|Outcome|Beta-blocker|"In Group B, oral bisoprolol will be commenced at either 1.25mg, 2.5mg or 5mg according to the treatment schedule and uptitrated, as required, to 15mg daily. Recommended additional therapy in this arm includes diltiazem. Use of digoxin is explicitly discouraged but will not terminate participation in the study. If intolerance to bisoprolol occurs, investigators will be advised to try an alternate beta-blocker of their choosing (typically carvedilol, nebivolol, or metoprolol) at equivalent dosage.~Bisoprolol: Drug intervention"
11228516|NCT02391337|OG001|Outcome|Digoxin|"In Group A, the maintenance dose of oral digoxin will be either 62.5mcg or 125mcg according to the pre-defined treatment schedule and uptitrated, as required, to 250mcg daily. A single loading dose of four tablets (250 or 500mcg according to target maintenance dose) will be prescribed in digoxin-naïve participants, where necessary. Recommended additional therapy in this arm includes the calcium-channel blocker diltiazem. Use of beta-blockers is explicitly discouraged but will not terminate participation in the study.~Digoxin: Drug intervention"
11228517|NCT02391337|EG000|Reported Event|Beta-blocker|"In Group B, oral bisoprolol will be commenced at either 1.25mg, 2.5mg or 5mg according to the treatment schedule and uptitrated, as required, to 15mg daily. Recommended additional therapy in this arm includes diltiazem. Use of digoxin is explicitly discouraged but will not terminate participation in the study. If intolerance to bisoprolol occurs, investigators will be advised to try an alternate beta-blocker of their choosing (typically carvedilol, nebivolol, or metoprolol) at equivalent dosage.~Bisoprolol: Drug intervention"
11228518|NCT02391337|EG001|Reported Event|Digoxin|"In Group A, the maintenance dose of oral digoxin will be either 62.5mcg or 125mcg according to the pre-defined treatment schedule and uptitrated, as required, to 250mcg daily. A single loading dose of four tablets (250 or 500mcg according to target maintenance dose) will be prescribed in digoxin-naïve participants, where necessary. Recommended additional therapy in this arm includes the calcium-channel blocker diltiazem. Use of beta-blockers is explicitly discouraged but will not terminate participation in the study.~Digoxin: Drug intervention"
11228519|NCT02391350|BG000|Baseline|Usual Care|"Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.~Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active."
11228520|NCT02391350|BG001|Baseline|Early Intervention|"Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.~Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.~Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms."
11228521|NCT02391350|BG002|Baseline|Total|Total of all reporting groups
11228522|NCT02391350|FG000|Participant Flow|Usual Care|"Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.~Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active."
11228523|NCT02391350|FG001|Participant Flow|Early Intervention|"Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.~Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.~Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms."
11228524|NCT02391350|OG000|Outcome|Usual Care|"Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.~Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active."
11233900|NCT02431468|OG000|Outcome|Bryostatin 1 20ug With Memantine|"Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11342299|NCT03704376|OG001|Outcome|Adductor Canal Blockade|"Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).~15 ml of 0.2% ropivacaine~100 mcg clonidine~High-frequency linear ultrasound transducer"
11349223|NCT04109703|OG000|Outcome|High Level Pulsed Heat|"Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.~Generation 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection."
11349224|NCT04109703|OG001|Outcome|Low Level Steady Heat|"Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.~Generation 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection."
11349225|NCT04109703|OG000|Outcome|High Level Pulsed Heat|Subjects who received the high level pulsed heat device with heat pulses up to 45 degrees C.
11349226|NCT04109703|OG001|Outcome|Steady Heat Group|Subjects who received the steady heat device with heat received a steady level of heat at 37 degrees C.
11349227|NCT04109703|EG000|Reported Event|High Level Pulsed Heat|Subjects in this group received the active (experimental) device that utilized high level pulsed heat to a temperature of 45 degrees C.
11349228|NCT04109703|EG001|Reported Event|Low Level Steady Heat Group|Subjects in this group received the control device that utilized steady heat at a temperature of 37 degrees C.
11165624|NCT01969240|EG000|Reported Event|Chest Pain Choice Decision Aid|"Patients randomized to the decision aid arm.~Chest Pain Choice Decision Aid: The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the ED visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort."
11165625|NCT01969240|EG001|Reported Event|Usual Care|Patients randomized to the usual care arm (no decision aid used)
11165626|NCT01969435|BG000|Baseline|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
11165627|NCT01969435|FG000|Participant Flow|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
11165628|NCT01969435|OG000|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
11349229|NCT04109443|BG000|Baseline|Young Men & Media Program Group|"Participants randomized to the Young Men and Media Program group will have access to the online sexual health media literacy materials. They will also complete three assessments at baseline, post-intervention, and a 3 month follow-up.~Young Men & Media Program: The online sexual health media literacy website includes content about (1) male anatomy; (2) HIV/STI prevention; (3) overall sexual health; and (4) sexually explicit online media (SEOM) literacy."
11349230|NCT04109443|BG001|Baseline|Control Group|"Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.~Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV."
11349231|NCT04109443|BG002|Baseline|Total|Total of all reporting groups
11349232|NCT04109443|FG000|Participant Flow|Young Men & Media Program Group|"Participants randomized to the Young Men and Media Program group will have access to the online sexual health media literacy materials. They will also complete three assessments at baseline, post-intervention, and a 3 month follow-up.~Young Men & Media Program: The online sexual health media literacy website includes content about (1) male anatomy; (2) HIV/STI prevention; (3) overall sexual health; and (4) sexually explicit online media (SEOM) literacy."
11349233|NCT04109443|FG001|Participant Flow|Control Group|"Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.~Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV."
11349234|NCT04109443|OG000|Outcome|All Eligible Participants|Based on responses to the online screener survey, 422 potential participants were identified.
11349235|NCT04109443|OG000|Outcome|Participants Who Clicked the Banner|Total number of clicks on the banner ads.
11349236|NCT04109443|OG000|Outcome|Young Men & Media Program Group|"Participants randomized to the Young Men and Media Program group will have access to the online sexual health media literacy materials. They will also complete three assessments at baseline, post-intervention, and a 3 month follow-up.~Young Men & Media Program: The online sexual health media literacy website includes content about (1) male anatomy; (2) HIV/STI prevention; (3) overall sexual health; and (4) sexually explicit online media (SEOM) literacy."
11165629|NCT01969435|EG000|Reported Event|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
11165630|NCT01969448|BG000|Baseline|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165631|NCT01969448|BG001|Baseline|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165632|NCT01969448|BG002|Baseline|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165633|NCT01969448|BG003|Baseline|Total|Total of all reporting groups
11165634|NCT01969448|FG000|Participant Flow|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165635|NCT01969448|FG001|Participant Flow|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165636|NCT01969448|FG002|Participant Flow|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165637|NCT01969448|OG000|Outcome|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165638|NCT01969448|OG001|Outcome|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11174035|NCT02019472|OG001|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
11349237|NCT04109443|OG001|Outcome|Control Group|"Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.~Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV."
11349238|NCT04109443|OG000|Outcome|All Participants in the Study|All 154 participants combined from the Young Men & Media group (N=77) and the control group (N=77).
11349239|NCT04109443|EG000|Reported Event|Young Men & Media Program Group|"Participants randomized to the Young Men and Media Program group will have access to the online sexual health media literacy materials. They will also complete three assessments at baseline, post-intervention, and a 3 month follow-up.~Young Men & Media Program: The online sexual health media literacy website includes content about (1) male anatomy; (2) HIV/STI prevention; (3) overall sexual health; and (4) sexually explicit online media (SEOM) literacy."
11349240|NCT04109443|EG001|Reported Event|Control Group|"Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.~Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV."
11349241|NCT04107493|BG000|Baseline|All Study Participants|Participants acted as their own control during this study. Participants used a portable oxygen cylinder whilst doing a 6 minute walking test. After a wash out period the participants completed the 6 minute walking test with the second portable oxygen cylinder. The order of the oxygen cylinders (mobi or standard) was randomised
11349242|NCT04107493|FG000|Participant Flow|Portable Oxygen Cylinder, Then Mobi|"Participants acted as their own control in this study.~Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC~Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients"
11349243|NCT04107493|FG001|Participant Flow|Mobi, Then Portable Oxygen Cylinder|"Participants acted as their own control in this study.~Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC~Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients"
11349244|NCT04107493|OG000|Outcome|Portable Oxygen Cylinder|"Continuous flow oxygen cylinders will be used as a comparison.~Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients"
11349245|NCT04107493|OG001|Outcome|Mobi™ Portable Oxygen Concentrator|"Mobi™ is indicated for patients who require supplemental oxygen, including COPD patients. It provides supplemental, high oxygen concentration to these patients. It is available via prescription only and may be used in the home, institution, and hospital settings, as well as travel environments~Mobi: ResMed's variant of POC"
11349246|NCT04107493|EG000|Reported Event|Standard Oxygen Cylinder|"Participants acted as their own control in this study.~Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC~Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients"
11349247|NCT04107493|EG001|Reported Event|Mobi|"Participants acted as their own control in this study.~Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC~Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients"
11349248|NCT04106817|BG000|Baseline|Cohort 1|"1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349249|NCT04106817|BG001|Baseline|Cohort 2|"1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349250|NCT04106817|BG002|Baseline|Cohort 3|"1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349251|NCT04106817|BG003|Baseline|Total|Total of all reporting groups
11349252|NCT04106817|FG000|Participant Flow|Cohort 1|"1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349253|NCT04106817|FG001|Participant Flow|Cohort 2|"1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349254|NCT04106817|FG002|Participant Flow|Cohort 3|"1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349255|NCT04106817|OG000|Outcome|Cohort 1|"1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349256|NCT04106817|OG001|Outcome|Cohort 2|"1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349257|NCT04106817|OG002|Outcome|Cohort 3|"1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349258|NCT04106817|EG000|Reported Event|Cohort 1|"1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349259|NCT04106817|EG001|Reported Event|Cohort 2|"1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349260|NCT04106817|EG002|Reported Event|Cohort 3|"1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)~Live, wild-type A/California/H1N1 2009 influenza virus"
11349261|NCT04105972|BG000|Baseline|TEZ/IVA|Following TEZ/IVA run-in period of 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11349262|NCT04105972|BG001|Baseline|ELX/TEZ/IVA|Following TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11349263|NCT04105972|BG002|Baseline|Total|Total of all reporting groups
11349264|NCT04105972|FG000|Participant Flow|TEZ/IVA|Following TEZ (tezacaftor)/IVA (ivacaftor) run-in period of 4 weeks, participants received TEZ 100 milligrams (mg) once daily (qd)/IVA 150 mg every 12 hours (q12h) in the treatment period for 24 weeks.
11349265|NCT04105972|FG001|Participant Flow|ELX/TEZ/IVA|Following TEZ/IVA run-in period of 4 weeks, participants received ELX (elexacaftor) 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11349266|NCT04105972|OG000|Outcome|TEZ/IVA|Following TEZ/IVA run-in period of 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11349267|NCT04105972|OG001|Outcome|ELX/TEZ/IVA|Following TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11349268|NCT04105972|EG000|Reported Event|TEZ/IVA|Following TEZ/IVA run-in period of 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11165639|NCT01969448|OG002|Outcome|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11349269|NCT04105972|EG001|Reported Event|ELX/TEZ/IVA|Following TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11349270|NCT04105218|BG000|Baseline|Evening Exercise Condition --> Control Condition|"Participants will arrive in the Clinical and Translation Research Center (CTRC) and enter the whole room calorimeter approximately 1 hour after arrival. Participants will perform 45-min of moderate intensity continuous exercise on a treadmill 12 hours after habitual wake time in the evening. Participants will begin with a warm-up for 5 minutes at 2.0-2.5 mph. Heart rate will be monitored continuously with a heart rate monitor. Participants will maintain heart rate at 65% of age-predicted maximum heart rate. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva~Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control"
11349271|NCT04105218|BG001|Baseline|Control Condition --> Evening Exercise Condition|"Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva~Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle."
11349272|NCT04105218|BG002|Baseline|Total|Total of all reporting groups
11349273|NCT04105218|FG000|Participant Flow|Evening Exercise Condition --> Control Condition|"Participants will arrive in the Clinical and Translation Research Center (CTRC) and enter the whole room calorimeter approximately 1 hour after arrival. Participants will perform 45-min of moderate intensity continuous exercise on a treadmill 12 hours after habitual wake time in the evening. Participants will begin with a warm-up for 5 minutes at 2.0-2.5 mph. Heart rate will be monitored continuously with a heart rate monitor. Participants will maintain heart rate at 65% of age-predicted maximum heart rate. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva~Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control"
11165640|NCT01969448|EG000|Reported Event|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165641|NCT01969448|EG001|Reported Event|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165642|NCT01969448|EG002|Reported Event|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
11165643|NCT01969500|BG000|Baseline|Treatment as Usual|"Treatment as usual includes outpatient case management, linkage to services and medication monitoring.~Treatment as Usual"
11165644|NCT01969500|BG001|Baseline|Mobile Application|"Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.~Mobile Application"
11165645|NCT01969500|BG002|Baseline|Total|Total of all reporting groups
11165646|NCT01969500|FG000|Participant Flow|Treatment as Usual|"Treatment as usual includes outpatient case management, linkage to services and medication monitoring.~Treatment as Usual"
11165647|NCT01969500|FG001|Participant Flow|Mobile Application|"Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.~Mobile Application"
11165648|NCT01969500|OG000|Outcome|Treatment as Usual|"Treatment as usual includes outpatient case management, linkage to services and medication monitoring.~Treatment as Usual"
11165649|NCT01969500|OG001|Outcome|Mobile Application|"Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.~Mobile Application"
11165650|NCT01969500|EG000|Reported Event|Treatment as Usual|"Treatment as usual includes outpatient case management, linkage to services and medication monitoring.~Treatment as Usual"
11165651|NCT01969500|EG001|Reported Event|Mobile Application|"Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.~Mobile Application"
11165652|NCT01969539|BG000|Baseline|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
11165653|NCT01969539|FG000|Participant Flow|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
11165654|NCT01969539|OG000|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
11165655|NCT01969539|EG000|Reported Event|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
11165656|NCT01969708|BG000|Baseline|Aflibercept|"2.0 mg aflibercept every 4 weeks~aflibercept"
11165657|NCT01969708|BG001|Baseline|Bevacizumab|"1.25 mg bevacizumab every 4 weeks~bevacizumab"
11165658|NCT01969708|BG002|Baseline|Total|Total of all reporting groups
11165659|NCT01969708|FG000|Participant Flow|Aflibercept|"2.0 mg aflibercept every 4 weeks~aflibercept"
11165660|NCT01969708|FG001|Participant Flow|Bevacizumab|"1.25 mg bevacizumab every 4 weeks~bevacizumab"
11165661|NCT01969708|OG000|Outcome|Aflibercept|"2.0 mg aflibercept every 4 weeks~aflibercept"
11165662|NCT01969708|OG001|Outcome|Bevacizumab|"1.25 mg bevacizumab every 4 weeks~bevacizumab"
11165663|NCT01969708|EG000|Reported Event|Aflibercept|"2.0 mg aflibercept every 4 weeks~aflibercept"
11165664|NCT01969708|EG001|Reported Event|Bevacizumab|"1.25 mg bevacizumab every 4 weeks~bevacizumab"
11174036|NCT02019472|OG002|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
11174037|NCT02019472|EG000|Reported Event|Adalimumab 40 mg q2w Only|Participants received 40 mg of adalimumab subcutaneously q2w for 52 weeks.
11174038|NCT02019472|EG001|Reported Event|Adalimumab 40 mg q2w Then 40 mg q1w|Participants received 40 mg adalimumab subcutaneously q2w until Week 16 and received 40 mg adalimumab subcutaneously weekly (q1w) (due to EE) through Week 52.
11228525|NCT02391350|OG001|Outcome|Early Intervention|"Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.~Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.~Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms."
11228526|NCT02391350|EG000|Reported Event|Usual Care|"Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.~Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active."
11228527|NCT02391350|EG001|Reported Event|Early Intervention|"Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.~Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.~Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms."
11228528|NCT02391363|BG000|Baseline|Calmer Life|"Cognitive behavior treatment for anxiety~Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices"
11228529|NCT02391363|BG001|Baseline|Enhanced Community Care|"Enhanced information and referral services for mental health and basic needs~Information and referral: Resource counseling and follow-up for mental health and basic needs"
11228530|NCT02391363|BG002|Baseline|Total|Total of all reporting groups
11228531|NCT02391363|FG000|Participant Flow|Calmer Life|"Cognitive behavior treatment for anxiety~Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices"
11228532|NCT02391363|FG001|Participant Flow|Enhanced Community Care|"Enhanced information and referral services for mental health and basic needs~Information and referral: Resource counseling and follow-up for mental health and basic needs"
11228533|NCT02391363|OG000|Outcome|Calmer Life|"Cognitive behavior treatment for anxiety~Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices"
11228534|NCT02391363|OG001|Outcome|Enhanced Community Care|"Enhanced information and referral services for mental health and basic needs~Information and referral: Resource counseling and follow-up for mental health and basic needs"
11228535|NCT02391363|EG000|Reported Event|Calmer Life|"Cognitive behavior treatment for anxiety~Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices"
11228536|NCT02391363|EG001|Reported Event|Enhanced Community Care|"Enhanced information and referral services for mental health and basic needs~Information and referral: Resource counseling and follow-up for mental health and basic needs"
11228537|NCT02391545|BG000|Baseline|Duvelisib and Obinutuzumab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.~Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~IPI-145 (duvelisib): PI3K Inhibitor~Obinutuzumab"
11228538|NCT02391545|BG001|Baseline|Duvelisib and Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.~Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~IPI-145 (duvelisib): PI3K Inhibitor~Rituximab"
11228539|NCT02391545|BG002|Baseline|Total|Total of all reporting groups
11228540|NCT02391545|FG000|Participant Flow|Duvelisib and Obinutuzumab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.~Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~IPI-145 (duvelisib): PI3K Inhibitor~Obinutuzumab"
11228541|NCT02391545|FG001|Participant Flow|Duvelisib and Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.~Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~IPI-145 (duvelisib): PI3K Inhibitor~Rituximab"
11228542|NCT02391545|OG000|Outcome|Duvelisib and Obinutuzumab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.~Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~Duvelisib: PI3K Inhibitor~Obinutuzumab"
11228543|NCT02391545|OG001|Outcome|Duvelisib and Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles.~Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~Duvelisib: PI3K Inhibitor~Rituximab"
11228544|NCT02391545|OG001|Outcome|Duvelisib and Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.~Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~Duvelisib: PI3K Inhibitor~Rituximab"
11228545|NCT02391545|EG000|Reported Event|Duvelisib and Obinutuzumab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.~Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~IPI-145 (duvelisib): PI3K Inhibitor~Obinutuzumab"
11228546|NCT02391545|EG001|Reported Event|Duvelisib and Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.~Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.~IPI-145 (duvelisib): PI3K Inhibitor~Rituximab"
11228547|NCT02391584|BG000|Baseline|XprESS|"Balloon dilation of the Eustachian tube~XprESS: Balloon dilation of the Eustachian tube"
11228548|NCT02391584|BG001|Baseline|Control|"Continued medical management~Control: Continued medical management"
11228549|NCT02391584|BG002|Baseline|Total|Total of all reporting groups
11228550|NCT02391584|FG000|Participant Flow|XprESS|"Balloon dilation of the Eustachian tube~XprESS: Balloon dilation of the Eustachian tube"
11228551|NCT02391584|FG001|Participant Flow|Control|"Continued medical management~Control: Continued medical management"
11228552|NCT02391584|OG000|Outcome|XprESS|"Balloon dilation of the Eustachian tube~XprESS: Balloon dilation of the Eustachian tube"
11228553|NCT02391584|OG001|Outcome|Control|"Continued medical management~Control: Continued medical management"
11228554|NCT02391584|OG000|Outcome|All Balloon Dilation Attempts|All Eustachian tubes that underwent an attempted balloon dilation in participants who were randomized to balloon dilation or control participants who crossed over to balloon dilation.
11228555|NCT02391584|OG000|Outcome|All Balloon Dilation Participants|Participants randomized and treated with balloon dilation and control participants who crossed over to balloon dilation.
11228556|NCT02391584|EG000|Reported Event|XprESS Randomized Arm at 6 Weeks|All participants randomized to balloon dilation and followed through at least the 6-week visit. One randomized balloon dilation participant did not undergo procedure and did not return for the 6-week visit, so this participant is not included in the safety analysis. One other participant did not complete the ETDQ-7 for the primary efficacy endpoint but otherwise completed the rest of the 6-week visit and is therefore included in the safety analysis, resulting in a total XprESS safety population of 30.
11228557|NCT02391584|EG001|Reported Event|Control Randomized Arm at 6 Weeks|All participants randomized to control and followed through at least the 6-week visit. Two randomized control participants did not return for the 6-week visit, so are not included in the safety analysis resulting in a total control population of 27 for the safety analysis. Control participants who did not crossover were exited from the study after the 6-week visit.
11228558|NCT02391584|EG002|Reported Event|All Participants Through 12 Months|All participants who were followed through at least the 6-week visit. After the 6-week visit, control participants were either exited or crossed over the balloon dilation.
11228559|NCT02391701|BG000|Baseline|Diet Group|"Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine.~Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)"
11228560|NCT02391701|BG001|Baseline|Control|No intervention
11228561|NCT02391701|BG002|Baseline|Total|Total of all reporting groups
11228562|NCT02391701|FG000|Participant Flow|Diet Group|"Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine.~Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)"
11228563|NCT02391701|FG001|Participant Flow|Control|No intervention
11228564|NCT02391701|OG000|Outcome|Diet Group|"Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine.~Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)"
11228565|NCT02391701|OG001|Outcome|Control|No intervention
11165665|NCT01969721|BG000|Baseline|Overall Study|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
11165666|NCT01969721|FG000|Participant Flow|T+O 2.5/5 / T+O 5/5 / F+S 250/50 / F+S 500/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled .~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 2.5/5).~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 5/5).~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 250/50).~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 500/50).~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
11165667|NCT01969721|FG001|Participant Flow|T+O 5/5 / F+S 500/50 / T+O 2.5/5 / F+S 250/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
11165668|NCT01969721|FG002|Participant Flow|F+S 250/50 / T+O 2.5/5 / F+S 500/50 / T+O 5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
11165669|NCT01969721|FG003|Participant Flow|F+S 500/50 / F+S 250/50 / T+O 5/5 / T+O 2.5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
11165670|NCT01969721|OG000|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
11165671|NCT01969721|OG001|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
11165672|NCT01969721|OG002|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
11165673|NCT01969721|OG003|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
11165674|NCT01969721|EG000|Reported Event|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
11165675|NCT01969721|EG001|Reported Event|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
11165676|NCT01969721|EG002|Reported Event|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
11165677|NCT01969721|EG003|Reported Event|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
11165678|NCT01969747|BG000|Baseline|Placebo|Placebo tablet; oral administration once daily
11165679|NCT01969747|BG001|Baseline|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
11165680|NCT01969747|BG002|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
11165681|NCT01969747|BG003|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
11165682|NCT01969747|BG004|Baseline|Total|Total of all reporting groups
11165683|NCT01969747|FG000|Participant Flow|Placebo|Placebo tablet; oral administration once daily
11165684|NCT01969747|FG001|Participant Flow|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
11165685|NCT01969747|FG002|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
11165686|NCT01969747|FG003|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
11165687|NCT01969747|OG000|Outcome|Placebo|Placebo tablet; oral administration once daily
11165688|NCT01969747|OG001|Outcome|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
11165689|NCT01969747|OG002|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
11165690|NCT01969747|OG003|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
11165691|NCT01969747|EG000|Reported Event|Placebo|Placebo tablet; oral administration once daily
11165692|NCT01969747|EG001|Reported Event|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
11165693|NCT01969747|EG002|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
11165694|NCT01969747|EG003|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
11165695|NCT01969799|BG000|Baseline|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
11165696|NCT01969799|BG001|Baseline|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
11165697|NCT01969799|BG002|Baseline|Total|Total of all reporting groups
11165698|NCT01969799|FG000|Participant Flow|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
11165699|NCT01969799|FG001|Participant Flow|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
11165700|NCT01969799|OG000|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
11165701|NCT01969799|OG001|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
11165702|NCT01969799|EG000|Reported Event|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
11165703|NCT01969799|EG001|Reported Event|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
11165704|NCT01969851|BG000|Baseline|Lacosamide 1 Month - <4 Years|Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165705|NCT01969851|BG001|Baseline|Lacosamide 4 Years - <12 Years|Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
10887776|NCT00502671|EG000|Reported Event|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
10887777|NCT00502697|BG000|Baseline|Treatment Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
10887778|NCT00502697|BG001|Baseline|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
11089338|NCT01523457|BG000|Baseline|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
11228566|NCT02391701|EG000|Reported Event|Diet Group|"Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine.~Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)"
11228567|NCT02391701|EG001|Reported Event|Control|No intervention
11228568|NCT02391714|BG000|Baseline|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
10887779|NCT00502697|BG002|Baseline|Total|Total of all reporting groups
11089339|NCT01523457|BG001|Baseline|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
11089340|NCT01523457|BG002|Baseline|Total|Total of all reporting groups
11228569|NCT02391714|BG001|Baseline|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
11228570|NCT02391714|BG002|Baseline|Total|Total of all reporting groups
11228571|NCT02391714|FG000|Participant Flow|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
11233901|NCT02431468|OG001|Outcome|Bryostatin 1 40ug With Memantine|"Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11233902|NCT02431468|OG002|Outcome|Placebo With Memantine|"Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution."
11174039|NCT02019472|EG002|Reported Event|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
11233903|NCT02431468|OG003|Outcome|Bryostatin 1 20ug Without Memantine|Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
11174040|NCT02019472|EG003|Reported Event|Sirukumab 50 mg q4w Only|Participants received 50 mg of sirukumab subcutaneously every four weeks (q4w) for 52 weeks.
11174041|NCT02019472|EG004|Reported Event|Sirukumab 50 mg q4w Then 100 mg q2w|Participants received 50 mg sirukumab until Week 16 and received 100 mg sirukumab subcutaneously q4w (due to EE or inadvertently) through Week 52.
11174042|NCT02019472|EG005|Reported Event|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
11174043|NCT02019472|EG006|Reported Event|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
11174044|NCT02019550|BG000|Baseline|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
11174045|NCT02019550|BG001|Baseline|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
11174046|NCT02019550|BG002|Baseline|Total|Total of all reporting groups
11174047|NCT02019550|FG000|Participant Flow|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
11174048|NCT02019550|FG001|Participant Flow|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
11174049|NCT02019550|OG000|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
11174050|NCT02019550|OG001|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
11174051|NCT02019550|OG000|Outcome|Rebif Rebidose|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
11174052|NCT02019550|OG001|Outcome|Rebiject II|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
11174053|NCT02019550|EG000|Reported Event|Rebif Rebidose|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
11174054|NCT02019550|EG001|Reported Event|Rebiject II|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
11174055|NCT02019563|BG000|Baseline|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
11174056|NCT02019563|BG001|Baseline|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
11174057|NCT02019563|BG002|Baseline|Total|Total of all reporting groups
11174058|NCT02019563|FG000|Participant Flow|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
11174059|NCT02019563|FG001|Participant Flow|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
11228572|NCT02391714|FG001|Participant Flow|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
11228573|NCT02391714|OG000|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
11228574|NCT02391714|OG001|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
11228575|NCT02391714|OG000|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
11228576|NCT02391714|OG001|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients"
11228577|NCT02391714|EG000|Reported Event|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
11228578|NCT02391714|EG001|Reported Event|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
11228579|NCT02391948|BG000|Baseline|Gross Motor Function Classification System (GMFCS) Level I|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
11228580|NCT02391948|BG001|Baseline|Gross Motor Function Classification System (GMFCS) Level II|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
11228581|NCT02391948|BG002|Baseline|Gross Motor Function Classification System (GMFCS) Level III|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
11228582|NCT02391948|BG003|Baseline|Gross Motor Function Classification System (GMFCS) Level IV|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
11228583|NCT02391948|BG004|Baseline|Gross Motor Function Classification System (GMFCS) Level V|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
11228584|NCT02391948|BG005|Baseline|Total|Total of all reporting groups
11228585|NCT02391948|FG000|Participant Flow|Gross Motor Function Classification System (GMFCS) Level I|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
11228586|NCT02391948|FG001|Participant Flow|Gross Motor Function Classification System (GMFCS) Level II|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
11228587|NCT02391948|FG002|Participant Flow|Gross Motor Function Classification System (GMFCS) Level III|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
11228588|NCT02391948|FG003|Participant Flow|Gross Motor Function Classification System (GMFCS) Level IV|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
11228589|NCT02391948|FG004|Participant Flow|Gross Motor Function Classification System (GMFCS) Level V|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
11228590|NCT02391948|OG000|Outcome|Gross Motor Function Classification System (GMFCS) Level I|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
11228591|NCT02391948|OG001|Outcome|Gross Motor Function Classification System (GMFCS) Level II|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
11228592|NCT02391948|OG002|Outcome|Gross Motor Function Classification System (GMFCS) Level III|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
11228593|NCT02391948|OG003|Outcome|Gross Motor Function Classification System (GMFCS) Level IV|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
11228594|NCT02391948|OG004|Outcome|Gross Motor Function Classification System (GMFCS) Level V|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
11228595|NCT02391948|OG001|Outcome|Gross Motor Function Classification System (GMFCS) Level II|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
11228596|NCT02391948|OG002|Outcome|Gross Motor Function Classification System (GMFCS) Level III|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
11228597|NCT02391948|OG000|Outcome|Gross Motor Function Classification System (GMFCS) Level I|Participants scored on the GMFCS
11233904|NCT02431468|OG004|Outcome|Bryostatin 1 40ug Without Memantine|Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
11349274|NCT04105218|FG001|Participant Flow|Control Condition --> Evening Exercise Condition|"Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva~Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle."
11349275|NCT04105218|OG000|Outcome|Evening Exercise|"Participants will arrive in the Clinical and Translation Research Center (CTRC) and enter the whole room calorimeter approximately 1 hour after arrival. Participants will perform 45-min of moderate intensity continuous exercise on a treadmill 12 hours after habitual wake time in the evening. Participants will begin with a warm-up for 5 minutes at 2.0-2.5 mph. Heart rate will be monitored continuously with a heart rate monitor. Participants will maintain heart rate at 65% of age-predicted maximum heart rate. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva~Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control"
11349276|NCT04105218|OG001|Outcome|Control|"Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva~Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle."
11349277|NCT04105218|EG000|Reported Event|Evening Exercise|"Participants will arrive in the Clinical and Translation Research Center (CTRC) and enter the whole room calorimeter approximately 1 hour after arrival. Participants will perform 45-min of moderate intensity continuous exercise on a treadmill 12 hours after habitual wake time in the evening. Participants will begin with a warm-up for 5 minutes at 2.0-2.5 mph. Heart rate will be monitored continuously with a heart rate monitor. Participants will maintain heart rate at 65% of age-predicted maximum heart rate. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva~Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control"
11357184|NCT03763175|OG001|Outcome|SYN-010 42 mg|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (42 mg PO QD). Study activities will be the same across all three arms.~SYN-010 42 mg: 42 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11165706|NCT01969851|BG002|Baseline|Lacosamide 12 Years - <18 Years|Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165707|NCT01969851|BG003|Baseline|Total Title|
11349278|NCT04105218|EG001|Reported Event|Control|"Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva~Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle."
11349279|NCT04102956|BG000|Baseline|Kallikrein+Standard Treatment Group|The Kallikrein+Standard treatment group was given kallikrein through intravenous injection to treatment for 0.15 PNA/day+standard treatment medicine based on the guidelines for the treatment of acute ischemic stroke for 14 ± 5 days.
11349280|NCT04102956|BG001|Baseline|Standard Treatment Group|The Standard treatment group was only given standard treatment medicine based on the guidelines for the treatment of acute ischemic stroke for 14 ± 5 days.
11349281|NCT04102956|BG002|Baseline|Total|Total of all reporting groups
11349282|NCT04102956|FG000|Participant Flow|Kallikrein+Standard Treatment Group|The Kallikrein+Standard treatment group was given kallikrein through intravenous injection to treatment for 0.15 PNA/day+standard treatment medicine based on the guidelines for the treatment of acute ischemic stroke for 14 ± 5 days.
11349283|NCT04102956|FG001|Participant Flow|Standard Treatment Group|The Standard treatment group was only given standard treatment medicine based on the guidelines for the treatment of acute ischemic stroke for 14 ± 5 days.
11349284|NCT04102956|OG000|Outcome|Kallikrein+Standard Treatment Group|The Kallikrein+Standard treatment group was given kallikrein through intravenous injection to treatment for 0.15 PNA/day+standard treatment medicine based on the guidelines for the treatment of acute ischemic stroke for 14 ± 5 days.
11349285|NCT04102956|OG001|Outcome|Standard Treatment Group|The Standard treatment group was only given standard treatment medicine based on the guidelines for the treatment of acute ischemic stroke for 14 ± 5 days.
11349286|NCT04102956|EG000|Reported Event|Kallikrein+Standard Treatment Group|The Kallikrein+Standard treatment group was given kallikrein through intravenous injection to treatment for 0.15 PNA/day+standard treatment medicine based on the guidelines for the treatment of acute ischemic stroke for 14 ± 5 days.
11349287|NCT04102956|EG001|Reported Event|Standard Treatment Group|The Standard treatment group was only given standard treatment medicine based on the guidelines for the treatment of acute ischemic stroke for 14 ± 5 days.
11349288|NCT04102540|BG000|Baseline|Intervention Group|"Participants in the intervention group will receive health education using infographics (Infographic Intervention) during a study visit scheduled immediately following their regularly scheduled clinic visits.~Infographic intervention: Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits."
11349289|NCT04102540|FG000|Participant Flow|Infographic Intervention Group|"Participants in the intervention group will receive health education using infographics (Infographic Intervention) during a study visit scheduled immediately following their regularly scheduled clinic visits.~Infographic intervention: Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits."
11349290|NCT04102540|OG000|Outcome|Infographic Intervention Group|"Participants in the intervention group will receive health education using infographics (Infographic Intervention) during a study visit scheduled immediately following their regularly scheduled clinic visits.~Infographic intervention: Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits."
11349291|NCT04102540|EG000|Reported Event|Intervention Group|"Participants in the intervention group will receive health education using infographics (Infographic Intervention) during a study visit scheduled immediately following their regularly scheduled clinic visits.~Infographic intervention: Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits."
11349292|NCT04102345|BG000|Baseline|Lavender|"1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser.~Lavender Aromatherapy: Commercially available lavender essential oil and diffuser."
11349293|NCT04102345|BG001|Baseline|Zolpidem|"Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible.~Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem."
11349294|NCT04102345|BG002|Baseline|Total|Total of all reporting groups
11349295|NCT04102345|FG000|Participant Flow|Lavender|"1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser.~Lavender Aromatherapy: Commercially available lavender essential oil and diffuser."
11349296|NCT04102345|FG001|Participant Flow|Zolpidem|"Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible.~Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem."
11349297|NCT04102345|OG000|Outcome|Lavender|"1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser.~Lavender Aromatherapy: Commercially available lavender essential oil and diffuser."
11349298|NCT04102345|OG001|Outcome|Zolpidem|"Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible.~Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem."
11349299|NCT04102345|EG000|Reported Event|Lavender|"1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser.~Lavender Aromatherapy: Commercially available lavender essential oil and diffuser."
11349300|NCT04102345|EG001|Reported Event|Zolpidem|"Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible.~Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem."
11349301|NCT04092907|BG000|Baseline|HBM9036 0.25% Ophthalmic Solution|"HBM9036, Ophthalmic Solution, twice a day, in the morning and evening~HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution"
11349302|NCT04092907|BG001|Baseline|Placebo Ophthalmic Solution|"placebo, Ophthalmic Solution, twice a day, in the morning and evening~placebo: Ophthalmic Solution"
11349303|NCT04092907|BG002|Baseline|Total|Total of all reporting groups
11349304|NCT04092907|FG000|Participant Flow|HBM9036 0.25% Ophthalmic Solution|HBM9036, Ophthalmic Solution, twice a day, in the morning and evening
11349305|NCT04092907|FG001|Participant Flow|Placebo Ophthalmic Solution|placebo, Ophthalmic Solution, twice a day, in the morning and evening
11349306|NCT04092907|OG000|Outcome|HBM9036 0.25% Ophthalmic Solution|"HBM9036, Ophthalmic Solution, twice a day, in the morning and evening~HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution"
11349307|NCT04092907|OG001|Outcome|Placebo Ophthalmic Solution|"placebo, Ophthalmic Solution, twice a day, in the morning and evening~placebo: Ophthalmic Solution"
11349308|NCT04092907|EG000|Reported Event|HBM9036 0.25% Ophthalmic Solution|"HBM9036, Ophthalmic Solution, twice a day, in the morning and evening~HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution"
11349309|NCT04092907|EG001|Reported Event|Placebo Ophthalmic Solution|"placebo, Ophthalmic Solution, twice a day, in the morning and evening~placebo: Ophthalmic Solution"
11349310|NCT04089982|BG000|Baseline|Varenicline|"Varenicline BID~Varenicline: Chantix"
11349311|NCT04089982|BG001|Baseline|Placebo|Placebo oral tablet: Placebo
11349312|NCT04089982|BG002|Baseline|Total|Total of all reporting groups
11349313|NCT04089982|FG000|Participant Flow|Varenicline|"Varenicline BID~Varenicline: Chantix"
11349314|NCT04089982|FG001|Participant Flow|Placebo|Placebo oral tablet: Placebo
11349315|NCT04089982|OG000|Outcome|Varenicline|"Varenicline BID~Varenicline: Chantix"
11349316|NCT04089982|OG001|Outcome|Placebo|Placebo oral tablet: Placebo
11349317|NCT04089982|EG000|Reported Event|Varenicline|"Varenicline BID~Varenicline: Chantix"
11349318|NCT04089982|EG001|Reported Event|Placebo|Placebo oral tablet: Placebo
11349319|NCT04086433|BG000|Baseline|Arm A - Echelon Stapler|"Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, Echelon) and evaluated for burst pressure and staple malformation~gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment"
11349320|NCT04086433|BG001|Baseline|Arm B - Titan Stapler|"Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, Titan) and evaluated for burst pressure and staple malformation~gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment"
11349321|NCT04086433|BG002|Baseline|Total|Total of all reporting groups
11349322|NCT04086433|FG000|Participant Flow|Arm A - Echelon Stapler|"Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, Echelon) and evaluated for burst pressure and staple malformation~gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment"
11349323|NCT04086433|FG001|Participant Flow|Arm B - Titan Stapler|"Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, Titan) and evaluated for burst pressure and staple malformation~gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment"
11349324|NCT04086433|OG000|Outcome|Arm A - Echelon Stapler|"Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, Echelon) and evaluated for burst pressure and staple malformation~gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment"
11349325|NCT04086433|OG001|Outcome|Arm B - Titan Stapler|"Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, Titan) and evaluated for burst pressure and staple malformation~gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment"
11349326|NCT04086433|EG000|Reported Event|Arm A - Echelon Stapler|"Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, Echelon) and evaluated for burst pressure and staple malformation~gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment"
11349327|NCT04086433|EG001|Reported Event|Arm B - Titan Stapler|"Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, Titan) and evaluated for burst pressure and staple malformation~gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment"
11357185|NCT03763175|OG002|Outcome|Placebo|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of placebo. Study activities will be the same across all three arms.~Placebo: A placebo will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11349328|NCT04086407|BG000|Baseline|Forehead Sensor Recording Precision Head Pitch and Roll Angle|During an overnight polysomnography, participants were coached by sleep research technologists to sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. A custom interface was developed to maintain compatibility with specific bedside polysomnography recorder auxiliary inputs. Sleep epochs were considered those where the subject slept for at least 10 minutes. Each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. Dual-axis inclinometer attached to the subject's forehead with tape: This is the first clinical trial to address OSA symptom severity and snoring as a direct function of head pitch and roll.
11349329|NCT04086407|FG000|Participant Flow|Forehead Sensor Recording Precision Head Pitch and Roll Angle|During an overnight polysomnography, participants were coached by sleep research technologists to sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions to show insensitivity to torso position. A custom interface was developed to maintain compatibility with specific bedside polysomnography recorder auxiliary inputs. Sleep epochs were considered those where the subject slept for at least 10 minutes. Each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. Dual-axis inclinometer attached to the subject's forehead with tape: This is the first clinical trial to address OSA symptom severity and snoring as a direct function of head pitch and roll
11349330|NCT04086407|OG000|Outcome|Forehead Sensor Recording Precision Head Pitch and Roll Angle|During an overnight polysomnography, participants were coached by sleep research technologists to sleep with head positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead dual axis inclinometer sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. Sleep epochs were considered those where the subject slept for at least 10 minutes and each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. This is the first clinical trial to address Obstructive Sleep Apnea (OSA) symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity.
11349331|NCT04086407|OG000|Outcome|Forehead Sensor Recording Precision Head Pitch and Roll Angle|During an overnight polysomnography, participants were coached by sleep research technologists to sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions to show insensitivity to torso position. A custom interface was developed to maintain compatibility with specific bedside polysomnography recorder auxiliary inputs. Sleep epochs were considered those where the subject slept for at least 10 minutes. Each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. Dual-axis inclinometer attached to the subject's forehead with tape: This is the first clinical trial to address OSA symptom severity and snoring as a direct function of head pitch and roll
11349332|NCT04086407|OG000|Outcome|Forehead Sensor Recording Precision Head Pitch and Roll Angle|During an overnight polysomnography, participants were coached by sleep research technologists to sleep with head positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead dual axis inclinometer sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. Sleep epochs were considered those where the subject slept for at least 10 minutes and each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. This is the first clinical trial to address OSA symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity.
11349333|NCT04086407|OG000|Outcome|Forehead Sensor Recording Precision Head Pitch and Roll Angle|During an overnight polysomnography, participants were coached by sleep research technologists to sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. A custom interface was developed to maintain compatibility with specific bedside polysomnography recorder auxiliary inputs. Sleep epochs were considered those where the subject slept for at least 10 minutes. Each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. Dual-axis inclinometer attached to the subject's forehead with tape: This is the first clinical trial to address OSA symptom severity and snoring as a direct function of head pitch and roll.
11349334|NCT04086407|EG000|Reported Event|Forehead Sensor Recording Precision Head Pitch and Roll Angle|During polysomnography participants sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's dual axis accelerometer forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. Sleep epochs were considered those where the subject slept for at least 10 minutes and each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. This is the first clinical trial to address OSA symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity. The apnea equation is based on gravitational crush force of the mass of the tongue and nearby tissue on the upper air way.
11349335|NCT04099277|BG000|Baseline|10 mg LY3435151|Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
11349336|NCT04099277|FG000|Participant Flow|10 mg LY3435151|Participants received 10 milligrams (mg) dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
11349337|NCT04099277|OG000|Outcome|10 mg LY3435151|Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
11349338|NCT04099277|EG000|Reported Event|10 mg LY3435151|Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
11349339|NCT04098809|BG000|Baseline|Catheter 16 French|"16 French urinary catheter~Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio."
11349340|NCT04098809|BG001|Baseline|Catheter 20 French|"20 French urinary catheter~Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio."
11349341|NCT04098809|BG002|Baseline|Total|Total of all reporting groups
11349342|NCT04098809|FG000|Participant Flow|Catheter 16 French|16 French urinary catheter
11349343|NCT04098809|FG001|Participant Flow|Catheter 20 French|20 French urinary catheter
11349344|NCT04098809|OG000|Outcome|Catheter 16 French|"16 French urinary catheter~Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio."
11349345|NCT04098809|OG001|Outcome|Catheter 20 French|"20 French urinary catheter~Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio."
11349346|NCT04098809|EG000|Reported Event|Catheter 16 French|"16 French urinary catheter~Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio."
11349347|NCT04098809|EG001|Reported Event|Catheter 20 French|"20 French urinary catheter~Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio."
11349348|NCT04098575|BG000|Baseline|Early Users: Patients Receiving Empagliflozin Until Mid-September 2015|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with type 2 diabetes mellitus (T2DM), registered between 2014 and 2019, receiving empagliflozin were used. Cohort 1 (early users) included only patients who received empagliflozin before the EMPA-REG OUTCOME study publication in mid-September 2015.
11349349|NCT04098575|BG001|Baseline|Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017).
11349350|NCT04098575|BG002|Baseline|Late Users: Patients Receiving Empagliflozin After Mid-January 2017|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019.
11349351|NCT04098575|BG003|Baseline|Total|Total of all reporting groups
11349352|NCT04098575|FG000|Participant Flow|Early Users: Patients Receiving Empagliflozin Until Mid-September 2015|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with type 2 diabetes mellitus (T2DM), registered between 2014 and 2019, receiving empagliflozin were used. Cohort 1 (early users) included only patients who received empagliflozin before the EMPA-REG OUTCOME study publication in mid-September 2015.
11349353|NCT04098575|FG001|Participant Flow|Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017).
11349354|NCT04098575|FG002|Participant Flow|Late Users: Patients Receiving Empagliflozin After Mid-January 2017|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019.
10887780|NCT00502697|FG000|Participant Flow|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
10887781|NCT00502697|FG001|Participant Flow|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care : Women in this group received conventional prenatal care and postpartum clinic care."
11165708|NCT01969851|FG000|Participant Flow|Lacosamide 1 Month - <4 Years|Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165709|NCT01969851|FG001|Participant Flow|Lacosamide 4 Years - <12 Years|Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165710|NCT01969851|FG002|Participant Flow|Lacosamide 12 Years - <18 Years|Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165711|NCT01969851|OG000|Outcome|Lacosamide 1 Month - <4 Years SS|Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165712|NCT01969851|OG001|Outcome|Lacosamide 4 Years - <2 Years SS|Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165713|NCT01969851|OG002|Outcome|Lacosamide 12 Years - <18 Years SS|Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165714|NCT01969851|EG000|Reported Event|Lacosamide 1 Month - <4 Years|Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165715|NCT01969851|EG001|Reported Event|Lacosamide 4 Years - <12 Years|Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165716|NCT01969851|EG002|Reported Event|Lacosamide 12 Years - <18 Years|Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
11165717|NCT01969916|BG000|Baseline|Regadenoson|Regadenoson: Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
11165718|NCT01969916|FG000|Participant Flow|Regadenoson|Regadenoson: Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
11165719|NCT01969916|OG000|Outcome|Regadenoson|Regadenoson: Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
11165720|NCT01969916|EG000|Reported Event|Regadenoson|Regadenoson: Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
11165721|NCT01970007|BG000|Baseline|Zilver Vena Venous Self-Expanding Stent|Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
11165722|NCT01970007|FG000|Participant Flow|Zilver Vena Venous Self-Expanding Stent|Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
11165723|NCT01970007|OG000|Outcome|Zilver Vena Venous Self-Expanding Stent|Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
11165724|NCT01970007|EG000|Reported Event|Zilver Vena Venous Stent|Zilver Vena Venous Stent: stenting
11165725|NCT01970176|BG000|Baseline|Tadalafil|"Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
11233905|NCT02431468|OG005|Outcome|Placebo Without Memantine|Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
11228598|NCT02391948|EG000|Reported Event|Gross Motor Function Classification System (GMFCS) Level I|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
11228599|NCT02391948|EG001|Reported Event|Gross Motor Function Classification System (GMFCS) Level II|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
11228600|NCT02391948|EG002|Reported Event|Gross Motor Function Classification System (GMFCS) Level III|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
11228601|NCT02391948|EG003|Reported Event|Gross Motor Function Classification System (GMFCS) Level IV|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
11228602|NCT02391948|EG004|Reported Event|Gross Motor Function Classification System (GMFCS) Level V|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
11228603|NCT02391961|BG000|Baseline|Dalfampridine, Then Placebo|Participants were randomized to receive dalfampridine 10 mg tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive placebo tablet twice a day (matching dalfampridine 10 mg tablet) for 4 weeks (Second Intervention).
11228604|NCT02391961|BG001|Baseline|Placebo, Then Dalfampridine|Participants were randomized to receive placebo tablet (matching dalfampridine 10 mg tablet) twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg tablet twice a day for 4 weeks (Second Intervention).
11228605|NCT02391961|BG002|Baseline|Total|Total of all reporting groups
11228606|NCT02391961|FG000|Participant Flow|Dalfampridine, Then Placebo|Participants were randomized to receive dalfampridine 10 mg tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive placebo tablet twice a day (matching dalfampridine 10 mg tablet) for 4 weeks (Second Intervention).
11228607|NCT02391961|FG001|Participant Flow|Placebo, Then Dalfampridine|Participants were randomized to receive placebo tablet (matching dalfampridine 10 mg tablet) twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg tablet twice a day for 4 weeks (Second Intervention).
11228608|NCT02391961|OG000|Outcome|Dalfampridine|"Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.~Here we report results from participants while on dalfampridine."
11228609|NCT02391961|OG001|Outcome|Placebo|"Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.~Here we report results from participants while on placebo."
11228610|NCT02391961|EG000|Reported Event|Dalfampridine|Participants received dalfampridine 10 mg tablet twice a day for 4 weeks.
11228611|NCT02391961|EG001|Reported Event|Placebo|Participants received placebo tablet (matching dalfampridine 10 mg tablet) twice a day for 4 weeks.
11228612|NCT02391987|BG000|Baseline|Tele-Monitoring|"Tele-monitoring and health coaching in addition to standard health care~Tele-monitoring and health coaching: Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.~Health Coaching involves a team of health care professionals including a registered nurse (RN) . The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management."
11228613|NCT02391987|BG001|Baseline|Standard Care|Standard care is defined as Heart Failure (HF) care based on current American College of Cardiology (ACC) and American Heart Association (AHA) HF guidelines implemented and orchestrated by a cardiologist and support staff at the participating institution.
11228614|NCT02391987|BG002|Baseline|Total|Total of all reporting groups
11228615|NCT02391987|FG000|Participant Flow|Tele-Monitoring|"Tele-monitoring and health coaching in addition to standard health care~Tele-monitoring and health coaching: Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.~Health Coaching involves a team of health care professionals including a registered nurse (RN) . The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management."
11228616|NCT02391987|FG001|Participant Flow|Standard Care|Standard care is defined as Heart Failure (HF) care based on current American College of Cardiology (ACC) and American Heart Association (AHA) HF guidelines implemented and orchestrated by a cardiologist and support staff at the participating institution.
11228617|NCT02391987|OG000|Outcome|Tele-Monitoring|"Tele-monitoring and health coaching in addition to standard health care~Tele-monitoring and health coaching: Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.~Health Coaching involves a team of health care professionals including a registered nurse (RN) . The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management."
11228618|NCT02391987|OG001|Outcome|Standard Care|Standard care is defined as Heart Failure (HF) care based on current American College of Cardiology (ACC) and American Heart Association (AHA) HF guidelines implemented and orchestrated by a cardiologist and support staff at the participating institution.
11228619|NCT02391987|EG000|Reported Event|Tele-Monitoring|"Tele-monitoring and health coaching in addition to standard health care~Tele-monitoring and health coaching: Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.~Health Coaching involves a team of health care professionals including a registered nurse (RN) . The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management."
11228620|NCT02391987|EG001|Reported Event|Standard Care|Standard care is defined as Heart Failure (HF) care based on current American College of Cardiology (ACC) and American Heart Association (AHA) HF guidelines implemented and orchestrated by a cardiologist and support staff at the participating institution.
11228621|NCT02392000|BG000|Baseline|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
11228622|NCT02392000|FG000|Participant Flow|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
11228623|NCT02392000|OG000|Outcome|WatchPAT and CBT-i Coach Mobile App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
11228624|NCT02392000|OG000|Outcome|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
11228625|NCT02392000|EG000|Reported Event|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
11228626|NCT02392104|BG000|Baseline|Intervention Arm|"All patients in the study will be in the intervention arm.~Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."
11228627|NCT02392104|FG000|Participant Flow|Extended INR Follow-up Interval Group|"All patients in the study will be in the intervention arm.~Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."
11228628|NCT02392104|OG000|Outcome|Intervention Arm|"All patients in the study will be in the intervention arm.~Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."
11228629|NCT02392104|EG000|Reported Event|Intervention Arm|"All patients in the study will be in the intervention arm.~Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."
11228630|NCT02392195|BG000|Baseline|Single Arm; Non-interventional|"A convenience sample of infants born at term gestation, </= 6 months of age with significant Deformational Plagiocephaly (DP) (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study~Non-interventional: Observational"
11228631|NCT02392195|FG000|Participant Flow|Single Arm; Non-interventional|"A convenience sample of 10-15 infants born at term gestation, that are </= 6 months of age with significant DP (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study~Non-interventional: Observational"
11228632|NCT02392195|OG000|Outcome|Single Arm; Non-interventional|"A convenience sample of infants born at term gestation, that are </= 6 months of age with significant DP (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study~Non-interventional: Observational"
11228633|NCT02392195|EG000|Reported Event|Single Arm; Non-interventional|"A convenience sample of infants born at term gestation, that are </= 6 months of age with significant DP (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study~Non-interventional: Observational"
11228634|NCT02392208|BG000|Baseline|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
11228635|NCT02392208|FG000|Participant Flow|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
11228636|NCT02392208|OG000|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
11228637|NCT02392208|EG000|Reported Event|Telavancin Before Hemodialysis|"Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.~Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV).~Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations."
11228638|NCT02392208|EG001|Reported Event|Telavancin After Hemodialysis|"Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.~Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV).~Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations."
11228639|NCT02392234|BG000|Baseline|First VX- 661/IVA, Then IVA|VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228640|NCT02392234|BG001|Baseline|First VX-661/IVA, Then Placebo|VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228641|NCT02392234|BG002|Baseline|First IVA, Then Placebo|IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228642|NCT02392234|BG003|Baseline|First IVA, Then VX- 661/IVA|IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228643|NCT02392234|BG004|Baseline|First Placebo, Then VX- 661/IVA|Placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 followed by VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228644|NCT02392234|BG005|Baseline|First Placebo, Then IVA|Placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 followed by IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228645|NCT02392234|BG006|Baseline|Total|Total of all reporting groups
11228646|NCT02392234|FG000|Participant Flow|First VX-661/IVA, Then IVA|VX-661 100 milligram (mg) plus IVA 150 mg fixed dose combination (FDC) tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228647|NCT02392234|FG001|Participant Flow|First VX-661/IVA, Then Placebo|VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228648|NCT02392234|FG002|Participant Flow|First IVA, Then Placebo|IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228649|NCT02392234|FG003|Participant Flow|First IVA, Then VX- 661/IVA|IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11165726|NCT01970176|BG001|Baseline|Placebo|"Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
11165727|NCT01970176|BG002|Baseline|Total|Total of all reporting groups
11165728|NCT01970176|FG000|Participant Flow|Tadalafil|"Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
11165729|NCT01970176|FG001|Participant Flow|Placebo|"Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
11165730|NCT01970176|OG000|Outcome|Tadalafil|"Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
11165731|NCT01970176|OG001|Outcome|Placebo|"Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
11165732|NCT01970176|EG000|Reported Event|Tadalafil|"Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
11165733|NCT01970176|EG001|Reported Event|Placebo|"Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
11165734|NCT01970241|BG000|Baseline|NPH With Corticosteroid Dose|"Receive NPH with each corticosteroid dose during the study duration (2-5 days).~Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg~NPH: NPH given per study table based on steroid dose and patient weight in kg.~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11165735|NCT01970241|BG001|Baseline|Control|"Receive usual care with background insulin and correction factor for duration of study (2-5 days)~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11165736|NCT01970241|BG002|Baseline|Total|Total of all reporting groups
11165737|NCT01970241|FG000|Participant Flow|NPH With Each Steroid Dose|"Receive NPH with each corticosteroid dose during the study duration (2-5 days).~Low dose corticosteroids eating: 0.2 units NPH/kg High dose corticosteroids eating: 0.3 units NPH/kg Low dose corticosteroids NPO: 0.1 units NPH/kg High dose corticosteroids NPO: 0.15 units NPH/kg~NPH: NPH given per study table based on steroid dose and patient weight in kg.~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.~Low dose corticosteroids: Prednisone 10 - 40 mg daily or equivalent corticosteroid dose.~High dose corticosteroids: Prednisone > 40 mg daily or equivalent corticosteroid dose."
11165738|NCT01970241|FG001|Participant Flow|Control|"Receive usual care with background insulin and correction factor for duration of study (2-5 days)~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11165739|NCT01970241|OG000|Outcome|NPH With Corticosteroid|"Receive NPH with each corticosteroid dose during the study duration (2-5 days).~Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg~NPH: NPH given per study table based on steroid dose and patient weight in kg.~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11228650|NCT02392234|FG004|Participant Flow|First Placebo, Then VX- 661/IVA|Placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 followed by VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228651|NCT02392234|FG005|Participant Flow|First Placebo, Then IVA|Placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 followed by IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.
11228652|NCT02392234|OG000|Outcome|Placebo|Placebo matched to VX-661/Ivacaftor (IVA) fixed dose combination (FDC) tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 and 2.
11228653|NCT02392234|OG001|Outcome|Ivacaftor|IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.
11228654|NCT02392234|OG002|Outcome|VX-661/IVA|VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.
11228655|NCT02392234|OG002|Outcome|VX-661/IVA|IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.
11228656|NCT02392234|OG000|Outcome|VX-661/IVA|VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.
11228657|NCT02392234|OG000|Outcome|Ivacaftor|IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.
11228658|NCT02392234|EG000|Reported Event|Placebo|Placebo matched to VX-661/Ivacaftor (IVA) fixed dose combination (FDC) tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 and 2.
11228659|NCT02392234|EG001|Reported Event|Ivacaftor|IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.
11228660|NCT02392234|EG002|Reported Event|VX-661/IVA|VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.
11228661|NCT02392247|BG000|Baseline|Cardiac Surgery Patients|Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. Paired blood samples were assessed by thromboelastography (TEG; current care option) and by Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry
11228662|NCT02392247|FG000|Participant Flow|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
11228663|NCT02392247|OG000|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
11228664|NCT02392247|EG000|Reported Event|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry~Blood specimen collection"
11228665|NCT02392286|BG000|Baseline|Weight-based|"Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.~Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy."
11228666|NCT02392286|BG001|Baseline|Fixed Dose|"Corticosteroid dose fixed at equivalent to 40mg prednisone daily.~Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy."
11228667|NCT02392286|BG002|Baseline|Total|Total of all reporting groups
11228668|NCT02392286|FG000|Participant Flow|Weight-based|"Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.~Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy."
11228669|NCT02392286|FG001|Participant Flow|Fixed Dose|"Corticosteroid dose fixed at equivalent to 40mg prednisone daily.~Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy."
11228670|NCT02392286|OG000|Outcome|Weight-based|"Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.~Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy."
11228671|NCT02392286|OG001|Outcome|Fixed Dose|"Corticosteroid dose fixed at equivalent to 40mg prednisone daily.~Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy."
11228672|NCT02392286|EG000|Reported Event|Weight-based|"Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.~Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy."
11228673|NCT02392286|EG001|Reported Event|Fixed Dose|"Corticosteroid dose fixed at equivalent to 40mg prednisone daily.~Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy."
11228674|NCT02392351|BG000|Baseline|Renal Denervation|"Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).~Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator"
11228675|NCT02392351|BG001|Baseline|Masked Procedure|"Percutaneous renal angiography~Renal Angiography: Percutaneous renal angiography"
11228676|NCT02392351|BG002|Baseline|Total|Total of all reporting groups
11228677|NCT02392351|FG000|Participant Flow|Renal Denervation|"Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).~Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator"
11228678|NCT02392351|FG001|Participant Flow|Masked Procedure|"Percutaneous renal angiography~Renal Angiography: Percutaneous renal angiography"
11228679|NCT02392351|OG000|Outcome|Renal Denervation|"Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).~Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator"
11228680|NCT02392351|OG001|Outcome|Masked Procedure|"Percutaneous renal angiography~Renal Angiography: Percutaneous renal angiography"
11228681|NCT02392351|EG000|Reported Event|Treatment Group|"Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System)~Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator Through 6 Months"
11228682|NCT02392351|EG001|Reported Event|Masked Procedure - Control Group|"Percutaneous renal angiography~Renal Angiography: Percutaneous renal angiography"
11228683|NCT02392403|BG000|Baseline|Nucleus CI532 Cochlear Implant|Single arm study. All participants received CI532.
11228684|NCT02392403|FG000|Participant Flow|Nucleus CI532 Cochlear Implant|Single arm study. All participants received CI532.
11228685|NCT02392403|OG000|Outcome|Nucleus CI532 Cochlear Implant|Single arm study. All participants received CI532.
11228686|NCT02392403|EG000|Reported Event|Nucleus CI532 Cochlear Implant|Single arm study. All participants received CI532.
11228687|NCT02392481|BG000|Baseline|Healthy Volunteers|This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
11228688|NCT02392481|BG001|Baseline|Mild Asthma|Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
11228689|NCT02392481|BG002|Baseline|Moderate Asthma|Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
11228690|NCT02392481|BG003|Baseline|Severe Asthma|Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
11228691|NCT02392481|BG004|Baseline|Total|Total of all reporting groups
11228692|NCT02392481|FG000|Participant Flow|Healthy Volunteers|This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
11228693|NCT02392481|FG001|Participant Flow|Mild Asthma|Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
11228694|NCT02392481|FG002|Participant Flow|Moderate Asthma|Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
11228695|NCT02392481|FG003|Participant Flow|Severe Asthma|Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
11228696|NCT02392481|OG000|Outcome|Healthy Volunteers|This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
11228697|NCT02392481|OG001|Outcome|Mild Asthma|Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
11228698|NCT02392481|OG002|Outcome|Moderate Asthma|Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
11228699|NCT02392481|OG003|Outcome|Severe Asthma|Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
11228700|NCT02392481|EG000|Reported Event|Healthy Volunteers|This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
11228701|NCT02392481|EG001|Reported Event|Mild Asthma|Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
11228702|NCT02392481|EG002|Reported Event|Moderate Asthma|Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
11228703|NCT02392481|EG003|Reported Event|Severe Asthma|Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
11228704|NCT02392494|BG000|Baseline|MK-1075 100 mg (Panel A)|HCV-infected participants receive a single 100 mg dose of MK-1075.
11228705|NCT02392494|BG001|Baseline|MK-1075 200 mg (Panel B)|HCV-infected participants receive a single 200 mg dose of MK-1075.
11228706|NCT02392494|BG002|Baseline|MK-1075 400 mg (Panel C)|HCV-infected participants receive a single 400 mg dose of MK-1075.
11228707|NCT02392494|BG003|Baseline|Total|Total of all reporting groups
11228708|NCT02392494|FG000|Participant Flow|MK-1075 100 mg (Panel A)|HCV-infected participants receive a single 100 mg dose of MK-1075.
11228709|NCT02392494|FG001|Participant Flow|MK-1075 200 mg (Panel B)|HCV-infected participants receive a single 200 mg dose of MK-1075.
11228710|NCT02392494|FG002|Participant Flow|MK-1075 400 mg (Panel C)|HCV-infected participants receive a single 400 mg dose of MK-1075.
11228711|NCT02392494|FG003|Participant Flow|MK-1075 800 mg (Panel D)|HCV-infected participants were to receive a single 800 mg dose of MK-1075. No participants were enrolled in this arm.
11228712|NCT02392494|OG000|Outcome|MK-1075 100 mg (Panel A)|HCV-infected participants receive a single 100 mg dose of MK-1075.
11228713|NCT02392494|OG001|Outcome|MK-1075 200 mg (Panel B)|HCV-infected participants receive a single 200 mg dose of MK-1075.
11228714|NCT02392494|OG002|Outcome|MK-1075 400 mg (Panel C)|HCV-infected participants receive a single 400 mg dose of MK-1075.
11228715|NCT02392494|EG000|Reported Event|MK-1075 100 mg (Panel A)|HCV-infected participants receive a single 100 mg dose of MK-1075.
11228716|NCT02392494|EG001|Reported Event|MK-1075 200 mg (Panel B)|HCV-infected participants receive a single 200 mg dose of MK-1075.
11228717|NCT02392494|EG002|Reported Event|MK-1075 400 mg (Panel C)|HCV-infected participants receive a single 400 mg dose of MK-1075.
11228718|NCT02392507|BG000|Baseline|Necitumumab + Nab-Paclitaxel + Carboplatin|"Induction: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles.~Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles).~Participants may continue to receive treatment until discontinuation criteria are met."
11228719|NCT02392507|FG000|Participant Flow|Necitumumab + Nab-Paclitaxel + Carboplatin|"Induction: Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 milligram per square meter (mg/m²) on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC (area under curve) 6 milligram per milliliter over time (mg*min/mL) on day 1 of each cycle, for a maximum of 4 cycles.~Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles).~Participants may continue to receive treatment until discontinuation criteria are met."
11228720|NCT02392507|OG000|Outcome|Necitumumab + Nab-Paclitaxel + Carboplatin|"Induction: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles.~Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles).~Participants may continue to receive treatment until discontinuation criteria are met."
11228721|NCT02392507|OG000|Outcome|Necitumumab|Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles).
11228722|NCT02392507|OG001|Outcome|Carboplatin|Carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles.
11228723|NCT02392507|OG002|Outcome|Paclitaxel|Nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle.
11228724|NCT02392507|OG000|Outcome|Necitumumab|Necitumumab administered IV 800 mg on day 1 and 8 of each cycle (3 week cycles).
11228725|NCT02392507|EG000|Reported Event|Necitumumab + Nab-paclitaxel + Carboplatin: Induction Phase|Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11228726|NCT02392507|EG001|Reported Event|Necitumumab + Nab-paclitaxel: Maintenance Phase|Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11228727|NCT02392559|BG000|Baseline|Placebo|Matching subcutaneous injection QM
11228728|NCT02392559|BG001|Baseline|EvoMab 420 mg QM|Evolocumab subcutaneous injection QM
11228729|NCT02392559|BG002|Baseline|Total|Total of all reporting groups
11228730|NCT02392559|FG000|Participant Flow|Placebo|Matching subcutaneous injection QM
11228731|NCT02392559|FG001|Participant Flow|EvoMab 420 mg QM|Evolocumab subcutaneous injection QM
11228732|NCT02392559|OG000|Outcome|Placebo|Matching subcutaneous injection QM
11228733|NCT02392559|OG001|Outcome|EvoMab 420 mg QM|Evolocumab subcutaneous injection QM
11228734|NCT02392559|OG000|Outcome|EvoMab 420 mg QM|Evolocumab subcutaneous injection QM
11228735|NCT02392559|EG000|Reported Event|Placebo SC QM|Matching subcutaneous injection QM
11228736|NCT02392559|EG001|Reported Event|EvoMab 420 mg SC QM|Evolocumab subcutaneous injection QM
11228737|NCT02392611|BG000|Baseline|Monotherapy: Alobresib 0.6 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228738|NCT02392611|BG001|Baseline|Monotherapy: Alobresib 1.4 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228739|NCT02392611|BG002|Baseline|Monotherapy: Alobresib 2 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228740|NCT02392611|BG003|Baseline|Monotherapy: Alobresib 3 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228741|NCT02392611|BG004|Baseline|Monotherapy: Alobresib 4 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228742|NCT02392611|BG005|Baseline|Monotherapy: Alobresib 6 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228743|NCT02392611|BG006|Baseline|Combination Therapy: Alobresib 2 mg + Exemestane|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.
10887782|NCT00502697|OG000|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
11349355|NCT04098575|OG000|Outcome|Early Users: Patients Receiving Empagliflozin Until Mid-September 2015|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with type 2 diabetes mellitus (T2DM), registered between 2014 and 2019, receiving empagliflozin were used. Cohort 1 (early users) included only patients who received empagliflozin before the EMPA-REG OUTCOME study publication in mid-September 2015.
11349356|NCT04098575|OG001|Outcome|Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017).
11349357|NCT04098575|OG002|Outcome|Late Users: Patients Receiving Empagliflozin After Mid-January 2017|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019.
11349358|NCT04098575|EG000|Reported Event|Early Users: Patients Receiving Empagliflozin Until Mid-September 2015|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with type 2 diabetes mellitus (T2DM), registered between 2014 and 2019, receiving empagliflozin were used. Cohort 1 (early users) included only patients who received empagliflozin before the EMPA-REG OUTCOME study publication in mid-September 2015.
11349359|NCT04098575|EG001|Reported Event|Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017).
11349360|NCT04098575|EG002|Reported Event|Late Users: Patients Receiving Empagliflozin After Mid-January 2017|Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019.
11349361|NCT04098458|BG000|Baseline|NDURE|"NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels.~NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit."
11349362|NCT04098458|FG000|Participant Flow|NDURE|"Navigation for Disparities and Untimely Radiation thErapy (NDURE) is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent postoperative radiation therapy (PORT). NDURE key functions include: 1) Improve patient knowledge about Guidelines for timely PORT and associated care processes; 2) Minimize the burden of travel for HNSCC care; 3) Improve communication between patient and providers regarding intentions and goals for timely, guideline-adherent PORT; 4) Enhance care coordination between care teams during care transitions and about treatment sequelae; 5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; 6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care.~Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each. The three NDURE sessions coincide with the pre-surgical consult, hospital discharge, and first postoperative visit, time points chosen to facilitate case identification and coordination across care transitions. During each NDURE session, the navigator delivers patient education and creates or updates the PORT Care Plan. Referral tracking and follow-up occurs through asynchronous contact between the navigator, patient, and healthcare organizations between NDURE sessions."
11349363|NCT04098458|OG000|Outcome|NDURE|"NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels.~NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit."
11165740|NCT01970241|OG001|Outcome|Control|"Receive usual care with background insulin and correction factor for duration of study (2-5 days)~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11165741|NCT01970241|OG000|Outcome|NPH Insulin (Intervention Group)|"Receive NPH with each corticosteroid dose during the study duration (1-5 days).~Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg~NPH: NPH given per study table based on steroid dose and patient weight in kg.~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11165742|NCT01970241|OG001|Outcome|Control|"Receive usual care with background insulin and correction factor for duration of study (1-5 days)~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11165743|NCT01970241|EG000|Reported Event|NPH With Corticosteroid|"Receive NPH with each corticosteroid dose during the study duration (2-5 days).~Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg~NPH: NPH given per study table based on steroid dose and patient weight in kg.~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11165744|NCT01970241|EG001|Reported Event|Control|"Receive usual care with background insulin and correction factor for duration of study (2-5 days)~Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration."
11165745|NCT01970371|BG000|Baseline|Plazomicin in Combination With Meropenem or Tigecycline|Cohort 1: Patients received 15 mg/kg plazomicin therapy (plus meropenem or tigecycline) as a 30-minute IV infusion once daily for 7 to 14 days.
11165746|NCT01970371|BG001|Baseline|Colistin in Combination With Meropenem or Tigecycline|Cohort 1: Patients received a 5 mg/kg IV loading dose (300 mg maximum) colistin (plus meropenem or tigecycline) followed by a 5 mg/kg/d maintenance dose divided into q8h or q12h for 7 to 14 days.
11165747|NCT01970371|BG002|Baseline|Plazomicin in Combination With Adjunctive Antibiotic|Cohort 2: Patients received 15 mg/kg as a 30 minute IV infusion once daily. BSI, HABP, or VABP patients received plazomicin and any supplemental antibiotic therapy, according to Investigator's choice, for 7 to 14 days. cUTI or AP patients received plazomicin monotherapy only for 4 to 7 days with an option to switch to oral therapy on or after Day 5.
11165748|NCT01970371|BG003|Baseline|Total|Total of all reporting groups
11165749|NCT01970371|FG000|Participant Flow|Plazomicin in Combination With Meropenem or Tigecycline|Cohort 1: Patients received 15 milligram per killogram (mg/kg) plazomicin therapy (plus meropenem or tigecycline) as a 30-minute intravenous (IV) infusion once daily for 7 to 14 days.
11165750|NCT01970371|FG001|Participant Flow|Colistin in Combination With Meropenem or Tigecycline|Cohort 1: Patients received a 5 mg/kg IV loading dose (300 mg maximum) colistin (plus meropenem or tigecycline) followed by a 5 mg/kg/d maintenance dose divided into every 8 hours (q8h) or every 12 hours (q12h) for 7 to 14 days.
11165751|NCT01970371|FG002|Participant Flow|Plazomicin in Combination With Adjunctive Antibiotic|Cohort 2: Patients received 15 mg/kg as a 30 minute IV infusion once daily. Bloodstream infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator associated bacterial pneumonia (VABP) patients received plazomicin and any supplemental antibiotic therapy, according to Investigator's choice, for 7 to 14 days. Complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) patients received plazomicin monotherapy only for 4 to 7 days with an option to switch to oral therapy on or after Day 5.
11165752|NCT01970371|OG000|Outcome|Plazomicin in Combination With Meropenem or Tigecycline|Cohort 1: Patients received 15 mg/kg plazomicin therapy (plus meropenem or tigecycline) as a 30-minute IV infusion once daily for 7 to 14 days.
11165753|NCT01970371|OG001|Outcome|Colistin in Combination With Meropenem or Tigecycline|Cohort 1: Patients received a 5 mg/kg IV loading dose (300 mg maximum) colistin (plus meropenem or tigecycline) followed by a 5 mg/kg/d maintenance dose divided into q8h or q12h for 7 to 14 days.
11165754|NCT01970371|OG001|Outcome|Plazomicin in Combination With Adjunctive Antibiotic|Cohort 2: Patients received 15 mg/kg as a 30 minute IV infusion once daily. BSI, HABP, or VABP patients received plazomicin and any supplemental antibiotic therapy, according to Investigator's choice, for 7 to 14 days. cUTI or AP patients received plazomicin monotherapy only for 4 to 7 days with an option to switch to oral therapy on or after Day 5.
11165755|NCT01970371|OG002|Outcome|Plazomicin in Combination With Adjunctive Antibiotic|Cohort 2: Patients received 15 mg/kg as a 30 minute IV infusion once daily. BSI, HABP, or VABP patients received plazomicin and any supplemental antibiotic therapy, according to Investigator's choice, for 7 to 14 days. cUTI or AP patients received plazomicin monotherapy only for 4 to 7 days with an option to switch to oral therapy on or after Day 5.
11165756|NCT01970371|OG000|Outcome|Plazomicin|All patients who received plazomicin throughout the study.
11165757|NCT01970371|EG000|Reported Event|Plazomicin in Combination With Meropenem or Tigecycline|Cohort 1: Patients received 15 mg/kg plazomicin therapy (plus meropenem or tigecycline) as a 30-minute IV infusion once daily for 7 to 14 days.
11165758|NCT01970371|EG001|Reported Event|Colistin in Combination With Meropenem or Tigecycline|Cohort 1: Patients received a 5 mg/kg IV loading dose (300 mg maximum) colistin (plus meropenem or tigecycline) followed by a 5 mg/kg/d maintenance dose divided into q8h or q12h for 7 to 14 days.
11165759|NCT01970371|EG002|Reported Event|Plazomicin in Combination With Adjunctive Antibiotic|Cohort 2: Patients received 15 mg/kg as a 30 minute IV infusion once daily. BSI, HABP, or VABP patients received plazomicin and any supplemental antibiotic therapy, according to Investigator's choice, for 7 to 14 days. cUTI or AP patients received plazomicin monotherapy only for 4 to 7 days with an option to switch to oral therapy on or after Day 5.
11165760|NCT01970397|BG000|Baseline|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
11165761|NCT01970397|BG001|Baseline|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
11165762|NCT01970397|BG002|Baseline|Total|Total of all reporting groups
11165763|NCT01970397|FG000|Participant Flow|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
11165764|NCT01970397|FG001|Participant Flow|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
11165765|NCT01970397|OG000|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
11165766|NCT01970397|OG001|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
11165767|NCT01970397|EG000|Reported Event|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
11165768|NCT01970397|EG001|Reported Event|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
11165769|NCT01970475|BG000|Baseline|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
11165770|NCT01970475|BG001|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
11165771|NCT01970475|BG002|Baseline|Total|Total of all reporting groups
11165772|NCT01970475|FG000|Participant Flow|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
11165773|NCT01970475|FG001|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
11165774|NCT01970475|OG000|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
11165775|NCT01970475|OG001|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
11165776|NCT01970475|EG000|Reported Event|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
11165777|NCT01970475|EG001|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
11165778|NCT01970488|BG000|Baseline|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
11165779|NCT01970488|BG001|Baseline|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
11165780|NCT01970488|BG002|Baseline|Total|Total of all reporting groups
11165781|NCT01970488|FG000|Participant Flow|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
11165782|NCT01970488|FG001|Participant Flow|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
11165783|NCT01970488|FG002|Participant Flow|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
11165784|NCT01970488|FG003|Participant Flow|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
11165785|NCT01970488|FG004|Participant Flow|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
11165786|NCT01970488|OG000|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
11165787|NCT01970488|OG001|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
11165788|NCT01970488|OG000|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
11165789|NCT01970488|OG001|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
11165790|NCT01970488|OG002|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
11165791|NCT01970488|OG002|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
11165792|NCT01970488|OG003|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
11165793|NCT01970488|OG004|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
11165794|NCT01970488|EG000|Reported Event|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
11165795|NCT01970488|EG001|Reported Event|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
11165796|NCT01970488|EG002|Reported Event|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
11165797|NCT01970488|EG003|Reported Event|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
11165798|NCT01970488|EG004|Reported Event|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
11165799|NCT01970527|BG000|Baseline|Bone or Lung Index Lesion|Participants with bone or lung index lesion with prescription dose per fraction to the Planning Target Volume (PTV) of 8 Gy per fraction. The total dose for dose level 1 (our starting dose level) will be 24 Gy over 3 fractions. If we encounter a dose limiting toxicity, we will then reduce our total dose to dose level -1. The total dose for dose level -1 will be 12 Gy over 2 fractions.
11165800|NCT01970527|BG001|Baseline|Liver or Subcutaneous Index Lesion|Participants with liver or subcutaneous index lesion with prescription dose per fraction to the Planning Target Volume (PTV) of 6 Gy per fraction. The total dose for dose level 1 (our starting dose level) will be 18 Gy over 3 fractions. If we encounter a dose limiting toxicity, we will then reduce our total dose to dose level -1. The total dose for dose level -1 will be 12 Gy over 2 fractions.
11165801|NCT01970527|BG002|Baseline|Total|Total of all reporting groups
11165802|NCT01970527|FG000|Participant Flow|Bone or Lung Index Lesion|Participants with bone or lung index lesion with prescription dose per fraction to the Planning Target Volume (PTV) of 8 Gy per fraction. The total dose for dose level 1 (our starting dose level) will be 24 Gy over 3 fractions. If we encounter a dose limiting toxicity, we will then reduce our total dose to dose level -1. The total dose for dose level -1 will be 12 Gy over 2 fractions.
11165803|NCT01970527|FG001|Participant Flow|Liver or Subcutaneous Index Lesion|Participants with liver or subcutaneous index lesion with prescription dose per fraction to the Planning Target Volume (PTV) of 6 Gy per fraction. The total dose for dose level 1 (our starting dose level) will be 18 Gy over 3 fractions. If we encounter a dose limiting toxicity, we will then reduce our total dose to dose level -1. The total dose for dose level -1 will be 12 Gy over 2 fractions.
11165804|NCT01970527|OG000|Outcome|Stable Disease|Patients with Stable disease at any point in follow up
11165805|NCT01970527|OG000|Outcome|Immune Naive|Previously untreated metastatic melanoma patients
11165806|NCT01970527|OG001|Outcome|Immune Resistant|Previously treated metastatic melanoma patients
11165807|NCT01970527|OG000|Outcome|Bone or Lung Index Lesion|Participants with bone or lung index lesion with prescription dose per fraction to the Planning Target Volume (PTV) of 8 Gy per fraction. The total dose for dose level 1 (our starting dose level) will be 24 Gy over 3 fractions. If we encounter a dose limiting toxicity, we will then reduce our total dose to dose level -1. The total dose for dose level -1 will be 12 Gy over 2 fractions.
11165808|NCT01970527|OG001|Outcome|Liver or Subcutaneous Index Lesion|Participants with liver or subcutaneous index lesion with prescription dose per fraction to the Planning Target Volume (PTV) of 6 Gy per fraction. The total dose for dose level 1 (our starting dose level) will be 18 Gy over 3 fractions. If we encounter a dose limiting toxicity, we will then reduce our total dose to dose level -1. The total dose for dose level -1 will be 12 Gy over 2 fractions.
11165809|NCT01970527|EG000|Reported Event|Bone or Lung Index Lesion|Participants with bone or lung index lesion with prescription dose per fraction to the Planning Target Volume (PTV) of 8 Gy per fraction. The total dose for dose level 1 (our starting dose level) will be 24 Gy over 3 fractions. If we encounter a dose limiting toxicity, we will then reduce our total dose to dose level -1. The total dose for dose level -1 will be 12 Gy over 2 fractions.
11165810|NCT01970527|EG001|Reported Event|Liver or Subcutaneous Index Lesion|Participants with liver or subcutaneous index lesion with prescription dose per fraction to the Planning Target Volume (PTV) of 6 Gy per fraction. The total dose for dose level 1 (our starting dose level) will be 18 Gy over 3 fractions. If we encounter a dose limiting toxicity, we will then reduce our total dose to dose level -1. The total dose for dose level -1 will be 12 Gy over 2 fractions.
11165811|NCT01970540|BG000|Baseline|Cohort A|DOX: 50 mg/m² q3wk immediately followed by PM01183. The dose escalation scheme was: 3.0, 3.5, 5.0, 6.0, 7.0 mg FD
11165812|NCT01970540|BG001|Baseline|Cohort B: SCLC 2nd Line|Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 Immediately followed by PM01183: 2.0 mg/m2.
11165813|NCT01970540|BG002|Baseline|Cohort B: Endometrial|Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
11165814|NCT01970540|BG003|Baseline|Total|Total of all reporting groups
11165815|NCT01970540|FG000|Participant Flow|Cohort A|"DOX: 50 mg/m² q3wk immediately followed by PM01183. The dose escalation scheme was: 3.0, 3.5, 5.0, 6.0, 7.0 mg FD~lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.~Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate."
11165816|NCT01970540|FG001|Participant Flow|Cohort B: SCLC 2nd Line|"Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.~lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.~Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate.~SCLC, small cell lung cancer"
11349364|NCT04098458|OG000|Outcome|NDURE|"NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE consists of 6 key functions including (1) Improve patient knowledge about Guidelines for timely PORT and associated care processes: (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patient and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care.~Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each. The three NDURE sessions coincide with the pre-surgical consult, hospital discharge, and first postoperative visit, time points chosen to facilitate case identification and coordination across care transitions. During each NDURE session, the navigator delivers patient education and creates or updates the PORT Care Plan. Referral tracking and follow-up occurs through asynchronous contact between the navigator, patient, and healthcare organizations between NDURE sessions."
11349365|NCT04098458|EG000|Reported Event|NDURE|"NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE consists of 6 key functions including (1) Improve patient knowledge about Guidelines for timely PORT and associated care processes: (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patient and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care.~Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each. The three NDURE sessions coincide with the pre-surgical consult, hospital discharge, and first postoperative visit, time points chosen to facilitate case identification and coordination across care transitions. During each NDURE session, the navigator delivers patient education and creates or updates the PORT Care Plan. Referral tracking and follow-up occurs through asynchronous contact between the navigator, patient, and healthcare organizations between NDURE sessions."
11349366|NCT04095286|BG000|Baseline|All Study Participants|Participants received a single oral dose of AMB tablet (administered as 5 x 1 mg tablet) dispersed in water (F1) or a single dose of AMB oral tablet (administered as 5 x 1 mg tablet) administered intact (F2) or a single oral dose of reference AMB tablet (R) administered as 1 x 5 mg tablet in the following six sequences F1/F2/R, F2/R/F1, R/F1/F2, F1/R/F2, F2/F1/R and R/F2/F1.
11349367|NCT04095286|FG000|Participant Flow|AMB Dispersed in Water/AMB Oral Tablet/Reference AMB|Participants received a single oral dose of 5 milligram (mg) (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single oral dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
11349368|NCT04095286|FG001|Participant Flow|AMB Oral Tablet/Reference AMB/AMB Dispersed in Water|Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
11349369|NCT04095286|FG002|Participant Flow|Reference AMB/AMB Dispersed in Water/AMB Oral Tablet|Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
11349370|NCT04095286|FG003|Participant Flow|AMB Dispersed in Water/Reference AMB/AMB Oral Tablet|Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water during treatment period 1 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
11349371|NCT04095286|FG004|Participant Flow|AMB Oral Tablet/AMB Dispersed in Water/Reference AMB|Participants received a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 2 followed by a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
11349372|NCT04095286|FG005|Participant Flow|Reference AMB/AMB Oral/AMB Dispersed in Water|Participants received a single dose of reference 5 mg (administered as 1 x 5 mg tablet) AMB oral tablet during treatment period 1 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB oral tablet administered intact in treatment period 2 followed by a single dose of 5 mg (administered as 5 x 1 mg tablet) AMB tablet dispersed in water in treatment period 3. The treatment periods were separated by a washout period of minimum 7 days.
11349373|NCT04095286|OG000|Outcome|AMB Dispersed in Water|Participants received a single dose of 5 mg AMB tablet dispersed in water and administered orally
11349374|NCT04095286|OG001|Outcome|AMB Oral Tablet|Participants received a single dose of 5 mg AMB tablet administered intact orally
11349375|NCT04095286|OG002|Outcome|Reference AMB|Participants received a single dose of reference 5 mg AMB tablet administered orally
11349376|NCT04095286|EG000|Reported Event|AMB Dispersed in Water|Participants received a single dose of 5 mg AMB tablet dispersed in water and administered orally
11349377|NCT04095286|EG001|Reported Event|AMB Oral Tablet|Participants received a single dose of 5 mg AMB tablet administered intact orally
11349378|NCT04095286|EG002|Reported Event|Reference AMB|Participants received a single dose of reference 5 mg AMB tablet administered orally
11349379|NCT04094883|BG000|Baseline|4CMenB Vaccine|"Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.~Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5."
11349380|NCT04094883|FG000|Participant Flow|4CMenB Vaccine|"Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.~Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5."
11349381|NCT04094883|OG000|Outcome|4CMenB Vaccine|"Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.~Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5."
11349382|NCT04094883|EG000|Reported Event|4CMenB Vaccine|"Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.~Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5."
11349383|NCT04091659|BG000|Baseline|Standard Education|"Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education.~Standard Education: Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education."
11349384|NCT04091659|BG001|Baseline|Virtual Reality|"Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention.~Virtual Reality Education: Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention."
11349385|NCT04091659|BG002|Baseline|Total|Total of all reporting groups
11349386|NCT04091659|FG000|Participant Flow|Standard Education|"Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education.~Standard Education: Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education."
11349387|NCT04091659|FG001|Participant Flow|Virtual Reality|"Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention.~Virtual Reality Education: Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention."
11349388|NCT04091659|OG000|Outcome|Standard Education|"Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education.~Standard Education: Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education."
11349389|NCT04091659|OG001|Outcome|Virtual Reality|"Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention.~Virtual Reality Education: Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention."
11349390|NCT04091659|EG000|Reported Event|Standard Education|"Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education.~Standard Education: Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education."
11349391|NCT04091659|EG001|Reported Event|Virtual Reality|"Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention.~Virtual Reality Education: Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention."
11349392|NCT04091061|BG000|Baseline|Cohort 1 (Without Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~NA for participants without hepatic impairment."
11349393|NCT04091061|BG001|Baseline|Cohort 2 (Mild Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class A (5 to 6 points) for participants with mild hepatic impairment."
11349394|NCT04091061|BG002|Baseline|Cohort 3 (Moderate Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class B (7 to 9 points) for participants with moderate hepatic impairment."
11349395|NCT04091061|BG003|Baseline|Cohort 4 (Severe Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class C (10 to 15 points) for participants with severe hepatic impairment."
11349396|NCT04091061|BG004|Baseline|Total|Total of all reporting groups
11349397|NCT04091061|FG000|Participant Flow|Cohort 1 (Without Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~NA for participants without hepatic impairment."
11349398|NCT04091061|FG001|Participant Flow|Cohort 2 (Mild Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class A (5 to 6 points) for participants with mild hepatic impairment."
11349399|NCT04091061|FG002|Participant Flow|Cohort 3 (Moderate Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class B (7 to 9 points) for participants with moderate hepatic impairment."
11349400|NCT04091061|FG003|Participant Flow|Cohort 4 (Severe Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class C (10 to 15 points) for participants with severe hepatic impairment."
11349401|NCT04091061|OG000|Outcome|Cohort 1 (Without Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~NA for participants without hepatic impairment."
11349402|NCT04091061|OG001|Outcome|Cohort 2 (Mild Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class A (5 to 6 points) for participants with mild hepatic impairment."
11349403|NCT04091061|OG002|Outcome|Cohort 3 (Moderate Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class B (7 to 9 points) for participants with moderate hepatic impairment."
11349404|NCT04091061|OG003|Outcome|Cohort 4 (Severe Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class C (10 to 15 points) for participants with severe hepatic impairment."
11349405|NCT04091061|EG000|Reported Event|Cohort 1 (Without Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~NA for participants without hepatic impairment."
11349406|NCT04091061|EG001|Reported Event|Cohort 2 (Mild Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class A (5 to 6 points) for participants with mild hepatic impairment."
11349407|NCT04091061|EG002|Reported Event|Cohort 3 (Moderate Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class B (7 to 9 points) for participants with moderate hepatic impairment."
11349408|NCT04091061|EG003|Reported Event|Cohort 4 (Severe Hepatic Impairment)|"Hepatic function was categorized based on Child Pugh Score.~Class C (10 to 15 points) for participants with severe hepatic impairment."
11349409|NCT04090242|BG000|Baseline|App Plus Nano|"Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin~BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team."
11349410|NCT04090242|BG001|Baseline|Standard Care|Standard of Care/Subject is to continue on their current diabetes management regime
11349411|NCT04090242|BG002|Baseline|Total|Total of all reporting groups
11349412|NCT04090242|FG000|Participant Flow|App Plus Nano|"Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin~BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team."
11349413|NCT04090242|FG001|Participant Flow|Standard Care|Standard of Care/Subject is to continue on their current diabetes management regime
11349414|NCT04090242|OG000|Outcome|App Plus Nano|"Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin~BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team."
11165817|NCT01970540|FG002|Participant Flow|Cohort B: Endometrial|"Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.~lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.~Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate."
11165818|NCT01970540|OG000|Outcome|Patients Without Primary G-CSF Prophylaxis|All participants who received at least one complete cycle study treatments without Primary G-CSF Prophylaxis
11165819|NCT01970540|OG001|Outcome|Patients With Primary G-CSF Prophylaxis|All participants who received at least one complete cycle study treatments with Primary G-CSF Prophylaxis
11165820|NCT01970540|OG000|Outcome|Cohort A: Dose I Without Primary G-CSF Prophylaxis|DOX 50 mg/m2 plus PM01183 3.5 mg FD without primary G-CSF prophylaxis
11165821|NCT01970540|OG001|Outcome|Cohort A: Dose II Without Primary G-CSF Prophylaxis|DOX 50 mg/m2 plus PM01183 3.0 mg FD without primary G-CSF prophylaxis
11165822|NCT01970540|OG002|Outcome|Cohort A: Dose I Without Primary G-CSF Proph and Age Limit|DOX 50 mg/m2 plus PM01183 3.5 mg FD and the Investigators and the Sponsor decided to amend the study's eligibility criteria, which originally did not establish a maximum age limit for the patients, in order to restrict accrual to patients aged between 18 and 75 years, both inclusive
11165823|NCT01970540|OG003|Outcome|Cohort A: Dose III Without Primary G-CSF Prophylaxis|DOX 50 mg/m2 plus PM01183 4.0 mg FD without primary G-CSF prophylaxis
11165824|NCT01970540|OG004|Outcome|Cohort A: Dose IV Without Primary G-CSF Prophylaxis|DOX 50 mg/m2 plus PM01183 5.0 mg FD without primary G-CSF prophylaxis
11165825|NCT01970540|OG005|Outcome|Cohort A: Dose I With Primary G-CSF Prophylaxis|"DOX 50 mg/m2 plus PM01183 3.5 mg FD. Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.~However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis"
11165826|NCT01970540|OG006|Outcome|Cohort A: Dose III With Primary G-CSF Prophylaxis|"DOX 50 mg/m2 plus PM01183 4.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.~However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis"
11165827|NCT01970540|OG007|Outcome|Cohort A: Dose IV With Primary G-CSF Prophylaxis|"DOX 50 mg/m2 plus PM01183 5.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.~However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis"
11165828|NCT01970540|OG008|Outcome|Cohort B: DOX [mg/m2] Plus PM01183 [mg/m2]|DOX [mg/m2] plus PM01183 [mg/m2] Patient accrual into Cohort B started after the RD for the DOX/PM01183 combination had been defined in Cohort A. The dose evaluated in Cohort B was based on this RD, but the DOX dose was decreased to 40 mg/m2 and the PM01183 dose was changed to a BSA-based dose of 2.0 mg/m2 in order to improve the feasibility of this combination in patients with SCLC treated as second-line therapy and in patients with endometrial cancer. In accordance with the findings obtained in Cohort A, no patients in Cohort B received primary G-CSF prophylaxis.
11165829|NCT01970540|OG000|Outcome|Cohort A|"DOX: 50 mg/m² q3wk immediately followed by PM01183. The dose escalation scheme was: 3.0, 3.5, 5.0, 6.0, 7.0 mg FD~lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.~Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate."
11165830|NCT01970540|OG001|Outcome|Cohort B: SCLC 2nd Line|"Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.~lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.~Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate."
11165831|NCT01970540|OG002|Outcome|Cohort B: Endometrial|"Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.~lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.~Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate."
11165832|NCT01970540|EG000|Reported Event|Cohort A|73 patients treated in Cohort A (DOX [mg/m2] plus PM01183 [mg FD]) were evaluable for safety
11165833|NCT01970540|EG001|Reported Event|Cohort B: SCLC 2nd Line|Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
11165834|NCT01970540|EG002|Reported Event|Cohort B: Endometrial|Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
11174060|NCT02019563|OG000|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
11349415|NCT04090242|OG001|Outcome|Standard Care|Standard of Care/Subject is to continue on their current diabetes management regime
11228744|NCT02392611|BG007|Baseline|Combination Therapy: Alobresib 2 mg + Fulvestrant|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
11228745|NCT02392611|BG008|Baseline|Combination Therapy: Alobresib 3 mg + Fulvestrant|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
11228746|NCT02392611|BG009|Baseline|Total|Total of all reporting groups
11228747|NCT02392611|FG000|Participant Flow|Monotherapy: Alobresib 0.6 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through Cycle 1 Day 28 (C1D28) of 28 days cycle to determine the maximum tolerated dose (MTD).
11228748|NCT02392611|FG001|Participant Flow|Monotherapy: Alobresib 1.4 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228749|NCT02392611|FG002|Participant Flow|Monotherapy: Alobresib 2 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228750|NCT02392611|FG003|Participant Flow|Monotherapy: Alobresib 3 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228751|NCT02392611|FG004|Participant Flow|Monotherapy: Alobresib 4 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228752|NCT02392611|FG005|Participant Flow|Monotherapy: Alobresib 6 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228753|NCT02392611|FG006|Participant Flow|Combination Therapy: Alobresib 2 mg + Exemestane|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on Cycle 1 Day 1 (C1D1) of 28 days cycle.
11228754|NCT02392611|FG007|Participant Flow|Combination Therapy: Alobresib 2 mg + Fulvestrant|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
11228755|NCT02392611|FG008|Participant Flow|Combination Therapy: Alobresib 3 mg + Fulvestrant|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
11228756|NCT02392611|OG000|Outcome|Monotherapy: Alobresib 0.6 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228757|NCT02392611|OG001|Outcome|Monotherapy: Alobresib 1.4 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228758|NCT02392611|OG002|Outcome|Monotherapy: Alobresib 2 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228759|NCT02392611|OG003|Outcome|Monotherapy: Alobresib 3 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228760|NCT02392611|OG004|Outcome|Monotherapy: Alobresib 4 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228761|NCT02392611|OG005|Outcome|Monotherapy: Alobresib 6 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228762|NCT02392611|OG006|Outcome|Combination Therapy: Alobresib 2 mg + Exemestane|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.
11228763|NCT02392611|OG007|Outcome|Combination Therapy: Alobresib 2 mg + Fulvestrant|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
11228764|NCT02392611|OG008|Outcome|Combination Therapy: Alobresib 3 mg + Fulvestrant|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
11228765|NCT02392611|EG000|Reported Event|Monotherapy: Alobresib 0.6 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228766|NCT02392611|EG001|Reported Event|Monotherapy: Alobresib 1.4 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228767|NCT02392611|EG002|Reported Event|Monotherapy: Alobresib 2 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228768|NCT02392611|EG003|Reported Event|Monotherapy: Alobresib 3 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228769|NCT02392611|EG004|Reported Event|Monotherapy: Alobresib 4 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228770|NCT02392611|EG005|Reported Event|Monotherapy: Alobresib 6 mg|Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.
11228771|NCT02392611|EG006|Reported Event|Combination Therapy: Alobresib 2 mg + Exemestane|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.
11228772|NCT02392611|EG007|Reported Event|Combination Therapy: Alobresib 2 mg + Fulvestrant|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
11228773|NCT02392611|EG008|Reported Event|Combination Therapy: Alobresib 3 mg + Fulvestrant|Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
11228774|NCT02392624|BG000|Baseline|Omalizumab (Non-Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).
11228775|NCT02392624|BG001|Baseline|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11228776|NCT02392624|BG002|Baseline|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11228777|NCT02392624|BG003|Baseline|Total|Total of all reporting groups
11228778|NCT02392624|FG000|Participant Flow|Omalizumab (Non-Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 milligrams (mg) via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).
11228779|NCT02392624|FG001|Participant Flow|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their chronic idiopathic urticaria (CIU) (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11233906|NCT02431468|EG000|Reported Event|Bryostatin 1 20ug|"Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11228780|NCT02392624|FG002|Participant Flow|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11228781|NCT02392624|OG000|Outcome|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11228782|NCT02392624|OG001|Outcome|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11228783|NCT02392624|OG000|Outcome|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11228784|NCT02392624|EG000|Reported Event|Omalizumab (Non-Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).
11228785|NCT02392624|EG001|Reported Event|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11228786|NCT02392624|EG002|Reported Event|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
11228787|NCT02392767|BG000|Baseline|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
11228788|NCT02392767|BG001|Baseline|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
11228789|NCT02392767|BG002|Baseline|Total|Total of all reporting groups
11228790|NCT02392767|FG000|Participant Flow|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
11228791|NCT02392767|FG001|Participant Flow|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
11228792|NCT02392767|OG000|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
11228793|NCT02392767|OG001|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
11228794|NCT02392767|OG001|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks~Placebo: corn starch"
11228795|NCT02392767|OG001|Outcome|Placebo|2 times 2 tablets a day for 4 weeks. Placebo: corn starch
11228796|NCT02392767|EG000|Reported Event|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
11228797|NCT02392767|EG001|Reported Event|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
11228798|NCT02392806|BG000|Baseline|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
11228799|NCT02392806|BG001|Baseline|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
11228800|NCT02392806|BG002|Baseline|Total|Total of all reporting groups
11165835|NCT01970592|BG000|Baseline|POWER|"Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking.~POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking"
11165836|NCT01970592|FG000|Participant Flow|POWER|"Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking.~POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking"
11165837|NCT01970592|OG000|Outcome|POWER|"Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking.~POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking"
11165838|NCT01970592|EG000|Reported Event|POWER|"Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking.~POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking"
11165839|NCT01970787|BG000|Baseline|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
11165840|NCT01970787|FG000|Participant Flow|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
11165841|NCT01970787|OG000|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
11165842|NCT01970787|EG000|Reported Event|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
11165843|NCT01970878|BG000|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
11165844|NCT01970878|BG001|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg
11165845|NCT01970878|BG002|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
11165846|NCT01970878|BG003|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
11165847|NCT01970878|BG004|Baseline|Total|Total of all reporting groups
11165848|NCT01970878|FG000|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
11165849|NCT01970878|FG001|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg
11165850|NCT01970878|FG002|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
11165851|NCT01970878|FG003|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
11165852|NCT01970878|OG000|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
11165853|NCT01970878|OG001|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
11165854|NCT01970878|OG002|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
11165855|NCT01970878|OG003|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
11165856|NCT01970878|EG000|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
11165857|NCT01970878|EG001|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg
11165858|NCT01970878|EG002|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
11165859|NCT01970878|EG003|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
11165860|NCT01970943|BG000|Baseline|No Intervention|PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition and placebo (saline IV injection)
11165861|NCT01970943|FG000|Participant Flow|No Intervention First, Then Placebo|PET-fMRI investigation on healthy subjects and patients with migraine. No drug conditioning and then placebo saline injection.
11165862|NCT01970943|FG001|Participant Flow|Placebo First, Then No Intervention|PET-fMRI investigation on healthy subjects and patients with migraine. Placebo saline injected followed by no drug conditioning.
11165863|NCT01970943|OG000|Outcome|No Intervention|PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition and placebo saline injection.
11165864|NCT01970943|OG001|Outcome|Placebo|PET-fMRI investigation on healthy subjects and patients with migraine. Placebo saline injection followed by no drug condition.
11165865|NCT01970943|EG000|Reported Event|No Intervention|PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.
11165866|NCT01970943|EG001|Reported Event|Placebo|PET-fMRI investigation on healthy subjects and patients with migraine. Placebo saline injection.
11165867|NCT01970982|BG000|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
11165868|NCT01970982|BG001|Baseline|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
11165869|NCT01970982|BG002|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
11165870|NCT01970982|BG003|Baseline|Total|Total of all reporting groups
11165871|NCT01970982|FG000|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
11165872|NCT01970982|FG001|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
11165873|NCT01970982|FG002|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
11165874|NCT01970982|OG000|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
11165875|NCT01970982|OG001|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11165876|NCT01970982|OG002|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
11165877|NCT01970982|EG000|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
11165878|NCT01970982|EG001|Reported Event|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
11165879|NCT01970982|EG002|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
11165880|NCT01970982|EG003|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
11165881|NCT01970995|BG000|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
11165882|NCT01970995|BG001|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
11165883|NCT01970995|BG002|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
11165884|NCT01970995|BG003|Baseline|Total|Total of all reporting groups
11165885|NCT01970995|FG000|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
11165886|NCT01970995|FG001|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
11165887|NCT01970995|FG002|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
11165888|NCT01970995|OG000|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
11165889|NCT01970995|OG001|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
11165890|NCT01970995|OG002|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
11165891|NCT01970995|EG000|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
11165892|NCT01970995|EG001|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
11165893|NCT01970995|EG002|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
11165894|NCT01971086|BG000|Baseline|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
11165895|NCT01971086|FG000|Participant Flow|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
11165896|NCT01971086|OG000|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
11165897|NCT01971086|OG000|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
11165898|NCT01971086|EG000|Reported Event|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
11174061|NCT02019563|OG001|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
11174062|NCT02019563|OG000|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
11174063|NCT02019563|OG001|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
11228801|NCT02392806|FG000|Participant Flow|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
11228802|NCT02392806|FG001|Participant Flow|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
11228803|NCT02392806|OG000|Outcome|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
11228804|NCT02392806|OG001|Outcome|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
11228805|NCT02392806|EG000|Reported Event|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
11228806|NCT02392806|EG001|Reported Event|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
11228807|NCT02393209|BG000|Baseline|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
11228808|NCT02393209|BG001|Baseline|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
11228809|NCT02393209|BG002|Baseline|Total|Total of all reporting groups
11228810|NCT02393209|FG000|Participant Flow|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
11228811|NCT02393209|FG001|Participant Flow|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
11228812|NCT02393209|FG002|Participant Flow|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
11228813|NCT02393209|FG003|Participant Flow|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
11228814|NCT02393209|OG000|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
11228815|NCT02393209|OG001|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
11228816|NCT02393209|OG000|Outcome|TAK-117 + Docetaxel|TAK-117 200 mg or 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
11228817|NCT02393209|OG000|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
11228818|NCT02393209|OG001|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
11228819|NCT02393209|EG000|Reported Event|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
11228820|NCT02393209|EG001|Reported Event|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
11228821|NCT02393339|BG000|Baseline|Study Group|"Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment~paracetamol: Pre-operative administration of Paracetamol syrup"
11228822|NCT02393339|BG001|Baseline|Controll Group|"Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment.~placebo: Pre-operative administration of placebo syrup"
11228823|NCT02393339|BG002|Baseline|Total|Total of all reporting groups
11228824|NCT02393339|FG000|Participant Flow|Study Group|"Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment~paracetamol: Pre-operative administration of Paracetamol syrup"
11228825|NCT02393339|FG001|Participant Flow|Controll Group|"Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment.~placebo: Pre-operative administration of placebo syrup"
11165899|NCT01971203|BG000|Baseline|Seroquel XR Plus CBT|"Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.~All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time."
11165900|NCT01971203|BG001|Baseline|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
11165901|NCT01971203|BG002|Baseline|Total|Total of all reporting groups
11165902|NCT01971203|FG000|Participant Flow|Seroquel XR Plus CBT|"Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.~All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time."
11165903|NCT01971203|FG001|Participant Flow|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
11165904|NCT01971203|OG000|Outcome|Seroquel XR Plus CBT|Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
11165905|NCT01971203|OG001|Outcome|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
11165906|NCT01971203|EG000|Reported Event|Seroquel XR Plus CBT|Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
11165907|NCT01971203|EG001|Reported Event|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
11165908|NCT01971255|BG000|Baseline|High Titer (HAI > 1:40)|Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 at the time of planned inoculation were placed in this group.
11165909|NCT01971255|BG001|Baseline|Low Titer (HAI < 1:40)|Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 at the time of planned inoculation and were placed in this group.
11165910|NCT01971255|BG002|Baseline|Total|Total of all reporting groups
11165911|NCT01971255|FG000|Participant Flow|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of =1:40 were assigned to this group.
11165912|NCT01971255|FG001|Participant Flow|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of <1:40 were assigned to this group.
11165913|NCT01971255|OG000|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
11165914|NCT01971255|OG001|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
11165915|NCT01971255|EG000|Reported Event|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
11165916|NCT01971255|EG001|Reported Event|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
11165917|NCT01971346|BG000|Baseline|Etanercept|"100 mg Etanercept injections per week for 3 months.~etanercept: 100 mg Etanercept injections per week (2 separate single-use pre-filled 50 mg subcutaneous injections taken on two separate days) for 3 months"
11165918|NCT01971346|FG000|Participant Flow|Etanercept|"100 mg Etanercept injections per week for 3 months.~etanercept: 100 mg Etanercept injections per week (2 separate single-use pre-filled 50 mg subcutaneous injections taken on two separate days) for 3 months"
11165919|NCT01971346|OG000|Outcome|PASI Score at Week 0|PASI will be measured at the baseline visit before treatment.
11165920|NCT01971346|OG001|Outcome|PASI Score at Week 12|PASI will be measured at the Week 12 visit after the course of etanercept treatment.
11165921|NCT01971346|OG000|Outcome|TNF-alpha Signal Strength at Week 0|Strength of TNF-alpha signature measured in skin of study subjects at Week 0.
11165922|NCT01971346|OG001|Outcome|TNF-alpha Signal Strength at Week 6|Strength of TNF-alpha signature measured in skin of study subjects at Week 6.
11165923|NCT01971346|OG002|Outcome|TNF-alpha Signal Strength at Week 12|Strength of TNF-alpha signature measured in skin of study subjects at Week 12.
11165924|NCT01971346|OG000|Outcome|IFN-alpha Signal Strength at Week 0|Strength of IFN-alpha signature measured in blood and skin of study subjects at Week 0.
11165925|NCT01971346|OG001|Outcome|IFN-alpha Signal Strength at Week 6|Strength of IFN-alpha signature measured in blood and skin of study subjects at Week 6.
11165926|NCT01971346|OG002|Outcome|IFN-alpha Signal Strength at Week 12|Strength of IFN-alpha signature measured in blood and skin of study subjects at Week 12.
11165927|NCT01971346|OG000|Outcome|Etanercept|Patients who received 100 mg Etanercept injections per week for 3 months with recorded PASI score at Week 0 and Week 12 visits.
11165928|NCT01971346|EG000|Reported Event|Etanercept|"100 mg Etanercept injections per week for 3 months.~etanercept: 100 mg Etanercept injections per week (2 separate single-use pre-filled 50 mg subcutaneous injections taken on two separate days) for 3 months"
11165929|NCT01971385|BG000|Baseline|0.2% Squaric Acid|"0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
11165930|NCT01971385|BG001|Baseline|0.5% Squaric Acid|"0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
11165931|NCT01971385|BG002|Baseline|Placebo Solution|"Patients in placebo group will be given dimethyl sulfoxide.~Placebo solution"
11165932|NCT01971385|BG003|Baseline|Total|Total of all reporting groups
11165933|NCT01971385|FG000|Participant Flow|0.2% Squaric Acid|"0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
11165934|NCT01971385|FG001|Participant Flow|0.5% Squaric Acid|"0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
11165935|NCT01971385|FG002|Participant Flow|Placebo Solution|"Patients in placebo group will be given dimethyl sulfoxide.~Placebo solution"
11349416|NCT04090242|OG000|Outcome|App Plus Nano|Use of BD Diabetes care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin.
11349417|NCT04090242|EG000|Reported Event|App Plus Nano|"Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin~BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team."
11349418|NCT04090242|EG001|Reported Event|Standard Care|Standard of Care/Subject is to continue on their current diabetes management regime
11349419|NCT04089761|BG000|Baseline|Active Device|"Treatment of acute migraine with an active form of Nerivio device~Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
11349420|NCT04089761|FG000|Participant Flow|Active Device|"Treatment of acute migraine with an active form of Nerivio device~Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
11349421|NCT04089761|OG000|Outcome|Active Device|"Treatment of acute migraine with an active form of Nerivio device~Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
11349422|NCT04089761|EG000|Reported Event|Active Device|"Treatment of acute migraine with an active form of Nerivio device~Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application."
11349423|NCT04079803|BG000|Baseline|Placebo Cohort|Subjects administered matching placebo tablets twice daily for 28 days.
11349424|NCT04079803|BG001|Baseline|Simufilam (PTI-125), 100 mg Tablets Cohort|Subjects administered 100 mg simufilam tablets twice daily for 28 days.
11349425|NCT04079803|BG002|Baseline|Simufilam (PTI-125), 50 mg Tablets Cohort|Subjects administered 50 mg simufilam tablets twice daily for 28 days.
11165936|NCT01971385|OG000|Outcome|2% Squaric Acid Sensitization|"2% Squaric Acid solution will be applied for sensitization to the inner arm.~Squaric Acid solution"
11165937|NCT01971385|OG001|Outcome|Placebo Solution|"Patients in placebo group will be given dimethyl sulfoxide.~Placebo solution"
11349426|NCT04079803|BG003|Baseline|Total|Total of all reporting groups
11349427|NCT04079803|FG000|Participant Flow|Placebo Cohort|Subjects administered placebo oral tablets twice daily (BID)
11349428|NCT04079803|FG001|Participant Flow|Simufilam (PTI-125), 100 mg Tablets Cohort|Subjects administered simufilam 100 mg oral tablets twice daily (BID)
11349429|NCT04079803|FG002|Participant Flow|Simufilam (PTI-125), 50 mg Tablets Cohort|Subjects administered simufilam 50 mg oral tablets twice daily (BID)
11349430|NCT04079803|OG000|Outcome|Placebo Cohort|Placebo tablets BID for 28 days
11349431|NCT04079803|OG001|Outcome|Simufilam (PTI-125), 100 mg Tablets Cohort|simufilam 100 mg tablets BID for 28 days
11349432|NCT04079803|OG002|Outcome|Simufilam (PTI-125), 50 mg Tablets Cohort|simufilam 50 mg tablets BID for 28 days
11349433|NCT04079803|OG000|Outcome|Placebo Cohort|Placebo oral tablets administered twice daily (BID)
11349434|NCT04079803|OG001|Outcome|Simufilam (PTI-125) 100 mg Tablets Cohort|Simufilam (PTI-125) 100 mg oral tablets administered twice daily (BID)
11349435|NCT04079803|OG002|Outcome|Simufilam (PTI-125) 50 mg Tablets Cohort|SImufilam (PTI-125) 50 mg oral tablets administered twice daily (BID)
11349436|NCT04079803|OG000|Outcome|Placebo Cohort|Placebo oral tablets administered twice daily (BID) for 28 days.
11349437|NCT04079803|OG001|Outcome|Simufilam (PTI-125), 100 mg Tablets Cohort|Simufilam 100 mg oral tablets administered twice daily (BID) for 28 days.
11349438|NCT04079803|OG002|Outcome|Simufilam (PTI-125), 50 mg Tablets Cohort|Simufilam 50 mg oral tablets administered twice daily (BID) for 28 days.
11349439|NCT04079803|OG001|Outcome|Simufilam (PTI-125), 100 mg Tablets Cohort|Simufilam, 100 mg oral tablets administered twice daily (BID)
11349440|NCT04079803|OG002|Outcome|Simufilam (PTI-125), 50 mg Tablets Cohort|Simufilam, 50 mg oral tablets administered twice daily (BID)
11349441|NCT04079803|OG000|Outcome|Placebo Cohort|"Subjects administered placebo oral tablets twice daily (BID)~Placebo oral tablet: Oral placebo tablet"
11349442|NCT04079803|OG001|Outcome|Simufilam (PTI-125) 100 mg Tablets Cohort|"Subjects administered simufilam (PTI-125) 100 mg oral tablets twice daily (BID)~Simufilam 50 mg oral tablet: Simufilam 50 mg oral tablet"
11349443|NCT04079803|OG002|Outcome|Simufilam (PTI-125) 50 mg Tablets Cohort|"Subjects administered simufilam (PTI-125) 50 mg oral tablets twice daily (BID)~Simufilam 100 mg tablet: Simufilam 100 mg oral tablet"
11349444|NCT04079803|OG000|Outcome|Placebo Cohort|Subjects administered placebo oral tablets twice daily (BID)
11349445|NCT04079803|OG001|Outcome|Simufilam (PTI-125), 100 mg Tablets Cohort|Subjects administered simufilam 100 mg oral tablets twice daily (BID)
11349446|NCT04079803|OG002|Outcome|Simufilam (PTI-125), 50 mg Tablets Cohort|Subjects administered simufilam 50 mg oral tablets twice daily (BID)
11349447|NCT04079803|EG000|Reported Event|Placebo Cohort|Subjects administered placebo tablets twice daily (BID) for 28 days.
11349448|NCT04079803|EG001|Reported Event|Simufilam (PTI-125), 100 mg Tablets Cohort|Subjects administered simufilam 100 mg tablets twice daily (BID) for 28 days.
11349449|NCT04079803|EG002|Reported Event|Simufilam (PTI-125), 50 mg Tablets Cohort|Subjects administered simufilam 50 mg tablets twice daily (BID) for 28 days.
11349450|NCT04086576|BG000|Baseline|Commercial Smartphone-paired Breathalyzers-Set 1|Smartphone-paired mobile breathalyzer-Set 1: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
11349451|NCT04086576|BG001|Baseline|Commercial Smartphone-paired Breathalyzers-Set 2|Smartphone-paired mobile breathalyzer-Set 2: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
11349452|NCT04086576|BG002|Baseline|Total|Total of all reporting groups
11349453|NCT04086576|FG000|Participant Flow|Commercial Smartphone-paired Breathalyzers-Set 1|Smartphone-paired mobile breathalyzer-Set 1: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
11349454|NCT04086576|FG001|Participant Flow|Commercial Smartphone-paired Breathalyzers-Set 2|Smartphone-paired mobile breathalyzer-Set 2: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
11349455|NCT04086576|OG000|Outcome|Alcohoot|Alcohoot branded smartphone-paired breathalyzer
11349456|NCT04086576|OG001|Outcome|BACtrack Mobile Pro|BACtrack Mobile Pro branded smartphone-paired breathalyzer
11349457|NCT04086576|OG002|Outcome|DRIVESAFE Evoc|DRIVESAFE Evoc branded smartphone-paired breathalyzer
11349458|NCT04086576|OG003|Outcome|Intoxilyzer 240 (A)|Intoxilyzer 240 police grade breathalyzer
11349459|NCT04086576|OG004|Outcome|BACtrack Vio|BACtrack Vio branded smartphone-paired breathalyzer
11349460|NCT04086576|OG005|Outcome|Drinkmate|Drinkmate branded smartphone-paired breathlyzer
11165938|NCT01971385|EG000|Reported Event|0.2% Squaric Acid|"0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
11165939|NCT01971385|EG001|Reported Event|0.5% Squaric Acid|"0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
11165940|NCT01971385|EG002|Reported Event|Placebo Solution|"Patients in placebo group will be given dimethyl sulfoxide.~Placebo solution"
11165941|NCT01971463|BG000|Baseline|Normal Saline|"intravenous administration of 500cc of 0.9% NaCl over 30 minutes~Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes"
11349461|NCT04086576|OG006|Outcome|Floome|Floome branded smartphone-paired breathalyzer
11349462|NCT04086576|OG007|Outcome|Intoxilyzer 240 (B)|Intoxilyzer 240 police grade breathalyzer
11349463|NCT04086576|OG008|Outcome|Percent of Alcohol in Blood|Percentage of Alcohol in Blood measured from blood draw
11349464|NCT04086576|OG003|Outcome|BACtrack Vio|BACtrack Vio branded smartphone-paired breathalyzer
11349465|NCT04086576|OG004|Outcome|Drinkmate|Drinkmate branded smartphone-paired breathlyzer
11349466|NCT04086576|OG005|Outcome|Floome|Floome branded smartphone-paired breathalyzer
11349467|NCT04086576|EG000|Reported Event|Commercial Smartphone-paired Breathalyzers-Set 1|"All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.~Alcohoot: Alcohoot branded smartphone-paired breathalyzer~BACtrack Mobile Pro: BACtrack Mobile Pro branded smartphone-paired breathalyzer~DRIVESAFE Evoc: DRIVESAFE Evoc branded smartphone-paired breathalyzer~Intoxilyzer 240: Intoxilyzer 240 police grade breathalyzer"
11349468|NCT04086576|EG001|Reported Event|Commercial Smartphone-paired Breathalyzers-Set 2|"All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.~BACtrack Vio: BACtrack Vio branded smartphone-paired breathalyzer~Drinkmate: Drinkmate branded smartphone-paired breathalyzer~Floome: Floome branded smartphone-paired breathalyzer~Intoxilyzer 240: Intoxilyzer 240 police grade breathalyzer"
11228826|NCT02393339|OG000|Outcome|Study Group|"Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment~paracetamol: Pre-operative administration of Paracetamol syrup"
11228827|NCT02393339|OG001|Outcome|Controll Group|"Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment.~placebo: Pre-operative administration of placebo syrup"
11228828|NCT02393339|EG000|Reported Event|Study Group|"Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment~paracetamol: Pre-operative administration of Paracetamol syrup"
11228829|NCT02393339|EG001|Reported Event|Controll Group|"Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment.~placebo: Pre-operative administration of placebo syrup"
11228830|NCT02393378|BG000|Baseline|Adalimumab 40 mg|Adalimumab 40 mg SC injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 as an add-on to weekly existing stable MTX and folic acid as prescribed in clinical practice.
11228831|NCT02393378|BG001|Baseline|Namilumab 150 mg|Namilumab 300 mg SC injection at Week 0 followed by 150 mg SC injection at Weeks 2, 6, 10, 14, 18, and 22 as an add-on to weekly existing stable MTX and folic acid as prescribed in clinical practice.
11228832|NCT02393378|BG002|Baseline|Total|Total of all reporting groups
11228833|NCT02393378|FG000|Participant Flow|Adalimumab 40 mg|Adalimumab 40 mg SC injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 as an add-on to weekly existing stable MTX and folic acid as prescribed in clinical practice.
11228834|NCT02393378|FG001|Participant Flow|Namilumab 150 mg|Namilumab 300 mg SC injection at Week 0 followed by 150 mg SC injection at Weeks 2, 6, 10, 14, 18, and 22 as an add-on to weekly existing stable MTX and folic acid as prescribed in clinical practice.
11228835|NCT02393378|OG000|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 as an add-on to weekly existing stable MTX and folic acid as prescribed in clinical practice.
11228836|NCT02393378|OG001|Outcome|Namilumab 150 mg|Namilumab 300 mg SC injection at Week 0 followed by 150 mg SC injection at Weeks 2, 6, 10, 14, 18, and 22 as an add-on to weekly existing stable MTX and folic acid as prescribed in clinical practice.
11228837|NCT02393378|EG000|Reported Event|Adalimumab 40 mg|Adalimumab 40 mg SC injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 as an add-on to weekly existing stable MTX and folic acid as prescribed in clinical practice.
11228838|NCT02393378|EG001|Reported Event|Namilumab 150 mg|Namilumab 300 mg SC injection at Week 0 followed by 150 mg SC injection at Weeks 2, 6, 10, 14, 18, and 22 as an add-on to weekly existing stable MTX and folic acid as prescribed in clinical practice.
11228839|NCT02393417|BG000|Baseline|Pooled Placebo|"0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)~Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)"
11228840|NCT02393417|BG001|Baseline|Cohort 1|"0.3 mL of CANDIN administered intralesionally in the largest common wart~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228841|NCT02393417|BG002|Baseline|Cohort 2|"0.5 mL of CANDIN administered intralesionally in the largest common wart~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228842|NCT02393417|BG003|Baseline|Cohort 3|"0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228843|NCT02393417|BG004|Baseline|Total|Total of all reporting groups
11228844|NCT02393417|FG000|Participant Flow|Pooled Placebo|"0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)~Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)"
11228845|NCT02393417|FG001|Participant Flow|Cohort 1|"0.3 mL of CANDIN administered intralesionally in the largest common wart~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228846|NCT02393417|FG002|Participant Flow|Cohort 2|"0.5 mL of CANDIN administered intralesionally in the largest common wart~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228847|NCT02393417|FG003|Participant Flow|Cohort 3|"0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228848|NCT02393417|OG000|Outcome|Pooled Placebo|"0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)~Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)"
11228849|NCT02393417|OG001|Outcome|Cohort 1|"0.3 mL of CANDIN administered intralesionally in the largest common wart~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228850|NCT02393417|OG002|Outcome|Cohort 2|"0.5 mL of CANDIN administered intralesionally in the largest common wart~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228851|NCT02393417|OG003|Outcome|Cohort 3|"0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228852|NCT02393417|OG001|Outcome|Cohort 1 and Cohort 3|"0.3 mL of CANDIN administered intralesionally in the largest common wart (Cohort 1) and multiple common warts (Cohort 3)~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228853|NCT02393417|EG000|Reported Event|Pooled Placebo|"0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)~Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)"
11228854|NCT02393417|EG001|Reported Event|Cohort 1|"0.3 mL of CANDIN administered intralesionally in the largest common wart~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228855|NCT02393417|EG002|Reported Event|Cohort 2|"0.5 mL of CANDIN administered intralesionally in the largest common wart~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11228856|NCT02393417|EG003|Reported Event|Cohort 3|"0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)~CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity"
11349469|NCT04086641|BG000|Baseline|Foot 1: Crossover Foot, Foot 2: Energy Storing Foot|Participants first received a crossover foot, then switched to an energy storing foot
11349470|NCT04086641|BG001|Baseline|Foot 1: Energy Storing Foot, Foot 2: Crossover Foot|Participants first received an energy storing foot, then switched to a crossover foot
11349471|NCT04086641|BG002|Baseline|Total|Total of all reporting groups
11349472|NCT04086641|FG000|Participant Flow|Foot 1: Crossover Foot, Foot 2: Energy Storing Foot|Participants first received a crossover foot, then switched to an energy storing foot. Each foot was utilized for a two week accommodation period at minimum prior to data collection & subsequent switch.
11349473|NCT04086641|FG001|Participant Flow|Foot 1: Energy Storing Foot, Foot 2: Crossover Foot|Participants first received an energy storing foot, then switched to a crossover foot. Each foot was utilized for a two week accommodation period at minimum prior to data collection & subsequent switch.
11349474|NCT04086641|OG000|Outcome|Foot 1: Crossover Foot, Foot 2: Energy Storing Foot|First intervention was crossover foot, second was energy storing foot
11349475|NCT04086641|OG001|Outcome|Foot 1: Energy Storing Foot, Foot 2: Crossover Foot|First intervention was energy storing foot, second was crossover foot
11349476|NCT04086641|EG000|Reported Event|Foot 1: Crossover Foot, Foot 2: Energy Storing Foot|Participants first received the crossover foot, then switched to the energy storing
11349477|NCT04086641|EG001|Reported Event|Foot 1: Energy Storing Foot, Foot 2: Crossover Foot|Participants first received the energy storing foot, then switched to the crossover foot
11349478|NCT04080882|BG000|Baseline|Placebo|"placebo injected into platysma bands~Placebo: Treatment of platysmal bands"
11349479|NCT04080882|BG001|Baseline|AbobotulinumtoxinA Dose 1|"AbobotulinumtoxinA dose 1 injected into platysma bands~AbobotulinumtoxinA dose 1: Treatment of platysmal bands"
11349480|NCT04080882|BG002|Baseline|Total|Total of all reporting groups
11349481|NCT04080882|FG000|Participant Flow|Placebo|"placebo injected into platysma bands~Placebo: Treatment of platysmal bands"
11349482|NCT04080882|FG001|Participant Flow|AbobotulinumtoxinA Dose 1|"AbobotulinumtoxinA dose 1 injected into platysma bands~AbobotulinumtoxinA dose 1: Treatment of platysmal bands"
11349483|NCT04080882|OG000|Outcome|Placebo|"placebo injected into platysma bands~Placebo: Treatment of platysmal bands"
11349484|NCT04080882|OG001|Outcome|AbobotulinumtoxinA Dose 1|"AbobotulinumtoxinA dose 1 injected into platysma bands~AbobotulinumtoxinA dose 1: Treatment of platysmal bands"
11349485|NCT04080882|EG000|Reported Event|Placebo|"placebo injected into platysma bands~Placebo: Treatment of platysmal bands"
11349486|NCT04080882|EG001|Reported Event|AbobotulinumtoxinA Dose 1|"AbobotulinumtoxinA dose 1 injected into platysma bands~AbobotulinumtoxinA dose 1: Treatment of platysmal bands"
11349487|NCT04085289|BG000|Baseline|Placebo|Participants received a single Subcutaneous (SC) dose of Placebo.
11349488|NCT04085289|BG001|Baseline|120 mg Galcanezumab SC|Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
11349489|NCT04085289|BG002|Baseline|240 mg Galcanezumab SC|Participants received a single SC dose of 240 mg Galcanezumab.
11349490|NCT04085289|BG003|Baseline|Total|Total of all reporting groups
11349491|NCT04085289|FG000|Participant Flow|Placebo|Participants received a single Subcutaneous (SC) dose of Placebo.
11349492|NCT04085289|FG001|Participant Flow|120 mg Galcanezumab SC|Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
11349493|NCT04085289|FG002|Participant Flow|240 mg Galcanezumab SC|Participants received a single SC dose of 240 mg Galcanezumab.
11349494|NCT04085289|OG000|Outcome|120 mg Galcanezumab SC|Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
11349495|NCT04085289|OG001|Outcome|240 mg Galcanezumab SC|Participants received a single SC dose of 240 mg Galcanezumab.
11349496|NCT04085289|EG000|Reported Event|Placebo|Participants received a single Subcutaneous (SC) dose of Placebo.
11349497|NCT04085289|EG001|Reported Event|120 mg Galcanezumab SC|Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
11349498|NCT04085289|EG002|Reported Event|240 mg Galcanezumab SC|Participants received a single SC dose of 240 mg Galcanezumab.
11349499|NCT04084015|BG000|Baseline|Early Axillary Impella®|"Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO~Axillary Impella®: All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy"
11349500|NCT04084015|FG000|Participant Flow|Early Axillary Impella®|"Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO~Axillary Impella®: All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy"
11165942|NCT01971463|FG000|Participant Flow|Normal Saline|"intravenous administration of 500cc of 0.9% NaCl over 30 minutes~Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes"
11349501|NCT04084015|OG000|Outcome|Early Axillary Impella®|"Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO~Axillary Impella®: All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy"
11349502|NCT04084015|EG000|Reported Event|Early Axillary Impella®|"Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO~Axillary Impella®: All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy"
11349503|NCT04082663|BG000|Baseline|Dental Mouthpiece|"Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans.~Dental Mouthpiece: Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece."
11165943|NCT01971463|OG000|Outcome|Normal Saline|"intravenous administration of 500cc of 0.9% NaCl over 30 minutes~Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes"
11165944|NCT01971463|EG000|Reported Event|Normal Saline|"intravenous administration of 500cc of 0.9% NaCl over 30 minutes~Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes"
11165945|NCT01971476|BG000|Baseline|Volasertib 200 mg/m2|The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165946|NCT01971476|BG001|Baseline|Volasertib 250 mg/m2|The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165947|NCT01971476|BG002|Baseline|Volasertib 300 mg/m2|The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165948|NCT01971476|BG003|Baseline|Total|Total of all reporting groups
11165949|NCT01971476|FG000|Participant Flow|Volasertib 200 mg/m2|The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour (h) on Day 1 of 14-day cycle.
11165950|NCT01971476|FG001|Participant Flow|Volasertib 250 mg/m2|The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165951|NCT01971476|FG002|Participant Flow|Volasertib 300 mg/m2|The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165952|NCT01971476|OG000|Outcome|2 to <12 Years: Volasertib 200 mg/m2|The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165953|NCT01971476|OG001|Outcome|2 to <12 Years: Volasertib 250 mg/m2|The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165954|NCT01971476|OG002|Outcome|2 to <12 Years: Volasertib 300 mg/m2|The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165955|NCT01971476|OG003|Outcome|12 to <18 Years: Volasertib 200 mg/m2|The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165956|NCT01971476|OG004|Outcome|12 to <18 Years: Volasertib 250 mg/m2|The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165957|NCT01971476|OG005|Outcome|12 to <18 Years: Volasertib 300 mg/m2|The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165958|NCT01971476|OG000|Outcome|12 to <18 Years: Volasertib 300 mg/m2|The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165959|NCT01971476|OG001|Outcome|12 to <18 Years: Volasertib 200 mg/m2|The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165960|NCT01971476|EG000|Reported Event|2 to <12 Years: Volasertib 200 mg/m2|The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165961|NCT01971476|EG001|Reported Event|2 to <12 Years: Volasertib 250 mg/m2|The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165962|NCT01971476|EG002|Reported Event|2 to <12 Years: Volasertib 300 mg/m2|The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165963|NCT01971476|EG003|Reported Event|2 to <12 Years: Volasertib Pooled Total|The pooled total of patients administered Volasertib 200 mg/m2/250 mg/m2/300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165964|NCT01971476|EG004|Reported Event|12 to <18 Years: Volasertib 200 mg/m2|The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165965|NCT01971476|EG005|Reported Event|12 to <18 Years: Volasertib 250 mg/m2|The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 1-day cycle.
11165966|NCT01971476|EG006|Reported Event|12 to <18 Years: Volasertib Pooled Total|The pooled total of patients administered Volasertib 200 mg/m2/250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
11165967|NCT01971554|BG000|Baseline|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
11165968|NCT01971554|BG001|Baseline|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
11165969|NCT01971554|BG002|Baseline|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
11165970|NCT01971554|BG003|Baseline|Placebo|Placebo once daily for 14 consecutive days
11165971|NCT01971554|BG004|Baseline|Total|Total of all reporting groups
11165972|NCT01971554|FG000|Participant Flow|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
11165973|NCT01971554|FG001|Participant Flow|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
11165974|NCT01971554|FG002|Participant Flow|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
11165975|NCT01971554|FG003|Participant Flow|Placebo|Placebo once daily for 14 consecutive days
11165976|NCT01971554|OG000|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
11165977|NCT01971554|OG001|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
11165978|NCT01971554|OG002|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
11165979|NCT01971554|OG003|Outcome|Placebo|Placebo once daily for 14 consecutive days
11165980|NCT01971554|EG000|Reported Event|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
11165981|NCT01971554|EG001|Reported Event|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
11165982|NCT01971554|EG002|Reported Event|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
11165983|NCT01971554|EG003|Reported Event|Placebo|Placebo once daily for 14 consecutive days
11165984|NCT01971567|BG000|Baseline|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
11165985|NCT01971567|BG001|Baseline|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
11165986|NCT01971567|BG002|Baseline|Total|Total of all reporting groups
11165987|NCT01971567|FG000|Participant Flow|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
11165988|NCT01971567|FG001|Participant Flow|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
11165989|NCT01971567|OG000|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
11165990|NCT01971567|OG001|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
11165991|NCT01971567|EG000|Reported Event|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
11165992|NCT01971567|EG001|Reported Event|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
11165993|NCT01971580|BG000|Baseline|Ambrisentan First, Placebo Second|"These patients will be randomized to have ambrisentan during the first study period, and placebo during the second study period.~Ambrisentan"
11165994|NCT01971580|BG001|Baseline|Placebo First, Ambrisentan Second|"These patients will be randomized to have placebo during the first study period, and ambrisentan during the second study period.~Ambrisentan"
11165995|NCT01971580|BG002|Baseline|Total|Total of all reporting groups
11165996|NCT01971580|FG000|Participant Flow|Ambrisentan First, Placebo Second|"These patients will be randomized to have ambrisentan during the first study period, and placebo during the second study period.~Ambrisentan"
11165997|NCT01971580|FG001|Participant Flow|Placebo First, Ambrisentan Second|"These patients will be randomized to have placebo during the first study period, and ambrisentan during the second study period.~Ambrisentan"
11165998|NCT01971580|OG000|Outcome|On Ambrisentan Therapy|After Ambrisentan compared to baseline
11165999|NCT01971580|OG001|Outcome|On Placebo|After Placebo compared to baseline
11166000|NCT01971580|OG000|Outcome|On Ambrisentan Therapy|Baseline compared to after period of ambrisentan therapy
11166001|NCT01971580|OG001|Outcome|On Placebo|Baseline compared to after placebo therapy
11166002|NCT01971580|EG000|Reported Event|On Ambrisentan Therapy|Events that occurred while on ambrisentan therapy
11166003|NCT01971580|EG001|Reported Event|On Placebo|Events that occurred while on placebo therapy
11166004|NCT01971593|BG000|Baseline|Total Study Group|Crossover study, all patients pooled for baseline analysis
11166005|NCT01971593|FG000|Participant Flow|Eplerenone After Drug Free Period|"Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period~Eplerenone"
11166006|NCT01971593|FG001|Participant Flow|Eplerenone Before Drug Free Period|"Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period~Eplerenone"
11166007|NCT01971593|OG000|Outcome|Total Study Group|Change from baseline at time of drug initiation
11166008|NCT01971593|EG000|Reported Event|Eplerenone Period|Change from baseline at time of drug initiation
11166009|NCT01971645|BG000|Baseline|Perineural Dexamethasone Group|"Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166010|NCT01971645|BG001|Baseline|Ropivacaine Group|"Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166011|NCT01971645|BG002|Baseline|Intramuscular Dexamethasone Group|"Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166012|NCT01971645|BG003|Baseline|Total|Total of all reporting groups
11166013|NCT01971645|FG000|Participant Flow|Perineural Dexamethasone Group|"Perineural group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166014|NCT01971645|FG001|Participant Flow|Ropivacaine Group|"Ropivacaine group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166015|NCT01971645|FG002|Participant Flow|Intramuscular Dexamethasone Group|"Intramuscular group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166016|NCT01971645|OG000|Outcome|Group D|"Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166017|NCT01971645|OG001|Outcome|Group R|"Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166018|NCT01971645|OG002|Outcome|Group M|"Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166019|NCT01971645|EG000|Reported Event|Group D|"Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166020|NCT01971645|EG001|Reported Event|Group R|"Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166021|NCT01971645|EG002|Reported Event|Group M|"Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
11166022|NCT01971723|BG000|Baseline|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
11166023|NCT01971723|BG001|Baseline|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
11166024|NCT01971723|BG002|Baseline|Total|Total of all reporting groups
11166025|NCT01971723|FG000|Participant Flow|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
11228857|NCT02393547|BG000|Baseline|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
11349504|NCT04082663|FG000|Participant Flow|Dental Mouthpiece|"Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans.~Dental Mouthpiece: Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece."
11349505|NCT04082663|OG000|Outcome|Dental Mouthpiece|"Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans.~Dental Mouthpiece: Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece."
11349506|NCT04082663|EG000|Reported Event|Dental Mouthpiece|"Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans.~Dental Mouthpiece: Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece."
11349507|NCT04084028|BG000|Baseline|Active Cooking +Meal Kits and Recipes|"Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal.~Following 6 weeks of cooking classes, participants will receive 6 weeks of home-delivered meal kits. Following 6 weeks of meal kits, participants will received 6 weeks of recipes. Both the meal kits and recipes will accommodate major dietary needs (vegan, gluten-free, etc.)"
11349508|NCT04084028|BG001|Baseline|Active Cooking Only|Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal. Unlike the previous arm, no further instruction will be given once cooking classes end.
11349509|NCT04084028|BG002|Baseline|Meal Kits Only|Participants will receive weekly meal kit deliveries for 6 weeks. Following 6 weeks of meal kit deliveries, students will receive emails at the beginning of each week providing them with 5 healthy recipes.
11349510|NCT04084028|BG003|Baseline|Control|Participants will receive no interventions.
11349511|NCT04084028|BG004|Baseline|Total|Total of all reporting groups
11349512|NCT04084028|FG000|Participant Flow|Active Cooking +Meal Kits and Recipes|"Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal.~Following 6 weeks of cooking classes, participants will receive 6 weeks of home-delivered meal kits. Following 6 weeks of meal kits, participants will received 6 weeks of recipes. Both the meal kits and recipes will accommodate major dietary needs (vegan, gluten-free, etc.)~Active Cooking + Meal Kits + Recipes: 6 cooking classes will be held every week for 6 consecutive weeks. The lessons are patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for those cooking for themselves for the first time. Classes begin with a brief lecture on the day's topic. Students will work in teams of 2 in the foods lab to actively practice skills and cook a meal. Students receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. All students attend a 2 hour kitchen intensive demonstration as an orientation. After 6 weeks students receive 6 weeks of meal kits followed by 6 weeks of recipes."
11349513|NCT04084028|FG001|Participant Flow|Active Cooking Only|"Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal. Unlike the previous arm, no further instruction will be given once cooking classes end.~Active cooking: Students receive the same cooking intervention and kitchen intensive orientation as described in the Active cooking + meal kits + recipes. However, once the 6 weeks of the cooking class have ended, there is no further intervention."
11349514|NCT04084028|FG002|Participant Flow|Meal Kits and Recipes Only|Participants will receive weekly meal kit deliveries for 6 weeks.
11349515|NCT04084028|FG003|Participant Flow|Control|Participants will receive no interventions.
11166026|NCT01971723|FG001|Participant Flow|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
11349516|NCT04084028|OG000|Outcome|Active Cooking +Meal Kits and Recipes|"Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal.~Following 6 weeks of cooking classes, participants will receive 6 weeks of home-delivered meal kits."
11349517|NCT04084028|OG001|Outcome|Active Cooking Only|"Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal. Unlike the previous arm, no further instruction will be given once cooking classes end.~Active Cooking Classes: 6 cooking classes will be held every week for 6 consecutive weeks. The lessons are patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for those cooking for themselves for the first time. Classes begin with a brief lecture on the day's topic. Students will work in teams of 2 in the foods lab to actively practice skills and cook a meal. Students receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. All students attend a 2 hour kitchen intensive demonstration as an orientation."
11349518|NCT04084028|OG002|Outcome|Meal Kits Only|Participants will receive weekly meal kit deliveries for 6 weeks.
11349519|NCT04084028|OG003|Outcome|Control|Participants will receive no interventions.
11349520|NCT04084028|OG001|Outcome|Active Cooking Only|"Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal. Unlike the previous arm, no further instruction will be given once cooking classes end.~."
11349521|NCT04084028|OG002|Outcome|Meal Kits Only|"Participants will receive weekly meal kit deliveries for 6 weeks.~Meal Kits: Students receive 6 weeks of home delivered meal kits. Meal kits include ingredients and detailed instructions for 3 meals, which each serve two people. Students may select meals from a list of 18 options that include vegan, vegetarian, and gluten free options."
11349522|NCT04084028|EG000|Reported Event|Active Cooking +Meal Kits and Recipes|"Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal.~Following 6 weeks of cooking classes, participants will receive 6 weeks of home-delivered meal kits."
11349523|NCT04084028|EG001|Reported Event|Active Cooking Only|"Participants will attend a weekly 2-hour cooking class to learn how to prepare meals. Participants cook and sample the meal at the end of class and the chef will walk them through a sensory exercise. At the end of each class, participants will be provided with the recipe for the next class and asked to create a timeline for the various steps of preparation. Participants will bring this timeline to class and discuss as a group before preparing the meal. Unlike the previous arm, no further instruction will be given once cooking classes end.~."
11349524|NCT04084028|EG002|Reported Event|Meal Kits Only|"Participants will receive weekly meal kit deliveries for 6 weeks.~Meal Kits: Students receive 6 weeks of home delivered meal kits. Meal kits include ingredients and detailed instructions for 3 meals, which each serve two people. Students may select meals from a list of 18 options that include vegan, vegetarian, and gluten free options."
11349525|NCT04084028|EG003|Reported Event|Control|Participants will receive no interventions.
11349526|NCT04082819|BG000|Baseline|Low Blood Pressure|"Low blood pressure (systolic: 0-129, diastolic: 0-79)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349527|NCT04082819|BG001|Baseline|Medium Blood Pressure|"Medium blood pressure (systolic: 130-160, diastolic: 80-100)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349528|NCT04082819|BG002|Baseline|High Blood Pressure|"High blood pressure (systolic: 161 or higher, diastolic: 101 or higher)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349529|NCT04082819|BG003|Baseline|Total|Total of all reporting groups
11349530|NCT04082819|FG000|Participant Flow|Low Blood Pressure|"Low blood pressure (systolic: 0-129, diastolic: 0-79)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349531|NCT04082819|FG001|Participant Flow|Medium Blood Pressure|"Medium blood pressure (systolic: 130-160, diastolic: 80-100)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349532|NCT04082819|FG002|Participant Flow|High Blood Pressure|"High blood pressure (systolic: 161 or higher, diastolic: 101 or higher)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349533|NCT04082819|OG000|Outcome|Low Blood Pressure|Systolic score between 90 - 120mmHg.
10887783|NCT00502697|OG001|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
11166027|NCT01971723|OG000|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
11166028|NCT01971723|OG001|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
11166029|NCT01971723|EG000|Reported Event|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
11166030|NCT01971723|EG001|Reported Event|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
11166031|NCT01972061|BG000|Baseline|CMG Group|"Foot stimulation will be applied during a cystometrogram (CMG).~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166032|NCT01972061|BG001|Baseline|3 Hours Group|"Foot stimulation will be applied daily for 3 hours in the evening.~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166033|NCT01972061|BG002|Baseline|1/2 Hour Group|"Foot stimulation will be applied daily for 1/2 hour in the evening.~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166034|NCT01972061|BG003|Baseline|Total|Total of all reporting groups
11166035|NCT01972061|FG000|Participant Flow|CMG Group|"Foot stimulation will be applied during a cystometrogram (CMG).~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166036|NCT01972061|FG001|Participant Flow|3 Hours Group|"Foot stimulation will be applied daily for 3 hours in the evening.~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166037|NCT01972061|FG002|Participant Flow|1/2 Hour Group|"Foot stimulation will be applied daily for 1/2 hour in the evening.~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166038|NCT01972061|OG000|Outcome|3 Hours Group|"Foot stimulation will be applied daily for 3 hours in the evening.~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166039|NCT01972061|OG001|Outcome|1/2 Hour Group|"Foot stimulation will be applied daily for 1/2 hour in the evening.~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166040|NCT01972061|OG000|Outcome|CMG Group|"Foot stimulation will be applied during a cystometrogram (CMG).~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166041|NCT01972061|EG000|Reported Event|CMG Group|"Foot stimulation will be applied during a cystometrogram (CMG).~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166042|NCT01972061|EG001|Reported Event|3 Hours Group|"Foot stimulation will be applied daily for 3 hours in the evening.~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166043|NCT01972061|EG002|Reported Event|1/2 Hour Group|"Foot stimulation will be applied daily for 1/2 hour in the evening.~Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot."
11166044|NCT01972074|BG000|Baseline|Memantine|"Participants in the memantine arm will receive memantine in capsule form twice daily. It will be administered twice daily for 12 weeks (including a 4-week titration phase to a maximum dose of 20 mg per day). Participants will undergo neuroimaging before and after the 12-week treatment phase.~Memantine: Capsule"
11166045|NCT01972074|BG001|Baseline|Placebo|"Participants in the placebo arm will receive placebo (no active ingredients) in capsule form twice daily. It will be administered twice daily for 12 weeks. Participants will undergo neuroimaging before and after the 12-week treatment phase.~Placebo: Capsule"
11349534|NCT04082819|OG001|Outcome|Medium Blood Pressure|Systolic score between 130 - 160mmHg.
11349535|NCT04082819|OG002|Outcome|High Blood Pressure|Systolic score greater than 161mmHg.
11349536|NCT04082819|OG000|Outcome|Low Diastolic Blood Pressure|Diastolic score between 40-79mmHg.
11349537|NCT04082819|OG001|Outcome|Medium Diastolic Blood Pressure|Diastolic score between 80-100mmHg.
11349538|NCT04082819|OG002|Outcome|High Diastolic Blood Pressure|Diastolic score greater than 101mmHg.
11349539|NCT04082819|EG000|Reported Event|Low Blood Pressure|"Low blood pressure (systolic: 0-129, diastolic: 0-79)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349540|NCT04082819|EG001|Reported Event|Medium Blood Pressure|"Medium blood pressure (systolic: 130-160, diastolic: 80-100)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349541|NCT04082819|EG002|Reported Event|High Blood Pressure|"High blood pressure (systolic: 161 or higher, diastolic: 101 or higher)~Contec CMS50EW: Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.~Sphygmomanometer: Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit."
11349542|NCT04081961|BG000|Baseline|Asymptomatic Current Smokers|"No respiratory symptoms and preserved pulmonary function based on spirometry (FEV1/FVC of at least 0.70 after bronchodilation treatment and FVC ≥80% of the expected value)~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349543|NCT04081961|BG001|Baseline|"Grey Zone Current Smokers"|"Initially preserved pulmonary function based on spirometry, but with clinical symptoms based on COPD Assessment Test (CAT≥10) and results of the 6-min walk test (6 MWT) less than 450 meters.~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349544|NCT04081961|BG002|Baseline|Current Smokers With COPD|"Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III)~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349545|NCT04081961|BG003|Baseline|Total|Total of all reporting groups
11349546|NCT04081961|FG000|Participant Flow|Asymptomatic Current Smokers|"No respiratory symptoms and preserved pulmonary function based on spirometry (FEV1/FVC of at least 0.70 after bronchodilation treatment and FVC ≥80% of the expected value)~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349547|NCT04081961|FG001|Participant Flow|"Grey Zone Current Smokers"|"Initially preserved pulmonary function based on spirometry, but with clinical symptoms based on COPD Assessment Test (CAT≥10) and results of the 6-min walk test (6 MWT) less than 450 meters.~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349548|NCT04081961|FG002|Participant Flow|Current Smokers With COPD|"Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III)~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349549|NCT04081961|OG000|Outcome|Asymptomatic Current Smokers|"No respiratory symptoms and preserved pulmonary function based on spirometry (FEV1/FVC of at least 0.70 after bronchodilation treatment and FVC ≥80% of the expected value)~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349550|NCT04081961|OG001|Outcome|"Grey Zone Current Smokers"|"Initially preserved pulmonary function based on spirometry, but with clinical symptoms based on COPD Assessment Test (CAT≥10) and results of the 6-min walk test (6 MWT) less than 450 meters.~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349551|NCT04081961|OG002|Outcome|Current Smokers With COPD|"Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III)~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349552|NCT04081961|EG000|Reported Event|Asymptomatic Current Smokers|"No respiratory symptoms and preserved pulmonary function based on spirometry (FEV1/FVC of at least 0.70 after bronchodilation treatment and FVC ≥80% of the expected value)~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11166046|NCT01972074|BG002|Baseline|Control Group|Healthy controls will undergo neuroimaging twice (12 weeks apart) and will receive no intervention during the 12-week window.
11349553|NCT04081961|EG001|Reported Event|"Grey Zone Current Smokers"|"Initially preserved pulmonary function based on spirometry, but with clinical symptoms based on COPD Assessment Test (CAT≥10) and results of the 6-min walk test (6 MWT) less than 450 meters.~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349554|NCT04081961|EG002|Reported Event|Current Smokers With COPD|"Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III)~Anamed OEM device; Air Next mobile spirometry device: Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device"
11349555|NCT04081610|BG000|Baseline|Lagricel® Ofteno Multidose|"Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia~lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes~- Route of administration: Ophthalmic"
11166047|NCT01972074|BG003|Baseline|Total|Total of all reporting groups
11228858|NCT02393547|FG000|Participant Flow|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
11228859|NCT02393547|OG000|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
11228860|NCT02393547|EG000|Reported Event|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
11228861|NCT02393677|BG000|Baseline|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
11228862|NCT02393677|BG001|Baseline|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
11228863|NCT02393677|BG002|Baseline|Total|Total of all reporting groups
11228864|NCT02393677|FG000|Participant Flow|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
11228865|NCT02393677|FG001|Participant Flow|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
11228866|NCT02393677|OG000|Outcome|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
11228867|NCT02393677|OG001|Outcome|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
11228868|NCT02393677|EG000|Reported Event|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
11228869|NCT02393677|EG001|Reported Event|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
11228870|NCT02393755|BG000|Baseline|Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg|"Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid~Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose."
11228871|NCT02393755|BG001|Baseline|Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg|"Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid~Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose."
11228872|NCT02393755|BG002|Baseline|Total|Total of all reporting groups
11228873|NCT02393755|FG000|Participant Flow|Dose Level 1: Capecitabine at 2000 mg/2, Nintedanib at 150 mg|"Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid~Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose."
11228874|NCT02393755|FG001|Participant Flow|Dose Level 2: Capecitabine at 2000 mg/m2, Nintedanib at 200 mg|"Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid~Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose."
11228875|NCT02393755|OG000|Outcome|Treatment (Capecitabine, Nintedanib)|"Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Nintedanib: Given PO~Pharmacological Study: Correlative studies"
11228876|NCT02393755|EG000|Reported Event|Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg|"Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid~Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose."
11228877|NCT02393755|EG001|Reported Event|Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg|"Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid~Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose."
11228878|NCT02393950|BG000|Baseline|Panel 1|Single oral doses ODM-106 Capsule B 2, 10, 25, 50mg, placebo
11228879|NCT02393950|BG001|Baseline|Panel 2|Single oral doses ODM-106 Capsule B 100, 100, 200 mg. ODM-106 Capsule A 100mg, placebo
11228880|NCT02393950|BG002|Baseline|Total|Total of all reporting groups
11228881|NCT02393950|FG000|Participant Flow|Panel 1|Single oral doses ODM-106 Capsule B: 2, 10, 25, 50 mg , placebo
11166048|NCT01972074|FG000|Participant Flow|Memantine|"Participants in the memantine arm will receive memantine in capsule form twice daily. It will be administered twice daily for 12 weeks (including a 4-week titration phase to a maximum dose of 20 mg per day). Participants will undergo neuroimaging before and after the 12-week treatment phase.~Memantine: Capsule"
11166049|NCT01972074|FG001|Participant Flow|Placebo|"Participants in the placebo arm will receive placebo (no active ingredients) in capsule form twice daily. It will be administered twice daily for 12 weeks. Participants will undergo neuroimaging before and after the 12-week treatment phase.~Placebo: Capsule"
11166050|NCT01972074|FG002|Participant Flow|Control Group|Healthy controls will undergo neuroimaging twice (12 weeks apart) and will receive no intervention during the 12-week window.
11166051|NCT01972074|OG000|Outcome|Memantine|"Participants in the memantine arm will receive memantine in capsule form twice daily. It will be administered twice daily for 12 weeks (including a 4-week titration phase to a maximum dose of 20 mg per day). Participants will undergo neuroimaging before and after the 12-week treatment phase.~Memantine: Capsule"
11166052|NCT01972074|OG001|Outcome|Placebo|"Participants in the placebo arm will receive placebo (no active ingredients) in capsule form twice daily. It will be administered twice daily for 12 weeks. Participants will undergo neuroimaging before and after the 12-week treatment phase.~Placebo: Capsule"
11166053|NCT01972074|EG000|Reported Event|Memantine|"Participants in the memantine arm will receive memantine in capsule form twice daily. It will be administered twice daily for 12 weeks (including a 4-week titration phase to a maximum dose of 20 mg per day). Participants will undergo neuroimaging before and after the 12-week treatment phase.~Memantine: Capsule"
11166054|NCT01972074|EG001|Reported Event|Placebo|"Participants in the placebo arm will receive placebo (no active ingredients) in capsule form twice daily. It will be administered twice daily for 12 weeks. Participants will undergo neuroimaging before and after the 12-week treatment phase.~Placebo: Capsule"
11166055|NCT01972074|EG002|Reported Event|Control Group|Healthy controls will undergo neuroimaging twice (12 weeks apart) and will receive no intervention during the 12-week window.
11166056|NCT01972152|BG000|Baseline|Total Study Group|Includes all 30 randomized subjects
11166057|NCT01972152|FG000|Participant Flow|G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
11166058|NCT01972152|FG001|Participant Flow|G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 2, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
11166059|NCT01972152|FG002|Participant Flow|G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
11166060|NCT01972152|FG003|Participant Flow|G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection of at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 3.
11166061|NCT01972152|FG004|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
11166062|NCT01972152|FG005|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 3.
11166063|NCT01972152|OG000|Outcome|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
11166064|NCT01972152|OG001|Outcome|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
11166065|NCT01972152|OG002|Outcome|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
11166066|NCT01972152|OG000|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
11166067|NCT01972152|OG001|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
11166068|NCT01972152|OG002|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
11166069|NCT01972152|EG000|Reported Event|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
11166070|NCT01972152|EG001|Reported Event|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
11166071|NCT01972152|EG002|Reported Event|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
11166072|NCT01972204|BG000|Baseline|Intensive Adherence Instruction|"Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure~Intensive adherence instruction: Instruction with educational brochure"
11166073|NCT01972204|BG001|Baseline|Control|"The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.~Control: Instruction as per usual practice"
11166074|NCT01972204|BG002|Baseline|Total|Total of all reporting groups
11349556|NCT04081610|BG001|Baseline|Lagricel® Ofteno Single Dose|"Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia~lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes~- Route of administration: Ophthalmic"
11349557|NCT04081610|BG002|Baseline|Total|Total of all reporting groups
11349558|NCT04081610|FG000|Participant Flow|Lagricel® Ofteno Multidose|"Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia~lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes~- Route of administration: Ophthalmic"
11349559|NCT04081610|FG001|Participant Flow|Lagricel® Ofteno Single Dose|"Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia~lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes~- Route of administration: Ophthalmic"
11349560|NCT04081610|OG000|Outcome|Lagricel® Ofteno Multidose|"Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia~lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes~- Route of administration: Ophthalmic"
11349561|NCT04081610|OG001|Outcome|Lagricel® Ofteno Single Dose|"Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia~lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes~- Route of administration: Ophthalmic"
11349562|NCT04081610|EG000|Reported Event|Lagricel® Ofteno Multidose|"Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia~lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes~- Route of administration: Ophthalmic"
11349563|NCT04081610|EG001|Reported Event|Lagricel® Ofteno Single Dose|"Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia~lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes~- Route of administration: Ophthalmic"
10887784|NCT00502697|EG000|Reported Event|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
11349564|NCT04081324|BG000|Baseline|Placebo|Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).
11349565|NCT04081324|BG001|Baseline|50 mg Lasmiditan|Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349566|NCT04081324|BG002|Baseline|100 mg Lasmiditan|Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349567|NCT04081324|BG003|Baseline|200 mg Lasmiditan|Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349568|NCT04081324|BG004|Baseline|Total|Total of all reporting groups
11349569|NCT04081324|FG000|Participant Flow|Placebo|Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).
11349570|NCT04081324|FG001|Participant Flow|50 Milligram (mg) Lasmiditan|Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349571|NCT04081324|FG002|Participant Flow|100 mg Lasmiditan|Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349572|NCT04081324|FG003|Participant Flow|200 mg Lasmiditan|Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349573|NCT04081324|OG000|Outcome|50 mg Lasmiditan|Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349574|NCT04081324|OG001|Outcome|100 mg Lasmiditan|Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349575|NCT04081324|OG002|Outcome|200 mg Lasmiditan|Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349576|NCT04081324|EG000|Reported Event|Placebo|Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).
11349577|NCT04081324|EG001|Reported Event|50 mg Lasmiditan|Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349578|NCT04081324|EG002|Reported Event|100 mg Lasmiditan|Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349579|NCT04081324|EG003|Reported Event|200 mg Lasmiditan|Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
11349580|NCT04079790|BG000|Baseline|Gepotidacin (A/C/E)|Adult participants were randomized to receive a single dose of gepotidacin 1500 milligrams (mg) (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 12 hours (Treatment C) on Day 5 of Period 2, and two doses of gepotidacin 3000 mg separated by 6 hours (Treatment E) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
11349581|NCT04079790|BG001|Baseline|Placebo (B/D/F)|Adult participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 12 hours (Treatment D) on Day 5 of Period 2, and two doses of gepotidacin matching placebo separated by 6 hours (Treatment F) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
11349582|NCT04079790|BG002|Baseline|Gepotidacin (A/G)|Adolescent participants were randomized to receive a single dose of gepotidacin 1500 mg (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 6 hours (Treatment G) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
11349583|NCT04079790|BG003|Baseline|Placebo (B/H)|Adolescent participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 6 hours (Treatment H) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
11349584|NCT04079790|BG004|Baseline|Total|Total of all reporting groups
11349585|NCT04079790|FG000|Participant Flow|Gepotidacin (A/C/E)|Adult participants were randomized to receive a single dose of gepotidacin 1500 milligrams (mg) (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 12 hours (Treatment C) on Day 5 of Period 2, and two doses of gepotidacin 3000 mg separated by 6 hours (Treatment E) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
11349586|NCT04079790|FG001|Participant Flow|Placebo (B/D/F)|Adult participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 12 hours (Treatment D) on Day 5 of Period 2, and two doses of gepotidacin matching placebo separated by 6 hours (Treatment F) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
11166075|NCT01972204|FG000|Participant Flow|Intensive Adherence Instruction|"Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure~Intensive adherence instruction: Instruction with educational brochure"
11166076|NCT01972204|FG001|Participant Flow|Control|"The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.~Control: Instruction as per usual practice"
11349587|NCT04079790|FG002|Participant Flow|Gepotidacin (A/G)|Adolescent participants were randomized to receive a single dose of gepotidacin 1500 mg (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 6 hours (Treatment G) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
11349588|NCT04079790|FG003|Participant Flow|Placebo (B/H)|Adolescent participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 6 hours (Treatment H) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
11349589|NCT04079790|OG000|Outcome|Part 1: Gepotidacin 1500 mg|Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
11349590|NCT04079790|OG000|Outcome|Part 1: Gepotidacin 3000 mg 12 Hour Interval|Participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
11349591|NCT04079790|OG000|Outcome|Part 1: Gepotidacin 3000 mg 6 Hour Interval|Participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349592|NCT04079790|OG000|Outcome|Part1: Gepotidacin 3000 mg 6 Hour Interval|Participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11166077|NCT01972204|OG000|Outcome|Intensive Adherence Instruction|"Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure~Intensive adherence instruction: Instruction with educational brochure"
11166078|NCT01972204|OG001|Outcome|Control|"The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.~Control: Instruction as per usual practice"
11166079|NCT01972204|EG000|Reported Event|Intensive Adherence Instruction|"Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure~Intensive adherence instruction: Instruction with educational brochure"
11166080|NCT01972204|EG001|Reported Event|Control|"The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.~Control: Instruction as per usual practice"
11166081|NCT01972282|BG000|Baseline|WATCHMAN|Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
11166082|NCT01972282|FG000|Participant Flow|WATCHMAN|Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
11166083|NCT01972282|OG000|Outcome|WATCHMAN|Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
11166084|NCT01972282|EG000|Reported Event|WATCHMAN|Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
11166085|NCT01972308|BG000|Baseline|Patient Advocate|"Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.~Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"
11166086|NCT01972308|BG001|Baseline|Usual Care|Patient receives asthma care as usual from their asthma provider
11166087|NCT01972308|BG002|Baseline|Total|Total of all reporting groups
11166088|NCT01972308|FG000|Participant Flow|Patient Advocate|"Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.~Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"
11166089|NCT01972308|FG001|Participant Flow|Usual Care|Patient receives asthma care as usual from their asthma provider
11166090|NCT01972308|OG000|Outcome|Patient Advocate|Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
11166091|NCT01972308|OG001|Outcome|Usual Care|Patient receives asthma care as usual from their asthma provider
11166092|NCT01972308|OG000|Outcome|Patient Advocate|"Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.~Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"
11166093|NCT01972308|OG001|Outcome|Usual Care|"Patient receives asthma care as usual from their asthma provider~Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"
10887785|NCT00502697|EG001|Reported Event|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
11166094|NCT01972308|EG000|Reported Event|Patient Advocate|"Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.~Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"
11228882|NCT02393950|FG001|Participant Flow|Panel 2|Single oral doses ODM-106 Capsule B: 100, 100, 200mg. ODM-106 Capsule A 100 mg , placebo
11228883|NCT02393950|OG000|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
11228884|NCT02393950|OG001|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
11228885|NCT02393950|OG002|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
11228886|NCT02393950|OG003|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
11228887|NCT02393950|OG004|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
11228888|NCT02393950|OG005|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
10887786|NCT00502775|BG000|Baseline|Placebo|
11228889|NCT02393950|OG006|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
11228890|NCT02393950|OG007|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
11228891|NCT02393950|OG008|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
11228892|NCT02393950|OG002|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
11228893|NCT02393950|OG003|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
11228894|NCT02393950|OG004|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
11228895|NCT02393950|OG005|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
11228896|NCT02393950|OG006|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
11228897|NCT02393950|OG007|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
11228898|NCT02393950|OG002|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5mg ODM-106 Capsule B
11228899|NCT02393950|OG005|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
11228900|NCT02393950|OG007|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
11228901|NCT02393950|OG000|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B.
10887787|NCT00502775|BG001|Baseline|Fluticasone Furoate 110mcg|
10887788|NCT00502775|BG002|Baseline|Fexofenadine 180 mg|
11228902|NCT02393950|OG001|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B.
11228903|NCT02393950|OG002|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B.
11228904|NCT02393950|OG003|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B.
11228905|NCT02393950|OG004|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B.
11228906|NCT02393950|OG006|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B.
11228907|NCT02393950|EG000|Reported Event|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
11228908|NCT02393950|EG001|Reported Event|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
11228909|NCT02393950|EG002|Reported Event|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B
11228910|NCT02393950|EG003|Reported Event|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
11228911|NCT02393950|EG004|Reported Event|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
11228912|NCT02393950|EG005|Reported Event|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
11228913|NCT02393950|EG006|Reported Event|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
11228914|NCT02393950|EG007|Reported Event|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
11228915|NCT02393950|EG008|Reported Event|Placebo|2 placebo subjects per Arm with matched number of placebo capsules
11228916|NCT02394275|BG000|Baseline|Single Arm:|"Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.~Fecal Microbiota Transplant: All eligible patients will receive fecal microbiota transplant"
11228917|NCT02394275|FG000|Participant Flow|Single Arm:|"Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.~Fecal Microbiota Transplant: All eligible patients will receive fecal microbiota transplant"
11228918|NCT02394275|OG000|Outcome|Single Arm:|"Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration.~Participants on antibiotic to control CDI will discontinue antibiotic 24 - 48 hours hours prior to FMT.~Fecal Microbiota Transplant: All eligible patients will receive fecal microbiota transplant"
11228919|NCT02394275|OG000|Outcome|FMT Open-label|"Eligible patients received intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.~Fecal Microbiota Transplant: All eligible patients received fecal microbiota transplant"
11228920|NCT02394275|EG000|Reported Event|Single Arm:|"Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.~Fecal Microbiota Transplant: All eligible patients will receive fecal microbiota transplant"
11228921|NCT02394340|BG000|Baseline|Luliconazole Cream 1%|Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.
11228922|NCT02394340|FG000|Participant Flow|Luliconazole Cream 1%|Participants received 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants also received luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.
11228923|NCT02394340|OG000|Outcome|Luliconazole Cream 1%|Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.
11228924|NCT02394340|EG000|Reported Event|Luliconazole Cream 1%|Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.
11228925|NCT02394457|BG000|Baseline|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
11228926|NCT02394457|BG001|Baseline|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
11228927|NCT02394457|BG002|Baseline|Total|Total of all reporting groups
11349593|NCT04079790|OG000|Outcome|Part 2: Gepotidacin 1500 mg|Adolescent participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
11349594|NCT04079790|OG000|Outcome|Part 2-Gepotidacin 3000 mg 6 Hour Interval|Participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349595|NCT04079790|OG000|Outcome|Part 2: Gepotidacin 3000 mg 6 Hour Interval|Participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349596|NCT04079790|OG000|Outcome|Part 1: Placebo|Adult participants received a single oral dose of gepotidacin matching placebo on Day 1 of Period 1
11349597|NCT04079790|OG001|Outcome|Part 1: Gepotidacin 1500 mg|Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
11349598|NCT04079790|OG002|Outcome|Part 1: Gepotidacin 3000 mg 12 Hour Interval|Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
11349599|NCT04079790|OG003|Outcome|Part 1: Gepotidacin 3000 mg 6 Hour Interval|Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349600|NCT04079790|OG000|Outcome|Part 2: Placebo|Adolescent participants received a single oral dose of gepotidacin matching placebo on Day 1 of Period 1
11349601|NCT04079790|OG001|Outcome|Part 2: Gepotidacin 1500 mg|Adolescent participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
11349602|NCT04079790|OG002|Outcome|Part 2: Gepotidacin 3000 mg 6 Hour Interval|Adolescent participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349603|NCT04079790|OG001|Outcome|Part 1: Gepotidacin 3000 mg 12 Hour Interval|Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
11349604|NCT04079790|OG001|Outcome|Part 1: Gepotidacin 3000 mg 6 Hour Interval|Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349605|NCT04079790|OG001|Outcome|Part 2: Gepotidacin 3000 mg 6 Hour Interval|Adolescent participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349606|NCT04079790|EG000|Reported Event|Part 1 : Placebo|Adult participants received a single oral dose of gepotidacin matching placebo on Day 1 of Period 1
11349607|NCT04079790|EG001|Reported Event|Part1: Gepotidacin 1500 mg|Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
11349608|NCT04079790|EG002|Reported Event|Part 1: Gepotidacin 3000 mg 12 Hour Interval|Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
11349609|NCT04079790|EG003|Reported Event|Part 1: Gepotidacin 3000 mg 6 Hour Interval|Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349610|NCT04079790|EG004|Reported Event|Part 2 : Placebo|Adolescent participants received a single oral dose of gepotidacin matching placebo on Day 1 of Period 1
11349611|NCT04079790|EG005|Reported Event|Part 2: Gepotidacin 1500 mg|Adolescent participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
11349612|NCT04079790|EG006|Reported Event|Part 2: Gepotidacin 3000 mg 6 Hour Interval|Adolescent participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
11349613|NCT04079127|BG000|Baseline|Patients Suffering From Severe Hip Pain and Disability|"Patients in need of a total hip arthroplasty.~Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem and who met the study inclusion/exclusion criteria ."
11349614|NCT04079127|FG000|Participant Flow|Patients Suffering From Severe Hip Pain and Disability|"Patients in need of a total hip arthroplasty.~Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem."
11349615|NCT04079127|OG000|Outcome|Patients Suffering From Severe Hip Pain and Disability|"Patients in need of a total hip arthroplasty.~Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem."
11349616|NCT04079127|EG000|Reported Event|Patients Suffering From Severe Hip Pain and Disability|"Patients in need of a total hip arthroplasty.~Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem."
11349617|NCT04076787|BG000|Baseline|IMDC Prognostic Risk Group: Favorable|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as favorable survival group (with no IMDC risk factor).
11349618|NCT04076787|BG001|Baseline|IMDC Prognostic Risk Group: Intermediate|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as intermediate survival group (with 1 or 2 IMDC risk factor).
11349619|NCT04076787|BG002|Baseline|IMDC Prognostic Risk Group: Poor|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as poor survival group (with 3 or more than 3 IMDC risk factor).
11349620|NCT04076787|BG003|Baseline|Total|Total of all reporting groups
11349621|NCT04076787|FG000|Participant Flow|IMDC Prognostic Risk Group: Favorable|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as favorable survival group (with no IMDC risk factor).
11349622|NCT04076787|FG001|Participant Flow|IMDC Prognostic Risk Group: Intermediate|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as intermediate survival group (with 1 or 2 IMDC risk factor).
11349623|NCT04076787|FG002|Participant Flow|IMDC Prognostic Risk Group: Poor|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as poor survival group (with 3 or more than 3 IMDC risk factor).
11089341|NCT01523457|FG000|Participant Flow|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
11089342|NCT01523457|FG001|Participant Flow|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
11089343|NCT01523457|OG000|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
11228928|NCT02394457|FG000|Participant Flow|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
11228929|NCT02394457|FG001|Participant Flow|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
11228930|NCT02394457|OG000|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
11228931|NCT02394457|OG001|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
11228932|NCT02394457|EG000|Reported Event|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
11228933|NCT02394457|EG001|Reported Event|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
11228934|NCT02394561|BG000|Baseline|Cw6-positive AIN457 300 mg|Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
11228935|NCT02394561|BG001|Baseline|Cw6-negative AIN457 300 mg|Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
11228936|NCT02394561|BG002|Baseline|Total|Total of all reporting groups
11228937|NCT02394561|FG000|Participant Flow|Cw6-positive AIN457 300 mg|Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
11228938|NCT02394561|FG001|Participant Flow|Cw6-negative AIN457 300 mg|Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
11228939|NCT02394561|OG000|Outcome|Cw6-positive AIN457 300 mg|Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
11228940|NCT02394561|OG001|Outcome|Cw6-negative AIN457 300 mg|Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
11228941|NCT02394561|OG002|Outcome|Difference in % (Cw6-pos vs Cw6-neg)|Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
11228942|NCT02394561|OG000|Outcome|All Patients|All patients in the Safety Set.
10887789|NCT00502775|BG003|Baseline|Total|Total of all reporting groups
11166095|NCT01972308|EG001|Reported Event|Usual Care|"Patient receives asthma care as usual from their asthma provider~Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"
11166096|NCT01972438|BG000|Baseline|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
11166097|NCT01972438|BG001|Baseline|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
11166098|NCT01972438|BG002|Baseline|Total|Total of all reporting groups
11166099|NCT01972438|FG000|Participant Flow|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
11166100|NCT01972438|FG001|Participant Flow|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
11166101|NCT01972438|OG000|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
11166102|NCT01972438|OG001|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
11166103|NCT01972438|EG000|Reported Event|ASEDs|Adverse event occurred when participants were receiving autologous serum eye drops (ASEDs) daily during the crossover period (first six months) of the study.
11166104|NCT01972438|EG001|Reported Event|Saline|Adverse event occurred when participants were receiving control (normal saline) eye drops daily during the crossover period (first six months) of the study.
11166105|NCT01972438|EG002|Reported Event|ASEDs or Saline|Adverse event occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops daily if desired.
11166106|NCT01972438|EG003|Reported Event|No Intervention|Adverse event occurred prior to participants receiving either intervention. Neither ASEDs nor normal saline eye drops were being taken when the event occurred.
11166107|NCT01972464|BG000|Baseline|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
11166108|NCT01972464|BG001|Baseline|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
11166109|NCT01972464|BG002|Baseline|Total|Total of all reporting groups
11166110|NCT01972464|FG000|Participant Flow|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
11166111|NCT01972464|FG001|Participant Flow|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
11166112|NCT01972464|OG000|Outcome|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
11166113|NCT01972464|OG001|Outcome|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
11166114|NCT01972464|OG001|Outcome|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone: oral micronized progesterone"
11166115|NCT01972464|EG000|Reported Event|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
11166116|NCT01972464|EG001|Reported Event|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
11166117|NCT01972516|BG000|Baseline|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
11166118|NCT01972516|BG001|Baseline|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
11166119|NCT01972516|BG002|Baseline|Total|Total of all reporting groups
11166120|NCT01972516|FG000|Participant Flow|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
11166121|NCT01972516|FG001|Participant Flow|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
11166122|NCT01972516|OG000|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
11166123|NCT01972516|OG001|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
11228943|NCT02394561|OG000|Outcome|All Patients|All patients in the Safety Set
11228944|NCT02394561|EG000|Reported Event|Cw6-Negative AIN457 300 mg|Cw6-Negative AIN457 300 mg
10887790|NCT00502775|FG000|Participant Flow|Placebo|
11349624|NCT04076787|OG000|Outcome|IMDC Prognostic Risk Group: Favorable|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as favorable survival group (with no IMDC risk factor).
11349625|NCT04076787|OG001|Outcome|IMDC Prognostic Risk Group: Intermediate|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as intermediate survival group (with 1 or 2 IMDC risk factor).
11349626|NCT04076787|OG002|Outcome|IMDC Prognostic Risk Group: Poor|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as poor survival group (with 3 or more than 3 IMDC risk factor).
11349627|NCT04076787|EG000|Reported Event|IMDC Prognostic Risk Group: Favorable|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as favorable survival group (with no IMDC risk factor).
11349628|NCT04076787|EG001|Reported Event|IMDC Prognostic Risk Group: Intermediate|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as intermediate survival group (with 1 or 2 IMDC risk factor).
11349629|NCT04076787|EG002|Reported Event|IMDC Prognostic Risk Group: Poor|Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as poor survival group (with 3 or more than 3 IMDC risk factor).
11349630|NCT04075812|BG000|Baseline|Neuromuscular Stimulator|"Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements.~Neuromuscular Stimulator"
11349631|NCT04075812|FG000|Participant Flow|Neuromuscular Stimulator|"Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements.~Neuromuscular Stimulator"
11349632|NCT04075812|OG000|Outcome|Neuromuscular Stimulator|"Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements.~Neuromuscular Stimulator"
11349633|NCT04075812|EG000|Reported Event|Neuromuscular Stimulator|"Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements.~Neuromuscular Stimulator"
11349634|NCT04075409|BG000|Baseline|Extensive Metabolizers|Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of padsevonil (PSL) 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg twice a day (BID) on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
11349635|NCT04075409|BG001|Baseline|Intermediate Metabolizers|Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
11349636|NCT04075409|BG002|Baseline|Poor Metabolizers|Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
10887791|NCT00502775|FG001|Participant Flow|Fluticasone Furoate 110mcg|
11349637|NCT04075409|BG003|Baseline|Total Title|
11349638|NCT04075409|FG000|Participant Flow|Extensive Metabolizers|Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of padsevonil (PSL) 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg twice a day (BID) on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
11349639|NCT04075409|FG001|Participant Flow|Intermediate Metabolizers|Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
11349640|NCT04075409|FG002|Participant Flow|Poor Metabolizers|Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
11349641|NCT04075409|OG000|Outcome|Poor Metabolizers (PK-PPS)|Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
10887792|NCT00502775|FG002|Participant Flow|Fexofenadine 180 mg|
10887793|NCT00502775|OG000|Outcome|Placebo|
10887794|NCT00502775|OG001|Outcome|Fluticasone Furoate 110mcg|
10887795|NCT00502775|OG002|Outcome|Fexofenadine 180 mg|
10887796|NCT00502775|EG000|Reported Event|Placebo|
11349642|NCT04075409|OG001|Outcome|Intermediate Metabolizers (PK-PPS)|Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
11349643|NCT04075409|OG002|Outcome|Extensive Metabolizers (PK-PPS)|Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
11349644|NCT04075409|OG000|Outcome|Extensive Metabolizers (PK-PPS)|Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
11349645|NCT04075409|OG002|Outcome|Poor Metabolizers (PK-PPS)|Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
11349646|NCT04075409|OG000|Outcome|Extensive Metabolizers Single Dose (SS)|Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
11349647|NCT04075409|OG001|Outcome|Intermediate Metabolizers Single Dose (SS)|Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
11349648|NCT04075409|OG002|Outcome|Poor Metabolizers Single Dose (SS)|Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
11349649|NCT04075409|OG003|Outcome|Extensive Metabolizers Multiple Dose (SS)|Extensive metabolizers (Participants confirmed with genotype *1/*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
11349650|NCT04075409|OG004|Outcome|Intermediate Metabolizers Multiple Dose (SS)|Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
11349651|NCT04075409|OG005|Outcome|Poor Metabolizers Multiple Dose (SS)|Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
11349652|NCT04075409|EG000|Reported Event|Extensive Metabolizers Single Dose (SS)|Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
11349653|NCT04075409|EG001|Reported Event|Intermediate Metabolizers Single Dose (SS)|Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
11349654|NCT04075409|EG002|Reported Event|Poor Metabolizers Single Dose (SS)|Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
11349655|NCT04075409|EG003|Reported Event|Extensive Metabolizers Multiple Dose (SS)|Extensive metabolizers (Participants confirmed with genotype *1/*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
11349656|NCT04075409|EG004|Reported Event|Intermediate Metabolizers Multiple Dose (SS)|Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
11349657|NCT04075409|EG005|Reported Event|Poor Metabolizers Multiple Dose (SS)|Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
11349658|NCT04074941|BG000|Baseline|Low Sodium Diet|"This group will get a low sodium diet (<0.9 mg per kcal of energy intake).~Dietary intervention: Intervention include low sodium or usual sodium diet"
11349659|NCT04074941|BG001|Baseline|Usual Sodium Diet|"This group will get a usual sodium diet (~2 mg per kcal of energy intake).~Dietary intervention: Intervention include low sodium or usual sodium diet"
11349660|NCT04074941|BG002|Baseline|Total|Total of all reporting groups
11349661|NCT04074941|FG000|Participant Flow|Low Sodium Diet|"This group will get a low sodium diet (<0.9 mg per kcal of energy intake).~Dietary intervention: Intervention include low sodium or usual sodium diet"
11349662|NCT04074941|FG001|Participant Flow|Usual Sodium Diet|"This group will get a usual sodium diet (~2 mg per kcal of energy intake).~Dietary intervention: Intervention include low sodium or usual sodium diet"
11228945|NCT02394561|EG001|Reported Event|Cw6-Positive AIN457 300 mg|Cw6-Positive AIN457 300 mg
11228946|NCT02394600|BG000|Baseline|Grastek|4 months of once per day Grastek sublingual immunotherapy
11228947|NCT02394600|BG001|Baseline|Placebo|4 months of once per day matching placebo sublingual tablet
11228948|NCT02394600|BG002|Baseline|Total|Total of all reporting groups
11228949|NCT02394600|FG000|Participant Flow|Grastek|4 months of once per day Grastek sublingual immunotherapy
11228950|NCT02394600|FG001|Participant Flow|Placebo|4 months of once per day matching placebo sublingual tablet
11228951|NCT02394600|OG000|Outcome|Grastek|4 months of once per day Grastek sublingual immunotherapy
11228952|NCT02394600|OG001|Outcome|Placebo|4 months of once per matching placebo sublingual tablet
11228953|NCT02394600|EG000|Reported Event|Grastek®|4 months of once per day Grastek sublingual immunotherapy
11228954|NCT02394600|EG001|Reported Event|Placebo|4 months of once per day matching placebo sublingual tablet
11228955|NCT02394730|BG000|Baseline|Vorapaxar|"2.5mg of vorapaxar po qd~vorapaxar: 2.5mg of vorapaxar taken orally once daily for 12 weeks"
11228956|NCT02394730|BG001|Baseline|Placebo|"sugar pill po qd~Placebo: Sugar pill taken orally once daily for 12 weeks"
11228957|NCT02394730|BG002|Baseline|Total|Total of all reporting groups
11228958|NCT02394730|FG000|Participant Flow|Vorapaxar|"2.5mg of vorapaxar po qd~vorapaxar: 2.5mg of vorapaxar taken orally once daily for 12 weeks"
11228959|NCT02394730|FG001|Participant Flow|Placebo|"sugar pill po qd~Placebo: Sugar pill taken orally once daily for 12 weeks"
11228960|NCT02394730|OG000|Outcome|Vorapaxar|"2.5mg of vorapaxar po qd~vorapaxar: 2.5mg of vorapaxar taken orally once daily for 12 weeks"
11228961|NCT02394730|OG001|Outcome|Placebo|"sugar pill po qd~Placebo: Sugar pill taken orally once daily for 12 weeks"
11228962|NCT02394730|EG000|Reported Event|Vorapaxar|"2.5mg of vorapaxar po qd~vorapaxar: 2.5mg of vorapaxar taken orally once daily for 12 weeks"
11228963|NCT02394730|EG001|Reported Event|Placebo|"sugar pill po qd~Placebo: Sugar pill taken orally once daily for 12 weeks"
11228964|NCT02394756|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least 1 study lens.
11228965|NCT02394756|FG000|Participant Flow|Senofilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence wore the senofilcon A lens in the first period, the lotrafilcon B lens in the second period and the comfilcon A lens in the third period.
11228966|NCT02394756|FG001|Participant Flow|Senfilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence wore the senofilcon A lens in the first period, the comfilcon A lens in the second period and the lotrafilcon B lens in the third period.
11228967|NCT02394756|FG002|Participant Flow|Lotrafilcon B/Comfilcon A/Senofilcon A|Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the comfilcon A lens in the second period and the senofilcon A lens in the third period.
11228968|NCT02394756|FG003|Participant Flow|Lotrafilcon B/Senofilcon A/Comfilcon A|Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the senofilcon A lens in the second period and the comfilcon A lens in the third period.
11228969|NCT02394756|FG004|Participant Flow|Comfilcon A/Senofilcon A/ Lotrafilcon B|Subjects randomized to this sequence wore the comfilcon A lens in the first period, the senofilcon A lens in the second period and the lotrafilcon B lens in the third period.
11228970|NCT02394756|FG005|Participant Flow|Comfilcon A/Lotrafilcon B/Senofilcon A|Subjects randomized to this sequence wore the comfilcon A lens in the first period, the lotrafilcon B lens in the second period and the senofilcon A lens in the third period.
11228971|NCT02394756|OG000|Outcome|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
11349663|NCT04074941|OG000|Outcome|Low Sodium Diet|"This group will get a low sodium diet (<0.9 mg per kcal of energy intake).~Dietary intervention: Intervention include low sodium or usual sodium diet"
11349664|NCT04074941|OG001|Outcome|Usual Sodium Diet|"This group will get a usual sodium diet (~2 mg per kcal of energy intake).~Dietary intervention: Intervention include low sodium or usual sodium diet"
11349665|NCT04074941|EG000|Reported Event|Low Sodium Diet|"This group will get a low sodium diet (<0.9 mg per kcal of energy intake).~Dietary intervention: Intervention include low sodium or usual sodium diet"
11349666|NCT04074941|EG001|Reported Event|Usual Sodium Diet|"This group will get a usual sodium diet (~2 mg per kcal of energy intake).~Dietary intervention: Intervention include low sodium or usual sodium diet"
11349667|NCT04073823|BG000|Baseline|Flexitouch Plus|Flexitouch Plus: Flexitouch Plus full arm and core treatment
11349668|NCT04073823|BG001|Baseline|Flexitouch Plus With SW|Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
11349669|NCT04073823|BG002|Baseline|Total|Total of all reporting groups
11349670|NCT04073823|FG000|Participant Flow|Flexitouch Plus|Flexitouch Plus: Flexitouch Plus full arm and core treatment
11349671|NCT04073823|FG001|Participant Flow|Flexitouch Plus With SW|Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
11349672|NCT04073823|OG000|Outcome|Flexitouch Plus|Flexitouch Plus: Flexitouch Plus full arm and core treatment
11349673|NCT04073823|OG001|Outcome|Flexitouch Plus With SW|Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
11349674|NCT04073823|EG000|Reported Event|Flexitouch Plus|Flexitouch Plus: Flexitouch Plus full arm and core treatment
11349675|NCT04073823|EG001|Reported Event|Flexitouch Plus With SW|Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
10887797|NCT00502775|EG001|Reported Event|Fluticasone Furoate 110mcg|
11349676|NCT04073407|BG000|Baseline|AXA1957|"AXA1957 20.4g~AXA1957: Amino acids, food study"
11349677|NCT04073407|BG001|Baseline|Placebo|"Placebo 24g~Placebo: placebo"
11349678|NCT04073407|BG002|Baseline|Total|Total of all reporting groups
11349679|NCT04073407|FG000|Participant Flow|AXA1957|"AXA1957 20.4g~AXA1957: Amino acids, food study"
11349680|NCT04073407|FG001|Participant Flow|Placebo|"Placebo 24g~Placebo: placebo"
11349681|NCT04073407|OG000|Outcome|AXA1957|"AXA1957 20.4g~AXA1957: Amino acids, food study"
11349682|NCT04073407|OG001|Outcome|Placebo|"Placebo 24g~Placebo: placebo"
11349683|NCT04073407|EG000|Reported Event|AXA1957|"AXA1957 20.4g~AXA1957: Amino acids, food study"
11349684|NCT04073407|EG001|Reported Event|Placebo|"Placebo 24g~Placebo: placebo"
11349685|NCT04073368|BG000|Baseline|AXA1957 High Dose|"AXA1957 20.3g~AXA1957: Amino acids, food study"
11349686|NCT04073368|BG001|Baseline|AXA1957 Low Dose|"AXA1957 13.5g~AXA1957: Amino acids, food study"
11349687|NCT04073368|BG002|Baseline|AXA1125|"AXA1125 24g~AXA1125: Amino acids, food study"
11349688|NCT04073368|BG003|Baseline|Placebo|"Placebo 24g~Placebo: Amino acids, food study"
11349689|NCT04073368|BG004|Baseline|Total|Total of all reporting groups
11349690|NCT04073368|FG000|Participant Flow|AXA1957 High Dose|"AXA1957 20.3g~AXA1957: Amino acids, food study"
11349691|NCT04073368|FG001|Participant Flow|AXA1957 Low Dose|"AXA1957 13.5g~AXA1957: Amino acids, food study"
11349692|NCT04073368|FG002|Participant Flow|AXA1125|"AXA1125 24g~AXA1125: Amino acids, food study"
10887798|NCT00502775|EG002|Reported Event|Fexofenadine 180 mg|
10887799|NCT00502801|BG000|Baseline|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
11349693|NCT04073368|FG003|Participant Flow|Placebo|"Placebo 24g~Placebo: Amino acids, food study"
11349694|NCT04073368|OG000|Outcome|AXA1957 High Dose|"AXA1957 20.3g~AXA1957: Amino acids, food study"
11349695|NCT04073368|OG001|Outcome|AXA1957 Low Dose|"AXA1957 13.5g~AXA1957: Amino acids, food study"
11349696|NCT04073368|OG002|Outcome|AXA1125|"AXA1125 24g~AXA1125: Amino acids, food study"
11349697|NCT04073368|OG003|Outcome|Placebo|"Placebo 24g~Placebo: Amino acids, food study"
11349698|NCT04073368|EG000|Reported Event|AXA1957 High Dose|"AXA1957 20.3g~AXA1957: Amino acids, food study"
11349699|NCT04073368|EG001|Reported Event|AXA1957 Low Dose|"AXA1957 13.5g~AXA1957: Amino acids, food study"
11349700|NCT04073368|EG002|Reported Event|AXA1125|"AXA1125 24g~AXA1125: Amino acids, food study"
11349701|NCT04073368|EG003|Reported Event|Placebo|"Placebo 24g~Placebo: Amino acids, food study"
11349702|NCT04073186|BG000|Baseline|Test|Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each.
11349703|NCT04073186|FG000|Participant Flow|Test|Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each.
11349704|NCT04073186|OG000|Outcome|Test (First Wearing Cycle)|All subjects that wore the Test lens during the first wearing cycle
11349705|NCT04073186|OG001|Outcome|Test (Second Wearing Cycle)|All subjects that wore the Test lens during the second wearing cycle
11349706|NCT04073186|EG000|Reported Event|Test|Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each.
11349707|NCT04072237|BG000|Baseline|Study Population|MarzAA (Marzeptacog Alfa [activated], Coagulation Factor VIIa variant) 18 µg/kg intravenously (Stage 1) followed by MarzAA 30 µg/kg subcutaneously (SC) (Stage 2), MarzAA 45 µg/kg SC (Stage 3), MarzAA 60 µg/kg SC (Stage 4), MarzAA 2x30 µg/kg SC (Stage 5), MarzAA 90 µg/kg SC (Stage 6), MarzAA 120 µg/kg SC (Stage 7), MarzAA 2×60 µg/kg SC (Stage 8), MarzAA 3x60 µg/kg SC (Stage 9)
11349708|NCT04072237|FG000|Participant Flow|Overall Study Population|Coagulation Factor VIIa variant: Single intravenous dose and ascending doses of subcutaneous injection of MarzAA
11349709|NCT04072237|OG000|Outcome|Stage 1 MarzAA 18 µg/kg IV|Single intravenous dose of MarzAA, coagulation factor VIIa variant
11349710|NCT04072237|OG001|Outcome|Stage 2 MarzAA 30 µg/kg SC|Single subcutaneous injection of MarzAA, coagulation factor VIIa variant
11349711|NCT04072237|OG002|Outcome|Stage 3 MarzAA 45 µg/kg SC|Single subcutaneous injection of MarzAA, coagulation factor VIIa variant
11349712|NCT04072237|OG003|Outcome|Stage 4 MarzAA 60 µg/kg SC|Single subcutaneous injection of MarzAA, coagulation factor VIIa variant
11228972|NCT02394756|OG001|Outcome|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
11228973|NCT02394756|OG002|Outcome|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
11228974|NCT02394756|EG000|Reported Event|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
11228975|NCT02394756|EG001|Reported Event|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
11228976|NCT02394756|EG002|Reported Event|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
11228977|NCT02394769|BG000|Baseline|Placebo (For Aspirin)|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.~Placebo for Aspirin"
11228978|NCT02394769|BG001|Baseline|Low Dose Aspirin|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.~Aspirin"
11228979|NCT02394769|BG002|Baseline|Standard Dose Aspirin|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.~Aspirin"
11228980|NCT02394769|BG003|Baseline|Total|Total of all reporting groups
11228981|NCT02394769|FG000|Participant Flow|Placebo (For Aspirin)|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.~Placebo for Aspirin"
11228982|NCT02394769|FG001|Participant Flow|Low Dose Aspirin|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.~Aspirin"
11228983|NCT02394769|FG002|Participant Flow|Standard Dose Aspirin|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.~Aspirin"
11228984|NCT02394769|OG000|Outcome|Placebo (For Aspirin)|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.~Placebo for Aspirin"
11228985|NCT02394769|OG001|Outcome|Low Dose Aspirin|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.~Aspirin"
11228986|NCT02394769|OG002|Outcome|Standard Dose Aspirin|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.~Aspirin"
11228987|NCT02394769|EG000|Reported Event|Placebo (For Aspirin)|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.~Placebo for Aspirin"
11228988|NCT02394769|EG001|Reported Event|Low Dose Aspirin|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.~Aspirin"
11228989|NCT02394769|EG002|Reported Event|Standard Dose Aspirin|"The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.~Aspirin"
11228990|NCT02394808|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the duration of the study.
11228991|NCT02394808|FG000|Participant Flow|Senofilcon A/ Lotrafilcon B|Subjects randomized to this sequence first wore the senofilcon A lens and then wore the lotrafilcon B lens.
11228992|NCT02394808|FG001|Participant Flow|Lotrafilcon B/Senofilcon A|Subjects randomized to this sequence first wore the lotrafilcon B lens and then wore the senofilcon A lens.
11228993|NCT02394808|OG000|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the first or second period of the study.
11228994|NCT02394808|OG001|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
11228995|NCT02394808|EG000|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in either the first or second period of the study.
11228996|NCT02394808|EG001|Reported Event|Lotrafilcon B|Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
11228997|NCT02394912|BG000|Baseline|LUMIFI With Crux VCF System|vena cava filter implantation (LUMIFI with Crux VCF System)
11228998|NCT02394912|FG000|Participant Flow|LUMIFI With Crux VCF System|vena cava filter implantation (LUMIFI with Crux VCF System). Includes both Cohort A and Cohort B subjects.
11228999|NCT02394912|OG000|Outcome|LUMIFI With Crux VCF System|vena cava filter implantation (LUMIFI with Crux VCF System)
11229000|NCT02394912|OG001|Outcome|Cohort A|Roll-in phase consisting of 2 subjects per site to assure compliance with use of the Investigational Device
11229001|NCT02394912|OG002|Outcome|Cohort B|Subjects are enrolled into Cohort B after each site has enrolled 2 subjects in Cohort A to assure compliance with use of the Investigational Device
11229002|NCT02394912|EG000|Reported Event|LUMIFI With Crux VCF System|vena cava filter implantation (LUMIFI with Crux VCF System)
11229003|NCT02394925|BG000|Baseline|Dispensed Subjects|All subjects in that were dispensed the study lens.
11349713|NCT04072237|OG004|Outcome|Stage 5 MarzAA 2×30 µg/kg SC|Two subcutaneous injections of MarzAA, coagulation factor VIIa variant
11349714|NCT04072237|OG005|Outcome|Stage 6 MarzAA 90 µg/kg SC|Single subcutaneous injection of MarzAA, coagulation factor VIIa variant
11349715|NCT04072237|OG006|Outcome|Stage 7 MarzAA 120 µg/kg SC|Single subcutaneous injection of MarzAA, coagulation factor VIIa variant
11349716|NCT04072237|OG007|Outcome|Stage 8 2×60 µg/kg SC Q3H|Two subcutaneous injections of MarzAA, coagulation factor VIIa variant, every 3 hours
11349717|NCT04072237|OG008|Outcome|Stage 9 3×60 µg/kg SC Q3H|Three subcutaneous injections of MarzAA, coagulation factor VIIa variant, every 3 hours
11349718|NCT04072237|OG000|Outcome|Stage 4 MarzAA 60μg/kg SC|Single subcutaneous injection of MarzAA, coagulation factor VIIa variant
11349719|NCT04072237|OG001|Outcome|Stage 5 MarzAA 2×30μg/kg SC|Two subcutaneous injections of MarzAA, coagulation factor VIIa variant
11349720|NCT04072237|OG000|Outcome|Stage 4 MarzAA 60μg/kg SC|Single subcutaneous injection of MarzAA coagulation factor VIIa variant
11349721|NCT04072237|OG001|Outcome|Stage 5 MarzAA 2×30μg/kg SC|Two subcutaneous injections of MarzAA coagulation factor VIIa variant
11349722|NCT04072237|OG000|Outcome|Stage 1 MarzAA 18 µg/kg SC|Single intravenous dose of MarzAA, coagulation factor VIIa variant
11349723|NCT04072237|OG004|Outcome|Stage 5 MarzAA 2×30 µg/kg SC|Two single subcutaneous injections of MarzAA, coagulation factor VIIa variant
11349724|NCT04072237|OG008|Outcome|Stage 9 3×60 µg/kg Q3H|Three subcutaneous injections of MarzAA, coagulation factor VIIa variant, every 3 hours
11349725|NCT04072237|EG000|Reported Event|Stage 1 MarzAA 18 µg/kg SC|Single intravenous dose of MarzAA
11349726|NCT04072237|EG001|Reported Event|Stage 2 MarzAA 30 µg/kg SC|Single subcutaneous injection of MarzAA
11349727|NCT04072237|EG002|Reported Event|Stage 3 MarzAA 45 µg/kg SC|Single subcutaneous injection of MarzAA
11349728|NCT04072237|EG003|Reported Event|Stage 4 MarzAA 60 µg/kg SC|Single subcutaneous injection of MarzAA
11349729|NCT04072237|EG004|Reported Event|Stage 5 MarzAA 2×30 µg/kg SC|Two subcutaneous injections of MarzAA
11349730|NCT04072237|EG005|Reported Event|Stage 6 MarzAA 90 µg/kg SC|Single subcutaneous injection of MarzAA
11349731|NCT04072237|EG006|Reported Event|Stage 7 MarzAA 120 µg/kg SC|Single subcutaneous injection of MarzAA
10887800|NCT00502801|FG000|Participant Flow|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
10887801|NCT00502801|OG000|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
11349732|NCT04072237|EG007|Reported Event|Stage 8 MarzAA 2×60 µg/kg SC Q3H|Two subcutaneous injections of MarzAA every 3 hours
11349733|NCT04072237|EG008|Reported Event|Stage 9 MarzAA 3×60 µg/kg SC Q3H|Three subcutaneous injections of MarzAA every 3 hours
11349734|NCT04063371|BG000|Baseline|Control Group 1|At least one location will serve as the control office and will continue to conduct their visits including screening for cognitive impairment as they normally do using their usual method based on the primary care provider's normal practice.
11349735|NCT04063371|BG001|Baseline|Intervention Group|"At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.~Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE): The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.~Informant Conversation: If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year."
11349736|NCT04063371|BG002|Baseline|Control Group 2|Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
11349737|NCT04063371|BG003|Baseline|Total|Total of all reporting groups
11349738|NCT04063371|FG000|Participant Flow|Control Group 1|At least one location will serve as the control office and will continue to conduct their visits including screening for cognitive impairment as they normally do using their usual method based on the primary care provider's normal practice.
11349739|NCT04063371|FG001|Participant Flow|Intervention Group|"At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.~Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE): The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.~Informant Conversation: If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year."
11349740|NCT04063371|FG002|Participant Flow|Control Group 2|Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
11349741|NCT04063371|OG000|Outcome|Control Group 1|At least one location will serve as the control office and will continue to conduct their visits including screening for cognitive impairment as they normally do using their usual method based on the primary care provider's normal practice.
11349742|NCT04063371|OG001|Outcome|Intervention Group|"At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.~Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE): The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.~Informant Conversation: If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year."
11349743|NCT04063371|OG002|Outcome|Control Group 2|Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
11349744|NCT04063371|OG000|Outcome|Intervention Group|"At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.~Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE): The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.~Informant Conversation: If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year."
11349745|NCT04063371|OG000|Outcome|Providers|The providers from the intervention group were asked to complete a questionnaire to evaluate the practicality and ease of use of the SAGE and eSAGE test.
11349746|NCT04063371|EG000|Reported Event|Control Group 1|At least one location will serve as the control office and will continue to conduct their visits including screening for cognitive impairment as they normally do using their usual method based on the primary care provider's normal practice.
11349747|NCT04063371|EG001|Reported Event|Intervention Group|"At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.~Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE): The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.~Informant Conversation: If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year."
11349748|NCT04063371|EG002|Reported Event|Control Group 2|Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.
11349749|NCT04042324|BG000|Baseline|Safety Population|All patients enrolled in the study.
11349750|NCT04042324|FG000|Participant Flow|UFH and Triferic Admixture (Day 1)|"Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer heparin line. This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis."
11349751|NCT04042324|FG001|Participant Flow|Triferic Post-dialyzer; UFH Via Continuous Infusion (Day 3)|Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.
11349752|NCT04042324|FG002|Participant Flow|UFH Via Continuous Infusion Pre-dialyzer (Day 5)|Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis
11229004|NCT02394925|FG000|Participant Flow|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
11229005|NCT02394925|OG000|Outcome|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
11229006|NCT02394925|EG000|Reported Event|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
11229007|NCT02394951|BG000|Baseline|Pregabalin First Then Placebo|"Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.~Pregabalin: Anticonvulsant~Placebo: Identical, matching inactive substance"
11229008|NCT02394951|BG001|Baseline|Placebo First Then Pregabalin|"Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.~Pregabalin: Anticonvulsant~Placebo: Identical, matching inactive substance"
11229009|NCT02394951|BG002|Baseline|Total|Total of all reporting groups
11229010|NCT02394951|FG000|Participant Flow|Pregabalin First Then Placebo|"Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.~Pregabalin: Anticonvulsant~Placebo: Identical, matching inactive substance"
11229011|NCT02394951|FG001|Participant Flow|Placebo First Then Pregabalin|"Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.~Pregabalin: Anticonvulsant~Placebo: Identical, matching inactive substance"
11229012|NCT02394951|OG000|Outcome|Pregabalin|"Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.~Pregabalin: Anticonvulsant~Placebo: Identical, matching inactive substance"
11229013|NCT02394951|OG001|Outcome|Placebo|"Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.~Pregabalin: Anticonvulsant~Placebo: Identical, matching inactive substance"
11229014|NCT02394951|EG000|Reported Event|Pregabalin|"Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.~Pregabalin: Anticonvulsant~Placebo: Identical, matching inactive substance"
11229015|NCT02394951|EG001|Reported Event|Placebo|"Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.~Pregabalin: Anticonvulsant~Placebo: Identical, matching inactive substance"
11229016|NCT02395042|BG000|Baseline|LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.
11229017|NCT02395042|BG001|Baseline|LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)|Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
11229018|NCT02395042|BG002|Baseline|LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
11229019|NCT02395042|BG003|Baseline|Total|Total of all reporting groups
11229020|NCT02395042|FG000|Participant Flow|LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.
11229021|NCT02395042|FG001|Participant Flow|LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)|Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
11229022|NCT02395042|FG002|Participant Flow|LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
11229023|NCT02395042|OG000|Outcome|LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.
11229024|NCT02395042|OG001|Outcome|LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)|Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
11349753|NCT04042324|OG000|Outcome|UFH and Triferic Admixture|"Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer heparin line. This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.~Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.~Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments."
11349754|NCT04042324|OG001|Outcome|UFH Via Continuous Infusion Pre-dialyzer|"Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis~Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments."
11349755|NCT04042324|OG000|Outcome|Triferic Post-dialyzer; UFH Via Continuous Infusion|"Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.~Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.~Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments."
11349756|NCT04042324|OG001|Outcome|UFH and Triferic Admixture|"Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer heparin line. This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.~Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.~Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments."
11349757|NCT04042324|OG002|Outcome|UFH Via Continuous Infusion Pre-dialyzer|"Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis~Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments."
11349758|NCT04042324|EG000|Reported Event|Triferic Post-dialyzer; UFH Via Continuous Infusion|"Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.~Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.~Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments."
11349759|NCT04042324|EG001|Reported Event|UFH and Triferic Admixture|"Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer heparin line. This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.~Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.~Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments."
11349760|NCT04042324|EG002|Reported Event|UFH Via Continuous Infusion Pre-dialyzer|"Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis~Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments."
11229025|NCT02395042|OG002|Outcome|LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
11229026|NCT02395042|EG000|Reported Event|LiRIS Placebo, LiRIS Placebo (Tx 1)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Adverse events (AEs) reported in Tx 1.
11229027|NCT02395042|EG001|Reported Event|LiRIS®, LiRIS® (Tx 1)|Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. AEs reported in Tx 1.
11229028|NCT02395042|EG002|Reported Event|LiRIS Placebo, LiRIS® (Tx 1)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. AEs reported in Tx 1.
11229029|NCT02395042|EG003|Reported Event|LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. AEs reported in Tx 2.
11229030|NCT02395042|EG004|Reported Event|LiRIS®, LiRIS® /LiRIS® (Tx 2)|Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14. AEs reported in Tx 2.
11229031|NCT02395042|EG005|Reported Event|LiRIS Placebo, LiRIS /LiRIS® (Tx 2)|Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14. AEs reported in Tx 2.
11229032|NCT02395055|BG000|Baseline|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
11229033|NCT02395055|BG001|Baseline|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
11229034|NCT02395055|BG002|Baseline|Total|Total of all reporting groups
11229035|NCT02395055|FG000|Participant Flow|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
11229036|NCT02395055|FG001|Participant Flow|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
11229037|NCT02395055|OG000|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
11229038|NCT02395055|OG001|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
11229039|NCT02395055|EG000|Reported Event|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
11229040|NCT02395055|EG001|Reported Event|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
11229041|NCT02395081|BG000|Baseline|600 IU|"Women will receive prenatal vitamins containing 600 IU of Vitamin D.~Dietary supplement: 600 IU Vitamin D3 in prenatal vitamin"
11229042|NCT02395081|BG001|Baseline|2000 IU|"Women will receive prenatal vitamins containing 2000 IU of Vitamin D.~Dietary supplement: 2000 IU Vitamin D in prenatal vitamin"
11229043|NCT02395081|BG002|Baseline|4000 IU|"Women will receive prenatal vitamins containing 4000 IU of Vitamin D.~Dietary supplement: 4000 IU Vitamin D3 in prenatal vitamin"
11229044|NCT02395081|BG003|Baseline|Total|Total of all reporting groups
11229045|NCT02395081|FG000|Participant Flow|600 IU|"Women will receive prenatal vitamins containing 600 IU of Vitamin D.~Dietary supplement: 600 IU Vitamin D3 in prenatal vitamin"
11229046|NCT02395081|FG001|Participant Flow|2000 IU|"Women will receive prenatal vitamins containing 2000 IU of Vitamin D.~Dietary supplement: 2000 IU Vitamin D in prenatal vitamin"
11229047|NCT02395081|FG002|Participant Flow|4000 IU|"Women will receive prenatal vitamins containing 4000 IU of Vitamin D.~Dietary supplement: 4000 IU Vitamin D3 in prenatal vitamin"
11229048|NCT02395081|OG000|Outcome|600 IU|"Women will receive prenatal vitamins containing 600 IU of Vitamin D.~Dietary supplement: 600 IU Vitamin D3 in prenatal vitamin"
11229049|NCT02395081|OG001|Outcome|2000 IU|"Women will receive prenatal vitamins containing 2000 IU of Vitamin D.~Dietary supplement: 2000 IU Vitamin D in prenatal vitamin"
11229050|NCT02395081|OG002|Outcome|4000 IU|"Women will receive prenatal vitamins containing 4000 IU of Vitamin D.~Dietary supplement: 4000 IU Vitamin D3 in prenatal vitamin"
11229051|NCT02395081|OG000|Outcome|600 IU|"Women will receive prenatal vitamins containing 600 IU of Vitamin D.~600 IU Vitamin D3 in prenatal vitamin: Women will receive 600 IU 25(OH)D in prenatal vitamin."
11229052|NCT02395081|OG001|Outcome|2000 IU|"Women will receive prenatal vitamins containing 2000 IU of Vitamin D.~2000 IU Vitamin D3 in prenatal vitamin: Women will receive 2000 IU 25(OH)D in prenatal vitamin."
11229053|NCT02395081|OG002|Outcome|4000 IU|"Women will receive prenatal vitamins containing 4000 IU of Vitamin D.~4000 IU Vitamin D3 in prenatal vitamin: Women will receive 4000 IU 25(OH)D in prenatal vitamin."
11229054|NCT02395081|EG000|Reported Event|600 IU|"Women will receive prenatal vitamins containing 600 IU of Vitamin D.~Dietary supplement: 600 IU Vitamin D3 in prenatal vitamin"
11229055|NCT02395081|EG001|Reported Event|2000 IU|"Women will receive prenatal vitamins containing 2000 IU of Vitamin D.~Dietary supplement: 2000 IU Vitamin D in prenatal vitamin"
11166124|NCT01972516|EG000|Reported Event|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
11166125|NCT01972516|EG001|Reported Event|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
11166126|NCT01972529|BG000|Baseline|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166127|NCT01972529|BG001|Baseline|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166128|NCT01972529|BG002|Baseline|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166129|NCT01972529|BG003|Baseline|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166130|NCT01972529|BG004|Baseline|Total|Total of all reporting groups
11166131|NCT01972529|FG000|Participant Flow|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) (60 mg total) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166132|NCT01972529|FG001|Participant Flow|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the elective procedure.
11166133|NCT01972529|FG002|Participant Flow|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166134|NCT01972529|FG003|Participant Flow|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166135|NCT01972529|OG000|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L ) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166136|NCT01972529|OG001|Outcome|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166137|NCT01972529|OG002|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166138|NCT01972529|OG003|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166139|NCT01972529|OG000|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166140|NCT01972529|EG000|Reported Event|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166141|NCT01972529|EG001|Reported Event|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11166142|NCT01972529|EG002|Reported Event|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11229056|NCT02395081|EG002|Reported Event|4000 IU|"Women will receive prenatal vitamins containing 4000 IU of Vitamin D.~Dietary supplement: 4000 IU Vitamin D3 in prenatal vitamin"
11349761|NCT04071392|BG000|Baseline|Post-Essure Group|"Healthy women with history of Essure hysteroscopic permanent contraception.~Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.~Hysterosalpingogram (HSG): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency."
11349762|NCT04071392|BG001|Baseline|Control Group|"Healthy women with no history of permanent contraception.~Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.~Hysterosalpingogram (HSG): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency."
11349763|NCT04071392|BG002|Baseline|Total|Total of all reporting groups
11349764|NCT04071392|FG000|Participant Flow|Post-Essure Group|"Healthy women with history of Essure hysteroscopic permanent contraception.~Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.~Hysterosalpingogram (HSG): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency."
11349765|NCT04071392|FG001|Participant Flow|Control Group|"Healthy women with no history of permanent contraception.~Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.~Hysterosalpingogram (HSG): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency."
11349766|NCT04071392|OG000|Outcome|Post-Essure Group|"Healthy women with history of Essure hysteroscopic permanent contraception.~Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.~Hysterosalpingogram (HSG): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency."
11349767|NCT04071392|OG001|Outcome|Control Group|"Healthy women with no history of permanent contraception.~Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.~Hysterosalpingogram (HSG): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency."
11349768|NCT04071392|EG000|Reported Event|Post-Essure Group|"Healthy women with history of Essure hysteroscopic permanent contraception.~Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.~Hysterosalpingogram (HSG): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency."
11349769|NCT04071392|EG001|Reported Event|Control Group|"Healthy women with no history of permanent contraception.~Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.~Hysterosalpingogram (HSG): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency."
11349770|NCT04071301|BG000|Baseline|Investigational Device|TENA SmartCare Urine Sensor and Gateway
11349771|NCT04071301|FG000|Participant Flow|Investigational Device|"TENA SmartCare Urine Sensor and Gateway~Each participating subject was provided with Urine Sensor and absorbent products for the duration of the investigation. Seven types of absorbent products were used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject was allocated to the type(s) that were considered most suitable.~Gateways were placed in the resident's rooms as well as in common areas to enable full measurement registration."
11349772|NCT04071301|OG000|Outcome|Investigational Device|TENA SmartCare Urine Sensor and Gateway
11349773|NCT04071301|EG000|Reported Event|Investigational Device|"TENA SmartCare Urine Sensor and Gateway~."
11349774|NCT04071158|BG000|Baseline|RSV Vaccine 120 mcg With Placebo|Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.
11349775|NCT04071158|BG001|Baseline|RSV Vaccine 120 mcg With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349776|NCT04071158|BG002|Baseline|RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.
10887802|NCT00502801|EG000|Reported Event|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
11166143|NCT01972529|EG003|Reported Event|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
11349777|NCT04071158|BG003|Baseline|RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349778|NCT04071158|BG004|Baseline|Placebo/Tdap|Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349779|NCT04071158|BG005|Baseline|Total|Total of all reporting groups
11349780|NCT04071158|FG000|Participant Flow|Respiratory Syncytial Virus (RSV) Vaccine 120 Microgram (mcg) With Placebo|Participants received 0.5 milliliter (mL), intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.
11349781|NCT04071158|FG001|Participant Flow|RSV Vaccine 120 mcg With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) on Day 1. Participants were followed up to 1 month after vaccination.
11349782|NCT04071158|FG002|Participant Flow|RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.
11349783|NCT04071158|FG003|Participant Flow|RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349784|NCT04071158|FG004|Participant Flow|Placebo/Tdap|Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349785|NCT04071158|OG000|Outcome|RSV Vaccine With Aluminum Hydroxide With Tdap|This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349786|NCT04071158|OG001|Outcome|Placebo/Tdap|Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349787|NCT04071158|OG001|Outcome|RSV Vaccine With Aluminum Hydroxide With Placebo|This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo or RSV vaccine 240 mcg with aluminum hydroxide with matching placebo on Day 1. Participants were followed up to 1 month after vaccination.
11349788|NCT04071158|OG000|Outcome|RSV Vaccine 120 mcg With Placebo|Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.
11349789|NCT04071158|OG001|Outcome|RSV Vaccine 120 mcg With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349790|NCT04071158|OG002|Outcome|RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.
11349791|NCT04071158|OG003|Outcome|RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349792|NCT04071158|OG004|Outcome|Placebo/Tdap|Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349793|NCT04071158|OG000|Outcome|RSV Vaccine 120 mcg With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349794|NCT04071158|OG001|Outcome|RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349795|NCT04071158|OG002|Outcome|Placebo/Tdap|Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349796|NCT04071158|EG000|Reported Event|RSV Vaccine 120 mcg With Placebo|Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.
11349797|NCT04071158|EG001|Reported Event|RSV Vaccine 120 mcg With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349798|NCT04071158|EG002|Reported Event|RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.
11349799|NCT04071158|EG003|Reported Event|RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap|Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11349800|NCT04071158|EG004|Reported Event|Placebo/Tdap|Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
11229057|NCT02395133|BG000|Baseline|Placebo QW|Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
11229058|NCT02395133|BG001|Baseline|Dupilumab 300 mg Q8W|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
11229059|NCT02395133|BG002|Baseline|Dupilumab 300 mg Q4W|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
11229060|NCT02395133|BG003|Baseline|Dupilumab 300 mg Q2W/QW|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
11229061|NCT02395133|BG004|Baseline|Total|Total of all reporting groups
11229062|NCT02395133|FG000|Participant Flow|Placebo QW|Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
11229063|NCT02395133|FG001|Participant Flow|Dupilumab 300 mg Q8W|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
11229064|NCT02395133|FG002|Participant Flow|Dupilumab 300 mg Q4W|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
11229065|NCT02395133|FG003|Participant Flow|Dupilumab 300 mg Q2W/QW|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
11229066|NCT02395133|OG000|Outcome|Placebo QW|Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
11229067|NCT02395133|OG001|Outcome|Dupilumab 300 mg Q8W|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
11229068|NCT02395133|OG002|Outcome|Dupilumab 300 mg Q4W|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
11229069|NCT02395133|OG003|Outcome|Dupilumab 300 mg Q2W/QW|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
11229070|NCT02395133|EG000|Reported Event|Placebo QW|Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36.
11229071|NCT02395133|EG001|Reported Event|Dupilumab 300 mg Q8W|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36.
11229072|NCT02395133|EG002|Reported Event|Dupilumab 300 mg Q4W|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36.
11229073|NCT02395133|EG003|Reported Event|Dupilumab 300 mg Q2W/QW|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
11229074|NCT02395172|BG000|Baseline|Avelumab|Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
11229075|NCT02395172|BG001|Baseline|Docetaxel|Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
11229076|NCT02395172|BG002|Baseline|Total|Total of all reporting groups
11229077|NCT02395172|FG000|Participant Flow|Avelumab|Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
11229078|NCT02395172|FG001|Participant Flow|Docetaxel|Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
11229079|NCT02395172|OG000|Outcome|Avelumab|Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
11229080|NCT02395172|OG001|Outcome|Docetaxel|Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
11229081|NCT02395172|EG000|Reported Event|Avelumab|Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
11229082|NCT02395172|EG001|Reported Event|Docetaxel|Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
11229083|NCT02395185|BG000|Baseline|All Participants|"Bottle Administration: 2 oz of sucrose, water, or milk/formula given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
11229084|NCT02395185|FG000|Participant Flow|All Participants|33 Participants were randomized to one of 18 sequences of milk, water, or formula for an average of 6 casting visits.
11349801|NCT04070287|BG000|Baseline|SMART Pack|"This involves using SMART Pack a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers.~SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state."
11349802|NCT04070287|BG001|Baseline|Luv Box|"The intervention involves using Luv Box a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people.~Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the Luv Box and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state."
11349803|NCT04070287|BG002|Baseline|Bili Vibes|"The intervention involves using a program program called Bili that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people.~Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state."
11349804|NCT04070287|BG003|Baseline|BeterDoc|"This intervention involve using BeterDoc Safety kits that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people.~BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the BeterDoc Safety Kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state."
11349805|NCT04070287|BG004|Baseline|IUNGO|"This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people.~IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state."
11349806|NCT04070287|BG005|Baseline|Total|Total of all reporting groups
11349807|NCT04070287|FG000|Participant Flow|SMART Pack|"This involves using SMART Pack a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers.~SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state."
11349808|NCT04070287|FG001|Participant Flow|Luv Box|"The intervention involves using Luv Box a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people.~Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the Luv Box and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state."
11349809|NCT04070287|FG002|Participant Flow|Bili Vibes|"The intervention involves using a program program called Bili that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people.~Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state."
11349810|NCT04070287|FG003|Participant Flow|BeterDoc|"This intervention involve using BeterDoc Safety kits that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people.~BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the BeterDoc Safety Kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state."
11349811|NCT04070287|FG004|Participant Flow|IUNGO|"This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people.~IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state."
11166144|NCT01972568|BG000|Baseline|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
11166145|NCT01972568|BG001|Baseline|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
11166146|NCT01972568|BG002|Baseline|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
11166147|NCT01972568|BG003|Baseline|Total|Total of all reporting groups
11166148|NCT01972568|FG000|Participant Flow|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
11166149|NCT01972568|FG001|Participant Flow|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
11166150|NCT01972568|FG002|Participant Flow|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
11166151|NCT01972568|OG000|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
11166152|NCT01972568|OG001|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
11166153|NCT01972568|OG002|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
11166154|NCT01972568|EG000|Reported Event|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
11166155|NCT01972568|EG001|Reported Event|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
11166156|NCT01972568|EG002|Reported Event|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
11166157|NCT01972659|BG000|Baseline|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
11166158|NCT01972659|BG001|Baseline|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
11166159|NCT01972659|BG002|Baseline|Total|Total of all reporting groups
11166160|NCT01972659|FG000|Participant Flow|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
11166161|NCT01972659|FG001|Participant Flow|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
11166162|NCT01972659|OG000|Outcome|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
11166163|NCT01972659|OG001|Outcome|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
11166164|NCT01972659|EG000|Reported Event|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
11166165|NCT01972659|EG001|Reported Event|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
11166166|NCT01972724|BG000|Baseline|Pioglitazone 15 mg (Double-Blind)|Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166167|NCT01972724|BG001|Baseline|Pioglitazone 30 mg (Double-Blind)|Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166168|NCT01972724|BG002|Baseline|Pioglitazone 30 mg (Open-Label)|Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166169|NCT01972724|BG003|Baseline|Total|Total of all reporting groups
11166170|NCT01972724|FG000|Participant Flow|Pioglitazone 15 mg (Double-Blind)|Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166171|NCT01972724|FG001|Participant Flow|Pioglitazone 30 mg (Double-Blind)|Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166172|NCT01972724|FG002|Participant Flow|Pioglitazone 30 mg (Open-Label)|Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166173|NCT01972724|OG000|Outcome|Pioglitazone 15 mg (Double-Blind)|Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166174|NCT01972724|OG001|Outcome|Pioglitazone 30 mg (Double-Blind)|Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11349812|NCT04070287|OG000|Outcome|SMART Pack|"This involves using SMART Pack a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers.~SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state."
11349813|NCT04070287|OG001|Outcome|Luv Box|"The intervention involves using Luv Box a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people.~Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the Luv Box and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state."
11349814|NCT04070287|OG002|Outcome|Bili Vibes|"The intervention involves using a program program called Bili that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people.~Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state."
11349815|NCT04070287|OG003|Outcome|BeterDoc|"This intervention involve using BeterDoc Safety kits that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people.~BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the BeterDoc Safety Kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state."
11349816|NCT04070287|OG004|Outcome|IUNGO|"This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people.~IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state."
11349817|NCT04070287|EG000|Reported Event|SMART Pack|"This involves using SMART Pack a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers.~SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state."
11349818|NCT04070287|EG001|Reported Event|Luv Box|"The intervention involves using Luv Box a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people.~Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the Luv Box and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state."
11349819|NCT04070287|EG002|Reported Event|Bili Vibes|"The intervention involves using a program program called Bili that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people.~Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state."
11089344|NCT01523457|OG001|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
11349820|NCT04070287|EG003|Reported Event|BeterDoc|"This intervention involve using BeterDoc Safety kits that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people.~BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the BeterDoc Safety Kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state."
11349821|NCT04070287|EG004|Reported Event|IUNGO|"This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people.~IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state."
11349822|NCT04069715|BG000|Baseline|Farlong NotoGinseng™|Farlong NotoGinseng™ (Treatment Group)
11349823|NCT04069715|BG001|Baseline|Placebo|Placebo Group
11349824|NCT04069715|BG002|Baseline|Total|Total of all reporting groups
11349825|NCT04069715|FG000|Participant Flow|Farlong NotoGinseng™|Farlong NotoGinseng™ (Treatment Group)
11349826|NCT04069715|FG001|Participant Flow|Placebo|Placebo Group
11349827|NCT04069715|OG000|Outcome|Farlong NotoGinseng™|Farlong NotoGinseng™ (Treatment Group)
11349828|NCT04069715|OG001|Outcome|Placebo|Placebo Group
11349829|NCT04069715|EG000|Reported Event|Farlong NotoGinseng™|Farlong NotoGinseng™ (Treatment Group)
11349830|NCT04069715|EG001|Reported Event|Placebo|Placebo Group
11349831|NCT04050722|BG000|Baseline|Sensodyne Repair and Protect (Test Dentifrice)|Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
11349832|NCT04050722|BG001|Baseline|Colgate Cavity Protection (Negative Control Dentifrice)|Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
11349833|NCT04050722|BG002|Baseline|Total|Total of all reporting groups
11349834|NCT04050722|FG000|Participant Flow|Sensodyne Repair and Protect (Test Dentifrice)|Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 percent (%) stannous fluoride (SnF2) (1100 parts per million [ppm] fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
11349835|NCT04050722|FG001|Participant Flow|Colgate Cavity Protection (Negative Control Dentifrice)|Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as sodium monofluorophosphate (SMFP) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
11166175|NCT01972724|OG002|Outcome|Pioglitazone 30 mg (Open-Label)|Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11349836|NCT04050722|OG000|Outcome|Sensodyne Repair and Protect (Test Dentifrice)|Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
11349837|NCT04050722|OG001|Outcome|Colgate Cavity Protection (Negative Control Dentifrice)|Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
11349838|NCT04050722|EG000|Reported Event|Sensodyne Repair and Protect (Test Dentifrice)|Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
11349839|NCT04050722|EG001|Reported Event|Colgate Cavity Protection (Negative Control Dentifrice)|Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit.
11349840|NCT04069221|BG000|Baseline|Part 1|open-label study in 8 healthy subjects to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 and co-administration of a single iv infusion of a [14C] OZ439 radiolabeled microdose
11349841|NCT04069221|BG001|Baseline|Part 2|open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment
11349842|NCT04069221|BG002|Baseline|Total|Total of all reporting groups
11349843|NCT04069221|FG000|Participant Flow|Part 1|open-label study in 8 healthy subjects to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 and co-administration of a single iv infusion of a [14C] OZ439 radiolabeled microdose
11349844|NCT04069221|FG001|Participant Flow|Part 2 Treatment B, Then C and D|"open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment~Treatment B: a single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion~Treatment C: a single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion~Treatment D: a single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)"
11349845|NCT04069221|FG002|Participant Flow|Part 2 Treatment C, Then D and B|"open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment~Treatment C: a single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion~Treatment D: a single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)~Treatment B: a single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion"
11349846|NCT04069221|FG003|Participant Flow|Part 2 Treatment D, Then B and C|"open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment~Treatment D: a single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)~Treatment B: a single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion~Treatment C: a single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion"
11349847|NCT04069221|OG000|Outcome|Part 1|"open-label study in 8 healthy subjects to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 and co-administration of a single iv infusion of a [14C] OZ439 radiolabeled microdose at the anticipated tmax of the oral dose.~Treatment A: a single oral dose of 800 mg OZ439 simple granules administered as a 100-mL dispersion followed by a 15-minute 10-mL iv infusion of 100 μg [14C] OZ439 (47 kBq [1.27 µCi]) beginning 3 hours after the oral dose administration."
11349848|NCT04069221|OG000|Outcome|Part 2, Treatment B: Single Oral Dose of 800 mg OZ439|"This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)~Single oral dose of 800 mg OZ439: Single oral dose of 800 mg OZ439"
11349849|NCT04069221|OG001|Outcome|Part 2, Treatment C: Single Oral Dose of 400 mg OZ439|"This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)~Single oral dose of 400 mg OZ439: Single oral dose of 400 mg OZ439"
11349850|NCT04069221|OG002|Outcome|Part 2, Treatment D:Single Oral Dose 400 mg OZ439+Cobicistat|"This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)~Single oral dose of 400 mg OZ439: Single oral dose of 400 mg OZ439~Single oral dose of cobicistat: Single oral dose of 150 mg cobicistat"
11349851|NCT04069221|EG000|Reported Event|Part 1, Single Arm|"This was an open-label study in 8 healthy subjects to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 and co-administration of a single iv infusion of a [14C]-OZ439 radiolabeled microdose at the anticipated Tmax of the oral dose. Subjects received the following treatment:~Treatment A: A single oral dose of 800 mg OZ439 simple granules administered as a 100-mL dispersion followed by a 15-minute 10-mL iv infusion of 100 μg [14C]-OZ439 (47 kBq [1.27 μCi]) beginning 3 hours after the oral dose administration.~Single oral dose of 800 mg OZ439: Single oral dose of 800 mg OZ439~iv infusion of [14C]-OZ439: 15-minute 10-mL iv infusion of 100 μg [14C]-OZ439"
11166176|NCT01972724|EG000|Reported Event|Pioglitazone 15 mg (Double-Blind)|Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166177|NCT01972724|EG001|Reported Event|Pioglitazone 30 mg (Double-Blind)|Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166178|NCT01972724|EG002|Reported Event|Pioglitazone 30 mg (Open-Label)|Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
11166179|NCT01972776|BG000|Baseline|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
11166180|NCT01972776|BG001|Baseline|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
11166181|NCT01972776|BG002|Baseline|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
11166182|NCT01972776|BG003|Baseline|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
11166183|NCT01972776|BG004|Baseline|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
11166184|NCT01972776|BG005|Baseline|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
11166185|NCT01972776|BG006|Baseline|Total|Total of all reporting groups
11166186|NCT01972776|FG000|Participant Flow|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
11166187|NCT01972776|FG001|Participant Flow|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
11166188|NCT01972776|FG002|Participant Flow|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
11166189|NCT01972776|FG003|Participant Flow|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
11166190|NCT01972776|FG004|Participant Flow|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
11166191|NCT01972776|FG005|Participant Flow|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
11166192|NCT01972776|OG000|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
11166193|NCT01972776|OG001|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
11166194|NCT01972776|OG002|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
11166195|NCT01972776|OG003|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
11166196|NCT01972776|OG000|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
11166197|NCT01972776|OG001|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
11166198|NCT01972776|EG000|Reported Event|Part 1: QBM076 B.I.D 25 mg|Part 1: QBM076 B.I.D 25 mg
11166199|NCT01972776|EG001|Reported Event|Part 1: QBM076 B.I.D 75 mg|Part 1: QBM076 B.I.D 75 mg
11166200|NCT01972776|EG002|Reported Event|Part 1: QBM076 B.I.D 150 mg|Part 1: QBM076 B.I.D 150 mg
11166201|NCT01972776|EG003|Reported Event|Part 1: Placebo|Part 1: Placebo
11166202|NCT01972776|EG004|Reported Event|Part 2: QBM076 B.I.D 150 mg|Part 2: QBM076 B.I.D 150 mg
11166203|NCT01972776|EG005|Reported Event|Part 2:QBM076 B.I.D Placebo|Part 2:QBM076 B.I.D Placebo
11166204|NCT01972789|BG000|Baseline|Intensive Retinal Fluid Regimen|Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
11166205|NCT01972789|BG001|Baseline|Relaxed Retinal Fluid Regimen|Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.
11166206|NCT01972789|BG002|Baseline|Total|Total of all reporting groups
11166207|NCT01972789|FG000|Participant Flow|Intensive Retinal Fluid Regimen|Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
11166208|NCT01972789|FG001|Participant Flow|Relaxed Retinal Fluid Regimen|Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.
11166209|NCT01972789|OG000|Outcome|Intensive Retinal Fluid Regimen|Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
11166210|NCT01972789|OG001|Outcome|Relaxed Retinal Fluid Regimen|Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.
11166211|NCT01972789|EG000|Reported Event|Intensive|Intensive
11166212|NCT01972789|EG001|Reported Event|Relaxed|Relaxed
11166213|NCT01972841|BG000|Baseline|Placebo|Participants who received matching placebo once a day for 12 weeks.
11166214|NCT01972841|BG001|Baseline|Mirabegron 25 mg|Participants who received mirabegron 25 mg once a day for 12 weeks.
11166215|NCT01972841|BG002|Baseline|Mirabegron 50 mg|Participants who received mirabegron 50 mg once a day for 12 weeks.
11166216|NCT01972841|BG003|Baseline|Solifenacin 5 mg|Participants who received solifenacin 5 mg once a day for 12 weeks.
11166217|NCT01972841|BG004|Baseline|Solifenacin 5 mg + Mirabegron 25 mg|Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
11166218|NCT01972841|BG005|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
11166219|NCT01972841|BG006|Baseline|Total|Total of all reporting groups
11166220|NCT01972841|FG000|Participant Flow|Placebo|Participants who received matching placebo once a day for 12 weeks.
11166221|NCT01972841|FG001|Participant Flow|Mirabegron 25 mg|Participants who received mirabegron 25 mg once a day for 12 weeks.
11229085|NCT02395185|OG000|Outcome|Milk|"Bottle Administration: 2 oz milk or formula given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
11229086|NCT02395185|OG001|Outcome|Water|"Bottle Administration: 2 oz water given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
11229087|NCT02395185|OG002|Outcome|Sucrose|"Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
11166222|NCT01972841|FG002|Participant Flow|Mirabegron 50 mg|Participants who received mirabegron 50 mg once a day for 12 weeks.
11166223|NCT01972841|FG003|Participant Flow|Solifenacin 5 mg|Participants who received solifenacin 5 mg once a day for 12 weeks.
11166224|NCT01972841|FG004|Participant Flow|Solifenacin 5 mg + Mirabegron 25 mg|Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
11166225|NCT01972841|FG005|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
11166226|NCT01972841|OG000|Outcome|Placebo|Participants who received matching placebo once a day for 12 weeks.
11166227|NCT01972841|OG001|Outcome|Mirabegron 25 mg|Participants who received mirabegron 25 mg once a day for 12 weeks.
11166228|NCT01972841|OG002|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once a day for 12 weeks.
11166229|NCT01972841|OG003|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once a day for 12 weeks.
11166230|NCT01972841|OG004|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
11166231|NCT01972841|OG005|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
11166232|NCT01972841|EG000|Reported Event|Placebo|Participants who received matching placebo once a day for 12 weeks.
11166233|NCT01972841|EG001|Reported Event|Mirabegron 25 mg|Participants who received mirabegron 25 mg once a day for 12 weeks.
11166234|NCT01972841|EG002|Reported Event|Mirabegron 50 mg|Participants who received mirabegron 50 mg once a day for 12 weeks.
11166235|NCT01972841|EG003|Reported Event|Solifenacin 5 mg|Participants who received solifenacin 5 mg once a day for 12 weeks.
11166236|NCT01972841|EG004|Reported Event|Solifenacin 5 mg + Mirabegron 25 mg|Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
11166237|NCT01972841|EG005|Reported Event|Solifenacin 5 mg + Mirabegron 50 mg|Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
11166238|NCT01973036|BG000|Baseline|Oxytocin|"This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.~Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery."
11166239|NCT01973036|BG001|Baseline|Foley Catheter and Oxytocin|"A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned. Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator). If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.~Foley Catheter: Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.~Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuri"
11166240|NCT01973036|BG002|Baseline|Total|Total of all reporting groups
11166241|NCT01973036|FG000|Participant Flow|Oxytocin|"This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.~Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery."
11166242|NCT01973036|FG001|Participant Flow|Foley Catheter and Oxytocin|"Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.~Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery."
11166243|NCT01973036|OG000|Outcome|Oxytocin|"This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.~Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery."
11229088|NCT02395185|EG000|Reported Event|Sucrose|"Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
11229089|NCT02395185|EG001|Reported Event|Milk or Formula|"Bottle Administration: 2 oz milk or formula given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
11229090|NCT02395185|EG002|Reported Event|Water|"Bottle Administration: 2 oz water given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
11229091|NCT02395302|BG000|Baseline|Dual Action Pneumatic Compression|"Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.~Dual Action Pneumatic Compression: Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period."
11229092|NCT02395302|FG000|Participant Flow|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. Subjects that received the dual action pneumatic compression device were instructed to use the device in sustained mode for fourteen hours per day and in intermittent mode for three hours per day during the four week treatment period.
11229093|NCT02395302|OG000|Outcome|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
11229094|NCT02395302|EG000|Reported Event|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
11229095|NCT02395471|BG000|Baseline|Patient Wth Barrett's|"Subjects presenting for routine endoscopic BE surveillance examinations~Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11229096|NCT02395471|BG001|Baseline|Patients With GERD|"Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE~Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11229097|NCT02395471|BG002|Baseline|Total|Total of all reporting groups
11229098|NCT02395471|FG000|Participant Flow|Patient Wth Barrett's|"Subjects presenting for routine endoscopic BE surveillance examinations~Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11229099|NCT02395471|FG001|Participant Flow|Patients With GERD|"Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE~Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11229100|NCT02395471|OG000|Outcome|Study Participant Cytosponge Procedure Acceptability|Acceptability of the Cytosponge Procedure by all study subjects that underwent both Cytosponge and Endoscopy
11229101|NCT02395471|OG000|Outcome|Patient Wth Barrett's|"Subjects presenting for routine endoscopic BE surveillance examinations~Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11229102|NCT02395471|OG001|Outcome|Patients With GERD|"Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE~Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11229103|NCT02395471|OG000|Outcome|Operating Characteristics of Cytosponge™/TFF3 vs BE Diagnosis|Sensitivity, Specificity, PPV, NPV, and Accuracy of Cytosponge™/TFF3 vs. the Gold Standard of Endoscopy for BE Diagnosis
11229104|NCT02395471|OG000|Outcome|Cytosponge™ Operating Characteristics vs Worst Histology|The second secondary objective was to assess the operating characteristics of Cytosponge™ against the worst ever histology documented in the subject.
11229105|NCT02395471|OG000|Outcome|Non-Dysplastic BE|Non-Dysplastic BE
11229106|NCT02395471|OG001|Outcome|Indefinite for Dysplasia|Indefinite for Dysplasia
11229107|NCT02395471|OG002|Outcome|Low Grade Dysplasia|Low Grade Dysplasia
11229108|NCT02395471|OG003|Outcome|High Grade Dysplasia|High Grade Dysplasia
11229109|NCT02395471|OG000|Outcome|Incidence|Incidence of Abrasion, Bleeding and Perforation observed via Endoscopy
11229110|NCT02395471|OG000|Outcome|Incidence of AE's|Incidence of AE's
11229111|NCT02395471|EG000|Reported Event|Patient Wth Barrett's|"Subjects presenting for routine endoscopic BE surveillance examinations who had at least a C1 or M3 segment confirmed (or medically suspected).~Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11229112|NCT02395471|EG001|Reported Event|Patients With GERD|"Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing screening for BE~Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11229113|NCT02395536|BG000|Baseline|In Office Outside Walls of Hospital|"Reveal LINQ insertions will be performed in office setting.~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
11229114|NCT02395536|BG001|Baseline|Traditional Hospital Setting|"Reveal LINQ insertions will be performed in IN-a traditional setting~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
11229115|NCT02395536|BG002|Baseline|Total|Total of all reporting groups
11349852|NCT04069221|EG001|Reported Event|Part 2, Treatment B: Single Oral Dose of 800 mg OZ439|This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)
11349853|NCT04069221|EG002|Reported Event|Part 2, Treatment C: Single Oral Dose of 400 mg OZ439|This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)
11349854|NCT04069221|EG003|Reported Event|Part 2, Treatment D:Single Oral Dose 400 mg OZ439+Cobicistat|This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor)
11349855|NCT04067141|BG000|Baseline|Overall Study|Subjects were randomized to wear somofilcon A 1 day and nelfilcon A for one week in this cross-over study.
11349856|NCT04067141|FG000|Participant Flow|Somofilcon A, Then Nelfilcon A|"Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.~somofilcon A: Contact Lens~nelfilcon A: Contact Lens"
11349857|NCT04067141|FG001|Participant Flow|Nelfilcon A, Then Somofilcon A|"Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.~somofilcon A: Contact Lens~nelfilcon A: Contact Lens"
11349858|NCT04067141|OG000|Outcome|Somofilcon A|"Subjects will bilaterally wear the somofilcon A lenses for 1 week.~somofilcon A: Contact Lens"
11349859|NCT04067141|OG001|Outcome|Nelfilcon A|"Subjects will bilaterally wear the nelfilcon A lenses for 1 week.~nelfilcon A: Contact Lens"
11349860|NCT04067141|EG000|Reported Event|Somofilcon A|"Subjects will bilaterally wear the somofilcon A lenses for 1 week.~somofilcon A: Contact Lens"
11349861|NCT04067141|EG001|Reported Event|Nelfilcon A|"Subjects will bilaterally wear the nelfilcon A lenses for 1 week.~nelfilcon A: Contact Lens"
11349862|NCT04049578|BG000|Baseline|Balovaptan|Participants were to receive an oral dose of balovaptan once a day (QD) for a 6-week treatment period, followed by an optional extension period of 48 weeks.
11349863|NCT04049578|FG000|Participant Flow|Balovaptan|Participants were to receive an oral dose of balovaptan once a day (QD) for a 6-week treatment period, followed by an optional extension period of 48 weeks.
11349864|NCT04049578|OG000|Outcome|Balovaptan|Participants were to receive an oral dose of balovaptan once a day (QD) for a 6-week treatment period, followed by an optional extension period of 48 weeks.
11349865|NCT04049578|EG000|Reported Event|Balovaptan|Participants were to receive an oral dose of balovaptan once a day (QD) for a 6-week treatment period, followed by an optional extension period of 48 weeks.
11349866|NCT04067401|BG000|Baseline|Wingman Connect|"Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later).~Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills."
11349867|NCT04067401|BG001|Baseline|Stress Management|"The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress.~Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills."
11349868|NCT04067401|BG002|Baseline|Total|Total of all reporting groups
11349869|NCT04067401|FG000|Participant Flow|Wingman Connect|"Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later).~Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills."
11349870|NCT04067401|FG001|Participant Flow|Stress Management|"The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress.~Stress Management: training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; how cognition influences stress responses; common cognitive distortions/attributions that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills."
11349871|NCT04067401|OG000|Outcome|Wingman Connect|"Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later).~Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills."
11349872|NCT04067401|OG001|Outcome|Stress Management|"The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress.~Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills."
11349873|NCT04067401|EG000|Reported Event|Wingman Connect|"Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later).~Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills."
11349874|NCT04067401|EG001|Reported Event|Stress Management|"The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress.~Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cogn"
11349875|NCT04067050|BG000|Baseline|Comfilcon A Asphere|Subjects were randomized to use the study contact lenses for two months.
11349876|NCT04067050|BG001|Baseline|Habitual Spectacles|Subjects were randomized to wear habitual spectacles for two months.
11349877|NCT04067050|BG002|Baseline|Total|Total of all reporting groups
11349878|NCT04067050|FG000|Participant Flow|Comfilcon A Asphere|"Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week.~comfilcon A asphere: Contact Lens"
11349879|NCT04067050|FG001|Participant Flow|Habitual Spectacles|"Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week.~Spectacles: Habitual spectacles"
11349880|NCT04067050|OG000|Outcome|Comfilcon A Asphere|"Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week.~comfilcon A asphere: Contact Lens"
11349881|NCT04067050|OG001|Outcome|Habitual Spectacles|"Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week.~Spectacles: Habitual spectacles"
11349882|NCT04067050|EG000|Reported Event|Comfilcon A Asphere|"Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week.~comfilcon A asphere: Contact Lens"
11349883|NCT04067050|EG001|Reported Event|Habitual Spectacles|"Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week.~Spectacles: Habitual spectacles"
11349884|NCT04066647|BG000|Baseline|Dexamethesone|"Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection.~Dexamethasone 4mg: 1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 60 minutes after injection."
11349885|NCT04066647|FG000|Participant Flow|Dexamthesone|"Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection.~Dexamethasone 4mg: 1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection."
11349886|NCT04066647|OG000|Outcome|Dexamethesone|"Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection.~Dexamethasone 4mg: 1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection."
11229116|NCT02395536|FG000|Participant Flow|In Office Outside Walls of Hospital|"Reveal LINQ insertions will be performed in office setting.~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
11229117|NCT02395536|FG001|Participant Flow|Traditional Hospital Setting|"Reveal LINQ insertions will be performed in IN-a traditional setting~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
11229118|NCT02395536|OG000|Outcome|In Office Outside Walls of Hospital|"Reveal LINQ insertions will be performed in office setting.~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
11229119|NCT02395536|OG001|Outcome|Traditional Hospital Setting|"Reveal LINQ insertions will be performed in IN-a traditional setting~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
11229120|NCT02395536|EG000|Reported Event|In Office Outside Walls of Hospital|"Reveal LINQ insertions will be performed in office setting.~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
11229121|NCT02395536|EG001|Reported Event|Traditional Hospital Setting|"Reveal LINQ insertions will be performed in IN-a traditional setting~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
11229122|NCT02395627|BG000|Baseline|Pembrolizumab Group A|"Estrogen Receptor Positive (ER+) participants~Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1)~Group A Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)"
11229123|NCT02395627|BG001|Baseline|Pembrolizumab Group B|"Estrogen Receptor Positive (ER+) participants~Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1)~Group B Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 2)"
11229124|NCT02395627|BG002|Baseline|Pembrolizumab Group C|"Estrogen Receptor Negative (ER-) participants~Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)"
11229125|NCT02395627|BG003|Baseline|Total|Total of all reporting groups
11229126|NCT02395627|FG000|Participant Flow|Pembrolizumab Cycle 1 (Group A)|"Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)~Tamoxifen~Vorinostat~Pembrolizumab"
11229127|NCT02395627|FG001|Participant Flow|Pembrolizumab Cycle 2 (Group B)|"Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 2)~Tamoxifen~Vorinostat~Pembrolizumab"
11229128|NCT02395627|FG002|Participant Flow|Pembrolizumab Cycle 1 (Group C)|"Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)~Vorinostat~Pembrolizumab"
11229129|NCT02395627|OG000|Outcome|Pembrolizumab Group A|"Estrogen Receptor Positive (ER+) participants~Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1)~Group A Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)"
11229130|NCT02395627|OG001|Outcome|Pembrolizumab: Group B|"Estrogen Receptor Positive (ER+) participants~Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1)~Group B Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 2)"
11229131|NCT02395627|OG002|Outcome|Pembrolizumab Group C|"Estrogen Receptor Negative (ER-) participants~Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)"
11229132|NCT02395627|OG001|Outcome|Pembrolizumab Group B|"Estrogen Receptor Positive (ER+) participants~Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1)~Group A Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 2)"
11229133|NCT02395627|OG001|Outcome|Pembrolizumab Group B|"Estrogen Receptor Positive (ER+) participants~Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1)~Group B Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 2)"
11229134|NCT02395627|EG000|Reported Event|Pembrolizumab Group A|"Estrogen Receptor Positive participants (ER+)~Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Group A: Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)"
11229135|NCT02395627|EG001|Reported Event|Pembrolizumab Group B|"Estrogen Receptor Positive participants (ER+)~Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Group B: Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 2)"
11229136|NCT02395627|EG002|Reported Event|Pembrolizumab Group C|"Estrogen Receptor Negative participants (ER-)~Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)"
11229137|NCT02395653|BG000|Baseline|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
11229138|NCT02395653|FG000|Participant Flow|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
11229139|NCT02395653|OG000|Outcome|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
11166244|NCT01973036|OG001|Outcome|Foley Catheter and Oxytocin|"Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.~Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery."
11166245|NCT01973036|OG001|Outcome|Foley Catheter and Oxytocin|"A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned. Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator). If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.~Foley Catheter: Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.~Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuri"
11166246|NCT01973036|EG000|Reported Event|Oxytocin|"This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.~Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery."
11166247|NCT01973036|EG001|Reported Event|Foley Catheter and Oxytocin|"A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned. Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator). If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.~Foley Catheter: Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.~Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuri"
11166248|NCT01973205|BG000|Baseline|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
11166249|NCT01973205|BG001|Baseline|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
11166250|NCT01973205|BG002|Baseline|Total|Total of all reporting groups
11166251|NCT01973205|FG000|Participant Flow|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
11166252|NCT01973205|FG001|Participant Flow|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
11166253|NCT01973205|OG000|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
11166254|NCT01973205|OG001|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
11166255|NCT01973205|EG000|Reported Event|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
11166256|NCT01973205|EG001|Reported Event|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
11166257|NCT01973218|BG000|Baseline|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
11166258|NCT01973218|BG001|Baseline|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
11166259|NCT01973218|BG002|Baseline|Total|Total of all reporting groups
11166260|NCT01973218|FG000|Participant Flow|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
11166261|NCT01973218|FG001|Participant Flow|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
11166262|NCT01973218|OG000|Outcome|rMenb|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
11166263|NCT01973218|OG001|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
11166264|NCT01973218|OG000|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
11166265|NCT01973218|EG000|Reported Event|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
11166266|NCT01973218|EG001|Reported Event|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
11166267|NCT01973218|EG002|Reported Event|Total|Total of subjects
11349887|NCT04066647|EG000|Reported Event|Dexamethesone|"Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection.~Dexamethasone 4mg: 1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 60 minutes after injection."
11349888|NCT04066426|BG000|Baseline|Naproxen Sodium+Codeine Phosphate|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349889|NCT04066426|BG001|Baseline|Naproxen Sodium+Dexamethasone|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349890|NCT04066426|BG002|Baseline|Naproxen Sodium|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349891|NCT04066426|BG003|Baseline|Paracetamol|"Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349892|NCT04066426|BG004|Baseline|Total|Total of all reporting groups
11349893|NCT04066426|FG000|Participant Flow|Naproxen Sodium+Codeine Phosphate|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349894|NCT04066426|FG001|Participant Flow|Naproxen Sodium+Dexamethasone|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349895|NCT04066426|FG002|Participant Flow|Naproxen Sodium|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349896|NCT04066426|FG003|Participant Flow|Paracetamol|"Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11166268|NCT01973231|BG000|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
11229140|NCT02395653|EG000|Reported Event|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
11229141|NCT02395692|BG000|Baseline|Treatment (Methoxyamine, Temozolomide)|"Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Methoxyamine: Given PO~Temozolomide: Given PO"
11229142|NCT02395692|FG000|Participant Flow|Arm1 Methoxyamine &Temozolomide (Bevacizumab-naïve)|"Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-naive~Laboratory Biomarker Analysis: Correlative studies~Methoxyamine: Given PO~Temozolomide: Given PO"
11229143|NCT02395692|FG001|Participant Flow|Arm2 Methoxyamine & Temozolomide (Bevacizumab-refractory)|"Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-refractory~Laboratory Biomarker Analysis: Correlative studies~Methoxyamine: Given PO~Temozolomide: Given PO"
11229144|NCT02395692|OG000|Outcome|Arm1 Methoxyamine&Temozolomide (Bevacizumab-naïve)|"Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (Bevacizumab-naïve)~Laboratory Biomarker Analysis: Correlative studies~Methoxyamine: Given PO~Temozolomide: Given PO"
11229145|NCT02395692|OG001|Outcome|Arm2 Methoxyamine&Temozolomide (Bevacizumab-refractory)|"Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-refractory~Laboratory Biomarker Analysis: Correlative studies~Methoxyamine: Given PO~Temozolomide: Given PO"
11229146|NCT02395692|OG000|Outcome|Treatment (Methoxyamine, Temozolomide)|"Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Treatment (methoxyamine, temozolomide): Correlative studies~Methoxyamine: Given PO~Temozolomide: Given PO"
11229147|NCT02395692|OG000|Outcome|Treatment (Methoxyamine, Temozolomide)|"Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Methoxyamine: Given PO~Temozolomide: Given PO"
11229148|NCT02395692|EG000|Reported Event|Treatment (Methoxyamine, Temozolomide)|"Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Methoxyamine: Given PO~Temozolomide: Given PO"
11229149|NCT02395822|BG000|Baseline|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
11229150|NCT02395822|FG000|Participant Flow|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
11229151|NCT02395822|OG000|Outcome|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
11229152|NCT02395822|EG000|Reported Event|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
11229153|NCT02395978|BG000|Baseline|Part I: 1 PDC-1421 Capsule|1 PDC-1421 Capsule TID, p.o. after meal for 28 days
11166269|NCT01973231|BG001|Baseline|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
11166270|NCT01973231|BG002|Baseline|Total|Total of all reporting groups
11166271|NCT01973231|FG000|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
11166272|NCT01973231|FG001|Participant Flow|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
11166273|NCT01973231|OG000|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
11166274|NCT01973231|OG001|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
11166275|NCT01973231|EG000|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
11166276|NCT01973231|EG001|Reported Event|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
11166277|NCT01973283|BG000|Baseline|Medication Treatment|"Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.~Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant."
11166278|NCT01973283|FG000|Participant Flow|Medication Treatment-8 Weeks|"Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.~Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant."
11166279|NCT01973283|OG000|Outcome|Medication Treatment|"Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.~Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant."
11166280|NCT01973283|OG000|Outcome|Frail|Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty.
11166281|NCT01973283|OG001|Outcome|Not/Intermediate Frail|Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics).
11166282|NCT01973283|EG000|Reported Event|Medication Treatment-8 Weeks|"Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.~Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant."
11166283|NCT01973335|BG000|Baseline|Acetazolamide/Low-dose Loop Diuretics, Upfront Spironolactone|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are >5 mmol/L."
11166284|NCT01973335|BG001|Baseline|High-dose Loop Diuretics, Upfront Spironolactone|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are >5 mmol/L."
11166285|NCT01973335|BG002|Baseline|Acetazolamide/Low-dose Loop Diuretics, no Spironolactone|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Spironolactone use is prohibited during the first 72 h, but encouraged at discharge"
11349897|NCT04066426|OG000|Outcome|Naproxen Sodium+Codeine Phosphate|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349898|NCT04066426|OG001|Outcome|Naproxen Sodium+Dexamethasone|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349899|NCT04066426|OG002|Outcome|Naproxen Sodium|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349900|NCT04066426|OG003|Outcome|Paracetamol|"Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349901|NCT04066426|EG000|Reported Event|Naproxen Sodium+Codeine Phosphate|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349902|NCT04066426|EG001|Reported Event|Naproxen Sodium+Dexamethasone|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349903|NCT04066426|EG002|Reported Event|Naproxen Sodium|"Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349904|NCT04066426|EG003|Reported Event|Paracetamol|"Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.~naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders."
11349905|NCT04061694|BG000|Baseline|Digital Immediate Loading|"Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing~Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded."
11349906|NCT04061694|BG001|Baseline|Immediate Loading|Immediate loading: Only subjected to immediate loading. Conventional procedure.
11349907|NCT04061694|BG002|Baseline|Total|Total of all reporting groups
11349908|NCT04061694|FG000|Participant Flow|Digital Immediate Loading|"Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing~Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded."
11349909|NCT04061694|FG001|Participant Flow|Immediate Loading|Immediate loading: Only subjected to immediate loading. Conventional procedure.
11349910|NCT04061694|OG000|Outcome|Digital Immediate Loading|"Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing~Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded."
11349911|NCT04061694|OG001|Outcome|Immediate Loading|Immediate loading: Only subjected to immediate loading. Conventional procedure.
11349912|NCT04061694|EG000|Reported Event|Digital Immediate Loading|"Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing~Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded."
11349913|NCT04061694|EG001|Reported Event|Immediate Loading|Immediate loading: Only subjected to immediate loading. Conventional procedure.
11349914|NCT04060654|BG000|Baseline|SUBLOCADE|"All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100mg or 300mg) for up to 5 total injections~Sublocade: SUBLOCADE to be administered approximately every 4 weeks per local standard of care"
11349915|NCT04060654|FG000|Participant Flow|SUBLOCADE|"All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator for up to 5 total injections~Sublocade: SUBLOCADE to be administered approximately every 4 weeks per local standard of care"
11349916|NCT04060654|OG000|Outcome|SUBLOCADE|Participants who completed the INDV-6000-403 study and met study inclusion and exclusion criteria were given the option to enroll in this study. Baseline measures from the INDV-6000-403 study served also as baseline measures for this study. A total of 17 participants were screened and a total of 17 (100%) were enrolled into the study and received SUBLOCADE 300 mg at injection 1; subsequent doses could be reduced to 100 mg at the discretion of the investigator. Participants returned to the clinic approximately every 4 weeks for injection site assessments, urinary drug screens, pregnancy tests if applicable, subsequent injections and were assessed for the occurrence of any TEAEs. All other interventions were per clinic standard of care.
11349917|NCT04060654|EG000|Reported Event|SUBLOCADE|"All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100mg or 300 mg) for up to 5 total injections~Sublocade: SUBLOCADE to be administered approximately every 4 weeks per local standard of care"
11349918|NCT04059250|BG000|Baseline|All Study Participants|"All participants received both the Nobio flange and the traditional composite control flange.~On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.~Nobio composite: Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers~On the traditional composite control flange side of the lower same partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite.~traditional composite: traditional composite which has no bactericidal activities"
11349919|NCT04059250|FG000|Participant Flow|Nobio Flange|"On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.~Nobio composite: Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers"
11089345|NCT01523457|EG000|Reported Event|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
11229154|NCT02395978|BG001|Baseline|Part I: 2 PDC-1421 Capsule|2 PDC-1421 Capsule TID, p.o. after meal for 28 days
11229155|NCT02395978|BG002|Baseline|Part II: 2 PDC-1421 Capsule|"2 PDC-1421 Capsule TID, p.o. after meal for 42 days~PDC-1421 Capsule"
11229156|NCT02395978|BG003|Baseline|Part II: 1 PDC-1421 Capsule Plus 1 Placebo|"1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days~PDC-1421 Capsule~placebo"
11229157|NCT02395978|BG004|Baseline|Part II: 2 Placebo|"2 placebo TID, p.o. after meal for 42 days~placebo"
11229158|NCT02395978|BG005|Baseline|Total|Total of all reporting groups
11229159|NCT02395978|FG000|Participant Flow|Part I: 1 PDC-1421 Capsule|1 PDC-1421 Capsule thrice daily (TID), oral administration (p.o.) after meal for 28 days
11229160|NCT02395978|FG001|Participant Flow|Part I: 2 PDC-1421 Capsule|2 PDC-1421 Capsule TID, p.o. after meal for 28 days
11229161|NCT02395978|FG002|Participant Flow|Part II: 2 PDC-1421 Capsule|"2 PDC-1421 Capsule TID, p.o. after meal for 42 days~PDC-1421 Capsule"
11229162|NCT02395978|FG003|Participant Flow|Part II: 1 PDC-1421 Capsule Plus 1 Placebo|"1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days~PDC-1421 Capsule~placebo"
11229163|NCT02395978|FG004|Participant Flow|Part II: 2 Placebo|"2 placebo TID, p.o. after meal for 42 days~placebo"
11229164|NCT02395978|OG000|Outcome|Part II: 2 PDC-1421 Capsule|"2 PDC-1421 Capsule TID, p.o. after meal for 42 days~PDC-1421 Capsule"
11229165|NCT02395978|OG001|Outcome|Part II: 1 PDC-1421 Capsule Plus 1 Placebo|"1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days~PDC-1421 Capsule~placebo"
11229166|NCT02395978|OG002|Outcome|Part II: 2 Placebo|"2 placebo TID, p.o. after meal for 42 days~placebo"
11229167|NCT02395978|OG000|Outcome|Part II: 2 PDC-1421 Capsule|2 PDC-1421 Capsule TID, p.o. after meal for 42 days
10887803|NCT00502840|BG000|Baseline|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
10887804|NCT00502840|FG000|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 milligrams (mg) weekly; participants may also have been receiving a stable dose of folic acid. Participants with Disease Activity Score Based on 28 Joint Count (DAS28) greater than or equal to (≥)2.6 and an improvement in DAS28 greater than (>0.6) 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
10887805|NCT00502840|OG000|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
10887806|NCT00502840|OG000|Outcome|Rituximab Pluse MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
10887807|NCT00502840|EG000|Reported Event|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
11166286|NCT01973335|BG003|Baseline|High-dose Loop Diuretics, no Spironolactone|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~Spironolactone use is prohibited during the first 72 h, but encouraged at discharge"
11166287|NCT01973335|BG004|Baseline|Total|Total of all reporting groups
11166288|NCT01973335|FG000|Participant Flow|Acetazolamide/Low-dose Loop Diuretics, Upfront Spironolactone|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are >5 mmol/L."
11166289|NCT01973335|FG001|Participant Flow|High-dose Loop Diuretics, Upfront Spironolactone|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are >5 mmol/L."
11166290|NCT01973335|FG002|Participant Flow|Acetazolamide/Low-dose Loop Diuretics, no Spironolactone|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Spironolactone use is prohibited during the first 72 h, but encouraged at discharge."
11166291|NCT01973335|FG003|Participant Flow|High-dose Loop Diuretics, no Spironolactone|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~Spironolactone use is prohibited during the first 72 h, but encouraged at discharge."
11166292|NCT01973335|OG000|Outcome|Acetazolamide/Low-dose Loop Diuretics, Upfront Spironolactone|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are >5 mmol/L."
11229168|NCT02395978|OG001|Outcome|Part II: 1 PDC-1421 Capsule Plus 1 Placebo|1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
11229169|NCT02395978|OG002|Outcome|Part II: 2 Placebo|2 placebo TID, p.o. after meal for 42 days
11229170|NCT02395978|EG000|Reported Event|Part I: 1 PDC-1421 Capsule|1 PDC-1421 Capsule TID, p.o. after meal for 28 days
10887808|NCT00502853|BG000|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
10887809|NCT00502853|FG000|Participant Flow|Rituximab Plus (+) Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg per week (mg/week) by mouth or parenterally. Nonresponsive participants (defined as Disease Activity Score Based on 28-Joint Count and C-Reactive Protein [DAS28-CRP] score of greater than [>]2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
10887810|NCT00502853|OG000|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
10887811|NCT00502853|OG000|Outcome|Rituximab + MTX|Participants received 1000 mg of Rituximab by IV infusion on Days 1 and 15 (considered to be one cycle). Participants also received 10-25 mg/week stable concomitant MTX by mouth or parenterally. Additional cycles of 2 infusions each could be administered provided the following: a minimum of 24 weeks had passed since the first infusion of the last course of study medication; the participant had a DAS28-CRP score of >2.6; the participant had a neutrophil count not below 1.5x10^3/μL; there was an absence of significant cardiac or pulmonary disease, primary or secondary immunodeficiency, and infections.
11349920|NCT04059250|FG001|Participant Flow|Traditional Composite Control Flange|"On the traditional control composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional control composite.~traditional composite: traditional composite which has no bactericidal activities"
11349921|NCT04059250|OG000|Outcome|Nobio Flange|"On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.~Nobio composite: Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers"
11349922|NCT04059250|OG001|Outcome|Traditional Composite Flange|"On the traditional composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite.~traditional composite: traditional composite which has no bactericidal activities"
11349923|NCT04059250|EG000|Reported Event|Nobio Flange|"On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.~Nobio composite: Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers"
11349924|NCT04059250|EG001|Reported Event|Traditional Composite Flange|"On the traditional composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite.~traditional composite: traditional composite which has no bactericidal activities"
10887812|NCT00502853|EG000|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
10887813|NCT00502905|BG000|Baseline|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
11349925|NCT04058353|BG000|Baseline|Control: IVA or TEZ/IVA|Following an IVA or TEZ/IVA run-in period of 4 weeks, participants either received IVA 150 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 8 weeks.
11349926|NCT04058353|BG001|Baseline|TC: ELX/TEZ/IVA|Following an IVA or TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 8 weeks.
11349927|NCT04058353|BG002|Baseline|Total|Total of all reporting groups
11349928|NCT04058353|FG000|Participant Flow|Control: IVA or TEZ/IVA|Following an IVA (ivacaftor) or TEZ (tezacaftor)/IVA run-in period of 4 weeks, participants either received IVA 150 milligrams (mg) every 12 hours (q12h) or TEZ 100 mg once daily (qd)/IVA 150 mg q12h in the treatment period for 8 weeks.
11349929|NCT04058353|FG001|Participant Flow|Triple Combination (TC): ELX/TEZ/IVA|Following an IVA or TEZ/IVA run-in period of 4 weeks, participants received ELX (elexacaftor) 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 8 weeks.
11349930|NCT04058353|OG000|Outcome|TC: ELX/TEZ/IVA|Following an IVA or TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 8 weeks.
11349931|NCT04058353|OG000|Outcome|Control: IVA or TEZ/IVA|Following an IVA or TEZ/IVA run-in period of 4 weeks, participants either received IVA 150 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 8 weeks.
11349932|NCT04058353|OG001|Outcome|TC: ELX/TEZ/IVA|Following an IVA or TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 8 weeks.
10887814|NCT00502905|FG000|Participant Flow|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
10887815|NCT00502905|OG000|Outcome|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
11229171|NCT02395978|EG001|Reported Event|Part I: 2 PDC-1421 Capsule|2 PDC-1421 Capsule TID, p.o. after meal for 28 days
11229172|NCT02395978|EG002|Reported Event|Part II: 2 PDC-1421 Capsule|2 PDC-1421 Capsule TID, p.o. after meal for 42 days
11229173|NCT02395978|EG003|Reported Event|Part II: 1 PDC-1421 Capsule Plus 1 Placebo|1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
11229174|NCT02395978|EG004|Reported Event|Part II: 2 Placebo|2 placebo TID, p.o. after meal for 42 days
11229175|NCT02395991|BG000|Baseline|Observe1|"Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)~gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration~Magnetic resonance imaging (MRI): Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases.~precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state."
11229176|NCT02395991|FG000|Participant Flow|EOB-MRI|"Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)~gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration~Magnetic resonance imaging (MRI): Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases.~precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state."
11229177|NCT02395991|OG000|Outcome|EOB-MRI|"Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)~gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration~Magnetic resonance imaging (MRI): Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases.~precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state."
11229178|NCT02395991|OG000|Outcome|Observe1|"Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)~gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration~Magnetic resonance imaging (MRI): Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases.~precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state."
11229179|NCT02395991|EG000|Reported Event|EOB-MRI|"Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)~gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration~Magnetic resonance imaging (MRI): Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases.~precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state."
11229180|NCT02396147|BG000|Baseline|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
11229181|NCT02396147|BG001|Baseline|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
11229182|NCT02396147|BG002|Baseline|Total|Total of all reporting groups
11229183|NCT02396147|FG000|Participant Flow|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
11229184|NCT02396147|FG001|Participant Flow|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
11229185|NCT02396147|OG000|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229186|NCT02396147|OG001|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229187|NCT02396147|OG002|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229188|NCT02396147|OG003|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11349933|NCT04058353|EG000|Reported Event|Control: IVA or TEZ/IVA|Following an IVA or TEZ/IVA run-in period of 4 weeks, participants either received IVA 150 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 8 weeks.
10887816|NCT00502905|EG000|Reported Event|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
11349934|NCT04058353|EG001|Reported Event|TC: ELX/TEZ/IVA|Following an IVA or TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 8 weeks.
11349935|NCT04057248|BG000|Baseline|Individual's Quality of Life and Clinical Parameters|"Clinical parameters (HbA1C, weight, lipids profile, etc.)~Dario Blood Glucose Monitoring System: Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform~CDE: Certified Diabetes Educator Sessions"
11349936|NCT04057248|FG000|Participant Flow|Individual's Quality of Life and Clinical Parameters|"Clinical parameters (HbA1C, weight, lipids profile, etc.)~Dario Blood Glucose Monitoring System: Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform~CDE: Certified Diabetes Educator Sessions"
11349937|NCT04057248|OG000|Outcome|Individual's Quality of Life and Clinical Parameters|"Clinical parameters (HbA1C, weight, lipids profile, etc.)~Dario Blood Glucose Monitoring System: Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform~CDE: Certified Diabetes Educator Sessions"
11349938|NCT04057248|EG000|Reported Event|Individual's Quality of Life and Clinical Parameters|"Clinical parameters (HbA1C, weight, lipids profile, etc.)~Dario Blood Glucose Monitoring System: Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform~CDE: Certified Diabetes Educator Sessions"
11349939|NCT04055519|BG000|Baseline|Overall|LID017569 and Biofinity contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
11349940|NCT04055519|FG000|Participant Flow|LID017569, Then Biofinity|Lehfilcon A contact lenses worn in Period 1, with comfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
11349941|NCT04055519|FG001|Participant Flow|Biofinity, Then LID017569|Comfilcon A contact lenses worn in Period 1, with lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
11349942|NCT04055519|OG000|Outcome|LID017569|Lehfilcon A contact lenses worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
11349943|NCT04055519|OG001|Outcome|Biofinity|Comfilcon A contact lenses worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
11349944|NCT04055519|EG000|Reported Event|Pre-treatment|Events reported in this group occurred prior to exposure to the study contact lenses
11349945|NCT04055519|EG001|Reported Event|LID017569 Ocular|Events reported in this group occurred while exposed to lehfilcon A contact lenses
11349946|NCT04055519|EG002|Reported Event|LID017569 Nonocular/Systemic|Events reported in this group occurred while exposed to lehfilcon A contact lenses
11349947|NCT04055519|EG003|Reported Event|Biofinity Ocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
11349948|NCT04055519|EG004|Reported Event|Biofinity Nonocular/Systemic|Events reported in this group occurred while exposed to comfilcon A contact lenses
11349949|NCT04055675|BG000|Baseline|Asymptomatic Male Volunteers|"These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.~Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip."
11349950|NCT04055675|BG001|Baseline|Asymptomatic Female Volunteers|"These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female.~Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip."
11349951|NCT04055675|BG002|Baseline|Total|Total of all reporting groups
11349952|NCT04055675|FG000|Participant Flow|Asymptomatic Male Volunteers|"These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.~Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip."
10887817|NCT00502944|BG000|Baseline|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
11349953|NCT04055675|FG001|Participant Flow|Asymptomatic Female Volunteers|"These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female.~Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip."
11349954|NCT04055675|OG000|Outcome|Asymptomatic Male Volunteers|"These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.~Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip."
11349955|NCT04055675|OG001|Outcome|Asymptomatic Female Volunteers|"These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female.~Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip."
11349956|NCT04055675|EG000|Reported Event|Asymptomatic Male Volunteers|"These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.~Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip."
11349957|NCT04055675|EG001|Reported Event|Asymptomatic Female Volunteers|"These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female.~Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip."
11349958|NCT04054765|BG000|Baseline|Teens in the Invite Only VR Videogame|"155 adolescents playing the Invite Only VR intervention~videogame: Invite Only VR videogame"
11349959|NCT04054765|BG001|Baseline|Teens Receive Treatment as Usual|"132 adolescents receive treatment as usual~treatment as usual: treatment as usual"
11349960|NCT04054765|BG002|Baseline|Total|Total of all reporting groups
11349961|NCT04054765|FG000|Participant Flow|Teens in the Invite Only VR Videogame|"155 adolescents played the Invite Only VR intervention for 2-4 sessions for approximately 40 minutes per session. These 2-4 play sessions play took place following the pre-test at baseline. The post-test was administered immediately after the final play session.~videogame: Invite Only VR videogame Invite Only VR is a VR, story-based videogame intervention that teaches adolescents aged 11 to 17 years about the health risks of using e-cigarettes while providing a virtual environment to practice refusing peer pressure to vape e-cigarettes."
11166293|NCT01973335|OG001|Outcome|High-dose Loop Diuretics, Upfront Spironolactone|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are >5 mmol/L."
11166294|NCT01973335|OG002|Outcome|Acetazolamide/Low-dose Loop Diuretics, no Spironolactone|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Spironolactone use is prohibited during the first 72 h, but encouraged at discharge."
11166295|NCT01973335|OG003|Outcome|High-dose Loop Diuretics, no Spironolactone|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~Spironolactone use is prohibited during the first 72 h, but encouraged at discharge."
11166296|NCT01973335|EG000|Reported Event|Acetazolamide/Low-dose Loop Diuretics, Upfront Spironolactone|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are >5 mmol/L."
11166297|NCT01973335|EG001|Reported Event|High-dose Loop Diuretics, Upfront Spironolactone|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~Patients receive open-label oral spironolactone at a dose of 25 mg unless serum potassium levels are >5 mmol/L."
11166298|NCT01973335|EG002|Reported Event|Acetazolamide/Low-dose Loop Diuretics, no Spironolactone|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~Spironolactone use is prohibited during the first 72 h, but encouraged at discharge."
11166299|NCT01973335|EG003|Reported Event|High-dose Loop Diuretics, no Spironolactone|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~Spironolactone use is prohibited during the first 72 h, but encouraged at discharge."
11166300|NCT01973348|BG000|Baseline|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
11166301|NCT01973348|BG001|Baseline|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
11166302|NCT01973348|BG002|Baseline|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
11166303|NCT01973348|BG003|Baseline|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
11166304|NCT01973348|BG004|Baseline|Total|Total of all reporting groups
11166305|NCT01973348|FG000|Participant Flow|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
11166306|NCT01973348|FG001|Participant Flow|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
11166307|NCT01973348|FG002|Participant Flow|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
11166308|NCT01973348|FG003|Participant Flow|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
11166309|NCT01973348|OG000|Outcome|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
11166310|NCT01973348|OG001|Outcome|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
11166311|NCT01973348|OG002|Outcome|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
11166312|NCT01973348|OG003|Outcome|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
11166313|NCT01973348|EG000|Reported Event|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
11166314|NCT01973348|EG001|Reported Event|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
11166315|NCT01973348|EG002|Reported Event|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
11166316|NCT01973348|EG003|Reported Event|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
11349962|NCT04054765|FG001|Participant Flow|Teens Receive Treatment as Usual|"132 adolescents receive treatment as usual~This includes attending regular health class in public school in which the dangers of e-cigarettes are discussed.~treatment as usual: treatment as usual"
11349963|NCT04054765|OG000|Outcome|Teens in the Invite Only VR Videogame|"155 adolescents playing the Invite Only VR intervention~videogame: Invite Only VR videogame"
11349964|NCT04054765|OG001|Outcome|Teens Receive Treatment as Usual|"132 adolescents receive treatment as usual~treatment as usual: treatment as usual"
11349965|NCT04054765|EG000|Reported Event|Teens in the Invite Only VR Videogame|"155 adolescents playing the Invite Only VR intervention~videogame: Invite Only VR videogame"
11349966|NCT04054765|EG001|Reported Event|Teens Receive Treatment as Usual|"132 adolescents receive treatment as usual, which includes regular instruction in health class regarding the dangers of e-cigarettes~treatment as usual: treatment as usual"
11349967|NCT04054011|BG000|Baseline|Deoxycholic Acid|"Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.)~Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous"
11349968|NCT04054011|FG000|Participant Flow|Deoxycholic Acid|"Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.)~Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous"
11349969|NCT04054011|OG000|Outcome|Deoxycholic Acid|single arm study without comparison
11349970|NCT04054011|OG000|Outcome|Deoxycholic Acid ?Placebo|Deoxycholic acid / Placebo
11349971|NCT04054011|OG000|Outcome|Deoxycholic Acid|"Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.)~Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous"
11349972|NCT04054011|EG000|Reported Event|Deoxycholic Acid|"Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.)~Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous"
11349973|NCT04059094|BG000|Baseline|Placebo|2 puffs of matching placebo were inhaled orally via the Respimat® inhaler twice daily for a treatment period of 4 weeks in patients with cystic fibrosis.
11349974|NCT04059094|BG001|Baseline|BI 1265162 20μg b.i.d.|2 puffs of 10 micrograms (μg) BI 1265162 (Total: 20μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 40μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349975|NCT04059094|BG002|Baseline|BI 1265162 50μg b.i.d.|2 puffs of 25 micrograms (μg) BI 1265162 (Total: 50μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 100μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349976|NCT04059094|BG003|Baseline|BI 1265162 100μg b.i.d.|2 puffs of 50 micrograms (μg) BI 1265162 (Total: 100μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 200μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349977|NCT04059094|BG004|Baseline|BI 1265162 200μg b.i.d.|2 puffs of 100 micrograms (μg) BI 1265162 (Total: 200μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 400μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349978|NCT04059094|BG005|Baseline|Total|Total of all reporting groups
11349979|NCT04059094|FG000|Participant Flow|Placebo|2 puffs of matching placebo were inhaled orally via the Respimat® inhaler twice daily for a treatment period of 4 weeks in patients with cystic fibrosis.
11349980|NCT04059094|FG001|Participant Flow|BI 1265162 20μg b.i.d.|2 puffs of 10 micrograms (μg) BI 1265162 (Total: 20μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 40μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349981|NCT04059094|FG002|Participant Flow|BI 1265162 50μg b.i.d.|2 puffs of 25 micrograms (μg) BI 1265162 (Total: 50μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 100μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349982|NCT04059094|FG003|Participant Flow|BI 1265162 100μg b.i.d.|2 puffs of 50 micrograms (μg) BI 1265162 (Total: 100μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 200μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349983|NCT04059094|FG004|Participant Flow|BI 1265162 200μg b.i.d.|2 puffs of 100 micrograms (μg) BI 1265162 (Total: 200μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 400μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349984|NCT04059094|OG000|Outcome|Placebo|2 puffs of matching placebo were inhaled orally via the Respimat® inhaler twice daily for a treatment period of 4 weeks in patients with cystic fibrosis.
11349985|NCT04059094|OG001|Outcome|BI 1265162 20μg b.i.d.|2 puffs of 10 micrograms (μg) BI 1265162 (Total: 20μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 40μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349986|NCT04059094|OG002|Outcome|BI 1265162 50μg b.i.d.|2 puffs of 25 micrograms (μg) BI 1265162 (Total: 50μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 100μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349987|NCT04059094|OG003|Outcome|BI 1265162 100μg b.i.d.|2 puffs of 50 micrograms (μg) BI 1265162 (Total: 100μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 200μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349988|NCT04059094|OG004|Outcome|BI 1265162 200μg b.i.d.|2 puffs of 100 micrograms (μg) BI 1265162 (Total: 200μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 400μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349989|NCT04059094|OG000|Outcome|BI 1265162 20μg b.i.d.|2 puffs of 10 micrograms (μg) BI 1265162 (Total: 20μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 40μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349990|NCT04059094|OG001|Outcome|BI 1265162 50μg b.i.d.|2 puffs of 25 micrograms (μg) BI 1265162 (Total: 50μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 100μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349991|NCT04059094|OG002|Outcome|BI 1265162 100μg b.i.d.|2 puffs of 50 micrograms (μg) BI 1265162 (Total: 100μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 200μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349992|NCT04059094|OG003|Outcome|BI 1265162 200μg b.i.d.|2 puffs of 100 micrograms (μg) BI 1265162 (Total: 200μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 400μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349993|NCT04059094|EG000|Reported Event|Placebo|2 puffs of matching placebo were inhaled orally via the Respimat® inhaler twice daily for a treatment period of 4 weeks in patients with cystic fibrosis.
11349994|NCT04059094|EG001|Reported Event|BI 1265162 20μg b.i.d.|2 puffs of 10 micrograms (μg) BI 1265162 (Total: 20μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 40μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349995|NCT04059094|EG002|Reported Event|BI 1265162 50μg b.i.d.|2 puffs of 25 micrograms (μg) BI 1265162 (Total: 50μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 100μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349996|NCT04059094|EG003|Reported Event|BI 1265162 100μg b.i.d.|2 puffs of 50 micrograms (μg) BI 1265162 (Total: 100μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 200μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349997|NCT04059094|EG004|Reported Event|BI 1265162 200μg b.i.d.|2 puffs of 100 micrograms (μg) BI 1265162 (Total: 200μg) were inhaled orally via the Respimat® inhaler twice daily (b.i.d., daily dose: 400μg) for a treatment period of 4 weeks in patients with cystic fibrosis.
11349998|NCT04051684|BG000|Baseline|TAP, Bupivacaine|"This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.~Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.~Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle."
11349999|NCT04051684|BG001|Baseline|No Intervention|General anesthesia
11350000|NCT04051684|BG002|Baseline|Total|Total of all reporting groups
11350001|NCT04051684|FG000|Participant Flow|TAP, Bupivacaine|"This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.~Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.~Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle."
11350002|NCT04051684|FG001|Participant Flow|No Intervention|General anesthesia
11350003|NCT04051684|OG000|Outcome|TAP, Bupivacaine|"This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.~Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.~Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle."
11350004|NCT04051684|OG001|Outcome|No Intervention|General anesthesia
11350005|NCT04051684|EG000|Reported Event|TAP, Bupivacaine|"This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.~Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.~Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle."
11350006|NCT04051684|EG001|Reported Event|No Intervention|General anesthesia
11350007|NCT04046341|BG000|Baseline|Behavioral Sleep Intervention|"Caregivers attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime.~Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message."
11350008|NCT04046341|FG000|Participant Flow|Behavioral Sleep Intervention|"Caregivers attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime.~Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message."
11350009|NCT04046341|OG000|Outcome|Behavioral Sleep Intervention|"Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime.~Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message."
11350010|NCT04046341|EG000|Reported Event|Behavioral Sleep Intervention|"Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime.~Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message."
11350011|NCT04045964|BG000|Baseline|Motivational Advice and Free NRT|"nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home~motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA)."
11350012|NCT04045964|BG001|Baseline|Quitline Referral|Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
11350013|NCT04045964|BG002|Baseline|Total|Total of all reporting groups
11350014|NCT04045964|FG000|Participant Flow|Motivational Advice and Free NRT|"nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home~motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA)."
11350015|NCT04045964|FG001|Participant Flow|Quitline Referral|Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
11350016|NCT04045964|OG000|Outcome|Motivational Advice and Free NRT|"nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home~motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA)."
11350017|NCT04045964|OG001|Outcome|Quitline Referral|Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
11350018|NCT04045964|EG000|Reported Event|Motivational Advice and Free NRT|"nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home~motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA)."
11350019|NCT04045964|EG001|Reported Event|Quitline Referral|Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
11350020|NCT04043416|BG000|Baseline|System + Fall Prevention First, Then Fall Prevention|"Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone.~Motivating reminiscence technology: The jDome BikeAround uses Google Street V"
11350021|NCT04043416|BG001|Baseline|Fall Prevention First, Then System +Fall Prevention|"Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program~Motivating reminiscence technology: The jDome BikeAround uses Google Street V"
11350022|NCT04043416|BG002|Baseline|Total|Total of all reporting groups
11350023|NCT04043416|FG000|Participant Flow|System+Fall Prevention First, Then Fall Prevention Alone|"Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone.~Fall Prevention Program focuses on reducing the incidence of residents' falls and mitigating risks of falls through a resident focused, team approach which ensures that a resident's environment and social, physical, cognitive and emotional strengths are supported. This is an interdisciplinary program involving nursing and program staff, physician/pharmacist, dietician, physiotherapist, housekeeping staff and the resident/POA. They communicate regarding their planned interventions and evaluation of resident progress and outcomes in falls prevention through documentation."
11350024|NCT04043416|FG001|Participant Flow|Fall Prevention First, Then System+Fall Prevention|Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Fall Prevention Program focuses on reducing the incidence of residents' falls and mitigating risks of falls through a resident focused, team approach which ensures that a resident's environment and social, physical, cognitive and emotional strengths are supported. This is an interdisciplinary program involving nursing and program staff, physician/pharmacist, dietician, physiotherapist, housekeeping staff and the resident/POA. They communicate regarding their planned interventions and evaluation of resident progress and outcomes in falls prevention through documentation.
11350025|NCT04043416|OG000|Outcome|System + Fall Prevention First, Then Fall Prevention|"Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone.~Motivating reminiscence technology: The jDome BikeAround uses Google Street V"
11350026|NCT04043416|OG001|Outcome|Fall Prevention First, Then System +Fall Prevention|"Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program~Motivating reminiscence technology: The jDome BikeAround uses Google Street V"
11350027|NCT04043416|OG000|Outcome|System + Fall Prevention First, Then Fall Prevention|"Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone.~Motivating reminiscence technology: The jDome BikeAround"
11350028|NCT04043416|OG001|Outcome|Fall Prevention First, Then System +Fall Prevention|Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program
11350029|NCT04043416|OG000|Outcome|System + Fall Prevention First, Then Fall Prevention|Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone.
11350030|NCT04043416|EG000|Reported Event|System + Fall Prevention First, Then Fall Prevention|"Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone.~Motivating reminiscence technology: The jDome BikeAround uses Google Street V"
11350031|NCT04043416|EG001|Reported Event|Fall Prevention First, Then System +Fall Prevention|"Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program~Motivating reminiscence technology: The jDome BikeAround uses Google Street V"
11350032|NCT04057768|BG000|Baseline|Intervention|"Device: Venus Viva~Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars."
11350033|NCT04057768|FG000|Participant Flow|Venus Viva™ Device|Venus Viva™ Device: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
11350034|NCT04057768|OG000|Outcome|Intervention|"Device: Venus Viva~Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars."
11350035|NCT04057768|EG000|Reported Event|Intervention|"Device: Venus Viva~Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars."
11350036|NCT04052542|BG000|Baseline|Traditional Online Continuing Education Group - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in traditional online continuing education.
11350037|NCT04052542|BG001|Baseline|Traditional Online Continuing Education Group - During Education|Patients admitted during the one-month education period to the ICU that participated in traditional online continuing education.
11350038|NCT04052542|BG002|Baseline|Traditional Online Continuing Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in traditional online continuing education.
11350039|NCT04052542|BG003|Baseline|Interprofessional Education Group - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in interprofessional education.
11350040|NCT04052542|BG004|Baseline|Interprofessional Education - During Education|Patients admitted during the one-month education period to the ICU that participated in interprofessional education.
11350041|NCT04052542|BG005|Baseline|Interprofessional Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in interprofessional education.
11350042|NCT04052542|BG006|Baseline|Just-in-time Education - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in just-in-time education.
11350043|NCT04052542|BG007|Baseline|Just-in-time Education Group - During Education|Patients admitted during the one-month education period to the ICU that participated in just-in-time education.
11350044|NCT04052542|BG008|Baseline|Just-in-time Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in just-in-time education.
11350045|NCT04052542|BG009|Baseline|Traditional Online Continuing Education Group - Learners|Learners who participated in traditional online continuing education
11350046|NCT04052542|BG010|Baseline|Interprofessional Education Group - Learners|Learners who participated in interprofessional education
11350047|NCT04052542|BG011|Baseline|Just-in-time Education Group - Learners|Learners who participated in just-in-time education
11350048|NCT04052542|BG012|Baseline|Total|Total of all reporting groups
11350049|NCT04052542|FG000|Participant Flow|Traditional Online Continuing Education Group - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in traditional online continuing education.
11350050|NCT04052542|FG001|Participant Flow|Traditional Online Continuing Education Group - During Education|Patients admitted during the one-month education period to the ICU that participated in traditional online continuing education.
11350051|NCT04052542|FG002|Participant Flow|Traditional Online Continuing Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in traditional online continuing education.
11350052|NCT04052542|FG003|Participant Flow|Interprofessional Education Group - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in interprofessional education.
11350053|NCT04052542|FG004|Participant Flow|Interprofessional Education - During Education|Patients admitted during the one-month education period to the ICU that participated in interprofessional education.
11350054|NCT04052542|FG005|Participant Flow|Interprofessional Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in interprofessional education.
11350055|NCT04052542|FG006|Participant Flow|Just-in-time Education - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in just-in-time education.
11350056|NCT04052542|FG007|Participant Flow|Just-in-time Education Group - During Education|Patients admitted during the one-month education period to the ICU that participated in just-in-time education.
11350057|NCT04052542|FG008|Participant Flow|Just-in-time Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in just-in-time education.
11350058|NCT04052542|FG009|Participant Flow|Traditional Online Continuing Education Group - Learners|Learners who participated in traditional online continuing education
11350059|NCT04052542|FG010|Participant Flow|Interprofessional Education Group - Learners|Learners who participated in interprofessional education
11350060|NCT04052542|FG011|Participant Flow|Just-in-time Education Group - Learners|Learners who participated in just-in-time education
11350061|NCT04052542|OG000|Outcome|Traditional Online Continuing Education Group - Learners|Learners who participated in traditional online continuing education
11350062|NCT04052542|OG001|Outcome|Interprofessional Education Group - Learners|Learners who participated in interprofessional education
11350063|NCT04052542|OG002|Outcome|Just-in-time Education Group - Learners|Learners who participated in just-in-time education
11350064|NCT04052542|OG000|Outcome|Traditional Online Continuing Education Group - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in traditional online continuing education.
11350065|NCT04052542|OG001|Outcome|Traditional Online Continuing Education Group - During Education|Patients admitted during the one-month education period to the ICU that participated in traditional online continuing education.
11350066|NCT04052542|OG002|Outcome|Traditional Online Continuing Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in traditional online continuing education.
11350067|NCT04052542|OG003|Outcome|Interprofessional Education Group - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in interprofessional education.
11350068|NCT04052542|OG004|Outcome|Interprofessional Education - During Education|Patients admitted during the one-month education period to the ICU that participated in interprofessional education.
11350069|NCT04052542|OG005|Outcome|Interprofessional Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in interprofessional education.
11350070|NCT04052542|OG006|Outcome|Just-in-time Education - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in just-in-time education.
11229189|NCT02396147|OG004|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229190|NCT02396147|OG005|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229191|NCT02396147|EG000|Reported Event|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229192|NCT02396147|EG001|Reported Event|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229193|NCT02396147|EG002|Reported Event|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229194|NCT02396147|EG003|Reported Event|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229195|NCT02396147|EG004|Reported Event|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229196|NCT02396147|EG005|Reported Event|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
11229197|NCT02396160|BG000|Baseline|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
11229198|NCT02396160|BG001|Baseline|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
11229199|NCT02396160|BG002|Baseline|Total|Total of all reporting groups
11229200|NCT02396160|FG000|Participant Flow|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
11229201|NCT02396160|FG001|Participant Flow|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
11229202|NCT02396160|OG000|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
11229203|NCT02396160|OG001|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
11229204|NCT02396160|EG000|Reported Event|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
11229205|NCT02396160|EG001|Reported Event|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
11229206|NCT02396212|BG000|Baseline|Canakinumab 4 mg/kg Every 4 Weeks|All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.
11229207|NCT02396212|FG000|Participant Flow|Canakinumab 4 mg/kg Every 4 Weeks|All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.
11229208|NCT02396212|OG000|Outcome|Canakinumab 4 mg/kg Every 4 Weeks|All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.
11229209|NCT02396212|EG000|Reported Event|Canakinumab 4 mg/kg Every 4 Weeks|All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.
11229210|NCT02396251|BG000|Baseline|Both Cheeks Group|HA product under investigation in both cheeks
11229211|NCT02396251|BG001|Baseline|Split-face Group|HA product under investigation in one cheek and a comparator in the other cheek.
11229212|NCT02396251|BG002|Baseline|Total|Total of all reporting groups
11229213|NCT02396251|FG000|Participant Flow|Both Cheeks Group|HA product under investigation in both cheeks
11229214|NCT02396251|FG001|Participant Flow|Split-face Group|HA product under investigation in one cheek and a comparator in the other cheek.
11229215|NCT02396251|OG000|Outcome|Both Cheeks Group|Subjects with at least 1 step improvement on validated photo scale in both cheeks as assessed by the Blinded evaluator, Both cheeks group
11229216|NCT02396251|EG000|Reported Event|Both Cheeks Group|HA product under investigation in both cheeks
11229217|NCT02396251|EG001|Reported Event|Split-face Group|HA product under investigation in one cheek and a comparator in the other cheek.
11233907|NCT02431468|EG001|Reported Event|Bryostatin 1 40ug|"Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11350071|NCT04052542|OG007|Outcome|Just-in-time Education Group - During Education|Patients admitted during the one-month education period to the ICU that participated in just-in-time education.
11350072|NCT04052542|OG008|Outcome|Just-in-time Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in just-in-time education.
11350073|NCT04052542|EG000|Reported Event|Traditional Online Continuing Education Group - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in traditional online continuing education.
11350074|NCT04052542|EG001|Reported Event|Traditional Online Continuing Education Group - During Education|Patients admitted during the one-month education period to the ICU that participated in traditional online continuing education.
11350075|NCT04052542|EG002|Reported Event|Traditional Online Continuing Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in traditional online continuing education.
11350076|NCT04052542|EG003|Reported Event|Interprofessional Education Group - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in interprofessional education.
11350077|NCT04052542|EG004|Reported Event|Interprofessional Education - During Education|Patients admitted during the one-month education period to the ICU that participated in interprofessional education.
11350078|NCT04052542|EG005|Reported Event|Interprofessional Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in interprofessional education.
11350079|NCT04052542|EG006|Reported Event|Just-in-time Education - Pre-education|Patients admitted during the 6 months prior to the education period to the ICU that would later participate in just-in-time education.
11350080|NCT04052542|EG007|Reported Event|Just-in-time Education Group - During Education|Patients admitted during the one-month education period to the ICU that participated in just-in-time education.
11350081|NCT04052542|EG008|Reported Event|Just-in-time Education Group - Post-education|Patients admitted during the 6 months after the education period to the ICU that participated in just-in-time education.
11350082|NCT04052542|EG009|Reported Event|Traditional Online Continuing Education Group - Learners|Learners who participated in traditional online continuing education
11350083|NCT04052542|EG010|Reported Event|Interprofessional Education Group - Learners|Learners who participated in interprofessional education
11350084|NCT04052542|EG011|Reported Event|Just-in-time Education Group - Learners|Learners who participated in just-in-time education
11350085|NCT04054193|BG000|Baseline|Fosaprepitant Treatment|Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine [5-HT]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
11350086|NCT04054193|FG000|Participant Flow|Fosaprepitant Treatment|Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine [5-HT]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
11350087|NCT04054193|OG000|Outcome|Fosaprepitant Treatment|Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine [5-HT]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
11350088|NCT04054193|EG000|Reported Event|Fosaprepitant Cycle 1|Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine [5-HT]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy.
11350089|NCT04054193|EG001|Reported Event|Fosaprepitant Cycles 2-3|Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during Cycles 2-3. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy, of each 17-day cycle.
11350090|NCT04050618|BG000|Baseline|Ocufilcon D Control Lens, Then Fanfilcon A Test Lens|"Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.~ocufilcon D control lens: hydrogel contact lens~fanfilcon A test lens: Silicone hydrogel contact lens"
11350091|NCT04050618|BG001|Baseline|Etafilcon A Controls, Then Fanfilcon A Test Lens|"Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.~etafilcon A control lens: hydrogel contact lens~fanfilcon A test lens: Silicone hydrogel contact lens"
11350092|NCT04050618|BG002|Baseline|Total|Total of all reporting groups
11350093|NCT04050618|FG000|Participant Flow|Ocufilcon D Control Lens, Then Fanfilcon A Test Lens|"Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.~ocufilcon D control lens: hydrogel contact lens~fanfilcon A test lens: Silicone hydrogel contact lens"
11350094|NCT04050618|FG001|Participant Flow|Etafilcon A Controls, Then Fanfilcon A Test Lens|"Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.~etafilcon A control lens: hydrogel contact lens~fanfilcon A test lens: Silicone hydrogel contact lens"
11350095|NCT04050618|OG000|Outcome|Ocufilcon D - Group A|"Subjects were randomized to wear ocufilcon D control lens for four weeks.~Ocufilcon D - hydrogel contact lens"
11350096|NCT04050618|OG001|Outcome|Fanfilcon A - Group A|"Subjects were randomized to wear fanfilcon A test lens for four weeks.~Fanfilcon A - SiHy contact lens"
11350097|NCT04050618|OG002|Outcome|Etafilcon A - Group B|"Subjects were randomized to wear etafilcon A control lens for two weeks.~Etafilcon A - hydrogel contact lens"
11350098|NCT04050618|OG003|Outcome|Fanfilcon A - Group B|"Subjects were randomized to wear fanfilcon A test lens for two weeks.~Fanfilcon A - SiHy contact lens"
11350099|NCT04050618|OG001|Outcome|Fanfilcon A - Group A|"Subjects were randomized to wear fanfilcon A test lens for four weeks.~fanfilcon A - SiHy contact lenses"
11350100|NCT04050618|EG000|Reported Event|Ocufilcon D - Group A|"Subjects were randomized to wear ocufilcon D control lens for four weeks.~Ocufilcon D - hydrogel contact lens"
11350101|NCT04050618|EG001|Reported Event|Fanfilcon A - Group A|"Subjects were randomized to wear fanfilcon A test lens for four weeks.~Fanfilcon A - SiHy contact lens"
11350102|NCT04050618|EG002|Reported Event|Etafilcon A - Group B|"Subjects were randomized to wear etafilcon A control lens for two weeks.~Etafilcon A - hydrogel contact lens"
11350103|NCT04050618|EG003|Reported Event|Fanfilcon A - Group B|"Subjects were randomized to wear fanfilcon A test lens for two weeks.~Fanfilcon A - SiHy contact lens"
11350104|NCT04053465|BG000|Baseline|Exercise in Heat Group|"Exercise in a hot environment~Heat acclimation: 14 days of aerobic exercise in a hot environment"
11350105|NCT04053465|BG001|Baseline|Exercise in Cool Group|"Exercise in a cool environment~Exercise in a cool environment: 14 days of aerobic exercise in a cool environment"
11350106|NCT04053465|BG002|Baseline|Total|Total of all reporting groups
11350107|NCT04053465|FG000|Participant Flow|Exercise in Heat Group|"Exercise in a hot environment~Heat acclimation: 14 days of aerobic exercise in a hot environment"
11350108|NCT04053465|FG001|Participant Flow|Exercise in Cool Group|"Exercise in a cool environment~Exercise in a cool environment: 14 days of aerobic exercise in a cool environment"
11350109|NCT04053465|OG000|Outcome|Exercise in Heat Group|"Exercise in a hot environment~Heat acclimation: 14 days of aerobic exercise in a hot environment"
11350110|NCT04053465|OG001|Outcome|Exercise in Cool Group|"Exercise in a cool environment~Exercise in a cool environment: 14 days of aerobic exercise in a cool environment"
11350111|NCT04053465|EG000|Reported Event|Exercise in Heat Group|"Exercise in a hot environment~Heat acclimation: 14 days of aerobic exercise in a hot environment"
11350112|NCT04053465|EG001|Reported Event|Exercise in Cool Group|"Exercise in a cool environment~Exercise in a cool environment: 14 days of aerobic exercise in a cool environment"
11350113|NCT04053270|BG000|Baseline|Group A|"Group A was administered active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300~Afamelanotide: 16mg subcutaneous implant~Placebo: Placebo subcutaneous implant"
11350114|NCT04053270|BG001|Baseline|Group B|"Group B was administered placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300~Afamelanotide: 16mg subcutaneous implant~Placebo: Placebo subcutaneous implant"
11350115|NCT04053270|BG002|Baseline|Total|Total of all reporting groups
11350116|NCT04053270|FG000|Participant Flow|Group A|"Group A was administered active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300.~Afamelanotide: 16mg subcutaneous implant Placebo: Placebo subcutaneous implant"
11350117|NCT04053270|FG001|Participant Flow|Group B|"Group B was administered placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300.~Afamelanotide: 16mg subcutaneous implant. Placebo: Placebo subcutaneous implant."
11166317|NCT01973387|BG000|Baseline|Ibrutinib|Receive 420 mg ibrutinib (3 x 140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
11350118|NCT04053270|OG000|Outcome|Afamelanotide|Afamelanotide: 16mg subcutaneous implant
11350119|NCT04053270|OG001|Outcome|Placebo|Placebo: Placebo subcutaneous implant.
11350120|NCT04053270|OG000|Outcome|Group A|"Afamelanotide: 16mg subcutaneous implant~Of the 60 participants, 32 were in treatment Group A (active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300) and 28 in treatment Group B (placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300)."
11350121|NCT04053270|OG001|Outcome|Group B|"Placebo: Placebo subcutaneous implant.~Of the 60 participants, 32 were in treatment Group A (active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300) and 28 in treatment Group B (placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300)."
11350122|NCT04053270|OG000|Outcome|Group A|"Group A was administered active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300.~Afamelanotide: 16mg subcutaneous implant Placebo: Placebo subcutaneous implant"
11166318|NCT01973387|BG001|Baseline|Rituximab|Receive rituximab IV infusion 375 mg/m2 on Day 1 of Cycle 1 and 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).
11166319|NCT01973387|BG002|Baseline|Total|Total of all reporting groups
11166320|NCT01973387|FG000|Participant Flow|Ibrutinib|Receive 420 mg ibrutinib (3 x 140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
11350123|NCT04053270|OG001|Outcome|Group B|"Group B was administered placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300.~Afamelanotide: 16mg subcutaneous implant. Placebo: Placebo subcutaneous implant."
11350124|NCT04053270|EG000|Reported Event|Afamelanotide|Afamelanotide: 16mg subcutaneous implant.
11350125|NCT04053270|EG001|Reported Event|Placebo|Placebo: Placebo subcutaneous implant.
11350126|NCT04049552|BG000|Baseline|Overall Study Participants|"Rapamycin ointment will be applied to one keloid on the subject and placebo will be applied to a second keloid.~Keloids will be color coded to match ointment applied~Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment"
11350127|NCT04049552|FG000|Participant Flow|Overall Study Participants|"Rapamycin ointment will be applied to one keloid on the subject, and placebo will be applied to the second keloid on that subject. Keloids will be color coded to match either rapamycin ointment or placebo.~Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment"
11350128|NCT04049552|OG000|Outcome|RAPA Intervention|"Rapamycin ointment will be applied to one keloid on the subject~Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin"
11350129|NCT04049552|OG001|Outcome|Placebo|"Placebo will be applied as a control on one keloid on the subject~Placebo: Petrolatum ointment placebo"
11350130|NCT04049552|EG000|Reported Event|RAPA Intervention|"Rapamycin ointment will be applied to one keloid on the subject~Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin"
11350131|NCT04049552|EG001|Reported Event|Placebo|"Placebo will be applied as a control on one keloid on the subject~Placebo: Petrolatum ointment placebo"
11166321|NCT01973387|FG001|Participant Flow|Rituximab|Receive rituximab IV infusion 375 mg/m2 on Day 1 of Cycle 1 and 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).
11166322|NCT01973387|OG000|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
11166323|NCT01973387|OG001|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligrams per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
11166324|NCT01973387|EG000|Reported Event|Ibrutinib|Receive 420 mg ibrutinib (3 x 140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
11166325|NCT01973387|EG001|Reported Event|Rituximab|Receive rituximab IV infusion 375 mg/m2 on Day 1 of Cycle 1 and 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).
11166326|NCT01973413|BG000|Baseline|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
11166327|NCT01973413|BG001|Baseline|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.~Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
11166328|NCT01973413|BG002|Baseline|Total|Total of all reporting groups
11166329|NCT01973413|FG000|Participant Flow|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
11166330|NCT01973413|FG001|Participant Flow|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.~Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
11166331|NCT01973413|OG000|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
11166332|NCT01973413|OG001|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
11166333|NCT01973413|OG000|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
11166334|NCT01973413|EG000|Reported Event|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
11166335|NCT01973413|EG001|Reported Event|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
11350132|NCT04053023|BG000|Baseline|Part A: OCA 10 mg Followed by OCA 10 mg + Linerixibat 90 mg|In Period 1, participants received OCA 10 milligram (mg), tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19). In Period 2 participants were administered OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (study Day 20 to Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (study Day 20 to the morning of Day 38). There was no washout period between Period 1 and Period 2.
11350133|NCT04053023|BG001|Baseline|Part B: OCA 5mg or 10mg Followed by OCA 10mg+Linerixibat 180mg|In Part B, participants were planned to receive OCA 5 mg or 10 mg, tablets, orally, once daily (evening dose) for 19 days (study Day 1 to Day 19) in Period 1; followed by OCA 10 mg, tablets, orally, once daily (evening dose) for 18 days (study Day 20 to Day 37) along with linerixibat 180 mg, tablets, orally, once daily for 18.5 days (study Day 20 to the morning of Day 38) in Period 2. There was no planned washout period between Period 1 and Period 2.
11350134|NCT04053023|BG002|Baseline|Total|Total of all reporting groups
10887818|NCT00502944|BG001|Baseline|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
10887819|NCT00502944|BG002|Baseline|Total|Total of all reporting groups
11350135|NCT04053023|FG000|Participant Flow|Part A: OCA 10 mg Followed by OCA 10 mg + Linerixibat 90 mg|In Period 1, participants received OCA 10 milligram (mg), tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19). In Period 2 participants were administered OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (study Day 20 to Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (study Day 20 to the morning of Day 38). There was no washout period between Period 1 and Period 2.
11350136|NCT04053023|FG001|Participant Flow|Part B: OCA 5mg or 10mg Followed by OCA 10mg+Linerixibat 180mg|In Part B, participants were planned to receive OCA 5 mg or 10 mg, tablets, orally, once daily (evening dose) for 19 days (study Day 1 to Day 19) in Period 1; followed by OCA 10 mg, tablets, orally, once daily (evening dose) for 18 days (study Day 20 to Day 37) along with linerixibat 180 mg, tablets, orally, once daily for 18.5 days (study Day 20 to the morning of Day 38) in Period 2. There was no planned washout period between Period 1 and Period 2.
11350137|NCT04053023|OG000|Outcome|Part A: OCA 10 mg|In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
11350138|NCT04053023|OG000|Outcome|Part A: OCA 10 mg + Linerixibat 90 mg|In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
11350139|NCT04053023|OG000|Outcome|Part B: OCA 5 mg or 10 mg|In Part B, participants were planned to receive OCA 5 mg or 10 mg, tablets, orally, once daily (evening dose) for 19 days (from study Day 1 to Day 19) in Period 1.
11350140|NCT04053023|OG000|Outcome|Part B: OCA 5mg or 10mg + Linerixibat 180 mg|In Part B, participants were planned to receive OCA 5 mg or 10 mg, tablets, orally, once daily (evening dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 180 mg, tablets, orally, once daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
11350141|NCT04053023|OG001|Outcome|Part A: OCA 10 mg + Linerixibat 90 mg|In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
11350142|NCT04053023|OG001|Outcome|Part B: OCA 5mg or 10mg + Linerixibat 180 mg|In Part B, participants were planned to receive OCA 5 mg or 10 mg, tablets, orally, once daily (evening dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 180 mg, tablets, orally, once daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
11350143|NCT04053023|EG000|Reported Event|Part A: OCA 10 mg|In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
11350144|NCT04053023|EG001|Reported Event|Part A: OCA 10 mg + Linerixibat 90 mg|In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
11350145|NCT04051710|BG000|Baseline|Test Group|Subjects randomly enrolled into test group received test comparator, Beclomethasone dipropinate, 0.04 mg/INH to administer one inhalation twice daily
11350146|NCT04051710|BG001|Baseline|Reference Group|Subjects randomly enrolled into Reference group received Reference comparator, QVAR® containing Beclomethasone dipropinate, 0.04 mg/INH to administer one inhalation twice daily
11350147|NCT04051710|BG002|Baseline|Placebo Group|Subjects randomly enrolled into Placebo group received a Placebo device to administer one inhalation twice daily
11350148|NCT04051710|BG003|Baseline|Total|Total of all reporting groups
11350149|NCT04051710|FG000|Participant Flow|Group I (Test)|"One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily.~Test Product: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg"
11350150|NCT04051710|FG001|Participant Flow|Group II|"One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Reference) twice daily.~Reference Product: QVAR® Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg"
11350151|NCT04051710|FG002|Participant Flow|Group III (Placebo)|One inhalation of Placebo inhalation aerosol twice daily.
11350152|NCT04051710|OG000|Outcome|Group-I (Test)|"One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily.~Test Product: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg"
11350153|NCT04051710|OG001|Outcome|Group-II (Reference)|"One inhalation of QVAR® 40 mcg (Beclomethasone dipropionate HFA), Inhalation Aerosol twice daily.~Reference Product: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg"
11350154|NCT04051710|OG002|Outcome|Group-III (Placebo)|"One inhalation of Placebo Inhalation Aerosol twice daily.~Placebo: Placebo Product"
11350155|NCT04051710|EG000|Reported Event|Group I (Test)|"One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily.~Test Product: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg"
11350156|NCT04051710|EG001|Reported Event|Group II (Reference)|"One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Reference) twice daily.~Reference Product: QVAR® Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg"
11350157|NCT04051710|EG002|Reported Event|Group III (Placebo)|One inhalation of Placebo inhalation aerosol twice daily.
11350158|NCT04050865|BG000|Baseline|OTX-DP|OTX-DP
11350159|NCT04050865|BG001|Baseline|Placebo|Placebo Vehicle
11350160|NCT04050865|BG002|Baseline|Total|Total of all reporting groups
11350161|NCT04050865|FG000|Participant Flow|OTX-DP, 0.4 mg|OTX-DP, 0.4 mg
11350162|NCT04050865|FG001|Participant Flow|Placebo|Placebo Vehicle
11350163|NCT04050865|OG000|Outcome|OTX-DP|OTX-DP
11350164|NCT04050865|OG001|Outcome|Placebo|Placebo Vehicle
11350165|NCT04050865|EG000|Reported Event|OTX-DP|OTX-DP
11350166|NCT04050865|EG001|Reported Event|Placebo|Placebo Vehicle
11350167|NCT04050605|BG000|Baseline|Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test)|"Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.~somofilcon A toric contact lens: Contact Lens~fanfilcon A toric contact lens: Contact Lens"
11229218|NCT02396316|BG000|Baseline|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter [ml] * 40 milligram per milliliter [mg/ml]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
11229219|NCT02396316|BG001|Baseline|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
11229220|NCT02396316|BG002|Baseline|Total|Total of all reporting groups
11229221|NCT02396316|FG000|Participant Flow|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter [ml] * 40 milligram per milliliter [mg/ml]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
11229222|NCT02396316|FG001|Participant Flow|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
11229223|NCT02396316|OG000|Outcome|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml * 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
11229224|NCT02396316|OG001|Outcome|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
11229225|NCT02396316|EG000|Reported Event|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml * 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)"
11229226|NCT02396316|EG001|Reported Event|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)"
11229227|NCT02396316|EG002|Reported Event|Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1)|"Subjects received IVT injection of 2 mg (0.05 ml * 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator. (AE time frame: from the first dose of study drug until pre-dose at Week 1)"
11229228|NCT02396316|EG003|Reported Event|Sham Injection Group (Till Pre-dose at Week 1)|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator. (AE time frame: from the first dose of study drug until pre-dose at Week 1)"
11229229|NCT02396381|BG000|Baseline|THS 2.2 Use|≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.
11229230|NCT02396381|BG001|Baseline|CC Use|≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.
11229231|NCT02396381|BG002|Baseline|Dual Use|≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
11350168|NCT04050605|FG000|Participant Flow|Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test)|"Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.~somofilcon A toric contact lens: Contact Lens~fanfilcon A toric contact lens: Contact Lens"
11350169|NCT04050605|OG000|Outcome|Somofilcon A Toric (Habitual)|"Participants wore their habitual somofilcon A toric lens for 4-weeks.~somofilcon A toric contact lens: Contact Lens"
11350170|NCT04050605|OG000|Outcome|Fanfilcon A Toric Lens|"Participants were refitted with fanfilcon A toric lens.~fanfilcon A toric contact lens: Contact Lens"
11350171|NCT04050605|OG000|Outcome|Somofilcon A Toric (Habitual)|"Participants wore their habitual somofilcon A toric lens for 4-weeks..~somofilcon A toric contact lens: Contact Lens"
11350172|NCT04050605|OG000|Outcome|Somofilcon A Toric (Habitual)|"Participants wore their habitual somofilcon A toric lens for 4 weeks.~somofilcon A toric contact lens: Contact Lens"
11350173|NCT04050605|OG000|Outcome|fanfilconA Toric|"Participants were their refitted with fanfilcon A toric lens for 4-weeks..~fanfilcon A toric contact lens: Contact Lens"
11350174|NCT04050605|OG000|Outcome|Fanfilcon A Toric|"Participants were refitted with fanfilcon A toric lens for 4-weeks..~fanfilcon A toric contact lens: Contact Lens"
11350175|NCT04050605|EG000|Reported Event|Somofilcon A Toric (Habitual) Lens|"Participants are habitual wearers of somofilcon A toric lens for 4-weeks~somofilcon A toric contact lens: Contact Lens"
11350176|NCT04050605|EG001|Reported Event|Fanfilcon A Toric Contact Lens|"Participants were refitted with fanfilcon A toric lens for 4-weeks~fanfilcon A toric contact lens: Contact Lens"
11350177|NCT04050371|BG000|Baseline|Transgender Women|Transgender women on stable estradiol treatment.
11350178|NCT04050371|BG001|Baseline|Transgender Men|Transgender men on stable testosterone regimen.
11350179|NCT04050371|BG002|Baseline|Total|Total of all reporting groups
11350180|NCT04050371|FG000|Participant Flow|Transgender Men|Transgender men on stable testosterone regimen from the iBreathe Study
11166336|NCT01973439|BG000|Baseline|Single Arm|This is a single arm crossover study First intervention: PK assessment while on Twice Daily Abacavir Second intervention: PK assessment while on Once Daily Abacavir
11350181|NCT04050371|FG001|Participant Flow|Transgender Women|Transgender women on stable estradiol treatment from the iBreathe study.
11350182|NCT04050371|OG000|Outcome|Transgender Women|Transgender women on stable estradiol treatment.
11350183|NCT04050371|OG001|Outcome|Transgender Men|Transgender men on stable testosterone regimen.
11350184|NCT04050371|EG000|Reported Event|Transgender Women|Transgender Women (Male sex assigned at birth).
11350185|NCT04050371|EG001|Reported Event|Transgender Men|Transgender men (Female sex assigned at birth)
11350186|NCT04048460|BG000|Baseline|eAudiology|Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention will involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions will consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
11350187|NCT04048460|FG000|Participant Flow|eAudiology|Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
11350188|NCT04048460|OG000|Outcome|eAudiology|Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
11350189|NCT04048460|EG000|Reported Event|eAudiology|Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
11350190|NCT04048681|BG000|Baseline|Diet Soda/Regular Soda/ Carbonated Water|The same subjects participated in all three conditions.
11350191|NCT04048681|FG000|Participant Flow|Diet Soda Then Regular Soda Then Carbonated Water|Participant had first visit with 12oz can of diet soda, 7 days washout, then second visit with 12 oz can of regular soda, 7 days washout, then third visit with 12 oz can of carbonated water.
11350192|NCT04048681|FG001|Participant Flow|Regular Soda Then Carbonated Water Then Diet Soda|Participant had first visit with 12oz can of regular soda, 7 days washout, then second visit with 12 oz can of carbonated water, 7 days washout, then third visit with 12 oz can of diet soda.
11350193|NCT04048681|FG002|Participant Flow|Carbonated Water Then Diet Soda Then Regular Soda|Participant had first visit with 12oz can of carbonated water, 7 days washout, then second visit with 12 oz can of diet soda, 7 days washout, then third visit with 12 oz can of regular soda.
11350194|NCT04048681|FG003|Participant Flow|Regular Soda Then Diet Soda Then Carbonated Water|Participant had first visit with 12oz can of regular soda, 7 days washout, then second visit with 12 oz can of diet soda, 7 days washout, then third visit with 12 oz can of carbonated water.
11350195|NCT04048681|FG004|Participant Flow|Diet Soda Then Carbonated Water Then Regular Soda|Participant had first visit with 12oz can of diet soda, 7 days washout, then second visit with 12 oz can of carbonated water, 7 days washout, then third visit with 12 oz can of regular soda.
11350196|NCT04048681|OG000|Outcome|Diet Soda|"12oz can of Diet Coke~diet soda: 12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas)"
11350197|NCT04048681|OG001|Outcome|Soda|"12oz can of Coke~Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)"
11350198|NCT04048681|OG002|Outcome|Carbonated Water|"12oz can of carbonated (unflavored) water~Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored"
11350199|NCT04048681|EG000|Reported Event|Diet Soda|"12oz can of Diet Coke~diet soda: 12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas)"
11166337|NCT01973439|FG000|Participant Flow|Single Arm|"This is a single arm crossover study~st intervention: PK assessment while on Twice Daily Abacavir~nd intervention: PK assessment while on Once Daily Abacavir"
11166338|NCT01973439|OG000|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
11166339|NCT01973439|EG000|Reported Event|Abacavir Once Versus Twice Daily|This is a single arm study. Intervention 1: PK assessment while on Twice Daily Abacavir (Week 0) Intervention 2: PK assessment while on Once Daily Abacavir (Week 4)
11166340|NCT01973491|BG000|Baseline|ATX-MS-1467|Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
11166341|NCT01973491|FG000|Participant Flow|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
11166342|NCT01973491|OG000|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
11166343|NCT01973491|EG000|Reported Event|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
11166344|NCT01973569|BG000|Baseline|Denosumab 6 Months|"denosumab administered subcutaneously every 6 months~denosumab: denosumab administered subcutaneously"
11166345|NCT01973569|BG001|Baseline|Denosumab 3 Months|"denosumab administered subcutaneously every 3 months~denosumab: denosumab administered subcutaneously"
11166346|NCT01973569|BG002|Baseline|Placebo|"placebo administered subcutaneously to match denosumab~placebo: placebo administered subcutaneously to match denosumab"
11166347|NCT01973569|BG003|Baseline|Total|Total of all reporting groups
11166348|NCT01973569|FG000|Participant Flow|Denosumab 6 Months|"denosumab administered subcutaneously every 6 months~denosumab: denosumab administered subcutaneously"
11166349|NCT01973569|FG001|Participant Flow|Denosumab 3 Months|"denosumab administered subcutaneously every 3 months~denosumab: denosumab administered subcutaneously"
11166350|NCT01973569|FG002|Participant Flow|Placebo|"placebo administered subcutaneously to match denosumab~placebo: placebo administered subcutaneously to match denosumab"
11166351|NCT01973569|OG000|Outcome|Denosumab 6 Months|"denosumab administered subcutaneously every 6 months~denosumab: denosumab administered subcutaneously"
11166352|NCT01973569|OG001|Outcome|Denosumab 3 Months|"denosumab administered subcutaneously every 3 months~denosumab: denosumab administered subcutaneously"
11166353|NCT01973569|OG002|Outcome|Placebo|"placebo administered subcutaneously to match denosumab~placebo: placebo administered subcutaneously to match denosumab"
11166354|NCT01973569|EG000|Reported Event|Denosumab 6 Months|"denosumab administered subcutaneously every 6 months~denosumab: denosumab administered subcutaneously"
11166355|NCT01973569|EG001|Reported Event|Denosumab 3 Months|"denosumab administered subcutaneously every 3 months~denosumab: denosumab administered subcutaneously"
11166356|NCT01973569|EG002|Reported Event|Placebo|"placebo administered subcutaneously to match denosumab~placebo: placebo administered subcutaneously to match denosumab"
11166357|NCT01973595|BG000|Baseline|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
11166358|NCT01973595|BG001|Baseline|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
11166359|NCT01973595|BG002|Baseline|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste"
11166360|NCT01973595|BG003|Baseline|No Almonds, Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
11166361|NCT01973595|BG004|Baseline|Total|Total of all reporting groups
11166362|NCT01973595|FG000|Participant Flow|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
11166363|NCT01973595|FG001|Participant Flow|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
11166364|NCT01973595|FG002|Participant Flow|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
11166365|NCT01973595|FG003|Participant Flow|No Almonds Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
11166366|NCT01973595|OG000|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
11166367|NCT01973595|OG001|Outcome|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
11166368|NCT01973595|OG000|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
11229232|NCT02396381|BG003|Baseline|Other Use|Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
11229233|NCT02396381|BG004|Baseline|Total|Total of all reporting groups
11229234|NCT02396381|FG000|Participant Flow|THS 2.2 Group|Randomized to Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
11229235|NCT02396381|FG001|Participant Flow|CC Group|Randomized to Ad libitum use of CC in an ambulatory setting for 26 weeks
11229236|NCT02396381|OG000|Outcome|THS 2.2 Use|≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.
11229237|NCT02396381|OG001|Outcome|CC Use|≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.
11229238|NCT02396381|OG002|Outcome|Dual Use|≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
11229239|NCT02396381|OG003|Outcome|Other Use|Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
11229240|NCT02396381|EG000|Reported Event|THS 2.2 Group|Randomized to Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
11229241|NCT02396381|EG001|Reported Event|CC Group|Randomized to Ad libitum use of CC in an ambulatory setting for 26 weeks
11229242|NCT02396381|EG002|Reported Event|Product Test|Enrolled subjects who participated in a product test, but were not randomized.
11229243|NCT02396420|BG000|Baseline|Treatment Arm|"Prostate artery embolization (PAE) with Embosphere Microspheres.~Embosphere Microspheres"
11229244|NCT02396420|FG000|Participant Flow|Treatment Arm|"Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.~Embosphere Microspheres"
11229245|NCT02396420|OG000|Outcome|Treatment Arm|This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.
11229246|NCT02396420|OG000|Outcome|Treatment|This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.
11229247|NCT02396420|EG000|Reported Event|Treatment|This is a single arm study. All subjects with eligibility confirmed during the screening period and completing Visit 1 (Prostate Artery Embolization) within 4 weeks of screening are included in the arm.
11229248|NCT02396511|BG000|Baseline|TRC105 and Bevacizumab|"TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion~TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops~Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops"
11229249|NCT02396511|FG000|Participant Flow|TRC105 and Bevacizumab|"TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion~TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops~Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops"
11229250|NCT02396511|OG000|Outcome|TRC105 and Bevacizumab|"TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion~TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops~Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops"
11229251|NCT02396511|EG000|Reported Event|TRC105 and Bevacizumab|"TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion~TRC105: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops~Bevacizumab: Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops"
11229252|NCT02396537|BG000|Baseline|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
11229253|NCT02396537|BG001|Baseline|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
11229254|NCT02396537|BG002|Baseline|Total|Total of all reporting groups
11229255|NCT02396537|FG000|Participant Flow|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
11229256|NCT02396537|FG001|Participant Flow|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
11229257|NCT02396537|OG000|Outcome|Intranasal Lidocaine|Subjects were administered 4% lidocaine solution, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (intervention group).
11229258|NCT02396537|OG001|Outcome|Intranasal 0.9% Saline|Subjects were administered 0.9% saline, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (placebo group).
11229259|NCT02396537|EG000|Reported Event|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
11350200|NCT04048681|EG001|Reported Event|Soda|"12oz can of Coke~Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)"
11350201|NCT04048681|EG002|Reported Event|Carbonated Water|"12oz can of carbonated (unflavored) water~Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored"
11350202|NCT04046250|BG000|Baseline|TK112690|"TK112690 treatment~TK-112690: TK112690 treatment pre-methotrexate treatment"
11350203|NCT04046250|BG001|Baseline|Placebo|"TK112690 formulation~Placebo TK-112690: Placebo"
11350204|NCT04046250|BG002|Baseline|Total|Total of all reporting groups
11350205|NCT04046250|FG000|Participant Flow|TK112690|"TK112690 treatment~TK-112690: TK112690 treatment pre-methotrexate treatment"
11350206|NCT04046250|FG001|Participant Flow|Placebo|"TK112690 formulation~Placebo TK-112690: Placebo"
11350207|NCT04046250|OG000|Outcome|TK112690|"TK112690 treatment~TK-112690: TK112690 treatment pre-methotrexate treatment"
11350208|NCT04046250|OG001|Outcome|Placebo|"TK112690 formulation~Placebo TK-112690: Placebo"
11350209|NCT04046250|EG000|Reported Event|TK112690|"TK112690 treatment~TK-112690: TK112690 treatment pre-methotrexate treatment"
11350210|NCT04046250|EG001|Reported Event|Placebo|"TK112690 formulation~Placebo TK-112690: Placebo"
11350211|NCT04047342|BG000|Baseline|Standard Welcome Email|"The standard welcome email mentions the benefits of enrollment and the deadline for registering and having health measures on file, plus it provides registration steps and hyperlinks for registering and finding free health screenings.~Welcome email: Email"
11350212|NCT04047342|BG001|Baseline|Loss Frame Email|"The loss frame email recommends that GHP members not throw away a precise dollar amount in savings (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action.~Welcome email: Email~Loss frame: Email"
11350213|NCT04047342|BG002|Baseline|Total|Total of all reporting groups
11350214|NCT04047342|FG000|Participant Flow|Standard Welcome Email|"The standard welcome email mentions the benefits of enrollment and the deadline for registering and having health measures on file, plus it provides registration steps and hyperlinks for registering and finding free health screenings.~Welcome email: Email"
11350215|NCT04047342|FG001|Participant Flow|Loss Frame Email|"The loss frame email recommends that Geisinger Health Plan (GHP) members not throw away a precise dollar amount in savings (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action.~Welcome email: Email~Loss frame: Email"
11350216|NCT04047342|OG000|Outcome|Standard Welcome Email|"The standard welcome email mentions the benefits of enrollment and the deadline for registering and having health measures on file, plus it provides registration steps and hyperlinks for registering and finding free health screenings.~Welcome email: Email"
11166369|NCT01973595|OG001|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
11350217|NCT04047342|OG001|Outcome|Loss Frame Email|"The loss frame email recommends that GHP members not throw away a precise dollar amount in savings (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action.~Welcome email: Email~Loss frame: Email"
11350218|NCT04047342|EG000|Reported Event|Standard Welcome Email|"The standard welcome email mentions the benefits of enrollment and the deadline for registering and having health measures on file, plus it provides registration steps and hyperlinks for registering and finding free health screenings.~Welcome email: Email"
11350219|NCT04047342|EG001|Reported Event|Loss Frame Email|"The loss frame email recommends that GHP members not throw away a precise dollar amount in savings (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action.~Welcome email: Email~Loss frame: Email"
11350220|NCT04044352|BG000|Baseline|Study Group|Participants will receive 2 mL (approximately 5x10^6/mL tissue culture infective dose (TCID50)) of influenza A/Bethesda/MM2/H1N1challenge virus administered intranasally via a sprayer on Day 1.
11350221|NCT04044352|FG000|Participant Flow|Study Group|Participants will receive 2 mL (approximately 5x10^6/mL tissue culture infective dose (TCID50)) of influenza A/Bethesda/MM2/H1N1 challenge virus administered intranasally via a sprayer on Day 1.
11350222|NCT04044352|OG000|Outcome|Study Group|2 mL (approximately 5x10^6/mL tissue culture infective dose (TCID50)) of influenza A/Bethesda/MM2/H1N1 challenge virus administered intranasally via a sprayer on Day 1.
11350223|NCT04044352|OG000|Outcome|Study Group|2 mL (approximately 5x10^6/mL tissue culture infective dose (TCID50)) of influenza A/Bethesda/MM2/H1N1challenge virus administered intranasally via a sprayer on Day 1.
11350224|NCT04044352|EG000|Reported Event|Group 1|"2 mL (approximately 5x10^6/mL tissue culture infective dose (TCID50)) of influenza A/Bethesda/MM2/H1N1challenge virus administered intranasally via a sprayer on Day 1. N=80.~Influenza A/Bethesda/MM2/H1N1 Challenge: Reverse-genetics derived live A/California/04/2009/H1N1-like influenza virus passaged six times in Vero cells."
11350225|NCT04043728|BG000|Baseline|Mindfulness|"This module introduces mindfulness training skills, with the goal of cultivating nonjudgmental, present-focused experience of emotions, thoughts, and physical sensations related to cigarette smoking. By progressing though a series of experiential exercises (e.g., awareness of the breath, anchoring in the present), this module seeks to reduce maladaptive attempts to control negative emotions and facilitate tolerance of the physical and emotional symptoms of nicotine withdrawal.~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350226|NCT04043728|BG001|Baseline|Interoceptive Exposure (Practice Quitting)|"This module introduces interoceptive exposure, a technique in which participants purposefully and systematically complete exercises to evoke physical sensations typically associated with anxiety and distress, in order to reduce fear and avoidance of these sensations. Interoceptive exercises will focus on a gradual exposure to nicotine withdrawal symptoms, through a series of 'practice quit attempts' (i.e., brief periods of smoking abstinence without intention to permanently quit).~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11089346|NCT01523457|EG001|Reported Event|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
11089347|NCT01523496|BG000|Baseline|HIV+ With Vit D Supplementation|HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose
11089348|NCT01523496|BG001|Baseline|HIV+ Young Adults With Vitamin D Control Dose|HIV+ receiving Vitamin D low dose: 18,000 IU per month
11089349|NCT01523496|BG002|Baseline|HIV - With Vitamin D Supplementation|HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month.
11089350|NCT01523496|BG003|Baseline|HIV - With Vitamin D Control Dose|HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month
11089351|NCT01523496|BG004|Baseline|Total|Total of all reporting groups
11089352|NCT01523496|FG000|Participant Flow|HIV+ With Vit D Supplementation|HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose
11089353|NCT01523496|FG001|Participant Flow|HIV+ Young Adults With Vitamin D Control Dose|HIV+ receiving Vitamin D low dose: 18,000 IU per month
11089354|NCT01523496|FG002|Participant Flow|HIV - With Vitamin D Supplementation|HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month.
11089355|NCT01523496|FG003|Participant Flow|HIV - With Vitamin D Control Dose|HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month
11089356|NCT01523496|OG000|Outcome|HIV Positive on Vit D Control Dose|HIV+ receiving low vitamin D dose 18,000 IU per month
11089357|NCT01523496|OG001|Outcome|HIV Positive on Vit D Supplementation Dose|HIV-infected young adults receiving a supplementation dose of vitamin D (either medium dose of 60,000 IU per month or a high dose of 120,000 IU/month)
11089358|NCT01523496|OG002|Outcome|HIV Negative on Vitamin D Control Dose|HIV negative controls receiving Vitamin D low dose: 18,000 IU per month
11089359|NCT01523496|OG003|Outcome|HIV Negative on Vitamin D Supplementation Dose|HIV negative controls receiving Vitamin D medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month
11089360|NCT01523496|OG000|Outcome|HIV + on Vitamin D Control Dose|HIV+ receiving vitamin D low dose: 18,000 IU per month
11089361|NCT01523496|OG001|Outcome|HIV + on Vit D Supplementation Dose|HIV+ receiving Vitamin D supplementation (medium dose: 60,000 IU per month or higher dose: 120,000 IU/month)
11089362|NCT01523496|OG002|Outcome|HIV Negative on Vit D Control Dose|HIV negative controls on Vitamin D low dose: 18,000 IU per month
11089363|NCT01523496|OG003|Outcome|HIV Negative on Vit D Supplementation Dose|HIV negative controls on vitamin D supplementation: medium dose of 60,000 IU per month or higher dose of 120,000 IU/month
11089364|NCT01523496|EG000|Reported Event|HIV + on Vitamin D Control Dose|HIV+ receiving vitamin D control dose ( low dose: 18,000 IU per month)
11089365|NCT01523496|EG001|Reported Event|HIV+ on Vitamin D Supplementation Dose|HIV+ receiving vitamin D supplementation doses (medium dose of 60,000 IU per month or higher dose of 120,000 IU/month)
11089366|NCT01523496|EG002|Reported Event|HIV - on Vitamin D Control Dose|HIV negative patients receiving vitamin D control dose (low dose of 18,000 IU per month)
11089367|NCT01523496|EG003|Reported Event|HIV- on Vitamin D Supplementation Dose|HIV negative patients receiving vitamin D supplementation doses (medium dose of 60,000 IU per month or higher dose of 120,000 IU/month)
11089368|NCT01523587|BG000|Baseline|Afatinib|Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
11089369|NCT01523587|BG001|Baseline|Erlotinib|Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
11089370|NCT01523587|BG002|Baseline|Total|Total of all reporting groups
11350227|NCT04043728|BG002|Baseline|Behavioral Activation (Countering Emotional Behaviors)|"This module introduces behavioral activation, which seeks to increase positive emotions by systematically introducing greater engagement with natural rewards. Treatment sessions focus on the identification of avoidance strategies, including cigarette smoking as a coping strategy for negative emotions. The goal of this treatment module is to replace smoking with adaptive coping strategies to facilitate contact with and enjoyment of reinforcing activities that are incompatible with smoking.~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350228|NCT04043728|BG003|Baseline|Total|Total of all reporting groups
11350229|NCT04043728|FG000|Participant Flow|Mindfulness|"This module introduces mindfulness training skills, with the goal of cultivating nonjudgmental, present-focused experience of emotions, thoughts, and physical sensations related to cigarette smoking. By progressing though a series of experiential exercises (e.g., awareness of the breath, anchoring in the present), this module seeks to reduce maladaptive attempts to control negative emotions and facilitate tolerance of the physical and emotional symptoms of nicotine withdrawal.~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350230|NCT04043728|FG001|Participant Flow|Interoceptive Exposure (Practice Quitting)|"This module introduces interoceptive exposure, a technique in which participants purposefully and systematically complete exercises to evoke physical sensations typically associated with anxiety and distress, in order to reduce fear and avoidance of these sensations. Interoceptive exercises will focus on a gradual exposure to nicotine withdrawal symptoms, through a series of 'practice quit attempts' (i.e., brief periods of smoking abstinence without intention to permanently quit).~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350231|NCT04043728|FG002|Participant Flow|Behavioral Activation (Countering Emotional Behaviors)|"This module introduces behavioral activation, which seeks to increase positive emotions by systematically introducing greater engagement with natural rewards. Treatment sessions focus on the identification of avoidance strategies, including cigarette smoking as a coping strategy for negative emotions. The goal of this treatment module is to replace smoking with adaptive coping strategies to facilitate contact with and enjoyment of reinforcing activities that are incompatible with smoking.~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350232|NCT04043728|OG000|Outcome|Mindfulness|"This module introduces mindfulness training skills, with the goal of cultivating nonjudgmental, present-focused experience of emotions, thoughts, and physical sensations related to cigarette smoking. By progressing though a series of experiential exercises (e.g., awareness of the breath, anchoring in the present), this module seeks to reduce maladaptive attempts to control negative emotions and facilitate tolerance of the physical and emotional symptoms of nicotine withdrawal.~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350233|NCT04043728|OG001|Outcome|Interoceptive Exposure (Practice Quitting)|"This module introduces interoceptive exposure, a technique in which participants purposefully and systematically complete exercises to evoke physical sensations typically associated with anxiety and distress, in order to reduce fear and avoidance of these sensations. Interoceptive exercises will focus on a gradual exposure to nicotine withdrawal symptoms, through a series of 'practice quit attempts' (i.e., brief periods of smoking abstinence without intention to permanently quit).~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350234|NCT04043728|OG002|Outcome|Behavioral Activation (Countering Emotional Behaviors)|"This module introduces behavioral activation, which seeks to increase positive emotions by systematically introducing greater engagement with natural rewards. Treatment sessions focus on the identification of avoidance strategies, including cigarette smoking as a coping strategy for negative emotions. The goal of this treatment module is to replace smoking with adaptive coping strategies to facilitate contact with and enjoyment of reinforcing activities that are incompatible with smoking.~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350235|NCT04043728|EG000|Reported Event|Mindfulness|"This module introduces mindfulness training skills, with the goal of cultivating nonjudgmental, present-focused experience of emotions, thoughts, and physical sensations related to cigarette smoking. By progressing though a series of experiential exercises (e.g., awareness of the breath, anchoring in the present), this module seeks to reduce maladaptive attempts to control negative emotions and facilitate tolerance of the physical and emotional symptoms of nicotine withdrawal.~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350236|NCT04043728|EG001|Reported Event|Interoceptive Exposure (Practice Quitting)|"This module introduces interoceptive exposure, a technique in which participants purposefully and systematically complete exercises to evoke physical sensations typically associated with anxiety and distress, in order to reduce fear and avoidance of these sensations. Interoceptive exercises will focus on a gradual exposure to nicotine withdrawal symptoms, through a series of 'practice quit attempts' (i.e., brief periods of smoking abstinence without intention to permanently quit).~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350237|NCT04043728|EG002|Reported Event|Behavioral Activation (Countering Emotional Behaviors)|"This module introduces behavioral activation, which seeks to increase positive emotions by systematically introducing greater engagement with natural rewards. Treatment sessions focus on the identification of avoidance strategies, including cigarette smoking as a coping strategy for negative emotions. The goal of this treatment module is to replace smoking with adaptive coping strategies to facilitate contact with and enjoyment of reinforcing activities that are incompatible with smoking.~Unified Protocol adapted for smoking cessation: Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt."
11350238|NCT04041453|BG000|Baseline|Albendazole 400mg|Albendazole 400mg in single dose
11350239|NCT04041453|BG001|Baseline|Albendazole/Ivermectin|Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
11350240|NCT04041453|BG002|Baseline|Albendazole 400mg x 3|Albendazole 400mg/day for 3 consecutive days
11350241|NCT04041453|BG003|Baseline|Albendazole/Ivermectin x 3|Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
11350242|NCT04041453|BG004|Baseline|Total|Total of all reporting groups
11350243|NCT04041453|FG000|Participant Flow|Albendazole 400mg|Albendazole 400mg in single dose
11350244|NCT04041453|FG001|Participant Flow|Albendazole/Ivermectin|Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
11350245|NCT04041453|FG002|Participant Flow|Albendazole 400mg x 3|Albendazole 400mg/day for 3 consecutive days.
11350246|NCT04041453|FG003|Participant Flow|Albendazole/Ivermectin x 3|Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
11350247|NCT04041453|OG000|Outcome|Albendazole 400mg|Albendazole 400mg in single dose
11350248|NCT04041453|OG001|Outcome|Albendazole/Ivermectin|Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
11350249|NCT04041453|OG002|Outcome|Albendazole 400mg x3|Albendazole 400mg/day for 3 consecutive days.
11350250|NCT04041453|OG003|Outcome|Albendazole/Ivermectin x 3|Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
11350251|NCT04041453|OG001|Outcome|Albendazole/Ivermectin|Albendazole 400mg + ivermectin 600mcg/kg in single dose.
11350252|NCT04041453|OG002|Outcome|Albendazole x 3|Albendazole 400mg/day for 3 consecutive days.
11350253|NCT04041453|EG000|Reported Event|Albendazole 400mg|Albendazole 400mg in single dose
11166370|NCT01973595|OG001|Outcome|No Almond Consumption Control|"Participants were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.~Each group received the almond intervention and the no almond consumption control."
11350254|NCT04041453|EG001|Reported Event|Albendazole/Ivermectin|Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose
11350255|NCT04041453|EG002|Reported Event|Albendazole 400mg x3|Albendazole 400mg/day in 3 consecutive days
11350256|NCT04041453|EG003|Reported Event|Albendazole/Ivermectin x 3|Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day in 3 consecutive days
11350257|NCT04041414|BG000|Baseline|Intervention Schools|"Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.~Proud & Empowered!: Proud & Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers."
10887820|NCT00502944|FG000|Participant Flow|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
11350258|NCT04041414|BG001|Baseline|Control Schools|Students in control schools will receive no intervention.
11350259|NCT04041414|BG002|Baseline|Total|Total of all reporting groups
10887821|NCT00502944|FG001|Participant Flow|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
10887822|NCT00502944|OG000|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
10887823|NCT00502944|OG001|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
11166371|NCT01973595|OG002|Outcome|Almonds Consumption (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
11350260|NCT04041414|FG000|Participant Flow|Intervention Schools|"Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.~Proud & Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers."
11350261|NCT04041414|FG001|Participant Flow|Control Schools|Students in control schools will receive no intervention.
11350262|NCT04041414|OG000|Outcome|Intervention Schools|"Students in intervention schools will receive the intervention in semester 1.~Proud & Empowered!: Proud & Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers."
11350263|NCT04041414|OG001|Outcome|Control Schools|Students in control schools will not receive any intervention.
11350264|NCT04041414|OG000|Outcome|Intervention Schools|"Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.~Proud & Empowered!: Proud & Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers."
11350265|NCT04041414|OG001|Outcome|Control Schools|Students in control schools will receive no intervention.
11350266|NCT04041414|OG000|Outcome|Intervention Schools|"Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.~Proud & Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers."
11350267|NCT04041414|EG000|Reported Event|Intervention Schools|"Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.~Proud & Empowered!: Proud & Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers."
11350268|NCT04041414|EG001|Reported Event|Control Schools|Students in control schools will receive no intervention.
11350269|NCT04041219|BG000|Baseline|Allogeneic Blood or Marrow Transplantation|"Subjects who had allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota~Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.~Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses"
11166372|NCT01973595|OG003|Outcome|No Almonds Consumption Control (Children)|"Children were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
11350270|NCT04041219|FG000|Participant Flow|Allogeneic Blood or Marrow Transplantation|"Subjects who had allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota~Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.~Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses"
11350271|NCT04041219|OG000|Outcome|Allogeneic Blood or Marrow Transplantation|"Subjects who had allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota~Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.~Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses"
10887824|NCT00502944|EG000|Reported Event|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
10887825|NCT00502944|EG001|Reported Event|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
10887826|NCT00502996|BG000|Baseline|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
10887827|NCT00502996|FG000|Participant Flow|Rituximab|Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 milligram (mg) IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
10887828|NCT00502996|OG000|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
10887829|NCT00502996|EG000|Reported Event|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
11350272|NCT04041219|EG000|Reported Event|Allogeneic Blood or Marrow Transplantation|"Subjects who had allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota~Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.~Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses"
11350273|NCT04041700|BG000|Baseline|Osia 2 System|Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.
11350274|NCT04041700|FG000|Participant Flow|Osia 2 System|Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.
11350275|NCT04041700|OG000|Outcome|Osia 2 System|Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.
11350276|NCT04041700|EG000|Reported Event|Osia 2 System|Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.
11350277|NCT04040933|BG000|Baseline|All Randomized Participants|All Participants with Fitzpatrick skin types II (burns easily; tans minimum)-III (burns moderately; tans gradually) with uniform skin color on forearms, minor wounds were created on forearms (four per arm) by a certified laser specialist received all eight intervention at the same time on the wounds created on forearms. Each wound site was subjected to one of eight randomly-assigned treatments included in an adhesive bandage that were: 1) a marketed adhesive bandage, 2) a marketed adhesive bandage (IP-benchmark control 1), 3) a non-marketed adhesive bandage (IP-benchmark control 2), 4-7) four non-marketed adhesive bandages (IP#1, IP#2, IP#3, IP#4), and 8) no treatment (uncovered, negative control). Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandages were not left on after a composite healing score of 8 was achieved.
11350278|NCT04040933|FG000|Participant Flow|All Randomized Participants|All Participants with Fitzpatrick skin types II (burns easily; tans minimum)-III (burns moderately; tans gradually) with uniform skin color on forearms, minor wounds were created on forearms (four per arm) by a certified laser specialist received all eight intervention at the same time on the wounds created on forearms. Each wound site was subjected to one of eight randomly-assigned treatments included in an adhesive bandage that were: 1) a marketed adhesive bandage, 2) a marketed adhesive bandage (IP-benchmark control 1), 3) a non-marketed adhesive bandage (IP-benchmark control 2), 4-7) four non-marketed adhesive bandages (IP#1, IP#2, IP#3, IP#4), and 8) no treatment (uncovered, negative control). Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandages were not left on after a composite healing score of 8 was achieved.
11350279|NCT04040933|OG000|Outcome|Negative Control|Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
11350280|NCT04040933|OG001|Outcome|Marketed Adhesive Bandage|Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
11350281|NCT04040933|OG002|Outcome|Marketed Adhesive Bandage IP-1 Benchmark Control 1|Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
11350282|NCT04040933|OG003|Outcome|Non-marketed Adhesive Bandage IP-Benchmark Control 2|Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
11350283|NCT04040933|OG004|Outcome|Non-marketed Adhesive Bandage IP #1|Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
11350284|NCT04040933|OG005|Outcome|Non-marketed Adhesive Bandage IP #2|Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
11350285|NCT04040933|OG006|Outcome|Non-marketed Adhesive Bandage IP #3|Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
11350286|NCT04040933|OG007|Outcome|Non-marketed Adhesive Bandage IP #4|Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
11350287|NCT04040933|EG000|Reported Event|All Randomized Participants|All Participants with Fitzpatrick skin types II (burns easily; tans minimum)-III (burns moderately; tans gradually) with uniform skin color on forearms, minor wounds were created on forearms (four per arm) by a certified laser specialist received all eight intervention at the same time on the wounds created on forearms. Each wound site was subjected to one of eight randomly-assigned treatments included in an adhesive bandage that were: 1) a marketed adhesive bandage, 2) a marketed adhesive bandage (IP-benchmark control 1), 3) a non-marketed adhesive bandage (IP-benchmark control 2), 4-7) four non-marketed adhesive bandages (IP#1, IP#2, IP#3, IP#4), and 8) no treatment (uncovered, negative control). Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandages were not left on after a composite healing score of 8 was achieved.
11357186|NCT03763175|EG000|Reported Event|SYN-010 21 mg|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (21 mg PO QD). Study activities will be the same across all three arms.~SYN-010 21 mg: 21 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11357187|NCT03763175|EG001|Reported Event|SYN-010 42 mg|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (42 mg PO QD). Study activities will be the same across all three arms.~SYN-010 42 mg: 42 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11357188|NCT03763175|EG002|Reported Event|Placebo|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of placebo. Study activities will be the same across all three arms.~Placebo: A placebo will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11357189|NCT03763058|BG000|Baseline|Music Intervention|"The music intervention is administered via a smartphone- (and computer-) based application called Music Care.~Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the U technique designed to gradually relax the listener. The U technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.~Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month."
11357190|NCT03763058|FG000|Participant Flow|Music Intervention|"The music intervention is administered via a smartphone- (and computer-) based application called Music Care.~Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the U technique designed to gradually relax the listener. The U technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.~Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month."
11166373|NCT01973595|EG000|Reported Event|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
11166374|NCT01973595|EG001|Reported Event|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
11350288|NCT04039867|BG000|Baseline|Oxaliplatin With Gemcitabine|"Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.~Oxaliplatin with Gemcitabine: Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin."
11350289|NCT04039867|FG000|Participant Flow|Oxaliplatin With Gemcitabine|"Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.~Oxaliplatin with Gemcitabine: Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin."
11350290|NCT04039867|OG000|Outcome|Oxaliplatin With Gemcitabine|"Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.~Oxaliplatin with Gemcitabine: Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin."
11350291|NCT04039867|EG000|Reported Event|Oxaliplatin With Gemcitabine|"Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.~Oxaliplatin with Gemcitabine: Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin."
11350292|NCT04039412|BG000|Baseline|(1) Reverse Hybrid Regimen|"clarithromycin 500mg bid, omeprazole 20mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20mg bid, and amoxicillin 1gm bid in the 2nd week.~Reverse hybrid regimen: one-step two-phase (quadruple-dual) treatment"
11350293|NCT04039412|BG001|Baseline|(2) Hybrid Regimen|"omeprazole 20mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week.~Hybrid regimen: two-step (dual-quadruple) treatment"
11350294|NCT04039412|BG002|Baseline|(3) Levofloxacin Quadruple Regimen|"levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days. (LOAD)~Levofloxacin quadruple regimen: non-Clarithromycin non-Bismuth quadruple therapy"
11350295|NCT04039412|BG003|Baseline|Total|Total of all reporting groups
11350296|NCT04039412|FG000|Participant Flow|(1) Reverse Hybrid Regimen|"clarithromycin 500mg bid, omeprazole 20mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20mg bid, and amoxicillin 1gm bid in the 2nd week.~Reverse hybrid regimen: one-step two-phase (quadruple-dual) treatment"
11350297|NCT04039412|FG001|Participant Flow|(2) Hybrid Regimen|"omeprazole 20mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week.~Hybrid regimen: two-step (dual-quadruple) treatment"
11350298|NCT04039412|FG002|Participant Flow|(3) Levofloxacin Quadruple Regimen|"levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days. (LOAD)~Levofloxacin quadruple regimen: non-Clarithromycin non-Bismuth quadruple therapy"
11350299|NCT04039412|OG000|Outcome|(1) Reverse Hybrid Regimen|clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20 mg bid, and amoxicillin 1gm bid in the 2nd week
11350300|NCT04039412|OG001|Outcome|(2) Hybrid Regimen|omeprazole 20 mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week
11350301|NCT04039412|OG002|Outcome|(3) Levofloxacin Quadruple Regimen|levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
11350302|NCT04039412|OG000|Outcome|(1) Reverse Hybrid Regimen|109 participants in per-protocol analysis (99.1%)
11350303|NCT04039412|OG001|Outcome|(2) Hybrid Regimen|107 participants in per-protocol analysis (97.3%)
11350304|NCT04039412|OG002|Outcome|(3) Levofloxacin Quadruple Regimen|108 participants in per-protocol analysis (98.2%)
11350305|NCT04039412|EG000|Reported Event|(1) Reverse Hybrid Regimen|clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20 mg bid, and amoxicillin 1gm bid in the 2nd week
11350306|NCT04039412|EG001|Reported Event|(2) Hybrid Regimen|omeprazole 20 mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week
11350307|NCT04039412|EG002|Reported Event|(3) Levofloxacin Quadruple Regimen|levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
11350308|NCT04035161|BG000|Baseline|All Study Participants|All Participants Who Completed Evaluations
11350309|NCT04035161|FG000|Participant Flow|All Study Participants|Study Participants that were treated
11350310|NCT04035161|OG000|Outcome|Investigational Product|Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol
11350311|NCT04035161|OG001|Outcome|Reference Standard|1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick
11350312|NCT04035161|OG001|Outcome|Active Control|ChloraPrep® SEPP® clear applicator- 2% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol
11350313|NCT04035161|OG002|Outcome|Negative Control|1.75mL 0.9% Normal saline applied with a single Swabstick
11350314|NCT04035161|EG000|Reported Event|Investigational Product|Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol
11350315|NCT04035161|EG001|Reported Event|Reference Standard|1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick
11350316|NCT04035161|EG002|Reported Event|Active Control|ChloraPrep® SEPP® clear applicator- 2% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol
11350317|NCT04035161|EG003|Reported Event|Negative Control|1.75mL 0.9% Normal saline applied with a single Swabstick
11350318|NCT04029519|BG000|Baseline|PN40082|"All subjects in this study will receive one open-label treatment with PN40082.~PN40082: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w."
11350319|NCT04029519|FG000|Participant Flow|PN40082|All subjects in this study will receive one open-label treatment with PN40082.
11350320|NCT04029519|OG000|Outcome|PN40082|"All subjects in this study will receive one open-label treatment with PN40082.~PN40082: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w."
11350321|NCT04029519|EG000|Reported Event|PN40082|"All subjects in this study will receive one open-label treatment with PN40082.~PN40082: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w."
11350322|NCT04039919|BG000|Baseline|Part A: Treatment Sequence A|Participants received ethanol 0.6 grams per liter (g/L) intravenous (IV) infusion on Day 1 during Treatment Period 1 (TP1), followed by placebo (for ethanol IV infusion) on Day 1 during TP2, then padsevonil (PSL) oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.
11350323|NCT04039919|BG001|Baseline|Part A: Treatment Sequence B|Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1, followed by placebo (for ethanol IV infusion) on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 5 during TP4, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.
11350324|NCT04039919|BG002|Baseline|Part A: Treatment Sequence C|Participants received placebo (for ethanol IV infusion) on Day 1 during TP1, followed by ethanol 0.6 g/L IV infusion on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.
11350325|NCT04039919|BG003|Baseline|Part A: Treatment Sequence D|Participants received placebo (for ethanol IV infusion) on Day 1 during TP1, followed by ethanol 0.6 g/L IV infusion on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 5 during TP4, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.
11350326|NCT04039919|BG004|Baseline|Part B: Cannabidiol (CBD)|Participants received a single oral dose of CBD 10 milligrams per kilogram (mg/kg) solution, under fasted condition on Day 1 during TP1.
11350327|NCT04039919|BG005|Baseline|Total Title|
11350328|NCT04039919|FG000|Participant Flow|Part A: Treatment Sequence A|Participants received ethanol 0.6 grams per liter (g/L) intravenous (IV) infusion on Day 1 during Treatment Period 1 (TP1), followed by placebo (for ethanol IV infusion) on Day 1 during TP2, then padsevonil (PSL) oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.
11350329|NCT04039919|FG001|Participant Flow|Part A: Treatment Sequence B|Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1, followed by placebo (for ethanol IV infusion) on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 5 during TP4, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.
11350330|NCT04039919|FG002|Participant Flow|Part A: Treatment Sequence C|Participants received placebo (for ethanol IV infusion) on Day 1 during TP1, followed by ethanol 0.6 g/L IV infusion on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.
11350331|NCT04039919|FG003|Participant Flow|Part A: Treatment Sequence D|Participants received placebo (for ethanol IV infusion) on Day 1 during TP1, followed by ethanol 0.6 g/L IV infusion on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 5 during TP4, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.
11350332|NCT04039919|FG004|Participant Flow|Part B: Cannabidiol (CBD)|Participants received a single oral dose of CBD 10 milligrams per kilogram (mg/kg) solution, under fasted condition on Day 1 during TP1.
11350333|NCT04039919|OG000|Outcome|Part A: Ethanol (FAS)|Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the FAS.
10887830|NCT00503113|BG000|Baseline|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
11350334|NCT04039919|OG001|Outcome|Part A: Placebo (FAS)|Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Full Analysis Set (FAS).
11350335|NCT04039919|OG000|Outcome|Part A: PSL + Ethanol (FAS)|Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the FAS.
11350336|NCT04039919|OG001|Outcome|Part A: PSL + Placebo (FAS)|Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the FAS.
11350337|NCT04039919|OG000|Outcome|Part B: PSL|Zero participants received PSL during Part B because the study was terminated.
11350338|NCT04039919|OG000|Outcome|Part B: CBD (PKS)|Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the PKS.
11350339|NCT04039919|OG000|Outcome|Part A: Ethanol (PKS)|Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Pharmacokinetic Set (PKS).
11350340|NCT04039919|OG000|Outcome|Part A: PSL + Ethanol (PKS)|Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the PKS.
11350341|NCT04039919|OG001|Outcome|Part A: PSL + Placebo (PKS)|Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the PKS.
11350342|NCT04039919|OG000|Outcome|Part B: CBD (FAS)|Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the FAS.
11350343|NCT04039919|OG000|Outcome|Part A: Pre-treatment (SS)|Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part A. Participants formed SS.
11350344|NCT04039919|OG001|Outcome|Part A: Placebo (SS)|Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Safety Set (SS).
11350345|NCT04039919|OG002|Outcome|Part A: Ethanol (SS)|Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the SS.
11350346|NCT04039919|OG003|Outcome|Part A: PSL (SS)|Participants received PSL 100 mg or 200 mg oral tablets BID on Day 1 to 4 during TP3 in Treatment Sequence A, B, C and D. Participants formed the SS.
11350347|NCT04039919|OG004|Outcome|Part A: PSL + Ethanol (SS)|Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the SS.
11350348|NCT04039919|OG005|Outcome|Part A: PSL + Placebo (SS)|Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the SS.
11350349|NCT04039919|OG000|Outcome|Part B: Pre-treatment (SS)|Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part B. Participants formed SS.
11350350|NCT04039919|OG001|Outcome|Part B: CBD (SS)|Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the SS.
11350351|NCT04039919|OG000|Outcome|Part A: Placebo (SS)|Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Safety Set (SS).
11350352|NCT04039919|OG001|Outcome|Part A: Ethanol (SS)|Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the SS.
11350353|NCT04039919|OG002|Outcome|Part A: PSL (SS)|Participants received PSL 100 mg or 200 mg oral tablets BID on Day 1 to 4 during TP3 in Treatment Sequence A, B, C and D. Participants formed the SS.
11350354|NCT04039919|OG003|Outcome|Part A: PSL + Ethanol (SS)|Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the SS.
11350355|NCT04039919|OG004|Outcome|Part A: PSL + Placebo (SS)|Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the SS.
11350356|NCT04039919|OG000|Outcome|Part B: CBD (SS)|Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the SS.
11350357|NCT04039919|EG000|Reported Event|Part A: Pre-treatment (SS)|Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part A. Participants formed SS.
11350358|NCT04039919|EG001|Reported Event|Part A: Placebo (SS)|Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Safety Set (SS).
11350359|NCT04039919|EG002|Reported Event|Part A: Ethanol (SS)|Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the SS.
11350360|NCT04039919|EG003|Reported Event|Part A: PSL (SS)|Participants received PSL 100 mg or 200 mg oral tablets BID on Day 1 to 4 during TP3 in Treatment Sequence A, B, C and D. Participants formed the SS.
11350361|NCT04039919|EG004|Reported Event|Part A: PSL + Ethanol (SS)|Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the SS.
11350362|NCT04039919|EG005|Reported Event|Part A: PSL + Placebo (SS)|Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the SS.
11350363|NCT04039919|EG006|Reported Event|Part B: Pre-treatment (SS)|Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part B. Participants formed SS.
11350364|NCT04039919|EG007|Reported Event|Part B: CBD (SS)|Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the SS.
11350365|NCT04037969|BG000|Baseline|Nesofilcon A/Delefilcon A|"Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye.~Nesofilcon A: Hydrogel contact lens for daily wear"
11350366|NCT04037969|BG001|Baseline|Delefilcon A/Nesofilcon A|"Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye.~Delefilcon A: Silicone hydrogel contact lens for daily wear"
11350367|NCT04037969|BG002|Baseline|Total|Total of all reporting groups
11350368|NCT04037969|FG000|Participant Flow|Nesofilcon A/Delefilcon A|"Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye.~Nesofilcon A: Hydrogel contact lens for daily wear"
11350369|NCT04037969|FG001|Participant Flow|Delefilcon A/Nesofilcon A|"Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye.~Delefilcon A: Silicone hydrogel contact lens for daily wear"
11350370|NCT04037969|OG000|Outcome|Full Group|"Delefilcon A was worn in a randomly assigned eye and Nesofilcon A was worn in the fellow eye.~Nesofilcon A: Hydrogel contact lens for daily wear~Delefilcon A: Silicone hydrogel contact lens for daily wear"
11350371|NCT04037969|EG000|Reported Event|Nesofilcon A/Delefilcon A|"Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye.~Nesofilcon A: Hydrogel contact lens for daily wear"
11350372|NCT04037969|EG001|Reported Event|Delefilcon A/Nesofilcon A|"Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye.~Delefilcon A: Silicone hydrogel contact lens for daily wear"
11350373|NCT04037865|BG000|Baseline|Severe Renal Impairment|Participants with severe renal impairment were included to receive oral PF-06651600 50 mg daily for up to 10 days from Day 1 to Day 10. Stages of renal impairment were based on Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Chronic Kidney Disease.
11174064|NCT02019563|EG000|Reported Event|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
11350374|NCT04037865|FG000|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment were included to receive oral PF-06651600 50 mg daily for up to 10 days from Day 1 to Day 10. Stages of renal impairment were based on Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Chronic Kidney Disease.
11350375|NCT04037865|OG000|Outcome|Severe Renal Impairment|Participants with severe renal impairment were included to receive oral PF-06651600 50 mg daily for up to 10 days from Day 1 to Day 10. Stages of renal impairment were based on Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Chronic Kidney Disease.
11350376|NCT04037865|EG000|Reported Event|Severe Renal Impairment|Participants with severe renal impairment were included to receive oral PF-06651600 50 mg daily for up to 10 days from Day 1 to Day 10. Stages of renal impairment were based on Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Chronic Kidney Disease.
11350377|NCT04037865|EG001|Reported Event|Total|All participants.
11350378|NCT04037748|BG000|Baseline|First Puran T4®, Then Eutirox®|Participants received single oral dose of Puran T4® 600 micrograms (mcg) (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Eutirox® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 2 under fasting conditions. A wash-out period of 70 days was maintained between the Treatment Periods 1 and 2.
10887831|NCT00503113|BG001|Baseline|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
11350379|NCT04037748|BG001|Baseline|First Eutirox®, Then Puran T4®|Participants received single oral dose of Eutirox® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Puran T4® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 2 under fasting conditions. A wash-out period of 70 days was maintained between the Treatment Periods 1 and 2.
11350380|NCT04037748|BG002|Baseline|Total|Total of all reporting groups
11350381|NCT04037748|FG000|Participant Flow|First Puran T4®, Then Eutirox®|Participants received single oral dose of Puran T4® 600 micrograms (mcg) (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Eutirox® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 2 under fasting conditions. A wash-out period of 70 days was maintained between the Treatment Periods 1 and 2.
11350382|NCT04037748|FG001|Participant Flow|First Eutirox®, Then Puran T4®|Participants received single oral dose of Eutirox® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Puran T4® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 2 under fasting conditions. A wash-out period of 70 days was maintained between the Treatment Periods 1 and 2.
11350383|NCT04037748|OG000|Outcome|Puran T4®|Participants who received a single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.
11350384|NCT04037748|OG001|Outcome|Eutirox®|Participants who received a single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.
11350385|NCT04037748|EG000|Reported Event|Puran T4|Participants who received a single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.
11350386|NCT04037748|EG001|Reported Event|Eutirox®|Participants who received a single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.
11350387|NCT04036838|BG000|Baseline|Indication for H.Pylori Testing|"Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.~PyloPlus UBT System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.~Histology: Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist~Rapid Urease Test: Biopsy specimen obtained and placed onto Rapid Urease Test~H.pylori Culture: Biopsy specimen obtained and sent to lab for culture analysis"
11350388|NCT04036838|FG000|Participant Flow|Indication for H.Pylori Testing|"Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.~PyloPlus UBT System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.~Histology: Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist~Rapid Urease Test: Biopsy specimen obtained and placed onto Rapid Urease Test~H.pylori Culture: Biopsy specimen obtained and sent to lab for culture analysis"
11350389|NCT04036838|OG000|Outcome|Indication for H.Pylori Testing|"Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.~PyloPlus UBT System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.~Histology: Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist~Rapid Urease Test: Biopsy specimen obtained and placed onto Rapid Urease Test~H.pylori Culture: Biopsy specimen obtained and sent to lab for culture analysis"
11350390|NCT04036838|EG000|Reported Event|Indication for H.Pylori Testing|"Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.~PyloPlus UBT System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.~Histology: Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist~Rapid Urease Test: Biopsy specimen obtained and placed onto Rapid Urease Test~H.pylori Culture: Biopsy specimen obtained and sent to lab for culture analysis"
10887832|NCT00503113|BG002|Baseline|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
11174065|NCT02019563|EG001|Reported Event|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
11350391|NCT04034121|BG000|Baseline|DESolve Cx|"DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System~The DESolve Cx Novolimus Eluting BCSS is comprised of four main components: the Poly-L-Lactic Acid-based polymer (PLLA) stent coated with a PLLA-based polymer-drug matrix containing the anti-proliferative drug Novolimus."
11350392|NCT04034121|FG000|Participant Flow|DESolve Cx|"DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System~The DESolve Cx Novolimus Eluting BCSS is comprised of four main components: the Poly-L-Lactic Acid-based polymer (PLLA) stent coated with a PLLA-based polymer-drug matrix containing the anti-proliferative drug Novolimus."
11350393|NCT04034121|OG000|Outcome|DESolve Cx|"DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System~DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention"
11350394|NCT04034121|OG000|Outcome|DESolve Cx|"DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System~The DESolve Cx Novolimus Eluting BCSS is comprised of four main components: the Poly-L-Lactic Acid-based polymer (PLLA) stent coated with a PLLA-based polymer-drug matrix containing the anti-proliferative drug Novolimus."
11350395|NCT04034121|EG000|Reported Event|DESolve Cx|"DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System~DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention"
10887833|NCT00503113|BG003|Baseline|Total|Total of all reporting groups
10887834|NCT00503113|FG000|Participant Flow|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
10887835|NCT00503113|FG001|Participant Flow|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
10887836|NCT00503113|FG002|Participant Flow|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
10887837|NCT00503113|OG000|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
11350396|NCT04027686|BG000|Baseline|Periodontal Sites Assigned to SRP + Adjunctive Laser Therapy or SRP Alone|Enrolled participants each had multiple periodontal sites randomly assigned to receive scaling and root planing as conventional non-surgical periodontal therapy, or Laser therapy as an adjunct to scaling and root planing.
11350397|NCT04027686|BG001|Baseline|Pilot Procedure Arm|Preliminary enrollment of individuals to pilot-test the protocol
11350398|NCT04027686|BG002|Baseline|Total|Total of all reporting groups
11350399|NCT04027686|FG000|Participant Flow|Periodontal Sites Assigned to SRP or SRP + Adjunctive Laser Therapy|Each participant had one or more periodontal sites randomly assigned to scaling and root planing only (Standard of Care) or to Laser therapy in addition to scaling and root planing
11350400|NCT04027686|FG001|Participant Flow|Pilot Procedure Arm|Preliminary enrollment of individuals to pilot-test the protocol
11350401|NCT04027686|OG000|Outcome|SRP + Adjunctive Laser Therapy|Laser therapy used as an adjunct to scaling and root planing
11350402|NCT04027686|OG001|Outcome|SRP Alone|Scaling and root planing used as conventional non-surgical periodontal therapy
11350403|NCT04027686|OG002|Outcome|Pilot Procedure Arm|Preliminary enrollment of individuals to pilot-test the protocol
11350404|NCT04027686|OG000|Outcome|SRP + Adjunctive Laser Therapy|"Laser therapy used as an adjunct to scaling and root planing~Laser Therapy: Adjunctive application of laser therapy in the periodontal pocket~Non-surgical Scaling and Root Planing: Scaling to remove calculus deposits and root planing to smooth root surfaces"
11350405|NCT04027686|OG001|Outcome|SRP Alone|"Scaling and root planing used as conventional non-surgical periodontal therapy~Non-surgical Scaling and Root Planing: Scaling to remove calculus deposits and root planing to smooth root surfaces"
11350406|NCT04027686|EG000|Reported Event|SRP + Adjunctive Laser Therapy|"Laser therapy used as an adjunct to scaling and root planing~Following patient identification, review of health history and checking vital signs, local anesthesia is applied to the area.~Laser Therapy: Adjunctive application of laser therapy to de-epithelialize the outer surface of gingival margin and within the periodontal pocket. The inner pocket epithelium is removed from the free gingival margin to the level equal with the pocket depth.~Non-surgical Scaling and Root Planing: Scaling with ultrasonic scaler and hand instruments to remove calculus deposits and root planing to smooth root surfaces.~Laser Therapy: Following non-surgical scaling and root planing, laser is used to remove smear layer from root surface, to completely remove pocket lining and to degranulate the pocket. Laser is used to decorticate and stimulate the bone at the base of defect. Finally, the laser is used to remove the residual debris while inducing blood coagulation.~The surgical site is compressed with moistened 2 x 2 gauze using finger pressure for several minutes to achieve hemostasis."
11174066|NCT02019602|BG000|Baseline|SS-M|This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery.
11350407|NCT04027686|EG001|Reported Event|SRP Alone|"Scaling and root planing used as conventional non-surgical periodontal therapy~Following patient identification, review of health history and checking vital signs, local anesthesia is applied to the area.~Non-surgical Scaling and Root Planing: Scaling with ultrasonic scaler and hand instruments to remove calculus deposits and root planing to smooth root surfaces. Pockets were flushed with ultrasonic scaler."
11350408|NCT04027686|EG002|Reported Event|Pilot Procedure Arm|Preliminary enrollment of individuals to pilot-test the protocol
11350409|NCT04022694|BG000|Baseline|Baseline for Calorie/Control Poster|We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.
11350410|NCT04022694|BG001|Baseline|Baseline for SSB Warning and Non-SSB Promotion Poster|We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the treatment school.
11350411|NCT04022694|BG002|Baseline|Total|Total of all reporting groups
11350412|NCT04022694|FG000|Participant Flow|Baseline for Calorie/Control Poster|We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.
11350413|NCT04022694|FG001|Participant Flow|Baseline for SSB Warning and Non-SSB Promotion Poster|We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
11350414|NCT04022694|FG002|Participant Flow|Calorie/Control Poster|"This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. It will simply state that those beverages are sold in the school store.~Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages"
11350415|NCT04022694|FG003|Participant Flow|SSB Warning and Non-SSB Promotion Poster|"This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. In addition, the message will state that SSBs are high in sugar and should be avoided, while low or no sugar beverages are healthier options and should be chosen.~Exposure to beverage health information: Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information~Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages"
11350416|NCT04022694|OG000|Outcome|Baseline for Calorie/Control Poster|We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.
11350417|NCT04022694|OG001|Outcome|Baseline for SSB Warning and Non-SSB Promotion Poster|We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
11350418|NCT04022694|OG002|Outcome|Calorie/Control Poster|"This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. It will simply state that those beverages are sold in the school store.~Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages"
11350419|NCT04022694|OG003|Outcome|SSB Warning and Non-SSB Promotion Poster|"This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. In addition, the message will state that SSBs are high in sugar and should be avoided, while low or no sugar beverages are healthier options and should be chosen.~Exposure to beverage health information: Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information~Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages"
11350420|NCT04022694|OG000|Outcome|Calorie/Control Poster|"This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. It will simply state that those beverages are sold in the school store.~Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages"
11350421|NCT04022694|OG001|Outcome|SSB Warning and Non-SSB Promotion Poster|"This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. In addition, the message will state that SSBs are high in sugar and should be avoided, while low or no sugar beverages are healthier options and should be chosen.~Exposure to beverage health information: Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information~Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages"
11350422|NCT04022694|EG000|Reported Event|Baseline for Calorie/Control Poster|We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.
11350423|NCT04022694|EG001|Reported Event|Baseline for SSB Warning and Non-SSB Promotion Poster|We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
11350424|NCT04022694|EG002|Reported Event|Calorie/Control Poster|"This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. It will simply state that those beverages are sold in the school store.~Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages"
11350425|NCT04022694|EG003|Reported Event|SSB Warning and Non-SSB Promotion Poster|"This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. In addition, the message will state that SSBs are high in sugar and should be avoided, while low or no sugar beverages are healthier options and should be chosen.~Exposure to beverage health information: Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information~Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages"
11350426|NCT04036110|BG000|Baseline|Intervention 1 (500 mg)|Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months
11350427|NCT04036110|BG001|Baseline|Intervention 2 (1000 mg)|Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months
11350428|NCT04036110|BG002|Baseline|Control (Placebo)|Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
11089371|NCT01523587|FG000|Participant Flow|Afatinib|Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
11350429|NCT04036110|BG003|Baseline|Total|Total of all reporting groups
11350430|NCT04036110|FG000|Participant Flow|Intervention 1 (500 mg)|Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months
11350431|NCT04036110|FG001|Participant Flow|Intervention 2 (1000 mg)|Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months
11350432|NCT04036110|FG002|Participant Flow|Control (Placebo)|Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
11350433|NCT04036110|OG000|Outcome|Intervention 1 (500 mg)|Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months
11350434|NCT04036110|OG001|Outcome|Intervention 2 (1000 mg)|Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months
11350435|NCT04036110|OG002|Outcome|Control (Placebo)|Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
11350436|NCT04036110|EG000|Reported Event|Intervention 1 (500 mg)|Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months
11350437|NCT04036110|EG001|Reported Event|Intervention 2 (1000 mg)|Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months
11350438|NCT04036110|EG002|Reported Event|Control (Placebo)|Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
11350439|NCT04035694|BG000|Baseline|Intervention|"Participants will receive access to Media Aware.~Media Aware Sexual Health - High School: Media Aware is an online media literacy and sexual health education program developed for high school students that addresses the influence of media on sexual behaviors explicitly using established message processing theory. The program consists of 4 self-paced modules each with two to three lessons. Broadly, the modules cover healthy and unhealthy relationships, sexually transmitted infections, consent, substance use, pregnancy, protection and contraception, and communication between adolescents and their partners, parents, or health providers. Users also learn media literacy skills including message deconstruction to help examine the truth behind media messages."
11089372|NCT01523587|FG001|Participant Flow|Erlotinib|Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
11174067|NCT02019602|BG001|Baseline|SS-I|This arm consisted of all infants born to mothers in the SS-M group.
11174068|NCT02019602|BG002|Baseline|Total Title|
11350440|NCT04035694|BG001|Baseline|Delayed-Intervention Control|Participants will receive their regular health education programming not related to sexual health education or media literacy education.
11350441|NCT04035694|BG002|Baseline|Total|Total of all reporting groups
11350442|NCT04035694|FG000|Participant Flow|Intervention|"Participants will receive access to Media Aware.~Media Aware Sexual Health - High School: Media Aware is an online media literacy and sexual health education program developed for high school students that addresses the influence of media on sexual behaviors explicitly using established message processing theory. The program consists of 4 self-paced modules each with two to three lessons. Broadly, the modules cover healthy and unhealthy relationships, sexually transmitted infections, consent, substance use, pregnancy, protection and contraception, and communication between adolescents and their partners, parents, or health providers. Users also learn media literacy skills including message deconstruction to help examine the truth behind media messages."
11350443|NCT04035694|FG001|Participant Flow|Delayed-Intervention Control|Participants will receive their regular health education programming not related to sexual health education or media literacy education.
11350444|NCT04035694|OG000|Outcome|Intervention|"Participants will receive access to Media Aware.~Media Aware Sexual Health - High School: Media Aware is an online media literacy and sexual health education program developed for high school students that addresses the influence of media on sexual behaviors explicitly using established message processing theory. The program consists of 4 self-paced modules each with two to three lessons. Broadly, the modules cover healthy and unhealthy relationships, sexually transmitted infections, consent, substance use, pregnancy, protection and contraception, and communication between adolescents and their partners, parents, or health providers. Users also learn media literacy skills including message deconstruction to help examine the truth behind media messages."
11350445|NCT04035694|OG001|Outcome|Delayed-Intervention Control|Participants will receive their regular health education programming not related to sexual health education or media literacy education.
11350446|NCT04035694|EG000|Reported Event|Intervention|"Participants will receive access to Media Aware.~Media Aware Sexual Health - High School: Media Aware is an online media literacy and sexual health education program developed for high school students that addresses the influence of media on sexual behaviors explicitly using established message processing theory. The program consists of 4 self-paced modules each with two to three lessons. Broadly, the modules cover healthy and unhealthy relationships, sexually transmitted infections, consent, substance use, pregnancy, protection and contraception, and communication between adolescents and their partners, parents, or health providers. Users also learn media literacy skills including message deconstruction to help examine the truth behind media messages."
11350447|NCT04035694|EG001|Reported Event|Delayed-Intervention Control|Participants will receive their regular health education programming not related to sexual health education or media literacy education.
11350448|NCT04035577|BG000|Baseline|Extended Usability of a Mobile Self-help Intervention|"Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks~Mobile self-help intervention: During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day"
11350449|NCT04035577|FG000|Participant Flow|Extended Usability of a Mobile Self-help Intervention|"Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks~Mobile self-help intervention: During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day"
11350450|NCT04035577|OG000|Outcome|Lower Symptom|Participants who had PHQ-9 and GAD-7 scores under 10 at baseline
11350451|NCT04035577|OG001|Outcome|Higher Symptom|Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
11350452|NCT04035577|OG000|Outcome|Extended Usability of a Mobile Self-help Intervention|"Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks~Mobile self-help intervention: During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day"
11174069|NCT02019602|FG000|Participant Flow|SS-M|This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery.
11350453|NCT04035577|EG000|Reported Event|Extended Usability of a Mobile Self-help Intervention|"Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks~Mobile self-help intervention: During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day"
11350454|NCT04035564|BG000|Baseline|Sodium < 1mEq/kg/Day|"Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one~Sodium < 1mEq/kg/day: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1"
11350455|NCT04035564|BG001|Baseline|Sodium 5mEq/kg/Day|"Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one~Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1"
11350456|NCT04035564|BG002|Baseline|Total|Total of all reporting groups
11350457|NCT04035564|FG000|Participant Flow|Sodium < 1mEq/kg/Day|"Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one~Sodium < 1mEq/kg/day: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1"
11350458|NCT04035564|FG001|Participant Flow|Sodium 5mEq/kg/Day|"Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one~Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1"
11350459|NCT04035564|OG000|Outcome|Sodium < 1mEq/kg/Day|"Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one~Sodium < 1mEq/kg/day: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1"
11350460|NCT04035564|OG001|Outcome|Sodium 5mEq/kg/Day|"Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one~Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1"
11350461|NCT04035564|EG000|Reported Event|Sodium < 1mEq/kg/Day|"Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one~Sodium < 1mEq/kg/day: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1"
11350462|NCT04035564|EG001|Reported Event|Sodium 5mEq/kg/Day|"Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one~Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1"
11350463|NCT04032977|BG000|Baseline|PN40082|Test device: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w
11350464|NCT04032977|BG001|Baseline|Restylane Silk|Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
11350465|NCT04032977|BG002|Baseline|Total|Total of all reporting groups
11350466|NCT04032977|FG000|Participant Flow|PN40082|Test device: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w
11350467|NCT04032977|FG001|Participant Flow|Restylane Silk|Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
11350468|NCT04032977|OG000|Outcome|PN40082|Test device: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w
11350469|NCT04032977|OG001|Outcome|Restylane Silk|Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
11350470|NCT04032977|EG000|Reported Event|PN40082|Test device: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w
11350471|NCT04032977|EG001|Reported Event|Restylane Silk|Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
11350472|NCT04032652|BG000|Baseline|1200 mg Asacol Once Daily for 1 Week|"Rectal dialysis will be done after 1 week on 1200 mg asacol~Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels"
11350473|NCT04032652|BG001|Baseline|2400 mg Asacol Once Daily for 1 Week|"Rectal dialysis will be done after 1 week on 2400 mg asacol~Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels"
11350474|NCT04032652|BG002|Baseline|Total|Total of all reporting groups
11350475|NCT04032652|FG000|Participant Flow|1200 mg Asacol Once Daily for 1 Week|"Rectal dialysis will be done after 1 week on 1200 mg asacol~Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels"
11350476|NCT04032652|FG001|Participant Flow|2400 mg Asacol Once Daily for 1 Week|"Rectal dialysis will be done after 1 week on 2400 mg asacol~Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels"
11350477|NCT04032652|OG000|Outcome|1200 mg Asacol Once Daily for 1 Week|"Rectal dialysis will be done after 1 week on 1200 mg asacol~Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels"
11350478|NCT04032652|OG001|Outcome|2400 mg Asacol Once Daily for 1 Week|"Rectal dialysis will be done after 1 week on 2400 mg asacol~Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels"
11350479|NCT04032652|EG000|Reported Event|1200 mg Asacol Once Daily for 1 Week|"Rectal dialysis will be done after 1 week on 1200 mg asacol~Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels"
11350480|NCT04032652|EG001|Reported Event|2400 mg Asacol Once Daily for 1 Week|"Rectal dialysis will be done after 1 week on 2400 mg asacol~Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels"
11174070|NCT02019602|FG001|Participant Flow|SS-I|This arm consisted of all infants born to mothers in the SS-M group.
11350481|NCT04024501|BG000|Baseline|Overall-All Subjects|"All subjects were randomized into 5-period, 5-treatment, crossover study to receive a single oral dose of 12 mg verinurad:~Treatment 1: 1 x 12 mg verinurad ER8 capsule formulation, fasted.~Treatment 2: 2 x 6 mg verinurad A-capsule formulation, fasted.~Treatment 3: 2 x 6 mg verinurad A-capsule formulation, fed.~Treatment 4: 2 x 6 mg verinurad B-capsule formulation, fasted.~Treatment 5: 2 x 6 mg verinurad B-capsule formulation, fed."
11350482|NCT04024501|FG000|Participant Flow|Overall-All Subjects|"All subjects were randomized into 5-period, 5-treatment, crossover study to receive a single oral dose of 12 mg verinurad:~Treatment 1: 1 x 12 mg verinurad ER8 capsule formulation, fasted.~Treatment 2: 2 x 6 mg verinurad A-capsule formulation, fasted.~Treatment 3: 2 x 6 mg verinurad A-capsule formulation, fed.~Treatment 4: 2 x 6 mg verinurad B-capsule formulation, fasted.~Treatment 5: 2 x 6 mg verinurad B-capsule formulation, fed."
11350483|NCT04024501|OG000|Outcome|Treatment 1: 1 x 12 mg ER8 Capsule Fasted|During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
11350484|NCT04024501|OG001|Outcome|Treatment 2: 2 x 6 mg A-capsule Fasted|During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
11350485|NCT04024501|OG002|Outcome|Treatment 3: 2 x 6 mg A-capsule Fed|During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
11350486|NCT04024501|OG003|Outcome|Treatment 4: 2 x 6 mg B-capsule Fasted|During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
11350487|NCT04024501|OG004|Outcome|Treatment 5: 2 x 6 mg B-capsule Fed|During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
11350488|NCT04024501|EG000|Reported Event|Treatment 1: 1 x 12 mg ER8 Capsule Fasted|During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
11350489|NCT04024501|EG001|Reported Event|Treatment 2: 2 x 6 mg A-capsule Fasted|During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
11350490|NCT04024501|EG002|Reported Event|Treatment 3: 2 x 6 mg A-capsule Fed|During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
11350491|NCT04024501|EG003|Reported Event|Treatment 4: 2 x 6 mg B-capsule Fasted|During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
11350492|NCT04024501|EG004|Reported Event|Treatment 5: 2 x 6 mg B-capsule Fed|During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
11350493|NCT04032613|BG000|Baseline|Vascular Access QI Program Patient Participants|"All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.~Vascular Access Navigation and Education Quality Improvement Program: A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program."
11350494|NCT04032613|BG001|Baseline|Vascular Access QI Program Provider/Personnel Participants|"All provider/personnel participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.~Vascular Access Navigation and Education Quality Improvement Program: A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program."
11350495|NCT04032613|BG002|Baseline|Total|Total of all reporting groups
11350496|NCT04032613|FG000|Participant Flow|Vascular Access QI Program Patient Participants|"All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement (QI) Program.~Vascular Access Navigation and Education Quality Improvement Program: A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program."
11350497|NCT04032613|FG001|Participant Flow|Vascular Access QI Program Provider/Personnel Participants|"All provider/personnel participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.~Vascular Access Navigation and Education Quality Improvement Program: A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program."
11350498|NCT04032613|OG000|Outcome|Vascular Access QI Program Patient Participants|"All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.~Vascular Access Navigation and Education Quality Improvement Program: A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program."
11350499|NCT04032613|OG000|Outcome|Vascular Access QI Program Provider/Personnel Participants|"All provider/personnel participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.~Vascular Access Navigation and Education Quality Improvement Program: A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program."
11350500|NCT04032613|EG000|Reported Event|Vascular Access QI Program Patient Participants|"All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.~Vascular Access Navigation and Education Quality Improvement Program: A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program."
11350501|NCT04032613|EG001|Reported Event|Vascular Access QI Program Provider/Personnel Participants|"All provider/personnel participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.~Vascular Access Navigation and Education Quality Improvement Program: A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program."
11350502|NCT04032171|BG000|Baseline|Evobrutinib + Avonex® Matched Placebo|Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
11350503|NCT04032171|BG001|Baseline|Avonex® + Evobrutinib Matched Placebo|Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
11350504|NCT04032171|BG002|Baseline|Total|Total of all reporting groups
11350505|NCT04032171|FG000|Participant Flow|Evobrutinib + Avonex® Matched Placebo|Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
11350506|NCT04032171|FG001|Participant Flow|Avonex® + Evobrutinib Matched Placebo|Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
11350507|NCT04032171|OG000|Outcome|Evobrutinib + Avonex® Matched Placebo|Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
11350508|NCT04032171|OG001|Outcome|Avonex® + Evobrutinib Matched Placebo|Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
11350509|NCT04032171|EG000|Reported Event|Evobrutinib + Avonex® Matched Placebo|Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
11350510|NCT04032171|EG001|Reported Event|Avonex® + Evobrutinib Matched Placebo|Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
11350511|NCT04032158|BG000|Baseline|Experimental: Evobrutinib + Avonex® Matched Placebo|Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
11350512|NCT04032158|BG001|Baseline|Active Comparator: Avonex® + Evobrutinib Matched Placebo|Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
11350513|NCT04032158|BG002|Baseline|Total|Total of all reporting groups
11350514|NCT04032158|FG000|Participant Flow|Experimental: Evobrutinib + Avonex® Matched Placebo|Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
11350515|NCT04032158|FG001|Participant Flow|Active Comparator: Avonex® + Evobrutinib Matched Placebo|Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
11350516|NCT04032158|OG000|Outcome|Experimental: Evobrutinib + Avonex® Matched Placebo|Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
11350517|NCT04032158|OG001|Outcome|Active Comparator: Avonex® + Evobrutinib Matched Placebo|Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
11350518|NCT04032158|EG000|Reported Event|Experimental: Evobrutinib + Avonex® Matched Placebo|Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
11350519|NCT04032158|EG001|Reported Event|Active Comparator: Avonex® + Evobrutinib Matched Placebo|Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
11350520|NCT04031404|BG000|Baseline|All Participants|"Participants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2, or vice versa.~Single-pulse TMS: Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG)."
11350521|NCT04031404|FG000|Participant Flow|Glucose Drink Followed by Placebo|"Participants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2.~Single-pulse TMS: Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG)."
11350522|NCT04031404|FG001|Participant Flow|Placebo Followed by Glucose Drink|"Participants will consume the placebo (water) at session 1, then they will consume the glucose drink at session 2.~Single-pulse TMS: Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG)."
11350523|NCT04031404|OG000|Outcome|MEP After Glucose Drink|Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (~300 mL).
11350524|NCT04031404|OG001|Outcome|MEP After Placebo Drink|Participants receive TMS to motor cortex following consumption of a water control (~300 mL).
11350525|NCT04031404|OG000|Outcome|Source-localized TEP After Glucose Drink|Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (~300 mL).
11350526|NCT04031404|OG001|Outcome|Source-localized TEP After Placebo Drink|Participants receive TMS to motor cortex following consumption of a water control (~300 mL).
11350527|NCT04031404|OG000|Outcome|Alpha Asymmetry After Glucose Drink|Participants complete a resting state EEG recording following consumption of a 75 g glucose drink (~300 mL).
11350528|NCT04031404|OG001|Outcome|Alpha Asymmetry After Placebo Drink|Participants complete a resting state EEG recording following consumption of a 75 g glucose drink (~300 mL).
11350529|NCT04031404|OG000|Outcome|Midline Frontal Theta Oscillations After Glucose Drink|Participants complete a resting state EEG recording following consumption of a 75 g glucose drink (~300 mL).
11350530|NCT04031404|OG001|Outcome|Midline Frontal Theta Oscillations After Placebo Drink|Participants complete a resting state EEG recording following consumption of a 75 g glucose drink (~300 mL).
11350531|NCT04031404|OG000|Outcome|Working Memory Accuracy After Glucose Drink|Participants complete a working memory task following consumption of a 75 g glucose drink (~300 mL).
11350532|NCT04031404|OG001|Outcome|Midline Frontal Theta Oscillations After Placebo Drink|Participants complete a working memory task recording following consumption of a 75 g glucose drink (~300 mL).
11350533|NCT04031404|EG000|Reported Event|TMS-EEG After Glucose Drink|"Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (~300 mL).~During every session, participants receive single pulse TMS to the motor cortex, and complete EEG recordings and a working memory task at several time points."
11350534|NCT04031404|EG001|Reported Event|TMS-EEG After Placebo Drink|"Participants receive TMS to motor cortex following consumption of a water control drink (~300 mL).~During every session, participants receive single pulse TMS to the motor cortex, and complete EEG recordings and a working memory task at several time points."
11350535|NCT04031885|BG000|Baseline|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally BID with 500 mg fulvestrant given by IM injection on C1D1 and C1D15, then Day 1 of each subsequent cycle.
11350536|NCT04031885|BG001|Baseline|Standard Chemotherapy|Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
11350537|NCT04031885|BG002|Baseline|Total|Total of all reporting groups
11350538|NCT04031885|FG000|Participant Flow|Abemaciclib + Fulvestrant|150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.
11350539|NCT04031885|FG001|Participant Flow|Standard Chemotherapy|Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
11350540|NCT04031885|OG000|Outcome|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally BID with 500 mg fulvestrant given by IM injection C1D1 and C1D15, then Day 1 of each subsequent cycle.
11350541|NCT04031885|OG001|Outcome|Standard Chemotherapy|Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
11350542|NCT04031885|EG000|Reported Event|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally BID with 500 mg fulvestrant given by IM injection C1D1 and C1D15, then Day 1 of each subsequent cycle.
11350543|NCT04031885|EG001|Reported Event|Standard Chemotherapy|Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
11350544|NCT04018924|BG000|Baseline|All Participants|"The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound).~Control wound:~After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week.~EmoLED treated wound:~After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week.~Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)."
11350545|NCT04018924|FG000|Participant Flow|All Participants|"The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound).~Control wound:~After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week.~EmoLED treated wound:~After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week.~Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)."
11350546|NCT04018924|OG000|Outcome|All Participants|"The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound).~Control wound:~After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week.~EmoLED treated wound:~After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week.~Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)."
11350547|NCT04018924|EG000|Reported Event|All Participants|"The patient is control of themselves so all participants received both interventions; for each patient are treated and evaluated two different wounds (or two different parts of wound).~Control wound:~After standard cleansing or debridement of all wounds, the wound is covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). The medication and dressing are repeated once a week.~EmoLED treated wound:~After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week.~Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)."
11350548|NCT04015440|BG000|Baseline|HBMT|HBMT: Individual is presented with words with some letters missing and told to complete the word.
11350549|NCT04015440|BG001|Baseline|Placebo|Other Training: Alternative to HBMT training
11350550|NCT04015440|BG002|Baseline|Total|Total of all reporting groups
11174071|NCT02019602|OG000|Outcome|PK-PPS-I|This arm consisted of all infants from the SS-I analysis set who provided a CZP concentration sample at birth and had no important protocol deviations that would have impacted the primary PK analysis.
11350551|NCT04015440|FG000|Participant Flow|HBMT|HBMT: Individual is presented with words with some letters missing and told to complete the word for form non-hostile words.
11350552|NCT04015440|FG001|Participant Flow|Placebo|Alternative to HBMT training. Volunteers is presented with words with some letters missing and told to complete them with whatever comes to mind (no specific instructions).
11350553|NCT04015440|OG000|Outcome|HBMT|HBMT: Individual is presented with words with some letters missing and told to complete the word for form non-hostile words.
11350554|NCT04015440|OG001|Outcome|Placebo|Alternative to HBMT training. Volunteers is presented with words with some letters missing and told to complete them with whatever comes to mind (no specific instructions).
11350555|NCT04015440|EG000|Reported Event|HBMT|HBMT: Individual is presented with words with some letters missing and told to complete the word for form non-hostile words.
11350556|NCT04015440|EG001|Reported Event|Placebo|Alternative to HBMT training. Volunteers is presented with words with some letters missing and told to complete them with whatever comes to mind (no specific instructions).
11350557|NCT04030104|BG000|Baseline|Overall (Subjects Randomly Selected From PIONEER-01 Study)|Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data derived from PIONEER-01 for sub set of 480 cases read during Reader-02 Study.
11350558|NCT04030104|FG000|Participant Flow|Overall (Subjects Randomly Selected From PIONEER-01 Study)|Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data are for overall population only.
11350559|NCT04030104|OG000|Outcome|IUS Alone|IUS alone imaging
11350560|NCT04030104|OG001|Outcome|Imagio (IUS+OA)|IUS+OA imaging
11350561|NCT04030104|OG000|Outcome|Imagio Alone|IUS alone imaging
11350562|NCT04030104|OG000|Outcome|IUS Alone|IUS Alone Imaging
11350563|NCT04030104|EG000|Reported Event|Overall (Subjects Randomly Selected From PIONEER-01 Study)|Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, safety data are for overall population only.
11350564|NCT04029961|BG000|Baseline|Video Education|"Participants will receive video education on radiation therapy.~Video Education: Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video."
11350565|NCT04029961|BG001|Baseline|VR-based Education|"Participants will receive VR-based education on radiation therapy.~VR-based Education: Prior to their CT simulation, participants will receive education on radiation therapy in the form of an immersive VR program delivered through a head-mounted display (HMD)."
11089373|NCT01523587|OG000|Outcome|Afatinib|Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
11089374|NCT01523587|OG001|Outcome|Erlotinib|Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
11174072|NCT02019602|OG000|Outcome|PKS-M|This arm consisted of all mothers from the SS-M analysis set who provided the CZP concentration sample at delivery.
11350566|NCT04029961|BG002|Baseline|Total|Total of all reporting groups
11350567|NCT04029961|FG000|Participant Flow|Video Education|"Participants will receive video education on radiation therapy.~Video Education: Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video."
11350568|NCT04029961|FG001|Participant Flow|VR-based Education|"Participants will receive VR-based education on radiation therapy.~VR-based Education: Prior to their CT simulation, participants will receive education on radiation therapy in the form of an immersive VR program delivered through a head-mounted display (HMD)."
11350569|NCT04029961|OG000|Outcome|Video Education|"Participants will receive video education on radiation therapy.~Video Education: Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video."
11350570|NCT04029961|OG001|Outcome|VR-based Education|"Participants will receive VR-based education on radiation therapy.~VR-based Education: Prior to their CT simulation, participants will receive education on radiation therapy in the form of an immersive VR program delivered through a head-mounted display (HMD)."
11350571|NCT04029961|EG000|Reported Event|Video Education|"Participants will receive video education on radiation therapy.~Video Education: Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video."
11350572|NCT04029961|EG001|Reported Event|VR-based Education|"Participants will receive VR-based education on radiation therapy.~VR-based Education: Prior to their CT simulation, participants will receive education on radiation therapy in the form of an immersive VR program delivered through a head-mounted display (HMD)."
11350573|NCT04025684|BG000|Baseline|Oral B Indicator 123|Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350574|NCT04025684|BG001|Baseline|Dr Best Original|Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350575|NCT04025684|BG002|Baseline|Dr Best Multi Expert|Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350576|NCT04025684|BG003|Baseline|Parodontax Interdental|Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350577|NCT04025684|BG004|Baseline|Total|Total of all reporting groups
11350578|NCT04025684|FG000|Participant Flow|Oral B Indicator 123|Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 milliliters (mL) tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350579|NCT04025684|FG001|Participant Flow|Dr Best Original|Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350580|NCT04025684|FG002|Participant Flow|Dr Best Multi Expert|Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350581|NCT04025684|FG003|Participant Flow|Parodontax Interdental|Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350582|NCT04025684|OG000|Outcome|Oral B Indicator 123|Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350583|NCT04025684|OG001|Outcome|Dr Best Original|Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350584|NCT04025684|OG002|Outcome|Dr Best Multi Expert|Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350585|NCT04025684|OG003|Outcome|Parodontax Interdental|Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350586|NCT04025684|EG000|Reported Event|Oral B Indicator 123|Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350587|NCT04025684|EG001|Reported Event|Dr Best Original|Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11174073|NCT02019602|OG000|Outcome|PKS-U|This arm consisted of all umbilical cords of infants from the SS-I analysis set from which a CZP concentration sample was obtained at birth.
11350588|NCT04025684|EG002|Reported Event|Dr Best Multi Expert|Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350589|NCT04025684|EG003|Reported Event|Parodontax Interdental|Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
11350590|NCT04019054|BG000|Baseline|Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)|"Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.~Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.~Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia."
11350591|NCT04019054|BG001|Baseline|Control iTBS, Vertex|"Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.~Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.~Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia."
11350592|NCT04019054|BG002|Baseline|Total|Total of all reporting groups
11350593|NCT04019054|FG000|Participant Flow|Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)|"Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.~Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.~Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia."
11350594|NCT04019054|FG001|Participant Flow|Control iTBS, Vertex|"Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.~Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.~Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia."
11350595|NCT04019054|OG000|Outcome|Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)|"Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.~Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.~Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia."
11350596|NCT04019054|OG001|Outcome|Control iTBS, Vertex|"Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.~Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.~Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia."
11350597|NCT04019054|EG000|Reported Event|Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)|"Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.~Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.~Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia."
11350598|NCT04019054|EG001|Reported Event|Control iTBS, Vertex|"Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.~Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.~Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia."
11350599|NCT04029545|BG000|Baseline|PN40082|PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
11350600|NCT04029545|BG001|Baseline|RV001 With Lidocaine Cream|RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used with LMX4, a topical lidocaine.
11350601|NCT04029545|BG002|Baseline|RV001|RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used alone.
11350602|NCT04029545|BG003|Baseline|Total|Total of all reporting groups
11350603|NCT04029545|FG000|Participant Flow|PN40082|PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
11350604|NCT04029545|FG001|Participant Flow|RV001 With Lidocaine Cream|RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used with LMX4, a topical lidocaine.
11350605|NCT04029545|FG002|Participant Flow|RV001|RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used alone.
11350606|NCT04029545|OG000|Outcome|PN40082|PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
11350607|NCT04029545|OG001|Outcome|RV001 With Lidocaine Cream|RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used with LMX4, a topical lidocaine.
11350608|NCT04029545|OG002|Outcome|RV001|RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used alone.
11350609|NCT04029545|EG000|Reported Event|PN40082|PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
11350610|NCT04029545|EG001|Reported Event|RV001 With Lidocaine Cream|RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used with LMX4, a topical lidocaine.
11350611|NCT04029545|EG002|Reported Event|RV001|RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used alone.
11350612|NCT04029584|BG000|Baseline|All Subjects|Subjects were randomized to one of two treatment groups: 1) a single oral dose of fluvastatin (Lescol®) 20 mg capsule or 2) a single oral dose of fluvastatin (Lescol®) 20 mg capsule immediately following a 30-min intravenous infusion of rifampin 600 mg in 10 mL normal saline.
11350613|NCT04029584|FG000|Participant Flow|Fluvastatin Alone First, Then Fluvastatin +IV Rifampin 600 mg|Subjects received one oral dose of fluvastatin (Lescol®) 20mg capsule.
11350614|NCT04029584|FG001|Participant Flow|Fluvastatin +IV Rifampin 600 mg First, Then Fluvastatin Alone|Subjects received one oral dose of fluvastatin (Lescol®) 20mg capsule immediately following a 30-min intravenous infusion of rifampin 600mg in 10ml Normal Saline.
11350615|NCT04029584|OG000|Outcome|Fluvastatin Control|healthy volunteer take a single dose fluvastatin
11350616|NCT04029584|OG001|Outcome|Fluvastatin and IV Rifampin|Healthy volunteer takes a single IV rifampin prior to oral fluvastatin
11350617|NCT04029584|OG002|Outcome|Fluvastatin + Oral Rifampin Induction|Healthy volunteers who take oral rifampin for 5 days prior to oral fluvastatin
11350618|NCT04029584|OG003|Outcome|Fluvastatin +Oral Rifampin Induced +IV Rifampin|Healthy takes five days oral rifampin, and then take one oral dose of fluvastatin (Lescol®) 20mg capsule immediately following a 30-min intravenous infusion of rifampin 600mg in 10ml Normal Saline
11350619|NCT04029584|EG000|Reported Event|Uninduced Healthy Volunteer Fluvastatin Alone|Subjects randomized to receive one oral dose of fluvastatin (Lescol®) 20mg capsule
11350620|NCT04029584|EG001|Reported Event|Uninduced Healthy Volunteer Fluvastatin and Rifampin|Subjects randomized to receive one oral dose of fluvastatin 20mg immediately after a 30-min IV infusion of rifampin 600mg.
11350621|NCT04029584|EG002|Reported Event|Hepatic Induced Healthy Volunteer Fluvastatin Alone|Subjects pretreated with 5 days with 600mg oral rifampin for enzyme and transporter induction. Subjects randomized to receive one oral dose of fluvastatin 20mg
11350622|NCT04029584|EG003|Reported Event|Hepatic Induced Healthy Volunteer Fluvastatin and Rifampin|Subjects pretreated with 5 days with 600mg oral rifampin for enzyme and transporter induction. Subjects randomized to receive one oral dose of fluvastatin 20mg immediately after a 30-min IV infusion of rifampin 600mg.
11350623|NCT04029311|BG000|Baseline|Combination Therapy With Preferred Mask|"Preferred Mask refers to a type of existing medical mask used for PAP therapy.~Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP~autoPAP: autoPAP"
11350624|NCT04029311|BG001|Baseline|Combination Therapy With Custom Mask|"Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.~autoPAP: autoPAP~TAP PAP: TAP PAP"
11350625|NCT04029311|BG002|Baseline|Total|Total of all reporting groups
11350626|NCT04029311|FG000|Participant Flow|Combination Therapy With Preferred Mask|"Preferred Mask refers to a type of existing medical mask used for Positive Airway Pressure (PAP) therapy.~Nuance Pro: Study compares Nuance Pro plus Automatic Positive Airway (autoPAP ) vs TAP PAP plus autoPAP~autoPAP: autoPAP"
11350627|NCT04029311|FG001|Participant Flow|Combination Therapy With Custom Mask|"Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.~autoPAP: autoPAP~TAP PAP: TAP PAP"
11350628|NCT04029311|OG000|Outcome|Combination Therapy With Preferred Mask|"Preferred Mask refers to a type of existing medical mask used for PAP therapy.~Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP~autoPAP: autoPAP"
11350629|NCT04029311|OG001|Outcome|Combination Therapy With Custom Mask|"Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.~autoPAP: autoPAP~TAP PAP: TAP PAP"
11350630|NCT04029311|EG000|Reported Event|Combination Therapy With Preferred Mask|"Preferred Mask refers to a type of existing medical mask used for PAP therapy.~Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP~autoPAP: autoPAP"
11350631|NCT04029311|EG001|Reported Event|Combination Therapy With Custom Mask|"Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.~autoPAP: autoPAP~TAP PAP: TAP PAP"
11350632|NCT04028960|BG000|Baseline|Placebo, Then Humulin-R Insulin|"Participants first received a Placebo using the SipNose device twice daily for 14-20 days. After a washout period of 2 weeks, they received Humulin-R Insulin using the SipNose device twice daily for 14-20 days.~SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain."
11350633|NCT04028960|BG001|Baseline|Humulin-R Insulin, Then Placebo|"Participants first received Humilin-R Insulin using the SipNose device twice daily for 14-20 days. After a washout period of 2 weeks, they received a Placebo using the SipNose device twice daily for 14-20 days.~Regular insulin (Humulin-R), intranasal route: Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes.~SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain."
11350634|NCT04028960|BG002|Baseline|Total|Total of all reporting groups
11350635|NCT04028960|FG000|Participant Flow|Placebo, Then Humulin-R Insulin|"Participants first received a Placebo using the SipNose device twice daily for 14-20 days. After a washout period of 2 weeks, they received Humulin-R Insulin using the SipNose device twice daily for 14-20 days.~SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain."
11350636|NCT04028960|FG001|Participant Flow|Humulin-R Insulin, Then Placebo|"Participants first received Humulin-R Insulin using the SipNose device twice daily for 14-20 days. After a washout period of 2 weeks, they received a Placebo using the SipNose device twice daily for 14-20 days.~Regular insulin (Humulin-R), intranasal route: Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes.~SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain."
11350637|NCT04028960|OG000|Outcome|Placebo|"No active drug~SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain."
11350638|NCT04028960|OG001|Outcome|Humulin-R|"Insulin~Regular insulin (Humulin-R), intranasal route: Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes.~SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain."
11350639|NCT04028960|EG000|Reported Event|Placebo|"No active drug~SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain."
11350640|NCT04028960|EG001|Reported Event|Humulin-R|"Insulin~Regular insulin (Humulin-R), intranasal route: Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes.~SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain."
11350641|NCT04026399|BG000|Baseline|Stimulation + Therapy|"The participant receives stimulation and home therapy.~peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation.~therapy: practice of daily living tasks"
11350642|NCT04026399|BG001|Baseline|no Stimulation + Therapy|"The participant receives no stimulation and receives home therapy.~therapy: practice of daily living tasks"
11350643|NCT04026399|BG002|Baseline|Total|Total of all reporting groups
11350644|NCT04026399|FG000|Participant Flow|Stimulation + Therapy|"The participant receives stimulation and home therapy.~peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation.~therapy: practice of daily living tasks"
11350645|NCT04026399|FG001|Participant Flow|no Stimulation + Therapy|"The participant receives no stimulation and receives home therapy.~therapy: practice of daily living tasks"
11350646|NCT04026399|OG000|Outcome|Stimulation + Therapy|"The participant receives stimulation and home therapy.~peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation.~therapy: practice of daily living tasks"
11350647|NCT04026399|OG001|Outcome|no Stimulation + Therapy|"The participant receives no stimulation and receives home therapy.~therapy: practice of daily living tasks"
11350648|NCT04026399|EG000|Reported Event|Stimulation + Therapy|"The participant receives stimulation and home therapy.~peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation.~therapy: practice of daily living tasks"
11174074|NCT02019602|EG000|Reported Event|SS-M|This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery.
11350649|NCT04026399|EG001|Reported Event|no Stimulation + Therapy|"The participant receives no stimulation and receives home therapy.~therapy: practice of daily living tasks"
11350650|NCT04023578|BG000|Baseline|Rheo Knee XC|"Amputee subjects currently using either magneto-rehologic or hydraulic MPKs are fitted with the Rheo Knee XC, a magneto-rheologic MPK.~RHEO KNEE XC: Microprocessor controlled knee using Magneto-Rheologic techonology."
11350651|NCT04023578|FG000|Participant Flow|Rheo Knee XC|"Amputee subjects currently using either magneto-rehologic or hydraulic MPKs are fitted with the Rheo Knee XC, a magneto-rheologic MPK.~RHEO KNEE XC: Microprocessor controlled knee using Magneto-Rheologic techonology."
11350652|NCT04023578|OG000|Outcome|Rheo Knee XC|"Amputee subjects currently using either magneto-rehologic or hydraulic MPKs are fitted with the Rheo Knee XC, a magneto-rheologic MPK.~RHEO KNEE XC: Microprocessor controlled knee using Magneto-Rheologic techonology."
11350653|NCT04023578|OG001|Outcome|Baseline|Measurements on subjects usual prosthesis
11350654|NCT04023578|EG000|Reported Event|Rheo Knee XC|"Amputee subjects currently using either magneto-rehologic or hydraulic MPKs are fitted with the Rheo Knee XC, a magneto-rheologic MPK.~RHEO KNEE XC: Microprocessor controlled knee using Magneto-Rheologic techonology."
11350655|NCT04023695|BG000|Baseline|Corticosteroid With Lidocaine With Epinephrine|"This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine~Corticosteroid with lidocaine with epinephrine: Trigger finger injection"
11350656|NCT04023695|BG001|Baseline|Corticosteroid With Normal Saline|"This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.~Corticosteroid with normal saline: Trigger finger injection"
11350657|NCT04023695|BG002|Baseline|Total|Total of all reporting groups
11350658|NCT04023695|FG000|Participant Flow|Corticosteroid With Lidocaine With Epinephrine|"This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine~Corticosteroid with lidocaine with epinephrine: Trigger finger injection"
11350659|NCT04023695|FG001|Participant Flow|Corticosteroid With Normal Saline|"This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.~Corticosteroid with normal saline: Trigger finger injection"
11350660|NCT04023695|OG000|Outcome|Corticosteroid With Lidocaine With Epinephrine|"This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine~Corticosteroid with lidocaine with epinephrine: Trigger finger injection"
11350661|NCT04023695|OG001|Outcome|Corticosteroid With Normal Saline|"This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.~Corticosteroid with normal saline: Trigger finger injection"
11350662|NCT04023695|EG000|Reported Event|Corticosteroid With Lidocaine With Epinephrine|"This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine~Corticosteroid with lidocaine with epinephrine: Trigger finger injection"
11350663|NCT04023695|EG001|Reported Event|Corticosteroid With Normal Saline|"This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.~Corticosteroid with normal saline: Trigger finger injection"
11350664|NCT04018664|BG000|Baseline|Placebo|"Placebo~150 mL flavored beverage~Placebo solution: Placebo"
11350665|NCT04018664|BG001|Baseline|90 mg Nalbuphine HCl Solution|"90 mg nalbuphine HCl solution~9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350666|NCT04018664|BG002|Baseline|120 mg Nalbuphine HCl Solution|"120 mg nalbuphine HCl solution~12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350667|NCT04018664|BG003|Baseline|150 mg Nalbuphine HCl Solution|"150 mg nalbuphine HCl solution~15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350668|NCT04018664|BG004|Baseline|180 mg Nalbuphine HCl Solution|"180 mg nalbuphine HCl solution~18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350669|NCT04018664|BG005|Baseline|270 mg Nalbuphine HCl Solution|"270 mg nalbuphine HCl solution~27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350670|NCT04018664|BG006|Baseline|Up to 405 mg Nalbuphine HCl Solution|"Up to 405 mg nalbuphine HCl solution~Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350671|NCT04018664|BG007|Baseline|Up to 540 mg Nalbuphine HCl Solution|"Up to 540 mg nalbuphine HCl solution~Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350672|NCT04018664|BG008|Baseline|Total|Total of all reporting groups
11350673|NCT04018664|FG000|Participant Flow|Placebo|"Placebo~150 mL flavored beverage~Placebo solution: Placebo"
11350674|NCT04018664|FG001|Participant Flow|90 mg Nalbuphine HCl Solution|"90 mg nalbuphine HCl solution~9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350675|NCT04018664|FG002|Participant Flow|120 mg Nalbuphine HCl Solution|"120 mg nalbuphine HCl solution~12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350676|NCT04018664|FG003|Participant Flow|150 mg Nalbuphine HCl Solution|"150 mg nalbuphine HCl solution~15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350677|NCT04018664|FG004|Participant Flow|180 mg Nalbuphine HCl Solution|"180 mg nalbuphine HCl solution~18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350678|NCT04018664|FG005|Participant Flow|270 mg Nalbuphine HCl Solution|"270 mg nalbuphine HCl solution~27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350679|NCT04018664|FG006|Participant Flow|Up to 405 mg Nalbuphine HCl Solution|"Up to 405 mg nalbuphine HCl solution~Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350680|NCT04018664|FG007|Participant Flow|Up to 540 mg Nalbuphine HCl Solution|"Up to 540 mg nalbuphine HCl solution~Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350681|NCT04018664|OG000|Outcome|Placebo|"Placebo~150 mL flavored beverage~Placebo solution: Placebo"
11350682|NCT04018664|OG001|Outcome|90 mg Nalbuphine HCl Solution|"90 mg nalbuphine HCl solution~9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350683|NCT04018664|OG002|Outcome|120 mg Nalbuphine HCl Solution|"120 mg nalbuphine HCl solution~12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350684|NCT04018664|OG003|Outcome|150 mg Nalbuphine HCl Solution|"150 mg nalbuphine HCl solution~15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350685|NCT04018664|OG004|Outcome|180 mg Nalbuphine HCl Solution|"180 mg nalbuphine HCl solution~18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350686|NCT04018664|OG005|Outcome|270 mg Nalbuphine HCl Solution|"270 mg nalbuphine HCl solution~27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350687|NCT04018664|OG006|Outcome|Up to 405 mg Nalbuphine HCl Solution|"Up to 405 mg nalbuphine HCl solution~Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11166375|NCT01973608|BG000|Baseline|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
11174075|NCT02019602|EG001|Reported Event|SS-I|This arm consisted of all infants born to mothers in the SS-M group.
11350688|NCT04018664|OG007|Outcome|Up to 540 mg Nalbuphine HCl Solution|"Up to 540 mg nalbuphine HCl solution~Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
10887838|NCT00503113|OG001|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
11174076|NCT02019667|BG000|Baseline|All Study Participants|Participants with SSADH Deficiency who were randomized to receive either SGS-742 or Placebo
11174077|NCT02019667|FG000|Participant Flow|Placebo First, Then SGS-742|Participants were administered Placebo, followed by a washout period, and then administered SGS-742
11350689|NCT04018664|EG000|Reported Event|Placebo|"Placebo~150 mL flavored beverage~Placebo solution: Placebo"
11350690|NCT04018664|EG001|Reported Event|90 mg Nalbuphine HCl Solution|"90 mg nalbuphine HCl solution~9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350691|NCT04018664|EG002|Reported Event|120 mg Nalbuphine HCl Solution|"120 mg nalbuphine HCl solution~12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350692|NCT04018664|EG003|Reported Event|150 mg Nalbuphine HCl Solution|"150 mg nalbuphine HCl solution~15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350693|NCT04018664|EG004|Reported Event|180 mg Nalbuphine HCl Solution|"180 mg nalbuphine HCl solution~18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350694|NCT04018664|EG005|Reported Event|270 mg Nalbuphine HCl Solution|"270 mg nalbuphine HCl solution~27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
10887839|NCT00503113|OG002|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
11350695|NCT04018664|EG006|Reported Event|Up to 405 mg Nalbuphine HCl Solution|"Up to 405 mg nalbuphine HCl solution~Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350696|NCT04018664|EG007|Reported Event|Up to 540 mg Nalbuphine HCl Solution|"Up to 540 mg nalbuphine HCl solution~Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage~Nalbuphine HCl solution: nalbuphine solution administered at various strengths"
11350697|NCT04016259|BG000|Baseline|Sham-CES|Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
11350698|NCT04016259|BG001|Baseline|Self-CES|Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
11350699|NCT04016259|BG002|Baseline|Total|Total of all reporting groups
11350700|NCT04016259|FG000|Participant Flow|Sham-CES|Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
11350701|NCT04016259|FG001|Participant Flow|Self-CES|Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
11350702|NCT04016259|OG000|Outcome|Sham-CES|Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
11350703|NCT04016259|OG001|Outcome|Self-CES|Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
11350704|NCT04016259|EG000|Reported Event|Sham-CES|Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
11350705|NCT04016259|EG001|Reported Event|Self-CES|Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
11350706|NCT04016077|BG000|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
11350707|NCT04016077|BG001|Baseline|Normal Hepatic Function|Participants with normal hepatic function were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
11350708|NCT04016077|BG002|Baseline|Total|Total of all reporting groups
11350709|NCT04016077|FG000|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
11350710|NCT04016077|FG001|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
11350711|NCT04016077|OG000|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
11350712|NCT04016077|OG001|Outcome|Normal Hepatic Function|Participants with normal hepatic function were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
11350713|NCT04016077|EG000|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
11350714|NCT04016077|EG001|Reported Event|Normal Hepatic Function|Participants with normal hepatic function were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
11350715|NCT04027803|BG000|Baseline|BCD-148|"39 healthy subjects BCD-148: single 900 mg drip infusion given over 25-45 min~BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5"
11350716|NCT04027803|BG001|Baseline|Soliris|"39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min~Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5"
11350717|NCT04027803|BG002|Baseline|Total|Total of all reporting groups
11350718|NCT04027803|FG000|Participant Flow|BCD-148|"39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min~BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5"
11350719|NCT04027803|FG001|Participant Flow|Soliris|"39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min~Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5"
11350720|NCT04027803|OG000|Outcome|BCD-148|"39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min~BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5"
11350721|NCT04027803|OG001|Outcome|Soliris|"39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min~Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5"
11350722|NCT04027803|EG000|Reported Event|BCD-148|"39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min~BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5"
11350723|NCT04027803|EG001|Reported Event|Soliris|"39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min~Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5"
11229260|NCT02396537|EG001|Reported Event|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
11229261|NCT02396732|BG000|Baseline|LMWH + ASA|Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
11229262|NCT02396732|BG001|Baseline|LMWH Alone|Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
11229263|NCT02396732|BG002|Baseline|Total|Total of all reporting groups
11229264|NCT02396732|FG000|Participant Flow|LMWH + ASA|Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
11229265|NCT02396732|FG001|Participant Flow|LMWH Alone|Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
11229266|NCT02396732|OG000|Outcome|LMWH + ASA|Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
11229267|NCT02396732|OG001|Outcome|LMWH Alone|Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
11229268|NCT02396732|EG000|Reported Event|LMWH + ASA|Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
11229269|NCT02396732|EG001|Reported Event|LMWH Alone|Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
11229270|NCT02396745|BG000|Baseline|TECR & ECM|"Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM)~Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): TECR will be performed to resect the entire length and area of BE lesion.~ECM PLACEMENT:~Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA)."
11229271|NCT02396745|FG000|Participant Flow|TECR & ECM|"Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM)~Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): TECR will be performed to resect the entire length and area of BE lesion.~ECM PLACEMENT:~Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA)."
11229272|NCT02396745|OG000|Outcome|TECR & ECM|"Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM)~Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): TECR will be performed to resect the entire length and area of BE lesion.~ECM PLACEMENT:~Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA)."
11229273|NCT02396745|EG000|Reported Event|TECR & ECM|"Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM)~Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): TECR will be performed to resect the entire length and area of BE lesion.~ECM PLACEMENT:~Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA)."
11229274|NCT02396758|BG000|Baseline|APT/2 Hours-r-tPA/2 mg/hr/Catheter|"A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229275|NCT02396758|BG001|Baseline|APT/4 Hours-r-tPA/1 mg/hr/Catheter|"A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229276|NCT02396758|BG002|Baseline|APT/6 Hours-r-tPA/1 mg/hr/Catheter|"A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229277|NCT02396758|BG003|Baseline|APT/6 Hours-r-tPA/2 mg/hr/Catheter|"A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229278|NCT02396758|BG004|Baseline|Total|Total of all reporting groups
11229279|NCT02396758|FG000|Participant Flow|APT/2 Hours-r-tPA/2 mg/hr/Catheter|"A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229280|NCT02396758|FG001|Participant Flow|APT/4 Hours-r-tPA/1 mg/hr/Catheter|"A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11350724|NCT04016311|BG000|Baseline|Mindful Drinking/Eating Group|Mindful Drinking/Eating Intervention: Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.
11350725|NCT04016311|BG001|Baseline|Wait List Control|Usual treatment - offered intervention after completion of post-test data collection.
11350726|NCT04016311|BG002|Baseline|Total|Total of all reporting groups
11350727|NCT04016311|FG000|Participant Flow|Mindful Drinking/Eating Group|Mindful Drinking/Eating Intervention: Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.
11350728|NCT04016311|FG001|Participant Flow|Wait List Control|Usual treatment - offered intervention after completion of post-test data collection.
11350729|NCT04016311|OG000|Outcome|Mindful Drinking/Eating Group|Mindful Drinking/Eating Intervention: Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.
11350730|NCT04016311|OG001|Outcome|Wait List Control|Usual treatment - offered intervention after completion of post-test data collection.
11350731|NCT04016311|OG000|Outcome|Mindful Drinking/Eating Group|"Behavioral: Mindful Drinking/Eating Intervention Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.~Mindful Drinking/Eating Intervention: Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day."
11350732|NCT04016311|OG001|Outcome|Wait List Control|Usual care. Offered intervention after post-test data collected.
11350733|NCT04016311|EG000|Reported Event|Mindful Drinking/Eating Group|Mindful Drinking/Eating Intervention: Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.
11350734|NCT04016311|EG001|Reported Event|Wait List Control|Usual care. Intervention offered after post-test data collected.
11350735|NCT04027439|BG000|Baseline|0.15 mg|Single dose of RPL554 via DPI (double-blind)
11350736|NCT04027439|BG001|Baseline|0.50 mg|Single dose of RPL554 via DPI (double blind)
11174078|NCT02019667|FG001|Participant Flow|SGS-742 First, Then Placebo|Participants were administered SGS-742, followed by a washout period, and then administered Placebo
11350737|NCT04027439|BG002|Baseline|1.5 mg|Single dose of RPL554 via DPI (double blind)
11350738|NCT04027439|BG003|Baseline|3 mg|Single dose of RPL554 via DPI (double blind)
11350739|NCT04027439|BG004|Baseline|6 mg|Single dose of RPL554 via DPI (single blind)
11350740|NCT04027439|BG005|Baseline|Placebo|Single dose via DPI (double blind)
11350741|NCT04027439|BG006|Baseline|Total|Total of all reporting groups
11350742|NCT04027439|FG000|Participant Flow|0.15 mg/Part A|Part A: Single dose of RPL554 via DPI (double-blind).
11174079|NCT02019667|OG000|Outcome|Placebo|"Participants with SSADH Deficiency when on placebo for six months~Placebo"
11350743|NCT04027439|FG001|Participant Flow|0.50 mg/Part A|Part A: Single dose of RPL554 via DPI (double-blind).
11350744|NCT04027439|FG002|Participant Flow|1.5 mg/Part A|Part A: Single dose of RPL554 via DPI (double-blind).
11350745|NCT04027439|FG003|Participant Flow|3 mg/Part A|Part A: Single dose of RPL554 via DPI (double-blind).
11350746|NCT04027439|FG004|Participant Flow|6 mg/Part A|Part A: Single dose of RPL554 via DPI (single-blind). Part B: dose not used.
11350747|NCT04027439|FG005|Participant Flow|Placebo/Part A|Part A: Single dose via DPI (double-blind).
11350748|NCT04027439|FG006|Participant Flow|Seq. 1/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 1 = RPL554 .15 mg/1.5 mg/3.0 mg/.50 mg/Placebo."
11350749|NCT04027439|FG007|Participant Flow|Seq. 2/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 2 = RPL554 .15 mg/3.0 mg/Placebo/.50 mg/1.5 mg."
11350750|NCT04027439|FG008|Participant Flow|Seq. 3/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 3 = RPL554 .50 mg/3.0 mg/.15 mg/Placebo/1.5 mg."
11350751|NCT04027439|FG009|Participant Flow|Seq. 4/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 4 = RPL554 .50 mg/.15 mg/1.5 mg/Placebo/3.0 mg."
11350752|NCT04027439|FG010|Participant Flow|Seq. 5/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 5 = RPL554 1.5 mg/.50 mg/Placebo/3.0 mg/.15 mg."
11350753|NCT04027439|FG011|Participant Flow|Seq. 6/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 6 = RPL554 1.5 mg/Placebo/.15 mg/3.0 mg/.50 mg."
11229281|NCT02396758|FG002|Participant Flow|APT/6 Hours-r-tPA/1 mg/hr/Catheter|"A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229282|NCT02396758|FG003|Participant Flow|APT/6 Hours-r-tPA/2 mg/hr/Catheter|"A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229283|NCT02396758|OG000|Outcome|APT/2 Hours-r-tPA/2 mg/hr/Catheter|"A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229284|NCT02396758|OG001|Outcome|APT/4 Hours-r-tPA/1 mg/hr/Catheter|"A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229285|NCT02396758|OG002|Outcome|APT/6 Hours-r-tPA/1 mg/hr/Catheter|"A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229286|NCT02396758|OG003|Outcome|APT/6 Hours-r-tPA/2 mg/hr/Catheter|"A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229287|NCT02396758|EG000|Reported Event|APT/2 Hours-r-tPA/2 mg/hr/Catheter|"A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229288|NCT02396758|EG001|Reported Event|APT/4 Hours-r-tPA/1 mg/hr/Catheter|"A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229289|NCT02396758|EG002|Reported Event|APT/6 Hours-r-tPA/1 mg/hr/Catheter|"A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229290|NCT02396758|EG003|Reported Event|APT/6 Hours-r-tPA/2 mg/hr/Catheter|"A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.~Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS.~Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm."
11229291|NCT02396849|BG000|Baseline|CPAP|"Use of a CPAP machine for at least 5 days per week for 28 days~CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229292|NCT02396849|BG001|Baseline|CPAP Sham|"Use of a sham CPAP machine for at least 5 days per week for 28 days~CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229293|NCT02396849|BG002|Baseline|Total|Total of all reporting groups
11229294|NCT02396849|FG000|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"Use of a CPAP machine for at least 5 days per week for 28 days~CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229295|NCT02396849|FG001|Participant Flow|Continuous Positive Airway Pressure (CPAP) Sham|"Use of a sham CPAP machine for at least 5 days per week for 28 days~CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229296|NCT02396849|OG000|Outcome|CPAP|"Use of a CPAP machine for at least 5 days per week for 28 days~CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229297|NCT02396849|OG001|Outcome|CPAP Sham|"Use of a sham CPAP machine for at least 5 days per week for 28 days~CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229298|NCT02396849|OG000|Outcome|Continuous Positive Airway Pressure (CPAP)|"Use of a CPAP machine for at least 5 days per week for 28 days~CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229299|NCT02396849|OG001|Outcome|Continuous Positive Airway Pressure (CPAP) Sham|"Use of a sham CPAP machine for at least 5 days per week for 28 days~CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229300|NCT02396849|EG000|Reported Event|CPAP|"Use of a CPAP machine for at least 5 days per week for 28 days~CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11166376|NCT01973608|BG001|Baseline|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
11166377|NCT01973608|BG002|Baseline|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
11166378|NCT01973608|BG003|Baseline|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
11166379|NCT01973608|BG004|Baseline|Total|Total of all reporting groups
11166380|NCT01973608|FG000|Participant Flow|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site was targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166381|NCT01973608|FG001|Participant Flow|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166382|NCT01973608|FG002|Participant Flow|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166383|NCT01973608|FG003|Participant Flow|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166384|NCT01973608|OG000|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166385|NCT01973608|OG001|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11174080|NCT02019667|OG001|Outcome|Study Drug|"Participants with SSADH Deficiency receiving SGS-742 when on study drug for six months~SGS-742"
11229301|NCT02396849|EG001|Reported Event|CPAP Sham|"Use of a sham CPAP machine for at least 5 days per week for 28 days~CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks."
11229302|NCT02396953|BG000|Baseline|180 mg Lanreotide PRF|"On Day 1, 3 initial subjects in Cohort 1 received 180 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. The dose escalation proceeded with a 3+3+3 scheme. If 0 or 1 out of the 3 dosed subjects had experienced a DLT, 3 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have stopped, and the dose declared the maximum administered dose. If ≤3 DLTs had been observed in the 9 treated subjects and the overall safety was in line with the known lanreotide safety profile, the DRC would have allowed the dose to be escalated to 270 mg (Cohort 2).~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229303|NCT02396953|BG001|Baseline|270 mg Lanreotide PRF|"On Day 1, 1 initial subject in Cohort 2 received 270 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. Cohort 2 subjects were treated and reviewed on a 1+2+2+2+2 scheme. If no DLT was experienced, 2 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have stopped, and the dose was declared the maximum administered dose. If ≤3 DLTs had been observed in the 9 treated subjects and the overall safety was in line with the known lanreotide safety profile, the DRC would have allowed dose to be escalated to 360 mg (Cohort 3).~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229304|NCT02396953|BG002|Baseline|360 mg Lanreotide PRF|"On Day 1, 2 initial subjects in Cohort 3 received 360 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. Cohort 3 subjects were treated and reviewed on a 2+2+2+3 scheme. An additional subject was also dosed in this cohort as it was considered unethical to exclude an eligible subject. If 0 or 1 subject had experienced a DLT, 2 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have been stopped and the dose was declared the maximum administered dose.~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229305|NCT02396953|BG003|Baseline|Total|Total of all reporting groups
11229306|NCT02396953|FG000|Participant Flow|180 mg Lanreotide PRF|"On Day 1, 3 initial subjects in Cohort 1 received 180 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. The dose escalation proceeded with a 3+3+3 scheme. If 0 or 1 out of the 3 dosed subjects had experienced a dose limiting toxicity (DLT), 3 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have been stopped and the dose declared the maximum administered dose. If ≤3 DLTs had been observed in the 9 treated subjects and the overall safety was in line with the known lanreotide safety profile, the data review committee (DRC) would have allowed the dose to be escalated to 270 mg (Cohort 2).~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until end of study (EOS) at Week 25 or early withdrawal (EW)."
11229307|NCT02396953|FG001|Participant Flow|270 mg Lanreotide PRF|"On Day 1, 1 initial subject in Cohort 2 received 270 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. Cohort 2 subjects were treated and reviewed on a 1+2+2+2+2 scheme. If no DLT was experienced, 2 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have stopped, and the dose was declared the maximum administered dose. If ≤3 DLTs had been observed in the 9 treated subjects and the overall safety was in line with the known lanreotide safety profile, the DRC would have allowed dose to be escalated to 360 mg (Cohort 3).~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229308|NCT02396953|FG002|Participant Flow|360 mg Lanreotide PRF|"On Day 1, 2 initial subjects in Cohort 3 received 360 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. Cohort 3 subjects were treated and reviewed on a 2+2+2+3 scheme. An additional subject was also dosed in this cohort as it was considered unethical to exclude an eligible subject. If 0 or 1 subject had experienced a DLT, 2 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have been stopped and the dose was declared the maximum administered dose.~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229309|NCT02396953|OG000|Outcome|180 mg Lanreotide PRF|"On Day 1, 3 initial subjects in Cohort 1 received 180 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. The dose escalation proceeded with a 3+3+3 scheme. If 0 or 1 out of the 3 dosed subjects had experienced a DLT, 3 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have stopped, and the dose declared the maximum administered dose. If ≤3 DLTs had been observed in the 9 treated subjects and the overall safety was in line with the known lanreotide safety profile, the DRC would have allowed the dose to be escalated to 270 mg (Cohort 2).~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11233908|NCT02431468|EG002|Reported Event|Placebo|"Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution."
11233909|NCT02431533|BG000|Baseline|Probiotic PX0612|"PX0612 is a probiotic contained in a veggie capsule.~PX0612: PX0612 is a probiotic contained in a veggie capsule."
11233910|NCT02431533|BG001|Baseline|Di-Calcium Phosphate|"Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate~Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate"
11233911|NCT02431533|BG002|Baseline|Total|Total of all reporting groups
11166386|NCT01973608|OG002|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166387|NCT01973608|OG003|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166388|NCT01973608|OG000|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
11166389|NCT01973608|OG001|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
11166390|NCT01973608|OG002|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
11166391|NCT01973608|OG003|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
11166392|NCT01973608|EG000|Reported Event|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166393|NCT01973608|EG001|Reported Event|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166394|NCT01973608|EG002|Reported Event|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11174081|NCT02019667|EG000|Reported Event|Placebo|"Participants with SSADH Deficiency while on placebo for six months~Placebo"
11174082|NCT02019667|EG001|Reported Event|Washout Period Following Placebo|Participants with SSADH Deficiency having received Placebo, during the 9 week washout period
11350754|NCT04027439|FG012|Participant Flow|Seq. 7/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 7 = RPL554 3.0 mg/1.5 mg/.50 mg/.15 mg/Placebo."
11350755|NCT04027439|FG013|Participant Flow|Seq. 8/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 8 = RPL554 3.0 mg/Placebo/1.5 mg/.15 mg/.50 mg."
11350756|NCT04027439|FG014|Participant Flow|Seq. 9/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 9 = Placebo/.15 mg/.50 mg/1.5 mg/3.0 mg."
11350757|NCT04027439|FG015|Participant Flow|Seq. 10/Part B|"Part B: 7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over.~Seq 10 = Placebo/.50 mg/3.0 mg/1.5 mg/.15 mg."
11350758|NCT04027439|OG000|Outcome|0.15 mg|Single dose of RPL554 via DPI (double-blind)
11350759|NCT04027439|OG001|Outcome|0.50 mg|Single dose of RPL554 via DPI (double blind)
11350760|NCT04027439|OG002|Outcome|1.5 mg|Single dose of RPL554 via DPI (double blind)
11350761|NCT04027439|OG003|Outcome|3 mg|Single dose of RPL554 via DPI (double blind)
11350762|NCT04027439|OG004|Outcome|6 mg|Single dose of RPL554 via DPI (single blind)
11350763|NCT04027439|OG000|Outcome|0.15 mg|7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over
10887840|NCT00503113|EG000|Reported Event|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
11166395|NCT01973608|EG003|Reported Event|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
11166396|NCT01973777|BG000|Baseline|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
11166397|NCT01973777|FG000|Participant Flow|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
11166398|NCT01973777|OG000|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
11350764|NCT04027439|OG001|Outcome|0.50 mg|7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over
11350765|NCT04027439|OG002|Outcome|1.5 mg|7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over
11350766|NCT04027439|OG003|Outcome|3 mg|7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over
11350767|NCT04027439|OG004|Outcome|Placebo|7 day, twice daily dose of placebo via DPI (double-blind) complete block, cross-over
11350768|NCT04027439|OG005|Outcome|Placebo|Single dose via DPI (double blind)
11350769|NCT04027439|EG000|Reported Event|Part A: 0.15 mg|Single dose of RPL554 via DPI (double-blind)
11350770|NCT04027439|EG001|Reported Event|Part A: 0.50 mg|Single dose of RPL554 via DPI (double blind)
11350771|NCT04027439|EG002|Reported Event|Part A: 1.5 mg|Single dose of RPL554 via DPI (double blind)
11350772|NCT04027439|EG003|Reported Event|Part A: 3 mg|Single dose of RPL554 via DPI (double blind)
11350773|NCT04027439|EG004|Reported Event|Part A: 6 mg|Single dose of RPL554 via DPI (single blind)
11350774|NCT04027439|EG005|Reported Event|Part A: Placebo|Single dose of placebo via DPI (double blind)
10887841|NCT00503113|EG001|Reported Event|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
11350775|NCT04027439|EG006|Reported Event|Part B: 0.15 mg|7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over
11350776|NCT04027439|EG007|Reported Event|Part B: 0.50 mg|7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over
11350777|NCT04027439|EG008|Reported Event|Part B: 1.5 mg|7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over
11350778|NCT04027439|EG009|Reported Event|Part B: 3 mg|7 day, twice daily dose of RPL554 via DPI (double-blind) complete block, cross-over
11350779|NCT04027439|EG010|Reported Event|Part B: Placebo|7 day, twice daily dose of placebo via DPI (double-blind) complete block, cross-over
11350780|NCT04027218|BG000|Baseline|Current Clinical Practice First, Washout, Then Dry Heat|"First (day 1):The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.~Washout (1 week)~Second (1 day). Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power."
11350781|NCT04027218|BG001|Baseline|Current Clinical Practice First, Washout, Then High Pressure|"First (1 day): The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.~Washout (1 week) .~Second (1 day): High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse."
11350782|NCT04027218|BG002|Baseline|Current Clinical Practice First, Washout, Then Combination|"First (day 1):The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.~Washout (1 week)~Second (1 day): Combination of dry heat and high pressure: as described in dry heat application, and after 7 minutes, high pressure was applied as described for high pressure intervention."
11350783|NCT04027218|BG003|Baseline|Dry Heat First, Washout, Then Current Clinical Practice|"First (1 day). Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.~Washout (1 week)~Second (day 1):The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital."
11350784|NCT04027218|BG004|Baseline|High Pressure First, Washout, Then Current Clinical Practice|"First (1 day): High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.~Washout (1 week)~First (1 day): The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital."
11350785|NCT04027218|BG005|Baseline|Combination First, Washout, Then Current Clinical Practice|"First (1 day): Combination of dry heat and high pressure: as described in dry heat application, and after 7 minutes, high pressure was applied as described for high pressure intervention.~Washout (1 week)~Second (day 1):The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital."
11350786|NCT04027218|BG006|Baseline|Total|Total of all reporting groups
11350787|NCT04027218|FG000|Participant Flow|Current Clinical Practice First, Washout, Then Dry Heat|"First (day 1): The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.~Washout (1 week)~Second (1 day): Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power."
11350788|NCT04027218|FG001|Participant Flow|Current Clinical Practice First, Washout, Then High Pressure|"First (day 1):The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.~Washout (1 week)~Second (1 day): High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse."
11350789|NCT04027218|FG002|Participant Flow|Current Clinical Practice First, Washout, Then Combination|"First (day 1): The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.~Washout (1 week)~Second (1 day): Combination of dry heat and high pressure: as described in dry heat application, and after 7 minutes, high pressure was applied as described for high pressure intervention."
11350790|NCT04027218|FG003|Participant Flow|Dry Heat First, Washout, Then Current Clinical Practice|"First ( day 1): Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.~Washout (1 week)~Second (day 1): The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital."
11350791|NCT04027218|FG004|Participant Flow|High Pressure First, Washout, Then Current Clinical Practice|"First (day 1): High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.~Washout (1 week)~Second (8 day 1):The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital."
11350792|NCT04027218|FG005|Participant Flow|Combination First, Washout, Then Current Clinical Practice|"First (day 1): Combination of dry heat and high pressure: as described in dry heat application, and after 7 minutes, high pressure was applied as described for high pressure intervention.~Washout (1 week)~Second (day 1): The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital."
10887842|NCT00503113|EG002|Reported Event|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
11166399|NCT01973777|EG000|Reported Event|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
10887843|NCT00503139|BG000|Baseline|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
10887844|NCT00503139|FG000|Participant Flow|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
10887845|NCT00503139|OG000|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
11350793|NCT04027218|OG000|Outcome|Dry Heat|Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
11350794|NCT04027218|OG001|Outcome|High Pressure|High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
11350795|NCT04027218|OG002|Outcome|Combination|Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
11350796|NCT04027218|OG003|Outcome|Current Clinical Practice|The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
11350797|NCT04027218|EG000|Reported Event|Dry Heat|Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
11350798|NCT04027218|EG001|Reported Event|High Pressure|High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
11350799|NCT04027218|EG002|Reported Event|Combination|Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
11350800|NCT04027218|EG003|Reported Event|Current Clinical Practice|The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
11350801|NCT04026750|BG000|Baseline|Pitolisant 36mg|2-18 mg tablets per day for 7 days
11350802|NCT04026750|BG001|Baseline|Placebo|2-Placebo to match 18mg of pitolisant
11350803|NCT04026750|BG002|Baseline|Total|Total of all reporting groups
11350804|NCT04026750|FG000|Participant Flow|Pitolisant 36mg|2-18mg tablets once daily for 7 days
11350805|NCT04026750|FG001|Participant Flow|Placebo|2- Placebo tablets to match pitolisant 18mg once daily for 7 days
11174083|NCT02019667|EG002|Reported Event|Study Drug|"Participants with SSADH Deficiency receiving SGS-742 while on study drug for six months~SGS-742"
11350806|NCT04026750|OG000|Outcome|Pitolisant 36mg|2-18mg tablets once daily for 7 days
11350807|NCT04026750|OG001|Outcome|Placebo|2- Placebo to match pitolisant 18mg once daily for 7 days
11350808|NCT04026750|OG001|Outcome|Placebo|2- Placebo to match pitolisant once daily for 7 days
11350809|NCT04026750|EG000|Reported Event|Pitolisant 36mg|2-18 mg tablets per day for 7 days
11350810|NCT04026750|EG001|Reported Event|Placebo|2-Placebo to match 18mg of pitolisant
11350811|NCT04026308|BG000|Baseline|Written Safety Plan|Participants will complete a traditional written suicide safety plan.
11350812|NCT04026308|BG001|Baseline|Electronic Safety Plan|"Participants will complete a suicide safety plan in the Safety Net app using a tablet.~Safety Net App: The Safety Net app is an electronic version of a safety plan and it is available for download in Apple's App Store. A preview of the app is available at: https://apps.apple.com/us/app/stanley-brown-safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was developed in partnership with the New York State Office of Mental Health. Unlike the paper version, the Safety Net app allows participants to email a copy of their safety plan to whomever they wish. It also allows patients to dial 911 or the National Suicide Prevention Lifeline from the app."
11174084|NCT02019667|EG003|Reported Event|Washout Period Following Study Drug|Participants with SSADH Deficiency having received SGS-742, during the 9 week washout period
11350813|NCT04026308|BG002|Baseline|Total|Total of all reporting groups
11350814|NCT04026308|FG000|Participant Flow|Written Safety Plan|Participants will complete a traditional written suicide safety plan.
11350815|NCT04026308|FG001|Participant Flow|Electronic Safety Plan|"Participants will complete a suicide safety plan in the Safety Net app using a tablet.~Safety Net App: The Safety Net app is an electronic version of a safety plan and it is available for download in Apple's App Store. A preview of the app is available at: https://apps.apple.com/us/app/stanley-brown-safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was developed in partnership with the New York State Office of Mental Health. Unlike the paper version, the Safety Net app allows participants to email a copy of their safety plan to whomever they wish. It also allows patients to dial 911 or the National Suicide Prevention Lifeline from the app."
11350816|NCT04026308|OG000|Outcome|Written Safety Plan|Participants will complete a traditional written suicide safety plan.
11350817|NCT04026308|OG001|Outcome|Electronic Safety Plan|"Participants will complete a suicide safety plan in the Safety Net app using a tablet.~Safety Net App: The Safety Net app is an electronic version of a safety plan and it is available for download in Apple's App Store. A preview of the app is available at: https://apps.apple.com/us/app/stanley-brown-safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was developed in partnership with the New York State Office of Mental Health. Unlike the paper version, the Safety Net app allows participants to email a copy of their safety plan to whomever they wish. It also allows patients to dial 911 or the National Suicide Prevention Lifeline from the app."
11350818|NCT04026308|EG000|Reported Event|Written Safety Plan|Participants will complete a traditional written suicide safety plan.
11350819|NCT04026308|EG001|Reported Event|Electronic Safety Plan|"Participants will complete a suicide safety plan in the Safety Net app using a tablet.~Safety Net App: The Safety Net app is an electronic version of a safety plan and it is available for download in Apple's App Store. A preview of the app is available at: https://apps.apple.com/us/app/stanley-brown-safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was developed in partnership with the New York State Office of Mental Health. Unlike the paper version, the Safety Net app allows participants to email a copy of their safety plan to whomever they wish. It also allows patients to dial 911 or the National Suicide Prevention Lifeline from the app."
11350820|NCT04023682|BG000|Baseline|Anesthesia Provider Hands|"Anesthesia Providers hands cultures with standard hand hygiene~Provodine Hand Sanitizer: Intervention with Provodine"
11350821|NCT04023682|FG000|Participant Flow|Anesthesia Provider Hands|"Anesthesia Providers hands cultures with standard hand hygiene~Provodine Hand Sanitizer: Intervention with Provodine"
11350822|NCT04023682|OG000|Outcome|Anesthesia Provider Hands|Anesthesia Providers hands cultures with standard hand hygiene
11350823|NCT04023682|OG000|Outcome|Anesthesia Provider Hands|"Anesthesia Providers hands cultures after use with Provodine hand sanitizer.~Provodine Hand Sanitizer: Intervention with Provodine"
11350824|NCT04023682|OG000|Outcome|Anesthesia Provider Hands|"Anesthesia Providers hands cultures with standard hand hygiene~Provodine Hand Sanitizer: Intervention with Provodine"
11350825|NCT04023682|OG000|Outcome|Anesthesia Provider Hands|Anesthesia Providers hands cultures after use with Provodine hand sanitizer.
11350826|NCT04023682|OG000|Outcome|Anesthesia Provider Hands|Anesthesia Providers hands cultures
11350827|NCT04023682|EG000|Reported Event|Anesthesia Provider Hands|"Anesthesia Providers hands cultures with standard hand hygiene~Provodine Hand Sanitizer: Intervention with Provodine"
11350828|NCT04021771|BG000|Baseline|Group A (Intervention Group)|"Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. Participants in Group A were given access to the intervention. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP. Group A returned for a third visit (T3) to provide information about the decay of learned skills and if performance on the task is maintained by a single intervention.~Educational Curriculum Intervention: The intervention included: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment."
11350829|NCT04021771|BG001|Baseline|Group B (Control Group)|"Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP; following this session, participants in Group B were introduced to the intervention. The Group B returned for a third visit (T3) to provide information on how the curriculum impacts their score.~Educational Curriculum Intervention: The intervention included: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment."
11350830|NCT04021771|BG002|Baseline|Total|Total of all reporting groups
11350831|NCT04021771|FG000|Participant Flow|Group A (Intervention Group)|"Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. Participants in Group A were given access to the intervention. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP. Group A returned for a third visit (T3) to provide information about the decay of learned skills and if performance on the task is maintained by a single intervention.~Educational Curriculum Intervention: The intervention included: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment."
11357191|NCT03763058|OG000|Outcome|Music Intervention|"The music intervention is administered via a smartphone- (and computer-) based application called Music Care.~Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the U technique designed to gradually relax the listener. The U technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.~Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month."
11350832|NCT04021771|FG001|Participant Flow|Group B (Control Group)|"Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP; following this session, participants in Group B were introduced to the intervention. The Group B returned for a third visit (T3) to provide information on how the curriculum impacts their score.~Educational Curriculum Intervention: The intervention included: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment."
11350833|NCT04021771|OG000|Outcome|Group A (Intervention Group)|"Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. Participants in Group A were given access to the intervention. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP. Group A returned for a third visit (T3) to provide information about the decay of learned skills and if performance on the task is maintained by a single intervention.~Educational Curriculum Intervention: The intervention included: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment."
11350834|NCT04021771|OG001|Outcome|Group B (Control Group)|"Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP; following this session, participants in Group B were introduced to the intervention. The Group B returned for a third visit (T3) to provide information on how the curriculum impacts their score.~Educational Curriculum Intervention: The intervention included: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment."
11350835|NCT04021771|EG000|Reported Event|Group A (Intervention Group)|"Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. Participants in Group A were given access to the intervention. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP. Group A returned for a third visit (T3) to provide information about the decay of learned skills and if performance on the task is maintained by a single intervention.~Educational Curriculum Intervention: The intervention included: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment."
11350836|NCT04021771|EG001|Reported Event|Group B (Control Group)|"Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP; following this session, participants in Group B were introduced to the intervention. The Group B returned for a third visit (T3) to provide information on how the curriculum impacts their score.~Educational Curriculum Intervention: The intervention included: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment."
11350837|NCT04019626|BG000|Baseline|Myblu Tobacco Flavor 2.5%|Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
11350838|NCT04019626|BG001|Baseline|Myblu Tobacco Flavor 4.0%|Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
11350839|NCT04019626|BG002|Baseline|Myblu Honeymoon 2.5%|Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
11350840|NCT04019626|BG003|Baseline|Myblu Honeymoon 4.0%|Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
11174085|NCT02019719|BG000|Baseline|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
11174086|NCT02019719|BG001|Baseline|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
11174087|NCT02019719|BG002|Baseline|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
11174088|NCT02019719|BG003|Baseline|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
11174089|NCT02019719|BG004|Baseline|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
11174090|NCT02019719|BG005|Baseline|Total|Total of all reporting groups
11174091|NCT02019719|FG000|Participant Flow|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
11174092|NCT02019719|FG001|Participant Flow|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 milligrams (mg) once daily for the 4 Week treatment period.
11174093|NCT02019719|FG002|Participant Flow|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
11174094|NCT02019719|FG003|Participant Flow|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
11174095|NCT02019719|FG004|Participant Flow|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
11174096|NCT02019719|OG000|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4W treatment period.
11174097|NCT02019719|OG001|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 weeks treatment period.
11174098|NCT02019719|OG002|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 weeks treatment period.
11174099|NCT02019719|OG003|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 weeks treatment period.
11174100|NCT02019719|OG004|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 weeks treatment period.
11174101|NCT02019719|OG000|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
11174102|NCT02019719|OG001|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
11174103|NCT02019719|OG002|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
11174104|NCT02019719|OG003|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
11174105|NCT02019719|OG004|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
11174106|NCT02019719|OG004|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period
11174107|NCT02019719|OG001|Outcome|GSK1278863 4 Milligrams (mg)|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
11174108|NCT02019719|EG000|Reported Event|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4W treatment period.
11174109|NCT02019719|EG001|Reported Event|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4W treatment period.
11174110|NCT02019719|EG002|Reported Event|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4W treatment period.
11174111|NCT02019719|EG003|Reported Event|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4W treatment period.
11174112|NCT02019719|EG004|Reported Event|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4W treatment period.
11174113|NCT02019758|BG000|Baseline|Oral Viscous Budesonide (OVB)|"Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.~Oral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily~Placebo inhaler: Placebo inhaler - 4 puffs twice daily"
11174114|NCT02019758|BG001|Baseline|Active Fluticasone MDI|"Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.~Fluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)~Placebo slurry: Slurry of sucralose - 4 mL twice daily"
11174115|NCT02019758|BG002|Baseline|Total|Total of all reporting groups
11174116|NCT02019758|FG000|Participant Flow|Oral Viscous Budesonide (OVB)|"Subjects will be treated with Oral Viscous Budesonide (OVB) at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.~Oral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily~Placebo inhaler: Placebo inhaler - 4 puffs twice daily"
11174117|NCT02019758|FG001|Participant Flow|Active Fluticasone Metered Dose Inhaler (MDI)|"Subjects will be treated with fluticasone Metered Dose Inhaler (MDI) at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.~Fluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)~Placebo slurry: Slurry of sucralose - 4 mL twice daily"
11174118|NCT02019758|OG000|Outcome|Oral Viscous Budesonide (OVB)|"Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.~Oral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily~Placebo inhaler: Placebo inhaler - 4 puffs twice daily"
11174119|NCT02019758|OG001|Outcome|Active Fluticasone MDI|"Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.~Fluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)~Placebo slurry: Slurry of sucralose - 4 mL twice daily"
11350841|NCT04019626|BG004|Baseline|Continue-smoking|"The subject's usual brand of combustible cigarette~Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette"
11350842|NCT04019626|BG005|Baseline|Total|Total of all reporting groups
11350843|NCT04019626|FG000|Participant Flow|Myblu Tobacco Flavor 2.5%|Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
11350844|NCT04019626|FG001|Participant Flow|Myblu Tobacco Flavor 4.0%|Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
11350845|NCT04019626|FG002|Participant Flow|Myblu Honeymoon 2.5%|Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
11350846|NCT04019626|FG003|Participant Flow|Myblu Honeymoon 4.0%|Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
11350847|NCT04019626|FG004|Participant Flow|Continue-smoking|"The subject's usual brand of combustible cigarette~Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette"
11350848|NCT04019626|FG005|Participant Flow|JUUL 5%|Use of JUUL 5% nicotine e-cigarette
11350849|NCT04019626|OG000|Outcome|Myblu Tobacco Flavor 2.5%|Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
11350850|NCT04019626|OG001|Outcome|Myblu Tobacco Flavor 4.0%|Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
11350851|NCT04019626|OG002|Outcome|Myblu Honeymoon 2.5%|Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
11350852|NCT04019626|OG003|Outcome|Myblu Honeymoon 4.0%|Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
11350853|NCT04019626|OG004|Outcome|Continue-smoking|"The subject's usual brand of combustible cigarette~Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette"
11350854|NCT04019626|OG005|Outcome|JUUL® 5.0%|Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
11350855|NCT04019626|EG000|Reported Event|Myblu Tobacco Flavor 2.5%|Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
11350856|NCT04019626|EG001|Reported Event|Myblu Tobacco Flavor 4.0%|Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
11350857|NCT04019626|EG002|Reported Event|Myblu Honeymoon 2.5%|Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
11350858|NCT04019626|EG003|Reported Event|Myblu Honeymoon 4.0%|Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
11350859|NCT04019626|EG004|Reported Event|Continue-smoking|"The subject's usual brand of combustible cigarette~Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette"
11350860|NCT04019626|EG005|Reported Event|JUUL® 5.0%|Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
11350861|NCT04023994|BG000|Baseline|Placebo|In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort.
11350862|NCT04023994|BG001|Baseline|RO7126209 (0.1 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/kg).
11350863|NCT04023994|BG002|Baseline|RO7126209 (0.4 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg).
11350864|NCT04023994|BG003|Baseline|RO7126209 (1.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
11350865|NCT04023994|BG004|Baseline|RO7126209 (3.6 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg).
11350866|NCT04023994|BG005|Baseline|RO7126209 (7.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg).
11350867|NCT04023994|BG006|Baseline|Total|Total of all reporting groups
11350868|NCT04023994|FG000|Participant Flow|Placebo|In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort.
11350869|NCT04023994|FG001|Participant Flow|RO7126209 (0.1 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/kg).
11350870|NCT04023994|FG002|Participant Flow|RO7126209 (0.4 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg).
11350871|NCT04023994|FG003|Participant Flow|RO7126209 (1.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
11350872|NCT04023994|FG004|Participant Flow|RO7126209 (3.6 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg).
11350873|NCT04023994|FG005|Participant Flow|RO7126209 (7.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg).
11350874|NCT04023994|OG000|Outcome|Placebo|In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort.
11350875|NCT04023994|OG001|Outcome|RO7126209 (0.1 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/kg).
11350876|NCT04023994|OG002|Outcome|RO7126209 (0.4 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg).
11350877|NCT04023994|OG003|Outcome|RO7126209 (1.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
11350878|NCT04023994|OG004|Outcome|RO7126209 (3.6 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg).
11350879|NCT04023994|OG005|Outcome|RO7126209 (7.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg).
11350880|NCT04023994|OG000|Outcome|RO7126209 (0.1 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/kg).
11350881|NCT04023994|OG001|Outcome|RO7126209 (0.4 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg).
11350882|NCT04023994|OG002|Outcome|RO7126209 (1.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
11350883|NCT04023994|OG003|Outcome|RO7126209 (3.6 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg).
11350884|NCT04023994|OG004|Outcome|RO7126209 (7.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg).
11350885|NCT04023994|EG000|Reported Event|Placebo|In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort.
11350886|NCT04023994|EG001|Reported Event|RO7126209 (0.1 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/kg).
11350887|NCT04023994|EG002|Reported Event|RO7126209 (0.4 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg).
11350888|NCT04023994|EG003|Reported Event|RO7126209 (1.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
10887846|NCT00503139|EG000|Reported Event|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
11166400|NCT01973972|BG000|Baseline|Weight Management/Shared Medical Appointment (WM/SMA)|"Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.~Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.~Shared medical appointments (SMA): Diabetes management group visits for diabetes management."
11166401|NCT01973972|BG001|Baseline|Shared Medical Appointments (SMA)|"Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.~Shared medical appointments (SMA): Diabetes management group visits for diabetes management."
11166402|NCT01973972|BG002|Baseline|Total|Total of all reporting groups
11166403|NCT01973972|FG000|Participant Flow|Weight Management/Shared Medical Appointment (WM/SMA)|"Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.~Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.~Shared medical appointments (SMA): Diabetes management group visits for diabetes management."
11166404|NCT01973972|FG001|Participant Flow|Shared Medical Appointments (SMA)|"Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.~Shared medical appointments (SMA): Diabetes management group visits for diabetes management."
11166405|NCT01973972|OG000|Outcome|Weight Management/Shared Medical Appointment (WM/SMA)|"Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.~Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.~Shared medical appointments (SMA): Diabetes management group visits for diabetes management."
11350889|NCT04023994|EG004|Reported Event|RO7126209 (3.6 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg).
11350890|NCT04023994|EG005|Reported Event|RO7126209 (7.2 mg/kg)|Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg).
11350891|NCT04022668|BG000|Baseline|STEMI|"Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.~Coronary angiogram: Routine coronary angiogram, if indicated"
11350892|NCT04022668|BG001|Baseline|NSTEMI|"Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.~Coronary angiogram: Routine coronary angiogram, if indicated"
11350893|NCT04022668|BG002|Baseline|Normal|Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
11350894|NCT04022668|BG003|Baseline|Total|Total of all reporting groups
11350895|NCT04022668|FG000|Participant Flow|STEMI|"Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.~Coronary angiogram: Routine coronary angiogram, if indicated"
11350896|NCT04022668|FG001|Participant Flow|NSTEMI|"Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.~Coronary angiogram: Routine coronary angiogram, if indicated"
11350897|NCT04022668|FG002|Participant Flow|Normal|Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
11350898|NCT04022668|OG000|Outcome|STEMI|"Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.~Coronary angiogram: Routine coronary angiogram, if indicated"
11350899|NCT04022668|OG001|Outcome|NSTEMI|"Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.~Coronary angiogram: Routine coronary angiogram, if indicated"
11350900|NCT04022668|OG002|Outcome|Normal|Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
11350901|NCT04022668|EG000|Reported Event|STEMI|"Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.~Coronary angiogram: Routine coronary angiogram, if indicated"
11350902|NCT04022668|EG001|Reported Event|NSTEMI|"Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.~Coronary angiogram: Routine coronary angiogram, if indicated"
11350903|NCT04022668|EG002|Reported Event|Normal|Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
11350904|NCT04020822|BG000|Baseline|Subjects Wearing Guardian Sensor (3)s|"Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.~Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter."
11350905|NCT04020822|FG000|Participant Flow|Subjects Wearing Guardian Sensor (3)s|"Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.~Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter."
11350906|NCT04020822|OG000|Outcome|Subjects Wearing Guardian Sensor (3)s|"Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.~Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter."
10887847|NCT00503308|BG000|Baseline|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2-5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
11350907|NCT04020822|EG000|Reported Event|Subjects Wearing Guardian Sensor (3)s|"Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.~Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter."
11350908|NCT04019990|BG000|Baseline|Wheelchair Basketball and Ambulant Basketball Players|"13 players from the North Cyprus wheelchair Basketball Team and 15 players from the Koop Bank Basketball Men's Team voluntarily will participate in the study. Subjects will include to study if they fulfil criteria. Athletes will involve in 8 weeks Thrower's Ten exercise program. After 8. Weeks and 12. Weeks assessments will be repeated.~The effect of throwers ten exercise programme on wheelchair basketball and ambulant basketball players: Throwers Ten exercise programme is a programme designed to improve the power, strength and endurance of large muscle groups required for the throwing activity. It consists of exercises involving the movement of upper limb joints in full range of joint motion or at specified specific angles, with the help of a resistance band and weights specific to individual athletes. In the literature, no study has demonstrated the effectiveness of Throwers Ten exercise programme in wheelchair basketball and ambulant basketball players."
10887848|NCT00503308|BG001|Baseline|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
11229310|NCT02396953|OG001|Outcome|270 mg Lanreotide PRF|"On Day 1, 1 initial subject in Cohort 2 received 270 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. Cohort 2 subjects were treated and reviewed on a 1+2+2+2+2 scheme. If no DLT was experienced, 2 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have stopped, and the dose was declared the maximum administered dose. If ≤3 DLTs had been observed in the 9 treated subjects and the overall safety was in line with the known lanreotide safety profile, the DRC would have allowed dose to be escalated to 360 mg (Cohort 3).~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229311|NCT02396953|OG002|Outcome|360 mg Lanreotide PRF|"On Day 1, 2 initial subjects in Cohort 3 received 360 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. Cohort 3 subjects were treated and reviewed on a 2+2+2+3 scheme. An additional subject was also dosed in this cohort as it was considered unethical to exclude an eligible subject. If 0 or 1 subject had experienced a DLT, 2 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have been stopped and the dose was declared the maximum administered dose.~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229312|NCT02396953|OG000|Outcome|Lanreotide PK Set: 180 mg Lanreotide PRF|The lanreotide PK dataset included the 9 subjects from the PK valid population who were not pre-treated with lanreotide and who received 1 deep subcutaneous injection of 180 mg lanreotide PRF.
11229313|NCT02396953|OG001|Outcome|Lanreotide PK Set: 270 mg Lanreotide PRF|The lanreotide PK dataset included the 7 subjects from the PK valid population who were not pre-treated with lanreotide and who received 1 deep subcutaneous injection of 270 mg lanreotide PRF. The 2 subjects previously treated with a stable dose of lanreotide Autogel were expected to have a detectable pre-dose concentration and it was considered relevant to exclude them.
11229314|NCT02396953|OG002|Outcome|Lanreotide PK Set: 360 mg Lanreotide PRF|The lanreotide PK dataset included 6 subjects from the PK valid population who were not pre-treated with lanreotide and who received 1 deep subcutaneous injection of 360 mg lanreotide PRF. The 3 subjects previously treated with a stable dose of lanreotide Autogel were expected to have a detectable pre-dose concentration and it was considered relevant to exclude them.
11229315|NCT02396953|OG002|Outcome|Lanreotide PK Set: 360 mg Lanreotide PRF|The lanreotide PK dataset included the 6 subjects from the PK valid population who were not pre-treated with lanreotide and who received 1 deep subcutaneous injection of 360 mg lanreotide PRF. The 3 subjects previously treated with a stable dose of lanreotide Autogel were expected to have a detectable pre-dose concentration and it was considered relevant to exclude them.
11229316|NCT02396953|OG000|Outcome|Glycofurol PK Set: 180 mg Lanreotide PRF|This glycofurol dataset included 9 subjects from the PK valid population who had a sufficient number of serum glycofurol concentrations to estimate the main glycofurol PK parameters (Cmax, Tmax, and AUC) and who received 1 deep subcutaneous injection of 180 mg lanreotide PRF.
11229317|NCT02396953|OG001|Outcome|Glycofurol PK Set: 270 mg Lanreotide PRF|This glycofurol dataset included 9 subjects from the PK valid population who had a sufficient number of serum glycofurol concentrations to estimate the main glycofurol PK parameters (Cmax, Tmax, and AUC) and who received 1 deep subcutaneous injection of 270 mg lanreotide PRF.
11229318|NCT02396953|OG002|Outcome|Glycofurol PK Set: 360 mg Lanreotide PRF|Due to bioanalytical issues, no results for the excipient N1-glycofurol and N2-glycofurol for this cohort were available at the time of the PK analysis.
11229319|NCT02396953|EG000|Reported Event|180 mg Lanreotide PRF|"On Day 1, 3 initial subjects in Cohort 1 received 180 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. The dose escalation proceeded with a 3+3+3 scheme. If 0 or 1 out of the 3 dosed subjects had experienced a DLT, 3 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have stopped, and the dose declared the maximum administered dose. If ≤3 DLTs had been observed in the 9 treated subjects and the overall safety was in line with the known lanreotide safety profile, the DRC would have allowed the dose to be escalated to 270 mg (Cohort 2).~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229320|NCT02396953|EG001|Reported Event|270 mg Lanreotide PRF|"On Day 1, 1 initial subject in Cohort 2 received 270 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. Cohort 2 subjects were treated and reviewed on a 1+2+2+2+2 scheme. If no DLT was experienced, 2 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have stopped, and the dose was declared the maximum administered dose. If ≤3 DLTs had been observed in the 9 treated subjects and the overall safety was in line with the known lanreotide safety profile, the DRC would have allowed dose to be escalated to 360 mg (Cohort 3).~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229321|NCT02396953|EG002|Reported Event|360 mg Lanreotide PRF|"On Day 1, 2 initial subjects in Cohort 3 received 360 mg lanreotide PRF by a single deep subcutaneous injection in the superior, external quadrant of the buttock and a 12-week treatment period then commenced. Cohort 3 subjects were treated and reviewed on a 2+2+2+3 scheme. An additional subject was also dosed in this cohort as it was considered unethical to exclude an eligible subject. If 0 or 1 subject had experienced a DLT, 2 more subjects would have been dosed with the same dose. If more than 3 out of 9 subjects had experienced a DLT, dose escalation would have been stopped and the dose was declared the maximum administered dose.~At the end of the treatment period subjects continued to be assessed over a 12-week follow up period until EOS at Week 25 or EW."
11229322|NCT02397057|BG000|Baseline|Injectafer|"Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.~Injectafer"
11229323|NCT02397057|BG001|Baseline|Normal Saline|"IV Placebo (15ml of Normal Saline) IV push at 2ml/minute~Placebo"
11229324|NCT02397057|BG002|Baseline|Total|Total of all reporting groups
11229325|NCT02397057|FG000|Participant Flow|Injectafer|"Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.~Injectafer"
11350909|NCT04019990|FG000|Participant Flow|Wheelchair Basketball Players|13 players from the North Cyprus Turkcell Wheelchair Basketball Team voluntarily participated in the study. During evaluations and training, one WC basketball player was excluded from the study as they failed to meet the inclusion criteria. After preliminary evaluation, all participants took part in the Throwers Ten exercise programme 3 days a week for 8 weeks. Evaluations were made before the exercise programme, at week 8 at programme completion, and at week 12 after programme completion.
11350910|NCT04019990|FG001|Participant Flow|Ambulant Basketball Players|15 players from the Koop Bank Basketball Men's Team voluntarily participated in the study. During evaluations and training three basketball players were excluded from the study as they failed to meet the inclusion criteria. After preliminary evaluation, all participants took part in the Throwers Ten exercise programme 3 days a week for 8 weeks. Evaluations were made before the exercise programme, at week 8 at programme completion, and at week 12 after programme completion.
11350911|NCT04019990|OG000|Outcome|Wheelchair Basketball and Ambulant Basketball Players|13 players from the North Cyprus Turkcell Wheelchair Basketball Team and 15 players from the Koop Bank Basketball Men's Team voluntarily participated in the study. During evaluations and training, 1 wheelchair basketball player, and 3 stand-up basketball players were excluded from the study as they failed to meet the inclusion criteria. The final participants were 12 male wheelchair basketball players and12 male stand-up basketball players. After preliminary evaluation, all participants took part in the Throwers Ten exercise programme 3 days a week for 8 weeks. Evaluations were made before the exercise programme, at week 8 at programme completion, and at week 12 after programme completion.
11350912|NCT04019990|OG000|Outcome|Wheelchair Basketball and Ambulant Basketball Players|13 players from the North Cyprus Turkcell Wheelchair Basketball Team and 15 players from the Koop Bank Basketball Men's Team voluntarily participated in the study. During evaluations and training, one WC basketball player, and three stand-up basketball players were excluded from the study as they failed to meet the inclusion criteria. The final participants were 12 male wheelchair basketball players and 12 male stand-up basketball players. After preliminary evaluation, all participants took part in the Throwers Ten exercise programme 3 days a week for 8 weeks. Evaluations were made before the exercise programme, at week 8 at programme completion, and at week 12 after programme completion.
11350913|NCT04019990|OG000|Outcome|Wheelchair Basketball and Ambulant Basketball Players|13 players from the North Cyprus Turkcell Wheelchair Basketball Team and 15 players from the Koop Bank Basketball Men's Team voluntarily participated in the study. During evaluations and training, 1 wheelchair basketball player, and 3 stand-up basketball players were excluded from the study as they failed to meet the inclusion criteria. The final participants were 12 male wheelchair basketball players and 12 male stand-up basketball players. After preliminary evaluation, all participants took part in the Throwers Ten exercise programme 3 days a week for 8 weeks. Evaluations were made before the exercise programme, at week 8 at programme completion, and at week 12 after programme completion.
11350914|NCT04019990|EG000|Reported Event|Wheelchair Basketball and Ambulant Basketball Players|13 players from the North Cyprus Turkcell WC Basketball Team and 15 players from the Koop Bank Basketball Men's Team voluntarily participated in the study. During evaluations and training, one WC basketball player, and three stand-up basketball players were excluded from the study as they failed to meet the inclusion criteria. The final participants were 12 male WC basketball players and 12 male stand-up basketball players. After preliminary evaluation, all participants took part in the Throwers Ten exercise programme 3 days a week for 8 weeks. Evaluations were made before the exercise programme, at week 8 in programme completion, and at week 12 after programme completion.
11350915|NCT04017611|BG000|Baseline|INVSENSOR00038|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor.~INVSENSOR00038: Noninvasive regional oximeter"
11350916|NCT04017611|FG000|Participant Flow|INVSENSOR00038|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor.~INVSENSOR00038: Noninvasive regional oximeter"
11350917|NCT04017611|OG000|Outcome|INVSENSOR00038|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor.~INVSENSOR00038: Noninvasive regional oximeter"
11350918|NCT04017611|EG000|Reported Event|INVSENSOR00038|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor.~INVSENSOR00038: Noninvasive regional oximeter"
11350919|NCT04015232|BG000|Baseline|INTP5 Biosimilar Product|"INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~INTP5: A pegfilgrastim biosimilar to US Neulasta."
11166406|NCT01973972|OG001|Outcome|Shared Medical Appointments (SMA)|"Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.~Shared medical appointments (SMA): Diabetes management group visits for diabetes management."
11174120|NCT02019758|EG000|Reported Event|Oral Viscous Budesonide (OVB)|"Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.~Oral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily~Placebo inhaler: Placebo inhaler - 4 puffs twice daily"
11350920|NCT04015232|BG001|Baseline|US Neulasta Reference Product|"US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~US Neulasta: FDA approved pegfilgrastim innovator product."
11350921|NCT04015232|BG002|Baseline|Total|Total of all reporting groups
11350922|NCT04015232|FG000|Participant Flow|INTP5 Biosimilar Product|"INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~INTP5: A pegfilgrastim biosimilar to US Neulasta."
11350923|NCT04015232|FG001|Participant Flow|US Neulasta Reference Product|"US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~US Neulasta: FDA approved pegfilgrastim innovator product."
11350924|NCT04015232|OG000|Outcome|INTP5 Biosimilar Product|"INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~INTP5: A pegfilgrastim biosimilar to US Neulasta."
11350925|NCT04015232|OG001|Outcome|US Neulasta Reference Product|"US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~US Neulasta: FDA approved pegfilgrastim innovator product."
11350926|NCT04015232|OG000|Outcome|INTP5 Dose 1|"INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~INTP5: A pegfilgrastim biosimilar to US Neulasta."
11350927|NCT04015232|OG001|Outcome|INTP5 Dose 2|"INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~INTP5: A pegfilgrastim biosimilar to US Neulasta"
11166407|NCT01973972|EG000|Reported Event|Weight Management/Shared Medical Appointment (WM/SMA)|"Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.~Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.~Shared medical appointments (SMA): Diabetes management group visits for diabetes management."
11166408|NCT01973972|EG001|Reported Event|Shared Medical Appointments (SMA)|"Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.~Shared medical appointments (SMA): Diabetes management group visits for diabetes management."
11166409|NCT01973998|BG000|Baseline|Roflumilast|"500 ug tablet daily for 180 days~Roflumilast: PDE4 inhibitor"
11166410|NCT01973998|BG001|Baseline|Placebo|"Placebo 1 tablet daily x 180 days~Placebo: Inactive substance."
11166411|NCT01973998|BG002|Baseline|Total|Total of all reporting groups
11166412|NCT01973998|FG000|Participant Flow|Roflumilast|"500 ug tablet daily for 180 days~Roflumilast: PDE4 inhibitor"
11166413|NCT01973998|FG001|Participant Flow|Placebo|"Placebo 1 tablet daily x 180 days~Placebo: Inactive substance."
11166414|NCT01973998|OG000|Outcome|Roflumilast|"500 ug tablet daily for 180 days~Roflumilast: PDE4 inhibitor"
11166415|NCT01973998|OG001|Outcome|Placebo|"Placebo 1 tablet daily x 180 days~Placebo: Inactive substance."
11166416|NCT01973998|EG000|Reported Event|Roflumilast|"500 ug tablet daily for 180 days~Roflumilast: PDE4 inhibitor"
11166417|NCT01973998|EG001|Reported Event|Placebo|"Placebo 1 tablet daily x 180 days~Placebo: Inactive substance."
11166418|NCT01974050|BG000|Baseline|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
11166419|NCT01974050|FG000|Participant Flow|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
11166420|NCT01974050|OG000|Outcome|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
11166421|NCT01974050|EG000|Reported Event|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
11166422|NCT01974089|BG000|Baseline|Pneumonia and Dysphagia|Patients with community acquired pneumonia and oropharyngeal dysphagia
11166423|NCT01974089|BG001|Baseline|Pneumonia|Patients with community acquired pneumonia
11166424|NCT01974089|BG002|Baseline|Total|Total of all reporting groups
11166425|NCT01974089|FG000|Participant Flow|Pneumonia and Dysphagia|Patients with community acquired pneumonia and oropharyngeal dysphagia
11166426|NCT01974089|FG001|Participant Flow|Pneumonia|Patients with community acquired pneumonia
11166427|NCT01974089|OG000|Outcome|Pneumonia and Dysphagia|Patients with community acquired pneumonia and oropharyngeal dysphagia
11166428|NCT01974089|OG001|Outcome|Pneumonia|Patients with community acquired pneumonia
11166429|NCT01974089|OG000|Outcome|Pneumonia and Dysphagia|"Patients with community aquired pneumonia and oropharyngea dysphagia~Dysphagia: Oropharyngeal dysphagia assessed by Volume-Viscosity Svallowing Test"
11166430|NCT01974089|OG001|Outcome|Pneumonia|Patients with community aquired pneumonia
11166431|NCT01974089|EG000|Reported Event|Pneumonia and Dysphagia|Patients with community acquired pneumonia and oropharyngeal dysphagia
11166432|NCT01974089|EG001|Reported Event|Pneumonia|Patients with community acquired pneumonia
11166433|NCT01974102|BG000|Baseline|Lifestyle|"Both active and control groups will receive counseling on nutrition and physical activity.~Lifestyle counseling: Active and control participants will receive nutritional and physical activity counseling."
11166434|NCT01974102|BG001|Baseline|Prevention Intervention|"Active group will receive 8 weeks of mindfulness based parenting stress intervention~Lifestyle counseling: Active and control participants will receive nutritional and physical activity counseling.~Mindfulness Based Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention."
11166435|NCT01974102|BG002|Baseline|Total|Total of all reporting groups
11166436|NCT01974102|FG000|Participant Flow|Lifestyle|"Both active and control groups will receive counseling on nutrition and physical activity.~Lifestyle counseling: Active and control participants will receive nutritional and physical activity counseling."
11166437|NCT01974102|FG001|Participant Flow|Prevention Intervention|"Active group will receive 8 weeks of mindfulness based parenting stress intervention~Lifestyle counseling: Active and control participants will receive nutritional and physical activity counseling.~Mindfulness Based Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention"
11166438|NCT01974102|OG000|Outcome|Lifestyle|Session attendance in Control group
11166439|NCT01974102|OG001|Outcome|Prevention Intervention|Session Attendance in Mindfulness based Intervention group
11166440|NCT01974102|OG000|Outcome|Lifestyle|Change in Child BMI Percentile from Post- to Pre- treatment in Control group
11166441|NCT01974102|OG001|Outcome|Prevention Intervention|Change in Child BMI Percentile from Post- to Pre- treatment in Mindfulness based Intervention group
11166442|NCT01974102|EG000|Reported Event|Lifestyle|"This group will receive attendance control weekly with attendance in a group to watch a relaxing video and generate discussion.~Lifestyle counseling: Weekly nutritional and physical activity counseling."
11166443|NCT01974102|EG001|Reported Event|Prevention Intervention|"Active group will receive 8 weeks of parenting mindfully for health (PMH) plus nutrition and physical activity (N) counseling~Lifestyle counseling: weekly Nutritional and physical activity counseling.~Mindfulness Based Parenting Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention."
11350928|NCT04015232|OG002|Outcome|US Neulasta Dose 1|"US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~US Neulasta: FDA approved pegfilgrastim innovator product."
11350929|NCT04015232|OG003|Outcome|US Neulasta Dose 2|"US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~US Neulasta: FDA approved pegfilgrastim innovator product."
11350930|NCT04015232|EG000|Reported Event|INTP5 Biosimilar Product|"INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~INTP5: A pegfilgrastim biosimilar to US Neulasta."
11350931|NCT04015232|EG001|Reported Event|US Neulasta Reference Product|"US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~US Neulasta: FDA approved pegfilgrastim innovator product."
11350932|NCT04016623|BG000|Baseline|Overall Study|Total Participants
11350933|NCT04016623|FG000|Participant Flow|Test Contact Lenses / Control Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye for 1 hour.~Four different powers of test and control lens were used. There was a 15-minute wash-out period between the two lens pairs~1-day toric test contact lens 1: Invigor 1-day toric test contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090~1-day toric control contact lens 1: somofilcon A 1-day toric control contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090"
11350934|NCT04016623|OG000|Outcome|Test Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined.~1-day toric test contact lens: Invigor 1-day toric test contact lens.~Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350935|NCT04016623|OG001|Outcome|Control Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined.~1-day toric control contact lens: somofilcon A 1-day toric control contact lens.~Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350936|NCT04016623|OG000|Outcome|Test Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined.~1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350937|NCT04016623|OG001|Outcome|Control Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric control contact lens: somofilcon A 1-day toric control contact lens.~Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11166444|NCT01974141|BG000|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166445|NCT01974141|BG001|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166446|NCT01974141|BG002|Baseline|Total|Total of all reporting groups
11166447|NCT01974141|FG000|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166448|NCT01974141|FG001|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166449|NCT01974141|OG000|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11350938|NCT04016623|OG000|Outcome|Test Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350939|NCT04016623|OG000|Outcome|Test Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric test contact lens 1: Invigor 1-day toric test contact lens.~Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350940|NCT04016623|OG000|Outcome|Test Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350941|NCT04016623|OG000|Outcome|Test Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric test contact lens 1: Inigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350942|NCT04016623|OG001|Outcome|Control Contact Lens|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric control contact lens: somofilcon A 1-day toric control contact lens.~Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350943|NCT04016623|OG001|Outcome|Control Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric control contact lens: somofilcon A 1-day toric control contact lens.~Data for all 4 pairs were combined and analyzed (n=40 Contact lenses)."
11350944|NCT04016623|OG000|Outcome|Overall Study|Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
10887849|NCT00503308|BG002|Baseline|Total|Total of all reporting groups
11229326|NCT02397057|FG001|Participant Flow|Normal Saline|"IV Placebo (15ml of Normal Saline) IV push at 2ml/minute~Placebo"
11229327|NCT02397057|OG000|Outcome|Injectafer|"Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.~Injectafer"
11229328|NCT02397057|OG001|Outcome|Normal Saline|"IV Placebo (15ml of Normal Saline) IV push at 2ml/minute~Placebo"
11229329|NCT02397057|EG000|Reported Event|Injectafer|"Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.~Injectafer"
11229330|NCT02397057|EG001|Reported Event|Normal Saline|"IV Placebo (15ml of Normal Saline) IV push at 2ml/minute~Placebo"
11229331|NCT02397096|BG000|Baseline|Immediate Switch Group (ISG)|Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA will switch on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
11229332|NCT02397096|BG001|Baseline|Delayed Switch Group (DSG)|Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they will switch to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
11229333|NCT02397096|BG002|Baseline|Total|Total of all reporting groups
11229334|NCT02397096|FG000|Participant Flow|Immediate Switch Group (ISG)|Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA will switch on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
11229335|NCT02397096|FG001|Participant Flow|Delayed Switch Group (DSG)|Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they will switch to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
11229336|NCT02397096|OG000|Outcome|Immediate Switch Group (ISG)|Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA will switch on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
11229337|NCT02397096|OG001|Outcome|Delayed Switch Group (DSG)|Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they will switch to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
11229338|NCT02397096|OG000|Outcome|Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG)|Participants receiving continuous antiretroviral therapy with a ritonavir-boosted, PI-based regimen for >=6 months with undetectable HIV-1 RNA will switch on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
11229339|NCT02397096|OG001|Outcome|Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG)|Participants receiving continuous antiretroviral therapy with a ritonavir-boosted, PI-based regimen for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they will switch to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
11229340|NCT02397096|EG000|Reported Event|Baseline Regimen DSG (Study Weeks 0-24)|Participants in the delayed switch group (DSG) that received the baseline regimen of continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir (EVG) or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for 24 weeks.
11229341|NCT02397096|EG001|Reported Event|DOR/3TC/TDF QD DSG (Study Weeks 24-48)|Participants in the delayed switch group (DSG) that received continuous antiretroviral therapy with an oral tablet of doravirine (DOR)/lamivudine (3TC) /tenofovir disoproxil fumarate (TDF) once daily from study week 24 to week 48.
11229342|NCT02397096|EG002|Reported Event|DOR/3TC/TDF QD ISG (Study Weeks 0-48)|Participants in the immediate switch group (ISG) that received continuous antiretroviral therapy with an oral tablet of doravirine (DOR)/lamivudine (3TC) /tenofovir disoproxil fumarate (TDF) once daily for 48 weeks.
11233912|NCT02431533|FG000|Participant Flow|Probiotic PX0612|"PX0612 is a probiotic contained in a veggie capsule.~PX0612: PX0612 is a probiotic contained in a veggie capsule."
11350945|NCT04016623|OG000|Outcome|Overall Study|Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used. Data for all 4 pairs were combined and analyzed (n=40 Contact Lenses).
11350946|NCT04016623|OG000|Outcome|Test Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 Contact lenses)."
11350947|NCT04016623|OG001|Outcome|Control Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used. Both lens type and powers were randomized.~1-day toric control contact lens: somofilcon A 1-day toric control contact lens.~Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350948|NCT04016623|OG001|Outcome|Control Contact Lense|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric control contact lens: somofilcon A 1-day toric control contact lens.~Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350949|NCT04016623|OG000|Outcome|Overall Study|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used.~1-day toric test contact lens 1: Invigor 1-day toric test contact lens~1-day toric control contact lens 1: somofilcon A 1-day toric control contact lens Data for all 4 pairs were combined and analyzed (n=40 contact lenses)."
11350950|NCT04016623|EG000|Reported Event|Test Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and the data was combined as the primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.~1-day toric test contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090"
11350951|NCT04016623|EG001|Reported Event|Control Contact Lenses|"Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and the data was combined as the primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.~1-day toric control contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090"
11350952|NCT04013737|BG000|Baseline|Patients and Public|"Exploration of patient and public engagement with antibiotic decision making in secondary care. Qualitative evaluation and co-design of interventions. Prospective evaluation of intervention.~EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing."
11350953|NCT04013737|BG001|Baseline|Prescribers|"Quantitative and qualitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making.~EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing."
11350954|NCT04013737|BG002|Baseline|Total|Total of all reporting groups
11350955|NCT04013737|FG000|Participant Flow|Patients and Public|Prospective evaluation of knowledge and understanding of infections pre- and post- a patient communication intervention.
11350956|NCT04013737|FG001|Participant Flow|Prescribers|"Quantitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making.~EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing."
11350957|NCT04013737|OG000|Outcome|Appropriateness of Antibiotic Prescribing|Proportion of appropriate recommendations made using the case-based-reasoning algorithm out of 224 prescriptions input into the system by participants.
11350958|NCT04013737|OG000|Outcome|Improvement in Short Term Knowledge/Understanding|Compared using pre- and post- intervention questionnaire
11350959|NCT04013737|EG000|Reported Event||
11350960|NCT04014062|BG000|Baseline|INTP5 Period I, US Neulasta Period II Crossover|"Period I: Subjects received a single dose of INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~Period II: After the first treatment cycle and a six week wash out period, patients received a single dose of US Neulasta.~INTP5: INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.~US Neulasta: US Neulasta: FDA-approved pegfilgrastim innovator product."
11350961|NCT04014062|BG001|Baseline|US Neulasta Period I, INTP5 Period II Crossover|"Period I: Subjects received a single dose US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~Period II: After the first treatment cycle and a six week wash out period, patients received a single dose of INTP5.~INTP5: INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.~US Neulasta: US Neulasta: FDA-approved pegfilgrastim innovator product."
11350962|NCT04014062|BG002|Baseline|Total|Total of all reporting groups
11350963|NCT04014062|FG000|Participant Flow|INTP5 Period I, US Neulasta Period II Crossover|"Period I: Subjects received a single dose of INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~Period II: After the first treatment cycle and a six week wash out period, patients received a single dose of US Neulasta.~INTP5: INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.~US Neulasta: US Neulasta: FDA-approved pegfilgrastim innovator product."
11166450|NCT01974141|OG001|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11229343|NCT02397096|EG003|Reported Event|ALL DOR: DOR/3TC/TDF ISG (Weeks 0-48)+DSG (Weeks 24-48)|"Participants in the immediate switch group (ISG) that received continuous antiretroviral therapy with an oral tablet of doravirine (DOR)/lamivudine (3TC) /tenofovir disoproxil fumarate (TDF) once daily for 48 weeks.~AND Participants in the delayed switch group (DSG) that received continuous antiretroviral therapy with an oral tablet of doravirine (DOR)/lamivudine (3TC) /tenofovir disoproxil fumarate (TDF) once daily from study week 24 to week 48."
11229344|NCT02397122|BG000|Baseline|CAF+CTG+PRF|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1 The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group and the CAF was primarily closed.
11229345|NCT02397122|BG001|Baseline|CAF+CTG|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1 The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. CTG was placed over the exposed root surface and the CAF was primarily closed onto it.
11229346|NCT02397122|BG002|Baseline|Total|Total of all reporting groups
11229347|NCT02397122|FG000|Participant Flow|CAF+CTG+PRF|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
11229348|NCT02397122|FG001|Participant Flow|CAF+CTG|"coronally advanced flap + connective tissue graft~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft"
11229349|NCT02397122|OG000|Outcome|PRF+CAF+CTG|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
11229350|NCT02397122|OG001|Outcome|CAF+CTG|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
11229351|NCT02397122|OG000|Outcome|CAF+CTG+PRF|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
11229352|NCT02397122|OG001|Outcome|CAF+CTG|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft"
11229353|NCT02397122|OG000|Outcome|CAF+CTG+PRF|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. PRF was prepared from 10 ml venous blood and the gel part was placed under CTG harvested from the palate. Flap was coronally advanced and CTG+PRF was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
11229354|NCT02397122|OG001|Outcome|CAF+CTG|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. CTG was harvested from the palate and placed over the recession defect. Flap was coronally advanced and CTG was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
11229355|NCT02397122|EG000|Reported Event|PRF+CAF+CTG|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
11233913|NCT02431533|FG001|Participant Flow|Di-Calcium Phosphate|"Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate~Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate"
11229356|NCT02397122|EG001|Reported Event|CAF+CTG|"coronally advanced flap + connective tissue graft~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft"
11229357|NCT02397265|BG000|Baseline|All Participant|Crossover study, all participant
11229358|NCT02397265|FG000|Participant Flow|First Bihormonal Closed Loop|Bihormonal Closed Loop first, then Standard Opened Loop Pump, then Insulin
11229359|NCT02397265|FG001|Participant Flow|First Standard Opened Loop Pump|First Standard Opened Loop Pump, then Bihormonal Closed Loop, then Insulin
11229360|NCT02397265|FG002|Participant Flow|First Insulin Only|First Insulin, then Standard Opened Loop Pump, then Bihormonal Closed Loop
11229361|NCT02397265|OG000|Outcome|Bihormonal Closed Loop|"Bi-hormonal closed loop pump will be used in the exercise and mixed meal substudies~Bi-hormonal closed loop pump: Using a bio-inspired artificial pancreas consisting of a bi-hormonal closed loop pump"
11229362|NCT02397265|OG001|Outcome|Standard Opened Loop Pump|"Standard opened loop pump will be used in the exercise and mixed meal substudies~Standard opened loop pump: Using a standard opened loop pump"
11229363|NCT02397265|OG002|Outcome|Insulin Only|Insulin only closed loop
11229364|NCT02397265|EG000|Reported Event|Bihormonal Closed Loop|"Bi-hormonal closed loop pump will be used in the exercise and mixed meal substudies~Bi-hormonal closed loop pump: Using a bio-inspired artificial pancreas consisting of a bi-hormonal closed loop pump"
11229365|NCT02397265|EG001|Reported Event|Standard Opened Loop Pump|"Standard opened loop pump will be used in the exercise and mixed meal substudies~Standard opened loop pump: Using a standard opened loop pump"
11229366|NCT02397265|EG002|Reported Event|Insulin Only|Insulin only closed loop
11229367|NCT02397278|BG000|Baseline|Platelet Rich Plasma (PRP)|"Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.~Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy."
11229368|NCT02397278|BG001|Baseline|Conventional Therapy|Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
11229369|NCT02397278|BG002|Baseline|Total|Total of all reporting groups
11229370|NCT02397278|FG000|Participant Flow|Platelet Rich Plasma (PRP)|"Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.~Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy."
11229371|NCT02397278|FG001|Participant Flow|Conventional Therapy|Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
11229372|NCT02397278|OG000|Outcome|Platelet Rich Plasma (PRP)|"Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.~Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy."
11229373|NCT02397278|OG001|Outcome|Conventional Therapy|Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
11229374|NCT02397278|EG000|Reported Event|Platelet Rich Plasma (PRP)|"Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.~Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy."
11229375|NCT02397278|EG001|Reported Event|Conventional Therapy|Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
11229376|NCT02397291|BG000|Baseline|Placebo/Control Group|"At the time of the elective cesarean section, a blood sample of 0.5 ml will be obtained from a maternal heated hand vein at the time the umbilical cord is clamped. Then, the umbilical cord will be doubly clamped to isolate a segment. The umbilical artery and vein will be sampled for 0.5 ml of blood. There are no stable isotopes infused. Heating the maternal hand vein allows it to be arterialized. These patients are separate from those required for the stable isotope studies listed below.~Placebo: placebo"
11233914|NCT02431533|OG000|Outcome|Probiotic PX0612|"PX0612 is a probiotic contained in a veggie capsule.~PX0612: PX0612 is a probiotic contained in a veggie capsule."
11233915|NCT02431533|OG001|Outcome|Di-Calcium Phosphate|"Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate~Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate"
11229377|NCT02397291|BG001|Baseline|Study Group (IUGR)|"Prior to the elective cesarean section, 2 samples from the patient's heated hand vein are obtained to establish a baseline for the compounds. Next, a primed constant infusion containing the stable isotopes of mannose and myoinositol is begun in a peripheral IV of the mother. This is continued approximately 2 hours until the Cesarean section is complete and the umbilical cord samples are obtained. An additional 3 samples are obtained from the patient's heated hand vein: 1 at the start of the cesarean section, 1 at the time the fetus is delivered, and 1 at the time the umbilical cord samples are obtained.~Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.~Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV."
11229378|NCT02397291|BG002|Baseline|Total|Total of all reporting groups
11229379|NCT02397291|FG000|Participant Flow|Placebo/Control Group|"At the time of the elective cesarean section, a blood sample of 0.5 ml will be obtained from a maternal heated hand vein at the time the umbilical cord is clamped. Then, the umbilical cord will be doubly clamped to isolate a segment. The umbilical artery and vein will be sampled for 0.5 ml of blood. There are no stable isotopes infused. Heating the maternal hand vein allows it to be arterialized. These patients are separate from those required for the stable isotope studies listed below.~Placebo: placebo"
11229380|NCT02397291|FG001|Participant Flow|Study Group (IUGR)|"Prior to the elective cesarean section, 2 samples from the patient's heated hand vein are obtained to establish a baseline for the compounds. Next, a primed constant infusion containing the stable isotopes of mannose and myoinositol is begun in a peripheral IV of the mother. This is continued approximately 2 hours until the Cesarean section is complete and the umbilical cord samples are obtained. An additional 3 samples are obtained from the patient's heated hand vein: 1 at the start of the cesarean section, 1 at the time the fetus is delivered, and 1 at the time the umbilical cord samples are obtained.~Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.~Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV."
11229381|NCT02397291|OG000|Outcome|Placebo/Control Group|"At the time of the elective cesarean section, a blood sample of 0.5 ml will be obtained from a maternal heated hand vein at the time the umbilical cord is clamped. Then, the umbilical cord will be doubly clamped to isolate a segment. The umbilical artery and vein will be sampled for 0.5 ml of blood. There are no stable isotopes infused. Heating the maternal hand vein allows it to be arterialized. These patients are separate from those required for the stable isotope studies listed below.~Placebo: placebo"
11229382|NCT02397291|OG001|Outcome|Study Group (IUGR)|"Prior to the elective cesarean section, 2 samples from the patient's heated hand vein are obtained to establish a baseline for the compounds. Next, a primed constant infusion containing the stable isotopes of mannose and myoinositol is begun in a peripheral IV of the mother. This is continued approximately 2 hours until the Cesarean section is complete and the umbilical cord samples are obtained. An additional 3 samples are obtained from the patient's heated hand vein: 1 at the start of the cesarean section, 1 at the time the fetus is delivered, and 1 at the time the umbilical cord samples are obtained.~Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.~Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV."
11229383|NCT02397291|EG000|Reported Event|Part 1: Measurements of Maternal and Fetal Concentrations|"At the time of the elective cesarean section, a blood sample of 0.5 ml will be obtained from a maternal heated hand vein at the time the umbilical cord is clamped. Then, the umbilical cord will be doubly clamped to isolate a segment. The umbilical artery and vein will be sampled for 0.5 ml of blood. There are no stable isotopes infused. Heating the maternal hand vein allows it to be arterialized. These patients are separate from those required for the stable isotope studies listed below.~Placebo: placebo"
11229384|NCT02397291|EG001|Reported Event|Part 2: Stable Isotope Studies|"Prior to the elective cesarean section, 2 samples from the patient's heated hand vein are obtained to establish a baseline for the compounds. Next, a primed constant infusion containing the stable isotopes of mannose and myoinositol is begun in a peripheral IV of the mother. This is continued approximately 2 hours until the Cesarean section is complete and the umbilical cord samples are obtained. An additional 3 samples are obtained from the patient's heated hand vein: 1 at the start of the cesarean section, 1 at the time the fetus is delivered, and 1 at the time the umbilical cord samples are obtained.~Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.~Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV."
11229385|NCT02397408|BG000|Baseline|Diagnostic 11C- and 18F-choline PET/MR Imaging|Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging
11229386|NCT02397408|FG000|Participant Flow|Diagnostic 11C- and 18F-choline PET/MR Imaging|Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging
11229387|NCT02397408|OG000|Outcome|Choline PET/MR|"11C-Choline: 370MBq Intravenously 18F-Choline: 3MBq/kg Intravenously~Choline PET/MR"
11229388|NCT02397408|EG000|Reported Event|Diagnostic 11C- and 18F-choline PET/MR Imaging|Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging
11229389|NCT02397447|BG000|Baseline|Momordica Charantia|"Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days~Momordica charantia: Momordica Charantia: 2000 mg per day for three months"
11229390|NCT02397447|BG001|Baseline|Placebo|"Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days~Placebo: Placebo: 2000 mg per day for three months"
11229391|NCT02397447|BG002|Baseline|Total|Total of all reporting groups
11229392|NCT02397447|FG000|Participant Flow|Momordica Charantia|"Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days~Momordica charantia: Momordica Charantia: 2000 mg per day for three months"
11229393|NCT02397447|FG001|Participant Flow|Placebo|"Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days~Placebo: Placebo: 2000 mg per day for three months"
11233916|NCT02431533|EG000|Reported Event|Probiotic PX0612|"PX0612 is a probiotic contained in a veggie capsule.~PX0612: PX0612 is a probiotic contained in a veggie capsule."
11229394|NCT02397447|OG000|Outcome|Momordica Charantia|"Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days~Momordica charantia: Momordica Charantia: 2000 mg per day for three months"
11229395|NCT02397447|OG001|Outcome|Placebo|"Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days~Placebo: Placebo: 2000 mg per day for three months"
11229396|NCT02397447|EG000|Reported Event|Momordica Charantia|"Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days~Momordica charantia: Momordica Charantia: 2000 mg per day for three months"
11229397|NCT02397447|EG001|Reported Event|Placebo|"Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days~Placebo: Placebo: 2000 mg per day for three months"
11229398|NCT02397460|BG000|Baseline|Cohort 1: PBO→Gefapixant 300 mg→PBO→Gefapixant 300 mg/Healthy|Healthy participants in Cohort 1/Sequence A received single doses of placebo (PBO) on Day 1 of Periods 1 and 3 and single doses of gefapixant 300 mg on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229399|NCT02397460|BG001|Baseline|Cohort 1: Gefapixant 300 mg→PBO→Gefapixant 300 mg→PBO/Healthy|Healthy participants in Cohort 1/Sequence B received single doses of gefapixant 300 mg on Day 1 of Periods 1 and 3 and singles doses of placebo on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229400|NCT02397460|BG002|Baseline|Cohort 1: PBO→Gefapixant 300 mg→PBO→Gefapixant 300 mg/CC|Participants with chronic cough (CC) in Cohort 1/Sequence A received singles doses of placebo on Day 1 of Periods 1 and 3 and single doses of gefapixant 300 mg on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229401|NCT02397460|BG003|Baseline|Cohort 1: Gefapixant 300 mg→PBO→Gefapixant 300 mg→PBO/CC|Participants with chronic cough in Cohort 1/Sequence B received singles doses of gefapixant 300 mg on Day 1 of Periods 1 and 3 and single doses of placebo on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229402|NCT02397460|BG004|Baseline|Cohort 2: PBO→Gefapixant 50 mg→PBO→Gefapixant 50 mg/Healthy|Healthy participants in Cohort 2/Sequence A received singles doses of placebo on Day 1 of Periods 1 and 3 and single doses of gefapixant 50 mg on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229403|NCT02397460|BG005|Baseline|Cohort 2: Gefapixant 50 mg→PBO→Gefapixant 50 mg→PBO/Healthy|Healthy participants in Cohort 2/Sequence B received single doses of gefapixant 50 mg on Day 1 of Periods 1 and 3 and single doses of placebo on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229404|NCT02397460|BG006|Baseline|Cohort 2: PBO→Gefapixant 50 mg→PBO→Gefapixant 50 mg/CC|Participants with chronic cough in Cohort 2/Sequence A received singles doses of placebo on Day of Periods 1 and 3 and singles doses of gefapixant 50 mg on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229405|NCT02397460|BG007|Baseline|Cohort 2: Gefapixant 50 mg→PBO→Gefapixant 50 mg→PBO/CC|Participants with chronic cough in Cohort 2/Sequence B received singles doses of gefapixant 50 mg on Day 1 of Periods 1 and 3 and singles doses of placebo on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229406|NCT02397460|BG008|Baseline|Total|Total of all reporting groups
11229407|NCT02397460|FG000|Participant Flow|Cohort 1: PBO→Gefapixant 300 mg→PBO→Gefapixant 300 mg/Healthy|Healthy participants in Cohort 1/Sequence A received single doses of placebo (PBO) on Day 1 of Periods 1 and 3 and single doses of gefapixant 300 mg on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229408|NCT02397460|FG001|Participant Flow|Cohort 1: Gefapixant 300 mg→PBO→Gefapixant 300 mg→PBO/Healthy|Healthy participants in Cohort 1/Sequence B received single doses of gefapixant 300 mg on Day 1 of Periods 1 and 3 and singles doses of placebo on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229409|NCT02397460|FG002|Participant Flow|Cohort 1: PBO→Gefapixant 300 mg→PBO→Gefapixant 300 mg/CC|Participants with chronic cough (CC) in Cohort 1/Sequence A received singles doses of placebo on Day 1 of Periods 1 and 3 and single doses of gefapixant 300 mg on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229410|NCT02397460|FG003|Participant Flow|Cohort 1: Gefapixant 300 mg→PBO→Gefapixant 300 mg→PBO/CC|Participants with chronic cough in Cohort 1/Sequence B received singles doses of gefapixant 300 mg on Day 1 of Periods 1 and 3 and single doses of placebo on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229411|NCT02397460|FG004|Participant Flow|Cohort 2: PBO→Gefapixant 50 mg→PBO→Gefapixant 50 mg/Healthy|Healthy participants in Cohort 2/Sequence A received singles doses of placebo on Day 1 of Periods 1 and 3 and single doses of gefapixant 50 mg on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229412|NCT02397460|FG005|Participant Flow|Cohort 2: Gefapixant 50 mg→PBO→Gefapixant 50 mg→PBO/Healthy|Healthy participants in Cohort 2/Sequence B received single doses of gefapixant 50 mg on Day 1 of Periods 1 and 3 and single doses of placebo on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229413|NCT02397460|FG006|Participant Flow|Cohort 2: PBO→Gefapixant 50 mg→PBO→Gefapixant 50 mg/CC|Participants with chronic cough in Cohort 2/Sequence A received singles doses of placebo on Day of Periods 1 and 3 and singles doses of gefapixant 50 mg on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11350964|NCT04014062|FG001|Participant Flow|US Neulasta Period I, INTP5 Period II Crossover|"Period I: Subjects received a single dose US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~Period II: After the first treatment cycle and a six week wash out period, patients received a single dose of INTP5.~INTP5: INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.~US Neulasta: US Neulasta: FDA-approved pegfilgrastim innovator product."
11350965|NCT04014062|OG000|Outcome|INTP5 Treatment|INTP5: A proposed pegfilgrastim biosimiar to US Neulasta. Outcomes Measures were grouped by treatment. This Group includes patients that received INTP5 in either Period I or Period II.
11350966|NCT04014062|OG001|Outcome|US Neulasta Treatment|US Neulasta: FDA approved pegfilgrastim innovator product. Outcomes Measures were grouped by treatment. This Group includes patients that received US Neulasta in either Period I or Period II.
11350967|NCT04014062|OG000|Outcome|INTP5 Treatment|INTP5: A proposed pegfilgrastim biosimilar to US Neulasta. Outcomes Measures were grouped by treatment. This Group includes patients that received INTP5 in either Period I or Period II.
11350968|NCT04014062|OG000|Outcome|INTP5 Treatment|"INTP5: A proposed pegfilgrastim biosimiar to US Neulasta.~Outcomes Measures were grouped by treatment. This Group includes patients that received INTP5 in either Period I or Period II."
11350969|NCT04014062|OG001|Outcome|US Neulasta Treatment|"US Neulasta: FDA approved pegfilgrastim innovator product.~Outcomes Measures were grouped by treatment. This Group includes patients that received US Neulasta in either Period I or Period II."
11350970|NCT04014062|OG000|Outcome|INTP5 Treatment|"Period I: Subjects received a single dose of INTP5 subcutaneously at a dose of 6 mg/0.6 mL.~Period II: After the first treatment cycle of US Neulasta and a six week wash out period, patients received a single dose of INTP5~INTP5: A proposed pegfilgrastim biosimilar to US Neulasta. US Neulasta: FDA-approved pegfilgrastim innovator product."
11350971|NCT04014062|OG001|Outcome|US Neulasta Treatment|"Period I: Subjects received a single dose US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.~Period II: After the first treatment cycle of INTP5 and a six week wash out period, patients received a single dose of US Neulasta.~INTP5: A proposed pegfilgrastim biosimilar to US Neulasta. US Neulasta: FDA-approved pegfilgrastim innovator product."
11350972|NCT04014062|EG000|Reported Event|INTP5 Treatment|"INTP5: A proposed pegfilgrastim biosimiar to US Neulasta. Outcomes Measures were grouped by treatment. This Group includes patients that received INTP5 in either Period I or Period II.~Given that this was a crossover design, AE totals for the entire study are reported comprehensively for Period I (71 Subjects) and Period II (65 Subjects) combined for the 136 subjects who received this treatment. Due to participant dropout between treatments, the number at risk for a given treatment is lower than the starting population for the study."
11350973|NCT04014062|EG001|Reported Event|US Neulasta Treatment|"US Neulasta: FDA approved pegfilgrastim innovator product. Outcomes Measures were grouped by treatment. This Group includes patients that received US Neulasta in either Period I or Period II.~Given that this was a crossover design, AE totals for the entire study are reported comprehensively for Period I (71 Subjects) and Period II (64 Subjects) combined for the 135 subjects who received this treatment. Due to participant dropout between treatments, the number at risk for a given treatment is lower than the starting population for the study."
11350974|NCT04013789|BG000|Baseline|Overall|DACP FreshTech contact lenses and DACP contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
11350975|NCT04013789|FG000|Participant Flow|DACP FreshTech, Then DACP|DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.
11350976|NCT04013789|FG001|Participant Flow|DACP, Then DACP FreshTech|DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.
11350977|NCT04013789|OG000|Outcome|DACP FreshTech|DACP FreshTech contact lenses worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day
11350978|NCT04013789|OG001|Outcome|DACP|DACP contact lenses worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day
11350979|NCT04013789|EG000|Reported Event|DACP FreshTech - Ocular|Nelfilcon A soft contact lenses with a modified lens design worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day.
11350980|NCT04013789|EG001|Reported Event|DACP FreshTech - Systemic / Nonocular|Nelfilcon A soft contact lenses with a modified lens design worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day.
11350981|NCT04013789|EG002|Reported Event|DACP - Ocular|Nelfilcon A soft contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day.
11350982|NCT04013789|EG003|Reported Event|DACP - Systemic / Nonocular|Nelfilcon A soft contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day.
11350983|NCT04012970|BG000|Baseline|A - Intervention Then Control|Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.
11350984|NCT04012970|BG001|Baseline|B - Control Then Intervention|Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.
11350985|NCT04012970|BG002|Baseline|Total|Total of all reporting groups
11350986|NCT04012970|FG000|Participant Flow|A - Intervention Then Control|Intervention (30 minutes spinal mobilisations) received in first session, control (30 minutes lying still) received in second session.
11350987|NCT04012970|FG001|Participant Flow|B - Control Then Intervention|Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.
11350988|NCT04012970|OG000|Outcome|Intervention|Group A and Group B results for stiffness change due to the spinal mobilisation intervention.
11350989|NCT04012970|OG000|Outcome|Control|Group A and Group B results for stiffness change due to the control session.
11350990|NCT04012970|OG000|Outcome|Intervention|Group A and Group B results for tone change due to the spinal mobilisation intervention.
11350991|NCT04012970|OG000|Outcome|Control|Group A and Group B results for tone change due to the control session.
11350992|NCT04012970|OG000|Outcome|Intervention|Group A and Group B results for elasticity change due to the spinal mobilisation intervention.
11350993|NCT04012970|OG000|Outcome|Control|Group A and Group B results for elasticity change due to the control session.
11350994|NCT04012970|EG000|Reported Event|Group A - Intervention|Group A received the 30 minutes spinal mobilisations intervention in the first session.
11350995|NCT04012970|EG001|Reported Event|Group A - Control|Group A received the control (30 minutes lying still) in the second session.
11350996|NCT04012970|EG002|Reported Event|Group B - Intervention|"Group B received the control (30 minutes lying still) in the second session.~."
11350997|NCT04012970|EG003|Reported Event|Group B - Control|Group B received the 30 minutes spinal mobilisations intervention in the first session.
11350998|NCT04013191|BG000|Baseline|Adults (18-64 Years)|Participants received assigned single and multiple doses of padsevonil.
11350999|NCT04013191|BG001|Baseline|Elderly (>= 65 Years)|Participants received assigned single and multiple doses of padsevonil.
11351000|NCT04013191|BG002|Baseline|Total Title|
11351001|NCT04013191|FG000|Participant Flow|Adults (18-64 Years)|Participants received assigned single and multiple doses of padsevonil.
11351002|NCT04013191|FG001|Participant Flow|Elderly (>= 65 Years)|Participants received assigned single and multiple doses of padsevonil.
11351003|NCT04013191|OG000|Outcome|Adults (18-64 Years) (PK-PPS)|Participants received assigned single and multiple doses of padsevonil, forming the Pharmacokinetic-Per Protocol Set (PK-PPS).
11351004|NCT04013191|OG001|Outcome|Elderly (>= 65 Years) (PK-PPS)|Participants received assigned single and multiple doses of padsevonil, forming the PK-PPS.
11351005|NCT04013191|OG000|Outcome|Adults (18-64 Years) (FAS)|Participants received assigned single and multiple doses of padsevonil, forming the Full Analysis Set (FAS).
11351006|NCT04013191|OG001|Outcome|Elderly (>= 65 Years) (FAS)|Participants received assigned single and multiple doses of padsevonil, forming the FAS.
11351007|NCT04013191|EG000|Reported Event|Adults (18-64 Years) (FAS) SD Period (1A)|Participants received a single dose of padsevonil during Period (1A), forming the FAS.
11351008|NCT04013191|EG001|Reported Event|Elderly (>= 65 Years) (FAS) SD Period (1A)|Participants received a single dose of padsevonil during Period (1A), forming the FAS.
11351009|NCT04013191|EG002|Reported Event|Adults (18-64 Years) (FAS) MD Period (1B)|Participants received multiple doses of padsevonil during Period (1B), forming the FAS.
11351010|NCT04013191|EG003|Reported Event|Elderly (>= 65 Years) (FAS) MD Period (1B)|Participants received multiple doses of padsevonil during Period (1B), forming the FAS.
11351011|NCT04011631|BG000|Baseline|Patients With Cardiac Surgery|"All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.~Internal defibrillation during cardiac surgery, using the iD-system: When ventricular fibrillation of ventricular tachycardia occurs during surgery, the iD-Paddle will be applied directly to the heart. A maximum of 4 shocks are delivered to the heart to restore normal sinus rhythm. If 4 shocks are not successful standard operating procedure will be enable conform hospital protocol."
11351012|NCT04011631|FG000|Participant Flow|Patients With Cardiac Surgery|"All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.~Internal defibrillation during cardiac surgery, using the iD-system: When ventricular fibrillation of ventricular tachycardia occurs during surgery, the iD-Paddle will be applied directly to the heart. A maximum of 4 shocks are delivered to the heart to restore normal sinus rhythm. If 4 shocks are not successful standard operating procedure will be enable conform hospital protocol."
11351013|NCT04011631|OG000|Outcome|Patients With Cardiac Surgery|"All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.~Internal defibrillation during cardiac surgery, using the iD-system: When ventricular fibrillation of ventricular tachycardia occurs during surgery, the iD-Paddle will be applied directly to the heart. A maximum of 4 shocks are delivered to the heart to restore normal sinus rhythm. If 4 shocks are not successful standard operating procedure will be enable conform hospital protocol."
11351014|NCT04011631|EG000|Reported Event|Patients With Cardiac Surgery|"All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.~Internal defibrillation during cardiac surgery, using the iD-system: When ventricular fibrillation of ventricular tachycardia occurs during surgery, the iD-Paddle will be applied directly to the heart. A maximum of 4 shocks are delivered to the heart to restore normal sinus rhythm. If 4 shocks are not successful standard operating procedure will be enable conform hospital protocol."
11351015|NCT04011735|BG000|Baseline|Respimat® SMI-experienced: Maintenance With Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
11351016|NCT04011735|BG001|Baseline|Respimat® SMI-experienced: Switching to Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351017|NCT04011735|BG002|Baseline|Respimat® SMI-naïve|Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351018|NCT04011735|BG003|Baseline|Total|Total of all reporting groups
11351019|NCT04011735|FG000|Participant Flow|Respimat® SMI-experienced: Maintenance With Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
11351020|NCT04011735|FG001|Participant Flow|Respimat® SMI-experienced: Switching to Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351021|NCT04011735|FG002|Participant Flow|Respimat® SMI-naïve|Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351022|NCT04011735|OG000|Outcome|Respimat® SMI-experienced: Maintenance With Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
11351023|NCT04011735|OG001|Outcome|Respimat® SMI-experienced: Switching to Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351024|NCT04011735|OG002|Outcome|Respimat® SMI-naïve|Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351025|NCT04011735|OG000|Outcome|Respimat® SMI-experienced: Switching to Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351026|NCT04011735|OG000|Outcome|Respimat SMI-experienced Patients Switching to a Re-usable Respimat SMI at Study Entry|Respimat SMI-experienced patients switching to a re-usable Respimat SMI at study entry.
11351027|NCT04011735|EG000|Reported Event|Respimat® SMI-experienced: Maintenance With Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).
11351028|NCT04011735|EG001|Reported Event|Respimat® SMI-experienced: Switching to Re-usable SMI|Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351029|NCT04011735|EG002|Reported Event|Respimat® SMI-naïve|Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).
11351030|NCT04009577|BG000|Baseline|Cohort 1A: LEM 5 or LEM 10 (Intermittent ZOL Use)|Participants who took ZOL at least 3 nights but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11351031|NCT04009577|BG001|Baseline|Cohort 1B: LEM 5 or LEM 10 (Mixed ZOL Use)|Participants who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening Period, initially received LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11166451|NCT01974141|EG000|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166452|NCT01974141|EG001|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11351032|NCT04009577|BG002|Baseline|Cohort 2A: LEM 5 or LEM 10 (Frequent ZOL Use)|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11166453|NCT01974245|BG000|Baseline|Placebo|100 drops/week
11166454|NCT01974245|BG001|Baseline|Cholecalciferol|Cholecalciferol: 100,000 IU/week
11166455|NCT01974245|BG002|Baseline|Total|Total of all reporting groups
11166456|NCT01974245|FG000|Participant Flow|Placebo|100 drops placebo solution/week
11166457|NCT01974245|FG001|Participant Flow|Cholecalciferol|Cholecalciferol: 100,000 IU/week
11166458|NCT01974245|OG000|Outcome|Placebo|100 drops/week for 12 weeks
11166459|NCT01974245|OG001|Outcome|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
11351033|NCT04009577|BG003|Baseline|Cohort 2B: LEM 10 or LEM 5 (Frequent ZOL Use)|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM10 or LEM5 tablet down titrated (due to tolerability), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM10 or LEM5 tablet down titrated (due to tolerability), orally, once at night for up to 12 weeks in the Extension Phase.
11351034|NCT04009577|BG004|Baseline|Total|Total of all reporting groups
11351035|NCT04009577|FG000|Participant Flow|Cohort 1A: LEM 5 or LEM 10 (Intermittent ZOL Use)|Participants who took zolpidem tartrate (ZOL) at least 3 nights but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received lemborexant 5 milligram (mg) (LEM5) or 10 mg (LEM10) tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11351036|NCT04009577|FG001|Participant Flow|Cohort 1B: LEM 5 or LEM 10 (Mixed ZOL Use)|Participants who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening Period, initially received LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11351037|NCT04009577|FG002|Participant Flow|Cohort 2A: LEM 5 or LEM 10 (Frequent ZOL Use)|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11351038|NCT04009577|FG003|Participant Flow|Cohort 2B: LEM 10 or LEM 5 (Frequent ZOL Use)|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM10 or LEM5 tablet down titrated (due to tolerability), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM10 or LEM5 tablet down titrated (due to tolerability), orally, once at night for up to 12 weeks in the Extension Phase.
11351039|NCT04009577|OG000|Outcome|Overall Cohort|Participants who took ZOL at least 3 but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period or who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening or who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM5 or LEM10 tablet (as per titration schedule), orally once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed 2 weeks in Titration Period of Core Study continued to receive LEM5 or LEM10 (as per titration schedule) tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11351040|NCT04009577|OG000|Outcome|Cohort 1A: LEM 5 or LEM 10 (Intermittent ZOL Use)|Participants who took ZOL at least 3 nights but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11351041|NCT04009577|OG001|Outcome|Cohort 1B: LEM 5 or LEM 10 (Mixed ZOL Use)|Participants who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening Period, initially received LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11351042|NCT04009577|OG002|Outcome|Cohort 2A: LEM 5 or LEM 10 (Frequent ZOL Use)|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM5 or LEM10 tablet up titrated (in case previous dose was ineffective), orally, once at night for up to 12 weeks in the Extension Phase.
11166460|NCT01974245|EG000|Reported Event|Placebo|100 drops/week for 12 weeks
11166461|NCT01974245|EG001|Reported Event|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
11351043|NCT04009577|OG003|Outcome|Cohort 2B: LEM 10 or LEM 5 (Frequent ZOL Use)|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM10 or LEM5 tablet down titrated (due to tolerability), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM10 or LEM5 tablet down titrated (due to tolerability), orally, once at night for up to 12 weeks in the Extension Phase.
11351044|NCT04009577|OG003|Outcome|Overall Cohort|Participants who took ZOL at least 3 but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period or who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening or who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM5 or LEM10 tablet (as per titration schedule), orally once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed 2 weeks in Titration Period of Core Study continued to receive LEM5 or LEM10 (as per titration schedule) tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11166462|NCT01974323|BG000|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166463|NCT01974323|BG001|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11351045|NCT04009577|OG000|Outcome|Cohort 2B: LEM 10 or LEM 5 (Frequent ZOL Use)|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM10 or LEM5 tablet down titrated (due to tolerability), orally, once at night for up to 2 weeks in Titration Period of Core Study and continued to receive LEM10 or LEM5 tablet down titrated (due to tolerability), orally, once at night for up to 12 weeks in the Extension Phase.
11166464|NCT01974323|BG002|Baseline|Total|Total of all reporting groups
11166465|NCT01974323|FG000|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166466|NCT01974323|FG001|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166467|NCT01974323|OG000|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166468|NCT01974323|OG001|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166469|NCT01974323|EG000|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166470|NCT01974323|EG001|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
11166471|NCT01974687|BG000|Baseline|Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)|Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
11166472|NCT01974687|BG001|Baseline|Group A: Uprifosbuvir 10 mg (Cohort 1a)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166473|NCT01974687|BG002|Baseline|Group A: Uprifosbuvir 25 mg (Cohort 2a)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11166474|NCT01974687|BG003|Baseline|Group A: Uprifosbuvir 150 mg (Cohort 4a)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
11166475|NCT01974687|BG004|Baseline|Group A: Uprifosbuvir 300 mg (Cohort 5a)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166476|NCT01974687|BG005|Baseline|Group A: Placebo (Cohort 6a)|Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
11166477|NCT01974687|BG006|Baseline|Group A: Uprifosbuvir 300 mg (Cohort 6a)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166478|NCT01974687|BG007|Baseline|Group B: Uprifosbuvir 10 mg (Cohort 1b)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166479|NCT01974687|BG008|Baseline|Group B: Uprifosbuvir 25 mg (Cohort 2b)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11166480|NCT01974687|BG009|Baseline|Group B: Uprifosbuvir 50 mg (Cohort 3b)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166481|NCT01974687|BG010|Baseline|Group B: Uprifosbuvir 150 mg (Cohort 4b)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166482|NCT01974687|BG011|Baseline|Group B: Uprifosbuvir 300 mg (Cohort 5b)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166483|NCT01974687|BG012|Baseline|Groups C & D: Uprifosbuvir 50 mg (Capsule)|Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
11166484|NCT01974687|BG013|Baseline|Groups C & D: Uprifosbuvir 150 mg (Capsule)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
11166485|NCT01974687|BG014|Baseline|Groups C & D: Uprifosbuvir 250 mg (Capsule)|Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
11166486|NCT01974687|BG015|Baseline|Groups C & D: Uprifosbuvir 300 mg (Capsule)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166487|NCT01974687|BG016|Baseline|Groups C & D: Uprifosbuvir 400 mg (Capsule)|Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
11166488|NCT01974687|BG017|Baseline|Groups C & D: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
11166489|NCT01974687|BG018|Baseline|Groups C & D: Uprifosbuvir 450 mg (Tablet)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166490|NCT01974687|BG019|Baseline|Groups C & D: Placebo (Pooled)|Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
11166491|NCT01974687|BG020|Baseline|Group E: Uprifosbuvir 150 mg (Cohort 1e)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166492|NCT01974687|BG021|Baseline|Group E: Uprifosbuvir 300 mg (Cohort 2e)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166493|NCT01974687|BG022|Baseline|Group E: Uprifosbuvir 450 mg (Cohort 3e)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166494|NCT01974687|BG023|Baseline|Group F: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
11166495|NCT01974687|BG024|Baseline|Group A: Uprifosbuvir 50 mg (Cohort 3a)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166496|NCT01974687|BG025|Baseline|Total|Total of all reporting groups
11166497|NCT01974687|FG000|Participant Flow|Group A: Uprifosbuvir 10 mg (Cohort 1a)|Participants were administered a single dose of uprifosbuvir (MK-3682/IDX21437) 10 mg as oral capsules under fasted conditions.
11166498|NCT01974687|FG001|Participant Flow|Group A: Uprifosbuvir 25 mg (Cohort 2a)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11351046|NCT04009577|OG004|Outcome|Overall Cohort|Participants who took ZOL at least 3 but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period or who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening or who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM5 or LEM10 tablet (as per titration schedule), orally once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed 2 weeks in Titration Period of Core Study continued to receive LEM5 or LEM10 (as per titration schedule) tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11351047|NCT04009577|EG000|Reported Event|Cohort 1A (Core Study): LEM 5|Participants who took ZOL at least 3 but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM5 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study.
11351048|NCT04009577|EG001|Reported Event|Cohort 1A (Core Study): LEM 10|Participants who took ZOL at least 3 but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 and later up titrated to LEM10 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study.
11351049|NCT04009577|EG002|Reported Event|Cohort 1B (Core Study): LEM 5|Participants who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening Period, received LEM5 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study.
11351050|NCT04009577|EG003|Reported Event|Cohort 1B (Core Study): LEM 10|Participants who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening Period, initially received LEM5 and later up titrated to LEM10 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study.
11351051|NCT04009577|EG004|Reported Event|Cohort 2A (Core Study): LEM 5|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM5 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study.
11351052|NCT04009577|EG005|Reported Event|Cohort 2A (Core Study): LEM 10|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 and later up titrated to LEM10 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study.
11351053|NCT04009577|EG006|Reported Event|Cohort 2B (Core Study) : LEM 5|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM10 and later down titrated to LEM5 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study.
11351054|NCT04009577|EG007|Reported Event|Cohort 2B (Core Study): LEM 10|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM10 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study.
11351055|NCT04009577|EG008|Reported Event|Cohort 1A (Extension Phase): LEM 5|Participants who took ZOL at least 3 but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM5 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed Titration Period of Core Study entered Extension Phase and continued to receive LEM5 tablet, orally, once at night for up to 12 weeks in the Extension Phase.
10887850|NCT00503308|FG000|Participant Flow|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2-5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
11351056|NCT04009577|EG009|Reported Event|Cohort 1A (Extension Phase): LEM 10|Participants who took ZOL at least 3 but fewer than 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 and later up titrated to LEM10 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed Titration Period of Core Study entered Extension Phase and continued to receive LEM10 tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11351057|NCT04009577|EG010|Reported Event|Cohort 1B (Extension Phase): LEM 5|Participants who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening Period, received LEM5 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed Titration Period of Core Study entered Extension Phase and continued to receive LEM5 tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11351058|NCT04009577|EG011|Reported Event|Cohort 1B (Extension Phase): LEM 10|Participants who met both criteria for intermittent and frequent ZOL use for 1 week each of the last 2 weeks of the 3-week Screening Period, initially received LEM5 and later up titrated to LEM10 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed Titration Period of Core Study entered Extension Phase and continued to receive LEM10 tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11351059|NCT04009577|EG012|Reported Event|Cohort 2A (Extension Phase): LEM 5|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM5 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed Titration Period of Core Study entered Extension Phase and continued to receive LEM5 tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11351060|NCT04009577|EG013|Reported Event|Cohort 2A (Extension Phase): LEM 10|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM5 and later up titrated to LEM10 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed Titration Period of Core Study entered Extension Phase and continued to receive LEM10 tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11351061|NCT04009577|EG014|Reported Event|Cohort 2B (Extension Phase): LEM 5|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, initially received LEM10 and later down titrated to LEM5 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed Titration Period of Core Study entered Extension Phase and continued to receive initially LEM10 and later down titrated to LEM5 tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11166499|NCT01974687|FG002|Participant Flow|Group A: Uprifosbuvir 150 mg (Cohort 4a)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
11166500|NCT01974687|FG003|Participant Flow|Group A: Uprifosbuvir 300 mg (Cohort 5a)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166501|NCT01974687|FG004|Participant Flow|Group A: Placebo (Cohort 6a)|Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
11166502|NCT01974687|FG005|Participant Flow|Group A: Uprifosbuvir 300 mg (Cohort 6a)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166503|NCT01974687|FG006|Participant Flow|Group B: Uprifosbuvir 10 mg (Cohort 1b)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166504|NCT01974687|FG007|Participant Flow|Group B: Uprifosbuvir 25 mg (Cohort 2b)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11166505|NCT01974687|FG008|Participant Flow|Group B: Uprifosbuvir 50 mg (Cohort 3b)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166506|NCT01974687|FG009|Participant Flow|Group B: Uprifosbuvir 150 mg (Cohort 4b)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166507|NCT01974687|FG010|Participant Flow|Group B: Uprifosbuvir 300 mg (Cohort 5b)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166508|NCT01974687|FG011|Participant Flow|Groups C & D: Uprifosbuvir 50 mg (Capsule)|Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
11166509|NCT01974687|FG012|Participant Flow|Groups C & D: Uprifosbuvir 150 mg (Capsule)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
11166510|NCT01974687|FG013|Participant Flow|Groups C & D: Uprifosbuvir 250 mg (Capsule)|Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
11166511|NCT01974687|FG014|Participant Flow|Groups C & D: Uprifosbuvir 300 mg (Capsule)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166512|NCT01974687|FG015|Participant Flow|Groups C & D: Uprifosbuvir 400 mg (Capsule)|Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
11166513|NCT01974687|FG016|Participant Flow|Groups C & D: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
11166514|NCT01974687|FG017|Participant Flow|Groups C & D: Uprifosbuvir 450 mg (Tablet)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166515|NCT01974687|FG018|Participant Flow|Groups C & D: Placebo (Pooled)|Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
11166516|NCT01974687|FG019|Participant Flow|Group E: Uprifosbuvir 150 mg (Cohort 1e)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166517|NCT01974687|FG020|Participant Flow|Group E: Uprifosbuvir 300 mg (Cohort 2e)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166518|NCT01974687|FG021|Participant Flow|Group E: Uprifosbuvir 450 mg (Cohort 3e)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166519|NCT01974687|FG022|Participant Flow|Group F: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
11166520|NCT01974687|FG023|Participant Flow|Group A: Uprifosbuvir 50 mg (Cohort 3a)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166521|NCT01974687|FG024|Participant Flow|Group A: Placebo (Cohorts 1a-5a - Pooled)|Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
11166522|NCT01974687|OG000|Outcome|Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)|Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
11166523|NCT01974687|OG001|Outcome|Group A: Uprifosbuvir 10 mg (Cohort 1a)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166524|NCT01974687|OG002|Outcome|Group A: Uprifosbuvir 25 mg (Cohort 2a)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11166525|NCT01974687|OG003|Outcome|Group A: Uprifosbuvir 50 mg (Cohort 3a)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166526|NCT01974687|OG004|Outcome|Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
11166527|NCT01974687|OG005|Outcome|Group A: Uprifosbuvir 300 mg (Cohort 5a)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166528|NCT01974687|OG006|Outcome|Group A: Uprifosbuvir 300 mg (Cohort 6a)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166529|NCT01974687|OG007|Outcome|Group A: Placebo (Cohort 6a)|Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
11351062|NCT04009577|EG015|Reported Event|Cohort 2B (Extension Phase): LEM 10|Participants who took ZOL at least 5 nights per week, for the last 2 weeks of the 3-week Screening Period, received LEM10 tablet, orally, once at night for up to 2 weeks in Titration Period of Core Study. Eligible participants who completed Titration Period of Core Study entered Extension Phase and continued to receive LEM10 tablet, orally, once at night for up to 12 weeks in the Extension Phase.
11351063|NCT04007159|BG000|Baseline|Overall Participants|Participants applied a semi-occlusive adhesive patch containing the test products 0.02 mL/cm^2 and 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351064|NCT04007159|FG000|Participant Flow|Overall Participants|Participants applied a semi-occlusive adhesive patch containing the test products 0.02 milliliters per centimeters square (mL/cm^2) and 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 minutes (min), test sites were evaluated as per the International Contact Dermatitis Research Group (ICDRG) scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351065|NCT04007159|OG000|Outcome|Developmental Serum|Participants applied a semi-occlusive adhesive patch containing the developmental serum 0.02 mL/cm^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351066|NCT04007159|OG001|Outcome|Developmental Lotion|Participants applied a semi-occlusive adhesive patch containing the developmental lotion 0.02 mL/cm^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351067|NCT04007159|OG002|Outcome|Developmental Cream|Participants applied a semi-occlusive adhesive patch containing the developmental cream 0.02 mL/cm^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351068|NCT04007159|OG003|Outcome|Negative Control|Participants applied a semi-occlusive adhesive patch containing 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351069|NCT04007159|EG000|Reported Event|Developmental Serum|Participants applied a semi-occlusive adhesive patch containing the developmental serum 0.02 mL/cm^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351070|NCT04007159|EG001|Reported Event|Developmental Lotion|Participants applied a semi-occlusive adhesive patch containing the developmental lotion 0.02 mL/cm^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351071|NCT04007159|EG002|Reported Event|Developmental Cream|Participants applied a semi-occlusive adhesive patch containing the developmental cream 0.02 mL/cm^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11166530|NCT01974687|OG008|Outcome|Group B: Uprifosbuvir 10 mg (Cohort 1b)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166531|NCT01974687|OG009|Outcome|Group B: Uprifosbuvir 25 mg (Cohort 2b)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
10887851|NCT00503308|FG001|Participant Flow|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
11166532|NCT01974687|OG010|Outcome|Group B: Uprifosbuvir 50 mg (Cohort 3b)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166533|NCT01974687|OG011|Outcome|Group B: Uprifosbuvir 150 mg (Cohort 4b)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11229414|NCT02397460|FG007|Participant Flow|Cohort 2: Gefapixant 50 mg→PBO→Gefapixant 50 mg→PBO/CC|Participants with chronic cough in Cohort 2/Sequence B received singles doses of gefapixant 50 mg on Day 1 of Periods 1 and 3 and singles doses of placebo on Day 1 of Periods 2 and 4. (Each treatment period consisted of Day 1 and Day 2.) There was a minimum 48-hour washout period between treatment periods.
11229415|NCT02397460|OG000|Outcome|Placebo/Healthy Males|Healthy males who received single doses of placebo in Periods 1 and 2
11229416|NCT02397460|OG001|Outcome|Placebo/Chronic Cough Males|Males with chronic cough who received single doses of placebo in Periods 1 and 2
11229417|NCT02397460|OG002|Outcome|Placebo/Chronic Cough Females|Females with chronic cough who received single doses of placebo in Periods 1 and 2
11229418|NCT02397460|OG003|Outcome|Gefapixant 50 mg/Healthy Males|Healthy males who received single doses of gefapixant 50 mg in Periods 1 and 2
11229419|NCT02397460|OG004|Outcome|Gefapixant 50 mg/Chronic Cough Males|Males with chronic cough who received single doses of gefapixant 50 mg in Periods 1 and 2
11229420|NCT02397460|OG005|Outcome|Gefapixant 50 mg/Chronic Cough Females|Females with chronic cough who received single doses of gefapixant 50 mg in Periods 1 and 2
11229421|NCT02397460|OG006|Outcome|Gefapixant 300 mg/Healthy Males|Healthy males who received single doses of gefapixant 300 mg in Periods 1 and 2
11229422|NCT02397460|OG007|Outcome|Gefapixant 300 mg/Chronic Cough Males|Males with chronic cough who received single doses of gefapixant 300 mg in Periods 1 and 2
11229423|NCT02397460|OG008|Outcome|Gefapixant 300 mg/Chronic Cough Females|Females with chronic cough who received single doses of gefapixant 300 mg in Periods 1 and 2
11229424|NCT02397460|OG000|Outcome|Placebo/Healthy Males|Healthy males who received single doses of placebo in Periods 3 and 4
11229425|NCT02397460|OG001|Outcome|Placebo/Chronic Cough Males|Chronic cough males who received single doses of placebo in Periods 3 and 4
11229426|NCT02397460|OG002|Outcome|Placebo/Chronic Cough Females|Females with chronic cough who received single doses of placebo in Periods 3 and 4
11229427|NCT02397460|OG003|Outcome|Gefapixant 50 mg/Healthy Males|Healthy males who received single doses of gefapixant 50 mg in Periods 3 and 4
11229428|NCT02397460|OG004|Outcome|Gefapixant 50 mg/Chronic Cough Males|Males with chronic cough who received single doses of gefapixant 50 mg in Periods 3 and 4
11229429|NCT02397460|OG005|Outcome|Gefapixant 50 mg/Chronic Cough Females|Females with chronic cough who received single doses of gefapixant 50 mg in Periods 3 and 4
11229430|NCT02397460|OG006|Outcome|Gefapixant 300 mg/Healthy Males|Healthy males who received single doses of gefapixant 300 mg in Periods 3 and 4
11229431|NCT02397460|OG007|Outcome|Gefapixant 300 mg/Chronic Cough Males|Males with chronic cough who received single doses of gefapixant 300 mg in Periods 3 and 4
11229432|NCT02397460|OG008|Outcome|Gefapixant 300 mg/Chronic Cough Females|Females with chronic cough who received single doses of gefapixant 300 mg in Periods 3 and 4
11229433|NCT02397460|OG000|Outcome|Cohort 1: Gefapixant 300 mg/Healthy|Healthy males and females in Cohort 1 who received single doses of gefapixant 300 mg in Periods 1 and 2 combined
11229434|NCT02397460|OG001|Outcome|Cohort 1: Placebo/Healthy|Healthy males and females in Cohort 1 who received single doses of placebo in Periods 1 and 2 combined
11229435|NCT02397460|OG002|Outcome|Cohort 1: Gefapixant 300 mg/Chronic Cough|Males and females with chronic cough in Cohort 1 who received single doses of gefapixant 300 mg in Periods 1 and 2 combined
11229436|NCT02397460|OG003|Outcome|Cohort 1: Placebo/Chronic Cough|Males and females in Cohort 1 with chronic cough who received single doses of placebo in Periods 1 and 2 combined
11229437|NCT02397460|OG004|Outcome|Cohort 2: Gefapixant 50 mg/Healthy|Healthy males and females who received single doses of gefapixant 50 mg in Periods 1 and 2 combined
11229438|NCT02397460|OG005|Outcome|Cohort 2: Placebo/Healthy|Healthy males and females in Cohort 2 who received single doses of placebo in Periods 1 and 2 combined
11229439|NCT02397460|OG006|Outcome|Cohort 2: Gefapixant 50 mg/Chronic Cough|Males and females with chronic cough in Cohort 2 who received single doses of gefapixant 50 mg in Periods 1 and 2 combined
11229440|NCT02397460|OG007|Outcome|Cohort 2: Placebo/Chronic Cough|Males and females with chronic cough in Cohort 2 who received single doses of placebo in Periods 1 and 2 combined
11229441|NCT02397460|OG003|Outcome|Cohort 1: Placebo/Chronic Cough|Males and females with chronic cough in Cohort 1 who received single doses of placebo in Periods 1 and 2 combined
11229442|NCT02397460|OG004|Outcome|Cohort 2: Gefapixant 50 mg/Healthy|Healthy males and females in Cohort 2 who received single doses of gefapixant 50 mg in Periods 1 and 2 combined
11229443|NCT02397460|OG000|Outcome|Cohort 1: Gefapixant 300 mg/Healthy|Healthy males and females in Cohort 1 who received single doses of gefapixant 300 mg in Periods 3 and 4 combined
11229444|NCT02397460|OG001|Outcome|Cohort 1: Placebo/Healthy|Healthy males and females in Cohort 1 who received single doses of placebo in Periods 3 and 4 combined
11229445|NCT02397460|OG002|Outcome|Cohort 1: Gefapixant 300 mg/Chronic Cough|Males and females with chronic cough in Cohort 1 who received single doses of gefapixant 300 mg in Periods 3 and 4 combined
11229446|NCT02397460|OG003|Outcome|Cohort 1: Placebo/Chronic Cough|Males and females with chronic cough in Cohort 1 who received single doses of placebo in Periods 3 and 4 combined
11229447|NCT02397460|OG004|Outcome|Cohort 2: Gefapixant 50 mg/Healthy|Healthy males and females in Cohort 2 who received single doses of gefapixant 50 mg in Periods 3 and 4 combined
11229448|NCT02397460|OG005|Outcome|Cohort 2: Placebo/Healthy|Healthy males and females in Cohort 2 who received single doses of placebo in Periods 3 and 4 combined
11229449|NCT02397460|OG006|Outcome|Cohort 2: Gefapixant 50 mg/Chronic Cough|Males and females with chronic cough in Cohort 2 who received single doses of gefapixant 50 mg in Periods 3 and 4 combined
11166534|NCT01974687|OG012|Outcome|Group B: Uprifosbuvir 300 mg (Cohort 5b)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166535|NCT01974687|OG013|Outcome|Groups C & D: Uprifosbuvir 50 mg (Capsule)|Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
11166536|NCT01974687|OG014|Outcome|Groups C & D: Uprifosbuvir 150 mg (Capsule)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
11166537|NCT01974687|OG015|Outcome|Groups C & D: Uprifosbuvir 250 mg (Capsule)|Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
11166538|NCT01974687|OG016|Outcome|Groups C & D: Uprifosbuvir 300 mg (Capsule)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166539|NCT01974687|OG017|Outcome|Groups C & D: Uprifosbuvir 400 mg (Capsule)|Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
11166540|NCT01974687|OG018|Outcome|Groups C & D: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
11166541|NCT01974687|OG019|Outcome|Groups C & D: Uprifosbuvir 450 mg (Tablet)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166542|NCT01974687|OG020|Outcome|Groups C & D: Placebo (Pooled)|Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
11166543|NCT01974687|OG021|Outcome|Group E: Uprifosbuvir 150 mg (Cohort 1e)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166544|NCT01974687|OG022|Outcome|Group E: Uprifosbuvir 300 mg (Cohort 2e)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166545|NCT01974687|OG023|Outcome|Group E: Uprifosbuvir 450 mg (Cohort 3e)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166546|NCT01974687|OG024|Outcome|Group F: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
11166547|NCT01974687|OG000|Outcome|Group A: Uprifosbuvir 10 mg (Cohort 1a)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166548|NCT01974687|OG001|Outcome|Group A: Uprifosbuvir 25 mg (Cohort 2a)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11166549|NCT01974687|OG002|Outcome|Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
11166550|NCT01974687|OG003|Outcome|Group A: Uprifosbuvir 300 mg (Cohort 5a)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166551|NCT01974687|OG004|Outcome|Group A: Uprifosbuvir 50 mg (Cohort 3a)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166552|NCT01974687|OG000|Outcome|Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
11166553|NCT01974687|OG000|Outcome|Group A: Uprifosbuvir 300 mg (Cohort 6a)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166554|NCT01974687|OG000|Outcome|Group B: Uprifosbuvir 10 mg (Cohort 1b)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166555|NCT01974687|OG001|Outcome|Group B: Uprifosbuvir 25 mg (Cohort 2b)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11166556|NCT01974687|OG002|Outcome|Group B: Uprifosbuvir 50 mg (Cohort 3b)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166557|NCT01974687|OG003|Outcome|Group B: Uprifosbuvir 150 mg (Cohort 4b)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166558|NCT01974687|OG004|Outcome|Group B: Uprifosbuvir 300 mg (Cohort 5b)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166559|NCT01974687|OG000|Outcome|Groups C & D: Uprifosbuvir 50 mg (Capsule)|Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
11166560|NCT01974687|OG001|Outcome|Groups C & D: Uprifosbuvir 150 mg (Capsule)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
11166561|NCT01974687|OG002|Outcome|Groups C & D: Uprifosbuvir 300 mg (Capsule)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166562|NCT01974687|OG003|Outcome|Groups C & D: Uprifosbuvir 400 mg (Capsule)|Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
11166563|NCT01974687|OG000|Outcome|Group C: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
11166564|NCT01974687|OG001|Outcome|Group C: Uprifosbuvir 450 mg (Tablet)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166565|NCT01974687|OG000|Outcome|Group E: Uprifosbuvir 150 mg (Cohort 1e)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11351072|NCT04007159|EG003|Reported Event|Negative Control|Participants applied a semi-occlusive adhesive patch containing 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351073|NCT04007159|EG004|Reported Event|Overall Participants|Participants applied a semi-occlusive adhesive patch containing the test products 0.02 mL/cm^2 and 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
11351074|NCT04007107|BG000|Baseline|Overall Study|Participants were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
11351075|NCT04007107|FG000|Participant Flow|Sequence A: DV3396 (Right) Then PDS290 (Left)|Participants were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11351076|NCT04007107|FG001|Participant Flow|Sequence B: DV3396 (Left) Then PDS290 (Right)|Participants were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11351077|NCT04007107|FG002|Participant Flow|Sequence C: PDS290 (Right) Then DV3396 (Left)|Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11351078|NCT04007107|FG003|Participant Flow|Sequence D: PDS290 (Left) Then DV3396 (Right)|Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
11351079|NCT04007107|OG000|Outcome|DV3396|Participants were to receive a s.c. injection of DV3396 product (0.25 mg of semaglutide) on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
11351080|NCT04007107|OG001|Outcome|PDS290|Participants were to receive a s.c. injection of PDS290 product (0.25 mg of semaglutide) on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
11351081|NCT04007107|EG000|Reported Event|Overall Study|Participants were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
11351082|NCT04006795|BG000|Baseline|Overall Participants|All participants in 3 week induction phase topically applied 2 semiocclusive patch (0.02 mL/cm^2)on Monday, containing developmental serum,lotion,cream,negative control(NaCl: 0.9 %)at 2 sites on dorsum for 24 hours.Post patch removal (Tuesday) sites cleaned,developmental serum reapplied,1 site irradiated with 2.5 J/cm^2 UVA radiation,then with 0.3 MEDs of UVA+UVB radiation.Duplicate test site not exposed to UVradiation. 24hours post irradiation(Wednesday),sites assessed,duplicate patches applied as on Monday.Irradiation on Thursday similar to Tuesday,assessment post 24 hour on Friday.Participants then entered 2 week rest phase(no product or patch applications) followed by challenge phase where all participants applied 2 semiocclusive patches at 2 naive sites for 24 hours, 1 site irradiated(like induction phase).Assessment done after 24,48,72 hours of irradiation till Day 40.
11351083|NCT04006795|FG000|Participant Flow|Overall Participants|All participants in 3 week induction phase topically applied 2 semiocclusive patch (0.02milliliters per centimeter square[mL/cm^2])on Monday, containing developmental serum,lotion,cream,negative control(Sodium Chloride[NaCl:0.9percent{%}])at 2sites on dorsum for 24hours.Post patch removal(Tuesday)sites cleaned,developmental serum reapplied,1site irradiated with 2.5Joules per centimeters square(J/cm^2)ultraviolet(UV)A radiation,then with 0.3minimal erythemal doses(MEDs)of UVA+UVB radiation.Duplicate test site not exposed to UVradiation.24hours post irradiation(Wednesday),sites assessed,duplicate patches applied as on Monday.Irradiation on Thursday similar to Tuesday,assessment post 24hour on Friday.Participants then entered 2week rest phase(no product or patch applications) followed by challenge phase where all participants applied 2semiocclusive patches at 2naive sites for 24hours,1site irradiated(like induction phase).Assessment done after 24,48,72 hours of irradiation till Day40.
11229450|NCT02397460|OG007|Outcome|Cohort 2: Placebo/Chronic Cough|Males and females with chronic cough in Cohort 2 who received single doses of placebo in Periods 3 and 4 combined
11229451|NCT02397460|OG002|Outcome|Cohort 1: Chronic Cough/Gefapixant 300 mg|Males and females with chronic cough in Cohort 1 who received single doses of gefapixant 300 mg in Periods 3 and 4 combined
11229452|NCT02397460|OG007|Outcome|Cohort 2: Placebo/Chronic Cough|Males and females with chronic cough in Cohort 2 who received placebo in Periods 3 and 4 combined
11229453|NCT02397460|OG000|Outcome|Cohort 1: Gefapixant 300 mg/Chronic Cough|Participants with chronic cough in Cohort 1 who received single doses of gefapixant 300 mg in Periods 1 and 2 combined
11229454|NCT02397460|OG001|Outcome|Cohort 1: Placebo/Chronic Cough|Participants with chronic cough in Cohort 1 who received single doses of placebo in Periods 1 and 2 combined
11229455|NCT02397460|OG002|Outcome|Cohort 2: Gefapixant 50 mg/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of gefapixant 50 mg in Periods 1 and 2 combined
11229456|NCT02397460|OG003|Outcome|Cohort 2: Placebo/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of placebo in Periods 1 and 2 combined
11229457|NCT02397460|OG000|Outcome|Cohort 1: Gefapixant 300 mg/Chronic Cough|Participants with chronic cough in Cohort 1 who received single doses of gefapixant 300 mg in Periods 3 and 4 combined
11229458|NCT02397460|OG001|Outcome|Cohort 1: Placebo/Chronic Cough|Participants with chronic cough in Cohort 1 who received single doses of placebo in Periods 3 and 4 combined
11229459|NCT02397460|OG002|Outcome|Cohort 2: Gefapixant 50 mg/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of gefapixant 50 mg in Periods 3 and 4 combined
11229460|NCT02397460|OG003|Outcome|Cohort 2: Placebo/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of placebo in Periods 3 and 4 combined
11229461|NCT02397460|OG000|Outcome|Cohort 1: Gefapixant 300 mg/Chronic Cough|Participants with chronic cough in Cohort 1 who received gefapixant 300 mg in Periods 1 and 2 combined
11229462|NCT02397460|OG001|Outcome|Cohort 1: Placebo/Chronic Cough|Participants with chronic cough in Cohort 1 who received placebo in Periods 1 and 2 combined
11229463|NCT02397460|OG002|Outcome|Cohort 2: Gefapixant 50 mg/Chronic Cough|Participants with chronic cough in Cohort 2 who received gefapixant 50 mg in Periods 1 and 2 combined
11229464|NCT02397460|OG003|Outcome|Cohort 2: Placebo/Chronic Cough|Participants with chronic cough in Cohort 2 who received placebo in Periods 1 and 2 combined.
11229465|NCT02397460|OG001|Outcome|Cohort 1: Placebo/Chronic Cough|Participants with chronic cough in Cohort 1 who received placebo in Periods 3 and 4 combined
11229466|NCT02397460|OG002|Outcome|Cohort 2: Gefapixant 50 mg/Chronic Cough|Participants with chronic cough in Cohort 2 who received gefapixant 50 mg in Periods 3 and 4 combined
11229467|NCT02397460|OG003|Outcome|Cohort 2: Placebo/Chronic Cough|Participants with chronic cough in Cohort 2 who received placebo in Periods 3 and 4 combined
11229468|NCT02397460|OG003|Outcome|Cohort 2: Placebo/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of placebo in treatment Periods 1 and 2 combined
11229469|NCT02397460|OG000|Outcome|Cohort 1: Gefapixant 300 mg/Healthy|Healthy participants in Cohort 1 who received singles doses of gefapixant 300 mg
11229470|NCT02397460|OG001|Outcome|Cohort 1: Placebo/Healthy|Healthy participants in Cohort 1 who received single doses of placebo
11229471|NCT02397460|OG002|Outcome|Cohort 1: Gefapixant 300 mg/Chronic Cough|Participants with chronic cough in Cohort 1 who received single doses of gefapixant 300 mg
11229472|NCT02397460|OG003|Outcome|Cohort 1: Placebo/Chronic Cough|Participants with chronic cough in Cohort 1 who received single doses of placebo
11229473|NCT02397460|OG004|Outcome|Cohort 2: Gefapixant 50 mg/Healthy|Healthy participants in Cohort 2 who received single doses of gefapixant 50 mg
11229474|NCT02397460|OG005|Outcome|Cohort 2: Placebo/Healthy|Healthy participants in Cohort 2 who received single doses of placebo
11229475|NCT02397460|OG006|Outcome|Cohort 2: Gefapixant 50 mg/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of gefapixant 50 mg
11229476|NCT02397460|OG007|Outcome|Cohort 2: Placebo/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of placebo
11229477|NCT02397460|OG000|Outcome|Cohort 1: Gefapixant 300 mg/Healthy|Healthy participants in Cohort 1 who received single doses of gefapixant 300 mg
11229478|NCT02397460|OG002|Outcome|Cohort 1: Gefapixant 300 mg/Chronic Cough|Participants with chronic cough in Cohort 1 who received singles doses of gefapixant 300 mg
11229479|NCT02397460|EG000|Reported Event|Cohort 1: Gefapixant 300 mg/Healthy|Healthy participants in Cohort 1 who received single doses of gefapixant 300 mg
11229480|NCT02397460|EG001|Reported Event|Cohort 1: Placebo/Healthy|Healthy participants in Cohort 1 who received single doses of placebo
11229481|NCT02397460|EG002|Reported Event|Cohort 1: Gefapixant 300 mg/Chronic Cough|Participants with chronic cough in Cohort 1 who received single doses of gefapixant 300 mg
11229482|NCT02397460|EG003|Reported Event|Cohort 1: Placebo/Chronic Cough|Participants with chronic cough in Cohort 1 who received single doses of placebo
11229483|NCT02397460|EG004|Reported Event|Cohort 2: Gefapixant 50 mg/Healthy|Healthy participants in Cohort 2 who received single doses of gefapixant 50 mg
11229484|NCT02397460|EG005|Reported Event|Cohort 2: Placebo/Healthy|Healthy participants in Cohort 2 who received single doses of placebo
11229485|NCT02397460|EG006|Reported Event|Cohort 2: Gefapixant 50 mg/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of gefapixant 50 mg
11229486|NCT02397460|EG007|Reported Event|Cohort 2: Placebo/Chronic Cough|Participants with chronic cough in Cohort 2 who received single doses of placebo
11229487|NCT02397473|BG000|Baseline|Placebo|"Participants received placebo once a month for 2 months by SC injection.~Participants did not receive any intervention during post treatment follow-up phase."
11229488|NCT02397473|BG001|Baseline|Galcanezumab 300mg|"Participants received Galcanezumab 300mg once a month for two months by SC injection.~Participants did not receive any intervention during post treatment follow-up phase."
11229489|NCT02397473|BG002|Baseline|Total|Total of all reporting groups
11229490|NCT02397473|FG000|Participant Flow|Placebo|"Participants received placebo once a month for 2 months by subcutaneous (SC) injection.~Participants did not receive any intervention during post treatment follow-up phase."
11351084|NCT04006795|OG000|Outcome|Developmental Serum|All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental serum (0.02 mL/cm^2) in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental serum was re-applied and 1 of the 2 sites were irradiated with 2.5 J/cm^2 UV A radiation,then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
11351085|NCT04006795|OG001|Outcome|Developmental Lotion|All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental lotion (0.02mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental lotion was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
11351086|NCT04006795|OG002|Outcome|Developmental Cream|All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental cream (0.02mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental cream was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
11351087|NCT04006795|OG003|Outcome|Negative Control|All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing 0.9 percent normal saline (0.02mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, normal saline was re-applied and 1 of the 2 sites was irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
11351088|NCT04006795|EG000|Reported Event|Developmental Serum|All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental serum (0.02 mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental serum was re-applied and 1 of the 2 sites were irradiated with 2.5 J/cm^2 UV A radiation,then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
11351089|NCT04006795|EG001|Reported Event|Developmental Lotion|All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental lotion (0.02 mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental lotion was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
11351090|NCT04006795|EG002|Reported Event|Developmental Cream|All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental cream (0.02 mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental cream was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40..
11166566|NCT01974687|OG000|Outcome|Group E: Uprifosbuvir 300 mg (Cohort 2e)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11229491|NCT02397473|FG001|Participant Flow|Galcanezumab 300mg|"Participants received Galcanezumab 300mg once a month for two months by subcutaneous (SC) injection.~Participants did not receive any intervention during post treatment follow-up phase."
11229492|NCT02397473|OG000|Outcome|Placebo|"Participants received placebo once a month for two months by SC injection.~Participants did not receive any intervention during post treatment follow-up phase."
11229493|NCT02397473|OG001|Outcome|Galcanezumab 300mg|"Participants received Galcanezumab 300mg once a month for two months by SC injection.~Participants did not receive any intervention during post treatment follow-up phase."
11229494|NCT02397473|OG000|Outcome|Galcanezumab 300mg|"Participants received Galcanezumab 300mg once a month for two months by SC injection.~Participants did not receive any intervention during post treatment follow-up phase."
11229495|NCT02397473|EG000|Reported Event|Placebo - Treatment Phase|Participants received placebo once a month for two months by SC injection.
11229496|NCT02397473|EG001|Reported Event|Galcanezumab 300mg - Treatment Phase|Participants received Galcanezumab 300mg once a month for two months by SC injection.
11229497|NCT02397473|EG002|Reported Event|Placebo - Post Treatment Phase|Participants didn't receive any intervention.
11229498|NCT02397473|EG003|Reported Event|Galcanezumab 300mg - Post Treatment Phase|Participants didn't receive any intervention.
11229499|NCT02397564|BG000|Baseline|Treatment Group|"Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.~Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting"
11229500|NCT02397564|FG000|Participant Flow|Intervention Group|"Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.~Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting"
11229501|NCT02397564|OG000|Outcome|Treatment Group|Subjects receiving treatment for scar
11229502|NCT02397564|OG000|Outcome|Treatment Group|Number of patients that preferred the fractionated laser.
11229503|NCT02397564|EG000|Reported Event|Treatment Group|Those who went laser treatment.
11233917|NCT02431533|EG001|Reported Event|Di-Calcium Phosphate|"Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate~Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate"
11233918|NCT02431559|BG000|Baseline|Phase 1, Dose Level 0a|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W [equivalent to 450 mg Q4W] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
11233919|NCT02431559|BG001|Baseline|Phase 1, Dose Level 0b|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
11233920|NCT02431559|BG002|Baseline|Phase 1, Dose Level +1|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
11233921|NCT02431559|BG003|Baseline|Phase 2|Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
11233922|NCT02431559|BG004|Baseline|Total|Total of all reporting groups
11233923|NCT02431559|FG000|Participant Flow|Phase 1, Dose Level 0a|Subjects received pegylated liposomal doxorubicin (PLD) (40 mg/m^2 intravenously [IV] on Day 1 of every cycle) + durvalumab (3 mg/kg every 2 weeks [Q2W, equivalent to 450 mg every 4 weeks (Q4W)] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m^2 subcutaneous [SC]) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
11233924|NCT02431559|FG001|Participant Flow|Phase 1, Dose Level 0b|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
11233925|NCT02431559|FG002|Participant Flow|Phase 1, Dose Level +1|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
11351091|NCT04006795|EG003|Reported Event|Negative Control|All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing 0.9 percent normal saline (0.02 mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, normal saline was re-applied and 1 of the 2 sites was irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
11351092|NCT04006795|EG004|Reported Event|Overall Participants|All participants in 3 week induction phase topically applied 2 semiocclusive patch (0.02 mL/cm^2)on Monday, containing developmental serum,lotion,cream,negative control(NaCl: 0.9 %)at 2 sites on dorsum for 24 hours.Post patch removal (Tuesday) sites cleaned,developmental serum reapplied,1 site irradiated with 2.5 J/cm^2 UVA radiation,then with 0.3 MEDs of UVA+UVB radiation.Duplicate test site not exposed to UVradiation. 24hours post irradiation(Wednesday),sites assessed,duplicate patches applied as on Monday.Irradiation on Thursday similar to Tuesday,assessment post 24 hour on Friday.Participants then entered 2 week rest phase(no product or patch applications) followed by challenge phase where all participants applied 2 semiocclusive patches at 2 naive sites for 24 hours, 1 site irradiated(like induction phase).Assessment done after 24,48,72 hours of irradiation till Day 40.
11351093|NCT04005885|BG000|Baseline|Overall Study|"Subjects were randomized to wear comfilcon A lens on a daily wear, reusable basis for 1 month, then fitted and wear the somofilcon A daily disposable test lens and stenfilcon A daily disposable test lens each for 1 week of daily wear.~comfilcon A: Contact Lens~somofilcon A: daily disposable contact lens~stenfilcon A: daily disposable contact lens"
11351094|NCT04005885|FG000|Participant Flow|Somofilcon A, Then Stenfilcon A Contact Lens|"All subjects fitted with the comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear the somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.~comfilcon A : contact lens~somofilcon A: daily disposable contact lens~stenfilcon A: daily disposable contact lens"
11351095|NCT04005885|FG001|Participant Flow|Stenfilcon A, Then Somofilcon A Contact Lens|"All subjects fitted with comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.~comfilcon A: Contact Lens~somofilcon A: daily disposable contact lens~stenfilcon A: daily disposable contact lens"
11351096|NCT04005885|OG000|Outcome|Comfilcon A|"Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.~comfilcon A: Contact Lens"
11351097|NCT04005885|OG000|Outcome|Somofilcon A Contact Lens|"Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear.~somofilcon A: daily disposable contact lens"
11351098|NCT04005885|OG001|Outcome|Stenfilcon A Contact Lens|"Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.~stenfilcon A: daily disposable contact lens"
11351099|NCT04005885|OG000|Outcome|Comfilcon A Contact Lens|"Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.~comfilcon A: Contact Lens"
11351100|NCT04005885|OG001|Outcome|Somofilcon A Contact Lens|"Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear.~somofilcon A: daily disposable contact lens"
11351101|NCT04005885|OG002|Outcome|Stenfilcon A Contact Lens|"Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.~stenfilcon A: daily disposable contact lens"
11351102|NCT04005885|EG000|Reported Event|Comfilcon A Contact Lens|"All participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.~comfilcon A: Contact Lens"
11351103|NCT04005885|EG001|Reported Event|Somofilcon A Contact Lens|"Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear.~somofilcon A: daily disposable contact lens"
11351104|NCT04005885|EG002|Reported Event|Stenfilcon A Contact Lens|"Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.~stenfilcon A: daily disposable contact lens"
11351105|NCT04000815|BG000|Baseline|Reproductive Age Women|"The healthy women between 18-40 years old.~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351106|NCT04000815|BG001|Baseline|Perimenopausal Women|"The healthy women between 40-49 years old.~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351107|NCT04000815|BG002|Baseline|Postmenopausal Women|"The healthy women that has been in to menopause more than a year~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351108|NCT04000815|BG003|Baseline|Total|Total of all reporting groups
11351109|NCT04000815|FG000|Participant Flow|Reproductive Age Women|"The healthy women between 18-40 years old.~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351110|NCT04000815|FG001|Participant Flow|Perimenopausal Women|"The healthy women between 40-49 years old.~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351111|NCT04000815|FG002|Participant Flow|Postmenopausal Women|"The healthy women that has been in to menopause more than a year~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351112|NCT04000815|OG000|Outcome|Reproductive Age Women|"The healthy women between 18-40 years old.~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351113|NCT04000815|OG001|Outcome|Perimenopausal Women|"The healthy women between 40-49 years old.~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351114|NCT04000815|OG002|Outcome|Postmenopausal Women|"The healthy women that has been in to menopause more than a year~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351115|NCT04000815|EG000|Reported Event|Reproductive Age Women|"The healthy women between 18-40 years old.~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351116|NCT04000815|EG001|Reported Event|Perimenopausal Women|"The healthy women between 40-49 years old.~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351117|NCT04000815|EG002|Reported Event|Postmenopausal Women|"The healthy women that has been in to menopause more than a year~C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method"
11351118|NCT03999944|BG000|Baseline|All Study Participants|All study participants
11351119|NCT03999944|FG000|Participant Flow|Sequence 1 (FRESCA Flow Generator Then FRESCA Airbox Flow Generator)|Subject first used FRESCA Flow Generator during in-lab sleep night, then used the FRESCA Airbox Flow Generator during in-lab sleep night between 0 - 14 days later.
11351120|NCT03999944|FG001|Participant Flow|Sequence 2 (FRESCA Airbox Flow Generator, Then FRESCA Flow Generator)|Subject first used FRESCA Airbox Flow Generator during in-lab sleep night, then used the FRESCA Flow Generator during in-lab sleep night between 0 - 14 days later.
11351121|NCT03999944|OG000|Outcome|FRESCA Flow Generator|Participants used the FRESCA Flow Generator on either the first or second sleep night.
11351122|NCT03999944|OG001|Outcome|FRESCA Airbox Flow Generator|Participants used the FRESCA Airbox Flow Generator on either the first or second sleep night.
11351123|NCT03999944|OG001|Outcome|FRESCA Airbox Flow Generator|Participants used the FRESCA Flow Generator on either the first or second sleep night.
11351124|NCT03999944|EG000|Reported Event|FRESCA Flow Generator|"Existing FRESCA device programmed to deliver fixed pressure.~positive airway pressure system: Positive Airway Pressure System"
11351125|NCT03999944|EG001|Reported Event|FRESCA Airbox Flow Generator|"Investigational FRESCA device programmed to deliver auto-adjusting pressure~positive airway pressure system: Positive Airway Pressure System"
11351126|NCT03995680|BG000|Baseline|Chewable Tablet of Mebendazole|"A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm.~Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet."
11351127|NCT03995680|BG001|Baseline|Swallowable Tablet of Mebendazole|"A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm.~Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet."
11351128|NCT03995680|BG002|Baseline|Total|Total of all reporting groups
11351129|NCT03995680|FG000|Participant Flow|Chewable Tablet of Mebendazole|"A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm.~Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet."
11351130|NCT03995680|FG001|Participant Flow|Swallowable Tablet of Mebendazole|"A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm.~Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet."
11351131|NCT03995680|OG000|Outcome|Chewable Tablet of Mebendazole|"A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm.~Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet."
11351132|NCT03995680|OG001|Outcome|Swallowable Tablet of Mebendazole|"A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm.~Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet."
11351133|NCT03995680|EG000|Reported Event|Chewable Tablet of Mebendazole|"A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm.~Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet."
11351134|NCT03995680|EG001|Reported Event|Swallowable Tablet of Mebendazole|"A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm.~Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet."
11351135|NCT04006366|BG000|Baseline|Intervention|"To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).~Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients."
10887852|NCT00503308|OG000|Outcome|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2-5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
11229504|NCT02397655|BG000|Baseline|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
11229505|NCT02397655|FG000|Participant Flow|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
11229506|NCT02397655|OG000|Outcome|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
11229507|NCT02397655|EG000|Reported Event|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
11229508|NCT02397694|BG000|Baseline|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
11229509|NCT02397694|BG001|Baseline|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
11229510|NCT02397694|BG002|Baseline|Total|Total of all reporting groups
11229511|NCT02397694|FG000|Participant Flow|BIC + F/TAF|Bictegravir (BIC) (75 mg) + emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) + dolutegravir (DTG) placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
11229512|NCT02397694|FG001|Participant Flow|DTG + F/TAF|DTG (50 mg) + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
11229513|NCT02397694|OG000|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
11229514|NCT02397694|OG001|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
11229515|NCT02397694|OG000|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take the study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
11229516|NCT02397694|OG001|Outcome|DTG + F/TAF|After participants completed their blinded treatment with DTG 50 mg + F/TAF 200/25 mg FDC + BIC placebo, they were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25).
11229517|NCT02397694|EG000|Reported Event|BIC + F/TAF (Double-Blind Randomized)|Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to BIC + F/TAF. Participants received BIC (75 mg) + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks.
11229518|NCT02397694|EG001|Reported Event|DTG + F/TAF (Double Blind Randomized):|Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to DTG + FTC/TAF. Participants received DTG (50 mg) + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily.
11229519|NCT02397694|EG002|Reported Event|BIC + F/TAF to B/F/TAF (Open-Label Phase)|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Extension Phase from the BIC + F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet.
11229520|NCT02397694|EG003|Reported Event|DTG + F/TAF to B/F/TAF (Open-Label Phase)|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Extension Phase from the DTG + F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet.
11229521|NCT02397707|BG000|Baseline|Normal Hepatic Function|Participants with normal hepatic function received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229522|NCT02397707|BG001|Baseline|Moderate Hepatic Impairment (MHI)|Participants with moderate hepatic impairment received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229523|NCT02397707|BG002|Baseline|Severe Hepatic Impairment (SHI)|Participants with severe hepatic impairment received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229524|NCT02397707|BG003|Baseline|Total|Total of all reporting groups
11229525|NCT02397707|FG000|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229526|NCT02397707|FG001|Participant Flow|Moderate Hepatic Impairment (MHI)|Participants with moderate hepatic impairment received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229527|NCT02397707|FG002|Participant Flow|Severe Hepatic Impairment (SHI)|Participants with severe hepatic impairment received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229528|NCT02397707|OG000|Outcome|Moderate Hepatic Impairment (MHI)|Participants with moderate hepatic impairment received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229529|NCT02397707|OG001|Outcome|Severe Hepatic Impairment (SHI)|Participants with severe hepatic impairment received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229530|NCT02397707|OG002|Outcome|Normal Hepatic Function (Matched Control for MHI)|Normal Hepatic Function (matched control for MHI) included participants that served as controls for participants with MHI.
11229531|NCT02397707|OG003|Outcome|Normal Hepatic Function (Matched Controls for SHI)|Normal hepatic function (matched controls for SHI) included participants that served as controls for participants with SHI.
11229532|NCT02397707|EG000|Reported Event|Normal Hepatic Function|Participants with normal hepatic function received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229533|NCT02397707|EG001|Reported Event|Moderate Hepatic Impairment (MHI)|Participants with moderate hepatic impairment received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229534|NCT02397707|EG002|Reported Event|Severe Hepatic Impairment (SHI)|Participants with severe hepatic impairment received single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229535|NCT02397785|BG000|Baseline|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
11229536|NCT02397785|BG001|Baseline|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
11229537|NCT02397785|BG002|Baseline|Total|Total of all reporting groups
11229538|NCT02397785|FG000|Participant Flow|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
11229539|NCT02397785|FG001|Participant Flow|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
11229540|NCT02397785|OG000|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
11229541|NCT02397785|OG001|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
11233926|NCT02431559|FG003|Participant Flow|Phase 2|Subjects received the maximum tolerated dose (MTD) determined in Phase 1, comprising PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
11351136|NCT04006366|FG000|Participant Flow|Intervention|"To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).~Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients."
11351137|NCT04006366|OG000|Outcome|Intervention|"To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).~Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients."
11351138|NCT04006366|EG000|Reported Event|Intervention|"To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).~Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients."
11351139|NCT04006145|BG000|Baseline|Elobixibat|"Elobixibat 5 mg once daily~Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT)."
11351140|NCT04006145|BG001|Baseline|Placebo|"Placebo~Placebo oral tablet: Placebo identical in appearance to active drug"
11351141|NCT04006145|BG002|Baseline|Total|Total of all reporting groups
11351142|NCT04006145|FG000|Participant Flow|Elobixibat|"Elobixibat 5 mg once daily~Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT)."
11351143|NCT04006145|FG001|Participant Flow|Placebo|"Placebo~Placebo oral tablet: Placebo identical in appearance to active drug"
11351144|NCT04006145|OG000|Outcome|Elobixibat|"Elobixibat 5 mg once daily~Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT)."
11351145|NCT04006145|OG001|Outcome|Placebo|"Placebo~Placebo oral tablet: Placebo identical in appearance to active drug"
11351146|NCT04006145|EG000|Reported Event|Elobixibat|"Elobixibat 5 mg once daily~Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT)."
11351147|NCT04006145|EG001|Reported Event|Placebo|"Placebo~Placebo oral tablet: Placebo identical in appearance to active drug"
11351148|NCT04005755|BG000|Baseline|Maxigesic® IV|"Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.~Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion"
11351149|NCT04005755|FG000|Participant Flow|Maxigesic® IV|"Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.~Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion"
11351150|NCT04005755|OG000|Outcome|Maxigesic® IV|"Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.~Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion"
11351151|NCT04005755|EG000|Reported Event|Maxigesic® IV|"Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.~Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion"
11351152|NCT04005586|BG000|Baseline|Light Delivery Device (LDD)|"Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.~Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments"
11351153|NCT04005586|FG000|Participant Flow|Light Delivery Device (LDD)|"Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.~Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments"
11351154|NCT04005586|OG000|Outcome|Light Delivery Device (LDD)|"Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.~Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments"
11351155|NCT04005586|EG000|Reported Event|Light Delivery Device (LDD)|"Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.~Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments"
11351156|NCT04005404|BG000|Baseline|Intertrochanteric Femoral Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351157|NCT04005404|BG001|Baseline|Neck Femur Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351158|NCT04005404|BG002|Baseline|Subtrochanteric Femoral Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351159|NCT04005404|BG003|Baseline|Total|Total of all reporting groups
11351160|NCT04005404|FG000|Participant Flow|Intertrochanteric Femoral Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11229542|NCT02397785|EG000|Reported Event|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
11229543|NCT02397785|EG001|Reported Event|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
11229544|NCT02397837|BG000|Baseline|Pramipexole|"Pramipexole, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.~Pramipexole: Up to 4.5mg, PO, (by mouth) per day of the 12-week study."
11229545|NCT02397837|BG001|Baseline|Placebo|"Placebo, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.~Placebo: placebo match study drug"
11229546|NCT02397837|BG002|Baseline|Total|Total of all reporting groups
11229547|NCT02397837|FG000|Participant Flow|Pramipexole|"Pramipexole, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.~Pramipexole: Up to 4.5mg, PO, (by mouth) per day of the 12-week study."
11229548|NCT02397837|FG001|Participant Flow|Placebo|"Placebo, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.~Placebo: placebo match study drug"
11229549|NCT02397837|OG000|Outcome|Pramipexole|"Pramipexole, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.~Pramipexole: Up to 4.5mg, PO, (by mouth) per day of the 12-week study."
11229550|NCT02397837|OG001|Outcome|Placebo|"Placebo, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.~Placebo: placebo match study drug"
11229551|NCT02397837|EG000|Reported Event|Pramipexole|"Pramipexole, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.~Pramipexole: Up to 4.5mg, PO, (by mouth) per day of the 12-week study."
11229552|NCT02397837|EG001|Reported Event|Placebo|"Placebo, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.~Placebo: placebo match study drug"
11229553|NCT02397889|BG000|Baseline|Experimental Ketamine Group|0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
11229554|NCT02397889|BG001|Baseline|Active Control Midazolam Group|0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
11229555|NCT02397889|BG002|Baseline|Total|Total of all reporting groups
11229556|NCT02397889|FG000|Participant Flow|Experimental Ketamine Group|0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
10887853|NCT00503308|OG001|Outcome|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
11229557|NCT02397889|FG001|Participant Flow|Active Control Midazolam Group|0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
11229558|NCT02397889|OG000|Outcome|Experimental Ketamine Group|0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
11229559|NCT02397889|OG001|Outcome|Active Control Midazolam Group|0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
11229560|NCT02397889|EG000|Reported Event|Experimental Ketamine Group|0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
11229561|NCT02397889|EG001|Reported Event|Active Control Midazolam Group|0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
11229562|NCT02397915|BG000|Baseline|FF 110 µg /MF 200 µg or MF 200 µg /FF 110 µg|All participants received treatments in one of two treatment sequences, Sequence 1: two sprays of FF (total of 110 µg) in each nostril (total 4 sprays) in Period 1 and two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) in Period 2; Sequence 2: FF (110 µg) followed by MF (total of 200 µg) and MF (total of 200 µg) followed by FF (110 µg) in Period 2. Two study treatments were administered 30 minutes (+/-5) apart by a third party administrator using a metered nasal spray.
11229563|NCT02397915|FG000|Participant Flow|Period 1: FF 110 µg|Participants received two sprays of FF (total dose of 110 micrograms [µg]) in each nostril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
11229564|NCT02397915|FG001|Participant Flow|Period 1: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
11229565|NCT02397915|FG002|Participant Flow|Period 2: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays).
11229566|NCT02397915|FG003|Participant Flow|Period 2: FF 110 µg|Participants received FF (total dose of 110 µg) in each nostril (total 4 sprays).
11229567|NCT02397915|OG000|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
11229568|NCT02397915|OG001|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
11229569|NCT02397915|OG000|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
11229570|NCT02397915|OG001|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
11229571|NCT02397915|EG000|Reported Event|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
11229572|NCT02397915|EG001|Reported Event|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
11229573|NCT02397954|BG000|Baseline|Zimura + Anti-VEGF|Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
11229574|NCT02397954|FG000|Participant Flow|Zimura + Anti-VEGF|Zimura 1mg/eye intravitreal injection + Anti-vascular endothelial growth factor (VEGF) (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
11229575|NCT02397954|OG000|Outcome|Zimura + Anti-VEGF|Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
11229576|NCT02397954|EG000|Reported Event|Zimura + Anti-VEGF|Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
11229577|NCT02398188|BG000|Baseline|LIPO-202|"Experimental arm~LIPO-202"
11229578|NCT02398188|BG001|Baseline|Placebo|"Placebo comparator~Placebo"
11229579|NCT02398188|BG002|Baseline|Total|Total of all reporting groups
11229580|NCT02398188|FG000|Participant Flow|LIPO-202|"Experimental arm~LIPO-202"
11229581|NCT02398188|FG001|Participant Flow|Placebo|"Placebo comparator~Placebo"
11229582|NCT02398188|OG000|Outcome|LIPO-202|"Experimental arm~LIPO-202"
11229583|NCT02398188|OG001|Outcome|Placebo|"Placebo comparator~Placebo"
11229584|NCT02398188|EG000|Reported Event|LIPO-202|"Experimental arm~LIPO-202"
11229585|NCT02398188|EG001|Reported Event|Placebo|"Placebo comparator~Placebo"
11229586|NCT02398227|BG000|Baseline|HOPE|"Cognitive Behavioral Treatment Program for PTSD~HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women"
11229587|NCT02398227|BG001|Baseline|Present Centered Therapy (PCT)|"Present Centered Therapy for PTSD~PCT: Present Centered Therapy for PTSD"
11229588|NCT02398227|BG002|Baseline|Total|Total of all reporting groups
11229589|NCT02398227|FG000|Participant Flow|HOPE|"Cognitive Behavioral Treatment Program for PTSD~HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women"
11229590|NCT02398227|FG001|Participant Flow|Present Centered Therapy (PCT)|"Present Centered Therapy for PTSD~PCT: Present Centered Therapy for PTSD"
11229591|NCT02398227|OG000|Outcome|HOPE|"Cognitive Behavioral Treatment Program for PTSD~HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women"
11229592|NCT02398227|OG001|Outcome|Present Centered Therapy (PCT)|"Present Centered Therapy for PTSD~PCT: Present Centered Therapy for PTSD"
11229593|NCT02398227|EG000|Reported Event|HOPE|"Cognitive Behavioral Treatment Program for PTSD~HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women"
11229594|NCT02398227|EG001|Reported Event|Present Centered Therapy (PCT)|"Present Centered Therapy for PTSD~PCT: Present Centered Therapy for PTSD"
11229595|NCT02398409|BG000|Baseline|ANSWERS-VA|"8 week telephone intervention with nurse case manager using Acquiring New Skills While Enhancing Remaining Strengths (ANSWERS)~ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: Randomized trial to evaluate the efficacy of the telephone intervention Acquiring New Skills While Enhancing Remaining Strengthsin informal caregivers of Veterans with stroke and TBI."
11229596|NCT02398409|BG001|Baseline|Control|"8 week telephone usual care with education with nurse case manager~Control: 8 week telephone usual care with education with nurse case manager"
11229597|NCT02398409|BG002|Baseline|Total|Total of all reporting groups
11229598|NCT02398409|FG000|Participant Flow|ANSWERS-VA|"8 week telephone intervention with nurse case manager using Acquiring New Skills While Enhancing Remaining Strengths (ANSWERS)~ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: Randomized trial to evaluate the efficacy of the telephone intervention Acquiring New Skills While Enhancing Remaining Strengthsin informal caregivers of Veterans with stroke and Traumatic Brain Injury (TBI)."
11229599|NCT02398409|FG001|Participant Flow|Control|"8 week telephone usual care with education with nurse case manager~Control: 8 week telephone usual care with education with nurse case manager"
11229600|NCT02398409|OG000|Outcome|ANSWERS-VA|"8 week telephone intervention with nurse case manager using Acquiring New Skills While Enhancing Remaining Strengths (ANSWERS)~ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: Randomized trial to evaluate the efficacy of the telephone intervention Acquiring New Skills While Enhancing Remaining Strengthsin informal caregivers of Veterans with stroke and TBI."
11229601|NCT02398409|OG001|Outcome|Control|"8 week telephone usual care with education with nurse case manager~Control: 8 week telephone usual care with education with nurse case manager"
11229602|NCT02398409|EG000|Reported Event|ANSWERS-VA|"8 week telephone intervention with nurse case manager using Acquiring New Skills While Enhancing Remaining Strengths (ANSWERS)~ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: Randomized trial to evaluate the efficacy of the telephone intervention Acquiring New Skills While Enhancing Remaining Strengthsin informal caregivers of Veterans with stroke and TBI."
11229603|NCT02398409|EG001|Reported Event|Control|"8 week telephone usual care with education with nurse case manager~Control: 8 week telephone usual care with education with nurse case manager"
11229604|NCT02399085|BG000|Baseline|Treatment (MOR00208, Lenalidomide)|"MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.~Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.~MOR00208: 12 mg/kg~Lenalidomide: 25 mg"
11229605|NCT02399085|FG000|Participant Flow|Treatment (MOR00208, Lenalidomide)|"MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.~Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.~MOR00208: 12 mg/kg~Lenalidomide: 25 mg"
11229606|NCT02399085|OG000|Outcome|Treatment (MOR00208, Lenalidomide)|"MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.~Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.~MOR00208: 12 mg/kg~Lenalidomide: 25 mg"
11229607|NCT02399085|EG000|Reported Event|Treatment (MOR00208, Lenalidomide)|"MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.~Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.~MOR00208: 12 mg/kg~Lenalidomide: 25 mg"
11229608|NCT02399163|BG000|Baseline|Overall Participants|All randomized participants were evaluated for baseline characteristics
11229609|NCT02399163|FG000|Participant Flow|Overall Study|"In this cross-over study, participants were randomized to receive each of following treatments:~Fluoride dentifrice/Fluoride rinse~Placebo dentifrice/Fluoride rinse~Fluoride dentifrice/No rinse~Placebo dentifrice/No rinse"
11229610|NCT02399163|OG000|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
11229611|NCT02399163|OG001|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
11229612|NCT02399163|OG000|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
11229613|NCT02399163|OG002|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
11229614|NCT02399163|OG003|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
11229615|NCT02399163|OG003|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
11229616|NCT02399163|EG000|Reported Event|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
11229617|NCT02399163|EG001|Reported Event|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
11229618|NCT02399163|EG002|Reported Event|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
11229619|NCT02399163|EG003|Reported Event|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
11229620|NCT02399228|BG000|Baseline|0.25% EISO Mouth Rinse|"A mouth rinse containing 0.25% East Indian sandalwood oil (EISO), a candidate botanical drug substance. The rinse will be used three times a day for up to ten weeks. The material will not be ingested but used to swish, gargle and spit.~0.25% EISO mouth rinse: A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis"
11229621|NCT02399228|FG000|Participant Flow|0.25% EISO Mouth Rinse|"A mouth rinse containing 0.25% East Indian sandalwood oil (EISO), a candidate botanical drug substance. The rinse will be used three times a day for up to ten weeks. The material will not be ingested but used to swish, gargle and spit.~0.25% EISO mouth rinse: A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis"
11229622|NCT02399228|OG000|Outcome|0.25% EISO Mouth Rinse|"A mouth rinse containing 0.25% East Indian sandalwood oil (EISO), a candidate botanical drug substance. The rinse will be used three times a day for up to ten weeks. The material will not be ingested but used to swish, gargle and spit.~0.25% EISO mouth rinse: A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis"
11229623|NCT02399228|EG000|Reported Event|0.25% EISO Mouth Rinse|"A mouth rinse containing 0.25% East Indian sandalwood oil (EISO), a candidate botanical drug substance. The rinse will be used three times a day for up to ten weeks. The material will not be ingested but used to swish, gargle and spit.~0.25% EISO mouth rinse: A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis"
11229624|NCT02399254|BG000|Baseline|Pulmonary Rehabilitation|COPD patients following pulmonary rehabilitation
11229625|NCT02399254|FG000|Participant Flow|Pulmonary Rehabilitation|COPD patients following pulmonary rehabilitation
11229626|NCT02399254|OG000|Outcome|Pulmonary Rehabilitation|Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation
11229627|NCT02399254|OG000|Outcome|Pulmonary Rehabilitation|COPD patients following pulmonary rehabilitation
11229628|NCT02399254|EG000|Reported Event|Pulmonary Rehabilitation|COPD patients following pulmonary rehabilitation
11229629|NCT02399345|BG000|Baseline|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
11229630|NCT02399345|FG000|Participant Flow|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
11229631|NCT02399345|OG000|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
11229632|NCT02399345|EG000|Reported Event|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
11229633|NCT02399475|BG000|Baseline|Levothyroxine First|"Participants will start on the thyroid hormone Levothyroxine prior to crossing over to Liothyronine~Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L~Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L~Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment)."
11229634|NCT02399475|BG001|Baseline|Liothyronine First|"Participants will start on the thyroid hormone Liothyronine prior to crossing over to Levothyroxine~Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L~Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L~Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment)."
11229635|NCT02399475|BG002|Baseline|Total|Total of all reporting groups
11229636|NCT02399475|FG000|Participant Flow|Levothyroxine First|"Participants will start on the thyroid hormone Levothyroxine prior to crossing over to Liothyronine~Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L~Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L~Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment)."
11229637|NCT02399475|FG001|Participant Flow|Liothyronine First|"Participants will start on the thyroid hormone Liothyronine prior to crossing over to Levothyroxine~Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L~Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L~Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment)."
11229638|NCT02399475|OG000|Outcome|Levothyroxine|While taking levothyroxine
11229639|NCT02399475|OG001|Outcome|Liothyronine|While taking liothyronine
11229640|NCT02399475|EG000|Reported Event|Levothyroxine|While taking levothyroxine
11229641|NCT02399475|EG001|Reported Event|Liothyronine|While taking liothyronine
11229642|NCT02399917|BG000|Baseline|Phase 1b Lead-in Cohort 1|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 1.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229643|NCT02399917|BG001|Baseline|Phase 1b Lead-in Cohort 2|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 3.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229644|NCT02399917|BG002|Baseline|Phase 2|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 3.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229645|NCT02399917|BG003|Baseline|Total|Total of all reporting groups
11229646|NCT02399917|FG000|Participant Flow|Phase 1b Lead-in Cohort 1|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 1.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229647|NCT02399917|FG001|Participant Flow|Phase 1b Lead-in Cohort 2|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 3.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229648|NCT02399917|FG002|Participant Flow|Phase 2|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 3.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229649|NCT02399917|OG000|Outcome|All Phase 1 Participants|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 1.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229650|NCT02399917|OG000|Outcome|Phase 1b Lead-in Cohort 1|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 1.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229651|NCT02399917|OG001|Outcome|Phase 1b Lead-in Cohort 2|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 3.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229652|NCT02399917|OG002|Outcome|Phase 2|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 3.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229653|NCT02399917|EG000|Reported Event|Phase 1b Lead-in Cohort 1|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 1.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229654|NCT02399917|EG001|Reported Event|Phase 1b Lead-in Cohort 2|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 3.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229655|NCT02399917|EG002|Reported Event|Phase 2|"Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~5-Azacitidine 75mg/m^2 Lirilumab 3.0 mg/kg~Azacitidine: Given SC or IV~Lirilumab: Given IV"
11229656|NCT02400073|BG000|Baseline|AutoSet for Her PAP Device|"Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA~AutoSet for Her: 3 months nightly usage of the AutoSet for Her device"
11229657|NCT02400073|FG000|Participant Flow|AutoSet for Her PAP Device|"Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA~AutoSet for Her: 3 months nightly usage of the AutoSet for Her device"
11229658|NCT02400073|OG000|Outcome|AutoSet for Her PAP Device|"Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA~AutoSet for Her: 3 months nightly usage of the AutoSet for Her device"
11229659|NCT02400073|EG000|Reported Event|AutoSet for Her PAP Device|"Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA~AutoSet for Her: 3 months nightly usage of the AutoSet for Her device"
11229660|NCT02400307|BG000|Baseline|Severe Renal Impairment|Participants with severe renal impairment (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
11229661|NCT02400307|BG001|Baseline|Normal Renal Function|Matched healthy control participants with normal renal function (CrCl ≥ 90 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
11229662|NCT02400307|BG002|Baseline|Total|Total of all reporting groups
11229663|NCT02400307|FG000|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
11229664|NCT02400307|FG001|Participant Flow|Normal Renal Function|Matched healthy control participants with normal renal function (CrCl ≥ 90 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
11229665|NCT02400307|OG000|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
11229666|NCT02400307|OG001|Outcome|Normal Renal Function|Matched healthy control participants with normal renal function (CrCl ≥ 90 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
11229667|NCT02400307|EG000|Reported Event|Severe Renal Impairment|Participants with severe renal impairment (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
11229668|NCT02400307|EG001|Reported Event|Normal Renal Function|Matched healthy control participants with normal renal function (CrCl ≥ 90 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
11229669|NCT02400333|BG000|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
11229670|NCT02400333|BG001|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
11229671|NCT02400333|BG002|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
11229672|NCT02400333|BG003|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
11229673|NCT02400333|BG004|Baseline|Total|Total of all reporting groups
11229674|NCT02400333|FG000|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
11229675|NCT02400333|FG001|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
11229676|NCT02400333|FG002|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
11229677|NCT02400333|FG003|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
11229678|NCT02400333|OG000|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
11351161|NCT04005404|FG001|Participant Flow|Neck Femur Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351162|NCT04005404|FG002|Participant Flow|Subtrochanteric Femoral Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351163|NCT04005404|OG000|Outcome|Intertrochanteric Femoral Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351164|NCT04005404|OG001|Outcome|Neck Femur Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351165|NCT04005404|OG002|Outcome|Subtrochanteric Femoral Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351166|NCT04005404|EG000|Reported Event|Intertrochanteric Femoral Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351167|NCT04005404|EG001|Reported Event|Neck Femur Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351168|NCT04005404|EG002|Reported Event|Subtrochanteric Femoral Fractures|"Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%~Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%"
11351169|NCT03993288|BG000|Baseline|Ferrum Lek|Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
11351170|NCT03993288|BG001|Baseline|MALTOFER|Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
11351171|NCT03993288|BG002|Baseline|Total|Total of all reporting groups
11351172|NCT03993288|FG000|Participant Flow|Ferrum Lek|Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
11351173|NCT03993288|FG001|Participant Flow|MALTOFER|Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
11351174|NCT03993288|OG000|Outcome|Ferrum Lek|Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
11351175|NCT03993288|OG001|Outcome|MALTOFER|Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
11351176|NCT03993288|EG000|Reported Event|Ferrum Lek|Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
11351177|NCT03993288|EG001|Reported Event|MALTOFER|Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
11351178|NCT03990298|BG000|Baseline|Awake Endoscopic Examination|Subjects who underwent upper airway stimulation (UAS) implantation were recruited for a prospective single-arm cohort study during UAS device activation. Functional thresholds were recorded for all settings. Awake nasopharyngoscopy was performed to examine the retropalatal (RP) and retroglossal (RG) regions at rest and during activation at five different electrode configurations at their functional thresholds. Electrode configurations included: +-+, ---, -o-, o-o, and -+-. Cross-sectional measurements were made by two blinded reviewers and reported as percent change in airway size.
11351179|NCT03990298|FG000|Participant Flow|Awake Endoscopic Exam|"Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages.~Awake endoscopy: Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation."
11351180|NCT03990298|OG000|Outcome|Awake Endoscopic Exam|"Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages.~Awake endoscopy: Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation."
11351181|NCT03990298|EG000|Reported Event|Awake Endoscopic Examination|"Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages.~Awake endoscopy: Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation."
11351182|NCT03988647|BG000|Baseline|Pembrolizumab + Palliative Radiation Therapy|"Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy~Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks~Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions)."
11351183|NCT03988647|FG000|Participant Flow|Pembrolizumab + Palliative Radiation Therapy|"Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy~Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks~Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions)."
11166567|NCT01974687|OG001|Outcome|Group E: Uprifosbuvir 450 mg (Cohort 3e)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166568|NCT01974687|OG000|Outcome|Group F: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
11166569|NCT01974687|OG004|Outcome|Groups C & D: Placebo (Pooled)|Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
11166570|NCT01974687|OG005|Outcome|Groups C & D: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
11166571|NCT01974687|OG006|Outcome|Groups C & D: Uprifosbuvir 450 mg (Tablet)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166572|NCT01974687|OG000|Outcome|Group B: Uprifosbuvir 150 mg (Cohort 4b)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166573|NCT01974687|OG001|Outcome|Group C: Uprifosbuvir 300 mg (Capsule)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166574|NCT01974687|OG002|Outcome|Group E: Uprifosbuvir 450 mg|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166575|NCT01974687|EG000|Reported Event|Group A: Placebo (Cohort 1a - Cohort 5a - Pooled)|Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
11166576|NCT01974687|EG001|Reported Event|Group A: Uprifosbuvir 10 mg (Cohort 1a)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166577|NCT01974687|EG002|Reported Event|Group A: Uprifosbuvir 25 mg (Cohort 2a)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11166578|NCT01974687|EG003|Reported Event|Group A: Uprifosbuvir 50 mg (Cohort 3a)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166579|NCT01974687|EG004|Reported Event|Group A: Uprifosbuvir 150 mg (Cohort 4a)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
11166580|NCT01974687|EG005|Reported Event|Group A: Uprifosbuvir 300 mg (Cohort 5a)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166581|NCT01974687|EG006|Reported Event|Group A: Placebo (Cohort 6a)|Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
11166582|NCT01974687|EG007|Reported Event|Group A: Uprifosbuvir 300 mg (Cohort 6a)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166583|NCT01974687|EG008|Reported Event|Group B: Uprifosbuvir 10 mg (Cohort 1b)|Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
11166584|NCT01974687|EG009|Reported Event|Group B: Uprifosbuvir 25 mg (Cohort 2b)|Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
11166585|NCT01974687|EG010|Reported Event|Group B: Uprifosbuvir 50 mg (Cohort 3b)|Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
11166586|NCT01974687|EG011|Reported Event|Group B: Uprifosbuvir 150 mg (Cohort 4b)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166587|NCT01974687|EG012|Reported Event|Group B: Uprifosbuvir 300 mg (Cohort 5b)|Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
11166588|NCT01974687|EG013|Reported Event|Groups C & D: Uprifosbuvir 50 mg (Capsule)|Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
11166589|NCT01974687|EG014|Reported Event|Groups C & D: Uprifosbuvir 150 mg (Capsule)|Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
11166590|NCT01974687|EG015|Reported Event|Groups C & D: Uprifosbuvir 250 mg (Capsule)|Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
11166591|NCT01974687|EG016|Reported Event|Groups C & D: Uprifosbuvir 300 mg (Capsule)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166592|NCT01974687|EG017|Reported Event|Groups C & D: Uprifosbuvir 400 mg (Capsule)|Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
11166593|NCT01974687|EG018|Reported Event|Groups C & D: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
11166594|NCT01974687|EG019|Reported Event|Groups C & D: Uprifosbuvir 450 mg (Tablet)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11166595|NCT01974687|EG020|Reported Event|Groups C & D: Placebo (Pooled)|Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
11166596|NCT01974687|EG021|Reported Event|Group E: Uprifosbuvir 150 mg (Cohort 1e)|Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
11166597|NCT01974687|EG022|Reported Event|Group E: Uprifosbuvir 300 mg (Cohort 2e)|Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
11166598|NCT01974687|EG023|Reported Event|Group E: Uprifosbuvir 450 mg (Cohort 3e)|Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
11351184|NCT03988647|OG000|Outcome|Pembrolizumab + Palliative Radiation Therapy|"Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy~Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks~Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions)."
11351185|NCT03988647|EG000|Reported Event|Pembrolizumab + Palliative Radiation Therapy|"Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy~Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks~Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions)."
11351186|NCT03979872|BG000|Baseline|Arm 1: Skin Cancer Education Only|"Participants will be randomized to receive education only.~Skin Cancer Education: [See arm/group descriptions]"
11351187|NCT03979872|BG001|Baseline|Arm 2: Skin Cancer Education + UV Photo|"Participants randomized to receive education + UV photo will have a UV light photo taken of their face to show UV damage in the skin that is invisible to the naked eye in addition to receiving skin cancer education.~Skin Cancer Education: [See arm/group descriptions]~UV Photo: [See arm/group descriptions]"
11351188|NCT03979872|BG002|Baseline|Arm 3: Skin Cancer Education + MC1R Testing|"Participants randomized to receive education + genetic testing will be asked to provide a saliva sample for MC1R testing in addition to receiving skin cancer education.~MC1R Genetic Testing: [See arm/group descriptions]~Skin Cancer Education: [See arm/group descriptions]"
11351189|NCT03979872|BG003|Baseline|Arm 4: Skin Cancer Education + UV Photo + MC1R Testing|"Participants randomized to receive education + UV photo + genetic testing will have a UV light photo taken of their face, Submit a saliva sample for MC1R testing, and receive skin cancer education.~MC1R Genetic Testing: [See arm/group descriptions]~Skin Cancer Education: [See arm/group descriptions]~UV Photo: [See arm/group descriptions]"
11351190|NCT03979872|BG004|Baseline|Total|Total of all reporting groups
11351191|NCT03979872|FG000|Participant Flow|Arm 1: Skin Cancer Education Only|"Participants will be randomized to receive education only.~Skin Cancer Education: [See arm/group descriptions]"
11351192|NCT03979872|FG001|Participant Flow|Arm 2: Skin Cancer Education + UV Photo|"Participants randomized to receive education + UV photo will have a UV light photo taken of their face to show UV damage in the skin that is invisible to the naked eye in addition to receiving skin cancer education.~Skin Cancer Education: [See arm/group descriptions]~UV Photo: [See arm/group descriptions]"
11351193|NCT03979872|FG002|Participant Flow|Arm 3: Skin Cancer Education + MC1R Testing|"Participants randomized to receive education + genetic testing will be asked to provide a saliva sample for MC1R testing in addition to receiving skin cancer education.~MC1R Genetic Testing: [See arm/group descriptions]~Skin Cancer Education: [See arm/group descriptions]"
11351194|NCT03979872|FG003|Participant Flow|Arm 4: Skin Cancer Education + UV Photo + MC1R Testing|"Participants randomized to receive education + UV photo + genetic testing will have a UV light photo taken of their face, Submit a saliva sample for MC1R testing, and receive skin cancer education.~MC1R Genetic Testing: [See arm/group descriptions]~Skin Cancer Education: [See arm/group descriptions]~UV Photo: [See arm/group descriptions]"
11351195|NCT03979872|OG000|Outcome|Arm 1: Skin Cancer Education Only|"Participants will be randomized to receive education only.~Skin Cancer Education: [See arm/group descriptions]"
11351196|NCT03979872|OG001|Outcome|Arm 2: Skin Cancer Education + UV Photo|"Participants randomized to receive education + UV photo will have a UV light photo taken of their face to show UV damage in the skin that is invisible to the naked eye in addition to receiving skin cancer education.~Skin Cancer Education: [See arm/group descriptions]~UV Photo: [See arm/group descriptions]"
11351197|NCT03979872|OG002|Outcome|Arm 3: Skin Cancer Education + MC1R Testing|"Participants randomized to receive education + genetic testing will be asked to provide a saliva sample for MC1R testing in addition to receiving skin cancer education.~MC1R Genetic Testing: [See arm/group descriptions]~Skin Cancer Education: [See arm/group descriptions]"
11351198|NCT03979872|OG003|Outcome|Arm 4: Skin Cancer Education + UV Photo + MC1R Testing|"Participants randomized to receive education + UV photo + genetic testing will have a UV light photo taken of their face, Submit a saliva sample for MC1R testing, and receive skin cancer education.~MC1R Genetic Testing: [See arm/group descriptions]~Skin Cancer Education: [See arm/group descriptions]~UV Photo: [See arm/group descriptions]"
11351199|NCT03979872|EG000|Reported Event|Arm 1: Skin Cancer Education Only|"Participants will be randomized to receive education only.~Skin Cancer Education: [See arm/group descriptions]"
11351200|NCT03979872|EG001|Reported Event|Arm 2: Skin Cancer Education + UV Photo|"Participants randomized to receive education + UV photo will have a UV light photo taken of their face to show UV damage in the skin that is invisible to the naked eye in addition to receiving skin cancer education.~Skin Cancer Education: [See arm/group descriptions]~UV Photo: [See arm/group descriptions]"
11351201|NCT03979872|EG002|Reported Event|Arm 3: Skin Cancer Education + MC1R Testing|"Participants randomized to receive education + genetic testing will be asked to provide a saliva sample for MC1R testing in addition to receiving skin cancer education.~MC1R Genetic Testing: [See arm/group descriptions]~Skin Cancer Education: [See arm/group descriptions]"
11351202|NCT03979872|EG003|Reported Event|Arm 4: Skin Cancer Education + UV Photo + MC1R Testing|"Participants randomized to receive education + UV photo + genetic testing will have a UV light photo taken of their face, Submit a saliva sample for MC1R testing, and receive skin cancer education.~MC1R Genetic Testing: [See arm/group descriptions]~Skin Cancer Education: [See arm/group descriptions]~UV Photo: [See arm/group descriptions]"
11351203|NCT03978832|BG000|Baseline|Oral Risperidone Followed by PERSERIS|"All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.~PERSERIS: PERSERIS is an extended-release SC injectable suspension administered once-monthly~Risperidone: Oral risperidone"
11351204|NCT03978832|FG000|Participant Flow|Oral Risperidone Followed by PERSERIS|"All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.~PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly~Risperidone: Oral risperidone"
11166599|NCT01974687|EG024|Reported Event|Group F: Uprifosbuvir 300 mg (Tablet)|Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
11166600|NCT01974700|BG000|Baseline|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
11166601|NCT01974700|BG001|Baseline|No Anti-epileptic Treatment|
11166602|NCT01974700|BG002|Baseline|Total|Total of all reporting groups
11166603|NCT01974700|FG000|Participant Flow|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
11166604|NCT01974700|FG001|Participant Flow|No Anti-epileptic Treatment|
11166605|NCT01974700|OG000|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
11166606|NCT01974700|OG001|Outcome|No Anti-epileptic Treatment|
11166607|NCT01974700|EG000|Reported Event|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
11166608|NCT01974700|EG001|Reported Event|No Anti-epileptic Treatment|
11166609|NCT01974752|BG000|Baseline|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
11166610|NCT01974752|BG001|Baseline|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
11166611|NCT01974752|BG002|Baseline|Total|Total of all reporting groups
11166612|NCT01974752|FG000|Participant Flow|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
11166613|NCT01974752|FG001|Participant Flow|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
11166614|NCT01974752|OG000|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
11166615|NCT01974752|OG001|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
11166616|NCT01974752|EG000|Reported Event|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
11166617|NCT01974752|EG001|Reported Event|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
11166618|NCT01974817|BG000|Baseline|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.~13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
11166619|NCT01974817|FG000|Participant Flow|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.~13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
11166620|NCT01974817|OG000|Outcome|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
11166621|NCT01974817|EG000|Reported Event|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
11166622|NCT01974895|BG000|Baseline|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
11166623|NCT01974895|BG001|Baseline|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
11166624|NCT01974895|BG002|Baseline|Total|Total of all reporting groups
11166625|NCT01974895|FG000|Participant Flow|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
11166626|NCT01974895|FG001|Participant Flow|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
11166627|NCT01974895|OG000|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
11166628|NCT01974895|OG001|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
11166629|NCT01974895|EG000|Reported Event|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
11166630|NCT01974895|EG001|Reported Event|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
11166631|NCT01975090|BG000|Baseline|SENTRY IVC Filter Group|Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation
11166632|NCT01975090|FG000|Participant Flow|SENTRY IVC Filter|Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
11166633|NCT01975090|OG000|Outcome|SENTRY IVC Filter|"The SENTRY IVC Bioconvertible Filter~SENTRY IVC Filter: The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval."
11166634|NCT01975090|OG000|Outcome|Filter Tilting|Core Lab reviewed imaging data at 6 month follow-up
11166635|NCT01975090|OG001|Outcome|Filter Migration|Core Lab reviewed imaging data at 6 month follow-up
11166636|NCT01975090|OG002|Outcome|Filter Embolization|Core Lab reviewed imaging data at 6 month follow-up
11166637|NCT01975090|OG003|Outcome|Filter Fracture|Core Lab reviewed imaging data at 6 month follow-up
11166638|NCT01975090|OG004|Outcome|Filter Perforation|Core Lab reviewed imaging data at 6 month follow-up
11166639|NCT01975090|OG005|Outcome|Symptomatic Complications|Symptomatic Complications is the composite of Symptomatic Caval Thrombosis and Other Symptomatic Complications Requiring Invasive Intervention and filter-related death at 6 months
11166640|NCT01975090|EG000|Reported Event|SENTRY IVC Filter|Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
11229679|NCT02400333|OG001|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
11229680|NCT02400333|OG002|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a nasogastric tube (NG) tube into the stomach (total of 200 mL of water).
11229681|NCT02400333|OG003|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
11229682|NCT02400333|OG002|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
11229683|NCT02400333|EG000|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
11229684|NCT02400333|EG001|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
11229685|NCT02400333|EG002|Reported Event|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
11229686|NCT02400333|EG003|Reported Event|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
11229687|NCT02400346|BG000|Baseline|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.~Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.~Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
11229688|NCT02400346|FG000|Participant Flow|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.~Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.~Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
11229689|NCT02400346|OG000|Outcome|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.~Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.~Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
11229690|NCT02400346|EG000|Reported Event|Brex + ADT|
11229691|NCT02400437|BG000|Baseline|Ixazomib, Dexamethasone, Rituximab|"- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity~Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.~Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase~Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase~Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase~Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.~Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.~Rituximab: Doses given on Day 1 of induction and maintenance cycles."
11229692|NCT02400437|FG000|Participant Flow|Ixazomib, Dexamethasone, Rituximab|"- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity~Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.~Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase~Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase~Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase~Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.~Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.~Rituximab: Doses given on Day 1 of induction and maintenance cycles."
11229693|NCT02400437|OG000|Outcome|Ixazomib, Dexamethasone, Rituximab|"- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity~Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.~Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase~Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase~Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase~Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.~Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.~Rituximab: Doses given on Day 1 of induction and maintenance cycles."
11229694|NCT02400437|OG000|Outcome|MYD88 Mutated, CXCR4 Wild-type|Participants who were MYD88 mutated and did not have the CXCR4 mutation
11229695|NCT02400437|OG001|Outcome|MYD88 Mutated, CXCR4 Mutated|Participants with both the MYD88 mutation and a CXCR4 mutation
11229696|NCT02400437|EG000|Reported Event|Ixazomib, Dexamethasone, Rituximab|"- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity~Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.~Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase~Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase~Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase~Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.~Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.~Rituximab: Doses given on Day 1 of induction and maintenance cycles."
11229697|NCT02400463|BG000|Baseline|Ruxolitinib|Ruxolitinib 15 mg by mouth twice daily. For patients unable to ingest tablets, ruxolitinib suspended in water may be administered through a nasogastric (NG) or percutaneous endoscopy gastrostomy (PEG) tube.
11229698|NCT02400463|FG000|Participant Flow|Ruxolitinib|Ruxolitinib 15 mg by mouth twice daily. For patients unable to ingest tablets, ruxolitinib suspended in water may be administered through a nasogastric (NG) or percutaneous endoscopy gastrostomy (PEG) tube.
11229699|NCT02400463|OG000|Outcome|Ruxolitinib|Ruxolitinib 15 mg by mouth twice daily. For patients unable to ingest tablets, ruxolitinib suspended in water may be administered through a nasogastric (NG) or percutaneous endoscopy gastrostomy (PEG) tube.
11229700|NCT02400463|EG000|Reported Event|Ruxolitinib|Ruxolitinib 15 mg by mouth twice daily. For patients unable to ingest tablets, ruxolitinib suspended in water may be administered through a nasogastric (NG) or percutaneous endoscopy gastrostomy (PEG) tube.
11229701|NCT02400580|BG000|Baseline|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
11229702|NCT02400580|BG001|Baseline|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
11229703|NCT02400580|BG002|Baseline|Total|Total of all reporting groups
11229704|NCT02400580|FG000|Participant Flow|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
11229705|NCT02400580|FG001|Participant Flow|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
11229706|NCT02400580|OG000|Outcome|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
11229707|NCT02400580|OG001|Outcome|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
11229708|NCT02400580|EG000|Reported Event|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
11229709|NCT02400580|EG001|Reported Event|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
11229710|NCT02400710|BG000|Baseline|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
11229711|NCT02400710|BG001|Baseline|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
11229712|NCT02400710|BG002|Baseline|Total|Total of all reporting groups
11229713|NCT02400710|FG000|Participant Flow|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
11229714|NCT02400710|FG001|Participant Flow|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
11229715|NCT02400710|OG000|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
11229716|NCT02400710|OG001|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
11229717|NCT02400710|EG000|Reported Event|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
11229718|NCT02400710|EG001|Reported Event|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
11229719|NCT02400749|BG000|Baseline|Apremilast|"Patients will receive apremilast until Week 32.~Apremilast: Apremilast tablets provided to sites in blister cards.~Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid."
11229720|NCT02400749|BG001|Baseline|Placebo Followed by Apremilast|"Patients will receive Placebo until Week 16 and then receive apremilast until Week 32~Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.~Patients will be provided a titration blister pack containing placebo at the Day 0 visit and apremilast 10 mg, 20 mg and 30 mg at the Week 16 visit (refer to section 6.1). Following the 6 day titration period (for Day 0 and Week 16), patients will receive blister packs containing apremilast 30 mg bid or placebo bid."
11229721|NCT02400749|BG002|Baseline|Total|Total of all reporting groups
11229722|NCT02400749|FG000|Participant Flow|Apremilast|"Patients will receive apremilast until Week 32.~Apremilast: Apremilast tablets provided to sites in blister cards.~Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid."
11229723|NCT02400749|FG001|Participant Flow|Placebo Followed by Apremilast|"Patients will receive Placebo until Week 16 and then receive apremilast until Week 32~Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.~Patients will be provided a titration blister pack containing placebo at the Day 0 visit and apremilast 10 mg, 20 mg and 30 mg at the Week 16 visit (refer to section 6.1). Following the 6 day titration period (for Day 0 and Week 16), patients will receive blister packs containing apremilast 30 mg bid or placebo bid."
11229724|NCT02400749|OG000|Outcome|Apremilast|"Patients will receive apremilast until Week 32.~Apremilast: Apremilast tablets provided to sites in blister cards.~Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid."
11351205|NCT03978832|OG000|Outcome|Oral Risperidone Followed by PERSERIS|"All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.~PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly~Risperidone: Oral risperidone"
11351206|NCT03978832|EG000|Reported Event|Oral Risperidone Followed by PERSERIS|"All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.~PERSERIS: PERSERIS is an extended-release SC injectable suspension administered once-monthly~Risperidone: Oral risperidone~Outcome measures and adverse events were not reported by intervention, but by number of participants who experienced the adverse event. Based on narrative, it was possible to determine the timing of the serious adverse event. By nature of the adverse event, any injection site reported adverse events or outcome data occurred in participants who had received PERSERIS"
11351207|NCT04005391|BG000|Baseline|Postpartum Contraceptives Offered to Intervention Clusters|"Women will have postpartum contraceptive options (condoms vive amor, birth control pills segura plus, injectable cyclofem, contraceptive implant jadelle) offered to them at their routine forty day postpartum visit after routine care is provided, first.~Offer of Participant's Choice of Contraception Method: Women will be offered a range of contraceptive options (condoms, contraceptive pills, medroxyprogesterone acetate injection, levonorgestrel implant) to choose from; they can decline to start a contraceptive method"
11351208|NCT04005391|BG001|Baseline|Routine Care Offered to Control Clusters|Women will receive routine postpartum care
11351209|NCT04005391|BG002|Baseline|Total|Total of all reporting groups
11351210|NCT04005391|FG000|Participant Flow|Postpartum Contraceptives Offered to Intervention Clusters|Participants were offered postpartum contraceptives (condoms, pills, injection, implant)
11351211|NCT04005391|FG001|Participant Flow|Routine Care Offered to Control Clusters|Participants received routine counseling on postpartum contraception but did not have access to drugs and devices
11351212|NCT04005391|OG000|Outcome|Postpartum Contraceptives Offered to Intervention Clusters|offered pills, condoms, injectable, implant
11351213|NCT04005391|OG001|Outcome|Routine Care Offered to Control Clusters|given contraceptive counseling
11351214|NCT04005391|OG000|Outcome|Postpartum Contraceptives Offered to Intervention Clusters|patients opted for pills, condoms, injectable, or implant
11351215|NCT04005391|OG001|Outcome|Routine Care Offered to Control Clusters|patients opted for a contraceptive method
11351216|NCT04005391|OG000|Outcome|Postpartum Contraceptives Offered to Intervention Clusters|Participants were offered postpartum contraceptives (condoms, pills, injection, implant)
11351217|NCT04005391|OG001|Outcome|Routine Care Offered to Control Clusters|Participants received routine counseling on postpartum contraception but did not have access to drugs and devices
11351218|NCT04005391|EG000|Reported Event|Postpartum Contraceptives Offered to Intervention Clusters|pills, condoms, injectable, implant offerred
11351219|NCT04005391|EG001|Reported Event|Routine Care Offered to Control Clusters|contraceptive counseling given
11351220|NCT04004481|BG000|Baseline|Adult Patients Undergoing Major Open Abdominal Surgery|"Observational study. In the patients undergoing major open abdominal surgery for cancer tramadol will be used for postoperative analgesia. In the postoperative period parent compound and metabolites of tramadol will be measured. Postoperative analgesia and adverse effects will be registered and compared between CYP2D6 phenotypes observed.~Postoperative analgesia using tramadol: Tramadol 100 mg will be given to the patients in the postoperative period."
11351221|NCT04004481|FG000|Participant Flow|Adult Patients Undergoing Major Open Abdominal Surgery|"Observational study. In the patients undergoing major open abdominal surgery tramadol will be used for postoperative analgesia. In the postoperative period parent compound and metabolites of tramadol will be measured. Postoperative analgesia and adverse effects will be registered and compared between CYP2D6 phenotypes observed and in regards to systemic inflammation and preoperative cholinesterase activity.~Postoperative analgesia using tramadol: Tramadol 100 mg will be given to the patients in the postoperative period."
11351222|NCT04004481|OG000|Outcome|Tramadol Concentration|Median of tramadol concentration in 6 measurements point in postoperative 24 hours
11351223|NCT04004481|OG001|Outcome|ODT Concentration in Poor Metabolizers (PM)|Median ODT concentration in 6 measurements point in postoperative 24 hours in PM
11351224|NCT04004481|OG002|Outcome|ODT Concentration in Intermediate Metabolizers (IM)|Median ODT concentration in 6 measurements point in postoperative 24 hours in IM
11351225|NCT04004481|OG003|Outcome|ODT Concentration in Extensive Metabolizers (EM)|Median ODT concentration in 6 measurements point in postoperative 24 hours in EM
11351226|NCT04004481|OG004|Outcome|ODT Concentration in Ultrafast Metabolizers (UM)|Median ODT concentration in 6 measurements point in postoperative 24 hours in UM
11351227|NCT04004481|OG005|Outcome|NDT Concentration in Poor Metabolizers (PM)|Median NDT concentration in 6 measurements point in postoperative 24 hours in PM
11351228|NCT04004481|OG006|Outcome|NDT Concentration in Intermediate Metabolizers (IM)|Median NDT concentration in 6 measurements point in postoperative 24 hours in IM
11351229|NCT04004481|OG007|Outcome|NDT Concentration in Extensive Metabolizers (EM)|Median NDT concentration in 6 measurements point in postoperative 24 hours in EM
11351230|NCT04004481|OG008|Outcome|NDT Concentration in Ultrafast Metabolizers (UM)|Median NDT concentration in 6 measurements point in postoperative 24 hours in UM
11351231|NCT04004481|OG000|Outcome|Median NRS Score Before Tramadol Administration|NRS score value in awake patients before tramadol administration in 5 measurement point
11351232|NCT04004481|OG001|Outcome|Median NRS Score After Tramadol Administration|NRS score value in awake patients after tramadol administration in 5 measurement point
11351233|NCT04004481|OG000|Outcome|Median CPOT Score Before Tramadol Administration|CPOT score value in awake patients before tramadol administration in 5 measurement point
11351234|NCT04004481|OG001|Outcome|Median CPOT Score After Tramadol Administration|CPOT score value in awake patients after tramadol administration in 5 measurement point
11166641|NCT01975220|BG000|Baseline|High Dose, Fasted|"1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
11166642|NCT01975220|BG001|Baseline|High Dose, Fed|"1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
11166643|NCT01975220|BG002|Baseline|Low Dose, Fasted|"2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
11166644|NCT01975220|BG003|Baseline|Total|Total of all reporting groups
11166645|NCT01975220|FG000|Participant Flow|High Dose, Fasted: 1 FDC Tablet First, Then 3 Single Tablets|"1 fixed dose combination (FDC) tablet first, then 3 single tablets under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin extended release (XR), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
11166646|NCT01975220|FG001|Participant Flow|High Dose, Fasted: 3 Single Tablets First, Then 1 FDC Tablet|"3 single tablets first, then 1 fixed dose combination (FDC) tablet under fasted conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
11166647|NCT01975220|FG002|Participant Flow|High Dose, Fed: 1 FDC Tablet First, Then 3 Single Tablets|"1 fixed dose combination (FDC) tablet first, then 3 single tablets under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
11166648|NCT01975220|FG003|Participant Flow|High Dose, Fed: 3 Single Tablets First, Then 1 FDC Tablet|"3 single tablets first, then 1 fixed dose combination (FDC) tablet under fed conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
11166649|NCT01975220|FG004|Participant Flow|Low Dose, Fasted: 2 FDC Tablets First, Then 4 Single Tablets|"2 fixed low dose combination (FDC) tablets first, then 4 single tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
11166650|NCT01975220|FG005|Participant Flow|Low Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets|"4 single tablets first, then 2 fixed low dose combination (FDC) tablets under fasted conditions:~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets;~12.5 mg Empagliflozin/750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets"
11166651|NCT01975220|OG000|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
11166652|NCT01975220|OG001|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
11166653|NCT01975220|OG002|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
11166654|NCT01975220|OG003|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
11166655|NCT01975220|OG004|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
11166656|NCT01975220|OG005|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
11166657|NCT01975220|OG005|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablets Empagliflozin / 3 x 500 mg tablets Metformin XR
11166658|NCT01975220|EG000|Reported Event|High Dose, Fasted: 1 FDC Tablet|"1 fixed dose combination (FDC) tablet under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR, FDC tablet"
11166659|NCT01975220|EG001|Reported Event|High Dose, Fasted: 3 Single Tablets|"3 single tablets under fasted conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
11166660|NCT01975220|EG002|Reported Event|High Dose, Fed: 1 FDC Tablet|"1 fixed dose combination (FDC) tablet under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
11166661|NCT01975220|EG003|Reported Event|High Dose, Fed: 3 Single Tablets|"3 single tablets under fed conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
11166662|NCT01975220|EG004|Reported Event|Low Dose, Fasted: 2 FDC Tablets|"2 fixed dose combination (FDC) tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets"
11166663|NCT01975220|EG005|Reported Event|Low Dose, Fasted: 4 Single Tablets|"4 single tablets under fed conditions:~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
11174121|NCT02019758|EG001|Reported Event|Active Fluticasone MDI|"Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.~Fluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)~Placebo slurry: Slurry of sucralose - 4 mL twice daily"
11351235|NCT04004481|OG000|Outcome|PONV in EM|We monitored the incidence of PONV with respect to metabolic phenotype.
11351236|NCT04004481|OG001|Outcome|PONV in IM|We monitored the incidence of PONV with respect to metabolic phenotype.
11089375|NCT01523587|EG000|Reported Event|Afatinib|Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
11089376|NCT01523587|EG001|Reported Event|Erlotinib|Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
11089377|NCT01523613|BG000|Baseline|ChemFil Rock Restoration (R-single)|Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration)
11089378|NCT01523613|BG001|Baseline|Fuji IX Restoration (F-single)|Dental restoration made of Fuji IX GP Extra, a high-viscous glassionomer restorative used as posterior dental filling material (using Cavity Conditioner and GC-Coat Plus).
11089379|NCT01523613|BG002|Baseline|Paired Restorations (1R and 1F)|"While this is not truly a separate arm for outcome analysis, this arm represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restorative and 1 Fuji IX GP restorative."
11089380|NCT01523613|BG003|Baseline|Total|Total of all reporting groups
11089381|NCT01523613|FG000|Participant Flow|ChemFil Rock Restoration (R)|Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration)
11089382|NCT01523613|FG001|Participant Flow|Fuji IX Restoration (F)|Dental restoration made of Fuji IX GP Extra, a high-viscous glassionomer restorative used as posterior dental filling material (using Cavity Conditioner and GC-Coat Plus).
11089383|NCT01523613|FG002|Participant Flow|Paired Restorations (Rock + Fuji)|"While this is not truly a separate arm for outcome analysis, this arm represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restorative and 1 Fuji IX GP restorative."
11089384|NCT01523613|OG000|Outcome|ChemFil Rock Restoration (R)|Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration)
11089385|NCT01523613|OG001|Outcome|Fuji IX Restoration (F)|Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus
11089386|NCT01523613|OG000|Outcome|Rock-restored Tooth (R-tooth)|Tooth restored with a ChemFil Rock filling.
11089387|NCT01523613|OG001|Outcome|Fuji-restored Tooth (F-tooth)|Tooth restored with a Fuji IX GP Extra filling.
11089388|NCT01523613|EG000|Reported Event|Rock-restored Tooth (R-tooth)|Tooth restored with a ChemFil Rock filling.
11089389|NCT01523613|EG001|Reported Event|Fuji-restored (F-tooth)|Tooth restored with a Fuji IX GP Extra filling.
11089390|NCT01523704|BG000|Baseline|Home Monitoring Group|"Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up.~BIOTRONIK Home Monitoring System: Home Monitoring system transfers implantable device's data to the main server via internet."
11089391|NCT01523704|BG001|Baseline|Control|"Patients assigned to Control Group (HM + Conventional In-office follow-up - Control group) will have HM programmed ON. In addition to HM, these patients will visit the hospital for device interrogation at 3, 9, 15, 21 and 27 month follow-ups.~BIOTRONIK Home Monitoring System with In-office Follow-up"
11089392|NCT01523704|BG002|Baseline|Total|Total of all reporting groups
11089393|NCT01523704|FG000|Participant Flow|Home Monitoring Group|"Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up.~BIOTRONIK Home Monitoring System: Home Monitoring system transfers implantable device's data to the main server via internet."
11089394|NCT01523704|FG001|Participant Flow|Control|"Patients assigned to Control Group (HM + Conventional In-office follow-up - Control group) will have HM programmed ON. In addition to HM, these patients will visit the hospital for device interrogation at 3, 9, 15, 21 and 27 month follow-ups.~BIOTRONIK Home Monitoring System with In-office Follow-up"
11089395|NCT01523704|OG000|Outcome|Home Monitoring Group|"Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up.~BIOTRONIK Home Monitoring System: Home Monitoring system transfers implantable device's data to the main server via internet."
11089396|NCT01523704|OG001|Outcome|Control|"Patients assigned to Control Group (HM + Conventional In-office follow-up - Control group) will have HM programmed ON. In addition to HM, these patients will visit the hospital for device interrogation at 3, 9, 15, 21 and 27 month follow-ups.~BIOTRONIK Home Monitoring System with In-office Follow-up"
11089397|NCT01523704|OG000|Outcome|Home Monitoring(HM)|"Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up.~BIOTRONIK Home Monitoring System: Home Monitoring system transfers implantable device's data to the main server via internet."
11089398|NCT01523704|EG000|Reported Event|Home Monitoring Group|"Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up.~BIOTRONIK Home Monitoring System: Home Monitoring system transfers implantable device's data to the main server via internet."
11351237|NCT04004481|OG000|Outcome|Number of Patients With Postoperative Respiratory Depression|We examined the occurrence of tramadol-induced respiratory depression in the first 24 hours
11351238|NCT04004481|OG000|Outcome|Low Plasma Cholinesterase Activity|Preoperative plasma cholinesterase activity < 4244 U/L
11351239|NCT04004481|OG001|Outcome|Normal Plasma Cholinesterase Activity|Preoperative plasma cholinesterase activity > 4244 U/L
11351240|NCT04004481|EG000|Reported Event|PONV in EM|We monitored the incidence of PONV with respect to metabolic phenotype.
11351241|NCT04004481|EG001|Reported Event|PONV in IM|We monitored the incidence of PONV with respect to metabolic phenotype.
11351242|NCT04004260|BG000|Baseline|Experimental Group|"The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11351243|NCT04004260|BG001|Baseline|Weekly check-in Control Group|"The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11351244|NCT04004260|BG002|Baseline|Total|Total of all reporting groups
11351245|NCT04004260|FG000|Participant Flow|Experimental Group|"The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11351246|NCT04004260|FG001|Participant Flow|Weekly check-in Control Group|"The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11351247|NCT04004260|OG000|Outcome|Experimental Group|"The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11351248|NCT04004260|OG001|Outcome|Weekly check-in Control Group|"The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11351249|NCT04004260|EG000|Reported Event|Experimental Group|"The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11351250|NCT04004260|EG001|Reported Event|Weekly check-in Control Group|"The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention.~Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned."
11351251|NCT03997851|BG000|Baseline|Topical Acetaminophen and Vehicle Gel|"Each participant will receive topical gel treatments applied for 30 minutes to 4 separate 4 x 4 cm predefined skin areas on the ventral forearms twice at 2 separate study visits.~The 4 treatments are:~5% acetaminophen gel 2.5% acetaminophen gel~1% acetaminophen gel Vehicle gel~Acetaminophen: Topical acetaminophen gel"
11351252|NCT03997851|FG000|Participant Flow|Topical Acetaminophen and Vehicle Gel|"Each participant will receive topical gel treatments applied for 30 minutes to 4 separate 4 x 4 cm predefined skin areas on the ventral forearms twice at 2 separate study visits.~The 4 treatments are:~5% acetaminophen gel 2.5% acetaminophen gel~1% acetaminophen gel Vehicle gel~Acetaminophen: Topical acetaminophen gel"
11166664|NCT01975246|BG000|Baseline|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
11166665|NCT01975246|BG001|Baseline|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
11166666|NCT01975246|BG002|Baseline|Total|Total of all reporting groups
11166667|NCT01975246|FG000|Participant Flow|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
11166668|NCT01975246|FG001|Participant Flow|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
11351253|NCT03997851|OG000|Outcome|Topical 5% Acetaminophen Gel|"Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.~Acetaminophen: Topical acetaminophen gel"
11351254|NCT03997851|OG001|Outcome|Topical 2.5% Acetaminophen Gel|"Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.~Acetaminophen: Topical acetaminophen gel"
11351255|NCT03997851|OG002|Outcome|Topical 1% Acetaminophen Gel|"Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.~Acetaminophen: Topical acetaminophen gel"
11351256|NCT03997851|OG003|Outcome|Topical Vehicle Gel|"Topical vehile gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.~Carbomer 980: Topical vehicle gel"
11351257|NCT03997851|EG000|Reported Event|Topical 5% Acetaminophen Gel|"Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.~Acetaminophen: Topical acetaminophen gel"
11351258|NCT03997851|EG001|Reported Event|Topical 2.5% Acetaminophen Gel|"Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.~Acetaminophen: Topical acetaminophen gel"
11351259|NCT03997851|EG002|Reported Event|Topical 1% Acetaminophen Gel|"Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.~Acetaminophen: Topical acetaminophen gel"
11166669|NCT01975246|OG000|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
11166670|NCT01975246|OG001|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
11166671|NCT01975246|EG000|Reported Event|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
11166672|NCT01975246|EG001|Reported Event|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
11166673|NCT01975285|BG000|Baseline|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
11166674|NCT01975285|BG001|Baseline|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
11166675|NCT01975285|BG002|Baseline|Total|Total of all reporting groups
11166676|NCT01975285|FG000|Participant Flow|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
11166677|NCT01975285|FG001|Participant Flow|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
11166678|NCT01975285|OG000|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
11166679|NCT01975285|OG001|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
11166680|NCT01975285|EG000|Reported Event|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
11166681|NCT01975285|EG001|Reported Event|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
11166682|NCT01975376|BG000|Baseline|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once every 2 weeks for upto 3 years. Participants were followed up to 40 days after the last dose.
11351260|NCT03997851|EG003|Reported Event|Topical Vehicle Gel|"Topical vehile gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.~Carbomer 980: Topical vehicle gel"
11351261|NCT03991715|BG000|Baseline|Activity Tracker|"Participants provided an activity tracker to wear and weekly reports~Activity Tracker: Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge."
11351262|NCT03991715|FG000|Participant Flow|Activity Tracker|"Participants provided an activity tracker to wear and weekly reports~Activity Tracker: Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge."
11351263|NCT03991715|OG000|Outcome|Activity Tracker|"Participants provided an activity tracker to wear and weekly reports~Activity Tracker: Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge."
11351264|NCT03991715|EG000|Reported Event|Activity Tracker|"Participants provided an activity tracker to wear and weekly reports~Activity Tracker: Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge."
11351265|NCT03990415|BG000|Baseline|Stay Strong, Stay Healthy Group|"The Stay Strong, Stay Healthy strength training group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured program to learn and progress through strength training exercises designed to increase overall fitness, flexibility, and balance.~Exercise: Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults."
11351266|NCT03990415|BG001|Baseline|Walking Group|"The walking group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured walking program to help delineate the effects of the strength training program and exercise in general.~Exercise: Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults."
11351267|NCT03990415|BG002|Baseline|Delayed Start Group|The delayed start group will not make any changes to their sedentary lifestyle and will be encouraged to not begin any exercise programs throughout the duration of the study.
11351268|NCT03990415|BG003|Baseline|Total|Total of all reporting groups
11351269|NCT03990415|FG000|Participant Flow|Stay Strong, Stay Healthy Group|"The Stay Strong, Stay Healthy strength training group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured program to learn and progress through strength training exercises designed to increase overall fitness, flexibility, and balance.~Exercise: Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults."
11351270|NCT03990415|FG001|Participant Flow|Walking Group|"The walking group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured walking program to help delineate the effects of the strength training program and exercise in general.~Exercise: Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults."
11351271|NCT03990415|FG002|Participant Flow|Delayed Start Group|The delayed start group will not make any changes to their sedentary lifestyle and will be encouraged to not begin any exercise programs throughout the duration of the study.
11351272|NCT03990415|OG000|Outcome|Stay Strong, Stay Healthy Group|"The Stay Strong, Stay Healthy strength training group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured program to learn and progress through strength training exercises designed to increase overall fitness, flexibility, and balance.~Exercise: Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults."
11351273|NCT03990415|OG001|Outcome|Walking Group|"The walking group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured walking program to help delineate the effects of the strength training program and exercise in general.~Exercise: Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults."
11351274|NCT03990415|OG002|Outcome|Delayed Start Group|The delayed start group will not make any changes to their sedentary lifestyle and will be encouraged to not begin any exercise programs throughout the duration of the study.
11351275|NCT03990415|EG000|Reported Event|Stay Strong, Stay Healthy Group|"The Stay Strong, Stay Healthy strength training group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured program to learn and progress through strength training exercises designed to increase overall fitness, flexibility, and balance.~Exercise: Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults."
11174122|NCT02019888|BG000|Baseline|Normal Hearing Adults|Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
11351276|NCT03990415|EG001|Reported Event|Walking Group|"The walking group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured walking program to help delineate the effects of the strength training program and exercise in general.~Exercise: Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults."
11351277|NCT03990415|EG002|Reported Event|Delayed Start Group|The delayed start group will not make any changes to their sedentary lifestyle and will be encouraged to not begin any exercise programs throughout the duration of the study.
11351278|NCT04002960|BG000|Baseline|INVSENSOR00036|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
11351279|NCT04002960|FG000|Participant Flow|INVSENSOR00036|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
11351280|NCT04002960|OG000|Outcome|INVSENSOR00036|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
11351281|NCT04002960|EG000|Reported Event|INVSENSOR00036|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
11351282|NCT04002973|BG000|Baseline|INVSENSOR00037|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00037.~INVSENSOR00037: Noninvasive regional oximeter."
11351283|NCT04002973|FG000|Participant Flow|INVSENSOR00037|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00037.~INVSENSOR00037: Noninvasive regional oximeter."
11351284|NCT04002973|OG000|Outcome|INVSENSOR00037|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00037.~INVSENSOR00037: Noninvasive regional oximeter."
11351285|NCT04002973|EG000|Reported Event|INVSENSOR00037|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00037.~INVSENSOR00037: Noninvasive regional oximeter."
11351286|NCT04002648|BG000|Baseline|MT-Right|Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
11351287|NCT04002648|BG001|Baseline|Sternotomy|Sternotomy: Longitudinal resection of the sternum
11351288|NCT04002648|BG002|Baseline|Total|Total of all reporting groups
11351289|NCT04002648|FG000|Participant Flow|MT-Right|Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
11351290|NCT04002648|FG001|Participant Flow|Sternotomy|Sternotomy: Longitudinal resection of the sternum
11351291|NCT04002648|OG000|Outcome|MT-Right|Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
11351292|NCT04002648|OG001|Outcome|Sternotomy|Sternotomy: Longitudinal resection of the sternum
11351293|NCT04002648|EG000|Reported Event|MT-Right|Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
11351294|NCT04002648|EG001|Reported Event|Sternotomy|Sternotomy: Longitudinal resection of the sternum
11351295|NCT03993210|BG000|Baseline|GYN Cancer Cases|"Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351296|NCT03993210|BG001|Baseline|GYN Benign Controls|"Benign gynecological (GYN) fibroids.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351297|NCT03993210|BG002|Baseline|Total|Total of all reporting groups
11351298|NCT03993210|FG000|Participant Flow|GYN Cancer Cases|"Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351299|NCT03993210|FG001|Participant Flow|GYN Benign Controls|"Benign gynecological (GYN) fibroids.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351300|NCT03993210|OG000|Outcome|GYN Cancer Cases|"Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351301|NCT03993210|OG001|Outcome|GYN Benign Controls|"Benign gynecological (GYN) fibroids.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11166683|NCT01975376|BG001|Baseline|Bococizumab (PF-04950615)|Participants received single dose of PF-04950615 150 milligrams, subcutaneous injection once every 2 weeks for upto 3 years. Participants were followed up to 40 days after the last dose.
11351302|NCT03993210|OG000|Outcome|GYN Cancer Cases|"Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.~Routine clinical standard of care pelvic MRI along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351303|NCT03993210|OG001|Outcome|GYN Benign Controls|"-Benign gynecological (GYN) fibroids.~Routine clinical standard of care pelvic MRI along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351304|NCT03993210|OG000|Outcome|GYN Cancer Cases|"Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.~Magnetic Resonance Fingerprinting (MRF): In MRF, multiple tissue properties are acquired simultaneously.~Q-space Trajectory Imaging (QTI): By using q-space trajectory encoding and a diffusion tensor distribution model, QTI improves the discrimination of diffusivity, shape, and orientation of diffusion microenvironments and therefore carries major potential for imaging the tumor microenvironment.~Magnetic Resonance Imaging Machine (MRI): MRI is routinely used in gynecologic malignancies for its ability to depict the extent of disease at diagnosis providing guidance in staging and treatment planning."
11351305|NCT03993210|OG001|Outcome|GYN Benign Controls|"Benign gynecological (GYN) fibroids.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.~Magnetic Resonance Fingerprinting (MRF): In MRF, multiple tissue properties are acquired simultaneously.~Q-space Trajectory Imaging (QTI): By using q-space trajectory encoding and a diffusion tensor distribution model, QTI improves the discrimination of diffusivity, shape, and orientation of diffusion microenvironments and therefore carries major potential for imaging the tumor microenvironment.~Magnetic Resonance Imaging Machine (MRI): MRI is routinely used in gynecologic malignancies for its ability to depict the extent of disease at diagnosis providing guidance in staging and treatment planning."
11351306|NCT03993210|EG000|Reported Event|GYN Cancer Cases|"Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351307|NCT03993210|EG001|Reported Event|GYN Benign Controls|"Benign gynecological (GYN) fibroids.~Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years."
11351308|NCT03992014|BG000|Baseline|Linerixibat Tab+[14C]Linerixibat IV/[14C] Linerixibat Oral Sol|Participants were administered a single oral dose of 90 milligram (mg) linerixibat (two tablets [tab] of 45 mg each) in fasted state followed by an intravenous (IV) infusion of 100 micrograms (μg) radiolabeled [14C]-linerixibat infused over 3 hours on Day 1 of treatment period 1. Participants received 60 milliliter (mL) of 90 mg [14C]-linerixibat oral solution (sol) in the fasted state on Day 1 of treatment period 2. The treatment periods were separated by a washout period of about 7 days (at least 13 days between oral doses). All participants were followed-up at Day 34.
11351309|NCT03992014|FG000|Participant Flow|Linerixibat Tab+[14C]Linerixibat IV/[14C] Linerixibat Oral Sol|Participants were administered a single oral dose of 90 milligram (mg) linerixibat (two tablets [tab] of 45 mg each) in fasted state followed by an intravenous (IV) infusion of 100 micrograms (μg) radiolabeled [14C]-linerixibat infused over 3 hours on Day 1 of treatment period 1. Participants received 60 milliliter (mL) of 90 mg [14C]-linerixibat oral solution (sol) in the fasted state on Day 1 of treatment period 2. The treatment periods were separated by a washout period of about 7 days (at least 13 days between oral doses). All participants were followed-up at Day 34.
11351310|NCT03992014|OG000|Outcome|Linerixibat 90 mg Oral Tablets + [14C] Linerixibat 100 μg IV|Eligible participants received 25 mL of intravenous (IV) radiolabelled [14C]-Linerixibat 100 microgram (μg) infused over 3 hours immediately after the Linerixibat 90 mg (two 45 mg) tablets orally in fasted state on Day 1 of treatment period 1.
11351311|NCT03992014|OG000|Outcome|[14C]-Linerixibat 90 Milligram Oral Solution|Participants received single 60 mL oral solution of 90 mg [14C]-Linerixibat on Day 1 of treatment period 2 in fasted state
11166684|NCT01975376|BG002|Baseline|Total|Total of all reporting groups
11166685|NCT01975376|FG000|Participant Flow|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once every 2 weeks for upto 3 years. Participants were followed up to 40 days after the last dose.
11166686|NCT01975376|FG001|Participant Flow|Bococizumab (PF-04950615)|Participants received single dose of PF-04950615 150 milligrams, subcutaneous injection once every 2 weeks for upto 3 years. Participants were followed up to 40 days after the last dose.
11166687|NCT01975376|OG000|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once every 2 weeks for upto 3 years. Participants were followed up to 40 days after the last dose.
11166688|NCT01975376|OG001|Outcome|Bococizumab (PF-04950615)|Participants received single dose of PF-04950615 150 milligrams, subcutaneous injection once every 2 weeks for upto 3 years. Participants were followed up to 40 days after the last dose.
11166689|NCT01975376|EG000|Reported Event|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once every 2 weeks for upto 3 years. Participants were followed up to 40 days after the last dose.
11351312|NCT03992014|OG000|Outcome|[14C]-Linerixibat 100 Microgram Intravenous Infusion|Participants received single 25 mL IV dose of radiolabelled [14C]-Linerixibat 100 μg infused over 3 hours on Day 1 of treatment period 1.
11166690|NCT01975376|EG001|Reported Event|Bococizumab (PF-04950615)|Participants received single dose of PF-04950615 150 milligrams, subcutaneous injection once every 2 weeks for upto 3 years. Participants were followed up to 40 days after the last dose.
11166691|NCT01975389|BG000|Baseline|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
11166692|NCT01975389|BG001|Baseline|Bococizumab (PF-04950615)|Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
11166693|NCT01975389|BG002|Baseline|Total|Total of all reporting groups
11166694|NCT01975389|FG000|Participant Flow|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
11174123|NCT02019888|BG001|Baseline|Adults With Sensory Neural Hearing Loss|Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
11351313|NCT03992014|OG001|Outcome|[14C]-Linerixibat 90 Milligram Oral Solution|Participants received single 60 mL oral solution of 90 mg [14C]-Linerixibat on Day 1 of treatment period 2 in fasted state
11351314|NCT03992014|EG000|Reported Event|Linerixibat 90 mg Oral Tablets + [14C] Linerixibat 100 μg IV|Eligible participants received 25 mL of intravenous (IV) radiolabelled [14C]-Linerixibat 100 microgram (μg) infused over 3 hours immediately after the Linerixibat 90 mg (two 45 mg) tablets orally in fasted state on Day 1 of treatment period 1
11351315|NCT03992014|EG001|Reported Event|[14C]-Linerixibat 90 Milligram Oral Solution|Participants received single 60 mL oral solution of 90 mg [14C]-Linerixibat on Day 1 of treatment period 2 in fasted state
11351316|NCT03990649|BG000|Baseline|Double-Blind Treatment Period - Part A: Placebo|Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
11166695|NCT01975389|FG001|Participant Flow|Bococizumab (PF-04950615)|Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
11166696|NCT01975389|OG000|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
11166697|NCT01975389|OG001|Outcome|Bococizumab (PF-04950615)|Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
11166698|NCT01975389|EG000|Reported Event|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
11166699|NCT01975389|EG001|Reported Event|Bococizumab (PF-04950615)|Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
11351317|NCT03990649|BG001|Baseline|Double-Blind Treatment Period - Part A: Soticlestat|Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
11351318|NCT03990649|BG002|Baseline|Total|Total of all reporting groups
11166700|NCT01975428|BG000|Baseline|Control|All study participants, including participants randomized to the control arm, were enrolled in the HealthComp disease management program, which involved outreach by HealthComp nursing staff for purposes of relaying medical education and wellness information with regard to disease prevention and chronic disease management.
11166701|NCT01975428|BG001|Baseline|DM Pgm + Device|"All study participants, including participants randomized to the control arm, were enrolled in the HealthComp disease management program, which involved outreach by HealthComp nursing staff for purposes of relaying medical education and wellness information with regard to disease prevention and chronic disease management.~iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.~iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.~iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.~Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.~Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week."
11166702|NCT01975428|BG002|Baseline|Total|Total of all reporting groups
11166703|NCT01975428|FG000|Participant Flow|Control|"Disease Management Program~This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems."
11166704|NCT01975428|FG001|Participant Flow|DM Pgm + Device|"This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.~iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.~iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.~iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.~Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.~Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week."
11166705|NCT01975428|OG000|Outcome|Control|"Disease Management Program~This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems."
11351319|NCT03990649|FG000|Participant Flow|Double-Blind Treatment Period - Part A: Placebo|Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
11229725|NCT02400749|OG001|Outcome|Placebo Followed by Apremilast|"Patients will receive placebo until Week 16 and then receive apremilast until Week 32~Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.~Patients will be provided a titration blister pack containing placebo at the Day 0 visit and apremilast 10 mg, 20 mg and 30 mg at the Week 16 visit (refer to section 6.1). Following the 6 day titration period (for Day 0 and Week 16), patients will receive blister packs containing apremilast 30 mg bid or placebo bid."
11229726|NCT02400749|EG000|Reported Event|Apremilast|"Patients will receive apremilast until Week 32.~Apremilast: Apremilast tablets provided to sites in blister cards.~Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid."
11229727|NCT02400749|EG001|Reported Event|Placebo Followed by Apremilast|"Patients will receive placebo until Week 16 and then receive apremilast until Week 32~Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.~Patients will be provided a titration blister pack containing placebo at the Day 0 visit and apremilast 10 mg, 20 mg and 30 mg at the Week 16 visit (refer to section 6.1). Following the 6 day titration period (for Day 0 and Week 16), patients will receive blister packs containing apremilast 30 mg bid or placebo bid."
11229728|NCT02400905|BG000|Baseline|BioMimics 3D Stent|Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
11229729|NCT02400905|FG000|Participant Flow|BioMimics 3D Stent|Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
11229730|NCT02400905|OG000|Outcome|BioMimics 3D Stent|Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
11229731|NCT02400905|OG000|Outcome|BioMimics 3D Stent|"Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System~BioMimics 3D Stent System: Femoropopliteal stenting"
11229732|NCT02400905|EG000|Reported Event|BioMimics 3D Stent|Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
11229733|NCT02400996|BG000|Baseline|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
11229734|NCT02400996|FG000|Participant Flow|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
11229735|NCT02400996|OG000|Outcome|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
11229736|NCT02400996|EG000|Reported Event|Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
11229737|NCT02401022|BG000|Baseline|AZD8529 Low Dose|Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
11229738|NCT02401022|BG001|Baseline|AZD8529 High Dose|Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
11229739|NCT02401022|BG002|Baseline|Total|Total of all reporting groups
11229740|NCT02401022|FG000|Participant Flow|AZD8529 Low Dose|Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
11229741|NCT02401022|FG001|Participant Flow|AZD8529 High Dose|Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
11229742|NCT02401022|OG000|Outcome|AZD8529 Low Dose|Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
11229743|NCT02401022|OG001|Outcome|AZD8529 High Dose|Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
11229744|NCT02401022|EG000|Reported Event|AZD8529 Low Dose|Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
11229745|NCT02401022|EG001|Reported Event|AZD8529 High Dose|Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
11229746|NCT02401048|BG000|Baseline|Phase 1b/2: Follicular Lymphoma Expansion Cohort:|All participants who received at least one dose of study treatment.
11229747|NCT02401048|BG001|Baseline|Phase 1b/2: Diffuse Large B-cell Lymphoma Expansion Cohort:|All participants who received at least one dose of study treatment.
11229748|NCT02401048|BG002|Baseline|Total|Total of all reporting groups
11229749|NCT02401048|FG000|Participant Flow|Phase 1b/ 2: Follicular Lymphoma Expansion Cohort|In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 explored in cohort 1 and followed a 6+3 dose de-escalation design. Phase 2 used the phase 1b starting dose.
11229750|NCT02401048|FG001|Participant Flow|Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort|In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 explored in cohort 1 and followed a 6+3 dose de-escalation design. Phase 2 used the phase 1b starting dose.
11229751|NCT02401048|OG000|Outcome|Phase 1b/ 2: Follicular Lymphoma Expansion Cohort|All participants who received at least one dose of study treatment.
11229752|NCT02401048|OG001|Outcome|Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort|All participants who received at least one dose of study treatment.
11229753|NCT02401048|OG000|Outcome|Phase 1b/ 2: Follicular Lymphoma Expansion Cohort|All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data.
11229754|NCT02401048|OG001|Outcome|Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort|All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data.
11351320|NCT03990649|FG001|Participant Flow|Double-Blind Treatment Period - Part A: Soticlestat|Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
11351321|NCT03990649|FG002|Participant Flow|Open-Label Extension Period - Part B: Soticlestat|Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
11166706|NCT01975428|OG001|Outcome|DM Pgm + Device|"This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.~iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.~iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.~iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.~Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.~Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week."
11166707|NCT01975428|EG000|Reported Event|Control|This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
11166708|NCT01975428|EG001|Reported Event|DM Pgm + Device|"This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.~iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.~iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.~iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.~Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.~Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week."
11166709|NCT01975519|BG000|Baseline|8 mg/kg TRC105 + Pazopanib|8 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166710|NCT01975519|BG001|Baseline|10 mg/kg TRC105 + Pazopanib|10 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166711|NCT01975519|BG002|Baseline|Total|Total of all reporting groups
11166712|NCT01975519|FG000|Participant Flow|8 mg/kg TRC105 + Pazopanib|8 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166713|NCT01975519|FG001|Participant Flow|10 mg/kg TRC105 + Pazopanib|10 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166714|NCT01975519|OG000|Outcome|TRC105 Plus Pazopanib|All patients in Phase 1b portion of study who received TRC105 + Pazopanib TRC105: IV (8 mg/kg or 10 mg/kg). Pazopanib: oral (800 mg)
11166715|NCT01975519|OG000|Outcome|8 mg/kg TRC105 + Pazopanib|All patients who received 8 mg/kg TRC105 + Pazopanib
11166716|NCT01975519|OG001|Outcome|10 mg/kg TRC105 + Pazopanib|All patients who received 10 mg/kg TRC105 + Pazopanib
11166717|NCT01975519|OG000|Outcome|10 mg/kg TRC105 + Pazopanib With Angiosarcoma|10 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166718|NCT01975519|OG000|Outcome|10 mg/kg TRC105 + Pazopanib|All patients who received hybrid dose of 10 mg/kg TRC105 weekly followed by 15 mg/kg every other week in combination with 800 mg pazopanib daily
11166719|NCT01975519|OG000|Outcome|8 mg/kg TRC105 + Pazopanib|All patients who received TRC105 + Pazopanib TRC105: IV 8 mg/kg and Pazopanib: oral (800 mg)
11166720|NCT01975519|OG001|Outcome|10 mg/kg TRC105 + Pazopanib|All patients who received TRC105 + Pazopanib TRC105: IV 10 mg/kg and Pazopanib: oral (800 mg)
11166721|NCT01975519|OG000|Outcome|TRC105 Plus Pazopanib|All patients in Phase 1b and Phase 2 portion of study who received TRC105 + Pazopanib TRC105: IV (8 mg/kg or 10 mg/kg). Pazopanib: oral (800 mg)
11166722|NCT01975519|OG000|Outcome|8 mg/kg TRC105 + Pazopanib|8 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166723|NCT01975519|OG001|Outcome|10 mg/kg TRC105 + Pazopanib|10 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166724|NCT01975519|EG000|Reported Event|8 mg/kg TRC105 + Pazopanib|8 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166725|NCT01975519|EG001|Reported Event|10 mg/kg TRC105 + Pazopanib|10 mg/kg of TRC105 in combination with standard dose pazopanib in patients with advanced soft tissue sarcoma.
11166726|NCT01975675|BG000|Baseline|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
11166727|NCT01975675|BG001|Baseline|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
11166728|NCT01975675|BG002|Baseline|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
11166729|NCT01975675|BG003|Baseline|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
11166730|NCT01975675|BG004|Baseline|Total|Total of all reporting groups
11351322|NCT03990649|OG000|Outcome|Double-Blind Treatment Period - Part A: Placebo|Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
11351323|NCT03990649|OG001|Outcome|Double-Blind Treatment Period - Part A: Soticlestat|Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
11351324|NCT03990649|EG000|Reported Event|Double-Blind Treatment Period - Part A: Placebo|Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
11351325|NCT03990649|EG001|Reported Event|Double-Blind Treatment Period - Part A: Soticlestat|Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
11351326|NCT03990649|EG002|Reported Event|Open-Label Extension Period - Part B: Soticlestat|Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
11351327|NCT04002791|BG000|Baseline|Group 1: TR Band Arm|"Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using Patent hemostasis protocol to achieve full hemostasis.~VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression"
11166731|NCT01975675|FG000|Participant Flow|LDV/SOF (Treatment Naive)|Treatment-naive participants received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
11166732|NCT01975675|FG001|Participant Flow|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus ribavirin (RBV) tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
11166733|NCT01975675|FG002|Participant Flow|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
11166734|NCT01975675|FG003|Participant Flow|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
11166735|NCT01975675|OG000|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
11166736|NCT01975675|OG001|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
11166737|NCT01975675|OG002|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
11166738|NCT01975675|OG003|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
11166739|NCT01975675|OG000|Outcome|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
11166740|NCT01975675|OG001|Outcome|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
11166741|NCT01975675|EG000|Reported Event|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
11166742|NCT01975675|EG001|Reported Event|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
11166743|NCT01975701|BG000|Baseline|BGJ398X|125 mg BGJ398 non surgical
11166744|NCT01975701|FG000|Participant Flow|BGJ398X|125 mg BGJ398 non surgical
11166745|NCT01975701|OG000|Outcome|BGJ398X|125 mg BGJ398 non surgical
11166746|NCT01975701|EG000|Reported Event|Non Surg BGJ398 125 mg|Non Surg BGJ398 125 mg
11166747|NCT01975831|BG000|Baseline|Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11174124|NCT02019888|BG002|Baseline|Adults With Middle Ear Disorders|Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
11174125|NCT02019888|BG003|Baseline|Total|Total of all reporting groups
11166748|NCT01975831|BG001|Baseline|Escalation: 1 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166749|NCT01975831|BG002|Baseline|Escalation: 3 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166750|NCT01975831|BG003|Baseline|Escalation: 3 mg/kg Durva + 1 mg/kg Treme|"Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166751|NCT01975831|BG004|Baseline|Expansion: Ovarian Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166752|NCT01975831|BG005|Baseline|Expansion: Colorectal Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166753|NCT01975831|BG006|Baseline|Expansion: Non-triple Negative Breast Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166754|NCT01975831|BG007|Baseline|Expansion: Renal Cell Carcinoma|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166755|NCT01975831|BG008|Baseline|Expansion: Cervical Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166756|NCT01975831|BG009|Baseline|Total|Total of all reporting groups
11166757|NCT01975831|FG000|Participant Flow|Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (0.3 mg/kg every 2 weeks [Q2W] for 13 cycles) and tremelimumab (3 mg/kg every 4 weeks [Q4W] for 6 cycles, then every 12 weeks [Q12W]). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as intravenous (IV) infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166758|NCT01975831|FG001|Participant Flow|Escalation: 1 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166759|NCT01975831|FG002|Participant Flow|Escalation: 3 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166760|NCT01975831|FG003|Participant Flow|Escalation: 3 mg/kg Durva + 1 mg/kg Treme|"Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166761|NCT01975831|FG004|Participant Flow|Expansion: Ovarian Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11229755|NCT02401048|OG000|Outcome|Phase 1b/ 2: Follicular Lymphoma & DLBCL Expansion Cohort|All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data.
11351328|NCT04002791|BG001|Baseline|Group 2: Vaso-band Arm|"Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.~VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression"
11351329|NCT04002791|BG002|Baseline|Total|Total of all reporting groups
11351330|NCT04002791|FG000|Participant Flow|Group 1: TR Band Arm|"Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using Patent hemostasis protocol to achieve full hemostasis.~VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression"
11351331|NCT04002791|FG001|Participant Flow|Group 2: Vaso-band Arm|"Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.~VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression"
11351332|NCT04002791|OG000|Outcome|Group 1: TR Band Arm|"Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using Patent hemostasis protocol to achieve full hemostasis.~VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression"
11351333|NCT04002791|OG001|Outcome|Group 2: Vaso-band Arm|"Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.~VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression"
11351334|NCT04002791|EG000|Reported Event|Group 1: TR Band Arm|"Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using Patent hemostasis protocol to achieve full hemostasis.~VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression"
11351335|NCT04002791|EG001|Reported Event|Group 2: Vaso-band Arm|"Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.~VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression"
11351336|NCT04000581|BG000|Baseline|Arm I (Usual Care)|"Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.~Best Practice: Receive standard of care~Questionnaire Administration: Ancillary studies"
11351337|NCT04000581|BG001|Baseline|Arm II (Additional Mobility)|"Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.~Physical Activity: Walk for minimum 30 minutes per day~Questionnaire Administration: Ancillary studies"
11351338|NCT04000581|BG002|Baseline|Total|Total of all reporting groups
11351339|NCT04000581|FG000|Participant Flow|Arm I (Usual Care)|"Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.~Best Practice: Receive standard of care~Questionnaire Administration: Ancillary studies"
11351340|NCT04000581|FG001|Participant Flow|Arm II (Additional Mobility)|"Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.~Physical Activity: Walk for minimum 30 minutes per day~Questionnaire Administration: Ancillary studies"
11351341|NCT04000581|OG000|Outcome|Arm I (Usual Care)|"Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.~Best Practice: Receive standard of care~Questionnaire Administration: Ancillary studies"
11351342|NCT04000581|OG001|Outcome|Arm II (Additional Mobility)|"Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.~Physical Activity: Walk for minimum 30 minutes per day~Questionnaire Administration: Ancillary studies"
11351343|NCT04000581|EG000|Reported Event|Arm I (Usual Care)|"Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.~Best Practice: Receive standard of care~Questionnaire Administration: Ancillary studies"
11174126|NCT02019888|FG000|Participant Flow|Normal Hearing Adults|Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
11351344|NCT04000581|EG001|Reported Event|Arm II (Additional Mobility)|"Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.~Physical Activity: Walk for minimum 30 minutes per day~Questionnaire Administration: Ancillary studies"
11351345|NCT03996694|BG000|Baseline|All Arms|Subject disposition for all arms
11351346|NCT03996694|FG000|Participant Flow|ABCDEF|Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
11351347|NCT03996694|FG001|Participant Flow|BCDEFA|Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
11351348|NCT03996694|FG002|Participant Flow|CDEFAB|Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
11351349|NCT03996694|FG003|Participant Flow|DEFABC|Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
11351350|NCT03996694|FG004|Participant Flow|EFABCD|Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
11351351|NCT03996694|FG005|Participant Flow|FABCDE|Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
11351352|NCT03996694|OG000|Outcome|Treatment A: Belbuca 300 µg and Oral Placebo|"Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Belbuca 300 µg: Belbuca 300 µg buccal film"
11351353|NCT03996694|OG001|Outcome|Treatment B: Belbuca 600 µg and Oral Placebo|"Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Belbuca 600 µg: Belbuca 600 µg buccal film"
11351354|NCT03996694|OG002|Outcome|Treatment C: Belbuca 900 µg and Oral Placebo|"Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Belbuca 900 µg: Belbuca 900 µg buccal film"
11351355|NCT03996694|OG003|Outcome|Treatment D: Oxycodone 30 mg and Buccal Placebo|"Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Oxycodone 30 mg: Oxycodone 30 mg capsule"
11351356|NCT03996694|OG004|Outcome|Treatment E: Oxycodone 60 mg and Buccal Placebo|"Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Oxycodone 60 mg: Oxycodone 60 mg capsule"
11351357|NCT03996694|OG005|Outcome|Treatment F: Oral Placebo and Buccal Placebo|"Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Placebo: placebo buccal film and oral placebo"
11351358|NCT03996694|EG000|Reported Event|Treatment A: Belbuca 300 µg and Oral Placebo|"Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Belbuca 300 µg: Belbuca 300 µg buccal film"
11351359|NCT03996694|EG001|Reported Event|Treatment B: Belbuca 600 µg and Oral Placebo|"Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Belbuca 600 µg: Belbuca 600 µg buccal film"
11351360|NCT03996694|EG002|Reported Event|Treatment C: Belbuca 900 µg and Oral Placebo|"Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Belbuca 900 µg: Belbuca 900 µg buccal film"
11351361|NCT03996694|EG003|Reported Event|Treatment D: Oxycodone 30 mg and Buccal Placebo|"Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Oxycodone 30 mg: Oxycodone 30 mg capsule"
11351362|NCT03996694|EG004|Reported Event|Treatment E: Oxycodone 60 mg and Buccal Placebo|"Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Oxycodone 60 mg: Oxycodone 60 mg capsule"
11351363|NCT03996694|EG005|Reported Event|Treatment F: Oral Placebo and Buccal Placebo|"Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.~Placebo: placebo buccal film and oral placebo"
11351364|NCT03988907|BG000|Baseline|Part 1|Participants received a dose of 5 milligram (mg) risdiplam once daily (QD) for 14 consecutive days. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351365|NCT03988907|BG001|Baseline|Part 2|All study participants received a single oral dose of 2 mg midazolam on Day 1. On Day 3, the 14-day QD treatment period with 8 mg risdiplam began. The precise dose was based on the results of Part 1, with single dose administration of 2 mg midazolam again on Day 15 (1 hour after the thirteenth dose of 8 mg risdiplam). On Day 16, participants received 8 mg risdiplam. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1, 3, and 15 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351366|NCT03988907|BG002|Baseline|Total|Total of all reporting groups
11351367|NCT03988907|FG000|Participant Flow|Part 1|Participants received a dose of 5 milligram (mg) risdiplam once daily (QD) for 14 consecutive days. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351368|NCT03988907|FG001|Participant Flow|Part 2|All study participants received a single oral dose of 2 mg midazolam on Day 1. On Day 3, the 14-day QD treatment period with 8 mg risdiplam began. The precise dose was based on the results of Part 1, with single dose administration of 2 mg midazolam again on Day 15 (1 hour after the thirteenth dose of 8 mg risdiplam). On Day 16, participants received 8 mg risdiplam. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1, 3, and 15 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351369|NCT03988907|OG000|Outcome|2 mg Midazolam (Reference)|Participants received a single oral dose of 2 mg of midazolam on Day 1 of the treatment sequence. Participants were fasted overnight (at least 8 hours) prior to dosing on and refrained from consuming water from 1 hour predose until 2 hours postdose, excluding the amount of water consumed at dosing.
11351370|NCT03988907|OG001|Outcome|2 mg Midazolam + 8 mg Risdiplam QD (Test)|Participants received 8 mg risdiplam QD orally for 14 consecutive days (Day 3 to Day 14), and on Day 15 participants received a single oral dose of 2 mg of midazolam again. Participants were fasted overnight (at least 8 hours) prior to dosing on Days 3, and 15 and refrained from consuming water from 1 hour predose until 2 hours postdose, excluding the amount of water consumed at dosing.
11351371|NCT03988907|OG000|Outcome|5 mg Risdiplam|Participants received a dose of 5 milligram (mg) risdiplam once daily (QD) for 14 consecutive days. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351372|NCT03988907|OG001|Outcome|M1 Risdiplam|Participants received a dose of 5 mg risdiplam QD for 14 consecutive days. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351373|NCT03988907|OG000|Outcome|8 mg Risdiplam QD|Participants received 8 mg risdiplam QD orally for 14 consecutive days (Day 3 to Day 14), and the last dose of 8 mg risdiplam was administered orally on Day 16. Participants were fasted overnight (at least 8 hours) prior to dosing on Days 3, and 16 and refrained from consuming water from 1 hour predose until 2 hours postdose, excluding the amount of water consumed at dosing.
11351374|NCT03988907|OG001|Outcome|M1 of Risdiplam|Participants received 8 mg risdiplam QD orally for 14 consecutive days (Day 3 to Day 14), and the last dose of 8 mg risdiplam was administered orally on Day 16. Participants were fasted overnight (at least 8 hours) prior to dosing on Days 3, and 16 and refrained from consuming water from 1 hour predose until 2 hours postdose, excluding the amount of water consumed at dosing.
11351375|NCT03988907|OG000|Outcome|Part 1|Participants received a dose of 5 milligram (mg) risdiplam once daily (QD) for 14 consecutive days. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351376|NCT03988907|OG001|Outcome|Part 2: 8 mg Risdiplam QD|Participants received 8 mg risdiplam QD orally for 14 consecutive days (Day 3 to Day 14), and the last dose of 8 mg risdiplam was administered orally on Day 16. Participants were fasted overnight (at least 8 hours) prior to dosing on Days 3, and 16 and refrained from consuming water from 1 hour predose until 2 hours postdose, excluding the amount of water consumed at dosing.
11351377|NCT03988907|EG000|Reported Event|Part 1|Participants received a dose of 5 milligram (mg) risdiplam once daily (QD) for 14 consecutive days. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351378|NCT03988907|EG001|Reported Event|Part 2|All study participants received a single oral dose of 2 mg midazolam on Day 1. On Day 3, the 14-day QD treatment period with 8 mg risdiplam began. The precise dose was based on the results of Part 1, with single dose administration of 2 mg midazolam again on Day 15 (1 hour after the thirteenth dose of 8 mg risdiplam). On Day 16, participants received 8 mg risdiplam. Participants were fasted overnight (at least 8 hours) prior to dosing on Day 1, 3, and 15 and refrained from consuming water from 1 hour pre-dose until 2 hours post-dose.
11351379|NCT03988088|BG000|Baseline|100 mg Lasmiditan|Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
11351380|NCT03988088|BG001|Baseline|200 mg Lasmiditan|Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
11351381|NCT03988088|BG002|Baseline|Total|Total of all reporting groups
11174127|NCT02019888|FG001|Participant Flow|Adults With Sensory Neural Hearing Loss|Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
11351382|NCT03988088|FG000|Participant Flow|100 Milligrams (mg) Lasmiditan|Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
11351383|NCT03988088|FG001|Participant Flow|200 mg Lasmiditan|Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
11351384|NCT03988088|FG002|Participant Flow|50 mg Lasmiditan-Addendum|Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.
11351385|NCT03988088|FG003|Participant Flow|100 mg Lasmiditan-Addendum|Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.
11351386|NCT03988088|OG000|Outcome|100 mg Lasmiditan|Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
11351387|NCT03988088|OG001|Outcome|200 mg Lasmiditan|Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
11351388|NCT03988088|EG000|Reported Event|100 mg Lasmiditan|Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
11351389|NCT03988088|EG001|Reported Event|200 mg Lasmiditan|Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
11351390|NCT03988088|EG002|Reported Event|50 mg Lasmiditan-Addendum|Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.
11351391|NCT03988088|EG003|Reported Event|100 mg Lasmiditan-Addendum|Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.
11351392|NCT03980522|BG000|Baseline|KPL-914: Part 1 Participants|"Symptomatic participants with RIP with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351393|NCT03980522|BG001|Baseline|KPL-914: Part 2 Participants|"Symptomatic participants with RIP with CRP ≤ 1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac MRI confirmed by the imaging core lab received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351394|NCT03980522|BG002|Baseline|KPL-914: Part 3 Participants|"Participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351395|NCT03980522|BG003|Baseline|KPL-914: Part 4 Participants|"Symptomatic participants with recurrent PPS with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351396|NCT03980522|BG004|Baseline|KPL-914: Part 5 Participants|"Participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351397|NCT03980522|BG005|Baseline|Total|Total of all reporting groups
11351398|NCT03980522|FG000|Participant Flow|KPL-914: Part 1 Participants|"Symptomatic participants with recurrent idiopathic pericarditis (RIP) with an elevated marker of systemic inflammation (C-reactive protein [CRP] > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg subcutaneous (SC), delivered as 2 subcutaneous (SC) injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week extension period (EP) in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351399|NCT03980522|FG001|Participant Flow|KPL-914: Part 2 Participants|"Symptomatic participants with RIP with CRP ≤ 1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac magnetic resonance imaging (MRI) confirmed by the imaging core lab received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351400|NCT03980522|FG002|Participant Flow|KPL-914: Part 3 Participants|"Participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351401|NCT03980522|FG003|Participant Flow|KPL-914: Part 4 Participants|"Symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351402|NCT03980522|FG004|Participant Flow|KPL-914: Part 5 Participants|"Participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351403|NCT03980522|OG000|Outcome|KPL-914: Part 1 Participants|"Symptomatic participants with RIP with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351404|NCT03980522|OG001|Outcome|KPL-914: Part 2 Participants|"Symptomatic participants with RIP with CRP ≤ 1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac MRI confirmed by the imaging core lab received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351405|NCT03980522|OG002|Outcome|KPL-914: Part 4 Participants|"Symptomatic participants with recurrent PPS with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351406|NCT03980522|OG000|Outcome|KPL-914: Part 3 Participants|"Participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351407|NCT03980522|OG001|Outcome|KPL-914: Part 5 Participants|"Participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11166762|NCT01975831|FG005|Participant Flow|Expansion: Colorectal Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166763|NCT01975831|FG006|Participant Flow|Expansion: Non-triple Negative Breast Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166764|NCT01975831|FG007|Participant Flow|Expansion: Renal Cell Carcinoma|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166765|NCT01975831|FG008|Participant Flow|Expansion: Cervical Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166766|NCT01975831|OG000|Outcome|Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166767|NCT01975831|OG001|Outcome|Escalation: 1 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166768|NCT01975831|OG002|Outcome|Escalation: 3 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166769|NCT01975831|OG003|Outcome|Escalation: 3 mg/kg Durva + 1 mg/kg Treme|"Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166770|NCT01975831|OG004|Outcome|Expansion: Ovarian Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166771|NCT01975831|OG005|Outcome|Expansion: Colorectal Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166772|NCT01975831|OG006|Outcome|Expansion: Non-triple Negative Breast Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166773|NCT01975831|OG007|Outcome|Expansion: Renal Cell Carcinoma|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166774|NCT01975831|OG008|Outcome|Expansion: Cervical Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166775|NCT01975831|EG000|Reported Event|Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166776|NCT01975831|EG001|Reported Event|Escalation: 1 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166777|NCT01975831|EG002|Reported Event|Escalation: 3 mg/kg Durva + 3 mg/kg Treme|"Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166778|NCT01975831|EG003|Reported Event|Escalation: 3 mg/kg Durva + 1 mg/kg Treme|"Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166779|NCT01975831|EG004|Reported Event|Expansion: Ovarian Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166780|NCT01975831|EG005|Reported Event|Expansion: Colorectal Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166781|NCT01975831|EG006|Reported Event|Expansion: Non-triple Negative Breast Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166782|NCT01975831|EG007|Reported Event|Expansion: Renal Cell Carcinoma|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166783|NCT01975831|EG008|Reported Event|Expansion: Cervical Cancer|"Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.~Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days."
11166784|NCT01975909|BG000|Baseline|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
11166785|NCT01975909|BG001|Baseline|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
11166786|NCT01975909|BG002|Baseline|Total|Total of all reporting groups
11166787|NCT01975909|FG000|Participant Flow|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
11166788|NCT01975909|FG001|Participant Flow|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
11229756|NCT02401048|OG000|Outcome|Phase 1b/ 2: Follicular Lymphoma Expansion Cohort|All participants who received at least one dose of study treatment and had evaluable pharmacodynamics data.
11229757|NCT02401048|OG001|Outcome|Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort|All participants who received at least one dose of study treatment and had evaluable pharmacodynamics data.
11229758|NCT02401048|EG000|Reported Event|Phase 1b/2: Follicular Lymphoma Expansion Cohort:|All subjects who received at least one dose of study treatment.
11229759|NCT02401048|EG001|Reported Event|Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort:|All subjects who received at least one dose of study treatment.
11229760|NCT02401230|BG000|Baseline|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229761|NCT02401230|BG001|Baseline|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
11229762|NCT02401230|BG002|Baseline|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229763|NCT02401230|BG003|Baseline|Total|Total of all reporting groups
11229764|NCT02401230|FG000|Participant Flow|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229765|NCT02401230|FG001|Participant Flow|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days.~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
11229766|NCT02401230|FG002|Participant Flow|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229767|NCT02401230|OG000|Outcome|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229768|NCT02401230|OG001|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days.~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
11229769|NCT02401230|OG002|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229770|NCT02401230|OG000|Outcome|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229771|NCT02401230|OG001|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
11229772|NCT02401230|OG000|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
11229773|NCT02401230|OG001|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229774|NCT02401230|EG000|Reported Event|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229775|NCT02401230|EG001|Reported Event|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days.~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
11229776|NCT02401230|EG002|Reported Event|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
11229777|NCT02401256|BG000|Baseline|CYP2B6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg). These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4). The study has 4 phases: Phase 1 (control, baseline)Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg (CYP2b6), montelukast 10 mg (CYP2C8) and rosuvastatin 5 mg (OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined. Phase 2 (inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3 (home treatment with efavirenz): Subjects is taken take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected in all phases. Blood draws is made in phase 3 for trough concentration measurements.
11229778|NCT02401256|FG000|Participant Flow|CYP2B6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg). These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4). The study has 4 phases: Phase 1 (control, baseline)Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg (CYP2b6), montelukast 10 mg (CYP2C8) and rosuvastatin 5 mg (OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined. Phase 2 (inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3 (home treatment with efavirenz): Subjects is taken take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected in all phases. Blood draws is made in phase 3 for trough concentration measurements.
11229779|NCT02401256|OG000|Outcome|CYP2B6*1/*1|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg).These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4).The study has 4 phases:Phase 1(control/baseline).Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg(CYP2B6), montelukast 10 mg(CYP2C8) and rosuvastatin 5 mg(OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined.Phase 2(inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3(home treatment with efavirenz):Subjects take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2.Blood samples (0 to 120 hrs) and urine voided over 48 hrs(Phases 1, 2 and 4) are collected in all phases.Blood draws is made in phase 3 for trough concentration measurements. Volunteers were genotyped and stratified according to CYP2B6*1/*1, *1/*6, and *6/*6 alleles
11229780|NCT02401256|OG001|Outcome|CYP2B6*1/*6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg).These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4).The study has 4 phases:Phase 1(control/baseline).Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg(CYP2B6), montelukast 10 mg(CYP2C8) and rosuvastatin 5 mg(OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined.Phase 2(inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3(home treatment with efavirenz):Subjects take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2.Blood samples (0 to 120 hrs) and urine voided over 48 hrs(Phases 1, 2 and 4) are collected in all phases.Blood draws is made in phase 3 for trough concentration measurements. Volunteers were genotyped and stratified according to CYP2B6*1/*1, *1/*6, and *6/*6 alleles
11229781|NCT02401256|OG002|Outcome|CYP2B6*6/*6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg).These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4).The study has 4 phases:Phase 1(control/baseline).Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg(CYP2B6), montelukast 10 mg(CYP2C8) and rosuvastatin 5 mg(OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined.Phase 2(inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3(home treatment with efavirenz):Subjects take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2.Blood samples (0 to 120 hrs) and urine voided over 48 hrs(Phases 1, 2 and 4) are collected in all phases.Blood draws is made in phase 3 for trough concentration measurements. Volunteers were genotyped and stratified according to CYP2B6*1/*1, *1/*6, and *6/*6 alleles
11229782|NCT02401256|EG000|Reported Event|CYP2B6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg). These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4). The study has 4 phases: Phase 1 (control, baseline)Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg (CYP2b6), montelukast 10 mg (CYP2C8) and rosuvastatin 5 mg (OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined. Phase 2 (inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3 (home treatment with efavirenz): Subjects is taken take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected in all phases. Blood draws is made in phase 3 for trough concentration measurements.
11229783|NCT02401412|BG000|Baseline|Test Ostomy Barrier|"The test product is a new Hollister ostomy barrier.~Test Ostomy Barrier"
11229784|NCT02401412|BG001|Baseline|Control Ostomy Barrier|"The control product is a currently marketed Hollister ostomy barrier.~Control Ostomy Barrier"
11229785|NCT02401412|BG002|Baseline|Total|Total of all reporting groups
11229786|NCT02401412|FG000|Participant Flow|Test Ostomy Barrier|"The test product is a new Hollister ostomy barrier.~Test Ostomy Barrier"
11229787|NCT02401412|FG001|Participant Flow|Control Ostomy Barrier|"The control product is a currently marketed Hollister ostomy barrier.~Control Ostomy Barrier"
11229788|NCT02401412|OG000|Outcome|Test Ostomy Barrier|"The test product is a new Hollister ostomy barrier.~Test Ostomy Barrier"
11229789|NCT02401412|OG001|Outcome|Control Ostomy Barrier|"The control product is a currently marketed Hollister ostomy barrier.~Control Ostomy Barrier"
11229790|NCT02401412|EG000|Reported Event|Test Ostomy Barrier|"The test product is a new Hollister ostomy barrier.~Test Ostomy Barrier"
11229791|NCT02401412|EG001|Reported Event|Control Ostomy Barrier|"The control product is a currently marketed Hollister ostomy barrier.~Control Ostomy Barrier"
11229792|NCT02401464|BG000|Baseline|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
11229793|NCT02401464|BG001|Baseline|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
11229794|NCT02401464|BG002|Baseline|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
11229795|NCT02401464|BG003|Baseline|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
11229796|NCT02401464|BG004|Baseline|Total|Total of all reporting groups
11166789|NCT01975909|OG000|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
11166790|NCT01975909|OG001|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
11166791|NCT01975909|EG000|Reported Event|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
11166792|NCT01975909|EG001|Reported Event|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
11166793|NCT01975922|BG000|Baseline|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
11166794|NCT01975922|BG001|Baseline|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
11166795|NCT01975922|BG002|Baseline|Total|Total of all reporting groups
11166796|NCT01975922|FG000|Participant Flow|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
11166797|NCT01975922|FG001|Participant Flow|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
11166798|NCT01975922|OG000|Outcome|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
11166799|NCT01975922|OG001|Outcome|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
11166800|NCT01975922|EG000|Reported Event|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
11166801|NCT01975922|EG001|Reported Event|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
11166802|NCT01975935|BG000|Baseline|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
11166803|NCT01975935|BG001|Baseline|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
11166804|NCT01975935|BG002|Baseline|Total|Total of all reporting groups
11166805|NCT01975935|FG000|Participant Flow|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
11166806|NCT01975935|FG001|Participant Flow|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
11166807|NCT01975935|OG000|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
11166808|NCT01975935|OG001|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
11166809|NCT01975935|EG000|Reported Event|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
11166810|NCT01975935|EG001|Reported Event|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
11174128|NCT02019888|FG002|Participant Flow|Adults With Middle Ear Disorders|Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
11351408|NCT03980522|EG000|Reported Event|KPL-914: Part 1 Participants|"Symptomatic participants with RIP with an elevated marker of systemic inflammation (CRP > 1 mg/dL) receivedKPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351409|NCT03980522|EG001|Reported Event|KPL-914: Part 2 Participants|"Symptomatic participants with RIP with CRP ≤ 1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac MRI confirmed by the imaging core lab received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351410|NCT03980522|EG002|Reported Event|KPL-914: Part 3 Participants|"Participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351411|NCT03980522|EG003|Reported Event|KPL-914: Part 4 Participants|"Symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP > 1mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351412|NCT03980522|EG004|Reported Event|KPL-914: Part 5 Participants|"Participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.~Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks."
11351413|NCT03999684|BG000|Baseline|Tretinoin|"-Participants will receive Tretinoin orally divided over two daily doses for days 1 through 14 of a 28-day cycle~Tretinoin: ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)"
11351414|NCT03999684|FG000|Participant Flow|Tretinoin|"-Participants will receive Tretinoin orally divided over two daily doses for days 1 through 14 of a 28-day cycle~Tretinoin: ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)"
11351415|NCT03999684|OG000|Outcome|Tretinoin|"-Participants will receive Tretinoin orally divided over two daily doses for days 1 through 14 of a 28-day cycle~Tretinoin: ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)"
11351416|NCT03999684|EG000|Reported Event|Tretinoin|"-Participants will receive Tretinoin orally divided over two daily doses for days 1 through 14 of a 28-day cycle~Tretinoin: ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)"
11357192|NCT03763058|EG000|Reported Event|Music Intervention|"The music intervention is administered via a smartphone- (and computer-) based application called Music Care.~Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the U technique designed to gradually relax the listener. The U technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.~Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month."
11357193|NCT03762993|BG000|Baseline|Healthy Adults|"Participants will complete vocal rest and controlled phonation~Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises"
11357194|NCT03762993|BG001|Baseline|Healthy Adults Reporting Vocal Fatigue|"Participants will complete vocal rest and controlled phonation~Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises"
11357195|NCT03762993|BG002|Baseline|Total|Total of all reporting groups
11357196|NCT03762993|FG000|Participant Flow|Healthy Adults|"Participants will complete vocal rest and controlled phonation~Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises"
11357197|NCT03762993|FG001|Participant Flow|Healthy Adults Reporting Vocal Fatigue|"Participants will complete vocal rest and controlled phonation~Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises"
11357198|NCT03762993|OG000|Outcome|Healthy Adults|"Participants will complete vocal rest and controlled phonation~Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises"
11357199|NCT03762993|OG001|Outcome|Healthy Adults Reporting Vocal Fatigue|"Participants will complete vocal rest and controlled phonation~Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises"
11174129|NCT02019888|OG000|Outcome|Normal Hearing Adults|Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
11174130|NCT02019888|OG001|Outcome|Adults With Sensory Neural Hearing Loss|Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
11174131|NCT02019888|OG002|Outcome|Adults With Middle Ear Disorders|Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
11174132|NCT02019888|EG000|Reported Event|Normal Hearing Adults|Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
11174133|NCT02019888|EG001|Reported Event|Adults With Sensory Neural Hearing Loss|Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
11174134|NCT02019888|EG002|Reported Event|Adults With Middle Ear Disorders|Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
11174135|NCT02019927|BG000|Baseline|Non-arteritic Ischemic Optic Neuropathy|"Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174136|NCT02019927|BG001|Baseline|Non-arteritic Ischemic Optic Neuropathy Sham|Sham comparator for the Non-arteritic ischemic optic neuropathy group
11174137|NCT02019927|BG002|Baseline|Multiple Sclerosis|"Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174138|NCT02019927|BG003|Baseline|Multiple Sclerosis Sham|Sham comparator for the multiple sclerosis group
11174139|NCT02019927|BG004|Baseline|Ocular Trauma|"Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174140|NCT02019927|BG005|Baseline|Ocular Trauma Sham|Sham comparator for the ocular trauma group
11174141|NCT02019927|BG006|Baseline|Total|Total of all reporting groups
11174142|NCT02019927|FG000|Participant Flow|Non-arteritic Ischemic Optic Neuropathy|"Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174143|NCT02019927|FG001|Participant Flow|Non-arteritic Ischemic Optic Neuropathy (NAION) Sham|Sham treatment for Non-arteritic ischemic optic neuropathy group
11174144|NCT02019927|FG002|Participant Flow|Multiple Sclerosis|"Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174145|NCT02019927|FG003|Participant Flow|Multiple Sclerosis Sham|Sham treatment for optic neuritis with Multiple Sclerosis group
11174146|NCT02019927|FG004|Participant Flow|Ocular Trauma|"Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174147|NCT02019927|FG005|Participant Flow|Ocular Trauma Sham|Sham treatment for ocular trauma group
11174148|NCT02019927|OG000|Outcome|Non-arteritic Ischemic Optic Neuropathy|"Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11166811|NCT01975948|BG000|Baseline|Practice Support Program: Physician Sample|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
11166812|NCT01975948|BG001|Baseline|Treatment as Usual: Physician Sample|"Treatment as Usual for Depression~Depression Treatment as Usual: Physicians manage patients with depression as usual"
11166813|NCT01975948|BG002|Baseline|Practice Support Program: Patient Sample|"Patients of physicians trained in the Adult Mental Health Practice Support Program.~Inclusion criteria included >18 years of age, with a diagnosis of depression, PHQ-9 score of > 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician."
11166814|NCT01975948|BG003|Baseline|Treatment as Usual: Patient Sample|"Patients of physician who were randomized in the control group (TAU).~Inclusion criteria included >18 years of age, with a diagnosis of depression, PHQ-9 score of > 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician."
11166815|NCT01975948|BG004|Baseline|Total|Total of all reporting groups
11166816|NCT01975948|FG000|Participant Flow|Mental Health Practice Support Program;Physician Sample|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
11166817|NCT01975948|FG001|Participant Flow|Depression Treatment as Usual;Physician Sample|"Treatment as Usual for Depression~Depression Treatment as Usual: Physicians manage patients with depression as usual"
11166818|NCT01975948|FG002|Participant Flow|Mental Health Practice Support Program;Patient Sample|Patients were assigned to the same arm as their physician who were randomized to the Practice Support Program training. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015
11166819|NCT01975948|FG003|Participant Flow|Treatment as Usual: Patient Sample|Patients were assigned to the same arm as their physician, who were randomized to treating their patients as usual. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015
11166820|NCT01975948|OG000|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
11166821|NCT01975948|OG001|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
11166822|NCT01975948|OG000|Outcome|Mental Health PSP: Physicians|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
11166823|NCT01975948|OG001|Outcome|Treatment as Usual: Physicians|Depression Treatment as Usual: Physicians manage patients with depression as usual
11166824|NCT01975948|OG000|Outcome|Practice Support Program: Physician Sample|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
11166825|NCT01975948|OG001|Outcome|Treatment as Usual: Physician Sample|"Treatment as Usual for Depression~Depression Treatment as Usual: Physicians manage patients with depression as usual"
11166826|NCT01975948|EG000|Reported Event|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
11166827|NCT01975948|EG001|Reported Event|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
11166828|NCT01975974|BG000|Baseline|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
11166829|NCT01975974|FG000|Participant Flow|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
11166830|NCT01975974|OG000|Outcome|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
11166831|NCT01975974|EG000|Reported Event|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
11166832|NCT01976104|BG000|Baseline|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11351417|NCT03995784|BG000|Baseline|Overall Subjects|All subjects in the Safety Population received study treatment
11351418|NCT03995784|FG000|Participant Flow|Overall Subjects|Subjects were dosed with a single intravenous injection dose of 50 IU/kg coagulation Factor IX variant (CB2679d/Dalcinonacog alfa) and then daily subcutaneous doses of 100 IU/kg coagulation Factor IX variant (CB2679d/Dalcinonacog alfa) for 28 days
11351419|NCT03995784|OG000|Outcome|Overall Subjects|All subjects in the PK population
11166833|NCT01976104|BG001|Baseline|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
11166834|NCT01976104|BG002|Baseline|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11166835|NCT01976104|BG003|Baseline|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
11166836|NCT01976104|BG004|Baseline|Total|Total of all reporting groups
11166837|NCT01976104|FG000|Participant Flow|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 millilgrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11166838|NCT01976104|FG001|Participant Flow|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
11166839|NCT01976104|FG002|Participant Flow|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11166840|NCT01976104|FG003|Participant Flow|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
11166841|NCT01976104|OG000|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11166842|NCT01976104|OG001|Outcome|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
11166843|NCT01976104|OG002|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11166844|NCT01976104|OG003|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
11166845|NCT01976104|OG000|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11166846|NCT01976104|EG000|Reported Event|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11166847|NCT01976104|EG001|Reported Event|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
11166848|NCT01976104|EG002|Reported Event|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
11166849|NCT01976104|EG003|Reported Event|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
11166850|NCT01976299|BG000|Baseline|Active Treatment|"Standard of Care with the AVERT system~AVERT"
11166851|NCT01976299|BG001|Baseline|Standard of Care|
11166852|NCT01976299|BG002|Baseline|Total|Total of all reporting groups
11166853|NCT01976299|FG000|Participant Flow|Active Treatment|"Standard of Care with the AVERT system~AVERT"
11166854|NCT01976299|FG001|Participant Flow|Standard of Care|
11166855|NCT01976299|OG000|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
11166856|NCT01976299|OG001|Outcome|Standard of Care|
11166857|NCT01976299|EG000|Reported Event|Active Treatment|"Standard of Care with the AVERT system~AVERT"
11166858|NCT01976299|EG001|Reported Event|Standard of Care|
11166859|NCT01976312|BG000|Baseline|Ranibizumab 0.5 mg|PRN intravitreal injection
11166860|NCT01976312|BG001|Baseline|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
11166861|NCT01976312|BG002|Baseline|Total|Total of all reporting groups
11166862|NCT01976312|FG000|Participant Flow|Ranibizumab 0.5 mg|PRN intravitreal injection
11166863|NCT01976312|FG001|Participant Flow|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
11166864|NCT01976312|OG000|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
11166865|NCT01976312|OG001|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
11166866|NCT01976312|EG000|Reported Event|Ranibizumab 0.5 mg|PRN intravitreal injection
11166867|NCT01976312|EG001|Reported Event|Sham With Ranibizumab 0.5 mg|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
11166868|NCT01976312|EG002|Reported Event|Sham Without Ranibizumab 0.5 mg|Sham without Ranibizumab 0.5mg(hereafter referred to as sham group up to Month 3 and sham without ranibizumab after Month 3
11166869|NCT01976338|BG000|Baseline|Ranibizumab 0.5 mg|PRN Intravitreal injection
11166870|NCT01976338|BG001|Baseline|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
11166871|NCT01976338|BG002|Baseline|Total|Total of all reporting groups
11166872|NCT01976338|FG000|Participant Flow|Ranibizumab 0.5 mg|PRN Intravitreal injection
11166873|NCT01976338|FG001|Participant Flow|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
11166874|NCT01976338|OG000|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
11166875|NCT01976338|OG001|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
11166876|NCT01976338|EG000|Reported Event|Ranibizumab 0.5 mg|PRN Intravitreal injection
11166877|NCT01976338|EG001|Reported Event|Sham With Ranibizumab 0.5 mg|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
11166878|NCT01976338|EG002|Reported Event|Sham Without Ranibizumab 0.5 mg|sham + ranibizumab 0.5 mg PRN as of Month 6 (hereafter referred to as sham group up to Month 6 and sham with ranibizumab or sham without ranibizumab after Month 6)
11166879|NCT01976364|BG000|Baseline|Tofacitinib: All Participants|All enrolled participants with PsA who were part of a prior qualifying study, and received at least one dose of open-label study medication (tofacitinib) in this study.
11166880|NCT01976364|FG000|Participant Flow|Tofacitinib|Participants with active psoriatic arthritis (PsA) received tofacitinib 5 milligram (mg) oral tablet, twice daily (BID) with or without allowed concomitant disease-modifying anti-rheumatic drugs (DMARDs) examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
11166881|NCT01976364|FG001|Participant Flow|Tofacitinib 5 mg BID + Methotrexate (MTX)|Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
11166882|NCT01976364|FG002|Participant Flow|Tofacitinib 5 mg BID + Placebo|Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
11166883|NCT01976364|OG000|Outcome|All Participants|Main Study: Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Participants from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.
11166884|NCT01976364|OG000|Outcome|Tofacitinib 5 mg BID + Methotrexate (MTX)|Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
11166885|NCT01976364|OG001|Outcome|Tofacitinib 5 mg BID + Placebo|Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
11166886|NCT01976364|OG000|Outcome|Tofacitinib|Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
11166887|NCT01976364|EG000|Reported Event|All Tofacitinib|Main Study: Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Participants from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.
11166888|NCT01976364|EG001|Reported Event|Tofacitinib 5 mg BID + Methotrexate (MTX)|Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
11166889|NCT01976364|EG002|Reported Event|Tofacitinib 5 mg BID + Placebo|Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
11166890|NCT01976390|BG000|Baseline|Zortress (Everolimus)|"Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.~Everolimus: 0.75mg twice a day, Orally, starting on day of transplant"
11166891|NCT01976390|BG001|Baseline|Rapamune (Sirolimus)|"Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.~Sirolimus: 5mg, Orally, starting on day of transplant; decreasing to 3mg"
11166892|NCT01976390|BG002|Baseline|Total|Total of all reporting groups
11166893|NCT01976390|FG000|Participant Flow|Zortress (Everolimus)|"Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.~Everolimus: 0.75mg twice a day, Orally, starting on day of transplant"
11166894|NCT01976390|FG001|Participant Flow|Rapamune (Sirolimus)|"Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.~Sirolimus: 5mg, Orally, starting on day of transplant; decreasing to 3mg"
11166895|NCT01976390|OG000|Outcome|Zortress (Everolimus)|"Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.~Everolimus: 0.75mg twice a day, Orally, starting on day of transplant"
11166896|NCT01976390|OG001|Outcome|Rapamune (Sirolimus)|"Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.~Sirolimus: 5mg, Orally, starting on day of transplant; decreasing to 3mg"
11166897|NCT01976390|EG000|Reported Event|Zortress (Everolimus)|"Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.~Everolimus: 0.75mg twice a day, Orally, starting on day of transplant"
11166898|NCT01976390|EG001|Reported Event|Rapamune (Sirolimus)|"Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.~Sirolimus: 5mg, Orally, starting on day of transplant; decreasing to 3mg"
11166899|NCT01976416|BG000|Baseline|Hydroxyurea|"Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months~Hydroxyurea"
11166900|NCT01976416|BG001|Baseline|Placebo|"Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months~Placebo"
11166901|NCT01976416|BG002|Baseline|Total|Total of all reporting groups
11166902|NCT01976416|FG000|Participant Flow|Hydroxyurea|"Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months~Hydroxyurea"
11166903|NCT01976416|FG001|Participant Flow|Placebo|"Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months~Placebo"
11166904|NCT01976416|OG000|Outcome|Hydroxyurea|"Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months~Hydroxyurea"
11166905|NCT01976416|OG001|Outcome|Placebo|"Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months~Placebo"
11166906|NCT01976416|EG000|Reported Event|Hydroxyurea|"Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months~Hydroxyurea"
11166907|NCT01976416|EG001|Reported Event|Placebo|"Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months~Placebo"
11166908|NCT01976442|BG000|Baseline|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
11166909|NCT01976442|BG001|Baseline|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
11166910|NCT01976442|BG002|Baseline|Total|Total of all reporting groups
11166911|NCT01976442|FG000|Participant Flow|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
11166912|NCT01976442|FG001|Participant Flow|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
11166913|NCT01976442|OG000|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
11166914|NCT01976442|OG001|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
11166915|NCT01976442|EG000|Reported Event|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
11166916|NCT01976442|EG001|Reported Event|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
11166917|NCT01976507|BG000|Baseline|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
11166918|NCT01976507|FG000|Participant Flow|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
11166919|NCT01976507|OG000|Outcome|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
11166920|NCT01976507|EG000|Reported Event|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
11166921|NCT01976572|BG000|Baseline|All Subjects|
11166922|NCT01976572|FG000|Participant Flow|Treatment A|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, the first daily dose of colestilan (5 g) and candesartan were administered together (T0). On Day 13, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan, and on Day 19 at 3 hours after (T+3) the first daily dose of colestilan.
11166923|NCT01976572|FG001|Participant Flow|Treatment B|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan. On Day 13, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan, and on Day 19, the first daily dose of colestilan and candesartan were administered together (T0).
11166924|NCT01976572|FG002|Participant Flow|Treatment C|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan. On Day 13, the first daily dose of colestilan and candesartan was administered together (T0), and on Day 19 candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan.
11166925|NCT01976572|OG000|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
11166926|NCT01976572|OG001|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
11166927|NCT01976572|OG002|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
11166928|NCT01976572|OG003|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
11166929|NCT01976572|EG000|Reported Event|Candesartan Alone (Day 1 to 2)|
11166930|NCT01976572|EG001|Reported Event|Colestilan Alone (Day 3 to 6)|
11166931|NCT01976572|EG002|Reported Event|Candesartan Plus Colestilan (Day 7 to 24)|
11166932|NCT01976624|BG000|Baseline|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
11166933|NCT01976624|FG000|Participant Flow|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
11166934|NCT01976624|OG000|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
11166935|NCT01976624|EG000|Reported Event|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
11166936|NCT01976650|BG000|Baseline|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
11166937|NCT01976650|FG000|Participant Flow|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
11166938|NCT01976650|OG000|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
11166939|NCT01976650|EG000|Reported Event|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
11166940|NCT01976663|BG000|Baseline|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
11166941|NCT01976663|FG000|Participant Flow|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
11166942|NCT01976663|OG000|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
11166943|NCT01976663|OG001|Outcome|Control|Nasolabial folds treated with Control.
11166944|NCT01976663|EG000|Reported Event|JUVEDERM VOLIFT® XC During Initial/Touch Up|Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Initial/Touch Up period.
11166945|NCT01976663|EG001|Reported Event|Control During Initial/Touch Up Treatment Period|Nasolabial folds treated with Control during the Initial/Touch Up period.
11166946|NCT01976663|EG002|Reported Event|Not at NLF During Initial/Touch Up Treatment Period|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
11166947|NCT01976663|EG003|Reported Event|JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment|Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Asymmetry Correction/Repeat Treatment period.
11166948|NCT01976728|BG000|Baseline|LutrePulse 10 µg/Pulse|Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
11166949|NCT01976728|BG001|Baseline|LutrePulse 15 µg/Pulse|Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
11166950|NCT01976728|BG002|Baseline|LutrePulse 20 µg/Pulse|Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
11166951|NCT01976728|BG003|Baseline|Placebo|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
11166952|NCT01976728|BG004|Baseline|Total|Total of all reporting groups
11166953|NCT01976728|FG000|Participant Flow|LutrePulse 10 µg/Pulse|Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump
11166954|NCT01976728|FG001|Participant Flow|LutrePulse 15 µg/Pulse|Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
11166955|NCT01976728|FG002|Participant Flow|LutrePulse 20 µg/Pulse|Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
11166956|NCT01976728|FG003|Participant Flow|Placebo|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
11166957|NCT01976728|OG000|Outcome|LutrePulse 10 µg/Pulse|Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
11166958|NCT01976728|OG001|Outcome|LutrePulse 15 µg/Pulse|Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
11166959|NCT01976728|OG002|Outcome|LutrePulse 20 µg/Pulse|Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
11166960|NCT01976728|OG003|Outcome|Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled|Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
11166961|NCT01976728|OG004|Outcome|Placebo|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
11166962|NCT01976728|OG000|Outcome|LutrePulse 10 µg/Pulse|Gonadorelin acetate SC 10 µg/pulse as a fixed dose, administered via. OmniPod pump
11166963|NCT01976728|OG001|Outcome|LutrePulse 15 µg/Pulse|Gonadorelin acetate SC 15 µg/pulse as a fixed dose, administered via. OmniPod pump
11166964|NCT01976728|OG002|Outcome|LutrePulse 20 µg/Pulse|Gonadorelin acetate SC 20 µg/pulse as a fixed dose, administered via. OmniPod pump
11166965|NCT01976728|OG003|Outcome|Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled|Gonadorelin acetate SC 15 μg/pulse and 20 μg/pulse, administered via. OmniPod pump pooled
11166966|NCT01976728|OG001|Outcome|LutrePulse 15 µg/Pulse|Gonadorelin acetate SC 15 µg/pulse as fixed dose, administered via. OmniPod pump
11166967|NCT01976728|OG003|Outcome|Placebo|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump
11166968|NCT01976728|OG003|Outcome|Placebo|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
11166969|NCT01976728|OG000|Outcome|LutrePulse 10 µg/Pulse|Gonadorelin acetate SC 10 µg/pulse as a fixed dose, administered via. OmniPod
11166970|NCT01976728|OG001|Outcome|LutrePulse 15 µg/Pulse|Gonadorelin acetate SC 15 µg/pulse as a fixed dose, administered via. OmniPod
11166971|NCT01976728|OG002|Outcome|LutrePulse 20 µg/Pulse|Gonadorelin acetate SC 20 µg/pulse as a fixed dose, administered via. OmniPod
11166972|NCT01976728|OG003|Outcome|Placebo|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod)
11166973|NCT01976728|OG002|Outcome|LutrePulse 20 µg/Pulse|Gonadorelin acetate SC 20 µg/pulse as a fixed dose, , administered via. OmniPod
11229797|NCT02401464|FG000|Participant Flow|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
11229798|NCT02401464|FG001|Participant Flow|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
11229799|NCT02401464|FG002|Participant Flow|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
11229800|NCT02401464|FG003|Participant Flow|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
11229801|NCT02401464|OG000|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
11229802|NCT02401464|OG001|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
11229803|NCT02401464|OG000|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
11229804|NCT02401464|OG001|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
11229805|NCT02401464|OG002|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
11229806|NCT02401464|OG003|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
11229807|NCT02401464|EG000|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
11229808|NCT02401464|EG001|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
11229809|NCT02401464|EG002|Reported Event|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
11229810|NCT02401464|EG003|Reported Event|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
11229811|NCT02401529|BG000|Baseline|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
11229812|NCT02401529|BG001|Baseline|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
11229813|NCT02401529|BG002|Baseline|Total|Total of all reporting groups
10887854|NCT00503308|EG000|Reported Event|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2-5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
11229814|NCT02401529|FG000|Participant Flow|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
11229815|NCT02401529|FG001|Participant Flow|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
11229816|NCT02401529|OG000|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
11229817|NCT02401529|OG001|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
11229818|NCT02401529|OG000|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~Number of participants when started 59"
11351420|NCT03995784|OG000|Outcome|Actual Value (%)|Actual Values of FIX activity levels during study
11166974|NCT01976728|OG000|Outcome|LutrePulse 10 µg/Pulse|Gonadorelin acetate SC 10 µg/pulse as fixed dose, administered via. OmniPod pump
11166975|NCT01976728|OG002|Outcome|LutrePulse 20 µg/Pulse|Gonadorelin acetate SC 20 µg/pulse as fixed dose, administered via. OmniPod pump
11166976|NCT01976728|OG003|Outcome|Placebo|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, , administered via. OmniPod pump)
11166977|NCT01976728|EG000|Reported Event|LutrePulse 10 µg/Pulse|Gonadorelin acetate SC 10 µg/pulse as a fixed dose, administered via. OmniPod pump
11166978|NCT01976728|EG001|Reported Event|LutrePulse 15 µg/Pulse|Gonadorelin acetate SC 15 µg/pulse as a fixed dose, administered via. OmniPod pump
11166979|NCT01976728|EG002|Reported Event|LutrePulse 20 µg/Pulse|Gonadorelin acetate SC 20 µg/pulse as a fixed dose, administered via. OmniPod pump
11166980|NCT01976728|EG003|Reported Event|Placebo|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
11166981|NCT01976741|BG000|Baseline|Rogaratinib 50 mg BID|Participants received Rogaratinib as a single dose of 50 mg solution on C1D1 and 50 mg solution BID (in total 100 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166982|NCT01976741|BG001|Baseline|Rogaratinib 100 mg BID|Participants received a single dose of 100 mg Rogaratinib tablet formulation on C1D-3, followed by a single dose of 100 mg solution on C1D1 and continued with 100 mg BID of solution (in total 200 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166983|NCT01976741|BG002|Baseline|Rogaratinib 200 mg BID|Participants received Rogaratinib as a single dose of 200 mg tablet on C1D1 and 200 mg tablet BID (in total 400 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166984|NCT01976741|BG003|Baseline|Rogaratinib 400 mg BID|Participants received Rogaratinib as a single dose of 400 mg tablet on C1D1 and 400 mg tablet BID (in total 800 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166985|NCT01976741|BG004|Baseline|Rogaratinib 600 mg BID|Participants received Rogaratinib as a single dose of 600 mg tablet on C1D1 and 600 mg tablet BID (in total 1200 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166986|NCT01976741|BG005|Baseline|Rogaratinib 800 mg BID|Participants received Rogaratinib as a single dose of 800 mg tablet on C1D1 and 800 mg tablet BID (in total 1600 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166987|NCT01976741|BG006|Baseline|Rogaratinib Dose Expansion (All Comers)|Participants with cancer types other than bladder cancer (BC), squamous cell carcinoma of the head and neck (SCCHN), and squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11166988|NCT01976741|BG007|Baseline|Rogaratinib Dose Expansion (BC)|Participants with bladder cancer (BC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11166989|NCT01976741|BG008|Baseline|Rogaratinib Dose Expansion (SCCHN)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11166990|NCT01976741|BG009|Baseline|Rogaratinib Dose Expansion (sqNSCLC)|Participants with squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11166991|NCT01976741|BG010|Baseline|Total|Total of all reporting groups
11166992|NCT01976741|FG000|Participant Flow|Rogaratinib 50 mg BID|Participants received Rogaratinib as a single dose of 50 mg solution on C1D1 and 50 mg solution BID (in total 100 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166993|NCT01976741|FG001|Participant Flow|Rogaratinib 100 mg BID|Participants received a single dose of 100 mg Rogaratinib tablet formulation on C1D-3, followed by a single dose of 100 mg solution on C1D1 and continued with 100 mg BID of solution (in total 200 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166994|NCT01976741|FG002|Participant Flow|Rogaratinib 200 mg BID|Participants received Rogaratinib as a single dose of 200 mg tablet on C1D1 and 200 mg tablet BID (in total 400 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166995|NCT01976741|FG003|Participant Flow|Rogaratinib 400 mg BID|Participants received Rogaratinib as a single dose of 400 mg tablet on C1D1 and 400 mg tablet BID (in total 800 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166996|NCT01976741|FG004|Participant Flow|Rogaratinib 600 mg BID|Participants received Rogaratinib as a single dose of 600 mg tablet on C1D1 and 600 mg tablet BID (in total 1200 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166997|NCT01976741|FG005|Participant Flow|Rogaratinib 800 mg BID|Participants received Rogaratinib as a single dose of 800 mg tablet on C1D1 and 800 mg tablet BID (in total 1600 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11166998|NCT01976741|FG006|Participant Flow|Rogaratinib Dose Expansion (All Comers)|Participants with cancer types other than bladder cancer (BC), squamous cell carcinoma of the head and neck (SCCHN), and squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11166999|NCT01976741|FG007|Participant Flow|Rogaratinib Dose Expansion (BC)|Participants with bladder cancer (BC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167000|NCT01976741|FG008|Participant Flow|Rogaratinib Dose Expansion (SCCHN)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167001|NCT01976741|FG009|Participant Flow|Rogaratinib Dose Expansion (sqNSCLC)|Participants with squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167002|NCT01976741|OG000|Outcome|Rogaratinib Total Dose Escalation|Participants with any type of solid tumor received escalating doses of Rogaratinib oral solution or tablet. The actual dose-escalation cohorts were 100 mg (50 mg BID), 200 mg (100 mg BID), 400 mg (200 mg BID), 800 mg (400 mg BID), 1200 mg (600 mg BID), and 1600 mg (800 mg BID). The participants in the 100 mg and 200 mg dose-escalation cohorts received oral solution and the participants in all the subsequent dose-escalation cohorts received tablet. And as an exception, on C1D-3 in the 200 mg dose-escalation cohort, the participants received tablet instead of oral solution.
11167003|NCT01976741|OG000|Outcome|Rogaratinib 100 mg BID|Participants received a single dose of 100 mg Rogaratinib tablet formulation on C1D-3, followed by a single dose of 100 mg solution on C1D1 and continued with 100 mg BID of solution (in total 200 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11167004|NCT01976741|OG001|Outcome|Rogaratinib Expansion Food Effect|For food effect assessment, participants in the MTD expansion cohorts (1600 mg) of study Part 1 and Part 2 received single doses (800 mg) of the study drug on C1D-3 (after consumption of a high-fat, high-calorie breakfast) and on C1D1 (after an overnight fast of at least 8 h). The participants continued with 800 mg BID doses of the study drug from C1D3 onward.
11167005|NCT01976741|OG000|Outcome|Rogaratinib 50 mg BID|Participants received Rogaratinib as a single dose of 50 mg solution on C1D1 and 50 mg solution BID (in total 100 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11167006|NCT01976741|OG001|Outcome|Rogaratinib 100 mg BID|Participants received a single dose of 100 mg Rogaratinib tablet formulation on C1D-3, followed by a single dose of 100 mg solution on C1D1 and continued with 100 mg BID of solution (in total 200 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11167007|NCT01976741|OG002|Outcome|Rogaratinib 200 mg BID|Participants received Rogaratinib as a single dose of 200 mg tablet on C1D1 and 200 mg tablet BID (in total 400 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11167008|NCT01976741|OG003|Outcome|Rogaratinib 400 mg BID|Participants received Rogaratinib as a single dose of 400 mg tablet on C1D1 and 400 mg tablet BID (in total 800 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11167009|NCT01976741|OG004|Outcome|Rogaratinib 600 mg BID|Participants received Rogaratinib as a single dose of 600 mg tablet on C1D1 and 600 mg tablet BID (in total 1200 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11167010|NCT01976741|OG005|Outcome|Rogaratinib 800 mg BID|Participants received Rogaratinib as a single dose of 800 mg tablet on C1D1 and 800 mg tablet BID (in total 1600 mg) from C1D3 ongoing in 21-days cycles in dose escalation phase.
11167011|NCT01976741|OG006|Outcome|Rogaratinib 800 mg BID Pooled|Participants received Rogaratinib 800 mg tablet BID (in total 1600 mg) in dose escalation phase and MTD expansion phase.
11167012|NCT01976741|OG007|Outcome|Rogaratinib Expansion Food Effect|For food effect assessment, participants in the MTD expansion cohorts (1600 mg) of study Part 1 and Part 2 received single doses (800 mg) of the study drug on C1D-3 (after consumption of a high-fat, high-calorie breakfast) and on C1D1 (after an overnight fast of at least 8 h). The participants continued with 800 mg BID doses of the study drug from C1D3 onward.
11167013|NCT01976741|OG008|Outcome|Rogaratinib Dose Expansion (All Comers)|Participants with cancer types other than bladder cancer (BC), squamous cell carcinoma of the head and neck (SCCHN), and squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167014|NCT01976741|OG009|Outcome|Rogaratinib Dose Expansion (BC)|Participants with bladder cancer (BC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167015|NCT01976741|OG010|Outcome|Rogaratinib Dose Expansion (SCCHN)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167016|NCT01976741|OG011|Outcome|Rogaratinib Dose Expansion (sqNSCLC)|Participants with squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167017|NCT01976741|OG008|Outcome|Rogaratinib Dose Expansion (All Comers)|Participants with cancer types other than bladder cancer (BC), squamous cell carcinoma of the head and neck (SCCHN), and squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21- days cycles.
11167018|NCT01976741|OG000|Outcome|Rogaratinib 800 mg BID Pooled|Participants received Rogaratinib 800 mg tablet BID (in total 1600 mg) in dose escalation phase and MTD expansion phase.
11167019|NCT01976741|OG001|Outcome|Rogaratinib Dose Expansion (All Comers)|Participants with cancer types other than bladder cancer (BC), squamous cell carcinoma of the head and neck (SCCHN), and squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167020|NCT01976741|OG002|Outcome|Rogaratinib Dose Expansion (BC)|Participants with bladder cancer (BC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167021|NCT01976741|OG003|Outcome|Rogaratinib Dose Expansion (SCCHN)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167022|NCT01976741|OG004|Outcome|Rogaratinib Dose Expansion (sqNSCLC)|Participants with squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167023|NCT01976741|OG000|Outcome|Rogaratinib Dose Expansion (All Comers)|Participants with cancer types other than bladder cancer (BC), squamous cell carcinoma of the head and neck (SCCHN), and squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167024|NCT01976741|OG001|Outcome|Rogaratinib Dose Expansion (BC)|Participants with bladder cancer (BC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167025|NCT01976741|OG002|Outcome|Rogaratinib Dose Expansion (SCCHN)|Participants with squamous cell carcinoma of the head and neck (SCCHN) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167026|NCT01976741|OG003|Outcome|Rogaratinib Dose Expansion (sqNSCLC)|Participants with squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167027|NCT01976741|OG005|Outcome|Rogaratinib 800 mg BID|Participants received Rogaratinib as a single dose of 800 mg tablet on C1D1 and 800 mg tablet BID (in total 1600 mg) from C1D3 ongoing in a 21-days Cycle in dose escalation phase.
11167028|NCT01976741|OG006|Outcome|Rogaratinib Dose Expansion|All participants from MTD expansion cohorts.
11174149|NCT02019927|OG001|Outcome|Sham - Non-arteritic Ischemic Optic Neuropathy|Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
11351421|NCT03995784|OG001|Outcome|Change From Baseline (%)|Change from Baseline in values of FIX activity levels during study
11351422|NCT03995784|OG000|Outcome|Area Under the Curve (AUC)|Observations of mean PK parameters
11229819|NCT02401529|EG000|Reported Event|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
11229820|NCT02401529|EG001|Reported Event|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
11229821|NCT02401542|BG000|Baseline|Vofatamab Plus Docetaxel|"IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.~Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor.~Vofatamab~Docetaxel"
11229822|NCT02401542|BG001|Baseline|Vofatamab|"IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.~Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination.~Vofatamab"
11229823|NCT02401542|BG002|Baseline|Placebo Plus Docetaxel|"IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle.~One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor~Docetaxel~Placebo"
11229824|NCT02401542|BG003|Baseline|Total|Total of all reporting groups
11229825|NCT02401542|FG000|Participant Flow|Vofatamab Plus Docetaxel|"IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.~Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor.~Vofatamab~Docetaxel"
11229826|NCT02401542|FG001|Participant Flow|Vofatamab|"IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.~Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination.~Vofatamab"
11229827|NCT02401542|FG002|Participant Flow|Placebo Plus Docetaxel|"IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle.~One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor~Docetaxel~Placebo"
11229828|NCT02401542|OG000|Outcome|Mut/Fus Phase 1|Vofatamab plus Docetaxel
11229829|NCT02401542|OG001|Outcome|Wild Type Phase 1|Vofatamab plus Docetaxel
11229830|NCT02401542|OG002|Outcome|Mut/Fus Phase 2|Vofatamab plus Docetaxel
11229831|NCT02401542|OG003|Outcome|Mut/Fus Phase 2 Monotherapy|Vofatamab Monotherpay
11229832|NCT02401542|OG004|Outcome|Mut/Fus Phase 2b Monotherapy|Vofatamab Monotherapy
11229833|NCT02401542|EG000|Reported Event|Vofatamab Plus Docetaxel|"IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.~Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor.~Vofatamab~Docetaxel"
11229834|NCT02401542|EG001|Reported Event|Vofatamab|"IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.~Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination.~Vofatamab"
11229835|NCT02401542|EG002|Reported Event|Placebo Plus Docetaxel|"IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle.~One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor~Docetaxel~Placebo"
11229836|NCT02401555|BG000|Baseline|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229837|NCT02401555|BG001|Baseline|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229838|NCT02401555|BG002|Baseline|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229839|NCT02401555|BG003|Baseline|Total|Total of all reporting groups
11351423|NCT03995784|OG000|Outcome|Value|Observations of mean PK parameters
11351424|NCT03995784|OG000|Outcome|Overall Safety Population|All subjects in the Safety Population received study treatment
11229840|NCT02401555|FG000|Participant Flow|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229841|NCT02401555|FG001|Participant Flow|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229842|NCT02401555|FG002|Participant Flow|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229843|NCT02401555|OG000|Outcome|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229844|NCT02401555|OG001|Outcome|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229845|NCT02401555|OG002|Outcome|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229846|NCT02401555|EG000|Reported Event|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229847|NCT02401555|EG001|Reported Event|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229848|NCT02401555|EG002|Reported Event|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
11229849|NCT02401672|BG000|Baseline|Active TMS|"Repetitive TMS pulse stimulation~Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS)."
11229850|NCT02401672|BG001|Baseline|Sham TMS|"The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.~Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS)."
11229851|NCT02401672|BG002|Baseline|Total|Total of all reporting groups
11229852|NCT02401672|FG000|Participant Flow|Active TMS|"Repetitive TMS pulse stimulation~Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS)."
11229853|NCT02401672|FG001|Participant Flow|Sham TMS|"The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.~Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS)."
11233927|NCT02431559|OG000|Outcome|Phase 1, Dose Level 0a|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W [equivalent to 450 mg Q4W] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
11229854|NCT02401672|OG000|Outcome|Active TMS|"Repetitive TMS pulse stimulation~Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS)."
11229855|NCT02401672|OG001|Outcome|Sham TMS|"The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.~Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS)."
11229856|NCT02401672|EG000|Reported Event|Active TMS|"Repetitive TMS pulse stimulation~Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS)."
11229857|NCT02401672|EG001|Reported Event|Sham TMS|"The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.~Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS)."
11229858|NCT02401867|BG000|Baseline|Full Sample|Descriptive characteristics for the full sample (n=150).
11229859|NCT02401867|FG000|Participant Flow|Overall Sample|Overall sample reported as all participants received both the self and the provider swab.
11229860|NCT02401867|OG000|Outcome|Participants With Positive Cervical HPV DNA Test Result|Positive result determined by reference test: provider cervical HPV DNA Hybridization assay
11229861|NCT02401867|OG001|Outcome|Participants With a Negative Cervical HPV DNA Test Result|Negative result determined by reference test: provider cervical HPV DNA Hybridization assay
11229862|NCT02401867|EG000|Reported Event|Full Sample|Descriptive characteristics for the full sample (n=150).
11229863|NCT02402062|BG000|Baseline|TH-302 + Sunitinib|"TH-302 + Sunitinib. Single arm Study.~TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:~Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.~TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle."
11229864|NCT02402062|FG000|Participant Flow|TH-302 + Sunitinib|"TH-302 + Sunitinib. Single arm Study.~TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:~Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.~TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle."
11229865|NCT02402062|OG000|Outcome|TH-302 + Sunitinib|"TH-302 + Sunitinib. Single arm Study.~TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:~Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.~TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle."
11229866|NCT02402062|EG000|Reported Event|TH-302 + Sunitinib|"TH-302 + Sunitinib. Single arm Study.~TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:~Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.~TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle."
11229867|NCT02402127|BG000|Baseline|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
11229868|NCT02402127|BG001|Baseline|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
11229869|NCT02402127|BG002|Baseline|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
11229870|NCT02402127|BG003|Baseline|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
11229871|NCT02402127|BG004|Baseline|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
11229872|NCT02402127|BG005|Baseline|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
11229873|NCT02402127|BG006|Baseline|Total|Total of all reporting groups
11229874|NCT02402127|FG000|Participant Flow|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
11229875|NCT02402127|FG001|Participant Flow|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
11229876|NCT02402127|FG002|Participant Flow|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
11229877|NCT02402127|FG003|Participant Flow|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
11351425|NCT03995784|OG000|Outcome|Actual Value|Actual Values during study
11229878|NCT02402127|FG004|Participant Flow|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
11229879|NCT02402127|FG005|Participant Flow|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
11229880|NCT02402127|OG000|Outcome|TruEye|Narafilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
11229881|NCT02402127|OG001|Outcome|MyDay|Stenfilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
11229882|NCT02402127|OG002|Outcome|Clariti 1day|Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
11229883|NCT02402127|OG000|Outcome|TruEye|Narafilcon A contact lenses
11229884|NCT02402127|OG001|Outcome|MyDay|Stenfilcon A contact lenses
11229885|NCT02402127|OG002|Outcome|Clariti 1day|Somofilcon A contact lenses
11229886|NCT02402127|EG000|Reported Event|TruEye|Narafilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
11229887|NCT02402127|EG001|Reported Event|MyDay|Stenfilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
11229888|NCT02402127|EG002|Reported Event|Clariti 1day|Somofilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
11229889|NCT02402153|BG000|Baseline|Sydvestjysk Hospital|"Observational EEG recording with the Hyposafe device~Hyposafe device: Subcutaneous EEG recorder for EEG measurements"
11229890|NCT02402153|FG000|Participant Flow|Sydvestjysk Hospital|"Observational EEG recording with the Hyposafe device~Hyposafe device: Subcutaneous EEG recorder for EEG measurements"
11229891|NCT02402153|OG000|Outcome|Sydvestjysk Hospital|"Observational EEG recording with the Hyposafe device~Hyposafe device: Subcutaneous EEG recorder for EEG measurements"
11229892|NCT02402153|EG000|Reported Event|Sydvestjysk Hospital|"Observational EEG recording with the Hyposafe device~Hyposafe device: Subcutaneous EEG recorder for EEG measurements"
11229893|NCT02402166|BG000|Baseline|SPD489|Participants received 5 milligram (mg) capsule of SPD489 orally once daily and titrated up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 8 weeks.
11229894|NCT02402166|FG000|Participant Flow|SPD489|Participants received 5 milligram (mg) capsule of SPD489 orally once daily and titrated up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 8 weeks.
11229895|NCT02402166|OG000|Outcome|SPD489 5 mg|Participants received 5 mg capsule of SPD489 orally once daily from Week 1 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229896|NCT02402166|OG001|Outcome|SPD489 10 mg|Participants received 10 mg capsule of SPD489 orally once daily from Week 2 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229897|NCT02402166|OG002|Outcome|SPD489 15 mg|Participants received 15 mg capsule of SPD489 orally once daily from Week 3 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229898|NCT02402166|OG003|Outcome|SPD489 20 mg|Participants received 20 mg capsule of SPD489 orally once daily from Week 4 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229899|NCT02402166|OG004|Outcome|SPD489 30 mg|Participants received 30 mg capsule of SPD489 orally once daily from Week 5 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229900|NCT02402166|OG005|Outcome|SPD489|Participants received 5 mg capsule of SPD489 orally once daily and titrated up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 8 weeks.
11229901|NCT02402166|OG000|Outcome|SPD489|Participants received 5 milligram (mg) capsule of SPD489 orally once daily and titrated up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 8 weeks.
11229902|NCT02402166|OG000|Outcome|SPD489 10 mg|Participants received 10 mg capsule of SPD489 orally once daily from Week 2 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229903|NCT02402166|OG001|Outcome|SPD489 15 mg|Participants received 15 mg capsule of SPD489 orally once daily from Week 3 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229904|NCT02402166|OG002|Outcome|SPD489 30 mg|Participants received 30 mg capsule of SPD489 orally once daily from Week 5 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229905|NCT02402166|EG000|Reported Event|SPD489 5mg|Participants received 5 mg capsule of SPD489 orally once daily from Week 1 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229906|NCT02402166|EG001|Reported Event|SPD489 10mg|Participants received 10 mg capsule of SPD489 orally once daily from Week 2 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229907|NCT02402166|EG002|Reported Event|SPD489 15mg|Participants received 15 mg capsule of SPD489 orally once daily from Week 3 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229908|NCT02402166|EG003|Reported Event|SPD489 20mg|Participants received 20 mg capsule of SPD489 orally once daily from Week 4 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229909|NCT02402166|EG004|Reported Event|SPD489 30mg|Participants received 30 mg capsule of SPD489 orally once daily from Week 5 up to Week 8 based on the investigator's assessment of participants' response and tolerability.
11229910|NCT02402166|EG005|Reported Event|SPD489|Participants received 5 mg capsule of SPD489 orally once daily and titrated up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 8 weeks.
11229911|NCT02402218|BG000|Baseline|Usual Care|"Participants receive standard of care for Hepatitis C in the clinic.~Usual Care: Participants receive standard of care in the clinic from their health care team."
11229912|NCT02402218|BG001|Baseline|Usual Care Plus Peer-mentors|"In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.~Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni."
11351426|NCT03995784|OG001|Outcome|Change From Baseline|Change from Baseline in values during study
11229913|NCT02402218|BG002|Baseline|Usual Care Plus Incentives|"In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.~Usual care plus incentives: Participants are given incentives after completing treatment goals."
11229914|NCT02402218|BG003|Baseline|Total|Total of all reporting groups
11229915|NCT02402218|FG000|Participant Flow|Usual Care|"Participants receive standard of care for Hepatitis C in the clinic.~Usual Care: Participants receive standard of care in the clinic from their health care team."
11229916|NCT02402218|FG001|Participant Flow|Usual Care Plus Peer-mentors|"In addition to receiving standard of care for hepatitis C virus (HCV) in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.~Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni."
11229917|NCT02402218|FG002|Participant Flow|Usual Care Plus Incentives|"In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.~Usual care plus incentives: Participants are given incentives after completing treatment goals."
11229918|NCT02402218|OG000|Outcome|Usual Care|"Participants receive standard of care for Hepatitis C in the clinic.~Usual Care: Participants receive standard of care in the clinic from their health care team."
11229919|NCT02402218|OG001|Outcome|Usual Care Plus Peer-mentors|"In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.~Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni."
11229920|NCT02402218|OG002|Outcome|Usual Care Plus Incentives|"In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.~Usual care plus incentives: Participants are given incentives after completing treatment goals."
11229921|NCT02402218|EG000|Reported Event|Usual Care With LDV/SOF|"Participants receive standard of care for Hepatitis C in the clinic.~Usual Care: Participants receive standard of care in the clinic from their health care team. This group of patients initiated treatment with LDV/SOF."
11229922|NCT02402218|EG001|Reported Event|Usual Care Plus Peer-mentors With LDV/SOF|"In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.~Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with LDV/SOF. This group of patients initiated treatment with LDV/SOF."
11229923|NCT02402218|EG002|Reported Event|Usual Care Plus Incentives With LDV/SOF|"In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.~Usual care plus incentives: Participants are given incentives after completing treatment goals. This group of patients initiated treatment with LDV/SOF."
11229924|NCT02402296|BG000|Baseline|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
11229925|NCT02402296|BG001|Baseline|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
11229926|NCT02402296|BG002|Baseline|Total|Total of all reporting groups
11229927|NCT02402296|FG000|Participant Flow|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
11229928|NCT02402296|FG001|Participant Flow|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
11229929|NCT02402296|OG000|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
11229930|NCT02402296|OG001|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
11351427|NCT03995784|EG000|Reported Event|Overall Subjects|All subjects in the Safety Population received study treatment
11357200|NCT03762993|EG000|Reported Event|Healthy Adults|"Participants will complete vocal rest and controlled phonation~Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises"
11229931|NCT02402296|EG000|Reported Event|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
11229932|NCT02402296|EG001|Reported Event|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
11229933|NCT02402322|BG000|Baseline|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
11229934|NCT02402322|BG001|Baseline|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
11229935|NCT02402322|BG002|Baseline|Waiting List|Participants in a waiting list.
11229936|NCT02402322|BG003|Baseline|Total|Total of all reporting groups
11229937|NCT02402322|FG000|Participant Flow|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
11229938|NCT02402322|FG001|Participant Flow|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
11229939|NCT02402322|FG002|Participant Flow|Waiting List|Participants in a waiting list.
11229940|NCT02402322|OG000|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
11229941|NCT02402322|OG001|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
11229942|NCT02402322|OG002|Outcome|Waiting List|Participants in a waiting list.
11229943|NCT02402322|EG000|Reported Event|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
11229944|NCT02402322|EG001|Reported Event|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
11229945|NCT02402322|EG002|Reported Event|Waiting List|Participants in a waiting list.
11229946|NCT02402452|BG000|Baseline|Severe Renal Impairment|Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229947|NCT02402452|BG001|Baseline|Normal Renal Function|Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
11229948|NCT02402452|BG002|Baseline|Total|Total of all reporting groups
11229949|NCT02402452|FG000|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229950|NCT02402452|FG001|Participant Flow|Normal Renal Function|Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
11229951|NCT02402452|OG000|Outcome|Severe Renal Impairment|Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229952|NCT02402452|OG001|Outcome|Normal Renal Function|Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
11229953|NCT02402452|EG000|Reported Event|Severe Renal Impairment|Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
11229954|NCT02402452|EG001|Reported Event|Normal Renal Function|Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
11229955|NCT02402764|BG000|Baseline|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
11229956|NCT02402764|FG000|Participant Flow|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
11229957|NCT02402764|OG000|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
11229958|NCT02402764|EG000|Reported Event|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
11229959|NCT02402881|BG000|Baseline|Intervention|"Patient Visits received the Patient-centered education bundle: A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.~This trial treats each visit as a separate enrollment and as a result it is only appropriate to consider the participant at the visit level. The outcomes assessed for this trial were analyzed on the patient visit level, as each visit represents a totally unique participant outcome. For example, Patient A might receive all doses during the first admission to the hospital but the same Patient A might miss doses during a second hospitalization. Similarly, Patient A might have been in Arm 1 during the first hospitalization and in Arm 2 during the second hospitalization."
11229960|NCT02402881|BG001|Baseline|Control|Patient Visits received the only the standard practices of care. This trial treats each visit as a separate enrollment and as a result it is only appropriate to consider the participant at the visit level. The outcomes assessed for this trial were analyzed on the patient visit level, as each visit represents a totally unique participant outcome. For example, Patient A might receive all doses during the first admission to the hospital but the same Patient A might miss doses during a second hospitalization. Similarly, Patient A might have been in Arm 1 during the first hospitalization and in Arm 2 during the second hospitalization.
11229961|NCT02402881|BG002|Baseline|Total|Total of all reporting groups
11229962|NCT02402881|FG000|Participant Flow|Intervention|Patient-centered education bundle: A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
11229963|NCT02402881|FG001|Participant Flow|Control|Patients will receive only the standard practices of care
11229964|NCT02402881|OG000|Outcome|Intervention|Patient-centered education bundle: A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
11229965|NCT02402881|OG001|Outcome|Control|Patients will receive only the standard practices of care.
11229966|NCT02402881|EG000|Reported Event|Intervention|Patient Visits received the Patient-centered education bundle: A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
11229967|NCT02402881|EG001|Reported Event|Control|Patient Visits received only the standard practices of care.
11229968|NCT02402907|BG000|Baseline|CHG Cloth|2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
11229969|NCT02402907|BG001|Baseline|Placebo Cloth|Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
11229970|NCT02402907|BG002|Baseline|Total|Total of all reporting groups
11229971|NCT02402907|FG000|Participant Flow|CHG Cloth|2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
11229972|NCT02402907|FG001|Participant Flow|Placebo Cloth|Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
11229973|NCT02402907|OG000|Outcome|CHG Cloth|2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
11229974|NCT02402907|OG001|Outcome|Placebo Cloth|Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
11229975|NCT02402907|EG000|Reported Event|CHG Cloth|2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
11229976|NCT02402907|EG001|Reported Event|Placebo Cloth|Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
11229977|NCT02402933|BG000|Baseline|Nasal Glucagon (NG)|Nasal glucagon 3 milligram (mg)
11229978|NCT02402933|FG000|Participant Flow|Nasal Glucagon (NG)|A single dose of 3 mg glucagon nasal powder administered using a nasal powder delivery device for the treatment of moderate or severe hypoglycemic events; a maximum of 4 events per participant during the study.
11229979|NCT02402933|OG000|Outcome|Nasal Glucagon|Nasal glucagon (NG) 3 mg
11229980|NCT02402933|EG000|Reported Event|Nasal Glucagon|3 mg glucagon powder
11229981|NCT02403180|BG000|Baseline|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2.
11229982|NCT02403180|BG001|Baseline|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2.
11229983|NCT02403180|BG002|Baseline|Total|Total of all reporting groups
11229984|NCT02403180|FG000|Participant Flow|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
11229985|NCT02403180|FG001|Participant Flow|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
11229986|NCT02403180|OG000|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
11229987|NCT02403180|OG001|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
11229988|NCT02403180|EG000|Reported Event|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
11229989|NCT02403180|EG001|Reported Event|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
11229990|NCT02403206|BG000|Baseline|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
11229991|NCT02403206|BG001|Baseline|Manual (CCC)|CCC performed during cataract surgery
11229992|NCT02403206|BG002|Baseline|Total|Total of all reporting groups
11229993|NCT02403206|FG000|Participant Flow|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
11229994|NCT02403206|FG001|Participant Flow|Manual (CCC)|Continuous curvilinear capsulorhexis (CCC) performed during cataract surgery
11229995|NCT02403206|OG000|Outcome|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
11229996|NCT02403206|OG001|Outcome|Manual (CCC)|CCC performed during cataract surgery
11229997|NCT02403206|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
11229998|NCT02403206|EG001|Reported Event|Laser (LSX)|Subjects who underwent femtosecond laser-assisted cataract surgery
11229999|NCT02403206|EG002|Reported Event|Manual (CCC)|Subjects who underwent CCC-assisted cataract surgery
11230000|NCT02403271|BG000|Baseline|Phase 1b/2|All participants who received at least one dose of study treatment.
11230001|NCT02403271|FG000|Participant Flow|Phase 1b|In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 will be explored and will follow a 6 + 3 dose de-escalation design and will include a sentinel participant which will have a 3-day observation period prior to dosing of subsequent participants. Participants with one of the following three tumor types will be eligible for enrollment: NSCLC (adenocarcinoma and squamous-cell carcinoma), breast cancer (triple-negative and HER2-positive cancer), and Pancreatic cancer (adenocarcinoma).
11230002|NCT02403271|FG001|Participant Flow|Phase 2|Participants with one of three solid tumor types (Stage III/IV) will be enrolled in the Phase 2 portion of this protocol: NSCLC (adenocarcinoma and squamous-cell carcinoma), breast cancer (triple-negative and HER2-positive cancer), and pancreatic cancer (adenocarcinoma) and treated at the R2PD of ibrutinib and durvalumab determined in Phase 1b. An interim analysis will be performed to evaluate the response and the safety profile, and the study may be discontinued based on the interim efficacy and/or safety results.
11230003|NCT02403271|OG000|Outcome|Phase 1b|In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 will be explored and will follow a 6 + 3 dose de-escalation design and will include a sentinel participant which will have a 3-day observation period prior to dosing of subsequent participants. Participants with one of the following three tumor types will be eligible for enrollment: NSCLC (adenocarcinoma and squamous-cell carcinoma), breast cancer (triple-negative and HER2-positive cancer), and Pancreatic cancer (adenocarcinoma).
11230004|NCT02403271|OG000|Outcome|Phase 2|Participants with one of three solid tumor types (Stage III/IV) will be enrolled in the Phase 2 portion of this protocol: NSCLC (adenocarcinoma and squamous-cell carcinoma), breast cancer (triple-negative and HER2-positive cancer), and pancreatic cancer (adenocarcinoma) and treated at the R2PD of ibrutinib and durvalumab determined in Phase 1b. An interim analysis will be performed to evaluate the response and the safety profile, and the study may be discontinued based on the interim efficacy and/or safety results.
11230005|NCT02403271|OG000|Outcome|Phase 1b/2 (Pharmacokinetic Population)|All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data.
11230006|NCT02403271|EG000|Reported Event|Phase 1b/2|All subjects who received at least one dose of study treatment.
11230007|NCT02403479|BG000|Baseline|Saline Then Silver Colloid|Each participant uses 6 weeks of saline (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)
11230008|NCT02403479|BG001|Baseline|Silver Colloid Then Saline|Each participant uses 6 weeks of silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of saline (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks).
11230009|NCT02403479|BG002|Baseline|Total|Total of all reporting groups
11230010|NCT02403479|FG000|Participant Flow|Saline, Then Silver Colloid|"Cross-over control Each participant does 6 weeks of topical nasal saline, followed by 6 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)~Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril twice daily for a total of 6 weeks. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.~Topical Saline"
11230011|NCT02403479|FG001|Participant Flow|Silver Colloid, Then Saline|"Cross-over control Each participant receives 6 weeks of topical nasal silver colloid, followed by 6 weeks of saline (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)~Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril twice daily for a total of 6 weeks. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used."
11230012|NCT02403479|OG000|Outcome|Saline, Then Silver Colloid|"Cross-over control Each participant does 6 weeks of topical nasal saline, followed by 6 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril daily; Route= Topical intra-nasal spray; Duration= 3 months)~Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril daily for a total of three consecutive months. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used."
11230013|NCT02403479|OG001|Outcome|Silver Colloid, Then Saline|"Each participant receives the full 12 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril daily; Route= Topical intra-nasal spray; Duration= 3 months)~Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril daily for a total of three consecutive months. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used."
11357201|NCT03762993|EG001|Reported Event|Healthy Adults Reporting Vocal Fatigue|"Participants will complete vocal rest and controlled phonation~Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises"
11230014|NCT02403479|OG000|Outcome|Saline Then Silver Colloid|"Each participant uses 6 weeks of Saline first (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)~Silver Colloid: Topical silver colloid will be administered for 6 weeks. This will either occur before topical saline nasal spray. Participants are randomized as to the order of sprays. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.~Saline: Topical saline will be administered for 6 weeks. This will occur before the topical silver colloidal nasal spray. Participants are randomized as to the order of sprays."
11230015|NCT02403479|OG001|Outcome|Silver Colloid Then Saline|"Each participant uses 6 weeks of Silver Colloid first (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of saline (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks).~Silver Colloid: Topical silver colloid will be administered for 6 weeks. This will either occur before topical saline nasal spray. Participants are randomized as to the order of sprays. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.~Saline: Topical saline will be administered for 6 weeks. This will occur before the topical silver colloidal nasal spray. Participants are randomized as to the order of sprays."
11230016|NCT02403479|EG000|Reported Event|Saline Intervention|Adverse events that occurred during time using saline intervention are reported here.
11230017|NCT02403479|EG001|Reported Event|Colloidal Silver Intervention|Adverse events that occurred during time using colloidal silver intervention are reported here.
11230018|NCT02403622|BG000|Baseline|Intervention: Fecal Microbiota Preparation|"Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.~Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor~Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections."
11230019|NCT02403622|FG000|Participant Flow|Intervention: Fecal Microbiota Preparation|"Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.~Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor~Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections."
11230020|NCT02403622|OG000|Outcome|Intervention: Fecal Microbiota Preparation|"Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.~Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor~Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections."
11230021|NCT02403622|EG000|Reported Event|Intervention: Fecal Microbiota Preparation|"Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.~Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor~Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections."
11230022|NCT02403635|BG000|Baseline|Midazolam + ASP2151|"400 mg ASP2151 followed by 7.5 mg midazolam~Midazolam~ASP2151"
11230023|NCT02403635|FG000|Participant Flow|Midazolam + ASP2151|"400 mg ASP2151 followed by 7.5 mg midazolam~Midazolam~ASP2151"
11230024|NCT02403635|OG000|Outcome|Day 1|7.5 mg midazolam alone
11230025|NCT02403635|OG001|Outcome|Day 12|7.5 mg midazolam with 400 mg ASP2151
11230026|NCT02403635|OG002|Outcome|Day 19|7.5 mg midazolam alone
11230027|NCT02403635|OG003|Outcome|Day 26|7.5 mg midazolam alone
11230028|NCT02403635|OG000|Outcome|All Subjects|All subjects
11230029|NCT02403635|OG000|Outcome|Day 5|Day 5 pre-dose
11230030|NCT02403635|OG001|Outcome|Day 6|Day 6 pre-dose
11230031|NCT02403635|OG002|Outcome|Day 7|Day 7 pre-dose
11230032|NCT02403635|OG003|Outcome|Day 8|Day 8 pre-dose
11230033|NCT02403635|OG004|Outcome|Day 9|Day 9 pre-dose
11230034|NCT02403635|OG005|Outcome|Day 10|Day 10 pre-dose
11230035|NCT02403635|OG006|Outcome|Day 11|Day 11 pre-dose
11230036|NCT02403635|OG007|Outcome|Day 12|Day 12 pre-dose
11230037|NCT02403635|OG000|Outcome|Day 12|7.5 mg midazolam with 400 mg ASP2151
11230038|NCT02403635|EG000|Reported Event|Midazolam|7.5 mg midazolam
11230039|NCT02403635|EG001|Reported Event|ASP2151 After Midazolam|400 mg ASP2151 after 7.5 mg midazolam
11230040|NCT02403635|EG002|Reported Event|Midazolam With ASP2151|7.5 mg midazolam with 400 mg ASP2151
11230041|NCT02403635|EG003|Reported Event|Total|
11230042|NCT02403674|BG000|Baseline|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
11230043|NCT02403674|BG001|Baseline|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
11230044|NCT02403674|BG002|Baseline|Total|Total of all reporting groups
11357202|NCT03762681|BG000|Baseline|Part 1, Cohorts 1-4: Placebo|Healthy volunteers were administered a single dose of placebo subcutaneously (SC).
11357203|NCT03762681|BG001|Baseline|Part 1, Cohort 1: 0.1 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC.
11230045|NCT02403674|FG000|Participant Flow|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, once daily (q.d.) by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
11230046|NCT02403674|FG001|Participant Flow|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
11230047|NCT02403674|OG000|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
11230048|NCT02403674|OG001|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
11230049|NCT02403674|EG000|Reported Event|MK-1439A (DOR+LAM+TEN)|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
11230050|NCT02403674|EG001|Reported Event|ATRIPLA (EFA+EMT+TEN)|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
11230051|NCT02403778|BG000|Baseline|Ipilimumab|"Arm A (No VESANOIDTherapy) will receive the standard of care treatment with ipilimumab only, receiving the standard 4 doses of either 3 or 10 mg/kg ipilimumab every 3 weeks.~Ipilimumab: Ipilimumab is current standard of care treatment for melanoma."
11230052|NCT02403778|BG001|Baseline|VESANOID|"Arm B (VESANOID Therapy) will receive the standard 4 doses of either 3 or 10 mg/kg ipilimumab every three weeks plus the supplemental treatment of 150 mg/m2 of VESANOID orally for 3 days surrounding each dose of ipilimumab (day -1, day 0, day +1) for a total of 12 days of VESANOID treatment.~VESANOID: All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).~Ipilimumab: Ipilimumab is current standard of care treatment for melanoma."
11230053|NCT02403778|BG002|Baseline|Total|Total of all reporting groups
11230054|NCT02403778|FG000|Participant Flow|Ipilimumab|"Arm A (No VESANOIDTherapy) will receive the standard of care treatment with ipilimumab only, receiving the standard 4 doses of either 3 or 10 mg/kg ipilimumab every 3 weeks.~Ipilimumab: Ipilimumab is current standard of care treatment for melanoma."
11230055|NCT02403778|FG001|Participant Flow|VESANOID|"Arm B (VESANOID Therapy) will receive the standard 4 doses of either 3 or 10 mg/kg ipilimumab every three weeks plus the supplemental treatment of 150 mg/m2 of VESANOID orally for 3 days surrounding each dose of ipilimumab (day -1, day 0, day +1) for a total of 12 days of VESANOID treatment.~VESANOID: All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).~Ipilimumab: Ipilimumab is current standard of care treatment for melanoma."
11230056|NCT02403778|OG000|Outcome|Ipilimumab|"Arm A (No VESANOIDTherapy) will receive the standard of care treatment with ipilimumab only, receiving the standard 4 doses of either 3 or 10 mg/kg ipilimumab every 3 weeks.~Ipilimumab: Ipilimumab is current standard of care treatment for melanoma."
11230057|NCT02403778|OG001|Outcome|VESANOID|"Arm B (VESANOID Therapy) will receive the standard 4 doses of either 3 or 10 mg/kg ipilimumab every three weeks plus the supplemental treatment of 150 mg/m2 of VESANOID orally for 3 days surrounding each dose of ipilimumab (day -1, day 0, day +1) for a total of 12 days of VESANOID treatment.~VESANOID: All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).~Ipilimumab: Ipilimumab is current standard of care treatment for melanoma."
11230058|NCT02403778|EG000|Reported Event|Ipilimumab|"Arm A (No VESANOIDTherapy) will receive the standard of care treatment with ipilimumab only, receiving the standard 4 doses of either 3 or 10 mg/kg ipilimumab every 3 weeks.~Ipilimumab: Ipilimumab is current standard of care treatment for melanoma."
11230059|NCT02403778|EG001|Reported Event|VESANOID|"Arm B (VESANOID Therapy) will receive the standard 4 doses of either 3 or 10 mg/kg ipilimumab every three weeks plus the supplemental treatment of 150 mg/m2 of VESANOID orally for 3 days surrounding each dose of ipilimumab (day -1, day 0, day +1) for a total of 12 days of VESANOID treatment.~VESANOID: All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).~Ipilimumab: Ipilimumab is current standard of care treatment for melanoma."
11230060|NCT02403817|BG000|Baseline|Eye Movement Game Control|"Cognitive Training Eye Motor Training~Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.~Eye Motor Training: Game play will be controlled by the player's eye movements (via an eye tracking device)"
11230061|NCT02403817|BG001|Baseline|Hand Movement Game Control|"Cognitive Training Hand Motor Training~Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.~Hand Motor Training: Game play will be controlled by the player's hand movements (via a joystick)."
11230062|NCT02403817|BG002|Baseline|Total|Total of all reporting groups
11230063|NCT02403817|FG000|Participant Flow|Eye Movement Game Control|"Cognitive Training Eye Motor Training~Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.~Eye Motor Training: Gameplay will be controlled by the player's eye movements (via an eye tracking device)"
11230064|NCT02403817|FG001|Participant Flow|Hand Movement Game Control|"Cognitive Training Hand Motor Training~Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.~Hand Motor Training: Gameplay will be controlled by the player's hand movements (via a joystick)."
11230065|NCT02403817|OG000|Outcome|Eye Movement Game Control|"Cognitive Training Eye Motor Training~Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.~Eye Motor Training: Gameplay will be controlled by the player's eye movements (via an eye tracking device)"
11230066|NCT02403817|OG001|Outcome|Hand Movement Game Control|"Cognitive Training Hand Motor Training~Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.~Hand Motor Training: Gameplay will be controlled by the player's hand movements (via a joystick)."
11230067|NCT02403817|EG000|Reported Event|Eye Movement Game Control|"Cognitive Training Eye Motor Training~Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.~Eye Motor Training: Gameplay will be controlled by the player's eye movements (via an eye tracking device)"
11230068|NCT02403817|EG001|Reported Event|Hand Movement Game Control|"Cognitive Training Hand Motor Training~Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.~Hand Motor Training: Gameplay will be controlled by the player's hand movements (via a joystick)."
11230069|NCT02403830|BG000|Baseline|Whole Study Population|Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm.
11230070|NCT02403830|FG000|Participant Flow|Methylnaltrexone First|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. In this arm patients received methylnaltrexone at visit 1. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm (placebo).~Methylnaltrexone: Methylnaltrexone will be administered diluted with 5 ml of normal saline as a single iv bolus~Morphine: After methylnaltrexone, patients will receive 5-mg intravenous morphine~Ticagrelor: After morphine administration, patients will receive a 180-mg ticagrelor loading dose"
11230071|NCT02403830|FG001|Participant Flow|Placebo First|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. In this arm patients received placebo at visit 1. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm (methylnaltrexone).~Placebo: Placebo will be administered as a 0.9% sodium chloride iv injection~Morphine: After methylnaltrexone, patients will receive 5-mg intravenous morphine~Ticagrelor: After morphine administration, patients will receive a 180-mg ticagrelor loading dose"
11230072|NCT02403830|OG000|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
11230073|NCT02403830|OG001|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
11233928|NCT02431559|OG001|Outcome|Phase 1, Dose Level 0b|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
11230074|NCT02403830|EG000|Reported Event|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
11230075|NCT02403830|EG001|Reported Event|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
11230076|NCT02403895|BG000|Baseline|Open-label AZD2014|Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
11230077|NCT02403895|FG000|Participant Flow|Open-label AZD2014|Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
11230078|NCT02403895|OG000|Outcome|Open-label AZD2014|Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
11230079|NCT02403895|EG000|Reported Event|Open-label AZD2014|Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
11230080|NCT02403986|BG000|Baseline|R. Vital Skinboosters Lidocaine (Three)|"Treatment with three initial sessions~Restylane Vital Skinboosters Lidocaine"
11230081|NCT02403986|BG001|Baseline|R. Vital Skinboosters Lidocaine (Two)|"Treatment with two initial sessions~Restylane Vital Skinboosters Lidocaine"
11230082|NCT02403986|BG002|Baseline|Total|Total of all reporting groups
11230083|NCT02403986|FG000|Participant Flow|R. Vital Skinboosters Lidocaine (Three)|"Treatment with three initial sessions~Restylane Vital Skinboosters Lidocaine"
11230084|NCT02403986|FG001|Participant Flow|R. Vital Skinboosters Lidocaine (Two)|"Treatment with two initial sessions~Restylane Vital Skinboosters Lidocaine"
11230085|NCT02403986|OG000|Outcome|R. Vital Skinboosters Lidocaine (Three)|"Treatment with three initial sessions~Restylane Vital Skinboosters Lidocaine"
11230086|NCT02403986|OG001|Outcome|R. Vital Skinboosters Lidocaine (Two)|"Treatment with two initial sessions~Restylane Vital Skinboosters Lidocaine"
11230087|NCT02403986|EG000|Reported Event|R. Vital Skinboosters Lidocaine (Three)|"Treatment with three initial sessions~Restylane Vital Skinboosters Lidocaine"
11230088|NCT02403986|EG001|Reported Event|R. Vital Skinboosters Lidocaine (Two)|"Treatment with two initial sessions~Restylane Vital Skinboosters Lidocaine"
11230089|NCT02403999|BG000|Baseline|Test Shampoo|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230090|NCT02403999|BG001|Baseline|Test Bath Foam|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230091|NCT02403999|BG002|Baseline|Test Head to Toe Wash|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230092|NCT02403999|BG003|Baseline|Total|Total of all reporting groups
11230093|NCT02403999|FG000|Participant Flow|Test Shampoo|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230094|NCT02403999|FG001|Participant Flow|Test Bath Foam|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230095|NCT02403999|FG002|Participant Flow|Test Head to Toe Wash|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230096|NCT02403999|OG000|Outcome|Test Shampoo|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230097|NCT02403999|OG001|Outcome|Test Bath Foam|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230098|NCT02403999|OG002|Outcome|Test Head to Toe Wash|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230099|NCT02403999|EG000|Reported Event|Test Shampoo|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230100|NCT02403999|EG001|Reported Event|Test Bath Foam|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230101|NCT02403999|EG002|Reported Event|Test Head to Toe Wash|Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
11230102|NCT02404025|BG000|Baseline|Eltrombopag+Rabbit ATG/CsA Arm|Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion.
11233929|NCT02431559|OG002|Outcome|Phase 1, Dose Level +1|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
11351428|NCT03993392|BG000|Baseline|TM Buprenorphine Followed by SUBLOCADE 300 mg|Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
11351429|NCT03993392|FG000|Participant Flow|TM Buprenorphine Followed by SUBLOCADE 300 mg|Participants with a diagnosis of opioid use disorder (OUD) stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
11351430|NCT03993392|OG000|Outcome|TM Buprenorphine Followed by SUBLOCADE 300 mg|Participants with a diagnosis of OUD stopped use of their current opioid prior to coming to the clinic to be assessed for withdrawal symptoms. If confirmed to be in withdrawal, participants were administered 4 mg transmucosal (TM) buprenorphine. If tolerated without sensitivity, clinical signs of sedation, or precipitated withdrawal, 300 mg SUBLOCADE was administered. Following SUBLOCADE administration, participants remained in the clinic for approximately 48 hours and were assessed for safety and tolerability, as well as for any signs of precipitated withdrawal. Participants returned to the clinic weekly, until the end-of-treatment (EOT) visit (28 days after SUBLOCADE administration).
11351431|NCT03993392|EG000|Reported Event|Induction Phase|Treatment-emergent adverse events (TEAEs) where the start date/time of the event is on or after the date/time of the administration of transmucosal (TM) buprenorphine (BUP) for induction but prior to the date/time of the SUBLOCADE injection.
11351432|NCT03993392|EG001|Reported Event|Safety Population (Post -SUBLOCADE)|Treatment-emergent adverse events (TEAEs) where the start date/time of the event is post-SUBLOCADE injection.
11351433|NCT03989427|BG000|Baseline|Brushing Flossing (BF) First|"Participants used Brushing first and Flossing later (BF) sequence for 2 weeks. After a washout period of 1 week they used flossing first and brushing later (FB) sequence~Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized.~The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head. The method of flossing used was Spool method of flossing."
11351434|NCT03989427|BG001|Baseline|Flossing Brushing (FB) First|"Participants used Flossing first and Brushing later (FB) sequence for a period of 2 weeks. After a washout period of 1 week they used Brushing first and flossing later (BF) sequence~Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized.~The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and the method of flossing used was Spool method of flossing."
11351435|NCT03989427|BG002|Baseline|Total|Total of all reporting groups
11351436|NCT03989427|FG000|Participant Flow|Brushing Flossing (BF)|"Participants used Brushing first and Flossing (BF) sequence in the study. After 1 week wash out period they used Flossing first and brushing (FB) later sequence.~Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized.~The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and Spool method of flossing was used."
11351437|NCT03989427|FG001|Participant Flow|Flossing Brushing (FB)|"Participants used Flossing first and brush (FB) later sequence in the study. After 1 week wash out period they used Brushing first and flossing (FB) later sequence.~Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized.~The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and Spool method of flossing was used."
11351438|NCT03989427|OG000|Outcome|Brushing First and Flossing Later (BF)|Participants who performed Brushing first and flossing later (BF) in either the first or last 2 weeks of the study
11351439|NCT03989427|OG001|Outcome|Flossing First and Brushing Later (FB)|Participants who performed Flossing first and brushing later (FB) in either the first or last 2 weeks of the study.
11351440|NCT03989427|OG000|Outcome|Brushing First and Flossing Later (BF)|Participants who performed Brushing First and Flossing Later(BF) in either the first or last 2 weeks of the study.
11351441|NCT03989427|OG001|Outcome|Flossing First and Brushing Later (FB)|Participants who performed Flossing First and Brushing later (FB) in either the first or last 2 weeks of the study.
11351442|NCT03989427|EG000|Reported Event|Brushing and Flossing|No adverse events were reported
11351443|NCT03981822|BG000|Baseline|Part A: VP-102 2-hour|VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments.
11351444|NCT03981822|BG001|Baseline|Part A: VP-102 6-hour|VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.
11351445|NCT03981822|BG002|Baseline|Part A: VP-102 24-hour|VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.
11351446|NCT03981822|BG003|Baseline|Part A: Placebo|Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments.
11351447|NCT03981822|BG004|Baseline|Part B: VP-102 6-hour|VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.
11351448|NCT03981822|BG005|Baseline|Part B: 6-hour-Placebo|Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.
11351449|NCT03981822|BG006|Baseline|Part B: VP-102 24-hour|VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.
11351450|NCT03981822|BG007|Baseline|Part B: 24-hour-Placebo|Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.
11230103|NCT02404025|FG000|Participant Flow|Eltrombopag+Rabbit ATG/CsA Arm|Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion.
11230104|NCT02404025|OG000|Outcome|Eltrombopag+Rabbit ATG/CsA Arm|Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion.
11230105|NCT02404025|EG000|Reported Event|Eltrombopag+ATG/CsA|Eltrombopag+ATG/CsA
11230106|NCT02404103|BG000|Baseline|Flunisolide 160 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
11230107|NCT02404103|BG001|Baseline|Flunisolide 320 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
11230108|NCT02404103|BG002|Baseline|Total|Total of all reporting groups
11230109|NCT02404103|FG000|Participant Flow|Flunisolide 160 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
11230110|NCT02404103|FG001|Participant Flow|Flunisolide 320 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
11230111|NCT02404103|OG000|Outcome|Flunisolide 160 mcg Per Day Pretreatment - Baseline|"Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
11230112|NCT02404103|OG001|Outcome|Flunisolide 320 mcg Per Day Pretreatment - Baseline|"Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
11230113|NCT02404103|OG002|Outcome|Flunisolide 160 mcg Per Day Posttreatment - 6 Wks|After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period
11230114|NCT02404103|OG003|Outcome|Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks|"After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
11230115|NCT02404103|OG000|Outcome|Flunisolide 160 mcg Per Day Pretreatment - Baseline|"Before Patients received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
11230116|NCT02404103|OG001|Outcome|Flunisolide 320 mcg Per Day Pretreatment - Baseline|"Before Patients received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
11351451|NCT03981822|BG008|Baseline|Total|Total of all reporting groups
11230117|NCT02404103|OG002|Outcome|Flunisolide 160 mcg Per Day Posttreatment - 6 Wks|After 6 weeks treatment value forPatients who received inhaled Flunisolide HFA 80 mg twice per day.
11230118|NCT02404103|OG003|Outcome|Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks|After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 160 mg twiece a day.
11230119|NCT02404103|OG000|Outcome|Flunisolide 160 mcg Per Day Pretreatment - Baseline|Baseline in Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period
11230120|NCT02404103|OG001|Outcome|Flunisolide 320 mcg Per Day Pretreatment - Baseline|Baseline in patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period
11230121|NCT02404103|OG002|Outcome|Flunisolide 160 mcg Per Day Posttreatment - 6 Wks|Six week followup in Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period
11230122|NCT02404103|OG003|Outcome|Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks|Six week followup in patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period
11230123|NCT02404103|EG000|Reported Event|Flunisolide 160 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
11230124|NCT02404103|EG001|Reported Event|Flunisolide 320 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
11230125|NCT02404168|BG000|Baseline|Lamotrigine Tablet|Sequence: generic first, then brand, then brand, and then generic
11230126|NCT02404168|FG000|Participant Flow|Lamotrigine Tablet|Sequence: generic first, then brand, then brand, and then generic. Each of the four arms will be about two weeks in duration. During the study, subjects will receive their on-going therapeutic lamotrigine regimen of either 200mg, 400mg, or 600mg total daily dosage, divided in twice-a-day doses (i.e. every 12 hours). In the study, 100mg lamotrigine tablets (brand or generic) will be dispensed to the subject at the start of each study arm.
11230127|NCT02404168|OG000|Outcome|Active Comparator: Lamotrigine Brand|lamotrigine tablet Lamictal
11230128|NCT02404168|OG001|Outcome|Experimental: Lamotrigine Generic|lamotrigine tablet Teva
11230129|NCT02404168|EG000|Reported Event|Active Comparator: Lamotrigine Brand|lamotrigine tablet Lamictal
11230130|NCT02404168|EG001|Reported Event|Experimental: Lamotrigine Generic|lamotrigine tablet Teva
11357204|NCT03762681|BG002|Baseline|Part 1, Cohort 2: 0.3 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC.
11230131|NCT02404220|BG000|Baseline|ENTO 200 mg + VCR 0.5 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 200 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230132|NCT02404220|BG001|Baseline|ENTO 400 mg + VCR 0.5 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230133|NCT02404220|BG002|Baseline|ENTO 400 mg + VCR 1.0 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230134|NCT02404220|BG003|Baseline|ENTO 400 mg + VCR 2.0 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230135|NCT02404220|BG004|Baseline|Total|Total of all reporting groups
11230136|NCT02404220|FG000|Participant Flow|ENTO 200 mg + VCR 0.5 mg|"Monotherapy Lead-In (Day -7 to Day -1): Entospletinib (ENTO) 200 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with vincristine (VCR) 0.5 mg intravenously (IV) on Days 1, 8, 15, and 22 of each cycle; dexamethasone (DEX) 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and central nervous system (CNS) prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a complete remission (CR) received stem cell transplant (SCT) (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a partial response [PR]) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230137|NCT02404220|FG001|Participant Flow|ENTO 400 mg + VCR 0.5 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230138|NCT02404220|FG002|Participant Flow|ENTO 400 mg + VCR 1.0 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230139|NCT02404220|FG003|Participant Flow|ENTO 400 mg + VCR 2.0 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11357205|NCT03762681|BG003|Baseline|Part 1, Cohort 3: 1.0 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC.
11230140|NCT02404220|OG000|Outcome|ENTO 200 mg + VCR 0.5 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 200 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230141|NCT02404220|OG001|Outcome|ENTO 400 mg + VCR 0.5 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230142|NCT02404220|OG002|Outcome|ENTO 400 mg + VCR 1.0 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230143|NCT02404220|OG003|Outcome|ENTO 400 mg + VCR 2.0 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230144|NCT02404220|EG000|Reported Event|ENTO 200 mg + VCR 0.5 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 200 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230145|NCT02404220|EG001|Reported Event|ENTO 400 mg + VCR 0.5 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230146|NCT02404220|EG002|Reported Event|ENTO 400 mg + VCR 1.0 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11230147|NCT02404220|EG003|Reported Event|ENTO 400 mg + VCR 2.0 mg|"Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent.~Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle.~Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle."
11233930|NCT02431559|OG003|Outcome|Phase 2|Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
11230148|NCT02404285|BG000|Baseline|Vehicle|"Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:~Lesions were counted and right, left and forward facing photographs were taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Vehicle: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should was not to be applied around the eyes or near the mucous membranes. No other acne treatments was applied to the face during study participation."
11230149|NCT02404285|BG001|Baseline|NAG (Next Science Acne Gel)|"Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:~Lesions were counted and right, left and forward facing photographs were taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Next Science Acne Gel: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should was not to be applied around the eyes or near the mucous membranes. No other acne treatments was applied to the face during study participation."
11230150|NCT02404285|BG002|Baseline|Total|Total of all reporting groups
11230151|NCT02404285|FG000|Participant Flow|Vehicle|"Subjects will be treated with once daily vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:~Lesions will be counted and right, left and forward facing photographs will be taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel."
11230152|NCT02404285|FG001|Participant Flow|NAG (Next Science Acne Gel)|"Subjects will be treated with once daily NAG and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:~Lesions will be counted and right, left and forward facing photographs will be taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel."
11230153|NCT02404285|OG000|Outcome|Vehicle|"Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits:~1. Lesions were counted and right, left and forward facing photographs were taken"
11230154|NCT02404285|OG001|Outcome|NAG (Next Science Acne Gel)|"Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits:~1. Lesions were counted and right, left and forward facing photographs were taken"
11230155|NCT02404285|OG000|Outcome|Vehicle|"Subjects will be treated with once daily vehicle and the following were assessed at baseline, 2,4,8 and 12 week visits:~Lesions will be counted and right, left and forward facing photographs will be taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel."
11230156|NCT02404285|OG001|Outcome|NAG (Next Science Acne Gel)|"Subjects will be treated with once daily NAG and and the following was assessed at baseline, 2,4,8 and 12 week visits:~Lesions will be counted and right, left and forward facing photographs will be taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel."
11230157|NCT02404285|OG000|Outcome|Vehicle|Subjects were treated with once daily vehicle and attended baseline, 2,4,8 and 12 week visits and the number of non-inflammatory lesions were counted.
11230158|NCT02404285|OG001|Outcome|NAG (Next Science Acne Gel)|Subjects were treated with once daily NAG and attended baseline, 2,4,8 and 12 week visits and the number of non-inflammatory lesions were counted.
11230159|NCT02404285|OG000|Outcome|Vehicle|"Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:~Lesions will be counted and right, left and forward facing photographs will be taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel."
11230160|NCT02404285|OG001|Outcome|NAG (Next Science Acne Gel)|"Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:~Lesions will be counted and right, left and forward facing photographs will be taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel."
11351452|NCT03981822|FG000|Participant Flow|Part A: VP-102 2-hour|VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
11351453|NCT03981822|FG001|Participant Flow|Part A: VP-102 6-hour Group|VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
11351454|NCT03981822|FG002|Participant Flow|Part A: VP-102 24-hour Group|VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
11351455|NCT03981822|FG003|Participant Flow|Part A: Placebo|This includes 3 subjects that received placebo (1 each for the 2-hour; 6-hour and 24-hour)
11351456|NCT03981822|FG004|Participant Flow|Part B: VP-102 6-hour|VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
11351457|NCT03981822|FG005|Participant Flow|Part B: Placebo 6-hour|Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
11351458|NCT03981822|FG006|Participant Flow|Part B: VP-102 24-hour|VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
11351459|NCT03981822|FG007|Participant Flow|Part B: Placebo 24-hour|Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
11351460|NCT03981822|OG000|Outcome|Part B Pooled With Part A: VP-102 6-hour|Data will be summarized for both Part B pooled with Part A for the applicable treatments.
11351461|NCT03981822|OG001|Outcome|Part B Pooled With Part A: Placebo 6-hour|Data will be summarized for both Part B pooled with Part A for the applicable treatments.
11351462|NCT03981822|OG002|Outcome|Part B Pooled With Part A VP-102 24-hour|Data will be summarized for both Part B pooled with Part A for the applicable treatments.
11351463|NCT03981822|OG003|Outcome|Part B Pooled With Part A: Placebo 24-hour|Data will be summarized for both Part B pooled with Part A for the applicable treatments.
11351464|NCT03981822|EG000|Reported Event|Part B Pooled With Part A: VP-102 6-hour|Data will be summarized for both Part B pooled with Part A for the applicable treatments.
11351465|NCT03981822|EG001|Reported Event|Part B Pooled With Part A: Placebo 6-hour|Data will be summarized for both Part B pooled with Part A for the applicable treatments.
11351466|NCT03981822|EG002|Reported Event|Part B Pooled With Part A VP-102 24-hour|Data will be summarized for both Part B pooled with Part A for the applicable treatments.
11351467|NCT03981822|EG003|Reported Event|Part B Pooled With Part A: Placebo 24-hour|Data will be summarized for both Part B pooled with Part A for the applicable treatments.
11351468|NCT03981822|EG004|Reported Event|Part A: VP-102 2-hour|Data summarized for VP-102 2-hour group.
11351469|NCT03981822|EG005|Reported Event|Part A: Placebo 2-hour|Data summarized for VP-102 2-hour group..
11351470|NCT03992482|BG000|Baseline|IVIG-Eye Drop|"Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks~Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks"
11351471|NCT03992482|BG001|Baseline|Placebo-Eye Drop|"Normal Saline Eye Drops (0.9% NaCl)~Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks"
11351472|NCT03992482|BG002|Baseline|Total|Total of all reporting groups
11351473|NCT03992482|FG000|Participant Flow|IVIG-Eye Drop|"Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks~Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks"
11351474|NCT03992482|FG001|Participant Flow|Placebo-Eye Drop|"Normal Saline Eye Drops (0.9% NaCl)~Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks"
11351475|NCT03992482|OG000|Outcome|IVIG-Eye Drop|"Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks~Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks"
11351476|NCT03992482|OG001|Outcome|Placebo-Eye Drop|"Normal Saline Eye Drops (0.9% NaCl)~Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks"
11351477|NCT03992482|EG000|Reported Event|IVIG-Eye Drop|"Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks~Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks"
11351478|NCT03992482|EG001|Reported Event|Placebo-Eye Drop|"Normal Saline Eye Drops (0.9% NaCl)~Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks"
11351479|NCT03993119|BG000|Baseline|Dabigatran|Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351480|NCT03993119|BG001|Baseline|Rivaroxaban|Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351481|NCT03993119|BG002|Baseline|Apixaban|Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351482|NCT03993119|BG003|Baseline|Edoxaban|Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351483|NCT03993119|BG004|Baseline|Total|Total of all reporting groups
11351484|NCT03993119|FG000|Participant Flow|Dabigatran|Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351485|NCT03993119|FG001|Participant Flow|Rivaroxaban|Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351486|NCT03993119|FG002|Participant Flow|Apixaban|Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351487|NCT03993119|FG003|Participant Flow|Edoxaban|Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351488|NCT03993119|OG000|Outcome|Sex: Male|This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351489|NCT03993119|OG001|Outcome|Sex: Female|This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351490|NCT03993119|OG000|Outcome|Age: 75-79 Years|This arm included all patients aged between 75-79 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351491|NCT03993119|OG001|Outcome|Age: 80-84 Years|This arm included all patients aged between 80-84 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351492|NCT03993119|OG002|Outcome|Age: ≥85 Years|This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351493|NCT03993119|OG000|Outcome|Heart Failure: No|This arm included patients who participated in the study and had no prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351494|NCT03993119|OG001|Outcome|Heart Failure: Yes|This arm included patients who participated in the study and had prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351495|NCT03993119|OG000|Outcome|Coronary Artery Disease: No|This arm included patients who participated in the study and had no coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351496|NCT03993119|OG001|Outcome|Coronary Artery Disease: Yes|This arm included patients who participated in the study and had coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351497|NCT03993119|OG000|Outcome|Diabetes: No|This arm included patients who participated in the study and had no diabetes were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351498|NCT03993119|OG001|Outcome|Diabetes: Yes|This arm included patients who participated in the study and had diabetes and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351499|NCT03993119|OG000|Outcome|Chronic Kidney Disease: No|This arm included patients who participated in the study and had no chronic kidney disease were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11351500|NCT03993119|OG001|Outcome|Chronic Kidney Disease: Yes|This arm included patients who participated in the study and had chronic kidney disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
11357206|NCT03762681|BG004|Baseline|Part 1, Cohort 4: 1.5 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC.
11230161|NCT02404285|EG000|Reported Event|Vehicle|"Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:~Lesions were counted and right, left and forward facing photographs were taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Vehicle: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry."
11230162|NCT02404285|EG001|Reported Event|NAG (Next Science Acne Gel)|"Subjects were treated with once daily NAG and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:~Lesions were counted and right, left and forward facing photographs were taken~Investigator Global Assessment~Acne Quality of Life Questionnaire~Treatment Area Assessment by Investigator~Next Science Acne Gel: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry."
11230163|NCT02404311|BG000|Baseline|Part A Only: Group 1 (Vaccine)|Participants did not go on to Part B. In Part A, participants received ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
11230164|NCT02404311|BG001|Baseline|Part A Only: Group 2 (Placebo)|Participants did not go on to Part B. In Part A, participants received Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
11230165|NCT02404311|BG002|Baseline|Part A, Group 1 (Vaccine) + Part B, Group 1a (Vaccine)|Participants completed Part A in Group 1 (Vaccine), joined Part B and were randomized to Group 1a (Vaccine): ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
11230166|NCT02404311|BG003|Baseline|Part A, Group 1 (Vaccine) + Part B, Group 1b: Vaccine/Placeb|Participants completed Part A in Group 1 (Vaccine), joined Part B and were randomized to Group 1b (Vaccine/Placebo ): placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
11230167|NCT02404311|BG004|Baseline|Part A, Group 2 (Placebo) + Part B, Group 2 (Placebo)|Participants completed Part A in Group 2 (Placebo), joined Part B and received placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
11230168|NCT02404311|BG005|Baseline|Total|Total of all reporting groups
11230169|NCT02404311|FG000|Participant Flow|Part A, Group 1: Vaccine|Participants receive ALVAC-HIV (vCP2438) injections at months 0 and 1, and ALVAC-HIV (vCP2438) + bivalent subtype C gp120/MF59® injections at months 3, 6, and 12.
11230170|NCT02404311|FG001|Participant Flow|Part A, Group 2: Placebo|Participants receive placebo for ALVAC-HIV (vCP2438) at months 0 and 1, and placebo for ALVAC-HIV (vCP2438) + placebo for bivalent subtype C gp120/MF59® injections at months 3, 6, and 12.
11230171|NCT02404311|FG002|Participant Flow|Part B, Group 1a: Vaccine|Participants originally in Part A Group 1 receive ALVAC-HIV (vCP2438) + bivalent subtype C gp120/MF59® (vCP2438) injections at month 30.
11230172|NCT02404311|FG003|Participant Flow|Part B, Group 1b: Vaccine + Placebo|Participants originally in Part A Group 1 receive placebo for ALVAC-HIV (vCP2438) + active bivalent subtype C gp120/MF59® at month 30.
11230173|NCT02404311|FG004|Participant Flow|Part B, Group 2: Placebo|Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV (vCP2438) + placebo for bivalent subtype C gp120/MF59® at month 30.
11230174|NCT02404311|OG000|Outcome|Part A, Group 1: Vaccine|ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
11230175|NCT02404311|OG001|Outcome|Part A, Group 2: Placebo|Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
11230176|NCT02404311|OG000|Outcome|Part B, Group 1a: Vaccine|Participants originally in Part A Group 1 (Vaccine) receive ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
11230177|NCT02404311|OG001|Outcome|Part B, Group 1b: Vaccine/Placebo|Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
11230178|NCT02404311|OG002|Outcome|Part B, Group 2: Placebo|Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
11230179|NCT02404311|EG000|Reported Event|Part A, Group 1: Vaccine|ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
11230180|NCT02404311|EG001|Reported Event|Part A, Group 2: Placebo|Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
11230181|NCT02404311|EG002|Reported Event|Part B, Group 1a: Vaccine|Participants originally in Part A Group 1 (Vaccine) receive ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
11230182|NCT02404311|EG003|Reported Event|Part B, Group 1b: Vaccine/Placebo|Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
11230183|NCT02404311|EG004|Reported Event|Part B, Group 2: Placebo|Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
11230184|NCT02404350|BG000|Baseline|Secukinumab 150 mg Without Load|Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
11230185|NCT02404350|BG001|Baseline|Secukinumab 150 mg With Load|Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
11230186|NCT02404350|BG002|Baseline|Secukinumab 300 mg With Load|Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
10887855|NCT00503308|EG001|Reported Event|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
11230187|NCT02404350|BG003|Baseline|Placebo|Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
11230188|NCT02404350|BG004|Baseline|Total|Total of all reporting groups
11230189|NCT02404350|FG000|Participant Flow|Secukinumab 150 mg Without Load|Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab as 1 milliliter (mL) Pre-Filled Syringe (PFS) and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
11230190|NCT02404350|FG001|Participant Flow|Secukinumab 150 mg With Load|Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
11230191|NCT02404350|FG002|Participant Flow|Secukinumab 300 mg With Load|Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
11230192|NCT02404350|FG003|Participant Flow|Placebo|Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
11230193|NCT02404350|OG000|Outcome|Secukinumab 150 mg Without Load|Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
11230194|NCT02404350|OG001|Outcome|Secukinumab 150 mg With Load|Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
11230195|NCT02404350|OG002|Outcome|Secukinumab 300 mg With Load|Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
11230196|NCT02404350|OG003|Outcome|Placebo|Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
11230197|NCT02404350|EG000|Reported Event|Secukinumab 150 mg Without Load|Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
11230198|NCT02404350|EG001|Reported Event|Secukinumab 150 mg With Load|Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
11230199|NCT02404350|EG002|Reported Event|Secukinumab 300 mg With Load|Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
11230200|NCT02404350|EG003|Reported Event|Secukinumab Total|Participants were s.c. administered with secukinumab and secukinumab matching placebo at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
11230201|NCT02404350|EG004|Reported Event|Placebo|Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
11230202|NCT02404389|BG000|Baseline|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
11230203|NCT02404389|BG001|Baseline|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
11230204|NCT02404389|BG002|Baseline|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications
11230205|NCT02404389|BG003|Baseline|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications
11230206|NCT02404389|BG004|Baseline|Aldara|Aldara cream 3 applications per week
10887856|NCT00503399|BG000|Baseline|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
11230207|NCT02404389|BG005|Baseline|Total|Total of all reporting groups
11230208|NCT02404389|FG000|Participant Flow|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
11230209|NCT02404389|FG001|Participant Flow|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
11230210|NCT02404389|FG002|Participant Flow|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications
11230211|NCT02404389|FG003|Participant Flow|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications
11230212|NCT02404389|FG004|Participant Flow|Aldara|Aldara cream 3 applications per week
11351501|NCT03993119|OG000|Outcome|Dabigatran|Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351502|NCT03993119|OG001|Outcome|Rivaroxaban|Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351503|NCT03993119|OG002|Outcome|Apixaban|Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351504|NCT03993119|OG003|Outcome|Edoxaban|Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
11351505|NCT03993119|OG000|Outcome|≤4 Months|All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months.
11351506|NCT03993119|OG001|Outcome|>4 Months|All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC)>4 months.
11351507|NCT03993119|OG001|Outcome|>4 Months|All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
11351508|NCT03993119|OG001|Outcome|>4 Months|All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months.
11351509|NCT03993119|OG001|Outcome|>4 Months|All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months..
11351510|NCT03993119|EG000|Reported Event|All Dabigatran Patients|This group included all patients who received dabigatran either as first NOAC (patients who the first NOAC prescribed was dabigatran), or as second NOAC (patients who stopped the first prescribed NOAC and received dabigatran as second NOAC), or as third NOAC (patients who stopped the second prescribed NOAC and received dabigatran as third NOAC).
11351511|NCT03991494|BG000|Baseline|Pamiparib|Research Phase (Part 1): participants received a single dose of 60 mg [14C]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally
11351512|NCT03991494|FG000|Participant Flow|Pamiparib|Research Phase (Part 1): participants received a single dose of 60 mg [14C]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally
11351513|NCT03991494|OG000|Outcome|Pamiparib|Research Phase (Part 1): participants received a single dose of 60 mg [14C]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally
11351514|NCT03991494|OG000|Outcome|Pamiparib|"Research Phase (Part 1): participants received a single dose of 60 mg [14C]-pamiparib orally~Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally"
11351515|NCT03991494|OG000|Outcome|Pamiparib|"Research Phase (Part 1): participants received 60 mg [14C]-pamiparib twice daily orally~Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally"
11351516|NCT03991494|EG000|Reported Event|Pamiparib|Research Phase (Part 1): participants received a single dose of 60 mg [14C]-pamiparib orally Treatment phase (Part 2): participants received 60 mg pamiparib twice daily orally
11351517|NCT03989570|BG000|Baseline|Group I (A Group)|"31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).~erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes"
11351518|NCT03989570|BG001|Baseline|Group II (B Group)|"31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).~transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected"
11351519|NCT03989570|BG002|Baseline|Group III (C Group)|"31 patients anesthetized with the protocol followed by Minia University Hospital~control group: placebo"
11351520|NCT03989570|BG003|Baseline|Total|Total of all reporting groups
11351521|NCT03989570|FG000|Participant Flow|Group I (A Group)|"31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).~erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes"
11351522|NCT03989570|FG001|Participant Flow|Group II (B Group)|"31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).~transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected"
11351523|NCT03989570|FG002|Participant Flow|Group III (C Group)|"31 patients anesthetized with the protocol followed by Minia University Hospital~control group: placebo"
11351524|NCT03989570|OG000|Outcome|Group I (A Group)|"31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).~erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes"
11357207|NCT03762681|BG005|Baseline|Part 2a: Placebo|Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W).
11357208|NCT03762681|BG006|Baseline|Part 2a, Arm 1: 0.2 mg/kg RO7239958|Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11167029|NCT01976741|EG000|Reported Event|Rogaratinib Total Dose Escalation|Participants with any type of solid tumor received escalating doses of Rogaratinib oral solution or tablet. The actual dose-escalation cohorts were 100 mg (50 mg BID), 200 mg (100 mg BID), 400 mg (200 mg BID), 800 mg (400 mg BID), 1200 mg (600 mg BID), and 1600 mg (800 mg BID). The participants in the 100 mg and 200 mg dose-escalation cohorts received oral solution and the participants in all the subsequent dose-escalation cohorts received tablet. And as an exception, on C1D-3 in the 200 mg dose-escalation cohort, the participants received tablet instead of oral solution.
11167030|NCT01976741|EG001|Reported Event|Rogaratinib Dose Expansion (All Comers)|Subjects with cancer types other than bladder cancer (BC), squamous cell carcinoma of the head and neck (SCCHN), and squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167031|NCT01976741|EG002|Reported Event|Rogaratinib Dose Expansion (BC)|Subjects with bladder cancer (BC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
10887857|NCT00503399|BG001|Baseline|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
11167032|NCT01976741|EG003|Reported Event|Rogaratinib Dose Expansion (SCCHN)|Subjects with squamous cell carcinoma of the head and neck (SCCHN) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167033|NCT01976741|EG004|Reported Event|Rogaratinib Dose Expansion (sqNSCLC)|Subjects with squamous non-small cell lung cancer (sqNSCLC) received 800 mg Rogaratinib oral tablet BID (1600 mg/day) in 21-days cycles.
11167034|NCT01976806|BG000|Baseline|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
11167035|NCT01976806|BG001|Baseline|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
11167036|NCT01976806|BG002|Baseline|Total|Total of all reporting groups
11167037|NCT01976806|FG000|Participant Flow|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
11230213|NCT02404389|OG000|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
11230214|NCT02404389|OG001|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
11230215|NCT02404389|OG002|Outcome|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications
11230216|NCT02404389|OG003|Outcome|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications
11230217|NCT02404389|OG004|Outcome|Aldara|Aldara cream 3 applications per week
11230218|NCT02404389|OG002|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
11230219|NCT02404389|OG003|Outcome|Aldara|Aldara cream 3 applications per week
11230220|NCT02404389|EG000|Reported Event|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
11230221|NCT02404389|EG001|Reported Event|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
11230222|NCT02404389|EG002|Reported Event|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications
11230223|NCT02404389|EG003|Reported Event|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications
11230224|NCT02404389|EG004|Reported Event|Aldara|Aldara cream 3 applications per week
11230225|NCT02404441|BG000|Baseline|1mg/kg q2w|Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
11230226|NCT02404441|BG001|Baseline|3mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
11230227|NCT02404441|BG002|Baseline|10mg/kg q2w|Phase I Dose escalation cohort patients who took PDR001 10 mg/kg q2w
11230228|NCT02404441|BG003|Baseline|3mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
11230229|NCT02404441|BG004|Baseline|5mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
11230230|NCT02404441|BG005|Baseline|NSCLC 400mg/q4w|Phase II: non-small cell cancer patients who took PDR001 400 mg/q4w
11230231|NCT02404441|BG006|Baseline|Melanoma 400mg/q4w|Phase II: Melanoma patients who took PDR001 400 mg/q4w
11230232|NCT02404441|BG007|Baseline|TNBC 400mg/q4w|Phase II: Triple negative breast cancer (TNBC) patients who took PDR001 400 mg/q4w
11230233|NCT02404441|BG008|Baseline|NSCLC 300mg/q3w|Phase II: non-small cell cancer patients who took PDR001 300 mg/q3w
11230234|NCT02404441|BG009|Baseline|ATC 400 mg/q4w|Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
11230235|NCT02404441|BG010|Baseline|Total|Total of all reporting groups
11230236|NCT02404441|FG000|Participant Flow|1mg/kg q2w|Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
11230237|NCT02404441|FG001|Participant Flow|3mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
11230238|NCT02404441|FG002|Participant Flow|10mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 10 mg/kg q2w
11230239|NCT02404441|FG003|Participant Flow|3mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
11230240|NCT02404441|FG004|Participant Flow|5mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
11230241|NCT02404441|FG005|Participant Flow|NSCLC 400mg/q4w|Phase II: non-small cell cancer patients who took PDR001 400 mg/q4w
11230242|NCT02404441|FG006|Participant Flow|Melanoma 400mg/q4w|Phase II: Melanoma patients who took PDR001 400 mg/q4w
11230243|NCT02404441|FG007|Participant Flow|TNBC 400mg/q4w|Phase II: Triple negative breast cancer (TNBC) patients who took PDR001 400 mg/q4w
11230244|NCT02404441|FG008|Participant Flow|NSCLC 300mg/q3w|Phase II: non-small cell cancer patients who took PDR001 300 mg/q3w
11230245|NCT02404441|FG009|Participant Flow|ATC 400 mg/q4w|Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
11351525|NCT03989570|OG001|Outcome|Group II (B Group)|"31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).~transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected"
11351526|NCT03989570|OG002|Outcome|Group III (C Group)|"31 patients anesthetized with the protocol followed by Minia University Hospital~control group: placebo"
11351527|NCT03989570|EG000|Reported Event|Group I (A Group)|"31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).~erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes"
11167038|NCT01976806|FG001|Participant Flow|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
11167039|NCT01976806|OG000|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
11167040|NCT01976806|OG001|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
11167041|NCT01976806|EG000|Reported Event|DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
11167042|NCT01976806|EG001|Reported Event|Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
11167043|NCT01976819|BG000|Baseline|TW Speaking Valve/HME|"Use of the TW speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve"
11167044|NCT01976819|FG000|Participant Flow|TW Speaking Valve/HME|"At baseline, participants were asked to complete a baseline questionnaire. After that, patients were asked to use both the current (old) TW15 or the TW22 for a week. After each week, patients completed a device specific questionnaire. At the end of the two week period, patients also completed a structured and comparative questionnaire.~Patients were then asked to use the new updated Speaking Valve for a week and then to complete relevant sections of the same questionnaire that was also used for the previous (old) device. Patients could decide again whether they wanted to participate in the long term part of the study, which will follow the same structure with the same questionnaires as in Stage 0."
11351528|NCT03989570|EG001|Reported Event|Group II (B Group)|"31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).~transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected"
11167045|NCT01976819|OG000|Outcome|Updated Speaking Valve/HME|"Use of the updated speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 combined."
11167046|NCT01976819|OG001|Outcome|Use of the Old HME Speaking Valve|Data from the use of the old HME speaking valve, data from TW15 and TW22 combined.
11167047|NCT01976819|OG000|Outcome|Use of Updated Speaking Valve|"Use of the TW speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 combined."
11167048|NCT01976819|OG001|Outcome|Use of Old Speaking Valve|Usage of the old speaking valve device. TW15 and TW22 combined.
11167049|NCT01976819|OG000|Outcome|Use of Updated Speaking Valve|"Use of the TW speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 are combined."
11167050|NCT01976819|OG001|Outcome|Use of Old Speaking Valve|Data from TW15 and 22 combined.
11167051|NCT01976819|EG000|Reported Event|TW Speaking Valve/HME|"Use of the TW speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve"
11167052|NCT01976845|BG000|Baseline|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
11167053|NCT01976845|BG001|Baseline|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
11167054|NCT01976845|BG002|Baseline|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
11167055|NCT01976845|BG003|Baseline|Total|Total of all reporting groups
11167056|NCT01976845|FG000|Participant Flow|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
11167057|NCT01976845|FG001|Participant Flow|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
11167058|NCT01976845|FG002|Participant Flow|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
11167059|NCT01976845|OG000|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
11167060|NCT01976845|OG001|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
11167061|NCT01976845|OG002|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
11167062|NCT01976845|EG000|Reported Event|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
11167063|NCT01976845|EG001|Reported Event|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
11167064|NCT01976845|EG002|Reported Event|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
11167065|NCT01976871|BG000|Baseline|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
11167066|NCT01976871|FG000|Participant Flow|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
11167067|NCT01976871|OG000|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
11167068|NCT01976871|EG000|Reported Event|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
11167069|NCT01976975|BG000|Baseline|Mood Disorder Patients|Patients with depressive and/or manic or hypomanic symptoms
11167070|NCT01976975|BG001|Baseline|Healthy Controls|Participants with no lifetime history of psychiatric illness
11167071|NCT01976975|BG002|Baseline|Total|Total of all reporting groups
11167072|NCT01976975|FG000|Participant Flow|Mood Disorder Patients|Patients with depressive and/or manic or hypomanic symptoms
11167073|NCT01976975|FG001|Participant Flow|Healthy Controls|Participants with no lifetime history of psychiatric illness
11167074|NCT01976975|OG000|Outcome|Mood Disorder Patients|Patients with depressive and/or manic or hypomanic symptoms
11167075|NCT01976975|OG001|Outcome|Healthy Controls|Participants with no lifetime history of psychiatric illness
11167076|NCT01976975|EG000|Reported Event|Mood Disorder Patients|Patients with depressive and/or manic or hypomanic symptoms
11167077|NCT01976975|EG001|Reported Event|Healthy Controls|Participants with no lifetime history of psychiatric illness
11167078|NCT01976988|BG000|Baseline|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
11167079|NCT01976988|BG001|Baseline|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
11167080|NCT01976988|BG002|Baseline|Total|Total of all reporting groups
11167081|NCT01976988|FG000|Participant Flow|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
11230246|NCT02404441|OG000|Outcome|1mg/kg q2w|Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
10887858|NCT00503399|BG002|Baseline|Total|Total of all reporting groups
10887859|NCT00503399|FG000|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
11351529|NCT03989570|EG002|Reported Event|Group III (C Group)|"31 patients anesthetized with the protocol followed by Minia University Hospital~control group: placebo"
11351530|NCT03988803|BG000|Baseline|BI 425809/Memantine/BI 425809+Memantine|Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1. Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 mL of water after an overnight fast of at least 10 hours once daily. Dose was up-titrated starting with one tablet of 5 mg for days 1-7, for days 8 -14 one tablet of 10 mg, for days 15-21 one tablet of 15 mg, for days 22 - 28 one tablet of 20 mg, and from days 29 - 35 of period 2 one tablet of 20 mg for period 2. Treatment Period 3 (Test (T)): Oral administration of 25 mg BI 425809 in combination with oral administration one tablet of 20 mg memantine with 240 mL of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 3. Periods 1 and 2 with a washout period of at least 7 days. Period 3 followed directly after Period 2.
11351531|NCT03988803|FG000|Participant Flow|BI 425809/Memantine/BI 425809+Memantine|Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1. Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 mL of water after an overnight fast of at least 10 hours once daily. Dose was up-titrated starting with one tablet of 5 mg for days 1-7, for days 8 -14 one tablet of 10 mg, for days 15-21 one tablet of 15 mg, for days 22 - 28 one tablet of 20 mg, and from days 29 - 35 of period 2 one tablet of 20 mg for period 2. Treatment Period 3 (Test (T)): Oral administration of 25 mg BI 425809 in combination with oral administration one tablet of 20 mg memantine with 240 mL of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 3. Periods 1 and 2 with a washout period of at least 7 days. Period 3 followed directly after Period 2.
11351532|NCT03988803|OG000|Outcome|BI 425809|Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1.
11351533|NCT03988803|OG001|Outcome|Memantine + BI 425809|Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) in combination with oral administration of 1 tablet of 20 mg Memantine with 240 milliliter (mL) of water after an overnight fast of at least 10 hours for days 1 - 10 of period 3.
11351534|NCT03988803|OG000|Outcome|Memantine|"Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily.~Memantine was up-titrated starting with one tablet of 5 mg for days 1-7 of period 2, for days 8 -14 of period 2 one tablet of 10 mg Memantine daily, for days 15-21 one tablet of 15 mg Memantine daily, for days 22 - 28 of period 2 one tablet of 20 mg daily, and from days 29 - 35 of period 2 one tablet of 20 mg daily."
11351535|NCT03988803|EG000|Reported Event|BI 425809|Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1.
11351536|NCT03988803|EG001|Reported Event|Memantine|"Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily.~Memantine was up-titrated starting with one tablet of 5 mg for days 1-7 of period 2, for days 8 -14 of period 2 one tablet of 10 mg Memantine daily, for days 15-21 one tablet of 15 mg Memantine daily, for days 22 - 28 of period 2 one tablet of 20 mg daily, and from days 29 - 35 of period 2 one tablet of 20 mg daily."
11351537|NCT03988803|EG002|Reported Event|Memantine + BI 425809|Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) in combination with oral administration of 1 tablet of 20 mg Memantine with 240 milliliter (mL) of water after an overnight fast of at least 10 hours for days 1 - 10 of period 3.
11351538|NCT03987932|BG000|Baseline|NEAT!2|"Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.~NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months."
11351539|NCT03987932|BG001|Baseline|NEAT!2+Calls|"Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.~NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls."
11351540|NCT03987932|BG002|Baseline|Delayed NEAT!2|"Participants will receive the NEAT!2 app to use between 3 and 6 months.~Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months."
11351541|NCT03987932|BG003|Baseline|Total|Total of all reporting groups
11357209|NCT03762681|BG007|Baseline|Part 2a, Arm 2: 0.4 mg/kg RO7239958|Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11357210|NCT03762681|BG008|Baseline|Total|Total of all reporting groups
11357211|NCT03762681|FG000|Participant Flow|Part 1, Cohorts 1-4: Placebo|Healthy volunteers were administered a single dose of placebo subcutaneously (SC).
11357212|NCT03762681|FG001|Participant Flow|Part 1, Cohort 1: 0.1 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC.
10887860|NCT00503399|FG001|Participant Flow|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
11351542|NCT03987932|FG000|Participant Flow|NEAT!2|"Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.~NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months."
11351543|NCT03987932|FG001|Participant Flow|NEAT!2+Calls|"Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.~NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls."
11351544|NCT03987932|FG002|Participant Flow|Delayed NEAT!2|"Participants will receive the NEAT!2 app to use between 3 and 6 months.~Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months."
11351545|NCT03987932|OG000|Outcome|NEAT!2|"Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.~NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months."
11351546|NCT03987932|OG001|Outcome|NEAT!2+Calls|"Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.~NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls."
11351547|NCT03987932|OG002|Outcome|Delayed NEAT!2|"Participants will receive the NEAT!2 app to use between 3 and 6 months.~Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months."
11351548|NCT03987932|EG000|Reported Event|NEAT!2|"Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.~NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months."
11351549|NCT03987932|EG001|Reported Event|NEAT!2+Calls|"Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.~NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls."
11351550|NCT03987932|EG002|Reported Event|Delayed NEAT!2|"Participants will receive the NEAT!2 app to use between 3 and 6 months.~Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months."
11351551|NCT03987191|BG000|Baseline|Standard of Care Transition|"Stopping of insulin pump on the day of randomization and starting insulin degludec in 1:1 ratio (same units as total basal insulin on pump) and insulin Aspart for meals and corrections~Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"
11351552|NCT03987191|BG001|Baseline|Investigational Transition|"Administration of insulin degludec in 1:1 ratio (same units as total basal insulin on pump) on the day of randomization AND concomitant use of the insulin pump for 48 hours from transition, where insulin pump basal rate will be reduced by 50% during the first 24 hours from transition and by 75% during 24 to 48 hours from transition. Insulin pump will be disconnected after 48 hours from transition~Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"
11351553|NCT03987191|BG002|Baseline|Total|Total of all reporting groups
11357213|NCT03762681|FG002|Participant Flow|Part 1, Cohort 2: 0.3 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC.
11357214|NCT03762681|FG003|Participant Flow|Part 1, Cohort 3: 1.0 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC.
10887861|NCT00503399|OG000|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
11351554|NCT03987191|FG000|Participant Flow|Standard of Care Transition|"Stopping of insulin pump on the day of randomization and starting insulin degludec in 1:1 ratio (same units as total basal insulin on pump) and insulin Aspart for meals and corrections~Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"
11351555|NCT03987191|FG001|Participant Flow|Investigational Transition|"Administration of insulin degludec in 1:1 ratio (same units as total basal insulin on pump) on the day of randomization AND concomitant use of the insulin pump for 48 hours from transition, where insulin pump basal rate will be reduced by 50% during the first 24 hours from transition and by 75% during 24 to 48 hours from transition. Insulin pump will be disconnected after 48 hours from transition~Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"
11351556|NCT03987191|OG000|Outcome|Standard of Care Transition|"Stopping of insulin pump on the day of randomization and starting insulin degludec in 1:1 ratio (same units as total basal insulin on pump) and insulin Aspart for meals and corrections~Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"
11351557|NCT03987191|OG001|Outcome|Investigational Transition|"Administration of insulin degludec in 1:1 ratio (same units as total basal insulin on pump) on the day of randomization AND concomitant use of the insulin pump for 48 hours from transition, where insulin pump basal rate will be reduced by 50% during the first 24 hours from transition and by 75% during 24 to 48 hours from transition. Insulin pump will be disconnected after 48 hours from transition~Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"
11351558|NCT03987191|EG000|Reported Event|Standard of Care Transition|"Stopping of insulin pump on the day of randomization and starting insulin degludec in 1:1 ratio (same units as total basal insulin on pump) and insulin Aspart for meals and corrections~Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"
11351559|NCT03987191|EG001|Reported Event|Investigational Transition|"Administration of insulin degludec in 1:1 ratio (same units as total basal insulin on pump) on the day of randomization AND concomitant use of the insulin pump for 48 hours from transition, where insulin pump basal rate will be reduced by 50% during the first 24 hours from transition and by 75% during 24 to 48 hours from transition. Insulin pump will be disconnected after 48 hours from transition~Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"
11351560|NCT03988842|BG000|Baseline|All Study Participants|"Participants were randomly assigned to either:~Alteplase & Unfractionated Heparin & Apixaban Alteplase 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Alteplase: Lyophilized powder for reconstitution in 50mg vials Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Apixaban: Apixaban tablet OR Placebo & Unfractionated Heparin & Apixaban Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Placebo: Saline solution reconstituted to mimic Alteplase 50mg vial Apixaban: Apixaban tablet"
11351561|NCT03988842|FG000|Participant Flow|All Study Participants|"Participants were randomly assigned to either:~Alteplase & Unfractionated Heparin & Apixaban~Alteplase 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Alteplase: Lyophilized powder for reconstitution in 50mg vials Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Apixaban: Apixaban tablet~OR~Placebo & Unfractionated Heparin & Apixaban~Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Placebo: Saline solution reconstituted to mimic Alteplase 50mg vial Apixaban: Apixaban tablet"
11351562|NCT03988842|OG000|Outcome|All Study Participants|"Participants were randomly assigned to either:~Alteplase & Unfractionated Heparin & Apixaban Alteplase 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Alteplase: Lyophilized powder for reconstitution in 50mg vials Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Apixaban: Apixaban tablet OR Placebo & Unfractionated Heparin & Apixaban Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Placebo: Saline solution reconstituted to mimic Alteplase 50mg vial Apixaban: Apixaban tablet"
11357215|NCT03762681|FG004|Participant Flow|Part 1, Cohort 4: 1.5 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC.
11357216|NCT03762681|FG005|Participant Flow|Part 2a: Placebo|Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W).
11357217|NCT03762681|FG006|Participant Flow|Part 2a, Arm 1: 0.2 mg/kg RO7239958|Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W.
10887862|NCT00503399|OG001|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
10887863|NCT00503399|EG000|Reported Event|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
11357218|NCT03762681|FG007|Participant Flow|Part 2a, Arm 2: 0.4 mg/kg RO7239958|Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11351563|NCT03988842|OG000|Outcome|All Study Participants|"Participants were randomly assigned to either:~Alteplase & Unfractionated Heparin & Apixaban~Alteplase 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Alteplase: Lyophilized powder for reconstitution in 50mg vials Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Apixaban: Apixaban tablet~OR~Placebo & Unfractionated Heparin & Apixaban~Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Placebo: Saline solution reconstituted to mimic Alteplase 50mg vial Apixaban: Apixaban tablet"
11351564|NCT03988842|EG000|Reported Event|All Study Participants|"Participants were randomly assigned to either:~Alteplase & Unfractionated Heparin & Apixaban Alteplase 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Alteplase: Lyophilized powder for reconstitution in 50mg vials Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Apixaban: Apixaban tablet OR Placebo & Unfractionated Heparin & Apixaban Alteplase placebo solution 24mg intravenous infusion for 20 minutes followed by unfractionated heparin intravenous infusion over 24 hours followed by apixaban 10mg tablet twice-daily for one week followed by apixaban 5mg tablet twice-daily for at least 6 months.~Unfractionated heparin: Heparin sodium in 0.45% sodium chloride injection for intravenous use Placebo: Saline solution reconstituted to mimic Alteplase 50mg vial Apixaban: Apixaban tablet"
11351565|NCT03981861|BG000|Baseline|Treatment|"Treatment with Metformin and Spironolactone~Metformin and Spironolactone: Oral Metformin tablet (500 mg/tablet) twice daily for 6 months. Oral Spironolactone tablet (50 mg/tablet) once daily for 6 months."
11351566|NCT03981861|FG000|Participant Flow|Overall Study|The pilot study was a non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
11351567|NCT03981861|OG000|Outcome|Overall Study|This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
11351568|NCT03981861|EG000|Reported Event|Overall Study|The pilot study was a non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
11351569|NCT03974334|BG000|Baseline|OWL-Hypertension 8 Wk Trial|"Two groups of thirteen participants will use the Our Whole Lives - Hypertension eHealth online tool for 8 weeks each, with baseline, midline, and follow-up data collected to determine any change due to the intervention.~OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes."
11351570|NCT03974334|FG000|Participant Flow|OWL-Hypertension 8 Wk Trial|"Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.~OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes."
11351571|NCT03974334|OG000|Outcome|OWL-Hypertension 8 Wk Trial|"Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.~OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes."
11351572|NCT03974334|EG000|Reported Event|OWL-Hypertension 8 Wk Trial|"Two cohorts of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention.~OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes."
11351573|NCT03988426|BG000|Baseline|All Patients|Full analysis set (FAS population) included all patients who received at least one administration of the study drug and for whom any post-baseline data was available
10887864|NCT00503399|EG001|Reported Event|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
11351574|NCT03988426|FG000|Participant Flow|Participants Administered Octanorm|All patients in the study received Octanorm as study drug. Dosage of octanorm was based on the previous dosage of IVIG for each patient: by dividing the previous IVIG dosage by the number of weeks between IVIG administrations. Octanorm was to be administered every week (+/- 2 days) as subcutaneous administration. Administration were either done at the study site (for the first training sessions and then every 4th infusions) or at home (administered by the patient or a caregiver)
11351575|NCT03988426|OG000|Outcome|Octanorm|Octanorm: Octanorm
11351576|NCT03988426|OG000|Outcome|All Patients|Full analysis set
11351577|NCT03988426|OG000|Outcome|Full Analysis Set|All participants who received at least 1 complete treatment with Octanorm and for whom any post-baseline data was available.
11351578|NCT03988426|EG000|Reported Event|Octanorm|Octanorm: Octanorm
11351579|NCT03988374|BG000|Baseline|0% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351580|NCT03988374|BG001|Baseline|20% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351581|NCT03988374|BG002|Baseline|35% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351582|NCT03988374|BG003|Baseline|Total|Total of all reporting groups
11351583|NCT03988374|FG000|Participant Flow|0% Baking Soda Dentifrice|Dentifrice, not containing baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use.
11351584|NCT03988374|FG001|Participant Flow|20% Baking Soda Dentifrice|Dentifrice, containing 20% baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use.
11351585|NCT03988374|FG002|Participant Flow|35% Baking Soda Dentifrice|Dentifrice, containing 35% baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use.
11351586|NCT03988374|OG000|Outcome|0% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351587|NCT03988374|OG001|Outcome|20% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351588|NCT03988374|OG002|Outcome|35% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351589|NCT03988374|EG000|Reported Event|0% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351590|NCT03988374|EG001|Reported Event|20% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351591|NCT03988374|EG002|Reported Event|35% Baking Soda Dentifrice|Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
11351592|NCT03987074|BG000|Baseline|Semaglutide|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
11351593|NCT03987074|BG001|Baseline|Semaglutide + Firsocostat 20 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
11351594|NCT03987074|BG002|Baseline|Semaglutide + Cilofexor 30 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
11351595|NCT03987074|BG003|Baseline|Semaglutide + Cilofexor 100 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
11351596|NCT03987074|BG004|Baseline|Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
11351597|NCT03987074|BG005|Baseline|Total|Total of all reporting groups
11351598|NCT03987074|FG000|Participant Flow|Semaglutide|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
11351599|NCT03987074|FG001|Participant Flow|Semaglutide + Firsocostat 20 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
11351600|NCT03987074|FG002|Participant Flow|Semaglutide + Cilofexor 30 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
11351601|NCT03987074|FG003|Participant Flow|Semaglutide + Cilofexor 100 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
11351602|NCT03987074|FG004|Participant Flow|Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
11351603|NCT03987074|OG000|Outcome|Semaglutide|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
11351604|NCT03987074|OG001|Outcome|Semaglutide + Firsocostat 20 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
11351605|NCT03987074|OG002|Outcome|Semaglutide + Cilofexor 30 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
11351606|NCT03987074|OG003|Outcome|Semaglutide + Cilofexor 100 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
11357219|NCT03762681|OG000|Outcome|Part 1, Cohorts 1-4: Placebo|Healthy volunteers were administered a single dose of placebo subcutaneously (SC).
11351607|NCT03987074|OG004|Outcome|Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
11351608|NCT03987074|EG000|Reported Event|Semaglutide|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
11351609|NCT03987074|EG001|Reported Event|Semaglutide + Firsocostat 20 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
11351610|NCT03987074|EG002|Reported Event|Semaglutide + Cilofexor 30 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
11351611|NCT03987074|EG003|Reported Event|Semaglutide + Cilofexor 100 mg|Semaglutide + Cilofexor 100 mg Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
11351612|NCT03987074|EG004|Reported Event|Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg|Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
11351613|NCT03977935|BG000|Baseline|The First-generation MCCG Group|"The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the 360-degree automatic scanning mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the small-bowel mode. The magnetic steering time for passing through the pylorus was not allowed more than 15 min."
11357220|NCT03762681|OG001|Outcome|Part 1, Cohort 1: 0.1 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC.
10887865|NCT00503425|BG000|Baseline|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
10887866|NCT00503425|FG000|Participant Flow|Rituximab|Participants received rituximab (MabThera) 1000 milligrams (mg) intravenous (IV) dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the European League Against Rheumatism (EULAR) response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
10887867|NCT00503425|OG000|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
10887868|NCT00503425|OG000|Outcome|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
10887869|NCT00503425|EG000|Reported Event|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
10887870|NCT00503685|BG000|Baseline|IMC-A12|Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10887871|NCT00503685|BG001|Baseline|IMC-A12 + Cetuximab|Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10887872|NCT00503685|BG002|Baseline|IMC-A12 + Cetuximab (K-ras Wild-type)|"Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.~Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent."
10887873|NCT00503685|BG003|Baseline|Total|Total of all reporting groups
10887874|NCT00503685|FG000|Participant Flow|IMC-A12|Participants received 10 milligrams/kilogram (mg/kg) IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10887875|NCT00503685|FG001|Participant Flow|IMC-A12 + Cetuximab|Participants received cetuximab 500 milligrams/square meter (mg/m²) intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10887876|NCT00503685|FG002|Participant Flow|IMC-A12 + Cetuximab (K-ras Wild-type)|"Participants with Kirsten rat sarcoma (K-ras) wild-type who experienced confirmed partial response (PR) or stable disease (SD) ≥ 24 weeks on a prior anti-epidermal growth factor receptor (EGFR)-containing therapy followed by disease progression were enrolled in this arm.~Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent."
10887877|NCT00503685|OG000|Outcome|IMC-A12|Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
11230247|NCT02404441|OG001|Outcome|3mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
11230248|NCT02404441|OG002|Outcome|10mg/kg q2w|Phase I Dose escalation cohort patients who took PDR001 10 mg/kg q2w
11230249|NCT02404441|OG003|Outcome|3mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
11230250|NCT02404441|OG004|Outcome|5mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
11230251|NCT02404441|OG000|Outcome|NSCLC 400 mg/q4w|Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
11230252|NCT02404441|OG001|Outcome|Melanoma 400 mg/q4w|Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
11230253|NCT02404441|OG002|Outcome|TNBC 400 mg/q4w|Patients in Phase II with TNBC who took PDR001 400 mg/q4w
11230254|NCT02404441|OG003|Outcome|NSCLC 300 mg/q3w|Patients in Phase II with non-small cell cancer who took PDR001 300 mg/q3w
11230255|NCT02404441|OG004|Outcome|ATC 400 mg/q4w|Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
11230256|NCT02404441|OG005|Outcome|All Phase II Patients|All patients in Phase II regardless of how they took PDR001
11230257|NCT02404441|OG003|Outcome|All Phase I q2w|Phase I dose Cohorts - All patients in Phase I who took PDR001 q2w
11230258|NCT02404441|OG004|Outcome|3mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
11230259|NCT02404441|OG005|Outcome|5mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
11230260|NCT02404441|OG006|Outcome|All Phase I q4w|Phase I dose Cohorts - All patients in Phase I who took PDR001 q4w
11230261|NCT02404441|OG007|Outcome|All Phase I Patients|All patients in Phase I regardless of how they took PDR001
11230262|NCT02404441|OG000|Outcome|3mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
11230263|NCT02404441|OG001|Outcome|10mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 10 mg/kg q2w
11230264|NCT02404441|OG002|Outcome|All Phase I q2w|Phase I dose Cohorts - All patients in Phase I who took PDR001 q2w
11230265|NCT02404441|OG003|Outcome|All Phase I Patients|All patients in Phase I regardless of how they took PDR001
11230266|NCT02404441|OG002|Outcome|10mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 10 mg/kg q2w
11230267|NCT02404441|OG002|Outcome|NSCLC 300 mg/q3w|Patients in Phase II with non-small cell cancer who took PDR001 300 mg/q3w
11230268|NCT02404441|OG003|Outcome|ATC 400 mg/q4w|Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
11230269|NCT02404441|OG005|Outcome|NSCLC 400 mg/q4w|Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
11230270|NCT02404441|OG006|Outcome|Melanoma 400 mg/q4w|Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
11230271|NCT02404441|OG007|Outcome|TNBC 400 mg/q4w|Patients in Phase II with TNBC who took PDR001 400 mg/q4w
11230272|NCT02404441|OG008|Outcome|NSCLC 300 mg/q3w|Patients in Phase II with non-small cell cancer who took PDR001 300 mg/q3w
11230273|NCT02404441|OG009|Outcome|ATC 400 mg/q4w|Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
11230274|NCT02404441|EG000|Reported Event|1mg/kg q2w|Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
11230275|NCT02404441|EG001|Reported Event|3mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
11230276|NCT02404441|EG002|Reported Event|10mg/kg q2w|Phase I Dose escalation cohort patients who took PRD001 10 mg/kg q2w
11230277|NCT02404441|EG003|Reported Event|All Phase I q2w|Phase I dose Cohorts - All patients in Phase I who took PDR001 q2w
11230278|NCT02404441|EG004|Reported Event|3mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
11230279|NCT02404441|EG005|Reported Event|5mg/kg q4w|Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
11230280|NCT02404441|EG006|Reported Event|All Phase I q4w|Phase I dose Cohorts - All patients in Phase I who took PDR001 q4w
11230281|NCT02404441|EG007|Reported Event|All Phase I Patients|All patients in Phase I regardless of how they took PDR001
11230282|NCT02404441|EG008|Reported Event|NSCLC 400mg/q4w|Phase II: non-small cell cancer patients who took PDR001 400 mg/q4w
11230283|NCT02404441|EG009|Reported Event|Melanoma 400mg/q4w|Phase II: Melanoma patients who took PDR001 400 mg/q4w
11230284|NCT02404441|EG010|Reported Event|TNBC 400mg/q4w|Phase II: Triple negative breast cancer (TNBC) patients who took PDR001 400 mg/q4w
11230285|NCT02404441|EG011|Reported Event|NSCLC 300mg/q3w|Phase II: non-small cell cancer patients who took PDR001 300 mg/q3w
11230286|NCT02404441|EG012|Reported Event|ATC 400 mg/q4w|Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
11230287|NCT02404441|EG013|Reported Event|All Phase II Patients|All patients in Phase II regardless of how they took PDR001
11230288|NCT02404493|BG000|Baseline|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
11230289|NCT02404493|BG001|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
11230290|NCT02404493|BG002|Baseline|Total|Total of all reporting groups
11230291|NCT02404493|FG000|Participant Flow|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
11230292|NCT02404493|FG001|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
11230293|NCT02404493|OG000|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
11230294|NCT02404493|OG001|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
11230295|NCT02404493|EG000|Reported Event|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
10887878|NCT00503685|OG001|Outcome|IMC-A12 + Cetuximab|Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10887879|NCT00503685|OG002|Outcome|IMC-A12 + Cetuximab (K-ras Wild-type)|"Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.~Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent."
11230296|NCT02404493|EG001|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
11230297|NCT02404532|BG000|Baseline|MIND1 System IEM Detection (All Enrolled Participants)|On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device [eg, smartphone] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smart phone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone).
11230298|NCT02404532|FG000|Participant Flow|MIND1 System IEM Detection (All Enrolled Participants)|On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device [eg, smart phone] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded ingestible event marker (IEM) tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by the medical information device #1 (MIND1) system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smart phone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smart phone).
11230299|NCT02404532|OG000|Outcome|MIND1 System IEM Detection (All Enrolled Participants)|On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device [eg, smartphone] application) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time that was detected by the MIND1 system compatible computing device (eg, smartphone).
11230300|NCT02404532|OG000|Outcome|Patch Acquisition of IEM to MDDS|The information transmission - Patch Acquisition of IEM to MDDS was measured at all four time points (Hour 0, 2, 4 and 6)
11230301|NCT02404532|OG001|Outcome|MDDS to Otsuka Software Application Registration|The information transmission - MDDS to Otsuka software application registration was measured at all four time points (Hour 0, 2, 4 and 6)
11230302|NCT02404532|OG002|Outcome|Otsuka Software Application Registration to Cloud Server|The information transmission - Otsuka software application registration to Cloud Server was measured at all four time points (Hour 0, 2, 4 and 6)
11230303|NCT02404532|OG003|Outcome|Patch Acquisition of IEM to Cloud Server|The information transmission - Patch acquisition of IEM to Cloud Server was measures at all four time points (Hour 0, 2, 4 and 6)
11230304|NCT02404532|OG000|Outcome|MIND1 System IEM Detection (All Enrolled Participants)|On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device [eg, smartphone] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone).
11230305|NCT02404532|EG000|Reported Event|MIND1 System IEM Detection (All Enrolled Participants)|On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device [eg, smartphone] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone).
11230306|NCT02404610|BG000|Baseline|Moderate Procedural Sedation|"Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate.~Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.~propofol"
11351614|NCT03977935|BG001|Baseline|The Second-generation MCCG Group|"All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.~the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2)."
11351615|NCT03977935|BG002|Baseline|Total|Total of all reporting groups
11351616|NCT03977935|FG000|Participant Flow|The First-generation MCCG Group|"The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the 360-degree automatic scanning mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the small-bowel mode. The magnetic steering time for passing through the pylorus was not allowed more than 15 min."
11351617|NCT03977935|FG001|Participant Flow|The Second-generation MCCG Group|"All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.~the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2)."
11351618|NCT03977935|OG000|Outcome|The First-generation MCCG Group|"The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the 360-degree automatic scanning mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the small-bowel mode. The magnetic steering time for passing through the pylorus was not allowed more than 15 min."
11351619|NCT03977935|OG001|Outcome|The Second-generation MCCG Group|"All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.~the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2)."
11351620|NCT03977935|EG000|Reported Event|The First-generation MCCG Group|"The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the 360-degree automatic scanning mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the small-bowel mode. The magnetic steering time for passing through the pylorus was not allowed more than 15 min."
11351621|NCT03977935|EG001|Reported Event|The Second-generation MCCG Group|"All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.~the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2)."
11351622|NCT03988049|BG000|Baseline|1,550 Laser|"All subjects on this arm will be treated on this split-faced. This arm consists of the half-faces treated with the 1,550-nanometer Fracionated Photothermolysis laser.~1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser."
11351623|NCT03988049|BG001|Baseline|755 Laser|"All subjects on this arm will be treated on this split-faced. This arm consists of the half-faces treated with the 755-nanometer alexandrite picosecond laser.~1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser."
11351624|NCT03988049|BG002|Baseline|Total|Total of all reporting groups
11351625|NCT03988049|FG000|Participant Flow|1,550 Laser|"All subjects on this arm will be treated on this split-faced. This arm is looking at the side of the face treated with the 1,550-nanometer Fracionated Photothermolysis laser.~1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser."
11351626|NCT03988049|FG001|Participant Flow|755 Laser|"All subjects on this arm will be treated on this split-faced. This arm is the side of their face will be treated with the 755-nanometer alexandrite picosecond laser.~1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser."
11351627|NCT03988049|OG000|Outcome|1,550 Laser|"All subjects on this arm will be treated on this split-faced. This arm is looking at the side of the face treated with the 1,550-nanometer Fracionated Photothermolysis laser.~1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser."
11351628|NCT03988049|OG001|Outcome|755 Laser|"All subjects on this arm will be treated on this split-faced. This arm is the side of their face will be treated with the 755-nanometer alexandrite picosecond laser.~1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser."
11351629|NCT03988049|EG000|Reported Event|1,550 Laser|"This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser.~1,550 fracionated photothermolysis laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser."
11351630|NCT03988049|EG001|Reported Event|755 Laser|"This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser.~755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser."
11230307|NCT02404610|BG001|Baseline|Deep Procedural Sedation|"Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep.~Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.~propofol"
11230308|NCT02404610|BG002|Baseline|Total|Total of all reporting groups
11230309|NCT02404610|FG000|Participant Flow|Moderate Procedural Sedation|"Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate.~Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.~propofol"
11230310|NCT02404610|FG001|Participant Flow|Deep Procedural Sedation|"Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep.~Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.~propofol"
11230311|NCT02404610|OG000|Outcome|Moderate Procedural Sedation|"Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate.~Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.~propofol"
11230312|NCT02404610|OG001|Outcome|Deep Procedural Sedation|"Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep.~Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.~propofol"
11230313|NCT02404610|EG000|Reported Event|Moderate Procedural Sedation|"Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate.~Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.~propofol"
11230314|NCT02404610|EG001|Reported Event|Deep Procedural Sedation|"Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep.~Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.~propofol"
11230315|NCT02404649|BG000|Baseline|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
11230316|NCT02404649|BG001|Baseline|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
11230317|NCT02404649|BG002|Baseline|Total|Total of all reporting groups
11230318|NCT02404649|FG000|Participant Flow|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
11233931|NCT02431559|EG000|Reported Event|Phase 1, Dose Level 0a|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W [equivalent to 450 mg Q4W] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
11351631|NCT03979820|BG000|Baseline|Placebo/Placebo + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of placebo matching BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 were administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual participant had attained TYR30 on treatment.
11351632|NCT03979820|BG001|Baseline|Phenelzine/Phenelzine + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 8 to Day 19) following multiple doses of phenelzine sulfate (Nardil®). During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. 1 film-coated tablet of 15 mg of phenelzine sulfate was administered twice daily (daily dosage: 30 mg) from Day 1 to Day 18 and once daily (daily dosage: 15 mg) on Day 19 orally with 240 ml of water. Treatment with phenelzine sulfate was stopped as soon as the individual participant attained TYR30 on treatment.
11351633|NCT03979820|BG002|Baseline|10 mg BI 1467335/10 mg BI 1467335 + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 10 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was stopped as soon as the individual participant attained TYR30 on treatment.
11351634|NCT03979820|BG003|Baseline|15 mg BI 1467335/15 mg BI 1467335 + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. Participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 3 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was to be stopped as soon as the individual participant attained TYR30 on treatment.
11351635|NCT03979820|BG004|Baseline|Total|Total of all reporting groups
11351636|NCT03979820|FG000|Participant Flow|Placebo/Placebo + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of placebo matching BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 were administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual participant had attained TYR30 on treatment.
11351637|NCT03979820|FG001|Participant Flow|Phenelzine/Phenelzine + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 8 to Day 19) following multiple doses of phenelzine sulfate (Nardil®). During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. 1 film-coated tablet of 15 mg of phenelzine sulfate was administered twice daily (daily dosage: 30 mg) from Day 1 to Day 18 and once daily (daily dosage: 15 mg) on Day 19 orally with 240 ml of water. Treatment with phenelzine sulfate was stopped as soon as the individual participant attained TYR30 on treatment.
11357221|NCT03762681|OG002|Outcome|Part 1, Cohort 2: 0.3 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC.
11230319|NCT02404649|FG001|Participant Flow|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
11230320|NCT02404649|OG000|Outcome|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
11230321|NCT02404649|OG001|Outcome|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
11230322|NCT02404649|EG000|Reported Event|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
11230323|NCT02404649|EG001|Reported Event|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
11230324|NCT02404792|BG000|Baseline|HIV-Uninfected Controls|"All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL.~At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks."
11230325|NCT02404792|BG001|Baseline|Participants With HIV|"All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL.~At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks."
11230326|NCT02404792|BG002|Baseline|Total|Total of all reporting groups
11233932|NCT02431559|EG001|Reported Event|Phase 1, Dose Level 0b|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
11357222|NCT03762681|OG003|Outcome|Part 1, Cohort 3: 1.0 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC.
11357223|NCT03762681|OG004|Outcome|Part 1, Cohort 4: 1.5 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC.
11167082|NCT01976988|FG001|Participant Flow|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
11167083|NCT01976988|OG000|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
11167084|NCT01976988|OG001|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
11167085|NCT01976988|OG000|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
11167086|NCT01976988|OG001|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
11167087|NCT01976988|EG000|Reported Event|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
11167088|NCT01976988|EG001|Reported Event|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
11167089|NCT01977040|BG000|Baseline|Vasa Previa|Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012.
11167090|NCT01977040|FG000|Participant Flow|Vasa Previa|Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012.
11167091|NCT01977040|OG000|Outcome|Vasa Previa|Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012.
11357224|NCT03762681|OG005|Outcome|Part 2a: Placebo|Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W).
11167092|NCT01977040|OG000|Outcome|Emergent Cesarean Section|Cesarean Section prompted by a medical emergency.
11167093|NCT01977040|OG001|Outcome|Non-Emergent Cesarean Section|Cesarean Section planned or non-emergency related.
11167094|NCT01977040|OG002|Outcome|Vaginal Delivery|Delivered vaginally.
11167095|NCT01977040|OG001|Outcome|Non-Emergent Cesarean Section and Vaginal Delivery|Cesarean Section planned or non-emergency related and Vaginal Deliveries were included in this data
11167096|NCT01977040|EG000|Reported Event|Vasa Previa|"Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012.~All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed"
11167097|NCT01977092|BG000|Baseline|Motivational Interviewing Case Management|"MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).~Motivational interviewing case management"
11167098|NCT01977092|BG001|Baseline|Control - Resource Referrals|"Respondents will receive sober living house services as usual along with a list of resources that can be used to address a variety of problems.~control - Resource referrals"
11167099|NCT01977092|BG002|Baseline|Total|Total of all reporting groups
11167100|NCT01977092|FG000|Participant Flow|Motivational Interviewing Case Management|"MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).~Motivational interviewing case management"
11167101|NCT01977092|FG001|Participant Flow|Resource Referrals|"Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.~Resource referrals"
11167102|NCT01977092|OG000|Outcome|Motivational Interviewing Case Management|"MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).~Motivational interviewing case management"
11167103|NCT01977092|OG001|Outcome|Control/Resource Referrals|"Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.~Resource referrals"
11167104|NCT01977092|EG000|Reported Event|Motivational Interviewing Case Management|"MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).~Motivational interviewing case management"
11167105|NCT01977092|EG001|Reported Event|Resource Referrals|"Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.~Resource referrals"
11167106|NCT01977222|BG000|Baseline|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
11167107|NCT01977222|FG000|Participant Flow|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
11167108|NCT01977222|OG000|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
11167109|NCT01977222|EG000|Reported Event|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
11167110|NCT01977352|BG000|Baseline|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
11167111|NCT01977352|BG001|Baseline|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
11167112|NCT01977352|BG002|Baseline|Total|Total of all reporting groups
11167113|NCT01977352|FG000|Participant Flow|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
11167114|NCT01977352|FG001|Participant Flow|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
11167115|NCT01977352|OG000|Outcome|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
11167116|NCT01977352|OG001|Outcome|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
11167117|NCT01977352|EG000|Reported Event|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
11167118|NCT01977352|EG001|Reported Event|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
11167119|NCT01977456|BG000|Baseline|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
11167120|NCT01977456|FG000|Participant Flow|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
11167121|NCT01977456|OG000|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
11167122|NCT01977456|EG000|Reported Event|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
11167123|NCT01977482|BG000|Baseline|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167124|NCT01977482|BG001|Baseline|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11357225|NCT03762681|OG006|Outcome|Part 2a, Arm 1: 0.2 mg/kg RO7239958|Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11230327|NCT02404792|FG000|Participant Flow|Participants With HIV|All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
11230328|NCT02404792|FG001|Participant Flow|HIV-Uninfected Controls|All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded.At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
11230329|NCT02404792|OG000|Outcome|HIV-uninfected Controls|"All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL.~At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks."
11230330|NCT02404792|OG001|Outcome|Participants With HIV|"All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL.~At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks."
11230331|NCT02404792|OG000|Outcome|Participants With HIV|All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
11230332|NCT02404792|OG001|Outcome|HIV-Uninfected Controls|All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded.At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
11230333|NCT02404792|EG000|Reported Event|HIV-uninfected Controls|"All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL.~At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks."
11233933|NCT02431559|EG002|Reported Event|Phase 1, Dose Level +1|Subjects received PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
11233934|NCT02431559|EG003|Reported Event|Phase 2|Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
11351638|NCT03979820|FG002|Participant Flow|10 mg BI 1467335/10 mg BI 1467335 + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 10 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was stopped as soon as the individual participant attained TYR30 on treatment.
11351639|NCT03979820|FG003|Participant Flow|15 mg BI 1467335/15 mg BI 1467335 + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. Participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 3 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was to be stopped as soon as the individual participant attained TYR30 on treatment.
11351640|NCT03979820|OG000|Outcome|Placebo/Placebo + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of placebo matching BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 were administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual participant had attained TYR30 on treatment.
11351641|NCT03979820|OG001|Outcome|Phenelzine/Phenelzine + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 8 to Day 19) following multiple doses of phenelzine sulfate (Nardil®). During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. 1 film-coated tablet of 15 mg of phenelzine sulfate was administered twice daily (daily dosage: 30 mg) from Day 1 to Day 18 and once daily (daily dosage: 15 mg) on Day 19 orally with 240 ml of water. Treatment with phenelzine sulfate was stopped as soon as the individual participant attained TYR30 on treatment.
11351642|NCT03979820|OG002|Outcome|10 mg BI 1467335/10 mg BI 1467335 + Tyramine|Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 10 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was stopped as soon as the individual participant attained TYR30 on treatment.
11351643|NCT03979820|EG000|Reported Event|Tyramine Screening|As part of the screening procedure, participants were challenged (tyramine screening/baseline challenge) from Day -11 up to Day -2 with escalating oral doses of tyramine. Planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, 700 mg given once daily orally with 240 ml of water. In each individual participant, the tyramine dose escalation was stopped when SBP increased ≥30 mmHg in at least 3 consecutive measurements (TYR30). Participants who did not attain the predefined systolic BP target elevation within 4 h after 700 mg tyramine were not to be included in the trial.
11351644|NCT03979820|EG001|Reported Event|Placebo|From Day 1 to Day 28 participants received once daily 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water.
11351645|NCT03979820|EG002|Reported Event|Phenelzine|From Day 1 to Day 7 participants received 1 film-coated tablet of 15 mg of phenelzine sulfate administered twice daily (daily dosage: 30 mg) orally with 240 ml of water.
11351646|NCT03979820|EG003|Reported Event|10 mg BI 1467335|From Day 1 to Day 28 participants received 2 film-coated tablets of 5 mg of BI 1467335 administered once daily (daily dosage:10 mg) orally with 240 ml of water.
11351647|NCT03979820|EG004|Reported Event|15 mg BI 1467335|From Day 1 to Day 28 participants received 3 film-coated tablets of 5mg of BI 1467335 administered once daily (daily dosage: 15 mg) orally with 240 ml of water.
11230334|NCT02404792|EG001|Reported Event|Participants With HIV|"All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL.~At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks."
11230335|NCT02404805|BG000|Baseline|Sequence 1a|"Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230336|NCT02404805|BG001|Baseline|Sequence 1b|"Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230337|NCT02404805|BG002|Baseline|Sequence 2a|"Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230338|NCT02404805|BG003|Baseline|Sequence 2b|"Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230339|NCT02404805|BG004|Baseline|Sequence 3a|"Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230340|NCT02404805|BG005|Baseline|Sequence 3b|"Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230341|NCT02404805|BG006|Baseline|Total|Total of all reporting groups
11230342|NCT02404805|FG000|Participant Flow|Sequence 1a|"Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230343|NCT02404805|FG001|Participant Flow|Sequence 1b|"Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230344|NCT02404805|FG002|Participant Flow|Sequence 2a|"Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230345|NCT02404805|FG003|Participant Flow|Sequence 2b|"Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230346|NCT02404805|FG004|Participant Flow|Sequence 3a|"Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230347|NCT02404805|FG005|Participant Flow|Sequence 3b|"Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.~dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.~simeprevir: simeprevir tablets 150mg, once daily x 7 days."
11230348|NCT02404805|OG000|Outcome|Simeprevir Administered Alone|simeprevir: simeprevir tablets 150mg, once daily x 7 days.
11230349|NCT02404805|OG001|Outcome|Simeprevir and Dolutegravier Co-administered|"Dolutegravir and simeprevir together:~dolutegravir tablets 50mg, once daily and simeprevir tablets 150mg, once daily x 7 days."
11230350|NCT02404805|OG000|Outcome|Dolutegravir Administered Alone|dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.
11230351|NCT02404805|OG001|Outcome|Simeprevir and Dolutegravier Co-administered|"Dolutegravir and simeprevir co-administered:~dolutegravir tablets 50mg, once daily and simeprevir tablets 150mg, once daily x 7 da"
11230352|NCT02404805|EG000|Reported Event|Simeprevir Only|Simeprevir tablets 150mg, once daily x 7 days.
11230353|NCT02404805|EG001|Reported Event|Dolutegravir Only|Dolutegravir tablets 50mg, once daily x 7 days.
11230354|NCT02404805|EG002|Reported Event|Dolutegravir and Simeprevir Co-administered:|"Dolutegravir and simeprevir co-administered:~dolutegravir tablets 50mg, once daily, and simeprevir tablets 150mg, once daily, x 7 days"
11230355|NCT02405091|BG000|Baseline|Valbenazine 40mg|Participants received valbenazine 40mg once daily for up to 48 weeks.
11230356|NCT02405091|BG001|Baseline|Valbenazine 80mg|Participants received valbenazine 40mg once daily for 4 weeks, then 80mg once daily for up to 44 weeks.
11230357|NCT02405091|BG002|Baseline|Valbenazine 80/40mg|Participants received valbenazine 40mg once daily for 4 weeks, then 80 mg. Participants who were unable to tolerate the 80 mg dose had a dose decrease to 40 mg capsule once daily for up to 44 weeks.
11357226|NCT03762681|OG007|Outcome|Part 2a, Arm 2: 0.4 mg/kg RO7239958|Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11230358|NCT02405091|BG003|Baseline|Total|Total of all reporting groups
11230359|NCT02405091|FG000|Participant Flow|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for up to 48 weeks.
11230360|NCT02405091|FG001|Participant Flow|Valbenazine 80mg|Participants received valbenazine 40mg once daily for 4 weeks, then 80mg once daily for up to 44 weeks.
11230361|NCT02405091|FG002|Participant Flow|Valbenazine 80/40mg|Participants received valbenazine 40mg once daily for 4 weeks, then 80 mg. Participants who were unable to tolerate the 80 mg dose had a dose decrease to 40 mg capsule once daily for up to 44 weeks.
11230362|NCT02405091|OG000|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg once daily for up to 48 weeks.
11230363|NCT02405091|OG001|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg once daily for 4 weeks, then 80mg once daily for up to 44 weeks.
11351648|NCT03979820|EG005|Reported Event|Placebo + Tyramine|Participants received from Day 29 up to Day 39 concomitant medication of 2 0r 3 film-coated tablets of 5 mg of placebo matching BI 1467335 administered once daily (daily dosage:10 or 15mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual subject had attained TYR30 on treatment.
11351649|NCT03979820|EG006|Reported Event|Phenelzine + Tyramine|Participants received from Day 8 up to Day 19 concomitant medication of 1 film-coated tablets of 15 mg of phenelzine sulfate (Nardil®) administered twice daily from Day 8 up to Day 18 (daily dosage: 30 mg) and once daily on Day 19 (daily dosage: 15 mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. Treatment with phenelzine sulfate was stopped as soon as the individual subject attained TYR30 on treatment.
11351650|NCT03979820|EG007|Reported Event|10 mg BI 1467335 + Tyramine|Participants received from Day 29 up to Day 39 concomitant medication of 2 film-coated tablets of 5mg of BI 1467335 administered once daily (total dosage: 10 mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Treatment with BI 1467335 was stopped as soon as the individual subject attained TYR30 on treatment.
11351651|NCT03979820|EG008|Reported Event|15 mg BI 1467335 + Tyramine|Participants received from Day 29 up to Day 39 concomitant medication of 3 film-coated tablets of 5 mg of BI 1467335 administered once daily (daily dosage 15mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Treatment with BI 1467335 was to be stopped as soon as the individual subject had attained TYR30 on treatment.
11351652|NCT03972137|BG000|Baseline|Enrolled|Participants who were eligible and completed the Baseline session
11351653|NCT03972137|FG000|Participant Flow|Heart Rate Variability Biofeedback- Smoking Cessation Therapy|"All participants in this open trial received individualized cognitive-behavioral smoking cessation treatment, up to 8 weeks of the transdermal nicotine patch, and individualized heart rate variability biofeedback.~Cognitive-Behavioral Smoking Cessation: Participants were provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.~Heart Rate Variability Biofeedback: All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.~Nicotine patch: All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date."
11351654|NCT03972137|OG000|Outcome|Intent-to-treat (ITT)|Participants who completed their baseline session and were enrolled in the study
11351655|NCT03972137|OG001|Outcome|Remained in Treatment Beyond One Session|Excluding n=3 participants who withdrew following one intervention session.
11351656|NCT03972137|OG000|Outcome|First Session|Participants who attended their first intervention session
11351657|NCT03972137|OG001|Outcome|3-month Follow-up (3MFU)|Participants who attended their 3-month follow-up session
11351658|NCT03972137|OG001|Outcome|3-month Follow-up (3MFU)|Participants that attended their 3-month follow-up session
11351659|NCT03972137|OG000|Outcome|Quit Date|Participants who attended their Quit day session
11351660|NCT03972137|OG000|Outcome|Baseline (BL)|Mean CPD at baseline was determined by averaging the total number of cigarettes smoked per day for 30 the days prior to the participant's baseline session. Data reflect participants who attended their baseline session.
11351661|NCT03972137|OG001|Outcome|Quit Date|Mean CPD at Quit date was determined by averaging the total number of cigarettes smoked on their Quit-day session. Data reflect participants who attended their Quit-day session.
11351662|NCT03972137|OG002|Outcome|3-month Follow-up (3MFU)|Mean CPD at 3-Month Follow-up was determined by averaging the total number of cigarettes smoked during the 7 days prior to their 3MFU session. Data reflect participants who attended their 3MFU session.
11351663|NCT03972137|OG000|Outcome|Baseline (BL)|Participants who attended their baseline session
11351664|NCT03972137|OG001|Outcome|2-weeks Post-quit (2W)|Participants who attended their 2-weeks post-quit session
11351665|NCT03972137|OG002|Outcome|1-month Post-quit (1M)|Participants who attended their 1-month post-quit session
11351666|NCT03972137|OG003|Outcome|3-month Follow-up (3MFU)|Participants who attended their 3-month follow-up session
11351667|NCT03972137|EG000|Reported Event|Enrolled|Participants who were eligible and completed the baseline session
11351668|NCT03970395|BG000|Baseline|Osteopathic Manipulative Therapy Plus Repositioning Therapy|"Participants with Nonsynostic Plagiocephaly, Oblique Diameter Difference Index (ODDI )score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).~They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.~Repositioning therapy: It consists of strategies that guide the parents to position the baby back to sleep."
11351669|NCT03970395|BG001|Baseline|Light Touch Therapy Plus Repositioning Therapy|"Participants with Nonsynostic Plagiocephaly, Oblique Diameter Difference Index (ODDI) score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).~They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.~Repositioning therapy: It consists of strategies that guide the parents to position the baby back to sleep."
11351670|NCT03970395|BG002|Baseline|Total|Total of all reporting groups
11351671|NCT03970395|FG000|Participant Flow|Osteopathic Manipulative Therapy Plus Repositioning Therapy|"Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).~They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.~The intervention were performed by two osteopath with specific background in paediatric field.~Repositioning therapy: It consists of strategies that guide the parents to position the baby back to sleep."
11351672|NCT03970395|FG001|Participant Flow|Light Touch Therapy Plus Repositioning Therapy|"Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).~They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.~The intervention were performed by two osteopath with specific background in paediatric field.~Repositioning therapy: It consists of strategies that guide the parents to position the baby back to sleep."
11351673|NCT03970395|OG000|Outcome|Osteopathic Manipulative Therapy Plus Repositioning Therapy|"Participants received Osteopathic Manipulative Therapy (OMTh) plus Repositioning Therapy.~OMTh: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks."
11351674|NCT03970395|OG001|Outcome|Light Touch Therapy Plus Repositioning Therapy|Participants received Light Touch Therapy (LTT) plus Repositioning Therapy. LTT: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.
11351675|NCT03970395|OG000|Outcome|Osteopathic Manipulative Therapy Plus Repositioning Therapy|"Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).~They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.~The intervention were performed by two osteopaths with specific background in paediatric field.~Repositioning therapy: It consists of strategies that guide the parents to position the baby back to sleep."
11351676|NCT03970395|OG001|Outcome|Light Touch Therapy Plus Repositioning Therapy|"Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).~They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.~The intervention were performed by two osteopaths with specific background in paediatric field.~Repositioning therapy: It consists of strategies that guide the parents to position the baby back to sleep."
11351677|NCT03970395|OG000|Outcome|Osteopathic Manipulative Therapy Plus Repositioning Therapy|"Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).~They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.~The intervention were performed by two osteopaths with a specific background in paediatric field.~Repositioning therapy: It consists of strategies that guide the parents to position the baby back to sleep."
11351678|NCT03970395|OG001|Outcome|Light Touch Therapy Plus Repositioning Therapy|"Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).~They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.~The intervention was performed by two osteopaths with a specific background in paediatric field.~Repositioning therapy: It consists of strategies that guide the parents to position the baby back to sleep."
11351679|NCT03970395|EG000|Reported Event|Osteopathic Manipulative Therapy Plus Repositioning Therapy|"Participants received Osteopathic Manipulative Therapy (OMTh) plus Repositioning Therapy.~OMTh: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks."
11351680|NCT03970395|EG001|Reported Event|Light Touch Therapy Plus Repositioning Therapy|Participants received Light Touch Therapy (LTT) plus Repositioning Therapy. LTT: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.
11351681|NCT03987620|BG000|Baseline|Ibrexafungerp (SCY-078)|"300 mg BID for one day~Ibrexafungerp: Ibrexafungerp 300mg BID for one day"
11351682|NCT03987620|BG001|Baseline|Placebo|"Matching Placebo~Placebo: Matching Placebo"
11351683|NCT03987620|BG002|Baseline|Total|Total of all reporting groups
11351684|NCT03987620|FG000|Participant Flow|Ibrexafungerp (SCY-078)|"300 mg BID for one day~Ibrexafungerp: Ibrexafungerp 300mg BID for one day"
11351685|NCT03987620|FG001|Participant Flow|Placebo|"Matching Placebo~Placebo: Matching Placebo"
11351686|NCT03987620|OG000|Outcome|Ibrexafungerp (SCY-078)|"300 mg BID for one day~Ibrexafungerp: Ibrexafungerp 300mg BID for one day"
11351687|NCT03987620|OG001|Outcome|Placebo|"Matching Placebo~Placebo: Matching Placebo"
11351688|NCT03987620|EG000|Reported Event|Ibrexafungerp (SCY-078)|"300 mg BID for one day~Ibrexafungerp: Ibrexafungerp 300mg BID for one day"
11351689|NCT03987620|EG001|Reported Event|Placebo|"Matching Placebo~Placebo: Matching Placebo"
11351690|NCT03983317|BG000|Baseline|Active Treatment|"For the first week of the study, participants did not administer treatment with the Empower device. In this one-week Baseline Phase, participants only completed surveys to establish baseline values. In the final two weeks of the study, participants self-administered treatment with the Empower device two times daily. Participants completed surveys over the two-week period to evaluate the effects of the Empower treatment.~Empower Neuromodulation System: Transcutaneous electrical nerve stimulation"
11351691|NCT03983317|FG000|Participant Flow|Active Treatment|"For the first week of the study, participants did not administer treatment with the Empower device. In this one-week Baseline Phase, participants only completed surveys to establish baseline values. In the final two weeks of the study, participants self-administered treatment with the Empower device two times daily. Participants completed surveys over the two-week period to evaluate the effects of the Empower treatment.~Empower Neuromodulation System: Transcutaneous electrical nerve stimulation"
11357227|NCT03762681|OG000|Outcome|Part 1, Cohort 1: 0.1 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC.
11167125|NCT01977482|BG002|Baseline|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167126|NCT01977482|BG003|Baseline|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167127|NCT01977482|BG004|Baseline|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167128|NCT01977482|BG005|Baseline|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167129|NCT01977482|BG006|Baseline|Total|Total of all reporting groups
11167130|NCT01977482|FG000|Participant Flow|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167131|NCT01977482|FG001|Participant Flow|GSK1278863 4 mg|Participants received GSK1278863 4 milligrams (mg) once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167132|NCT01977482|FG002|Participant Flow|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167133|NCT01977482|FG003|Participant Flow|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167134|NCT01977482|FG004|Participant Flow|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167135|NCT01977482|FG005|Participant Flow|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167136|NCT01977482|OG000|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167137|NCT01977482|OG001|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167138|NCT01977482|OG002|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167139|NCT01977482|OG003|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167140|NCT01977482|OG004|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167141|NCT01977482|OG005|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167142|NCT01977482|OG000|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167143|NCT01977482|OG001|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167144|NCT01977482|OG002|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167145|NCT01977482|OG003|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167146|NCT01977482|OG004|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167147|NCT01977482|EG000|Reported Event|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167148|NCT01977482|EG001|Reported Event|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167149|NCT01977482|EG002|Reported Event|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167150|NCT01977482|EG003|Reported Event|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11351692|NCT03983317|OG000|Outcome|Active Treatment|"For the first week of the study, participants did not administer treatment with the Empower device. In this one-week Baseline Phase, participants only completed surveys to establish baseline values. In the final two weeks of the study, participants self-administered treatment with the Empower device two times daily. Participants completed surveys over the two-week period to evaluate the effects of the Empower treatment.~Empower Neuromodulation System: Transcutaneous electrical nerve stimulation"
11351693|NCT03983317|EG000|Reported Event|Active Treatment (AEs Occurred During the Two-week Treatment Phase)|"For the first week of the study, participants did not administer treatment with the Empower device. In this one-week Baseline Phase, participants only completed surveys to establish baseline values. In the final two weeks of the study, participants self-administered treatment with the Empower device two times daily. Participants completed surveys over the two-week period to evaluate the effects of the Empower treatment.~Empower Neuromodulation System: Transcutaneous electrical nerve stimulation"
11351694|NCT03985657|BG000|Baseline|All Participants|All participants enrolled in this study.
11351695|NCT03985657|FG000|Participant Flow|Baseline Sleep Study|Baseline sleep polysomnography involved the monitoring of electroencephalogram, electromyogram, electrocardiogram, airflow, heart rate, blood pressure, and pleural pressure during sleep with no CPAP. Participants in this arm would switch to CPAP within one week of the Baseline Sleep Study.
11351696|NCT03985657|FG001|Participant Flow|CPAP Sleep Study|In a randomized cross-over fashion, participants were treated with continuous positive airway pressure (CPAP) on a separate night. Room air at pressures between 6-9 centimeters of water (cmH2O) were delivered via heated humidified tubing and a nasal mask. Participants in this arm would switch to Baseline Sleep Study within one week of the CPAP Sleep Study.
11351697|NCT03985657|OG000|Outcome|Baseline Sleep Study|Baseline sleep polysomnography will involve the collection of electroencephalogram, electromyogram, electrocardiogram, airflow, heart rate, blood pressure, and pleural pressure during sleep with no CPAP.
11351698|NCT03985657|OG001|Outcome|CPAP Sleep Study|Participants will be treated with continuous positive airway pressure to relieve sleep-disordered breathing. CPAP: Continuous positive airway pressure (CPAP). Room air at pressures between 6-8 centimeters of water (cmH2O) delivered via heated humidified tubing and a nasal mask.
11351699|NCT03985657|EG000|Reported Event|Baseline Sleep Study|Baseline sleep polysomnography involved the monitoring of electroencephalogram, electromyogram, electrocardiogram, airflow, heart rate, blood pressure, and pleural pressure during sleep with no CPAP.
11351700|NCT03985657|EG001|Reported Event|CPAP Sleep Study|Participants were treated with continuous positive airway pressure (CPAP) on a separate night. Room air at pressures between 6-9 centimeters of water (cmH2O) were delivered via heated humidified tubing and a nasal mask.
11351701|NCT03981939|BG000|Baseline|CD Participants With CPAF - TOH|Participants diagnosed with CPAF from TOH were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11167151|NCT01977482|EG004|Reported Event|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11167152|NCT01977482|EG005|Reported Event|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
11351702|NCT03981939|BG001|Baseline|CD Participants Without CPAF (ICES Database)|Participants diagnosed with CD and without CPAF from ICES database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351703|NCT03981939|BG002|Baseline|CD Participants With CPAF (ICES Database)|Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351704|NCT03981939|BG003|Baseline|Total|Total of all reporting groups
11351705|NCT03981939|FG000|Participant Flow|CD Participants With CPAF - The Ottawa Hospital (TOH)|Participants diagnosed with CPAF from TOH were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351706|NCT03981939|FG001|Participant Flow|CD Participants Without CPAF (ICES Database)|Participants diagnosed with CD and without CPAF from ICES database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351707|NCT03981939|FG002|Participant Flow|CD Participants With CPAF (ICES Database)|Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351708|NCT03981939|OG000|Outcome|CD Participants With CPAF - TOH|Participants diagnosed with CPAF from TOH were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351709|NCT03981939|OG000|Outcome|CD Participants Without CPAF (ICES Database)|Participants diagnosed with CD and without CPAF from ICES database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351710|NCT03981939|OG001|Outcome|CD Participants With CPAF (ICES Database)|Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351711|NCT03981939|OG000|Outcome|No Intervention|Participants with CD and CPAF who did not receive any interventions following their first diagnosis of CPAF and were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351712|NCT03981939|OG001|Outcome|Exam Under Anesthesia (EUA) ± Seton Only|Participants with CD and CPAF received only EUA ± seton as part of their treatment, with no additional procedures administered in this group and were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11230364|NCT02405091|OG002|Outcome|Valbenazine 80/40mg|Participants received valbenazine 40mg once daily for 4 weeks, then 80mg. Participants who were unable to tolerate the 80mg dose had a dose decrease to 40mg capsule once daily for up to 44 weeks.
11230365|NCT02405091|OG002|Outcome|Valbenazine 80/40mg|Participants received valbenazine 40mg once daily for 4 weeks, then 80 mg. Participants who were unable to tolerate the 80 mg dose had a dose decrease to 40 mg capsule once daily for up to 44 weeks.
11230366|NCT02405091|OG001|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 4 weeks, then 80mg once daily for up to 44 weeks.
11230367|NCT02405091|EG000|Reported Event|Valbenazine 40 mg Through Week 4|Participants received valbenazine 40mg capsule once daily for 4 weeks.
11230368|NCT02405091|EG001|Reported Event|Valbenazine 40mg Week 4 Through Week 52|Participants received valbenazine 40mg capsule once daily for up to 44 weeks from Week 4 through Week 48.
11230369|NCT02405091|EG002|Reported Event|Valbenazine 80mg Week 4 Through Week 52|Participants received valbenazine 80mg once daily for up to 44 weeks from Week 4 through Week 48.
11230370|NCT02405091|EG003|Reported Event|Valbenazine 80/40mg Week 4 Through Week 52|Participants who were unable to tolerate the 80mg dose had a dose decrease to 40mg capsule once daily for up to 44 weeks from Week 4 through Week 48.
11230371|NCT02405195|BG000|Baseline|CardioPulmonary Bypass|Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
11230372|NCT02405195|FG000|Participant Flow|CardioPulmonaryBypass|Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
11230373|NCT02405195|OG000|Outcome|CardioPulmonaryBypass|Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
11230374|NCT02405195|EG000|Reported Event|CardioPulmonaryBypass|Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
11230375|NCT02405325|BG000|Baseline|Physical Activity|"The program will be run by peer Leaders and senior center staff with the support of UCSD staff. Participants will work towards a 2000 increase in daily steps through self-paced incidental walking and peer led group walks.~Physical Activity: intervention activities will remain at the daily level, including using pedometers, having daily goals, attendance at Peer lead group walks and recognition of efforts through monthly celebrations and bi-weekly goal tracking with peer Health Coaches."
11230376|NCT02405325|BG001|Baseline|Usual Care|Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
11230377|NCT02405325|BG002|Baseline|Total|Total of all reporting groups
11230378|NCT02405325|FG000|Participant Flow|Physical Activity|"The program will be run by peer Leaders and senior center staff with the support of UCSD staff. Participants will work towards a 2000 increase in daily steps through self-paced incidental walking and peer led group walks.~Physical Activity: intervention activities will remain at the daily level, including using pedometers, having daily goals, attendance at Peer lead group walks and recognition of efforts through monthly celebrations and bi-weekly goal tracking with peer Health Coaches."
11230379|NCT02405325|FG001|Participant Flow|Usual Care|Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
11230380|NCT02405325|OG000|Outcome|Physical Activity|"The program will be run by peer Leaders and senior center staff with the support of UCSD staff. Participants will work towards a 2000 increase in daily steps through self-paced incidental walking and peer led group walks.~Physical Activity: intervention activities will remain at the daily level, including using pedometers, having daily goals, attendance at Peer lead group walks and recognition of efforts through monthly celebrations and bi-weekly goal tracking with peer Health Coaches."
11230381|NCT02405325|OG001|Outcome|Usual Care|Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
11230382|NCT02405325|EG000|Reported Event|Physical Activity|"The program will be run by peer Leaders and senior center staff with the support of UCSD staff. Participants will work towards a 2000 increase in daily steps through self-paced incidental walking and peer led group walks.~Physical Activity: intervention activities will remain at the daily level, including using pedometers, having daily goals, attendance at Peer lead group walks and recognition of efforts through monthly celebrations and bi-weekly goal tracking with peer Health Coaches."
11230383|NCT02405325|EG001|Reported Event|Usual Care|Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
11230384|NCT02405390|BG000|Baseline|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
11230385|NCT02405390|BG001|Baseline|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
11230386|NCT02405390|BG002|Baseline|Total|Total of all reporting groups
11230387|NCT02405390|FG000|Participant Flow|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
11230388|NCT02405390|FG001|Participant Flow|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
11230389|NCT02405390|OG000|Outcome|Video Laryngoscopy|Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
11230390|NCT02405390|OG001|Outcome|Direct Laryngoscopy|Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
11230391|NCT02405390|EG000|Reported Event|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
11351713|NCT03981939|OG002|Outcome|Advanced Intervention|Participants with CD and CPAF received 2 x EUA ± seton and single EUA ± seton, followed by an advanced intervention or diversion procedure. The participants who did not receive EUA ± seton received advanced intervention or diversion as their 1st line of treatment in this group and were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351714|NCT03981939|EG000|Reported Event|CD Participants With CPAF - The Ottawa Hospital (TOH)|Participants diagnosed with CPAF from TOH were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351715|NCT03981939|EG001|Reported Event|CD Participants Without CPAF (ICES Database)|Participants diagnosed with CD and without CPAF from ICES database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351716|NCT03981939|EG002|Reported Event|CD Participants With CPAF (ICES Database)|Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
11351717|NCT03973905|BG000|Baseline|Pertussis Case Group|Infant subjects of at least 2 days old and less than (<) 2 months old, who met the pertussis diagnosis definition (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case, clinically compatible illness), and who met the case infants inclusion criteria (resided in the catchment area on their cough onset date, were born in a hospital in their state of residence, had at least 37 weeks gestational age at birth, were neither adopted, nor in foster care and did not live in a residential care facility) This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
11351718|NCT03973905|BG001|Baseline|Control Group|Infant subjects of at least 2 days old and less than (<) 2 months old, who did not have a pertussis diagnosis prior to the cough onset date and who met the inclusion criteria for control infants (were born on a hospital in their state of residence, were at least 37 weeks gestational age at birth, were neither adopted, nor in foster care, did not live in a residential care facility, were born at the same hospital as the case infant) This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
11351719|NCT03973905|BG002|Baseline|Total|Total of all reporting groups
11167153|NCT01977547|BG000|Baseline|Short Storage|"Red blood cells storage duration of equal to or less than 7 days.~Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit"
11167154|NCT01977547|BG001|Baseline|Standard Issue|"Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.~Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit"
11167155|NCT01977547|BG002|Baseline|Total|Total of all reporting groups
11351720|NCT03973905|FG000|Participant Flow|Pertussis Case Group|Infant subjects of at least 2 days old and less than (<) 2 months old, who met the pertussis diagnosis definition (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case, clinically compatible illness), and who met the case infants inclusion criteria (resided in the catchment area on their cough onset date, were born in a hospital in their state of residence, had at least 37 weeks gestational age at birth, were neither adopted, nor in foster care and did not live in a residential care facility) This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
11357228|NCT03762681|OG001|Outcome|Part 1, Cohort 2: 0.3 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC.
11357229|NCT03762681|OG002|Outcome|Part 1, Cohort 3: 1.0 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC.
11357230|NCT03762681|OG003|Outcome|Part 1, Cohort 4: 1.5 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC.
11167156|NCT01977547|FG000|Participant Flow|Short Storage|"Red blood cells storage duration of equal to or less than 7 days.~Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit"
11167157|NCT01977547|FG001|Participant Flow|Standard Issue|"Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.~Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit"
11167158|NCT01977547|OG000|Outcome|Short Storage|"Red blood cells storage duration of equal to or less than 7 days.~Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit"
11167159|NCT01977547|OG001|Outcome|Standard Issue|"Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.~Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit"
11167160|NCT01977547|EG000|Reported Event|Short Storage|"Red blood cells storage duration of equal to or less than 7 days.~Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit"
11167161|NCT01977547|EG001|Reported Event|Standard Issue|"Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.~Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit"
11167162|NCT01977573|BG000|Baseline|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
11351721|NCT03973905|FG001|Participant Flow|Control Group|Infant subjects of at least 2 days old and less than (<) 2 months old, who did not have a pertussis diagnosis prior to the cough onset date and who met the inclusion criteria for control infants (were born on a hospital in their state of residence, were at least 37 weeks gestational age at birth, were neither adopted, nor in foster care, did not live in a residential care facility, were born at the same hospital as the case infant) This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
11351722|NCT03973905|OG000|Outcome|Pertussis Case Group|Infant subjects of at least 2 days old and less than (<) 2 months old, who met the pertussis diagnosis definition (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case, clinically compatible illness), and who met the case infants inclusion criteria (resided in the catchment area on their cough onset date, were born in a hospital in their state of residence, had at least 37 weeks gestational age at birth, were neither adopted, nor in foster care and did not live in a residential care facility) This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
11351723|NCT03973905|OG001|Outcome|Control Group|Infant subjects of at least 2 days old and less than (<) 2 months old, who did not have a pertussis diagnosis prior to the cough onset date and who met the inclusion criteria for control infants (were born on a hospital in their state of residence, were at least 37 weeks gestational age at birth, were neither adopted, nor in foster care, did not live in a residential care facility, were born at the same hospital as the case infant) This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
11351724|NCT03973905|EG000|Reported Event|Pertussis Case Group|Infant subjects of at least 2 days old and less than (<) 2 months old, who met the pertussis diagnosis definition (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case, clinically compatible illness), and who met the case infants inclusion criteria (resided in the catchment area on their cough onset date, were born in a hospital in their state of residence, had at least 37 weeks gestational age at birth, were neither adopted, nor in foster care and did not live in a residential care facility) This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
11351725|NCT03973905|EG001|Reported Event|Control Group|Infant subjects of at least 2 days old and less than (<) 2 months old, who did not have a pertussis diagnosis prior to the cough onset date and who met the inclusion criteria for control infants (were born on a hospital in their state of residence, were at least 37 weeks gestational age at birth, were neither adopted, nor in foster care, did not live in a residential care facility, were born at the same hospital as the case infant) This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
11351726|NCT03984838|BG000|Baseline|DTG/RPV 50mg/25mg FDC|Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
11351727|NCT03984838|FG000|Participant Flow|DTG/RPV 50mg/25mg FDC|Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
11351728|NCT03984838|OG000|Outcome|DTG/RPV 50mg/25mg FDC|Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
11351729|NCT03984838|EG000|Reported Event|DTG/RPV 50mg/25mg FDC|Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
11351730|NCT03983941|BG000|Baseline|FNB-AC + Sciatic Nerve Block|"Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.~Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine."
11351731|NCT03983941|BG001|Baseline|FNB-AC + IPACK|"Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)~Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine."
11351732|NCT03983941|BG002|Baseline|Total|Total of all reporting groups
11351733|NCT03983941|FG000|Participant Flow|FNB-AC + Sciatic Nerve Block|"Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.~Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine."
11351734|NCT03983941|FG001|Participant Flow|FNB-AC + IPACK|"Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)~Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine."
11351735|NCT03983941|OG000|Outcome|FNB-AC + Sciatic Nerve Block|"Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.~Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine."
11351736|NCT03983941|OG001|Outcome|FNB-AC + IPACK|"Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)~Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine."
11357231|NCT03762681|OG004|Outcome|Part 2a, Arm 1: 0.2 mg/kg RO7239958|Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11351737|NCT03983941|EG000|Reported Event|FNB-AC + Sciatic Nerve Block|"Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.~Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine."
11351738|NCT03983941|EG001|Reported Event|FNB-AC + IPACK|"Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)~Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine."
11351739|NCT03976752|BG000|Baseline|Pre-drug|Participants enrolled in the pre-drug arm did not receive any drug. At visit 2, they underwent blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection.
11351740|NCT03976752|BG001|Baseline|Genvoya|"Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.~Participants took Genvoya and had specimens collected at different time points. Arm A: specimen collection occurred 2 hours and after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5) Arm B: specimen collection occurred 4 hours and after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5) Arm C: specimen collection occurred 24 hours and after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5) Arm D: specimen collection occurred 8 hours after taking the medication in the clinic (visit 4), for a single time point of specimen collection"
11351741|NCT03976752|BG002|Baseline|Total|Total of all reporting groups
11351742|NCT03976752|FG000|Participant Flow|Pre-drug|Participants enrolled in the pre-drug arm will not receive any drug. At visit 2, they will undergo blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection.
11351743|NCT03976752|FG001|Participant Flow|Genvoya|"Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.~Participants took Genvoya and had specimens collected at different time points.~Arm A: specimen collection occurred 2 hours and after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5)~Arm B: specimen collection occurred 4 hours and after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5)~Arm C: specimen collection occurred 24 hours and after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5)~Arm D: specimen collection occurred 8 hours after taking the medication in the clinic (visit 4), for a single time point of specimen collection"
11351744|NCT03976752|OG000|Outcome|Genvoya - 2 and 48 Hours Specimen Collection|Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
11351745|NCT03976752|OG001|Outcome|Genvoya - 4 and 72 Hours Specimen Collection|Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
11351746|NCT03976752|OG002|Outcome|Genvoya - 24 and 96 Hours Specimen Collection|Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
11351747|NCT03976752|OG003|Outcome|Genvoya - Single Time Point Specimen Collection|Specimen collection 8 hours after taking the medication in the clinic (visit 4).
11351748|NCT03976752|EG000|Reported Event|Pre-drug|Participants enrolled in the pre-drug arm will not receive any drug. At visit 2, they will undergo blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection.
11351749|NCT03976752|EG001|Reported Event|Genvoya - 2 and 48 Hours Specimen Collection|"Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).~Genvoya: Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat.~At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic."
11357232|NCT03762681|OG005|Outcome|Part 2a, Arm 2: 0.4 mg/kg RO7239958|Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11167163|NCT01977573|BG001|Baseline|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator's clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
11167164|NCT01977573|BG002|Baseline|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator's opinion] to start rhEPO therapy).
11357233|NCT03762681|OG000|Outcome|Part 2a: Placebo|Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W).
11357234|NCT03762681|OG001|Outcome|Part 2a, Arm 1: 0.2 mg/kg RO7239958|Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11167165|NCT01977573|BG003|Baseline|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
11351750|NCT03976752|EG002|Reported Event|Genvoya - 4 and 72 Hours Specimen Collection|"Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).~Genvoya: Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat.~At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic."
11351751|NCT03976752|EG003|Reported Event|Genvoya - 24 and 96 Hours Specimen Collection|"Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).~Genvoya: Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat.~At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic."
11351752|NCT03976752|EG004|Reported Event|Genvoya - Single Time Point Specimen Collection|"Specimen collection 8 hours after taking the medication in the clinic (visit 4).~Genvoya: Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat.~At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic."
11357235|NCT03762681|OG002|Outcome|Part 2a, Arm 2: 0.4 mg/kg RO7239958|Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11357236|NCT03762681|EG000|Reported Event|Part 1, Cohorts 1-4: Placebo|Healthy volunteers were administered a single dose of placebo subcutaneously (SC).
11357237|NCT03762681|EG001|Reported Event|Part 1, Cohort 1: 0.1 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC.
11357238|NCT03762681|EG002|Reported Event|Part 1, Cohort 2: 0.3 mg/kg RO7239958|Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC.
11357239|NCT03762681|EG003|Reported Event|Part 1, Cohort 3: 1.0 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC.
11357240|NCT03762681|EG004|Reported Event|Part 1, Cohort 4: 1.5 mg/kg RO7239958|Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC.
11357241|NCT03762681|EG005|Reported Event|Part 2a: Placebo|Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W).
11357242|NCT03762681|EG006|Reported Event|Part 2a, Arm 1: 0.2 mg/kg RO7239958|Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11357243|NCT03762681|EG007|Reported Event|Part 2a, Arm 2: 0.4 mg/kg RO7239958|Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W.
11357244|NCT03762668|BG000|Baseline|MDACL, Then DACL|MDACL worn first, followed by DACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
11357245|NCT03762668|BG001|Baseline|DACL, Then MDACL|DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
11357246|NCT03762668|BG002|Baseline|Total|Total of all reporting groups
11357247|NCT03762668|FG000|Participant Flow|MDACL, Then DACL|Modified delefilcon A contact lenses (MADCL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
11357248|NCT03762668|FG001|Participant Flow|DACL, Then MDACL|DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
11167166|NCT01977573|BG004|Baseline|Total|Total of all reporting groups
11357249|NCT03762668|OG000|Outcome|MDACL|MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized
11357250|NCT03762668|OG001|Outcome|DACL|DACL worn for approximately 1 week, Period 1 or Period 2, as randomized
11357251|NCT03762668|EG000|Reported Event|MDACL|MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized
11357252|NCT03762668|EG001|Reported Event|DACL|DACL worn for approximately 1 week, Period 1 or Period 2, as randomized
11357253|NCT03762616|BG000|Baseline|Micro-ultrasound Biopsy Then MRI Biopsy|Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by... mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
11357254|NCT03762616|FG000|Participant Flow|Micro-ultrasound Biopsy Then MRI Biopsy|Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by MRI biopsy by a second blinded operator
11357255|NCT03762616|OG000|Outcome|Micro-ultrasound Biopsy|Micro-ultrasound biopsy: Micro-ultrasound biopsy using the ExactVu micro-ultrasound system
11357256|NCT03762616|OG001|Outcome|MRI Targeted Biopsy|mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
11357257|NCT03762616|EG000|Reported Event|Micro-ultrasound Targeted Biopsy|Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system
11357258|NCT03762616|EG001|Reported Event|MRI Targeted Biopsy|mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
11351753|NCT03984825|BG000|Baseline|Portia Followed by Portia + GSK3640254|Participants in Run-in period received Portia (0.03 milligram [mg] EE/0.15 mg LNG) once daily (QD) on Day -3 through Day -1. Participants in Treatment Period 1 received Portia (0.3 mg EE/ 0.15 mg LNG) QD on Day 1 through Day 10. In Treatment Period 2 participants received Portia QD co-administered with GSK3640254 200 mg QD on Day 11 through Day 21. There was no washout period between two periods.
11351754|NCT03984825|FG000|Participant Flow|Portia Followed by Portia + GSK3640254|Participants in Run-in period received Portia (0.03 milligram [mg] EE/0.15 mg LNG) once daily (QD) on Day -3 through Day -1. Participants in Treatment Period 1 received Portia (0.3 mg EE/ 0.15 mg LNG) QD on Day 1 through Day 10. In Treatment Period 2 participants received Portia QD co-administered with GSK3640254 200 mg QD on Day 11 through Day 21. There was no washout period between two periods.
11351755|NCT03984825|OG000|Outcome|Portia (0.3 mg EE/ 0.15 mg LNG)|Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.
11351756|NCT03984825|OG000|Outcome|Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254|Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
11351757|NCT03984825|OG001|Outcome|Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254|Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
11351758|NCT03984825|OG000|Outcome|Portia - Run-in Period (Day -3 to Day -1)|Participants in Run-in period received Portia (0.03 mg EE/0.15 mg LNG) QD on Day -3 through Day -1.
11351759|NCT03984825|EG000|Reported Event|Portia - Run-in Period (Day -3 to Day -1)|Participants in Run-in period received Portia (0.03 mg EE/0.15 mg LNG) QD on Day -3 through Day -1.
11351760|NCT03984825|EG001|Reported Event|Portia (0.3 mg EE/ 0.15 mg LNG)|Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.
11351761|NCT03984825|EG002|Reported Event|Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254|Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
11351762|NCT03971721|BG000|Baseline|Wave Mattress Support|"The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.~Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned."
11351763|NCT03971721|FG000|Participant Flow|Wave Mattress Support|"The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.~Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles and that the system is working as planned."
11351764|NCT03971721|OG000|Outcome|Wave Mattress Support|"The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.~Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned."
11351765|NCT03971721|EG000|Reported Event|Wave Mattress Support|"The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.~Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned."
11351766|NCT03982433|BG000|Baseline|Intervention|"participants all receive the intervention~Motivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference"
11351767|NCT03982433|FG000|Participant Flow|Intervention|"8 participants assigned to receive the intervention~Motivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference"
11351768|NCT03982433|OG000|Outcome|Intervention|"8 participants all receive the intervention~Motivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference"
11351769|NCT03982433|EG000|Reported Event|Intervention|"8 participants all receive the intervention~Motivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference"
11351770|NCT03979677|BG000|Baseline|Single Lifestyle Modification Intervention Group|Participants were recruited from patients seen for consultation for dizziness and/or imbalance in the John S. Odess Otolaryngology and Head and Neck Surgery Clinic. Consultations were provided by two nurse practitioners and one otolaryngologist. All clinicians were experienced in diagnosis and management of dizziness and imbalance including VM. All adult patients diagnosed with definite VM using the consensus criteria4 were eligible for inclusion. Patients who were determined to need pharmacological management at initial consultation were excluded.
11351771|NCT03979677|FG000|Participant Flow|Single Lifestyle Modification Intervention Group|Participants were recruited from patients seen for consultation for dizziness and/or imbalance in the John S. Odess Otolaryngology and Head and Neck Surgery Clinic. Consultations were provided by two nurse practitioners and one otolaryngologist. All clinicians were experienced in diagnosis and management of dizziness and imbalance including VM. All adult patients diagnosed with definite VM using the consensus criteria4 were eligible for inclusion. Patients who were determined to need pharmacological management at initial consultation were excluded.
11351772|NCT03979677|OG000|Outcome|Intervention Group|"All participants will be provided written and verbal instructions regarding the lifestyle modification intervention.~Lifestyle Modifications: Written suggestions on common migraine triggering food/beverages to avoid, restful sleep tips, exercise suggestions, and eating set mealtimes will be provided as the intervention."
11351773|NCT03979677|EG000|Reported Event|Single Lifestyle Modification Intervention Group|Participants were recruited from patients seen for consultation for dizziness and/or imbalance in the John S. Odess Otolaryngology and Head and Neck Surgery Clinic. Consultations were provided by two nurse practitioners and one otolaryngologist. All clinicians were experienced in diagnosis and management of dizziness and imbalance including VM. All adult patients diagnosed with definite VM using the consensus criteria4 were eligible for inclusion. Patients who were determined to need pharmacological management at initial consultation were excluded.
11351774|NCT03976466|BG000|Baseline|Calcium Sulfate Group|"Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement~Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection"
11351775|NCT03976466|BG001|Baseline|Control Group|"Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement~Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection"
11351776|NCT03976466|BG002|Baseline|Total|Total of all reporting groups
11351777|NCT03976466|FG000|Participant Flow|Calcium Sulfate Study Group|"Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement~Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 3g of vancomycin mixed with Stimulan Kit (Biocomposites Ltd, United Kingdom) which includes 10 cc (20 g) of calcium sulfate hemihydrate powder"
11351778|NCT03976466|FG001|Participant Flow|Control Group|"Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement~Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 750 mgs of Intra Venous Ceftriaxone 20 minutes before joint replacement surgery and every 8 hours for 24 hours"
11351779|NCT03976466|OG000|Outcome|Control Group|"Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement~Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection"
11351780|NCT03976466|OG001|Outcome|Calcium Sulfate Group|"Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement~Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection"
11351781|NCT03976466|OG000|Outcome|Control Group|"Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement~Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 750 mgs of Intra Venous Ceftriaxone 20 minutes before joint replacement surgery and every 8 hours for 24 hours"
11351782|NCT03976466|OG001|Outcome|Calcium Sulfate Study Group|"Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement~Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 3g of vancomycin mixed with Stimulan Kit (Biocomposites Ltd, United Kingdom) which includes 10 cc (20 g) of calcium sulfate hemihydrate powder"
11351783|NCT03976466|EG000|Reported Event|Calcium Sulfate Study Group|"Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement~Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 3g of vancomycin mixed with Stimulan Kit (Biocomposites Ltd, United Kingdom) which includes 10 cc (20 g) of calcium sulfate hemihydrate powder"
11351784|NCT03976466|EG001|Reported Event|Control Group|"Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement~Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 750 mgs of Intra Venous Ceftriaxone 20 minutes before joint replacement surgery and every 8 hours for 24 hours"
11167167|NCT01977573|FG000|Participant Flow|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
11230392|NCT02405390|EG001|Reported Event|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
11230393|NCT02405429|BG000|Baseline|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
11230394|NCT02405429|FG000|Participant Flow|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
11230395|NCT02405429|OG000|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
11230396|NCT02405429|EG000|Reported Event|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
11230397|NCT02405442|BG000|Baseline|Andecaliximab 150 mg Every 2 Weeks|"Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230398|NCT02405442|BG001|Baseline|Andecaliximab 150 mg Weekly|"Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230399|NCT02405442|BG002|Baseline|Andecaliximab 300 mg Weekly|"Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230400|NCT02405442|BG003|Baseline|Placebo|"Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.~Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230401|NCT02405442|BG004|Baseline|Total|Total of all reporting groups
11230402|NCT02405442|FG000|Participant Flow|Andecaliximab 150 mg Every 2 Weeks|"Double-Blind Phase: Participants received 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230403|NCT02405442|FG001|Participant Flow|Andecaliximab 150 mg Weekly|"Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230404|NCT02405442|FG002|Participant Flow|Andecaliximab 300 mg Weekly|"Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230405|NCT02405442|FG003|Participant Flow|Placebo|"Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.~Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230406|NCT02405442|OG000|Outcome|Andecaliximab 150 mg Every 2 Weeks|"Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230407|NCT02405442|OG001|Outcome|Andecaliximab 150 mg Weekly|"Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230408|NCT02405442|OG002|Outcome|Andecaliximab 300 mg Weekly|"Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.~Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230409|NCT02405442|OG003|Outcome|Placebo|"Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.~Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly."
11230410|NCT02405442|EG000|Reported Event|Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W)|Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 1 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
11230411|NCT02405442|EG001|Reported Event|Double-Blind Andecaliximab 150 mg Weekly (QW)|Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
11230412|NCT02405442|EG002|Reported Event|Double-Blind Andecaliximab 300 mg Weekly|Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
11230413|NCT02405442|EG003|Reported Event|Double-Blind Placebo|Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
11230414|NCT02405442|EG004|Reported Event|Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W|Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Every 2 Weeks group.
11230415|NCT02405442|EG005|Reported Event|Open-Label Andecaliximab QW From Andecaliximab 150 mg QW|Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Weekly group.
11351785|NCT03979638|BG000|Baseline|BLU-5937 > Placebo|"Randomized crossover design of 4 different doses (25, 50, 100, 200 mg BID) of BLU-5937 tablets to be administered orally BID~BLU-5937: Four escalating doses of BLU-5937 administered BID over the course of the study followed by matching Placebo"
11351786|NCT03979638|BG001|Baseline|Placebo > BLU-5937|"Randomized crossover design of matching placebo tablets to be administered orally BID~Placebo: Matching placebo for BLU-5937 followed by four escalating doses of BLU-5937"
11351787|NCT03979638|BG002|Baseline|Total|Total of all reporting groups
11351788|NCT03979638|FG000|Participant Flow|BLU-5937 > Placebo|"Randomized crossover design of 4 different doses (25, 50, 100, 200 mg BID) of BLU-5937 tablets to be administered orally BID~BLU-5937: Four escalating doses of BLU-5937 administered BID over the course of the study followed by matching Placebo"
11351789|NCT03979638|FG001|Participant Flow|Placebo > BLU-5937|"Randomized crossover design of matching placebo tablets to be administered orally BID~Placebo: Matching placebo for BLU-5937 follow by four escalating doses of BLU-5937"
11351790|NCT03979638|OG000|Outcome|BLU-5937 - 25 mg|BLU-5937 25 mg tablet administered orally BID for 4 days
11351791|NCT03979638|OG001|Outcome|Placebo Comparator - 25 mg|Matching Placebo for BLU-5937 administered orally BID for 4 days
11351792|NCT03979638|OG002|Outcome|BLU-5937 - 50 mg|BLU-5937 50 mg tablet administered orally BID for 4 days
11351793|NCT03979638|OG003|Outcome|Placebo Comparator - 50 mg|Matching Placebo for BLU-5937 administered orally BID for 4 days
11351794|NCT03979638|OG004|Outcome|BLU-5937 - 100 mg|BLU-5937 100 mg tablet administered orally BID for 4 days
11351795|NCT03979638|OG005|Outcome|Placebo Comparator - 100 mg|Matching Placebo for BLU-5937 administered orally BID for 4 days
11351796|NCT03979638|OG006|Outcome|BLU-5937 - 200 mg|BLU-5937 200 mg tablet administered orally BID for 4 days
11351797|NCT03979638|OG007|Outcome|Placebo Comparator - 200 mg|Matching Placebo for BLU-5937 administered orally BID for 4 days
11351798|NCT03979638|EG000|Reported Event|BLU-5937 - 25 mg|BLU-5937 25 mg tablet administered orally BID for 4 days
11351799|NCT03979638|EG001|Reported Event|BLU-5937 - 50 mg|BLU-5937 50 mg tablet administered orally BID for 4 days
11351800|NCT03979638|EG002|Reported Event|BLU-5937 - 100 mg|BLU-5937 100 mg tablet administered orally BID for 4 days
11089399|NCT01523704|EG001|Reported Event|Control|"Patients assigned to Control Group (HM + Conventional In-office follow-up - Control group) will have HM programmed ON. In addition to HM, these patients will visit the hospital for device interrogation at 3, 9, 15, 21 and 27 month follow-ups.~BIOTRONIK Home Monitoring System with In-office Follow-up"
11351801|NCT03979638|EG003|Reported Event|BLU-5937 - 200 mg|BLU-5937 200 mg tablet administered orally BID for 4 days
11351802|NCT03979638|EG004|Reported Event|Placebo|Matching Placebo for BLU-5937 administered orally BID for 4 days
11089400|NCT01523743|BG000|Baseline|All Study Participants|"125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data.~The baseline and analysis data are based on the ITT population."
11089401|NCT01523743|FG000|Participant Flow|First Compact Catheter, Then Standard Care|First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject
11351803|NCT03979274|BG000|Baseline|All Participants|All participants who received a single oral dose of Reference Eutirox® 600 mcg (200*3 mcg) or a single oral dose of test Eutirox® 600 mcg (200*3 mcg) in either Treatment Period 1 or 2.
11351804|NCT03979274|FG000|Participant Flow|Reference Eutirox®, Then Test Eutirox®|Participants received single oral dose of Reference Eutirox® 600 microgram (mcg) (3 tablets of 200 mcg) in Treatment Period 1 followed by single oral dosing of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 2. A wash-out period of 35 days was maintained between the Treatment Periods 1 and 2.
11351805|NCT03979274|FG001|Participant Flow|Test Eutirox®, Then Reference Eutirox®|Participants received single oral dose of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 1 followed by single oral dosing of Reference Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 2. A wash-out period of 35 days was maintained between the Treatment Periods 1 and 2.
11351806|NCT03979274|OG000|Outcome|Refernece Eutirox®|Participants received single oral dose of Reference Eutirox® 600 mcg (3 tablets of 200 mcg) in either Treatment Period 1 or 2 under fasting conditions.
11351807|NCT03979274|OG001|Outcome|Test Eutirox®|Participants received single oral dose of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in either Treatment Period 1 or 2 under fasting conditions.
11351808|NCT03979274|EG000|Reported Event|Reference Eutirox®|Participants received single oral dose of Reference Eutirox® 600 mcg (3 tablets of 200 mcg) in either Treatment Period 1 or 2 under fasting conditions.
11351809|NCT03979274|EG001|Reported Event|Test Eutirox®|Participants received single oral dose of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in either Treatment Period 1 or 2 under fasting conditions.
11351810|NCT03979066|BG000|Baseline|Atezolizumab|"Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.~Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery."
11351811|NCT03979066|BG001|Baseline|Atezolizumab in Combination With PEGPH20|"Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.~Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.~PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery."
11351812|NCT03979066|BG002|Baseline|Total|Total of all reporting groups
11351813|NCT03979066|FG000|Participant Flow|Atezolizumab|"Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.~Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery."
11351814|NCT03979066|FG001|Participant Flow|Atezolizumab in Combination With PEGPH20|"Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.~Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.~PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery."
11351815|NCT03979066|OG000|Outcome|Atezolizumab|"Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.~Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery."
11351816|NCT03979066|OG001|Outcome|Atezolizumab in Combination With PEGPH20|"Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.~Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.~PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery."
11351817|NCT03979066|EG000|Reported Event|Atezolizumab|"Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.~Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery."
11351818|NCT03979066|EG001|Reported Event|Atezolizumab in Combination With PEGPH20|"Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.~Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.~PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery."
11351819|NCT03977727|BG000|Baseline|Fiasp/Novolog|"7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion~Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII"
11351820|NCT03977727|BG001|Baseline|Novolog/Fiasp|"7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion~Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII"
11351821|NCT03977727|BG002|Baseline|Total|Total of all reporting groups
11351822|NCT03977727|FG000|Participant Flow|Fiasp/Novolog|"7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion~Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII"
11351823|NCT03977727|FG001|Participant Flow|Novolog/Fiasp|"7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion~Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII"
11351824|NCT03977727|OG000|Outcome|Fiasp/Novolog|Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®
11351825|NCT03977727|OG001|Outcome|Novolog/Fiasp|Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
11351826|NCT03977727|EG000|Reported Event|Fiasp/Novolog|"7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion~Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII"
11351827|NCT03977727|EG001|Reported Event|Novolog/Fiasp|"7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion~Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system~670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII"
11351828|NCT03977155|BG000|Baseline|High Dose of BOS-589|Randomized participants received a high dose of BOS-589 tablets orally BID.
11351829|NCT03977155|BG001|Baseline|Low Dose of BOS-589|Randomized participants received a low dose of BOS-589 tablets orally BID.
11089402|NCT01523743|FG001|Participant Flow|First Standard Care; Then Compact Catheter|First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast
11089403|NCT01523743|OG000|Outcome|Compact Catheter|Compact intermittent catheter
11351830|NCT03977155|BG002|Baseline|Placebo|Randomized participants received matching placebo tablets orally BID.
11351831|NCT03977155|BG003|Baseline|Total|Total of all reporting groups
11351832|NCT03977155|FG000|Participant Flow|High Dose of BOS-589|Randomized participants received a high dose of BOS-589 tablets orally twice a day (BID).
11351833|NCT03977155|FG001|Participant Flow|Low Dose of BOS-589|Randomized participants received a low dose of BOS-589 tablets orally BID.
11351834|NCT03977155|FG002|Participant Flow|Placebo|Randomized participants received matching placebo tablets orally BID.
11089404|NCT01523743|OG001|Outcome|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
11089405|NCT01523743|EG000|Reported Event|Compact Catheter|Compact intermittent catheter
11089406|NCT01523743|EG001|Reported Event|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
11089407|NCT01523756|BG000|Baseline|Overall Study|
11351835|NCT03977155|OG000|Outcome|High Dose of BOS-589|Randomized participants received a high dose of BOS-589 tablets orally BID.
11351836|NCT03977155|OG001|Outcome|Low Dose of BOS-589|Randomized participants received a low dose of BOS-589 tablets orally BID.
11351837|NCT03977155|OG002|Outcome|BOS-589: Active Treatment|"High Dose of BOS-589: Randomized participants received a high dose of BOS-589 tablets orally BID.~Low Dose of BOS-589: Randomized participants received a low dose of BOS-589 tablets orally BID.~Data were pooled from the above mentioned doses for analysis."
11351838|NCT03977155|OG003|Outcome|Placebo|Randomized participants received matching placebo tablets orally BID.
11351839|NCT03977155|OG002|Outcome|Placebo|Randomized participants received matching placebo tablets orally BID.
11351840|NCT03977155|EG000|Reported Event|High Dose of BOS-589|Randomized participants received a high dose of BOS-589 tablets orally BID.
11351841|NCT03977155|EG001|Reported Event|Low Dose of BOS-589|Randomized participants received a low dose of BOS-589 tablets orally BID.
11351842|NCT03977155|EG002|Reported Event|Placebo|Randomized participants received matching placebo tablets orally BID.
11351843|NCT03974802|BG000|Baseline|Overall Study|"Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks.~somofilcon A contact lens: Contact Lens~fanfilcon A contact lens: Contact Lens"
11351844|NCT03974802|FG000|Participant Flow|Somofilcon A (Habitual) Lens, Then Fanfilcon A (Test) Lens|"Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks.~somofilcon A contact lens: Contact Lens~fanfilcon A contact lens: Contact Lens"
11351845|NCT03974802|OG000|Outcome|Somofilcon A (Habitual) Lens|"Participants wore their habitual somofilcon A lens for 4-weeks.~somofilcon A: Contact lens"
11351846|NCT03974802|OG000|Outcome|Fanfilcon A (Test) Lens|"Participants were refitted with fanfilcon A test lens for 4-weeks.~fanfilcon A: Contact lens"
11351847|NCT03974802|OG000|Outcome|Fanfilcon A (Test) Lens|"Participants were refitted with fanfilcon A lens (test) for 4-weeks.~fanfilcon A: Contact lens"
11351848|NCT03974802|OG000|Outcome|Fanfilcon A Lens (Test)|"Participants were refitted with fanfilcon A lens (test) for 4-weeks.~fanfilcon A: Contact lens"
11351849|NCT03974802|OG000|Outcome|Fanfilcon A Lens (Test)|"Participants were refitted with Participants were refitted with fanfilcon A lens (test) for 4-weeks.~fanfilcon A: Contact lens"
11351850|NCT03974802|EG000|Reported Event|Somofilcon A (Habitual) Lens|"Subjects wore their habitual somofilcon A lens for 4 -weeks.~somofilcon A contact lens: Contact Lens"
11351851|NCT03974802|EG001|Reported Event|Fanfilcon A (Test) Lens|"Subjects were refitted with fanfilcon A lens (test) for 4- weeks.~fanfilcon A contact lens: Contact Lens"
11167168|NCT01977573|FG001|Participant Flow|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator's clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
11351852|NCT03970733|BG000|Baseline|VLA15 With Alum Lower Dose|"0.75 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180.~VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate"
11351853|NCT03970733|BG001|Baseline|VLA15 With Alum Higher Dose|1 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
11351854|NCT03970733|BG002|Baseline|Placebo|1 ml injection of placebo applied at Days 1, 57, and 180. Placebo: phosphate buffered saline (PBS) solution
11351855|NCT03970733|BG003|Baseline|Total|Total of all reporting groups
11351856|NCT03970733|FG000|Participant Flow|VLA15 With Alum Lower Dose|"Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm disconitinued~VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate"
11351857|NCT03970733|FG001|Participant Flow|VLA15 With Alum Higher Dose|"Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo~VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate"
11351858|NCT03970733|FG002|Participant Flow|Placebo|"Main Study Phase: placebo - Booster phase: arm discontinued~Placebo: PBS (Phosphate Buffered Saline)"
11351859|NCT03970733|OG000|Outcome|VLA15 With Alum Lower Dose|"Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued~VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate"
11351860|NCT03970733|OG001|Outcome|VLA15 With Alum Higher Dose|"Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo~VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate"
11351861|NCT03970733|OG002|Outcome|Placebo|"Main Study Phase: placebo - Booster Phase: arm discontinued~Placebo: PBS (Phosphate Buffered Saline)"
11351862|NCT03970733|EG000|Reported Event|VLA15 With Alum Lower Dose|"0.75 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180.~VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate"
11351863|NCT03970733|EG001|Reported Event|VLA15 With Alum Higher Dose|1 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
11351864|NCT03970733|EG002|Reported Event|Placebo|1 ml injection of placebo applied at Days 1, 57, and 180. Placebo: phosphate buffered saline (PBS) solution
11351865|NCT03968978|BG000|Baseline|Teze 210 mg Q4W Via APFS|Accessorized pre-filled syringe every 4 weeks administered subcutaneously
11351866|NCT03968978|BG001|Baseline|Teze 210 mg Q4W Via AI|Autoinjector every 4 weeks administered subcutaneously
11351867|NCT03968978|BG002|Baseline|Total|Total of all reporting groups
11351868|NCT03968978|FG000|Participant Flow|Teze 210 mg Q4W Via APFS|Accessorized pre-filled syringe every 4 weeks administered subcutaneously
11351869|NCT03968978|FG001|Participant Flow|Teze 210 mg Q4W Via AI|Autoinjector every 4 weeks administered subcutaneously
11351870|NCT03968978|OG000|Outcome|Teze 210 mg Q4W Via APFS|Accessorized pre-filled syringe every 4 weeks administered subcutaneously
11351871|NCT03968978|OG001|Outcome|Teze 210 mg Q4W Via AI|Autoinjector every 4 weeks administered subcutaneously
11351872|NCT03968978|EG000|Reported Event|Teze 210 mg Q4W Via APFS|Accessorized pre-filled syringe every 4 weeks administered subcutaneously
11351873|NCT03968978|EG001|Reported Event|Teze 210 mg Q4W Via AI|Autoinjector every 4 weeks administered subcutaneously
11351874|NCT03968848|BG000|Baseline|Severe Hepatic Impairment|Subjects with severe hepatic impairment receiving a single dose of 50 mg acalabrutinib (1 x 50 mg capsules)
11351875|NCT03968848|BG001|Baseline|Normal Hepatic Function|Subjects with normal hepatic function receiving a single dose of 50 mg acalabrutinib (1 x 50 mg capsules)
11351876|NCT03968848|BG002|Baseline|Total|Total of all reporting groups
11351877|NCT03968848|FG000|Participant Flow|Severe Hepatic Impairment|Subjects with severe hepatic impairment receiving a single dose of 50 mg acalabrutinib (1 x 50 mg capsules)
11351878|NCT03968848|FG001|Participant Flow|Normal Hepatic Function|Subjects with normal hepatic function receiving a single dose of 50 mg acalabrutinib (1 x 50 mg capsules)
11351879|NCT03968848|OG000|Outcome|Severe Hepatic Impairment|Subjects with severe hepatic impairment receiving a single dose of 50 mg acalabrutinib (1 x 50 mg capsules)
11351880|NCT03968848|OG001|Outcome|Normal Hepatic Function|Subjects with normal hepatic function receiving a single dose of 50 mg acalabrutinib (1 x 50 mg capsules)
11351881|NCT03968848|EG000|Reported Event|Severe Hepatic Impairment|Subjects with severe hepatic impairment receiving a single dose of 50 mg acalabrutinib (1 x 50 mg capsules)
11351882|NCT03968848|EG001|Reported Event|Normal Hepatic Function|Subjects with normal hepatic function receiving a single dose of 50 mg acalabrutinib (1 x 50 mg capsules)
11351883|NCT03967444|BG000|Baseline|Restylane Kysse|"Hyaluronic acid~Hyaluronic acid: Injectable gel for lip augmentation"
11351884|NCT03967444|BG001|Baseline|Restylane Kysse With Other HA|"Hyaluronic acid~Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds"
11351885|NCT03967444|BG002|Baseline|Total|Total of all reporting groups
11351886|NCT03967444|FG000|Participant Flow|Restylane Kysse|"Hyaluronic acid~Hyaluronic acid: Injectable gel for lip augmentation"
11351887|NCT03967444|FG001|Participant Flow|Restylane Kysse With Other HA|"Hyaluronic acid~Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds"
11351888|NCT03967444|OG000|Outcome|Restylane Kysse|"Hyaluronic acid~Hyaluronic acid: Injectable gel for lip augmentation"
11351889|NCT03967444|OG001|Outcome|Restylane Kysse With Other HA|"Hyaluronic acid~Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds"
11351890|NCT03967444|EG000|Reported Event|Restylane Kysse|"Hyaluronic acid~Hyaluronic acid: Injectable gel for lip augmentation"
11351891|NCT03967444|EG001|Reported Event|Restylane Kysse With Other HA|"Hyaluronic acid~Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds"
11351892|NCT03966924|BG000|Baseline|Rotational Fractional Resection (1.5mm Diameter Device)|Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
11351893|NCT03966924|FG000|Participant Flow|Rotational Fractional Resection (1.5mm Diameter Device)|Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
11351894|NCT03966924|OG000|Outcome|Rotational Fractional Resection (1.5mm Diameter Device)|Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
11351895|NCT03966924|EG000|Reported Event|Rotational Fractional Resection (1.5mm Diameter Device)|Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
11351896|NCT03966911|BG000|Baseline|Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)|"Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351897|NCT03966911|BG001|Baseline|Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)|"Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351898|NCT03966911|BG002|Baseline|Total|Total of all reporting groups
11351899|NCT03966911|FG000|Participant Flow|Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)|"Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351900|NCT03966911|FG001|Participant Flow|Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)|"Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351901|NCT03966911|OG000|Outcome|Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Arm|"Adult subjects (age 18-80) wear Guardian™ Sensor (3) on the arm over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351902|NCT03966911|OG001|Outcome|Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Abdomen|"Adult subjects (age 18-80) wear Guardian™ Sensor (3) on the abdomen over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351903|NCT03966911|OG002|Outcome|Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Arm|"Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) on the arm over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351904|NCT03966911|OG003|Outcome|Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Buttock|"Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) on the buttock over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351905|NCT03966911|EG000|Reported Event|Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)|"Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351906|NCT03966911|EG001|Reported Event|Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)|"Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.~Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing"
11351907|NCT03966365|BG000|Baseline|PRO-122|"- Dosage: 1 drop every 12 hours, in both eyes~PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~- Route of administration: topical ophthalmic."
11351908|NCT03966365|BG001|Baseline|Krytantek Ofteno®|"- Dosage: 1 drop every 12 hours, in both eyes~Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~- - Route of administration: topical ophthalmic."
11351909|NCT03966365|BG002|Baseline|Total|Total of all reporting groups
11351910|NCT03966365|FG000|Participant Flow|PRO-122|"- Dosage: 1 drop every 12 hours, in both eyes~PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~- Route of administration: topical ophthalmic."
11167169|NCT01977573|FG002|Participant Flow|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator's opinion] to start rhEPO therapy).
11351911|NCT03966365|FG001|Participant Flow|Krytantek Ofteno®|"- Dosage: 1 drop every 12 hours, in both eyes~Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~- - Route of administration: topical ophthalmic."
11351912|NCT03966365|OG000|Outcome|PRO-122|"- Dosage: 1 drop every 12 hours, in both eyes~PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~- Route of administration: topical ophthalmic."
11351913|NCT03966365|OG001|Outcome|Krytantek Ofteno®|"- Dosage: 1 drop every 12 hours, in both eyes~Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~- - Route of administration: topical ophthalmic."
11351914|NCT03966365|EG000|Reported Event|PRO-122|"- Dosage: 1 drop every 12 hours, in both eyes~PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~- Route of administration: topical ophthalmic."
11351915|NCT03966365|EG001|Reported Event|Krytantek Ofteno®|"- Dosage: 1 drop every 12 hours, in both eyes~Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~- - Route of administration: topical ophthalmic."
11351916|NCT03965403|BG000|Baseline|Arm Motor Function Retraining With BURT|"All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.~Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions"
11351917|NCT03965403|FG000|Participant Flow|Arm Motor Function Retraining With BURT|"All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.~Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions"
11351918|NCT03965403|OG000|Outcome|Arm Motor Function Retraining With BURT|"All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.~Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions"
11351919|NCT03965403|EG000|Reported Event|Arm Motor Function Retraining With BURT|"All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.~Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions"
11351920|NCT03965754|BG000|Baseline|No Email|No email will be sent out to this subset of GHP members during the week that the other emails are sent.
11351921|NCT03965754|BG001|Baseline|Standard Email Reminder|The standard email reminder mentions the average premium savings, the speed and ease of starting the process, and the deadline for registering and having health measures on file, plus it provides two button links for registering and finding free health screenings where health measures can be collected and registered at one convenient time and location.
11351922|NCT03965754|BG002|Baseline|Social Norms Email|The social norms email notes that a majority (78%) of GHP members' colleagues had enrolled in 2018, it provides a testimonial from a medical director at Geisinger's Commonwealth School of Medicine, stating the ways in which myHealth Rewards helped that doctor personally, and it emphasizes the simplicity and ease of taking the first step toward enrollment.
11351923|NCT03965754|BG003|Baseline|Loss Framing|"The loss framing email suggests that GHP members are currently throwing away a precise dollar amount (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action."
11351924|NCT03965754|BG004|Baseline|Total|Total of all reporting groups
11351925|NCT03965754|FG000|Participant Flow|No Email|No email will be sent out to this subset of GHP members during the week that the other emails are sent.
11351926|NCT03965754|FG001|Participant Flow|Standard Email Reminder|The standard email reminder mentions the average premium savings, the speed and ease of starting the process, and the deadline for registering and having health measures on file, plus it provides two button links for registering and finding free health screenings where health measures can be collected and registered at one convenient time and location.
11351927|NCT03965754|FG002|Participant Flow|Social Norms Email|The social norms email notes that a majority (78%) of GHP members' colleagues had enrolled in 2018, it provides a testimonial from a medical director at Geisinger's Commonwealth School of Medicine, stating the ways in which myHealth Rewards helped that doctor personally, and it emphasizes the simplicity and ease of taking the first step toward enrollment.
11351928|NCT03965754|FG003|Participant Flow|Loss Framing|"The loss framing email suggests that GHP members are currently throwing away a precise dollar amount (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action."
11351929|NCT03965754|OG000|Outcome|No Email|No email will be sent out to this subset of GHP members during the week that the other emails are sent.
11351930|NCT03965754|OG001|Outcome|Standard Email Reminder|The standard email reminder mentions the average premium savings, the speed and ease of starting the process, and the deadline for registering and having health measures on file, plus it provides two button links for registering and finding free health screenings where health measures can be collected and registered at one convenient time and location.
11351931|NCT03965754|OG002|Outcome|Social Norms Email|The social norms email notes that a majority (78%) of GHP members' colleagues had enrolled in 2018, it provides a testimonial from a medical director at Geisinger's Commonwealth School of Medicine, stating the ways in which myHealth Rewards helped that doctor personally, and it emphasizes the simplicity and ease of taking the first step toward enrollment.
11351932|NCT03965754|OG003|Outcome|Loss Framing|"The loss framing email suggests that GHP members are currently throwing away a precise dollar amount (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action."
11351933|NCT03965754|EG000|Reported Event|No Email|No email will be sent out to this subset of GHP members during the week that the other emails are sent.
11351934|NCT03965754|EG001|Reported Event|Standard Email Reminder|The standard email reminder mentions the average premium savings, the speed and ease of starting the process, and the deadline for registering and having health measures on file, plus it provides two button links for registering and finding free health screenings where health measures can be collected and registered at one convenient time and location.
11351935|NCT03965754|EG002|Reported Event|Social Norms Email|The social norms email notes that a majority (78%) of GHP members' colleagues had enrolled in 2018, it provides a testimonial from a medical director at Geisinger's Commonwealth School of Medicine, stating the ways in which myHealth Rewards helped that doctor personally, and it emphasizes the simplicity and ease of taking the first step toward enrollment.
11351936|NCT03965754|EG003|Reported Event|Loss Framing|"The loss framing email suggests that GHP members are currently throwing away a precise dollar amount (over $2,000) by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action."
11351937|NCT03965533|BG000|Baseline|Part A: Placebo IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of 0.9% weight by volume (w/v) saline placebo.
11351938|NCT03965533|BG001|Baseline|Part A: GSK2831781 450 mg IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of GSK2831781 at a dose of 450 milligram (mg), diluted in 0.9% w/v saline.
11351939|NCT03965533|BG002|Baseline|Part A: Placebo IV- Japanese Participants|Japanese male participants were administered a single IV infusion of 0.9% w/v saline placebo.
11351940|NCT03965533|BG003|Baseline|Part A: GSK2831781 450 mg IV- Japanese Participants|Japanese male participants were administered a single IV infusion of GSK2831781 at a dose of 450 mg, diluted in 0.9% w/v saline.
11351941|NCT03965533|BG004|Baseline|Part B: Placebo SC|Caucasian male participants were administered three SC injections of 0.9% w/v saline placebo.
11351942|NCT03965533|BG005|Baseline|Part B: GSK2831781 150 mg SC|Arm Description: Caucasian male participants were administered a single SC injection of a unit dose strength of 150 mg per milliliter (mL) of GSK2831781, diluted in 0.9% w/v saline. Participants also received 2 dummy injections of 0.9% w/v saline placebo SC to maintain the blinding.
11351943|NCT03965533|BG006|Baseline|Part B: GSK2831781 450 mg SC|Caucasian male participants were administered three SC injections of a unit dose strength of 150 mg per mL of GSK2831781 to achieve a dose of 450 mg.
11351944|NCT03965533|BG007|Baseline|Total|Total of all reporting groups
11351945|NCT03965533|FG000|Participant Flow|Part A: Placebo IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of 0.9% weight by volume (w/v) saline placebo.
11351946|NCT03965533|FG001|Participant Flow|Part A: GSK2831781 450 mg IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of GSK2831781 at a dose of 450 milligram (mg), diluted in 0.9% w/v saline.
11351947|NCT03965533|FG002|Participant Flow|Part A: Placebo IV- Japanese Participants|Japanese male participants were administered a single IV infusion of 0.9% w/v saline placebo.
11351948|NCT03965533|FG003|Participant Flow|Part A: GSK2831781 450 mg IV- Japanese Participants|Japanese male participants were administered a single IV infusion of GSK2831781 at a dose of 450 mg, diluted in 0.9% w/v saline.
11351949|NCT03965533|FG004|Participant Flow|Part B: Placebo SC|Caucasian male participants were administered three SC injections of 0.9% w/v saline placebo.
11351950|NCT03965533|FG005|Participant Flow|Part B: GSK2831781 150 mg SC|Arm Description: Caucasian male participants were administered a single SC injection of a unit dose strength of 150 mg per milliliter (mL) of GSK2831781, diluted in 0.9% w/v saline. Participants also received 2 dummy injections of 0.9% w/v saline placebo SC to maintain the blinding.
11351951|NCT03965533|FG006|Participant Flow|Part B: GSK2831781 450 mg SC|Caucasian male participants were administered three SC injections of a unit dose strength of 150 mg per mL of GSK2831781 to achieve a dose of 450 mg.
11351952|NCT03965533|OG000|Outcome|Part A: Placebo IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of 0.9% weight by volume (w/v) saline placebo.
11351953|NCT03965533|OG001|Outcome|Part A: GSK2831781 450 mg IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of GSK2831781 at a dose of 450 milligram (mg), diluted in 0.9% w/v saline.
11351954|NCT03965533|OG002|Outcome|Part A: Placebo IV- Japanese Participants|Japanese male participants were administered a single IV infusion of 0.9% w/v saline placebo.
11167170|NCT01977573|FG003|Participant Flow|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
11351955|NCT03965533|OG003|Outcome|Part A: GSK2831781 450 mg IV- Japanese Participants|Japanese male participants were administered a single IV infusion of GSK2831781 at a dose of 450 mg, diluted in 0.9% w/v saline.
11351956|NCT03965533|OG000|Outcome|Part B: Placebo SC|Caucasian male participants were administered three SC injections of 0.9% w/v saline placebo.
11351957|NCT03965533|OG001|Outcome|Part B: GSK2831781 150 mg SC|Caucasian male participants were administered a single SC injection of a unit dose strength of 150 mg per milliliter (mL) of GSK2831781, diluted in 0.9% w/v saline. Participants also received 2 dummy injections of 0.9% w/v saline placebo SC to maintain the blinding.
11351958|NCT03965533|OG002|Outcome|Part B: GSK2831781 450 mg SC|Caucasian male participants were administered three SC injections of a unit dose strength of 150 mg per mL of GSK2831781 to achieve a dose of 450 mg.
11351959|NCT03965533|OG000|Outcome|Part A: GSK2831781 450 mg IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of GSK2831781 at a dose of 450 milligram (mg), diluted in 0.9% w/v saline.
11351960|NCT03965533|OG001|Outcome|Part A: GSK2831781 450 mg IV- Japanese Participants|Japanese male participants were administered a single IV infusion of GSK2831781 at a dose of 450 mg, diluted in 0.9% w/v saline.
11351961|NCT03965533|OG000|Outcome|Part B: GSK2831781 150 mg SC|Caucasian male participants were administered a single SC injection of a unit dose strength of 150 mg per milliliter (mL) of GSK2831781, diluted in 0.9% w/v saline. Participants also received 2 dummy injections of 0.9% w/v saline placebo SC to maintain the blinding.
11351962|NCT03965533|OG001|Outcome|Part B: GSK2831781 450 mg SC|Caucasian male participants were administered three SC injections of a unit dose strength of 150 mg per mL of GSK2831781 to achieve a dose of 450 mg.
11351963|NCT03965533|OG000|Outcome|Part A and Part B: All Participants|In Part A, Caucasian and Japanese male participants were administered a single IV infusion of GSK2831781 at a dose of 450 mg, diluted in 0.9% w/v saline. In Part B, Caucasian male participants were administered a single SC injection of a unit dose strength of 150 mg per mL of GSK2831781, diluted in 0.9% w/v saline and also received 2 dummy injections of 0.9% w/v saline placebo SC to maintain the blinding. To achieve a dose of 450 mg, Caucasian male participants were administered three SC injections of a unit dose strength of 150 mg per mL of GSK2831781.
11351964|NCT03965533|EG000|Reported Event|Part A: Placebo IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of 0.9% weight by volume (w/v) saline placebo.
11351965|NCT03965533|EG001|Reported Event|Part A: GSK2831781 450 mg IV- Caucasian Participants|Caucasian male participants were administered a single IV infusion of GSK2831781 at a dose of 450 milligram (mg), diluted in 0.9% w/v saline.
11351966|NCT03965533|EG002|Reported Event|Part A: Placebo IV- Japanese Participants|Japanese male participants were administered a single IV infusion of 0.9% w/v saline placebo.
11351967|NCT03965533|EG003|Reported Event|Part A: GSK2831781 450 mg IV- Japanese Participants|Japanese male participants were administered a single IV infusion of GSK2831781 at a dose of 450 mg, diluted in 0.9% w/v saline.
11351968|NCT03965533|EG004|Reported Event|Part B: Placebo SC|Caucasian male participants were administered three SC injections of 0.9% w/v saline placebo.
10887880|NCT00503685|OG000|Outcome|IMC-A12 + Cetuximab (K-ras Wild-type)|"Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.~Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent."
10887881|NCT00503685|EG000|Reported Event|IMC-A12|Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10887882|NCT00503685|EG001|Reported Event|IMC-A12 + Cetuximab|Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
11167171|NCT01977573|OG000|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
11230416|NCT02405442|EG006|Reported Event|Open-Label Andecaliximab QW From Andecaliximab 300 mg QW|Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 300 mg Every 2 Weeks group.
11230417|NCT02405442|EG007|Reported Event|Open-Label Andecaliximab QW From Placebo|Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Placebo group.
11230418|NCT02405780|BG000|Baseline|FKB327-FKB327|This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to receive FKB327 in Study FKB327-003.
11230419|NCT02405780|BG001|Baseline|FKB327-Humira|This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to receive the reference product Humira in Study FKB327-003.
11230420|NCT02405780|BG002|Baseline|Humira-FKB327|This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to receive FKB327 in Study FKB327-003.
11230421|NCT02405780|BG003|Baseline|Humira-Humira|This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to receive the reference product Humira in Study FKB327-003.
11230422|NCT02405780|BG004|Baseline|Total|Total of all reporting groups
11230423|NCT02405780|FG000|Participant Flow|FKB327-FKB327-FKB327|"Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to FKB327 in Period I of study FKB327-003 (F-F).~Period II: From week 30 all subjects received FKB327; (F-F-F)."
11230424|NCT02405780|FG001|Participant Flow|FKB327-Humira-FKB327|"Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study FKB327-002 and were re-randomized to the reference product, Humira, during Period I of study FKB327-003 (F-H).~Period II: From week 30 all subjects received FKB327; (F-H-F)."
11230425|NCT02405780|FG002|Participant Flow|Humira-FKB327-FKB327|"Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to FKB327 during Period I of study FKB327-003 (H-F).~Period II: From week 30 all subjects received FKB327; (H-F-F)."
11230426|NCT02405780|FG003|Participant Flow|Humira-Humira-FKB327|"Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002, and were re-randomized to the reference product Humira during Period I of study FKB327-003 (H-H).~Period II: From week 30 all subjects received FKB327; (H-H-F)."
11230427|NCT02405780|OG000|Outcome|FKB327-FKB327|Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to FKB327 in Period I of study FKB327-003 (F-F).
11230428|NCT02405780|OG001|Outcome|FKB327-Humira|Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study FKB327-002 and were re-randomized to the reference product, Humira, during Period I of study FKB327-003 (F-H).
11230429|NCT02405780|OG002|Outcome|Humira-FKB327|Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to FKB327 during Period I of study FKB327-003 (H-F).
11230430|NCT02405780|OG003|Outcome|Humira-Humira|Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002, and were re-randomized to the reference product Humira during Period I of study FKB327-003 (H-H).
11230431|NCT02405780|OG000|Outcome|FKB327|"Period II: From week 30 all patients received one subcutaneous injection every other week of 40 mg/0.8 mL presented in an auto-injector (AI) or in a pre-filled syringe (PFS).~Based on the design of the study and to what treatment groups the subjects were randomised to in Period I, some patients received continuous treatment with FKB327 40 mg/0.8mL every other week by subcutaneous injection for up to 76 weeks. This was applicable to subjects in treatment groups (F-F-F) and (H-F-F)"
11230432|NCT02405780|OG000|Outcome|FKB327|"Period II: From week 30 all subjects received one subcutaneous injection every other week of FKB327 40 mg/0.8 mL presented in an auto-injector (AI) or in a pre-filled syringe (PFS) .~Based on the design of the study and to what treatment groups the subjects were randomised to in Period I, some patients received continuous treatment with FKB327 40 mg/0.8mL every other week by subcutaneous injection for up to 76 weeks. This was applicable to subjects in treatment groups (F-F-F) and (H-F-F)"
11230433|NCT02405780|OG000|Outcome|FKB327-FKB327-FKB327|"Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to receive FKB327 in Study FKB327-003 (F-F).~Period II: From week 30 all subjects received FKB327 (F-F-F)."
11167172|NCT01977573|OG001|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator's clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
11167173|NCT01977573|OG002|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator's opinion] to start rhEPO therapy).
11167174|NCT01977573|OG003|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
11167175|NCT01977573|OG001|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator's opinion] to start rhEPO therapy).
11167176|NCT01977573|EG000|Reported Event|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
11167177|NCT01977573|EG001|Reported Event|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator's clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
11167178|NCT01977573|EG002|Reported Event|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator's opinion] to start rhEPO therapy).
11167179|NCT01977573|EG003|Reported Event|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
11167180|NCT01977599|BG000|Baseline|No Text Message Reminder (Control) Arm|Control Arm, in which patients are invited to breast screening as per standard West of London Breast Screening Protocol (i.e. without a text message appointment reminder). Uptake of breast screening in this group will be compared with the text message reminder group to test for significant differences.
11167181|NCT01977599|BG001|Baseline|Text Message Reminder Arm|"Patients randomly allocated to this arm of the study will be sent a text message reminding them of the time, date and venue of their breast screening appointment 48 hours in advance.~Text Message Reminder for Breast Screening Appointment: Non-clinical/administrative."
11167182|NCT01977599|BG002|Baseline|Total|Total of all reporting groups
11167183|NCT01977599|FG000|Participant Flow|No Text Message Reminder (Control) Arm|Control Arm, in which patients are invited to breast screening as per standard West of London Breast Screening Protocol (i.e. without a text message appointment reminder). Uptake of breast screening in this group will be compared with the text message reminder group to test for significant differences.
11167184|NCT01977599|FG001|Participant Flow|Text Message Reminder Arm|"Patients randomly allocated to this arm of the study will be sent a text message reminding them of the time, date and venue of their breast screening appointment 48 hours in advance.~Text Message Reminder for Breast Screening Appointment: Non-clinical/administrative."
11167185|NCT01977599|OG000|Outcome|No Text Message Reminder (Control) Arm|Control Arm, in which patients are invited to breast screening as per standard West of London Breast Screening Protocol (i.e. without a text message appointment reminder). Uptake of breast screening in this group will be compared with the text message reminder group to test for significant differences.
11167186|NCT01977599|OG001|Outcome|Text Message Reminder Arm|"Patients randomly allocated to this arm of the study will be sent a text message reminding them of the time, date and venue of their breast screening appointment 48 hours in advance.~Text Message Reminder for Breast Screening Appointment: Non-clinical/administrative."
11167187|NCT01977599|EG000|Reported Event|No Text Message Reminder (Control) Arm|Control Arm, in which patients are invited to breast screening as per standard West of London Breast Screening Protocol (i.e. without a text message appointment reminder). Uptake of breast screening in this group will be compared with the text message reminder group to test for significant differences.
11167188|NCT01977599|EG001|Reported Event|Text Message Reminder Arm|"Patients randomly allocated to this arm of the study will be sent a text message reminding them of the time, date and venue of their breast screening appointment 48 hours in advance.~Text Message Reminder for Breast Screening Appointment: Non-clinical/administrative."
11167189|NCT01977612|BG000|Baseline|Stainless Steel Staples|Skin closure using stainless steel staples.
11167190|NCT01977612|BG001|Baseline|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
11167191|NCT01977612|BG002|Baseline|Total|Total of all reporting groups
11167192|NCT01977612|FG000|Participant Flow|Stainless Steel Staples|Skin closure using stainless steel staples.
11167193|NCT01977612|FG001|Participant Flow|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
11167194|NCT01977612|OG000|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
11167195|NCT01977612|OG001|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
11167196|NCT01977612|EG000|Reported Event|Stainless Steel Staples|Skin closure using stainless steel staples.
11167197|NCT01977612|EG001|Reported Event|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
11167198|NCT01977625|BG000|Baseline|All Participants|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
11167199|NCT01977625|FG000|Participant Flow|Lisdexamfetamine, Then Placebo|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
11167200|NCT01977625|FG001|Participant Flow|Placebo, Then Lisdexamfetamine|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks..
11167201|NCT01977625|OG000|Outcome|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse~Lisdexamfetamine: The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women."
11167202|NCT01977625|OG001|Outcome|Placebo|"Placebo pill, capsules~Placebo: To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women."
11167203|NCT01977625|OG000|Outcome|Lisdexamfetamine|14 participants completed all 3 scans.
11167204|NCT01977625|OG001|Outcome|Placebo|14 participants completed all 3 scans.
11167205|NCT01977625|EG000|Reported Event|Lisdexamfetamine|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
11167206|NCT01977625|EG001|Reported Event|Placebo|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks.
11167207|NCT01977651|BG000|Baseline|Enzalutamide 160 mg|Participants received 160 mg of enzalutamide orally once a day, for 4 months.
11167208|NCT01977651|FG000|Participant Flow|Enzalutamide 160 mg|Participants received 160 mg of enzalutamide orally once a day, for 4 months. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment continued in the extension period. The total study drug treatment duration for the extended period depended on individual clinical benefit. If a participant experienced a Grade 3 or higher toxicity that was attributed to enzalutamide and could not be ameliorated by the use of adequate medical intervention, treatment with enzalutamide was allowed to be interrupted for 1 week or until the toxicity grade improved to Grade 2 or lower severity. Subsequently, enzalutamide was restarted at the original dose 160 mg per day or a reduced dose 120 or 80 mg per day in consultation with the medical monitor.
11167209|NCT01977651|OG000|Outcome|Enzalutamide 160 mg|Participants received 160 mg of enzalutamide orally once a day, for 4 months.
11167210|NCT01977651|EG000|Reported Event|Enzalutamide 160 mg|Participants received 160 mg of enzalutamide orally once a day, for 4 months. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment continued in the extension period. The total study drug treatment duration for the extended period depended on individual clinical benefit. If a participant experienced a Grade 3 or higher toxicity that was attributed to enzalutamide and could not be ameliorated by the use of adequate medical intervention, treatment with enzalutamide was allowed to be interrupted for 1 week or until the toxicity grade improved to Grade 2 or lower severity. Subsequently, enzalutamide was restarted at the original dose 160 mg per day or a reduced dose 120 or 80 mg per day in consultation with the medical monitor.
11167211|NCT01977677|BG000|Baseline|Escalation: Plerixafor 200 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
11167212|NCT01977677|BG001|Baseline|Escalation: Plerixafor 400 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
11167213|NCT01977677|BG002|Baseline|Expansion: Plerixafor 400 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
11167214|NCT01977677|BG003|Baseline|Total|Total of all reporting groups
11167215|NCT01977677|FG000|Participant Flow|Escalation: Plerixafor 200 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
11167216|NCT01977677|FG001|Participant Flow|Escalation: Plerixafor 400 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
11167217|NCT01977677|FG002|Participant Flow|Expansion: Plerixafor 400 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
11167218|NCT01977677|OG000|Outcome|Escalation: Plerixafor 200 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
11167219|NCT01977677|OG001|Outcome|Escalation: Plerixafor 400 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
11351969|NCT03965533|EG005|Reported Event|Part B: GSK2831781 150 mg SC|Caucasian male participants were administered a single SC injection of a unit dose strength of 150 mg per milliliter (mL) of GSK2831781, diluted in 0.9% w/v saline. Participants also received 2 dummy injections of 0.9% w/v saline placebo SC to maintain the blinding.
11351970|NCT03965533|EG006|Reported Event|Part B: GSK2831781 450 mg SC|Caucasian male participants were administered three SC injections of a unit dose strength of 150 mg per mL of GSK2831781 to achieve a dose of 450 mg.
11351971|NCT03965351|BG000|Baseline|Probenecid, Then Placebo|"the study medication (probenecid) as well as a placebo.~Probenecid: This is a cross-over pilot study where participants will receive both the study medication (probenecid), as well as a placebo to see if the study medication improves magnetic resonance parameters of systolic and diastolic dysfunction that occurs in the Fontan population.~Placebo: placebo"
11351972|NCT03965351|BG001|Baseline|Placebo, Then Probenecid|"placebo compared to probenecid~Probenecid: This is a cross-over pilot study where participants will receive both the study medication (probenecid), as well as a placebo to see if the study medication improves magnetic resonance parameters of systolic and diastolic dysfunction that occurs in the Fontan population.~Placebo: placebo"
11351973|NCT03965351|BG002|Baseline|Total|Total of all reporting groups
11351974|NCT03965351|FG000|Participant Flow|Probenecid, and Then Placebo|"All patients will have a baseline assessment immediately preceding initiation of probenecid or placebo. This will include a physical exam to assess any clinical symptoms, review of cardiac symptoms, blood work, pregnancy test for those girls/women of child bearing potential, PEDS QL questionnaire completion, exercise testing and MRI, as described in detail below. Patients will then receive either probenecid or placebo for 28(±7 days) of treatment according to their randomization group, after which the same testing will be repeated. Following 28(±7 days) of washout, patients will undergo the same testing procedures as during the first period of study but with the alternate treatment. To assist in achieving congruence between clinical testing performed and desired pre-intervention testing, we will coordinate with each patient and his/her cardiologist prior to the clinical visit.~Patients will receive a one month supply of oral probenecid therapy with the following dosing regimen:~For patients (adults and pediatric) ≥ 40 kg: 500 mg by mouth twice daily.~For children 10-17 years old and < 40 kg: 250 mg by mouth twice daily~During the placebo treatment arm, patients will receive 28(±7 days) of placebo therapy. Oral placebo therapy will be twice daily, with an identical dosing regimen as the placebo."
11351975|NCT03965351|FG001|Participant Flow|Placebo, and Then Probenecid|"All patients will have a baseline assessment immediately preceding initiation of probenecid or placebo. This will include a physical exam to assess any clinical symptoms, review of cardiac symptoms, blood work, pregnancy test for those girls/women of child bearing potential, PEDS QL questionnaire completion, exercise testing and MRI, as described in detail below. Patients will then receive either probenecid or placebo for 28(±7 days) of treatment according to their randomization group, after which the same testing will be repeated. Following 28(±7 days) of washout, patients will undergo the same testing procedures as during the first period of study but with the alternate treatment. To assist in achieving congruence between clinical testing performed and desired pre-intervention testing, we will coordinate with each patient and his/her cardiologist prior to the clinical visit.~Patients will receive a one month supply of oral probenecid therapy with the following dosing regimen:~For patients (adults and pediatric) ≥ 40 kg: 500 mg by mouth twice daily.~For children 10-17 years old and < 40 kg: 250 mg by mouth twice daily~During the placebo treatment arm, patients will receive 28(±7 days) of placebo therapy. Oral placebo therapy will be twice daily, with an identical dosing regimen as the placebo."
11351976|NCT03965351|OG000|Outcome|Probenecid|This is a cross-over pilot study. Results are indicative of subject response when receiving the study medication (probenecid).
11351977|NCT03965351|OG001|Outcome|Placebo|This is a cross-over pilot study. Results are indicative of subject response when receiving the placebo medication.
11351978|NCT03965351|EG000|Reported Event|Probenecid|Participants in this arm were randomly assigned to receive probenecid (study medication) during the first phase, then went through a washout phase, and finally received a placebo during the last phase.
11351979|NCT03965351|EG001|Reported Event|Placebo|Participants in this arm were randomly assigned to receive placebo during the first phase, then went through a washout phase, and finally received the study medication, probenecid, during the last phase.
11351980|NCT03964220|BG000|Baseline|Tiotropium Respimat® (Tio Group)|"1.25 microgram (mcg) of solution of inhalation of Tiotropium Respimat® added-on to Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) therapy.~Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg))."
11351981|NCT03964220|BG001|Baseline|Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)|"Low dose ICS/LABA to medium/high dose ICS/LABA or from baseline medium dose ICS/LABA to high dose ICS/LABA or an additional prescription/refill of high-dose ICS/LABA following the first prescription of baseline high dose ICS/LABA within the study period.~Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg))."
11167220|NCT01977677|OG002|Outcome|Expansion: Plerixafor 400 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
11351982|NCT03964220|BG002|Baseline|Total|Total of all reporting groups
11167221|NCT01977677|EG000|Reported Event|Escalation: Plerixafor 200 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
11167222|NCT01977677|EG001|Reported Event|Escalation: Plerixafor 400 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
11167223|NCT01977677|EG002|Reported Event|Expansion: Plerixafor 400 mcg/kg/Day|One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
11167224|NCT01977690|BG000|Baseline|Standard Management|Every patient routinely received narcotic and non-narcotic pain medication on an as-needed basis in the hospital. No nonsteroidal anti-inflammatory drugs, such as ibuprofen or ketorolac, were given.
11167225|NCT01977690|BG001|Baseline|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.~Clavicle Brace"
11167226|NCT01977690|BG002|Baseline|Total|Total of all reporting groups
11167227|NCT01977690|FG000|Participant Flow|Standard Management|Patients received analgesics ad libitum
11167228|NCT01977690|FG001|Participant Flow|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.~Clavicle Brace"
11167229|NCT01977690|OG000|Outcome|Standard Management|Patients received analgesics ad libitum
11167230|NCT01977690|OG001|Outcome|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.~Clavicle Brace"
11167231|NCT01977690|EG000|Reported Event|Standard Management|Patients received analgesic ad libitum
11167232|NCT01977690|EG001|Reported Event|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.~Clavicle Brace"
11167233|NCT01977781|BG000|Baseline|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
11167234|NCT01977781|BG001|Baseline|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
11167235|NCT01977781|BG002|Baseline|Total|Total of all reporting groups
11167236|NCT01977781|FG000|Participant Flow|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
11167237|NCT01977781|FG001|Participant Flow|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
11167238|NCT01977781|OG000|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
11167239|NCT01977781|OG001|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
11167240|NCT01977781|EG000|Reported Event|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
11230434|NCT02405780|OG001|Outcome|FKB327-Humira-FKB327|"Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to receive the reference product Humira in Study FKB327-003 (F-H).~Period II: From week 30 all subjects received FKB327 (F-H-F)."
11351983|NCT03964220|FG000|Participant Flow|Tiotropium Respimat® (Tio Group)|"1.25 microgram (mcg) of solution of inhalation of Tiotropium Respimat® added-on to Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) therapy.~Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg))."
11351984|NCT03964220|FG001|Participant Flow|Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)|"Low dose ICS/LABA to medium/high dose ICS/LABA or from baseline medium dose ICS/LABA to high dose ICS/LABA or an additional prescription/refill of high-dose ICS/LABA following the first prescription of baseline high dose ICS/LABA within the study period.~Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg))."
11351985|NCT03964220|OG000|Outcome|Tiotropium Respimat® (Tio Group)|"1.25 microgram (mcg) of solution of inhalation of Tiotropium Respimat® added-on to Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) therapy.~Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg))."
11351986|NCT03964220|OG001|Outcome|Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)|"Low dose ICS/LABA to medium/high dose ICS/LABA or from baseline medium dose ICS/LABA to high dose ICS/LABA or an additional prescription/refill of high-dose ICS/LABA following the first prescription of baseline high dose ICS/LABA within the study period.~Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg))."
11351987|NCT03964220|EG000|Reported Event|Tiotropium Respimat® (Tio Group)|"1.25 microgram (mcg) of solution of inhalation of Tiotropium Respimat® added-on to Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) therapy.~Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg))."
11351988|NCT03964220|EG001|Reported Event|Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)|"Low dose ICS/LABA to medium/high dose ICS/LABA or from baseline medium dose ICS/LABA to high dose ICS/LABA or an additional prescription/refill of high-dose ICS/LABA following the first prescription of baseline high dose ICS/LABA within the study period.~Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg))."
11351989|NCT03958955|BG000|Baseline|All Randomised Subjects|"Randomised subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks.~Delgocitinib cream 20 mg/g: Cream for topical application.~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11351990|NCT03958955|FG000|Participant Flow|All Subjects|"All 27 subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks.~Delgocitinib cream 20 mg/g: Cream for topical application.~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11351991|NCT03958955|OG000|Outcome|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 6 weeks~Delgocitinib cream: Cream for topical application."
11351992|NCT03958955|OG001|Outcome|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 6 weeks~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11351993|NCT03958955|OG000|Outcome|All Subjects|"All subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks.~Delgocitinib cream 20 mg/g: Cream for topical application.~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11351994|NCT03958955|EG000|Reported Event|All Subjects|"All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.~Delgocitinib cream 20 mg/g: Cream for topical application.~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11351995|NCT03965052|BG000|Baseline|PRO-179|"Dosage: 1 drop every 24 hours, at night, in both eyes.~PRO 179: o Generic name: Travoprost~Distinctive denomination: Bristrio® (PRO-179)~Active principles: Travoprost 0.004%.~Pharmaceutical form: Ophthalmic solution~Presentation: multi-dose dropper bottle, 2.5 milliliters.~Prepared by: Sophia Laboratories, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene."
11351996|NCT03965052|BG001|Baseline|Travatan®|"Dosage: 1 drop every 24 hours, at night, in both eyes.~Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost~Distinctive denomination: Travatan®~Active ingredients: Travoprost 0.004%~Pharmaceutical form: Ophthalmic solution.~Presentation: multi-dose dropper bottle, 2.5 milliliters.~Prepared by: Alcon Laboratories Inc.~Description of the solution: transparent solution, free of visible particles.~Consult information to prescribe."
11351997|NCT03965052|BG002|Baseline|Total|Total of all reporting groups
11351998|NCT03965052|FG000|Participant Flow|PRO-179|"Dosage: 1 drop every 24 hours, at night, in both eyes.~PRO 179: o Generic name: Travoprost~Distinctive denomination: Bristrio® (PRO-179)~Active principles: Travoprost 0.004%.~Pharmaceutical form: Ophthalmic solution~Presentation: multi-dose dropper bottle, 2.5 milliliters.~Prepared by: Sophia Laboratories, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene."
11351999|NCT03965052|FG001|Participant Flow|Travatan®|"Dosage: 1 drop every 24 hours, at night, in both eyes.~Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost~Distinctive denomination: Travatan®~Active ingredients: Travoprost 0.004%~Pharmaceutical form: Ophthalmic solution.~Presentation: multi-dose dropper bottle, 2.5 milliliters.~Prepared by: Alcon Laboratories Inc.~Description of the solution: transparent solution, free of visible particles.~Consult information to prescribe."
11352000|NCT03965052|OG000|Outcome|PRO-179|"Dosage: 1 drop every 24 hours, at night, in both eyes.~PRO 179: o Generic name: Travoprost~Distinctive denomination: Bristrio® (PRO-179)~Active principles: Travoprost 0.004%.~Pharmaceutical form: Ophthalmic solution~Presentation: multi-dose dropper bottle, 2.5 milliliters.~Prepared by: Sophia Laboratories, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene."
11352001|NCT03965052|OG001|Outcome|Travatan®|"Dosage: 1 drop every 24 hours, at night, in both eyes.~Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost~Distinctive denomination: Travatan®~Active ingredients: Travoprost 0.004%~Pharmaceutical form: Ophthalmic solution.~Presentation: multi-dose dropper bottle, 2.5 milliliters.~Prepared by: Alcon Laboratories Inc.~Description of the solution: transparent solution, free of visible particles.~Consult information to prescribe."
11352002|NCT03965052|EG000|Reported Event|PRO-179|"Dosage: 1 drop every 24 hours, at night, in both eyes.~PRO 179: o Generic name: Travoprost~Distinctive denomination: Bristrio® (PRO-179)~Active principles: Travoprost 0.004%.~Pharmaceutical form: Ophthalmic solution~Presentation: multi-dose dropper bottle, 2.5 milliliters.~Prepared by: Sophia Laboratories, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene."
11352003|NCT03965052|EG001|Reported Event|Travatan®|"Dosage: 1 drop every 24 hours, at night, in both eyes.~Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost~Distinctive denomination: Travatan®~Active ingredients: Travoprost 0.004%~Pharmaceutical form: Ophthalmic solution.~Presentation: multi-dose dropper bottle, 2.5 milliliters.~Prepared by: Alcon Laboratories Inc.~Description of the solution: transparent solution, free of visible particles.~Consult information to prescribe."
11352004|NCT03965039|BG000|Baseline|Marketed Stannous Fluoride Toothpaste|"Brush twice daily~Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste"
11352005|NCT03965039|BG001|Baseline|Marketed Potassium Nitrate Toothpaste|"Brush Twice Daily~Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste"
11352006|NCT03965039|BG002|Baseline|Marketed Sodium Monofluorophosphate Toothpaste|"Brush Twice Daily~Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste"
11352007|NCT03965039|BG003|Baseline|Experimental Dipotassium Oxalate Toothpaste|"Brush Twice Daily~Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste"
11352008|NCT03965039|BG004|Baseline|Total|Total of all reporting groups
11352009|NCT03965039|FG000|Participant Flow|Marketed Stannous Fluoride Toothpaste|"Brush twice daily~Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste"
11352010|NCT03965039|FG001|Participant Flow|Marketed Potassium Nitrate Toothpaste|"Brush Twice Daily~Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste"
10887883|NCT00503685|EG002|Reported Event|IMC-A12 + Cetuximab (K-ras Wild-type)|"Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.~Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent."
10887884|NCT00503698|BG000|Baseline|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
10887885|NCT00503698|BG001|Baseline|Placebo|Placebo once daily, week 0 to end of trial
10887886|NCT00503698|BG002|Baseline|Total|Total of all reporting groups
10887887|NCT00503698|FG000|Participant Flow|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
10887888|NCT00503698|FG001|Participant Flow|Placebo|Placebo once daily, week 0 to end of trial
10887889|NCT00503698|OG000|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
10887890|NCT00503698|OG001|Outcome|Placebo|Placebo once daily, week 0 to end of trial
11352011|NCT03965039|FG002|Participant Flow|Marketed Sodium Monofluorophosphate Toothpaste|"Brush Twice Daily~Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste"
11352012|NCT03965039|FG003|Participant Flow|Experimental Dipotassium Oxalate Toothpaste|"Brush Twice Daily~Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste"
11352013|NCT03965039|OG000|Outcome|Marketed Stannous Fluoride Toothpaste|"Brush twice daily~Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste"
11352014|NCT03965039|OG001|Outcome|Marketed Potassium Nitrate Toothpaste|"Brush Twice Daily~Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste"
11352015|NCT03965039|OG002|Outcome|Marketed Sodium Monofluorophosphate Toothpaste|"Brush Twice Daily~Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste"
11352016|NCT03965039|OG003|Outcome|Experimental Dipotassium Oxalate Toothpaste|"Brush Twice Daily~Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste"
11352017|NCT03965039|EG000|Reported Event|Marketed Stannous Fluoride Toothpaste|"Brush twice daily~Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste"
11352018|NCT03965039|EG001|Reported Event|Marketed Potassium Nitrate Toothpaste|"Brush Twice Daily~Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste"
11352019|NCT03965039|EG002|Reported Event|Marketed Sodium Monofluorophosphate Toothpaste|"Brush Twice Daily~Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste"
11230435|NCT02405780|OG002|Outcome|Humira-FKB327-FKB327|"Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to receive FKB327 in Study FKB327-003 (H-F).~Period II: From week 30 all subjects received FKB327 (H-F-F)."
11230436|NCT02405780|OG003|Outcome|Humira-Humira-FKB327|"Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to receive the reference product Humira in Study FKB327-003 (H-H).~Period II: From week 30 all subjects received FKB327 (H-H-F)."
10887891|NCT00503698|EG000|Reported Event|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
11230437|NCT02405780|OG000|Outcome|FKB327-FKB327|Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to receive FKB327 in Study FKB327-003 (F-F).
11230438|NCT02405780|OG001|Outcome|FKB327-Humira|Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to receive the reference product Humira in Study FKB327-003 (F-H).
11230439|NCT02405780|OG002|Outcome|Humira-FKB327|Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to receive FKB327 in Study FKB327-003 (H-F).
11230440|NCT02405780|OG003|Outcome|Humira-Humira|Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to receive the reference product Humira in Study FKB327-003 (H-H).
11230441|NCT02405780|OG004|Outcome|FKB327 Period II|From Week 30 all patients were treated with FKB327
11230442|NCT02405780|OG000|Outcome|FKB327-FKB327-FKB327|"Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study, FKB327-002 and were re-randomized to FKB327 in Period I of study FKB327-003 (F-F).~Period II: From week 30 all subjects received FKB327 (F-F-F)."
11230443|NCT02405780|OG001|Outcome|FKB327-Humira-FKB327|"Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study FKB327-002 and were re-randomized to the reference product, Humira, during Period I of study FKB327-003 (F-H).~Period II: From week 30 all subjects received FKB327 (F-H-F)."
11230444|NCT02405780|OG002|Outcome|Humira-FKB327-FKB327|"Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002 and were re-randomized to FKB327 during Period I of study FKB327-003 (H-F).~Period II: From week 30 all subjects received FKB327 (H-F-F)."
11230445|NCT02405780|OG003|Outcome|Humira-Humira-FKB327|"Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002, and were re-randomized to the reference product Humira during Period I of study FKB327-003 (H-H).~Period II: From week 30 all subjects received FKB327 (H-H-F)."
11230446|NCT02405780|OG001|Outcome|FKB327-Humira-FKB327|"Period I: This is the treatment arm where subjects had been treated with FKB327 in the preceding study FKB327-002 and were re-randomized to the reference product Humira during Period I of study FKB327-003 (F-H).~Period II: From week 30 all subjects received FKB327 (F-H-F)."
11230447|NCT02405780|OG003|Outcome|Humira-Humira-FKB327|"Period I: This is the treatment arm where subjects had been treated with the reference product Humira in the preceding study, FKB327-002, and were re-randomized to the reference product Humira during Period I of study FKB327-003 (H-H).~Period I: From week 30 all subjects received FKB327 (H-H-F)."
11230448|NCT02405780|EG000|Reported Event|FKB327|FKB327: Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg/0.8mL every 2 weeks for 28 weeks. From week 30 all patients were transferred to receive FKB327 40 mg/0.8 mL every other week presented in an auto-injector (AI) or a pre-filled syringe (PFS). Some patients received continuous FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.
11230449|NCT02405780|EG001|Reported Event|Humira®|Humira®: Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. From week 30 to week 76 all patients were transferred to receive FKB327 40 mg/0.8 mL in a pre-filled syringe (PFS) every other week by subcutaneous injection.
11230450|NCT02405962|BG000|Baseline|Control Group|"Parents of children with asthma will receive one session of asthma educational talk as the usual care, plus three weekly sessions of telephone calls to assess the child's asthma symptoms~Control: One session of educational talk about pediatric asthma care, as the usual care.~To ensure the equivalency of the assigned sessions between groups, after attending the talk in the first week, the parents in the Control group will receive three telephone calls, starting from the second week on a weekly basis. This arrangement can also minimize the interference of the usual care naturalistically available in the study setting."
11230451|NCT02405962|BG001|Baseline|ACT Group|"Parents of children with asthma will receive four sessions of group-based ACT intervention integrated with asthma education (its content will be the same as that of the Control Group).~ACT: Four sessions of group-based ACT integrated with asthma education. Each session will compose of pediatric asthma education based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2011, plus group-based Acceptance and Commitment Therapy (ACT). The goal of ACT is to enhance the psychological flexibility of the parents, enabling them to (1) become aware of their thoughts and feelings regarding their child's asthma and its management, (2) accept and adapt flexibly to challenging situations, and (3) take actions to achieve valued goals in childhood asthma management."
11230452|NCT02405962|BG002|Baseline|Total|Total of all reporting groups
11230453|NCT02405962|FG000|Participant Flow|Control Group|"Parents of children with asthma will receive one session of asthma educational talk as the usual care, plus three weekly sessions of telephone calls to assess the child's asthma symptoms~Control: One session of educational talk about pediatric asthma care, as the usual care.~To ensure the equivalency of the assigned sessions between groups, after attending the talk in the first week, the parents in the Control group will receive three telephone calls, starting from the second week on a weekly basis. This arrangement can also minimize the interference of the usual care naturalistically available in the study setting."
11233935|NCT02431572|BG000|Baseline|Metastatic Melanoma to the Brain (Cohort A)|"Assess Inflammation (PBR PET)~Immunotherapy~Assess Inflammation (PBR PET)~PBR PET~Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms."
10887892|NCT00503698|EG001|Reported Event|Placebo|Placebo once daily, week 0 to end of trial
10887893|NCT00503750|BG000|Baseline|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
11230454|NCT02405962|FG001|Participant Flow|ACT Group|"Parents of children with asthma will receive four sessions of group-based ACT intervention integrated with asthma education (its content will be the same as that of the Control Group).~ACT: Four sessions of group-based ACT integrated with asthma education. Each session will compose of pediatric asthma education based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2011, plus group-based Acceptance and Commitment Therapy (ACT). The goal of ACT is to enhance the psychological flexibility of the parents, enabling them to (1) become aware of their thoughts and feelings regarding their child's asthma and its management, (2) accept and adapt flexibly to challenging situations, and (3) take actions to achieve valued goals in childhood asthma management."
11230455|NCT02405962|OG000|Outcome|Control Group|"Parents of children with asthma will receive one session of asthma educational talk as the usual care, plus three weekly sessions of telephone calls to assess the child's asthma symptoms~Control: One session of educational talk about pediatric asthma care, as the usual care.~To ensure the equivalency of the assigned sessions between groups, after attending the talk in the first week, the parents in the Control group will receive three telephone calls, starting from the second week on a weekly basis. This arrangement can also minimize the interference of the usual care naturalistically available in the study setting."
11230456|NCT02405962|OG001|Outcome|ACT Group|"Parents of children with asthma will receive four sessions of group-based ACT intervention integrated with asthma education (its content will be the same as that of the Control Group).~ACT: Four sessions of group-based ACT integrated with asthma education. Each session will compose of pediatric asthma education based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2011, plus group-based Acceptance and Commitment Therapy (ACT). The goal of ACT is to enhance the psychological flexibility of the parents, enabling them to (1) become aware of their thoughts and feelings regarding their child's asthma and its management, (2) accept and adapt flexibly to challenging situations, and (3) take actions to achieve valued goals in childhood asthma management."
11230457|NCT02405962|EG000|Reported Event|Control Group|Participants will receive one session of educational talk on childhood asthma management (Intervention as usual).
11230458|NCT02405962|EG001|Reported Event|ACT Group|Participants will receive four sessions of group-based Acceptance and Commitment Therapy integrated with the asthma education that provided to the participants of the control group.
11230459|NCT02406248|BG000|Baseline|Single Arm|Ticagrelor 90mg twice daily (bd)
11230460|NCT02406248|FG000|Participant Flow|Single Arm|Ticagrelor 90mg twice daily (bd)
11230461|NCT02406248|OG000|Outcome|Single Arm|Ticagrelor 90mg twice daily (bd)
11230462|NCT02406248|EG000|Reported Event|Single Arm|Ticagrelor 90mg twice daily (bd)
11230463|NCT02406261|BG000|Baseline|Cohort A|500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35; 20 mg simvastatin, single oral dose on Days 2 and 36; 250 microgram (mcg) midazolam, intravenous (IV) on Days 3 and 37; 50 mg LY3314814, single oral dose on Day 4; 50 mg LY3314814, single oral dose, Days 10 to 37
11230464|NCT02406261|BG001|Baseline|Cohort B|5 mg donepezil, single oral dose on Day 1 Period 1; 50 mg LY3314814, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28 Period 2
11230465|NCT02406261|BG002|Baseline|Total|Total of all reporting groups
11230466|NCT02406261|FG000|Participant Flow|Cohort A|500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35; 20 mg simvastatin, single oral dose on Days 2 and 36; 250 mcg midazolam, intravenous (IV) on Days 3 and 37; 50 mg LY3314814, single oral dose on Day 4; 50 mg LY3314814, single oral dose, Days 10 to 37
11230467|NCT02406261|FG001|Participant Flow|Cohort B|5 mg donepezil, single oral dose on Day 1 Period 1; 50 mg LY3314814, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28 Period 2
11230468|NCT02406261|OG000|Outcome|Cohort A|500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35; 20 mg simvastatin, single oral dose on Days 2 and 36; 250 microgram (mcg) midazolam, intravenous (IV) on Days 3 and 37; 50 mg LY3314814, single oral dose on Day 4; 50 mg LY3314814, single oral dose, Days 10 to 37
11230469|NCT02406261|OG000|Outcome|Cohort B|5 mg donepezil, single oral dose on Day 1 Period 1; 50 mg LY3314814, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28 Period 2
11230470|NCT02406261|OG001|Outcome|Cohort B|5 mg donepezil, single oral dose on Day 1 Period 1; 50 mg LY3314814, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28 Period 2
11230471|NCT02406261|EG000|Reported Event|Cohort A|500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35; 20 mg simvastatin, single oral dose on Days 2 and 36; 250 microgram (mcg) midazolam, intravenous (IV) on Days 3 and 37; 50 mg LY3314814, single oral dose on Day 4; 50 mg LY3314814, single oral dose, Days 10 to 37
11230472|NCT02406261|EG001|Reported Event|Cohort B|5 mg donepezil, single oral dose on Day 1 Period 1; 50 mg LY3314814, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28 Period 2
11352020|NCT03965039|EG003|Reported Event|Experimental Dipotassium Oxalate Toothpaste|"Brush Twice Daily~Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste"
11352021|NCT03963401|BG000|Baseline|PF-06700841 60 mg QD -> PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
11352022|NCT03963401|BG001|Baseline|PF-06700841 30 mg QD -> PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
11352023|NCT03963401|BG002|Baseline|PF-06700841 10 mg QD -> PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg QD during the extension period (Week 17 through Week 52).
11352024|NCT03963401|BG003|Baseline|PF-06700841 10 mg QD -> PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
11352025|NCT03963401|BG004|Baseline|Placebo -> PF-06700841 60 mg QD|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
11352026|NCT03963401|BG005|Baseline|Placebo -> PF-06700841 30 mg QD|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
11089408|NCT01523756|FG000|Participant Flow|Own Product (Baseline) - Test Product 1 - Test Product 2|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
11352027|NCT03963401|BG006|Baseline|Total|Total of all reporting groups
11352028|NCT03963401|FG000|Participant Flow|PF-06700841 60 mg QD -> PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 60 milligram (mg) once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
11352029|NCT03963401|FG001|Participant Flow|PF-06700841 30 mg QD -> PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
11352030|NCT03963401|FG002|Participant Flow|PF-06700841 10 mg QD -> PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg QD during the extension period (Week 17 through Week 52).
11352031|NCT03963401|FG003|Participant Flow|PF-06700841 10 mg QD -> PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
11352032|NCT03963401|FG004|Participant Flow|Placebo -> PF-06700841 60 mg QD|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
11352033|NCT03963401|FG005|Participant Flow|Placebo -> PF-06700841 30 mg QD|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
11352034|NCT03963401|OG000|Outcome|Placebo|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
11352035|NCT03963401|OG001|Outcome|PF-06700841 10 mg QD|PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
11352036|NCT03963401|OG002|Outcome|PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
11352037|NCT03963401|OG003|Outcome|PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
11352038|NCT03963401|OG000|Outcome|PF-06700841 60 mg QD -> PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
11352039|NCT03963401|OG001|Outcome|PF-06700841 30 mg QD -> PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
11352040|NCT03963401|OG002|Outcome|PF-06700841 10 mg QD -> PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.
11352041|NCT03963401|OG003|Outcome|PF-06700841 10 mg QD -> PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
11089409|NCT01523756|FG001|Participant Flow|Own Product (Baseline) - Test Product 2 - Test Product 1|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
11230473|NCT02406443|BG000|Baseline|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
11230474|NCT02406443|BG001|Baseline|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
11230475|NCT02406443|BG002|Baseline|Total|Total of all reporting groups
11230476|NCT02406443|FG000|Participant Flow|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
11230477|NCT02406443|FG001|Participant Flow|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
11230478|NCT02406443|OG000|Outcome|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
11230479|NCT02406443|OG001|Outcome|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
11230480|NCT02406443|EG000|Reported Event|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
11230481|NCT02406443|EG001|Reported Event|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
11230482|NCT02406495|BG000|Baseline|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230483|NCT02406495|FG000|Participant Flow|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230484|NCT02406495|OG000|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230485|NCT02406495|OG001|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230486|NCT02406495|OG000|Outcome|Filcon IV 1 OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230487|NCT02406495|OG001|Outcome|Filcon IV 1 OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230488|NCT02406495|OG002|Outcome|Ocufilcon D OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230489|NCT02406495|OG003|Outcome|Ocufilcon D OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230490|NCT02406495|OG000|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230491|NCT02406495|OG001|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230492|NCT02406495|OG002|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230493|NCT02406495|OG003|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230494|NCT02406495|EG000|Reported Event|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
11230495|NCT02406573|BG000|Baseline|Crest® Sensi-Stop™ Strips|"Professionally Applied~Crest® Sensi-Stop™ Strips"
11230496|NCT02406573|FG000|Participant Flow|Crest® Sensi-Stop™ Strips|"Professionally Applied~Crest® Sensi-Stop™ Strips"
11230497|NCT02406573|OG000|Outcome|Crest® Sensi-Stop™ Strips|"Professionally Applied~Crest® Sensi-Stop™ Strips"
11230498|NCT02406573|EG000|Reported Event|Crest® Sensi-Stop™ Strips|"Professionally Applied~Crest® Sensi-Stop™ Strips"
11230499|NCT02406586|BG000|Baseline|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230500|NCT02406586|BG001|Baseline|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
11167241|NCT01977781|EG001|Reported Event|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
11167242|NCT01977794|BG000|Baseline|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
11167243|NCT01977794|BG001|Baseline|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
11167244|NCT01977794|BG002|Baseline|Total|Total of all reporting groups
11167245|NCT01977794|FG000|Participant Flow|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 milligram (mg) before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine fixed dose combination(FDC) tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at initial dose of 5mg/5mg once daily for 6 weeks.If blood pressure (BP) was controlled at Week 6(Day 43),same dose continued for next 6 weeks. If BP was not controlled at Day 43,dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks.Subjects who had controlled BP atWeek 12(Day 85),continued same dose that they were receiving for next 6 weeks. If BP was not controlled at Day 85,dose was increased to next level,(Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18(Day 127).Controlled BP=Systolic BP(SBP)<140 millimetre of mercury(mmHg) and Diastolic BP(DBP)<90mmHg.
11167246|NCT01977794|FG001|Participant Flow|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP = SBP <140 mmHg and DBP <90 mmHg.
11167247|NCT01977794|OG000|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
11167248|NCT01977794|OG001|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
11230501|NCT02406586|BG002|Baseline|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230502|NCT02406586|BG003|Baseline|Total|Total of all reporting groups
11167249|NCT01977794|EG000|Reported Event|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
11167250|NCT01977794|EG001|Reported Event|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
11167251|NCT01977820|BG000|Baseline|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
11167252|NCT01977820|BG001|Baseline|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
11167253|NCT01977820|BG002|Baseline|Total|Total of all reporting groups
11167254|NCT01977820|FG000|Participant Flow|Sapropterin|Subject was administered with 20 milligram per kilogram (mg/kg) sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
11167255|NCT01977820|FG001|Participant Flow|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
11167256|NCT01977820|OG000|Outcome|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
11167257|NCT01977820|OG001|Outcome|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
11167258|NCT01977820|EG000|Reported Event|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
11167259|NCT01977820|EG001|Reported Event|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
11167260|NCT01977846|BG000|Baseline|Retrospective Cohort|Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants were to have at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT))
11167261|NCT01977846|BG001|Baseline|Prospective Cohort|Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants were to have standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry.
11167262|NCT01977846|BG002|Baseline|Total|Total of all reporting groups
11167263|NCT01977846|FG000|Participant Flow|Retrospective Cohort|Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participant's data are from clinical examinations and central reading center (RC) grading of retinal imaging (fundus auto-fluorescence, and spectral domain optical coherence tomography (OCT).
11230503|NCT02406586|FG000|Participant Flow|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230504|NCT02406586|FG001|Participant Flow|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230505|NCT02406586|FG002|Participant Flow|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230506|NCT02406586|OG000|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230507|NCT02406586|OG001|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230508|NCT02406586|OG002|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230509|NCT02406586|OG000|Outcome|Salsalate|"Obese, normotensive, healthy subjects will receive an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject has no side effects, the dose will be increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects will then receive another 24-hour IV administration of Intralipid 20% at the 6-week point.~Salsalate: Salsalate 750 mg~Intralipid 20%: 24-hour infusion of Intralipid 20% solution at 20 mL/h (96 g/24 h)"
11230510|NCT02406586|OG001|Outcome|Carvedilol|"Obese, normotensive, healthy subjects will receive an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject has no side effects, the dose will be increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects will then receive another 24-hour IV administration of Intralipid 20% at the 6-week point.~Carvedilol: Carvedilol 3.125 mg~Intralipid 20%: 24-hour infusion of Intralipid 20% solution at 20 mL/h (96 g/24 h)"
11230511|NCT02406586|OG002|Outcome|Placebo|"Obese, normotensive, healthy subjects will receive an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose will be increased to two placebo tablets twice daily for the remaining four weeks. The subjects will then receive another 24-hour IV administration of Intralipid 20% at the 6-week point.~Placebo: One tablet~Intralipid 20%: 24-hour infusion of Intralipid 20% solution at 20 mL/h (96 g/24 h)"
11230512|NCT02406586|EG000|Reported Event|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230513|NCT02406586|EG001|Reported Event|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230514|NCT02406586|EG002|Reported Event|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
11230515|NCT02406612|BG000|Baseline|Diagnostic|Patients treated with X-Seal device that were undergoing a diagnostic catheter procedure.
11230516|NCT02406612|BG001|Baseline|Interventional|Patients treated with X-Seal device that underwent an interventional catheter procedure.
11230517|NCT02406612|BG002|Baseline|Total|Total of all reporting groups
11230518|NCT02406612|FG000|Participant Flow|Diagnostic|Patients treated with X-Seal device that were undergoing a diagnostic catheter procedure.
11230519|NCT02406612|FG001|Participant Flow|Interventional|Patients treated with X-Seal device that underwent an interventional catheter procedure.
11230520|NCT02406612|OG000|Outcome|Diagnostic|Patients treated with X-Seal device that were underwent a diagnostic catheter procedure.
11230521|NCT02406612|OG001|Outcome|Interventional|Patients treated with X-Seal device that underwent an interventional catheter procedure.
11230522|NCT02406612|EG000|Reported Event|Diagnostic|Patients treated with X-Seal device that underwent a diagnostic catheter procedure.
11230523|NCT02406612|EG001|Reported Event|Interventional|Patients treated with X-Seal device that underwent an interventional catheter procedure.
11233936|NCT02431572|BG001|Baseline|Primary Brain Tumor (Cohort B)|"Assess Inflammation (PBR PET)~Immunotherapy~Assess Inflammation (PBR PET)~PBR PET~Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms."
11230524|NCT02406651|BG000|Baseline|F-652 and Systemic Coritcosteroids|"Subjects will be dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing will be concurrent with systemic corticosteroids.~Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.~Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) will be given at a dose of 2 mg/kg/day and tapered as needed."
11230525|NCT02406651|FG000|Participant Flow|F-652 and Systemic Coritcosteroids|"Subjects was dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing was concurrent with systemic corticosteroids.~Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.~Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) was given at a dose of 2 mg/kg/day and tapered as needed."
11230526|NCT02406651|OG000|Outcome|F-652 and Systemic Coritcosteroids|"Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing were concurrent with systemic corticosteroids.~Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.~Systemic Corticosteroids: Prednisone (or equivalent) was at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed."
11230527|NCT02406651|OG000|Outcome|F-652 and Systemic Coritcosteroids|"Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing were concurrent with systemic corticosteroids.~Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.~Systemic Corticosteroids: Prednisone (or equivalent) was given at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed."
11230528|NCT02406651|EG000|Reported Event|F-652 and Systemic Coritcosteroids|"Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing will be concurrent with systemic corticosteroids.~Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652.~Systemic Corticosteroids: Prednisone (or equivalent) was given at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed."
11230529|NCT02406677|BG000|Baseline|Copayment Intervention Arm|Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.
11230530|NCT02406677|BG001|Baseline|Usual Care Arm|For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
11230531|NCT02406677|BG002|Baseline|Total|Total of all reporting groups
11230532|NCT02406677|FG000|Participant Flow|Copayment Intervention Arm|Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.
11230533|NCT02406677|FG001|Participant Flow|Usual Care Arm|For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
11230534|NCT02406677|OG000|Outcome|Copayment Intervention Arm|Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.
11230535|NCT02406677|OG001|Outcome|Usual Care Arm|For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
11230536|NCT02406677|OG000|Outcome|Copayment Intervention Arm - Clopidogrel|Patients in the intervention arm discharged on Clopidogrel
11230537|NCT02406677|OG001|Outcome|Copayment Intervention Arm - Ticagrelor|Patients in the intervention arm discharged on Ticagrelor
11230538|NCT02406677|OG002|Outcome|Usual Care Arm - Clopidogrel|Patients in the Usual Care Arm discharged on Clopidogrel
11230539|NCT02406677|OG003|Outcome|Usual Care Arm - Ticagrelor|Patients in the Usual Care Arm discharged on Ticagrelor
11230540|NCT02406677|EG000|Reported Event|Copayment Intervention Arm|Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.
11230541|NCT02406677|EG001|Reported Event|Usual Care Arm|For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
11230542|NCT02406742|BG000|Baseline|Arm A|CC-122 single agent Dose Escalation
11230543|NCT02406742|BG001|Baseline|Arm B|CC-122 in combination with ibrutinib Dose Escalation
11230544|NCT02406742|BG002|Baseline|Arm C|CC-122 in combination with obinutuzumab Dose Escalation
11230545|NCT02406742|BG003|Baseline|Total|Total of all reporting groups
11230546|NCT02406742|FG000|Participant Flow|Arm A|CC-122 single agent Dose Escalation
11230547|NCT02406742|FG001|Participant Flow|Arm B|CC-122 in combination with ibrutinib Dose Escalation
11230548|NCT02406742|FG002|Participant Flow|Arm C|CC-122 in combination with obinutuzumab Dose Escalation
11230549|NCT02406742|OG000|Outcome|Arm A|CC-122 single agent Dose Escalation
11230550|NCT02406742|OG001|Outcome|Arm B|CC-122 in combination with ibrutinib Dose Escalation
11230551|NCT02406742|OG002|Outcome|Arm C|CC-122 in combination with obinutuzumab Dose Escalation
11230552|NCT02406742|EG000|Reported Event|A (CC-122)|CC-122 single agent
11230553|NCT02406742|EG001|Reported Event|B (CC-122+Ibrutinib)|CC-122 in combination with ibrutinib
11230554|NCT02406742|EG002|Reported Event|C (CC-122+Obinutuzumab)|CC-122 in combination with obinutuzumab
11230555|NCT02406859|BG000|Baseline|Able Bodied Participants|The representation of this group are those participants with no known spinal cord injury and full motor function.
11230556|NCT02406859|BG001|Baseline|Complete Spinal Cord Injury (ASIA A)|The representation of this group are those participants with known spinal cord injury and medically diagnosed with an American spinal cord injury rating of A. This exam will delineate that the individual has a complete lack of motor and sensory function below the level of injury.
11352042|NCT03963401|OG004|Outcome|Placebo -> PF-06700841 60 mg QD|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
11352043|NCT03963401|OG005|Outcome|Placebo -> PF-06700841 30 mg QD|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
11352044|NCT03963401|EG000|Reported Event|PF-06700841 60 mg QD -> PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
11352045|NCT03963401|EG001|Reported Event|PF-06700841 30 mg QD -> PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
11352046|NCT03963401|EG002|Reported Event|PF-06700841 10 mg QD -> PF-06700841 60 mg QD|PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.
11352047|NCT03963401|EG003|Reported Event|PF-06700841 10 mg QD -> PF-06700841 30 mg QD|PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
11352048|NCT03963401|EG004|Reported Event|Placebo -> PF-06700841 60 mg QD|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
11352049|NCT03963401|EG005|Reported Event|Placebo -> PF-06700841 30 mg QD|Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
11352050|NCT03962634|BG000|Baseline|Kovanaze Nasal Spray (Pediatrics)|"Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth~Kovanaze Nasal Spray: Intra-nasal local anesthetic"
11352051|NCT03962634|BG001|Baseline|Articaine Injections (Pediatrics)|"Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth~Articaine Injection: Local anesthetic"
10914693|NCT00632489|BG002|Baseline|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
10914694|NCT00632489|BG003|Baseline|Total|Total of all reporting groups
11352052|NCT03962634|BG002|Baseline|Total|Total of all reporting groups
11352053|NCT03962634|FG000|Participant Flow|Kovanaze Nasal Spray (Pediatrics)|"Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth~Kovanaze Nasal Spray: Intra-nasal local anesthetic"
11352054|NCT03962634|FG001|Participant Flow|Articaine Injections (Pediatrics)|"Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth~Articaine Injection: Local anesthetic"
11352055|NCT03962634|OG000|Outcome|Kovanaze Nasal Spray (Pediatrics)|"Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth~Kovanaze Nasal Spray: Intra-nasal local anesthetic"
11352056|NCT03962634|OG001|Outcome|Articaine Injections (Pediatrics)|"Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth~Articaine Injection: Local anesthetic"
11352057|NCT03962634|EG000|Reported Event|Kovanaze Nasal Spray (Pediatrics)|"Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth~Kovanaze Nasal Spray: Intra-nasal local anesthetic"
11352058|NCT03962634|EG001|Reported Event|Articaine Injections (Pediatrics)|"Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth~Articaine Injection: Local anesthetic"
11352059|NCT03962790|BG000|Baseline|Overall Set|All subjects dispensed a study lens.
11352060|NCT03962790|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test lens during the first period and then received the control lens during the second period.
11352061|NCT03962790|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.
11352062|NCT03962790|OG000|Outcome|Etafilcon A Test for Novel|Subjects who wore the Test lens made with a novel manufacturing technology in either the first or second period of the study.
11352063|NCT03962790|OG001|Outcome|Etafilcon A Control for Current|Subjects that wore the Control lens made with the current manufacturing technology in either the first or second period of the study.
11352064|NCT03962790|EG000|Reported Event|Etafilcon A Test for Novel|Subjects who wore the Test lens made with a novel manufacturing technology in either the first or second period of the study.
11352065|NCT03962790|EG001|Reported Event|Etafilcon A Control for Current|Subjects that wore the Control lens made with the current manufacturing technology in either the first or second period of the study.
11352066|NCT03956225|BG000|Baseline|iLux|Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.
11352067|NCT03956225|BG001|Baseline|LipiFlow|Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.
11352068|NCT03956225|BG002|Baseline|Total|Total of all reporting groups
11352069|NCT03956225|FG000|Participant Flow|iLux|Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.
10914695|NCT00632489|FG000|Participant Flow|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
11089410|NCT01523756|OG000|Outcome|Test Product 1|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
11089411|NCT01523756|OG001|Outcome|Test Product 2|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
11089412|NCT01523756|OG002|Outcome|Baseline|"Data collected on own product-~All subjects collected baseline data on own product in the first period."
11089413|NCT01523756|EG000|Reported Event|Test Product 1|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
11089414|NCT01523756|EG001|Reported Event|Test Product 2|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
11089415|NCT01523756|EG002|Reported Event|Baseline|"Data collected on own product-~All subjects collected baseline data on own product in the first period."
11089416|NCT01523782|BG000|Baseline|GRASPA 50 IU/kg|"Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase.~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11089417|NCT01523782|BG001|Baseline|GRASPA 100 IU/kg|"Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11089418|NCT01523782|BG002|Baseline|GRASPA 150 IU/kg|"Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11089419|NCT01523782|BG003|Baseline|Total|Total of all reporting groups
11089420|NCT01523782|FG000|Participant Flow|GRASPA 50 IU/kg|"Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase.~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11089421|NCT01523782|FG001|Participant Flow|GRASPA 100 IU/kg|"Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11089422|NCT01523782|FG002|Participant Flow|GRASPA 150 IU/kg|"Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11089423|NCT01523782|OG000|Outcome|GRASPA 50 IU/kg|"Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase.~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11089424|NCT01523782|OG001|Outcome|GRASPA 100 IU/kg|"Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11089425|NCT01523782|OG002|Outcome|GRASPA 150 IU/kg|"Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11230557|NCT02406859|BG002|Baseline|Incomplete Spinal Cord Injury (ASIA B, C, D)|The representation of this group are those participants with known spinal cord injury and medically diagnosed with an American spinal cord injury rating of B,C or D. This exam will delineate that the individual falls within the range of having some sensation below the level of injury to most motor function and sensation being preserved below the level of injury.
11230558|NCT02406859|BG003|Baseline|Total|Total of all reporting groups
11230559|NCT02406859|FG000|Participant Flow|Able Body Participants|Anorectal Manometry: Able bodied subjects will undergo anorectal manometry and a baseline assessment of level of constipation or frequency of fecal incontinence (FI). Subjects will undergo an anorectal manometry to establish baseline pressure characteristics.
11230560|NCT02406859|FG001|Participant Flow|Complete Spinal Cord Injury (ASIA A)|Anorectal Manometry: Subjects with ASIA A spinal cord injury will undergo anorectal manometry and a baseline assessment of level of constipation or frequency of fecal incontinence (FI). The 10 Question Bowel Survey and Incontinence Scale will be administered. Subjects will undergo an anorectal manometry to establish baseline pressure characteristics.
11230561|NCT02406859|FG002|Participant Flow|Incomplete Spinal Cord Injury (ASIA B,C,D)|"Part 1 Anorectal Manometry and 10 Question Bowel Survey~Part 2 [Bowel Biofeedback]: A subgroup of subjects who participated in the first arm of the study (Anorectal Motility) and report either constipation or fecal incontinence will be asked to participate in 12 weeks of twice weekly, biofeedback training. The biofeedback training will consist of in-lab exercises that are paired with a visual feedback. Anorectal manometry and bowel surveys will be repeated after the training session to assess the effects of bowel biofeedback on anorectal function.~Bowel Biofeedback: Subjects will complete 2 sessions twice a week for 6 weeks of bowel biofeedback training. Subjects will be asked to squeeze and bear down for a period of 5 seconds followed by rest for 10seconds. Following the training, each subject will complete similar training at home for 6 weeks."
11230562|NCT02406859|OG000|Outcome|Able Bodied Participants|Part 1 [Anorectal Manometry]: Able bodied subjects will undergo an anorectal manometry to establish baseline pressure characteristics to serve as a comparison group for the SCI complete and incomplete baseline groups.
11230563|NCT02406859|OG001|Outcome|Complete Spinal Cord Injury (ASIA A)|Part 1 [Anorectal Manometry]: Subjects with complete spinal cord injury will undergo an anorectal manometry to establish baseline pressure characteristics, to compare with the incomplete spinal cord injury group.
11230564|NCT02406859|OG002|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D)|Part 1 [Anorectal Manometry]: Subjects with incomplete spinal cord injury will undergo an anorectal manometry to establish baseline pressure characteristics. If subjects qualify for biofeedback training, they will complete two additional manometries to track the changes occurring due to training.
11230565|NCT02406859|OG000|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Baseline (Pre-bowel Biofeedback Training)|Baseline characteristics were assessed. Squeezing and bearing down maneuvers were attempted.
11230566|NCT02406859|OG001|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 1 (Guided)|Bowel Biofeedback Training (Guided): Subjects will complete 2 sessions twice a week for 6 weeks of bowel biofeedback training. Subjects will be asked to squeeze and bear down for a period of 5 seconds followed by rest for 10 seconds.
11230567|NCT02406859|OG002|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 2 (Self Guided)|Bowel Biofeedback Training (Self Guided): Subjects will complete an at home training program 2 times a week over a 6 week period.
11230568|NCT02406859|OG000|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Baseline (Pre-bowel Biofeedback Training)|Subjects with incomplete spinal cord injury were asked to complete a balloon distension test pre-biofeedback training (baseline). The rectal balloon was distended until an urge to defecate occurs or to a maximum of 150 CCs.
11230569|NCT02406859|OG001|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 1 (Guided)|Bowel Biofeedback Training (Guided): Subjects with Incomplete SCI were asked to perform a balloon distention test following six week of guided bowel biofeedback training.
11230570|NCT02406859|OG002|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 2 (Self Guided)|Bowel Biofeedback Training (Self Guided): Subjects with Incomplete SCI were asked to perform a balloon distention test following 6 weeks of self-guided bowel biofeedback training.
11230571|NCT02406859|OG000|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Baseline (Pre-bowel Biofeedback Training)|Baseline - subjects with incomplete Spinal Cord Injury (ASIA B, C, D) were asked to complete the 10 Question Bowel Survey (QBS) prior to biofeedback training.
11230572|NCT02406859|OG001|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 1 (Guided)|Bowel Biofeedback Training (Guided): Subjects with incomplete Spinal Cord Injury (ASIA B, C, D) were asked to complete the 10 QBS following 2 sessions twice a week for 6 weeks of bowel biofeedback training.
11230573|NCT02406859|OG002|Outcome|Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 2 (Self Guided)|Bowel Biofeedback Training (Self Guided): Subjects with incomplete Spinal Cord Injury (ASIA B, C, D) were asked to complete the 10 QBS following an at home training program 2 times a week over a 6 week period..
11230574|NCT02406859|EG000|Reported Event|Able Body Participants|Anorectal Manometry: Able bodied subjects underwent anorectal manometry as a baseline assessment. Anorectal manometry is the only procedure that put this group an greater than no risk.
11230575|NCT02406859|EG001|Reported Event|Complete Spinal Cord Injury (ASIA A)|Anorectal Manometry: SCI subjects medical designated with an injury severity score of ASIA A underwent anorectal manometry as a baseline assessment. Anorectal manometry is the only procedure that put this group an greater than no risk.
11230576|NCT02406859|EG002|Reported Event|Incomplete Spinal Cord Injury (ASIA B,C,D)|Anorectal Manometry: SCI subjects medical designated with an injury severity score of ASIA B,C and D underwent anorectal manometry as a baseline assessment. Participants were then asked to participate in 12 weeks of twice weekly, biofeedback training. The biofeedback training will consist of in-lab exercises that are paired with a visual feedback. Anorectal manometry was repeated after the training session to assess the effects of bowel biofeedback on anorectal function.
11233937|NCT02431572|BG002|Baseline|Primary Brain Tumor (Cohort C)|"Chemoradiation~Assess inflammation (PBR PET)~Follow Patients~PBR PET~Radiation and chemotherapy: Subjects with glioblastoma will receive or will have received treatment with chemotherapy and radiation per the standard of care."
11230577|NCT02406885|BG000|Baseline|APB Study: Apixaban Pharmacokinetics in VSG|"To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy~Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery."
11230578|NCT02406885|BG001|Baseline|APB Study: Apixaban Pharmacokinetics in RYGB|"To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.~Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery."
11230579|NCT02406885|BG002|Baseline|Total|Total of all reporting groups
11230580|NCT02406885|FG000|Participant Flow|APB Study: Apixaban Pharmacokinetics in RYGB|"To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass (RYGB).~Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery."
11230581|NCT02406885|FG001|Participant Flow|APB Study: Apixaban Pharmacokinetics in VSG|"To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy (VSG).~Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery."
11230582|NCT02406885|OG000|Outcome|APB Study: Apixaban Pharmacokinetics in VSG|"To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy~Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery."
11230583|NCT02406885|OG001|Outcome|APB Study: Apixaban Pharmacokinetics in RYGB|"To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.~Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery."
11230584|NCT02406885|EG000|Reported Event|APB Study: Apixaban Pharmacokinetics in RYGB|"To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.~Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery."
11230585|NCT02406885|EG001|Reported Event|APB Study: Apixaban Pharmacokinetics in VSG|"To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy.~Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery."
11233938|NCT02431572|BG003|Baseline|Total|Total of all reporting groups
11233939|NCT02431572|FG000|Participant Flow|Metastatic Melanoma to the Brain (Cohort A)|"Assess Inflammation (PBR PET)~Immunotherapy~Assess Inflammation (PBR PET)~PBR PET~Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms."
11233940|NCT02431572|FG001|Participant Flow|Primary Brain Tumor (Cohort B)|"Assess Inflammation (PBR PET)~Immunotherapy~Assess Inflammation (PBR PET)~PBR PET~Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms."
11233941|NCT02431572|FG002|Participant Flow|Primary Brain Tumor (Cohort C)|"Chemoradiation~Assess inflammation (PBR PET)~Follow Patients~PBR PET~Radiation and chemotherapy: Subjects with glioblastoma will receive or will have received treatment with chemotherapy and radiation per the standard of care."
11233942|NCT02431572|OG000|Outcome|Metastatic Melanoma to the Brain (Cohort A)|"Assess Inflammation (PBR PET)~Immunotherapy~Assess Inflammation (PBR PET)~PBR PET~Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms."
11233943|NCT02431572|OG001|Outcome|Primary Brain Tumor (Cohort B)|"Assess Inflammation (PBR PET)~Immunotherapy~Assess Inflammation (PBR PET)~PBR PET~Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms."
11233944|NCT02431572|OG000|Outcome|Primary Brain Tumor (Cohort C)|"Chemoradiation~Assess inflammation (PBR PET)~Follow Patients~PBR PET~Radiation and chemotherapy: Subjects with glioblastoma will receive or will have received treatment with chemotherapy and radiation per the standard of care."
11233945|NCT02431572|EG000|Reported Event|Metastatic Melanoma to the Brain (Cohort A)|"Assess Inflammation (PBR PET)~Immunotherapy~Assess Inflammation (PBR PET)~PBR PET~Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms."
11233946|NCT02431572|EG001|Reported Event|Primary Brain Tumor (Cohort B)|"Assess Inflammation (PBR PET)~Immunotherapy~Assess Inflammation (PBR PET)~PBR PET~Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms."
11233947|NCT02431572|EG002|Reported Event|Primary Brain Tumor (Cohort C)|"Chemoradiation~Assess inflammation (PBR PET)~Follow Patients~PBR PET~Radiation and chemotherapy: Subjects with glioblastoma will receive or will have received treatment with chemotherapy and radiation per the standard of care."
11233948|NCT02431598|BG000|Baseline|Eovistvs vs. Dotarem vs. Saline|
11233949|NCT02431598|FG000|Participant Flow|Eovist Crossover to Dotarem Crossover to Saline|Subjects received the agents in this particular order during their MRI.
11233950|NCT02431598|FG001|Participant Flow|Dotarem Crossover to Eovist Crossover to Saline|Subjects received the agents in this particular order during their MRI.
11352070|NCT03956225|FG001|Participant Flow|LipiFlow|Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.
11352071|NCT03956225|OG000|Outcome|iLux|Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.
11352072|NCT03956225|OG001|Outcome|LipiFlow|Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.
11352073|NCT03956225|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study treatment
11352074|NCT03956225|EG001|Reported Event|iLux Ocular|Events reported in this group occurred in eyes treated with the iLux device
11352075|NCT03956225|EG002|Reported Event|iLux Nonocular|Events reported in this group occurred in subjects treated with the iLux device
11352076|NCT03956225|EG003|Reported Event|LipiFlow Ocular|Events reported in this group occurred in eyes treated with the LipiFlow device
11352077|NCT03956225|EG004|Reported Event|LipiFlow Nonocular|Events reported in this group occurred in subjects treated with the LipiFlow device
11352078|NCT03951610|BG000|Baseline|Overall Study|Total Participants
11089426|NCT01523782|EG000|Reported Event|GRASPA 50 IU/kg|"Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase.~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11352079|NCT03951610|FG000|Participant Flow|Test Lens Then Control Lens|"Subjects were randomized to wear the test lens for one week then the control lens for one week.~Test lens: contact lens"
11352080|NCT03951610|FG001|Participant Flow|Control Lens Then Test Lens|"Subjects were randomized to wear the control lens for one week then the test lens for one week.~Control lens: contact lens"
11352081|NCT03951610|OG000|Outcome|Test Lens|"Subjects were randomized to wear the test lens for one week.~Test lens: contact lens"
11352082|NCT03951610|OG001|Outcome|Control Lens|"Subjects were randomized to wear the control lens for one week.~Control lens: contact lens"
11352083|NCT03951610|EG000|Reported Event|Test Lens|"Subjects were randomized to wear the test lens for one week.~Test lens: contact lens"
11352084|NCT03951610|EG001|Reported Event|Control Lens|"Subjects were randomized to wear the test lens for one week.~Control lens: contact lens"
11352085|NCT03958149|BG000|Baseline|Young Group Aged 18-30 Years|"Participants aged 18-30 years will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.~Spinal collar: cervical collar to immobilise the cervical spine"
11352086|NCT03958149|BG001|Baseline|Older Group Aged 70 Years and Over|"Participants aged 70 years and older will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.~Spinal collar: cervical collar to immobilise the cervical spine"
11352087|NCT03958149|BG002|Baseline|Total|Total of all reporting groups
11352088|NCT03958149|FG000|Participant Flow|Young Group Aged 18-30 Years|"Participants will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.~Spinal collar: cervical collar to immobilise the cervical spine"
11352089|NCT03958149|FG001|Participant Flow|Older Group Aged 70 Years and Over|"Participants will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.~Spinal collar: cervical collar to immobilise the cervical spine"
11352090|NCT03958149|OG000|Outcome|Measurements of Angulation of the Young Group Neck (C-spine)|Baseline angles: Total lordosis angle, Upper cervical lordosis angle, Lower cervical lordosis angle, T1 slope angle, Neck tilt angle, Thoracic inlet angle and the Individual vertebral angles from C1 to T2.
11352091|NCT03958149|OG001|Outcome|Measurements of Angulation of the Older Group Neck (C-spine)|Baseline angles: Total lordosis angle, Upper cervical lordosis angle, Lower cervical lordosis angle, T1 slope angle, Neck tilt angle, Thoracic inlet angle and the Individual vertebral angles from C1 to T2.
11352092|NCT03958149|OG000|Outcome|Change in Degree of Angulation of the Young Group Neck (C-spine)|Change in degree of angle from pre-collar status to post-collar status: Individual vertebral angles from C1 to T2.
11352093|NCT03958149|OG001|Outcome|Change in Degree of Angulation of the Older Group Neck (C-spine)|Change in degree of angle from pre-collar status to post-collar status: Individual vertebral angles from C1 to T2.
11352094|NCT03958149|OG000|Outcome|Young Group Aged 18-30 Years|"Participants aged 18-30 years will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.~Spinal collar: cervical collar to immobilise the cervical spine"
11352095|NCT03958149|OG001|Outcome|Older Group Aged 70 Years and Over|"Participants aged 70 years and over will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.~Spinal collar: cervical collar to immobilise the cervical spine"
11352096|NCT03958149|EG000|Reported Event|Young Group Aged 18-30 Years|"Participants aged 18-30 years will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.~Spinal collar: cervical collar to immobilise the cervical spine"
11352097|NCT03958149|EG001|Reported Event|Older Group Aged 70 Years and Over|"Participants aged 70 years and over will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.~Spinal collar: cervical collar to immobilise the cervical spine"
11352098|NCT03953183|BG000|Baseline|P3P-1mg|"Subjects randomized to exclusive use of P3P-1mg~P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)"
11352099|NCT03953183|BG001|Baseline|P3P-2mg|"Subjects randomized to exclusive use of P3P-2mg~P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)"
11352100|NCT03953183|BG002|Baseline|Total|Total of all reporting groups
11352101|NCT03953183|FG000|Participant Flow|P3P-1mg|"Subjects randomized to exclusive use of P3P-1mg~P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)"
11352102|NCT03953183|FG001|Participant Flow|P3P-2mg|"Subjects randomized to exclusive use of P3P-2mg~P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)"
11230586|NCT02406937|BG000|Baseline|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
11230587|NCT02406937|BG001|Baseline|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
11230588|NCT02406937|BG002|Baseline|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
11230589|NCT02406937|BG003|Baseline|Total|Total of all reporting groups
11230590|NCT02406937|FG000|Participant Flow|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
11230591|NCT02406937|FG001|Participant Flow|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
11230592|NCT02406937|FG002|Participant Flow|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
11230593|NCT02406937|OG000|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
11230594|NCT02406937|OG001|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
11230595|NCT02406937|OG002|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
11230596|NCT02406937|OG000|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake of Feihe New Formula: Oral intake of Feihe New Formula"
11230597|NCT02406937|OG001|Outcome|Feihe Stage 1 Formula|"Oral intake of Feihe stage 1 formula~Oral intake of Feihe Stage 1 Formula: Oral intake of Feihe Stage 1 Formula"
11230598|NCT02406937|OG002|Outcome|Breast Feeding|"Oral intake of breast milk~Breast Feeding: Oral intake of breast milk"
11230599|NCT02406937|EG000|Reported Event|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
11230600|NCT02406937|EG001|Reported Event|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
11230601|NCT02406937|EG002|Reported Event|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
11230602|NCT02407041|BG000|Baseline|GR-MD-02 8 mg/kg|"active arm, 8 mg/kg~GR-MD-02: IV infusion"
11230603|NCT02407041|FG000|Participant Flow|GR-MD-02|"active arm~GR-MD-02: IV infusion"
11230604|NCT02407041|OG000|Outcome|GR-MD-02 8 mg/kg|"active arm, 8 mg/kg~GR-MD-02: IV infusion"
11230605|NCT02407041|EG000|Reported Event|GR-MD-02 8 mg/kg|"active arm, 8 mg/kg~GR-MD-02: IV infusion"
11230606|NCT02407054|BG000|Baseline|Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD|Participants received 200 mg LY3023414 orally every 12 hours (BID) during initial week to assess pharmacokinetics (PK). Thereafter, participants received 200 mg of LY3023414 BID in combination with 160 mg of enzalutamide orally QD beginning Cycle 1 Day 1. A treatment cycle was defined as 28 days.
11230607|NCT02407054|BG001|Baseline|Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD|Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).
11230608|NCT02407054|BG002|Baseline|Part B: Placebo + 160 mg Enzalutamide QD|Participants received placebo in combination with 160 mg enzalutamide orally QD.
11230609|NCT02407054|BG003|Baseline|Total|Total of all reporting groups
11230610|NCT02407054|FG000|Participant Flow|Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD|Participants received 200 milligrams (mg) LY3023414 orally twice daily (BID) during initial week to assess pharmacokinetics (PK). Thereafter, participants received 200 mg of LY3023414 BID in combination with 160 mg of enzalutamide orally QD beginning Cycle 1 Day 1. A treatment cycle was defined as 28 days.
11230611|NCT02407054|FG001|Participant Flow|Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD|Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).
11230612|NCT02407054|FG002|Participant Flow|Part B: Placebo + 160 mg Enzalutamide QD|Participants received placebo in combination with 160 mg enzalutamide orally QD.
11230613|NCT02407054|OG000|Outcome|Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD|Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).
11230614|NCT02407054|OG001|Outcome|Part B: Placebo + 160 mg Enzalutamide QD|Participants received placebo in combination with 160 mg enzalutamide orally QD.
11230615|NCT02407054|OG000|Outcome|Part A: 200 mg LY3023414|Participants received 200 mg LY3023414 orally every 12 hours (BID) during initial week to assess pharmacokinetics (PK).
11230616|NCT02407054|OG001|Outcome|Part A: 200 mg LY3023414 BID + 160 mg Enzalutamide|Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD) at the beginning Cycle 1 Day 1.
11230617|NCT02407054|EG000|Reported Event|Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD|Participants received 200 mg LY3023414 orally every 12 hours (BID) during initial week to assess pharmacokinetics (PK). Thereafter, participants received 200 mg of LY3023414 BID in combination with 160 mg of enzalutamide orally QD beginning Cycle 1 Day 1. A treatment cycle was defined as 28 days.
11230618|NCT02407054|EG001|Reported Event|Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD|Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).
11230619|NCT02407054|EG002|Reported Event|Part B: Placebo + 160 mg Enzalutamide QD|Participants received placebo in combination with 160 mg enzalutamide orally QD.
11230620|NCT02407132|BG000|Baseline|Adapted DSME|Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
11230621|NCT02407132|BG001|Baseline|Standard DSME|Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
11230622|NCT02407132|BG002|Baseline|Total|Total of all reporting groups
11230623|NCT02407132|FG000|Participant Flow|Adapted DSME|Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
11230624|NCT02407132|FG001|Participant Flow|Standard DSME|Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
11230625|NCT02407132|OG000|Outcome|Adapted DSME|Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
11352103|NCT03953183|OG000|Outcome|P3P-1mg|"Subjects randomized to exclusive use of P3P-1mg~P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)"
11352104|NCT03953183|OG001|Outcome|P3P-2mg|"Subjects randomized to exclusive use of P3P-2mg~P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)"
11352105|NCT03953183|EG000|Reported Event|P3P-1mg|"Subjects randomized to exclusive use of P3P-1mg~P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)"
11352106|NCT03953183|EG001|Reported Event|P3P-2mg|"Subjects randomized to exclusive use of P3P-2mg~P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)"
11352107|NCT03949335|BG000|Baseline|ZFR00V|Study Lens
11352108|NCT03949335|BG001|Baseline|ZCB00|Control Lens
11352109|NCT03949335|BG002|Baseline|Total|Total of all reporting groups
11352110|NCT03949335|FG000|Participant Flow|ZFR00V|Study Lens
11352111|NCT03949335|FG001|Participant Flow|ZCB00|Control Lens
11352112|NCT03949335|OG000|Outcome|ZFR00V|Study Lens
11352113|NCT03949335|OG001|Outcome|ZCB00|Control Lens
11352114|NCT03949335|EG000|Reported Event|ZFR00V First Eye|Study Lens
11352115|NCT03949335|EG001|Reported Event|ZCB00 First Eye|Control Lens
11352116|NCT03949335|EG002|Reported Event|ZFR00V Second Eye|Study Lens
11352117|NCT03949335|EG003|Reported Event|ZCB00 Second Eye|Control Lens
11352118|NCT03962738|BG000|Baseline|Placebo|Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
11352119|NCT03962738|BG001|Baseline|50 mg Lasmiditan|50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352120|NCT03962738|BG002|Baseline|100 mg Lasmiditan|100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11089427|NCT01523782|EG001|Reported Event|GRASPA 100 IU/kg|"Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11352121|NCT03962738|BG003|Baseline|200 mg Lasmiditan|200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352122|NCT03962738|BG004|Baseline|Total|Total of all reporting groups
11352123|NCT03962738|FG000|Participant Flow|Placebo|Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once to treat a single migraine attack.
11352124|NCT03962738|FG001|Participant Flow|50 Milligrams (mg) Lasmiditan|50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352125|NCT03962738|FG002|Participant Flow|100 mg Lasmiditan|100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352126|NCT03962738|FG003|Participant Flow|200 mg Lasmiditan|200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352127|NCT03962738|OG000|Outcome|Placebo|Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
11352128|NCT03962738|OG001|Outcome|200 mg Lasmiditan|200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352129|NCT03962738|OG001|Outcome|50 mg Lasmiditan|50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352130|NCT03962738|OG002|Outcome|100 mg Lasmiditan|100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352131|NCT03962738|OG003|Outcome|200 mg Lasmiditan|200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352132|NCT03962738|OG001|Outcome|50 mg Lasmiditan|50 mg Lasmiditan plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352133|NCT03962738|OG001|Outcome|50 mg Lasmiditan|50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack..
11352134|NCT03962738|OG000|Outcome|Placebo|Placebo tablet (plus matching Lasmiditan placebo to maintain the blind) administered orally once to treat a single migraine attack.
11352135|NCT03962738|OG001|Outcome|50 mg Lasmiditan|50 mg Lasmiditan tablet (plus two placebo tablets to maintain the blind) administered orally once to treat a single migraine attack.
11352136|NCT03962738|OG002|Outcome|100 mg Lasmiditan|100 mg Lasmiditan tablet (plus two placebo tablets to maintain the blind) administered orally once to treat a single migraine attack.
11352137|NCT03962738|OG003|Outcome|200 mg Lasmiditan|200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to maintain the blind) administered orally once to treat a single migraine attack.
11352138|NCT03962738|OG002|Outcome|100 mg Lasmiditan|100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack..
11352139|NCT03962738|EG000|Reported Event|Placebo|Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
11352140|NCT03962738|EG001|Reported Event|50 mg Lasmiditan|50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352141|NCT03962738|EG002|Reported Event|100 mg Lasmiditan|100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352142|NCT03962738|EG003|Reported Event|200 mg Lasmiditan|200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
11352143|NCT03962101|BG000|Baseline|OPC-61815 Injection|Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.
11167264|NCT01977846|FG001|Participant Flow|Prospective Cohort|Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participant's data are from standardized clinical examinations and central reading center (RC) grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT) and micro-perimetry (optional).
11167265|NCT01977846|OG000|Outcome|Retrospective Cohort|Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants were to have at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT))
11167266|NCT01977846|OG001|Outcome|Prospective Cohort|Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants were to have standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry.
11167267|NCT01977846|OG000|Outcome|Prospective Cohort|Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). OCT scans were graded by a central reading center.
11167268|NCT01977846|EG000|Reported Event|Retrospective Cohort|Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants should had at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT)). Adverse events were not collected
11167269|NCT01977846|EG001|Reported Event|Prospective Cohort|Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants had standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry. Adverse events were not collected
11167270|NCT01977898|BG000|Baseline|Morphine|"Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.~Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection."
11167271|NCT01977898|BG001|Baseline|Saline|"Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.~Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection."
11167272|NCT01977898|BG002|Baseline|Total|Total of all reporting groups
11167273|NCT01977898|FG000|Participant Flow|Morphine|"Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.~Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection."
11167274|NCT01977898|FG001|Participant Flow|Saline|"Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.~Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection."
11167275|NCT01977898|OG000|Outcome|Morphine|"Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.~Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection."
11230626|NCT02407132|OG001|Outcome|Standard DSME|Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
11230627|NCT02407132|EG000|Reported Event|Standard DSME|Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
11230628|NCT02407132|EG001|Reported Event|Family Model DSME|Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
11230629|NCT02407223|BG000|Baseline|Placebo|Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
11230630|NCT02407223|BG001|Baseline|Ustekinumab 45mg|Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] erythrocyte sedimentation rate [ESR] less than [<] 1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
11230631|NCT02407223|BG002|Baseline|Ustekinumab 90mg|Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
11230632|NCT02407223|BG003|Baseline|Total|Total of all reporting groups
11230633|NCT02407223|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
11230634|NCT02407223|FG001|Participant Flow|Ustekinumab 45mg|Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] erythrocyte sedimentation rate [ESR] less than [<] 1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
11230635|NCT02407223|FG002|Participant Flow|Ustekinumab 90mg|Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
11230636|NCT02407223|OG000|Outcome|Placebo|Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
11230637|NCT02407223|OG001|Outcome|Ustekinumab 45 mg|Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
11230638|NCT02407223|OG002|Outcome|Ustekinumab 90 mg|Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
11230639|NCT02407223|EG000|Reported Event|Placebo Only|Participants received placebo SC at Week 0, 4, 16 and 20. At Week 16, participants in placebo group who qualified for EE criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16, 20 and 28 followed by q12w dosing through Week 52. Participants received placebo SC at Week 24 to maintain the blind. At Week 24, remaining participants in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Week 24 and 28 followed by q12w therapy through Week 52. At Week 52, participants who achieved inactive disease [ASDAS] [ESR]<1.3 at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned Ustekinumab dose at scheduled visits.
11230640|NCT02407223|EG001|Reported Event|Placebo to Ustekinumab 45mg|Participants randomized to placebo SC at Week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 45 mg SC; adverse events are counted from crossover onward. All participants regardless qualified for re-randomization at Week 52 or not were counted.
11230641|NCT02407223|EG002|Reported Event|Placebo to Ustekinumab 90mg|Participants randomized to placebo SC at week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 90 mg SC; adverse events are counted from crossover onward. All participants regardless qualified for re-randomization at Week 52 or not were counted.
11230642|NCT02407223|EG003|Reported Event|Ustekinumab 45mg Only|Participants received ustekinumab 45 mg subcutaneously (SC) at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All participants regardless qualified for re-randomization at Week 52 or not were counted.
11230643|NCT02407223|EG004|Reported Event|Ustekinumab 90mg Only|Participants received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.At Week 52, all participants who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All participants regardless qualified for re-randomization at Week 52 or not were counted.
11230644|NCT02407249|BG000|Baseline|Registry Population|All participants enrolled in the C-FIRM registry.
11230645|NCT02407249|FG000|Participant Flow|Registry Population|All participants enrolled in the C-FIRM registry.
11230646|NCT02407249|OG000|Outcome|Analysis Population|All treated patients
11230647|NCT02407249|EG000|Reported Event|Enrolled Population|All patients enrolled in the registry
11230648|NCT02407457|BG000|Baseline|AFX EVAR AAA Graft System|"Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.~AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access."
11230649|NCT02407457|BG001|Baseline|FDA Approved EVAR AAA Graft Systems|"Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.~FDA Approved EVAR AAA Graft Systems"
11230650|NCT02407457|BG002|Baseline|Total|Total of all reporting groups
11230651|NCT02407457|FG000|Participant Flow|AFX EVAR AAA Graft System|"Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.~AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access."
11230652|NCT02407457|FG001|Participant Flow|FDA Approved EVAR AAA Graft Systems|"Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.~FDA Approved EVAR AAA Graft Systems"
11230653|NCT02407457|OG000|Outcome|AFX EVAR AAA Graft System|"Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.~AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access."
11230654|NCT02407457|OG001|Outcome|FDA Approved EVAR AAA Graft Systems|"Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.~FDA Approved EVAR AAA Graft Systems"
11230655|NCT02407457|EG000|Reported Event|AFX EVAR AAA Graft System|"Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.~AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access."
11230656|NCT02407457|EG001|Reported Event|FDA Approved EVAR AAA Graft Systems|"Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.~FDA Approved EVAR AAA Graft Systems"
11230657|NCT02407704|BG000|Baseline|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230658|NCT02407704|BG001|Baseline|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11233951|NCT02431598|FG002|Participant Flow|Eovist Crossover to Saline Crossover to Dotarem|Subjects received the agents in this particular order during their MRI.
11233952|NCT02431598|FG003|Participant Flow|Saline Crossover to Dotarem Crossover to Eovist|Subjects received the agents in this particular order during their MRI.
11233953|NCT02431598|FG004|Participant Flow|Dotarem Crossover to Saline Crossover to Eovist|Subjects received the agents in this particular order during their MRI.
11233954|NCT02431598|FG005|Participant Flow|Saline Crossover to Eovist Crossover to Dotarem|Subjects received the agents in this particular order during their MRI.
11233955|NCT02431598|OG000|Outcome|Eovist (Gadoxetate Disodium)|
11233956|NCT02431598|OG001|Outcome|Dotarem (Gadoterate Dimeglumine)|
11233957|NCT02431598|OG002|Outcome|Saline|
11233958|NCT02431598|OG000|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
11233959|NCT02431598|OG001|Outcome|Saline|Injection of normal saline
11233960|NCT02431598|OG002|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
11233961|NCT02431598|OG001|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
11233962|NCT02431598|OG002|Outcome|Saline|Injection of normal saline
11233963|NCT02431598|OG000|Outcome|Pre-Contrast Phase|Prior to contrast injection
11233964|NCT02431598|OG001|Outcome|Arterial Phase|Imaging obtained during arterial phase
11233965|NCT02431598|OG002|Outcome|Portal Venous Phase|Imaging obtained during portal venous phase
11233966|NCT02431598|OG003|Outcome|Last Dynamic Phase|Imaging obtained during late dynamic phase
11233967|NCT02431598|EG000|Reported Event|Eovist (Gadoxetate Disodium)|
11233968|NCT02431598|EG001|Reported Event|Dotarem (Gadoterate Dimeglumine)|
11233969|NCT02431598|EG002|Reported Event|Saline|
11335518|NCT03552198|BG003|Baseline|At Risk Group/Alternative Health Advice|"Participants with a self-reported existing health conditions were randomised to receive targeted health advice (based on their health condition) about the adoption of protective behaviours in an alternative format.~Alternative health advice: These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations."
11335519|NCT03552198|BG004|Baseline|Total|Total of all reporting groups
11335520|NCT03552198|FG000|Participant Flow|General Public/Usual Health Advice|Healthy participants with a self-reported existing health condition were randomised to receive the usual UK Air Quality Indices health advice.
11335521|NCT03552198|FG001|Participant Flow|General Public/Alternative Health Advice|"Generally healthy participants were randomised to receive targeted health advice about the adoption of protective behaviours in an alternative format.~Alternative health advice: These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations."
11335522|NCT03552198|FG002|Participant Flow|At Risk Group/Usual Health Advice|Participants with a self-reported pre-existing health condition were randomised to receive the usual UK Air Quality Indices health advice.
11335523|NCT03552198|FG003|Participant Flow|At Risk Group/Alternative Health Advice|"Participants with a self-reported existing health conditions were randomised to receive targeted health advice (based on their health condition) about the adoption of protective behaviours in an alternative format.~Alternative health advice: These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations."
11335524|NCT03552198|OG000|Outcome|General Public/Usual Health Advice|Healthy participants with a self-reported existing health condition were randomised to receive the usual UK Air Quality Indices health advice.
11335525|NCT03552198|OG001|Outcome|General Public/Alternative Health Advice|"Generally healthy participants were randomised to receive targeted health advice about the adoption of protective behaviours in an alternative format.~Alternative health advice: These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations."
11335526|NCT03552198|OG002|Outcome|At Risk Group/Usual Health Advice|Participants with a self-reported pre-existing health condition were randomised to receive the usual UK Air Quality Indices health advice.
11335527|NCT03552198|OG003|Outcome|At Risk Group/Alternative Health Advice|"Participants with a self-reported existing health conditions were randomised to receive targeted health advice (based on their health condition) about the adoption of protective behaviours in an alternative format.~Alternative health advice: These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations."
11335528|NCT03552198|EG000|Reported Event|General Public/Usual Health Advice|Healthy participants with a self-reported existing health condition were randomised to receive the usual UK Air Quality Indices health advice.
11335529|NCT03552198|EG001|Reported Event|General Public/Alternative Health Advice|"Generally healthy participants were randomised to receive targeted health advice about the adoption of protective behaviours in an alternative format.~Alternative health advice: These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations."
11335530|NCT03552198|EG002|Reported Event|At Risk Group/Usual Health Advice|Participants with a self-reported pre-existing health condition were randomised to receive the usual UK Air Quality Indices health advice.
11335531|NCT03552198|EG003|Reported Event|At Risk Group/Alternative Health Advice|"Participants with a self-reported existing health conditions were randomised to receive targeted health advice (based on their health condition) about the adoption of protective behaviours in an alternative format.~Alternative health advice: These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations."
11335532|NCT03552289|BG000|Baseline|Cook Enforcer Balloon Catheter|"The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.~Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula"
11352144|NCT03962101|FG000|Participant Flow|OPC-61815 Injection|Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.
11352145|NCT03962101|OG000|Outcome|OPC-61815 Injection|Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.
11352146|NCT03962101|EG000|Reported Event|OPC-61815 Injection Maintained at 8 mg|Intravenous administration of OPC-61815 at 8 mg once daily for a maximum of 5 days.
11352147|NCT03962101|EG001|Reported Event|OPC-61815 Injection Increased to 16 mg|Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8 mg, increase the dose to 16 mg on Day 2 and onward, according to the dose escalation criteria.
11352148|NCT03959137|BG000|Baseline|Primary Study Group|"A total of 215 patients were enrolled in the study and 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria).~All analyses were performed on the Eligible Population.~Demography data~Age (years)~Gender (male or female)~Weight loss (%)~Smoking status (current, former (defined as smoking ≥ 1 year), never, or unknown)~ECOG status (0, 1, 2, 3-4, or unknown)~Patient's preference for treatment choice (yes, no, or unknown)"
11352149|NCT03959137|FG000|Participant Flow|Primary Study Group - Single Arm|"Stage IV untreated non-small cell lung cancer (NSCLC)~Patient disposition:~Enrolled patients n=215~Eligible patients n=209~Total of 215 patients were enrolled in the study at 21 different sites between 03 June 2019 and 31 October 2019.~Of the enrolled patients, 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria)"
11352150|NCT03959137|OG000|Outcome|Primary Study Group|Confirmed diagnosis of stage IV NSCLC on first-line (1L) systemic treatment
11352151|NCT03959137|EG000|Reported Event|Primary Study Group - Single Arm|"This is a primary data collection non-interventional study being conducted within routine medical practice.~All direction for medication usage is at the discretion of a physician in accordance with usual medical practice.~No administration of any therapeutic or prophylactic agent is required in this protocol, and there are no procedures required as part of this protocol."
11352152|NCT03946124|BG000|Baseline|Fesoterodine|"Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician.~Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder."
10914696|NCT00632489|FG001|Participant Flow|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
11352153|NCT03946124|FG000|Participant Flow|Fesoterodine|"Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician.~Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder."
11352154|NCT03946124|OG000|Outcome|Fesoterodine|"Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician.~Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder."
11352155|NCT03946124|EG000|Reported Event|Fesoterodine|"Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician.~Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder."
11352156|NCT03961308|BG000|Baseline|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352157|NCT03961308|BG001|Baseline|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352158|NCT03961308|BG002|Baseline|Total|Total of all reporting groups
11352159|NCT03961308|FG000|Participant Flow|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352160|NCT03961308|FG001|Participant Flow|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352161|NCT03961308|OG000|Outcome|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352162|NCT03961308|OG001|Outcome|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352163|NCT03961308|EG000|Reported Event|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352164|NCT03961308|EG001|Reported Event|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352165|NCT03961295|BG000|Baseline|Group A: Vedolizumab SC PFS|Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352166|NCT03961295|BG001|Baseline|Group B: Vedolizumab SC Investigational Device|Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352167|NCT03961295|BG002|Baseline|Total|Total of all reporting groups
11352168|NCT03961295|FG000|Participant Flow|Group A: Vedolizumab SC PFS|Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352169|NCT03961295|FG001|Participant Flow|Group B: Vedolizumab SC Investigational Device|Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352170|NCT03961295|OG000|Outcome|Group A: Vedolizumab SC PFS|Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352171|NCT03961295|OG001|Outcome|Group B: Vedolizumab SC Investigational Device|Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352172|NCT03961295|EG000|Reported Event|Group A: Vedolizumab SC PFS|Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352173|NCT03961295|EG001|Reported Event|Group B: Vedolizumab SC Investigational Device|Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352174|NCT03960957|BG000|Baseline|Experimental|"AbobotulinumtoxinA~AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA"
11352175|NCT03960957|BG001|Baseline|Placebo|Placebo: Treatment of glabellar facial lines with placebo
11352176|NCT03960957|BG002|Baseline|Total|Total of all reporting groups
11352177|NCT03960957|FG000|Participant Flow|Experimental|"AbobotulinumtoxinA~AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA"
11352178|NCT03960957|FG001|Participant Flow|Placebo|Placebo: Treatment of glabellar facial lines with placebo
11352179|NCT03960957|OG000|Outcome|Experimental|"AbobotulinumtoxinA~AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA"
11352180|NCT03960957|OG001|Outcome|Placebo|Placebo: Treatment of glabellar facial lines with placebo
11352181|NCT03960957|EG000|Reported Event|Experimental|"AbobotulinumtoxinA~AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA"
11352182|NCT03960957|EG001|Reported Event|Placebo|Placebo: Treatment of glabellar facial lines with placebo
11352183|NCT03956862|BG000|Baseline|Placebo|Placebo QD for 16 weeks
11352184|NCT03956862|BG001|Baseline|GB001|GB001 40 mg QD for 16 weeks
11352185|NCT03956862|BG002|Baseline|Total|Total of all reporting groups
11352186|NCT03956862|FG000|Participant Flow|Placebo|Placebo once per day (QD) for 16 weeks
11352187|NCT03956862|FG001|Participant Flow|GB001|GB001 40 mg QD for 16 weeks
11352188|NCT03956862|OG000|Outcome|Placebo|Placebo QD for 16 weeks
11352189|NCT03956862|OG001|Outcome|GB001|GB001 40 mg QD for 16 weeks
11352190|NCT03956862|EG000|Reported Event|Placebo|Placebo QD for 16 weeks
11352191|NCT03956862|EG001|Reported Event|GB001|GB001 40 mg QD for 16 weeks
11352192|NCT03954444|BG000|Baseline|Oxymetazoline Hydrochloride Cream, 1%|"Oxymetazoline hydrochloride cream, 1%~Oxymetazoline Hydrochloride: Test Comparator"
11352193|NCT03954444|BG001|Baseline|RHOFADE Cream, 1%|"RHOFADE Cream, 1%~Rhofade Cream, 1%: Reference Comparator"
11352194|NCT03954444|BG002|Baseline|Vehicle Cream|"Vehicle cream~Placebo: Placebo Comparator"
11352195|NCT03954444|BG003|Baseline|Total|Total of all reporting groups
11352196|NCT03954444|FG000|Participant Flow|Oxymetazoline Hydrochloride Cream, 1%|"Oxymetazoline hydrochloride cream, 1%~Oxymetazoline Hydrochloride: Test Comparator~Subjects applied once daily to face for 29 days"
11352197|NCT03954444|FG001|Participant Flow|RHOFADE Cream, 1%|"RHOFADE Cream, 1%~Rhofade Cream, 1%: Reference Comparator~Subjects applied once daily to face for 29 days"
11352198|NCT03954444|FG002|Participant Flow|Vehicle Cream|"Vehicle cream~Placebo: Placebo Comparator~Subjects applied once daily to face for 29 days"
11352199|NCT03954444|OG000|Outcome|Oxymetazoline Hydrochloride Cream, 1%|"Oxymetazoline hydrochloride cream, 1%~Oxymetazoline Hydrochloride: Test Comparator"
11352200|NCT03954444|OG001|Outcome|RHOFADE Cream, 1%|"RHOFADE Cream, 1%~Rhofade Cream, 1%: Reference Comparator"
11352201|NCT03954444|OG002|Outcome|Vehicle Cream|"Vehicle cream~Placebo: Placebo Comparator"
11352202|NCT03954444|EG000|Reported Event|Oxymetazoline Hydrochloride Cream, 1%|"Oxymetazoline hydrochloride cream, 1%~Oxymetazoline Hydrochloride: Test Comparator"
11352203|NCT03954444|EG001|Reported Event|RHOFADE Cream, 1%|"RHOFADE Cream, 1%~Rhofade Cream, 1%: Reference Comparator"
11352204|NCT03954444|EG002|Reported Event|Vehicle Cream|"Vehicle cream~Placebo: Placebo Comparator"
11352205|NCT03953820|BG000|Baseline|Overall Population|"31 participants were enrolled and randomized to one of two treatment sequences with a 28-day washout period between doses:~Treatment A was a single dose Diazepam Buccal Film administered on the inner aspect of the cheek according to the recommended dose regimen (10 mg to 17.5 mg according to body weight) following a moderate-fat meal.~Treatment B was Diastat Rectal Gel administered rectally according to the package insert dosing instructions (10 mg to 20 mg according to body weight) following a moderate-fat meal.~Treatment C was a voluntary second dose of Diazepam Buccal Film administered at the same dose and in the same manner as the earlier dose of Diazepam Buccal Film with the exception of administration following a high-fat meal."
11352206|NCT03953820|FG000|Participant Flow|Diazepam Buccal Film, Then Diastat Rectal Gel|"Subjects received a single dose of Diazepam Buccal Film and Diastat Rectal Gel following a moderate-fat meal in a randomized sequence with a 28-day washout period between doses.~Diazepam Buccal Film was administered on the inner aspect of the cheek according to the recommended dose regimen (10 mg to 17.5 mg according to body weight) allowing transbuccal absorption of diazepam."
11352207|NCT03953820|FG001|Participant Flow|Diastat Rectal Gel, Then Diazepam Buccal Film|"Subjects received a single dose of Diastat Rectal Gel and Diazepam Buccal Film following a moderate-fat meal in a randomized sequence with a 28-day washout period between doses.~Diastat Rectal Gel was administered rectally according to package insert dosing instructions (10 mg to 20 mg according to body weight) allowing rectal absorption of diazepam."
11352208|NCT03953820|FG002|Participant Flow|Diazepam Buccal Film Following a High-Fat Meal|"Subjects who completed Periods 1 and 2 were asked to participate in Period 3 on a voluntary basis.~Subjects who volunteered to participate in Period 3 received a second dose of DBF at the same dose and in the same manner as the earlier dose of DBF with the exception was administered following a high-fat meal."
11352209|NCT03953820|OG000|Outcome|DBF Following Moderate-Fat Meal|Subjects received Diazepam Buccal Film administered on the inner aspect of the cheek following ingestion of a moderate-fat meal, allowing for transbuccal absorption of diazepam.
11352210|NCT03953820|OG001|Outcome|DRG Following a Moderate Fat Meal|Subjects received Diastat AcuDial Rectal Gel administered rectally following ingestion of a moderate-fat meal, allowing for rectal absorption of diazepam.
11352211|NCT03953820|OG002|Outcome|DBF Following a High Fat Meal|Subjects received Diazepam Buccal Film administered on the inner aspect of the cheek following ingestion of a high-fat meal, allowing for transbuccal absorption of diazepam.
11352212|NCT03953820|OG000|Outcome|Diazepam Buccal Film Following a Moderate Fat Meal|"Subjects received a single dose of Diazepam Buccal Film and Diastat Rectal Gel following a moderate-fat meal in a randomized sequence with a 28-day washout period between doses.~Diazepam Buccal Film was administered on the inner aspect of the cheek according to the recommended dose regimen (10 mg to 17.5 mg according to body weight) allowing transbuccal absorption of diazepam."
11352213|NCT03953820|OG001|Outcome|Diastat Rectal Gel Following a Moderate Fat Meal|"Subjects received a single dose of Diazepam Buccal Film and Diastat Rectal Gel following a moderate-fat meal in a randomized sequence with a 28-day washout period between doses.~Diastat Rectal Gel was administered rectally according to package insert dosing instructions (10 mg to 20 mg according to body weight) allowing rectal absorption of diazepam."
11352214|NCT03953820|OG002|Outcome|Diazepam Buccal Film Following a High-Fat Meal|Subjects who volunteered to participate in the third period received a second dose of Diazepam Buccal Film in exactly the same manner as the earlier dose with the exception that the dose was administered following ingestion of a high-fat meal.
11352215|NCT03953820|OG000|Outcome|Diazepam Buccal Film Following a Moderate-Fat Meal|"Subjects received a single dose of Diazepam Buccal Film and Diastat Rectal Gel following a moderate-fat meal in a randomized sequence with a 28-day washout period between doses.~Diazepam Buccal Film was administered on the inner aspect of the cheek according to the recommended dose regimen (10 mg to 17.5 mg according to body weight) allowing transbuccal absorption of diazepam."
11352216|NCT03953820|OG001|Outcome|Diastat Rectal Gel Following a Moderate-Fat Meal|"Subjects received a single dose of Diazepam Buccal Film and Diastat Rectal Gel following a moderate-fat meal in a randomized sequence with a 28-day washout period between doses.~Diastat Rectal Gel was administered rectally according to package insert dosing instructions (10 mg to 20 mg according to body weight) allowing rectal absorption of diazepam."
11352217|NCT03953820|EG000|Reported Event|Diazepam Buccal Film Following a Moderate-Fat Meal|"Participants received a single dose of Diazepam Buccal Film and Diastat Rectal Gel following a moderate-fat meal in a randomized sequence with a 28-day washout period between doses.~Diazepam Buccal Film was administered on the inner aspect of the cheek according to the recommended dose regimen (10 mg to 17.5 mg according to body weight) allowing transbuccal absorption of diazepam."
11352218|NCT03953820|EG001|Reported Event|Diastat Rectal Gel Following a Moderate-Fat Meal|"Participants received a single dose of Diazepam Buccal Film and Diastat Rectal Gel following a moderate-fat meal in a randomized sequence with a 28-day washout period between doses.~Diastat Rectal Gel was administered rectally according to package insert dosing instructions (10 mg to 20 mg according to body weight) allowing rectal absorption of diazepam."
11352219|NCT03953820|EG002|Reported Event|Diazepam Buccal Film Following a High-Fat Meal|Participants who volunteered to participate in the third period received a second dose of Diazepam Buccal Film in exactly the same manner as the earlier dose with the exception that the dose was administered following ingestion of a high-fat meal.
11352220|NCT03951766|BG000|Baseline|Smiling Instead of Smoking (SiS) App Version 2|Behavioral: Smiling Instead of Smoking (SiS) App Version 2 The investigators have developed a smartphone app that acts as a behavioral, in-the-pocket coach and uses positive psychology exercises to enhance quitting success. It is anonymous, portable, and provides just-in-time support, an important feature for smokers who smoke under specific conditions and circumstances. To support treatment, investigators use a positive psychology approach. The smartphone app administers positive psychology exercises to enhance and/or maintain positive affect, which is hypothesized to stimulate nondaily smokers to enact healthier alternatives to smoking by broadening their thought-action repertoire, increasing confidence, and decreasing craving and defensiveness about smoking-related health information.
11352221|NCT03951766|FG000|Participant Flow|Smiling Instead of Smoking App|"This is a pilot study; all participants will use the app in the same manner/time period (i.e., this is a single-arm trial)t.~Smiling Instead of Smoking (SiS) App Version 2: The investigators have developed a smartphone app that acts as a behavioral, in-the-pocket coach and uses positive psychology exercises to enhance quitting success. It is anonymous, portable, and provides just-in-time support, an important feature for smokers who smoke under specific conditions and circumstances. To support treatment, investigators use a positive psychology approach. The smartphone app administers positive psychology exercises to enhance and/or maintain positive affect, which is hypothesized to stimulate nondaily smokers to enact healthier alternatives to smoking by broadening their thought-action repertoire, increasing confidence, and decreasing craving and defensiveness about smoking-related health information."
11352222|NCT03951766|OG000|Outcome|Smiling Instead of Smoking (SiS) App Version 2|Behavioral: Smiling Instead of Smoking (SiS) App Version 2 The investigators have developed a smartphone app that acts as a behavioral, in-the-pocket coach and uses positive psychology exercises to enhance quitting success. It is anonymous, portable, and provides just-in-time support, an important feature for smokers who smoke under specific conditions and circumstances. To support treatment, investigators use a positive psychology approach. The smartphone app administers positive psychology exercises to enhance and/or maintain positive affect, which is hypothesized to stimulate nondaily smokers to enact healthier alternatives to smoking by broadening their thought-action repertoire, increasing confidence, and decreasing craving and defensiveness about smoking-related health information.
11352223|NCT03951766|OG000|Outcome|Smiling Instead of Smoking (SiS) App Version 2|Behavioral: Smiling Instead of Smoking (SiS) Smartphone App Version 2
11352224|NCT03951766|EG000|Reported Event|Smiling Instead of Smoking (SiS) App Version 2|Behavioral: Smiling Instead of Smoking (SiS) Smartphone App Version 2
11352225|NCT03961100|BG000|Baseline|Part 1 T1T2R Sequence|Participants were randomly assigned to one of the three treatment sequences (T1T2R, T2RT1, RT1T2). In each treatment sequences, participants crossed over to three periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 600 milligram (mg) oral dose under fed condition in three different formulations. Test formulation 1 (T1): film-coated mini-tablet; Test formulation 2 (T2): film-coated mini-tablet; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352226|NCT03961100|BG001|Baseline|Part 1 T2RT1 Sequence|Participants were randomly assigned to one of the three treatment sequences (T1T2R, T2RT1, RT1T2). In each treatment sequences, participants crossed over to three periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 600 milligram (mg) oral dose under fed condition in three different formulations. Test formulation 1 (T1): film-coated mini-tablet; Test formulation 2 (T2): film-coated mini-tablet; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352227|NCT03961100|BG002|Baseline|Part 1 RT1T2 Sequence|Participants were randomly assigned to one of the three treatment sequences (T1T2R, T2RT1, RT1T2). In each treatment sequences, participants crossed over to three periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 600 milligram (mg) oral dose under fed condition in three different formulations. Test formulation 1 (T1): film-coated mini-tablet; Test formulation 2 (T2): film-coated mini-tablet; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352228|NCT03961100|BG003|Baseline|Part 2 TR Sequence|Participants were randomly assigned to one of the two treatment sequences (TR, RT). In each treatment sequences, participants crossed over to two periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 200 mg oral dose under fasted condition in two different formulations. Test formulation (T): hydroxypropyl methylcellulose (HPMC) capsule; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352229|NCT03961100|BG004|Baseline|Part 2 RT Sequence|Participants were randomly assigned to one of the two treatment sequences (TR, RT). In each treatment sequences, participants crossed over to two periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 200 mg oral dose under fasted condition in two different formulations. Test formulation (T): hydroxypropyl methylcellulose (HPMC) capsule; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352230|NCT03961100|BG005|Baseline|Total|Total of all reporting groups
11352231|NCT03961100|FG000|Participant Flow|Part 1 T1T2R Sequence|Participants were randomly assigned to one of the three treatment sequences (T1T2R, T2RT1, RT1T2). In each treatment sequences, participants crossed over to three periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 600 milligram (mg) oral dose under fed condition in three different formulations. Test formulation 1 (T1): film-coated mini-tablet; Test formulation 2 (T2): film-coated mini-tablet; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352232|NCT03961100|FG001|Participant Flow|Part 1 T2RT1 Sequence|Participants were randomly assigned to one of the three treatment sequences (T1T2R, T2RT1, RT1T2). In each treatment sequences, participants crossed over to three periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 600 milligram (mg) oral dose under fed condition in three different formulations. Test formulation 1 (T1): film-coated mini-tablet; Test formulation 2 (T2): film-coated mini-tablet; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352233|NCT03961100|FG002|Participant Flow|Part 1 RT1T2 Sequence|Participants were randomly assigned to one of the three treatment sequences (T1T2R, T2RT1, RT1T2). In each treatment sequences, participants crossed over to three periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 600 milligram (mg) oral dose under fed condition in three different formulations. Test formulation 1 (T1): film-coated mini-tablet; Test formulation 2 (T2): film-coated mini-tablet; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352234|NCT03961100|FG003|Participant Flow|Part 2 TR Sequence|Participants were randomly assigned to one of the two treatment sequences (TR, RT). In each treatment sequences, participants crossed over to two periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 200 mg oral dose under fasted condition in two different formulations. Test formulation (T): hydroxypropyl methylcellulose (HPMC) capsule; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352235|NCT03961100|FG004|Participant Flow|Part 2 RT Sequence|Participants were randomly assigned to one of the two treatment sequences (TR, RT). In each treatment sequences, participants crossed over to two periods (each period=7 days) taking different formulations of entrectinib. Entrectinib was administered as a single 200 mg oral dose under fasted condition in two different formulations. Test formulation (T): hydroxypropyl methylcellulose (HPMC) capsule; Reference formulation (R): hard capsule. The washout period between entrectinib doses was at least 14 days.
11352236|NCT03961100|OG000|Outcome|Part 1 T1/F15 (Test Formulation 1)|"Participants who received a single oral dose of 600 mg (240 × 2.5 mg) entrectinib film-coated mini-tablets in each period (one period=7 days) sprinkled on to, and mixed with, one tablespoon (15 mL) of yoghurt within 30 minutes of consumption of a standardized light pediatric breakfast. The washout period between entrectinib doses was at least 14 days."
11352237|NCT03961100|OG001|Outcome|Part 1 T2/F16 (Test Formulation 2)|"Participants who received a single oral dose of 600 mg (240 × 2.5 mg) entrectinib film-coated mini-tablets in each period (one period=7 days) sprinkled on to, and mixed with, one tablespoon (15 mL) of yoghurt within 30 minutes of consumption of a standardized light pediatric breakfast. The washout period between entrectinib doses was at least 14 days."
11352238|NCT03961100|OG002|Outcome|Part 1 R/F06 (Reference Formulation)|"Participants who received a single oral dose of 600 mg (3 × 200 mg) entrectinib hard capsule in each period (one period=7 days) swallowed whole with approximately 240 mL of water within 30 minutes of consumption of a standardized light pediatric breakfast. The washout period between entrectinib doses was at least 14 days."
11352239|NCT03961100|OG003|Outcome|Part 2 T/F06 Coarse (Test Formulation)|Participants who received a single oral dose of 1 x 200 mg entrectinib hydroxypropyl methylcellulose (HPMC) capsule in each period (one period=7 days) swallowed whole with approximately 240 mL of water after an overnight fast (minimum 8 hours). The washout period between entrectinib doses was at least 14 days.
11352240|NCT03961100|OG004|Outcome|Part 2 R/F06 Fine (Reference Formulation)|Participants who received a single oral dose of 1 x 200 mg entrectinib hard capsule in each period (one period=7 days) swallowed whole with approximately 240 mL of water after an overnight fast (minimum 8 hours). The washout period between entrectinib doses was at least 14 days.
11352241|NCT03961100|EG000|Reported Event|Part 1 T1/F15 (Test Formulation 1)|"Participants who received a single oral dose of 600 mg (240 × 2.5 mg) entrectinib film-coated mini-tablets in each period (one period=7 days) sprinkled on to, and mixed with, one tablespoon (15 mL) of yoghurt within 30 minutes of consumption of a standardized light pediatric breakfast. The washout period between entrectinib doses was at least 14 days."
11352242|NCT03961100|EG001|Reported Event|Part 1 T2/F16 (Test Formulation 2)|"Participants who received a single oral dose of 600 mg (240 × 2.5 mg) entrectinib film-coated mini-tablets in each period (one period=7 days) sprinkled on to, and mixed with, one tablespoon (15 mL) of yoghurt within 30 minutes of consumption of a standardized light pediatric breakfast. The washout period between entrectinib doses was at least 14 days."
11352243|NCT03961100|EG002|Reported Event|Part 1 R/F06 (Reference Formulation)|"Participants who received a single oral dose of 600 mg (3 × 200 mg) entrectinib hard capsule in each period (one period=7 days) swallowed whole with approximately 240 mL of water within 30 minutes of consumption of a standardized light pediatric breakfast. The washout period between entrectinib doses was at least 14 days."
11352244|NCT03961100|EG003|Reported Event|Part 2 T/F06 Coarse (Test Formulation)|Participants who received a single oral dose of 1 x 200 mg entrectinib hydroxypropyl methylcellulose (HPMC) capsule in each period (one period=7 days) swallowed whole with approximately 240 mL of water after an overnight fast (minimum 8 hours). The washout period between entrectinib doses was at least 14 days.
11352245|NCT03961100|EG004|Reported Event|Part 2 R/F06 Fine (Reference Formulation)|Participants who received a single oral dose of 1 x 200 mg entrectinib hard capsule in each period (one period=7 days) swallowed whole with approximately 240 mL of water after an overnight fast (minimum 8 hours). The washout period between entrectinib doses was at least 14 days.
11352246|NCT03950856|BG000|Baseline|V114 Lot 1|Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352247|NCT03950856|BG001|Baseline|V114 Lot 2|Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352248|NCT03950856|BG002|Baseline|V114 Lot 3|Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352249|NCT03950856|BG003|Baseline|Prevnar13™|Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
11352250|NCT03950856|BG004|Baseline|Total|Total of all reporting groups
11352251|NCT03950856|FG000|Participant Flow|V114 Lot 1|Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352252|NCT03950856|FG001|Participant Flow|V114 Lot 2|Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352253|NCT03950856|FG002|Participant Flow|V114 Lot 3|Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352254|NCT03950856|FG003|Participant Flow|Prevnar13™|Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
11352255|NCT03950856|OG000|Outcome|V114 Lot 1|Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352256|NCT03950856|OG001|Outcome|V114 Lot 2|Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352257|NCT03950856|OG002|Outcome|V114 Lot 3|Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352258|NCT03950856|OG003|Outcome|Prevnar13™|Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
11352259|NCT03950856|OG000|Outcome|V114 Combined Lots 1,2 and 3|Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352260|NCT03950856|OG001|Outcome|Prevnar13™|Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
11352261|NCT03950856|EG000|Reported Event|V114 Lot 1|Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352262|NCT03950856|EG001|Reported Event|V114 Lot 2|Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352263|NCT03950856|EG002|Reported Event|V114 Lot 3|Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
11352264|NCT03950856|EG003|Reported Event|Prevnar 13™|Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
11352265|NCT03947983|BG000|Baseline|Intervention Group|"The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors~Sensor-controlled digital game (SCDG): The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app.~The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors."
11352266|NCT03947983|BG001|Baseline|Control Group|"The control group will receive only the weight monitoring and physical activity sensors~Sensor Only: Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG."
11352267|NCT03947983|BG002|Baseline|Total|Total of all reporting groups
11352268|NCT03947983|FG000|Participant Flow|Intervention Group|"The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors~Sensor-controlled digital game (SCDG): The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal heart failure (HF) health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app.~The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors."
11352269|NCT03947983|FG001|Participant Flow|Control Group|"The control group will receive only the weight monitoring and physical activity sensors~Sensor Only: Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based heart failure (HF) educational material.However, the data from the Withings sensors will not be routed to the SCDG."
11352270|NCT03947983|OG000|Outcome|Intervention Group|"The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors~Sensor-controlled digital game (SCDG): The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app.~The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors."
11352271|NCT03947983|OG001|Outcome|Control Group|"The control group will receive only the weight monitoring and physical activity sensors~Sensor Only: Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG."
11352272|NCT03947983|EG000|Reported Event|Intervention Group|"The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors~Sensor-controlled digital game (SCDG): The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app.~The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors."
11352273|NCT03947983|EG001|Reported Event|Control Group|"The control group will receive only the weight monitoring and physical activity sensors~Sensor Only: Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG."
11352274|NCT03960658|BG000|Baseline|Ketamine and Prolonged Exposure|Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
11352275|NCT03960658|FG000|Participant Flow|Ketamine and Prolonged Exposure|Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
11352276|NCT03960658|OG000|Outcome|Ketamine and Prolonged Exposure|Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
11352277|NCT03960658|EG000|Reported Event|Ketamine and Prolonged Exposure|Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
11352278|NCT03959332|BG000|Baseline|Baloxavir Marboxil 40 mg|Administered orally on Day 1
11352279|NCT03959332|BG001|Baseline|Baloxavir Marboxil 80 mg|Administered orally on Day 1
11352280|NCT03959332|BG002|Baseline|Total|Total of all reporting groups
11352281|NCT03959332|FG000|Participant Flow|Baloxavir Marboxil 40 mg|Administered orally on Day 1
11352282|NCT03959332|FG001|Participant Flow|Baloxavir Marboxil 80 mg|Administered orally on Day 1
11352283|NCT03959332|OG000|Outcome|Baloxavir Marboxil 40 mg|Administered orally on Day 1
11352284|NCT03959332|OG001|Outcome|Baloxavir Marboxil 80 mg|Administered orally on Day 1
11352285|NCT03959332|EG000|Reported Event|Baloxavir Marboxil 40 mg|Administered orally on Day 1
11352286|NCT03959332|EG001|Reported Event|Baloxavir Marboxil 80 mg|Administered orally on Day 1
11352287|NCT03959189|BG000|Baseline|Cohort 1: 1 mg ERX-963|"Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.~Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352288|NCT03959189|BG001|Baseline|Cohort 2: 2 mg ERX-963|"Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352289|NCT03959189|BG002|Baseline|Total|Total of all reporting groups
11352290|NCT03959189|FG000|Participant Flow|Cohort 1: 1 mg ERX-963|"Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.~Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352291|NCT03959189|FG001|Participant Flow|Cohort 2: 2 mg ERX-963|"Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352292|NCT03959189|OG000|Outcome|Cohort 1: 1 mg ERX-963|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.~Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352293|NCT03959189|OG001|Outcome|Cohort 2: 2 mg ERX-963|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352294|NCT03959189|OG000|Outcome|Cohort 1: Placebo Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352295|NCT03959189|OG001|Outcome|Cohort 1: 1 mg ERX-963 Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.~Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352296|NCT03959189|OG002|Outcome|Cohort 2: Placebo Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352297|NCT03959189|OG003|Outcome|Cohort 2: 2 mg ERX-963 Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352298|NCT03959189|OG001|Outcome|Cohort 1: 1 mg ERX-963 Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352299|NCT03959189|EG000|Reported Event|Cohort 1: Placebo Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352300|NCT03959189|EG001|Reported Event|Cohort 1: 1 mg ERX-963 Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.~Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352301|NCT03959189|EG002|Reported Event|Cohort 2: Placebo Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352302|NCT03959189|EG003|Reported Event|Cohort 2: 2 mg ERX-963 Period|"The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.~Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.~Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo."
11352303|NCT03956550|BG000|Baseline|Placebo|Participants received matching placebo intravenously every 4 weeks (Q4W)
11352304|NCT03956550|BG001|Baseline|REGN5069 100 mg Q4W|Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
11352305|NCT03956550|BG002|Baseline|REGN5069 1000 mg Q4W|Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
11352306|NCT03956550|BG003|Baseline|Total|Total of all reporting groups
11352307|NCT03956550|FG000|Participant Flow|Placebo|Participants received matching placebo intravenously every 4 weeks (Q4W)
11352308|NCT03956550|FG001|Participant Flow|REGN5069 100 mg Q4W|Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
11352309|NCT03956550|FG002|Participant Flow|REGN5069 1000 mg Q4W|Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
11352310|NCT03956550|OG000|Outcome|Placebo|Participants received matching placebo intravenously every 4 weeks (Q4W)
11352311|NCT03956550|OG001|Outcome|REGN5069 100 mg Q4W|Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
11352312|NCT03956550|OG002|Outcome|REGN5069 1000 mg Q4W|Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
11352313|NCT03956550|EG000|Reported Event|Placebo|Participants received matching placebo intravenously every 4 weeks (Q4W)
11352314|NCT03956550|EG001|Reported Event|REGN5069 100 mg IV Q4W|Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
11352315|NCT03956550|EG002|Reported Event|REGN5069 1000 mg IV Q4W|Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
11352316|NCT03954158|BG000|Baseline|Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352317|NCT03954158|BG001|Baseline|Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352318|NCT03954158|BG002|Baseline|Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years|Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352319|NCT03954158|BG003|Baseline|Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years|Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352320|NCT03954158|BG004|Baseline|Total|Total of all reporting groups
11352321|NCT03954158|FG000|Participant Flow|Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years|Participants in this reporting arm were of age greater than or equal to (>=) 12 years. Investigator determined 2 target lesions of same atopic dermatitis (AD) severity in each participant at baseline (Day 1). Crisaborole ointment 2 percent (%) was applied once daily (QD) to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352322|NCT03954158|FG001|Participant Flow|Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied twice daily (BID) to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352323|NCT03954158|FG002|Participant Flow|Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years|Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352324|NCT03954158|FG003|Participant Flow|Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years|Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352325|NCT03954158|OG000|Outcome|Crisaborole 2% QD: Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352326|NCT03954158|OG001|Outcome|Vehicle QD: Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11230659|NCT02407704|BG002|Baseline|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230660|NCT02407704|BG003|Baseline|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11230661|NCT02407704|BG004|Baseline|Total|Total of all reporting groups
11230662|NCT02407704|FG000|Participant Flow|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230663|NCT02407704|FG001|Participant Flow|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11230664|NCT02407704|FG002|Participant Flow|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230665|NCT02407704|FG003|Participant Flow|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11230666|NCT02407704|OG000|Outcome|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230667|NCT02407704|OG001|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11335533|NCT03552289|BG001|Baseline|Conventional Angioplasty Balloon Catheters|"Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.~Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula"
11335534|NCT03552289|BG002|Baseline|Total|Total of all reporting groups
11167276|NCT01977898|OG001|Outcome|Saline|"Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.~Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection."
11167277|NCT01977898|EG000|Reported Event|Morphine|"Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.~Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection."
11167278|NCT01977898|EG001|Reported Event|Saline|"Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.~Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection."
11167279|NCT01977937|BG000|Baseline|Gabapentin|"Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital.~Gabapentin"
11167280|NCT01977937|BG001|Baseline|Simple Syrup|"Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital.~Simple Syrup"
11167281|NCT01977937|BG002|Baseline|Total|Total of all reporting groups
11167282|NCT01977937|FG000|Participant Flow|Gabapentin|"Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital.~Gabapentin"
11167283|NCT01977937|FG001|Participant Flow|Simple Syrup|"Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital.~Simple Syrup"
11167284|NCT01977937|OG000|Outcome|Gabapentin|"Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital.~Gabapentin"
11167285|NCT01977937|OG001|Outcome|Simple Syrup|"Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital.~Simple Syrup"
11167286|NCT01977937|EG000|Reported Event|Gabapentin|"Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital.~Gabapentin"
11167287|NCT01977937|EG001|Reported Event|Simple Syrup|"Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital.~Simple Syrup"
11167288|NCT01978093|BG000|Baseline|HibCY Group|Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
11167289|NCT01978093|BG001|Baseline|PedHIB Group|Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
11167290|NCT01978093|BG002|Baseline|Total|Total of all reporting groups
11167291|NCT01978093|FG000|Participant Flow|HibCY Group|Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
11167292|NCT01978093|FG001|Participant Flow|PedHIB Group|Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
11167293|NCT01978093|OG000|Outcome|HibCY Group|Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
10914697|NCT00632489|FG002|Participant Flow|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
11089428|NCT01523782|EG002|Reported Event|GRASPA 150 IU/kg|"Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase~GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase"
11092131|NCT01537419|EG001|Reported Event|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
11092132|NCT01537432|BG000|Baseline|AIN457 300mg|AIN457 300mg subcutaneously weekly
11092133|NCT01537432|BG001|Baseline|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
11092134|NCT01537432|BG002|Baseline|Total|Total of all reporting groups
11092135|NCT01537432|FG000|Participant Flow|AIN457 300mg|AIN457 300mg subcutaneously weekly
11092136|NCT01537432|FG001|Participant Flow|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
11092137|NCT01537432|OG000|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
11092138|NCT01537432|OG001|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
11092139|NCT01537432|EG000|Reported Event|AIN457 300 mg|AIN457 300mg subcutaneously weekly
11092140|NCT01537432|EG001|Reported Event|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
11092141|NCT01537549|BG000|Baseline|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
11092142|NCT01537549|FG000|Participant Flow|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
11092143|NCT01537549|OG000|Outcome|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
11092144|NCT01537549|OG000|Outcome|Juvenon at Baseline|at Baseline, no drug taken yet
11092145|NCT01537549|OG001|Outcome|Juvenon at 1 Month|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily (1 month)
11092146|NCT01537549|EG000|Reported Event|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
11092147|NCT01537666|BG000|Baseline|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
11092148|NCT01537666|BG001|Baseline|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
11092149|NCT01537666|BG002|Baseline|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
11092150|NCT01537666|BG003|Baseline|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
11092151|NCT01537666|BG004|Baseline|Total|Total of all reporting groups
11092152|NCT01537666|FG000|Participant Flow|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
11092153|NCT01537666|FG001|Participant Flow|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
11092154|NCT01537666|FG002|Participant Flow|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
11092155|NCT01537666|FG003|Participant Flow|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
11092156|NCT01537666|OG000|Outcome|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
11092157|NCT01537666|OG001|Outcome|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
11092158|NCT01537666|OG002|Outcome|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
11092159|NCT01537666|OG003|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|Single IV dose of Vancomycin 250 mg in Healthy Volunteers. Group comprised of 2 subjects from each of the AeroVanc in Healthy Volunteers groups.
11230668|NCT02407704|OG002|Outcome|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230669|NCT02407704|OG003|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11230670|NCT02407704|OG001|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11230671|NCT02407704|OG003|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11230672|NCT02407704|OG001|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230673|NCT02407704|OG003|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230674|NCT02407704|EG000|Reported Event|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11230675|NCT02407704|EG001|Reported Event|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11230676|NCT02407704|EG002|Reported Event|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
11335535|NCT03552289|FG000|Participant Flow|Cook Enforcer Balloon Catheter|"The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.~Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula"
11230677|NCT02407704|EG003|Reported Event|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
11230678|NCT02407756|BG000|Baseline|Dupilumab 2mg/kg: Adolescents|Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
11230679|NCT02407756|BG001|Baseline|Dupilumab 2mg/kg: Children|Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
11230680|NCT02407756|BG002|Baseline|Dupilumab 4mg/kg: Adolescents|Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
11230681|NCT02407756|BG003|Baseline|Dupilumab 4mg/kg: Children|Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
11230682|NCT02407756|BG004|Baseline|Total|Total of all reporting groups
11230683|NCT02407756|FG000|Participant Flow|Dupilumab 2mg/kg: Adolescents|Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
11230684|NCT02407756|FG001|Participant Flow|Dupilumab 2mg/kg: Children|Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
11230685|NCT02407756|FG002|Participant Flow|Dupilumab 4mg/kg: Adolescents|Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
11230686|NCT02407756|FG003|Participant Flow|Dupilumab 4mg/kg: Children|Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
11230687|NCT02407756|OG000|Outcome|Dupilumab 2mg/kg: Adolescents|Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
11230688|NCT02407756|OG001|Outcome|Dupilumab 2mg/kg: Children|Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
11230689|NCT02407756|OG002|Outcome|Dupilumab 4mg/kg: Adolescents|Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
11230690|NCT02407756|OG003|Outcome|Dupilumab 4mg/kg: Children|Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
11230691|NCT02407756|EG000|Reported Event|Dupilumab 2mg/kg: Adolescents|Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
11230692|NCT02407756|EG001|Reported Event|Dupilumab 2mg/kg: Children|Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
11230693|NCT02407756|EG002|Reported Event|Dupilumab 4 mg/kg: Adolescents|Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
11230694|NCT02407756|EG003|Reported Event|Dupilumab 4 mg/kg: Children|Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period), then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
11230695|NCT02407990|BG000|Baseline|BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg|Participants were dosed at 0.5 milligrams/kilograms (mg/kg), once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 28 days in duration.
11230696|NCT02407990|BG001|Baseline|BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg|Participants were dosed at 2.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration
11230697|NCT02407990|BG002|Baseline|BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg|Participants were dosed at 5.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 28 days in duration
11230698|NCT02407990|BG003|Baseline|BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg|Participants were dosed at 10.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230699|NCT02407990|BG004|Baseline|BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg|Participants received selected dosing based on Part 1 of 2.0 mg/kg once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230700|NCT02407990|BG005|Baseline|BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg|Participants received selected dosing based on Part 1 of 5.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230701|NCT02407990|BG006|Baseline|BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg|Participants received selected maximum tolerated dose of 200.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230702|NCT02407990|BG007|Baseline|BGB-A317 Phase 1B|Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, subject discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
11230703|NCT02407990|BG008|Baseline|Total|Total of all reporting groups
11230704|NCT02407990|FG000|Participant Flow|BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg|Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230705|NCT02407990|FG001|Participant Flow|BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg|Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230706|NCT02407990|FG002|Participant Flow|BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg|Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230707|NCT02407990|FG003|Participant Flow|BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg|Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230708|NCT02407990|FG004|Participant Flow|BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg|Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230709|NCT02407990|FG005|Participant Flow|BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg|Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230710|NCT02407990|FG006|Participant Flow|BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg|Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230711|NCT02407990|FG007|Participant Flow|BGB-A317 Phase 1B|Participants were dosed at 5 mg/kg tislelizumab, Q3W until confirmed disease progression, intolerable toxicity, subject discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
11230712|NCT02407990|OG000|Outcome|BGB-A317 Phase 1A|In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected maximum tolerated dose (MTD), which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
10914698|NCT00632489|OG000|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
11230713|NCT02407990|OG000|Outcome|BGB-A317 Phase 1A|In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230714|NCT02407990|OG000|Outcome|BGB-A317 Phase 1B|Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
11230715|NCT02407990|OG000|Outcome|BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg|Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230716|NCT02407990|OG001|Outcome|BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg|Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11089429|NCT01523808|BG000|Baseline|GRASPA 25|"Participants received one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11230717|NCT02407990|OG002|Outcome|BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg|Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230718|NCT02407990|OG003|Outcome|BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg|Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230719|NCT02407990|OG004|Outcome|BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg|Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230720|NCT02407990|OG005|Outcome|BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg|Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11167294|NCT01978093|OG001|Outcome|PedHIB Group|Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
11167295|NCT01978093|OG000|Outcome|HibCY Group|Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
11167296|NCT01978093|OG000|Outcome|HibCY Group|Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.
11167297|NCT01978093|OG001|Outcome|PedHIB Group|Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.
11167298|NCT01978093|EG000|Reported Event|HibCY Group|Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
11167299|NCT01978093|EG001|Reported Event|PedHIB Group|Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
11167300|NCT01978119|BG000|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 3-week washout period. One actuations of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI or one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI. Salbutamol/albuterol was provided to use as rescue medication.
11167301|NCT01978119|FG000|Participant Flow|Sequence 1: Pl MD-DPI/FSC CB-DPI Then FSC MD-DPI/Pl CB-DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) and one inhalation of single capsule containing Fluticasone salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self administered one inhalation of FSC (250/50 mcg) via the multi-dose DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
11167302|NCT01978119|FG001|Participant Flow|Sequence 2: FSC MD-DPI/Pl CB-DPI Then Pl MD-DPI/FSC CB-DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a multi-dose DPI and one inhalation of Placebo via a capsule-based unit dose DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self admnistered one inhalation of matching Placebo via a multi-dose DPI and one inhalation of FSC (250/50 mcg) via a capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
11167303|NCT01978119|OG000|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
11167304|NCT01978119|OG001|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
11167305|NCT01978119|EG000|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
11167306|NCT01978119|EG001|Reported Event|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
11167307|NCT01978145|BG000|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 4-week washout period. One inhalation of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI or one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI . Salbutamol/albuterol was provided to use as rescue medication.
11352327|NCT03954158|OG002|Outcome|Crisaborole 2% BID: Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352328|NCT03954158|OG003|Outcome|Vehicle BID: Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352329|NCT03954158|OG004|Outcome|Crisaborole 2% QD: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352330|NCT03954158|OG005|Outcome|Vehicle QD: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352331|NCT03954158|OG006|Outcome|Crisaborole 2% BID: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352332|NCT03954158|OG007|Outcome|Vehicle BID: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352333|NCT03954158|OG001|Outcome|Crisaborole 2% BID: Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352334|NCT03954158|OG002|Outcome|Crisaborole 2% QD: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352335|NCT03954158|OG003|Outcome|Crisaborole 2% BID: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352336|NCT03954158|OG000|Outcome|Crisaborole 2% QD Sub-group: Age Group 6 to 11 Years|Participants in this sub-group were of age 6 to 11 Years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352337|NCT03954158|OG001|Outcome|Vehicle QD Sub-group: Age Group 6 to 11 Years|Participants in this sub-group were of age 6 to 11 Years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352338|NCT03954158|OG002|Outcome|Crisaborole 2% BID Sub-group: Age Group 6 to 11 Years|Participants in this sub-group were of age 6 to 11 Years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352339|NCT03954158|OG003|Outcome|Vehicle BID Sub-group: Age Group 6 to 11 Years|Participants in this sub-group were of age 6 to 11 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352340|NCT03954158|OG000|Outcome|Crisaborole 2% QD: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
10914699|NCT00632489|OG001|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
11352341|NCT03954158|OG001|Outcome|Vehicle QD: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352342|NCT03954158|OG002|Outcome|Crisaborole 2% BID: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11167308|NCT01978145|FG000|Participant Flow|Sequence 1: Pl MD DPI/FSC CB DPI Then FSC MD DPI/Pl CB DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) followed by one inhalation of single capsule containing Fluticasone propionate and salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self administered one inhalation of FSC (250/50 mcg) via the MD DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication
11167309|NCT01978145|FG001|Participant Flow|Sequence 2: FSC MD DPI/Pl CB DPI Then Pl MD DPI/FSC CB DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a MD DPI and one inhalation of Placebo via a CB DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self admnistered one inhalation of matching Placebo via a MD DPI and one inhalation of FSC (250/50 mcg) via a CB DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
11167310|NCT01978145|OG000|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
11167311|NCT01978145|OG001|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
11167312|NCT01978145|EG000|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
11167313|NCT01978145|EG001|Reported Event|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
11167314|NCT01978184|BG000|Baseline|Gemcitabine + Abraxane|Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m^2 of gemcitabine followed by a 125 mg/m^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.
11167315|NCT01978184|BG001|Baseline|Gemcitabine + Abraxane and Hydroxychloroquine|"Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m^2 of gemcitabine followed by a 125 mg/m^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.~Hydroxychloroquine oral capsules taken once or twice a daily at a dose of 1200mg. The first dose of hydroxychloroquine taken on Day 1 (48 hours before the first infusion of gemcitabine/abraxane), and continued daily until one day before surgery."
11167316|NCT01978184|BG002|Baseline|Total|Total of all reporting groups
11167317|NCT01978184|FG000|Participant Flow|Gemcitabine + Abraxane|Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m^2 of gemcitabine followed by a 125 mg/m^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.
11167318|NCT01978184|FG001|Participant Flow|Gemcitabine + Abraxane and Hydroxychloroquine|"Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m^2 of gemcitabine followed by a 125 mg/m^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.~Hydroxychloroquine oral capsules taken once or twice a daily at a dose of 1200mg. The first dose of hydroxychloroquine taken on Day 1 (48 hours before the first infusion of gemcitabine/abraxane), and continued daily until one day before surgery."
11167319|NCT01978184|OG000|Outcome|Gemcitabine + Abraxane|Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m^2 of gemcitabine followed by a 125 mg/m^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.
11167320|NCT01978184|OG001|Outcome|Gemcitabine + Abraxane and Hydroxychloroquine|"Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m^2 of gemcitabine followed by a 125 mg/m^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.~Hydroxychloroquine oral capsules taken once or twice a daily at a dose of 1200mg. The first dose of hydroxychloroquine taken on Day 1 (48 hours before the first infusion of gemcitabine/abraxane), and continued daily until one day before surgery."
11167321|NCT01978184|EG000|Reported Event|Gemcitabine + Abraxane|Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m^2 of gemcitabine followed by a 125 mg/m^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.
11230721|NCT02407990|OG006|Outcome|BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg|Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230722|NCT02407990|OG000|Outcome|BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg|Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W). until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230723|NCT02407990|OG004|Outcome|BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg|Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W). until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230724|NCT02407990|OG000|Outcome|BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg|Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230725|NCT02407990|OG000|Outcome|BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg|Participants were dosed at 0.5 milligrams/kilograms (mg/kg), once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230726|NCT02407990|OG001|Outcome|BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg|Participants were dosed at 2.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230727|NCT02407990|OG002|Outcome|BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg|Participants were dosed at 5.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration
11230728|NCT02407990|OG003|Outcome|BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg|Participants were dosed at 10.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
11230729|NCT02407990|OG004|Outcome|BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg|Participants received selected dosing based on Part 1 of 2.0 mg/kg once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230730|NCT02407990|OG005|Outcome|BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg and BGB-A317 Phase 1B|"Phase 1A: Participants received selected dosing based on Part 1 of 5.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 21 days in duration.~Phase 1B; Participants were dosed at 5 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration."
11230731|NCT02407990|OG006|Outcome|BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg|Participants received selected maximum tolerated dose of 200.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
11230732|NCT02407990|EG000|Reported Event|BGB-A317 Phase 1A|In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which is 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 21 days in duration.
11230733|NCT02407990|EG001|Reported Event|BGB-A317 Phase 1B|Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
11230734|NCT02408016|BG000|Baseline|Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)|"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11230735|NCT02408016|BG001|Baseline|Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)|"Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11230736|NCT02408016|BG002|Baseline|Arm II (T Lymphocytes, IL-2, Surgery)|"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgical resection"
11230737|NCT02408016|BG003|Baseline|Total|Total of all reporting groups
11230738|NCT02408016|FG000|Participant Flow|Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)|"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11230739|NCT02408016|FG001|Participant Flow|Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)|"Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11230740|NCT02408016|FG002|Participant Flow|Arm II (T Lymphocytes, IL-2, Surgery)|"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgical resection"
11230741|NCT02408016|OG000|Outcome|Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)|"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11230742|NCT02408016|OG001|Outcome|Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)|"Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11230743|NCT02408016|OG002|Outcome|Arm II (T Lymphocytes, IL-2, Surgery)|"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgical resection"
11230744|NCT02408016|EG000|Reported Event|Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)|"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11230745|NCT02408016|EG001|Reported Event|Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)|"Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11230746|NCT02408016|EG002|Reported Event|Arm II (T Lymphocytes, IL-2, Surgery)|"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgical resection"
11230747|NCT02408120|BG000|Baseline|Insulin Aspart for BG > 140 mg/dL|Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.
11230748|NCT02408120|BG001|Baseline|Insulin Aspart for BG > 260 mg/dL|Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
11230749|NCT02408120|BG002|Baseline|Total|Total of all reporting groups
11230750|NCT02408120|FG000|Participant Flow|Insulin Aspart for BG > 140 mg/dL|Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.
11230751|NCT02408120|FG001|Participant Flow|Insulin Aspart for BG > 260 mg/dL|Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
11230752|NCT02408120|OG000|Outcome|Insulin Aspart for BG > 140 mg/dL|Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.
11230753|NCT02408120|OG001|Outcome|Insulin Aspart for BG > 260 mg/dL|Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
11230754|NCT02408120|EG000|Reported Event|Insulin Aspart for BG > 140 mg/dL|Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.
11230755|NCT02408120|EG001|Reported Event|Insulin Aspart for BG > 260 mg/dL|Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
11230756|NCT02408198|BG000|Baseline|Immediate Therapy|"Therapy will be delivered for a period of 6 weeks immediately after randomisation~Anxiety intervention: The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life."
11230757|NCT02408198|BG001|Baseline|Delayed Therapy|Therapy will be delayed until 10 weeks following randomisation, and then delivered over a 6 week period
11230758|NCT02408198|BG002|Baseline|Total|Total of all reporting groups
11230759|NCT02408198|FG000|Participant Flow|Immediate Therapy|"Therapy will be delivered for a period of 6 weeks immediately after randomisation~Anxiety intervention: The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life."
11230760|NCT02408198|FG001|Participant Flow|Delayed Therapy|Therapy will be delayed until 10 weeks following randomisation, and then delivered over a 6 week period
11230761|NCT02408198|OG000|Outcome|Immediate Therapy|"Therapy will be delivered for a period of 6 weeks immediately after randomisation~Anxiety intervention: The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life."
11230762|NCT02408198|OG001|Outcome|Delayed Therapy|Therapy will be delayed until 10 weeks following randomisation, and then delivered over a 6 week period
11230763|NCT02408198|EG000|Reported Event|Immediate Therapy|"Therapy will be delivered for a period of 6 weeks immediately after randomisation~Anxiety intervention: The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life."
11230764|NCT02408198|EG001|Reported Event|Delayed Therapy|Therapy will be delayed until 10 weeks following randomisation, and then delivered over a 6 week period
11230765|NCT02408263|BG000|Baseline|THR and TKR|
11230766|NCT02408263|FG000|Participant Flow|Total Hip Replacement (THR)|Patients undergoing unilateral hip replacement (THR) that are between the ages of 18 and 85. Patients with the condition of chronic pain, using long acting opioid medication >6 months will be excluded.
11230767|NCT02408263|FG001|Participant Flow|Total Knee Replacement (TKR)|Patients undergoing unilateral knee replacement (TKR) that are between the ages of 18 and 85. Patients with the condition of chronic pain, using long acting opioid medication >6 months will be excluded.
11230768|NCT02408263|OG000|Outcome|THR and TKR|
11230769|NCT02408263|OG000|Outcome|Total Hip Replacement (THR) and Total Knee Replacement (TKR)|"25 patients receiving a Total Hip Replacement and 25 patients receiving a Total Knee Replacement. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.~THR and TKR: Total Hip Replacement is a surgical procedure whereby the diseased cartilage and bone of the hip joint is surgically replaced with artificial materials. Total Knee Replacement is a procedure which involves replacement of all three compartments of the knee (the medial compartment (inside aspect of the knee), the lateral compartment (outside of the knee) and the patellofemoral compartment (in front of the knee))."
11230770|NCT02408263|EG000|Reported Event|THR and TKR|
11230771|NCT02408445|BG000|Baseline|Testosterone Treatment|"Testosterone cypionate (200 mg/ml) intramuscular injection~testosterone cypionate 200mg/ml: Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses."
11230772|NCT02408445|BG001|Baseline|No Treatment|Subjects will not receive any testosterone during the study period.
11230773|NCT02408445|BG002|Baseline|Total|Total of all reporting groups
11230774|NCT02408445|FG000|Participant Flow|Testosterone Treatment|"Testosterone cypionate (200 mg/ml) intramuscular injection~testosterone cypionate 200mg/ml: Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses."
11230775|NCT02408445|FG001|Participant Flow|No Treatment|Subjects will not receive any testosterone during the study period.
11230776|NCT02408445|OG000|Outcome|Testosterone Treatment|"Testosterone cypionate (200 mg/ml) intramuscular injection~testosterone cypionate 200mg/ml: Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses."
11230777|NCT02408445|OG001|Outcome|No Treatment|Subjects will not receive any testosterone during the study period.
11230778|NCT02408445|EG000|Reported Event|Testosterone Treatment|"Testosterone cypionate (200 mg/ml) intramuscular injection~testosterone cypionate 200mg/ml: Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses."
11167322|NCT01978184|EG001|Reported Event|Gemcitabine + Abraxane and Hydroxychloroquine|"Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m^2 of gemcitabine followed by a 125 mg/m^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.~Hydroxychloroquine oral capsules taken once or twice a daily at a dose of 1200mg. The first dose of hydroxychloroquine taken on Day 1 (48 hours before the first infusion of gemcitabine/abraxane), and continued daily until one day before surgery."
11167323|NCT01978236|BG000|Baseline|Cohort A|Participants in Cohort A received dabrafenib orally 150 milligram twice daily for 7 to 14 days prior to surgery.
11167324|NCT01978236|FG000|Participant Flow|Cohort A|Participants in Cohort A received dabrafenib orally 150 milligram twice daily for 7 to 14 days prior to surgery.
11167325|NCT01978236|OG000|Outcome|Cohort A|Participants in Cohort A received dabrafenib orally 150 milligram twice daily for 7 to 14 days prior to surgery.
11167326|NCT01978236|EG000|Reported Event|Cohort A|Participants in Cohort A received dabrafenib orally 150 milligram twice daily for 7 to 14 days prior to surgery.
11167327|NCT01978262|BG000|Baseline|Healthy Women|"All women are to receive the quadrivalent influenza vaccine~Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly"
11167328|NCT01978262|FG000|Participant Flow|Healthy Women|"All women are to receive the quadrivalent influenza vaccine~Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly"
11167329|NCT01978262|OG000|Outcome|Healthy Women (Vaccine)|"All women are to receive the quadrivalent influenza vaccine~Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly"
11167330|NCT01978262|OG001|Outcome|Healthy Women (Comparator)|"All women are to receive the quadrivalent influenza vaccine~Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly~Comparator Month"
11167331|NCT01978262|EG000|Reported Event|Healthy Women|"All women are to receive the quadrivalent influenza vaccine~Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly"
11167332|NCT01978314|BG000|Baseline|Cohort 1|"Estimated GFR (mL/min)~≥60 mL/min/1.73m2 BSA"
11167333|NCT01978314|BG001|Baseline|Cohort 2|Estimated GFR (mL/min) 30-59 mL/min/1.73m2 BSA
11167334|NCT01978314|BG002|Baseline|Cohort 3|Estimated GFR (mL/min) 15-29 mL/min/1.73m2 BSA
11167335|NCT01978314|BG003|Baseline|Cohort 4|Estimated GFR (mL/min) sCr: ≥2-fold increase or eGFR: >50% decrease compared to baseline
11167336|NCT01978314|BG004|Baseline|Cohort 5|"Estimated GFR (mL/min)~≥60 mL/min/1.73m2 BSA"
11167337|NCT01978314|BG005|Baseline|Total|Total of all reporting groups
11167338|NCT01978314|FG000|Participant Flow|Cohort 1|eGFR renal function ≥60 mL/min for normal function
11167339|NCT01978314|FG001|Participant Flow|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD
11167340|NCT01978314|FG002|Participant Flow|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD
11167341|NCT01978314|FG003|Participant Flow|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI
11167342|NCT01978314|FG004|Participant Flow|Cohort 5|eGFR renal function ≥60 mL/min for normal function
11167343|NCT01978314|OG000|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function
11167344|NCT01978314|OG001|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD
11167345|NCT01978314|OG002|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD
11167346|NCT01978314|OG003|Outcome|Cohort 4|sCr: ≥2-fold increase or eGFR: >50% decrease compared to baseline
11167347|NCT01978314|OG004|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function
11167348|NCT01978314|OG000|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
11167349|NCT01978314|OG001|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
11167350|NCT01978314|OG002|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
11167351|NCT01978314|OG003|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
11167352|NCT01978314|OG004|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
11167353|NCT01978314|OG003|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI
11167354|NCT01978314|OG000|Outcome|Cohort 1|"eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11167355|NCT01978314|OG001|Outcome|Cohort 2|"eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11167356|NCT01978314|OG002|Outcome|Cohort 3|"eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11167357|NCT01978314|OG003|Outcome|Cohort 4|"a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11167358|NCT01978314|OG004|Outcome|Cohort 5|"eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
11167359|NCT01978314|EG000|Reported Event|Cohort 1|eGFR renal function ≥60 mL/min for normal function
11352343|NCT03954158|OG003|Outcome|Vehicle BID: Age Group 2 to 11 Years|Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352344|NCT03954158|OG008|Outcome|Crisaborole 2% QD: All Age Group|Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352345|NCT03954158|OG009|Outcome|Vehicle QD: All Age Group|Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352346|NCT03954158|OG010|Outcome|Crisaborole 2% BID: All Age Group|Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352347|NCT03954158|OG011|Outcome|Vehicle BID: All Age Group|Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).
11352348|NCT03954158|OG000|Outcome|Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352349|NCT03954158|OG001|Outcome|Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352350|NCT03954158|OG002|Outcome|Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years|Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352351|NCT03954158|OG003|Outcome|Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years|Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352352|NCT03954158|EG000|Reported Event|Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11089430|NCT01523808|BG001|Baseline|GRASPA 50|"Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose~3 subjects enrolled; 3 subjects completed"
11352353|NCT03954158|EG001|Reported Event|Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years|Participants in this reporting arm were of age >=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352354|NCT03954158|EG002|Reported Event|Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years|Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352355|NCT03954158|EG003|Reported Event|Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years|Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).
11352356|NCT03958656|BG000|Baseline|LEVEL 1 - 0.66x10^6 Per Kilogram (kg)|0.66x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352357|NCT03958656|BG001|Baseline|LEVEL 2 - 2.0x10^6 Per kg|2.0x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352358|NCT03958656|BG002|Baseline|LEVEL 3 - 6.0x10^6 Per kg|6.0x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352359|NCT03958656|BG003|Baseline|LEVEL 4 - 12.0x10^6 Per kg|12.0x10^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352360|NCT03958656|BG004|Baseline|Total|Total of all reporting groups
11352361|NCT03958656|FG000|Participant Flow|LEVEL 1 - 0.66x10^6 Per Kilogram (kg)|0.66x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352362|NCT03958656|FG001|Participant Flow|LEVEL 2 - 2.0x10^6 Per kg|2.0x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11089431|NCT01523808|BG002|Baseline|GRASPA 100|"Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose~3 subjects enrolled; 1 subject completed"
11352363|NCT03958656|FG002|Participant Flow|LEVEL 3 - 6.0x10^6 Per kg|6.0x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352364|NCT03958656|FG003|Participant Flow|LEVEL 4 - 12.0x10^6 Per kg|12.0x10^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352365|NCT03958656|OG000|Outcome|LEVEL 1 - 0.66x10^6 Per Kilogram (kg)|0.66x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352366|NCT03958656|OG001|Outcome|LEVEL 2 - 2.0x10^6 Per kg|2.0x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352367|NCT03958656|OG002|Outcome|LEVEL 3 - 6.0x10^6 Per kg|6.0x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352368|NCT03958656|OG003|Outcome|LEVEL 4 - 12.0x10^6 Per kg|12.0x10^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352369|NCT03958656|EG000|Reported Event|LEVEL 1 - 0.66x10^6 Per Kilogram (kg)|0.66x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352370|NCT03958656|EG001|Reported Event|LEVEL 2 - 2.0x10^6 Per kg|2.0x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352371|NCT03958656|EG002|Reported Event|LEVEL 3 - 6.0x10^6 Per kg|6.0x10^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352372|NCT03958656|EG003|Reported Event|LEVEL 4 - 12.0x10^6 Per kg|12.0x10^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
11352373|NCT03955133|BG000|Baseline|Intervention|"This is a single arm before and after study with data collection at 4 time points. Only the first and last results were analysed. The results comprise the full range of signs and symptoms associated with possible adverse effects of commonly prescribed medicines.~Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below)."
11352374|NCT03955133|FG000|Participant Flow|Intervention|"This is a single arm before and after study with data collection at 4 time points. The full range of signs and symptoms possibly related to adverse effects of commonly prescribed medicines was collected. Only the first and last data sets were analysed.~Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below)."
11352375|NCT03955133|OG000|Outcome|Intervention|"This is a single arm before and after study with data collection at 4 time points.~Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below)."
11352376|NCT03955133|OG000|Outcome|Single Arm Study|before and after - change in number of problems
11352377|NCT03955133|EG000|Reported Event|Intervention. This is a Single Arm Before and After Study.|There were no adverse events related to the use of the intervention. (The intervention was a paper-based checklist with supporting information.)
11352378|NCT03954626|BG000|Baseline|RTH258|Intravitreal injection
11352379|NCT03954626|FG000|Participant Flow|RTH258|Intravitreal injection
11352380|NCT03954626|OG000|Outcome|RTH258|Intravitreal injection
11352381|NCT03954626|EG000|Reported Event|RTH258|Intravitreal injection
11352382|NCT03951805|BG000|Baseline|Insulin 287 (Titration Algorithm A)|Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 units (U). The dose was adjusted weekly during the treatment period using titration algorithm A with American Diabetes Association (ADA) glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 21 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 21 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352383|NCT03951805|BG001|Baseline|Insulin 287 (Titration Algorithm B)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 U. The dose was adjusted weekly during the treatment period using titration algorithm B with ADA glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 28 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 28 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication
11230779|NCT02408484|BG000|Baseline|Octafibrin|The full analysis set (FAS) population defined according to the intention-to-treat principle, included the 14 patients who received at least one infusion of Octafibrin, and entered the study with a confirmed congenital fibrinogen deficiency.
11230780|NCT02408484|FG000|Participant Flow|Octafibrin|"Of the 15 patients screened,14 patients received at least one infusion of Octafibrin and were included in the study safety (SAF) and full-analysis set (FAS) populations.~For the pharmacokinetic (PK) assessment, 13 patients received a single intravenous infusion of 70mg/kg body weight (BW) of Octafibrin. Dosage of Octafibrin when treating bleeding & surgeries was individually dosed to achieve recommended target fibrinogen plasma levels.8 patients had at least 1 bleeding episode (BE) treated with Octafibrin and constitute the first bleeding (firstBLEED) population, and 8 patients had all documented BEs treated with Octafibrin and therefore constitute the all bleeding (BLEED) population. Target fibrinogen plasma level for minor bleeding were 80-100 mg/dL; major bleeding:130-150mg/dL.~3 patients underwent surgical interventions with at least 1 infusion of Octafibrin (SURG population). Target fibrinogen plasma level for minor surgeries: 80-100 mg/dL; major surgeries: 130-150 mg/dL."
11230781|NCT02408484|OG000|Outcome|Investigator Assessment|Efficacy rating on a 4-point efficacy scale as assessed by the Investigator
11230782|NCT02408484|OG001|Outcome|IDMEAC Assessment|Efficacy rating on a 4-point efficacy scale as assessed by the IDMEAC
11230783|NCT02408484|OG000|Outcome|Investigator Assessment|Efficacy rating on a 2-point efficacy scale as assessed by the Investigator
11230784|NCT02408484|OG001|Outcome|IDMEAC Assessment|Efficacy rating on a 2-point efficacy scale as assessed by the IDMEAC
11230785|NCT02408484|OG000|Outcome|Octafibrin|PK population
11230786|NCT02408484|OG000|Outcome|Change in MCF for the firstBLEED Population|Change in MCF specifically for the first infusions of Octafibrin administered for the treatment of the first bleeding episode of the patients in the firstBLEED population.
11230787|NCT02408484|OG001|Outcome|Change in MCF for the BLEED Population|Change in MCF for the first infusions of Octafibrin administered for the treatment of all bleeding episodes of patients in the BLEED population.
11230788|NCT02408484|OG000|Outcome|Change in Fibrinogen Level for the firstBLEED Population|Change in fibrinogen level specifically for the first infusions of Octafibrin administered for the treatment of the first bleeding episode of the patients in the firstBLEED population.
11230789|NCT02408484|OG001|Outcome|Change in Fibrinogen Level for the BLEED Population|Change in fibrinogen level for the first infusions of Octafibrin administered for the treatment of all bleeding episodes of patients in the BLEED population.
11230790|NCT02408484|OG000|Outcome|Incremental IVR Response for the firstBLEED Population|Incremental IVR response for the first infusions of Octafibrin administered for the treatment of the first bleeding episode of the patients in the firstBLEED population.
11230791|NCT02408484|OG001|Outcome|Incremental IVR Response for the BLEED Population|Incremental IVR response for the first infusions of Octafibrin administered for the treatment of all bleeding episodes of patients in the BLEED population.
11230792|NCT02408484|OG000|Outcome|Investigator|Efficacy assessment for the treatment of all bleeding episodes according to the Investigator
11230793|NCT02408484|OG001|Outcome|IDMEAC|Efficacy assessment for the treatment of all bleeding episode according to the IDMEAC
11230794|NCT02408484|OG000|Outcome|Surgeon|Intra-operative assessment of Octafibrin efficacy in surgical prophylaxis as assessed by the Surgeon.
11230795|NCT02408484|OG001|Outcome|IDMEAC|Intra-operative assessment of Octafibrin efficacy in surgical prophylaxis as assessed by the IDMEAC.
11230796|NCT02408484|OG000|Outcome|Prothrombin Fragments (1+2)|Patients with elevated values of prothrombin Fragments 1+2 (outside of the reference range of 69 to 229 pmol/L) 3 hours post-infusion
11230797|NCT02408484|OG000|Outcome|Octafibrin|The safety population consists of all patients that met the inclusion criteria and received at least one infusion of Octafibrin (n=14)
11230798|NCT02408484|EG000|Reported Event|Octafibrin|The safety population consists of all patients that met the inclusion criteria and received at least one infusion of Octafibrin (n=14)
11230799|NCT02408523|BG000|Baseline|Placebo|"Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants >= 50 kg.~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg).~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg)."
11230800|NCT02408523|BG001|Baseline|Lacosamide|"Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg).~Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg).~Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg)."
11230801|NCT02408523|BG002|Baseline|Total Title|
11230802|NCT02408523|FG000|Participant Flow|Placebo|"Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants >= 50 kg.~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg).~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg)."
11230803|NCT02408523|FG001|Participant Flow|Lacosamide|"Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg).~Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg).~Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg)."
11167360|NCT01978314|EG001|Reported Event|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD
11167361|NCT01978314|EG002|Reported Event|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD
11167362|NCT01978314|EG003|Reported Event|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI
11167363|NCT01978314|EG004|Reported Event|Cohort 5|eGFR renal function ≥60 mL/min for normal function
11167364|NCT01978509|BG000|Baseline|Low Volume Prep (Prepopik)|"Low volume prep for colonoscopy (Prepopik)~Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167365|NCT01978509|BG001|Baseline|Moderate Volume Prep (Moviprep)|"Moderate volume prep for colonoscopy (Moviprep)~Moderate volume prep (Moviprep): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167366|NCT01978509|BG002|Baseline|High Volume Prep (Golytely)|"High volume prep for colonoscopy (Golytely)~High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167367|NCT01978509|BG003|Baseline|Total|Total of all reporting groups
11167368|NCT01978509|FG000|Participant Flow|Low Volume Prep (Prepopik)|"Low volume prep for colonoscopy (Prepopik)~Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167369|NCT01978509|FG001|Participant Flow|Moderate Volume Prep (Moviprep)|"Moderate volume prep for colonoscopy (Moviprep)~Moderate volume prep (Moviprep): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167370|NCT01978509|FG002|Participant Flow|High Volume Prep (Golytely)|"High volume prep for colonoscopy (Golytely)~High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167371|NCT01978509|OG000|Outcome|Low Volume Prep (Prepopik)|"Low volume prep for colonoscopy (Prepopik)~Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167372|NCT01978509|OG001|Outcome|Moderate Volume Prep (Moviprep)|"Moderate volume prep for colonoscopy (Moviprep)~Moderate volume prep (Moviprep): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167373|NCT01978509|OG002|Outcome|High Volume Prep (Golytely)|"High volume prep for colonoscopy (Golytely)~High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167374|NCT01978509|EG000|Reported Event|Low Volume Prep (Prepopik)|"Low volume prep for colonoscopy (Prepopik)~Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167375|NCT01978509|EG001|Reported Event|Moderate Volume Prep (Moviprep)|"Moderate volume prep for colonoscopy (Moviprep)~Moderate volume prep (Moviprep): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167376|NCT01978509|EG002|Reported Event|High Volume Prep (Golytely)|"High volume prep for colonoscopy (Golytely)~High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy."
11167377|NCT01978600|BG000|Baseline|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
11167378|NCT01978600|BG001|Baseline|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
11167379|NCT01978600|BG002|Baseline|Total|Total of all reporting groups
11167380|NCT01978600|FG000|Participant Flow|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
11167381|NCT01978600|FG001|Participant Flow|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
11167382|NCT01978600|OG000|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
11167383|NCT01978600|OG001|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
11167384|NCT01978600|EG000|Reported Event|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
11167385|NCT01978600|EG001|Reported Event|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
11167386|NCT01978743|BG000|Baseline|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
11167387|NCT01978743|FG000|Participant Flow|Raltegravir|"All participants are switched from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + truvada (FTC/TDF).~Raltegravir will be administered 400mg twice-a-day."
11167388|NCT01978743|OG000|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.~Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
11167389|NCT01978743|OG000|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
11089432|NCT01523808|BG003|Baseline|GRASPA 150|"Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11230804|NCT02408523|OG000|Outcome|Placebo (FAS)|"Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg.~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg).~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).~Participants formed the Full Analysis Set (FAS)."
11230805|NCT02408523|OG001|Outcome|Lacosamide (FAS)|"Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg).~Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg).~Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).~Participants formed the FAS."
11230806|NCT02408523|OG000|Outcome|Placebo (SS)|"Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg.~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg).~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).~Participants formed the Safety Set (SS)."
11230807|NCT02408523|OG001|Outcome|Lacosamide (SS)|"Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg).~Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg).~Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).~Participants formed the SS."
10887894|NCT00503750|FG000|Participant Flow|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
10887895|NCT00503750|OG000|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
10887896|NCT00503750|EG000|Reported Event|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
10887897|NCT00503776|BG000|Baseline|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
10887898|NCT00503776|BG001|Baseline|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
10887899|NCT00503776|BG002|Baseline|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
10887900|NCT00503776|BG003|Baseline|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
10887901|NCT00503776|BG004|Baseline|Total|Total of all reporting groups
10887902|NCT00503776|FG000|Participant Flow|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
10887903|NCT00503776|FG001|Participant Flow|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
11089433|NCT01523808|BG004|Baseline|Total|Total of all reporting groups
11352384|NCT03951805|BG002|Baseline|Insulin 287 (Titration Algorithm C)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 U. The dose was adjusted weekly during the treatment period using titration algorithm C with glycaemic target of 3.9-6.0 mmol/L (70-108 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 3.9 mmol/L: insulin dose reduced by 28 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 3.9-6.0 mmol/L: no adjustment; > 6.0 mmol/L: insulin dose increased by 28 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352385|NCT03951805|BG003|Baseline|Insulin Glargine (Titration Algorithm D)|Subjects were to receive once daily s.c. injection of Insulin glargine for 16 weeks, using SoloSTAR pre-filled pen-injector at a starting dose of 10 U. The dose was adjusted weekly during the treatment period using titration algorithm D with ADA glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 4 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 4 U. All subjects used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352386|NCT03951805|BG004|Baseline|Total|Total of all reporting groups
11352387|NCT03951805|FG000|Participant Flow|Insulin 287 (Titration Algorithm A)|Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 units (U). The dose was adjusted weekly during the treatment period using titration algorithm A with American Diabetes Association (ADA) glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 21 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 21 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352388|NCT03951805|FG001|Participant Flow|Insulin 287 (Titration Algorithm B)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 U. The dose was adjusted weekly during the treatment period using titration algorithm B with ADA glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 28 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 28 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication
11352389|NCT03951805|FG002|Participant Flow|Insulin 287 (Titration Algorithm C)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 U. The dose was adjusted weekly during the treatment period using titration algorithm C with glycaemic target of 3.9-6.0 mmol/L (70-108 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 3.9 mmol/L: insulin dose reduced by 28 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 3.9-6.0 mmol/L: no adjustment; > 6.0 mmol/L: insulin dose increased by 28 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352390|NCT03951805|FG003|Participant Flow|Insulin Glargine (Titration Algorithm D)|Subjects were to receive once daily s.c. injection of Insulin glargine for 16 weeks, using SoloSTAR pre-filled pen-injector at a starting dose of 10 U. The dose was adjusted weekly during the treatment period using titration algorithm D with ADA glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 4 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 4 U. All subjects used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352391|NCT03951805|OG000|Outcome|Insulin 287 (Titration Algorithm A)|Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 units (U). The dose was adjusted weekly during the treatment period using titration algorithm A with American Diabetes Association (ADA) glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 21 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 21 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
10887904|NCT00503776|FG002|Participant Flow|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
11352392|NCT03951805|OG001|Outcome|Insulin 287 (Titration Algorithm B)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 U. The dose was adjusted weekly during the treatment period using titration algorithm B with ADA glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 28 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 28 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication
11352393|NCT03951805|OG002|Outcome|Insulin 287 (Titration Algorithm C)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 U. The dose was adjusted weekly during the treatment period using titration algorithm C with glycaemic target of 3.9-6.0 mmol/L (70-108 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 3.9 mmol/L: insulin dose reduced by 28 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 3.9-6.0 mmol/L: no adjustment; > 6.0 mmol/L: insulin dose increased by 28 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352394|NCT03951805|OG003|Outcome|Insulin Glargine (Titration Algorithm D)|Subjects were to receive once daily s.c. injection of Insulin glargine for 16 weeks, using SoloSTAR pre-filled pen-injector at a starting dose of 10 U. The dose was adjusted weekly during the treatment period using titration algorithm D with ADA glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 4 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 4 U. All subjects used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352395|NCT03951805|EG000|Reported Event|Insulin 287 (Titration Algorithm A)|Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 units (U). The dose was adjusted weekly during the treatment period using titration algorithm A with American Diabetes Association (ADA) glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 21 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 21 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352396|NCT03951805|EG001|Reported Event|Insulin 287 (Titration Algorithm B)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 U. The dose was adjusted weekly during the treatment period using titration algorithm B with ADA glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 28 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 28 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication
11352397|NCT03951805|EG002|Reported Event|Insulin 287 (Titration Algorithm C)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 70 U. The dose was adjusted weekly during the treatment period using titration algorithm C with glycaemic target of 3.9-6.0 mmol/L (70-108 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 3.9 mmol/L: insulin dose reduced by 28 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 3.9-6.0 mmol/L: no adjustment; > 6.0 mmol/L: insulin dose increased by 28 U. All participants used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
10887905|NCT00503776|FG003|Participant Flow|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
10887906|NCT00503776|OG000|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
10887907|NCT00503776|OG001|Outcome|Arm IB|Patients undergo SNT and low-weight resistance training (LWRT).
10887908|NCT00503776|OG002|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
10887909|NCT00503776|OG003|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
10887910|NCT00503776|OG001|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
11167390|NCT01978743|EG000|Reported Event|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
11167391|NCT01978912|BG000|Baseline|Cohort 1 KTP-001 5 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167392|NCT01978912|BG001|Baseline|Cohort 2 KTP-001 15 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167393|NCT01978912|BG002|Baseline|Cohort 3 KTP-001 50 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167394|NCT01978912|BG003|Baseline|Cohort 4 KTP-001 150 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167395|NCT01978912|BG004|Baseline|Total|Total of all reporting groups
11167396|NCT01978912|FG000|Participant Flow|Cohort 1 KTP-001 5 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167397|NCT01978912|FG001|Participant Flow|Cohort 2 KTP-001 15 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167398|NCT01978912|FG002|Participant Flow|Cohort 3 KTP-001 50 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167399|NCT01978912|FG003|Participant Flow|Cohort 4 KTP-001 150 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167400|NCT01978912|OG000|Outcome|Cohort 1 KTP-001 5 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167401|NCT01978912|OG001|Outcome|Cohort 2 KTP-001 15 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167402|NCT01978912|OG002|Outcome|Cohort 3 KTP-001 50 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167403|NCT01978912|OG003|Outcome|Cohort 4 KTP-001 150 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167404|NCT01978912|EG000|Reported Event|Cohort 1 KTP-001 5 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167405|NCT01978912|EG001|Reported Event|Cohort 2 KTP-001 15 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167406|NCT01978912|EG002|Reported Event|Cohort 3 KTP-001 50 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167407|NCT01978912|EG003|Reported Event|Cohort 4 KTP-001 150 μg/Disc|KTP-001: KTP-001 is one time dose intradiscally.
11167408|NCT01979016|BG000|Baseline|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11167409|NCT01979016|BG001|Baseline|Dupilumab 200 mg qw|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
11167410|NCT01979016|BG002|Baseline|Total|Total of all reporting groups
11167411|NCT01979016|FG000|Participant Flow|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11167412|NCT01979016|FG001|Participant Flow|Dupilumab 200 mg qw|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
11167413|NCT01979016|OG000|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11167414|NCT01979016|OG001|Outcome|Dupilumab 200 mg qw|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
11167415|NCT01979016|EG000|Reported Event|Placebo qw|Participants exposed to Placebo (for Dupilumab) (mean exposure of 10 weeks).
11167416|NCT01979016|EG001|Reported Event|Dupilumab 200 mg qw|Participants exposed to Dupilumab 200 mg qw (mean exposure of 14 weeks).
11167417|NCT01979029|BG000|Baseline|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
11167418|NCT01979029|BG001|Baseline|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
11167419|NCT01979029|BG002|Baseline|Total|Total of all reporting groups
11167420|NCT01979029|FG000|Participant Flow|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
11167421|NCT01979029|FG001|Participant Flow|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
11352398|NCT03951805|EG003|Reported Event|Insulin Glargine (Titration Algorithm D)|Subjects were to receive once daily s.c. injection of Insulin glargine for 16 weeks, using SoloSTAR pre-filled pen-injector at a starting dose of 10 U. The dose was adjusted weekly during the treatment period using titration algorithm D with ADA glycaemic target of 4.4-7.2 mmol/L (80-130 mg/dL), based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: insulin dose reduced by 4 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was between 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 4 U. All subjects used metformin with or without DPP4i and with or without SGLT2i at the stable, pre-trial dose and at the same frequency during the entire treatment period unless due to safety concerns related to the background medication.
11352399|NCT03944785|BG000|Baseline|DA Switchers|Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
11089434|NCT01523808|FG000|Participant Flow|GRASPA 25|GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
11089435|NCT01523808|FG001|Participant Flow|GRASPA 50|GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
11089436|NCT01523808|FG002|Participant Flow|GRASPA 100|GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
11089437|NCT01523808|FG003|Participant Flow|GRASPA 150|GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
11089438|NCT01523808|OG000|Outcome|GRASPA 25|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11089439|NCT01523808|OG001|Outcome|GRASPA 50|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 3 subjects completed"
11089440|NCT01523808|OG002|Outcome|GRASPA 100|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 1 subject completed"
11089441|NCT01523808|OG003|Outcome|GRASPA 150|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11089442|NCT01523808|OG000|Outcome|GRASPA 25|"Participants received one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11089443|NCT01523808|OG001|Outcome|GRASPA 50|"Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose~3 subjects enrolled; 3 subjects completed"
11089444|NCT01523808|OG002|Outcome|GRASPA 100|"Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose~3 subjects enrolled; 1 subject completed"
11089445|NCT01523808|OG003|Outcome|GRASPA 150|"Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11089446|NCT01523808|OG001|Outcome|GRASPA 150|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11089447|NCT01523808|OG000|Outcome|GRASPA 25|GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
11089448|NCT01523808|OG001|Outcome|GRASPA 50|GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
11089449|NCT01523808|OG002|Outcome|GRASPA 100|GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
11089450|NCT01523808|OG003|Outcome|GRASPA 150|GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
11089451|NCT01523808|EG000|Reported Event|GRASPA 25|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11089452|NCT01523808|EG001|Reported Event|GRASPA 50|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 3 subjects completed"
11089453|NCT01523808|EG002|Reported Event|GRASPA 100|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 1 subject completed"
11089454|NCT01523808|EG003|Reported Event|GRASPA 150|"GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose~3 subjects enrolled; 0 subjects completed"
11352400|NCT03944785|BG001|Baseline|MAO-B|Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
11352401|NCT03944785|BG002|Baseline|MAO-B Naive|Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
11352402|NCT03944785|BG003|Baseline|Total|Total of all reporting groups
11352403|NCT03944785|FG000|Participant Flow|DA Switchers|Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
11352404|NCT03944785|FG001|Participant Flow|MAO-B Switchers|Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
11352405|NCT03944785|FG002|Participant Flow|MAO-B Naive|Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
11352406|NCT03944785|OG000|Outcome|DA Switchers|Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
11352407|NCT03944785|OG001|Outcome|MAO-B Switchers|Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
11352408|NCT03944785|OG002|Outcome|MAO-B Naive|Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
11352409|NCT03944785|EG000|Reported Event|DA Switchers|Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
11352410|NCT03944785|EG001|Reported Event|MAO-B Switchers|Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
11352411|NCT03944785|EG002|Reported Event|MAO-B Naive|Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
11352412|NCT03950622|BG000|Baseline|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
11352413|NCT03950622|BG001|Baseline|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
11352414|NCT03950622|BG002|Baseline|Total|Total of all reporting groups
11352415|NCT03950622|FG000|Participant Flow|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
11352416|NCT03950622|FG001|Participant Flow|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
11352417|NCT03950622|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
11352418|NCT03950622|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
11352419|NCT03950622|EG000|Reported Event|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
11352420|NCT03950622|EG001|Reported Event|PCV13|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
11352421|NCT03949621|BG000|Baseline|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.
11352422|NCT03949621|BG001|Baseline|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352423|NCT03949621|BG002|Baseline|Total|Total of all reporting groups
11352424|NCT03949621|FG000|Participant Flow|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.
11352425|NCT03949621|FG001|Participant Flow|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352426|NCT03949621|OG000|Outcome|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.
11352427|NCT03949621|OG001|Outcome|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352428|NCT03949621|EG000|Reported Event|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.
11352429|NCT03949621|EG001|Reported Event|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352430|NCT03949244|BG000|Baseline|Latanoprost 0.005%|"Latanoprost 0.005% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired.~Nailfold capillaroscopy: An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger."
11352431|NCT03949244|BG001|Baseline|Latanoprost Bunod 0.024%|Latanoprost bunod 0.024% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
11352432|NCT03949244|BG002|Baseline|Normal Saline 0.9%|Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
11352433|NCT03949244|BG003|Baseline|Total|Total of all reporting groups
11352434|NCT03949244|FG000|Participant Flow|Latanoprost 0.005%|"Latanoprost 0.005% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired.~Nailfold capillaroscopy: An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger."
11352435|NCT03949244|FG001|Participant Flow|Latanoprost Bunod 0.024%|Latanoprost bunod 0.024% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
11352436|NCT03949244|FG002|Participant Flow|Normal Saline 0.9%|Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
11352437|NCT03949244|OG000|Outcome|Latanoprost 0.005%|"Latanoprost 0.005% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired.~Nailfold capillaroscopy: An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger."
11352438|NCT03949244|OG001|Outcome|Latanoprost Bunod 0.024%|Latanoprost bunod 0.024% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
11352439|NCT03949244|OG002|Outcome|Normal Saline 0.9%|Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
11167422|NCT01979029|OG000|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
11335536|NCT03552289|FG001|Participant Flow|Conventional Angioplasty Balloon Catheters|"Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.~Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula"
11335537|NCT03552289|OG000|Outcome|Cook Enforcer Balloon Catheter|"The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.~Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula"
11335538|NCT03552289|OG001|Outcome|Conventional Angioplasty Balloon Catheters|"Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.~Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula"
11335539|NCT03552289|EG000|Reported Event|Cook Enforcer Balloon Catheter|"The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.~Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula"
11335540|NCT03552289|EG001|Reported Event|Conventional Angioplasty Balloon Catheters|"Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.~Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula"
11335541|NCT03552523|BG000|Baseline|All Enrolled Subjects|All enrolled subjects
11335542|NCT03552523|FG000|Participant Flow|Usual Care First Then Bionic Pancreas|"Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.~Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter."
11335543|NCT03552523|FG001|Participant Flow|Bionic Pancreas First Then Usual Care|"Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.~Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections."
11335544|NCT03552523|OG000|Outcome|Usual Care|"Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.~Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections."
11335545|NCT03552523|OG001|Outcome|Bionic Pancreas|"During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.~Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter."
11335546|NCT03552523|EG000|Reported Event|Bionic Pancreas|Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.
11335547|NCT03552523|EG001|Reported Event|Usual Care|Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.
11335548|NCT03552536|BG000|Baseline|A: MK-8583 100mg|After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
11335549|NCT03552536|BG001|Baseline|B: MK-8583 ≤ 150 mg|After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.
11335550|NCT03552536|BG002|Baseline|C: MK-8583 ≤ 150 mg|After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.
11335551|NCT03552536|BG003|Baseline|Total|Total of all reporting groups
11335552|NCT03552536|FG000|Participant Flow|A: MK-8583 100mg|After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
11335553|NCT03552536|FG001|Participant Flow|B: MK-8583 ≤ 150 mg|After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.
11335554|NCT03552536|FG002|Participant Flow|C: MK-8583 ≤ 150 mg|After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.
11335555|NCT03552536|OG000|Outcome|A: MK-8583 100mg|After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
11335556|NCT03552536|EG000|Reported Event|MK-8583 100 mg|After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
11335557|NCT03552536|EG001|Reported Event|B: MK-8583 ≤ 150 mg|After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.
11335558|NCT03552536|EG002|Reported Event|C: MK-8583 ≤ 150 mg|After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.
11167423|NCT01979029|OG001|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
11167424|NCT01979029|EG000|Reported Event|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
11167425|NCT01979029|EG001|Reported Event|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
11167426|NCT01979133|BG000|Baseline|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
11167427|NCT01979133|FG000|Participant Flow|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
11167428|NCT01979133|OG000|Outcome|Baseline|Baseline HAMD Score
11167429|NCT01979133|OG001|Outcome|Week 8|Week 8 HAMD Score
11167430|NCT01979133|OG000|Outcome|Baseline|Baseline HAMA Score
11167431|NCT01979133|OG001|Outcome|Week 8|Week 8 HAMA Score
11167432|NCT01979133|OG000|Outcome|Baseline|Baseline QIDS Score
11167433|NCT01979133|OG001|Outcome|Week 8|Week 8 QIDS Score
11167434|NCT01979133|OG000|Outcome|Baseline|Baseline Mean Standard Drinks Per Week
11167435|NCT01979133|OG001|Outcome|Week 8|Week 8 Mean Standard Drinks Per Week
11167436|NCT01979133|OG000|Outcome|Baseline|Baseline Heavy Drinking Days Per Week
11167437|NCT01979133|OG001|Outcome|Week 8|Week 8 Heavy Drinking Days Per Week
11167438|NCT01979133|OG000|Outcome|Baseline|Baseline Days of alcohol use per week
11167439|NCT01979133|OG001|Outcome|Week 8|Week 8 Days of alcohol use per week
11167440|NCT01979133|OG000|Outcome|Baseline|Baseline YMRS Score
11167441|NCT01979133|OG001|Outcome|Week 8|Week 8 YMRS Score
11167442|NCT01979133|EG000|Reported Event|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
11167443|NCT01979159|BG000|Baseline|Combined Aphasia and Apraxia of Speech Treatment (CAAST)|Speakers with chronic aphasia and apraxia of speech who received the experimental treatment
11167444|NCT01979159|FG000|Participant Flow|Combined Aphasia and Apraxia of Speech Treatment (CAAST)|"CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs~Combined Aphasia and Apraxia of Speech Treatment (CAAST): Therapy is delivered in a face-to-face format. The therapist uses picture stimuli, verbal modeling, feedback, reinforcement, forward-chaining to increase verbal production. For speech errors that occur, the therapist uses modeling, feedback, reinforcement, simultaneous production, articulatory instruction, and repeated practice to improve articulation."
11352440|NCT03949244|EG000|Reported Event|Latanoprost 0.005%|"Latanoprost 0.005% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired.~Nailfold capillaroscopy: An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger."
11352441|NCT03949244|EG001|Reported Event|Latanoprost Bunod 0.024%|Latanoprost bunod 0.024% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
11352442|NCT03949244|EG002|Reported Event|Normal Saline 0.9%|Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
11352443|NCT03948581|BG000|Baseline|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352444|NCT03948581|BG001|Baseline|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352445|NCT03948581|BG002|Baseline|Total|Total of all reporting groups
11167445|NCT01979159|OG000|Outcome|Combined Aphasia and Apraxia of Speech Treatment (CAAST)|CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs.
11167446|NCT01979159|OG000|Outcome|Combined Aphasia and Apraxia of Speech Treatment (CAAST)|CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs
11167447|NCT01979159|OG000|Outcome|Combined Aphasia and Apraxia of Speech Treatment (CAAST)|CAAST was administered to 4 persons with chronic aphasia and apraxia of speech in the context of single-subject designs
11352446|NCT03948581|FG000|Participant Flow|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352447|NCT03948581|FG001|Participant Flow|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352448|NCT03948581|OG000|Outcome|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352449|NCT03948581|OG001|Outcome|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352450|NCT03948581|EG000|Reported Event|Group A: Vedolizumab SC PFS|Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
11352451|NCT03948581|EG001|Reported Event|Group B: Vedolizumab SC Investigational Device|Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
11352452|NCT03948386|BG000|Baseline|Isobaric Bupivacaine|"Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74 height and 15 mg (3 cc) for > 74 height~isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352453|NCT03948386|BG001|Baseline|Hyperbaric Bupivacaine|"hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74 height and 13.125 mg (1.75 cc) for > 74 height~hyperbaric bupivacaine: TThe anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352454|NCT03948386|BG002|Baseline|Isobaric Mepivacaine|"isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74 height and 60 mg (4 cc) for > 74 height~isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352455|NCT03948386|BG003|Baseline|Total|Total of all reporting groups
11352456|NCT03948386|FG000|Participant Flow|Isobaric Bupivacaine|"Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74 height and 15 mg (3 cc) for > 74 height~isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11167448|NCT01979159|EG000|Reported Event|Combined Aphasia and Apraxia of Speech Treatment (CAAST)|"Administration of CAAST to 4 persons with aphasia and apraxia of speech in the context of single-subject designs~Combined Aphasia and Apraxia of Speech Treatment (CAAST): Therapy is delivered in a face-to-face format. The therapist uses picture stimuli, verbal modeling, feedback, reinforcement, forward-chaining to increase verbal production. For speech errors that occur, the therapist uses modeling, feedback, reinforcement, simultaneous production, articulatory instruction, and repeated practice to improve articulation."
11352457|NCT03948386|FG001|Participant Flow|Hyperbaric Bupivacaine|"hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74 height and 13.125 mg (1.75 cc) for > 74 height~hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11167449|NCT01979185|BG000|Baseline|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
11167450|NCT01979185|BG001|Baseline|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
11167451|NCT01979185|BG002|Baseline|Total|Total of all reporting groups
11167452|NCT01979185|FG000|Participant Flow|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
11352458|NCT03948386|FG002|Participant Flow|Isobaric Mepivacaine|"isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74 height and 60 mg (4 cc) for > 74 height~isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352459|NCT03948386|OG000|Outcome|Isobaric Bupivacaine|"Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74 height and 15 mg (3 cc) for > 74 height~isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352460|NCT03948386|OG001|Outcome|Hyperbaric Bupivacaine|"hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74 height and 13.125 mg (1.75 cc) for > 74 height~hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352461|NCT03948386|OG002|Outcome|Isobaric Mepivacaine|"isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74 height and 60 mg (4 cc) for > 74 height~isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352462|NCT03948386|EG000|Reported Event|Isobaric Bupivacaine|"Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74 height and 15 mg (3 cc) for > 74 height~isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352463|NCT03948386|EG001|Reported Event|Hyperbaric Bupivacaine|"hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74 height and 13.125 mg (1.75 cc) for > 74 height~hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352464|NCT03948386|EG002|Reported Event|Isobaric Mepivacaine|"isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74 height and 60 mg (4 cc) for > 74 height~isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic."
11352465|NCT03948334|BG000|Baseline|ZPL389 30mg|Dose 1 of ZPL389 + TCS and/or TCI
11352466|NCT03948334|BG001|Baseline|ZPL389 50mg|Dose 2 of ZPL389 + TCS and/or TCI
11352467|NCT03948334|BG002|Baseline|Total|Total of all reporting groups
11352468|NCT03948334|FG000|Participant Flow|ZPL389 30mg|Dose 1 of ZPL389 + TCS and/or TCI
11352469|NCT03948334|FG001|Participant Flow|ZPL389 50mg|Dose 2 of ZPL389 + TCS and/or TCI
11352470|NCT03948334|OG000|Outcome|ZPL389 30mg|Dose 1 of ZPL389 + TCS and/or TCI
11352471|NCT03948334|OG001|Outcome|ZPL389 50mg|Dose 2 of ZPL389 + TCS and/or TCI
11352472|NCT03948334|OG000|Outcome|ZPL389 30mg|30mg of ZPL389 + TCS and/or TCI
11352473|NCT03948334|OG001|Outcome|ZPL389 50mg|50mg of ZPL389 + TCS and/or TCI
11352474|NCT03948334|OG000|Outcome|ZPL389 30mg Re-randomized After Core Study|30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study)
11352475|NCT03948334|OG001|Outcome|ZPL389 50mg Re-randomized After Core Study|50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study)
11352476|NCT03948334|OG002|Outcome|ZPL389 30mg Continuing After Core Study|30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
11352477|NCT03948334|OG003|Outcome|ZPL389 50mg Continuing After Core Study|50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study
11352478|NCT03948334|EG000|Reported Event|ZPL389 30mg in the First 16 Weeks of This Extension Study|AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study)
11352479|NCT03948334|EG001|Reported Event|ZPL389 50mg in the First 16 Weeks of This Extension Study|AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study)
11352480|NCT03948334|EG002|Reported Event|ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study|AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)
11352481|NCT03948334|EG003|Reported Event|ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study|AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)
11352482|NCT03946059|BG000|Baseline|cTBS Then iTBS|Participants received cTBS at week 1 (1 day), washout (1 week) then iTBS at week 2 (1 day).
11352483|NCT03946059|BG001|Baseline|iTBS Then cTBS|Participants received iTBS at week 1 (1 day), washout (1 week) then cTBS at week 2 (1 day).
11352484|NCT03946059|BG002|Baseline|Total|Total of all reporting groups
11352485|NCT03946059|FG000|Participant Flow|cTBS Then iTBS|Participants received cTBS at week 1 (1 day), washout (1 week) then iTBS at week 2 (1 day). The global cognitive task-average superior frontal theta signal was calculated as (Post - Pre)cTBS versus (Post-Pre)iTBS
11352486|NCT03946059|FG001|Participant Flow|iTBS Then cTBS|Participants received iTBS at week 1 (1 day), washout (1 week) then cTBS at week 2 (1 day). The global cognitive task-average superior frontal theta signal was calculated as (Post - Pre)iTBS versus (Post-Pre)cTBS
11352487|NCT03946059|OG000|Outcome|cTBS|Participants received cTBS intervention in one of the two study visits. The global cognitive task-average FCz theta signal was calculated as (Post-Pre)cTBS.
11352488|NCT03946059|OG001|Outcome|iTBS|The participants received iTBS intervention in one of the two study visits. The global cognitive task-average FCz theta signal was calculated as (Post-Pre)iTBS.
11352489|NCT03946059|OG000|Outcome|cTBS|Participants received cTBS intervention in one of the two study visits. The global cognitive performance was averaged across all cognitive tasks to yield global cognitive task-averaged performance that was measured immediately before (Pre) and immediately after (Post) cTBS, presented here as Post-Pre in log per second.
11352490|NCT03946059|OG001|Outcome|iTBS|Participants received iTBS intervention in one of the two study visits. The global cognitive performance was averaged across all cognitive tasks to yield global cognitive task-averaged performance that was measured immediately before (Pre) and immediately after (Post) iTBS, presented here as Post-Pre in log per second.
11352491|NCT03946059|EG000|Reported Event|cTBS|Participants received cTBS intervention in one of the two study visits.
11352492|NCT03946059|EG001|Reported Event|iTBS|Participants received iTBS intervention in one of the two study visits.
11352493|NCT03944707|BG000|Baseline|LOU064|LOU064 100 mg once daily orally
11352494|NCT03944707|BG001|Baseline|Placebo|Placebo once daily orally
11352495|NCT03944707|BG002|Baseline|Total|Total of all reporting groups
11352496|NCT03944707|FG000|Participant Flow|LOU064|LOU064 100 mg once daily orally
11352497|NCT03944707|FG001|Participant Flow|Placebo|Placebo once daily orally
11352498|NCT03944707|OG000|Outcome|LOU064|LOU064 100 mg once daily orally
11352499|NCT03944707|OG001|Outcome|Placebo|Placebo once daily orally
11352500|NCT03944707|EG000|Reported Event|LOU064|LOU064 100 mg once daily orally
11352501|NCT03944707|EG001|Reported Event|Placebo|Placebo once daily orally
11352502|NCT03944668|BG000|Baseline|Intervention|"Exercise intervention~Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks"
11352503|NCT03944668|FG000|Participant Flow|Intervention|"Exercise intervention~Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks"
11352504|NCT03944668|OG000|Outcome|Intervention|"Exercise intervention~Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks"
11352505|NCT03944668|OG000|Outcome|Intervention|Stroke patients enrolled in study
11352506|NCT03944668|EG000|Reported Event|Intervention|Stroke patients enrolled in study
11352507|NCT03943160|BG000|Baseline|OAS Use Via Transradial Access (TRA)|All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
11352508|NCT03943160|FG000|Participant Flow|OAS Use Via Transradial Access (TRA)|All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
11352509|NCT03943160|OG000|Outcome|OAS Use Via Transradial Access (TRA)|All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
11352510|NCT03943160|EG000|Reported Event|OAS Use Via Transradial Access (TRA)|All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
11352511|NCT03943095|BG000|Baseline|Test Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants received test dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
11352512|NCT03943095|BG001|Baseline|Control Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing. Participants received control dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
11352513|NCT03943095|BG002|Baseline|Total|Total of all reporting groups
11352514|NCT03943095|FG000|Participant Flow|Test Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants received test dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
11352515|NCT03943095|FG001|Participant Flow|Control Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing. Participants received control dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
11352516|NCT03943095|OG000|Outcome|Test Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
11352517|NCT03943095|OG001|Outcome|Control Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
11352518|NCT03943095|OG000|Outcome|Test Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
11352519|NCT03943095|EG000|Reported Event|Test Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants received test dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
11352520|NCT03943095|EG001|Reported Event|Control Dentifrice|Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing. Participants received control dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
11352521|NCT03943290|BG000|Baseline|Part 1 Cohort 1a|"ACE-083 240 mg/muscle administered bilaterally by injection into the TA muscle every 4 weeks for up to 6 doses for FSHD patients~ACE-083: Recombinant fusion protein"
11352522|NCT03943290|BG001|Baseline|Part 1 Cohort 1b|"ACE-083 240 mg/muscle administered bilaterally by injection into the BB muscle every 4 weeks for up to 6 doses for FSHD patients~ACE-083: Recombinant fusion protein"
11352523|NCT03943290|BG002|Baseline|Part 1 Cohort 1c|"ACE-083 240 mg/muscle administered bilaterally by injection into the TA muscle every 4 weeks for up to 6 doses for CMT patients~ACE-083: Recombinant fusion protein"
11352524|NCT03943290|BG003|Baseline|Part 2 Cohort 2a|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352525|NCT03943290|BG004|Baseline|Part 2 Cohort 2b|"ACE-083 Administered into the BB muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352526|NCT03943290|BG005|Baseline|Part 2 Cohort 2c|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352527|NCT03943290|BG006|Baseline|Part 2 Cohort 3a|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352528|NCT03943290|BG007|Baseline|Part 2 Cohort 3b|"ACE-083 Administered into the BB muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352529|NCT03943290|BG008|Baseline|Part 2 Cohort 3c|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352530|NCT03943290|BG009|Baseline|Total|Total of all reporting groups
11352531|NCT03943290|FG000|Participant Flow|Part 1 Cohort 1a|"ACE-083 240 mg/muscle administered bilaterally by injection into the TA muscle every 4 weeks for up to 6 doses for FSHD patients~ACE-083: Recombinant fusion protein"
11352532|NCT03943290|FG001|Participant Flow|Part 1 Cohort 1b|"ACE-083 240 mg/muscle administered bilaterally by injection into the BB muscle every 4 weeks for up to 6 doses for FSHD patients~ACE-083: Recombinant fusion protein"
11352533|NCT03943290|FG002|Participant Flow|Part 1 Cohort 1c|"ACE-083 240 mg/muscle administered bilaterally by injection into the TA muscle every 4 weeks for up to 6 doses for CMT patients~ACE-083: Recombinant fusion protein"
11352534|NCT03943290|FG003|Participant Flow|Part 2 Cohort 2a|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352535|NCT03943290|FG004|Participant Flow|Part 2 Cohort 2b|"ACE-083 Administered into the BB muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352536|NCT03943290|FG005|Participant Flow|Part 2 Cohort 2c|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352537|NCT03943290|FG006|Participant Flow|Part 2 Cohort 3a|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352538|NCT03943290|FG007|Participant Flow|Part 2 Cohort 3b|"ACE-083 Administered into the BB muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352539|NCT03943290|FG008|Participant Flow|Part 2 Cohort 3c|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352540|NCT03943290|OG000|Outcome|Part 2 Cohort 2a|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352541|NCT03943290|OG001|Outcome|Part 2 Cohort 2b|"ACE-083 Administered into the BB muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352542|NCT03943290|OG002|Outcome|Part 2 Cohort 2c|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352543|NCT03943290|OG003|Outcome|Part 2 Cohort 3a|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352544|NCT03943290|OG004|Outcome|Part 2 Cohort 3b|"ACE-083 Administered into the BB muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352545|NCT03943290|OG005|Outcome|Part 2 Cohort 3c|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352546|NCT03943290|OG000|Outcome|Part 2 Cohort 2b|"ACE-083 Administered into the BB muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352547|NCT03943290|OG001|Outcome|Part 2 Cohort 2c|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352548|NCT03943290|OG002|Outcome|Part 2 Cohort 3b|"ACE-083 Administered into the BB muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352549|NCT03943290|OG003|Outcome|Part 2 Cohort 3c|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352550|NCT03943290|OG000|Outcome|Part 2 Cohort 2a|ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for FSHD patients ACE-083: Recombinant fusion protein
11352551|NCT03943290|OG002|Outcome|Part 2 Cohort 3a|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352552|NCT03943290|OG002|Outcome|Part 2 Cohort 3c|ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for FSHD patients ACE-083: Recombinant fusion protein
11352553|NCT03943290|OG001|Outcome|Part 2 Cohort 3a|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352554|NCT03943290|OG001|Outcome|Part 2 Cohort 3b|"ACE-083 Administered into the BB muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352555|NCT03943290|OG000|Outcome|Part 2 Cohort 3b|"ACE-083 Administered into the BB muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352556|NCT03943290|OG003|Outcome|Part 2 Cohort 3b|"ACE-083 Administered into the BB muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352557|NCT03943290|OG000|Outcome|Part 2 Cohort 2c|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352558|NCT03943290|OG001|Outcome|Part 2 Cohort 3c|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352559|NCT03943290|OG000|Outcome|Part 1 Cohort 1a|"ACE-083 240 mg/muscle administered bilaterally by injection into the TA muscle every 4 weeks for up to 6 doses for FSHD patients~ACE-083: Recombinant fusion protein"
11352560|NCT03943290|OG001|Outcome|Part 1 Cohort 1b|"ACE-083 240 mg/muscle administered bilaterally by injection into the BB muscle every 4 weeks for up to 6 doses for FSHD patients~ACE-083: Recombinant fusion protein"
11352561|NCT03943290|OG002|Outcome|Part 1 Cohort 1c|"ACE-083 240 mg/muscle administered bilaterally by injection into the TA muscle every 4 weeks for up to 6 doses for CMT patients~ACE-083: Recombinant fusion protein"
11352562|NCT03943290|EG000|Reported Event|Part 1 Cohort 1a|"ACE-083 240 mg/muscle administered bilaterally by injection into the TA muscle every 4 weeks for up to 6 doses for FSHD patients~ACE-083: Recombinant fusion protein"
11352563|NCT03943290|EG001|Reported Event|Part 1 Cohort 1b|"ACE-083 240 mg/muscle administered bilaterally by injection into the BB muscle every 4 weeks for up to 6 doses for FSHD patients~ACE-083: Recombinant fusion protein"
11352564|NCT03943290|EG002|Reported Event|Part 1 Cohort 1c|"ACE-083 240 mg/muscle administered bilaterally by injection into the TA muscle every 4 weeks for up to 6 doses for CMT patients~ACE-083: Recombinant fusion protein"
11352565|NCT03943290|EG003|Reported Event|Part 2 Cohort 2a|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352566|NCT03943290|EG004|Reported Event|Part 2 Cohort 2b|"ACE-083 Administered into the BB muscle q4w for up to 24 months (24 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352567|NCT03943290|EG005|Reported Event|Part 2 Cohort 2c|"ACE-083 Administered into the TA muscle q4w for up to 24 months (24 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11352568|NCT03943290|EG006|Reported Event|Part 2 Cohort 3a|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352569|NCT03943290|EG007|Reported Event|Part 2 Cohort 3b|"ACE-083 Administered into the BB muscle q8w for up to 24 months (12 doses) for FSHD patients~ACE-083: Recombinant fusion protein"
11352570|NCT03943290|EG008|Reported Event|Part 2 Cohort 3c|"ACE-083 Administered into the TA muscle q8w for up to 24 months (12 doses) for CMT patients~ACE-083: Recombinant fusion protein"
11357259|NCT03762213|BG000|Baseline|Oculus GO VR HMD, Application Happy Place (© Mimerse)|"Oculus GO is a stand-alone, consumer-grade, virtual reality head-mounted display (HMD). The HMD is placed on the head of the user blocking off the surrounding environment. The visuals and audio are relayed through the HMD in a virtual space.Happy Place (© Mimerse) is a publicly available application with an explicit intent to be used for chronic pain patients. It has the critical elements of VR, namely immersion and interactivity.~Immersion: The scene is a serene lakeside campground with guided relaxation and soothing music. The application intends to promote positive effects such as calmness and feeling of wonder.~Interactivity: Happy Place uses an innovative 'gaze-based interaction' with the virtual world. Around 50 'gaze objects' are placed around the scene and gazing at them would trigger an event.~The entire duration of the experience will be kept at 10 minutes.~Oculus GO VR HMD, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages)."
11357260|NCT03762213|BG001|Baseline|iPad, Application Happy Place (© Mimerse)|"An iPad with earphones (Apple Inc. Cupertino CA) will be used for controls. The participants in control group will watch the same content for the same duration on an iPad screen (flat version of Happy Place). This experience will be different from the intervention group in two ways: first, lack of an immersive environment, and second, lack of interactivity with the environment.~iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages)."
11357261|NCT03762213|BG002|Baseline|Total|Total of all reporting groups
11357262|NCT03762213|FG000|Participant Flow|Oculus GO VR HMD, Application Happy Place (© Mimerse)|"Oculus GO is a stand-alone, consumer-grade, virtual reality head-mounted display (HMD). The HMD is placed on the head of the user blocking off the surrounding environment. The visuals and audio are relayed through the HMD in a virtual space.Happy Place (© Mimerse) is a publicly available application with an explicit intent to be used for chronic pain patients. It has the critical elements of VR, namely immersion and interactivity.~Immersion: The scene is a serene lakeside campground with guided relaxation and soothing music. The application intends to promote positive effects such as calmness and feeling of wonder.~Interactivity: Happy Place uses an innovative 'gaze-based interaction' with the virtual world. Around 50 'gaze objects' are placed around the scene and gazing at them would trigger an event.~The entire duration of the experience will be kept at 10 minutes.~Oculus GO VR HMD, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages)."
11357263|NCT03762213|FG001|Participant Flow|iPad, Application Happy Place (© Mimerse)|"An iPad with earphones (Apple Inc. Cupertino CA) will be used for controls. The participants in control group will watch the same content for the same duration on an iPad screen (flat version of Happy Place). This experience will be different from the intervention group in two ways: first, lack of an immersive environment, and second, lack of interactivity with the environment.~iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages)."
11352571|NCT03942042|BG000|Baseline|Ixekizumab - Generalized Pustular Psoriasis (GPP)|"Induction Dosing Period:~Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.~Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352572|NCT03942042|BG001|Baseline|Ixekizumab - Erythrodermic Psoriasis (EP)|"Induction Dosing Period:~Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.~Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352573|NCT03942042|BG002|Baseline|Total|Total of all reporting groups
11352574|NCT03942042|FG000|Participant Flow|Ixekizumab - Generalized Pustular Psoriasis (GPP)|"Induction Dosing Period:~Participants received 160 milligrams (mg) ixekizumab subcutaneously (SC) as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.~Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352575|NCT03942042|FG001|Participant Flow|Ixekizumab - Erythrodermic Psoriasis (EP)|"Induction Dosing Period:~Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.~Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352576|NCT03942042|OG000|Outcome|Ixekizumab - Generalized Pustular Psoriasis (GPP)|"Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352577|NCT03942042|OG001|Outcome|Ixekizumab - Erythrodermic Psoriasis (EP)|"Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352578|NCT03942042|OG000|Outcome|Ixekizumab - Generalized Pustular Psoriasis (GPP)|"Induction Dosing Period:~Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.~Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352579|NCT03942042|OG001|Outcome|Ixekizumab - Erythrodermic Psoriasis (EP)|"Induction Dosing Period:~Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.~Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352580|NCT03942042|EG000|Reported Event|Ixekizumab GPP-Induction Dosing Period|"Induction Dosing Period:~Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10."
11352581|NCT03942042|EG001|Reported Event|Ixekizumab EP-Induction Dosing Period|"Induction Dosing Period:~Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10."
11352582|NCT03942042|EG002|Reported Event|Ixekizumab GPP-Combined Induction and Maintenance Periods|"Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352583|NCT03942042|EG003|Reported Event|Ixekizumab EP-Combined Induction and Maintenance Periods|"Maintenance Dosing Period:~Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.~Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1."
11352584|NCT03938337|BG000|Baseline|Cohort 1 Not Previously Treated|"Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.~Cohort 1 Not Previously Treated: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks"
11352585|NCT03938337|BG001|Baseline|Cohort 2 Treated Previously|"Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.~Cohort 2 Treated Previously: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks"
11352586|NCT03938337|BG002|Baseline|Total|Total of all reporting groups
11352587|NCT03938337|FG000|Participant Flow|Cohort 1 Not Previously Treated|"Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.~Cohort 1 Not Previously Treated: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks"
11352588|NCT03938337|FG001|Participant Flow|Cohort 2 Treated Previously|"Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.~Cohort 2 Treated Previously: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks"
11352589|NCT03938337|OG000|Outcome|Cohort 1 Not Previously Treated|"Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.~Cohort 1 Not Previously Treated: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks"
11352590|NCT03938337|OG001|Outcome|Cohort 2 Treated Previously|"Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.~Cohort 2 Treated Previously: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks"
11352591|NCT03938337|EG000|Reported Event|Cohort 1 Not Previously Treated|"Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.~Cohort 1 Not Previously Treated: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks"
11352592|NCT03938337|EG001|Reported Event|Cohort 2 Treated Previously|"Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.~Cohort 2 Treated Previously: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks"
11352593|NCT03923530|BG000|Baseline|Eplerenone|"All subjects will receive study drug daily.~Eplerenone: 50mg daily~Kansas City Cardiomyopathy Questionnaire: administered at baseline and 8 weeks~Serum potassium: within the last 30 days is required before initiating eplerenone, repeat blood draw within the first week and starting eplerenone and 4 weeks after starting eplerenone"
11352594|NCT03923530|FG000|Participant Flow|Eplerenone|All subjects will receive eplerenone 50 mg daily. The Kansas City Cardiomyopathy Questionnaire-12 will be administered at baseline and 8 weeks. Serum potassium within the last 30 days is required before initiating eplerenone, repeat blood draw within the first week of starting eplerenone and at 4 weeks.
11352595|NCT03923530|OG000|Outcome|Eplerenone|Eplerenone 50 mg daily administered orally to subjects
11352596|NCT03923530|EG000|Reported Event|Eplerenone|Eplerenone 50 mg daily administered orally to subjects
11352597|NCT03914417|BG000|Baseline|Imiquimod 3.75% Cream|Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
11352598|NCT03914417|FG000|Participant Flow|Imiquimod 3.75% Cream|Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
11352599|NCT03914417|OG000|Outcome|Imiquimod 3.75% Cream|Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
11352600|NCT03914417|EG000|Reported Event|Imiquimod 3.75% Cream|Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
11352601|NCT03913377|BG000|Baseline|Observational Arm|Subjects wearing their habitual spectacle wearers during the course of the study. This arm was included in the study to investigate ocular characteristics among habitual spectacle wearers which served as a reference group.
11352602|NCT03913377|BG001|Baseline|Interventional Arms|Participants assigned to the interentional arm to wear the Test lens and their own spectacles in a random order.
11352603|NCT03913377|BG002|Baseline|Total|Total of all reporting groups
11352604|NCT03913377|FG000|Participant Flow|Observational|Participants wearing their habitual spectacle wearers during the course of the study. This arm was included in the study to investigate ocular characteristics among habitual spectacle wearers which served as a reference group.
11352605|NCT03913377|FG001|Participant Flow|Interventional: Test (Senofilcon A)/Control (Spectacle)|Subjects randomized to this sequence received the Test lens (senofilcon A) during the first period and then worn their spectacles (Control) during the second period.
11352606|NCT03913377|FG002|Participant Flow|Interventional: Control (Spectacle)/Test (Senofilcon A)|Subjects randomized to this sequence worn their spectacles (Control) during the first period and then received the Test lens (senofilcon A) during the second period.
11352607|NCT03913377|OG000|Outcome|Test (Senofilcon A)|Subjects that wore the Test article in either the first or second period of the study.
11352608|NCT03913377|OG001|Outcome|Control (Spectacle)|Subjects that wore their spectacles in either the first or second period of the study.
11352609|NCT03913377|EG000|Reported Event|Observational|Participants wearing their habitual spectacle wearers during the course of the study. This arm was included in the study to investigate ocular characteristics among habitual spectacle wearers which served as a reference group.
11352610|NCT03913377|EG001|Reported Event|Test (Senofilcon A)|Subjects that wore the Test article in either the first or second period of the study.
11352611|NCT03913377|EG002|Reported Event|Control (Spectacle)|Subjects that wore their spectacles in either the first or second period of the study.
11352612|NCT03937791|BG000|Baseline|Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells|"1x10^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0.~E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10^11 cells) will be administered intravenously over 20 to 30 minutes."
11352613|NCT03937791|FG000|Participant Flow|Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells|"1x10^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0.~E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10^11 cells) will be administered intravenously over 20 to 30 minutes."
11352614|NCT03937791|OG000|Outcome|Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells|"1x10^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0.~E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10^11 cells) will be administered intravenously over 20 to 30 minutes."
11352615|NCT03937791|EG000|Reported Event|Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells|"1x10^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0.~E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10^11 cells) will be administered intravenously over 20 to 30 minutes."
11352616|NCT03937778|BG000|Baseline|Tourniquet Block to Left Upper Arm|Participants underwent ~10 minutes of baseline testing followed by a tourniquet placement to left upper arm and inflated to 80-100 mmHG above systolic blood pressure. Participants repeatedly rated a variety of sensory stimuli after tourniquet was placed. Participants rated intensity and pleasantness of slow brushing and deep pressure on both hands/forearms at baseline and after loss of A-beta sensation.
11352617|NCT03937778|FG000|Participant Flow|Tourniquet Block to Left Upper Arm|Participants underwent ~10 minutes of baseline testing followed by a tourniquet placement to left upper arm and inflated to 80-100 mmHG above systolic blood pressure. Participants repeatedly rated a variety of sensory stimuli after tourniquet was placed. Participants rated intensity and pleasantness of slow brushing and deep pressure on both hands/forearms at baseline and after loss of A-beta sensation.
11352618|NCT03937778|OG000|Outcome|Tourniquet Block to Left Upper Arm|Participants underwent ~10 minutes of baseline testing followed by a tourniquet placement to left upper arm and inflated to 80-100 mmHG above systolic blood pressure. Participants repeatedly rated a variety of sensory stimuli after tourniquet was placed. Participants rated intensity and pleasantness of slow brushing and deep pressure on both hands/forearms at baseline and after loss of A-beta sensation.
11352619|NCT03937778|EG000|Reported Event|Tourniquet Block to Left Upper Arm|Participants underwent ~10 minutes of baseline testing followed by a tourniquet placement to left upper arm and inflated to 80-100 mmHG above systolic blood pressure. Participants repeatedly rated a variety of sensory stimuli after tourniquet was placed. Participants rated intensity and pleasantness of slow brushing and deep pressure on both hands/forearms at baseline and after loss of A-beta sensation.
11352620|NCT03937479|BG000|Baseline|RPL554 0.375 mg|Patients were administered 0.375 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352621|NCT03937479|BG001|Baseline|RPL554 0.75 mg|Patients were administered 0.75 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352622|NCT03937479|BG002|Baseline|RPL554 1.5 mg|Patients were administered 1.5 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352623|NCT03937479|BG003|Baseline|RPL554 3.0 mg|Patients were administered 3.0 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352624|NCT03937479|BG004|Baseline|Placebo|Patients were administered placebo (matching with RPL554) by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352625|NCT03937479|BG005|Baseline|Total|Total of all reporting groups
11352626|NCT03937479|FG000|Participant Flow|RPL554 0.375 mg|Patients were administered 0.375 milligram (mg) RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352627|NCT03937479|FG001|Participant Flow|RPL554 0.75 mg|Patients were administered 0.75 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352628|NCT03937479|FG002|Participant Flow|RPL554 1.5 mg|Patients were administered 1.5 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352629|NCT03937479|FG003|Participant Flow|RPL554 3.0 mg|Patients were administered 3.0 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352630|NCT03937479|FG004|Participant Flow|Placebo|Patients were administered placebo (matching with RPL554) by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352631|NCT03937479|OG000|Outcome|RPL554 0.375 mg|Patients were administered 0.375 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352632|NCT03937479|OG001|Outcome|RPL554 0.75 mg|Patients were administered 0.75 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352633|NCT03937479|OG002|Outcome|RPL554 1.5 mg|Patients were administered 1.5 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352634|NCT03937479|OG003|Outcome|RPL554 3.0 mg|Patients were administered 3.0 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352635|NCT03937479|OG004|Outcome|Placebo|Patients were administered placebo (matching with RPL554) by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning.
11352636|NCT03937479|EG000|Reported Event|RPL554 0.375 mg|Patients were administered 0.375 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning. Patients were classified according to actual treatment received for safety analysis set.
11352637|NCT03937479|EG001|Reported Event|RPL554 0.75 mg|Patients were administered 0.75 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning. Patients were classified according to actual treatment received for safety analysis set.
11352638|NCT03937479|EG002|Reported Event|RPL554 1.5 mg|Patients were administered 1.5 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning. Patients were classified according to actual treatment received for safety analysis set.
11352639|NCT03937479|EG003|Reported Event|RPL554 3.0 mg|Patients were administered 3.0 mg RPL554 by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning. Patients were classified according to actual treatment received for safety analysis set.
11352640|NCT03937479|EG004|Reported Event|Placebo|Patients were administered placebo (matching with RPL554) by jet nebulizer twice daily (morning and evening) for 4 weeks. Open-label tiotropium was administered once daily in the morning. Patients were classified according to actual treatment received for safety analysis set.
11352641|NCT03936387|BG000|Baseline|Bilateral Erector Spinae Blocks|"Bilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH.~Ropivacaine: Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side."
11352642|NCT03936387|FG000|Participant Flow|Bilateral Erector Spinae Blocks|"Bilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH.~Ropivacaine: Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side."
11352643|NCT03936387|OG000|Outcome|Bilateral Erector Spinae Blocks|"Bilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH.~Ropivacaine: Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side."
11352644|NCT03936387|EG000|Reported Event|Bilateral Erector Spinae Blocks|"Bilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH.~Ropivacaine: Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side."
11352645|NCT03935399|BG000|Baseline|Oxytocin First, Then Saline Placebo|"Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day~Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection~Saline: 1.5 ml preservative free saline for intramuscular injection"
11352646|NCT03935399|BG001|Baseline|Saline Placebo First, Then Oxytocin|"Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day~Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection~Saline: 1.5 ml preservative free saline for intramuscular injection"
11352647|NCT03935399|BG002|Baseline|Total|Total of all reporting groups
11352648|NCT03935399|FG000|Participant Flow|Oxytocin First, Then Saline Placebo|"Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day~Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection~Saline: 1.5 ml preservative free saline for intramuscular injection"
11352649|NCT03935399|FG001|Participant Flow|Saline Placebo First, Then Oxytocin|"Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day~Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection~Saline: 1.5 ml preservative free saline for intramuscular injection"
11352650|NCT03935399|OG000|Outcome|Oxytocin|Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
11352651|NCT03935399|OG001|Outcome|Placebo|Saline: 1.5 ml preservative free saline for intramuscular injection
11352652|NCT03935399|EG000|Reported Event|Oxytocin|Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection
11352653|NCT03935399|EG001|Reported Event|Placebo|Saline: 1.5 ml preservative free saline for intramuscular injection
11352654|NCT03936608|BG000|Baseline|Individualized RV-LV Pacing Offset|Programming individualized RV-LV pacing offset to optimize ECG: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.
11352655|NCT03936608|BG001|Baseline|No RV-LV Pacing Offset|Nominally programming CRT device without RV-LV offset: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.
11352656|NCT03936608|BG002|Baseline|Total|Total of all reporting groups
11352657|NCT03936608|FG000|Participant Flow|Individualized RV-LV Pacing Offset|Programming individualized RV-LV pacing offset to optimize ECG: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.
11352658|NCT03936608|FG001|Participant Flow|No RV-LV Pacing Offset|Nominally programming CRT device without RV-LV offset: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.
11352659|NCT03936608|OG000|Outcome|Individualized RV-LV Pacing Offset|Programming individualized RV-LV pacing offset to optimize ECG: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.
11352660|NCT03936608|OG001|Outcome|No RV-LV Pacing Offset|Nominally programming CRT device without RV-LV offset: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.
11352661|NCT03936608|EG000|Reported Event|Individualized RV-LV Pacing Offset|Programming individualized RV-LV pacing offset to optimize ECG: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.
11352662|NCT03936608|EG001|Reported Event|No RV-LV Pacing Offset|Nominally programming CRT device without RV-LV offset: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.
11352663|NCT03936244|BG000|Baseline|M-TURP|"The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352664|NCT03936244|BG001|Baseline|PK-TURP|"The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352665|NCT03936244|BG002|Baseline|Total|Total of all reporting groups
11352666|NCT03936244|FG000|Participant Flow|M-TURP|"The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352667|NCT03936244|FG001|Participant Flow|PK-TURP|"The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352668|NCT03936244|OG000|Outcome|M-TURP|"The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352669|NCT03936244|OG001|Outcome|PK-TURP|"The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352670|NCT03936244|OG000|Outcome|M-TURP|"The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352671|NCT03936244|EG000|Reported Event|M-TURP|"The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352672|NCT03936244|EG001|Reported Event|PK-TURP|"The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator~Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP"
11352673|NCT03935126|BG000|Baseline|All Enrolled|All enrolled participants who had geographic atrophy secondary to age-related macular degeneration, signed informed consent for this trial, and met all inclusion criteria and none of the exclusion criteria, for evaluating the usage of microperimetry and Swept Source - Optical Coherence Tomography (SS-OCT) in assessing the natural changes of retinal sensitivity and anatomy in the retina. Each participant was planned to be observed for an observation period of 48 weeks after screening visit. During the observation period, 4 visits were planned to be taken at Week 0, 12, 24, and 48 of the observation period.
11352674|NCT03935126|FG000|Participant Flow|All Enrolled|All enrolled participants who had geographic atrophy secondary to age-related macular degeneration, signed informed consent for this trial, and met all inclusion criteria and none of the exclusion criteria, for evaluating the usage of microperimetry and Swept Source - Optical Coherence Tomography (SS-OCT) in assessing the natural changes of retinal sensitivity and anatomy in the retina. Each participant was planned to be observed for an observation period of 48 weeks after screening visit. During the observation period, 4 visits were planned to be taken at Week 0, 12, 24, and 48 of the observation period.
11352675|NCT03935126|OG000|Outcome|All Enrolled|All enrolled participants who had geographic atrophy secondary to age-related macular degeneration, signed informed consent for this trial, and met all inclusion criteria and none of the exclusion criteria, for evaluating the usage of microperimetry and Swept Source - Optical Coherence Tomography (SS-OCT) in assessing the natural changes of retinal sensitivity and anatomy in the retina. Each participant was planned to be observed for an observation period of 48 weeks after screening visit. During the observation period, 4 visits were planned to be taken at Week 0, 12, 24, and 48 of the observation period.
11352676|NCT03935126|EG000|Reported Event|All Enrolled|All enrolled participants who had geographic atrophy secondary to age-related macular degeneration, signed informed consent for this trial, and met all inclusion criteria and none of the exclusion criteria, for evaluating the usage of microperimetry and Swept Source - Optical Coherence Tomography (SS-OCT) in assessing the natural changes of retinal sensitivity and anatomy in the retina. Each participant was planned to be observed for an observation period of 48 weeks after screening visit. During the observation period, 4 visits were planned to be taken at Week 0, 12, 24, and 48 of the observation period.
11352677|NCT03928327|BG000|Baseline|Part 1, Treatment Sequence AB|TAK-788 20 mg, capsule, at Hour 0 on Day 1 followed by an overnight fast (Treatment A). Following Treatment A, participants received itraconazole 200 mg solution, orally, once daily (QD) on Days 1 to Day 14 and a single oral dose of TAK-788 20 mg capsule was coadministered on Day 5 (Treatment B). There was a washout period of 7 days between the two treatments.
11352678|NCT03928327|BG001|Baseline|Part 2, Treatment Sequence CD|TAK-788 160 mg, orally, at Hour 0 on Day 1 following an overnight fast (Treatment C). Following Treatment C, participants received rifampin 600 mg as capsules, orally, once daily (QD) on Days 1 to 13 and TAK-788 160 mg as capsules, orally was coadministered on Day 7 (Treatment D). There was a washout period of 7 days between the two treatments.
11352679|NCT03928327|BG002|Baseline|Total|Total of all reporting groups
11352680|NCT03928327|FG000|Participant Flow|Part 1, Treatment Sequence AB|TAK-788 20 mg, capsule, at Hour 0 on Day 1 followed by an overnight fast (Treatment A). Following Treatment A, participants received itraconazole 200 mg solution, orally, once daily (QD) on Days 1 to Day 14 and a single oral dose of TAK-788 20 mg capsule was coadministered on Day 5 (Treatment B). There was a washout period of 7 days between the two treatments.
11352681|NCT03928327|FG001|Participant Flow|Part 2, Treatment Sequence CD|TAK-788 160 mg, orally, at Hour 0 on Day 1 following an overnight fast (Treatment C). Following Treatment C, participants received rifampin 600 mg as capsules, orally, once daily (QD) on Days 1 to 13 and TAK-788 160 mg as capsules, orally was coadministered on Day 7 (Treatment D). There was a washout period of 7 days between the two treatments.
11352682|NCT03928327|OG000|Outcome|Part 1, Treatment A|TAK-788 20 mg, capsule, at Hour 0 on Day 1 followed by an overnight fast in Period 1.
11352683|NCT03928327|OG001|Outcome|Part 1, Treatment B|Following Treatment A, participants received itraconazole 200 mg solution, orally, once daily (QD) on Days 1 to Day 14 and a single oral dose of TAK-788 20 mg capsule was coadministered on Day 5 in Period 2.
11352684|NCT03928327|OG000|Outcome|Part 2, Treatment C|TAK-788 160 mg, orally, at Hour 0 on Day 1 following an overnight fast in Period 1.
11352685|NCT03928327|OG001|Outcome|Part 2, Treatment D|Following Treatment C, participants received rifampin 600 mg as capsules, orally, once daily (QD) on Days 1 to 13 and TAK-788 160 mg as capsules, orally was coadministered on Day 7 in Period 2.
11352686|NCT03928327|OG002|Outcome|Part 2, Treatment C|TAK-788 160 mg, orally, at Hour 0 on Day 1 following an overnight fast in Period 1.
11352687|NCT03928327|OG003|Outcome|Part 2, Treatment D|Following Treatment C, participants received rifampin 600 mg as capsules, orally, once daily (QD) on Days 1 to 13 and TAK-788 160 mg as capsules, orally was coadministered on Day 7 in Period 2.
11352688|NCT03928327|EG000|Reported Event|Part 1, Treatment A|TAK-788 20 mg, capsule, at Hour 0 on Day 1 followed by an overnight fast in Period 1.
11352689|NCT03928327|EG001|Reported Event|Part 1, Treatment B|Following Treatment A, participants received itraconazole 200 mg solution, orally, once daily (QD) on Days 1 to Day 14 and a single oral dose of TAK-788 20 mg capsule was coadministered on Day 5 in Period 2.
11352690|NCT03928327|EG002|Reported Event|Part 2, Treatment C|TAK-788 160 mg, orally, at Hour 0 on Day 1 following an overnight fast in Period 1.
11352691|NCT03928327|EG003|Reported Event|Part 2, Treatment D|Following Treatment C, participants received rifampin 600 mg as capsules, orally, once daily (QD) on Days 1 to 13 and TAK-788 160 mg as capsules, orally was coadministered on Day 7 in Period 2.
11352692|NCT03933462|BG000|Baseline|All Participants|All participants that signed a consent form.
11352693|NCT03933462|FG000|Participant Flow|InnoSpire Go, Then Current Jet Nebulizer|Participants first assigned to use the InnoSpire Go for nebulizer treatments for 30 days. Then they then were assigned to use their current jet nebulizer for nebulizer treatments for 30 days
11352694|NCT03933462|FG001|Participant Flow|Current Jet Nebulizer, Then Innospire Go|Participants first assigned to use their current jet nebulizer for nebulizer treatments for 30 days. Then they then were assigned to use Innospire Go for nebulizer treatments for 30 days.
11352695|NCT03933462|OG000|Outcome|InnoSpire Go|"The InnoSpire Go is a handheld, single patient use, vibrating mesh nebulizer system designed to aerosolize liquid medications for respiratory disease. The device operates continuously once initiated and automatically switches off once the medication has been delivered. The device may be used in pediatric and adult populations, as permitted by the prescribed medication, and is suitable for use in home environments or hospital/clinic settings.~InnoSpire Go: Participants will use for 30 days."
11352696|NCT03933462|OG001|Outcome|Jet Nebulizer|"Jet Nebulizers are the standard delivery system for aerosolized medications. A nebulizer breaks up medical solutions into small droplets suspended in air (aerosol) so that they may be delivered to the patient's airways for respiratory therapy.~Jet Nebulizer: Participants will use for 30 days."
11352697|NCT03933462|EG000|Reported Event|InnoSpire Go|Participants first assigned to use the InnoSpire Go for nebulizer treatments for 30 days.
11352698|NCT03933462|EG001|Reported Event|Jet Nebulizer|Participants first assigned to use their current jet nebulizer for nebulizer treatments for 30 days.
11352699|NCT03933774|BG000|Baseline|Left Tretinoin 0.05% Cream, Right Placebo|The left/right sides of the face were randomly allocated to receive either topical tretinoin 0.05% (w/v) cream or moisturizer twice daily. Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) was applied on the half side of the face of the patients for 1 month, once a day every night.
11352700|NCT03933774|BG001|Baseline|Left Placebo, Right Tretinoin 0.05% Cream|The left/right sides of the face were randomly allocated to receive either topical tretinoin 0.05% (w/v) cream or moisturizer twice daily. Placebo cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) was applied on the other half side of the face of the patients for 1 month, once a day every night.
11352701|NCT03933774|BG002|Baseline|Total|Total of all reporting groups
11352702|NCT03933774|FG000|Participant Flow|Left Tretinoin 0.05% Cream, Right Placebo|Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) on the left side of the face, moisturizer cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) on the right side of the face for 1 month, applied once a day every night
11352703|NCT03933774|FG001|Participant Flow|Left Placebo, Right Tretinoin 0.05% Cream|Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) on the right side of the face, moisturizer cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) on the left side of the face for 1 month, applied once a day every night
11352704|NCT03933774|OG000|Outcome|Left Tretinoin 0.05% Cream, Right Placebo|Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the left side, placebo cream on the right side of the face applied once a day every night
11352705|NCT03933774|OG001|Outcome|Left Placebo, Right Tretinoin 0.05% Cream|Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the right side, placebo cream on the left side of the face applied once a day every night
11352706|NCT03933774|EG000|Reported Event|Tretinoin 0.05% Cream Group|"Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face once a day every night~Tretinoin 0.05% cream: Stieva-A Cream 0.05%, 25g, GSK"
11352707|NCT03933774|EG001|Reported Event|Placebo Cream Group|"PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half of the face once a day every night~Placebo cream: Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel"
11352708|NCT03931330|BG000|Baseline|Percutaneous Neurostimulation|"Subjects will have 4 weeks of active therapy.~Percutaneous neurostimulation: Percutaneous neurostimulation using NSS-2 Bridge device"
11352709|NCT03931330|FG000|Participant Flow|Only Active Devise, Open Label|active devise, 4 weeks
11352710|NCT03931330|OG000|Outcome|Only Active Devise, Open Label|Mitochondrial bioenergetics is decreased in adolescents with FGID, we postulate that a 4 week neuro-stimulation with an EAD that has already shown to increase vagal tone will produce an increase in mitochondrial bioenergetics in this patient group.
11352711|NCT03931330|OG000|Outcome|Only Active Devise, Open Label|active devise, 4 weeks
11352712|NCT03931330|EG000|Reported Event|Only Active Device, Open Label|active device, 4 weeks
11352713|NCT03918811|BG000|Baseline|Positive Pressure Extubation Technique|"ETT is removed in PSV 15/10 mode and without endotracheal suction.~Positive Pressure Extubation Technique: Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx."
11352714|NCT03918811|BG001|Baseline|Traditional Extubation Technique|"ETT is removed with continuous endotracheal suction~Traditional Extubation Technique: Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator."
11352715|NCT03918811|BG002|Baseline|Total|Total of all reporting groups
11352716|NCT03918811|FG000|Participant Flow|Positive Pressure Extubation Technique|"ETT is removed in PSV 15/10 mode and without endotracheal suction.~Positive Pressure Extubation Technique: Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx."
11167453|NCT01979185|FG001|Participant Flow|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
11167454|NCT01979185|OG000|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
11167455|NCT01979185|OG001|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
11167456|NCT01979185|EG000|Reported Event|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
11167457|NCT01979185|EG001|Reported Event|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
11167458|NCT01979276|BG000|Baseline|ALL Patients|Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
11167459|NCT01979276|FG000|Participant Flow|ALL Patients|Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined (9mg/m2, 12 mg/m2, 15 mg/m2 or 18 mg/m2)
11167460|NCT01979276|OG000|Outcome|ALL Patients|Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
11167461|NCT01979276|EG000|Reported Event|Pomalidomide, Romidepsin, Dexamethasone|"Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined Dexamethasone~Romidepsin: Romidepsin intravenously on days 1 and 15 of a 28-day cycle~pomalidomide: Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle~Dexamethasone: Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle"
11167462|NCT01979445|BG000|Baseline|Prasugrel|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min on Day 1 after the discontinuation of cangrelor infusion."
11167463|NCT01979445|BG001|Baseline|Clopidogrel|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on Day 1.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 and 1.5 hrs after the initiation of cangrelor infusion and within 5 min after the discontinuation of the cangrelor infusion."
11167464|NCT01979445|BG002|Baseline|Total|Total of all reporting groups
11167465|NCT01979445|FG000|Participant Flow|Prasugrel 30 Min After Cangrelor|"Cangrelor intravenously (IV) was administered on Day 1 as a 30 microgram (μg)/kilogram (kg) bolus, followed by 4 μg/kg/minute (min) infusion for 2 hours (hrs).~Prasugrel 60 milligram (mg) was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion)."
11167466|NCT01979445|FG001|Participant Flow|Clopidogrel Within 5 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
11167467|NCT01979445|FG002|Participant Flow|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
11167468|NCT01979445|FG003|Participant Flow|Clopidogrel 1 Hr During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion."
11167469|NCT01979445|OG000|Outcome|Prasugrel 30 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion)."
11167470|NCT01979445|OG001|Outcome|Clopidogrel Within 5 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
11167471|NCT01979445|OG002|Outcome|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
11167472|NCT01979445|OG003|Outcome|Clopidogrel 1 Hr During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion."
11167473|NCT01979445|OG003|Outcome|Clopidogrel 1 Hr During Cangrelor|"Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.~Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs."
11167474|NCT01979445|OG001|Outcome|Clopidogrel Within 5 Min Post Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
11167475|NCT01979445|OG002|Outcome|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
11167476|NCT01979445|OG000|Outcome|Prasugrel 30 Min After Cangrelor|"Prasugrel 60 mg was administered orally 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).~Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1."
11230808|NCT02408523|EG000|Reported Event|Placebo (SS) Treatment Period|"Participants received the following treatment during the Treatment Period (Week 0 to Week 24):~Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg.~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg).~Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).~Participants formed the Safety Set (SS)."
11230809|NCT02408523|EG001|Reported Event|Lacosamide (SS) Treatment Period|"Participants received the following treatment during the Treatment Period (Week 0 to Week 24):~Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg).~Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg).~Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).~Participants formed the SS."
11230810|NCT02408523|EG002|Reported Event|Placebo (SS) Transition Period|"At the end of Visit 10 (Week 24)/ Early Termination (ET), study participants who completed the study may have been eligible to participate in an open-label extension study (EP0012). Study participants who chose to enroll in the open-label extension study proceeded to a blinded 4-week Transition Period.~Participants randomized to Placebo in the Treatment Period transitioned to double-blind Lacosamide:~Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 100 mg/day until final dose of 400 mg/day at Week 4 for adult and pediatric participants >= 50 kg.~Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day at Week 1. Weekly increase in steps of 2 mg/kg/day until final dose of 8 mg/kg/day at Week 4 for pediatric participants < 30 kg and 0 kg to < 50 kg.~Participants formed the SS."
11230811|NCT02408523|EG003|Reported Event|Lacosamide (SS) Transition Period|"At the end of Visit 10 (Week 24)/ Early Termination (ET), study participants who completed the study may have been eligible to participate in an open-label extension study (EP0012). Study participants who chose to enroll in the open-label extension study proceeded to a blinded 4-week Transition Period.~Participants randomized to Lacosaminde in the Treatment Period continued to receive double-blind Lacosamide:~Lacosamide 50 mg tablets: minim (min) 300 mg/day to maximum (max) 400 mg/day from Week 1 to Week 3 and final dose of 400 mg/day at Week 4 for adult and pediatric participants >= 50 kg.~Lacosamide oral solution 10 mg/ml: min 8 mg/kg/day to max 12 mg/kg/day from Week 1 to Week 4 for pediatric participants < 30 kg.~Lacosamide oral solution 10 mg/ml: min 6 mg/kg/day to max 8 mg/kg/day from Week 1 to Week 3 and final dose of 8 mg/kg/day at Week 4 for pediatric participants 30 kg to < 50 kg.~Participants formed the SS."
11230812|NCT02408523|EG004|Reported Event|Placebo (SS) Taper Period|"Study participants completing Visit 10 (Week 24) or the ET Visit who chose not to continue in EP0012 must have completed an up to 4 weeks blinded taper followed by the End of Taper Visit.~Participants randomized to Placebo in the Treatment Period continued to receive Placebo:~Placebo 50 mg tablets: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 100 mg/day until no treatment received for adult and pediatric participants >= 50 kg.~Placebo oral solution 10 mg/ml: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 2 mg/kg/day or 3 mg/kg/day until no treatment received for pediatric participants < 30 kg and 0 kg to < 50 kg.~Participants formed the SS."
11230813|NCT02408523|EG005|Reported Event|Lacosamide (SS) Taper Period|"Study participants completing Visit 10 (Week 24) or the ET Visit who chose not to continue in EP0012 must have completed an up to 4 weeks blinded taper followed by the End of Taper Visit.~Participants randomized to Lacosamide in the Treatment Period continued to receive Lacosamide:~Lacosamide 50 mg tablets: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 100 mg/day until no treatment received for adult and pediatric participants >= 50 kg.~Lacosamide oral solution 10 mg/ml: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 2 mg/kg/day or 3 mg/kg/day until no treatment received for pediatric participants < 30 kg and 0 kg to < 50 kg.~Participants formed the SS."
11230814|NCT02408523|EG006|Reported Event|Placebo (SS) Safety Follow-up Period|"There was a 30-day (-1/+3 days) Safety Follow-up Period for study participants who completed the End of Taper Visit. The Safety Follow-up Period consisted of a clinic visit 2 weeks after the End of Taper Visit followed 2 weeks later by a telephone contact (TC).~Participants did not receive any treatment during this period. Participants formed the SS."
11230815|NCT02408523|EG007|Reported Event|Lacosamide (SS) Safety Follow-up Period|"There was a 30-day (-1/+3 days) Safety Follow-up Period for study participants who completed the End of Taper Visit. The Safety Follow-up Period consisted of a clinic visit 2 weeks after the End of Taper Visit followed 2 weeks later by a telephone contact (TC).~Participants did not receive any treatment during this period. Participants formed the SS."
11230816|NCT02408692|BG000|Baseline|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
11230817|NCT02408692|BG001|Baseline|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
11230818|NCT02408692|BG002|Baseline|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
11230819|NCT02408692|BG003|Baseline|Total|Total of all reporting groups
11230820|NCT02408692|FG000|Participant Flow|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
11230821|NCT02408692|FG001|Participant Flow|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
11230822|NCT02408692|FG002|Participant Flow|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
11230823|NCT02408692|OG000|Outcome|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
11230824|NCT02408692|OG001|Outcome|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
11230825|NCT02408692|OG002|Outcome|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
11230826|NCT02408692|EG000|Reported Event|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
11230827|NCT02408692|EG001|Reported Event|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
11230828|NCT02408692|EG002|Reported Event|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
11230829|NCT02408796|BG000|Baseline|OTO-201|"6 mg OTO-201~OTO-201"
11230830|NCT02408796|FG000|Participant Flow|OTO-201|"6 mg OTO-201~OTO-201"
11230831|NCT02408796|OG000|Outcome|OTO-201|"6 mg OTO-201~OTO-201"
11230832|NCT02408796|EG000|Reported Event|OTO-201|"6 mg OTO-201~OTO-201"
11230833|NCT02408965|BG000|Baseline|Methergine|Methergine group
11230834|NCT02408965|BG001|Baseline|Placebo|Placebo group
11230835|NCT02408965|BG002|Baseline|Total|Total of all reporting groups
11230836|NCT02408965|FG000|Participant Flow|Methergine|Methergine group
11230837|NCT02408965|FG001|Participant Flow|Placebo|Placebo group
11230838|NCT02408965|OG000|Outcome|Methergine|Methergine group
11230839|NCT02408965|OG001|Outcome|Placebo|Placebo group
11230840|NCT02408965|EG000|Reported Event|Methergine|Methergine group
11230841|NCT02408965|EG001|Reported Event|Placebo|Placebo group
11230842|NCT02409277|BG000|Baseline|Standard e-AT Intervention|Patients in Standard e-AT intervention group will be using the standard version of e-AT.
11335559|NCT03552549|BG000|Baseline|PEG-Intron|Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery
11230843|NCT02409277|BG001|Baseline|Intensive e-AT Intervention|Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
11230844|NCT02409277|BG002|Baseline|Usual Care (Non-Randomized Cohort)|Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals.
11230845|NCT02409277|BG003|Baseline|Total|Total of all reporting groups
11230846|NCT02409277|FG000|Participant Flow|Standard e-Asthma Tracker (e-AT) Intervention|Patients in Standard e-AT intervention group will be using the standard version of e-AT
11230847|NCT02409277|FG001|Participant Flow|Intensive e-Asthma Tracker (e-AT) Intervention|Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
11230848|NCT02409277|FG002|Participant Flow|Usual Care (Non-Randomized Cohort)|Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals.
11230849|NCT02409277|OG000|Outcome|Standard e-AT Intervention|Patients in Standard e-AT intervention group using the standard version of e-AT.
11230850|NCT02409277|OG001|Outcome|Intensive e-AT Intervention|Participants in the intensive e-AT intervention group using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
11230851|NCT02409277|OG000|Outcome|All e-AT Users|This group consists of all e-AT users, both standard and intensive interventions.
11230852|NCT02409277|OG000|Outcome|Standard e-AT Intervention|Patients in Standard e-AT intervention group will be using the standard version of e-AT.
11230853|NCT02409277|OG001|Outcome|Intensive e-AT Intervention|Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
11230854|NCT02409277|OG000|Outcome|All e-AT Users|This group consists of all e-AT users, both standard and intensive interventions. We will be looking at ACT scores submitted by the e-AT users to report asthma control over 12 months.
11230855|NCT02409277|OG000|Outcome|All e-AT Users|This group consists of all e-AT users, both standard and intensive interventions
11230856|NCT02409277|OG000|Outcome|Prior e-AT Use|The participants enrolled in both standard and intensive e-AT groups served as their own control. This arm includes ED/Hospital use among the participants 1 year before using the e-AT.
11230857|NCT02409277|OG001|Outcome|Post e-AT Use|The participants enrolled in both standard and intensive e-AT groups served as their own control. This arm includes ED/Hospital use among the participants 1 year after starting using the e-AT.
11230858|NCT02409277|OG000|Outcome|Prior e-AT Use|The participants enrolled in both standard and intensive e-AT groups served as their own control. This arm includes oral steriod use among the participants 1 year before using the e-AT.
11230859|NCT02409277|OG001|Outcome|Post e-AT Use|The participants enrolled in both standard and intensive e-AT groups served as their own control. This arm includes the oral steriod use among the participants 1 year after starting using the e-AT.
11230860|NCT02409277|OG000|Outcome|Early Starting Patients|Patients starting with e-AT intervention early (in 2014)
11230861|NCT02409277|OG001|Outcome|Late Starting Patients|Patients starting with e-AT intervention later (in 2015)
11230862|NCT02409277|OG000|Outcome|Early Starting Clinics|ED/Hospital admission for patients in clinics that started with the e-AT intervention from Jan 3, 2014 to Mar 24, 2014.
11230863|NCT02409277|OG001|Outcome|Late Starting Clinics|ED/Hospital admission for patients in clinics that started with the e-AT intervention after March 24, 2014.
11230864|NCT02409277|OG000|Outcome|Early Patients|Oral steroid use between Jan 3, 2014-March 24, 2014 for patients who were enrolled in e-AT intervention from Jan 3, 2014 to Mar 24, 2014.
11230865|NCT02409277|OG001|Outcome|Late Patients|Oral steroid use between Jan 3, 2014-March 24, 2014 for patients who were enrolled into e-AT after March 24, 2014.
11230866|NCT02409277|OG000|Outcome|e-AT Intervention|All e-AT users who have received the e-AT intervention for 12 months, randomized to either standard or intensive group.
11230867|NCT02409277|OG001|Outcome|Usual Care (Non-randomized Cohort)|Those who have not received any e-AT intervention and received usual care.
11230868|NCT02409277|OG001|Outcome|Usual Care (Non-randomized Cohort)|Matched control participants from non-participating clinics that have not received any e-AT intervention and received usual care.
11230869|NCT02409277|EG000|Reported Event|Standard e-AT Intervention|Patients in Standard e-AT intervention group will be using the standard version of e-AT.
11230870|NCT02409277|EG001|Reported Event|Intensive e-AT Intervention|Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
11230871|NCT02409277|EG002|Reported Event|Usual Care (Non-Randomized Cohort)|Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals.
11352717|NCT03918811|FG001|Participant Flow|Traditional Extubation Technique|"ETT is removed with continuous endotracheal suction~Traditional Extubation Technique: Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator."
11352718|NCT03918811|OG000|Outcome|Positive Pressure Extubation Technique|"ETT is removed in PSV 15/10 mode and without endotracheal suction.~Positive Pressure Extubation Technique: Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx."
11352719|NCT03918811|OG001|Outcome|Traditional Extubation Technique|"ETT is removed with continuous endotracheal suction~Traditional Extubation Technique: Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator."
11352720|NCT03918811|EG000|Reported Event|Positive Pressure Extubation Technique|"ETT is removed in PSV 15/10 mode and without endotracheal suction.~Positive Pressure Extubation Technique: Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx."
11167477|NCT01979445|OG001|Outcome|Clopidogrel Within 5 Min After Cangrelor|"Clopidogrel 600 mg was administered orally within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).~Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1."
11167478|NCT01979445|OG002|Outcome|Clopidogrel 1.5 Hrs During Cangrelor|"Clopidogrel 600 mg administered orally 1.5 hrs following the initiation of cangrelor infusion.~Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1."
11167479|NCT01979445|OG003|Outcome|Clopidogrel 1 Hr During Cangrelor|"Clopidogrel 600 mg administered orally 1 hr following the initiation of cangrelor infusion.~Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1."
11167480|NCT01979445|OG000|Outcome|Prasugrel 30 Min After Cangrelor|"Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).~Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs."
11167481|NCT01979445|EG000|Reported Event|Prasugrel 30 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion)."
11167482|NCT01979445|EG001|Reported Event|Clopidogrel Within 5 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
11167483|NCT01979445|EG002|Reported Event|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
11167484|NCT01979445|EG003|Reported Event|Clopidogrel 1 Hr During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion."
11167485|NCT01979523|BG000|Baseline|Arm A (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO"
11167486|NCT01979523|BG001|Baseline|Arm B (Trametinib, Akt Inhibitor GSK2141795)|"Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO"
11167487|NCT01979523|BG002|Baseline|Total|Total of all reporting groups
11167488|NCT01979523|FG000|Participant Flow|Arm A (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO"
11167489|NCT01979523|FG001|Participant Flow|Arm B (Trametinib, Akt Inhibitor GSK2141795)|"Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO"
11167490|NCT01979523|OG000|Outcome|Arm A (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO"
11167491|NCT01979523|OG001|Outcome|Arm B (Trametinib, Akt Inhibitor GSK2141795)|"Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO"
11167492|NCT01979523|EG000|Reported Event|Arm A (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO"
11167493|NCT01979523|EG001|Reported Event|Arm B (Trametinib, Akt Inhibitor GSK2141795)|"Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO"
11167494|NCT01979523|EG002|Reported Event|Crossover Arm|Participants had progression of disease on Arm A and were then treated on Arm B.
11167495|NCT01979614|BG000|Baseline|Serelaxin|Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
11167496|NCT01979614|BG001|Baseline|Placebo|Placebo was administered by intravenous infusion for 48 hours
11167497|NCT01979614|BG002|Baseline|Total|Total of all reporting groups
11167498|NCT01979614|FG000|Participant Flow|Serelaxin|Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
11167499|NCT01979614|FG001|Participant Flow|Placebo|Placebo was administered by intravenous infusion for 48 hours
11167500|NCT01979614|OG000|Outcome|Serelaxin|Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
11167501|NCT01979614|OG001|Outcome|Placebo|Placebo was administered by intravenous infusion for 48 hours
11167502|NCT01979614|EG000|Reported Event|Serelaxin|Serelaxin
11167503|NCT01979614|EG001|Reported Event|Placebo|Placebo
11352721|NCT03918811|EG001|Reported Event|Traditional Extubation Technique|"ETT is removed with continuous endotracheal suction~Traditional Extubation Technique: Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator."
11352722|NCT03933618|BG000|Baseline|Anastrazole-clomiphene-placebo|"anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352723|NCT03933618|BG001|Baseline|Anastrazole-placebo-clomiphene|"anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352724|NCT03933618|BG002|Baseline|Clomiphene-anastrazole-placebo|"clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352725|NCT03933618|BG003|Baseline|Clomiphene-placebo-anastrazole|"clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352726|NCT03933618|BG004|Baseline|Placebo-clomiphene-anastrazole|"placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352727|NCT03933618|BG005|Baseline|Placebo-anastrazole-clomiphene|"placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352728|NCT03933618|BG006|Baseline|Total|Total of all reporting groups
11352729|NCT03933618|FG000|Participant Flow|Anastrazole-clomiphene-placebo|"anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352730|NCT03933618|FG001|Participant Flow|Anastrazole-placebo-clomiphene|"anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352731|NCT03933618|FG002|Participant Flow|Clomiphene-anastrazole-placebo|"clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352732|NCT03933618|FG003|Participant Flow|Clomiphene-placebo-anastrazole|"clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352733|NCT03933618|FG004|Participant Flow|Placebo-clomiphene-anastrazole|"placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352734|NCT03933618|FG005|Participant Flow|Placebo-anastrazole-clomiphene|"placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352735|NCT03933618|OG000|Outcome|Anastrazole-clomiphene-placebo|"anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352736|NCT03933618|OG001|Outcome|Anastrazole-placebo-clomiphene|"anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352737|NCT03933618|OG002|Outcome|Clomiphene-anastrazole-placebo|"clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352738|NCT03933618|OG003|Outcome|Clomiphene-placebo-anastrazole|"clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352739|NCT03933618|OG004|Outcome|Placebo-clomiphene-anastrazole|"placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352740|NCT03933618|OG005|Outcome|Placebo-anastrazole-clomiphene|"placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352741|NCT03933618|EG000|Reported Event|Anastrazole-clomiphene-placebo|"anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352742|NCT03933618|EG001|Reported Event|Anastrazole-placebo-clomiphene|"anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352743|NCT03933618|EG002|Reported Event|Clomiphene-anastrazole-placebo|"clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352744|NCT03933618|EG003|Reported Event|Clomiphene-placebo-anastrazole|"clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352745|NCT03933618|EG004|Reported Event|Placebo-clomiphene-anastrazole|"placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352746|NCT03933618|EG005|Reported Event|Placebo-anastrazole-clomiphene|"placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks~Anastrozole 1mg~Clomiphene Citrate 25mg~Placebo - Cap"
11352747|NCT03931785|BG000|Baseline|Placebo|4 matching placebo oral tablets once daily (QD) for 12 weeks
11352748|NCT03931785|BG001|Baseline|MD-7246 300 μg|1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks
11352749|NCT03931785|BG002|Baseline|MD-7246 600 μg|2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks
11352750|NCT03931785|BG003|Baseline|MD-7246 1200 μg|4 MD-7246 300-μg oral tablets QD for 12 weeks
11352751|NCT03931785|BG004|Baseline|Total|Total of all reporting groups
11352752|NCT03931785|FG000|Participant Flow|Placebo|4 matching placebo oral tablets once daily (QD) for 12 weeks
11352753|NCT03931785|FG001|Participant Flow|MD-7246 300 μg|1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks
11230872|NCT02409329|BG000|Baseline|REACH|"Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.~All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11230873|NCT02409329|BG001|Baseline|REACH + FAMS|"In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for 6 months. After six months, participants in this arm will receive REACH text messages only.~All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.~REACH + FAMS: The intervention consists of REACH individually-focused text mes"
11230874|NCT02409329|BG002|Baseline|Helpline and A1c Results|"Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).~All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11230875|NCT02409329|BG003|Baseline|Total|Total of all reporting groups
11230876|NCT02409329|FG000|Participant Flow|REACH|"Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.~All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11230877|NCT02409329|FG001|Participant Flow|REACH + FAMS|"In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After 6 months, participants in this arm will receive REACH text messages only.~All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.~REACH + FAMS: The intervention consists of REACH individually-focused text mes"
11230878|NCT02409329|FG002|Participant Flow|Helpline and A1c Results|"Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).~All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11230879|NCT02409329|OG000|Outcome|REACH|"Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.~All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11230880|NCT02409329|OG001|Outcome|Helpline and A1c Results|"Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).~All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11352754|NCT03931785|FG002|Participant Flow|MD-7246 600 μg|2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks
11352755|NCT03931785|FG003|Participant Flow|MD-7246 1200 μg|4 MD-7246 300-μg oral tablets QD for 12 weeks
11352756|NCT03931785|OG000|Outcome|Placebo|4 matching placebo oral tablets once daily (QD) for 12 weeks
11352757|NCT03931785|OG001|Outcome|MD-7246 300 μg|1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks
11352758|NCT03931785|OG002|Outcome|MD-7246 600 μg|2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks
11352759|NCT03931785|OG003|Outcome|MD-7246 1200 μg|4 MD-7246 300-μg oral tablets QD for 12 weeks
11352760|NCT03931785|EG000|Reported Event|Placebo|4 matching placebo oral tablets once daily (QD) for 12 weeks
11352761|NCT03931785|EG001|Reported Event|MD-7246 300 μg|1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks
11352762|NCT03931785|EG002|Reported Event|MD-7246 600 μg|2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks
11352763|NCT03931785|EG003|Reported Event|MD-7246 1200 μg|4 MD-7246 300-μg oral tablets QD for 12 weeks
11352764|NCT03930641|BG000|Baseline|RTH258|Brolucizumab 6 mg in a prefilled syringe
11352765|NCT03930641|FG000|Participant Flow|RTH258|Brolucizumab 6 mg in a prefilled syringe
11352766|NCT03930641|OG000|Outcome|RTH258|Brolucizumab 6 mg in a prefilled syringe
11352767|NCT03930641|EG000|Reported Event|RTH258|Brolucizumab 6 mg in a prefilled syringe
11352768|NCT03927846|BG000|Baseline|Nurse Support|Participants received phone-based coaching
11352769|NCT03927846|BG001|Baseline|Control|No contact with the research team
11352770|NCT03927846|BG002|Baseline|Total|Total of all reporting groups
11352771|NCT03927846|FG000|Participant Flow|Nurse Support|Participants received phone-based coaching
11352772|NCT03927846|FG001|Participant Flow|Control|No contact with the research team
11352773|NCT03927846|OG000|Outcome|Nurse Support|Participants received phone-based coaching
11352774|NCT03927846|OG001|Outcome|Control|No contact with the research team
11352775|NCT03927846|EG000|Reported Event|Nurse Support|Participants received phone-based coaching
11352776|NCT03927846|EG001|Reported Event|Control|No contact with the research team
11352777|NCT03927105|BG000|Baseline|Nivolumab + Cabiralizumab|"Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle.~Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens.~Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms)."
11167504|NCT01979835|BG000|Baseline|Women Enrolled to Have GF Inserted|All women requesting a GF and eligible for insertion who signed the informed consent document.
11352778|NCT03927105|FG000|Participant Flow|Nivolumab + Cabiralizumab|"Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Nivolumab will be delivered intravenously at a fixed dose of 240 mg on day 1 of 14 day cycles.~Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). Cabiralizumab will be delivered intravenously at a dosage of 4 mg/kg on day 1 of 14 day cycles."
11352779|NCT03927105|OG000|Outcome|Nivolumab + Cabiralizumab|"Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle.~Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens.~Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms)."
11352780|NCT03927105|EG000|Reported Event|Nivolumab + Cabiralizumab|"Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle.~Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens.~Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms)."
11352781|NCT03923933|BG000|Baseline|Placebo|"This group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day.~Bumetanide: Bumetanide"
11352782|NCT03923933|BG001|Baseline|Treatment Grup|"This group will receive 3 milligrams of bumetanide plus 50 milligrams of chlorthalidone per day, for a week. If the dose is well tolerated, it will be increased to 4 milligrams of bumetanide and 100 milligrams of chlorthalidone per day.~Chlorthalidone: Chlorthalidone~Bumetanide: Bumetanide"
11352783|NCT03923933|BG002|Baseline|Total|Total of all reporting groups
11352784|NCT03923933|FG000|Participant Flow|Placebo|"This group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day.~Bumetanide: Bumetanide"
11167505|NCT01979835|FG000|Participant Flow|Women Who Enrolled to Have a GyneFix Viz Inserted|GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance
11167506|NCT01979835|OG000|Outcome|Women Who Have a GyneFix Viz Inserted|GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance
11167507|NCT01979835|EG000|Reported Event|Women Who Have a GyneFix Viz Inserted|GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance
11167508|NCT01979952|BG000|Baseline|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
11167509|NCT01979952|BG001|Baseline|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
11167510|NCT01979952|BG002|Baseline|Total|Total of all reporting groups
11167511|NCT01979952|FG000|Participant Flow|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
11167512|NCT01979952|FG001|Participant Flow|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
11167513|NCT01979952|OG000|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
11167514|NCT01979952|OG001|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
11167515|NCT01979952|EG000|Reported Event|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
11167516|NCT01979952|EG001|Reported Event|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
11167517|NCT01980056|BG000|Baseline|Dose Level 1: Vosaroxin 50 mg/m^2 IV on Days 1 and 4 of 28 Day|"All patients will receive vosaroxin according to the dose cohort in which they are enrolled.~Vosaroxin: Dose level 1: Vosaroxin 50 mg^m2 IV on Days 1 and 4 of 28 day cycle"
11167518|NCT01980056|BG001|Baseline|Dose Level 2: Vosaroxin 72 mg/m^2 IV on Days 1 and 4 of 28 Day|"All patients will receive vosaroxin according to the dose cohort in which they are enrolled.~Dose level 2: Vosaroxin 72 mg^m2 IV on Days 1 and 4 of 28 day cycle"
11167519|NCT01980056|BG002|Baseline|Dose Level 3: Vosaroxin 50mg/m^2 IV on Days 1, 4, 8 and 11 of|"All patients will receive vosaroxin according to the dose cohort in which they are enrolled.~Dose level 3: Vosaroxin 50 mg^m2 IV on Days 1, 4, 8 and 11 of 28 day cycle"
11167520|NCT01980056|BG003|Baseline|Total|Total of all reporting groups
11167521|NCT01980056|FG000|Participant Flow|Vosaroxin: All Patients Receiving Dose Level 1: Vosaroxin 50 m|"All patients will receive vosaroxin according to the dose cohort in which they are enrolled.~Vosaroxin: Dose level 1: Vosaroxin 50 mg/m^2 IV on Days 1 and 4 of 28 day cycle"
11167522|NCT01980056|FG001|Participant Flow|Dose Level 2: Vosaroxin 72 mg/m^2 IV on Days 1 and 4 of 28 Day|All patient receiving Dose level 2: Vosaroxin 72 mg/m^2 IV on Days 1 and 4 of 28 day cycle
11167523|NCT01980056|FG002|Participant Flow|Dose Level 3: Vosaroxin 50 mg/m^2 IV on Days 1, 4, 8 and 11 of|All patient receiving Dose level 3: Vosaroxin 50 mg/m^2 IV on Days 1, 4, 8 and 11 of 28 day cycle
11167524|NCT01980056|OG000|Outcome|All Study Participants|"All patients will receive vosaroxin according to the dose cohort in which they are enrolled.~Dose level 1: Vosaroxin 50 mg/m^2 IV on Days 1 and 4 of 28 day cycle Dose level 2: Vosaroxin 72 mg/m^2 IV on Days 1 and 4 of 28 day cycle Dose level 3: Vosaroxin 50 mg/m^2 IV on Days 1, 4, 8 and 11 of 28 day cycle"
11167525|NCT01980056|OG000|Outcome|Vosaroxin: Dose Level 1: Vosaroxin 50 mg/m^2 IV on Days 1 & 4|"All patients will receive vosaroxin according to the dose cohort in which they are enrolled.~Vosaroxin: Dose level 1: Vosaroxin 50 mg/m^2 IV on Days 1 and 4 of 28 day cycle"
11167526|NCT01980056|OG001|Outcome|Dose Level 2: Vosaroxin 72 mg/m^2 IV on Days 1 and 4 of 28 Day|Dose level 2: Vosaroxin 72 mg/m^2 IV on Days 1 and 4 of 28 day cycle
11167527|NCT01980056|OG002|Outcome|Dose Level 3: Vosaroxin 50 mg/m^2 IV on Days 1, 4, 8 and 11 of|Dose level 3: Vosaroxin 50 mg/m^2 IV on Days 1, 4, 8 and 11 of 28 day cycle
11167528|NCT01980056|OG000|Outcome|Vosaroxin: Dose Level 1: Vosaroxin 50 mg^m2 IV on Days 1 and 4|"All patients will receive vosaroxin according to the dose cohort in which they are enrolled.~Vosaroxin: Dose level 1: Vosaroxin 50 mg^m2 IV on Days 1 and 4 of 28 day cycle"
11167529|NCT01980056|OG001|Outcome|Dose Level 2: Vosaroxin 72 mg^m2 IV on Days 1 and 4 of 28 Day|Dose level 2: Vosaroxin 72 mg^m2 IV on Days 1 and 4 of 28 day cycle
11167530|NCT01980056|OG002|Outcome|Dose Level 3: Vosaroxin 50 mg^m2 IV on Days 1, 4, 8 and 11 of|Dose level 3: Vosaroxin 50 mg^m2 IV on Days 1, 4, 8 and 11 of 28 day cycle
11167531|NCT01980056|EG000|Reported Event|Dose Level 1: Vosaroxin 50 mg/m2 IV on Days 1 and 4 of 28 Day|Vosaroxin: Dose level 1: Vosaroxin 50 mg/m2 IV on Days 1 and 4 of 28 day cycle
11167532|NCT01980056|EG001|Reported Event|Dose Level 2: Vosaroxin 72 mg/m2 IV on Days 1 and 4 of 28 Day|Dose level 2: Vosaroxin 72 mg/m2 IV on Days 1 and 4 of 28 day cycle
11167533|NCT01980056|EG002|Reported Event|Dose Level 3: Vosaroxin 50 mg/m2 IV on Days 1, 4, 8 and 11 of|Dose level 3: Vosaroxin 50 mg/m2 IV on Days 1, 4, 8 and 11 of 28 day cycle
11167534|NCT01980095|BG000|Baseline|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg."
11167535|NCT01980095|BG001|Baseline|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
11167536|NCT01980095|BG002|Baseline|Total|Total of all reporting groups
11352785|NCT03923933|FG001|Participant Flow|Treatment Grup|"This group will receive 3 milligrams of bumetanide plus 50 milligrams of chlorthalidone per day, for a week. If the dose is well tolerated, it will be increased to 4 milligrams of bumetanide and 100 milligrams of chlorthalidone per day.~Chlorthalidone: Chlorthalidone~Bumetanide: Bumetanide"
11352786|NCT03923933|OG000|Outcome|Placebo|"This group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day.~Bumetanide: Bumetanide"
11352787|NCT03923933|OG001|Outcome|Treatment Grup|"This group will receive 3 milligrams of bumetanide plus 50 milligrams of chlorthalidone per day, for a week. If the dose is well tolerated, it will be increased to 4 milligrams of bumetanide and 100 milligrams of chlorthalidone per day.~Chlorthalidone: Chlorthalidone~Bumetanide: Bumetanide"
11352788|NCT03923933|EG000|Reported Event|Placebo|"This group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day.~Bumetanide: Bumetanide"
11352789|NCT03923933|EG001|Reported Event|Treatment Grup|"This group will receive 3 milligrams of bumetanide plus 50 milligrams of chlorthalidone per day, for a week. If the dose is well tolerated, it will be increased to 4 milligrams of bumetanide and 100 milligrams of chlorthalidone per day.~Chlorthalidone: Chlorthalidone~Bumetanide: Bumetanide"
11352790|NCT03909295|BG000|Baseline|LCZ696|Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
11352791|NCT03909295|FG000|Participant Flow|LCZ696|Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
11352792|NCT03909295|OG000|Outcome|LCZ696 50 mg|Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
11352793|NCT03909295|EG000|Reported Event|LCZ696|Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
11352794|NCT03908970|BG000|Baseline|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11352795|NCT03908970|BG001|Baseline|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
11352796|NCT03908970|BG002|Baseline|Total|Total of all reporting groups
11352797|NCT03908970|FG000|Participant Flow|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11352798|NCT03908970|FG001|Participant Flow|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
11352799|NCT03908970|OG000|Outcome|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11352800|NCT03908970|OG001|Outcome|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
11352801|NCT03908970|EG000|Reported Event|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11352802|NCT03908970|EG001|Reported Event|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
11352803|NCT03897179|BG000|Baseline|INVSENSOR00032 and INVSENSOR00033 Test Group|"All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.~INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device"
11352804|NCT03897179|FG000|Participant Flow|INVSENSOR00032 and INVSENSOR00033 Test Group|"All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.~INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device"
11352805|NCT03897179|OG000|Outcome|INVSENSOR00032 and INVSENSOR00033 Test Group|"All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.~INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device"
11352806|NCT03897179|EG000|Reported Event|INVSENSOR00032 and INVSENSOR00033 Test Group|"All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.~INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device"
11352807|NCT03930264|BG000|Baseline|Imurek®, First|"Generic name : Azathioprine Trade name : Imurek® 50mg tablet Dosage form : Tablet containing 50 mg azathioprine Dose : 1 x Imurek 50mg Tablet per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Aspen Pharma Trading Limited, Dublin, Ireland Country of origin : Ireland~Azathioprine: tablet"
11352808|NCT03930264|BG001|Baseline|Jayempi™, First|"Generic name : Azathioprine~Trade name : (Jayempi™) 10 mg/ mL Oral solution Dosage form : Oral suspension containing 10 mg/mL Azathioprine Dose : 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Nova Laboratories Ltd. Country of origin : Leicester, UK~Azathioprine: oral suspension"
11352809|NCT03930264|BG002|Baseline|Total|Total of all reporting groups
11352810|NCT03930264|FG000|Participant Flow|Imurek®, First|"Generic name : Azathioprine Trade name : Imurek® 50mg tablet Dosage form : Tablet containing 50 mg azathioprine Dose : 1 x Imurek 50mg Tablet per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Aspen Pharma Trading Limited, Dublin, Ireland Country of origin : Ireland~Azathioprine: tablet"
11230881|NCT02409329|OG001|Outcome|REACH + FAMS|"In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After 6 months, participants in this arm will receive REACH text messages only.~All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.~REACH + FAMS: The intervention consists of REACH individually-focused text mes"
11230882|NCT02409329|OG002|Outcome|Helpline and A1c Results|"Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).~All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11230883|NCT02409329|EG000|Reported Event|REACH|"Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.~All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11230884|NCT02409329|EG001|Reported Event|REACH + FAMS|"In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for 6 months. After six months, participants in this arm will receive REACH text messages only.~All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.~REACH + FAMS: The intervention consists of REACH individually-focused text mes"
11230885|NCT02409329|EG002|Reported Event|Helpline and A1c Results|"Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).~All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions."
11230886|NCT02409459|BG000|Baseline|Placebo|Group B: Placebo
11230887|NCT02409459|BG001|Baseline|Injectafer|Group A: Injectafer
11230888|NCT02409459|BG002|Baseline|Total|Total of all reporting groups
11230889|NCT02409459|FG000|Participant Flow|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
11230890|NCT02409459|FG001|Participant Flow|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
11230891|NCT02409459|OG000|Outcome|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
11230892|NCT02409459|OG001|Outcome|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
11230893|NCT02409459|EG000|Reported Event|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
11230894|NCT02409459|EG001|Reported Event|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Placebo: Normal saline solution"
11230895|NCT02409667|BG000|Baseline|Treatment Period 1: All Participants|Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
11230896|NCT02409667|FG000|Participant Flow|Treatment Period 1: All Participants|Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
11230897|NCT02409667|FG001|Participant Flow|Treatment Period 2: Group 1|Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
11230898|NCT02409667|FG002|Participant Flow|Treatment Period 2: Group 2|Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
11352811|NCT03930264|FG001|Participant Flow|Jayempi™ First|"Generic name : Azathioprine~Trade name : (Jayempi™) 10 mg/ mL Oral solution Dosage form : Oral suspension containing 10 mg/mL Azathioprine Dose : 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Nova Laboratories Ltd. Country of origin : Leicester, UK~Azathioprine: oral suspension"
11352812|NCT03930264|OG000|Outcome|Imurek|Tablet formulation
11352813|NCT03930264|OG001|Outcome|Jayempi™|Liquid formulation
11352814|NCT03930264|EG000|Reported Event|Imurek®|"Generic name : Azathioprine Trade name : Imurek® 50mg tablet Dosage form : Tablet containing 50 mg azathioprine Dose : 1 x Imurek 50mg Tablet per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Aspen Pharma Trading Limited, Dublin, Ireland Country of origin : Ireland~Azathioprine: tablet"
11352815|NCT03930264|EG001|Reported Event|Jayempi™|"Generic name : Azathioprine~Trade name : (Jayempi™) 10 mg/ mL Oral solution Dosage form : Oral suspension containing 10 mg/mL Azathioprine Dose : 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Nova Laboratories Ltd. Country of origin : Leicester, UK~Azathioprine: oral suspension"
11352816|NCT03929367|BG000|Baseline|Oxytocin (Pitocin®), 10 IU|"Oxytocin 10 IU administered once per intravenous injection~Oxytocin: Single IV administration of oxytocin"
11352817|NCT03929367|FG000|Participant Flow|Oxytocin (Pitocin®), 10 IU|"Oxytocin 10 IU administered once per intravenous injection~Oxytocin: Single IV administration of oxytocin"
11352818|NCT03929367|OG000|Outcome|Oxytocin (Pitocin®), 10 IU|"Oxytocin 10 IU administered once per intravenous injection~Oxytocin: Single IV administration of oxytocin"
11352819|NCT03929367|EG000|Reported Event|Oxytocin (Pitocin®), 10 IU|This was a one day, open-label, single-dose study of intravenous oxytocin for the purpose of estimating plasma pharmacokinetic model parameters in adult men and women. Blood pressure, heart and respiratory rate, and oxyhemoglobin saturation were recorded prior to and at intervals following administration of oxytocin. In addition, subjects were informed to indicate if they had any subjective symptoms.
11352820|NCT03928522|BG000|Baseline|Pre-mixed Tobramycin|"patients will receive pre-mixed tobramycin cement~pre-mixed tobramycin: this cement is already pre-mixed with tobramycin"
11352821|NCT03928522|BG001|Baseline|Hand Mixed Tobramycin|"patients will receive hand mixed tobramycin cement~hand mixed tobramycin: hand mixed tobramycin into cement"
11352822|NCT03928522|BG002|Baseline|Hand Mixed Vancomycin|"patients will receive hand mixed vancomycin cement~hand mixed vancomycin: hand mixed vancomycin powder into cement"
11352823|NCT03928522|BG003|Baseline|Hand-mixed Vancomycin and Tobramycin|"patients will receive hand mixed vancomycin and tobramycin~hand mixed vancomycin: hand mixed vancomycin powder into cement~hand mixed tobramycin: hand mixed tobramycin into cement"
11352824|NCT03928522|BG004|Baseline|Intr-articular Vancomycin|Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure
11352825|NCT03928522|BG005|Baseline|Total|Total of all reporting groups
11352826|NCT03928522|FG000|Participant Flow|Pre-mixed Tobramycin|"patients will receive pre-mixed tobramycin cement~pre-mixed tobramycin: this cement is already pre-mixed with tobramycin"
11352827|NCT03928522|FG001|Participant Flow|Hand Mixed Tobramycin|"patients will receive hand mixed tobramycin cement~hand mixed tobramycin: hand mixed tobramycin into cement"
11352828|NCT03928522|FG002|Participant Flow|Hand Mixed Vancomycin|"patients will receive hand mixed vancomycin cement~hand mixed vancomycin: hand mixed vancomycin powder into cement"
11352829|NCT03928522|FG003|Participant Flow|Hand-mixed Vancomycin and Tobramycin|"patients will receive hand mixed vancomycin and tobramycin~hand mixed vancomycin: hand mixed vancomycin powder into cement~hand mixed tobramycin: hand mixed tobramycin into cement"
11352830|NCT03928522|FG004|Participant Flow|Intra-articular Vancomycin|Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure
11352831|NCT03928522|OG000|Outcome|Pre-mixed Tobramycin|"patients will receive pre-mixed tobramycin cement~pre-mixed tobramycin: this cement is already pre-mixed with tobramycin"
11352832|NCT03928522|OG001|Outcome|Hand Mixed Tobramycin|"patients will receive hand mixed tobramycin cement~hand mixed tobramycin: hand mixed tobramycin into cement"
11352833|NCT03928522|OG002|Outcome|Hand Mixed Vancomycin|"patients will receive hand mixed vancomycin cement~hand mixed vancomycin: hand mixed vancomycin powder into cement"
11352834|NCT03928522|OG003|Outcome|Hand-mixed Vancomycin and Tobramycin|"patients will receive hand mixed vancomycin and tobramycin~hand mixed vancomycin: hand mixed vancomycin powder into cement~hand mixed tobramycin: hand mixed tobramycin into cement"
11352835|NCT03928522|OG004|Outcome|Intr-articular Vancomycin|Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure
11352836|NCT03928522|EG000|Reported Event|Pre-mixed Tobramycin|"patients will receive pre-mixed tobramycin cement~pre-mixed tobramycin: this cement is already pre-mixed with tobramycin"
11352837|NCT03928522|EG001|Reported Event|Hand Mixed Tobramycin|"patients will receive hand mixed tobramycin cement~hand mixed tobramycin: hand mixed tobramycin into cement"
11352838|NCT03928522|EG002|Reported Event|Hand Mixed Vancomycin|"patients will receive hand mixed vancomycin cement~hand mixed vancomycin: hand mixed vancomycin powder into cement"
11352839|NCT03928522|EG003|Reported Event|Hand-mixed Vancomycin and Tobramycin|"patients will receive hand mixed vancomycin and tobramycin~hand mixed vancomycin: hand mixed vancomycin powder into cement~hand mixed tobramycin: hand mixed tobramycin into cement"
11352840|NCT03928522|EG004|Reported Event|Intra-articular Vancomycin|patients will receive powdered vancomycin into the wound before closure
11230899|NCT02409667|FG003|Participant Flow|Treatment Period 2: Group 3|Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
11230900|NCT02409667|FG004|Participant Flow|Treatment Period 2: Group 4|Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
11230901|NCT02409667|OG000|Outcome|Treatment Period 2: Group 1|Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
11230902|NCT02409667|OG001|Outcome|Treatment Period 2: Group 2|Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
11230903|NCT02409667|OG000|Outcome|Treatment Period 2: Group 3|Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
11230904|NCT02409667|OG001|Outcome|Treatment Period 2: Group 4|Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
11230905|NCT02409667|EG000|Reported Event|Treatment Period 1: All Participants|Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
11230906|NCT02409667|EG001|Reported Event|Treatment Period 2: Group 1|Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
11230907|NCT02409667|EG002|Reported Event|Treatment Period 2: Group 2|Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
11230908|NCT02409667|EG003|Reported Event|Treatment Period 2: Group 3|Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
11230909|NCT02409667|EG004|Reported Event|Treatment Period 2: Group 4|Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
11230910|NCT02409680|BG000|Baseline|Intervention Arm|Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA.
11230911|NCT02409680|BG001|Baseline|Placebo Arm|Identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery.
11230912|NCT02409680|BG002|Baseline|Total|Total of all reporting groups
11230913|NCT02409680|FG000|Participant Flow|Intervention Arm|Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA.
11230914|NCT02409680|FG001|Participant Flow|Placebo Arm|Identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery.
11230915|NCT02409680|OG000|Outcome|Intervention Arm|Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA.
11230916|NCT02409680|OG001|Outcome|Placebo Arm|Identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery.
11230917|NCT02409680|EG000|Reported Event|Intervention Arm|Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA.
11230918|NCT02409680|EG001|Reported Event|Placebo Arm|Identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery.
11230919|NCT02409719|BG000|Baseline|Control - Verbal Information and Booklet|"Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.~Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the"
11230920|NCT02409719|BG001|Baseline|Study - Verbal Information, Booklet & Schedule.|"Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed~Schedule: Illustrative daily planner to point the day that the exercise was performed~Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the"
11230921|NCT02409719|BG002|Baseline|Total|Total of all reporting groups
11230922|NCT02409719|FG000|Participant Flow|Control - Verbal Information and Booklet|"Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.~Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the"
11352841|NCT03910439|BG000|Baseline|1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy|"Avelumab 800 mg IV every two weeks in combination with radiation therapy~Avelumab: Avelumab 800 mg intravenous (IV) over 60 minutes (+/- 20 minutes) on days 1 and 15 of each 28-day cycle~External beam radiotherapy: 5 gray (Gy) per fraction will be delivered on 5 consecutive treatment days for a total dose 25 Gy"
11352842|NCT03910439|FG000|Participant Flow|1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy|"Avelumab 800 mg IV every two weeks in combination with radiation therapy~Avelumab: Avelumab 800 mg intravenous (IV) over 60 minutes (+/- 20 minutes) on days 1 and 15 of each 28-day cycle~External beam radiotherapy: 5 gray (Gy) per fraction will be delivered on 5 consecutive treatment days for a total dose 25 Gy"
11352843|NCT03910439|OG000|Outcome|1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy|"Avelumab 800 mg IV every two weeks in combination with radiation therapy~Avelumab: Avelumab 800 mg intravenous (IV) over 60 minutes (+/- 20 minutes) on days 1 and 15 of each 28-day cycle~External beam radiotherapy: 5 gray (Gy) per fraction will be delivered on 5 consecutive treatment days for a total dose 25 Gy"
11352844|NCT03910439|OG000|Outcome|Grade 1|Grade 1 is mild.
11352845|NCT03910439|OG001|Outcome|Grade 2|Grade 2 is moderate.
11352846|NCT03910439|OG002|Outcome|Grade 3|Grade 3 is severe or medically significant.
11352847|NCT03910439|EG000|Reported Event|1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy|"Avelumab 800 mg IV every two weeks in combination with radiation therapy~Avelumab: Avelumab 800 mg intravenous (IV) over 60 minutes (+/- 20 minutes) on days 1 and 15 of each 28-day cycle~External beam radiotherapy: 5 gray (Gy) per fraction will be delivered on 5 consecutive treatment days for a total dose 25 Gy"
11352848|NCT03907241|BG000|Baseline|Age >=2 to <6|Octanorm 16.5%
11352849|NCT03907241|BG001|Baseline|Age >=6 to <12|Octanorm 16.5%
11352850|NCT03907241|BG002|Baseline|Age >=12 to <17|Octanorm 16.5%
11352851|NCT03907241|BG003|Baseline|Age >=17 to <=75|Octanorm 16.5%
11352852|NCT03907241|BG004|Baseline|Total|Total of all reporting groups
11352853|NCT03907241|FG000|Participant Flow|Octanorm 16.5%|"octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration.~Octanorm 16.5%: Human normal immunoglobulin"
11352854|NCT03907241|OG000|Outcome|Age >=2 to <6|Octanorm 16.5%
11352855|NCT03907241|OG001|Outcome|Age >=6 to <12|Octanorm 16.5%
11352856|NCT03907241|OG002|Outcome|Age >=12 to <17|Octanorm 16.5%
11352857|NCT03907241|OG003|Outcome|Age >=17 to <=75|Octanorm 16.5%
11352858|NCT03907241|OG000|Outcome|Age >=12 to <17|Octanorm 16.5%
11352859|NCT03907241|OG001|Outcome|Age >=17 to <=75|Octanorm 16.5%
11352860|NCT03907241|OG000|Outcome|Age >=2 to <6|Age >=2 to <6
11352861|NCT03907241|OG001|Outcome|Age >=6 to <12|Age >=6 to <12
11352862|NCT03907241|OG002|Outcome|Age >=12 to <17|Age >=12 to <17
11352863|NCT03907241|EG000|Reported Event|Age >=2 to <6|Octanorm 16.5%
11352864|NCT03907241|EG001|Reported Event|Age >=6 to <12|Octanorm 16.5%
11352865|NCT03907241|EG002|Reported Event|Age >=12 to <17|Octanorm 16.5%
11352866|NCT03907241|EG003|Reported Event|Age >=17 to <=75|Octanorm 16.5%
11352867|NCT03927950|BG000|Baseline|Escitalopram|Escitalopram 10-20mg; an open-label, placebo not controlled trial in a naturalistic setting
11352868|NCT03927950|FG000|Participant Flow|Escitalopram Bupropion Open-label|Escitalopram 10-20mg and Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
11352869|NCT03927950|OG000|Outcome|Escitalopram|Escitalopram 10-20mg; an open-label, placebo not controlled trial in a naturalistic setting
11352870|NCT03927950|OG000|Outcome|Escitalopram Bupropion Open-label|Escitalopram 10-20mg and Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
11352871|NCT03927950|EG000|Reported Event|Escitalopram Bupropion Open-label|Escitalopram 10-20mg Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
11352872|NCT03927781|BG000|Baseline|Pregabalin 300mg|"300mg pregabalin, PO, once, 1 hr before surgery~Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery"
11352873|NCT03927781|FG000|Participant Flow|Pregabalin 300mg|"300mg pregabalin, PO, once, 1 hr before surgery~Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery"
11352874|NCT03927781|OG000|Outcome|Pregabalin 300mg|"300mg pregabalin, PO, once, 1 hr before surgery~Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery"
11352875|NCT03927781|EG000|Reported Event|Pregabalin 300mg|"300mg pregabalin, PO, once, 1 hr before surgery~Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery"
11352876|NCT03927209|BG000|Baseline|BI 1467335 10 Milligram (mg)|Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
11352877|NCT03927209|BG001|Baseline|BI 1467335 3 Milligram (mg)|Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
11352878|NCT03927209|BG002|Baseline|Total|Total of all reporting groups
11352879|NCT03927209|FG000|Participant Flow|BI 1467335 10 Milligram (mg)|Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
11352880|NCT03927209|FG001|Participant Flow|BI 1467335 3 Milligram (mg)|Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
11352881|NCT03927209|OG000|Outcome|BI 1467335 10 Milligram (mg)|Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
11352882|NCT03927209|OG001|Outcome|BI 1467335 3 Milligram (mg)|Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
11352883|NCT03927209|OG000|Outcome|BI 1467335 3 Milligram (mg)|Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
11352884|NCT03927209|EG000|Reported Event|BI 1467335 10 Milligram (mg)|Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
11352885|NCT03927209|EG001|Reported Event|BI 1467335 3 Milligram (mg)|Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
11352886|NCT03927209|EG002|Reported Event|Total on Treatment|Total of the over all on-treatment phases of BI 1467335.
11352887|NCT03920670|BG000|Baseline|Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand|"TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand~TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured."
11352888|NCT03920670|BG001|Baseline|ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand|"ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand~TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured."
11352889|NCT03920670|BG002|Baseline|Total|Total of all reporting groups
11352890|NCT03920670|FG000|Participant Flow|Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand|"TetraGraph was placed on dominant hand, ToFscan (TS) was placed on non-dominant hand~TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured."
11352891|NCT03920670|FG001|Participant Flow|ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand|"ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand~TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured."
11352892|NCT03920670|OG000|Outcome|Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand|"TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand~TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~Dominant arm Train-of-Four Ratios collected for analysis"
11352893|NCT03920670|OG001|Outcome|ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand|"ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand~TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~Dominant arm Train-of-Four Ratios collected for analysis"
11352894|NCT03920670|EG000|Reported Event|Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand|"TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand~TetraGraph (TG): AMG and EMG neuromuscular blockade monitoring. The TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~ToFscan (TS): Neuromuscular transmission monitor. A measure of muscle relaxation on an anesthetized subjects. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured."
11352895|NCT03920670|EG001|Reported Event|ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand|"ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand~TetraGraph (TG): AMG and EMG neuromuscular blockade monitoring. The TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.~ToFscan (TS): Neuromuscular transmission monitor. A measure of muscle relaxation on an anesthetized subjects. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured."
11352896|NCT03919422|BG000|Baseline|IC Group|"Interscalene brachial plexus-Cervical plexus~interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus."
11352897|NCT03919422|BG001|Baseline|ICTP Group|"Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade~T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).~interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus."
11352898|NCT03919422|BG002|Baseline|Total|Total of all reporting groups
11352899|NCT03919422|FG000|Participant Flow|IC Group|"Interscalene brachial plexus-Cervical plexus~interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus."
11352900|NCT03919422|FG001|Participant Flow|ICTP Group|"Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade~T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).~interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus."
11352901|NCT03919422|OG000|Outcome|IC Group|"Interscalene brachial plexus-Cervical plexus~interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus."
11352902|NCT03919422|OG001|Outcome|ICTP Group|"Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade~T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).~interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus."
11352903|NCT03919422|EG000|Reported Event|IC Group|"Interscalene brachial plexus-Cervical plexus~interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus."
11230923|NCT02409719|FG001|Participant Flow|Study - Verbal Information, Booklet & Schedule.|"Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed~Schedule: Illustrative daily planner to point the day that the exercise was performed~Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the"
11230924|NCT02409719|OG000|Outcome|Control - Verbal Information and Booklet|"Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.~Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the"
11230925|NCT02409719|OG001|Outcome|Study - Verbal Information, Booklet & Schedule.|"Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed~Schedule: Illustrative daily planner to point the day that the exercise was performed~Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the"
11230926|NCT02409719|EG000|Reported Event|Control - Verbal Information and Booklet|"Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.~Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the"
11230927|NCT02409719|EG001|Reported Event|Study - Verbal Information, Booklet & Schedule.|"Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed~Schedule: Illustrative daily planner to point the day that the exercise was performed~Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the"
11230928|NCT02409732|BG000|Baseline|Photodynamic Therapy With Blue Light|Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
11230929|NCT02409732|FG000|Participant Flow|Photodynamic Therapy With Blue Light|Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
11230930|NCT02409732|OG000|Outcome|Photodynamic Therapy With Blue Light|Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
11230931|NCT02409732|OG000|Outcome|Photodynamic Therapy With Blue Light|Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments
11230932|NCT02409732|EG000|Reported Event|Photodynamic Therapy With Blue Light|Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments
11230933|NCT02409784|BG000|Baseline|Ketogenic Diet|"TEP study following a 4 day ketogenic diet (KD)~Intervention 1: Pre-KD = Participants did a TEP before starting a 4 days ketogenic diet Intervention 2: Post-KD = Participants did a TEP after 4 days of ketogenic diet"
11230934|NCT02409784|FG000|Participant Flow|Ketogenic Diet|"TEP study following a 4 day ketogenic diet (KD), consisting of a classic 4:1 KD (4:1 lipid to carbohydrate + protein ratio) in the form of liquid meal (water, cream, MCT oil, liquid egg white, flavor) and taken in 3 separates meal.~Intervention 1: Pre-KD = Participants did a TEP before starting the 4 days ketogenic diet~Intervention 2 : Post-KD = Participants did a TEP after the 4 days ketogenic diet"
11230935|NCT02409784|OG000|Outcome|Ketogenic Diet|"TEP study with a 4 days ketogenic diet~Ketogenic diet: 4 days 4:1 (lipids:protein/carbohydrates) ketogenic diet~Intervention 1: Pre-KD = Participants did a TEP before starting 4 days of ketogenic diet~Intervention 2: Post-KD = Participants did a TEP after 4 days of ketogenic diet"
11230936|NCT02409784|OG000|Outcome|Ketogenic Diet|"TEP study with a 4 days ketogenic diet~Ketogenic diet: 4 days 4:1 (lipids:protein/carbohydrates) ketogenic diet"
11230937|NCT02409784|EG000|Reported Event|Ketogenic Diet|"TEP study with a 4 days ketogenic diet~Ketogenic diet: 4 days 4:1 (lipids:protein/carbohydrates) ketogenic diet~Intervention 1: Pre-KD = Participants did a TEP before starting a 4 days ketogenic diet Intervention 2: Post-KD = Participants did a TEP after 4 days of ketogenic diet"
11230938|NCT02409914|BG000|Baseline|POLYCYSTIC OVARY SYNDROME (PCOS)|"Women with PCOS diagnosed during a clinical examination using the Rotterdam criteria.~PET and MRI exams: FDG PET scan and T1-weight MRI were obtained within an average time frame of 3 weeks."
11230939|NCT02409914|FG000|Participant Flow|POLYCYSTIC OVARY SYNDROME (PCOS)|Women with PCOS. FDG PET scan,T1-weight MRI and a blood sample for the evaluation of insulin resistance were obtained within an average time frame of 3 weeks.
11230940|NCT02409914|OG000|Outcome|Polycystic Ovary Syndrome (PCOS)|Women with PCOS.
11230941|NCT02409914|EG000|Reported Event|POLYCYSTIC OVARY SYNDROME (PCOS)|"Women with PCOS diagnosed during a clinical examination using the Rotterdam criteria.~PET and MRI exams: FDG PET scan and T1-weight MRI were obtained within an average time frame of 3 weeks."
11230942|NCT02409927|BG000|Baseline|Healthy|Participants involved in the project had seven metabolic study day to do : control day (no supplement), MCT oil 10,20 or 30 g, and MCT homogenate 10, 20 or 30 g. They were taking the supplement with a breakfast and there was blood sampling every 30 minutes.t
11352904|NCT03919422|EG001|Reported Event|ICTP Group|"Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade~T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).~interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus."
11352905|NCT03907579|BG000|Baseline|Inflatable Colon Educational Module|"Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.~Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening."
11352906|NCT03907579|FG000|Participant Flow|Inflatable Colon Educational Module|"Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.~Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening."
11352907|NCT03907579|OG000|Outcome|Inflatable Colon Educational Module|"Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.~Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening."
11352908|NCT03907579|EG000|Reported Event|Inflatable Colon Educational Module|"Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.~Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening."
11352909|NCT03898063|BG000|Baseline|Control|"participants will receive a standard-of-care brochure detailing HIV status disclosure.~HIV pamphlet on disclosure: A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure"
11352910|NCT03898063|BG001|Baseline|Intervention: 90 DAYS Film|"participants will watch the film, 90 DAYS~90 DAYS film: the intervention conditions include exposure to a film, 90 DAYS (approx 20 minutes long), an entertainment film detailing a woman's decision to tell her romantic partner that she is HIV-positive."
11167537|NCT01980095|FG000|Participant Flow|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg"
11167538|NCT01980095|FG001|Participant Flow|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
11167539|NCT01980095|OG000|Outcome|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of:~Rifabutin 150 mg~Amoxicillin 3000 mg~Omeprazole 120 mg"
11352911|NCT03898063|BG002|Baseline|Total|Total of all reporting groups
11352912|NCT03898063|FG000|Participant Flow|Control|"participants will receive a standard-of-care brochure detailing HIV status disclosure.~HIV pamphlet on disclosure: A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure"
11167540|NCT01980095|OG001|Outcome|Placebo|"Capsules that look like the RHB-105 product but contain no active ingredient.~Placebo: Subjects will take 4 placebo capsules every 8 hours with food for 14 days."
11167541|NCT01980095|OG000|Outcome|Placebo Subjects|These patients failed h.pylori eradication on study drug (placebo) and were subsequently treated with standard of care therapy as per the investigator
11167542|NCT01980095|OG001|Outcome|Active Drug Eradication Failure Subjects|These patients failed h.pylori eradication on study drug (active) and were subsequently treated with standard of care therapy as per the investigator.
11167543|NCT01980095|EG000|Reported Event|RHB-105|RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.
11167544|NCT01980095|EG001|Reported Event|Placebo|Identical capsules that look like the RHB-105 product but contain no active ingredient.
11167545|NCT01980485|BG000|Baseline|Feedback on Lung Age and Exhaled Carbon Monoxide|"Lung Age feedback and exhaled carbon monoxide: In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a normal FEV-1, the intervention will focus on their exhaled carbon-monoxide.~If their lung age is greater than their chronological age, they will be given their lung age in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation.~Those in the Intervention Group will have their exhaled carbon-monoxide (CO) result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided w"
11352913|NCT03898063|FG001|Participant Flow|Intervention: 90 DAYS Film|"participants will watch the film, 90 DAYS~90 DAYS film: the intervention conditions include exposure to a film, 90 DAYS (approx 20 minutes long), an entertainment film detailing a woman's decision to tell her romantic partner that she is HIV-positive."
11352914|NCT03898063|OG000|Outcome|Control|The participants in the control arm reviewed a brochure. After completing the pre-test, the randomize feature in Qualtrics, randomly assigned participants to one of two arms: control (brochure) or treatment (90 DAYS narrative).
11352915|NCT03898063|OG001|Outcome|Treatment|The participants in the treatment arm viewed the 90 DAYS entertainment education film. After completing the pre-test, the randomize feature in Qualtrics, randomly assigned participants to one of two study arms: control (brochure) or treatment (90 DAYS film).
11352916|NCT03898063|EG000|Reported Event|Control|"participants will receive a standard-of-care brochure detailing HIV status disclosure.~HIV pamphlet on disclosure: A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure"
11352917|NCT03898063|EG001|Reported Event|Intervention: 90 DAYS Film|"participants will watch the film, 90 DAYS~90 DAYS film: the intervention conditions include exposure to a film, 90 DAYS (approx 20 minutes long), an entertainment film detailing a woman's decision to tell her romantic partner that she is HIV-positive."
11352918|NCT03895307|BG000|Baseline|Kinesio Taping|"two 15 cm I type kinesio tape applied longitudinally~kinesio tape: two 15 cm I type kinesio tape applied longitudinally"
11352919|NCT03895307|BG001|Baseline|Sham Kinesio Taping|"two 15 cm I type kinesio tape applied longitudinally but without stretching~kinesio tape: two 15 cm I type kinesio tape applied longitudinally"
11352920|NCT03895307|BG002|Baseline|Local Anesthetic|"18-20 cc %0.5 lidocaine subcutaneous injection~local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection"
11352921|NCT03895307|BG003|Baseline|Local Serum Physiologic|"18-20 cc % 0.09 NaCl subcutaneous injection~local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection"
11352922|NCT03895307|BG004|Baseline|Total|Total of all reporting groups
11167546|NCT01980485|BG001|Baseline|No Lung Age Feedback|"Those allocated to the control group will simply be informed of their scores on the spirometry.~No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry."
11167547|NCT01980485|BG002|Baseline|Total|Total of all reporting groups
11352923|NCT03895307|FG000|Participant Flow|Kinesio Taping|"two 15 cm I type kinesio tape applied longitudinally~kinesio tape: two 15 cm I type kinesio tape applied longitudinally"
11352924|NCT03895307|FG001|Participant Flow|Sham Kinesio Taping|"two 15 cm I type kinesio tape applied longitudinally but without stretching~kinesio tape: two 15 cm I type kinesio tape applied longitudinally"
11352925|NCT03895307|FG002|Participant Flow|Local Anesthetic|"18-20 cc %0.5 lidocaine subcutaneous injection~local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection"
11352926|NCT03895307|FG003|Participant Flow|Local Serum Physiologic|"18-20 cc % 0.09 NaCl subcutaneous injection~local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection"
11352927|NCT03895307|OG000|Outcome|Kinesio Taping|"two 15 cm I type kinesio tape applied longitudinally~kinesio tape: two 15 cm I type kinesio tape applied longitudinally"
11352928|NCT03895307|OG001|Outcome|Sham Kinesio Taping|"two 15 cm I type kinesio tape applied longitudinally but without stretching~kinesio tape: two 15 cm I type kinesio tape applied longitudinally"
11352929|NCT03895307|OG002|Outcome|Local Anesthetic|"18-20 cc %0.5 lidocaine subcutaneous injection~local anesthetic: local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection"
11352930|NCT03895307|OG003|Outcome|Local Serum Physiologic|"18-20 cc % 0.09 NaCl subcutaneous injection~local serum physiologic: serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection"
11352931|NCT03895307|EG000|Reported Event|Kinesio Tape|two 15 cm I type kinesio tape applied longitudinally
11352932|NCT03895307|EG001|Reported Event|Sham Kinesio Taping|two 15 cm I type kinesio tape applied longitudinally but without stretching
11352933|NCT03895307|EG002|Reported Event|Local Anesthetic|18-20 cc %0.5 lidocaine subcutaneous injection
11352934|NCT03895307|EG003|Reported Event|Local Serum Physiologic|18-20 cc % 0.09 NaCl subcutaneous injection
11352935|NCT03926208|BG000|Baseline|Control|"Subjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold.~Clorhexadine scrub: Clorhexadine scrub (standard of care)."
11352936|NCT03926208|BG001|Baseline|Intervention|"In addition to the standard chlorhexadine prep of the foot prior to surgery, subjects in this group will also receive a betadine soak and scrub of the foot, and a cotton swab will be collected from the hallux nail fold.~Soak and Scrub: Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care)."
11352937|NCT03926208|BG002|Baseline|Total|Total of all reporting groups
11352938|NCT03926208|FG000|Participant Flow|Control|"Subjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold.~Clorhexadine scrub: Clorhexadine scrub (standard of care)."
11352939|NCT03926208|FG001|Participant Flow|Intervention|"In addition to the standard chlorhexadine prep of the foot prior to surgery, subjects in this group will also receive a betadine soak and scrub of the foot, and a cotton swab will be collected from the hallux nail fold.~Soak and Scrub: Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care)."
11352940|NCT03926208|OG000|Outcome|Control|"Subjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold.~Clorhexadine scrub: Clorhexadine scrub (standard of care)."
11352941|NCT03926208|OG001|Outcome|Intervention|"In addition to the standard chlorhexadine prep of the foot prior to surgery, subjects in this group will also receive a betadine soak and scrub of the foot, and a cotton swab will be collected from the hallux nail fold.~Soak and Scrub: Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care)."
11352942|NCT03926208|EG000|Reported Event|Control|"Subjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold.~Clorhexadine scrub: Clorhexadine scrub (standard of care)."
11352943|NCT03926208|EG001|Reported Event|Intervention|"In addition to the standard chlorhexadine prep of the foot prior to surgery, subjects in this group will also receive a betadine soak and scrub of the foot, and a cotton swab will be collected from the hallux nail fold.~Soak and Scrub: Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care)."
11352944|NCT03926065|BG000|Baseline|Entire Study Population|Enrolled participants who completed the study
11352945|NCT03926065|FG000|Participant Flow|St Pal/Lg PS, En Pal/St PS, St Pal/St PS, En Pal/Lg PS|Participants who received the meals in the order of Plain Vegetables served in 200% Portion Size first, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 100% Portion Size, then Enhanced Vegetables served in 200% Portion Size
11352946|NCT03926065|FG001|Participant Flow|En Pal/Lg PS, St Pal/St PS, En Pal/St PS, St Pal/Lg PS|Participants who received the meals in the order of Enhanced Vegetables served in 200% Portion Size first, then Plain Vegetables served in 100% Portion Size, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 200% Portion Size
11352947|NCT03926065|FG002|Participant Flow|En Pal/St PS, En Pal/Lg PS, St Pal/Lg PS, St Pal/St PS|Participants who received the meals in the order of Enhanced Vegetables served in 100% Portion Size first, then Enhanced Vegetables served in 200% Portion Size, then Plain Vegetables served in 200% Portion Size, then Plain Vegetables served in 100% Portion Size
11352948|NCT03926065|FG003|Participant Flow|St Pal/St PS, St Pal/Lg PS, En Pal/Lg PS, En Pal/St PS|Participants who received the meals in the order of Plain Vegetables served in 100% Portion Size first, then Plain Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 100% Portion Size
11352949|NCT03926065|FG004|Participant Flow|En Pal/Lg PS, St Pal/Lg PS, En Pal/St PS, St Pal/St PS|Participants who received the meals in the order of Enhanced Vegetables served in 200% Portion Size first, then Plain Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 100% Portion Size
11352950|NCT03926065|OG000|Outcome|Standard Palatability and Standard Portion Size|"Vegetables with Standard Palatability and Standard Portion Size~Plain Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables"
11352951|NCT03926065|OG001|Outcome|Standard Palatability and Larger Portion Size|"Vegetables with Standard Palatability and Larger Portion Size~Plain Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables"
11352952|NCT03926065|OG002|Outcome|Enhanced Palatability and Standard Portion Size|"Vegetables with Enhanced Palatability and Standard Portion Size~Enhanced Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables"
11352953|NCT03926065|OG003|Outcome|Enhanced Palatability and Larger Portion Size|"Vegetables with Enhanced Palatability and Larger Portion Size~Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables"
11352954|NCT03926065|EG000|Reported Event|Standard Palatability and Standard Portion Size|"Vegetables with Standard Palatability and Standard Portion Size~Plain Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables"
11352955|NCT03926065|EG001|Reported Event|Standard Palatability and Larger Portion Size|"Vegetables with Standard Palatability and Larger Portion Size~Plain Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables"
11352956|NCT03926065|EG002|Reported Event|Enhanced Palatability and Standard Portion Size|"Vegetables with Enhanced Palatability and Standard Portion Size~Enhanced Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables"
11352957|NCT03926065|EG003|Reported Event|Enhanced Palatability and Larger Portion Size|"Vegetables with Enhanced Palatability and Larger Portion Size~Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables"
11352958|NCT03909100|BG000|Baseline|CoolSculpting® System|Participants received up to two CoolSculpting® treatment sessions for the abdomen, flanks or both 8 weeks apart. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.
11352959|NCT03909100|FG000|Participant Flow|CoolSculpting® System|Participants received up to two CoolSculpting® treatment sessions for the abdomen, flanks or both 8 weeks apart. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.
11352960|NCT03909100|OG000|Outcome|CoolSculpting® System|Participants received up to two CoolSculpting® treatment sessions for the abdomen, flanks or both 8 weeks apart. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.
11352961|NCT03909100|OG000|Outcome|CoolSculpting®: Treatment Session 1|Participants who received one CoolSculpting® treatment session for the abdomen, flanks or both. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.
11352962|NCT03909100|OG001|Outcome|CoolSculpting®: Treatment Session 2|Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.
11352963|NCT03909100|EG000|Reported Event|CoolSculpting®: Treatment Session 1|Participants who received one CoolSculpting® treatment session for the abdomen, flanks or both. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.
11352964|NCT03909100|EG001|Reported Event|CoolSculpting®: Treatment Session 2|Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.
11352965|NCT03905642|BG000|Baseline|560 mg Arikayce™|"Subjects in this cohort will receive 560 mg of Arikayce™~Arikayce™: Amikacin (aminoglycoside) in a liposomal formulation."
11352966|NCT03905642|FG000|Participant Flow|560 mg Arikayce™|"Subjects in this cohort will receive 560 mg of Arikayce™~Arikayce™: Amikacin (aminoglycoside) in a liposomal formulation."
11352967|NCT03905642|OG000|Outcome|560 mg Arikayce™|"Subjects in this cohort will receive 560 mg of Arikayce™~Arikayce™: Amikacin (aminoglycoside) in a liposomal formulation."
11352968|NCT03905642|EG000|Reported Event|560 mg Arikayce™|"Subjects in this cohort will receive 560 mg of Arikayce™~Arikayce™: Amikacin (aminoglycoside) in a liposomal formulation."
11352969|NCT03892889|BG000|Baseline|Abilify MyCite®|Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
11352970|NCT03892889|FG000|Participant Flow|Abilify MyCite®|Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
11167548|NCT01980485|FG000|Participant Flow|Feedback on Lung Age and Exhaled Carbon Monoxide|"Lung Age feedback and exhaled carbon monoxide: In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a normal FEV-1, the intervention will focus on their exhaled carbon-monoxide.~If their lung age is greater than their chronological age, they will be given their lung age in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation.~Those in the Intervention Group will have their exhaled carbon-monoxide (CO) result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided w"
11167549|NCT01980485|FG001|Participant Flow|No Lung Age Feedback|"Those allocated to the control group will simply be informed of their scores on the spirometry.~No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry."
11352971|NCT03892889|OG000|Outcome|Abilify MyCite®|Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
11352972|NCT03892889|EG000|Reported Event|Abilify MyCite®|Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
11352973|NCT03921723|BG000|Baseline|Prototype A/DTG Reference/Prototype B|Participants were administered a single oral dose of 5 milligrams (mg) per milliliter (mL) DTG sodium oral suspension (Prototype A), for a total of 10 mg in Period 1 followed by a single oral dose of two 5 mg DTG dispersible tablets dispersed in water (DTG reference) in Period 2. Participants further received a single oral dose of 2 mg/mL DTG sodium oral liquid (Prototype B) in Period 3, also receiving a total dose of 10 mg. There was a minimum washout of 7 days between doses.
11352974|NCT03921723|FG000|Participant Flow|Prototype A/DTG Reference/Prototype B|Participants were administered a single oral dose of 5 milligrams (mg) per milliliter (mL) DTG sodium oral suspension (Prototype A), for a total of 10 mg in Period 1 followed by a single oral dose of two 5 mg DTG dispersible tablets dispersed in water (DTG reference) in Period 2. Participants further received a single oral dose of 2 mg/mL DTG sodium oral liquid (Prototype B) in Period 3, also receiving a total dose of 10 mg. There was a minimum washout of 7 days between doses.
11352975|NCT03921723|OG000|Outcome|Prototype A|Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)
11352976|NCT03921723|OG001|Outcome|Prototype B|Participants received a single oral dose of Prototype B (2 mg/mL DTG [as DTG Sodium in glycerol vehicle] oral liquid)
11352977|NCT03921723|OG002|Outcome|DTG Reference|Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
11352978|NCT03921723|EG000|Reported Event|Prototype A|Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)
11352979|NCT03921723|EG001|Reported Event|Prototype B|Participants received a single oral dose of Prototype B (2 mg/mL DTG [as DTG Sodium in glycerol vehicle] oral liquid)
11352980|NCT03921723|EG002|Reported Event|DTG Reference|Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
11352981|NCT03921190|BG000|Baseline|Open-mouth|"Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open~Local anesthesia: Patients scheduled for a dental procedure that requires local anesthesia will be given the injection using two 2 techniques; an open-mouth and closed-mouth techniques"
11352982|NCT03921190|BG001|Baseline|Closed-mouth|"Patients receiving MBIA using a closed-mouth technique~Local anesthesia: Patients scheduled for a dental procedure that requires local anesthesia will be given the injection using two 2 techniques; an open-mouth and closed-mouth techniques"
11352983|NCT03921190|BG002|Baseline|Total|Total of all reporting groups
11352984|NCT03921190|FG000|Participant Flow|Open-mouth|"Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open~Local anesthesia: Patients scheduled for a dental procedure that requires local anesthesia will be given the injection using two 2 techniques; an open-mouth and closed-mouth techniques"
11352985|NCT03921190|FG001|Participant Flow|Closed-mouth|"Patients receiving MBIA using a closed-mouth technique~Local anesthesia: Patients scheduled for a dental procedure that requires local anesthesia will be given the injection using two 2 techniques; an open-mouth and closed-mouth techniques"
11352986|NCT03921190|OG000|Outcome|Open-mouth|Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open
11352987|NCT03921190|OG001|Outcome|Closed-mouth|Patients receiving MBIA using a closed-mouth technique
11352988|NCT03921190|OG000|Outcome|Open-mouth|Number of dentists who preferred the open-mouth technique for maxillary buccal infiltration anesthesia
11352989|NCT03921190|OG001|Outcome|Closed-mouth|Number of dentists who preferred the closed-mouth technique for maxillary buccal infiltration anesthesia
11352990|NCT03921190|EG000|Reported Event|Open-mouth|Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open
11352991|NCT03921190|EG001|Reported Event|Closed-mouth|Patients receiving MBIA using a closed-mouth technique
11352992|NCT03920865|BG000|Baseline|Mild Hepatic Impairment|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours in Part 1 of the study.
11352993|NCT03920865|BG001|Baseline|Moderate Hepatic Impairment|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours in Part 2 of the study.
11352994|NCT03920865|BG002|Baseline|Normal Hepatic Function|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours. Two normal function participants were matched as controls for mild hepatic impairment participants in Part 1 only; likewise, two normal function participants were matched to moderate hepatic impairment participants in Part 2 only. Six of the normal function participants were matched to mild hepatic impairment participants in Part 1 and also to moderate impairment participants in Part 2.
11352995|NCT03920865|BG003|Baseline|Total|Total of all reporting groups
11352996|NCT03920865|FG000|Participant Flow|Mild Hepatic Impairment|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours in Part 1 of the study.
11352997|NCT03920865|FG001|Participant Flow|Moderate Hepatic Impairment|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours in Part 2 of the study.
11352998|NCT03920865|FG002|Participant Flow|Normal Hepatic Function|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours. Two normal function participants were matched as controls for mild hepatic impairment participants in Part 1 only; likewise, two normal function participants were matched to moderate hepatic impairment participants in Part 2 only. Six of the normal function participants were matched to mild hepatic impairment participants in Part 1 and also to moderate impairment participants in Part 2.
11352999|NCT03920865|OG000|Outcome|Risdiplam - Mild Hepatic Impairment|Participants with mild hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353000|NCT03920865|OG001|Outcome|Risdiplam - Normal Hepatic Function|Participants with normal hepatic function received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353001|NCT03920865|OG002|Outcome|Risdiplam M1 Metabolite - Mild Hepatic Impairment|Participants with mild hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353002|NCT03920865|OG003|Outcome|Risdiplam M1 Metabolite - Normal Hepatic Function|Participants with normal hepatic function received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353003|NCT03920865|OG000|Outcome|Risdiplam - Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353004|NCT03920865|OG002|Outcome|Risdiplam M1 Metabolite - Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353005|NCT03920865|OG000|Outcome|Risdiplam M1 Metabolite - Mild Hepatic Impairment|Participants with mild hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353006|NCT03920865|OG001|Outcome|Risdiplam M1 Metabolite - Normal Hepatic Function|Participants with normal hepatic function received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353007|NCT03920865|OG000|Outcome|Risdiplam - Moderate Hepatic Impairment|Participants with mild hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353008|NCT03920865|OG000|Outcome|Risdiplam M1 Metabolite - Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353009|NCT03920865|OG000|Outcome|Part 1|Participants with mild hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353010|NCT03920865|OG001|Outcome|Part 2|Participants with moderate hepatic impairment received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353011|NCT03920865|OG002|Outcome|Normal Hepatic Function Participants|Participants with normal hepatic function received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours.
11353012|NCT03920865|EG000|Reported Event|Mild Hepatic Impairment|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours in Part 1 of the study.
11353013|NCT03920865|EG001|Reported Event|Moderate Hepatic Impairment|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours in Part 2 of the study.
11353014|NCT03920865|EG002|Reported Event|Normal Hepatic Function|All participants received a single dose of 5 mg risdiplam orally as a drinking solution on Day 1 after an overnight fast of at least 8 hours. Two normal function participants were matched as controls for mild hepatic impairment participants in Part 1 only; likewise, two normal function participants were matched to moderate hepatic impairment participants in Part 2 only. Six of the normal function participants were matched to mild hepatic impairment participants in Part 1 and also to moderate impairment participants in Part 2.
11353015|NCT03918239|BG000|Baseline|SHP643 Prefilled Syringe (PFS)|Participants received 300 milligram (mg) of SHP643 PFS Subcutaneous (SC) injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5).
11353016|NCT03918239|BG001|Baseline|SHP643 Autoinjector (AI)|Participants received 300 mg of SHP643 AI SC injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5).
11353017|NCT03918239|BG002|Baseline|Total|Total of all reporting groups
11353018|NCT03918239|FG000|Participant Flow|SHP643 Prefilled Syringe (PFS)|Participants received 300 milligram (mg) of SHP643 PFS Subcutaneous (SC) injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5).
11353019|NCT03918239|FG001|Participant Flow|SHP643 Autoinjector (AI)|Participants received 300 mg of SHP643 AI SC injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5).
11353020|NCT03918239|OG000|Outcome|SHP643 Prefilled Syringe (PFS)|Participants received 300 milligram (mg) of SHP643 PFS Subcutaneous (SC) injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5).
11353021|NCT03918239|OG001|Outcome|SHP643 Autoinjector (AI)|Participants received 300 mg of SHP643 AI SC injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5).
11353022|NCT03918239|EG000|Reported Event|SHP643 Prefilled Syringe (PFS)|Participants received 300 milligram (mg) of SHP643 PFS Subcutaneous (SC) injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5).
11353023|NCT03918239|EG001|Reported Event|SHP643 Autoinjector (AI)|Participants received 300 mg of SHP643 AI SC injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5).
11353024|NCT03917823|BG000|Baseline|Cryoneurolysis (Active)|"The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.~Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves."
11353025|NCT03917823|BG001|Baseline|Sham|"For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.~Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change."
11353026|NCT03917823|BG002|Baseline|Total|Total of all reporting groups
11353027|NCT03917823|FG000|Participant Flow|Cryoneurolysis (Active)|"The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.~Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves."
11353028|NCT03917823|FG001|Participant Flow|Sham|"For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.~Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change."
11353029|NCT03917823|OG000|Outcome|Cryoneurolysis (Active)|"The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.~Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves."
11353030|NCT03917823|OG001|Outcome|Sham|"For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.~Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change."
11353031|NCT03917823|EG000|Reported Event|Cryoneurolysis (Active)|"The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.~Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves."
11353032|NCT03917823|EG001|Reported Event|Sham|"For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.~Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change."
11353033|NCT03911752|BG000|Baseline|People With Acquired Brain Injury|People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).
11353034|NCT03911752|BG001|Baseline|Partners of People With Acquired Brain Injury|Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
11353035|NCT03911752|BG002|Baseline|Relatives of People With Acquired Brain Injury|Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
11353036|NCT03911752|BG003|Baseline|Total|Total of all reporting groups
11353037|NCT03911752|FG000|Participant Flow|People With Acquired Brain Injury|People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).
11353038|NCT03911752|FG001|Participant Flow|Partners of People With Acquired Brain Injury|Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
11353039|NCT03911752|FG002|Participant Flow|Relatives of People With Acquired Brain Injury|Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
11353040|NCT03911752|OG000|Outcome|People With Acquired Brain Injury|People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).
11230943|NCT02409927|FG000|Participant Flow|Healthy Participant|Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)
11230944|NCT02409927|OG000|Outcome|Healthy Participant|Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)
11230945|NCT02409927|EG000|Reported Event|Healthy Participant|Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)
11230946|NCT02410018|BG000|Baseline|Cohort 1 - Uterine Artery Embolization|"Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization.~OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.~OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent."
11230947|NCT02410018|BG001|Baseline|Cohort 2 - Uterine Artery Embolization|"Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization.~OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.~OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent."
11230948|NCT02410018|BG002|Baseline|Total|Total of all reporting groups
11230949|NCT02410018|FG000|Participant Flow|Cohort 1 - Uterine Artery Embolization|"Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization.~OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.~OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent."
11230950|NCT02410018|FG001|Participant Flow|Cohort 2 - Uterine Artery Embolization|"Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization.~OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.~OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent."
11230951|NCT02410018|OG000|Outcome|Cohort 1 - Uterine Artery Embolization|"Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization.~OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.~OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent."
11230952|NCT02410018|OG001|Outcome|Cohort 2 - Uterine Artery Embolization|"Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization.~OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.~OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent."
11230953|NCT02410018|EG000|Reported Event|Cohort 1 - Uterine Artery Embolization|"Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization.~OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.~OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent."
11230954|NCT02410018|EG001|Reported Event|Cohort 2 - Uterine Artery Embolization|"Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization.~OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.~OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent."
11230955|NCT02410161|BG000|Baseline|Young Group 4 Week ALA Treatment|"Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks~alpha-linolenic acid-rich supplement: each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined)."
11230956|NCT02410161|BG001|Baseline|Old Group 4 Week ALA Treatment|"Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks~alpha-linolenic acid-rich supplement: each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined)."
11230957|NCT02410161|BG002|Baseline|Total|Total of all reporting groups
11230958|NCT02410161|FG000|Participant Flow|Young Group 4 Week ALA Treatment|"Participants will receive the alpha-linolenic acid-rich supplement (ALA) (1000mg 4 times par day) for 4 weeks~alpha-linolenic acid-rich supplement: each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined)."
11230959|NCT02410161|FG001|Participant Flow|Old Group 4 Week ALA Treatment|"Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks~alpha-linolenic acid-rich supplement: each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined)."
11167550|NCT01980485|OG000|Outcome|Feedback on Lung Age and Exhaled Carbon Monoxide|"Lung Age feedback and exhaled carbon monoxide (CO): In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a normal FEV-1, the intervention will focus on their exhaled carbon-monoxide. If their lung age is greater than their chronological age, they will be given their lung age in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation. Those in the Intervention Group will have their CO result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided with a full explanation."
11167551|NCT01980485|OG001|Outcome|No Lung Age Feedback|"Those allocated to the control group will simply be informed of their scores on the spirometry.~No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry."
11167552|NCT01980485|OG000|Outcome|Forever Free Relapse Materials|Participants received forever free relapse materials
11167553|NCT01980485|OG001|Outcome|Surgeon General Brochure|"Participants received A Report from the Surgeon General: How Tobacco Smoke Causes Disease"
11167554|NCT01980485|EG000|Reported Event|Feedback on Lung Age and Exhaled Carbon Monoxide|"Lung Age feedback and exhaled carbon monoxide (CO): In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a normal FEV-1, the intervention will focus on their exhaled carbon-monoxide. If their lung age is greater than their chronological age, they will be given their lung age in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation. Those in the Intervention Group will have their CO result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided with a full explanation."
11167555|NCT01980485|EG001|Reported Event|No Lung Age Feedback|"Those allocated to the control group will simply be informed of their scores on the spirometry.~No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry."
11167556|NCT01980524|BG000|Baseline|All Study Participants|On study day 1 subjects received acipimox 250 mg or placebo at 0 and 180 minutes (randomized, controlled, single blinded); after a wash out period of at least two weeks on study day 2 i) subjects who received acipimox 250 mg on study day 1 were administered placebo at 0 and 180 minutes and ii) subjects who received placebo on study day 1 were administered acipimox 250 mg at 0 and 180 minutes (randomized, controlled, single blinded).
11167557|NCT01980524|FG000|Participant Flow|Acipimox First|Participants received acipimox 250 mg at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a placebo capsule at 0 and 180 minutes
11167558|NCT01980524|FG001|Participant Flow|Placebo|Participants received a placebo capsule at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a acipimox 250 mg at 0 and 180 minutes
11167559|NCT01980524|OG000|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
11167560|NCT01980524|OG001|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)~placebo"
11167561|NCT01980524|EG000|Reported Event|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
11167562|NCT01980524|EG001|Reported Event|Acipimox-|"1 Tablet at 0 and 180 minutes (one day)~acipimox"
11167563|NCT01980589|BG000|Baseline|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167564|NCT01980589|BG001|Baseline|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167565|NCT01980589|BG002|Baseline|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167566|NCT01980589|BG003|Baseline|Total|Total of all reporting groups
11167567|NCT01980589|FG000|Participant Flow|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167568|NCT01980589|FG001|Participant Flow|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11353041|NCT03911752|OG001|Outcome|Partners of People With Acquired Brain Injury|Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
11230960|NCT02410161|OG000|Outcome|Young Group 4 Week ALA Treatment|"Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks~alpha-linolenic acid-rich supplement: each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined)."
11230961|NCT02410161|OG001|Outcome|Old Group 4 Week ALA Treatment|"Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks~alpha-linolenic acid-rich supplement: each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined)."
11230962|NCT02410161|EG000|Reported Event|Young Group 4 Week ALA Treatment|"Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks~alpha-linolenic acid-rich supplement: each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined)."
11230963|NCT02410161|EG001|Reported Event|Old Group 4 Week ALA Treatment|"Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks~alpha-linolenic acid-rich supplement: each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined)."
11230964|NCT02410200|BG000|Baseline|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
11230965|NCT02410200|FG000|Participant Flow|BG00012|BG00012 taken orally at a dose of 120 mg twice daily (BID) for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
11230966|NCT02410200|OG000|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
11230967|NCT02410200|EG000|Reported Event|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
11230968|NCT02410213|BG000|Baseline|Ferric Carboxymaltose (FCM)|"FCM at 7.5 mg/kg or 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
11230969|NCT02410213|FG000|Participant Flow|Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg|"FCM at 7.5 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
11230970|NCT02410213|FG001|Participant Flow|Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg|FCM at 15mg/kg to a maximum single dose of 750mg iron, whichever is smaller
11230971|NCT02410213|OG000|Outcome|Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg|"FCM at 7.5 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
11230972|NCT02410213|OG001|Outcome|Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg|FCM at 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller
11230973|NCT02410213|EG000|Reported Event|Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg|"FCM at 7.5 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
11230974|NCT02410213|EG001|Reported Event|Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg|"FCM at 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
11230975|NCT02410252|BG000|Baseline|Temperature Monitoring Group|This was a single arm usability and feasibility study. All participants were enrolled into the same group where they used the study device to monitor their temperature for two weeks.
11230976|NCT02410252|FG000|Participant Flow|Temperature Monitoring Group|This was a single arm usability and feasibility study. All participants were enrolled into the same group and used the temperature monitoring device for 2 weeks.
11230977|NCT02410252|OG000|Outcome|Temperature Monitoring Group|This was a single arm usability and feasibility study. All participants were enrolled into the same group and monitored their body temperature using the study device for 2 weeks.
11230978|NCT02410252|OG000|Outcome|Temperature Monitoring Group|This was a single arm usability and feasibility study. All participants were enrolled into the same group and used the study device to monitor body temperature for 2 weeks.
11230979|NCT02410252|OG000|Outcome|Temperature Monitoring Group|This was a single arm usability and feasibility study. All participants were enrolled into the same group and asked to monitor their body temperature for 2 weeks using the study device.
11230980|NCT02410252|EG000|Reported Event|Temperature Monitoring Group|"Single group subjects that will use the iThermonitor device to collect temperature information for two weeks.~iThermonitor: The device is a continuous temperature monitoring tool for home monitoring of temperature"
11230981|NCT02410278|BG000|Baseline|MITT- Placebo|Participants who reached the predefined threshold in scores on the GSRS during the Run-in Period entered the Study Treatment Period. Participants continued to receive 240 mg DMF twice daily and also received a montelukast-matching placebo tablet once daily by mouth for 8 weeks. Participants received only 240 mg DMF twice daily for 2 weeks after discontinuing treatment with placebo, then were followed for 2 additional weeks before a final phone interview. One participant randomized to placebo was excluded from the MITT.
11335560|NCT03552549|BG001|Baseline|INTRON A|Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery
11230982|NCT02410278|BG001|Baseline|MITT-Montelukast|Participants who reached the predefined threshold in scores on the GSRS during the Run-in Period entered the Study Treatment Period. Participants continued to receive 240 mg DMF twice daily and also received 10 mg of montelukast once daily by mouth for 8 weeks. Participants received only 240 mg DMF twice daily for 2 weeks after discontinuing treatment with montelukast, then were followed for 2 additional weeks before a final phone interview.
11230983|NCT02410278|BG002|Baseline|Total|Total of all reporting groups
11230984|NCT02410278|FG000|Participant Flow|Dimethyl Fumarate (DMF)- Run-in Period|Participants received 120 milligrams (mg) of DMF twice daily by mouth for 7 days and 240 mg twice daily (as described in the USPI) for up to 28 days. Participants who reached the predefined threshold in scores on the GSRS continued to the Study Treatment Period; all other participants were discontinued from the study.
11230985|NCT02410278|FG001|Participant Flow|Placebo- Study Treatment|Participants who reached the predefined threshold in scores on the GSRS during the Run-in Period entered the Study Treatment Period. Participants continued to receive 240 mg DMF twice daily and also received a montelukast-matching placebo tablet once daily by mouth for 8 weeks. Participants received only 240 mg DMF twice daily for 2 weeks after discontinuing treatment with placebo, then were followed for 2 additional weeks before a final phone interview.
11230986|NCT02410278|FG002|Participant Flow|Montelukast- Study Treatment|Participants who reached the predefined threshold in scores on the GSRS during the Run-in Period entered the Study Treatment Period. Participants continued to receive 240 mg DMF twice daily and also received 10 mg of montelukast once daily by mouth for 8 weeks. Participants received only 240 mg DMF twice daily for 2 weeks after discontinuing treatment with montelukast, then were followed for 2 additional weeks before a final phone interview.
11230987|NCT02410278|OG000|Outcome|MITT-Placebo|Participants who reached the predefined threshold in scores on the GSRS during the Run-in Period entered the Study Treatment Period. Participants continued to receive 240 mg DMF twice daily and also received a montelukast-matching placebo tablet once daily by mouth for 8 weeks. Participants received only 240 mg DMF twice daily for 2 weeks after discontinuing treatment with placebo, then were followed for 2 additional weeks before a final phone interview. One participant randomized to placebo was excluded from the MITT.
11230988|NCT02410278|OG001|Outcome|MITT-Montelukast|Participants who reached the predefined threshold in scores on the GSRS during the Run-in Period entered the Study Treatment Period. Participants continued to receive 240 mg DMF twice daily and also received 10 mg of montelukast once daily by mouth for 8 weeks. Participants received only 240 mg DMF twice daily for 2 weeks after discontinuing treatment with montelukast, then were followed for 2 additional weeks before a final phone interview.
11230989|NCT02410278|EG000|Reported Event|DMF Safety Population|Participants who received at least 1 dose of DMF.
11230990|NCT02410278|EG001|Reported Event|Primary Safety Population-Placebo|Participants who received at least 1 dose of placebo during the Study Treatment Period.
11230991|NCT02410278|EG002|Reported Event|Primary Safety Population-Montelukast|Participants who received at least 1 dose of montelukast during the Study Treatment Period.
11230992|NCT02410291|BG000|Baseline|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
11230993|NCT02410291|BG001|Baseline|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients' satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists' satisfaction with patients' rectal preparation.
11230994|NCT02410291|BG002|Baseline|Total|Total of all reporting groups
11230995|NCT02410291|FG000|Participant Flow|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
11230996|NCT02410291|FG001|Participant Flow|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients' satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists' satisfaction with patients' rectal preparation.
11335561|NCT03552549|BG002|Baseline|Total|Total of all reporting groups
11335562|NCT03552549|FG000|Participant Flow|PEG-Intron|Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery
11230997|NCT02410291|OG000|Outcome|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
11230998|NCT02410291|OG001|Outcome|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients' satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists' satisfaction with patients' rectal preparation.
11230999|NCT02410291|EG000|Reported Event|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
11231000|NCT02410291|EG001|Reported Event|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients' satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists' satisfaction with patients' rectal preparation.
11231001|NCT02410382|BG000|Baseline|Arm 1 Placebo|"Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days~Placebo: oral placebo"
11231002|NCT02410382|BG001|Baseline|Arm 2 Dexamethesone|"Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days~Dexamethasone: oral dexamethasone 4 mg bid for 14 days"
11231003|NCT02410382|BG002|Baseline|Total|Total of all reporting groups
11231004|NCT02410382|FG000|Participant Flow|Arm 1 Placebo|"Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days~Placebo: oral placebo"
11231005|NCT02410382|FG001|Participant Flow|Arm 2 Dexamethesone|"Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days~Dexamethasone: oral dexamethasone 4 mg bid for 14 days"
11231006|NCT02410382|OG000|Outcome|Arm 1 Placebo|"Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days~Placebo: oral placebo"
11231007|NCT02410382|OG001|Outcome|Arm 2 Dexamethesone|"Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days~Dexamethasone: oral dexamethasone 4 mg bid for 14 days"
11231008|NCT02410382|EG000|Reported Event|Arm 1 Placebo|"Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days~Placebo: oral placebo"
11231009|NCT02410382|EG001|Reported Event|Arm 2 Dexamethesone|"Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days~Dexamethasone: oral dexamethasone 4 mg bid for 14 days"
11231010|NCT02410629|BG000|Baseline|Music Glove First - Conventional Second|"Music Glove is a glove with sensors attached to the tips of all 5 fingers. The glove is connected to a software musical program like guitar hero. Participants will follow the rhythm or musical notes of the songs and move their fingers accordingly. Participants are reinforced with biofeedback that includes visual and auditory cues when the correct sequences are achieved.~Music Glove: Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimal of 3 hours per week."
11231011|NCT02410629|BG001|Baseline|Conventional Hand Exercise Program First - Music Glove Second|"Conventional Hand Exercise Program includes range of motion exercises, strengthening exercises, coordinating exercises of the hand and fingers. This exercise program is designed by an occupational therapist and is a general exercise program that a stroke patient will receive when he/she is being discharged from the hospital.~Conventional Hand Exercise Program: Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimal of 3 hours per week."
11231012|NCT02410629|BG002|Baseline|Total|Total of all reporting groups
11231013|NCT02410629|FG000|Participant Flow|Music Glove First Then Conventional Hand Exercise Program|"Music Glove is a glove with sensors attached to the tips of all 5 fingers. The glove is connected to a software musical program like guitar hero. Participants will follow the rhythm or musical notes of the songs and move their fingers accordingly. Participants are reinforced with biofeedback that includes visual and auditory cues when the correct sequences are achieved.~Music Glove: Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimal of 3 hours per week."
11231014|NCT02410629|FG001|Participant Flow|Conventional Hand Exercise Program First Then Music Glove|"Conventional Hand Exercise Program includes range of motion exercises, strengthening exercises, coordinating exercises of the hand and fingers. This exercise program is designed by an occupational therapist and is a general exercise program that a stroke patient will receive when he/she is being discharged from the hospital.~Conventional Hand Exercise Program: Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimal of 3 hours per week."
11231015|NCT02410629|OG000|Outcome|Music Glove First Then Conventional Hand Exercise Program|"Music Glove is a glove with sensors attached to the tips of all 5 fingers. The glove is connected to a software musical program like guitar hero. Participants will follow the rhythm or musical notes of the songs and move their fingers accordingly. Participants are reinforced with biofeedback that includes visual and auditory cues when the correct sequences are achieved.~Music Glove: Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimal of 3 hours per week."
11231016|NCT02410629|OG001|Outcome|Conventional Hand Exercise Program First Then Music Glove|"Conventional Hand Exercise Program includes range of motion exercises, strengthening exercises, coordinating exercises of the hand and fingers. This exercise program is designed by an occupational therapist and is a general exercise program that a stroke patient will receive when he/she is being discharged from the hospital.~Conventional Hand Exercise Program: Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimal of 3 hours per week."
11231017|NCT02410629|EG000|Reported Event|Music Glove First - Conventional Second|"Music Glove is a glove with sensors attached to the tips of all 5 fingers. The glove is connected to a software musical program like guitar hero. Participants will follow the rhythm or musical notes of the songs and move their fingers accordingly. Participants are reinforced with biofeedback that includes visual and auditory cues when the correct sequences are achieved.~Music Glove: Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimal of 3 hours per week."
11231018|NCT02410629|EG001|Reported Event|Conventional Hand Exercise Program First - Music Glove Second|"Conventional Hand Exercise Program includes range of motion exercises, strengthening exercises, coordinating exercises of the hand and fingers. This exercise program is designed by an occupational therapist and is a general exercise program that a stroke patient will receive when he/she is being discharged from the hospital.~Conventional Hand Exercise Program: Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimal of 3 hours per week."
11231019|NCT02410707|BG000|Baseline|Nitrous Oxide Arm|"Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.~Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.~Propofol: The loading dose of propofol will be administered immediately after nitrous oxide use"
11231020|NCT02410707|FG000|Participant Flow|Nitrous Oxide Arm|"Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.~Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.~Propofol: The loading dose of propofol will be administered immediately after nitrous oxide use"
11231021|NCT02410707|OG000|Outcome|Nitrous Oxide Arm|Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
11231022|NCT02410707|OG000|Outcome|Nitrous Oxide Arm|"Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.~Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing."
11231023|NCT02410707|OG000|Outcome|Nitrous Oxide Arm|Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
10887911|NCT00503776|OG000|Outcome|Arm IA|"Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
11231024|NCT02410707|EG000|Reported Event|Nitrous Oxide Arm|"Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.~Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing."
11231025|NCT02410772|BG000|Baseline|Regimen 1 (2HRZE/4HR)|"Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~control: standard six-month treatment"
11231026|NCT02410772|BG001|Baseline|Regimen 2 (2HPZ/2HP)|"Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~rifapentine: Regimen 2: Rifapentine is substituted for rifampin as the basis of 4-month treatment"
11231027|NCT02410772|BG002|Baseline|Regimen 3 (2HPMZ/2HPM)|"Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; moxifloxacin, 400 mg~rifapentine and moxifloxacin: Regimen 3: In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol."
11231028|NCT02410772|BG003|Baseline|Total|Total of all reporting groups
11231029|NCT02410772|FG000|Participant Flow|Regimen 1 (2HRZE/4HR)|"Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~control: standard six-month treatment"
11231030|NCT02410772|FG001|Participant Flow|Regimen 2 (2HPZ/2HP)|"Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~rifapentine: Regimen 2: Rifapentine is substituted for rifampin as the basis of 4-month treatment"
11231031|NCT02410772|FG002|Participant Flow|Regimen 3 (2HPMZ/2HPM)|"Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; moxifloxacin, 400 mg~rifapentine and moxifloxacin: Regimen 3: In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol."
11335563|NCT03552549|FG001|Participant Flow|INTRON A|Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery
11231032|NCT02410772|OG000|Outcome|Regimen 1 (2HRZE/4HR)|"Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~control: standard six-month treatment"
11231033|NCT02410772|OG001|Outcome|Regimen 2 (2HPZ/2HP)|"Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~rifapentine: Regimen 2: Rifapentine is substituted for rifampin as the basis of 4-month treatment"
11231034|NCT02410772|OG002|Outcome|Regimen 3 (2HPMZ/2HPM)|"Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; moxifloxacin, 400 mg~rifapentine and moxifloxacin: Regimen 3: In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol."
11231035|NCT02410772|EG000|Reported Event|Regimen 1 (2HRZE/4HR)|"Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~control: standard six-month treatment"
11231036|NCT02410772|EG001|Reported Event|Regimen 2 (2HPZ/2HP)|"Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~rifapentine: Regimen 2: Rifapentine is substituted for rifampin as the basis of 4-month treatment"
11231037|NCT02410772|EG002|Reported Event|Regimen 3 (2HPMZ/2HPM)|"Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin~All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg~study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; moxifloxacin, 400 mg~rifapentine and moxifloxacin: Regimen 3: In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol."
11231038|NCT02410798|BG000|Baseline|TransLoc Electrode|"Electrode placement~TransLoc electrode: Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery."
11231039|NCT02410798|FG000|Participant Flow|TransLoc Electrode|"Electrode placement~TransLoc electrode: Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery."
11231040|NCT02410798|OG000|Outcome|Treatment|Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
11231041|NCT02410798|OG000|Outcome|Treatment|Patients will have 2 TransLoc electrodes placed in each hemi-diaphragm (total 4 electrodes) during their primary surgery.
11231042|NCT02410798|EG000|Reported Event|Treatment|Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
11231043|NCT02410811|BG000|Baseline|Stratum A (6-13.99 Years)|"Age 6 to 13.99 years.~Sickle cell anemia or sickle-β0-thalassemia."
11231044|NCT02410811|BG001|Baseline|Stratum B (14-20.99 Years)|"Age 14 to 20.99 years.~Sickle cell anemia or sickle-β0-thalassemia.~Detectible and quantifiable tricuspid regurgitant jet velocity (TRJV)."
11231045|NCT02410811|BG002|Baseline|Stratum C (≥21 Years)|"Age ≥21 years.~Sickle cell anemia or sickle-β0-thalassemia.~Detectible and quantifiable tricuspid regurgitant jet velocity (TRJV)."
11353042|NCT03911752|OG002|Outcome|Relatives of People With Acquired Brain Injury|Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
11353043|NCT03911752|OG001|Outcome|Partners of People With Acquired Brain Injury|Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy
11353044|NCT03911752|OG002|Outcome|Relatives of People With Acquired Brain Injury|Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy
11353045|NCT03911752|EG000|Reported Event|People With Acquired Brain Injury|People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).
11353046|NCT03911752|EG001|Reported Event|Partners of People With Acquired Brain Injury|Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
11353047|NCT03911752|EG002|Reported Event|Relatives of People With Acquired Brain Injury|Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
11353048|NCT03902613|BG000|Baseline|Lurasidone|"Open-label treatment with lurasidone within the dose range of 20-60 mg daily~Lurasidone: Participant will have an open label trial of lurasidone for eight weeks."
11353049|NCT03902613|FG000|Participant Flow|Lurasidone|"Open-label treatment with lurasidone within the dose range of 20-60 mg daily~Lurasidone: Participant will have an open label trial of lurasidone for eight weeks."
11353050|NCT03902613|OG000|Outcome|Lurasidone|"Open-label treatment with lurasidone within the dose range of 20-60 mg daily~Lurasidone: Participant will have an open label trial of lurasidone for eight weeks."
11353051|NCT03902613|EG000|Reported Event|Lurasidone|"Open-label treatment with lurasidone within the dose range of 20-60 mg daily~Lurasidone: Participant will have an open label trial of lurasidone for eight weeks."
11353052|NCT03902574|BG000|Baseline|Sequence 1: ODT Without Water/Conventional/ODT With Water|Subjects randomized to Sequence 1 received a brexpiprazole ODT 2 mg without water on Day 1 in Period 1 (Days 1 to 20), then a brexpiprazole conventional tablet 2 mg on Day 21 in Period 2 (Days 21 to 40), then a brexpiprazole ODT 2 mg with water on Day 41 in Period 3 (Days 41 to 60).
11353053|NCT03902574|BG001|Baseline|Sequence 2: ODT With Water/ODT Without Water/Conventional|Subjects randomized to Sequence 2 received a brexpiprazole ODT 2 mg with water on Day 1 in Period 1 (Days 1 to 20), then a brexpiprazole ODT 2 mg without water on Day 21 in Period 2 (Days 21 to 40), then a brexpiprazole conventional tablet 2 mg on Day 41 in Period 3 (Days 41 to 60).
11353054|NCT03902574|BG002|Baseline|Sequence 3: Conventional/ODT With Water/ODT Without Water|Subjects randomized to Sequence 3 received a brexpiprazole conventional tablet 2 mg on Day 1 in Period 1 (Days 1 to 20), then a brexpiprazole ODT 2 mg with water on Day 21 in Period 2 (Days 21 to 40), then a brexpiprazole ODT 2 mg without water on Day 41 in Period 3 (Days 41 to 60).
11353055|NCT03902574|BG003|Baseline|Total|Total of all reporting groups
11353056|NCT03902574|FG000|Participant Flow|Sequence 1: ODT Without Water/Conventional/ODT With Water|Subjects randomized to Sequence 1 received a brexpiprazole ODT 2 mg without water on Day 1 in Period 1 (Days 1 to 20), then a brexpiprazole conventional tablet 2 mg on Day 21 in Period 2 (Days 21 to 40), then a brexpiprazole ODT 2 mg with water on Day 41 in Period 3 (Days 41 to 60).
11353057|NCT03902574|FG001|Participant Flow|Sequence 2: ODT With Water/ODT Without Water/Conventional|Subjects randomized to Sequence 2 received a brexpiprazole ODT 2 mg with water on Day 1 in Period 1 (Days 1 to 20), then a brexpiprazole ODT 2 mg without water on Day 21 in Period 2 (Days 21 to 40), then a brexpiprazole conventional tablet 2 mg on Day 41 in Period 3 (Days 41 to 60).
10887912|NCT00503776|OG001|Outcome|Arm IB|"Patients undergo SNT and low weight resistance training (LWRT).~exercise intervention: Patients undergo low weight resistance training.~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
11353058|NCT03902574|FG002|Participant Flow|Sequence 3: Conventional/ODT With Water/ODT Without Water|Subjects randomized to Sequence 3 received a brexpiprazole conventional tablet 2 mg on Day 1 in Period 1 (Days 1 to 20), then a brexpiprazole ODT 2 mg with water on Day 21 in Period 2 (Days 21 to 40), then a brexpiprazole ODT 2 mg without water on Day 41 in Period 3 (Days 41 to 60).
11353059|NCT03902574|OG000|Outcome|Conventional Tablet|Brexpiprazole conventional tablet 2 mg was administered with water.
11353060|NCT03902574|OG001|Outcome|ODT Without Water|Brexpiprazole ODT 2 mg was administered without water.
11353061|NCT03902574|OG002|Outcome|ODT With Water|Brexpiprazole ODT 2 mg was administered with water.
11353062|NCT03902574|EG000|Reported Event|Conventional Tablet|Brexpiprazole conventional tablet 2 mg was administered with water.
11353063|NCT03902574|EG001|Reported Event|ODT Without Water|Brexpiprazole ODT 2 mg was administered without water.
11353064|NCT03902574|EG002|Reported Event|ODT With Water|Brexpiprazole ODT 2 mg was administered with water.
11353065|NCT03914950|BG000|Baseline|PET/CT Results With TOF/Without TOF|Participants received TOF-18F-FDG PET/CT 30 and 90 min p.i. and diagnostic CT of the abdomen or upper abdomen (in case of already performed diagnostic CT of the abdomen < 2 weeks ago) with contrast medium in case of normal creatinine, GFR, and TSH levels. In the case of elevated creatinine and decreased GFR and TSH levels a diagnostic CT without contrast medium was performed. After PET/CT examination participants received biopsy or FNA or operation of the pancreas.
11353066|NCT03914950|FG000|Participant Flow|PET/CT Results With TOF/Without TOF|Participants received TOF-18F-FDG PET/CT 30 and 90min p.i. and diagnostic CT of the abdomen or upper abdomen (in case of already performed diagnostic CT of the abdomen < 2 weeks ago) with contrast medium in the case of normal creatinine, GFR, and TSH levels (101 participants). In the case of elevated creatinine or decreased GFR or TSH levels a diagnostic CT without contrast medium was performed (19 participants). After PET/CT examination the participants received a biopsy or FNA (fine-needle aspiration) or operation of the pancreas.
11353067|NCT03914950|OG000|Outcome|SUVmax TOF 30min p.i.|SUVmax values of the pancreatic lesions with TOF 30min p.i.
11353068|NCT03914950|OG001|Outcome|SUVmax Without TOF 30min p.i.|SUVmax values of the pancreatic lesions without TOF 30min p.i.
11353069|NCT03914950|OG002|Outcome|SUVmax TOF 90min p.i.|SUVmax values of the pancreatic lesions with TOF 90min p.i.
11353070|NCT03914950|OG003|Outcome|SUVmax Without TOF 90min p.i.|SUVmax values of the pancreatic lesions without TOF 90min p.i.
11353071|NCT03914950|OG000|Outcome|Participants With Increased Tracer Uptake With TOF|The number of participants with increased tracer uptake with TOF in early or delayed or both images.
10887913|NCT00503776|OG002|Outcome|Arm IIA|"Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.~amifostine trihydrate: Given subcutaneously~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
11167569|NCT01980589|FG002|Participant Flow|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167570|NCT01980589|OG000|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167571|NCT01980589|OG001|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167572|NCT01980589|OG002|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167573|NCT01980589|EG000|Reported Event|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167574|NCT01980589|EG001|Reported Event|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167575|NCT01980589|EG002|Reported Event|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11167576|NCT01980628|BG000|Baseline|Ibrutinib|Subjects receive a daily dose of 560 mg of ibrutinib capsules
11167577|NCT01980628|FG000|Participant Flow|Ibrutinib|Subjects receive daily dose of 560 mg of ibrutinib capsules.
11167578|NCT01980628|OG000|Outcome|Single Arm, Intent to Treat Population|
11167579|NCT01980628|OG000|Outcome|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
11167580|NCT01980628|EG000|Reported Event|Ibrutinib|ibrutinib capsules: 560 mg once daily
11167581|NCT01980654|BG000|Baseline|Main Study Arm 1|"Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.~Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally.~rituximab: All subjects will receive rituximab 375 mg/m2 intravenously"
11167582|NCT01980654|BG001|Baseline|Exploratory Study Arm 2|"Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.~Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally.~rituximab: All subjects will receive rituximab 375 mg/m2 intravenously"
11167583|NCT01980654|BG002|Baseline|Total|Total of all reporting groups
11167584|NCT01980654|FG000|Participant Flow|Main Study Arm 1|"Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.~Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally.~rituximab: All subjects will receive rituximab 375 mg/m2 intravenously"
11167585|NCT01980654|FG001|Participant Flow|Exploratory Study Arm 2|"Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.~Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally.~rituximab: All subjects will receive rituximab 375 mg/m2 intravenously"
11167586|NCT01980654|OG000|Outcome|Main Study Arm 1|"Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.~Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally.~rituximab: All subjects will receive rituximab 375 mg/m2 intravenously"
11167587|NCT01980654|OG001|Outcome|Exploratory Study Arm 2|"Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.~Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally.~rituximab: All subjects will receive rituximab 375 mg/m2 intravenously"
11231046|NCT02410811|BG003|Baseline|Stratum D (Early Treatment)|"Age ≥6 years.~Sickle cell anemia or sickle-β0-thalassemia.~Current use of disease-modifying therapy [hydroxyurea, chronic transfusions, or both (given concurrently, sequentially, or both)] that was initiated at <3 years of age, and for which there has been no interruption of therapy for >6 consecutive months since the initiation of disease-modifying therapy."
11231047|NCT02410811|BG004|Baseline|Total|Total of all reporting groups
11231048|NCT02410811|FG000|Participant Flow|Stratum A (6-13.99 Years)|"Age 6 to 13.99 years.~Sickle cell anemia or sickle-β0-thalassemia."
11231049|NCT02410811|FG001|Participant Flow|Stratum B (14-20.99 Years)|"Age 14 to 20.99 years.~Sickle cell anemia or sickle-β0-thalassemia.~Detectible and quantifiable tricuspid regurgitant jet velocity (TRJV)."
11231050|NCT02410811|FG002|Participant Flow|Stratum C (≥21 Years)|"Age ≥21 years.~Sickle cell anemia or sickle-β0-thalassemia.~Detectible and quantifiable tricuspid regurgitant jet velocity (TRJV)."
11231051|NCT02410811|FG003|Participant Flow|Stratum D (Early Treatment)|"Age ≥6 years.~Sickle cell anemia or sickle-β0-thalassemia.~Current use of disease-modifying therapy [hydroxyurea, chronic transfusions, or both (given concurrently, sequentially, or both)] that was initiated at <3 years of age, and for which there has been no interruption of therapy for >6 consecutive months since the initiation of disease-modifying therapy."
11231052|NCT02410811|OG000|Outcome|Stratum A (6-13.99 Years)|"Age 6 to 13.99 years.~Sickle cell anemia or sickle-β0-thalassemia."
11231053|NCT02410811|OG001|Outcome|Stratum B (14-20.99 Years)|"Age 14 to 20.99 years.~Sickle cell anemia or sickle-β0-thalassemia.~Detectible and quantifiable tricuspid regurgitant jet velocity (TRJV)."
11231054|NCT02410811|OG002|Outcome|Stratum C (≥21 Years)|"Age ≥21 years.~Sickle cell anemia or sickle-β0-thalassemia.~Detectible and quantifiable tricuspid regurgitant jet velocity (TRJV)."
11231055|NCT02410811|OG003|Outcome|Stratum D (Early Treatment)|"Age ≥6 years.~Sickle cell anemia or sickle-β0-thalassemia.~Current use of disease-modifying therapy [hydroxyurea, chronic transfusions, or both (given concurrently, sequentially, or both)] that was initiated at <3 years of age, and for which there has been no interruption of therapy for >6 consecutive months since the initiation of disease-modifying therapy."
11231056|NCT02410811|EG000|Reported Event|Stratum A (6-13.99 Years)|"Age 6 to 13.99 years.~Sickle cell anemia or sickle-β0-thalassemia."
11231057|NCT02410811|EG001|Reported Event|Stratum B (14-20.99 Years)|"Age 14 to 20.99 years.~Sickle cell anemia or sickle-β0-thalassemia.~Detectible and quantifiable tricuspid regurgitant jet velocity (TRJV)."
11231058|NCT02410811|EG002|Reported Event|Stratum C (≥21 Years)|"Age ≥21 years.~Sickle cell anemia or sickle-β0-thalassemia.~Detectible and quantifiable tricuspid regurgitant jet velocity (TRJV)."
11231059|NCT02410811|EG003|Reported Event|Stratum D (Early Treatment)|"Age ≥6 years.~Sickle cell anemia or sickle-β0-thalassemia.~Current use of disease-modifying therapy [hydroxyurea, chronic transfusions, or both (given concurrently, sequentially, or both)] that was initiated at <3 years of age, and for which there has been no interruption of therapy for >6 consecutive months since the initiation of disease-modifying therapy."
11231060|NCT02410824|BG000|Baseline|Overall Baseline Characteristics|Participants were randomized to wear stenfilcon A toric lens or etafilcon A toric lens bilaterally for one week, then cross over to the alternative pair.
11231061|NCT02410824|FG000|Participant Flow|Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week, then cross over to the etafilcon A toric lens.~stenfilcon A: toric contact lens~etafilcon A: toric contact lens"
11231062|NCT02410824|FG001|Participant Flow|Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week, then cross over to the stenfilcon A toric lens.~etafilcon A: toric contact lens~stenfilcon A: toric contact lens"
11231063|NCT02410824|OG000|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
11231064|NCT02410824|OG001|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
11231065|NCT02410824|OG000|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric lens contact lens"
11231066|NCT02410824|EG000|Reported Event|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
11231067|NCT02410824|EG001|Reported Event|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
11231068|NCT02410837|BG000|Baseline|NAVIGATE (Single Arm Study)|Observational NAVIGATE arm (single arm study, no comparator)
11231069|NCT02410837|FG000|Participant Flow|NAVIGATE (Single Arm Study)|Observational NAVIGATE arm (single arm study, no comparator)
11231070|NCT02410837|OG000|Outcome|NAVIGATE (Single Arm Study)|Observational NAVIGATE arm (single arm study, no comparator)
11231071|NCT02410837|EG000|Reported Event|NAVIGATE (Single Arm Study)|Observational NAVIGATE arm (single arm study, no comparator)
11231072|NCT02410967|BG000|Baseline|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program.~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
11231073|NCT02410967|BG001|Baseline|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
11231074|NCT02410967|BG002|Baseline|Total|Total of all reporting groups
11353072|NCT03914950|OG001|Outcome|Participants With Increased Tracer Uptake Without TOF|The number of participants with increased tracer uptake without TOF in early or delayed or both images.
11353073|NCT03914950|OG000|Outcome|Lesion Size in cm|The lesion size in cm was measured by the radiologist on diagnostic CT.
11353074|NCT03914950|EG000|Reported Event|PET/CT Results With TOF/ Without TOF|101 participants received diagnostic CT of the abdomen/upper abdomen with contrast medium within the PET/CT examination and 19 participants had diagnostic CT of the abdomen or upper abdomen without contrast medium due to elevated creatine or decreased GFR (glomerular filtration rate) or TSH (thyroid-stimulating hormone) levels.
11353075|NCT03911843|BG000|Baseline|CASES|"The T1D onsets were eligible subjects, of which 26/64 new onsets started an intervention program with Ω-3 (CASES). The intervention consisted in supplementation with highly purified Ω-3, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 60 mg/kg/day for 12 months. The supplementation with omega 3 started within 3th and 6th months of T1D clinical onset and lasted one year.~They had been introduced to the Mediterranean diet according to a standardized item and received 1000 IU/day of vitamin D supplementation since the beginning of T1D"
11353076|NCT03911843|BG001|Baseline|CONTROLS|The Previous T1D onsets, 38/64 subjects joined to the study as controls (CONTROLS). They received vitamin D supplementation 1000 IU/day and Mediterranean diet according to a standardized item since the onset of T1D, without omega 3; retrospectively their available data from 3th and 6th months of overt disease for the following year, were compared
11353077|NCT03911843|BG002|Baseline|Total|Total of all reporting groups
11353078|NCT03911843|FG000|Participant Flow|CASES New T1D Onsets 2017|All the New T1D Onsets 2017 received a further supplementation of ultra refined fish oil, enriched in LC-PUFA omega 3, containing standardized concentrations EPA + DHA (2:1), at 60 mg/kg/day. The supplementation with omega 3 started within 3th and 6th months after the clinical T1D onset and lasted one year.
11353079|NCT03911843|FG001|Participant Flow|CONTROLS Previous T1D Onsets|All Previous T1D Onsets (2014-2016) receiving vitamin D and Mediterranean diet without omega 3 supplementation, were continuously recruited. Retrospectively their available data from 3th and 6th months from the clinical onset to T1D, for the following year, were compared.
11353080|NCT03911843|OG000|Outcome|CASES New T1D Onsets 2017|All the New T1D Onsets 2017 received a further supplementation of ultra refined fish oil, enriched in LC-PUFA omega 3, containing standardized concentrations EPA + DHA (2:1), at 60 mg/kg/day. The supplementation with omega 3 started within 3th and 6th months after the clinical T1D onset and lasted one year.
11353081|NCT03911843|OG001|Outcome|CONTROLS Previous T1D Onsets|All Previous T1D Onsets (2014-2016) receiving vitamin D and Mediterranean diet without omega 3 supplementation, were continuously recruited. Retrospectively their available data from 3th and 6th months from the clinical onset to T1D, for the following year, were compared.
11353082|NCT03911843|EG000|Reported Event|CASES New T1D Onsets 2017|All the New T1D Onsets 2017 received Mediterranean diet, vitamin D 1000 IU/day, and a further supplementation of ultra refined fish oil, enriched in LC-PUFA omega 3, containing standardized concentrations EPA + DHA (2:1), at 60 mg/kg/day. The supplementation with omega 3 started within 3th and 6th months after the clinical T1D onset and lasted one year.
11353083|NCT03911843|EG001|Reported Event|CONTROLS Previous T1D Onsets|All Previous T1D Onsets (2014-2016) receiving vitamin D and Mediterranean diet without omega 3 supplementation, were continuously recruited. Retrospectively their available data from 3th and 6th months from the clinical onset to T1D, for the following year, were compared.
11353084|NCT03896633|BG000|Baseline|Brinzolamide 1% Ophthalmic Suspension|"ophthalmic suspension~brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension"
11353085|NCT03896633|BG001|Baseline|Azopt 1% Ophthalmic Suspension|"Ophthalmic suspension~Azopt 1%: Azopt 1%, RLD"
11353086|NCT03896633|BG002|Baseline|Total|Total of all reporting groups
11353087|NCT03896633|FG000|Participant Flow|Brinzolamide 1% Ophthalmic Suspension|"ophthalmic suspension~brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension"
11353088|NCT03896633|FG001|Participant Flow|Azopt 1% Ophthalmic Suspension|"Ophthalmic suspension~Azopt 1%: Azopt 1%, RLD"
11353089|NCT03896633|OG000|Outcome|Brinzolamide 1% Ophthalmic Suspension|"ophthalmic suspension~brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension"
11353090|NCT03896633|OG001|Outcome|Azopt 1% Ophthalmic Suspension|"Ophthalmic suspension~Azopt 1%: Azopt 1%, RLD"
11353091|NCT03896633|EG000|Reported Event|Brinzolamide 1% Ophthalmic Suspension|"ophthalmic suspension~brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension"
11353092|NCT03896633|EG001|Reported Event|Azopt 1% Ophthalmic Suspension|"Ophthalmic suspension~Azopt 1%: Azopt 1%, RLD"
11353093|NCT03894813|BG000|Baseline|Probiotics and Metronidazole|"Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)~Probiotics and Metronidazole: Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)"
11353094|NCT03894813|BG001|Baseline|Metronidazole Vaginal|"Metronidazole vaginal suppositories(1 suppositories,qd,7 days )~Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days"
11353095|NCT03894813|BG002|Baseline|Total|Total of all reporting groups
11353096|NCT03894813|FG000|Participant Flow|Probiotics and Metronidazole|"Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)~Probiotics and Metronidazole: Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)"
11353097|NCT03894813|FG001|Participant Flow|Metronidazole Vaginal|"Metronidazole vaginal suppositories(1 suppositories,qd,7 days )~Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days"
11353098|NCT03894813|OG000|Outcome|Probiotics and Metronidazole|"Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)~Probiotics and Metronidazole: Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)"
11353099|NCT03894813|OG001|Outcome|Metronidazole Vaginal|"Metronidazole vaginal suppositories(1 suppositories,qd,7 days )~Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days"
11089455|NCT01523821|BG000|Baseline|Cohort 1 (30 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089456|NCT01523821|BG001|Baseline|Cohort 2 (60 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089457|NCT01523821|BG002|Baseline|Cohort 3 (90 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089458|NCT01523821|BG003|Baseline|Total|Total of all reporting groups
11089459|NCT01523821|FG000|Participant Flow|Cohort 1 (30 mg/kg)|"AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089460|NCT01523821|FG001|Participant Flow|Cohort 2 (60 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089461|NCT01523821|FG002|Participant Flow|Cohort 3 (90 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089462|NCT01523821|OG000|Outcome|Cohort 1 (30 mg/kg)|"AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089463|NCT01523821|OG001|Outcome|Cohort 2 (60 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089464|NCT01523821|OG002|Outcome|Cohort 3 (90 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089465|NCT01523821|EG000|Reported Event|Cohort 1 (30 mg/kg)|"AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089466|NCT01523821|EG001|Reported Event|Cohort 2 (60 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089467|NCT01523821|EG002|Reported Event|Cohort 3 (90 mg/kg)|"AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.~Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]"
11089468|NCT01523834|BG000|Baseline|Panobinosat|"The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later.~Treatment: Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW), as part of a 4 week (28 days) treatment cycle. Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle."
11089469|NCT01523834|FG000|Participant Flow|Panobinosat|"The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later.~Treatment:Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW) (e.g., on Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday), as part of a 4 week (28 days) treatment cycle.~Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy).~Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modificatio"
11089470|NCT01523834|OG000|Outcome|Panobinosat|"The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later.~Treatment: Panobinostat should be taken p.o. at the dose of 40 mg/day three-times every week (QW) (e.g., on Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday), as part of a 4 week (28 days) treatment cycle~Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy).~Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modificatio"
11089471|NCT01523834|OG000|Outcome|Panobinosat|"The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later.~Treatment:~Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy).~Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modification of drug administration from 3 times every week (QW) to 3 times every other week (QOW). Levels lower than 30 mg 3 times QOW is not permitted."
11092160|NCT01537666|OG004|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
11167588|NCT01980654|EG000|Reported Event|Main Study Arm 1|"Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.~Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally.~rituximab: All subjects will receive rituximab 375 mg/m2 intravenously"
11167589|NCT01980654|EG001|Reported Event|Exploratory Study Arm 2|"Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.~Ibrutinib: All subjects will receive 560 mg of Ibrutinib orally.~rituximab: All subjects will receive rituximab 375 mg/m2 intravenously"
11167590|NCT01980706|BG000|Baseline|Placebo|"Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.~Placebo: Pill containing no pharmacologically active substance."
11167591|NCT01980706|BG001|Baseline|30 Mg Baclofen|"Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.~Baclofen: Baclofen is a GABA-B agonist"
11167592|NCT01980706|BG002|Baseline|90 mg Baclofen|"Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.~Baclofen: Baclofen is a GABA-B agonist"
11167593|NCT01980706|BG003|Baseline|Total|Total of all reporting groups
11167594|NCT01980706|FG000|Participant Flow|Placebo|"Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.~Placebo: Pill containing no pharmacologically active substance."
11167595|NCT01980706|FG001|Participant Flow|30 Mg Baclofen|"Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.~Baclofen: Baclofen is a gamma-aminobutyric acid (GABA)-B receptor agonist"
11167596|NCT01980706|FG002|Participant Flow|90 mg Baclofen|"Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.~Baclofen: Baclofen is a GABA-B agonist"
11167597|NCT01980706|OG000|Outcome|Placebo|"Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.~Placebo: Pill containing no pharmacologically active substance."
11167598|NCT01980706|OG001|Outcome|30 Mg Baclofen|"Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.~Baclofen: Baclofen is a GABA-B agonist"
11167599|NCT01980706|OG002|Outcome|90 mg Baclofen|"Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.~Baclofen: Baclofen is a GABA-B agonist"
11167600|NCT01980706|EG000|Reported Event|Placebo|"Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.~Placebo: Pill containing no pharmacologically active substance."
11167601|NCT01980706|EG001|Reported Event|30 Mg Baclofen|"Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.~Baclofen: Baclofen is a GABA-B agonist"
11167602|NCT01980706|EG002|Reported Event|90 mg Baclofen|"Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.~Baclofen: Baclofen is a GABA-B agonist"
11167603|NCT01980771|BG000|Baseline|BTWB Intervention|"Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention.~BTWB intervention: Men work in groups to complete a intervention that takes approximately two hours to complete."
11167604|NCT01980771|BG001|Baseline|Cancer Prevention and Screening|"Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control.~Cancer prevention and screening: Men are provided health education about cancer screening and prevention"
11167605|NCT01980771|BG002|Baseline|Total|Total of all reporting groups
11167606|NCT01980771|FG000|Participant Flow|BTWB Intervention|"Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention.~BTWB intervention: Men work in groups to complete a intervention that takes approximately two hours to complete."
11167607|NCT01980771|FG001|Participant Flow|Cancer Prevention and Screening|"Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control.~Cancer prevention and screening: Men are provided health education about cancer screening and prevention"
11167608|NCT01980771|OG000|Outcome|BTWB Intervention|Men work in groups on a single session intervention.
11167609|NCT01980771|OG001|Outcome|Cancer Prevention and Screening|Men are provided with health education about prostate cancer screening and prevention in a single-session group format.
11167610|NCT01980771|EG000|Reported Event|BTWB Intervention|Men work in groups on a single session intervention.
11167611|NCT01980771|EG001|Reported Event|Cancer Prevention and Screening|Men are provided with health education about prostate cancer screening and prevention in a single-session group format.
11167612|NCT01980888|BG000|Baseline|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
11167613|NCT01980888|BG001|Baseline|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
11167614|NCT01980888|BG002|Baseline|Total|Total of all reporting groups
11335564|NCT03552549|OG000|Outcome|PEG-Intron|Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery
11231075|NCT02410967|FG000|Participant Flow|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program.~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
11231076|NCT02410967|FG001|Participant Flow|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
11231077|NCT02410967|OG000|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program.~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
11231078|NCT02410967|OG001|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
11231079|NCT02410967|EG000|Reported Event|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program.~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
11231080|NCT02410967|EG001|Reported Event|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
11231081|NCT02411084|BG000|Baseline|BEGEDINA® (Begelomab)|"Subjects have received BEGEDINA 2.7 mg/m2/day IV for 5 consecutive days (Study Days 1, 2, 3, 4, 5) and then on Study Days 10, 14, 17, 21, 24 and 28, for a total of 11 doses. A window (+/- 1 day) was permitted for doses from Day 10 to Day 28, however, all efforts have been made to plan these doses with at least 48 hours between doses.~The total volume of BEGEDINA to be administered was diluted in 100 mL of sodium chloride 9 mg/mL (0.9%) solution for injection prior to administration. The infusion lasted for 60 minutes.~Begelomab: BEGEDINA® (Begelomab) is a murine immunoglobulin G (IgG) 2b monoclonal antibody against CD26 (dipeptidyl peptidase-4; DPP4) and is produced by biotechnological means."
11231082|NCT02411084|BG001|Baseline|Conventional Second-line Treatment|"Subjects in the conventional treatment arm have received a second line treatment, which were chosen by each center, based on the clinical conditions of the individual subject and according to the standard practice at the study center. Currently no treatments for this life-threatening disease have been approved in either the USA or Europe. The recommendations of the American Society for Blood and Marrow Transplantation (ASBMT) confirm that no treatment for acute steroid-refractory GvHD can be considered gold standard in terms of TRM or survival as results remain unsatisfactory and this approach has been agreed by the FDA and the EMA.~Treatments were generally biological products and could include anti-thymocyte globulin, monoclonal antibodies, such as anti-CD147, basiliximab, daclizumab and alemtuzumab; mycophenolate mofetil; anti-TNF-alpha; pentostatin; dinileukin diftitox; N-acetyl-cysteine; sirolimus; and visulizumab."
11231083|NCT02411084|BG002|Baseline|Total|Total of all reporting groups
11231084|NCT02411084|FG000|Participant Flow|BEGEDINA® (Begelomab)|18 subjects from a total of 37 screened subjects were enrolled on Begedina arm. All subjects signed the informed consent and met all eligibility criteria.
11231085|NCT02411084|FG001|Participant Flow|Conventional Second-line Treatment|18 subjects from a total of 37 subjects were screened on Conventional Treatment arm. All subjects signed the informed consent and met all eligibility criteria.
11231086|NCT02411084|OG000|Outcome|BEGEDINA® (Begelomab)|Begelomab: BEGEDINA® (Begelomab) is a murine immunoglobulin G (IgG) 2b monoclonal antibody against CD26 (dipeptidyl peptidase-4; DPP4) and is produced by biotechnological means.
11231087|NCT02411084|OG001|Outcome|Conventional Second-line Treatment|"Conventional Second-line Treatment: There are no approved second-line treatments for aGvHD and due to the life-threatening nature of the disease it was agreed with the FDA and EMA that BEGEDINA® would be compared with best conventional second-line treatments which will be chosen by each center, based on the clinical conditions of the individual sub"
11231088|NCT02411084|EG000|Reported Event|BEGEDINA® (Begelomab)|The most frequent adverse events recorded after administration of BEGEDINA® were platelet count decreased (19.4% cases), anemia (16.7% cases), leukocytes count decreased (11.1% cases). Cytomegalovirus infection was found in 16.7% cases and peripheral edema in 13.9% cases.There were recorded 25 serious adverse events. At the end of the study rate of serious adverse events which determined early discontinuation in BEGEDINA® group was 22.2 % ( 4 subjects). At the end of the study (approx. day 180), death occurred in 36.1 % (13 subjects) in BEGEDINA® group.
11092161|NCT01537666|OG005|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
11092162|NCT01537666|OG000|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
11335565|NCT03552549|OG001|Outcome|INTRON A|Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery
11092163|NCT01537666|OG001|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
11092164|NCT01537666|OG002|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
11092165|NCT01537666|OG003|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
11092166|NCT01537666|OG000|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
11353100|NCT03894813|EG000|Reported Event|Probiotics and Metronidazole|"Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)~Probiotics and Metronidazole: Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)"
11353101|NCT03894813|EG001|Reported Event|Metronidazole Vaginal|"Metronidazole vaginal suppositories(1 suppositories,qd,7 days )~Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days"
11353102|NCT03911960|BG000|Baseline|Acceptance and Commitment Therapy|"2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch.~Acceptance and Commitment Therapy: 2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch"
11353103|NCT03911960|BG001|Baseline|Enhanced Usual Care|"2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch~Enhanced Usual Care: 2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline."
11353104|NCT03911960|BG002|Baseline|Total|Total of all reporting groups
11353105|NCT03911960|FG000|Participant Flow|Acceptance and Commitment Therapy|"2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch.~Acceptance and Commitment Therapy: 2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch"
11353106|NCT03911960|FG001|Participant Flow|Enhanced Usual Care|"2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch~Enhanced Usual Care: 2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline."
11353107|NCT03911960|OG000|Outcome|All Participants|This outcome assesses interest in the trial prior to randomization.
11353108|NCT03911960|OG000|Outcome|Acceptance and Commitment Therapy|"2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch.~Acceptance and Commitment Therapy: 2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch"
11353109|NCT03911960|OG001|Outcome|Enhanced Usual Care|"2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch~Enhanced Usual Care: 2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline."
11353110|NCT03911960|EG000|Reported Event|Acceptance and Commitment Therapy|"2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch.~Acceptance and Commitment Therapy: 2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch"
11353111|NCT03911960|EG001|Reported Event|Enhanced Usual Care|"2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch~Enhanced Usual Care: 2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline."
11353112|NCT03907072|BG000|Baseline|WVE-210201 (3 mg/kg)|WVE-210201 (suvodirsen): WVE-210201 is a stereopure antisense oligonucleotide (ASO)
11353113|NCT03907072|BG001|Baseline|WVE-210201 (4.5 mg/kg)|WVE-210201 (suvodirsen): WVE-210201 is a stereopure antisense oligonucleotide (ASO)
11353114|NCT03907072|BG002|Baseline|Placebo|Placebo: Buffered saline solution
11353115|NCT03907072|BG003|Baseline|Total|Total of all reporting groups
11353116|NCT03907072|FG000|Participant Flow|WVE-210201 (3 mg/kg)|WVE-210201 (suvodirsen): WVE-210201 is a stereopure antisense oligonucleotide (ASO)
11353117|NCT03907072|FG001|Participant Flow|WVE-210201 (4.5 mg/kg)|WVE-210201 (suvodirsen): WVE-210201 is a stereopure antisense oligonucleotide (ASO)
11353118|NCT03907072|FG002|Participant Flow|Placebo|Placebo: Buffered saline solution
11353119|NCT03907072|OG000|Outcome|WVE-210201 (3 mg/kg)|WVE-210201 (suvodirsen): WVE-210201 is a stereopure antisense oligonucleotide (ASO)
11353120|NCT03907072|OG001|Outcome|WVE-210201 (4.5 mg/kg)|WVE-210201 (suvodirsen): WVE-210201 is a stereopure antisense oligonucleotide (ASO)
11353121|NCT03907072|OG002|Outcome|Placebo|Placebo: Buffered saline solution
11353122|NCT03907072|EG000|Reported Event|WVE-210201 (3 mg/kg)|WVE-210201 (suvodirsen): WVE-210201 is a stereopure antisense oligonucleotide (ASO)
11353123|NCT03907072|EG001|Reported Event|WVE-210201 (4.5 mg/kg)|WVE-210201 (suvodirsen): WVE-210201 is a stereopure antisense oligonucleotide (ASO)
11353124|NCT03907072|EG002|Reported Event|Placebo|Placebo: Buffered saline solution
11353125|NCT03906448|BG000|Baseline|Astrocytoma Patients|"Patients newly diagnosed with Grade II and III astrocytoma.~TTFields with adjuvant temozolomide: Patients will begin study treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will be given, depending on tolerability and toxicity."
11353126|NCT03906448|BG001|Baseline|Control Arm|Data collection from medical record only
11353127|NCT03906448|BG002|Baseline|Total|Total of all reporting groups
11353128|NCT03906448|FG000|Participant Flow|Astrocytoma Patients|"Patients newly diagnosed with Grade II and III astrocytoma.~TTFields with adjuvant temozolomide: Patients will begin study treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will be given, depending on tolerability and toxicity."
11353129|NCT03906448|FG001|Participant Flow|Control Arm|Data collection from medical record only
11167615|NCT01980888|FG000|Participant Flow|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
11092167|NCT01537666|OG001|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
11092168|NCT01537666|EG000|Reported Event|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
11092169|NCT01537666|EG001|Reported Event|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
11092170|NCT01537666|EG002|Reported Event|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
11092171|NCT01537666|EG003|Reported Event|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
11092172|NCT01537666|EG004|Reported Event|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
11092173|NCT01537666|EG005|Reported Event|IV Vancomycin 250 mg in Healthy Volunteers|Comprised of 2 patients from each of the AeroVanc in Healthy Volunteer groups.
11092174|NCT01537783|BG000|Baseline|Intervention Group|Standard emergency department care plus eradication protocol
11092175|NCT01537783|BG001|Baseline|Standard of Care|Standard emergency department care
11092176|NCT01537783|BG002|Baseline|Total|Total of all reporting groups
11092177|NCT01537783|FG000|Participant Flow|Standard of Care|Usual emergency department care
11092178|NCT01537783|FG001|Participant Flow|Intervention|Usual emergency department care plus eradication protocol
11092179|NCT01537783|OG000|Outcome|Intervention Group|"In this arm, patients are treated with chlorhexidine scrubs once a day for 5 days and mupirocin nasal ointment inserted to both nostrils twice a day for 5 days. Both treatments are begun 7 days after enrollment, or when the abscess has healed fully if it has not healed by day 7.~Chlorhexidine gluconate: Scrubs applied once a day for 5 days~Mupirocin: Nasal mupirocin applied topically to both nostrils twice a day for 5 days"
11092180|NCT01537783|OG001|Outcome|Standard of Care|In this arm, patients receive routine care of their abscess, which may or may not include either topical or oral antibiotics, at the discretion of the treating clinician.
11092181|NCT01537783|EG000|Reported Event|Intervention Group|Standard emergency department care plus eradication protocol
11092182|NCT01537783|EG001|Reported Event|Standard of Care|Standard emergency department care
11092183|NCT01537835|BG000|Baseline|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
11092184|NCT01537835|BG001|Baseline|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
11092185|NCT01537835|BG002|Baseline|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
11092186|NCT01537835|BG003|Baseline|Total|Total of all reporting groups
11092187|NCT01537835|FG000|Participant Flow|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
11092188|NCT01537835|FG001|Participant Flow|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
11092189|NCT01537835|FG002|Participant Flow|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
11092190|NCT01537835|OG000|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
11092191|NCT01537835|OG001|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
11092192|NCT01537835|OG002|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
11092193|NCT01537835|EG000|Reported Event|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
11353130|NCT03906448|OG000|Outcome|Astrocytoma Patients|"Patients newly diagnosed with Grade II and III astrocytoma.~TTFields with adjuvant temozolomide: Patients will begin study treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will be given, depending on tolerability and toxicity."
11353131|NCT03906448|OG001|Outcome|Control Arm|Data collection from medical record only
11353132|NCT03906448|EG000|Reported Event|Astrocytoma Patients|"Patients newly diagnosed with Grade II and III astrocytoma.~TTFields with adjuvant temozolomide: Patients will begin study treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will be given, depending on tolerability and toxicity."
11353133|NCT03906448|EG001|Reported Event|Control Arm|Data collection from medical record only
11353134|NCT03911401|BG000|Baseline|0.3% OPA-15406|Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
11353135|NCT03911401|BG001|Baseline|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11353136|NCT03911401|BG002|Baseline|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
11353137|NCT03911401|BG003|Baseline|Total|Total of all reporting groups
11353138|NCT03911401|FG000|Participant Flow|0.3% OPA-15406|Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
11353139|NCT03911401|FG001|Participant Flow|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11353140|NCT03911401|FG002|Participant Flow|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
11353141|NCT03911401|OG000|Outcome|0.3% OPA-15406|Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
11353142|NCT03911401|OG001|Outcome|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11353143|NCT03911401|OG002|Outcome|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
11353144|NCT03911401|EG000|Reported Event|0.3% OPA-15406|Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
10887914|NCT00503776|OG003|Outcome|Arm IIB|"Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.~exercise intervention: Patients undergo low weight resistance training.~amifostine trihydrate: Given subcutaneously~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
10887915|NCT00503776|EG000|Reported Event|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
11353145|NCT03911401|EG001|Reported Event|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11353146|NCT03911401|EG002|Reported Event|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
11353147|NCT03909763|BG000|Baseline|Berberine Plus Danazol|"Berberine plus danazol group~Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks"
11353148|NCT03909763|FG000|Participant Flow|Berberine Plus Danazol|"Berberine plus danazol group~Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks"
11353149|NCT03909763|OG000|Outcome|Berberine Plus Danazol|"Berberine plus danazol group~Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks"
11353150|NCT03909763|EG000|Reported Event|Berberine Plus Danazol|"Berberine plus danazol group~Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks"
11353151|NCT03909009|BG000|Baseline|Active rTMS|Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS) A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).
11353152|NCT03909009|BG001|Baseline|Sham rTMS|Group 2 will receive sham stimulation. A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).
11353153|NCT03909009|BG002|Baseline|Total|Total of all reporting groups
11353154|NCT03909009|FG000|Participant Flow|Active rTMS|Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS) A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).
11353155|NCT03909009|FG001|Participant Flow|Sham rTMS|Group 2 will receive sham stimulation. A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).
11353156|NCT03909009|OG000|Outcome|Active rTMS|Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS) A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).
11353157|NCT03909009|OG001|Outcome|Sham rTMS|Group 2 will receive sham stimulation. A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).
11353158|NCT03909009|EG000|Reported Event|Active rTMS|"Group 1 will receive HF rTMS treatment daily from Monday to Friday in first 2 weeks. After first 2 weeks there will be sessions once a week for 1 month.~There will be 14 sessions in total.~rTMS + Neuronavigation: Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator"
11353159|NCT03909009|EG001|Reported Event|Sham rTMS|"Group 2 will receive sham daily from Monday to Friday in first 2 weeks. After first 2 weeks there will be sessions once a week for 1 month.~There will be 14 sham sessions in total.~rTMS + Neuronavigation: Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator"
11353160|NCT03906968|BG000|Baseline|SinuSonic Device|"SinuSonic Device used twice a day for four to six weeks.~SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion"
11353161|NCT03906968|FG000|Participant Flow|SinuSonic Device|"SinuSonic Device used twice a day for four to six weeks.~SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion"
11353162|NCT03906968|OG000|Outcome|SinuSonic Device|"SinuSonic Device used twice a day for four to six weeks.~SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion"
11353163|NCT03906968|EG000|Reported Event|SinuSonic Device|"SinuSonic Device used twice a day for four to six weeks.~SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion"
11353164|NCT03904420|BG000|Baseline|Group A - New Model|"Standardized programming and testing method~Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches"
11353165|NCT03904420|BG001|Baseline|Group B - Traditional Model|"Traditional clinical model which is not standardized across clinical sites~Traditional Model: Standard clinical practice and education"
11353166|NCT03904420|BG002|Baseline|Total|Total of all reporting groups
11353167|NCT03904420|FG000|Participant Flow|Group A - New Model|"Standardized programming and testing method~Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches"
11353168|NCT03904420|FG001|Participant Flow|Group B - Traditional Model|"Traditional clinical model which is not standardized across clinical sites~Traditional Model: Standard clinical practice and education"
11353169|NCT03904420|OG000|Outcome|Group A - New Model|"Standardized programming and testing method~Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches"
11353170|NCT03904420|OG001|Outcome|Group B - Traditional Model|"Traditional clinical model which is not standardized across clinical sites~Traditional Model: Standard clinical practice and education"
11353171|NCT03904420|EG000|Reported Event|Group A - New Model|"Standardized programming and testing method~Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches"
11353172|NCT03904420|EG001|Reported Event|Group B - Traditional Model|"Traditional clinical model which is not standardized across clinical sites~Traditional Model: Standard clinical practice and education"
11353173|NCT03903822|BG000|Baseline|Vehicle Cream Once Daily (QD)|Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353174|NCT03903822|BG001|Baseline|PF-06700841 0.1% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353175|NCT03903822|BG002|Baseline|PF-06700841 0.3% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353176|NCT03903822|BG003|Baseline|PF-06700841 1.0% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353177|NCT03903822|BG004|Baseline|PF-06700841 3.0% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353178|NCT03903822|BG005|Baseline|Vehicle Cream Twice Daily (BID)|Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353179|NCT03903822|BG006|Baseline|PF-06700841 0.3% Cream BID|Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353180|NCT03903822|BG007|Baseline|PF-06700841 1.0% Cream BID|Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11167616|NCT01980888|FG001|Participant Flow|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
10887916|NCT00503776|EG001|Reported Event|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
11167617|NCT01980888|OG000|Outcome|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
11167618|NCT01980888|OG001|Outcome|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
11353181|NCT03903822|BG008|Baseline|Total|Total of all reporting groups
11353182|NCT03903822|FG000|Participant Flow|Vehicle Cream Once Daily (QD)|Participants or caregivers of participants, topically applied vehicle cream on all eligible atopic dermatitis (AD) areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353183|NCT03903822|FG001|Participant Flow|PF-06700841 0.1% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 0.1 percent (%) cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353184|NCT03903822|FG002|Participant Flow|PF-06700841 0.3% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11231089|NCT02411084|EG001|Reported Event|Conventional Second-line Treatment|"The most frequent adverse events recorded in the conventional treatment arm were peripheral edema(22.2% cases), pyrexia (19.4% cases). Cytomegalovirus infection was found in 13.9% cases.There were recorded 29 serious adverse events. At Day 28, death occurred in 11.1% cases in this treatment group. At the end of the study rate of serious adverse events which determined early discontinuation in conventional treatment arm was 5.6~% (one subject). Mortality (approx. day 180) was 22.2 % (8 subjects) in the conventional treatment group."
11231090|NCT02411110|BG000|Baseline|LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)|Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
11231091|NCT02411110|BG001|Baseline|LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)|Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
11231092|NCT02411110|BG002|Baseline|Total|Total of all reporting groups
11231093|NCT02411110|FG000|Participant Flow|LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)|Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
11231094|NCT02411110|FG001|Participant Flow|LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)|Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
11231095|NCT02411110|OG000|Outcome|LiRIS® (Treatment Period 1)|Treatment Period 1: LiRIS® (continuous release of lidocaine ) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
11231096|NCT02411110|OG001|Outcome|LiRIS Placebo (Treatment Period 1)|Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
11231097|NCT02411110|EG000|Reported Event|LiRIS Placebo (Treatment Period 1)|Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
11231098|NCT02411110|EG001|Reported Event|LiRIS® (Treatment Period 1)|Treatment Period 1: LiRIS® (continuous release of lidocaine ) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
11231099|NCT02411110|EG002|Reported Event|LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)|Participants who received Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
11231100|NCT02411110|EG003|Reported Event|LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)|Participants who received LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
11231101|NCT02411201|BG000|Baseline|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
11231102|NCT02411201|FG000|Participant Flow|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
11231103|NCT02411201|OG000|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
11231104|NCT02411201|OG000|Outcome|Pre-contrast|Lesion visualization was assessed before DOTAREM injection
11231105|NCT02411201|OG001|Outcome|Pre- + Post-contrast|Lesion visualization was assessed after DOTAREM injection
11231106|NCT02411201|EG000|Reported Event|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
11231107|NCT02411292|BG000|Baseline|Enoxaparin Metabolism|"Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.~Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists."
11231108|NCT02411292|FG000|Participant Flow|Enoxaparin Metabolism|"Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.~Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists."
11231109|NCT02411292|OG000|Outcome|Low aFXa Level|Patients with a low Anti-Factor Xa Level as identified after the third administration of enoxaparin
11231110|NCT02411292|OG001|Outcome|In-Range or High aFXa Level|Patients with an in-range or high Anti-Factor Xa Level as identified after the third administration of enoxaparin
10887917|NCT00503776|EG002|Reported Event|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
11231111|NCT02411292|OG000|Outcome|Enoxaparin Metabolism|Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
11231112|NCT02411292|EG000|Reported Event|Enoxaparin Metabolism|"Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.~Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists."
11231113|NCT02411396|BG000|Baseline|VOC in Patients With SCD|Patients treated for uncomplicated VOC in ICs and EDs.
11231114|NCT02411396|FG000|Participant Flow|Vaso-Occlusive Crisis (VOC) in Patients With SCD|Patients treated for uncomplicated Vaso-Occlusive Crisis (VOC) in ICs and EDs.
11231115|NCT02411396|OG000|Outcome|VOC in Patients With SCD Who Went to EDs|Patients treated for uncomplicated VOC in EDs.
11231116|NCT02411396|OG001|Outcome|VOC in Patients With SCD Who Went to ICs|Patients treated for uncomplicated VOC in ICs
11231117|NCT02411396|OG000|Outcome|VOC in Patients With SCD Who Went to the ED|VOC in Patients with SCD that went to the ED
11231118|NCT02411396|OG001|Outcome|VOC in Patients With SCD Who Went to the IC|VOC in patients with SCD that went to the IC
11231119|NCT02411396|OG000|Outcome|VOC in Patients With SCD Who Went to ED|Patients treated for uncomplicated VOC in EDs
11231120|NCT02411396|OG001|Outcome|VOC in Patients With SCD Who Went to IC|Patients treated for uncomplicated VOC in ICs
11231121|NCT02411396|EG000|Reported Event|VOC in Patients With SCD|Patients treated for uncomplicated VOC in ICs and EDs
11231122|NCT02411461|BG000|Baseline|Pseudohypoparathyroidism Type 1a|Study group
11231123|NCT02411461|BG001|Baseline|Healthy Siblings|Control group
11231124|NCT02411461|BG002|Baseline|Obese Patients|Control group
11231125|NCT02411461|BG003|Baseline|Total|Total of all reporting groups
11231126|NCT02411461|FG000|Participant Flow|Pseudohypoparathyroidism Type 1a|Study group
11231127|NCT02411461|FG001|Participant Flow|Healthy Siblings|Control group
11231128|NCT02411461|FG002|Participant Flow|Obese Patients|Control group
11231129|NCT02411461|OG000|Outcome|Pseudohypoparathyroidism Type 1a|Study group
11231130|NCT02411461|OG001|Outcome|Healthy Siblings|Control group
11231131|NCT02411461|OG002|Outcome|Obese Patients|Control group
11231132|NCT02411461|EG000|Reported Event|Pseudohypoparathyroidism Type 1a|Study group
11231133|NCT02411461|EG001|Reported Event|Healthy Siblings|Control group
11231134|NCT02411461|EG002|Reported Event|Obese Patients|Control group
11231135|NCT02411539|BG000|Baseline|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231136|NCT02411539|BG001|Baseline|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231137|NCT02411539|BG002|Baseline|Total|Total of all reporting groups
11231138|NCT02411539|FG000|Participant Flow|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231139|NCT02411539|FG001|Participant Flow|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231140|NCT02411539|OG000|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231141|NCT02411539|OG001|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231142|NCT02411539|OG000|Outcome|Across Arms|Compare the pre-VRC01 and post-VRC01 time points across randomized Arms A/B. Arm A participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. Arm B participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. This group is to identify analyses that were assessed across randomized arms between the pre- and post-VRC01 time points.
11335566|NCT03552549|EG000|Reported Event|PEG-Intron|Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery
11231143|NCT02411539|OG000|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231144|NCT02411539|OG001|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231145|NCT02411539|EG000|Reported Event|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231146|NCT02411539|EG001|Reported Event|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
11231147|NCT02411565|BG000|Baseline|Fermented Wheat Germ Extract (FWGE)|FWGE administration 2-4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O
11231148|NCT02411565|BG001|Baseline|Placebo Administration|Placebo administration 2-4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O
11231149|NCT02411565|BG002|Baseline|Total|Total of all reporting groups
11231150|NCT02411565|FG000|Participant Flow|Fermented Wheat Germ Extract (FWGE)|FWGE administration 2 - 4 weeks prior to planned surgery.
11231151|NCT02411565|FG001|Participant Flow|Placebo Administration|Placebo administration 2 - 4 weeks prior to planned surgery.
11231152|NCT02411565|OG000|Outcome|Fermented Wheat Germ Extract (FWGE)|FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
11231153|NCT02411565|OG001|Outcome|Placebo Administration|Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
11231154|NCT02411565|EG000|Reported Event|Fermented Wheat Germ Extract (FWGE)|FWGE administration 2 - 4 weeks prior to planned surgery.
11231155|NCT02411565|EG001|Reported Event|Placebo Administration|Placebo administration 2 - 4 weeks prior to planned surgery.
11231156|NCT02411578|BG000|Baseline|G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
10887918|NCT00503776|EG003|Reported Event|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
11231157|NCT02411578|BG001|Baseline|Glucose Tabs, Then G-Pen Mini|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
11231158|NCT02411578|BG002|Baseline|Total|Total of all reporting groups
10887919|NCT00503867|BG000|Baseline|Hepatic Arterial Radioembolization SIR-Spheres Microspheres|"SIR-Spheres microspheres~SIR-Spheres microspheres: SIR-Spheres Yttrium-90 microspheres"
11335567|NCT03552549|EG001|Reported Event|INTRON A|Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery
11335568|NCT03552757|BG000|Baseline|Semaglutide 1.0 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11353185|NCT03903822|FG003|Participant Flow|PF-06700841 1.0% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353186|NCT03903822|FG004|Participant Flow|PF-06700841 3.0% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353187|NCT03903822|FG005|Participant Flow|Vehicle Cream Twice Daily (BID)|Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353188|NCT03903822|FG006|Participant Flow|PF-06700841 0.3% Cream BID|Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353189|NCT03903822|FG007|Participant Flow|PF-06700841 1.0% Cream BID|Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353190|NCT03903822|OG000|Outcome|Vehicle Cream Once Daily (QD)|Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353191|NCT03903822|OG001|Outcome|PF-06700841 0.1% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353192|NCT03903822|OG002|Outcome|PF-06700841 0.3% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353193|NCT03903822|OG003|Outcome|PF-06700841 1.0% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353194|NCT03903822|OG004|Outcome|PF-06700841 3.0% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353195|NCT03903822|OG005|Outcome|Vehicle Cream Twice Daily (BID)|Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353196|NCT03903822|OG006|Outcome|PF-06700841 0.3% Cream BID|Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353197|NCT03903822|OG007|Outcome|PF-06700841 1.0% Cream BID|Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353198|NCT03903822|EG000|Reported Event|Vehicle Cream Once Daily (QD)|Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353199|NCT03903822|EG001|Reported Event|PF-06700841 0.1% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353200|NCT03903822|EG002|Reported Event|PF-06700841 0.3% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353201|NCT03903822|EG003|Reported Event|PF-06700841 1.0% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353202|NCT03903822|EG004|Reported Event|PF-06700841 3.0% Cream QD|Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353203|NCT03903822|EG005|Reported Event|Vehicle Cream Twice Daily (BID)|Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353204|NCT03903822|EG006|Reported Event|PF-06700841 0.3% Cream BID|Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11231159|NCT02411578|FG000|Participant Flow|G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
11231160|NCT02411578|FG001|Participant Flow|Glucose Tabs, Then G-Pen Mini|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
11231161|NCT02411578|OG000|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
11231162|NCT02411578|OG001|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
11231163|NCT02411578|OG000|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study BG meter (BGM) if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
11231164|NCT02411578|OG000|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
11231165|NCT02411578|EG000|Reported Event|G-Pen Mini™ (Glucagon Injection)|Participants treat non-severe hypoglycemic events with glucagon.
11231166|NCT02411578|EG001|Reported Event|Glucose Tabs|Participants treat non-severe hypoglycemic events with glucose tabs.
11231167|NCT02411591|BG000|Baseline|Cohort 1 (Necitumumab 800 mg + Abemaciclib 100 mg)|Part A: Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 100 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231168|NCT02411591|BG001|Baseline|Cohort 2 (Necitumumab 800 mg + Abemaciclib 150 mg)|"Part A: Necitumumab administered intravenously (IV) on Days 1 and 8, followed by abemaciclib given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.~Part B (expansion cohort) : Necitumumab administered IV on Days 1 and 8, followed by abemaciclib given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met."
11167619|NCT01980888|EG000|Reported Event|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
11167620|NCT01980888|EG001|Reported Event|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
11167621|NCT01980914|BG000|Baseline|Diabetic Patients|"We are aim to recruit group of 20 diabetic patients with type 2 diabetes over age 70, who are being treated with insulin.~However, only 11 patients were enrolled.~1 subject had experienced AE due to to skin irritation. 11 subjects have completed study."
11167622|NCT01980914|FG000|Participant Flow|Diabetic Patients|Patients over age 70 who have had type 2 diabetes for at least 5 years and are being treated with insulin. All patients will have a BMI of between 20 and 35 Kg/M2, and an A1C between 7 and 8.5 %. All patients will have well controlled hypertension and hyperlipidemia
11167623|NCT01980914|OG000|Outcome|Diabetic Patients|"We are aim to recruit group of 20 diabetic patients with type 2 diabetes over age 70, who are being treated with insulin.~However, only 11 patients were enrolled.~1 subject withdrew after 24 hours due to skin irritation. 10 subjects have completed study."
11167624|NCT01980914|OG000|Outcome|Type 2 Diabetes Group|"Patients over age 70 who have had type 2 diabetes for at least 5 years and are being treated with insulin. All patients will have a BMI of between 20 and 35 Kg/M2, and an A1C between 7 and 8.5 %.~iPro2 glucose sensor attachment: At the same time the glucose sensor is started, a trained research nurse will connect the patient to an Icentia CardioSTAT, a continuous ambulatory ECG cardiac monitor."
11167625|NCT01980914|EG000|Reported Event|Diabetic Patients|"We are aim to recruit group of 20 diabetic patients with type 2 diabetes over age 70, who are being treated with insulin.~However, only 11 patients were enrolled.~1 subject withdrew after 24 hours due to skin irritation. 10 subjects have completed study."
11167626|NCT01980992|BG000|Baseline|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
11167627|NCT01980992|BG001|Baseline|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
11167628|NCT01980992|BG002|Baseline|Total|Total of all reporting groups
11167629|NCT01980992|FG000|Participant Flow|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
11167630|NCT01980992|FG001|Participant Flow|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
11167631|NCT01980992|OG000|Outcome|Placebo|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
11167632|NCT01980992|OG001|Outcome|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
11167633|NCT01980992|OG000|Outcome|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
11167634|NCT01980992|OG000|Outcome|Wheat OIT Before 1 Year|During the first year of 2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
11167635|NCT01980992|OG001|Outcome|Placebo Before 1 Year|During the first year of 52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
11167636|NCT01980992|OG002|Outcome|Wheat OIT After 1 Year|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
11167637|NCT01980992|OG003|Outcome|Placebo Crossover|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
10887920|NCT00503867|FG000|Participant Flow|SIR-Spheres Microspheres|Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.
11167638|NCT01980992|EG000|Reported Event|Wheat OIT Before 1 Year|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
11167639|NCT01980992|EG001|Reported Event|Placebo Before 1 Year|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
11167640|NCT01980992|EG002|Reported Event|Wheat OIT After 1 Year|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
11167641|NCT01980992|EG003|Reported Event|Placebo Crossover|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
11167642|NCT01981057|BG000|Baseline|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
11167643|NCT01981057|BG001|Baseline|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
11167644|NCT01981057|BG002|Baseline|Total|Total of all reporting groups
11167645|NCT01981057|FG000|Participant Flow|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
11167646|NCT01981057|FG001|Participant Flow|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
11167647|NCT01981057|OG000|Outcome|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
11167648|NCT01981057|OG001|Outcome|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
11167649|NCT01981057|EG000|Reported Event|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
10887921|NCT00503867|OG000|Outcome|SIR-Spheres Microspheres|Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.
11167650|NCT01981057|EG001|Reported Event|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
11167651|NCT01981109|BG000|Baseline|Sipuleucel-T|A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
11167652|NCT01981109|FG000|Participant Flow|Sipuleucel-T|A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
11167653|NCT01981109|OG000|Outcome|M0- No Distant Metastases|A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
11167654|NCT01981109|OG001|Outcome|M1-Distant Metastases|A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
11167655|NCT01981109|EG000|Reported Event|Sipuleucel-T|A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
11167656|NCT01981122|BG000|Baseline|Concurrent Arm|"Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily."
11167657|NCT01981122|BG001|Baseline|Sequential Arm|"Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily."
11167658|NCT01981122|BG002|Baseline|Total|Total of all reporting groups
11167659|NCT01981122|FG000|Participant Flow|Concurrent Arm|"Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily."
11167660|NCT01981122|FG001|Participant Flow|Sequential Arm|"Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily."
11167661|NCT01981122|OG000|Outcome|Concurrent Arm|"Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily."
11167662|NCT01981122|OG001|Outcome|Sequential Arm|"Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily."
11167663|NCT01981122|EG000|Reported Event|Concurrent Arm|"Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily."
11167664|NCT01981122|EG001|Reported Event|Sequential Arm|"Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~enzalutamide: Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily."
11167665|NCT01981187|BG000|Baseline|LGX818 (Encorafenib)|Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately.
11167666|NCT01981187|FG000|Participant Flow|LGX818 (Encorafenib)|Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately.
11167667|NCT01981187|OG000|Outcome|LGX818 (Encorafenib)|Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately.
11167668|NCT01981187|EG000|Reported Event|LGX818 (Encorafenib)|Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately.
11167669|NCT01981356|BG000|Baseline|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
11167670|NCT01981356|BG001|Baseline|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
11167671|NCT01981356|BG002|Baseline|Total|Total of all reporting groups
11167672|NCT01981356|FG000|Participant Flow|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
11167673|NCT01981356|FG001|Participant Flow|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
11167674|NCT01981356|OG000|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
11167675|NCT01981356|OG001|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
11167676|NCT01981356|OG000|Outcome|Inpatient Psychiatry Unit Staff Members|Barriers and facilitators were assessed through interviews of four inpatient psychiatry unit staff (on nursing assistant, one nurse, two psychologists).
11167677|NCT01981356|EG000|Reported Event|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
11167678|NCT01981356|EG001|Reported Event|Treatment as Usual (TAU)|"TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.~Treatment as Usual (TAU): All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate."
11167679|NCT01981473|BG000|Baseline|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167680|NCT01981473|BG001|Baseline|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167681|NCT01981473|BG002|Baseline|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167682|NCT01981473|BG003|Baseline|Total|Total of all reporting groups
11167683|NCT01981473|FG000|Participant Flow|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167684|NCT01981473|FG001|Participant Flow|Adalimumab|Participants who had received treatment with Adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167685|NCT01981473|FG002|Participant Flow|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167686|NCT01981473|OG000|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167687|NCT01981473|OG001|Outcome|Adalimumab/ Infliximab|Participants who had received treatment with adalimumab or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167688|NCT01981473|OG000|Outcome|% AA+|Proportion of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
11167689|NCT01981473|OG001|Outcome|% AA-|Proportion of participants negative for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
11167690|NCT01981473|OG001|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167691|NCT01981473|OG002|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167692|NCT01981473|EG000|Reported Event|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167693|NCT01981473|EG001|Reported Event|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11231169|NCT02411591|BG002|Baseline|Cohort 3 (Necitumumab 800 mg + Abemaciclib 200 mg)|Part A: Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 200 mg given orally Q12H on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231170|NCT02411591|BG003|Baseline|Total|Total of all reporting groups
11231171|NCT02411591|FG000|Participant Flow|Cohort 1 (Necitumumab 800 mg + Abemaciclib 100 mg)|Part A: Necitumumab 800 milligram (mg) was administered intravenously (IV) on Days 1 and 8, followed by abemaciclib 100 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231172|NCT02411591|FG001|Participant Flow|Cohort 2 (Necitumumab 800 mg + Abemaciclib 150 mg)|"Part A: Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.~Part B: (expansion cohort): Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met."
11231173|NCT02411591|FG002|Participant Flow|Cohort 3 (Necitumumab 800 mg + Abemaciclib 200 mg)|Part A: Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 200 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231174|NCT02411591|OG000|Outcome|Cohort 1 (Necitumumab 800 mg + Abemaciclib 100 mg)|Part A: Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 100 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231175|NCT02411591|OG001|Outcome|Cohort 2 (Necitumumab 800 mg + Abemaciclib 150 mg)|Part A: Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231176|NCT02411591|OG002|Outcome|Cohort 3 (Necitumamab 800 mg + Abemaciclib 200 mg)|Part A: Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 200 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231177|NCT02411591|OG001|Outcome|Cohort 2 (Necitumumab 800 mg + Abemaciclib 150 mg)|"Part A: Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.~Part B (expansion cohort): Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met."
11231178|NCT02411591|OG002|Outcome|Cohort 3 (Necitumumab 800 mg + Abemaciclib 200 mg)|Part A: Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 200 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231179|NCT02411591|OG001|Outcome|Cohort 2 (Necitumumab 800 mg + Abemaciclib 150 mg)|"Part A: Necitumumab 800 mg administered intravenously (IV) on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.~Part B (expansion cohort): Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met."
11231180|NCT02411591|OG003|Outcome|Total Enrolled Participants (Necitumumab + Abemaciclib)|Cohorts 1, 2 and 3 combined. Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 100 mg, 150 mg or 200 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231181|NCT02411591|OG000|Outcome|Necitumumab|Necitumumab 800 mg was administered IV on Days 1 and 8, of a 3-week cycle.
11231182|NCT02411591|OG000|Outcome|Abemaciclib 100 mg|Necitumumab 800 mg administered IV on Days 1 and 8 followed by abemaciclib 100 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231183|NCT02411591|OG001|Outcome|Abemaciclib 150 mg|Necitumumab 800 mg administered IV on Days 1 and 8 followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231184|NCT02411591|OG002|Outcome|Abemaciclib 200 mg|Necitumumab 800 mg administered IV on Days 1 and 8 followed by abemaciclib 200 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231185|NCT02411591|EG000|Reported Event|Necitumumab 800 mg + Abemaciclib 100 mg|Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 100 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231186|NCT02411591|EG001|Reported Event|Necitumumab 800 mg + Abemaciclib 150 mg|Necitumumab 800 mg administered intravenously (IV) on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231187|NCT02411591|EG002|Reported Event|Necitumumab 800 mg + Abemaciclib 200 mg|Necitumumab 800 mg was administered IV on Days 1 and 8, followed by abemaciclib 200 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.
11231188|NCT02411747|BG000|Baseline|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with a expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
11231189|NCT02411747|BG001|Baseline|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy by simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
11231190|NCT02411747|BG002|Baseline|Total|Total of all reporting groups
11231191|NCT02411747|FG000|Participant Flow|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
11167694|NCT01981473|EG002|Reported Event|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
11167695|NCT01981564|BG000|Baseline|Asthma Express Intervention|"Clinic visit for asthma education + nurse home visits~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
11167696|NCT01981564|BG001|Baseline|Standard ASthma Education Control Group|"STandard asthma education delivered in home by nurse~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
11167697|NCT01981564|BG002|Baseline|Total|Total of all reporting groups
11167698|NCT01981564|FG000|Participant Flow|Asthma Express Intervention|"Clinic visit for asthma education + nurse home visits~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
11167699|NCT01981564|FG001|Participant Flow|Standard ASthma Education Control Group|"STandard asthma education delivered in home by nurse~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
11167700|NCT01981564|OG000|Outcome|Asthma Express Intervention|Asthma Express clinic visit for asthma education + nurse home visit
11167701|NCT01981564|OG001|Outcome|Standard ASthma Education Control Group|Asthma Express home nurse visits for asthma education
11231192|NCT02411747|FG001|Participant Flow|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
11167702|NCT01981564|OG001|Outcome|Standard Asthma Education Control Group|Asthma Express home nurse visits for asthma education
11167703|NCT01981564|EG000|Reported Event|Asthma Express Intervention|"Clinic visit for asthma education + nurse home visits~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
11167704|NCT01981564|EG001|Reported Event|Standard ASthma Education Control Group|"STandard asthma education delivered in home by nurse~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
11167705|NCT01981590|BG000|Baseline|Phrenic Nerve Stimulation|"Intravenously stimulating the phrenic nerve~Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.: Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator."
11167706|NCT01981590|FG000|Participant Flow|Phrenic Nerve Stimulation|"Intravenously stimulating the phrenic nerve~Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.: Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator."
11167707|NCT01981590|OG000|Outcome|Patients With Phrenic Nerve Stimulation Achieved|Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
11167708|NCT01981590|OG000|Outcome|Patients With Observed Side Effects|All Patients enrolled in the study that underwent an atrial flutter or atrial fibrillation ablation procedure with observed side effects
11167709|NCT01981590|EG000|Reported Event|Phrenic Nerve Stimulation|"Intravenously stimulating the phrenic nerve~Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.: Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator."
11167710|NCT01981616|BG000|Baseline|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
11167711|NCT01981616|BG001|Baseline|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
11167712|NCT01981616|BG002|Baseline|Total|Total of all reporting groups
11167713|NCT01981616|FG000|Participant Flow|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
11167714|NCT01981616|FG001|Participant Flow|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
11167715|NCT01981616|OG000|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
11167716|NCT01981616|OG001|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
11167717|NCT01981616|EG000|Reported Event|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
11167718|NCT01981616|EG001|Reported Event|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
11167719|NCT01981759|BG000|Baseline|Placebo|"Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).~Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12."
11231193|NCT02411747|OG000|Outcome|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
11231194|NCT02411747|OG001|Outcome|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
11231195|NCT02411747|EG000|Reported Event|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
11231196|NCT02411747|EG001|Reported Event|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
11231197|NCT02411916|BG000|Baseline|Intervention Cases|patient receiving misoprostol (rectal insertion)
11231198|NCT02411916|BG001|Baseline|Controls|patients not receiving misoprostol
11231199|NCT02411916|BG002|Baseline|Total|Total of all reporting groups
11231200|NCT02411916|FG000|Participant Flow|Intervention Cases|"patient receiving misoprostol~misoprostol: rectal insertion"
11231201|NCT02411916|FG001|Participant Flow|Controls|patients not receiving misoprostol
11231202|NCT02411916|OG000|Outcome|Intervention Cases|"patient receiving misoprostol~misoprostol: rectal insertion"
11231203|NCT02411916|OG001|Outcome|Controls|patients not receiving misoprostol
11231204|NCT02411916|EG000|Reported Event|Intervention Cases|"patient receiving misoprostol~misoprostol: rectal insertion"
11231205|NCT02411916|EG001|Reported Event|Controls|patients not receiving misoprostol
11231206|NCT02411929|BG000|Baseline|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
11231207|NCT02411929|FG000|Participant Flow|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
11231208|NCT02411929|OG000|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
11231209|NCT02411929|OG001|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
11231210|NCT02411929|OG000|Outcome|14^C-Ertugliflozin 100 ug Oral|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C administered orally after the unlabeled oral dose (no more than 5 minutes apart) on Day 1 of Period 2.
11231211|NCT02411929|OG000|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
11231212|NCT02411929|OG001|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
11231213|NCT02411929|EG000|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
11231214|NCT02411929|EG001|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart.)
11231215|NCT02412098|BG000|Baseline|Moderate Hepatic Impairment (Cohort 1)|Participants with moderate hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231216|NCT02412098|BG001|Baseline|Mild Hepatic Impairment (Cohort 3)|Participants with mild hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231217|NCT02412098|BG002|Baseline|Normal Hepatic Function|Participants with normal hepatic function received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231218|NCT02412098|BG003|Baseline|Total|Total of all reporting groups
11231219|NCT02412098|FG000|Participant Flow|Moderate Hepatic Impairment (Cohort 1)|Participants with moderate hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231220|NCT02412098|FG001|Participant Flow|Mild Hepatic Impairment (Cohort 3)|Participants with mild hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231221|NCT02412098|FG002|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231222|NCT02412098|OG000|Outcome|Moderate Hepatic Impairment (Cohort 1)|Participants with moderate hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11167720|NCT01981759|BG001|Baseline|D-Cycloserine|"Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).~Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12."
11167721|NCT01981759|BG002|Baseline|Total|Total of all reporting groups
11167722|NCT01981759|FG000|Participant Flow|Placebo|"Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).~Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12."
11167723|NCT01981759|FG001|Participant Flow|D-Cycloserine|"Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).~Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12."
11167724|NCT01981759|OG000|Outcome|Placebo|"Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).~Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12."
11167725|NCT01981759|OG001|Outcome|D-Cycloserine|"Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).~Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12."
11167726|NCT01981759|EG000|Reported Event|Placebo|"Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).~Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12."
11167727|NCT01981759|EG001|Reported Event|D-Cycloserine|"Participants will receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).~Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12."
11167728|NCT01981772|BG000|Baseline|Buffered Lidocaine|"administration of 4% buffered lidocaine with 1:100,000 epinephrine~4% buffered lidocaine with 1:100,000 epinephrine"
11167729|NCT01981772|BG001|Baseline|Nonbuffered Lidocaine|"administration of 4% lidocaine with 1:100,000 epinephrine~4% lidocaine with 1:100,000 epinephrine"
11167730|NCT01981772|BG002|Baseline|Total|Total of all reporting groups
11167731|NCT01981772|FG000|Participant Flow|Buffered Lidocaine|"administration of 4% buffered lidocaine with 1:100,000 epinephrine~4% buffered lidocaine with 1:100,000 epinephrine"
11167732|NCT01981772|FG001|Participant Flow|Nonbuffered Lidocaine|"administration of 4% lidocaine with 1:100,000 epinephrine~4% lidocaine with 1:100,000 epinephrine"
11167733|NCT01981772|OG000|Outcome|Buffered Lidocaine|"administration of 4% buffered lidocaine with 1:100,000 epinephrine~4% buffered lidocaine with 1:100,000 epinephrine"
11167734|NCT01981772|OG001|Outcome|Nonbuffered Lidocaine|"administration of 4% lidocaine with 1:100,000 epinephrine~4% lidocaine with 1:100,000 epinephrine"
11167735|NCT01981772|EG000|Reported Event|Buffered Lidocaine|"administration of 4% buffered lidocaine with 1:100,000 epinephrine~4% buffered lidocaine with 1:100,000 epinephrine"
11167736|NCT01981772|EG001|Reported Event|Nonbuffered Lidocaine|"administration of 4% lidocaine with 1:100,000 epinephrine~4% lidocaine with 1:100,000 epinephrine"
11174150|NCT02019927|OG002|Outcome|Multiple Sclerosis|"Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174151|NCT02019927|OG003|Outcome|Sham - Multiple Sclerosis|Sham treatment of decreased vision due to Multiple Sclerosis
11174152|NCT02019927|OG004|Outcome|Ocular Trauma|"Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174153|NCT02019927|OG005|Outcome|Sham - Ocular Trauma|Sham treatment of decreased vision due to ocular trauma
11174154|NCT02019927|OG001|Outcome|Sham - Non-arteritic Ischemic Optic Neuropathy (NAION)|Sham treatment of decreased vision due to NAION
11174155|NCT02019927|OG003|Outcome|Sham - Multiple Sclerosis (MS)|Sham treatment of decreased vision due to MS
11174156|NCT02019927|OG001|Outcome|Sham - NAION|Sham treatment of decreased vision due to NAION
11174157|NCT02019927|OG003|Outcome|Sham - Multiple Sclerosis|Sham treatment of decreased vision due to multiple sclerosis
11231223|NCT02412098|OG001|Outcome|Mild Hepatic Impairment (Cohort 3)|Participants with mild hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11167737|NCT01981863|BG000|Baseline|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
11167738|NCT01981863|BG001|Baseline|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
11167739|NCT01981863|BG002|Baseline|Total|Total of all reporting groups
11167740|NCT01981863|FG000|Participant Flow|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
11167741|NCT01981863|FG001|Participant Flow|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
11167742|NCT01981863|OG000|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
11167743|NCT01981863|OG001|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
11167744|NCT01981863|EG000|Reported Event|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.~No adverse advents to report."
11167745|NCT01981863|EG001|Reported Event|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm.~No adverse events to report."
11167746|NCT01981954|BG000|Baseline|Solifenacin Succinate|Children aged 6 months to less than 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
11167747|NCT01981954|FG000|Participant Flow|Solifenacin Succinate|Children aged 6 months to < 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
11167748|NCT01981954|OG000|Outcome|Solifenacin Succinate|Children aged 6 months to < 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
11167749|NCT01981954|EG000|Reported Event|Solifenacin Succinate|Children aged 6 months to < 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
11167750|NCT01981967|BG000|Baseline|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
11167751|NCT01981967|BG001|Baseline|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
11167752|NCT01981967|BG002|Baseline|Total|Total of all reporting groups
11167753|NCT01981967|FG000|Participant Flow|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
11167754|NCT01981967|FG001|Participant Flow|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
11167755|NCT01981967|OG000|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
11167756|NCT01981967|OG001|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
11167757|NCT01981967|EG000|Reported Event|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
11167758|NCT01981967|EG001|Reported Event|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
11167759|NCT01982123|BG000|Baseline|Diagnostic (99mTc-MAA and 99mTc-DTPA SPECT/CT)|"Patients undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT at baseline, mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment. Patients also undergo a pre-treatment 18F FDG PET/CT scan per standard of care.~Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT~Computed Tomography: Undergo 18F FDG PET/CT~Fludeoxyglucose F-18: Undergo 18F FDG PET/CT~Positron Emission Tomography: Undergo 18F FDG PET/CT~Single Photon Emission Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT~Technetium Tc-99m Albumin Aggregated: Undergo 99mTc-MAA SPECT/CT~Technetium Tc-99m DTPA: Undergo 99mTc-DTPA SPECT/CT"
11167760|NCT01982123|FG000|Participant Flow|Diagnostic (99mTc-MAA and 99mTc-DTPA SPECT/CT)|"Patients undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT at baseline, mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment. Patients also undergo a pre-treatment 18F FDG PET/CT scan per standard of care.~Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT~Computed Tomography: Undergo 18F FDG PET/CT~Fludeoxyglucose F-18: Undergo 18F FDG PET/CT~Positron Emission Tomography: Undergo 18F FDG PET/CT~Single Photon Emission Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT~Technetium Tc-99m Albumin Aggregated: Undergo 99mTc-MAA SPECT/CT~Technetium Tc-99m DTPA: Undergo 99mTc-DTPA SPECT/CT"
11167761|NCT01982123|OG000|Outcome|SPECT/CT Mid-& Post-RT|"Investigational 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment.~SPECT/CT: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation~Single Photon Emission Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT~Technetium Tc-99m Albumin Aggregated: Undergo 99mTc-MAA SPECT/CT~Technetium Tc-99m DTPA: Undergo 99mTc-DTPA SPECT/CT"
11231224|NCT02412098|OG002|Outcome|Normal Hepatic Function (Matched Control for Cohort 1)|Normal hepatic function (matched control for Cohort 1) included participants that served as controls for participants with moderate hepatic impairment.
11167762|NCT01982123|EG000|Reported Event|Diagnostic (99mTc-MAA and 99mTc-DTPA SPECT/CT)|"Patients undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT at baseline, mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment. Patients also undergo a pre-treatment 18F FDG PET/CT scan per standard of care.~Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT~Computed Tomography: Undergo 18F FDG PET/CT~Fludeoxyglucose F-18: Undergo 18F FDG PET/CT~Positron Emission Tomography: Undergo 18F FDG PET/CT~Single Photon Emission Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT~Technetium Tc-99m Albumin Aggregated: Undergo 99mTc-MAA SPECT/CT~Technetium Tc-99m DTPA: Undergo 99mTc-DTPA SPECT/CT"
11167763|NCT01982240|BG000|Baseline|Placebo|Matching placebo tablets QD for 12 weeks
11167764|NCT01982240|BG001|Baseline|Plecanatide 3.0 mg|Plecanatide tablets 3.0 mg QD for 12 weeks
11167765|NCT01982240|BG002|Baseline|Plecanatide 6.0 mg|Plecanatide tablets 6.0 mg QD for 12 weeks
11167766|NCT01982240|BG003|Baseline|Total|Total of all reporting groups
11167767|NCT01982240|FG000|Participant Flow|Placebo|"Matching placebo tablets QD for 12 weeks~Placebo: Matching placebo tablets QD for 12 weeks"
11167768|NCT01982240|FG001|Participant Flow|Plecanatide 3.0 mg|"Plecanatide tablets 3.0 mg QD for 12 weeks~Plecanatide: Plecanatide tablets QD for 12 weeks"
11167769|NCT01982240|FG002|Participant Flow|Plecanatide 6 mg|Plecanatide tablets 6.0 mg QD for 12 weeks
11167770|NCT01982240|OG000|Outcome|Placebo|"Matching placebo tablets QD for 12 weeks~Placebo: Matching placebo tablets QD for 12 weeks"
11167771|NCT01982240|OG001|Outcome|Plecanatide 3.0 mg|"Plecanatide tablets 3.0 mg QD for 12 weeks~Plecanatide: Plecanatide tablets QD for 12 weeks"
11167772|NCT01982240|OG002|Outcome|Plecanatide 6.0 mg|Plecanatide tablets 6.0 mg QD for 12 weeks
11167773|NCT01982240|OG000|Outcome|Placebo|Matching placebo tablets QD for 12 weeks
11167774|NCT01982240|OG001|Outcome|Plecanatide 3.0 mg|Plecanatide tablets 3.0 mg QD for 12 weeks
11167775|NCT01982240|OG000|Outcome|Plecanatide 3.0 mg|"Plecanatide tablets 3.0 mg QD for 12 weeks~Plecanatide: Plecanatide tablets QD for 12 weeks"
11167776|NCT01982240|OG001|Outcome|Placebo|"Matching placebo tablets QD for 12 weeks~Placebo: Matching placebo tablets QD for 12 weeks"
11167777|NCT01982240|EG000|Reported Event|Placebo|Matching placebo tablets QD for 12 weeks
11167778|NCT01982240|EG001|Reported Event|Plecanatide 3.0 mg|Plecanatide tablets 3.0 mg QD for 12 weeks
11167779|NCT01982240|EG002|Reported Event|Plecanatide 6.0 mg|Plecanatide tablets 3.0 mg QD for 12 weeks
11167780|NCT01982292|BG000|Baseline|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
11167781|NCT01982292|BG001|Baseline|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
11167782|NCT01982292|BG002|Baseline|Total|Total of all reporting groups
11167783|NCT01982292|FG000|Participant Flow|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
11167784|NCT01982292|FG001|Participant Flow|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
11167785|NCT01982292|OG000|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
11167786|NCT01982292|OG001|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
11167787|NCT01982292|EG000|Reported Event|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
11167788|NCT01982292|EG001|Reported Event|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
11167789|NCT01982331|BG000|Baseline|LAIV H2N2 Vaccine|"LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart~LAIV H2N2: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28"
11167790|NCT01982331|BG001|Baseline|Placebo|"Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally.~Placebo: placebo delivered intranasally. .25cc to each nostril at day 0 and day 28"
11167791|NCT01982331|BG002|Baseline|Total|Total of all reporting groups
11167792|NCT01982331|FG000|Participant Flow|LAIV H2N2 Vaccine|"LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart~LAIV H2N2: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28"
11167793|NCT01982331|FG001|Participant Flow|Placebo|"Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally.~Placebo: placebo delivered intranasally. .25cc to each nostril at day 0 and day 28"
11167794|NCT01982331|OG000|Outcome|LAIV H2N2 Vaccine|"LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart~LAIV H2N2: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28"
11167795|NCT01982331|OG001|Outcome|Placebo|"Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally.~Placebo: placebo delivered intranasally. .25cc to each nostril at day 0 and day 28"
11167796|NCT01982331|EG000|Reported Event|LAIV H2N2 Vaccine|"LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart~LAIV H2N2: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28"
11167797|NCT01982331|EG001|Reported Event|Placebo|"Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally.~Placebo: placebo delivered intranasally. .25cc to each nostril at day 0 and day 28"
11167798|NCT01982435|BG000|Baseline|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
11167799|NCT01982435|BG001|Baseline|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
11167800|NCT01982435|BG002|Baseline|Total|Total of all reporting groups
11167801|NCT01982435|FG000|Participant Flow|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
11167802|NCT01982435|FG001|Participant Flow|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
11167803|NCT01982435|OG000|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
11167804|NCT01982435|OG001|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
11167805|NCT01982435|EG000|Reported Event|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
11167806|NCT01982435|EG001|Reported Event|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
11167807|NCT01982539|BG000|Baseline|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
11167808|NCT01982539|FG000|Participant Flow|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
11167809|NCT01982539|OG000|Outcome|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
11167810|NCT01982539|EG000|Reported Event|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
11167811|NCT01982643|BG000|Baseline|Naltrexone Plus Bupropion|"extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)~naltrexone plus bupropion: Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks."
11167812|NCT01982643|FG000|Participant Flow|Naltrexone Plus Bupropion|"extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)~naltrexone plus bupropion: Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks."
11167813|NCT01982643|OG000|Outcome|Naltrexone Plus Bupropion|"extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)~naltrexone plus bupropion: Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks."
11231225|NCT02412098|OG003|Outcome|Normal Hepatic Function (Matched Control for Cohort 3)|Normal hepatic function (matched control for Cohort 3) included participants that served as controls for participants with mild hepatic impairment.
11231226|NCT02412098|OG000|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11167814|NCT01982643|EG000|Reported Event|Naltrexone Plus Bupropion|"extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)~naltrexone plus bupropion: Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks."
11167815|NCT01982682|BG000|Baseline|Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)|"CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.~Total-Body Irradiation (TBI): Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT~Mycophenolate mofetil: Given IV"
11167816|NCT01982682|FG000|Participant Flow|Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)|"CONDITIONING REGIMEN: Patients undergo TBI BID (bis in die/ twice a day) on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo cluster of differentiation 34+ (CD34+) selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.~Total-Body Irradiation (TBI): Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT~Mycophenolate mofetil: Given IV"
11167817|NCT01982682|OG000|Outcome|Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)|"CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.~Total-Body Irradiation (TBI): Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT~Mycophenolate mofetil: Given IV"
11167818|NCT01982682|OG000|Outcome|Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)|"CONDITIONING REGIMEN: Patients undergo TBI BID (bis in die/ twice a day) on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo cluster of differentiation 34+ (CD34+) selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.~Total-Body Irradiation (TBI): Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT~Mycophenolate mofetil: Given IV"
11167819|NCT01982682|EG000|Reported Event|Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)|"CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.~Total-Body Irradiation (TBI): Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT~Mycophenolate mofetil: Given IV"
11167820|NCT01982695|BG000|Baseline|Lisinopril|Lisinopril
11167821|NCT01982695|BG001|Baseline|Lospartan|Lisinopril
11167822|NCT01982695|BG002|Baseline|Total|Total of all reporting groups
11167823|NCT01982695|FG000|Participant Flow|Lisinopril|Approximately 0.07 mg/kg/day in oral capsules
11167824|NCT01982695|FG001|Participant Flow|Losartan|Approximately 0.7 mg/kg/day in oral capsules
11167825|NCT01982695|OG000|Outcome|Lisinopril|Lisinopril
11167826|NCT01982695|OG001|Outcome|Losartan|Losartan
11167827|NCT01982695|EG000|Reported Event|Lisinopril|Lisinopril
11167828|NCT01982695|EG001|Reported Event|Losartan|Losartan
11167829|NCT01982773|BG000|Baseline|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
11167830|NCT01982773|BG001|Baseline|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
11167831|NCT01982773|BG002|Baseline|Total|Total of all reporting groups
11167832|NCT01982773|FG000|Participant Flow|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
11167833|NCT01982773|FG001|Participant Flow|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
11167834|NCT01982773|OG000|Outcome|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
11167835|NCT01982773|OG001|Outcome|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
11167836|NCT01982773|EG000|Reported Event|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
11167837|NCT01982773|EG001|Reported Event|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
11167838|NCT01982786|BG000|Baseline|Arm 1|"IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions~Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost"
11231227|NCT02412098|OG001|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11353205|NCT03903822|EG007|Reported Event|PF-06700841 1.0% Cream BID|Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
11353206|NCT03905096|BG000|Baseline|Trial Part 1: BI 425809 / Donepezil + BI 425809|All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 (Treatment A, Reference 1) and on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg once a day (qd) (1 tablet) on day 1 to 7 of visit 3 and 10 mg qd (2 tablets) on day 8 to 28 of visit 3 (Treatment B, Test 1) in the fasted state with about 240 milliliters (ml) of fluid.
11353207|NCT03905096|BG001|Baseline|Trial Part 2: Donepezil / BI 425809 + Donepezil|All participants were orally administered a single dose of donepezil, 10 mg film-coated tablet on day 1 of visit 2 (Treatment C, Reference 2) and on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd (1 tablet) on day 1 to 24 of visit 3 (Treatment D, Test 2) in the fasted state with about 240 milliliters (ml) of fluid.
11353208|NCT03905096|BG002|Baseline|Total|Total of all reporting groups
11353209|NCT03905096|FG000|Participant Flow|Trial Part 1: BI 425809 / Donepezil + BI 425809|All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 (Treatment A, Reference 1) and on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg once a day (qd) (1 tablet) on day 1 to 7 of visit 3 and 10 mg qd (2 tablets) on day 8 to 28 of visit 3 (Treatment B, Test 1) in the fasted state with about 240 milliliters (ml) of fluid.
11353210|NCT03905096|FG001|Participant Flow|Trial Part 2: Donepezil / BI 425809 + Donepezil|All participants were orally administered a single dose of donepezil, 10 mg film-coated tablet on day 1 of visit 2 (Treatment C, Reference 2) and on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd (1 tablet) on day 1 to 24 of visit 3 (Treatment D, Test 2) in the fasted state with about 240 milliliters (ml) of fluid.
11353211|NCT03905096|OG000|Outcome|BI 425809 Alone Group (Part 1: Treatment A, Reference 1)|All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment A, Reference 1).
11353212|NCT03905096|OG001|Outcome|BI 425809 + Don Group (Part 1: Treatment B, Test 1)|All participants were orally administered a single dose of BI 425809, 25 mg, film-coated tablet, on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) once a day (qd) on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1).
11353213|NCT03905096|OG000|Outcome|Don Alone Group (Part 2: Treatment C, Reference 2)|All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
11353214|NCT03905096|OG001|Outcome|Don + BI 425809 Group (Part 2: Treatment D, Test 2)|All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
11353215|NCT03905096|OG001|Outcome|BI 425809 + Don Group (Part 1: Treatment B, Test 1)|All participants were orally administered a single dose of BI 425809, 25 mg, film-coated tablet, on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) qd on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1).
11353216|NCT03905096|EG000|Reported Event|BI 425809 Alone Group (Part 1: Treatment A, Reference 1)|All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment A, Reference 1).
11353217|NCT03905096|EG001|Reported Event|Donepezil Group (Part 1: Treatment B, Test 1)|All participants were orally administered multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) qd on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1).
11353218|NCT03905096|EG002|Reported Event|BI 425809 + Donepezil Group (Part 1: Treatment B, Test 1)|All participants were orally administered a single dose of BI 425809, 25 mg, film-coated tablet, on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) qd on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1).
11353219|NCT03905096|EG003|Reported Event|Donepezil Alone Group (Part 2: Treatment C, Reference 2)|All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
11353220|NCT03905096|EG004|Reported Event|BI 425809 Group (Part 2: Treatment D, Test 2)|All participants were orally administered multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
11353221|NCT03905096|EG005|Reported Event|Donepezil + BI 425809 Group (Part 2: Treatment D, Test 2)|All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
11353222|NCT03899064|BG000|Baseline|Test Sites|"5 test sites on the subject's back defined as:~Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation~Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation~Applications with MC2-01 vehicle, followed by irradiation~Applications with MC2-01 vehicle, no irradiation~No application, but irradiation"
11089472|NCT01523834|EG000|Reported Event|Panobinosat|"The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later.~Treatment:~Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy).~Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modification of drug administration from 3 times every week (QW) to 3 times every other week (QOW). Levels lower than 30 mg 3 times QOW is not permitted."
11089473|NCT01523873|BG000|Baseline|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
11231228|NCT02412098|OG002|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231229|NCT02412098|EG000|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231230|NCT02412098|EG001|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231231|NCT02412098|EG002|Reported Event|Normal Hepatic Function|Participants with normal hepatic function received a single dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1.
11231232|NCT02412111|BG000|Baseline|VX-661 + Ivacaftor (Active Comparator Period)|VX-661 100 mg and ivacaftor 150 mg fixed-dose combination tablet orally once daily in the morning and ivacaftor 150 mg tablet orally once daily in the evening for 8 weeks.
11231233|NCT02412111|BG001|Baseline|Ivacaftor Monotherapy (Active Comparator Period)|Ivacaftor 150 mg tablet orally every 12 hours as monotherapy for 8 weeks.
11231234|NCT02412111|BG002|Baseline|Total|Total of all reporting groups
11231235|NCT02412111|FG000|Participant Flow|Ivacaftor (Run-in Period)|Ivacaftor 150 milligram (mg) tablet orally every 12 hours for 4 weeks.
11231236|NCT02412111|FG001|Participant Flow|VX-661 + Ivacaftor (Active Comparator Period)|VX-661 100 mg and ivacaftor 150 mg fixed-dose combination tablet orally once daily in the morning and ivacaftor 150 mg tablet orally once daily in the evening for 8 weeks.
11231237|NCT02412111|FG002|Participant Flow|Ivacaftor Monotherapy (Active Comparator Period)|Ivacaftor 150 mg tablet orally every 12 hours as monotherapy for 8 weeks.
11231238|NCT02412111|OG000|Outcome|VX-661 + Ivacaftor (Active Comparator Period)|VX-661 100 mg and ivacaftor 150 mg fixed-dose combination tablet orally once daily in the morning and ivacaftor 150 mg tablet orally once daily in the evening for 8 weeks.
11231239|NCT02412111|OG001|Outcome|Ivacaftor Monotherapy (Active Comparator Period)|Ivacaftor 150 mg tablet orally every 12 hours as monotherapy for 8 weeks.
11089474|NCT01523873|FG000|Participant Flow|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
11231240|NCT02412111|OG000|Outcome|Ivacaftor (Run-in Period)|Ivacaftor 150 milligram (mg) tablet orally every 12 hours for 4 weeks.
11089475|NCT01523873|OG000|Outcome|Safety Population|Safety Population included All Included Patients administered with Dotarem.
11231241|NCT02412111|OG001|Outcome|VX-661 + Ivacaftor (Active Comparator Period)|VX-661 100 mg and ivacaftor 150 mg fixed-dose combination tablet orally once daily in the morning and ivacaftor 150 mg tablet orally once daily in the evening for 8 weeks.
11231242|NCT02412111|OG002|Outcome|Ivacaftor Monotherapy (Active Comparator Period)|Ivacaftor 150 mg tablet orally every 12 hours as monotherapy for 8 weeks.
11231243|NCT02412111|EG000|Reported Event|Ivacaftor (Run-in Period)|Ivacaftor 150 milligram (mg) tablet orally every 12 hours for 4 weeks.
11231244|NCT02412111|EG001|Reported Event|VX-661 + Ivacaftor (Active Comparator Period)|VX-661 100 mg and ivacaftor 150 mg fixed-dose combination tablet orally once daily in the morning and ivacaftor 150 mg tablet orally once daily in the evening for 8 weeks.
11231245|NCT02412111|EG002|Reported Event|Ivacaftor Monotherapy (Active Comparator Period)|Ivacaftor 150 mg tablet orally every 12 hours as monotherapy for 8 weeks.
11231246|NCT02412228|BG000|Baseline|Ixazomib Regimen|"Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18~Maintenance:~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years~Ixazomib: Cycle 1:~Ixazomib: 4mg/day 1, 8, 15~Cycles 2-6:~Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,~Maintenance:~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years~Cyclophosphamide: Cycle 1:~Cyclophosphamide: 50 mg/day continuous daily~Cycles 2-6:~Cyclophosphamide: 50 mg/day continuous daily~Dexamethasone: Cycle 1:~Dexamethasone: 20 mg/day 1, 8, 15~Cycles 2-6:~Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18"
11231247|NCT02412228|FG000|Participant Flow|Ixazomib Regimen|"Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18~Maintenance:~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years~Ixazomib: Cycle 1:~Ixazomib: 4mg/day 1, 8, 15~Cycles 2-6:~Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,~Maintenance:~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years~Cyclophosphamide: Cycle 1:~Cyclophosphamide: 50 mg/day continuous daily~Cycles 2-6:~Cyclophosphamide: 50 mg/day continuous daily~Dexamethasone: Cycle 1:~Dexamethasone: 20 mg/day 1, 8, 15~Cycles 2-6:~Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18"
11231248|NCT02412228|OG000|Outcome|Ixazomib Regimen|"Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18~Maintenance:~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years~Ixazomib: Cycle 1:~Ixazomib: 4mg/day 1, 8, 15~Cycles 2-6:~Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,~Maintenance:~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years~Cyclophosphamide: Cycle 1:~Cyclophosphamide: 50 mg/day continuous daily~Cycles 2-6:~Cyclophosphamide: 50 mg/day continuous daily~Dexamethasone: Cycle 1:~Dexamethasone: 20 mg/day 1, 8, 15~Cycles 2-6:~Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18"
11167839|NCT01982786|BG001|Baseline|Arm 2|"IGRT 37.5 Gy in 15 fractions~+ HDR brachytherapy boost 15 Gy~Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost~Brachytherapy: Brachytherapy boost"
11167840|NCT01982786|BG002|Baseline|Total|Total of all reporting groups
11167841|NCT01982786|FG000|Participant Flow|Arm 1|"IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions~Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost"
11167842|NCT01982786|FG001|Participant Flow|Arm 2|"IGRT 37.5 Gy in 15 fractions~+ HDR brachytherapy boost 15 Gy~Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost~Brachytherapy: Brachytherapy boost"
11167843|NCT01982786|OG000|Outcome|Arm 1|"IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions~Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost"
11167844|NCT01982786|OG001|Outcome|Arm 2|"IGRT 37.5 Gy in 15 fractions~+ HDR brachytherapy boost 15 Gy~Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost~Brachytherapy: Brachytherapy boost"
11167845|NCT01982786|EG000|Reported Event|Arm 1|"IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions~Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost"
11167846|NCT01982786|EG001|Reported Event|Arm 2|"IGRT 37.5 Gy in 15 fractions~+ HDR brachytherapy boost 15 Gy~Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost~Brachytherapy: Brachytherapy boost"
11167847|NCT01982812|BG000|Baseline|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
11167848|NCT01982812|BG001|Baseline|Standard AED|"Standard AED regimen~Standard AED: Active comparitor, Standard AED"
11167849|NCT01982812|BG002|Baseline|Total|Total of all reporting groups
11167850|NCT01982812|FG000|Participant Flow|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
11167851|NCT01982812|FG001|Participant Flow|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
11167852|NCT01982812|OG000|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
11167853|NCT01982812|OG001|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
11167854|NCT01982812|EG000|Reported Event|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
11167855|NCT01982812|EG001|Reported Event|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
11167856|NCT01982942|BG000|Baseline|Ibudilast|"Subjects will receive up to 100 mg/d ibudilast for 96 weeks.~ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks."
11167857|NCT01982942|BG001|Baseline|Placebo Oral Capsule|"Subjects will receive placebo for 96 weeks.~Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks."
11167858|NCT01982942|BG002|Baseline|Total|Total of all reporting groups
11167859|NCT01982942|FG000|Participant Flow|Ibudilast|"Subjects will receive up to 100 mg/d ibudilast for 96 weeks.~ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks."
11167860|NCT01982942|FG001|Participant Flow|Placebo Oral Capsule|"Subjects will receive placebo for 96 weeks.~Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks."
11167861|NCT01982942|OG000|Outcome|Ibudilast|"Subjects will receive up to 100 mg/d ibudilast for 96 weeks.~ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks."
11167862|NCT01982942|OG001|Outcome|Placebo Oral Capsule|"Subjects will receive placebo for 96 weeks.~Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks."
11167863|NCT01982942|EG000|Reported Event|Ibudilast|"Subjects will receive up to 100 mg/d ibudilast for 96 weeks.~ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks."
11167864|NCT01982942|EG001|Reported Event|Placebo Oral Capsule|"Subjects will receive placebo for 96 weeks.~Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks."
11167865|NCT01982955|BG000|Baseline|Phase 1b: Tepotinib (300 mg)|Participants received Tepotinib 300 milligram (mg) along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167866|NCT01982955|BG001|Baseline|Phase 1b: Tepotinib (500 mg)|Participants received Tepotinib 500 milligram (mg) along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167867|NCT01982955|BG002|Baseline|Phase 2: Tepotinib and Gefitinib|Participants randomized to receive Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11231249|NCT02412228|EG000|Reported Event|Ixazomib Regimen|"Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18~Maintenance:~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years~Ixazomib: Cycle 1:~Ixazomib: 4mg/day 1, 8, 15~Cycles 2-6:~Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,~Maintenance:~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years~Cyclophosphamide: Cycle 1:~Cyclophosphamide: 50 mg/day continuous daily~Cycles 2-6:~Cyclophosphamide: 50 mg/day continuous daily~Dexamethasone: Cycle 1:~Dexamethasone: 20 mg/day 1, 8, 15~Cycles 2-6:~Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18"
11231250|NCT02412306|BG000|Baseline|Phase 1b: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from week 2 and all cycles thereafter.
11231251|NCT02412306|BG001|Baseline|Phase 1b: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231252|NCT02412306|BG002|Baseline|Phase 2: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from Week 2 and all cycles thereafter.
11231253|NCT02412306|BG003|Baseline|Expansion Cohort: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from Week 2 and all cycles thereafter.
11231254|NCT02412306|BG004|Baseline|Expansion Cohort: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231255|NCT02412306|BG005|Baseline|Total|Total of all reporting groups
11231256|NCT02412306|FG000|Participant Flow|Phase 1b: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from week 2 and all cycles thereafter.
11231257|NCT02412306|FG001|Participant Flow|Phase 1b: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231258|NCT02412306|FG002|Participant Flow|Phase 2: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from Week 2 and all cycles thereafter.
11231259|NCT02412306|FG003|Participant Flow|Expansion Cohort: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from Week 2 and all cycles thereafter.
11231260|NCT02412306|FG004|Participant Flow|Expansion Cohort: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231261|NCT02412306|OG000|Outcome|Phase 1b: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from week 2 and all cycles thereafter.
11231262|NCT02412306|OG001|Outcome|Phase 1b: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231263|NCT02412306|OG000|Outcome|Phase 2: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from Week 2 and all cycles thereafter.
10887922|NCT00503867|EG000|Reported Event|SIR-Spheres Microspheres|Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.
11231264|NCT02412306|OG000|Outcome|Phase 1b: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231265|NCT02412306|OG002|Outcome|Phase 2: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from Week 2 and all cycles thereafter.
11231266|NCT02412306|OG000|Outcome|Blinatumomab 9/28 μg/Day (Phase 1b and Phase 2 Adults)|Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from week 2 and all cycles thereafter.
11231267|NCT02412306|OG001|Outcome|Blinatumomab 5/15 µg/m²/Day (Phase 1b and Phase 2 Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231268|NCT02412306|OG002|Outcome|Blinatumomab 9/28 μg/Day (Phase 1b Only Adults)|Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from week 2 and all cycles thereafter.
11231269|NCT02412306|OG003|Outcome|Blinatumomab 5/15 µg/m²/Day (Phase 1b Only Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231270|NCT02412306|OG000|Outcome|Phase 1b and Phase 2: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from week 2 and all cycles thereafter.
11231271|NCT02412306|OG001|Outcome|Phase 1b and Phase 2: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231272|NCT02412306|OG000|Outcome|Expansion Cohort: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from week 2 and all cycles thereafter.
11231273|NCT02412306|OG001|Outcome|Expansion Cohort: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231274|NCT02412306|OG000|Outcome|Expansion Cohort: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231275|NCT02412306|EG000|Reported Event|Phase 1b: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from week 2 and all cycles thereafter.
11231276|NCT02412306|EG001|Reported Event|Phase 1b: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by CIV over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231277|NCT02412306|EG002|Reported Event|Phase 2: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from Week 2 and all cycles thereafter.
11231278|NCT02412306|EG003|Reported Event|Expansion Cohort: Blinatumomab 9/28 μg/Day (Adults)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first week of cycle 1, escalated to 28 μg/day starting from Week 2 and all cycles thereafter.
11231279|NCT02412306|EG004|Reported Event|Expansion Cohort: Blinatumomab 5/15 µg/m²/Day (Pediatric)|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.
11231280|NCT02412371|BG000|Baseline|Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231281|NCT02412371|BG001|Baseline|Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231282|NCT02412371|BG002|Baseline|Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231283|NCT02412371|BG003|Baseline|Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231284|NCT02412371|BG004|Baseline|Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11089476|NCT01523873|OG000|Outcome|Patients With Moderate to Severe Impaired Renal Function|Patients identified with moderate to severe impaired renal function at the time of inclusion (i.e. estimated Glomerular Filtration Rate (eGFR) or estimated creatinine clearance (eCrCl) <60 ml/min (1.73 m2))
11089477|NCT01523873|OG000|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
11089478|NCT01523873|EG000|Reported Event|Safety Population|Safety Population included All Included Patients administered with Dotarem.
11089479|NCT01523886|BG000|Baseline|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
11089480|NCT01523886|BG001|Baseline|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
11089481|NCT01523886|BG002|Baseline|Total|Total of all reporting groups
11089482|NCT01523886|FG000|Participant Flow|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
11089483|NCT01523886|FG001|Participant Flow|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
11089484|NCT01523886|OG000|Outcome|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
11089485|NCT01523886|OG001|Outcome|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
11089486|NCT01523886|EG000|Reported Event|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
11089487|NCT01523886|EG001|Reported Event|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
11089488|NCT01523899|BG000|Baseline|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
11089489|NCT01523899|BG001|Baseline|Standard Culture|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
11089490|NCT01523899|BG002|Baseline|Total|Total of all reporting groups
11089491|NCT01523899|FG000|Participant Flow|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
11089492|NCT01523899|FG001|Participant Flow|Standard Culture|Standard bacterial culture and susceptibility testing
11089493|NCT01523899|OG000|Outcome|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
11089494|NCT01523899|OG001|Outcome|Standard Culture|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
11089495|NCT01523899|OG001|Outcome|Standard Culture|Standard bacterial culture and susceptibility testing
11089496|NCT01523899|EG000|Reported Event|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
11089497|NCT01523899|EG001|Reported Event|Standard Culture|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
11089498|NCT01523964|BG000|Baseline|DMD Subject Ages 3-7 Inclusive|
11089499|NCT01523964|BG001|Baseline|DMD Subject Ages 8-12 Inclusive|
11089500|NCT01523964|BG002|Baseline|Healthy Control Ages 3-7 Inclusive|
11089501|NCT01523964|BG003|Baseline|Healthy Control Ages 8-12 Inclusive|
11089502|NCT01523964|BG004|Baseline|Total|Total of all reporting groups
11089503|NCT01523964|FG000|Participant Flow|DMD Subject Ages 3-7 Inclusive|
11089504|NCT01523964|FG001|Participant Flow|DMD Subject Ages 8-12 Inclusive|
11089505|NCT01523964|FG002|Participant Flow|Healthy Control Ages 3-7 Inclusive|
11089506|NCT01523964|FG003|Participant Flow|Healthy Control Ages 8-12 Inclusive|
11089507|NCT01523964|OG000|Outcome|DMD Subject Ages 3-7 Inclusive|
11089508|NCT01523964|OG001|Outcome|DMD Subject Ages 8-12 Inclusive|
11089509|NCT01523964|OG002|Outcome|Healthy Control Ages 3-7 Inclusive|
11089510|NCT01523964|OG003|Outcome|Healthy Control Ages 8-12 Inclusive|
11089511|NCT01523964|EG000|Reported Event|DMD Subject Ages 3-7 Inclusive|
11089512|NCT01523964|EG001|Reported Event|DMD Subject Ages 8-12 Inclusive|
11089513|NCT01523964|EG002|Reported Event|Healthy Control Ages 3-7 Inclusive|
11089514|NCT01523964|EG003|Reported Event|Healthy Control Ages 8-12 Inclusive|
11089515|NCT01524133|BG000|Baseline|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
11089516|NCT01524133|BG001|Baseline|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
11089517|NCT01524133|BG002|Baseline|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
11089518|NCT01524133|BG003|Baseline|Total|Total of all reporting groups
11089519|NCT01524133|FG000|Participant Flow|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
11089520|NCT01524133|FG001|Participant Flow|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
11089521|NCT01524133|FG002|Participant Flow|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
11089522|NCT01524133|OG000|Outcome|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
11089523|NCT01524133|OG001|Outcome|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
11089524|NCT01524133|OG002|Outcome|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
11089525|NCT01524133|EG000|Reported Event|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
11089526|NCT01524133|EG001|Reported Event|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
11089527|NCT01524133|EG002|Reported Event|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
11089528|NCT01524198|BG000|Baseline|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
11089529|NCT01524198|BG001|Baseline|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
11089530|NCT01524198|BG002|Baseline|Total|Total of all reporting groups
11089531|NCT01524198|FG000|Participant Flow|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
11089532|NCT01524198|FG001|Participant Flow|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
11089533|NCT01524198|OG000|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
11089534|NCT01524198|OG001|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
11089535|NCT01524198|EG000|Reported Event|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
11089536|NCT01524198|EG001|Reported Event|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
11089537|NCT01524224|BG000|Baseline|2 mg LY2495655|2 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089538|NCT01524224|BG001|Baseline|7 mg LY2495655|7 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089539|NCT01524224|BG002|Baseline|21 mg LY2495655|21 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089540|NCT01524224|BG003|Baseline|70 mg LY2495655|70 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089541|NCT01524224|BG004|Baseline|100 mg LY2495655|100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
11089542|NCT01524224|BG005|Baseline|210 mg LY2495655|210 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089543|NCT01524224|BG006|Baseline|300 mg LY2495655|300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
11089544|NCT01524224|BG007|Baseline|700 mg LY2495655|700 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089545|NCT01524224|BG008|Baseline|Total|Total of all reporting groups
11089546|NCT01524224|FG000|Participant Flow|2 mg LY2495655|2 milligrams (mg) LY2495655 2 milligrams (mg) every 2 weeks. Dose Escalation Phase
11089547|NCT01524224|FG001|Participant Flow|7 mg LY2495655|7 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089548|NCT01524224|FG002|Participant Flow|21 mg LY2495655|21 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089549|NCT01524224|FG003|Participant Flow|70 mg LY2495655|70 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089550|NCT01524224|FG004|Participant Flow|100 mg LY2495655|100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
11089551|NCT01524224|FG005|Participant Flow|210 mg LY2495655|210 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089552|NCT01524224|FG006|Participant Flow|300 mg LY2495655|300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
11089553|NCT01524224|FG007|Participant Flow|700 mg LY2495655|700 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089554|NCT01524224|OG000|Outcome|2 mg LY2495655|2 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089555|NCT01524224|OG001|Outcome|7 mg LY2495655|7 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089556|NCT01524224|OG002|Outcome|21 mg LY2495655|21 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089557|NCT01524224|OG003|Outcome|70 mg LY2495655|70 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089558|NCT01524224|OG004|Outcome|100 mg LY2495655|100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
11089559|NCT01524224|OG005|Outcome|210 mg LY2495655|210 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089560|NCT01524224|OG006|Outcome|300 mg LY2495655|300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
11089561|NCT01524224|OG007|Outcome|700 mg LY2495655|700 mg LY2495655 every 2 weeks. Dose Escalation Phase
11089562|NCT01524224|EG000|Reported Event|2 mg LY2495655|2 mg LY2495655 every 2 weeks. Dose Escalation Phase.
11089563|NCT01524224|EG001|Reported Event|7 mg LY2495655|7 mg LY2495655 every 2 weeks. Dose Escalation Phase.
11089564|NCT01524224|EG002|Reported Event|21 mg LY2495655|21 mg LY2495655 every 2 weeks. Dose Escalation Phase.
10887923|NCT00503906|BG000|Baseline|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
11231285|NCT02412371|BG005|Baseline|Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT|"Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231286|NCT02412371|BG006|Baseline|Total|Total of all reporting groups
11231287|NCT02412371|FG000|Participant Flow|Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 60 mg veliparib twice daily (BID) in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy (RT) for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231288|NCT02412371|FG001|Participant Flow|Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231289|NCT02412371|FG002|Participant Flow|Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231290|NCT02412371|FG003|Participant Flow|Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231291|NCT02412371|FG004|Participant Flow|Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231292|NCT02412371|FG005|Participant Flow|Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT|"Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231293|NCT02412371|OG000|Outcome|Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231294|NCT02412371|OG001|Outcome|Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231295|NCT02412371|OG002|Outcome|Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
10887924|NCT00503906|FG000|Participant Flow|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
11089565|NCT01524224|EG003|Reported Event|70 mg LY2495655|70 mg LY2495655 every 2 weeks. Dose Escalation Phase.
11231296|NCT02412371|OG003|Outcome|Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231297|NCT02412371|OG004|Outcome|Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11089566|NCT01524224|EG004|Reported Event|100 mg LY2495655|100 mg LY2495655 every 2 weeks. Dose Confirmation Phase.
11089567|NCT01524224|EG005|Reported Event|210 mg LY2495655|210 mg LY2495655 every 2 weeks. Dose Escalation Phase.
11089568|NCT01524224|EG006|Reported Event|300 mg LY2495655|300 mg LY2495655 every 2 weeks. Dose Confirmation Phase.
11089569|NCT01524224|EG007|Reported Event|700 mg LY2495655|700 mg LY2495655 every 2 weeks. Dose Escalation Phase.
11089570|NCT01524289|BG000|Baseline|Anacetrapib 100 mg|Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.
11089571|NCT01524289|BG001|Baseline|Placebo|Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
11089572|NCT01524289|BG002|Baseline|Total|Total of all reporting groups
11089573|NCT01524289|FG000|Participant Flow|Anacetrapib 100 mg|Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.
11089574|NCT01524289|FG001|Participant Flow|Placebo|Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
11089575|NCT01524289|OG000|Outcome|Anacetrapib 100 mg|Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment phase.
11089576|NCT01524289|OG001|Outcome|Placebo|Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment phase.
11089577|NCT01524289|EG000|Reported Event|Anacetrapib 100 mg - Treatment Phase|Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks.
11089578|NCT01524289|EG001|Reported Event|Placebo - Treatment Phase|Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks.
11089579|NCT01524289|EG002|Reported Event|Anacetrapib 100 mg - Reversal Phase|Safety data that was reported during the 12-week period from the day after the treatment phase to the participant's last visit (discontinuation visit or week 64).
11089580|NCT01524289|EG003|Reported Event|Placebo - Reversal Phase|Safety data that was reported during the 12-week period from the day after the treatment phase to the participant's last visit (discontinuation visit or week 64).
11089581|NCT01524302|BG000|Baseline|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
11089582|NCT01524302|BG001|Baseline|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
11089583|NCT01524302|BG002|Baseline|Total|Total of all reporting groups
11089584|NCT01524302|FG000|Participant Flow|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
11089585|NCT01524302|FG001|Participant Flow|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
11089586|NCT01524302|OG000|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
11089587|NCT01524302|OG001|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
11089588|NCT01524302|OG000|Outcome|Log Inhibition of 0.5mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
11089589|NCT01524302|OG001|Outcome|Log Inhibition of 1.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
11089590|NCT01524302|OG002|Outcome|Log Inhibition of 2.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
11089591|NCT01524302|OG003|Outcome|Log Inhibition of 4.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
11089592|NCT01524302|EG000|Reported Event|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
11089593|NCT01524302|EG001|Reported Event|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
11089594|NCT01524627|BG000|Baseline|Placebo|"Participants will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
11089595|NCT01524627|BG001|Baseline|Varenicline|"Subjects will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
11089596|NCT01524627|BG002|Baseline|Total|Total of all reporting groups
11089597|NCT01524627|FG000|Participant Flow|Placebo|Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective as Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
11089598|NCT01524627|FG001|Participant Flow|Varenicline|Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
11089599|NCT01524627|OG000|Outcome|Placebo|"Participants will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
11089600|NCT01524627|OG001|Outcome|Varenicline|"Subjects will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
11089601|NCT01524627|EG000|Reported Event|Placebo|"Participants will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
11089602|NCT01524627|EG001|Reported Event|Varenicline|"Subjects will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
11089603|NCT01524679|BG000|Baseline|Treatment Group|"pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B~Pegylated interferon alfa-2a plus nucleos(t)ide(s): Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)"
11089604|NCT01524679|BG001|Baseline|Control Group|ongoing nucleos(t)ide based treatment alone
11089605|NCT01524679|BG002|Baseline|Total|Total of all reporting groups
11089606|NCT01524679|FG000|Participant Flow|Treatment Group|"pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B~Pegylated interferon alfa-2a plus nucleos(t)ide(s): Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)"
11089607|NCT01524679|FG001|Participant Flow|Control Group|ongoing nucleos(t)ide based treatment alone
11089608|NCT01524679|OG000|Outcome|Treatment Group|"pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B~Pegylated interferon alfa-2a plus nucleos(t)ide(s): Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)"
11089609|NCT01524679|OG001|Outcome|Control Group|ongoing nucleos(t)ide based treatment alone
11089610|NCT01524679|EG000|Reported Event|Treatment Group|"pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B~Pegylated interferon alfa-2a plus nucleos(t)ide(s): Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)"
11089611|NCT01524679|EG001|Reported Event|Control Group|ongoing nucleos(t)ide based treatment alone
11089612|NCT01524692|BG000|Baseline|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
11089613|NCT01524692|FG000|Participant Flow|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
11089614|NCT01524692|OG000|Outcome|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
11089615|NCT01524692|OG000|Outcome|Patients With Any Adverse Event|Patients with any adverse event as defined by CTCAE
11089616|NCT01524692|EG000|Reported Event|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
11089617|NCT01524770|BG000|Baseline|Entire Study Population|All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector.
11089618|NCT01524770|FG000|Participant Flow|Manual Syringe First, Then Auto-injector|"First Intervention:~Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.~There was a washout period of at least 28 days between treatment periods.~Second intervention:~Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector."
11089619|NCT01524770|FG001|Participant Flow|Auto-injector First, Then Manual Syringe|"First Intervention:~Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.~There was a washout period of at least 28 days between treatment periods.~Second intervention:~Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe."
11089620|NCT01524770|OG000|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
11089621|NCT01524770|OG001|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
11089622|NCT01524770|EG000|Reported Event|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period
11089623|NCT01524770|EG001|Reported Event|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
11089624|NCT01524783|BG000|Baseline|Everolimus + BSC|Participants received everolimus 10 mg once daily BSC throughout the study
11089625|NCT01524783|BG001|Baseline|Placebo+BSC|Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
11089626|NCT01524783|BG002|Baseline|Total|Total of all reporting groups
11089627|NCT01524783|FG000|Participant Flow|Everolimus + BSC (Throughout Study)|Participants received everolimus 10 mg once daily BSC throughout the study
11089628|NCT01524783|FG001|Participant Flow|Placebo+BSC (Blinded Period)|Participants received matching placebo once daily plus BSC during the blinded period
11089629|NCT01524783|FG002|Participant Flow|Everolimus+BSC (Crossover)|Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
11089630|NCT01524783|OG000|Outcome|Everolimus + BSC|Participants received everolimus 10 mg once daily BSC throughout the study
11167868|NCT01982955|BG003|Baseline|Phase 2: Pemetrexed and Cisplatin/Carboplatin|Participants randomized to receive 500 milligram per square meter (mg/m^2) of Pemetrexed as intravenous infusion over 10 minutes in combination with Cisplatin (75 mg/m2 as an intravenous infusion over 2 hours) or Carboplatin (intravenously at a dose of area under curve (AUC) 5 or AUC6 at the discretion of the Investigator) on Day 1 of each 21-day cycle until progressive disease, intolerable toxicity or withdrawal from treatment or up to 6 cycles if or 4 cycles followed by Premetrexed maintenance monotherapy.
11167869|NCT01982955|BG004|Baseline|Phase 2: Single-arm Cohort (MET+ T790M Positive)|Participants with MET+ T790M positive Non-small Cell Lung Cancer (NSCLC) received a Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167870|NCT01982955|BG005|Baseline|Total|Total of all reporting groups
11167871|NCT01982955|FG000|Participant Flow|Phase 1b: Tepotinib (300 mg)|Participants received Tepotinib 300 milligram (mg) along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167872|NCT01982955|FG001|Participant Flow|Phase 1b: Tepotinib (500 mg)|Participants received Tepotinib 500 milligram (mg) along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167873|NCT01982955|FG002|Participant Flow|Phase 2: Tepotinib and Gefitinib|Participants randomized to receive Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167874|NCT01982955|FG003|Participant Flow|Phase 2: Pemetrexed and Cisplatin/Carboplatin|Participants randomized to receive 500 milligram per square meter (mg/m^2) of Pemetrexed as intravenous infusion over 10 minutes in combination with Cisplatin (75 mg/m2 as an intravenous infusion over 2 hours) or Carboplatin (intravenously at a dose of area under curve (AUC) 5 or AUC6 at the discretion of the Investigator) on Day 1 of each 21-day cycle until progressive disease, intolerable toxicity or withdrawal from treatment or up to 6 cycles if or 4 cycles followed by Premetrexed maintenance monotherapy.
11167875|NCT01982955|FG004|Participant Flow|Phase 2: Single-arm Cohort (MET+ T790M Positive)|Participants with MET+ T790M positive Non-small Cell Lung Cancer (NSCLC) received a Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167876|NCT01982955|OG000|Outcome|Phase 1b: Tepotinib (300 mg)|Participants received Tepotinib 300 milligram (mg) along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167877|NCT01982955|OG001|Outcome|Phase 1b: Tepotinib (500 mg)|Participants received Tepotinib 500 milligram (mg) along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167878|NCT01982955|OG000|Outcome|Phase 2: Tepotinib and Gefitinib|Participants randomized to receive Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167879|NCT01982955|OG001|Outcome|Phase 2: Pemetrexed and Cisplatin/Carboplatin|Participants randomized to receive 500 milligram per square meter (mg/m^2) of Pemetrexed as intravenous infusion over 10 minutes in combination with Cisplatin (75 mg/m2 as an intravenous infusion over 2 hours) or Carboplatin (intravenously at a dose of area under curve (AUC) 5 or AUC6 at the discretion of the Investigator) on Day 1 of each 21-day cycle until progressive disease, intolerable toxicity or withdrawal from treatment or up to 6 cycles if or 4 cycles followed by Premetrexed maintenance monotherapy.
11167880|NCT01982955|OG002|Outcome|Phase 2: Single-arm Cohort (MET+ T790M Positive)|Participants with MET+ T790M positive Non-small Cell Lung Cancer (NSCLC) received a Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167881|NCT01982955|OG000|Outcome|Phase 2: Single-arm Cohort (MET+ T790M Positive)|Participants with MET+ T790M positive Non-small Cell Lung Cancer (NSCLC) received a Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167882|NCT01982955|EG000|Reported Event|Phase 1b: Tepotinib (300 mg)|Participants received Tepotinib 300 milligram (mg) along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167883|NCT01982955|EG001|Reported Event|Phase 1b: Tepotinib (500 mg)|Participants received Tepotinib 500 milligram (mg) along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167884|NCT01982955|EG002|Reported Event|Phase 2: Tepotinib and Gefitinib|Participants randomized to receive Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167885|NCT01982955|EG003|Reported Event|Phase 2: Pemetrexed and Cisplatin/Carboplatin|Participants randomized to receive 500 milligram per square meter (mg/m^2) of Pemetrexed as intravenous infusion over 10 minutes in combination with Cisplatin (75 mg/m2 as an intravenous infusion over 2 hours) or Carboplatin (intravenously at a dose of area under curve (AUC) 5 or AUC6 at the discretion of the Investigator) on Day 1 of each 21-day cycle until progressive disease, intolerable toxicity or withdrawal from treatment or up to 6 cycles if or 4 cycles followed by Premetrexed maintenance monotherapy.
11167886|NCT01982955|EG004|Reported Event|Phase 2: Single-arm Cohort (MET+ T790M Positive)|Participants with MET+ T790M positive Non-small Cell Lung Cancer (NSCLC) received a Tepotinib recommended Phase 2 dose 500 mg once daily along with 250 mg Gefitinib tablets orally once daily over a 21-day treatment cycle until progressive disease, intolerable toxicity or withdrawal from treatment.
11167887|NCT01982968|BG000|Baseline|Control|Subjects to receive standard anti-reflux treatment per clinical discretion
11167888|NCT01982968|BG001|Baseline|Surgery|"Subjects will receive laparoscopic fundoplication surgery~Surgery: Full fundoplication surgery for the treatment of abnormal GER"
11353223|NCT03899064|FG000|Participant Flow|Test Sites|"5 test sites on the subject's back defined as:~Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation~Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation~Applications with MC2-01 vehicle, followed by irradiation~Applications with MC2-01 vehicle, no irradiation~No application, but irradiation"
11089631|NCT01524783|OG001|Outcome|Placebo + BSC|Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
11167889|NCT01982968|BG002|Baseline|Total|Total of all reporting groups
11167890|NCT01982968|FG000|Participant Flow|Control|Subjects to receive standard anti-reflux treatment per clinical discretion
11089632|NCT01524783|OG000|Outcome|Everolimus + BSC (Throughout the Study)|Participants received everolimus 10 mg once daily BSC throughout the study
11089633|NCT01524783|OG001|Outcome|Everolimus +BSC (Crossover)|Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
11089634|NCT01524783|OG002|Outcome|Everolimus+BSC (All)|All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
11089635|NCT01524783|OG003|Outcome|Placebo + BSC (Blinded Period)|Participants received matching placebo once daily plus BSC during the blinded period
11089636|NCT01524783|EG000|Reported Event|Everolimus+BSC (Throughout Study)|Participants received everolimus 10 mg once daily plus BSC throughout the study
11089637|NCT01524783|EG001|Reported Event|Everolimus +BSC (Crossover)|Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
11089638|NCT01524783|EG002|Reported Event|Everolimus+BSC (All)|All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
11089639|NCT01524783|EG003|Reported Event|Placebo+BSC (Blinded Period)|Participants received matching placebo once daily plus best supportive care (BSC) during the blinded period.
11089640|NCT01524796|BG000|Baseline|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
11089641|NCT01524796|FG000|Participant Flow|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
11089642|NCT01524796|OG000|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
11089643|NCT01524796|EG000|Reported Event|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
11089644|NCT01524887|BG000|Baseline|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
11089645|NCT01524887|BG001|Baseline|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
11089646|NCT01524887|BG002|Baseline|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
11089647|NCT01524887|BG003|Baseline|Total|Total of all reporting groups
11089648|NCT01524887|FG000|Participant Flow|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
11089649|NCT01524887|FG001|Participant Flow|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
11089650|NCT01524887|FG002|Participant Flow|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
11089651|NCT01524887|OG000|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
11089652|NCT01524887|OG001|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
11089653|NCT01524887|OG002|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
11089654|NCT01524887|EG000|Reported Event|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
11089655|NCT01524887|EG001|Reported Event|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
11089656|NCT01524887|EG002|Reported Event|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
11089657|NCT01524900|BG000|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
11089658|NCT01524900|BG001|Baseline|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
11089659|NCT01524900|BG002|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
11089660|NCT01524900|BG003|Baseline|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
11089661|NCT01524900|BG004|Baseline|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
11089662|NCT01524900|BG005|Baseline|Total|Total of all reporting groups
11089663|NCT01524900|FG000|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
11089664|NCT01524900|FG001|Participant Flow|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
11089665|NCT01524900|FG002|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
11353224|NCT03899064|OG000|Outcome|Test Sites|"5 test sites on the subject's back defined as:~Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation~Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation~Applications with MC2-01 vehicle, followed by irradiation~Applications with MC2-01 vehicle, no irradiation~No application, but irradiation"
11353225|NCT03899064|EG000|Reported Event|Test Sites|"5 test sites on the subject's back defined as:~Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation~Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation~Applications with MC2-01 vehicle, followed by irradiation~Applications with MC2-01 vehicle, no irradiation~No application, but irradiation"
11353226|NCT03903159|BG000|Baseline|Treatment Group|"Positive Peer Journaling (PPJ)~Positive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing good and bad things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as recovery, work/school, spirituality, home and household, and health."
11353227|NCT03903159|FG000|Participant Flow|Treatment Group|"Positive Peer Journaling (PPJ)~Positive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing good and bad things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as recovery, work/school, spirituality, home and household, and health."
11353228|NCT03903159|OG000|Outcome|Treatment Group|"Positive Peer Journaling (PPJ)~Positive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing good and bad things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as recovery, work/school, spirituality, home and household, and health."
11353229|NCT03903159|EG000|Reported Event|Treatment Group|"Positive Peer Journaling (PPJ)~Positive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing good and bad things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as recovery, work/school, spirituality, home and household, and health."
11353230|NCT03902392|BG000|Baseline|NATUR-OX Group (A)|"Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm~NaturOx Group (A): Comparison between dietary supplement and placebo"
11353231|NCT03902392|BG001|Baseline|Placebo Group (B)|"Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)~Placebo Group (B): Comparison between dietary supplement and placebo"
11353232|NCT03902392|BG002|Baseline|Total|Total of all reporting groups
11353233|NCT03902392|FG000|Participant Flow|NATUR-OX Group (A)|"Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm~NaturOx Group (A): Comparison between dietary supplement and placebo"
11353234|NCT03902392|FG001|Participant Flow|Placebo Group (B)|"Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)~Placebo Group (B): Comparison between dietary supplement and placebo"
11353235|NCT03902392|OG000|Outcome|NATUR-OX Group (A)|"Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm~NaturOx Group (A): Comparison between dietary supplement and placebo"
11353236|NCT03902392|OG001|Outcome|Placebo Group (B)|"Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)~Placebo Group (B): Comparison between dietary supplement and placebo"
11089666|NCT01524900|FG003|Participant Flow|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
11089667|NCT01524900|FG004|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
11089668|NCT01524900|OG000|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
11089669|NCT01524900|OG001|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
11353237|NCT03902392|EG000|Reported Event|NATUR-OX Group (A)|"Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm~NaturOx Group (A): Comparison between dietary supplement and placebo"
11353238|NCT03902392|EG001|Reported Event|Placebo Group (B)|"Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)~Placebo Group (B): Comparison between dietary supplement and placebo"
11353239|NCT03901105|BG000|Baseline|All Scans|Mild AD and MCI due to AD from the flortaucipir PET scan arm
11353240|NCT03901105|FG000|Participant Flow|All Subjects|Mild AD and MCI due to AD from the flortaucipir PET scan arm
11353241|NCT03901105|OG000|Outcome|CMD (CDR-SB Change >=1)|Subjects who experienced at least a 1 point worsening in CDR-SB score over 18 months
11353242|NCT03901105|OG001|Outcome|No CMD|Subjects who experienced less than a 1 point worsening in CDR-SB score over 18 months
11353243|NCT03901105|OG000|Outcome|CMD Yes|Subjects who experienced CMD for the clinical measure as described above
11353244|NCT03901105|OG001|Outcome|No CMD|Subjects who did not experience CMD for the clinical measure as described above
11167891|NCT01982968|FG001|Participant Flow|Surgery|"Subjects will receive laparoscopic fundoplication surgery~Surgery: Full fundoplication surgery for the treatment of abnormal GER"
11167892|NCT01982968|OG000|Outcome|Control|Subjects to receive standard anti-reflux treatment per clinical discretion
11167893|NCT01982968|OG001|Outcome|Surgery|"Subjects will receive laparoscopic fundoplication surgery~Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)"
11167894|NCT01982968|EG000|Reported Event|Control|Subjects to receive standard anti-reflux treatment per clinical discretion
11167895|NCT01982968|EG001|Reported Event|Surgery|"Subjects will receive laparoscopic fundoplication surgery~Surgery: Full fundoplication surgery for the treatment of abnormal GER"
11167896|NCT01983020|BG000|Baseline|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
11167897|NCT01983020|BG001|Baseline|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
11167898|NCT01983020|BG002|Baseline|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
11167899|NCT01983020|BG003|Baseline|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
11167900|NCT01983020|BG004|Baseline|Total|Total of all reporting groups
11167901|NCT01983020|FG000|Participant Flow|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
11353245|NCT03901105|OG000|Outcome|τAD++ Scan Result|Subjects with a τAD++ scan result
11353246|NCT03901105|OG001|Outcome|Non-τAD++ Scan Result|Subjects with a Non-τAD++ scan result
11353247|NCT03901105|OG000|Outcome|All Subjects/All Readers|All subjects scans included in the study across 5 independent readers
11167902|NCT01983020|FG001|Participant Flow|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
11167903|NCT01983020|FG002|Participant Flow|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
11167904|NCT01983020|FG003|Participant Flow|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
11167905|NCT01983020|OG000|Outcome|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
11167906|NCT01983020|OG001|Outcome|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
11167907|NCT01983020|OG002|Outcome|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
11167908|NCT01983020|OG003|Outcome|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
11167909|NCT01983020|EG000|Reported Event|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
11353248|NCT03901105|EG000|Reported Event|Single Arm, Randomly Sequenced Flortaucipir F18 Scans|"No study drug was administered for this study. Scans were previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) and were read by five independent, blinded readers.~Flortaucipir F18: No study drug was administered for this study."
11353249|NCT03895853|BG000|Baseline|Intervention Group (EMR Solution)|Standard of care + Early metabolic resuscitation
11353250|NCT03895853|BG001|Baseline|Controlled Group (Standard Care)|Received standard of care alone
11353251|NCT03895853|BG002|Baseline|Total|Total of all reporting groups
11353252|NCT03895853|FG000|Participant Flow|Intervention Group (EMR Solution)|Standard of care + Early metabolic resuscitation
11353253|NCT03895853|FG001|Participant Flow|Controlled Group (Standard Care)|Received standard of care alone
11353254|NCT03895853|OG000|Outcome|Intervention Group (EMR Solution)|Standard of care + Early metabolic resuscitation
11353255|NCT03895853|OG001|Outcome|Controlled Group (Standard Care)|Received standard of care alone
11353256|NCT03895853|EG000|Reported Event|Intervention Group (EMR Solution)|Standard of care + Early metabolic resuscitation
11353257|NCT03895853|EG001|Reported Event|Controlled Group (Standard Care)|Received standard of care alone
11353258|NCT03901313|BG000|Baseline|All Participants|"Healthy volunteers randomized to receive 1 of 6 sequences of Treatment A, B, and C, with a 6-day washout between treatments, during a stay at the clinic of 20 days~Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions~Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal~Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal"
11353259|NCT03901313|FG000|Participant Flow|Sequence ABC|"Healthy volunteers will receive Treatments A, then B, and then C, with a 6-day washout between treatments, during a stay at the clinic of 20 days~Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions~Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal~Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal"
11353260|NCT03901313|FG001|Participant Flow|Sequence ACB|"Healthy volunteers will receive Treatments A, then C, and then B, with a 6-day washout between treatments, during a stay at the clinic of 20 days~Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions~Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal~Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal"
11353261|NCT03901313|FG002|Participant Flow|Sequence BAC|"Healthy volunteers will receive Treatments B, then A, and then C, with a 6-day washout between treatments, during a stay at the clinic of 20 days~Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions~Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal~Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal"
11353262|NCT03901313|FG003|Participant Flow|Sequence BCA|"Healthy volunteers will receive Treatments B, then C, and then A, with a 6-day washout between treatments, during a stay at the clinic of 20 days~Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions~Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal~Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal"
11353263|NCT03901313|FG004|Participant Flow|Sequence CAB|"Healthy volunteers will receive Treatments C, then A, and then B, with a 6-day washout between treatments, during a stay at the clinic of 20 days~Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions~Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal~Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal"
11353264|NCT03901313|FG005|Participant Flow|Sequence CBA|"Healthy volunteers will receive Treatments C, then B, and then A, with a 6-day washout between treatments, during a stay at the clinic of 20 days~Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions~Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal~Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal"
11353265|NCT03901313|OG000|Outcome|Treatment A|All healthy volunteers who received Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions
11353266|NCT03901313|OG001|Outcome|Treatment B|All healthy volunteers who received Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal
11353267|NCT03901313|OG002|Outcome|Treatment C|All healthy volunteers who received Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal
11353268|NCT03901313|EG000|Reported Event|Treatment A|All healthy volunteers who received Treatment A - 400 mg Fasting: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions
11353269|NCT03901313|EG001|Reported Event|Treatment B|All healthy volunteers who received Treatment B - 400 mg Fed: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal
11353270|NCT03901313|EG002|Reported Event|Treatment C|All healthy volunteers who received Treatment C - 200 mg Fed: Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal
11353271|NCT03901092|BG000|Baseline|All Cases|All eligible subject scans from contributing studies
11353272|NCT03901092|FG000|Participant Flow|All Autopsy Cases|Cases that had a valid scan and came to autopsy in in study A16 and the A16 supplemental cohort
11353273|NCT03901092|FG001|Participant Flow|Non-Autopsy Cases|Mild cognitive impairment (MCI) and AD cases from the A05 confirmatory cohort
11353274|NCT03901092|OG000|Outcome|Sensitivity of Flortaucipir vs Autopsy NFT Score|Subjects with a positive autopsy NFT score truth standard (NFT B3)
11167910|NCT01983020|EG001|Reported Event|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
11167911|NCT01983020|EG002|Reported Event|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
11353275|NCT03901092|OG001|Outcome|Specificity of Flortaucipir vs Autopsy NFT Score|Subjects with a negative autopsy NFT score truth standard (NFT B2 or lower)
11353276|NCT03901092|OG000|Outcome|Sensitivity of Flortaucipir vs NIA-AA Autopsy Diagnosis|Subjects with a positive truth standard (High ADNC)
11353277|NCT03901092|OG001|Outcome|Specificity of Flortaucipir vs NIA-AA Autopsy Diagnosis|Subjects with a negative truth standard (No/Low/Intermediate ADNC)
11353278|NCT03901092|OG000|Outcome|All Cases|All autopsy and non-autopsy cases
11353279|NCT03901092|OG000|Outcome|Sensitivity of Flortaucipir tAD++ vs Autopsy NFT Score|Subjects with a positive autopsy NFT score truth standard (NFT B3)
11353280|NCT03901092|OG001|Outcome|Specificity of Flortaucipir tAD++ vs Autopsy NFT Score|Subjects with a negative autopsy NFT score truth standard (NFT B2 or lower)
11353281|NCT03901092|OG000|Outcome|Sensitivity|Sensitivity individual Flortaucipir PET scan interpreted as τAD++ pattern versus NIA-AA autopsy Diagnosis Truth Standard
11353282|NCT03901092|OG001|Outcome|Specificity|Specificity individual Flortaucipir PET scan interpreted as τAD++ pattern versus NIA-AA autopsy Diagnosis Truth Standard
11353283|NCT03901092|OG000|Outcome|A05 Cases|All non-autopsy cases from the Study A05 population of intended use
11353284|NCT03901092|OG000|Outcome|Randomly Selected Re-reads|Cases randomly selected to be read twice by the same reader
11353285|NCT03901092|EG000|Reported Event|All Cases|No study drug will be administered. Scans previously acquired from Study A16 (NCT02516046) and A05 (NCT02016560) will be read by independent, blinded readers.
11353286|NCT03900728|BG000|Baseline|Auriculotherapy With Needles (Acupuncture) + Usual Care|"A designated trained therapist will perform auriculotherapy with 1mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place until removal at the 1-week follow-up visit~Auriculotherapy with needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353287|NCT03900728|BG001|Baseline|Auriculotherapy With Gold Beads (Acupressure) + Usual Care|"A designated trained therapist will perform auriculotherapy with beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place until removal at the 1-week follow-up visit.~Auriculotherapy with beads: A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears."
11353288|NCT03900728|BG002|Baseline|Placebo Group + Usual Care|"A designated trained therapist will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place until removal at the 1-week follow-up visit.~Placebo Adhesive disks: Single-use adhesive disks without needles or beads."
11353289|NCT03900728|BG003|Baseline|Total|Total of all reporting groups
11353290|NCT03900728|FG000|Participant Flow|Auriculotherapy With Needles (Acupuncture) + Usual Care|"A designated trained therapist will perform auriculotherapy with 1mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place until removal at the 1-week follow-up visit~Auriculotherapy with needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
10887925|NCT00503906|OG000|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
11353291|NCT03900728|FG001|Participant Flow|Auriculotherapy With Gold Beads (Acupressure) + Usual Care|"A designated trained therapist will perform auriculotherapy with beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place until removal at the 1-week follow-up visit.~Auriculotherapy with beads: A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears."
11353292|NCT03900728|FG002|Participant Flow|Placebo Group + Usual Care|"A designated trained therapist will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place until removal at the 1-week follow-up visit.~Placebo Adhesive disks: Single-use adhesive disks without needles or beads."
11353293|NCT03900728|OG000|Outcome|Auriculotherapy With Needles (Acupuncture) + Usual Care|"A designated trained therapist will perform auriculotherapy with 1mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place until removal at the 1-week follow-up visit~Auriculotherapy with needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353294|NCT03900728|OG001|Outcome|Auriculotherapy With Gold Beads (Acupressure) + Usual Care|"A designated trained therapist will perform auriculotherapy with beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place until removal at the 1-week follow-up visit.~Auriculotherapy with beads: A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears."
11353295|NCT03900728|OG002|Outcome|Placebo Group + Usual Care|"A designated trained therapist will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place until removal at the 1-week follow-up visit.~Placebo Adhesive disks: Single-use adhesive disks without needles or beads."
11167912|NCT01983020|EG003|Reported Event|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
11353296|NCT03900728|EG000|Reported Event|Auriculotherapy With Needles (Acupuncture) + Usual Care|"A designated trained therapist will perform auriculotherapy with 1mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place until removal at the 1-week follow-up visit~Auriculotherapy with needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353297|NCT03900728|EG001|Reported Event|Auriculotherapy With Gold Beads (Acupressure) + Usual Care|"A designated trained therapist will perform auriculotherapy with beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place until removal at the 1-week follow-up visit.~Auriculotherapy with beads: A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears."
11167913|NCT01983111|BG000|Baseline|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
11167914|NCT01983111|BG001|Baseline|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
11167915|NCT01983111|BG002|Baseline|Total|Total of all reporting groups
11167916|NCT01983111|FG000|Participant Flow|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
11167917|NCT01983111|FG001|Participant Flow|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
11167918|NCT01983111|OG000|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
11167919|NCT01983111|OG001|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
11167920|NCT01983111|EG000|Reported Event|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days.~Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 69 subjects who administered the study drug(buprenorphine) and had at least one time of safety assessment."
11167921|NCT01983111|EG001|Reported Event|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.~Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 65 subjects who administered the comparator(tramadol/acetaminophen) and had at least one time of safety assessment."
11167922|NCT01983228|BG000|Baseline|Arm 1: Usual Care|Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.
11167923|NCT01983228|BG001|Baseline|Arm 2: Intervention Group|Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
11167924|NCT01983228|BG002|Baseline|Total|Total of all reporting groups
11167925|NCT01983228|FG000|Participant Flow|Arm 1: Usual Care|Participants randomized to the usual care control condition will receive pedometers and an informational brochure.
11167926|NCT01983228|FG001|Participant Flow|Arm 2: Intervention Group|"Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.~Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study."
11167927|NCT01983228|OG000|Outcome|Arm 1: Usual Care|Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.
11167928|NCT01983228|OG001|Outcome|Arm 2: Intervention Group|Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
11167929|NCT01983228|OG000|Outcome|Arm 1: Usual Care|Participants randomized to the usual care control condition will receive pedometers and an informational brochure.
11353298|NCT03900728|EG002|Reported Event|Placebo Group + Usual Care|"A designated trained therapist will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place until removal at the 1-week follow-up visit.~Placebo Adhesive disks: Single-use adhesive disks without needles or beads."
11353299|NCT03900299|BG000|Baseline|Multifocal Breast Cancer Patients Treated Surgically by MRM|multifocal breast cancer patients involved in the study will be randomized to be treated either by oncoplastic breast conserving surgery or modified radical mastectomy(MRM)
11353300|NCT03900299|BG001|Baseline|Multifocal Breast Cancer Patients Treated Surgically by OPS|multifocal breast cancer patients involved in the study randomized in the setting of receiving surgical treatment either modified radical mastectomy (MRM) or oncoplastic breast surgery(OPS)
11353301|NCT03900299|BG002|Baseline|Total|Total of all reporting groups
11353302|NCT03900299|FG000|Participant Flow|Multifocal Breast Cancer Patients Treated Surgically by MRM|multifocal breast cancer patients involved in the study will be randomized to be treated either by oncoplastic breast conserving surgery or modified radical mastectomy(MRM)
11353303|NCT03900299|FG001|Participant Flow|Multifocal Breast Cancer Patients Treated Surgically by OPS|multifocal breast cancer patients involved in the study randomized in the setting of receiving surgical treatment either modified radical mastectomy (MRM) or oncoplastic breast surgery(OPS)
11353304|NCT03900299|OG000|Outcome|Multifocal Breast Cancer Patients Treated Surgically by MRM|multifocal breast cancer patients involved in the study will be randomized to be treated either by oncoplastic breast conserving surgery or modified radical mastectomy(MRM)
11353305|NCT03900299|OG001|Outcome|Multifocal Breast Cancer Patients Treated Surgically by OPS|multifocal breast cancer patients involved in the study randomized in the setting of receiving surgical treatment either modified radical mastectomy (MRM) or oncoplastic breast surgery(OPS)
11353306|NCT03900299|OG000|Outcome|Oncoplastic Breast Surgery|oncoplastic breast surgery: oncoplastic breast surgery with level 1 or 2 according to the case using intra operative frozen section to assess the margin
11353307|NCT03900299|EG000|Reported Event|Multifocal Breast Cancer Patients Treated Surgically by MRM|"multifocal breast cancer patient treated by modified radical mastectomy(MRM) 66 patients~Early complications Haematoma 2 patients out of 56 Seroma 16 patients out of 56 Skin or flap necrosis 5 patients out of 56 Abcess 3 patients out of 56~Late complications Scar fibrosis 2 patients out of 56 keloid 1 patients out of 56"
11353308|NCT03900299|EG001|Reported Event|Multifocal Breast Cancer Patients Treated Surgically by OPS|"multifocal breast cancer patients treated by oncoplastic breast surgery(OPS) 58 patients~Early complications Haematoma 2 patients out of 58 Seroma 10 patients out of 58 Abcess 4 patients out of 58 Skin or NAC necrosis 2 patients out of 58~Late complications Scar fibrosis 3 patients out of 58 keloid 2 patients out of 58 steatonecrosis 5 patients out of 58"
11353309|NCT03898349|BG000|Baseline|Non-Texters|"Patients did not receive the automated text messaging system Annie"
11353310|NCT03898349|BG001|Baseline|Texters|Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
11353311|NCT03898349|BG002|Baseline|Total|Total of all reporting groups
11353312|NCT03898349|FG000|Participant Flow|Non-texters|"Patients who did not receive the automated text messaging system Annie"
11353313|NCT03898349|FG001|Participant Flow|Texters|"Patients who did receive the automated text messaging system Annie~Annie text messaging system: Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.~Annie text messaging system with Usual implementation: Three comparison sites received usual implementation of the automated text messaging system Annie only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls"
11353314|NCT03898349|OG000|Outcome|Non-texters|"Patients who did not receive Annie text messages~Annie text messaging system: Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.~Annie text messaging system with Usual implementation: Three comparison sites received usual implementation of the automated text messaging system Annie only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls"
11353315|NCT03898349|OG001|Outcome|Texters|"Patients who received Annie text messages~Annie text messaging system: Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.~Annie text messaging system with Augmented implementation: Four facilities received the automated text messaging system Annie and our augmented implementation strategy. These facilities had regular facilitation calls, a site visit to assist with implementation, and were given the toolkit, in addition to receiving usual implementation assistance"
11353316|NCT03898349|EG000|Reported Event|Non-texters|Patients who did not receive Annie text messages for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
11353317|NCT03898349|EG001|Reported Event|Texters|Patients who did receive Annie text messages for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
11353318|NCT03897634|BG000|Baseline|Experienced Hearing Aid User|"Single arm study, all participants in this arm. Participants will be experienced hearing aid users.~Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices."
11353319|NCT03897634|FG000|Participant Flow|Experienced Hearing Aid User|"Single arm study, all participants in this arm. Participants will be experienced hearing aid users.~Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices."
11353320|NCT03897634|OG000|Outcome|Experienced Hearing Aid User|"Single arm study, all participants in this arm. Participants will be experienced hearing aid users.~Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices."
11353321|NCT03897634|EG000|Reported Event|Experiences Hearing Aid User|"Single arm study, all participants in this arm. Participants will be experienced hearing aid users.~Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices."
11353322|NCT03895372|BG000|Baseline|Placebo QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
11353323|NCT03895372|BG001|Baseline|Placebo QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
11353324|NCT03895372|BG002|Baseline|PF-06826647 50 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
11353325|NCT03895372|BG003|Baseline|PF-06826647 50 mg QD->PF-06826647 400 mg QD Group|This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
11353326|NCT03895372|BG004|Baseline|PF-06826647 100 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
11353327|NCT03895372|BG005|Baseline|PF-06826647 100 mg QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
11353328|NCT03895372|BG006|Baseline|PF-06826647 200 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
11353329|NCT03895372|BG007|Baseline|PF-06826647 400 mg QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
11353330|NCT03895372|BG008|Baseline|Total|Total of all reporting groups
11167930|NCT01983228|OG001|Outcome|Arm 2: Intervention Group|"Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.~Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study."
11167931|NCT01983228|EG000|Reported Event|Arm 1: Usual Care|Participants randomized to the usual care control condition will receive pedometers and an informational brochure.
11167932|NCT01983228|EG001|Reported Event|Arm 2: Intervention Group|"Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.~Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study."
11167933|NCT01983254|BG000|Baseline|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
11167934|NCT01983254|BG001|Baseline|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
11167935|NCT01983254|BG002|Baseline|Total|Total of all reporting groups
11167936|NCT01983254|FG000|Participant Flow|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
11167937|NCT01983254|FG001|Participant Flow|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
11167938|NCT01983254|OG000|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
11167939|NCT01983254|OG001|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
11167940|NCT01983254|EG000|Reported Event|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
11167941|NCT01983254|EG001|Reported Event|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
11167942|NCT01983293|BG000|Baseline|QLV Study Arm|The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle.
11167943|NCT01983293|BG001|Baseline|Standard of Care Study Arm|The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach.
11167944|NCT01983293|BG002|Baseline|Total|Total of all reporting groups
11167945|NCT01983293|FG000|Participant Flow|QLV Study Arm|The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle.
11167946|NCT01983293|FG001|Participant Flow|Standard of Care Study Arm|The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach.
11167947|NCT01983293|OG000|Outcome|QLV Study Arm|The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle.
11167948|NCT01983293|OG001|Outcome|Standard of Care Study Arm|The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach.
11167949|NCT01983293|EG000|Reported Event|Standard of Care|In the control arm, investigators implanted the LV lead without the use of QLV measurements and instead used standard practices to identify the most suitable LV lead location
11167950|NCT01983293|EG001|Reported Event|QLV Based Lead Implant|In the QLV arm, the implanting physician assessed the QLV in at least two main branches of the coronary sinus for LV lead placement
11167951|NCT01983566|BG000|Baseline|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Dele fasted, followed by a washout phase, followed by Dele after a standardised high-fat, high- calorie meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised low-fat meal.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
11167952|NCT01983566|BG001|Baseline|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
11353331|NCT03895372|FG000|Participant Flow|Placebo QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
11353332|NCT03895372|FG001|Participant Flow|Placebo QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
11353333|NCT03895372|FG002|Participant Flow|PF-06826647 50 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
11353334|NCT03895372|FG003|Participant Flow|PF-06826647 50 mg QD->PF-06826647 400 mg QD Group|This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
11353335|NCT03895372|FG004|Participant Flow|PF-06826647 100 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
11353336|NCT03895372|FG005|Participant Flow|PF-06826647 100 mg QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
11353337|NCT03895372|FG006|Participant Flow|PF-06826647 200 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
11353338|NCT03895372|FG007|Participant Flow|PF-06826647 400 mg QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
11167953|NCT01983566|BG002|Baseline|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele fasted.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
11353339|NCT03895372|OG000|Outcome|Placebo QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
11353340|NCT03895372|OG001|Outcome|PF-06826647 50 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
11353341|NCT03895372|OG002|Outcome|PF-06826647 100 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
11353342|NCT03895372|OG003|Outcome|PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
11353343|NCT03895372|OG004|Outcome|PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
11353344|NCT03895372|OG000|Outcome|Placebo QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
11353345|NCT03895372|OG001|Outcome|Placebo QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
11353346|NCT03895372|OG002|Outcome|PF-06826647 50 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
11353347|NCT03895372|OG003|Outcome|PF-06826647 50 mg QD->PF-06826647 400 mg QD Group|This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
11353348|NCT03895372|OG004|Outcome|PF-06826647 100 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
11353349|NCT03895372|OG005|Outcome|PF-06826647 100 mg QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
11353350|NCT03895372|OG006|Outcome|PF-06826647 200 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
11353351|NCT03895372|OG007|Outcome|PF-06826647 400 mg QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
11353352|NCT03895372|EG000|Reported Event|Placebo QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
11353353|NCT03895372|EG001|Reported Event|Placebo QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
11353354|NCT03895372|EG002|Reported Event|PF-06826647 50 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
11353355|NCT03895372|EG003|Reported Event|PF-06826647 50 mg QD->PF-06826647 400 mg QD Group|This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
11353356|NCT03895372|EG004|Reported Event|PF-06826647 100 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
11353357|NCT03895372|EG005|Reported Event|PF-06826647 100 mg QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
11353358|NCT03895372|EG006|Reported Event|PF-06826647 200 mg QD->PF-06826647 200 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
11353359|NCT03895372|EG007|Reported Event|PF-06826647 400 mg QD->PF-06826647 400 mg QD Group|This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
11353360|NCT03896022|BG000|Baseline|Auriculotherapy - Acupressure With Gold Beads|"A designated trained auriculotherapy provider will place gold beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupressure with Beads: Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353361|NCT03896022|BG001|Baseline|Auriculotherapy - Acupuncture With Pyonex Needles|"A designated trained auriculotherapy provider will place 1.2mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353362|NCT03896022|BG002|Baseline|Placebo Group|"A designated trained auriculotherapy provider will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Placebo Adhesive Disks: Single-use adhesive disks without needles or beads."
11353363|NCT03896022|BG003|Baseline|Total|Total of all reporting groups
11353364|NCT03896022|FG000|Participant Flow|Auriculotherapy - Acupressure With Gold Beads|"A designated trained auriculotherapy provider will place gold beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupressure with Beads: Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353365|NCT03896022|FG001|Participant Flow|Auriculotherapy - Acupuncture With Pyonex Needles|"A designated trained auriculotherapy provider will place 1.2mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353366|NCT03896022|FG002|Participant Flow|Placebo Group|"A designated trained auriculotherapy provider will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Placebo Adhesive Disks: Single-use adhesive disks without needles or beads."
11353367|NCT03896022|OG000|Outcome|Auriculotherapy - Acupressure With Gold Beads|"A designated trained auriculotherapy provider will place gold beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupressure with Beads: Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353368|NCT03896022|OG001|Outcome|Placebo Group|"A designated trained auriculotherapy provider will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Placebo Adhesive Disks: Single-use adhesive disks without needles or beads."
11353369|NCT03896022|OG000|Outcome|Auriculotherapy - Acupuncture With Pyonex Needles|"A designated trained auriculotherapy provider will place 1.2mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11231298|NCT02412371|OG005|Outcome|Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT|"Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231299|NCT02412371|OG000|Outcome|Total|"Participants received veliparib twice daily (BID) in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 or 240 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231300|NCT02412371|EG000|Reported Event|Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 60 mg veliparib BID in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231301|NCT02412371|EG001|Reported Event|Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231302|NCT02412371|EG002|Reported Event|Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231303|NCT02412371|EG003|Reported Event|Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231304|NCT02412371|EG004|Reported Event|Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT|"Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231305|NCT02412371|EG005|Reported Event|Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT|"Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.~After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle."
11231306|NCT02412436|BG000|Baseline|Arm A: Depot Medroxyprogesterone Acetate|At study entry/week 0, participants received depot medroxyprogesterone acetate (DMPA) 150 mg administered intramuscularly as a single dose and co-administered with rifampicin (RIF) and efavirenz (EFV).
11231307|NCT02412436|FG000|Participant Flow|Arm A: Depot Medroxyprogesterone Acetate|At study entry/week 0, participants received depot medroxyprogesterone acetate (DMPA) 150 mg administered intramuscularly as a single dose and co-administered with rifampicin (RIF) and efavirenz (EFV).
11231308|NCT02412436|OG000|Outcome|Arm A: Depot Medroxyprogesterone Acetate|At study entry/week 0, participants received depot medroxyprogesterone acetate (DMPA) 150 mg administered intramuscularly as a single dose and co-administered with rifampicin (RIF) and efavirenz (EFV).
11231309|NCT02412436|EG000|Reported Event|Arm A: Depot Medroxyprogesterone Acetate|At study entry/week 0, participants received depot medroxyprogesterone acetate (DMPA) 150 mg administered intramuscularly as a single dose and co-administered with rifampicin (RIF) and efavirenz (EFV).
11231310|NCT02412488|BG000|Baseline|Out of CathLab Setting|"The insertion of the Reveal LINQ device will be performed in the out-of-cathlab setting.~Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the out-of-cathlab setting (out of the operating room, cardiac catheterization or electrophysiology laboratory)."
11231311|NCT02412488|FG000|Participant Flow|Out of CathLab Setting|"The insertion of the Reveal LINQ device will be performed in the out-of-cathlab setting.~Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the out-of-cathlab setting (out of the operating room, cardiac catheterization or electrophysiology laboratory)."
11231312|NCT02412488|OG000|Outcome|Out of CathLab Setting|"The insertion of the Reveal LINQ device will be performed in the out-of-cathlab setting.~Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the out-of-cathlab setting (out of the operating room, cardiac catheterization or electrophysiology laboratory)."
11231313|NCT02412488|EG000|Reported Event|Out of CathLab Setting|"The insertion of the Reveal LINQ device will be performed in the out-of-cathlab setting.~Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the out-of-cathlab setting (out of the operating room, cardiac catheterization or electrophysiology laboratory)."
11231314|NCT02412501|BG000|Baseline|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System >~> Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
11231315|NCT02412501|FG000|Participant Flow|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System >~> Resolute Onyx Stent - 2.0 mm"
11231316|NCT02412501|OG000|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent >~> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
11231317|NCT02412501|OG000|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent~Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
11231318|NCT02412501|EG000|Reported Event|1. Onyx 2.0mm|Medtronic Onyx 2.0mm
11231319|NCT02412631|BG000|Baseline|Varenicline Plus Placebo|"Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks)~Varenicline: Chantix is an FDA approved medication for smoking cessation~Placebo: Placebo for lorcaserin"
11231320|NCT02412631|BG001|Baseline|Varenicline Plus Lorcaserin|"Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks)~lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients~Varenicline: Chantix is an FDA approved medication for smoking cessation"
11231321|NCT02412631|BG002|Baseline|Total|Total of all reporting groups
11231322|NCT02412631|FG000|Participant Flow|Varenicline Plus Placebo|"Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks)~Varenicline: Chantix is an FDA approved medication for smoking cessation~Placebo: Placebo for lorcaserin"
11231323|NCT02412631|FG001|Participant Flow|Varenicline Plus Lorcaserin|"Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks)~lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients~Varenicline: Chantix is an FDA approved medication for smoking cessation"
11231324|NCT02412631|OG000|Outcome|Varenicline Plus Placebo|"Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks)~Varenicline: Chantix is an FDA approved medication for smoking cessation~Placebo: Placebo for lorcaserin"
11231325|NCT02412631|OG001|Outcome|Varenicline Plus Lorcaserin|"Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks)~lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients~Varenicline: Chantix is an FDA approved medication for smoking cessation"
11231326|NCT02412631|EG000|Reported Event|Varenicline Plus Placebo|"Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks)~Varenicline: Chantix is an FDA approved medication for smoking cessation~Placebo: Placebo for lorcaserin"
11231327|NCT02412631|EG001|Reported Event|Varenicline Plus Lorcaserin|"Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks)~lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients~Varenicline: Chantix is an FDA approved medication for smoking cessation"
11231328|NCT02412644|BG000|Baseline|Apremilast + Apremilast|apremilast + apremilast 30mg bid after week 12
11231329|NCT02412644|BG001|Baseline|Apremilast + Placebo|apremilast + Placebo bid after week 12
11231330|NCT02412644|BG002|Baseline|Total|Total of all reporting groups
11231331|NCT02412644|FG000|Participant Flow|Apremilast + Apremilast|apremilast 30 mg BID for 12 weeks + apremilast 30 mg BID through week 36
11231332|NCT02412644|FG001|Participant Flow|Apremilast + Placebo|apremilast 30 mg BID for 12 weeks + placebo BID through week 36
11231333|NCT02412644|OG000|Outcome|Apremilast + Apremilast|apremilast + apremilast
11231334|NCT02412644|OG001|Outcome|Apremilast + Placebo|apremilast + placebo
11231335|NCT02412644|OG000|Outcome|Apremilast|apremilast
11231336|NCT02412644|OG000|Outcome|Apremilast + Apremilast|apremilast 30 mg BID for 12 weeks + apremilast 30 mg BID through week 36
11231337|NCT02412644|OG001|Outcome|Apremilast + Placebo|apremilast 30 mg BID for 12 weeks + placebo BID through week 36
11231338|NCT02412644|EG000|Reported Event|Apremilast 30mg BID First 12 Weeks|apremilast 30mg bid for 12 weeks
11231339|NCT02412644|EG001|Reported Event|Apremilast 30mg BID After 12 Weeks|apremilast bid after week 12
11231340|NCT02412644|EG002|Reported Event|Placebo BID After 12 Weeks|placebo bid after week 12
11231341|NCT02412657|BG000|Baseline|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
11231342|NCT02412657|BG001|Baseline|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
11231343|NCT02412657|BG002|Baseline|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
11231344|NCT02412657|BG003|Baseline|Total|Total of all reporting groups
11167954|NCT01983566|BG003|Baseline|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
11167955|NCT01983566|BG004|Baseline|Total|Total of all reporting groups
11167956|NCT01983566|FG000|Participant Flow|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Deleobuvir (Dele) film-coated tablets after an overnight fast of at least 10 hours (h), followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
11167957|NCT01983566|FG001|Participant Flow|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
11167958|NCT01983566|FG002|Participant Flow|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
11167959|NCT01983566|FG003|Participant Flow|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
11167960|NCT01983566|OG000|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
11167961|NCT01983566|OG001|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
11167962|NCT01983566|OG002|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
11167963|NCT01983566|OG003|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
11167964|NCT01983566|EG000|Reported Event|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
11167965|NCT01983566|EG001|Reported Event|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
11167966|NCT01983566|EG002|Reported Event|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
11167967|NCT01983566|EG003|Reported Event|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
11167968|NCT01983566|EG004|Reported Event|OMP Alone|One gastro-resistant hard capsule of Omeprazole (OMP) (40 mg) once daily in the evening for 4 days administered oral with 240 mL of water.
11167969|NCT01983683|BG000|Baseline|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
11167970|NCT01983683|BG001|Baseline|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
11167971|NCT01983683|BG002|Baseline|Total|Total of all reporting groups
11353370|NCT03896022|OG001|Outcome|Auriculotherapy - Acupuncture With Pyonex Needles|"A designated trained auriculotherapy provider will place 1.2mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353371|NCT03896022|OG002|Outcome|Placebo Group|"A designated trained auriculotherapy provider will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Placebo Adhesive Disks: Single-use adhesive disks without needles or beads."
11353372|NCT03896022|EG000|Reported Event|Auriculotherapy - Acupressure With Gold Beads|"A designated trained auriculotherapy provider will place gold beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupressure with Beads: Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353373|NCT03896022|EG001|Reported Event|Auriculotherapy - Acupuncture With Pyonex Needles|"A designated trained auriculotherapy provider will place 1.2mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Acupuncture with Needles: Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape."
11353374|NCT03896022|EG002|Reported Event|Placebo Group|"A designated trained auriculotherapy provider will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place during the aspiration abortion and will be removed before the participant is discharged home.~Placebo Adhesive Disks: Single-use adhesive disks without needles or beads."
11353375|NCT03891862|BG000|Baseline|Placebo-controlled Placebo|Participants received placebo (matching valbenazine) once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
11353376|NCT03891862|BG001|Baseline|Placebo-controlled Valbenazine|Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
11353377|NCT03891862|BG002|Baseline|Total|Total of all reporting groups
11353378|NCT03891862|FG000|Participant Flow|Open-label Valbenazine|Participants received valbenazine 40 mg once daily for 1 week, then 80 mg once daily for the remainder of the 8-week open label period.
11353379|NCT03891862|FG001|Participant Flow|Placebo-controlled Placebo|Participants received placebo (matching valbenazine) once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
11353380|NCT03891862|FG002|Participant Flow|Placebo-controlled Valbenazine|Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
11353381|NCT03891862|OG000|Outcome|Placebo-controlled Placebo|Participants received placebo (matching valbenazine) once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
11353382|NCT03891862|OG001|Outcome|Placebo-controlled Valbenazine|Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
11353383|NCT03891862|EG000|Reported Event|Open-label Valbenazine|Participants received valbenazine 40 mg once daily for 1 week, then 80 mg once daily for the remainder of the 8-week open label period.
11353384|NCT03891862|EG001|Reported Event|Placebo-controlled Placebo|Participants received placebo (matching valbenazine) once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
11353385|NCT03891862|EG002|Reported Event|Placebo-controlled Valbenazine|Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
11353386|NCT03894449|BG000|Baseline|Placebo Only|Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
11353387|NCT03894449|BG001|Baseline|Prebiotic Inulin & Iron Salt NaFeEDTA|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects.
11353388|NCT03894449|BG002|Baseline|Prebiotic Inulin & Iron Salt NaFeEDTA (2)|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects.
11353389|NCT03894449|BG003|Baseline|Prebiotic Inulin & Iron Salt FeS04|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects.
11353390|NCT03894449|BG004|Baseline|Prebiotic GOS & Iron Salt NaFeEDTA|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects.
11353391|NCT03894449|BG005|Baseline|Total|Total of all reporting groups
11353392|NCT03894449|FG000|Participant Flow|Placebo Only|Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
11353393|NCT03894449|FG001|Participant Flow|Prebiotic Inulin & Iron Salt NaFeEDTA|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects.
11353394|NCT03894449|FG002|Participant Flow|Prebiotic Inulin & Iron Salt NaFeEDTA (2)|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects.
11353395|NCT03894449|FG003|Participant Flow|Prebiotic Inulin & Iron Salt FeS04|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects.
11353396|NCT03894449|FG004|Participant Flow|Prebiotic GOS & Iron Salt NaFeEDTA|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects.
11353397|NCT03894449|OG000|Outcome|Placebo Only|Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
11353398|NCT03894449|OG001|Outcome|Prebiotic Inulin & Iron Salt FeSO4|Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
11353399|NCT03894449|OG002|Outcome|Prebiotic GOS & Iron Salt FeSO4|Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
11353400|NCT03894449|OG003|Outcome|Prebiotic Inulin & Iron Salt NaFeEDTA|Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
11353401|NCT03894449|OG004|Outcome|Prebiotic GOS & Iron Salt NaFeEDTA|Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
11353402|NCT03894449|EG000|Reported Event|Placebo Only|Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
11353403|NCT03894449|EG001|Reported Event|Prebiotic Inulin & Iron Salt NaFeEDTA|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects.
11353404|NCT03894449|EG002|Reported Event|Prebiotic Inulin & Iron Salt NaFeEDTA (2)|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects.
11353405|NCT03894449|EG003|Reported Event|Prebiotic Inulin & Iron Salt FeS04|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects.
11353406|NCT03894449|EG004|Reported Event|Prebiotic GOS & Iron Salt NaFeEDTA|Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects.
11353407|NCT03892564|BG000|Baseline|Test Sites|"5 test sites on the subject's back defined as:~- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation~- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation~- One application of MC2-01 vehicle, followed by irradiation.~- One application of MC2-01 vehicle, non-irradiation.~- Control site (no application, only irradiated)~to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation"
11353408|NCT03892564|FG000|Participant Flow|Test Sites|"5 test sites on the subject's back defined as:~- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation~- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation~- One application of MC2-01 vehicle, followed by irradiation.~- One application of MC2-01 vehicle, non-irradiation.~- Control site (no application, only irradiated)~to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation"
11353409|NCT03892564|OG000|Outcome|Test Sites|"- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation~- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation~- One application of MC2-01 vehicle, followed by irradiation.~- One application of MC2-01 vehicle, non-irradiation.~- control, irradiated"
11353410|NCT03892564|OG000|Outcome|Test Sites|"5 test sites on the subject's back defined as:~- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation~- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation~- One application of MC2-01 vehicle, followed by irradiation.~- One application of MC2-01 vehicle, non-irradiation.~- control, irradiated~to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation"
11353411|NCT03892564|EG000|Reported Event|MC2-01 Cream, Irradiation|"5 test sites on the subject's back defined as:~- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation~- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation~- One application of MC2-01 vehicle, followed by irradiation.~- One application of MC2-01 vehicle, non-irradiation.~- control, irradiated"
11353412|NCT03892707|BG000|Baseline|NSAIDs Group|Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors)
11353413|NCT03892707|BG001|Baseline|NSAIDs+Milgamma+Milgamma Compositum Group|"Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum Milgamma®: 2 mL injection solution containing thiamin hydrochloride 100 mg, pyridoxine hydrochloride 100 mg, cyanocobalamin 1 mg, lidocaine hydrochloride 20 mg.~Milgamma® compositum: 1 tablet containing benfotiamine 100 mg, pyridoxine hydrochloride 100 mg."
11353414|NCT03892707|BG002|Baseline|Total|Total of all reporting groups
11353415|NCT03892707|FG000|Participant Flow|NSAIDs Group|Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective cyclooxygenase-2 (COX-2) inhibitors)
11167972|NCT01983683|FG000|Participant Flow|Cadazolid|Subjects with Clostridium difficile-associated diarrhea (CDAD) received oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times a day (qid) for 10 days. Subjects were followed up for 30 days after the last dose of cadazolid. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 days of cadazolid + 30-day follow up)
11167973|NCT01983683|FG001|Participant Flow|Vancomycin|Subjects with CDAD received oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days. Subjects were followed up for 30 day after the last dose of vancomycin. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 days of cadazolid + 30-day follow up)
11167974|NCT01983683|OG000|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
11167975|NCT01983683|OG001|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
11167976|NCT01983683|EG000|Reported Event|Cadazolid|oral cadazolid 250 mg twice daily (bid) for 10 days
11167977|NCT01983683|EG001|Reported Event|Vancomycin|oral vancomycin 125 mg 4 times per day (qid) for 10 days
11167978|NCT01983787|BG000|Baseline|Pharmacokinetics Piperacillin|Patients with cystic fibrosis and pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
11167979|NCT01983787|FG000|Participant Flow|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
11167980|NCT01983787|OG000|Outcome|Pharmacokinetics Piperacillin 16g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks.
11167981|NCT01983787|OG001|Outcome|Pharmacokinetics Piperacillin 12g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.
11167982|NCT01983787|OG000|Outcome|T>MIC 16g/Day, Patient 1|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167983|NCT01983787|OG001|Outcome|T>MIC 16g/Day, Patient 2|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167984|NCT01983787|OG002|Outcome|T>MIC 16g/Day, Patient 3|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167985|NCT01983787|OG003|Outcome|T>MIC 16g/Day, Patient 4|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167986|NCT01983787|OG004|Outcome|T>MIC12g/Day, Patient 6|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167987|NCT01983787|OG005|Outcome|T>MIC 12g/Day, Patient 7|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167988|NCT01983787|OG006|Outcome|T>MIC 12g/Day, Patient 8|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167989|NCT01983787|OG007|Outcome|T>MIC 12g/Day, Patient 9|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Acromobacter. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167990|NCT01983787|OG008|Outcome|T>MIC 12g/Day, Patient 10|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
11167991|NCT01983787|OG000|Outcome|Patient 1|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
11167992|NCT01983787|OG001|Outcome|Patient 2|MIC (mg/L) of pathogen detected in sputum: 8 mg/L
11167993|NCT01983787|OG002|Outcome|Patient 3|MIC (mg/L) of pathogen detected in sputum: 16 mg/L
11167994|NCT01983787|OG003|Outcome|Patient 4|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
11167995|NCT01983787|OG004|Outcome|Patient 6|MIC (mg/L) of pathogen detected in sputum: 0.5 mg/L
11167996|NCT01983787|OG005|Outcome|Patient 7|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
11167997|NCT01983787|OG006|Outcome|Patient 8|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
11167998|NCT01983787|OG007|Outcome|Patient 9|MIC (mg/L) of pathogen detected in sputum: 0.75 mg/L
11167999|NCT01983787|OG008|Outcome|Patient 10|MIC (mg/L) of pathogen detected in sputum: 2 mg/L
11168000|NCT01983787|EG000|Reported Event|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
11168001|NCT01983826|BG000|Baseline|Sodium Nitrate (NaNO3)|Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks
11168002|NCT01983826|BG001|Baseline|Placebo|Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks
11168003|NCT01983826|BG002|Baseline|Total|Total of all reporting groups
11168004|NCT01983826|FG000|Participant Flow|Sodium Nitrate (NaNO3)|Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks
11168005|NCT01983826|FG001|Participant Flow|Placebo|Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks
11168006|NCT01983826|OG000|Outcome|Sodium Nitrate (NaNO3) Pre|Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
11168007|NCT01983826|OG001|Outcome|Sodium Nitrate (NaNO3) Post|Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures
11168008|NCT01983826|OG002|Outcome|Placebo - Pre|Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures
11168009|NCT01983826|OG003|Outcome|Placebo - Post|Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
11168010|NCT01983826|EG000|Reported Event|Sodium Nitrate (NaNO3) Pre|Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
11168011|NCT01983826|EG001|Reported Event|Sodium Nitrate (NaNO3) Post|Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures
11168012|NCT01983826|EG002|Reported Event|Placebo - Pre|Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures
11168013|NCT01983826|EG003|Reported Event|Placebo - Post|Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
11168014|NCT01983839|BG000|Baseline|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
11168015|NCT01983839|FG000|Participant Flow|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
11168016|NCT01983839|OG000|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.~The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
11168017|NCT01983839|EG000|Reported Event|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
11168018|NCT01983878|BG000|Baseline|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
11168019|NCT01983878|FG000|Participant Flow|Ramucirumab 8 mg/kg|Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment continued until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
11168020|NCT01983878|OG000|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
11168021|NCT01983878|OG000|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
11168022|NCT01983878|EG000|Reported Event|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
11168023|NCT01983930|BG000|Baseline|Memory Training|"Group memory training will be administered for amnestic MCI~Memory Training: Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks."
11353416|NCT03892707|FG001|Participant Flow|NSAIDs+Milgamma+Milgamma Compositum Group|"Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective cyclooxygenase-2 (COX-2) inhibitors) + Milgamma® / Milgamma® compositum Milgamma®: 2 mL injection solution containing thiamin hydrochloride 100 mg, pyridoxine hydrochloride 100 mg, cyanocobalamin 1 mg, lidocaine hydrochloride 20 mg.~Milgamma® compositum: 1 tablet containing benfotiamine 100 mg, pyridoxine hydrochloride 100 mg."
11353417|NCT03892707|OG000|Outcome|NSAIDs Group|Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors)
11353418|NCT03892707|OG001|Outcome|NSAIDs+Milgamma+Milgamma Compositum Group|"Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum Milgamma®: 2 mL injection solution containing thiamin hydrochloride 100 mg, pyridoxine hydrochloride 100 mg, cyanocobalamin 1 mg, lidocaine hydrochloride 20 mg.~Milgamma® compositum: 1 tablet containing benfotiamine 100 mg, pyridoxine hydrochloride 100 mg."
11353419|NCT03892707|OG000|Outcome|NSAIDs+Milgamma+Milgamma Compositum Group|Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum
11353420|NCT03892707|EG000|Reported Event|NSAIDs Group|Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors)
11353421|NCT03892707|EG001|Reported Event|NSAIDs+Milgamma+Milgamma Compositum Group|"Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum Milgamma®: 2 mL injection solution containing thiamin hydrochloride 100 mg, pyridoxine hydrochloride 100 mg, cyanocobalamin 1 mg, lidocaine hydrochloride 20 mg.~Milgamma® compositum: 1 tablet containing benfotiamine 100 mg, pyridoxine hydrochloride 100 mg."
11353422|NCT03892460|BG000|Baseline|Treatment|"Neuromuscular electrical stimulation~neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation"
11353423|NCT03892460|BG001|Baseline|Control|No treatment control
11353424|NCT03892460|BG002|Baseline|Total|Total of all reporting groups
11353425|NCT03892460|FG000|Participant Flow|Treatment|"Neuromuscular electrical stimulation~neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation"
11353426|NCT03892460|FG001|Participant Flow|Control|No treatment control
11353427|NCT03892460|OG000|Outcome|Treatment|"Neuromuscular electrical stimulation~neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation"
11353428|NCT03892460|OG001|Outcome|Control|No treatment control
11353429|NCT03892460|OG000|Outcome|Treatment|Neuromuscular electrical stimulation
11353430|NCT03892460|EG000|Reported Event|Treatment|"Neuromuscular electrical stimulation~neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation"
11353431|NCT03892460|EG001|Reported Event|Control|No treatment control
11353432|NCT03891641|BG000|Baseline|Treadling Group|Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
11353433|NCT03891641|BG001|Baseline|Control Group|Control Subjects continue their normal daily activities.
11353434|NCT03891641|BG002|Baseline|Total|Total of all reporting groups
11353435|NCT03891641|FG000|Participant Flow|Treadling Group|Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
11353436|NCT03891641|FG001|Participant Flow|Control Group|Control Subjects continue their normal daily activities.
11353437|NCT03891641|OG000|Outcome|Treadling Group|Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
11353438|NCT03891641|OG001|Outcome|Control Group|Control Subjects continue their normal daily activities.
11353439|NCT03891641|EG000|Reported Event|Treadling Group|Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
11353440|NCT03891641|EG001|Reported Event|Control Group|Control Subjects continue their normal daily activities.
11353441|NCT03889704|BG000|Baseline|Neuromuscular Electrical Stimulation|"The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. It will be applied for 20 minutes per session. For each patient, there will be 2 sessions per week, spaced 3 to 4 days apart. Each patient will participate in 16 sessions over the 8 weeks of the study. There will be 6 patients total.~Omnistim® FX²: The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. The device mimics physiologic patterns of neuron firing."
11353442|NCT03889704|FG000|Participant Flow|Neuromuscular Electrical Stimulation|"The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. It will be applied for 20 minutes per session. For each patient, there will be 2 sessions per week, spaced 3 to 4 days apart. Each patient will participate in 16 sessions over the 8 weeks of the study. There will be 6 patients total.~Omnistim® FX²: The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. The device mimics physiologic patterns of neuron firing."
11353443|NCT03889704|OG000|Outcome|Neuromuscular Electrical Stimulation|"The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. It will be applied for 20 minutes per session. For each patient, there will be 2 sessions per week, spaced 3 to 4 days apart. Each patient will participate in 16 sessions over the 8 weeks of the study. There will be 6 patients total.~Omnistim® FX²: The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. The device mimics physiologic patterns of neuron firing."
11231345|NCT02412657|FG000|Participant Flow|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
11231346|NCT02412657|FG001|Participant Flow|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
11231347|NCT02412657|FG002|Participant Flow|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
11231348|NCT02412657|OG000|Outcome|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
11231349|NCT02412657|OG001|Outcome|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
11231350|NCT02412657|OG002|Outcome|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
11231351|NCT02412657|EG000|Reported Event|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
11231352|NCT02412657|EG001|Reported Event|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
11231353|NCT02412657|EG002|Reported Event|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
11231354|NCT02412722|BG000|Baseline|Single-Agent QD Arm: Sapanisertib 3 mg|Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
11231355|NCT02412722|BG001|Baseline|Single-Agent QD Arm: Sapanisertib 4 mg|Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
11231356|NCT02412722|BG002|Baseline|Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2|Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
11231357|NCT02412722|BG003|Baseline|Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2|Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
11231358|NCT02412722|BG004|Baseline|Single-Agent QW Arm: Sapanisertib 20 mg|Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
11231359|NCT02412722|BG005|Baseline|Single-Agent QW Arm: Sapanisertib 30 mg|Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
11231360|NCT02412722|BG006|Baseline|Total|Total of all reporting groups
11231361|NCT02412722|FG000|Participant Flow|Single-Agent QD Arm: Sapanisertib 3 mg|Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
11231362|NCT02412722|FG001|Participant Flow|Single-Agent QD Arm: Sapanisertib 4 mg|Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
11231363|NCT02412722|FG002|Participant Flow|Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2|Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
11231364|NCT02412722|FG003|Participant Flow|Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2|Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
11231365|NCT02412722|FG004|Participant Flow|Single-Agent QW Arm: Sapanisertib 20 mg|Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
11231366|NCT02412722|FG005|Participant Flow|Single-Agent QW Arm: Sapanisertib 30 mg|Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
11231367|NCT02412722|OG000|Outcome|PK-Run In Period Fasted (Unmilled)|Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
10851301|NCT00305682|EG005|Reported Event|Arm 6 - No Prior Autologous Transplant|Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
11168024|NCT01983930|BG001|Baseline|Kundalini Yoga and Meditation|"Participants will engage in weekly yoga classes and daily 20 minute meditation~Kundalini yoga and meditation: Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan kriya meditation (12 minute duration) for 12 weeks."
11168025|NCT01983930|BG002|Baseline|Total|Total of all reporting groups
11168026|NCT01983930|FG000|Participant Flow|Memory Training|"Group memory training will be administered for amnestic MCI~Memory Training: Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks."
11168027|NCT01983930|FG001|Participant Flow|Kundalini Yoga and Meditation|"PArticipants will engage in weekly yoga classes and daily 20 minute meditation~Kundalini yoga and meditation: Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan kriya meditation (12 minute duration) for 12 weeks."
11168028|NCT01983930|OG000|Outcome|Memory Training|"Group memory training will be administered for amnestic MCI.~Memory Training: Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks."
11168029|NCT01983930|OG001|Outcome|Kundalini Yoga and Meditation|"Participants will engage in weekly yoga classes and daily 20 minute meditation.~Kundalini yoga and meditation: Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks."
11168030|NCT01983930|OG000|Outcome|Memory Training|"Group memory training will be administered for amnestic mild cognitive impairment (MCI)~Memory Training: Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks."
11168031|NCT01983930|EG000|Reported Event|Memory Training|"Group memory training will be administered for amnestic MCI.~Memory Training: Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks."
11168032|NCT01983930|EG001|Reported Event|Kundalini Yoga and Meditation|"Participants will engage in weekly yoga classes and daily 20 minute meditation.~Kundalini yoga and meditation: Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan kriya meditation (12 minute duration) for 12 weeks."
11168033|NCT01983969|BG000|Baseline|Azacitidine Dose Level 1|Azacitidine 15 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168034|NCT01983969|BG001|Baseline|Azacitidine Dose Level 2|Azacitidine 25 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168035|NCT01983969|BG002|Baseline|Azacitidine Dose Level 3|Azacitidine 35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168036|NCT01983969|BG003|Baseline|Total|Total of all reporting groups
11168037|NCT01983969|FG000|Participant Flow|Azacitidine Dose Level 1|Azacitidine 15 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11168038|NCT01983969|FG001|Participant Flow|Azacitidine Dose Level 2|Azacitidine 25mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11168039|NCT01983969|FG002|Participant Flow|Azacitidine Dose Level 3|Azacitidine 35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11168040|NCT01983969|OG000|Outcome|Azacitidine Dose Level 1|Azacitidine 15 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168041|NCT01983969|OG001|Outcome|Azacitidine Dose Level 2|Azacitidine 25 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168042|NCT01983969|OG002|Outcome|Azacitidine Dose Level 3|Azacitidine 35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168043|NCT01983969|OG000|Outcome|DLBCL|DLBCL patients who received the following: Azacitidine 15 mg/m2-35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168044|NCT01983969|OG001|Outcome|Hodgkin Lymphoma|Hodgkin Lymphoma patients who received the following: Azacitidine 15 mg/m2-35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11231368|NCT02412722|OG001|Outcome|PK-Run In Period Fed (Milled)|Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
11231369|NCT02412722|OG002|Outcome|PK-Run In Period Fasted (Milled)|Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
11231370|NCT02412722|OG003|Outcome|Single-Agent QD Arm: Sapanisertib 3 mg|Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
11231371|NCT02412722|OG004|Outcome|Single-Agent QD Arm: Sapanisertib 4 mg|Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
11231372|NCT02412722|OG005|Outcome|Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2|Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
11231373|NCT02412722|OG006|Outcome|Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2|Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
11231374|NCT02412722|OG007|Outcome|Single-Agent QW Arm: Sapanisertib 20 mg|Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
11231375|NCT02412722|OG008|Outcome|Single-Agent QW Arm: Sapanisertib 30 mg|Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
11231376|NCT02412722|OG000|Outcome|Sapanisertib 4 mg Milled Capsules Under Fed Conditions|Sapanisertib 4 mg milled capsules, orally, once, after a high-fat breakfast, on Days 3 and 5.
11231377|NCT02412722|OG001|Outcome|Sapanisertib 4 mg Milled Capsules Under Fasted Conditions|Sapanisertib 4 mg unmilled capsules, orally, once, under fasted conditions, on Days 3 and 5.
11231378|NCT02412722|OG000|Outcome|Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2|Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
11231379|NCT02412722|OG001|Outcome|Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2|Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
11231380|NCT02412722|OG000|Outcome|Sapanisertib 4 mg Milled Capsules Under Fasted Conditions|Sapanisertib 4 mg Milled capsules, orally, once, under fasted conditions, on Days 1 and 3.
11231381|NCT02412722|OG001|Outcome|Sapanisertib 4 mg Unmilled Capsules Under Fasted Conditions|Sapanisertib 4 mg unmilled capsules, orally, once, under fasted conditions, on Days 1 and 3.
11231382|NCT02412722|OG002|Outcome|Single-Agent QW Arm: Sapanisertib 20 mg|Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
11231383|NCT02412722|OG003|Outcome|Single-Agent QW Arm: Sapanisertib 30 mg|Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
11231384|NCT02412722|OG000|Outcome|Single-Agent QD Arm: Sapanisertib 3 mg|Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
11231385|NCT02412722|OG001|Outcome|Single-Agent QD Arm: Sapanisertib 4 mg|Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
11231386|NCT02412722|OG002|Outcome|Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2|Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
11231387|NCT02412722|OG003|Outcome|Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2|Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
11231388|NCT02412722|OG004|Outcome|Single-Agent QW Arm: Sapanisertib 20 mg|Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
11231389|NCT02412722|OG005|Outcome|Single-Agent QW Arm: Sapanisertib 30 mg|Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
11231390|NCT02412722|EG000|Reported Event|PK-Run In Period Fasted (Unmilled)|Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
11231391|NCT02412722|EG001|Reported Event|PK-Run In Period Fed (Milled)|Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
11231392|NCT02412722|EG002|Reported Event|PK-Run In Period Fasted (Milled)|Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
11231393|NCT02412722|EG003|Reported Event|Single-Agent QD Arm: Sapanisertib 3 mg|Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
11231394|NCT02412722|EG004|Reported Event|Single-Agent QD Arm: Sapanisertib 4 mg|Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
11231395|NCT02412722|EG005|Reported Event|Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2|Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
11168045|NCT01983969|OG002|Outcome|T-cell NHL|T-cell NHL patients who received the following: Azacitidine 15 mg/m2-35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168046|NCT01983969|OG003|Outcome|Other B-cell Lymphoma|Other B-cell lymphoma (Follicular lymphoma and Mantle cell lymphoma) who received the following: Azacitidine 15 mg/m2-35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168047|NCT01983969|EG000|Reported Event|Azacitidine Dose Level 1|Azacitidine 15 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168048|NCT01983969|EG001|Reported Event|Azacitidine Dose Level 2|Azacitidine 25 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168049|NCT01983969|EG002|Reported Event|Azacitidine Dose Level 3|Azacitidine 35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT
11168050|NCT01984164|BG000|Baseline|Candesartan|"To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.~Candesartan: blinded"
11168051|NCT01984164|BG001|Baseline|Lisinopril|"To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.~Lisinopril: Blinded"
11168052|NCT01984164|BG002|Baseline|Total|Total of all reporting groups
11168053|NCT01984164|FG000|Participant Flow|Candesartan|"To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.~Candesartan: blinded"
11168054|NCT01984164|FG001|Participant Flow|Lisinopril|"To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.~Lisinopril: Blinded"
11168055|NCT01984164|OG000|Outcome|Candesartan|"To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.~Candesartan: blinded"
11168056|NCT01984164|OG001|Outcome|Lisinopril|"To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.~Lisinopril: Blinded"
11168057|NCT01984164|EG000|Reported Event|Candesartan|"To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.~Candesartan: blinded"
11168058|NCT01984164|EG001|Reported Event|Lisinopril|"To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.~Lisinopril: Blinded"
11168059|NCT01984229|BG000|Baseline|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
11168060|NCT01984229|BG001|Baseline|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
11168061|NCT01984229|BG002|Baseline|Total|Total of all reporting groups
10851302|NCT00305695|BG000|Baseline|Arm I (Zoledroic Acid)|"Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.~Laboratory Biomarker Analysis: Correlative studies~Zoledronic Acid: Given IV"
11231396|NCT02412722|EG006|Reported Event|Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2|Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
11231397|NCT02412722|EG007|Reported Event|Single-Agent QW Arm: Sapanisertib 20 mg|Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
11231398|NCT02412722|EG008|Reported Event|Single-Agent QW Arm: Sapanisertib 30 mg|Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
11231399|NCT02412761|BG000|Baseline|Participants Who Completed N-of-1 Trials|Participants who completed the first treatment cycle in the n-of-1 trial
11231400|NCT02412761|FG000|Participant Flow|Amlodipine, Then HCTZ, Then Lisinopril|Participants first received amlodipine once daily for 2 weeks, then crossed over to hydrochlorothiazide (HCTZ) once daily for 2 weeks, then lisinopril once daily for 2 weeks. Subsequent treatments varied depending on individual patient response
11231401|NCT02412761|FG001|Participant Flow|Amlodipine, Then Lisinopril, Then HCTZ|Participants first received amlodipine once daily for 2 weeks, then crossed over to lisinopril once daily for 2 weeks, then hydrochlorothiazide (HCTZ) once daily for 2 weeks. Subsequent treatments varied depending on individual patient response.
11231402|NCT02412761|FG002|Participant Flow|HCTZ, Then Amlodipine, Then Lisinopril|Participants first received hydrochlorothiazide (HCTZ) once daily for 2 weeks, then crossed over to amlodipine once daily for 2 weeks, then lisinopril once daily for 2 weeks. Subsequent treatments varied depending on individual patient response.
11231403|NCT02412761|FG003|Participant Flow|HCTZ, Then Lisinopril, Then Amlodipine|Participants first received hydrochlorothiazide (HCTZ) once daily for 2 weeks, then crossed over to lisinopril once daily for 2 weeks, then amlodipine once daily for 2 weeks. Subsequent treatments varied depending on individual patient response.
11231404|NCT02412761|FG004|Participant Flow|Lisinopril, Then Amlodipine, Then HCTZ|Participants first received lisinopril once daily for 2 weeks, then crossed over to amlodipine once daily for 2 weeks, then hydrochlorothiazide (HCTZ) once daily for 2 weeks. Subsequent treatments varied depending on individual patient response.
11231405|NCT02412761|FG005|Participant Flow|Lisinopril, Then HCTZ, Then Amlodipine|Participants first received lisinopril once daily for 2 weeks, then crossed over to hydrochlorothiazide (HCTZ) once daily for 2 weeks, then amlodipine once daily for 2 weeks. Subsequent treatments varied depending on individual patient response.
11231406|NCT02412761|OG000|Outcome|Lisinopril|Lisinopril: Initial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 10 mg/dose). Maximum final dose: 40 mg/dose or 0.6 mg/kg/dose.
11231407|NCT02412761|OG001|Outcome|Amlodipine|Amlodipine: Initial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 5 mg/dose). Maximum final dose: 10 mg/dose
11231408|NCT02412761|OG002|Outcome|Hydrochlorothiazide|Hydrochlorothiazide: Initial dose: 1 mg/kg/dose orally, once daily (maximum initial dose 25 mg/dose). Maximum final dose: 50 mg/dose or 3 mg/kg/dose
11231409|NCT02412761|EG000|Reported Event|Lisinopril|Lisinopril: Initial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 10 mg/dose). Maximum final dose: 40 mg/dose or 0.6 mg/kg/dose.
11231410|NCT02412761|EG001|Reported Event|Amlodipine|Amlodipine: Initial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 5 mg/dose). Maximum final dose: 10 mg/dose
11231411|NCT02412761|EG002|Reported Event|Hydrochlorothiazide|Hydrochlorothiazide: Initial dose: 1 mg/kg/dose orally, once daily (maximum initial dose 25 mg/dose). Maximum final dose: 50 mg/dose or 3 mg/kg/dose
11231412|NCT02412852|BG000|Baseline|Placebo|"One placebo tablet administered twice daily for 12 weeks.~Placebo: Placebo tablets"
11231413|NCT02412852|BG001|Baseline|40 mg TV1001sr|"One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.~Sodium nitrite: Sustained release formulation of sodium nitrite"
10851303|NCT00305695|BG001|Baseline|Arm II (Clinical Observation)|Patients are observed for 18 months after surgery.
11231414|NCT02412852|BG002|Baseline|Placebo (2)|"Two placebo tablets administered twice daily for 12 weeks.~Placebo: Placebo tablets"
11231415|NCT02412852|BG003|Baseline|80 mg TV1001sr|"Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.~Sodium nitrite: Sustained release formulation of sodium nitrite"
11231416|NCT02412852|BG004|Baseline|Total|Total of all reporting groups
11231417|NCT02412852|FG000|Participant Flow|Placebo|"One placebo tablet administered twice daily for 12 weeks.~Placebo: Placebo tablets"
11231418|NCT02412852|FG001|Participant Flow|40 mg TV1001sr|"One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.~Sodium nitrite: Sustained release formulation of sodium nitrite"
11231419|NCT02412852|FG002|Participant Flow|Placebo (2)|"Two placebo tablets administered twice daily for 12 weeks.~Placebo: Placebo tablets"
11231420|NCT02412852|FG003|Participant Flow|80 mg TV1001sr|"Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.~Sodium nitrite: Sustained release formulation of sodium nitrite"
11231421|NCT02412852|OG000|Outcome|Combined Placebo|A combination of the once/day and twice/day placebo groups.
11231422|NCT02412852|OG001|Outcome|40 mg TV1001sr|Treatment twice daily with 40 mg sustained release sodium nitrite
11231423|NCT02412852|OG002|Outcome|80 mg TV1001sr|Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
11231424|NCT02412852|EG000|Reported Event|Combined Placebo|A combination of the once/day and twice/day placebo groups.
11231425|NCT02412852|EG001|Reported Event|40 mg TV1001sr|Treatment twice daily with 40 mg sustained release sodium nitrite
11231426|NCT02412852|EG002|Reported Event|80 mg TV1001sr|Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
11231427|NCT02412878|BG000|Baseline|Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone|"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).~Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15."
11353444|NCT03889704|EG000|Reported Event|Neuromuscular Electrical Stimulation|"The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. It will be applied for 20 minutes per session. For each patient, there will be 2 sessions per week, spaced 3 to 4 days apart. Each patient will participate in 16 sessions over the 8 weeks of the study. There will be 6 patients total.~Omnistim® FX²: The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. The device mimics physiologic patterns of neuron firing."
11353445|NCT03889444|BG000|Baseline|OZURDEX®|Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
11353446|NCT03889444|FG000|Participant Flow|OZURDEX®|Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
11353447|NCT03889444|OG000|Outcome|OZURDEX®|Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
11353448|NCT03889444|EG000|Reported Event|OZURDEX®|Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
11353449|NCT03888755|BG000|Baseline|Icatibant|Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
11353450|NCT03888755|FG000|Participant Flow|Icatibant|Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
11353451|NCT03888755|OG000|Outcome|Icatibant|Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
11353452|NCT03888755|OG000|Outcome|Icatibant|Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
11353453|NCT03888755|OG000|Outcome|Icatibant|Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart could have been given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
11353454|NCT03888755|EG000|Reported Event|Icatibant|Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
11353455|NCT03888391|BG000|Baseline|Active TNS|"Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial.~Active TNS:"
11353456|NCT03888391|FG000|Participant Flow|Active TNS|Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial.
11353457|NCT03888391|OG000|Outcome|Active TNS|Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial.
11353458|NCT03888391|EG000|Reported Event|Active TNS|Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial.
11353459|NCT03888482|BG000|Baseline|DDT2, Then Clariti|"Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.~Verofilcon A contact lenses: Investigational daily disposable soft contact lenses~Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses"
11353460|NCT03888482|BG001|Baseline|Clariti, Then DDT2|"Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.~Verofilcon A contact lenses: Investigational daily disposable soft contact lenses~Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses"
11353461|NCT03888482|BG002|Baseline|Total|Total of all reporting groups
11353462|NCT03888482|FG000|Participant Flow|DDT2, Then Clariti|Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
11353463|NCT03888482|FG001|Participant Flow|Clariti, Then DDT2|Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
11353464|NCT03888482|OG000|Outcome|DDT2|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353465|NCT03888482|OG001|Outcome|Clariti|Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353466|NCT03888482|EG000|Reported Event|DDT2 - Ocular|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353467|NCT03888482|EG001|Reported Event|DDT2 - Systemic / Nonocular|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
10851304|NCT00305695|BG002|Baseline|Total|Total of all reporting groups
11353468|NCT03888482|EG002|Reported Event|Clariti - Ocular|Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353469|NCT03888482|EG003|Reported Event|Clariti - Systemic / Nonocular|Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353470|NCT03888274|BG000|Baseline|Active|ClearUP Sinus Pain Relief: Microcurrent Device Treatment
11353471|NCT03888274|FG000|Participant Flow|Active|ClearUP Sinus Pain Relief: Microcurrent Device Treatment
11353472|NCT03888274|OG000|Outcome|Active|ClearUP Sinus Pain Relief: Microcurrent Device Treatment
11353473|NCT03888274|EG000|Reported Event|Active|ClearUP Sinus Pain Relief: Microcurrent Device Treatment
11353474|NCT03888365|BG000|Baseline|Cohort A: Treprostinil|Participants who were currently prescribed and using inhaled treprostinil for the treatment of PAH.
11353475|NCT03888365|BG001|Baseline|Cohort B: Non-Treprostinil PAH Medications|Participants who were taking other PAH medications (instead of inhaled treprostinil).
11353476|NCT03888365|BG002|Baseline|Total|Total of all reporting groups
11353477|NCT03888365|FG000|Participant Flow|Cohort A: Treprostinil|Participants who were currently prescribed and using inhaled treprostinil for the treatment of PAH.
11353478|NCT03888365|FG001|Participant Flow|Cohort B: Non-Treprostinil PAH Medications|Participants who were taking other PAH medications (instead of inhaled treprostinil).
11353479|NCT03888365|OG000|Outcome|Cohort A: Treprostinil|Participants who were currently prescribed and using inhaled treprostinil for the treatment of PAH.
11353480|NCT03888365|OG000|Outcome|Cohort B: Non-Treprostinil PAH Medications|Participants who were taking other PAH medications (instead of inhaled treprostinil).
11353481|NCT03888365|OG001|Outcome|Cohort B: Non-Treprostinil PAH Medications|Participants who were taking other PAH medications (instead of inhaled treprostinil).
11353482|NCT03888365|EG000|Reported Event|Cohort A: Treprostinil|Participants who were currently prescribed and using inhaled treprostinil for the treatment of PAH.
11353483|NCT03888365|EG001|Reported Event|Cohort B: Non-Treprostinil PAH Medications|Participants who were taking other PAH medications (instead of inhaled treprostinil).
11353484|NCT03888469|BG000|Baseline|DDT2, Then 1DAVM|Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
11353485|NCT03888469|BG001|Baseline|1DAVM, Then DDT2|Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
11353486|NCT03888469|BG002|Baseline|Total|Total of all reporting groups
11353487|NCT03888469|FG000|Participant Flow|DDT2, Then 1DAVM|Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
11353488|NCT03888469|FG001|Participant Flow|1DAVM, Then DDT2|Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
11353489|NCT03888469|OG000|Outcome|DDT2|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353490|NCT03888469|OG001|Outcome|1DAVM|Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353491|NCT03888469|EG000|Reported Event|DDT2 - Ocular|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353492|NCT03888469|EG001|Reported Event|DDT2 - Systemic / Nonocular|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353493|NCT03888469|EG002|Reported Event|1DAVM - Ocular|Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353494|NCT03888469|EG003|Reported Event|1DAVM - Systemic / Nonocular|Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
11353495|NCT03887442|BG000|Baseline|Paclitaxel|"Paclitaxel 80 mg/m2 may be infused, intravenously, every week.~Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week."
11353496|NCT03887442|BG001|Baseline|Cetuximab + Paclitaxel|"Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.~Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel."
11353497|NCT03887442|BG002|Baseline|Total|Total of all reporting groups
11353498|NCT03887442|FG000|Participant Flow|Paclitaxel|"Paclitaxel 80 mg/m2 may be infused, intravenously, every week.~Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week."
11353499|NCT03887442|FG001|Participant Flow|Cetuximab + Paclitaxel|"Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.~Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel."
11353500|NCT03887442|OG000|Outcome|Paclitaxel|"Paclitaxel 80 mg/m2 may be infused, intravenously, every week.~Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week."
11353501|NCT03887442|OG001|Outcome|Cetuximab + Paclitaxel|"Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.~Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel."
11353502|NCT03887442|OG000|Outcome|Cetuximab + Paclitaxel|"Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.~Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel."
11353503|NCT03887442|OG001|Outcome|Paclitaxel|"Paclitaxel 80 mg/m2 may be infused, intravenously, every week.~Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week."
11353504|NCT03887442|EG000|Reported Event|Paclitaxel|"Paclitaxel 80 mg/m2 may be infused, intravenously, every week.~Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week."
11353505|NCT03887442|EG001|Reported Event|Cetuximab + Paclitaxel|"Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.~Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel."
11353506|NCT03887286|BG000|Baseline|Treatment Group|"All participants to receive standard transthoracic echocardiogram and hand held echocardiogram~Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography~Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device"
11353507|NCT03887286|FG000|Participant Flow|Treatment Group|"All participants to receive standard transthoracic echocardiogram and hand held echocardiogram~Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography~Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device"
11353508|NCT03887286|OG000|Outcome|Standard Transthoracic Echocardiogram Intervention|The transthoracic echocardiogram was performed and read via Intersocietal Commission Accreditation Echocardiography Laboratories (ICAEL) standard
11353509|NCT03887286|OG001|Outcome|Hand Held Echocardiography|The hand held echocardiogram was performed and read via Intersocietal Commission Accreditation Echocardiography Laboratories (ICAEL) standard
10851305|NCT00305695|FG000|Participant Flow|Arm I (Zoledroic Acid)|"Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.~Laboratory Biomarker Analysis: Correlative studies~Zoledronic Acid: Given IV"
11353510|NCT03887286|EG000|Reported Event|Treatment Group|"All participants to receive standard transthoracic echocardiogram and hand held echocardiogram~Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography~Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device"
11353511|NCT03881007|BG000|Baseline|LCM (Intervention), Then Placebo|Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex for 3 months and then switch to placebo mouthwash for 3 months.
11353512|NCT03881007|BG001|Baseline|Placebo, Then LCM|Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex for 3 months and then switch to LCM mouthwash for 3 months.
11353513|NCT03881007|BG002|Baseline|Total|Total of all reporting groups
11353514|NCT03881007|FG000|Participant Flow|LCM (Intervention), Then Placebo|Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex for 3 months and after 3 months they will switch to the placebo.
10851306|NCT00305695|FG001|Participant Flow|Arm II (Clinical Observation)|Patients are observed for 18 months after surgery.
11353515|NCT03881007|FG001|Participant Flow|Placebo, Then LCM (Intervention)|Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex during 3 months and after 3 months they will switch to the LCM mouthwash.
11353516|NCT03881007|OG000|Outcome|LCM (Intervention)|Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex
11353517|NCT03881007|OG001|Outcome|Placebo|Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex
11353518|NCT03881007|EG000|Reported Event|LCM (Intervention)|Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex. The total of participants at risk for the LCM intervention is 195 (121 in first 3 months and 77 in last 3 months).
11353519|NCT03881007|EG001|Reported Event|Placebo|Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex. The total of participants at risk for the LCM intervention is 196 (119 in first 3 months and 74 in last 3 months).
11353520|NCT03878602|BG000|Baseline|Control Group|"Newborns will be subjected to umbilical cord immediate clamping~Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn"
11353521|NCT03878602|BG001|Baseline|Study Group|"Newborns will be subjected to umbilical cord delayed clamping~Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn"
11353522|NCT03878602|BG002|Baseline|Total|Total of all reporting groups
11353523|NCT03878602|FG000|Participant Flow|Immediate Clamping|"Newborns will be subjected to umbilical cord immediate clamping~Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn"
11353524|NCT03878602|FG001|Participant Flow|Delayed Clamping|"Newborns will be subjected to umbilical cord delayed clamping~Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn"
11353525|NCT03878602|OG000|Outcome|Control Group|"Newborns will be subjected to umbilical cord immediate clamping~Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn"
11353526|NCT03878602|OG001|Outcome|Study Group|"Newborns will be subjected to umbilical cord delayed clamping~Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn"
11353527|NCT03878602|OG000|Outcome|Immediate Clamping|"Newborns will be subjected to umbilical cord immediate clamping~Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn"
11353528|NCT03878602|OG001|Outcome|Delayed Clamping|"Newborns will be subjected to umbilical cord delayed clamping~Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn"
11231428|NCT02412878|BG001|Baseline|Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone|"Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).~Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15."
11231429|NCT02412878|BG002|Baseline|Total|Total of all reporting groups
11231430|NCT02412878|FG000|Participant Flow|Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone|"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).~Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15."
11231431|NCT02412878|FG001|Participant Flow|Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone|"Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).~Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15."
11231432|NCT02412878|OG000|Outcome|Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone|"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).~Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15."
11231433|NCT02412878|OG001|Outcome|Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone|"Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).~Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15."
11231434|NCT02412878|EG000|Reported Event|Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone|"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).~Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15."
11231435|NCT02412878|EG001|Reported Event|Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone|"Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).~Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15."
11231436|NCT02412956|BG000|Baseline|Control|Pamphlet
11231437|NCT02412956|BG001|Baseline|Intervention|SmokefreeMOM text messaging program and SmokefreeMOM text messaging program+ Quitline
11231438|NCT02412956|BG002|Baseline|Total|Total of all reporting groups
11231439|NCT02412956|FG000|Participant Flow|Control|pamphlet
11231440|NCT02412956|FG001|Participant Flow|Intervention (Text)|"SmokefreeMOM text messaging program~SmokefreeMOM Text"
10851307|NCT00305695|OG000|Outcome|Arm I (Zoledroic Acid)|"Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.~Laboratory Biomarker Analysis: Correlative studies~Zoledronic Acid: Given IV"
11231441|NCT02412956|FG002|Participant Flow|Intervention Plus (Text+Quitline)|"SmokefreeMOM text messaging program + state quitline~SmokefreeMOM Text"
11231442|NCT02412956|OG000|Outcome|Control|pamphlet
11231443|NCT02412956|OG001|Outcome|Intervention|SmokefreeMOM text messaging program and SmokefreeMOM text messaging program + state quitline
11231444|NCT02412956|EG000|Reported Event|Control|pamphlet
11231445|NCT02412956|EG001|Reported Event|Intervention|SmokefreeMOM text messaging program and SmokefreeMOM text messaging program + state quitline
11231446|NCT02412982|BG000|Baseline|Control: Serum Anti-Xa >= 0.1 IU/mL|Patients with serum anti-Xa level >= 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours
11231447|NCT02412982|BG001|Baseline|Intervention: Serum Anti-Xa < 0.1 IU/mL|Patients with serum anti-Xa level < 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours
11231448|NCT02412982|BG002|Baseline|Total|Total of all reporting groups
11231449|NCT02412982|FG000|Participant Flow|Control Group|"Patients with serum anti-Xa level >= 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours~n = 51 4 with AT-III not collected so 47 included in primary outcome analysis"
11231450|NCT02412982|FG001|Participant Flow|Intervention Group|"Patients with serum anti-Xa < 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours~n = 52~1 patient withdrew consent; 2 patients did not have AT-III collected. 49 total included in primary outcome analyses."
11231451|NCT02412982|OG000|Outcome|Control Group|"Patients with serum anti-Xa level >= 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours~n = 51 4 with AT-III not collected so 47 included in primary outcome analysis"
11231452|NCT02412982|OG001|Outcome|Intervention Group|"Patients with serum anti-Xa < 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours~n = 52~1 patient withdrew consent; 2 patients did not have AT-III collected. 49 total included in primary outcome analyses."
11231453|NCT02412982|EG000|Reported Event|Control Group|"Patients with serum anti-Xa level >= 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours~n = 51 4 with AT-III not collected so 47 included in primary outcome analysis"
11231454|NCT02412982|EG001|Reported Event|Intervention Group|"Patients with serum anti-Xa < 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours~n = 52~1 patient withdrew consent; 2 patients did not have AT-III collected. 49 total included in primary outcome analyses."
11231455|NCT02413008|BG000|Baseline|0.005% Estriol Vaginal Gel|"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration~estriol"
11231456|NCT02413008|BG001|Baseline|Placebo Vaginal Gel|"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration~Placebo"
11231457|NCT02413008|BG002|Baseline|Total|Total of all reporting groups
11353529|NCT03878602|EG000|Reported Event|Control Group|"Newborns will be subjected to umbilical cord immediate clamping~Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn"
11353530|NCT03878602|EG001|Reported Event|Study Group|"Newborns will be subjected to umbilical cord delayed clamping~Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn"
11353531|NCT03875118|BG000|Baseline|Mouth-opening Training With Follow-up Calls|"Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.~The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence."
11353532|NCT03875118|BG001|Baseline|Mouth-opening Training Without Follow-up Calls|"Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.~The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks."
11353533|NCT03875118|BG002|Baseline|Total|Total of all reporting groups
11353534|NCT03875118|FG000|Participant Flow|Mouth-opening Training With Follow-up Calls|"Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.~The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence."
11353535|NCT03875118|FG001|Participant Flow|Mouth-opening Training Without Follow-up Calls|"Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.~The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks."
11353536|NCT03875118|OG000|Outcome|Mouth-opening Training With Follow-up Calls|"Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.~The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence."
11353537|NCT03875118|OG001|Outcome|Mouth-opening Training Without Follow-up Calls|"Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.~The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks."
11353538|NCT03875118|EG000|Reported Event|The Intervention Group|"Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.~The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence."
11353539|NCT03875118|EG001|Reported Event|The Control Group|"Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.~The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks."
10851308|NCT00305695|OG001|Outcome|Arm II (Clinical Observation)|Patients are observed for 18 months after surgery.
11231458|NCT02413008|FG000|Participant Flow|0.005% Estriol Vaginal Gel|Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
11231459|NCT02413008|FG001|Participant Flow|Placebo Vaginal Gel|"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration~Placebo"
11231460|NCT02413008|OG000|Outcome|0.005% Estriol Vaginal Gel|Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
11231461|NCT02413008|OG001|Outcome|Placebo Vaginal Gel|"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration~Placebo"
11231462|NCT02413008|OG000|Outcome|0.005% Estriol Vaginal Gel|"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration~estriol: 0.005% estriol vaginal gel"
11231463|NCT02413008|OG001|Outcome|Placebo Vaginal Gel|"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration~Placebo: placebo vaginal gel"
11231464|NCT02413008|OG000|Outcome|0.005% Estriol Vaginal Gel|"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration~estriol"
11231465|NCT02413008|EG000|Reported Event|0.005% Estriol Vaginal Gel|Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
11231466|NCT02413008|EG001|Reported Event|Placebo Vaginal Gel|"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration~Placebo"
11231467|NCT02413034|BG000|Baseline|Control Group|No antibiotic prophylaxis
11231468|NCT02413034|BG001|Baseline|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
11231469|NCT02413034|BG002|Baseline|Total|Total of all reporting groups
11231470|NCT02413034|FG000|Participant Flow|Control Group|No antibiotic prophylaxis
11231471|NCT02413034|FG001|Participant Flow|Study Group|Cefazolin: Cefazolin (vancomycin in the case of allergy to cefazolin)
11231472|NCT02413034|OG000|Outcome|Control Group|No antibiotic prophylaxis
11231473|NCT02413034|OG001|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
11231474|NCT02413034|EG000|Reported Event|Control Group|No antibiotic prophylaxis
11231475|NCT02413034|EG001|Reported Event|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
11231476|NCT02413151|BG000|Baseline|Exercise Training Program|The exercise sessions will be hospital-based, 3times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods. The patient will warmup for 10 minutes at 50% to 60% of HRpeak from CPET, before walking to four 4 minutes intervals at 90 to 95% of HRpeak.
11231477|NCT02413151|BG001|Baseline|Control|"Regular lifestyle~Cardiac resynchronization therapy (CRT): Implantation will be performed according to standard techniques of biventricular pacing. The CRT includes a generator and three leads, used to correct ventricular dyssynchrony."
11231478|NCT02413151|BG002|Baseline|Total|Total of all reporting groups
11231479|NCT02413151|FG000|Participant Flow|Exercise Training Program|The exercise sessions will be hospital-based, 3times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods. The patient will warmup for 10 minutes at 50% to 60% of HRpeak from CPET, before walking to four 4 minutes intervals at 90 to 95% of HRpeak.
11231480|NCT02413151|FG001|Participant Flow|Control|"Regular lifestyle~Cardiac resynchronization therapy (CRT): Implantation will be performed according to standard techniques of biventricular pacing. The CRT includes a generator and three leads, used to correct ventricular dyssynchrony."
11231481|NCT02413151|OG000|Outcome|Exercise Training Program|"The exercise sessions will be hospital-based, 3times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods.~Exercise training program: The exercise sessions will be hospital-based, 3 times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods. The patient will warmup for 10 minutes at 50% to 60% of HRpeak from CPET, before walking to four 4 minutes intervals at 90 to 95% of"
11231482|NCT02413151|OG001|Outcome|Control|"Regular lifestyle~Cardiac resynchronization therapy (CRT): Implantation will be performed according to standard techniques of biventricular pacing. The CRT includes a generator and three leads, used to correct ventricular dyssynchrony."
11231483|NCT02413151|OG000|Outcome|Exercise Training Program|The exercise sessions will be hospital-based, 3times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods. The patient will warmup for 10 minutes at 50% to 60% of HRpeak from CPET, before walking to four 4 minutes intervals at 90 to 95% of HRpeak.
11231484|NCT02413151|EG000|Reported Event|Exercise Training Program|"The exercise sessions will be hospital-based, 3times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods.~Exercise training program: The exercise sessions will be hospital-based, 3 times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods. The patient will warmup for 10 minutes at 50% to 60% of HRpeak from CPET, before walking to four 4 minutes intervals at 90 to 95% of"
11231485|NCT02413151|EG001|Reported Event|Control|"Regular lifestyle~Cardiac resynchronization therapy (CRT): Implantation will be performed according to standard techniques of biventricular pacing. The CRT includes a generator and three leads, used to correct ventricular dyssynchrony."
11231486|NCT02413190|BG000|Baseline|FSHD|94 subjects with genetically confirmed FSHD1
11231487|NCT02413190|FG000|Participant Flow|FSHD|94 subjects
11231488|NCT02413190|OG000|Outcome|FSHD|94 subjects with genetically confirmed FSHD1
11231489|NCT02413190|EG000|Reported Event|FSHD|All subjects with a confirmed FSHD allele
11231490|NCT02413203|BG000|Baseline|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
11231491|NCT02413203|BG001|Baseline|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
11231492|NCT02413203|BG002|Baseline|Total|Total of all reporting groups
11231493|NCT02413203|FG000|Participant Flow|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
11231494|NCT02413203|FG001|Participant Flow|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
11231495|NCT02413203|OG000|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
11231496|NCT02413203|OG001|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
11231497|NCT02413203|EG000|Reported Event|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
11231498|NCT02413203|EG001|Reported Event|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
11231499|NCT02413229|BG000|Baseline|DSXS1411 5 Min|"DSXS applied once a day for a total of 28 days for duration of 5 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231500|NCT02413229|BG001|Baseline|Placebo 5 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231501|NCT02413229|BG002|Baseline|DSXS1411 10 Min|"DSXS applied once a day for a total of 28 days for duration of 10 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231502|NCT02413229|BG003|Baseline|Placebo 10 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231503|NCT02413229|BG004|Baseline|DSXS1411 15 Min|"DSXS applied once a day for a total of 28 days for duration of 15 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231504|NCT02413229|BG005|Baseline|Placebo 15 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231505|NCT02413229|BG006|Baseline|DSXS1411 30 Min|"DSXS applied once a day for a total of 28 days for duration of 30 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231506|NCT02413229|BG007|Baseline|Placebo 30 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231507|NCT02413229|BG008|Baseline|Total|Total of all reporting groups
11231508|NCT02413229|FG000|Participant Flow|DSXS1411 5 Min|"DSXS applied once a day for a total of 28 days for duration of 5 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231509|NCT02413229|FG001|Participant Flow|Placebo 5 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231510|NCT02413229|FG002|Participant Flow|DSXS1411 10 Min|"DSXS applied once a day for a total of 28 days for duration of 10 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231511|NCT02413229|FG003|Participant Flow|Placebo 10 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231512|NCT02413229|FG004|Participant Flow|DSXS1411 15 Min|"DSXS applied once a day for a total of 28 days for duration of 15 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231513|NCT02413229|FG005|Participant Flow|Placebo 15 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231514|NCT02413229|FG006|Participant Flow|DSXS1411 30 Min|"DSXS applied once a day for a total of 28 days for duration of 30 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231515|NCT02413229|FG007|Participant Flow|Placebo 30 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231516|NCT02413229|OG000|Outcome|DSXS1411 5 Min|"DSXS applied once a day for a total of 28 days for duration of 5 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231517|NCT02413229|OG001|Outcome|Placebo 5 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231518|NCT02413229|OG002|Outcome|DSXS1411 10 Min|"DSXS applied once a day for a total of 28 days for duration of 10 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231519|NCT02413229|OG003|Outcome|Placebo 10 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231520|NCT02413229|OG004|Outcome|DSXS1411 15 Min|"DSXS applied once a day for a total of 28 days for duration of 15 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231521|NCT02413229|OG005|Outcome|Placebo 15 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231522|NCT02413229|OG006|Outcome|DSXS1411 30 Min|"DSXS applied once a day for a total of 28 days for duration of 30 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231523|NCT02413229|OG007|Outcome|Placebo 30 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231524|NCT02413229|EG000|Reported Event|DSXS1411 5 Min|"DSXS applied once a day for a total of 28 days for duration of 5 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231525|NCT02413229|EG001|Reported Event|Placebo 5 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231526|NCT02413229|EG002|Reported Event|DSXS1411 10 Min|"DSXS applied once a day for a total of 28 days for duration of 10 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231527|NCT02413229|EG003|Reported Event|Placebo 10 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231528|NCT02413229|EG004|Reported Event|DSXS1411 15 Min|"DSXS applied once a day for a total of 28 days for duration of 15 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231529|NCT02413229|EG005|Reported Event|Placebo 15 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231530|NCT02413229|EG006|Reported Event|DSXS1411 30 Min|"DSXS applied once a day for a total of 28 days for duration of 30 minutes.~DSXS1411: DSXS (Taro Pharmaceuticals Inc.)"
11231531|NCT02413229|EG007|Reported Event|Placebo 30 Min|"Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.~Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)"
11231532|NCT02413255|BG000|Baseline|Part 1 Cohort 1-9: Placebo|TAK-020 placebo-matching solution, orally, once on Day 1.
11231533|NCT02413255|BG001|Baseline|Part 1 Cohort 1: TAK-020 0.1 mg|TAK-020 0.1 milligram (mg), solution, orally once on Day 1.
11231534|NCT02413255|BG002|Baseline|Part 1 Cohort 2: TAK-020 0.5 mg|TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.
11231535|NCT02413255|BG003|Baseline|Part 1 Cohort 3: TAK-020 2.5 mg|TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.
11231536|NCT02413255|BG004|Baseline|Part 1 Cohort 4: TAK-020 4.4 mg|TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.
11231537|NCT02413255|BG005|Baseline|Part 1 Cohort 5: TAK-020 8.8 mg|TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.
11231538|NCT02413255|BG006|Baseline|Part 1 Cohort 6: TAK-020 17.5 mg|TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.
11231539|NCT02413255|BG007|Baseline|Part 1 Cohort 7: TAK-020 35 mg|TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.
11231540|NCT02413255|BG008|Baseline|Part 1 Cohort 8: TAK-020 70 mg|TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.
11231541|NCT02413255|BG009|Baseline|Part 1 Cohort 9: TAK-020 105 mg|TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
11353540|NCT03873987|BG000|Baseline|Current Formulation of Oritavancin|"Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.~Current Formulation of Oritavancin: Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)"
11353541|NCT03873987|BG001|Baseline|New Formulation of Oritavancin|"A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.~New Formulation of Oritavancin: New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)"
11353542|NCT03873987|BG002|Baseline|Total|Total of all reporting groups
11353543|NCT03873987|FG000|Participant Flow|Current Formulation of Oritavancin|"Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.~Current Formulation of Oritavancin: Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)"
11353544|NCT03873987|FG001|Participant Flow|New Formulation of Oritavancin|"A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.~New Formulation of Oritavancin: New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)"
11353545|NCT03873987|OG000|Outcome|Orbactiv|Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Orbactiv vials were reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.
11353546|NCT03873987|OG001|Outcome|Kimrysa|A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.
11353547|NCT03873987|OG001|Outcome|Kimyrsa|A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.
11353548|NCT03873987|EG000|Reported Event|Orbactiv|Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Orbactiv vials were reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.
11353549|NCT03873987|EG001|Reported Event|Kimrysa|A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.
11357264|NCT03762213|OG000|Outcome|Oculus GO VR HMD, Application Happy Place (© Mimerse)|"Oculus GO is a stand-alone, consumer-grade, virtual reality head-mounted display (HMD). The HMD is placed on the head of the user blocking off the surrounding environment. The visuals and audio are relayed through the HMD in a virtual space.Happy Place (© Mimerse) is a publicly available application with an explicit intent to be used for chronic pain patients. It has the critical elements of VR, namely immersion and interactivity.~Immersion: The scene is a serene lakeside campground with guided relaxation and soothing music. The application intends to promote positive effects such as calmness and feeling of wonder.~Interactivity: Happy Place uses an innovative 'gaze-based interaction' with the virtual world. Around 50 'gaze objects' are placed around the scene and gazing at them would trigger an event.~The entire duration of the experience will be kept at 10 minutes.~Oculus GO VR HMD, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages)."
11357265|NCT03762213|OG001|Outcome|iPad, Application Happy Place (© Mimerse)|"An iPad with earphones (Apple Inc. Cupertino CA) will be used for controls. The participants in control group will watch the same content for the same duration on an iPad screen (flat version of Happy Place). This experience will be different from the intervention group in two ways: first, lack of an immersive environment, and second, lack of interactivity with the environment.~iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages)."
11353550|NCT03870893|BG000|Baseline|Intervention Group|Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
11353551|NCT03870893|BG001|Baseline|Control Group|No intervention
11353552|NCT03870893|BG002|Baseline|Total|Total of all reporting groups
11353553|NCT03870893|FG000|Participant Flow|Intervention Group|Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
11168062|NCT01984229|FG000|Participant Flow|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40 milligrams (mg) single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg twice daily (BID) oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
11168063|NCT01984229|FG001|Participant Flow|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
11353554|NCT03870893|FG001|Participant Flow|Control Group|No intervention.
11353555|NCT03870893|OG000|Outcome|Intervention Group|Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
11353556|NCT03870893|OG001|Outcome|Control Group|No intervention
11353557|NCT03870893|OG000|Outcome|Intervention Group|Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions) in addition to conventional physiotherapy.
11353558|NCT03870893|EG000|Reported Event|Intervention Group|Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions) in addition to conventional physiotherapy.
11168064|NCT01984229|OG000|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
11168065|NCT01984229|OG001|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
11168066|NCT01984229|OG000|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
11353559|NCT03870893|EG001|Reported Event|Control Group|No intervention.
11353560|NCT03887299|BG000|Baseline|Standard Wound Care|"Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.~Standard Wound Care: Wound care will be administered as standard protocol in our institution"
11353561|NCT03887299|BG001|Baseline|CHG Wound Care|"ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.~ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7"
11353562|NCT03887299|BG002|Baseline|Total|Total of all reporting groups
11353563|NCT03887299|FG000|Participant Flow|Standard Wound Care|"Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.~Standard Wound Care: Wound care will be administered as standard protocol in our institution"
11353564|NCT03887299|FG001|Participant Flow|CHG Wound Care|"ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.~ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7"
11353565|NCT03887299|OG000|Outcome|Standard Wound Care|"Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.~Standard Wound Care: Wound care will be administered as standard protocol in our institution"
11353566|NCT03887299|OG001|Outcome|CHG Wound Care|"ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.~ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7"
11353567|NCT03887299|EG000|Reported Event|Standard Wound Care|"Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.~Standard Wound Care: Wound care will be administered as standard protocol in our institution"
11353568|NCT03887299|EG001|Reported Event|CHG Wound Care|"ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.~ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7"
11353569|NCT03878758|BG000|Baseline|All Study Participants|Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G or Artsana Insupen Extr3me 3.5mm x 34G or Simple Diagnostics Comfort EZ™ 4mm x 33G
11353570|NCT03878758|FG000|Participant Flow|All Study Participants|Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G or Artsana Insupen Extr3me 3.5mm x 34G or Simple Diagnostics Comfort EZ™ 4mm x 33G
11353571|NCT03878758|OG000|Outcome|BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me|"Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2~BD Nano™ PRO: Insulin Pen needle~34G Artsana Insupen Extr3me: Insulin Pen Needle"
11353572|NCT03878758|OG001|Outcome|BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me|"Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2~BD Nano™ PRO: Insulin Pen needle~33G Artsana Insupen Extr3me: Insulin Pen Needle"
11353573|NCT03878758|OG002|Outcome|BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™|"Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2~BD Nano™ PRO: Insulin Pen needle~Simple Diagnostics Comfort EZ™: Insulin Pen Needle"
11353574|NCT03878758|OG000|Outcome|BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me|"Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2~BD Nano™ PRO: Insulin Pen needle~33G Artsana Insupen Extr3me: Insulin Pen Needle"
11353575|NCT03878758|OG001|Outcome|BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me|"Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2~BD Nano™ PRO: Insulin Pen needle~34G Artsana Insupen Extr3me: Insulin Pen Needle"
11353576|NCT03878758|OG000|Outcome|All Study Participants|Subjects are to perform 6 pairs if injections. Each Pair consists of BD Nano and one comparator. Each comparator was used twice
11353577|NCT03878758|OG000|Outcome|All Study Participants|Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G or Artsana Insupen Extr3me 3.5mm x 34G or Simple Diagnostics Comfort EZ™ 4mm x 33G
11353578|NCT03878758|EG000|Reported Event|BD Nano™ PRO Pen Needle|Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs a competitor product.
11353579|NCT03878758|EG001|Reported Event|34G Artsana Insupen Extr3me|Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs a competitor product.
11353580|NCT03878758|EG002|Reported Event|33G Artsana Insupen Extr3me|Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs a competitor product.
11168067|NCT01984229|OG001|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
11353581|NCT03878758|EG003|Reported Event|Simple Diagnostics Comfort EZ™|Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs a competitor product.
11353582|NCT03849300|BG000|Baseline|Control Group|No exercise intervention
11353583|NCT03849300|BG001|Baseline|Aquatic Walking Exercise Group 1|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353584|NCT03849300|BG002|Baseline|Aquatic Walking Exercise Group 2|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353585|NCT03849300|BG003|Baseline|Land-based Walking Group|"The land-based walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of low-intensity forward, backward, and lateral side-stepping movements on flat group. The remaining 30 minutes included treadmill walking exercise.~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353586|NCT03849300|BG004|Baseline|Total|Total of all reporting groups
11168068|NCT01984229|EG000|Reported Event|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
11353587|NCT03849300|FG000|Participant Flow|Control Group|No exercise intervention
11353588|NCT03849300|FG001|Participant Flow|Aquatic Walking Exercise Group 1|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353589|NCT03849300|FG002|Participant Flow|Aquatic Walking Exercise Group 2|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353590|NCT03849300|FG003|Participant Flow|Land-based Walking Exercise Group|"The land-based walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of low-intensity forward, backward, and lateral side-stepping movements on flat group. The remaining 30 minutes included treadmill walking exercise.~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353591|NCT03849300|OG000|Outcome|Control Group|No exercise intervention
11353592|NCT03849300|OG001|Outcome|Aquatic Walking Exercise Group 1|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353593|NCT03849300|OG002|Outcome|Aquatic Walking Exercise Group 2|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353594|NCT03849300|OG003|Outcome|Land-based Walking Exercise Group|"The land-based walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of low-intensity forward, backward, and lateral side-stepping movements on flat group. The remaining 30 minutes included treadmill walking exercise.~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353595|NCT03849300|OG000|Outcome|Aquatic Walking Exercise Group 2|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353596|NCT03849300|OG001|Outcome|Land-based Exercise Walking Group|"The land-based walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of low-intensity forward, backward, and lateral side-stepping movements on flat group. The remaining 30 minutes included treadmill walking exercise.~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353597|NCT03849300|EG000|Reported Event|Control Group|No exercise intervention
10851309|NCT00305695|EG000|Reported Event|Arm I (Zoledroic Acid)|"Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.~Laboratory Biomarker Analysis: Correlative studies~Zoledronic Acid: Given IV"
11353598|NCT03849300|EG001|Reported Event|Aquatic Walking Exercise Group 1|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353599|NCT03849300|EG002|Reported Event|Aquatic Walking Exercise Group 2|"The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking exercise (forward, backward).~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353600|NCT03849300|EG003|Reported Event|Land-based Walking Group|"The land-based walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks.~The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of low-intensity forward, backward, and lateral side-stepping movements on flat group. The remaining 30 minutes included treadmill walking exercise.~The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity."
11353601|NCT03887429|BG000|Baseline|SXC-2023 200 mg Followed by Placebo|"SXC-2023 200mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.~SXC-2023: SXC-2023 oral capsules~Placebos: Matching Placebo oral capsules"
11353602|NCT03887429|BG001|Baseline|Placebo Followed by SXC-2023 200 mg|"Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 200mg dosed once daily for 5 days.~SXC-2023: SXC-2023 oral capsules~Placebos: Matching Placebo oral capsules"
11353603|NCT03887429|BG002|Baseline|SXC-2023 800 mg Followed by Placebo|"SXC-2023 800mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.~SXC-2023: SXC-2023 oral capsules~Placebos: Matching Placebo oral capsules"
11353604|NCT03887429|BG003|Baseline|Placebo Followed by SXC-2023 800 mg|"Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 800mg dosed once daily for 5 days.~SXC-2023: SXC-2023 oral capsules~Placebos: Matching Placebo oral capsules"
11353605|NCT03887429|BG004|Baseline|Total|Total of all reporting groups
11353606|NCT03887429|FG000|Participant Flow|SXC-2023 200 mg Followed by Placebo|"SXC-2023 200mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.~SXC-2023: SXC-2023 oral capsules~Placebos: Matching Placebo oral capsules"
11353607|NCT03887429|FG001|Participant Flow|Placebo Followed by SXC-2023 200 mg|"Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 200mg dosed once daily for 5 days.~SXC-2023: SXC-2023 oral capsules~Placebos: Matching Placebo oral capsules"
11353608|NCT03887429|FG002|Participant Flow|SXC-2023 800 mg Followed by Placebo|"SXC-2023 800mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.~SXC-2023: SXC-2023 oral capsules~Placebos: Matching Placebo oral capsules"
11353609|NCT03887429|FG003|Participant Flow|Placebo Followed by SXC-2023 800 mg|"Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 800mg dosed once daily for 5 days.~SXC-2023: SXC-2023 oral capsules~Placebos: Matching Placebo oral capsules"
11168069|NCT01984229|EG001|Reported Event|Cohort A: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
11168070|NCT01984229|EG002|Reported Event|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
11353610|NCT03887429|OG000|Outcome|During 200 mg SXC-2023 Treatment|AEs observed during treatment with SXC-2023 200 mg.
11353611|NCT03887429|OG001|Outcome|During 800 mg SXC-2023 Treatment|AEs observed during treatment with SXC-2023 800 mg.
11353612|NCT03887429|OG002|Outcome|During Placebo Treatment|AEs observed during treatment with Placebo.
11353613|NCT03887429|OG000|Outcome|SXC-2023 200mg|Change in subjects treated with 200 mg SXC-2023 for 5 days.
11353614|NCT03887429|OG001|Outcome|SXC-2023 800mg|Change in subjects treated with 800 mg SXC-2023 for 5 days.
11353615|NCT03887429|OG002|Outcome|Placebo|Change in subjects treated with Placebo for 5 days.
11353616|NCT03887429|OG000|Outcome|200 mg SXC-2023 or Placebo QD|Change in Positive and Negative affect in subjects treated with 200 mg SXC-2023 or placebo for 5 days.
11353617|NCT03887429|OG001|Outcome|800 mg SXC-2023 or Placebo QD|Change in Positive and Negative affect in subjects treated with 800 mg SXC-2023 or placebo for 5 days.
11353618|NCT03887429|OG000|Outcome|200 mg SXC-2023 or Placebo QD|Change in subjects treated with 200 mg SXC-2023 or placebo for 5 days.
11353619|NCT03887429|OG001|Outcome|800 mg SXC-2023 or Placebo QD|Change in subjects treated with 800 mg SXC-2023 or placebo for 5 days.
11353620|NCT03887429|EG000|Reported Event|During 200 mg SXC-2023 Treatment|AEs observed during treatment with SXC-2023 200 mg.
11353621|NCT03887429|EG001|Reported Event|During 800 mg SXC-2023 Treatment|AEs observed during treatment with SXC-2023 800 mg.
11353622|NCT03887429|EG002|Reported Event|During Placebo Treatment|AEs observed during treatment with Placebo.
11353623|NCT03886701|BG000|Baseline|Study Particpants|Eleven healthy volunteers enrolled into the study.
11353624|NCT03886701|FG000|Participant Flow|Study Particpants|Eleven healthy volunteers enrolled into the study. For period 1 (study days 1-4), participants will be given doravirine 100mg oral tablets dosed twice-daily on study days 1-4. For period 2 (study days 7-21), oral 100mg doravirine will be dosed twice-daily. Weight-based rifapentine and isoniazid (as recommended by the CDC) will be given orally once-weekly on study days 7, 14, and 21.
11353625|NCT03886701|OG000|Outcome|Period 1|"DOR twice-daily alone (Study days 1-4)~Doravirine (DOR): Non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.~Rifapentine (RPT): Rifamycin anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.~Isoniazid (INH): Anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection."
11353626|NCT03886701|OG001|Outcome|Period 2|DOR twice-daily with RPT/INH once-weekly (Study days 7-21)
11353627|NCT03886701|EG000|Reported Event|Period 1|"DOR twice-daily alone (Study days 1-4)~Doravirine (DOR): Non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.~Rifapentine (RPT): Rifamycin anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.~Isoniazid (INH): Anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection."
11353628|NCT03886701|EG001|Reported Event|Period 2|DOR twice-daily with RPT/INH once-weekly (Study days 7-21)
11353629|NCT03883113|BG000|Baseline|MVA-NP+M1 & H3N2 Challenge Virus|"Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml)~MVA-NP+M1: Trial Vaccine~H3N2 (A/Belgium/2417/2015): Challenge Agent"
11353630|NCT03883113|BG001|Baseline|Saline Placebo & H3N2 Challenge Virus|"Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml)~Saline: Sodium Chloride Placebo~H3N2 (A/Belgium/2417/2015): Challenge Agent"
11353631|NCT03883113|BG002|Baseline|Total|Total of all reporting groups
11353632|NCT03883113|FG000|Participant Flow|MVA-NP+M1 & H3N2 Challenge Virus|"Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml)~MVA-NP+M1: Trial Vaccine~H3N2 (A/Belgium/2417/2015): Challenge Agent"
11168071|NCT01984229|EG003|Reported Event|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
11353633|NCT03883113|FG001|Participant Flow|Saline Placebo & H3N2 Challenge Virus|"Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml)~Saline: Sodium Chloride Placebo~H3N2 (A/Belgium/2417/2015): Challenge Agent"
11353634|NCT03883113|OG000|Outcome|MVA-NP+M1 (ITT)|Intention-to-treat (the actually challenged with the virus)
11353635|NCT03883113|OG001|Outcome|Placebo (ITT)|Intention-to-treat (the actually challenged with the virus)
11353636|NCT03883113|OG002|Outcome|MVA-NP+M1 (PP)|Per protocol analysis set
11353637|NCT03883113|OG003|Outcome|Placebo (PP)|Per protocol analysis set
11353638|NCT03883113|OG004|Outcome|MVA-NP+M1 (Challenge)|Safety Analysis Set (challenged participants)
11353639|NCT03883113|OG005|Outcome|Placebo (Challenge)|Safety Analysis Set (challenged participants)
11353640|NCT03883113|OG000|Outcome|MVA-NP+M1 (ITT)|Intention-to-treat
11353641|NCT03883113|OG001|Outcome|Placebo (ITT)|Intention-to-treat
11353642|NCT03883113|OG000|Outcome|MVA-NP+M1 (ITT) Successful Attack|Subset of participants who received MVA-NP+M1 and with a successful attack
11353643|NCT03883113|OG001|Outcome|Placebo (ITT) Successful Attack|Subset of participants who received Placebo and with a successful attack
11353644|NCT03883113|OG000|Outcome|MVA-NP+M1|"Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml)~MVA-NP+M1: Trial Vaccine"
11353645|NCT03883113|OG001|Outcome|Saline Placebo|"Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml)~Saline: Sodium Chloride Placebo"
11353646|NCT03883113|OG000|Outcome|MVA-NP+M1 (Challenge)|Safety Analysis Set (challenged participants)
11353647|NCT03883113|OG001|Outcome|Placebo (Challenge)|Safety Analysis Set (challenged participants)
11353648|NCT03883113|EG000|Reported Event|MVA-NP+M1 (Vaccination Phase)|"Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.);~MVA-NP+M1: Trial Vaccine"
11353649|NCT03883113|EG001|Reported Event|Saline Placebo (Vaccination Phase)|"Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%);~Saline: Sodium Chloride Placebo"
11353650|NCT03883113|EG002|Reported Event|MVA-NP+M1 (Challenge Phase)|"Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.);~MVA-NP+M1: Trial Vaccine~Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml)"
11353651|NCT03883113|EG003|Reported Event|Saline Placebo (Challenge Phase)|"Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%);~Saline: Sodium Chloride Placebo~Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml)"
11353652|NCT03880227|BG000|Baseline|Anodal/Sham Stimulation tDCS to rTPJ|"Within subject design - sham and anodal tDCS to the rTPJ followed by behavioral testing~Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention Sham tDCS: sham tDCS with behavioral tasks to assess visual attention"
11353653|NCT03880227|BG001|Baseline|Anodal/Sham Stimulation tDCS to dmPFC|"Within subject design - sham and anodal tDCS to the dmPFC followed by behavioral testing~Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention Sham tDCS: sham tDCS with behavioral tasks to assess visual attention"
11353654|NCT03880227|BG002|Baseline|Total|Total of all reporting groups
11231542|NCT02413255|BG010|Baseline|Part 2 Cohort 1-6: Placebo|TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9.
11231543|NCT02413255|BG011|Baseline|Part 2 Cohort 1: TAK-020 3.75 mg|TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.
11231544|NCT02413255|BG012|Baseline|Part 2 Cohort 2: TAK-020 5.75 mg|TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.
11231545|NCT02413255|BG013|Baseline|Part 2 Cohort 3: TAK-020 13 mg|TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.
11231546|NCT02413255|BG014|Baseline|Part 2 Cohort 4: TAK-020 25 mg|TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.
11231547|NCT02413255|BG015|Baseline|Part 2 Cohort 5: TAK-020 45 mg|TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.
11231548|NCT02413255|BG016|Baseline|Part 2 Cohort 6: TAK-020 60 mg|TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.
11231549|NCT02413255|BG017|Baseline|Total|Total of all reporting groups
11231550|NCT02413255|FG000|Participant Flow|Part 1 Cohort 1-9: Placebo|TAK-020 placebo-matching solution, orally, once on Day 1.
11231551|NCT02413255|FG001|Participant Flow|Part 1 Cohort 1: TAK-020 0.1 mg|TAK-020 0.1 milligram (mg), solution, orally once on Day 1.
11231552|NCT02413255|FG002|Participant Flow|Part 1 Cohort 2: TAK-020 0.5 mg|TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.
11231553|NCT02413255|FG003|Participant Flow|Part 1 Cohort 3: TAK-020 2.5 mg|TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.
11231554|NCT02413255|FG004|Participant Flow|Part 1 Cohort 4: TAK-020 4.4 mg|TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.
11231555|NCT02413255|FG005|Participant Flow|Part 1 Cohort 5: TAK-020 8.8 mg|TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.
11231556|NCT02413255|FG006|Participant Flow|Part 1 Cohort 6: TAK-020 17.5 mg|TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.
11231557|NCT02413255|FG007|Participant Flow|Part 1 Cohort 7: TAK-020 35 mg|TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.
11231558|NCT02413255|FG008|Participant Flow|Part 1 Cohort 8: TAK-020 70 mg|TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.
11231559|NCT02413255|FG009|Participant Flow|Part 1 Cohort 9: TAK-020 105 mg|TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
11231560|NCT02413255|FG010|Participant Flow|Part 2 Cohort 1-6: Placebo|TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9.
11231561|NCT02413255|FG011|Participant Flow|Part 2 Cohort 1: TAK-020 3.75 mg|TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.
11231562|NCT02413255|FG012|Participant Flow|Part 2 Cohort 2: TAK-020 5.75 mg|TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.
11231563|NCT02413255|FG013|Participant Flow|Part 2 Cohort 3: TAK-020 13 mg|TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.
11231564|NCT02413255|FG014|Participant Flow|Part 2 Cohort 4: TAK-020 25 mg|TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.
11231565|NCT02413255|FG015|Participant Flow|Part 2 Cohort 5: TAK-020 45 mg|TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.
11231566|NCT02413255|FG016|Participant Flow|Part 2 Cohort 6: TAK-020 60 mg|TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.
11231567|NCT02413255|OG000|Outcome|Part 1 Cohort 1-9: Placebo|TAK-020 placebo-matching solution, orally, once on Day 1.
11231568|NCT02413255|OG001|Outcome|Part 1 Cohort 1: TAK-020 0.1 mg|TAK-020 0.1 milligram (mg), solution, orally once on Day 1.
11231569|NCT02413255|OG002|Outcome|Part 1 Cohort 2: TAK-020 0.5 mg|TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.
11231570|NCT02413255|OG003|Outcome|Part 1 Cohort 3: TAK-020 2.5 mg|TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.
11231571|NCT02413255|OG004|Outcome|Part 1 Cohort 4: TAK-020 4.4 mg|TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.
11231572|NCT02413255|OG005|Outcome|Part 1 Cohort 5: TAK-020 8.8 mg|TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.
11231573|NCT02413255|OG006|Outcome|Part 1 Cohort 6: TAK-020 17.5 mg|TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.
11231574|NCT02413255|OG007|Outcome|Part 1 Cohort 7: TAK-020 35 mg|TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.
11231575|NCT02413255|OG008|Outcome|Part 1 Cohort 8: TAK-020 70 mg|TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.
11353655|NCT03880227|FG000|Participant Flow|Anodal Followed by Sham Stimulation tDCS to rTPJ|"Active stimulation tDCS over the rTPJ followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)~After 1 week washout, sham stimulation tDCS to the rTPJ followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes"
11353656|NCT03880227|FG001|Participant Flow|Anodal Followed by Sham Stimulation tDCS to dmPFC|"Active stimulation tDCS over the dmPFC followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)~After 1 week washout, sham stimulation tDCS to the dmPFC followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes"
11353657|NCT03880227|FG002|Participant Flow|Sham Followed by Anodal Stimulation tDCS to rTPJ|"Sham stimulation tDCS to the rTPJ followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes~After 1 week delay, Active stimulation tDCS over the rTPJ followed by behavioral testing.~Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)"
11353658|NCT03880227|FG003|Participant Flow|Sham Followed by Anodal Stimulation tDCS to dmPFC|"Sham stimulation tDCS to the dmPFC followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes~After 1 week delay, Active stimulation tDCS over the dmPFC followed by behavioral testing.~Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)"
11353659|NCT03880227|OG000|Outcome|Anodal Stimulation tDCS to rTPJ|"anodal tDCS to the rTPJ followed by behavioral testing~Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention"
11353660|NCT03880227|OG001|Outcome|Sham tDCS to rTPJ|"sham tDCS to the rTPJ followed by behavioral testing~Sham tDCS: sham tDCS with behavioral tasks to assess visual attention"
11353661|NCT03880227|OG002|Outcome|Anodal Stimulation tDCS to dmPFC|"anodal tDCS to the dmPFC followed by behavioral testing~Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention"
11353662|NCT03880227|OG003|Outcome|Sham tDCS to dmPFC|"sham tDCS to the dmPFC followed by behavioral testing~Sham tDCS: sham tDCS with behavioral tasks to assess visual attention"
11353663|NCT03880227|EG000|Reported Event|Anodal Stimulation tDCS to rTPJ|anodal tDCS to the rTPJ followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
11353664|NCT03880227|EG001|Reported Event|Sham tDCS to rTPJ|sham tDCS to the rTPJ followed by behavioral testing Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
11353665|NCT03880227|EG002|Reported Event|Anodal Stimulation tDCS to dmPFC|anodal tDCS to the dmPFC followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
11353666|NCT03880227|EG003|Reported Event|Sham tDCS to dmPFC|sham tDCS to the dmPFC followed by behavioral testing Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
11353667|NCT03876743|BG000|Baseline|Group 1 (Filled)-Knee Arthroscopy|"Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.~Group 1-Knee Arthroscopy: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected."
11353668|NCT03876743|BG001|Baseline|Group 2 (as Needed)-Knee Arthroscopy|"Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.~Group 2-Knee Arthroscopy: Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed."
11353669|NCT03876743|BG002|Baseline|Group 1 (60)-ACL Reconstruction|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11353670|NCT03876743|BG003|Baseline|Group 2 (30)-ACL Reconstruction|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11353671|NCT03876743|BG004|Baseline|Total|Total of all reporting groups
11353672|NCT03876743|FG000|Participant Flow|Group 1 (Filled)-Knee Arthroscopy|"Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.~Group 1-Knee Arthroscopy: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected."
11353673|NCT03876743|FG001|Participant Flow|Group 2 (as Needed)-Knee Arthroscopy|"Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.~Group 2-Knee Arthroscopy: Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed."
11353674|NCT03876743|FG002|Participant Flow|Group 1 (60)-ACL Reconstruction|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11353675|NCT03876743|FG003|Participant Flow|Group 2(30)-ACL Reconstruction|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11353676|NCT03876743|OG000|Outcome|Group 1-Knee Arthroscopy|"Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.~Group 1-Knee Arthroscopy: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected."
11353677|NCT03876743|OG001|Outcome|Group 2-Knee Arthroscopy|"Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.~Group 2-Knee Arthroscopy: Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed."
11353678|NCT03876743|OG002|Outcome|Group 1-ACL Reconstruction|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11353679|NCT03876743|OG003|Outcome|Group 2-ACL Reconstruction|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11353680|NCT03876743|OG000|Outcome|Group 1 (Filled)-Knee Arthroscopy|"Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.~Group 1-Knee Arthroscopy: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected."
11353681|NCT03876743|OG001|Outcome|Group 2 (as Needed)-Knee Arthroscopy|"Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.~Group 2-Knee Arthroscopy: Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed."
11353682|NCT03876743|OG002|Outcome|Group 1 (60)-ACL Reconstruction|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11353683|NCT03876743|OG003|Outcome|Group 2(30)-ACL Reconstruction|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11353684|NCT03876743|EG000|Reported Event|Group 1-Knee Arthroscopy|"Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.~Group 1-Knee Arthroscopy: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected."
11353685|NCT03876743|EG001|Reported Event|Group 2-Knee Arthroscopy|"Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.~Group 2-Knee Arthroscopy: Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed."
11353686|NCT03876743|EG002|Reported Event|Group 1-ACL Reconstruction|"Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens."
11353687|NCT03876743|EG003|Reported Event|Group 2-ACL Reconstruction|"Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.~Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens."
11353688|NCT03885934|BG000|Baseline|V114, Schedule A: Participants 7-11 Months|Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
11353689|NCT03885934|BG001|Baseline|Prevnar 13®, Schedule A: Participants 7-11 Months|Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
11353690|NCT03885934|BG002|Baseline|V114, Schedule B: Participants 12-23 Months|Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
11353691|NCT03885934|BG003|Baseline|Prevnar 13®, Schedule B: Participants 12-23 Months|Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
11353692|NCT03885934|BG004|Baseline|V114, Schedule C: Participants 2-17 Years|Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
11353693|NCT03885934|BG005|Baseline|Prevnar 13®, Schedule C: Participants 2-17 Years|Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
11353694|NCT03885934|BG006|Baseline|Total|Total of all reporting groups
11353695|NCT03885934|FG000|Participant Flow|V114, Schedule A: Participants 7-11 Months|Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
11353696|NCT03885934|FG001|Participant Flow|Prevnar 13®, Schedule A: Participants 7-11 Months|Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
11353697|NCT03885934|FG002|Participant Flow|V114, Schedule B: Participants 12-23 Months|Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
11353698|NCT03885934|FG003|Participant Flow|Prevnar 13®, Schedule B: Participants 12-23 Months|Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
11353699|NCT03885934|FG004|Participant Flow|V114, Schedule C: Participants 2-17 Years|Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
11353700|NCT03885934|FG005|Participant Flow|Prevnar 13®, Schedule C: Participants 2-17 Years|Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
11353701|NCT03885934|OG000|Outcome|V114, Schedule A: Participants 7-11 Months|Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
11353702|NCT03885934|OG001|Outcome|Prevnar 13®, Schedule A: Participants 7-11 Months|Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
11353703|NCT03885934|OG000|Outcome|V114, Schedule B: Participants 12-23 Months|Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
11353704|NCT03885934|OG001|Outcome|Prevnar 13®, Schedule B: Participants 12-23 Months|Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
11353705|NCT03885934|OG000|Outcome|V114, Schedule C: Participants 2-17 Years|Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
11353706|NCT03885934|OG001|Outcome|Prevnar 13®, Schedule C: Participants 2-17 Years|Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
11353707|NCT03885934|EG000|Reported Event|V114 (7-11 Months)|Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
11353708|NCT03885934|EG001|Reported Event|Prevnar (7-11 Months)|Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
11353709|NCT03885934|EG002|Reported Event|V114 (12-23 Months)|Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
11353710|NCT03885934|EG003|Reported Event|Prevnar (12-23 Months)|Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
11353711|NCT03885934|EG004|Reported Event|V114 (2-17 Years)|Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
11353712|NCT03885934|EG005|Reported Event|Prevnar (2-17 Years)|Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
11353713|NCT03885726|BG000|Baseline|All Study Participants|"Crossover study design with the first intervention as Treatment as Usual - 6 minute walk test (TAU), followed by an adequate recovery period. The second intervention was High Velocity Nasal Insufflation - 6 minute walk test (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients."
11353714|NCT03885726|FG000|Participant Flow|All Study Participants|"Crossover study design with the first intervention as Treatment as Usual - 6 minute walk test (TAU), followed by an adequate recovery period. The second intervention was High Velocity Nasal Insufflation - 6 minute walk test (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients."
11353715|NCT03885726|OG000|Outcome|Treatment as Usual (Inpatient)|Treatment as Usual: Conventional therapy per institution
11353716|NCT03885726|OG001|Outcome|High Velocity Nasal Insufflation (Inpatient)|Precision Flow Plus: High Velocity Nasal Insufflation
11353717|NCT03885726|OG002|Outcome|Treatment as Usual (Outpatient)|Treatment as Usual: Conventional therapy per institution
11353718|NCT03885726|OG003|Outcome|High Velocity Nasal Insufflation (Outpatient)|Precision Flow Plus: High Velocity Nasal Insufflation
11353719|NCT03885726|EG000|Reported Event|Treatment as Usual|Treatment as Usual: Conventional therapy per institution
11353720|NCT03885726|EG001|Reported Event|High Velocity Nasal Insufflation|Precision Flow Plus: High velocity nasal insufflation
11353721|NCT03885154|BG000|Baseline|Valproic Acid|"An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours"
11353722|NCT03885154|BG001|Baseline|Dihydroergotamine|"Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353723|NCT03885154|BG002|Baseline|Cross-Over to Dihydroergotamine|"An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353724|NCT03885154|BG003|Baseline|Cross-Over to Valproic Acid|"Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353725|NCT03885154|BG004|Baseline|Total|Total of all reporting groups
11353726|NCT03885154|FG000|Participant Flow|Valproic Acid|"An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours"
11353727|NCT03885154|FG001|Participant Flow|Dihydroergotamine|"Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353728|NCT03885154|FG002|Participant Flow|Cross-Over to Dihydroergotamine|"An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353729|NCT03885154|FG003|Participant Flow|Cross-Over to Valproic Acid|"Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353730|NCT03885154|OG000|Outcome|Valproic Acid|"An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours"
11353731|NCT03885154|OG001|Outcome|Dihydroergotamine|"Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353732|NCT03885154|OG002|Outcome|Cross-Over to Dihydroergotamine|"An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353733|NCT03885154|OG003|Outcome|Cross-Over to Valproic Acid|"Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353734|NCT03885154|EG000|Reported Event|Valproic Acid|"An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.~Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours"
11353735|NCT03885154|EG001|Reported Event|Dihydroergotamine|"Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.~Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg"
11353736|NCT03883386|BG000|Baseline|Loratadine First|"Take treatment daily for 7 days.~Loratadine: 10 mg in a capsule~Placebo: Administered via capsule"
11353737|NCT03883386|BG001|Baseline|Placebo First|"Take placebo daily for 7 days.~Loratadine: 10 mg in a capsule~Placebo: Administered via capsule"
11353738|NCT03883386|BG002|Baseline|Total|Total of all reporting groups
11353739|NCT03883386|FG000|Participant Flow|Loratadine First|"Take treatment daily for 7 days.~Loratadine: 10 mg in a capsule~Placebo: Administered via capsule"
11353740|NCT03883386|FG001|Participant Flow|Placebo First|"Take placebo daily for 7 days.~Loratadine: 10 mg in a capsule~Placebo: Administered via capsule"
11353741|NCT03883386|OG000|Outcome|Loratadine|"Take treatment daily for 7 days.~Loratadine: 10 mg in a capsule"
11353742|NCT03883386|OG001|Outcome|Placebo|Take placebo by capsule daily for 7 days.
11353743|NCT03883386|EG000|Reported Event|Loratadine First|"Take treatment daily for 7 days.~Loratadine: 10 mg in a capsule~Placebo: Administered via capsule"
11353744|NCT03883386|EG001|Reported Event|Placebo First|"Take placebo daily for 7 days.~Loratadine: 10 mg in a capsule~Placebo: Administered via capsule"
11353745|NCT03882528|BG000|Baseline|Infective Controls|"Controlled Human Malaria Infection (CHMI) will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. Beginning 5 days after the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear.~Plasmodium falciparum malaria parasite: Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed)."
11353746|NCT03882528|FG000|Participant Flow|Infective Controls|"Controlled Human Malaria Infection (CHMI) will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. Beginning 5 days after the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear.~Plasmodium falciparum malaria parasite: Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed)."
11353747|NCT03882528|OG000|Outcome|Infective Controls|"Controlled Human Malaria Infection (CHMI) will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. Beginning 5 days after the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear.~Plasmodium falciparum malaria parasite: Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed)."
11353748|NCT03882528|EG000|Reported Event|Infective Controls|"Controlled Human Malaria Infection (CHMI) will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. Beginning 5 days after the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear.~Plasmodium falciparum malaria parasite: Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed)."
11353749|NCT03882801|BG000|Baseline|Placebo Then Gefapixant 180 mg|Placebo once daily at bedtime (QHS) oral for 7 days in Period 1 followed by a 7-day washout period and then Gefapixant, 180 mg, QHS, oral for 7 days in Period 2.
11353750|NCT03882801|BG001|Baseline|Gefapixant 180 mg Then Placebo|Gefapixant, 180 mg, QHS, oral for 7 days in Period 1 followed by a 7-day washout period and then placebo, QHS, oral for 7 days in Period 2.
11353751|NCT03882801|BG002|Baseline|Total|Total of all reporting groups
11353752|NCT03882801|FG000|Participant Flow|Placebo Then Gefapixant 180 mg|Placebo once daily at bedtime (QHS) oral for 7 days in Period 1 followed by a 7-day washout period and then Gefapixant, 180 mg, QHS, oral for 7 days in Period 2.
11353753|NCT03882801|FG001|Participant Flow|Gefapixant 180 mg Then Placebo|Gefapixant, 180 mg, QHS, oral for 7 days in Period 1 followed by a 7-day washout period and then placebo, QHS, oral for 7 days in Period 2.
11353754|NCT03882801|OG000|Outcome|Placebo|Placebo once daily at bedtime (QHS) taken orally for 7 days
11353755|NCT03882801|OG001|Outcome|Gefapixant 180 mg|Gefapixant, 180 mg, QHS, taken orally for 7 days
11353756|NCT03882801|EG000|Reported Event|Screening|Screening
11353757|NCT03882801|EG001|Reported Event|Gefapixant|Gefapixant 180 mg QHS taken orally for 7 days
11353758|NCT03882801|EG002|Reported Event|Placebo|Placebo once daily at bedtime (QHS) taken orally for 7 days
11353759|NCT03882801|EG003|Reported Event|Post Trial|Post trial
11353760|NCT03882424|BG000|Baseline|TRS003|"Proposed biosimilar of bevacizumab，Intravenous administration~TRS003: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353761|NCT03882424|BG001|Baseline|China-approved Bevacizumab|"Intravenous administration~China-approved Bevacizumab: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353762|NCT03882424|BG002|Baseline|US-licensed Avastin|"Intravenous administration~US-licensed Avastin: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353763|NCT03882424|BG003|Baseline|Total|Total of all reporting groups
11353764|NCT03882424|FG000|Participant Flow|TRS003|"Proposed biosimilar of bevacizumab，Intravenous administration~TRS003: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353765|NCT03882424|FG001|Participant Flow|China-approved Bevacizumab|"Intravenous administration~China-approved Bevacizumab: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353766|NCT03882424|FG002|Participant Flow|US-licensed Avastin|"Intravenous administration~US-licensed Avastin: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353767|NCT03882424|OG000|Outcome|TRS003|"Proposed biosimilar of bevacizumab，Intravenous administration~TRS003: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353768|NCT03882424|OG001|Outcome|China-approved Bevacizumab|"Intravenous administration~China-approved Bevacizumab: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353769|NCT03882424|OG002|Outcome|US-licensed Avastin|"Intravenous administration~US-licensed Avastin: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353770|NCT03882424|EG000|Reported Event|TRS003|"Proposed biosimilar of bevacizumab，Intravenous administration~TRS003: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353771|NCT03882424|EG001|Reported Event|China-approved Bevacizumab|"Intravenous administration~China-approved Bevacizumab: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353772|NCT03882424|EG002|Reported Event|US-licensed Avastin|"Intravenous administration~US-licensed Avastin: 25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes"
11353773|NCT03881163|BG000|Baseline|Overall - NAC 600 mg|All participants were dosed with NAC QD at 08:00 ± 1 hour on Day 1 under fasting conditions, BID at 08:00 ± 1 hour and 20:00 ± 1 hour on Day 4 and Day 5 after one 3-day wash-out, and QD at 08:00 ± 1 hour on Day 6.
11353774|NCT03881163|FG000|Participant Flow|Overall - NAC 600 mg|All participants were dosed with NAC once daily (QD) at 08:00 ± 1 hour on Day 1 under fasting conditions, twice daily (BID) at 08:00 ± 1 hour and 20:00 ± 1 hour on Day 4 and Day 5 after one 3-day wash-out, and QD at 08:00 ± 1 hour on Day 6.
11353775|NCT03881163|OG000|Outcome|Single Dose - NAC 600mg|Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
11353776|NCT03881163|OG000|Outcome|Multiple Dose - NAC 600mg|Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On days 4 and 5 at 08:00 ±1 hours and 20:00 ±1 hours and at 08:00 ±1 on day 6, 5 doses of 600 mg of NAC (300 + 300 mg ampoule) will be administered.
11353777|NCT03881163|OG000|Outcome|NAC 600 mg|All participants were dosed with NAC once daily (QD) at 08:00 ± 1 hour on Day 1 under fasting conditions, BID at 08:00 ± 1 hour and 20:00 ± 1 hour on Day 4 and Day 5 after one 3-day wash-out, and QD at 08:00 ± 1 hour on Day 6.
11353778|NCT03881163|EG000|Reported Event|Overall - NAC 600 mg|All participants were dosed with NAC once daily (QD) at 08:00 ± 1 hour on Day 1 under fasting conditions, BID at 08:00 ± 1 hour and 20:00 ± 1 hour on Day 4 and Day 5 after one 3-day wash-out, and QD at 08:00 ± 1 hour on Day 6.
11353779|NCT03881670|BG000|Baseline|Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe|First intervention (2+/-1day) Second intervention (2+/-1day)
11353780|NCT03881670|BG001|Baseline|Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B|First intervention (2+/-1day) Second intervention (2+/-1day)
11353781|NCT03881670|BG002|Baseline|Total|Total of all reporting groups
11353782|NCT03881670|FG000|Participant Flow|Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe|First intervention (2+/-1day) Second intervention (2+/-1day)
11353783|NCT03881670|FG001|Participant Flow|Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B|First intervention (2+/-1day) Second intervention (2+/-1day)
11353784|NCT03881670|OG000|Outcome|Lotrafilcon B|All subjects (randomized, crossover design)
11353785|NCT03881670|OG001|Outcome|Lotrafilcon B With Hydraluxe|All subjects (randomized, crossover design)
11353786|NCT03881670|OG000|Outcome|Lotrafilcon B|"Lotrafilcon B: commercially available contact lens~lotrafilcon B with Hydraluxe: commercially available contact lens"
11353787|NCT03881670|OG001|Outcome|Lotrafilcon B Hydraluxe|"Lotrafilcon B: commercially available contact lens~lotrafilcon B with Hydraluxe: commercially available contact lens"
11353788|NCT03881670|EG000|Reported Event|Lotrafilcon B|During wear of Lotrafilcon B, including all subjects, despite randomization
11353789|NCT03881670|EG001|Reported Event|Lotrafilcon B With Hydraluxe|During wear of Lotrafilcon B With Hydraluxe, including all subjects, despite randomization
11353790|NCT03880266|BG000|Baseline|Group 1 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
11353791|NCT03880266|BG001|Baseline|Group 1 Vehicle|Vehicle applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
11353792|NCT03880266|BG002|Baseline|Group 2 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
11353793|NCT03880266|BG003|Baseline|Group 2 Vehicle|Vehicle applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
11353794|NCT03880266|BG004|Baseline|Group 3 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
11353795|NCT03880266|BG005|Baseline|Group 3 Vehicle|Vehicle applied to the hands once daily for 14 days: 15 minutes
11353796|NCT03880266|BG006|Baseline|Group 4 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
11353797|NCT03880266|BG007|Baseline|Group 4 Vehicle|Vehicle applied to the hands once daily for 14 days: 30 minutes
11353798|NCT03880266|BG008|Baseline|Total|Total of all reporting groups
11353799|NCT03880266|FG000|Participant Flow|Group 1 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
11353800|NCT03880266|FG001|Participant Flow|Group 1 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
11353801|NCT03880266|FG002|Participant Flow|Group 2 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
11353802|NCT03880266|FG003|Participant Flow|Group 2 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
11353803|NCT03880266|FG004|Participant Flow|Group 3 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
11353804|NCT03880266|FG005|Participant Flow|Group 3 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
11353805|NCT03880266|FG006|Participant Flow|Group 4 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
11353806|NCT03880266|FG007|Participant Flow|Group 4 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
11353807|NCT03880266|OG000|Outcome|Group 1 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
11353808|NCT03880266|OG001|Outcome|Group 1 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
11353809|NCT03880266|OG002|Outcome|Group 2 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
11353810|NCT03880266|OG003|Outcome|Group 2 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
11353811|NCT03880266|OG004|Outcome|Group 3 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
11353812|NCT03880266|OG005|Outcome|Group 3 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
11353813|NCT03880266|OG006|Outcome|Group 4 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
11353814|NCT03880266|OG007|Outcome|Group 4 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
11353815|NCT03880266|EG000|Reported Event|Group 1 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
11353816|NCT03880266|EG001|Reported Event|Group 1 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
11353817|NCT03880266|EG002|Reported Event|Group 2 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
11168072|NCT01984229|EG004|Reported Event|Cohort B: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
11353818|NCT03880266|EG003|Reported Event|Group 2 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
11353819|NCT03880266|EG004|Reported Event|Group 3 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
11353820|NCT03880266|EG005|Reported Event|Group 3 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
11353821|NCT03880266|EG006|Reported Event|Group 4 Active|Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
11353822|NCT03880266|EG007|Reported Event|Group 4 Vehicle|Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
11353823|NCT03856320|BG000|Baseline|Usual Care|Patient attends a MOVE! visit (weight management visit).
11353824|NCT03856320|BG001|Baseline|Intervention|"Patient attends a MOVE! visit (weight management visit) and watches an educational video describing obesity treatment options available in the VA.~Educational Video: An educational video describing obesity treatment options available in the VA."
11353825|NCT03856320|BG002|Baseline|Total|Total of all reporting groups
11353826|NCT03856320|FG000|Participant Flow|Usual Care|Patient attends a MOVE! visit (weight management visit).
11353827|NCT03856320|FG001|Participant Flow|Intervention|"Patient attends a MOVE! visit (weight management visit) and watches an educational video describing obesity treatment options available in the VA.~Educational Video: An educational video describing obesity treatment options available in the VA."
10851310|NCT00305695|EG001|Reported Event|Arm II (Clinical Observation)|Patients are observed for 18 months after surgery.
10851311|NCT00305760|BG000|Baseline|Group 1|
11353828|NCT03856320|OG000|Outcome|All Attempted Recruitment|# of participants randomized to the study divided by # of participants sent a recruitment letter
11353829|NCT03856320|OG000|Outcome|Retention|# of participants who completed the one-week post-intervention assessment divided by # of participants who were randomized.
11353830|NCT03856320|EG000|Reported Event|Usual Care|Patient attends a MOVE! visit (weight management visit).
11353831|NCT03856320|EG001|Reported Event|Intervention|"Patient attends a MOVE! visit (weight management visit) and watches an educational video describing obesity treatment options available in the VA.~Educational Video: An educational video describing obesity treatment options available in the VA."
11353832|NCT03848871|BG000|Baseline|Enstilar Foam|"Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.~Enstilar: Enstilar foam applied to affected area once daily"
11353833|NCT03848871|FG000|Participant Flow|Enstilar Foam|"Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.~Enstilar: Enstilar foam applied to affected area once daily"
11353834|NCT03848871|OG000|Outcome|Enstilar Foam|"Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.~Enstilar: Enstilar foam applied to affected area once daily"
11353835|NCT03848871|EG000|Reported Event|Enstilar Foam|"Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.~Enstilar: Enstilar foam applied to affected area once daily"
11168073|NCT01984229|EG005|Reported Event|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
11168074|NCT01984242|BG000|Baseline|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
11168075|NCT01984242|BG001|Baseline|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
11168076|NCT01984242|BG002|Baseline|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
11168077|NCT01984242|BG003|Baseline|Total|Total of all reporting groups
11168078|NCT01984242|FG000|Participant Flow|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
11168079|NCT01984242|FG001|Participant Flow|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
11168080|NCT01984242|FG002|Participant Flow|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
11168081|NCT01984242|OG000|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
11168082|NCT01984242|OG001|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
11168083|NCT01984242|OG002|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
11168084|NCT01984242|OG000|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
11168085|NCT01984242|OG001|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
11168086|NCT01984242|OG002|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
11168087|NCT01984242|OG003|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
11168088|NCT01984242|OG001|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
11168089|NCT01984242|OG002|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
11168090|NCT01984242|EG000|Reported Event|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
11168091|NCT01984242|EG001|Reported Event|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
11168092|NCT01984242|EG002|Reported Event|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
11168093|NCT01984242|EG003|Reported Event|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
11168094|NCT01984242|EG004|Reported Event|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
11168095|NCT01984294|BG000|Baseline|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
11168096|NCT01984294|BG001|Baseline|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
11168097|NCT01984294|BG002|Baseline|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
11168098|NCT01984294|BG003|Baseline|Total|Total of all reporting groups
11168099|NCT01984294|FG000|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
11168100|NCT01984294|FG001|Participant Flow|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
11168101|NCT01984294|FG002|Participant Flow|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
11168102|NCT01984294|OG000|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
11168103|NCT01984294|OG001|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
11168104|NCT01984294|OG002|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
11168105|NCT01984294|EG000|Reported Event|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
11168106|NCT01984294|EG001|Reported Event|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
11168107|NCT01984294|EG002|Reported Event|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
11168108|NCT01984398|BG000|Baseline|12.5 mg Androxal (Formulations A and B)|"During Treatment Period 1, participants were randomly assigned to a single dose of either 12.5 mg Androxal Formulation A or 12.5 mg Androxal Formulation B.~After the washout period, participants then crossed over to receive the alternate 12.5 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B."
11168109|NCT01984398|BG001|Baseline|25 mg Androxal (Formulations A and B)|"During Treatment Period 1, participants were randomly assigned to a single dose of either 25 mg Androxal formulation A or 25 mg Androxal formulation B.~After the washout period, participants then crossed over to receive the alternate 25 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B."
11168110|NCT01984398|BG002|Baseline|Total|Total of all reporting groups
11168111|NCT01984398|FG000|Participant Flow|12.5 mg Androxal (Formulation A), Then B|"During Treatment Period 1, participants were randomly assigned to a single dose of either 12.5 mg Androxal Formulation A or 12.5 mg Androxal Formulation B.~After the washout period, participants then crossed over to receive the alternate 12.5 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B."
11168112|NCT01984398|FG001|Participant Flow|12.5 mg Androxal (Formulation B), Then A|"During Treatment Period 1, participants were randomly assigned to a single dose of either 12.5 mg Androxal Formulation A or 12.5 mg Androxal Formulation B.~After the washout period, participants then crossed over to receive the alternate 12.5 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B."
11168113|NCT01984398|FG002|Participant Flow|25 mg Androxal (Formulation A), Then B|"During Treatment Period 1, participants were randomly assigned to a single dose of either 25 mg Androxal formulation A or 25 mg Androxal formulation B.~After the washout period, participants then crossed over to receive the alternate 25 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B."
11168114|NCT01984398|FG003|Participant Flow|25 mg Androxal (Formulation B), Then A|"During Treatment Period 1, participants were randomly assigned to a single dose of either 25 mg Androxal formulation A or 25 mg Androxal formulation B.~After the washout period, participants then crossed over to receive the alternate 25 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B."
11168115|NCT01984398|OG000|Outcome|12.5 mg Androxal Formulation A|A single dose of 12.5 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.
11353836|NCT03880474|BG000|Baseline|MVA-NP+M1 Group|"Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected."
11353837|NCT03880474|BG001|Baseline|Saline Placebo Group|"Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected."
11353838|NCT03880474|BG002|Baseline|Total|Total of all reporting groups
11353839|NCT03880474|FG000|Participant Flow|MVA-NP+M1 Group (Main Cohort + Immunogenicity Cohort)|"Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected."
11353840|NCT03880474|FG001|Participant Flow|Saline Placebo Group (Main Cohort+ Immunogenicity Cohort)|"Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected."
11357266|NCT03762213|EG000|Reported Event|Oculus GO VR HMD, Application Happy Place (© Mimerse)|"Oculus GO is a stand-alone, consumer-grade, virtual reality head-mounted display (HMD). The HMD is placed on the head of the user blocking off the surrounding environment. The visuals and audio are relayed through the HMD in a virtual space.Happy Place (© Mimerse) is a publicly available application with an explicit intent to be used for chronic pain patients. It has the critical elements of VR, namely immersion and interactivity.~Immersion: The scene is a serene lakeside campground with guided relaxation and soothing music. The application intends to promote positive effects such as calmness and feeling of wonder.~Interactivity: Happy Place uses an innovative 'gaze-based interaction' with the virtual world. Around 50 'gaze objects' are placed around the scene and gazing at them would trigger an event.~The entire duration of the experience will be kept at 10 minutes.~Oculus GO VR HMD, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages)."
11168116|NCT01984398|OG001|Outcome|25 mg Androxal Formulation A|A single dose of 25 mg Androxal Formulation A, received either during Treatment Period 1 or Treatment Period 2.
10851312|NCT00305760|FG000|Participant Flow|Group 1: Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|
10851313|NCT00305760|OG000|Outcome|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|
11168117|NCT01984398|OG000|Outcome|12.5 mg Androxal Formulation B|A single dose of 12.5 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2.
11168118|NCT01984398|OG001|Outcome|25 mg Androxal Formulation B|A single dose of 25 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2.
11168119|NCT01984398|EG000|Reported Event|12.5 mg Androxal Formulation A|A single dose of 12.5 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.
11168120|NCT01984398|EG001|Reported Event|12.5mg Androxal Formulation B|A single dose of 12.5 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2.
11168121|NCT01984398|EG002|Reported Event|25 mg Androxal Formulation A|A single dose of 25 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.
11168122|NCT01984398|EG003|Reported Event|25 mg Androxal Formulation B|A single dose of 25 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2.
11168123|NCT01984424|BG000|Baseline|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
11168124|NCT01984424|BG001|Baseline|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
11168125|NCT01984424|BG002|Baseline|Total|Total of all reporting groups
11168126|NCT01984424|FG000|Participant Flow|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
11168127|NCT01984424|FG001|Participant Flow|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
11168128|NCT01984424|OG000|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
11168129|NCT01984424|OG001|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
11353841|NCT03880474|OG000|Outcome|MVA-NP+M1 Group|"Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected."
11353842|NCT03880474|OG001|Outcome|Saline Placebo Group|"Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected."
11353843|NCT03880474|EG000|Reported Event|MVA-NP+M1 Group|"Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected."
11353844|NCT03880474|EG001|Reported Event|Saline Placebo Group|"Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.~Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.~The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.~The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.~In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).~At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected."
11353845|NCT03878160|BG000|Baseline|Women and Men, <2 Years, Individual Interview|"Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11089670|NCT01524900|OG002|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
11231576|NCT02413255|OG009|Outcome|Part 1 Cohort 9: TAK-020 105 mg|TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
11231577|NCT02413255|OG000|Outcome|Part 2 Cohort 1-6: Placebo|TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9.
11231578|NCT02413255|OG001|Outcome|Part 2 Cohort 1: TAK-020 3.75 mg|TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.
11231579|NCT02413255|OG002|Outcome|Part 2 Cohort 2: TAK-020 5.75 mg|TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.
11231580|NCT02413255|OG003|Outcome|Part 2 Cohort 3: TAK-020 13 mg|TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.
11231581|NCT02413255|OG004|Outcome|Part 2 Cohort 4: TAK-020 25 mg|TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.
11231582|NCT02413255|OG005|Outcome|Part 2 Cohort 5: TAK-020 45 mg|TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.
11231583|NCT02413255|OG006|Outcome|Part 2 Cohort 6: TAK-020 60 mg|TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.
11231584|NCT02413255|OG000|Outcome|Part 1 Cohort 1: TAK-020 0.1 mg|TAK-020 0.1 milligram (mg), solution, orally once on Day 1.
11231585|NCT02413255|OG001|Outcome|Part 1 Cohort 2: TAK-020 0.5 mg|TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.
11231586|NCT02413255|OG002|Outcome|Part 1 Cohort 3: TAK-020 2.5 mg|TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.
11231587|NCT02413255|OG003|Outcome|Part 1 Cohort 4: TAK-020 4.4 mg|TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.
11231588|NCT02413255|OG004|Outcome|Part 1 Cohort 5: TAK-020 8.8 mg|TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.
11231589|NCT02413255|OG005|Outcome|Part 1 Cohort 6: TAK-020 17.5 mg|TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.
11231590|NCT02413255|OG006|Outcome|Part 1 Cohort 7: TAK-020 35 mg|TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.
11231591|NCT02413255|OG007|Outcome|Part 1 Cohort 8: TAK-020 70 mg|TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.
11231592|NCT02413255|OG008|Outcome|Part 1 Cohort 9: TAK-020 105 mg|TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
11231593|NCT02413255|OG000|Outcome|Part 2 Cohort 1: TAK-020 3.75 mg|TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.
11231594|NCT02413255|OG001|Outcome|Part 2 Cohort 2: TAK-020 5.75 mg|TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.
11231595|NCT02413255|OG002|Outcome|Part 2 Cohort 3: TAK-020 13 mg|TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.
11089671|NCT01524900|OG003|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
11231596|NCT02413255|OG003|Outcome|Part 2 Cohort 4: TAK-020 25 mg|TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.
11231597|NCT02413255|OG004|Outcome|Part 2 Cohort 5: TAK-020 45 mg|TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.
11231598|NCT02413255|OG005|Outcome|Part 2 Cohort 6: TAK-020 60 mg|TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.
11231599|NCT02413255|EG000|Reported Event|Part 1 Cohort 1-9: Placebo|TAK-020 placebo-matching solution, orally, once on Day 1.
11231600|NCT02413255|EG001|Reported Event|Part 1 Cohort 1: TAK-020 0.1 mg|TAK-020 0.1 milligram (mg), solution, orally once on Day 1.
11231601|NCT02413255|EG002|Reported Event|Part 1 Cohort 2: TAK-020 0.5 mg|TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.
11231602|NCT02413255|EG003|Reported Event|Part 1 Cohort 3: TAK-020 2.5 mg|TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.
11231603|NCT02413255|EG004|Reported Event|Part 1 Cohort 4: TAK-020 4.4 mg|TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.
11231604|NCT02413255|EG005|Reported Event|Part 1 Cohort 5: TAK-020 8.8 mg|TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.
11231605|NCT02413255|EG006|Reported Event|Part 1 Cohort 6: TAK-020 17.5 mg|TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.
11231606|NCT02413255|EG007|Reported Event|Part 1 Cohort 7: TAK-020 35 mg|TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.
11231607|NCT02413255|EG008|Reported Event|Part 1 Cohort 8: TAK-020 70 mg|TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.
11231608|NCT02413255|EG009|Reported Event|Part 1 Cohort 9: TAK-020 105 mg|TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
11231609|NCT02413255|EG010|Reported Event|Part 2 Cohort 1-6: Placebo|TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9.
11231610|NCT02413255|EG011|Reported Event|Part 2 Cohort 1: TAK-020 3.75 mg|TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.
11231611|NCT02413255|EG012|Reported Event|Part 2 Cohort 2: TAK-020 5.75 mg|TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.
11231612|NCT02413255|EG013|Reported Event|Part 2 Cohort 3: TAK-020 13 mg|TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.
11231613|NCT02413255|EG014|Reported Event|Part 2 Cohort 4: TAK-020 25 mg|TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.
11231614|NCT02413255|EG015|Reported Event|Part 2 Cohort 5: TAK-020 45 mg|TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.
11231615|NCT02413255|EG016|Reported Event|Part 2 Cohort 6: TAK-020 60 mg|TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.
11231616|NCT02413294|BG000|Baseline|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
11231617|NCT02413294|FG000|Participant Flow|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
11231618|NCT02413294|OG000|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
11231619|NCT02413294|EG000|Reported Event|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
11231620|NCT02413320|BG000|Baseline|Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide|Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
11231621|NCT02413320|BG001|Baseline|Carboplatin + Docetaxel|Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
11231622|NCT02413320|BG002|Baseline|Total|Total of all reporting groups
11231623|NCT02413320|FG000|Participant Flow|Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide|Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
11231624|NCT02413320|FG001|Participant Flow|Carboplatin + Docetaxel|Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
11089672|NCT01524900|OG004|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
11231625|NCT02413320|OG000|Outcome|Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide|Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
11231626|NCT02413320|OG001|Outcome|Carboplatin + Docetaxel|Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
11231627|NCT02413320|EG000|Reported Event|Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide|Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
11231628|NCT02413320|EG001|Reported Event|Carboplatin + Docetaxel|Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
11231629|NCT02413333|BG000|Baseline|Clear Care Plus, Then PeroxiClear|Clear Care Plus was used in Period 1, then PeroxiClear in Period 2.
11231630|NCT02413333|BG001|Baseline|PeroxiClear, Then Clear Care Plus|PeroxiClear was used in Period 1, then Clear Care Plus in Period 2.
11231631|NCT02413333|BG002|Baseline|Clear Care Plus, Then Clear Care Plus|Clear Care Plus was used in Period 1 and in Period 2.
11231632|NCT02413333|BG003|Baseline|PeroxiClear, Then PeroxiClear|PeroxiClear was used in Period 1 and in Period 2.
11231633|NCT02413333|BG004|Baseline|Total|Total of all reporting groups
11089673|NCT01524900|OG003|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
11089674|NCT01524900|EG000|Reported Event|Treatment-naïve Patients|Patients who were not pretreated with HIV therapy
11089675|NCT01524900|EG001|Reported Event|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
11089676|NCT01524900|EG002|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
11089677|NCT01524900|EG003|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/ML|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
11089678|NCT01524900|EG004|Reported Event|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
11089679|NCT01524913|BG000|Baseline|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
11089680|NCT01524913|BG001|Baseline|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
11089681|NCT01524913|BG002|Baseline|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
11089682|NCT01524913|BG003|Baseline|Total|Total of all reporting groups
11089683|NCT01524913|FG000|Participant Flow|Corticosteroid|Participants in this group received 1 milliliter (mL) of Celestone (6mg/mL) injected into the the superior joint space.
11089684|NCT01524913|FG001|Participant Flow|Hyaluronic Acid|Participants in the group received 1milliliter (mL) of Hyalgan (10 mg/mL) injected into the superior joint space.
11089685|NCT01524913|FG002|Participant Flow|Saline Placebo|Participants in this group received 1 milliliter (mL) of lactated Ringer's solution injected into the superior joint space.
11089686|NCT01524913|OG000|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
11089687|NCT01524913|OG001|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
11089688|NCT01524913|OG002|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
11089689|NCT01524913|EG000|Reported Event|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
11089690|NCT01524913|EG001|Reported Event|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
11089691|NCT01524913|EG002|Reported Event|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
11089692|NCT01524978|BG000|Baseline|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
11089693|NCT01524978|BG001|Baseline|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
11089694|NCT01524978|BG002|Baseline|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
11089695|NCT01524978|BG003|Baseline|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
11089696|NCT01524978|BG004|Baseline|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
11089697|NCT01524978|BG005|Baseline|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
11089698|NCT01524978|BG006|Baseline|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
11089699|NCT01524978|BG007|Baseline|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
11089700|NCT01524978|BG008|Baseline|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
11089701|NCT01524978|BG009|Baseline|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
11089702|NCT01524978|BG010|Baseline|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
11089703|NCT01524978|BG011|Baseline|Total|Total of all reporting groups
11089704|NCT01524978|FG000|Participant Flow|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
11089705|NCT01524978|FG001|Participant Flow|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
11089706|NCT01524978|FG002|Participant Flow|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
11089707|NCT01524978|FG003|Participant Flow|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
11089708|NCT01524978|FG004|Participant Flow|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
11089709|NCT01524978|FG005|Participant Flow|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
11089710|NCT01524978|FG006|Participant Flow|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
11089711|NCT01524978|FG007|Participant Flow|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
11089712|NCT01524978|FG008|Participant Flow|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
11168130|NCT01984424|EG000|Reported Event|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
11168131|NCT01984424|EG001|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe orally only a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
11168132|NCT01984515|BG000|Baseline|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
11168133|NCT01984515|FG000|Participant Flow|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
11168134|NCT01984515|OG000|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
11168135|NCT01984515|EG000|Reported Event|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
11357267|NCT03762213|EG001|Reported Event|iPad, Application Happy Place (© Mimerse)|"An iPad with earphones (Apple Inc. Cupertino CA) will be used for controls. The participants in control group will watch the same content for the same duration on an iPad screen (flat version of Happy Place). This experience will be different from the intervention group in two ways: first, lack of an immersive environment, and second, lack of interactivity with the environment.~iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages)."
11353846|NCT03878160|BG001|Baseline|Women and Men, >2 Years, Individual Interview|"Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353847|NCT03878160|BG002|Baseline|Women and Men, Lifetime History of ACS, Individual Interview|"Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353848|NCT03878160|BG003|Baseline|Total|Total of all reporting groups
11353849|NCT03878160|FG000|Participant Flow|Women and Men, <2 Years, Individual Interview|"Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353850|NCT03878160|FG001|Participant Flow|Women and Men, >2 Years, Individual Interview|"Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353851|NCT03878160|FG002|Participant Flow|Women and Men, Lifetime History of ACS, Individual Interview|"Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353852|NCT03878160|OG000|Outcome|Women and Men, <2 Years, Individual Interview|"Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353853|NCT03878160|OG001|Outcome|Women and Men, >2 Years, Individual Interview|"Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353854|NCT03878160|OG002|Outcome|Women and Men, Lifetime History of ACS, Individual Interview|"Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11089713|NCT01524978|FG009|Participant Flow|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
11353855|NCT03878160|EG000|Reported Event|Women and Men, <2 Years, Individual Interview|"Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11357268|NCT03762200|BG000|Baseline|SURGICEL Powder|Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
11357269|NCT03762200|FG000|Participant Flow|SURGICEL Powder|Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
11357270|NCT03762200|OG000|Outcome|SURGICEL Powder|Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
11357271|NCT03762200|EG000|Reported Event|SURGICEL Powder|Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
11353856|NCT03878160|EG001|Reported Event|Women and Men, >2 Years, Individual Interview|"Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353857|NCT03878160|EG002|Reported Event|Women and Men, Lifetime History of ACS, Individual Interview|"Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms.~Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis."
11353858|NCT03864627|BG000|Baseline|Placebo|Participants received MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency TCS once daily until Day 57.
11353859|NCT03864627|BG001|Baseline|MOR106 320 mg|Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
11353860|NCT03864627|BG002|Baseline|Total|Total of all reporting groups
11353861|NCT03864627|FG000|Participant Flow|Placebo|Participants received MOR106 matching placebo via subcutaneous (s.c.) injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency topical corticosteroid (TCS) once daily until Day 57.
11353862|NCT03864627|FG001|Participant Flow|MOR106 320 mg|Participants received MOR106 320 milligrams (mg) via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
11353863|NCT03864627|OG000|Outcome|Placebo|Participants received MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency TCS once daily until Day 57.
11353864|NCT03864627|OG001|Outcome|MOR106 320 mg|Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
11353865|NCT03864627|OG000|Outcome|MOR106 320 mg|Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
11353866|NCT03864627|EG000|Reported Event|Placebo|Participants received MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency TCS once daily until Day 57.
11353867|NCT03864627|EG001|Reported Event|MOR106 320 mg|Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
11353868|NCT03861000|BG000|Baseline|Brain PET Scan With 11C-T-1650 and Blocking With BPN14770|Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
11353869|NCT03861000|BG001|Baseline|Whole Body PET Scan With Intravenous 11C-T-1650|10 mCi of 11C-T-1650 given intravenously once followed by a Whole Body PET scan. This was done for whole body dosimetry calculations.
11353870|NCT03861000|BG002|Baseline|Total|Total of all reporting groups
11168136|NCT01984684|BG000|Baseline|Delafloxacin|300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
11353871|NCT03861000|FG000|Participant Flow|Brain PET Scan With 11C-T-1650 and Blocking With BPN14770|Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
11353872|NCT03861000|FG001|Participant Flow|Whole Body PET Scan With Intravenous 11C-T-1650|10 mCi of 11C-T-1650 given intravenously once followed by a Whole Body PET scan. This was done for whole body dosimetry calculations.
11353873|NCT03861000|OG000|Outcome|Brain PET Scan With 11C-T-1650 and Blocking With BPN14770|Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
11353874|NCT03861000|EG000|Reported Event|Brain PET Scan With 11C-T-1650 and Blocking With BPN14770|Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
11353875|NCT03861000|EG001|Reported Event|Whole Body PET Scan With Intravenous 11C-T-1650|10 mCi of 11C-T-1650 given intravenously once followed by a Whole Body PET scan. This was done for whole body dosimetry calculations.
11353876|NCT03848403|BG000|Baseline|All Study Participants|All randomized participants who received at least one 80 milligram (mg) dose of ixekizumab administered as an SC injection in a prefilled syringe in one of three periods.
11231634|NCT02413333|FG000|Participant Flow|Clear Care Plus, Then PeroxiClear|Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
11231635|NCT02413333|FG001|Participant Flow|PeroxiClear, Then Clear Care Plus|PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
11231636|NCT02413333|OG000|Outcome|PeroxiClear|PeroxiClear Lens Cases
11231637|NCT02413333|OG001|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
11231638|NCT02413333|EG000|Reported Event|PeroxiClear|While using PeroxiClear
11231639|NCT02413333|EG001|Reported Event|Clear Care Plus|While using Clear Care Plus
11231640|NCT02413346|BG000|Baseline|Placebo/Sarecycline|Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
11231641|NCT02413346|BG001|Baseline|Sarecycline/Sarecycline|Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
11231642|NCT02413346|BG002|Baseline|Total|Total of all reporting groups
11231643|NCT02413346|FG000|Participant Flow|Placebo/Sarecycline|Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(kg) sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
11231644|NCT02413346|FG001|Participant Flow|Sarecycline/Sarecycline|Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
11231645|NCT02413346|OG000|Outcome|Placebo/Sarecycline|Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
11231646|NCT02413346|OG001|Outcome|Sarecycline/Sarecycline|Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
11231647|NCT02413346|EG000|Reported Event|Placebo/Sarecycline|Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
11231648|NCT02413346|EG001|Reported Event|Sarecycline/Sarecycline|Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
11231649|NCT02413372|BG000|Baseline|BMS-986036 10 mg QD|Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.
11231650|NCT02413372|BG001|Baseline|BMS-986036 20 mg QW|Participants self-administered 20 mg SC injections of BMS-986036, once weekly (QW), for 16 weeks in a double-blind, outpatient setting. The injection for days 2-7 of each treatment week was placebo to maintain the blind between daily and weekly treatment arms.
11231651|NCT02413372|BG002|Baseline|Placebo QD|Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
11231652|NCT02413372|BG003|Baseline|Total|Total of all reporting groups
11231653|NCT02413372|FG000|Participant Flow|BMS-986036 10 mg QD|Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.
11231654|NCT02413372|FG001|Participant Flow|BMS-986036 20 mg QW|Participants self-administered 20 mg SC injections of BMS-986036, once weekly (QW), for 16 weeks in a double-blind, outpatient setting. The injection for days 2-7 of each treatment week was placebo to maintain the blind between daily and weekly treatment arms.
11231655|NCT02413372|FG002|Participant Flow|Placebo QD|Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
11231656|NCT02413372|OG000|Outcome|BMS-986036 10 mg QD|Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.
11231657|NCT02413372|OG001|Outcome|BMS-986036 20 mg QW|Participants self-administered 20 mg SC injections of BMS-986036, once weekly (QW), for 16 weeks in a double-blind, outpatient setting. The injection for days 2-7 of each treatment week was placebo to maintain the blind between daily and weekly treatment arms.
11231658|NCT02413372|OG002|Outcome|Placebo QD|Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
11231659|NCT02413372|EG000|Reported Event|BMS-986036 10 mg QD|Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.
11357272|NCT03761368|BG000|Baseline|RIPC Group|"The RIPC group underwent Remote Ischemic Preconditioning.~Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left arm cuff"
11353877|NCT03848403|FG000|Participant Flow|Sequence 1: ABC|"A: Reference formulation 80 milligram (mg) of Ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in Period 1.~B: Test 1 formulation 80 mg of Ixekizumab administered as an subcutaneous SC injection in a prefilled syringe in Period 2.~C: Test 2 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 3.~Sequence 1: ABC (Reference, Test 1, then Test 2)"
11353878|NCT03848403|FG001|Participant Flow|Sequence 2: BCA|"B: Test 1 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 1.~C: Test 2 formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 2.~A: Reference formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 3.~Sequence 2: BCA (Test 1, Test 2, Then Reference)"
11353879|NCT03848403|FG002|Participant Flow|Sequence 3: CAB|"C: Test 2 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 1.~A: Reference: formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 2.~B: Test 1 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 3.~Sequence 3: CAB (Test 2, Reference, Then Test 1)"
11353880|NCT03848403|OG000|Outcome|Ixekizumab (Reference)|Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.
11353881|NCT03848403|OG001|Outcome|Ixekizumab (Test 1)|Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe in one of three study periods.
11353882|NCT03848403|OG002|Outcome|Ixekizumab (Test 2)|Test 2 formulation ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
11353883|NCT03848403|EG000|Reported Event|Ixekizumab (Reference)|Reference formulation 80 mg ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.
11353884|NCT03848403|EG001|Reported Event|Ixekizumab (Test 1)|Test 1 formulation ixekizumab 80mg administered as an SC injection in a prefilled syringe in one of three study periods.
11353885|NCT03848403|EG002|Reported Event|Ixekizumab (Test 2)|Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe in one of three study periods.
11353886|NCT03847233|BG000|Baseline|Jetstream Atherectomy System|Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
11353887|NCT03847233|FG000|Participant Flow|Jetstream Atherectomy System|Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
11353888|NCT03847233|OG000|Outcome|Jetstream Atherectomy System on the PP Analysis Set|Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
11353889|NCT03847233|OG000|Outcome|Jetstream Atherectomy System on the ITT Analysis Set|Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
11353890|NCT03847233|EG000|Reported Event|Jetstream Atherectomy System on the ITT Analysis Set|Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
11353891|NCT03879603|BG000|Baseline|Group 1: 6 mcg WEVEE Vaccine|"6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353892|NCT03879603|BG001|Baseline|Group 2: 6 mcg WEVEE Vaccine + Alum|"6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11089714|NCT01524978|FG010|Participant Flow|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
11353893|NCT03879603|BG002|Baseline|Group 3: 30 mcg WEVEE Vaccine|"30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353894|NCT03879603|BG003|Baseline|Group 4: 30 mcg WEVEE Vaccine + Alum|"30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353895|NCT03879603|BG004|Baseline|Group 5: 60 mcg WEVEE Vaccine|"60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353896|NCT03879603|BG005|Baseline|Group 6: 60 mcg WEVEE Vaccine + Alum|"60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353897|NCT03879603|BG006|Baseline|Total|Total of all reporting groups
11353898|NCT03879603|FG000|Participant Flow|Group 1: 6 mcg WEVEE Vaccine|"6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered intramuscularly (IM) on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353899|NCT03879603|FG001|Participant Flow|Group 2: 6 mcg WEVEE Vaccine + Alum|"6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353900|NCT03879603|FG002|Participant Flow|Group 3: 30 mcg WEVEE Vaccine|"30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353901|NCT03879603|FG003|Participant Flow|Group 4: 30 mcg WEVEE Vaccine + Alum|"30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353902|NCT03879603|FG004|Participant Flow|Group 5: 60 mcg WEVEE Vaccine|"60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353903|NCT03879603|FG005|Participant Flow|Group 6: 60 mcg WEVEE Vaccine + Alum|"60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353904|NCT03879603|OG000|Outcome|Group 1: 6 mcg WEVEE Vaccine|"6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353905|NCT03879603|OG001|Outcome|Group 2: 6 mcg WEVEE Vaccine + Alum|"6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353906|NCT03879603|OG002|Outcome|Group 3: 30 mcg WEVEE Vaccine|"30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353907|NCT03879603|OG003|Outcome|Group 4: 30 mcg WEVEE Vaccine + Alum|"30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353908|NCT03879603|OG004|Outcome|Group 5: 60 mcg WEVEE Vaccine|"60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353909|NCT03879603|OG005|Outcome|Group 6: 60 mcg WEVEE Vaccine + Alum|"60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353910|NCT03879603|OG006|Outcome|Overall Incidence All Dosages (6, 30, and 60 mcg) WEVEE|VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)
11353911|NCT03879603|OG007|Outcome|Overall Incidence All Dosages (6, 30, and 60 mcg) WEVEE + Alum|"VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353912|NCT03879603|EG000|Reported Event|Group 1: 6 mcg WEVEE Vaccine|"6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353913|NCT03879603|EG001|Reported Event|Group 2: 6 mcg WEVEE Vaccine + Alum|"6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353914|NCT03879603|EG002|Reported Event|Group 3: 30 mcg WEVEE Vaccine|"30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353915|NCT03879603|EG003|Reported Event|Group 4: 30 mcg WEVEE Vaccine + Alum|"30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353916|NCT03879603|EG004|Reported Event|Group 5: 60 mcg WEVEE Vaccine|"60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)"
11353917|NCT03879603|EG005|Reported Event|Group 6: 60 mcg WEVEE Vaccine + Alum|"60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8~VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)~VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant"
11353918|NCT03878745|BG000|Baseline|All Study Participants|Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo
11353919|NCT03878745|FG000|Participant Flow|All Study Participants|Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo
11353920|NCT03878745|OG000|Outcome|All Study Participants|Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo
11353921|NCT03878745|OG000|Outcome|BD Nano™ PRO|All participants received 6 paired injections.
11353922|NCT03878745|OG001|Outcome|Terumo Nanopass|All participants received 6 paired injections
11353923|NCT03878745|OG000|Outcome|BD Nano™ PRO|Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo
11353924|NCT03878745|OG001|Outcome|Terumo Nanopass|Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo
11353925|NCT03878745|OG000|Outcome|BD Nano™ PRO|Subjects are to perform 6 pairs of injections.
11353926|NCT03878745|OG001|Outcome|Terumo Nanopass|All participants are to perform 6 pairs of injections
11353927|NCT03878745|OG000|Outcome|All Study Participants|Subject Satisfaction Survey
11353928|NCT03878745|EG000|Reported Event|BD Nano™ PRO|Subjects are to perform 6 pairs of injections.
11353929|NCT03878745|EG001|Reported Event|Terumo Nanopass|Subjects are to perform 6 pairs of injections.
11353930|NCT03848221|BG000|Baseline|Systane Complete|"Subjects in this group will use Systane Complete before, during, and after contact lens use.~Systane Complete: Systane Complete is an artificial tear."
11353931|NCT03848221|BG001|Baseline|Sensitive Eyes Rewetting Drops|"Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use.~Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop."
11353932|NCT03848221|BG002|Baseline|No Treatment|Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
11231660|NCT02413372|EG001|Reported Event|BMS-986036 20 mg QW|Participants self-administered 20 mg SC injections of BMS-986036, once weekly (QW), for 16 weeks in a double-blind, outpatient setting. The injection for days 2-7 of each treatment week was placebo to maintain the blind between daily and weekly treatment arms.
11231661|NCT02413372|EG002|Reported Event|Placebo QD|Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
11231662|NCT02413398|BG000|Baseline|Dapagliflozin 10mg QD|10 mg Tablets, Oral, Once daily, 24 weeks
11231663|NCT02413398|BG001|Baseline|Placebo|Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks
11231664|NCT02413398|BG002|Baseline|Total|Total of all reporting groups
11231665|NCT02413398|FG000|Participant Flow|Dapagliflozin 10mg QD|10 mg Tablets, Oral, Once daily, 24 weeks
11231666|NCT02413398|FG001|Participant Flow|Placebo QD|Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks
11231667|NCT02413398|OG000|Outcome|Dapagliflozin|10 mg Tablets, Oral, Once daily, 24 weeks
11231668|NCT02413398|OG001|Outcome|Placebo|Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks
11231669|NCT02413398|EG000|Reported Event|Dapagliflozin 10mg QD|10 mg Tablets, Oral, Once daily, 24 weeks
11231670|NCT02413398|EG001|Reported Event|Placebo|Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks
11231671|NCT02413463|BG000|Baseline|Augmented Recession|"The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles~augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)"
11231672|NCT02413463|BG001|Baseline|Faden|"Medial rectus muscle recession will be performed as described above with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.~Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)"
11231673|NCT02413463|BG002|Baseline|Total|Total of all reporting groups
11231674|NCT02413463|FG000|Participant Flow|Augmented Recession|"The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles~augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)"
11231675|NCT02413463|FG001|Participant Flow|Faden|"Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.~Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)"
11231676|NCT02413463|OG000|Outcome|Augmented Recession|"The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles~augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)"
11231677|NCT02413463|OG001|Outcome|Faden|"Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.~Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)"
11231678|NCT02413463|EG000|Reported Event|Augmented Recession|"The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles~augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)"
11231679|NCT02413463|EG001|Reported Event|Faden|"Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.~Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)"
11231680|NCT02413489|BG000|Baseline|Diffuse Large B-cell Lymphoma (DLBCL)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231681|NCT02413489|BG001|Baseline|Follicular Lymphoma (FL)|Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231682|NCT02413489|BG002|Baseline|Mantle Cell Lymphoma (MCL)|Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231683|NCT02413489|BG003|Baseline|Total|Total of all reporting groups
11231684|NCT02413489|FG000|Participant Flow|Diffuse Large B-cell Lymphoma (DLBCL)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11353933|NCT03848221|BG003|Baseline|Total|Total of all reporting groups
11353934|NCT03848221|FG000|Participant Flow|Systane Complete|"Subjects in this group will use Systane Complete before, during, and after contact lens use.~Systane Complete: Systane Complete is an artificial tear."
11353935|NCT03848221|FG001|Participant Flow|Sensitive Eyes Rewetting Drops|"Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use.~Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop."
11353936|NCT03848221|FG002|Participant Flow|No Treatment|Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
11353937|NCT03848221|OG000|Outcome|Systane Complete|"Subjects in this group will use Systane Complete before, during, and after contact lens use.~Systane Complete: Systane Complete is an artificial tear."
11353938|NCT03848221|OG001|Outcome|Sensitive Eyes Rewetting Drops|"Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use.~Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop."
11353939|NCT03848221|OG002|Outcome|No Treatment|Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
11353940|NCT03848221|EG000|Reported Event|Systane Complete|"Subjects in this group will use Systane Complete before, during, and after contact lens use.~Systane Complete: Systane Complete is an artificial tear."
11353941|NCT03848221|EG001|Reported Event|Sensitive Eyes Rewetting Drops|"Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use.~Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop."
11353942|NCT03848221|EG002|Reported Event|No Treatment|Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
11353943|NCT03878108|BG000|Baseline|LCHF Diet Then LFHC Diet|Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet
11353944|NCT03878108|BG001|Baseline|LFHC Diet Then LCHF Diet|Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet
11353945|NCT03878108|BG002|Baseline|Total|Total of all reporting groups
11353946|NCT03878108|FG000|Participant Flow|LCHF Diet Then LFHC Diet|Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet
11353947|NCT03878108|FG001|Participant Flow|LFHC Diet Then LCHF Diet|Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet
11353948|NCT03878108|OG000|Outcome|LC Diet|Low carbohydrate diet
11353949|NCT03878108|OG001|Outcome|LF Diet|Low fat diet
11353950|NCT03878108|EG000|Reported Event|LC Diet|Low carbohydrate diet
11353951|NCT03878108|EG001|Reported Event|LF Diet|Low fat diet
11353952|NCT03877432|BG000|Baseline|Dermatome Stimulation|"Check the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation.~Dermatome stimulation: Dermatome (S2-S4) stimulation is aimed at improving the function of bladder storage and bladder capacity. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. The minimum (or threshold) stimulation amplitude (T) necessary to elicit the genito-anal reflex was first determined for each subject. Subsequently, each subject received a randomized sequence of cystometric fill trials with and without continuous dermatome stimulation. The dermatome stimulation was randomly stimulated at stimulation amplitudes of 1, 2, 3, and 4 T."
11353953|NCT03877432|FG000|Participant Flow|Dermatome Stimulation|"Check the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation.~Dermatome stimulation: Dermatome (S2-S4) stimulation is aimed at improving the function of bladder storage and bladder capacity. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. The minimum (or threshold) stimulation amplitude (T) necessary to elicit the genito-anal reflex was first determined for each subject. Subsequently, each subject received a randomized sequence of cystometric fill trials with and without continuous dermatome stimulation. The dermatome stimulation was randomly stimulated at stimulation amplitudes of 1, 2, 3, and 4 T."
11089715|NCT01524978|OG000|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
11353954|NCT03877432|OG000|Outcome|Control|Subjects first received a control fill without genital nerve stimulation (GNS) to determine their bladder capacity (baseline).
11353955|NCT03877432|OG001|Outcome|1T (Threshold)|Subjects received 1 fold of stimulation threshold (1T) amplitude while cystometrogram performed.
11353956|NCT03877432|OG002|Outcome|2T (Threshold)|Subjects received 2 folds of stimulation threshold (2T) amplitude while cystometrogram performed.
11353957|NCT03877432|OG003|Outcome|3T (Threshold)|Subjects received 3 folds of stimulation threshold (3T) amplitude while cystometrogram performed.
11353958|NCT03877432|OG004|Outcome|4T (Threshold)|Subjects received 4 folds of stimulation threshold (4T) amplitude while cystometrogram performed.
11353959|NCT03877432|EG000|Reported Event|Dermatome Stimulation|"Check the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation.~Dermatome stimulation: Dermatome (S2-S4) stimulation is aimed at improving the function of bladder storage and bladder capacity. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. The minimum (or threshold) stimulation amplitude (T) necessary to elicit the genito-anal reflex was first determined for each subject. Subsequently, each subject received a randomized sequence of cystometric fill trials with and without continuous dermatome stimulation. The dermatome stimulation was randomly stimulated at stimulation amplitudes of 1, 2, 3, and 4 T."
11353960|NCT03877237|BG000|Baseline|Dapa 10mg|Dapagliflozin 10 mg, given once daily per oral use.
11353961|NCT03877237|BG001|Baseline|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11353962|NCT03877237|BG002|Baseline|Total|Total of all reporting groups
11353963|NCT03877237|FG000|Participant Flow|Dapa 10mg|Dapagliflozin 10 mg, given once daily per oral use.
11353964|NCT03877237|FG001|Participant Flow|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11353965|NCT03877237|OG000|Outcome|Dapa 10mg|Dapagliflozin 10 mg, given once daily per oral use.
11353966|NCT03877237|OG001|Outcome|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11353967|NCT03877237|EG000|Reported Event|Dapa 10mg|Dapagliflozin 10 mg, given once daily per oral use.
11353968|NCT03877237|EG001|Reported Event|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11353969|NCT03866434|BG000|Baseline|SPD422 + Omeprazole|Participants received 1 milligram (mg) of SPD422 (Anagrelide hydrochloride) (2*0.5 mg) capsule orally on Day 1 under fasted state (10 hours prior to and until 4 hours following administration of anagrelide), followed by 40 mg of Omeprazole capsule orally once daily (prior to breakfast) on Day 2 to Day 7, followed by 1 mg of Anagrelide under fasted state in combination with Omeprazole 40 mg on Day 8.
11353970|NCT03866434|FG000|Participant Flow|SPD422 + Omeprazole|Participants received 1 milligram (mg) of SPD422 (Anagrelide hydrochloride) (2*0.5 mg) capsule orally on Day 1 under fasted state (10 hours prior to and until 4 hours following administration of anagrelide), followed by 40 mg of Omeprazole capsule orally once daily (prior to breakfast) on Day 2 to Day 7, followed by 1 mg of Anagrelide under fasted state in combination with Omeprazole 40 mg on Day 8.
11353971|NCT03866434|OG000|Outcome|SPD422 (Day 1)|Participants received 1 milligram (mg) of SPD422 (Anagrelide hydrochloride) (2*0.5 mg) capsule orally on Day 1 under fasted state (10 hours prior to and until 4 hours following administration of anagrelide).
11353972|NCT03866434|OG001|Outcome|SPD422 + Omeprazole (Day 8)|Participants received 40 mg of Omeprazole capsule orally once daily (prior to breakfast) on Day 2 to Day 7, followed by received 1 mg of Anagrelide under fasted state in combination with Omeprazole 40 mg on Day 8.
11353973|NCT03866434|OG000|Outcome|SPD422 + Omeprazole|Participants received 1 milligram (mg) of SPD422 (Anagrelide hydrochloride) (2*0.5 mg) capsule orally on Day 1 under fasted state (10 hours prior to and until 4 hours following administration of anagrelide), followed by 40 mg of Omeprazole capsule orally once daily (prior to breakfast) on Day 2 to Day 7, followed by 1 mg of Anagrelide under fasted state in combination with Omeprazole 40 mg on Day 8.
11353974|NCT03866434|EG000|Reported Event|SPD422 + Omeprazole|Participants received 1 milligram (mg) of SPD422 (Anagrelide hydrochloride) (2*0.5 mg) capsule orally on Day 1 under fasted state (10 hours prior to and until 4 hours following administration of anagrelide), followed by 40 mg of Omeprazole capsule orally once daily (prior to breakfast) on Day 2 to Day 7, followed by 1 mg of Anagrelide under fasted state in combination with Omeprazole 40 mg on Day 8.
11353975|NCT03863210|BG000|Baseline|Participants Who Received Informations About Lifestyle Change|"60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk: All participants were exposed to the intervention. The intervention consisted of a 60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk. The lecture was delivered in family medicine offices by four specialists of family medicine individually to the groups of 6-8 participants. The lecture was verbal, harmonized among four family physicians, and contained instructions for changing nutrition habits, smoking habits and instructions for increasing physical activity. At the end of the lecture, each participant received a personally tailored decision aid, which included the list of her risk factors, assessment of the 10-year risk of fatal CVD (based on the data provided by the participants before the lecture), and instructions on what she should do in terms of changing the lifestyle habits."
11353976|NCT03863210|FG000|Participant Flow|Participants Who Received Informations About Lifestyle Change|"60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk: All participants were exposed to the intervention. The intervention consisted of a 60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk. The lecture was delivered in family medicine offices by four specialists of family medicine individually to the groups of 6-8 participants. The lecture was verbal, harmonized among four family physicians, and contained instructions for changing nutrition habits, smoking habits and instructions for increasing physical activity. At the end of the lecture, each participant received a personally tailored decision aid, which included the list of her risk factors, assessment of the 10-year risk of fatal CVD (based on the data provided by the participants before the lecture), and instructions on what she should do in terms of changing the lifestyle habits."
11168137|NCT01984684|BG001|Baseline|Vancomycin Plus Aztreonam|Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
11353977|NCT03863210|OG000|Outcome|Participants Who Received Informations About Lifestyle Change|"60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk: All participants were exposed to the intervention. The intervention consisted of a 60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk. The lecture was delivered in family medicine offices by four specialists of family medicine individually to the groups of 6-8 participants. The lecture was verbal, harmonized among four family physicians, and contained instructions for changing nutrition habits, smoking habits and instructions for increasing physical activity. At the end of the lecture, each participant received a personally tailored decision aid, which included the list of her risk factors, assessment of the 10-year risk of fatal CVD (based on the data provided by the participants before the lecture), and instructions on what she should do in terms of changing the lifestyle habits."
11353978|NCT03863210|EG000|Reported Event|Participants Who Received Informations About Lifestyle Change|"60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk: All participants were exposed to the intervention. The intervention consisted of a 60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk. The lecture was delivered in family medicine offices by four specialists of family medicine individually to the groups of 6-8 participants. The lecture was verbal, harmonized among four family physicians, and contained instructions for changing nutrition habits, smoking habits and instructions for increasing physical activity. At the end of the lecture, each participant received a personally tailored decision aid, which included the list of her risk factors, assessment of the 10-year risk of fatal CVD (based on the data provided by the participants before the lecture), and instructions on what she should do in terms of changing the lifestyle habits."
11168138|NCT01984684|BG002|Baseline|Total|Total of all reporting groups
11168139|NCT01984684|FG000|Participant Flow|Delafloxacin|300 mg IV Q12H for 6 doses, 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
11353979|NCT03859323|BG000|Baseline|Part 1: Single Ascending Dose (SAD): Placebo|Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
11353980|NCT03859323|BG001|Baseline|Part 1: Single Ascending Dose (SAD): 0.2 mg/kg|Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
11353981|NCT03859323|BG002|Baseline|Part 1: Single Ascending Dose (SAD): 0.5 mg/kg|Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
11353982|NCT03859323|BG003|Baseline|Part 1: Single Ascending Dose (SAD): 1 mg/kg|Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
11353983|NCT03859323|BG004|Baseline|Part 1: Single Ascending Dose (SAD): 2 mg/kg|Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
11353984|NCT03859323|BG005|Baseline|Part 1: Single Ascending Dose (SAD): 4 mg/kg|Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
11353985|NCT03859323|BG006|Baseline|Part 2: Multiple Ascending Dose (MAD): Placebo|Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11353986|NCT03859323|BG007|Baseline|Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg|Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11353987|NCT03859323|BG008|Baseline|Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg|Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11353988|NCT03859323|BG009|Baseline|Part 2: Multiple Ascending Dose (MAD): 1 mg/kg|Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11353989|NCT03859323|BG010|Baseline|Part 2: Multiple Ascending Dose (MAD): 2 mg/kg|Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11353990|NCT03859323|BG011|Baseline|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg|Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11089716|NCT01524978|OG001|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
11353991|NCT03859323|BG012|Baseline|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)|Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
11353992|NCT03859323|BG013|Baseline|Total|Total of all reporting groups
11353993|NCT03859323|FG000|Participant Flow|Part 1: Single Ascending Dose (SAD): Placebo|Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
11353994|NCT03859323|FG001|Participant Flow|Part 1: Single Ascending Dose (SAD): 0.2 mg/kg|Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
11353995|NCT03859323|FG002|Participant Flow|Part 1: Single Ascending Dose (SAD): 0.5 mg/kg|Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
11353996|NCT03859323|FG003|Participant Flow|Part 1: Single Ascending Dose (SAD): 1 mg/kg|Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
11353997|NCT03859323|FG004|Participant Flow|Part 1: Single Ascending Dose (SAD): 2 mg/kg|Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
11089717|NCT01524978|OG002|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
11089718|NCT01524978|OG003|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
11089719|NCT01524978|OG004|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
11089720|NCT01524978|OG005|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
11353998|NCT03859323|FG005|Participant Flow|Part 1: Single Ascending Dose (SAD): 4 mg/kg|Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
11353999|NCT03859323|FG006|Participant Flow|Part 2: Multiple Ascending Dose (MAD): Placebo|Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354000|NCT03859323|FG007|Participant Flow|Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg|Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354001|NCT03859323|FG008|Participant Flow|Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg|Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354002|NCT03859323|FG009|Participant Flow|Part 2: Multiple Ascending Dose (MAD): 1 mg/kg|Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354003|NCT03859323|FG010|Participant Flow|Part 2: Multiple Ascending Dose (MAD): 2 mg/kg|Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354004|NCT03859323|FG011|Participant Flow|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg|Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354005|NCT03859323|FG012|Participant Flow|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)|Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
11354006|NCT03859323|OG000|Outcome|Part 1: Single Ascending Dose (SAD): Placebo|Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
11354007|NCT03859323|OG001|Outcome|Part 1: Single Ascending Dose (SAD): 0.2 mg/kg|Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
11354008|NCT03859323|OG002|Outcome|Part 1: Single Ascending Dose (SAD): 0.5 mg/kg|Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
11354009|NCT03859323|OG003|Outcome|Part 1: Single Ascending Dose (SAD): 1 mg/kg|Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
11354010|NCT03859323|OG004|Outcome|Part 1: Single Ascending Dose (SAD): 2 mg/kg|Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
11354011|NCT03859323|OG005|Outcome|Part 1: Single Ascending Dose (SAD): 4 mg/kg|Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
11354012|NCT03859323|OG000|Outcome|Part 2: Multiple Ascending Dose (MAD): Placebo|Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11168140|NCT01984684|FG001|Participant Flow|Vancomycin Plus Aztreonam|Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
11168141|NCT01984684|OG000|Outcome|Delafloxacin|300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
11168142|NCT01984684|OG001|Outcome|Vancomycin Plus Aztreonam|Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
11168143|NCT01984684|EG000|Reported Event|Delafloxacin|300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
11168144|NCT01984684|EG001|Reported Event|Vancomycin Plus Aztreonam|Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
11168145|NCT01984697|BG000|Baseline|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168146|NCT01984697|BG001|Baseline|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168147|NCT01984697|BG002|Baseline|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168148|NCT01984697|BG003|Baseline|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
11168149|NCT01984697|BG004|Baseline|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
11168150|NCT01984697|BG005|Baseline|Total|Total of all reporting groups
11168151|NCT01984697|FG000|Participant Flow|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168152|NCT01984697|FG001|Participant Flow|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168153|NCT01984697|FG002|Participant Flow|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168154|NCT01984697|FG003|Participant Flow|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
11168155|NCT01984697|FG004|Participant Flow|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
11168156|NCT01984697|OG000|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168157|NCT01984697|OG001|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168158|NCT01984697|OG002|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168159|NCT01984697|OG003|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
11168160|NCT01984697|OG004|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
11168161|NCT01984697|EG000|Reported Event|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
11354013|NCT03859323|OG001|Outcome|Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg|Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11168162|NCT01984697|EG001|Reported Event|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168163|NCT01984697|EG002|Reported Event|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
11168164|NCT01984697|EG003|Reported Event|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
11168165|NCT01984697|EG004|Reported Event|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
11231685|NCT02413489|FG001|Participant Flow|Follicular Lymphoma (FL)|Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231686|NCT02413489|FG002|Participant Flow|Mantle Cell Lymphoma (MCL)|Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11354014|NCT03859323|OG002|Outcome|Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg|Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354015|NCT03859323|OG003|Outcome|Part 2: Multiple Ascending Dose (MAD): 1 mg/kg|Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354016|NCT03859323|OG004|Outcome|Part 2: Multiple Ascending Dose (MAD): 2 mg/kg|Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354017|NCT03859323|OG005|Outcome|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg|Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354018|NCT03859323|OG006|Outcome|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)|Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
11354019|NCT03859323|OG000|Outcome|Part 1: Single Ascending Dose (SAD): 0.2 mg/kg|Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
11354020|NCT03859323|OG001|Outcome|Part 1: Single Ascending Dose (SAD): 0.5 mg/kg|Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
11354021|NCT03859323|OG002|Outcome|Part 1: Single Ascending Dose (SAD): 1 mg/kg|Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
11354022|NCT03859323|OG003|Outcome|Part 1: Single Ascending Dose (SAD): 2 mg/kg|Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
11354023|NCT03859323|OG004|Outcome|Part 1: Single Ascending Dose (SAD): 4 mg/kg|Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
11354024|NCT03859323|OG000|Outcome|Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg|Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354025|NCT03859323|OG001|Outcome|Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg|Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354026|NCT03859323|OG002|Outcome|Part 2: Multiple Ascending Dose (MAD): 1 mg/kg|Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354027|NCT03859323|OG003|Outcome|Part 2: Multiple Ascending Dose (MAD): 2 mg/kg|Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354028|NCT03859323|OG004|Outcome|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg|Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354029|NCT03859323|OG005|Outcome|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)|Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
11354030|NCT03859323|EG000|Reported Event|Part 1: Single Ascending Dose (SAD): Placebo|Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
11354031|NCT03859323|EG001|Reported Event|Part 1: Single Ascending Dose (SAD): 0.2 mg/kg|Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
11354032|NCT03859323|EG002|Reported Event|Part 1: Single Ascending Dose (SAD): 0.5 mg/kg|Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
11354033|NCT03859323|EG003|Reported Event|Part 1: Single Ascending Dose (SAD): 1 mg/kg|Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
11354034|NCT03859323|EG004|Reported Event|Part 1: Single Ascending Dose (SAD): 2 mg/kg|Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
11354035|NCT03859323|EG005|Reported Event|Part 1: Single Ascending Dose (SAD): 4 mg/kg|Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
11354036|NCT03859323|EG006|Reported Event|Part 2: Multiple Ascending Dose (MAD): Placebo|Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354037|NCT03859323|EG007|Reported Event|Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg|Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354038|NCT03859323|EG008|Reported Event|Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg|Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354039|NCT03859323|EG009|Reported Event|Part 2: Multiple Ascending Dose (MAD): 1 mg/kg|Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354040|NCT03859323|EG010|Reported Event|Part 2: Multiple Ascending Dose (MAD): 2 mg/kg|Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354041|NCT03859323|EG011|Reported Event|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg|Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
11354042|NCT03859323|EG012|Reported Event|Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)|Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
11354043|NCT03867838|BG000|Baseline|All Participants|Stroke survivors with upper extremity motor impairments
11089721|NCT01524978|OG006|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
11354044|NCT03867838|FG000|Participant Flow|All Participants|Stroke survivors with upper extremity motor impairments
11354045|NCT03867838|OG000|Outcome|All Participants|Stroke survivors with upper extremity motor impairments
11354046|NCT03867838|EG000|Reported Event|All Participants|Stroke survivors with upper extremity motor impairments
11354047|NCT03855059|BG000|Baseline|Intervenous Steroid|Steroid given intervenously at the time of Peripheral nerve block
11354048|NCT03855059|BG001|Baseline|Perineural Steroid|Steroid given in syringe with the local anesthetic
11354049|NCT03855059|BG002|Baseline|Total|Total of all reporting groups
11354050|NCT03855059|FG000|Participant Flow|Intervenous Steroid|Steroid given intervenously at the time of Peripheral nerve block
11354051|NCT03855059|FG001|Participant Flow|Perineural Steroid|Steroid given in syringe with the local anesthetic
11354052|NCT03855059|OG000|Outcome|Intervenous Steroid|Steroid given intervenously at the time of Peripheral nerve block
11354053|NCT03855059|OG001|Outcome|Perineural Steroid|Steroid given in syringe with the local anesthetic
11354054|NCT03855059|EG000|Reported Event|Intervenous Steroid|Steroid given intervenously at the time of Peripheral nerve block
11231687|NCT02413489|OG000|Outcome|Diffuse Large B-cell Lymphoma (DLBCL)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231688|NCT02413489|OG001|Outcome|Follicular Lymphoma (FL)|Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231689|NCT02413489|OG002|Outcome|Mantle Cell Lymphoma (MCL)|Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231690|NCT02413489|EG000|Reported Event|Diffuse Large B-cell Lymphoma (DLBCL)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231691|NCT02413489|EG001|Reported Event|Follicular Lymphoma (FL)|Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231692|NCT02413489|EG002|Reported Event|Mantle Cell Lymphoma (MCL)|Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
11231693|NCT02413580|BG000|Baseline|IGIV-C Treatment|"An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.~IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days"
11089722|NCT01524978|OG007|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
11231694|NCT02413580|FG000|Participant Flow|IGIV-C Treatment|"An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.~IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days"
11231695|NCT02413580|OG000|Outcome|IGIV-C Treatment|"An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.~IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days"
11231696|NCT02413580|EG000|Reported Event|IGIV-C Treatment|"An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.~IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days"
11231697|NCT02413593|BG000|Baseline|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11231698|NCT02413593|FG000|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11231699|NCT02413593|OG000|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11231700|NCT02413593|EG000|Reported Event|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11231701|NCT02413684|BG000|Baseline|Asthma Patients|"Patient engagement toolkit~Patient engagement toolkit: Pack Health LLC and Duke will develop a patient engagement toolkit known as Packs to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care"
11231702|NCT02413684|FG000|Participant Flow|Asthma Patients|"Patient engagement toolkit~Patient engagement toolkit: Pack Health LLC and Duke will develop a patient engagement toolkit known as Packs to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care"
11231703|NCT02413684|OG000|Outcome|Asthma Patients|"Patient engagement toolkit~Patient engagement toolkit: Pack Health LLC and Duke will develop a patient engagement toolkit known as Packs to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care"
11231704|NCT02413684|EG000|Reported Event|Asthma Patients|"Patient engagement toolkit~Patient engagement toolkit: Pack Health LLC and Duke will develop a patient engagement toolkit known as Packs to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care"
11231705|NCT02413879|BG000|Baseline|Treatment Arm|All study subjects will be treated using the CleanCision device.
11231706|NCT02413879|FG000|Participant Flow|Treatment Group|All study subjects were treated using the CleanCision device.
11231707|NCT02413879|OG000|Outcome|Treatment Arm|All study subjects will be treated using the CleanCision device.
11231708|NCT02413879|EG000|Reported Event|Treatment Arm|All study subjects will be treated using the CleanCision device.
11231709|NCT02413918|BG000|Baseline|Open Label Iloperidone|"open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.~iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine."
11231710|NCT02413918|FG000|Participant Flow|Open Label Iloperidone|"open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.~iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine."
11231711|NCT02413918|OG000|Outcome|Mean Change in Depression for Study Completers|Measurement of mean change in depression for all subjects who entered study and completed 20 weeks
11231712|NCT02413918|OG001|Outcome|Mean Change in Mania for Study Completers|Measurement of mean change in mania for all study participants who completed 20 weeks.
11354055|NCT03855059|EG001|Reported Event|Perineural Steroid|Steroid given in syringe with the local anesthetic
11354056|NCT03852537|BG000|Baseline|Usual Care|"Corticosteroid use and dosing determined by the patient's primary team for standard of care.~Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care."
11354057|NCT03852537|BG001|Baseline|Biomarker-adjusted Steroid Dosing|"Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP < 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level > 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone).~Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'."
11354058|NCT03852537|BG002|Baseline|Total|Total of all reporting groups
11354059|NCT03852537|FG000|Participant Flow|Usual Care|"Corticosteroid use and dosing determined by the patient's primary team for standard of care.~Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care."
11354060|NCT03852537|FG001|Participant Flow|Biomarker-adjusted Steroid Dosing|"Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP < 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level > 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone).~Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'."
11354061|NCT03852537|OG000|Outcome|Usual Care|"Corticosteroid use and dosing determined by the patient's primary team for standard of care.~Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care."
11354062|NCT03852537|OG001|Outcome|Biomarker-adjusted Steroid Dosing|"Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP < 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level > 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone).~Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'."
11354063|NCT03852537|EG000|Reported Event|Usual Care|"Corticosteroid use and dosing determined by the patient's primary team for standard of care.~Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care."
11354064|NCT03852537|EG001|Reported Event|Biomarker-adjusted Steroid Dosing|"Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP < 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level > 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone).~Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'."
11354065|NCT03875859|BG000|Baseline|Remetinostat|"Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.~Remetinostat: Topical 1% remetinostat gel"
11354066|NCT03875859|FG000|Participant Flow|Remetinostat|"Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.~Remetinostat: Topical 1% remetinostat gel"
11354067|NCT03875859|OG000|Outcome|Remetinostat|"Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.~Remetinostat: Topical 1% remetinostat gel"
11354068|NCT03875859|EG000|Reported Event|Remetinostat|"Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.~Remetinostat: Topical 1% remetinostat gel"
11354069|NCT03875508|BG000|Baseline|Risankizumab|Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
11354070|NCT03875508|FG000|Participant Flow|Risankizumab|Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
11354071|NCT03875508|OG000|Outcome|Risankizumab|Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
11354072|NCT03875508|EG000|Reported Event|Risankizumab|Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
11354073|NCT03869333|BG000|Baseline|Invaplex[AR-Detox] 2.5 μg|Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354074|NCT03869333|BG001|Baseline|Invaplex[AR-Detox] 10 μg|Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354075|NCT03869333|BG002|Baseline|Invaplex[AR-Detox] 25 μg|Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354076|NCT03869333|BG003|Baseline|Placebo|Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
11354077|NCT03869333|BG004|Baseline|Total|Total of all reporting groups
11354078|NCT03869333|FG000|Participant Flow|Invaplex[AR-Detox] 2.5 μg|Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354079|NCT03869333|FG001|Participant Flow|Invaplex[AR-Detox] 10 μg|Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354080|NCT03869333|FG002|Participant Flow|Invaplex[AR-Detox] 25 μg|Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354081|NCT03869333|FG003|Participant Flow|Placebo|Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
11354082|NCT03869333|OG000|Outcome|Invaplex[AR-Detox] 2.5 μg|Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354083|NCT03869333|OG001|Outcome|Invaplex[AR-Detox] 10 μg|Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354084|NCT03869333|OG002|Outcome|Invaplex[AR-Detox] 25 μg|Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354085|NCT03869333|OG003|Outcome|Placebo|Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
11354086|NCT03869333|EG000|Reported Event|Invaplex[AR-Detox] 2.5 μg|Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354087|NCT03869333|EG001|Reported Event|Invaplex[AR-Detox] 10 μg|Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354088|NCT03869333|EG002|Reported Event|Invaplex[AR-Detox] 25 μg|Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43.
11354089|NCT03869333|EG003|Reported Event|Placebo|Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
11354090|NCT03864900|BG000|Baseline|The Intervention Group|"The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.~The medication adherence intervention: The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls."
11354091|NCT03864900|BG001|Baseline|The Control Group|Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health.
11354092|NCT03864900|BG002|Baseline|Total|Total of all reporting groups
11354093|NCT03864900|FG000|Participant Flow|The Intervention Group|"The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.~The medication adherence intervention: The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls."
11354094|NCT03864900|FG001|Participant Flow|The Control Group|Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health.
11354095|NCT03864900|OG000|Outcome|The Intervention Group|"The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.~The medication adherence intervention: The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls."
11354096|NCT03864900|OG001|Outcome|The Control Group|Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health.
11354097|NCT03864900|EG000|Reported Event|The Intervention Group|"The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.~The medication adherence intervention: The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls."
11354098|NCT03864900|EG001|Reported Event|The Control Group|Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health.
11354099|NCT03863795|BG000|Baseline|Smoking Stigma, Self-Affirmation|Participants viewed a 30-s smoking stigma anti-smoking paid PSA video. Participants ranked 11 values from most to least important. Those in the self-affirmation condition wrote a short paragraph about their most important value (rank 1), describing why it was personally important and how they applied it in daily life.
11089723|NCT01524978|OG008|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
11089724|NCT01524978|OG009|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
11089725|NCT01524978|OG010|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
11089726|NCT01524978|EG000|Reported Event|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
11089727|NCT01524978|EG001|Reported Event|Pooled Arm - Vemurafenib|Participants with a variety of cancer types, who were treated with vemurafenib monotherapy, were combined into this arm.
11354100|NCT03863795|BG001|Baseline|Smoking Stigma, No-Affirmation Control|Participants viewed a 30-s smoking stigma anti-smoking paid PSA video. Participants ranked 11 values from most to least important. Participants in the no-affirmation control condition wrote a short paragraph about their lowest-ranked value (rank 11), describing why it might be important to someone else.
11354101|NCT03863795|BG002|Baseline|Non-Stigma Control, Self-Affirmation|Participants viewed a 30-s smoking non-stigma control paid PSA video. Participants ranked 11 values from most to least important. Those in the self-affirmation condition wrote a short paragraph about their most important value (rank 1), describing why it was personally important and how they applied it in daily life.
11354102|NCT03863795|BG003|Baseline|Non-Stigma Control, No-Affirmation Control|Participants viewed a 30-s smoking non-stigma control paid PSA video. Participants ranked 11 values from most to least important. Participants in the no-affirmation control condition wrote a short paragraph about their lowest-ranked value (rank 11), describing why it might be important to someone else.
11354103|NCT03863795|BG004|Baseline|Total|Total of all reporting groups
11357273|NCT03761368|BG001|Baseline|Control Group|"Patients from control group had sham Remote Ischemic Preconditioning.~Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min"
11357274|NCT03761368|BG002|Baseline|Total|Total of all reporting groups
11231713|NCT02413918|OG002|Outcome|Mean Change in Depression for All Study Participants|Mean change in depression for all study participants, including early terminators.
11231714|NCT02413918|OG003|Outcome|Mean Change in Mania for All Study Participants|Mean change in mania for all study participants, including early terminators
11231715|NCT02413918|EG000|Reported Event|Open Label Iloperidone|"open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.~iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine."
11231716|NCT02413996|BG000|Baseline|VRRS Rehabilitation|"exercise therapy through a virtual reality rehabilitation system (VRRS) in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)~Kinetec® knee continuous passive motion (CPM ): CPM of the knee~Functional activities: Stairs, walking~VRRS rehabilitation: exercise therapy through a virtual reality rehabilitation system (VRRS)"
11231717|NCT02413996|BG001|Baseline|Traditional Rehabilitation|"exercise therapy through a traditional rehabilitation training in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)~Kinetec® knee continuous passive motion (CPM ): CPM of the knee~Functional activities: Stairs, walking~traditional rehabilitation: exercise therapy through a traditional rehabilitation training made by physiotherapists"
11231718|NCT02413996|BG002|Baseline|Total|Total of all reporting groups
11231719|NCT02413996|FG000|Participant Flow|VRRS Rehabilitation|"exercise therapy through a virtual reality rehabilitation system (VRRS) in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)~Kinetec® knee continuous passive motion (CPM ): CPM of the knee~Functional activities: Stairs, walking~VRRS rehabilitation: exercise therapy through a virtual reality rehabilitation system (VRRS)"
11231720|NCT02413996|FG001|Participant Flow|Traditional Rehabilitation|"exercise therapy through a traditional rehabilitation training in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)~Kinetec® knee continuous passive motion (CPM ): CPM of the knee~Functional activities: Stairs, walking~traditional rehabilitation: exercise therapy through a traditional rehabilitation training made by physiotherapists"
11231721|NCT02413996|OG000|Outcome|VRRS Rehabilitation|"exercise therapy through a virtual reality rehabilitation system (VRRS) in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)~Kinetec® knee continuous passive motion (CPM ): CPM of the knee~Functional activities: Stairs, walking~VRRS rehabilitation: exercise therapy through a virtual reality rehabilitation system (VRRS)"
11231722|NCT02413996|OG001|Outcome|Traditional Rehabilitation|"exercise therapy through a traditional rehabilitation training in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)~Kinetec® knee continuous passive motion (CPM ): CPM of the knee~Functional activities: Stairs, walking~traditional rehabilitation: exercise therapy through a traditional rehabilitation training made by physiotherapists"
11231723|NCT02413996|EG000|Reported Event|VRRS Rehabilitation|"exercise therapy through a virtual reality rehabilitation system (VRRS) in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)~Kinetec® knee continuous passive motion (CPM ): CPM of the knee~Functional activities: Stairs, walking~VRRS rehabilitation: exercise therapy through a virtual reality rehabilitation system (VRRS)"
11231724|NCT02413996|EG001|Reported Event|Traditional Rehabilitation|"exercise therapy through a traditional rehabilitation training in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)~Kinetec® knee continuous passive motion (CPM ): CPM of the knee~Functional activities: Stairs, walking~traditional rehabilitation: exercise therapy through a traditional rehabilitation training made by physiotherapists"
11231725|NCT02414204|BG000|Baseline|Sildenafil|"20 mg twice a day orally~Sildenafil: Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis."
11231726|NCT02414204|BG001|Baseline|Placebo|"Placebo twice a day orally~Placebo: Placebo will be over encapsulated to identical to drug comparison"
11231727|NCT02414204|BG002|Baseline|Total|Total of all reporting groups
11231728|NCT02414204|FG000|Participant Flow|Sildenafil|"20 mg twice a day orally~Sildenafil: Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis."
11231729|NCT02414204|FG001|Participant Flow|Placebo|"Placebo twice a day orally~Placebo: Placebo will be over encapsulated to identical to drug comparison"
11231730|NCT02414204|OG000|Outcome|Sildenafil|"20 mg twice a day orally~Sildenafil: Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis."
11231731|NCT02414204|OG001|Outcome|Placebo|"Placebo twice a day orally~Placebo: Placebo will be over encapsulated to identical to drug comparison"
11231732|NCT02414204|EG000|Reported Event|Sildenafil|"20 mg twice a day orally~Sildenafil: Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis."
11231733|NCT02414204|EG001|Reported Event|Placebo|"Placebo twice a day orally~Placebo: Placebo will be over encapsulated to identical to drug comparison"
11231734|NCT02414243|BG000|Baseline|New Aminoacid Formula + Control|Patients that followed the sequence: New aminoacid formula + control formula
11231735|NCT02414243|BG001|Baseline|Control Formula + New Aminoacid Formula|Patients that followed the sequence: control formula + new aminoacid formula
11231736|NCT02414243|BG002|Baseline|Total|Total of all reporting groups
11354104|NCT03863795|FG000|Participant Flow|Smoking Stigma, Self-Affirmation|Participants viewed a 30-s smoking stigma anti-smoking paid PSA video. Participants ranked 11 values from most to least important. Those in the self-affirmation condition wrote a short paragraph about their most important value (rank 1), describing why it was personally important and how they applied it in daily life.
11354105|NCT03863795|FG001|Participant Flow|Smoking Stigma, No-Affirmation Control|Participants viewed a 30-s smoking stigma anti-smoking paid PSA video. Participants ranked 11 values from most to least important. Participants in the no-affirmation control condition wrote a short paragraph about their lowest-ranked value (rank 11), describing why it might be important to someone else.
11354106|NCT03863795|FG002|Participant Flow|Non-Stigma Control, Self-Affirmation|Participants viewed a 30-s smoking non-stigma control paid PSA video. Participants ranked 11 values from most to least important. Those in the self-affirmation condition wrote a short paragraph about their most important value (rank 1), describing why it was personally important and how they applied it in daily life.
11354107|NCT03863795|FG003|Participant Flow|Non-Stigma Control, No-Affirmation Control|Participants viewed a 30-s smoking non-stigma control paid PSA video. Participants ranked 11 values from most to least important. Participants in the no-affirmation control condition wrote a short paragraph about their lowest-ranked value (rank 11), describing why it might be important to someone else.
11354108|NCT03863795|OG000|Outcome|Smoking Stigma, Self-Affirmation|Participants viewed a 30-s smoking stigma anti-smoking paid PSA video. Participants ranked 11 values from most to least important. Those in the self-affirmation condition wrote a short paragraph about their most important value (rank 1), describing why it was personally important and how they applied it in daily life.
11354109|NCT03863795|OG001|Outcome|Smoking Stigma, No-Affirmation Control|Participants viewed a 30-s smoking stigma anti-smoking paid PSA video. Participants ranked 11 values from most to least important. Participants in the no-affirmation control condition wrote a short paragraph about their lowest-ranked value (rank 11), describing why it might be important to someone else.
11354110|NCT03863795|OG002|Outcome|Non-Stigma Control, Self-Affirmation|Participants viewed a 30-s smoking non-stigma control paid PSA video. Participants ranked 11 values from most to least important. Those in the self-affirmation condition wrote a short paragraph about their most important value (rank 1), describing why it was personally important and how they applied it in daily life.
11354111|NCT03863795|OG003|Outcome|Non-Stigma Control, No-Affirmation Control|Participants viewed a 30-s smoking non-stigma control paid PSA video. Participants ranked 11 values from most to least important. Participants in the no-affirmation control condition wrote a short paragraph about their lowest-ranked value (rank 11), describing why it might be important to someone else.
11354112|NCT03863795|EG000|Reported Event|Smoking Stigma, Self-Affirmation|Participants viewed a 30-s smoking stigma anti-smoking paid PSA video. Participants ranked 11 values from most to least important. Those in the self-affirmation condition wrote a short paragraph about their most important value (rank 1), describing why it was personally important and how they applied it in daily life.
11354113|NCT03863795|EG001|Reported Event|Smoking Stigma, No-Affirmation Control|Participants viewed a 30-s smoking stigma anti-smoking paid PSA video. Participants ranked 11 values from most to least important. Participants in the no-affirmation control condition wrote a short paragraph about their lowest-ranked value (rank 11), describing why it might be important to someone else.
11354114|NCT03863795|EG002|Reported Event|Non-Stigma Control, Self-Affirmation|Participants viewed a 30-s smoking non-stigma control paid PSA video. Participants ranked 11 values from most to least important. Those in the self-affirmation condition wrote a short paragraph about their most important value (rank 1), describing why it was personally important and how they applied it in daily life.
11354115|NCT03863795|EG003|Reported Event|Non-Stigma Control, No-Affirmation Control|Participants viewed a 30-s smoking non-stigma control paid PSA video. Participants ranked 11 values from most to least important. Participants in the no-affirmation control condition wrote a short paragraph about their lowest-ranked value (rank 11), describing why it might be important to someone else.
11354116|NCT03875482|BG000|Baseline|Risankizumab|Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
11231737|NCT02414243|FG000|Participant Flow|New Amino Acid Formula + Control Formula|"New Amino-Acid based Infant Formula and then control formula and then open challenge with new amino acid formula~New Amino Acid formula: Ordesa's Amino-Acid based Infant Formula"
11231738|NCT02414243|FG001|Participant Flow|Control Formula + New Amino Acid Formula|"Commercially available Amino Acid Formula + New Amino Acid formula + open challenge with newm formula~Commercially available Amino Acid Formula: Commercially available Amino Acid Formula"
11231739|NCT02414243|OG000|Outcome|DBPCFC (New Milk SanorE)|DBPCFC: Double blind placebo controlled food challenge (New milk)
11231740|NCT02414243|OG001|Outcome|DBPCFC (Control Milk Neocate)|DBPCFC: Double blind placebo controlled food challenge (control milk)
11231741|NCT02414243|OG002|Outcome|Open Challenge With SanorE|Open challenge with SanorE phase
11231742|NCT02414243|OG000|Outcome|Global|Cow's Milk Allergy related Symptoms (Vandenplas)
11231743|NCT02414243|EG000|Reported Event|Global|Data from all participants in the study. Data has been presented globally in the final report, no results from different groups. Only occurrence of adverse events.
11231744|NCT02414633|BG000|Baseline|Humira|Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
11231745|NCT02414633|FG000|Participant Flow|Humira|Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
11231746|NCT02414633|OG000|Outcome|Humira|Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
11231747|NCT02414633|EG000|Reported Event|Humira|Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
11354117|NCT03875482|BG001|Baseline|Placebo|Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
11354118|NCT03875482|BG002|Baseline|Total|Total of all reporting groups
11354119|NCT03875482|FG000|Participant Flow|Risankizumab|Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
11354120|NCT03875482|FG001|Participant Flow|Placebo|Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
11354121|NCT03875482|OG000|Outcome|Risankizumab|Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
11354122|NCT03875482|OG001|Outcome|Placebo|Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
11354123|NCT03875482|EG000|Reported Event|Risankizumab|Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
11354124|NCT03875482|EG001|Reported Event|Placebo|Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
11354125|NCT03874377|BG000|Baseline|Mindfulness|The mindfulness intervention consists of 6 weekly sessions, blending material from the evidence-based Learning to BREATHE and Mindfulness-Based Eating Awareness Training manualized interventions. Sessions will focus on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.Participants in this arm will also receive the usual care provided by the weight management clinic.
11354126|NCT03874377|FG000|Participant Flow|Mindfulness|The mindfulness intervention consists of 6 weekly sessions, blending material from the evidence-based Learning to BREATHE and Mindfulness-Based Eating Awareness Training manualized interventions. Sessions will focus on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.Participants in this arm will also receive the usual care provided by the weight management clinic.
11354127|NCT03874377|OG000|Outcome|Mindfulness|The mindfulness intervention consists of 6 weekly sessions, blending material from the evidence-based Learning to BREATHE and Mindfulness-Based Eating Awareness Training manualized interventions. Sessions will focus on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.Participants in this arm will also receive the usual care provided by the weight management clinic.
11354128|NCT03874377|EG000|Reported Event|Mindfulness|The mindfulness intervention consists of 6 weekly sessions, blending material from the evidence-based Learning to BREATHE and Mindfulness-Based Eating Awareness Training manualized interventions. Sessions will focus on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.Participants in this arm will also receive the usual care provided by the weight management clinic.
11354129|NCT03863496|BG000|Baseline|Neuromuscular Scoliosis|Scoliosis surgery: All patients will be implanted with telescopic connector Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control (NIM Eclipse, Stealth Station S7) and standard anesthetic support.
11354130|NCT03863496|FG000|Participant Flow|Neuromuscular Scoliosis|Scoliosis surgery: All patients will be implanted Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control and standard anesthetic support.
11354131|NCT03863496|OG000|Outcome|Neuromuscular Scoliosis|Scoliosis surgery: All patients will be implanted Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control and standard anesthetic support.
11354132|NCT03863496|OG000|Outcome|Neuromuscular Scoliosis|Scoliosis surgery: All patients will be implanted with telescopic connector Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control and standard anesthetic support.
11354133|NCT03863496|OG000|Outcome|Neuromuscular Scoliosis|Scoliosis surgery: All patients will be implanted Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control (NIM Eclipse, Stealth Station S7) and standard anesthetic support.
11354134|NCT03863496|EG000|Reported Event|Neuromuscular Scoliosis|Scoliosis surgery: All patients will be implanted Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control (NIM Eclipse, Stealth Station S7) and standard anesthetic support.
11354135|NCT03874013|BG000|Baseline|MOD-4023 Treatment Arm|"MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.~MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.~MOD-4023 will be administered as a SC injection once weekly, using a delivery device."
11357275|NCT03761368|FG000|Participant Flow|RIPC Group|"The RIPC group underwent Remote Ischemic Preconditioning.~Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff"
11357276|NCT03761368|FG001|Participant Flow|Control Group|"Patients from control group had sham Remote Ischemic Preconditioning.~Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min"
11231748|NCT02414828|BG000|Baseline|Placebo|Sterile buffer, Intramuscular (IM)
11231749|NCT02414828|BG001|Baseline|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
11231750|NCT02414828|BG002|Baseline|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
11231751|NCT02414828|BG003|Baseline|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
11231752|NCT02414828|BG004|Baseline|Total|Total of all reporting groups
11231753|NCT02414828|FG000|Participant Flow|Placebo|Sterile buffer, Intramuscular (IM)
11231754|NCT02414828|FG001|Participant Flow|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
11231755|NCT02414828|FG002|Participant Flow|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
11231756|NCT02414828|FG003|Participant Flow|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
11231757|NCT02414828|OG000|Outcome|Placebo|Sterile Buffer, Intramuscular (IM)
11231758|NCT02414828|OG001|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
11231759|NCT02414828|OG002|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
11231760|NCT02414828|OG003|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
11231761|NCT02414828|OG000|Outcome|Placebo|Sterile buffer, IM
11231762|NCT02414828|EG000|Reported Event|Placebo|Sterile buffer, Intramuscular (IM)
11231763|NCT02414828|EG001|Reported Event|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
11231764|NCT02414828|EG002|Reported Event|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
11231765|NCT02414828|EG003|Reported Event|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
11231766|NCT02414841|BG000|Baseline|Vonapanitase|Vonapanitase administered at the time of radiocephalic fistula creation
11231767|NCT02414841|BG001|Baseline|Placebo|Placebo administered at the time of radiocephalic fistula creation
11231768|NCT02414841|BG002|Baseline|Total|Total of all reporting groups
11231769|NCT02414841|FG000|Participant Flow|Vonapanitase|"Vonapanitase administered at the time of radiocephalic fistula creation~vonapanitase"
11231770|NCT02414841|FG001|Participant Flow|Placebo|"Placebo administered at the time of radiocephalic fistula creation~Placebo"
11231771|NCT02414841|OG000|Outcome|Vonapanitase|"Vonapanitase administered at the time of radiocephalic fistula creation~Vonapanitase"
11231772|NCT02414841|OG001|Outcome|Placebo|"Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.~Placebo"
11231773|NCT02414841|OG000|Outcome|Vonapanitase|Vonapanitase administered at the time of radiocephalic fistula creation
11231774|NCT02414841|OG001|Outcome|Placebo|Placebo administered at the time of radiocephalic fistula creation
11231775|NCT02414841|EG000|Reported Event|Vonapanitase|Vonapanitase administered at the time of radiocephalic fistula creation
11231776|NCT02414841|EG001|Reported Event|Placebo|Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.
11231777|NCT02414854|BG000|Baseline|Placebo (for Dupilumab 200 mg) q2w|2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231778|NCT02414854|BG001|Baseline|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231779|NCT02414854|BG002|Baseline|Placebo (for Dupilumab 300 mg) q2w|2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231780|NCT02414854|BG003|Baseline|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231781|NCT02414854|BG004|Baseline|Total|Total of all reporting groups
11231782|NCT02414854|FG000|Participant Flow|Placebo (for Dupilumab 200 mg) q2w|2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable inhaled corticosteroid (ICS) and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231783|NCT02414854|FG001|Participant Flow|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231784|NCT02414854|FG002|Participant Flow|Placebo (for Dupilumab 300 mg) q2w|2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231785|NCT02414854|FG003|Participant Flow|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231786|NCT02414854|OG000|Outcome|Placebo (for Dupilumab 200 mg) q2w|2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231787|NCT02414854|OG001|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231788|NCT02414854|OG002|Outcome|Placebo (for Dupilumab 300 mg) q2w|2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231789|NCT02414854|OG003|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231790|NCT02414854|EG000|Reported Event|Placebo (for Dupilumab 200 mg) q2w|2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. 2 participants were excluded, who were randomized to this arm but received single injection of Dupilumab 200 mg q2w and 300 mg q2w, respectively.
11231791|NCT02414854|EG001|Reported Event|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. 2 participants were included, who were randomized to Placebo (for Dupilumab 200 mg) arm and Dupilumab 300 mg arm, respectively but both received Dupilumab 200 mg.
11231792|NCT02414854|EG002|Reported Event|Placebo (for Dupilumab 300 mg) q2w|2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
11231793|NCT02414854|EG003|Reported Event|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. 1 participant was excluded, who was randomized to this arm but received single injection of Dupilumab 200 mg q2w. 1 participant was included, who was randomized to Placebo (for Dupilumab 200 mg) arm but received Dupilumab 300 mg.
11231794|NCT02414932|BG000|Baseline|Ketamine|"Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate >110/minute or systolic/diastolic blood pressure (BP) >180/100 or >20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.~Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland"
11231795|NCT02414932|BG001|Baseline|Midazolam|"Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.~Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd"
11231796|NCT02414932|BG002|Baseline|Total|Total of all reporting groups
11231797|NCT02414932|FG000|Participant Flow|Ketamine|"Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate >110/minute or systolic/diastolic blood pressure (BP) >180/100 or >20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.~Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland"
11231798|NCT02414932|FG001|Participant Flow|Midazolam|"Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.~Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd"
11231799|NCT02414932|OG000|Outcome|Ketamine|"Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate >110/minute or systolic/diastolic blood pressure (BP) >180/100 or >20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.~Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland"
11231800|NCT02414932|OG001|Outcome|Midazolam|"Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.~Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd"
11357277|NCT03761368|OG000|Outcome|RIPC Group|"The RIPC group underwent Remote Ischemic Preconditioning.~Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff"
11231801|NCT02414932|EG000|Reported Event|Ketamine|"Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate >110/minute or systolic/diastolic blood pressure (BP) >180/100 or >20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.~Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland"
11231802|NCT02414932|EG001|Reported Event|Midazolam|"Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.~Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd"
11231803|NCT02414958|BG000|Baseline|Placebo Matching Empagliflozin|Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks
11231804|NCT02414958|BG001|Baseline|Empagliflozin 10 mg|Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
11231805|NCT02414958|BG002|Baseline|Empagliflozin 25 mg|Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
11231806|NCT02414958|BG003|Baseline|Total|Total of all reporting groups
11231807|NCT02414958|FG000|Participant Flow|Placebo Matching Empagliflozin|Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks
11231808|NCT02414958|FG001|Participant Flow|Empagliflozin 10 mg|Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
11231809|NCT02414958|FG002|Participant Flow|Empagliflozin 25 mg|Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
11231810|NCT02414958|OG000|Outcome|Placebo Matching Empagliflozin|Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks
11231811|NCT02414958|OG001|Outcome|Empagliflozin 10 mg|Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
11231812|NCT02414958|OG002|Outcome|Empagliflozin 25 mg|Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
11231813|NCT02414958|EG000|Reported Event|Placebo Matching Empagliflozin|Patients administered placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.
11231814|NCT02414958|EG001|Reported Event|Empagliflozin 10 mg|Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.
11231815|NCT02414958|EG002|Reported Event|Empagliflozin 25 mg|Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.
11231816|NCT02415127|BG000|Baseline|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
11231817|NCT02415127|BG001|Baseline|Placebo|SC doses of placebo TIW for a total of 26 weeks.
11231818|NCT02415127|BG002|Baseline|Total|Total of all reporting groups
11231819|NCT02415127|FG000|Participant Flow|Interferon γ-1b|Subcutaneous (SC) doses of ACTIMMUNE® 3 times a week (TIW) for a total of 26 weeks.
11231820|NCT02415127|FG001|Participant Flow|Placebo|SC doses of placebo TIW for a total of 26 weeks.
11231821|NCT02415127|OG000|Outcome|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
11231822|NCT02415127|OG001|Outcome|Placebo|SC doses of placebo TIW for a total of 26 weeks.
11231823|NCT02415127|EG000|Reported Event|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
11231824|NCT02415127|EG001|Reported Event|Placebo|SC doses of placebo TIW for a total of 26 weeks.
11231825|NCT02415244|BG000|Baseline|Age 0 - 18|"TEE visualization of the spinal cords in patients age between 0 - 3~TEE: Spinal cord segments will be imaged using the TEE"
11231826|NCT02415244|BG001|Baseline|Age 18 Plus|"TEE visualization of the spinal cords in patients age 18 or greater~TEE: Spinal cord segments will be imaged using the TEE"
11231827|NCT02415244|BG002|Baseline|Total|Total of all reporting groups
11231828|NCT02415244|FG000|Participant Flow|Age 0 - 18|"TEE visualization of the spinal cords in patients age between 0 - 18~TEE: Spinal cord segments will be imaged using the TEE"
11231829|NCT02415244|FG001|Participant Flow|Age 18 Plus|"TEE visualization of the spinal cords in patients age 18 or greater~TEE: Spinal cord segments will be imaged using the TEE"
11231830|NCT02415244|OG000|Outcome|Pediatric Group|Visible thoracic epidural segments were counted in pediatric patients with TEE
11231831|NCT02415244|OG001|Outcome|Adult Group|Visible thoracic epidural segments were counted with TEE
11231832|NCT02415244|EG000|Reported Event|Pediatric Group|Pediatric subjects
11231833|NCT02415244|EG001|Reported Event|Adult Group|Adult subjects
11231834|NCT02415400|BG000|Baseline|Apixaban With Acetylsalicylic Acid Film Coated Tablet|5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231835|NCT02415400|BG001|Baseline|Apixaban With Placebo Matching Acetylsalicylic Acid|5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231836|NCT02415400|BG002|Baseline|Vitamin K Antagonist (VKA) With Acetylsalicylic|VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11354136|NCT03874013|BG001|Baseline|Genotropin Treatment Arm|"Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).~Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.~A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.~Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week)."
11354137|NCT03874013|BG002|Baseline|Total|Total of all reporting groups
11354138|NCT03874013|FG000|Participant Flow|MOD-4023 Treatment Arm|"MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.~MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.~MOD-4023 will be administered as a SC injection once weekly, using a delivery device."
11354139|NCT03874013|FG001|Participant Flow|Genotropin Treatment Arm|"Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).~Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.~A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.~Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week)."
11354140|NCT03874013|OG000|Outcome|MOD-4023 Treatment Arm|"MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.~MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.~MOD-4023 will be administered as a SC injection once weekly, using a delivery device."
11354141|NCT03874013|OG001|Outcome|Genotropin Treatment Arm|"Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).~Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.~A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.~Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week)."
11354142|NCT03874013|EG000|Reported Event|MOD-4023 Treatment Arm|"MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.~MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.~MOD-4023 will be administered as a SC injection once weekly, using a delivery device."
11354143|NCT03874013|EG001|Reported Event|Genotropin Treatment Arm|"Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).~Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.~A delivery device (GenotropinÒ) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.~Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week)."
11354144|NCT03873116|BG000|Baseline|Berotralstat 110mg Once Daily|Berotralstat administered as two 55mg capsules, orally QD for 24 weeks.
11354145|NCT03873116|BG001|Baseline|Berotralstat 150mg Once Daily|Berotralstat administered as two 75mg capsules, orally QD for 24 weeks.
11354146|NCT03873116|BG002|Baseline|Placebo|Placebo administered as two 2 matching capsules, orally QD for24 weeks.
11354147|NCT03873116|BG003|Baseline|Total|Total of all reporting groups
11354148|NCT03873116|FG000|Participant Flow|Berotralstat 110mg Once Daily|Berotralstat administered as two 55mg capsules, orally QD for 24 weeks.
11354149|NCT03873116|FG001|Participant Flow|Berotralstat 150mg Once Daily|Berotralstat administered as two 75mg capsules, orally QD for 24 weeks.
11354150|NCT03873116|FG002|Participant Flow|Placebo|Placebo administered as two 2 matching capsules, orally QD for24 weeks.
11354151|NCT03873116|OG000|Outcome|Berotralstat 110mg Once Daily|Berotralstat administered as two 55mg capsules, orally QD for 24 weeks.
11354152|NCT03873116|OG001|Outcome|Berotralstat 150mg Once Daily|Berotralstat administered as two 75mg capsules, orally QD for 24 weeks.
11354153|NCT03873116|OG002|Outcome|Placebo|Placebo administered as two 2 matching capsules, orally QD for24 weeks.
11354154|NCT03873116|EG000|Reported Event|Berotralstat 110mg Once Daily|Berotralstat administered as two 55mg capsules, orally QD for 24 weeks.
11354155|NCT03873116|EG001|Reported Event|Berotralstat 150mg Once Daily|Berotralstat administered as two 75mg capsules, orally QD for 24 weeks.
11089728|NCT01524991|BG000|Baseline|Treatment|"Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)~Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)~Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)~Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)"
11354156|NCT03873116|EG002|Reported Event|Placebo|Placebo administered as two 2 matching capsules, orally QD for24 weeks.
11354157|NCT03872843|BG000|Baseline|Opioid Group|"This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement.~Norco 5milligram-325milligram Tablet: Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later."
11354158|NCT03872843|BG001|Baseline|Non-Opioid Group|"This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement.~Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED: Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later."
11354159|NCT03872843|BG002|Baseline|Total|Total of all reporting groups
11354160|NCT03872843|FG000|Participant Flow|Opioid Group|"This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement.~Norco 5milligram-325milligram Tablet: Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later."
11354161|NCT03872843|FG001|Participant Flow|Non-Opioid Group|"This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement.~Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED: Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later."
11354162|NCT03872843|OG000|Outcome|Opioid Group|"This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement.~Norco 5milligram-325milligram Tablet: Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later."
11354163|NCT03872843|OG001|Outcome|Non-Opioid Group|"This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement.~Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED: Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later."
11354164|NCT03872843|EG000|Reported Event|Opioid Group|"This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement.~Norco 5milligram-325milligram Tablet: Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later."
11354165|NCT03872843|EG001|Reported Event|Non-Opioid Group|"This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement.~Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED: Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later."
11354166|NCT03870997|BG000|Baseline|People With Diabetes:Intervention|Participant demographics
11354167|NCT03870997|BG001|Baseline|People With Diabetes: Control|Participant demographics
11354168|NCT03870997|BG002|Baseline|Normal Controls-Similar: Intervention|Participant demographics
11354169|NCT03870997|BG003|Baseline|Normal Controls-Similar : Control|Participant demographics
11354170|NCT03870997|BG004|Baseline|Normal Controls: Intervention|Participant demographics
11354171|NCT03870997|BG005|Baseline|Normal Controls: Control|Participant demographics
11354172|NCT03870997|BG006|Baseline|Total|Total of all reporting groups
11354173|NCT03870997|FG000|Participant Flow|People With Diabetes: Intervention|Individuals with self-reported diabetes who receive the Diabetes Digital Intervention
11354174|NCT03870997|FG001|Participant Flow|People With Diabetes: Control|Individuals with self-reported diabetes who received no digital intervention
11354175|NCT03870997|FG002|Participant Flow|Normal Controls-Similar: Intervention|Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received the Generic Digital Intervention
11354176|NCT03870997|FG003|Participant Flow|Normal Controls-Similar: Control|Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received no digital intervention
11354177|NCT03870997|FG004|Participant Flow|Normal Controls: Intervention|Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received the Generic Digital Intervention
11231837|NCT02415400|BG003|Baseline|VKA With Placebo Matching Acetylsalicylic Acid|VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231838|NCT02415400|BG004|Baseline|Total|Total of all reporting groups
11231839|NCT02415400|FG000|Participant Flow|Apixaban With Acetylsalicylic Acid Film Coated Tablet|5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231840|NCT02415400|FG001|Participant Flow|Apixaban With Placebo Matching Acetylsalicylic Acid|5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231841|NCT02415400|FG002|Participant Flow|Vitamin K Antagonist (VKA) With Acetylsalicylic Acid|VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231842|NCT02415400|FG003|Participant Flow|VKA With Placebo Matching Acetylsalicylic Acid|VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231843|NCT02415400|OG000|Outcome|Apixaban|5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
11231844|NCT02415400|OG001|Outcome|Vitamin K Antagonist|VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
11231845|NCT02415400|OG000|Outcome|Acetylsalicylic Acid Film Coated Tablet|81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231846|NCT02415400|OG001|Outcome|Placebo Matching Acetylsalicylic Acid Film Coated Tablet|Placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231847|NCT02415400|EG000|Reported Event|Apixaban With Acetylsalicylic Acid Film Coated Tablet|5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231848|NCT02415400|EG001|Reported Event|Apixaban With Placebo Matching Acetylsalicylic Acid|5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231849|NCT02415400|EG002|Reported Event|Vitamin K Antagonist (VKA) With Acetylsalicylic Acid|VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231850|NCT02415400|EG003|Reported Event|VKA With Placebo Matching Acetylsalicylic Acid|VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
11231851|NCT02415400|EG004|Reported Event|APIXABAN ONLY|Only Apixaban intervention received: 5 mg or 2.5 mg Apixaban tablets orally twice per day
11231852|NCT02415400|EG005|Reported Event|VKA ONLY|Only VKA intervention received: VKA tablets orally once daily
11231853|NCT02415400|EG006|Reported Event|ACETYLSALICLIC ACID ONLY|Only acetylsalicylic acid intervention received: 81 mg Acetylsalicylic acid film coated tablet orally once daily
11231854|NCT02415400|EG007|Reported Event|PLACEBO MATCHING ACETYLSALICLIC ACID ONLY|Only placebo matching acetylsalicylic acid intervention received: placebo matching Acetylsalicylic acid film coated tablet orally once daily
11231855|NCT02415439|BG000|Baseline|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions
11231856|NCT02415439|BG001|Baseline|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions
11231857|NCT02415439|BG002|Baseline|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions
11231858|NCT02415439|BG003|Baseline|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions
11231859|NCT02415439|BG004|Baseline|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions
11231860|NCT02415439|BG005|Baseline|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal
11231861|NCT02415439|BG006|Baseline|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions
11231862|NCT02415439|BG007|Baseline|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions
11231863|NCT02415439|BG008|Baseline|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions
11231864|NCT02415439|BG009|Baseline|VBP15 - 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions
11231865|NCT02415439|BG010|Baseline|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions
11231866|NCT02415439|BG011|Baseline|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions
11231867|NCT02415439|BG012|Baseline|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions
11231868|NCT02415439|BG013|Baseline|Total|Total of all reporting groups
11231869|NCT02415439|FG000|Participant Flow|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
11231870|NCT02415439|FG001|Participant Flow|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
11231871|NCT02415439|FG002|Participant Flow|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
11231872|NCT02415439|FG003|Participant Flow|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
11231873|NCT02415439|FG004|Participant Flow|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
11354178|NCT03870997|FG005|Participant Flow|Normal Controls: Controls|Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received no Digital Intervention
11354179|NCT03870997|OG000|Outcome|Diabetes Digital Intervention|People with diabetes who received digital intervention compared to people with diabetes who did not receive digital intervention
11168166|NCT01984892|BG000|Baseline|Participants With Stage 4 Cancer|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
11168167|NCT01984892|FG000|Participant Flow|IT and IM Injections Poly-ICLC|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
11168168|NCT01984892|OG000|Outcome|Participants With Stage 4 Cancer|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
11168169|NCT01984892|EG000|Reported Event|Participants With Stage 4 Cancer|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
11168170|NCT01985126|BG000|Baseline|Daratumumab 8 mg/kg|Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
11168171|NCT01985126|BG001|Baseline|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
11168172|NCT01985126|BG002|Baseline|Total|Total of all reporting groups
11168173|NCT01985126|FG000|Participant Flow|Daratumumab 8 mg/kg|Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
11168174|NCT01985126|FG001|Participant Flow|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
11168175|NCT01985126|OG000|Outcome|Daratumumab 8 mg/kg|Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
11354180|NCT03870997|EG000|Reported Event|People With Diabetes: Intervention|Individuals with self-reported diabetes who receive the Diabetes Digital Intervention
11168176|NCT01985126|OG001|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
11354181|NCT03870997|EG001|Reported Event|People With Diabetes: Control|Individuals with self-reported diabetes who received no digital intervention
11354182|NCT03870997|EG002|Reported Event|Normal Controls-Similar: Intervention|Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received the Generic Digital Intervention
11354183|NCT03870997|EG003|Reported Event|Normal Controls-Similar: Control|Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received no digital intervention
11354184|NCT03870997|EG004|Reported Event|Normal Controls: Intervention|Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received the Generic Digital Intervention
11354185|NCT03870997|EG005|Reported Event|Normal Controls:Control|Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received no Digital Intervention
11354186|NCT03869684|BG000|Baseline|Placebo|Placebo: Placebo manufactured to mimic MT-0814
11354187|NCT03869684|BG001|Baseline|MT-0814 Low Dose|"MT-0814 plus placebo~MT-0814: Randomly assigned dose~Placebo: Placebo manufactured to mimic MT-0814"
11354188|NCT03869684|BG002|Baseline|MT-0814 High Dose|MT-0814: Randomly assigned dose
11354189|NCT03869684|BG003|Baseline|Total|Total of all reporting groups
11354190|NCT03869684|FG000|Participant Flow|Placebo|Placebo: Placebo manufactured to mimic MT-0814
11354191|NCT03869684|FG001|Participant Flow|MT-0814 Low Dose|"MT-0814 plus placebo~MT-0814: Randomly assigned dose~Placebo: Placebo manufactured to mimic MT-0814"
11354192|NCT03869684|FG002|Participant Flow|MT-0814 High Dose|MT-0814: Randomly assigned dose
11354193|NCT03869684|OG000|Outcome|Placebo|Placebo: Placebo manufactured to mimic MT-0814
11354194|NCT03869684|OG001|Outcome|MT-0814 Low Dose|"MT-0814 plus placebo~MT-0814: Randomly assigned dose~Placebo: Placebo manufactured to mimic MT-0814"
11354195|NCT03869684|OG002|Outcome|MT-0814 High Dose|MT-0814: Randomly assigned dose
11354196|NCT03869684|EG000|Reported Event|Placebo|Placebo: Placebo manufactured to mimic MT-0814
11354197|NCT03869684|EG001|Reported Event|MT-0814 Low Dose|"MT-0814 plus placebo~MT-0814: Randomly assigned dose~Placebo: Placebo manufactured to mimic MT-0814"
11354198|NCT03869684|EG002|Reported Event|MT-0814 High Dose|MT-0814: Randomly assigned dose
11354199|NCT03861338|BG000|Baseline|Sublocade|"Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg~Sublocade: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction."
11354200|NCT03861338|FG000|Participant Flow|Sublocade|"Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg~Sublocade: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction."
11354201|NCT03861338|OG000|Outcome|Sublocade|"Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg~Sublocade: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction."
11354202|NCT03861338|EG000|Reported Event|Sublocade|"Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg~Sublocade: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction."
11354203|NCT03858335|BG000|Baseline|Constraint-induced Movement Therapy|"Children in constraint-induced movement therapy (CIMT) group will wear forearm splint on the unaffected arm 24 hours for 3 weeks, and receive 15 mCIMT sessions(30-hour dosage)~Constraint-induced movement therapy: The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks."
11354204|NCT03858335|BG001|Baseline|Control|Children in control group will receive only traditional rehab therapies without wearing splint
11354205|NCT03858335|BG002|Baseline|Total|Total of all reporting groups
11354206|NCT03858335|FG000|Participant Flow|Constraint-induced Movement Therapy|"Children in constraint-induced movement therapy (CIMT) group will wear forearm splint on the unaffected arm 24 hours for 3 weeks, and receive 15 mCIMT sessions(30-hour dosage)~Constraint-induced movement therapy: The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks."
11354207|NCT03858335|FG001|Participant Flow|Control|Children in control group will receive only traditional rehab therapies without wearing splint
11354208|NCT03858335|OG000|Outcome|Constraint-induced Movement Therapy|"Children in constraint-induced movement therapy (CIMT) group will wear forearm splint on the unaffected arm 24 hours for 3 weeks, and receive 15 mCIMT sessions(30-hour dosage)~Constraint-induced movement therapy: The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks."
11354209|NCT03858335|OG001|Outcome|Control|Children in control group will receive only traditional rehab therapies without wearing splint
11354210|NCT03858335|EG000|Reported Event|Constraint-induced Movement Therapy|"Children in constraint-induced movement therapy (CIMT) group will wear forearm splint on the unaffected arm 24 hours for 3 weeks, and receive 15 mCIMT sessions(30-hour dosage)~Constraint-induced movement therapy: The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks."
11354211|NCT03858335|EG001|Reported Event|Control|Children in control group will receive only traditional rehab therapies without wearing splint
11354212|NCT03857243|BG000|Baseline|dTDCS Plus Physical Therapy|"active dual transcranial direct current stimulation (TDCS) arm (M1-M1)~dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed."
11354213|NCT03857243|BG001|Baseline|Sham dTDCS Plus Physical Therapy|"Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used.~dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed."
11354214|NCT03857243|BG002|Baseline|Total|Total of all reporting groups
11168177|NCT01985126|EG000|Reported Event|Daratumumab 8 mg/kg|Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
11354215|NCT03857243|FG000|Participant Flow|dTDCS Plus Physical Therapy|"active dual transcranial direct current stimulation (TDCS) arm (M1-M1)~dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed."
11354216|NCT03857243|FG001|Participant Flow|Sham dTDCS Plus Physical Therapy|"Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used.~dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed."
11168178|NCT01985126|EG001|Reported Event|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
11168179|NCT01985321|BG000|Baseline|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
11168180|NCT01985321|BG001|Baseline|Ethanol|36 applications over a 96 hour period
11168181|NCT01985321|BG002|Baseline|Total|Total of all reporting groups
11168182|NCT01985321|FG000|Participant Flow|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
11168183|NCT01985321|FG001|Participant Flow|Ethanol|36 applications over a 96 hour period
10887926|NCT00503906|OG000|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.~Avastin~Gemcitabine~Abraxane"
10887927|NCT00503906|EG000|Reported Event|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
10887928|NCT00503984|BG000|Baseline|Phase 1|"All Phase 1 participants who received at least one dose of the combination of Azacitidine (Aza) and Docetaxel (Doc) and 5mg of Prednisone at one of the starting dose levels:~Level 1: 75 mg/m2 Aza + 60 mg/m2 Doc~Level 2: 75 mg/m2 Aza + 75 mg/m2 Doc~Level 3: 100 mg/m2 Aza + 75 mg/m2 Doc~Level 4: 150 mg/m2 Aza + 75 mg/m2 Doc"
10887929|NCT00503984|BG001|Baseline|Phase 2|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
10887930|NCT00503984|BG002|Baseline|Total|Total of all reporting groups
10887931|NCT00503984|FG000|Participant Flow|Phase 1: Level 1 - 75 Aza + 60 Doc|All Phase 1 participants who received at least one dose starting at the Level 1 dose combination of 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
10887932|NCT00503984|FG001|Participant Flow|Phase 1: Level 2 - 75 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 2 dose combination of 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
10887933|NCT00503984|FG002|Participant Flow|Phase 1: Level 3 - 100 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 3 dose combination of 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
10887934|NCT00503984|FG003|Participant Flow|Phase 1: Level 4 - 150 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 4 dose combination of 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5 mg of Prednisone.
10887935|NCT00503984|FG004|Participant Flow|Phase 2 - Aza + Doc Initial RPTD|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
10887936|NCT00503984|FG005|Participant Flow|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
10887937|NCT00503984|OG000|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
10887938|NCT00503984|OG000|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
10887939|NCT00503984|OG001|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
11168184|NCT01985321|OG000|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
11357278|NCT03761368|OG001|Outcome|Control Group|"Patients from control group had sham Remote Ischemic Preconditioning.~Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min"
11168185|NCT01985321|OG001|Outcome|Ethanol|36 applications over a 96 hour period
11168186|NCT01985321|EG000|Reported Event|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
11168187|NCT01985321|EG001|Reported Event|Ethanol|36 applications over a 96 hour period
11168188|NCT01985334|BG000|Baseline|A1 (Any SABA and/or SAMA)|Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
11168189|NCT01985334|BG001|Baseline|A2 (Glycopyrronium)|Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11354217|NCT03857243|OG000|Outcome|dTDCS Plus Physical Therapy|"active dual transcranial direct current stimulation (TDCS) arm (M1-M1)~dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed."
11354218|NCT03857243|OG001|Outcome|Sham dTDCS Plus Physical Therapy|"Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used.~dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed."
11354219|NCT03857243|EG000|Reported Event|dTDCS Plus Physical Therapy|"active dual transcranial direct current stimulation (TDCS) arm (M1-M1)~dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed."
11354220|NCT03857243|EG001|Reported Event|Sham dTDCS Plus Physical Therapy|"Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used.~dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed."
11354221|NCT03851744|BG000|Baseline|Sea Level First, Then High Altitude|"Carbohydrate metabolism measured at SL, then HA~Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL~7 day washout~High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA"
11354222|NCT03851744|BG001|Baseline|High Altitude, Then Sea Level|"Carbohydrate metabolism measured at HA, then SL~High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA~7 day washout~Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL"
11354223|NCT03851744|BG002|Baseline|Total|Total of all reporting groups
11354224|NCT03851744|FG000|Participant Flow|Sea Level First, Then High Altitude|"Carbohydrate metabolism measured at SL first then HA~Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL~7 day washout~High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA"
11354225|NCT03851744|FG001|Participant Flow|High Altitude First, Then Sea Level|"Carbohydrate metabolism measured at HA first then SL~High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA~7 day washout~Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL"
11354226|NCT03851744|OG000|Outcome|Sea Level|"Carbohydrate metabolism measured at SL~Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL"
11354227|NCT03851744|OG001|Outcome|High Altitude|"Carbohydrate metabolism measured at HA~High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA"
11354228|NCT03851744|EG000|Reported Event|Sea Level|"Carbohydrate metabolism measured at SL~Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL"
11354229|NCT03851744|EG001|Reported Event|High Altitude|"Carbohydrate metabolism measured at HA~High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA"
11354230|NCT03849937|BG000|Baseline|All Direct Care Staff|All staff were encouraged to take the training with a goal of changing the communication culture in each NH. Results are reported for direct care staff, defined as individuals who have daily communication with residents.
11354231|NCT03849937|FG000|Participant Flow|Intervention|"Staff participants at three nursing homes will receive the training and three control nursing homes will complete assessments, but not receive the training.~Changing Talk Online (CHATO): Three, one-hour online training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication strategies."
11354232|NCT03849937|FG001|Participant Flow|Waitlist Control|"After the intervention group takes the training, the waitlist control group of staff participants will crossover and take the training.~Changing Talk Online (CHATO): Three, one-hour online training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication strategies."
11354233|NCT03849937|OG000|Outcome|Intervention|Three nursing homes will receive the training and three control nursing homes will complete assessments, but not receive the training.
11354234|NCT03849937|OG001|Outcome|Waitlist Control|After the intervention group takes the training, the waitlist control group will crossover and take the training.
11354235|NCT03849937|OG000|Outcome|All Direct Care Staff - Pre Training|Pre Training results are reported for direct care staff, defined as individuals who have daily communication with residents.
11354236|NCT03849937|OG001|Outcome|All Direct Care Staff - Post Training|Post Training results are reported for direct care staff, defined as individuals who have daily communication with residents.
11354237|NCT03849937|OG000|Outcome|Intervention|"Three nursing homes will receive the training and three control nursing homes will complete assessments, but not receive the training.~Changing Talk Online (CHATO): Three, one-hour online training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication strategies."
11354238|NCT03849937|OG001|Outcome|Waitlist Control|"After the intervention group takes the training, the waitlist control group will crossover and take the training.~Changing Talk Online (CHATO): Three, one-hour online training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication strategies."
11354239|NCT03849937|OG000|Outcome|Number of Strategies Used to Implement Training|Eight nursing homes were surveyed. Twenty possible implementation strategies were suggested in the toolkit. The number represents the total strategies used to implement the training in each nursing home.
11089729|NCT01524991|FG000|Participant Flow|Treatment|"Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)~Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)~Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)~Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)"
11354240|NCT03849937|OG000|Outcome|Artifacts of Culture Change|NH environment and organizational practice was measured using the Artifacts of Culture Change Tool, a 79-item assessment with six subscales: Care Practice, Environment, Family and Community, Leadership, Workplace Practice, and Staffing Outcomes and Occupancy. Responses for each item range from 0 to 5 depending on the scoring for each question and summed for each subscale; the total score is calculated as a sum of the subscales.
10887940|NCT00503984|OG002|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
10887941|NCT00503984|OG003|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 1: 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
10887942|NCT00503984|OG004|Outcome|Phase 2 - Aza + Doc Initial RPTD|Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
10887943|NCT00503984|OG005|Outcome|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
10887944|NCT00503984|OG000|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m2 of Azacitidine (Aza), 60 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
10887945|NCT00503984|OG001|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
10887946|NCT00503984|OG002|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
10887947|NCT00503984|OG003|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 4: 150 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
10887948|NCT00503984|OG004|Outcome|Phase 2 - Aza + Doc Initial RPTD|Initial Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
10887949|NCT00503984|OG000|Outcome|All Study Participants Achieving PSA Response|All study participants who achieved PSA response to protocol therapy. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.
10887950|NCT00503984|OG000|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
10887951|NCT00503984|OG000|Outcome|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
10887952|NCT00503984|OG001|Outcome|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
10887953|NCT00503984|OG002|Outcome|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
10887954|NCT00503984|OG003|Outcome|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
10887955|NCT00503984|EG000|Reported Event|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
10887956|NCT00503984|EG001|Reported Event|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
10887957|NCT00503984|EG002|Reported Event|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
10887958|NCT00503984|EG003|Reported Event|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
10887959|NCT00503997|BG000|Baseline|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
10887960|NCT00503997|FG000|Participant Flow|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
10887961|NCT00503997|OG000|Outcome|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
11168190|NCT01985334|BG002|Baseline|B1 (Any LAMA or LABA and mMRC=1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
11168191|NCT01985334|BG003|Baseline|B2 (Glycopyrronium and mMRC=1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11168192|NCT01985334|BG004|Baseline|C1 (Any LABA and ICS)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
11168193|NCT01985334|BG005|Baseline|C2 (Indacaterol/Glycopyrronium)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
11231874|NCT02415439|FG005|Participant Flow|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal.
11354241|NCT03849937|EG000|Reported Event|All Direct Care Staff|All staff were encouraged to take the training with a goal of changing the communication culture in each NH. Results are reported for direct care staff, defined as individuals who have daily communication with residents.
11354242|NCT03848416|BG000|Baseline|Ixekizumab (Reference)|Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
11354243|NCT03848416|BG001|Baseline|Ixekizumab (Test 1)|Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
11354244|NCT03848416|BG002|Baseline|Ixekizumab (Test 2)|Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
11354245|NCT03848416|BG003|Baseline|Total|Total of all reporting groups
11354246|NCT03848416|FG000|Participant Flow|Ixekizumab (Reference)|Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe.
11354247|NCT03848416|FG001|Participant Flow|Ixekizumab (Test 1)|Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
11354248|NCT03848416|FG002|Participant Flow|Ixekizumab (Test 2)|Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
11354249|NCT03848416|OG000|Outcome|Ixekizumab (Reference)|Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
11354250|NCT03848416|OG001|Outcome|Ixekizumab (Test 1)|Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
11354251|NCT03848416|OG002|Outcome|Ixekizumab (Test 2)|Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
11354252|NCT03848416|EG000|Reported Event|Ixekizumab (Reference)|Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
11354253|NCT03848416|EG001|Reported Event|Ixekizumab (Test 1)|Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
11354254|NCT03848416|EG002|Reported Event|Ixekizumab (Test 2)|Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
11354255|NCT03847987|BG000|Baseline|Part 1|"Sixteen (16) total participants received each of the following treatments, with a 7-10 day washout period between treatments:~Treatment A = A single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions~Treatment B = A single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions~Treatment C = A single oral dose of RO7017773 (tablet) swallowed whole under fed conditions~Treatment D = A single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions~Treatment sequences were randomly assigned"
11354256|NCT03847987|BG001|Baseline|Part 2|"Eight (8) total participants received each of the following treatments, with a 7-10 day washout period between treatments:~Treatment A (taste assessment) = A single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions~Treatment B (taste assessment) = A single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions~Treatment sequences were randomly assigned"
11354257|NCT03847987|BG002|Baseline|Total|Total of all reporting groups
11354258|NCT03847987|FG000|Participant Flow|Part 1|"Sixteen (16) total participants received each of the following treatments, with a 7-10 day washout period between treatments:~Treatment A = A single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions~Treatment B = A single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions~Treatment C = A single oral dose of RO7017773 (tablet) swallowed whole under fed conditions~Treatment D = A single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions~Treatment sequences were randomly assigned"
11354259|NCT03847987|FG001|Participant Flow|Part 2|"Eight (8) total participants received each of the following treatments, with a 7-10 day washout period between treatments:~Treatment A (taste assessment) = A single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions~Treatment B (taste assessment) = A single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions~Treatment sequences were randomly assigned"
11354260|NCT03847987|OG000|Outcome|Part 1 - Treatment A|Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
11354261|NCT03847987|OG001|Outcome|Part 1 - Treatment B|Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
11354262|NCT03847987|OG002|Outcome|Part 1 - Treatment C|Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
11354263|NCT03847987|OG003|Outcome|Part 1 - Treatment D|Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
11354264|NCT03847987|OG000|Outcome|Part 1 - Treatment D|Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
11354265|NCT03847987|OG000|Outcome|Part 2 - Treatment A|Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
11354266|NCT03847987|OG001|Outcome|Part 2 - Treatment B|Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
11354267|NCT03847987|OG004|Outcome|Part 2 - Treatment A|Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
11354268|NCT03847987|OG005|Outcome|Part 2 - Treatment B|Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
11354269|NCT03847987|EG000|Reported Event|Part 1 - Treatment A|Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
11354270|NCT03847987|EG001|Reported Event|Part 1 - Treatment B|Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
11354271|NCT03847987|EG002|Reported Event|Part 1 - Treatment C|Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
11354272|NCT03847987|EG003|Reported Event|Part 1 - Treatment D|Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
11354273|NCT03847987|EG004|Reported Event|Part 2 - Treatment A|Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
11354274|NCT03847987|EG005|Reported Event|Part 2 - Treatment B|Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
11168194|NCT01985334|BG006|Baseline|D1 (Any LAMA or LABA and mMRC>1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
11168195|NCT01985334|BG007|Baseline|D2 (Indacaterol/Glycopyrronium and mMRC>1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
11168196|NCT01985334|BG008|Baseline|Total|Total of all reporting groups
11168197|NCT01985334|FG000|Participant Flow|A1 (Any SABA and/or SAMA)|Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
11168198|NCT01985334|FG001|Participant Flow|A2 (Glycopyrronium)|Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11168199|NCT01985334|FG002|Participant Flow|B1 (Any LAMA or LABA and mMRC=1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
11168200|NCT01985334|FG003|Participant Flow|B2 (Glycopyrronium and mMRC=1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11168201|NCT01985334|FG004|Participant Flow|C1 (Any LABA and ICS)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
11168202|NCT01985334|FG005|Participant Flow|C2 (Indacaterol/Glycopyrronium)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
11168203|NCT01985334|FG006|Participant Flow|D1 (Any LAMA or LABA and mMRC>1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
11168204|NCT01985334|FG007|Participant Flow|D2 (Indacaterol/Glycopyrronium and mMRC>1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
11168205|NCT01985334|OG000|Outcome|A1 (Any SABA and/or SAMA)|Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
11168206|NCT01985334|OG001|Outcome|A2 (Glycopyrronium)|Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11168207|NCT01985334|OG000|Outcome|B1 (Any LAMA or LABA and mMRC=1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
11168208|NCT01985334|OG001|Outcome|B2 (Glycopyrronium and mMRC=1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11168209|NCT01985334|OG000|Outcome|C1 (Any LABA and ICS)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
11168210|NCT01985334|OG001|Outcome|C2 (Indacaterol/Glycopyrronium)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
11168211|NCT01985334|OG000|Outcome|D1 (Any LAMA or LABA and mMRC>1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
11168212|NCT01985334|OG001|Outcome|D2 (Indacaterol/Glycopyrronium and mMRC>1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
11168213|NCT01985334|OG000|Outcome|A2 + B2|A2 (glycopyrronium)+B2 (glycopyrronium and mMRC=1
11168214|NCT01985334|OG001|Outcome|A1 + B1|A1(any SABA and/or SAMA+B1 (any LAMA or LABA and mMRC=1
11168215|NCT01985334|OG000|Outcome|A2 +B2|A2 (glycopyrronium)+B2 (glycopyrronium and mMRC=1
11168216|NCT01985334|OG001|Outcome|A1 +B1|A1(any SABA and/or SAMA+B1 (any LAMA or LABA and mMRC=1)
11168217|NCT01985334|OG000|Outcome|C2 +D2|C2 (indacaterol/glycopyrronium)+D2 (indacaterol/glycopyrronium and mMRC>1)
11168218|NCT01985334|OG001|Outcome|C1 + D1|C1 (any LABA and ICS)+D1 (any LAMA or LABA and mMRC>1)
11168219|NCT01985334|OG000|Outcome|C2 +D2|C2 (indacaterol/glycopyrronium) + D2 (indacaterol/glycopyrronium and mMRC>1)
11168220|NCT01985334|OG001|Outcome|C1 + D1|C1 (any LABA and ICS) + D1 (any LAMA or LABA and mMRC>1)
11168221|NCT01985334|OG002|Outcome|B1 (Any LAMA or LABA and mMRC=1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
11168222|NCT01985334|OG003|Outcome|B2 (Glycopyrronium and mMRC=1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11168223|NCT01985334|OG004|Outcome|C1 (Any LABA and ICS)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
11231875|NCT02415439|FG006|Participant Flow|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
11231876|NCT02415439|FG007|Participant Flow|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
11354275|NCT03854253|BG000|Baseline|Long Introducer 6Fr-25cm|"The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm~Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm"
11354276|NCT03854253|BG001|Baseline|Short Introducer 6Fr-10cm|"The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm~Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm"
11354277|NCT03854253|BG002|Baseline|Total|Total of all reporting groups
11354278|NCT03854253|FG000|Participant Flow|Long Introducer 6Fr-25cm|"The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm~Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm"
11354279|NCT03854253|FG001|Participant Flow|Short Introducer 6Fr-10cm|"The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm~Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm"
11354280|NCT03854253|OG000|Outcome|Long Introducer 6Fr-25cm|"The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm~Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm"
11354281|NCT03854253|OG001|Outcome|Short Introducer 6Fr-10cm|"The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm~Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm"
11354282|NCT03854253|EG000|Reported Event|Long Introducer 6Fr-25cm|"The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm~Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm"
11354283|NCT03854253|EG001|Reported Event|Short Introducer 6Fr-10cm|"The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm~Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm"
11354284|NCT03870737|BG000|Baseline|Active TNS|"Participants who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition.~Active TNS: Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study."
11354285|NCT03870737|FG000|Participant Flow|Active TNS|"Participants who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition.~Active TNS: Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study."
11354286|NCT03870737|OG000|Outcome|Active TNS|"Participants who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition.~Active TNS: Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study."
11354287|NCT03870737|EG000|Reported Event|Active TNS|"Participants who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition.~Active TNS: Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study."
11354288|NCT03860181|BG000|Baseline|Traditional Dermabond + Subcuticular Sutures - Surgeon 1|"Subcuticular sutures with traditional Dermabond applied to incision.~Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures."
11354289|NCT03860181|BG001|Baseline|Metal Staples - Surgeon 2|"Metal staples~Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,"
11354290|NCT03860181|BG002|Baseline|Dermabond PRINEO - Surgeon 1|"Dermabond PRINEO System~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354291|NCT03860181|BG003|Baseline|Dermabond PRINEO - Surgeon 2|"Dermabond PRINEO System~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354292|NCT03860181|BG004|Baseline|Total|Total of all reporting groups
11354293|NCT03860181|FG000|Participant Flow|Traditional Dermabond + Subcuticular Sutures - Surgeon 1|"Subcuticular sutures with traditional Dermabond applied to incision.~Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures."
11354294|NCT03860181|FG001|Participant Flow|Metal Staples - Surgeon 2|"Metal staples~Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,"
11354295|NCT03860181|FG002|Participant Flow|Dermabond PRINEO - Surgeon 1|"Dermabond PRINEO System~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354296|NCT03860181|FG003|Participant Flow|Dermabond PRINEO - Surgeon 2|"Dermabond PRINEO System~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354297|NCT03860181|OG000|Outcome|Traditional Dermabond + Subcuticular Sutures - Surgeon 1|"Subcuticular sutures with traditional Dermabond applied to incision.~Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures."
11354298|NCT03860181|OG001|Outcome|Metal Staples - Surgeon 2|"Metal staples~Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,"
11354299|NCT03860181|OG002|Outcome|Dermabond PRINEO - Surgeon 1|"Dermabond PRINEO System~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354300|NCT03860181|OG003|Outcome|Dermabond PRINEO - Surgeon 2|"Dermabond PRINEO System~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354301|NCT03860181|OG000|Outcome|Traditional Dermabond + Subcuticular Sutures - Surgeon 1|"Subcuticular sutures with traditional Dermabond applied to incision.~Subcuticular Sutures - Surgeon 1: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures."
11354302|NCT03860181|OG001|Outcome|Metal Staples - Surgeon 2|"Metal staples~Metal Staples - Surgeon 2: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,"
11354303|NCT03860181|OG002|Outcome|Dermabond PRINEO - Surgeon 1|"Dermabond PRINEO System~PRINEO - Surgeon 1: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354304|NCT03860181|OG003|Outcome|Dermabond PRINEO - Surgeon 2|"Dermabond PRINEO System~PRINEO - Surgeon 2: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354305|NCT03860181|OG000|Outcome|Traditional Dermabond + Subcuticular Sutures - Patient Scores|"Patients that received the subcuticular sutures with traditional Dermabond applied for their incision intervention.~Subcuticular Sutures: The intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond. The deep layer closure will require interrupted sutures."
11354306|NCT03860181|OG001|Outcome|Traditional Dermabond + Subcuticular Sutures - Surgeon 1 Scores|Surgeon 1 scores for patients who received Subcuticular sutures with traditional Dermabond applied to incision.
11354307|NCT03860181|OG002|Outcome|Metal Staples - Patient Scores|"Patients that received the metal staples intervention for their wound closure.~Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures."
11231877|NCT02415439|FG008|Participant Flow|VBP15- 1.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
11231878|NCT02415439|FG009|Participant Flow|VBP15- 3.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
11231879|NCT02415439|FG010|Participant Flow|VBP15- 9.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
11231880|NCT02415439|FG011|Participant Flow|VBP15- 20 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
11231881|NCT02415439|FG012|Participant Flow|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions.
11231882|NCT02415439|OG000|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
11231883|NCT02415439|OG001|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
11231884|NCT02415439|OG002|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
11231885|NCT02415439|OG003|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
11231886|NCT02415439|OG004|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
11231887|NCT02415439|OG005|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
11231888|NCT02415439|OG006|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
11231889|NCT02415439|OG007|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
11231890|NCT02415439|OG000|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
11231891|NCT02415439|OG004|Outcome|VBP15- 8.0 mg/kg Fasted SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
11231892|NCT02415439|OG000|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
11231893|NCT02415439|OG001|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
11231894|NCT02415439|OG002|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
11231895|NCT02415439|OG003|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
11231896|NCT02415439|OG004|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
11231897|NCT02415439|EG000|Reported Event|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
11231898|NCT02415439|EG001|Reported Event|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
11231899|NCT02415439|EG002|Reported Event|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
11231900|NCT02415439|EG003|Reported Event|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
11231901|NCT02415439|EG004|Reported Event|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
11231902|NCT02415439|EG005|Reported Event|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
11231903|NCT02415439|EG006|Reported Event|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
11231904|NCT02415439|EG007|Reported Event|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
11231905|NCT02415439|EG008|Reported Event|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
11231906|NCT02415439|EG009|Reported Event|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
11231907|NCT02415439|EG010|Reported Event|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
11231908|NCT02415439|EG011|Reported Event|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
11231909|NCT02415439|EG012|Reported Event|Placebo MAD|Subjects were orally administered a dose of placebo daily for 14 days under fasted conditions.
11231910|NCT02415595|BG000|Baseline|BMS-955176/GSK3532795 60 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.
11231911|NCT02415595|BG001|Baseline|BMS-955176/GSK3532795 120 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.
11354308|NCT03860181|OG003|Outcome|Metal Staples - Surgeon 2 Scores|Surgeon 2 Scores for patients that received metal staples.
11168224|NCT01985334|OG005|Outcome|C2 (Indacaterol/Glycopyrronium)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
11168225|NCT01985334|OG006|Outcome|D1 (Any LAMA or LABA and mMRC>1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
11168226|NCT01985334|OG007|Outcome|D2 (Indacaterol/Glycopyrronium and mMRC>1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
11168227|NCT01985334|EG000|Reported Event|A1 (Any SABA and/or SAMA)|Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
11168228|NCT01985334|EG001|Reported Event|A2 (Glycopyrronium)|Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11168229|NCT01985334|EG002|Reported Event|B1 (Any LAMA or@ LABA and mMRC eq 1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
11168230|NCT01985334|EG003|Reported Event|B2 (Glycopyrronium@ and mMRC eq 1)|Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
11168231|NCT01985334|EG004|Reported Event|C1 (Any LABA and ICS)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
11168232|NCT01985334|EG005|Reported Event|C2 (Indacaterol/@Glycopyrronium)|Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
11168233|NCT01985334|EG006|Reported Event|D1 (Any LAMA or@ LABA and mMRC gt 1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
11168234|NCT01985334|EG007|Reported Event|D2 (Indacaterol/@Glycopyrronium and@ mMRC gt 1)|Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
11168235|NCT01985360|BG000|Baseline|Invasive Strategy (INV)|"Routine invasive strategy with cardiac catheterization followed by revascularization + optimal medical therapy.~Cardiac Catheterization: Narrowed blood vessels can be opened without surgery using stents or bypassed with surgery. The doctor will examine blood vessels to determine the location and extent of narrowings.~Coronary Artery Bypass Graft Surgery (CABG): Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This creates new routes around narrowed/blocked heart arteries.~Percutaneous Coronary Intervention: A small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.~Lifestyle: Diet, physical activity, smoking cessation Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies"
11168236|NCT01985360|BG001|Baseline|Conservative Strategy (CON)|"Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with OMT failure.~Lifestyle: Diet, physical activity, smoking cessation~Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies"
11168237|NCT01985360|BG002|Baseline|Total|Total of all reporting groups
11168238|NCT01985360|FG000|Participant Flow|Invasive Strategy (INV)|"Routine invasive strategy with cardiac catheterization followed by revascularization + optimal medical therapy.~Cardiac Catheterization: Narrowed blood vessels can be opened without surgery using stents or bypassed with surgery. The doctor will examine blood vessels to determine the location and extent of narrowings.~Coronary Artery Bypass Graft Surgery (CABG): Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This creates new routes around narrowed/blocked heart arteries.~Percutaneous Coronary Intervention: A small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.~Lifestyle: Diet, physical activity, smoking cessation Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies"
11168239|NCT01985360|FG001|Participant Flow|Conservative Strategy (CON)|"Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with OMT failure.~Lifestyle: Diet, physical activity, smoking cessation~Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies"
11168240|NCT01985360|OG000|Outcome|Invasive Strategy|Invasive Strategy
11168241|NCT01985360|OG001|Outcome|Conservative Strategy|Conservative Strategy
11168242|NCT01985360|EG000|Reported Event|Invasive Strategy|Invasive Strategy
11168243|NCT01985360|EG001|Reported Event|Conservative Strategy|Conservative Strategy
11168244|NCT01985425|BG000|Baseline|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
11168245|NCT01985425|BG001|Baseline|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
11168246|NCT01985425|BG002|Baseline|Total|Total of all reporting groups
11168247|NCT01985425|FG000|Participant Flow|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
11231912|NCT02415595|BG002|Baseline|BMS-955176/GSK3532795 180 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
11231913|NCT02415595|BG003|Baseline|EFV 600 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
11231914|NCT02415595|BG004|Baseline|Total|Total of all reporting groups
11231915|NCT02415595|FG000|Participant Flow|BMS-955176/GSK3532795 60 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.
11231916|NCT02415595|FG001|Participant Flow|BMS-955176/GSK3532795 120 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.
11231917|NCT02415595|FG002|Participant Flow|BMS-955176/GSK3532795 180 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
11231918|NCT02415595|FG003|Participant Flow|EFV 600 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
11231919|NCT02415595|OG000|Outcome|BMS-955176/GSK3532795 60 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.
11231920|NCT02415595|OG001|Outcome|BMS-955176/GSK3532795 120 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.
11231921|NCT02415595|OG002|Outcome|BMS-955176/GSK3532795 180 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
11231922|NCT02415595|OG003|Outcome|EFV 600 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
11231923|NCT02415595|OG000|Outcome|BMS-955176/GSK3532795 60 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.
11231924|NCT02415595|EG000|Reported Event|BMS-955176/GSK3532795 60 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.
11231925|NCT02415595|EG001|Reported Event|BMS-955176/GSK3532795 120 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.
11168248|NCT01985425|FG001|Participant Flow|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
11168249|NCT01985425|OG000|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
11168250|NCT01985425|OG001|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
11168251|NCT01985425|EG000|Reported Event|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
11168252|NCT01985425|EG001|Reported Event|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
11168253|NCT01985542|BG000|Baseline|Subcutaneous Immunotherapy|Starting with subcutaneuous birch pollen immunotherapy with normal protocol of the Hospital
11168254|NCT01985542|BG001|Baseline|no Immunotherapy|Birch pollen allergic subjects that are not starting with immunotherapy
11168255|NCT01985542|BG002|Baseline|Total|Total of all reporting groups
11168256|NCT01985542|FG000|Participant Flow|Subcutaneous Immunotherapy|"Starts with birch pollen subcutaneous immunotherapy~birch pollen subcutaneous immunotherapy: birch pollen subcutaneous immunotherapy"
11168257|NCT01985542|FG001|Participant Flow|no Immunotherapy|not starting with birch pollen subcutaneous immunotherapy
11168258|NCT01985542|OG000|Outcome|Subcutaneous Immunotherapy|Subjects with birch pollen allergic rhinitis.
11168259|NCT01985542|OG001|Outcome|No Immunotherapy|Subjects with birch pollen allergic rhinitis.
11168260|NCT01985542|OG000|Outcome|Immunotherapy|Subjects with birch pollen allergic rhinitis.
11168261|NCT01985542|EG000|Reported Event|Subcutaneous Immunotherapy|"Starts with birch pollen subcutaneous immunotherapy~birch pollen subcutaneous immunotherapy: birch pollen subcutaneous immunotherapy"
11168262|NCT01985542|EG001|Reported Event|no Immunotherapy|not starting with birch pollen subcutaneous immunotherapy
11168263|NCT01985581|BG000|Baseline|PLB First Then GXR|subjects received PLB in first arm of study and GXR in second arm. subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
11168264|NCT01985581|BG001|Baseline|GXR First Then PLB|subjects received GXR in first arm of study and PLB in second arm subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
11168265|NCT01985581|BG002|Baseline|Total|Total of all reporting groups
11168266|NCT01985581|FG000|Participant Flow|Placebo First Then GXR|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and placebo for the first intervention period and GXR for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
11168267|NCT01985581|FG001|Participant Flow|GXR First Then Placebo|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and GXR for the first intervention period and placebo for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
11168268|NCT01985581|OG000|Outcome|Placebo and Stimulant|Subjects received placebo and usual stimulant therapy
11168269|NCT01985581|OG001|Outcome|GXR and Stimulant|Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
11168270|NCT01985581|OG000|Outcome|Placebo and Stimulant|The quality of life was measured in those patients taking placebo along with their usual stimulant therapy
11168271|NCT01985581|OG001|Outcome|GXR and Stimulant|The quality of life was measured in those patients taking GXR along with their usual stimulant therapy
11168272|NCT01985581|OG000|Outcome|Placebo and Stimulant|subjects continued to take usual dose stimulant and took placebo
11168273|NCT01985581|OG001|Outcome|GXR and Stimulant|Patients continued to take usual dose stimulant and optimized dose (1-4mg) of GXR
11168274|NCT01985581|OG000|Outcome|Stimulant & Placebo|"patient will continue to take stable dosage of usual stimulant(Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)therapy plus placebo~Placebo"
11168275|NCT01985581|OG001|Outcome|Stimulant and Guanfancine Extended Release|"patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and also receive guanfacine extended release at a individually optimized dosage of 1-4 mg.~Guanfacine extended release"
11168276|NCT01985581|OG000|Outcome|Placebo and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and placebo
11168277|NCT01985581|OG001|Outcome|GXR and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and GXR (optimized dose 1-4 mg)
11168278|NCT01985581|OG000|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
11168279|NCT01985581|OG001|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR at optimized dose of 1-4 mg
11231926|NCT02415595|EG002|Reported Event|BMS-955176/GSK3532795 180 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
11231927|NCT02415595|EG003|Reported Event|EFV 600 mg + TDF/FTC|Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
11231928|NCT02415608|BG000|Baseline|Ibrutinib 420 mg/Day|"Participants receive ibrutinib daily on days 1 to 28, at 420 mg/day in 28-day cycles~Ibrutinib: Given orally"
11231929|NCT02415608|BG001|Baseline|Ibrutinib 560 mg/Day|"Participants receive ibrutinib daily on days 1 to 28, at 560 mg/day in 28-day cycles~Ibrutinib: Given orally"
11231930|NCT02415608|BG002|Baseline|Total|Total of all reporting groups
11231931|NCT02415608|FG000|Participant Flow|Ibrutinib 420 mg/Day|"Participants receive ibrutinib daily on days 1 to 28, at 420 mg/day in 28-day cycles~Ibrutinib: Given orally"
11231932|NCT02415608|FG001|Participant Flow|Ibrutinib 560 mg/Day|"Participants receive ibrutinib daily on days 1 to 28, at 560 mg/day in 28-day cycles~Ibrutinib: Given orally"
11231933|NCT02415608|OG000|Outcome|Ibrutinib 420 mg/Day|"Participants receive ibrutinib daily on days 1 to 28, at 420 mg/day in 28-day cycles~Ibrutinib: Given orally"
11231934|NCT02415608|OG001|Outcome|Ibrutinib 560 mg/Day|"Participants receive ibrutinib daily on days 1 to 28, at 560 mg/day in 28-day cycles~Ibrutinib: Given orally"
11231935|NCT02415608|EG000|Reported Event|Ibrutinib 420 mg/Day|"Participants receive ibrutinib daily on days 1 to 28, at 420 mg/day in 28-day cycles~Ibrutinib: Given orally"
11231936|NCT02415608|EG001|Reported Event|Ibrutinib 560 mg/Day|"Participants receive ibrutinib daily on days 1 to 28, at 560 mg/day in 28-day cycles~Ibrutinib: Given orally"
11231937|NCT02415842|BG000|Baseline|H1N1_AS|Subjects 19-40 years of age (in H1N1 cohort of primary completed study Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
11231938|NCT02415842|BG001|Baseline|H1N1_NAS|Subjects 19-40 years of age (in H1N1 cohort of primary completed study -Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
11231939|NCT02415842|BG002|Baseline|H5N1_AS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
11231940|NCT02415842|BG003|Baseline|H5N1_NAS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21
11231941|NCT02415842|BG004|Baseline|H9N2_AS|Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
11231942|NCT02415842|BG005|Baseline|H9N2_NAS|Subjects 18-64 years of age (in H9N2 cohort of primary completed studyQ-PAN H9N2-001 (116358)(A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and with saline placebo at Day 182.
11231943|NCT02415842|BG006|Baseline|DQIV_NAS|Subjects 18-≤39 years of age (in D-QIV cohort of primary completed study FLU D-QIV-015 (201251) (A/Christchurch/16/2010 (H1N1)pdm09, A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012, B/Brisbane/60/2008)) who were administered 15 µg HA (no AS) of each of 4 strains (total 60 µg HA) at Day 0.
11231944|NCT02415842|BG007|Baseline|QPAN5_C|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
11231945|NCT02415842|BG008|Baseline|QPAN5_G|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
11231946|NCT02415842|BG009|Baseline|H5N1_VT|Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
11231947|NCT02415842|BG010|Baseline|H5N1_IN|Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration (3.8 µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration (3.8 µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12
11231948|NCT02415842|BG011|Baseline|H5N1_PAS|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03B) pandemic vaccine with 1.9 µg HA (hemagglutinin) at Days 0 and 21.
11231949|NCT02415842|BG012|Baseline|H5N1_PCN|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered placebo at Days 0 and 21.
11231950|NCT02415842|BG013|Baseline|Total|Total of all reporting groups
11231951|NCT02415842|FG000|Participant Flow|H1N1_AS|Subjects 19-40 years of age (in H1N1 cohort of primary completed study Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
11231952|NCT02415842|FG001|Participant Flow|H1N1_NAS|Subjects 19-40 years of age (in H1N1 cohort of primary completed study -Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
11354309|NCT03860181|OG004|Outcome|Dermabond PRINEO - Surgeon 1 Patient Scores|"Patients that received the Dermabond PRINEO System intervention for wound closure from Surgeon 1.~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354310|NCT03860181|OG005|Outcome|Dermabond PRINEO - Surgeon 1 Scores|Surgeon 1 Scores for patients that received the Dermabond PRINEO closure system.
11354311|NCT03860181|OG006|Outcome|Dermabond PRINEO - Surgeon 2 Patient Scores|"Patients that received the Dermabond PRINEO System intervention wound closure from Surgeon 2.~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354312|NCT03860181|OG007|Outcome|Dermabond PRINEO - Surgeon 2 Scores|Surgeon 2 Scores for patients that received the Dermabond PRINEO closure system.
11354313|NCT03860181|EG000|Reported Event|Traditional Dermabond + Subcuticular Sutures|"Subcuticular sutures with traditional Dermabond applied to incision.~Subcuticular Sutures: This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures."
11354314|NCT03860181|EG001|Reported Event|Metal Staples|"Metal staples~Metal Staples: This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,"
11354315|NCT03860181|EG002|Reported Event|Dermabond PRINEO|"Dermabond PRINEO System~PRINEO: The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer."
11354316|NCT03856944|BG000|Baseline|ReSTOR Toric|"Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation.~ReSTOR Toric: ReSTOR Toric bilateral IOL implantation"
11354317|NCT03856944|FG000|Participant Flow|ReSTOR Toric|"Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation.~ReSTOR Toric: ReSTOR Toric bilateral IOL implantation"
11354318|NCT03856944|OG000|Outcome|ReSTOR Toric|"Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation.~ReSTOR Toric: ReSTOR Toric bilateral IOL implantation"
11354319|NCT03856944|EG000|Reported Event|ReSTOR Toric|"Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation.~ReSTOR Toric: ReSTOR Toric bilateral IOL implantation"
11354320|NCT03853551|BG000|Baseline|Single Arm|single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
11354321|NCT03853551|FG000|Participant Flow|Single Arm|single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
11354322|NCT03853551|OG000|Outcome|Single Arm|single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
11168280|NCT01985581|OG001|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR (optimized dose 1-4 mg)
11354323|NCT03853551|EG000|Reported Event|Single Arm|single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
11354324|NCT03870555|BG000|Baseline|Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg|"Period 1: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.~Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg infusion, intravenously, once on Day 2.~Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg infusion, intravenously, once on Day 2.~A washout period of at least 16 days was maintained between each Treatment Period."
11354325|NCT03870555|BG001|Baseline|Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg|"Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg infusion, intravenously once on Day 2.~Period 2: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.~Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg, infusion, intravenously, once on Day 2.~A washout period of at least 16 days was maintained between each Treatment Period."
11354326|NCT03870555|BG002|Baseline|Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo|"Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg, infusion, intravenously once on Day 2.~Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg, infusion, intravenously, once on Day 2.~Period 3: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.~A washout period of at least 16 days was maintained between each Treatment Period."
11354327|NCT03870555|BG003|Baseline|Total|Total of all reporting groups
11354328|NCT03870555|FG000|Participant Flow|Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg|"Period 1: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.~Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg infusion, intravenously, once on Day 2.~Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg infusion, intravenously, once on Day 2.~A washout period of at least 16 days was maintained between each Treatment Period."
11354329|NCT03870555|FG001|Participant Flow|Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg|"Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg infusion, intravenously once on Day 2.~Period 2: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.~Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg, infusion, intravenously, once on Day 2.~A washout period of at least 16 days was maintained between each Treatment Period."
11357279|NCT03761368|EG000|Reported Event|RIPC Group|"The RIPC group underwent Remote Ischemic Preconditioning.~Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper-arm cuff"
11354330|NCT03870555|FG002|Participant Flow|Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo|"Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg, infusion, intravenously once on Day 2.~Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg, infusion, intravenously, once on Day 2.~Period 3: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.~A washout period of at least 16 days was maintained between each Treatment Period."
11354331|NCT03870555|OG000|Outcome|Treatment Dose: TAK-954 0.5 mg|TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
11354332|NCT03870555|OG001|Outcome|Treatment Dose: TAK-954 1 mg|TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
11354333|NCT03870555|OG002|Outcome|Treatment Dose: TAK-954 2 mg|TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
11354334|NCT03870555|EG000|Reported Event|Lead-in Dose: TAK-954 0.1 mg|TAK-954 0.1 mg, infusion, intravenously, once on Day 1 of Period 1, 2 or 3 in Sequence 1, 2, or 3.
11354335|NCT03870555|EG001|Reported Event|Lead-in Dose: Placebo|TAK-954 placebo-matching, infusion, intravenously, once on Day 1 of Period 1, 2, or 3 in Sequence 1, 2, or 3.
11354336|NCT03870555|EG002|Reported Event|Treatment Dose: TAK-954 0.5 mg|TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
11354337|NCT03870555|EG003|Reported Event|Treatment Dose: TAK-954 1 mg|TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
11354338|NCT03870555|EG004|Reported Event|Treatment Dose: TAK-954 2 mg|TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
11354339|NCT03870555|EG005|Reported Event|Treatment Dose: Placebo|TAK-954 placebo-matching, infusion, intravenously once on Day 2 of Period 1, 2 and 3.
11354340|NCT03861845|BG000|Baseline|Standard Off-the-shelf Pillbox|"Participants will engage in reflection on medication routines. Then they will receive a standard off-the-shelf pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354341|NCT03861845|BG001|Baseline|Custom Off-the-shelf|"Participants will engage in reflection on medication routines. Then they will receive a custom off-the-shelf pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Custom off-the-shelf pillbox: Then the participant will be administered an off-the-shelf pillbox that was purchased specifically for the participant's preferences, routine, medication regimen, and skills/abilities.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354342|NCT03861845|BG002|Baseline|Custom Designed and Manufactured|"Participants will engage in reflection on medication routines. Then they will receive a custom designed and manufactured pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Custom designed and manufactured pillbox: Then the participant will describe any design preferences for the pillbox. The researcher will design and manufacture the pillbox using a 3D printer, publically available 3D printing object repository, and computer aided design software.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354343|NCT03861845|BG003|Baseline|Total|Total of all reporting groups
11354344|NCT03861845|FG000|Participant Flow|Standard Off-the-shelf Pillbox|"Participants will engage in reflection on medication routines. Then they will receive a standard off-the-shelf pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11168281|NCT01985581|EG000|Reported Event|Stimulant and GXR|adverse event frequency in those taking stimulant + GXR
11357280|NCT03761368|EG001|Reported Event|Control Group|"Patients from control group had sham Remote Ischemic Preconditioning.~Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min"
11357281|NCT03761147|BG000|Baseline|Paula Method|Paula exercises: structured exercises aimed to stimulate ring muscles
11357282|NCT03761147|BG001|Baseline|Standard of Care|Standard of Care
11357283|NCT03761147|BG002|Baseline|Total|Total of all reporting groups
11357284|NCT03761147|FG000|Participant Flow|Paula Method|Paula exercises: structured exercises aimed to stimulate ring muscles
11231953|NCT02415842|FG002|Participant Flow|H5N1_AS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
11231954|NCT02415842|FG003|Participant Flow|H5N1_NAS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21
11231955|NCT02415842|FG004|Participant Flow|H9N2_AS|Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
11231956|NCT02415842|FG005|Participant Flow|H9N2_NAS|Subjects 18-64 years of age (in H9N2 cohort of primary completed studyQ-PAN H9N2-001 (116358)(A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and with saline placebo at Day 182.
11231957|NCT02415842|FG006|Participant Flow|DQIV_NAS|Subjects 18-≤39 years of age (in D-QIV cohort of primary completed study FLU D-QIV-015 (201251) (A/Christchurch/16/2010 (H1N1)pdm09, A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012, B/Brisbane/60/2008)) who were administered 15 µg HA (no AS) of each of 4 strains (total 60 µg HA) at Day 0.
11231958|NCT02415842|FG007|Participant Flow|QPAN5_C|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
11231959|NCT02415842|FG008|Participant Flow|QPAN5_G|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
11231960|NCT02415842|FG009|Participant Flow|H5N1_VT|Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
11231961|NCT02415842|FG010|Participant Flow|H5N1_IN|Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration (3.8 µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration (3.8 µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12
11231962|NCT02415842|FG011|Participant Flow|H5N1_PAS|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03B) pandemic vaccine with 1.9 µg HA (hemagglutinin) at Days 0 and 21.
11231963|NCT02415842|FG012|Participant Flow|H5N1_PCN|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered placebo at Days 0 and 21.
11231964|NCT02415842|OG000|Outcome|H1N1_AS|Subjects 19-40 years of age (in H1N1 cohort of primary completed study Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
11231965|NCT02415842|OG001|Outcome|H1N1_NAS|Subjects 19-40 years of age (in H1N1 cohort of primary completed study -Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
11231966|NCT02415842|OG002|Outcome|H5N1_AS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
11231967|NCT02415842|OG003|Outcome|H5N1_NAS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21
11231968|NCT02415842|OG004|Outcome|H9N2_AS|Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
11231969|NCT02415842|OG005|Outcome|H9N2_NAS|Subjects 18-64 years of age (in H9N2 cohort of primary completed studyQ-PAN H9N2-001 (116358)(A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and with saline placebo at Day 182.
11231970|NCT02415842|OG000|Outcome|H5N1_PAS|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03B) pandemic vaccine with 1.9 µg HA (hemagglutinin) at Days 0 and 21
11231971|NCT02415842|OG001|Outcome|H5N1_PCN|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered placebo at Days 0 and 21
11231972|NCT02415842|OG000|Outcome|QPAN5_C|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
11231973|NCT02415842|OG001|Outcome|QPAN5_G|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549
11231974|NCT02415842|OG001|Outcome|QPAN5_G|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
11357285|NCT03761147|FG001|Participant Flow|Standard of Care|Standard of Care
11354345|NCT03861845|FG001|Participant Flow|Custom Off-the-shelf|"Participants will engage in reflection on medication routines. Then they will receive a custom off-the-shelf pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Custom off-the-shelf pillbox: Then the participant will be administered an off-the-shelf pillbox that was purchased specifically for the participant's preferences, routine, medication regimen, and skills/abilities.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354346|NCT03861845|FG002|Participant Flow|Custom Designed and Manufactured|"Participants will engage in reflection on medication routines. Then they will receive a custom designed and manufactured pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Custom designed and manufactured pillbox: Then the participant will describe any design preferences for the pillbox. The researcher will design and manufacture the pillbox using a 3D printer, publically available 3D printing object repository, and computer aided design software.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354347|NCT03861845|OG000|Outcome|Standard Off-the-shelf Pillbox|"Participants will engage in reflection on medication routines. Then they will receive a standard off-the-shelf pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354348|NCT03861845|OG001|Outcome|Custom Off-the-shelf|"Participants will engage in reflection on medication routines. Then they will receive a custom off-the-shelf pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Custom off-the-shelf pillbox: Then the participant will be administered an off-the-shelf pillbox that was purchased specifically for the participant's preferences, routine, medication regimen, and skills/abilities.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354349|NCT03861845|OG002|Outcome|Custom Designed and Manufactured|"Participants will engage in reflection on medication routines. Then they will receive a custom designed and manufactured pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Custom designed and manufactured pillbox: Then the participant will describe any design preferences for the pillbox. The researcher will design and manufacture the pillbox using a 3D printer, publically available 3D printing object repository, and computer aided design software.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354350|NCT03861845|EG000|Reported Event|Standard Off-the-shelf Pillbox|"Participants will engage in reflection on medication routines. Then they will receive a standard off-the-shelf pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354351|NCT03861845|EG001|Reported Event|Custom Off-the-shelf|"Participants will engage in reflection on medication routines. Then they will receive a custom off-the-shelf pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Custom off-the-shelf pillbox: Then the participant will be administered an off-the-shelf pillbox that was purchased specifically for the participant's preferences, routine, medication regimen, and skills/abilities.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11357286|NCT03761147|OG000|Outcome|Paula Method|Paula exercises: structured exercises aimed to stimulate ring muscles
11357287|NCT03761147|OG001|Outcome|Standard of Care|Standard of Care
11357288|NCT03761147|EG000|Reported Event|Paula Method|Paula exercises: structured exercises aimed to stimulate ring muscles
11357289|NCT03761147|EG001|Reported Event|Standard of Care|Standard of Care
11357290|NCT03760913|BG000|Baseline|Placebo Part A, Single Ascending Dose|Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo
11357291|NCT03760913|BG001|Baseline|30 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng
11168282|NCT01985581|EG001|Reported Event|Stimulant and PLB|adverse event frequency in those taking stimulant + PLB
11168283|NCT01985685|BG000|Baseline|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
11168284|NCT01985685|BG001|Baseline|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
11168285|NCT01985685|BG002|Baseline|Total|Total of all reporting groups
11168286|NCT01985685|FG000|Participant Flow|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
11168287|NCT01985685|FG001|Participant Flow|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
11168288|NCT01985685|OG000|Outcome|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
11168289|NCT01985685|OG001|Outcome|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
11168290|NCT01985685|EG000|Reported Event|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
11168291|NCT01985685|EG001|Reported Event|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
11168292|NCT01985763|BG000|Baseline|Genistein|Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
11168293|NCT01985763|FG000|Participant Flow|Genistein|Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
11168294|NCT01985763|OG000|Outcome|Genistein|Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
11168295|NCT01985763|EG000|Reported Event|Genistein|Genistein 60mg/day orally for 4 days before chemotherapy.
11168296|NCT01985763|EG001|Reported Event|Genistein and Chemotherapy|Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to chemotherapy.
11168297|NCT01985932|BG000|Baseline|Functional MRI|"Subjects in this arm receive functional MRI during radiation therapy treatment planning.~MRI"
11168298|NCT01985932|FG000|Participant Flow|Functional MRI|"Subjects in this arm receive functional MRI during radiation therapy treatment planning.~MRI"
11168299|NCT01985932|OG000|Outcome|Functional MRI|"Subjects in this arm receive functional MRI during radiation therapy treatment planning.~MRI"
11168300|NCT01985932|EG000|Reported Event|Functional MRI|"Subjects in this arm receive functional MRI during radiation therapy treatment planning.~MRI"
11168301|NCT01985958|BG000|Baseline|Single Arm|"In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.~Radiation therapy"
11168302|NCT01985958|FG000|Participant Flow|Single Arm|"In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.~Radiation therapy"
11168303|NCT01985958|OG000|Outcome|Single Arm|"In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.~Radiation therapy"
11168304|NCT01985958|EG000|Reported Event|Single Arm|"In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.~Radiation therapy"
11168305|NCT01985971|BG000|Baseline|EF5 PET/CT Imaging|PET/CT Imaging
11168306|NCT01985971|FG000|Participant Flow|F18 EF5 PET/CT Imaging|PET/CT Imaging
11168307|NCT01985971|OG000|Outcome|EF5 PET/CT Imaging|PET/CT Imaging
11354352|NCT03861845|EG002|Reported Event|Custom Designed and Manufactured|"Participants will engage in reflection on medication routines. Then they will receive a custom designed and manufactured pillbox. Finally, the participants will receive education & training on how to use the pillbox.~Custom designed and manufactured pillbox: Then the participant will describe any design preferences for the pillbox. The researcher will design and manufacture the pillbox using a 3D printer, publically available 3D printing object repository, and computer aided design software.~Education & Training: The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.~Reflection on medication routines: The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task."
11354353|NCT03851094|BG000|Baseline|Standard of Care (Group A)|Standard of care procedures for new CPAP patients were followed.
11354354|NCT03851094|BG001|Baseline|Wellth App (Group B)|Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
11354355|NCT03851094|BG002|Baseline|Total|Total of all reporting groups
11354356|NCT03851094|FG000|Participant Flow|Standard of Care (Group A)|Standard of care procedures for new CPAP patients were followed.
11354357|NCT03851094|FG001|Participant Flow|Wellth App (Group B)|Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
11354358|NCT03851094|OG000|Outcome|Standard of Care (Group A)|Standard of care procedures for a new CPAP patient were applied.
11354359|NCT03851094|OG001|Outcome|Wellth App (Group B)|Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
11354360|NCT03851094|OG000|Outcome|Standard of Care (Group A)|Standard of care procedures for new CPAP patients were followed.
11354361|NCT03851094|OG001|Outcome|Wellth App (Group B)|"Wellth app~Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program."
11354362|NCT03851094|EG000|Reported Event|Group A|"Control group~Standard of care procedures for new CPAP patients were followed."
11354363|NCT03851094|EG001|Reported Event|Group B|"Wellth app~Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program."
11354364|NCT03869450|BG000|Baseline|Restylane Volyme|"According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.~Restylane Volyme: Hyaluronic based filler"
11354365|NCT03869450|BG001|Baseline|Restylane Defyne|"According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.~Restylane Defyne: Hyaluronic based filler"
11168308|NCT01985971|EG000|Reported Event|EF5 PET/CT Imaging|PET/CT Imaging
11354366|NCT03869450|BG002|Baseline|Restylane Lyft Lidocaine|"According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.~Restylane Lyft Lidocaine: Hyaluronic based filler"
11354367|NCT03869450|BG003|Baseline|Total|Total of all reporting groups
11354368|NCT03869450|FG000|Participant Flow|Restylane Volyme|"According to the treatment algorithm, treated with Restylane Volyme~Restylane Volyme: Hyaluronic based filler"
11354369|NCT03869450|FG001|Participant Flow|Restylane Defyne|"According to the treatment algorithm, treated with Restylane Defyne~Restylane Defyne: Hyaluronic based filler"
11354370|NCT03869450|FG002|Participant Flow|Restylane Lyft Lidocaine|"According to the treatment algorithm, treated with Restylane Lyft Lidocaine~Restylane Lyft Lidocaine: Hyaluronic based filler"
11354371|NCT03869450|OG000|Outcome|Restylane Volyme|"According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.~Restylane Volyme: Hyaluronic based filler"
11354372|NCT03869450|OG001|Outcome|Restylane Defyne|"According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.~Restylane Defyne: Hyaluronic based filler"
11354373|NCT03869450|OG002|Outcome|Restylane Lyft Lidocaine|"According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.~Restylane Lyft Lidocaine: Hyaluronic based filler"
11354374|NCT03869450|EG000|Reported Event|Restylane Volyme|"According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.~Restylane Volyme: Hyaluronic based filler"
11354375|NCT03869450|EG001|Reported Event|Restylane Defyne|"According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.~Restylane Defyne: Hyaluronic based filler"
11231975|NCT02415842|OG000|Outcome|H5N1_VT|Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
11231976|NCT02415842|OG001|Outcome|H5N1_IN|Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration (3.8 µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration (3.8 µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12
11231977|NCT02415842|OG000|Outcome|DQIV_NAS|Subjects 18-≤39 years of age (in D-QIV cohort of primary completed study FLU D-QIV-015 (201251) (A/Christchurch/16/2010 (H1N1)pdm09, A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012, B/Brisbane/60/2008)) who were administered 15 µg HA (no AS) of each of 4 strains (total 60 µg HA) at Day 0.
11231978|NCT02415842|OG001|Outcome|H5N1_AS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
11231979|NCT02415842|OG002|Outcome|H9N2_AS|Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
11231980|NCT02415842|OG000|Outcome|H5N1_PAS|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03B) pandemic vaccine with 1.9 µg HA (hemagglutinin) at Days 0 and 21.
11231981|NCT02415842|OG000|Outcome|DQIV_NAS|Subjects 18-≤39 years of age (in D-QIVcohort of primary completed study FLU D-QIV-015 (201251) (A/Christchurch/16/2010 (H1N1)pdm09, A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012, B/Brisbane/60/2008)) who were administered 15 µg HA (no AS) of each of 4 strains (total 60 µg HA) at Day 0.
11231982|NCT02415842|OG000|Outcome|H5N1_AS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
11231983|NCT02415842|OG001|Outcome|H5N1_NAS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21
11231984|NCT02415842|OG000|Outcome|H9N2_AS|Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
11231985|NCT02415842|OG001|Outcome|H9N2_NAS|Subjects 18-64 years of age (in H9N2 cohort of primary completed studyQ-PAN H9N2-001 (116358)(A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and with saline placebo at Day 182.
11231986|NCT02415842|OG001|Outcome|QPAN5_C|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
11231987|NCT02415842|OG002|Outcome|QPAN5_G|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
11231988|NCT02415842|OG003|Outcome|H5N1_VT|Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
11231989|NCT02415842|OG004|Outcome|H5N1_IN|Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration (3.8 µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration (3.8 µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12
11231990|NCT02415842|OG006|Outcome|QPAN5_C|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
11231991|NCT02415842|OG007|Outcome|QPAN5_G|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
11231992|NCT02415842|OG008|Outcome|H5N1_VT|Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
11231993|NCT02415842|OG009|Outcome|H5N1_IN|Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration (3.8 µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration (3.8 µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12
11231994|NCT02415842|EG000|Reported Event|H1N1_AS|Subjects 19-40 years of age (in H1N1 cohort of primary completed study Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
11231995|NCT02415842|EG001|Reported Event|H1N1_NAS|Subjects 19-40 years of age (in H1N1 cohort of primary completed study -Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
11231996|NCT02415842|EG002|Reported Event|H5N1_AS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
11231997|NCT02415842|EG003|Reported Event|H5N1_NAS|Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21
11231998|NCT02415842|EG004|Reported Event|H9N2_AS|Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
11231999|NCT02415842|EG005|Reported Event|H9N2_NAS|Subjects 18-64 years of age (in H9N2 cohort of primary completed studyQ-PAN H9N2-001 (116358)(A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and with saline placebo at Day 182.
11232000|NCT02415842|EG006|Reported Event|DQIV_NAS|Subjects 18-≤39 years of age (in D-QIV cohort of primary completed study FLU D-QIV-015 (201251) (A/Christchurch/16/2010 (H1N1)pdm09, A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012, B/Brisbane/60/2008)) who were administered 15 µg HA (no AS) of each of 4 strains (total 60 µg HA) at Day 0.
11232001|NCT02415842|EG007|Reported Event|QPAN5_C|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
11232002|NCT02415842|EG008|Reported Event|QPAN5_G|Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
11232003|NCT02415842|EG009|Reported Event|H5N1_VT|Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
11232004|NCT02415842|EG010|Reported Event|H5N1_IN|Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration (3.8 µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration (3.8 µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12
11232005|NCT02415842|EG011|Reported Event|H5N1_PAS|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03B) pandemic vaccine with 1.9 µg HA (hemagglutinin) at Days 0 and 21.
11232006|NCT02415842|EG012|Reported Event|H5N1_PCN|Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered placebo at Days 0 and 21.
11232007|NCT02415855|BG000|Baseline|Dabigatran 110 mg BID|Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.
11232008|NCT02415855|BG001|Baseline|Dabigatran 150mg BID|Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
11232009|NCT02415855|BG002|Baseline|Total|Total of all reporting groups
11232010|NCT02415855|FG000|Participant Flow|Dabigatran 110 mg BID|Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.
11232011|NCT02415855|FG001|Participant Flow|Dabigatran 150mg BID|Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
11232012|NCT02415855|OG000|Outcome|Dabigatran 110 mg BID|Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.
11232013|NCT02415855|OG001|Outcome|Dabigatran 150mg BID|Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
11232014|NCT02415855|EG000|Reported Event|Dabigatran 110 mg BID|Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.
11232015|NCT02415855|EG001|Reported Event|Dabigatran 150mg BID|Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
11232016|NCT02415959|BG000|Baseline|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
11232017|NCT02415959|BG001|Baseline|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
11232018|NCT02415959|BG002|Baseline|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
11232019|NCT02415959|BG003|Baseline|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
11232020|NCT02415959|BG004|Baseline|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
11232021|NCT02415959|BG005|Baseline|Total|Total of all reporting groups
11232022|NCT02415959|FG000|Participant Flow|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
11232023|NCT02415959|FG001|Participant Flow|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
11232024|NCT02415959|FG002|Participant Flow|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
11232025|NCT02415959|FG003|Participant Flow|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
11232026|NCT02415959|FG004|Participant Flow|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
11232027|NCT02415959|OG000|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
11232028|NCT02415959|OG001|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
11232029|NCT02415959|OG002|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
11232030|NCT02415959|OG003|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
11232031|NCT02415959|OG004|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
11232032|NCT02415959|EG000|Reported Event|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
11232033|NCT02415959|EG001|Reported Event|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
11232034|NCT02415959|EG002|Reported Event|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
11232035|NCT02415959|EG003|Reported Event|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
11232036|NCT02415959|EG004|Reported Event|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
11232037|NCT02415998|BG000|Baseline|TEE Guided Epidural Cather Placement|TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
11232038|NCT02415998|FG000|Participant Flow|TEE Guided Epidural Catheter Placement|TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
11232039|NCT02415998|OG000|Outcome|TEE Guided Epidural Catheter Placement|TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
11232040|NCT02415998|EG000|Reported Event|TEE Guided Epidural Cather Placement|TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
11232041|NCT02416102|BG000|Baseline|Healthy Non-smokers|"10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232042|NCT02416102|BG001|Baseline|Smokers Without COPD|"10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232043|NCT02416102|BG002|Baseline|Ex-smokers With COPD|"10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232044|NCT02416102|BG003|Baseline|Total|Total of all reporting groups
11232045|NCT02416102|FG000|Participant Flow|Healthy Non-smokers|"10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg once daily (QD) for 4 weeks~losartan 100 mg: 50 mg twice daily (BID) for 4 weeks"
11232046|NCT02416102|FG001|Participant Flow|Smokers Without COPD|"10 smokers without Chronic Obstructive Pulmonary Disease (COPD) will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232047|NCT02416102|FG002|Participant Flow|Ex-smokers With COPD|"10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232048|NCT02416102|OG000|Outcome|Healthy Non-smokers|"10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232049|NCT02416102|OG001|Outcome|Smokers Without COPD|"10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232050|NCT02416102|OG002|Outcome|Ex-smokers With COPD|"10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232051|NCT02416102|EG000|Reported Event|Healthy Non-smokers|"10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232052|NCT02416102|EG001|Reported Event|Smokers Without COPD|"10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232053|NCT02416102|EG002|Reported Event|Ex-smokers With COPD|"10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks~Losartan 50 mg: 50 mg QD for 4 weeks~losartan 100 mg: 50 mg BID for 4 weeks"
11232054|NCT02416180|BG000|Baseline|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
11232055|NCT02416180|FG000|Participant Flow|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via metered dose inhaler (MDI) for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI Patient Information Leaflet (PIL) and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
11232056|NCT02416180|OG000|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
11232057|NCT02416180|EG000|Reported Event|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
11232058|NCT02416193|BG000|Baseline|Low Dose|5,000 IU cholecalciferol once weekly for three months
11232059|NCT02416193|BG001|Baseline|High Dose|50,000 IU cholecalciferol once weekly for three months
11232060|NCT02416193|BG002|Baseline|Total|Total of all reporting groups
11232061|NCT02416193|FG000|Participant Flow|Low Dose|5,000 IU cholecalciferol once weekly for three months
11232062|NCT02416193|FG001|Participant Flow|High Dose|50,000 IU cholecalciferol once weekly for three months
11232063|NCT02416193|OG000|Outcome|Low Dose|5,000 IU cholecalciferol once weekly for three months
11232064|NCT02416193|OG001|Outcome|High Dose|50,000 IU cholecalciferol once weekly for three months
11232065|NCT02416193|EG000|Reported Event|Low Dose|5,000 IU cholecalciferol once weekly for three months
11232066|NCT02416193|EG001|Reported Event|High Dose|50,000 IU cholecalciferol once weekly for three months
11232067|NCT02416453|BG000|Baseline|Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
11232068|NCT02416453|BG001|Baseline|Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232069|NCT02416453|BG002|Baseline|Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232070|NCT02416453|BG003|Baseline|Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
11232071|NCT02416453|BG004|Baseline|Group 1: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 29.
11232072|NCT02416453|BG005|Baseline|Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232073|NCT02416453|BG006|Baseline|Group 2: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 57.
11232074|NCT02416453|BG007|Baseline|Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232075|NCT02416453|BG008|Baseline|Group 3: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 85.
11232076|NCT02416453|BG009|Baseline|Group 4: Ad26.ZEBOV|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
11232077|NCT02416453|BG010|Baseline|Group 4: Placebo|Participants received IM injection of placebo Day 1.
11232078|NCT02416453|BG011|Baseline|Total|Total of all reporting groups
11232079|NCT02416453|FG000|Participant Flow|Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
11232080|NCT02416453|FG001|Participant Flow|Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232081|NCT02416453|FG002|Participant Flow|Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232082|NCT02416453|FG003|Participant Flow|Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
11232083|NCT02416453|FG004|Participant Flow|Group 1: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 29.
11232084|NCT02416453|FG005|Participant Flow|Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232085|NCT02416453|FG006|Participant Flow|Group 2: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 57.
11232086|NCT02416453|FG007|Participant Flow|Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232087|NCT02416453|FG008|Participant Flow|Group 3: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 85.
11232088|NCT02416453|FG009|Participant Flow|Group 4: Ad26.ZEBOV|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
11232089|NCT02416453|FG010|Participant Flow|Group 4: Placebo|Participants received IM injection of placebo Day 1.
11232090|NCT02416453|OG000|Outcome|Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
11232091|NCT02416453|OG001|Outcome|Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232092|NCT02416453|OG002|Outcome|Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232093|NCT02416453|OG003|Outcome|Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
11232094|NCT02416453|OG004|Outcome|Group 1: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 29.
11232095|NCT02416453|OG005|Outcome|Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232096|NCT02416453|OG006|Outcome|Group 2: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 57.
11232097|NCT02416453|OG007|Outcome|Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232098|NCT02416453|OG008|Outcome|Group 3: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 85.
11232099|NCT02416453|OG000|Outcome|Group 4: Ad26.ZEBOV|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
11232100|NCT02416453|OG001|Outcome|Group 4: Placebo|Participants received IM injection of placebo Day 1.
11232101|NCT02416453|OG000|Outcome|Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
11232102|NCT02416453|OG001|Outcome|Group 1: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 29.
11232103|NCT02416453|OG002|Outcome|Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232104|NCT02416453|OG003|Outcome|Group 2: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 57.
11232105|NCT02416453|OG004|Outcome|Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232106|NCT02416453|OG005|Outcome|Group 3: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 85.
11232107|NCT02416453|EG000|Reported Event|Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
11232108|NCT02416453|EG001|Reported Event|Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232109|NCT02416453|EG002|Reported Event|Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232110|NCT02416453|EG003|Reported Event|Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
11232111|NCT02416453|EG004|Reported Event|Group 1: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 29.
11232112|NCT02416453|EG005|Reported Event|Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
11232113|NCT02416453|EG006|Reported Event|Group 2: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 57.
11232114|NCT02416453|EG007|Reported Event|Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
11232115|NCT02416453|EG008|Reported Event|Group 3: Pooled Cohorts II and III: Placebo|Participants received IM injection of placebo on Day 1 and Day 85.
11232116|NCT02416453|EG009|Reported Event|Group 4: Ad26.ZEBOV|Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
11232117|NCT02416453|EG010|Reported Event|Group 4: Placebo|Participants received IM injection of placebo Day 1.
11232118|NCT02416622|BG000|Baseline|rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye|Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232119|NCT02416622|BG001|Baseline|rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye|Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232120|NCT02416622|BG002|Baseline|rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye|Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232121|NCT02416622|BG003|Baseline|Total|Total of all reporting groups
11232122|NCT02416622|FG000|Participant Flow|rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye|Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232123|NCT02416622|FG001|Participant Flow|rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye|Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232124|NCT02416622|FG002|Participant Flow|rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye|Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232125|NCT02416622|OG000|Outcome|rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye|Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232126|NCT02416622|OG001|Outcome|rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye|Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232127|NCT02416622|OG002|Outcome|rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye|Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232128|NCT02416622|EG000|Reported Event|rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye|Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232129|NCT02416622|EG001|Reported Event|rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye|Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232130|NCT02416622|EG002|Reported Event|rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye|Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10^11 vg/eye and followed for a minimum of 12 months after dose administration.
11232131|NCT02416713|BG000|Baseline|Education Only (Control)|"The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving.~Education Only: No active intervention, educational materials will be provided"
11232132|NCT02416713|BG001|Baseline|Opt-in Blocking|"Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232133|NCT02416713|BG002|Baseline|Opt-out Blocking|"Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232134|NCT02416713|BG003|Baseline|Opt-out Blocking With Notification|"Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232135|NCT02416713|BG004|Baseline|Total|Total of all reporting groups
11232136|NCT02416713|FG000|Participant Flow|Education Only (Control)|"The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving.~Education Only: No active intervention, educational materials will be provided"
11232137|NCT02416713|FG001|Participant Flow|Opt-in Blocking|"Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232138|NCT02416713|FG002|Participant Flow|Opt-out Blocking|"Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232139|NCT02416713|FG003|Participant Flow|Opt-out Blocking With Notification|"Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232140|NCT02416713|OG000|Outcome|Education Only (Control)|"The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving.~Education Only: No active intervention, educational materials will be provided"
11232141|NCT02416713|OG001|Outcome|Opt-in Blocking|"Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232142|NCT02416713|OG002|Outcome|Opt-out Blocking|"Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232143|NCT02416713|OG003|Outcome|Opt-out Blocking With Notification|"Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232144|NCT02416713|EG000|Reported Event|Education Only (Control)|"The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving.~Education Only: No active intervention, educational materials will be provided"
11232145|NCT02416713|EG001|Reported Event|Opt-in Blocking|"Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232146|NCT02416713|EG002|Reported Event|Opt-out Blocking|"Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232147|NCT02416713|EG003|Reported Event|Opt-out Blocking With Notification|"Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian.~Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts."
11232148|NCT02416791|BG000|Baseline|Active tDCS + Robotic Therapy + Physical Therapy|"Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.~Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.~Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).~Physical Therapy: Physical therapy will be administered for 40 minutes."
11232149|NCT02416791|BG001|Baseline|Sham tDCS + Robotic Therapy + Physical Therapy|"Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.~Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.~Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.~Physical Therapy: Physical therapy will be administered for 40 minutes."
11232150|NCT02416791|BG002|Baseline|Sham tDCS + Physical Therapy + Occupational Therapy|"Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.~Physical Therapy: Physical therapy will be administered for 40 minutes.~Occupational Therapy: Occupational therapy will be administered for 40 minutes."
11232151|NCT02416791|BG003|Baseline|Total|Total of all reporting groups
11232152|NCT02416791|FG000|Participant Flow|Active tDCS + Robotic Therapy + Physical Therapy|"Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.~Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.~Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).~Physical Therapy: Physical therapy will be administered for 40 minutes."
11232153|NCT02416791|FG001|Participant Flow|Sham tDCS + Robotic Therapy + Physical Therapy|"Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.~Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.~Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.~Physical Therapy: Physical therapy will be administered for 40 minutes."
11232154|NCT02416791|FG002|Participant Flow|Sham tDCS + Physical Therapy + Occupational Therapy|"Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.~Physical Therapy: Physical therapy will be administered for 40 minutes.~Occupational Therapy: Occupational therapy will be administered for 40 minutes."
11357292|NCT03760913|BG002|Baseline|120 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng
11232155|NCT02416791|OG000|Outcome|Active tDCS + Robotic Therapy + Physical Therapy|"Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.~Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.~Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).~Physical Therapy: Physical therapy will be administered for 40 minutes."
11232156|NCT02416791|OG001|Outcome|Sham tDCS + Robotic Therapy + Physical Therapy|"Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.~Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.~Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.~Physical Therapy: Physical therapy will be administered for 40 minutes."
11232157|NCT02416791|OG002|Outcome|Sham tDCS + Physical Therapy + Occupational Therapy|"Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.~Physical Therapy: Physical therapy will be administered for 40 minutes.~Occupational Therapy: Occupational therapy will be administered for 40 minutes."
11232158|NCT02416791|EG000|Reported Event|Active tDCS + Robotic Therapy + Physical Therapy|"Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.~Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.~Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).~Physical Therapy: Physical therapy will be administered for 40 minutes."
11232159|NCT02416791|EG001|Reported Event|Sham tDCS + Robotic Therapy + Physical Therapy|"Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.~Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.~Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.~Physical Therapy: Physical therapy will be administered for 40 minutes."
11232160|NCT02416791|EG002|Reported Event|Sham tDCS + Physical Therapy + Occupational Therapy|"Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).~Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.~Physical Therapy: Physical therapy will be administered for 40 minutes.~Occupational Therapy: Occupational therapy will be administered for 40 minutes."
11232161|NCT02416908|BG000|Baseline|Phase I Schedule A (Selinexor)|"Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232162|NCT02416908|BG001|Baseline|Phase I Schedule B (Selinexor)|"Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232163|NCT02416908|BG002|Baseline|Phase II (Selinexor)|"Selinexor will be given at the schedule as determined in Phase 1.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232164|NCT02416908|BG003|Baseline|Total|Total of all reporting groups
11232165|NCT02416908|FG000|Participant Flow|Phase I Schedule A (Selinexor)|"Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232166|NCT02416908|FG001|Participant Flow|Phase I Schedule B (Selinexor)|"Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232167|NCT02416908|FG002|Participant Flow|Phase II (Selinexor)|"Selinexor will be given at the schedule as determined in Phase 1.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232168|NCT02416908|FG003|Participant Flow|Selinexor Maintenance Phase (Optional)|"These patients were enrolled and treated in the Phase I Schedule A Arm or the Phase II Arm and if they met the requirements below then they were able to receive maintenance selinexor~Available for patients who have achieved a CR or CRi based on post-treatment bone marrow assessment at the time of hematopoietic recovery and are either (1) transplant ineligible or (2) do not have a stem cell transplant donor available~60 mg selinexor on Days 1, 8, 15, and 22 of a 28-day cycle"
11232169|NCT02416908|OG000|Outcome|Phase I Schedule A and Phase II|"Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232170|NCT02416908|EG000|Reported Event|Phase I Schedule A (Selinexor)|"Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232171|NCT02416908|EG001|Reported Event|Phase I Schedule B (Selinexor)|"Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232172|NCT02416908|EG002|Reported Event|Phase II (Selinexor)|"Selinexor will be given at the schedule as determined in Phase 1.~Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).~Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.~G-CSF will be given 300 mcg SC once daily on Days 3-8.~Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.~Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response."
11232173|NCT02416908|EG003|Reported Event|Selinexor Maintenance Phase (Optional)|"Available for patients who have achieved a CR or CRi based on post-treatment bone marrow assessment at the time of hematopoietic recovery and are either (1) transplant ineligible or (2) do not have a stem cell transplant donor available~60 mg selinexor on Days 1, 8, 15, and 22 of a 28-day cycle"
11232174|NCT02416934|BG000|Baseline|Treatment 1; Dexamethasone|"Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.~Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
11232175|NCT02416934|BG001|Baseline|Treatment 0; Saline Placebo|"Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.~Treatment 0; Saline placebo: Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
11232176|NCT02416934|BG002|Baseline|Total|Total of all reporting groups
11232177|NCT02416934|FG000|Participant Flow|Treatment 1; Dexamethasone|Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 1; Dexamethasone
11232178|NCT02416934|FG001|Participant Flow|Treatment 0; Saline Placebo|Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 0; Saline placebo
11232179|NCT02416934|OG000|Outcome|Dexamethasone DSQ|"Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone.~Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
11335569|NCT03552757|BG001|Baseline|Semaglutide 2.4 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11335570|NCT03552757|BG002|Baseline|Placebo|Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11232180|NCT02416934|OG001|Outcome|Saline Placebo DSQ|"Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline.~Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
11232181|NCT02416934|OG002|Outcome|Dexamethasone Bazaz|"Treatment 1; Dexamethasone. Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone.~Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
11232182|NCT02416934|OG003|Outcome|Saline Placebo Bazaz|"Treatment 0; Saline Placebo. Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline.~Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
11232183|NCT02416934|OG000|Outcome|Change in Quality of Life Dexamethasone|Change in quality of life from baseline to 1 year (or last visit as appropriate). Not all subjects came for 1 year follow up.
11232184|NCT02416934|OG001|Outcome|Change in Quality of Life Saline Placebo|Change in quality of life from baseline to 1 year (or last visit as appropriate.) Not all subjects came for 1 year follow up.
11232185|NCT02416934|OG000|Outcome|Dexamethasone Fusion|Fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.
11232186|NCT02416934|OG001|Outcome|Saline Fusion|Fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.
11232187|NCT02416934|EG000|Reported Event|Treatment 1; Dexamethasone|Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.
11232188|NCT02416934|EG001|Reported Event|Treatment 0; Saline Placebo|Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.
11232189|NCT02416973|BG000|Baseline|Sham of Provant|"Sham of Provant~Provant"
11232190|NCT02416973|BG001|Baseline|Active Treatment|"Active Provant Treatment~Provant"
11232191|NCT02416973|BG002|Baseline|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
11232192|NCT02416973|BG003|Baseline|Total|Total of all reporting groups
11232193|NCT02416973|FG000|Participant Flow|Sham of Provant|"Sham of Provant~Provant"
11232194|NCT02416973|FG001|Participant Flow|Active Treatment|"Active Provant Treatment~Provant"
11232195|NCT02416973|FG002|Participant Flow|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
11232196|NCT02416973|OG000|Outcome|Sham of Provant|"Sham of Provant~Provant"
11232197|NCT02416973|OG001|Outcome|Active Treatment|"Active Provant Treatment~Provant"
11232198|NCT02416973|OG002|Outcome|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
11232199|NCT02416973|EG000|Reported Event|Sham of Provant|"Sham of Provant~Provant"
11232200|NCT02416973|EG001|Reported Event|Active Treatment|"Active Provant Treatment~Provant"
11232201|NCT02416973|EG002|Reported Event|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
11335571|NCT03552757|BG003|Baseline|Total|Total of all reporting groups
11354376|NCT03869450|EG002|Reported Event|Restylane Lyft Lidocaine|"According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.~Restylane Lyft Lidocaine: Hyaluronic based filler"
11354377|NCT03868631|BG000|Baseline|Soy Protein Group|Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
11354378|NCT03868631|BG001|Baseline|Whey Protein Group|Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
11354379|NCT03868631|BG002|Baseline|Total|Total of all reporting groups
11354380|NCT03868631|FG000|Participant Flow|Soy Protein Group|Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
11354381|NCT03868631|FG001|Participant Flow|Whey Protein Group|Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
11354382|NCT03868631|OG000|Outcome|Soy Protein Group|Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
11354383|NCT03868631|OG001|Outcome|Whey Protein Group|Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
11354384|NCT03868631|EG000|Reported Event|Soy Protein Group|Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
11354385|NCT03868631|EG001|Reported Event|Whey Protein Group|Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
11354386|NCT03865953|BG000|Baseline|LAT8881, Then Placebo|In the first intervention period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, a placebo capsule was taken twice daily (morning and evening) for four weeks.
11354387|NCT03865953|BG001|Baseline|Placebo, Then LAT8881|In the first intervention period, a placebo capsule was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks.
11354388|NCT03865953|BG002|Baseline|Total|Total of all reporting groups
11354389|NCT03865953|FG000|Participant Flow|LAT8881, Then Placebo|In the first intervention period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, a placebo capsule was taken twice daily (morning and evening) for four weeks.
11354390|NCT03865953|FG001|Participant Flow|Placebo, Then LAT8881|In the first intervention period, a placebo capsule was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks.
11354391|NCT03865953|OG000|Outcome|LAT8881|"1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period.~LAT8881: LAT8881 oral capsule"
11354392|NCT03865953|OG001|Outcome|Placebo|"1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period.~Placebo: Placebo oral capsule"
11168309|NCT01986010|BG000|Baseline|HCMV Seropositive (+) V160 10u Intramuscular (IM)|Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11354393|NCT03865953|EG000|Reported Event|LAT8881|"1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period.~LAT8881: LAT8881 oral capsule"
11354394|NCT03865953|EG001|Reported Event|Placebo|"1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period.~Placebo: Placebo oral capsule"
11354395|NCT03865381|BG000|Baseline|Virtual Diabetes Clinic|The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician.
11354396|NCT03865381|FG000|Participant Flow|Virtual Diabetes Clinic|The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician.
11354397|NCT03865381|OG000|Outcome|Virtual Diabetes Clinic|The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician.
11354398|NCT03865381|EG000|Reported Event|Virtual Diabetes Clinic|The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician.
11354399|NCT03865446|BG000|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of dacomitinib 30 mg tablet on Day 1 and were followed up to a maximum of 35 days for safety.
11354400|NCT03865446|BG001|Baseline|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of dacomitinib 30 mg tablet on Day 1 and were followed up to a maximum of 35 days for safety.
11354401|NCT03865446|BG002|Baseline|Total|Total of all reporting groups
11354402|NCT03865446|FG000|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of dacomitinib 30 milligram (mg) tablet on Day 1 and were followed up to a maximum of 35 days for safety.
11354403|NCT03865446|FG001|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of dacomitinib 30 mg tablet on Day 1 and were followed up to a maximum of 35 days for safety.
11232202|NCT02417064|BG000|Baseline|Intranasal Esketamine 56 mg Plus Oral Antidepressant|Participants self-administered 56 milligram (mg) of intranasal esketamine (Esk) twice per week for 4 weeks in double-blind (DB) induction phase. Also, participants simultaneously initiated new oral antidepressant (AD) with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine extended release (XR) (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003 [NCT02493868]) and had received at least 1 dose of intranasal Esk 56 mg+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232203|NCT02417064|BG001|Baseline|Intranasal Esketamine 84 mg Plus Oral AD|Participants self-administered 56 mg of intranasal esketamine on Day 1 and then 84 mg from Day 4 onwards twice per week for 4 Weeks in DB induction phase. Also, participants simultaneously initiated new oral AD with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal Esk 84 mg+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232204|NCT02417064|BG002|Baseline|Oral AD Plus Intranasal Placebo|Participants self-administered intranasal matching placebo, twice per week for 4 weeks in DB induction phase. Also, participants simultaneously initiated new oral AD with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal placebo+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232205|NCT02417064|BG003|Baseline|Total|Total of all reporting groups
11232206|NCT02417064|FG000|Participant Flow|Intranasal Esketamine 56 mg Plus Oral Antidepressant|Participants self-administered 56 milligram (mg) of intranasal esketamine (Esk) twice per week for 4 weeks in double-blind (DB) induction phase. Also, participants simultaneously initiated new oral antidepressant (AD) with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine extended release (XR) (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003 [NCT02493868]) and had received at least 1 dose of intranasal Esk 56 mg+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232207|NCT02417064|FG001|Participant Flow|Intranasal Esketamine 84 mg Plus Oral AD|Participants self-administered 56 mg of intranasal esketamine on Day 1 and then 84 mg from Day 4 onwards twice per week for 4 Weeks in DB induction phase. Also, participants simultaneously initiated new oral AD with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal Esk 84 mg+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232208|NCT02417064|FG002|Participant Flow|Oral AD Plus Intranasal Placebo|Participants self-administered intranasal matching placebo, twice per week for 4 weeks in DB induction phase. Also, participants simultaneously initiated new oral AD with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal placebo+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11335572|NCT03552757|FG000|Participant Flow|Semaglutide 1.0 mg|Participants received once-weekly subcutaneous (s.c; under the skin) semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11354404|NCT03865446|OG000|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of dacomitinib 30 mg tablet on Day 1 and were followed up to a maximum of 35 days for safety.
11168310|NCT01986010|BG001|Baseline|HCMV + V160 30u IM|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168311|NCT01986010|BG002|Baseline|HCMV+ V160 100u IM|Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168312|NCT01986010|BG003|Baseline|HCMV+ V160 100u MAPA IM|Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168313|NCT01986010|BG004|Baseline|HCMV+ V160 250u IM|Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168314|NCT01986010|BG005|Baseline|HCMV+ Placebo IM|Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
11168315|NCT01986010|BG006|Baseline|HCMV+ V160 30u ID|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
11168316|NCT01986010|BG007|Baseline|HCMV+ Placebo ID|Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
11168317|NCT01986010|BG008|Baseline|HCMV Seronegative (-) V160 10u IM|Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168318|NCT01986010|BG009|Baseline|HCMV- V160 30u IM|Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
11168319|NCT01986010|BG010|Baseline|HCMV- V160 30u MAPA IM|Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168320|NCT01986010|BG011|Baseline|HCMV- V160 100u IM|Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
11168321|NCT01986010|BG012|Baseline|HCMV- V160 100u MAPA IM|Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
11168322|NCT01986010|BG013|Baseline|HCMV- V160 250u IM|Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168323|NCT01986010|BG014|Baseline|HCMV- V160 Placebo IM|Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
11168324|NCT01986010|BG015|Baseline|HCMV- V160 30u ID|Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
11168325|NCT01986010|BG016|Baseline|HCMV- Placebo ID|Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
11168326|NCT01986010|BG017|Baseline|Total|Total of all reporting groups
11168327|NCT01986010|FG000|Participant Flow|HCMV Seropositive (+) V160 10u Intramuscular (IM)|Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10 units (u) V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168328|NCT01986010|FG001|Participant Flow|HCMV + V160 30u IM|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168329|NCT01986010|FG002|Participant Flow|HCMV+ V160 100u IM|Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168330|NCT01986010|FG003|Participant Flow|HCMV+ V160 100u MAPA IM|Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168331|NCT01986010|FG004|Participant Flow|HCMV+ V160 250u IM|Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168332|NCT01986010|FG005|Participant Flow|HCMV+ Placebo IM|Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
11168333|NCT01986010|FG006|Participant Flow|HCMV+ V160 30u ID|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
11168334|NCT01986010|FG007|Participant Flow|HCMV+ Placebo ID|Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
11168335|NCT01986010|FG008|Participant Flow|HCMV Seronegative (-) V160 10u IM|Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168336|NCT01986010|FG009|Participant Flow|HCMV- V160 30u IM|Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
11168337|NCT01986010|FG010|Participant Flow|HCMV- V160 30u MAPA IM|Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168338|NCT01986010|FG011|Participant Flow|HCMV- V160 100u IM|Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
11168339|NCT01986010|FG012|Participant Flow|HCMV- V160 100u MAPA IM|Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
11168340|NCT01986010|FG013|Participant Flow|HCMV- V160 250u IM|Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168341|NCT01986010|FG014|Participant Flow|HCMV- V160 Placebo IM|Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
11168342|NCT01986010|FG015|Participant Flow|HCMV- V160 30u ID|Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
11168343|NCT01986010|FG016|Participant Flow|HCMV- Placebo ID|Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
11168344|NCT01986010|OG000|Outcome|HCMV Seropositive (+) V160 10u Intramuscular (IM)|Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11354405|NCT03865446|OG001|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of dacomitinib 30 mg tablet on Day 1 and were followed up to a maximum of 35 days for safety.
11354406|NCT03865446|EG000|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of dacomitinib 30 mg tablet on Day 1 and were followed up to a maximum of 35 days for safety.
11354407|NCT03865446|EG001|Reported Event|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of dacomitinib 30 mg tablet on Day 1 and were followed up to a maximum of 35 days for safety.
11354408|NCT03862027|BG000|Baseline|Esophageal Balloon Catheter|"All patients will have an esophageal balloon catheter inserted into their nare while upright (head of bed > 30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20 cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.~Esophageal Balloon catheter: Pressures [Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP.~PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP).~Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP."
11354409|NCT03862027|FG000|Participant Flow|Esophageal Balloon Catheter|"All patients will have an esophageal balloon catheter inserted into their nare while upright (head of bed > 30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20 cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.~Esophageal Balloon catheter: Pressures [Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP.~PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP).~Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP."
11354410|NCT03862027|OG000|Outcome|Esophageal Balloon Catheter|"All patients will have an esophageal balloon catheter inserted into their nare while upright (head of bed > 30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20 cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.~Esophageal Balloon catheter: Pressures [Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP.~PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP).~Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP."
11354411|NCT03862027|EG000|Reported Event|Esophageal Balloon Catheter|"All patients will have an esophageal balloon catheter inserted into their nare while upright (head of bed > 30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20 cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.~Esophageal Balloon catheter: Pressures [Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP.~PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP).~Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP."
11354412|NCT03859960|BG000|Baseline|Motor Complete Group|Individuals with American Spinal Injury Association Impairment Scale (AIS) grades A and B.
11354413|NCT03859960|BG001|Baseline|Motor Incomplete Group|Individuals with American Spinal Injury Association Impairment Scale (AIS) grades C and D.
11354414|NCT03859960|BG002|Baseline|Total|Total of all reporting groups
11354415|NCT03859960|FG000|Participant Flow|Motor Complete Group|Individuals with American Spinal Injury Association (ASIA) Impairment Scale grades A and B.
11354416|NCT03859960|FG001|Participant Flow|Motor Incomplete Group|Individuals with American Spinal Injury Association (ASIA) Impairment Scale grades C and D.
11354417|NCT03859960|OG000|Outcome|Motor Complete|American Spinal Injury Association Impairment Scale (AIS) Grades of A, B
11354418|NCT03859960|OG001|Outcome|Motor Incomplete|American Spinal Injury Association Impairment Scale (AIS) Grades of C, D
11354419|NCT03859960|OG000|Outcome|Motor Complete Group|Individuals with American Spinal Injury Association Impairment Scale (AIS) grade A and B.
11354420|NCT03859960|OG001|Outcome|Motor Incomplete Group|Individuals with American Spinal Injury Association Impairment Scale (AIS) grades C and D.
11354421|NCT03859960|EG000|Reported Event|Motor Complete|individuals with AIS A, B
11354422|NCT03859960|EG001|Reported Event|Motor Incomplete|individuals with AIS C, D
11357293|NCT03760913|BG003|Baseline|400 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng
11168345|NCT01986010|OG001|Outcome|HCMV + V160 30u IM|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11232209|NCT02417064|OG000|Outcome|Intranasal Esketamine 56 mg Plus Oral Antidepressant|Participants self-administered 56 milligram (mg) of intranasal esketamine (Esk) twice per week for 4 weeks in double-blind (DB) induction phase. Also, participants simultaneously initiated new oral antidepressant (AD) with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine extended release (XR) (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003 [NCT02493868]) and had received at least 1 dose of intranasal Esk 56 mg+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232210|NCT02417064|OG001|Outcome|Intranasal Esketamine 84 mg Plus Oral AD|Participants self-administered 56 mg of intranasal esketamine on Day 1 and then 84 mg from Day 4 onwards twice per week for 4 Weeks in DB induction phase. Also, participants simultaneously initiated new oral AD with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal Esk 84 mg+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232211|NCT02417064|OG002|Outcome|Oral AD Plus Intranasal Placebo|Participants self-administered intranasal matching placebo, twice per week for 4 weeks in DB induction phase. Also, participants simultaneously initiated new oral AD with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase. Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal placebo+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232212|NCT02417064|EG000|Reported Event|DB Phase: Intranasal Esk 56 mg + Oral AD|Participants self-administered 56 mg of intranasal esketamine (Esk) twice per week for 4 weeks in double-blind (DB) induction phase. Also, participants simultaneously initiated new oral antidepressant (AD) with one of following: duloxetine (60 [milligram] mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase.
11232213|NCT02417064|EG001|Reported Event|DB Phase: Intranasal Esk 84 mg + Oral AD|Participants self-administered 56 mg of intranasal esketamine on Day 1 and then 84 mg from Day 4 onwards twice per week for 4 Weeks in DB induction phase. Also, participants simultaneously initiated new oral AD with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase.
11232214|NCT02417064|EG002|Reported Event|DB Phase: Oral AD + Intranasal Placebo|Participants self-administered intranasal matching placebo, intranasally, twice per week for 4 weeks in DB induction phase. Also, participants simultaneously initiated new oral AD with one of following: duloxetine (60 mg/day- Weeks 1, 2, 3 and 4), escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2 to 4 with minimum therapeutic dose [MTD] of 10 mg/day), sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MTD of 50 mg/day) or venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, 225 mg/day- Weeks 3 and 4 with MTD of 150 mg/day) on Day 1 taken daily in DB induction phase.
11232215|NCT02417064|EG003|Reported Event|FU Phase: Intranasal Esk 56 mg + Oral AD|Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal Esk 56 mg+ Oral AD in DB induction phase were followed in posttreatment follow-up (FU) phase for up to 24 weeks to assess safety and tolerability including withdrawal symptoms of study drug and for collection of additional informative data to assess the course of the participant's major depressive episode over a 24-week period.
11232216|NCT02417064|EG004|Reported Event|FU Phase: Intranasal Esk 84 mg + Oral AD|Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal Esk 84 mg+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks to assess safety and tolerability including withdrawal symptoms of study drug and for collection of additional informative data to assess the course of the participant's major depressive episode over a 24-week period.
11232217|NCT02417064|EG005|Reported Event|FU Phase: Oral AD + Intranasal Placebo|Participants who were not eligible or chose to not participate in maintenance of effect study (ESKETINTRD3003) and had received at least 1 dose of intranasal placebo+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks to assess safety and tolerability including withdrawal symptoms of study drug and for collection of additional informative data to assess the course of the participant's major depressive episode over a 24-week period.
11232218|NCT02417129|BG000|Baseline|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
11357294|NCT03760913|BG004|Baseline|1.2 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg
11168346|NCT01986010|OG002|Outcome|HCMV+ V160 100u IM|Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168347|NCT01986010|OG003|Outcome|HCMV+ V160 100u MAPA IM|Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168348|NCT01986010|OG004|Outcome|HCMV+ V160 250u IM|Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168349|NCT01986010|OG005|Outcome|HCMV+ Placebo IM|Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
11168350|NCT01986010|OG006|Outcome|HCMV+ V160 30u ID|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
11168351|NCT01986010|OG007|Outcome|HCMV+ Placebo ID|Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
11168352|NCT01986010|OG008|Outcome|HCMV Seronegative (-) V160 10u IM|Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168353|NCT01986010|OG009|Outcome|HCMV- V160 30u IM|Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
11168354|NCT01986010|OG010|Outcome|HCMV- V160 30u MAPA IM|Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168355|NCT01986010|OG011|Outcome|HCMV- V160 100u IM|Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
11168356|NCT01986010|OG012|Outcome|HCMV- V160 100u MAPA IM|Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
11168357|NCT01986010|OG013|Outcome|HCMV- V160 250u IM|Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168358|NCT01986010|OG014|Outcome|HCMV- V160 Placebo IM|Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
11168359|NCT01986010|OG015|Outcome|HCMV- V160 30u ID|Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
11168360|NCT01986010|OG016|Outcome|HCMV- Placebo ID|Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
11168361|NCT01986010|OG005|Outcome|HCMV+ V160 30u ID|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
11168362|NCT01986010|OG006|Outcome|HCMV+ Placebo IM or ID|Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6
11168363|NCT01986010|OG007|Outcome|HCMV Seronegative (-) V160 10u IM|Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168364|NCT01986010|OG008|Outcome|HCMV- V160 30u IM|Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
11168365|NCT01986010|OG009|Outcome|HCMV- V160 30u MAPA IM|Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168366|NCT01986010|OG010|Outcome|HCMV- V160 100u IM|Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
11168367|NCT01986010|OG011|Outcome|HCMV- V160 100u MAPA IM|Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
11168368|NCT01986010|OG012|Outcome|HCMV- V160 250u IM|Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168369|NCT01986010|OG013|Outcome|HCMV- V160 30u ID|Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
11168370|NCT01986010|OG014|Outcome|HCMV- Placebo IM or ID|Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
11168371|NCT01986010|EG000|Reported Event|HCMV + V160 10u IM|Participants seropositive for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168372|NCT01986010|EG001|Reported Event|HCMV + V160 30u IM|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168373|NCT01986010|EG002|Reported Event|HCMV + V160 100u IM|Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168374|NCT01986010|EG003|Reported Event|HCMV+ V160 100u MAPA IM|Participants seropositive for HCMV at Baseline received 100u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168375|NCT01986010|EG004|Reported Event|HCMV + V160 250u IM|Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168376|NCT01986010|EG005|Reported Event|HCMV+ Placebo IM|Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
11168377|NCT01986010|EG006|Reported Event|HCMV + V160 30u ID|Participants seropositive for HCMV at Baseline received 30u V160 vaccination by ID injection on Day 1, Month 1, and Month 6
11168378|NCT01986010|EG007|Reported Event|HCMV+ Placebo ID|Participants seropositive for HCMV at Baseline received placebo vaccination by ID injection on Day 1, Month 1, and Month 6
11168379|NCT01986010|EG008|Reported Event|HCMV- V160 10u IM|Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168380|NCT01986010|EG009|Reported Event|HCMV- V160 30u IM|Participants seronegative for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168381|NCT01986010|EG010|Reported Event|HCMV- V160 30u MAPA IM|Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11354423|NCT03868059|BG000|Baseline|LPCN 1021|"LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),~LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule."
11354424|NCT03868059|FG000|Participant Flow|LPCN 1021|"LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),~LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule."
11354425|NCT03868059|OG000|Outcome|LPCN 1021|"LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),~LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule."
11354426|NCT03868059|EG000|Reported Event|LPCN 1021|"LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),~LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule."
11354427|NCT03868254|BG000|Baseline|Implant|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
11354428|NCT03868254|BG001|Baseline|Implant + Phaco|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
11354429|NCT03868254|BG002|Baseline|Total|Total of all reporting groups
11168382|NCT01986010|EG011|Reported Event|HCMV- V160 100u IM|Participants seronegative for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11354430|NCT03868254|FG000|Participant Flow|Implant|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
11354431|NCT03868254|FG001|Participant Flow|Implant + Phaco|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
11354432|NCT03868254|OG000|Outcome|Implant|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
11354433|NCT03868254|OG001|Outcome|Implant + Phaco|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
11354434|NCT03868254|EG000|Reported Event|Implant|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
11354435|NCT03868254|EG001|Reported Event|Implant + Phaco|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
11354436|NCT03865407|BG000|Baseline|Allopurinol|"Allopurinol will be administered to this treatment arm group for 6 months. Participants will receive the lowest FDA recommended dose for weight, and will be titrated upwards to achieve the goal uric acid level of 3-5 mg/dL throughout the trial.~Allopurinol: Allopurinol dosed to target uric acid levels of 3-5 mg/dL."
11354437|NCT03865407|BG001|Baseline|Standard of Care Control|The treatment arm will be compared to a standard of care arm.
11354438|NCT03865407|BG002|Baseline|Total|Total of all reporting groups
11357295|NCT03760913|BG005|Baseline|3 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg
11168383|NCT01986010|EG012|Reported Event|HCMV- V160 100u MAPA IM|Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
11168384|NCT01986010|EG013|Reported Event|HCMV- V160 250u IM|Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
11168385|NCT01986010|EG014|Reported Event|HCMV- V160 Placebo IM|Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
11168386|NCT01986010|EG015|Reported Event|HCMV- V160 30u ID|Participants seronegative for HCMV at Baseline received 30u V160 vaccination by ID injection on Day 1, Month 1, and Month 6
11168387|NCT01986010|EG016|Reported Event|HCMV- V160 Placebo ID|Participants seronegative for HCMV at Baseline received placebo vaccination by ID injection on Day 1, Month 1, and Month 6
11168388|NCT01986062|BG000|Baseline|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID for one week (crossover to placebo administration week 2)
11168389|NCT01986062|BG001|Baseline|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID for one week (crossover to AR11 administration week 2)
11168390|NCT01986062|BG002|Baseline|Total|Total of all reporting groups
11168391|NCT01986062|FG000|Participant Flow|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
11168392|NCT01986062|FG001|Participant Flow|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
11168393|NCT01986062|OG000|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
11168394|NCT01986062|OG001|Outcome|Placebo|Placebo, administered orally, BID
11168395|NCT01986062|EG000|Reported Event|AR11|AR11, administered orally, BID for one week
11168396|NCT01986062|EG001|Reported Event|Placebo|Placebo, administered orally, BID for one week
11168397|NCT01986140|BG000|Baseline|Scalp Cooling|"Scalp Cooling~PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap"
11168398|NCT01986140|BG001|Baseline|Non-cooling|"Control~Control No treatment: No treatment to prevent hair loss"
11168399|NCT01986140|BG002|Baseline|Total|Total of all reporting groups
11168400|NCT01986140|FG000|Participant Flow|PAXMAN Orbis Scalp Cooler|"Scalp Cooling~PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap"
11168401|NCT01986140|FG001|Participant Flow|Control No Treatment|"Control~Control No treatment: No treatment to prevent hair loss"
11168402|NCT01986140|OG000|Outcome|Scalp Cooling|"Scalp Cooling~PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap"
11168403|NCT01986140|OG001|Outcome|Non-cooling|"Control~Control No treatment: No treatment to prevent hair loss"
11168404|NCT01986140|EG000|Reported Event|Scalp Cooling|"Scalp Cooling~PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap"
11168405|NCT01986140|EG001|Reported Event|Non-cooling|"Control~Control No Treatment: No treatment to prevent hair loss"
11168406|NCT01986231|BG000|Baseline|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
11168407|NCT01986231|FG000|Participant Flow|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
11168408|NCT01986231|OG000|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
11168409|NCT01986231|EG000|Reported Event|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
11168410|NCT01986348|BG000|Baseline|Arm A: Selinexor 60 mg and Surgery|Participants who required surgery received up to 3 doses of oral selinexor tablets 60 mg BIW on Day 1, Day 3 and between 2 and 48 hours prior to surgery, subsequently underwent surgery for resection of their tumor and resumed selinexor tablets 60 mg BIW after recovery, during Week 1 to 4 of each 4-week cycle, until PD or development of unacceptable toxicities.
11354439|NCT03865407|FG000|Participant Flow|Allopurinol|"Allopurinol will be administered to this treatment arm group for 6 months. Participants will receive the lowest FDA recommended dose for weight, and will be titrated upwards to achieve the goal uric acid level of 3-5 mg/dL throughout the trial.~Allopurinol: Allopurinol dosed to target uric acid levels of 3-5 mg/dL."
11354440|NCT03865407|FG001|Participant Flow|Standard of Care Control|The treatment arm will be compared to a standard of care arm.
11354441|NCT03865407|OG000|Outcome|Allopurinol|"Allopurinol will be administered to this treatment arm group for 6 months. Participants will receive the lowest FDA recommended dose for weight, and will be titrated upwards to achieve the goal uric acid level of 3-5 mg/dL throughout the trial.~Allopurinol: Allopurinol dosed to target uric acid levels of 3-5 mg/dL."
11354442|NCT03865407|OG001|Outcome|Standard of Care Control|The treatment arm will be compared to a standard of care arm.
11354443|NCT03865407|EG000|Reported Event|Allopurinol|"Allopurinol will be administered to this treatment arm group for 6 months. Participants will receive the lowest FDA recommended dose for weight, and will be titrated upwards to achieve the goal uric acid level of 3-5 mg/dL throughout the trial.~Allopurinol: Allopurinol dosed to target uric acid levels of 3-5 mg/dL."
11354444|NCT03865407|EG001|Reported Event|Standard of Care Control|The treatment arm will be compared to a standard of care arm.
11168411|NCT01986348|BG001|Baseline|Arm B: Selinexor 50 mg/m^2|Participants who were not eligible for surgery received selinexor tablets 50 mg/m^2 BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11354445|NCT03857230|BG000|Baseline|Sequence A: Primapur - Gonal-F|Subjects were randomly assigned to receive treatment sequence A: single subcutaneous injection of 300 IU Primapur on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Gonal-F.
11354446|NCT03857230|BG001|Baseline|Sequence B: Gonal-F - Primapur|Subjects were randomly assigned to receive treatment sequence B: single subcutaneous injection of 300 IU Gonal-F on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Primapur.
11354447|NCT03857230|BG002|Baseline|Total|Total of all reporting groups
11354448|NCT03857230|FG000|Participant Flow|Sequence A: Primapur - Gonal-F|Subjects were randomly assigned to receive treatment sequence A: single subcutaneous injection of 300 IU Primapur on study day 1, after 10 days of wash out period a single subcutaneous injection of 300 IU Gonal-F.
11354449|NCT03857230|FG001|Participant Flow|Sequence B: Gonal-F - Primapur|Subjects were randomly assigned to receive treatment sequence B: single subcutaneous injection of 300 IU Gonal-F on study day 1, after 10 days of wash out period a single subcutaneous injection of 300 IU Primapur.
11354450|NCT03857230|OG000|Outcome|Primapur|All subjects who received a single subcutaneous injection of 300 IU Primapur.
11354451|NCT03857230|OG001|Outcome|Gonal-F|All subjects who received a single subcutaneous injection of 300 IU Gonal-F.
11354452|NCT03857230|EG000|Reported Event|Primapur|All subjects who received a single subcutaneous injection of 300 IU Primapur.
11354453|NCT03857230|EG001|Reported Event|Gonal-F|All subjects who received a single subcutaneous injection of 300 IU Gonal-F.
11354454|NCT03865329|BG000|Baseline|Intervention- Home Pulmonary Rehabilitation|"Participants will be offered a Home-based pulmonary rehabilitation program with health coaching.~Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being)."
11354455|NCT03865329|FG000|Participant Flow|Intervention- Home Pulmonary Rehabilitation|"Participants will be offered a Home-based pulmonary rehabilitation program with health coaching.~Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being)."
11354456|NCT03865329|OG000|Outcome|Intervention- Home Pulmonary Rehabilitation|"Participants will be offered a Home-based pulmonary rehabilitation program with health coaching.~Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being)."
11357296|NCT03760913|BG006|Baseline|6 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg
11357297|NCT03760913|BG007|Baseline|12 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg
11232219|NCT02417129|FG000|Participant Flow|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
11232220|NCT02417129|FG001|Participant Flow|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
11232221|NCT02417129|OG000|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
11232222|NCT02417129|OG001|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
11232223|NCT02417129|EG000|Reported Event|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
11232224|NCT02417129|EG001|Reported Event|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
11232225|NCT02417233|BG000|Baseline|Standard of Care|Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime) only. This group will not receive any additional engagement to care intervention.
11232226|NCT02417233|BG001|Baseline|SMS Text Message|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly check-in text messages that will trigger a phone call from clinic staff if the participant reports not being well.~SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages"
11232227|NCT02417233|BG002|Baseline|SMS Text Message + Peer Navigation|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also bi-weekly contact from an HIV-positive peer who provides personalized support and with health or other service systems navigation assistance.~SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation"
11232228|NCT02417233|BG003|Baseline|Total|Total of all reporting groups
11232229|NCT02417233|FG000|Participant Flow|Standard of Care|Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime) only. This group will not receive any additional engagement to care intervention.
11232230|NCT02417233|FG001|Participant Flow|Short Message Service (SMS) Text Message|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly check-in text messages that will trigger a phone call from clinic staff if the participant reports not being well.~SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages"
11232231|NCT02417233|FG002|Participant Flow|Short Message Service (SMS) Text Message + Peer Navigation|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also bi-weekly contact from an HIV-positive peer who provides personalized support and with health or other service systems navigation assistance.~SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation"
11232232|NCT02417233|OG000|Outcome|Standard of Care|Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime) only. This group will not receive any additional engagement to care intervention.
11232233|NCT02417233|OG001|Outcome|Short Message Service (SMS) Text Message|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly check-in text messages that will trigger a phone call from clinic staff if the participant reports not being well.~SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages"
11232234|NCT02417233|OG002|Outcome|SMS Text Message + Peer Navigation|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also bi-weekly contact from an HIV-positive peer who provides personalized support and with health or other service systems navigation assistance.~SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation"
11232235|NCT02417233|OG001|Outcome|SMS Text Message|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly check-in text messages that will trigger a phone call from clinic staff if the participant reports not being well.~SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages"
11232236|NCT02417233|EG000|Reported Event|Standard of Care|Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime) only. This group will not receive any additional engagement to care intervention.
11357298|NCT03760913|BG008|Baseline|20 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg
11168412|NCT01986348|BG002|Baseline|Arm C: Selinexor 60 mg|Participants who were not eligible for surgery received selinexor tablets 60 mg BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168413|NCT01986348|BG003|Baseline|Arm D: Selinexor 80 mg|Participants who were not eligible for surgery received selinexor tablets 80 mg QW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168414|NCT01986348|BG004|Baseline|Total|Total of all reporting groups
11168415|NCT01986348|FG000|Participant Flow|Arm A: Selinexor 60 mg and Surgery|Participants who required surgery received up to 3 doses of oral selinexor tablets 60 milligrams (mg) twice weekly (BIW) on Day 1, Day 3 and between 2 and 48 hours prior to surgery, subsequently underwent surgery for resection of their tumor and resumed selinexor tablets 60 mg BIW after recovery, during Week 1 to 4 of each 4-week cycle, until progression of disease (PD) or development of unacceptable toxicities.
11168416|NCT01986348|FG001|Participant Flow|Arm B: Selinexor 50 mg/m^2|Participants who were not eligible for surgery received selinexor tablets 50 mg per square meter (mg/m^2) BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168417|NCT01986348|FG002|Participant Flow|Arm C: Selinexor 60 mg|Participants who were not eligible for surgery received selinexor tablets 60 mg BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168418|NCT01986348|FG003|Participant Flow|Arm D: Selinexor 80 mg|Participants who were not eligible for surgery received selinexor tablets 80 mg once weekly (QW) during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168419|NCT01986348|OG000|Outcome|Arm B: Selinexor 50 mg/m^2|Participants who were not eligible for surgery received selinexor tablets 50 mg/m^2 BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168420|NCT01986348|OG001|Outcome|Arm C: Selinexor 60 mg|Participants who were not eligible for surgery received selinexor tablets 60 mg BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168421|NCT01986348|OG002|Outcome|Arm D: Selinexor 80 mg|Participants who were not eligible for surgery received selinexor tablets 80 mg QW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168422|NCT01986348|OG000|Outcome|Arm A: Selinexor 60 mg and Surgery|Participants who required surgery received up to 3 doses of oral selinexor tablets 60 mg BIW on Day 1, Day 3 and between 2 and 48 hours prior to surgery, subsequently underwent surgery for resection of their tumor and resumed selinexor tablets 60 mg BIW after recovery, during Week 1 to 4 of each 4-week cycle, until PD or development of unacceptable toxicities.
11168423|NCT01986348|OG001|Outcome|Arm B: Selinexor 50 mg/m^2|Participants who were not eligible for surgery received selinexor tablets 50 mg/m^2 BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168424|NCT01986348|OG002|Outcome|Arm C: Selinexor 60 mg|Participants who were not eligible for surgery received selinexor tablets 60 mg BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168425|NCT01986348|OG003|Outcome|Arm D: Selinexor 80 mg|Participants who were not eligible for surgery received selinexor tablets 80 mg QW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168426|NCT01986348|EG000|Reported Event|Arm A: Selinexor 60 mg and Surgery|Participants who required surgery received up to 3 doses of oral selinexor tablets 60 mg BIW on Day 1, Day 3 and between 2 and 48 hours prior to surgery, subsequently underwent surgery for resection of their tumor and resumed selinexor tablets 60 mg BIW after recovery, during Week 1 to 4 of each 4-week cycle, until PD or development of unacceptable toxicities.
11168427|NCT01986348|EG001|Reported Event|Arm B: Selinexor 50 mg/m^2|Participants who were not eligible for surgery received selinexor tablets 50 mg/m^2 BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168428|NCT01986348|EG002|Reported Event|Arm C: Selinexor 60 mg|Participants who were not eligible for surgery received selinexor tablets 60 mg BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168429|NCT01986348|EG003|Reported Event|Arm D: Selinexor 80 mg|Participants who were not eligible for surgery received selinexor tablets 80 mg QW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
11168430|NCT01986361|BG000|Baseline|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
11168431|NCT01986361|BG001|Baseline|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
11168432|NCT01986361|BG002|Baseline|Total|Total of all reporting groups
11168433|NCT01986361|FG000|Participant Flow|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
11168434|NCT01986361|FG001|Participant Flow|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
11168435|NCT01986361|OG000|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
11168436|NCT01986361|OG001|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
11168437|NCT01986361|EG000|Reported Event|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
11168438|NCT01986361|EG001|Reported Event|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
11168439|NCT01986647|BG000|Baseline|On the Move Exercise Group - Exercise LEader|"On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking.~Exercise class will be led by a person who is trained in exercise such as exercise physiologist, physical therapist, physical therapist assistant On the Move group exercise"
11168440|NCT01986647|BG001|Baseline|Standard Group Exercise Program - Exercise Leader|"Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class.~Exercise class will be led by a person who is trained in exercise such as exercise physiologist, physical therapist, physical therapist assistant Standard group exercise"
11357299|NCT03760913|BG009|Baseline|40 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg
11354457|NCT03865329|EG000|Reported Event|Intervention- Home Pulmonary Rehabilitation|"Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).~Intervention- Home-based Pulmonary Rehabilitation: Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching."
11354458|NCT03864653|BG000|Baseline|MoodGym|"Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., Getting Off) participants who will invited to participate in the study during their enrollment, and can enroll in the study at any time during their first two weeks of program participation. Participants who enroll will take the preexisting, low-intensity MoodGym intervention.~MoodGym: MoodGym is a preexisting Internet-based CBT program that uses interactive content and character-driven narratives to help alleviate symptoms of depression and comorbid anxiety. The program also aims to improve the individual's functioning by promoting the development of skills and strategies to manage depression.~MoodGym consists of an introduction module, five structured intervention modules, and a workbook of assessments. Each MoodGym session takes place entirely on an Internet-connected tablet while in the physical co-presence of a Study Counselor, who can answe"
11354459|NCT03864653|FG000|Participant Flow|MoodGym|"Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., Getting Off) participants who will invited to participate in the study during their enrollment, and can enroll in the study at any time during their first two weeks of program participation. Participants who enroll will take the preexisting, low-intensity MoodGym intervention.~MoodGym: MoodGym is a preexisting Internet-based CBT program that uses interactive content and character-driven narratives to help alleviate symptoms of depression and comorbid anxiety. The program also aims to improve the individual's functioning by promoting the development of skills and strategies to manage depression.~MoodGym consists of an introduction module, five structured intervention modules, and a workbook of assessments. Each MoodGym session takes place entirely on an Internet-connected tablet while in the physical co-presence of a Study Counselor, who can answe"
11354460|NCT03864653|OG000|Outcome|MoodGym|"Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., Getting Off) participants who will invited to participate in the study during their enrollment, and can enroll in the study at any time during their first two weeks of program participation. Participants who enroll will take the preexisting, low-intensity MoodGym intervention.~MoodGym: MoodGym is a preexisting Internet-based CBT program that uses interactive content and character-driven narratives to help alleviate symptoms of depression and comorbid anxiety. The program also aims to improve the individual's functioning by promoting the development of skills and strategies to manage depression.~MoodGym consists of an introduction module, five structured intervention modules, and a workbook of assessments. Each MoodGym session takes place entirely on an Internet-connected tablet while in the physical co-presence of a Study Counselor, who can answe"
11354461|NCT03864653|EG000|Reported Event|MoodGym|"Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., Getting Off) participants who will invited to participate in the study during their enrollment, and can enroll in the study at any time during their first two weeks of program participation. Participants who enroll will take the preexisting, low-intensity MoodGym intervention.~MoodGym: MoodGym is a preexisting Internet-based CBT program that uses interactive content and character-driven narratives to help alleviate symptoms of depression and comorbid anxiety. The program also aims to improve the individual's functioning by promoting the development of skills and strategies to manage depression.~MoodGym consists of an introduction module, five structured intervention modules, and a workbook of assessments. Each MoodGym session takes place entirely on an Internet-connected tablet while in the physical co-presence of a Study Counselor, who can answe"
11354462|NCT03862482|BG000|Baseline|Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1)|Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal), SW (Swede-Vent® dental implant unit) placed at sites 1 (left distal) and 4 (right medial), SC (Screw-Vent® dental implant unit) placed at site 3 (para symphysis) for a total of 40 dental implant units (16 B, 16 SW, 8 SC), all between mandibular foramen
11354463|NCT03862482|BG001|Baseline|Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2)|Device placement: B (Brånemark® dental implant unit) placed at site 3 (para symphysis), SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal), SC (Screw-Vent® dental implant unit) placed at sites 1 (left distal) and 4 (right medial) for a total of 40 dental implant units (eight B, 16 SW, 16 SC), all between mandibular foramen
11354464|NCT03862482|BG002|Baseline|Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)|Device placement: B (Brånemark® dental implant unit) placed at sites 1 (left distal) and 4 (right medial), SW (Swede-Vent® dental implant unit) placed at site 3 (para symphysis), SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) for a total of 30 dental implant units (12 B, six SW, 12 SC), all between mandibular foramen
11354465|NCT03862482|BG003|Baseline|Total|Total of all reporting groups
11354466|NCT03862482|FG000|Participant Flow|Active Comparator: Brånemark® (B) 2, Swede-Vent® (SW) 2, Screw-Vent® (SC) 1 (Configuration 1)|Device: Brånemark® implant placed at sites 2 (left medial) and 5 (right distal), Swede-Vent® implant placed at sites 1 (left distal) and 4 (right medial), Screw-Vent® implant placed at site 3 (para symphysis) between mandibular foramen
11357300|NCT03760913|BG010|Baseline|80 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg
11357301|NCT03760913|BG011|Baseline|160 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg
11354467|NCT03862482|FG001|Participant Flow|Experimental: Brånemark® (B) 1, Swede-Vent® (SW) 2, Screw-Vent® (SC) 2 (Configuration 2)|Device: Brånemark® implant placed at site 3 (para symphysis), Swede-Vent® implant placed at sites 2 (left medial) and 5 (right distal), Screw-Vent® implant placed at sites 1 (left distal) and 4 (right medial) between mandibular foramen
11354468|NCT03862482|FG002|Participant Flow|Experimental: Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)|Device: Brånemark® implant placed at sites 1 (left distal) and 4 (right medial), Swede-Vent® implant placed at site 3 (para symphysis), Screw-Vent® implant placed at sites 2 (left medial) and 5 (right distal) between mandibular foramen
11354469|NCT03862482|OG000|Outcome|All Participants (Configurations 1, 2, and 3)|"Configuration 1: Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal)~Configuration 2: Device placement SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal)~Configuration 3: Device placement SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal)"
11354470|NCT03862482|EG000|Reported Event|Active Comparator: Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1).|Device: Brånemark® implant placed at sites 2 (left medial) and 5 (right distal), Swede-Vent® implant placed at sites 1 (left distal) and 4 (right medial), Screw-Vent® implant placed at site 3 (para symphysis).
11354471|NCT03862482|EG001|Reported Event|Experimental: Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2).|Device: Brånemark® implant placed at site 3 (para symphysis), Swede-Vent® implant placed at sites 2 (left medial) and 5 (right distal), Screw-Vent® implant placed at sites 1 O(left distal) and 4 (right medial).
11354472|NCT03862482|EG002|Reported Event|Experimental: Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3).|Device: Brånemark® implant placed at sites 1 (left distal) and 4 (right medial), Swede-Vent® implant placed at site 3 (para symphysis), Screw-Vent® implant placed at sites 2 (left medial) and 5 (right distal).
11354473|NCT03853213|BG000|Baseline|Cognitive Bias Modification Training|"Participants in this intervention group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is Cognitive Bias Modification Training for Attention. It is designed to reinforce attention away from ACS threat-related stimuli (e.g., death, chest pain) and toward neutral stimuli (e.g., curve, barn doors). The second task is Cognitive Bias Modification Training for Interpretation. It is designed to train participants to appraise ambiguous information that is potentially related to ACS threat as benign.~Cognitive Bias Modification Training: In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The letter appears in the neutral location on 90.6% of trials, thereby reinforcing participants' attending away from threat. In task 2, participants view a word or phrase corresponding to a threatening (e.g., dying) or benign (e.g., sleep) interpretation of a sentence (e.g., You have been waking up tired recently). They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback (Correct) is given for rejected threat interpretations and for benign interpretations. Otherwise, negative feedback (Incorrect) is given."
11354474|NCT03853213|BG001|Baseline|Attention Control Training|"Participants in this placebo control group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is the placebo version of Cognitive Bias Modification Training for Attention. It is designed NOT to train attention toward or away from threatening or neutral information. The second task is the placebo version of Cognitive Bias Modification Training for Interpretation. It is designed NOT to train the interpretation of information as either threatening or benign.~Attention Control Training: In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The target letter is equally likely to appear in the threat location as the neutral location. Thus, participants' patterns of attention are not trained toward or away from threat. In task 2, participants view a word or short phrase corresponding to either a threatening or benign interpretation of a sentence that follows it. They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback and negative feedback are equally likely to be given regardless of whether participants endorse the threatening or benign interpretations."
11354475|NCT03853213|BG002|Baseline|Total|Total of all reporting groups
11357302|NCT03760913|BG012|Baseline|5 x Placebo Part B, Multiple Ascending Dose|Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5
11357303|NCT03760913|BG013|Baseline|5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg
11357304|NCT03760913|BG014|Baseline|5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg
11357305|NCT03760913|BG015|Baseline|5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg
11357306|NCT03760913|BG016|Baseline|5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg
11357307|NCT03760913|BG017|Baseline|5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg
11354476|NCT03853213|FG000|Participant Flow|Cognitive Bias Modification Training|"Participants in this intervention group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is Cognitive Bias Modification Training for Attention. It is designed to reinforce attention away from ACS threat-related stimuli (e.g., death, chest pain) and toward neutral stimuli (e.g., curve, barn doors). The second task is Cognitive Bias Modification Training for Interpretation. It is designed to train participants to appraise ambiguous information that is potentially related to ACS threat as benign.~Cognitive Bias Modification Training: In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The letter appears in the neutral location on 90.6% of trials, thereby reinforcing participants' attending away from threat. In task 2, participants view a word or phrase corresponding to a threatening (e.g., dying) or benign (e.g., sleep) interpretation of a sentence (e.g., You have been waking up tired recently). They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback (Correct) is given for rejected threat interpretations and for benign interpretations. Otherwise, negative feedback (Incorrect) is given."
11354477|NCT03853213|FG001|Participant Flow|Attention Control Training|"Participants in this placebo control group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is the placebo version of Cognitive Bias Modification Training for Attention. It is designed NOT to train attention toward or away from threatening or neutral information. The second task is the placebo version of Cognitive Bias Modification Training for Interpretation. It is designed NOT to train the interpretation of information as either threatening or benign.~Attention Control Training: In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The target letter is equally likely to appear in the threat location as the neutral location. Thus, participants' patterns of attention are not trained toward or away from threat. In task 2, participants view a word or short phrase corresponding to either a threatening or benign interpretation of a sentence that follows it. They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback and negative feedback are equally likely to be given regardless of whether participants endorse the threatening or benign interpretations."
11354478|NCT03853213|OG000|Outcome|Cognitive Bias Modification Training|"Participants in this intervention group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is Cognitive Bias Modification Training for Attention. It is designed to reinforce attention away from ACS threat-related stimuli (e.g., death, chest pain) and toward neutral stimuli (e.g., curve, barn doors). The second task is Cognitive Bias Modification Training for Interpretation. It is designed to train participants to appraise ambiguous information that is potentially related to ACS threat as benign.~Cognitive Bias Modification Training: In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The letter appears in the neutral location on 90.6% of trials, thereby reinforcing participants' attending away from threat. In task 2, participants view a word or phrase corresponding to a threatening (e.g., dying) or benign (e.g., sleep) interpretation of a sentence (e.g., You have been waking up tired recently). They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback (Correct) is given for rejected threat interpretations and for benign interpretations. Otherwise, negative feedback (Incorrect) is given."
11354479|NCT03853213|OG001|Outcome|Attention Control Training|"Participants in this placebo control group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is the placebo version of Cognitive Bias Modification Training for Attention. It is designed NOT to train attention toward or away from threatening or neutral information. The second task is the placebo version of Cognitive Bias Modification Training for Interpretation. It is designed NOT to train the interpretation of information as either threatening or benign.~Attention Control Training: In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The target letter is equally likely to appear in the threat location as the neutral location. Thus, participants' patterns of attention are not trained toward or away from threat. In task 2, participants view a word or short phrase corresponding to either a threatening or benign interpretation of a sentence that follows it. They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback and negative feedback are equally likely to be given regardless of whether participants endorse the threatening or benign interpretations."
11357308|NCT03760913|BG018|Baseline|5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
11357309|NCT03760913|BG019|Baseline|Total|Total of all reporting groups
11357310|NCT03760913|FG000|Participant Flow|Placebo Part A, Single Ascending Dose|Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo
11357311|NCT03760913|FG001|Participant Flow|30 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng
11357312|NCT03760913|FG002|Participant Flow|120 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng
11354480|NCT03853213|EG000|Reported Event|Cognitive Bias Modification Training|"Participants in this intervention group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is Cognitive Bias Modification Training for Attention. It is designed to reinforce attention away from ACS threat-related stimuli (e.g., death, chest pain) and toward neutral stimuli (e.g., curve, barn doors). The second task is Cognitive Bias Modification Training for Interpretation. It is designed to train participants to appraise ambiguous information that is potentially related to ACS threat as benign.~Cognitive Bias Modification Training: In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The letter appears in the neutral location on 90.6% of trials, thereby reinforcing participants' attending away from threat. In task 2, participants view a word or phrase corresponding to a threatening (e.g., dying) or benign (e.g., sleep) interpretation of a sentence (e.g., You have been waking up tired recently). They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback (Correct) is given for rejected threat interpretations and for benign interpretations. Otherwise, negative feedback (Incorrect) is given."
11354481|NCT03853213|EG001|Reported Event|Attention Control Training|"Participants in this placebo control group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is the placebo version of Cognitive Bias Modification Training for Attention. It is designed NOT to train attention toward or away from threatening or neutral information. The second task is the placebo version of Cognitive Bias Modification Training for Interpretation. It is designed NOT to train the interpretation of information as either threatening or benign.~Attention Control Training: In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The target letter is equally likely to appear in the threat location as the neutral location. Thus, participants' patterns of attention are not trained toward or away from threat. In task 2, participants view a word or short phrase corresponding to either a threatening or benign interpretation of a sentence that follows it. They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback and negative feedback are equally likely to be given regardless of whether participants endorse the threatening or benign interpretations."
11354482|NCT03847610|BG000|Baseline|Healthy Volunteer|"Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study~Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed."
11354483|NCT03847610|FG000|Participant Flow|Healthy Volunteer|"Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study~Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed."
11168441|NCT01986647|BG002|Baseline|On the Move Group - STaff Activity Personnel|"On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking.~Exercise class will be led by a member of the facility who does not necessarily have formal exercise training. this person will be trained by the research staff to lead the class.~On the Move group exercise"
11168442|NCT01986647|BG003|Baseline|Standard Program - Staff Activity Personnel|"Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class.~Exercise class will be led by a member of the facility who does not necessarily have formal exercise training. this person will be trained by the research staff to lead the class.~Standard group exercise"
11168443|NCT01986647|BG004|Baseline|Total|Total of all reporting groups
11168444|NCT01986647|FG000|Participant Flow|On the Move Exercise Group - Exercise Leader|"On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking. Taught by exercise leader.~On the Move group exercise"
11168445|NCT01986647|FG001|Participant Flow|Standard Group Exercise Program - Exercise Leader|"Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class. Taught by exercise leader~Standard group exercise"
11168446|NCT01986647|FG002|Participant Flow|On the Move Exercise Program - Staff Activity Personnel|On the Move group exercise - taught by staff activity personnel
11168447|NCT01986647|FG003|Participant Flow|Standard Exercise Program - Staff Activity Personnel|"Standard exercise program taught by a member of the facility who does not necessarily have formal exercise training. this person will be trained by the research staff to lead the class.~Standard group exercise"
11168448|NCT01986647|OG000|Outcome|On the Move Exercise Group - Exercise Leader|"On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking. Taught by exercise leader.~On the Move group exercise"
11168449|NCT01986647|OG001|Outcome|Standard Group Exercise Program - Exercise Leader|"Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class. Taught by exercise leader~Standard group exercise"
11168450|NCT01986647|OG002|Outcome|On the Move Exercise Program - Staff Activity Personnel|On the Move group exercise - taught by staff activity personnel
11168451|NCT01986647|OG003|Outcome|Standard Exercise Program - Staff Activity Personnel|"Standard exercise program taught by a member of the facility who does not necessarily have formal exercise training. this person will be trained by the research staff to lead the class.~Standard group exercise"
11168452|NCT01986647|OG000|Outcome|On the Move Exercise Group - Exercise LEader|"On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking.~Exercise class will be led by a person who is trained in exercise such as exercise physiologist, physical therapist, physical therapist assistant On the Move group exercise"
11357313|NCT03760913|FG003|Participant Flow|400 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng
11354484|NCT03847610|OG000|Outcome|Healthy Volunteer|"Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study~Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed."
11354485|NCT03847610|EG000|Reported Event|Healthy Volunteer|"Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study~Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed."
11354486|NCT03850093|BG000|Baseline|Gabapentin|gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
11354487|NCT03850093|BG001|Baseline|Bisoprolol|bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
11354488|NCT03850093|BG002|Baseline|Control|placebo was given to patients of control group 2 hours preoperative
11354489|NCT03850093|BG003|Baseline|Total|Total of all reporting groups
11354490|NCT03850093|FG000|Participant Flow|Gabapentin Group (Group G)|21 patients completed the study and were considered for statistical analysis
11354491|NCT03850093|FG001|Participant Flow|Bisoprolol Group (Group B)|22 patients were allocated to group B, completed the study and were considered for statistical analysis
11354492|NCT03850093|FG002|Participant Flow|Control Group (Group C)|17 patients completed the study and were considered for statistical analysis
11354493|NCT03850093|OG000|Outcome|Gabapentin|gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
11354494|NCT03850093|OG001|Outcome|Bisoprolol|bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
11354495|NCT03850093|OG002|Outcome|Control|placebo was given to patients of control group 2 hours preoperative
11354496|NCT03850093|EG000|Reported Event|Gabapentin|gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
11354497|NCT03850093|EG001|Reported Event|Bisoprolol|bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
11354498|NCT03850093|EG002|Reported Event|Control|placebo was given to patients of control group 2 hours preoperative
11354499|NCT03848208|BG000|Baseline|Placebo|Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354500|NCT03848208|BG001|Baseline|Cytisine 6 mg|Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354501|NCT03848208|BG002|Baseline|Cytisine 9 mg|Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354502|NCT03848208|BG003|Baseline|Cytisine 12 mg|Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354503|NCT03848208|BG004|Baseline|Cytisine 15 mg|Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354504|NCT03848208|BG005|Baseline|Cytisine 18 mg|Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354505|NCT03848208|BG006|Baseline|Cytisine 21 mg|Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354506|NCT03848208|BG007|Baseline|Cytisine 24 mg|Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354507|NCT03848208|BG008|Baseline|Cytisine 27 mg|Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354508|NCT03848208|BG009|Baseline|Cytisine 30 mg|Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354509|NCT03848208|BG010|Baseline|Total|Total of all reporting groups
11354510|NCT03848208|FG000|Participant Flow|Placebo|Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354511|NCT03848208|FG001|Participant Flow|Cytisine 6 mg|Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354512|NCT03848208|FG002|Participant Flow|Cytisine 9 mg|Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354513|NCT03848208|FG003|Participant Flow|Cytisine 12 mg|Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354514|NCT03848208|FG004|Participant Flow|Cytisine 15 mg|Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354515|NCT03848208|FG005|Participant Flow|Cytisine 18 mg|Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354516|NCT03848208|FG006|Participant Flow|Cytisine 21 mg|Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354517|NCT03848208|FG007|Participant Flow|Cytisine 24 mg|Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354518|NCT03848208|FG008|Participant Flow|Cytisine 27 mg|Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354519|NCT03848208|FG009|Participant Flow|Cytisine 30 mg|Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354520|NCT03848208|OG000|Outcome|Placebo|Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354521|NCT03848208|OG001|Outcome|Cytisine 6 mg|Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354522|NCT03848208|OG002|Outcome|Cytisine 9 mg|Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354523|NCT03848208|OG003|Outcome|Cytisine 12 mg|Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354524|NCT03848208|OG004|Outcome|Cytisine 15 mg|Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354525|NCT03848208|OG005|Outcome|Cytisine 18 mg|Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354526|NCT03848208|OG006|Outcome|Cytisine 21 mg|Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354527|NCT03848208|OG007|Outcome|Cytisine 24 mg|Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354528|NCT03848208|OG008|Outcome|Cytisine 27 mg|Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354529|NCT03848208|OG009|Outcome|Cytisine 30 mg|Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354530|NCT03848208|OG000|Outcome|Cytisine 6 mg|Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354531|NCT03848208|OG001|Outcome|Cytisine 9 mg|Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354532|NCT03848208|OG002|Outcome|Cytisine 12 mg|Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354533|NCT03848208|OG003|Outcome|Cytisine 15 mg|Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354534|NCT03848208|OG004|Outcome|Cytisine 18 mg|Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354535|NCT03848208|OG005|Outcome|Cytisine 21 mg|Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354536|NCT03848208|OG006|Outcome|Cytisine 24 mg|Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354537|NCT03848208|OG007|Outcome|Cytisine 27 mg|Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354538|NCT03848208|OG008|Outcome|Cytisine 30 mg|Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354539|NCT03848208|EG000|Reported Event|Placebo|Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354540|NCT03848208|EG001|Reported Event|Cytisine 6 mg|Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354541|NCT03848208|EG002|Reported Event|Cytisine 9 mg|Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354542|NCT03848208|EG003|Reported Event|Cytisine 12 mg|Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354543|NCT03848208|EG004|Reported Event|Cytisine 15 mg|Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354544|NCT03848208|EG005|Reported Event|Cytisine 18 mg|Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354545|NCT03848208|EG006|Reported Event|Cytisine 21 mg|Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354546|NCT03848208|EG007|Reported Event|Cytisine 24 mg|Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354547|NCT03848208|EG008|Reported Event|Cytisine 27 mg|Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354548|NCT03848208|EG009|Reported Event|Cytisine 30 mg|Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
11354549|NCT03847389|BG000|Baseline|Clobetasol Propionate Topical Oil in Cohort 1|"Cohort 1: ≥12 to <18 years;~At the Baseline/Start of Treatment for Cohort 1, subjects underwent assessments of their AD, baseline (pretreatment) assessments of tolerability criteria, a review of eligibility criteria, a urine pregnancy test and baseline (pretreatment) assessments of AEs. For subjects who remained eligible for the study, the investigator designated the areas to be treated with study drug, and subjects and/or their caregivers applied the first dose of study drug at the site. AEs and tolerability were assessed."
11354550|NCT03847389|BG001|Baseline|Clobetasol Propionate Topical Oil in Cohort 2|"Cohort 2: ≥6 to <12 years;~Enrollment from Cohort 1 into Cohort 2 will proceed only after cohort 1 had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354551|NCT03847389|BG002|Baseline|Clobetasol Propionate Topical Oil in Cohort 3|"Cohort 3: ≥2 to <6 years~Enrollment from Cohort 2 into Cohort 3 will proceed only after cohort 2 had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11168453|NCT01986647|OG001|Outcome|Standard Group Exercise Program - Exercise Leader|"Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class.~Exercise class will be led by a person who is trained in exercise such as exercise physiologist, physical therapist, physical therapist assistant Standard group exercise"
11168454|NCT01986647|OG002|Outcome|On the Move Group - STaff Activity Personnel|"On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking.~Exercise class will be led by a member of the facility who does not necessarily have formal exercise training. this person will be trained by the research staff to lead the class.~On the Move group exercise"
11168455|NCT01986647|OG003|Outcome|Standard Program - Staff Activity Personnel|"Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class.~Exercise class will be led by a member of the facility who does not necessarily have formal exercise training. this person will be trained by the research staff to lead the class.~Standard group exercise"
11168456|NCT01986647|EG000|Reported Event|On the Move Exercise - Exercise Leader|"On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking. Led by exercise leader~On the Move exercise - exercise leader: exercise physiologists"
11168457|NCT01986647|EG001|Reported Event|Standard Program - Exercise Leader|"Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class. Led by exercise leader~Standard program - exercise leader: This is an impairment-based exercise program focusing on flexibility, strength and endurance and is taught by research staff who are PTs, PTAs, or exercise physiologists"
11168458|NCT01986647|EG002|Reported Event|On the Move - Staff Activity Personnel|"On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking. Led by activity personnel.~On the Move exercise - staff activity personnel: this is a group exercise program focusing on the timing and coordination of walking. The program is taught by a person from the facility that the research team trained."
11168459|NCT01986647|EG003|Reported Event|Standard - Staff Activity Personnel|"Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class. Led by staff activity personnel~Standard program - staff activity personnel: This is an impairment-based exercise program focusing on flexibility, strength and endurance and is taught by a member of the facility that the research staff trained."
11168460|NCT01986686|BG000|Baseline|Observational|The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
11168461|NCT01986686|BG001|Baseline|Surgery|"The surgery group will be offered colon resection.~Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease."
11168462|NCT01986686|BG002|Baseline|Total|Total of all reporting groups
11168463|NCT01986686|FG000|Participant Flow|Observational|The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
11168464|NCT01986686|FG001|Participant Flow|Surgery|"The surgery group will be offered colon resection.~Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease."
11168465|NCT01986686|OG000|Outcome|Observational|The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
11168466|NCT01986686|OG001|Outcome|Surgery|"The surgery group will be offered colon resection.~Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease."
11168467|NCT01986686|EG000|Reported Event|Observational|The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
11168468|NCT01986686|EG001|Reported Event|Surgery|"The surgery group will be offered colon resection.~Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease."
11168469|NCT01986790|BG000|Baseline|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
11168470|NCT01986790|BG001|Baseline|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
11168471|NCT01986790|BG002|Baseline|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
11168472|NCT01986790|BG003|Baseline|Total|Total of all reporting groups
11168473|NCT01986790|FG000|Participant Flow|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
11168474|NCT01986790|FG001|Participant Flow|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
11168475|NCT01986790|FG002|Participant Flow|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
11168476|NCT01986790|OG000|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
11168477|NCT01986790|OG001|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
11168478|NCT01986790|OG002|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
11354552|NCT03847389|BG003|Baseline|Total|Total of all reporting groups
11168479|NCT01986790|EG000|Reported Event|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
11168480|NCT01986790|EG001|Reported Event|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
11168481|NCT01986790|EG002|Reported Event|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
11168482|NCT01986829|BG000|Baseline|Treatment (Ablation)|"Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.~Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)"
11168483|NCT01986829|FG000|Participant Flow|Treatment (Ablation)|"Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.~Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)"
11168484|NCT01986829|OG000|Outcome|Treatment (Ablation)|"Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.~Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)"
11168485|NCT01986829|OG000|Outcome|Pre-treatment|"Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.~Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)"
11168486|NCT01986829|OG001|Outcome|Post-Treatment|"Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.~Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)"
11168487|NCT01986829|OG002|Outcome|Disease Progression|"Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.~Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)"
11168488|NCT01986829|EG000|Reported Event|Treatment (Ablation)|"Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.~Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)"
11168489|NCT01986855|BG000|Baseline|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
11168490|NCT01986855|BG001|Baseline|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
11168491|NCT01986855|BG002|Baseline|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
11168492|NCT01986855|BG003|Baseline|Total|Total of all reporting groups
11168493|NCT01986855|FG000|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
11168494|NCT01986855|FG001|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
11357314|NCT03760913|FG004|Participant Flow|1.2 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg
11168495|NCT01986855|FG002|Participant Flow|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
11168496|NCT01986855|OG000|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
11168497|NCT01986855|OG001|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
11168498|NCT01986855|OG002|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
11168499|NCT01986855|EG000|Reported Event|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
11168500|NCT01986855|EG001|Reported Event|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
11168501|NCT01986855|EG002|Reported Event|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
11168502|NCT01986881|BG000|Baseline|Ertugliflozin 5 mg (Overall Cardiovascular Study)|Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
11168503|NCT01986881|BG001|Baseline|Ertugliflozin 15 mg (Overall Cardiovascular Study)|Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
11168504|NCT01986881|BG002|Baseline|Placebo (Overall Cardiovascular Study)|Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
11168505|NCT01986881|BG003|Baseline|Total|Total of all reporting groups
11168506|NCT01986881|FG000|Participant Flow|Ertugliflozin 5 mg (Overall Cardiovascular Study)|Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
11168507|NCT01986881|FG001|Participant Flow|Ertugliflozin 15 mg (Overall Cardiovascular Study)|Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
11168508|NCT01986881|FG002|Participant Flow|Placebo (Overall Cardiovascular Study)|Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
11168509|NCT01986881|OG000|Outcome|Ertugliflozin 5 mg (Overall Cardiovascular Study)|Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
11168510|NCT01986881|OG001|Outcome|Ertugliflozin 15 mg (Overall Cardiovascular Study)|Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
11168511|NCT01986881|OG002|Outcome|Placebo (Overall Cardiovascular Study)|Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
11168512|NCT01986881|OG003|Outcome|All Ertugliflozin (Overall Cardiovascular Study)|Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
11168513|NCT01986881|OG000|Outcome|Ertugliflozin 5 mg (Insulin +/- Metformin Glycemic Sub-study)|Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
11168514|NCT01986881|OG001|Outcome|Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study)|Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
11354553|NCT03847389|FG000|Participant Flow|Clobetasol Propionate Topical Oil in Cohort 1|"Cohort 1: ≥12 to <18 years;~Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354554|NCT03847389|FG001|Participant Flow|Clobetasol Propionate Topical Oil in Cohort 2|"Cohort 2: ≥6 to <12 years;~Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354555|NCT03847389|FG002|Participant Flow|Clobetasol Propionate Topical Oil in Cohort 3|"Cohort 3: ≥2 to <6 years~Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354556|NCT03847389|OG000|Outcome|Clobetasol Propionate Topical Oil in Cohort 1|"Cohort 1: ≥12 to <18 years;~Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354557|NCT03847389|OG001|Outcome|Clobetasol Propionate Topical Oil in Cohort 2|"Cohort 2: ≥6 to <12 years;~Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354558|NCT03847389|OG002|Outcome|Clobetasol Propionate Topical Oil in Cohort 3|"Cohort 3: ≥2 to <6 years~Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354559|NCT03847389|OG000|Outcome|Clobetasol Propionate Topical Oil in Cohort 1|"Cohort 1: ≥12 to <18 years;~At the Baseline/Start of Treatment for Cohort 1, subjects underwent assessments of their AD, baseline (pretreatment) assessments of tolerability criteria, a review of eligibility criteria, a urine pregnancy test and baseline (pretreatment) assessments of AEs. For subjects who remained eligible for the study, the investigator designated the areas to be treated with study drug, and subjects and/or their caregivers applied the first dose of study drug at the site. AEs and tolerability were assessed."
11354560|NCT03847389|OG001|Outcome|Clobetasol Propionate Topical Oil in Cohort 2|"Cohort 2: ≥6 to <12 years;~Enrollment from Cohort 1 into Cohort 2 will proceed only after cohort 1 had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354561|NCT03847389|OG002|Outcome|Clobetasol Propionate Topical Oil in Cohort 3|"Cohort 3: ≥2 to <6 years~Enrollment from Cohort 2 into Cohort 3 will proceed only after cohort 2 had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11357315|NCT03760913|FG005|Participant Flow|3 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg
11168515|NCT01986881|OG002|Outcome|Placebo (Ins+/-Met Sub-study)|Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
11354562|NCT03847389|EG000|Reported Event|Clobetasol Propionate Topical Oil in Cohort 1|"Cohort 1: ≥12 to <18 years;~At the Baseline/Start of Treatment for Cohort 1, subjects underwent assessments of their AD, baseline (pretreatment) assessments of tolerability criteria, a review of eligibility criteria, a urine pregnancy test and baseline (pretreatment) assessments of AEs. For subjects who remained eligible for the study, the investigator designated the areas to be treated with study drug, and subjects and/or their caregivers applied the first dose of study drug at the site. AEs and tolerability were assessed."
11354563|NCT03847389|EG001|Reported Event|Clobetasol Propionate Topical Oil in Cohort 2|"Cohort 2: ≥6 to <12 years;~Enrollment from Cohort 1 into Cohort 2 will proceed only after cohort 1 had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354564|NCT03847389|EG002|Reported Event|Clobetasol Propionate Topical Oil in Cohort 3|"Cohort 3: ≥2 to <6 years~Enrollment from Cohort 2 into Cohort 3 will proceed only after cohort 2 had been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin."
11354565|NCT03862040|BG000|Baseline|Cefiderocol|Participants received 2 g cefiderocol (or renally adjusted doses) every 8 hours (or every 6 hours for participants with augmented renal function), administered by intravenous infusion over 3 hours for a total of 3 to 6 doses.
11354566|NCT03862040|FG000|Participant Flow|Cefiderocol|Participants received 2 g cefiderocol (or renally adjusted doses) every 8 hours (or every 6 hours for participants with augmented renal function), administered by intravenous infusion over 3 hours for a total of 3 to 6 doses.
11354567|NCT03862040|OG000|Outcome|Cefiderocol|Participants received 2 g cefiderocol (or renally adjusted doses) every 8 hours (or every 6 hours for participants with augmented renal function), administered by intravenous infusion over 3 hours for a total of 3 to 6 doses.
11354568|NCT03862040|EG000|Reported Event|Cefiderocol|Participants received 2 g cefiderocol (or renally adjusted doses) every 8 hours (or every 6 hours for participants with augmented renal function), administered by intravenous infusion over 3 hours for a total of 3 to 6 doses.
11354569|NCT03861936|BG000|Baseline|Placebo|Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
11354570|NCT03861936|BG001|Baseline|BOTOX® 48U|OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
11354571|NCT03861936|BG002|Baseline|BOTOX® 72U|OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
11354572|NCT03861936|BG003|Baseline|Total|Total of all reporting groups
11168516|NCT01986881|OG000|Outcome|Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)|Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
11168517|NCT01986881|OG001|Outcome|Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)|Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
11354573|NCT03861936|FG000|Participant Flow|Placebo|Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
11354574|NCT03861936|FG001|Participant Flow|BOTOX® 48U|OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
11354575|NCT03861936|FG002|Participant Flow|BOTOX® 72U|OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
11354576|NCT03861936|OG000|Outcome|Placebo|Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
11354577|NCT03861936|OG001|Outcome|BOTOX® 48U|OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
11354578|NCT03861936|OG002|Outcome|BOTOX® 72U|OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
11354579|NCT03861936|EG000|Reported Event|Placebo|Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
11354580|NCT03861936|EG001|Reported Event|BOTOX® 48U|OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
11354581|NCT03861936|EG002|Reported Event|BOTOX® 72U|OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
11354582|NCT03859739|BG000|Baseline|MK-8558 400 mg|Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast.
11354583|NCT03859739|BG001|Baseline|MK-8558 900 mg|Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast.
11354584|NCT03859739|BG002|Baseline|MK-8558 1600 mg|Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast.
11354585|NCT03859739|BG003|Baseline|MK-8558 900 mg Low-Fat|Single oral dose of MK-8558 administered at 900 mg following a low-fat meal.
11354586|NCT03859739|BG004|Baseline|Total|Total of all reporting groups
11354587|NCT03859739|FG000|Participant Flow|MK-8558 400 mg|Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast.
11354588|NCT03859739|FG001|Participant Flow|MK-8558 900 mg|Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast.
11354589|NCT03859739|FG002|Participant Flow|MK-8558 1600 mg|Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast.
11354590|NCT03859739|FG003|Participant Flow|MK-8558 900 mg Low-Fat|Single oral dose of MK-8558 administered at 900 mg following a low-fat meal.
11354591|NCT03859739|OG000|Outcome|MK-8558 400 mg|Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast.
11354592|NCT03859739|OG001|Outcome|MK-8558 900 mg|Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast.
11354593|NCT03859739|OG002|Outcome|MK-8558 1600 mg|Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast.
11354594|NCT03859739|OG003|Outcome|MK-8558 900 mg Low-Fat|Single oral dose of MK-8558 administered at 900 mg following a low-fat meal.
11354595|NCT03859739|EG000|Reported Event|MK-8558 400 mg|Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast.
11354596|NCT03859739|EG001|Reported Event|MK-8558 900 mg|Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast.
11354597|NCT03859739|EG002|Reported Event|MK-8558 1600 mg|Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast.
11354598|NCT03859739|EG003|Reported Event|MK-8558 900 mg Low-Fat|Single oral dose of MK-8558 administered at 900 mg following a low-fat meal.
11354599|NCT03857750|BG000|Baseline|Elderly (>80 Years)|"16 patients planned for elective surgery above 80 years~Rocuronium: 0.6 mg/kg"
11354600|NCT03857750|BG001|Baseline|Younger (18-40 Years)|"16 patients planned for elective surgery between 18-40 years~Rocuronium: 0.6 mg/kg"
11354601|NCT03857750|BG002|Baseline|Total|Total of all reporting groups
11354602|NCT03857750|FG000|Participant Flow|Elderly (>80 Years)|"16 patients planned for elective surgery above 80 years~Rocuronium: 0.6 mg/kg"
11354603|NCT03857750|FG001|Participant Flow|Younger (18-40 Years)|"16 patients planned for elective surgery between 18-40 years~Rocuronium: 0.6 mg/kg"
11354604|NCT03857750|OG000|Outcome|Elderly (>80 Years)|"16 patients planned for elective surgery above 80 years~Rocuronium: 0.6 mg/kg"
11354605|NCT03857750|OG001|Outcome|Younger (18-40 Years)|"16 patients planned for elective surgery between 18-40 years~Rocuronium: 0.6 mg/kg"
11354606|NCT03857750|EG000|Reported Event|Elderly (>80 Years)|"16 patients planned for elective surgery above 80 years~Rocuronium: 0.6 mg/kg"
11354607|NCT03857750|EG001|Reported Event|Younger (18-40 Years)|"16 patients planned for elective surgery between 18-40 years~Rocuronium: 0.6 mg/kg"
11354608|NCT03856255|BG000|Baseline|Micro-Tech Endoscopic Gauge|"Use of the device during screening or surveillance colonoscopy~Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy."
11354609|NCT03856255|FG000|Participant Flow|Micro-Tech Endoscopic Gauge|"Use of the device during screening or surveillance colonoscopy~Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy."
11354610|NCT03856255|OG000|Outcome|Micro-Tech Endoscopic Gauge|"Use of the device during screening or surveillance colonoscopy~Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy."
11354611|NCT03856255|EG000|Reported Event|Micro-Tech Endoscopic Gauge|"Use of the device during screening or surveillance colonoscopy~Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy."
11354612|NCT03850509|BG000|Baseline|OPS-2071 300 mg BID|Participants received OPS-2071 300 mg, tablets, orally, twice daily (BID) in the morning and evening (8 to 12 hours apart) with 240 milliliters (mL) of water for up to 6 weeks.
11354613|NCT03850509|BG001|Baseline|Placebo|Participants received OPS-2071-matched placebo, tablets, orally, BID in morning and evening (8 to 12 hours apart) with 240 mL of water for up to 4 weeks.
11354614|NCT03850509|BG002|Baseline|Total|Total of all reporting groups
11354615|NCT03850509|FG000|Participant Flow|OPS-2071 300 mg BID|Participants received OPS-2071 300 mg, tablets, orally, twice daily (BID) in the morning and evening (8 to 12 hours apart) with 240 milliliters (mL) of water for up to 6 weeks.
11354616|NCT03850509|FG001|Participant Flow|Placebo|Participants received OPS-2071-matched placebo, tablets, orally, BID in morning and evening (8 to 12 hours apart) with 240 mL of water for up to 4 weeks.
11354617|NCT03850509|OG000|Outcome|OPS-2071 300 mg BID|Participants received OPS-2071 300 mg, tablets, orally, twice daily (BID) in the morning and evening (8 to 12 hours apart) with 240 milliliters (mL) of water for up to 6 weeks.
11354618|NCT03850509|OG001|Outcome|Placebo|Participants received OPS-2071-matched placebo, tablets, orally, BID in morning and evening (8 to 12 hours apart) with 240 mL of water for up to 4 weeks.
11354619|NCT03850509|EG000|Reported Event|OPS-2071 300 mg BID|Participants received OPS-2071 300 mg, tablets, orally, twice daily (BID) in the morning and evening (8 to 12 hours apart) with 240 milliliters (mL) of water for up to 6 weeks.
11354620|NCT03850509|EG001|Reported Event|Placebo|Participants received OPS-2071-matched placebo, tablets, orally, BID in morning and evening (8 to 12 hours apart) with 240 mL of water for up to 4 weeks.
11354621|NCT03860753|BG000|Baseline|Pioglitazone|Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
11354622|NCT03860753|BG001|Baseline|Placebo|Placebo: Pill capsules will look same as that of active drug.
11354623|NCT03860753|BG002|Baseline|Total|Total of all reporting groups
11354624|NCT03860753|FG000|Participant Flow|Pioglitazone|Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
11354625|NCT03860753|FG001|Participant Flow|Placebo|Placebo: Pill capsules will look same as that of active drug.
11354626|NCT03860753|OG000|Outcome|Pioglitazone|Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
11354627|NCT03860753|OG001|Outcome|Placebo|Placebo: Pill capsules will look same as that of active drug.
11354628|NCT03860753|EG000|Reported Event|Pioglitazone|Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
11354629|NCT03860753|EG001|Reported Event|Placebo|Placebo: Pill capsules will look same as that of active drug.
11357316|NCT03760913|FG006|Participant Flow|6 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg
11357317|NCT03760913|FG007|Participant Flow|12 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg
11168518|NCT01986881|OG002|Outcome|Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)|Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
11168519|NCT01986881|OG000|Outcome|Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study)|Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
11168520|NCT01986881|OG001|Outcome|Ertugliflozin 15 mg (Metformin With Sulfonylurea Glycemic Sub-study)|Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
11168521|NCT01986881|OG002|Outcome|Placebo (Metformin With Sulfonylurea Glycemic Sub-study)|Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
11168522|NCT01986881|OG002|Outcome|Placebo (Insulin +/- Metformin Glycemic Sub-study)|Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
11168523|NCT01986881|OG000|Outcome|Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-study)|Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
11168524|NCT01986881|OG001|Outcome|Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-study)|Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
11168525|NCT01986881|OG002|Outcome|Placebo (Sulfonylurea Monotherapy Glycemic Sub-study)|Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
11168526|NCT01986881|EG000|Reported Event|Ertugliflozin 5 mg (Overall Cardiovascular Study)|Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
11168527|NCT01986881|EG001|Reported Event|Ertugliflozin 15 mg (Overall Cardiovascular Study)|Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
11168528|NCT01986881|EG002|Reported Event|Placebo (Overall Cardiovascular Study)|Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
11168529|NCT01986881|EG003|Reported Event|Ertugliflozin 5 mg (Insulin +/- Metformin Sub-study)|Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
11168530|NCT01986881|EG004|Reported Event|Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study)|Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
11168531|NCT01986881|EG005|Reported Event|Placebo (Insulin +/- Metformin Glycemic Sub-study)|Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
11168532|NCT01986881|EG006|Reported Event|Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)|Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
11168533|NCT01986881|EG007|Reported Event|Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)|Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
11168534|NCT01986881|EG008|Reported Event|Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)|Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
11168535|NCT01986881|EG009|Reported Event|Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study)|Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
11168536|NCT01986881|EG010|Reported Event|Ertugliflozin 15 mg (Metformin With Sulfonylurea Glycemic Sub-study)|Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
11168537|NCT01986881|EG011|Reported Event|Placebo (Metformin With Sulfonylurea Glycemic Sub-study)|Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
11168538|NCT01986907|BG000|Baseline|Ranibizumab|patients treated with 0.5mg ranibizumab
11168539|NCT01986907|FG000|Participant Flow|Ranibizumab|patients treated with 0.5mg ranibizumab
11168540|NCT01986907|OG000|Outcome|Ranibizumab|patients treated with 0.5mg ranibizumab
11168541|NCT01986907|OG000|Outcome|Ranibizumab Overall|patients treated with 0.5mg ranibizumab
11168542|NCT01986907|OG001|Outcome|Unilaterally Treted|
11168543|NCT01986907|OG002|Outcome|Bilaterally Treated|
11168544|NCT01986907|EG000|Reported Event|Ranibizumab 0.5 mg|Ranibizumab 0.5 mg
11168545|NCT01986920|BG000|Baseline|Entire Study Population|Subjects were required to have 4 Target Seborrheic Keratosis Lesions their back. Each lesion was treated with one of the four treatment interventions (A-101 Solution 25%, A-101, Solution 32.5%, A-101 Solution 40% and the A-101 Solution Vehicle) in a randomized fashion.
11168546|NCT01986920|FG000|Participant Flow|A-101 25%|"Low dose group~A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions"
11168547|NCT01986920|FG001|Participant Flow|A-101 32.5%|"Mid Dose Group~A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions"
11168548|NCT01986920|FG002|Participant Flow|A-101 40%|"High Dose Group~A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions"
11168549|NCT01986920|FG003|Participant Flow|A-101 Vehicle|"Placebo group~A-101 Vehicle: Placebo applied to one of 4 Target Lesions"
11168550|NCT01986920|OG000|Outcome|A-101 25%|"Low dose group~A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions"
11168551|NCT01986920|OG001|Outcome|A-101 32.5%|"Mid Dose Group~A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions"
11168552|NCT01986920|OG002|Outcome|A-101 40%|"High Dose Group~A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions"
11168553|NCT01986920|OG003|Outcome|A-101 Vehicle|"Placebo group~A-101 Vehicle: Placebo applied to one of 4 Target Lesions"
11168554|NCT01986920|EG000|Reported Event|A-101 25%|"Low dose group~A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions"
11168555|NCT01986920|EG001|Reported Event|A-101 32.5%|"Mid Dose Group~A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions"
11168556|NCT01986920|EG002|Reported Event|A-101 40%|"High Dose Group~A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions"
11168557|NCT01986920|EG003|Reported Event|A-101 Vehicle|"Placebo group~A-101 Vehicle: Placebo applied to one of 4 Target Lesions"
11168558|NCT01986946|BG000|Baseline|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
11357318|NCT03760913|FG008|Participant Flow|20 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg
11168559|NCT01986946|BG001|Baseline|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
11168560|NCT01986946|BG002|Baseline|Total|Total of all reporting groups
11168561|NCT01986946|FG000|Participant Flow|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
11168562|NCT01986946|FG001|Participant Flow|Epidural Catheter|"The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.~Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery."
11168563|NCT01986946|OG000|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
11168564|NCT01986946|OG001|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
11168565|NCT01986946|EG000|Reported Event|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
11168566|NCT01986946|EG001|Reported Event|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
11168567|NCT01986985|BG000|Baseline|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
11168568|NCT01986985|FG000|Participant Flow|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
11168569|NCT01986985|OG000|Outcome|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
11168570|NCT01986985|EG000|Reported Event|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
11168571|NCT01987089|BG000|Baseline|Cognitive Behavioral Therapy for Insomnia|"Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 & 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.~Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician."
11168572|NCT01987089|BG001|Baseline|Quasi Desensitization Therapy|"This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate conditioned arousal, occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.~Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician."
11168573|NCT01987089|BG002|Baseline|Total|Total of all reporting groups
11168574|NCT01987089|FG000|Participant Flow|Cognitive Behavioral Therapy for Insomnia (CBT-I)|"Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 & 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.~Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician."
11174158|NCT02019927|EG000|Reported Event|Non-arteritic Ischemic Optic Neuropathy|"Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11168575|NCT01987089|FG001|Participant Flow|Quasi Desensitization Therapy (QDT)|"This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate conditioned arousal, occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.~Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician."
11168576|NCT01987089|OG000|Outcome|Cognitive Behavioral Therapy for Insomnia (CBT-I)|"Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 & 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.~Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician."
11168577|NCT01987089|OG001|Outcome|Quasi Desensitization Therapy (QDT)|"This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate conditioned arousal, occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.~Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician."
11168578|NCT01987089|EG000|Reported Event|Cognitive Behavioral Therapy for Insomnia (CBT-I)|"Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 & 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.~Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician."
11168579|NCT01987089|EG001|Reported Event|Quasi Desensitization Therapy (QDT)|"This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate conditioned arousal, occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.~Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician."
11168580|NCT01987102|BG000|Baseline|Cohort 1|"1 MAP cycle (incl. 2 HDMTX courses with Calcium Folinate (SOC) rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with Modufolin (MOD) rescue 15mg/m2)~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11168581|NCT01987102|BG001|Baseline|Cohort 2|"1 MAP cycle (incl. 2 HDMTX courses with Calcium Folinate (SOC) rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with Modufolin (MOD) rescue 7.5mg/m2)~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11168582|NCT01987102|BG002|Baseline|Total|Total of all reporting groups
11168583|NCT01987102|FG000|Participant Flow|Cohort 1|"1 MAP cycle (incl. 2 HDMTX courses with Calcium Folinate (SOC) rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with Modufolin (MOD) rescue 15mg/m2)~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11168584|NCT01987102|FG001|Participant Flow|Cohort 2|"1 MAP cycle (incl. 2 HDMTX courses with Calcium Folinate (SOC) rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with Modufolin (MOD) rescue 7.5mg/m2)~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11174159|NCT02019927|EG001|Reported Event|Sham - Non-arteritic Ischemic Optic Neuropathy|Sham treatment of decreased vision due to NAION
11357319|NCT03760913|FG009|Participant Flow|40 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg
11168585|NCT01987102|OG000|Outcome|Cohort 1|"1 MAP cycle (incl. 2 HDMTX courses with Calcium Folinate (SOC) rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with Modufolin (MOD) rescue 15mg/m2)~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11168586|NCT01987102|OG001|Outcome|Cohort 2|"1 MAP cycle (incl. 2 HDMTX courses with SOC rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with MOD rescue 7.5mg/m2)~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11168587|NCT01987102|OG001|Outcome|Cohort 2|"1 MAP cycle (incl. 2 HDMTX courses with Calcium Folinate (SOC) rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with Modufolin (MOD) rescue 7.5mg/m2)~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11168588|NCT01987102|EG000|Reported Event|Cohort 1|"1 MAP cycle (incl. 2 HDMTX courses with SOC rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with MOD rescue 15mg/m2)~SOC was administered as rescue in the 2 first HDMTX courses and MOD in the 2 following courses.~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11168589|NCT01987102|EG001|Reported Event|Cohort 2|"1 MAP cycle (incl. 2 HDMTX courses with SOC rescue 15mg/m2)~1 MAP cycle (incl. 2 HDMTX courses with MOD rescue 7.5mg/m2)~SOC was administered as rescue in the 2 first HDMTX courses and MOD in the 2 following courses.~Treatment according to the MAP schedule applied. SOC or MOD commenced 24 h after administration of HDMTX and then every 6 h until the serum-MTX levels were ≤ 0.1 µmol/L, in accordance with COG management recommendations."
11168590|NCT01987219|BG000|Baseline|Ipratropium; Alubterol; Placebo|
11168591|NCT01987219|BG001|Baseline|Albuterol; Placebo; Ipratropium|
11168592|NCT01987219|BG002|Baseline|Albuterol; Ipratropium; Placebo|
11168593|NCT01987219|BG003|Baseline|Placebo; Ipratropium; Albuterol|
11168594|NCT01987219|BG004|Baseline|Placebo; Albuterol; Ipratropium|
11168595|NCT01987219|BG005|Baseline|Ipratropium; Placebo; Albuterol|
11168596|NCT01987219|BG006|Baseline|Total|Total of all reporting groups
11168597|NCT01987219|FG000|Participant Flow|Ipratropium; Alubterol; Placebo|Participants in this group received ipratropium followed by albuterol followed by placebo
11168598|NCT01987219|FG001|Participant Flow|Albuterol; Placebo; Ipratropium|Participants in this group received albuterol followed by placebo followed by ipratropium
11168599|NCT01987219|FG002|Participant Flow|Albuterol; Ipratropium; Placebo|Participants in this group received albuterol followed by ipratropium followed by placebo
11168600|NCT01987219|FG003|Participant Flow|Placebo; Ipratropium; Albuterol|Participants in this group received placebo followed by ipratropium followed by albuterol
11168601|NCT01987219|FG004|Participant Flow|Placebo; Albuterol; Ipratropium|Participants in this group received placebo followed by albuterol followed by ipratropium
11168602|NCT01987219|FG005|Participant Flow|Ipratropium; Placebo; Albuterol|Participants in this group received ipratropium followed by placebo followed by albuterol
11168603|NCT01987219|OG000|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 - 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 - 30 mins. Mean duration of effect 3 hours"
11168604|NCT01987219|OG001|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 - 90 mins. Duration of effect 2 - 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 - 90 mins. Duration of effect 2 - 4 hours."
11168605|NCT01987219|OG002|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
11168606|NCT01987219|EG000|Reported Event|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 - 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 - 30 mins. Mean duration of effect 3 hours"
11168607|NCT01987219|EG001|Reported Event|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 - 90 mins. Duration of effect 2 - 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 - 90 mins. Duration of effect 2 - 4 hours."
11168608|NCT01987219|EG002|Reported Event|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
11168609|NCT01987232|BG000|Baseline|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168610|NCT01987232|BG001|Baseline|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168611|NCT01987232|BG002|Baseline|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168612|NCT01987232|BG003|Baseline|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168613|NCT01987232|BG004|Baseline|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168614|NCT01987232|BG005|Baseline|Total|Total of all reporting groups
11168615|NCT01987232|FG000|Participant Flow|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target area under the curve (AUC) of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168616|NCT01987232|FG001|Participant Flow|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168617|NCT01987232|FG002|Participant Flow|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168618|NCT01987232|FG003|Participant Flow|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168619|NCT01987232|FG004|Participant Flow|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168620|NCT01987232|OG000|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168621|NCT01987232|OG001|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168622|NCT01987232|OG002|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168623|NCT01987232|OG003|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168624|NCT01987232|OG004|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168625|NCT01987232|OG005|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168626|NCT01987232|OG005|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target area AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11232237|NCT02417233|EG001|Reported Event|SMS Text Message|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly check-in text messages that will trigger a phone call from clinic staff if the participant reports not being well.~SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages"
11232238|NCT02417233|EG002|Reported Event|SMS Text Message + Peer Navigation|"Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also bi-weekly contact from an HIV-positive peer who provides personalized support and with health or other service systems navigation assistance.~SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation"
11232239|NCT02417246|BG000|Baseline|Sequence A: Brand Name Metoprolol ER and Generic B|"This group will start with the brand name metoprolol ER for 7 to 28 days, and then switch to Generic B metoprolol for 7 days.~Brand name metoprolol ER: This medication will be taken for 7 to 28 days~Generic B metoprolol: This medication will be taken for 7 days~Generic A metoprolol: This medication will be taken for 7 days"
11232240|NCT02417246|BG001|Baseline|Sequence B: Brand Name Metoprolol ER and Generic A|"This group will start with the brand name metoprolol ER for 7 to 28 days, and then switch to Generic A metoprolol for 7 days.~Brand name metoprolol ER: This medication will be taken for 7 to 28 days~Generic A metoprolol: This medication will be taken for 7 days~Generic B metoprolol: This medication will be taken for 7 days"
11232241|NCT02417246|BG002|Baseline|Total|Total of all reporting groups
11232242|NCT02417246|FG000|Participant Flow|Sequence A|Brand name metoprolol ER for 7 to 28 days, and then switch to generic B metoprolol for 7 days, Brand name metoprolol ER for 7 to 28 days, generic A metoprolol for 7 days
11232243|NCT02417246|FG001|Participant Flow|Sequence B|Brand name metoprolol ER for 7 to 28 days, and then switch to generic A metoprolol for 7 days, Brand name metoprolol ER for 7 to 28 days, generic B metoprolol for 7 days
11232244|NCT02417246|OG000|Outcome|Brand Name Metoprolol ER|Brand name metoprolol ER received in Phase 1
11232245|NCT02417246|OG001|Outcome|Generic B|Generic B received in Phase 2 or Phase 4
11232246|NCT02417246|OG002|Outcome|Generic A|Generic A received in Phase 2 or Phase 4
11232247|NCT02417246|EG000|Reported Event|Brand Name|Brand Name Metoprolol ER
11232248|NCT02417246|EG001|Reported Event|Generic A|Generic Metoprolol ER type A
11232249|NCT02417246|EG002|Reported Event|Generic B|Generic Metoprolol ER type B
11232250|NCT02417376|BG000|Baseline|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
11232251|NCT02417376|BG001|Baseline|Control|No periodontal intervention in any form.
11232252|NCT02417376|BG002|Baseline|Total|Total of all reporting groups
11232253|NCT02417376|FG000|Participant Flow|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
11232254|NCT02417376|FG001|Participant Flow|Control|No periodontal intervention in any form.
11232255|NCT02417376|OG000|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
11232256|NCT02417376|OG001|Outcome|Control|No periodontal intervention in any form.
11335573|NCT03552757|FG001|Participant Flow|Semaglutide 2.4 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11168627|NCT01987232|EG000|Reported Event|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168628|NCT01987232|EG001|Reported Event|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168629|NCT01987232|EG002|Reported Event|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168630|NCT01987232|EG003|Reported Event|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168631|NCT01987232|EG004|Reported Event|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
11168632|NCT01987349|BG000|Baseline|Group A: Age 8-17 yo Identical Twins (Fluzone)|Participants will be randomized to receive Fluzone® (intramuscular)
11168633|NCT01987349|BG001|Baseline|Group A: Age 8-17 yo Identical Twins (FluMist)|Participants will be randomized to receive FluMist® (intranasal)
11168634|NCT01987349|BG002|Baseline|Group B: Age 18-30 yo Identical Twins|Participants to receive FluMist® (intranasal)
11168635|NCT01987349|BG003|Baseline|Group C: Age 18-30 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
11168636|NCT01987349|BG004|Baseline|Group D: Age 40-49 yo Identical Twins|Participants to receive FluMist® (intranasal)
11168637|NCT01987349|BG005|Baseline|Group E: Age 40-49 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
11168638|NCT01987349|BG006|Baseline|Group F: 70-100 yo Identical Twins|Participants to receive Fluzone® (intramuscular)
11168639|NCT01987349|BG007|Baseline|Group G: 70-100 yo Nontwins|Participants to receive Fluzone® (intramuscular)
11168640|NCT01987349|BG008|Baseline|Total|Total of all reporting groups
11168641|NCT01987349|FG000|Participant Flow|Group A: Age 8-17 yo Identical Twins|Participants will be randomized to receive Fluzone® (intramuscular)
11168642|NCT01987349|FG001|Participant Flow|Group A: Age 8-17yo Identical Twins|Participants will be randomized to receive FluMist® (intranasal)
11168643|NCT01987349|FG002|Participant Flow|Group B: Age 18-30 yo Identical Twins|Participants to receive FluMist® (intranasal)
11168644|NCT01987349|FG003|Participant Flow|Group C: Age 18-30 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
11168645|NCT01987349|FG004|Participant Flow|Group D: Age 40-49 yo Identical Twins|Participants to receive FluMist® (intranasal)
11168646|NCT01987349|FG005|Participant Flow|Group E: Age 40-49 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
11168647|NCT01987349|FG006|Participant Flow|Group F: 70-100 yo Identical Twins|Participants to receive Fluzone® (intramuscular)
11168648|NCT01987349|FG007|Participant Flow|Group G: 70-100 yo Nontwins|Participants to receive Fluzone® (intramuscular)
11168649|NCT01987349|OG000|Outcome|Group A: Age 8-17 yo Identical Twins (IM)|"Participants will be randomized to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
11168650|NCT01987349|OG001|Outcome|Group A: Age 8-17 yo Identical Twins (IN)|"Participants will be randomized to receive FluMist® (intranasal~FluMist®: Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11168651|NCT01987349|OG002|Outcome|Group B: 18-30 yo Identical Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11168652|NCT01987349|OG003|Outcome|Group C: 18-30 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11168653|NCT01987349|OG004|Outcome|Group D: 40-49 yo Identical Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11168654|NCT01987349|OG005|Outcome|Group E: 40-49 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11168655|NCT01987349|OG006|Outcome|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
11168656|NCT01987349|OG007|Outcome|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
11168657|NCT01987349|OG001|Outcome|Group A: Age 8-17 yo Identical Twins (IN)|"Participants will be randomized to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11168658|NCT01987349|OG003|Outcome|Group C: 18-30 yo Fraternal Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11354630|NCT03848455|BG000|Baseline|Parkinson's Disease Group|"Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;~Newly diagnosed primary PD patients, diagnosed within 3-6 months;~informed consent to the study;~age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD ,PPS patients and healthy controls."
11354631|NCT03848455|BG001|Baseline|Healthy Controls|"healthy group inclusion criteria: age, gender-matched PD group, non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history; informed consent to the study; age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls ."
11354632|NCT03848455|BG002|Baseline|Parkinson-plus Syndrome Group|"1. patients with Parkinson-plus syndrome were diagnosed according to 2017 MDS progressive supranuclear paralysis and 2017 clinical diagnostic criteria for MDS progressive supra palsy (PSP patients) and Giman standard, the 2008 American board of neurology (AAN) MSA diagnostic consensus.2.informed consent to the study; 3.age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls ."
11354633|NCT03848455|BG003|Baseline|Total|Total of all reporting groups
11354634|NCT03848455|FG000|Participant Flow|Parkinson's Disease Group|"Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;~Newly diagnosed primary PD patients, diagnosed within 3-6 months;~informed consent to the study;~age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD ,PPS patients and healthy controls."
11354635|NCT03848455|FG001|Participant Flow|Healthy Controls|"healthy group inclusion criteria: age, gender-matched PD group, non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history; informed consent to the study; age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls ."
11354636|NCT03848455|FG002|Participant Flow|Parkinson-plus Syndrome Group|"1. patients with Parkinson-plus syndrome were diagnosed according to 2017 MDS progressive supranuclear paralysis and 2017 clinical diagnostic criteria for MDS progressive supra palsy (PSP patients) and Giman standard, the 2008 American board of neurology (AAN) MSA diagnostic consensus.2.informed consent to the study; 3.age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls ."
11354637|NCT03848455|OG000|Outcome|Parkinson's Disease Group|"Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;~Newly diagnosed primary PD patients, diagnosed within 3-6 months;~informed consent to the study;~age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD ,PPS patients and healthy controls."
11168659|NCT01987349|OG004|Outcome|Group D: 40-49 yo Identical Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11354638|NCT03848455|OG001|Outcome|Healthy Controls|"healthy group inclusion criteria: age, gender-matched PD group, non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history; informed consent to the study; age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls ."
11354639|NCT03848455|OG002|Outcome|Parkinson-plus Syndrome Group|"1. patients with Parkinson-plus syndrome were diagnosed according to 2017 MDS progressive supranuclear paralysis and 2017 clinical diagnostic criteria for MDS progressive supra palsy (PSP patients) and Giman standard, the 2008 American board of neurology (AAN) MSA diagnostic consensus.2.informed consent to the study; 3.age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls ."
11354640|NCT03848455|OG000|Outcome|Parkinson's Disease Group|"Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;~Newly diagnosed primary PD patients, diagnosed within 3-6 months;~informed consent to the study;~age > 18 older.~genetic diagnosis: The venous blood of the two groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and non-PD patients."
11357320|NCT03760913|FG010|Participant Flow|80 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg
11168660|NCT01987349|OG005|Outcome|Group E: 40-49 yo Fraternal Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11168661|NCT01987349|EG000|Reported Event|Group A: Age 8-17 yo Identical Twins (Fluzone)|Participants will be randomized to receive Fluzone® (intramuscular)
11168662|NCT01987349|EG001|Reported Event|Group A: Age 8-17 yo Identical Twins (Flumist)|Participants will be randomized to receive Flumist® (intranasal)
11354641|NCT03848455|EG000|Reported Event|Parkinson's Disease Group|"Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria;~Newly diagnosed primary PD patients, diagnosed within 3-6 months;~informed consent to the study;~age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD ,PPS patients and healthy controls."
11354642|NCT03848455|EG001|Reported Event|Healthy Controls|"healthy group inclusion criteria: age, gender-matched PD group, non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history; informed consent to the study; age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls ."
11354643|NCT03848455|EG002|Reported Event|Parkinson-plus Syndrome Group|"1. patients with Parkinson-plus syndrome were diagnosed according to 2017 MDS progressive supranuclear paralysis and 2017 clinical diagnostic criteria for MDS progressive supra palsy (PSP patients) and Giman standard, the 2008 American board of neurology (AAN) MSA diagnostic consensus.2.informed consent to the study; 3.age > 18 older.~genetic diagnosis: The venous blood of the three groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and PPS patients and healthy controls ."
11354644|NCT03858894|BG000|Baseline|Test Arm: DE-117 BID|"DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)~DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye"
11354645|NCT03858894|BG001|Baseline|Drug Arm: DE-117 QD|"DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD~DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye"
11354646|NCT03858894|BG002|Baseline|Total|Total of all reporting groups
11354647|NCT03858894|FG000|Participant Flow|Test Arm: DE-117 BID|"DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)~DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye"
11354648|NCT03858894|FG001|Participant Flow|Drug Arm: DE-117 QD|"DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD~DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye"
11354649|NCT03858894|OG000|Outcome|Test Arm: DE-117 BID|"DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)~DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye"
11354650|NCT03858894|OG001|Outcome|Drug Arm: DE-117 QD|"DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD~DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye"
11354651|NCT03858894|EG000|Reported Event|Test Arm: DE-117 BID|"DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)~DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye"
11354652|NCT03858894|EG001|Reported Event|Drug Arm: DE-117 QD|"DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD~DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye"
11354653|NCT03856164|BG000|Baseline|Tranexamic Acid|"Tranexamic Acid for intravenous administration.~Tranexamic Acid: Two doses of Tranexamic Acid (1 gram), diluted in 100 cc of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery."
11354654|NCT03856164|BG001|Baseline|Placebo|"Normal saline for intravenous administration.~Placebo: 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery."
11354655|NCT03856164|BG002|Baseline|Total|Total of all reporting groups
11354656|NCT03856164|FG000|Participant Flow|Tranexamic Acid|Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
11354657|NCT03856164|FG001|Participant Flow|Placebo|Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
11354658|NCT03856164|OG000|Outcome|Tranexamic Acid|Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
11354659|NCT03856164|OG001|Outcome|Placebo|Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
11354660|NCT03856164|OG000|Outcome|Tranexamic Acid|"Tranexamic Acid for intravenous administration.~Tranexamic Acid: Two doses of Tranexamic Acid (1 gram), diluted in 100 cc of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery."
11354661|NCT03856164|OG001|Outcome|Placebo|"Normal saline for intravenous administration.~Placebo: 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery."
11354662|NCT03856164|EG000|Reported Event|Tranexamic Acid|Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
11354663|NCT03856164|EG001|Reported Event|Placebo|Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
11354664|NCT03850275|BG000|Baseline|Placebo, Then Caffeinated Placebo, Then e+Shots|Participants received the placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the caffeinated placebo and tested for 108 minutes. After another 48 hour washout period they received the e+shot and were tested for 108 minutes
11357321|NCT03760913|FG011|Participant Flow|160 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg
11354665|NCT03850275|BG001|Baseline|Placebo, Then e+Shots, the Caffeinated Placebo|Participants received the placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the e+shots and tested for 108 minutes. After another 48 hour washout period they received the caffeinated placebo and were tested for 108 minutes
11354666|NCT03850275|BG002|Baseline|Caffeinated Placebo, Then Placebo, Then e+Shots|Participants received the caffeinated placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the placebo and tested for 108 minutes. After another 48 hour washout period they received the e+shot and were tested for 108 minutes
11354667|NCT03850275|BG003|Baseline|Caffeinated Placebo, Then e+Shots, Then Placebo|Participants received the caffeinated placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the e+shot and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes
11354668|NCT03850275|BG004|Baseline|E+Shots, Then Placebo, Then Caffeinated Placebo|Participants received the e+shot and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the placebo and tested for 108 minutes. After another 48 hour washout period they received the caffeinated placebo and were tested for 108 minutes
11354669|NCT03850275|BG005|Baseline|E+Shot, Then Caffeinated Placebo, Then Placebo|Participants received the e+shot and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the caffeinated placebo and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes
11354670|NCT03850275|BG006|Baseline|Total|Total of all reporting groups
11354671|NCT03850275|FG000|Participant Flow|Placebo, Then Caffeinated Placebo, Then e+Shots|Participants received the placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the caffeinated placebo and tested for 108 minutes. After another 48 hour washout period they received the e+shot and were tested for 108 minutes
11354672|NCT03850275|FG001|Participant Flow|Placebo, Then e+Shots, Then Caffeine|Participants received the placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received e+shots and tested for 108 minutes. After another 48 hour washout period they received the caffeinated placebo and were tested for 108 minutes
11354673|NCT03850275|FG002|Participant Flow|Caffeinated Placebo, Then Placebo, Then e+Shots|Participants received the caffeinated placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the placebo and tested for 108 minutes. After another 48 hour washout period they received the e+shot and were tested for 108 minutes
11354674|NCT03850275|FG003|Participant Flow|Caffeinated Placebo, Then e+Shots, Then Placebo|Participants received the caffeinated placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the e+shots and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes
11354675|NCT03850275|FG004|Participant Flow|e+Shots, Then Placebo, Then Caffeinated Placebo|Participants received the e+shots and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the placebo and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes
11354676|NCT03850275|FG005|Participant Flow|e+Shots, Then Caffeinated Placebo, Then Placebo|Participants received the e+shots and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the caffeinated placebo and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes
11354677|NCT03850275|OG000|Outcome|Placebo|"<3mg of caffeine~Placebo: ~3mg caffeine"
11354678|NCT03850275|OG001|Outcome|Caffeinated Placebo|"~100mg caffeine~Caffeinated placebo: ~100mg of synthetic caffeine"
11354679|NCT03850275|OG002|Outcome|E+Shots|"~100mg caffeine + adaptogens~E+shots: The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis."
11354680|NCT03850275|OG000|Outcome|Placebo|<3mg of caffeine Placebo: ~3mg caffeine
11354681|NCT03850275|OG001|Outcome|E+Shot|~100mg caffeine + adaptogens E+shots: The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.
11354682|NCT03850275|OG002|Outcome|Caffeinated Placebo|~100mg caffeine Caffeinated placebo: ~100mg of synthetic caffeine
11354683|NCT03850275|OG000|Outcome|Placebo Systolic|<3mg of caffeine Placebo: ~3mg caffeine
11354684|NCT03850275|OG001|Outcome|Placebo Diastolic|<3mg of caffeine Placebo: ~3mg caffeine
11354685|NCT03850275|OG002|Outcome|E+Shot Systolic|~100mg caffeine + adaptogens E+shots: The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.
11168663|NCT01987349|EG002|Reported Event|Group B: 18-30 yo Identical Twin Pairs|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11354686|NCT03850275|OG003|Outcome|E+Shot Diastolic|~100mg caffeine + adaptogens E+shots: The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.
11354687|NCT03850275|OG004|Outcome|Caffeinated Placebo Systolic|~100mg caffeine Caffeinated placebo: ~100mg of synthetic caffeine
11354688|NCT03850275|OG005|Outcome|Caffeinated Placebo Diastolic|~100mg caffeine Caffeinated placebo: ~100mg of synthetic caffeine
11354689|NCT03850275|OG000|Outcome|Placebo Non-dominant Hand|<3mg of caffeine Placebo: ~3mg caffeine
11354690|NCT03850275|OG001|Outcome|Placebo Dominant Hand|<3mg of caffeine Placebo: ~3mg caffeine
11354691|NCT03850275|OG002|Outcome|E+Shot Non-dominant Hand|~100mg caffeine + adaptogens E+shots: The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.
11354692|NCT03850275|OG003|Outcome|E+Shot Dominant Hand|~100mg caffeine + adaptogens E+shots: The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.
11354693|NCT03850275|OG004|Outcome|Caffeinated Placebo Non-Dominant Hand|~100mg caffeine Caffeinated placebo: ~100mg of synthetic caffeine
11354694|NCT03850275|OG005|Outcome|Caffeinated Placebo Dominant Hand|~100mg caffeine Caffeinated placebo: ~100mg of synthetic caffeine
11354695|NCT03850275|EG000|Reported Event|Placebo|"<3mg of caffeine~Placebo: ~3mg caffeine"
11354696|NCT03850275|EG001|Reported Event|Caffeinated Placebo|"~100mg caffeine~Caffeinated placebo: ~100mg of synthetic caffeine"
11354697|NCT03850275|EG002|Reported Event|E+Shots|"~100mg caffeine + adaptogens~E+shots: The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis."
11354698|NCT03851016|BG000|Baseline|Life Story Book Intervention First, Then Usual Care|Participants first received the Life Story Book Intervention for one hour a week for three weeks. After a washout period of 1 week, they then received three weeks of usual care.
11354699|NCT03851016|BG001|Baseline|Usual Care First, Then Life Story Book Intervention|Participants received three weeks of usual care first. After a washout period of 1 week, they then received three weeks of the Life Story Book Intervention
11354700|NCT03851016|BG002|Baseline|Total|Total of all reporting groups
11354701|NCT03851016|FG000|Participant Flow|Life Story Book Intervention First, Then Usual Care|Participants first received the Life Story Book Intervention for one hour each week for 3 weeks. After a washout period of 1 week and measures collected (Time 2), they then received the Usual Care intervention for 3 weeks. Posttests (Time 3) were conducted the week after the Usual Care intervention.
11354702|NCT03851016|FG001|Participant Flow|Usual Care First, Then Life Story Book Intervention|Participants first received the Usual Care Intervention for 3 weeks. After a washout period of 1 week and measures collected (Time 2), they then received the Life Story Book Intervention for one hour a week for 3 weeks. Posttests (Time 3) were conducted the week after the Life Story Book Intervention.
11354703|NCT03851016|OG000|Outcome|Life Story Book Intervention|Participants who received the Life Story Book intervention in either the first three weeks or the last three weeks of the study.
11354704|NCT03851016|OG001|Outcome|Usual Care|Participants who received Usual Care in either the first or last 3 weeks of the study.
11354705|NCT03851016|EG000|Reported Event|Life Story Book Intervention|Two comparable nursing homes (NH) were allocated to either Life Story Book Intervention first (NH-A) or Usual Care first (NH-B) Participants in the same NH will receive the same intervention.
11354706|NCT03851016|EG001|Reported Event|Usual Care Intervention|Two comparable nursing homes (NH) were randomly allocated to either Life Story Book Intervention first (NH-A) or Usual Care first (NH-B) Participants in the same NH will receive the same intervention.
11354707|NCT03850496|BG000|Baseline|Group A|No device utilised for 6 weeks.
11354708|NCT03850496|BG001|Baseline|Group B|"Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.~Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence."
11354709|NCT03850496|BG002|Baseline|Group C|"Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.~Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence."
11354710|NCT03850496|BG003|Baseline|Total|Total of all reporting groups
11354711|NCT03850496|FG000|Participant Flow|Group A|No device utilised for 6 weeks.
11354712|NCT03850496|FG001|Participant Flow|Group B|"Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.~Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence."
11354713|NCT03850496|FG002|Participant Flow|Group C|"Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.~Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence."
11354714|NCT03850496|OG000|Outcome|Group A|No device utilised for 6 weeks.
11354715|NCT03850496|OG001|Outcome|Group B|"Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.~Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence."
11354716|NCT03850496|OG002|Outcome|Group C|"Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.~Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence."
11354717|NCT03850496|EG000|Reported Event|Group A|No device utilised for 6 weeks.
11354718|NCT03850496|EG001|Reported Event|Group B|"Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.~Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence."
11354719|NCT03850496|EG002|Reported Event|Group C|"Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.~Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence."
11354720|NCT03848949|BG000|Baseline|Intervention|Patients who received the orthotic device.
11354721|NCT03848949|BG001|Baseline|Control|Patients who did not receive the orthotic device.
11354722|NCT03848949|BG002|Baseline|Total|Total of all reporting groups
11354723|NCT03848949|FG000|Participant Flow|Intervention Group|Patients who received the orthotic device
11354724|NCT03848949|FG001|Participant Flow|Control Group|Patients who did not receive the orthotic device.
11354725|NCT03848949|OG000|Outcome|Orthotic Group|"Subjects enrolled in the orthotic group receive the orthotic (Evenup) meant to increase the effective leg length of the uninjured limb.~Evenup: Orthotic which increases effective leg length."
11354726|NCT03848949|OG001|Outcome|Control|Subjects enrolled in the control group receive the standard treatment associated with their injury (no orthotic)
11354727|NCT03848949|EG000|Reported Event|Orthotic Group|"Subjects enrolled in the orthotic group receive the orthotic (Evenup) meant to increase the effective leg length of the uninjured limb.~Evenup: Orthotic which increases effective leg length."
11354728|NCT03848949|EG001|Reported Event|Control|Subjects enrolled in the control group receive the standard treatment associated with their injury (no orthotic)
11357322|NCT03760913|FG012|Participant Flow|5 x Placebo Part B, Multiple Ascending Dose|Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5
11357323|NCT03760913|FG013|Participant Flow|5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg
11357324|NCT03760913|FG014|Participant Flow|5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg
11357325|NCT03760913|FG015|Participant Flow|5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg
11168664|NCT01987349|EG003|Reported Event|Group C: 18-30 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11357326|NCT03760913|FG016|Participant Flow|5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg
11357327|NCT03760913|FG017|Participant Flow|5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg
11168665|NCT01987349|EG004|Reported Event|Group D: 40-49 yo Identical Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11357328|NCT03760913|FG018|Participant Flow|5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
11357329|NCT03760913|OG000|Outcome|Placebo Part A, Single Ascending Dose|Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo
11357330|NCT03760913|OG001|Outcome|30 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng
11357331|NCT03760913|OG002|Outcome|120 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng
11357332|NCT03760913|OG003|Outcome|400 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng
11357333|NCT03760913|OG004|Outcome|1.2 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg
11357334|NCT03760913|OG005|Outcome|3 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg
11357335|NCT03760913|OG006|Outcome|6 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg
11357336|NCT03760913|OG007|Outcome|12 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg
11357337|NCT03760913|OG008|Outcome|20 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg
11357338|NCT03760913|OG009|Outcome|40 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg
11357339|NCT03760913|OG010|Outcome|80 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg
11357340|NCT03760913|OG011|Outcome|160 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg
11357341|NCT03760913|OG012|Outcome|5 x Placebo Part B, Multiple Ascending Dose|Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5
11357342|NCT03760913|OG013|Outcome|5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg
11357343|NCT03760913|OG014|Outcome|5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg
11354729|NCT03849690|BG000|Baseline|TAK-906 25 mg + Esomeprazole 40 mg and TAK-906 25 mg|TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 4 days, further followed by esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2.
11354730|NCT03849690|FG000|Participant Flow|TAK-906 25 mg + Esomeprazole 40 mg and TAK-906 25 mg|TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 4 days, further followed by esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2.
11354731|NCT03849690|OG000|Outcome|TAK-906 25 mg|TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
11354732|NCT03849690|OG001|Outcome|Esomeprazole 40 mg and TAK-906 25 mg|Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2.
11354733|NCT03849690|OG001|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 of Study Period 2.
11354734|NCT03849690|OG002|Outcome|Esomeprazole 40 mg and TAK-906 25 mg|Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2.
11354735|NCT03849690|EG000|Reported Event|TAK-906 25 mg|TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
11354736|NCT03849690|EG001|Reported Event|Esomeprazole 40 mg|Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 of Study Period 2.
11354737|NCT03849690|EG002|Reported Event|Esomeprazole 40 mg and TAK-906 25 mg|Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2.
10887962|NCT00503997|EG000|Reported Event|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
10887963|NCT00504023|BG000|Baseline|Imiquimod|This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
10887964|NCT00504023|FG000|Participant Flow|Imiquimod|This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
10887965|NCT00504023|OG000|Outcome|Imiquimod|This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
10887966|NCT00504023|EG000|Reported Event|Imiquimod|This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
10887967|NCT00504075|BG000|Baseline|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
10887968|NCT00504075|FG000|Participant Flow|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
11354738|NCT03845933|BG000|Baseline|Water Exchange (WE) Colonoscopy|"Water exchange will be used during colonoscopy insertion. Upon arriving at the cecum, CO2 will be opened. The scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The scope will be reinserted into the cecum by the first endoscopist. A tandem inspection of right colon will be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.~Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance."
11354739|NCT03845933|BG001|Baseline|CO2 Insufflation Colonoscopy|"The colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then the scope will be reinserted into the cecum by the first endoscopist using CO2. A tandem inspection of the right colon will then be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.~Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance."
11354740|NCT03845933|BG002|Baseline|Total|Total of all reporting groups
11354741|NCT03845933|FG000|Participant Flow|Water Exchange (WE) Colonoscopy|"Water exchange will be used during colonoscopy insertion. Upon arriving at the cecum, CO2 will be opened. The scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The scope will be reinserted into the cecum by the first endoscopist. A tandem inspection of right colon will be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.~Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance."
11357344|NCT03760913|OG015|Outcome|5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg
11357345|NCT03760913|OG016|Outcome|5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg
10887969|NCT00504075|OG000|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
10887970|NCT00504075|OG000|Outcome|GAMMAPLEX|The first course of Gammaplex was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
10887971|NCT00504075|EG000|Reported Event|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
10887972|NCT00504153|BG000|Baseline|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10887973|NCT00504153|FG000|Participant Flow|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10887974|NCT00504153|OG000|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10887975|NCT00504153|EG000|Reported Event|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10887976|NCT00504166|BG000|Baseline|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
10887977|NCT00504166|BG001|Baseline|Placebo|placebo to match alendronate sodium
10887978|NCT00504166|BG002|Baseline|Total|Total of all reporting groups
10887979|NCT00504166|FG000|Participant Flow|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
10887980|NCT00504166|FG001|Participant Flow|Placebo|placebo to match alendronate sodium
10887981|NCT00504166|OG000|Outcome|Alendronate Treatment|70 mg of alendronate once weekly and daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
10887982|NCT00504166|OG001|Outcome|Placebo Treatment|daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
10887983|NCT00504166|EG000|Reported Event|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
10887984|NCT00504166|EG001|Reported Event|Placebo|placebo to match alendronate sodium
10887985|NCT00504231|BG000|Baseline|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
11354742|NCT03845933|FG001|Participant Flow|CO2 Insufflation Colonoscopy|"The colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then the scope will be reinserted into the cecum by the first endoscopist using CO2. A tandem inspection of the right colon will then be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.~Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance."
11354743|NCT03845933|OG000|Outcome|Water Exchange (WE) Colonoscopy|"Water exchange will be used during colonoscopy insertion. Upon arriving at the cecum, CO2 will be opened. The scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The scope will be reinserted into the cecum by the first endoscopist. A tandem inspection of right colon will be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.~Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance."
10887986|NCT00504231|BG001|Baseline|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
10887987|NCT00504231|BG002|Baseline|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
10887988|NCT00504231|BG003|Baseline|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
10887989|NCT00504231|BG004|Baseline|Total|Total of all reporting groups
10887990|NCT00504231|FG000|Participant Flow|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
10887991|NCT00504231|FG001|Participant Flow|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
10887992|NCT00504231|FG002|Participant Flow|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
10887993|NCT00504231|FG003|Participant Flow|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
10887994|NCT00504231|OG000|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
10887995|NCT00504231|OG001|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
10887996|NCT00504231|OG002|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
10887997|NCT00504231|OG003|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
11354744|NCT03845933|OG001|Outcome|CO2 Insufflation Colonoscopy|"The colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then the scope will be reinserted into the cecum by the first endoscopist using CO2. A tandem inspection of the right colon will then be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.~Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance."
11354745|NCT03845933|EG000|Reported Event|Water Exchange (WE) Colonoscopy|"Water exchange will be used during colonoscopy insertion. Upon arriving at the cecum, CO2 will be opened. The scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The scope will be reinserted into the cecum by the first endoscopist. A tandem inspection of right colon will be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.~Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance."
11354746|NCT03845933|EG001|Reported Event|CO2 Insufflation Colonoscopy|"The colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then the scope will be reinserted into the cecum by the first endoscopist using CO2. A tandem inspection of the right colon will then be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.~Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance."
11354747|NCT03844945|BG000|Baseline|Netarsudil Ophthalmic Solution 0.01%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution"
11354748|NCT03844945|BG001|Baseline|Netarsudil Ophthalmic Solution 0.02%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution"
11354749|NCT03844945|BG002|Baseline|Netarsudil Ophthalmic Solution 0.04%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution"
11354750|NCT03844945|BG003|Baseline|Netarsudil Ophthalmic Solution Placebo|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution Placebo: Topical sterile ophthalmic solution"
11354751|NCT03844945|BG004|Baseline|Total|Total of all reporting groups
11354752|NCT03844945|FG000|Participant Flow|Netarsudil Ophthalmic Solution 0.01%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution"
11354753|NCT03844945|FG001|Participant Flow|Netarsudil Ophthalmic Solution 0.02%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution"
11354754|NCT03844945|FG002|Participant Flow|Netarsudil Ophthalmic Solution 0.04%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution"
11354755|NCT03844945|FG003|Participant Flow|Netarsudil Ophthalmic Solution Placebo|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution Placebo: Topical sterile ophthalmic solution"
11354756|NCT03844945|OG000|Outcome|Netarsudil Ophthalmic Solution 0.01%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution"
11354757|NCT03844945|OG001|Outcome|Netarsudil Ophthalmic Solution 0.02%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution"
11354758|NCT03844945|OG002|Outcome|Netarsudil Ophthalmic Solution 0.04%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution"
11354759|NCT03844945|OG003|Outcome|Netarsudil Ophthalmic Solution Placebo|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution Placebo: Topical sterile ophthalmic solution"
11354760|NCT03844945|EG000|Reported Event|Netarsudil Ophthalmic Solution 0.01%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution"
11354761|NCT03844945|EG001|Reported Event|Netarsudil Ophthalmic Solution 0.02%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution"
11354762|NCT03844945|EG002|Reported Event|Netarsudil Ophthalmic Solution 0.04%|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution"
11354763|NCT03844945|EG003|Reported Event|Netarsudil Ophthalmic Solution Placebo|"1 drop daily into each eye in the evening for 28 days~Netarsudil Ophthalmic Solution Placebo: Topical sterile ophthalmic solution"
11354764|NCT03844321|BG000|Baseline|Mindfulness-Based Cognitive Therapy|"8 sessions of online mindfulness-based cognitive therapy~Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy"
11354765|NCT03844321|BG001|Baseline|Brief Mindfulness|"3 sessions of online mindfulness therapy~Brief Mindfulness: 3 sessions of online mindfulness therapy"
11354766|NCT03844321|BG002|Baseline|Total|Total of all reporting groups
11354767|NCT03844321|FG000|Participant Flow|Mindfulness-Based Cognitive Therapy|"8 sessions of online mindfulness-based cognitive therapy~Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy"
11354768|NCT03844321|FG001|Participant Flow|Brief Mindfulness|"3 sessions of online mindfulness therapy~Brief Mindfulness: 3 sessions of online mindfulness therapy"
11354769|NCT03844321|OG000|Outcome|Mindfulness-Based Cognitive Therapy|"8 sessions of online mindfulness-based cognitive therapy~Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy"
11354770|NCT03844321|OG001|Outcome|Brief Mindfulness|"3 sessions of online mindfulness therapy~Brief Mindfulness: 3 sessions of online mindfulness therapy"
11354771|NCT03844321|EG000|Reported Event|Mindfulness-Based Cognitive Therapy|"8 sessions of online mindfulness-based cognitive therapy~Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy"
11354772|NCT03844321|EG001|Reported Event|Brief Mindfulness|"3 sessions of online mindfulness therapy~Brief Mindfulness: 3 sessions of online mindfulness therapy"
11354773|NCT03843632|BG000|Baseline|VARIVAX Adults (18 to 75 Years)|Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
11354774|NCT03843632|BG001|Baseline|VARIVAX™ Adolescents 13 to 17 Years of Age|Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
11354775|NCT03843632|BG002|Baseline|VARIVAX™ Children 7 to 12 Years of Age|Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
11354776|NCT03843632|BG003|Baseline|VARIVAX™ Children 12 Months to 6 Years of Age|Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
11354777|NCT03843632|BG004|Baseline|Total|Total of all reporting groups
11354778|NCT03843632|FG000|Participant Flow|VARIVAX Adults (18 to 75 Years)|Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
11354779|NCT03843632|FG001|Participant Flow|VARIVAX™ Adolescents 13 to 17 Years of Age|Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
11354780|NCT03843632|FG002|Participant Flow|VARIVAX™ Children 7 to 12 Years of Age|Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
11354781|NCT03843632|FG003|Participant Flow|VARIVAX™ Children 12 Months to 6 Years of Age|Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
11354782|NCT03843632|OG000|Outcome|VARIVAX Adults (18 to 75 Years)|Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
11354783|NCT03843632|OG001|Outcome|VARIVAX™ Adolescents 13 to 17 Years of Age|Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
11354784|NCT03843632|OG002|Outcome|VARIVAX™ Children 7 to 12 Years of Age|Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
11354785|NCT03843632|OG003|Outcome|VARIVAX™ Children 12 Months to 6 Years of Age|Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
11354786|NCT03843632|EG000|Reported Event|VARIVAX Adults (18 to 75 Years)|Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
11354787|NCT03843632|EG001|Reported Event|VARIVAX Adolescents (13 to 17 Years)|Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
11354788|NCT03843632|EG002|Reported Event|VARIVAX Children (7 to 12 Years)|Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
11354789|NCT03843632|EG003|Reported Event|VARIVAX Children (12 Months to 6 Years)|Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
11354790|NCT03840811|BG000|Baseline|Mutant FA7537|Participants received a bacterial inoculum containing only the isogenic MtrD mutant N. gonorrhoeae strain.
11354791|NCT03840811|BG001|Baseline|Wild-type FA1090|Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
11354792|NCT03840811|BG002|Baseline|Mixed FA1090/FA7537|Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
11354793|NCT03840811|BG003|Baseline|Total|Total of all reporting groups
11354794|NCT03840811|FG000|Participant Flow|Mutant FA7537|"Participants received a bacterial inoculum containing only the isogenic mtrD mutant N. gonorrhoeae strain.~Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.~Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.~Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.~Neisseria gonorrhoeae strain FA7537: 0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter."
11354795|NCT03840811|FG001|Participant Flow|Wild-type FA1090|"Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.~Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.~Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.~Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.~Neisseria gonorrhoeae strain FA1090 A26: 0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter."
11354796|NCT03840811|FG002|Participant Flow|Mixed FA1090/FA7537|"Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.~Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.~Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.~Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.~Neisseria gonorrhoeae strain FA1090 A26: 0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.~Neisseria gonorrhoeae strain FA7537: 0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter."
11354797|NCT03840811|OG000|Outcome|Mixed FA1090/FA7537|Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
11354798|NCT03840811|OG000|Outcome|Mutant FA7537|Participants received a bacterial inoculum containing only the isogenic MtrD mutant N. gonorrhoeae strain.
11354799|NCT03840811|OG001|Outcome|Wild-type FA1090|Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
11354800|NCT03840811|EG000|Reported Event|Mutant FA7537|Participants received a bacterial inoculum containing only the isogenic MtrD mutant N. gonorrhoeae strain.
11354801|NCT03840811|EG001|Reported Event|Wild-type FA1090|Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
11354802|NCT03840811|EG002|Reported Event|Mixed FA1090/FA7537|Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
11354803|NCT03837028|BG000|Baseline|HPV 16/18 (+), Cytology Normal|"Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.~The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11089730|NCT01524991|OG000|Outcome|Treatment|"Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)~Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)~Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)~Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)"
11168666|NCT01987349|EG005|Reported Event|Group E: 40-49 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
11354804|NCT03837028|BG001|Baseline|HPV 16/18 (+), Cytology Abnormal|"Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354805|NCT03837028|BG002|Baseline|Non-16/18 HPV (+), Cytology Abnormal|"Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11357346|NCT03760913|OG017|Outcome|5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg
11357347|NCT03760913|OG018|Outcome|5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
11357348|NCT03760913|OG000|Outcome|12 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg
11354806|NCT03837028|BG003|Baseline|Non-16/18 HPV (+), Cytology Normal|"Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354807|NCT03837028|BG004|Baseline|Total|Total of all reporting groups
11354808|NCT03837028|FG000|Participant Flow|Human Papillomavirus (HPV) 16/18 (+), Cytology Normal|"Women who have Human papillomavirus (HPV) (16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.~The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354809|NCT03837028|FG001|Participant Flow|Human Papillomavirus (HPV)16/18 (+), Cytology Abnormal|"Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354810|NCT03837028|FG002|Participant Flow|Non-16/18 Human Papillomavirus (HPV) (+), Cytology Abnormal|"Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354811|NCT03837028|FG003|Participant Flow|Non-16/18 Human Papillomavirus (HPV) (+), Cytology Normal|"Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354812|NCT03837028|OG000|Outcome|HPV 16/18 (+), Cytology Normal|"Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.~The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354813|NCT03837028|OG001|Outcome|HPV 16/18 (+), Cytology Abnormal|"Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354814|NCT03837028|OG002|Outcome|Non-16/18 HPV (+), Cytology Abnormal|"Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354815|NCT03837028|OG003|Outcome|Non-16/18 HPV (+), Cytology Normal|"Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11232257|NCT02417376|EG000|Reported Event|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
11232258|NCT02417376|EG001|Reported Event|Control|No periodontal intervention in any form.
11232259|NCT02417441|BG000|Baseline|Early Embryo Viability Assessment + Morphological Grading|Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer.
11232260|NCT02417441|BG001|Baseline|Morphological Grading|Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer.
11232261|NCT02417441|BG002|Baseline|Total|Total of all reporting groups
11232262|NCT02417441|FG000|Participant Flow|Early Embryo Viability Assessment + Morphological Grading|Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer.
11232263|NCT02417441|FG001|Participant Flow|Morphological Grading|Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer.
11232264|NCT02417441|OG000|Outcome|Early Embryo Viability Assessment + Morphological Grading|Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer.
11232265|NCT02417441|OG001|Outcome|Morphological Grading|Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer.
11232266|NCT02417441|OG000|Outcome|All Subjects (FHB Positive IR)|"All subjects with positive fetal heart beat (FHB) implantation rate (IR) from Early Embryo Viability Assessment + Morphological Grading and Morphological Grading arm were randomized in this group."
11232267|NCT02417441|EG000|Reported Event|Early Embryo Viability Assessment + Morphological Grading|Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer.
11232268|NCT02417441|EG001|Reported Event|Morphological Grading|Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer.
11232269|NCT02417532|BG000|Baseline|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
11232270|NCT02417532|FG000|Participant Flow|Rex Rehabilitation Patients|Tetraplegic and paraplegic patients able to use REX.
11232271|NCT02417532|OG000|Outcome|Rehabilitation Using REX|Tetraplegic and paraplegic patients
11232272|NCT02417532|OG000|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
11232273|NCT02417532|OG000|Outcome|Rehabilitation Using REX|Tetraplegic and paraplegic patients who could control REX
11232274|NCT02417532|EG000|Reported Event|Rehabilitation Using REX|All patients who were able to transfer into a Rex with or without assistance.
11232275|NCT02417753|BG000|Baseline|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
11232276|NCT02417753|FG000|Participant Flow|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
11232277|NCT02417753|OG000|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
11232278|NCT02417753|EG000|Reported Event|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
11232279|NCT02417831|BG000|Baseline|All Subjects|"Subjects each received two treatments which were each administered orally in the fasted state after an overnight fast of at least 10 hours. and separated by a washout period of 7 days. The treatments were:~New MR (Test): Tamsulosin 0.4mg modified release (MR) capsule.~Registered MR (Reference) : Tamsulosin 0.4mg capsule."
11232280|NCT02417831|FG000|Participant Flow|New MR (Test) / Registered MR (Reference)|Oral administration of tamsulosin new 0.4mg modified release (MR) capsule followed by oral administration of tamsulosin registered 0.4mg MR capsule in the fasted state after an overnight fast of at least 10 hours. Treatment periods were separated by a wash-out period of 07 days.
11232281|NCT02417831|FG001|Participant Flow|Registered MR (Reference) / New MR (Test)|Oral administration of tamsulosin registered 0.4mg MR capsule followed by oral administration of tamsulosin new 0.4mg MR capsule in the fasted state after an overnight fast of at least 10 hours. Treatment periods were separated by a wash-out period of 07 days.
11232282|NCT02417831|OG000|Outcome|New MR (Test)|Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
11232283|NCT02417831|OG001|Outcome|Registered MR (Reference)|Oral administration of tamsulosin registered 0.4mg MR capsule.
11232284|NCT02417831|EG000|Reported Event|New MR (Test)|Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
11232285|NCT02417831|EG001|Reported Event|Registered MR (Reference)|Oral administration of tamsulosin registered 0.4mg MR capsule.
11232286|NCT02417844|BG000|Baseline|All Subjects|"Subjects each received two treatments which were each administered orally and separated by a washout period of 7 days. The treatments were:~Flomax Relief (Reference): Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules).~Tamsulosin hydrochloride (HCl) (Test): Tamsulosin HCl 0.4mg modified release (MR) capsule."
11232287|NCT02417844|FG000|Participant Flow|Tamsulosin HCl (Test) / Flomax Relief (Reference)|Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule followed by oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules).
11232288|NCT02417844|FG001|Participant Flow|Flomax Relief (Reference) / Tamsulosin HCl (Test)|Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules) followed by oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.
11232289|NCT02417844|OG000|Outcome|Tamsulosin HCl (Test)|Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.
11232290|NCT02417844|OG001|Outcome|Flomax Relief (Reference)|Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsule).
11232291|NCT02417844|EG000|Reported Event|Tamsulosin HCl (Test)|Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.
11232292|NCT02417844|EG001|Reported Event|Flomax Relief (Reference)|Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules).
11232293|NCT02417935|BG000|Baseline|Pregabalin|"Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine placebo during treatment period.~Participants who received higher doses of Pregabalin in treatment period received gradually the lower doses of Pregabalin along with Duloxetine placebo during tapering period."
11232294|NCT02417935|BG001|Baseline|Duloxetine|"Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo during treatment period.~Participants who received higher doses of Duloxetine in treatment period received gradually the lower doses of Duloxetine along with Pregabalin placebo during tapering period."
11232295|NCT02417935|BG002|Baseline|Total|Total of all reporting groups
11232296|NCT02417935|FG000|Participant Flow|Pregabalin|"Participants received flexible doses of 150 to 600 mg pregabalin orally twice a day (BID) along with Duloxetine placebo during treatment period.~Participants who received higher doses of Pregabalin in treatment period received gradually the lower doses of Pregabalin along with Duloxetine placebo during tapering period."
11232297|NCT02417935|FG001|Participant Flow|Duloxetine|"Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo during treatment period.~Participants who received higher doses of Duloxetine in treatment period received gradually the lower doses of Duloxetine along with Pregabalin placebo during tapering period."
11232298|NCT02417935|OG000|Outcome|Pregabalin|Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
11232299|NCT02417935|OG001|Outcome|Duloxetine|Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
11232300|NCT02417935|EG000|Reported Event|Pregabalin|Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
11232301|NCT02417935|EG001|Reported Event|Duloxetine|Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
11232302|NCT02417961|BG000|Baseline|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
11232303|NCT02417961|FG000|Participant Flow|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
11232304|NCT02417961|OG000|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
11232305|NCT02417961|EG000|Reported Event|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
11232306|NCT02418000|BG000|Baseline|Cohort 1: E6201 240 mg/m^2 Weekly|Cohort 1: Participants were administered E6201 240 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinued, and followed for up to 6 months after the last dose.
11232307|NCT02418000|BG001|Baseline|Cohort 2: E6201 320 mg/m^2 Weekly|Cohort 2: Participants were administered E6201 320 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
11232308|NCT02418000|BG002|Baseline|Cohort 3: E6201 160 mg/m^2 Twice Weekly|Cohort 3: Participants were administered E6201 160 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
11232309|NCT02418000|BG003|Baseline|Cohort 4: E6201 240 mg/m^2 Twice Weekly|Cohort 4: Participants were administered E6201 240 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
11232310|NCT02418000|BG004|Baseline|Cohort 5: E6201 320 mg/m^2 Twice Weekly|Cohort 5: Participants were administered E6201 320 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
11232311|NCT02418000|BG005|Baseline|Total|Total of all reporting groups
11232312|NCT02418000|FG000|Participant Flow|E6201 240 mg/m^2 Weekly|Cohort 1: Participants were administered E6201 240 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232313|NCT02418000|FG001|Participant Flow|E6201 320 mg/m^2 Weekly|Cohort 2: Participants were administered E6201 320 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232314|NCT02418000|FG002|Participant Flow|E6201 160 mg/m^2 Twice Weekly|Cohort 3: Participants were administered E6201 160 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11357349|NCT03760913|OG001|Outcome|20 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg
11232315|NCT02418000|FG003|Participant Flow|E6201 240 mg/m^2 Twice Weekly|Cohort 4: Participants were administered E6201 240 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232316|NCT02418000|FG004|Participant Flow|E6201 320 mg/m^2 Twice Weekly|Cohort 5: Participants were administered E6201 320 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232317|NCT02418000|OG000|Outcome|All Participants|All study participants who received at least 1 dose of E6201 at 240 or 320 mg/m^2 IV weekly, or at 160, 240 or 320 mg/m^2 IV twice weekly
11232318|NCT02418000|OG000|Outcome|E6201 240 mg/m^2 Weekly|E6201 240 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232319|NCT02418000|OG001|Outcome|E6201 320 mg/m^2 Weekly|E6201 320 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232320|NCT02418000|OG002|Outcome|E6201 160 mg/m^2 Twice Weekly|E6201 160 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232321|NCT02418000|OG003|Outcome|E6201 240 mg/m^2 Twice Weekly|E6201 240 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232322|NCT02418000|OG004|Outcome|E6201 320 mg/m^2 IV Twice Weekly|E6201 320 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232323|NCT02418000|OG004|Outcome|E6201 320 mg/m^2 Twice Weekly|E6201 320 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232324|NCT02418000|OG000|Outcome|E6201 240 mg/m^2 Weekly|E6201 240 mg/m^2 administered IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232325|NCT02418000|OG001|Outcome|E6201 320 mg/m^2 Weekly|E6201 320 mg/m^2 administered IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232326|NCT02418000|OG002|Outcome|E6201 160 mg/m^2 Twice Weekly|E6201 160 mg/m^2 administered IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232327|NCT02418000|OG003|Outcome|E6201 240 mg/m^2 Twice Weekly|E6201 240 mg/m^2 administered IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232328|NCT02418000|OG004|Outcome|E6201 320 mg/m^2 Twice Weekly|E6201 320 mg/m^2 administered IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22, and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232329|NCT02418000|OG000|Outcome|E6201 240 mg/m^2 Weekly|Cohort 1: Participants were administered E6201 240 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232330|NCT02418000|OG001|Outcome|E6201 320 mg/m^2 Weekly|Cohort 2: Participants were administered E6201 320 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232331|NCT02418000|OG002|Outcome|E6201 160 mg/m^2 Twice Weekly|Cohort 3: Participants were administered E6201 160 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232332|NCT02418000|OG003|Outcome|E6201 240 mg/m^2 Twice Weekly|Cohort 4: Participants were administered E6201 240 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232333|NCT02418000|OG004|Outcome|E6201 320 mg/m^2 Twice Weekly|Cohort 5: Participants were administered E6201 320 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232334|NCT02418000|EG000|Reported Event|E6201 240 mg/m^2 Weekly|E6201 240 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232335|NCT02418000|EG001|Reported Event|E6201 320 mg/m^2 Weekly|E6201 320 mg/m^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11357350|NCT03760913|OG002|Outcome|40 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg
11232336|NCT02418000|EG002|Reported Event|E6201 160 mg/m^2 Twice Weekly|E6201 160 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232337|NCT02418000|EG003|Reported Event|E6201 240 mg/m^2 Twice Weekly|E6201 240 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232338|NCT02418000|EG004|Reported Event|E6201 320 mg/m^2 Twice Weekly|E6201 320 mg/m^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
11232339|NCT02418026|BG000|Baseline|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
11232340|NCT02418026|BG001|Baseline|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
11232341|NCT02418026|BG002|Baseline|Total|Total of all reporting groups
11232342|NCT02418026|FG000|Participant Flow|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
11232343|NCT02418026|FG001|Participant Flow|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
11232344|NCT02418026|OG000|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
11232345|NCT02418026|OG001|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
11232346|NCT02418026|EG000|Reported Event|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
11232347|NCT02418026|EG001|Reported Event|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
11232348|NCT02418156|BG000|Baseline|Single Arm|"Observation of subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.~CorMatrix ECM for Vascular Repair: Standard femoral arterial interventional procedure using CorMatrix ECM for arterial repair.~Device performance and adverse events were collected."
11232349|NCT02418156|FG000|Participant Flow|Single Arm|"Observation of subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.~CorMatrix ECM for Vascular Repair: Standard femoral arterial interventional procedure using CorMatrix ECM for arterial repair."
11232350|NCT02418156|OG000|Outcome|Single Arm|"Observation of subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.~CorMatrix ECM for Vascular Repair: Standard femoral arterial interventional procedure using CorMatrix ECM for arterial repair."
11232351|NCT02418156|EG000|Reported Event|Single Arm|"Observation of subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.~CorMatrix ECM for Vascular Repair: Standard femoral arterial interventional procedure using CorMatrix ECM for arterial repair."
11232352|NCT02418182|BG000|Baseline|Control|"Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.~placebo: subjects randomized to this group will be given placebo tablets"
11232353|NCT02418182|BG001|Baseline|Experimental|"Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.~Acetaminophen: Acetaminophen total dose of 1000mg"
11232354|NCT02418182|BG002|Baseline|Total|Total of all reporting groups
11232355|NCT02418182|FG000|Participant Flow|Control|"Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.~placebo: subjects randomized to this group will be given placebo tablets"
11232356|NCT02418182|FG001|Participant Flow|Experimental|"Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.~Acetaminophen: Acetaminophen total dose of 1000mg"
11232357|NCT02418182|OG000|Outcome|Control|"Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.~placebo: subjects randomized to this group will be given placebo tablets"
11232358|NCT02418182|OG001|Outcome|Experimental|"Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.~Acetaminophen: Acetaminophen total dose of 1000mg"
11232359|NCT02418182|EG000|Reported Event|Control|"Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.~placebo: subjects randomized to this group will be given placebo tablets"
11232360|NCT02418182|EG001|Reported Event|Experimental|"Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.~Acetaminophen: Acetaminophen total dose of 1000mg"
11232361|NCT02418234|BG000|Baseline|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment
11232362|NCT02418234|FG000|Participant Flow|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
11232363|NCT02418234|OG000|Outcome|TKI-PD|
11232364|NCT02418234|OG000|Outcome|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
11232365|NCT02418234|OG000|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
11354816|NCT03837028|EG000|Reported Event|HPV 16/18 (+), Cytology Normal|"Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.~The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354817|NCT03837028|EG001|Reported Event|HPV 16/18 (+), Cytology Abnormal|"Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354818|NCT03837028|EG002|Reported Event|Non-16/18 HPV (+), Cytology Abnormal|"Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354819|NCT03837028|EG003|Reported Event|Non-16/18 HPV (+), Cytology Normal|"Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.~FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning."
11354820|NCT03825939|BG000|Baseline|Intravenous Tranexamic Acid|"1g TXA administered intravenous piggyback at start of surgery OR~1g TXA administered intravenous piggyback at start and at time of closure of surgery~Intravenous Tranexamic Acid: 1g TXA IVPB"
11354821|NCT03825939|BG001|Baseline|Intravenous Placebo|"- IV 0.9% sterile saline~Intravenous Placebo: IV 0.9% sterile saline"
11354822|NCT03825939|BG002|Baseline|Intravenous Tranexamic Acid Followed by Intravenous Placebo|"1g TXA administered intravenous piggyback at start of surgery OR~1g TXA administered intravenous piggyback at start and at time of closure of surgery~IV 0.9% sterile saline~Intravenous Placebo: IV 0.9% sterile saline~Intravenous Tranexamic Acid: 1g TXA IVPB"
11354823|NCT03825939|BG003|Baseline|Total|Total of all reporting groups
11354824|NCT03825939|FG000|Participant Flow|Intravenous Tranexamic Acid|"1g TXA administered intravenous piggyback at start of surgery OR~1g TXA administered intravenous piggyback at start and at time of closure of surgery~Intravenous Tranexamic Acid: 1g TXA IVPB"
11354825|NCT03825939|FG001|Participant Flow|Intravenous Placebo|"- IV 0.9% sterile saline~Intravenous Placebo: IV 0.9% sterile saline"
11354826|NCT03825939|FG002|Participant Flow|Intravenous Tranexamic Acid Followed by Intravenous Placebo|"1g TXA administered intravenous piggyback at start of surgery OR~1g TXA administered intravenous piggyback at start and at time of closure of surgery~IV 0.9% sterile saline~Intravenous Placebo: IV 0.9% sterile saline~Intravenous Tranexamic Acid: 1g TXA IVPB"
11354827|NCT03825939|OG000|Outcome|Intravenous Tranexamic Acid|"1g TXA administered intravenous piggyback at start of surgery OR~1g TXA administered intravenous piggyback at start and at time of closure of surgery~Intravenous Tranexamic Acid: 1g TXA IVPB"
11354828|NCT03825939|OG001|Outcome|Intravenous Placebo|"- IV 0.9% sterile saline~Intravenous Placebo: IV 0.9% sterile saline"
11354829|NCT03825939|OG002|Outcome|Intravenous Tranexamic Acid Followed by Intravenous Placebo|"1g TXA administered intravenous piggyback at start of surgery OR~1g TXA administered intravenous piggyback at start and at time of closure of surgery~IV 0.9% sterile saline~Intravenous Placebo: IV 0.9% sterile saline~Intravenous Tranexamic Acid: 1g TXA IVPB"
11354830|NCT03825939|EG000|Reported Event|Intravenous Tranexamic Acid|"1g TXA administered intravenous piggyback at start of surgery OR~1g TXA administered intravenous piggyback at start and at time of closure of surgery~Intravenous Tranexamic Acid: 1g TXA IVPB"
11354831|NCT03825939|EG001|Reported Event|Intravenous Placebo|"- IV 0.9% sterile saline~Intravenous Placebo: IV 0.9% sterile saline"
11354832|NCT03825939|EG002|Reported Event|Intravenous Tranexamic Acid Followed by Intravenous Placebo|"1g TXA administered intravenous piggyback at start of surgery OR~1g TXA administered intravenous piggyback at start and at time of closure of surgery~IV 0.9% sterile saline~Intravenous Placebo: IV 0.9% sterile saline~Intravenous Tranexamic Acid: 1g TXA IVPB"
11354833|NCT03817775|BG000|Baseline|Control|The control group underwent coronary angiography without music intervention.
11354834|NCT03817775|BG001|Baseline|Music Therapy|"The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.~Music therapy: The intervention group administered U sequence between 10 minutes prior to the beginning of the procedure until its end."
11354835|NCT03817775|BG002|Baseline|Total|Total of all reporting groups
11354836|NCT03817775|FG000|Participant Flow|Control|The control group underwent coronary angiography without music intervention.
11354837|NCT03817775|FG001|Participant Flow|Music Therapy|"The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.~Music therapy: The intervention group administered U sequence between 10 minutes prior to the beginning of the procedure until its end."
11354838|NCT03817775|OG000|Outcome|Control|The control group underwent coronary angiography without music intervention.
11357351|NCT03760913|OG003|Outcome|80 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg
11168667|NCT01987349|EG006|Reported Event|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
11168668|NCT01987349|EG007|Reported Event|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
11168669|NCT01987401|BG000|Baseline|Mail|Received mail survey
11168670|NCT01987401|BG001|Baseline|Phone|Received phone survey
11168671|NCT01987401|BG002|Baseline|In-Person|Invited to in-person survey
11168672|NCT01987401|BG003|Baseline|Total|Total of all reporting groups
11168673|NCT01987401|FG000|Participant Flow|Mailed Survey|Participants who received the survey by mail.
11168674|NCT01987401|FG001|Participant Flow|Telephone Survey|Participants who received the survey by telephone.
11168675|NCT01987401|FG002|Participant Flow|In-person Survey|Participants who received survey in person.
11168676|NCT01987401|OG000|Outcome|Mailed Survey|Participants who received the survey by mail.
11168677|NCT01987401|OG001|Outcome|Telephone Survey|Participants who received the survey by telephone.
11168678|NCT01987401|OG002|Outcome|In-person Survey|Participants who received survey in person.
11168679|NCT01987401|EG000|Reported Event|Mailed Survey|Participants who received the survey by mail.
11168680|NCT01987401|EG001|Reported Event|Telephone Survey|Participants who received the survey by telephone.
11168681|NCT01987401|EG002|Reported Event|In-person Survey|Participants who received survey in person.
11168682|NCT01987414|BG000|Baseline|Group A|"Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)~occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.~Forearm rotation orthosis: The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension."
11168683|NCT01987414|BG001|Baseline|Group B|"no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)~occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.~No treatment: Participants will maintain their daily routines during the no treatment period."
11168684|NCT01987414|BG002|Baseline|Total|Total of all reporting groups
11168685|NCT01987414|FG000|Participant Flow|Group A|"Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)~occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.~Forearm rotation orthosis: The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension."
11168686|NCT01987414|FG001|Participant Flow|Group B|"no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)~occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.~No treatment: Participants will maintain their daily routines during the no treatment period."
11168687|NCT01987414|OG000|Outcome|Group A|"Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)~occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.~Forearm rotation orthosis: The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension."
11168688|NCT01987414|OG001|Outcome|Group B|"no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)~occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.~No treatment: Participants will maintain their daily routines during the no treatment period."
11168689|NCT01987414|EG000|Reported Event|Group A|"Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)~occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.~Forearm rotation orthosis: The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension."
11168690|NCT01987414|EG001|Reported Event|Group B|"no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)~occupational therapy task-oriented approach: It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.~No treatment: Participants will maintain their daily routines during the no treatment period."
11168691|NCT01987427|BG000|Baseline|Lorcaserin 10 mg BID + Phentermine Placebo BID|Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
11168692|NCT01987427|BG001|Baseline|Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD|Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
11168693|NCT01987427|BG002|Baseline|Lorcaserin 10 mg BID + Phentermine 15 mg BID|Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
11354839|NCT03817775|OG001|Outcome|Music Therapy|"The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.~Music therapy: The intervention group administered U sequence between 10 minutes prior to the beginning of the procedure until its end."
11168694|NCT01987427|BG003|Baseline|Total|Total of all reporting groups
11168695|NCT01987427|FG000|Participant Flow|Lorcaserin 10 mg BID + Phentermine Placebo BID|Participants received lorcaserin 10 milligram (mg) tablet along with phentermine placebo-matching capsule, orally, twice daily (BID) for 12 weeks.
11168696|NCT01987427|FG001|Participant Flow|Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD|Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, once daily (QD), and phentermine placebo-matching capsule, orally, QD for 12 weeks.
11168697|NCT01987427|FG002|Participant Flow|Lorcaserin 10 mg BID + Phentermine 15 mg BID|Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
11168698|NCT01987427|OG000|Outcome|Lorcaserin 10 mg BID + Phentermine Placebo BID|Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
11168699|NCT01987427|OG001|Outcome|Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD|Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
11168700|NCT01987427|OG002|Outcome|Lorcaserin 10 mg BID + Phentermine 15 mg BID|Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
11168701|NCT01987427|EG000|Reported Event|Lorcaserin 10 mg BID + Phentermine Placebo BID|Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
11168702|NCT01987427|EG001|Reported Event|Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD|Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
11168703|NCT01987427|EG002|Reported Event|Lorcaserin 10 mg BID + Phentermine 15 mg BID|Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
11168704|NCT01987453|BG000|Baseline|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11168705|NCT01987453|BG001|Baseline|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
11168706|NCT01987453|BG002|Baseline|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
11168707|NCT01987453|BG003|Baseline|Total|Total of all reporting groups
11168708|NCT01987453|FG000|Participant Flow|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11168709|NCT01987453|FG001|Participant Flow|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
11168710|NCT01987453|FG002|Participant Flow|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
11168711|NCT01987453|OG000|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11168712|NCT01987453|OG001|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
11168713|NCT01987453|OG002|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
11168714|NCT01987453|OG001|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
11168715|NCT01987453|OG002|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
11168716|NCT01987453|OG000|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11168717|NCT01987453|OG001|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
11168718|NCT01987453|EG000|Reported Event|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11168719|NCT01987453|EG001|Reported Event|LDV/SOF 24 Week (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
11354840|NCT03817775|EG000|Reported Event|Control|The control group underwent coronary angiography without music intervention.
11168720|NCT01987453|EG002|Reported Event|LDV/SOF + RBV 24 Week (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
11232366|NCT02418234|OG001|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
11232367|NCT02418234|OG002|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
11232368|NCT02418234|EG000|Reported Event|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment.
11232369|NCT02418312|BG000|Baseline|Histamine-2 Receptor Antagonist Group|"famotidine 40mg qd for 6 months.~histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine"
11232370|NCT02418312|BG001|Baseline|Placebo Group|"placebo for 6 months.~Placebo: placebo plus thienopyridine"
11232371|NCT02418312|BG002|Baseline|Total|Total of all reporting groups
11232372|NCT02418312|FG000|Participant Flow|Histamine-2 Receptor Antagonist Group|"famotidine 40mg qd for 6 months.~histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine"
11232373|NCT02418312|FG001|Participant Flow|Placebo Group|"placebo for 6 months.~Placebo: placebo plus thienopyridine"
11232374|NCT02418312|OG000|Outcome|Histamine-2 Receptor Antagonist Group|"famotidine 40mg qd for 6 months.~histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine"
11232375|NCT02418312|OG001|Outcome|Placebo Group|"placebo for 6 months.~Placebo: placebo plus thienopyridine"
11232376|NCT02418312|EG000|Reported Event|Histamine-2 Receptor Antagonist Group|"famotidine 40mg qd for 6 months.~histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine"
11232377|NCT02418312|EG001|Reported Event|Placebo Group|"placebo for 6 months.~Placebo: placebo plus thienopyridine"
11232378|NCT02418455|BG000|Baseline|UX003|UX003 4 mg/kg QOW. Initial treatment period 48 weeks. Continuation period up to 240 weeks.
11232379|NCT02418455|FG000|Participant Flow|UX003|UX003 4 mg/kg every other week (QOW). Initial treatment period 48 weeks. Continuation period up to 240 weeks.
11232380|NCT02418455|OG000|Outcome|UX003|UX003 4 mg/kg QOW. Initial treatment period 48 weeks. Continuation period up to 240 weeks.
11232381|NCT02418455|OG000|Outcome|UX003: eIND|"UX003 4 mg/kg QOW. Initial treatment period 48 weeks. Continuation period up to 240 weeks.~Participant previously treated with UX003 under an emergency Investigational New Drug (eIND) application."
11232382|NCT02418455|OG001|Outcome|UX003: Non-eIND|UX003 4 mg/kg QOW. Initial treatment period 48 weeks. Continuation period up to 240 weeks.
11232383|NCT02418455|EG000|Reported Event|UX003|UX003 4 mg/kg QOW. Initial treatment period 48 weeks. Continuation period up to 240 weeks.
11232384|NCT02418468|BG000|Baseline|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11232385|NCT02418468|BG001|Baseline|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11232386|NCT02418468|BG002|Baseline|Total|Total of all reporting groups
11232387|NCT02418468|FG000|Participant Flow|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11232388|NCT02418468|FG001|Participant Flow|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11232389|NCT02418468|OG000|Outcome|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11232390|NCT02418468|OG001|Outcome|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11232391|NCT02418468|EG000|Reported Event|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11232392|NCT02418468|EG001|Reported Event|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11232393|NCT02418546|BG000|Baseline|In-Person Nutritional Counseling|"Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.~In-Person Nutritional Counseling by a Registered Dietitian"
11232394|NCT02418546|BG001|Baseline|E-Health App for Nutritional Counseling|"Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.~Nutritional counseling using an e-Health Application"
11232395|NCT02418546|BG002|Baseline|Standard Care|Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
11232396|NCT02418546|BG003|Baseline|Total|Total of all reporting groups
11232397|NCT02418546|FG000|Participant Flow|In-Person Nutritional Counseling|"Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.~In-Person Nutritional Counseling by a Registered Dietitian"
11232398|NCT02418546|FG001|Participant Flow|E-Health App for Nutritional Counseling|"Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.~Nutritional counseling using an e-Health Application"
11232399|NCT02418546|FG002|Participant Flow|Standard Care|Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
10887998|NCT00504231|OG000|Outcome|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
11354841|NCT03817775|EG001|Reported Event|Music Therapy|"The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.~Music therapy: The intervention group administered U sequence between 10 minutes prior to the beginning of the procedure until its end."
11354842|NCT03843372|BG000|Baseline|First Night HFNC Group|The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy.
11354843|NCT03843372|BG001|Baseline|First Night CPAP Group|The first night will receive continuous positive airway pressure(CPAP) and the second accept high flow nasal cannula(HFNC) therapy.
11354844|NCT03843372|BG002|Baseline|Total|Total of all reporting groups
11354845|NCT03843372|FG000|Participant Flow|HFNC First, Then CPAP|Participants first received high flow nasal cannula (HFNC) for one night. After a washout period of one week, they then received continuous positive airway pressure (CPAP) for one night.
11354846|NCT03843372|FG001|Participant Flow|CPAP First, Then HFNC|Participants first received continuous positive airway pressure (CPAP) for one night. After a washout period of one week, they then received high flow nasal cannula (HFNC) for one night.
11354847|NCT03843372|OG000|Outcome|CPAP|The polysomnography data of 28 participants treated with one night CPAP.
11354848|NCT03843372|OG001|Outcome|HFNC|The polysomnography data of 28 participants received one night HFNC therapy.
11354849|NCT03843372|EG000|Reported Event|CPAP|The polysomnography data of 28 participants received one night CPAP therapy.
11354850|NCT03843372|EG001|Reported Event|HFNC|The polysomnography data of 28 participants received one night HFNC therapy.
11354851|NCT03841331|BG000|Baseline|Placebo|Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
11354852|NCT03841331|BG001|Baseline|Serlopitant 5 mg|Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
11354853|NCT03841331|BG002|Baseline|Total|Total of all reporting groups
11354854|NCT03841331|FG000|Participant Flow|Placebo|Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
11354855|NCT03841331|FG001|Participant Flow|Serlopitant 5 mg|Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
11354856|NCT03841331|OG000|Outcome|Placebo|Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
11354857|NCT03841331|OG001|Outcome|Serlopitant 5 mg|Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
11354858|NCT03841331|EG000|Reported Event|Placebo|Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
11354859|NCT03841331|EG001|Reported Event|Serlopitant 5 mg|Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
11354860|NCT03840278|BG000|Baseline|All Study Participants|"Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).~Participants were randomized to either first use the bihormonal iLet bionic pancreas for 1 week followed by the insulin-only iLet bionic pancreas for 1 week or to first use the insulin-only iLet bionic pancreas for 1 week followed by the bihormonal iLet for 1 week."
11354861|NCT03840278|FG000|Participant Flow|Bihormonal iLet Bionic Pancreas First, Then Insulin-Only|"Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).~For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week without a washout period."
11354862|NCT03840278|FG001|Participant Flow|Insulin-Only iLet Bionic Pancreas First, Then Bihormonal|"Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).~For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week without a washout period."
11357352|NCT03760913|OG004|Outcome|160 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg
10887999|NCT00504231|OG001|Outcome|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
11168721|NCT01987479|BG000|Baseline|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
11168722|NCT01987479|FG000|Participant Flow|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly subcutaneous (SC) injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) for 24 weeks.
11168723|NCT01987479|OG000|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
11168724|NCT01987479|EG000|Reported Event|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
11168725|NCT01987505|BG000|Baseline|Diffuse Large B-Cell Lymphoma|Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
11168726|NCT01987505|BG001|Baseline|Follicular Lymphoma|Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
11168727|NCT01987505|BG002|Baseline|Total|Total of all reporting groups
11168728|NCT01987505|FG000|Participant Flow|Subcutaneous Rituximab|Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
11168729|NCT01987505|OG000|Outcome|Diffuse Large B-Cell Lymphoma (DLBCL)|Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
11168730|NCT01987505|OG001|Outcome|Follicular Lymphoma (FL)|Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
11168731|NCT01987505|OG002|Outcome|Subcutaneous Rituximab|Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
11168732|NCT01987505|EG000|Reported Event|Subcutaneous Rituximab|Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
11168733|NCT01987557|BG000|Baseline|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
11168734|NCT01987557|BG001|Baseline|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
11168735|NCT01987557|BG002|Baseline|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
11168736|NCT01987557|BG003|Baseline|Total|Total of all reporting groups
11168737|NCT01987557|FG000|Participant Flow|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
11168738|NCT01987557|FG001|Participant Flow|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
11168739|NCT01987557|FG002|Participant Flow|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
11354863|NCT03840278|OG000|Outcome|Bihormonal iLet Bionic Pancreas|"Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.~Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon~Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas"
11354864|NCT03840278|OG001|Outcome|Insulin-Only iLet Bionic Pancreas|"Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.~Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin"
11354865|NCT03840278|EG000|Reported Event|Bihormonal iLet Bionic Pancreas|"Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.~Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon~Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas"
11354866|NCT03840278|EG001|Reported Event|Insulin-Only iLet Bionic Pancreas|"Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.~Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin"
11354867|NCT03840135|BG000|Baseline|Polyoxidonium 6 mg/ml|"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.~Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:~in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."
11354868|NCT03840135|BG001|Baseline|Placebo|"Placebo, nasal and sublingual spray - 7 days.~Placebo: Placebo nasal and sublingual spray will be administered for 7 days:~in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."
11354869|NCT03840135|BG002|Baseline|Total|Total of all reporting groups
11354870|NCT03840135|FG000|Participant Flow|Polyoxidonium 6 mg/ml|"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.~Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:~in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."
11354871|NCT03840135|FG001|Participant Flow|Placebo|"Placebo, nasal and sublingual spray - 7 days.~Placebo: Placebo nasal and sublingual spray will be administered for 7 days:~in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."
11354872|NCT03840135|OG000|Outcome|Polyoxidonium 6 mg/ml|"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.~Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:~in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."
11354873|NCT03840135|OG001|Outcome|Placebo|"Placebo, nasal and sublingual spray - 7 days.~Placebo: Placebo nasal and sublingual spray will be administered for 7 days:~in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours)."
11354874|NCT03840135|OG000|Outcome|Polyoxidonium 6 mg/ml|"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.~Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:~in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."
11357353|NCT03760913|OG005|Outcome|5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg
11354875|NCT03840135|OG001|Outcome|Placebo|"Placebo, nasal and sublingual spray - 7 days.~Placebo: Placebo nasal and sublingual spray will be administered for 7 days:~in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."
11354876|NCT03840135|OG000|Outcome|Polyoxidonium 6 mg/ml|"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.~Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:~in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours)."
11354877|NCT03840135|OG001|Outcome|Placebo|"Placebo, nasal and sublingual spray - 7 days.~Placebo: Placebo nasal and sublingual spray will be administered for 7 days:~in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours)."
11354878|NCT03840135|EG000|Reported Event|Polyoxidonium 6 mg/ml|"Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.~Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:~in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."
11354879|NCT03840135|EG001|Reported Event|Placebo|"Placebo, nasal and sublingual spray - 7 days.~Placebo: Placebo nasal and sublingual spray will be administered for 7 days:~in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours)."
11354880|NCT03839641|BG000|Baseline|High-fat Meal, Washout (5-7 Days), and Low-fat Meal|"Arm 1 participants randomized to receive high fat meal first, and low fat meal second~High fat meal: 60% fat meal~Low fat meal: 20% fat meal"
11354881|NCT03839641|BG001|Baseline|Low-fat Meal, Washout (5-7 Days), and High-fat Meal|"Arm 2 participants randomized to receive low fat meal first, and high fat meal second~High fat meal: 60% fat meal~Low fat meal: 20% fat meal"
11354882|NCT03839641|BG002|Baseline|Total|Total of all reporting groups
11354883|NCT03839641|FG000|Participant Flow|High-fat Meal, Washout (5-7 Days), and Low-fat Meal|"Arm 1 participants randomized to receive high fat meal first, and low fat meal second~High fat meal: 60% fat meal~Low fat meal: 20% fat meal"
11354884|NCT03839641|FG001|Participant Flow|Low-fat Meal, Washout (5-7 Days), and High-fat Meal|"Arm 2 participants randomized to receive low fat meal first, and high fat meal second~High fat meal: 60% fat meal~Low fat meal: 20% fat meal"
11354885|NCT03839641|OG000|Outcome|High Fat Meal|overnight respiratory exchange ratio following high-fat meal
11354886|NCT03839641|OG001|Outcome|Low-fat Meal|overnight respiratory exchange ratio following low-fat meal
11354887|NCT03839641|OG000|Outcome|High Fat Meal|change in respiratory exchange ratio following high-fat meal
11354888|NCT03839641|OG001|Outcome|Low-fat Meal|change in respiratory exchange ratio following low-fat meal
11354889|NCT03839641|EG000|Reported Event|High-fat Meal|High fat meal: 60% fat meal
11354890|NCT03839641|EG001|Reported Event|Low-fat Meal|Low fat meal: 20% fat meal
11354891|NCT03839212|BG000|Baseline|Happy Older Latinos Are Active (HOLA)|"A 16-week multi-component, health promotion intervention~HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.~HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.~HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.~HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement."
11354892|NCT03839212|FG000|Participant Flow|Happy Older Latinos Are Active (HOLA)|"A 16-week multi-component, health promotion intervention~HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.~HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.~HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.~HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement."
11354893|NCT03839212|OG000|Outcome|Happy Older Latinos Are Active (HOLA)|"A 16-week multi-component, health promotion intervention~HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.~HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.~HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.~HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement."
11232400|NCT02418546|OG000|Outcome|In-Person Nutritional Counseling|"Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.~In-Person Nutritional Counseling by a Registered Dietitian"
11232401|NCT02418546|OG001|Outcome|E-Health App for Nutritional Counseling|"Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.~Nutritional counseling using an e-Health Application"
11232402|NCT02418546|OG002|Outcome|Standard Care|Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
11232403|NCT02418546|EG000|Reported Event|In-Person Nutritional Counseling|"Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.~In-Person Nutritional Counseling by a Registered Dietitian"
11232404|NCT02418546|EG001|Reported Event|E-Health App for Nutritional Counseling|"Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.~Nutritional counseling using an e-Health Application"
11232405|NCT02418546|EG002|Reported Event|Standard Care|Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
11232406|NCT02418585|BG000|Baseline|Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)|Participants self-administered (under direct supervision by HCP) esketamine 56 milligram (mg) or 84 mg intranasally twice weekly for 4 weeks (on Day 1,4,8,11,15,18,22,25). Simultaneously, participants initiated per fixed titration scheme a new open-label oral AD with one of following: [Duloxetine (60 milligram (mg)/day- Weeks 1-4 with minimum dose for tolerability [MDT] of 60 mg/day); Escitalopram (10 mg/day-Week 1 and 20 mg/day- Weeks 2-4 with MDT of 10 mg/day); Sertraline (50 mg/day-Week 1, 100 mg/day-Week 2, 150 mg/day-Week 3 and 200 mg/day-Week 4 with MDT of 50 mg/day) or Venlafaxine XR (75 mg/day-Week 1, 150 mg/day-Week 2, and 225 mg/day-Weeks 3 and 4 with MDT of 150 mg/day) during DB Induction Phase. Participants who were not eligible or who chose to not participate in maintenance of effect study (ESKETINTRD3003[NCT02493868]) and had received at least 1 dose of intranasal Esketamine+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232407|NCT02418585|BG001|Baseline|Intranasal Placebo Plus Oral AD|Participants self-administered (under direct supervision by HCP) esketamine matched placebo intranasally twice weekly for 4 weeks (on Day 1,4,8,11,15,18,22 and 25). Simultaneously, participants initiated per fixed titration scheme a new open-label oral AD with one of following: [Duloxetine (60 milligram (mg)/day- Weeks 1-4 with minimum dose for tolerability [MDT] of 60 mg/day); Escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2-4 with MDT of 10 mg/day); Sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MDT of 50 mg/day) or Venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, and 225 mg/day- Weeks 3 and 4 with MDT of 150 mg/day) during DB Induction Phase. Participants who were not eligible or who chose to not participate in maintenance of effect study (ESKETINTRD3003 [NCT02493868]) and had received at least 1 dose of intranasal Placebo+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232408|NCT02418585|BG002|Baseline|Total|Total of all reporting groups
11232409|NCT02418585|FG000|Participant Flow|Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)|Participants self-administered (under direct supervision by HCP) esketamine 56 milligram (mg) or 84 mg intranasally twice weekly for 4 weeks (on Day 1,4,8,11,15,18,22,25). Simultaneously, participants initiated per fixed titration scheme a new open-label oral AD with one of following: [Duloxetine (60 milligram (mg)/day- Weeks 1-4 with minimum dose for tolerability [MDT] of 60 mg/day); Escitalopram (10 mg/day-Week 1 and 20 mg/day- Weeks 2-4 with MDT of 10 mg/day); Sertraline (50 mg/day-Week 1, 100 mg/day-Week 2, 150 mg/day-Week 3 and 200 mg/day-Week 4 with MDT of 50 mg/day) or Venlafaxine XR (75 mg/day-Week 1, 150 mg/day-Week 2, and 225 mg/day-Weeks 3 and 4 with MDT of 150 mg/day) during DB Induction Phase. Participants who were not eligible or who chose to not participate in maintenance of effect study (ESKETINTRD3003[NCT02493868]) and had received at least 1 dose of intranasal Esketamine+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232410|NCT02418585|FG001|Participant Flow|Intranasal Placebo Plus Oral AD|Participants self-administered (under direct supervision by HCP) esketamine matched placebo intranasally twice weekly for 4 weeks (on Day 1,4,8,11,15,18,22 and 25). Simultaneously, participants initiated per fixed titration scheme a new open-label oral AD with one of following: [Duloxetine (60 milligram (mg)/day- Weeks 1-4 with minimum dose for tolerability [MDT] of 60 mg/day); Escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2-4 with MDT of 10 mg/day); Sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MDT of 50 mg/day) or Venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, and 225 mg/day- Weeks 3 and 4 with MDT of 150 mg/day) during DB Induction Phase. Participants who were not eligible or who chose to not participate in maintenance of effect study (ESKETINTRD3003 [NCT02493868]) and had received at least 1 dose of intranasal Placebo+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11357354|NCT03760913|OG006|Outcome|5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg
10888000|NCT00504231|OG002|Outcome|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
11354894|NCT03839212|EG000|Reported Event|Happy Older Latinos Are Active (HOLA)|"A 16-week multi-component, health promotion intervention~HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.~HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.~HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.~HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement."
11354895|NCT03839355|BG000|Baseline|Eliquis|Apixaban: Dosage either 5mg or 2.5mg for 2 years
11354896|NCT03839355|BG001|Baseline|Warfarin|Warfarin: Dosage assessed by your treating physician for 2 years
11354897|NCT03839355|BG002|Baseline|Total|Total of all reporting groups
11354898|NCT03839355|FG000|Participant Flow|Eliquis|Apixaban: Dosage either 5mg or 2.5mg for 2 years
11354899|NCT03839355|FG001|Participant Flow|Warfarin|Warfarin: Dosage assessed by your treating physician for 2 years
11354900|NCT03839355|OG000|Outcome|Eliquis|Apixaban: Dosage either 5mg or 2.5mg for 2 years
11354901|NCT03839355|OG001|Outcome|Warfarin|Warfarin: Dosage assessed by your treating physician for 2 years
11354902|NCT03839355|EG000|Reported Event|Eliquis|Apixaban: Dosage either 5mg or 2.5mg for 2 years
11354903|NCT03839355|EG001|Reported Event|Warfarin|Warfarin: Dosage assessed by your treating physician for 2 years
11354904|NCT03838874|BG000|Baseline|Low-Dose Bupivacaine|"Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.~Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic"
10888001|NCT00504231|OG003|Outcome|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
11354905|NCT03838874|BG001|Baseline|Mepivacaine|"Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.~Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic"
11354906|NCT03838874|BG002|Baseline|Total|Total of all reporting groups
11354907|NCT03838874|FG000|Participant Flow|Low-Dose Bupivacaine|"Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.~Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic"
11354908|NCT03838874|FG001|Participant Flow|Mepivacaine|"Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.~Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic"
11354909|NCT03838874|OG000|Outcome|Low-Dose Bupivacaine|"Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.~Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic"
11354910|NCT03838874|OG001|Outcome|Mepivacaine|"Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.~Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic"
11354911|NCT03838874|EG000|Reported Event|Low-Dose Bupivacaine|"Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.~Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic"
11354912|NCT03838874|EG001|Reported Event|Mepivacaine|"Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.~Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic"
11354913|NCT03838731|BG000|Baseline|Placebo|Participants received a single dose of matching placebo
11354914|NCT03838731|BG001|Baseline|REGN1908-1909 600 mg|Participants received a single 600 mg dose of REGN1908-1909
11354915|NCT03838731|BG002|Baseline|Total|Total of all reporting groups
11354916|NCT03838731|FG000|Participant Flow|Placebo|Participants received a single dose of matching placebo
11354917|NCT03838731|FG001|Participant Flow|REGN1908-1909 600 mg|Participants received a single 600 mg dose of REGN1908-1909
11354918|NCT03838731|OG000|Outcome|Placebo|Participants received a single dose of matching placebo
11354919|NCT03838731|OG001|Outcome|REGN1908-1909 600 mg|Participants received a single 600 mg dose of REGN1908-1909
11354920|NCT03838731|EG000|Reported Event|Placebo|Participants received a single dose of matching placebo
11354921|NCT03838731|EG001|Reported Event|REGN1908-1909 600mg|Participants received a single 600 mg dose of REGN1908-1909
11354922|NCT03838198|BG000|Baseline|Phase 1 - Safety Plan|Participants who received the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies
11354923|NCT03838198|BG001|Baseline|Phase 1 - Safety Plan & Text Messages|Participants who received the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
11354924|NCT03838198|BG002|Baseline|Total|Total of all reporting groups
11354925|NCT03838198|FG000|Participant Flow|Safety Plan + Booster Text Messages + Booster Call|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies -- which will be followed by 4 weeks of daily post-discharge booster text messages and in Period/Phase 2 a phone booster call.
11354926|NCT03838198|FG001|Participant Flow|Safety Plan + Booster Text Messages|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge without booster phone call.
11357355|NCT03760913|OG007|Outcome|5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg
11232411|NCT02418585|OG000|Outcome|Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)|Participants self-administered (under direct supervision by HCP) esketamine 56 milligram (mg) or 84 mg intranasally twice weekly for 4 weeks (on Day 1,4,8,11,15,18,22,25). Simultaneously, participants initiated per fixed titration scheme a new open-label oral AD with one of following: [Duloxetine (60 milligram (mg)/day- Weeks 1-4 with minimum dose for tolerability [MDT] of 60 mg/day); Escitalopram (10 mg/day-Week 1 and 20 mg/day- Weeks 2-4 with MDT of 10 mg/day); Sertraline (50 mg/day-Week 1, 100 mg/day-Week 2, 150 mg/day-Week 3 and 200 mg/day-Week 4 with MDT of 50 mg/day) or Venlafaxine XR (75 mg/day-Week 1, 150 mg/day-Week 2, and 225 mg/day-Weeks 3 and 4 with MDT of 150 mg/day) during DB Induction Phase. Participants who were not eligible or who chose to not participate in maintenance of effect study (ESKETINTRD3003[NCT02493868]) and had received at least 1 dose of intranasal Esketamine+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232412|NCT02418585|OG001|Outcome|Intranasal Placebo Plus Oral AD|Participants self-administered (under direct supervision by HCP) esketamine matched placebo intranasally twice weekly for 4 weeks (on Day 1,4,8,11,15,18,22 and 25). Simultaneously, participants initiated per fixed titration scheme a new open-label oral AD with one of following: [Duloxetine (60 milligram (mg)/day- Weeks 1-4 with minimum dose for tolerability [MDT] of 60 mg/day); Escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2-4 with MDT of 10 mg/day); Sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MDT of 50 mg/day) or Venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, and 225 mg/day- Weeks 3 and 4 with MDT of 150 mg/day) during DB Induction Phase. Participants who were not eligible or who chose to not participate in maintenance of effect study (ESKETINTRD3003 [NCT02493868]) and had received at least 1 dose of intranasal Placebo+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232413|NCT02418585|EG000|Reported Event|DB Phase: Intranasal Esk + Oral AD|Participants self-administered (under direct supervision by health care professional [HCP]) esketamine either 56 milligram (mg) or 84 mg intranasally twice weekly for 4 weeks (on Day 1, 4, 8, 11, 15, 18, 22 and 25). Simultaneously, participants initiated per fixed titration scheme a new open-label oral antidepressant (AD) with one of following: [Duloxetine (60 milligram (mg)/day- Weeks 1-4 with minimum dose for tolerability [MDT] of 60 mg/day); Escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2-4 with MDT of 10 mg/day); Sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MDT of 50 mg/day) or Venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, and 225 mg/day- Weeks 3 and 4 with MDT of 150 mg/day) during DB Induction Phase.
11232414|NCT02418585|EG001|Reported Event|DB Phase: Oral AD + Intranasal Placebo|Participants self-administered (under direct supervision by HCP) esketamine matched placebo intranasally twice weekly for 4 weeks (on Day 1, 4, 8, 11, 15, 18, 22 and 25). Simultaneously, participants initiated per fixed titration scheme a new open-label oral AD with one of following: [Duloxetine (60 milligram (mg)/day- Weeks 1-4 with minimum dose for tolerability [MDT] of 60 mg/day); Escitalopram (10 mg/day- Week 1 and 20 mg/day- Weeks 2-4 with MDT of 10 mg/day); Sertraline (50 mg/day- Week 1, 100 mg/day- Week 2, 150 mg/day- Week 3 and 200 mg/day- Week 4 with MDT of 50 mg/day) or Venlafaxine XR (75 mg/day- Week 1, 150 mg/day- Week 2, and 225 mg/day- Weeks 3 and 4 with MDT of 150 mg/day) during DB Induction Phase.
11232415|NCT02418585|EG002|Reported Event|FU Phase: Intranasal Esk + Oral AD|Participants who were not eligible or who chose to not participate in maintenance of effect study (ESKETINTRD3003 [NCT02493868]) and had received at least 1 dose of intranasal Esk+ Oral AD in DB induction phase were followed in posttreatment follow-up (FU) phase for up to 24 weeks.
11232416|NCT02418585|EG003|Reported Event|FU Phase: Oral AD + Intranasal Placebo|Participants who were not eligible or who chose to not participate in maintenance of effect study (ESKETINTRD3003 [NCT02493868]) and had received at least 1 dose of intranasal Placebo+ Oral AD in DB induction phase were followed in posttreatment follow-up phase for up to 24 weeks.
11232417|NCT02418676|BG000|Baseline|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232418|NCT02418676|BG001|Baseline|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232419|NCT02418676|BG002|Baseline|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232420|NCT02418676|BG003|Baseline|Total|Total of all reporting groups
11357356|NCT03760913|OG008|Outcome|5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg
11168740|NCT01987557|OG000|Outcome|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
11168741|NCT01987557|OG001|Outcome|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
11168742|NCT01987557|OG002|Outcome|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
11168743|NCT01987557|EG000|Reported Event|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
11168744|NCT01987557|EG001|Reported Event|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
11168745|NCT01987557|EG002|Reported Event|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
11168746|NCT01987583|BG000|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11168747|NCT01987583|BG001|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11168748|NCT01987583|BG002|Baseline|Total|Total of all reporting groups
11168749|NCT01987583|FG000|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11168750|NCT01987583|FG001|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11168751|NCT01987583|OG000|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11168752|NCT01987583|OG001|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11168753|NCT01987583|EG000|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11354927|NCT03838198|FG002|Participant Flow|Safety Plan + Booster Call|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.
11354928|NCT03838198|FG003|Participant Flow|Safety Plan|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization with neither follow-up text messages nor booster phone call.
11354929|NCT03838198|OG000|Outcome|All Eligible Youth|Potential participants prior to randomization
11354930|NCT03838198|OG000|Outcome|Safety Plan + Booster Text Messages + Booster Call (Group A)|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
11354931|NCT03838198|OG001|Outcome|Safety Plan + Booster Text Messages (Group B)|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
11354932|NCT03838198|OG002|Outcome|Safety Plan + Booster Call (Group C)|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.
11354933|NCT03838198|OG003|Outcome|Safety Plan (Group D)|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.
11354934|NCT03838198|EG000|Reported Event|Safety Plan + Booster Text Messages + Booster Call (Group A)|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
11354935|NCT03838198|EG001|Reported Event|Safety Plan + Booster Text Messages (Group B)|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
11354936|NCT03838198|EG002|Reported Event|Safety Plan + Booster Call (Group C)|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.
11354937|NCT03838198|EG003|Reported Event|Safety Plan (Group D)|Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.
11354938|NCT03831451|BG000|Baseline|Stroke Preparedness Intervention|"The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.~Stroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes"
11354939|NCT03831451|BG001|Baseline|Healthy Lifestyle Intervention|"The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.~Healthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes"
11354940|NCT03831451|BG002|Baseline|Total|Total of all reporting groups
11354941|NCT03831451|FG000|Participant Flow|Stroke Preparedness Intervention|"The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.~Stroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes"
11354942|NCT03831451|FG001|Participant Flow|Healthy Lifestyle Intervention|"The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.~Healthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes"
11354943|NCT03831451|OG000|Outcome|Stroke Preparedness Intervention|"The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.~Stroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes"
10888002|NCT00504231|EG000|Reported Event|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
10888003|NCT00504231|EG001|Reported Event|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
10888004|NCT00504231|EG002|Reported Event|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
10888005|NCT00504231|EG003|Reported Event|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
11354944|NCT03831451|OG001|Outcome|Healthy Lifestyle Intervention|"The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.~Healthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes"
11354945|NCT03831451|EG000|Reported Event|Stroke Preparedness Intervention|"The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.~Stroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes"
10888006|NCT00504257|BG000|Baseline|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
11089731|NCT01524991|EG000|Reported Event|Treatment|"Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)~Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)~Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)~Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)"
11232421|NCT02418676|FG000|Participant Flow|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232422|NCT02418676|FG001|Participant Flow|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232423|NCT02418676|FG002|Participant Flow|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232424|NCT02418676|OG000|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232425|NCT02418676|OG001|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232426|NCT02418676|OG002|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11233970|NCT02431637|BG000|Baseline|Piperaquine Phosphate After Infected Blood Malaria Challenge|"Volunteers will receive a dose of 480 mg piperaquine phosphate (PQP) approx. 7 days after a challenge with P. falciparum infected red blood cells. The effects of PQP on gametocyte carriage (assessed by PCR) and infectivity to mosquitos after direct and indirect feeding on blood from volunteers will be assessed.~Administration of the malaria inoculum: Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL.~Piperaquine Phosphate 480 mg: When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate."
11232427|NCT02418676|EG000|Reported Event|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232428|NCT02418676|EG001|Reported Event|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232429|NCT02418676|EG002|Reported Event|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
11232430|NCT02418754|BG000|Baseline|Group 1: REGN2176-3 (1 mg:2 mg)|Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232431|NCT02418754|BG001|Baseline|Group 2: REGN2176-3 (3 mg:2 mg)|Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232432|NCT02418754|BG002|Baseline|Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg|IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232433|NCT02418754|BG003|Baseline|Total|Total of all reporting groups
11232434|NCT02418754|FG000|Participant Flow|Group 1: REGN2176-3 (1 mg:2 mg)|Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232435|NCT02418754|FG001|Participant Flow|Group 2: REGN2176-3 (3 mg:2 mg)|Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232436|NCT02418754|FG002|Participant Flow|Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg|IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232437|NCT02418754|FG003|Participant Flow|Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg|Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 4 was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.
11232438|NCT02418754|FG004|Participant Flow|Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg)|IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 5 was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
11232439|NCT02418754|OG000|Outcome|Group 1: REGN2176-3 (1 mg:2 mg)|Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232440|NCT02418754|OG001|Outcome|Group 2: REGN2176-3 (3 mg:2 mg)|Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232441|NCT02418754|OG002|Outcome|Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg|IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232442|NCT02418754|EG000|Reported Event|Group 1: REGN2176-3 (1 mg:2 mg)|Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232443|NCT02418754|EG001|Reported Event|Group 2: REGN2176-3 (3 mg:2 mg)|Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232444|NCT02418754|EG002|Reported Event|Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg|IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
11232445|NCT02418754|EG003|Reported Event|Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg|Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 4 was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.
11232446|NCT02418754|EG004|Reported Event|Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg)|IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 5 was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
11232447|NCT02418819|BG000|Baseline|PF-06412562 3 mg BID|Participant received 3 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232448|NCT02418819|BG001|Baseline|PF-06412562 9 mg BID|Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232449|NCT02418819|BG002|Baseline|PF-06412562 45 mg BID|Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose.
11232450|NCT02418819|BG003|Baseline|Placebo|Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232451|NCT02418819|BG004|Baseline|Total|Total of all reporting groups
11232452|NCT02418819|FG000|Participant Flow|PF-06412562 3 mg BID|Participant received 3 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232453|NCT02418819|FG001|Participant Flow|PF-06412562 9 mg BID|Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232454|NCT02418819|FG002|Participant Flow|PF-06412562 45 mg BID|Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose.
11232455|NCT02418819|FG003|Participant Flow|Placebo|Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232456|NCT02418819|OG000|Outcome|PF-06412562 3 mg BID|Participant received 3 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232457|NCT02418819|OG001|Outcome|PF-06412562 9 mg BID|Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232458|NCT02418819|OG002|Outcome|PF-06412562 45 mg BID|Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose.
11232459|NCT02418819|OG003|Outcome|Placebo|Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232460|NCT02418819|EG000|Reported Event|PF-06412562 3 mg BID|Participant received 3 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232461|NCT02418819|EG001|Reported Event|PF-06412562 9 mg BID|Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232462|NCT02418819|EG002|Reported Event|PF-06412562 45 mg BID|Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose.
11232463|NCT02418819|EG003|Reported Event|Placebo|Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
11232464|NCT02418845|BG000|Baseline|SYM-1219|"2 grams administered orally as a single dose~SYM-1219"
11232465|NCT02418845|BG001|Baseline|Placebo|"Administered orally as a single dose~Placebo"
11232466|NCT02418845|BG002|Baseline|Total|Total of all reporting groups
11232467|NCT02418845|FG000|Participant Flow|SYM-1219|"2 grams administered orally as a single dose~SYM-1219"
11232468|NCT02418845|FG001|Participant Flow|Placebo|"Administered orally as a single dose~Placebo"
11232469|NCT02418845|OG000|Outcome|SYM-1219|"2 grams administered orally as a single dose~SYM-1219"
11232470|NCT02418845|OG001|Outcome|Placebo|"Administered orally as a single dose~Placebo"
11232471|NCT02418845|EG000|Reported Event|SYM-1219|"2 grams administered orally as a single dose~SYM-1219"
11232472|NCT02418845|EG001|Reported Event|Placebo|"Administered orally as a single dose~Placebo"
11232473|NCT02418910|BG000|Baseline|Bipolar Outpatients in Any Clinical State - KIOS or eMoods|Patients with Bipolar Disorder. Study does not provide a treatment intervention.
11232474|NCT02418910|FG000|Participant Flow|Bipolar Outpatients in Any Clinical State|Patients with Bipolar Disorder. Study does not provide a treatment intervention.
11232475|NCT02418910|OG000|Outcome|Bipolar Outpatients in Any Clinical State|Patients with Bipolar Disorder. Study does not provide a treatment intervention.
11354946|NCT03831451|EG001|Reported Event|Healthy Lifestyle Intervention|"The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.~Healthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes"
11354947|NCT03822078|BG000|Baseline|Placebo|Participants received a single subcutaneous injection of placebo to denosumab on day 1.
11354948|NCT03822078|BG001|Baseline|Denosumab 0.03 mg/kg|Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
11354949|NCT03822078|BG002|Baseline|Denosumab 0.1 mg/kg|Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
11354950|NCT03822078|BG003|Baseline|Denosumab 0.3 mg/kg|Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
11354951|NCT03822078|BG004|Baseline|Denosumab 1.0 mg/kg|Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
11354952|NCT03822078|BG005|Baseline|Denosumab 3.0 mg/kg|Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
11232476|NCT02418910|EG000|Reported Event|Bipolar Outpatients in Any Clinical State|Patients with Bipolar Disorder. Study does not provide a treatment intervention.
11354953|NCT03822078|BG006|Baseline|Total|Total of all reporting groups
11354954|NCT03822078|FG000|Participant Flow|Placebo|Participants received a single subcutaneous injection of placebo to denosumab on day 1.
11354955|NCT03822078|FG001|Participant Flow|Denosumab 0.03 mg/kg|Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
11354956|NCT03822078|FG002|Participant Flow|Denosumab 0.1 mg/kg|Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
11354957|NCT03822078|FG003|Participant Flow|Denosumab 0.3 mg/kg|Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
11354958|NCT03822078|FG004|Participant Flow|Denosumab 1.0 mg/kg|Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
11354959|NCT03822078|FG005|Participant Flow|Denosumab 3.0 mg/kg|Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
11354960|NCT03822078|OG000|Outcome|Placebo|Participants received a single subcutaneous injection of placebo to denosumab on day 1.
11354961|NCT03822078|OG001|Outcome|Denosumab 0.03 mg/kg|Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
11354962|NCT03822078|OG002|Outcome|Denosumab 0.1 mg/kg|Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
11354963|NCT03822078|OG003|Outcome|Denosumab 0.3 mg/kg|Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
11354964|NCT03822078|OG004|Outcome|Denosumab 1.0 mg/kg|Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
11354965|NCT03822078|OG005|Outcome|Denosumab 3.0 mg/kg|Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
11354966|NCT03822078|OG000|Outcome|Denosumab 0.03 mg/kg|Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
11354967|NCT03822078|OG001|Outcome|Denosumab 0.1 mg/kg|Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
11354968|NCT03822078|OG002|Outcome|Denosumab 0.3 mg/kg|Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
11354969|NCT03822078|OG003|Outcome|Denosumab 1.0 mg/kg|Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
11354970|NCT03822078|OG004|Outcome|Denosumab 3.0 mg/kg|Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
11354971|NCT03822078|EG000|Reported Event|Placebo|Participants received a single subcutaneous injection of placebo to denosumab on day 1.
11354972|NCT03822078|EG001|Reported Event|Denosumab 0.03 mg/kg|Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
11354973|NCT03822078|EG002|Reported Event|Denosumab 0.1 mg/kg|Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
11354974|NCT03822078|EG003|Reported Event|Denosumab 0.3 mg/kg|Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
11354975|NCT03822078|EG004|Reported Event|Denosumab 1.0 mg/kg|Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
11354976|NCT03822078|EG005|Reported Event|Denosumab 3.0 mg/kg|Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
11354977|NCT03822078|EG006|Reported Event|Denosumab Total|All participants received a single subcutaneous injection of denosumab on day 1.
11354978|NCT03815240|BG000|Baseline|no Dressing, Mepilex, Allevyn, Optifoam (in Different Order)|Cross-over study. Each of the 12 participants received each intervention once (no dressing, Mepilex® Border Sacrum, ALLEVYN Life Sacrum, Optifoam® Gentle Sacrum)
11354979|NCT03815240|FG000|Participant Flow|No Dressing, Mepilex, Allevyn, Optifoam|"Dressing application order:~no dressing (A), Mepilex® Border Sacrum (B), ALLEVYN Life Sacrum (C), Optifoam® Gentle Sacrum (D)"
11354980|NCT03815240|FG001|Participant Flow|Mepilex, no Dressing, Optifoam, Allevyn|"Dressing application order:~Mepilex® Border Sacrum (B), no dressing (A), Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C)"
11354981|NCT03815240|FG002|Participant Flow|No Dressing, Mepilex, Optifoam, Allevyn|"Dressing application order:~no dressing (A), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C)"
11354982|NCT03815240|FG003|Participant Flow|No Dressing, Allevyn, Mepilex, Optifoam|"Dressing application order:~no dressing (A), ALLEVYN Life Sacrum (C), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D)"
11354983|NCT03815240|FG004|Participant Flow|Optifoam, Allevyn, no Dressing, Mepilex|"Dressing application order:~Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C), no dressing (A), Mepilex® Border Sacrum (B)"
11354984|NCT03815240|FG005|Participant Flow|Optifoam, Mepilex, Allevyn, no Dressing,|"Dressing application order:~Optifoam® Gentle Sacrum (D), Mepilex® Border Sacrum (B), ALLEVYN Life Sacrum (C), no dressing (A)"
11354985|NCT03815240|FG006|Participant Flow|Mepilex, Optifoam, no Dressing, Allevyn|"Dressing application order:~Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D), no dressing (A), ALLEVYN Life Sacrum (C)"
11354986|NCT03815240|FG007|Participant Flow|Allevyn, no Dressing, Mepilex, Optifoam|"Dressing application order:~ALLEVYN Life Sacrum (C), no dressing (A), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D)"
11354987|NCT03815240|FG008|Participant Flow|Optifoam, Allevyn, Mepilex, no Dressing|"Dressing application order:~Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C), Mepilex® Border Sacrum (B), no dressing (A)"
11354988|NCT03815240|OG000|Outcome|no Dressing (A)|No dressing was applied at sacrum before 3.5 hours loading period in supine position
11354989|NCT03815240|OG001|Outcome|Mepilex (B)|'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
11354990|NCT03815240|OG002|Outcome|Allevyn (C)|'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
11354991|NCT03815240|OG003|Outcome|Optifaom (D)|'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
11354992|NCT03815240|OG003|Outcome|Optifoam (D)|'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
11354993|NCT03815240|OG003|Outcome|Optofoam (D)|'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
11354994|NCT03815240|OG000|Outcome|no Dressing (A)|"No dressing was applied at sacrum before 3.5 hours loading period in supine position~No dressing: no dressing at sacrum"
11354995|NCT03815240|OG001|Outcome|Mepilex (B)|"'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position~Mepilex® Border Sacrum: adhesive sacrum dressing"
11354996|NCT03815240|OG002|Outcome|Allevyn (C)|"'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position~ALLEVYN Life Sacrum: adhesive sacrum dressing"
11354997|NCT03815240|OG003|Outcome|Optifaom (D)|"'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position~Optifoam® Gentle Sacrum: adhesive sacrum dressing"
11354998|NCT03815240|EG000|Reported Event|no Dressing (A)|No dressing was applied at sacrum before 3.5 hours loading period in supine position
11354999|NCT03815240|EG001|Reported Event|Mepilex (B)|'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
11355000|NCT03815240|EG002|Reported Event|Allevyn (C)|'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
11355001|NCT03815240|EG003|Reported Event|Optifoam (D)|'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
11355002|NCT03836859|BG000|Baseline|rhNGF 20μg/mL|"rhNGF 20μg/mL eye drop solution, formulation containing L-methionine as excipient.~rhNGF 20μg/mL: Study Eye (For subjects randomized to rhNGF group) Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF).~Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 4.20 μg of rhNGF).~Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6 days."
11355003|NCT03836859|BG001|Baseline|Placebo|"Vehicle: formulation containing L-methionine as excipient.~Placebo: Vehicle: formulation containing L-methionine as excipient."
11355004|NCT03836859|BG002|Baseline|Total|Total of all reporting groups
11355005|NCT03836859|FG000|Participant Flow|rhNGF 20μg/mL|"rhNGF 20μg/mL eye drop solution, formulation containing L-methionine as excipient.~rhNGF 20μg/mL: Study Eye (For subjects randomized to rhNGF group) Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF).~Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 4.20 μg of rhNGF).~Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6 days."
11355006|NCT03836859|FG001|Participant Flow|Placebo|"Vehicle: formulation containing L-methionine as excipient.~Placebo: Vehicle: formulation containing L-methionine as excipient."
11355007|NCT03836859|OG000|Outcome|rhNGF 20μg/mL|"rhNGF 20μg/mL eye drop solution, formulation containing L-methionine as excipient.~rhNGF 20μg/mL: Study Eye (For subjects randomized to rhNGF group) Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF).~Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 4.20 μg of rhNGF).~Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6 days."
11355008|NCT03836859|OG001|Outcome|Placebo|"Vehicle: formulation containing L-methionine as excipient.~Placebo: Vehicle: formulation containing L-methionine as excipient."
11355009|NCT03836859|EG000|Reported Event|rhNGF 20μg/mL|"rhNGF 20μg/mL eye drop solution, formulation containing L-methionine as excipient.~rhNGF 20μg/mL: Study Eye (For subjects randomized to rhNGF group) Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF).~Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 4.20 μg of rhNGF).~Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6 days."
11355010|NCT03836859|EG001|Reported Event|Placebo|"Vehicle: formulation containing L-methionine as excipient.~Placebo: Vehicle: formulation containing L-methionine as excipient."
11355011|NCT03835078|BG000|Baseline|Overall Study|Total Participants
11355012|NCT03835078|FG000|Participant Flow|Methalfilcon A Contact Lenses / Fanfilcon A Contact Lenses|"All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.~methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses~fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses"
11355013|NCT03835078|OG000|Outcome|Methalfilcon A Contact Lenses|"All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.~methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses"
11232477|NCT02418949|BG000|Baseline|Cyproheptadine + AMP|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.~Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy."
11232478|NCT02418949|BG001|Baseline|Placebo for Cyproheptadine + Stretching|"Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.~Dose will be titrated down to zero in the 2 weeks following treatment.~Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed."
11232479|NCT02418949|BG002|Baseline|Cyproheptadine + Stretching|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.~Dose will be titrated down to zero in the 2 weeks following treatment.~Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed."
11232480|NCT02418949|BG003|Baseline|Placebo for Cyproheptadine + AMP|"Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.~Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy."
11232481|NCT02418949|BG004|Baseline|Total|Total of all reporting groups
11232482|NCT02418949|FG000|Participant Flow|Cyproheptadine + AMP|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.~Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy."
11233971|NCT02431637|FG000|Participant Flow|Piperaquine Phosphate After Infected Blood Malaria Challenge|"Volunteers will receive a dose of 480 mg piperaquine phosphate (PQP) approx. 7 days after a challenge with P. falciparum infected red blood cells. The effects of PQP on gametocyte carriage (assessed by PCR) and infectivity to mosquitos after direct and indirect feeding on blood from volunteers will be assessed.~Administration of the malaria inoculum: Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL.~Piperaquine Phosphate 480 mg: When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate."
11355014|NCT03835078|OG000|Outcome|Fanfilcon A Contact Lenses|"All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.~fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses"
11355015|NCT03835078|EG000|Reported Event|Methafilcon A|"All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.~methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses"
11355016|NCT03835078|EG001|Reported Event|Fanfilcon A|"All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.~fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A"
11355017|NCT03834025|BG000|Baseline|Phase 1 Condition 1 (Recruitment as Usual)|Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.
11355018|NCT03834025|BG001|Baseline|Phase 1 Condition 2 (no Prosocial Messaging, Compensation)|Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.
11355019|NCT03834025|BG002|Baseline|Phase 1 Condition 3 (Prosocial Messaging, no Compensation)|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.
11355020|NCT03834025|BG003|Baseline|Phase 1 Condition 4 (Prosocial Messaging, Compensation)|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.
11355021|NCT03834025|BG004|Baseline|Phase 2 Condition 1 (no Compensation)|Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.
11355022|NCT03834025|BG005|Baseline|Phase 2 Condition 2 (30% Compensation)|Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.
11355023|NCT03834025|BG006|Baseline|Phase 2 Condition 3 (100% Compensation)|Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.
11355024|NCT03834025|BG007|Baseline|Total|Total of all reporting groups
11355025|NCT03834025|FG000|Participant Flow|Phase 1 Condition 1 (Recruitment as Usual)|Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.
11355026|NCT03834025|FG001|Participant Flow|Phase 1 Condition 2 (no Prosocial Messaging, Compensation)|Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.
11355027|NCT03834025|FG002|Participant Flow|Phase 1 Condition 3 (Prosocial Messaging, no Compensation)|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.
11355028|NCT03834025|FG003|Participant Flow|Phase 1 Condition 4 (Prosocial Messaging, Compensation)|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.
11355029|NCT03834025|FG004|Participant Flow|Phase 2 Condition 1 (no Compensation)|Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.
11355030|NCT03834025|FG005|Participant Flow|Phase 2 Condition 2 (30% Compensation)|Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.
11355031|NCT03834025|FG006|Participant Flow|Phase 2 Condition 3 (100% Compensation)|Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.
11355032|NCT03834025|OG000|Outcome|Phase 1 Condition 1 (Recruitment as Usual)|Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.
11355033|NCT03834025|OG001|Outcome|Phase 1 Condition 2 (no Prosocial Messaging, Compensation)|Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.
11355034|NCT03834025|OG002|Outcome|Phase 1 Condition 3 (Prosocial Messaging, no Compensation)|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.
11355035|NCT03834025|OG003|Outcome|Phase 1 Condition 4 (Prosocial Messaging, Compensation)|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.
11355036|NCT03834025|OG004|Outcome|Phase 2 Condition 1 (no Compensation)|Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.
11355037|NCT03834025|OG005|Outcome|Phase 2 Condition 2 (30% Compensation)|Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.
11355038|NCT03834025|OG006|Outcome|Phase 2 Condition 3 (100% Compensation)|Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.
11355039|NCT03834025|EG000|Reported Event|Phase 1 Condition 1 (Recruitment as Usual)|Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.
11355040|NCT03834025|EG001|Reported Event|Phase 1 Condition 2 (no Prosocial Messaging, Compensation)|Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.
11355041|NCT03834025|EG002|Reported Event|Phase 1 Condition 3 (Prosocial Messaging, no Compensation)|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.
11355042|NCT03834025|EG003|Reported Event|Phase 1 Condition 4 (Prosocial Messaging, Compensation)|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.
11355043|NCT03834025|EG004|Reported Event|Phase 2 Condition 1 (no Compensation)|Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.
11355044|NCT03834025|EG005|Reported Event|Phase 2 Condition 2 (30% Compensation)|Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.
11355045|NCT03834025|EG006|Reported Event|Phase 2 Condition 3 (100% Compensation)|Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.
11355046|NCT03836677|BG000|Baseline|Overall Study|ITT Population
11355047|NCT03836677|FG000|Participant Flow|BGF MDI/GFF MDI|Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation followed by Washout and then Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
11355048|NCT03836677|FG001|Participant Flow|GFF MDI/BGF MDI|Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation followed by Washout and then Budesonide/Glycopyrronium/Formoterol Metered Dose Inhalation
11355049|NCT03836677|OG000|Outcome|BGF MDI|Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
11355050|NCT03836677|OG001|Outcome|GFF MDI|Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
11168754|NCT01987583|EG001|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
11355051|NCT03836677|EG000|Reported Event|BGF MDI|Budoesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
11355052|NCT03836677|EG001|Reported Event|GFF MDI|Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
11355053|NCT03836989|BG000|Baseline|High-volt Electrical Stimulation|"Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.~The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.~Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.~The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved"
11355054|NCT03836989|BG001|Baseline|Subsensory Electrical Stimulation|"Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.~The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting."
11355055|NCT03836989|BG002|Baseline|Total|Total of all reporting groups
11355056|NCT03836989|FG000|Participant Flow|High-volt Electrical Stimulation|"Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.~The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.~Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.~The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved."
11355057|NCT03836989|FG001|Participant Flow|Subsensory Electrical Stimulation|"Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.~The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting."
11357357|NCT03760913|OG009|Outcome|5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg
11357358|NCT03760913|OG010|Outcome|5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
11355058|NCT03836989|OG000|Outcome|High-volt Electrical Stimulation|"Plan to use a monophasic waveform having 100µmsec pulse duration, 35 Hz and using tolerated voltage for a total of 20 minutes. Electrical stimulation will be produced with the Orthostim 3 device. The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral arm.~The voltage is turned up by the participant until he or she can see twitches or as high as tolerated."
11355059|NCT03836989|OG001|Outcome|Subsensory Electrical Stimulation|"Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.~The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting."
11357359|NCT03760913|EG000|Reported Event|Placebo Part A, Single Ascending Dose|Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo
11357360|NCT03760913|EG001|Reported Event|30 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng
11168755|NCT01987596|BG000|Baseline|Arm I (Fixed Flexible Filgrastim Schedule)|"Period 1 Fixed: Patients receive filgrastim SC QD once daily started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.~Period 2 Flexible: Patients receive filgrastim:SC once starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)"
11168756|NCT01987596|BG001|Baseline|Arm II (Flexible Fixed Filgrastim Schedule)|"Period 1 Flexible: Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.~Period 2 Fixed: Patients receive filgrastim: given SC once daily starting on day 1 after chemotherapy in and daily thereafter until ANC reaches at least 1,000/uL post nadir."
11168757|NCT01987596|BG002|Baseline|Total|Total of all reporting groups
11168758|NCT01987596|FG000|Participant Flow|Arm I (Fixed Flexible Filgrastim Schedule)|"Period 1 Fixed: Patients receive filgrastim SC QD once daily started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.~Period 2 Flexible: Patients receive filgrastim:SC once starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)"
11168759|NCT01987596|FG001|Participant Flow|Arm II (Flexible Fixed Filgrastim Schedule)|"Period 1 Flexible: Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.~Period 2 Fixed: Patients receive filgrastim: given SC once daily starting on day 1 after chemotherapy in and daily thereafter until ANC reaches at least 1,000/uL post nadir."
11168760|NCT01987596|OG000|Outcome|Fixed|Mean of time to ANC1000 during period participants were on fixed regimen
11168761|NCT01987596|OG001|Outcome|Flexible|Mean of time to ANC1000 during period participants were on flexible regimen
11168762|NCT01987596|OG000|Outcome|Fixed|Incidence duriing time patient was on fixed schedule
11168763|NCT01987596|OG001|Outcome|Flexible|Incidence duriing time patient was on flexible schedule
11357361|NCT03760913|EG002|Reported Event|120 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng
11168764|NCT01987596|OG000|Outcome|Fixed Filgrastim|Patients receive filgrastim daily SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
11168765|NCT01987596|OG001|Outcome|Flexible Filgrastim|Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
11168766|NCT01987596|OG000|Outcome|Arm I (Fixed Filgrastim)|Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and continued daily until ANC reaches at least 1,000/uL post nadir.
11168767|NCT01987596|OG001|Outcome|Arm II (Flexible Filgrastim)|Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
11168768|NCT01987596|EG000|Reported Event|Arm I (Fixed Filgrastim)|"Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.~filgrastim: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)"
11168769|NCT01987596|EG001|Reported Event|Arm II (Flexible Filgrastim)|"Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.~filgrastim: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)"
11168770|NCT01987609|BG000|Baseline|All Participants|Each participant had 1 arm randomized to receive Hylenex, and the other hand randomized to receive Normal Saline.
11168771|NCT01987609|FG000|Participant Flow|All Study Participants|"Psoriatic plaques in one arm of each study participant will be injected with Hylenex every week for 4 weeks.~Psoriatic plaques on the opposite arm of each study participant will be injected with sterile normal saline every week for 4 weeks."
11168772|NCT01987609|OG000|Outcome|Hylenex|"Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks.~Hylenex"
11168773|NCT01987609|OG001|Outcome|Normal Saline|"Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks~Normal Saline"
11168774|NCT01987609|OG000|Outcome|Hylenex|"Psoriatic plaques in this arm of each study participant will be injected with Hylenex every week for 4 weeks.~Hylenex"
11357362|NCT03760913|EG003|Reported Event|400 ng OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng
11357363|NCT03760913|EG004|Reported Event|1.2 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg
11232483|NCT02418949|FG001|Participant Flow|Placebo for Cyproheptadine + Stretching|"Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.~Dose will be titrated down to zero in the 2 weeks following treatment.~Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed."
11232484|NCT02418949|FG002|Participant Flow|Cyproheptadine + Stretching|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.~Dose will be titrated down to zero in the 2 weeks following treatment.~Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed."
11232485|NCT02418949|FG003|Participant Flow|Placebo for Cyproheptadine + AMP|"Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.~Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy."
11232486|NCT02418949|OG000|Outcome|Cyproheptadine + AMP|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.~Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy."
11232487|NCT02418949|OG001|Outcome|Placebo for Cyproheptadine + Stretching|"Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.~Dose will be titrated down to zero in the 2 weeks following treatment.~Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed."
11233972|NCT02431637|OG000|Outcome|Piperaquine Phosphate After Infected Blood Malaria Challenge|"Volunteers will receive a dose of 480 mg piperaquine phosphate (PQP) approx. 7 days after a challenge with P. falciparum infected red blood cells. The effects of PQP on gametocyte carriage (assessed by PCR) and infectivity to mosquitos after direct and indirect feeding on blood from volunteers will be assessed.~Administration of the malaria inoculum: Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL.~Piperaquine Phosphate 480 mg: When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate."
11232488|NCT02418949|OG002|Outcome|Cyproheptadine + Stretching|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.~Dose will be titrated down to zero in the 2 weeks following treatment.~Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed."
11232489|NCT02418949|OG003|Outcome|Placebo for Cyproheptadine + AMP|"Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.~Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy."
11232490|NCT02418949|EG000|Reported Event|Cyproheptadine + AMP|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.~Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy."
11232491|NCT02418949|EG001|Reported Event|Placebo for Cyproheptadine + Stretching|"Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.~Dose will be titrated down to zero in the 2 weeks following treatment.~Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed."
11232492|NCT02418949|EG002|Reported Event|Cyproheptadine + Stretching|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.~Dose will be titrated down to zero in the 2 weeks following treatment.~Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed."
11233973|NCT02431637|EG000|Reported Event|Piperaquine Phosphate After Infected Blood Malaria Challenge|"Volunteers will receive a dose of 480 mg piperaquine phosphate (PQP) approx. 7 days after a challenge with P. falciparum infected red blood cells. The effects of PQP on gametocyte carriage (assessed by PCR) and infectivity to mosquitos after direct and indirect feeding on blood from volunteers will be assessed.~Administration of the malaria inoculum: Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL.~Piperaquine Phosphate 480 mg: When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate."
11168775|NCT01987609|OG000|Outcome|Psoriatic Plaques Injected With Hylenex|PGA score of psoriatic plaques on the arm of each study participant that is injected with Hylenex once a week for 4 weeks, at 3 weeks
11168776|NCT01987609|OG001|Outcome|Psoriatic Plaques Injected With Normal Saline|PGA score of psoriatic plaques on the arm of each study participant that is injected with normal saline once a week for 4 weeks, at 3 weeks.
11168777|NCT01987609|OG000|Outcome|Psoriatic Plaques Injected With Hylenex|PGA score of psoriatic plaques on the arm of each study participant that is injected with Hylenex once a week for 4 weeks, at 2 weeks.
11168778|NCT01987609|OG001|Outcome|Psoriatic Plaques Injected With Normal Saline|PGA score of psoriatic plaques on the arm of each study participant that is injected with normal saline once a week for 4 weeks, at 2 weeks.
11168779|NCT01987609|OG000|Outcome|Psoriatic Plaques Injected With Hylenex|PGA score of psoriatic plaques on the arm of each study participant that is injected with Hylenex once a week for 4 weeks, at 1 week.
11168780|NCT01987609|OG001|Outcome|Psoriatic Plaques Injected With Normal Saline|PGA score of psoriatic plaques on the arm of each study participant that is injected with normal saline once a week for 4 weeks, at 1 week.
11168781|NCT01987609|OG000|Outcome|All Participants|Histologic analysis was not done given that no significant difference was observed in primary endpoint of clinical improvement at interim analysis.
11168782|NCT01987609|EG000|Reported Event|Hylenex|"Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks.~Hylenex"
11168783|NCT01987609|EG001|Reported Event|Normal Saline|"Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks~Normal Saline"
11168784|NCT01987752|BG000|Baseline|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
11168785|NCT01987752|FG000|Participant Flow|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
11168786|NCT01987752|OG000|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
11168787|NCT01987752|EG000|Reported Event|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
11357364|NCT03760913|EG005|Reported Event|3 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg
11168788|NCT01987765|BG000|Baseline|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
11168789|NCT01987765|FG000|Participant Flow|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
11168790|NCT01987765|OG000|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
11168791|NCT01987765|EG000|Reported Event|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
11168792|NCT01987817|BG000|Baseline|AR101 Powder Provided in Capsules|"Study product provided as peanut protein in pull-apart capsules~AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol"
11168793|NCT01987817|BG001|Baseline|Placebo Powder Provided in Capsules|"Placebo formulation in pull-apart capsules containing only inactive ingredients~Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol"
11168794|NCT01987817|BG002|Baseline|Total|Total of all reporting groups
11168795|NCT01987817|FG000|Participant Flow|AR101 Powder Provided in Capsules|"Study product provided as peanut protein in pull-apart capsules~AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol"
11168796|NCT01987817|FG001|Participant Flow|Placebo Powder Provided in Capsules|"Placebo formulation in pull-apart capsules containing only inactive ingredients~Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol"
11168797|NCT01987817|OG000|Outcome|AR101 Powder Provided in Capsules|"Study product provided as peanut protein in pull-apart capsules~AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol"
11168798|NCT01987817|OG001|Outcome|Placebo Powder Provided in Capsules|"Placebo formulation in pull-apart capsules containing only inactive ingredients~Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol"
11168799|NCT01987817|OG000|Outcome|AR101 Powder Provided in Capsules|"Study product provided as peanut protein in pull-apart capsules.~AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol"
11168800|NCT01987817|EG000|Reported Event|AR101 Powder Provided in Capsules|"Study product provided as peanut protein in pull-apart capsules.~AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol"
11168801|NCT01987817|EG001|Reported Event|Placebo Powder Provided in Capsules|"Placebo formulation in pull-apart capsules containing only inactive ingredients~Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol"
11168802|NCT01987830|BG000|Baseline|TMZ-PET Scans/ MRI-PET Scan|"The investigators plan to study patients with recurrent glioblastoma whose clinical care plan includes treatment with bevacizumab and temozolomide. Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab (baseline- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples will be collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow.~In addition, we will explore the link between flow, permeability, and tumor temozolomide retention. These studies will be performed using our human simultaneous MRI-PET imaging camera.~MRI-PET: - [11C] temozolomide for PET scan and"
11232493|NCT02418949|EG003|Reported Event|Placebo for Cyproheptadine + AMP|"Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.~Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug~Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy."
11232494|NCT02419001|BG000|Baseline|Low Dose|1 g ceftriaxone and two low doses of SYN-004
11232495|NCT02419001|BG001|Baseline|High Dose|1 g ceftriaxone and two high doses of SYN-004
11232496|NCT02419001|BG002|Baseline|Total|Total of all reporting groups
11232497|NCT02419001|FG000|Participant Flow|Low Dose|1 g ceftriaxone and two low doses (75 mg) of SYN-004
11232498|NCT02419001|FG001|Participant Flow|High Dose|1 g ceftriaxone and two high doses (150 mg) of SYN-004
11232499|NCT02419001|OG000|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
11232500|NCT02419001|OG001|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
11232501|NCT02419001|EG000|Reported Event|Low Dose|1 g ceftriaxone and two low doses of SYN-004
11232502|NCT02419001|EG001|Reported Event|High Dose|1 g ceftriaxone and two high doses of SYN-004
11232503|NCT02419313|BG000|Baseline|All Study Participants|All participants included in this crossover design.
11232504|NCT02419313|FG000|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Subjects will all receive injections with saline first. At 12 weeks, these subjects will then cross over and receive Xeomin in the same distribution as their second treatment.
11232505|NCT02419313|FG001|Participant Flow|Incobotulinumtoxin A First, Then Placebo|Subjects will all receive injections with incobotulinumtoxinA injections first. At 12 weeks, these subjects will then cross over and receive placebo in the same distribution as their second treatment.
11232506|NCT02419313|OG000|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
11232507|NCT02419313|OG001|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
11232508|NCT02419313|EG000|Reported Event|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
11232509|NCT02419313|EG001|Reported Event|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
11232510|NCT02419469|BG000|Baseline|Ofatumumab Plus Chemotherapy|Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.
11232511|NCT02419469|FG000|Participant Flow|Ofatumumab Plus Chemotherapy|Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.
11232512|NCT02419469|OG000|Outcome|Ofatumumab Plus Chemotherapy|Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.
11232513|NCT02419469|EG000|Reported Event|Ofatumumab Plus Chemotherapy|Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.
11357365|NCT03760913|EG006|Reported Event|6 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg
11232514|NCT02419508|BG000|Baseline|SIMBRINZA + PGA|Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
11232515|NCT02419508|BG001|Baseline|Vehicle + PGA|Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
11232516|NCT02419508|BG002|Baseline|Total|Total of all reporting groups
11232517|NCT02419508|FG000|Participant Flow|SIMBRINZA + PGA|Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
11232518|NCT02419508|FG001|Participant Flow|Vehicle + PGA|Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
11232519|NCT02419508|OG000|Outcome|SIMBRINZA + PGA|Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
11232520|NCT02419508|OG001|Outcome|Vehicle + PGA|Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
11232521|NCT02419508|EG000|Reported Event|SIMBRINZA + PGA|Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
11232522|NCT02419508|EG001|Reported Event|Vehicle + PGA|Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
11232523|NCT02419521|BG000|Baseline|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
11232524|NCT02419521|FG000|Participant Flow|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
11232525|NCT02419521|OG000|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
11232526|NCT02419521|EG000|Reported Event|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
11232527|NCT02419547|BG000|Baseline|Anesthesia Induction|"Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).~Versed: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia~Fentanyl: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia~Propofol: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia~Sevoflurane: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia"
11232528|NCT02419547|FG000|Participant Flow|Anesthesia Induction|"Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).~Versed: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia~Fentanyl: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia~Propofol: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia~Sevoflurane: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia"
11232529|NCT02419547|OG000|Outcome|Ventriuclar Tachycardia Induction|"Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).~Versed: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia~Fentanyl: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia~Propofol: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia~Sevoflurane: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia"
11232530|NCT02419547|EG000|Reported Event|Anesthesia Induction|"Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).~Versed: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia~Fentanyl: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia~Propofol: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia~Sevoflurane: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia"
11232531|NCT02419573|BG000|Baseline|Endotracheal Intubation|"The insertion of a plastic breathing tube through the mouth and into the trachea.~Endotracheal Intubation: In this traditional model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use ETI as the primary (initial) airway management intervention. If the EMS agency is assigned to this arm, basic-level EMS personnel will use bag-valve-mask ventilation only even if they would normally use an LT."
11232532|NCT02419573|BG001|Baseline|Laryngeal Tube (King)|"Insertion of a supraglottic airway (SGA)~Laryngeal Tube (King): In this test model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use LT as the primary (initial) airway management intervention. Basic-level EMS personnel will use bag-valve-mask ventilation. If trained to use LT, basic-level EMS personnel may perform LT insertion."
11232533|NCT02419573|BG002|Baseline|Total|Total of all reporting groups
11357366|NCT03760913|EG007|Reported Event|12 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg
11232534|NCT02419573|FG000|Participant Flow|Endotracheal Intubation|"The insertion of a plastic breathing tube through the mouth and into the trachea.~Endotracheal Intubation: In this traditional model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use ETI as the primary (initial) airway management intervention. If the EMS agency is assigned to this arm, basic-level EMS personnel will use bag-valve-mask ventilation only even if they would normally use an LT."
11232535|NCT02419573|FG001|Participant Flow|Laryngeal Tube (King)|"Insertion of a supraglottic airway (SGA)~Laryngeal Tube (King): In this test model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use LT as the primary (initial) airway management intervention. Basic-level EMS personnel will use bag-valve-mask ventilation. If trained to use LT, basic-level EMS personnel may perform LT insertion."
11232536|NCT02419573|OG000|Outcome|Endotracheal Intubation|"The insertion of a plastic breathing tube through the mouth and into the trachea.~Endotracheal Intubation: In this traditional model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use ETI as the primary (initial) airway management intervention. If the EMS agency is assigned to this arm, basic-level EMS personnel will use bag-valve-mask ventilation only even if they would normally use an LT."
11232537|NCT02419573|OG001|Outcome|Laryngeal Tube (King)|"Insertion of a supraglottic airway (SGA)~Laryngeal Tube (King): In this test model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use LT as the primary (initial) airway management intervention. Basic-level EMS personnel will use bag-valve-mask ventilation. If trained to use LT, basic-level EMS personnel may perform LT insertion."
11232538|NCT02419573|EG000|Reported Event|Endotracheal Intubation|"The insertion of a plastic breathing tube through the mouth and into the trachea.~Endotracheal Intubation: In this traditional model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use ETI as the primary (initial) airway management intervention. If the EMS agency is assigned to this arm, basic-level EMS personnel will use bag-valve-mask ventilation only even if they would normally use an LT."
11232539|NCT02419573|EG001|Reported Event|Laryngeal Tube (King)|"Insertion of a supraglottic airway (SGA)~Laryngeal Tube (King): In this test model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use LT as the primary (initial) airway management intervention. Basic-level EMS personnel will use bag-valve-mask ventilation. If trained to use LT, basic-level EMS personnel may perform LT insertion."
11232540|NCT02419612|BG000|Baseline|Dapagliflozin 10mg and Saxagliptin 5mg|Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
11232541|NCT02419612|BG001|Baseline|Titrated Glimepiride|Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.
11232542|NCT02419612|BG002|Baseline|Total|Total of all reporting groups
11232543|NCT02419612|FG000|Participant Flow|Dapagliflozin 10mg and Saxagliptin 5mg|Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
11232544|NCT02419612|FG001|Participant Flow|Titrated Glimepiride|Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.
11232545|NCT02419612|OG000|Outcome|Dapagliflozin 10mg and Saxagliptin 5mg|Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
11232546|NCT02419612|OG001|Outcome|Titrated Glimepiride|Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.
11232547|NCT02419612|EG000|Reported Event|Dapagliflozin 10mg and Saxagliptin 5mg|Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
11232548|NCT02419612|EG001|Reported Event|Titrated Glimepiride|Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.
11232549|NCT02419690|BG000|Baseline|Usual Care|The current standard of care in the clinic is a preventive care physical examination every 1-2 years and/or treatment for presenting medical conditions. The frequency and content of reproductive health is not standardized between clinicians, but it is expected that all clinicians will address sexuality during routine visits. Additionally, sexually active teens are encouraged to have urine screening tests for chlamydia, gonorrhea and pregnancy as indicated. Teens may also see a reproductive health educator at the clinic as well. Available contraceptive methods are oral contraceptive pills, contraceptive patches, Depo-Provera, diaphragms, condoms, implants and intrauterine devices (IUDs).
11232550|NCT02419690|BG001|Baseline|Text Message Intervention|"Subjects in the intervention arm will receive usual care plus text messages that have been developed to promote overall teen sexual health.~text message intervention: Subjects will be sent 58 messages (3-5 per week) over 12 weeks, plus reminder messages for follow up interviews. The content of these messages will focus on contraception methods and effectiveness, sexually transmitted infection (STI) transmission, condom use, partner and parental communication, and healthy relationships. There will also be several text messages asking the participant if they would like to have a health educator contact them. The format will include facts, quizzes, true/false and some will have links to videos/pictures and websites, and some will request a response."
11232551|NCT02419690|BG002|Baseline|Total|Total of all reporting groups
11335574|NCT03552757|FG002|Participant Flow|Placebo|Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11357367|NCT03760913|EG008|Reported Event|20 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg
11168803|NCT01987830|FG000|Participant Flow|TMZ-PET Scans/ MRI-PET Scan|"Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab (baseline- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples were collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow."
11168804|NCT01987830|OG000|Outcome|TMZ-PET Scans/ MRI-PET Scan|"Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab (baseline- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples were collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow."
11168805|NCT01987830|EG000|Reported Event|TMZ-PET Scans/ MRI-PET Scan|"Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab (baseline- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples were collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow."
11168806|NCT01987895|BG000|Baseline|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
11168807|NCT01987895|BG001|Baseline|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
11168808|NCT01987895|BG002|Baseline|Total|Total of all reporting groups
11168809|NCT01987895|FG000|Participant Flow|Cadazolid|Subjects with Clostridium difficile-associated diarrhea (CDAD) received oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times a day (qid) for 10 days. Subjects were followed up for 30 days after the last dose of cadazolid. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 day of cadazolid + 30-day follow up)
11168810|NCT01987895|FG001|Participant Flow|Vancomycin|Subjects with CDAD received oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days. Subjects were followed up for 30 day after the last dose of vancomycin. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 day of cadazolid + 30-day follow up)
11168811|NCT01987895|OG000|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
11168812|NCT01987895|OG001|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
11168813|NCT01987895|EG000|Reported Event|Cadazolid|304 subjects received at least one dose of cadazolid and were included in the safety analysis. The median duration of treatment with cadazolid was 10 days.
11168814|NCT01987895|EG001|Reported Event|Vancomycin|322 subjects received at least one dose of vancomycin and were included in the safety analysis. The median duration of treatment with vancomycin was 10 days.
11168815|NCT01987908|BG000|Baseline|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
11168816|NCT01987908|FG000|Participant Flow|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
11168817|NCT01987908|FG001|Participant Flow|Treatment With Study Product|After placebo lead-in period, participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days during the double-blind treatment period
11168818|NCT01987908|FG002|Participant Flow|Treatment With Placebo|After placebo lead-in period, participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days during the double-blind treatment period
11168819|NCT01987908|OG000|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
11168820|NCT01987908|OG001|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
11168821|NCT01987908|OG002|Outcome|All Treated Participants|All participants randomized 3:1 (Aes-103 to placebo) and received 4 times daily dosing of 1,000 mg AEs-103 or 1,000 mg of placebo for 28 days
11168822|NCT01987908|OG000|Outcome|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
11168823|NCT01987908|OG000|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
11168824|NCT01987908|OG001|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no placebo was received
11168825|NCT01987908|OG002|Outcome|All Participants in Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received
11168826|NCT01987908|OG000|Outcome|Placebo Lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
11168827|NCT01987908|OG001|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
11168828|NCT01987908|OG002|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
11168829|NCT01987908|OG003|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
11168830|NCT01987908|OG004|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no placebo was received
11168831|NCT01987908|OG000|Outcome|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo (Day -14 to Day -1)
11168832|NCT01987908|OG001|Outcome|Double-blind Treatment Period - Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days (Day 1 to Day 28)
11168833|NCT01987908|OG002|Outcome|Double-blind Treatment Period - Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of placebo for 28 days (Day 1 to Day 28)
11168834|NCT01987908|OG003|Outcome|Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received (Day 29 to Day 49)
11168835|NCT01987908|OG000|Outcome|Overall Study Arm|Data not collected
11168836|NCT01987908|OG001|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
11168837|NCT01987908|OG000|Outcome|Overall Study Arm|
11168838|NCT01987908|EG000|Reported Event|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo (Day -14 to Day -1)
11168839|NCT01987908|EG001|Reported Event|Double-blind Treatment Period|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of either 1,000 mg of Aes-103 (study product) or placebo for 28 days (Day 1 to Day 28)
11168840|NCT01987908|EG002|Reported Event|Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received (Day 29 to Day 49)
11168841|NCT01987960|BG000|Baseline|Period 2 Placebo and PAR/SER (Randomized Period)|"Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
11168842|NCT01987960|BG001|Baseline|Period 2 Brexpiprazole and PAR/SER (Randomized Period)|"Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
11168843|NCT01987960|BG002|Baseline|Total|Total of all reporting groups
11168844|NCT01987960|FG000|Participant Flow|Period 1 Placebo and PAR/SER|"Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER).~Placebo: Once daily, tablets, orally"
11168845|NCT01987960|FG001|Participant Flow|Period 2 Placebo and PAR/SER (Randomized Period)|"Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
11168846|NCT01987960|FG002|Participant Flow|Period 2 Brexpiprazole and PAR/SER (Randomized Period)|"Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
11168847|NCT01987960|FG003|Participant Flow|Period 3 Placebo and PAR/SER|"Continuation of treatment with placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) from Period 1.~Placebo: Once daily, tablets, orally"
11168848|NCT01987960|OG000|Outcome|Period 2 Absolute Mean at Baseline; Placebo and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
11168849|NCT01987960|OG001|Outcome|Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
11168850|NCT01987960|OG002|Outcome|Period 2 Absolute Mean at Week 12; Placebo and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally~Absolute values at Week 12 in Period 2 (Study Week 24)"
11168851|NCT01987960|OG003|Outcome|Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally~Absolute values at Week 12 in Period 2 (Study Week 24)"
11168852|NCT01987960|OG002|Outcome|Period 2 Absolute Mean at Week 12; Placebo and PAR/SER|Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) Placebo: Once daily, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24); randomized period.
11168853|NCT01987960|OG003|Outcome|Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24)."
11168854|NCT01987960|EG000|Reported Event|Brexpiprazole + PAR/SER (Randomized Period)|
11168855|NCT01987960|EG001|Reported Event|Placebo + PAR/SER (Randomized Period)|
11168856|NCT01987986|BG000|Baseline|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168857|NCT01987986|BG001|Baseline|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11355060|NCT03836989|OG000|Outcome|High-volt Electrical Stimulation|"Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.~The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.~Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.~The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.~Electrical stimulation device (tens unit): An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory"
11355061|NCT03836989|OG001|Outcome|Subsensory Electrical Stimulation|"Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.~The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.~Electrical stimulation device (tens unit): An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory"
11355062|NCT03836989|OG000|Outcome|High-volt Electrical Stimulation|"Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.~The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.~Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.~The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved."
11355063|NCT03836989|EG000|Reported Event|High-volt Electric Stimulation|"Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.~The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.~Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.~The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved"
11355064|NCT03836989|EG001|Reported Event|Subsensory Electric Stimulation|"Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.~The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting."
11355065|NCT03827564|BG000|Baseline|ITN [TrueTear®] - Intranasal Application|Intranasal application of the ITN. Single application at application visit.
11355066|NCT03827564|BG001|Baseline|ITN [TrueTear®] - Extranasal Application|Extranasal application of the ITN. Single application at application visit.
11355067|NCT03827564|BG002|Baseline|Total|Total of all reporting groups
11355068|NCT03827564|FG000|Participant Flow|ITN [TrueTear®] - Intranasal Application|Intranasal application of the ITN. Single application at application visit.
11355069|NCT03827564|FG001|Participant Flow|ITN [TrueTear®] - Extranasal Application|Extranasal application of the ITN. Single application at application visit.
11355070|NCT03827564|OG000|Outcome|ITN [TrueTear®] - Intranasal Application|Intranasal application of the ITN. Single application at application visit.
11355071|NCT03827564|OG001|Outcome|ITN [TrueTear®] - Extranasal Application|Extranasal application of the ITN. Single application at application visit.
11355072|NCT03827564|EG000|Reported Event|ITN [TrueTear®] - Intranasal Application|Intranasal application of the ITN. Single application at application visit.
11355073|NCT03827564|EG001|Reported Event|ITN [TrueTear®] - Extranasal Application|Extranasal application of the ITN. Single application at application visit.
11355074|NCT03824236|BG000|Baseline|P-Fx Group|Healthy subjects, between and including 18 and 55 years of age, vaccinated with RTS,S/AS01 vaccine (different doses/formulations) and protected following the first challenge at the time of the MALARIA-092 study (NCT03162614), who received, in the current study, a fractional (Fx) booster dose of RTS,S/AS01E 12 months after completion of the vaccination course in the Malaria-092 study, and underwent sporozoite challenge.
11355075|NCT03824236|BG001|Baseline|NP-Fx Group|Healthy subjects, between and including 18 and 55 years of age, vaccinated with RTS,S/AS01 vaccine (different doses/formulations) and not protected following the first challenge at the time of the MALARIA-092 study (NCT03162614), who received, in the current study, a fractional (Fx) booster dose of RTS,S/AS01E 12 months after completion of the vaccination course in the Malaria-092 study, and underwent sporozoite challenge.
11355076|NCT03824236|BG002|Baseline|Infectivity Control Group|Healthy subjects, between and including 18 and 55 years of age, who did not receive, in the current study, any immunization but underwent sporozoite challenge.
11355077|NCT03824236|BG003|Baseline|Total|Total of all reporting groups
11355078|NCT03824236|FG000|Participant Flow|P-Fx Group|Healthy subjects, between and including 18 and 55 years of age, vaccinated with RTS,S/AS01 vaccine (different doses/formulations) and protected following the first challenge at the time of the MALARIA-092 study (NCT03162614), who received, in the current study, a fractional (Fx) booster dose of RTS,S/AS01E 12 months after completion of the vaccination course in the Malaria-092 study, and underwent sporozoite challenge.
11355079|NCT03824236|FG001|Participant Flow|NP-Fx Group|Healthy subjects, between and including 18 and 55 years of age, vaccinated with RTS,S/AS01 vaccine (different doses/formulations) and not protected following the first challenge at the time of the MALARIA-092 study (NCT03162614), who received, in the current study, a fractional (Fx) booster dose of RTS,S/AS01E 12 months after completion of the vaccination course in the Malaria-092 study, and underwent sporozoite challenge.
11355080|NCT03824236|FG002|Participant Flow|Infectivity Control Group|Healthy subjects, between and including 18 and 55 years of age, who did not receive, in the current study, any immunization but underwent sporozoite challenge.
11355081|NCT03824236|OG000|Outcome|P-Fx Group|Healthy subjects, between and including 18 and 55 years of age, vaccinated with RTS,S/AS01 vaccine (different doses/formulations) and protected following the first challenge at the time of the MALARIA-092 study (NCT03162614), who received, in the current study, a fractional (Fx) booster dose of RTS,S/AS01E 12 months after completion of the vaccination course in the Malaria-092 study, and underwent sporozoite challenge.
11355082|NCT03824236|OG001|Outcome|NP-Fx Group|Healthy subjects, between and including 18 and 55 years of age, vaccinated with RTS,S/AS01 vaccine (different doses/formulations) and not protected following the first challenge at the time of the MALARIA-092 study (NCT03162614), who received, in the current study, a fractional (Fx) booster dose of RTS,S/AS01E 12 months after completion of the vaccination course in the Malaria-092 study, and underwent sporozoite challenge.
11355083|NCT03824236|OG002|Outcome|Infectivity Control Group|Healthy subjects, between and including 18 and 55 years of age, who did not receive, in the current study, any immunization but underwent sporozoite challenge.
11355084|NCT03824236|EG000|Reported Event|P-Fx Group|Healthy subjects, between and including 18 and 55 years of age, vaccinated with RTS,S/AS01 vaccine (different doses/formulations) and protected following the first challenge at the time of the MALARIA-092 study (NCT03162614), who received, in the current study, a fractional (Fx) booster dose of RTS,S/AS01E 12 months after completion of the vaccination course in the Malaria-092 study, and underwent sporozoite challenge.
11355085|NCT03824236|EG001|Reported Event|NP-Fx Group|Healthy subjects, between and including 18 and 55 years of age, vaccinated with RTS,S/AS01 vaccine (different doses/formulations) and not protected following the first challenge at the time of the MALARIA-092 study (NCT03162614), who received, in the current study, a fractional (Fx) booster dose of RTS,S/AS01E 12 months after completion of the vaccination course in the Malaria-092 study, and underwent sporozoite challenge.
11355086|NCT03824236|EG002|Reported Event|Infectivity Control Group|Healthy subjects, between and including 18 and 55 years of age, who did not receive, in the current study, any immunization but underwent sporozoite challenge.
11355087|NCT03811951|BG000|Baseline|Novolin R First, Then Placebo|Participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in session 1. Then, participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in session 2.
11355088|NCT03811951|BG001|Baseline|Placebo First, Then Novolin R|Participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in session 1. Then, participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in session 2.
11355089|NCT03811951|BG002|Baseline|Total|Total of all reporting groups
11355090|NCT03811951|FG000|Participant Flow|Novolin R First, Then Placebo|Participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in session 1. Then, participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in session 2.
11355091|NCT03811951|FG001|Participant Flow|Placebo First, Then Novolin R|Participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in session 1. Then, participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in session 2.
11355092|NCT03811951|OG000|Outcome|Smokers|"All participants receive both Novolin R (experimental drug) and 14% NaCl (Sodium Chloride) solution (placebo), to be administered in randomly assigned order on two separate testing sessions. During administration of either Novolin R or 14% NaCl, participants will receive 1 spray in each nostril every 3 minutes for a total of 6 sprays. The nasal spray bottle delivers 0.1 ml of liquid per spray. Since the concentration of insulin in Novolin R is 100 IU/mL, six sprays will deliver a 60 IU dose.~Novolin R: Novolin R is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc chloride approximately 7 mcg/mL and water for injection. The pH (potential Hydrogen) is adjusted to 7.4. Hydrochloric acid 2N (concentration) or sodium hydroxide 2N may be added to adjust pH. Novolin R vials are latex-free. The drug substance is being purchased from McKesson."
11168858|NCT01987986|BG002|Baseline|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168859|NCT01987986|BG003|Baseline|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
11168860|NCT01987986|BG004|Baseline|Total|Total of all reporting groups
11168861|NCT01987986|FG000|Participant Flow|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168862|NCT01987986|FG001|Participant Flow|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168863|NCT01987986|FG002|Participant Flow|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168864|NCT01987986|FG003|Participant Flow|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
11168865|NCT01987986|OG000|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168866|NCT01987986|OG001|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168867|NCT01987986|OG002|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168868|NCT01987986|OG003|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
11168869|NCT01987986|EG000|Reported Event|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168870|NCT01987986|EG001|Reported Event|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168871|NCT01987986|EG002|Reported Event|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
11168872|NCT01987986|EG003|Reported Event|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
11168873|NCT01988012|BG000|Baseline|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators' discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
11168874|NCT01988012|FG000|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 milligram (mg) tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators' discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
11168875|NCT01988012|OG000|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators' discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
11168876|NCT01988012|EG000|Reported Event|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators' discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
11168877|NCT01988090|BG000|Baseline|High Dose Vitamin D ARM|"50,000 IU Vitamin D supplement~50,000 IU Vitamin D supplement: High Dose"
11168878|NCT01988090|BG001|Baseline|800 IU Vitamin D Supplement|"800 IU Vitamin D Supplement~800 IU Vitamin D Supplement: Standard Dose"
11168879|NCT01988090|BG002|Baseline|Total|Total of all reporting groups
11168880|NCT01988090|FG000|Participant Flow|High Dose Vitamin D ARM|"50,000 IU Vitamin D supplement~50,000 IU Vitamin D supplement: High Dose"
11168881|NCT01988090|FG001|Participant Flow|800 IU Vitamin D Supplement|"800 IU Vitamin D Supplement~800 IU Vitamin D Supplement: Standard Dose"
11168882|NCT01988090|OG000|Outcome|High Dose Vitamin D ARM|"50,000 IU Vitamin D supplement~50,000 IU Vitamin D supplement: High Dose"
11168883|NCT01988090|OG001|Outcome|800 IU Vitamin D Supplement|"800 IU Vitamin D Supplement~800 IU Vitamin D Supplement: Standard Dose"
11168884|NCT01988090|EG000|Reported Event|High Dose Vitamin D ARM|"50,000 IU Vitamin D supplement~50,000 IU Vitamin D supplement: High Dose"
11168885|NCT01988090|EG001|Reported Event|800 IU Vitamin D Supplement|"800 IU Vitamin D Supplement~800 IU Vitamin D Supplement: Standard Dose"
11168886|NCT01988103|BG000|Baseline|Placebo|Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
11168887|NCT01988103|BG001|Baseline|Apremilast 20 mg|Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
11168888|NCT01988103|BG002|Baseline|Apremilast 30 mg|Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
11168889|NCT01988103|BG003|Baseline|Total|Total of all reporting groups
11168890|NCT01988103|FG000|Participant Flow|Placebo|Participants who were initially randomized to identically matching placebo (PBO) by mouth (PO) twice a day (BID) during the Placebo-controlled Phase (Weeks 0-16).
11168891|NCT01988103|FG001|Participant Flow|Apremilast 20 mg|Participants were randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) and remained on apremilast 20 mg PO BID dosing during the active treatment phase (weeks 16-68).
11168892|NCT01988103|FG002|Participant Flow|Apremilast 30 mg|Participants were randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) and remained on apremilast 30 mg PO BID dosing during the active treatment phase (weeks 16-68).
11168893|NCT01988103|FG003|Participant Flow|Placebo-Apremilast 20 mg|Participants who were initially randomized to identically matching PBO PO BID during the Placebo-controlled Phase (weeks 0-16) were re-randomized to apremilast 20 mg PO BID and remained on apremilast 20 mg PO BID dosing during the active treatment phase (weeks 16-68).
11168894|NCT01988103|FG004|Participant Flow|Placebo-Apremilast 30 mg|Participants who were initially randomized to identically matching PBO PO BID during the Placebo-controlled Phase (weeks 0-16) were re-randomized to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (weeks 16-68).
11168895|NCT01988103|OG000|Outcome|Placebo|Participants initially randomized to identically matching placebo during the 16-week placebo controlled phase.
11168896|NCT01988103|OG001|Outcome|Apremilast 20mg|Participants initially randomized to apremilast 20mg BID during the 16-week placebo controlled phase.
11168897|NCT01988103|OG002|Outcome|Apremilast 30mg|Participants initially randomized to apremilast 30mg BID during the 16-week placebo controlled phase.
11168898|NCT01988103|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to apremilast 20mg PO BID during the 16-week placebo controlled phase.
11168899|NCT01988103|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to apremilast 30mg PO BID during the 16-week placebo controlled phase.
11168900|NCT01988103|OG000|Outcome|Placebo|Participants initially randomized to identically matching placebo PO BID during the 16-week placebo controlled phase.
11168901|NCT01988103|OG000|Outcome|Apremilast 20mg|Participants who received their first dose of apremilast 20 mg PO BID during the placebo-controlled phase or those who were originally randomized to placebo and were subsequently re-randomized to apremilast 20 mg PO BID.
11168902|NCT01988103|OG001|Outcome|Apremilast 30mg|Participants who received their first dose of apremilast 30 mg PO BID during the placebo-controlled phase or those who were originally randomized to placebo and were subsequently re-randomized to apremilast 30 mg PO BID.
11168903|NCT01988103|EG000|Reported Event|Placebo (Weeks 0-16)|Participants initially randomized to identically matching placebo (PBO) by mouth (PO) twice a day (BID) during the Placebo-controlled Phase (Weeks 0-16).
11168904|NCT01988103|EG001|Reported Event|Apremilast 20mg BID (Weeks 0-16)|Participants initially randomized to receive apremilast 20 mg BID PO during the Placebo-controlled Phase (Weeks 0-16).
11168905|NCT01988103|EG002|Reported Event|Apremilast 30mg BID (Weeks 0-16)|Participants initially randomized to apremilast 30 mg BID PO during the Placebo-controlled Phase (Weeks 0-16).
11168906|NCT01988103|EG003|Reported Event|Apremilast 20mg BID (Weeks 0-68)|Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 up until Week 68.
11168907|NCT01988103|EG004|Reported Event|Apremilast 30mg BID (Weeks 0-68)|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 up until Week 68
11168908|NCT01988129|BG000|Baseline|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
11168909|NCT01988129|BG001|Baseline|Control|Current practice
11168910|NCT01988129|BG002|Baseline|Total|Total of all reporting groups
11168911|NCT01988129|FG000|Participant Flow|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening.~32 stations were paired according to workload. One from each pair was randomized to receive the intervention program. Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related hazards and discussed the importance of sleep, and included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
11168912|NCT01988129|FG001|Participant Flow|Control|"Current practice.~Current practice. Firefighters in the Control Stations continued their normal role and were not invited to attend the sleep education and sleep disorders screening program. There was no formal contact with the control group.~As part of normal operational requirements, a small number of firefighters are reassigned to other stations each day and therefore 18/588 firefighters from control stations happened to be reassigned to an intervention station on the day of the education session and attended the session."
11357368|NCT03760913|EG009|Reported Event|40 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg
11357369|NCT03760913|EG010|Reported Event|80 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg
11089732|NCT01525082|BG000|Baseline|Bevacizumab + Capecitabine + Temozolomide|"Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.~Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14~Temozolomide: Temozolomide by mouth daily on Days 10 to 14~Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 & 15"
11089733|NCT01525082|FG000|Participant Flow|Bevacizumab + Capecitabine + Temozolomide|"Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal. Assessments for treatment effect are after every 3 cycles of treatment.~Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14~Temozolomide: Temozolomide by mouth daily on Days 10 to 14~Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 & 15"
11089734|NCT01525082|OG000|Outcome|Bevacizumab + Capecitabine + Temozolomide|"Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.~Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14~Temozolomide: Temozolomide by mouth daily on Days 10 to 14~Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 & 15"
11089735|NCT01525082|OG000|Outcome|Bevacizumab|Toxicities attributed to bevacizumab
11089736|NCT01525082|OG001|Outcome|Capecitabine|Toxicities attributed to capecitabine
11089737|NCT01525082|OG002|Outcome|Temozolomide|Toxicities attributed to temozolomide
11089738|NCT01525082|EG000|Reported Event|Bevacizumab + Capecitabine + Temozolomide|"Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.~Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14~Temozolomide: Temozolomide by mouth daily on Days 10 to 14~Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 & 15"
11089739|NCT01525173|BG000|Baseline|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
11089740|NCT01525173|BG001|Baseline|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
11089741|NCT01525173|BG002|Baseline|Total|Total of all reporting groups
11089742|NCT01525173|FG000|Participant Flow|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
11089743|NCT01525173|FG001|Participant Flow|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
11089744|NCT01525173|OG000|Outcome|ALPHAGAN® P and LUMIGAN®|1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
11089745|NCT01525173|OG001|Outcome|LUMIGAN® Alone|1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
11089746|NCT01525173|EG000|Reported Event|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
11089747|NCT01525173|EG001|Reported Event|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
11089748|NCT01525225|BG000|Baseline|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
11089749|NCT01525225|FG000|Participant Flow|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® immediate release (IR) tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
11089750|NCT01525225|OG000|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
11357370|NCT03760913|EG011|Reported Event|160 µg OLP-1002: Part A, Single Ascending Dose|OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg
11232552|NCT02419690|FG000|Participant Flow|Usual Care|The current standard of care in the clinic is a preventive care physical examination every 1-2 years and/or treatment for presenting medical conditions. The frequency and content of reproductive health is not standardized between clinicians, but it is expected that all clinicians will address sexuality during routine visits. Additionally, sexually active teens are encouraged to have urine screening tests for chlamydia, gonorrhea and pregnancy as indicated. Teens may also see a reproductive health educator at the clinic as well. Available contraceptive methods are oral contraceptive pills, contraceptive patches, Depo-Provera, diaphragms, condoms, implants and intrauterine devices (IUDs).
11232553|NCT02419690|FG001|Participant Flow|Text Message Intervention|"Subjects in the intervention arm will receive usual care plus text messages that have been developed to promote overall teen sexual health.~text message intervention: Subjects will be sent 58 messages (3-5 per week) over 12 weeks, plus reminder messages for follow up interviews. The content of these messages will focus on contraception methods and effectiveness, sexually transmitted infection (STI) transmission, condom use, partner and parental communication, and healthy relationships. There will also be several text messages asking the participant if they would like to have a health educator contact them. The format will include facts, quizzes, true/false and some will have links to videos/pictures and websites, and some will request a response."
11232554|NCT02419690|OG000|Outcome|Usual Care|The current standard of care in the clinic is a preventive care physical examination every 1-2 years and/or treatment for presenting medical conditions. The frequency and content of reproductive health is not standardized between clinicians, but it is expected that all clinicians will address sexuality during routine visits. Additionally, sexually active teens are encouraged to have urine screening tests for chlamydia, gonorrhea and pregnancy as indicated. Teens may also see a reproductive health educator at the clinic as well. Available contraceptive methods are oral contraceptive pills, contraceptive patches, Depo-Provera, diaphragms, condoms, implants and intrauterine devices (IUDs).
11232555|NCT02419690|OG001|Outcome|Text Message Intervention|"Subjects in the intervention arm will receive usual care plus text messages that have been developed to promote overall teen sexual health.~text message intervention: Subjects will be sent 58 messages (3-5 per week) over 12 weeks, plus reminder messages for follow up interviews. The content of these messages will focus on contraception methods and effectiveness, sexually transmitted infection (STI) transmission, condom use, partner and parental communication, and healthy relationships. There will also be several text messages asking the participant if they would like to have a health educator contact them. The format will include facts, quizzes, true/false and some will have links to videos/pictures and websites, and some will request a response."
11232556|NCT02419690|EG000|Reported Event|Usual Care|The current standard of care in the clinic is a preventive care physical examination every 1-2 years and/or treatment for presenting medical conditions. The frequency and content of reproductive health is not standardized between clinicians, but it is expected that all clinicians will address sexuality during routine visits. Additionally, sexually active teens are encouraged to have urine screening tests for chlamydia, gonorrhea and pregnancy as indicated. Teens may also see a reproductive health educator at the clinic as well. Available contraceptive methods are oral contraceptive pills, contraceptive patches, Depo-Provera, diaphragms, condoms, implants and intrauterine devices (IUDs).
11232557|NCT02419690|EG001|Reported Event|Text Message Intervention|"Subjects in the intervention arm will receive usual care plus text messages that have been developed to promote overall teen sexual health.~text message intervention: Subjects will be sent 58 messages (3-5 per week) over 12 weeks, plus reminder messages for follow up interviews. The content of these messages will focus on contraception methods and effectiveness, sexually transmitted infection (STI) transmission, condom use, partner and parental communication, and healthy relationships. There will also be several text messages asking the participant if they would like to have a health educator contact them. The format will include facts, quizzes, true/false and some will have links to videos/pictures and websites, and some will request a response."
11232558|NCT02419755|BG000|Baseline|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
11232559|NCT02419755|BG001|Baseline|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
11232560|NCT02419755|BG002|Baseline|Total|Total of all reporting groups
11232561|NCT02419755|FG000|Participant Flow|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
11232562|NCT02419755|FG001|Participant Flow|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
11232563|NCT02419755|OG000|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
11232564|NCT02419755|OG001|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
11232565|NCT02419755|EG000|Reported Event|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
11357371|NCT03760913|EG012|Reported Event|5 x Placebo Part B, Multiple Ascending Dose|Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5
11355093|NCT03811951|OG001|Outcome|Non-Smokers|"All participants receive both Novolin R (experimental drug) and 14% NaCl solution (placebo), to be administered in randomly assigned order on two separate testing sessions. During administration of either Novolin R or 14% NaCl, participants will receive 1 spray in each nostril every 3 minutes for a total of 6 sprays. The nasal spray bottle delivers 0.1 ml of liquid per spray. Since the concentration of insulin in Novolin R is 100 IU/mL, six sprays will deliver a 60 IU dose.~Novolin R: Novolin R is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc chloride approximately 7 mcg/mL and water for injection. The pH (potential Hydrogen) is adjusted to 7.4. Hydrochloric acid 2N (concentration) or sodium hydroxide 2N may be added to adjust pH. Novolin R vials are latex-free. The drug substance is being purchased from McKesson."
11355094|NCT03811951|EG000|Reported Event|Novolin R (First Intervention)|Participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in first session.
11355095|NCT03811951|EG001|Reported Event|Placebo (First Intervention)|Participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in first session.
11355096|NCT03811951|EG002|Reported Event|Placebo (Second Intervention)|Participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in second session.
11355097|NCT03811951|EG003|Reported Event|Novolin R (Second Intervention)|Participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in second session.
11355098|NCT03810235|BG000|Baseline|Transdermal Lidocaine Patch|"Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.~Transdermal Lidocaine Patch: Transdermal Lidocaine Patch"
11355099|NCT03810235|BG001|Baseline|Transdermal Hydrocolloid Placebo Patch|"Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.~Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches"
11355100|NCT03810235|BG002|Baseline|Total|Total of all reporting groups
11355101|NCT03810235|FG000|Participant Flow|Transdermal Lidocaine Patch|"Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.~Transdermal Lidocaine Patch: Transdermal Lidocaine Patch"
11089751|NCT01525225|EG000|Reported Event|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
11355102|NCT03810235|FG001|Participant Flow|Transdermal Hydrocolloid Placebo Patch|"Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.~Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches"
11355103|NCT03810235|OG000|Outcome|Transdermal Lidocaine Patch|"Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.~Transdermal Lidocaine Patch: Transdermal Lidocaine Patch"
11089752|NCT01525238|BG000|Baseline|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
11355104|NCT03810235|OG001|Outcome|Transdermal Hydrocolloid Placebo Patch|"Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.~Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches."
11355105|NCT03810235|OG001|Outcome|Transdermal Hydrocolloid Placebo Patch|"Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.~Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches"
11355106|NCT03810235|EG000|Reported Event|Transdermal Lidocaine Patch|"Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.~Transdermal Lidocaine Patch: Transdermal Lidocaine Patch"
11355107|NCT03810235|EG001|Reported Event|Transdermal Hydrocolloid Placebo Patch|"Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.~Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches"
11355108|NCT03806556|BG000|Baseline|Tranexamic Acid|"Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).~Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria"
11355109|NCT03806556|BG001|Baseline|Placebo|"Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.~Normal saline: IV medication administered after patient meets inclusion/exclusion criteria"
11355110|NCT03806556|BG002|Baseline|Total|Total of all reporting groups
11355111|NCT03806556|FG000|Participant Flow|Tranexamic Acid|"Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).~Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria"
11355112|NCT03806556|FG001|Participant Flow|Placebo|"Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.~Normal saline: IV medication administered after patient meets inclusion/exclusion criteria"
11355113|NCT03806556|OG000|Outcome|Tranexamic Acid|"Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).~Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria"
11355114|NCT03806556|OG001|Outcome|Placebo|"Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.~Normal saline: IV medication administered after patient meets inclusion/exclusion criteria"
11355115|NCT03806556|OG000|Outcome|Overall Study|All patients assessed for eligibility as defined by diagnosis of hematologic or solid tumor malignancy and anticipated platelet counts ≤20,000/uL for ≥5 days
11355116|NCT03806556|EG000|Reported Event|Tranexamic Acid|"Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).~Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria"
11355117|NCT03806556|EG001|Reported Event|Placebo|"Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.~Normal saline: IV medication administered after patient meets inclusion/exclusion criteria"
11355118|NCT03836664|BG000|Baseline|Timolol Intervention (2 Hours), Followed by Placebo (2 Hours)|"Participants were randomized to either Timolol/placebo group or placebo/Timolol group.~Migraine 1: Participants were given 0.5% timolol ophthalmic solution to use after migraine onset. They will put 2 drops of the solution in each eye after migraine onset and again 2 hours later if needed or headache persists.~Timolol: Timolol is a clear solution supplied in a plastic ophthalmic dispenser~There was no washout period.~Migraine 2: Participants were given matching placebo (0.9% normal saline solution) to use after migraine onset. They put 2 drops of solution in each eye after migraine onset and then again 2 hours later if needed or if headache persisted.~Placebo: Placebo is normal saline solution supplied in container matched to Timolol container."
11355119|NCT03836664|BG001|Baseline|Placebo (2 Hours), Followed by Timolol Intervention (2 Hours)|"Participants were randomized to either Timolol/placebo group or placebo/Timolol group.~Migraine 1: Participants were given matching placebo (0.9% normal saline solution) to use after migraine onset. They put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.~Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.~There was no washout period.~Migraine 2: Participants were given 0.5% timolol ophthalmic solution to use after migraine onset. They put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.~Timolol: Timolol is a clear solution supplied in a plastic ophthalmic dispenser."
11355120|NCT03836664|BG002|Baseline|Total|Total of all reporting groups
11355121|NCT03836664|FG000|Participant Flow|Timolol Intervention (2hours), no Washout, Placebo (2 Hours)|"Participants were randomized to either Timolol/placebo group or placebo/Timolol group.~Migraine 1: Participants were given 0.5% timolol ophthalmic solution to use after migraine onset. They will put 2 drops of the solution in each eye after migraine onset and again 2 hours later if needed or headache persists.~Timolol: Timolol is a clear solution supplied in a plastic ophthalmic dispenser~There was no washout period.~Migraine 2: Participants were given matching placebo (0.9% normal saline solution) to use after migraine onset. They put 2 drops of solution in each eye after migraine onset and then again 2 hours later if needed or if headache persisted.~Placebo: Placebo is normal saline solution supplied in container matched to Timolol container."
11355122|NCT03836664|FG001|Participant Flow|Placebo (2 Hours), no Washout, Timolol (2 Hours)|"Participants were randomized to either Timolol/placebo group or placebo/Timolol group.~Migraine 1: Participants were given placebo (0.9% normal saline solution) to use after migraine onset. They put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.~Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.~There was no washout period.~Migraine 2: Participants were given 0.5% timolol ophthalmic solution to use after migraine onset. They put 2 drops of solution in each eye after migraine onset and then again 2 hours later if needed or if headache persisted.~Timolol: Timolol is a clear solution supplied in a plastic ophthalmic dispenser."
11355123|NCT03836664|OG000|Outcome|All Participants Post Timolol|"Participants given 0.5% timolol ophthalmic solution to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later.~Timolol: Timolol is a clear solution supplied in a plastic ophthalmic dispenser."
11174160|NCT02019927|EG002|Reported Event|Multiple Sclerosis|"Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11355124|NCT03836664|OG001|Outcome|All Participants Post Placebo|"Participants given matching placebo (0.9% normal saline solution) to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later.~Placebo: Placebo is normal saline solution supplied in container matched to Timolol container."
11357372|NCT03760913|EG013|Reported Event|5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg
11355125|NCT03836664|OG000|Outcome|Total Number of Adverse Events Post Timolol Intervention|"Participants given 0.5% timolol ophthalmic solution to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.~Timolol: Timolol is a clear solution supplied in a plastic ophthalmic dispenser."
11355126|NCT03836664|OG001|Outcome|Total Number of Adverse Events Post Placebo|"Participants given matching placebo (0.9% normal saline solution) to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.~Placebo: Placebo is normal saline solution supplied in container matched to Timolol container."
11355127|NCT03836664|OG000|Outcome|Number of Participants Satisfied Post Timolol Intervention|"Participants given 0.5% timolol ophthalmic solution to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.~Timolol: Timolol is a clear solution supplied in a plastic ophthalmic dispenser."
11355128|NCT03836664|OG001|Outcome|Number of Participants Satisfied Post Placebo|"Participants given matching placebo (0.9% normal saline solution) to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.~Placebo: Placebo is normal saline solution supplied in container matched to Timolol container."
11355129|NCT03836664|EG000|Reported Event|All Participants Post Timolol|"Participants will be given 0.5% timolol ophthalmic solution to use after migraine onset. Participants will put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or headache persists.~Timolol: Timolol is a clear solution supplied in a plastic ophthalmic dispenser."
11355130|NCT03836664|EG001|Reported Event|All Participants Post Placebo|"Participants will be given matching placebo (0.9% normal saline solution) to use after migraine onset. Participants will put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or headache persists.~Placebo: Placebo is normal saline solution that will be supplied in container matched to Timolol container."
11355131|NCT03832738|BG000|Baseline|JTE-451 200 mg Twice Daily|JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
11355132|NCT03832738|BG001|Baseline|JTE-451 400 mg Twice Daily|JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
11355133|NCT03832738|BG002|Baseline|Placebo Twice Daily|Placebo Tablets orally twice daily for 16 weeks
11355134|NCT03832738|BG003|Baseline|Total|Total of all reporting groups
11355135|NCT03832738|FG000|Participant Flow|JTE-451 200 mg Twice Daily|JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
11355136|NCT03832738|FG001|Participant Flow|JTE-451 400 mg Twice Daily|JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
11355137|NCT03832738|FG002|Participant Flow|Placebo Twice Daily|Placebo Tablets orally twice daily for 16 weeks
11355138|NCT03832738|OG000|Outcome|JTE-451 200 mg Twice Daily|JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
11355139|NCT03832738|OG001|Outcome|JTE-451 400 mg Twice Daily|JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
11355140|NCT03832738|OG002|Outcome|Placebo Twice Daily|Placebo Tablets orally twice daily for 16 weeks
11355141|NCT03832738|EG000|Reported Event|JTE-451 200 mg Twice Daily|JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
11355142|NCT03832738|EG001|Reported Event|JTE-451 400 mg Twice Daily|JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
11355143|NCT03832738|EG002|Reported Event|Placebo Twice Daily|Placebo Tablets orally twice daily for 16 weeks
11355144|NCT03823391|BG000|Baseline|Adalimumab|Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22.
11355145|NCT03823391|BG001|Baseline|ABBV-3373 Followed by Placebo|Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22.
11355146|NCT03823391|BG002|Baseline|Total|Total of all reporting groups
11355147|NCT03823391|FG000|Participant Flow|Adalimumab|Participants were administered placebo to ABBV-3373 by intravenous (IV) infusion and 80 mg adalimumab by subcutaneous injection every other week (EOW) for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22.
11355148|NCT03823391|FG001|Participant Flow|ABBV-3373 Followed by Placebo|Participants were administered 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22.
11355149|NCT03823391|OG000|Outcome|Adalimumab|Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.
11355150|NCT03823391|OG001|Outcome|ABBV-3373|Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
11355151|NCT03823391|EG000|Reported Event|Period 1: ABBV-3373|Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
11355152|NCT03823391|EG001|Reported Event|Period 1: Adalimumab|Participants received 80 mg adalimumab by subcutaneous injection EOW and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks.
11355153|NCT03823391|EG002|Reported Event|Period 2: ABBV-3773 / Placebo|Participants received placebo to adalimumab by subcutaneous injection EOW from Week 12 to Week 24.
11355154|NCT03823391|EG003|Reported Event|Period 2: Adalimumab / Adalimumab|Participants continued to receive 80 mg adalimumab by subcutaneous injection EOW from Week 12 to Week 24.
11232566|NCT02419755|EG001|Reported Event|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
11232571|NCT02419924|BG000|Baseline|Experimental|"Pelvic floor support device to treat refractory constipation.~the Bottom's Up: A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation."
11232572|NCT02419924|FG000|Participant Flow|Experimental|"Pelvic floor support device to treat refractory constipation.~the Bottom's Up: A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation."
11232573|NCT02419924|OG000|Outcome|Experimental|"Pelvic floor support device to treat refractory constipation.~the Bottom's Up: A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation."
11232574|NCT02419924|EG000|Reported Event|Experimental|"Pelvic floor support device to treat refractory constipation.~the Bottom's Up: A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation."
11232575|NCT02419937|BG000|Baseline|Tocilizumab|"Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.~Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)"
11232576|NCT02419937|BG001|Baseline|Placebo|"Blinded subjects will be randomized to placebo~Placebo: Saline injection"
11232577|NCT02419937|BG002|Baseline|Total|Total of all reporting groups
11232578|NCT02419937|FG000|Participant Flow|Tocilizumab|"Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.~Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)"
11232579|NCT02419937|FG001|Participant Flow|Placebo|"Blinded subjects will be randomized to placebo~Placebo: Saline injection"
11232580|NCT02419937|OG000|Outcome|Tocilizumab|"Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.~Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)"
11232581|NCT02419937|OG001|Outcome|Placebo|"Blinded subjects will be randomized to placebo~Placebo: Saline injection"
11232582|NCT02419937|EG000|Reported Event|Tocilizumab|"Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.~Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)"
11232583|NCT02419937|EG001|Reported Event|Placebo|"Blinded subjects will be randomized to placebo~Placebo: Saline injection"
11232584|NCT02420015|BG000|Baseline|iCOMMIT|"Components include:~mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.~pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)~4 sessions cognitive-behavioral smoking cessation counseling;~Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.~SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."
11232585|NCT02420015|BG001|Baseline|Control Group|"Components include:~pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)~4 sessions cognitive-behavioral smoking cessation counseling;"
11357373|NCT03760913|EG014|Reported Event|5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg
11232586|NCT02420015|BG002|Baseline|Total|Total of all reporting groups
11232587|NCT02420015|FG000|Participant Flow|iCOMMIT|"Components include:~mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.~pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)~4 sessions cognitive-behavioral smoking cessation counseling;~Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.~SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."
11357374|NCT03760913|EG015|Reported Event|5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg
11232588|NCT02420015|FG001|Participant Flow|Control Group|"Components include:~pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)~4 sessions cognitive-behavioral smoking cessation counseling;"
11232589|NCT02420015|OG000|Outcome|iCOMMIT|"Components include:~mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.~pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)~4 sessions cognitive-behavioral smoking cessation counseling;~Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.~SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."
11232590|NCT02420015|OG001|Outcome|Control Group|"Components include:~pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)~4 sessions cognitive-behavioral smoking cessation counseling;"
11232591|NCT02420015|EG000|Reported Event|iCOMMIT|"Components include:~mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.~pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)~4 sessions cognitive-behavioral smoking cessation counseling;~Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.~SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."
11232592|NCT02420015|EG001|Reported Event|Control Group|"Components include:~pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)~4 sessions cognitive-behavioral smoking cessation counseling;"
11232593|NCT02420041|BG000|Baseline|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
11232594|NCT02420041|BG001|Baseline|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
11232595|NCT02420041|BG002|Baseline|Total|Total of all reporting groups
11232596|NCT02420041|FG000|Participant Flow|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the sacroiliac joint (SIJ)~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
11232597|NCT02420041|FG001|Participant Flow|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
11232598|NCT02420041|OG000|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
11232599|NCT02420041|OG001|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
11232600|NCT02420041|EG000|Reported Event|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
11232601|NCT02420041|EG001|Reported Event|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
11233974|NCT02431650|BG000|Baseline|Primaquine 15mg|"Administration of Primaquine 15mg (control).~Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. When PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants of this arm will receive 15mg of Primaquine treatment as the control."
11357375|NCT03760913|EG016|Reported Event|5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg
11357376|NCT03760913|EG017|Reported Event|5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg
11355155|NCT03820258|BG000|Baseline|SOF/VEL/VOX FDC|Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to < 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.
11355156|NCT03820258|FG000|Participant Flow|SOF/VEL/VOX FDC|Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to < 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.
11355157|NCT03820258|OG000|Outcome|SOF/VEL/VOX FDC|Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to < 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.
11355158|NCT03820258|EG000|Reported Event|SOF/VEL/VOX FDC|Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to < 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.
11355159|NCT03819491|BG000|Baseline|CoQ10 Once Daily|"100 mg OD~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355160|NCT03819491|BG001|Baseline|CoQ10 Twice a Day|"100 mg BID~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355161|NCT03819491|BG002|Baseline|Total|Total of all reporting groups
11355162|NCT03819491|FG000|Participant Flow|CoQ10 Once Daily|"100 mg OD~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355163|NCT03819491|FG001|Participant Flow|CoQ10 Twice a Day|"100 mg BID~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355164|NCT03819491|OG000|Outcome|CoQ10 Once Daily|"100 mg OD~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355165|NCT03819491|OG001|Outcome|CoQ10 Twice a Day|"100 mg BID~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355166|NCT03819491|EG000|Reported Event|CoQ10 Once Daily After Randomization|"100 mg OD~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355167|NCT03819491|EG001|Reported Event|CoQ10 Twice a Day After Randomization|"100 mg BID~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355168|NCT03819491|EG002|Reported Event|CoQ10 Once Daily Before Randomization|"100 mg OD~COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®"
11355169|NCT03808298|BG000|Baseline|Treatment Sequence A and B and Either C or D|All participants received Treatment A and Treatment B and either Treatment C or Treatment D.
11355170|NCT03808298|FG000|Participant Flow|Treatment Sequence A and B and Either C or D|All participants received Treatment A and Treatment B and either Treatment C or Treatment D.
11355171|NCT03808298|OG000|Outcome|Dose Level B of Balovaptan|Participants received dose level of B balovaptan.
11355172|NCT03808298|OG001|Outcome|Placebo|Participants received placebo.
11355173|NCT03808298|OG000|Outcome|Dose Level B of Balovaptan|Participants received dose level B of balovaptan.
11355174|NCT03808298|OG000|Outcome|Dose Level A of Balovaptan|Participants received dose level A of balovaptan.
11355175|NCT03808298|OG001|Outcome|Dose Level B of Balovaptan|Participants received dose level B of balovaptan.
11355176|NCT03808298|OG002|Outcome|Placebo|Participants received placebo.
11355177|NCT03808298|OG000|Outcome|Placebo|Participants received placebo.
11355178|NCT03808298|OG001|Outcome|Dose Level A of Balovaptan|Participants received dose level A of balovaptan.
11355179|NCT03808298|OG002|Outcome|Dose Level B of Balovaptan|Participants received dose level B of balovaptan.
11355180|NCT03808298|OG000|Outcome|Dose Level A of Balovaptan|Participants received dose level A of Balovaptan
11355181|NCT03808298|OG000|Outcome|Dose Level A of Balovaptan|All participants received Treatment A and Treatment B and either Treatment C or Treatment D.
11355182|NCT03808298|OG000|Outcome|Dose Level A of Balovaptan|Participants received dose level A of balovaptan
11355183|NCT03808298|OG000|Outcome|Dose Level A of Balovaptan|Participants received dose Level A of balovaptan.
11355184|NCT03808298|OG001|Outcome|Dose Level B of Balovaptan|Participants received dose level B of Balovaptan.
11355185|NCT03808298|OG000|Outcome|Treatment C|Participants in Treatment C received 400 mg of Moxifloxacin on Day 2.
11355186|NCT03808298|OG001|Outcome|Treatment D|Participants in Treatment D received 400 mg of Moxifloxacin on Day 15.
11355187|NCT03808298|OG000|Outcome|Treatment C|Participants in Treatment C received 400 mg of moxifloxacin on Day 2.
11355188|NCT03808298|OG001|Outcome|Treatment D|Participants in Treatment D received 400 mg of moxifloxacin on Day 15.
11355189|NCT03808298|OG000|Outcome|Dose A of Balovaptan|Participants received dose A of Balovaptan.
11355190|NCT03808298|OG001|Outcome|Dose B of Balovaptan|Participants received dose B of balovaptan
11355191|NCT03808298|OG000|Outcome|Moxifloxacin|Participants received 400 mg of moxifloxacin
11355192|NCT03808298|OG000|Outcome|Treatment Sequence A and B and Either C or D|All participants received Treatment A and Treatment B and either Treatment C or Treatment D.
11355193|NCT03808298|EG000|Reported Event|Treatment A Dose Level A|Participants in treatment A received balovaptan at dose level A.
11355194|NCT03808298|EG001|Reported Event|Treatment B Dose Level B|Participants in treatment B received balovaptan at dose level B.
11168913|NCT01988129|OG000|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
11168914|NCT01988129|OG001|Outcome|Control|Current practice
11168915|NCT01988129|OG000|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
11168916|NCT01988129|OG001|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
11168917|NCT01988129|OG000|Outcome|Baseline (Intervention)|Firefighters in the intervention group who volunteered to complete the sleep disorders screening survey
11168918|NCT01988129|EG000|Reported Event|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, including strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey which used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. Those who screened positive for any sleep disorder were notified as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up. Of the 431 firefighters completed the sleep disorders screening survey, 416 were from the intervention stations."
11168919|NCT01988129|EG001|Reported Event|Control|A total of 15/588 firefighters in the control stations who were temporarily assigned to duty in the intervention stations on the day of the survey completed the screening survey. The remaining 573 firefighters did not complete the survey and therefore there are no adverse event data to report.
11168920|NCT01988246|BG000|Baseline|Sham Injection|"Patients will be sequentially randomized to treatment with a sham injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.~Sham: Sham injection. No actual injection. No medication is used."
11168921|NCT01988246|BG001|Baseline|Intravitreal Aflibercept Injection|"Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.~Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection."
11168922|NCT01988246|BG002|Baseline|Total|Total of all reporting groups
11168923|NCT01988246|FG000|Participant Flow|Sham Injection|"Patients will be sequentially randomized to treatment with a sham injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.~Sham: Sham injection. No actual injection. No medication is used."
11168924|NCT01988246|FG001|Participant Flow|Intravitreal Aflibercept Injection|"Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.~Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection."
11168925|NCT01988246|OG000|Outcome|Sham Injection|"Patients will be sequentially randomized to treatment with a sham injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.~Sham: Sham injection. No actual injection. No medication is used."
11168926|NCT01988246|OG001|Outcome|Intravitreal Aflibercept Injection|"Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.~Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection."
11174161|NCT02019927|EG003|Reported Event|Sham - Multiple Sclerosis|Sham treatment of decreased vision due to Multiple Sclerosis
11355195|NCT03808298|EG002|Reported Event|Treatment C Placebo + Moxifloxacin 400 mg Day 2|Participants in treatment C received placebo plus 400 mg of moxifloxacin on Day 2.
11355196|NCT03808298|EG003|Reported Event|Treatment D Placebo + Moxifloxacin 400 mg Day 15|Participants in treatment D received placebo plus 400 mg moxifloxacin on Day 15.
11355197|NCT03808298|EG004|Reported Event|All Participants|All participants received Treatment A and Treatment B and either Treatment C or Treatment D.
11355198|NCT03836729|BG000|Baseline|TAF/FTC Followed by TAF/FTC+GSK3640254|Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
11355199|NCT03836729|FG000|Participant Flow|TAF/FTC Followed by TAF/FTC+GSK3640254|Participants in Period 1 received 25 milligram (mg) of TAF and 200 mg of FTC once daily (QD) on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
11355200|NCT03836729|OG000|Outcome|TAF/FTC|Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
11355201|NCT03836729|OG000|Outcome|TAF/FTC+GSK3640254|In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
11355202|NCT03836729|OG001|Outcome|TAF/FTC+GSK3640254|In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
11355203|NCT03836729|OG000|Outcome|TAF/FTC+GSK3640254|In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
11355204|NCT03836729|EG000|Reported Event|TAF/FTC|Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
11355205|NCT03836729|EG001|Reported Event|TAF/FTC+GSK3640254|In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
11355206|NCT03835975|BG000|Baseline|Cohort A: 20vPnC|Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
11355207|NCT03835975|BG001|Baseline|Cohort A: 13vPnC|Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
11355208|NCT03835975|BG002|Baseline|Cohort B: 20vPnC|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11355209|NCT03835975|BG003|Baseline|Cohort B: PPSV23|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
11355210|NCT03835975|BG004|Baseline|Cohort C: 20vPnC|Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11355211|NCT03835975|BG005|Baseline|Total|Total of all reporting groups
11355212|NCT03835975|FG000|Participant Flow|Cohort A: 20vPnC|Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
11355213|NCT03835975|FG001|Participant Flow|Cohort A: 13vPnC|Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
11355214|NCT03835975|FG002|Participant Flow|Cohort B: 20vPnC|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11355215|NCT03835975|FG003|Participant Flow|Cohort B: PPSV23|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
11355216|NCT03835975|FG004|Participant Flow|Cohort C: 20vPnC|Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11355217|NCT03835975|OG000|Outcome|Cohort A: 20vPnC|Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
11355218|NCT03835975|OG001|Outcome|Cohort A: 13vPnC|Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
11355219|NCT03835975|OG002|Outcome|Cohort B: 20vPnC|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11355220|NCT03835975|OG003|Outcome|Cohort B: PPSV23|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
11355221|NCT03835975|OG004|Outcome|Cohort C: 20vPnC|Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11232602|NCT02420093|BG000|Baseline|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
11232603|NCT02420093|BG001|Baseline|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
11232604|NCT02420093|BG002|Baseline|Total|Total of all reporting groups
11232605|NCT02420093|FG000|Participant Flow|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
11232606|NCT02420093|FG001|Participant Flow|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
11232607|NCT02420093|OG000|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
11232608|NCT02420093|OG001|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
11232609|NCT02420093|EG000|Reported Event|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
11232610|NCT02420093|EG001|Reported Event|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
11232611|NCT02420210|BG000|Baseline|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11232612|NCT02420210|FG000|Participant Flow|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11232613|NCT02420210|OG000|Outcome|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11089753|NCT01525238|BG001|Baseline|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
11232614|NCT02420210|EG000|Reported Event|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11355222|NCT03835975|OG001|Outcome|Cohort B: 20vPnC|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11232615|NCT02420223|BG000|Baseline|Propranolol|"Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm.~Propranolol"
11232616|NCT02420223|BG001|Baseline|Control Arm|Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.
11232617|NCT02420223|BG002|Baseline|Total|Total of all reporting groups
11232618|NCT02420223|FG000|Participant Flow|Propranolol|"Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm.~Propranolol"
11232619|NCT02420223|FG001|Participant Flow|Control Arm|Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.
11232620|NCT02420223|OG000|Outcome|Propranolol|"Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm.~Propranolol"
11232621|NCT02420223|OG001|Outcome|Control Arm|Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.
11232622|NCT02420223|EG000|Reported Event|Propranolol|"Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm.~Propranolol"
11232623|NCT02420223|EG001|Reported Event|Control Arm|Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.
11232624|NCT02420262|BG000|Baseline|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
11232625|NCT02420262|BG001|Baseline|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
11232626|NCT02420262|BG002|Baseline|Total|Total of all reporting groups
11232627|NCT02420262|FG000|Participant Flow|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
11168927|NCT01988246|EG000|Reported Event|Sham Injection|"Patients will be sequentially randomized to treatment with a sham injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.~Sham: Sham injection. No actual injection. No medication is used."
11168928|NCT01988246|EG001|Reported Event|Intravitreal Aflibercept Injection|"Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.~Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection."
11168929|NCT01988376|BG000|Baseline|Women With Cervical Cancer Receive Surepath for Screening|"Women will receive Surepath as a tool for screening the recurrence of cervical cancer.~Surepath: A liquid-base method of Pap smear for screening the recurrence of cervical cancer"
11168930|NCT01988376|BG001|Baseline|Women Receive Conventional Pap Smear for Screening|"Women who will receive conventional Pap smear for screening~Conventional Pap smear: Conventional Pap smear"
11168931|NCT01988376|BG002|Baseline|Total|Total of all reporting groups
11168932|NCT01988376|FG000|Participant Flow|Women With Cervical Cancer Receive Surepath for Screening|"Women will receive Surepath as a tool for screening the recurrence of cervical cancer.~Surepath: A liquid-base method of Pap smear for screening the recurrence of cervical cancer"
11168933|NCT01988376|FG001|Participant Flow|Women Receive Conventional Pap Smear for Screening|"Women who will receive conventional Pap smear for screening~Conventional Pap smear: Conventional Pap smear"
11168934|NCT01988376|OG000|Outcome|Women Received Surepath for Screening|Women who received Surepath for screening the recurrence of cervical cancer.
11168935|NCT01988376|OG001|Outcome|Women Received Conventional Pap Smear for Screening|Women who received conventional Pap smear for screening the recurrence of cervical cancer.
11168936|NCT01988376|EG000|Reported Event|Women With Cervical Cancer Receive Surepath for Screening|"Women will receive Surepath as a tool for screening the recurrence of cervical cancer.~Surepath: A liquid-base method of Pap smear for screening the recurrence of cervical cancer"
11168937|NCT01988376|EG001|Reported Event|Women Receive Conventional Pap Smear for Screening|"Women who will receive conventional Pap smear for screening~Conventional Pap smear: Conventional Pap smear"
11168938|NCT01988402|BG000|Baseline|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
11168939|NCT01988402|BG001|Baseline|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
11168940|NCT01988402|BG002|Baseline|Total|Total of all reporting groups
11168941|NCT01988402|FG000|Participant Flow|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
11168942|NCT01988402|FG001|Participant Flow|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
11168943|NCT01988402|OG000|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
11168944|NCT01988402|OG001|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
11168945|NCT01988402|EG000|Reported Event|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
11168946|NCT01988402|EG001|Reported Event|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
11168947|NCT01988415|BG000|Baseline|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
11168948|NCT01988415|FG000|Participant Flow|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
11168949|NCT01988415|OG000|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
11168950|NCT01988415|OG001|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
11168951|NCT01988415|EG000|Reported Event|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
11168952|NCT01988415|EG001|Reported Event|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
11174162|NCT02019927|EG004|Reported Event|Ocular Trauma|"Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).~Transcorneal Electrical Stimulation: The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy."
11174163|NCT02019927|EG005|Reported Event|Sham - Ocular Trauma|Sham treatment of decreased vision due to ocular trauma
11168953|NCT01988662|BG000|Baseline|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
11168954|NCT01988662|BG001|Baseline|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
11168955|NCT01988662|BG002|Baseline|Total|Total of all reporting groups
11168956|NCT01988662|FG000|Participant Flow|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
11168957|NCT01988662|FG001|Participant Flow|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
11168958|NCT01988662|OG000|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
11168959|NCT01988662|OG001|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
11168960|NCT01988662|EG000|Reported Event|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
11168961|NCT01988662|EG001|Reported Event|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
11168962|NCT01988662|EG002|Reported Event|Total|
11168963|NCT01988779|BG000|Baseline|Oral Placebo With Nebulized Intranasal Levofloxacin|"Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days~oral levofloxacin~nebulized levofloxacin"
11168964|NCT01988779|BG001|Baseline|Oral Antibiotics With Nebulized Intranasal Placebo|"Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.~oral levofloxacin~nebulized levofloxacin"
11168965|NCT01988779|BG002|Baseline|Total|Total of all reporting groups
11168966|NCT01988779|FG000|Participant Flow|Oral Placebo With Nebulized Intranasal Levofloxacin|"Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days~oral levofloxacin~nebulized levofloxacin"
11168967|NCT01988779|FG001|Participant Flow|Oral Antibiotics With Nebulized Intranasal Placebo|"Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.~oral levofloxacin~nebulized levofloxacin"
11168968|NCT01988779|OG000|Outcome|Oral Placebo With Nebulized Intranasal Levofloxacin|"Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days~oral levofloxacin~nebulized levofloxacin"
11168969|NCT01988779|OG001|Outcome|Oral Antibiotics With Nebulized Intranasal Placebo|"Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.~oral levofloxacin~nebulized levofloxacin"
11168970|NCT01988779|EG000|Reported Event|Oral Placebo With Nebulized Intranasal Levofloxacin|"Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days~oral levofloxacin~nebulized levofloxacin"
11168971|NCT01988779|EG001|Reported Event|Oral Antibiotics With Nebulized Intranasal Placebo|"Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.~oral levofloxacin~nebulized levofloxacin"
11168972|NCT01988857|BG000|Baseline|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
11168973|NCT01988857|FG000|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
11168974|NCT01988857|OG000|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
11168975|NCT01988857|EG000|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
11168976|NCT01988922|BG000|Baseline|Ketamine Arm- *1/*1|"1.*1/*1- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
11168977|NCT01988922|BG001|Baseline|Ketamine Arm - *1/*6|"2. *1/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
11168978|NCT01988922|BG002|Baseline|Ketamine Arm - *6/*6|"3. *6/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
11168979|NCT01988922|BG003|Baseline|Total|Total of all reporting groups
11168980|NCT01988922|FG000|Participant Flow|Ketamine Arm- *1/*1|"1.*1/*1- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose"
11168981|NCT01988922|FG001|Participant Flow|Ketamine Arm - *1/*6|"2. *1/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose"
11168982|NCT01988922|FG002|Participant Flow|Ketamine Arm - *6/*6|"3. *6/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose"
11168983|NCT01988922|OG000|Outcome|R-ketamine *1/*1|
11168984|NCT01988922|OG001|Outcome|S-ketamine *1/*1|
11168985|NCT01988922|OG002|Outcome|R-ketamine *1/*6|
11168986|NCT01988922|OG003|Outcome|S-ketamine *1/*6|
11168987|NCT01988922|OG004|Outcome|R-ketamine *6/*6|
11168988|NCT01988922|OG005|Outcome|S-ketamine *6/*6|
11232628|NCT02420262|FG001|Participant Flow|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
11232629|NCT02420262|OG000|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
11232630|NCT02420262|OG001|Outcome|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
11232631|NCT02420262|EG000|Reported Event|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
11232632|NCT02420262|EG001|Reported Event|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
11232633|NCT02420327|BG000|Baseline|Healthy Adults|"All participants receive the following four interventions, on separate days, in a counterbalanced order:~placebo patch and placebo capsule~placebo patch and galantamine capsule~nicotine patch and placebo capsule~nicotine patch and galantamine capsule~Placebo patch & placebo capsule: On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule.~Placebo patch & galantamine capsule: On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.).~Nicotine patch & placebo capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule.~Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.)."
11232634|NCT02420327|FG000|Participant Flow|Healthy Adults|"All participants receive the following four interventions, on separate days, in a counterbalanced order:~placebo patch and placebo capsule~placebo patch and galantamine capsule~nicotine patch and placebo capsule~nicotine patch and galantamine capsule~Placebo patch & placebo capsule: On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule.~Placebo patch & galantamine capsule: On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.).~Nicotine patch & placebo capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule.~Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.)."
11232635|NCT02420327|OG000|Outcome|Placebo Patch and Placebo Capsule|"On the double-placebo test day, participants receive a placebo patch and a placebo capsule.~Placebo patch & placebo capsule: On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule."
11232636|NCT02420327|OG001|Outcome|Nicotine Patch and Placebo Capsule|"On the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule.~Nicotine patch & placebo capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule."
11232637|NCT02420327|OG002|Outcome|Placebo Patch and Galantamine Capsule|"On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine.~Placebo patch & galantamine capsule: On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.)."
11232638|NCT02420327|OG003|Outcome|Nicotine Patch and Galantamine Capsule|"On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine.~Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.)."
11357377|NCT03760913|EG018|Reported Event|5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose|OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
11168989|NCT01988922|EG000|Reported Event|Ketamine Arm- *1/*1|"1.*1/*1- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
11168990|NCT01988922|EG001|Reported Event|Ketamine Arm - *1/*6|"2. *1/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
11168991|NCT01988922|EG002|Reported Event|Ketamine Arm - *6/*6|"3. *6/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
11168992|NCT01989130|BG000|Baseline|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
11168993|NCT01989130|BG001|Baseline|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
11168994|NCT01989130|BG002|Baseline|Total|Total of all reporting groups
11168995|NCT01989130|FG000|Participant Flow|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
11168996|NCT01989130|FG001|Participant Flow|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
11168997|NCT01989130|OG000|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
11168998|NCT01989130|OG001|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
11168999|NCT01989130|EG000|Reported Event|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
11169000|NCT01989130|EG001|Reported Event|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
11169001|NCT01989156|BG000|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169002|NCT01989156|BG001|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169003|NCT01989156|BG002|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169004|NCT01989156|BG003|Baseline|Total|Total of all reporting groups
11169005|NCT01989156|FG000|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169006|NCT01989156|FG001|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169007|NCT01989156|FG002|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169008|NCT01989156|OG000|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169009|NCT01989156|OG001|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169010|NCT01989156|OG002|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169011|NCT01989156|EG000|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169012|NCT01989156|EG001|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169013|NCT01989156|EG002|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
11169014|NCT01989169|BG000|Baseline|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
11169015|NCT01989169|BG001|Baseline|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
11169016|NCT01989169|BG002|Baseline|Total|Total of all reporting groups
11169017|NCT01989169|FG000|Participant Flow|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
11169018|NCT01989169|FG001|Participant Flow|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
11169019|NCT01989169|OG000|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
11169020|NCT01989169|OG001|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
11169021|NCT01989169|EG000|Reported Event|Midazolam Alone|Administered as a single oral 20 mg dose on Day 1.
11169022|NCT01989169|EG001|Reported Event|Midazolam + SSP-004184SS|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
11169023|NCT01989195|BG000|Baseline|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
11169024|NCT01989195|FG000|Participant Flow|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
11174164|NCT02019940|BG000|Baseline|Riluzole Open Label|Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
11355223|NCT03835975|OG002|Outcome|Cohort C: 20vPnC|Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11355224|NCT03835975|EG000|Reported Event|Cohort A: 20vPnC|Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
11355225|NCT03835975|EG001|Reported Event|Cohort A: 13vPnC|Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
11355226|NCT03835975|EG002|Reported Event|Cohort B: 20vPnC|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11355227|NCT03835975|EG003|Reported Event|Cohort B: PPSV23|Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
11355228|NCT03835975|EG004|Reported Event|Cohort C: 20vPnC|Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
11355229|NCT03821259|BG000|Baseline|Older Adults With Mental Health History|Eligible participants, aged 65 and over in receipt of psychological treatment for PTSD, anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
11355230|NCT03821259|FG000|Participant Flow|Older Adults With Mental Health History|Eligible participants, aged 65 and over in receipt of psychological treatment for PTSD, anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
11355231|NCT03821259|OG000|Outcome|Older Adults With Mental Health History|Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
11355232|NCT03821259|EG000|Reported Event|Older Adults With Mental Health History|Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
11355233|NCT03803085|BG000|Baseline|Control Condition|"Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.~Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days."
11355234|NCT03803085|BG001|Baseline|Treatment Condition|"Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.~Experimental condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days."
11355235|NCT03803085|BG002|Baseline|Total|Total of all reporting groups
11355236|NCT03803085|FG000|Participant Flow|Control Condition|"Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.~Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days."
11355237|NCT03803085|FG001|Participant Flow|Treatment Condition|"Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.~Treatment condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days."
11355238|NCT03803085|OG000|Outcome|Control Condition|"Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.~Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days."
11355239|NCT03803085|OG001|Outcome|Treatment Condition|"Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.~Treatment condition: Participants in the experimental condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days."
11355240|NCT03803085|OG001|Outcome|Treatment Condition|"Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.~Treatment condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days."
11089754|NCT01525238|BG002|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
11232639|NCT02420327|EG000|Reported Event|Placebo Patch and Placebo Capsule|"On the double-placebo test day, participants receive a placebo patch and a placebo capsule.~Placebo patch & placebo capsule: On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule."
11232640|NCT02420327|EG001|Reported Event|Nicotine Patch and Placebo Capsule|"On the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule.~Nicotine patch & placebo capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule."
11232641|NCT02420327|EG002|Reported Event|Placebo Patch and Galantamine Capsule|"On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine.~Placebo patch & galantamine capsule: On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.)."
11232642|NCT02420327|EG003|Reported Event|Nicotine Patch and Galantamine Capsule|"On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine.~Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.)."
11232643|NCT02420353|BG000|Baseline|Somatropin|"Somatropin of rDNA origin~Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period."
11232644|NCT02420353|BG001|Baseline|Placebo|"A placebo vehicle that contains somatropin diluent but no active hormone.~Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period."
11232645|NCT02420353|BG002|Baseline|Total|Total of all reporting groups
11232646|NCT02420353|FG000|Participant Flow|Somatropin|"Somatropin of rDNA origin~Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period."
11232647|NCT02420353|FG001|Participant Flow|Placebo|"A placebo vehicle that contains somatropin diluent but no active hormone.~Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period."
11232648|NCT02420353|OG000|Outcome|Somatropin|"Somatropin of rDNA origin~Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period."
11232649|NCT02420353|OG001|Outcome|Placebo|"A placebo vehicle that contains somatropin diluent but no active hormone.~Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period."
11232650|NCT02420353|EG000|Reported Event|Somatropin|"Somatropin of rDNA origin~Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period."
11232651|NCT02420353|EG001|Reported Event|Placebo|"A placebo vehicle that contains somatropin diluent but no active hormone.~Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period."
11232652|NCT02420379|BG000|Baseline|Eteplirsen 30 mg/kg|Participants with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping received eteplirsen 30 milligram per kilogram (mg/kg) intravenous (IV) infusions, once weekly, for 96 weeks.
11232653|NCT02420379|BG001|Baseline|Control Group (Untreated) (Non-exon 51 Amenable Participants)|Participants with DMD not amenable to exon 51 skipping were observed for 96 weeks.
11232654|NCT02420379|BG002|Baseline|Total|Total of all reporting groups
11232655|NCT02420379|FG000|Participant Flow|Eteplirsen 30 mg/kg|Participants with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping received eteplirsen 30 milligram per kilogram (mg/kg) intravenous (IV) infusions, once weekly, for 96 weeks.
11232656|NCT02420379|FG001|Participant Flow|Control Group (Untreated) (Non-exon 51 Amenable Participants)|Participants with DMD not amenable to exon 51 skipping were observed for 96 weeks.
11357378|NCT03760796|BG000|Baseline|Corrie Digital Health Platform Group|"Receives the Corrie Digital Health intervention plus the standard of care~Corrie Digital Health platform: The Corrie Digital Health platform consists of the Corrie smartphone app for heart attack recovery which is paired with an Apple Watch and Bluetooth-enabled, iHealth blood pressure cuff."
11089755|NCT01525238|BG003|Baseline|Total|Total of all reporting groups
11169025|NCT01989195|OG000|Outcome|DEMRI CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~DEMRI - MAGNEVIST (GADOLINIUM)~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
11169026|NCT01989195|OG001|Outcome|INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI)|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~MEMRI- SeeMore~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR"
11169027|NCT01989195|OG000|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
11169028|NCT01989195|OG000|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI~Outcome measurement followed for both as all subjects received both MEMRI and DEMRI."
11169029|NCT01989195|EG000|Reported Event|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH CLINICAL MAGNEVIST (GADOLINIUM), ONE WITH EXPERIMENTAL SEEMORE (MANGANESE) REAGENT. ADVERSE EVENTS TRACKED FOR SEEMORE MRI.~- CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
11169030|NCT01989208|BG000|Baseline|Sugar Capsule|Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
11169031|NCT01989208|BG001|Baseline|SG1002|"200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)~SG1002: 200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.~Six normal healthy subject and six heart failure subjects will be randomized and given SG1002 throughout the trial period."
11169032|NCT01989208|BG002|Baseline|Total|Total of all reporting groups
11169033|NCT01989208|FG000|Participant Flow|Sugar Capsule|Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
11169034|NCT01989208|FG001|Participant Flow|SG1002|"200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)~SG1002: 200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days to six normal healthy subjects and six heart failure subjects."
11169035|NCT01989208|OG000|Outcome|Sugar Capsule|Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
11169036|NCT01989208|OG001|Outcome|SG1002|"200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)~SG1002: 200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.~Six normal healthy subject and six heart failure subjects will be randomized and given SG1002 throughout the trial period."
11169037|NCT01989208|OG000|Outcome|Baseline|Baseline levels of free hydrogen sulfide (H2S) were recorded in heart failure subjects.
11169038|NCT01989208|OG001|Outcome|200 mg SG1002|200 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
11169039|NCT01989208|OG002|Outcome|400 mg SG002|400 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
11169040|NCT01989208|OG003|Outcome|800 mg SG1002|800 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
11169041|NCT01989208|OG000|Outcome|Sugar Capsule: Day 0|Baseline BNP levels of the subjects receiving sugar capsules.
11169042|NCT01989208|OG001|Outcome|Sugar Capsules: Day 7|Baseline BNP levels of the subjects receiving sugar capsules for 7 days.
11169043|NCT01989208|OG002|Outcome|Sugar Capsules: Day 14|Baseline BNP levels of the subjects receiving sugar capsules for 14 days.
11169044|NCT01989208|OG003|Outcome|Sugar Capsules: Day 21|Baseline BNP levels of the subjects receiving sugar capsules for 21 days.
11169045|NCT01989208|OG004|Outcome|SG1002: Day 0|Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, prior to any drug administration.
11169046|NCT01989208|OG005|Outcome|SG1002: Day 7|Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days.
11169047|NCT01989208|OG006|Outcome|SG1002: Day 14|Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days, then 400 mg SG1002 BID for an additional 7 days.
11169048|NCT01989208|OG007|Outcome|SG1002: Day 21|Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days, then 400 mg SG1002 BID for an additional 7 days and then 800 mg SG1002 BID for an additional 7 days..
11169049|NCT01989208|EG000|Reported Event|Sugar Capsule|Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
11169050|NCT01989208|EG001|Reported Event|SG1002|"200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)~SG1002: 200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.~Six normal healthy subject and six heart failure subjects will be randomized and given placebo throughout the trial period."
11169051|NCT01989221|BG000|Baseline|Placebo Followed by Sancuso|Placebo - Control for 1 week followed by Sancuso® (3.1 mg/24 hours) for 2 weeks
11169052|NCT01989221|FG000|Participant Flow|Placebo Followed by Sancuso|Placebo at baseline for one week followed by Sancuso® (granisetron transdermal system) 3.1 mg/24 hours for two weeks
11169053|NCT01989221|OG000|Outcome|Placebo Followed by Sancuso|Placebo - Control followed by Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
11169054|NCT01989221|EG000|Reported Event|Sancuso|Sancuso (3.1mg/24 hours) for 2 weeks
11169055|NCT01989455|BG000|Baseline|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11355241|NCT03803085|EG000|Reported Event|Control Condition|"Participants only saw their own daily walking steps using the WeRun function in WeChat. They did not use WeChat to see other group members' daily steps and did not engage in social contact with their group members.~Control condition: Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days."
11355242|NCT03803085|EG001|Reported Event|Treatment Condition|"Participants saw their own and other group member's daily walking steps using the WeRun function in WeChat and they were able to contact the other members of their group using We Chat.~Treatment condition: Participants in the treatment condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days."
11355243|NCT03801473|BG000|Baseline|Robot Assisted Training (RAT)|RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities
11355244|NCT03801473|BG001|Baseline|Conventional Training (CT)|Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
11355245|NCT03801473|BG002|Baseline|Total|Total of all reporting groups
11355246|NCT03801473|FG000|Participant Flow|Robot Assisted Gait|robot assisted gait therapy: The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.
11355247|NCT03801473|FG001|Participant Flow|Conventional Rehabilitation|Conventional rehabilitation: Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
11355248|NCT03801473|OG000|Outcome|Robot Assisted Training (RAT)|RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities
11355249|NCT03801473|OG001|Outcome|Conventional Training (CT)|Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
11355250|NCT03801473|EG000|Reported Event|Robot Assisted Training (RAT)|RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities
11355251|NCT03801473|EG001|Reported Event|Conventional Training (CT)|Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
11355252|NCT03834168|BG000|Baseline|Lean|"Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).~standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days."
11355253|NCT03834168|BG001|Baseline|Obese|"Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).~standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days."
11355254|NCT03834168|BG002|Baseline|Total|Total of all reporting groups
11355255|NCT03834168|FG000|Participant Flow|Lean|"Healthy self-identified African-American and white male lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).~standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days."
11355256|NCT03834168|FG001|Participant Flow|Obese|"Healthy self-identified African-American and white male obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).~standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days."
11355257|NCT03834168|OG000|Outcome|Lean|"Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).~standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days."
11357379|NCT03760796|BG001|Baseline|Historical Comparison Group|Receives the standard of care
11357380|NCT03760796|BG002|Baseline|Total|Total of all reporting groups
11355258|NCT03834168|OG001|Outcome|Obese|"Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).~standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days."
11355259|NCT03834168|EG000|Reported Event|Lean|"Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).~standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days."
11355260|NCT03834168|EG001|Reported Event|Obese|"Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).~standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days."
11355261|NCT03828149|BG000|Baseline|Drug: OP0201 First, Then Placebo|"Participants first received 20mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design~Drug:OP0201: Drug: OP0201"
11355262|NCT03828149|BG001|Baseline|Drug: Placebo First, Then OP0201|"Participants first received 0 mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design~Drug: Placebo: Drug: Placebo"
11355263|NCT03828149|BG002|Baseline|Total|Total of all reporting groups
11355264|NCT03828149|FG000|Participant Flow|Drug: OP0201 First, Then Placebo|"Participants first received 20mg one time dose of OP0201, followed by a washout and then a single dose of Placebo, cross over design~Drug:OP0201: Drug: OP0201"
11355265|NCT03828149|FG001|Participant Flow|Drug: Placebo First, Then OP0201|"Participants first received 0 mg one time dose of Placebo, followed by a washout and then a single dose of OP0201, cross over design~Drug: Placebo: Drug: Placebo"
11355266|NCT03828149|OG000|Outcome|Drug: OP0201|"Participants received 20mg OP0201 one time dose at Day 1 or Day 8.~Drug:OP0201: Drug: OP0201"
11355267|NCT03828149|OG001|Outcome|Drug: Placebo|"Participants received 0 mg one time dose at Day 1 or Day 8.~Drug: Placebo: Drug: Placebo"
11355268|NCT03828149|EG000|Reported Event|OP0201|"Participants received OP0201 20mg one time dose at either Day 1 or Day 8.~Drug:OP0201: Drug: OP0201"
11355269|NCT03828149|EG001|Reported Event|Placebo|"Participants received Placebo 0 mg one time dose at either Day 1 or Day 8.~Drug: Placebo: Drug: Placebo"
11355270|NCT03835221|BG000|Baseline|Overall Study|Total Participants
11355271|NCT03835221|FG000|Participant Flow|Methafilcon A / Fanfilcon A Contact Lenses|"All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A contact lenses for four (4) weeks of daily wear.~methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses~fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses"
11355272|NCT03835221|OG000|Outcome|Methafilcon A|"All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.~methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses"
11355273|NCT03835221|OG000|Outcome|Fanfilcon A|"All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear.~fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses"
11355274|NCT03835221|EG000|Reported Event|Methafilcon A Toric Contact Lenses|"All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.~methafilcon A toric contact lenses: Bilateral daily wear of methafilcon A toric contact lenses"
11169056|NCT01989455|BG001|Baseline|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11355275|NCT03835221|EG001|Reported Event|Fanfilcon A Toric Contact Lenses|"All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.~fanfilcon A toric contact lenses: Bilateral daily wear of fanfilcon A toric contact lenses"
11355276|NCT03819634|BG000|Baseline|Lantern Infusion Set|"Multi-slitted lantern infusion set~Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump."
11355277|NCT03819634|FG000|Participant Flow|Lantern Infusion Set|"Multi-slitted lantern infusion set~Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump."
11355278|NCT03819634|OG000|Outcome|Lantern Infusion Set|"Multi-slitted lantern infusion set~Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump."
11169057|NCT01989455|BG002|Baseline|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11232657|NCT02420379|OG000|Outcome|Eteplirsen 30 mg/kg|Participants with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping received eteplirsen 30 milligram per kilogram (mg/kg) intravenous (IV) infusions, once weekly, for 96 weeks.
11232658|NCT02420379|OG001|Outcome|Control Group (Untreated) (Non-exon 51 Amenable Participants)|Participants with DMD not amenable to exon 51 skipping were observed for 96 weeks.
11232659|NCT02420379|EG000|Reported Event|Eteplirsen 30 mg/kg|Participants with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping received eteplirsen 30 milligram per kilogram (mg/kg) intravenous (IV) infusions, once weekly, for 96 weeks.
11232660|NCT02420379|EG001|Reported Event|Control Group (Untreated) (Non-exon 51 Amenable Participants)|Participants with DMD not amenable to exon 51 skipping were observed for 96 weeks.
11232661|NCT02420639|BG000|Baseline|Intervention|"The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III).~Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature."
11232662|NCT02420639|FG000|Participant Flow|Intervention|"The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III).~Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature."
11232663|NCT02420639|OG000|Outcome|Intervention|"The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III).~Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature."
11232664|NCT02420639|EG000|Reported Event|Intervention|"The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III).~Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature. Adverse events specifically monitored included the following: cardiac arrhythmias, severe bradycardia, myocardial infarction/reinfarction, dysphagia, odynophagia, aspiration pneumonia, nonaspiration pneumonia, reflux, esophageal injury, and esophagitis."
11232665|NCT02420691|BG000|Baseline|Study Participants|LEE011 will be taken orally, once a day for 21 consecutive days followed by a 7 day planned break. LEE011 will be dosed on a flat dosing scale of 600 mg/day, irrespective of size and weight.
11232666|NCT02420691|FG000|Participant Flow|Study Participants|LEE011 will be taken orally, once a day for 21 consecutive days followed by a 7 day planned break. LEE011 will be dosed on a flat dosing scale of 600 mg/day, irrespective of size and weight.
11232667|NCT02420691|OG000|Outcome|Study Participants|LEE011 will be taken orally, once a day for 21 consecutive days followed by a 7 day planned break. LEE011 will be dosed on a flat dosing scale of 600 mg/day, irrespective of size and weight.
11232668|NCT02420691|EG000|Reported Event|Study Participants|LEE011 will be taken orally, once a day for 21 consecutive days followed by a 7 day planned break. LEE011 will be dosed on a flat dosing scale of 600 mg/day, irrespective of size and weight.
11232669|NCT02420873|BG000|Baseline|Cohort 1: CD56 Expressing Hematological Malignancies|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232670|NCT02420873|BG001|Baseline|Cohort 2: Myelofibrosis|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232671|NCT02420873|BG002|Baseline|Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232672|NCT02420873|BG003|Baseline|Total|Total of all reporting groups
11232673|NCT02420873|FG000|Participant Flow|Cohort 1: CD56 Expressing Hematological Malignancies|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232674|NCT02420873|FG001|Participant Flow|Cohort 2: Myelofibrosis|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232675|NCT02420873|FG002|Participant Flow|Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232676|NCT02420873|OG000|Outcome|Cohort 1: CD56 Expressing Hematological Malignancies|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232677|NCT02420873|OG001|Outcome|Cohort 2: Myelofibrosis|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232678|NCT02420873|OG002|Outcome|Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232679|NCT02420873|EG000|Reported Event|Cohort 1: CD56 Expressing Hematological Malignancies|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232680|NCT02420873|EG001|Reported Event|Cohort 2: Myelofibrosis|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232681|NCT02420873|EG002|Reported Event|Cohort 3: Blastic Plasmacytoid Dendritic Cell Neoplasm|"Lorvotuzumab mertansine (IMGN901) administered intravenously at a dose of 100 mg/m2 on Day 1 and 8 of a 21-day cycle.~Lorvotuzumab Mertansine (IMGN901): 100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle."
11232682|NCT02420951|BG000|Baseline|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
11232683|NCT02420951|BG001|Baseline|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
11232684|NCT02420951|BG002|Baseline|Total|Total of all reporting groups
11232685|NCT02420951|FG000|Participant Flow|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
11232686|NCT02420951|FG001|Participant Flow|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
11232687|NCT02420951|OG000|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
11232688|NCT02420951|OG001|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
11232689|NCT02420951|EG000|Reported Event|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
11232690|NCT02420951|EG001|Reported Event|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
11232691|NCT02421055|BG000|Baseline|Roux-en-Y Gastric Bypass (RYGB)|"50 participants gave pre-operative serum samples prior to undergoing RYGB. 23 participants underwent RYGB and gave serum samples pre and 3-months post-operatively.~13 of these gave complete sample sets of serum, 24-hour urine and stool pre and 3-months post-operation."
11232692|NCT02421055|BG001|Baseline|Vertical Sleeve Gastrectomy (VSG)|"74 participants gave pre-operative serum samples prior to undergoing VSG. 26 participants underwent VSG and gave serum samples pre and 3-months post-operatively.~14 of these gave complete sample sets of serum, 24-hour urine and stool pre and 3-months post-operation."
11232693|NCT02421055|BG002|Baseline|Total|Total of all reporting groups
11232694|NCT02421055|FG000|Participant Flow|Pre-operative Only|Recruited patients that did not undergo RYGB or VSG procedures
11232695|NCT02421055|FG001|Participant Flow|Roux-en-Y Gastric Bypass (RYGB)|Participants who underwent RYGB procedure
11232696|NCT02421055|FG002|Participant Flow|Vertical Sleeve Gastrectomy (VSG)|Participants who underwent VSG procedure
11232697|NCT02421055|OG000|Outcome|Roux-en-Y Gastric Bypass|Participants who underwent Roux-en-Y Gastric Bypass
11232698|NCT02421055|OG001|Outcome|Vertical Sleeve Gastrectomy|Participants who underwent Vertical Sleeve Gastrectomy
11232699|NCT02421055|OG000|Outcome|Group 1|Roux-en-Y Gastric Bypass
11232700|NCT02421055|OG001|Outcome|Group 2|Vertical Sleeve Gastrectomy
11232701|NCT02421055|EG000|Reported Event|Pre-operative Samples Only|Recruited patients that did not undergo RYGB or VSG procedures
11232702|NCT02421055|EG001|Reported Event|Roux-en-Y Gastric Bypass|Participants who underwent RYGB
11232703|NCT02421055|EG002|Reported Event|Vertical Sleeve Gastrectomy|Participants who underwent VSG
11232704|NCT02421094|BG000|Baseline|GR-MD-02 8 mg/kg|"Active~GR-MD-02: GM-MD-02 active"
11232705|NCT02421094|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo"
11232706|NCT02421094|BG002|Baseline|Total|Total of all reporting groups
11232707|NCT02421094|FG000|Participant Flow|GR-MD-02 8 mg/kg|"Active~GR-MD-02: GM-MD-02 active"
11232708|NCT02421094|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
11232709|NCT02421094|OG000|Outcome|GR-MD-02 8 mg/kg|"Active~GR-MD-02: GM-MD-02 active"
11232710|NCT02421094|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo"
11232711|NCT02421094|EG000|Reported Event|GR-MD-02 8 mg/kg|"Active~GR-MD-02: GM-MD-02 active"
11232712|NCT02421094|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11232713|NCT02421120|BG000|Baseline|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
11232714|NCT02421120|FG000|Participant Flow|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
11232715|NCT02421120|OG000|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
11232716|NCT02421120|EG000|Reported Event|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
11232717|NCT02421146|BG000|Baseline|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11355279|NCT03819634|EG000|Reported Event|Lantern Infusion Set|"Multi-slitted lantern infusion set~Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump."
11089756|NCT01525238|FG000|Participant Flow|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
11232718|NCT02421146|BG001|Baseline|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232719|NCT02421146|BG002|Baseline|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232720|NCT02421146|BG003|Baseline|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232721|NCT02421146|BG004|Baseline|Total|Total of all reporting groups
11232722|NCT02421146|FG000|Participant Flow|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232723|NCT02421146|FG001|Participant Flow|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232724|NCT02421146|FG002|Participant Flow|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232725|NCT02421146|FG003|Participant Flow|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232726|NCT02421146|OG000|Outcome|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232727|NCT02421146|OG001|Outcome|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232728|NCT02421146|OG002|Outcome|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232729|NCT02421146|OG003|Outcome|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11335575|NCT03552757|OG000|Outcome|Semaglutide 2.4 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11355280|NCT03812679|BG000|Baseline|AMIA APD Solution Generation System|"A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.~AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD)."
11355281|NCT03812679|FG000|Participant Flow|AMIA APD Solution Generation System|"A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.~AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD)."
11355282|NCT03812679|OG000|Outcome|AMIA APD Solution Generation System|"A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.~AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD)."
11355283|NCT03812679|EG000|Reported Event|AMIA APD Solution Generation System|"A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.~AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD)."
11355284|NCT03809052|BG000|Baseline|A1 - 5 mg GB1211 Single Dose|"6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11169058|NCT01989455|BG003|Baseline|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11355285|NCT03809052|BG001|Baseline|A2 - 20 mg GB1211 Single Dose|"6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355286|NCT03809052|BG002|Baseline|A3 - 50 mg GB1211 Single Dose (Food Effect Cohort)|"6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11169059|NCT01989455|BG004|Baseline|Placebo|Single intravenous dose of placebo (normal saline solution).
11169060|NCT01989455|BG005|Baseline|Total|Total of all reporting groups
11169061|NCT01989455|FG000|Participant Flow|500 mg Deferiprone|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169062|NCT01989455|FG001|Participant Flow|1000 mg Deferiprone|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL), followed one week later by a single oral dose of 1000 mg deferiprone oral solution, 80 mg/mL
11169063|NCT01989455|FG002|Participant Flow|1500 mg Deferiprone|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169064|NCT01989455|FG003|Participant Flow|2000 mg Deferiprone|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169065|NCT01989455|FG004|Participant Flow|Placebo|Single intravenous dose of placebo (normal saline solution).
11169066|NCT01989455|OG000|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169067|NCT01989455|OG001|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169068|NCT01989455|OG002|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169069|NCT01989455|OG003|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169070|NCT01989455|OG004|Outcome|Placebo|Single intravenous dose of placebo (normal saline solution).
11169071|NCT01989455|OG000|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169072|NCT01989455|OG001|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
11089757|NCT01525238|FG001|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
11089758|NCT01525238|FG002|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
11089759|NCT01525238|OG000|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
11089760|NCT01525238|OG001|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
11089761|NCT01525238|OG002|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
11089762|NCT01525238|EG000|Reported Event|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
11089763|NCT01525238|EG001|Reported Event|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
11089764|NCT01525238|EG002|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
11089765|NCT01525407|BG000|Baseline|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant~Atorvastatin Calcium: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
11089766|NCT01525407|BG001|Baseline|Patients|Recipients of donor stem cells.
11089767|NCT01525407|BG002|Baseline|Total|Total of all reporting groups
11089768|NCT01525407|FG000|Participant Flow|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant~Atorvastatin Calcium: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
11089769|NCT01525407|FG001|Participant Flow|Patients|Recipients of donor stem cells.
11089770|NCT01525407|OG000|Outcome|Patients|Recipients of donor stem cells.
11089771|NCT01525407|OG000|Outcome|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant~Atorvastatin Calcium: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
11089772|NCT01525407|EG000|Reported Event|Patient Adverse Events|Recipient: SAEs and UPs (life-threatening or fatal) will be monitored and recorded from the time the recipient starts conditioning therapy through day 100 or discharge from the center, whichever occurs earlier.
11089773|NCT01525407|EG001|Reported Event|Donor Adverse Events|Donor: SAEs, AEs (≥ grade 2) and UPs will be monitored and recorded from the time the donor starts atorvastatin therapy through the time of discharge from the transplant center after donation of stem cells or 7 days after the discontinuation of the medication, whichever occurs earlier.
11089774|NCT01525420|BG000|Baseline|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
11089775|NCT01525420|BG001|Baseline|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): ACT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
11089776|NCT01525420|BG002|Baseline|Total|Total of all reporting groups
11089777|NCT01525420|FG000|Participant Flow|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT~This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
11089778|NCT01525420|FG001|Participant Flow|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT~This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
11089779|NCT01525420|OG000|Outcome|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT"
11089780|NCT01525420|OG001|Outcome|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT"
11089781|NCT01525420|EG000|Reported Event|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT"
11089782|NCT01525420|EG001|Reported Event|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT"
11089783|NCT01525550|BG000|Baseline|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
11089784|NCT01525550|BG001|Baseline|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
11089785|NCT01525550|BG002|Baseline|Total|Total of all reporting groups
11089786|NCT01525550|FG000|Participant Flow|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
11089787|NCT01525550|FG001|Participant Flow|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
11089788|NCT01525550|OG000|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
11089789|NCT01525550|OG001|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
11169073|NCT01989455|OG000|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
11355287|NCT03809052|BG003|Baseline|A4 - 100 mg GB1211 Single Dose|"6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355288|NCT03809052|BG004|Baseline|A5 - 200 mg GB1211 Single Dose|"6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355289|NCT03809052|BG005|Baseline|A6 - 50mg GB1211 Single Dose|"6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.~GB1211: Hard capsules for oral use"
11355290|NCT03809052|BG006|Baseline|A7 - 400 mg GB1211 Single Dose|"6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.~GB1211: Hard capsules for oral use"
11355291|NCT03809052|BG007|Baseline|Part A - Placebo for GB1211|"In Part A, 14 subjects will receive placebo in total.~Placebo: Hard capsules for oral use Placebo: Hard capsules for oral use"
11355292|NCT03809052|BG008|Baseline|B1 - GB1211 Multiple Ascending Doses, 50mg BID|"GB1211 50mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.~GB1211: Hard capsules for oral use"
11355293|NCT03809052|BG009|Baseline|B2 - GB1211 Multiple Ascending Doses, 100mg BID|"GB1211 100mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.~GB1211: Hard capsules for oral use"
11355294|NCT03809052|BG010|Baseline|Part B - Placebo for GB1211 (BID)|"In Part B, 6 subjects will receive placebo in total.~Placebo: Hard capsules for oral use~Placebo: Hard capsules for oral use"
11355295|NCT03809052|BG011|Baseline|Total|Total of all reporting groups
11355296|NCT03809052|FG000|Participant Flow|A1 - 5 mg GB1211 Single Dose|"6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355297|NCT03809052|FG001|Participant Flow|A2 - 20 mg GB1211 Single Dose|"6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355298|NCT03809052|FG002|Participant Flow|A3 - 50 mg GB1211 Single Dose (Food Effect Cohort)|"6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods.~GB1211: Hard capsules for oral use"
11355299|NCT03809052|FG003|Participant Flow|A4 - 100 mg GB1211 Single Dose|"6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355300|NCT03809052|FG004|Participant Flow|A5 - 200 mg GB1211 Single Dose|"6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355301|NCT03809052|FG005|Participant Flow|A6 - 50mg GB1211 Single Dose|"6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.~GB1211: Hard capsules for oral use"
11355302|NCT03809052|FG006|Participant Flow|A7 - 400 mg GB1211 Single Dose|"6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.~GB1211: Hard capsules for oral use"
11355303|NCT03809052|FG007|Participant Flow|Part A - Placebo GB1211|"In Part A, 14 subjects will receive placebo in total.~Placebo: Hard capsules for oral use"
11355304|NCT03809052|FG008|Participant Flow|B1 - GB1211 Multiple Ascending Doses, 50mg BID|"GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.~GB1211: Hard capsules for oral use"
11355305|NCT03809052|FG009|Participant Flow|B2 - GB1211 Multiple Ascending Doses, 100mg BID|"GB1211 100 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.~GB1211: Hard capsules for oral use"
11232730|NCT02421146|EG000|Reported Event|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232731|NCT02421146|EG001|Reported Event|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232732|NCT02421146|EG002|Reported Event|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232733|NCT02421146|EG003|Reported Event|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
11232734|NCT02421172|BG000|Baseline|Period 1: CJM112 High Dose|Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
11232735|NCT02421172|BG001|Baseline|Period 1: Placebo|Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
11232736|NCT02421172|BG002|Baseline|Total|Total of all reporting groups
11232737|NCT02421172|FG000|Participant Flow|Period 1: CJM112 High Dose|Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
11232738|NCT02421172|FG001|Participant Flow|Period 1: Placebo|Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
11232739|NCT02421172|FG002|Participant Flow|Extension Period 2: CJM112 High Dose /Placebo|Extension Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on CJM112 High Dose in Period 1
11232740|NCT02421172|FG003|Participant Flow|Extension Period 2: Placebo/CJM112 Low Dose|Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
11232741|NCT02421172|FG004|Participant Flow|Extension Period 2: Placebo/CJM112 High Dose|Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
11232742|NCT02421172|OG000|Outcome|Period 1: CJM112 High Dose|Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
11232743|NCT02421172|OG001|Outcome|Period 1: Placebo|Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
11232744|NCT02421172|OG001|Outcome|Extension Period 2: Placebo/CJM112 Low Dose|Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
11232745|NCT02421172|OG002|Outcome|Extension Period 2: Placebo/CJM112 High Dose|Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
11232746|NCT02421172|EG000|Reported Event|Period 1: CJM112 High Dose|Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
11232747|NCT02421172|EG001|Reported Event|Period 1: Placebo|Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
11232748|NCT02421172|EG002|Reported Event|Extension Period 2: CJM112 High Dose /Placebo|Extension Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on CJM112 High Dose in Period 1
11232749|NCT02421172|EG003|Reported Event|Extension Period 2: Placebo/CJM112 Low Dose|Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
11232750|NCT02421172|EG004|Reported Event|Extension Period 2: Placebo/CJM112 High Dose|Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
11232751|NCT02421211|BG000|Baseline|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
11232752|NCT02421211|BG001|Baseline|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
11232753|NCT02421211|BG002|Baseline|Total|Total of all reporting groups
11355306|NCT03809052|FG010|Participant Flow|Part B - PLacebo GB1211 (BID)|"In Part B, 6 subjects will receive placebo in total.~Placebo: Hard capsules for oral use"
11169074|NCT01989455|EG000|Reported Event|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169075|NCT01989455|EG001|Reported Event|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169076|NCT01989455|EG002|Reported Event|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169077|NCT01989455|EG003|Reported Event|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
11169078|NCT01989455|EG004|Reported Event|Placebo|Single intravenous dose of placebo (normal saline solution).
11169079|NCT01989455|EG005|Reported Event|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
11169080|NCT01989468|BG000|Baseline|AIN457 150 mg|1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169081|NCT01989468|BG001|Baseline|AIN457 300 mg|2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169082|NCT01989468|BG002|Baseline|Placebo|Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169083|NCT01989468|BG003|Baseline|Total|Total of all reporting groups
11169084|NCT01989468|FG000|Participant Flow|AIN457 150 mg|1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169085|NCT01989468|FG001|Participant Flow|AIN457 300 mg|2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169086|NCT01989468|FG002|Participant Flow|Placebo_AIN457 150 mg|Placebo switch to Secukinumab/AIN457 150 mg
11169087|NCT01989468|FG003|Participant Flow|Placebo_AIN457 300 mg|Placebo switch to Secukinumab/AIN457 300 mg
11169088|NCT01989468|FG004|Participant Flow|Placebo Not Rerandomized|Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169089|NCT01989468|OG000|Outcome|AIN457 150 mg|1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169090|NCT01989468|OG001|Outcome|AIN457 300 mg|2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169091|NCT01989468|OG002|Outcome|Placebo|Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169092|NCT01989468|OG000|Outcome|Any AIN457 150 mg|Any patients exposed to AIN457 150 mg
11169093|NCT01989468|OG001|Outcome|Any AIN457 300 mg|Any patients exposed to AIN457 300 mg
11169094|NCT01989468|OG002|Outcome|Any AIN457|Any patients exposed to AIN457
11169095|NCT01989468|OG003|Outcome|Placebo|Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169096|NCT01989468|EG000|Reported Event|Any AIN457 150 mg|1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169097|NCT01989468|EG001|Reported Event|Any AIN457 300 mg|2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169098|NCT01989468|EG002|Reported Event|Any AIN457|Any patients exposed to AIN457
11169099|NCT01989468|EG003|Reported Event|Placebo|Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
11169100|NCT01989546|BG000|Baseline|Talazoparib (BMN 673)|Single-agent BMN 673 (talazoparib) dosed orally at 1 mg/day in 28-day cycles. This poly (ADP-ribose) polymerase (PARP) inhibitor has been shown to cause single-agent synthetic lethality in breast cancer 1 and breast cancer 2 (BRCA1/2)- and phosphatase and tensin homolog (PTEN)-deficient cell lines, and has potent antitumor activity in animal models of tumors harboring mutations in deoxyribonucleic acid (DNA) repair pathways.
11169101|NCT01989546|FG000|Participant Flow|Talazoparib (BMN 673)|Single-agent BMN 673 (talazoparib) dosed orally at 1 mg/day in 28-day cycles. This poly (ADP-ribose) polymerase (PARP) inhibitor has been shown to cause single-agent synthetic lethality in breast cancer 1 and breast cancer 2 (BRCA1/2)- and phosphatase and tensin homolog (PTEN)-deficient cell lines, and has potent antitumor activity in animal models of tumors harboring mutations in deoxyribonucleic acid (DNA) repair pathways.
11169102|NCT01989546|OG000|Outcome|Talazoparib (BMN 673)|Single-agent BMN 673 (talazoparib) dosed orally at 1 mg/day in 28-day cycles. This poly (ADP-ribose) polymerase (PARP) inhibitor has been shown to cause single-agent synthetic lethality in breast cancer 1 and breast cancer 2 (BRCA1/2)- and phosphatase and tensin homolog (PTEN)-deficient cell lines, and has potent antitumor activity in animal models of tumors harboring mutations in deoxyribonucleic acid (DNA) repair pathways.
11169103|NCT01989546|EG000|Reported Event|Talazoparib (BMN 673)|Single-agent BMN 673 (talazoparib) dosed orally at 1 mg/day in 28-day cycles. This poly (ADP-ribose) polymerase (PARP) inhibitor has been shown to cause single-agent synthetic lethality in breast cancer 1 and breast cancer 2 (BRCA1/2)- and phosphatase and tensin homolog (PTEN)-deficient cell lines, and has potent antitumor activity in animal models of tumors harboring mutations in deoxyribonucleic acid (DNA) repair pathways.
11169104|NCT01989572|BG000|Baseline|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
11174165|NCT02019940|FG000|Participant Flow|Riluzole Open Label|Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
11355307|NCT03809052|OG000|Outcome|A1 - 5 mg GB1211 Single Dose|"6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355308|NCT03809052|OG001|Outcome|A2 - 20 mg GB1211 Single Dose|"6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355309|NCT03809052|OG002|Outcome|A3 - 50 mg GB1211 Single Dose (Food Effect Cohort)|"6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods.~GB1211: Hard capsules for oral use"
11355310|NCT03809052|OG003|Outcome|A4 - 100 mg GB1211 Single Dose|"6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355311|NCT03809052|OG004|Outcome|A5 - 200 mg GB1211 Single Dose|"6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355312|NCT03809052|OG005|Outcome|A6 - 50mg GB1211 Single Dose|"6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.~GB1211: Hard capsules for oral use"
11355313|NCT03809052|OG006|Outcome|A7 - 400 mg GB1211 Single Dose|"6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.~GB1211: Hard capsules for oral use"
11355314|NCT03809052|OG007|Outcome|Part A - Placebo for GB1211|"In Part A, 14 subjects will receive placebo in total.~Placebo: Hard capsules for oral use"
11355315|NCT03809052|OG008|Outcome|B1 - GB1211 Multiple Ascending Doses, 50mg BID|"GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.~GB1211: Hard capsules for oral use"
11355316|NCT03809052|OG009|Outcome|B2 - GB1211 Multiple Ascending Doses, 100mg BID|"GB1211 100 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.~GB1211: Hard capsules for oral use"
11355317|NCT03809052|OG010|Outcome|Part B - Placebo for GB1211 (BID)|"In Part B, 6 subjects will receive placebo in total.~Placebo: Hard capsules for oral use"
11355318|NCT03809052|EG000|Reported Event|Part A - Placebo for GB1211|"In Part A, 14 subjects will receive placebo in total.~Placebo: Hard capsules for oral use"
11355319|NCT03809052|EG001|Reported Event|Part A - Placebo GB1211 (Fed)|"In Part A, 2 subjects will receive placebo in total in a fed state.~Placebo: Hard capsules for oral use"
11355320|NCT03809052|EG002|Reported Event|A1 - 5 mg GB1211 Single Dose|"6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355321|NCT03809052|EG003|Reported Event|A2 - 20 mg GB1211 Single Dose|"6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355322|NCT03809052|EG004|Reported Event|"A3 - 50 mg GB1211 Single Dose (Period 1: Fasted) and A3- 50 mg GB1211 Single Dose (Period 2: Fed)"|"6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355323|NCT03809052|EG005|Reported Event|A6 - 50mg GB1211 Single Dose|"6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.~GB1211: Hard capsules for oral use"
11355324|NCT03809052|EG006|Reported Event|A3- 50 mg GB1211 Single Dose (Fed)|"6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.~GB1211: Hard capsules for oral use"
11355325|NCT03809052|EG007|Reported Event|A4 - 100 mg GB1211 Single Dose|"6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355326|NCT03809052|EG008|Reported Event|A5 - 200 mg GB1211 Single Dose|"6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11169105|NCT01989572|BG001|Baseline|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
11169106|NCT01989572|BG002|Baseline|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
11169107|NCT01989572|BG003|Baseline|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
11169108|NCT01989572|BG004|Baseline|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
11169109|NCT01989572|BG005|Baseline|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
11169110|NCT01989572|BG006|Baseline|Total|Total of all reporting groups
11169111|NCT01989572|FG000|Participant Flow|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
11169112|NCT01989572|FG001|Participant Flow|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
11169113|NCT01989572|FG002|Participant Flow|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
11169114|NCT01989572|FG003|Participant Flow|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
11169115|NCT01989572|FG004|Participant Flow|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
11169116|NCT01989572|FG005|Participant Flow|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
11169117|NCT01989572|OG000|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
11169118|NCT01989572|OG001|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
11169119|NCT01989572|OG000|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
11169120|NCT01989572|OG001|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
11169121|NCT01989572|OG000|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
11169122|NCT01989572|OG001|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
11169123|NCT01989572|OG002|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
11169124|NCT01989572|OG003|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
11169125|NCT01989572|OG004|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
11169126|NCT01989572|OG005|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
11169127|NCT01989572|EG000|Reported Event|Arm I (GM-CSF, Peptide Vaccine)|"Arm I (GM-CSF, peptide vaccine) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC peptide vaccine: Given SC"
11169128|NCT01989572|EG001|Reported Event|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Arm II (GM-CSF placebo, peptide vaccine) Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC GM-CSF placebo: Given SC"
11169129|NCT01989572|EG002|Reported Event|Arm III (GM-CSF, Peptide Placebo)|"Arm III (GM-CSF, peptide placebo) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC peptide placebo: Given SC"
11169130|NCT01989572|EG003|Reported Event|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Arm IV (GM-CSF placebo, peptide placebo) Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC peptide placebo: Given SC"
11355327|NCT03809052|EG009|Reported Event|A7 - 400 mg GB1211 Single Dose|"6 healthy subjects are administered 400 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.~GB1211: Hard capsules for oral use"
11355328|NCT03809052|EG010|Reported Event|Part B - Placebo for GB1211 (BID)|"In Part B, 6 subjects will receive placebo in total.~Placebo: Hard capsules for oral use"
11355329|NCT03809052|EG011|Reported Event|B1 - GB1211 Multiple Ascending Doses, 50mg BID|"GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.~GB1211: Hard capsules for oral use"
11355330|NCT03809052|EG012|Reported Event|B2 - GB1211 Multiple Ascending Doses, 100mg BID|"GB1211 100mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.~GB1211: Hard capsules for oral use"
11355331|NCT03801148|BG000|Baseline|Part 1: Dexlansoprazole 30 mg TOB + Dexlansoprazole 30 mg TPC|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5-day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
11355332|NCT03801148|BG001|Baseline|Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
11355333|NCT03801148|BG002|Baseline|Part 2: Dexlansoprazole 60 mg TOB + Dexlansoprazole 60 mg TPC|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
11355334|NCT03801148|BG003|Baseline|Part 2: Dexlansoprazole 60 mg TPC + Dexlansoprazole 60 mg TOB|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
11355335|NCT03801148|BG004|Baseline|Total|Total of all reporting groups
11355336|NCT03801148|FG000|Participant Flow|Part 1: Dexlansoprazole 30 mg TOB + Dexlansoprazole 30 mg TPC|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5-day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
11355337|NCT03801148|FG001|Participant Flow|Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
11355338|NCT03801148|FG002|Participant Flow|Part 2: Dexlansoprazole 60 mg TOB + Dexlansoprazole 60 mg TPC|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
11355339|NCT03801148|FG003|Participant Flow|Part 2: Dexlansoprazole 60 mg TPC + Dexlansoprazole 60 mg TOB|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
11169131|NCT01989572|EG004|Reported Event|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
11355340|NCT03801148|OG000|Outcome|Part 1: Dexlansoprazole 30 mg TOB|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.
11355341|NCT03801148|OG001|Outcome|Part 1: Dexlansoprazole 30 mg TPC|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.
11355342|NCT03801148|OG002|Outcome|Part 2: Dexlansoprazole 60 mg TOB|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.
11355343|NCT03801148|OG003|Outcome|Part 2: Dexlansoprazole 60 mg TPC|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.
11169132|NCT01989572|EG005|Reported Event|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
11174166|NCT02019940|OG000|Outcome|Riluzole Open Label|Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
11355344|NCT03801148|EG000|Reported Event|Part 1: Dexlansoprazole 30 mg TOB|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.
11355345|NCT03801148|EG001|Reported Event|Part 1: Dexlansoprazole 30 mg TPC|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.
11355346|NCT03801148|EG002|Reported Event|Part 2: Dexlansoprazole 60 mg TOB|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.
11355347|NCT03801148|EG003|Reported Event|Part 2: Dexlansoprazole 60 mg TPC|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.
11355348|NCT03832907|BG000|Baseline|Dexcom G6 CGM - Continues Glucose Monitoring Sensor System|Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.
11355349|NCT03832907|FG000|Participant Flow|Dexcom G6 CGM - Continues Glucose Monitoring Sensor System|Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.
11355350|NCT03832907|OG000|Outcome|Dexcom G6 CGM - Continues Glucose Monitoring Sensor System|"Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.~POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days."
11355351|NCT03832907|EG000|Reported Event|Dexcom G6 CGM - Continues Glucose Monitoring Sensor System|Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.
11355352|NCT03832322|BG000|Baseline|Water Exchange Colonoscopy|During the insertion phase of the first-pass colonoscopy, WE method was used. When the cecum was reached, CO2 was opened during the withdrawal phase of the first-pass colonoscopy. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11355353|NCT03832322|BG001|Baseline|CO2 Insufflation Colonoscopy|During the first-pass colonoscopy, the procedure was performed in the usual fashion, with minimal CO2 insufflation to aid insertion. Cleaning of colon was predominantly performed during withdrawal. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11355354|NCT03832322|BG002|Baseline|Total|Total of all reporting groups
11355355|NCT03832322|FG000|Participant Flow|Water Exchange Colonoscopy|During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, CO2 was opened during the withdrawal phase of the first-pass colonoscopy. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11355356|NCT03832322|FG001|Participant Flow|CO2 Insufflation Colonoscopy|During the first-pass colonoscopy, the procedure was performed in the usual fashion, with minimal CO2 insufflation to aid insertion. Cleaning of colon was predominantly performed during withdrawal. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11355357|NCT03832322|OG000|Outcome|CO2 Insufflation Colonoscopy|During the first-pass colonoscopy, the procedure was performed in the usual fashion, with minimal CO2 insufflation to aid insertion. Cleaning of colon was predominantly performed during withdrawal. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11174167|NCT02019940|EG000|Reported Event|Riluzole Open Label|Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
11355358|NCT03832322|OG001|Outcome|Water Exchange Colonoscopy|During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, CO2 was opened during the withdrawal phase of the first-pass colonoscopy. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11232754|NCT02421211|FG000|Participant Flow|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
11232755|NCT02421211|FG001|Participant Flow|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
11232756|NCT02421211|OG000|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
11232757|NCT02421211|OG001|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
11232758|NCT02421211|OG000|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
11232759|NCT02421211|OG001|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
11232760|NCT02421211|OG000|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
11232761|NCT02421211|OG001|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
11232762|NCT02421211|EG000|Reported Event|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
11232763|NCT02421211|EG001|Reported Event|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
11232764|NCT02421224|BG000|Baseline|Usual Care|"Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan."
11232765|NCT02421224|BG001|Baseline|Deposits|"Same as Usual Care, plus participants will have to deposit a certain amount of their own money as an incentive to quit smoking. Participants will be able to make additional voluntary deposits above the minimum amount. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test."
11232766|NCT02421224|BG002|Baseline|Small Individual Bonus|"Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test."
11232767|NCT02421224|BG003|Baseline|Large Individual Bonus|"Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group."
11233975|NCT02431650|BG001|Baseline|OZ439 500mg|"Administration of OZ439 500mg.~Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. When PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants will receive 500mg of OZ439."
11233976|NCT02431650|BG002|Baseline|Total|Total of all reporting groups
11232768|NCT02421224|BG004|Baseline|Team Bonus|"Same as Usual Care, plus each participant will be randomly assigned one teammate to provide social support during the quit attempt. If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.~Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group."
11232769|NCT02421224|BG005|Baseline|Deposits Plus Small Individual Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Small Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test."
11232770|NCT02421224|BG006|Baseline|Deposits Plus Large Individual Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Large Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group."
11232771|NCT02421224|BG007|Baseline|Deposits Plus Teammate|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will be randomly assigned one other participant to serve as a teammate who provides social support during the quit attempt.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant."
11232772|NCT02421224|BG008|Baseline|Deposits Plus Team Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group, will be randomly assigned a teammate, and will follow the protocol for the monetary bonus as described for the Team Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine test.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.~Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group."
11232773|NCT02421224|BG009|Baseline|Total|Total of all reporting groups
11232774|NCT02421224|FG000|Participant Flow|Usual Care|"Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan."
11232775|NCT02421224|FG001|Participant Flow|Deposits|"Same as Usual Care, plus participants will have to deposit a certain amount of their own money as an incentive to quit smoking. Participants will be able to make additional voluntary deposits above the minimum amount. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test."
11232776|NCT02421224|FG002|Participant Flow|Small Individual Bonus|"Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test."
11232777|NCT02421224|FG003|Participant Flow|Large Individual Bonus|"Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group."
11232778|NCT02421224|FG004|Participant Flow|Team Bonus|"Same as Usual Care, plus each participant will be randomly assigned one teammate to provide social support during the quit attempt. If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.~Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group."
11232779|NCT02421224|FG005|Participant Flow|Deposits Plus Small Individual Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Small Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test."
11232780|NCT02421224|FG006|Participant Flow|Deposits Plus Large Individual Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Large Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group."
11233977|NCT02431650|FG000|Participant Flow|Primaquine 15mg|"Administration of Primaquine 15mg (control).~Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. When PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants of this arm will receive 15mg of Primaquine treatment as the control."
11335576|NCT03552757|OG001|Outcome|Placebo|Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11232781|NCT02421224|FG007|Participant Flow|Deposits Plus Teammate|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will be randomly assigned one other participant to serve as a teammate who provides social support during the quit attempt.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant."
11232782|NCT02421224|FG008|Participant Flow|Deposits Plus Team Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group, will be randomly assigned a teammate, and will follow the protocol for the monetary bonus as described for the Team Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine test.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.~Team Bonus: If the participant and assigned teammate both quit smoking at 3 mos., as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group."
11232783|NCT02421224|OG000|Outcome|Usual Care|"Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan."
11232784|NCT02421224|OG001|Outcome|Deposits|"Same as Usual Care, plus participants will have to deposit a certain amount of their own money as an incentive to quit smoking. Participants will be able to make additional voluntary deposits above the minimum amount. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test."
11232785|NCT02421224|OG002|Outcome|Small Individual Bonus|"Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test."
11232786|NCT02421224|OG003|Outcome|Large Individual Bonus|"Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group."
11232787|NCT02421224|OG004|Outcome|Team Bonus|"Same as Usual Care, plus each participant will be randomly assigned one teammate to provide social support during the quit attempt. If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.~Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group."
11232788|NCT02421224|OG005|Outcome|Deposits Plus Small Individual Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Small Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test."
11232789|NCT02421224|OG006|Outcome|Deposits Plus Large Individual Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Large Individual Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group."
11232790|NCT02421224|OG007|Outcome|Deposits Plus Teammate|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will be randomly assigned one other participant to serve as a teammate who provides social support during the quit attempt.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant."
11232791|NCT02421224|OG008|Outcome|Deposits Plus Team Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group, will be randomly assigned a teammate, and will follow the protocol for the monetary bonus as described for the Team Bonus group.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine test.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.~Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group."
11232792|NCT02421224|EG000|Reported Event|Usual Care|"Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.~Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan."
11232793|NCT02421224|EG001|Reported Event|Deposits|"Same as Usual Care, plus participants will have to deposit a certain amount of their own money as an incentive to quit smoking. Participants will be able to make additional voluntary deposits above the minimum amount. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Usual Care: Same as Usual Care only group.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test."
11232794|NCT02421224|EG002|Reported Event|Small Individual Bonus|"Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.~Usual Care: Same as Usual Care only group.~Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test."
11355359|NCT03832322|OG000|Outcome|Water Exchange Colonoscopy|During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, CO2 was opened during the withdrawal phase of the first-pass colonoscopy. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11355360|NCT03832322|OG001|Outcome|CO2 Insufflation Colonoscopy|During the first-pass colonoscopy, the procedure was performed in the usual fashion, with minimal CO2 insufflation to aid insertion. Cleaning of colon was predominantly performed during withdrawal. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11355361|NCT03832322|EG000|Reported Event|Water Exchange Colonoscopy|During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, CO2 was opened during the withdrawal phase of the first-pass colonoscopy. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11169133|NCT01989689|BG000|Baseline|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169134|NCT01989689|BG001|Baseline|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169135|NCT01989689|BG002|Baseline|Total|Total of all reporting groups
11169136|NCT01989689|FG000|Participant Flow|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169137|NCT01989689|FG001|Participant Flow|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169138|NCT01989689|OG000|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169139|NCT01989689|OG001|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169140|NCT01989689|OG000|Outcome|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169141|NCT01989689|OG001|Outcome|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169142|NCT01989689|EG000|Reported Event|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169143|NCT01989689|EG001|Reported Event|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
11169144|NCT01989754|BG000|Baseline|Placebo (Placebo)|Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.
11169145|NCT01989754|BG001|Baseline|Canagliflozin (Experimental)|Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
11169146|NCT01989754|BG002|Baseline|Total|Total of all reporting groups
11169147|NCT01989754|FG000|Participant Flow|Placebo (Placebo)|Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.
11169148|NCT01989754|FG001|Participant Flow|Canagliflozin (Experimental)|Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
11169149|NCT01989754|OG000|Outcome|Placebo|Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.
11355362|NCT03832322|EG001|Reported Event|CO2 Insufflation Colonoscopy|During the first-pass colonoscopy, the procedure was performed in the usual fashion, with minimal CO2 insufflation to aid insertion. Cleaning of colon was predominantly performed during withdrawal. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.
11232795|NCT02421224|EG003|Reported Event|Large Individual Bonus|"Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group.~Usual Care: Same as Usual Care only group.~Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group."
11232796|NCT02421224|EG004|Reported Event|Team Bonus|"Same as Usual Care, plus each participant will be randomly assigned one teammate to provide social support during the quit attempt. If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group.~Usual Care: Same as Usual Care only group.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.~Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group."
11232797|NCT02421224|EG005|Reported Event|Deposits Plus Small Individual Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Small Individual Bonus group.~Usual Care: Same as Usual Care only group.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test."
11232798|NCT02421224|EG006|Reported Event|Deposits Plus Large Individual Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Large Individual Bonus group.~Usual Care: Same as Usual Care only group.~Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.~Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group."
11232799|NCT02421224|EG007|Reported Event|Deposits Plus Teammate|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will be randomly assigned one other participant to serve as a teammate who provides social support during the quit attempt.~Usual Care: Same as Usual Care only group.~Deposits: Same as Deposits only group.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant."
11232800|NCT02421224|EG008|Reported Event|Deposits Plus Team Bonus|"Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group, will be randomly assigned a teammate, and will follow the protocol for the monetary bonus as described for the Team Bonus group.~Usual Care: Same as Usual Care only group.~Deposits: Same as Deposits only group.~Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.~Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group."
11232801|NCT02421354|BG000|Baseline|Treatment (Nivolumab)|"Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies"
11232802|NCT02421354|FG000|Participant Flow|Treatment (Nivolumab)|"Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies"
11232803|NCT02421354|OG000|Outcome|Treatment (Nivolumab)|"Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies"
11232804|NCT02421354|EG000|Reported Event|Treatment (Nivolumab)|"Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies"
11232805|NCT02421419|BG000|Baseline|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
11232806|NCT02421419|BG001|Baseline|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
11169150|NCT01989754|OG001|Outcome|Canagliflozin (Experimental)|Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
11169151|NCT01989754|EG000|Reported Event|Placebo (Placebo)|Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.
11169152|NCT01989754|EG001|Reported Event|Canagliflozin (Experimental)|Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
11169153|NCT01989793|BG000|Baseline|Losartan|"For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks.~Losartan: Losartan will be given in increasing doses to those in the losartan arm."
11169154|NCT01989793|BG001|Baseline|Placebo|"For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total.~Placebo: Placebo will be given to those in placebo arm"
11169155|NCT01989793|BG002|Baseline|Total|Total of all reporting groups
11169156|NCT01989793|FG000|Participant Flow|Losartan|"For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks.~Losartan: Losartan will be given in increasing doses to those in the losartan arm."
11169157|NCT01989793|FG001|Participant Flow|Placebo|"For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total.~Placebo: Placebo will be given to those in placebo arm"
11169158|NCT01989793|OG000|Outcome|Losartan|"For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks.~Losartan: Losartan will be given in increasing doses to those in the losartan arm."
11169159|NCT01989793|OG001|Outcome|Placebo|"For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total.~Placebo: Placebo will be given to those in placebo arm"
11169160|NCT01989793|EG000|Reported Event|Losartan|"For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks.~Losartan: Losartan will be given in increasing doses to those in the losartan arm."
11169161|NCT01989793|EG001|Reported Event|Placebo|"For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total.~Placebo: Placebo will be given to those in placebo arm"
11169162|NCT01989910|BG000|Baseline|Raltegravir|"Raltegravir 400mg oral twice daily~Efavirenz: Efavirenz 600mg oral at bedtime"
11169163|NCT01989910|BG001|Baseline|Efavirenz|"Efavirenz 600mg oral at bedtime~Raltegravir: Raltegravir 400mg oral twice daily"
11169164|NCT01989910|BG002|Baseline|Total|Total of all reporting groups
11169165|NCT01989910|FG000|Participant Flow|Raltegravir|"Raltegravir 400mg oral twice daily~Efavirenz: Efavirenz 600mg oral at bedtime"
11169166|NCT01989910|FG001|Participant Flow|Efavirenz|"Efavirenz 600mg oral at bedtime~Raltegravir: Raltegravir 400mg oral twice daily"
11169167|NCT01989910|OG000|Outcome|Raltegravir|"Raltegravir 400mg oral twice daily~Efavirenz: Efavirenz 600mg oral at bedtime"
11169168|NCT01989910|OG001|Outcome|Efavirenz|"Efavirenz 600mg oral at bedtime~Raltegravir: Raltegravir 400mg oral twice daily"
11169169|NCT01989910|EG000|Reported Event|Raltegravir|"Raltegravir 400mg oral twice daily~Efavirenz: Efavirenz 600mg oral at bedtime"
11169170|NCT01989910|EG001|Reported Event|Efavirenz|"Efavirenz 600mg oral at bedtime~Raltegravir: Raltegravir 400mg oral twice daily"
11169171|NCT01989975|BG000|Baseline|Diabetes Subjects With Sensor-Augmented Pump Therapy|Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
11169172|NCT01989975|FG000|Participant Flow|Diabetes Subjects With Sensor-Augmented Pump Therapy|Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
11169173|NCT01989975|OG000|Outcome|Diabetes Subjects With Sensor-Augmented Pump Therapy|Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
11169174|NCT01989975|EG000|Reported Event|Diabetes Subjects With Sensor-Augmented Pump Therapy|Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
11169175|NCT01990261|BG000|Baseline|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
11169176|NCT01990261|FG000|Participant Flow|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
11169177|NCT01990261|OG000|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
11169178|NCT01990261|EG000|Reported Event|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
11169179|NCT01990300|BG000|Baseline|Alogliptin/Pioglitazone|Alogliptin/Pioglitazone 25 mg/ 15 mg or 25 mg/ 30 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11169180|NCT01990300|FG000|Participant Flow|Alogliptin/Pioglitazone|Alogliptin/Pioglitazone 25 mg/ 15 mg or 25 mg/ 30 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11169181|NCT01990300|OG000|Outcome|Alogliptin/Pioglitazone|Alogliptin/Pioglitazone 25 mg/ 15 mg or 25 mg/ 30 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11169182|NCT01990300|EG000|Reported Event|Alogliptin/Pioglitazone|Alogliptin/Pioglitazone 25 mg/ 15 mg or 25 mg/ 30 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11169183|NCT01990313|BG000|Baseline|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
11169184|NCT01990313|FG000|Participant Flow|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
11169185|NCT01990313|OG000|Outcome|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
11169186|NCT01990313|EG000|Reported Event|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
11169187|NCT01990339|BG000|Baseline|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
11169188|NCT01990339|FG000|Participant Flow|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
11169189|NCT01990339|OG000|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
11169190|NCT01990339|EG000|Reported Event|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
11169191|NCT01990495|BG000|Baseline|Exercise|Subjects will participate in a center-based and home exercise training program for 3 months.
11169192|NCT01990495|BG001|Baseline|Usual Care|This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.
11169193|NCT01990495|BG002|Baseline|Total|Total of all reporting groups
11169194|NCT01990495|FG000|Participant Flow|Exercise|"The study involves two arms randomized to exercise and usual care groups~Exercise training: Subjects will participate in a center-based and home exercise training program for 3 months.~Usual Care: This group will serve as control subjects. They will receive only usual clinical care."
11169195|NCT01990495|FG001|Participant Flow|Usual Care|"This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.~Usual Care: This group will serve as control subjects. They will receive only usual clinical care."
11169196|NCT01990495|OG000|Outcome|Exercise|Subjects will participate in a center-based and home exercise training program for 3 months.
11169197|NCT01990495|OG001|Outcome|Usual Care|This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.
11169198|NCT01990495|OG000|Outcome|Exercise|Subjects will participate in a hybrid, center-based and home exercise training program for 3 months.
11169199|NCT01990495|OG001|Outcome|Usual Care|This group will serve as control subjects. They will receive only usual clinical care.
11169200|NCT01990495|EG000|Reported Event|Exercise|Subjects will participate in a center-based and home exercise training program for 3 months.
11169201|NCT01990495|EG001|Reported Event|Usual Care|This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.
11169202|NCT01990534|BG000|Baseline|Brentuximab Vedotin 1.8 mg/kg|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
11169203|NCT01990534|FG000|Participant Flow|Brentuximab Vedotin 1.8 mg/kg|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
11169204|NCT01990534|OG000|Outcome|Brentuximab Vedotin 1.8 mg/kg|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
11357381|NCT03760796|FG000|Participant Flow|Corrie Digital Health Platform Group|"Receives the Corrie Digital Health intervention plus the standard of care~Corrie Digital Health platform: The Corrie Digital Health platform consists of the Corrie smartphone app for heart attack recovery which is paired with an Apple Watch and Bluetooth-enabled, iHealth blood pressure cuff."
11169205|NCT01990534|EG000|Reported Event|Brentuximab Vedotin 1.8 mg/kg|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
11169206|NCT01990560|BG000|Baseline|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
11169207|NCT01990560|FG000|Participant Flow|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
11169208|NCT01990560|OG000|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
11169209|NCT01990560|EG000|Reported Event|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
11169210|NCT01990573|BG000|Baseline|Methadone 0.3 mg/kg|"0.3mg/kg IV methadone~0.3mg/kg IV methadone : Group I will receive 0.3mg/kg IV methadone"
11169211|NCT01990573|BG001|Baseline|Methadone 0.4 mg/kg|"0.4mg/kg IV methadone~0.4mg/kg IV methadone: Group II will receive 0.4mg/kg IV methadone ."
11169212|NCT01990573|BG002|Baseline|Control Group|"control no methadone, standard of care opioids.~control no methadone: The control group will not receive methadone."
11169213|NCT01990573|BG003|Baseline|Total|Total of all reporting groups
11169214|NCT01990573|FG000|Participant Flow|Methadone HCl 0.3 mg/kg|"0.3mg/kg IV methadone HCl~0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl"
11169215|NCT01990573|FG001|Participant Flow|Methadone HCl 0.4 mg/kg|"0.4mg/kg IV methadon HCl~0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl."
11169216|NCT01990573|FG002|Participant Flow|Control Group|"control no methadone, standard of care opioids.~control no methadone: The control group will not receive methadone."
11169217|NCT01990573|OG000|Outcome|Methadone HCl 0.3 mg/kg|"0.3mg/kg IV methadone HCl~0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl"
11169218|NCT01990573|OG001|Outcome|Methadone HCl 0.4 mg/kg|"0.4mg/kg IV methadon HCl~0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl."
11169219|NCT01990573|OG002|Outcome|Control Group|"control no methadone, standard of care opioids.~control no methadone: The control group will not receive methadone."
11169220|NCT01990573|EG000|Reported Event|Methadone HCl 0.3 mg/kg|"0.3mg/kg IV methadone HCl~0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl"
11169221|NCT01990573|EG001|Reported Event|Methadone HCl 0.4 mg/kg|"0.4mg/kg IV methadon HCl~0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl."
11169222|NCT01990573|EG002|Reported Event|Control Group|"control no methadone, standard of care opioids.~control no methadone: The control group will not receive methadone."
11169223|NCT01990612|BG000|Baseline|Expectant Management|Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
11169224|NCT01990612|BG001|Baseline|Elective Induction of Labor|"Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days~Elective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."
11169225|NCT01990612|BG002|Baseline|Total|Total of all reporting groups
11169226|NCT01990612|FG000|Participant Flow|Expectant Management|Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
11169227|NCT01990612|FG001|Participant Flow|Elective Induction of Labor|"Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days~Elective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."
11169228|NCT01990612|OG000|Outcome|Expectant Management|Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
11169229|NCT01990612|OG001|Outcome|Elective Induction of Labor|"Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days~Elective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."
11169230|NCT01990612|EG000|Reported Event|Expectant Management|Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
11169231|NCT01990612|EG001|Reported Event|Elective Induction of Labor|"Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days~Elective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."
11169232|NCT01990664|BG000|Baseline|Control (Senfilcon A)|Consists of subjects that were dispensed at least one Control lens.
11169233|NCT01990664|BG001|Baseline|Test (Senofilcon A)|Consists of subjects that were dispensed at least one Test lens.
11169234|NCT01990664|BG002|Baseline|Total|Total of all reporting groups
11357382|NCT03760796|FG001|Participant Flow|Historical Comparison Group|Receives the standard of care
11355363|NCT03832387|BG000|Baseline|Non-invasive Mechanical Ventilation|"Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.~The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.~Non-invasive mechanical ventilation~Continuous positive airway pressure"
11355364|NCT03832387|BG001|Baseline|Venturi Mask|"For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.~The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.~Venturi mask~Reservoir mask"
11355365|NCT03832387|BG002|Baseline|Total|Total of all reporting groups
11355366|NCT03832387|FG000|Participant Flow|Non-invasive Mechanical Ventilation|"Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.~The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.~Non-invasive mechanical ventilation~Continuous positive airway pressure"
11355367|NCT03832387|FG001|Participant Flow|Venturi Mask|"For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.~The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.~Venturi mask~Reservoir mask"
11355368|NCT03832387|OG000|Outcome|Non-invasive Mechanical Ventilation|"Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.~The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.~Non-invasive mechanical ventilation~Continuous positive airway pressure"
11355369|NCT03832387|OG001|Outcome|Venturi Mask|"For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.~The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.~Venturi mask~Reservoir mask"
11355370|NCT03832387|EG000|Reported Event|Non-invasive Mechanical Ventilation|"Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.~The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.~Non-invasive mechanical ventilation~Continuous positive airway pressure"
11355371|NCT03832387|EG001|Reported Event|Venturi Mask|"For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.~The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.~Venturi mask~Reservoir mask"
11355372|NCT03831971|BG000|Baseline|ANS-6637 & Midazolam|Subjects will receive (1) midazolam 5 mg po single dose on Day 1 followed by (2) Drug free period on Day 2 followed by (3) ANS-6637 600 mg po daily (Days 3-7) to reach steady state followed by (4) ANS-6637 600 mg po single dose + midazolam 5mg po single dose on Day 8
11355373|NCT03831971|FG000|Participant Flow|ANS-6637 & Midazolam|Subjects will receive (1) midazolam 5 mg po single dose on Day 1 followed by (2) Drug free period on Day 2 followed by (3) ANS-6637 600 mg po daily (Days 3-7) to reach steady state followed by (4) ANS-6637 600 mg po single dose + midazolam 5mg po single dose on Day 8
11355374|NCT03831971|OG000|Outcome|ANS-6637 & Midazolam|Subjects will receive (1) midazolam 5 mg po single dose on Day 1 followed by (2) Drug free period on Day 2 followed by (3) ANS-6637 600 mg po daily (Days 3-7) to reach steady state followed by (4) ANS-6637 600 mg po single dose + midazolam 5mg po single dose on Day 8
11355375|NCT03831971|EG000|Reported Event|ANS-6637 & Midazolam|Subjects will receive (1) midazolam 5 mg po single dose on Day 1 followed by (2) Drug free period on Day 2 followed by (3) ANS-6637 600 mg po daily (Days 3-7) to reach steady state followed by (4) ANS-6637 600 mg po single dose + midazolam 5mg po single dose on Day 8
11355376|NCT03831854|BG000|Baseline|Lamotrigine|Preoperatively, the patient will receive 300 mg of oral lamotrigine pill with small sips of water once.
11355377|NCT03831854|BG001|Baseline|Placebo|Preoperatively, the patient will receive a 300 mg oral placebo pill with small sips of water once.
11355378|NCT03831854|BG002|Baseline|Total|Total of all reporting groups
11355379|NCT03831854|FG000|Participant Flow|Lamotrigine|Preoperatively, the patient will receive 300 mg of oral lamotrigine pill with small sips of water once.
11355380|NCT03831854|FG001|Participant Flow|Placebo|Preoperatively, the patient will receive a 300 mg oral placebo pill with small sips of water once.
11355381|NCT03831854|OG000|Outcome|Lamotrigine|Preoperatively, the patient will receive 300 mg of oral lamotrigine pill with small sips of water once.
11355382|NCT03831854|OG001|Outcome|Placebo|Preoperatively, the patient will receive a 300 mg oral placebo pill with small sips of water once.
11355383|NCT03831854|EG000|Reported Event|Lamotrigine|"Patient will receive 300 mg of oral lamotrigine with small sips of water to reduce the psychologic side effects (measured by four key items of Brief Psychiatric Rating Scale: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) of intraoperative ketamine use.~Lamotrigine 300 MG: 300 mg of oral Lamotrigine. One of the key studies in this area was reported at the Society of Neuroscience meeting in 1997 and later published in the Archives of General Psychiatry. This study reported that, in healthy subjects 300 mg oral lamotrigine significantly decreased ketamine-induced perceptual abnormalities as assessed by the Clinician-Administered Dissociative States Scale (P<.001).31 Furthermore lamotrigine increased the immediate mood-elevating effects of ketamine (P<.05).~Ketamine: 1mg/kg bolus at induction followed by 5 microgram/kg/min infusion till the end of the surgery"
11355384|NCT03831854|EG001|Reported Event|Placebo|"Patient will receive oral Placebo with small sips of water, to reduce the psychologic side effects (measured by four key items of Brief Psychiatric Rating Scale: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) of intraoperative ketamine use.~Placebo: 300 mg of oral Placebo~Ketamine: 1mg/kg bolus at induction followed by 5 microgram/kg/min infusion till the end of the surgery"
11355385|NCT03807739|BG000|Baseline|Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation|In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal.
11355386|NCT03807739|BG001|Baseline|Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation|In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal.
11355387|NCT03807739|BG002|Baseline|Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation|In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions.
11355388|NCT03807739|BG003|Baseline|Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation|In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions.
11169235|NCT01990664|FG000|Participant Flow|Control (Senfilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
11355389|NCT03807739|BG004|Baseline|Total|Total of all reporting groups
11355390|NCT03807739|FG000|Participant Flow|Part 1: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation|In Part 1 participants received single doses of either GDC-0134 F09 or GDC-0134 F16 capsules (prototype) after having consumed a standard meal.
11355391|NCT03807739|FG001|Participant Flow|Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation|In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal.
11355392|NCT03807739|FG002|Participant Flow|Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation|In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions.
11355393|NCT03807739|FG003|Participant Flow|Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation|In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions.
11355394|NCT03807739|OG000|Outcome|Part 1 GDC-0134 F16 Capsule Fed|In Part 1 participants received single doses of GDC-0134 F16 after having consumed a standard meal.
11355395|NCT03807739|OG001|Outcome|Part 1 GDC-0134 F09 Capsule Fed|In Part I participants received single doses of GDC-0134 F09 capsules after having consumed a standard meal.
11355396|NCT03807739|OG002|Outcome|Part 2 GDC-0134 F15 Fasted|In Part 2, participants received a single dose of GDC-0134 F15 capsules after an overnight fast.
11355397|NCT03807739|OG003|Outcome|Part 2 GDC-0134 F09 Capsule Fasted|In Part 2, participants received a single dose of GDC-0134 F09 capsules after an overnight fast.
11355398|NCT03807739|OG000|Outcome|Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation|In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal.
11355399|NCT03807739|OG001|Outcome|Part II: GDC-0134 F15 vs F09 Capsule Formulation|In Part 2, participants received a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.
11355400|NCT03807739|EG000|Reported Event|Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation|In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal.
11355401|NCT03807739|EG001|Reported Event|Part II: GDC-0134 F15 vs F09 Capsule Formulation|In Part 2, participants received a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.
11355402|NCT03831282|BG000|Baseline|RD SET Neo SpO2|"All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.~RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor."
11355403|NCT03831282|FG000|Participant Flow|RD SET Neo SpO2|"All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.~RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor."
11355404|NCT03831282|OG000|Outcome|RD SET Neo SpO2|"All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.~RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor."
11232807|NCT02421419|BG002|Baseline|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
11232808|NCT02421419|BG003|Baseline|Total|Total of all reporting groups
11232809|NCT02421419|FG000|Participant Flow|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
11232810|NCT02421419|FG001|Participant Flow|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
11232811|NCT02421419|FG002|Participant Flow|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
11232812|NCT02421419|OG000|Outcome|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
11232813|NCT02421419|OG001|Outcome|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
11232814|NCT02421419|OG002|Outcome|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
11232815|NCT02421419|EG000|Reported Event|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
11232816|NCT02421419|EG001|Reported Event|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
11232817|NCT02421419|EG002|Reported Event|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
11232818|NCT02421510|BG000|Baseline|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232819|NCT02421510|BG001|Baseline|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232820|NCT02421510|BG002|Baseline|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232821|NCT02421510|BG003|Baseline|Total|Total of all reporting groups
11232822|NCT02421510|FG000|Participant Flow|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232823|NCT02421510|FG001|Participant Flow|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232824|NCT02421510|FG002|Participant Flow|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232825|NCT02421510|OG000|Outcome|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232826|NCT02421510|OG001|Outcome|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232827|NCT02421510|OG002|Outcome|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232828|NCT02421510|EG000|Reported Event|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232829|NCT02421510|EG001|Reported Event|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232830|NCT02421510|EG002|Reported Event|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
11232831|NCT02421588|BG000|Baseline|Lurbinectedin|3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
11232832|NCT02421588|BG001|Baseline|Control (PLD or Topotecan)|Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
11232833|NCT02421588|BG002|Baseline|Total|Total of all reporting groups
11169236|NCT01990664|FG001|Participant Flow|Test (Senofilcon A)|Subjects that were randomized to receive theTest lens for the duration of the study.
11169237|NCT01990664|OG000|Outcome|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
11169238|NCT01990664|OG001|Outcome|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
11169239|NCT01990664|EG000|Reported Event|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
11169240|NCT01990664|EG001|Reported Event|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
11169241|NCT01990677|BG000|Baseline|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
11169242|NCT01990677|BG001|Baseline|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
11169243|NCT01990677|BG002|Baseline|Total|Total of all reporting groups
11169244|NCT01990677|FG000|Participant Flow|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
11169245|NCT01990677|FG001|Participant Flow|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
11169246|NCT01990677|OG000|Outcome|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
11169247|NCT01990677|OG001|Outcome|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
11169248|NCT01990677|EG000|Reported Event|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
11169249|NCT01990677|EG001|Reported Event|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
11169250|NCT01990703|BG000|Baseline|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
11232834|NCT02421588|FG000|Participant Flow|Lurbinectedin|3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
11232835|NCT02421588|FG001|Participant Flow|Control (PLD or Topotecan)|Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
11232836|NCT02421588|OG000|Outcome|Lurbinectedin|3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
11232837|NCT02421588|OG001|Outcome|Control (PLD or Topotecan)|Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
11232838|NCT02421588|EG000|Reported Event|Lurbinectedin|3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
11232839|NCT02421588|EG001|Reported Event|Control (PLD or Topotecan)|Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
11232840|NCT02421601|BG000|Baseline|SI-6603|Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
11232841|NCT02421601|FG000|Participant Flow|SI-6603|Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
11232842|NCT02421601|OG000|Outcome|SI-6603|Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
11232843|NCT02421601|EG000|Reported Event|SI-6603|Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
11232844|NCT02421666|BG000|Baseline|Behavioral PNMI|Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
11232845|NCT02421666|BG001|Baseline|Usual Care|eligible chronic HBV patients received usual care
11232846|NCT02421666|BG002|Baseline|Total|Total of all reporting groups
11232847|NCT02421666|FG000|Participant Flow|Behavioral PNMI|Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
11232848|NCT02421666|FG001|Participant Flow|Usual Care|eligible chronic HBV patients received usual care
11232849|NCT02421666|OG000|Outcome|Behavioral PNMI|Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
11232850|NCT02421666|OG001|Outcome|Usual Care|eligible chronic HBV patients received usual care
11232851|NCT02421666|EG000|Reported Event|Behavioral PNMI|Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
11232852|NCT02421666|EG001|Reported Event|Usual Care|eligible chronic HBV patients received usual care
11232853|NCT02421757|BG000|Baseline|Transcutaneous Magnetic Stimulation|"Transcutaneous Magnetic Stimulation~Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation"
11355405|NCT03831282|EG000|Reported Event|RD SET Neo SpO2|"All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.~RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor."
11232854|NCT02421757|BG001|Baseline|Sham Device|"Sham Device~Placebo: The placebo Transcutaneous device"
11232855|NCT02421757|BG002|Baseline|Total|Total of all reporting groups
11232856|NCT02421757|FG000|Participant Flow|Transcutaneous Magnetic Stimulation|"Transcutaneous Magnetic Stimulation~Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation"
11232857|NCT02421757|FG001|Participant Flow|Sham Device|"Sham Device~Placebo: The placebo Transcutaneous device"
11169251|NCT01990703|BG001|Baseline|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
11169252|NCT01990703|BG002|Baseline|Total|Total of all reporting groups
11169253|NCT01990703|FG000|Participant Flow|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
11169254|NCT01990703|FG001|Participant Flow|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
11169255|NCT01990703|OG000|Outcome|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
11169256|NCT01990703|OG001|Outcome|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
11169257|NCT01990703|EG000|Reported Event|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
11169258|NCT01990703|EG001|Reported Event|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
11169259|NCT01990742|BG000|Baseline|Palliative Care Team (PCTeam)|Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
11169260|NCT01990742|BG001|Baseline|Standard Care|Usual care will be provided to residents in the control homes.
11169261|NCT01990742|BG002|Baseline|Total|Total of all reporting groups
11169262|NCT01990742|FG000|Participant Flow|Palliative Care Team (PCTeam)|Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
11169263|NCT01990742|FG001|Participant Flow|Standard Care|Usual care will be provided to residents in the control homes.
11169264|NCT01990742|OG000|Outcome|Palliative Care Team (PCTeam)|Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
11169265|NCT01990742|OG001|Outcome|Standard Care|Usual care will be provided to residents in the control homes.
11169266|NCT01990742|EG000|Reported Event|Palliative Care Team (PCTeam)|Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
11169267|NCT01990742|EG001|Reported Event|Standard Care|Usual care will be provided to residents in the control homes.
11169268|NCT01990768|BG000|Baseline|Placebo|Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169269|NCT01990768|BG001|Baseline|Bolus-Maintenance|1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169270|NCT01990768|BG002|Baseline|Bolus Only|2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169271|NCT01990768|BG003|Baseline|Total|Total of all reporting groups
11169272|NCT01990768|FG000|Participant Flow|Placebo|Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169273|NCT01990768|FG001|Participant Flow|Bolus-Maintenance|1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169274|NCT01990768|FG002|Participant Flow|Bolus Only|2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169275|NCT01990768|OG000|Outcome|Placebo|Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169276|NCT01990768|OG001|Outcome|Bolus-Maintenance|1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169277|NCT01990768|OG002|Outcome|Bolus Only|2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169278|NCT01990768|OG003|Outcome|Combined TXA Arms|Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
11169279|NCT01990768|EG000|Reported Event|Placebo|Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169280|NCT01990768|EG001|Reported Event|Bolus-Maintenance|1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169281|NCT01990768|EG002|Reported Event|Bolus Only|2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
11169282|NCT01990794|BG000|Baseline|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
11169283|NCT01990794|FG000|Participant Flow|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
11169284|NCT01990794|OG000|Outcome|Albumin-Co Fraction|Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
11169285|NCT01990794|OG000|Outcome|SI Before Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
11232858|NCT02421757|OG000|Outcome|Transcutaneous Magnetic Stimulation|"Transcutaneous Magnetic Stimulation~Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation"
11232859|NCT02421757|OG001|Outcome|Sham Device|"Sham Device~Placebo: The placebo Transcutaneous device"
11232860|NCT02421757|EG000|Reported Event|Transcutaneous Magnetic Stimulation|"Transcutaneous Magnetic Stimulation~Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation"
11232861|NCT02421757|EG001|Reported Event|Sham Device|"Sham Device~Placebo: The placebo Transcutaneous device"
11232862|NCT02421887|BG000|Baseline|Antioxidant Supplement|"Tablet: Vitamin C, 500 mg; Vitamin D3, 1000 IU; Vitamin E, 400 IU; Folic Acid 1000 mcg; Zinc, 20 mg; Selenium 200 mcg; Lycopene, 10 mg; Capsule: Vitamin D3, 1000 IU, L-Carnitine, 1000 mg~Antioxidant Supplement: An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine"
11232863|NCT02421887|BG001|Baseline|Placebo|Placebo: Placebo
11232864|NCT02421887|BG002|Baseline|Total|Total of all reporting groups
11232865|NCT02421887|FG000|Participant Flow|Antioxidant Supplement|"Tablet: Vitamin C, 500 mg; Vitamin D3, 1000 IU; Vitamin E, 400 IU; Folic Acid 1000 mcg; Zinc, 20 mg; Selenium 200 mcg; Lycopene, 10 mg; Capsule: Vitamin D3, 1000 IU, L-Carnitine, 1000 mg~Antioxidant Supplement: An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine"
11232866|NCT02421887|FG001|Participant Flow|Placebo|Placebo: Placebo
11232867|NCT02421887|OG000|Outcome|Antioxidant Supplement|"Tablet: Vitamin C, 500 mg; Vitamin D3, 1000 IU; Vitamin E, 400 IU; Folic Acid 1000 mcg; Zinc, 20 mg; Selenium 200 mcg; Lycopene, 10 mg; Capsule: Vitamin D3, 1000 IU, L-Carnitine, 1000 mg~Antioxidant Supplement: An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine"
11232868|NCT02421887|OG001|Outcome|Placebo|Placebo: Placebo
11232869|NCT02421887|EG000|Reported Event|Antioxidant Supplement|"Tablet: Vitamin C, 500 mg; Vitamin D3, 1000 IU; Vitamin E, 400 IU; Folic Acid 1000 mcg; Zinc, 20 mg; Selenium 200 mcg; Lycopene, 10 mg; Capsule: Vitamin D3, 1000 IU, L-Carnitine, 1000 mg~Antioxidant Supplement: An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine"
11232870|NCT02421887|EG001|Reported Event|Placebo|Placebo: Placebo
11232871|NCT02421952|BG000|Baseline|Single Cohort|All subjects will be asked to assess their pain and nausea using the visual analogue scales (VAS), the modified faces scale and the BARF scale as described below in the preoperative and postoperative areas.
11232872|NCT02421952|FG000|Participant Flow|Single Cohort|The study design is a cross sectional study of patients undergoing surgery. There was no group assignment, no placebo group and each subject was his or her own control. All patients were asked to assess their pain and nausea using the visual analogue scales (VAS), the modified faces scale, and the BARF scale in the preoperative and postoperative areas.
11232873|NCT02421952|OG000|Outcome|Single Cohort|Includes subjects who consented to participate, passed the seriation task, remained cooperative during the baseline assessment, and whose surgeries were not cancelled following informed consent.
11232874|NCT02421952|OG000|Outcome|Single Cohort|The study design is a cross sectional study of patients undergoing surgery. There was no group assignment, no placebo group and each subject was his or her own control. All patients were asked to assess their pain and nausea using the visual analogue scales (VAS), the modified faces scale, and the BARF scale in the preoperative and postoperative areas.
11232875|NCT02421952|OG000|Outcome|Sensitivity|ROC Curve Using Age as Cutoff Points
11232876|NCT02421952|OG001|Outcome|Specificity|ROC Curve Using Age as Cutoff Points
11232877|NCT02421952|EG000|Reported Event|Single Cohort|The study design is a cross sectional study of patients undergoing surgery. There was no group assignment, no placebo group and each subject was his or her own control. All patients were asked to assess their pain and nausea using the visual analogue scales (VAS), the modified faces scale, and the BARF scale in the preoperative and postoperative areas.
11232878|NCT02422186|BG000|Baseline|Intranasal Esketamine Plus Oral Antidepressant (AD)|Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
11232879|NCT02422186|BG001|Baseline|Oral AD Plus Intranasal Placebo|Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
11232880|NCT02422186|BG002|Baseline|Total|Total of all reporting groups
11233978|NCT02431650|FG001|Participant Flow|OZ439 500mg|"Administration of OZ439 500mg.~Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. When PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants will receive 500mg of OZ439."
11169286|NCT01990794|OG001|Outcome|SI After Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
11355406|NCT03824912|BG000|Baseline|Test: Ketoconazole Cream 2%|"Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)~Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355407|NCT03824912|BG001|Baseline|Reference: Ketoconazole Cream 2%|"Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)~Ketoconazole Cream 2% (G&W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355408|NCT03824912|BG002|Baseline|Placebo: Cream (Test Vehicle)|"Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)~Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355409|NCT03824912|BG003|Baseline|Total|Total of all reporting groups
11355410|NCT03824912|FG000|Participant Flow|Test: Ketoconazole Cream 2%|"Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)~Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355411|NCT03824912|FG001|Participant Flow|Reference: Ketoconazole Cream 2%|"Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)~Ketoconazole Cream 2% (G&W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355412|NCT03824912|FG002|Participant Flow|Placebo: Cream (Test Vehicle)|"Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)~Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355413|NCT03824912|OG000|Outcome|Test: Ketoconazole Cream 2%|"Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)~Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355414|NCT03824912|OG001|Outcome|Reference: Ketoconazole Cream 2%|"Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)~Ketoconazole Cream 2% (G&W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355415|NCT03824912|OG002|Outcome|Placebo: Cream (Test Vehicle)|"Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)~Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11169287|NCT01990794|OG000|Outcome|Female Hgb|Hgb levels before, during and after dosing
11169288|NCT01990794|OG001|Outcome|Male Hgb|Hgb levels before, during, and after dosing
11169289|NCT01990794|OG000|Outcome|Baseline - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
11169290|NCT01990794|OG001|Outcome|Baseline - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
11169291|NCT01990794|OG002|Outcome|Study Midpoint - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
11169292|NCT01990794|OG003|Outcome|Study Midpoint - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
11355416|NCT03824912|EG000|Reported Event|Test: Ketoconazole Cream 2%|"Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)~Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355417|NCT03824912|EG001|Reported Event|Reference: Ketoconazole Cream 2%|"Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)~Ketoconazole Cream 2% (G&W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355418|NCT03824912|EG002|Reported Event|Placebo: Cream (Test Vehicle)|"Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)~Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses."
11355419|NCT03822884|BG000|Baseline|Hemax PFS - Hemax - Eprex|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)~nd Period: 40,000 UI (SC) of Hemax (lyophilized)~rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)"
11355420|NCT03822884|BG001|Baseline|Hemax PFS - Eprex - Hemax|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)~nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)~rd Period: 40,000 UI (SC) of Hemax (lyophilized)"
11169293|NCT01990794|OG004|Outcome|Study Completion - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
11169294|NCT01990794|OG005|Outcome|Study Completion - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
11169295|NCT01990794|OG000|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
11169296|NCT01990794|OG001|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
11355421|NCT03822884|BG002|Baseline|Hemax - Hemax PFS - Eprex|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Hemax (lyophilized)~nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)~rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)"
11355422|NCT03822884|BG003|Baseline|Hemax - Eprex - Hemax PFS|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Hemax (lyophilized)~nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)~rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)"
11355423|NCT03822884|BG004|Baseline|Eprex - Hemax PFS - Hemax|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)~nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)~rd Period: 40,000 UI (SC) of Hemax (lyophilized)"
11355424|NCT03822884|BG005|Baseline|Eprex - Hemax - Hemax PFS|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)~nd Period: 40,000 UI (SC) of Hemax (lyophilized)~rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)"
11355425|NCT03822884|BG006|Baseline|Total|Total of all reporting groups
11355426|NCT03822884|FG000|Participant Flow|Hemax PFS - Hemax - Eprex|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)~nd Period: 40,000 UI (SC) of Hemax (lyophilized)~rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)"
11355427|NCT03822884|FG001|Participant Flow|Hemax PFS - Eprex - Hemax|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)~nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)~rd Period: 40,000 UI (SC) of Hemax (lyophilized)"
11355428|NCT03822884|FG002|Participant Flow|Hemax - Hemax PFS - Eprex|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Hemax (lyophilized)~nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)~rd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)"
11355429|NCT03822884|FG003|Participant Flow|Hemax - Eprex - Hemax PFS|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Hemax (lyophilized)~nd Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)~rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)"
11355430|NCT03822884|FG004|Participant Flow|Eprex - Hemax PFS - Hemax|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)~nd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)~rd Period: 40,000 UI (SC) of Hemax (lyophilized)"
11355431|NCT03822884|FG005|Participant Flow|Eprex - Hemax - Hemax PFS|"Volunteers in this groups received~st Period: 40,000 UI (SC) of Eprex/Erypo (reference rhEPO)~nd Period: 40,000 UI (SC) of Hemax (lyophilized)~rd Period: 40,000 UI (SC) of Hemax PFS (liquid formulation, without Albumin)"
11355432|NCT03822884|OG000|Outcome|Hemax® PFS 40,000 UI|"Epoetin Alfa 40000 UNT/ML subcutaneous single dose~Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose"
11355433|NCT03822884|OG001|Outcome|Hemax® 40,000 UI|"Epoetin Alfa 40000 UNT/ML subcutaneous single dose~Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose"
11355434|NCT03822884|OG002|Outcome|Erypo ® 40,000 UI|"Epoetin Alfa 40000 UNT/ML subcutaneous single dose~Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose"
11355435|NCT03822884|EG000|Reported Event|Hemax® PFS 40,000 UI|"Epoetin Alfa 40000 UNT/ML subcutaneous single dose~Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose"
11355436|NCT03822884|EG001|Reported Event|Hemax® 40,000 UI|"Epoetin Alfa 40000 UNT/ML subcutaneous single dose~Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose"
11355437|NCT03822884|EG002|Reported Event|Erypo ® 40,000 UI|"Epoetin Alfa 40000 UNT/ML subcutaneous single dose~Epoetin Alfa 40000 UNT/ML: 40.000 UI subcutaneous single dose"
11355438|NCT03816709|BG000|Baseline|Therapeutic Ultrasound Treatment|"All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.~Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes."
11355439|NCT03816709|FG000|Participant Flow|Therapeutic Ultrasound Treatment|"All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.~Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes."
11355440|NCT03816709|OG000|Outcome|Therapeutic Ultrasound Treatment|"All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.~Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes at the depths of 1.0, 1.75, and 2.5 cm."
11355441|NCT03816709|EG000|Reported Event|Therapeutic Ultrasound Treatment|"All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.~Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes at the depths of 1.0, 1.75, and 2.5 cm."
11355442|NCT03810014|BG000|Baseline|Arm 1|"The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).~Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0)."
11355443|NCT03810014|BG001|Baseline|Arm 2|"The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).~Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)."
11355444|NCT03810014|BG002|Baseline|Arm 3|"The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).~Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0)."
11355445|NCT03810014|BG003|Baseline|Arm 4|"The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)~Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)"
11355446|NCT03810014|BG004|Baseline|Total|Total of all reporting groups
11355447|NCT03810014|FG000|Participant Flow|Arm 1|"The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).~Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0)."
11355448|NCT03810014|FG001|Participant Flow|Arm 2|"The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).~Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)."
11355449|NCT03810014|FG002|Participant Flow|Arm 3|"The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).~Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0)."
11355450|NCT03810014|FG003|Participant Flow|Arm 4|"The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)~Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)"
11355451|NCT03810014|OG000|Outcome|Arm 1|"The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).~Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0)."
11355452|NCT03810014|OG001|Outcome|Arm 2|"The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).~Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)."
11355453|NCT03810014|OG002|Outcome|Arm 3|"The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).~Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0)."
11355454|NCT03810014|OG003|Outcome|Arm 4|"The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)~Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)"
11355455|NCT03810014|EG000|Reported Event|Arm 1|"The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).~Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0)."
11355456|NCT03810014|EG001|Reported Event|Arm 2|"The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).~Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)."
11355457|NCT03810014|EG002|Reported Event|Arm 3|"The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).~Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0)."
11355458|NCT03810014|EG003|Reported Event|Arm 4|"The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)~Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)"
11355459|NCT03806270|BG000|Baseline|Midazolam|"Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice"
11355460|NCT03806270|BG001|Baseline|Midazolam&Hydroxyzine dihydrochloride1/2|"Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice~Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally"
11355461|NCT03806270|BG002|Baseline|Midazolam&Hydroxyzine Dihydrochloride|"Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice~Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally"
11355462|NCT03806270|BG003|Baseline|Total|Total of all reporting groups
11355463|NCT03806270|FG000|Participant Flow|Midazolam|"Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice"
11355464|NCT03806270|FG001|Participant Flow|Midazolam&Hydroxyzine dihydrochloride1/2|"Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice~Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally"
11355465|NCT03806270|FG002|Participant Flow|Midazolam&Hydroxyzine Dihydrochloride|"Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice~Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally"
11355466|NCT03806270|OG000|Outcome|Midazolam|"Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice"
11355467|NCT03806270|OG001|Outcome|Midazolam&Hydroxyzine dihydrochloride1/2|"Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice~Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally"
11355468|NCT03806270|OG002|Outcome|Midazolam&Hydroxyzine Dihydrochloride|"Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice~Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally"
11355469|NCT03806270|EG000|Reported Event|Midazolam|"Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial. The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups, patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice"
11355470|NCT03806270|EG001|Reported Event|Midazolam&Hydroxyzine Dihydrochloride|"Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial. The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice~Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally"
11355471|NCT03806270|EG002|Reported Event|Midazolam&Hydroxyzine dihydrochloride1/2|"Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial. The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.~In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.~Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice~Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally"
11355472|NCT03830892|BG000|Baseline|E-cigarette User (Exclusive)|"Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette~E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power"
11355473|NCT03830892|BG001|Baseline|Dual User|"Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette~E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power~Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power"
11355474|NCT03830892|BG002|Baseline|Total|Total of all reporting groups
11355475|NCT03830892|FG000|Participant Flow|E-cigarette User (Exclusive)|"Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette~E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power"
11355476|NCT03830892|FG001|Participant Flow|Dual User|"Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette~E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power~Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power"
11355477|NCT03830892|OG000|Outcome|E-cigarette User (Exclusive)|"Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette~E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power"
11355478|NCT03830892|OG001|Outcome|Dual User|"Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette~E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power~Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power"
11355479|NCT03830892|EG000|Reported Event|E-cigarette User (Exclusive)|"Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette~E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power"
11355480|NCT03830892|EG001|Reported Event|Dual User|"Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette~E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power~E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power~Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power~Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power"
11355481|NCT03830307|BG000|Baseline|Intervention Group|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.~NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care"
11355482|NCT03830307|FG000|Participant Flow|Intervention Group|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.~NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care"
11355483|NCT03830307|OG000|Outcome|Intervention Group|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.~NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care"
11355484|NCT03830307|EG000|Reported Event|Intervention Group|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.~NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care"
11355485|NCT03825042|BG000|Baseline|Food Supplement|"A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks~A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets"
11355486|NCT03825042|BG001|Baseline|Placebo|"Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks~Placebo: Inactive compound in oral tablets"
11355487|NCT03825042|BG002|Baseline|Total|Total of all reporting groups
11355488|NCT03825042|FG000|Participant Flow|Food Supplement|"A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks~A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets"
11355489|NCT03825042|FG001|Participant Flow|Placebo|"Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks~Placebo: Inactive compound in oral tablets"
11355490|NCT03825042|OG000|Outcome|Food Supplement|"A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks~A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets"
11089790|NCT01525550|EG000|Reported Event|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
11355491|NCT03825042|OG001|Outcome|Placebo|"Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks~Placebo: Inactive compound in oral tablets"
11355492|NCT03825042|EG000|Reported Event|Food Supplement|"A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks~A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets"
11355493|NCT03825042|EG001|Reported Event|Placebo|"Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks~Placebo: Inactive compound in oral tablets"
11355494|NCT03823378|BG000|Baseline|ABBV-599 in M16-063/ABBV-599 in M16-763|60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
11355495|NCT03823378|BG001|Baseline|ABBV-105 60 mg/UPA Placebo|60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355496|NCT03823378|BG002|Baseline|ABBV-105 20 mg/UPA Placebo|20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355497|NCT03823378|BG003|Baseline|ABBV-105 5 mg/UPA Placebo|5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355498|NCT03823378|BG004|Baseline|UPA 15 mg/ABBV-105 Placebo|15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
11355499|NCT03823378|BG005|Baseline|Placebo in M16-063/ABBV-599 in M16-763|Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
11355500|NCT03823378|BG006|Baseline|Total|Total of all reporting groups
11089791|NCT01525550|EG001|Reported Event|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
11355501|NCT03823378|FG000|Participant Flow|ABBV-599 in M16-063/ABBV-599 in M16-763|60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
11355502|NCT03823378|FG001|Participant Flow|ABBV-105 60 mg/UPA Placebo|60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355503|NCT03823378|FG002|Participant Flow|ABBV-105 20 mg/UPA Placebo|20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355504|NCT03823378|FG003|Participant Flow|ABBV-105 5 mg/UPA Placebo|5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355505|NCT03823378|FG004|Participant Flow|UPA 15 mg/ABBV-105 Placebo|15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
11355506|NCT03823378|FG005|Participant Flow|Placebo in M16-063/ABBV-599 in M16-763|Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
11355507|NCT03823378|OG000|Outcome|ABBV-599 in M16-063/ABBV-599 in M16-763|60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
11355508|NCT03823378|OG001|Outcome|ABBV-105 60 mg/UPA Placebo|60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355509|NCT03823378|OG002|Outcome|ABBV-105 20 mg/UPA Placebo|20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355510|NCT03823378|OG003|Outcome|ABBV-105 5 mg/UPA Placebo|5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355511|NCT03823378|OG004|Outcome|UPA 15 mg/ABBV-105 Placebo|15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
11355512|NCT03823378|OG005|Outcome|Placebo in M16-063/ABBV-599 in M16-763|Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
11355513|NCT03823378|EG000|Reported Event|ABBV-599 in M16-063/ABBV-599 in M16-763|60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
11355514|NCT03823378|EG001|Reported Event|ABBV-105 60 mg/UPA Placebo|60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355515|NCT03823378|EG002|Reported Event|ABBV-105 20 mg/UPA Placebo|20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11355516|NCT03823378|EG003|Reported Event|ABBV-105 5 mg/UPA Placebo|5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
11169297|NCT01990794|OG002|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
11355517|NCT03823378|EG004|Reported Event|UPA 15 mg/ABBV-105 Placebo|15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
11355518|NCT03823378|EG005|Reported Event|Placebo in M16-063/ABBV-599 in M16-763|Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
11355519|NCT03831191|BG000|Baseline|Placebo|"Induction Period:~Participants received placebo administered SC Q4W."
11355520|NCT03831191|BG001|Baseline|50 mg LY3375880|"Induction Period:~Participants received 50 mg LY3375880 administered SC Q4W."
11355521|NCT03831191|BG002|Baseline|150 mg LY3375880|"Induction Period:~Participants received 150 mg LY3375880 administered SC Q4W."
11355522|NCT03831191|BG003|Baseline|600 mg LY3375880|"Induction Period:~Participants received 600 mg LY3375880 administered SC Q4W."
11355523|NCT03831191|BG004|Baseline|Total|Total of all reporting groups
11355524|NCT03831191|FG000|Participant Flow|Placebo|"Induction Period:~Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W)."
11089792|NCT01525563|BG000|Baseline|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
11089793|NCT01525563|FG000|Participant Flow|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
11355525|NCT03831191|FG001|Participant Flow|50 mg LY3375880|"Induction Period:~Participants received 50 milligrams (mg) LY3375880 administered SC Q4W."
11355526|NCT03831191|FG002|Participant Flow|150 mg LY3375880|"Induction Period:~Participants received 150 mg LY3375880 administered SC Q4W."
11355527|NCT03831191|FG003|Participant Flow|600 mg LY3375880|"Induction Period:~Participants received 600 mg LY3375880 administered SC Q4W."
11355528|NCT03831191|FG004|Participant Flow|Placebo Responder to Placebo/300 mg LY3375880|"Maintenance Period:~Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .~Participants had received placebo SC Q4W during the induction period."
11355529|NCT03831191|FG005|Participant Flow|Placebo Non-Responder to 300 mg LY3375880|"Maintenance Period:~Participants received 300 mg LY3375880 administered SC Q4W.~Participants had received placebo SC Q4W during the induction period."
11355530|NCT03831191|FG006|Participant Flow|50 mg Responder to Placebo/50 mg LY3375880|"Maintenance Period:~Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.~Participants had received 50 mg LY3375880 SC Q4W during the induction period."
11355531|NCT03831191|FG007|Participant Flow|50 mg LY3375880 Responder to 50 mg LY3375880|"Maintenance Period:~Participants received 50 mg LY3375880 administered SC Q4W.~Participants had received 50 mg LY3375880 SC Q4W during the induction period."
11355532|NCT03831191|FG008|Participant Flow|50 mg LY3375880 Non-Responder to 150 mg LY3375880|"Maintenance Period:~Participants received 150 mg LY3375880 administered SC Q4W.~Participants had received 50 mg LY3375880 SC Q4W during the induction period."
11355533|NCT03831191|FG009|Participant Flow|150 mg Responder to Placebo/150 mg LY3375880|"Maintenance Period:~Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.~Participants had received 150 mg LY3375880 SC Q4W during the induction period."
11355534|NCT03831191|FG010|Participant Flow|150 mg LY3375880 Responder to 150 mg LY3375880|"Maintenance Period:~Participants received 150 mg LY3375880 administered SC Q4W.~Participants had received 150 mg LY3375880 SC Q4W during the induction period."
11355535|NCT03831191|FG011|Participant Flow|150 mg LY3375880 Non-Responder to 300 mg LY3375880|"Maintenance Period:~Participants received 300 mg LY3375880 administered SC Q4W.~Participants had received 150 mg LY3375880 SC Q4W during the induction period."
11355536|NCT03831191|FG012|Participant Flow|600 mg Responder to Placebo/600 mg LY3375880|"Maintenance Period:~Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.~Participants had received 600 mg LY3375880 SC Q4W during the induction period."
11355537|NCT03831191|FG013|Participant Flow|600 mg LY3375880 Responder to 600 mg LY3375880|"Maintenance Period:~Participants received 600 mg LY3375880 administered SC Q4W.~Participants had received 600 mg LY3375880 SC Q4W during the induction period."
11355538|NCT03831191|FG014|Participant Flow|600 mg LY3375880 Non-Responder to 600 mg LY3375880|"Maintenance Period:~Participants received 600 mg LY3375880 administered SC Q4W.~Participants had received 600 mg LY3375880 SC Q4W during the induction period."
11355539|NCT03831191|OG000|Outcome|Placebo|"Induction Period:~Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W)."
11355540|NCT03831191|OG001|Outcome|50 mg LY3375880|"Induction Period:~Participants received 50 mg LY3375880 administered SC Q4W."
11089794|NCT01525563|OG000|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
11355541|NCT03831191|OG002|Outcome|150 mg LY3375880|"Induction Period:~Participants received 150 mg LY3375880 administered SC Q4W."
11355542|NCT03831191|OG003|Outcome|600 mg LY3375880|"Induction Period:~Participants received 600 mg LY3375880 administered SC Q4W."
11355543|NCT03831191|OG000|Outcome|Placebo|Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
11355544|NCT03831191|OG001|Outcome|50 mg LY3375880|Participants received 50 mg LY3375880 administered SC Q4W.
11355545|NCT03831191|OG002|Outcome|150 mg LY3375880|Participants received 150 mg LY3375880 administered SC Q4W.
11355546|NCT03831191|OG003|Outcome|300 mg LY3375880|Participants received 300 mg LY3375880 administered SC Q4W.
11355547|NCT03831191|OG004|Outcome|600 mg LY3375880|Participants received 600 mg LY3375880 administered SC Q4W.
11355548|NCT03831191|OG000|Outcome|50 mg LY3375880|Participants received 50 mg LY3375880 administered SC Q4W.
11355549|NCT03831191|OG001|Outcome|150 mg LY3375880|Participants received 150 mg LY3375880 administered SC Q4W.
11355550|NCT03831191|OG002|Outcome|600 mg LY3375880|Participants received 600 mg LY3375880 administered SC Q4W.
11355551|NCT03831191|EG000|Reported Event|Placebo|"Induction Period:~Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W)."
11355552|NCT03831191|EG001|Reported Event|50 mg LY3375880|"Induction Period:~Participants received 50 mg LY3375880 administered SC Q4W."
11355553|NCT03831191|EG002|Reported Event|150 mg LY3375880|"Induction Period:~Participants received 150 mg LY3375880 administered SC Q4W."
11355554|NCT03831191|EG003|Reported Event|600 mg LY3375880|"Induction Period:~Participants received 600 mg LY3375880 administered SC Q4W."
11355555|NCT03831191|EG004|Reported Event|Placebo Responder to Placebo/300 mg LY3375880|"Maintenance Period:~Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .~Participants had received placebo SC Q4W during the induction period."
11355556|NCT03831191|EG005|Reported Event|Placebo Non-Responder to 300 mg LY3375880|"Maintenance Period:~Participants received 300 mg LY3375880 administered SC Q4W.~Participants had received placebo SC Q4W during the induction period."
11355557|NCT03831191|EG006|Reported Event|50 mg Responder to Placebo/50 mg LY3375880|"Maintenance Period:~Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.~Participants had received 50 mg LY3375880 SC Q4W during the induction period."
11355558|NCT03831191|EG007|Reported Event|50 mg LY3375880 Responder to 50 mg LY3375880|"Maintenance Period:~Participants received 50 mg LY3375880 administered SC Q4W.~Participants had received 50 mg LY3375880 SC Q4W during the induction period."
11355559|NCT03831191|EG008|Reported Event|50 mg LY3375880 Non-Responder to 150 mg LY3375880|"Maintenance Period:~Participants received 150 mg LY3375880 administered SC Q4W.~Participants had received 50 mg LY3375880 SC Q4W during the induction period."
11355560|NCT03831191|EG009|Reported Event|150 mg Responder to Placebo/150 mg LY3375880|"Maintenance Period:~Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.~Participants had received 150 mg LY3375880 SC Q4W during the induction period."
11355561|NCT03831191|EG010|Reported Event|150 mg LY3375880 Responder to 150 mg LY3375880|"Maintenance Period:~Participants received 150 mg LY3375880 administered SC Q4W.~Participants had received 150 mg LY3375880 SC Q4W during the induction period."
11355562|NCT03831191|EG011|Reported Event|150 mg LY3375880 Non-Responder to 300 mg LY3375880|"Maintenance Period:~Participants received 300 mg LY3375880 administered SC Q4W.~Participants had received 150 mg LY3375880 SC Q4W during the induction period."
11355563|NCT03831191|EG012|Reported Event|600 mg Responder to Placebo/600 mg LY3375880|"Maintenance Period:~Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.~Participants had received 600 mg LY3375880 SC Q4W during the induction period."
11355564|NCT03831191|EG013|Reported Event|600 mg LY3375880 Responder to 600 mg LY3375880|"Maintenance Period:~Participants received 600 mg LY3375880 administered SC Q4W.~Participants had received 600 mg LY3375880 SC Q4W during the induction period."
11355565|NCT03831191|EG014|Reported Event|600 mg LY3375880 Non-Responder to 600 mg LY3375880|"Maintenance Period:~Participants received 600 mg LY3375880 administered SC Q4W.~Participants had received 600 mg LY3375880 SC Q4W during the induction period."
11355566|NCT03831191|EG015|Reported Event|LY3375880-50mg-Q4W-Post-Treatment Follow-Up Period|Follow-up: participants did not receive drug during the follow-up period.
11355567|NCT03831191|EG016|Reported Event|LY3375880-150mg-Q4W-Post-Treatment Follow-Up Period|Follow-up: participants did not receive drug during the follow-up period.
11355568|NCT03831191|EG017|Reported Event|LY3375880-600mg-Q4W-Post-Treatment Follow-Up Period|Follow-up: participants did not receive drug during the follow-up period.
11355569|NCT03831191|EG018|Reported Event|Placebo-Post-Treatment Follow-Up Period|Follow-up: participants did not receive drug during the follow-up period.
11355570|NCT03830281|BG000|Baseline|Insulin Lispro (Humalog)|Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11355571|NCT03830281|BG001|Baseline|Ultra-Rapid Lispro|Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11355572|NCT03830281|BG002|Baseline|Total|Total of all reporting groups
11355573|NCT03830281|FG000|Participant Flow|Insulin Lispro (Humalog)|Participants received individual dose of 100 units per milliliter (U/mL) insulin lispro (Humalog) by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11355574|NCT03830281|FG001|Participant Flow|Ultra-Rapid Lispro|Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11355575|NCT03830281|OG000|Outcome|Insulin Lispro (Humalog)|Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11355576|NCT03830281|OG001|Outcome|Ultra-Rapid Lispro|Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11355577|NCT03830281|EG000|Reported Event|Insulin Lispro (Humalog) Lead-in|Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11355578|NCT03830281|EG001|Reported Event|Insulin Lispro (Humalog)|Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11355579|NCT03830281|EG002|Reported Event|Ultra-Rapid Lispro|Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
11089795|NCT01525563|EG000|Reported Event|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
11169298|NCT01990794|OG000|Outcome|Prestudy - Right|Values of the right eye for select ONH variables
11355580|NCT03828734|BG000|Baseline|All Participants|Participants will receive TMS while performing a cognitive control task. In one stimulation session, the TMS coil will be placed over the frontal cortex on the scalp. In another session, the TMS coil will be placed over the parietal cortex on the scalp. During every session, participants receive Alpha TMS, Theta TMS, and Arrhythmic TMS.
11355581|NCT03828734|FG000|Participant Flow|TMS to Frontal Cortex Followed by TMS to Parietal Cortex|Participants will receive transcranial magnetic stimulation (TMS) while performing a cognitive control task. In the first stimulation session, the TMS coil will be placed over the frontal cortex on the scalp. In the second session, the TMS coil will be placed over the parietal cortex on the scalp. During every session, participants receive Alpha TMS, Theta TMS, and Arrhythmic TMS.
11355582|NCT03828734|FG001|Participant Flow|TMS to Parietal Cortex Followed by TMS to Frontal Cortex|Participants will receive TMS while performing a cognitive control task. In their first stimulation session, the TMS coil will be placed over the parietal cortex on the scalp. In their second session, the TMS coil will be placed over the frontal cortex on the scalp. During every session, participants receive Alpha TMS, Theta TMS, and Arrhythmic TMS.
11355583|NCT03828734|OG000|Outcome|TMS to Frontal Cortex|Participants receive TMS to frontal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.
11355584|NCT03828734|OG001|Outcome|TMS to Parietal Cortex|Participants receive TMS to parietal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.
11355585|NCT03828734|EG000|Reported Event|TMS to Frontal Cortex|Participants receive TMS to frontal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.
11355586|NCT03828734|EG001|Reported Event|TMS to Parietal Cortex|Participants receive TMS to parietal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.
11355587|NCT03827395|BG000|Baseline|HEV-239|0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
11355588|NCT03827395|BG001|Baseline|Placebo|0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
11355589|NCT03827395|BG002|Baseline|Total|Total of all reporting groups
11357383|NCT03760796|OG000|Outcome|Corrie Digital Health Platform Group|"Receives the Corrie Digital Health intervention plus the standard of care~Corrie Digital Health platform: The Corrie Digital Health platform consists of the Corrie smartphone app for heart attack recovery which is paired with an Apple Watch and Bluetooth-enabled, iHealth blood pressure cuff."
11357384|NCT03760796|OG001|Outcome|Historical Comparison Group|Receives the standard of care
11355590|NCT03827395|FG000|Participant Flow|HEV-239|"0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.~HEV 239: Hepatitis E vaccine against HEV genotypes 1 and 4. The HEV 239 vaccine is a 26 kDa recombinant polypeptide corresponding to amino acid residues 368-606 of the capsid protein of a genotype 1 HEV strain. The vaccine is expressed in Escherichia coli (E. coli) and vaccine doses contain 30 µg of the purified antigen in 0.5 mL buffered saline adsorbed to 0.8 mg aluminium hydroxide."
11355591|NCT03827395|FG001|Participant Flow|Placebo|"0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.~Placebo: 0.9% Sodium Chloride Injection, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection (WFI). Each mL contains sodium chloride 9 mg and may contain HCl or NaOH for pH adjustment (pH 5.3 [4.5 - 7.0])."
11355592|NCT03827395|OG000|Outcome|HEV-239|0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
11355593|NCT03827395|OG001|Outcome|Placebo|0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
11169299|NCT01990794|OG001|Outcome|Prestudy - Left|Values of the left eye for select ONH variables
11355594|NCT03827395|EG000|Reported Event|HEV-239|0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
11355595|NCT03827395|EG001|Reported Event|Placebo|0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
11355596|NCT03819218|BG000|Baseline|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)"
11089796|NCT01525589|BG000|Baseline|Cohort A (BRCA+)|Patients with known deleterious BRCA1/2 mutation status at study entry
11169300|NCT01990794|OG002|Outcome|Study Midpoint - Right|Values of the right eye for select ONH variables
11169301|NCT01990794|OG003|Outcome|Study Midpoint - Left|Values of the left eye for select ONH variables
11355597|NCT03819218|FG000|Participant Flow|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)"
11355598|NCT03819218|OG000|Outcome|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)"
11355599|NCT03819218|EG000|Reported Event|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)"
11355600|NCT03818815|BG000|Baseline|Drug: OP0201 + Antibiotics|OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
11355601|NCT03818815|BG001|Baseline|Placebo Comparator: Placebo + Antibiotics|Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
11355602|NCT03818815|BG002|Baseline|Total|Total of all reporting groups
11355603|NCT03818815|FG000|Participant Flow|Drug: OP0201 + Antibiotics|"OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days~OP0201 20mg per day+Amoxicillin-clavulanate: OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days"
11355604|NCT03818815|FG001|Participant Flow|Placebo Comparator: Placebo +Antibiotics|"Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days~Placebo 0mg per day+Amoxicillin-clavulanate: Placebo 0mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days"
11355605|NCT03818815|OG000|Outcome|Drug: OP0201 + Antibiotics|OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
11089797|NCT01525589|BG001|Baseline|Cohort A1 (BRCA+/PARPi)|Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
11089798|NCT01525589|BG002|Baseline|Cohort B (Unselected)|"Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:~Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or~Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment."
11089799|NCT01525589|BG003|Baseline|Total|Total of all reporting groups
11089800|NCT01525589|FG000|Participant Flow|Cohort A (BRCA+)|Patients with known deleterious BRCA1/2 mutation status at study entry
11089801|NCT01525589|FG001|Participant Flow|Cohort A1 (BRCA+/PARPi)|Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
11355606|NCT03818815|OG001|Outcome|Placebo Comparator: Placebo + Antibiotics|Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
11355607|NCT03818815|EG000|Reported Event|Drug: OP0201 + Antibiotics|OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
11355608|NCT03818815|EG001|Reported Event|Placebo Comparator: Placebo + Antibiotics|Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
11355609|NCT03828487|BG000|Baseline|Neonatal Test Group|"Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.~Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates~510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates"
11355610|NCT03828487|FG000|Participant Flow|Neonatal Test Group|"Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.~Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates~510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates"
11355611|NCT03828487|OG000|Outcome|Neonatal Test Group|"Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.~Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates~510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates"
11355612|NCT03828487|EG000|Reported Event|Neonatal Test Group|"Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.~Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates~510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates"
11355613|NCT03828617|BG000|Baseline|20vPnC Lot 1|Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
11355614|NCT03828617|BG001|Baseline|20vPnC Lot 2|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.
11355615|NCT03828617|BG002|Baseline|20vPnC Lot 3|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
11355616|NCT03828617|BG003|Baseline|13vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
11355617|NCT03828617|BG004|Baseline|Total|Total of all reporting groups
11355618|NCT03828617|FG000|Participant Flow|20vPnC Lot 1|Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
11355619|NCT03828617|FG001|Participant Flow|20vPnC Lot 2|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.
11355620|NCT03828617|FG002|Participant Flow|20vPnC Lot 3|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
11355621|NCT03828617|FG003|Participant Flow|13vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
11355622|NCT03828617|OG000|Outcome|Pooled 20vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
10888007|NCT00504257|FG000|Participant Flow|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
11355623|NCT03828617|OG001|Outcome|13vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
11355624|NCT03828617|OG000|Outcome|20vPnC Lot 1|Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
11355625|NCT03828617|OG001|Outcome|20vPnC Lot 2|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.
11355626|NCT03828617|OG002|Outcome|20vPnC Lot 3|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
11355627|NCT03828617|EG000|Reported Event|Pooled 20vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
11355628|NCT03828617|EG001|Reported Event|13vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
11169302|NCT01990794|OG004|Outcome|Study Completion - Right|Values of the right eye for select ONH variables
11355629|NCT03828539|BG000|Baseline|Erenumab|70 mg and 140 mg Erenumab
11355630|NCT03828539|BG001|Baseline|Topiramate|Topiramate in the highest tolerated dose (50 - 100 mg/day)
11355631|NCT03828539|BG002|Baseline|Total|Total of all reporting groups
11355632|NCT03828539|FG000|Participant Flow|Erenumab|70 mg and 140 mg Erenumab
11355633|NCT03828539|FG001|Participant Flow|Topiramate|Topiramate in the highest tolerated dose (50 - 100 mg/day)
11355634|NCT03828539|OG000|Outcome|Erenumab|70 mg and 140 mg Erenumab
11355635|NCT03828539|OG001|Outcome|Topiramate|Topiramate in the highest tolerated dose (50 - 100 mg/day)
11355636|NCT03828539|EG000|Reported Event|Erenumab|70 mg and 140 mg Erenumab
11355637|NCT03828539|EG001|Reported Event|Topiramate|Topiramate in the highest tolerated dose (50 - 100 mg/day)
11355638|NCT03824704|BG000|Baseline|Cohort A: Ovarian Cancer Cohort|Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
11355639|NCT03824704|FG000|Participant Flow|Cohort A: Ovarian Cancer Cohort|Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
11355640|NCT03824704|OG000|Outcome|Cohort A: Ovarian Cancer Cohort|Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
11355641|NCT03824704|EG000|Reported Event|Cohort A: Ovarian Cancer Cohort|Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
11355642|NCT03823937|BG000|Baseline|Fibromyalgia|"Diagnosed with ACR 2016 criteria~Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
11355643|NCT03823937|BG001|Baseline|Control|"18-70 years healthy subjects~Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
11355644|NCT03823937|BG002|Baseline|Total|Total of all reporting groups
11355645|NCT03823937|FG000|Participant Flow|Fibromyalgia|"Diagnosed with ACR 2016 criteria~Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
11355646|NCT03823937|FG001|Participant Flow|Control|"18-70 years healthy subjects~Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
11355647|NCT03823937|OG000|Outcome|Fibromyalgia|"Diagnosed with ACR 2016 criteria~Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
11355648|NCT03823937|OG001|Outcome|Control|"18-70 years healthy subjects~Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
11355649|NCT03823937|EG000|Reported Event|Fibromyalgia|"Diagnosed with ACR 2016 criteria~Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
11355650|NCT03823937|EG001|Reported Event|Control|"18-70 years healthy subjects~Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
11355651|NCT03817879|BG000|Baseline|VivaSight Double-lumen Tube|VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera
11355652|NCT03817879|BG001|Baseline|Conventional Double-lumen Tube|Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
11355653|NCT03817879|BG002|Baseline|Total|Total of all reporting groups
11355654|NCT03817879|FG000|Participant Flow|VivaSight Double-lumen Tube|VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera
11355655|NCT03817879|FG001|Participant Flow|Conventional Double-lumen Tube|Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
11355656|NCT03817879|OG000|Outcome|VivaSight Double-lumen Tube|VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera
11355657|NCT03817879|OG001|Outcome|Conventional Double-lumen Tube|Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
11169303|NCT01990794|OG005|Outcome|Study Completion - Left|Values of the left eye for select ONH variables
11355658|NCT03817879|EG000|Reported Event|VivaSight Double-lumen Tube|VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera
11355659|NCT03817879|EG001|Reported Event|Conventional Double-lumen Tube|Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera
11355660|NCT03811834|BG000|Baseline|Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg +[14C]-Mobocertinib 160 mg|Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355661|NCT03811834|FG000|Participant Flow|Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg|Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 microcurie [mcCi]), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355662|NCT03811834|OG000|Outcome|Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg|Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.
11355663|NCT03811834|OG000|Outcome|[14C]-Mobocertinib 160 mg|[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355664|NCT03811834|OG000|Outcome|[14C]-Mobocertinib 160 mg|[14C]-mobocertinib160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355665|NCT03811834|OG000|Outcome|[14C]-Mobocertinib 160 mg|14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355666|NCT03811834|OG000|Outcome|[14C]-Mobocertinib 160 mg|[14C]-Mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355667|NCT03811834|OG000|Outcome|[14C]-Mobocertinib160 mg|[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355668|NCT03811834|OG000|Outcome|Mobocertinib160 mg and [14C]-Mobocertinib 50 mcg|Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously over 15 minutes, once on Day 1 of Period 1.
11355669|NCT03811834|OG000|Outcome|Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg|Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.
11355670|NCT03811834|OG001|Outcome|[14C]-Mobocertinib 160 mg|[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355671|NCT03811834|EG000|Reported Event|Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg|Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.
11355672|NCT03811834|EG001|Reported Event|[14C]-Mobocertinib 160 mg|[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
11355673|NCT03806127|BG000|Baseline|Placebo|Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).
11355674|NCT03806127|BG001|Baseline|Vibegron 75 mg|Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
11355675|NCT03806127|BG002|Baseline|Total|Total of all reporting groups
11355676|NCT03806127|FG000|Participant Flow|Placebo|Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).
11355677|NCT03806127|FG001|Participant Flow|Vibegron 75 mg|Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
11355678|NCT03806127|OG000|Outcome|Placebo|Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).
11355679|NCT03806127|OG001|Outcome|Vibegron 75 mg|Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
11355680|NCT03806127|EG000|Reported Event|Placebo|Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).
11355681|NCT03806127|EG001|Reported Event|Vibegron 75 mg|Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
11355682|NCT03827473|BG000|Baseline|Arm A (ADT, Docetaxel)|Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
11355683|NCT03827473|BG001|Baseline|Arm B (ADT, Abiraterone)|Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
11355684|NCT03827473|BG002|Baseline|Total|Total of all reporting groups
11355685|NCT03827473|FG000|Participant Flow|Arm A (ADT, Docetaxel)|Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
11169304|NCT01990794|OG000|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
11355686|NCT03827473|FG001|Participant Flow|Arm B (ADT, Abiraterone)|Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
11355687|NCT03827473|OG000|Outcome|Arm A (ADT, Docetaxel)|Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
11355688|NCT03827473|OG001|Outcome|Arm B (ADT, Abiraterone)|Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
11355689|NCT03827473|EG000|Reported Event|Arm A (ADT, Docetaxel)|Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
11355690|NCT03827473|EG001|Reported Event|Arm B (ADT, Abiraterone)|Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
11355691|NCT03826914|BG000|Baseline|Experimental Group|"Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.~CardioFlex Q10: CardioFlex Q10 is a cardiovascular health supplement developed to increase collagen production, repair connective tissues, and help the body metabolize fats and protein. CardioFlex Q10 contains high amounts of lysine, proline and vitamin C, which the body requires to produce connective tissue (collagen). CardioFlex Q10 also includes additional supporting nutrients such as vitamin E, selenium, bio flavonoids, Coenzyme Q10 (Ubiqionol) and magnesium. The ingredients in CardioFlex Q10 help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation."
11355692|NCT03826914|BG001|Baseline|Control Group|"Participants in the control group will be given a flavoured 10g maltodextrin placebo that looks and tastes exactly like Cardioflex Q10.~Placebo: Maltodextrin placebo that looks and tastes identical to CardioFLex Q10"
11355693|NCT03826914|BG002|Baseline|Total|Total of all reporting groups
11355694|NCT03826914|FG000|Participant Flow|Experimental Group|"Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.~CardioFlex Q10: CardioFlex Q10 is a cardiovascular health supplement developed to increase collagen production, repair connective tissues, and help the body metabolize fats and protein. CardioFlex Q10 contains high amounts of lysine, proline and vitamin C, which the body requires to produce connective tissue (collagen). CardioFlex Q10 also includes additional supporting nutrients such as vitamin E, selenium, bio flavonoids, Coenzyme Q10 (Ubiqionol) and magnesium. The ingredients in CardioFlex Q10 help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation."
11355695|NCT03826914|FG001|Participant Flow|Control Group|"Participants in the control group will be given a flavoured 10g maltodextrin placebo that looks and tastes exactly like Cardioflex Q10.~Placebo: Maltodextrin placebo that looks and tastes identical to CardioFLex Q10"
11355696|NCT03826914|OG000|Outcome|Cardioflex Group|Participants were given 1 serving (10g) of Cardioflex each day.
11355697|NCT03826914|OG001|Outcome|Placebo Group|Participants in the placebo group were given 10g of a maltodextrin placebo per day
11355698|NCT03826914|OG000|Outcome|Cardioflex|Participants in the Cardioflex group were given 1 serving (10g) of Cardioflex each day.
11355699|NCT03826914|OG001|Outcome|Placebo|Participants in the placebo group were given 10g of a maltodextrin placebo each day.
11355700|NCT03826914|EG000|Reported Event|Experimental Group|Participants were given one serving (10g) of cardioflex daily for 90 consecutive days.
11355701|NCT03826914|EG001|Reported Event|Control Group|Participants were given one serving of an isocaloric maltodextrin placebo daily for 90 consecutive days.
11355702|NCT03812328|BG000|Baseline|SelK2|I.V., single-dose
11355703|NCT03812328|BG001|Baseline|SelK2 and Enoxaparin|"I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)~SelK2: I.V., single-dose~Enoxaparin: SC, QD for up to 10 ± 2 days"
11355704|NCT03812328|BG002|Baseline|Enoxaparin|"SC, QD for up to 10 ± 2 days~Enoxaparin: SC, QD for up to 10 ± 2 days"
11355705|NCT03812328|BG003|Baseline|Total|Total of all reporting groups
11355706|NCT03812328|FG000|Participant Flow|SelK2|I.V., single-dose
11355707|NCT03812328|FG001|Participant Flow|SelK2 and Enoxaparin|I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
11169305|NCT01990794|OG001|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
11169306|NCT01990794|OG002|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
11355708|NCT03812328|FG002|Participant Flow|Enoxaparin|QD for up to 10 ± 2 days
11355709|NCT03812328|OG000|Outcome|SelK2|I.V., single-dose
11355710|NCT03812328|OG001|Outcome|SelK2 and Enoxaparin|"I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)~SelK2: I.V., single-dose~Enoxaparin: SC, QD for up to 10 ± 2 days"
11355711|NCT03812328|OG002|Outcome|Enoxaparin|"SC, QD for up to 10 ± 2 days~Enoxaparin: SC, QD for up to 10 ± 2 days"
11355712|NCT03812328|EG000|Reported Event|SelK2|I.V., single-dose
11355713|NCT03812328|EG001|Reported Event|SelK2 and Enoxaparin|"I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)~SelK2: I.V., single-dose~Enoxaparin: SC, QD for up to 10 ± 2 days"
11355714|NCT03812328|EG002|Reported Event|Enoxaparin|"SC, QD for up to 10 ± 2 days~Enoxaparin: SC, QD for up to 10 ± 2 days"
11355715|NCT03808688|BG000|Baseline|Netarsudil Ophthalmic Solution 0.02% Monotherapy|Netarsudil Ophthalmic Solution 0.02% Monotherapy - 1 drop in each eye once daily in the evening.
11355716|NCT03808688|BG001|Baseline|Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy|Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
11355717|NCT03808688|BG002|Baseline|Total|Total of all reporting groups
11355718|NCT03808688|FG000|Participant Flow|Netarsudil Ophthalmic Solution 0.02% Monotherapy|Netarsudil Ophthalmic Solution 0.02% Monotherapy: 1 drop in each eye once daily in the evening.
11355719|NCT03808688|FG001|Participant Flow|Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy|Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
11355720|NCT03808688|OG000|Outcome|Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline|During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Treatment naïve at baseline visit. 1 drop in each eye once daily in the evening.
11355721|NCT03808688|OG001|Outcome|Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent|During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Replaced 1 agent at baseline visit (majority were PGA replacements). 1 drop in each eye once daily in the evening.
11355722|NCT03808688|OG002|Outcome|Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents|During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Replaced 2 agents at baseline visit (including PGA and FDC replacements). 1 drop in each eye once daily in the evening.
11355723|NCT03808688|OG003|Outcome|Netarsudil Ophth Sol 0.02% Concomitant Therapy|During study Netarsudil Ophthalmic Solution 0.02% - Used concomitantly with other IOP lowering agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
11355724|NCT03808688|EG000|Reported Event|Netarsudil Ophthalmic Solution 0.02% Monotherapy|Netarsudil Ophthalmic Solution 0.02% Monotherapy. 1 drop in each eye once daily in the evening.
11355725|NCT03808688|EG001|Reported Event|Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy|Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
11355726|NCT03811093|BG000|Baseline|Care as Usual Group|"A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Care as Usual Group: Each participant randomly assigned to the Care As Usual Group will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device."
11355727|NCT03811093|BG001|Baseline|Sham Group|"A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Sham Group: Each participant randomly assigned to the Sham Group will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device."
11355728|NCT03811093|BG002|Baseline|Total|Total of all reporting groups
11355729|NCT03811093|FG000|Participant Flow|Care as Usual Group|"A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular Low-level Laser Therapy (LLLT) protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Care as Usual Group: Each participant randomly assigned to the Care As Usual Group will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device."
11355730|NCT03811093|FG001|Participant Flow|Sham Group|"A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no Low-level Laser Light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Sham Group: Each participant randomly assigned to the Sham Group will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device."
11355731|NCT03811093|OG000|Outcome|Care as Usual Group|"A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Care as Usual Group: Each participant randomly assigned to the Care As Usual Group will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device."
11089802|NCT01525589|FG002|Participant Flow|Cohort B (Unselected)|"Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:~Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or~Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment."
11355732|NCT03811093|OG001|Outcome|Sham Group|"A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Sham Group: Each participant randomly assigned to the Sham Group will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device."
11355733|NCT03811093|OG000|Outcome|Care as Usual Group|"A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Care as Usual Group: Each participant randomly assigned to the Care As Usual Group will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device."
11355734|NCT03811093|OG000|Outcome|Care as Usual Group|"A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular Low-level Laser Therapy (LLLT) protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Care as Usual Group: Each participant randomly assigned to the Care As Usual Group will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device."
11355735|NCT03811093|OG001|Outcome|Sham Group|"A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no Low-level Laser Light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Sham Group: Each participant randomly assigned to the Sham Group will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device."
11355736|NCT03811093|EG000|Reported Event|Care as Usual Group|"A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Care as Usual Group: Each participant randomly assigned to the Care As Usual Group will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device."
11355737|NCT03811093|EG001|Reported Event|Sham Group|"A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.~Sham Group: Each participant randomly assigned to the Sham Group will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device."
11355738|NCT03822182|BG000|Baseline|Group 1 Control|"Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.~Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine."
11355739|NCT03822182|BG001|Baseline|Group 2|"Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline~liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:"
11355740|NCT03822182|BG002|Baseline|Group 3|"Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline~liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:~Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine."
11355741|NCT03822182|BG003|Baseline|Total|Total of all reporting groups
11355742|NCT03822182|FG000|Participant Flow|Control/Bupivicaine+DMSO|"Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.~Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine."
11355743|NCT03822182|FG001|Participant Flow|Liposomal Bupivicaine|"Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline~liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study."
11355744|NCT03822182|FG002|Participant Flow|Liposomal Bupivicaine + DMSO|"Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline~liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study."
11355745|NCT03822182|OG000|Outcome|Control/Bupivicaine+DMSO|"Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.~Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine."
11355746|NCT03822182|OG001|Outcome|Liposomal Bupivicaine|"Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline~liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:~Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline"
11355747|NCT03822182|OG002|Outcome|Liposomal Bupivicaine + DMSO|"Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline~liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:~Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline~Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard"
11355748|NCT03822182|OG002|Outcome|Liposomal Bupivicaine + DMSO|"Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline~There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:~Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline~Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine."
11355749|NCT03822182|EG000|Reported Event|Control/Bupivicaine +DMSO|"Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.~Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine."
11355750|NCT03822182|EG001|Reported Event|Liposomal Bupivicaine|"Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline~liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:~Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline"
11355751|NCT03822182|EG002|Reported Event|Liposomal Bupivicaine + DMS)|"Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline~The treatment groups are listed below:~Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline~Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard"
11355752|NCT03822416|BG000|Baseline|Intervention|"Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.~Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use~Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use~Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase~Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community"
11089803|NCT01525589|OG000|Outcome|Cohort A (BRCA+)|Patients with known deleterious BRCA1/2 mutation status at study entry
11355753|NCT03822416|BG001|Baseline|Control|"Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.~Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community"
11355754|NCT03822416|BG002|Baseline|Total|Total of all reporting groups
11355755|NCT03822416|FG000|Participant Flow|Intervention|"Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.~Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use~Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use~Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase~Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community"
11355756|NCT03822416|FG001|Participant Flow|Control|"Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.~Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community"
11355757|NCT03822416|OG000|Outcome|Intervention|"Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.~Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use~Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use~Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase~Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community"
11355758|NCT03822416|OG001|Outcome|Control|"Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.~Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community"
11355759|NCT03822416|EG000|Reported Event|Intervention|"Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.~Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use~Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use~Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase~Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community"
11355760|NCT03822416|EG001|Reported Event|Control|"Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.~Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community"
11355761|NCT03809104|BG000|Baseline|Elderly With Sarcopenia|"Virtual reality-based rehabilitation programs~Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer."
11355762|NCT03809104|FG000|Participant Flow|Elderly With Sarcopenia|"Virtual reality-based rehabilitation programs~Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer."
11355763|NCT03809104|OG000|Outcome|Elderly With Sarcopenia|"Virtual reality-based rehabilitation programs~Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer."
11357385|NCT03760796|OG000|Outcome|Corrie Digital Health Platform Group|Receives the Corrie Digital Health intervention plus the standard of care Corrie Digital Health platform: The Corrie Digital Health platform consists of the Corrie smartphone app for heart attack recovery which is paired with an Apple Watch and Bluetooth-enabled, iHealth blood pressure cuff. obtained from the literature.
11089804|NCT01525589|OG001|Outcome|Cohort A1 (BRCA+/PARPi)|Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
11355764|NCT03809104|EG000|Reported Event|Elderly With Sarcopenia|"Virtual reality-based rehabilitation programs~Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer."
11355765|NCT03807089|BG000|Baseline|Short-Turn Radius Colonoscope|"Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.~Short-Turn Radius Colonoscope"
11355766|NCT03807089|BG001|Baseline|Conventional Pediatric Colonoscope|"Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.~Conventional Pediatric Colonoscope"
11355767|NCT03807089|BG002|Baseline|Total|Total of all reporting groups
11355768|NCT03807089|FG000|Participant Flow|Short-Turn Radius Colonoscope|"Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.~Short-Turn Radius Colonoscope"
11355769|NCT03807089|FG001|Participant Flow|Conventional Pediatric Colonoscope|"Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.~Conventional Pediatric Colonoscope"
11355770|NCT03807089|OG000|Outcome|Short-Turn Radius Colonoscope|"Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.~Short-Turn Radius Colonoscope"
11355771|NCT03807089|OG001|Outcome|Conventional Pediatric Colonoscope|"Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.~Conventional Pediatric Colonoscope"
11355772|NCT03807089|EG000|Reported Event|Short-Turn Radius Colonoscope|"Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.~Short-Turn Radius Colonoscope"
11355773|NCT03807089|EG001|Reported Event|Conventional Pediatric Colonoscope|"Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.~Conventional Pediatric Colonoscope"
11355774|NCT03806231|BG000|Baseline|Outpatient Cervical Ripening|"Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.~Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction."
11355775|NCT03806231|BG001|Baseline|Inpatient Cervical Ripening|"The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.~Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized."
11169307|NCT01990794|OG000|Outcome|Female|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
11355776|NCT03806231|BG002|Baseline|Total|Total of all reporting groups
11357386|NCT03760796|EG000|Reported Event|Corrie Digital Health Platform Group|"Receives the Corrie Digital Health intervention plus the standard of care~Corrie Digital Health platform: The Corrie Digital Health platform consists of the Corrie smartphone app for heart attack recovery which is paired with an Apple Watch and Bluetooth-enabled, iHealth blood pressure cuff.~The sample size for reporting of adverse events is 216. 200 Corrie patients that finished the study plus 16 who were consented but later withdrew or were withdrawn from the study."
11355777|NCT03806231|FG000|Participant Flow|Outpatient Cervical Ripening|"Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.~Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction."
11355778|NCT03806231|FG001|Participant Flow|Inpatient Cervical Ripening|"The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.~Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized."
11355779|NCT03806231|OG000|Outcome|Outpatient Cervical Ripening|"Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.~Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction."
11355780|NCT03806231|OG001|Outcome|Inpatient Cervical Ripening|"The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.~Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized."
11355781|NCT03806231|EG000|Reported Event|Outpatient Cervical Ripening|"Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.~Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction."
11355782|NCT03806231|EG001|Reported Event|Inpatient Cervical Ripening|"The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.~Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized."
11355783|NCT03804710|BG000|Baseline|Treatment Regimen 1 (Test Product 1 + Standard Soap)|Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11357387|NCT03760640|BG000|Baseline|Sequence 1|"Participants received 100 units per milliliter (U/mL) of LY900014 or Humalog delivered via continuous subcutaneous insulin infusion (CSII) using the Medtronic MiniMed 670G insulin pump.~Period 1: LY900014 Period 2: Humalog"
11357388|NCT03760640|BG001|Baseline|Sequence 2|"Participants received 100 U/mL of LY900014 or Humalog delivered via CSII using the Medtronic MiniMed 670G insulin pump.~Period 1: Humalog Period 2: LY900014"
11357389|NCT03760640|BG002|Baseline|Total|Total of all reporting groups
11355784|NCT03804710|BG001|Baseline|Treatment Regimen 2 (Test Product 2 + Standard Soap)|Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants randomized to this treatment regimen and were further randomized within regimen left and right side. Participants applied allocated test product 2 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11355785|NCT03804710|BG002|Baseline|Total|Total of all reporting groups
11355786|NCT03804710|FG000|Participant Flow|Treatment Regimen 1 (Test Product 1 + Standard Soap)|Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 milliliter (mL) × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hours (hrs).
11355787|NCT03804710|FG001|Participant Flow|Treatment Regimen 2 (Test Product 2 + Standard Soap)|Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11355788|NCT03804710|OG000|Outcome|Test Product 1|Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11355789|NCT03804710|OG001|Outcome|Test Product 2|Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11355790|NCT03804710|OG002|Outcome|Standard Cleanser Soap|Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11169308|NCT01990794|OG001|Outcome|Male|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
11357390|NCT03760640|FG000|Participant Flow|Sequence 1|"Participants received 100 units per milliliter (U/mL) of LY900014 or Insulin lispro delivered via continuous subcutaneous insulin infusion (CSII) using the Medtronic MiniMed 670G insulin pump.~Period 1: LY900014 Period 2: Insulin Lispro (Humalog)"
11357391|NCT03760640|FG001|Participant Flow|Sequence 2|"Participants received 100 U/mL of LY900014 or Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.~Period 1: Insulin Lispro (Humalog) Period 2: LY900014"
11169309|NCT01990794|OG000|Outcome|Female WBC|WBC levels before, during and after dosing
11169310|NCT01990794|OG001|Outcome|Male WBC|WBC levels before, during, and after dosing
11355791|NCT03804710|EG000|Reported Event|Treatment Regimen 1 (Test Product 1 + Standard Soap)|Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11355792|NCT03804710|EG001|Reported Event|Treatment Regimen 2 (Test Product 2 + Standard Soap)|Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11355793|NCT03804710|EG002|Reported Event|Test Product 1|Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs
11355794|NCT03804710|EG003|Reported Event|Test Product 2|Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11355795|NCT03804710|EG004|Reported Event|Standard Soap|Participants applied standard cleanser soap (for cleansing purpose) topically before applying allocated either Test Product 1 or Test Product 2 to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
11355796|NCT03822377|BG000|Baseline|Ticagrelor Orodispersible Tablets|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.~Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva."
11355797|NCT03822377|BG001|Baseline|Ticagrelor Standard Tablets|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.~Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water."
11355798|NCT03822377|BG002|Baseline|Total|Total of all reporting groups
11355799|NCT03822377|FG000|Participant Flow|Ticagrelor Orodispersible Tablets|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.~Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva."
11355800|NCT03822377|FG001|Participant Flow|Ticagrelor Standard Tablets|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.~Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water."
11355801|NCT03822377|OG000|Outcome|Ticagrelor Orodispersible Tablets|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.~Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva."
11355802|NCT03822377|OG001|Outcome|Ticagrelor Standard Tablets|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.~Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water."
11355803|NCT03822377|OG000|Outcome|Experimental Arm|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.~Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva."
11355804|NCT03822377|OG001|Outcome|Control Arm|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.~Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water."
11355805|NCT03822377|EG000|Reported Event|Ticagrelor Orodispersible Tablets|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.~Ticagrelor orodispersible tablets: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva."
11169311|NCT01990794|OG000|Outcome|Female RBC|RBC levels before, during and after dosing
11169312|NCT01990794|OG001|Outcome|Male RBC|RBC levels before, during, and after dosing
11169313|NCT01990794|OG000|Outcome|Female Hematocrit|Hematocrit levels before, during and after dosing
11169314|NCT01990794|OG001|Outcome|Male Hematocrit|Hematocrit levels before, during, and after dosing
11232881|NCT02422186|FG000|Participant Flow|Intranasal Esketamine Plus Oral Antidepressant (AD)|Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg plus oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
11232882|NCT02422186|FG001|Participant Flow|Oral AD Plus Intranasal Placebo|Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day-Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day-Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day-Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day-Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo plus oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
11232883|NCT02422186|OG000|Outcome|Intranasal Esketamine Plus Oral Antidepressant (AD)|Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
11232884|NCT02422186|OG001|Outcome|Oral AD Plus Intranasal Placebo|Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
11232885|NCT02422186|EG000|Reported Event|DB Phase: Intranasal Esketamine + Oral AD (4 Weeks)|Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase.
11232886|NCT02422186|EG001|Reported Event|DB Phase: Oral AD + Intranasal Placebo (4 Weeks)|Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase.
11232887|NCT02422186|EG002|Reported Event|Follow-up Phase: Intranasal Esketamine + Oral AD (2 Weeks)|Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
11232888|NCT02422186|EG003|Reported Event|Follow-up Phase: Oral AD + Intranasal Placebo (2 Weeks)|Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
11232889|NCT02422264|BG000|Baseline|dTpa Group|Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
11357392|NCT03760640|OG000|Outcome|LY900014|Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.
11089805|NCT01525589|OG002|Outcome|Cohort B (Unselected)|"Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:~Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or~Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment."
11169315|NCT01990794|OG000|Outcome|Female Protein|Protein levels before, during and after dosing
11169316|NCT01990794|OG001|Outcome|Male Protein|Protein levels before, during, and after dosing
11169317|NCT01990794|OG000|Outcome|Female Albumin|Albumin levels before, during and after dosing
11169318|NCT01990794|OG001|Outcome|Male Albumin|Albumin levels before, during, and after dosing
11169319|NCT01990794|OG000|Outcome|Female TSH|TSH levels before, during and after dosing
11169320|NCT01990794|OG001|Outcome|Male TSH|TSH levels before, during, and after dosing
11169321|NCT01990794|OG000|Outcome|Female T4|T4 levels before, during and after dosing
11169322|NCT01990794|OG001|Outcome|Male T4|T4 levels before, during, and after dosing
11169323|NCT01990794|OG000|Outcome|Female Total Iron|Total iron levels before, during and after dosing
11169324|NCT01990794|OG001|Outcome|Male Total Iron|Total iron levels before, during, and after dosing
11169325|NCT01990794|OG000|Outcome|Female Ferritin|Ferritin levels before, during and after dosing
11169326|NCT01990794|OG001|Outcome|Male Ferritin|Ferritin levels before, during, and after dosing
11169327|NCT01990794|OG000|Outcome|Female CK-MB|CK-MB levels before, during and after dosing
11169328|NCT01990794|OG001|Outcome|Male CK-MB|CK-MB levels before, during, and after dosing
11169329|NCT01990794|OG000|Outcome|Female Creatine|Creatine levels before, during and after dosing
11169330|NCT01990794|OG001|Outcome|Male Creatine|Creatine levels before, during, and after dosing
11169331|NCT01990794|OG000|Outcome|Female ALT|ALT levels before, during and after dosing
11169332|NCT01990794|OG001|Outcome|Male ALT|ALT levels before, during, and after dosing
11169333|NCT01990794|OG000|Outcome|Female AST|AST levels before, during and after dosing
11169334|NCT01990794|OG001|Outcome|Male AST|AST levels before, during, and after dosing
11169335|NCT01990794|OG000|Outcome|Female HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
11169336|NCT01990794|OG001|Outcome|Male HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
11169337|NCT01990794|OG000|Outcome|Female Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
11169338|NCT01990794|OG001|Outcome|Male Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
11169339|NCT01990794|OG000|Outcome|Female Triglycerides|Triglyceride levels before and after cobalt supplementation
11169340|NCT01990794|OG001|Outcome|Male Triglycerides|Triglyceride levels before and after cobalt supplementation
11169341|NCT01990794|OG000|Outcome|Female Glucose|Glucose levels before, during and after dosing
11169342|NCT01990794|OG001|Outcome|Male Glucose|Glucose levels before, during, and after dosing
11169343|NCT01990794|OG000|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
11169344|NCT01990794|OG001|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
11169345|NCT01990794|OG000|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
11169346|NCT01990794|OG001|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
11169347|NCT01990794|OG000|Outcome|Female Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
11169348|NCT01990794|OG001|Outcome|Male Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
11169349|NCT01990794|OG000|Outcome|Prestudy - Right|Values of the right eye for select RNFL variables
11169350|NCT01990794|OG001|Outcome|Prestudy - Left|Values of the left eye for select RNFL variables
11169351|NCT01990794|OG002|Outcome|Study Midpoint - Right|Values of the right eye for select RNFL variables
11169352|NCT01990794|OG003|Outcome|Study Midpoint - Left|Values of the left eye for select RNFL variables
11169353|NCT01990794|OG004|Outcome|Study Completion - Right|Values of the right eye for select RNFL variables
11169354|NCT01990794|OG005|Outcome|Study Completion - Left|Values of the left eye for select RNFL variables
11169355|NCT01990794|OG000|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
11169356|NCT01990794|OG001|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
11169357|NCT01990794|OG002|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
11169358|NCT01990794|OG003|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
11169359|NCT01990794|OG004|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
11169360|NCT01990794|OG005|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
11169361|NCT01990794|OG000|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
11169362|NCT01990794|OG001|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
11169363|NCT01990794|OG002|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
11169364|NCT01990794|OG003|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
11169365|NCT01990794|OG004|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
11169366|NCT01990794|OG005|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
11169367|NCT01990794|OG003|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
11169368|NCT01990794|EG000|Reported Event|Study Volunteers|"Study volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
11357393|NCT03760640|OG001|Outcome|Insulin Lispro (Humalog)|Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
11355806|NCT03822377|EG001|Reported Event|Ticagrelor Standard Tablets|"STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.~Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.~Ticagrelor pills: Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water."
11355807|NCT03820388|BG000|Baseline|Propofol Group|"Propofol 2 mg/kg~Propofol 2mg/kg: 2 mg/kg"
11355808|NCT03820388|BG001|Baseline|Etomidate Group|"Etomidate 0.3 mg/kg~Etomidate 0.3 mg/kg: 0.3 mg/kg"
11355809|NCT03820388|BG002|Baseline|Propofol Plus Etomidate Group|"Propofol 1 mg/kg plus Etomidate 0.15 mg/kg~Propofol 1 mg/kg: 1 mg/kg Propofol~Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate"
11355810|NCT03820388|BG003|Baseline|Total|Total of all reporting groups
11355811|NCT03820388|FG000|Participant Flow|Propofol Group|"Propofol 2 mg/kg~Propofol 2mg/kg: 2 mg/kg"
11355812|NCT03820388|FG001|Participant Flow|Etomidate Group|"Etomidate 0.3 mg/kg~Etomidate 0.3 mg/kg: 0.3 mg/kg"
11355813|NCT03820388|FG002|Participant Flow|Propofol Plus Etomidate Group|"Propofol 1 mg/kg plus Etomidate 0.15 mg/kg~Propofol 1 mg/kg: 1 mg/kg Propofol~Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate"
11355814|NCT03820388|OG000|Outcome|Propofol Group|"Propofol 2 mg/kg~Propofol 2mg/kg: 2 mg/kg"
11355815|NCT03820388|OG001|Outcome|Etomidate Group|"Etomidate 0.3 mg/kg~Etomidate 0.3 mg/kg: 0.3 mg/kg"
11355816|NCT03820388|OG002|Outcome|Propofol Plus Etomidate Group|"Propofol 1 mg/kg plus Etomidate 0.15 mg/kg~Propofol 1 mg/kg: 1 mg/kg Propofol~Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate"
11355817|NCT03820388|EG000|Reported Event|Propofol Group|"Propofol 2 mg/kg~Propofol 2mg/kg: 2 mg/kg"
11355818|NCT03820388|EG001|Reported Event|Etomidate Group|"Etomidate 0.3 mg/kg~Etomidate 0.3 mg/kg: 0.3 mg/kg"
11355819|NCT03820388|EG002|Reported Event|Propofol Plus Etomidate Group|"Propofol 1 mg/kg plus Etomidate 0.15 mg/kg~Propofol 1 mg/kg: 1 mg/kg Propofol~Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate"
11355820|NCT03816696|BG000|Baseline|Dolutegravir/GSK3640254/Dolutegravir+GSK3640254|Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3.
11355821|NCT03816696|FG000|Participant Flow|Dolutegravir/GSK3640254/Dolutegravir+GSK3640254|Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3.
11355822|NCT03816696|OG000|Outcome|Dolutegravir 50 mg|In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
11174168|NCT02019979|BG000|Baseline|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
11355823|NCT03816696|OG000|Outcome|Dolutegravir 50 mg + GSK3640254 200 mg|In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
11355824|NCT03816696|OG000|Outcome|GSK3640254 200 mg|In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
11355825|NCT03816696|OG001|Outcome|GSK3640254 200 mg|In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
11355826|NCT03816696|OG002|Outcome|Dolutegravir 50 mg + GSK3640254 200 mg|In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
11355827|NCT03816696|EG000|Reported Event|Dolutegravir 50 mg|In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
11355828|NCT03816696|EG001|Reported Event|GSK3640254 200 mg|In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
11355829|NCT03816696|EG002|Reported Event|Dolutegravir 50 mg + GSK3640254 200 mg|In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
11355830|NCT03821064|BG000|Baseline|NDURE (Patient Navigation)|NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.
11357394|NCT03760640|EG000|Reported Event|LY900014|Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.
11357395|NCT03760640|EG001|Reported Event|Insulin Lispro (Humalog)|Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
11355831|NCT03821064|FG000|Participant Flow|NDURE (Patient Navigation)|NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.
11355832|NCT03821064|OG000|Outcome|Patient Navigation|Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.
11355833|NCT03821064|EG000|Reported Event|Patient Navigation|Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.
11355834|NCT03820544|BG000|Baseline|SEMS|"Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.~Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement"
11355835|NCT03820544|BG001|Baseline|Standard of Care Surgical Resection|"Patients undergo standard of care surgical resection.~Standard of care: Undergo standard of care surgical resection"
11355836|NCT03820544|BG002|Baseline|Total|Total of all reporting groups
11355837|NCT03820544|FG000|Participant Flow|SEMS|"Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.~Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement"
11355838|NCT03820544|FG001|Participant Flow|Standard of Care Surgical Resection|"Patients undergo standard of care surgical resection.~Standard of care: Undergo standard of care surgical resection"
11355839|NCT03820544|OG000|Outcome|SEMS|"Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.~Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement"
11355840|NCT03820544|OG001|Outcome|Standard of Care Surgical Resection|"Patients undergo standard of care surgical resection.~Standard of care: Undergo standard of care surgical resection"
11355841|NCT03820544|EG000|Reported Event|SEMS|"Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.~Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement"
11355842|NCT03820544|EG001|Reported Event|Standard of Care Surgical Resection|"Patients undergo standard of care surgical resection.~Standard of care: Undergo standard of care surgical resection"
11355843|NCT03820024|BG000|Baseline|Tailored Feedback Messages|"Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period.~Tailored Feedback Messages: Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period."
11355844|NCT03820024|BG001|Baseline|No Messages|No feedback messages
11355845|NCT03820024|BG002|Baseline|Total|Total of all reporting groups
11355846|NCT03820024|FG000|Participant Flow|Tailored Feedback Messages|"Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period.~Tailored Feedback Messages: Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period."
11355847|NCT03820024|FG001|Participant Flow|No Messages|No feedback messages
11355848|NCT03820024|OG000|Outcome|Tailored Feedback Messages|"Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period.~Tailored Feedback Messages: Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period."
11355849|NCT03820024|OG001|Outcome|No Messages|No feedback messages
11357396|NCT03760510|BG000|Baseline|Adhesive Tape|"Patients in adhesive tape arm had endotracheal tube secured with adhesive tape~Adhesive Tape: Endotracheal tube secured with adhesive tape."
11169369|NCT01990820|BG000|Baseline|Arm 1|"Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.~Adenoidectomy + Maxillary Sinus Irrigation: A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the maxillary sinuses will be entered via middle meati punctures using either a sterile spinal needle or a curved suction. Sinus contents will be aspirated and sent for aerobic/anaerobic cultures. Irrigation with 10ml of isotonic sodium chloride will be performed. If no material is aspirated initially, the sinus contents will be re-aspirated after irrigation and sent for aerobic/anaerobic cultures.~Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner.~After adequate hemostasis, the patient will be awakened and brought to the recovery room. Depending on the recovery, the child will either be admitted or discharged home."
11169370|NCT01990820|BG001|Baseline|Arm 2|"Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation~Acclarent Relieva Balloon Sinuplasty: A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the balloon catheter device will be inserted and the wire/balloon will be threaded through the maxillary sinus ostia. Confirmation of location will be per manufacturer's recommendation with either fluoroscopy or illumination. Following confirmation, the balloon will be dilated under visualization per manufacture's recommendation. After the visualization of the dilated ostia, cultures for aerobic/anerobic examination will be taken and irrigation with 10ml of isotonic sodium chloride will be performed.~Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner."
11169371|NCT01990820|BG002|Baseline|Total|Total of all reporting groups
11169372|NCT01990820|FG000|Participant Flow|Arm 1|"Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.~Adenoidectomy + Maxillary Sinus Irrigation: A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the maxillary sinuses will be entered via middle meati punctures using either a sterile spinal needle or a curved suction. Sinus contents will be aspirated and sent for aerobic/anaerobic cultures. Irrigation with 10ml of isotonic sodium chloride will be performed. If no material is aspirated initially, the sinus contents will be re-aspirated after irrigation and sent for aerobic/anaerobic cultures.~Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner.~After adequate hemostasis, the patient will be awakened and brought to the recovery room. Depending on the recovery, the child will either be admitted or discharged home."
11169373|NCT01990820|FG001|Participant Flow|Arm 2|"Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation~Acclarent Relieva Balloon Sinuplasty: A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the balloon catheter device will be inserted and the wire/balloon will be threaded through the maxillary sinus ostia. Confirmation of location will be per manufacturer's recommendation with either fluoroscopy or illumination. Following confirmation, the balloon will be dilated under visualization per manufacture's recommendation. After the visualization of the dilated ostia, cultures for aerobic/anerobic examination will be taken and irrigation with 10ml of isotonic sodium chloride will be performed.~Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner."
11169374|NCT01990820|OG000|Outcome|Adenoidectomy Without Balloon Dilation|Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.
11169375|NCT01990820|OG001|Outcome|Adenoidectomy With Balloon Dilation|Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation
11169376|NCT01990820|EG000|Reported Event|Arm 1|Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.
11169377|NCT01990820|EG001|Reported Event|Arm 2|Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation
11169378|NCT01990859|BG000|Baseline|Ipilimumab|Participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses.
11169379|NCT01990859|FG000|Participant Flow|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
11169380|NCT01990859|OG000|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
11169381|NCT01990859|OG000|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
11169382|NCT01990859|EG000|Reported Event|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
11169383|NCT01990898|BG000|Baseline|Treatment|Cyclosporine
11169384|NCT01990898|FG000|Participant Flow|Treatment|Cyclosporine
11169385|NCT01990898|OG000|Outcome|Treatment|Cyclosporine
11169386|NCT01990898|EG000|Reported Event|Treatment|Cyclosporine
11357397|NCT03760510|BG001|Baseline|Tube Fastener|"Patients in the tube fastener arm had endotrachel tube secured with tube fastener~Tube Fastener: Endotrachel tube secured with tube fastener"
11357398|NCT03760510|BG002|Baseline|Total|Total of all reporting groups
11357399|NCT03760510|FG000|Participant Flow|Adhesive Tape|"Patients in adhesive tape arm had endotracheal tube secured with adhesive tape~Adhesive Tape: Endotracheal tube secured with adhesive tape."
11232890|NCT02422264|BG001|Baseline|Control Group|Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
11232891|NCT02422264|BG002|Baseline|Total|Total of all reporting groups
11232892|NCT02422264|FG000|Participant Flow|dTpa Group|Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
11232893|NCT02422264|FG001|Participant Flow|Control Group|Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
11232894|NCT02422264|OG000|Outcome|dTpa Group|Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
11232895|NCT02422264|OG001|Outcome|Control Group|Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
11232896|NCT02422264|EG000|Reported Event|dTpa Group|Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
11232897|NCT02422264|EG001|Reported Event|Control Group|Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
11232898|NCT02422290|BG000|Baseline|Demographics|Demographics of participants
11232899|NCT02422290|FG000|Participant Flow|Adolescent OCD Ketamine Group|Open trial of ketamine IV for adolescents with treatment refractory OCD
11232900|NCT02422290|OG000|Outcome|Ketamine Treatment Group|Adolescents and young adults with OCD who received an intravenous ketamine infusion.
11232901|NCT02422290|EG000|Reported Event|Ketamine Treatment Group|Adolescents and young adults with OCD who received an intravenous ketamine infusion.
11232902|NCT02422511|BG000|Baseline|Well Baby Parents: Family History Only|"Parents of newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232903|NCT02422511|BG001|Baseline|Well Babies: Family History Only|"Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232904|NCT02422511|BG002|Baseline|Well Baby Parents: Family History + Exome Sequencing|"Parents of newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232905|NCT02422511|BG003|Baseline|Well Babies: Family History + Exome Sequencing|"Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232906|NCT02422511|BG004|Baseline|ICU Baby Parents: Family History Only|"Parents of newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11335577|NCT03552757|OG001|Outcome|Semaglutide 1.0 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
10888008|NCT00504257|OG000|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
11169387|NCT01990950|BG000|Baseline|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg. Additional ancillary components (main body extensions, iliac leg extensions, converters, and occluders) are available. The Zenith® Alignment Stent is a balloon-expandable stent that can be deployed through scallops or fenestrations in a Zenith® Fenestrated AAA Endovascular Graft into branch vessels of the aorta.
11169388|NCT01990950|FG000|Participant Flow|Zenith® Fenestrated AAA Endovascular Graft|Zenith® Fenestrated AAA Endovascular Graft: The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair
11169389|NCT01990950|OG000|Outcome|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg. Additional ancillary components (main body extensions, iliac leg extensions, converters, and occluders) are available. The Zenith® Alignment Stent is a balloon-expandable stent that can be deployed through scallops or fenestrations in a Zenith® Fenestrated AAA Endovascular Graft into branch vessels of the aorta
11169390|NCT01990950|EG000|Reported Event|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg.
11169391|NCT01991197|BG000|Baseline|Sitagliptin|"Double blind phase (week 0-16):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.~Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.~."
11169392|NCT01991197|BG001|Baseline|Gliclazide|"Double-blind phase (week 0-16):~Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.~Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.~."
11169393|NCT01991197|BG002|Baseline|Total|Total of all reporting groups
11169394|NCT01991197|FG000|Participant Flow|Sitagliptin|"Double blind phase (week 0-16):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.~Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks."
11169395|NCT01991197|FG001|Participant Flow|Gliclazide|"Double-blind phase (week 0-16):~Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.~Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks."
11169396|NCT01991197|OG000|Outcome|Sitagliptin|"Double blind phase (week 0-16):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.~Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks."
11169397|NCT01991197|OG001|Outcome|Gliclazide|"Double-blind phase (week 0-16):~Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.~Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks."
11169398|NCT01991197|OG001|Outcome|Gliclazide|"Double-blind phase (week 0-16):~Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.~Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.~Sitagliptin: Week 0-16: Two 50mg tablets (or one 50mg tablet for participants with moderate kidney disease) once daily for 16 weeks during the double-blind phase.~Week 16-32: Then two 50mg tablets (or one 50mg tablet for participants with moderate kidney disease) once daily for 16 weeks during the open-label phase of the trial."
11169399|NCT01991197|OG000|Outcome|Sitagliptin|
11169400|NCT01991197|OG001|Outcome|Gliclazide|
11169401|NCT01991197|OG000|Outcome|Gliclazide|
11169402|NCT01991197|OG001|Outcome|Sitagliptin|
11169403|NCT01991197|EG000|Reported Event|Sitagliptin|"Double blind phase (week 0-16):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.~Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks."
11232907|NCT02422511|BG005|Baseline|ICU Babies: Family History Only|"Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232908|NCT02422511|BG006|Baseline|ICU Baby Parents: Family History + Exome Sequencing|"Parents of newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232909|NCT02422511|BG007|Baseline|ICU Babies: Family History + Exome Sequencing|"Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232910|NCT02422511|BG008|Baseline|Total|Total of all reporting groups
11232911|NCT02422511|FG000|Participant Flow|Well Baby Parents: Family History Only|"Parents of newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report tand reviewed with all participants."
11232912|NCT02422511|FG001|Participant Flow|Well Babies: Family History Only|"Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report tand reviewed with all participants."
11232913|NCT02422511|FG002|Participant Flow|Well Baby Parents: Family History + Exome Sequencing|"Parents of newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled.~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232914|NCT02422511|FG003|Participant Flow|Well Babies: Family History + Exome Sequencing|"Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled.~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232915|NCT02422511|FG004|Participant Flow|ICU Baby Parents: Family History Only|"Parents of newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232916|NCT02422511|FG005|Participant Flow|ICU Babies: Family History Only|"Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232917|NCT02422511|FG006|Participant Flow|ICU Baby Parents: Family History + Exome Sequencing|"Parents of newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled.~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232918|NCT02422511|FG007|Participant Flow|ICU Babies: Family History + Exome Sequencing|"Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled.~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232919|NCT02422511|OG000|Outcome|Well Baby Family History Only|"Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232920|NCT02422511|OG001|Outcome|Well Baby Family History + Exome Sequencing|"Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232921|NCT02422511|OG002|Outcome|ICU Baby Family History Only|"Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232922|NCT02422511|OG003|Outcome|ICU Baby Family History + Exome Sequencing|"Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232923|NCT02422511|OG000|Outcome|Well Baby Family History Only|"Parents of newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232924|NCT02422511|OG001|Outcome|Well Baby Family History + Exome Sequencing|"Parents of newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232925|NCT02422511|OG002|Outcome|ICU Baby Family History Only|"Parents of newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232926|NCT02422511|OG003|Outcome|ICU Baby Family History + Exome Sequencing|"Parents of newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants."
11232927|NCT02422511|EG000|Reported Event|Well Baby Parents: Family History Only|"Parents of newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report tand reviewed with all participants."
11232928|NCT02422511|EG001|Reported Event|Well Babies: Family History Only|"Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report tand reviewed with all participants."
11232929|NCT02422511|EG002|Reported Event|Well Baby Parents: Family History + Exome Sequencing|"Parents of newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled.~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11357400|NCT03760510|FG001|Participant Flow|Tube Fastener|"Patients in the tube fastener arm had endotrachel tube secured with tube fastener~Tube Fastener: Endotrachel tube secured with tube fastener"
11357401|NCT03760510|OG000|Outcome|Adhesive Tape|"Patients in adhesive tape arm had endotracheal tube secured with adhesive tape~Adhesive Tape: Endotracheal tube secured with adhesive tape."
11089806|NCT01525589|EG000|Reported Event|Cohort A (BRCA+)|Patients with known deleterious BRCA1/2 mutation status at study entry
11355850|NCT03820024|EG000|Reported Event|Tailored Feedback Messages|"Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period.~Tailored Feedback Messages: Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period."
11355851|NCT03820024|EG001|Reported Event|No Messages|No feedback messages
11232930|NCT02422511|EG003|Reported Event|Well Babies: Family History + Exome Sequencing|"Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled.~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232931|NCT02422511|EG004|Reported Event|ICU Baby Parents: Family History Only|"Parents of newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232932|NCT02422511|EG005|Reported Event|ICU Babies: Family History Only|"Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232933|NCT02422511|EG006|Reported Event|ICU Baby Parents: Family History + Exome Sequencing|"Parents of newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled.~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232934|NCT02422511|EG007|Reported Event|ICU Babies: Family History + Exome Sequencing|"Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled.~Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.~Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants."
11232935|NCT02422940|BG000|Baseline|Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.~Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.~dalfampridine-ER 7.5 mg"
11232936|NCT02422940|BG001|Baseline|Dalfampridine-ER 10 mg|"Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.~Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.~dalfampridine-ER 10 mg"
11232937|NCT02422940|BG002|Baseline|Total|Total of all reporting groups
11232938|NCT02422940|FG000|Participant Flow|Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.~Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.~dalfampridine-ER 7.5 mg"
11232939|NCT02422940|FG001|Participant Flow|Dalfampridine-ER 10 mg|"Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.~Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.~dalfampridine-ER 10 mg"
11232940|NCT02422940|OG000|Outcome|Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.~Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.~dalfampridine-ER 7.5 mg"
11232941|NCT02422940|OG001|Outcome|Dalfampridine-ER 10 mg|"Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.~Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.~dalfampridine-ER 10 mg"
11355852|NCT03807544|BG000|Baseline|TENS Treatment Arm|"This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.~TENS: Transcutaneous electrical nerve stimulation"
11355853|NCT03807544|FG000|Participant Flow|TENS Treatment Arm|This study is a usability study, where all subjects will receive the same experimental treatment (both palms and wrists) for their single visit. TENS: Transcutaneous electrical nerve stimulation
11355854|NCT03807544|OG000|Outcome|TENS Location - Palm|Measuring SNAP/Tingling off of the Palm location (active treatment site)
11355855|NCT03807544|OG001|Outcome|TENS Location - Wrist|Measuring SNAP/Tingling off of the Wrist location (active treatment site)
11355856|NCT03807544|EG000|Reported Event|TENS Treatment Arm|"This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.~TENS: Transcutaneous electrical nerve stimulation"
11355857|NCT03809182|BG000|Baseline|Dexmedetomidine|"After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.~Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.~Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room."
11355858|NCT03809182|BG001|Baseline|0.9% Sodium-chloride|"After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.~0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).~Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room."
11355859|NCT03809182|BG002|Baseline|Total|Total of all reporting groups
11355860|NCT03809182|FG000|Participant Flow|Dexmedetomidine|"After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:~Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.~Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room."
11355861|NCT03809182|FG001|Participant Flow|0.9% Sodium-chloride|"After anesthesia induction, patients who were randomized to the Placebo group received:~0.9% Sodium-chloride: The same bolus and infusion rate used in the dexmedetomidine group.~Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room."
11355862|NCT03809182|OG000|Outcome|Dexmedetomidine|"After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:~Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.~Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room."
11355863|NCT03809182|OG001|Outcome|0.9% Sodium-chloride|"After anesthesia induction, patients who were randomized to the Placebo group received:~0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).~Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room."
11355864|NCT03809182|OG000|Outcome|Dexmedetomidine|"After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.~Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.~Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room."
11355865|NCT03809182|OG001|Outcome|0.9% Sodium-chloride|"After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.~0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).~Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room."
11357402|NCT03760510|OG001|Outcome|Tube Fastener|"Patients in the tube fastener arm had endotrachel tube secured with tube fastener~Tube Fastener: Endotrachel tube secured with tube fastener"
11089807|NCT01525589|EG001|Reported Event|Cohort A1 (BRCA+/PARPi)|Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
11355866|NCT03809182|EG000|Reported Event|Dexmedetomidine|"After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.~Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.~Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room."
11355867|NCT03809182|EG001|Reported Event|0.9% Sodium-chloride|"After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.~0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).~Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).~Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room."
11355868|NCT03816761|BG000|Baseline|Cohort 1|Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355869|NCT03816761|BG001|Baseline|Cohort 2|Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355870|NCT03816761|BG002|Baseline|Cohort 3|Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355871|NCT03816761|BG003|Baseline|Total|Total of all reporting groups
11355872|NCT03816761|FG000|Participant Flow|Cohort 1: t65 First, Then t50|iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. The total treatment duration for each cohort was 14 days.
11355873|NCT03816761|FG001|Participant Flow|Cohort 1: t50 First, Then t65|iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days.
11355874|NCT03816761|FG002|Participant Flow|Cohort 2: t65 First, Then t40|iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. The total treatment duration for each cohort was 14 days.
11355875|NCT03816761|FG003|Participant Flow|Cohort 2: t40 First, Then t65|iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days.
11355876|NCT03816761|FG004|Participant Flow|Cohort 3: t65 First, Then t30|iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. The total treatment duration for each cohort was 14 days.
11089808|NCT01525589|EG002|Reported Event|Cohort B (Unselected)|"Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:~Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or~Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment."
11355877|NCT03816761|FG005|Participant Flow|Cohort 3: t30 First, Then t65|iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days.
11355878|NCT03816761|OG000|Outcome|t50 Faster Aspart Cohort 1|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355879|NCT03816761|OG001|Outcome|t65 Faster Aspart Cohort 1|Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355880|NCT03816761|OG002|Outcome|t40 Faster Aspart Cohort 2|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355881|NCT03816761|OG003|Outcome|t65 Faster Aspart Cohort 2|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355882|NCT03816761|OG004|Outcome|t30 Faster Aspart Cohort 3|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355883|NCT03816761|OG005|Outcome|t65 Faster Aspart Cohort 3|Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355884|NCT03816761|OG000|Outcome|t50 Faster Aspart Cohort 2|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355885|NCT03816761|OG002|Outcome|t40 Faster Aspart Cohort 1|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355886|NCT03816761|OG000|Outcome|t65 Faster Aspart Cohort 1|Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355887|NCT03816761|OG001|Outcome|t50 Faster Aspart Cohort 1|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355888|NCT03816761|OG002|Outcome|t65 Faster Aspart Cohort 2|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355889|NCT03816761|OG003|Outcome|t40 Faster Aspart Cohort 2|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355890|NCT03816761|OG004|Outcome|t65 Faster Aspart Cohort 3|Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355891|NCT03816761|OG005|Outcome|t30 Faster Aspart Cohort 3|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355892|NCT03816761|EG000|Reported Event|t50 Faster Aspart Cohort 1|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355893|NCT03816761|EG001|Reported Event|t65 Faster Aspart Cohort 1|Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355894|NCT03816761|EG002|Reported Event|t40 Faster Aspart Cohort 2|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355895|NCT03816761|EG003|Reported Event|t65 Faster Aspart Cohort 2|Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11355896|NCT03816761|EG004|Reported Event|t30 Faster Aspart Cohort 3|Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11357403|NCT03760510|EG000|Reported Event|Adhesive Tape|"Patients in adhesive tape arm had endotracheal tube secured with adhesive tape~Adhesive Tape: Endotracheal tube secured with adhesive tape."
11089809|NCT01525602|BG000|Baseline|Part 1: Cohort 1; 600 mg/Day|Participants with advanced solid tumors who received PLX3397 600 mg/day.
11355897|NCT03816761|EG005|Reported Event|t65 Faster Aspart Cohort 3|Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days.
11357404|NCT03760510|EG001|Reported Event|Tube Fastener|"Patients in the tube fastener arm had endotrachel tube secured with tube fastener~Tube Fastener: Endotrachel tube secured with tube fastener"
11357405|NCT03760250|BG000|Baseline|Imiquimod|"5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision~Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision"
11357406|NCT03760250|FG000|Participant Flow|Imiquimod|"5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision~Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision"
11357407|NCT03760250|OG000|Outcome|Imiquimod|"5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision~Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision"
11357408|NCT03760250|EG000|Reported Event|Imiquimod|"5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision~Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision"
11357409|NCT03759600|BG000|Baseline|Niraparib 300 mg|Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.
11357410|NCT03759600|FG000|Participant Flow|Niraparib 300 mg|Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.
11357411|NCT03759600|OG000|Outcome|Niraparib 300 mg|Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.
11357412|NCT03759600|EG000|Reported Event|Niraparib 300 mg|Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.
11357413|NCT03759340|BG000|Baseline|ATI 502 0.46% Topical Solution|"Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.~ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)"
11357414|NCT03759340|FG000|Participant Flow|ATI-502 0.46% Topical Solution|"Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.~ATI-502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)."
11357415|NCT03759340|OG000|Outcome|ATI 502 0.46% Topical Solution|"Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.~ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)"
11357416|NCT03759340|EG000|Reported Event|ATI 502 0.46% Topical Solution|"Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.~ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)"
11357417|NCT03758716|BG000|Baseline|FB825|"Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.~FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV"
11357418|NCT03758716|FG000|Participant Flow|FB825|"Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.~FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV"
11357419|NCT03758716|OG000|Outcome|FB825|"Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.~FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV"
11357420|NCT03758716|EG000|Reported Event|FB825|"Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.~FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV"
11357421|NCT03758365|BG000|Baseline|MC2-01 Cream + Comparators|"Single application of 7 different treatments, where different sections on the arm was randomized to the following interventions:~- MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream~- Clobetasol Propionate 0.05% Lotion~- Betamethasone Dipropionate 0.05% Cream~- Triamcinolone Acetonide 0.1% Cream~- Hydrocortisone Butyrate 0.1% Cream~- Desonide 0.05% Cream~- Vehicle Cream~to perform visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11357422|NCT03758365|FG000|Participant Flow|MC2-01 Cream + Comparators|"Single application of 7 different treatments, where different sections on the arm was randomized to the following interventions:~- MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream~- Clobetasol Propionate 0.05% Lotion~- Betamethasone Dipropionate 0.05% Cream~- Triamcinolone Acetonide 0.1% Cream~- Hydrocortisone Butyrate 0.1% Cream~- Desonide 0.05% Cream~- Vehicle Cream~to perform visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11357423|NCT03758365|OG000|Outcome|MC2-01 Cream + Comparators|"Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream~MC2-01 Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11357424|NCT03758365|OG000|Outcome|MC2-01 Cream + Comparators|"Single application of 7 different treatments, where different sections on the arm was randomized to the following interventions:~- MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream~- Clobetasol Propionate 0.05% Lotion~- Betamethasone Dipropionate 0.05% Cream~- Triamcinolone Acetonide 0.1% Cream~- Hydrocortisone Butyrate 0.1% Cream~- Desonide 0.05% Cream~- Vehicle Cream~to perform visual evaluation of local tolerability, physical examination and safety evaluation"
11089810|NCT01525602|BG001|Baseline|Part 1: Cohort 2; 800 mg/Day|Participants with advanced solid tumors who received PLX3397 800 mg/day.
11355898|NCT03801044|BG000|Baseline|PD Patients|"21 PD patients treated in out unit were enrolled.~NT-BNP, VEGF: VEGF-C levels were measured in the serum samples. R&D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics).~Echocardiography: Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography~Chest Radiography: All radiographies were taken when the patient was standing erect position during deep inhalation. They"
11355899|NCT03801044|FG000|Participant Flow|PD Patients|"21 PD patients treated in out unit were enrolled.~NT-BNP, VEGF: VEGF-C levels were measured in the serum samples. R&D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics).~Echocardiography: Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography~Chest Radiography: All radiographies were taken when the patient was standing erect position during deep inhalation. They"
11355900|NCT03801044|OG000|Outcome|PD Patients|21 PD patients treated in out unit were enrolled.
11355901|NCT03801044|OG000|Outcome|PD Patients|All PD patients except for two patients who were immobile to adhere to diagnostic tests (n=21).
11355902|NCT03801044|OG000|Outcome|PD Patients|All PD patients except two patients who were immobile for adhering to diagnostic tests.
11355903|NCT03801044|OG000|Outcome|PD Patients|PD patients (n=21)
11355904|NCT03801044|OG000|Outcome|PD Patients|PD Patients (n=21)
11355905|NCT03801044|EG000|Reported Event|PD Patients|21 PD patients treated in out unit were enrolled.
11355906|NCT03805672|BG000|Baseline|Low Dose Enoxaparin|"Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.~Low Dose Enoxaparin"
11355907|NCT03805672|BG001|Baseline|High Dose Enoxaparin|"Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.~High Dose Enoxaparin"
11355908|NCT03805672|BG002|Baseline|Total|Total of all reporting groups
11355909|NCT03805672|FG000|Participant Flow|Low Dose Enoxaparin|"Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.~Low Dose Enoxaparin"
11355910|NCT03805672|FG001|Participant Flow|High Dose Enoxaparin|"Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.~High Dose Enoxaparin"
11355911|NCT03805672|OG000|Outcome|Low Dose Enoxaparin|"Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.~Low Dose Enoxaparin"
11355912|NCT03805672|OG001|Outcome|High Dose Enoxaparin|"Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.~High Dose Enoxaparin"
11355913|NCT03805672|EG000|Reported Event|Low Dose Enoxaparin|"Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.~Low Dose Enoxaparin"
11355914|NCT03805672|EG001|Reported Event|High Dose Enoxaparin|"Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.~High Dose Enoxaparin"
11355915|NCT03808493|BG000|Baseline|Pilot BE Study 1, Sequence A: TAK-438 OD 20 mg + TAK-438 20 mg|TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 2.
11355916|NCT03808493|BG001|Baseline|Pilot BE Study 1, Sequence B: TAK-438 20 mg + TAK-438 OD 20 mg|TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1 followed by a washout period of at least 7 days, further followed TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of Period 2.
11355917|NCT03808493|BG002|Baseline|Pilot BE Study 2, Sequence C: TAK-438 OD 20 mg + TAK-438 20 mg|TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 20 mg tablet, orally with water under fasted condition, once on Day 1 of Period 2.
11355918|NCT03808493|BG003|Baseline|Pilot BE Study 2, Sequence D: TAK-438 20 mg + TAK-438 OD 20 mg|TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 OD 20 mg tablet, orally with water under fasted condition, once on Day 1 of Period 2.
11355919|NCT03808493|BG004|Baseline|Total|Total of all reporting groups
11355920|NCT03808493|FG000|Participant Flow|Pilot BE Study 1, Sequence A: TAK-438 OD 20 mg + TAK-438 20 mg|TAK-438 orally disintegrating (OD) 20 mg, tablet, orally without water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 2.
11355921|NCT03808493|FG001|Participant Flow|Pilot BE Study 1, Sequence B: TAK-438 20 mg + TAK-438 OD 20 mg|TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1 followed by a washout period of at least 7 days, further followed TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of Period 2.
11355922|NCT03808493|FG002|Participant Flow|Pilot BE Study 2, Sequence C: TAK-438 OD 20 mg + TAK-438 20 mg|TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 20 mg tablet, orally with water under fasted condition, once on Day 1 of Period 2.
11169404|NCT01991197|EG001|Reported Event|Gliclazide|"Double-blind phase (week 0-16):~Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.~Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks."
11169405|NCT01991314|BG000|Baseline|Adolescent - Ferrous Sulphate|45 adolescents (age 13-18 years) given oral ferrous sulphate 200mg bd for 6 weeks
11169406|NCT01991314|BG001|Baseline|Adults - Ferrous Sulphate|43 adults (age >18 years) given oral ferrous sulphate 200mg bd for 6 weeks
11169407|NCT01991314|BG002|Baseline|Total|Total of all reporting groups
11355923|NCT03808493|FG003|Participant Flow|Pilot BE Study 2, Sequence D: TAK-438 20 mg + TAK-438 OD 20 mg|TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 OD 20 mg tablet, orally with water under fasted condition, once on Day 1 of Period 2.
11169408|NCT01991314|FG000|Participant Flow|Adolescents - Ferrous Sulphate|45 adolescents (13-18 years) given ferrous sulphate 200mg bd for 6 weeks
11169409|NCT01991314|FG001|Participant Flow|Adults - Ferrous Sulphate|43 adults (>18 years) given ferrous sulphate 200mg bd for 6 weeks
11169410|NCT01991314|OG000|Outcome|Adolescents|Patients aged 13 - 18 years
11355924|NCT03808493|OG000|Outcome|Pilot BE Study 1: TAK-438 OD 20 mg|TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2.
11169411|NCT01991314|OG001|Outcome|Adults|IBD patients aged >18
11169412|NCT01991314|EG000|Reported Event|Adolescents|Patients aged 13 - 18 years
11169413|NCT01991314|EG001|Reported Event|Adults|IBD patients aged >18
11169414|NCT01991470|BG000|Baseline|2-18 Year Olds Wearing Enlite Sensor|2-18 years old wearing Enlite and/or Enlite3 sensors.
11169415|NCT01991470|FG000|Participant Flow|2-18 Years Old Wearing Sensors|2-18 years old wearing Enlite and/or Enlite3 sensors.
11169416|NCT01991470|OG000|Outcome|Enlite Sensor Accuracy MARD, Lower Serial Number|Enlite Sensor accuracy relative to the YSI reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days were pooled together for reporting purpose.
11169417|NCT01991470|OG000|Outcome|Enlite 3 Sensor Accuracy MARD, Guardian Mobile|Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.
11169418|NCT01991470|OG000|Outcome|Enlite 3 Sensor Accuracy MARD,GST 3C|Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.
11169419|NCT01991470|OG000|Outcome|Enlite Sensor Accuracy MARD, Higher Serial Number|Enlite Sensor accuracy relative to the YSI reference. Each subject wore two 530G pumps. The results for the higher serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the secondary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.
11169420|NCT01991470|OG000|Outcome|Enlite Sensor Accuracy MARD, Lower Serial Number|Enlite Sensor accuracy using two 530G pumps and two REAL-Time transmitters with one additional calibration during FST will be evaluated and report separately (e.g., lower serial number and high serial number)Enlite sensor values will be compared to Yellow Spring Instruments (YSI) plasma glucose values during Frequent Sample Testing in the Enlite phase. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
11169421|NCT01991470|OG000|Outcome|Enlite Sensor Accuracy MARD, Higher Serial Number|Enlite Sensor accuracy using two 530G pumps and two REAL-Time transmitters with one additional calibration during FST will be evaluated and report separately (e.g., lower serial number and high serial number) Enlite sensor values will be compared to Yellow Spring Instruments (YSI) plasma glucose values during Frequent Sample Testing in the Enlite phase. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
11174169|NCT02019979|FG000|Participant Flow|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
11355925|NCT03808493|OG001|Outcome|Pilot BE Study 1: TAK-438 20 mg|TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
11355926|NCT03808493|OG002|Outcome|Pilot BE Study 2: TAK-438 OD 20 mg|TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
11169422|NCT01991470|OG000|Outcome|Enlite 3 MARD, Guardian Mobile, One Additional Fingerstick|Enlite 3 Sensor accuracy using, (1) Guardian Mobile System (2) GST 3C transmitter, with one additional calibration during FST will be evaluated and report. Enlite 3 sensor values will be compared to Yellow Spring Instruments (YSI) plasma glucose values during Frequent Sample Testing in the Enlite 3 phase. For subjects 2-6 years of age, SMBG may be used as a reference value. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
11169423|NCT01991470|OG000|Outcome|Enlite 3 MARD,GST 3C, One Additional Fingerstick|Enlite 3 Sensor accuracy using, (1) Guardian Mobile System (2) GST 3C transmitter, with one additional calibration during FST will be evaluated and report. Enlite 3 sensor values will be compared to Yellow Spring Instruments (YSI) plasma glucose values during Frequent Sample Testing in the Enlite 3 phase. For subjects 2-6 years of age, SMBG may be used as a reference value. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
11169424|NCT01991470|EG000|Reported Event|2-18 Year Olds Wearing Enlite Sensors|2-18 year olds wearing Enlite Sensors
11169425|NCT01991470|EG001|Reported Event|2-18 Year Olds Wearing Enlite3 Sensors|2-18 year olds wearing Enlite3 Sensors
11169426|NCT01991483|BG000|Baseline|Placebo|Placebo administered IV Q2W for six weeks (three doses).
11169427|NCT01991483|BG001|Baseline|300 mg LY2928057|300 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169428|NCT01991483|BG002|Baseline|600 mg LY2928057|600 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169429|NCT01991483|BG003|Baseline|1000 mg LY2928057|1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169430|NCT01991483|BG004|Baseline|Total|Total of all reporting groups
11169431|NCT01991483|FG000|Participant Flow|Placebo|Placebo administered intravenously (IV) once every two weeks (Q2W) for six weeks (three doses).
11169432|NCT01991483|FG001|Participant Flow|300 mg LY2928057|300 milligrams (mg) LY2928057 administered IV Q2W for six weeks (three doses).
11169433|NCT01991483|FG002|Participant Flow|600 mg LY2928057|600 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169434|NCT01991483|FG003|Participant Flow|1000 mg LY2928057|1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169435|NCT01991483|OG000|Outcome|Placebo|Placebo administered IV Q2W for six weeks (three doses).
11169436|NCT01991483|OG001|Outcome|300 mg LY2928057|300 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169437|NCT01991483|OG002|Outcome|600 mg LY2928057|600 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169438|NCT01991483|OG003|Outcome|1000 mg LY2928057|1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169439|NCT01991483|OG000|Outcome|300 mg LY2928057|300 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169440|NCT01991483|OG001|Outcome|600 mg LY2928057|600 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169441|NCT01991483|OG002|Outcome|1000 mg LY2928057|1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169442|NCT01991483|EG000|Reported Event|Placebo|Placebo administered IV Q2W for six weeks (three doses).
11169443|NCT01991483|EG001|Reported Event|300 mg LY2928057|300 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169444|NCT01991483|EG002|Reported Event|600 mg LY2928057|600 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169445|NCT01991483|EG003|Reported Event|1000 mg LY2928057|1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
11169446|NCT01991522|BG000|Baseline|Curriculum Group|The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists.
11169447|NCT01991522|BG001|Baseline|Self-directed Learning Group|The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
11169448|NCT01991522|BG002|Baseline|Total|Total of all reporting groups
11169449|NCT01991522|FG000|Participant Flow|Curriculum Group|The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists.
11169450|NCT01991522|FG001|Participant Flow|Self-directed Learning Group|The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
11169451|NCT01991522|OG000|Outcome|Curriculum Group|The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists.
11169452|NCT01991522|OG001|Outcome|Self-directed Learning Group|The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
11169453|NCT01991522|EG000|Reported Event|Curriculum Group|The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists.
11169454|NCT01991522|EG001|Reported Event|Self-directed Learning Group|The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
11169455|NCT01991548|BG000|Baseline|Insulin Dependent Diabetics|individuals with insulin dependant diabetes using the 640G insulin pump for insulin infusion and continuous glucose monitoring
11169456|NCT01991548|FG000|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 640G insulin pump and Guardian Link transmitter.
11355927|NCT03808493|OG003|Outcome|Pilot BE Study 2: TAK-438 20 mg|TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
11089811|NCT01525602|BG002|Baseline|Part 1: Cohort 3; 1000 mg/Day|Participants with advanced solid tumors who received PLX3397 1000 mg/day.
11355928|NCT03808493|EG000|Reported Event|Pilot BE Study 1: TAK-438 OD 20 mg|TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2.
11355929|NCT03808493|EG001|Reported Event|Pilot BE Study 1: TAK-438 20 mg|TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
11089812|NCT01525602|BG003|Baseline|Part 1: Cohort 4; 1200 mg/Day|Participants with advanced solid tumors who received PLX3397 1200 mg/day.
11089813|NCT01525602|BG004|Baseline|Part 1 and 2: Cohort 5; 1600 mg/Day|Participants with advanced solid tumors who received PLX3397 1600 mg/day.
11089814|NCT01525602|BG005|Baseline|Part 3: PLX3397 600 mg BID|All participants with advanced solid tumors who received PLX3397 600 mg BID as Cycle 1 lead-in treatment. After Cycle 1, participants were treated with PLX3397 600 mg BID and paclitaxel 80 mg/m^2 IV weekly.
11089815|NCT01525602|BG006|Baseline|Part 3: Paclitaxel 80 mg/m^2|All participants with advanced solid tumors who received paclitaxel 80 mg/m^2 intravenous weekly as Cycle 1 lead-in treatment. After Cycle 1, participants were treated with PLX3397 600 mg BID and paclitaxel 80 mg/m^2 IV weekly.
11089816|NCT01525602|BG007|Baseline|Part 3: PLX3397 600 mg + Paclitaxel 80 mg/m^2|All participants who received PLX3397 600 mg BID + paclitaxel 80 mg/m^2 intravenous weekly as Cycle 1 lead-in treatment.
11089817|NCT01525602|BG008|Baseline|Total|Total of all reporting groups
11089818|NCT01525602|FG000|Participant Flow|Part 1: Cohort 1; 600 mg/Day|Participants with advanced solid tumors who received PLX3397 600 mg/day.
11089819|NCT01525602|FG001|Participant Flow|Part 1: Cohort 2; 800 mg/Day|Participants with advanced solid tumors who received PLX3397 800 mg/day.
11089820|NCT01525602|FG002|Participant Flow|Part 1: Cohort 3; 1000 mg/Day|Participants with advanced solid tumors who received PLX3397 1000 mg/day.
11089821|NCT01525602|FG003|Participant Flow|Part 1: Cohort 4; 1200 mg/Day|Participants with advanced solid tumors who received PLX3397 1200 mg/day.
11089822|NCT01525602|FG004|Participant Flow|Part 1 and 2: Cohort 5; 1600 mg/Day|Participants with advanced solid tumors who received PLX3397 1600 mg/day.
11089823|NCT01525602|FG005|Participant Flow|Part 3: PLX3397 600 mg BID|All participants with advanced solid tumors who received PLX3397 600 mg twice daily (BID) as Cycle 1 lead-in treatment. After Cycle 1, participants were treated with PLX3397 600 mg BID and paclitaxel 80 mg/m^2 IV weekly.
11089824|NCT01525602|FG006|Participant Flow|Part 3: Paclitaxel 80 mg/m^2|All participants with advanced solid tumors who received paclitaxel 80 mg/m^2 intravenous weekly as Cycle 1 lead-in treatment. After Cycle 1, participants were treated with PLX3397 600 mg twice daily (BID) and paclitaxel 80 mg/m^2 IV weekly.
11089825|NCT01525602|FG007|Participant Flow|Part 3: PLX3397 600 mg + Paclitaxel 80 mg/m^2|All participants who received PLX3397 600 mg twice daily (BID) + paclitaxel 80 mg/m^2 intravenous weekly as Cycle 1 lead-in treatment.
11089826|NCT01525602|OG000|Outcome|Part 1: Cohort 1; 600 mg/Day|Participants with advanced solid tumors who received PLX3397 600 mg/day.
11089827|NCT01525602|OG001|Outcome|Part 1: Cohort 2; 800 mg/Day|Participants with advanced solid tumors who received PLX3397 800 mg/day.
11089828|NCT01525602|OG002|Outcome|Part 1: Cohort 3; 1000 mg/Day|Participants with advanced solid tumors who received PLX3397 1000 mg/day.
11089829|NCT01525602|OG003|Outcome|Part 1: Cohort 4; 1200 mg/Day|Participants with advanced solid tumors who received PLX3397 1200 mg/day.
11089830|NCT01525602|OG004|Outcome|Part 1 and 2: Cohort 5; 1600 mg/Day|Participants with advanced solid tumors who received PLX3397 1600 mg/day.
11089831|NCT01525602|OG000|Outcome|Part 3: PLX3397 600 mg BID|All participants with advanced solid tumors who received PLX3397 600 mg BID as Cycle 1 lead-in treatment. After Cycle 1, participants were treated with PLX3397 600 mg BID and paclitaxel 80 mg/m^2 IV weekly.
11089832|NCT01525602|OG001|Outcome|Part 3: Paclitaxel 80 mg/m^2|All participants with advanced solid tumors who received paclitaxel 80 mg/m^2 intravenous weekly as Cycle 1 lead-in treatment. After Cycle 1, participants were treated with PLX3397 600 mg BID and paclitaxel 80 mg/m^2 IV weekly.
11089833|NCT01525602|OG002|Outcome|Part 3: PLX3397 600 mg + Paclitaxel 80 mg/m^2|All participants who received PLX3397 600 mg BID + paclitaxel 80 mg/m^2 intravenous weekly as Cycle 1 lead-in treatment.
11089834|NCT01525602|OG002|Outcome|Part 3: PLX3397 600 mg BID + Paclitaxel 80 mg/m^2|All participants who received PLX3397 600 mg BID + paclitaxel 80 mg/m^2 intravenous weekly as Cycle 1 lead-in treatment.
11089835|NCT01525602|OG000|Outcome|Part 1: 600 mg BID|Participants with advanced solid tumors who received PLX3397 600 mg BID administered as three 100-mg capsules in the morning and evening, or two 200-mg capsules in the morning and one 200-mg capsule in the evening.
11089836|NCT01525602|OG001|Outcome|Part 1: 800 mg (400 mg BID)|Participants with advanced solid tumors who received PLX3397 800 mg administered 400 mg BID.
11089837|NCT01525602|OG002|Outcome|Part 1: 1000 mg (BID)|Participants with advanced solid tumors who received PLX3397 1000 mg BID administered as five 100-mg capsules in the morning and evening, or three 200-mg capsules in the morning and two 200-mg capsules in the evening.
11089838|NCT01525602|OG003|Outcome|Part 1: 1200 mg (600 mg BID)|Participants with advanced solid tumors who received PLX3397 1200 mg administered 600 mg BID.
11089839|NCT01525602|OG004|Outcome|Part 1 and 2: 1600 mg (800 mg BID)|Participants with advanced solid tumors who received PLX3397 1600 mg administered 800 mg BID.
11089840|NCT01525602|OG005|Outcome|Part 3: 1200 mg (600 mg BID)|Participants with advanced solid tumors who received PLX3397 1200 mg administered 600 mg BID.
11089841|NCT01525602|EG000|Reported Event|Part 1: Cohort 1; 600 mg/Day|Participants with advanced solid tumors who received PLX3397 600 mg/day.
11089842|NCT01525602|EG001|Reported Event|Part 1: Cohort 2; 800 mg/Day|Participants with advanced solid tumors who received PLX3397 800 mg/day.
11089843|NCT01525602|EG002|Reported Event|Part 1: Cohort 3; 1000 mg/Day|Participants with advanced solid tumors who received PLX3397 1000 mg/day.
11089844|NCT01525602|EG003|Reported Event|Part 1: Cohort 4; 1200 mg/Day|Participants with advanced solid tumors who received PLX3397 1200 mg/day.
11089845|NCT01525602|EG004|Reported Event|Part 1 and 2: Cohort 5; 1600 mg/Day|Participants with advanced solid tumors who received PLX3397 1600 mg/day.
11169457|NCT01991548|OG000|Outcome|Overall|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
11169458|NCT01991548|EG000|Reported Event|Overall|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
11169459|NCT01991743|BG000|Baseline|Drug:Group 2.5|"Administration of 2.5 mg bupivacaine~Group 2.5: Administration of bupivacaine 2.5 mg."
11169460|NCT01991743|BG001|Baseline|Group 5|"Administration of 5 mg bupivacaine.~Group 5: Administration of 5 mg bupivacaine"
11169461|NCT01991743|BG002|Baseline|Group 7.5|"Administration of 7.5mg bupivacaine.~Group 7.5: Administration of 7.5 mg bupivacaine"
11169462|NCT01991743|BG003|Baseline|Group 10|"Administration of 10 mg bupivacaine.~Group 10: Administration of 10mg bupivacaine."
11169463|NCT01991743|BG004|Baseline|Total|Total of all reporting groups
11169464|NCT01991743|FG000|Participant Flow|Drug:Group 2.5|"Administration of 2.5 mg bupivacaine~Group 2.5: Administration of bupivacaine 2.5 mg."
11169465|NCT01991743|FG001|Participant Flow|Group 5|"Administration of 5 mg bupivacaine.~Group 5: Administration of 5 mg bupivacaine"
11169466|NCT01991743|FG002|Participant Flow|Group 7.5|"Administration of 7.5mg bupivacaine.~Group 7.5: Administration of 7.5 mg bupivacaine"
11169467|NCT01991743|FG003|Participant Flow|Group 10|"Administration of 10 mg bupivacaine.~Group 10: Administration of 10mg bupivacaine."
11169468|NCT01991743|OG000|Outcome|Drug:Group 2.5|"Administration of 2.5 mg bupivacaine~Group 2.5: Administration of bupivacaine 2.5 mg."
11169469|NCT01991743|OG001|Outcome|Group 5|"Administration of 5 mg bupivacaine.~Group 5: Administration of 5 mg bupivacaine"
11169470|NCT01991743|OG002|Outcome|Group 7.5|"Administration of 7.5mg bupivacaine.~Group 7.5: Administration of 7.5 mg bupivacaine"
11169471|NCT01991743|OG003|Outcome|Group 10|"Administration of 10 mg bupivacaine.~Group 10: Administration of 10mg bupivacaine."
11169472|NCT01991743|EG000|Reported Event|Group 2.5|Bupivicaine 2.5 mg
11169473|NCT01991743|EG001|Reported Event|Group 5|Bupivicaine 5 mg
11169474|NCT01991743|EG002|Reported Event|Group 7.5|Bupivicaine 7.5 mg
11169475|NCT01991743|EG003|Reported Event|Group 10|Bupivicaine 10 mg
11169476|NCT01991795|BG000|Baseline|Ticagrelor 60 mg|Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
11169477|NCT01991795|BG001|Baseline|Ticagrelor Placebo|Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
11169478|NCT01991795|BG002|Baseline|Total|Total of all reporting groups
11169479|NCT01991795|FG000|Participant Flow|Ticagrelor 60 mg|Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
11169480|NCT01991795|FG001|Participant Flow|Ticagrelor Placebo|Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
11169481|NCT01991795|OG000|Outcome|Ticagrelor 60 mg|Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
11169482|NCT01991795|OG001|Outcome|Ticagrelor Placebo|Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
11169483|NCT01991795|EG000|Reported Event|Ticagrelor 60 mg|Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
11169484|NCT01991795|EG001|Reported Event|Ticagrelor Placebo|Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
11169485|NCT01991808|BG000|Baseline|DCE-MRI|Radiotherapy
11169486|NCT01991808|FG000|Participant Flow|DCE-MRI|Radiotherapy and dynamic contrast enhanced magnetic resonance imaging
11169487|NCT01991808|OG000|Outcome|DCE-MRI|Radiotherapy
11169488|NCT01991808|EG000|Reported Event|DCE-MRI|Radiotherapy
11169489|NCT01991821|BG000|Baseline|APD421|APD421 (amisulpride), at 5 mg given by single intravenous (IV) administration, by slow push over one to two minutes, at induction of anaesthesia.
11169490|NCT01991821|BG001|Baseline|Placebo|Matching placebo, given by single IV administration, by slow push over one minute at the induction of anaesthesia.
11169491|NCT01991821|BG002|Baseline|Total|Total of all reporting groups
11169492|NCT01991821|FG000|Participant Flow|APD421|APD421 (amisulpride), at 5 mg given by single intravenous (IV) administration, by slow push over one to two minutes, at induction of anaesthesia.
11169493|NCT01991821|FG001|Participant Flow|Placebo|Matching placebo, given by single IV administration, by slow push over one minute at the induction of anaesthesia.
11169494|NCT01991821|OG000|Outcome|APD421|APD421 (amisulpride), at 5 mg given by single intravenous (IV) administration, by slow push over one to two minutes, at induction of anaesthesia.
11169495|NCT01991821|OG001|Outcome|Placebo|Matching placebo, given by single IV administration, by slow push over one minute at the induction of anaesthesia.
11169496|NCT01991821|OG000|Outcome|APD421 at 5mg|IV 5mg APD421 single dose
11169497|NCT01991821|OG001|Outcome|Placebo|"IV placebo single dose~Placebo"
11169498|NCT01991821|EG000|Reported Event|APD421 at 5mg|APD421 at 5mg given by single intravenous (IV) administration, by slow push over one to two minutes at induction of anaesthesia.
11169499|NCT01991821|EG001|Reported Event|Placebo|APD421 Placebo given by single IV administration by slow push over one minute at induction of anaesthesia.
11169500|NCT01991860|BG000|Baseline|5mg Dose APD421|A 5mg dose of APD421 given by slow push, single intravenous (IV) administration over a time frame of one minute at induction of anaesthesia
11169501|NCT01991860|BG001|Baseline|Placebo|Single dose placebo given through intravenous (IV) administration
11169502|NCT01991860|BG002|Baseline|Total|Total of all reporting groups
11169503|NCT01991860|FG000|Participant Flow|5mg APD421|A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia
11169504|NCT01991860|FG001|Participant Flow|Placebo|2mL of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia
11169505|NCT01991860|OG000|Outcome|APD421 at 5mg|A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia
11169506|NCT01991860|OG001|Outcome|Placebo|A 2mL dose of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia
11169507|NCT01991860|EG000|Reported Event|APD421 5mg Dose|A 5mg dose of APD421 given by slow push, single intravenous (IV) administration over a time frame of one minute at induction of anaesthesia
11169508|NCT01991860|EG001|Reported Event|Placebo|Placebo given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia
11169509|NCT01991977|BG000|Baseline|Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)|Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
11169510|NCT01991977|FG000|Participant Flow|Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)|Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
11169511|NCT01991977|OG000|Outcome|Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)|Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
11169512|NCT01991977|EG000|Reported Event|Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)|Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
11169513|NCT01991990|BG000|Baseline|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
11169514|NCT01991990|BG001|Baseline|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
11169515|NCT01991990|BG002|Baseline|Total|Total of all reporting groups
11169516|NCT01991990|FG000|Participant Flow|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
11169517|NCT01991990|FG001|Participant Flow|Tocilizumab|Participants received a single dose of intravenous (IV) tocilizumab (TCZ) at a dose of 8 milligrams (mg) per kilogram (kg) body weight infusion over 1 hour on Day 0.
11169518|NCT01991990|OG000|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
11169519|NCT01991990|OG001|Outcome|Tocilizumab (Polymorphonuclear Leukocyte (PMN)]-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with less than or equal to (≤) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
11169520|NCT01991990|OG002|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with greater than (>) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
11169521|NCT01991990|OG001|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
11169522|NCT01991990|OG002|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
11169523|NCT01991990|OG001|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
11169524|NCT01991990|EG000|Reported Event|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
11169525|NCT01991990|EG001|Reported Event|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
11169526|NCT01992016|BG000|Baseline|Arm I (Localized Prostate Cancer)|"Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.~Ranolazine: 1000mg given orally twice daily for 1 day (2 doses)."
11169527|NCT01992016|BG001|Baseline|Arm II (Metastatic Prostate Cancer)|"Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.~Ranolazine: 1000mg given orally twice daily for 1 day (2 doses)."
11169528|NCT01992016|BG002|Baseline|Total|Total of all reporting groups
11169529|NCT01992016|FG000|Participant Flow|Arm I (Localized Prostate Cancer)|"Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.~Ranolazine: 1000mg given orally twice daily for 1 day (2 doses)."
11169530|NCT01992016|FG001|Participant Flow|Arm II (Metastatic Prostate Cancer)|"Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.~Ranolazine: 1000mg given orally twice daily for 1 day (2 doses)."
11355930|NCT03808493|EG002|Reported Event|Pilot BE Study 2: TAK-438 OD 20 mg|TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
11355931|NCT03808493|EG003|Reported Event|Pilot BE Study 2: TAK-438 20 mg|TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
11355932|NCT03815292|BG000|Baseline|MMH-MAP|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.~MMH-MAP: Oral administration"
11355933|NCT03815292|BG001|Baseline|Placebo|"Placebo for 24 weeks, according to the MMH-MAP dosing regimen.~Placebo: Oral administration"
11355934|NCT03815292|BG002|Baseline|Total|Total of all reporting groups
11355935|NCT03815292|FG000|Participant Flow|MMH-MAP|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.~MMH-MAP: Oral administration"
11355936|NCT03815292|FG001|Participant Flow|Placebo|"Placebo for 24 weeks, according to the MMH-MAP dosing regimen.~Placebo: Oral administration"
11355937|NCT03815292|OG000|Outcome|MMH-MAP|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.~MMH-MAP: Oral administration"
11355938|NCT03815292|OG001|Outcome|Placebo|"Placebo for 24 weeks, according to the MMH-MAP dosing regimen.~Placebo: Oral administration"
11355939|NCT03815292|EG000|Reported Event|MMH-MAP|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.~MMH-MAP: Oral administration"
11355940|NCT03815292|EG001|Reported Event|Placebo|"Placebo for 24 weeks, according to the MMH-MAP dosing regimen.~Placebo: Oral administration"
11355941|NCT03812510|BG000|Baseline|A-101 Hydrogen Peroxide Topical Solution 45%|In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. However, Baseline Measures were collected as a single arm for the study.
11355942|NCT03812510|FG000|Participant Flow|A-101|"Topical Solution~A-101: hydrogen peroxide topical solution 45%"
11355943|NCT03812510|OG000|Outcome|A-101 45% (Active)|Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
11355944|NCT03812510|OG001|Outcome|Isopropyl Alcohol and Water (Vehicle)|Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
11355945|NCT03812510|EG000|Reported Event|A-101 A-101: Hydrogen Peroxide Topical Solution 45%|In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. However, Baseline Measures were collected as a single arm for the study.
11355946|NCT03802994|BG000|Baseline|1.Aging RT|"Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 was used for flow cytometric analysis."
11355947|NCT03802994|BG001|Baseline|2.Young RT|"Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0, 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis."
11355948|NCT03802994|BG002|Baseline|3.Healthy Elderly|"Healthy persons between the ages 65-75 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23). Samples obtained from days 0, 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 was used for flow cytometric analysis."
11355949|NCT03802994|BG003|Baseline|4.Elderly DMII or HTN and Normal Renal Function|"Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30. Samples from day 7 were used for flow cytometric analysis."
11355950|NCT03802994|BG004|Baseline|5.Healthy Young|"Healthy persons between the ages 35-45 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23).~23 valent pneumococcal polysaccharide vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 23 different pneumococcal serotypes. All young healthy participants recruited were already immunized with pneumovax at least one year prior to enrollment~13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was adminstered at day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 was given as standard of care.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0, 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis."
11169531|NCT01992016|OG000|Outcome|Arm I (Localized Prostate Cancer)|"Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.~Ranolazine: 1000mg given orally twice daily for 1 day (2 doses)."
11169532|NCT01992016|OG001|Outcome|Arm II (Metastatic Prostate Cancer)|"Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.~Ranolazine: 1000mg given orally twice daily for 1 day (2 doses)."
11169533|NCT01992016|EG000|Reported Event|Arm I (Localized Prostate Cancer)|"Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.~Ranolazine: 1000mg given orally twice daily for 1 day (2 doses)."
11169534|NCT01992016|EG001|Reported Event|Arm II (Metastatic Prostate Cancer)|"Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.~Ranolazine: 1000mg given orally twice daily for 1 day (2 doses)."
11169535|NCT01992094|BG000|Baseline|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
11169536|NCT01992094|BG001|Baseline|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
11169537|NCT01992094|BG002|Baseline|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169538|NCT01992094|BG003|Baseline|Total|Total of all reporting groups
11169539|NCT01992094|FG000|Participant Flow|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
11169540|NCT01992094|FG001|Participant Flow|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
11169541|NCT01992094|FG002|Participant Flow|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169542|NCT01992094|OG000|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
11169543|NCT01992094|OG001|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169544|NCT01992094|OG002|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169545|NCT01992094|OG000|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
11169546|NCT01992094|OG001|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
11169547|NCT01992094|OG002|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013- 2014 season
11169548|NCT01992094|OG003|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
11169549|NCT01992094|OG004|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169550|NCT01992094|OG005|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169551|NCT01992094|OG002|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
11169552|NCT01992094|OG003|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
11169553|NCT01992094|OG000|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
11169554|NCT01992094|OG001|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
11169555|NCT01992094|OG002|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
11169556|NCT01992094|OG003|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
11169557|NCT01992094|OG004|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169558|NCT01992094|OG005|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169559|NCT01992094|OG001|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169560|NCT01992094|EG000|Reported Event|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
11169561|NCT01992094|EG001|Reported Event|TIV1c (≥ 18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169562|NCT01992094|EG002|Reported Event|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11355951|NCT03802994|BG005|Baseline|Total|Total of all reporting groups
11169563|NCT01992094|EG003|Reported Event|Total|Total Number of Subjects
11169564|NCT01992107|BG000|Baseline|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169565|NCT01992107|BG001|Baseline|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169566|NCT01992107|BG002|Baseline|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169567|NCT01992107|BG003|Baseline|Total|Total of all reporting groups
11355952|NCT03802994|FG000|Participant Flow|1.Aging RT|"Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) will be collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) for groups 1-4 and at days 366, 373 and 396 for group 5. In addition, day 5, and 10 blood samples will be obtained from a limited (n=10) number of elderly RT participants to determine the optimal time point for circulation of PPS-specific B cells. Yearly blood samples will be obtained thereafter for serum antibody and OPA analyses to test longevity of antibody and OPA responses. Samples obtained from days 0, 30 and yearly samples will be used for antibody titers and opsonophagocytic assays. Samples from day 0 (day of vaccination with PCV13) and day 7 will be used for flow cytometric analysis."
11355953|NCT03802994|FG001|Participant Flow|2.Young RT|"Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) will be collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) for groups 1-4 and at days 366, 373 and 396 for group 5. In addition, day 5, and 10 blood samples will be obtained from a limited (n=10) number of elderly RT participants to determine the optimal time point for circulation of PPS-specific B cells. Yearly blood samples will be obtained thereafter for serum antibody and OPA analyses to test longevity of antibody and OPA responses. Samples obtained from days 0, 30 and yearly samples will be used for antibody titers and opsonophagocytic assays. Samples from day 0 (day of vaccination with PCV13) and day 7 will be used for flow cytometric analysis."
11355954|NCT03802994|FG002|Participant Flow|3.Healthy Elderly|"Healthy persons between the ages 65-75 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) will be collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) for groups 1-4 and at days 366, 373 and 396 for group 5. In addition, day 5, and 10 blood samples will be obtained from a limited (n=10) number of elderly RT participants to determine the optimal time point for circulation of PPS-specific B cells. Yearly blood samples will be obtained thereafter for serum antibody and OPA analyses to test longevity of antibody and OPA responses. Samples obtained from days 0, 30 and yearly samples will be used for antibody titers and opsonophagocytic assays. Samples from day 0 (day of vaccination with PCV13) and day 7 will be used for flow cytometric analysis."
11355955|NCT03802994|FG003|Participant Flow|4.Elderly DMII or HTN and Normal Renal Function|"Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) will be collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) for groups 1-4 and at days 366, 373 and 396 for group 5. In addition, day 5, and 10 blood samples will be obtained from a limited (n=10) number of elderly RT participants to determine the optimal time point for circulation of PPS-specific B cells. Yearly blood samples will be obtained thereafter for serum antibody and OPA analyses to test longevity of antibody and OPA responses. Samples obtained from days 0, 30 and yearly samples will be used for antibody titers and opsonophagocytic assays. Samples from day 0 (day of vaccination with PCV13) and day 7 will be used for flow cytometric analysis."
11355956|NCT03802994|FG004|Participant Flow|5.Healthy Young|"Healthy persons between the ages 35-45 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) or are willing to receive PPV23 and 1 year later Prevnar 13.~23 valent pneumococcal polysaccharide vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 23 different pneumococcal serotypes. Only group 5 will potentially receive this as an intervention.~13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197. Only group 5 will receive this as an intervention. In all other groups Prevnar 13 will be given as standard of care.~Peripheral blood sample: Peripheral blood samples (30-60 mL) will be collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) for groups 1-4 and at days 366, 373 and 396 for group 5. In addition, day 5, and 10 blood samples will be obtained from a limited (n=10) number of elderly RT participants to determine the optimal time point for circulation of PPS-specific B cells. Yearly blood samples will be obtained thereafter for serum antibody and OPA analyses to test longevity of antibody and OPA responses. Samples obtained from days 0, 30 and yearly samples will be used for antibody titers and opsonophagocytic assays. Samples from day 0 (day of vaccination with PCV13) and day 7 will be used for flow cytometric analysis."
11355957|NCT03802994|OG000|Outcome|1.Aging RT|"Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis."
11355958|NCT03802994|OG001|Outcome|2.Young RT|"Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis."
11355959|NCT03802994|OG002|Outcome|3.Healthy Elderly|"Healthy persons between the ages 65-75 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis."
11089846|NCT01525602|EG005|Reported Event|Part 3: PLX3397 600 mg BID|All participants with advanced solid tumors who received PLX3397 600 mg BID as lead-in treatment.
11089847|NCT01525602|EG006|Reported Event|Part 3: Paclitaxel 80 mg/m^2|All participants with advanced solid tumors who received paclitaxel 80 mg/m^2 intravenous weekly as lead-in treatment.
11169568|NCT01992107|FG000|Participant Flow|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169569|NCT01992107|FG001|Participant Flow|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169570|NCT01992107|FG002|Participant Flow|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169571|NCT01992107|OG000|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169572|NCT01992107|OG001|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169573|NCT01992107|OG002|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169574|NCT01992107|OG001|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169575|NCT01992107|OG000|Outcome|QIVc _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169576|NCT01992107|OG001|Outcome|TIV1c_First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169577|NCT01992107|OG002|Outcome|TIV2c _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169578|NCT01992107|OG003|Outcome|QIVc _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169579|NCT01992107|OG004|Outcome|TIV1c_Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169580|NCT01992107|OG005|Outcome|TIV2c _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169581|NCT01992107|OG006|Outcome|QIVc _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169582|NCT01992107|OG007|Outcome|TIV1c_First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2,B1) recommended for 2013-2014 season
11169583|NCT01992107|OG008|Outcome|TIV2c _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169584|NCT01992107|OG009|Outcome|QIVc _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169585|NCT01992107|OG010|Outcome|TIV1c_Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169586|NCT01992107|OG011|Outcome|TIV2c _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169587|NCT01992107|OG012|Outcome|QIVc (≥9 to <18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169588|NCT01992107|OG013|Outcome|TIV1c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169589|NCT01992107|OG014|Outcome|TIV2c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169590|NCT01992107|EG000|Reported Event|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
11169591|NCT01992107|EG001|Reported Event|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
11169592|NCT01992107|EG002|Reported Event|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
11169593|NCT01992107|EG003|Reported Event|Total|Total number of Subjects
11169594|NCT01992159|BG000|Baseline|Placebo|Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
11169595|NCT01992159|BG001|Baseline|Romosozumab 70 mg|Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169596|NCT01992159|BG002|Baseline|Romosozumab 140 mg|Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169597|NCT01992159|BG003|Baseline|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169598|NCT01992159|BG004|Baseline|Total|Total of all reporting groups
11169599|NCT01992159|FG000|Participant Flow|Placebo|Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
11169600|NCT01992159|FG001|Participant Flow|Romosozumab 70 mg|Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169601|NCT01992159|FG002|Participant Flow|Romosozumab 140 mg|Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169602|NCT01992159|FG003|Participant Flow|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169603|NCT01992159|OG000|Outcome|Placebo|Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
11169604|NCT01992159|OG001|Outcome|Romosozumab 70 mg|Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169605|NCT01992159|OG002|Outcome|Romosozumab 140 mg|Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169606|NCT01992159|OG003|Outcome|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169607|NCT01992159|EG000|Reported Event|Placebo|Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
11169608|NCT01992159|EG001|Reported Event|Romosozumab 70 mg|Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169609|NCT01992159|EG002|Reported Event|Romosozumab 140 mg|Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169610|NCT01992159|EG003|Reported Event|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11169611|NCT01992172|BG000|Baseline|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
11169612|NCT01992172|BG001|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11169613|NCT01992172|BG002|Baseline|Total|Total of all reporting groups
11169614|NCT01992172|FG000|Participant Flow|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
11169615|NCT01992172|FG001|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11169616|NCT01992172|OG000|Outcome|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
11169617|NCT01992172|OG001|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11169618|NCT01992172|EG000|Reported Event|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
11169619|NCT01992172|EG001|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11169620|NCT01992185|BG000|Baseline|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
11169621|NCT01992185|BG001|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11169622|NCT01992185|BG002|Baseline|Total|Total of all reporting groups
11169623|NCT01992185|FG000|Participant Flow|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
11169624|NCT01992185|FG001|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11169625|NCT01992185|OG000|Outcome|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
11169626|NCT01992185|OG001|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11169627|NCT01992185|EG000|Reported Event|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
11169628|NCT01992185|EG001|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
11169629|NCT01992354|BG000|Baseline|Single Arm|"Evaluation of PET MR device for image assessment and device performance~PET MR Device: GE PET/MRI system"
11169630|NCT01992354|FG000|Participant Flow|PET/MR System|"Evaluation of Positron Emission Tomography/Magnetic Resonance (PET/MR) device for image assessment and device performance~PET MR Device: General Electric (GE) PET/MRI system"
11169631|NCT01992354|OG000|Outcome|PET/MR System|"Evaluation of PET MR device for image assessment and device performance~PET MR Device: GE PET/MRI system"
11169632|NCT01992354|OG000|Outcome|PET/MR System|"Evaluation of Positron Emission Tomography/Magnetic Resonance (PET/MR) device for image assessment and device performance~PET MR Device: General Electric (GE) PET/MRI system"
11169633|NCT01992354|EG000|Reported Event|PET/MR System|"Evaluation of PET MR device for image assessment and device performance~PET MR Device: GE PET/MRI system"
11169634|NCT01992380|BG000|Baseline|Healthy Volunteer Subjects|"Healthy males or females 50 years or older with no evidence of cognitive impairment~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169635|NCT01992380|BG001|Baseline|MCI Subjects|"Subjects 50 years or older with mild cognitive impairment (MCI)~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169636|NCT01992380|BG002|Baseline|Probable AD Subjects|"Subjects 50 years or older with probable Alzheimer's Disease (AD)~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169637|NCT01992380|BG003|Baseline|Total|Total of all reporting groups
11169638|NCT01992380|FG000|Participant Flow|Healthy Volunteer Subjects|"Healthy males or females 50 years or older with no evidence of cognitive impairment~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169639|NCT01992380|FG001|Participant Flow|MCI Subjects|"Subjects 50 years or older with mild cognitive impairment (MCI)~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169640|NCT01992380|FG002|Participant Flow|Probable AD Subjects|"Subjects 50 years or older with probable Alzheimer's Disease (AD)~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169641|NCT01992380|OG000|Outcome|All Subjects|"All study subjects~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169642|NCT01992380|EG000|Reported Event|Healthy Volunteer Subjects|"Healthy males or females 50 years or older with no evidence of cognitive impairment~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169643|NCT01992380|EG001|Reported Event|MCI Subjects|"Subjects 50 years or older with mild cognitive impairment (MCI)~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169644|NCT01992380|EG002|Reported Event|Probable AD Subjects|"Subjects 50 years or older with probable Alzheimer's Disease (AD)~Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart~Brain PET scan: positron emission tomography (PET) scan of the brain"
11169645|NCT01992523|BG000|Baseline|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
11169646|NCT01992523|BG001|Baseline|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
11169647|NCT01992523|BG002|Baseline|Total|Total of all reporting groups
11169648|NCT01992523|FG000|Participant Flow|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
11169649|NCT01992523|FG001|Participant Flow|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
11169650|NCT01992523|OG000|Outcome|Ticagrelor Mashed Pills|
11169651|NCT01992523|OG001|Outcome|Ticagrelor Integral Pills|
11169652|NCT01992523|OG000|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
11169653|NCT01992523|OG001|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
11169654|NCT01992523|EG000|Reported Event|Ticagrelor Mashed Group|patients taking orally 180 mg ticagrelor mashed tablets
11169655|NCT01992523|EG001|Reported Event|Ticagrelor Integral Group|patients taking orally 180 mg ticagrelor integral tablets
11169656|NCT01992536|BG000|Baseline|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
11169657|NCT01992536|BG001|Baseline|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
11169658|NCT01992536|BG002|Baseline|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
11169659|NCT01992536|BG003|Baseline|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
11169660|NCT01992536|BG004|Baseline|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
11169661|NCT01992536|BG005|Baseline|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169662|NCT01992536|BG006|Baseline|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
11169663|NCT01992536|BG007|Baseline|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
11169664|NCT01992536|BG008|Baseline|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169665|NCT01992536|BG009|Baseline|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
11169666|NCT01992536|BG010|Baseline|Total|Total of all reporting groups
11169667|NCT01992536|FG000|Participant Flow|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
11169668|NCT01992536|FG001|Participant Flow|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
11169669|NCT01992536|FG002|Participant Flow|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
11232942|NCT02422940|EG000|Reported Event|Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.~Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.~dalfampridine-ER 7.5 mg"
11232943|NCT02422940|EG001|Reported Event|Dalfampridine-ER 10 mg|"Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.~Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.~dalfampridine-ER 10 mg"
11233979|NCT02431650|OG000|Outcome|Primaquine 15mg|"Administration of Primaquine 15mg (control).~Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. When PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants of this arm will receive 15mg of Primaquine treatment as the control."
11233980|NCT02431650|OG001|Outcome|OZ439 500mg|"Administration of OZ439 500mg.~Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. When PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants will receive 500mg of OZ439."
11233981|NCT02431650|EG000|Reported Event|Primaquine 15mg|"Administration of Primaquine 15mg (control).~Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. When PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants of this arm will receive 15mg of Primaquine treatment as the control."
11233982|NCT02431650|EG001|Reported Event|OZ439 500mg|"Administration of OZ439 500mg.~Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. When PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants will receive 500mg of OZ439."
11233983|NCT02431676|BG000|Baseline|Self-Directed|"In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.~Self-control weight loss"
11233984|NCT02431676|BG001|Baseline|Coach Directed Behavioral Weight Loss|"The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight~Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals"
11233985|NCT02431676|BG002|Baseline|Metformin|"This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals~Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months."
11233986|NCT02431676|BG003|Baseline|Total|Total of all reporting groups
11233987|NCT02431676|FG000|Participant Flow|Self-Directed|"In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.~Self-control weight loss"
11233988|NCT02431676|FG001|Participant Flow|Coach Directed Behavioral Weight Loss|"The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight~Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals"
11233989|NCT02431676|FG002|Participant Flow|Metformin|"This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals~Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months."
11357425|NCT03758365|EG000|Reported Event|MC2-01 Cream|"Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream~MC2-01 Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11233990|NCT02431676|OG000|Outcome|Self-Directed|"In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.~Self-control weight loss"
11233991|NCT02431676|OG001|Outcome|Coach Directed Behavioral Weight Loss|"The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight~Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals"
11233992|NCT02431676|OG002|Outcome|Metformin|"This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals~Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months."
11355960|NCT03802994|OG003|Outcome|4.Elderly DMII or HTN and Normal Renal Function|"Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis."
11355961|NCT03802994|OG004|Outcome|5.Healthy Young|"Healthy persons between the ages 35-45 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was used for immunization at day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 will be given as standard of care.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis."
11355962|NCT03802994|OG004|Outcome|5.Healthy Young|"Healthy persons between the ages 35-45 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was administered on day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 was given as standard of care.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis."
11355963|NCT03802994|OG000|Outcome|1.Aging RT|"Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause of renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 7 were used for flow cytometric analysis."
11355964|NCT03802994|OG001|Outcome|2.Young RT|"Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause of renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 7 were used for flow cytometric analysis."
11169670|NCT01992536|FG003|Participant Flow|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
11169671|NCT01992536|FG004|Participant Flow|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
11169672|NCT01992536|FG005|Participant Flow|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169673|NCT01992536|FG006|Participant Flow|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
11169674|NCT01992536|FG007|Participant Flow|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
11169675|NCT01992536|FG008|Participant Flow|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169676|NCT01992536|FG009|Participant Flow|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
11169677|NCT01992536|OG000|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
11169678|NCT01992536|OG001|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
11355965|NCT03802994|OG002|Outcome|3.Healthy Elderly|"Healthy persons between the ages 65-75 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23).~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 7 were used for flow cytometric analysis."
11355966|NCT03802994|OG003|Outcome|4.Elderly DMII or HTN and Normal Renal Function|"Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 7 were used for flow cytometric analysis."
11169679|NCT01992536|OG000|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
11357426|NCT03758365|EG001|Reported Event|Clobetasol Propionate 0.05% Lotion|"Single application of Clobetasol propionate 0.05%,~Clobetasol Propionate 0.05% Lotion: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11169680|NCT01992536|OG001|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
11169681|NCT01992536|OG002|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
11169682|NCT01992536|OG003|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
11169683|NCT01992536|OG001|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
11169684|NCT01992536|OG002|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
11169685|NCT01992536|OG003|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
11355967|NCT03802994|OG004|Outcome|5.Healthy Young|"Healthy persons between the ages 35-45 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was administered on day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 was given as standard of care.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 7 were used for flow cytometric analysis."
11355968|NCT03802994|OG000|Outcome|1.Aging RT|"Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause of renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 0 were used for measuring inflammatory markers."
11355969|NCT03802994|OG001|Outcome|2.Young RT|"Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause of renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 0 were used for measuring inflammatory markers."
11355970|NCT03802994|OG002|Outcome|3.Healthy Elderly|"Healthy persons between the ages 65-75 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 0 were used for measuring inflammatory markers."
11355971|NCT03802994|OG003|Outcome|4.Elderly DMII or HTN and Normal Renal Function|"Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 0 were used for measuring inflammatory markers."
11355972|NCT03802994|OG004|Outcome|5.Healthy Young|"Healthy persons between the ages 35-45 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was administered on day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 was given as standard of care.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples from day 0 were used for measuring inflammatory markers."
11355973|NCT03802994|EG000|Reported Event|1.Aging RT|"Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) ."
11355974|NCT03802994|EG001|Reported Event|2.Young RT|"Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN.~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) ."
11169686|NCT01992536|OG004|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
11355975|NCT03802994|EG002|Reported Event|3.Healthy Elderly|"Healthy persons between the ages 65-75 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) ."
11355976|NCT03802994|EG003|Reported Event|4.Elderly DMII or HTN and Normal Renal Function|"Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23)~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) ."
11355977|NCT03802994|EG004|Reported Event|5.Healthy Young|"Healthy persons between the ages 35-45 who previously (>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine~Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) ."
11355978|NCT03810183|BG000|Baseline|QAW039 450 mg|QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
11355979|NCT03810183|BG001|Baseline|Placebo|Placebo once daily for 6 weeks administered orally as a tablet.
11355980|NCT03810183|BG002|Baseline|Total|Total of all reporting groups
11355981|NCT03810183|FG000|Participant Flow|QAW039 450 mg|QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
11355982|NCT03810183|FG001|Participant Flow|Placebo|Placebo once daily for 6 weeks administered orally as a tablet.
11355983|NCT03810183|OG000|Outcome|QAW039 450 mg|QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
11355984|NCT03810183|OG001|Outcome|Placebo|Placebo once daily for 6 weeks administered orally as a tablet.
11169687|NCT01992536|OG005|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
11355985|NCT03810183|EG000|Reported Event|QAW039 450mg|QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
11355986|NCT03810183|EG001|Reported Event|Placebo|Placebo once daily for 6 weeks administered orally as a tablet.
11355987|NCT03810183|EG002|Reported Event|Total|Total
11355988|NCT03809910|BG000|Baseline|All Treatment Combined|All randomized participants received treatment in either sequence A-B-C or sequence B-A-C. Participants in the product sequence A-B-C applied Prototype PTB (A) in Period 1 followed by Reference MTB (B) in Period 2 and Reference PTB (C) in Period 3, whereas, in product sequence B-A-C participants applied Reference MTB (B) in Period 1 followed by Prototype PTB (A) in Period 2 and Reference PTB (C) in Period 3.
11169688|NCT01992536|OG006|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
11169689|NCT01992536|OG007|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
11169690|NCT01992536|OG008|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
11169691|NCT01992536|OG005|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
11169692|NCT01992536|OG003|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
11169693|NCT01992536|OG004|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
11169694|NCT01992536|OG005|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169695|NCT01992536|OG007|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169696|NCT01992536|OG002|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
11169697|NCT01992536|OG003|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
11169698|NCT01992536|OG004|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
11169699|NCT01992536|OG005|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
11169700|NCT01992536|OG006|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
11169701|NCT01992536|OG007|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
11169702|NCT01992536|OG008|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169703|NCT01992536|OG009|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
11169704|NCT01992536|OG010|Outcome|Total|
11169705|NCT01992536|OG008|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
11169706|NCT01992536|EG000|Reported Event|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
11169707|NCT01992536|EG001|Reported Event|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
11169708|NCT01992536|EG002|Reported Event|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
11169709|NCT01992536|EG003|Reported Event|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
11169710|NCT01992536|EG004|Reported Event|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
11169711|NCT01992536|EG005|Reported Event|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169712|NCT01992536|EG006|Reported Event|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
11169713|NCT01992536|EG007|Reported Event|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
11169714|NCT01992536|EG008|Reported Event|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
11169715|NCT01992536|EG009|Reported Event|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
11169716|NCT01992536|EG010|Reported Event|Total|Total
11169717|NCT01992549|BG000|Baseline|Human-cl rhFVIII|The safety (SAF) population consist of all patients who received at least one infusion of Human-cl rhFVIII (n=48).
11174170|NCT02019979|OG000|Outcome|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
11174171|NCT02019979|EG000|Reported Event|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
11174172|NCT02020018|BG000|Baseline|Prospective Group|Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
11174173|NCT02020018|BG001|Baseline|Retrospective Arm|Conventional sterile dry wound dressing applied immediately postoperatively.
11174174|NCT02020018|BG002|Baseline|Total|Total of all reporting groups
11169718|NCT01992549|FG000|Participant Flow|Human-cl rhFVIII|Of the total number of patients that started in the study, all those in the safety (SAF) population received at least 1 infusion of Human-cl rhFVIII. Patients who had data collected post-treatment were included in the intent-to-treat (ITT) population. Prophylactic treatment dose given to all patients in the PROPH population (all patients who received at least 1 administration of Human-cl rhFVIII with prophylaxis documented as the reason for treatment): >20 IU FVIII/kg body weight (BW). On-demand treatment of bleeding episodes (BEs) dose given to the BLEED population (all patients with bleeding episodes treated with Human-cl rhFVIII): 20-30 IU FVIII/kg BW (minor haemorrhage), 30-40 IU FVIII/kg BW (moderate to major haemorrhage) or 50-80 IU FVIII/kg BW (major to life-threatening haemorrhage). Surgical prophylaxis dose was given to the SURG population (all patients with surgeries treated with Human-cl rhFVIII): 25-30 IU FVIII/kg BW (minor surgeries); >50 IU FVIII/kg BW (major surgeries).
11169719|NCT01992549|OG000|Outcome|Human-cl rhFVIII|The safety (SAF) population consist of all patients who received at least one infusion of Human-cl rhFVIII
11169720|NCT01992549|OG000|Outcome|ITT/PROPH Population|All patients who had data collected post-treatment with Human-cl rhFVIII and at least one prophylactic treatment with Human-cl rhFVIII (n=47).
11169721|NCT01992549|OG000|Outcome|BLEED Population|All patients that experienced at least one bleeding episode treated with Human-cl rhFVIII (n=29)
11169722|NCT01992549|OG000|Outcome|Minor Surgeries|All patients that had minor surgeries performed under Human-cl rhFVIII treatment (n=1)
11169723|NCT01992549|OG001|Outcome|Major Surgeries|All patients that had major surgeries performed under Human-cl rhFVIII treatment (n=2)
11169724|NCT01992549|OG002|Outcome|SURG Population|All patients that had surgeries performed under Human-cl rhFVIII treatment (n=3)
11169725|NCT01992549|OG000|Outcome|SAF Population|The safety (SAF) population consist of all patients who received at least one infusion of Human-cl rhFVIII (n=48).
11169726|NCT01992549|EG000|Reported Event|SAF Population|The safety (SAF) population consist of all patients who received at least one infusion of Human-cl rhFVIII (n=48).
11169727|NCT01992757|BG000|Baseline|Cardiac Surgery With Cardiopulmary Bypass|patients over the age of 18 years undergoing cardiac surgery requiring CPB. patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.
11169728|NCT01992757|FG000|Participant Flow|Cardiac Surgery With Cardiopulmary Bypass|Patients over the age of 18 years undergoing cardiac surgery requiring CPB. Patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.
11169729|NCT01992757|OG000|Outcome|FLEV Difference During Rewarming & Post-cardiopulmonary Bypass|All enrolled patients were in a single arm with multiple timepoints. FLEV values were obtained at baseline, rewarming, and post-CPB. The primary outcome was to compare the rewarming and post-CPB values to determine if a significant difference exists.
11169730|NCT01992757|OG000|Outcome|Clauss vs FLEV at Rewarming and Post-CPB|All enrolled patients were in a single arm with multiple timepoints. Clauss assay and FLEV values were obtained at baseline, rewarming, and post-CPB. The secondary outcome was to compare the rewarming and post-CPB values of Clauss value to FLEV to determine if a significant difference exists.
11357427|NCT03758365|EG002|Reported Event|Betamethasone Dipropionate 0.05% Cream|"Single application of Betamethasone dipropionate 0.05%,~Betamethasone Dipropionate 0.05% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11169731|NCT01992757|EG000|Reported Event|Cardiac Surgery With Cardiopulmary Bypass|patients over the age of 18 years undergoing cardiac surgery requiring CPB. patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.
11169732|NCT01992874|BG000|Baseline|Entire Study Population|It included all the subjects randomized to receive either Pimasertib 60 mg capsule and Pimasertib 60 mg tablet first in Part A and Pimasertib 60 mg capsule in Part B of the study.
11169733|NCT01992874|FG000|Participant Flow|Part A: Pimasertib Capsule Then Pimasertib Tablet|A single dose of 2 Pimasertib 30 mg capsule administered orally on Day 1 in first intervention period followed by a single dose of 3 Pimasertib 20 mg tablet single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
11169734|NCT01992874|FG001|Participant Flow|Part A: Pimasertib Tablet Then Pimasertib Capsule|A single dose of 3 Pimasertib 20 mg tablet administered orally on Day 1 in first intervention period followed by a single dose of 2 Pimasertib 30 mg capsule single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
11169735|NCT01992874|FG002|Participant Flow|Part B:Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
11169736|NCT01992874|OG000|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
11169737|NCT01992874|OG001|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
11169738|NCT01992874|OG000|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study
11169739|NCT01992874|OG002|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
11169740|NCT01992874|OG000|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
11169741|NCT01992874|EG000|Reported Event|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
11357428|NCT03758365|EG003|Reported Event|Triamcinolone Acetonide 0.1% Cream|"Single application of Triamcinolone acetonide 0.1%,~Triamcinolone Acetonide 0.1% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11355989|NCT03809910|FG000|Participant Flow|Sequence A-B-C|Participants randomized to this group brushed their teeth as follows in supervision of study staff during site visit: Prototype PTB (A) in Period 1 (for 2 timed minutes [min] in 'Gumline' mode and 1 timed min in 'Interdental' mode) followed by Reference MTB (B) in Period 2 (for 1 timed min) and Reference PTB (C) in Period 3 (for 2 timed min). Clinical assessments were performed after 'Gumline' mode and 'Interdental' mode in same treatment period. Each treatment period was followed by a minimum of 3-days washout period and prior to each site visit, participants abstained from all oral hygiene for at least 12 hours. Participants received a fluoride toothpaste and manual toothbrush to use at home during washout period, recorded each brushing occasion (at home) and time of their last brushing prior to their next scheduled appointment on their diary. Overall study duration from first subject first visit (FSFV) to last subject last visit (LSLV) was 32 days.
11355990|NCT03809910|FG001|Participant Flow|Sequence B-A-C|Participants randomized to this group brushed their teeth as follows in supervision of study staff during site visit: Reference MTB (B) in Period 1 (for 1 timed minute) followed by Prototype PTB (A) in Period 2 (for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode) and Reference PTB in Period 3 (C) (for 2 timed minutes). Clinical assessments were performed after 'Gumline' mode and after 'Interdental' mode in same treatment period. Each treatment period was followed by a minimum of 3-days washout period and prior to each site visit, participants abstained from all oral hygiene for at least 12 hours. Participants received a fluoride toothpaste and manual toothbrush to use at home during the washout period and recorded each brushing occasion (at home) and time of their last brushing prior to their next scheduled appointment on their diary. Overall study duration from FSFV to LSLV was 32 days.
11355991|NCT03809910|OG000|Outcome|"Prototype PTB Gumline"|Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode.
11355992|NCT03809910|OG001|Outcome|Reference MTB|Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.
11355993|NCT03809910|OG000|Outcome|"Prototype PTB Combined"|Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.
11355994|NCT03809910|OG001|Outcome|"Prototype PTB Combined"|Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode.
11355995|NCT03809910|OG002|Outcome|Reference PTB|Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
11355996|NCT03809910|EG000|Reported Event|Prototype PTB (A)|Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode in same treatment period.
11355997|NCT03809910|EG001|Reported Event|Reference MTB (B)|Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.
11355998|NCT03809910|EG002|Reported Event|Reference PTB (C)|Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
11355999|NCT03806790|BG000|Baseline|LEO 90100 Foam|"calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g~LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion."
11356000|NCT03806790|BG001|Baseline|Dovobet® Ointment|"calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g~Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion."
11356001|NCT03806790|BG002|Baseline|Total|Total of all reporting groups
11356002|NCT03806790|FG000|Participant Flow|LEO 90100 Foam|"calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g~LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion."
11356003|NCT03806790|FG001|Participant Flow|Dovobet® Ointment|"calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g~Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion."
11356004|NCT03806790|OG000|Outcome|LEO 90100 Foam|"calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g~LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion."
11356005|NCT03806790|OG001|Outcome|Dovobet® Ointment|"calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g~Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion."
11356006|NCT03806790|EG000|Reported Event|LEO 90100 Foam|"calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g~LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion."
11356007|NCT03806790|EG001|Reported Event|Dovobet® Ointment|"calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g~Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion."
11089848|NCT01525602|EG007|Reported Event|Part 3: PLX3397 600 mg BID + Paclitaxel 80 mg/m^2|All participants who received PLX3397 600 mg BID + paclitaxel 80 mg/m^2 intravenous weekly as lead-in treatment.
11089849|NCT01525615|BG000|Baseline|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
11356008|NCT03807245|BG000|Baseline|GBS-NN/NN2 With Alhydrogel® 25|GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
11356009|NCT03807245|BG001|Baseline|GBS-NN/NN2 With Alhydrogel® 50|GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
11169742|NCT01992874|EG001|Reported Event|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
11169743|NCT01992874|EG002|Reported Event|Part B: Pimasertib Capsule (BID)|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
11169744|NCT01993017|BG000|Baseline|AHA Depression Screen, Notify & Treat|"Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to stepped care. Stepped care includes, a) participant preference for either a type of brief, cognitive behavioral therapy (CBT) called problem solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with stepping up of care if sufficient progress is not being realized."
11169745|NCT01993017|BG001|Baseline|Depression Screen & Notify|"Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.~Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.~Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"
11356010|NCT03807245|BG002|Baseline|Placebo With Alhydrogel®|Placebo (buffer with Alhydrogel®) vaccine administered by intramuscular injection 2 times with 4 weeks apart
11356011|NCT03807245|BG003|Baseline|Total|Total of all reporting groups
11356012|NCT03807245|FG000|Participant Flow|GBS-NN/NN2 With Alhydrogel® 25|GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
11356013|NCT03807245|FG001|Participant Flow|GBS-NN/NN2 With Alhydrogel® 50|GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
11169746|NCT01993017|BG002|Baseline|No Depression Screen|"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.~No intervention"
11169747|NCT01993017|BG003|Baseline|Total|Total of all reporting groups
11169748|NCT01993017|FG000|Participant Flow|AHA Depression Screen, Notify & Treat|"Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to stepped care. Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with stepping up of care if sufficient progress is not being realized."
11169749|NCT01993017|FG001|Participant Flow|Depression Screen & Notify|"Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.~Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.~Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"
11169750|NCT01993017|FG002|Participant Flow|No Depression Screen|"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.~No intervention"
11174175|NCT02020018|FG000|Participant Flow|Prospective Group|Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
11174176|NCT02020018|FG001|Participant Flow|Retrospective Arm|Conventional sterile dry wound dressing applied immediately postoperatively.
11356014|NCT03807245|FG002|Participant Flow|Placebo With Alhydrogel®|Placebo (buffer with Alhydrogel®) vaccine administered by intramuscular injection 2 times with 4 weeks apart
11356015|NCT03807245|OG000|Outcome|GBS-NN/NN2 With Alhydrogel® 25|GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
11356016|NCT03807245|OG001|Outcome|GBS-NN/NN2 With Alhydrogel® 50|GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
11356017|NCT03807245|OG002|Outcome|Placebo With Alhydrogel®|Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart
11356018|NCT03807245|EG000|Reported Event|GBS-NN/NN2 With Alhydrogel® 25|GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
11356019|NCT03807245|EG001|Reported Event|GBS-NN/NN2 With Alhydrogel® 50|GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart
11356020|NCT03807245|EG002|Reported Event|Placebo With Alhydrogel®|Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart
11356021|NCT03805971|BG000|Baseline|Patient Aged More Than 18 Years Admitted for Thoracoscopy|"Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies~Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool."
11357429|NCT03758365|EG004|Reported Event|Hydrocortisone Butyrate 0.1% Cream|"Single application of Hydrocortisone Butyrate 0.1% Cream~Hydrocortisone Butyrate 0.1% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11169751|NCT01993017|OG000|Outcome|AHA Depression Screen, Notify & Treat|"Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to stepped care. Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with stepping up of care if sufficient progress is not being realized."
11169752|NCT01993017|OG001|Outcome|Depression Screen & Notify|"Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.~Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.~Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"
11169753|NCT01993017|OG002|Outcome|No Depression Screen|"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.~No intervention"
11169754|NCT01993017|OG000|Outcome|AHA Depression Screen, Notify & Treat|"Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to stepped care. Stepped care includes, a) participant preference for either a type of brief, cognitive behavioral therapy (CBT) called problem solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with stepping up of care if sufficient progress is not being realized."
11169755|NCT01993017|EG000|Reported Event|AHA Depression Screen, Notify & Treat|"Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to stepped care. Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with stepping up of care if sufficient progress is not being realized."
11169756|NCT01993017|EG001|Reported Event|Depression Screen & Notify|"Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.~Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.~Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"
11169757|NCT01993017|EG002|Reported Event|No Depression Screen|"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.~No intervention"
11169758|NCT01993030|BG000|Baseline|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
11169759|NCT01993030|BG001|Baseline|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
11169760|NCT01993030|BG002|Baseline|Total|Total of all reporting groups
11169761|NCT01993030|FG000|Participant Flow|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
11169762|NCT01993030|FG001|Participant Flow|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
11169763|NCT01993030|OG000|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
11169764|NCT01993030|OG001|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
11169765|NCT01993030|EG000|Reported Event|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
11169766|NCT01993030|EG001|Reported Event|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
11169767|NCT01993108|BG000|Baseline|Healthy Controls|"Healthy individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.~Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning.~Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning.~Placebo: One dose of placebo one hour before fMRI scanning."
11169768|NCT01993108|BG001|Baseline|Adult Attention-Deficit/Hyperactivity Disorder|"ADHD individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.~Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning.~Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning.~Placebo: One dose of placebo one hour before fMRI scanning."
11169769|NCT01993108|BG002|Baseline|Total|Total of all reporting groups
11174177|NCT02020018|OG000|Outcome|Prospective Group|Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
11169770|NCT01993108|FG000|Participant Flow|Healthy Controls|"Healthy individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.~Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning.~Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning.~Placebo: One dose of placebo one hour before fMRI scanning."
11169771|NCT01993108|FG001|Participant Flow|Adult Attention-Deficit/Hyperactivity Disorder|"ADHD individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.~Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning.~Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning.~Placebo: One dose of placebo one hour before fMRI scanning."
11169772|NCT01993108|OG000|Outcome|Methlyphenidate in Healthy Controls|40mg methylphenidate in Healthy Controls
11169773|NCT01993108|OG001|Outcome|Naltrexone in Healthy Controls|40mg Naltrexone in Healthy Controls
11169774|NCT01993108|OG002|Outcome|Placebo in Healthy Controls|Placebo Pill in Healthy Controls
11169775|NCT01993108|OG003|Outcome|Methlyphenidate in ADHD|40mg methylphenidate in ADHD
11169776|NCT01993108|OG004|Outcome|Naltrexone in ADHD|40mg naltrexone in ADHD
11169777|NCT01993108|OG005|Outcome|Placebo in ADHD|Placebo Pill in ADHD
11169778|NCT01993108|OG000|Outcome|Methlyphenidate in Healthy Controls|40mg methylphenidate in healthy controls
11169779|NCT01993108|OG001|Outcome|Naltrexone in Healthy Controls|40mg Naltrexone in healthy controls
11169780|NCT01993108|OG002|Outcome|Placebo in Healthy Controls|Placebo pill in healthy controls
11169781|NCT01993108|OG005|Outcome|Placebo in ADHD|placebo pill in ADHD
11169782|NCT01993108|OG002|Outcome|Placebo in Healthy Controls|Placebo pill in Healthy Controls
11169783|NCT01993108|OG003|Outcome|Methlyphenidate in ADHD|40mg methlyphenidate in ADHD
11356022|NCT03805971|FG000|Participant Flow|Patient Aged More Than 18 Years Admitted for Thoracoscopy|"Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies~Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool."
11356023|NCT03805971|OG000|Outcome|Benign Pleura|Participants with a benign pleura histological diagnosis.
11169784|NCT01993108|OG005|Outcome|Placebo in ADHD|Placebo pill in ADHD
11169785|NCT01993108|EG000|Reported Event|Methlyphenidate|40mg methylphenidate
11169786|NCT01993108|EG001|Reported Event|Naltrexone|40mg Naltrexone
11169787|NCT01993108|EG002|Reported Event|Placebo|Placebo
11169788|NCT01993186|BG000|Baseline|UX007|"Participants randomized to receive UX007 entered a 2-week dose titration period to achieve study drug treatment comprising up to 35% of total daily calories or to the maximum tolerated dose level and maintained at the 35% total daily calorie dose level for a 6-week treatment period.~Following completion of the Week 8 study visit, participants continued treatment with open-label UX007 at the 35% dose level for an additional 44 weeks (Weeks 8-52)."
11169789|NCT01993186|BG001|Baseline|Placebo|"Participants randomized to receive placebo entered a 2-week dose titration period to achieve study drug treatment comprising up to 35% of total daily calories or to the maximum tolerated dose level and maintained at the 35% total daily calorie dose level for a 6-week treatment period.~Following completion of the Week 8 study visit, placebo participants continued treatment with open-label UX007 at the 35% dose level for an additional 44 weeks (Weeks 8-52)."
11169790|NCT01993186|BG002|Baseline|Total|Total of all reporting groups
11169791|NCT01993186|FG000|Participant Flow|UX007|"Participants randomized to receive UX007 entered a 2-week dose titration period to achieve study drug treatment comprising up to 35% of total daily calories or to the maximum tolerated dose level and maintained at the 35% total daily calorie dose level for a 6-week treatment period.~Following completion of the Week 8 study visit, participants continued treatment with open-label UX007 at the 35% dose level for an additional 44 weeks (Weeks 8-52)."
11169792|NCT01993186|FG001|Participant Flow|Placebo|"Participants randomized to receive placebo entered a 2-week dose titration period to achieve study drug treatment comprising up to 35% of total daily calories or to the maximum tolerated dose level and maintained at the 35% total daily calorie dose level for a 6-week treatment period.~Following completion of the Week 8 study visit, placebo participants continued treatment with open-label UX007 at the 35% dose level for an additional 44 weeks (Weeks 8-52)."
11169793|NCT01993186|OG000|Outcome|UX007|"Participants randomized to receive UX007 entered a 2-week dose titration period to achieve study drug treatment comprising up to 35% of total daily calories or to the maximum tolerated dose level and maintained at the 35% total daily calorie dose level for a 6-week treatment period.~Following completion of the Week 8 study visit, participants continued treatment with open-label UX007 at the 35% dose level for an additional 44 weeks (Weeks 8-52)."
11169794|NCT01993186|OG001|Outcome|Placebo|"Participants randomized to receive placebo entered a 2-week dose titration period to achieve study drug treatment comprising up to 35% of total daily calories or to the maximum tolerated dose level and maintained at the 35% total daily calorie dose level for a 6-week treatment period.~Following completion of the Week 8 study visit, placebo participants continued treatment with open-label UX007 at the 35% dose level for an additional 44 weeks (Weeks 8-52)."
11169795|NCT01993186|EG000|Reported Event|Placebo Controlled Period / UX007|Participants randomized to receive UX007 entered a 2-week dose titration period to achieve study drug treatment comprising up to 35% of total daily calories or to the maximum tolerated dose level and maintained at the 35% total daily calorie dose level for a 6-week treatment period.
11169796|NCT01993186|EG001|Reported Event|Placebo Controlled Period / Placebo|Participants randomized to receive placebo entered a 2-week dose titration period to achieve study drug treatment comprising up to 35% of total daily calories or to the maximum tolerated dose level and maintained at the 35% total daily calorie dose level for a 6-week treatment period.
11169797|NCT01993186|EG002|Reported Event|Extension Period / UX007|Following completion of the Week 8 study visit, placebo and UX007 participants continued treatment with open-label UX007 at the 35% dose level for an additional 44 weeks (Weeks 8-52).
11356024|NCT03805971|OG001|Outcome|Malignant Pleural Infiltrations|Participants with a malignant pleural disease demonstrated by biopsies.
11169798|NCT01993238|BG000|Baseline|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
11169799|NCT01993238|FG000|Participant Flow|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
11356025|NCT03805971|EG000|Reported Event|Patient Aged More Than 18 Years Admitted for Thoracoscopy|"Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies~Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool."
11356026|NCT03802916|BG000|Baseline|Low Dosage|"Patients in this group will receive a total daily dosage of deferiprone DR tablets that is closer to 75 mg/kg/day. The total dosage will be divided into two equal parts, taken about 12 hours apart.~Deferiprone DR tablets 1000 mg (Low dosage): Deferiprone DR tablets 1000 mg"
10888009|NCT00504257|EG000|Reported Event|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
11169800|NCT01993238|OG000|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
11169801|NCT01993238|EG000|Reported Event|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
11169802|NCT01993329|BG000|Baseline|Gefapixant 50 mg>Gefapixant 300 mg>Placebo|Gefapixant 50 mg twice daily (BID) on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 2 followed by a washout period of ≥7 days, then Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169803|NCT01993329|BG001|Baseline|Gefapixant 50 mg>Placebo>Gefapixant 300 mg|Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169804|NCT01993329|BG002|Baseline|Gefapixant 300 mg>Gefapixant 50 mg>Placebo|Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169805|NCT01993329|BG003|Baseline|Gefapixant 300 mg>Placebo>Gefapixant 50 mg|Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169806|NCT01993329|BG004|Baseline|Placebo> Gefapixant 50 mg>Gefapixant 300 mg|Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169807|NCT01993329|BG005|Baseline|Placebo> Gefapixant 300 mg>Gefapixant 50 mg|Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169808|NCT01993329|BG006|Baseline|Total|Total of all reporting groups
11169809|NCT01993329|FG000|Participant Flow|Gefapixant 50 mg>Gefapixant 300 mg>Placebo|Gefapixant 50 mg twice daily (BID) on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 2 followed by a washout period of ≥7 days, then Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169810|NCT01993329|FG001|Participant Flow|Gefapixant 50 mg>Placebo>Gefapixant 300 mg|Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11356027|NCT03802916|BG001|Baseline|High Dosage|"Patients in this group will receive a total daily dosage of deferiprone DR tablets that is closer to 100 mg/kg/day. The total dosage will be divided into two equal parts, taken about 12 hours apart.~Deferiprone DR tablets 1000 mg (High dosage): Deferiprone DR tablets 1000 mg"
11356028|NCT03802916|BG002|Baseline|Total|Total of all reporting groups
11357430|NCT03758365|EG005|Reported Event|Desonide 0.05% Cream|"Single application of Desonide 0.05%~Desonide 0.05% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11169811|NCT01993329|FG002|Participant Flow|Gefapixant 300 mg>Gefapixant 50 mg>Placebo|Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169812|NCT01993329|FG003|Participant Flow|Gefapixant 300 mg>Placebo>Gefapixant 50 mg|Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169813|NCT01993329|FG004|Participant Flow|Placebo> Gefapixant 50 mg>Gefapixant 300 mg|Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169814|NCT01993329|FG005|Participant Flow|Placebo> Gefapixant 300 mg>Gefapixant 50 mg|Placebo BID on Days 1-3 and once daily in the morning Day 4 in Period 1, followed by a washout period of ≥7 days, then Gefapixant 300 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 2, followed by a washout period of ≥7 days, then Gefapixant 50 mg BID on Days 1-3 and once daily in the morning Day 4 in Period 3
11169815|NCT01993329|OG000|Outcome|Gefapixant 50|Participants received gefapixant 50 mg twice daily for 3.5 days during one period of the study
11169816|NCT01993329|OG001|Outcome|Gefapixant 300|Participants received gefapixant 300 mg twice daily for 3.5 days during one period of the study
11169817|NCT01993329|OG002|Outcome|Placebo|Participants received placebo twice daily for 3.5 days during each period of the study
11169818|NCT01993329|OG000|Outcome|Screening|Screening (Day -21 to Day -1)
11169819|NCT01993329|OG001|Outcome|Gefapixant 50|Participants received gefapixant 50 mg twice daily for 3.5 days during one period of the study
11169820|NCT01993329|OG002|Outcome|Gefapixant 300|Participants received gefapixant 300 mg twice daily for 3.5 days during one period of the study
11169821|NCT01993329|OG003|Outcome|Placebo|Participants received placebo twice daily for 3.5 days during each period of the study
11169822|NCT01993329|EG000|Reported Event|Gefapixant 50 mg|Participants received gefapixant 50 mg twice daily for 3.5 days during one period of the study
11169823|NCT01993329|EG001|Reported Event|Gefapixant 300 mg|Participants received gefapixant 300 mg twice daily for 3.5 days during one period of the study
11169824|NCT01993329|EG002|Reported Event|Placebo|Participants received placebo twice daily for 3.5 days during each period of the study
11169825|NCT01993615|BG000|Baseline|Arthroscopic Surgery|"Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.~Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings."
11169826|NCT01993615|BG001|Baseline|Physical Therapy|"An impairment-based supervised in-clinic physical therapy program.~Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments."
11169827|NCT01993615|BG002|Baseline|Total|Total of all reporting groups
11169828|NCT01993615|FG000|Participant Flow|Arthroscopic Surgery|"Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.~Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings."
11169829|NCT01993615|FG001|Participant Flow|Physical Therapy|"An impairment-based supervised in-clinic physical therapy program.~Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments."
11169830|NCT01993615|OG000|Outcome|Arthroscopic Surgery|"Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.~Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings."
11169831|NCT01993615|OG001|Outcome|Physical Therapy|"An impairment-based supervised in-clinic physical therapy program.~Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments."
11169832|NCT01993615|EG000|Reported Event|Arthroscopic Surgery|"Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.~Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings."
11169833|NCT01993615|EG001|Reported Event|Physical Therapy|"An impairment-based supervised in-clinic physical therapy program.~Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments."
11169834|NCT01993667|BG000|Baseline|Acetazolamide Normal Dose|"Experimental : Acetazolamide 125 mg twice daily~Acetazolamide: Administration of low dose acetazolamide"
11169835|NCT01993667|BG001|Baseline|Acetazolamide Low Dose|"Experimental: Acetazolamide 62.5 mg twice daily~Acetazolamide: Administration of low dose acetazolamide"
11356029|NCT03802916|FG000|Participant Flow|Low Dosage|"Patients in this group will receive a total daily dosage of deferiprone DR tablets that is closer to 75 mg/kg/day. The total dosage will be divided into two equal parts, taken about 12 hours apart.~Deferiprone DR tablets 1000 mg (Low dosage): Deferiprone DR tablets 1000 mg"
11356030|NCT03802916|FG001|Participant Flow|High Dosage|"Patients in this group will receive a total daily dosage of deferiprone DR tablets that is closer to 100 mg/kg/day. The total dosage will be divided into two equal parts, taken about 12 hours apart.~Deferiprone DR tablets 1000 mg (High dosage): Deferiprone DR tablets 1000 mg"
11356031|NCT03802916|OG000|Outcome|Low Dosage|Evaluable patients who received the lower dosage of deferiprone
11356032|NCT03802916|OG001|Outcome|High Dosage|Evaluable patients who received the higher dosage of deferiprone
11169836|NCT01993667|BG002|Baseline|Total|Total of all reporting groups
11169837|NCT01993667|FG000|Participant Flow|Acetazolamide Normal Dose|"Experimental : Acetazolamide 125 mg twice daily~Acetazolamide: Administration of low dose acetazolamide"
11169838|NCT01993667|FG001|Participant Flow|Acetazolamide Low Dose|"Experimental: Acetazolamide 62.5 mg twice daily~Acetazolamide: Administration of low dose acetazolamide"
11169839|NCT01993667|OG000|Outcome|Acetazolamide Normal Dose|"Experimental : Acetazolamide 125 mg twice daily~Acetazolamide: Administration of low dose acetazolamide"
11169840|NCT01993667|OG001|Outcome|Acetazolamide Low Dose|"Experimental: Acetazolamide 62.5 mg twice daily~Acetazolamide: Administration of low dose acetazolamide"
11169841|NCT01993667|EG000|Reported Event|Acetazolamide Normal Dose|"Experimental : Acetazolamide 125 mg twice daily~Acetazolamide: Administration of low dose acetazolamide"
11169842|NCT01993667|EG001|Reported Event|Acetazolamide Low Dose|"Experimental: Acetazolamide 62.5 mg twice daily~Acetazolamide: Administration of low dose acetazolamide"
11356033|NCT03802916|OG000|Outcome|Low Dosage|Patients who completed the questionnaire
11356034|NCT03802916|OG001|Outcome|High Dosage|Patients who completed the questionnaire
11169843|NCT01993823|BG000|Baseline|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
11356035|NCT03802916|EG000|Reported Event|Low Dosage|Evaluable patients who received the lower dosage of deferiprone
11356036|NCT03802916|EG001|Reported Event|High Dosage|Evaluable patients who received the higher dosage of deferiprone
11356037|NCT03809039|BG000|Baseline|Part 1 Placebo|Single dose
11356038|NCT03809039|BG001|Baseline|Part 1: MT-6345 1 mg|Single dose
11356039|NCT03809039|BG002|Baseline|Part 1: MT-6345 5 mg|Single dose
11356040|NCT03809039|BG003|Baseline|Part 1: MT-6345 20 mg|Single dose
11169844|NCT01993823|BG001|Baseline|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
11169845|NCT01993823|BG002|Baseline|Total|Total of all reporting groups
11169846|NCT01993823|FG000|Participant Flow|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
11169847|NCT01993823|FG001|Participant Flow|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
11169848|NCT01993823|OG000|Outcome|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
11169849|NCT01993823|OG001|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
11169850|NCT01993823|EG000|Reported Event|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
11169851|NCT01993823|EG001|Reported Event|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
11169852|NCT01993836|BG000|Baseline|General Anesthesia With Isoflurane|Surgical patients randomized to receive inhalational anesthesia with isoflurane during surgery
11169853|NCT01993836|BG001|Baseline|Total Intravenous Anesthesia With Propofol|Surgical patients randomized to receive iintravenous anesthesia with propofol during surgery
11169854|NCT01993836|BG002|Baseline|Non-Surgical Controls|Cohort of community dwelling healthy controls for tertiary comparison
11169855|NCT01993836|BG003|Baseline|Total|Total of all reporting groups
11169856|NCT01993836|FG000|Participant Flow|General Anesthesia With Isoflurane|Surgical patients randomized to receive inhalational anesthesia with isoflurane during surgery
11169857|NCT01993836|FG001|Participant Flow|Total Intravenous Anesthesia With Propofol|Surgical patients randomized to receive intravenous anesthesia with propofol during surgery
11356041|NCT03809039|BG004|Baseline|Part 1: MT-6345 60 mg|Single dose
11356042|NCT03809039|BG005|Baseline|Part 1: MT-6345 120 mg|Single dose
11356043|NCT03809039|BG006|Baseline|Part 1: MT-6345 240 mg|Single dose
11356044|NCT03809039|BG007|Baseline|Part 3 Placebo|Multiple dose
11356045|NCT03809039|BG008|Baseline|Part 3: MT-6345 60 mg|Multiple dose
11356046|NCT03809039|BG009|Baseline|Total|Total of all reporting groups
11356047|NCT03809039|FG000|Participant Flow|Part 1 and Part 2 Placebo|Single dose
11356048|NCT03809039|FG001|Participant Flow|Part 1: MT-6345 1 mg|Single dose
11356049|NCT03809039|FG002|Participant Flow|Part 1: MT-6345 5 mg|Single dose
11356050|NCT03809039|FG003|Participant Flow|Part 1 and Part 2: MT-6345 20 mg|Single dose
11356051|NCT03809039|FG004|Participant Flow|Part 1: MT-6345 60 mg|Single dose
11356052|NCT03809039|FG005|Participant Flow|Part 1: MT-6345 120 mg|Single dose
11356053|NCT03809039|FG006|Participant Flow|Part 1: MT-6345 240 mg|Single dose
11356054|NCT03809039|FG007|Participant Flow|Part 3: Placebo|Multiple dose
11356055|NCT03809039|FG008|Participant Flow|Part 3: MT-6345 60 mg|Multiple dose
11356056|NCT03809039|OG000|Outcome|Part 1 Placebo|Single dose
11356057|NCT03809039|OG001|Outcome|Part 1: MT-6345 1 mg|Single dose
11356058|NCT03809039|OG002|Outcome|Part 1: MT-6345 5 mg|Single dose
11356059|NCT03809039|OG003|Outcome|Part 1: MT-6345 20 mg|Single dose
11356060|NCT03809039|OG004|Outcome|Part 1: MT-6345 60 mg|Single dose
11356061|NCT03809039|OG005|Outcome|Part 1: MT-6345 120 mg|Single dose
11356062|NCT03809039|OG006|Outcome|Part 1: MT-6345 240 mg|Single dose
11169858|NCT01993836|FG002|Participant Flow|Non-Surgical Controls|Cohort of community dwelling healthy controls for tertiary comparison
11169859|NCT01993836|OG000|Outcome|Combined Surgical Cohort|The combination of both surgical randomized treatment groups.
11169860|NCT01993836|OG000|Outcome|Total Intravenous Anesthesia With Propofol|"Patients in this arm will receive general anesthesia with propofol as the primary amnestic agent.~Total intravenous anesthesia with propofol"
11356063|NCT03809039|OG007|Outcome|Part 2: Placebo|Single dose
11169861|NCT01993836|OG001|Outcome|General Anesthesia With Isoflurane|"Patients in this arm will undergo general anesthesia with isoflurane as the primary amnestic agent.~General anesthesia with isoflurane"
11169862|NCT01993836|EG000|Reported Event|General Anesthesia With Isoflurane|Surgical patients randomized to receive inhalational anesthesia with isoflurane during surgery
11169863|NCT01993836|EG001|Reported Event|Total Intravenous Anesthesia With Propofol|Surgical patients randomized to receive iintravenous anesthesia with propofol during surgery
11169864|NCT01993836|EG002|Reported Event|Non-Surgical Controls|Cohort of community dwelling healthy controls for comparison
11169865|NCT01993849|BG000|Baseline|N-Acetylcysteine (NAC)|"1200 mg twice daily dosing for 8 weeks~N-Acetylcysteine (NAC)"
11169866|NCT01993849|BG001|Baseline|Placebo|"Twice daily dosing for 8 weeks~Placebo"
11169867|NCT01993849|BG002|Baseline|Total|Total of all reporting groups
11169868|NCT01993849|FG000|Participant Flow|N-Acetylcysteine|"Twice daily dosing for 8 weeks~N-Acetylcysteine (NAC)"
11169869|NCT01993849|FG001|Participant Flow|Placebo|"Twice daily dosing for 8 weeks~Placebo"
11169870|NCT01993849|OG000|Outcome|N-Acetylcysteine (NAC)|"Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks~N-Acetylcysteine (NAC): This is the medication N-acetylcysteine (NAC)"
11169871|NCT01993849|OG001|Outcome|Placebo|"Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks~Placebo: Placebo, designed to match in appearance to NAC"
11169872|NCT01993849|OG000|Outcome|N-Acetylcysteine|"1200 mg twice daily dosing for 8 weeks~N-Acetylcysteine (NAC)"
11169873|NCT01993849|OG001|Outcome|Placebo|"Twice daily dosing for 8 weeks~Placebo"
11169874|NCT01993849|EG000|Reported Event|N-Acetylcysteine|"1200 mg twice daily dosing for 8 weeks~N-Acetylcysteine (NAC)"
11169875|NCT01993849|EG001|Reported Event|Placebo|"Twice daily dosing for 8 weeks~Placebo"
11169876|NCT01993875|BG000|Baseline|Lubiprostone|Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
11169877|NCT01993875|BG001|Baseline|Placebo|Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
11169878|NCT01993875|BG002|Baseline|Total|Total of all reporting groups
11169879|NCT01993875|FG000|Participant Flow|Lubiprostone|Participants received liquid formulation of Lubiprostone drug, 12 microgram (mcg) x 2 pumps administered orally twice daily (BID).
11169880|NCT01993875|FG001|Participant Flow|Placebo|Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
11169881|NCT01993875|OG000|Outcome|Lubiprostone|Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
11169882|NCT01993875|OG001|Outcome|Placebo|Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
11169883|NCT01993875|OG000|Outcome|Lubiprostone|Participants received liquid formulation of Lubiprostone drug, 12 microgram (mcg) x 2 pumps administered orally twice daily (BID).
11169884|NCT01993875|EG000|Reported Event|Lubiprostone|Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
11169885|NCT01993875|EG001|Reported Event|Placebo|Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
11169886|NCT01993888|BG000|Baseline|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).~EVARREST™ Fibrin Sealant Patch"
11169887|NCT01993888|BG001|Baseline|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).~Standard of Care (SoC)"
11169888|NCT01993888|BG002|Baseline|Total|Total of all reporting groups
11169889|NCT01993888|FG000|Participant Flow|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).~EVARREST™ Fibrin Sealant Patch"
11169890|NCT01993888|FG001|Participant Flow|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).~Standard of Care (SoC)"
11169891|NCT01993888|OG000|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
11169892|NCT01993888|OG001|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
11169893|NCT01993888|EG000|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
11174178|NCT02020018|OG001|Outcome|Retrospective Arm|Conventional sterile dry wound dressing applied immediately postoperatively.
11356064|NCT03809039|OG008|Outcome|Part 2: MT-6345 20 mg|Single dose
11356065|NCT03809039|OG009|Outcome|Part 3: Placebo|Multiple dose
11356066|NCT03809039|OG010|Outcome|Part 3: MT-6345 60 mg|Multiple dose
11356067|NCT03809039|OG000|Outcome|Part 1: MT-6345 1 mg|Single dose
11356068|NCT03809039|OG001|Outcome|Part 1: MT-6345 5 mg|Single dose
11356069|NCT03809039|OG002|Outcome|Part 1: MT-6345 20 mg|Single dose
11356070|NCT03809039|OG003|Outcome|Part 1: MT-6345 60 mg|Single dose
11356071|NCT03809039|OG004|Outcome|Part 1: MT-6345 120 mg|Single dose
11356072|NCT03809039|OG005|Outcome|Part 1: MT-6345 240 mg|Single dose
11356073|NCT03809039|OG006|Outcome|Part 2: MT-6345 20 mg|Single dose
11356074|NCT03809039|OG007|Outcome|Part 3: MT-6345 60 mg|Multiple dose
11356075|NCT03809039|OG000|Outcome|Part 3: MT-6345 60 mg|Multiple dose
11169894|NCT01993888|EG001|Reported Event|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
11356076|NCT03809039|EG000|Reported Event|Part 1 Placebo|Single dose
11356077|NCT03809039|EG001|Reported Event|Part 1: MT-6345 1 mg|Single dose
11356078|NCT03809039|EG002|Reported Event|Part 1: MT-6345 5 mg|Single dose
11356079|NCT03809039|EG003|Reported Event|Part 1: MT-6345 20 mg|Single dose
11356080|NCT03809039|EG004|Reported Event|Part 1: MT-6345 60 mg|Single dose
11356081|NCT03809039|EG005|Reported Event|Part 1: MT-6345 120 mg|Single dose
11356082|NCT03809039|EG006|Reported Event|Part 1: MT-6345 240 mg|Single dose
11356083|NCT03809039|EG007|Reported Event|Part 2: Placebo|Single dose
11356084|NCT03809039|EG008|Reported Event|Part 2: MT-6345 20 mg|Single dose
11356085|NCT03809039|EG009|Reported Event|Part 3: Placebo|Multiple dose
11356086|NCT03809039|EG010|Reported Event|Part 3: MT-6345 60 mg|Multiple dose
11356087|NCT03807700|BG000|Baseline|Experimental Denture Adhesive|In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
11356088|NCT03807700|BG001|Baseline|No Adhesive|In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
11356089|NCT03807700|BG002|Baseline|Total|Total of all reporting groups
11356090|NCT03807700|FG000|Participant Flow|Experimental Denture Adhesive|In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
11356091|NCT03807700|FG001|Participant Flow|No Adhesive|In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
11356092|NCT03807700|OG000|Outcome|Experimental Denture Adhesive|In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
11356093|NCT03807700|OG001|Outcome|No Adhesive|In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
11356094|NCT03807700|EG000|Reported Event|Experimental Denture Adhesive|In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
11356095|NCT03807700|EG001|Reported Event|No Adhesive|In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
11356096|NCT03807700|EG002|Reported Event|Overall|Included all participants that were assessed for safety adverse events.
11356097|NCT03804918|BG000|Baseline|Interventional Group: All Participants|"Given access to a selected breaking bad news mobile learning resource (VitalTips application).~VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments."
11356098|NCT03804918|FG000|Participant Flow|Interventional Group: All Participants|"Given access to a selected breaking bad news mobile learning resource (VitalTips application).~VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments."
11356099|NCT03804918|OG000|Outcome|Interventional Group: All Participants|"Given access to a selected breaking bad news mobile learning resource (VitalTips application).~VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments."
11356100|NCT03804918|EG000|Reported Event|Interventional Group: All Participants|"Given access to a selected breaking bad news mobile learning resource (VitalTips application).~VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments."
11356101|NCT03805386|BG000|Baseline|Standard of Care|"Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.~Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided."
11356102|NCT03805386|BG001|Baseline|Patient Directed Care|"Subject directed arm will be prescribed the number of opioids that the patient decides based on a shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.~Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care."
11356103|NCT03805386|BG002|Baseline|Total|Total of all reporting groups
11356104|NCT03805386|FG000|Participant Flow|Standard of Care|"Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.~Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided."
11356105|NCT03805386|FG001|Participant Flow|Patient Directed Care|"Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.~Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care."
11356106|NCT03805386|OG000|Outcome|Standard of Care|"Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.~Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided."
11356107|NCT03805386|OG001|Outcome|Patient Directed Care|"Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.~Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care."
11356108|NCT03805386|OG000|Outcome|# Pills Prescribed Standard|The number of 5mg oxycodone pills prescribed to patients at the preoperative visit.
11169895|NCT01993927|BG000|Baseline|Voglibose 0.2 mg or OD Tablets 0.2 mg|Voglibose 0.2 mg or OD Tablets 0.2 mg was administered orally three times daily immediately before each meal, up to 72 months (approximately 1 year and 6 months). Participants will receive interventions as part of routine medical care.
11169896|NCT01993927|FG000|Participant Flow|Voglibose 0.2 mg or OD Tablets 0.2 mg|Voglibose 0.2 mg or OD Tablets 0.2 mg was administered orally three times daily immediately before each meal, up to 72 months (approximately 1 year and 6 months). Participants will receive interventions as part of routine medical care.
11356109|NCT03805386|OG001|Outcome|# Pills Prescribed Patient Directed|# of 5mg oxycodone pills prescribed based on shared decision making.
11356110|NCT03805386|OG001|Outcome|Patient Directed Care|"Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.~Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care."
11356111|NCT03805386|EG000|Reported Event|Standard of Care|"Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.~Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided."
11356112|NCT03805386|EG001|Reported Event|Patient Directed Care|"Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.~Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care."
11356113|NCT03803475|BG000|Baseline|Ga-68 Labeled PSMA-11 PET PSMA|Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
11356114|NCT03803475|FG000|Participant Flow|Ga-68 Labeled PSMA-11 PET PSMA|Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
11356115|NCT03803475|OG000|Outcome|Ga-68 Labeled PSMA-11 PET PSMA|Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
11356116|NCT03803475|EG000|Reported Event|Ga-68 Labeled PSMA-11 PET PSMA|Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
11356117|NCT03802227|BG000|Baseline|NKTR-181|Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR oxycodone IR
11356118|NCT03802227|BG001|Baseline|Oxycodone IR 40 mg|One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181
11356119|NCT03802227|BG002|Baseline|Total|Total of all reporting groups
11169897|NCT01993927|OG000|Outcome|Voglibose 0.2 mg or OD Tablets 0.2 mg|Voglibose 0.2 mg or OD Tablets 0.2 mg was administered orally three times daily immediately before each meal, up to 72 months (approximately 1 year and 6 months). Participants will receive interventions as part of routine medical care.
11169898|NCT01993927|EG000|Reported Event|Voglibose 0.2 mg or OD Tablets 0.2 mg|Voglibose 0.2 mg or OD Tablets 0.2 mg was administered orally three times daily immediately before each meal, up to 72 months (approximately 1 year and 6 months). Participants will receive interventions as part of routine medical care.
11356120|NCT03802227|FG000|Participant Flow|NKTR-181|Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR
11356121|NCT03802227|FG001|Participant Flow|Oxycodone IR 40 mg|Once capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181
11356122|NCT03802227|OG000|Outcome|NKTR-181|Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR
11356123|NCT03802227|OG001|Outcome|Oxycodone IR 40 mg|One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181
11356124|NCT03802227|OG000|Outcome|NKTR-181|NKTR-181 400 mg and placebo for oxycodone IR one tablet of each once
11356125|NCT03802227|OG001|Outcome|Oxycodone IR 40 mg|Oxycodone IR 40 mg and placebo for NKTR-181 one tablet of each once
11356126|NCT03802227|EG000|Reported Event|NKTR-181|Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR
11356127|NCT03802227|EG001|Reported Event|Oxycodone IR 40 mg|One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181
11356128|NCT03802864|BG000|Baseline|Liposomal Bupivacaine|"Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.~Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief."
11356129|NCT03802864|BG001|Baseline|Standard Bupivacaine|"Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.~Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief."
11356130|NCT03802864|BG002|Baseline|Total|Total of all reporting groups
11356131|NCT03802864|FG000|Participant Flow|Liposomal Bupivacaine|"Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.~Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief."
11356132|NCT03802864|FG001|Participant Flow|Standard Bupivacaine|"Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.~Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief."
11356133|NCT03802864|OG000|Outcome|Liposomal Bupivacaine|"Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.~Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief."
11356134|NCT03802864|OG001|Outcome|Standard Bupivacaine|"Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.~Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief."
11356135|NCT03802864|EG000|Reported Event|Liposomal Bupivacaine|"Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.~Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief."
11356136|NCT03802864|EG001|Reported Event|Standard Bupivacaine|"Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.~Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief."
11356137|NCT03801265|BG000|Baseline|Lumbar Plexus Block|"0.5% ropivacaine 100 mg (20 ml) will be injected~Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.~Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups."
11356138|NCT03801265|BG001|Baseline|Quadratus Lumborum Type 3 Block|"0.5% ropivacaine 100 mg (20 ml) will be injected~Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.~Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups."
11356139|NCT03801265|BG002|Baseline|Total|Total of all reporting groups
11356140|NCT03801265|FG000|Participant Flow|Lumbar Plexus Block|"0.5% ropivacaine 100 mg (20 ml) will be injected~Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.~Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups."
11169899|NCT01993940|BG000|Baseline|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
11356141|NCT03801265|FG001|Participant Flow|Quadratus Lumborum Type 3 Block|"0.5% ropivacaine 100 mg (20 ml) will be injected~Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.~Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups."
11356142|NCT03801265|OG000|Outcome|Lumbar Plexus Block|"0.5% ropivacaine 100 mg (20 ml) will be injected~Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.~Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups."
11356143|NCT03801265|OG001|Outcome|Quadratus Lumborum Type 3 Block|"0.5% ropivacaine 100 mg (20 ml) will be injected~Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.~Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups."
11356144|NCT03801265|EG000|Reported Event|Lumbar Plexus Block|"0.5% ropivacaine 100 mg (20 ml) will be injected~Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.~Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups."
11356145|NCT03801265|EG001|Reported Event|Quadratus Lumborum Type 3 Block|"0.5% ropivacaine 100 mg (20 ml) will be injected~Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.~Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups."
11356146|NCT03802344|BG000|Baseline|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream"
11356147|NCT03802344|BG001|Baseline|Cal/BDP Combination|"Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks~Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%"
11356148|NCT03802344|BG002|Baseline|Vehicle|"One application daily for 8 weeks~Vehicle: Vehicle"
11356149|NCT03802344|BG003|Baseline|Total|Total of all reporting groups
10888010|NCT00504309|BG000|Baseline|4 g P-OM3, 1 g P-OM3, Placebo|4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks
11356150|NCT03802344|FG000|Participant Flow|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream"
11356151|NCT03802344|FG001|Participant Flow|Cal/BDP Combination|"Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks~Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%"
11356152|NCT03802344|FG002|Participant Flow|Vehicle|"One application daily for 8 weeks~Vehicle: Vehicle"
11356153|NCT03802344|OG000|Outcome|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream"
11356154|NCT03802344|OG001|Outcome|Cal/BDP Combination|"Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks~Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%"
11356155|NCT03802344|OG002|Outcome|Vehicle|"One application daily for 8 weeks~Vehicle: Vehicle"
11356156|NCT03802344|OG002|Outcome|Vehicle|"One application daily for 8 weeks~Vehicle: Vehicle cream"
11356157|NCT03802344|EG000|Reported Event|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream"
10888011|NCT00504309|BG001|Baseline|1 g P-OM3, 4 g P-OM3, Placebo|1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks
11356158|NCT03802344|EG001|Reported Event|Cal/BDP Combination|"Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks~Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%"
11356159|NCT03802344|EG002|Reported Event|Vehicle|"One application daily for 8 weeks~Vehicle: Vehicle"
11356160|NCT03801928|BG000|Baseline|UC: New Inflectra|Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356161|NCT03801928|BG001|Baseline|UC: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11356162|NCT03801928|BG002|Baseline|UC: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356163|NCT03801928|BG003|Baseline|CD: New Inflectra|Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356164|NCT03801928|BG004|Baseline|CD: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11169900|NCT01993940|BG001|Baseline|Placebo|Participants received placebo orally once daily for 12 weeks.
11356165|NCT03801928|BG005|Baseline|CD: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356166|NCT03801928|BG006|Baseline|Total|Total of all reporting groups
11356167|NCT03801928|FG000|Participant Flow|UC: New Inflectra|Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356168|NCT03801928|FG001|Participant Flow|UC: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11356169|NCT03801928|FG002|Participant Flow|UC: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356170|NCT03801928|FG003|Participant Flow|CD: New Inflectra|Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356171|NCT03801928|FG004|Participant Flow|CD: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11356172|NCT03801928|FG005|Participant Flow|CD: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356173|NCT03801928|OG000|Outcome|UC: New Inflectra|Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356174|NCT03801928|OG001|Outcome|UC: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11356175|NCT03801928|OG002|Outcome|UC: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356176|NCT03801928|OG003|Outcome|CD: New Inflectra|Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356177|NCT03801928|OG004|Outcome|CD: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11356178|NCT03801928|OG005|Outcome|CD: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356179|NCT03801928|OG000|Outcome|CD: New Inflectra|Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356180|NCT03801928|OG001|Outcome|CD: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11356181|NCT03801928|OG002|Outcome|CD: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356182|NCT03801928|EG000|Reported Event|UC: New Inflectra|Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356183|NCT03801928|EG001|Reported Event|UC: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11169901|NCT01993940|BG002|Baseline|Total|Total of all reporting groups
11356184|NCT03801928|EG002|Reported Event|UC: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356185|NCT03801928|EG003|Reported Event|CD: New Inflectra|Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.
11356186|NCT03801928|EG004|Reported Event|CD: Inflectra After Remicade|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.
11356187|NCT03801928|EG005|Reported Event|CD: Inflectra After Other Biologics|Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
11356188|NCT03800173|BG000|Baseline|Placebo|single placebo IV infusion
11356189|NCT03800173|BG001|Baseline|5 mg/kg Galidesivir|Single IV infusion 5 mg/kg galidesivir
11356190|NCT03800173|BG002|Baseline|10 mg/kg Galidesivir|Single IV infusion 10 mg/kg galidesivir
11356191|NCT03800173|BG003|Baseline|15 mg/kg Galidesivir|Single IV infusion 15 mg/kg galidesivir
11356192|NCT03800173|BG004|Baseline|20 mg/kg Galidesivir|Single IV infusion 20 mg/kg galidesivir
11356193|NCT03800173|BG005|Baseline|Total|Total of all reporting groups
11356194|NCT03800173|FG000|Participant Flow|Placebo|single placebo IV infusion
11356195|NCT03800173|FG001|Participant Flow|5 mg/kg Galidesivir|Single IV infusion 5 mg/kg galidesivir
11356196|NCT03800173|FG002|Participant Flow|10 mg/kg Galidesivir|Single IV infusion 10 mg/kg galidesivir
11356197|NCT03800173|FG003|Participant Flow|15 mg/kg Galidesivir|Single IV infusion 15 mg/kg galidesivir
11356198|NCT03800173|FG004|Participant Flow|20 mg/kg Galidesivir|Single IV infusion 20 mg/kg galidesivir
11356199|NCT03800173|OG000|Outcome|Placebo|single placebo IV infusion
11356200|NCT03800173|OG001|Outcome|5 mg/kg Galidesivir|Single IV infusion 5 mg/kg galidesivir
11356201|NCT03800173|OG002|Outcome|10 mg/kg Galidesivir|Single IV infusion 10 mg/kg galidesivir
11356202|NCT03800173|OG003|Outcome|15 mg/kg Galidesivir|Single IV infusion 15 mg/kg galidesivir
11356203|NCT03800173|OG004|Outcome|20 mg/kg Galidesivir|Single IV infusion 20 mg/kg galidesivir
11356204|NCT03800173|OG000|Outcome|5 mg/kg Galidesivir|Single IV infusion 5 mg/kg galidesivir
11356205|NCT03800173|OG001|Outcome|10 mg/kg Galidesivir|Single IV infusion 10 mg/kg galidesivir
11356206|NCT03800173|OG002|Outcome|15 mg/kg Galidesivir|Single IV infusion 15 mg/kg galidesivir
11356207|NCT03800173|OG003|Outcome|20 mg/kg Galidesivir|Single IV infusion 20 mg/kg galidesivir
11356208|NCT03800173|EG000|Reported Event|Placebo|single placebo IV infusion
11356209|NCT03800173|EG001|Reported Event|5 mg/kg Galidesivir|Single IV infusion 5 mg/kg galidesivir
11356210|NCT03800173|EG002|Reported Event|10 mg/kg Galidesivir|Single IV infusion 10 mg/kg galidesivir
11356211|NCT03800173|EG003|Reported Event|15 mg/kg Galidesivir|Single IV infusion 15 mg/kg galidesivir
11356212|NCT03800173|EG004|Reported Event|20 mg/kg Galidesivir|Single IV infusion 20 mg/kg galidesivir
11356213|NCT03799783|BG000|Baseline|Dexmedetomidine|"2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion~dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete"
11356214|NCT03799783|FG000|Participant Flow|Dexmedetomidine|"2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion~dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete"
11356215|NCT03799783|OG000|Outcome|Dexmedetomidine|"2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion~dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete"
11356216|NCT03799783|EG000|Reported Event|Dexmedetomidine|"2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion~dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete"
11356217|NCT03800030|BG000|Baseline|All Participants|Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
11356218|NCT03800030|FG000|Participant Flow|Theta-gamma, Delta-beta, Sham|"Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.~Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS~Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus~Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus~Sham tACS: NeuroConn technologies, direct current-stimulator plus"
11356219|NCT03800030|FG001|Participant Flow|Theta-gamma, Sham, Delta-beta|"Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.~Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS~Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus~Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus~Sham tACS: NeuroConn technologies, direct current-stimulator plus"
11356220|NCT03800030|FG002|Participant Flow|Delta-beta, Theta-gamma, Sham tACS|"Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.~Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS~Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus~Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus~Sham tACS: NeuroConn technologies, direct current-stimulator plus"
11357431|NCT03758365|EG006|Reported Event|Vehicle Cream|"Single application of Vehicle~Vehicle: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation"
11356221|NCT03800030|FG003|Participant Flow|Delta-beta, Sham, Theta-gamma tACS|"Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.~Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS~Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus~Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus~Sham tACS: NeuroConn technologies, direct current-stimulator plus"
11356222|NCT03800030|FG004|Participant Flow|Sham, Delta-beta, Theta-gamma tACS|"Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.~Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS~Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus~Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus~Sham tACS: NeuroConn technologies, direct current-stimulator plus"
11356223|NCT03800030|FG005|Participant Flow|Sham, Theta-gamma, Delta-beta tACS|"Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.~Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS~Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus~Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus~Sham tACS: NeuroConn technologies, direct current-stimulator plus"
11356224|NCT03800030|OG000|Outcome|Theta-gamma tACS|Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
11356225|NCT03800030|OG001|Outcome|Delta-beta tACS|Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
11356226|NCT03800030|OG002|Outcome|Sham tACS|Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
11356227|NCT03800030|EG000|Reported Event|Theta-gamma tACS|Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
11356228|NCT03800030|EG001|Reported Event|Delta-beta tACS|Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
11356229|NCT03800030|EG002|Reported Event|Sham tACS|Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
11356230|NCT03799211|BG000|Baseline|Motivational Interviewing|Motivational Interviewing: Phone call using motivational interviewing technique
11169902|NCT01993940|FG000|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
11169903|NCT01993940|FG001|Participant Flow|Placebo|Participants received placebo orally once daily for 12 weeks.
11356231|NCT03799211|BG001|Baseline|Usual Care|Treatment as Usual: will receive a regular study phone call after three months
11356232|NCT03799211|BG002|Baseline|Total|Total of all reporting groups
11356233|NCT03799211|FG000|Participant Flow|Motivational Interviewing|Motivational Interviewing: Phone call using motivational interviewing technique
11356234|NCT03799211|FG001|Participant Flow|Usual Care|Treatment as Usual: will receive a regular study phone call after three months
11356235|NCT03799211|OG000|Outcome|Motivational Interviewing|Motivational Interviewing: Phone call using motivational interviewing technique
11356236|NCT03799211|OG001|Outcome|Usual Care|Treatment as Usual: will receive a regular study phone call after three months
11356237|NCT03799211|OG000|Outcome|Usual Care|Treatment as Usual: will receive a regular study phone call after three months
11356238|NCT03799211|OG001|Outcome|Motivational Interviewing|Motivational Interviewing: Phone call using motivational interviewing technique
11356239|NCT03799211|EG000|Reported Event|Motivational Interviewing|Motivational Interviewing: Phone call using motivational interviewing technique
11356240|NCT03799211|EG001|Reported Event|Usual Care|Treatment as Usual: will receive a regular study phone call after three months
11356241|NCT03798717|BG000|Baseline|Control - Pre OGTT - Post OGTT|Participants first underwent a 3 h OGTT with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
11356242|NCT03798717|BG001|Baseline|Control - Post OGTT - Pre OGTT|Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
11356243|NCT03798717|BG002|Baseline|Pre OGTT - Control - Post OGTT|Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
10888012|NCT00504309|BG002|Baseline|Placebo, 4 g P-OM3, 1 g P-OM3|4 g/d corn oil placebo for 8 weeks, followed by 4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks
11169904|NCT01993940|OG000|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
11169905|NCT01993940|OG001|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
11356244|NCT03798717|BG003|Baseline|Pre OGTT - Post OGTT - Control|Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
11356245|NCT03798717|BG004|Baseline|Post OGTT - Control - Pre OGTT|Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
11356246|NCT03798717|BG005|Baseline|Post OGTT - Pre OGTT - Control|Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
11356247|NCT03798717|BG006|Baseline|Total|Total of all reporting groups
11356248|NCT03798717|FG000|Participant Flow|Control - Pre OGTT - Post OGTT|Participants first underwent a 3 h OGTT (oral glucose tolerance test) with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
11356249|NCT03798717|FG001|Participant Flow|Control - Post OGTT - Pre OGTT|Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
11356250|NCT03798717|FG002|Participant Flow|Pre OGTT - Control - Post OGTT|Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
11356251|NCT03798717|FG003|Participant Flow|Pre OGTT - Post OGTT - Control|Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
11356252|NCT03798717|FG004|Participant Flow|Post OGTT - Control - Pre OGTT|Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
11356253|NCT03798717|FG005|Participant Flow|Post OGTT - Pre OGTT - Control|Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
11089850|NCT01525615|BG001|Baseline|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11089851|NCT01525615|BG002|Baseline|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11089852|NCT01525615|BG003|Baseline|Total|Total of all reporting groups
11089853|NCT01525615|FG000|Participant Flow|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
11356254|NCT03798717|OG000|Outcome|Control|Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR (heart rate) will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
11356255|NCT03798717|OG001|Outcome|Pre OGTT|"Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.~Heating: Warm water immersion"
11356256|NCT03798717|OG002|Outcome|Post OGTT|"Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.~Heating: Warm water immersion"
11356257|NCT03798717|OG000|Outcome|Control|Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
11089854|NCT01525615|FG001|Participant Flow|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11089855|NCT01525615|FG002|Participant Flow|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11089856|NCT01525615|OG000|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
11089857|NCT01525615|OG001|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11089858|NCT01525615|OG002|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11089859|NCT01525615|EG000|Reported Event|Placebo|once daily 2 puffs, solution for inhalation Respimat placebo to tiotropium+olodaterol: comparator
11356258|NCT03798717|EG000|Reported Event|Control|Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
11089860|NCT01525615|EG001|Reported Event|Tio+Olo 2.5 / 5.0 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11169906|NCT01993940|EG000|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
11169907|NCT01993940|EG001|Reported Event|Placebo|Participants received placebo orally once daily for 12 weeks.
11356259|NCT03798717|EG001|Reported Event|Pre OGTT|"Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.~Heating: Warm water immersion"
11356260|NCT03798717|EG002|Reported Event|Post OGTT|"Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.~Heating: Warm water immersion"
11356261|NCT03798483|BG000|Baseline|Individualized Exercise|"Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist~Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used."
11356262|NCT03798483|FG000|Participant Flow|Individualized Exercise|"Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist~Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used."
11356263|NCT03798483|OG000|Outcome|Patients With a Diagnosed Lateral Patellar Dislocation|Patients with a clinically diagnosed lateral patellar dislocation
11356264|NCT03798483|OG000|Outcome|Individualized Exercise|"Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist~Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used."
11356265|NCT03798483|OG000|Outcome|Participants Who Completed and Returned Follow-up Outcome Data|11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants
11356266|NCT03798483|OG000|Outcome|Individualized Exercise|"Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist~Individualised exercise: The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used."
11356267|NCT03798483|OG000|Outcome|Patients Who Returned Lysholm Knee Scoring Scale Outcome Data|13 participants returned Lysholm Knee Scoring Scale data, for 2 of these participants outcome data was obtained by phone
11169908|NCT01994109|BG000|Baseline|MYOBLOC 2500 U|Subjects were dosed per treatment assignment of 2500 U MYOBLOC.
11169909|NCT01994109|BG001|Baseline|MYOBLOC 3500 U|Subjects were dosed per treatment assignment of 3500 U MYOBLOC.
11169910|NCT01994109|BG002|Baseline|PLACEBO|Placebo was dosed as an exact match of MYOBLOC.
11357432|NCT03758157|BG000|Baseline|Temperature Measurement|"welloStationX: welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.~SureTemp: SureTemp is an oral thermometer to measure human body skin temperature."
11169911|NCT01994109|BG003|Baseline|Total|Total of all reporting groups
11169912|NCT01994109|FG000|Participant Flow|DB: MYOBLOC 2500 U|Participants will receive specified dose of MYOBLOC
11169913|NCT01994109|FG001|Participant Flow|DB: MYOBLOC 3500 U|Participants will receive specified dose of MYOBLOC
11169914|NCT01994109|FG002|Participant Flow|DB: Placebo|Participants will receive volume matched Placebo
11169915|NCT01994109|FG003|Participant Flow|OL: ALL MYOBLOC|All Participants were to receive 3500 U MYOBLOC but could receive lower doses at investigator discretion.
11169916|NCT01994109|OG000|Outcome|MYOBLOC 2500 U|Subjects were dosed per treatment assignment of 2500 U MYOBLOC.
11169917|NCT01994109|OG001|Outcome|MYOBLOC 3500 U|Subjects were dosed per treatment assignment of 3500 U MYOBLOC
11169918|NCT01994109|OG002|Outcome|Placebo|Placebo was dosed as an exact match of MYOBLOC.
11357433|NCT03758157|FG000|Participant Flow|welloStationX Automated Non-Contact Thermometer|welloStationX: welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.
11356268|NCT03798483|EG000|Reported Event|Individualized Exercise|"Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist~Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used."
11356269|NCT03798366|BG000|Baseline|GLPG1690 600 mg|Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
11356270|NCT03798366|BG001|Baseline|Placebo|Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
11356271|NCT03798366|BG002|Baseline|Total|Total of all reporting groups
11356272|NCT03798366|FG000|Participant Flow|GLPG1690 600 mg|Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks.
11356273|NCT03798366|FG001|Participant Flow|Placebo|Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
11356274|NCT03798366|OG000|Outcome|GLPG1690 600 mg|Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
11356275|NCT03798366|OG001|Outcome|Placebo|Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
11356276|NCT03798366|EG000|Reported Event|GLPG1690 600 mg|Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
11356277|NCT03798366|EG001|Reported Event|Placebo|Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
11356278|NCT03799952|BG000|Baseline|Intervention|"Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.~Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour."
11356279|NCT03799952|BG001|Baseline|Control|"Participants are instructed to continue with their daily activities and their normal physical activity levels for 12-weeks."
11356280|NCT03799952|BG002|Baseline|Total|Total of all reporting groups
11356281|NCT03799952|FG000|Participant Flow|Intervention|"Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.~Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour."
11356282|NCT03799952|FG001|Participant Flow|Control|"Participants are instructed to continue with their daily activities and their normal physical activity levels for 12-weeks."
11356283|NCT03799952|OG000|Outcome|Intervention|"Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.~Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour."
11356284|NCT03799952|OG001|Outcome|Control|"Participants are instructed to continue with their daily activities and their normal physical activity levels for 12-weeks."
11356285|NCT03799952|EG000|Reported Event|Intervention|"Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.~Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour."
11356286|NCT03799952|EG001|Reported Event|Control|"Participants are instructed to continue with their daily activities and their normal physical activity levels for 12-weeks."
11356287|NCT03797872|BG000|Baseline|Standard Care|"Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.~Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc~Sulfasalazine: Sulfasalazine up to 3g daily po~Leflunomide: Leflunomide 10-20mg daily po"
11356288|NCT03797872|BG001|Baseline|Local/IM Steroid Injections|"Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).~Methylprednisolone: For IA or IM injection 20-120mg~Triamcinolone: For IA or IM injection 20-120mg"
11356289|NCT03797872|BG002|Baseline|Total|Total of all reporting groups
11356290|NCT03797872|FG000|Participant Flow|Standard Care|"Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.~Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc~Sulfasalazine: Sulfasalazine up to 3g daily po~Leflunomide: Leflunomide 10-20mg daily po"
11357434|NCT03758157|OG000|Outcome|Temperature Measurement|Each subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer.
11356291|NCT03797872|FG001|Participant Flow|Local/IM Steroid Injections|"Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).~Methylprednisolone: For IA or IM injection 20-120mg~Triamcinolone: For IA or IM injection 20-120mg"
11356292|NCT03797872|OG000|Outcome|Standard Care|"Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.~Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc~Sulfasalazine: Sulfasalazine up to 3g daily po~Leflunomide: Leflunomide 10-20mg daily po"
11356293|NCT03797872|OG001|Outcome|Local/IM Steroid Injections|"Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).~Methylprednisolone: For IA or IM injection 20-120mg~Triamcinolone: For IA or IM injection 20-120mg"
11356294|NCT03797872|EG000|Reported Event|Standard Care|"Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.~Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc~Sulfasalazine: Sulfasalazine up to 3g daily po~Leflunomide: Leflunomide 10-20mg daily po"
11356295|NCT03797872|EG001|Reported Event|Local/IM Steroid Injections|"Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).~Methylprednisolone: For IA or IM injection 20-120mg~Triamcinolone: For IA or IM injection 20-120mg"
11356296|NCT03799614|BG000|Baseline|Lower Dose Vibration|"RMBand lower dose vibration~RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm"
11356297|NCT03799614|BG001|Baseline|Higher Dose Vibration|"RMBand higher dose vibration~RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm"
11356298|NCT03799614|BG002|Baseline|Total|Total of all reporting groups
11356299|NCT03799614|FG000|Participant Flow|Low Dose Vibration|"RMBand lower dose vibration~RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm"
11356300|NCT03799614|FG001|Participant Flow|High Dose Vibration|"RMBand higher dose vibration~RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm"
11356301|NCT03799614|OG000|Outcome|Low Dose Vibration|"RMBand low dose vibration~RMBand: Light-weight portable device that delivers low dose vibration to the arm"
11356302|NCT03799614|OG001|Outcome|Higher Dose Vibration|"RMBand high dose vibration~RMBand: Light-weight portable device that delivers higher dose vibration to the arm"
11356303|NCT03799614|OG000|Outcome|Lower Dose Vibration|"RMBand lower dose vibration~RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm"
11169919|NCT01994109|OG001|Outcome|MYOBLOC 3500 U|Subjects were dosed per treatment assignment of 3500 U MYOBLOC.
11356304|NCT03799614|OG001|Outcome|Higher Dose Vibration|"RMBand higher dose vibration~RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm"
11356305|NCT03799614|OG000|Outcome|Low Dose Vibration Amplitude|"RMBand low dose vibration~RMBand: Light-weight portable device that delivers low dose vibration to the arm,reported in mm."
11356306|NCT03799614|EG000|Reported Event|Lower Dose Vibration|"RMBand lower dose vibration~RMBand lower dose: Light-weight portable device that delivers low dose vibration (frequency of 80 Hz) to the arm"
11356307|NCT03799614|EG001|Reported Event|Higher Dose Vibration|"RMBand higher dose vibration~RMBand higher dose: Light-weight portable device that delivers higher dose (frequency of 160 Hz) vibration to the arm"
11356308|NCT03799484|BG000|Baseline|All Participants|2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.
11356309|NCT03799484|FG000|Participant Flow|All Participants|2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.
11356310|NCT03799484|OG000|Outcome|Topical Anesthesia|"2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection~Botulinum toxin type A: Botulinum toxin type A will be administered to both sides~2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead"
11356311|NCT03799484|OG001|Outcome|Petrolatum|"Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection~Botulinum toxin type A: Botulinum toxin type A will be administered to both sides~petrolatum ointment: petrolatum ointment will be applied to one side of the forehead"
11356312|NCT03799484|OG000|Outcome|All Participants|2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.
11356313|NCT03799484|EG000|Reported Event|Topical Anesthesia|"2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection~Botulinum toxin type A: Botulinum toxin type A will be administered to both sides~2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead"
11356314|NCT03799484|EG001|Reported Event|Petrolatum|"Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection~Botulinum toxin type A: Botulinum toxin type A will be administered to both sides~petrolatum ointment: petrolatum ointment will be applied to one side of the forehead"
11356315|NCT03796728|BG000|Baseline|Juvéderm® VOLIFT™ With Lidocaine|Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
11356316|NCT03796728|FG000|Participant Flow|Juvéderm® VOLIFT™ With Lidocaine|Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
11356317|NCT03796728|OG000|Outcome|Juvéderm® VOLIFT™ With Lidocaine|Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
11356318|NCT03796728|EG000|Reported Event|Juvéderm® VOLIFT™ With Lidocaine|Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
11356319|NCT03797144|BG000|Baseline|Degenerative Spinal Disease|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
11356320|NCT03797144|BG001|Baseline|Deformity|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
11356321|NCT03797144|BG002|Baseline|Total|Total of all reporting groups
11356322|NCT03797144|FG000|Participant Flow|Degenerative Spinal Disease|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
11356323|NCT03797144|FG001|Participant Flow|Deformity|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
11356324|NCT03797144|OG000|Outcome|Degenerative Spinal Disease|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
11356325|NCT03797144|OG001|Outcome|Deformity|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
11356326|NCT03797144|OG000|Outcome|Deformity|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
11356327|NCT03797144|EG000|Reported Event|Degenerative Spinal Disease|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
11356328|NCT03797144|EG001|Reported Event|Deformity|Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
11356329|NCT03782571|BG000|Baseline|Total|All subjects dispensed a study lens.
11356330|NCT03782571|FG000|Participant Flow|Test 1\Control\Test 2\Test 3|Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, and Test 3 in period 4.
11356331|NCT03782571|FG001|Participant Flow|Test 2\Test 1\Test 3\Control|Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, and Control in period 4.
11356332|NCT03782571|FG002|Participant Flow|Control\Test 3\Test 1\Test 2|Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 3 in period 2, Test 1 in period 3, and Test 2 in period 4.
11356333|NCT03782571|FG003|Participant Flow|Test 3\Test 2\Control\Test 1|Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Control in period 3, and 1 Test 1 in period 4.
11356334|NCT03782571|OG000|Outcome|Test 1|Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
11356335|NCT03782571|OG001|Outcome|Test 2|Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
11356336|NCT03782571|OG002|Outcome|Test 3|Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
11356337|NCT03782571|OG003|Outcome|Control (Bare Eye)|Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.
11356338|NCT03782571|OG000|Outcome|Total|All subjects dispensed a study lens.
11356339|NCT03782571|OG004|Outcome|Total|All subjects dispensed a study lens.
11356340|NCT03782571|EG000|Reported Event|Test 1|Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
11356341|NCT03782571|EG001|Reported Event|Test 2|Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
11356342|NCT03782571|EG002|Reported Event|Test 3|Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
11356343|NCT03782571|EG003|Reported Event|Control (Bare Eye)|Subjects were under bare eye condition in either the first, second, third, or fourth period of the study.
11356344|NCT03796260|BG000|Baseline|F1 to F06 Crossover|Participants first randomized to F1/F06 arm and received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F06 (reference formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356345|NCT03796260|BG001|Baseline|F06 to F1 Crossover|Participants first randomized to this arm received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F1 (test formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356346|NCT03796260|BG002|Baseline|Total|Total of all reporting groups
11356347|NCT03796260|FG000|Participant Flow|F1 to F06 Crossover|Participants first randomized to F1/F06 arm and received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F06 (reference formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356348|NCT03796260|FG001|Participant Flow|F06 to F1 Crossover|Participants first randomized to this arm received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F1 (test formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356349|NCT03796260|OG000|Outcome|F1 Test Formulation|Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).
11356350|NCT03796260|OG001|Outcome|F06 Reference Formulation|Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).
11356351|NCT03796260|EG000|Reported Event|F1 Test Formulation|Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).
11356352|NCT03796260|EG001|Reported Event|F06 Reference Formulation|Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days).
11356353|NCT03796039|BG000|Baseline|Standing and Social Intervention|"Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.~Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday"
11356354|NCT03796039|BG001|Baseline|Control Group|Control group will receive social visits, but no exposure to standing
11356355|NCT03796039|BG002|Baseline|Total|Total of all reporting groups
11356356|NCT03796039|FG000|Participant Flow|Standing and Social Intervention|"Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.~Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday"
11356357|NCT03796039|FG001|Participant Flow|Control Group|Control group will receive social visits, but no exposure to standing
11356358|NCT03796039|OG000|Outcome|Standing and Social Intervention|"Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.~Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday"
11356359|NCT03796039|OG001|Outcome|Control Group|Control group will receive social visits, but no exposure to standing
11356360|NCT03796039|EG000|Reported Event|Standing and Social Intervention|"Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.~Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday"
11356361|NCT03796039|EG001|Reported Event|Control Group|Control group will receive social visits, but no exposure to standing
11356362|NCT03783780|BG000|Baseline|INVSENSOR00031|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
11356363|NCT03783780|FG000|Participant Flow|INVSENSOR00031|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
11356364|NCT03783780|OG000|Outcome|INVSENSOR00031|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor.
11169920|NCT01994109|EG000|Reported Event|MYOBLOC 2500 U (Part A)|Participants received specified dose of MYOBLOC. Participants were evaluated for 13 weeks following the injection.
11169921|NCT01994109|EG001|Reported Event|MYOBLOC 3500 U (Part A)|Participants received specified dose of MYOBLOC. Participants were evaluated for 13 weeks following the injection.
11356365|NCT03783780|OG000|Outcome|INVSENSOR00031|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor.~INVSENSOR00031: Noninvasive pulse oximeter sensor"
11356366|NCT03783780|EG000|Reported Event|INVSENSOR00031|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
11356367|NCT03780959|BG000|Baseline|Part 1: Etanercept 0.4 mg/kg|Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1.
11356368|NCT03780959|BG001|Baseline|Part 2: Placebo|In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.
11356369|NCT03780959|BG002|Baseline|Part 2: Etanercept 0.4 mg/kg|In Part 2 participants were randomized to continue receiving 0.4 mg/kg etanercept twice weekly for up to 4 additional months.
11356370|NCT03780959|BG003|Baseline|Total|Total of all reporting groups
11356371|NCT03780959|FG000|Participant Flow|Part 1: Etanercept 0.4 mg/kg|Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1.
11356372|NCT03780959|FG001|Participant Flow|Part 2: Placebo|In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.
11356373|NCT03780959|FG002|Participant Flow|Part 2: Etanercept 0.4 mg/kg|In Part 2 participants were randomized to continue receiving 0.4 mg/kg etanercept twice weekly for up to 4 additional months.
11356374|NCT03780959|OG000|Outcome|Part 2: Placebo|In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.
10888013|NCT00504309|BG003|Baseline|4 g P-OM3, Placebo, 1 g P-OM3|4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks
11356375|NCT03780959|OG001|Outcome|Part 2: Etanercept 0.4 mg/kg|In Part 2 participants were randomized to continue receiving 0.4 mg/kg etanercept twice weekly for up to 4 additional months.
11356376|NCT03780959|OG000|Outcome|Part 1: Etanercept 0.4 mg/kg|Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1.
11356377|NCT03780959|OG001|Outcome|Part 2: Placebo|In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.
11356378|NCT03780959|OG002|Outcome|Part 2: Etanercept 0.4 mg/kg|In Part 2 participants were randomized to continue receiving 0.4 mg/kg etanercept twice weekly for up to 4 additional months.
11356379|NCT03780959|EG000|Reported Event|Part 1: Etanercept 0.4 mg/kg|Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1.
11356380|NCT03780959|EG001|Reported Event|Part 2: Placebo|n Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.
10888014|NCT00504309|BG004|Baseline|1 g P-OM3, Placebo, 4 g P-OM3|1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks
11169922|NCT01994109|EG002|Reported Event|Placebo (Part A)|Participants received volume matched Placebo. Participants were evaluated for 13 weeks following the injection.
11169923|NCT01994109|EG003|Reported Event|OL: ALL MYOBLOC (Part B)|Participants received Open Label treatment with 3500 U (decreased dose at investigator discretion) every 13 weeks for a maximum of 4 treatment sessions.
11356381|NCT03780959|EG002|Reported Event|Part 2: Etanercept 0.4 mg/kg|In Part 2 participants were randomized to continue receiving 0.4 mg/kg etanercept twice weekly for up to 4 additional months.
11356382|NCT03796182|BG000|Baseline|All Participants|This reporting group refers to the total 12 participants who were enrolled in the study.
11356383|NCT03796182|FG000|Participant Flow|Metformin Then Metformin + PF-04965842|Participants were administered a single oral dose of metformin 500 mg on Day 1 in Period 1 followed by a washout period of at least 4 days. Then in Period 2 participants were administered a single oral dose of metformin 500 mg on Day 1 along with oral doses of PF-04965842 200 mg once daily (QD) for 2 days on Days 1-2.
11356384|NCT03796182|FG001|Participant Flow|Metformin + PF-04965842 Then Metformin|Participants were administered a single oral dose of metformin 500 mg on Day 1 along with oral doses of PF-04965842 200 mg QD for 2 days on Days 1-2 in Period 1 followed by a washout period of at least 4 days. Then in Period 2 participants were administered a single oral dose of metformin 500 mg on Day 1.
11356385|NCT03796182|OG000|Outcome|Metformin + PF-04965842|This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
11356386|NCT03796182|OG001|Outcome|Metformin|This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
11356387|NCT03796182|EG000|Reported Event|Metformin + PF-04965842|This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
11356388|NCT03796182|EG001|Reported Event|Metformin|This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
11356389|NCT03796013|BG000|Baseline|Form A to Form C Crossover|Participants first randomized to this arm received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 1. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356390|NCT03796013|BG001|Baseline|Form C to Form A Crossover|Participants first randomized to this arm received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 1. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356391|NCT03796013|BG002|Baseline|Total|Total of all reporting groups
11356392|NCT03796013|FG000|Participant Flow|Form A to Form C Crossover|Participants first randomized to this arm received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 1. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356393|NCT03796013|FG001|Participant Flow|Form C to Form A Crossover|Participants first randomized to this arm received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 1. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356394|NCT03796013|OG000|Outcome|Form A Reference Formulation|Participants who received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 1 and Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356395|NCT03796013|OG001|Outcome|Form C Test Formulation|Participants who received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 1 and Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356396|NCT03796013|EG000|Reported Event|Form A Reference Formulation|Participants who received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 1 and Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356397|NCT03796013|EG001|Reported Event|Form C Test Formulation|Participants who received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 1 and Day 1 of Period 2 (Periods 1 and 2 = 6 days).
11356398|NCT03795753|BG000|Baseline|F2S Communicator|"The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.~F2S Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
11356399|NCT03795753|BG001|Baseline|Non-functioning Communicator|"Non-functioning study communication device is used.~Non-functioning Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
11169924|NCT01994226|BG000|Baseline|Low-dose Colchicine|"500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet - Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days"
11169925|NCT01994226|BG001|Baseline|Naproxen|"Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
11169926|NCT01994226|BG002|Baseline|Total|Total of all reporting groups
11169927|NCT01994226|FG000|Participant Flow|Low-dose Colchicine|"500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet - Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days"
11169928|NCT01994226|FG001|Participant Flow|Naproxen|"Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
11169929|NCT01994226|OG000|Outcome|Low-dose Colchicine|"500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet - Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days"
11356400|NCT03795753|BG002|Baseline|Total|Total of all reporting groups
11356401|NCT03795753|FG000|Participant Flow|F2S Communicator|"The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.~F2S Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
11169930|NCT01994226|OG001|Outcome|Naproxen|"Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
11169931|NCT01994226|EG000|Reported Event|Low-dose Colchicine|"500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet - Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days"
11169932|NCT01994226|EG001|Reported Event|Naproxen|"Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
11169933|NCT01994291|BG000|Baseline|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
11169934|NCT01994291|BG001|Baseline|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
11356402|NCT03795753|FG001|Participant Flow|Non-functioning Communicator|"Non-functioning study communication device is used.~Non-functioning Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
11356403|NCT03795753|OG000|Outcome|F2S Communicator|"The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.~F2S Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
11356404|NCT03795753|OG001|Outcome|Non-functioning Communicator|"Non-functioning study communication device is used.~Non-functioning Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
11356405|NCT03795753|EG000|Reported Event|F2S Communicator|"The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.~F2S Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
11356406|NCT03795753|EG001|Reported Event|Non-functioning Communicator|"Non-functioning study communication device is used.~Non-functioning Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
11356407|NCT03792477|BG000|Baseline|Part 1: Treatment A>Treatment B|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B.
11356408|NCT03792477|BG001|Baseline|Part 1: Treatment B>Treatment A|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A.
11356409|NCT03792477|BG002|Baseline|Part 2: Treatment A>Treatment B>Treatment B|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B.
11356410|NCT03792477|BG003|Baseline|Part 2: Treatment B>Treatment A>Treatment B|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B.
11356411|NCT03792477|BG004|Baseline|Part 2: Treatment B>Treatment B>Treatment A|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A.
11356412|NCT03792477|BG005|Baseline|Total|Total of all reporting groups
11356413|NCT03792477|FG000|Participant Flow|Part 1: Treatment A>Treatment B|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (intramuscular [IM]) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B.
11356414|NCT03792477|FG001|Participant Flow|Part 1: Treatment B>Treatment A|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A.
11169935|NCT01994291|BG002|Baseline|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
10888015|NCT00504309|BG005|Baseline|Placebo, 1 g P-OM3, 4 g P-OM3|4 g/d corn oil placebo for 8 weeks, followed by 1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks
11169936|NCT01994291|BG003|Baseline|Total|Total of all reporting groups
11356415|NCT03792477|FG002|Participant Flow|Part 2: Treatment A>Treatment B>Treatment B|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B.
11356416|NCT03792477|FG003|Participant Flow|Part 2: Treatment B>Treatment A>Treatment B|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B.
11356417|NCT03792477|FG004|Participant Flow|Part 2: Treatment B>Treatment B>Treatment A|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A.
11356418|NCT03792477|OG000|Outcome|Treatment A|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
11356419|NCT03792477|OG001|Outcome|Treatment B|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
11356420|NCT03792477|EG000|Reported Event|Treatment A (Parts 1 and 2)|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This group included the participants enrolled in both Part 1 and Part 2 of the study.
11356421|NCT03792477|EG001|Reported Event|Treatment B (Parts 1 and 2)|This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This group included the participants enrolled in both Part 1 and Part 2 of the study.
11356422|NCT03783962|BG000|Baseline|Active Intervention - Cooking|"Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the University of Vermont Nutrition and Food Sciences department foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.~Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.~Twelve cooking classes will be run every other week after the in-person weight loss meetings."
11356423|NCT03783962|BG001|Baseline|Demonstrations - Cooking|"The demonstration condition will serve as an attention only control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to even out the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.~Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking."
11356424|NCT03783962|BG002|Baseline|Total|Total of all reporting groups
10888016|NCT00504309|BG006|Baseline|Total|Total of all reporting groups
11089861|NCT01525615|EG002|Reported Event|Tio+Olo 5.0 / 5.0 μg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
11356425|NCT03783962|FG000|Participant Flow|Active Intervention - Cooking|"Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.~Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.~Twelve cooking classes will be run every other week after the in-person weight loss meetings."
11356426|NCT03783962|FG001|Participant Flow|Demonstrations - Cooking|"The demonstration condition will serve as an attention only control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to even out the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.~Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking."
11356427|NCT03783962|OG000|Outcome|Active Intervention - Cooking|"Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.~Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.~Twelve cooking classes will be run every other week after the in-person weight loss meetings."
11356428|NCT03783962|OG001|Outcome|Demonstrations - Cooking|"The demonstration condition will serve as an attention only control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to even out the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.~Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking."
11169937|NCT01994291|FG000|Participant Flow|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
11169938|NCT01994291|FG001|Participant Flow|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
11169939|NCT01994291|FG002|Participant Flow|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
11169940|NCT01994291|OG000|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
11169941|NCT01994291|OG001|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
11169942|NCT01994291|OG002|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
11169943|NCT01994291|OG003|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
11169944|NCT01994291|EG000|Reported Event|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
11169945|NCT01994291|EG001|Reported Event|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
11169946|NCT01994291|EG002|Reported Event|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
11169947|NCT01994395|BG000|Baseline|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
11174179|NCT02020018|EG000|Reported Event|Prospective Group|Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
11174180|NCT02020018|EG001|Reported Event|Retrospective Arm|Conventional sterile dry wound dressing applied immediately postoperatively.
11356429|NCT03783962|EG000|Reported Event|Active Intervention - Cooking|"Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.~Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.~Twelve cooking classes will be run every other week after the in-person weight loss meetings."
11356430|NCT03783962|EG001|Reported Event|Demonstrations - Cooking|"The demonstration condition will serve as an attention only control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to even out the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.~Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking."
11356431|NCT03782272|BG000|Baseline|AA-ORS|"Those receiving enterade oral re-hydration solution with amino acids~Enterade: enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes."
11356432|NCT03782272|BG001|Baseline|Placebo|"Those receiving placebo solution without amino acids or rehydration salts~Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water."
11356433|NCT03782272|BG002|Baseline|Total|Total of all reporting groups
11356434|NCT03782272|FG000|Participant Flow|AA-ORS|"Those receiving enterade oral re-hydration solution with amino acids~Enterade: enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes."
11356435|NCT03782272|FG001|Participant Flow|Placebo|"Those receiving placebo solution without amino acids or rehydration salts~Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water."
11356436|NCT03782272|OG000|Outcome|AA-ORS|"Those receiving enterade oral re-hydration solution with amino acids~Enterade: enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes."
11356437|NCT03782272|OG001|Outcome|Placebo|"Those receiving placebo solution without amino acids or rehydration salts~Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water."
11356438|NCT03782272|OG000|Outcome|Pooled Arms|Due to study termination, insufficient data was collected for per-arm analysis. Only 2 participants completed the study per-protocol with a total of 12 having at least one dose of study product (target sample size was 66). Both AA-ORS and placebo arms data are pooled together.
11356439|NCT03782272|EG000|Reported Event|AA-ORS|"Those receiving enterade oral re-hydration solution with amino acids~Enterade: enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes."
11356440|NCT03782272|EG001|Reported Event|Placebo|"Those receiving placebo solution without amino acids or rehydration salts~Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water."
11356441|NCT03779724|BG000|Baseline|Isokinetic Exercise|"The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.~exercises"
11356442|NCT03779724|BG001|Baseline|Home Exercise|"The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.~exercises"
11356443|NCT03779724|BG002|Baseline|Total|Total of all reporting groups
11089862|NCT01525628|BG000|Baseline|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
11174181|NCT02020031|BG000|Baseline|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
11356444|NCT03779724|FG000|Participant Flow|Isokinetic Exercise|"The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.~exercises"
11356445|NCT03779724|FG001|Participant Flow|Home Exercise|"The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.~exercises"
11356446|NCT03779724|OG000|Outcome|Isokinetic Exercise Baseline|"The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.~exercises"
11356447|NCT03779724|OG001|Outcome|Isokinetic Exercise After Treatment|the outcome measurements of isokinetic exercises group after the treatment
11356448|NCT03779724|OG002|Outcome|Home Exercise Baseline|"The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.~exercises"
11356449|NCT03779724|OG003|Outcome|Home Exercise After Treatment|the outcome measurements of home exercises group after the treatment
11356450|NCT03779724|EG000|Reported Event|Isokinetic Exercise|"The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.~exercises"
11356451|NCT03779724|EG001|Reported Event|Home Exercise|"The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.~exercises"
11356452|NCT03775915|BG000|Baseline|Real Neurofeedback|"3 sessions of Real Neurofeedback over 1 week~Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner."
11356453|NCT03775915|BG001|Baseline|Sham Neurofeedback|"3 sessions of Sham Neurofeedback over 1 week~Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant"
11356454|NCT03775915|BG002|Baseline|Total|Total of all reporting groups
11356455|NCT03775915|FG000|Participant Flow|Real Neurofeedback|"3 sessions of Real Neurofeedback over 1 week~Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner."
11356456|NCT03775915|FG001|Participant Flow|Sham Neurofeedback|"3 sessions of Sham Neurofeedback over 1 week~Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant"
11356457|NCT03775915|OG000|Outcome|Real Neurofeedback|"3 sessions of Real Neurofeedback over 1 week~Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner."
10888017|NCT00504309|FG000|Participant Flow|4g P-OM3, Then 1g P-OM3, Then Placebo|4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks)
11356458|NCT03775915|OG001|Outcome|Sham Neurofeedback|"3 sessions of Sham Neurofeedback over 1 week~Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant"
11356459|NCT03775915|EG000|Reported Event|Real Neurofeedback|"3 sessions of Real Neurofeedback over 1 week~Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner."
11356460|NCT03775915|EG001|Reported Event|Sham Neurofeedback|"3 sessions of Sham Neurofeedback over 1 week~Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant"
11356461|NCT03794752|BG000|Baseline|Vision Aided by a Head Mounted Device|Head-Mounted Visual Enhancement Device: Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black & white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use).
10888018|NCT00504309|FG001|Participant Flow|1g P-OM3, Then 4g P-OM3, Then Placebo|1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks
10888019|NCT00504309|FG002|Participant Flow|Placebo, Then 4g P-OM3, Then 1g P-OM3|Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks
10888020|NCT00504309|FG003|Participant Flow|4g P-OM3, Then Placebo, Then 1g P-OM3|4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks
11356462|NCT03794752|FG000|Participant Flow|Use of Head Mounted Device|"Evergaze has developed a head-mounted visual enhancement device for low-vision patients. Patients will be non-randomized individuals diagnosed with either Retinal Degeneration or diabetic macular edema with ETDRS (Early Treatment Diabetic Retinopathy Study) VA 20/60 to 20/400.~The device will be placed over the most degraded eye incorporating a camera, mounted coaxially with the visual axis of the eye with the worse vision. Incorporation of a video recording of head and eye movement with the head mounted device is being included for any functionality improvements to be made. Then each subject will undergo complete examination of their eyes, including ETDRS VA, distance and near along with Questions 5,6,7,and 11 of the NEI (National Eye Institute) 25 item visual function questionnaire (NEI VFQ 25)"
11356463|NCT03794752|OG000|Outcome|Vision Aided by a Head Mounted Device|"ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected visual acuity (BCVA) will be determined for each participant using the following conditions.~1. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device."
11356464|NCT03794752|OG000|Outcome|Vision Aided by a Head Mounted Device|"ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected near visual acuity (BCNVA) will be determined for each participant using the following conditions.~1. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device."
11356465|NCT03794752|OG000|Outcome|Vision Aided by a Head Mounted Device|"Reading speed is measured by using a standard paragraph. English Paragraph Reference: 3-Minute Reading Assessments, Rasinski TV and Padak N, 2005. Scholastic Inc., NY.~This outcome examines change in reading speed of the participant in two separate conditions:~1. Baseline reading - no use of the head-mounted electronic visual enhancement device. and 2. reading using head-mounted electronic visual enhancement device."
11356466|NCT03794752|OG000|Outcome|Vision Aided by a Head Mounted Device|"Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions will be determined for each participant using the following conditions.~1. Using the head-mounted electronic visual enhancement device. 2. Without using the head-mounted electronic visual enhancement device."
11356467|NCT03794752|OG000|Outcome|Vision Aided by a Head Mounted Device|Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded. Data will record change in response speed to identify shapes and objects under 2 conditions; 1. with the participant using the head-mounted electronic visual enhancement device and 2. with the participant not using the head-mounted electronic visual enhancement device .
11356468|NCT03794752|EG000|Reported Event|Use of Head Mounted Device|"Evergaze has developed a head-mounted visual enhancement device for low-vision patients. Patients will be non-randomized individuals diagnosed with either Retinal Degeneration or diabetic macular edema with ETDRS (Early Treatment Diabetic Retinopathy Study) VA 20/60 to 20/400.~The device will be placed over the most degraded eye incorporating a camera, mounted coaxially with the visual axis of the eye with the worse vision. Incorporation of a video recording of head and eye movement with the head mounted device is being included for any functionality improvements to be made. Then each subject will undergo complete examination of their eyes, including ETDRS VA, distance and near along with Questions 5,6,7,and 11 of the NEI (National Eye Institute) 25 item visual function questionnaire (NEI VFQ 25)"
11356469|NCT03793751|BG000|Baseline|DEX Group|Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
11356470|NCT03793751|BG001|Baseline|CONTROL Group|The Control Group will receive placebo infusion of normal saline.
11356471|NCT03793751|BG002|Baseline|Total|Total of all reporting groups
11356472|NCT03793751|FG000|Participant Flow|DEX Group|Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
11356473|NCT03793751|FG001|Participant Flow|CONTROL Group|The Control Group will receive placebo infusion of normal saline.
11356474|NCT03793751|OG000|Outcome|DEX Group|Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
11356475|NCT03793751|OG001|Outcome|CONTROL Group|The Control Group will receive placebo infusion of normal saline.
10851314|NCT00305760|EG000|Reported Event|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|"Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.~Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.~Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles."
11174182|NCT02020031|BG001|Baseline|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
11174183|NCT02020031|BG002|Baseline|Total|Total of all reporting groups
11356476|NCT03793751|EG000|Reported Event|DEX Group|Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
11356477|NCT03793751|EG001|Reported Event|CONTROL Group|The Control Group will receive placebo infusion of normal saline.
11356478|NCT03793556|BG000|Baseline|GERDOFF® + Omeprazole|"GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).~GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg"
11356479|NCT03793556|BG001|Baseline|Omeprazole|"Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).~Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast"
11356480|NCT03793556|BG002|Baseline|Total|Total of all reporting groups
11356481|NCT03793556|FG000|Participant Flow|GERDOFF® + Omeprazole|"GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).~GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg"
11356482|NCT03793556|FG001|Participant Flow|Omeprazole|"Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).~Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast"
11356483|NCT03793556|OG000|Outcome|GERDOFF® + Omeprazole|"GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).~GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg"
11356484|NCT03793556|OG001|Outcome|Omeprazole|"Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).~Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast"
11356485|NCT03793556|OG000|Outcome|GERDOFF® + Omeprazole|"GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment will last 6 weeks (+/- 2 days).~GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg"
11356486|NCT03793556|OG001|Outcome|Omeprazole|"Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment will last 6 weeks (+/- 2 days).~Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast"
11356487|NCT03793556|OG001|Outcome|No Treated|"Responder patients of Group Gerdoff® + omeprazole were randomly assigned to the control group.~All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks."
10851315|NCT00305773|BG000|Baseline|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
11356488|NCT03793556|EG000|Reported Event|GERDOFF® + Omeprazole|"GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).~GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg"
11356489|NCT03793556|EG001|Reported Event|Omeprazole|"Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).~Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast"
11356490|NCT03785548|BG000|Baseline|Mirror Group|"This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.~Usage of a mirror: using a mirror during the pelvic examination"
11356491|NCT03785548|BG001|Baseline|No Mirror Group|This group of patients decline a mirror, and they will undergo the standard pelvic examination.
11356492|NCT03785548|BG002|Baseline|Total|Total of all reporting groups
11356493|NCT03785548|FG000|Participant Flow|Mirror Group|"This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.~Usage of a mirror: using a mirror during the pelvic examination"
11356494|NCT03785548|FG001|Participant Flow|No Mirror Group|This group of patients decline a mirror, and they will undergo the standard pelvic examination.
11356495|NCT03785548|OG000|Outcome|Mirror Group|"This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.~Usage of a mirror: using a mirror during the pelvic examination"
11356496|NCT03785548|OG001|Outcome|No Mirror Group|This group of patients decline a mirror, and they will undergo the standard pelvic examination.
11356497|NCT03785548|EG000|Reported Event|Mirror Group|"This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.~Usage of a mirror: using a mirror during the pelvic examination"
11356498|NCT03785548|EG001|Reported Event|No Mirror Group|This group of patients decline a mirror, and they will undergo the standard pelvic examination.
11356499|NCT03782701|BG000|Baseline|All Participants|All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.
11356500|NCT03782701|FG000|Participant Flow|All Participants|All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.
11356501|NCT03782701|OG000|Outcome|Lumify Eye Drop|"Participants will be randomized to receive a single drop of Lumify to either the left or right eye.~Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)"
11356502|NCT03782701|OG001|Outcome|Saline Solution Eye Drop|"Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.~Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)"
11356503|NCT03782701|EG000|Reported Event|Lumify Eye Drop|"Participants will be randomized to receive a single drop of Lumify to either the left or right eye.~Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)"
11356504|NCT03782701|EG001|Reported Event|Saline Solution Eye Drop|"Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.~Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)"
11356505|NCT03773133|BG000|Baseline|Screened Subjects|In the screening period, 8 subjects received a single i.v. injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 ug and a radioactivity dose range of 150-200 MBq for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.
11356506|NCT03773133|FG000|Participant Flow|Screened Subjects|In the screening period, 8 subjects received a single intravenous (i.v.) injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 micrograms (ug) and a radioactivity dose range of 150-200 Megabequerel (MBq) for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.
11356507|NCT03773133|OG000|Outcome|All Subjects - Phase I|In the core treatment period of Phase I, eligible subjects were to receive up to 2 i.v. administrations of 177Lu-satoreotide tetraxetan. A range of cumulative radioactivities from 9 to 12.9 Gigabecquerels of 177Lu-satoreotide tetraxetan, fractionated into 2 administrations 6 weeks apart, were planned to be tested.
11356508|NCT03773133|OG000|Outcome|All Subjects - Phase II|Subjects were to receive the recommended Phase II 177Lu-satoreotide tetraxetan treatment regimen based on the dose-response and exposure-response analyses of Phase I. It was expected that 2 treatment cycles of 177Lu-satoreotide tetraxetan would be administered in subjects enrolled in Phase II.
11356509|NCT03773133|EG000|Reported Event|68Ga-satoreotide Trizoxetan Safety Population|The 68Ga-satoreotide trizoxetan safety population included all subjects who received at least 1 dose of 68Ga-satoreotide trizoxetan.
10851316|NCT00305773|BG001|Baseline|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
10851317|NCT00305773|BG002|Baseline|Total|Total of all reporting groups
11356510|NCT03792672|BG000|Baseline|All Participants|TAK-653 placebo-matching tablets or TAK-653 0.5 mg low dose tablets or TAK-653 6 mg high dose tablets, orally, once, on Day 1 of respective Treatment Period 1, 2 or 3 and Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4. A Washout Period of at least 10 days was maintained between each treatment period.
11356511|NCT03792672|FG000|Participant Flow|Placebo + TAK-653 0.5 mg + TAK-653 6 mg + Ketamine 0.5 mg/kg|TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4. A Washout Period of at least 10 days was maintained between each treatment period.
11356512|NCT03792672|FG001|Participant Flow|Placebo + TAK-653 6 mg + TAK-653 0.5 mg + Ketamine 0.5 mg/kg|TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4. A Washout Period of at least 10 days was maintained between each treatment period.
11356513|NCT03792672|FG002|Participant Flow|TAK-653 0.5 mg + Placebo + TAK-653 6 mg + Ketamine 0.5 mg/kg|TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4. A Washout Period of at least 10 days was maintained between each treatment period.
11356514|NCT03792672|FG003|Participant Flow|TAK-653 0.5 mg + TAK-653 6 mg + Placebo + Ketamine 0.5 mg/kg|TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4. A Washout Period of at least 10 days was maintained between each treatment period.
11356515|NCT03792672|FG004|Participant Flow|TAK-653 6 mg + Placebo + TAK-653 0.5 mg + Ketamine 0.5 mg/kg|TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4. A Washout Period of at least 10 days was maintained between each treatment period.
11356516|NCT03792672|FG005|Participant Flow|TAK-653 6 mg + TAK-653 0.5 mg + Placebo + Ketamine 0.5 mg/kg|TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4. A Washout Period of at least 10 days was maintained between each treatment period.
11356517|NCT03792672|OG000|Outcome|Placebo|TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 1, 2 or 3 as per assigned treatment sequence.
11356518|NCT03792672|OG001|Outcome|TAK-653 0.5 mg|TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 1, 2 or 3 as per assigned treatment sequence.
11356519|NCT03792672|OG002|Outcome|TAK-653 6 mg|TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 1, 2 or 3 as per assigned treatment sequence.
11356520|NCT03792672|OG000|Outcome|Ketamine 0.5 mg/kg|Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4 in all 6 treatment sequences.
11356521|NCT03792672|EG000|Reported Event|Placebo|TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 1, 2 or 3 as per assigned treatment sequence.
11356522|NCT03792672|EG001|Reported Event|TAK-653 0.5 mg|TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 1, 2 or 3 as per assigned treatment sequence.
11356523|NCT03792672|EG002|Reported Event|TAK-653 6 mg|TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 1, 2 or 3 as per assigned treatment sequence.
11356524|NCT03792672|EG003|Reported Event|Ketamine 0.5 mg/kg|Ketamine 0.5 mg/kg, infusion, intravenously, once on Day 1 of Treatment Period 4 in all 6 treatment sequences.
11356525|NCT03786744|BG000|Baseline|ASD CB-MNC Injection.|"ASD CB-MNC injection from different donors and standard therapy.~ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.~Standard therapy.: The standard therapy can include drugs, special psychology training etc."
11356526|NCT03786744|BG001|Baseline|Standard Therapy.|"Patients with standard therapy as control group.~Standard therapy.: The standard therapy can include drugs, special psychology training etc."
11356527|NCT03786744|BG002|Baseline|Total|Total of all reporting groups
11356528|NCT03786744|FG000|Participant Flow|ASD CB-MNC Injection.|"ASD CB-MNC injection from different donors and standard therapy.~ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.~Standard therapy.: The standard therapy can include drugs, special psychology training etc."
11356529|NCT03786744|FG001|Participant Flow|Standard Therapy.|"Patients with standard therapy as control group.~Standard therapy.: The standard therapy can include drugs, special psychology training etc."
11356530|NCT03786744|OG000|Outcome|ASD CB-MNC Injection.|"ASD CB-MNC injection from different donors and standard therapy.~ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.~Standard therapy.: The standard therapy can include drugs, special psychology training etc."
11356531|NCT03786744|OG001|Outcome|Control Group|The standard therapy can include drugs, special psychology training etc.
11356532|NCT03786744|OG001|Outcome|Standard Therapy.|The standard therapy can include drugs, special psychology training etc.
11356533|NCT03786744|EG000|Reported Event|ASD CB-MNC Injection.|"ASD CB-MNC injection from different donors and standard therapy.~ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.~Standard therapy.: The standard therapy can include drugs, special psychology training etc."
11356534|NCT03786744|EG001|Reported Event|Standard Therapy.|"Patients with standard therapy as control group.~Standard therapy.: The standard therapy can include drugs, special psychology training etc."
11356535|NCT03782181|BG000|Baseline|Patients Perform Whole Body Vibration Plat|"An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.~Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform."
11356536|NCT03782181|BG001|Baseline|Control Group|No intervention arm
11356537|NCT03782181|BG002|Baseline|Total|Total of all reporting groups
11356538|NCT03782181|FG000|Participant Flow|Whole Body Vibration Plat|"An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.~Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform."
11356539|NCT03782181|FG001|Participant Flow|Control Group|No intervention arm
11356540|NCT03782181|OG000|Outcome|Whole Body Vibration Plat|"An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.~Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017"
11356541|NCT03782181|OG001|Outcome|Control Group|No intervention arm
11356542|NCT03782181|OG000|Outcome|Whole Body Vibration Plat|"An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.~Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform."
11356543|NCT03782181|EG000|Reported Event|Whole Body Vibration Plat|"An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.~Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform."
11356544|NCT03782181|EG001|Reported Event|Control Group|No intervention arm
11356545|NCT03792191|BG000|Baseline|Ultrasonography|"Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.~Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.~Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle~Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space~Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space"
11356546|NCT03792191|BG001|Baseline|Palpation|"Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.~Sham Ultrasound Procedure: Sliding the ultrasound probe on the patient's back with the machine in the freeze position.~Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.~Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle~Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space~Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space"
11356547|NCT03792191|BG002|Baseline|Total|Total of all reporting groups
11356548|NCT03792191|FG000|Participant Flow|Ultrasonography|"Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.~Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.~Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle~Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space~Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space"
11356549|NCT03792191|FG001|Participant Flow|Palpation|"Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.~Sham Ultrasound Procedure: Sliding the ultrasound probe on the patient's back with the machine in the freeze position.~Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.~Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle~Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space~Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space"
11356550|NCT03792191|OG000|Outcome|Ultrasonography|"Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.~Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.~Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle~Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space~Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space"
11356551|NCT03792191|OG001|Outcome|Palpation|"Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.~Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.~Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.~Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle~Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space~Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space"
11356552|NCT03792191|EG000|Reported Event|Ultrasonography|"Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.~Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.~Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle~Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space~Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space"
11356553|NCT03792191|EG001|Reported Event|Palpation|"Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.~Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.~Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.~Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle~Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space~Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space"
11356554|NCT03791489|BG000|Baseline|Active Treatment|ClariFix: The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
11356555|NCT03791489|FG000|Participant Flow|Active Treatment|ClariFix: The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
11356556|NCT03791489|OG000|Outcome|Active Treatment|ClariFix: The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
11356557|NCT03791489|EG000|Reported Event|Active Treatment|ClariFix: The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
11356558|NCT03790865|BG000|Baseline|Low-Dose Livoletide|"Daily subcutaneous injection of ~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.~Livoletide: Daily subcutaneous injection"
11356559|NCT03790865|BG001|Baseline|High-Dose Livoletide|"Daily subcutaneous injection of ~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.~Livoletide: Daily subcutaneous injection"
11356560|NCT03790865|BG002|Baseline|Placebo|"Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.~Placebo: Daily subcutaneous injection"
11356561|NCT03790865|BG003|Baseline|Total|Total of all reporting groups
11232944|NCT02423109|BG000|Baseline|Overall Study|All subjects were wore both fanfilcon A and enfilcon A toric lenses as either the first or second intervention.
11356562|NCT03790865|FG000|Participant Flow|Low-Dose Livoletide|"Daily subcutaneous injection of ~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.~Livoletide: Daily subcutaneous injection"
11356563|NCT03790865|FG001|Participant Flow|High-Dose Livoletide|"Daily subcutaneous injection of ~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.~Livoletide: Daily subcutaneous injection"
11356564|NCT03790865|FG002|Participant Flow|Placebo|"Daily subcutaneous injection of 0.9% sodium chloride for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.~Placebo: Daily subcutaneous injection"
11356565|NCT03790865|OG000|Outcome|Low-Dose Livoletide|"Daily subcutaneous injection of ~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.~Livoletide: Daily subcutaneous injection"
11356566|NCT03790865|OG001|Outcome|High-Dose Livoletide|"Daily subcutaneous injection of ~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.~Livoletide: Daily subcutaneous injection"
11356567|NCT03790865|OG002|Outcome|Placebo|"Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.~Placebo: Daily subcutaneous injection"
11356568|NCT03790865|EG000|Reported Event|Low-Dose Livoletide|"Daily subcutaneous injection of ~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.~Livoletide: Daily subcutaneous injection"
11356569|NCT03790865|EG001|Reported Event|High-Dose Livoletide|"Daily subcutaneous injection of ~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.~Livoletide: Daily subcutaneous injection"
11356570|NCT03790865|EG002|Reported Event|Placebo|"Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.~Placebo: Daily subcutaneous injection"
11356571|NCT03784300|BG000|Baseline|50 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.~50 mg PTI-125: PTI-125 50 mg Oral Solution"
11356572|NCT03784300|BG001|Baseline|50 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.~50 mg PTI-125: PTI-125 50 mg Oral Solution"
11356573|NCT03784300|BG002|Baseline|100 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.~100 mg PTI-125: PTI-125 100 mg Oral Solution"
11356574|NCT03784300|BG003|Baseline|100 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.~100 mg PTI-125: PTI-125 100 mg Oral Solution"
11356575|NCT03784300|BG004|Baseline|200 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.~200 mg PTI-125: PTI-125 200 mg Oral Solution"
11356576|NCT03784300|BG005|Baseline|200 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.~200 mg PTI-125: PTI-125 200 mg Oral Solution"
11356577|NCT03784300|BG006|Baseline|Total|Total of all reporting groups
11356578|NCT03784300|FG000|Participant Flow|50 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.~50 mg PTI-125: PTI-125 50 mg Oral Solution"
11356579|NCT03784300|FG001|Participant Flow|50 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.~50 mg PTI-125: PTI-125 50 mg Oral Solution"
11356580|NCT03784300|FG002|Participant Flow|100 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.~100 mg PTI-125: PTI-125 100 mg Oral Solution"
11356581|NCT03784300|FG003|Participant Flow|100 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.~100 mg PTI-125: PTI-125 100 mg Oral Solution"
11356582|NCT03784300|FG004|Participant Flow|200 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.~200 mg PTI-125: PTI-125 200 mg Oral Solution"
11356583|NCT03784300|FG005|Participant Flow|200 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.~200 mg PTI-125: PTI-125 200 mg Oral Solution"
11356584|NCT03784300|OG000|Outcome|50 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.~50 mg PTI-125: PTI-125 50 mg Oral Solution"
11356585|NCT03784300|OG001|Outcome|50 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.~50 mg PTI-125: PTI-125 50 mg Oral Solution"
11356586|NCT03784300|OG002|Outcome|100 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.~100 mg PTI-125: PTI-125 100 mg Oral Solution"
11356587|NCT03784300|OG003|Outcome|100 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.~100 mg PTI-125: PTI-125 100 mg Oral Solution"
11356588|NCT03784300|OG004|Outcome|200 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.~200 mg PTI-125: PTI-125 200 mg Oral Solution"
11356589|NCT03784300|OG005|Outcome|200 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.~200 mg PTI-125: PTI-125 200 mg Oral Solution"
11356590|NCT03784300|EG000|Reported Event|50 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.~50 mg PTI-125: PTI-125 50 mg Oral Solution"
11356591|NCT03784300|EG001|Reported Event|50 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.~50 mg PTI-125: PTI-125 50 mg Oral Solution"
11356592|NCT03784300|EG002|Reported Event|100 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.~100 mg PTI-125: PTI-125 100 mg Oral Solution"
11356593|NCT03784300|EG003|Reported Event|100 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.~100 mg PTI-125: PTI-125 100 mg Oral Solution"
11356594|NCT03784300|EG004|Reported Event|200 mg PTI-125|"Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.~200 mg PTI-125: PTI-125 200 mg Oral Solution"
11356595|NCT03784300|EG005|Reported Event|200 mg PTI-125 Placebo|"Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.~200 mg PTI-125: PTI-125 200 mg Oral Solution"
11356596|NCT03790878|BG000|Baseline|Mindful Breathing|"Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.~Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress"
10888021|NCT00504309|FG004|Participant Flow|1g P-OM3, Then Placebo, Then 4g P-OM3|1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
11174184|NCT02020031|FG000|Participant Flow|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
11356597|NCT03790878|BG001|Baseline|Habituation|"Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.~Habituation: An exposure procedure that reduces emotional distress through habituation"
11174185|NCT02020031|FG001|Participant Flow|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
11356598|NCT03790878|BG002|Baseline|Control|"Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.~Control: No emotion regulation intervention, placebo"
11174186|NCT02020031|OG000|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
11174187|NCT02020031|OG001|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
11169948|NCT01994395|BG001|Baseline|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
11169949|NCT01994395|BG002|Baseline|Total|Total of all reporting groups
11356599|NCT03790878|BG003|Baseline|Total|Total of all reporting groups
10851318|NCT00305773|FG000|Participant Flow|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
11089863|NCT01525628|BG001|Baseline|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
11089864|NCT01525628|BG002|Baseline|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
11089865|NCT01525628|BG003|Baseline|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
11089866|NCT01525628|BG004|Baseline|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
11089867|NCT01525628|BG005|Baseline|Total|Total of all reporting groups
11089868|NCT01525628|FG000|Participant Flow|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
11092194|NCT01537835|EG001|Reported Event|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
10851319|NCT00305773|FG001|Participant Flow|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
11232945|NCT02423109|FG000|Participant Flow|Randomized for Fanfilcon A Lens First, Then Enfilcon A Lens|"Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.~fanfilcon A: toric contact lens enfilcon A: toric contact lens"
11232946|NCT02423109|FG001|Participant Flow|Randomized for Enfilcon A Lens First, Then Fanfilcon A Lens|"Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.~fanfilcon A: toric contact lens enfilcon A: toric contact lens"
10851320|NCT00305773|OG000|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
10851321|NCT00305773|OG001|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
11232947|NCT02423109|OG000|Outcome|Fanfilcon A|"All participants who wore fanfilcon A lens pair randomly assigned as first or second pair.~fanfilcon A: contact lens"
10888022|NCT00504309|FG005|Participant Flow|Placebo, Then 1g P-OM3, Then 4g P-OM3|Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks
11232948|NCT02423109|OG001|Outcome|Enfilcon A|"All participants who wore enfilcon A lens pair randomly assigned as first or second pair.~enfilcon A: contact lens"
11232949|NCT02423109|OG000|Outcome|Overall Study - Dispense|"Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.~fanfilcon A: contact lens~enfilcon A: contact lens"
11089869|NCT01525628|FG001|Participant Flow|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
10888023|NCT00504309|OG000|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
10888024|NCT00504309|OG001|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
10888025|NCT00504309|OG002|Outcome|Placebo|4 g/d corn oil placebo
10888026|NCT00504309|OG000|Outcome|4g P-OM3|4 g Prescription Omega-3 acid ethyl esters (P-OM3)
10888027|NCT00504309|OG001|Outcome|1g P-OM3|1 g Prescription Omega-3 acid ethyl esters (P-OM3)
10888028|NCT00504309|OG002|Outcome|Placebo|Corn Oil Placebo
10888029|NCT00504309|OG002|Outcome|Placebo|4 g/d corn Oil Placebo
10888030|NCT00504309|EG000|Reported Event|4g P-OM3|4 g Prescription Omega-3 acid ethyl esters (P-OM3)
10888031|NCT00504309|EG001|Reported Event|1g P-OM3|1 g Prescription Omega-3 acid ethyl esters (P-OM3)
10888032|NCT00504309|EG002|Reported Event|Placebo|Corn oil placebo
10851322|NCT00305773|EG000|Reported Event|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
11089870|NCT01525628|FG002|Participant Flow|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
11089871|NCT01525628|FG003|Participant Flow|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
11169950|NCT01994395|FG000|Participant Flow|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
11169951|NCT01994395|FG001|Participant Flow|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
11356600|NCT03790878|FG000|Participant Flow|Mindful Breathing|"Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.~Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress"
11356601|NCT03790878|FG001|Participant Flow|Habituation|"Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.~Habituation: An exposure procedure that reduces emotional distress through habituation"
11356602|NCT03790878|FG002|Participant Flow|Control|"Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.~Control: No emotion regulation intervention, placebo"
11356603|NCT03790878|OG000|Outcome|Mindful Breathing|"Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.~Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress"
11356604|NCT03790878|OG001|Outcome|Habituation|"Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.~Habituation: An exposure procedure that reduces emotional distress through habituation"
11356605|NCT03790878|OG002|Outcome|Control|"Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.~Control: No emotion regulation intervention, placebo"
11356606|NCT03790878|EG000|Reported Event|Mindful Breathing|"Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.~Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress"
11356607|NCT03790878|EG001|Reported Event|Habituation|"Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.~Habituation: An exposure procedure that reduces emotional distress through habituation"
11356608|NCT03790878|EG002|Reported Event|Control|"Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.~Control: No emotion regulation intervention, placebo"
11356609|NCT03789474|BG000|Baseline|Group A|No intervention was done ,served as a control group.
11356610|NCT03789474|BG001|Baseline|Group B|"Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.~HUNTLEIGH FLOWTRON ACS900"
11356611|NCT03789474|BG002|Baseline|Total|Total of all reporting groups
11356612|NCT03789474|FG000|Participant Flow|Group A|No intervention was done ,served as a control group.
11356613|NCT03789474|FG001|Participant Flow|Group B|"Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.~HUNTLEIGH FLOWTRON ACS900"
11356614|NCT03789474|OG000|Outcome|Group A|No intervention was done ,served as a control group.
11356615|NCT03789474|OG001|Outcome|Group B|"Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.~HUNTLEIGH FLOWTRON ACS900"
11356616|NCT03789474|EG000|Reported Event|Group 1|In Group 1 - The PPC was placed on operating table, next to patients calves during the procedure.
11356617|NCT03789474|EG001|Reported Event|Group 2|In Group 2 - The PPC was placed over calves and inflated during induction of General Anaesthesia and maintenance.
11356618|NCT03789175|BG000|Baseline|Nicotinamide Riboside (NR) in Li-Fraumeni Syndrome|Nicotinamide riboside (NR) to be initiated at week 0 at dose of 250 mg twice a day. At Week 1, NR will be titrated to 500 mg twice a day. At Week 6, NR will be titrated to 750 mg twice a day. At Week 7, NR will be titrated to 1000 mg twice a day or as tolerated until end of week 12. At week 12, if participant responds to primary endpoint, participant will washout of NR at week 18 then restart NR at week 24 until week 30. If there is not response to NR treatment at week 12, the participant may continue taking NR at a tolerated dose until week 24 and the primary endpoint will be re-measured. If participant has a positive response to NR treatment at week 24, then the participant will washout of NR until week 30, at which time the primary endpoint will be re-measured to ensure return to baseline. If there is no response to continued NR treatment at week 24, the study will be ended.
11357435|NCT03758157|EG000|Reported Event|Temperature Measurement|"Each subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer.~welloStationX: welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.~SureTemp: SureTemp is an oral thermometer to measure human body skin temperature."
11356619|NCT03789175|FG000|Participant Flow|Nicotinamide Riboside (NR) in Li-Fraumeni Syndrome|Nicotinamide riboside (NR) to be initiated at week 0 at dose of 250 mg twice a day. At Week 1, NR will be titrated to 500 mg twice a day. At Week 6, NR will be titrated to 750 mg twice a day. At Week 7, NR will be titrated to 1000 mg twice a day or as tolerated until end of week 12. At week 12, if participant responds to primary endpoint, participant will washout of NR at week 18 then restart NR at week 24 until week 30. If there is not response to NR treatment at week 12, the participant may continue taking NR at a tolerated dose until week 24 and the primary endpoint will be re-measured. If participant has a positive response to NR treatment at week 24, then the participant will washout of NR until week 30, at which time the primary endpoint will be re-measured to ensure return to baseline. If there is no response to continued NR treatment at week 24, the study will be ended.
11356620|NCT03789175|OG000|Outcome|Baseline Phosphocreatine (PCr) Recovery Tc Measurement|All participants prior to initiation of nicotinamide riboside (NR).
11356621|NCT03789175|OG001|Outcome|Nicotinamide Riboside (NR) in Li-Fraumeni Syndrome|Nicotinamide riboside (NR) to be initiated at week 0 at dose of 250 mg twice a day. At Week 1, NR will be titrated to 500 mg twice a day. At Week 6, NR will be titrated to 750 mg twice a day. At Week 7, NR will be titrated to 1000 mg twice a day or as tolerated until end of week 12. At week 12, if participant responds to primary endpoint, participant will washout of NR at week 18 then restart NR at week 24 until week 30. If there is not response to NR treatment at week 12, the participant may continue taking NR at a tolerated dose until week 24 and the primary endpoint will be re-measured. If participant has a positive response to NR treatment at week 24, then the participant will washout of NR until week 30, at which time the primary endpoint will be re-measured to ensure return to baseline. If there is no response to continued NR treatment at week 24, the study will be ended.
11356622|NCT03789175|OG000|Outcome|Baseline CPET Exercise Endurance Time|All participants prior to initiation of nicotinamide riboside (NR).
11356623|NCT03789175|EG000|Reported Event|Nicotinamide Riboside (NR) in Li-Fraumeni Syndrome|Nicotinamide riboside (NR) to be initiated at week 0 at dose of 250 mg twice a day. At Week 1, NR will be titrated to 500 mg twice a day. At Week 6, NR will be titrated to 750 mg twice a day. At Week 7, NR will be titrated to 1000 mg twice a day or as tolerated until end of week 12. At week 12, if participant responds to primary endpoint, participant will washout of NR at week 18 then restart NR at week 24 until week 30. If there is not response to NR treatment at week 12, the participant may continue taking NR at a tolerated dose until week 24 and the primary endpoint will be re-measured. If participant has a positive response to NR treatment at week 24, then the participant will washout of NR until week 30, at which time the primary endpoint will be re-measured to ensure return to baseline. If there is no response to continued NR treatment at week 24, the study will be ended.
11356624|NCT03787615|BG000|Baseline|The sipIT Tools|"The wrist-worn sensors used to detect a drinking event (FitBit Versa with custom algorithm), an H2OPal connected water bottle and fluid consumption monitoring mobile applications.~sipIT tools: Just in time drinking detection tools to promote increase fluid consumption"
11356625|NCT03787615|FG000|Participant Flow|The sipIT Tools|"The wrist-worn sensors used to detect a drinking event (FitBit Versa with custom algorithm), an H2OPal connected water bottle and fluid consumption monitoring mobile applications.~sipIT tools: Just in time drinking detection tools to promote increase fluid consumption"
11356626|NCT03787615|OG000|Outcome|The sipIT Tools|"The wrist-worn sensors used to detect a drinking event (FitBit Versa with custom algorithm), an H2OPal connected water bottle and fluid consumption monitoring mobile applications.~sipIT tools: Just in time drinking detection tools to promote increase fluid consumption"
11356627|NCT03787615|OG000|Outcome|sipIT Group Completers @ 3 Months|Participants who completed 3-month follow-up
11356628|NCT03787615|EG000|Reported Event|The sipIT Tools|"The wrist-worn sensors used to detect a drinking event (FitBit Versa with custom algorithm), an H2OPal connected water bottle and fluid consumption monitoring mobile applications.~sipIT tools: Just in time drinking detection tools to promote increase fluid consumption"
11356629|NCT03786718|BG000|Baseline|Intervention|"Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.~Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability."
11356630|NCT03786718|FG000|Participant Flow|Intervention|"Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.~Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability."
11356631|NCT03786718|OG000|Outcome|Intervention|"Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.~Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability."
11356632|NCT03786718|OG000|Outcome|Intervention|"Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.~Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy level appropriate educational resources, and contains secure-messaging capability."
11356633|NCT03786718|EG000|Reported Event|Intervention|"Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.~Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability."
11169952|NCT01994395|OG000|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
11356634|NCT03784963|BG000|Baseline|Primary Prevention Intervention|"In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.~Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily"
11356635|NCT03784963|BG001|Baseline|Primary Prevention Non-Intervention|"In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.~Placebo: Standard of care"
11356636|NCT03784963|BG002|Baseline|Secondary Prevention Intervention|"In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.~Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily"
11356637|NCT03784963|BG003|Baseline|Secondary Prevention Non-Intervention|"In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.~Placebo: Standard of care"
11356638|NCT03784963|BG004|Baseline|Total|Total of all reporting groups
11356639|NCT03784963|FG000|Participant Flow|Primary Prevention Intervention|"In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.~Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily"
11356640|NCT03784963|FG001|Participant Flow|Primary Prevention Non-Intervention|"In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.~Placebo: Standard of care"
11356641|NCT03784963|FG002|Participant Flow|Secondary Prevention Intervention|"In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.~Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily"
11356642|NCT03784963|FG003|Participant Flow|Secondary Prevention Non-Intervention|"In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.~Placebo: Standard of care"
11356643|NCT03784963|OG000|Outcome|Primary Prevention Intervention|"In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.~Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily"
11356644|NCT03784963|OG001|Outcome|Primary Prevention Non-Intervention|"In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.~Placebo: Standard of care"
11356645|NCT03784963|OG002|Outcome|Secondary Prevention Intervention|"In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.~Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily"
11356646|NCT03784963|OG003|Outcome|Secondary Prevention Non-Intervention|"In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.~Placebo: Standard of care"
11356647|NCT03784963|EG000|Reported Event|Primary Prevention Intervention|"In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.~Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily"
11356648|NCT03784963|EG001|Reported Event|Primary Prevention Non-Intervention|"In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.~Placebo: Standard of care"
11356649|NCT03784963|EG002|Reported Event|Secondary Prevention Intervention|"In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.~Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily"
11356650|NCT03784963|EG003|Reported Event|Secondary Prevention Non-Intervention|"In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.~Placebo: Standard of care"
11356651|NCT03771274|BG000|Baseline|Tecnis ZLB00 & Symfony IOL|"The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.~Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye."
11356652|NCT03771274|FG000|Participant Flow|Tecnis ZLB00 & Symfony IOL|"The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.~Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye."
11356653|NCT03771274|OG000|Outcome|Tecnis ZLB00 & Symfony IOL|"The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.~Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye."
11356654|NCT03771274|EG000|Reported Event|Tecnis ZLB00 & Symfony IOL|"The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.~Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye."
11356655|NCT03787472|BG000|Baseline|Total|All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.
11356656|NCT03787472|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
11356657|NCT03787472|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
11169953|NCT01994395|OG001|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
11174188|NCT02020031|EG000|Reported Event|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
11356658|NCT03787472|OG000|Outcome|Test|Subjects that wore the Test lens in either the first or second period of the study.
11169954|NCT01994395|EG000|Reported Event|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
11356659|NCT03787472|OG001|Outcome|Control|Subjects that wore the Control lens in either the first or second period of the study.
11356660|NCT03787472|EG000|Reported Event|Test|Subjects that wore the Test lens in either the first or second period of the study.
11356661|NCT03787472|EG001|Reported Event|Control|Subjects that wore the Control lens in either the first or second period of the study.
11356662|NCT03787212|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into the study prior to early study termination.
11356663|NCT03787212|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the MiBo ThermoFlo as Test in their left eye and then received the Bruder Moist Heat Single Eye Compress as Control in their right eye.
11356664|NCT03787212|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Bruder Moist Heat Single Eye Compress as Control in their left eye and then received the MiBo ThermoFlo as Test in their right eye
11356665|NCT03787212|OG000|Outcome|Test|Subjects that recieved the Test treatment during any point in this study
11356666|NCT03787212|OG001|Outcome|Control|Subjects that recieved the Control treatment at any point during this study.
11356667|NCT03787212|EG000|Reported Event|Test|Subjects that recieved the Test treatment during any point in this study
11356668|NCT03787212|EG001|Reported Event|Control|Subjects that recieved the Control treatment at any point during the study.
11356669|NCT03784001|BG000|Baseline|Gratitude + No Expectations (GNE)|"Participants will type online lists of up to five items they are grateful for, every two days for 13 days.~Gratitude Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items."
11356670|NCT03784001|BG001|Baseline|Gratitude + Expectation (GE)|"Participants will type online lists of up to five items they are grateful for, every two days for 13 days. They will also be told a benefit of gratitude each time they write an online gratitude list.~Gratitude + Expectations Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items. Participants will have a statement at the top of their Google form about the benefits of gratitude. Examples of these statements are: Practicing gratitude may increase social connectedness and Cultivating gratitude was shown to improve school satisfaction in a UK sample of students."
11356671|NCT03784001|BG002|Baseline|Events Control|"Participants will type online lists of up to five events from their day, every two day for 13 days.~Events Control Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a list of up to five items about events from their day."
11356672|NCT03784001|BG003|Baseline|Total|Total of all reporting groups
11356673|NCT03784001|FG000|Participant Flow|Gratitude + No Expectations (GNE)|"Participants will type online lists of up to five items they are grateful for, every two days for 13 days.~Gratitude Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items."
11356674|NCT03784001|FG001|Participant Flow|Gratitude + Expectation (GE)|"Participants will type online lists of up to five items they are grateful for, every two days for 13 days. They will also be told a benefit of gratitude each time they write an online gratitude list.~Gratitude + Expectations Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items. Participants will have a statement at the top of their Google form about the benefits of gratitude. Examples of these statements are: Practicing gratitude may increase social connectedness and Cultivating gratitude was shown to improve school satisfaction in a UK sample of students."
11356675|NCT03784001|FG002|Participant Flow|Events Control|"Participants will type online lists of up to five events from their day, every two day for 13 days.~Events Control Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a list of up to five items about events from their day."
11356676|NCT03784001|OG000|Outcome|Gratitude + No Expectations (GNE)|"Participants will type online lists of up to five items they are grateful for, every two days for 13 days.~Gratitude Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items."
11356677|NCT03784001|OG001|Outcome|Gratitude + Expectation (GE)|"Participants will type online lists of up to five items they are grateful for, every two days for 13 days. They will also be told a benefit of gratitude each time they write an online gratitude list.~Gratitude + Expectations Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items. Participants will have a statement at the top of their Google form about the benefits of gratitude. Examples of these statements are: Practicing gratitude may increase social connectedness and Cultivating gratitude was shown to improve school satisfaction in a UK sample of students."
11356678|NCT03784001|OG002|Outcome|Events Control|"Participants will type online lists of up to five events from their day, every two day for 13 days.~Events Control Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a list of up to five items about events from their day."
11356679|NCT03784001|EG000|Reported Event|Gratitude + No Expectations (GNE)|"Participants will type online lists of up to five items they are grateful for, every two days for 13 days.~Gratitude Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items."
11356680|NCT03784001|EG001|Reported Event|Gratitude + Expectation (GE)|"Participants will type online lists of up to five items they are grateful for, every two days for 13 days. They will also be told a benefit of gratitude each time they write an online gratitude list.~Gratitude + Expectations Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items. Participants will have a statement at the top of their Google form about the benefits of gratitude. Examples of these statements are: Practicing gratitude may increase social connectedness and Cultivating gratitude was shown to improve school satisfaction in a UK sample of students."
11356681|NCT03784001|EG002|Reported Event|Events Control|"Participants will type online lists of up to five events from their day, every two day for 13 days.~Events Control Intervention: Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a list of up to five items about events from their day."
11356682|NCT03783702|BG000|Baseline|Experimental Group|"st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours~nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics~rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics"
11356683|NCT03783702|BG001|Baseline|Control Group|"st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours~nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics"
11356684|NCT03783702|BG002|Baseline|Total|Total of all reporting groups
11356685|NCT03783702|FG000|Participant Flow|Experimental Group|"st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours~nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics~rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics"
11356686|NCT03783702|FG001|Participant Flow|Control Group|"st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours~nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics"
11356687|NCT03783702|OG000|Outcome|Experimental Group|"st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours~nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics~rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics"
11356688|NCT03783702|OG001|Outcome|Control Group|"st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours~nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics"
11356689|NCT03783702|EG000|Reported Event|Experimental Group|"st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours~nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics~rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics"
11356690|NCT03783702|EG001|Reported Event|Control Group|"st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours~nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics"
11356691|NCT03781479|BG000|Baseline|Amifampridine Phosphate - Placebo|"Each patient participated in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate was achieved for 7 days. After this phase, half of the subjects were randomized to receive amifampridine in Period 1 and then crossed over to receive placebo in Period 2. Each randomized treatment period was 14 days in duration.~Dosing was up to 80 mg per day and frequency was between 3-4 times per day. Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate."
11356692|NCT03781479|BG001|Baseline|Placebo - Amifampridine Phosphate|"Each patient participated in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate was achieved for 7 days. After this phase, half of the subjects were randomized to receive placebo in Period 1 and then crossed over to receive amifampridine in Period 2. Each randomized treatment period was 14 days in duration.~Dosing was up to 80 mg per day and frequency was between 3-4 times per day. Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.~Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet."
11356693|NCT03781479|BG002|Baseline|Not Randomized|Patients receiving amifampridine during the open-label run-in period but were not randomized to receive treatment.
11356694|NCT03781479|BG003|Baseline|Total|Total of all reporting groups
11356695|NCT03781479|FG000|Participant Flow|Amifampridine Phosphate - Placebo|"Each patient participated in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate was achieved for 7 days. After this phase, half of the subjects were randomized to receive amifampridine in Period 1 and then crossed over to receive placebo in Period 2. Each randomized treatment period was 14 days in duration.~Dosing was up to 80 mg per day and frequency was between 3-4 times per day.~Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate."
11357436|NCT03757988|BG000|Baseline|Single Arm Experimental Walking Group|This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
11169955|NCT01994395|EG001|Reported Event|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
11169956|NCT01994486|BG000|Baseline|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
11356696|NCT03781479|FG001|Participant Flow|Placebo - Amifampridine Phosphate|"Each patient participated in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate was achieved for 7 days. After this phase, half of the subjects were randomized to receive placebo in Period 1 and then crossed over to receive amifampridine in Period 2. Each randomized treatment period was 14 days in duration.~Dosing was up to 80 mg per day and frequency was between 3-4 times per day.~Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.~Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet."
11356697|NCT03781479|FG002|Participant Flow|Not Randomized|Patients receiving amifampridine during the open-label run-in period but were not randomized to receive treatment.
11356698|NCT03781479|OG000|Outcome|Amifampridine Phosphate|"Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects were randomized to receive amifampridine in Period 1 and then crossed over to receive placebo in Period 2 and the other were randomized to receive placebo in Period 1 and then crossed over to receive amifampridine in Period 2.~Each randomized treatment period is 14 days in duration.~Dosing was up to 80 mg per day and frequency was between 3-4 times per day.~Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.~The Amifampridine study arm includes all patients in the FAS population who received Amifampridine during the treatment period, regardless of which Period the treatment was administered."
11356699|NCT03781479|OG001|Outcome|Placebo|"Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects were randomized to receive amifampridine in Period 1 and then crossed over to receive placebo in Period 2 and the other were randomized to receive placebo in Period 1 and then crossed over to receive amifampridine in Period 2.~Each randomized treatment period is 14 days in duration.~Dosing was up to 80 mg per day and frequency was between 3-4 times per day.~Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.~The Placebo study arm includes all patients in the FAS population who received Placebo during the treatment period, regardless of which Period the treatment was administered."
11356700|NCT03781479|EG000|Reported Event|Amifampridine|Treatment administered to the patient at the time of onset of the AE.
11356701|NCT03781479|EG001|Reported Event|Placebo|Treatment administered to the patient at the time of onset of the AE.
11356702|NCT03781037|BG000|Baseline|GIVE Module|The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.
11356703|NCT03781037|FG000|Participant Flow|Give Module|All participants were assigned to the Give Module, consisting of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.
11356704|NCT03781037|OG000|Outcome|Give Module|All participants were assigned to the Give Module, consisting of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.
11356705|NCT03781037|OG000|Outcome|GIVE Module|The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.
11356706|NCT03781037|EG000|Reported Event|Give Module|All participants were assigned to the Give Module, consisting of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.
11356707|NCT03784079|BG000|Baseline|Part 1: GSK3640254 10 mg|Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356708|NCT03784079|BG001|Baseline|Part 1: GSK3640254 200 mg|Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11169957|NCT01994486|FG000|Participant Flow|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.~In addition, sparse PK samples will be collected at week 2 and week 10."
11169958|NCT01994486|OG000|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
11169959|NCT01994486|OG000|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
11169960|NCT01994486|OG000|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.~In addition, sparse PK samples will be collected at week 2 and week 10."
11169961|NCT01994486|EG000|Reported Event|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
11169962|NCT01994538|BG000|Baseline|Longer (14 Day) Duration Antimicrobial Treatment|"14 days of ciprofloxacin or trimethoprim/sulfamethoxazole~Longer therapy duration: 14 days of antimicrobial treatment"
11169963|NCT01994538|BG001|Baseline|Shorter (7 Day) Duration Antimicrobial Treatment|"7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo~Shorter therapy duration: 7 days of antimicrobial treatment"
11169964|NCT01994538|BG002|Baseline|Total|Total of all reporting groups
11169965|NCT01994538|FG000|Participant Flow|Longer (14 Day) Duration Antimicrobial Treatment|"14 days of ciprofloxacin or trimethoprim/sulfamethoxazole~Longer therapy duration: 14 days of antimicrobial treatment"
11169966|NCT01994538|FG001|Participant Flow|Shorter (7 Day) Duration Antimicrobial Treatment|"7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo~Shorter therapy duration: 7 days of antimicrobial treatment"
11169967|NCT01994538|OG000|Outcome|Longer (14 Day) Duration Antimicrobial Treatment|"14 days of ciprofloxacin or trimethoprim/sulfamethoxazole~Longer therapy duration: 14 days of antimicrobial treatment"
11169968|NCT01994538|OG001|Outcome|Shorter (7 Day) Duration Antimicrobial Treatment|"7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo~Shorter therapy duration: 7 days of antimicrobial treatment"
11169969|NCT01994538|EG000|Reported Event|Longer (14 Day) Duration Antimicrobial Treatment|"14 days of ciprofloxacin or trimethoprim/sulfamethoxazole~Longer therapy duration: 14 days of antimicrobial treatment"
11169970|NCT01994538|EG001|Reported Event|Shorter (7 Day) Duration Antimicrobial Treatment|"7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo~Shorter therapy duration: 7 days of antimicrobial treatment"
11169971|NCT01994590|BG000|Baseline|All Patients|Dovitinib combined with abiraterone and prednisone
11169972|NCT01994590|FG000|Participant Flow|All Patients|Dovitinib combined with abiraterone and prednisone
11169973|NCT01994590|OG000|Outcome|All Patients|Dovitinib combined with abiraterone and prednisone
11169974|NCT01994590|EG000|Reported Event|All Patients|Dovitinib combined with abiraterone and prednisone
11169975|NCT01994629|BG000|Baseline|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
11169976|NCT01994629|BG001|Baseline|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
11169977|NCT01994629|BG002|Baseline|Total|Total of all reporting groups
11169978|NCT01994629|FG000|Participant Flow|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-cross reactive material (CRM) vaccine.
11169979|NCT01994629|FG001|Participant Flow|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-tetanus toxoid (TT) vaccine.
11169980|NCT01994629|OG000|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
11169981|NCT01994629|OG001|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
11169982|NCT01994629|EG000|Reported Event|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
11169983|NCT01994629|EG001|Reported Event|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
11169984|NCT01994720|BG000|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
11169985|NCT01994720|BG001|Baseline|ASA 100 mg|ASA 100 mg once daily (OD)
10888033|NCT00504348|BG000|Baseline|Prospective Investigation Group|"Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.~Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg."
11169986|NCT01994720|BG002|Baseline|Total|Total of all reporting groups
11356709|NCT03784079|BG002|Baseline|Part 1: Placebo|Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356710|NCT03784079|BG003|Baseline|Part 2: GSK3640254 40 mg|Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356711|NCT03784079|BG004|Baseline|Part 2: GSK3640254 80 mg|Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356712|NCT03784079|BG005|Baseline|Part 2: GSK3640254 140 mg|Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356713|NCT03784079|BG006|Baseline|Part 2: Placebo|Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356714|NCT03784079|BG007|Baseline|Total|Total of all reporting groups
11089872|NCT01525628|FG004|Participant Flow|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
11169987|NCT01994720|FG000|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
11356715|NCT03784079|FG000|Participant Flow|Part 1: GSK3640254 10 mg|Participants received GSK3640254 10 milligram (mg), capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356716|NCT03784079|FG001|Participant Flow|Part 1: GSK3640254 200 mg|Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356717|NCT03784079|FG002|Participant Flow|Part 1: Placebo|Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356718|NCT03784079|FG003|Participant Flow|Part 2: GSK3640254 40 mg|Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356719|NCT03784079|FG004|Participant Flow|Part 2: GSK3640254 80 mg|Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356720|NCT03784079|FG005|Participant Flow|Part 2: GSK3640254 140 mg|Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356721|NCT03784079|FG006|Participant Flow|Part 2: Placebo|Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356722|NCT03784079|OG000|Outcome|Part 1: GSK3640254 10 mg|Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356723|NCT03784079|OG001|Outcome|Part 1: GSK3640254 200 mg|Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356724|NCT03784079|OG002|Outcome|Part 1: Placebo|Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356725|NCT03784079|OG000|Outcome|Part 2: GSK3640254 40 mg|Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356726|NCT03784079|OG001|Outcome|Part 2: GSK3640254 80 mg|Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356727|NCT03784079|OG002|Outcome|Part 2: GSK3640254 140 mg|Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356728|NCT03784079|OG003|Outcome|Part 2: Placebo|Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356729|NCT03784079|OG000|Outcome|Part 1: GSK3640254 10 mg|Participants received GSK3640254 10 milligram (mg), capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356730|NCT03784079|OG002|Outcome|Part 2: GSK3640254 40 mg|Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356731|NCT03784079|OG003|Outcome|Part 2: GSK3640254 80 mg|Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356732|NCT03784079|OG004|Outcome|Part 2: GSK3640254 140 mg|Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356733|NCT03784079|OG000|Outcome|GSK3640254 10 mg to 200 mg|In Part 1, participants received GSK3640254 10 mg, 200 mg, capsules, orally for 10 days and in Part 2, participants received GSK3640254 40 mg, 80 mg, 140 mg, capsules, orally for 7 days.
11356734|NCT03784079|EG000|Reported Event|Part 1: GSK3640254 10 mg|Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356735|NCT03784079|EG001|Reported Event|Part 1: GSK3640254 200 mg|Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356736|NCT03784079|EG002|Reported Event|Part 1: Placebo|Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
11356737|NCT03784079|EG003|Reported Event|Part 2: GSK3640254 40 mg|Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356738|NCT03784079|EG004|Reported Event|Part 2: GSK3640254 80 mg|Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356739|NCT03784079|EG005|Reported Event|Part 2: GSK3640254 140 mg|Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356740|NCT03784079|EG006|Reported Event|Part 2: Placebo|Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
11356741|NCT03783039|BG000|Baseline|SURGICEL Powder|SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)
11169988|NCT01994720|FG001|Participant Flow|ASA 100 mg|ASA 100 mg once daily (OD)
11169989|NCT01994720|OG000|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
11169990|NCT01994720|OG001|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
11169991|NCT01994720|EG000|Reported Event|ASA 100mg|ASA 100 mg once daily (OD)
11169992|NCT01994720|EG001|Reported Event|Ticagrelor 90mg|Ticagrelor 90 mg twice daily (BD)
11169993|NCT01994746|BG000|Baseline|All Study Participants|At one visit, a nasal glucagon (NG) dose of 3 mg. At another visit, 1 mg intramuscular (IM) glucagon The order of the visits were randomized.
11169994|NCT01994746|FG000|Participant Flow|NG 1st/IM Glucagon 2nd|At the first visit, 3 milligrams (mg) of nasal glucagon (NG). At the second visit, 1 mg of intramuscular (IM) glucagon.
11169995|NCT01994746|FG001|Participant Flow|IM Glucagon 1st/NG 2nd|At the first visit, 1 mg of IM glucagon. At the second visit, 3 mg of NG glucagon.
11169996|NCT01994746|OG000|Outcome|Nasal Glucagon (NG)|At one visit, 3 mg of NG.
11169997|NCT01994746|OG001|Outcome|Intramuscular (IM) Glucagon|At a separate visit, 1 mg of IM glucagon.
11169998|NCT01994746|EG000|Reported Event|Nasal Glucagon (NG)|At one visit, 3 mg of NG.
11169999|NCT01994746|EG001|Reported Event|Intramuscular (IM) Glucagon|At a separate visit, 1 mg of IM glucagon.
11170000|NCT01994785|BG000|Baseline|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170001|NCT01994785|BG001|Baseline|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170002|NCT01994785|BG002|Baseline|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170003|NCT01994785|BG003|Baseline|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170004|NCT01994785|BG004|Baseline|Total|Total of all reporting groups
11174189|NCT02020031|EG001|Reported Event|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
11170005|NCT01994785|FG000|Participant Flow|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170006|NCT01994785|FG001|Participant Flow|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170007|NCT01994785|FG002|Participant Flow|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170008|NCT01994785|FG003|Participant Flow|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170009|NCT01994785|OG000|Outcome|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170010|NCT01994785|OG001|Outcome|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11356742|NCT03783039|BG001|Baseline|SURGICEL Original|Absorbable Hemostat (Oxidized Regenerated Cellulose)
11356743|NCT03783039|BG002|Baseline|Total|Total of all reporting groups
11170011|NCT01994785|OG002|Outcome|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170012|NCT01994785|OG003|Outcome|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170013|NCT01994785|EG000|Reported Event|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170014|NCT01994785|EG001|Reported Event|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170015|NCT01994785|EG002|Reported Event|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11170016|NCT01994785|EG003|Reported Event|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
11356744|NCT03783039|FG000|Participant Flow|SURGICEL Powder|SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)
11356745|NCT03783039|FG001|Participant Flow|SURGICEL Original|Absorbable Hemostat (Oxidized Regenerated Cellulose)
11356746|NCT03783039|OG000|Outcome|SURGICEL Powder|SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)
11356747|NCT03783039|OG001|Outcome|SURGICEL Original|Absorbable Hemostat (Oxidized Regenerated Cellulose)
11356748|NCT03783039|EG000|Reported Event|SURGICEL Powder|SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)
11356749|NCT03783039|EG001|Reported Event|SURGICEL Original|Absorbable Hemostat (Oxidized Regenerated Cellulose)
11356750|NCT03783130|BG000|Baseline|Group 1: Trimer 4571 (100 mcg) IM With Alum|"Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356751|NCT03783130|BG001|Baseline|Group 2: Trimer 4571 (100 mcg) SC With Alum|"Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356752|NCT03783130|BG002|Baseline|Group 3: Trimer 4571 (500 mcg) IM With Alum|"Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356753|NCT03783130|BG003|Baseline|Group 4: Trimer 4571 (500 mcg) SC With Alum|"Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356754|NCT03783130|BG004|Baseline|Total|Total of all reporting groups
11356755|NCT03783130|FG000|Participant Flow|Group 1: Trimer 4571 (100 mcg) IM With Alum|"Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356756|NCT03783130|FG001|Participant Flow|Group 2: Trimer 4571 (100 mcg) SC With Alum|"Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356757|NCT03783130|FG002|Participant Flow|Group 3: Trimer 4571 (500 mcg) IM With Alum|"Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356758|NCT03783130|FG003|Participant Flow|Group 4: Trimer 4571 (500 mcg) SC With Alum|"Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356759|NCT03783130|OG000|Outcome|Group 1: Trimer 4571 (100 mcg) IM With Alum|"Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356760|NCT03783130|OG001|Outcome|Group 2: Trimer 4571 (100 mcg) SC With Alum|"Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356761|NCT03783130|OG002|Outcome|Group 3: Trimer 4571 (500 mcg) IM With Alum|"Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356762|NCT03783130|OG003|Outcome|Group 4: Trimer 4571 (500 mcg) SC With Alum|"Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356763|NCT03783130|OG004|Outcome|Overall Incidence Trimer 4571 (100 mcg and 500 mcg)|Trimer 4571 dose groups included adults who received either three doses of 100 mcg or three doses of 500 mcg of Trimer 4571 with 500 mcg of alum field mixed administered intramuscularly (IM), or administered subcutaneously (SC) on Day 0, Week 8, and Week 20
11170017|NCT01994837|BG000|Baseline|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
11232950|NCT02423109|OG001|Outcome|Overall Study - Follow Up|"Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.~fanfilcon A: contact lens~enfilcon A: contact lens"
11170018|NCT01994837|FG000|Participant Flow|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
11356764|NCT03783130|EG000|Reported Event|Group 1: Trimer 4571 (100 mcg) IM With Alum|"Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356765|NCT03783130|EG001|Reported Event|Group 2: Trimer 4571 (100 mcg) SC With Alum|"Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356766|NCT03783130|EG002|Reported Event|Group 3: Trimer 4571 (500 mcg) IM With Alum|"Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356767|NCT03783130|EG003|Reported Event|Group 4: Trimer 4571 (500 mcg) SC With Alum|"Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20~VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.~Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine."
11356768|NCT03776175|BG000|Baseline|Placebo|Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356769|NCT03776175|BG001|Baseline|PF-05221304 15mg + Placebo|Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356770|NCT03776175|BG002|Baseline|PF-06865571 300 mg + Placebo|Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356771|NCT03776175|BG003|Baseline|PF-05221304 15 mg + PF-06865571 300 mg|Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356772|NCT03776175|BG004|Baseline|Total|Total of all reporting groups
11356773|NCT03776175|FG000|Participant Flow|Placebo|Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356774|NCT03776175|FG001|Participant Flow|PF-05221304 15mg + Placebo|Participants were randomized to receive PF-05221304 15 milligram (mg) tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356775|NCT03776175|FG002|Participant Flow|PF-06865571 300 mg + Placebo|Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356776|NCT03776175|FG003|Participant Flow|PF-05221304 15 mg + PF-06865571 300 mg|Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356777|NCT03776175|OG000|Outcome|Placebo|Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356778|NCT03776175|OG001|Outcome|PF-05221304 15mg + Placebo|Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356779|NCT03776175|OG002|Outcome|PF-06865571 300 mg + Placebo|Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356780|NCT03776175|OG003|Outcome|PF-05221304 15 mg + PF-06865571 300 mg|Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356781|NCT03776175|EG000|Reported Event|Placebo|Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356782|NCT03776175|EG001|Reported Event|PF-05221304 15mg + Placebo|Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356783|NCT03776175|EG002|Reported Event|PF-06865571 300 mg + Placebo|Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.
11356784|NCT03776175|EG003|Reported Event|"PF-05221304 |15mg Q12H + |PF-06865571 |300mg Q12H"|Participants were randomized to receive PF-05221304 15 mg tablets and PF-06865571 300 mg tablets, orally, twice daily for 42 days. Participants were followed up to maximum of 35 days after last dose of study drug.
11356785|NCT03771963|BG000|Baseline|Tetravalent Dengue Vaccine (TDV)|TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
11356786|NCT03771963|FG000|Participant Flow|Tetravalent Dengue Vaccine (TDV)|TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
11356787|NCT03771963|OG000|Outcome|Tetravalent Dengue Vaccine (TDV)|TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
11356788|NCT03771963|EG000|Reported Event|Tetravalent Dengue Vaccine (TDV)|TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
11356789|NCT03771352|BG000|Baseline|RxSight RxLAL IOL|"Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)~RxSight RxLAL: The patients will be assessed for 6 months"
11356790|NCT03771352|FG000|Participant Flow|RxSight RxLAL IOL|"Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)~RxSight RxLAL: The patients will be assessed for 6 months"
11356791|NCT03771352|OG000|Outcome|RxSight RxLAL IOL|"Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)~RxSight RxLAL: The patients will be assessed for 6 months"
11356792|NCT03771352|EG000|Reported Event|RxSight RxLAL IOL|"Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)~RxSight RxLAL: The patients will be assessed for 6 months"
11356793|NCT03773796|BG000|Baseline|Treatment Group|"Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11356794|NCT03773796|FG000|Participant Flow|Treatment Group|"Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11356795|NCT03773796|OG000|Outcome|Treatment Group|"Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11356796|NCT03773796|EG000|Reported Event|Treatment Group|"Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11356797|NCT03782233|BG000|Baseline|Deep Neuromuscular Blockade（Group D）|50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
11356798|NCT03782233|BG001|Baseline|Moderate Neuromuscular Blockade (Group M)|33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).
11356799|NCT03782233|BG002|Baseline|Total|Total of all reporting groups
11356800|NCT03782233|FG000|Participant Flow|Deep Neuromuscular Blockade（Group D）|50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
11356801|NCT03782233|FG001|Participant Flow|Moderate Neuromuscular Blockade (Group M)|33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).
11356802|NCT03782233|OG000|Outcome|Deep Neuromuscular Blockade（Group D）|50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
11356803|NCT03782233|OG001|Outcome|Moderate Neuromuscular Blockade (Group M)|33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).
11356804|NCT03782233|OG000|Outcome|Deep Neuromuscular Blockade Group (Group D)|"Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium.~A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).: 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2)."
11356805|NCT03782233|OG001|Outcome|Moderate Neuromuscular Blockade Group (Group M)|"Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive moderate neuromuscular blockade (train-of-four count = 1-2) using moderate dose rocuronium.~A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).: 33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2)."
11356806|NCT03782233|EG000|Reported Event|Deep Neuromuscular Blockade（Group D）|50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
11356807|NCT03782233|EG001|Reported Event|Moderate Neuromuscular Blockade (Group M)|33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).
11232951|NCT02423109|EG000|Reported Event|Fanfilcon A|Participants randomized to wear fanfilcon A either as the first or second lens during the cross over study.
11356808|NCT03781375|BG000|Baseline|Methotrexate + Placebo|Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
11356809|NCT03781375|BG001|Baseline|Methotrexate + Etanercept|Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
11356810|NCT03781375|BG002|Baseline|Total|Total of all reporting groups
11232952|NCT02423109|EG001|Reported Event|Enfilcon A|Participants randomized to wear enfilcon A either as the first or second lens during the cross over study.
11232953|NCT02423122|BG000|Baseline|Neflamapimod (VX-745) Dose 1|"Active Group 1: VX-745 40 mg twice daily~VX-745: Orally-Active Selective P45 MAP Kinase inhibitor"
11232954|NCT02423122|BG001|Baseline|Neflamapimod (VX-745) Dose 2|"Active Group 2: VX-745 125 mg twice daily~VX-745: Orally-Active Selective P45 MAP Kinase inhibitor"
11232955|NCT02423122|BG002|Baseline|Total|Total of all reporting groups
11232956|NCT02423122|FG000|Participant Flow|Neflamapimod (VX-745) Dose 1|"Active Group 1: VX-745 40 mg twice daily~VX-745: Orally-Active Selective P45 MAP Kinase inhibitor"
11232957|NCT02423122|FG001|Participant Flow|Neflamapimod (VX-745) Dose 2|"Active Group 2: VX-745 125 mg twice daily~VX-745: Orally-Active Selective P45 MAP Kinase inhibitor"
11232958|NCT02423122|OG000|Outcome|Neflamapimod (VX-745) Dose 1|"Active Group 1: VX-745 40 mg twice daily~VX-745: Orally-Active Selective P45 MAP Kinase inhibitor"
11232959|NCT02423122|OG001|Outcome|Neflamapimod (VX-745) Dose 2|"Active Group 2: VX-745 125 mg twice daily~VX-745: Orally-Active Selective P45 MAP Kinase inhibitor"
11232960|NCT02423122|EG000|Reported Event|40 mg Dose Group|
11232961|NCT02423122|EG001|Reported Event|125 mg Dose Group|
11232962|NCT02423200|BG000|Baseline|VX-745 Dose Level 1|"Active Group 1: VX-745 dose level 1 twice daily~VX-745: Orally-active P38 MAP kinase alpha-selective inhibitor"
11232963|NCT02423200|BG001|Baseline|VX-745 Dose Level 2|"Active Group 1: VX-745 dose level 2 twice daily~VX-745: Orally-active P38 MAP kinase alpha-selective inhibitor"
11232964|NCT02423200|BG002|Baseline|Total|Total of all reporting groups
11232965|NCT02423200|FG000|Participant Flow|Neflamapimod (VX-745) Dose Level 1|"Active Group 1: VX-745 40 mg twice daily~Neflamapimod (VX-745): Orally-active P38 MAP kinase alpha-selective inhibitor"
11232966|NCT02423200|FG001|Participant Flow|Neflamapimod (VX-745) Dose Level 2|"Active Group 1: VX-745 125 mg twice daily~Neflamapimod (VX-745): Orally-active P38 MAP kinase alpha-selective inhibitor"
11232967|NCT02423200|OG000|Outcome|Overall Study Population|Combined 40 mg and 125 mg subjects; N=7 with baseline and Day 42 results
11232968|NCT02423200|OG000|Outcome|Neflamapimod (VX-745) Dose Level 1|"Active Group 1: VX-745 40 mg twice daily~Neflamapimod (VX-745): Orally-active P38 MAP kinase alpha-selective inhibitor"
11232969|NCT02423200|OG001|Outcome|Neflamapimod (VX-745) Dose Level 2|"Active Group 1: VX-745 125 mg twice daily~Neflamapimod (VX-745): Orally-active P38 MAP kinase alpha-selective inhibitor"
11232970|NCT02423200|OG000|Outcome|Overall Study Population|Combined 40 mg and 125 mg subjects
11232971|NCT02423200|EG000|Reported Event|Overall Study Population|Combined 40 mg and 125 mg subjects. As there was only one subject in the 125 mg dose group (see Pre-Assignment Details), and the blood concentration levels in this subject was similar to that in 125 mg dose group, this subjects data was combined with the 40 mg dose group in the adverse event analysis.
11232972|NCT02423291|BG000|Baseline|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.~Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
11232973|NCT02423291|FG000|Participant Flow|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.~Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
11232974|NCT02423291|OG000|Outcome|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.~Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
11233993|NCT02431676|EG000|Reported Event|Self-Directed|"In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.~Self-control weight loss"
11356811|NCT03781375|FG000|Participant Flow|Methotrexate + Placebo|Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
11356812|NCT03781375|FG001|Participant Flow|Methotrexate + Etanercept|Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
11356813|NCT03781375|OG000|Outcome|Methotrexate + Placebo|Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
11356814|NCT03781375|OG001|Outcome|Methotrexate + Etanercept|Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
11356815|NCT03781375|EG000|Reported Event|Methotrexate + Placebo (Blinded Phase)|Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months.
11356816|NCT03781375|EG001|Reported Event|Methotrexate + Etanercept (Blinded Phase)|Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months.
11356817|NCT03781375|EG002|Reported Event|Methotrexate + Etanercept (Open Label Phase)|After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
11356818|NCT03781336|BG000|Baseline|Mindfulness-based Self-care|"Mindfulness-based self-care (5 weeks)~Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions."
11356819|NCT03781336|BG001|Baseline|Life as Usual Control|Life as usual control (5 weeks)
11356820|NCT03781336|BG002|Baseline|Total|Total of all reporting groups
11356821|NCT03781336|FG000|Participant Flow|Mindfulness-based Self-care|"Mindfulness-based self-care (5 weeks)~Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions."
11356822|NCT03781336|FG001|Participant Flow|Life as Usual Control|Life as usual control (5 weeks)
11356823|NCT03781336|OG000|Outcome|Mindfulness-based Self-care|"Mindfulness-based self-care (5 weeks)~Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions."
11356824|NCT03781336|OG001|Outcome|Life as Usual Control|Life as usual control (5 weeks)
11356825|NCT03781336|EG000|Reported Event|Mindfulness-based Self-care|"Mindfulness-based self-care (5 weeks)~Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions."
11356826|NCT03781336|EG001|Reported Event|Life as Usual Control|Life as usual control (5 weeks)
11356827|NCT03780400|BG000|Baseline|OA-PCP|Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
11356828|NCT03780400|FG000|Participant Flow|OA-PCP|Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
11356829|NCT03780400|OG000|Outcome|OA-PCP|Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
11356830|NCT03780400|EG000|Reported Event|OA-PCP|Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
11356831|NCT03779997|BG000|Baseline|Video-based DOT Application|Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.
11356832|NCT03779997|BG001|Baseline|Treatment as Usual (TAU)|Office-based buprenorphine treatment
11356833|NCT03779997|BG002|Baseline|Total|Total of all reporting groups
11356834|NCT03779997|FG000|Participant Flow|Video-based DOT Application|Video-based directly observed therapy (DOT) Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.
11356835|NCT03779997|FG001|Participant Flow|Treatment as Usual (TAU)|Treatment-as-usual administered at office-based buprenorphine treatment clinics.
11356836|NCT03779997|OG000|Outcome|Video-based DOT Application|Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.
11356837|NCT03779997|OG001|Outcome|Treatment as Usual (TAU)|Treatment-as-usual administered at office-based buprenorphine treatment clinics.
11356838|NCT03779997|EG000|Reported Event|Video-based DOT Application|Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.
11356839|NCT03779997|EG001|Reported Event|Treatment as Usual (TAU)|Treatment-as-usual administered at office-based buprenorphine treatment clinics.
11356840|NCT03779503|BG000|Baseline|Overall Study|"Subjects were randomized to wear either midafilcon A 1 day or somofilcon A 1 day for one week of daily wear the cross-over to the other for one week of daily wear during the study.~midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens"
11356841|NCT03779503|FG000|Participant Flow|Midafilcon A Then Somofilcon A|"Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear the cross-over to somofilcon A for one week of daily wear during the study.~midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens"
11233994|NCT02431676|EG001|Reported Event|Coach Directed Behavioral Weight Loss|"The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight~Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals"
11356842|NCT03779503|FG001|Participant Flow|Somofilcon A Then Midafilcon A|"Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear then cross-over to midafilcon A for one week of daily wear during the study.~somofilcon A: somofilcon A 1 day daily disposable contact lens midafilcon A: midafilcon A 1 day daily disposable contact lens"
10851323|NCT00305773|EG001|Reported Event|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
11356843|NCT03779503|OG000|Outcome|Midafilcon A|"Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.~midafilcon A: midafilcon A 1 day daily disposable contact lens"
11356844|NCT03779503|OG001|Outcome|Somofilcon A|"Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.~somofilcon A: somofilcon A 1 day daily disposable contact lens"
11356845|NCT03779503|EG000|Reported Event|Midafilcon A|"Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.~midafilcon A: midafilcon A 1 day daily disposable contact lens"
10851350|NCT00305942|BG000|Baseline|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
11170019|NCT01994837|OG000|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
11170020|NCT01994837|EG000|Reported Event|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
11170021|NCT01994850|BG000|Baseline|Phase I/II|"Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).~Cycle 1:~Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)~Cycles 2-6:~Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg"
10851351|NCT00305942|FG000|Participant Flow|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
11170022|NCT01994850|FG000|Participant Flow|Phase I/II|"Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).~Cycle 1:~Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)~Cycles 2-6:~Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg"
11170023|NCT01994850|OG000|Outcome|Phase I/II|"Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).~Cycle 1:~Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)~Cycles 2-6:~Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg"
11356846|NCT03779503|EG001|Reported Event|Somofilcon A|"Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.~somofilcon A: somofilcon A 1 day daily disposable contact lens"
11170024|NCT01994850|EG000|Reported Event|Phase I/II|"Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).~Cycle 1:~Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)~Cycles 2-6:~Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg"
11170025|NCT01994863|BG000|Baseline|All Subjects|
11356847|NCT03780010|BG000|Baseline|8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin|Dose Level 1: 8 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
11233995|NCT02431676|EG002|Reported Event|Metformin|"This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals~Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months."
11170026|NCT01994863|FG000|Participant Flow|First Coloplast Test Product; Then Standard Care (See Below)|"The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.~Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.~The three Standard Care products were tested in a 1:1:1 randomisation.~Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance~Standard Care: Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
11233996|NCT02431741|BG000|Baseline|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
11233997|NCT02431741|FG000|Participant Flow|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
11233998|NCT02431741|OG000|Outcome|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
11233999|NCT02431741|EG000|Reported Event|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
11356848|NCT03780010|BG001|Baseline|10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin|Dose Level 2: 10 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
10849888|NCT00299130|BG000|Baseline|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11089873|NCT01525628|OG000|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
11234000|NCT02431754|BG000|Baseline|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered QD orally for 8 weeks in one of two treatment periods.~Placebo administered once daily orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11356849|NCT03780010|BG002|Baseline|Total|Total of all reporting groups
11356850|NCT03780010|FG000|Participant Flow|8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin|Dose Level 1: 8 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC
11356851|NCT03780010|FG001|Participant Flow|10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin|Dose Level 2: 10 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC
11356852|NCT03780010|OG000|Outcome|8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin|Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
11356853|NCT03780010|OG001|Outcome|10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin|Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
11356854|NCT03780010|OG000|Outcome|8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin|Dose level 1: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
11356855|NCT03780010|OG000|Outcome|8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin|Dose level 110 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
11234001|NCT02431754|BG001|Baseline|Placebo/Tadalafil|"Placebo administered once daily orally for 8 weeks in one of two treatment periods.~5 mg tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11234002|NCT02431754|BG002|Baseline|Total|Total of all reporting groups
11356856|NCT03780010|EG000|Reported Event|TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 0.00-0.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11089874|NCT01525628|OG001|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
11089875|NCT01525628|OG000|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
11089876|NCT01525628|OG000|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
11089877|NCT01525628|OG002|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
11356857|NCT03780010|EG001|Reported Event|TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 1.00-1.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11356858|NCT03780010|EG002|Reported Event|TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 2.00-2.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11356859|NCT03780010|EG003|Reported Event|TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 3.00-3.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11356860|NCT03780010|EG004|Reported Event|TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 4.00-4.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11356861|NCT03780010|EG005|Reported Event|TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 5.00-5.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11356862|NCT03780010|EG006|Reported Event|TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 6.00-6.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11089878|NCT01525628|OG003|Outcome|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
11089879|NCT01525628|OG004|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
11089880|NCT01525628|EG000|Reported Event|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
11089881|NCT01525628|EG001|Reported Event|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
11089882|NCT01525628|EG002|Reported Event|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
11356863|NCT03780010|EG007|Reported Event|TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 7.0-7.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11356864|NCT03780010|EG008|Reported Event|TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 8.0-8.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11089883|NCT01525628|EG003|Reported Event|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
11089884|NCT01525628|EG004|Reported Event|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
11234003|NCT02431754|FG000|Participant Flow|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~Placebo administered once daily orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11356865|NCT03780010|EG009|Reported Event|TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 9.0-9.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11356866|NCT03780010|EG010|Reported Event|TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin|Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 at a dosage of 10.00 mg/kg at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
11356867|NCT03778190|BG000|Baseline|Magnet|"The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.~Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body."
11356868|NCT03778190|FG000|Participant Flow|Magnet|"The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.~Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body."
10851352|NCT00305942|OG000|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
11234004|NCT02431754|FG001|Participant Flow|Placebo/Tadalafil|"Placebo administered orally QD for 8 weeks in one of two treatment periods.~5 mg tadalafil administered orally QD for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11356869|NCT03778190|OG000|Outcome|Magnet|"The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.~Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body."
11092195|NCT01537835|EG002|Reported Event|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
10851353|NCT00305942|EG000|Reported Event|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
10851354|NCT00306163|BG000|Baseline|Ciclesonide|160 µg, once daily
10851355|NCT00306163|BG001|Baseline|Fluticasone|100 µg, twice daily
10851356|NCT00306163|BG002|Baseline|Total|Total of all reporting groups
11092196|NCT01537887|BG000|Baseline|All Participants|Placebo or 1200 mg LY2484595 administered orally once daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.
10851357|NCT00306163|FG000|Participant Flow|Ciclesonide|160 µg, once daily
10851358|NCT00306163|FG001|Participant Flow|Fluticasone|100 µg, twice daily
10851359|NCT00306163|OG000|Outcome|Ciclesonide|160 µg, once daily
10851360|NCT00306163|OG001|Outcome|Fluticasone|100 µg, twice daily
10851361|NCT00306163|EG000|Reported Event|Ciclesonide|160 µg, once daily
10851362|NCT00306163|EG001|Reported Event|Fluticasone|100 µg, twice daily
10851363|NCT00306189|BG000|Baseline|Denosumab 14 mg Q6M|
10851364|NCT00306189|BG001|Baseline|Denosumab 60 mg Q6M|
10851365|NCT00306189|BG002|Baseline|Denosumab 100 mg Q6M|
10851366|NCT00306189|BG003|Baseline|Placebo|
10851367|NCT00306189|BG004|Baseline|Total|Total of all reporting groups
10851368|NCT00306189|FG000|Participant Flow|Denosumab 14 mg Q6M|
11356870|NCT03778190|EG000|Reported Event|Magnet|"The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.~Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body."
10851369|NCT00306189|FG001|Participant Flow|Denosumab 60 mg Q6M|
10851370|NCT00306189|FG002|Participant Flow|Denosumab 100 mg Q6M|
11092197|NCT01537887|FG000|Participant Flow|Sequence 1|"Placebo or 1200 milligrams (mg) LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.~Sequence 1 (ABC): LY248495, then placebo, then moxifloxacin"
10851371|NCT00306189|FG003|Participant Flow|Placebo|
10851372|NCT00306189|OG000|Outcome|Placebo|
10851373|NCT00306189|OG001|Outcome|Denosumab 14 mg Q6M|
10851374|NCT00306189|OG002|Outcome|Denosumab 60 mg Q6M|
10851375|NCT00306189|OG003|Outcome|Denosumab 100 mg Q6M|
10851376|NCT00306189|EG000|Reported Event|Placebo|
10851377|NCT00306189|EG001|Reported Event|Denosumab 14 mg Q6M|
10851378|NCT00306189|EG002|Reported Event|Denosumab 60 mg Q6M|
10851379|NCT00306189|EG003|Reported Event|Denosumab 100 mg Q6M|
11170027|NCT01994863|FG001|Participant Flow|First Standard Care (See Below); Then Coloplast Test Product|"The subjects are randomised to test Standard care first and thereafter test Coloplast test product.~Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.~The three Standard Care products were tested in a 1:1:1 randomisation.~Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance~Standard Care: Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
11356871|NCT03777059|BG000|Baseline|Placebo|Placebo-matching atogepant tablets orally once daily for 12 weeks.
11170028|NCT01994863|OG000|Outcome|Coloplast Test Product|
11170029|NCT01994863|OG001|Outcome|Standard Care|
11170030|NCT01994863|EG000|Reported Event|Coloplast Test Product|
11170031|NCT01994863|EG001|Reported Event|Standard Care|
11170032|NCT01994876|BG000|Baseline|Overall Study|All the subjects in one group
11170033|NCT01994876|FG000|Participant Flow|First Coloplast Test 1, Then Coloplast Test 2|"The subjects first test their own product to collect a baseline measurement~The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2~Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
11170034|NCT01994876|FG001|Participant Flow|First Coloplast Test 2, Then Coloplast Test 1|"The subjects first test their own product to collect baseline measurements~The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1~Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
11170035|NCT01994876|OG000|Outcome|Coloplast Test 1|Results from subjects testing Coloplast Test 1
11170036|NCT01994876|OG001|Outcome|Coloplast Test 2|Results from subjects testing Coloplast Test 2
11170037|NCT01994876|OG002|Outcome|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
11170038|NCT01994876|EG000|Reported Event|Coloplast Test 1|Results from subjects testing Coloplast Test 1
11170039|NCT01994876|EG001|Reported Event|Coloplast Test 2|Results from subjects testing Coloplast Test 2
11170040|NCT01994876|EG002|Reported Event|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
11170041|NCT01994889|BG000|Baseline|Tafamidis 20 mg|Participants with variant transthyretin cardiomyopathy (TTR-CM) genotype or wild-type TTR-CM genotype received one tafamidis 20 milligram (mg) capsule + 3 placebo capsules (matched to tafamidis) orally once daily for 30 months.
11170042|NCT01994889|BG001|Baseline|Tafamidis 80 mg|Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received tafamidis 80 mg (4 capsules of 20 mg each) orally once daily for 30 months.
11170043|NCT01994889|BG002|Baseline|Placebo|Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.
11170044|NCT01994889|BG003|Baseline|Total|Total of all reporting groups
11170045|NCT01994889|FG000|Participant Flow|Tafamidis 20 mg|Participants with variant transthyretin cardiomyopathy (TTR-CM) genotype or wild-type TTR-CM genotype received one tafamidis 20 milligram (mg) capsule + 3 placebo capsules (matched to tafamidis) orally once daily for 30 months.
11170046|NCT01994889|FG001|Participant Flow|Tafamidis 80 mg|Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received tafamidis 80 mg (4 capsules of 20 mg each) orally once daily for 30 months.
11170047|NCT01994889|FG002|Participant Flow|Placebo|Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.
11170048|NCT01994889|OG000|Outcome|Tafamidis|Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received one tafamidis 20 mg + 3 placebo capsules (matched to tafamidis) or 80 mg (4 capsules of 20 mg each) capsule orally once daily for 30 months.
11170049|NCT01994889|OG001|Outcome|Placebo|Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.
11170050|NCT01994889|EG000|Reported Event|Tafamidis 20 mg|Participants with variant transthyretin cardiomyopathy (TTR-CM) genotype or wild-type TTR-CM genotype received one tafamidis 20 milligram (mg) capsule + 3 placebo capsules (matched to tafamidis) orally once daily for 30 months.
11170051|NCT01994889|EG001|Reported Event|Tafamidis 80 mg|Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received tafamidis 80 mg (4 capsules of 20 mg each) orally once daily for 30 months.
11170052|NCT01994889|EG002|Reported Event|Placebo|Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.
11170053|NCT01994902|BG000|Baseline|Overall Study|The investigation is a cross-over investigation therefore the baseline data is given for the overall study population
11356872|NCT03777059|BG001|Baseline|Atogepant 10 mg|Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11356873|NCT03777059|BG002|Baseline|Atogepant 30 mg|Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11356874|NCT03777059|BG003|Baseline|Atogepant 60 mg|Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11356875|NCT03777059|BG004|Baseline|Total|Total of all reporting groups
11170054|NCT01994902|FG000|Participant Flow|First Coloplast Test Product; Then SenSura Convex Light|"The subjects test:~test period 1: Coloplast test product test period 2: SenSura Convex Light~."
11170055|NCT01994902|FG001|Participant Flow|First SenSura Convex Light; Then Coloplast Test Product|"The subjects test:~test period 1: SenSura Convex Light test period 2: Coloplast test product"
11170056|NCT01994902|OG000|Outcome|Coloplast Test Product|Leakage results obtained while subjects tested the Coloplast test product
11170057|NCT01994902|OG001|Outcome|SenSura Convex Light|The leakage results obtained while subjects were testing SenSura Convex Light
11170058|NCT01994902|EG000|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
11170059|NCT01994902|EG001|Reported Event|SenSura Convex Light|Adverse events reported by subjects testing SenSura Convex Light
11356876|NCT03777059|FG000|Participant Flow|Placebo|Placebo-matching atogepant tablets orally once daily for 12 weeks.
10851380|NCT00306202|BG000|Baseline|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained.
11092198|NCT01537887|FG001|Participant Flow|Sequence 2|"Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.~Sequence 2 (BCA): placebo, then moxifloxacin, then LY2484595"
11170060|NCT01994954|BG000|Baseline|Arm A:Standard Therapy|Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities.
11170061|NCT01994954|BG001|Baseline|Arm B:RHO|"Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits.~Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography.~RHO: Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions."
11170062|NCT01994954|BG002|Baseline|Total|Total of all reporting groups
11170063|NCT01994954|FG000|Participant Flow|Arm A:Standard Therapy|Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities.
11356877|NCT03777059|FG001|Participant Flow|Atogepant 10 mg|Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11356878|NCT03777059|FG002|Participant Flow|Atogepant 30 mg|Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11092199|NCT01537887|FG002|Participant Flow|Sequence 3|"Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.~Sequence 3 (CAB): moxifloxacin, then LY2484595, placebo"
11356879|NCT03777059|FG003|Participant Flow|Atogepant 60 mg|Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11170064|NCT01994954|FG001|Participant Flow|Arm B:RHO|"Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits.~Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography.~RHO: Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions."
11170065|NCT01994954|OG000|Outcome|Arm A:Standard Therapy|Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities.
11170066|NCT01994954|OG001|Outcome|Arm B:RHO|"Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits.~Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography.~RHO: Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions."
11170067|NCT01994954|OG000|Outcome|Arm A: Standard of Care, Pre-Weaning|Growth assessments were documented at each monthly clinic visit while on oxygen. Infants who had at least one assessment were included in the analysis.
10850972|NCT03410992|EG009|Reported Event|Bimekizumab 320 mg Q4W/Q8W Escape (ESS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
11170068|NCT01994954|OG001|Outcome|Arm B: Intervention Arm; Pre-Weaning|Growth assessments were documented at each monthly clinic visit while on oxygen. Infants who had at least one assessment were included in the analysis.
11356880|NCT03777059|OG000|Outcome|Placebo|Placebo-matching atogepant tablets orally once daily for 12 weeks.
11092200|NCT01537887|FG003|Participant Flow|Sequence 4|"Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.~Sequence 4 (CBA): moxifloxacin, then placebo, then LY2484595"
11170069|NCT01994954|OG002|Outcome|Arm A: Standard of Care; Post-Weaning|Growth assessments were documented at the one and six month follow-up visits. Infants who had at least one assessment were included in the analysis.
11170070|NCT01994954|OG003|Outcome|Arm B: Intervention Arm; Post-Weaning|Growth assessments were documented at the one and six month follow-up visits. Infants who had at least one assessment were included in the analysis.
11170071|NCT01994954|OG002|Outcome|Arm A: Standard of Care; Post-Weaning|Growth assessments were documented at the one month and six month post wean follow-up visits. Infants who had at least one assessment in the follow-up period were included in the analysis.
11170072|NCT01994954|OG003|Outcome|Arm B: Intervention Arm; Post-Weaning|Growth assessments were documented at the one month and six month post wean follow-up visits. Infants who had at least one assessment in the follow-up period were included in the analysis.
11170073|NCT01994954|EG000|Reported Event|Arm A:Standard Therapy|Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities.
11170074|NCT01994954|EG001|Reported Event|Arm B:RHO|"Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits.~Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography.~RHO: Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions."
11170075|NCT01994993|BG000|Baseline|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170076|NCT01994993|BG001|Baseline|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170077|NCT01994993|BG002|Baseline|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170078|NCT01994993|BG003|Baseline|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170079|NCT01994993|BG004|Baseline|Group 5|"metronidazole, clindamycin, or piperacillin-tazobactam~metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170080|NCT01994993|BG005|Baseline|Total|Total of all reporting groups
11170081|NCT01994993|FG000|Participant Flow|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11356881|NCT03777059|OG001|Outcome|Atogepant 10 mg|Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11170082|NCT01994993|FG001|Participant Flow|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170083|NCT01994993|FG002|Participant Flow|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170084|NCT01994993|FG003|Participant Flow|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170085|NCT01994993|FG004|Participant Flow|Group 5|"metronidazole, clindamycin, or piperacillin-tazobactam~metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170086|NCT01994993|OG000|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170087|NCT01994993|OG001|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170088|NCT01994993|OG002|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170089|NCT01994993|OG003|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170090|NCT01994993|OG004|Outcome|Group 5|"metronidazole, clindamycin, or piperacillin-tazobactam~metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170091|NCT01994993|EG000|Reported Event|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170092|NCT01994993|EG001|Reported Event|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170093|NCT01994993|EG002|Reported Event|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170094|NCT01994993|EG003|Reported Event|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170095|NCT01994993|EG004|Reported Event|Group 5|"metronidazole, clindamycin, or piperacillin-tazobactam~metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
11170096|NCT01995045|BG000|Baseline|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
11170097|NCT01995045|BG001|Baseline|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
11170098|NCT01995045|BG002|Baseline|Total|Total of all reporting groups
11170099|NCT01995045|FG000|Participant Flow|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
11170100|NCT01995045|FG001|Participant Flow|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
11356882|NCT03777059|OG002|Outcome|Atogepant 30 mg|Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11170101|NCT01995045|OG000|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
11170102|NCT01995045|OG001|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
11356883|NCT03777059|OG003|Outcome|Atogepant 60 mg|Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11170103|NCT01995045|EG000|Reported Event|Bupivicaine & Triamcinolone|"Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide~Triamcinolone: Retrobulbar anesthesia~Bupivicaine Hydrochloride: Retrobulbar anesthesia"
11170104|NCT01995045|EG001|Reported Event|Bupivicaine|"Retrobulbar anesthesia with Bupivicaine Hydrochloride~Bupivicaine Hydrochloride: Retrobulbar anesthesia"
11356884|NCT03777059|EG000|Reported Event|Placebo|Placebo-matching atogepant tablets orally once daily for 12 weeks.
10888034|NCT00504348|FG000|Participant Flow|Prospective Investigation Group|"Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.~Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg."
11170105|NCT01995071|BG000|Baseline|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170106|NCT01995071|BG001|Baseline|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170107|NCT01995071|BG002|Baseline|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170108|NCT01995071|BG003|Baseline|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170109|NCT01995071|BG004|Baseline|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170110|NCT01995071|BG005|Baseline|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170111|NCT01995071|BG006|Baseline|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170112|NCT01995071|BG007|Baseline|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170113|NCT01995071|BG008|Baseline|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170114|NCT01995071|BG009|Baseline|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170115|NCT01995071|BG010|Baseline|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170116|NCT01995071|BG011|Baseline|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170117|NCT01995071|BG012|Baseline|Total|Total of all reporting groups
11356885|NCT03777059|EG001|Reported Event|Atogepant 10 mg|Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11356886|NCT03777059|EG002|Reported Event|Atogepant 30 mg|Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
11092201|NCT01537887|FG004|Participant Flow|Sequence 5|"Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.~Sequence 5 (ACB): LY2484595, then moxifloxacin, then placebo"
11170118|NCT01995071|FG000|Participant Flow|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11356887|NCT03777059|EG003|Reported Event|Atogepant 60 mg|Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
10850973|NCT03410992|EG010|Reported Event|Bimekizumab 320 mg Q4W/Q4W Escape (ESS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
10850974|NCT03138096|BG000|Baseline|Group 1|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
10850975|NCT03138096|BG001|Baseline|Group 2|"(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
11170119|NCT01995071|FG001|Participant Flow|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170120|NCT01995071|FG002|Participant Flow|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170121|NCT01995071|FG003|Participant Flow|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170122|NCT01995071|FG004|Participant Flow|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11356888|NCT03772522|BG000|Baseline|Immediate dk Leadership Intervention|"Participants allocated to the immediate intervention group are assessed for study outcomes immediately before and after the intervention.~Outcomes measured immediately post-intervention are compared with participants who have not received the intervention during the 6 weeks. After the delayed intervention group takes the intervention, the two groups are joined into a single arm.~dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada."
11356889|NCT03772522|BG001|Baseline|Delayed dk Leadership Intervention|"Participants allocated to this arm receive 6 weeks of no intervention. Outcomes are measured immediately before and after the 6 week period. The change in outcomes are compared with participants who have received the intervention during the 6 week period.~This group then receives the same dk Leadership intervention; after this point, the two groups are joined into a single arm for subsequent analyses.~dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada."
11356890|NCT03772522|BG002|Baseline|Total|Total of all reporting groups
11356891|NCT03772522|FG000|Participant Flow|Immediate dk Leadership Intervention|"Participants allocated to the immediate intervention group are assessed for study outcomes immediately before and after the intervention.~Outcomes measured immediately post-intervention are compared with participants who have not received the intervention during the 6 weeks. After the delayed intervention group takes the intervention, the two groups are joined into a single arm.~dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada."
11356892|NCT03772522|FG001|Participant Flow|Delayed dk Leadership Intervention|"Participants allocated to this arm receive 6 weeks of no intervention. Outcomes are measured immediately before and after the 6 week period. The change in outcomes are compared with participants who have received the intervention during the 6 week period.~This group then receives the same dk Leadership intervention; after this point, the two groups are joined into a single arm for subsequent analyses.~dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada."
11170123|NCT01995071|FG005|Participant Flow|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170124|NCT01995071|FG006|Participant Flow|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170125|NCT01995071|FG007|Participant Flow|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170126|NCT01995071|FG008|Participant Flow|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11356893|NCT03772522|OG000|Outcome|Immediate dk Leadership Intervention|"Participants receive the dk Leadership intervention immediately after their baseline interview.~dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada."
11356894|NCT03772522|OG001|Outcome|Delayed dk Leadership Intervention|"Participants allocated to this arm are followed for 6 weeks after enrolment with no intervention; they then receive the dk Leadership intervention.~dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada."
11356895|NCT03772522|OG002|Outcome|Pooled Analysis of Immediate and Delayed Intervention Groups|After both groups had received the dk Leadership intervention, analyses for the immediate and delayed intervention groups were pooled for subsequent analyses. These timepoints include immediately post-intervention, 3-months post-intervention, 6-months post-intervention and 9-months post-intervention.
11356896|NCT03772522|OG002|Outcome|Pooled Analysis of Immediate and Delayed Intervention Groups|After both groups had received the dk Leadership intervention, analyses for the immediate and delayed intervention groups were pooled for subsequent analyses. Analyses were performed immediately post-intervention, 3-months post-intervention, 6-months post-intervention and 9-months post-intervention
11356897|NCT03772522|OG002|Outcome|Pooled Analysis of Immediate and Delayed Intervention Groups|After both groups had received the dk Leadership intervention, analyses for the immediate and delayed intervention groups were pooled for subsequent analyses. Analyses were performed immediately post-intervention, 3-months post-intervention, 6-months post-intervention and 9-months post-intervention.
11356898|NCT03772522|OG000|Outcome|Pooled Analysis of Immediate and Delayed Intervention Groups|Data for the immediate and delayed intervention groups were pooled.
11356899|NCT03772522|EG000|Reported Event|Immediate dk Leadership Intervention|"Participants receive the dk Leadership intervention immediately after their baseline interview.~dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada."
11356900|NCT03772522|EG001|Reported Event|Delayed dk Leadership Intervention|"Participants allocated to this arm are followed for 6 weeks after enrolment with no intervention; they then receive the dk Leadership intervention.~dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada."
11356901|NCT03772327|BG000|Baseline|Routine Counseling + AdhereTech Bottle|"Participants will receive routine medication adherence counseling and be given the AdhereTech smart bottle with reminders.~Adheretech smart bottle: A smart pill bottle that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.~Routine adherence counseling: Participants will be provided with routine adherence counseling"
11356902|NCT03772327|BG001|Baseline|Routine Counseling|"Participants will receive routine medication adherence counseling.~Routine adherence counseling: Participants will be provided with routine adherence counseling"
11356903|NCT03772327|BG002|Baseline|Total|Total of all reporting groups
11356904|NCT03772327|FG000|Participant Flow|Routine Counseling + AdhereTech Bottle|"Participants will receive routine medication adherence counseling and be given the AdhereTech smart bottle with reminders.~Adheretech smart bottle: A smart pill bottle that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.~Routine adherence counseling: Participants will be provided with routine adherence counseling"
11356905|NCT03772327|FG001|Participant Flow|Routine Counseling|"Participants will receive routine medication adherence counseling.~Routine adherence counseling: Participants will be provided with routine adherence counseling"
11356906|NCT03772327|OG000|Outcome|Routine Counseling + AdhereTech Bottle|"Participants will receive routine medication adherence counseling and be given the AdhereTech smart bottle with reminders.~Adheretech smart bottle: A smart pill bottle that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.~Routine adherence counseling: Participants will be provided with routine adherence counseling"
11356907|NCT03772327|OG001|Outcome|Routine Counseling|"Participants will receive routine medication adherence counseling.~Routine adherence counseling: Participants will be provided with routine adherence counseling"
11170127|NCT01995071|FG009|Participant Flow|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170128|NCT01995071|FG010|Participant Flow|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11234005|NCT02431754|OG000|Outcome|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11356908|NCT03772327|EG000|Reported Event|Routine Counseling + AdhereTech Bottle|"Participants will receive routine medication adherence counseling and be given the AdhereTech smart bottle with reminders.~Adheretech smart bottle: A smart pill bottle that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.~Routine adherence counseling: Participants will be provided with routine adherence counseling"
11356909|NCT03772327|EG001|Reported Event|Routine Counseling|"Participants will receive routine medication adherence counseling.~Routine adherence counseling: Participants will be provided with routine adherence counseling"
11356910|NCT03777865|BG000|Baseline|13-Valent Pneumococcal Conjugate (13vPnC) Vaccine|Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
11356911|NCT03777865|FG000|Participant Flow|13-Valent Pneumococcal Conjugate (13vPnC) Vaccine|Participants received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1.
11356912|NCT03777865|OG000|Outcome|13-Valent Pneumococcal Conjugate (13vPnC) Vaccine|Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
11356913|NCT03777865|EG000|Reported Event|13-Valent Pneumococcal Conjugate (13vPnC) Vaccine|Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
11356914|NCT03774576|BG000|Baseline|RO7017773 Alone, Then RO7017773 + Itraconazole|In Period 1, participants received a single dose of RO7017773 alone in a fed state. In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
11356915|NCT03774576|FG000|Participant Flow|RO7017773 Alone, Then RO7017773 + Itraconazole|In Period 1, participants received a single dose of RO7017773 alone in a fed state. In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
11356916|NCT03774576|OG000|Outcome|RO7017773 Alone|In Period 1, participants received a single dose of RO7017773 alone in a fed state.
11356917|NCT03774576|OG001|Outcome|RO7017773 + Itraconazole|In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
11356918|NCT03774576|OG001|Outcome|Itraconazole Alone|In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
11356919|NCT03774576|OG002|Outcome|RO7017773 + Itraconazole|In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
11356920|NCT03774576|EG000|Reported Event|RO7017773 Alone|In Period 1, participants received a single dose of RO7017773 alone in a fed state.
11356921|NCT03774576|EG001|Reported Event|Itraconazole Alone|In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
11356922|NCT03774576|EG002|Reported Event|RO7017773 + Itraconazole|In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
11356923|NCT03776539|BG000|Baseline|Group 1|Mild Renal Impairment eGFR 60 to 89 mL/min/1.73 m^2
11356924|NCT03776539|BG001|Baseline|Group 2|Moderate Renal Impairment eGFR 30 to 59 mL/min/1.73 m^2
11356925|NCT03776539|BG002|Baseline|Group 3|Severe Renal Impairment eGFR <30 mL/min/1.73 m^2, Not Requiring Dialysis
11356926|NCT03776539|BG003|Baseline|Group 4|Healthy Volunteers eGFR >=90 mL/min/1.73 m^2
11356927|NCT03776539|BG004|Baseline|Total|Total of all reporting groups
11356928|NCT03776539|FG000|Participant Flow|Mild Renal Impairment|eGFR 60 to 89 mL/min/1.73 m^2
11356929|NCT03776539|FG001|Participant Flow|Moderate Renal Impairment|eGFR 30 to 59 mL/min/1.73 m^2
11356930|NCT03776539|FG002|Participant Flow|Severe Renal Impairment|eGFR <30 mL/min/1.73 m^2, Not Requiring Dialysis
11356931|NCT03776539|FG003|Participant Flow|Healthy Volunteers|eGFR >=90 mL/min/1.73 m^2
11356932|NCT03776539|OG000|Outcome|Mild Renal Impairment|eGFR 60 to 89 mL/min/1.73 m^2
11356933|NCT03776539|OG001|Outcome|Moderate Renal Impairment|eGFR 30 to 59 mL/min/1.73 m^2
11356934|NCT03776539|OG002|Outcome|Severe Renal Impairment|eGFR <30 mL/min/1.73 m^2, Not Requiring Dialysis
11356935|NCT03776539|OG003|Outcome|Healthy Volunteers|eGFR >=90 mL/min/1.73 m^2
11356936|NCT03776539|EG000|Reported Event|Group 1|Mild Renal Impairment eGFR 60 to 89 mL/min/1.73 m^2
11356937|NCT03776539|EG001|Reported Event|Group 2|Moderate Renal Impairment eGFR 30 to 59 mL/min/1.73 m^2
11356938|NCT03776539|EG002|Reported Event|Group 3|Severe Renal Impairment eGFR <30 mL/min/1.73 m^2, Not Requiring Dialysis
11356939|NCT03776539|EG003|Reported Event|Group 4|Healthy Volunteers eGFR >=90 mL/min/1.73 m^2
11356940|NCT03772041|BG000|Baseline|OPC-61815 Injection 16 mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
11356941|NCT03772041|BG001|Baseline|Tolvaptan Tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
11356942|NCT03772041|BG002|Baseline|Total|Total of all reporting groups
11356943|NCT03772041|FG000|Participant Flow|OPC-61815 Injection 16 mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
11356944|NCT03772041|FG001|Participant Flow|Tolvaptan Tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
11356945|NCT03772041|OG000|Outcome|OPC-61815 Injection 16 mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
11356946|NCT03772041|OG001|Outcome|Tolvaptan Tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
11356947|NCT03772041|EG000|Reported Event|OPC-61815 Injection 16 mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
11356948|NCT03772041|EG001|Reported Event|Tolvaptan Tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
11170129|NCT01995071|FG011|Participant Flow|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170130|NCT01995071|OG000|Outcome|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11356949|NCT03775681|BG000|Baseline|LMA® Gastro™|Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.
11356950|NCT03775681|FG000|Participant Flow|LMA® Gastro™|Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.
11356951|NCT03775681|OG000|Outcome|LMA® Gastro™|Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.
11356952|NCT03775681|EG000|Reported Event|LMA® Gastro™|Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.
11356953|NCT03774823|BG000|Baseline|Freeze Plus|"Subjects in this arm will receive treatment using RF and PEMF~RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment"
11356954|NCT03774823|BG001|Baseline|Ultrasound|"Subjects in this arm will receive treatment using ultrasound~Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area"
11356955|NCT03774823|BG002|Baseline|Total|Total of all reporting groups
11356956|NCT03774823|FG000|Participant Flow|Freeze Plus|"Subjects in this arm will receive treatment using RF and PEMF~RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment"
11356957|NCT03774823|FG001|Participant Flow|Ultrasound|"Subjects in this arm will receive treatment using ultrasound~Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area"
11356958|NCT03774823|OG000|Outcome|Freeze Plus|"Subjects in this arm will receive treatment using RF and PEMF~RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment"
11356959|NCT03774823|OG001|Outcome|Ultrasound|"Subjects in this arm will receive treatment using ultrasound~Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area"
11356960|NCT03774823|EG000|Reported Event|Freeze Plus|"Subjects in this arm will receive treatment using RF and PEMF~RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment"
11356961|NCT03774823|EG001|Reported Event|Ultrasound|"Subjects in this arm will receive treatment using ultrasound~Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area"
11356962|NCT03774745|BG000|Baseline|Progesterone|"Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).~Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.~Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.~micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2."
11356963|NCT03774745|BG001|Baseline|Placebo Oral Capsule|"Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.~Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.~Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2."
11356964|NCT03774745|BG002|Baseline|Total|Total of all reporting groups
11356965|NCT03774745|FG000|Participant Flow|Progesterone|"Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).~Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.~Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.~micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2."
11356966|NCT03774745|FG001|Participant Flow|Placebo Oral Capsule|"Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.~Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.~Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2."
11356967|NCT03774745|OG000|Outcome|Progesterone|"Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).~Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.~Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.~micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2."
11170131|NCT01995071|OG001|Outcome|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170132|NCT01995071|OG002|Outcome|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170133|NCT01995071|OG003|Outcome|Arm 4 Non-cirrhotic + Arm 5 Compensated Cirrhotic|ABT-493 Dose D or Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11234006|NCT02431754|OG001|Outcome|Placebo/Tadalafil|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11170134|NCT01995071|OG004|Outcome|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170135|NCT01995071|OG005|Outcome|Arm 7 Non-cirrhotic + Arm 10 Compensated Cirrhotic|ABT-530 Dose B or Dose E (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170136|NCT01995071|OG006|Outcome|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170137|NCT01995071|OG007|Outcome|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170138|NCT01995071|OG008|Outcome|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170139|NCT01995071|OG009|Outcome|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170140|NCT01995071|OG003|Outcome|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170141|NCT01995071|OG004|Outcome|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170142|NCT01995071|OG005|Outcome|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170143|NCT01995071|OG006|Outcome|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170144|NCT01995071|OG007|Outcome|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170145|NCT01995071|OG008|Outcome|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11356968|NCT03774745|OG001|Outcome|Placebo Oral Capsule|"Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.~Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.~Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2."
11356969|NCT03774745|EG000|Reported Event|Progesterone|"Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).~Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.~Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.~micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2."
11356970|NCT03774745|EG001|Reported Event|Placebo Oral Capsule|"Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.~Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.~Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2."
11356971|NCT03774433|BG000|Baseline|Laddr|"All participants in the study will be invited to use Laddr, described in the intervention section.~Laddr: Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
11356972|NCT03774433|FG000|Participant Flow|Laddr|"All participants in the study will be invited to use Laddr, described in the intervention section.~Laddr: Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
11356973|NCT03774433|OG000|Outcome|Laddr|"All participants in the study will be invited to use Laddr, described in the intervention section.~Laddr: Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
11356974|NCT03774433|EG000|Reported Event|Laddr|"All participants in the study will be invited to use Laddr, described in the intervention section.~Laddr: Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
11357437|NCT03757988|FG000|Participant Flow|Single Arm Experimental Walking Group|"This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.~Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it."
11170146|NCT01995071|OG009|Outcome|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170147|NCT01995071|OG010|Outcome|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170148|NCT01995071|OG011|Outcome|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170149|NCT01995071|EG000|Reported Event|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170150|NCT01995071|EG001|Reported Event|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170151|NCT01995071|EG002|Reported Event|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170152|NCT01995071|EG003|Reported Event|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170153|NCT01995071|EG004|Reported Event|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170154|NCT01995071|EG005|Reported Event|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170155|NCT01995071|EG006|Reported Event|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170156|NCT01995071|EG007|Reported Event|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170157|NCT01995071|EG008|Reported Event|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170158|NCT01995071|EG009|Reported Event|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11170159|NCT01995071|EG010|Reported Event|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
11174190|NCT02020135|BG000|Baseline|PSMA ADC Chemotherapy-experienced|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
11174191|NCT02020135|BG001|Baseline|PSMA ADC Chemotherapy-naive|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
11174192|NCT02020135|BG002|Baseline|Total|Total of all reporting groups
11174193|NCT02020135|FG000|Participant Flow|Arm 1: PSMA ADC|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
11174194|NCT02020135|OG000|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
11234007|NCT02431754|OG000|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11170160|NCT01995123|BG000|Baseline|Behavioral Activation Therapy|"Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.~Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.~Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period."
11170161|NCT01995123|BG001|Baseline|Health and Smoking Education|"Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.~Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.~Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period."
11170162|NCT01995123|BG002|Baseline|Total|Total of all reporting groups
11170163|NCT01995123|FG000|Participant Flow|Behavioral Activation Therapy|"Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.~Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.~Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period."
11234008|NCT02431754|OG001|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11356975|NCT03771560|BG000|Baseline|Folinic Acid Open-label|"In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose.~folinic acid: subject will take folinic acid daily for 12 weeks"
11232975|NCT02423291|EG000|Reported Event|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.~Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
11356976|NCT03771560|FG000|Participant Flow|Folinic Acid Open-label|"In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose.~folinic acid: subject will take folinic acid daily for 12 weeks"
11174195|NCT02020135|OG001|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
11170164|NCT01995123|FG001|Participant Flow|Health and Smoking Education|"Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.~Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.~Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period."
11232976|NCT02423317|BG000|Baseline|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
11232977|NCT02423317|BG001|Baseline|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
11356977|NCT03771560|OG000|Outcome|Folinic Acid Open-label|"In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose.~folinic acid: subject will take folinic acid daily for 12 weeks"
11232978|NCT02423317|BG002|Baseline|Total|Total of all reporting groups
11232979|NCT02423317|FG000|Participant Flow|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
11232980|NCT02423317|FG001|Participant Flow|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
11170165|NCT01995123|OG000|Outcome|Behavioral Activation Therapy|"Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.~Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.~Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period."
11356978|NCT03771560|EG000|Reported Event|Folinic Acid Open-label|"In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose.~folinic acid: subject will take folinic acid daily for 12 weeks"
11356979|NCT03770091|BG000|Baseline|Foam and Compression Wrap|"Patients will use Theraworx foam and a compression wrap~Theraworx: Theraworx foam applied to skin and/or compression wrap"
11356980|NCT03770091|BG001|Baseline|Placebo Foam and Compression Wrap|"Patients will use placebo foam and a compression wrap~Placebo: Placebo foam"
11170166|NCT01995123|OG001|Outcome|Health and Smoking Education|"Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.~Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.~Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period."
11170167|NCT01995123|EG000|Reported Event|Behavioral Activation Therapy|"Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.~Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.~Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period."
11170168|NCT01995123|EG001|Reported Event|Health and Smoking Education|"Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.~Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.~Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period."
11170169|NCT01995136|BG000|Baseline|TRAVATAN Z|Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
11170170|NCT01995136|FG000|Participant Flow|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
11170171|NCT01995136|OG000|Outcome|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
11170172|NCT01995136|EG000|Reported Event|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
11170173|NCT01995201|BG000|Baseline|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
11170174|NCT01995201|BG001|Baseline|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
11170175|NCT01995201|BG002|Baseline|Total|Total of all reporting groups
11170176|NCT01995201|FG000|Participant Flow|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
11170177|NCT01995201|FG001|Participant Flow|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
11170178|NCT01995201|FG002|Participant Flow|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170179|NCT01995201|FG003|Participant Flow|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170180|NCT01995201|FG004|Participant Flow|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170181|NCT01995201|FG005|Participant Flow|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator's judgement.
11170182|NCT01995201|FG006|Participant Flow|Phase 2 Arm D: Non Responders|Non responders, safety population.
11170183|NCT01995201|OG000|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
11170184|NCT01995201|OG001|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
11170185|NCT01995201|OG000|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170186|NCT01995201|OG001|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11356981|NCT03770091|BG002|Baseline|Foam Alone|"Patients will use Theraworx foam without compression wrap~Theraworx: Theraworx foam applied to skin and/or compression wrap"
11356982|NCT03770091|BG003|Baseline|Total|Total of all reporting groups
11170187|NCT01995201|OG000|Outcome|Phase 2 Arm A1 - Monotherapy - qw|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy from Week 24 to Week 48.
11170188|NCT01995201|OG001|Outcome|Phase 2 Arm A1- Combination Therapy - qw|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170189|NCT01995201|OG002|Outcome|Phase 2 Arm A2 - Monotherapy - q2w|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks monotherapy from Week 24 to Week 48.
11170190|NCT01995201|OG003|Outcome|Phase 2 Arm A2 - Combination Therapy - q2w|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170191|NCT01995201|OG002|Outcome|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170192|NCT01995201|OG003|Outcome|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator's judgement.
11170193|NCT01995201|OG004|Outcome|Phase 2 Arm D: Non Responders|Patients who didn't achieve any therapeutic response up to week 24 and were discontinued from the study.
11170194|NCT01995201|OG002|Outcome|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. Participants who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator's judgement.
11170195|NCT01995201|EG000|Reported Event|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
11170196|NCT01995201|EG001|Reported Event|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
11170197|NCT01995201|EG002|Reported Event|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170198|NCT01995201|EG003|Reported Event|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170199|NCT01995201|EG004|Reported Event|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
11170200|NCT01995201|EG005|Reported Event|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator's judgement.
11170201|NCT01995201|EG006|Reported Event|Phase 2 Arm D: Non Responders|Patients who didn't achieve any therapeutic response up to week 24 and were discontinued from the study.
11356983|NCT03770091|FG000|Participant Flow|Foam and Compression Wrap|"Patients will use Theraworx foam and a compression wrap~Theraworx: Theraworx foam applied to skin and/or compression wrap"
10850976|NCT03138096|BG002|Baseline|Group 3|"(group 3) will be exposed to 75 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
10850977|NCT03138096|BG003|Baseline|Group 4|"Infectivity control group~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
11170202|NCT01995266|BG000|Baseline|All Subjects|Oral dose of daclatasvir (DCV) 60 mg once daily (QD) and asunaprevir (ASV) 100 mg twice daily (BID) was administered for 24 weeks. Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11356984|NCT03770091|FG001|Participant Flow|Placebo Foam and Compression Wrap|"Patients will use placebo foam and a compression wrap~Placebo: Placebo foam"
10850978|NCT03138096|BG004|Baseline|Group 5|"Infectivity control group~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
10850979|NCT03138096|BG005|Baseline|Total|Total of all reporting groups
10850980|NCT03138096|FG000|Participant Flow|Group 1 - Five Pb(PfCS@UIS4)-Infected Mosquitoes|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
10850981|NCT03138096|FG001|Participant Flow|Group 2 - 25 Pb(PfCS@UIS4)-Infected Mosquito Bites|"(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
11170203|NCT01995266|FG000|Participant Flow|All Subjects|Oral dose of daclatasvir (DCV) 60 mg once daily (QD) and asunaprevir (ASV) 100 mg twice daily (BID) was administered for 24 weeks. Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11356985|NCT03770091|FG002|Participant Flow|Foam Alone|"Patients will use Theraworx foam without compression wrap~Theraworx: Theraworx foam applied to skin and/or compression wrap"
11356986|NCT03770091|OG000|Outcome|Foam and Compression Wrap|"Patients will use Theraworx foam and a compression wrap~Theraworx: Theraworx foam applied to skin and/or compression wrap"
11356987|NCT03770091|OG001|Outcome|Placebo Foam and Compression Wrap|"Patients will use placebo foam and a compression wrap~Placebo: Placebo foam"
11356988|NCT03770091|OG002|Outcome|Foam Alone|"Patients will use Theraworx foam without compression wrap~Theraworx: Theraworx foam applied to skin and/or compression wrap"
11170204|NCT01995266|OG000|Outcome|All Subjects|Oral dose of daclatasvir (DCV) 60 mg once daily (QD) and asunaprevir (ASV) 100 mg twice daily (BID) was administered for 24 weeks. Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
10850982|NCT03138096|FG002|Participant Flow|Group 3 -25 Pb(PfCS@UIS4)-Infected Mosquito Bites|"(group 3) will be exposed to 75 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
10850983|NCT03138096|FG003|Participant Flow|Group 4 - Infectivity Control Group (Phase 1)|"Infectivity control group (Phase 1)~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
11170205|NCT01995266|EG000|Reported Event|All Subjects|Oral dose of daclatasvir (DCV) 60 mg once daily (QD) and asunaprevir (ASV) 100 mg twice daily (BID) was administered for 24 weeks. Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11170206|NCT01995357|BG000|Baseline|All Subjects|Baseline data is summarized for all subjects
11174196|NCT02020135|EG000|Reported Event|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
10850984|NCT03138096|FG004|Participant Flow|Group 5 - Infectivity Control Group (Phase 2)|"Infectivity control group of Phase 2~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
10850985|NCT03138096|OG000|Outcome|Group 1|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
11234009|NCT02431754|EG000|Reported Event|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11234010|NCT02431754|EG001|Reported Event|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
11234011|NCT02431793|BG000|Baseline|Usual Care|Employ the standard of care, no intervention
10850986|NCT03138096|OG001|Outcome|Group 2|"(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
11356989|NCT03770091|EG000|Reported Event|Foam and Compression Wrap|"Patients will use Theraworx foam and a compression wrap~Theraworx: Theraworx foam applied to skin and/or compression wrap"
11356990|NCT03770091|EG001|Reported Event|Placebo Foam and Compression Wrap|"Patients will use placebo foam and a compression wrap~Placebo: Placebo foam"
11356991|NCT03770091|EG002|Reported Event|Foam Alone|"Patients will use Theraworx foam without compression wrap~Theraworx: Theraworx foam applied to skin and/or compression wrap"
10850987|NCT03138096|OG002|Outcome|Group 3|"(group 3) will be exposed to 75 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
11356992|NCT03769896|BG000|Baseline|Treatment Group|"Nabilone 0.25 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11356993|NCT03769896|BG001|Baseline|Placebo Group|"Placebo (corn starch)~Placebo: capsule, corn starch, daily basis"
11356994|NCT03769896|BG002|Baseline|Total|Total of all reporting groups
11356995|NCT03769896|FG000|Participant Flow|Treatment Group|"Nabilone 0.25 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11356996|NCT03769896|FG001|Participant Flow|Placebo Group|"Placebo (corn starch)~Placebo: capsule, corn starch, daily basis"
11356997|NCT03769896|OG000|Outcome|Treatment Group|"Nabilone 0.25 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11356998|NCT03769896|OG001|Outcome|Placebo Group|"Placebo (corn starch)~Placebo: capsule, corn starch, daily basis"
11356999|NCT03769896|EG000|Reported Event|Treatment Group (Open-label Phase)|"Nabilone 0.25 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11357000|NCT03769896|EG001|Reported Event|Treatment Group (Double-blind Phase)|"Nabilone 0.25 mg~Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis"
11357001|NCT03769896|EG002|Reported Event|Placebo Group (Double-blind Phase)|"Placebo (corn starch)~Placebo: capsule, corn starch, daily basis"
11357002|NCT03769207|BG000|Baseline|Ambulatory ECG|Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
11357003|NCT03769207|FG000|Participant Flow|Ambulatory ECG|Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
11357004|NCT03769207|OG000|Outcome|Ambulatory ECG|Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
11357005|NCT03769207|EG000|Reported Event|Ambulatory ECG|Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
11357006|NCT03768856|BG000|Baseline|Temporally Feathered Radiation Therapy (TFRT)|"Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term feathering.~Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed."
11357007|NCT03768856|FG000|Participant Flow|Temporally Feathered Radiation Therapy (TFRT)|"Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term feathering.~Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed."
11357008|NCT03768856|OG000|Outcome|Temporally Feathered Radiation Therapy (TFRT)|"Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term feathering.~Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed."
11357009|NCT03768856|EG000|Reported Event|Temporally Feathered Radiation Therapy (TFRT)|"Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term feathering.~Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed."
11357010|NCT03768726|BG000|Baseline|Ziprasidone in A1281198 and A1281201|Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
11357011|NCT03768726|BG001|Baseline|Placebo in A1281198 Then Ziprasidone in A1281201|Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight >45 kg) or Week 1 (with body weight <45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
11357012|NCT03768726|BG002|Baseline|Total|Total of all reporting groups
11357438|NCT03757988|OG000|Outcome|Single Arm Experimental Walking Group|This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
11357013|NCT03768726|FG000|Participant Flow|Ziprasidone in A1281198 and A1281201|Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight greater than or equal to (>=) 45 kilogram (kg) had a target total daily dose range of 120-160 milligram per day (mg/day) given in 2 divided doses with food. Participants with body weight less than (<) 45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
11357014|NCT03768726|FG001|Participant Flow|Placebo in A1281198 Then Ziprasidone in A1281201|Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight >45 kg) or Week 1 (with body weight <45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
11357015|NCT03768726|OG000|Outcome|Ziprasidone in A1281198 and A1281201|Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
11357016|NCT03768726|OG001|Outcome|Placebo in A1281198 Then Ziprasidone in A1281201|Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight >45 kg) or Week 1 (with body weight <45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
11357017|NCT03768726|EG000|Reported Event|Ziprasidone in A1281198 and A1281201|Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
11357018|NCT03768726|EG001|Reported Event|Placebo in A1281198 Then Ziprasidone in A1281201|Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight >45 kg) or Week 1 (with body weight <45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
11357019|NCT03768206|BG000|Baseline|PATH|"PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.~Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement~Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement."
11357020|NCT03768206|BG001|Baseline|PATH-12|"PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.~Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement~Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement."
11357021|NCT03768206|BG002|Baseline|Total|Total of all reporting groups
10850988|NCT03138096|OG003|Outcome|Group 4|"Infectivity control group~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
11170207|NCT01995357|FG000|Participant Flow|First Coloplast Teast A; Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
11170208|NCT01995357|FG001|Participant Flow|First Coloplast Test A; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
11170209|NCT01995357|FG002|Participant Flow|First Coloplast Test B; Then Colopast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
11170210|NCT01995357|FG003|Participant Flow|First Coloplast Test B; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
11170211|NCT01995357|FG004|Participant Flow|First Standard Product; Then Coloplast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
11170212|NCT01995357|FG005|Participant Flow|First Standard Product, Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
11170213|NCT01995357|OG000|Outcome|Colostomy ,Test A|
11170214|NCT01995357|OG001|Outcome|Colostomy, Training + Test A|
11170215|NCT01995357|OG002|Outcome|Colostomy, Test B|
11170216|NCT01995357|OG003|Outcome|Colostomy, Training + Test B|
11170217|NCT01995357|OG004|Outcome|Colostomy, Standard Care (SenSura Mio)|
11170218|NCT01995357|OG005|Outcome|Colostomy, Standard Care (SenSura)|
11170219|NCT01995357|OG006|Outcome|Ileostomy, Test A|
11170220|NCT01995357|OG007|Outcome|Ileostomy, Training + Test A|
11170221|NCT01995357|OG008|Outcome|Ileostomy, Test B|
11170222|NCT01995357|OG009|Outcome|Ileostomy, Training + Test B|
11170223|NCT01995357|OG010|Outcome|Ileostomy, Standard Care (SenSura)|
11170224|NCT01995357|EG000|Reported Event|Test A + Training Test A|"Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A.~Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one."
11170225|NCT01995357|EG001|Reported Event|Test B + Training Test B|"Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B.~Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one."
11170226|NCT01995357|EG002|Reported Event|Standard Care|Standard care was used only during part one of the study. i.e. for one period only.
11170227|NCT01995461|BG000|Baseline|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
11170228|NCT01995461|FG000|Participant Flow|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
11170229|NCT01995461|OG000|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
11170230|NCT01995461|EG000|Reported Event|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
11170231|NCT01995487|BG000|Baseline|BioNIR|"The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising:~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent~Delivery System - Rapid Exchange (RX) Coronary System~Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®~Ridaforolimus drug - CAS Registry Number: 572924-54-0~The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent).~BioNIR: drug-eluting stent"
11170232|NCT01995487|BG001|Baseline|Resolute|"The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems:~Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent~Delivery system (Rapid Exchange [RX] Coronary System)~Polymer system~Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area.~Resolute: drug-eluting stent"
11170233|NCT01995487|BG002|Baseline|Total|Total of all reporting groups
11170234|NCT01995487|FG000|Participant Flow|BioNIR|"The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising:~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent~Delivery System - Rapid Exchange (RX) Coronary System~Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®~Ridaforolimus drug - CAS Registry Number: 572924-54-0~The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent).~BioNIR: drug-eluting stent"
11170235|NCT01995487|FG001|Participant Flow|Resolute|"The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems:~Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent~Delivery system (Rapid Exchange [RX] Coronary System)~Polymer system~Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area.~Resolute: drug-eluting stent"
11170236|NCT01995487|OG000|Outcome|BioNIR|"Participants received The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising:~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent~Delivery System - Rapid Exchange (RX) Coronary System~Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®~Ridaforolimus drug - CAS Registry Number: 572924-54-0~The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent)."
11170237|NCT01995487|OG001|Outcome|Resolute|"Participants received The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems:~Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent~Delivery system (Rapid Exchange [RX] Coronary System)~Polymer system~Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area."
11170238|NCT01995487|EG000|Reported Event|BioNIR|"Subjects received The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising:~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent~Delivery System - Rapid Exchange (RX) Coronary System~Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®~Ridaforolimus drug - CAS Registry Number: 572924-54-0~The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent).~BioNIR: drug-eluting stent"
11170239|NCT01995487|EG001|Reported Event|Resolute|"Subjects received The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems:~Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent~Delivery system (Rapid Exchange [RX] Coronary System)~Polymer system~Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area.~Resolute: drug-eluting stent"
11170240|NCT01995513|BG000|Baseline|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
11170241|NCT01995513|FG000|Participant Flow|Enzalutamide 160 mg|Participants received enzalutamide 160 milligram (mg) as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
11170242|NCT01995513|FG001|Participant Flow|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed prostate-specific antigen (PSA) progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
11170243|NCT01995513|FG002|Participant Flow|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
11170244|NCT01995513|OG000|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
11170245|NCT01995513|OG001|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
11170246|NCT01995513|OG000|Outcome|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
11170247|NCT01995513|OG001|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
11232981|NCT02423317|OG000|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
11232982|NCT02423317|OG001|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
11232983|NCT02423317|EG000|Reported Event|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
11232984|NCT02423317|EG001|Reported Event|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
11170248|NCT01995513|OG002|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
11170249|NCT01995513|EG000|Reported Event|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or patient withdrawal, whichever occurs first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
11170250|NCT01995513|EG001|Reported Event|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
10850989|NCT03138096|OG000|Outcome|Group 1 -Five Pb(PfCS@UIS4)-Infected Mosquitoes|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
10850990|NCT03138096|OG001|Outcome|Group 2 - 25 Pb(PfCS@UIS4)-Infected Mosquito Bites|"(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
11232985|NCT02423343|BG000|Baseline|Galunisertib + Nivolumab (Cohort 1) Phase 1b|50 mg Galunisertib administered orally daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given intravenously (IV) every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11170251|NCT01995513|EG002|Reported Event|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
11170252|NCT01995526|BG000|Baseline|Insulin Peglispro|Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
11170253|NCT01995526|FG000|Participant Flow|Insulin Peglispro|Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.
11170254|NCT01995526|OG000|Outcome|Insulin Peglispro|Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
11170255|NCT01995526|EG000|Reported Event|Insulin Peglispro|Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
11170256|NCT01995539|BG000|Baseline|iPro2 Use|All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
11170257|NCT01995539|FG000|Participant Flow|iPro2 Use|All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
11170258|NCT01995539|OG000|Outcome|iPro2 Use|All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
11170259|NCT01995539|EG000|Reported Event|iPro2 Use|All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
11170260|NCT01995552|BG000|Baseline|External Loop Recorder (Single Arm)|"This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder)~After enrollment in the study the following visits are scheduled:~Baseline (day of discharge or one day before discharge after index MI). the main activities were Patient demographics, apply ELR, 12 lead ECG, LVEF etc.~Chronic phase follow-up visit: apply ELR, 12 lead ECG, LVEF etc. 6 and 9 months follow-up: Telephonic health status if patient is not seen.~12-month follow-up visit: In office visit, health status questionnaire~Extended follow-up beyond 12 months: Telephonic health status at the study end (when the last patient completes the 12 months follow up)."
11170261|NCT01995552|FG000|Participant Flow|External Loop Recorder (Single Arm)|"This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder) After enrollment in the study the following visits are scheduled:~Baseline (day of discharge or one day before discharge after index MI). the main activities were Patient demographics, apply ELR, 12 lead ECG, LVEF etc.~Chronic phase follow-up visit: apply ELR, 12 lead ECG, LVEF etc. 6 and 9 months follow-up: Telephonic health status if patient is not seen.~12-month follow-up visit: In office visit, health status questionnaire~Extended follow-up beyond 12 months: Telephonic health status at the study end (when the last patient completes the 12 months follow up)."
10850991|NCT03138096|OG002|Outcome|Group 3 - 75 Pb(PfCS@UIS4)-Infected Mosquito Bites|"(group 3) will be exposed to 75 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
11170262|NCT01995552|OG000|Outcome|External Loop Recorder (Single Arm)|This is a non-randomized study. All the patients will be enrolled will received the ELR system.
11170263|NCT01995552|OG000|Outcome|Acute Phase (With Arrhythmias)|"Patients were classified as with significant arrhythmia when during the ELR monitoring period and mortality was seen during 12 month follow-up."
11170264|NCT01995552|OG001|Outcome|Acute Phase (Without Arrhythmias)|"Patients were classified as without significant arrhythmia when during the ELR monitoring period and mortality was seen during 12 month follow-up."
11170265|NCT01995552|EG000|Reported Event|External Loop Recorder (Single Arm)|For this study, only Deaths and Cardiovascular Related Serious Adverse Events were collected. There were in total 28 deaths and 49 SAEs reported. No system or procedure related SAE were reported
11170266|NCT01995825|BG000|Baseline|Brand Lamotrigine Then Generic Lamotrigine|Crossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods.
11170267|NCT01995825|BG001|Baseline|Generic Lamotrigine Then Brand Lamotrigine|Crossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods.
11170268|NCT01995825|BG002|Baseline|Total|Total of all reporting groups
11170269|NCT01995825|FG000|Participant Flow|Brand Lamotrigine Then Generic Lamotrigine|Crossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods.
11170270|NCT01995825|FG001|Participant Flow|Generic Lamotrigine Then Brand Lamotrigine|Crossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods.
11170271|NCT01995825|OG000|Outcome|Brand Lamotrigine|Brand lamotrigine tablet100mg tablets (1-3 either once or twice a day) for two weeks
10850992|NCT03138096|OG003|Outcome|Group 4 - Infectivity Control Group|"Infectivity control group~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes~No exposure to Pb(PfCS@UIS4)"
11170272|NCT01995825|OG001|Outcome|Generic Lamotrigine|Generic lamotrigine tablet100mg tablets (1-3 either once or twice a day) for two weeks
11170273|NCT01995825|EG000|Reported Event|Brand Lamotrigine|Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks
11170274|NCT01995825|EG001|Reported Event|Generic Lamotrigine|Generic lamotrigine tablet100mg tablets (1-3 either once or twice a day) for two weeks
10850993|NCT03138096|OG000|Outcome|Group 1 -Five Pb(PfCS@UIS4)-Infected Mosquitoes|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~Not exposed to P. falciparum"
10850994|NCT03138096|OG001|Outcome|Group 2 - 25 Pb(PfCS@UIS4)-Infected Mosquito Bites|"(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~Not exposed to P. falciparum"
11170275|NCT01995838|BG000|Baseline|Lemborexant 1 mg|Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
11170276|NCT01995838|BG001|Baseline|Lemborexant 2.5 mg|Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
10850995|NCT03138096|OG003|Outcome|Group 4 - Infectivity Control Group|"Infectivity control group~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
11170277|NCT01995838|BG002|Baseline|Lemborexant 5 mg|Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170278|NCT01995838|BG003|Baseline|Lemborexant 10 mg|Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170279|NCT01995838|BG004|Baseline|Lemborexant 15 mg|Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170280|NCT01995838|BG005|Baseline|Lemborexant 25 mg|Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170281|NCT01995838|BG006|Baseline|Placebo|Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170282|NCT01995838|BG007|Baseline|Total|Total of all reporting groups
11170283|NCT01995838|FG000|Participant Flow|Placebo|Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170284|NCT01995838|FG001|Participant Flow|Lemborexant 1 Milligram (mg)|Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
11170285|NCT01995838|FG002|Participant Flow|Lemborexant 2.5 mg|Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170286|NCT01995838|FG003|Participant Flow|Lemborexant 5 mg|Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170287|NCT01995838|FG004|Participant Flow|Lemborexant 10 mg|Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170288|NCT01995838|FG005|Participant Flow|Lemborexant 15 mg|Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170289|NCT01995838|FG006|Participant Flow|Lemborexant 25 mg|Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170290|NCT01995838|OG000|Outcome|Lemborexant 1 mg|Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
10850996|NCT03138096|OG000|Outcome|Group 1|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~No humoral responses measured"
10850997|NCT03138096|OG001|Outcome|Group 2|"(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~No humoral responses measured"
11170291|NCT01995838|OG001|Outcome|Lemborexant 2.5 mg|Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170292|NCT01995838|OG002|Outcome|Lemborexant 5 mg|Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170293|NCT01995838|OG003|Outcome|Lemborexant 10 mg|Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170294|NCT01995838|OG004|Outcome|Lemborexant 15 mg|Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170295|NCT01995838|OG005|Outcome|Lemborexant 25 mg|Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170296|NCT01995838|OG006|Outcome|Placebo|Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170297|NCT01995838|OG006|Outcome|Placebo|Days 1 to 15: Three E2006-matched placebo tablets were taken orally, 30 minutes before bedtime, each night for 15 consecutive nights. Days 16 to 18: Two E2006-matched placebo tablets were taken for 2 consecutive nights. Days 10 to 30: No study drug, E2006 or placebo, was taken.
11170298|NCT01995838|EG000|Reported Event|Lemborexant 1 mg|Participants received lemborexant 1 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once on Days 16 and 17 in the single-blind placebo run-out phase.
11170299|NCT01995838|EG001|Reported Event|Lemborexant 2.5 mg|Participants received lemborexant 2.5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
10850998|NCT03138096|OG003|Outcome|Group 4|"Infectivity control group~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes~No humoral responses measured"
11170300|NCT01995838|EG002|Reported Event|Lemborexant 5 mg|Participants received lemborexant 5 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170301|NCT01995838|EG003|Reported Event|Lemborexant 10 mg|Participants received lemborexant 10 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170302|NCT01995838|EG004|Reported Event|Lemborexant 15 mg|Participants received lemborexant 15 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170303|NCT01995838|EG005|Reported Event|Lemborexant 25 mg|Participants received lemborexant 25 mg tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170304|NCT01995838|EG006|Reported Event|Placebo|Participants received lemborexant placebo-matching tablets, orally, once daily on Day 1 to Day 15 in the double-blind treatment phase, followed by lemborexant placebo-matching tablets, orally, once daily on Days 16 and 17 in the single-blind placebo run-out phase.
11170305|NCT01996033|BG000|Baseline|Full Cohort|All subjects - this is a single arm study
11170306|NCT01996033|FG000|Participant Flow|Full Cohort|All subjects - this is a single arm study
11170307|NCT01996033|OG000|Outcome|Full Cohort|All subjects - this is a single arm study
11170308|NCT01996033|EG000|Reported Event|Full Cohort|All subjects - this is a single arm study
11170309|NCT01996241|BG000|Baseline|Intervention Village Cluster|All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
11170310|NCT01996241|BG001|Baseline|Control Village Cluster|All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
11170311|NCT01996241|BG002|Baseline|Total|Total of all reporting groups
11170312|NCT01996241|FG000|Participant Flow|Intervention Village Cluster|All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
11170313|NCT01996241|FG001|Participant Flow|Control Village Cluster|All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
11170314|NCT01996241|OG000|Outcome|SC/ST Girls in Intervention Village Cluster|All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
11170315|NCT01996241|OG001|Outcome|SC/ST Girls in Control Village Cluster|All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
11170316|NCT01996241|OG000|Outcome|SC/ST Girls in Intervention Village Cluster|All SC/ST girls in cohort 2 in final year of primary school living in intervention villages
11170317|NCT01996241|OG001|Outcome|SC/ST Girls in Control Village Cluster|All SC/ST girls in cohort 2 in final year of primary school living in control villages
11170318|NCT01996241|EG000|Reported Event|SC/ST Girls in Intervention Village Cluster|All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
11170319|NCT01996241|EG001|Reported Event|SC/ST Girls in Control Village Cluster|All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
11170320|NCT01996254|BG000|Baseline|Group 1 (Treatment Group, Revised Study Design)|Treatment Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received electrical stimulation therapy.
11170321|NCT01996254|BG001|Baseline|Group 2 (Control Group, Revised Study Design)|Control Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received sham stimulation therapy.
11170322|NCT01996254|BG002|Baseline|Total|Total of all reporting groups
11170323|NCT01996254|FG000|Participant Flow|Initial Study Design Subjects|Subjects who were consented and enrolled under the initial design of the study. These subjects are included in the Safety Set.
11170324|NCT01996254|FG001|Participant Flow|Group 1 (Treatment Group, Revised Study Design)|Treatment Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received electrical stimulation therapy.
11170325|NCT01996254|FG002|Participant Flow|Group 2 (Control Group, Revised Study Design)|Control Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received sham stimulation therapy.
11170326|NCT01996254|OG000|Outcome|Group 1 (Treatment Group, Revised Study Design)|Treatment Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received electrical stimulation therapy.
11170327|NCT01996254|OG001|Outcome|Group 2 (Control Group, Revised Study Design)|Control Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received sham stimulation therapy.
11170328|NCT01996254|OG000|Outcome|Initial Study Design Subjects|Subjects who were consented and enrolled under the initial design of the study.
11170329|NCT01996254|OG001|Outcome|Group 1 (Treatment Group, Revised Study Design)|Treatment Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received electrical stimulation therapy.
11170330|NCT01996254|OG002|Outcome|Group 2 (Control Group, Revised Study Design)|Control Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received sham stimulation therapy.
11170331|NCT01996254|EG000|Reported Event|Initial Study Design Subjects|Subjects who were consented and enrolled under the initial design of the study.
11170332|NCT01996254|EG001|Reported Event|Group 1 (Treatment Group, Revised Study Design)|Treatment Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received electrical stimulation therapy.
11170333|NCT01996254|EG002|Reported Event|Group 2 (Control Group, Revised Study Design)|Control Group subjects were consented and enrolled under the revised study design. These subjects had at least one Lead placed and received sham stimulation therapy.
10850999|NCT03138096|OG000|Outcome|Group 1 - Five Pb(PfCS@UIS4)-Infected Mosquitoes|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
10851000|NCT03138096|OG000|Outcome|Group 1 - Five Pb(PfCS@UIS4)-Infected Mosquitoes|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~No humoral responses measured"
11170334|NCT01996319|BG000|Baseline|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
11170335|NCT01996319|BG001|Baseline|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
11170336|NCT01996319|BG002|Baseline|Total|Total of all reporting groups
10851001|NCT03138096|OG001|Outcome|Group 2 - 25 Pb(PfCS@UIS4)-Infected Mosquito Bites|"(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~No humoral responses measured"
11170337|NCT01996319|FG000|Participant Flow|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
11170338|NCT01996319|FG001|Participant Flow|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
11170339|NCT01996319|OG000|Outcome|QVA149|
11170340|NCT01996319|OG001|Outcome|Placebo|
11170341|NCT01996319|EG000|Reported Event|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
11170342|NCT01996319|EG001|Reported Event|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
11170343|NCT01996332|BG000|Baseline|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
11357022|NCT03768206|FG000|Participant Flow|PATH|"PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.~Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement~Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement."
11170344|NCT01996332|FG000|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|Participants received erlotinib 150 milligrams/day (mg/day), orally, until progressive disease or unacceptable toxicity.
11170345|NCT01996332|OG000|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
11170346|NCT01996332|EG000|Reported Event|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
11357023|NCT03768206|FG001|Participant Flow|PATH-12|"PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.~Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement~Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement."
11357024|NCT03768206|OG000|Outcome|Total Participants Approached|The total number of participants that were screened for participation in the study
11357025|NCT03768206|OG000|Outcome|PATH|"PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.~Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement~Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement."
11357026|NCT03768206|OG001|Outcome|PATH-12|"PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.~Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement~Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement."
11357027|NCT03768206|EG000|Reported Event|PATH|"PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.~Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement~Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement."
11357028|NCT03768206|EG001|Reported Event|PATH-12|"PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.~Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement~Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement."
11357029|NCT03767894|BG000|Baseline|MyHand Orthosis|"Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.~EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.~Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression."
11357030|NCT03767894|FG000|Participant Flow|MyHand Orthosis|"Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.~EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.~Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression."
11357031|NCT03767894|OG000|Outcome|MyHand Orthosis|"Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.~EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.~Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression."
11357032|NCT03767894|EG000|Reported Event|MyHand Orthosis|"Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.~EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.~Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression."
11357033|NCT03767738|BG000|Baseline|Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg|Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
11357034|NCT03767738|BG001|Baseline|Cohort 2: IAI 2 mg|Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
11357035|NCT03767738|BG002|Baseline|Total|Total of all reporting groups
11357036|NCT03767738|FG000|Participant Flow|Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg|Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
11357037|NCT03767738|FG001|Participant Flow|Cohort 2: IAI 2 mg|Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
11357038|NCT03767738|OG000|Outcome|Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg|Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
11357039|NCT03767738|OG001|Outcome|Cohort 2: IAI 2 mg|Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
11357040|NCT03767738|EG000|Reported Event|Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg|Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
11357041|NCT03767738|EG001|Reported Event|Cohort 2: IAI 2 mg|Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
11170347|NCT01996592|BG000|Baseline|Cesarean Section Deliveries|those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively
11170348|NCT01996592|FG000|Participant Flow|Cesarean Section Deliveries|those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively
11170349|NCT01996592|OG000|Outcome|Group 1-perceived Stress Scores|Subjects who had the fastest recovery
11170350|NCT01996592|OG001|Outcome|Group 2 Perceived Stress Scale|Subjects who experienced average recovery
11170351|NCT01996592|OG002|Outcome|Group 3 Perceived Stress Scale|Subjects who experienced the slowest recovery from surgery
11170352|NCT01996592|OG000|Outcome|Group 1-emotional Distress Scores|Subjects who had the fastest recovery
11170353|NCT01996592|OG001|Outcome|Group 2 Emotional Distress Scale|Subjects who experienced average recovery
11170354|NCT01996592|OG002|Outcome|Group 3 Emotional Distress Scale|Subjects who experienced the slowest recovery from surgery
11170355|NCT01996592|EG000|Reported Event|Cesarean Section Deliveries|those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively
11170356|NCT01996644|BG000|Baseline|Setraline|"250 mg DCS (setraline) versus placebo~Sertaline"
11170357|NCT01996644|BG001|Baseline|Placebo|Placebo Group
11170358|NCT01996644|BG002|Baseline|Total|Total of all reporting groups
11170359|NCT01996644|FG000|Participant Flow|Setraline|"250 mg DCS (setraline)~Sertaline"
10851002|NCT03138096|EG000|Reported Event|Group 1|"(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
11170360|NCT01996644|FG001|Participant Flow|Placebo|Placebo group
11170361|NCT01996644|OG000|Outcome|Setraline|"250 mg DCS (setraline) versus placebo~Placebo vs Setraline: Placebo"
11170362|NCT01996644|OG001|Outcome|Placebo|"Placebo group~Placebo vs Setraline: Placebo"
11170363|NCT01996644|OG000|Outcome|Setraline|"250 mg DCS (setraline) versus placebo~Sertaline"
11170364|NCT01996644|OG001|Outcome|Placebo|"Placebo group~Sertaline"
11170365|NCT01996644|OG002|Outcome|All Combined|Setraline and Placebo groups
11170366|NCT01996644|EG000|Reported Event|Setraline|"250 mg DCS (setraline) versus placebo~Sertaline"
11170367|NCT01996644|EG001|Reported Event|Placebo|"Placebo group~Sertaline"
11170368|NCT01996657|BG000|Baseline|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
11170369|NCT01996657|BG001|Baseline|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
11170370|NCT01996657|BG002|Baseline|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
11170371|NCT01996657|BG003|Baseline|Total|Total of all reporting groups
11170372|NCT01996657|FG000|Participant Flow|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
11170373|NCT01996657|FG001|Participant Flow|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
11170374|NCT01996657|FG002|Participant Flow|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
11170375|NCT01996657|OG000|Outcome|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
11170376|NCT01996657|OG001|Outcome|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
11170377|NCT01996657|OG002|Outcome|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
11170378|NCT01996657|EG000|Reported Event|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
11170379|NCT01996657|EG001|Reported Event|D-dimer-guided Adjustmentd of Anticoagutlation Intensity|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
11170380|NCT01996657|EG002|Reported Event|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
11170381|NCT01996709|BG000|Baseline|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
11170382|NCT01996709|BG001|Baseline|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
11170383|NCT01996709|BG002|Baseline|Total|Total of all reporting groups
11170384|NCT01996709|FG000|Participant Flow|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
11170385|NCT01996709|FG001|Participant Flow|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
11170386|NCT01996709|OG000|Outcome|Clear Care, Right Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
11170387|NCT01996709|OG001|Outcome|Clear Care, Left Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
11170388|NCT01996709|OG002|Outcome|Habitual MPS, Right Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
10851003|NCT03138096|EG001|Reported Event|Group 2|"(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes"
11170389|NCT01996709|OG003|Outcome|Habitual MPS, Left Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
10851004|NCT03138096|EG002|Reported Event|Group 3|"(group 3) will be exposed to 75 Pb(PfCS@UIS4)-infected mosquito bites~Pb(PfCS@UIS4)-infected mosquitoes: Pb(PfCS@UIS4)-infected mosquitoes~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
10851005|NCT03138096|EG003|Reported Event|Group 4|"Infectivity control group~Challenge infection P. falciparum: Challenge infection with bites of five infected Pf mosquitoes"
11170390|NCT01996709|OG000|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
10888035|NCT00504348|OG000|Outcome|Prospective Investigation Group|"Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.~Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg."
10888036|NCT00504348|EG000|Reported Event|Prospective Investigation Group|"Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.~Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg."
10888037|NCT00504426|BG000|Baseline|Placebo|Placebo of OPC-249/vial
10888038|NCT00504426|BG001|Baseline|OPC-249 (30IU)|30 IU of OPC-249/vial
10888039|NCT00504426|BG002|Baseline|OPC-249 (60IU)|60 IU of OPC-249/vial
10888040|NCT00504426|BG003|Baseline|OPC-249 (120IU)|120 IU of OPC-249/vial
10888041|NCT00504426|BG004|Baseline|Total|Total of all reporting groups
11170391|NCT01996709|OG001|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
11170392|NCT01996709|EG000|Reported Event|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
11357042|NCT03767153|BG000|Baseline|80 Pin Applicator|"Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
11357043|NCT03767153|BG001|Baseline|160 Pin Applicator|"Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
10888042|NCT00504426|FG000|Participant Flow|Placebo|Placebo of OPC-249/vial
10888043|NCT00504426|FG001|Participant Flow|OPC-249 (30IU)|30 IU of OPC-249/vial
10888044|NCT00504426|FG002|Participant Flow|OPC-249 (60IU)|60 IU of OPC-249/vial
10888045|NCT00504426|FG003|Participant Flow|OPC-249 (120IU)|120 IU of OPC-249/vial
10888046|NCT00504426|OG000|Outcome|Placebo|Placebo of OPC-249/vial
10888047|NCT00504426|OG001|Outcome|OPC-249 (30IU)|30 IU of OPC-249 /vial
10888048|NCT00504426|OG002|Outcome|OPC-249 (60IU)|60 IU of OPC-249 /vial
10888049|NCT00504426|OG003|Outcome|OPC-249 (120IU)|120 IU of OPC-249 /vial
10888050|NCT00504426|OG001|Outcome|OPC-249 (30IU)|30 IU of OPC-249/vial
10888051|NCT00504426|OG002|Outcome|OPC-249 (60IU)|60 IU of OPC-249/vial
10888052|NCT00504426|OG003|Outcome|OPC-249 (120IU)|120 IU of OPC-249/vial
10888053|NCT00504426|EG000|Reported Event|Placebo|Placebo of OPC-249/vial
10888054|NCT00504426|EG001|Reported Event|OPC-249 (30IU)|30 IU of OPC-249/vial
10888055|NCT00504426|EG002|Reported Event|OPC-249 (60IU)|60 IU of OPC-249/vial
10888056|NCT00504426|EG003|Reported Event|OPC-249 (120IU)|120 IU of OPC-249/vial
11170393|NCT01996709|EG001|Reported Event|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
11170394|NCT01996748|BG000|Baseline|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
11170395|NCT01996748|BG001|Baseline|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
11170396|NCT01996748|BG002|Baseline|Total|Total of all reporting groups
11357044|NCT03767153|BG002|Baseline|Total|Total of all reporting groups
11357045|NCT03767153|FG000|Participant Flow|80 Pin Applicator|"Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
11170397|NCT01996748|FG000|Participant Flow|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
11170398|NCT01996748|FG001|Participant Flow|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
11170399|NCT01996748|OG000|Outcome|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
11170400|NCT01996748|OG001|Outcome|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
11170401|NCT01996748|OG000|Outcome|DF277|Two administrations daily for 7 days
11170402|NCT01996748|OG001|Outcome|Placebo|Two administrations daily for 7 days
11170403|NCT01996748|EG000|Reported Event|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
11170404|NCT01996748|EG001|Reported Event|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
10851006|NCT02678351|BG000|Baseline|68Ga-PSMA PET/MRI|"Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.~68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI"
11170405|NCT01996813|BG000|Baseline|Historical Control|Patients with a BMI of 30 kg/m^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.
11170406|NCT01996813|BG001|Baseline|Prospective Case|Patients with a BMI of 30 kg/m^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.
11170407|NCT01996813|BG002|Baseline|Total|Total of all reporting groups
11357046|NCT03767153|FG001|Participant Flow|160 Pin Applicator|"Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
11170408|NCT01996813|FG000|Participant Flow|Prospective Case|Patients with a BMI of 30 kg/m^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.
11170409|NCT01996813|FG001|Participant Flow|Historical Control|Patients with a BMI of 30 kg/m^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.
11170410|NCT01996813|OG000|Outcome|Historical Control|Patients with a BMI of 30 kg/m^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.
11170411|NCT01996813|OG001|Outcome|Prospective Case|Patients with a BMI of 30 kg/m^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.
11170412|NCT01996813|EG000|Reported Event|Historical Control|Patients with a BMI of 30 kg/m^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.
11170413|NCT01996813|EG001|Reported Event|Prospective Case|Patients with a BMI of 30 kg/m^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.
11170414|NCT01996826|BG000|Baseline|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
11170415|NCT01996826|BG001|Baseline|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks."
11170416|NCT01996826|BG002|Baseline|Total|Total of all reporting groups
11170417|NCT01996826|FG000|Participant Flow|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
11170418|NCT01996826|FG001|Participant Flow|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks."
11170419|NCT01996826|OG000|Outcome|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
11232986|NCT02423343|BG001|Baseline|Galunisertib + Nivolumab (Cohort 2) Phase 1b|50 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11170420|NCT01996826|OG001|Outcome|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks."
11170421|NCT01996826|EG000|Reported Event|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
11170422|NCT01996826|EG001|Reported Event|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks."
11170423|NCT01996839|BG000|Baseline|Vehicle (BID and TID)|"Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID) and three times daily (TID), combined arms~One drop of vehicle instilled into the study eye two times per day (BID) and three times a day (TID) for 14 days"
11170424|NCT01996839|BG001|Baseline|Loteprednol Etabonate Gel (BID)|"Loteprednol Etabonate Gel 0.38% administered two times daily (BID).~Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days"
11170425|NCT01996839|BG002|Baseline|Loteprednol Etabonate Gel (TID)|"Loteprednol Gel 0.38% administered three times daily (TID).~Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days."
11170426|NCT01996839|BG003|Baseline|Total|Total of all reporting groups
11170427|NCT01996839|FG000|Participant Flow|Vehicle (BID and TID)|"Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID) and three times daily (TID), combined arms~One drop of vehicle instilled into the study eye two times per day (BID) and three times a day (TID) for 14 days"
11170428|NCT01996839|FG001|Participant Flow|Loteprednol Etabonate Gel (BID)|"Loteprednol Etabonate Gel 0.38% administered two times daily (BID).~Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days"
11170429|NCT01996839|FG002|Participant Flow|Loteprednol Etabonate Gel (TID)|"Loteprednol Gel 0.38% administered three times daily (TID).~Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days."
11170430|NCT01996839|OG000|Outcome|Vehicle (BID and TID)|"Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID) and three times daily (TID), combined arms~One drop of vehicle instilled into the study eye two times per day (BID) and three times a day (TID) for 14 days"
11170431|NCT01996839|OG001|Outcome|Loteprednol Etabonate Gel (BID)|"Loteprednol Etabonate Gel 0.38% administered two times daily (BID).~Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days"
11170432|NCT01996839|OG002|Outcome|Loteprednol Etabonate Gel (TID)|"Loteprednol Gel 0.38% administered three times daily (TID).~Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days."
11170433|NCT01996839|EG000|Reported Event|Vehicle (BID and TID)|"Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID) and three times daily (TID), combined arms~One drop of vehicle instilled into the study eye two times per day (BID) and three times a day (TID) for 14 days"
11170434|NCT01996839|EG001|Reported Event|Loteprednol Etabonate Gel (BID)|"Loteprednol Etabonate Gel 0.38% administered two times daily (BID).~Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days"
11170435|NCT01996839|EG002|Reported Event|Loteprednol Etabonate Gel (TID)|"Loteprednol Gel 0.38% administered three times daily (TID).~Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days."
11170436|NCT01996904|BG000|Baseline|Arthroscopic Repair|"Lateral-anterosuperior portal (Miracle Portal) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
11357047|NCT03767153|OG000|Outcome|80 Pin Applicator|"Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
11357048|NCT03767153|OG001|Outcome|160 Pin Applicator|"Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
11357049|NCT03767153|EG000|Reported Event|80 Pin Applicator|"Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
11357050|NCT03767153|EG001|Reported Event|160 Pin Applicator|"Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
11357051|NCT03767062|BG000|Baseline|Topiramate|"Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.~Topamax: An antiepileptic agent used for migraine prophylaxis."
11357052|NCT03767062|BG001|Baseline|Greater Occipital +Supratrochlear Nerve Block|"Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼ (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.~Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves."
11357053|NCT03767062|BG002|Baseline|Total|Total of all reporting groups
11357054|NCT03767062|FG000|Participant Flow|Topiramate|"Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.~Topamax: An antiepileptic agent used for migraine prophylaxis."
11357055|NCT03767062|FG001|Participant Flow|Greater Occipital +Supratrochlear Nerve Block|"Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼ (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.~Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves."
11357056|NCT03767062|OG000|Outcome|Topiramate|"Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.~Topamax: An antiepileptic agent used for migraine prophylaxis."
11357057|NCT03767062|OG001|Outcome|Greater Occipital +Supratrochlear Nerve Block|"Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼ (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.~Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves."
11357058|NCT03767062|EG000|Reported Event|Topiramate|"Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.~Topamax: An antiepileptic agent used for migraine prophylaxis."
11357059|NCT03767062|EG001|Reported Event|Greater Occipital +Supratrochlear Nerve Block|"Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼ (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.~Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves."
11357060|NCT03766646|BG000|Baseline|Speech|"Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.~Optiflow: 45l.min oxygen"
11357061|NCT03766646|BG001|Baseline|Non-speech|"Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.~Optiflow: 45l.min oxygen"
11357062|NCT03766646|BG002|Baseline|Total|Total of all reporting groups
11357063|NCT03766646|FG000|Participant Flow|Speech|"Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.~Optiflow: 45l.min oxygen"
11357064|NCT03766646|FG001|Participant Flow|Non-speech|"Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.~Optiflow: 45l.min oxygen"
11357065|NCT03766646|OG000|Outcome|Speech|"Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.~Optiflow: 45l.min oxygen"
11357066|NCT03766646|OG001|Outcome|Non-speech|"Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.~Optiflow: 45l.min oxygen"
11357067|NCT03766646|EG000|Reported Event|Speech|"Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.~Optiflow: 45l.min oxygen~All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed."
11357068|NCT03766646|EG001|Reported Event|Non-speech|"Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded.~Optiflow: 45l.min oxygen~All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed."
11357069|NCT03766373|BG000|Baseline|Drug: OP0201|Drug: OP0201 20mg: OP0201
11357070|NCT03766373|BG001|Baseline|Drug: Placebo|Drug: Placebo 0mg: Placebo
11357071|NCT03766373|BG002|Baseline|Total|Total of all reporting groups
11357072|NCT03766373|FG000|Participant Flow|Drug: OP0201|Drug: OP0201 20mg: OP0201
11357073|NCT03766373|FG001|Participant Flow|Drug: Placebo|Drug: Placebo 0mg: Placebo
11357074|NCT03766373|OG000|Outcome|Drug: OP0201|Drug: OP0201 20mg: OP0201
11357075|NCT03766373|OG001|Outcome|Drug: Placebo|Drug: Placebo 0mg: Placebo
11357076|NCT03766373|EG000|Reported Event|Drug: OP0201|Drug: OP0201 20mg: OP0201
11357077|NCT03766373|EG001|Reported Event|Drug: Placebo|Drug: Placebo 0mg: Placebo
11357078|NCT03766165|BG000|Baseline|Intervention|"Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.~Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant."
11357079|NCT03766165|BG001|Baseline|Control|"Job announcements only~Control: Participants will receive job announcements only."
11357080|NCT03766165|BG002|Baseline|Total|Total of all reporting groups
11357081|NCT03766165|FG000|Participant Flow|Intervention|"Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.~Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant."
11357082|NCT03766165|FG001|Participant Flow|Control|"Job announcements only~Control: Participants will receive job announcements only."
11357083|NCT03766165|OG000|Outcome|Intervention|"Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.~Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant."
11357084|NCT03766165|OG001|Outcome|Control|"Job announcements only~Control: Participants will receive job announcements only."
11357085|NCT03766165|OG000|Outcome|All Participants|All participants including those in intervention arm and control arm
11357086|NCT03766165|EG000|Reported Event|Intervention|"Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.~Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant."
11357087|NCT03766165|EG001|Reported Event|Control|"Job announcements only~Control: Participants will receive job announcements only."
11170437|NCT01996904|BG001|Baseline|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
11170438|NCT01996904|BG002|Baseline|Total|Total of all reporting groups
11357088|NCT03765996|BG000|Baseline|Decongestive Physiotherapy|"This group received Complex Decongestive Physiotherapy.~Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow."
11357089|NCT03765996|BG001|Baseline|Decongestive Physiotherapy Plus Taping|"This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.~Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region."
11357090|NCT03765996|BG002|Baseline|Total|Total of all reporting groups
11357091|NCT03765996|FG000|Participant Flow|Decongestive Physiotherapy|"This group received Complex Decongestive Physiotherapy.~Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow."
11357092|NCT03765996|FG001|Participant Flow|Decongestive Physiotherapy Plus Taping|"This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.~Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region."
11357093|NCT03765996|OG000|Outcome|Decongestive Physiotherapy|"This group received Complex Decongestive Physiotherapy.~Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow."
11357094|NCT03765996|OG001|Outcome|Decongestive Physiotherapy Plus Taping|"This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.~Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region."
11357095|NCT03765996|EG000|Reported Event|Decongestive Physiotherapy|"This group received Complex Decongestive Physiotherapy.~Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow."
11357096|NCT03765996|EG001|Reported Event|Decongestive Physiotherapy Plus Taping|"This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.~Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region."
11357097|NCT03765762|BG000|Baseline|GRF6019|GRF6019 250 mL IV for 5 consecutive days
11357098|NCT03765762|BG001|Baseline|Placebo|Placebo 250 mL IV for 5 consecutive days
11357099|NCT03765762|BG002|Baseline|Total|Total of all reporting groups
11357100|NCT03765762|FG000|Participant Flow|GRF6019|GRF6019 250 mL IV for 5 consecutive days
11357101|NCT03765762|FG001|Participant Flow|Placebo|Placebo 250 mL IV for 5 consecutive days
11357102|NCT03765762|OG000|Outcome|GRF6019|GRF6019 250 mL IV for 5 consecutive days
11357103|NCT03765762|OG001|Outcome|Placebo|Placebo 250 mL IV for 5 consecutive days
11357104|NCT03765762|EG000|Reported Event|GRF6019|GRF6019 250 mL IV for 5 consecutive days
11357105|NCT03765762|EG001|Reported Event|Placebo|Placebo 250 mL IV for 5 consecutive days
11357106|NCT03765502|BG000|Baseline|Part A Trained Users|All trained participants in Part A
11357107|NCT03765502|BG001|Baseline|Part A Participants With Diabetes|All participants with diabetes in Part A
11357108|NCT03765502|BG002|Baseline|Part B Untrained Users|All participants in Part B.
11357109|NCT03765502|BG003|Baseline|Total|Total of all reporting groups
11357110|NCT03765502|FG000|Participant Flow|Part A Trained Users NG/GEK|"Simulation 1: Day 8 participants were trained to administer an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.~Simulation 2: Day 15 participants were trained to administer a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.~No drug was administered to humans in either simulation."
11357111|NCT03765502|FG001|Participant Flow|Part A Trained Users GEK/NG|"Simulation 1: Day 8 participants were trained to administer a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.~Simulation 2: Day 15 participants were trained to administer an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.~No drug was administered to humans in either simulation."
11357112|NCT03765502|FG002|Participant Flow|Part A Person With Diabetes (PWD)|"Day 1 - PWD trained participants to administer a glucose emergency kit intramuscularly or an empty nasal glucagon device (depending on randomization).~Simulation 1: Day 8 - PWD trained participants to administer an empty nasal glucagon device or a glucose emergency kit intramuscularly(depending on randomization).~No drug was administered to humans in either simulation."
11357113|NCT03765502|FG003|Participant Flow|Part B Untrained Users NG/GEK|"Simulation1: Day 1 untrained participants administered an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.~Simulations 2: Day 8 untrained participants administered a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.~No drug was administered to humans in either simulation."
11357114|NCT03765502|FG004|Participant Flow|Part B Untrained Users GEK/NG|"Simulation 1: Day 1 untrained participants administered a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.~Simulation 2: Day 8 untrained participants administered an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.~No drug was administered to humans in either simulation."
11357115|NCT03765502|OG000|Outcome|Nasal Glucagon (NG)|Trained participants who found and had a successful administration of NG rescue device.
11357116|NCT03765502|OG001|Outcome|Glucagon Emergency Kit (GEK)|Trained participants who found had a successful administration of the GEK rescue device.
11357117|NCT03765502|OG000|Outcome|Nasal Glucagon (NG)|Participants who were not trained on the administration of NG rescue device.
11357118|NCT03765502|OG001|Outcome|Glucagon Emergency Kit (GEK)|Participants who were not trained on the administration of the GEK.
11357119|NCT03765502|OG000|Outcome|Nasal Glucagon (NG)|Trained participants who found device and had a successful administration of NG rescue device.
11357120|NCT03765502|OG001|Outcome|Glucagon Emergency Kit (GEK)|Trained participants who found device and had a successful administration of GEK rescue device.
11357121|NCT03765502|OG000|Outcome|Nasal Glucagon Device (NG)|Untrained participants who found device and had a successful administration of NG rescue device.
11357122|NCT03765502|OG001|Outcome|Glucagon Emergency Kit (GEK)|Untrained participants who found device and had a successful administration of GEK rescue device.
11357123|NCT03765502|OG000|Outcome|Part A (Trained)|Overall preference for Trained users (Part A) for rescue device, NG and GEK.
11357124|NCT03765502|OG001|Outcome|Part B (Untrained)|Overall preference for Untrained users (Part B) for rescue device, NG and GEK.
11357125|NCT03765502|OG000|Outcome|Participant With Diabetes (PWD)|Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.
11357126|NCT03765502|OG000|Outcome|Part A (Trained)|Overall ease of use for Trained users (Part A) for rescue device, NG and GEK.
11357127|NCT03765502|OG001|Outcome|Part B (Untrained)|Overall ease of use for Untrained users (Part B) for rescue device, NG and GEK.
11357128|NCT03765502|EG000|Reported Event|Part A Trained Users Nasal Glucagon (NG)|Trained users NG.
11357129|NCT03765502|EG001|Reported Event|Part A Trained Users Glucagon Emergency Kit (GEK)|Trained user GEK.
11357130|NCT03765502|EG002|Reported Event|Part A Participants With Diabetes (PWD)|PWD
11357131|NCT03765502|EG003|Reported Event|Part B Untrained Users NG|Untrained user NG.
11357132|NCT03765502|EG004|Reported Event|Part B Untrained Users GEK|Untrained user GEK.
11357133|NCT03765164|BG000|Baseline|Control|"Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.~Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online"
11357134|NCT03765164|BG001|Baseline|Intervention|"Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.~GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients~Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online"
11357135|NCT03765164|BG002|Baseline|Total|Total of all reporting groups
11357136|NCT03765164|FG000|Participant Flow|Control|"Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.~Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online"
10851007|NCT02678351|FG000|Participant Flow|68Ga-PSMA PET/MRI|"Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.~68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI"
11174197|NCT02020135|EG001|Reported Event|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
11174198|NCT02020252|BG000|Baseline|Touchscreen Participants|Testing Interactive Technology
11357137|NCT03765164|FG001|Participant Flow|Intervention|"Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.~GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients~Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online"
11357138|NCT03765164|OG000|Outcome|Control|"Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.~Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online"
11357139|NCT03765164|OG001|Outcome|Intervention|"Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.~GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients~Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online"
11357140|NCT03765164|EG000|Reported Event|Control|"Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.~Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online"
11357141|NCT03765164|EG001|Reported Event|Intervention|"Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.~GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients~Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online"
11357142|NCT03765138|BG000|Baseline|PE/Pramipexole|"Experimental: Prolonged Exposure (PE)/Pramipexole PE Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. In addition to receiving PE as described above, patients will have Pramipexole treatment.~PE/Pramipexole: Experimental: PE/Pramipexole PE Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation.~Pramipexole: In addition to receiving PE as described above, patients will have Pramipexole treatment. Daily dose will be started at 0.25 mg/day and increased by 0.25 mg/day every 3-4 days to a target of 2.5mg day by week 5. Beginning week 6 daily dose will be increased weekly by 0.5 mg/day to a maximum dose of 4mg. Dose will be increased as tolerated unless the patient has achieved remission and will be decreased in the event of intolerance."
11357143|NCT03765138|FG000|Participant Flow|PE/Pramipexole|"Experimental: Prolonged Exposure (PE)/Pramipexole PE Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. In addition to receiving PE as described above, patients will have Pramipexole treatment.~PE/Pramipexole: Experimental: PE/Pramipexole PE Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation.~Pramipexole: In addition to receiving PE as described above, patients will have Pramipexole treatment. Daily dose will be started at 0.25 mg/day and increased by 0.25 mg/day every 3-4 days to a target of 2.5mg day by week 5. Beginning week 6 daily dose will be increased weekly by 0.5 mg/day to a maximum dose of 4mg. Dose will be increased as tolerated unless the patient has achieved remission and will be decreased in the event of intolerance."
11357144|NCT03765138|OG000|Outcome|PE/Pramipexole|"Experimental: Prolonged Exposure (PE)/Pramipexole PE Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. In addition to receiving PE as described above, patients will have Pramipexole treatment.~PE/Pramipexole: Experimental: PE/Pramipexole PE Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation.~Pramipexole: In addition to receiving PE as described above, patients will have Pramipexole treatment. Daily dose will be started at 0.25 mg/day and increased by 0.25 mg/day every 3-4 days to a target of 2.5mg day by week 5. Beginning week 6 daily dose will be increased weekly by 0.5 mg/day to a maximum dose of 4mg. Dose will be increased as tolerated unless the patient has achieved remission and will be decreased in the event of intolerance."
11357145|NCT03765138|OG000|Outcome|PE/Pramipexole|"Experimental: Prolonged Exposure/Pramipexole Prolonged Exposure (PE) Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. In addition to receiving PE as described above, patients will have Pramipexole treatment.~PE/Pramipexole: Experimental: PE/Pramipexole Prolonged Exposure (PE) Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation.~Pramipexole: In addition to receiving PE as described above, patients will have Pramipexole treatment. Daily dose will be started at 0.25 mg/day and increased by 0.25 mg/day every 3-4 days to a target of 2.5mg day by week 5. Beginning week 6 daily dose will be increased weekly by 0.5 mg/day to a maximum dose of 4mg. Dose will be increased as tolerated unless the patient has achieved remission."
11357439|NCT03757988|OG000|Outcome|Single Arm Experimental Walking Group|"This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.~Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it."
11170439|NCT01996904|FG000|Participant Flow|Arthroscopic Repair|"Lateral-anterosuperior portal (Miracle Portal) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
11170440|NCT01996904|FG001|Participant Flow|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
10851008|NCT02678351|OG000|Outcome|68Ga-PSMA PET/MRI|"Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.~68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI"
11232987|NCT02423343|BG002|Baseline|Galunisertib + Nivolumab (Cohort 3) Phase 1b|80 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks(Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11232988|NCT02423343|BG003|Baseline|Galunisertib + Nivolumab (Cohort 4) Phase 1b|150 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11232989|NCT02423343|BG004|Baseline|Galunisertib + Nivolumab - Non Small Cell Lung Cancer (NSCLC) Phase 2|150 mg Galunisertib given orally twice daily for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11232990|NCT02423343|BG005|Baseline|Galunisertib + Nivolumab - Hepatocellular Carcinoma(HCC) Phase 2|150 mg Galunisertib given orally twice daily for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11232991|NCT02423343|BG006|Baseline|Total|Total of all reporting groups
11232992|NCT02423343|FG000|Participant Flow|Galunisertib + Nivolumab (Cohort 1) Phase 1b|50 milligram (mg) Galunisertib administered orally daily (QD) on Day 1 through Day 14 of each 4-week cycle in combination with 3 milligrams per kilogram (3 mg/kg) nivolumab given intravenously (IV), every 2 weeks (Q2W), on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11232993|NCT02423343|FG001|Participant Flow|Galunisertib + Nivolumab (Cohort 2) Phase 1b|50 mg Galunisertib administered orally twice daily (BID) on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11232994|NCT02423343|FG002|Participant Flow|Galunisertib + Nivolumab (Cohort 3) Phase 1b|80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11232995|NCT02423343|FG003|Participant Flow|Galunisertib + Nivolumab (Cohort 4) Phase 1b|150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11232996|NCT02423343|FG004|Participant Flow|Galunisertib + Nivolumab - Non-Small Cell Lung Cancer (NSCLC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11232997|NCT02423343|FG005|Participant Flow|Galunisertib + Nivolumab - Hepatocellular Carcinoma (HCC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11232998|NCT02423343|OG000|Outcome|Phase 1b Participants|"Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles.~Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.~Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.~Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles."
11232999|NCT02423343|OG000|Outcome|Galunisertib + Nivolumab (Cohort 1) Phase 1b|50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles.
11170441|NCT01996904|OG000|Outcome|Arthroscopic Repair|"Lateral-anterosuperior portal (Miracle Portal) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
11170442|NCT01996904|OG001|Outcome|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
11170443|NCT01996904|EG000|Reported Event|Arthroscopic Repair|"Lateral-anterosuperior portal (Miracle Portal) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
11170444|NCT01996904|EG001|Reported Event|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
11170445|NCT01996917|BG000|Baseline|Prineo Closure OR Standard Suture|"One breast will have skin closure with Prineo.~Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.~OR~One breast will be closed in the standard fashion with suture."
11170446|NCT01996917|FG000|Participant Flow|Prineo Closure OR Standard Suture|"One breast will have skin closure with Prineo.~Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.~OR~One breast will be closed in the standard fashion with suture."
11170447|NCT01996917|OG000|Outcome|Prineo Closure|"One breast will have skin closure with Prineo.~Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures."
11170448|NCT01996917|OG001|Outcome|Standard Suture|One breast will be closed in the standard fashion with suture.
11170449|NCT01996917|EG000|Reported Event|Prineo Closure OR Standard Suture|"One breast will have skin closure with Prineo.~Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.~OR~One breast will be closed in the standard fashion with suture."
11170450|NCT01996943|BG000|Baseline|Placebo|"The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.~Placebo: The placebo with be 0.45% saline solution (half normal saline)."
11170451|NCT01996943|BG001|Baseline|Ethanol|"Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.~Ethanol: 6% volume/volume ethanol in 0.45% saline solution."
11170452|NCT01996943|BG002|Baseline|Total|Total of all reporting groups
11170453|NCT01996943|FG000|Participant Flow|Placebo|"The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.~Placebo: The placebo with be 0.45% saline solution (half normal saline)."
11233000|NCT02423343|OG001|Outcome|Galunisertib + Nivolumab (Cohort 2) Phase 1b|50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.
11233001|NCT02423343|OG002|Outcome|Galunisertib + Nivolumab (Cohort 3) Phase 1b|80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.
11170454|NCT01996943|FG001|Participant Flow|Ethanol|"Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.~Ethanol: 6% volume/volume ethanol in 0.45% saline solution."
11170455|NCT01996943|OG000|Outcome|Placebo|"The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.~Placebo: The placebo with be 0.45% saline solution (half normal saline)."
11233002|NCT02423343|OG003|Outcome|Galunisertib + Nivolumab (Cohort 4) Phase 1b|150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.
11233003|NCT02423343|OG004|Outcome|Galunisertib + Nivolumab (NSCLC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233004|NCT02423343|OG005|Outcome|Galunisertib + Nivolumab ( HCC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233005|NCT02423343|OG000|Outcome|Galunisertib + Nivolumab (Cohort 1) Phase 1b|50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233006|NCT02423343|OG001|Outcome|Galunisertib + Nivolumab (Cohort 2) Phase 1b|50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233007|NCT02423343|OG002|Outcome|Galunisertib + Nivolumab (Cohort 3) Phase 1b|80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233008|NCT02423343|OG003|Outcome|Galunisertib + Nivolumab (Cohort 4) Phase 1b|150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233009|NCT02423343|OG004|Outcome|Galunisertib + Nivolumab (NSCLC ) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233010|NCT02423343|OG000|Outcome|Galunisertib + Nivolumab (Cohort 1) Phase 1b|50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233011|NCT02423343|OG001|Outcome|Galunisertib + Nivolumab (Cohort 2) Phase 1b|50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233012|NCT02423343|OG002|Outcome|Galunisertib + Nivolumab (Cohort 3) Phase 1b|80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233013|NCT02423343|OG003|Outcome|Galunisertib + Nivolumab (Cohort 4) Phase 1b|150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233014|NCT02423343|OG005|Outcome|Galunisertib + Nivolumab (HCC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233015|NCT02423343|OG000|Outcome|Galunisertib + Nivolumab (NSCLC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233016|NCT02423343|OG001|Outcome|Galunisertib + Nivolumab (HCC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233017|NCT02423343|OG001|Outcome|Galunisertib + Nivolumab (HCC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233018|NCT02423343|EG000|Reported Event|Galunisertib + Nivolumab (Cohort 1) Phase 1b|50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233019|NCT02423343|EG001|Reported Event|Galunisertib + Nivolumab (Cohort 2) Phase 1b|50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233020|NCT02423343|EG002|Reported Event|Galunisertib + Nivolumab (Cohort 3) Phase 1b|80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233021|NCT02423343|EG003|Reported Event|Galunisertib + Nivolumab (Cohort 4) Phase 1b|150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
11233022|NCT02423343|EG004|Reported Event|Galunisertib + Nivolumab (NSCLC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233023|NCT02423343|EG005|Reported Event|Galunisertib + Nivolumab (HCC) Phase 2|150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
11233024|NCT02423408|BG000|Baseline|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
11233025|NCT02423408|BG001|Baseline|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
11233026|NCT02423408|BG002|Baseline|Total|Total of all reporting groups
11233027|NCT02423408|FG000|Participant Flow|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
11233028|NCT02423408|FG001|Participant Flow|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
11233029|NCT02423408|OG000|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
11233030|NCT02423408|OG001|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
11233031|NCT02423408|EG000|Reported Event|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
11233032|NCT02423408|EG001|Reported Event|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
11233033|NCT02423447|BG000|Baseline|All Study Participants|"Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines.~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines."
11170456|NCT01996943|OG001|Outcome|Ethanol|"Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.~Ethanol: 6% volume/volume ethanol in 0.45% saline solution."
11170457|NCT01996943|EG000|Reported Event|Placebo|"The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.~Placebo: The placebo with be 0.45% saline solution (half normal saline)."
11170458|NCT01996943|EG001|Reported Event|Ethanol|"Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.~Ethanol: 6% volume/volume ethanol in 0.45% saline solution."
11170459|NCT01997125|BG000|Baseline|Neural Bridge System - Open Label|"Neural bridge system implant and external stimulator~Neural Bridge System: Implanted device"
11170460|NCT01997125|FG000|Participant Flow|Neural Bridge System - Open Label|"Neural bridge system implant and external stimulator~Neural Bridge System: Implanted device"
11170461|NCT01997125|OG000|Outcome|Neural Bridge System - Open Label|"Neural bridge system implant and external stimulator~Neural Bridge System: Implanted device"
11170462|NCT01997125|EG000|Reported Event|Open Label|"Neural bridge system implant and external stimulator~Neural Bridge System: Implanted device"
11170463|NCT01997216|BG000|Baseline|Overall|Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each.
11170464|NCT01997216|FG000|Participant Flow|Delefilcon A MF, Then AOAMF|Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
11170465|NCT01997216|FG001|Participant Flow|AOAMF, Then Delefilcon A MF|Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
11170466|NCT01997216|OG000|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
11170467|NCT01997216|OG001|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
11170468|NCT01997216|EG000|Reported Event|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
11170469|NCT01997216|EG001|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
11170470|NCT01997229|BG000|Baseline|Eculizumab|"Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
10888057|NCT00504504|BG000|Baseline|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
10888058|NCT00504504|FG000|Participant Flow|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
10888059|NCT00504504|OG000|Outcome|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
10888060|NCT00504504|EG000|Reported Event|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
10888061|NCT00504556|BG000|Baseline|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
10888062|NCT00504556|BG001|Baseline|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
10888063|NCT00504556|BG002|Baseline|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
10888064|NCT00504556|BG003|Baseline|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
10888065|NCT00504556|BG004|Baseline|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
10888066|NCT00504556|BG005|Baseline|Total|Total of all reporting groups
10888067|NCT00504556|FG000|Participant Flow|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
10888068|NCT00504556|FG001|Participant Flow|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
10888069|NCT00504556|FG002|Participant Flow|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
10888070|NCT00504556|FG003|Participant Flow|DU-176b 60mg Bid|"DU-176b 60mg tablets two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
10888071|NCT00504556|FG004|Participant Flow|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
10888072|NCT00504556|OG000|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
11170471|NCT01997229|BG001|Baseline|Placebo|"Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
11170472|NCT01997229|BG002|Baseline|Total|Total of all reporting groups
11170473|NCT01997229|FG000|Participant Flow|Eculizumab|"Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
11170474|NCT01997229|FG001|Participant Flow|Placebo|"Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
11170475|NCT01997229|OG000|Outcome|Eculizumab|"Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
11170476|NCT01997229|OG001|Outcome|Placebo|"Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
11170477|NCT01997229|EG000|Reported Event|Eculizumab|"Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
11170478|NCT01997229|EG001|Reported Event|Placebo|"Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
11170479|NCT01997281|BG000|Baseline|DF-cereal, Then Conventional Cereal|"Dietary fiber-enriched cereal was provided with 300 mL of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 79g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg was added for dinner and breakfast~after 1 week of wash-out period, subjects were re-admitted~Conventional cereal was provided with 300 ml of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg wass added for dinner and breakfast"
11170480|NCT01997281|BG001|Baseline|Conventional Cereal, Then DF-cereal|"Conventional cereal was provided with 300 ml of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg wass added for dinner and breakfast~after 1 week of wash-out period, subjects were re-admitted~Dietary fiber-enriched cereal was provided with 300 mL of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 79g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg was added for dinner and breakfast"
10888073|NCT00504556|OG001|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
10888074|NCT00504556|OG002|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
10888075|NCT00504556|OG003|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
10888076|NCT00504556|OG004|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
10888077|NCT00504556|EG000|Reported Event|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
10888078|NCT00504556|EG001|Reported Event|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
11170481|NCT01997281|BG002|Baseline|Total|Total of all reporting groups
11170482|NCT01997281|FG000|Participant Flow|DF-cereal, Then Conventional Cereal|"Dietary fiber-enriched cereal was provided with 300 mL of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 79g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg was added for dinner and breakfast~after 1 week of wash-out period, subjects were re-admitted~Conventional cereal was provided with 300 ml of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg wass added for dinner and breakfast"
11170483|NCT01997281|FG001|Participant Flow|Conventional Cereal, Then DF-cereal|"Conventional cereal was provided with 300 ml of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg wass added for dinner and breakfast~after 1 week of wash-out period, subjects were re-admitted~Dietary fiber-enriched cereal was provided with 300 mL of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 79g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg was added for dinner and breakfast"
10888079|NCT00504556|EG002|Reported Event|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
10888080|NCT00504556|EG003|Reported Event|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
10888081|NCT00504556|EG004|Reported Event|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
10888082|NCT00504595|BG000|Baseline|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
10888083|NCT00504595|BG001|Baseline|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
10888084|NCT00504595|BG002|Baseline|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
10888085|NCT00504595|BG003|Baseline|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
10888086|NCT00504595|BG004|Baseline|Total|Total of all reporting groups
10888087|NCT00504595|FG000|Participant Flow|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
10888088|NCT00504595|FG001|Participant Flow|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
10888089|NCT00504595|FG002|Participant Flow|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
10888090|NCT00504595|FG003|Participant Flow|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
10888091|NCT00504595|OG000|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
10888092|NCT00504595|OG001|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
10888093|NCT00504595|OG000|Outcome|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis (RA) taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
10888094|NCT00504595|OG001|Outcome|Placebo Comparator: RA Patients|Patients with Rheumatoid Arthritis (RA) who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
10888095|NCT00504595|EG000|Reported Event|ACZ885 (Canakinumab): Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1.
10888096|NCT00504595|EG001|Reported Event|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
10888097|NCT00504595|EG002|Reported Event|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
10888098|NCT00504595|EG003|Reported Event|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
10888099|NCT00504660|BG000|Baseline|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
10888100|NCT00504660|BG001|Baseline|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
10888101|NCT00504660|BG002|Baseline|Total|Total of all reporting groups
10888102|NCT00504660|FG000|Participant Flow|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
11092202|NCT01537887|FG005|Participant Flow|Sequence 6|"Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.~Sequence 6 (BAC): placebo, then LY2484595, then moxifloxacin"
11170484|NCT01997281|OG000|Outcome|DF-cereal|"dietary fiber-enriched cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)~amount of cereal: 79 g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg is added for dinner and breakfast~dietary fiber-enriched cereal: - provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)~amount: 79g for dinner and breakfast, 38.5g for night snack (10 p.m.)~one serving of steamed egg is added for dinner and breakfast"
10888103|NCT00504660|FG001|Participant Flow|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
10888104|NCT00504660|OG000|Outcome|Participants With Recurrent Anaplastic Glioma|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Capecitabine 825 mg/m^2 and Celebrex 400 mg PO every 12 hours; Arm 1 Temozolomide (TMZ) 150 mg/m^2 PO daily Days 4-8 OR Arm 2 Lomustine 100 mg/m^2 PO on Day 4; Arm 2 Participants if previously received Temozolomide but not Lomustine (CCNU) receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) receive Temozolomide.
10888105|NCT00504660|OG000|Outcome|Participants With Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
10888106|NCT00504660|EG000|Reported Event|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
10888107|NCT00504660|EG001|Reported Event|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
11170485|NCT01997281|OG001|Outcome|Conventional Cereal|"conventional cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)~amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg is added for dinner and breakfast~conventional cereal: - provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)~amount: 80 g for dinner and breakfast, 40 g for night snack (10 p.m.)~one serving (40g) of steamed egg is added for dinner and breakfast"
11170486|NCT01997281|EG000|Reported Event|DF-cereal|"Dietary fiber-enriched cereal was provided with 300 mL of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 79g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg was added for dinner and breakfast"
10888108|NCT00504725|BG000|Baseline|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
10888109|NCT00504725|BG001|Baseline|Placebo|0.9 % saline bolus of equivalent volume
10888110|NCT00504725|BG002|Baseline|Total|Total of all reporting groups
10888111|NCT00504725|FG000|Participant Flow|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
10888112|NCT00504725|FG001|Participant Flow|Placebo|0.9 % saline bolus of equivalent volume
10888113|NCT00504725|OG000|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
10888114|NCT00504725|OG001|Outcome|Placebo|0.9 % saline bolus of equivalent volume
10888115|NCT00504725|EG000|Reported Event|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
10888116|NCT00504725|EG001|Reported Event|Placebo|0.9 % saline bolus of equivalent volume
10888117|NCT00504751|BG000|Baseline|Study Treatment|This is a single arm study
11170487|NCT01997281|EG001|Reported Event|Conventional Cereal|"Conventional cereal was provided with 300 ml of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.)~amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.)~one serving (40g) of steamed egg wass added for dinner and breakfast"
11170488|NCT01997333|BG000|Baseline|Capecitabine|Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
10888118|NCT00504751|FG000|Participant Flow|Study Treatment|"This is a single arm study~bortezomib, dexamethasone, ifosfamide: VIPER chemotherapy will be administered every 28 days at the following doses:~Dexamethasone 40 mg IV days 1-4~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)~Cisplatin 25 mg IV days 1-4~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)~VELCADE 1.5 mg/m2 on days 2 and 5~mesna, cisplatin, etoposide, rituximab: VIPER chemotherapy will be administered every 28 days at the following doses:~Dexamethasone 40 mg IV days 1-4~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)~Cisplatin 25 mg IV days 1-4~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)~VELCADE 1.5"
10888119|NCT00504751|OG000|Outcome|Study Treatment|This is a single arm study
10888120|NCT00504751|EG000|Reported Event|Study Treatment|This is a single arm study
10888121|NCT00504777|BG000|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV, and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
10888122|NCT00504777|FG000|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
10888123|NCT00504777|OG000|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
10888124|NCT00504777|EG000|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
11170489|NCT01997333|BG001|Baseline|CDX-011|CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
10851009|NCT02678351|EG000|Reported Event|68Ga-PSMA PET/MRI|"Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.~68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI"
10888125|NCT00504829|BG000|Baseline|LCP-AtorFen 40/100mg|study drug arm Atorvastatin 40mg and fenofibrate 100mg
11170490|NCT01997333|BG002|Baseline|Total|Total of all reporting groups
10851036|NCT02272790|OG003|Outcome|Arm C|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 21 day cycles.~Carboplatin AUC 5 IV on Day 1 of 21 day cycles."
10851037|NCT02272790|OG000|Outcome|Arm D 175 mg|"Adavosertib 175 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10888126|NCT00504829|BG001|Baseline|Atorvastatin 40mg|active control arm atorvastatin 40mg
11170491|NCT01997333|FG000|Participant Flow|Capecitabine|Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
11170492|NCT01997333|FG001|Participant Flow|CDX-011|CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
10888127|NCT00504829|BG002|Baseline|Fenofibrate 145mg|active control arm fenofibrate 145mg
10888128|NCT00504829|BG003|Baseline|Total|Total of all reporting groups
10888129|NCT00504829|FG000|Participant Flow|LCP-AtorFen 40/100mg|study drug arm Atorvastatin 40mg and fenofibrate 100mg
10888130|NCT00504829|FG001|Participant Flow|Atorvastatin 40mg|active control arm atorvastatin 40mg
10888131|NCT00504829|FG002|Participant Flow|Fenofibrate 145mg|active control arm fenofibrate 145mg
10888132|NCT00504829|OG000|Outcome|LCP-AtorFen 40/100mg|study drug arm Atorvastatin 40mg and fenofibrate 100mg
10888133|NCT00504829|OG001|Outcome|Atorvastatin 40mg|active control arm atorvastatin 40mg
10888134|NCT00504829|OG001|Outcome|Fenofibrate 145mg|active control arm fenofibrate 145mg
10888135|NCT00504829|EG000|Reported Event|LCP-AtorFen 40/100mg|study drug arm Atorvastatin 40mg and fenofibrate 100mg
10888136|NCT00504829|EG001|Reported Event|Atorvastatin 40mg|active control arm atorvastatin 40mg
10888137|NCT00504829|EG002|Reported Event|Fenofibrate 145mg|active control arm fenofibrate 145mg
10888138|NCT00504881|BG000|Baseline|Placebo|Matching Placebo tablets administered twice a day
10888139|NCT00504881|BG001|Baseline|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
10888140|NCT00504881|BG002|Baseline|Total Title|
10888141|NCT00504881|FG000|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
10888142|NCT00504881|FG001|Participant Flow|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
10888143|NCT00504881|OG000|Outcome|Placebo|Matching Placebo tablets administered twice a day
10888144|NCT00504881|OG001|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
10888145|NCT00504881|OG000|Outcome|Placebo|"Matching Placebo tablets administered twice a day~Placebo: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period"
10888146|NCT00504881|OG001|Outcome|Brivaracetam|"A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day~Brivaracetam: Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period"
10888147|NCT00504881|EG000|Reported Event|Placebo|Matching Placebo tablets administered twice a day
10888148|NCT00504881|EG001|Reported Event|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
10888149|NCT00504894|BG000|Baseline|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
10888150|NCT00504894|BG001|Baseline|Propofol|"Propofol given at 0.90 μgml-1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
10888151|NCT00504894|BG002|Baseline|Thiopental|"Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.~Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
10888152|NCT00504894|BG003|Baseline|Total|Total of all reporting groups
10888153|NCT00504894|FG000|Participant Flow|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
10888154|NCT00504894|FG001|Participant Flow|Propofol|"Propofol give at 0.90 μgml-1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
10888155|NCT00504894|FG002|Participant Flow|Thiopental|"Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.~Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
10888156|NCT00504894|OG000|Outcome|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
10888157|NCT00504894|OG001|Outcome|Propofol|"Propofol give at 0.90 μgml-1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
10888158|NCT00504894|OG002|Outcome|Thiopental|"Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.~Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
10888159|NCT00504894|EG000|Reported Event|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
10888160|NCT00504894|EG001|Reported Event|Propofol|"Propofol give at 0.90 μgml-1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
10888161|NCT00504894|EG002|Reported Event|Thiopental|"Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.~Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
10888162|NCT00505076|BG000|Baseline|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
10888163|NCT00505076|BG001|Baseline|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
10888164|NCT00505076|BG002|Baseline|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
10888165|NCT00505076|BG003|Baseline|Total|Total of all reporting groups
10888166|NCT00505076|FG000|Participant Flow|MK-0777 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
10888167|NCT00505076|FG001|Participant Flow|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
10888168|NCT00505076|FG002|Participant Flow|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
10888169|NCT00505076|OG000|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
10888170|NCT00505076|OG001|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
10888171|NCT00505076|OG002|Outcome|Placebo BID|Subjects treated with placebo tablet BID
10888172|NCT00505076|EG000|Reported Event|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
10888173|NCT00505076|EG001|Reported Event|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
10888174|NCT00505076|EG002|Reported Event|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
10888175|NCT00505284|BG000|Baseline|Placebo|
10888176|NCT00505284|BG001|Baseline|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
10888177|NCT00505284|BG002|Baseline|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
10888178|NCT00505284|BG003|Baseline|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
10888179|NCT00505284|BG004|Baseline|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
10888180|NCT00505284|BG005|Baseline|Total|Total of all reporting groups
10888181|NCT00505284|FG000|Participant Flow|Placebo|
10888182|NCT00505284|FG001|Participant Flow|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
10888183|NCT00505284|FG002|Participant Flow|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
10888184|NCT00505284|FG003|Participant Flow|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
10888185|NCT00505284|FG004|Participant Flow|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
10888186|NCT00505284|OG000|Outcome|Placebo|
10888187|NCT00505284|OG001|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
10888188|NCT00505284|OG002|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
10888189|NCT00505284|OG003|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
10888190|NCT00505284|OG004|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
10888191|NCT00505284|EG000|Reported Event|Placebo|
10888192|NCT00505284|EG001|Reported Event|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
10888193|NCT00505284|EG002|Reported Event|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
10888194|NCT00505284|EG003|Reported Event|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
10888195|NCT00505284|EG004|Reported Event|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
10888196|NCT00505362|BG000|Baseline|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
10888197|NCT00505362|BG001|Baseline|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
10888198|NCT00505362|BG002|Baseline|Total|Total of all reporting groups
10888199|NCT00505362|FG000|Participant Flow|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
10888200|NCT00505362|FG001|Participant Flow|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
10888201|NCT00505362|OG000|Outcome|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
10888202|NCT00505362|OG001|Outcome|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
10888203|NCT00505362|EG000|Reported Event|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
10888204|NCT00505362|EG001|Reported Event|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
10888205|NCT00505375|BG000|Baseline|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
10888206|NCT00505375|BG001|Baseline|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
10888207|NCT00505375|BG002|Baseline|Total|Total of all reporting groups
10888208|NCT00505375|FG000|Participant Flow|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
10888209|NCT00505375|FG001|Participant Flow|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
10888210|NCT00505375|OG000|Outcome|CTLA-4 Ig|Intravenous infusions 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
10888211|NCT00505375|OG001|Outcome|Placebo|Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
11170493|NCT01997333|OG000|Outcome|Capecitabine|Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
11170494|NCT01997333|OG001|Outcome|CDX-011|CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
11170495|NCT01997333|OG001|Outcome|CDX-011|CDX-011 administered as on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
11170496|NCT01997333|OG000|Outcome|CDX-011|CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
11170497|NCT01997333|EG000|Reported Event|Capecitabine|Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
11170498|NCT01997333|EG001|Reported Event|CDX-011|CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
11170499|NCT01997398|BG000|Baseline|DBS Under General Anesthesia|Patients with advanced Parkinson's disease who underwent bilateral globus pallidus interna (GPi) deep brain stimulation surgery under general anesthesia without the use of microelectrode recordings or intraoperative stimulation.
11170500|NCT01997398|FG000|Participant Flow|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
11170501|NCT01997398|OG000|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off  medication UPDRS III scores of patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.~Off medication ."
11170502|NCT01997398|OG001|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off medication UPDRS III scores of patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
11170503|NCT01997398|OG002|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients scheduled for bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
11170504|NCT01997398|OG003|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients who underwent bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
11170505|NCT01997398|OG000|Outcome|Pre-DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
11170506|NCT01997398|OG001|Outcome|Post - DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
11170507|NCT01997398|EG000|Reported Event|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
11170508|NCT01997411|BG000|Baseline|4 to <8 Years Old IM Glucagon Cohort|Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
11170509|NCT01997411|BG001|Baseline|4 to <8 Years Old NG Cohort|Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of nasal glucagon at two separate visits. Order of these visits was randomized.
11170510|NCT01997411|BG002|Baseline|8 to <12 Years Old IM Glucagon Cohort|Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
11170511|NCT01997411|BG003|Baseline|8 to <12 Years Old NG Cohort|Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of nasal glucagon at two separate visits. Order of these visits was randomized.
11170512|NCT01997411|BG004|Baseline|12 to <17 Years Old NG/IM Cohort|Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive either intramuscular glucagon or nasal glucagon at two separate visits. Order of these visits was randomized.
11170513|NCT01997411|BG005|Baseline|Total|Total of all reporting groups
11170514|NCT01997411|FG000|Participant Flow|4 to<8 Years Old Intramuscular (IM) Glucagon Visit|"Participants who weighed at least 25 kilograms (kg)/55 pounds (lbs) were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.~This was completed at one visit and was the only visit for this cohort."
11170515|NCT01997411|FG001|Participant Flow|4 to <8 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit|"At the first visit, a nasal glucagon (NG) dose of 2.0 milligrams (mg) for participants 4 to less than 8 years of age was administered nasally.~At the second visit, NG dose of 3.0 mg was administered nasally."
10851038|NCT02272790|OG001|Outcome|Arm D 225 mg|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10851039|NCT02272790|EG000|Reported Event|Arm A|Adavosertib 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. Gemcitabine 800 mg/m² IV on Days 1, 8, and 15 of 28 day cycles.
11089885|NCT01525641|BG000|Baseline|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
11092203|NCT01537887|OG000|Outcome|Placebo|Administered orally once daily for 10 days during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.
10851040|NCT02272790|EG001|Reported Event|Arm B|Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 28 day cycles. Paclitaxel 80 mg/m² IV on Days 1, 8, and 15 of 28 day cycles.
11092204|NCT01537887|OG001|Outcome|LY2484595|1200 milligrams (mg) LY2484595 administered orally once daily for 10 days during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.
10888212|NCT00505375|EG000|Reported Event|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
10888213|NCT00505375|EG001|Reported Event|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
10888214|NCT00505414|BG000|Baseline|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
10888215|NCT00505414|BG001|Baseline|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
10888216|NCT00505414|BG002|Baseline|Total|Total of all reporting groups
10888217|NCT00505414|FG000|Participant Flow|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
10888218|NCT00505414|FG001|Participant Flow|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
10888219|NCT00505414|FG002|Participant Flow|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
10888220|NCT00505414|FG003|Participant Flow|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg up to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
10888221|NCT00505414|FG004|Participant Flow|Morphine (Titration Phase)|After signing informed consent eligible participants were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
10888222|NCT00505414|OG000|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
10888223|NCT00505414|OG001|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
10888224|NCT00505414|OG002|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
10888225|NCT00505414|OG003|Outcome|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
10888226|NCT00505414|OG004|Outcome|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
10888227|NCT00505414|EG000|Reported Event|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
10888228|NCT00505414|EG001|Reported Event|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
10888229|NCT00505414|EG002|Reported Event|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
10888230|NCT00505414|EG003|Reported Event|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
10888231|NCT00505414|EG004|Reported Event|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
10888232|NCT00505518|BG000|Baseline|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
10888233|NCT00505518|FG000|Participant Flow|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
10888234|NCT00505518|OG000|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
10888235|NCT00505518|EG000|Reported Event|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
11092205|NCT01537887|OG000|Outcome|LY2484595|1200 milligrams (mg) LY2484595 administered orally once daily for 10 days during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.
10851041|NCT02272790|EG002|Reported Event|Arm C|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 21 day cycles.~Carboplatin AUC 5 IV on Day 1 of 21 day cycles."
11170516|NCT01997411|FG002|Participant Flow|4 to <8 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit|"At the first visit, a NG dose of 3.0 mg for participants 4 to less than 8 years of age was administered nasally.~At the second visit, a NG dose of 2.0 mg was administered nasally."
10851042|NCT02272790|EG003|Reported Event|Arm C2|Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 21 day cycles. Carboplatin AUC 5 IV on Day 1 of 21 day cycles.
10851043|NCT02272790|EG004|Reported Event|Arm D-175 mg|"Adavosertib 175 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
11170517|NCT01997411|FG003|Participant Flow|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kilograms kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg. This was completed at one visit and was the only visit for this cohort.
10888236|NCT00505622|BG000|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888237|NCT00505622|BG001|Baseline|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888238|NCT00505622|BG002|Baseline|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888239|NCT00505622|BG003|Baseline|Total|Total of all reporting groups
10888240|NCT00505622|FG000|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888241|NCT00505622|FG001|Participant Flow|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888242|NCT00505622|FG002|Participant Flow|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888243|NCT00505622|OG000|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888244|NCT00505622|OG001|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888245|NCT00505622|OG002|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888246|NCT00505622|EG000|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888247|NCT00505622|EG001|Reported Event|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888248|NCT00505622|EG002|Reported Event|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
10888249|NCT00505635|BG000|Baseline|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
10888250|NCT00505635|FG000|Participant Flow|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
10888251|NCT00505635|OG000|Outcome|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
10888252|NCT00505635|EG000|Reported Event|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
10888253|NCT00505661|BG000|Baseline|Letrozole|2.5 mg by mouth (PO) daily
10888254|NCT00505661|FG000|Participant Flow|Letrozole|2.5 mg by mouth (PO) daily
10888255|NCT00505661|OG000|Outcome|Letrozole|2.5 mg by mouth (PO) daily
10888256|NCT00505661|EG000|Reported Event|Letrozole|2.5 mg by mouth (PO) daily
10888257|NCT00505687|BG000|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
10888258|NCT00505687|FG000|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
10888259|NCT00505687|OG000|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
10888260|NCT00505687|EG000|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
10888261|NCT00505752|BG000|Baseline|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888262|NCT00505752|BG001|Baseline|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888263|NCT00505752|BG002|Baseline|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888264|NCT00505752|BG003|Baseline|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888265|NCT00505752|BG004|Baseline|Total|Total of all reporting groups
10888266|NCT00505752|FG000|Participant Flow|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888267|NCT00505752|FG001|Participant Flow|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888268|NCT00505752|FG002|Participant Flow|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
11092206|NCT01537887|EG000|Reported Event|LY2484595|1200 milligrams (mg) LY2484595 administered orally once daily for 10 days during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.
11089886|NCT01525641|FG000|Participant Flow|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
11089887|NCT01525641|OG000|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
11089888|NCT01525641|EG000|Reported Event|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
10888269|NCT00505752|FG003|Participant Flow|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888270|NCT00505752|OG000|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888271|NCT00505752|OG001|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888272|NCT00505752|OG002|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888273|NCT00505752|OG003|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888274|NCT00505752|EG000|Reported Event|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888275|NCT00505752|EG001|Reported Event|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888276|NCT00505752|EG002|Reported Event|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888277|NCT00505752|EG003|Reported Event|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
10888278|NCT00505765|BG000|Baseline|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
10888279|NCT00505765|BG001|Baseline|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
11089889|NCT01525667|BG000|Baseline|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
11089890|NCT01525667|BG001|Baseline|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
11089891|NCT01525667|BG002|Baseline|Placebo|Placebo: Single treatment, multiple injections
11089892|NCT01525667|BG003|Baseline|Total|Total of all reporting groups
11089893|NCT01525667|FG000|Participant Flow|PLX-PAD Low Dose|150M PLX-PAD : Single treatment, multiple injections
11089894|NCT01525667|FG001|Participant Flow|PLX-PAD High Dose|300M PLX-PAD : Single treatment, multiple injections
10888280|NCT00505765|BG002|Baseline|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
10888281|NCT00505765|BG003|Baseline|Total|Total of all reporting groups
10888282|NCT00505765|FG000|Participant Flow|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
10888283|NCT00505765|FG001|Participant Flow|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
10888284|NCT00505765|FG002|Participant Flow|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
10888285|NCT00505765|OG000|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
10888286|NCT00505765|OG001|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
10888287|NCT00505765|OG002|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
10888288|NCT00505765|EG000|Reported Event|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
10888289|NCT00505765|EG001|Reported Event|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
10888290|NCT00505765|EG002|Reported Event|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
10888291|NCT00505778|BG000|Baseline|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
10888292|NCT00505778|BG001|Baseline|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
10888293|NCT00505778|BG002|Baseline|Total|Total of all reporting groups
10888294|NCT00505778|FG000|Participant Flow|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
10888295|NCT00505778|FG001|Participant Flow|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
10888296|NCT00505778|OG000|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
10888297|NCT00505778|OG001|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
10888298|NCT00505778|EG000|Reported Event|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
10888299|NCT00505778|EG001|Reported Event|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
10888300|NCT00505895|BG000|Baseline|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
10888301|NCT00505895|BG001|Baseline|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5."
10888302|NCT00505895|BG002|Baseline|Total|Total of all reporting groups
10888303|NCT00505895|FG000|Participant Flow|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
10888304|NCT00505895|FG001|Participant Flow|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
10888305|NCT00505895|OG000|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
10888306|NCT00505895|OG001|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
10888307|NCT00505895|EG000|Reported Event|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
10888308|NCT00505895|EG001|Reported Event|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
10888309|NCT00505921|BG000|Baseline|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
11089895|NCT01525667|FG002|Participant Flow|Placebo|Placebo: Single treatment, multiple injections
11089896|NCT01525667|OG000|Outcome|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
11089897|NCT01525667|OG001|Outcome|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
11089898|NCT01525667|OG002|Outcome|Placebo|Placebo: Single treatment, multiple injections
11089899|NCT01525667|OG000|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
11089900|NCT01525667|OG001|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
11089901|NCT01525667|EG000|Reported Event|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
10888310|NCT00505921|FG000|Participant Flow|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
10888311|NCT00505921|OG000|Outcome|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
10888312|NCT00505921|EG000|Reported Event|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
10888313|NCT00505934|BG000|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
10888314|NCT00505934|FG000|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
10888315|NCT00505934|OG000|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
10888316|NCT00505934|EG000|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
10888317|NCT00506025|BG000|Baseline|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
10888318|NCT00506025|BG001|Baseline|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
10888319|NCT00506025|BG002|Baseline|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
10888320|NCT00506025|BG003|Baseline|Total|Total of all reporting groups
10888321|NCT00506025|FG000|Participant Flow|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
10888322|NCT00506025|FG001|Participant Flow|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
10888323|NCT00506025|FG002|Participant Flow|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
10888324|NCT00506025|OG000|Outcome|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
10888325|NCT00506025|OG001|Outcome|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
10888326|NCT00506025|OG002|Outcome|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
10888327|NCT00506025|EG000|Reported Event|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
10888328|NCT00506025|EG001|Reported Event|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
10888329|NCT00506025|EG002|Reported Event|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
10851044|NCT02272790|EG005|Reported Event|Arm D-225 mg|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10888330|NCT00506077|BG000|Baseline|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
11170518|NCT01997411|FG004|Participant Flow|8 to <12 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit|"At the first visit, a NG dose of 2.0 mg for participants 8 to less than 12 years of age was administered nasally.~At the second visit, a NG dose of 3.0 mg was administered nasally."
10888331|NCT00506077|BG001|Baseline|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
10888332|NCT00506077|BG002|Baseline|Total|Total of all reporting groups
10888333|NCT00506077|FG000|Participant Flow|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
10888334|NCT00506077|FG001|Participant Flow|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
10888335|NCT00506077|OG000|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
11089902|NCT01525667|EG001|Reported Event|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
11089903|NCT01525667|EG002|Reported Event|Placebo|Placebo: Single treatment, multiple injections
11089904|NCT01525849|BG000|Baseline|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
11089905|NCT01525849|BG001|Baseline|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
11089906|NCT01525849|BG002|Baseline|Total|Total of all reporting groups
11089907|NCT01525849|FG000|Participant Flow|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
11089908|NCT01525849|FG001|Participant Flow|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
11089909|NCT01525849|OG000|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
11089910|NCT01525849|OG001|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
11089911|NCT01525849|EG000|Reported Event|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
11089912|NCT01525849|EG001|Reported Event|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
11089913|NCT01525862|BG000|Baseline|Balloon Sinus Dilation|"Balloon dilation of the maxillary sinus using a transnasal approach.~Balloon sinus dilation"
11089914|NCT01525862|FG000|Participant Flow|Balloon Sinus Dilation|"Balloon dilation of the maxillary sinus using a transnasal approach.~Balloon sinus dilation"
11089915|NCT01525862|OG000|Outcome|Balloon Sinus Dilation|"Balloon dilation of the maxillary sinus using a transnasal approach.~Balloon sinus dilation"
11089916|NCT01525862|EG000|Reported Event|Balloon Sinus Dilation|"Balloon dilation of the maxillary sinus using a transnasal approach.~Balloon sinus dilation"
11089917|NCT01525875|BG000|Baseline|Magnesium Oxide|Magnesium oxide capsules 800mg twice daily (total of 1000mg of elemental magnesium) for year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
11089918|NCT01525875|BG001|Baseline|Placebo|Placebo year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
11089919|NCT01525875|BG002|Baseline|Total|Total of all reporting groups
11089920|NCT01525875|FG000|Participant Flow|Magnesium Oxide|Magnesium oxide capsules 800mg twice daily (total of 1000mg of elemental magnesium) for year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
11089921|NCT01525875|FG001|Participant Flow|Placebo|Placebo year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
11089922|NCT01525875|OG000|Outcome|Magnesium Oxide|Magnesium oxide capsules 800mg twice daily (total of 1000mg of elemental magnesium) for year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
11089923|NCT01525875|OG001|Outcome|Placebo|Placebo year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
11089924|NCT01525875|EG000|Reported Event|Magnesium Oxide|Magnesium oxide capsules 800mg twice daily (total of 1000mg of elemental magnesium) for year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
11233034|NCT02423447|FG000|Participant Flow|Electro-Flo, Then G5|"The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2.~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
11233035|NCT02423447|FG001|Participant Flow|G5, Then Electro-Flo|"The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
11233036|NCT02423447|OG000|Outcome|ElectroFlo Arm|ElectroFlo Arm
11233037|NCT02423447|OG001|Outcome|G5 Flimm Fighter Arm|G5 Flimm Fighter arm
11233038|NCT02423447|OG000|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
11170519|NCT01997411|FG005|Participant Flow|8 to <12 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit|"At the first visit, a NG dose of 3.0 mg for participants 8 to less than 12 years of age was administered nasally.~At the second visit, a NG dose of 2.0 mg was administered nasally."
11170520|NCT01997411|FG006|Participant Flow|12 to <17 Years Old NG 1st Visit/IM Glucagon 2nd Visit|"At the first visit, a NG dose of 3.0 mg was administered nasally.~At the second visit, participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg."
11170521|NCT01997411|FG007|Participant Flow|12 to <17 Years Old IM Glucagon 1st Visit/NG 2nd Visit|"At the first visit, participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.~At the second visit, a NG dose of 3.0 mg was administered nasally."
11170522|NCT01997411|OG000|Outcome|4 to<8 Years Old IM Glucagon Visit|Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
11170523|NCT01997411|OG001|Outcome|4 to<8 Years Old NG Visit 2.0 mg|NG dose of 2.0 mg for participants 4 to less than 8 years of age.
11170524|NCT01997411|OG002|Outcome|4 to<8 Years Old NG Visit 3.0 mg|NG dose of 3.0 mg for participants 4 to less than 8 years of age.
11170525|NCT01997411|OG003|Outcome|8 to <12 Years Old IM Glucagon Visit|Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
11170526|NCT01997411|OG004|Outcome|8 to<12 Years Old NG Visit 2.0 mg|NG dose of 2.0 mg for participants 8 to less than 12 years of age.
11170527|NCT01997411|OG005|Outcome|8 to<12 Years Old NG Visit 3.0 mg|NG dose of 3.0 mg for participants 8 to less than 12 years of age.
11170528|NCT01997411|OG006|Outcome|12 to <17 Years Old IM Glucagon Visit|Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
11170529|NCT01997411|OG007|Outcome|12 to<17 Years Old NG Visit 3.0 mg|NG dose of 3.0 mg for participants 12 to less than 17 years of age.
11170530|NCT01997411|EG000|Reported Event|4 to<8 Years Old IM Glucagon Visit|Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
11170531|NCT01997411|EG001|Reported Event|4 to<8 Years Old NG Visit 2.0 mg|NG dose of 2.0 mg for participants 4 to less than 8 years of age.
11170532|NCT01997411|EG002|Reported Event|4 to<8 Years Old NG Visit 3.0 mg|NG dose of 3.0 mg for participants 4 to less than 8 years of age.
11170533|NCT01997411|EG003|Reported Event|8 to <12 Years Old IM Glucagon Visit|Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
11170534|NCT01997411|EG004|Reported Event|8 to<12 Years Old NG Visit 2.0 mg|NG of 2.0 mg for participants 8 to less than 12 years of age.
11170535|NCT01997411|EG005|Reported Event|8 to<12 Years Old NG Visit 3.0 mg|NG dose of 3.0 mg for participants 8 to less than 12 years of age.
11170536|NCT01997411|EG006|Reported Event|12 to <17 Years Old IM Glucagon Visit|Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
11170537|NCT01997411|EG007|Reported Event|12 to<17 Years Old NG Visit 3.0 mg|NG dose of 3.0 mg for participants 12 to less than 17 years of age.
11170538|NCT01997437|BG000|Baseline|Tissue-engineered Airway Transplantation|"Stem-cell seeded bioartificial tracheal scaffold~Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ"
11170539|NCT01997437|FG000|Participant Flow|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
11170540|NCT01997437|OG000|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
11170541|NCT01997437|EG000|Reported Event|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
11170542|NCT01997515|BG000|Baseline|Group K (Ketamine)|Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
11170543|NCT01997515|BG001|Baseline|Group P (Placebo)|Group P (placebo) will receive the same amount of saline.
11170544|NCT01997515|BG002|Baseline|Total|Total of all reporting groups
11170545|NCT01997515|FG000|Participant Flow|Group K (Ketamine)|Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
11170546|NCT01997515|FG001|Participant Flow|Group P (Placebo)|Group P (placebo) will receive the same amount of saline.
11170547|NCT01997515|OG000|Outcome|Group K (Ketamine)|Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
11170548|NCT01997515|OG001|Outcome|Group P (Placebo)|Group P (placebo) will receive the same amount of saline.
11170549|NCT01997515|EG000|Reported Event|Group K (Ketamine)|Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
11170550|NCT01997515|EG001|Reported Event|Group P (Placebo)|Group P (placebo) will receive the same amount of saline.
10851045|NCT01961531|BG000|Baseline|Accuboost APBI|"28Gy delivered in 5 daily fractions~Accuboost APBI: 28Gy delivered in 5 daily fractions"
11170551|NCT01997723|BG000|Baseline|OSA Testing|"Cross-over design, single group/arm~Interventions:~One polysomnography one laboratory Portable monitoring simultaneously with polysomnography one home Portable monitoring"
10851046|NCT01961531|FG000|Participant Flow|Accuboost APBI|"28Gy delivered in 5 daily fractions~Accuboost APBI: 28Gy delivered in 5 daily fractions"
10851047|NCT01961531|OG000|Outcome|Accuboost APBI|"28Gy delivered in 5 daily fractions~Accuboost APBI: 28Gy delivered in 5 daily fractions"
10888336|NCT00506077|OG001|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
10888337|NCT00506077|EG000|Reported Event|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
11170552|NCT01997723|FG000|Participant Flow|Experimental|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
11170553|NCT01997723|OG000|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
11170554|NCT01997723|EG000|Reported Event|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
11170555|NCT01997892|BG000|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
11170556|NCT01997892|FG000|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEGylated (PEG) epoetin beta immediately prior to being switched to darbepoetin alfa.
11170557|NCT01997892|OG000|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
11170558|NCT01997892|OG000|Outcome|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
11170559|NCT01997892|OG001|Outcome|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
10888338|NCT00506077|EG001|Reported Event|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
11170560|NCT01997892|OG000|Outcome|Excursions <10.0 g/dL|Hemoglobin excursions below 10.0 g/dL
11170561|NCT01997892|OG001|Outcome|Excursions > 12.0 g/dL|Hemoglobin excursions above 12.0 g/dL
11170562|NCT01997892|EG000|Reported Event|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
11170563|NCT01997892|EG001|Reported Event|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
11170564|NCT01997905|BG000|Baseline|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
11170565|NCT01997905|FG000|Participant Flow|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
11170566|NCT01997905|OG000|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
11170567|NCT01997905|EG000|Reported Event|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
11170568|NCT01998243|BG000|Baseline|Group B|this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
11170569|NCT01998243|BG001|Baseline|Intragastrc Balloon (IGB) Group A|"this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation~preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems"
11170570|NCT01998243|BG002|Baseline|Total|Total of all reporting groups
11170571|NCT01998243|FG000|Participant Flow|Group B|42 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
11170572|NCT01998243|FG001|Participant Flow|IGB-BIB® Group A|"39 patients included have a preoperative intragastric balloon during a period of 6 months before operation~preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems"
11170573|NCT01998243|OG000|Outcome|Group B|this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
10888339|NCT00506129|BG000|Baseline|Fludarabine + Melphalan With PBPC|Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
10888340|NCT00506129|FG000|Participant Flow|Fludarabine + Melphalan With PBPC|Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
11233039|NCT02423447|OG001|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
11233040|NCT02423447|OG000|Outcome|Electro-Flo Arm|Electro-Flo arm Electro-Flo device following the 2012 CFF therapy guidelines
10851048|NCT01961531|EG000|Reported Event|Accuboost APBI|"28Gy delivered in 5 daily fractions~Accuboost APBI: 28Gy delivered in 5 daily fractions"
10851049|NCT01880541|BG000|Baseline|Hypnosedation|"hypnosedation~hypnosedation: hypnosedation"
10851050|NCT01880541|BG001|Baseline|General Anesthesia|"general anesthesia~general anesthésia: general anesthesia"
11233041|NCT02423447|EG000|Reported Event|Electro Flo|Electro flo
11233042|NCT02423447|EG001|Reported Event|G5 Flimm Fighter|G5 Flimm Fighter
11233043|NCT02423577|BG000|Baseline|FF-3 Dry Powder|"FF-3~FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
11233044|NCT02423577|BG001|Baseline|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
11233045|NCT02423577|BG002|Baseline|Total|Total of all reporting groups
10851051|NCT01880541|BG002|Baseline|Total|Total of all reporting groups
10851052|NCT01880541|FG000|Participant Flow|Hypnosedation|"hypnosedation~hypnosedation: hypnosedation"
10851053|NCT01880541|FG001|Participant Flow|General Anesthesia|"general anesthesia~general anesthésia: general anesthesia"
10851054|NCT01880541|OG000|Outcome|Hypnosedation|"hypnosedation~hypnosedation: hypnosedation"
10851055|NCT01880541|OG001|Outcome|General Anesthesia|"general anesthesia~general anesthésia: general anesthesia"
10851056|NCT01880541|EG000|Reported Event|Hypnosedation|"hypnosedation~hypnosedation: hypnosedation"
10851057|NCT01880541|EG001|Reported Event|General Anesthesia|"general anesthesia~general anesthésia: general anesthesia"
10851058|NCT01693692|BG000|Baseline|Placebo|Participants will be administered a placebo once daily for 6 weeks.
10851059|NCT01693692|BG001|Baseline|TD-9855 Group 1|Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
10851060|NCT01693692|BG002|Baseline|TD-9855 Group 2|Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
10851061|NCT01693692|BG003|Baseline|Total|Total of all reporting groups
10851062|NCT01693692|FG000|Participant Flow|Placebo|Participants will be administered a placebo once daily for 6 weeks.
10851063|NCT01693692|FG001|Participant Flow|TD-9855 Group 1|Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
10851064|NCT01693692|FG002|Participant Flow|TD-9855 Group 2|Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
10851065|NCT01693692|OG000|Outcome|Placebo|Participants will be administered a placebo once daily for 6 weeks.
10851066|NCT01693692|OG001|Outcome|TD-9855 Group 1|Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
10851067|NCT01693692|OG002|Outcome|TD-9855 Group 2|Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
10851068|NCT01693692|EG000|Reported Event|Placebo|Participants will be administered a placebo once daily for 6 weeks.
10851069|NCT01693692|EG001|Reported Event|TD-9855 Group 1|Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
10851070|NCT01693692|EG002|Reported Event|TD-9855 Group 2|Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
10851071|NCT01685606|BG000|Baseline|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
10851072|NCT01685606|FG000|Participant Flow|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
10851073|NCT01685606|OG000|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
10851074|NCT01685606|EG000|Reported Event|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
10851075|NCT01650350|BG000|Baseline|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
10851076|NCT01650350|FG000|Participant Flow|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
10851077|NCT01650350|OG000|Outcome|Melanoma: Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
10851078|NCT01650350|OG001|Outcome|Prostate Cancer- Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
10851079|NCT01650350|OG000|Outcome|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
10888341|NCT00506129|OG000|Outcome|Fludarabine + Melphalan With PBPC|Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
10888342|NCT00506129|EG000|Reported Event|Fludarabine + Melphalan With PBPC|Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
10888343|NCT00506142|BG000|Baseline|Cohort 1|"Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week."
10888344|NCT00506142|BG001|Baseline|Cohort 2|"Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week~Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week."
10888345|NCT00506142|BG002|Baseline|Total|Total of all reporting groups
10888346|NCT00506142|FG000|Participant Flow|Cohort 1|Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
11170574|NCT01998243|OG001|Outcome|IGB Group A|"this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation~preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems"
11170575|NCT01998243|OG000|Outcome|Group B|34 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
11170576|NCT01998243|OG001|Outcome|IGB Group A|"32 patients included have a preoperative intragastric balloon during a period of 6 months before operation~preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems"
11170577|NCT01998243|EG000|Reported Event|Group B|34 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
11170578|NCT01998243|EG001|Reported Event|IGB Group A|"32 patients included have a preoperative intragastric balloon during a period of 6 months before operation~preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems"
11170579|NCT01998269|BG000|Baseline|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a scale.
11233046|NCT02423577|FG000|Participant Flow|FF-3 Dry Powder|"FF-3~FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
11233047|NCT02423577|FG001|Participant Flow|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
11233048|NCT02423577|OG000|Outcome|FF-3 Dry Powder|"FF-3~FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
10888347|NCT00506142|FG001|Participant Flow|Cohort 2|Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
10888348|NCT00506142|OG000|Outcome|Cohort 1|"Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week."
10888349|NCT00506142|OG001|Outcome|Cohort 2|"Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week~Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week."
10888350|NCT00506142|EG000|Reported Event|Cohort 1|"Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week."
10888351|NCT00506142|EG001|Reported Event|Cohort 2|"Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week~Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.~Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week."
10888352|NCT00506155|BG000|Baseline|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
10888353|NCT00506155|FG000|Participant Flow|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
10888354|NCT00506155|OG000|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
11233049|NCT02423577|OG001|Outcome|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
11233050|NCT02423577|EG000|Reported Event|FF-3 Dry Powder|"FF-3~FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
11233051|NCT02423577|EG001|Reported Event|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
10851080|NCT01650350|EG000|Reported Event|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
11233052|NCT02423798|BG000|Baseline|All Subjects|All Subjects
11233053|NCT02423798|FG000|Participant Flow|All Subjects|All subjects will receive identical devices and undergo the same experimental procedures.
11233054|NCT02423798|OG000|Outcome|All Subjects|All Subjects
11233055|NCT02423798|OG000|Outcome|All Subjects|
11233056|NCT02423798|EG000|Reported Event|All Subjects|
11233057|NCT02423980|BG000|Baseline|G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg|A 1 mg dose of G-Pen was given at an initial clinic visit. After a 1-2 week wash-out, subjects received a 0.5 mg dose of G-Pen™ at a second visit.
11233058|NCT02423980|FG000|Participant Flow|G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg|A 1 mg dose of glucagon at an initial clinic visit, followed by a 0.5 mg dose of glucagon given at a subsequent clinic visit after a 1-2 week wash-out.
11233059|NCT02423980|OG000|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
11233060|NCT02423980|OG001|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
11233061|NCT02423980|EG000|Reported Event|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
11233062|NCT02423980|EG001|Reported Event|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
10888355|NCT00506155|EG000|Reported Event|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
10888356|NCT00506285|BG000|Baseline|a) Methylphenidate Transdermal System Was Taken First|Subjects took Methylphenidate Transdermal System in the first treatment arm and placebo patch in the second treatment arm
10888357|NCT00506285|BG001|Baseline|B Placebo Patch Was Used First|Placebo patch was used in the first treatment arm and MTS in the second treatment arm.
10888358|NCT00506285|BG002|Baseline|Total|Total of all reporting groups
10888359|NCT00506285|FG000|Participant Flow|A) MTS Arm Was 1st and PBO Arm Was 2nd|MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
10888360|NCT00506285|FG001|Participant Flow|B) PBO Arm Was 1st and MTS Arm Was 2nd|Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
10888361|NCT00506285|OG000|Outcome|Scores in MTS Arm|Average WRAADDS scores at end of active treatment (MTS) arm
10888362|NCT00506285|OG001|Outcome|Scores in Placebo Arm|Average WRAADDS scores at end of placebo arm
10888363|NCT00506285|OG000|Outcome|Scores in MTS Arm|Average CAARS score at end of active treatment
11089925|NCT01525875|EG001|Reported Event|Placebo|Placebo year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
11089926|NCT01526057|BG000|Baseline|Rituximab-Pfizer|Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089927|NCT01526057|BG001|Baseline|Rituximab-EU|Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089928|NCT01526057|BG002|Baseline|Rituximab-US|Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089929|NCT01526057|BG003|Baseline|Total|Total of all reporting groups
11089930|NCT01526057|FG000|Participant Flow|Rituximab-Pfizer|Participants received intravenous (IV) rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 milligram [mg] methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg per week (mg/week) (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089931|NCT01526057|FG001|Participant Flow|Rituximab-European Union (EU)|Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11092207|NCT01537887|EG001|Reported Event|Placebo|Administered orally once daily for 10 days during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.
10888364|NCT00506285|OG001|Outcome|Scores in Placebo Arm|Average CAARS score at end of placebo treatment
10888365|NCT00506285|EG000|Reported Event|MTS Arm|Adverse events and Serious AEs during active treatment (MTS) arm
10888366|NCT00506285|EG001|Reported Event|Placebo Arm|Adverse events and Serious AEs during placebo arm
10888367|NCT00506350|BG000|Baseline|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10888368|NCT00506350|BG001|Baseline|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888369|NCT00506350|BG002|Baseline|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888370|NCT00506350|BG003|Baseline|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888371|NCT00506350|BG004|Baseline|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888372|NCT00506350|BG005|Baseline|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888373|NCT00506350|BG006|Baseline|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888374|NCT00506350|BG007|Baseline|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888375|NCT00506350|BG008|Baseline|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888376|NCT00506350|BG009|Baseline|Total|Total of all reporting groups
10888377|NCT00506350|FG000|Participant Flow|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10888378|NCT00506350|FG001|Participant Flow|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888379|NCT00506350|FG002|Participant Flow|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888380|NCT00506350|FG003|Participant Flow|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888381|NCT00506350|FG004|Participant Flow|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888382|NCT00506350|FG005|Participant Flow|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888383|NCT00506350|FG006|Participant Flow|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888384|NCT00506350|FG007|Participant Flow|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888385|NCT00506350|FG008|Participant Flow|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888386|NCT00506350|OG000|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
11233063|NCT02423993|BG000|Baseline|SAP + Group Education|"All patients will be transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.~We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
11233064|NCT02423993|BG001|Baseline|SAP + Standart Education|Patients will be transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM will be used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received
11233065|NCT02423993|BG002|Baseline|CSII + Group Education|"Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.~We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
11233066|NCT02423993|BG003|Baseline|CSII + Standart Education|Patients will be transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by HbA1c. The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
11233067|NCT02423993|BG004|Baseline|Total|Total of all reporting groups
11233068|NCT02423993|FG000|Participant Flow|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
11233069|NCT02423993|FG001|Participant Flow|SAP + Standart Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
11233070|NCT02423993|FG002|Participant Flow|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
10851081|NCT01650285|BG000|Baseline|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
11089932|NCT01526057|FG002|Participant Flow|Rituximab-US|Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089933|NCT01526057|OG000|Outcome|Rituximab-Pfizer|Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089934|NCT01526057|OG001|Outcome|Rituximab-EU|Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089935|NCT01526057|OG002|Outcome|Rituximab-US|Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089936|NCT01526057|EG000|Reported Event|Rituximab-Pfizer|Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089937|NCT01526057|EG001|Reported Event|Rituximab-EU|Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089938|NCT01526057|EG002|Reported Event|Rituximab-US|Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
11089939|NCT01526148|BG000|Baseline|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
11089940|NCT01526148|BG001|Baseline|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
11089941|NCT01526148|BG002|Baseline|Total|Total of all reporting groups
11089942|NCT01526148|FG000|Participant Flow|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
11089943|NCT01526148|FG001|Participant Flow|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
11089944|NCT01526148|OG000|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
11089945|NCT01526148|OG001|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
11089946|NCT01526148|EG000|Reported Event|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
11089947|NCT01526148|EG001|Reported Event|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
11089948|NCT01526213|BG000|Baseline|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11089949|NCT01526213|BG001|Baseline|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11089950|NCT01526213|BG002|Baseline|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11092208|NCT01537887|EG002|Reported Event|Moxifloxacin|400 mg Moxifloxacin: Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods. There was at least 14 days washout between consecutive dosing periods.
10888387|NCT00506350|OG001|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888388|NCT00506350|OG002|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888389|NCT00506350|OG003|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888390|NCT00506350|OG000|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10888391|NCT00506350|OG001|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888392|NCT00506350|OG002|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888393|NCT00506350|OG003|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888394|NCT00506350|OG004|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
11092209|NCT01537900|BG000|Baseline|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
11092210|NCT01537900|FG000|Participant Flow|Grazoprevir 100 mg|Participants received GZR 100 mg once daily (q.d.) for 7 days. Liver FNA was performed on Day 7.
11092211|NCT01537900|OG000|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
11092212|NCT01537900|EG000|Reported Event|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
11092213|NCT01537926|BG000|Baseline|N-acetylcysteine (NAC)|"N-acetylcysteine 600mg by mouth every 12 hours for 90 days. N-acetylcysteine 1200mg by mouth every 12 hours for 270 days~N-acetylcysteine: NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days."
11092214|NCT01537926|BG001|Baseline|Placebo|"Placebo 1 cap by mouth every 12 hours for 90 days. Placebo 2 caps by mouth every 12 hours for 270 days.~Placebo: sugar pill manufactured to minic NAC 600mg capsule"
11092215|NCT01537926|BG002|Baseline|Total|Total of all reporting groups
11092216|NCT01537926|FG000|Participant Flow|N-acetylcysteine (NAC)|"N-acetylcysteine (NAC) 600mg by mouth every 12 hours for 90 days. N-acetylcysteine 1200mg by mouth every 12 hours for 270 days~N-acetylcysteine: NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days."
11092217|NCT01537926|FG001|Participant Flow|Placebo|"Placebo 1 cap by mouth every 12 hours for 90 days. Placebo 2 caps by mouth every 12 hours for 270 days.~Placebo: sugar pill manufactured to minic NAC 600mg capsule"
11092218|NCT01537926|OG000|Outcome|N-acetylcysteine (NAC)|"N-acetylcysteine 600mg by mouth every 12 hours for 90 days. N-acetylcysteine 1200mg by mouth every 12 hours for 270 days~N-acetylcysteine: NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days."
11092219|NCT01537926|OG001|Outcome|Placebo|"Placebo 1 cap by mouth every 12 hours for 90 days. Placebo 2 caps by mouth every 12 hours for 270 days.~Placebo: sugar pill manufactured to mimic NAC 600mg capsule"
11092220|NCT01537926|OG000|Outcome|All Participants|"N-acetylcysteine: NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days.~OR~Placebo: sugar pill manufactured to mimic NAC 600mg capsule"
11092221|NCT01537926|EG000|Reported Event|N-acetylcysteine (NAC)|"N-acetylcysteine 600mg by mouth every 12 hours for 90 days. N-acetylcysteine 1200mg by mouth every 12 hours for 270 days~N-acetylcysteine: NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days."
11092222|NCT01537926|EG001|Reported Event|Placebo|"Placebo 1 cap by mouth every 12 hours for 90 days. Placebo 2 caps by mouth every 12 hours for 270 days.~N-acetylcysteine: NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days.~Placebo: sugar pill manufactured to mimic NAC 600mg capsule"
11089951|NCT01526213|BG003|Baseline|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11089952|NCT01526213|BG004|Baseline|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11089953|NCT01526213|BG005|Baseline|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11089954|NCT01526213|BG006|Baseline|Total|Total of all reporting groups
11089955|NCT01526213|FG000|Participant Flow|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
11089956|NCT01526213|FG001|Participant Flow|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
11089957|NCT01526213|FG002|Participant Flow|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
11089958|NCT01526213|FG003|Participant Flow|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
11089959|NCT01526213|FG004|Participant Flow|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
11089960|NCT01526213|FG005|Participant Flow|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
11089961|NCT01526213|OG000|Outcome|Water|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
11089962|NCT01526213|OG001|Outcome|Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
11089963|NCT01526213|OG002|Outcome|Furanocoumarin-free Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
11089964|NCT01526213|EG000|Reported Event|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11089965|NCT01526213|EG001|Reported Event|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11089966|NCT01526213|EG002|Reported Event|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11170580|NCT01998269|FG000|Participant Flow|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension. There are no study arms - this was a cross-sectional study to develop and validate a measure of medication self-management skills. A total of 210 patients were recruited. 17 participated in focus groups to help develop the tool. The other 193 participated in item performance testing. The results of item performance testing are reported here.
10888395|NCT00506350|OG005|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888396|NCT00506350|OG006|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888397|NCT00506350|OG007|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888398|NCT00506350|OG008|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888399|NCT00506350|OG001|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888400|NCT00506350|OG002|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888401|NCT00506350|OG001|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10888402|NCT00506350|EG000|Reported Event|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10888403|NCT00506350|EG001|Reported Event|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888404|NCT00506350|EG002|Reported Event|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888405|NCT00506350|EG003|Reported Event|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888406|NCT00506350|EG004|Reported Event|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
10888407|NCT00506350|EG005|Reported Event|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888408|NCT00506350|EG006|Reported Event|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
11089967|NCT01526213|EG003|Reported Event|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11170581|NCT01998269|OG000|Outcome|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension were enrolled in the study. There are no study arms.
11170582|NCT01998269|EG000|Reported Event|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a medication self-management scale.
11335578|NCT03552757|OG000|Outcome|Semaglutide 1.0 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11335579|NCT03552757|OG001|Outcome|Semaglutide 2.4 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11233071|NCT02423993|FG003|Participant Flow|CSII + Standart Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
11233072|NCT02423993|OG000|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
11233073|NCT02423993|OG001|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
11233074|NCT02423993|OG002|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
11233075|NCT02423993|OG003|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
10888409|NCT00506350|EG007|Reported Event|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
10888410|NCT00506350|EG008|Reported Event|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
11170583|NCT01998360|BG000|Baseline|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
11170584|NCT01998360|BG001|Baseline|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
11170585|NCT01998360|BG002|Baseline|Total|Total of all reporting groups
11170586|NCT01998360|FG000|Participant Flow|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
11170587|NCT01998360|FG001|Participant Flow|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
11170588|NCT01998360|OG000|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
11170589|NCT01998360|OG001|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
11170590|NCT01998360|EG000|Reported Event|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
11170591|NCT01998360|EG001|Reported Event|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
11170592|NCT01998399|BG000|Baseline|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
11170593|NCT01998399|BG001|Baseline|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
11170594|NCT01998399|BG002|Baseline|Total|Total of all reporting groups
11170595|NCT01998399|FG000|Participant Flow|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
11170596|NCT01998399|FG001|Participant Flow|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
11170597|NCT01998399|OG000|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
11170598|NCT01998399|OG001|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
11170599|NCT01998399|EG000|Reported Event|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
11170600|NCT01998399|EG001|Reported Event|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
11170601|NCT01998438|BG000|Baseline|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170602|NCT01998438|BG001|Baseline|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170603|NCT01998438|BG002|Baseline|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170604|NCT01998438|BG003|Baseline|Total|Total of all reporting groups
11170605|NCT01998438|FG000|Participant Flow|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170606|NCT01998438|FG001|Participant Flow|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170607|NCT01998438|FG002|Participant Flow|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170608|NCT01998438|OG000|Outcome|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11233076|NCT02423993|EG000|Reported Event|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
11233077|NCT02423993|EG001|Reported Event|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
11233078|NCT02423993|EG002|Reported Event|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
11233079|NCT02423993|EG003|Reported Event|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
11233080|NCT02424097|BG000|Baseline|MI Paste & MI Varnish|"MI past will be applied by the patient every night; MI varnish will be applied every three months in the office~CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste: MI Paste & MI Varnish- in-office:~varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)~- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray"
11233081|NCT02424097|BG001|Baseline|Standard of Care|"Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended~1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)"
11233082|NCT02424097|BG002|Baseline|Total|Total of all reporting groups
11233083|NCT02424097|FG000|Participant Flow|MI Paste & MI Varnish|"MI past will be applied by the patient every night; MI varnish will be applied every three months in the office~CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste: MI Paste & MI Varnish- in-office:~varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)~- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray"
11233084|NCT02424097|FG001|Participant Flow|Standard of Care|"Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended~1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)"
11233085|NCT02424097|OG000|Outcome|MI Paste & MI Varnish|"MI past will be applied by the patient every night; MI varnish will be applied every three months in the office~CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste: MI Paste & MI Varnish- in-office:~varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)~- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray"
11233086|NCT02424097|OG001|Outcome|Standard of Care|"Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended~1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)"
11335580|NCT03552757|OG002|Outcome|Placebo|Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
11170609|NCT01998438|OG001|Outcome|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170610|NCT01998438|OG002|Outcome|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170611|NCT01998438|EG000|Reported Event|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170612|NCT01998438|EG001|Reported Event|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170613|NCT01998438|EG002|Reported Event|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
11170614|NCT01998477|BG000|Baseline|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170615|NCT01998477|BG001|Baseline|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170616|NCT01998477|BG002|Baseline|Total|Total of all reporting groups
11170617|NCT01998477|FG000|Participant Flow|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170618|NCT01998477|FG001|Participant Flow|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170619|NCT01998477|OG000|Outcome|TIVc _inj 1 (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170620|NCT01998477|OG001|Outcome|TIVc_inj 2 (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170621|NCT01998477|OG002|Outcome|TIV_inj 1 (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170622|NCT01998477|OG003|Outcome|TIV_inj 2 (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170623|NCT01998477|OG000|Outcome|TIVc_Non naive_inj 1 (3 to <6 Years)|Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170624|NCT01998477|OG001|Outcome|TIVc_naive_inj 1 (3 to <6 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170625|NCT01998477|OG002|Outcome|TIVc_naive_inj 2 (3 to <6 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170626|NCT01998477|OG003|Outcome|TIV_Non naive_inj 1 (3 to <6 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170627|NCT01998477|OG004|Outcome|TIV_naive_inj 1 (3 to <6 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170628|NCT01998477|OG005|Outcome|TIV_naive_inj 2 (3 to <6 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170629|NCT01998477|OG006|Outcome|TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)|Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170630|NCT01998477|OG007|Outcome|TIVc_Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170631|NCT01998477|OG008|Outcome|TIVc_Naive_inj 2 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170632|NCT01998477|OG009|Outcome|TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170633|NCT01998477|OG010|Outcome|TIV_Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170634|NCT01998477|OG011|Outcome|TIV_Naive_inj 2 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170635|NCT01998477|OG012|Outcome|TIVc_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170636|NCT01998477|OG013|Outcome|TIV_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170637|NCT01998477|OG000|Outcome|TIVc (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170638|NCT01998477|OG001|Outcome|TIV (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170639|NCT01998477|OG002|Outcome|TIVc_Naive (3 to <9 Years)|Vaccine naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170640|NCT01998477|OG003|Outcome|TIVc_Non Naive (3 to <9 Years)|Vaccine non naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170641|NCT01998477|OG004|Outcome|TIVc_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
11170642|NCT01998477|OG005|Outcome|TIV_Naive (3 to <9 Years)|Vaccine naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170643|NCT01998477|OG006|Outcome|TIV_Non Naive (3 to <9 Years)|Vaccine non naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
10888411|NCT00506389|BG000|Baseline|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888412|NCT00506389|BG001|Baseline|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888413|NCT00506389|BG002|Baseline|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888414|NCT00506389|BG003|Baseline|Total|Total of all reporting groups
11233087|NCT02424097|EG000|Reported Event|MI Paste & MI Varnish|"MI past will be applied by the patient every night; MI varnish will be applied every three months in the office~CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste: MI Paste & MI Varnish- in-office:~varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)~- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray"
11233088|NCT02424097|EG001|Reported Event|Standard of Care|"Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended~1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)"
11233089|NCT02424149|BG000|Baseline|Control|No preoperative phenazopyridine
11233090|NCT02424149|BG001|Baseline|Phenazopyridine|Preoperative phenazopyridine
11233091|NCT02424149|BG002|Baseline|Total|Total of all reporting groups
11233092|NCT02424149|FG000|Participant Flow|Control|No preoperative phenazopyridine
11233093|NCT02424149|FG001|Participant Flow|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
11233094|NCT02424149|OG000|Outcome|Control|No preoperative phenazopyridine
11233095|NCT02424149|OG001|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
11233096|NCT02424149|EG000|Reported Event|Control|No preoperative phenazopyridine
11233097|NCT02424149|EG001|Reported Event|Phenazopyridine|Preoperative phenazopyridine
11233098|NCT02424175|BG000|Baseline|Patients With PSC|"This is an open label study. All patients enrolled will receive a fecal microbiota transplantation.~Fecal Microbiota Transplantation"
11233099|NCT02424175|FG000|Participant Flow|Patients With PSC|"This is an open label study. All patients enrolled will receive a fecal microbiota transplantation.~Fecal Microbiota Transplantation"
11233100|NCT02424175|OG000|Outcome|Patients With PSC|"This is an open label study. All patients enrolled will receive a fecal microbiota transplantation.~Fecal Microbiota Transplantation"
11233101|NCT02424175|EG000|Reported Event|Patients With PSC|"This is an open label study. All patients enrolled will receive a fecal microbiota transplantation.~Fecal Microbiota Transplantation"
11233102|NCT02424253|BG000|Baseline|ZPL-3893787|30 mg ZPL-3893787 orally once daily for 8 weeks.
11233103|NCT02424253|BG001|Baseline|Placebo|1 capsule orally once daily for 8 weeks.
11233104|NCT02424253|BG002|Baseline|Total|Total of all reporting groups
10888415|NCT00506389|FG000|Participant Flow|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888416|NCT00506389|FG001|Participant Flow|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888417|NCT00506389|FG002|Participant Flow|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888418|NCT00506389|OG000|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888419|NCT00506389|OG001|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888420|NCT00506389|OG002|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
10888421|NCT00506389|EG000|Reported Event|Esmirtazapine 3.0 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
11233105|NCT02424253|FG000|Participant Flow|ZPL-3893787|30 mg ZPL-3893787 orally once daily for 8 weeks.
11233106|NCT02424253|FG001|Participant Flow|Placebo|1 capsule orally once daily for 8 weeks.
11233107|NCT02424253|OG000|Outcome|ZPL-3893787|30 mg ZPL-3893787 orally once daily for 8 weeks.
11233108|NCT02424253|OG001|Outcome|Placebo|1 capsule orally once daily for 8 weeks.
11233109|NCT02424253|EG000|Reported Event|ZPL-3893787|30 mg ZPL-3893787 orally once daily for 8 weeks.
11233110|NCT02424253|EG001|Reported Event|Placebo|1 capsule orally once daily for 8 weeks.
11233111|NCT02424344|BG000|Baseline|AB/FF 400/12 μg|Aclidinium Bromide/Formoterol Fumarate 400/12 μg
11170644|NCT01998477|OG007|Outcome|TIV_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170645|NCT01998477|EG000|Reported Event|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc).
11170646|NCT01998477|EG001|Reported Event|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
11170647|NCT01998477|EG002|Reported Event|Total|Total Number of subjects
11170648|NCT01998581|BG000|Baseline|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
11170649|NCT01998581|BG001|Baseline|Restylane-L®|Lips injected with Restylane-L®
11170650|NCT01998581|BG002|Baseline|Total|Total of all reporting groups
11170651|NCT01998581|FG000|Participant Flow|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
11170652|NCT01998581|FG001|Participant Flow|Restylane-L®|Lips injected with Restylane-L®
11170653|NCT01998581|OG000|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
11170654|NCT01998581|OG001|Outcome|Restylane-L®|Lips injected with Restylane-L®
11170655|NCT01998581|EG000|Reported Event|JUVEDERM VOLBELLA® XC Initial Treatment|Lips injected with JUVEDERM VOLBELLA® XC
11170656|NCT01998581|EG001|Reported Event|Restylane-L®|Lips injected with Restylane-L®
11170657|NCT01998581|EG002|Reported Event|JUVEDERM VOLBELLA® Repeat Treatment|Lips re-injected with JUVEDERM VOLBELLA® XC
11170658|NCT01998633|BG000|Baseline|Hemophagocytic Lymphohistiocytosis (HLH)|Participants with Hemophagocytic Lymphohistiocytosis
11170659|NCT01998633|BG001|Baseline|Other Primary Immune Deficiencies (PID)|Participants with other primary immune deficiencies, including chronic active EBV disease, chronic granulomatous disease, hyper-immunoglobulin M syndrome, and immune dysregulation, polyendocrinopathy, enteropathy and X-linked (IPEX) syndrome
11170660|NCT01998633|BG002|Baseline|Total|Total of all reporting groups
11170661|NCT01998633|FG000|Participant Flow|Hematopoietic Stem Cell Transplant|"Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.~Hematopoietic Stem Cell Transplant: NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.~Alemtuzumab 0.2mg/kg Day-14,-13,-12,-11,-10~Fludarabine 30 mg/m2 on Day -8,-7,-6,-5,-4~Melphalan 140mg/m2 on Day -3~The GVHD prophylaxis will consist of the following:~Cyclosporine on Day -3 to Day +100, maintaining a level of 250-500 ng/mL, then taper to Day +180.~Methylprednisolone 2 mg/kg/day on Day -2 and -1, 1 mg/kg/day on Day 0 to Day +28, then taper over 1 month. Oral prednisone may be substituted starting on Day 0 (1.2 mg/kg/day)"
11170662|NCT01998633|OG000|Outcome|Hematopoietic Stem Cell Transplant|"Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.~Hematopoietic Stem Cell Transplant: NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.~Alemtuzumab 0.2mg/kg Day-14,-13,-12,-11,-10~Fludarabine 30 mg/m2 on Day -8,-7,-6,-5,-4~Melphalan 140mg/m2 on Day -3~The GVHD prophylaxis will consist of the following:~Cyclosporine on Day -3 to Day +100, maintaining a level of 250-500 ng/mL, then taper to Day +180.~Methylprednisolone 2 mg/kg/day on Day -2 and -1, 1 mg/kg/day on Day 0 to Day +28, then taper over 1 month. Oral prednisone may be substituted starting on Day 0 (1.2 mg/kg/day)"
11170663|NCT01998633|OG000|Outcome|Hemophagocytic Lymphohistiocytosis (HLH)|
11170664|NCT01998633|OG001|Outcome|Other Primary Immune Deficiencies (PID)|
11170665|NCT01998633|OG000|Outcome|Hemophagocytic Lymphohistiocytosis (HLH)|Participants with Hemophagocytic Lymphohistiocytosis
11170666|NCT01998633|OG001|Outcome|Other Primary Immune Deficiencies (PID)|Participants with other primary immune deficiencies, including chronic active EBV disease, chronic granulomatous disease, hyper-immunoglobulin M syndrome, and immune dysregulation, polyendocrinopathy, enteropathy and X-linked (IPEX) syndrome
11170667|NCT01998633|EG000|Reported Event|Hematopoietic Stem Cell Transplant|"Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.~Hematopoietic Stem Cell Transplant: NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.~Alemtuzumab 0.2mg/kg Day-14,-13,-12,-11,-10~Fludarabine 30 mg/m2 on Day -8,-7,-6,-5,-4~Melphalan 140mg/m2 on Day -3~The GVHD prophylaxis will consist of the following:~Cyclosporine on Day -3 to Day +100, maintaining a level of 250-500 ng/mL, then taper to Day +180.~Methylprednisolone 2 mg/kg/day on Day -2 and -1, 1 mg/kg/day on Day 0 to Day +28, then taper over 1 month. Oral prednisone may be substituted starting on Day 0 (1.2 mg/kg/day)"
11170668|NCT01998737|BG000|Baseline|Women Under Osteoporosis Suspicion|
11170669|NCT01998737|BG001|Baseline|Healthy Women|
11170670|NCT01998737|BG002|Baseline|Total|Total of all reporting groups
11170671|NCT01998737|FG000|Participant Flow|Women Under Osteoporosis Suspicion|Subjects with at least one risk factor for osteoporotic fracture.
11170672|NCT01998737|FG001|Participant Flow|Healthy Women|In healthy group females without risk factors for fracture or diseases affecting bone health were recruited.
11170673|NCT01998737|OG000|Outcome|Women Under Osteoporosis Suspicion|As defined in the protocol
11170674|NCT01998737|OG001|Outcome|Healthy Women|As defined in the protocol
11170675|NCT01998737|EG000|Reported Event|Women Under Osteoporosis Suspicion|
11170676|NCT01998737|EG001|Reported Event|Healthy Women|
11170677|NCT01998880|BG000|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
11170678|NCT01998880|BG001|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
11170679|NCT01998880|BG002|Baseline|Total|Total of all reporting groups
11170680|NCT01998880|FG000|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
11233112|NCT02424344|BG001|Baseline|Placebo|Placebo to Aclidinium/Formoterol
11233113|NCT02424344|BG002|Baseline|Total|Total of all reporting groups
10888422|NCT00506389|EG001|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
10888423|NCT00506389|EG002|Reported Event|Placebo In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
10888424|NCT00506389|EG003|Reported Event|Esmirtazapine 3.0 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 3.0 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
10888425|NCT00506389|EG004|Reported Event|Esmirtazapine 4.5 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 4.5 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
11170681|NCT01998880|FG001|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
11170682|NCT01998880|OG000|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
11170683|NCT01998880|OG001|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
11170684|NCT01998880|EG000|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
11170685|NCT01998880|EG001|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
11170686|NCT01998893|BG000|Baseline|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
11170687|NCT01998893|FG000|Participant Flow|Rituximab|Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
11170688|NCT01998893|OG000|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
11170689|NCT01998893|EG000|Reported Event|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
11170690|NCT01998906|BG000|Baseline|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
11170691|NCT01998906|BG001|Baseline|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
11170692|NCT01998906|BG002|Baseline|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
11170693|NCT01998906|BG003|Baseline|Total|Total of all reporting groups
11170694|NCT01998906|FG000|Participant Flow|HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC)|"Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
11170695|NCT01998906|FG001|Participant Flow|HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C)|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
11233114|NCT02424344|FG000|Participant Flow|AB/FF 400/12 μg|Aclidinium Bromide/Formoterol Fumarate 400/12 μg
11170696|NCT01998906|FG002|Participant Flow|HER2- Doxorubicin/Paclitaxel/CMF (HER2-C)|"Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
11170697|NCT01998906|OG000|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
11170698|NCT01998906|OG001|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
11170699|NCT01998906|OG002|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
11170700|NCT01998906|OG001|Outcome|HER2+ C|"Participants with HER2+ breast cancer received doxorubicin, paclitaxel and CMF as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
11170701|NCT01998906|OG002|Outcome|HER2- C|"Participants with HER2- breast cancer received doxorubicin, paclitaxel, and CMF as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
11170702|NCT01998906|OG000|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
11170703|NCT01998906|EG000|Reported Event|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
11170704|NCT01998906|EG001|Reported Event|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
11170705|NCT01998906|EG002|Reported Event|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
11170706|NCT01998919|BG000|Baseline|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
11170707|NCT01998919|BG001|Baseline|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
11170708|NCT01998919|BG002|Baseline|Total|Total of all reporting groups
11233115|NCT02424344|FG001|Participant Flow|Placebo|Placebo to Aclidinium/Formoterol
11233116|NCT02424344|OG000|Outcome|AB/FF 400/12 μg|Aclidinium Bromide/Formoterol Fumarate 400/12 μg
11233117|NCT02424344|OG001|Outcome|Placebo|Placebo to Aclidinium/Formoterol
11233118|NCT02424344|EG000|Reported Event|AB/FF 400/12 μg|Aclidinium Bromide/Formoterol Fumarate 400/12 μg
11233119|NCT02424344|EG001|Reported Event|Placebo|Placebo to Aclidinium/Formoterol
11233120|NCT02424357|BG000|Baseline|5% Povidone Iodine Ophthalmic Solution|patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
11233121|NCT02424357|BG001|Baseline|no Povidone-iodine Ophthalmic Solution|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
11233122|NCT02424357|BG002|Baseline|Total|Total of all reporting groups
11233123|NCT02424357|FG000|Participant Flow|5% Povidone Iodine Ophthalmic Solution|patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
11233124|NCT02424357|FG001|Participant Flow|no Povidone-iodine Ophthalmic Solution|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
11233125|NCT02424357|OG000|Outcome|5% Povidone Iodine Ophthalmic Solution|patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
11233126|NCT02424357|OG001|Outcome|no Povidone-iodine Ophthalmic Solution|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
11233127|NCT02424357|OG000|Outcome|With or Without 5% Povidone Iodine Ophthalmic Solution|patients with and without 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
11233128|NCT02424357|OG000|Outcome|With or Without 5% Povidone Iodine Ophthalmic Solution|patients who received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion and those that did not receive povidone-iodine
11233129|NCT02424357|EG000|Reported Event|5% Povidone Iodine Ophthalmic Solution|patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
11233130|NCT02424357|EG001|Reported Event|no Povidone-iodine Ophthalmic Solution|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
11233131|NCT02424383|BG000|Baseline|PTA (Lutonix® 035 DCB Catheter)|"Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.~PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.~The Lutonix® DCB through the blood vessel to the narrowed area to be treated."
11233132|NCT02424383|FG000|Participant Flow|PTA (Lutonix® 035 DCB Catheter)|"Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.~PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.~The Lutonix® DCB through the blood vessel to the narrowed area to be treated."
11233133|NCT02424383|OG000|Outcome|PTA (Lutonix® 035 DCB Catheter)|"Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.~PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.~The Lutonix® DCB through the blood vessel to the narrowed area to be treated."
11233134|NCT02424383|EG000|Reported Event|PTA (Lutonix® 035 DCB Catheter)|"Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.~PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.~The Lutonix® DCB through the blood vessel to the narrowed area to be treated."
11233135|NCT02424526|BG000|Baseline|High-intensity Group|High-intensity engaged in treadmill training 10x/week for 6 weeks
11233136|NCT02424526|BG001|Baseline|Low-intensity Group|Low-intensity engaged in treadmill training 2x/week for 6 weeks
11233137|NCT02424526|BG002|Baseline|Total|Total of all reporting groups
11233138|NCT02424526|FG000|Participant Flow|High-intensity Group|"Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks~home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist~Treadmill"
10888426|NCT00506389|EG005|Reported Event|Placebo Follow-up|After participants received placebo tablets during the Placebo Washout Period and placebo during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
10888427|NCT00506415|BG000|Baseline|Total Patients|Total number of patients enrolled in the initial open label period that may have been randomized in the double blind period or may have continued in the extended open label period.
10888428|NCT00506415|FG000|Participant Flow|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
10888429|NCT00506415|FG001|Participant Flow|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
10888430|NCT00506415|FG002|Participant Flow|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
10888431|NCT00506415|FG003|Participant Flow|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks (from week 48 to week 96) open label treatment.
10888432|NCT00506415|OG000|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
11233139|NCT02424526|FG001|Participant Flow|Low-intensity Group|"Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks~home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist~Treadmill"
11233140|NCT02424526|OG000|Outcome|High-intensity Group|"Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks~home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist~Treadmill"
11233141|NCT02424526|OG001|Outcome|Low-intensity Group|"Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks~home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist~Treadmill"
11233142|NCT02424526|OG000|Outcome|High-intensity Group|treadmill training 10x/week
11233143|NCT02424526|OG001|Outcome|Low-intensity Group|treadmill training 2x/week
11233144|NCT02424526|EG000|Reported Event|High-intensity Group|treadmill training 10x/week
11233145|NCT02424526|EG001|Reported Event|Low-intensity Group|treadmill training 2x/week
11233146|NCT02424539|BG000|Baseline|Placebo|Participants received one spray of placebo from nasal spray device A (placebo nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period.
11233147|NCT02424539|BG001|Baseline|FF 55 µg QD|Participants received one spray of FF 55 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period.
11233148|NCT02424539|BG002|Baseline|FF 110 µg QD|Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period.
11233149|NCT02424539|BG003|Baseline|Total|Total of all reporting groups
11233150|NCT02424539|FG000|Participant Flow|Placebo|Participants received one spray of placebo from nasal spray device A (placebo nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period.
11233151|NCT02424539|FG001|Participant Flow|FF 55 µg QD|Participants received one spray of FF 55 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period.
10888433|NCT00506415|OG001|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
10888434|NCT00506415|OG000|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during the double blind period.
10888435|NCT00506415|OG001|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
11233152|NCT02424539|FG002|Participant Flow|FF 110 µg QD|Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period.
10888436|NCT00506415|OG000|Outcome|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
10888437|NCT00506415|OG002|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15c m^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
10888438|NCT00506415|OG003|Outcome|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.
10888439|NCT00506415|EG000|Reported Event|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Safety population Initial Open Label (Safety-IOL) - This population consisted of all patients who received at least 1 dose of study drug during the initial open label phase and had at least 1 post baseline safety assessment during the same phase.
10888440|NCT00506415|EG001|Reported Event|Double Blind: Rivastigmine (10 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
10888441|NCT00506415|EG002|Reported Event|Double Blind: Rivastigmine (15 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
10888442|NCT00506415|EG003|Reported Event|Extended Open Label: Rivastigmine (10 cm^2)|Safety population Extended Open Label (Safety-EOL) - This population consisted of all patients who received at least 1 dose of study drug during the extended open label phase and had at least 1 post baseline safety assessment during the same phase.
11170709|NCT01998919|FG000|Participant Flow|Placebo Plus Chemotherapy|Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 times [x] area under the serum concentration-time curve [AUC]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
11170710|NCT01998919|FG001|Participant Flow|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
11170711|NCT01998919|OG000|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
11170712|NCT01998919|OG001|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
11170713|NCT01998919|EG000|Reported Event|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
11170714|NCT01998919|EG001|Reported Event|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
11170715|NCT01998958|BG000|Baseline|Placebo (Panel A: Period 1)|Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170716|NCT01998958|BG001|Baseline|Esketamine 28 mg (Panel A: Period 1)|Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170717|NCT01998958|BG002|Baseline|Esketamine 56 mg (Panel A: Period 1)|Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170718|NCT01998958|BG003|Baseline|Esketamine 84 mg (Panel A: Period 1)|Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170719|NCT01998958|BG004|Baseline|Placebo (Panel B: Period 1)|Participants self administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.
11170720|NCT01998958|BG005|Baseline|Esketamine 14 mg (Panel B: Period 1)|Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1 in Panel B.
11170721|NCT01998958|BG006|Baseline|Esketamine 56 mg (Panel B: Period 1)|Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.
10888443|NCT00506441|BG000|Baseline|MCI-196|"Open-label Period (Week 0 - 12) ; 3, 6, 9, 12, or 15 g/ day as titrated~Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
11170722|NCT01998958|BG007|Baseline|Total|Total of all reporting groups
11170723|NCT01998958|FG000|Participant Flow|Placebo (Panel A: Period 1)|Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170724|NCT01998958|FG001|Participant Flow|Esketamine 28 mg (Panel A: Period 1)|Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170725|NCT01998958|FG002|Participant Flow|Esketamine 56 mg (Panel A: Period 1)|Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170726|NCT01998958|FG003|Participant Flow|Esketamine 84 mg (Panel A: Period 1)|Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
10888444|NCT00506441|FG000|Participant Flow|MCI-196|"Open-label Period (Week 0 -12) ; 3, 6, 9, 12, or 15 g/ day as titrated~Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
10888445|NCT00506441|FG001|Participant Flow|Placebo|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
10888446|NCT00506441|OG000|Outcome|MCI-196 (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
10888447|NCT00506441|OG001|Outcome|Placebo (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
10888448|NCT00506441|OG000|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated (Week 0 -12)
10888449|NCT00506441|EG000|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15 g/ day as titrated (Week 0-12)
10888450|NCT00506441|EG001|Reported Event|MCI-196 (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)~One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
10888451|NCT00506441|EG002|Reported Event|Placebo (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)~One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
10888452|NCT00506454|BG000|Baseline|Active|Participants receiving the active drug.
10888453|NCT00506454|BG001|Baseline|Placebo|Participants receiving the placebo.
10888454|NCT00506454|BG002|Baseline|Total|Total of all reporting groups
10888455|NCT00506454|FG000|Participant Flow|Active|Participants receiving the active drug.
11170727|NCT01998958|FG004|Participant Flow|Placebo (Panel B: Period 1)|Participants self administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.
11170728|NCT01998958|FG005|Participant Flow|Esketamine 14 mg (Panel B: Period 1)|Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1 in Panel B.
10888456|NCT00506454|FG001|Participant Flow|Placebo|Participants receiving the placebo.
10888457|NCT00506454|OG000|Outcome|Treatment|Participants receiving the active drug.
11170729|NCT01998958|FG006|Participant Flow|Esketamine 56 mg (Panel B: Period 1)|Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.
11170730|NCT01998958|FG007|Participant Flow|Placebo (Panel A: Period 2) QIDS >= 11 Participants|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score greater than or equal to [>=] 11) were re-randomized to receive Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.
10888458|NCT00506454|OG001|Outcome|Placebo|Participants receiving the placebo.
10888459|NCT00506454|EG000|Reported Event|Active|Participants receiving the active drug.
10888460|NCT00506454|EG001|Reported Event|Placebo|Participants receiving the placebo.
10888461|NCT00506493|BG000|Baseline|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
10888462|NCT00506493|FG000|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
10888463|NCT00506493|OG000|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
10888464|NCT00506493|OG000|Outcome|Cardioblate Surgical Ablation System|All subjects who underwent surgical ablation with the Cardioblate Surgical Ablation System.
10888465|NCT00506493|OG000|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
10888466|NCT00506493|EG000|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
10888467|NCT00506519|BG000|Baseline|AT-150|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%~antithrombin alfa (INN name)"
10888468|NCT00506519|BG001|Baseline|AT-250|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%~antithrombin alfa (INN name)"
10888469|NCT00506519|BG002|Baseline|Control|"The best standard treatment for the underlying condition only~Control"
10888470|NCT00506519|BG003|Baseline|Total|Total of all reporting groups
10888471|NCT00506519|FG000|Participant Flow|AT-150|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%~antithrombin alfa (INN name)"
10888472|NCT00506519|FG001|Participant Flow|AT-250|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%~antithrombin alfa (INN name)"
10888473|NCT00506519|FG002|Participant Flow|Control|"The best standard treatment for the underlying condition only~Control"
10888474|NCT00506519|OG000|Outcome|AT-150|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%~antithrombin alfa (INN name)"
10888475|NCT00506519|OG001|Outcome|AT-250|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%~antithrombin alfa (INN name)"
10888476|NCT00506519|OG002|Outcome|Control|"The best standard treatment for the underlying condition only~Control"
10888477|NCT00506519|OG000|Outcome|AT-150|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%~Antithrombin alfa (INN name)"
10888478|NCT00506519|OG001|Outcome|AT-250|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%~Antithrombin alfa (INN name)"
10888479|NCT00506519|OG002|Outcome|Control|"The best standard treatment for the underlying condition only~Control (Standard treatment)"
10888480|NCT00506519|EG000|Reported Event|AT-150|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%~antithrombin alfa (INN name)"
10888481|NCT00506519|EG001|Reported Event|AT-250|"Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%~antithrombin alfa (INN name)"
10888482|NCT00506519|EG002|Reported Event|Control|"The best standard treatment for the underlying condition only~Control"
10888483|NCT00506597|BG000|Baseline|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
10888484|NCT00506597|FG000|Participant Flow|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
10888485|NCT00506597|OG000|Outcome|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
10888486|NCT00506597|EG000|Reported Event|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
11170731|NCT01998958|FG008|Participant Flow|Placebo (Panel A: Period 2) QIDS<11 Participants|Participants who were responders (with QIDS-SR16 score <11) at the end of Period 1 in Panel A continued to receive placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.
10888487|NCT00506662|BG000|Baseline|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
10888488|NCT00506662|BG001|Baseline|Insulin NPH|Individually adjusted dose of insulin NPH once daily
10888489|NCT00506662|BG002|Baseline|Total|Total of all reporting groups
10888490|NCT00506662|FG000|Participant Flow|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
10888491|NCT00506662|FG001|Participant Flow|Insulin NPH|Individually adjusted dose of insulin NPH once daily
10888492|NCT00506662|OG000|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
10888493|NCT00506662|OG001|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
10888494|NCT00506662|EG000|Reported Event|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
10888495|NCT00506662|EG001|Reported Event|Insulin NPH|Individually adjusted dose of insulin NPH once daily
10888496|NCT00506675|BG000|Baseline|Intensive|6 hours daily patching combined with daily atropine
10888497|NCT00506675|BG001|Baseline|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
10888498|NCT00506675|BG002|Baseline|Total|Total of all reporting groups
10888499|NCT00506675|FG000|Participant Flow|Intensive|6 hours daily patching combined with daily atropine
10888500|NCT00506675|FG001|Participant Flow|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
10888501|NCT00506675|OG000|Outcome|Intensive|6 hours daily patching combined with daily atropine
10888502|NCT00506675|OG001|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
10888503|NCT00506675|EG000|Reported Event|Intensive|6 hours daily patching combined with daily atropine
10888504|NCT00506675|EG001|Reported Event|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
10888505|NCT00506714|BG000|Baseline|Group 1|Healthy adults
10888506|NCT00506714|BG001|Baseline|Group 2|Adults with symptomatic hip osteoarthritis
11170732|NCT01998958|FG009|Participant Flow|Placebo to Esketamine 28mg (Panel A: Period 2)|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were re-randomized to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.
10888507|NCT00506714|BG002|Baseline|Total|Total of all reporting groups
10888508|NCT00506714|FG000|Participant Flow|Group 1|Healthy adults
10888509|NCT00506714|FG001|Participant Flow|Group 2|Adults with symptomatic hip osteoarthritis
10888510|NCT00506714|OG000|Outcome|Group 1|Healthy adults walking without a cane at baseline
10888511|NCT00506714|OG001|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking without a cane at baseline
10888512|NCT00506714|OG000|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking with a cane at baseline
10888513|NCT00506714|OG000|Outcome|Group 2|Adults with symptomatic hip osteoarthritis after four weeks of cane use
10888514|NCT00506714|EG000|Reported Event|Group 1|Healthy adults
10888515|NCT00506714|EG001|Reported Event|Group 2|Adults with symptomatic hip osteoarthritis
10888516|NCT00506753|BG000|Baseline|MI/CBT|"Motivational Interviewing followed by Cognitive Behavior Therapy~MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy"
10888517|NCT00506753|BG001|Baseline|RT/TU|"Relaxation Training followed by Treatment as Usual~RT/SU: Relaxation Training followed by Treatment as Usual"
10888518|NCT00506753|BG002|Baseline|Total|Total of all reporting groups
10888519|NCT00506753|FG000|Participant Flow|MI/CBT|"Motivational Interviewing followed by Cognitive Behavior Therapy~MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy"
10888520|NCT00506753|FG001|Participant Flow|RT/TU|"Relaxation Training followed by Treatment as Usual~RT/SU: Relaxation Training followed by Treatment as Usual"
10888521|NCT00506753|OG000|Outcome|MI/CBT|"Motivational Interviewing followed by Cognitive Behavior Therapy~MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy"
10888522|NCT00506753|OG001|Outcome|RT/TU|"Relaxation Training followed by Treatment as Usual~RT/SU: Relaxation Training followed by Treatment as Usual"
10888523|NCT00506753|EG000|Reported Event|MI/CBT|"Motivational Interviewing followed by Cognitive Behavior Therapy~MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy"
10888524|NCT00506753|EG001|Reported Event|RT/TU|"Relaxation Training followed by Treatment as Usual~RT/SU: Relaxation Training followed by Treatment as Usual"
10888525|NCT00506779|BG000|Baseline|Phase I: Paclitaxel + Imatinib Mesylate|Phase I = Paclitaxel (Taxol) 175 mg/m^2 intravenous (IV) every 21 days + Imatinib Mesylate (Gleevec) 400, 500 or 600 mg orally daily
10888526|NCT00506779|BG001|Baseline|Phase II: Paclitaxel + Imatinib Mesylate MTD 500 mg|Phase II = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate at MTD 500 mg orally daily
10888527|NCT00506779|BG002|Baseline|Total|Total of all reporting groups
10888528|NCT00506779|FG000|Participant Flow|Phase I: Imatinib Mesylate 400 mg|Cohort One = Paclitaxel (Taxol) 175 mg/m^2 intravenous (IV) every 21 days + Imatinib Mesylate (Gleevec). Phase I Maximum Tolerated Dose (MTD) to be determined from escalating doses in subsequent cohorts: 400 (this arm, Cohort One), 500 (Cohort Two) or 600 mg (Cohort Three) orally daily.
10888529|NCT00506779|FG001|Participant Flow|Phase I: Imatinib Mesylate 500 mg|Cohort Two = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 500 mg orally daily
10888530|NCT00506779|FG002|Participant Flow|Phase I: Imatinib Mesylate 600 mg|Cohort Three = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 600 mg orally daily
10888531|NCT00506779|FG003|Participant Flow|Phase II: Imatinib Mesylate MTD 500 mg|Phase II, Cohort 4 = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate at MTD 500 mg orally daily
10888532|NCT00506779|OG000|Outcome|Imatinib Mesylate 400 mg|Cohort One = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 400 mg orally daily
10888533|NCT00506779|OG001|Outcome|Imatinib Mesylate 500 mg|Cohort Two = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 500 mg orally daily
11170733|NCT01998958|FG010|Participant Flow|Placebo to Esketamine 56 mg (Panel A: Period 2)|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were re-randomized to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.
10888534|NCT00506779|OG002|Outcome|Imatinib Mesylate 600 mg|Cohort Three = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 600 mg orally daily
10888535|NCT00506779|OG000|Outcome|Participants With Measurable Disease|Paclitaxel (Taxol) 175 mg/m^2 intravenous (IV) every 21 days + Imatinib Mesylate (Gleevec) 400, 500 or 600 mg orally daily or Phase II MTD 500 mg
10888536|NCT00506779|OG001|Outcome|Participants With Non-Measurable Disease|Paclitaxel (Taxol) 175 mg/m^2 intravenous (IV) every 21 days + Imatinib Mesylate (Gleevec) 400, 500 or 600 mg orally daily or Phase II MTD 500 mg
10888537|NCT00506779|EG000|Reported Event|Phase I: Imatinib Mesylate 400mg|Cohort One = Paclitaxel (Taxol) 175 mg/m^2 intravenous (IV) every 21 days + Imatinib Mesylate (Gleevec). Phase I Maximum Tolerated Dose (MTD) to be determined from escalating doses in subsequent cohorts: 400 (this arm, Cohort One), 500 (Cohort Two) or 600 mg (Cohort Three) orally daily.
10888538|NCT00506779|EG001|Reported Event|Phase II: Imatinib Mesylate 500 mg|Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 500 mg orally daily
10888539|NCT00506779|EG002|Reported Event|Phase 1: Imatinib Mesylate 600 mg|Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 600 mg orally daily
10888540|NCT00506779|EG003|Reported Event|Phase II: Imatinib Mesylate MTD 500 mg|Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate at MTD 500 mg orally
10888541|NCT00506831|BG000|Baseline|Imatinib Mesylate|All patients were treated with imatinib mesylate at a mean dosage of 300 mg daily.
11170734|NCT01998958|FG011|Participant Flow|Placebo to Esketamine 84 mg (Panel A: Period 2)|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were re-randomized to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.
11170735|NCT01998958|FG012|Participant Flow|Esketamine 28 mg (Panel A: Period 2)|Participants who received esketamine 28 mg in Period 1 of Panel A continued to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.
10888542|NCT00506831|FG000|Participant Flow|Imatinib Mesylate|All patients were treated with imatinib mesylate at a mean dosage of 300 mg daily.
10888543|NCT00506831|OG000|Outcome|Imatinib Mesylate|All patients were treated with imatinib mesylate at a mean dosage of 300 mg daily.
10888544|NCT00506831|EG000|Reported Event|Imatinib Mesylate|All patients were treated with imatinib mesylate at a mean dosage of 300 mg daily.
10888545|NCT00506857|BG000|Baseline|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
10888546|NCT00506857|FG000|Participant Flow|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
10888547|NCT00506857|OG000|Outcome|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
10888548|NCT00506857|OG000|Outcome|Tacrolimus + Methotrexate|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
10888549|NCT00506857|EG000|Reported Event|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
10888550|NCT00506883|BG000|Baseline|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
10888551|NCT00506883|BG001|Baseline|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
10888552|NCT00506883|BG002|Baseline|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
10888553|NCT00506883|BG003|Baseline|Total|Total of all reporting groups
10888554|NCT00506883|FG000|Participant Flow|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
11170736|NCT01998958|FG013|Participant Flow|Esketamine 56 mg (Panel A: Period 2)|Participants who received esketamine 56 mg in Period 1 of Panel A continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.
11170737|NCT01998958|FG014|Participant Flow|Esketamine 84 mg (Panel A: Period 2)|Participants who received esketamine 84 mg in Period 1 of Panel A continued to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.
11170738|NCT01998958|FG015|Participant Flow|Placebo (Panel B: Period 2) QIDS >=11 Participants|Participants who were non-responders with QIDS-SR16 score >=11 at the end of Period 1 were re-randomized to receive placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes using 4 separate devices) on Days 8 and 11 of Period 2 in Panel B.
11170739|NCT01998958|FG016|Participant Flow|Placebo (Panel B: Period 2) QIDS<11 Participants|Participants who were responders with QIDS-SR16 score <11 at the end of Period 1 continued to receive placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes using 4 separate devices) on Days 8 and 11 in Period 2.
11170740|NCT01998958|FG017|Participant Flow|Placebo to Esketamine 14mg (Panel B: Period 2)|Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score >=11 at the end of Period 1 were re-randomized to receive esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo in other nostril at 0 minute and 1 spray of placebo in each nostril at 5 minutes using 4 separate devices) on Days 8 and 11 in Period 2.
11170741|NCT01998958|FG018|Participant Flow|Placebo to Esketamine 56mg (Panel B: Period 2)|Participants who received placebo in Period 1 and were non-responders (with QIDS-SR16 score >=11) at the end of Period 1 in Panel B were re-randomized to receive esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
10888555|NCT00506883|FG001|Participant Flow|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
10888556|NCT00506883|FG002|Participant Flow|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
10888557|NCT00506883|OG000|Outcome|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
11170742|NCT01998958|FG019|Participant Flow|Esketamine 14 mg (Panel B: Period 2)|Participants who received esketamine 14 mg in Period 1 of Panel B continued to receive esketamine 14 mg (1 spray of esketamine 14 mg to one nostril and 1 spray of placebo into other nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 in Period 2.
11170743|NCT01998958|FG020|Participant Flow|Esketamine 56 mg (Panel B: Period 2)|Participants who received esketamine 56 mg in Period 1 of Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
11170744|NCT01998958|FG021|Participant Flow|Placebo/Placebo/Open Label Esketamine (Panel A)|Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.
10888558|NCT00506883|OG001|Outcome|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
10888559|NCT00506883|OG002|Outcome|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
11170745|NCT01998958|FG022|Participant Flow|Placebo/Esketamine/Open Label Esketamine (Panel A)|Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.
11170746|NCT01998958|FG023|Participant Flow|Esketamine/Esketamine/Open Label Esketamine (Panel A)|Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.
10888560|NCT00506883|EG000|Reported Event|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
10888561|NCT00506883|EG001|Reported Event|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
10888562|NCT00506883|EG002|Reported Event|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
10888563|NCT00506922|BG000|Baseline|No Pentostatin|Group 1: No Pentostatin
10888564|NCT00506922|BG001|Baseline|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
10888565|NCT00506922|BG002|Baseline|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
10888566|NCT00506922|BG003|Baseline|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
11170747|NCT01998958|FG024|Participant Flow|Placebo/Placebo/Open Label Esketamine (Panel B)|Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22 and 25. The doses for the optional open-label treatment phase included 14, 28 and 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22 and 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.
11170748|NCT01998958|FG025|Participant Flow|Placebo/Esketamine/Open Label Esketamine (Panel B)|Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with open label phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22 and 25. The doses for the optional open-label treatment phase included 14, 28 and 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22 and 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.
11170749|NCT01998958|FG026|Participant Flow|Esketamine/Esketamine/Open Label Esketamine (Panel B)|Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22 and 25. The doses for the optional open-label treatment phase included 14, 28 and 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22 and 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.
11170750|NCT01998958|FG027|Participant Flow|Placebo: Follow up Phase|All participants whose last dose was Placebo in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
11170751|NCT01998958|FG028|Participant Flow|Esketamine 14 mg: Follow up Phase|All participants whose last dose was esketamine 14 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
10888567|NCT00506922|BG004|Baseline|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
10888568|NCT00506922|BG005|Baseline|Total|Total of all reporting groups
10888569|NCT00506922|FG000|Participant Flow|No Pentostatin|Group 1: No Pentostatin
10888570|NCT00506922|FG001|Participant Flow|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
10888571|NCT00506922|FG002|Participant Flow|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
10888572|NCT00506922|FG003|Participant Flow|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
10888573|NCT00506922|FG004|Participant Flow|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
10888574|NCT00506922|OG000|Outcome|Pentostatin|150 patients were enrolled, 2 patients not treated, 38 patients were Group 1 (no Pentostatin), the remaining Groups 2,3,4 and 5, 110 patients were analysed that received the Pentostatin.
10888575|NCT00506922|EG000|Reported Event|No Pentostatin|Group 1: No Pentostatin
10888576|NCT00506922|EG001|Reported Event|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
10888577|NCT00506922|EG002|Reported Event|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
10888578|NCT00506922|EG003|Reported Event|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
10888579|NCT00506922|EG004|Reported Event|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
10888580|NCT00506948|BG000|Baseline|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
11170752|NCT01998958|FG029|Participant Flow|Esketamine 28 mg: Follow up Phase|All participants whose last dose was esketamine 28 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
10888581|NCT00506948|FG000|Participant Flow|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
10888582|NCT00506948|OG000|Outcome|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
10888583|NCT00506948|EG000|Reported Event|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
10888584|NCT00507026|BG000|Baseline|Diclofenac (DIC075V)|Participants at high risk (weighing <50 k), age >= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing >95 kg received DIC075V 50 mg. Participants weighing >95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888585|NCT00507026|BG001|Baseline|Ketorolac|Participants at high risk (weighing <50 k, >=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing >95 kg received ketorolac tromethamine 30 mg. Participants weighing >95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
11170753|NCT01998958|FG030|Participant Flow|Esketamine 56 mg: Follow up Phase|All participants whose last dose was esketamine 56 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
11170754|NCT01998958|FG031|Participant Flow|Esketamine 84 mg: Follow up Phase|All participants whose last dose was esketamine 84 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
11170755|NCT01998958|OG000|Outcome|Panel A: Period 1 Placebo|Participants self administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1.
11170756|NCT01998958|OG001|Outcome|Panel A: Period 1 Esketamine 28 mg|Participants self administered esketamine 28 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1.
11170757|NCT01998958|OG002|Outcome|Panel A: Period 1 Esketamine 56 mg|Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1.
11170758|NCT01998958|OG003|Outcome|Panel A: Period 1 Esketamine 84 mg|Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1.
11170759|NCT01998958|OG004|Outcome|Panel B: Period 1 Placebo|Participants self administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1.
11170760|NCT01998958|OG005|Outcome|Panel B: Period 1 Esketamine 14 mg|Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1.
11170761|NCT01998958|OG006|Outcome|Panel B: Period 1 Esketamine 56 mg|Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1.
11170762|NCT01998958|OG000|Outcome|Panel A: Period 2 Placebo|Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score >=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.
11170763|NCT01998958|OG001|Outcome|Panel A:Period 2 Esketamine 28 mg|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score >=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.
11170764|NCT01998958|OG002|Outcome|Panel A: Period 2 Esketamine 56 mg|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.
11170765|NCT01998958|OG003|Outcome|Panel A: Period 2 Esketamine 84 mg|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score >=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.
11170766|NCT01998958|OG004|Outcome|Panel B: Period 2 Placebo|Participants who were non-responders with QIDS-SR 16 score >=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.
11170767|NCT01998958|OG005|Outcome|Panel B: Period 2 Esketamine 14 mg|Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score >=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.
11170768|NCT01998958|OG006|Outcome|Panel B:Period 2 Esketamine 56 mg|Participants who were responders (with QIDS-SR16 score <11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
11170769|NCT01998958|OG000|Outcome|Panel A: Placebo (Period 1 and 2)|Participants who received same placebo (1 spray to each nostril at 0, 5 and 10 minutes) treatment in Period 1 and 2 of Panel A.
11170770|NCT01998958|OG001|Outcome|Panel A: Esketamine 28 mg (Period 1 and 2)|Participants who received same esketamine 28mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) treatment in Period 1 and 2 of Panel A.
11170771|NCT01998958|OG002|Outcome|Panel A: Esketamine 56 mg (Period 1 and 2)|Participants who received same esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) treatment in Period 1 and 2 of Panel A.
11170772|NCT01998958|OG003|Outcome|Panel A: Esketamine 84 mg (Period 1 and 2)|Participants who received same esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) treatment in Period 1 and 2 of Panel A.
11170773|NCT01998958|OG004|Outcome|Panel B: Placebo (Period 1 and 2)|Participants who received same placebo (1 spray to each nostril at 0 and 5 minutes) treatment in Period 1 and 2 of Panel B.
11170774|NCT01998958|OG005|Outcome|Panel B: Esketamine 14 mg (Period 1 and 2)|Participants who received same esketamine 14 mg (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) treatment in Period 1 and 2 of Panel B.
11170775|NCT01998958|OG006|Outcome|Panel B: Esketamine 56 mg (Period 1 and 2)|Participants who received same esketamine 56 mg (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) treatment in Period 1 and 2 of Panel B.
11170776|NCT01998958|OG001|Outcome|Panel A: Period 2 Esketamine 28 mg|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score >=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.
11170777|NCT01998958|OG006|Outcome|Panel B: Period 2 Esketamine 56 mg|Participants who were responders (with QIDS-SR16 score <11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
11170778|NCT01998958|OG000|Outcome|Panel A: Period 1: Placebo|Participants self administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1.
11170779|NCT01998958|OG002|Outcome|Panel A: Period 1: Esketamine 56 mg|Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1.
11170780|NCT01998958|EG000|Reported Event|Placebo (Panel A and B: Period 1)|Panel A: Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A. Panel B: Participants self-administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.
11170781|NCT01998958|EG001|Reported Event|Esketamine 28 mg (Panel A: Period 1)|Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170782|NCT01998958|EG002|Reported Event|Placebo (Panel A and B: Period 2) QIDS >=11 Participants|Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were randomly reassigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A. Panel B: Participants who were non-responders with QIDS-SR16 score >=11 at the end of Period 1 were randomly assigned to receive placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes using 4 separate devices) on Days 8 and 11 of Period 2 in Panel B.
11233153|NCT02424539|OG000|Outcome|Placebo|Participants received one spray of placebo from nasal spray device A (placebo nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period.
11170783|NCT01998958|EG003|Reported Event|Placebo to Esketamine 14mg (Panel B: Period 2)|Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score >=11 at the end of Period 1 were randomly reassigned to receive esketamine 14 mg intranasally (1 spray of esketamine 14 mg into once nostril and 1 spray of placebo in other nostril at 0 minute and 1 spray of placebo in each nostril at 5 minutes using 4 separate devices) on Days 8 and 11 in Period 2 of Panel B.
11170784|NCT01998958|EG004|Reported Event|Placebo to Esketamine 28mg (Panel A: Period 2)|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were randomly reassigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.
11170785|NCT01998958|EG005|Reported Event|Placebo to Esketamine 56mg (Panel A and B: Period 2)|Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were randomly reassigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2 in Panel A. Panel B: Participants who were responders (with QIDS-SR16 score <11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2 of Panel B.
11170786|NCT01998958|EG006|Reported Event|Placebo to Esketamine 84 mg (Panel A: Period 2)|Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were randomly reassigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.
11170787|NCT01998958|EG007|Reported Event|Placebo (Panel A and Panel B: Period 2)|All participants who received placebo in Period 2 of Panel A and B (including participants with QIDS-SR16 score >=11 and QIDS-SR16 score <11) in double-blind phase.
11170788|NCT01998958|EG008|Reported Event|Esketamine 14 mg (Panel B: Period 2)|Participants who received esketamine 14 mg in Period 1 of Panel B continued to receive esketamine 14 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2 of Panel B.
11170789|NCT01998958|EG009|Reported Event|Esketamine 28 mg (Panel A: Period 2)|Participants who received esketamine 28 mg in Period 1 of Panel A continued to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.
11170790|NCT01998958|EG010|Reported Event|Esketamine 56 mg (Panel A and B: Period 2)|Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score >=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2. Panel B: Participants who were responders (with QIDS-SR16 score <11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
11170791|NCT01998958|EG011|Reported Event|Placebo/Placebo/Open Label Esketamine (Panel A and B)|Panel A: Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label (OL) phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32, 39, 46,60,74. Doses for optional OL phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25,32,39,46 could be adjusted to next lower or higher dose, based on investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60, 74. Panel B: Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22, 25. Doses for OL phase included 14, 28, 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25 could be adjusted to next lower or higher dose, based on investigator's clinical judgment.
11170792|NCT01998958|EG012|Reported Event|Placebo/Esketamine/Open Label Esketamine (Panel A and B)|Panel A: Participants who received Placebo in Period 1, esketamine in Period 2 and elected to continue with OL phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32,39,46,60, 74. Doses for OL phase included 28,56,84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25,32,39, 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60,74. Panel B: Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15,18,22,25. Doses for OL phase included 14,28,56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25 could be adjusted to next lower or higher dose, based on the investigator's clinical judgment.
11170793|NCT01998958|EG013|Reported Event|Esketamine/Esketamine/Open Label Esketamine (Panel A and B)|Panel A: Participants who received esketamine in Period 1 and 2 and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32,39,46,60,74. Doses for OL treatment phase included 28, 56, 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22,25,32,39, 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60,74.Panel B: Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22, 25. Doses for OL phase included 14, 28, 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.
11170794|NCT01998958|EG014|Reported Event|Placebo: Follow up Phase|All participants whose last dose was Placebo in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
11170795|NCT01998958|EG015|Reported Event|Esketamine 14 mg: Follow up Phase|All participants whose last dose was esketamine 14 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
11170796|NCT01998958|EG016|Reported Event|Esketamine 28 mg: Follow up Phase|All participants whose last dose was esketamine 28 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
11170797|NCT01998958|EG017|Reported Event|Esketamine 56 mg: Follow up Phase|All participants whose last dose was esketamine 56 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
11170798|NCT01998958|EG018|Reported Event|Esketamine 84 mg: Follow up Phase|All participants whose last dose was esketamine 84 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
11170799|NCT01998958|EG019|Reported Event|Esketamine 14 mg (Panel B: Period 1)|Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1 in Panel B.
11170800|NCT01998958|EG020|Reported Event|Esketamine 56 mg (Panel A and B: Period 1)|Panel A: Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1. Panel B: Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1.
11170801|NCT01998958|EG021|Reported Event|Esketamine 84 mg (Panel A: Period 1)|Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.
11170802|NCT01998958|EG022|Reported Event|Esketamine 84 mg (Panel A: Period 2)|Participants who received esketamine 84 mg in Period 1 of Panel A continued to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.
11170803|NCT01998984|BG000|Baseline|Ingenol 2 Days|2 days treatment with ingenol mebutate 0.06% gel and 2 days treatment with vehicle gel
11170804|NCT01998984|BG001|Baseline|Ingenol 3 Days|3 days treatment with ingenol mebutate 0.06% gel and 1 day treatment with vehicle gel
11170805|NCT01998984|BG002|Baseline|Ingenol 4 Days|4 days treatment with ingenol mebutate 0.06% gel
11170806|NCT01998984|BG003|Baseline|Vehicle|4 days treatment with vehicle gel
11170807|NCT01998984|BG004|Baseline|Total|Total of all reporting groups
11170808|NCT01998984|FG000|Participant Flow|Ingenol 2 Days|Ingenol mebutate gel 0.06% and vehicle gel applied topically once daily to a contiguous area of approximately 250 cm2 sun-damaged skin on trunk (except chest), or extremities (arm with or without back of hand, or leg). Vehicle gel was applied for 2 days and ingenol mebutate gel 0.06% was applied for 2 days for a total 4 consecutive days.
11170809|NCT01998984|FG001|Participant Flow|Ingenol 3 Days|Ingenol mebutate gel 0.06% and vehicle gel applied topically once daily to a contiguous area of approximately 250 cm2 sun-damaged skin on trunk (except chest), or extremities (arm with or without back of hand, or leg). Vehicle gel was applied for 1 day and ingenol mebutate gel 0.06% was applied for 3 days for a total 4 consecutive days.
11170810|NCT01998984|FG002|Participant Flow|Ingenol 4 Days|Ingenol mebutate gel 0.06% applied topically once daily to a contiguous area of approximately 250 cm2 sun-damaged skin on trunk (except chest), or extremities (arm with or without back of hand, or leg) for 4 consecutive days.
11170811|NCT01998984|FG003|Participant Flow|Vehicle|Vehicle gel applied topically once daily to a contiguous area of approximately 250 cm2 sun-damaged skin on trunk (except chest), or extremities (arm with or without back of hand, or leg) for 4 consecutive days.
11170812|NCT01998984|OG000|Outcome|Ingenol 2 Days|2 days treatment with ingenol mebutate 0.06% gel and 2 days treatment with vehicle gel
11170813|NCT01998984|OG001|Outcome|Ingenol 3 Days|1 day treatment with vehicle gel and 3 days treatment with ingenol mebutate 0.06% gel
11170814|NCT01998984|OG002|Outcome|Ingenol 4 Days|4 days treatment with ingenol mebutate 0.06% gel
11170815|NCT01998984|OG003|Outcome|Vehicle|4 days treatment with vehicle gel
11170816|NCT01998984|EG000|Reported Event|Ingenol 2 Days|2 days treatment with ingenol mebutate 0.06% gel and 2 days treatment with vehicle gel
11170817|NCT01998984|EG001|Reported Event|Ingenol 3 Days|1 day treatment with vehicle gel and 3 days treatment with ingenol mebutate 0.06% gel
11170818|NCT01998984|EG002|Reported Event|Ingenol 4 Days|4 days treatment with ingenol mebutate 0.06% gel
11170819|NCT01998984|EG003|Reported Event|Vehicle|4 days treatment with vehicle gel
11170820|NCT01999114|BG000|Baseline|BTDS|"Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr~Buprenorphine transdermal patch: Buprenorphine patch applied transdermally"
11170821|NCT01999114|BG001|Baseline|BTDS With Naltrexone|"Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets~Buprenorphine transdermal patch: Buprenorphine patch applied transdermally~Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours"
11170822|NCT01999114|BG002|Baseline|Naltrexone|"Naltrexone 50 mg tablets~Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours"
11170823|NCT01999114|BG003|Baseline|Moxifloxacin|"Moxifloxacin 400-mg tablets~Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17"
11170824|NCT01999114|BG004|Baseline|Placebo|"Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets~Placebos (for TDS and for naltrexone and for moxifloxacin): Matching placebos"
11170825|NCT01999114|BG005|Baseline|Total|Total of all reporting groups
11170826|NCT01999114|FG000|Participant Flow|BTDS|"Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr~Buprenorphine transdermal patch: Buprenorphine patch applied transdermally"
10888586|NCT00507026|BG002|Baseline|Placebo|Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888587|NCT00507026|BG003|Baseline|Total|Total of all reporting groups
10888588|NCT00507026|FG000|Participant Flow|Diclofenac (DIC075V)|Participants at high risk (weighing less than [<] 50 killogram [k]), age >= 65 years, elevated nonsteroidal anti-inflammatory drugs [NSAID]-related gastrointestinal [GI] risk factors, or with hepatic or renal impairment) received DIC075V 18.75 milligram (mg). Participants without any risk factor and weighing greater than (>) 95 kg received DIC075V 50 mg. Participants weighing >95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as intravenous (IV) bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888589|NCT00507026|FG001|Participant Flow|Ketorolac|Participants at high risk (weighing <50 k, >=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing >95 kg received ketorolac tromethamine 30 mg. Participants weighing >95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888590|NCT00507026|FG002|Participant Flow|Placebo|Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888591|NCT00507026|OG000|Outcome|Diclofenac (DIC075V)|Participants at high risk (weighing <50 k), age >= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing >95 kg received DIC075V 50 mg. Participants weighing >95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888592|NCT00507026|OG001|Outcome|Ketorolac|Participants at high risk (weighing <50 k, >=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing >95 kg received ketorolac tromethamine 30 mg. Participants weighing >95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888593|NCT00507026|OG002|Outcome|Placebo|Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888594|NCT00507026|EG000|Reported Event|Diclofenac (DIC075V)|Participants at high risk (weighing <50 k), age >= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing >95 kg received DIC075V 50 mg. Participants weighing >95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888595|NCT00507026|EG001|Reported Event|Ketorolac|Participants at high risk (weighing <50 k, >=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing >95 kg received ketorolac tromethamine 30 mg. Participants weighing >95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
10888596|NCT00507026|EG002|Reported Event|Placebo|Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
11233154|NCT02424539|OG001|Outcome|FF 55 µg QD|Participants received one spray of FF 55 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period.
11233155|NCT02424539|OG002|Outcome|FF 110 µg QD|Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period.
10888597|NCT00507130|BG000|Baseline|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
10888598|NCT00507130|BG001|Baseline|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
10888599|NCT00507130|BG002|Baseline|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
10888600|NCT00507130|BG003|Baseline|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
10888601|NCT00507130|BG004|Baseline|Total|Total of all reporting groups
10888602|NCT00507130|FG000|Participant Flow|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
10888603|NCT00507130|FG001|Participant Flow|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
10888604|NCT00507130|FG002|Participant Flow|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
10888605|NCT00507130|FG003|Participant Flow|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
10888606|NCT00507130|OG000|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
10888607|NCT00507130|OG001|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
10888608|NCT00507130|OG002|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
10888609|NCT00507130|OG003|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
10888610|NCT00507130|EG000|Reported Event|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
10888611|NCT00507130|EG001|Reported Event|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
10888612|NCT00507130|EG002|Reported Event|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
10888613|NCT00507130|EG003|Reported Event|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
10914700|NCT00632489|OG002|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
10914701|NCT00632489|EG000|Reported Event|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
10914702|NCT00632489|EG001|Reported Event|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
10914703|NCT00632489|EG002|Reported Event|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
10914704|NCT00632502|BG000|Baseline|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
10914705|NCT00632502|BG001|Baseline|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
11170827|NCT01999114|FG001|Participant Flow|BTDS With Naltrexone|"Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets~Buprenorphine transdermal patch: Buprenorphine patch applied transdermally~Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours"
11170828|NCT01999114|FG002|Participant Flow|Naltrexone|"Naltrexone 50 mg tablets~Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours"
11170829|NCT01999114|FG003|Participant Flow|Moxifloxacin|"Moxifloxacin 400-mg tablets~Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17"
10914706|NCT00632502|BG002|Baseline|Total|Total of all reporting groups
10914707|NCT00632502|FG000|Participant Flow|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
10914708|NCT00632502|FG001|Participant Flow|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
10914709|NCT00632502|OG000|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
10914710|NCT00632502|OG001|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
10914711|NCT00632502|OG000|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
10914712|NCT00632502|EG000|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
10914713|NCT00632502|EG001|Reported Event|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
10914714|NCT00632541|BG000|Baseline|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
10914715|NCT00632541|FG000|Participant Flow|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week. 1 Cycle = 4 weeks. Imaging every third cycle.
10914716|NCT00632541|OG000|Outcome|Single Arm A|"Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle~Sorafenib: Sorafenib 200mg po daily~Bevacizumab: Bevacizumab 5mg/kg every other week~1 Cycle = 4 weeks~Imaging: Imaging every third cycle"
10914717|NCT00632541|EG000|Reported Event|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
11170830|NCT01999114|FG004|Participant Flow|Placebo|"Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets~Placebos (for BTDS and for naltrexone and for moxifloxacin): Matching placebos"
11170831|NCT01999114|OG000|Outcome|BTDS Only (Placebo-corrected ΔΔQTcI)|BTDS 10 mcg/hr
11170832|NCT01999114|OG001|Outcome|BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)|BTDS 10 mcg/hr and naltrexone 50 mg tablets
11170833|NCT01999114|OG002|Outcome|Naltrexone Alone (Placebo-corrected ΔΔQTcI)|Naltrexone 50 mg tablets
11170834|NCT01999114|OG003|Outcome|Moxifloxacin (Placebo-corrected ΔΔQTcI)|Moxifloxacin 400 mg tablet (positive control)
11170835|NCT01999114|OG000|Outcome|BTDS Only (Placebo-corrected ΔΔQTcI)|BTDS 40 mcg/hr
10888614|NCT00507208|BG000|Baseline|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
10888615|NCT00507208|BG001|Baseline|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
10888616|NCT00507208|BG002|Baseline|Total|Total of all reporting groups
10888617|NCT00507208|FG000|Participant Flow|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
10888618|NCT00507208|FG001|Participant Flow|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
10888619|NCT00507208|OG000|Outcome|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
10888620|NCT00507208|OG001|Outcome|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
10888621|NCT00507208|EG000|Reported Event|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
10888622|NCT00507208|EG001|Reported Event|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
10888623|NCT00507416|BG000|Baseline|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
11170836|NCT01999114|OG001|Outcome|BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)|BTDS 40 mcg/hr and naltrexone 50 mg tablets
10888624|NCT00507416|BG001|Baseline|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888625|NCT00507416|BG002|Baseline|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888626|NCT00507416|BG003|Baseline|Total|Total of all reporting groups
10888627|NCT00507416|FG000|Participant Flow|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888628|NCT00507416|FG001|Participant Flow|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888629|NCT00507416|FG002|Participant Flow|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888630|NCT00507416|OG000|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888631|NCT00507416|OG001|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888632|NCT00507416|OG002|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888633|NCT00507416|EG000|Reported Event|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
11170837|NCT01999114|OG003|Outcome|Moxifloxacin (Placebo-corrected ΔΔQTcI)|Moxifoxacin 400 mg tablet (positive control)
11170838|NCT01999114|OG000|Outcome|BTDS Only (Placebo-corrected ΔΔQTcI)|BTDS 80 mcg/hr
11170839|NCT01999114|OG001|Outcome|BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)|BTDS 80 mcg/hr and naltrexone 50 mg tablets
11170840|NCT01999114|OG000|Outcome|BTDS Only|BTDS 10 mcg/hr
11170841|NCT01999114|OG001|Outcome|BTDS With Naltrexone|BTDS 10 mcg/hr and naltrexone 50 mg tablets
11170842|NCT01999114|OG002|Outcome|Naltrexone Alone|Naltrexone 50 mg tablets
11170843|NCT01999114|OG003|Outcome|Moxifloxacin|Moxifloxacin 400 mg tablet (positive control)
11170844|NCT01999114|OG004|Outcome|Placebo|Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
11170845|NCT01999114|OG000|Outcome|BTDS Only|BTDS 40 mcg/hr
11233156|NCT02424539|EG000|Reported Event|Placebo|Participants received one spray of placebo from nasal spray device A (placebo nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period.
11170846|NCT01999114|OG001|Outcome|BTDS With Naltrexone|BTDS 40 mcg/hr and naltrexone 50 mg tablets
10888634|NCT00507416|EG001|Reported Event|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888635|NCT00507416|EG002|Reported Event|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
10888636|NCT00507429|BG000|Baseline|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
10888637|NCT00507429|BG001|Baseline|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
10888638|NCT00507429|BG002|Baseline|Total|Total of all reporting groups
10888639|NCT00507429|FG000|Participant Flow|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
10888640|NCT00507429|FG001|Participant Flow|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
10888641|NCT00507429|OG000|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
10888642|NCT00507429|OG001|Outcome|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
10888643|NCT00507429|OG000|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
10888644|NCT00507429|OG001|Outcome|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
10888645|NCT00507429|EG000|Reported Event|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
10888646|NCT00507429|EG001|Reported Event|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
10888647|NCT00507442|BG000|Baseline|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888648|NCT00507442|BG001|Baseline|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888649|NCT00507442|BG002|Baseline|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
10888650|NCT00507442|BG003|Baseline|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
10888651|NCT00507442|BG004|Baseline|Total|Total of all reporting groups
10888652|NCT00507442|FG000|Participant Flow|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888653|NCT00507442|FG001|Participant Flow|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888654|NCT00507442|FG002|Participant Flow|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
11170847|NCT01999114|OG003|Outcome|Moxifloxacin|Moxifloxacin 400 mg tablets
11170848|NCT01999114|OG000|Outcome|BTDS Only|BTDS 80 mcg/hr
11170849|NCT01999114|OG001|Outcome|BTDS With Naltrexone|BTDS 80 mcg/hr and naltrexone 50 mg tablets
11170850|NCT01999114|EG000|Reported Event|BTDS|"Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr~Buprenorphine transdermal patch: Buprenorphine patch applied transdermally"
11233157|NCT02424539|EG001|Reported Event|FF 55 µg QD|Participants received one spray of FF 55 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period.
10888655|NCT00507442|FG003|Participant Flow|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
10888656|NCT00507442|OG000|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888657|NCT00507442|OG001|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888658|NCT00507442|OG002|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
10888659|NCT00507442|OG003|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
10888660|NCT00507442|OG000|Outcome|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888661|NCT00507442|OG001|Outcome|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888662|NCT00507442|OG002|Outcome|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
10888663|NCT00507442|OG003|Outcome|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
10888664|NCT00507442|EG000|Reported Event|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888665|NCT00507442|EG001|Reported Event|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
10888666|NCT00507442|EG002|Reported Event|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
10888667|NCT00507442|EG003|Reported Event|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
10888668|NCT00507455|BG000|Baseline|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
10888669|NCT00507455|BG001|Baseline|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
10888670|NCT00507455|BG002|Baseline|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
10888671|NCT00507455|BG003|Baseline|Total|Total of all reporting groups
10888672|NCT00507455|FG000|Participant Flow|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
10888673|NCT00507455|FG001|Participant Flow|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets for 12 weeks.
10888674|NCT00507455|FG002|Participant Flow|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS)tablets for 12 weeks.
10888675|NCT00507455|OG000|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
11170851|NCT01999114|EG001|Reported Event|BTDS With Naltrexone|"Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets~Buprenorphine transdermal patch: Buprenorphine patch applied transdermally~Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours"
11170852|NCT01999114|EG002|Reported Event|Naltrexone|"Naltrexone 50 mg tablets~Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours"
10851082|NCT01650285|FG000|Participant Flow|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
11233158|NCT02424539|EG002|Reported Event|FF 110 µg QD|Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period.
10888676|NCT00507455|OG001|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
10888677|NCT00507455|OG002|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
10888678|NCT00507455|EG000|Reported Event|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
10888679|NCT00507455|EG001|Reported Event|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
10888680|NCT00507455|EG002|Reported Event|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
10888681|NCT00507507|BG000|Baseline|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
10888682|NCT00507507|BG001|Baseline|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
10888683|NCT00507507|BG002|Baseline|Total|Total of all reporting groups
10888684|NCT00507507|FG000|Participant Flow|Tenofovir DF|Participants were randomized to receive tenofovir disoproxil fumarate (tenofovir DF; 300 mg tablet) plus placebo to match emtricitabine (FTC; tablet) orally once daily.
10888685|NCT00507507|FG001|Participant Flow|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
10888686|NCT00507507|OG000|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
10888687|NCT00507507|OG001|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
10888688|NCT00507507|EG000|Reported Event|Tenofovir DF (Treatment Period)|"Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.~Adverse events (AEs) for this reporting group are reported for the entire treatment period."
10888689|NCT00507507|EG001|Reported Event|FTC+Tenofovir DF (Treatment Period)|"Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.~AEs for this reporting group are reported for the entire treatment period."
10888690|NCT00507507|EG002|Reported Event|Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.~AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
10888691|NCT00507507|EG003|Reported Event|FTC+Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the FTC+Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.~AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
10888692|NCT00507546|BG000|Baseline|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
10888693|NCT00507546|BG001|Baseline|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
10888694|NCT00507546|BG002|Baseline|Total|Total of all reporting groups
10888695|NCT00507546|FG000|Participant Flow|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
10888696|NCT00507546|FG001|Participant Flow|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
10888697|NCT00507546|OG000|Outcome|Ramelteon|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
10888698|NCT00507546|OG001|Outcome|Placebo|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
10888699|NCT00507546|OG000|Outcome|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
10888700|NCT00507546|OG001|Outcome|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
10888701|NCT00507546|EG000|Reported Event|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
10888702|NCT00507546|EG001|Reported Event|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
10888703|NCT00507559|BG000|Baseline|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
10888704|NCT00507559|FG000|Participant Flow|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
10888705|NCT00507559|OG000|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
10888706|NCT00507559|EG000|Reported Event|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
10888707|NCT00507689|BG000|Baseline|FTC/TDF+HBIg|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
10888708|NCT00507689|BG001|Baseline|FTC/TDF|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
10888709|NCT00507689|BG002|Baseline|Not Randomized|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period only. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
10888710|NCT00507689|BG003|Baseline|Total|Total of all reporting groups
10888711|NCT00507689|FG000|Participant Flow|FTC/TDF+HBIg|For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
11170853|NCT01999114|EG003|Reported Event|Moxifloxacin|"Moxifloxacin 400-mg tablets~Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17"
10888712|NCT00507689|FG001|Participant Flow|FTC/TDF|For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.
10888713|NCT00507689|OG000|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
10888714|NCT00507689|OG001|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
10888715|NCT00507689|EG000|Reported Event|FTC/TDF+HBIg, Pre-randomization Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the pre-randomization period, and were analyzed from pretreatment baseline to Week 24 (pre-randomization period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
10888716|NCT00507689|EG001|Reported Event|FTC/TDF+HBIg, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
10888717|NCT00507689|EG002|Reported Event|FTC/TDF, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
10888718|NCT00507728|BG000|Baseline|Varenicline|"Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).~Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)"
10888719|NCT00507728|BG001|Baseline|Bupropion|"Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).~Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)"
10888720|NCT00507728|BG002|Baseline|Placebo|"Placebo by mouth for 12 weeks.~Placebo: Placebo by mouth for 12 weeks."
10888721|NCT00507728|BG003|Baseline|Total|Total of all reporting groups
10888722|NCT00507728|FG000|Participant Flow|Varenicline|"Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).~Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)"
10888723|NCT00507728|FG001|Participant Flow|Bupropion|"Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).~Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)"
10888724|NCT00507728|FG002|Participant Flow|Placebo|"Placebo by mouth for 12 weeks.~Placebo: Placebo by mouth for 12 weeks."
10888725|NCT00507728|OG000|Outcome|Varenicline|"Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).~Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)"
10888726|NCT00507728|OG001|Outcome|Bupropion|"Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).~Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)"
10888727|NCT00507728|OG002|Outcome|Placebo|"Placebo by mouth for 12 weeks.~Placebo: Placebo by mouth for 12 weeks."
10888728|NCT00507728|OG000|Outcome|Varenicline w/o DRD2 A1 Allele|Subjects in the Varenicline group not carrying the DRD2 A1 allele
10888729|NCT00507728|OG001|Outcome|Varenicline With DRD2 A1 Allele|Subjects in the Varenicline group carrying the DRD2 A1 allele
10888730|NCT00507728|OG002|Outcome|Bupropion w/o DRD2 A1 Allele|Subjects in the Bupropion group not carrying the DRD2 A1 allele
10888731|NCT00507728|OG003|Outcome|Bupropion With DRD2 A1 Allele|Subjects in the Bupropion group carrying the DRD2 A1 allele
10888732|NCT00507728|OG004|Outcome|Placebo w/o DRD2 A1 Allele|Subjects in the Placebo group not carrying the DRD2 A1 allele
10888733|NCT00507728|OG005|Outcome|Placebo With DRD2 A1 Allele|Subjects in the Bupropion group carrying the DRD2 A1 allele
10888734|NCT00507728|EG000|Reported Event|Varenicline|"Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).~Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)"
10888735|NCT00507728|EG001|Reported Event|Bupropion|"Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).~Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)"
10888736|NCT00507728|EG002|Reported Event|Placebo|"Placebo by mouth for 12 weeks.~Placebo: Placebo by mouth for 12 weeks."
10888737|NCT00507767|BG000|Baseline|Dasatinib|100 mg orally twice daily
10888738|NCT00507767|FG000|Participant Flow|Dasatinib|100 mg orally twice daily
10888739|NCT00507767|OG000|Outcome|Dasatinib|100 mg orally twice daily
10888740|NCT00507767|EG000|Reported Event|Dasatinib|100 mg orally twice daily
10888741|NCT00507819|BG000|Baseline|Study Population|Subjects who were randomized to receive either Sildenafil 20mg three times a day by mouth or Placebo three times a day by mouth.
10888742|NCT00507819|FG000|Participant Flow|Sildenafil, Then Placebo|Sildenafil will be given at a dose of 20 mg three times-a-day for six weeks followed by a six week washout period followed by placebo for an additional six weeks.
10888743|NCT00507819|FG001|Participant Flow|Placebo, Then Sildenafil|Placebo six weeks followed by a six week washout period followed by Sildenafil which will be given at a dose of 20 mg three times-a-day for six weeks
10888744|NCT00507819|OG000|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
10888745|NCT00507819|OG001|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
10888746|NCT00507819|EG000|Reported Event|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
10888747|NCT00507819|EG001|Reported Event|Placebo|Placebo was given by mouth three times a day for six weeks
10888748|NCT00508001|BG000|Baseline|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
10888749|NCT00508001|BG001|Baseline|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
10888750|NCT00508001|BG002|Baseline|Placebo|Placebo plus Best Support Care
10888751|NCT00508001|BG003|Baseline|Total|Total of all reporting groups
10888752|NCT00508001|FG000|Participant Flow|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
10888753|NCT00508001|FG001|Participant Flow|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
10888754|NCT00508001|FG002|Participant Flow|Placebo|Placebo plus Best Support Care
10888755|NCT00508001|OG000|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
10888756|NCT00508001|OG001|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
10888757|NCT00508001|OG002|Outcome|Placebo|Placebo plus Best Support Care
10888758|NCT00508001|EG000|Reported Event|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
10888759|NCT00508001|EG001|Reported Event|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
10888760|NCT00508001|EG002|Reported Event|Placebo|Placebo plus Best Support Care
10888761|NCT00508027|BG000|Baseline|Simvastatin, Dose Escalation|"There are no arms in this study. Simvastatin will be given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Simvastatin : Comparison of 3 dosages of simvastatin given in a dose-escalating fashion.~20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days."
10888762|NCT00508027|FG000|Participant Flow|Simvastatin, 3 Escalating Dose Groups|"Simvastatin was given in a dose-escalating fashion to 3 sequential dose groups:~dose level 1= 20 mg/day, dose level 2= 40 mg/day, dose level 3= 80 mg/day The number of subjects starting each dose level are new cohorts of subjects.~Determination of clinical safety in the first dose level group was required in order to begin enrollment in the second dose level group and ultimately the third dose group. Enrollment in the third dose level was discontinued early due to newly reported FDA warnings regarding high dose (80mg/day) simvastatin."
11170854|NCT01999114|EG004|Reported Event|Placebo|"Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets~Placebos (for TDS and for naltrexone and for moxifloxacin): Matching placebos"
10888763|NCT00508027|OG000|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
10888764|NCT00508027|OG001|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
10888765|NCT00508027|OG002|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; biomarker data were not collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
10888766|NCT00508027|OG002|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
10888767|NCT00508027|OG000|Outcome|Dose Level 1|All participants received 20mg simvastatin once daily
10888768|NCT00508027|OG001|Outcome|Dose Level 2|All participants received 40 mg of simvastatin once daily
10888769|NCT00508027|OG000|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
10888770|NCT00508027|OG002|Outcome|Simvastatin, Dose Level 3|"Subjects received 80 mg daily. Data collected for only 2 participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage"
10888771|NCT00508027|EG000|Reported Event|Simvastatin, Dose 1|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 1 = 20mg/day for 21 days, followed by 4-day drug taper."
10888772|NCT00508027|EG001|Reported Event|Simvastatin, Dose 2|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 2 = 40mg/day for 21 days, followed by a 4-day taper."
10888773|NCT00508027|EG002|Reported Event|Simvastatin, Dose 3|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 3 = 80mg/day for 21 days, followed by 4-day drug taper. Enrollment in this group discontinued early due to FDA warning re. high dose simvastatin"
10888774|NCT00508105|BG000|Baseline|Subscapularis Peel|"Detachment of the subscapularis tendon from its insertion on the lesser tuberosity the peel."
10888775|NCT00508105|BG001|Baseline|Osteotomy|osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
10888776|NCT00508105|BG002|Baseline|Total|Total of all reporting groups
10888777|NCT00508105|FG000|Participant Flow|Subscapularis Peel|"Detachment of the subscapularis tendon from its insertion on the lesser tuberosity the peel."
10888778|NCT00508105|FG001|Participant Flow|Osteotomy|osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
10888779|NCT00508105|OG000|Outcome|Osteotomy|
10888780|NCT00508105|OG001|Outcome|Subscapularis Peel|
10888781|NCT00508105|OG001|Outcome|Subscapularis Peel|"Detachment of the subscapularis tendon from its insertion on the lesser tuberosity the peel."
11170855|NCT01999192|BG000|Baseline|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
11170856|NCT01999192|BG001|Baseline|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
11170857|NCT01999192|BG002|Baseline|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
11170858|NCT01999192|BG003|Baseline|Placebo|Placebo s.c. weekly
11170859|NCT01999192|BG004|Baseline|Total|Total of all reporting groups
10888782|NCT00508105|EG000|Reported Event|Subscapularis Peel|tenotomy: This treatment group will undergo a technique that involves division of the tendon to gain access to the shoulder.
10888783|NCT00508105|EG001|Reported Event|Osteotomy|osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
10888784|NCT00508118|BG000|Baseline|Nicardipine|Nicardipine infusion before bypass
10888785|NCT00508118|BG001|Baseline|0.9% Saline|0.9% saline (placebo) before bypass
10888786|NCT00508118|BG002|Baseline|Total|Total of all reporting groups
10888787|NCT00508118|FG000|Participant Flow|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
10888788|NCT00508118|FG001|Participant Flow|0.9% Saline|0.9% saline (placebo) infusion before bypass
10888789|NCT00508118|OG000|Outcome|NICARDIPINE GROUP|Nicardipine prior to bypass
10888790|NCT00508118|OG000|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
10888791|NCT00508118|OG001|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
10888792|NCT00508118|EG000|Reported Event|Nicardipine|Nicardipine infusion before bypass
10888793|NCT00508118|EG001|Reported Event|0.9% Saline|0.9% saline (placebo) before bypass
10888794|NCT00508144|BG000|Baseline|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
10888795|NCT00508144|FG000|Participant Flow|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
10888796|NCT00508144|OG000|Outcome|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
10888797|NCT00508144|EG000|Reported Event|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
10888798|NCT00508157|BG000|Baseline|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks.
10888799|NCT00508157|BG001|Baseline|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
10888800|NCT00508157|BG002|Baseline|Total|Total of all reporting groups
10888801|NCT00508157|FG000|Participant Flow|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks.
10888802|NCT00508157|FG001|Participant Flow|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
10888803|NCT00508157|OG000|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks.
10888804|NCT00508157|OG001|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
10888805|NCT00508157|EG000|Reported Event|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
10888806|NCT00508157|EG001|Reported Event|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks.
10888807|NCT00508183|BG000|Baseline|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
10888808|NCT00508183|BG001|Baseline|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
10888809|NCT00508183|BG002|Baseline|Total|Total of all reporting groups
10888810|NCT00508183|FG000|Participant Flow|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
11170860|NCT01999192|FG000|Participant Flow|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
10888811|NCT00508183|FG001|Participant Flow|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
10888812|NCT00508183|OG000|Outcome|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
10888813|NCT00508183|OG001|Outcome|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
10888814|NCT00508183|EG000|Reported Event|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
11170861|NCT01999192|FG001|Participant Flow|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
11170862|NCT01999192|FG002|Participant Flow|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
11170863|NCT01999192|FG003|Participant Flow|Placebo|Placebo s.c. weekly
11170864|NCT01999192|OG000|Outcome|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
11170865|NCT01999192|OG001|Outcome|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
11170866|NCT01999192|OG002|Outcome|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
11170867|NCT01999192|OG003|Outcome|Placebo|Placebo s.c. weekly
11170868|NCT01999192|EG000|Reported Event|25mg Dose Level 1 Tregalizumab|Dose Level 1 Tregalizumab (25mg)
10888815|NCT00508183|EG001|Reported Event|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
10888816|NCT00508196|BG000|Baseline|All Participants|All subjects had the right ventricular lead implanted at the right ventricular apex. No subject was pacemaker dependent and the indication for pacing was intermittent sinus arrest or sinus bradycardia. Subjects with ongoing angina or heart failure symptoms, known AV node disease, bundle branch block, age >80 years, atrial fibrillation, or inability to exercise, were excluded.
10888817|NCT00508196|FG000|Participant Flow|RVP-Max First, Then RVP-Min|maximum RV pacing programmed (short AV delay) for 1 week, then at least 1 week washout, then minimum RV pacing (long AV delay)
10888818|NCT00508196|FG001|Participant Flow|RVP-Min First, Then RVP-Max|Minimum RV pacing programmed (long AV delay) for 1 week, then at least 1 week washout, then maximum RV pacing (short AV delay)
10888819|NCT00508196|OG000|Outcome|RVP-min|Minimal RV pacing , with long AV delay programmed in DDD mode
10888820|NCT00508196|OG001|Outcome|RVP-Max|Maximum RV pacing with short AV delay programmed in DDD mode
10888821|NCT00508196|EG000|Reported Event|RVP-min|Minimal RV pacing , with long AV delay programmed in DDD mode
10888822|NCT00508196|EG001|Reported Event|RVP-Max|Maximum RV pacing with short AV delay programmed in DDD mode
11170869|NCT01999192|EG001|Reported Event|100mg Dose Level 2 Tregalizumab|Dose Level 2 Tregalizumab (100mg)
11170870|NCT01999192|EG002|Reported Event|200mg Dose Level 3 Tregalizumab|Dose Level 3 Tregalizumab (200mg)
11170871|NCT01999192|EG003|Reported Event|Placebo|Placebo -
11170872|NCT01999218|BG000|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
11170873|NCT01999218|BG001|Baseline|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
11170874|NCT01999218|BG002|Baseline|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
11170875|NCT01999218|BG003|Baseline|Total|Total of all reporting groups
11170876|NCT01999218|FG000|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
11170877|NCT01999218|FG001|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
11170878|NCT01999218|FG002|Participant Flow|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
11170879|NCT01999218|OG000|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
11170880|NCT01999218|OG001|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
11170881|NCT01999218|OG002|Outcome|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
11170882|NCT01999218|EG000|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
11170883|NCT01999218|EG001|Reported Event|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
11170884|NCT01999218|EG002|Reported Event|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
11170885|NCT01999231|BG000|Baseline|1μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
11170886|NCT01999231|BG001|Baseline|5μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
11170887|NCT01999231|BG002|Baseline|10μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
11233159|NCT02424578|BG000|Baseline|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days~Diclofenac Capsules low dose"
11233160|NCT02424578|BG001|Baseline|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days~Diclofenac Capsules high dose"
10888823|NCT00508261|BG000|Baseline|Nimenrix + Infanrix-hexa Group|Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.
10888824|NCT00508261|BG001|Baseline|Nimenrix Group|Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.
10888825|NCT00508261|BG002|Baseline|Infanrix-Hexa Group|Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.
10888826|NCT00508261|BG003|Baseline|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
10888827|NCT00508261|BG004|Baseline|Total|Total of all reporting groups
10888828|NCT00508261|FG000|Participant Flow|Nimenrix + Infanrix-hexa Group|Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.
10888829|NCT00508261|FG001|Participant Flow|Nimenrix Group|Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.
10888830|NCT00508261|FG002|Participant Flow|Infanrix-Hexa Group|Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.
10888831|NCT00508261|FG003|Participant Flow|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
10888832|NCT00508261|OG000|Outcome|Nimenrix + Infanrix-hexa Group|Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.
10888833|NCT00508261|OG001|Outcome|Nimenrix Group|Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.
10888834|NCT00508261|OG001|Outcome|Infanrix-Hexa Group|Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.
10888835|NCT00508261|OG000|Outcome|Nimenrix + Infanrix-hexa Group|Subjects received concomitant administration of 1 dose of Nimenrix and Infanrix-hexa vaccines at Day 0.
10888836|NCT00508261|OG001|Outcome|Infanrix-Hexa Group|Subjects received a single dose of Infanrix-Hexa vaccine at Day 0, followed one month later by 1 dose of Nimenrix vaccine.
10888837|NCT00508261|OG002|Outcome|Infanrix-Hexa Group|Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.
10888838|NCT00508261|OG003|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
10888839|NCT00508261|OG000|Outcome|Nimenrix Group|Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.
10888840|NCT00508261|EG000|Reported Event|Nimenrix + Infanrix-hexa Group|Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.
10888841|NCT00508261|EG001|Reported Event|Nimenrix Group|Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.
10888842|NCT00508261|EG002|Reported Event|Infanrix-Hexa Group|Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.
10888843|NCT00508261|EG003|Reported Event|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
10888844|NCT00508274|BG000|Baseline|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
10888845|NCT00508274|FG000|Participant Flow|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
10888846|NCT00508274|OG000|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
10888847|NCT00508274|EG000|Reported Event|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
10888848|NCT00508300|BG000|Baseline|Epidural|epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.
10888849|NCT00508300|BG001|Baseline|Patient-controlled Analgesia|In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.
10888850|NCT00508300|BG002|Baseline|Total|Total of all reporting groups
10888851|NCT00508300|FG000|Participant Flow|Epidural|"Epidural Analgesia (Th 8-9)~Epidural analgesia: Thoracic epidural analgesia until day 2"
10888852|NCT00508300|FG001|Participant Flow|Patient-controlled Analgesia|"Patient controlled analgesia (morphine-based)~Patient controlled analgesia: Patient controlled analgesia (morphine-based)"
10888853|NCT00508300|OG000|Outcome|Epidural|epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.
10888854|NCT00508300|OG001|Outcome|Patient-controlled Analgesia|In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.
10888855|NCT00508300|EG000|Reported Event|Epidural|epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.
10888856|NCT00508300|EG001|Reported Event|Patient-controlled Analgesia|In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.
11233161|NCT02424578|BG002|Baseline|Total|Total of all reporting groups
10888857|NCT00508391|BG000|Baseline|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
10888858|NCT00508391|BG001|Baseline|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
10888859|NCT00508391|BG002|Baseline|Total|Total of all reporting groups
10888860|NCT00508391|FG000|Participant Flow|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
10888861|NCT00508391|FG001|Participant Flow|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
10888862|NCT00508391|OG000|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
10888863|NCT00508391|OG001|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
10888864|NCT00508391|OG002|Outcome|Total Subjects|Total subjects enrolled in study.
10888865|NCT00508391|EG000|Reported Event|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
10888866|NCT00508391|EG001|Reported Event|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
10888867|NCT00508391|EG002|Reported Event|Total Subjects|Total subjects enrolled in study.
10888868|NCT00508404|BG000|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
10888869|NCT00508404|FG000|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
10888870|NCT00508404|OG000|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
10888871|NCT00508404|OG001|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
10888872|NCT00508404|EG000|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
10888873|NCT00508469|BG000|Baseline|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
10888874|NCT00508469|BG001|Baseline|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
10888875|NCT00508469|BG002|Baseline|Total|Total of all reporting groups
10888876|NCT00508469|FG000|Participant Flow|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
10888877|NCT00508469|FG001|Participant Flow|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
10888878|NCT00508469|OG000|Outcome|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
10888879|NCT00508469|OG001|Outcome|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
10888880|NCT00508469|EG000|Reported Event|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
10888881|NCT00508469|EG001|Reported Event|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
10888882|NCT00508482|BG000|Baseline|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
10888883|NCT00508482|BG001|Baseline|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
10888884|NCT00508482|BG002|Baseline|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
10888885|NCT00508482|BG003|Baseline|Total|Total of all reporting groups
11233162|NCT02424578|FG000|Participant Flow|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days~Diclofenac Capsules low dose"
10851083|NCT01650285|OG000|Outcome|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
10888886|NCT00508482|FG000|Participant Flow|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
10888887|NCT00508482|FG001|Participant Flow|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
10888888|NCT00508482|FG002|Participant Flow|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
10888889|NCT00508482|OG000|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
10888890|NCT00508482|OG001|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
10888891|NCT00508482|OG002|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
10888892|NCT00508482|OG001|Outcome|Shallow Needling Group|"Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.~."
10888893|NCT00508482|EG000|Reported Event|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
10888894|NCT00508482|EG001|Reported Event|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
10888895|NCT00508482|EG002|Reported Event|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
10888896|NCT00508521|BG000|Baseline|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
10888897|NCT00508521|FG000|Participant Flow|FES and Motor Learning Training Group|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
10888898|NCT00508521|OG000|Outcome|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
10888899|NCT00508521|EG000|Reported Event|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
10888900|NCT00508651|BG000|Baseline|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
10888901|NCT00508651|BG001|Baseline|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
10888902|NCT00508651|BG002|Baseline|Total|Total of all reporting groups
10888903|NCT00508651|FG000|Participant Flow|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
10888904|NCT00508651|FG001|Participant Flow|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
11170888|NCT01999231|BG003|Baseline|20μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
10888905|NCT00508651|OG000|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
10888906|NCT00508651|OG001|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
10888907|NCT00508651|EG000|Reported Event|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
10888908|NCT00508651|EG001|Reported Event|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
10888909|NCT00508716|BG000|Baseline|Usual Care|CHF Education by usual Nurse without teach-back or Video.
10888910|NCT00508716|BG001|Baseline|Tailored Intervention for Patients With Low Health Literacy an|"Tailored Intervention for patients with low health literacy and nurse-directed teachback~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
10888911|NCT00508716|BG002|Baseline|Total|Total of all reporting groups
10888912|NCT00508716|FG000|Participant Flow|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
10888913|NCT00508716|FG001|Participant Flow|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
10888914|NCT00508716|OG000|Outcome|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
10888915|NCT00508716|OG001|Outcome|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
10888916|NCT00508716|EG000|Reported Event|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
10888917|NCT00508716|EG001|Reported Event|Teilored Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
10888918|NCT00508742|BG000|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10888919|NCT00508742|BG001|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10888920|NCT00508742|BG002|Baseline|Total|Total of all reporting groups
10888921|NCT00508742|FG000|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10888922|NCT00508742|FG001|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10888923|NCT00508742|OG000|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10888924|NCT00508742|OG001|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10888925|NCT00508742|EG000|Reported Event|Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
10888926|NCT00508742|EG001|Reported Event|Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
10888927|NCT00508742|EG002|Reported Event|After Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
10888928|NCT00508742|EG003|Reported Event|After Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
10888929|NCT00508742|EG004|Reported Event|Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
10888930|NCT00508742|EG005|Reported Event|Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL dose intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
10888931|NCT00508742|EG006|Reported Event|After Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
11170889|NCT01999231|BG004|Baseline|Total|Total of all reporting groups
10888932|NCT00508742|EG007|Reported Event|After Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
10888933|NCT00508755|BG000|Baseline|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
10888934|NCT00508755|FG000|Participant Flow|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
10888935|NCT00508755|OG000|Outcome|Gait Robot-alone Training|The 6 study subjects with chronic stroke ambulated in the Gait Robot, and observational gait analysis was performed.
10888936|NCT00508755|OG001|Outcome|FES-Alone|The 6 study subjects with chronic stroke ambulated with FES, and observational gait analysis was performed.
10888937|NCT00508755|OG002|Outcome|Combined Gait Robot and FES|The 6 study subjects with chronic stroke ambulated with combination Gait Robot and FES, and observational gait analysis was performed.
10888938|NCT00508755|EG000|Reported Event|Gait Training After Stroke|subjects with Chronic stroke (.5-1.5 years post stroke)received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and Gait Robot.
10888939|NCT00508820|BG000|Baseline|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
10888940|NCT00508820|BG001|Baseline|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
10888941|NCT00508820|BG002|Baseline|Total|Total of all reporting groups
10888942|NCT00508820|FG000|Participant Flow|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
10888943|NCT00508820|FG001|Participant Flow|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
10888944|NCT00508820|OG000|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
10888945|NCT00508820|OG001|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
10888946|NCT00508820|EG000|Reported Event|Romiplostim Cohort 1|
10888947|NCT00508820|EG001|Reported Event|Romiplostim Cohort 2|
10888948|NCT00508924|BG000|Baseline|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888949|NCT00508924|BG001|Baseline|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888950|NCT00508924|BG002|Baseline|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888951|NCT00508924|BG003|Baseline|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
10888952|NCT00508924|BG004|Baseline|Total|Total of all reporting groups
10888953|NCT00508924|FG000|Participant Flow|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888954|NCT00508924|FG001|Participant Flow|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888955|NCT00508924|FG002|Participant Flow|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888956|NCT00508924|FG003|Participant Flow|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
10888957|NCT00508924|OG000|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888958|NCT00508924|OG001|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888959|NCT00508924|OG002|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888960|NCT00508924|OG003|Outcome|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
10888961|NCT00508924|EG000|Reported Event|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888962|NCT00508924|EG001|Reported Event|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888963|NCT00508924|EG002|Reported Event|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
10888964|NCT00508924|EG003|Reported Event|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
10888965|NCT00509002|BG000|Baseline|Gefitinib|Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
10888966|NCT00509002|FG000|Participant Flow|Gefitinib|Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
11233163|NCT02424578|FG001|Participant Flow|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days~Diclofenac Capsules high dose"
10888967|NCT00509002|OG000|Outcome|Gefitinib|Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
10888968|NCT00509002|EG000|Reported Event|Gefitinib|Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
10888969|NCT00509028|BG000|Baseline|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
10888970|NCT00509028|BG001|Baseline|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
10888971|NCT00509028|BG002|Baseline|Total|Total of all reporting groups
10888972|NCT00509028|FG000|Participant Flow|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
10888973|NCT00509028|FG001|Participant Flow|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
10888974|NCT00509028|OG000|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
10888975|NCT00509028|OG001|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
10888976|NCT00509028|EG000|Reported Event|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
10888977|NCT00509028|EG001|Reported Event|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
10888978|NCT00509041|BG000|Baseline|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
10888979|NCT00509041|FG000|Participant Flow|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
10888980|NCT00509041|OG000|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
10888981|NCT00509041|EG000|Reported Event|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
10888982|NCT00509067|BG000|Baseline|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
10888983|NCT00509067|BG001|Baseline|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
10888984|NCT00509067|BG002|Baseline|Total|Total of all reporting groups
10888985|NCT00509067|FG000|Participant Flow|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
10888986|NCT00509067|FG001|Participant Flow|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
10888987|NCT00509067|OG000|Outcome|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
10888988|NCT00509067|OG001|Outcome|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
10888989|NCT00509067|OG000|Outcome|Galantamine and CDP-choline Group|"Participants assigned to galantamine and CDP-choline~Galantamine: Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.~CDP-choline: CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.~risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, zipr"
10888990|NCT00509067|OG001|Outcome|Placebo Group|"Participants assigned to placebo~Placebo: The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.~risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment."
10888991|NCT00509067|OG000|Outcome|Galantamine and CDP-choline Group|"Participants assigned to receive galantamine/CDP-choline~Galantamine: Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.~CDP-choline: CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.~risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, zipr"
10888992|NCT00509067|OG001|Outcome|Placebo Group|"Participants assigned to receive placebo~Placebo: The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.~risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment."
10888993|NCT00509067|EG000|Reported Event|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
10888994|NCT00509067|EG001|Reported Event|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
10914718|NCT00632619|BG000|Baseline|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
11233164|NCT02424578|OG000|Outcome|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days~Diclofenac Capsules low dose"
10888995|NCT00509093|BG000|Baseline|Imatinib Mesylate|"Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.~Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.~Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.~PCR: AF1q gene analysis (on bone marrow aspirate)~Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a"
10888996|NCT00509093|FG000|Participant Flow|Imatinib Mesylate|"Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.~Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.~Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.~PCR: AF1q gene analysis (on bone marrow aspirate)~Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a"
10888997|NCT00509093|OG000|Outcome|Imatinib Mesylate|"Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.~Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.~Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.~PCR: AF1q gene analysis (on bone marrow aspirate)~Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a"
10888998|NCT00509093|EG000|Reported Event|Imatinib Mesylate|"Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.~Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.~Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.~PCR: AF1q gene analysis (on bone marrow aspirate)~Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a"
10888999|NCT00509106|BG000|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
10889000|NCT00509106|BG001|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
10889001|NCT00509106|BG002|Baseline|Total|Total of all reporting groups
10889002|NCT00509106|FG000|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
10889003|NCT00509106|FG001|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
10889004|NCT00509106|OG000|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
10889005|NCT00509106|OG001|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
10889006|NCT00509106|EG000|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
10889007|NCT00509106|EG001|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
11233165|NCT02424578|OG001|Outcome|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days~Diclofenac Capsules high dose"
11233166|NCT02424578|EG000|Reported Event|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days~Diclofenac Capsules low dose"
10889008|NCT00509145|BG000|Baseline|Laquinimod|Laquinimod 0.6 mg capsule taken orally once a day
10889009|NCT00509145|BG001|Baseline|Placebo|Matching placebo capsule taken orally once a day
10889010|NCT00509145|BG002|Baseline|Total|Total of all reporting groups
10889011|NCT00509145|FG000|Participant Flow|Laquinimod|Laquinimod 0.6 mg capsule taken orally once a day
10889012|NCT00509145|FG001|Participant Flow|Placebo|Matching placebo capsule taken orally once a day
10889013|NCT00509145|OG000|Outcome|Laquinimod|Laquinimod 0.6 mg capsule taken orally once a day
10889014|NCT00509145|OG001|Outcome|Placebo|Matching placebo capsule taken orally once a day
10889015|NCT00509145|EG000|Reported Event|Laquinimod 0.6 mg|Laquinimod 0.6 mg capsule taken orally once a day
10889016|NCT00509145|EG001|Reported Event|Placebo|Matching placebo capsule taken orally once a day
10889017|NCT00509171|BG000|Baseline|1-Standard Reamer|"Standard reamer~Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures"
10889018|NCT00509171|BG001|Baseline|2-Use of the Reamer-Irrigator Aspirator|"Use of the Reamer-Irrigator Aspirator~Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures"
11233167|NCT02424578|EG001|Reported Event|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days~Diclofenac Capsules high dose"
11233168|NCT02424591|BG000|Baseline|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
10889019|NCT00509171|BG002|Baseline|Total|Total of all reporting groups
10889020|NCT00509171|FG000|Participant Flow|1-Standard Reamer|"Standard reamer~Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures"
10889021|NCT00509171|FG001|Participant Flow|2-Use of the Reamer-Irrigator Aspirator|"Use of the Reamer-Irrigator Aspirator~Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures"
10889022|NCT00509171|OG000|Outcome|1-Standard Reamer|"Standard reamer~Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures"
10889023|NCT00509171|OG001|Outcome|2-Use of the Reamer-Irrigator Aspirator|"Use of the Reamer-Irrigator Aspirator~Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures"
10889024|NCT00509171|EG000|Reported Event|1-Standard Reamer|"Standard reamer~Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures"
10889025|NCT00509171|EG001|Reported Event|2-Use of the Reamer-Irrigator Aspirator|"Use of the Reamer-Irrigator Aspirator~Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures"
10889026|NCT00509197|BG000|Baseline|Fluticasone 500 mcg Bid|Treatment with inhaled corticosteroids
10889027|NCT00509197|BG001|Baseline|Placebo|Treatment with placebo
10889028|NCT00509197|BG002|Baseline|Total|Total of all reporting groups
11174199|NCT02020252|FG000|Participant Flow|Touchscreen Participants|"New lung, gastric and pancreatic cancer patients presenting to the University of Chicago outpatient oncology clinics, a large research institution located on Chicago's Southside, were identified for study accrual, using the electronic scheduling system.~Testing an interactive technology in a diverse health literary population: Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. We tested an interactive technology designed for patients with diverse health literacy skills aimed at improving patient receptiveness, willingness, knowledge, self-efficacy and positive attitudes regarding clinical trials."
10889029|NCT00509197|FG000|Participant Flow|Fluticasone 500 mcg Bid|Treatment with Inhaled Corticosteroids
10889030|NCT00509197|FG001|Participant Flow|Placebo|treatment with placebo
10889031|NCT00509197|OG000|Outcome|Fluticasone|Treatment with inhaled corticosteroids
10889032|NCT00509197|OG001|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
10889033|NCT00509197|OG000|Outcome|Fluticasone|Treatment with Fluticasone
10889034|NCT00509197|OG001|Outcome|Placebo|Treatment with placebo
10889035|NCT00509197|EG000|Reported Event|Fluticasone 500 mcg Bid|Treatment with inhaled Corticosteroids
10889036|NCT00509197|EG001|Reported Event|Placebo|Treatment with placebo
10889037|NCT00509223|BG000|Baseline|Lifestyle Counseling With PAP Therapy|
10889038|NCT00509223|BG001|Baseline|Lifestyle Counseling|
10889039|NCT00509223|BG002|Baseline|Total|Total of all reporting groups
10889040|NCT00509223|FG000|Participant Flow|Group 1|"Lifestyle counseling with Positive Airway Pressure (PAP) therapy~Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.~Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep."
10889041|NCT00509223|FG001|Participant Flow|Group 2|"Lifestyle counseling without Positive Airway Pressure (PAP) therapy~Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations."
10889042|NCT00509223|OG000|Outcome|Lifestyle Counseling With PAP Therapy|
10889043|NCT00509223|OG001|Outcome|Lifestyle Counseling|
10889044|NCT00509223|EG000|Reported Event|Lifestyle Counseling|
10889045|NCT00509223|EG001|Reported Event|Lifestyle Counseling With PAP Therapy|
10889046|NCT00509236|BG000|Baseline|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
10889047|NCT00509236|BG001|Baseline|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
10889048|NCT00509236|BG002|Baseline|Total|Total of all reporting groups
10889049|NCT00509236|FG000|Participant Flow|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
10889050|NCT00509236|FG001|Participant Flow|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
10889051|NCT00509236|OG000|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
10889052|NCT00509236|OG001|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
10889053|NCT00509236|EG000|Reported Event|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
10889054|NCT00509236|EG001|Reported Event|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
10889055|NCT00509249|BG000|Baseline|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10889056|NCT00509249|FG000|Participant Flow|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10889057|NCT00509249|OG000|Outcome|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10889058|NCT00509249|EG000|Reported Event|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10889059|NCT00509262|BG000|Baseline|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
10889060|NCT00509262|BG001|Baseline|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
10889061|NCT00509262|BG002|Baseline|Total|Total of all reporting groups
10889062|NCT00509262|FG000|Participant Flow|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
10889063|NCT00509262|FG001|Participant Flow|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
10889064|NCT00509262|OG000|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
10889065|NCT00509262|OG001|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
10889066|NCT00509262|EG000|Reported Event|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
10889067|NCT00509262|EG001|Reported Event|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
10889068|NCT00509288|BG000|Baseline|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
10889069|NCT00509288|BG001|Baseline|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
10889070|NCT00509288|BG002|Baseline|Total|Total of all reporting groups
10889071|NCT00509288|FG000|Participant Flow|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
10889072|NCT00509288|FG001|Participant Flow|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
11233169|NCT02424591|BG001|Baseline|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
10889073|NCT00509288|OG000|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
10889074|NCT00509288|OG001|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
10889075|NCT00509288|EG000|Reported Event|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
10889076|NCT00509288|EG001|Reported Event|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
10889077|NCT00509366|BG000|Baseline|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/gemcitabine protocol-based treatment consistent with histology, and treated during the course of the study.
10889078|NCT00509366|BG001|Baseline|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/pemetrexed protocol-based treatment consistent with histology, and treated during the course of the study.
10889079|NCT00509366|BG002|Baseline|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to cisplatin/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
10889080|NCT00509366|BG003|Baseline|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to docetaxel/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
10889081|NCT00509366|BG004|Baseline|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis or those who were assigned treatment but not treated after reevaluation of their eligibility.
10889082|NCT00509366|BG005|Baseline|Total|Total of all reporting groups
10889083|NCT00509366|FG000|Participant Flow|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure.
10889084|NCT00509366|FG001|Participant Flow|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure.
10889085|NCT00509366|FG002|Participant Flow|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure.
10889086|NCT00509366|FG003|Participant Flow|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology.
10889087|NCT00509366|FG004|Participant Flow|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
11233170|NCT02424591|BG002|Baseline|Total|Total of all reporting groups
10851084|NCT01650285|EG000|Reported Event|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
11233171|NCT02424591|FG000|Participant Flow|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
11233172|NCT02424591|FG001|Participant Flow|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
10889088|NCT00509366|OG000|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
10851085|NCT01083771|BG000|Baseline|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
10851086|NCT01083771|FG000|Participant Flow|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
10851087|NCT01083771|OG000|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
10851088|NCT01083771|EG000|Reported Event|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
10851089|NCT00743197|BG000|Baseline|Usual Care Group|USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
10851090|NCT00743197|BG001|Baseline|Medical Treatment Group|TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
10851091|NCT00743197|BG002|Baseline|Total|Total of all reporting groups
10851092|NCT00743197|FG000|Participant Flow|Usual Care Group|USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
10851093|NCT00743197|FG001|Participant Flow|Medical Treatment Group|TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
10851094|NCT00743197|OG000|Outcome|Usual Care Group|
10851095|NCT00743197|OG001|Outcome|Medical Treatment Group|
10851096|NCT00743197|EG000|Reported Event|Usual Care Group|USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
10851097|NCT00743197|EG001|Reported Event|Medical Treatment Group|TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
10851098|NCT00304915|BG000|Baseline|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
10851099|NCT00304915|BG001|Baseline|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
10851100|NCT00304915|BG002|Baseline|Total|Total of all reporting groups
10851101|NCT00304915|FG000|Participant Flow|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in VA electronic medical record. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
10851102|NCT00304915|FG001|Participant Flow|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same 9-item Patient Health Questionnaire (PHQ-9) screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
10851103|NCT00304915|OG000|Outcome|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
10851104|NCT00304915|OG001|Outcome|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
10851105|NCT00304915|EG000|Reported Event|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
10851106|NCT00304915|EG001|Reported Event|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
10851107|NCT00304954|BG000|Baseline|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
10851108|NCT00304954|BG001|Baseline|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
10851109|NCT00304954|BG002|Baseline|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
10851110|NCT00304954|BG003|Baseline|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
10851111|NCT00304954|BG004|Baseline|Total|Total of all reporting groups
10889089|NCT00509366|OG000|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive (cisplatin/pemetrexed or cisplatin/gemcitabine) and resistant (pemetrexed/gemcitabine or docetaxel/gemcitabine) arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
10889090|NCT00509366|OG000|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study.
10889091|NCT00509366|EG000|Reported Event|Cisplatin Sensitive (Pre-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated 1/25/2010.
10889092|NCT00509366|EG001|Reported Event|Cisplatin Sensitive (Post-Amendment)|Post-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
10889093|NCT00509366|EG002|Reported Event|Cisplatin Resistant (Pre-Amendment)|Pre-amendment cisplatin resistant refers to patients who experienced adverse events and treated with cisplatin-resistant protocol based therapy per the amendment dated 1/25/2010.
10889094|NCT00509366|EG003|Reported Event|Cisplatin Resistant (Post-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
10889095|NCT00509366|EG004|Reported Event|Screen Failure|Screen failures constitute patients who were registered into the study and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not enrolled to genomics-directed, protocol-based therapy. From the participant flow, 9 of the 54 screen failures did not have adverse event follow-up, resulting in a final count of 45 screen failures with adverse event follow-up.
10889096|NCT00509392|BG000|Baseline|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
10889097|NCT00509392|BG001|Baseline|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
10889098|NCT00509392|BG002|Baseline|Total|Total of all reporting groups
10889099|NCT00509392|FG000|Participant Flow|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
10889100|NCT00509392|FG001|Participant Flow|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
10889101|NCT00509392|FG002|Participant Flow|RF / EVLA|Bilateral treatment where one limb is treated with RFA and the contralateral limb is treated with EVL
10889102|NCT00509392|OG000|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
10889103|NCT00509392|OG001|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
10889104|NCT00509392|EG000|Reported Event|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
10889105|NCT00509392|EG001|Reported Event|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
10889106|NCT00509496|BG000|Baseline|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
10889107|NCT00509496|BG001|Baseline|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
10889108|NCT00509496|BG002|Baseline|Total|Total of all reporting groups
10889109|NCT00509496|FG000|Participant Flow|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
10889110|NCT00509496|FG001|Participant Flow|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
10889111|NCT00509496|OG000|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
11233173|NCT02424591|OG000|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
11233174|NCT02424591|OG001|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
10889112|NCT00509496|OG001|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
10889113|NCT00509496|EG000|Reported Event|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
10889114|NCT00509496|EG001|Reported Event|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
10889115|NCT00509587|BG000|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10889116|NCT00509587|FG000|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10889117|NCT00509587|OG000|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10889118|NCT00509587|EG000|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10889119|NCT00509665|BG000|Baseline|Gemcitabine+Doxorubicin|"doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.~gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle"
10889120|NCT00509665|FG000|Participant Flow|Gemcitabine+Doxorubicin|"doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.~gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle"
10889121|NCT00509665|OG000|Outcome|Gemcitabine+Doxorubicin|"doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.~gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle"
10889122|NCT00509665|EG000|Reported Event|Gemcitabine+Doxorubicin|"doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.~gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle"
10889123|NCT00509769|BG000|Baseline|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
11233175|NCT02424591|EG000|Reported Event|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
10889124|NCT00509769|FG000|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
10889125|NCT00509769|OG000|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
10889126|NCT00509769|EG000|Reported Event|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
10889127|NCT00509795|BG000|Baseline|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
10889128|NCT00509795|BG001|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
10889129|NCT00509795|BG002|Baseline|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
10889130|NCT00509795|BG003|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
10889131|NCT00509795|BG004|Baseline|Total|Total of all reporting groups
10889132|NCT00509795|FG000|Participant Flow|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.
10889133|NCT00509795|FG001|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
10889134|NCT00509795|FG002|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
11233176|NCT02424591|EG001|Reported Event|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
10889135|NCT00509795|FG003|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.
10889136|NCT00509795|OG000|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
10889137|NCT00509795|OG001|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
10889138|NCT00509795|OG002|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
10889139|NCT00509795|OG003|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
10889140|NCT00509795|OG004|Outcome|Total|
10889141|NCT00509795|EG000|Reported Event|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of ranibizumab (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10889142|NCT00509795|EG001|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10889143|NCT00509795|EG002|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10889144|NCT00509795|EG003|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10889145|NCT00509821|BG000|Baseline|Enzastaurin Once Daily (QD)|Enzastaurin given orally (PO) once daily (QD). 1125 mg loading dose D(-)7 then 500 mg PO,QD with concomitant radiotherapy.
10889146|NCT00509821|BG001|Baseline|Enzastaurin Twice Daily (BID)|Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO.
10889147|NCT00509821|BG002|Baseline|Total|Total of all reporting groups
10889148|NCT00509821|FG000|Participant Flow|Enzastaurin Once Daily (QD)|A loading dose of 1125 mg of enzastaurin administered orally (PO) on Day -7 (3 tablets of 125 mg, given 3 times daily (TID) followed by 500 mg once daily (QD)
10889149|NCT00509821|FG001|Participant Flow|Enzastaurin Twice Daily (BID)|A loading dose of 1125 mg of enzastaurin administered PO Day -7 (TID); the dose from Day -6 until study end was 500 mg, given in 2 daily PO (BID) doses of 250 mg
10889150|NCT00509821|OG000|Outcome|Enzastaurin Twice Daily (BID)|Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO.
10889151|NCT00509821|EG000|Reported Event|Induction Enzastaurin Once Daily (QD)|A loading dose of 1125 mg of enzastaurin administered orally (PO) on Day -7 (3 tablets of 125 mg, given 3 times daily (TID) followed by 500 mg once daily (QD)
10889152|NCT00509821|EG001|Reported Event|Induction Enzastaurin Twice Daily (BID)|A loading dose of 1125 mg of enzastaurin administered PO Day -7 (TID); the dose from Day -6 until study end was 500 mg, given in 2 daily PO (BID) doses of 250 mg
10889153|NCT00509821|EG002|Reported Event|Radiation Enzastaurin Once Daily (QD)|Enzastaurin 500 mg administered PO QD.
10889154|NCT00509821|EG003|Reported Event|Radiation Enzastaurin Twice Daily (BID)|Enzastaurin 500 mg administered PO BID.
10889155|NCT00509821|EG004|Reported Event|Maintenance Enzastaurin Once Daily (QD)|Enzastaurin 500 mg administered PO, QD continued until progression or unacceptable adverse events (AEs)
10889156|NCT00509821|EG005|Reported Event|Maintenance Enzastaurin Twice Daily (BID)|Enzastaurin 500 mg administered PO, BID continued until progression or unacceptable adverse events (AEs)
10889157|NCT00509821|EG006|Reported Event|Enzastaurin Once Daily (QD) Entire Study|A safety follow-up performed after end of enzastaurin treatment for all participants who received at least 1 dose of study drug.
10889158|NCT00509821|EG007|Reported Event|Enzastaurin Twice Daily (BID) Entire Study|A safety follow-up performed after end of enzastaurin treatment for all participants who received at least 1 dose of study drug.
10889159|NCT00509873|BG000|Baseline|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
10889160|NCT00509873|BG001|Baseline|Placebo Eye Drops|Placebo eye drops
10889161|NCT00509873|BG002|Baseline|Total|Total of all reporting groups
10889162|NCT00509873|FG000|Participant Flow|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
10889163|NCT00509873|FG001|Participant Flow|Placebo Eye Drops|Placebo eye drops
10889164|NCT00509873|OG000|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
10889165|NCT00509873|OG001|Outcome|Placebo Eye Drops|Placebo eye drops
10889166|NCT00509873|EG000|Reported Event|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
10889167|NCT00509873|EG001|Reported Event|Placebo Eye Drops|Placebo eye drops
11170890|NCT01999231|FG000|Participant Flow|1μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 1μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 5μg/ml ESAT6-CFP10 groups ."
11170891|NCT01999231|FG001|Participant Flow|5μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 5μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 10μg/ml ESAT6-CFP10 groups ."
11170892|NCT01999231|FG002|Participant Flow|10μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 10μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 20μg/ml ESAT6-CFP10 groups ."
11335581|NCT03552757|EG000|Reported Event|Semaglutide 1.0 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
10889168|NCT00509899|BG000|Baseline|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
10889169|NCT00509899|BG001|Baseline|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
10889170|NCT00509899|BG002|Baseline|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889171|NCT00509899|BG003|Baseline|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889172|NCT00509899|BG004|Baseline|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
10889173|NCT00509899|BG005|Baseline|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889174|NCT00509899|BG006|Baseline|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889175|NCT00509899|BG007|Baseline|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889176|NCT00509899|BG008|Baseline|Total|Total of all reporting groups
10889177|NCT00509899|FG000|Participant Flow|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
10889178|NCT00509899|FG001|Participant Flow|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
10889179|NCT00509899|FG002|Participant Flow|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889180|NCT00509899|FG003|Participant Flow|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889181|NCT00509899|FG004|Participant Flow|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
10889182|NCT00509899|FG005|Participant Flow|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889183|NCT00509899|FG006|Participant Flow|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889184|NCT00509899|FG007|Participant Flow|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889185|NCT00509899|OG000|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
10889186|NCT00509899|OG001|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
10889187|NCT00509899|OG002|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889188|NCT00509899|OG003|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889189|NCT00509899|OG004|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
11335582|NCT03552757|EG001|Reported Event|Semaglutide 2.4 mg|Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
10889190|NCT00509899|OG003|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
10851112|NCT00304954|FG000|Participant Flow|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
10851113|NCT00304954|FG001|Participant Flow|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
11335583|NCT03552757|EG002|Reported Event|Placebo|Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
10851114|NCT00304954|FG002|Participant Flow|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
10851115|NCT00304954|FG003|Participant Flow|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
10851116|NCT00304954|OG000|Outcome|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
10851117|NCT00304954|OG001|Outcome|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
10851118|NCT00304954|OG002|Outcome|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
10851119|NCT00304954|OG003|Outcome|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
10851120|NCT00304954|OG000|Outcome|Baseline Vision - Study Eye|
10851121|NCT00304954|OG001|Outcome|Sixth-Month Vision - Study Eye|
10851122|NCT00304954|OG002|Outcome|Baseline Vision - Fellow Eye|
10851123|NCT00304954|OG003|Outcome|Sixth-Month Vision - Fellow Eye|
10851124|NCT00304954|OG000|Outcome|Baseline OCT - Study Eye|
10851125|NCT00304954|OG001|Outcome|Sixth-Month OCT - Study Eye|
10851126|NCT00304954|OG002|Outcome|Baseline OCT - Fellow Eye|
10851127|NCT00304954|OG003|Outcome|Sixth-Month OCT - Fellow Eye|
10851128|NCT00304954|EG000|Reported Event|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
10851129|NCT00304954|EG001|Reported Event|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
10851130|NCT00304954|EG002|Reported Event|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
10851131|NCT00304954|EG003|Reported Event|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
10851132|NCT00305006|BG000|Baseline|CIMT|Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.
10851133|NCT00305006|BG001|Baseline|HABIT|Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.
10851134|NCT00305006|BG002|Baseline|Total|Total of all reporting groups
10851135|NCT00305006|FG000|Participant Flow|CIMT|Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.
10851136|NCT00305006|FG001|Participant Flow|HABIT|Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.
10851137|NCT00305006|OG000|Outcome|CIMT|Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.
10851138|NCT00305006|OG001|Outcome|HABIT|Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.
10851139|NCT00305006|EG000|Reported Event|CIMT|Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.
10851140|NCT00305006|EG001|Reported Event|HABIT|Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.
10851141|NCT00305058|BG000|Baseline|Morphine|0.05 mg/kg IV morphine
10851142|NCT00305058|BG001|Baseline|Hydromorphone|0.0075 mg/kg IV hydromorphone
10851143|NCT00305058|BG002|Baseline|Total|Total of all reporting groups
10851144|NCT00305058|FG000|Participant Flow|Morphine|0.05 mg/kg IV morphine
10851145|NCT00305058|FG001|Participant Flow|Hydromorphone|0.0075 mg/kg IV hydromorphone
10851146|NCT00305058|OG000|Outcome|Morphine|0.05 mg/kg IV morphine
10851147|NCT00305058|OG001|Outcome|Hydromorphone|0.0075 mg/kg IV hydromorphone
10851148|NCT00305058|EG000|Reported Event|Morphine|0.05 mg/kg IV morphine
10851149|NCT00305058|EG001|Reported Event|Hydromorphone|0.0075 mg/kg IV hydromorphone
10851150|NCT00305084|BG000|Baseline|Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2|"NGR-hTNF: 0.2 μg/m^2as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 60 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851151|NCT00305084|BG001|Baseline|Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.2 μg/m^2as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851152|NCT00305084|BG002|Baseline|Cohort 3: NGRhTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.4 μg/m^2as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10889191|NCT00509899|OG000|Outcome|All Participants|All participants received ruxolitinib at varying initial dose and regimen. Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889192|NCT00509899|EG000|Reported Event|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
10889193|NCT00509899|EG001|Reported Event|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
10889194|NCT00509899|EG002|Reported Event|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889195|NCT00509899|EG003|Reported Event|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
10889196|NCT00509899|EG004|Reported Event|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
10889197|NCT00509925|BG000|Baseline|Entire Trial Population|The entire trial population includes groups randomised to receive either insulin detemir or insulin NPH as their first treatment.
10889198|NCT00509925|FG000|Participant Flow|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
10889199|NCT00509925|FG001|Participant Flow|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
10889200|NCT00509925|OG000|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
10889201|NCT00509925|OG001|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
10889202|NCT00509925|OG000|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
10889203|NCT00509925|OG001|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
10889204|NCT00509925|EG000|Reported Event|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
10889205|NCT00509925|EG001|Reported Event|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
10889206|NCT00510068|BG000|Baseline|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
10889207|NCT00510068|BG001|Baseline|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
10889208|NCT00510068|BG002|Baseline|Total|Total of all reporting groups
10889209|NCT00510068|FG000|Participant Flow|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
10889210|NCT00510068|FG001|Participant Flow|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
10889211|NCT00510068|OG000|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
10889212|NCT00510068|OG001|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
10889213|NCT00510068|OG001|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
10889214|NCT00510068|EG000|Reported Event|Everolimus 10mg/Day|Afinitor DB: Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
10889215|NCT00510068|EG001|Reported Event|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
10889216|NCT00510068|EG002|Reported Event|Open Label - Everolimus 10mg|Afinitor OL (for data collected in the open-label period of the study): The open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.
10889217|NCT00510146|BG000|Baseline|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
10889218|NCT00510146|BG001|Baseline|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
10889219|NCT00510146|BG002|Baseline|Total|Total of all reporting groups
10889220|NCT00510146|FG000|Participant Flow|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
10889221|NCT00510146|FG001|Participant Flow|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
10889222|NCT00510146|OG000|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
10889223|NCT00510146|OG001|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
10889224|NCT00510146|OG000|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
10889225|NCT00510146|EG000|Reported Event|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg. which is increased to 10 mg. per day no later than 3-7 days after Visit 2. Subsequent dose increases above 10 mg. (up to a maximum of 20 mg per day) are permitted in 5 mg. per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg. requires study discontinuation.
10889226|NCT00510146|EG001|Reported Event|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
10889227|NCT00510146|EG002|Reported Event|Olanzapine (Open Label Treatment Period|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Visit 9. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Visit 10. Those on higher doses will be reduced between Visit 9 and 10 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at visit 10; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at visit 10). Dose increases beyond visit 10 are permitted and at the investigator's discretion.
10889228|NCT00510198|BG000|Baseline|Access Arm|Standard of Care and Cardiac Compass with OptiVol
10889229|NCT00510198|BG001|Baseline|Control Arm|Standard of Care alone
10889230|NCT00510198|BG002|Baseline|Total|Total of all reporting groups
10889231|NCT00510198|FG000|Participant Flow|Access Arm|Standard of Care and Cardiac Compass with OptiVol
10889232|NCT00510198|FG001|Participant Flow|Control Arm|Standard of Care alone
10889233|NCT00510198|OG000|Outcome|Access Arm|Standard of Care and Cardiac Compass with OptiVol
10889234|NCT00510198|OG001|Outcome|Control Arm|Standard of Care alone
10889235|NCT00510198|OG000|Outcome|Access Arm: Standard of Care and Cardiac Compass With OptiVol|"Standard of Care and Cardiac Compass with OptiVol~Cardiac Compass with OptiVol Fluid Status Monitoring: Review of Cardiac Compass with OptiVol Fluid Status Monitoring"
10889236|NCT00510198|OG001|Outcome|Control Arm: Standard of Care Alone|"Standard of Care alone~Standard of Care alone (clinical assessment): Clinical assessment utilizing standard of care, alone."
10889237|NCT00510198|EG000|Reported Event|Access Arm|Standard of Care and Cardiac Compass with OptiVol
10889238|NCT00510198|EG001|Reported Event|Control Arm|Standard of Care alone
10889239|NCT00510224|BG000|Baseline|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
10889240|NCT00510224|FG000|Participant Flow|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
10889241|NCT00510224|OG000|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
10889242|NCT00510224|EG000|Reported Event|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
10889243|NCT00510276|BG000|Baseline|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
10889244|NCT00510276|BG001|Baseline|Placebo|twice a day for 12 weeks
10889245|NCT00510276|BG002|Baseline|Total|Total of all reporting groups
10889246|NCT00510276|FG000|Participant Flow|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
10889247|NCT00510276|FG001|Participant Flow|Placebo|twice a day for 12 weeks
10889248|NCT00510276|OG000|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
10889249|NCT00510276|OG001|Outcome|Placebo|twice a day for 12 weeks
10889250|NCT00510276|OG000|Outcome|Atomoxetine 20 - 50 mg BID and Placebo|
10889251|NCT00510276|OG000|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
10889252|NCT00510276|OG001|Outcome|Atomoxetine 20 - 50 mg BID, Non-smokers|
10889253|NCT00510276|OG002|Outcome|Placebo, Smokers|
10889254|NCT00510276|OG003|Outcome|Placebo Non-smokers|
10889255|NCT00510276|OG001|Outcome|Atomoxetine 20 - 50 mg BID, Non-Smokers|
10889256|NCT00510276|OG003|Outcome|Placebo, Non-Smokers|
10889257|NCT00510276|EG000|Reported Event|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
10889258|NCT00510276|EG001|Reported Event|Placebo|twice a day for 12 weeks
10889259|NCT00510289|BG000|Baseline|All Patients|All patients who signed consent
10889260|NCT00510289|FG000|Participant Flow|All Patients|All patients who signed consent
10889261|NCT00510289|OG000|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
10889262|NCT00510289|OG000|Outcome|Evaluable Patients|Patients who received at least one cycle of study drug and underwent bone marrow assessments
10889263|NCT00510289|EG000|Reported Event|All Patients|SAEs are listed for all patients who took at least one dose of study drug. Due to early study closure and patient withdrawals, Other AEs are listed for 9 patients only.
10889264|NCT00510458|BG000|Baseline|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
11170893|NCT01999231|FG003|Participant Flow|20μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes ."
11170894|NCT01999231|OG000|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
11170895|NCT01999231|OG001|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
11170896|NCT01999231|OG002|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
11170897|NCT01999231|OG003|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
11170898|NCT01999231|OG002|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
11170899|NCT01999231|OG003|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
11170900|NCT01999231|EG000|Reported Event|1μg/ml ESAT6-CFP10|"Medicine Number 6 participant 24 h after test skin test, is observed local skin reactions and found subcutaneous hemorrhage ( 2 x 2 mm),48 h the subcutaneous hemorrhage is remain and becomes shallow ,72 h the subcutaneous hemorrhage is the same size and becomes lower shallow ,96 h the skin reaction has faded .This mild local skin reactions may be relevant with acupuncture of skin test , had nothing to do with experimental drugs by the judgement of principal investigator .~Medicine Number 12 participant occurred two cases of adverse events the seventh days after skin test :respectively pregnancy and a small amount of pleural effusion on both sides .This volunteer test results of a pregnancy test paper were negative in screening period,pregnancy test result were positive the seventh days after the skin test."
10851153|NCT00305084|BG003|Baseline|Cohort 4: NGRhTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.8 μg/m^2as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
11170901|NCT01999231|EG001|Reported Event|5μg/ml ESAT6-CFP10|"Medicine Number 2 participant 15 min and 30 min after skin test is observed local skin reactions and all found that scattered red dot (32 x 25 mm )appeared .After 30min each time point local skin reactions were negative .~This mild local skin reactions may be relevant with alcohol allergy , had nothing to do with experimental drugs by the judgement of principal investigator ."
11170902|NCT01999231|EG002|Reported Event|10μg/ml ESAT6-CFP10|There is no adverse event.
11170903|NCT01999231|EG003|Reported Event|20μg/ml ESAT6-CFP10|There is no adverse event.
11170904|NCT01999322|BG000|Baseline|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
11170905|NCT01999322|BG001|Baseline|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
11170906|NCT01999322|BG002|Baseline|Total|Total of all reporting groups
10889265|NCT00510458|FG000|Participant Flow|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
10851154|NCT00305084|BG004|Baseline|Cohort 5: NGRhTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 1.6 μg/m^2as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851155|NCT00305084|BG005|Baseline|Total|Total of all reporting groups
10851156|NCT00305084|FG000|Participant Flow|Cohort 1: NGR-hTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 60 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851157|NCT00305084|FG001|Participant Flow|Cohort 2: NGR-hTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851158|NCT00305084|FG002|Participant Flow|Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.4 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851159|NCT00305084|FG003|Participant Flow|Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851160|NCT00305084|FG004|Participant Flow|Cohort 5: NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 1.6 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851161|NCT00305084|OG000|Outcome|Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2|NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
10851162|NCT00305084|OG001|Outcome|Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2|NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
10851163|NCT00305084|OG002|Outcome|Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2|NGR-hTNF: 0.4 μg/m^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
10851164|NCT00305084|OG003|Outcome|Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2|NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
10851165|NCT00305084|OG004|Outcome|Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2|NGR-hTNF: 1.6 μg/m^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
10851166|NCT00305084|OG000|Outcome|Cohort 1: NGR-hTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 60 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851167|NCT00305084|OG001|Outcome|Cohort 2: NGR-hTNF 0.2 μg/m^2 + Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851168|NCT00305084|OG002|Outcome|Cohort 3: NGR-hTNF 0.4 μg/m^2 + Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.4 μg/m^2 as 60- minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851169|NCT00305084|OG003|Outcome|Cohort 4: NGR-hTNF 0.8 μg/m^2 + Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851170|NCT00305084|OG004|Outcome|Cohort 5: NGR-hTNF 1.6 μg/m^2 + Doxorubicin 75 mg/m^2|"NGR-hTNF: 1.6 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851171|NCT00305084|OG001|Outcome|Cohort 2: NGR-hTNF 0.2 μg/m^2 + Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851172|NCT00305084|OG002|Outcome|Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.4 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851173|NCT00305084|OG003|Outcome|Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851174|NCT00305084|OG000|Outcome|Cohort 1: NGR-hTNF 0.2 μg/m^2 + Doxorubicin 60 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 60 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851175|NCT00305084|OG002|Outcome|Cohort 3: NGR-hTNF 0.4 μg/m^2 + Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.4 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851176|NCT00305084|OG001|Outcome|Cohort 2: NGR-hTNF 0.2 μg/m^2 + Doxorubicin 75mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851177|NCT00305084|OG002|Outcome|Cohort 3: NGR-hTNF 0.4 μg/m^2 + Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.2, 0.4, 0.8 and 1.6 μg//m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851178|NCT00305084|OG003|Outcome|Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75mg/m^2|"NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851179|NCT00305084|OG004|Outcome|Cohort 5: NGR-hTNF 1.6 μg/m^2 + Doxorubicin 75mg/m^2|"NGR-hTNF: 1.6 μg/m^2as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851180|NCT00305084|OG002|Outcome|Cohort 3: NGR-hTNF 0.4 μg/m^2 + Doxorubicin 75mg/m^2|"NGR-hTNF: 0.4 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851181|NCT00305084|OG003|Outcome|Cohort 4: NGR-hTNF 0.8 μg/m^2 + Doxorubicin 75mg/m^2|"NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg//m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851182|NCT00305084|OG004|Outcome|Cohort 5: NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75mg/m^2|"NGR-hTNF: 1.6 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851183|NCT00305084|OG001|Outcome|Cohort 2: NGR-hTNF 0.2μg/m^2 + Doxorubicin 75mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851184|NCT00305084|OG003|Outcome|Cohort 4: NGR-hTNF 0.8 μg/m^2 + Doxorubicin 75mg/m^2|"NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851185|NCT00305084|OG004|Outcome|Cohort 5: NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75mg/m^2|"NGR-hTNF: 1.6 μg//m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851186|NCT00305084|OG002|Outcome|Cohort 3: NGR-hTNF 0.4 μg/m^2 + Doxorubicin 75mg/m^2|"NGR-hTNF: 0.4 μg/m^2as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851187|NCT00305084|OG004|Outcome|Cohort 5: NGR-hTNF 1.6 μg/m^2 + Doxorubicin 75mg/m^2|"NGR-hTNF: 1.6 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851188|NCT00305084|OG000|Outcome|NGR-hTNF: 0.2, 0.4, 0.8 and 1.6 μg/m²as 60-minute Intravenous|"NGR-hTNF: 0.2, 0.4, 0.8 and 1.6 μg/m²as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851189|NCT00305084|OG000|Outcome|Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 60 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851190|NCT00305084|OG001|Outcome|Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851191|NCT00305084|OG002|Outcome|Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.4 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851192|NCT00305084|OG003|Outcome|Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851193|NCT00305084|OG004|Outcome|Cohort 5: NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 1.6 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851194|NCT00305084|EG000|Reported Event|Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 60 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851195|NCT00305084|EG001|Reported Event|Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.2 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851196|NCT00305084|EG002|Reported Event|Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.4 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851197|NCT00305084|EG003|Reported Event|Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2|"NGR-hTNF: 0.8 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851198|NCT00305084|EG004|Reported Event|Cohort 5: NGR-hTNF: 1.6 μg/m^2 + Doxorubicin 75 mg/m^2|"NGR-hTNF: 1.6 μg/m^2 as 60-minute intravenous infusion every 3 weeks~Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)"
10851199|NCT00305110|BG000|Baseline|2 mg IV Hydromorphone|"2 mg IV hydromorphone administered over 2-3 minutes~2 mg IV hydromorphone"
10851200|NCT00305110|FG000|Participant Flow|2 mg IV Hydromorphone|"2 mg IV hydromorphone administered over 2-3 minutes~2 mg IV hydromorphone"
10851201|NCT00305110|OG000|Outcome|2 mg IV Hydromorphone|"2 mg IV hydromorphone administered over 2-3 minutes~2 mg IV hydromorphone"
10851202|NCT00305110|EG000|Reported Event|2 mg IV Hydromorphone|"2 mg IV hydromorphone administered over 2-3 minutes~2 mg IV hydromorphone"
10851203|NCT00305162|BG000|Baseline|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
10851204|NCT00305162|BG001|Baseline|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
10851205|NCT00305162|BG002|Baseline|Total|Total of all reporting groups
10851206|NCT00305162|FG000|Participant Flow|Cangrelor Arm|cangrelor arm: placebo capsules at PCI start + cangrelor bolus(30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
10851207|NCT00305162|FG001|Participant Flow|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion followed by placebo capsules post infusion
10851208|NCT00305162|OG000|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
10851209|NCT00305162|OG001|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
10889266|NCT00510458|OG000|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
10889267|NCT00510458|EG000|Reported Event|Operative Site Events|LFIT™ Femoral Heads With X3® Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.
10889268|NCT00510458|EG001|Reported Event|Non-operative Site Events|LFIT™ Femoral Heads With X3® Insert. Non-operative site events are reported by participant.
10889269|NCT00510484|BG000|Baseline|Placebo/Pancrelipase|
10889270|NCT00510484|BG001|Baseline|Pancrelipase/Placebo|
10889271|NCT00510484|BG002|Baseline|Total|Total of all reporting groups
10889272|NCT00510484|FG000|Participant Flow|Placebo/Pancrelipase|
10889273|NCT00510484|FG001|Participant Flow|Pancrelipase/Placebo|
10889274|NCT00510484|OG000|Outcome|Pancrelipase|
10889275|NCT00510484|OG001|Outcome|Placebo|
10889276|NCT00510484|EG000|Reported Event|Pancrelipase|
10889277|NCT00510484|EG001|Reported Event|Placebo|
10889278|NCT00510497|BG000|Baseline|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
10889279|NCT00510497|FG000|Participant Flow|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
10889280|NCT00510497|OG000|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
10889281|NCT00510497|EG000|Reported Event|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine (does not include one enrolled participant who received no study treatment)~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
10889282|NCT00510510|BG000|Baseline|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
10889283|NCT00510510|BG001|Baseline|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889284|NCT00510510|BG002|Baseline|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889285|NCT00510510|BG003|Baseline|Total|Total of all reporting groups
10889286|NCT00510510|FG000|Participant Flow|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889287|NCT00510510|FG001|Participant Flow|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889288|NCT00510510|FG002|Participant Flow|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889289|NCT00510510|OG000|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
10889290|NCT00510510|OG001|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889291|NCT00510510|OG002|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889292|NCT00510510|EG000|Reported Event|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
10889293|NCT00510510|EG001|Reported Event|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889294|NCT00510510|EG002|Reported Event|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
10889295|NCT00510653|BG000|Baseline|Imatinib Mesylate|600 mg/day orally for 6 Weeks
10889296|NCT00510653|FG000|Participant Flow|Imatinib Mesylate|600 mg/day orally for 6 Weeks
10889297|NCT00510653|OG000|Outcome|Imatinib Mesylate|600 mg/day orally for 6 Weeks
10889298|NCT00510653|EG000|Reported Event|Imatinib Mesylate|600 mg/day orally for 6 Weeks
10889299|NCT00510692|BG000|Baseline|2g/Day EPA|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
10889300|NCT00510692|BG001|Baseline|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
10889301|NCT00510692|BG002|Baseline|Total|Total of all reporting groups
10889302|NCT00510692|FG000|Participant Flow|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
10889303|NCT00510692|FG001|Participant Flow|Placebo|Medium chain triglycerides 2 g per day for six months.
10889304|NCT00510692|OG000|Outcome|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
10889305|NCT00510692|OG001|Outcome|Placebo|Medium chain triglycerides 2g per day for six months
10889306|NCT00510692|OG000|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
10889307|NCT00510692|OG001|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
10889308|NCT00510692|EG000|Reported Event|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
10889309|NCT00510692|EG001|Reported Event|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
10889310|NCT00510718|BG000|Baseline|MDV3100 (Enzalutamide) 30 mg/Day|Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889311|NCT00510718|BG001|Baseline|MDV3100 (Enzalutamide) 60 mg /Day|Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889312|NCT00510718|BG002|Baseline|MDV3100 (Enzalutamide) 150/160 mg/Day|Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
10889313|NCT00510718|BG003|Baseline|MDV3100 (Enzalutamide) 240 mg /Day|Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889314|NCT00510718|BG004|Baseline|MDV3100 (Enzalutamide) 360 mg /Day|Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889315|NCT00510718|BG005|Baseline|MDV3100 (Enzalutamide) 480 mg /Day|Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889316|NCT00510718|BG006|Baseline|MDV3100 (Enzalutamide) 600 mg /Day|Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889317|NCT00510718|BG007|Baseline|Total|Total of all reporting groups
10889318|NCT00510718|FG000|Participant Flow|MDV3100 (Enzalutamide): No Previous Chemotherapy|Participants with no prior exposure to chemotherapy received single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 milligram per day (mg/day) dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the maximum tolerated dose (MTD) was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, dose limiting toxicity (DLT) or disease progression occurred. Participants were followed up for 30 days after last dose of study drug for safety follow up.
10889319|NCT00510718|FG001|Participant Flow|MDV3100 (Enzalutamide): Post Chemotherapy|Participants with prior exposure to chemotherapy single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 mg/day dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the MTD was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period, for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, DLT or disease progression occurred. Participants were followed up for 30 days after last dose.
10889320|NCT00510718|OG000|Outcome|MDV3100 (Enzalutamide) 30 mg/Day|Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889321|NCT00510718|OG001|Outcome|MDV3100 (Enzalutamide) 60 mg /Day|Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889322|NCT00510718|OG002|Outcome|MDV3100 (Enzalutamide) 150/160 mg/Day|Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
10889323|NCT00510718|OG003|Outcome|MDV3100 (Enzalutamide) 240 mg /Day|Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889324|NCT00510718|OG004|Outcome|MDV3100 (Enzalutamide) 360 mg /Day|Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889325|NCT00510718|OG005|Outcome|MDV3100 (Enzalutamide) 480 mg /Day|Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889326|NCT00510718|OG006|Outcome|MDV3100 (Enzalutamide) 600 mg /Day|Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889327|NCT00510718|OG007|Outcome|MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period|All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
10889328|NCT00510718|OG000|Outcome|MDV3100 (Enzalutamide) : All Participants|Participants received single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 mg/day dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the MTD was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period for 84 days.
10889329|NCT00510718|EG000|Reported Event|MDV3100 (Enzalutamide) 30 mg/Day|Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889330|NCT00510718|EG001|Reported Event|MDV3100 (Enzalutamide) 60 mg /Day|Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889331|NCT00510718|EG002|Reported Event|MDV3100 (Enzalutamide) 150/160 mg/Day|Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
10889332|NCT00510718|EG003|Reported Event|MDV3100 (Enzalutamide) 240 mg /Day|Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889333|NCT00510718|EG004|Reported Event|MDV3100 (Enzalutamide) 360 mg /Day|Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889334|NCT00510718|EG005|Reported Event|MDV3100 (Enzalutamide) 480 mg /Day|Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889335|NCT00510718|EG006|Reported Event|MDV3100 (Enzalutamide) 600 mg /Day|Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
10889336|NCT00510718|EG007|Reported Event|MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period|All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
10889337|NCT00510744|BG000|Baseline|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
10889338|NCT00510744|FG000|Participant Flow|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
10889339|NCT00510744|OG000|Outcome|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~The ability of pancreatic enzyme supplement: 4 caps with meals, 2 with snacks to improve fat absorption"
10889340|NCT00510744|EG000|Reported Event|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
10889341|NCT00510783|BG000|Baseline|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
10889342|NCT00510783|BG001|Baseline|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
10889343|NCT00510783|BG002|Baseline|Total|Total of all reporting groups
10889344|NCT00510783|FG000|Participant Flow|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
10889345|NCT00510783|FG001|Participant Flow|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
10889346|NCT00510783|OG000|Outcome|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
10889347|NCT00510783|OG001|Outcome|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
10889348|NCT00510783|EG000|Reported Event|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
10889349|NCT00510783|EG001|Reported Event|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
10851210|NCT00305162|OG001|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
10851211|NCT00305162|EG000|Reported Event|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
10851212|NCT00305162|EG001|Reported Event|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
11170907|NCT01999322|FG000|Participant Flow|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
11170908|NCT01999322|FG001|Participant Flow|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
10851213|NCT00305227|BG000|Baseline|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
10851214|NCT00305227|BG001|Baseline|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
11335584|NCT03553758|BG000|Baseline|Ketamine|"15 subjects undergoing ketamine general anesthesia.~Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."
10851215|NCT00305227|BG002|Baseline|Total|Total of all reporting groups
10889350|NCT00510809|BG000|Baseline|Statin and Policosanol|20mg daily, double-blind
10889351|NCT00510809|BG001|Baseline|Statin and Placebo|20mg daily, double-blind
10889352|NCT00510809|BG002|Baseline|Policosanol|20 mg daily, open label
10889353|NCT00510809|BG003|Baseline|Total|Total of all reporting groups
10889354|NCT00510809|FG000|Participant Flow|Statin and Policosanol|20mg daily, double-blind
10889355|NCT00510809|FG001|Participant Flow|Statin and Placebo|20mg daily, double-blind
10889356|NCT00510809|FG002|Participant Flow|Policosanol|20 mg daily, open label
10889357|NCT00510809|OG000|Outcome|Statin and Policosanol|20mg daily, double-blind
10889358|NCT00510809|OG001|Outcome|Statin and Placebo|20mg daily, double-blind
10889359|NCT00510809|OG002|Outcome|Policosanol|20 mg daily, open label
10889360|NCT00510809|EG000|Reported Event|Statin and Policosanol|20mg daily, double-blind
10889361|NCT00510809|EG001|Reported Event|Statin and Placebo|20mg daily, double-blind
10889362|NCT00510809|EG002|Reported Event|Policosanol|20 mg daily, open label
10889363|NCT00510835|BG000|Baseline|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
10889364|NCT00510835|BG001|Baseline|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
10889365|NCT00510835|BG002|Baseline|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
10889366|NCT00510835|BG003|Baseline|Total|Total of all reporting groups
10889367|NCT00510835|FG000|Participant Flow|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
10889368|NCT00510835|FG001|Participant Flow|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
10889369|NCT00510835|FG002|Participant Flow|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
10889370|NCT00510835|OG000|Outcome|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
10889371|NCT00510835|OG001|Outcome|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
10889372|NCT00510835|OG002|Outcome|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
11335585|NCT03553758|FG000|Participant Flow|Ketamine|"15 subjects undergoing ketamine general anesthesia.~Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."
10851216|NCT00305227|FG000|Participant Flow|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
10851217|NCT00305227|FG001|Participant Flow|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
10889373|NCT00510835|EG000|Reported Event|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
10889374|NCT00510835|EG001|Reported Event|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
10889375|NCT00510835|EG002|Reported Event|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
10889376|NCT00510874|BG000|Baseline|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889377|NCT00510874|BG001|Baseline|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889378|NCT00510874|BG002|Baseline|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889379|NCT00510874|BG003|Baseline|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889380|NCT00510874|BG004|Baseline|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889381|NCT00510874|BG005|Baseline|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889382|NCT00510874|BG006|Baseline|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889383|NCT00510874|BG007|Baseline|Total|Total of all reporting groups
10889384|NCT00510874|FG000|Participant Flow|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889385|NCT00510874|FG001|Participant Flow|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889386|NCT00510874|FG002|Participant Flow|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889387|NCT00510874|FG003|Participant Flow|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889388|NCT00510874|FG004|Participant Flow|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889389|NCT00510874|FG005|Participant Flow|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
11335586|NCT03553758|OG000|Outcome|Ketamine EEG Dynamics|"15 subjects undergoing ketamine general anesthesia.~Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."
10889390|NCT00510874|FG006|Participant Flow|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889391|NCT00510874|OG000|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889392|NCT00510874|OG001|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889393|NCT00510874|OG002|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889394|NCT00510874|OG003|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889395|NCT00510874|OG004|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889396|NCT00510874|OG005|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889397|NCT00510874|OG006|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889398|NCT00510874|OG000|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889399|NCT00510874|EG000|Reported Event|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889400|NCT00510874|EG001|Reported Event|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889401|NCT00510874|EG002|Reported Event|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889402|NCT00510874|EG003|Reported Event|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
11174200|NCT02020252|OG000|Outcome|Touchscreen Participants|"New lung, gastric and pancreatic cancer patients presenting to the University of Chicago outpatient oncology clinics, a large research institution located on Chicago's Southside, were identified for study accrual, using the electronic scheduling system.~Testing an interactive technology in a diverse health literary population: Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. We tested an interactive technology designed for patients with diverse health literacy skills aimed at improving patient receptiveness, willingness, knowledge, self-efficacy and positive attitudes regarding clinical trials."
10889403|NCT00510874|EG004|Reported Event|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889404|NCT00510874|EG005|Reported Event|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889405|NCT00510874|EG006|Reported Event|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
10889406|NCT00510887|BG000|Baseline|VR-FND|"Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
10889407|NCT00510887|FG000|Participant Flow|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
10889408|NCT00510887|OG000|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
10889409|NCT00510887|EG000|Reported Event|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
10889410|NCT00510952|BG000|Baseline|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
10889411|NCT00510952|BG001|Baseline|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
10889412|NCT00510952|BG002|Baseline|Total|Total of all reporting groups
10889413|NCT00510952|FG000|Participant Flow|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
10889414|NCT00510952|FG001|Participant Flow|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
10889415|NCT00510952|OG000|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
10889416|NCT00510952|OG001|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
10889417|NCT00510952|EG000|Reported Event|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
10889418|NCT00510952|EG001|Reported Event|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
10889419|NCT00511004|BG000|Baseline|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
11170909|NCT01999322|OG000|Outcome|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
10889420|NCT00511004|BG001|Baseline|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
10889421|NCT00511004|BG002|Baseline|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
10889422|NCT00511004|BG003|Baseline|Total|Total of all reporting groups
10889423|NCT00511004|FG000|Participant Flow|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
10889424|NCT00511004|FG001|Participant Flow|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
10889425|NCT00511004|FG002|Participant Flow|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
10889426|NCT00511004|OG000|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
10889427|NCT00511004|OG001|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
10889428|NCT00511004|OG002|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
10889429|NCT00511004|OG000|Outcome|Diethylcarbamazine/Albendazole -STD|"Standard therapy of diethylcarbamazine (DEC) (300mg) and albendazole (400mg) yearly~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
10889430|NCT00511004|OG001|Outcome|Diethylcarbamazine/Albendazole- HD1|"High dose of DEC (300mg) and albendazole (800mg) yearly~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
10889431|NCT00511004|OG002|Outcome|Diethylcarbamazine/Albendazole-HD2|"High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
10889432|NCT00511004|EG000|Reported Event|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
10889433|NCT00511004|EG001|Reported Event|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
10889434|NCT00511004|EG002|Reported Event|High Dose Semiannual DEC/AC=LB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
10889435|NCT00511095|BG000|Baseline|HEPLISAV|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4
10889436|NCT00511095|FG000|Participant Flow|HEPLISAV|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4
10889437|NCT00511095|OG000|Outcome|HEPLISAV (Week 0)|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0
10889438|NCT00511095|OG001|Outcome|HEPLISAV (Week 4)|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 4
10889439|NCT00511095|OG000|Outcome|HEPLISAV (Week 4)|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 4
10889440|NCT00511095|OG001|Outcome|HEPLISAV (Week 8)|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 8
10889441|NCT00511095|OG002|Outcome|HEPLISAV (Week 12)|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 12
10889442|NCT00511095|OG003|Outcome|HEPLISAV (Week 28)|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 28
10889443|NCT00511095|OG000|Outcome|HEPLISAV|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4
10889444|NCT00511095|EG000|Reported Event|HEPLISAV|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4
10889445|NCT00511108|BG000|Baseline|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
10889446|NCT00511108|BG001|Baseline|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
10889447|NCT00511108|BG002|Baseline|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
10889448|NCT00511108|BG003|Baseline|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
10889449|NCT00511108|BG004|Baseline|Total|Total of all reporting groups
10889450|NCT00511108|FG000|Participant Flow|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
10889451|NCT00511108|FG001|Participant Flow|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
10889452|NCT00511108|FG002|Participant Flow|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
10889453|NCT00511108|FG003|Participant Flow|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
10889454|NCT00511108|OG000|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
10889455|NCT00511108|OG001|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
10889456|NCT00511108|OG002|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
10889457|NCT00511108|OG003|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
10889458|NCT00511108|EG000|Reported Event|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
10889459|NCT00511108|EG001|Reported Event|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
10889460|NCT00511108|EG002|Reported Event|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
10889461|NCT00511108|EG003|Reported Event|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
10889462|NCT00511147|BG000|Baseline|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
10889463|NCT00511147|FG000|Participant Flow|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
10889464|NCT00511147|OG000|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
10889465|NCT00511147|EG000|Reported Event|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
10889466|NCT00511173|BG000|Baseline|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
10889467|NCT00511173|FG000|Participant Flow|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
10889468|NCT00511173|OG000|Outcome|Algorithm Dosing|Warfarin dose based on algorithm by Sconce, et al.
10889469|NCT00511173|OG001|Outcome|Pharmacist Dosing|Warfarin dose based on clinician dosing
10889470|NCT00511173|EG000|Reported Event|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
10889471|NCT00511238|BG000|Baseline|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle
10889472|NCT00511238|BG001|Baseline|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
10889473|NCT00511238|BG002|Baseline|Total|Total of all reporting groups
10889474|NCT00511238|FG000|Participant Flow|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles
10851218|NCT00305227|OG000|Outcome|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
10851219|NCT00305227|OG001|Outcome|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
10851220|NCT00305227|EG000|Reported Event|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
10851221|NCT00305227|EG001|Reported Event|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
10851222|NCT00305253|BG000|Baseline|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
10851223|NCT00305253|BG001|Baseline|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
10851224|NCT00305253|BG002|Baseline|Total|Total of all reporting groups
10851225|NCT00305253|FG000|Participant Flow|Pre-Intervention|Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol.
10851226|NCT00305253|FG001|Participant Flow|Post-Intervention|Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG.
10851227|NCT00305253|OG000|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
10851228|NCT00305253|OG001|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
10851229|NCT00305253|EG000|Reported Event|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
10851230|NCT00305253|EG001|Reported Event|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
10851231|NCT00305448|BG000|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
10851232|NCT00305448|BG001|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
10851233|NCT00305448|BG002|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
10851234|NCT00305448|BG003|Baseline|Total|Total of all reporting groups
10851235|NCT00305448|FG000|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
10851236|NCT00305448|FG001|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
10851237|NCT00305448|FG002|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
10851238|NCT00305448|OG000|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
10851239|NCT00305448|OG001|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
10851240|NCT00305448|OG002|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
10851241|NCT00305448|OG000|Outcome|Fulvestrant|Fulvestrant
10851242|NCT00305448|EG000|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
10851243|NCT00305448|EG001|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
10851244|NCT00305448|EG002|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
10851245|NCT00305565|BG000|Baseline|Low Dose|Received output current 0.25 mA
10851246|NCT00305565|BG001|Baseline|Medium Dose|Received output current 0.5-1.0 mA
10851247|NCT00305565|BG002|Baseline|High Dose|Received output current 1.0-1.5 mA
10851248|NCT00305565|BG003|Baseline|Total|Total of all reporting groups
10851249|NCT00305565|FG000|Participant Flow|Low Dose|Received output current 0.25 milliamps (mA)
10851250|NCT00305565|FG001|Participant Flow|Medium Dose|Received output current 0.5-1.0 mA
10851251|NCT00305565|FG002|Participant Flow|High Dose|Received output current 1.0-1.5 mA
10851252|NCT00305565|OG000|Outcome|Low Dose|Received output current 0.25 mA
10851253|NCT00305565|OG001|Outcome|Medium Dose|Received output current 0.5-1.0 mA
10851254|NCT00305565|OG002|Outcome|High Dose|Received output current 1.0-1.5 mA
10851255|NCT00305565|OG000|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
10851256|NCT00305565|EG000|Reported Event|Low Dose|Received output current 0.25 mA
10851257|NCT00305565|EG001|Reported Event|Medium Dose|Received output current 0.5-1.0 mA
10851258|NCT00305565|EG002|Reported Event|High Dose|Received output current 1.0-1.5 mA
10851259|NCT00305578|BG000|Baseline|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
10851260|NCT00305578|BG001|Baseline|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
10851261|NCT00305578|BG002|Baseline|Total|Total of all reporting groups
10851262|NCT00305578|FG000|Participant Flow|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
10851263|NCT00305578|FG001|Participant Flow|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
10851264|NCT00305578|OG000|Outcome|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
10851265|NCT00305578|OG001|Outcome|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
10851266|NCT00305578|EG000|Reported Event|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
10889475|NCT00511238|FG001|Participant Flow|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
10851267|NCT00305578|EG001|Reported Event|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
10851268|NCT00305604|BG000|Baseline|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
10851269|NCT00305604|BG001|Baseline|Placebo|Sitagliptin-matching placebo tablets.
10851270|NCT00305604|BG002|Baseline|Total|Total of all reporting groups
10851271|NCT00305604|FG000|Participant Flow|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
10851272|NCT00305604|FG001|Participant Flow|Placebo|Sitagliptin-matching placebo tablets.
10851273|NCT00305604|OG000|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
10851274|NCT00305604|OG001|Outcome|Placebo|Sitagliptin-matching placebo tablets.
10851275|NCT00305604|EG000|Reported Event|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
10851276|NCT00305604|EG001|Reported Event|Placebo|Sitagliptin-matching placebo tablets.
10851277|NCT00305682|BG000|Baseline|Arm 1-Previous Autologous Transplant|hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851278|NCT00305682|BG001|Baseline|Arm 2 - No Prior Autologous Transplant|Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851279|NCT00305682|BG002|Baseline|Arm 3 - Refractory Leukemia/Lymphoma|Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851280|NCT00305682|BG003|Baseline|Arm 4: MT2006-01 Coenrolling Patients|Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851281|NCT00305682|BG004|Baseline|Arm 5 - Previous Autologous Transplant|Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851282|NCT00305682|BG005|Baseline|Arm 6 - No Prior Autologous Transplant|Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851283|NCT00305682|BG006|Baseline|Total|Total of all reporting groups
10851284|NCT00305682|FG000|Participant Flow|Arm 1-Previous Autologous Transplant|hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851285|NCT00305682|FG001|Participant Flow|Arm 2 - No Prior Autologous Transplant|Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851286|NCT00305682|FG002|Participant Flow|Arm 3 - Refractory Leukemia/Lymphoma|Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851287|NCT00305682|FG003|Participant Flow|Arm 4: MT2006-01 Coenrolling Patients|Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10889476|NCT00511238|OG000|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle~Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib."
10889477|NCT00511238|OG001|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"
10889478|NCT00511238|OG000|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle.~Assessed by principal investigator."
10889479|NCT00511238|OG000|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Assessed by Independent Review Committee"
10889480|NCT00511238|OG000|Outcome|Carfilzomib (A0) for (ORR)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
10889481|NCT00511238|OG000|Outcome|Carfilzomib (A1) for (ORR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with ORR.
10889482|NCT00511238|OG001|Outcome|Carfilzomib (A1) for (CBR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with CBR.
10889483|NCT00511238|OG000|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle.~Assesed by principal investigator."
10889484|NCT00511238|OG000|Outcome|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
10889485|NCT00511238|OG000|Outcome|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
10889486|NCT00511238|OG000|Outcome|Carfilzomib (A1) - Safety Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Safety population: The safety population was used for the analysis of safety data in this study. The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib. However, for some safety analyses, at least 1 laboratory, neurological, electrocardiogram, or vital sign measurement obtained subsequent to at least 1 dose of carfilzomib was required for inclusion in the analysis of a safety specific parameter. To assess change from baseline, a baseline measurement was also required."
10889487|NCT00511238|OG001|Outcome|Carfilzomib (A1) - Response-evaluable Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Response-Evaluable Population(the primary analysis population) was defined as all patients who~had measurable disease at Baseline by either M-protein (serum and/or urine) or by quantitative serum Ig for certain patients with IgA myeloma~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or patients who discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib-irrespective of availability of baseline and post-baseline assessment"
10889488|NCT00511238|EG000|Reported Event|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
10889489|NCT00511238|EG001|Reported Event|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
10889490|NCT00511472|BG000|Baseline|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
10889491|NCT00511472|BG001|Baseline|Placebo|Participants receiving placebo while on basal insulin.
10889492|NCT00511472|BG002|Baseline|Total|Total of all reporting groups
10889493|NCT00511472|FG000|Participant Flow|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
10889494|NCT00511472|FG001|Participant Flow|Placebo|Participants receiving placebo while on basal insulin.
10889495|NCT00511472|OG000|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
10889496|NCT00511472|OG001|Outcome|Placebo|Participants receiving placebo while on basal insulin.
10889497|NCT00511472|OG000|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
10889498|NCT00511472|OG000|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
10889499|NCT00511472|OG000|Outcome|MK-0941 (Titration Group 1)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
10889500|NCT00511472|OG001|Outcome|MK-0941 (Titration Group 2)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
10889501|NCT00511472|OG002|Outcome|Placebo|Participants receiving placebo while on basal insulin.
10889502|NCT00511472|OG000|Outcome|MK-0941|Participants receiving individualized doses of MK-0941 while on basal insulin
10889503|NCT00511472|OG001|Outcome|Placebo|Participants receiving placebo while on basal insulin
10889504|NCT00511472|EG000|Reported Event|MK-0941 Titration 1|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 1 while on basal insulin.
10889505|NCT00511472|EG001|Reported Event|MK-0941 Titration 2|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 2 while on basal insulin.
10889506|NCT00511472|EG002|Reported Event|Placebo Titration 1|Participants receiving placebo while on basal insulin.
10889507|NCT00511472|EG003|Reported Event|Placebo Titration 2|Participants receiving placebo while on basal insulin.
10889508|NCT00511667|BG000|Baseline|MK-0941|All participants receiving any dose of MK-0941
10889509|NCT00511667|BG001|Baseline|Placebo|All participants receiving any dose of placebo
10889510|NCT00511667|BG002|Baseline|Total|Total of all reporting groups
10889511|NCT00511667|FG000|Participant Flow|MK-0941|All participants receiving any dose of MK-0941
10889512|NCT00511667|FG001|Participant Flow|Placebo|All participants receiving any dose of placebo
10889513|NCT00511667|OG000|Outcome|MK-0941|All participants receiving any dose of MK-0941
10889514|NCT00511667|OG001|Outcome|Placebo|All participants receiving any dose of placebo
10889515|NCT00511667|OG000|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
10889516|NCT00511667|OG001|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
10889517|NCT00511667|OG002|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
10889518|NCT00511667|OG003|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
10889519|NCT00511667|OG004|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
10889520|NCT00511667|OG000|Outcome|Panel A: MK-0941 10 mg Before Each Meal|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
10889521|NCT00511667|EG000|Reported Event|MK-0941|All participants receiving any dose of MK-0941
10889522|NCT00511667|EG001|Reported Event|Placebo|All participants receiving any dose of placebo
10889523|NCT00511706|BG000|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
10889524|NCT00511706|BG001|Baseline|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
10889525|NCT00511706|BG002|Baseline|Total|Total of all reporting groups
10889526|NCT00511706|FG000|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
10889527|NCT00511706|FG001|Participant Flow|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
10889528|NCT00511706|OG000|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
10889529|NCT00511706|OG001|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
10889530|NCT00511706|EG000|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
10889531|NCT00511706|EG001|Reported Event|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
10889532|NCT00511797|BG000|Baseline|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889533|NCT00511797|BG001|Baseline|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889534|NCT00511797|BG002|Baseline|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889535|NCT00511797|BG003|Baseline|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
10889536|NCT00511797|BG004|Baseline|Total|Total of all reporting groups
10889537|NCT00511797|FG000|Participant Flow|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889538|NCT00511797|FG001|Participant Flow|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889539|NCT00511797|FG002|Participant Flow|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889540|NCT00511797|FG003|Participant Flow|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
10889541|NCT00511797|OG000|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889542|NCT00511797|OG001|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889543|NCT00511797|OG002|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889544|NCT00511797|OG003|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
10889545|NCT00511797|EG000|Reported Event|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889546|NCT00511797|EG001|Reported Event|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
11170910|NCT01999322|OG001|Outcome|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
11170911|NCT01999322|EG000|Reported Event|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
11170912|NCT01999322|EG001|Reported Event|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
11170913|NCT01999335|BG000|Baseline|Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170914|NCT01999335|BG001|Baseline|Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170915|NCT01999335|BG002|Baseline|Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170916|NCT01999335|BG003|Baseline|Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170917|NCT01999335|BG004|Baseline|Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170918|NCT01999335|BG005|Baseline|Total|Total of all reporting groups
11170919|NCT01999335|FG000|Participant Flow|Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170920|NCT01999335|FG001|Participant Flow|Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170921|NCT01999335|FG002|Participant Flow|Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170922|NCT01999335|FG003|Participant Flow|Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170923|NCT01999335|FG004|Participant Flow|Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170924|NCT01999335|OG000|Outcome|Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170925|NCT01999335|OG001|Outcome|Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
10889547|NCT00511797|EG002|Reported Event|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
10889548|NCT00511797|EG003|Reported Event|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
10889549|NCT00511810|BG000|Baseline|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
10889550|NCT00511810|BG001|Baseline|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
10889551|NCT00511810|BG002|Baseline|Total|Total of all reporting groups
10889552|NCT00511810|FG000|Participant Flow|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
10889553|NCT00511810|FG001|Participant Flow|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
10889554|NCT00511810|OG000|Outcome|Baseline CDRS-R: High Dose Fish Oil|CDRS-R scores were computed for High Fish Oil groups.
10889555|NCT00511810|OG001|Outcome|Baseline CDRS-R: Low Dose Fish Oil|CDRS-R scores were computed for Low Fish Oil groups.
10889556|NCT00511810|EG000|Reported Event|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
10889557|NCT00511810|EG001|Reported Event|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
10889558|NCT00511836|BG000|Baseline|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
10889559|NCT00511836|BG001|Baseline|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
10889560|NCT00511836|BG002|Baseline|Total|Total of all reporting groups
10889561|NCT00511836|FG000|Participant Flow|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
10889562|NCT00511836|FG001|Participant Flow|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
10889563|NCT00511836|OG000|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
10889564|NCT00511836|OG001|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
10889565|NCT00511836|EG000|Reported Event|VIVITROL 380 mg (Double-blind Period)|VIVITROL 380 mg (naltrexone for extended-release injectable suspension). Data are described for the initial 28-day double-blind period.
10889566|NCT00511836|EG001|Reported Event|Placebo (Double-blind Period)|Placebo for VIVITROL 380 mg. Data are described for the initial 28-day double-blind period.
10889567|NCT00511836|EG002|Reported Event|Optional Open-label VIVITROL Period (2 Months)|Following the 28-day, double-blind treatment period, all subjects were offered a chance to receive open-label VIVITROL for an additional 2 months (2 injections, each separated by 1 month). Safety data are described for all subjects in the VIVITROL open-label period, regardless of the treatment received (VIVITROL or placebo) for the first month.
10889568|NCT00511862|BG000|Baseline|Colorectal Cancer|colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy
10889569|NCT00511862|BG001|Baseline|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
10889570|NCT00511862|BG002|Baseline|Non-Colorectal/Non-neuroendocrine|patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy
10889571|NCT00511862|BG003|Baseline|Total|Total of all reporting groups
10889572|NCT00511862|FG000|Participant Flow|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
10889573|NCT00511862|FG001|Participant Flow|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
10889574|NCT00511862|FG002|Participant Flow|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
10889575|NCT00511862|OG000|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
10889576|NCT00511862|OG001|Outcome|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
10889577|NCT00511862|OG002|Outcome|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
10889578|NCT00511862|OG003|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
10889579|NCT00511862|OG001|Outcome|Non Colorectal/Non-Neuroendocrine|Patients with metastatic liver disease arising from primary cancers other than colorectal or neuroendocrine cancer who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
10889580|NCT00511862|OG002|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
10889581|NCT00511862|OG000|Outcome|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
10889582|NCT00511862|EG000|Reported Event|TheraSphere|total population receiving at least one TheraSphere treatment
10889583|NCT00511875|BG000|Baseline|Placebo|"stratified equally to placebo taken once daily for 24 months~placebo: placebo taken once daily for 24 months"
10889584|NCT00511875|BG001|Baseline|Doxycycline Monohydrate|"stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months~doxycycline monohydrate: 50mg once daily for 24 months"
10889585|NCT00511875|BG002|Baseline|Total|Total of all reporting groups
10889586|NCT00511875|FG000|Participant Flow|Doxycycline Monohydrate|"stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months~doxycycline monohydrate: 50mg once daily for 24 months"
10889587|NCT00511875|FG001|Participant Flow|Placebo|"stratified equally to placebo taken once daily for 24 months~placebo: placebo taken once daily for 24 months"
10889588|NCT00511875|OG000|Outcome|Placebo|"stratified equally to placebo taken once daily for 24 months~placebo: placebo taken once daily for 24 months"
11170926|NCT01999335|OG002|Outcome|Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
10889589|NCT00511875|OG001|Outcome|Doxycycline Monohydrate|"stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months~doxycycline monohydrate: 50mg once daily for 24 months"
10889590|NCT00511875|EG000|Reported Event|Placebo|"stratified equally to placebo taken once daily for 24 months~placebo: placebo taken once daily for 24 months"
10889591|NCT00511875|EG001|Reported Event|Doxycycline Monohydrate|"stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months~doxycycline monohydrate: 50mg once daily for 24 months"
10889592|NCT00511901|BG000|Baseline|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
10889593|NCT00511901|BG001|Baseline|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
10889594|NCT00511901|BG002|Baseline|Total|Total of all reporting groups
10889595|NCT00511901|FG000|Participant Flow|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
10889596|NCT00511901|FG001|Participant Flow|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
10889597|NCT00511901|OG000|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
10889598|NCT00511901|OG001|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
10889599|NCT00511901|EG000|Reported Event|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
10889600|NCT00511901|EG001|Reported Event|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
10889601|NCT00511914|BG000|Baseline|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
10889602|NCT00511914|BG001|Baseline|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
10889603|NCT00511914|BG002|Baseline|Total|Total of all reporting groups
10889604|NCT00511914|FG000|Participant Flow|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
10889605|NCT00511914|FG001|Participant Flow|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
10889606|NCT00511914|OG000|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
10889607|NCT00511914|OG001|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
10889608|NCT00511914|EG000|Reported Event|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
10889609|NCT00511914|EG001|Reported Event|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
10889610|NCT00511992|BG000|Baseline|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
10889611|NCT00511992|FG000|Participant Flow|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
10889612|NCT00511992|OG000|Outcome|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
10889613|NCT00511992|EG000|Reported Event|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
10889614|NCT00512096|BG000|Baseline|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
10889615|NCT00512096|FG000|Participant Flow|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
10889616|NCT00512096|OG000|Outcome|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
10889617|NCT00512096|EG000|Reported Event|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
10889618|NCT00512135|BG000|Baseline|IncobotulinumtoxinA 20 U|Participants, pre-treated with placebo, and incobotulinumtoxinA (NT 201) 10, 20 and 30 U in feeder studies; received incobotulinumtoxinA 20 U powder for solution for injection, intramuscularly, in equal aliquots to 5 injection sites (Point A [one injection in procerus muscle at crossing of two lines that connect Point B and contralateral caruncle], Point B [one injection on each side in central part of corrugator muscle approximately 1 cm) above bony orbital rim on an imaginary line drawn vertically from caruncle], and Point C [one injection on each side in middle part of corrugator muscle at least 1.5 cm above bony orbital rim on an imaginary line drawn vertically from midpupillary line]) on Day 0 of Cycle 1. Re-injections based on investigator assessment were performed on Day 0 of subsequent cycles (up to 8 cycles for participants enrolled from MRZ 60201-0520/1 and MRZ 60201-0527/1; and up to 2 cycles for participants enrolled from MRZ 60201-0724/1 and MRZ 60201-0741/1). Each cycle length >=85 days.
10889619|NCT00512135|FG000|Participant Flow|IncobotulinumtoxinA 20 U|Participants, pre-treated with placebo, and incobotulinumtoxinA (NT 201) 10, 20 and 30 units (U) in feeder studies; received incobotulinumtoxinA 20 U powder for solution for injection, intramuscularly, in equal aliquots to 5 injection sites (Point A [one injection in procerus muscle at crossing of two lines that connect Point B and contralateral caruncle], Point B [one injection on each side in central part of corrugator muscle approximately 1 centimeter (cm) above bony orbital rim on an imaginary line drawn vertically from caruncle], and Point C [one injection on each side in middle part of corrugator muscle at least 1.5 cm above bony orbital rim on an imaginary line drawn vertically from midpupillary line]) on Day 0 of Cycle 1. Re-injections based on investigator assessment were performed on Day 0 of subsequent cycles (up to 8 cycles for participants enrolled from MRZ 60201-0520/1 and MRZ 60201-0527/1; and up to 2 cycles for participants enrolled from MRZ 60201-0724/1 and MRZ 60201-0741/1). Each cycle length greater than or equal to (>=) 85 days.
10889620|NCT00512135|OG000|Outcome|IncobotulinumtoxinA 20 U|Participants, pre-treated with placebo, and incobotulinumtoxinA (NT 201) 10, 20 and 30 U in feeder studies; received incobotulinumtoxinA 20 U powder for solution for injection, intramuscularly, in equal aliquots to 5 injection sites (Point A [one injection in procerus muscle at crossing of two lines that connect Point B and contralateral caruncle], Point B [one injection on each side in central part of corrugator muscle approximately 1 cm above bony orbital rim on an imaginary line drawn vertically from caruncle], and Point C [one injection on each side in middle part of corrugator muscle at least 1.5 cm above bony orbital rim on an imaginary line drawn vertically from midpupillary line]) on Day 0 of Cycle 1. Re-injections based on investigator assessment were performed on Day 0 of subsequent cycles (up to 8 cycles for participants enrolled from MRZ 60201-0520/1 and MRZ 60201-0527/1; and up to 2 cycles for participants enrolled from MRZ 60201-0724/1 and MRZ 60201-0741/1). Each cycle length >=85 days.
10889621|NCT00512135|OG000|Outcome|IncobotulinumtoxinA 20 U|Participants, pre-treated with placebo, and incobotulinumtoxinA (NT 201) 10, 20 and 30 U in feeder studies; received incobotulinumtoxinA 20 U powder for solution for injection, intramuscularly, in equal aliquots to 5 injection sites (Point A [one injection in procerus muscle at crossing of two lines that connect Point B and contralateral caruncle], Point B [one injection on each side in central part of corrugator muscle approximately 1 cm) above bony orbital rim on an imaginary line drawn vertically from caruncle], and Point C [one injection on each side in middle part of corrugator muscle at least 1.5 cm above bony orbital rim on an imaginary line drawn vertically from midpupillary line]) on Day 0 of Cycle 1. Re-injections based on investigator assessment were performed on Day 0 of subsequent cycles (up to 8 cycles for participants enrolled from MRZ 60201-0520/1 and MRZ 60201-0527/1; and up to 2 cycles for participants enrolled from MRZ 60201-0724/1 and MRZ 60201-0741/1). Each cycle length >=85 days.
10889622|NCT00512135|EG000|Reported Event|IncobotulinumtoxinA 20 U|Participants, pre-treated with placebo, and incobotulinumtoxinA (NT 201) 10, 20 and 30 U in feeder studies; received incobotulinumtoxinA 20 U powder for solution for injection, intramuscularly, in equal aliquots to 5 injection sites (Point A [one injection in procerus muscle at crossing of two lines that connect Point B and contralateral caruncle], Point B [one injection on each side in central part of corrugator muscle approximately 1 cm above bony orbital rim on an imaginary line drawn vertically from caruncle], and Point C [one injection on each side in middle part of corrugator muscle at least 1.5 cm above bony orbital rim on an imaginary line drawn vertically from midpupillary line]) on Day 0 of Cycle 1. Re-injections based on investigator assessment were performed on Day 0 of subsequent cycles (up to 8 cycles for participants enrolled from MRZ 60201-0520/1 and MRZ 60201-0527/1; and up to 2 cycles for participants enrolled from MRZ 60201-0724/1 and MRZ 60201-0741/1). Each cycle length = 90 days.
10889623|NCT00512148|BG000|Baseline|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
10889624|NCT00512148|FG000|Participant Flow|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
10889625|NCT00512148|OG000|Outcome|All Implanted|The number of subjects implanted with the neobladder augment
10889626|NCT00512148|OG000|Outcome|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
10889627|NCT00512148|OG000|Outcome|Patients Treated|Tengion no longer exists following Chapter 7 bankruptcy in 2014. No data were analyzed.
11170927|NCT01999335|OG003|Outcome|Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
10889628|NCT00512148|EG000|Reported Event|Safety Population|Patients who underwent screening procedures and met inclusion/exclusion criteria.
11170928|NCT01999335|OG004|Outcome|Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170929|NCT01999335|OG000|Outcome|Oprozomib 150 mg 5/14 + Pomalidomide + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 or 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
11170930|NCT01999335|OG001|Outcome|Oprozomib 210 mg 2/7 + Pomalidomide + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
11170931|NCT01999335|OG002|Outcome|Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170932|NCT01999335|EG000|Reported Event|Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170933|NCT01999335|EG001|Reported Event|Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone|Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170934|NCT01999335|EG002|Reported Event|Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170935|NCT01999335|EG003|Reported Event|Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone|Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170936|NCT01999335|EG004|Reported Event|Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase|Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
11170937|NCT01999348|BG000|Baseline|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
11170938|NCT01999348|FG000|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
11170939|NCT01999348|OG000|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
11170940|NCT01999348|EG000|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
10889629|NCT00512252|BG000|Baseline|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
11170941|NCT01999400|BG000|Baseline|All Study Participants|"Participants who were randomized to one of the six arms of this study:~Arm 1: Pentasa then Delzicol then Apriso then Lialda Arm 2: Pentasa then Delzicol then Lialda then Apriso Arm 3: Apriso then Delzicol then Pentasa then Lialda Arm 4: Apriso then Delzicol then Lialda then Pentasa Arm 5: Lialda then Delzicol then Pentasa then Apriso Arm 6: Lialda then Delzicol then Apriso then Pentasa"
11170942|NCT01999400|FG000|Participant Flow|Arm 1: Pentasa Then Delzicol Then Apriso Then Lialda|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose."
11170943|NCT01999400|FG001|Participant Flow|Arm 2: Pentasa Then Delzicol Then Lialda Then Apriso|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose."
11170944|NCT01999400|FG002|Participant Flow|Arm 3: Apriso Then Delzicol Then Pentasa Then Lialda|"Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose."
11170945|NCT01999400|FG003|Participant Flow|Arm 4: Apriso Then Delzicol Then Lialda Then Pentasa|"Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose."
10889630|NCT00512252|BG001|Baseline|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
10889631|NCT00512252|BG002|Baseline|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
10889632|NCT00512252|BG003|Baseline|Total|Total of all reporting groups
10889633|NCT00512252|FG000|Participant Flow|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
10889634|NCT00512252|FG001|Participant Flow|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
10889635|NCT00512252|FG002|Participant Flow|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
10889636|NCT00512252|OG000|Outcome|Phase I Dose Escalation|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d~Dose Level 2 AMD3100 dose = 160 mcg/kg/d~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
10889637|NCT00512252|OG000|Outcome|First Relapse, First Salvage|
10889638|NCT00512252|OG001|Outcome|Primary Refractory|
11170946|NCT01999400|FG004|Participant Flow|Arm 5: Lialda Then Delzicol Then Pentasa Then Apriso|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose."
10889639|NCT00512252|OG002|Outcome|>= Second Relapse/Salvage|
10889640|NCT00512252|OG003|Outcome|Total|Phase II Dose Patients
10889641|NCT00512252|OG000|Outcome|Phase I Dose Escalation/Phase II Dose Treatment|
10889642|NCT00512252|OG000|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
10889643|NCT00512252|OG000|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
10889644|NCT00512252|OG001|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
10889645|NCT00512252|OG002|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
10889646|NCT00512252|EG000|Reported Event|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
10889647|NCT00512252|EG001|Reported Event|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
10889648|NCT00512252|EG002|Reported Event|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
10914719|NCT00632619|BG001|Baseline|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
10914720|NCT00632619|BG002|Baseline|Total|Total of all reporting groups
10914721|NCT00632619|FG000|Participant Flow|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
10914722|NCT00632619|FG001|Participant Flow|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
11170947|NCT01999400|FG005|Participant Flow|Arm 6: Lialda Then Delzicol Then Apriso Then Pentasa|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose."
11170948|NCT01999400|OG000|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
10889649|NCT00512278|BG000|Baseline|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
10889650|NCT00512278|BG001|Baseline|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study"
10889651|NCT00512278|BG002|Baseline|Total|Total of all reporting groups
10889652|NCT00512278|FG000|Participant Flow|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
10889653|NCT00512278|FG001|Participant Flow|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study"
10889654|NCT00512278|OG000|Outcome|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
10889655|NCT00512278|OG001|Outcome|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study"
10889656|NCT00512278|OG000|Outcome|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
10889657|NCT00512278|OG001|Outcome|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study"
11089968|NCT01526213|EG004|Reported Event|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
11089969|NCT01526213|EG005|Reported Event|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
10889658|NCT00512278|EG000|Reported Event|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
10889659|NCT00512278|EG001|Reported Event|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study"
10889660|NCT00512707|BG000|Baseline|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
10889661|NCT00512707|BG001|Baseline|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
10889662|NCT00512707|BG002|Baseline|Total|Total of all reporting groups
10889663|NCT00512707|FG000|Participant Flow|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
10889664|NCT00512707|FG001|Participant Flow|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
10889665|NCT00512707|OG000|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
10889666|NCT00512707|OG001|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
10889667|NCT00512707|EG000|Reported Event|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
10889668|NCT00512707|EG001|Reported Event|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
10889669|NCT00512798|BG000|Baseline|Phase I|
10889670|NCT00512798|BG001|Baseline|Phase II|
10889671|NCT00512798|BG002|Baseline|Total|Total of all reporting groups
10889672|NCT00512798|FG000|Participant Flow|Phase I|PS-341 will be administered intravenously at 1.0 mg/m2 of body weight beginning on days 1, 4, 8, and 11 of every 21 days. If toxicity occurs, dose will be lowered to 0.7 mg/m2. Dose can be raised to a maximum of 1.5 mg/m2. Temozolomide will be orally administered daily at 50 mg/m2 of body weight beginning on day 8 for 6 weeks of every 9-week cycle, followed by a 3-week rest. Minimum dose is 50 mg/m2 and maximum dose is 75 mg/m2.
10889673|NCT00512798|FG001|Participant Flow|Phase II|PS-341 and Temozolomide will be administered in the same manner as in Phase I at doses as determined by the Phase I portion of the trial.
11170949|NCT01999400|OG001|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
11170950|NCT01999400|OG002|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
11170951|NCT01999400|OG003|Outcome|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose~Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
11170952|NCT01999400|EG000|Reported Event|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
11170953|NCT01999400|EG001|Reported Event|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
11170954|NCT01999400|EG002|Reported Event|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
11170955|NCT01999400|EG003|Reported Event|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose~Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
11170956|NCT01999465|BG000|Baseline|Standard NMES Cohort|"Patients who will apply standard NMES device.~Standard NMES device: Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.~Rate(35 Hz)~Width (300 us)~Ch1 Ramp+ (2 seconds)~On Time 1 (10 seconds)~Ch1 Ramp - (2 seconds)"
11170957|NCT01999465|BG001|Baseline|Sham NMES Cohort|"Patients who will apply sham NMES device.~Sham NMES device: Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.~Rate(35 Hz)~Width (48 us)~Ch1 Ramp+ (0 seconds)~On Time 1 (0 seconds)~Ch1 Ramp - (0 seconds)"
11170958|NCT01999465|BG002|Baseline|Total|Total of all reporting groups
11170959|NCT01999465|FG000|Participant Flow|Standard NMES Cohort|"Patients who will apply standard NMES device.~Standard NMES device: Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.~Rate(35 Hz)~Width (300 us)~Ch1 Ramp+ (2 seconds)~On Time 1 (10 seconds)~Ch1 Ramp - (2 seconds)"
10889674|NCT00512798|OG000|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
10889675|NCT00512798|OG000|Outcome|Phase II|Phase II patients who were available for blood draw on the designated days.
10889676|NCT00512798|OG000|Outcome|Phase II|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior treatment with Dacarbazine or Temozolomide with treatment failure.
10889677|NCT00512798|EG000|Reported Event|Phase I|
10889678|NCT00512798|EG001|Reported Event|Phase II|
10889679|NCT00512876|BG000|Baseline|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
10889680|NCT00512876|FG000|Participant Flow|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
10889681|NCT00512876|OG000|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
10889682|NCT00512876|EG000|Reported Event|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye
10889683|NCT00512902|BG000|Baseline|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
10889684|NCT00512902|FG000|Participant Flow|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
10889685|NCT00512902|OG000|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
10889686|NCT00512902|EG000|Reported Event|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
10889687|NCT00513019|BG000|Baseline|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
10889688|NCT00513019|BG001|Baseline|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
10889689|NCT00513019|BG002|Baseline|Total|Total of all reporting groups
11233177|NCT02424630|BG000|Baseline|ISB With SSNB|"During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.~Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.~Arthroscopy-guided SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist."
10889690|NCT00513019|FG000|Participant Flow|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
10889691|NCT00513019|FG001|Participant Flow|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
10889692|NCT00513019|OG000|Outcome|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
10889693|NCT00513019|OG001|Outcome|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
10889694|NCT00513019|EG000|Reported Event|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
10889695|NCT00513019|EG001|Reported Event|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
10889696|NCT00513071|BG000|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
10889697|NCT00513071|FG000|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
10889698|NCT00513071|OG000|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
10889699|NCT00513071|EG000|Reported Event|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
10889700|NCT00513240|BG000|Baseline|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
10889701|NCT00513240|BG001|Baseline|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.~."
10889702|NCT00513240|BG002|Baseline|Total|Total of all reporting groups
10889703|NCT00513240|FG000|Participant Flow|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
10889704|NCT00513240|FG001|Participant Flow|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.~."
10889705|NCT00513240|OG000|Outcome|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
10889706|NCT00513240|OG001|Outcome|Placebo Group|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.~."
10889707|NCT00513240|OG000|Outcome|EPO 1000 Units/kg QDx3|Original dose of 1000 units/kg every day for 3 doses
10889708|NCT00513240|OG001|Outcome|EPO 500 Units/kg QODx3|Revised dose after FDA clinical hold removed of EPO 500 units/kg every other day for 3 doses
10889709|NCT00513240|OG002|Outcome|Placebo|Normal saline control
10889710|NCT00513240|EG000|Reported Event|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
10889711|NCT00513240|EG001|Reported Event|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.~."
10889712|NCT00513292|BG000|Baseline|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
10889713|NCT00513292|BG001|Baseline|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
10889714|NCT00513292|BG002|Baseline|Total|Total of all reporting groups
10889715|NCT00513292|FG000|Participant Flow|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
10889716|NCT00513292|FG001|Participant Flow|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
11089970|NCT01526343|BG000|Baseline|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
11089971|NCT01526343|FG000|Participant Flow|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
11089972|NCT01526343|OG000|Outcome|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
11089973|NCT01526343|EG000|Reported Event|Reveal XT|"Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.~No reportable adverse events occurred."
11089974|NCT01526356|BG000|Baseline|1% Rapamycin|"1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. High Dose"
11089975|NCT01526356|BG001|Baseline|0.1 % Rapamycin|"0.1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. Low Dose"
10889717|NCT00513292|OG000|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
10889718|NCT00513292|OG001|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
10889719|NCT00513292|EG000|Reported Event|Arm A|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
10889720|NCT00513292|EG001|Reported Event|Arm B|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
10889721|NCT00513305|BG000|Baseline|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
10889722|NCT00513305|BG001|Baseline|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
10889723|NCT00513305|BG002|Baseline|Total|Total of all reporting groups
10889724|NCT00513305|FG000|Participant Flow|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
10889725|NCT00513305|FG001|Participant Flow|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
11089976|NCT01526356|BG002|Baseline|Placebo|"Cream only~Placebo: Study cream is applied nightly to the affected areas on the face."
10889726|NCT00513305|OG000|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
10889727|NCT00513305|OG001|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
10889728|NCT00513305|EG000|Reported Event|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
10889729|NCT00513305|EG001|Reported Event|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
10889730|NCT00513344|BG000|Baseline|Entire Study Population|Includes groups randomized to receive control first, milk chocolate first, and dark chocolate first
10889731|NCT00513344|FG000|Participant Flow|Each Subject Tested the Three Products Randomly Following|"Before the 1st intervention, no food with polyphenols was admitted~Each subject was administered the three products randomly(one product per one-day intervention) according to the six possible sequencies:~Either dark chocolate first, then milk chocolate then control~or dark chocolate first, then control, then milk chocolate~or control first, then dark chocolate, then milk chocolate~or Control first, then milk chocolate, then dark chocolate~or Milk chocolate first, then control, then dark chocolate~or milk chocolate first, then dark chocolate, then control r dark chocolate was given once in the morning (1 day) Products were administered in the morning of the testing day. The testing days (interventions) were separated by a three-day wash-out period."
10889732|NCT00513344|OG000|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate~Control (polyphenol-free)"
10889733|NCT00513344|OG001|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate~Milk Chocolate : 1 portion"
11170960|NCT01999465|FG001|Participant Flow|Sham NMES Cohort|"Patients who will apply sham NMES device.~Sham NMES device: Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.~Rate(35 Hz)~Width (48 us)~Ch1 Ramp+ (0 seconds)~On Time 1 (0 seconds)~Ch1 Ramp - (0 seconds)"
10889734|NCT00513344|OG002|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate~Dark Chocolate : 1 portion"
10889735|NCT00513344|EG000|Reported Event|Dark Chocolate|
10889736|NCT00513344|EG001|Reported Event|Milk Chocolate|
10889737|NCT00513344|EG002|Reported Event|Control|
10889738|NCT00513357|BG000|Baseline|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
10889739|NCT00513357|BG001|Baseline|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
10889740|NCT00513357|BG002|Baseline|Total|Total of all reporting groups
10889741|NCT00513357|FG000|Participant Flow|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
10889742|NCT00513357|FG001|Participant Flow|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
11170961|NCT01999465|OG000|Outcome|Standard NMES Cohort|"Patients who will apply standard NMES device.~Standard NMES device: Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.~Rate(35 Hz)~Width (300 us)~Ch1 Ramp+ (2 seconds)~On Time 1 (10 seconds)~Ch1 Ramp - (2 seconds)"
11170962|NCT01999465|OG001|Outcome|Sham NMES Cohort|"Patients who will apply sham NMES device.~Sham NMES device: Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.~Rate(35 Hz)~Width (48 us)~Ch1 Ramp+ (0 seconds)~On Time 1 (0 seconds)~Ch1 Ramp - (0 seconds)"
10889743|NCT00513357|OG000|Outcome|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
10889744|NCT00513357|OG001|Outcome|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
10889745|NCT00513357|EG000|Reported Event|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
10889746|NCT00513357|EG001|Reported Event|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
10889747|NCT00513370|BG000|Baseline|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
10889748|NCT00513370|FG000|Participant Flow|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
10889749|NCT00513370|OG000|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
10889750|NCT00513370|OG001|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
10889751|NCT00513370|OG001|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
10889752|NCT00513370|EG000|Reported Event|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
10889753|NCT00513409|BG000|Baseline|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
10889754|NCT00513409|BG001|Baseline|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
10889755|NCT00513409|BG002|Baseline|Total|Total of all reporting groups
10889756|NCT00513409|FG000|Participant Flow|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
10889757|NCT00513409|FG001|Participant Flow|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
10889758|NCT00513409|OG000|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
10889759|NCT00513409|OG001|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
10889760|NCT00513409|EG000|Reported Event|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
10889761|NCT00513409|EG001|Reported Event|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
10889762|NCT00513435|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
10889763|NCT00513435|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
10889764|NCT00513435|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
10889765|NCT00513435|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
10889766|NCT00513461|BG000|Baseline|Arm I (SAMe)|"Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.~S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO~laboratory biomarker analysis: Correlative studies~immunoenzyme technique: Correlative studies~high performance liquid chromatography: Correlative studies"
10889767|NCT00513461|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies~immunoenzyme technique: Correlative studies~high performance liquid chromatography: Correlative studies"
10889768|NCT00513461|BG002|Baseline|Total|Total of all reporting groups
10889769|NCT00513461|FG000|Participant Flow|Arm I (SAMe)|"Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.~S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO~laboratory biomarker analysis: Correlative studies~immunoenzyme technique: Correlative studies~high performance liquid chromatography: Correlative studies"
10889770|NCT00513461|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies~immunoenzyme technique: Correlative studies~high performance liquid chromatography: Correlative studies"
10889771|NCT00513461|OG000|Outcome|Arm I (SAMe)|"Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.~S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO~laboratory biomarker analysis: Correlative studies~immunoenzyme technique: Correlative studies~high performance liquid chromatography: Correlative studies"
10889772|NCT00513461|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies~immunoenzyme technique: Correlative studies~high performance liquid chromatography: Correlative studies"
10889773|NCT00513461|EG000|Reported Event|Arm I (SAMe)|"Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.~S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO~laboratory biomarker analysis: Correlative studies~immunoenzyme technique: Correlative studies~high performance liquid chromatography: Correlative studies"
11089977|NCT01526356|BG003|Baseline|Total|Total of all reporting groups
10889774|NCT00513461|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies~immunoenzyme technique: Correlative studies~high performance liquid chromatography: Correlative studies"
10889775|NCT00513474|BG000|Baseline|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
10889776|NCT00513474|BG001|Baseline|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
10889777|NCT00513474|BG002|Baseline|Total|Total of all reporting groups
10889778|NCT00513474|FG000|Participant Flow|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
10889779|NCT00513474|FG001|Participant Flow|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
10889780|NCT00513474|OG000|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
10889781|NCT00513474|OG001|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
10889782|NCT00513474|EG000|Reported Event|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
10889783|NCT00513474|EG001|Reported Event|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
10889784|NCT00513500|BG000|Baseline|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
10889785|NCT00513500|BG001|Baseline|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
10889786|NCT00513500|BG002|Baseline|Total|Total of all reporting groups
10889787|NCT00513500|FG000|Participant Flow|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
10889788|NCT00513500|FG001|Participant Flow|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
11089978|NCT01526356|FG000|Participant Flow|1% Rapamycin|"1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. High Dose"
11089979|NCT01526356|FG001|Participant Flow|0.1 % Rapamycin|"0.1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. Low Dose"
11089980|NCT01526356|FG002|Participant Flow|Placebo|"Cream only~Placebo: Study cream is applied nightly to the affected areas on the face."
11089981|NCT01526356|OG000|Outcome|1% Rapamycin|"1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. High Dose"
11089982|NCT01526356|OG001|Outcome|0.1 % Rapamycin|"0.1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. Low Dose"
11089983|NCT01526356|OG002|Outcome|Placebo|"Cream only~Placebo: Study cream is applied nightly to the affected areas on the face."
11089984|NCT01526356|OG000|Outcome|Placebo|"Cream only~Placebo: Study cream is applied nightly to the affected areas on the face."
10889789|NCT00513500|OG000|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
10889790|NCT00513500|OG001|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
10889791|NCT00513500|EG000|Reported Event|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
10889792|NCT00513500|EG001|Reported Event|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
10889793|NCT00513526|BG000|Baseline|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
10889794|NCT00513526|FG000|Participant Flow|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
10889795|NCT00513526|OG000|Outcome|Gardasil|
10889796|NCT00513526|OG000|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
10889797|NCT00513526|OG000|Outcome|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
10889798|NCT00513526|EG000|Reported Event|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
10889799|NCT00513604|BG000|Baseline|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889800|NCT00513604|BG001|Baseline|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889801|NCT00513604|BG002|Baseline|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889802|NCT00513604|BG003|Baseline|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889803|NCT00513604|BG004|Baseline|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
10889804|NCT00513604|BG005|Baseline|Total|Total of all reporting groups
10889805|NCT00513604|FG000|Participant Flow|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889806|NCT00513604|FG001|Participant Flow|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
11089985|NCT01526356|OG002|Outcome|1% Rapamycin|"1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. High Dose"
11089986|NCT01526356|EG000|Reported Event|Placebo|"Cream only~Placebo: Study cream is applied nightly to the affected areas on the face."
11170963|NCT01999465|EG000|Reported Event|Standard NMES Cohort|"Patients who will apply standard NMES device.~Standard NMES device: Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.~Rate(35 Hz)~Width (300 us)~Ch1 Ramp+ (2 seconds)~On Time 1 (10 seconds)~Ch1 Ramp - (2 seconds)"
10849991|NCT00299494|OG005|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
11233178|NCT02424630|BG001|Baseline|ISB Alone|"During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.~Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.~Placebo"
10889807|NCT00513604|FG002|Participant Flow|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889808|NCT00513604|FG003|Participant Flow|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889809|NCT00513604|FG004|Participant Flow|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
10889810|NCT00513604|OG000|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889811|NCT00513604|OG001|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889812|NCT00513604|OG002|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889813|NCT00513604|OG003|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889814|NCT00513604|OG004|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
10889815|NCT00513604|EG000|Reported Event|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889816|NCT00513604|EG001|Reported Event|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
11089987|NCT01526356|EG001|Reported Event|0.1 % Rapamycin|"0.1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. Low Dose"
11089988|NCT01526356|EG002|Reported Event|1% Rapamycin|"1% Rapamycin cream~Rapamycin: Study cream is applied nightly to the affected areas on the face. High Dose"
11233179|NCT02424630|BG002|Baseline|Total|Total of all reporting groups
10889817|NCT00513604|EG002|Reported Event|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889818|NCT00513604|EG003|Reported Event|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
10889819|NCT00513604|EG004|Reported Event|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
10889820|NCT00513682|BG000|Baseline|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
10889821|NCT00513682|FG000|Participant Flow|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
10889822|NCT00513682|OG000|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
10889823|NCT00513682|OG001|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
10889824|NCT00513682|EG000|Reported Event|Ultrase® MT20 Screening Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea.
10889825|NCT00513682|EG001|Reported Event|Ultrase® MT20 Washout Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent a washout phase, of 6 to 7 days, in which participants received only high-fat diet and refrained from taking Ultrase® MT20.
10889826|NCT00513682|EG002|Reported Event|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
10889827|NCT00513695|BG000|Baseline|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
10889828|NCT00513695|FG000|Participant Flow|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
11089989|NCT01526538|BG000|Baseline|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
11089990|NCT01526538|BG001|Baseline|Sugar Pill|"Inactive placebo~sugar pill: placebo"
11089991|NCT01526538|BG002|Baseline|Total|Total of all reporting groups
11089992|NCT01526538|FG000|Participant Flow|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
11089993|NCT01526538|FG001|Participant Flow|Sugar Pill|"Inactive placebo~sugar pill: placebo"
11089994|NCT01526538|OG000|Outcome|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
11089995|NCT01526538|OG001|Outcome|Sugar Pill|"Inactive placebo~sugar pill: placebo"
11089996|NCT01526538|OG000|Outcome|D-cycloserine|Study medication under investigation
11089997|NCT01526538|OG001|Outcome|Control|Placebo (sugar pill)
11089998|NCT01526538|EG000|Reported Event|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
11089999|NCT01526538|EG001|Reported Event|Sugar Pill|"Inactive placebo~sugar pill: placebo"
11090000|NCT01526551|BG000|Baseline|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
11090001|NCT01526551|FG000|Participant Flow|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
10851288|NCT00305682|FG004|Participant Flow|Arm 5 - Previous Autologous Transplant|Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851289|NCT00305682|FG005|Participant Flow|Arm 6 - No Prior Autologous Transplant|Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851290|NCT00305682|OG000|Outcome|Arm 1-Previous Autologous Transplant|hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851291|NCT00305682|OG001|Outcome|Arm 2 - No Prior Autologous Transplant|Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851292|NCT00305682|OG002|Outcome|Arm 3 - Refractory Leukemia/Lymphoma|Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851293|NCT00305682|OG003|Outcome|Arm 4: MT2006-01 Coenrolling Patients|Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851294|NCT00305682|OG004|Outcome|Arm 5 - Previous Autologous Transplant|Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851295|NCT00305682|OG005|Outcome|Arm 6 - No Prior Autologous Transplant|Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851296|NCT00305682|EG000|Reported Event|Arm 1-Previous Autologous Transplant|hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851297|NCT00305682|EG001|Reported Event|Arm 2 - No Prior Autologous Transplant|Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851298|NCT00305682|EG002|Reported Event|Arm 3 - Refractory Leukemia/Lymphoma|Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10851299|NCT00305682|EG003|Reported Event|Arm 4: MT2006-01 Coenrolling Patients|Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10889829|NCT00513695|OG000|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
10889830|NCT00513695|EG000|Reported Event|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
10889831|NCT00513708|BG000|Baseline|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
10889832|NCT00513708|BG001|Baseline|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
10889833|NCT00513708|BG002|Baseline|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
10889834|NCT00513708|BG003|Baseline|Total|Total of all reporting groups
10889835|NCT00513708|FG000|Participant Flow|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
10889836|NCT00513708|FG001|Participant Flow|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
10889837|NCT00513708|FG002|Participant Flow|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
10889838|NCT00513708|OG000|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
10889839|NCT00513708|OG001|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
10889840|NCT00513708|OG002|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
10889841|NCT00513708|EG000|Reported Event|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
10889842|NCT00513708|EG001|Reported Event|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
10889843|NCT00513708|EG002|Reported Event|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
10889844|NCT00513747|BG000|Baseline|Arm A: High Risk Early Intervention|Randomized Patients receive 50, 325, and 375 mg/m^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m^2 rituximab IV on day 1 of weeks 5, 9, 13,> 17, and 21. Patients also receive 25 mg/m^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889845|NCT00513747|BG001|Baseline|Arm B: High Risk Observation + Later Treatment|Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
11233180|NCT02424630|FG000|Participant Flow|ISB With SSNB|"During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.~Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.~Arthroscopy-guided SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist."
11170964|NCT01999465|EG001|Reported Event|Sham NMES Cohort|"Patients who will apply sham NMES device.~Sham NMES device: Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.~Rate(35 Hz)~Width (48 us)~Ch1 Ramp+ (0 seconds)~On Time 1 (0 seconds)~Ch1 Ramp - (0 seconds)"
11170965|NCT01999517|BG000|Baseline|Intravenous Nitroglycerin|Intravenous Nitroglycerin with IV Fluids
11170966|NCT01999517|BG001|Baseline|Placebo|IV Fluids
11170967|NCT01999517|BG002|Baseline|Total|Total of all reporting groups
11170968|NCT01999517|FG000|Participant Flow|Intravenous Nitroglycerin|Intravenous Nitroglycerin with IV Fluids
11170969|NCT01999517|FG001|Participant Flow|Placebo|IV Fluids
11170970|NCT01999517|OG000|Outcome|Intravenous Nitroglycerin|"IV Nitroglycerin with IV Fluids~Intravenous Nitroglycerin~IV Fluids"
11170971|NCT01999517|OG001|Outcome|Placebo|"IV Fluids~IV Fluids"
11170972|NCT01999517|EG000|Reported Event|Intravenous Nitroglycerin|Intravenous Nitroglycerin with IV Fluids
11170973|NCT01999517|EG001|Reported Event|Placebo|IV Fluids
11170974|NCT01999530|BG000|Baseline|Prazosin Hydrochloride|"Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks.~Prazosin Hydrochloride: Gradual upward titration to 15mg/day for approximately three weeks."
11170975|NCT01999530|FG000|Participant Flow|Prazosin Hydrochloride|"Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks.~Prazosin Hydrochloride: Gradual upward titration to 15mg/day for approximately three weeks."
10889846|NCT00513747|BG002|Baseline|Arm C: Low Risk Observation + Later Treatment|Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
11170976|NCT01999530|OG000|Outcome|Prazosin Hydrochloride|"Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks.~Prazosin Hydrochloride: Gradual upward titration to 15mg/day for approximately three weeks."
11170977|NCT01999530|EG000|Reported Event|Prazosin Hydrochloride|"Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks.~Prazosin Hydrochloride: Gradual upward titration to 15mg/day for approximately three weeks."
11170978|NCT01999777|BG000|Baseline|USL261|"5 mg intranasal midazolam~USL261"
11170979|NCT01999777|BG001|Baseline|Placebo|"intranasal placebo~Placebo"
11170980|NCT01999777|BG002|Baseline|Total|Total of all reporting groups
11170981|NCT01999777|FG000|Participant Flow|USL261|"5 mg intranasal midazolam~USL261"
11170982|NCT01999777|FG001|Participant Flow|Placebo|"intranasal placebo~Placebo"
11170983|NCT01999777|OG000|Outcome|USL261|"5 mg intranasal midazolam~USL261"
11170984|NCT01999777|OG001|Outcome|Placebo|"intranasal placebo~Placebo"
11170985|NCT01999777|EG000|Reported Event|USL261|"5 mg intranasal midazolam~USL261"
11170986|NCT01999777|EG001|Reported Event|Placebo|"intranasal placebo~Placebo"
11170987|NCT01999868|BG000|Baseline|Ustekinumab, Abatacept + Ustekinumab Placebo|Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
11170988|NCT01999868|BG001|Baseline|Ustekinumab, Ustekinumab + Abatacept Placebo|Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
11170989|NCT01999868|BG002|Baseline|Ustekinumab, Not Randomized|Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase but were not randomized to a blinded treatment group.
11170990|NCT01999868|BG003|Baseline|Total|Total of all reporting groups
11170991|NCT01999868|FG000|Participant Flow|Ustekinumab, Abatacept + Ustekinumab Placebo|Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
11170992|NCT01999868|FG001|Participant Flow|Ustekinumab, Ustekinumab + Abatacept Placebo|Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
11170993|NCT01999868|FG002|Participant Flow|Ustekinumab, Not Randomized|Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase but were not randomized to a blinded treatment group.
11170994|NCT01999868|OG000|Outcome|Ustekinumab, Abatacept + Ustekinumab Placebo|Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
10889847|NCT00513747|BG003|Baseline|Total|Total of all reporting groups
10889848|NCT00513747|FG000|Participant Flow|Arm A: High Risk Early Intervention|"Randomized Patients receive 50, 325, and 375 mg/m^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m^2 rituximab IV on day 1 of weeks 5, 9, 13,~> 17, and 21. Patients also receive 25 mg/m^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen."
10889849|NCT00513747|FG001|Participant Flow|Arm B: High Risk Observation + Later Treatment|Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889850|NCT00513747|FG002|Participant Flow|Arm C: Low Risk Observation + Later Treatment|Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889851|NCT00513747|OG000|Outcome|Arm A: High Risk Early Intervention|Randomized Patients receive 50, 325, and 375 mg/m^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m^2 rituximab IV on day 1 of weeks 5, 9, 13,> 17, and 21. Patients also receive 25 mg/m^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889852|NCT00513747|OG001|Outcome|Arm B: High Risk Observation + Later Treatment|Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889853|NCT00513747|OG002|Outcome|Arm C: Low Risk Observation + Later Treatment|Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889854|NCT00513747|OG003|Outcome|Total|Arm A + Arm B + Arm C patients
11335587|NCT03553758|OG000|Outcome|Ketamine|"15 subjects undergoing ketamine general anesthesia.~Ketamine: Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."
10889855|NCT00513747|OG000|Outcome|Arm C: Low Risk Observation + Later Treatment|Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889856|NCT00513747|EG000|Reported Event|Arm A: High Risk Early Intervention|Randomized Patients receive 50, 325, and 375 mg/m^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m^2 rituximab IV on day 1 of weeks 5, 9, 13, > 17, and 21. Patients also receive 25 mg/m^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889857|NCT00513747|EG001|Reported Event|Arm B: High Risk Observation + Later Treatment|Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889858|NCT00513747|EG002|Reported Event|Arm C: Low Risk Observation + Later Treatment|Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
10889859|NCT00513799|BG000|Baseline|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
10889860|NCT00513799|BG001|Baseline|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
10889861|NCT00513799|BG002|Baseline|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
10889862|NCT00513799|BG003|Baseline|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
10889863|NCT00513799|BG004|Baseline|Total|Total of all reporting groups
10889864|NCT00513799|FG000|Participant Flow|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
10889865|NCT00513799|FG001|Participant Flow|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
10889866|NCT00513799|FG002|Participant Flow|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
10889867|NCT00513799|FG003|Participant Flow|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
11170995|NCT01999868|OG001|Outcome|Ustekinumab, Ustekinumab + Abatacept Placebo|Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
11170996|NCT01999868|OG000|Outcome|Safety|The safety population includes all participants who received at least one dose of treatment after enrollment.
10889868|NCT00513799|OG000|Outcome|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
10889869|NCT00513799|OG001|Outcome|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
10889870|NCT00513799|OG002|Outcome|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
10889871|NCT00513799|OG003|Outcome|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
10889872|NCT00513799|OG000|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
10889873|NCT00513799|OG001|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
10889874|NCT00513799|OG002|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
10889875|NCT00513799|OG003|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
10889876|NCT00513799|EG000|Reported Event|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
10889877|NCT00513799|EG001|Reported Event|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
10889878|NCT00513799|EG002|Reported Event|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
10889879|NCT00513799|EG003|Reported Event|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
10889880|NCT00514020|BG000|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10889881|NCT00514020|FG000|Participant Flow|5-FU, Leucovorin, Oxaliplatin|"Patients who have TSER*2/*2 or TSER*2/*3 genotypes will receive the modified FOLFOX-6 treatment. Patients homozygous for TSER*3 will not be included in study.~FOLFOX-6 chemotherapy: oxaliplatin IV in 500 ml D5W over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.~Treatment courses repeat every 2 weeks +/- 3 days (2 treatments per cycle) in the absence of unacceptable toxicity or disease progression. Disease assessments will be performed after 8 weeks (2 cycles) of treatment."
10889882|NCT00514020|OG000|Outcome|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10889883|NCT00514020|EG000|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
10889884|NCT00514046|BG000|Baseline|Vandetanib: First 100 mg/m^2, Then 150 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2.
10889885|NCT00514046|BG001|Baseline|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 67 mg/m^2.
10889886|NCT00514046|BG002|Baseline|Vandetanib 100 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day.
10889887|NCT00514046|BG003|Baseline|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 100 mg/m^2.
11170997|NCT01999868|EG000|Reported Event|UST Open Label|Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase.
10889888|NCT00514046|BG004|Baseline|Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 63 mg/m^2, then 42 mg/m^2, then 21 mg/m^2, then 42 mg/m^2, followed by 21 mg/m^2.
10889889|NCT00514046|BG005|Baseline|Vandetanib: First 100 mg/m^2, Then 70 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 70 mg/m^2.
10889890|NCT00514046|BG006|Baseline|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 200 mg/m^2.
10889891|NCT00514046|BG007|Baseline|Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, then 100 mg/m^2, then 150 mg/m^2, then 100 mg/m^2, followed by 150 mg/m^2.
10889892|NCT00514046|BG008|Baseline|Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m^2/day, then 100 mg/m^2.
10889893|NCT00514046|BG009|Baseline|Total|Total of all reporting groups
10889894|NCT00514046|FG000|Participant Flow|Vandetanib: First 100 mg/m^2, Then 150 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2.
10889895|NCT00514046|FG001|Participant Flow|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 67 mg/m^2.
10889896|NCT00514046|FG002|Participant Flow|Vandetanib 100 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day.
10889897|NCT00514046|FG003|Participant Flow|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 100 mg/m^2.
10889898|NCT00514046|FG004|Participant Flow|Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 63 mg/m^2, then 42 mg/m^2, then 21 mg/m^2, then 42 mg/m^2, followed by 21 mg/m^2.
10889899|NCT00514046|FG005|Participant Flow|Vandetanib: First 100 mg/m^2, Then 70 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 70 mg/m^2.
10889900|NCT00514046|FG006|Participant Flow|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 200 mg/m^2.
10889901|NCT00514046|FG007|Participant Flow|Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, then 100 mg/m^2, then 150 mg/m^2, then 100 mg/m^2, followed by 150 mg/m^2.
10889902|NCT00514046|FG008|Participant Flow|Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m^2/day, then 100 mg/m^2.
10889903|NCT00514046|OG000|Outcome|All Participants|All participants who received Vandetanib 100mg/m^2 and 150mg/m^2.
10889904|NCT00514046|OG000|Outcome|Vandetanib: First 100 mg/m^2, Then 150 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2.
10889905|NCT00514046|OG001|Outcome|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 67 mg/m^2.
10889906|NCT00514046|OG002|Outcome|Vandetanib 100 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day.
10889907|NCT00514046|OG003|Outcome|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 100 mg/m^2.
10889908|NCT00514046|OG004|Outcome|Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 63 mg/m^2, then 42 mg/m^2, then 21 mg/m^2, then 42 mg/m^2, followed by 21 mg/m^2.
10889909|NCT00514046|OG005|Outcome|Vandetanib: First 100 mg/m^2, Then 70 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 70 mg/m^2.
10889910|NCT00514046|OG006|Outcome|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 200 mg/m^2.
11170998|NCT01999868|EG001|Reported Event|Post Randomization: UST, ABA/UST Placebo|Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (ABA) (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
10889911|NCT00514046|OG007|Outcome|Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, then 100 mg/m^2, then 150 mg/m^2, then 100 mg/m^2, followed by 150 mg/m^2.
10889912|NCT00514046|OG008|Outcome|Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m^2/day, then 100 mg/m^2.
10889913|NCT00514046|OG000|Outcome|All Participants|All participants who received Vandetanib 100mg/m^2 during the first cycle.
10889914|NCT00514046|EG000|Reported Event|Vandetanib: First 100 mg/m^2, Then 150 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2.
10889915|NCT00514046|EG001|Reported Event|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 67 mg/m^2.
10889916|NCT00514046|EG002|Reported Event|Vandetanib 100 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day.
10889917|NCT00514046|EG003|Reported Event|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 100 mg/m^2.
10889918|NCT00514046|EG004|Reported Event|Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 63 mg/m^2, then 42 mg/m^2, then 21 mg/m^2, then 42 mg/m^2, followed by 21 mg/m^2.
10889919|NCT00514046|EG005|Reported Event|Vandetanib: First 100 mg/m^2, Then 70 mg/m^2|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 70 mg/m^2.
10889920|NCT00514046|EG006|Reported Event|Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, followed by 200 mg/m^2.
10889921|NCT00514046|EG007|Reported Event|Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m^2/day, then 150 mg/m^2, then 100 mg/m^2, then 150 mg/m^2, then 100 mg/m^2, followed by 150 mg/m^2.
10889922|NCT00514046|EG008|Reported Event|Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg|All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m^2/day, then 100 mg/m^2.
10889923|NCT00514137|BG000|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10889924|NCT00514137|FG000|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10889925|NCT00514137|OG000|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10889926|NCT00514137|EG000|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10889927|NCT00514215|BG000|Baseline|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
10889928|NCT00514215|FG000|Participant Flow|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
10889929|NCT00514215|OG000|Outcome|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
10889930|NCT00514215|EG000|Reported Event|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
10889931|NCT00514449|BG000|Baseline|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
10889932|NCT00514449|BG001|Baseline|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
10889933|NCT00514449|BG002|Baseline|Total|Total of all reporting groups
11170999|NCT01999868|EG002|Reported Event|Post Randomization: UST, UST/ABA Placebo|Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept (ABA) placebo subcutaneous injections weekly from Week 12 to 39.
10889934|NCT00514449|FG000|Participant Flow|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
10889935|NCT00514449|FG001|Participant Flow|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
10889936|NCT00514449|OG000|Outcome|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks
10889937|NCT00514449|OG001|Outcome|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
10889938|NCT00514449|OG000|Outcome|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
10889939|NCT00514449|OG000|Outcome|Valacyclovir|A time by treatment group interaction showed increased gray matter volume estimated as number of voxels in a cluster with Valaclcovir compared to placebo
10889940|NCT00514449|OG001|Outcome|Sugar Pill|A time by treatment group interaction showed decreased or no significant change in the gray matter volume estimated as number of voxels in a cluster with Valaclcovir compared to placebo
10889941|NCT00514449|EG000|Reported Event|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
10889942|NCT00514449|EG001|Reported Event|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
10889943|NCT00514501|BG000|Baseline|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
10889944|NCT00514501|FG000|Participant Flow|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
10889945|NCT00514501|OG000|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
10889946|NCT00514501|EG000|Reported Event|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
10889947|NCT00514514|BG000|Baseline|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
10889948|NCT00514514|BG001|Baseline|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
10889949|NCT00514514|BG002|Baseline|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
10889950|NCT00514514|BG003|Baseline|Total|Total of all reporting groups
10889951|NCT00514514|FG000|Participant Flow|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
10889952|NCT00514514|FG001|Participant Flow|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
10889953|NCT00514514|FG002|Participant Flow|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
10889954|NCT00514514|OG000|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
10889955|NCT00514514|OG001|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
11171000|NCT01999894|BG000|Baseline|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
10889956|NCT00514514|OG002|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
10889957|NCT00514514|EG000|Reported Event|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
10889958|NCT00514514|EG001|Reported Event|CNI-free|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids"
10889959|NCT00514514|EG002|Reported Event|CNI-low|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
10889960|NCT00514540|BG000|Baseline|First-Line CD + Second-Line EP|"First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1. Repeated every 3 weeks. Colony stimulating factors given prophylactically per National Comprehensive Cancer Network (NCCN) guidelines.~Second-Line (EP) Chemotherapy: Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks."
10889961|NCT00514540|FG000|Participant Flow|Chemotherapy First-Line Chemo (CD) + Second-Line (EP)|"First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1. Repeated every 3 weeks. Colony stimulating factors given prophylactically per National Comprehensive Cancer Network (NCCN) guidelines.~Second-Line (EP) Chemotherapy: Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks."
10889962|NCT00514540|OG000|Outcome|First-Line: Carboplatin + Docetaxel|Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1 repeated every 3 weeks.
11171001|NCT01999894|FG000|Participant Flow|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
11171002|NCT01999894|OG000|Outcome|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
11171003|NCT01999894|EG000|Reported Event|Placebo to Memantine|Patients who received placebo during the double-blind lead-in study, were titrated to Memantine during a 6-week lead-in to 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
10889963|NCT00514540|OG001|Outcome|Second-Line: Etoposide + Cisplatin|Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
10889964|NCT00514540|OG000|Outcome|Second-Line: EP, Course 1|Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
10889965|NCT00514540|OG001|Outcome|Second-Line: EP, Course 2|Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
10889966|NCT00514540|EG000|Reported Event|First-Line: Carboplatin + Docetaxel|Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m2 IV over 60 minutes, Day 1 repeated every 3 weeks
10889967|NCT00514540|EG001|Reported Event|Second Line: Etoposide + Cisplatin|Etoposide 120 mg/m2 daily for 3 days and Cisplatin 25 mg/m2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics), Repeated every 3 weeks.
10889968|NCT00514592|BG000|Baseline|All Patients|All patients are in the same group
10889969|NCT00514592|FG000|Participant Flow|All Patients|All patients enter the same group
10889970|NCT00514592|OG000|Outcome|All Patients|All patients enter the same group
10889971|NCT00514592|EG000|Reported Event|All Patients|All patients enter the same group
10889972|NCT00514683|BG000|Baseline|Placebo|Patients were treated with matching Placebo.
10889973|NCT00514683|BG001|Baseline|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
10889974|NCT00514683|BG002|Baseline|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
10889975|NCT00514683|BG003|Baseline|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
10889976|NCT00514683|BG004|Baseline|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
10889977|NCT00514683|BG005|Baseline|Total|Total of all reporting groups
10889978|NCT00514683|FG000|Participant Flow|Placebo|Patients were treated with matching Placebo.
10889979|NCT00514683|FG001|Participant Flow|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
10889980|NCT00514683|FG002|Participant Flow|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
10889981|NCT00514683|FG003|Participant Flow|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
10889982|NCT00514683|FG004|Participant Flow|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
10889983|NCT00514683|OG000|Outcome|Placebo|Patients were treated with matching Placebo.
10889984|NCT00514683|OG001|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
10889985|NCT00514683|OG002|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
10889986|NCT00514683|OG003|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
10889987|NCT00514683|OG004|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
10889988|NCT00514683|OG000|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
10889989|NCT00514683|OG001|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
10889990|NCT00514683|OG002|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
10889991|NCT00514683|OG003|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
10889992|NCT00514683|EG000|Reported Event|Placebo|Patients were treated with matching Placebo.
10889993|NCT00514683|EG001|Reported Event|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
10889994|NCT00514683|EG002|Reported Event|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
10889995|NCT00514683|EG003|Reported Event|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
10889996|NCT00514683|EG004|Reported Event|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
10889997|NCT00514709|BG000|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
10889998|NCT00514709|BG001|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
10889999|NCT00514709|BG002|Baseline|Total|Total of all reporting groups
11171004|NCT01999894|EG001|Reported Event|Memantine to Memantine|Patients who received Memantine during the double-blind lead-in study continued to receive Memantine during a 6-week lead-in, followed by 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
10890000|NCT00514709|FG000|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
10890001|NCT00514709|FG001|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
10890002|NCT00514709|OG000|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
10890003|NCT00514709|OG001|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
10890004|NCT00514709|OG000|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP-T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
10890005|NCT00514709|OG001|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
10890006|NCT00514709|EG000|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
10890007|NCT00514709|EG001|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
10890008|NCT00514735|BG000|Baseline|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
10890009|NCT00514735|BG001|Baseline|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
10890010|NCT00514735|BG002|Baseline|Total|Total of all reporting groups
10890011|NCT00514735|FG000|Participant Flow|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
10890012|NCT00514735|FG001|Participant Flow|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
10890013|NCT00514735|OG000|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
10890014|NCT00514735|OG001|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
10890015|NCT00514735|OG000|Outcome|Ablation Management|
10890016|NCT00514735|OG001|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
10890017|NCT00514735|EG000|Reported Event|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
10890018|NCT00514735|EG001|Reported Event|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
10890019|NCT00514852|BG000|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
10890020|NCT00514852|BG001|Baseline|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
10890021|NCT00514852|BG002|Baseline|Total|Total of all reporting groups
10890022|NCT00514852|FG000|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
10890023|NCT00514852|FG001|Participant Flow|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
10890024|NCT00514852|OG000|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
10890025|NCT00514852|OG001|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
10890026|NCT00514852|EG000|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
11171005|NCT01999920|BG000|Baseline|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
10890027|NCT00514852|EG001|Reported Event|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
10890028|NCT00514904|BG000|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
11171006|NCT01999920|BG001|Baseline|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
11171007|NCT01999920|BG002|Baseline|Total|Total of all reporting groups
10890029|NCT00514904|BG001|Baseline|Mencevax ACWY Group|Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
10890030|NCT00514904|BG002|Baseline|Total|Total of all reporting groups
10890031|NCT00514904|FG000|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10890032|NCT00514904|FG001|Participant Flow|Mencevax ACWY Group|Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
10890033|NCT00514904|OG000|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10890034|NCT00514904|OG001|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
10890035|NCT00514904|EG000|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10890036|NCT00514904|EG001|Reported Event|Mencevax ACWY Group|Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
10890037|NCT00514917|BG000|Baseline|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890038|NCT00514917|BG001|Baseline|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890039|NCT00514917|BG002|Baseline|Total|Total of all reporting groups
10890040|NCT00514917|FG000|Participant Flow|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890041|NCT00514917|FG001|Participant Flow|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890042|NCT00514917|OG000|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890043|NCT00514917|OG001|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890044|NCT00514917|OG000|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles along with leuprolide 22.5 mg/m^2subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890045|NCT00514917|OG001|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg/m^2 subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890046|NCT00514917|EG000|Reported Event|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890047|NCT00514917|EG001|Reported Event|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
10890048|NCT00514943|BG000|Baseline|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
10890049|NCT00514943|BG001|Baseline|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
10890050|NCT00514943|BG002|Baseline|Total|Total of all reporting groups
10890051|NCT00514943|FG000|Participant Flow|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
10890052|NCT00514943|FG001|Participant Flow|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
11171008|NCT01999920|FG000|Participant Flow|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
11171009|NCT01999920|FG001|Participant Flow|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
10890053|NCT00514943|OG000|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
10890054|NCT00514943|OG001|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
10890055|NCT00514943|OG000|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
10890056|NCT00514943|OG001|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
10890057|NCT00514943|OG000|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
11171010|NCT01999920|OG000|Outcome|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
10890058|NCT00514943|OG001|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
10890059|NCT00514943|OG000|Outcome|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
10890060|NCT00514943|OG001|Outcome|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
10890061|NCT00514943|OG000|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
10890062|NCT00514943|OG001|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
10890063|NCT00514943|OG002|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
10890064|NCT00514943|OG003|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
10890065|NCT00514943|OG001|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
10890066|NCT00514943|OG000|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
10890067|NCT00514943|OG001|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
11171011|NCT01999920|OG001|Outcome|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
11171012|NCT01999920|EG000|Reported Event|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
10890068|NCT00514943|EG000|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
10890069|NCT00514943|EG001|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
10890070|NCT00514943|EG002|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
10890071|NCT00514943|EG003|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 1|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
10890072|NCT00515008|BG000|Baseline|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
10890073|NCT00515008|BG001|Baseline|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
10890074|NCT00515008|BG002|Baseline|Total|Total of all reporting groups
10890075|NCT00515008|FG000|Participant Flow|Tai Chi Group|12-week Tai Chi Program.: The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
10890076|NCT00515008|FG001|Participant Flow|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program. Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks. At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management. For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day.
10914723|NCT00632619|OG000|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
10890077|NCT00515008|OG000|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai~chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
10890078|NCT00515008|OG001|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
10890079|NCT00515008|OG000|Outcome|Tai Chi|The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
10890080|NCT00515008|OG000|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
10890081|NCT00515008|OG001|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
10890082|NCT00515008|EG000|Reported Event|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
10890083|NCT00515008|EG001|Reported Event|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
10890084|NCT00515021|BG000|Baseline|Eplerenone: Morning Administration Then Evening|"Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks~Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg"
10890085|NCT00515021|BG001|Baseline|Eplerenone: Evening Administration Then Morning|"Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks~Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks"
10890086|NCT00515021|BG002|Baseline|Total|Total of all reporting groups
10890087|NCT00515021|FG000|Participant Flow|Eplerenone: Morning Administration Then Evening|"Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks~Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg"
10890088|NCT00515021|FG001|Participant Flow|Eplerenone: Evening Administration Then Morning|"Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks~Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks"
10890089|NCT00515021|OG000|Outcome|Eplerenone: Morning Administration Then Evening|"Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks~Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg"
10890090|NCT00515021|OG001|Outcome|Eplerenone: Evening Administration Then Morning|"Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks~Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks"
10890091|NCT00515021|OG000|Outcome|Eplerenone: Morning Administration|Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks
10890092|NCT00515021|OG001|Outcome|Eplerenone: Night-time Administration|Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks
10890093|NCT00515021|EG000|Reported Event|Eplerenone: Morning Administration Then Evening|"Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks~Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg"
10890094|NCT00515021|EG001|Reported Event|Eplerenone: Evening Administration Then Morning|"Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks~Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks"
10890095|NCT00515034|BG000|Baseline|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
10890096|NCT00515034|BG001|Baseline|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
10890097|NCT00515034|BG002|Baseline|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
10890098|NCT00515034|BG003|Baseline|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
10890099|NCT00515034|BG004|Baseline|Total|Total of all reporting groups
10890100|NCT00515034|FG000|Participant Flow|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
10890101|NCT00515034|FG001|Participant Flow|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
10890102|NCT00515034|FG002|Participant Flow|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
10890103|NCT00515034|FG003|Participant Flow|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
10890104|NCT00515034|OG000|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
10890105|NCT00515034|OG001|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
10890106|NCT00515034|OG002|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
10890107|NCT00515034|OG003|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
10890108|NCT00515034|EG000|Reported Event|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
10890109|NCT00515034|EG001|Reported Event|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
10890110|NCT00515034|EG002|Reported Event|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
10890111|NCT00515034|EG003|Reported Event|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
10890112|NCT00515073|BG000|Baseline|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
10890113|NCT00515073|FG000|Participant Flow|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
10890114|NCT00515073|OG000|Outcome|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
10890115|NCT00515073|EG000|Reported Event|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
10890116|NCT00515086|BG000|Baseline|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
10890117|NCT00515086|BG001|Baseline|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890118|NCT00515086|BG002|Baseline|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890119|NCT00515086|BG003|Baseline|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890120|NCT00515086|BG004|Baseline|Total|Total of all reporting groups
11171013|NCT01999920|EG001|Reported Event|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
10890121|NCT00515086|FG000|Participant Flow|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
10890122|NCT00515086|FG001|Participant Flow|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890123|NCT00515086|FG002|Participant Flow|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890124|NCT00515086|FG003|Participant Flow|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890125|NCT00515086|OG000|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890126|NCT00515086|OG001|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890127|NCT00515086|OG002|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890128|NCT00515086|OG000|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
10890129|NCT00515086|OG001|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
10890130|NCT00515086|OG003|Outcome|Total|All the participants scheduled to undergo salvage surgical resection from three pre-surgery treatment groups (i.e 0, 5 or 10 mg/day (once daily) everolimus X 7 days).
10890131|NCT00515086|OG000|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890132|NCT00515086|OG001|Outcome|Everolimus 5mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890133|NCT00515086|OG001|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme (GBM) with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
10890134|NCT00515086|OG002|Outcome|Total : No Surgery|Total participants enrolled with recurrent glioblastoma multiforme (GBM) who were not scheduled to undergo a planned salvage surgical resection. All participants in this arm were to receive a fixed daily dose of 10 mg/day oral everolimus.
10890135|NCT00515086|EG000|Reported Event|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890136|NCT00515086|EG001|Reported Event|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890137|NCT00515086|EG002|Reported Event|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
10890138|NCT00515086|EG003|Reported Event|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
10890139|NCT00515099|BG000|Baseline|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
11171014|NCT01999946|BG000|Baseline|Extended-Release Naltrexone (XR-NTX)|"Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection."
11171015|NCT01999946|BG001|Baseline|Enhanced Treatment As Usual (ETAU)|Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
10890140|NCT00515099|BG001|Baseline|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
10890141|NCT00515099|BG002|Baseline|Total|Total of all reporting groups
10890142|NCT00515099|FG000|Participant Flow|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
10890143|NCT00515099|FG001|Participant Flow|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
10890144|NCT00515099|OG000|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
10890145|NCT00515099|OG001|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
10890146|NCT00515099|EG000|Reported Event|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
10890147|NCT00515099|EG001|Reported Event|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
10890148|NCT00515177|BG000|Baseline|Randomized to MBSR|
10890149|NCT00515177|BG001|Baseline|Randomized to PCT|
10890150|NCT00515177|BG002|Baseline|Total|Total of all reporting groups
10890151|NCT00515177|FG000|Participant Flow|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
10890152|NCT00515177|FG001|Participant Flow|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
10890153|NCT00515177|OG000|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
10890154|NCT00515177|OG001|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
10890155|NCT00515177|OG001|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use."
10890156|NCT00515177|EG000|Reported Event|Pharmacotherapy (Eszopiclone, 3mg)|The PCT control treatment consisted of 3mg eszopiclone nightly for 8 weeks, followed by use as needed for 3 months.
10890157|NCT00515177|EG001|Reported Event|MBSR|Mindfulness-Based Stress Reduction (MBSR) is an 8 week program of yoga and mindfulness training taught by a trained instructor in a group format.
10890158|NCT00515203|BG000|Baseline|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
10890159|NCT00515203|BG001|Baseline|Placebo|Placebo by subcutaneous injection once weekly
10890160|NCT00515203|BG002|Baseline|Total|Total of all reporting groups
11335588|NCT03553758|OG000|Outcome|Ketamine|"15 subjects undergoing ketamine general anesthesia.~Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."
10890161|NCT00515203|FG000|Participant Flow|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
10890162|NCT00515203|FG001|Participant Flow|Placebo|Placebo by subcutaneous injection once weekly
10890163|NCT00515203|OG000|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
10890164|NCT00515203|OG001|Outcome|Placebo|Placebo by subcutaneous injection once weekly
10890165|NCT00515203|EG000|Reported Event|Placebo|
10890166|NCT00515203|EG001|Reported Event|Romiplostim|
10890167|NCT00515216|BG000|Baseline|Oxaliplatin/Leucovorin/5-FU|"Good risk patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks."
10890168|NCT00515216|FG000|Participant Flow|Oxaliplatin/Leucovorin/5-FU|"Good risk patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype~Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
10890169|NCT00515216|OG000|Outcome|Oxaliplatin/Leucovorin/5-FU|"Good risk patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks."
10890170|NCT00515216|OG000|Outcome|Oxaliplatin/Leucovorin/5-FU|"Good risk patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype~Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
10890171|NCT00515216|EG000|Reported Event|Oxaliplatin/Leucovorin/5-FU|"Good risk patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks."
10890172|NCT00515294|BG000|Baseline|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
10890173|NCT00515294|BG001|Baseline|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
10890174|NCT00515294|BG002|Baseline|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
10890175|NCT00515294|BG003|Baseline|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
10890176|NCT00515294|BG004|Baseline|Total|Total of all reporting groups
10890177|NCT00515294|FG000|Participant Flow|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
10890178|NCT00515294|FG001|Participant Flow|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
10890179|NCT00515294|FG002|Participant Flow|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
10890180|NCT00515294|FG003|Participant Flow|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
10890181|NCT00515294|OG000|Outcome|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
10890182|NCT00515294|OG001|Outcome|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
11090002|NCT01526551|OG000|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
11090003|NCT01526551|EG000|Reported Event|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
10890183|NCT00515294|OG002|Outcome|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
10890184|NCT00515294|OG003|Outcome|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
10890185|NCT00515294|EG000|Reported Event|1Caffeinated Alcohol|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
10890186|NCT00515294|EG001|Reported Event|2Non-Caffeinated Alcohol|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
10890187|NCT00515294|EG002|Reported Event|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
10890188|NCT00515294|EG003|Reported Event|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
10890189|NCT00515411|BG000|Baseline|Arm A, - Modified DCF|"Drug Dose (mg/m2) Schedule~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).~Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)"
10890190|NCT00515411|BG001|Baseline|ARM B - Parent DCF With G-CSF|"Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17 * 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg~Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17~* 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg~Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter."
10890191|NCT00515411|BG002|Baseline|Arm C - Modified DCF+ Trastuzumab|"Treatment for Her2 Positive Participants~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes."
10890192|NCT00515411|BG003|Baseline|Total|Total of all reporting groups
10890193|NCT00515411|FG000|Participant Flow|Arm A, - Modified DCF|"Drug Dose (mg/m2) Schedule~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).~Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)"
10914724|NCT00632619|OG001|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
11090004|NCT01526577|BG000|Baseline|Single Dosing LC23-1306|Experimental drug LC23-1306 10, 30, 100, 200, 400, 600 mg
11090005|NCT01526577|BG001|Baseline|Single Dosing Placebo|
11090006|NCT01526577|BG002|Baseline|Multiple Dosing LC23-1306|Experimental drug LC23-1306 100, 200, 400, 600mg
11090007|NCT01526577|BG003|Baseline|Multiple Dosing Placebo|
11090008|NCT01526577|BG004|Baseline|Multiple Dosing Ticagrelor 90mg|Active comparator
11090009|NCT01526577|BG005|Baseline|Total|Total of all reporting groups
11090010|NCT01526577|FG000|Participant Flow|Single Dosing LC23-1306|experimental drug LC23-1306 10, 30, 100, 200, 400, 600 mg
11090011|NCT01526577|FG001|Participant Flow|Single Dosing Placebo|
11090012|NCT01526577|FG002|Participant Flow|Multiple Dosing LC23-1306|LC23-1306 100, 200, 400, 600mg
11090013|NCT01526577|FG003|Participant Flow|Multiple Dosing Placebo|
11090014|NCT01526577|FG004|Participant Flow|Multiple Dosing Ticagrelor 90mg|Active comparator
11090015|NCT01526577|OG000|Outcome|LC23-1306|"experimental drug~LC23-1306: LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg"
11090016|NCT01526577|OG001|Outcome|Placebo|"LC23-1306 placebo~placebo: LC23-1306 placebo"
11090017|NCT01526577|OG002|Outcome|Ticagrelor|"active comparator~Ticagrelor: Ticagrelor 90mg"
11090018|NCT01526577|EG000|Reported Event|LC23-1306|Test drug.
11090019|NCT01526577|EG001|Reported Event|Ticagrelar|Active comparator
11090020|NCT01526577|EG002|Reported Event|Placebo|
11090021|NCT01526629|BG000|Baseline|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
11090022|NCT01526629|FG000|Participant Flow|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
11090023|NCT01526629|OG000|Outcome|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
11090024|NCT01526629|EG000|Reported Event|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
11090025|NCT01526733|BG000|Baseline|All Enrolled Participants|All participants enrolled in the study.
11090026|NCT01526733|FG000|Participant Flow|Insulin-rHuPH20, Then Insulin-sham|"In Phase I, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 milliliter (mL) (150 U) injection of recombinant human hyaluronidase PH20 (rHuPH20).~In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Phase I and II were separated by a washout period of 5 to 21 days."
11090027|NCT01526733|FG001|Participant Flow|Insulin-sham, Then Insulin-rHuPH20|"In Phase I, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injection administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Phase I and Phase II were separated by a washout period of 5 to 21 days."
11090028|NCT01526733|OG000|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
11090029|NCT01526733|OG001|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
11090030|NCT01526733|OG000|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
11090031|NCT01526733|EG000|Reported Event|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
11090032|NCT01526733|EG001|Reported Event|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
11090033|NCT01526785|BG000|Baseline|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
11090034|NCT01526785|FG000|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (4000 litre [L] scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice.
11090035|NCT01526785|OG000|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
11090036|NCT01526785|EG000|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per participant's routine practice.
11090037|NCT01526889|BG000|Baseline|LFG316|LFG316 administered intravitreally
11090038|NCT01526889|BG001|Baseline|Conventional Therapy|Conventional treatment was selected by the investigator
11090039|NCT01526889|BG002|Baseline|Total|Total of all reporting groups
11090040|NCT01526889|FG000|Participant Flow|LFG316|LFG316 administered intravitreally
10890194|NCT00515411|FG001|Participant Flow|ARM B - Parent DCF With G-CSF|"Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17 * 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg~Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17~* 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg~Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter."
10890195|NCT00515411|FG002|Participant Flow|Arm C - Modified DCF+ Trastuzumab|"Treatment for Her2 Positive Participants~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes."
10890196|NCT00515411|OG000|Outcome|Arm A, - Modified DCF|"Drug Dose (mg/m2) Schedule~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).~Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)"
10890197|NCT00515411|OG001|Outcome|ARM B - Parent DCF With G-CSF|"Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17 * 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg~Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17~* 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg~Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter."
10890198|NCT00515411|OG002|Outcome|Arm C - Modified DCF+ Trastuzumab|"Treatment for Her2 Positive Participants~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes."
10890199|NCT00515411|EG000|Reported Event|Arm A, - Modified DCF|"Drug Dose (mg/m2) Schedule~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).~Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)"
10890200|NCT00515411|EG001|Reported Event|ARM B - Parent DCF With G-CSF|"Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17 * 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg~Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17~* 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg~Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter."
10890201|NCT00515411|EG002|Reported Event|Arm C - Modified DCF+ Trastuzumab|"Treatment for Her2 Positive Participants~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes."
10890202|NCT00515437|BG000|Baseline|1500U Myobloc|1500U Myobloc
10890203|NCT00515437|BG001|Baseline|2500U Myobloc|2500U Myobloc
10890204|NCT00515437|BG002|Baseline|3500U Myobloc|3500U Myobloc
10890205|NCT00515437|BG003|Baseline|Placebo|Placebo
10890206|NCT00515437|BG004|Baseline|Total|Total of all reporting groups
10890207|NCT00515437|FG000|Participant Flow|1500U Myobloc|1500U Myobloc
10890208|NCT00515437|FG001|Participant Flow|2500U Myobloc|2500U Myobloc
10890209|NCT00515437|FG002|Participant Flow|3500U Myobloc|3500U Myobloc
11090041|NCT01526889|FG001|Participant Flow|Conventional Therapy|Conventional treatment was selected by the investigator
10890210|NCT00515437|FG003|Participant Flow|Placebo|Placebo
10890211|NCT00515437|OG000|Outcome|1500U Myobloc|1500U Myobloc
10890212|NCT00515437|OG001|Outcome|2500U Myobloc|2500U Myobloc
10890213|NCT00515437|OG002|Outcome|3500U Myobloc|3500U Myobloc
10890214|NCT00515437|OG003|Outcome|Placebo|Placebo
10890215|NCT00515437|EG000|Reported Event|1500U Myobloc|1500U Myobloc
10890216|NCT00515437|EG001|Reported Event|2500U Myobloc|2500U Myobloc
10890217|NCT00515437|EG002|Reported Event|3500U Myobloc|3500U Myobloc
10890218|NCT00515437|EG003|Reported Event|Placebo|Placebo
10890219|NCT00515463|BG000|Baseline|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
10890220|NCT00515463|BG001|Baseline|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
10890221|NCT00515463|BG002|Baseline|Total|Total of all reporting groups
11090042|NCT01526889|OG000|Outcome|LFG316|LFG316 administered intravitreally
11090043|NCT01526889|OG001|Outcome|Conventional Therapy|Conventional treatment was selected by the investigator
11090044|NCT01526889|EG000|Reported Event|LFG316|LF G316 administered intravitreally
11090045|NCT01526889|EG001|Reported Event|Conventional Therapy|Conventional treatment was selected by the investigator
11090046|NCT01526902|BG000|Baseline|Overall Study Population|Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
11090047|NCT01526902|FG000|Participant Flow|Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
11090048|NCT01526902|FG001|Participant Flow|Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
11090049|NCT01526902|OG000|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
11090050|NCT01526902|OG001|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
11090051|NCT01526902|EG000|Reported Event|Omafilcon A / PC1DMF L2A (TEST)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
10890222|NCT00515463|FG000|Participant Flow|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
10890223|NCT00515463|FG001|Participant Flow|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
10890224|NCT00515463|OG000|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
10890225|NCT00515463|OG001|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe (PFS) on Day 1 and at Month 6.
10890226|NCT00515463|OG001|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
10890227|NCT00515463|EG000|Reported Event|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
10890228|NCT00515463|EG001|Reported Event|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
10890229|NCT00515502|BG000|Baseline|All Study Treatments|Participants received a sequence containing 4 of the following 5 possible treatments: placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and Tiotropium 18 µg. Participants received each of the treatments in 1 of 4 single dose treatment periods, each of which was followed by a washout period. Treatment periods 1, 2, and 3 were followed by at least a 14-day washout period; Treatment period 4 was followed by a Follow-up visit within 10 days.
10890230|NCT00515502|FG000|Participant Flow|Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: umeclidinium bromide (UMEC) 250 micrograms (µg), UMEC 500 µg, Tiotropium 18 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
10890231|NCT00515502|FG001|Participant Flow|Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
10890232|NCT00515502|FG002|Participant Flow|Seq 3: UMEC 250 µg, Placebo, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
10890233|NCT00515502|FG003|Participant Flow|Seq 4: UMEC 250 µg, UMEC 500 µg, Placebo, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, placebo and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
10890234|NCT00515502|FG004|Participant Flow|Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
10890235|NCT00515502|FG005|Participant Flow|Seq 6: UMEC 250 µg, Placebo, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
11090052|NCT01526902|EG001|Reported Event|Lotrafilcon B / Air Optix MF (CONTROL)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
11090053|NCT01526928|BG000|Baseline|Rociletinib <900 mg BID FB Capsules|Rociletinib free base (FB) dose <900 mg twice a day (BID).
11090054|NCT01526928|BG001|Baseline|Rociletinib 900 mg BID FB Capsules|Rociletinib free base (FB) dose 900 mg twice a day (BID).
11090055|NCT01526928|BG002|Baseline|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
11090056|NCT01526928|BG003|Baseline|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
10890236|NCT00515502|FG006|Participant Flow|Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, Tiotropium 18 µg, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
10890237|NCT00515502|FG007|Participant Flow|Seq 8: Tiotropium 18 µg, Placebo, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, placebo, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
10890238|NCT00515502|FG008|Participant Flow|Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
10890239|NCT00515502|FG009|Participant Flow|Seq 10: Tiotropium 18 µg, UMEC 250 µg, Placebo, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, placebo and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
10890240|NCT00515502|FG010|Participant Flow|Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
10890241|NCT00515502|FG011|Participant Flow|Seq 12: UMEC 250 µg, Placebo, UMEC 500 µg, Tiotropium 18 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and Tiotropium 18 µg. Treatment periods were seperated by a washout period of at least 14 days.
10890242|NCT00515502|OG000|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890243|NCT00515502|OG001|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 micrograms (µg) via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
11090057|NCT01526928|BG004|Baseline|Rociletinib 750 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
11090058|NCT01526928|BG005|Baseline|Rociletinib 1000 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
11233181|NCT02424630|FG001|Participant Flow|ISB Alone|"During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.~Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL."
11233182|NCT02424630|OG000|Outcome|ISB With SSNB|During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
11233183|NCT02424630|OG001|Outcome|ISB Alone|During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
11233184|NCT02424630|EG000|Reported Event|ISB With SSNB|"During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.~Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.~Arthroscopy-guided SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist."
11233185|NCT02424630|EG001|Reported Event|ISB Alone|"During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.~Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL."
11233186|NCT02424734|BG000|Baseline|Ceftaroline Fosamil: Young Infants|Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
11090059|NCT01526928|BG006|Baseline|Total|Total of all reporting groups
10890244|NCT00515502|OG002|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890245|NCT00515502|OG003|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890246|NCT00515502|OG004|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890247|NCT00515502|OG001|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890248|NCT00515502|OG000|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890249|NCT00515502|OG001|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890250|NCT00515502|OG002|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890251|NCT00515502|OG000|Outcome|UMEC 250 µg|
10890252|NCT00515502|EG000|Reported Event|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890253|NCT00515502|EG001|Reported Event|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890254|NCT00515502|EG002|Reported Event|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890255|NCT00515502|EG003|Reported Event|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890256|NCT00515502|EG004|Reported Event|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
10890257|NCT00515528|BG000|Baseline|Vaccine Alone|Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
10890258|NCT00515528|BG001|Baseline|Vaccine Plus Ontak|Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
10890259|NCT00515528|BG002|Baseline|Total|Total of all reporting groups
10890260|NCT00515528|FG000|Participant Flow|Vaccine Alone|Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
10890261|NCT00515528|FG001|Participant Flow|Vaccine Plus Ontak|Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
10890262|NCT00515528|OG000|Outcome|Vaccine Alone|Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
10890263|NCT00515528|OG001|Outcome|Vaccine Plus Ontak|Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
10890264|NCT00515528|EG000|Reported Event|Vaccine Alone|Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
10890265|NCT00515528|EG001|Reported Event|Vaccine Plus Ontak|Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
10890266|NCT00515541|BG000|Baseline|Group A: Subject on Lovaza Only|Group A: Subject is not on Aspirin, Clopidogrel, or Warfarin. Subject is taking escalating doses of study drug (Lovaza)over a 24 week period.
10890267|NCT00515541|BG001|Baseline|Group. B: Subject on Lovaza + Aspirin|Group B: Subject on Aspirin (< or = 325mg and is not taking Clopidogrel or Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
10890268|NCT00515541|BG002|Baseline|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject is taking Clopidogrel 75mg)and Aspirin (< or = 325mg) and not taking Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
10890269|NCT00515541|BG003|Baseline|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject is taking Warfarin and Aspirin (< or = 325mg)and is not taking Clopidogrel. Subject is taking escalating doses of Lovaza over a 24 week period.
10890270|NCT00515541|BG004|Baseline|Total|Total of all reporting groups
10890271|NCT00515541|FG000|Participant Flow|Group A: Subjects on Lovaza Only|Group A: Subject is healthly and not on Aspirin, Clopidogrel, or Warfarin. Subjects will be taking escalating doses of the study drug (Lovaza)up to 24 weeks.
10890272|NCT00515541|FG001|Participant Flow|Group B: Subjects on Lovaza Plus Aspirin|Group B: Subject is only taking Aspirin (< or = 325mg) daily. Subjects will be taking escalating doses of study drug (Lovaza) in addition to aspirin up to 24 weeks.
10890273|NCT00515541|FG002|Participant Flow|Group C: Subjects on Lovaza Plus Clopidogrel and Aspirin|Subject is regularly taking Clopidogrel (75mg)and Aspirin (< or = 325mg)daily, and not taking Warfarin. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Clopidogrel and Aspirin up to 24 weeks.
10890274|NCT00515541|FG003|Participant Flow|Group D: Subjects on Lovaza Plus Warfarin and Aspirin|Subject is regularly taking Warfarin and Aspirin (< or = 325mg)daily, and not taking Clopidogrel. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Warfarin and Aspirin up to 24 weeks.
10890275|NCT00515541|OG000|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
10890276|NCT00515541|OG001|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
10890277|NCT00515541|OG002|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
10890278|NCT00515541|OG003|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
10890279|NCT00515541|EG000|Reported Event|Group A|Lovaza only
10890280|NCT00515541|EG001|Reported Event|Group B|Lovaza plus aspirin
10890281|NCT00515541|EG002|Reported Event|Group C|Lovaza plus clopidogrel
10890282|NCT00515541|EG003|Reported Event|Group D|Lovaza plus aspirin plus coumadin
10890283|NCT00515619|BG000|Baseline|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
10890284|NCT00515619|FG000|Participant Flow|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
10890285|NCT00515619|OG000|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
10890286|NCT00515619|EG000|Reported Event|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
10890287|NCT00515697|BG000|Baseline|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
10890288|NCT00515697|FG000|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
10890289|NCT00515697|OG000|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
10890290|NCT00515697|EG000|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
10890291|NCT00515723|BG000|Baseline|Olanzapine|Participants with schizophrenia were randomized to olanzapine.
10890292|NCT00515723|BG001|Baseline|Risperidone|Patients with schizophrenia were randomized to risperidone.
11335589|NCT03553758|EG000|Reported Event|Ketamine|"15 subjects undergoing ketamine general anesthesia.~Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."
10890293|NCT00515723|BG002|Baseline|Quetiapine|Participants with schizophrenia were randomized to quetiapine.
10890294|NCT00515723|BG003|Baseline|Ziprasidone|Participants with schizophrenia were randomized to ziprasidone.
10890295|NCT00515723|BG004|Baseline|Total|Total of all reporting groups
10890296|NCT00515723|FG000|Participant Flow|Olanzapine|Participants in this group were randomized to flexibly-dosed treatment with olanzapine.
10890297|NCT00515723|FG001|Participant Flow|Risperidone|Participants in this group were randomized to flexibly-dosed treatment with risperidone.
10890298|NCT00515723|FG002|Participant Flow|Quetiapine|Participants in this group were randomized to flexibly-dosed treatment with quetiapine.
10890299|NCT00515723|FG003|Participant Flow|Ziprasidone|Participants in this group were randomized to flexibly-dosed treatment with ziprasidone.
10890300|NCT00515723|OG000|Outcome|Olanzapine|Participants in this group were randomized to flexibly-dosed treatment with olanzapine.
10890301|NCT00515723|OG001|Outcome|Risperidone|Participants in this group were randomized to flexibly-dosed treatment with risperidone.
10890302|NCT00515723|OG002|Outcome|Quetiapine|Participants in this group were randomized to flexibly-dosed treatment with quetiapine.
10890303|NCT00515723|OG003|Outcome|Ziprasidone|Participants in this group were randomized to flexibly-dosed treatment with ziprasidone.
10890304|NCT00515723|OG004|Outcome|Total|This arm consists of all treatments pooled together.
10890305|NCT00515723|EG000|Reported Event|Olanzapine|Participants with schizophrenia were randomized to olanzapine.
10890306|NCT00515723|EG001|Reported Event|Risperidone|Patients with schizophrenia were randomized to risperidone.
10890307|NCT00515723|EG002|Reported Event|Quetiapine|Participants with schizophrenia were randomized to quetiapine.
10890308|NCT00515723|EG003|Reported Event|Ziprasidone|Participants with schizophrenia were randomized to ziprasidone.
10890309|NCT00515827|BG000|Baseline|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
10890310|NCT00515827|BG001|Baseline|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
10890311|NCT00515827|BG002|Baseline|Total|Total of all reporting groups
10890312|NCT00515827|FG000|Participant Flow|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
10890313|NCT00515827|FG001|Participant Flow|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
10890314|NCT00515827|OG000|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
10890315|NCT00515827|OG001|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
10890316|NCT00515827|OG000|Outcome|Placebo (Arm A)|Placebo administered twice daily in addition to optimized background regimen (OBR) from week 12 to week 24
10890317|NCT00515827|OG001|Outcome|Raltegravir (Arm B)|400 mg raltegravir (MK-0518) administered twice daily in addition to OBR from week 12 to week 24
10890318|NCT00515827|EG000|Reported Event|Raltegravir|Baseline to Week 12 for Arm A (Raltegravir then Placebo), and Week 12 to Week 24 for Arm B (Placebo then Raltegravir).
10890319|NCT00515827|EG001|Reported Event|Placebo|Week 12 to Week 24 for Arm A (Raltegravir then Placebo), and Baseline to Week 12 for Arm B (Placebo then Raltegravir).
10890320|NCT00515879|BG000|Baseline|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
10890321|NCT00515879|BG001|Baseline|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
11335590|NCT03553823|BG000|Baseline|Secukinumab|20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
10890322|NCT00515879|BG002|Baseline|Total|Total of all reporting groups
10890323|NCT00515879|FG000|Participant Flow|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
10890324|NCT00515879|FG001|Participant Flow|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
10890325|NCT00515879|OG000|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
10890326|NCT00515879|OG001|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
10890327|NCT00515879|OG000|Outcome|CBT Plus D-cycloserine|"Participants will receive cognitive behavioral therapy plus D-cycloserine~D-cycloserine: 50 mg~Cognitive behavioral therapy (CBT): CBT sessions aim to help participants become more comfortable with social situations."
10890328|NCT00515879|OG001|Outcome|CBT Plus Placebo|"Participants will receive cognitive behavioral therapy plus pill placebo~Cognitive behavioral therapy (CBT): CBT sessions aim to help participants become more comfortable with social situations.~Placebo: Same dosage as active pill"
10890329|NCT00515879|EG000|Reported Event|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
10890330|NCT00515879|EG001|Reported Event|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
10890331|NCT00516048|BG000|Baseline|Negative Baseline (Week 0) Antibody Status|Patients assessed as negative for antibodies to exenatide at baseline (Week 0).
10890332|NCT00516048|BG001|Baseline|Positive Baseline (Week 0) Antibody Status|Patients assessed as positive for antibodies to exenatide at baseline (Week 0).
10890333|NCT00516048|BG002|Baseline|Total|Total of all reporting groups
10890334|NCT00516048|FG000|Participant Flow|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
10890335|NCT00516048|FG001|Participant Flow|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
10890336|NCT00516048|FG002|Participant Flow|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
10890337|NCT00516048|OG000|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
10890338|NCT00516048|OG001|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
10890339|NCT00516048|OG002|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
10890340|NCT00516048|EG000|Reported Event|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
10890341|NCT00516048|EG001|Reported Event|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
10890342|NCT00516048|EG002|Reported Event|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
10890343|NCT00516074|BG000|Baseline|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
10890344|NCT00516074|BG001|Baseline|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
10890345|NCT00516074|BG002|Baseline|Total|Total of all reporting groups
10890346|NCT00516074|FG000|Participant Flow|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
10890347|NCT00516074|FG001|Participant Flow|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
10890348|NCT00516074|OG000|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
10890349|NCT00516074|OG001|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
10890350|NCT00516074|EG000|Reported Event|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
10890351|NCT00516074|EG001|Reported Event|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
10890352|NCT00516139|BG000|Baseline|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
10890353|NCT00516139|FG000|Participant Flow|Lamotrigine (LTG)-Extended Release (XR) Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
10890354|NCT00516139|OG000|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
10890355|NCT00516139|OG000|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
10890356|NCT00516139|OG001|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
10890357|NCT00516139|OG002|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
11335591|NCT03553823|BG001|Baseline|Guselkumab|20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
11335592|NCT03553823|BG002|Baseline|Total|Total of all reporting groups
10890358|NCT00516139|OG000|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
10890359|NCT00516139|EG000|Reported Event|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
10890360|NCT00516165|BG000|Baseline|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
11171016|NCT01999946|BG002|Baseline|Methadone Treatment Program (MTP)|Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
11171017|NCT01999946|BG003|Baseline|Total|Total of all reporting groups
11171018|NCT01999946|FG000|Participant Flow|Extended-Release Naltrexone (XR-NTX)|"Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection."
11171019|NCT01999946|FG001|Participant Flow|Enhanced Treatment As Usual (ETAU)|Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
10890361|NCT00516165|FG000|Participant Flow|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
10890362|NCT00516165|OG000|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
10890363|NCT00516165|EG000|Reported Event|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
10890364|NCT00516217|BG000|Baseline|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
11171020|NCT01999946|FG002|Participant Flow|Methadone Treatment Program (MTP)|Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
11171021|NCT01999946|OG000|Outcome|Extended-Release Naltrexone (XR-NTX)|"Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection."
10890365|NCT00516217|FG000|Participant Flow|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
10890366|NCT00516217|OG000|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
10890367|NCT00516217|EG000|Reported Event|Galaximab|Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
10890368|NCT00516269|BG000|Baseline|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks~Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
10890369|NCT00516269|BG001|Baseline|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
10890370|NCT00516269|BG002|Baseline|Total|Total of all reporting groups
10890371|NCT00516269|FG000|Participant Flow|Methylphenidate Then Placebo|Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks
10890372|NCT00516269|FG001|Participant Flow|Placebo Then Methylphenidate|Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks
10890373|NCT00516269|OG000|Outcome|Methylphenidate|Methylphenidate 18 mg oral daily for 2 Weeks preceded or followed by Placebo oral daily for 2 weeks.
10890374|NCT00516269|OG001|Outcome|Placebo|Placebo taken oral daily for 2 Weeks.
10890375|NCT00516269|EG000|Reported Event|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks~Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
10890376|NCT00516269|EG001|Reported Event|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
10890377|NCT00516295|BG000|Baseline|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
11335593|NCT03553823|FG000|Participant Flow|Secukinumab|20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
10890378|NCT00516295|BG001|Baseline|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I
10890379|NCT00516295|BG002|Baseline|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
10890380|NCT00516295|BG003|Baseline|Total|Total of all reporting groups
10890381|NCT00516295|FG000|Participant Flow|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
10890382|NCT00516295|FG001|Participant Flow|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
10890383|NCT00516295|FG002|Participant Flow|Arm III (CTC)|Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.
10890384|NCT00516295|OG000|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
10890385|NCT00516295|OG001|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
10890386|NCT00516295|OG002|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
10890387|NCT00516295|EG000|Reported Event|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
10890388|NCT00516295|EG001|Reported Event|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
10890389|NCT00516295|EG002|Reported Event|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
10890390|NCT00516321|BG000|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10890391|NCT00516321|BG001|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10890392|NCT00516321|BG002|Baseline|Total|Total of all reporting groups
10890393|NCT00516321|FG000|Participant Flow|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
10890394|NCT00516321|FG001|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10890395|NCT00516321|FG002|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10890396|NCT00516321|OG000|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
11171022|NCT01999946|OG001|Outcome|Enhanced Treatment As Usual (ETAU)|Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
11171023|NCT01999946|EG000|Reported Event|Extended-Release Naltrexone (XR-NTX)|"Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection."
11171024|NCT01999946|EG001|Reported Event|Enhanced Treatment As Usual (ETAU)|Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
11171025|NCT01999946|EG002|Reported Event|Methadone Treatment Program (MTP)|Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
11171026|NCT01999972|BG000|Baseline|Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg|Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171027|NCT01999972|BG001|Baseline|Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg|Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171028|NCT01999972|BG002|Baseline|Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg|Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171029|NCT01999972|BG003|Baseline|Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg|Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171030|NCT01999972|BG004|Baseline|Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11335594|NCT03553823|FG001|Participant Flow|Guselkumab|20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
10890397|NCT00516321|OG001|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10890398|NCT00516321|OG000|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
10890399|NCT00516321|EG000|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
10890400|NCT00516321|EG001|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10890401|NCT00516321|EG002|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10890402|NCT00516386|BG000|Baseline|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
10890403|NCT00516386|FG000|Participant Flow|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
10890404|NCT00516386|OG000|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
10890405|NCT00516386|EG000|Reported Event|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
10890406|NCT00516503|BG000|Baseline|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
10890407|NCT00516503|BG001|Baseline|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
10890408|NCT00516503|BG002|Baseline|Total|Total of all reporting groups
10890409|NCT00516503|FG000|Participant Flow|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
10890410|NCT00516503|FG001|Participant Flow|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
10890411|NCT00516503|OG000|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
10890412|NCT00516503|OG001|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
10890413|NCT00516503|EG000|Reported Event|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
10890414|NCT00516503|EG001|Reported Event|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
10890415|NCT00516893|BG000|Baseline|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
10890416|NCT00516893|FG000|Participant Flow|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
10890417|NCT00516893|OG000|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
10890418|NCT00516893|EG000|Reported Event|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
10890419|NCT00516906|BG000|Baseline|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
10890420|NCT00516906|BG001|Baseline|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
10890421|NCT00516906|BG002|Baseline|Total|Total of all reporting groups
10890422|NCT00516906|FG000|Participant Flow|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
10890423|NCT00516906|FG001|Participant Flow|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
10890424|NCT00516906|OG000|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
10890425|NCT00516906|OG001|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
10890426|NCT00516906|EG000|Reported Event|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
10890427|NCT00516906|EG001|Reported Event|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
10890428|NCT00516919|BG000|Baseline|Total Enrollment|
10890429|NCT00516919|FG000|Participant Flow|Xenical + Behavioral Intervention|"Drug: Xenical + Behavioral: behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
10890430|NCT00516919|FG001|Participant Flow|Placebo + Behavioral Intervention|"Drug: Placebo + Behavioral: behavioral intervention~Behavioral intervention + placebo : Behavioral weight loss treatment in Spanish Placebo three times a day"
10890431|NCT00516919|OG000|Outcome|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
10890432|NCT00516919|OG001|Outcome|Drug: Placebo + Behavioral: Behavioral Intervention|"Placebo + behavioral intervention~Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
10890433|NCT00516919|EG000|Reported Event|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
10890434|NCT00516919|EG001|Reported Event|Drug: Placebo + Behaviora: Behavioral Intervention|"Placebo + behavioral intervention~Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
10890435|NCT00517010|BG000|Baseline|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
10890436|NCT00517010|FG000|Participant Flow|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
10890437|NCT00517010|OG000|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
10890438|NCT00517010|EG000|Reported Event|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
10890439|NCT00517296|BG000|Baseline|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
10890440|NCT00517296|BG001|Baseline|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
10890441|NCT00517296|BG002|Baseline|Total|Total of all reporting groups
10890442|NCT00517296|FG000|Participant Flow|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
10890443|NCT00517296|FG001|Participant Flow|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
10890444|NCT00517296|OG000|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
10890445|NCT00517296|OG001|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
10890446|NCT00517296|EG000|Reported Event|A, Combination Therapy Group|"Group A patients will be randomized to TNF and seton placement.~Seton placement: Patients randomized to the combination therapy group will have seton placement prior to initiating therapy with Certolizumab."
11335595|NCT03553823|OG000|Outcome|Secukinumab|20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
10890447|NCT00517296|EG001|Reported Event|B, Control Arm|Group B patients will be randomized to surgical guidance / standard of care
10890448|NCT00517413|BG000|Baseline|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
10890449|NCT00517413|FG000|Participant Flow|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta [Mircera]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
10890450|NCT00517413|OG000|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
10890451|NCT00517413|EG000|Reported Event|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
10890452|NCT00517530|BG000|Baseline|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
10890453|NCT00517530|BG001|Baseline|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
10890454|NCT00517530|BG002|Baseline|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
10890455|NCT00517530|BG003|Baseline|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
10890456|NCT00517530|BG004|Baseline|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
10890457|NCT00517530|BG005|Baseline|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
10890458|NCT00517530|BG006|Baseline|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
10890459|NCT00517530|BG007|Baseline|Total|Total of all reporting groups
10890460|NCT00517530|FG000|Participant Flow|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
10890461|NCT00517530|FG001|Participant Flow|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
10890462|NCT00517530|FG002|Participant Flow|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
10890463|NCT00517530|FG003|Participant Flow|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
10890464|NCT00517530|FG004|Participant Flow|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
10890465|NCT00517530|FG005|Participant Flow|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
10890466|NCT00517530|FG006|Participant Flow|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
10890467|NCT00517530|OG000|Outcome|50/100 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890468|NCT00517530|OG001|Outcome|100/200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890469|NCT00517530|OG002|Outcome|200/400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890470|NCT00517530|OG003|Outcome|400/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890471|NCT00517530|OG004|Outcome|800/1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890472|NCT00517530|OG005|Outcome|1200/2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890473|NCT00517530|OG006|Outcome|1600/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
11171031|NCT01999972|BG005|Baseline|Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
10890474|NCT00517530|OG007|Outcome|400/800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
10890475|NCT00517530|OG008|Outcome|800/1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
10890476|NCT00517530|OG009|Outcome|1200/2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
10890477|NCT00517530|OG010|Outcome|1000/1000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
10890478|NCT00517530|OG000|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
10890479|NCT00517530|OG001|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
10890480|NCT00517530|OG002|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
10890481|NCT00517530|OG003|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
10890482|NCT00517530|OG004|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
10890483|NCT00517530|OG000|Outcome|Phase II, iNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
10890484|NCT00517530|OG001|Outcome|Phase II, aNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
10890485|NCT00517530|OG002|Outcome|Phase II, CLL|Obinutuzumab intravenous infusion at 1000/1000 mg
10890486|NCT00517530|OG000|Outcome|Retreated Participants|Obinutuzumab intravenous infusion
10890487|NCT00517530|OG000|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890488|NCT00517530|OG001|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890489|NCT00517530|OG002|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
11171032|NCT01999972|BG006|Baseline|Total|Total of all reporting groups
10890490|NCT00517530|OG003|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
10890491|NCT00517530|OG000|Outcome|400 mg - Phase I, CLL|Obinutuzumab intravenous infusion
10890492|NCT00517530|OG001|Outcome|800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
10890493|NCT00517530|OG002|Outcome|1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
10890494|NCT00517530|OG003|Outcome|2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
10890495|NCT00517530|EG000|Reported Event|Safety Population|Safety-Evaluable Participants
10890496|NCT00517556|BG000|Baseline|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
10890497|NCT00517556|BG001|Baseline|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
10890498|NCT00517556|BG002|Baseline|Total|Total of all reporting groups
10890499|NCT00517556|FG000|Participant Flow|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
10890500|NCT00517556|FG001|Participant Flow|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
10890501|NCT00517556|OG000|Outcome|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
10890502|NCT00517556|OG001|Outcome|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
10890503|NCT00517556|EG000|Reported Event|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
10890504|NCT00517556|EG001|Reported Event|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
10890505|NCT00517595|BG000|Baseline|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
10890506|NCT00517595|FG000|Participant Flow|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
10890507|NCT00517595|OG000|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
10890508|NCT00517595|EG000|Reported Event|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
10890509|NCT00517634|BG000|Baseline|Overall Study Population|Overall Study Population: participants in all three treatment periods
10890510|NCT00517634|FG000|Participant Flow|Sequence 1: FP, SFC, Placebo|Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
10890511|NCT00517634|FG001|Participant Flow|Sequence 2: Placebo, SFC, FP|Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
10890512|NCT00517634|FG002|Participant Flow|Sequence 3: SFC, FP, Placebo|Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
10890513|NCT00517634|FG003|Participant Flow|Sequence 4: SFC, Placebo, FP|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
10890514|NCT00517634|FG004|Participant Flow|Sequence 5: FP, Placebo, SFC|Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
10890515|NCT00517634|FG005|Participant Flow|Sequence 6: Placebo, FP, SFC|Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
10890516|NCT00517634|OG000|Outcome|Placebo|Placebo
10890517|NCT00517634|OG001|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
10890518|NCT00517634|OG002|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
10890519|NCT00517634|EG000|Reported Event|Placebo|Placebo
10890520|NCT00517634|EG001|Reported Event|FP 100 mcg BID|Fluticasone Propionate 100 mcg BID
10890521|NCT00517634|EG002|Reported Event|SFC 50/100 BID|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID
11171033|NCT01999972|FG000|Participant Flow|Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg|Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171034|NCT01999972|FG001|Participant Flow|Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg|Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
10890522|NCT00517751|BG000|Baseline|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
10890523|NCT00517751|FG000|Participant Flow|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
10890524|NCT00517751|OG000|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
10890525|NCT00517751|EG000|Reported Event|X-STOP PEEK|In this arm, patients will undergo X-STOP PEEK surgery.
10890526|NCT00517829|BG000|Baseline|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
10890527|NCT00517829|BG001|Baseline|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
10890528|NCT00517829|BG002|Baseline|Total|Total of all reporting groups
10890529|NCT00517829|FG000|Participant Flow|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
10890530|NCT00517829|FG001|Participant Flow|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
10890531|NCT00517829|OG000|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
10890532|NCT00517829|OG001|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
10890533|NCT00517829|EG000|Reported Event|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
10890534|NCT00517829|EG001|Reported Event|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
10890535|NCT00517881|BG000|Baseline|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant's blood hemoglobin levels.
10890536|NCT00517881|FG000|Participant Flow|C.E.R.A.|Participants received subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms (mcg) every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant's blood hemoglobin levels.
10890537|NCT00517881|OG000|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant's blood hemoglobin levels.
10890538|NCT00517881|EG000|Reported Event|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant's blood hemoglobin levels.
10890539|NCT00517933|BG000|Baseline|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
10890540|NCT00517933|BG001|Baseline|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
10890541|NCT00517933|BG002|Baseline|Total|Total of all reporting groups
10890542|NCT00517933|FG000|Participant Flow|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
10890543|NCT00517933|FG001|Participant Flow|Placebo / Sildenafil|20 mg oral placebo 3 times per day
10890544|NCT00517933|OG000|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
10890545|NCT00517933|OG001|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
10890546|NCT00517933|OG000|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
10890547|NCT00517933|OG001|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
10890548|NCT00517933|OG000|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
10890549|NCT00517933|EG000|Reported Event|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
10890550|NCT00517933|EG001|Reported Event|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
10890551|NCT00518011|BG000|Baseline|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
10890552|NCT00518011|BG001|Baseline|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
10890553|NCT00518011|BG002|Baseline|Total|Total of all reporting groups
10890554|NCT00518011|FG000|Participant Flow|Gemcitabine|Participants received Gemcitabine 1000 milligram per meter square (mg/m^2)/day, intravenously (IV) on Days 1, 8, 15 and every 4 weeks for 6 cycles
10890555|NCT00518011|FG001|Participant Flow|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
10890556|NCT00518011|OG000|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
10890557|NCT00518011|OG001|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
10890558|NCT00518011|OG000|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
11090060|NCT01526928|FG000|Participant Flow|Rociletinib <900 mg BID FB Capsules|Rociletinib free base (FB) dose <900 mg twice a day (BID). FB doses tested ranged from 150 mg once a day (QD) up to 900 mg twice a day (BID). This arm also includes a 400 mg three times a day (TID) dose. Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
11171035|NCT01999972|FG002|Participant Flow|Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg|Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11335596|NCT03553823|OG001|Outcome|Guselkumab|20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
10890559|NCT00518011|EG000|Reported Event|Gemcitabine|Participants received Gemcitabine (1000 mg/m^2/day), IV on Days 1, 8, 15 of each 4 week cycle for 6 cycles
10890560|NCT00518011|EG001|Reported Event|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
10890561|NCT00518089|BG000|Baseline|Gatifloxacin 0.5% Eye Drops|
10890562|NCT00518089|BG001|Baseline|Placebo Eye Drops|
10890563|NCT00518089|BG002|Baseline|Total|Total of all reporting groups
10890564|NCT00518089|FG000|Participant Flow|Gatifloxacin 0.5% Eye Drops|
10890565|NCT00518089|FG001|Participant Flow|Placebo Eye Drops|
10890566|NCT00518089|OG000|Outcome|Gatifloxacin 0.5% Eye Drops|
10890567|NCT00518089|OG001|Outcome|Placebo Eye Drops|
10890568|NCT00518089|EG000|Reported Event|Gatifloxacin 0.5% Eye Drops|
10890569|NCT00518089|EG001|Reported Event|Placebo Eye Drops|
10890570|NCT00518115|BG000|Baseline|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890571|NCT00518115|BG001|Baseline|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
10890572|NCT00518115|BG002|Baseline|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890573|NCT00518115|BG003|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890574|NCT00518115|BG004|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890575|NCT00518115|BG005|Baseline|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890576|NCT00518115|BG006|Baseline|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890577|NCT00518115|BG007|Baseline|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890578|NCT00518115|BG008|Baseline|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890579|NCT00518115|BG009|Baseline|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890580|NCT00518115|BG010|Baseline|Total|Total of all reporting groups
10890581|NCT00518115|FG000|Participant Flow|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890582|NCT00518115|FG001|Participant Flow|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
10890583|NCT00518115|FG002|Participant Flow|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890584|NCT00518115|FG003|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890585|NCT00518115|FG004|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890586|NCT00518115|FG005|Participant Flow|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890587|NCT00518115|FG006|Participant Flow|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890588|NCT00518115|FG007|Participant Flow|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890589|NCT00518115|FG008|Participant Flow|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890590|NCT00518115|FG009|Participant Flow|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890591|NCT00518115|OG000|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890592|NCT00518115|OG001|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
10890593|NCT00518115|OG002|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890594|NCT00518115|OG003|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890595|NCT00518115|OG004|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890596|NCT00518115|OG005|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
11335597|NCT03553823|EG000|Reported Event|Secukinumab|Secukinumab
10890597|NCT00518115|OG006|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890598|NCT00518115|OG007|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890599|NCT00518115|OG008|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890600|NCT00518115|OG009|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890601|NCT00518115|OG000|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
10890602|NCT00518115|EG000|Reported Event|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
11335598|NCT03553823|EG001|Reported Event|Guselkumab|Guselkumab
11171036|NCT01999972|FG003|Participant Flow|Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg|Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171037|NCT01999972|FG004|Participant Flow|Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171038|NCT01999972|FG005|Participant Flow|Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171039|NCT01999972|OG000|Outcome|Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg|Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171040|NCT01999972|OG001|Outcome|Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg|Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171041|NCT01999972|OG002|Outcome|Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg|Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171042|NCT01999972|OG003|Outcome|Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg|Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171043|NCT01999972|OG004|Outcome|Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171044|NCT01999972|OG005|Outcome|Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171045|NCT01999972|OG000|Outcome|Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171046|NCT01999972|OG001|Outcome|Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171047|NCT01999972|EG000|Reported Event|Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg|Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171048|NCT01999972|EG001|Reported Event|Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg|Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171049|NCT01999972|EG002|Reported Event|Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg|Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171050|NCT01999972|EG003|Reported Event|Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg|Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11171051|NCT01999972|EG004|Reported Event|Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
11335599|NCT03553940|BG000|Baseline|M2SR|A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
10890603|NCT00518115|EG001|Reported Event|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
10890604|NCT00518115|EG002|Reported Event|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
11090061|NCT01526928|FG001|Participant Flow|Rociletinib 900 mg BID FB Capsules|Rociletinib free base (FB) dose 900 mg twice a day (BID). Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
11090062|NCT01526928|FG002|Participant Flow|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
11090063|NCT01526928|FG003|Participant Flow|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
11090064|NCT01526928|FG004|Participant Flow|Rociletinib 750 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
11090065|NCT01526928|FG005|Participant Flow|Rociletinib 1000 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
11090066|NCT01526928|OG000|Outcome|Rociletinib <900 mg BID FB Capsules|Rociletinib free base (FB) dose <900 mg twice a day (BID).
11090067|NCT01526928|OG001|Outcome|Rociletinib 900 mg BID FB Capsules|Rociletinib free base (FB) dose 900 mg twice a day (BID).
11090068|NCT01526928|OG002|Outcome|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
11090069|NCT01526928|OG003|Outcome|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
11090070|NCT01526928|OG004|Outcome|Rociletinib 750 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
11090071|NCT01526928|OG005|Outcome|Rociletinib 1000 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
11090072|NCT01526928|OG000|Outcome|Rociletinib 900 mg BID FB Capsules|Rociletinib free base (FB) dose 900 mg twice a day (BID)
11090073|NCT01526928|OG001|Outcome|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)
11090074|NCT01526928|OG002|Outcome|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)
11090075|NCT01526928|OG003|Outcome|Rociletinib 750 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)
11090076|NCT01526928|OG004|Outcome|Rociletinib 1000 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)
11090077|NCT01526928|OG000|Outcome|Rociletinib <900 mg BID FB Capsules|Rociletinib free base (FB) dose <900 mg twice a day (BID)
11090078|NCT01526928|OG001|Outcome|Rociletinib 900 mg BID FB Capsules|Rociletinib free base (FB) dose 900 mg twice a day (BID)
11090079|NCT01526928|OG002|Outcome|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)
11090080|NCT01526928|OG003|Outcome|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)
11090081|NCT01526928|OG004|Outcome|Rociletinib 750 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)
11090082|NCT01526928|OG005|Outcome|Rociletinib 1000 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)
11090083|NCT01526928|OG000|Outcome|Rociletinib 150 mg QD FB Capsules|Rociletinib free base (FB) dose 150 mg once a day (QD).
11090084|NCT01526928|OG001|Outcome|Rociletinib 200 mg QD FB Capsules|Rociletinib free base (FB) dose 200 mg once a day (QD).
11090085|NCT01526928|OG002|Outcome|Rociletinib 300 mg QD FB Capsules|Rociletinib free base (FB) dose 300 mg once a day (QD).
11090086|NCT01526928|OG003|Outcome|Rociletinib 450 mg QD FB Capsules|Rociletinib free base (FB) dose 450 mg once a day (QD).
11090087|NCT01526928|OG004|Outcome|Rociletinib 600 mg QD FB Capsules|Rociletinib free base (FB) dose 600 mg once a day (QD).
11090088|NCT01526928|OG005|Outcome|Rociletinib 900 mg QD FB Capsules|Rociletinib free base (FB) dose 900 mg once a day (QD).
11090089|NCT01526928|OG006|Outcome|Rociletinib 100 mg BID FB Capsules|Rociletinib free base (FB) dose 100 mg twice a day (BID).
11090090|NCT01526928|OG007|Outcome|Rociletinib 300 mg BID FB Capsules|Rociletinib free base (FB) dose 300 mg twice a day (BID).
11090091|NCT01526928|OG008|Outcome|Rociletinib 600 mg BID FB Capsules|Rociletinib free base (FB) dose 600 mg twice a day (BID).
11090092|NCT01526928|OG009|Outcome|Rociletinib 900 mg BID FB Capsules|Rociletinib free base (FB) dose 900 mg twice a day (BID).
11090093|NCT01526928|OG010|Outcome|Rociletinib 400 mg TID FB Capsules|Rociletinib free base (FB) dose 400 mg three times a day (TID).
11090094|NCT01526928|OG011|Outcome|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
11090095|NCT01526928|OG012|Outcome|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
11090096|NCT01526928|OG013|Outcome|Rociletinib 750 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
11090097|NCT01526928|OG014|Outcome|Rociletinib 1000 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
11090098|NCT01526928|OG010|Outcome|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
11090099|NCT01526928|OG011|Outcome|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
11090100|NCT01526928|OG012|Outcome|Rociletinib 750 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
11090101|NCT01526928|OG013|Outcome|Rociletinib 1000 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
11090102|NCT01526928|OG000|Outcome|Cmax Fasting|Rociletinib 150 mg FB single dose given while fasting
11090103|NCT01526928|OG001|Outcome|Cmax Fed|Rociletinib 150 mg FB single dose given with a high-fat breakfast
11090104|NCT01526928|OG000|Outcome|Tmax Fasting|Rociletinib 150 mg FB single dose given while fasting
11090105|NCT01526928|OG001|Outcome|Tmax Fed|Rociletinib 150 mg FB single dose given with a high-fat breakfast
11090106|NCT01526928|OG000|Outcome|AUC 0-24 Fasting|Rociletinib 150 mg FB single dose given while fasting
11090107|NCT01526928|OG001|Outcome|AUC 0-24 Fed|Rociletinib 150 mg FB single dose given with a high-fat breakfast
11090108|NCT01526928|OG000|Outcome|C24 Fasting|Rociletinib 150 mg FB single dose given while fasting
11090109|NCT01526928|OG001|Outcome|C24 Fed|Rociletinib 150 mg FB single dose given with a high-fat breakfast
11090110|NCT01526928|OG000|Outcome|T 1/2 Fasting|Rociletinib 150 mg FB single dose given while fasting
11090111|NCT01526928|OG001|Outcome|T 1/2 Fed|Rociletinib 150 mg FB single dose given with a high-fat breakfast
11090112|NCT01526928|OG000|Outcome|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
11090113|NCT01526928|OG001|Outcome|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
11090114|NCT01526928|EG000|Reported Event|Rociletinib <900 mg BID FB Capsules|Rociletinib free base (FB) dose <900 mg twice a day (BID).
11090115|NCT01526928|EG001|Reported Event|Rociletinib 900 mg BID FB Capsules|Rociletinib free base (FB) dose 900 mg twice a day (BID).
11090116|NCT01526928|EG002|Reported Event|Rociletinib 500 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
11090117|NCT01526928|EG003|Reported Event|Rociletinib 625 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
10851300|NCT00305682|EG004|Reported Event|Arm 5 - Previous Autologous Transplant|Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
10890605|NCT00518115|EG003|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890606|NCT00518115|EG004|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890607|NCT00518115|EG005|Reported Event|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890608|NCT00518115|EG006|Reported Event|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890609|NCT00518115|EG007|Reported Event|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890610|NCT00518115|EG008|Reported Event|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890611|NCT00518115|EG009|Reported Event|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
10890612|NCT00518154|BG000|Baseline|Change in Circulating CD4+ T-cell Count (Baseline vs. 16 Weeks|Participants will receive pyridostigmine 30mg three times per day for a period of 16 weeks. Pyridostigmine will be in addition (add-on) to their usual antiretroviral treatment schedule.
10890613|NCT00518154|FG000|Participant Flow|Pyridostigmine|"Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment. The study is open-label, proof-of-concept.~Pyridostigmine tablets: Patients will take 30mg tid PO for 12 weeks"
10890614|NCT00518154|OG000|Outcome|Pyridostigmine|"Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment. The study is open-label, proof-of-concept.~Pyridostigmine tablets: Patients will take 30mg tid PO for 12 weeks"
10890615|NCT00518154|EG000|Reported Event|Pyridostigmine|"Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment~Pyridostigmine tablets: Patients will take 30mg tid PO for 12 weeks"
10890616|NCT00518180|BG000|Baseline|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
10890617|NCT00518180|BG001|Baseline|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890618|NCT00518180|BG002|Baseline|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890619|NCT00518180|BG003|Baseline|Total|Total of all reporting groups
10890620|NCT00518180|FG000|Participant Flow|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
10890621|NCT00518180|FG001|Participant Flow|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890622|NCT00518180|FG002|Participant Flow|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890623|NCT00518180|OG000|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
10890624|NCT00518180|OG001|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890625|NCT00518180|OG002|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890626|NCT00518180|OG001|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
10890627|NCT00518180|OG002|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890628|NCT00518180|OG001|Outcome|HPV Alone|Three injections of the HPV vaccine were administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
10890629|NCT00518180|OG001|Outcome|HPV Alone|The three injections of the HPV vaccine was administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
10890630|NCT00518180|OG001|Outcome|MenACWY→Tdap → HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890631|NCT00518180|OG002|Outcome|Tdap → MenACWY →HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
10890632|NCT00518180|OG000|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
10890633|NCT00518180|OG001|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV at months 2, 4, and 8
10890634|NCT00518180|OG002|Outcome|Tdap → MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8
10890635|NCT00518180|EG000|Reported Event|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
10890636|NCT00518180|EG001|Reported Event|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdpa vaccine at month 1, followed by three injections of the HPV at months 2,4 and 8.
10890637|NCT00518180|EG002|Reported Event|Tdap → MenACWY → HPV|Tdpa was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2,4 and 8.
10890638|NCT00518206|BG000|Baseline|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
10890639|NCT00518206|BG001|Baseline|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
10890640|NCT00518206|BG002|Baseline|Total|Total of all reporting groups
10890641|NCT00518206|FG000|Participant Flow|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
11171052|NCT01999972|EG005|Reported Event|Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg|Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
10890642|NCT00518206|FG001|Participant Flow|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
10890643|NCT00518206|OG000|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
10890644|NCT00518206|OG001|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
10890645|NCT00518206|EG000|Reported Event|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
10890646|NCT00518206|EG001|Reported Event|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
10890647|NCT00518284|BG000|Baseline|Control|Following revascularization, participants did not receive any study drug treatment.
10890648|NCT00518284|BG001|Baseline|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
10890649|NCT00518284|BG002|Baseline|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
10890650|NCT00518284|BG003|Baseline|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
10890651|NCT00518284|BG004|Baseline|Total|Total of all reporting groups
10890652|NCT00518284|FG000|Participant Flow|Control|Following revascularization, participants did not receive any study drug treatment.
10890653|NCT00518284|FG001|Participant Flow|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
10890654|NCT00518284|FG002|Participant Flow|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
10890655|NCT00518284|FG003|Participant Flow|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
10890656|NCT00518284|OG000|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
10890657|NCT00518284|OG001|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
10890658|NCT00518284|OG002|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
10890659|NCT00518284|OG003|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
10890660|NCT00518284|EG000|Reported Event|Control|Following revascularization, participants did not receive any study drug treatment.
10890661|NCT00518284|EG001|Reported Event|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
10890662|NCT00518284|EG002|Reported Event|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
10890663|NCT00518284|EG003|Reported Event|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
10890664|NCT00518323|BG000|Baseline|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
10890665|NCT00518323|BG001|Baseline|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
10890666|NCT00518323|BG002|Baseline|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
11233187|NCT02424734|BG001|Baseline|Ceftaroline Fosamil: Term Neonates|Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10890667|NCT00518323|BG003|Baseline|Placebo|
10890668|NCT00518323|BG004|Baseline|Total|Total of all reporting groups
10890669|NCT00518323|FG000|Participant Flow|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
10890670|NCT00518323|FG001|Participant Flow|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
10890671|NCT00518323|FG002|Participant Flow|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
10890672|NCT00518323|FG003|Participant Flow|Placebo|
10890673|NCT00518323|OG000|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
10890674|NCT00518323|OG001|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
10890675|NCT00518323|OG002|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
10890676|NCT00518323|OG003|Outcome|Placebo|
10890677|NCT00518323|EG000|Reported Event|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
10890678|NCT00518323|EG001|Reported Event|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
10890679|NCT00518323|EG002|Reported Event|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
10890680|NCT00518323|EG003|Reported Event|Placebo|
10890681|NCT00518336|BG000|Baseline|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
10890682|NCT00518336|BG001|Baseline|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
10890683|NCT00518336|BG002|Baseline|Total|Total of all reporting groups
10890684|NCT00518336|FG000|Participant Flow|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
10890685|NCT00518336|FG001|Participant Flow|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
10890686|NCT00518336|OG000|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
10890687|NCT00518336|OG001|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
10890688|NCT00518336|EG000|Reported Event|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
10890689|NCT00518336|EG001|Reported Event|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
10890690|NCT00518349|BG000|Baseline|1 Prototype Colonoscope|Colonoscopy using prototype colonoscope
10890691|NCT00518349|BG001|Baseline|2 Standard Colonoscope|Colonoscopy using standard colonoscope without a passive bending function
10890692|NCT00518349|BG002|Baseline|Total|Total of all reporting groups
10890693|NCT00518349|FG000|Participant Flow|Prototype Colonoscope|Colonoscopy using prototype colonoscope
10890694|NCT00518349|FG001|Participant Flow|Standard Colonoscope|Colonoscopy using standard colonoscope without a passive bending function
10890695|NCT00518349|OG000|Outcome|1 Prototype Colonoscope|Colonoscopy using prototype colonoscope
11171053|NCT01999985|BG000|Baseline|All Participants|All Participants Who Received Study Treatment
10890696|NCT00518349|OG001|Outcome|2 Standard Colonoscope|Colonoscopy using standard colonoscope without a passive bending function
11090118|NCT01526928|EG004|Reported Event|Rociletinib 750 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
11090119|NCT01526928|EG005|Reported Event|Rociletinib 1000 mg BID HBr Tablets|Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
10890697|NCT00518349|EG000|Reported Event|Prototype Colonoscope|The prototype colonoscope is in effect a standard Olympus endoscope with one exception: about 10cm proximal to the distal, actively bending tip, there is a more falccid section which bends passively in all directions against external pressure. It is hypothesized that this will ease passage through sharp bends (flexures).
10849889|NCT00299130|BG001|Baseline|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
10890698|NCT00518349|EG001|Reported Event|Standard Colonoscope|Colonoscope without a distal actively bending section
10890699|NCT00518531|BG000|Baseline|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
10890700|NCT00518531|BG001|Baseline|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
10890701|NCT00518531|BG002|Baseline|Total|Total of all reporting groups
10890702|NCT00518531|FG000|Participant Flow|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week (QW) for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
10890703|NCT00518531|FG001|Participant Flow|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
10890704|NCT00518531|OG000|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
10890705|NCT00518531|OG001|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
10890706|NCT00518531|EG000|Reported Event|Treatment Period 1: Alendronate|Participants received alendronate 70 mg orally once a week in year 1.
10890707|NCT00518531|EG001|Reported Event|Treatment Period 1: Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months in year 1.
10890708|NCT00518531|EG002|Reported Event|Treatment Period 2: Alendronate|Participants who received denosumab 60 mg subcutaneously every 6 months in year 1 then received alendronate 70 mg orally once a week in year 2.
10890709|NCT00518531|EG003|Reported Event|Treatment Period 2: Denosumab|Participants who received alendronate 70 mg orally once a week in year 1 then received denosumab 60 mg subcutaneously every 6 months in year 2.
10890710|NCT00518622|BG000|Baseline|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890711|NCT00518622|BG001|Baseline|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890712|NCT00518622|BG002|Baseline|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890713|NCT00518622|BG003|Baseline|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890714|NCT00518622|BG004|Baseline|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890715|NCT00518622|BG005|Baseline|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
10890716|NCT00518622|BG006|Baseline|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
10890717|NCT00518622|BG007|Baseline|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
10890718|NCT00518622|BG008|Baseline|Total|Total of all reporting groups
10890719|NCT00518622|FG000|Participant Flow|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890720|NCT00518622|FG001|Participant Flow|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890721|NCT00518622|FG002|Participant Flow|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890722|NCT00518622|FG003|Participant Flow|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890723|NCT00518622|FG004|Participant Flow|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890724|NCT00518622|FG005|Participant Flow|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
10890725|NCT00518622|FG006|Participant Flow|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
10890726|NCT00518622|FG007|Participant Flow|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
10890727|NCT00518622|OG000|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890728|NCT00518622|OG001|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890729|NCT00518622|OG002|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890730|NCT00518622|OG003|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890731|NCT00518622|OG004|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890732|NCT00518622|OG005|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
10890733|NCT00518622|OG006|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
10890734|NCT00518622|OG007|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
10890735|NCT00518622|EG000|Reported Event|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
11090120|NCT01527006|BG000|Baseline|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
11090121|NCT01527006|BG001|Baseline|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
11090122|NCT01527006|BG002|Baseline|Total|Total of all reporting groups
10890736|NCT00518622|EG001|Reported Event|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890737|NCT00518622|EG002|Reported Event|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890738|NCT00518622|EG003|Reported Event|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890739|NCT00518622|EG004|Reported Event|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
10890740|NCT00518622|EG005|Reported Event|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
10890741|NCT00518622|EG006|Reported Event|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
10890742|NCT00518622|EG007|Reported Event|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
10890743|NCT00518687|BG000|Baseline|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
10890744|NCT00518687|BG001|Baseline|Placebo|Placebo : 0.5-ml single injection of matching placebo
10890745|NCT00518687|BG002|Baseline|Total|Total of all reporting groups
10890746|NCT00518687|FG000|Participant Flow|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
10890747|NCT00518687|FG001|Participant Flow|Placebo|Placebo : 0.5-ml single injection of matching placebo
10890748|NCT00518687|OG000|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
10890749|NCT00518687|OG001|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
10890750|NCT00518687|EG000|Reported Event|V710 (60 µg) Lyophilized|V710: 0.5-ml single injection of V710 (60 µg)
10890751|NCT00518687|EG001|Reported Event|Placebo|Placebo : 0.5-ml single injection of matching placebo
10890752|NCT00518713|BG000|Baseline|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
10890753|NCT00518713|BG001|Baseline|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
10890754|NCT00518713|BG002|Baseline|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
10890755|NCT00518713|BG003|Baseline|Placebo|tablets; orally; daily for 15-18 weeks
10890756|NCT00518713|BG004|Baseline|Total|Total of all reporting groups
10890757|NCT00518713|FG000|Participant Flow|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
10890758|NCT00518713|FG001|Participant Flow|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
10890759|NCT00518713|FG002|Participant Flow|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
10890760|NCT00518713|FG003|Participant Flow|Placebo|tablets; orally; daily for 15-18 weeks
10890761|NCT00518713|OG000|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
10890762|NCT00518713|OG001|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
10890763|NCT00518713|OG002|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
10890764|NCT00518713|OG003|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
10890765|NCT00518713|EG000|Reported Event|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
10890766|NCT00518713|EG001|Reported Event|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
10890767|NCT00518713|EG002|Reported Event|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
10890768|NCT00518713|EG003|Reported Event|Placebo|tablets; orally; daily for 15-18 weeks
10914725|NCT00632619|EG000|Reported Event|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
10914726|NCT00632619|EG001|Reported Event|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
10914727|NCT00632632|BG000|Baseline|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
10914728|NCT00632632|BG001|Baseline|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
10914729|NCT00632632|BG002|Baseline|Total|Total of all reporting groups
10914730|NCT00632632|FG000|Participant Flow|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
10914731|NCT00632632|FG001|Participant Flow|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
10914732|NCT00632632|OG000|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
10914733|NCT00632632|OG001|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
11171054|NCT01999985|FG000|Participant Flow|Part 1A Level 1|Participants given 30 mg Afatinib and 100 mg Dasatinib
11171055|NCT01999985|FG001|Participant Flow|Part 1A Level 2|Participants given 40 mg Afatinib and 100 mg Dasatinib
10849790|NCT00298272|BG001|Baseline|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
11171056|NCT01999985|FG002|Participant Flow|Part 1B|Participants given Afatinib 30 mg and 100 mg Dasatinib
10849791|NCT00298272|BG002|Baseline|Total|Total of all reporting groups
10849792|NCT00298272|FG000|Participant Flow|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
10849793|NCT00298272|FG001|Participant Flow|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
10849794|NCT00298272|OG000|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
10849795|NCT00298272|OG001|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
10849796|NCT00298272|OG000|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
10849797|NCT00298272|OG001|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
10849798|NCT00298272|EG000|Reported Event|Double-Blind Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
10849799|NCT00298272|EG001|Reported Event|Double-Blind Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
10849800|NCT00298272|EG002|Reported Event|Cumulative Rituximab|The cumulative rituximab treatment group included all participants who received rituximab at any time during the study, including participants who received rituximab in the double-blind period and did not participate in the OL period, those who received placebo in the double-blind period and rituximab in the OL, and those who received rituximab in the double-blind and OL periods. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
10849801|NCT00298363|BG000|Baseline|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
10849802|NCT00298363|BG001|Baseline|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
10849803|NCT00298363|BG002|Baseline|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
10849804|NCT00298363|BG003|Baseline|Total|Total of all reporting groups
10849805|NCT00298363|FG000|Participant Flow|Tenofovir DF|Participants in this group were randomized to receive double-blind (DB) TDF 300 mg + FTC)/TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to open-label (OL) FTC/TDF (this study enrolled participants with decompensated liver disease, and early intervention strategies were provided if profound viral suppression was not achieved quickly).
10849806|NCT00298363|FG001|Participant Flow|FTC/TDF|Participants in this group were randomized to receive DB FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
10849807|NCT00298363|FG002|Participant Flow|Entecavir|Participants in this group were randomized to receive DB ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
10849808|NCT00298363|OG000|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
10849809|NCT00298363|OG001|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
10849810|NCT00298363|OG002|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
10849811|NCT00298363|OG003|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
10849812|NCT00298363|OG002|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
10849813|NCT00298363|OG003|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
10849814|NCT00298363|OG001|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
10849815|NCT00298363|EG000|Reported Event|Double Blind TDF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo
11233188|NCT02424734|BG002|Baseline|Ceftaroline Fosamil: Preterm Neonates|Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10890769|NCT00518882|BG000|Baseline|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
10890770|NCT00518882|BG001|Baseline|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
10890771|NCT00518882|BG002|Baseline|Total|Total of all reporting groups
10890772|NCT00518882|FG000|Participant Flow|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
10890773|NCT00518882|FG001|Participant Flow|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
10890774|NCT00518882|OG000|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
10890775|NCT00518882|OG001|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
10890776|NCT00518882|EG000|Reported Event|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
10890777|NCT00518882|EG001|Reported Event|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
11171057|NCT01999985|OG000|Outcome|Dose Escalation and Expansion|All Participants who received treatment.
11171058|NCT01999985|EG000|Reported Event|Part 1A Level 1|Participants were given 30 mg Afatinib and 100 mg Dasatinib
10890778|NCT00518973|BG000|Baseline|Placebo|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
11171059|NCT01999985|EG001|Reported Event|Part 1A Level 2|Participants were given 40 mg Afatinib and 100 mg Dasatinib
10890779|NCT00518973|BG001|Baseline|Quetiapine|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
10890780|NCT00518973|BG002|Baseline|Total|Total of all reporting groups
10890781|NCT00518973|FG000|Participant Flow|Placebo|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
10914734|NCT00632632|EG000|Reported Event|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
10914735|NCT00632632|EG001|Reported Event|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
11171060|NCT01999985|EG002|Reported Event|Part 1B|Participants given Afatinib 30 mg and 100 mg Dasatinib
11171061|NCT02000154|BG000|Baseline|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
11233189|NCT02424734|BG003|Baseline|Total|Total of all reporting groups
11335600|NCT03553940|BG001|Baseline|Placebo|A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
11335601|NCT03553940|BG002|Baseline|Total|Total of all reporting groups
11171062|NCT02000154|FG000|Participant Flow|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
11171063|NCT02000154|OG000|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
11171064|NCT02000154|EG000|Reported Event|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
11171065|NCT02000180|BG000|Baseline|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
11171066|NCT02000180|BG001|Baseline|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
11171067|NCT02000180|BG002|Baseline|Total|Total of all reporting groups
11171068|NCT02000180|FG000|Participant Flow|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
11171069|NCT02000180|FG001|Participant Flow|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
11171070|NCT02000180|OG000|Outcome|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
11171071|NCT02000180|OG001|Outcome|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
11171072|NCT02000180|EG000|Reported Event|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
11171073|NCT02000180|EG001|Reported Event|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
11171074|NCT02000440|BG000|Baseline|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
11171075|NCT02000440|FG000|Participant Flow|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
11171076|NCT02000440|OG000|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
11171077|NCT02000440|EG000|Reported Event|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
11171078|NCT02000531|BG000|Baseline|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
11171079|NCT02000531|BG001|Baseline|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
11171080|NCT02000531|BG002|Baseline|Total|Total of all reporting groups
11171081|NCT02000531|FG000|Participant Flow|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
11171082|NCT02000531|FG001|Participant Flow|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
11171083|NCT02000531|OG000|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
11171084|NCT02000531|OG001|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
11171085|NCT02000531|EG000|Reported Event|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
11171086|NCT02000531|EG001|Reported Event|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
11171087|NCT02000583|BG000|Baseline|Aerobic Exercise Group|"Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks~Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks"
11171088|NCT02000583|BG001|Baseline|Control Group|"Standard of Care exercise recommendations~Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program."
11171089|NCT02000583|BG002|Baseline|Total|Total of all reporting groups
11171090|NCT02000583|FG000|Participant Flow|Aerobic Exercise Group|"Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks~Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks"
11171091|NCT02000583|FG001|Participant Flow|Control Group|"Standard of Care exercise recommendations~Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program."
11171092|NCT02000583|OG000|Outcome|Aerobic Exercise Group|"Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks~Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks"
11171093|NCT02000583|OG001|Outcome|Control Group|"Standard of Care exercise recommendations~Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program."
11171094|NCT02000583|EG000|Reported Event|Aerobic Exercise Group|"Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks~Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks"
11171095|NCT02000583|EG001|Reported Event|Control Group|"Standard of Care exercise recommendations~Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program."
11171096|NCT02000752|BG000|Baseline|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
11171097|NCT02000752|BG001|Baseline|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
10890782|NCT00518973|FG001|Participant Flow|Quetiapine|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
10890783|NCT00518973|OG000|Outcome|Placebo|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
10890784|NCT00518973|OG001|Outcome|Quetiapine|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
10890785|NCT00518973|EG000|Reported Event|Placebo|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
10890786|NCT00518973|EG001|Reported Event|Quetiapine|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
10890787|NCT00518986|BG000|Baseline|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
11171098|NCT02000752|BG002|Baseline|Total|Total of all reporting groups
11171099|NCT02000752|FG000|Participant Flow|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
11171100|NCT02000752|FG001|Participant Flow|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
11171101|NCT02000752|OG000|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
11171102|NCT02000752|OG001|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
11335620|NCT03554005|FG005|Participant Flow|PEG Interferon Alfa-2b 7.5 mcg/kg OW|Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10890788|NCT00518986|BG001|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
10890789|NCT00518986|BG002|Baseline|Total|Total of all reporting groups
10890790|NCT00518986|FG000|Participant Flow|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
10890791|NCT00518986|FG001|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
10890792|NCT00518986|OG000|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
10890793|NCT00518986|OG001|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
10890794|NCT00518986|EG000|Reported Event|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
10890795|NCT00518986|EG001|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
10890796|NCT00519077|BG000|Baseline|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
10890797|NCT00519077|FG000|Participant Flow|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
10890798|NCT00519077|OG000|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
10914736|NCT00632736|BG000|Baseline|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
11171103|NCT02000752|EG000|Reported Event|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
11171104|NCT02000752|EG001|Reported Event|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
10890799|NCT00519077|EG000|Reported Event|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
10890800|NCT00519194|BG000|Baseline|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
10890801|NCT00519194|FG000|Participant Flow|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure"
10890802|NCT00519194|OG000|Outcome|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
10890803|NCT00519194|EG000|Reported Event|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
10890804|NCT00519285|BG000|Baseline|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
10890805|NCT00519285|BG001|Baseline|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
10890806|NCT00519285|BG002|Baseline|Total|Total of all reporting groups
10890807|NCT00519285|FG000|Participant Flow|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
10890808|NCT00519285|FG001|Participant Flow|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
10890809|NCT00519285|OG000|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
10890810|NCT00519285|OG001|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
11171105|NCT02000817|BG000|Baseline|Placebo|Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
10890811|NCT00519285|EG000|Reported Event|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
11171106|NCT02000817|BG001|Baseline|Otelixizumab 9 mg|Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
11171107|NCT02000817|BG002|Baseline|Otelixizumab 18 mg|Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
10890812|NCT00519285|EG001|Reported Event|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
11171108|NCT02000817|BG003|Baseline|Otelixizumab 27 mg|Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
11171109|NCT02000817|BG004|Baseline|Total|Total of all reporting groups
10890813|NCT00519376|BG000|Baseline|GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq|Participants were administered single dose of four of the five following treatments: GW642444M (25, 50 and 100 µg), GW642444H (100 µg) or placebo. Each participant received doses of GW642444M in an ascending dose manner with GW642444H and placebo randomly interspersed as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890814|NCT00519376|FG000|Participant Flow|Seq 1: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: Placebo (PB), GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg. Each participants received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890815|NCT00519376|FG001|Participant Flow|Seq 2: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890816|NCT00519376|FG002|Participant Flow|Seq 3: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890817|NCT00519376|FG003|Participant Flow|Seq 4: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890818|NCT00519376|FG004|Participant Flow|Seq 5: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
11171110|NCT02000817|FG000|Participant Flow|Placebo|Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
11171111|NCT02000817|FG001|Participant Flow|Otelixizumab 9 mg|Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
11171112|NCT02000817|FG002|Participant Flow|Otelixizumab 18 mg|Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
10890819|NCT00519376|FG005|Participant Flow|Seq 6: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890820|NCT00519376|FG006|Participant Flow|Seq 7: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890821|NCT00519376|FG007|Participant Flow|Seq 8: PB, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890822|NCT00519376|FG008|Participant Flow|Seq 9: GW642444M 25 µg, PB, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890823|NCT00519376|FG009|Participant Flow|Seq 10: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890824|NCT00519376|FG010|Participant Flow|Seq 11: PB, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890825|NCT00519376|FG011|Participant Flow|Seq 12: GW642444M 25 µg, GW642444H 100 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890826|NCT00519376|FG012|Participant Flow|Seq 13: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890827|NCT00519376|FG013|Participant Flow|Seq 14: GW642444H 100 µg, PB, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, Placebo, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890828|NCT00519376|FG014|Participant Flow|Seq 15: GW642444H 100 µg, GW642444M 25 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890829|NCT00519376|FG015|Participant Flow|Seq 16: GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890830|NCT00519376|OG000|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890831|NCT00519376|OG001|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
11171113|NCT02000817|FG003|Participant Flow|Otelixizumab 27 mg|Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
10890832|NCT00519376|OG002|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890833|NCT00519376|OG003|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890834|NCT00519376|OG004|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890835|NCT00519376|EG000|Reported Event|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890836|NCT00519376|EG001|Reported Event|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890837|NCT00519376|EG002|Reported Event|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
11171114|NCT02000817|OG000|Outcome|Placebo|Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
11171115|NCT02000817|OG001|Outcome|Otelixizumab 9 mg|Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
11171116|NCT02000817|OG002|Outcome|Otelixizumab 18 mg|Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
11171117|NCT02000817|OG003|Outcome|Otelixizumab 27 mg|Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
11171118|NCT02000817|OG000|Outcome|Otelixizumab 9 mg|Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
10849816|NCT00298363|EG001|Reported Event|Double Blind FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo
10890838|NCT00519376|EG003|Reported Event|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890839|NCT00519376|EG004|Reported Event|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
10890840|NCT00519428|BG000|Baseline|Escitalopram + Bupropion|escitalopram plus bupropion XL
10890841|NCT00519428|BG001|Baseline|Escitalopram|escitalopram monotherapy
10890842|NCT00519428|BG002|Baseline|Bupropion|bupropion XL monotherapy
10890843|NCT00519428|BG003|Baseline|Total|Total of all reporting groups
10890844|NCT00519428|FG000|Participant Flow|Escitalopram + Bupropion|escitalopram plus bupropion
10890845|NCT00519428|FG001|Participant Flow|Escitalopram|escitalopram monotherapy
10890846|NCT00519428|FG002|Participant Flow|Bupropion|bupropion monotherapy
10890847|NCT00519428|OG000|Outcome|Escitalopram + Bupropion|escitalopram plus bupropion XL
10890848|NCT00519428|OG001|Outcome|Escitalopram|escitalopram monotherapy
10890849|NCT00519428|OG002|Outcome|Bupropion|bupropion XL monotherapy
10890850|NCT00519428|OG000|Outcome|Escitalopram + Bupropion|"escitalopram plus bupropion XL as dual treatment (i.e., this is not a SINGLE treatment arm; all patients assigned this arm received both medications)~escitalopram + bupropion: same dosing schedule as for monotherapy"
10890851|NCT00519428|OG001|Outcome|Escitalopram|"escitalopram monotherapy~escitalopram: 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted"
10890852|NCT00519428|OG002|Outcome|Bupropion|"bupropion XL monotherapy~bupropion XL: 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted"
10890853|NCT00519428|EG000|Reported Event|Escitalopram + Bupropion|"escitalopram plus bupropion XL~escitalopram + bupropion: same dosing schedule as for monotherapy"
10890854|NCT00519428|EG001|Reported Event|Escitalopram|"escitalopram monotherapy~escitalopram: 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted"
10890855|NCT00519428|EG002|Reported Event|Bupropion|"bupropion XL monotherapy~bupropion XL: 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted"
10890856|NCT00519532|BG000|Baseline|Rotigotine|Rotigotine Transdermal Patch
10890857|NCT00519532|FG000|Participant Flow|Rotigotine|Rotigotine Transdermal Patch
10890858|NCT00519532|OG000|Outcome|Rotigotine|Rotigotine Transdermal Patch
10890859|NCT00519532|EG000|Reported Event|Rotigotine|Rotigotine Transdermal Patch
10890860|NCT00519584|BG000|Baseline|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
10890861|NCT00519584|BG001|Baseline|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
10890862|NCT00519584|BG002|Baseline|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
10890863|NCT00519584|BG003|Baseline|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
10890864|NCT00519584|BG004|Baseline|Total|Total of all reporting groups
10890865|NCT00519584|FG000|Participant Flow|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
10890866|NCT00519584|FG001|Participant Flow|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
10890867|NCT00519584|FG002|Participant Flow|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
10890868|NCT00519584|FG003|Participant Flow|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
10890869|NCT00519584|OG000|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
10890870|NCT00519584|OG001|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
10890871|NCT00519584|OG002|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
10890872|NCT00519584|OG003|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
10890873|NCT00519584|EG000|Reported Event|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
11171119|NCT02000817|OG001|Outcome|Otelixizumab 18 mg|Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
10890874|NCT00519584|EG001|Reported Event|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
10890875|NCT00519584|EG002|Reported Event|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
10890876|NCT00519584|EG003|Reported Event|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
10890877|NCT00519623|BG000|Baseline|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
10890878|NCT00519623|FG000|Participant Flow|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
10890879|NCT00519623|OG000|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
10890880|NCT00519623|EG000|Reported Event|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
10890881|NCT00519636|BG000|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
10890882|NCT00519636|BG001|Baseline|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
10890883|NCT00519636|BG002|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10890884|NCT00519636|BG003|Baseline|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
10890885|NCT00519636|BG004|Baseline|Total|Total of all reporting groups
10890886|NCT00519636|FG000|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
10890887|NCT00519636|FG001|Participant Flow|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
10890888|NCT00519636|FG002|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10890889|NCT00519636|FG003|Participant Flow|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
10890890|NCT00519636|OG000|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
11090123|NCT01527006|FG000|Participant Flow|Cohort ( ≥ 2 to < 7 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
11171120|NCT02000817|OG002|Outcome|Otelixizumab 27 mg|Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
10890891|NCT00519636|OG001|Outcome|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
10890892|NCT00519636|OG002|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10890893|NCT00519636|OG003|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
10890894|NCT00519636|OG001|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10890895|NCT00519636|OG002|Outcome|Total|All subjects on both arms preference.
10890896|NCT00519636|OG001|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
10890897|NCT00519636|OG002|Outcome|Total|All Subjects on both arms preference.
10890898|NCT00519636|EG000|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
10890899|NCT00519636|EG001|Reported Event|Fluticasone Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
10890900|NCT00519636|EG002|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
10890901|NCT00519636|EG003|Reported Event|Placebo -FP|Subject who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
10890902|NCT00519649|BG000|Baseline|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
11171121|NCT02000817|EG000|Reported Event|Placebo|Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days
11171122|NCT02000817|EG001|Reported Event|Otelixizumab 9 mg|Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
11171123|NCT02000817|EG002|Reported Event|Otelixizumab 18 mg|Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
11171124|NCT02000817|EG003|Reported Event|Otelixizumab 27 mg|Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
10849817|NCT00298363|EG002|Reported Event|Double Blind ETV|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo
11090124|NCT01527006|FG001|Participant Flow|Cohort ( ≥ 7 to < 12 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
11090125|NCT01527006|OG000|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
11090126|NCT01527006|OG001|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
11090127|NCT01527006|OG002|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
11090128|NCT01527006|OG003|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
11090129|NCT01527006|OG000|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
11090130|NCT01527006|OG001|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
11090131|NCT01527006|EG000|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
10890903|NCT00519649|FG000|Participant Flow|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
10890904|NCT00519649|OG000|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
10890905|NCT00519649|EG000|Reported Event|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
10890906|NCT00519779|BG000|Baseline|Placebo|Placebo oral Omega-3 fish oil supplementation
10890907|NCT00519779|BG001|Baseline|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
10890908|NCT00519779|BG002|Baseline|Total|Total of all reporting groups
10890909|NCT00519779|FG000|Participant Flow|Placebo|Placebo oral Omega-3 fish oil supplementation
10890910|NCT00519779|FG001|Participant Flow|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
10890911|NCT00519779|OG000|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
10890912|NCT00519779|OG001|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
10890913|NCT00519779|EG000|Reported Event|Placebo|Placebo oral Omega-3 fish oil supplementation
10890914|NCT00519779|EG001|Reported Event|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
10890915|NCT00519831|BG000|Baseline|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
10890916|NCT00519831|FG000|Participant Flow|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
10914737|NCT00632736|FG000|Participant Flow|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
10890917|NCT00519831|OG000|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
10890918|NCT00519831|EG000|Reported Event|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
10890919|NCT00519896|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
10890920|NCT00519896|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
10890921|NCT00519896|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
10890922|NCT00519896|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
11090132|NCT01527006|EG001|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
11090133|NCT01527006|EG002|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
10890923|NCT00520013|BG000|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.~bevacizumab~paclitaxel~carboplatin"
10890924|NCT00520013|BG001|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.~bevacizumab~erlotinib~paclitaxel~carboplatin"
11090134|NCT01527006|EG003|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
11090135|NCT01527045|BG000|Baseline|Primary - Reg A (Flu/TBI)|"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0.~TRANSPLANT: Patients undergo donor PBSC transplant on day 0.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
11090136|NCT01527045|BG001|Baseline|Primary - Reg B (TBI Alone)|"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0.~TRANSPLANT: Patients undergo donor PBSC transplant on day 0.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
10890925|NCT00520013|BG002|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation: None~bevacizumab~paclitaxel~carboplatin"
10890926|NCT00520013|BG003|Baseline|Total|Total of all reporting groups
10890927|NCT00520013|FG000|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
10890928|NCT00520013|FG001|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
10914738|NCT00632736|OG000|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
10849818|NCT00298363|EG003|Reported Event|Open Label FTC/TDF|Participants in this group were randomized to receive TDF, FTC/TDF, or ETV at the beginning of the study, but switched to open label FTC/TDF during the study.
10849819|NCT00298363|EG004|Reported Event|All TDF|Participants in this group received a TDF-containing treatment (all double-blind TDF, FTC/TDF, or open-label FTC/TDF) during the study.
10849820|NCT00298389|BG000|Baseline|Non Smokers|Non smokers included no history of respiratory or allergic disease, normal baseline spirometry
11171125|NCT02000908|BG000|Baseline|Realief Therapy|"Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy.~photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser."
10890929|NCT00520013|FG002|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation: None"
10890930|NCT00520013|OG000|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
10890931|NCT00520013|OG001|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
10890932|NCT00520013|EG000|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
10890933|NCT00520013|EG001|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
10890934|NCT00520039|BG000|Baseline|Standard Care Plus OMM|Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate, at each of the first 3 study visits. Subjects will also receive standard care for otitis media from their referring physician.
10890935|NCT00520039|BG001|Baseline|Standard Care Only|Subjects will receive standard care only for otitis media from their regular referring physician
10890936|NCT00520039|BG002|Baseline|Total|Total of all reporting groups
11233190|NCT02424734|FG000|Participant Flow|Ceftaroline Fosamil: Young Infants|Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10890937|NCT00520039|FG000|Participant Flow|Standard Care Plus OMM (SC+OMM)|"Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician.~osteopathic manipulative medicine (OMM): At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol."
10890938|NCT00520039|FG001|Participant Flow|Standard Care Only (SCO)|Subjects will receive standard care only for otitis media from their regular referring physician
10890939|NCT00520039|OG000|Outcome|Standard Care Plus OMM (SC+OMM)|"Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician.~Osteopathic manipulative medicine (OMM): At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol."
10890940|NCT00520039|OG001|Outcome|Standard Care Only (SCO)|Subjects will receive standard care only for otitis media from their regular referring physician
10890941|NCT00520039|OG000|Outcome|Before OMM|"Result of tympanogram reading before OMM.~Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician."
10890942|NCT00520039|OG001|Outcome|After OMM|"Result of tympanogram reading after OMM.~Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician."
10890943|NCT00520039|EG000|Reported Event|Standard Care Plus OMM|"Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician.~osteopathic manipulative medicine (OMM): At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.~There were no Serious Adverse Events reported."
10890944|NCT00520039|EG001|Reported Event|Standard Care Only|"Subjects will receive standard care only for otitis media from their regular referring physician.~There were no Serious Adverse Events reported."
10890945|NCT00520130|BG000|Baseline|Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
10890946|NCT00520130|BG001|Baseline|Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
10890947|NCT00520130|BG002|Baseline|Total|Total of all reporting groups
10890948|NCT00520130|FG000|Participant Flow|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
10890949|NCT00520130|FG001|Participant Flow|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
10890950|NCT00520130|OG000|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
10890951|NCT00520130|OG001|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
10890952|NCT00520130|OG000|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
10890953|NCT00520130|OG001|Outcome|B - Cyclosporine (AC Arm)|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
10890954|NCT00520130|OG001|Outcome|B - Cyclosporine (C) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
10890955|NCT00520130|OG000|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm Rituximab: 375 mg/m2 IV, day 1 for patients with cluster of differentiation 20 (CD20)-positive disease Allogenic stem cell transplant (ASCT):Allogenic stem cell transplant Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna:1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11 Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
10890956|NCT00520130|EG000|Reported Event|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm~Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease~Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant~Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3~TMS: Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
10914739|NCT00632736|EG000|Reported Event|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
10914740|NCT00632749|BG000|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11233191|NCT02424734|FG001|Participant Flow|Ceftaroline Fosamil: Term Neonates|Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10890957|NCT00520130|EG001|Reported Event|B - Cyclosporine (AC) Arm|"AC Arm~Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease~Cyclosporine: Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if GVHD does not develop.~Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant~Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy EPOCH-F: Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m2/d"
10890958|NCT00520234|BG000|Baseline|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
10890959|NCT00520234|BG001|Baseline|Placebo|Normal Saline 100 cc IV daily
10890960|NCT00520234|BG002|Baseline|Total|Total of all reporting groups
10890961|NCT00520234|FG000|Participant Flow|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
10890962|NCT00520234|FG001|Participant Flow|Placebo|Normal Saline 100 cc IV daily
10890963|NCT00520234|OG000|Outcome|Prophylaxis|Caspofungin 50mg IV daily
10890964|NCT00520234|OG001|Outcome|Placebo|Normal Saline 100 cc IV daily
10890965|NCT00520234|OG000|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
11233192|NCT02424734|FG002|Participant Flow|Ceftaroline Fosamil: Preterm Neonates|Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10890966|NCT00520234|EG000|Reported Event|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
10890967|NCT00520234|EG001|Reported Event|Placebo|Normal Saline 100 cc IV daily
10890968|NCT00520286|BG000|Baseline|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
10890969|NCT00520286|BG001|Baseline|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
10890970|NCT00520286|BG002|Baseline|Total|Total of all reporting groups
10890971|NCT00520286|FG000|Participant Flow|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
10890972|NCT00520286|FG001|Participant Flow|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
10890973|NCT00520286|OG000|Outcome|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
10890974|NCT00520286|OG001|Outcome|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
10890975|NCT00520286|EG000|Reported Event|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
11233193|NCT02424734|OG000|Outcome|Ceftaroline Fosamil: Young Infants|Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10890976|NCT00520286|EG001|Reported Event|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
10890977|NCT00520299|BG000|Baseline|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
10890978|NCT00520299|BG001|Baseline|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
10890979|NCT00520299|BG002|Baseline|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
10890980|NCT00520299|BG003|Baseline|Total|Total of all reporting groups
10890981|NCT00520299|FG000|Participant Flow|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
10890982|NCT00520299|FG001|Participant Flow|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
10890983|NCT00520299|FG002|Participant Flow|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
10890984|NCT00520299|OG000|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
10890985|NCT00520299|OG001|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
10890986|NCT00520299|OG002|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
10890987|NCT00520299|EG000|Reported Event|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects who received 40 IU/m^2/week of ADI-PEG 20
10890988|NCT00520299|EG001|Reported Event|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects who received 80 IU/m^2/week of ADI-PEG 20
10890989|NCT00520299|EG002|Reported Event|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects who received 160 IU/m^2/week of ADI-PEG 20
10890990|NCT00520351|BG000|Baseline|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
10890991|NCT00520351|BG001|Baseline|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
10890992|NCT00520351|BG002|Baseline|Total|Total of all reporting groups
10890993|NCT00520351|FG000|Participant Flow|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
10890994|NCT00520351|FG001|Participant Flow|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
11171126|NCT02000908|BG001|Baseline|Sham Treatment|"The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control.~After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy.~photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser.~Sham treatment: All patients in sham treatment arm cross over to laser therapy followed by physiotherapy~Physiotherapy: Chiropractic massage and lymphedema treatment"
11171127|NCT02000908|BG002|Baseline|Total|Total of all reporting groups
11171128|NCT02000908|FG000|Participant Flow|Realief Therapy|"Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy.~photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser."
11171129|NCT02000908|FG001|Participant Flow|Sham Treatment|"The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control.~After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy.~photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser.~Sham treatment: All patients in sham treatment arm cross over to laser therapy followed by physiotherapy~Physiotherapy: Chiropractic massage and lymphedema treatment"
11171130|NCT02000908|OG000|Outcome|Realief Therapy|"Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy.~photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser."
11171131|NCT02000908|OG001|Outcome|Sham Treatment|"The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control.~After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy.~photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser.~Sham treatment: All patients in sham treatment arm cross over to laser therapy followed by physiotherapy~Physiotherapy: Chiropractic massage and lymphedema treatment"
11171132|NCT02000908|EG000|Reported Event|Realief Therapy|"Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy.~photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser."
11171133|NCT02000908|EG001|Reported Event|Sham Treatment|"The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control.~After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy.~photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser.~Sham treatment: All patients in sham treatment arm cross over to laser therapy followed by physiotherapy~Physiotherapy: Chiropractic massage and lymphedema treatment"
11171134|NCT02000921|BG000|Baseline|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
10890995|NCT00520351|OG000|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
10890996|NCT00520351|OG001|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
10890997|NCT00520351|EG000|Reported Event|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
10890998|NCT00520351|EG001|Reported Event|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
10890999|NCT00520403|BG000|Baseline|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
10891000|NCT00520403|FG000|Participant Flow|Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
10891001|NCT00520403|OG000|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
10891002|NCT00520403|EG000|Reported Event|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
10891003|NCT00520468|BG000|Baseline|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
10891004|NCT00520468|FG000|Participant Flow|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
10891005|NCT00520468|OG000|Outcome|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
10891006|NCT00520468|EG000|Reported Event|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
10891007|NCT00520481|BG000|Baseline|Cixutumumab 10 mg/kg|Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
10891008|NCT00520481|BG001|Baseline|Cixutumumab 20 mg /kg|Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
10891009|NCT00520481|BG002|Baseline|Total|Total of all reporting groups
10891010|NCT00520481|FG000|Participant Flow|IMC-A12 (Cixutumumab) 10 mg/kg|Cixutumumab was administered at 10 milligrams/kilogram (mg/kg) as intravenous (i.v.) infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
10891011|NCT00520481|FG001|Participant Flow|Cixutumumab 20 mg/kg|Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
10891012|NCT00520481|OG000|Outcome|Cixutumumab 10 mg/kg|Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
10891013|NCT00520481|OG001|Outcome|Cixutumumab 20 mg/kg|Cixutumumab was administered at or 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
10891014|NCT00520481|OG000|Outcome|Cixutumumab 20 mg/kg|Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
10891015|NCT00520481|OG001|Outcome|Cixutumumab 20 mg/kg|Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
10891016|NCT00520481|EG000|Reported Event|Cixutumumab 10 mg/kg|Cixutumumab was administered at 10 mg/kg as intravenous (i.v.) infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
10891017|NCT00520481|EG001|Reported Event|Cixutumumab 20 mg/kg|Cixutumumab was administered at 20mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
10891018|NCT00520494|BG000|Baseline|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
10891019|NCT00520494|FG000|Participant Flow|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
10891020|NCT00520494|OG000|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
10891021|NCT00520494|EG000|Reported Event|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
10891022|NCT00520533|BG000|Baseline|cG250 + Sunitinib|"Treatment (cycle 1):~cG250 10mg/m² IV weekly x 5 doses (1st & 5th doses trace-labelled with 124I)~Sunitinib 50 mg/day orally x 4 weeks commencing day 8~Followed by two-week break~Treatment (cycle 2 - investigator discretion):~cG250 10mg/m² IV weekly x4 doses~Sunitinib 50 mg/day orally x 4 weeks (commencing concurrently)~Followed by two-week break~Up to 2 cycles available on-study."
10891023|NCT00520533|FG000|Participant Flow|cG250 + Sunitinib|"Treatment (cycle 1):~cG250 10mg/m² IV weekly x 5 doses (1st & 5th doses trace-labelled with 124I)~Sunitinib 50 mg/day orally x 4 weeks commencing day 8~Followed by two-week break~Treatment (cycle 2 - investigator discretion):~cG250 10mg/m² IV weekly x4 doses~Sunitinib 50 mg/day orally x 4 weeks (commencing concurrently)~Followed by two-week break~Up to 2 cycles available on-study."
10891024|NCT00520533|OG000|Outcome|cG250 and Sunitinib|"Treatment (cycle 1):~cG250 10mg/m² IV weekly x 5 doses (1st & 5th doses trace-labelled with 124I)~Sunitinib 50 mg/day orally x 4 weeks commencing day 8~Followed by two-week break~Treatment (cycle 2 - investigator discretion):~cG250 10mg/m² IV weekly x4 doses~Sunitinib 50 mg/day orally x 4 weeks (commencing concurrently)~Followed by two-week break~Up to 2 cycles available on-study."
10891025|NCT00520533|OG000|Outcome|cG250 + Sunitinib|"Treatment (cycle 1):~cG250 10mg/m² IV weekly x 5 doses (1st & 5th doses trace-labelled with 124I)~Sunitinib 50 mg/day orally x 4 weeks commencing day 8~Followed by two-week break~Treatment (cycle 2 - investigator discretion):~cG250 10mg/m² IV weekly x4 doses~Sunitinib 50 mg/day orally x 4 weeks (commencing concurrently)~Followed by two-week break~Up to 2 cycles available on-study."
10891026|NCT00520533|EG000|Reported Event|cG250 + Sunitinib|"Treatment (cycle 1):~cG250 10mg/m² IV weekly x 5 doses (1st & 5th doses trace-labelled with 124I)~Sunitinib 50 mg/day orally x 4 weeks commencing day 8~Followed by two-week break~Treatment (cycle 2 - investigator discretion):~cG250 10mg/m² IV weekly x4 doses~Sunitinib 50 mg/day orally x 4 weeks (commencing concurrently)~Followed by two-week break~Up to 2 cycles available on-study."
10891027|NCT00520546|BG000|Baseline|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
10891028|NCT00520546|FG000|Participant Flow|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
10891029|NCT00520546|OG000|Outcome|[18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET)|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
10914741|NCT00632749|BG001|Baseline|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11233194|NCT02424734|OG001|Outcome|Ceftaroline Fosamil: Term Neonates|Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
11233195|NCT02424734|OG002|Outcome|Ceftaroline Fosamil: Preterm Neonates|Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10849821|NCT00298389|BG001|Baseline|Smokers|Smoking history of at least 10 pack years
10849822|NCT00298389|BG002|Baseline|COPD|Patients with stable COPD
10849823|NCT00298389|BG003|Baseline|Total|Total of all reporting groups
10891030|NCT00520546|OG001|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2 weighed (T2w) spin echo (SE) sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
10891031|NCT00520546|OG002|Outcome|PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)|PET images at 45 min p.i. (post injection) and 65 min p.i. were fused with transversal endorectal and QBody T2 weighed (T2w) MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
10891032|NCT00520546|OG000|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
10891033|NCT00520546|OG001|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
10891034|NCT00520546|OG002|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
10891035|NCT00520546|EG000|Reported Event|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
10891036|NCT00520572|BG000|Baseline|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
10891037|NCT00520572|BG001|Baseline|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
10891038|NCT00520572|BG002|Baseline|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
10891039|NCT00520572|BG003|Baseline|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
10891040|NCT00520572|BG004|Baseline|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
10891041|NCT00520572|BG005|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
10891042|NCT00520572|BG006|Baseline|Total|Total of all reporting groups
10891043|NCT00520572|FG000|Participant Flow|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
10891044|NCT00520572|FG001|Participant Flow|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
10891045|NCT00520572|FG002|Participant Flow|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
10891046|NCT00520572|FG003|Participant Flow|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
10891047|NCT00520572|FG004|Participant Flow|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
10891048|NCT00520572|FG005|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
10891049|NCT00520572|OG000|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
10891050|NCT00520572|OG001|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
10891051|NCT00520572|OG002|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
10891052|NCT00520572|OG003|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
10891053|NCT00520572|OG004|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
10891054|NCT00520572|OG005|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
10891055|NCT00520572|EG000|Reported Event|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
10891056|NCT00520572|EG001|Reported Event|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
10891057|NCT00520572|EG002|Reported Event|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
10891058|NCT00520572|EG003|Reported Event|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
10891059|NCT00520572|EG004|Reported Event|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
10891060|NCT00520572|EG005|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
10891061|NCT00520676|BG000|Baseline|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
10891062|NCT00520676|BG001|Baseline|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
10891063|NCT00520676|BG002|Baseline|Total|Total of all reporting groups
10891064|NCT00520676|FG000|Participant Flow|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
10891065|NCT00520676|FG001|Participant Flow|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
10891066|NCT00520676|OG000|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
10891067|NCT00520676|OG001|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
10891068|NCT00520676|EG000|Reported Event|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
10891069|NCT00520676|EG001|Reported Event|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
10891070|NCT00520741|BG000|Baseline|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
10891071|NCT00520741|BG001|Baseline|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
10891072|NCT00520741|BG002|Baseline|Total|Total of all reporting groups
10891073|NCT00520741|FG000|Participant Flow|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
11171135|NCT02000921|BG001|Baseline|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
10891074|NCT00520741|FG001|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
10891075|NCT00520741|OG000|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
10891076|NCT00520741|OG001|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
10891077|NCT00520741|OG001|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
10891078|NCT00520741|OG001|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3 :1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
10891079|NCT00520741|EG000|Reported Event|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
11171136|NCT02000921|BG002|Baseline|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
10891080|NCT00520741|EG001|Reported Event|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
10891081|NCT00520845|BG000|Baseline|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
10891082|NCT00520845|FG000|Participant Flow|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
11171137|NCT02000921|BG003|Baseline|Total|Total of all reporting groups
11090137|NCT01527045|BG002|Baseline|Adjunct|"NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
11090138|NCT01527045|BG003|Baseline|Total|Total of all reporting groups
10849824|NCT00298389|FG000|Participant Flow|Non Smokers|Non smokers included no history of respiratory or allergic disease, normal baseline spirometry
10849825|NCT00298389|FG001|Participant Flow|Smokers|Smoking history of at least 10 pack years
10849826|NCT00298389|FG002|Participant Flow|COPD|Patients with stable COPD
10849827|NCT00298389|OG000|Outcome|Non Smokers|Non smokers included no history of respiratory or allergic disease, normal baseline spirometry
10849828|NCT00298389|OG001|Outcome|Smokers|Smoking history of at least 10 pack years
10849829|NCT00298389|OG002|Outcome|COPD|Patients with stable COPD
10849830|NCT00298389|EG000|Reported Event|Non Smokers|Non smokers included no history of respiratory or allergic disease, normal baseline spirometry
10849831|NCT00298389|EG001|Reported Event|Smokers|Smoking history of at least 10 pack years
10849832|NCT00298389|EG002|Reported Event|COPD|Patients with stable COPD
10849833|NCT00298558|BG000|Baseline|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
10849834|NCT00298558|BG001|Baseline|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
10849835|NCT00298558|BG002|Baseline|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
10849836|NCT00298558|BG003|Baseline|Control|This group did not complete any cognitive training interventions
10849837|NCT00298558|BG004|Baseline|Total|Total of all reporting groups
10849838|NCT00298558|FG000|Participant Flow|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
10849839|NCT00298558|FG001|Participant Flow|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
10849840|NCT00298558|FG002|Participant Flow|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
10849841|NCT00298558|FG003|Participant Flow|Control|This group did not complete any cognitive training interventions
10849842|NCT00298558|OG000|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
10849843|NCT00298558|OG001|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
10849844|NCT00298558|OG002|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
10849845|NCT00298558|OG003|Outcome|Control|This group did not complete any cognitive training interventions
10849846|NCT00298558|EG000|Reported Event|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
10849847|NCT00298558|EG001|Reported Event|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
10849848|NCT00298558|EG002|Reported Event|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
10849849|NCT00298558|EG003|Reported Event|Control|This group did not complete any cognitive training interventions
10849850|NCT00298610|BG000|Baseline|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
10849851|NCT00298610|FG000|Participant Flow|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
10849852|NCT00298610|OG000|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
10849853|NCT00298610|EG000|Reported Event|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
10891083|NCT00520845|OG000|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
10891084|NCT00520845|EG000|Reported Event|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
10891085|NCT00520884|BG000|Baseline|Healthy|Receiving Placebo at one visit/Ghrelin at other visit
10891086|NCT00520884|BG001|Baseline|Frail|Receiving Placebo at one visit/Ghrelin at other visit
10891087|NCT00520884|BG002|Baseline|Total|Total of all reporting groups
10891088|NCT00520884|FG000|Participant Flow|Healthy Participants, Ghrelin First, Then Saline|Healthy participants, ghrelin first, then saline
10891089|NCT00520884|FG001|Participant Flow|Healthy Participants, Saline First, Then Ghrelin|Healthy participants, saline first, then ghrelin
10891090|NCT00520884|FG002|Participant Flow|Frail Participants, Ghrelin First, Then Saline|Frail participants, ghrelin first, then saline
10891091|NCT00520884|FG003|Participant Flow|Frail Participants, Saline First, Then Ghrelin|Frail participants, saline first, then ghrelin
10891092|NCT00520884|OG000|Outcome|Saline Infusion|Saline infusion in combined healthy and frail groups
10891093|NCT00520884|OG001|Outcome|Ghrelin Infusion|Saline infusion in combined healthy and frail groups
10891094|NCT00520884|OG001|Outcome|Ghrelin Infusion|Ghrelin infusion in combined healthy and frail groups
11090139|NCT01527045|FG000|Participant Flow|Primary - Reg A (Flu/TBI)|"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0.~TRANSPLANT: Patients undergo donor PBSC transplant on day 0.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
10891095|NCT00520884|EG000|Reported Event|Placebo|Healthy and frail participants had a study visit in which they received placebo (saline) infusion
10891096|NCT00520884|EG001|Reported Event|Ghrelin|Healthy and frail participants had a study visit in which they received ghrelin infusion
10891097|NCT00520910|BG000|Baseline|Polypodium Leucotomos Extract|"Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.~Polypodium leucotomos: Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2."
10891098|NCT00520910|BG001|Baseline|No Intervention|Subject is not given any treatment.
10891099|NCT00520910|BG002|Baseline|Total|Total of all reporting groups
10891100|NCT00520910|FG000|Participant Flow|Polypodium Leucotomos Extract|"Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.~Polypodium leucotomos: Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2."
10891101|NCT00520910|FG001|Participant Flow|No Intervention|Subject is not given any treatment.
10891102|NCT00520910|OG000|Outcome|Polypodium Leucotomos Extract|"Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.~Polypodium leucotomos: Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2."
10891103|NCT00520910|OG001|Outcome|No Intervention|Subject is not given any treatment.
10891104|NCT00520910|EG000|Reported Event|Polypodium Leucotomos Extract|"Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.~Polypodium leucotomos: Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2."
10891105|NCT00520910|EG001|Reported Event|No Intervention|Subject is not given any treatment.
10891106|NCT00520936|BG000|Baseline|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
10891107|NCT00520936|BG001|Baseline|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891108|NCT00520936|BG002|Baseline|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891109|NCT00520936|BG003|Baseline|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891110|NCT00520936|BG004|Baseline|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891111|NCT00520936|BG005|Baseline|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891112|NCT00520936|BG006|Baseline|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891113|NCT00520936|BG007|Baseline|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891114|NCT00520936|BG008|Baseline|Total|Total of all reporting groups
10891115|NCT00520936|FG000|Participant Flow|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
10891116|NCT00520936|FG001|Participant Flow|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891117|NCT00520936|FG002|Participant Flow|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891118|NCT00520936|FG003|Participant Flow|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891119|NCT00520936|FG004|Participant Flow|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891120|NCT00520936|FG005|Participant Flow|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891121|NCT00520936|FG006|Participant Flow|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891122|NCT00520936|FG007|Participant Flow|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891123|NCT00520936|OG000|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
10891124|NCT00520936|OG001|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891125|NCT00520936|OG002|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891126|NCT00520936|OG003|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891127|NCT00520936|OG004|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891128|NCT00520936|OG005|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891129|NCT00520936|OG006|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891130|NCT00520936|OG007|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
10891131|NCT00520936|EG000|Reported Event|Pemetrexed|Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient <12 months old)
10891132|NCT00520975|BG000|Baseline|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
10891133|NCT00520975|BG001|Baseline|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
10891134|NCT00520975|BG002|Baseline|Total|Total of all reporting groups
10891135|NCT00520975|FG000|Participant Flow|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
10891136|NCT00520975|FG001|Participant Flow|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
10891137|NCT00520975|OG000|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
10891138|NCT00520975|OG001|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
10914742|NCT00632749|BG002|Baseline|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11233196|NCT02424734|OG000|Outcome|Ceftaroline Fosamil: All Participants|All participants who received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10891139|NCT00520975|EG000|Reported Event|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
10891140|NCT00520975|EG001|Reported Event|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
10891141|NCT00521001|BG000|Baseline|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10891142|NCT00521001|FG000|Participant Flow|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10891143|NCT00521001|OG000|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10891144|NCT00521001|EG000|Reported Event|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10891145|NCT00521014|BG000|Baseline|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
10891146|NCT00521014|FG000|Participant Flow|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF
10891147|NCT00521014|OG000|Outcome|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
10891148|NCT00521014|EG000|Reported Event|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
10891149|NCT00521053|BG000|Baseline|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
10891150|NCT00521053|FG000|Participant Flow|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation. In the treatment phase, participants received a single IL injection of PV-10 into each of up to 20 study lesions on day 0 (i.e., one cycle). Treatment cycles could be repeated at weeks 8, 12 and 16 for new non-target lesions or existing target or non-target lesions not exhibiting complete response (i.e., complete disappearance). Participants were observed for 52 weeks. Radiologic assessments of visceral disease status were performed every 12 weeks throughout the study and patients were transitioned into survival follow-up if at any time the investigator identified clinical or radiologic evidence of distant progression. No other melanoma therapy was permitted during the study interval.
10891151|NCT00521053|OG000|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
10891152|NCT00521053|OG000|Outcome|Stage III|Participants reporting Stage III disease at baseline
10891153|NCT00521053|OG001|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
10891154|NCT00521053|OG000|Outcome|All Lesions Treated|
10891155|NCT00521053|EG000|Reported Event|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
10891156|NCT00521079|BG000|Baseline|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
10891157|NCT00521079|BG001|Baseline|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
10891158|NCT00521079|BG002|Baseline|Total|Total of all reporting groups
10891159|NCT00521079|FG000|Participant Flow|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
10891160|NCT00521079|FG001|Participant Flow|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
10891161|NCT00521079|OG000|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
10891162|NCT00521079|OG001|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
10891163|NCT00521079|EG000|Reported Event|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
10891164|NCT00521079|EG001|Reported Event|Placebo|Subjects implanted with a functional Maestro System device that does NOT delivers therapy (Therapy OFF).
10891165|NCT00521144|BG000|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 1|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891166|NCT00521144|BG001|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 2|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891167|NCT00521144|BG002|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 3|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891168|NCT00521144|BG003|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 4|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891169|NCT00521144|BG004|Baseline|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
10891170|NCT00521144|BG005|Baseline|Total|Total of all reporting groups
10891171|NCT00521144|FG000|Participant Flow|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891172|NCT00521144|FG001|Participant Flow|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891173|NCT00521144|FG002|Participant Flow|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891174|NCT00521144|FG003|Participant Flow|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891175|NCT00521144|FG004|Participant Flow|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
10891176|NCT00521144|OG000|Outcome|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891177|NCT00521144|OG001|Outcome|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
11090140|NCT01527045|FG001|Participant Flow|Primary - Reg B (TBI Alone)|"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0.~TRANSPLANT: Patients undergo donor PBSC transplant on day 0.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
10891178|NCT00521144|OG002|Outcome|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891179|NCT00521144|OG003|Outcome|Phase 1; Level 4: Obatoclax Mesylate + Topotecan|Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891180|NCT00521144|OG004|Outcome|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
10891181|NCT00521144|EG000|Reported Event|Phase I; Level 1: Obatoclax Mesylate + Topotecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891182|NCT00521144|EG001|Reported Event|Phase I; Level 2: Obatoclax Mesylate + Topotecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891183|NCT00521144|EG002|Reported Event|Phase I; Level 3: Obatoclax Mesylate + Topotecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891184|NCT00521144|EG003|Reported Event|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
10891185|NCT00521144|EG004|Reported Event|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
10891186|NCT00521339|BG000|Baseline|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
10891187|NCT00521339|FG000|Participant Flow|Apremilast 20mg|Participants received 20mg Apremilast capsules by mouth (PO) twice a day (BID) on Days 1 through 85 during the Treatment Phase
10891188|NCT00521339|FG001|Participant Flow|Apremilast 20mg/20mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
10891189|NCT00521339|FG002|Participant Flow|Apremilast 20mg/30mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
10891190|NCT00521339|OG000|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the Treatment Phase
10891191|NCT00521339|OG000|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
10891192|NCT00521339|OG000|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
10891193|NCT00521339|OG000|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the treatment phase
10891194|NCT00521339|OG000|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
10891195|NCT00521339|OG000|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
10891196|NCT00521339|OG000|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
10891197|NCT00521339|OG000|Outcome|Apremilast 20mg PO BID|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
10891198|NCT00521339|OG000|Outcome|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
10891199|NCT00521339|OG001|Outcome|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
10891200|NCT00521339|OG000|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
10891201|NCT00521339|OG000|Outcome|Apremilast 20/30mg BID|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
10891202|NCT00521339|OG000|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
10891203|NCT00521339|OG000|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
10891204|NCT00521339|OG000|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
10891205|NCT00521339|OG000|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
10891206|NCT00521339|EG000|Reported Event|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
10891207|NCT00521339|EG001|Reported Event|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
10891208|NCT00521339|EG002|Reported Event|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
10891209|NCT00521352|BG000|Baseline|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
10891210|NCT00521352|BG001|Baseline|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
10891211|NCT00521352|BG002|Baseline|Total|Total of all reporting groups
10891212|NCT00521352|FG000|Participant Flow|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
10891213|NCT00521352|FG001|Participant Flow|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
10891214|NCT00521352|OG000|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
10891215|NCT00521352|OG001|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
10891216|NCT00521352|EG000|Reported Event|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
10891217|NCT00521352|EG001|Reported Event|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
10891218|NCT00521365|BG000|Baseline|Quetiapine 600 mg|Quetiapine Extended release 600 mg per day either as monotherapy or combined therapy
10891219|NCT00521365|FG000|Participant Flow|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
10891220|NCT00521365|OG000|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
10849854|NCT00298766|BG000|Baseline|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
10849855|NCT00298766|FG000|Participant Flow|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
10849856|NCT00298766|OG000|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
10849857|NCT00298766|EG000|Reported Event|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
10849858|NCT00298831|BG000|Baseline|Sugammadex|Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
10849859|NCT00298831|FG000|Participant Flow|Sugammadex|Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
10849860|NCT00298831|OG000|Outcome|Sugammadex|Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
10849861|NCT00298831|EG000|Reported Event|Sugammadex|Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
10849862|NCT00298896|BG000|Baseline|SNS-595|SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
10849863|NCT00298896|FG000|Participant Flow|SNS-595|SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
10849864|NCT00298896|OG000|Outcome|SNS-595|SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
10849865|NCT00298896|EG000|Reported Event|SNS-595|"SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.~SNS-595"
10849866|NCT00299000|BG000|Baseline|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
10849867|NCT00299000|BG001|Baseline|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
10849868|NCT00299000|BG002|Baseline|Total|Total of all reporting groups
10849869|NCT00299000|FG000|Participant Flow|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
10849870|NCT00299000|FG001|Participant Flow|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
10849871|NCT00299000|OG000|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
10849872|NCT00299000|OG001|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
10849873|NCT00299000|EG000|Reported Event|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
10849874|NCT00299000|EG001|Reported Event|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
10849875|NCT00299104|BG000|Baseline|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
10849876|NCT00299104|BG001|Baseline|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
10849877|NCT00299104|BG002|Baseline|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
10849878|NCT00299104|BG003|Baseline|Total|Total of all reporting groups
10849879|NCT00299104|FG000|Participant Flow|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
10849880|NCT00299104|FG001|Participant Flow|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
10849881|NCT00299104|FG002|Participant Flow|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
10891221|NCT00521365|EG000|Reported Event|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
10891222|NCT00521404|BG000|Baseline|CS-1008 + Gemcitabine|Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
10891223|NCT00521404|FG000|Participant Flow|CS-1008 + Gemcitabine|Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
10891224|NCT00521404|OG000|Outcome|CS-1008 + Gemcitabine|Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
11171138|NCT02000921|FG000|Participant Flow|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
11171139|NCT02000921|FG001|Participant Flow|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
11171140|NCT02000921|FG002|Participant Flow|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
11171141|NCT02000921|OG000|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
11171142|NCT02000921|OG001|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
11171143|NCT02000921|OG002|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
11171144|NCT02000921|EG000|Reported Event|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
11171145|NCT02000921|EG001|Reported Event|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
11171146|NCT02000921|EG002|Reported Event|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
11171147|NCT02000973|BG000|Baseline|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
11171148|NCT02000973|BG001|Baseline|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
11171149|NCT02000973|BG002|Baseline|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
10891225|NCT00521404|EG000|Reported Event|CS-1008 + Gemcitabine|Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
10891226|NCT00521456|BG000|Baseline|Ketorolac Solution|
10891227|NCT00521456|BG001|Baseline|Vehicle Solution|
10891228|NCT00521456|BG002|Baseline|Total|Total of all reporting groups
10891229|NCT00521456|FG000|Participant Flow|Ketorolac Solution|
10891230|NCT00521456|FG001|Participant Flow|Vehicle Solution|
10891231|NCT00521456|OG000|Outcome|Ketorolac Solution|
10891232|NCT00521456|OG001|Outcome|Vehicle Solution|
10891233|NCT00521456|EG000|Reported Event|Ketorolac Solution|
10891234|NCT00521456|EG001|Reported Event|Vehicle Solution|
10891235|NCT00521586|BG000|Baseline|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
10891236|NCT00521586|BG001|Baseline|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
10891237|NCT00521586|BG002|Baseline|Total|Total of all reporting groups
10891238|NCT00521586|FG000|Participant Flow|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
10891239|NCT00521586|FG001|Participant Flow|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
10891240|NCT00521586|OG000|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
10891241|NCT00521586|OG001|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
10891242|NCT00521586|OG000|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
11171150|NCT02000973|BG003|Baseline|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
11171151|NCT02000973|BG004|Baseline|Total|Total of all reporting groups
10891243|NCT00521586|OG000|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
10891244|NCT00521586|EG000|Reported Event|13vPnC+TIV/Placebo: Dose 1 (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
10891245|NCT00521586|EG001|Reported Event|13vPnC+TIV/Placebo: Dose 2 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
10891246|NCT00521586|EG002|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
10891247|NCT00521586|EG003|Reported Event|13vPnC+TIV/Placebo: Years 1-4|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
10891248|NCT00521586|EG004|Reported Event|13vPnC+TIV/Placebo: 13vPnC (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
10891249|NCT00521586|EG005|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
10891250|NCT00521586|EG006|Reported Event|Placebo+TIV/13vPnC: Dose 1 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
10891251|NCT00521586|EG007|Reported Event|Placebo+TIV/13vPnC: Dose 2 (Year 0)|Participants who received 0.5-mL dose of 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
10891252|NCT00521586|EG008|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
10891253|NCT00521586|EG009|Reported Event|Placebo+TIV/13vPnC: Years 1-4|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
10891254|NCT00521586|EG010|Reported Event|Placebo+TIV/13vPnC: 13vPnC (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
10891255|NCT00521586|EG011|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
10891256|NCT00521976|BG000|Baseline|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
11090141|NCT01527045|FG002|Participant Flow|Adjunct|"NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
11171152|NCT02000973|FG000|Participant Flow|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
10891257|NCT00521976|FG000|Participant Flow|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
10891258|NCT00521976|OG000|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
10891259|NCT00521976|EG000|Reported Event|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
10891260|NCT00521989|BG000|Baseline|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
10891261|NCT00521989|BG001|Baseline|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
10891262|NCT00521989|BG002|Baseline|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
10891263|NCT00521989|BG003|Baseline|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
10891264|NCT00521989|BG004|Baseline|Placebo|"Placebo~Placebo: Placebo"
10891265|NCT00521989|BG005|Baseline|Total|Total of all reporting groups
10891266|NCT00521989|FG000|Participant Flow|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
11171153|NCT02000973|FG001|Participant Flow|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
11171154|NCT02000973|FG002|Participant Flow|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
11171155|NCT02000973|FG003|Participant Flow|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
11171156|NCT02000973|OG000|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
11171157|NCT02000973|OG001|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
10891267|NCT00521989|FG001|Participant Flow|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
10891268|NCT00521989|FG002|Participant Flow|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
10891269|NCT00521989|FG003|Participant Flow|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
10891270|NCT00521989|FG004|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
10891271|NCT00521989|OG000|Outcome|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
10891272|NCT00521989|OG001|Outcome|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
10891273|NCT00521989|OG002|Outcome|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
10891274|NCT00521989|OG003|Outcome|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
10891275|NCT00521989|OG004|Outcome|Placebo|"Placebo~Placebo: Placebo"
10891276|NCT00521989|EG000|Reported Event|Placebo|Placebo
10891277|NCT00521989|EG001|Reported Event|Prednisolone|Prednisolone 2.7 mg
10891278|NCT00521989|EG002|Reported Event|CRx-102 (2.7/90 mg)|CRx-102 dose 1 (2.7 mg prednisolone + 90 mg dipyridamole)
10891279|NCT00521989|EG003|Reported Event|CRx-102 (2.7/180 mg)|CRx-102 dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
10891280|NCT00521989|EG004|Reported Event|CRx-102 (2.7/360 mg)|CRx-102 dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
11090142|NCT01527045|OG000|Outcome|Primary - Reg A (Flu/TBI)|"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0.~TRANSPLANT: Patients undergo donor PBSC transplant on day 0.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
10891281|NCT00522041|BG000|Baseline|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891282|NCT00522041|BG001|Baseline|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891283|NCT00522041|BG002|Baseline|Total|Total of all reporting groups
11090143|NCT01527045|OG001|Outcome|Primary - Reg B (TBI Alone)|"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0.~TRANSPLANT: Patients undergo donor PBSC transplant on day 0.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
11090144|NCT01527045|OG002|Outcome|Adjunct|"NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
11090145|NCT01527045|EG000|Reported Event|Primary - Reg A (Flu/TBI)|"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0.~TRANSPLANT: Patients undergo donor PBSC transplant on day 0.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
11171158|NCT02000973|OG002|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
11171159|NCT02000973|OG003|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
10891284|NCT00522041|FG000|Participant Flow|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891285|NCT00522041|FG001|Participant Flow|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891286|NCT00522041|OG000|Outcome|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891287|NCT00522041|OG001|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891288|NCT00522041|OG000|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891289|NCT00522041|EG000|Reported Event|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891290|NCT00522041|EG001|Reported Event|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
10891291|NCT00522171|BG000|Baseline|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
10914743|NCT00632749|BG003|Baseline|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11171160|NCT02000973|EG000|Reported Event|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
11171161|NCT02000973|EG001|Reported Event|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
11171162|NCT02000973|EG002|Reported Event|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
11171163|NCT02000973|EG003|Reported Event|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
11171164|NCT02001051|BG000|Baseline|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
11171165|NCT02001051|BG001|Baseline|Delayed Operative Arm Followed by Surgery|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
11090146|NCT01527045|EG001|Reported Event|Primary - Reg B (TBI Alone)|"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0.~TRANSPLANT: Patients undergo donor PBSC transplant on day 0.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
11090147|NCT01527045|EG002|Reported Event|Adjunct|"NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan.~POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27."
11090148|NCT01527110|BG000|Baseline|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
11171166|NCT02001051|BG002|Baseline|Total|Total of all reporting groups
11171167|NCT02001051|FG000|Participant Flow|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
11171168|NCT02001051|FG001|Participant Flow|Delayed Operative Arm Followed by Surgery|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
11171169|NCT02001051|OG000|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
11171170|NCT02001051|OG001|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
11171171|NCT02001051|EG000|Reported Event|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
10891292|NCT00522171|BG001|Baseline|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
10891293|NCT00522171|BG002|Baseline|Total|Total of all reporting groups
10891294|NCT00522171|FG000|Participant Flow|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
10891295|NCT00522171|FG001|Participant Flow|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
10891296|NCT00522171|OG000|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
10891297|NCT00522171|OG001|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
10891298|NCT00522171|EG000|Reported Event|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
10891299|NCT00522171|EG001|Reported Event|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
10891300|NCT00522275|BG000|Baseline|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
10891301|NCT00522275|FG000|Participant Flow|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
10891302|NCT00522275|OG000|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
10891303|NCT00522275|EG000|Reported Event|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
10891304|NCT00522379|BG000|Baseline|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
10891305|NCT00522379|BG001|Baseline|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
11171172|NCT02001051|EG001|Reported Event|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
11171173|NCT02001064|BG000|Baseline|Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence|"Care4Today v2.0 mobile application~Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.~Electronic monitoring of adherence:~Participants' adherence to antiretroviral therapy medication is measured via MEMS cap."
11171174|NCT02001064|BG001|Baseline|Electronic Monitoring of Adherence|"Electronic monitoring of adherence:~Participants' adherence to antiretroviral therapy medication is measured via MEMS cap."
11171175|NCT02001064|BG002|Baseline|Total|Total of all reporting groups
11171176|NCT02001064|FG000|Participant Flow|Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence|"Care4Today v2.0 mobile application~Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.~Electronic monitoring of adherence:~Participants' adherence to antiretroviral therapy medication is measured via MEMS cap."
11171177|NCT02001064|FG001|Participant Flow|Electronic Monitoring of Adherence|"Electronic monitoring of adherence:~Participants' adherence to antiretroviral therapy medication is measured via MEMS cap."
10891306|NCT00522379|BG002|Baseline|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
10891307|NCT00522379|BG003|Baseline|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
10891308|NCT00522379|BG004|Baseline|Placebo|
10891309|NCT00522379|BG005|Baseline|Total|Total of all reporting groups
10891310|NCT00522379|FG000|Participant Flow|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
10891311|NCT00522379|FG001|Participant Flow|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
10891312|NCT00522379|FG002|Participant Flow|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
10891313|NCT00522379|FG003|Participant Flow|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
10891314|NCT00522379|FG004|Participant Flow|Placebo|
10891315|NCT00522379|OG000|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
10891316|NCT00522379|OG001|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
10891317|NCT00522379|OG002|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
10891318|NCT00522379|OG003|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
10891319|NCT00522379|OG004|Outcome|Placebo|
10891320|NCT00522379|EG000|Reported Event|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
10891321|NCT00522379|EG001|Reported Event|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
10891322|NCT00522379|EG002|Reported Event|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
10891323|NCT00522379|EG003|Reported Event|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
10891324|NCT00522379|EG004|Reported Event|Placebo|
10891325|NCT00522392|BG000|Baseline|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
10891326|NCT00522392|BG001|Baseline|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
10891327|NCT00522392|BG002|Baseline|Total|Total of all reporting groups
10891328|NCT00522392|FG000|Participant Flow|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
10891329|NCT00522392|FG001|Participant Flow|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
10891330|NCT00522392|OG000|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
10891331|NCT00522392|OG001|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
10891332|NCT00522392|EG000|Reported Event|Arm A (VRd Regimen)|Arm A (VRd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
10891333|NCT00522392|EG001|Reported Event|Arm B (Vd Regimen)|Arm B (Vd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
10891334|NCT00522418|BG000|Baseline|VNS Therapy|VNS Therapy + Best Medical Practice
10891335|NCT00522418|BG001|Baseline|Best Medical Practice|Best Medical Practice Without VNS Therapy
10891336|NCT00522418|BG002|Baseline|Total|Total of all reporting groups
10849882|NCT00299104|OG000|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
10891337|NCT00522418|FG000|Participant Flow|VNS Therapy|VNS Therapy + Best Medical Practice
10891338|NCT00522418|FG001|Participant Flow|Best Medical Practice|Best Medical Practice Without VNS Therapy
10891339|NCT00522418|OG000|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
10891340|NCT00522418|OG001|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
10891341|NCT00522418|OG000|Outcome|Baseline Adverse Event Profile Score >= 40|Population with Baseline Adverse Event Profile Score >= 40
10891342|NCT00522418|OG000|Outcome|Baseline Adverse Event Profile Score < 40|Population with Baseline Adverse Event Profile Score < 40
10891343|NCT00522418|EG000|Reported Event|VNS Therapy|VNS Therapy + Best Medical Practice
10891344|NCT00522418|EG001|Reported Event|Best Medical Practice|Best Medical Practice Without VNS Therapy
10891345|NCT00522431|BG000|Baseline|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
10891346|NCT00522431|FG000|Participant Flow|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
10891347|NCT00522431|OG000|Outcome|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
10891348|NCT00522431|EG000|Reported Event|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
10891349|NCT00522548|BG000|Baseline|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
10891350|NCT00522548|BG001|Baseline|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
10891351|NCT00522548|BG002|Baseline|Total|Total of all reporting groups
10891352|NCT00522548|FG000|Participant Flow|Myfortic Comparator Group|Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) 180 mg tablets administered as 720mg (4 tablets) orally twice daily (adjusted for side effects as needed) in addition to immunosuppressants: Thymoglobulin (Rabbit antithymocyte globulin), Prograf (tacrolimus) or its generic equivalanet and corticosteroids.
10891353|NCT00522548|FG001|Participant Flow|CellCept Comparator Group|Patients in this group will receive CellCept (mycophenolate mofetil) 250mg capsules administered as 1000mg (4 capsules) orally twice daily (adjusted for side effects as needed) in addition to immunosuppressants: Thymoglobulin (rabbit anti-thymocyte globulin) Prograf (tacrolimus) or its generic equivalent and corticosteroids.
10891354|NCT00522548|OG000|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
10891355|NCT00522548|OG001|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
10891356|NCT00522548|EG000|Reported Event|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
10891357|NCT00522548|EG001|Reported Event|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
10891358|NCT00522626|BG000|Baseline|Observational|Opioid exposed pregnancies
10891359|NCT00522626|FG000|Participant Flow|Observational|Opioid exposed pregnancies
10891360|NCT00522626|OG000|Outcome|Trough Fetal Heart Rate|Opioid exposed pregnancies
10891361|NCT00522626|EG000|Reported Event|Observational|Opioid exposed pregnancies
10891362|NCT00522795|BG000|Baseline|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
10891363|NCT00522795|FG000|Participant Flow|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
10891364|NCT00522795|OG000|Outcome|PPX, Cisplatin, Radiation|
11171178|NCT02001064|OG000|Outcome|Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence|"Care4Today v2.0 mobile application~Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.~Electronic monitoring of adherence:~Participants' adherence to antiretroviral therapy medication is measured via MEMS cap."
10891365|NCT00522795|EG000|Reported Event|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
10891366|NCT00522873|BG000|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
10891367|NCT00522873|BG001|Baseline|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
10891368|NCT00522873|BG002|Baseline|Total|Total of all reporting groups
10891369|NCT00522873|FG000|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
10891370|NCT00522873|FG001|Participant Flow|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
10891371|NCT00522873|OG000|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
10891372|NCT00522873|OG001|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
10891373|NCT00522873|EG000|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
10891374|NCT00522873|EG001|Reported Event|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
10891375|NCT00522925|BG000|Baseline|1- Placebo|Placebo
10891376|NCT00522925|BG001|Baseline|2- PS433540 200mg|200mg daily for 4 weeks
10891377|NCT00522925|BG002|Baseline|3- PS433540 500mg|500mg once daily for 4 weeks
10891378|NCT00522925|BG003|Baseline|Total|Total of all reporting groups
10891379|NCT00522925|FG000|Participant Flow|1- Placebo|Placebo
10891380|NCT00522925|FG001|Participant Flow|2- PS433540 200mg|200mg daily for 4 weeks
10891381|NCT00522925|FG002|Participant Flow|3- PS433540 500mg|500mg once daily for 4 weeks
10891382|NCT00522925|OG000|Outcome|1- Placebo|Placebo
10891383|NCT00522925|OG001|Outcome|2- PS433540 200mg|200mg daily for 4 weeks
10891384|NCT00522925|OG002|Outcome|3- PS433540 500mg|500mg once daily for 4 weeks
10891385|NCT00522925|EG000|Reported Event|1- Placebo|Placebo
10891386|NCT00522925|EG001|Reported Event|2- PS433540 200mg|200mg daily for 4 weeks
10891387|NCT00522925|EG002|Reported Event|3- PS433540 500mg|500mg once daily for 4 weeks
10891388|NCT00522951|BG000|Baseline|Entire Study Population|includes all participants received treatment
10891389|NCT00522951|FG000|Participant Flow|Gadobutrol Then Gadoteridol|Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2
10891390|NCT00522951|FG001|Participant Flow|Gadoteridol Then Gadobutrol|Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2
10891391|NCT00522951|OG000|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
10891392|NCT00522951|OG001|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
10891393|NCT00522951|OG002|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
10891394|NCT00522951|OG000|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
10891395|NCT00522951|OG000|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
10891396|NCT00522951|OG001|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
10891397|NCT00522951|EG000|Reported Event|Gadobutrol Period|Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
10891398|NCT00522951|EG001|Reported Event|ProHance Period|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
10891399|NCT00523237|BG000|Baseline|Raltegravir|400 mg twice daily
10891400|NCT00523237|FG000|Participant Flow|Raltegravir|400 mg twice daily
10891401|NCT00523237|OG000|Outcome|Enfuvirtide Switch to Raltegravir Arm|patients were switched from Enfuvirtide to Raltegravir
10891402|NCT00523237|EG000|Reported Event|Raltegravir|400 mg twice daily
10891403|NCT00523302|BG000|Baseline|Active TMS|"Participants receive 5 Active TMS treatment sessions per week for two weeks. Active stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.~Active TMS: Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days."
10891404|NCT00523302|BG001|Baseline|Sham TMS|"Participants receive 5 Sham TMS treatment sessions per week for two weeks. Sham stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week=20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.~Sham TMS: Sham TMS will use the same stimulation frequency for all active subjects (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines."
10891405|NCT00523302|BG002|Baseline|Total|Total of all reporting groups
10891406|NCT00523302|FG000|Participant Flow|Active TMS|"Participants receive 5 Active TMS treatment sessions per week for two weeks. Active stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.~Active TMS: Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days."
11171179|NCT02001064|OG001|Outcome|Electronic Monitoring of Adherence|"Electronic monitoring of adherence:~Participants' adherence to antiretroviral therapy medication is measured via MEMS cap."
11171180|NCT02001064|EG000|Reported Event|Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence|"Care4Today v2.0 mobile application~Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.~Electronic monitoring of adherence:~Participants' adherence to antiretroviral therapy medication is measured via MEMS cap."
10914744|NCT00632749|BG004|Baseline|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11233197|NCT02424734|EG000|Reported Event|Ceftaroline Fosamil: Young Infants|Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
11171181|NCT02001064|EG001|Reported Event|Electronic Monitoring of Adherence|"Electronic monitoring of adherence:~Participants' adherence to antiretroviral therapy medication is measured via MEMS cap."
11171182|NCT02001181|BG000|Baseline|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
11171183|NCT02001181|BG001|Baseline|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
11171184|NCT02001181|BG002|Baseline|Total|Total of all reporting groups
10891407|NCT00523302|FG001|Participant Flow|Sham TMS|"Participants receive 5 Sham TMS treatment sessions per week for two weeks. Sham stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week=20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.~Sham TMS: Sham TMS will use the same stimulation frequency for all active subjects (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines."
10891408|NCT00523302|OG000|Outcome|Active TMS|Since cortical stimulation can be performed non-invasively by active Transcranial Magnetic Stimulation (TMS), Participants in the active TMS group, receive five 20 minute active TMS treatment sessions per week for two weeks. Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.
10891409|NCT00523302|OG001|Outcome|Sham TMS|To prevent unwanted cortical activation, Sham TMS will be employed in the Sham TMS group. For the Sham TMS group, a specially designed sham TMS coil will be used for all sham conditions. This sham TMS coil produces auditory signals identical to active TMS coils but is shielded so that actual stimulation does not occur. This approach is currently the state-of-the-art approach to sham TMS procedures and is employed in high-quality clinical TMS trials. Participants in the sham TMS group receive five 20 minute Sham TMS treatment sessions per week for two weeks.
10891410|NCT00523302|EG000|Reported Event|Active TMS|"Participants receive 5 Active TMS treatment sessions per week for two weeks. Active stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.~Active TMS: Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days."
10891411|NCT00523302|EG001|Reported Event|Sham TMS|"Participants receive 5 Sham TMS treatment sessions per week for two weeks. Sham stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week=20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.~Sham TMS: Sham TMS will use the same stimulation frequency for all active subjects (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines."
10891412|NCT00523341|BG000|Baseline|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
10891413|NCT00523341|BG001|Baseline|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
10891414|NCT00523341|BG002|Baseline|Total|Total of all reporting groups
10891415|NCT00523341|FG000|Participant Flow|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
10891416|NCT00523341|FG001|Participant Flow|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
10891417|NCT00523341|OG000|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
10891418|NCT00523341|OG001|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
10891419|NCT00523341|EG000|Reported Event|Placebo/ Denosumab 60 mg Q6M|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years.
10891420|NCT00523341|EG001|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years (total of 10 years treatment).
10891421|NCT00523367|BG000|Baseline|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
10891422|NCT00523367|FG000|Participant Flow|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
11171185|NCT02001181|FG000|Participant Flow|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
11171186|NCT02001181|FG001|Participant Flow|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
11171187|NCT02001181|OG000|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
11171188|NCT02001181|OG001|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
11171189|NCT02001181|EG000|Reported Event|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
11171190|NCT02001181|EG001|Reported Event|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
11171191|NCT02001194|BG000|Baseline|Control|Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
10891423|NCT00523367|OG000|Outcome|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
10891424|NCT00523367|EG000|Reported Event|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
10891425|NCT00523419|BG000|Baseline|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
10891426|NCT00523419|FG000|Participant Flow|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
10891427|NCT00523419|OG000|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
10891428|NCT00523419|EG000|Reported Event|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
11171192|NCT02001194|BG001|Baseline|Individual|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.~Individual Incentives"
11233198|NCT02424734|EG001|Reported Event|Ceftaroline Fosamil: Term Neonates|Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10891429|NCT00523549|BG000|Baseline|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
10891430|NCT00523549|BG001|Baseline|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
10891431|NCT00523549|BG002|Baseline|Total|Total of all reporting groups
10914745|NCT00632749|BG005|Baseline|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11171193|NCT02001194|BG002|Baseline|Team|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.~Team Incentives"
11171194|NCT02001194|BG003|Baseline|Individual Plus Team|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.~Individual plus Team Incentives"
11171195|NCT02001194|BG004|Baseline|Total|Total of all reporting groups
11171196|NCT02001194|FG000|Participant Flow|Control|Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
11171197|NCT02001194|FG001|Participant Flow|Individual|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.~Individual Incentives"
11171198|NCT02001194|FG002|Participant Flow|Team|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.~Team Incentives"
10891432|NCT00523549|FG000|Participant Flow|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
10891433|NCT00523549|FG001|Participant Flow|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
10891434|NCT00523549|OG000|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
10891435|NCT00523549|OG001|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
10891436|NCT00523549|EG000|Reported Event|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
10891437|NCT00523549|EG001|Reported Event|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
10891438|NCT00523614|BG000|Baseline|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
10891439|NCT00523614|BG001|Baseline|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
10891440|NCT00523614|BG002|Baseline|Total|Total of all reporting groups
10891441|NCT00523614|FG000|Participant Flow|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
11233199|NCT02424734|EG002|Reported Event|Ceftaroline Fosamil: Preterm Neonates|Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
10891442|NCT00523614|FG001|Participant Flow|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
10891443|NCT00523614|OG000|Outcome|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
10891444|NCT00523614|OG001|Outcome|Controls|Women without a venous thromboembolism who are between 15 and 49 years old
10891445|NCT00523614|EG000|Reported Event|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
10891446|NCT00523614|EG001|Reported Event|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
10891447|NCT00523640|BG000|Baseline|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
10891448|NCT00523640|FG000|Participant Flow|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
10891449|NCT00523640|OG000|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
10891450|NCT00523640|EG000|Reported Event|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
10891451|NCT00523705|BG000|Baseline|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
10891452|NCT00523705|BG001|Baseline|Sugar Pill|Placebo tablets matched to drug.
10891453|NCT00523705|BG002|Baseline|Total|Total of all reporting groups
10891454|NCT00523705|FG000|Participant Flow|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
10891455|NCT00523705|FG001|Participant Flow|Sugar Pill|Placebo tablets matched to drug.
10891456|NCT00523705|OG000|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
10891457|NCT00523705|OG001|Outcome|Sugar Pill|Placebo tablets matched to drug.
10891458|NCT00523705|EG000|Reported Event|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
10891459|NCT00523705|EG001|Reported Event|Sugar Pill|Placebo tablets matched to drug.
10891460|NCT00523718|BG000|Baseline|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
10891461|NCT00523718|BG001|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
10891462|NCT00523718|BG002|Baseline|Total|Total of all reporting groups
11171199|NCT02001194|FG003|Participant Flow|Individual Plus Team|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.~Individual plus Team Incentives"
11171200|NCT02001194|OG000|Outcome|Control|Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
11171201|NCT02001194|OG001|Outcome|Individual|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.~Individual Incentives"
11171202|NCT02001194|OG002|Outcome|Team|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.~Team Incentives"
10891463|NCT00523718|FG000|Participant Flow|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
10891464|NCT00523718|FG001|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
10891465|NCT00523718|OG000|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
10891466|NCT00523718|OG001|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
10891467|NCT00523718|EG000|Reported Event|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
10891468|NCT00523718|EG001|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
10891469|NCT00523744|BG000|Baseline|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
10891470|NCT00523744|FG000|Participant Flow|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
10891471|NCT00523744|OG000|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
10891472|NCT00523744|OG000|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
10891473|NCT00523744|EG000|Reported Event|Phase 1 - Amlodipine+Olmesartan|4 weeks treatment with amlodipine 10 mg plus olmesartan 20 mg taken orally once daily in the morning.
10891474|NCT00523744|EG001|Reported Event|Phase 2 - Amlodipine+Valsartan|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
10891475|NCT00523744|EG002|Reported Event|Phase 3 - Amlodipine+Valsartan+HCTZ|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
10891476|NCT00523848|BG000|Baseline|VDT: VELCADE, Doxil and Low-dose Thalidomide|
10891477|NCT00523848|FG000|Participant Flow|Arm 1 - VDT: VELCADE, Doxil and Low-dose Thalidomide|Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
10891478|NCT00523848|OG000|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
10891479|NCT00523848|EG000|Reported Event|VDT: VELCADE, Doxil and Low-dose Thalidomide|
10891480|NCT00523978|BG000|Baseline|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
10891481|NCT00523978|BG001|Baseline|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
10891482|NCT00523978|BG002|Baseline|Total|Total of all reporting groups
10891483|NCT00523978|FG000|Participant Flow|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
10891484|NCT00523978|FG001|Participant Flow|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
11233200|NCT02424799|BG000|Baseline|Part A-GSK2646264 0.5% and Placebo|Participants were treated topically with 0.5 % GSK2646264 cream and placebo cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
10891485|NCT00523978|OG000|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
10891486|NCT00523978|OG000|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
10891487|NCT00523978|OG001|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
10891488|NCT00523978|EG000|Reported Event|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
10891489|NCT00523978|EG001|Reported Event|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
10891490|NCT00523991|BG000|Baseline|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
10891491|NCT00523991|BG001|Baseline|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
10891492|NCT00523991|BG002|Baseline|Total|Total of all reporting groups
10891493|NCT00523991|FG000|Participant Flow|Placebo|Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol
10891494|NCT00523991|FG001|Participant Flow|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
10891495|NCT00523991|OG000|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
10891496|NCT00523991|OG001|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
10891497|NCT00523991|EG000|Reported Event|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
10891498|NCT00523991|EG001|Reported Event|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
10891499|NCT00524017|BG000|Baseline|Arm I (Treatment)|"Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity.~cetuximab: given IV"
10891500|NCT00524017|BG001|Baseline|Arm II (Control)|Patients receive regular follow-up care
10891501|NCT00524017|BG002|Baseline|Total|Total of all reporting groups
10891502|NCT00524017|FG000|Participant Flow|Arm I (Treatment)|"Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity.~cetuximab: given IV"
10891503|NCT00524017|FG001|Participant Flow|Arm II (Control)|Patients receive regular follow-up care
10891504|NCT00524017|OG000|Outcome|Arm I (Treatment)|"Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity.~cetuximab: given IV"
10891505|NCT00524017|OG001|Outcome|Arm II (Control)|Patients receive regular follow-up care
10891506|NCT00524017|EG000|Reported Event|Arm I (Treatment)|"Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity.~cetuximab: given IV"
10891507|NCT00524017|EG001|Reported Event|Arm II (Control)|Patients receive regular follow-up care
10891508|NCT00524030|BG000|Baseline|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
10891509|NCT00524030|BG001|Baseline|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
10891510|NCT00524030|BG002|Baseline|Total|Total of all reporting groups
10891511|NCT00524030|FG000|Participant Flow|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
10891512|NCT00524030|FG001|Participant Flow|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
10891513|NCT00524030|OG000|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
10891514|NCT00524030|OG000|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
10891515|NCT00524030|OG001|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
10891516|NCT00524030|EG000|Reported Event|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
10891517|NCT00524030|EG001|Reported Event|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
10891518|NCT00524043|BG000|Baseline|Placebo|One oral placebo tablet daily for 6 weeks.
10891519|NCT00524043|BG001|Baseline|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
10891520|NCT00524043|BG002|Baseline|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
10891521|NCT00524043|BG003|Baseline|Total|Total of all reporting groups
10891522|NCT00524043|FG000|Participant Flow|Placebo|One oral placebo tablet daily for 6 weeks.
10891523|NCT00524043|FG001|Participant Flow|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
10891524|NCT00524043|FG002|Participant Flow|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
10891525|NCT00524043|OG000|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
10891526|NCT00524043|OG001|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
10891527|NCT00524043|OG002|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
10891528|NCT00524043|EG000|Reported Event|Placebo|One oral placebo tablet daily for 6 weeks.
10891529|NCT00524043|EG001|Reported Event|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
10891530|NCT00524043|EG002|Reported Event|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
10891531|NCT00524121|BG000|Baseline|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
10891532|NCT00524121|FG000|Participant Flow|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
10891533|NCT00524121|OG000|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
10891534|NCT00524121|OG000|Outcome|Erlotinib in Combination With Radiotherapy at Baseline|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
11335621|NCT03554005|OG000|Outcome|PEG Interferon Alfa-2b 0.75 mcg/kg OW|Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10891535|NCT00524121|OG001|Outcome|Erlotinib in Combination With Radiotherapy at Week 3|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
10891536|NCT00524121|OG000|Outcome|Current Smokers|
11171203|NCT02001194|OG003|Outcome|Individual Plus Team|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.~Individual plus Team Incentives"
11171204|NCT02001194|EG000|Reported Event|Control|Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
10891537|NCT00524121|OG001|Outcome|Former Smokers|
10891538|NCT00524121|OG002|Outcome|Never Smokers|
10891539|NCT00524121|OG000|Outcome|EGFR<=120 μg/ml|Cut at median of 120 EGFR<=120 μg/ml
10891540|NCT00524121|OG001|Outcome|EGFR>120 μg/ml|Cut at median of 120 EGFR>120 μg/ml
10891541|NCT00524121|OG000|Outcome|pEGFR<=20 μg/ml|Cut at median of 20 pEGFR<=20 μg/ml
10891542|NCT00524121|OG001|Outcome|pEGFR>20 μg/ml|Cut at median of 20 pEGFR>20 μg/ml
10891543|NCT00524121|OG000|Outcome|No EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
10891544|NCT00524121|OG001|Outcome|EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
10891545|NCT00524121|EG000|Reported Event|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
10891546|NCT00524173|BG000|Baseline|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
10891547|NCT00524173|BG001|Baseline|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
10891548|NCT00524173|BG002|Baseline|Total|Total of all reporting groups
10891549|NCT00524173|FG000|Participant Flow|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
10891550|NCT00524173|FG001|Participant Flow|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
10891551|NCT00524173|OG000|Outcome|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
10891552|NCT00524173|OG001|Outcome|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
10891553|NCT00524173|EG000|Reported Event|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
10891554|NCT00524173|EG001|Reported Event|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
10891555|NCT00524225|BG000|Baseline|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
10891556|NCT00524225|FG000|Participant Flow|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
10891557|NCT00524225|OG000|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
10891558|NCT00524225|OG000|Outcome|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
10891559|NCT00524225|EG000|Reported Event|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
10891560|NCT00524264|BG000|Baseline|Ketorolac Solution|
10891561|NCT00524264|BG001|Baseline|Vehicle Solution|
10891562|NCT00524264|BG002|Baseline|Total|Total of all reporting groups
10891563|NCT00524264|FG000|Participant Flow|Ketorolac Solution|
10891564|NCT00524264|FG001|Participant Flow|Vehicle Solution|
10891565|NCT00524264|OG000|Outcome|Ketorolac Solution|
10891566|NCT00524264|OG001|Outcome|Vehicle Solution|
10891567|NCT00524264|EG000|Reported Event|Ketorolac Solution|
10891568|NCT00524264|EG001|Reported Event|Vehicle Solution|
10891569|NCT00524303|BG000|Baseline|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
10891570|NCT00524303|BG001|Baseline|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
11171205|NCT02001194|EG001|Reported Event|Individual|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.~Individual Incentives"
11171206|NCT02001194|EG002|Reported Event|Team|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.~Team Incentives"
11171207|NCT02001194|EG003|Reported Event|Individual Plus Team|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.~Individual plus Team Incentives"
11171208|NCT02001558|BG000|Baseline|Microcyn|Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24
11171209|NCT02001558|BG001|Baseline|Sterile Saline|Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24
11171210|NCT02001558|BG002|Baseline|Total|Total of all reporting groups
11171211|NCT02001558|FG000|Participant Flow|Microcyn|Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24
11171212|NCT02001558|FG001|Participant Flow|Sterile Saline|Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24
11171213|NCT02001558|OG000|Outcome|Microcyn|Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24
10891571|NCT00524303|BG002|Baseline|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
10891572|NCT00524303|BG003|Baseline|Total|Total of all reporting groups
10891573|NCT00524303|FG000|Participant Flow|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
10891574|NCT00524303|FG001|Participant Flow|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
10891575|NCT00524303|FG002|Participant Flow|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
10891576|NCT00524303|OG000|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
10891577|NCT00524303|OG001|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
10891578|NCT00524303|OG002|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
10891579|NCT00524303|OG000|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams (mg)/kilogram (kg) on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter. Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
10891580|NCT00524303|OG001|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
10891581|NCT00524303|OG002|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
10891582|NCT00524303|EG000|Reported Event|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
10891583|NCT00524303|EG001|Reported Event|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
11171214|NCT02001558|OG001|Outcome|Sterile Saline|Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24
10891584|NCT00524303|EG002|Reported Event|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
10891585|NCT00524316|BG000|Baseline|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
10891586|NCT00524316|FG000|Participant Flow|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
10891587|NCT00524316|OG000|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
10891588|NCT00524316|EG000|Reported Event|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
10891589|NCT00524342|BG000|Baseline|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
10891590|NCT00524342|FG000|Participant Flow|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
10891591|NCT00524342|OG000|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
10891592|NCT00524342|EG000|Reported Event|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
10891593|NCT00524368|BG000|Baseline|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
10891594|NCT00524368|BG001|Baseline|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
10891595|NCT00524368|BG002|Baseline|Total|Total of all reporting groups
10891596|NCT00524368|FG000|Participant Flow|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
10891597|NCT00524368|FG001|Participant Flow|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
10891598|NCT00524368|OG000|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
10891599|NCT00524368|OG001|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
10891600|NCT00524368|EG000|Reported Event|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
10891601|NCT00524368|EG001|Reported Event|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
10891602|NCT00524420|BG000|Baseline|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
10891603|NCT00524420|BG001|Baseline|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
10891604|NCT00524420|BG002|Baseline|Total|Total of all reporting groups
10891605|NCT00524420|FG000|Participant Flow|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
10891606|NCT00524420|FG001|Participant Flow|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
10891607|NCT00524420|OG000|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
11090149|NCT01527110|FG000|Participant Flow|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kilogram (kg) with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 minutes (min) for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated creatinine clearance (CLcr) with the initial dose corresponding to a CLcr of > =80 milliliter per min (mL/min) for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
11090150|NCT01527110|OG000|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
10891608|NCT00524420|OG001|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
10891609|NCT00524420|OG000|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
10891610|NCT00524420|OG001|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
10891611|NCT00524420|EG000|Reported Event|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
10891612|NCT00524420|EG001|Reported Event|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
10891613|NCT00524472|BG000|Baseline|Hyperinsulinemic-normoglycemic Clamp|"Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.~Hyperinsulinemic-normoglycemic clamp: Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL."
10891614|NCT00524472|BG001|Baseline|Insulin at the Standard of Care Levels|"Group B will be administered insulin at the standard of care levels established by the participating institution.~insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution."
10891615|NCT00524472|BG002|Baseline|Total|Total of all reporting groups
10891616|NCT00524472|FG000|Participant Flow|Hyperinsulinemic-normoglycemic Clamp|"Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.~Hyperinsulinemic-normoglycemic clamp: Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL."
10891617|NCT00524472|FG001|Participant Flow|Insulin at the Standard of Care Levels|"Group B will be administered insulin at the standard of care levels established by the participating institution.~insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution."
10891618|NCT00524472|OG000|Outcome|Hyperinsulinemic-normoglycemic Clamp|"Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.~Hyperinsulinemic-normoglycemic clamp: Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL."
10891619|NCT00524472|OG001|Outcome|Insulin at the Standard of Care Levels|"Group B will be administered insulin at the standard of care levels established by the participating institution.~insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution."
10891620|NCT00524472|EG000|Reported Event|Hyperinsulinemic-normoglycemic Clamp|"Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.~Hyperinsulinemic-normoglycemic clamp: Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL."
10891621|NCT00524472|EG001|Reported Event|Insulin at the Standard of Care Levels|"Group B will be administered insulin at the standard of care levels established by the participating institution.~insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution."
10891622|NCT00524537|BG000|Baseline|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
10891623|NCT00524537|FG000|Participant Flow|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
10891624|NCT00524537|OG000|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
10891625|NCT00524537|EG000|Reported Event|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
10891626|NCT00524576|BG000|Baseline|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
10891627|NCT00524576|BG001|Baseline|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
10891628|NCT00524576|BG002|Baseline|Total|Total of all reporting groups
10891629|NCT00524576|FG000|Participant Flow|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
10891630|NCT00524576|FG001|Participant Flow|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
10891631|NCT00524576|OG000|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
10891632|NCT00524576|OG001|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
10891633|NCT00524576|EG000|Reported Event|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
10891634|NCT00524576|EG001|Reported Event|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
10891635|NCT00524589|BG000|Baseline|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
10891636|NCT00524589|FG000|Participant Flow|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
10891637|NCT00524589|OG000|Outcome|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
10891638|NCT00524589|EG000|Reported Event|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
10891639|NCT00524680|BG000|Baseline|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
10891640|NCT00524680|BG001|Baseline|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891641|NCT00524680|BG002|Baseline|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891642|NCT00524680|BG003|Baseline|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891643|NCT00524680|BG004|Baseline|Total|Total of all reporting groups
10891644|NCT00524680|FG000|Participant Flow|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
10891645|NCT00524680|FG001|Participant Flow|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891646|NCT00524680|FG002|Participant Flow|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891647|NCT00524680|FG003|Participant Flow|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891648|NCT00524680|OG000|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
10891649|NCT00524680|OG001|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891650|NCT00524680|OG002|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
11171215|NCT02001558|EG000|Reported Event|Microcyn|Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24
10891651|NCT00524680|OG003|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891652|NCT00524680|EG000|Reported Event|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
10891653|NCT00524680|EG001|Reported Event|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891654|NCT00524680|EG002|Reported Event|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891655|NCT00524680|EG003|Reported Event|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
10891656|NCT00524745|BG000|Baseline|0,3,9 Month Schedule|
10891657|NCT00524745|BG001|Baseline|0,6,12 Month Schedule|
10891658|NCT00524745|BG002|Baseline|0,12,24 Month Schedule|
10891659|NCT00524745|BG003|Baseline|Standard (0,2,6 Month) Schedule|
10891660|NCT00524745|BG004|Baseline|Total|Total of all reporting groups
10891661|NCT00524745|FG000|Participant Flow|0,3,9 Month Schedule|
10891662|NCT00524745|FG001|Participant Flow|0,6,12 Month Schedule|
10891663|NCT00524745|FG002|Participant Flow|0,12,24 Month Schedule|
10891664|NCT00524745|FG003|Participant Flow|Standard (0,2,6 Month) Schedule|
10891665|NCT00524745|OG000|Outcome|0,3,9 Month Schedule|
10891666|NCT00524745|OG001|Outcome|0,6,12 Month Schedule|
10891667|NCT00524745|OG002|Outcome|0,12,24 Month Schedule|
10891668|NCT00524745|OG003|Outcome|Standard (0,2,6 Month) Schedule|
10891669|NCT00524745|EG000|Reported Event|0,3,9 Month Schedule|
10891670|NCT00524745|EG001|Reported Event|0,6,12 Month Schedule|
10891671|NCT00524745|EG002|Reported Event|0,12,24 Month Schedule|
10891672|NCT00524745|EG003|Reported Event|Standard (0,2,6 Month) Schedule|
10891673|NCT00524771|BG000|Baseline|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
10891674|NCT00524771|BG001|Baseline|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
10891675|NCT00524771|BG002|Baseline|Total|Total of all reporting groups
10891676|NCT00524771|FG000|Participant Flow|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
10891677|NCT00524771|FG001|Participant Flow|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
10891678|NCT00524771|OG000|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
10891679|NCT00524771|OG001|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
10891680|NCT00524771|OG002|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
10891681|NCT00524771|EG000|Reported Event|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
10891682|NCT00524771|EG001|Reported Event|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
10891683|NCT00524940|BG000|Baseline|Study Group|All participants enrolled and received Fluzone® Vaccine
10891684|NCT00524940|FG000|Participant Flow|Study Group|All participants enrolled and received Fluzone® Vaccine
10891685|NCT00524940|OG000|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
10891686|NCT00524940|EG000|Reported Event|Study Group|All participants enrolled and received Fluzone® Vaccine
10891687|NCT00525031|BG000|Baseline|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
10891688|NCT00525031|BG001|Baseline|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
10891689|NCT00525031|BG002|Baseline|Total|Total of all reporting groups
10891690|NCT00525031|FG000|Participant Flow|Temozolomide (TMZ)|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
10891691|NCT00525031|FG001|Participant Flow|Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI)|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
10891692|NCT00525031|OG000|Outcome|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
10891693|NCT00525031|OG001|Outcome|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
10891694|NCT00525031|OG000|Outcome|Overall Study|Arm A: TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks. Arm B: TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
10891695|NCT00525031|EG000|Reported Event|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
10891696|NCT00525031|EG001|Reported Event|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
10891697|NCT00525044|BG000|Baseline|Ambroxol Lozenges 20 mg|Patients were orally administered Ambroxol lozenges 20 milligram (mg) initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
10891698|NCT00525044|BG001|Baseline|Placebo|Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
10891699|NCT00525044|BG002|Baseline|Total|Total of all reporting groups
10891700|NCT00525044|FG000|Participant Flow|Ambroxol Lozenges 20 mg|Patients were orally administered Ambroxol lozenges 20 milligram (mg) initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
10891701|NCT00525044|FG001|Participant Flow|Placebo|Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
10891702|NCT00525044|OG000|Outcome|Ambroxol Lozenges 20 mg|Patients were orally administered Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
10891703|NCT00525044|OG001|Outcome|Placebo|Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
10891704|NCT00525044|EG000|Reported Event|Ambroxol Lozenges 20 mg|Patients were orally administered Ambroxol lozenges 20 milligram (mg) initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
10891705|NCT00525044|EG001|Reported Event|Placebo|Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
10891706|NCT00525057|BG000|Baseline|Interventional (Dalteparin, Metastatic)|Received dalteparin 5000 units daily postop, patients with metastatic disease.
10891707|NCT00525057|BG001|Baseline|Interventional (Dalteparin, Sarcoma)|Received dalteparin 5000 units daily postop, patients with primary sarcomas.
10891708|NCT00525057|BG002|Baseline|Total|Total of all reporting groups
10891709|NCT00525057|FG000|Participant Flow|Interventional (Dalteparin, Metastatic)|Received dalteparin 5000 units daily postop, patients with metastatic disease.
10891710|NCT00525057|FG001|Participant Flow|Interventional (Dalteparin, Sarcoma)|Received dalteparin 5000 units daily postop, patients with primary sarcomas.
10891711|NCT00525057|OG000|Outcome|Interventional (Dalteparin, Metastatic)|Received dalteparin 5000 units daily postop, patients with metastatic disease.
10891712|NCT00525057|OG001|Outcome|Interventional (Dalteparin, Sarcoma)|Received dalteparin 5000 units daily postop, patients with primary sarcomas.
10891713|NCT00525057|EG000|Reported Event|Interventional (Dalteparin, Metastatic)|Received dalteparin 5000 units daily postop, patients with metastatic disease.
10891714|NCT00525057|EG001|Reported Event|Interventional (Dalteparin, Sarcoma)|Received dalteparin 5000 units daily postop, patients with primary sarcomas.
10914746|NCT00632749|BG006|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914747|NCT00632749|BG007|Baseline|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914748|NCT00632749|BG008|Baseline|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914749|NCT00632749|BG009|Baseline|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914750|NCT00632749|BG010|Baseline|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10891715|NCT00525135|BG000|Baseline|Study Intervention|Patients receive valproic acid daily for 16 weeks.
10891716|NCT00525135|FG000|Participant Flow|Study Intervention|Patients receive valproic acid daily for 16 weeks.
10891717|NCT00525135|OG000|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
10891718|NCT00525135|EG000|Reported Event|Study Intervention|Patients receive valproic acid daily for 16 weeks.
10891719|NCT00525148|BG000|Baseline|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
10891720|NCT00525148|BG001|Baseline|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
10891721|NCT00525148|BG002|Baseline|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
10891722|NCT00525148|BG003|Baseline|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
10891723|NCT00525148|BG004|Baseline|Total|Total of all reporting groups
10891724|NCT00525148|FG000|Participant Flow|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
10891725|NCT00525148|FG001|Participant Flow|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
10891726|NCT00525148|FG002|Participant Flow|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
10891727|NCT00525148|FG003|Participant Flow|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
10891728|NCT00525148|OG000|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
10891729|NCT00525148|OG000|Outcome|Afatinib 30 mg|Subjects receiving 30 mg of Afatinib daily.
10891730|NCT00525148|OG001|Outcome|Afatinib 40 mg|Subjects receiving 40 mg of Afatinib daily.
10891731|NCT00525148|OG002|Outcome|Afatinib 50 mg|Subjects receiving 50 mg of Afatinib daily.
10891732|NCT00525148|OG000|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
10891733|NCT00525148|OG001|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
10891734|NCT00525148|EG000|Reported Event|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
10891735|NCT00525148|EG001|Reported Event|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
10891736|NCT00525161|BG000|Baseline|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
10891737|NCT00525161|FG000|Participant Flow|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
10891738|NCT00525161|OG000|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
11171216|NCT02001558|EG001|Reported Event|Sterile Saline|Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24
11171217|NCT02001688|BG000|Baseline|Kamada-AAT for Inhalation, 80mg|Daily inhalation of Kamada-AAT for Inhalation, 80mg
10891739|NCT00525161|EG000|Reported Event|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
10891740|NCT00525174|BG000|Baseline|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
10891741|NCT00525174|BG001|Baseline|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
10891742|NCT00525174|BG002|Baseline|Total|Total of all reporting groups
10891743|NCT00525174|FG000|Participant Flow|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
10891744|NCT00525174|FG001|Participant Flow|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
10891745|NCT00525174|OG000|Outcome|Bangerter|
10891746|NCT00525174|OG001|Outcome|Patching|
10891747|NCT00525174|EG000|Reported Event|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
10891748|NCT00525174|EG001|Reported Event|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
10891749|NCT00525265|BG000|Baseline|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
10891750|NCT00525265|BG001|Baseline|OPC-41061 15 mg|OPC-41061 15 mg/day
10891751|NCT00525265|BG002|Baseline|Total|Total of all reporting groups
10891752|NCT00525265|FG000|Participant Flow|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
10891753|NCT00525265|FG001|Participant Flow|OPC-41061 15 mg|OPC-41061 1.5 mg/day
10891754|NCT00525265|OG000|Outcome|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
11171218|NCT02001688|BG001|Baseline|Kamada-AAT for Inhalation, 160mg|Daily inhalation of Kamada-AAT for Inhalation, 160mg
11171219|NCT02001688|BG002|Baseline|Placebo|Placebo inhaled daily
11171220|NCT02001688|BG003|Baseline|Total|Total of all reporting groups
10891755|NCT00525265|OG001|Outcome|OPC-41061 15 mg|OPC-41061 15 mg/day
10891756|NCT00525265|EG000|Reported Event|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
10891757|NCT00525265|EG001|Reported Event|OPC-41061 15 mg|OPC-41061 15 mg/day
10891758|NCT00525421|BG000|Baseline|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
10891759|NCT00525421|BG001|Baseline|Placebo|Placebo : identical placebo tablets three times per day for 12 days
10891760|NCT00525421|BG002|Baseline|Total|Total of all reporting groups
10891761|NCT00525421|FG000|Participant Flow|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
10891762|NCT00525421|FG001|Participant Flow|Placebo|Placebo : identical placebo tablets three times per day for 12 days
10891763|NCT00525421|OG000|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
10891764|NCT00525421|OG001|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
10891765|NCT00525421|EG000|Reported Event|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
10891766|NCT00525421|EG001|Reported Event|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
10891767|NCT00525499|BG000|Baseline|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
10891768|NCT00525499|BG001|Baseline|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891769|NCT00525499|BG002|Baseline|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891770|NCT00525499|BG003|Baseline|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891771|NCT00525499|BG004|Baseline|Total|Total of all reporting groups
10891772|NCT00525499|FG000|Participant Flow|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
10891773|NCT00525499|FG001|Participant Flow|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891774|NCT00525499|FG002|Participant Flow|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891775|NCT00525499|FG003|Participant Flow|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891776|NCT00525499|OG000|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
10891777|NCT00525499|OG001|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891778|NCT00525499|OG002|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891779|NCT00525499|OG003|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891780|NCT00525499|EG000|Reported Event|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
10891781|NCT00525499|EG001|Reported Event|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891782|NCT00525499|EG002|Reported Event|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891783|NCT00525499|EG003|Reported Event|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
10891784|NCT00525512|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
10891785|NCT00525512|BG001|Baseline|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
11171221|NCT02001688|FG000|Participant Flow|Kamada-AAT for Inhalation, 80mg|Daily inhalation of Kamada-AAT for Inhalation, 80mg
11171222|NCT02001688|FG001|Participant Flow|Kamada-AAT for Inhalation, 160mg|Daily inhalation of Kamada-AAT for Inhalation, 160mg
10891786|NCT00525512|BG002|Baseline|Total|Total of all reporting groups
10891787|NCT00525512|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
10891788|NCT00525512|FG001|Participant Flow|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
10891789|NCT00525512|FG002|Participant Flow|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
10891790|NCT00525512|FG003|Participant Flow|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
10891791|NCT00525512|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
10891792|NCT00525512|OG001|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
10891793|NCT00525512|OG000|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
10891794|NCT00525512|OG001|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
10891795|NCT00525512|OG002|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
10891796|NCT00525512|OG003|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
10891797|NCT00525512|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
10891798|NCT00525512|EG001|Reported Event|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
10891799|NCT00525512|EG002|Reported Event|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
10891800|NCT00525512|EG003|Reported Event|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
10891801|NCT00525525|BG000|Baseline|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
10891802|NCT00525525|BG001|Baseline|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
10891803|NCT00525525|BG002|Baseline|Total|Total of all reporting groups
11171223|NCT02001688|FG002|Participant Flow|Placebo|Placebo inhaled daily
11171224|NCT02001688|OG000|Outcome|Kamada-AAT for Inhalation, 80mg|Daily inhalation of Kamada-AAT for Inhalation, 80mg
10891804|NCT00525525|FG000|Participant Flow|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
10891805|NCT00525525|FG001|Participant Flow|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
10891806|NCT00525525|OG000|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
10891807|NCT00525525|OG000|Outcome|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
10891808|NCT00525525|EG000|Reported Event|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
10891809|NCT00525525|EG001|Reported Event|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
10891810|NCT00525590|BG000|Baseline|GLIADEL|Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed.
10891811|NCT00525590|FG000|Participant Flow|GLIADEL|Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 [milligram] mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed.
10891812|NCT00525590|OG000|Outcome|GLIADEL|Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine).
10891813|NCT00525590|EG000|Reported Event|GLIADEL|Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed.
11171225|NCT02001688|OG001|Outcome|Kamada-AAT for Inhalation, 160mg|Daily inhalation of Kamada-AAT for Inhalation, 160mg
11171226|NCT02001688|OG002|Outcome|Placebo|Combined placebo results from patients at the two clinical sites
11171227|NCT02001688|OG002|Outcome|Placebo|Placebo inhaled daily
11171228|NCT02001688|EG000|Reported Event|Kamada-AAT for Inhalation, 80mg|Daily inhalation of Kamada-AAT for Inhalation, 80mg
10891814|NCT00525603|BG000|Baseline|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
10891815|NCT00525603|FG000|Participant Flow|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
10891816|NCT00525603|OG000|Outcome|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
10891817|NCT00525603|EG000|Reported Event|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
10891818|NCT00525629|BG000|Baseline|All Patients|All patients received both interventions and are included in this group analysis
10891819|NCT00525629|FG000|Participant Flow|Walnut Diet First, Then Control Diet|patients were asked to consume 48g of walnuts per day
10891820|NCT00525629|FG001|Participant Flow|Control Diet First, Then Walnut di|patients were asked to consume an isocaloric Diet with no Nuts
10891821|NCT00525629|OG000|Outcome|Walnut Diet|"48 Grams of Walnuts Daily~Walnuts: 48 Grams of Walnuts Daily"
10891822|NCT00525629|OG001|Outcome|Control Diet|"Isocaloric Diet with No Walnuts~Control: Control Diet with No Walnuts"
10891823|NCT00525629|EG000|Reported Event|Walnut Diet|48g of walnuts per day
10891824|NCT00525629|EG001|Reported Event|Control Diet|Isocaloric Diet with no Nuts.
10891825|NCT00525733|BG000|Baseline|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
10891826|NCT00525733|BG001|Baseline|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
10891827|NCT00525733|BG002|Baseline|Total|Total of all reporting groups
10891828|NCT00525733|FG000|Participant Flow|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
10891829|NCT00525733|FG001|Participant Flow|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
10891830|NCT00525733|OG000|Outcome|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
10891831|NCT00525733|OG001|Outcome|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
10891832|NCT00525733|EG000|Reported Event|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
10891833|NCT00525733|EG001|Reported Event|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
10891834|NCT00525785|BG000|Baseline|5-Fluorouracil + Folinic Acid + Oxaliplatin|FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid & infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2 for 5 days) & weekly oxaliplatin 45 mg/m^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy
10891835|NCT00525785|FG000|Participant Flow|5-Fluorouracil + Folinic Acid + Oxaliplatin|"PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy).~PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2/d Monday through Friday) & weekly oxaliplatin 45 mg/m^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week).~Surgical resection 4-6 weeks after completion of chemoradiotherapy"
10891836|NCT00525785|OG000|Outcome|5-Fluorouracil + Folinic Acid + Oxaliplatin|FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid & infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2 for 5 days) & weekly oxaliplatin 45 mg/m^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy.
11171229|NCT02001688|EG001|Reported Event|Kamada-AAT for Inhalation, 160mg|Daily inhalation of Kamada-AAT for Inhalation, 160mg
11171230|NCT02001688|EG002|Reported Event|Placebo|Placebo inhaled daily
10891837|NCT00525785|EG000|Reported Event|5-Fluorouracil + Folinic Acid + Oxaliplatin|"PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy).~PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2/d Monday through Friday) & weekly oxaliplatin 45 mg/m^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week).~Surgical resection 4-6 weeks after completion of chemoradiotherapy"
10891838|NCT00525798|BG000|Baseline|SMC021|1 tablet of 0,80 mg SMC021 daily
10891839|NCT00525798|BG001|Baseline|Placebo|1 tablet of placebo daily
10891840|NCT00525798|BG002|Baseline|Total|Total of all reporting groups
10891841|NCT00525798|FG000|Participant Flow|SMC021|1 tablet of 0,80 mg SMC021 daily
10891842|NCT00525798|FG001|Participant Flow|Placebo|1 tablet of placebo daily
10891843|NCT00525798|OG000|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
10891844|NCT00525798|OG001|Outcome|Placebo|1 tablet of placebo daily
10891845|NCT00525798|EG000|Reported Event|SMC021|1 tablet of 0,80 mg SMC021 daily
11090151|NCT01527110|EG000|Reported Event|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
11090152|NCT01527162|BG000|Baseline|All Participants|We used a randomized cross-over design with eleven children with bilateral 9 CP, mean age 4.3 years. Subjects were randomized to their current SAFO worn or SAFO not worn for 2 weeks and then crossed over.
11090153|NCT01527162|FG000|Participant Flow|SAFO Worn First, Then Not Worn|Child wears their prescribed SAFO for 14 days by random assignment and then not worn
10891846|NCT00525798|EG001|Reported Event|Placebo|1 tablet of placebo daily
10891847|NCT00525824|BG000|Baseline|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
10891848|NCT00525824|BG001|Baseline|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
11090154|NCT01527162|FG001|Participant Flow|SAFO NOT Worn First, Then Worn|Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn
11090155|NCT01527162|OG000|Outcome|SAFO Worn|"Child wears their prescribed SAFO for 14 days~SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment~SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment"
11090156|NCT01527162|OG001|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
11090157|NCT01527162|OG000|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
11090158|NCT01527162|OG001|Outcome|SAFO Not Worn|Child does not wears their prescribed SAFO for 14 days
11090159|NCT01527162|EG000|Reported Event|SAFO Worn|SAFO worn: Child wears their prescirbed SAFO for 14 dyas by random assignment
11090160|NCT01527162|EG001|Reported Event|SAFO Not Worn|SAFO not worn: Child does ont wear their prescribed SAFO for 14 days by random assignment
11090161|NCT01527357|BG000|Baseline|Fibrocaps + Gelatin Sponge|Single application of Fibrocaps plus gelatin sponge.
11090162|NCT01527357|BG001|Baseline|Gelatin Sponge|Single application of gelatin sponge alone.
11090163|NCT01527357|BG002|Baseline|Total|Total of all reporting groups
11090164|NCT01527357|FG000|Participant Flow|Fibrocaps + Gelatin Sponge|Single application of Fibrocaps plus gelatin sponge.
11090165|NCT01527357|FG001|Participant Flow|Gelatin Sponge|Single application of gelatin sponge alone.
10891849|NCT00525824|BG002|Baseline|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
10891850|NCT00525824|BG003|Baseline|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
10891851|NCT00525824|BG004|Baseline|Total|Total of all reporting groups
10891852|NCT00525824|FG000|Participant Flow|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
10891853|NCT00525824|FG001|Participant Flow|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
10891854|NCT00525824|FG002|Participant Flow|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
10891855|NCT00525824|FG003|Participant Flow|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
10891856|NCT00525824|OG000|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
10891857|NCT00525824|OG001|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
10891858|NCT00525824|OG002|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
10891859|NCT00525824|OG003|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
10891860|NCT00525824|EG000|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg Monotherapy arm
10891861|NCT00525824|EG001|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg Monotherapy arm
10891862|NCT00525824|EG002|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg Monotherapy arm
10891863|NCT00525824|EG003|Reported Event|Simvastatin 80 mg|Simvastatin 80 mg Monotherapy arm
10891864|NCT00525824|EG004|Reported Event|Rosu 10 mg + Eze 10 mg|Rosuvastatin 10 mg + Ezetimibe 10 mg
10891865|NCT00525824|EG005|Reported Event|Rosu 20 mg + Eze 10 mg|Rosuvastatin 20 mg + Ezetimibe 10 mg
10891866|NCT00525824|EG006|Reported Event|Simva 40 mg + Eze 10 mg|Simvastatin 40 mg + Ezetimibe 10 mg
10891867|NCT00525824|EG007|Reported Event|Simva 80 mg + Eze 10 mg|Simvastatin 80 mg + Ezetimibe 10 mg
10891868|NCT00525837|BG000|Baseline|Varenicline|
10891869|NCT00525837|FG000|Participant Flow|Varenicline|
10891870|NCT00525837|OG000|Outcome|Varenicline|
10891871|NCT00525837|OG000|Outcome|Varenicline|"open label varenicline~fixed dose varenicline: varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration.~varenicline: up to 1 mg twice daily"
10891872|NCT00525837|EG000|Reported Event|Varenicline|
10891873|NCT00525876|BG000|Baseline|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
10891874|NCT00525876|BG001|Baseline|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
10891875|NCT00525876|BG002|Baseline|Total|Total of all reporting groups
11090166|NCT01527357|OG000|Outcome|Fibrocaps + Gelatin Sponge|Single application of Fibrocaps plus gelatin sponge.
11090167|NCT01527357|OG001|Outcome|Gelatin Sponge|Single application of gelatin sponge alone.
11090168|NCT01527357|EG000|Reported Event|Fibrocaps + Gelatin Sponge|Single application of Fibrocaps plus gelatin sponge.
11090169|NCT01527357|EG001|Reported Event|Gelatin Sponge|Single application of gelatin sponge alone.
11090170|NCT01527370|BG000|Baseline|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
11090171|NCT01527370|FG000|Participant Flow|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
11090172|NCT01527370|OG000|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
11090173|NCT01527370|EG000|Reported Event|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
11090174|NCT01527383|BG000|Baseline|V212|Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090175|NCT01527383|BG001|Baseline|Placebo|Participants received placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090176|NCT01527383|BG002|Baseline|Total|Total of all reporting groups
11090177|NCT01527383|FG000|Participant Flow|V212|Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090178|NCT01527383|FG001|Participant Flow|Placebo|Participants received placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090179|NCT01527383|OG000|Outcome|V212|Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090180|NCT01527383|OG001|Outcome|Placebo|Participants received placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090181|NCT01527383|EG000|Reported Event|V212|Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090182|NCT01527383|EG001|Reported Event|Placebo|Participants received placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090183|NCT01527487|BG000|Baseline|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard;~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
11090184|NCT01527487|BG001|Baseline|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion;~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
11090185|NCT01527487|BG002|Baseline|Total|Total of all reporting groups
11090186|NCT01527487|FG000|Participant Flow|Eribulin+Cyclophosphamide: ErC|"Eribulin (Er): 1.4 mg/m^2 by IV infusion (Days 1 and 8); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)~Administered every 21 days for 6 cycles followed by surgery."
11090187|NCT01527487|FG001|Participant Flow|Docetaxel+Cyclophosphamide: TC|"Docetaxel (T): 75 mg/m^2 by IV infusion (Day 1); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)tandard.~Administered every 21 days for 6 cycles followed by surgery."
11090188|NCT01527487|OG000|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion"
11090189|NCT01527487|OG001|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)"
11090190|NCT01527487|OG000|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
11090191|NCT01527487|OG001|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
11090192|NCT01527487|OG000|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion."
11090193|NCT01527487|OG000|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 IV (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle by IV infusion."
11090194|NCT01527487|OG001|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.~Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
10891876|NCT00525876|FG000|Participant Flow|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
10891877|NCT00525876|FG001|Participant Flow|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
10891878|NCT00525876|OG000|Outcome|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
10891879|NCT00525876|OG001|Outcome|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
10891880|NCT00525876|EG000|Reported Event|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
10891881|NCT00525876|EG001|Reported Event|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
10891882|NCT00525902|BG000|Baseline|Adalimumab|
10891883|NCT00525902|FG000|Participant Flow|Adalimumab|
11171231|NCT02001714|BG000|Baseline|Group Behavioral Treatment|"Participants will attend a group behavioral treatment class and follow-up visits.~Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class."
10891884|NCT00525902|OG000|Outcome|Adalimumab|
10891885|NCT00525902|EG000|Reported Event|Adalimumab|
10891886|NCT00525915|BG000|Baseline|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
10891887|NCT00525915|BG001|Baseline|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
10891888|NCT00525915|BG002|Baseline|Total|Total of all reporting groups
10891889|NCT00525915|FG000|Participant Flow|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
10891890|NCT00525915|FG001|Participant Flow|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
10891891|NCT00525915|OG000|Outcome|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
10891892|NCT00525915|OG001|Outcome|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
10891893|NCT00525915|EG000|Reported Event|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
10891894|NCT00525915|EG001|Reported Event|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
10891895|NCT00526058|BG000|Baseline|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
10891896|NCT00526058|BG001|Baseline|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
10891897|NCT00526058|BG002|Baseline|Total|Total of all reporting groups
10891898|NCT00526058|FG000|Participant Flow|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
10891899|NCT00526058|FG001|Participant Flow|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
10891900|NCT00526058|OG000|Outcome|Secura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
10891901|NCT00526058|OG001|Outcome|Futura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
10891902|NCT00526058|EG000|Reported Event|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
10891903|NCT00526058|EG001|Reported Event|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
10891904|NCT00526071|BG000|Baseline|Migalastat|Participants received migalastat 150 mg given orally QOD before and after the DEP. During the DEP participants received 250 mg QD for 3 days, 4 days off per week for 2 months then 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site. One participant received migalastat 300 mg (QD for 3 days and 4 days off per week) until the end of the study.
10891905|NCT00526071|FG000|Participant Flow|Migalastat|Participants received migalastat 150 mg given orally once every other day (QOD) before and after the DEP. During the DEP participants received 250 mg once daily (QD) for 3 days, 4 days off per week for 2 months then 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site. One participant received migalastat 300 mg (QD for 3 days and 4 days off per week) until the end of the study.
10891906|NCT00526071|OG000|Outcome|Migalastat|Participants received migalastat 150 mg given orally QOD before and after the DEP. During the DEP participants received 250 mg QD for 3 days, 4 days off per week for 2 months then 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site. One participant received migalastat 300 mg (QD for 3 days and 4 days off per week) until the end of the study.
10891907|NCT00526071|OG000|Outcome|Amenable Population; Men|Amenable participants were those with mutant forms of α-Gal A determined to be responsive to migalastat treatment based on the CT-HEK assay. Migalastat was administered orally, 150 mg QOD before and after the DEP. During the DEP participants received 250 mg QD for 3 days, 4 days off per week for 2 months then 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site. One participant received migalastat 300 mg (QD for 3 days and 4 days off per week) until the end of the study.
11171232|NCT02001714|BG001|Baseline|No Treatment|Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
11171233|NCT02001714|BG002|Baseline|Total|Total of all reporting groups
11171234|NCT02001714|FG000|Participant Flow|Group Behavioral Treatment|"Participants will attend a group behavioral treatment class and follow-up visits.~Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class."
11171235|NCT02001714|FG001|Participant Flow|No Treatment|Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
11171236|NCT02001714|OG000|Outcome|Group Behavioral Treatment|"Participants will attend a group behavioral treatment class and follow-up visits.~Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class."
11171237|NCT02001714|OG001|Outcome|No Treatment|Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
11171238|NCT02001714|EG000|Reported Event|Group Behavioral Treatment|"Participants will attend a group behavioral treatment class and follow-up visits.~Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class."
11171239|NCT02001714|EG001|Reported Event|No Treatment|Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
11335622|NCT03554005|OG001|Outcome|PEG Interferon Alfa-2b 1.5 mcg/kg OW|Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10891908|NCT00526071|OG001|Outcome|Amenable Population; Women|Amenable participants were those with mutant forms of α-Gal A determined to be responsive to migalastat treatment based on the CT-HEK assay. Migalastat was administered orally, 150 mg QOD before and after the DEP. During the DEP participants received 250 mg QD for 3 days, 4 days off per week for 2 months then 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site.
10891909|NCT00526071|OG002|Outcome|Non-amenable Population; Men|Non-amenable participants were those without mutant forms of α-Gal A as determined by the CT-HEK assay. Migalastat was administered orally, 150 mg QOD before and after the DEP. During the DEP participants received 250 mg QD for 3 days, 4 days off per week for 2 months then 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site.
10891910|NCT00526071|OG003|Outcome|Non-amenable Population; Women|Non-amenable participants were those without mutant forms of α-Gal A as determined by the CT-HEK assay. Migalastat was administered orally, 150 mg QOD before and after the DEP. During the DEP participants received 250 mg QD for 3 days, 4 days off per week for 2 months then 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site.
10891911|NCT00526071|EG000|Reported Event|Migalastat|Participants received migalastat 150 mg given orally QOD before and after the DEP. During the DEP participants received 250 mg QD for 3 days, 4 days off per week for 2 months then 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site. One participant received migalastat 300 mg (QD for 3 days and 4 days off per week) until the end of the study.
10891912|NCT00526097|BG000|Baseline|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
10891913|NCT00526097|BG001|Baseline|Bisacodyl|Two bisacodyl 5 mg tablets once daily
10891914|NCT00526097|BG002|Baseline|Total|Total of all reporting groups
10891915|NCT00526097|FG000|Participant Flow|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
10891916|NCT00526097|FG001|Participant Flow|Bisacodyl|Two bisacodyl 5 mg tablets once daily
10891917|NCT00526097|OG000|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
10891918|NCT00526097|OG001|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
10891919|NCT00526097|EG000|Reported Event|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
10891920|NCT00526097|EG001|Reported Event|Bisacodyl|Two bisacodyl 5 mg tablets once daily
10891921|NCT00526110|BG000|Baseline|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
10891922|NCT00526110|BG001|Baseline|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
10891923|NCT00526110|BG002|Baseline|Total|Total of all reporting groups
10891924|NCT00526110|FG000|Participant Flow|Phase I: Dose Escalation|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
10891925|NCT00526110|FG001|Participant Flow|Phase II: Docetaxel MTD 50 mg/m^2|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
10891926|NCT00526110|OG000|Outcome|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
10891927|NCT00526110|OG000|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
10891928|NCT00526110|EG000|Reported Event|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
10891929|NCT00526110|EG001|Reported Event|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
10891930|NCT00526123|BG000|Baseline|Symmetric Tip|symmetric tip hemodialysis catheter
10891931|NCT00526123|BG001|Baseline|Split-tip|split-tip hemodialysis catheter
10891932|NCT00526123|BG002|Baseline|Total|Total of all reporting groups
10891933|NCT00526123|FG000|Participant Flow|Symmetric Tip|symmetric tip hemodialysis catheter
10891934|NCT00526123|FG001|Participant Flow|Split-tip|split-tip hemodialysis catheter
10891935|NCT00526123|OG000|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
10891936|NCT00526123|OG001|Outcome|Split-tip|split-tip hemodialysis catheter
10891937|NCT00526123|EG000|Reported Event|Symmetric Tip|symmetric tip hemodialysis catheter
10891938|NCT00526123|EG001|Reported Event|Split-tip|split-tip hemodialysis catheter
10891939|NCT00526162|BG000|Baseline|Consulta Implant|Patients implanted with a Consulta Cardiac Resynchronization Therapy (CRT)-D device
10891940|NCT00526162|FG000|Participant Flow|Consulta Implant|Patients implanted with a Consulta device
10891941|NCT00526162|OG000|Outcome|Consulta Implant|Patients implanted with a Consulta device
10891942|NCT00526162|OG000|Outcome|Consulta Implant|Patients with a Consulta device implanted
10891943|NCT00526162|OG000|Outcome|Consulta Implant|The first 20 patients implanted with a Consulta device that has a successful Holter recording
10891944|NCT00526162|OG000|Outcome|Implantation of Consulta CRT-D|Patients implanted with a Bi-ventricular Implantable Cardioverter Defibrillator
10891945|NCT00526162|OG000|Outcome|Implantation of Consulta CRT-D|Patients that are successfully implanted with a Bi-ventricular Implantable Cardioverter Defibrillator
10891946|NCT00526162|EG000|Reported Event|Consulta Implant|Patients implanted with a Consulta CRT-D device
10891947|NCT00526188|BG000|Baseline|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
10891948|NCT00526188|FG000|Participant Flow|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
10891949|NCT00526188|OG000|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
10891950|NCT00526188|EG000|Reported Event|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
10891951|NCT00526292|BG000|Baseline|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
10891952|NCT00526292|FG000|Participant Flow|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
10891953|NCT00526292|OG000|Outcome|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
10891954|NCT00526292|EG000|Reported Event|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
10891955|NCT00526474|BG000|Baseline|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
10891956|NCT00526474|BG001|Baseline|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
10891957|NCT00526474|BG002|Baseline|Total|Total of all reporting groups
10891958|NCT00526474|FG000|Participant Flow|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
10891959|NCT00526474|FG001|Participant Flow|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
10891960|NCT00526474|OG000|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
10891961|NCT00526474|OG001|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
10891962|NCT00526474|EG000|Reported Event|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
10891963|NCT00526474|EG001|Reported Event|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
11171240|NCT02001987|BG000|Baseline|TCZ - All Participants|Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks. Participants who completed the core study period were allowed to enter a LTE period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
10891964|NCT00526591|BG000|Baseline|Low-dose Cohort|"Patients will receive 5.0mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
11233201|NCT02424799|BG001|Baseline|Part A-GSK2646264 1% and Placebo|Participants received active treatment (1% cream strength) and placebo on Days 1, 2, 3 and 4. On Day 1 and Day 2, participants received treatment to 0.2% BSA; active treatment on one arm and placebo on the other arm. In addition, participants received treatment to another 5% BSA; active to one side of the torso and placebo to the other. On Days 3 and 4, the same treatment to the arms was applied as on Days 1 and 2, but the %BSA of the torso to which treatment was applied to was increased to 10%.
10891965|NCT00526591|BG001|Baseline|High-dose Cohort|"Patients will receive 10mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
10891966|NCT00526591|BG002|Baseline|Total|Total of all reporting groups
10891967|NCT00526591|FG000|Participant Flow|Low-dose Cohort|"Patients will receive 5.0mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
10891968|NCT00526591|FG001|Participant Flow|High-dose Cohort|"Patients will receive 10mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
10891969|NCT00526591|OG000|Outcome|Low-dose Cohort|"Patients will receive 5.0mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
10891970|NCT00526591|OG001|Outcome|High-dose Cohort|"Patients will receive 10mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
10891971|NCT00526591|OG000|Outcome|High-dose Cohort|"Patients will receive 10mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
10891972|NCT00526591|OG001|Outcome|Low-dose Cohort|"Patients will receive 5.0mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
11171241|NCT02001987|FG000|Participant Flow|TCZ - All Participants|Participants in core study period received tocilizumab (TCZ, RoActemra) at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week as monotherapy or in combination with Methotrexate (MTX) or other Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) (at investigator's discretion) for 24 weeks. Participants who completed the core study period were allowed to enter a Long-term-extension (LTE) period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
11171242|NCT02001987|OG000|Outcome|TCZ - All Participants - Core Study Period|Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
11171243|NCT02001987|OG000|Outcome|TCZ MONO - Core Study Period|Participants who did not receive treatment with any csDMARDs 4 weeks prior first TCZ administration and received monotherapy with TCZ at a dose of 162 mg as SC injection once a week for 24 weeks.
11171244|NCT02001987|OG001|Outcome|TCZ COMBO - Core Study Period|Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
11171245|NCT02001987|OG000|Outcome|TCZ - All Participants|Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks. Participants who completed the core study period were allowed to enter a LTE period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
10891973|NCT00526591|EG000|Reported Event|Low-dose Cohort|"Patients will receive 5.0mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
10891974|NCT00526591|EG001|Reported Event|High-dose Cohort|"Patients will receive 10mg P.O. daily continuously for 8 weeks~everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks~conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus)."
10891975|NCT00526630|BG000|Baseline|All Participants|Participants were randomized to receive both MPD and placebo.
10891976|NCT00526630|FG000|Participant Flow|MPD Then Placebo|First group treated with MPD then placebo
10891977|NCT00526630|FG001|Participant Flow|Placebo Then MPD|First group treated with placebo then MPD
10891978|NCT00526630|OG000|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
10891979|NCT00526630|OG001|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
10891980|NCT00526630|OG002|Outcome|Baseline|Baseline gait composite scores
10891981|NCT00526630|OG002|Outcome|Baseline|All participants with baseline data
10891982|NCT00526630|EG000|Reported Event|1. MPD|"Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.~Methylphenidate (MPD): Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day."
10891983|NCT00526630|EG001|Reported Event|2. Placebo|"Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.~Placebo: Participants will be given placebo instead of active MPD."
10891984|NCT00526656|BG000|Baseline|Sunitinib Malate|"Drug~sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off"
10891985|NCT00526656|FG000|Participant Flow|Sunitinib Malate|"Drug~sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off"
10891986|NCT00526656|OG000|Outcome|Sunitinib Malate|"Drug~sunitinib malate: 50mg PO daily 4 weeks on -2 weeks off"
10891987|NCT00526656|OG000|Outcome|Sunitinib Malate|"Drug~sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off"
10891988|NCT00526656|EG000|Reported Event|Sunitinib Malate|"Drug~sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off"
11171246|NCT02001987|EG000|Reported Event|TCZ MONO - All Participants|Participants who did not receive treatment with any csDMARDs 4 weeks prior first TCZ administration and received monotherapy with TCZ at a dose of 162 mg as SC injection once a week for 24 weeks. Participants who completed the core study period were allowed to enter a LTE period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
11171247|NCT02001987|EG001|Reported Event|TCZ COMBO - All Participants|Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks. Participants who completed the core study period were allowed to enter a LTE period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
10891989|NCT00526669|BG000|Baseline|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
10891990|NCT00526669|FG000|Participant Flow|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
10891991|NCT00526669|FG001|Participant Flow|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
10891992|NCT00526669|OG000|Outcome|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
10891993|NCT00526669|OG000|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
10891994|NCT00526669|OG000|Outcome|Overall Study Arm|
10891995|NCT00526669|EG000|Reported Event|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
10891996|NCT00526799|BG000|Baseline|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
10891997|NCT00526799|BG001|Baseline|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
10891998|NCT00526799|BG002|Baseline|Total|Total of all reporting groups
10891999|NCT00526799|FG000|Participant Flow|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
10892000|NCT00526799|FG001|Participant Flow|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
10892001|NCT00526799|OG000|Outcome|Phase I Participants|Phase I Participants evaluable for MTD
10892002|NCT00526799|OG000|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
10892003|NCT00526799|OG000|Outcome|Phase I & II|"Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily during phase II.~During phase I:~Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
10892004|NCT00526799|EG000|Reported Event|Phase I/Phase II|All Phase I/Phase II participants
10892005|NCT00526890|BG000|Baseline|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
10892006|NCT00526890|FG000|Participant Flow|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
10892007|NCT00526890|OG000|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
10892008|NCT00526890|EG000|Reported Event|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
10892009|NCT00526994|BG000|Baseline|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
10892010|NCT00526994|BG001|Baseline|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
10892011|NCT00526994|BG002|Baseline|Control|no screen and no referral
10892012|NCT00526994|BG003|Baseline|Total|Total of all reporting groups
10892013|NCT00526994|FG000|Participant Flow|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
10892014|NCT00526994|FG001|Participant Flow|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
10892015|NCT00526994|FG002|Participant Flow|Control|no screen and no referral
10892016|NCT00526994|OG000|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
10892017|NCT00526994|OG001|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
10892018|NCT00526994|OG002|Outcome|Control|no screen and no referral
10892019|NCT00526994|EG000|Reported Event|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
10892020|NCT00526994|EG001|Reported Event|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
10892021|NCT00526994|EG002|Reported Event|Control|no screen and no referral
10892022|NCT00527072|BG000|Baseline|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
10892023|NCT00527072|FG000|Participant Flow|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
10892024|NCT00527072|OG000|Outcome|Infliximab|Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
10892025|NCT00527072|OG000|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
10892026|NCT00527072|EG000|Reported Event|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
10892027|NCT00527098|BG000|Baseline|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
10892028|NCT00527098|BG001|Baseline|Standard of Care|Routine Standard of Care Resuscitation Fluid
10892029|NCT00527098|BG002|Baseline|Total|Total of all reporting groups
10892030|NCT00527098|FG000|Participant Flow|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
10892031|NCT00527098|FG001|Participant Flow|Standard of Care|Routine Standard of Care Resuscitation Fluid
10892032|NCT00527098|OG000|Outcome|Observational|This is an observational trial.
10892033|NCT00527098|EG000|Reported Event|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
10892034|NCT00527098|EG001|Reported Event|Standard of Care|Routine Standard of Care Resuscitation Fluid
10892035|NCT00527111|BG000|Baseline|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
10892036|NCT00527111|BG001|Baseline|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
10892037|NCT00527111|BG002|Baseline|Total|Total of all reporting groups
10892038|NCT00527111|FG000|Participant Flow|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
10892039|NCT00527111|FG001|Participant Flow|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
10892040|NCT00527111|OG000|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
10892041|NCT00527111|OG001|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
10892042|NCT00527111|EG000|Reported Event|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
10892043|NCT00527111|EG001|Reported Event|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
10892044|NCT00527124|BG000|Baseline|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
10892045|NCT00527124|BG001|Baseline|Arm II|Patients receive docetaxel and prednisone as in arm I.
10892046|NCT00527124|BG002|Baseline|Total|Total of all reporting groups
10892047|NCT00527124|FG000|Participant Flow|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
10892048|NCT00527124|FG001|Participant Flow|Arm II|Patients receive docetaxel and prednisone as in arm I.
10892049|NCT00527124|OG000|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
10892050|NCT00527124|OG001|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
10892051|NCT00527124|EG000|Reported Event|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
10892052|NCT00527124|EG001|Reported Event|Arm II|Patients receive docetaxel and prednisone as in arm I.
10892053|NCT00527319|BG000|Baseline|Group A, Control Group|Supportive care only
10892054|NCT00527319|BG001|Baseline|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
10892055|NCT00527319|BG002|Baseline|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
10892056|NCT00527319|BG003|Baseline|Total|Total of all reporting groups
10892057|NCT00527319|FG000|Participant Flow|Group A, Control Group|Supportive care only
10892058|NCT00527319|FG001|Participant Flow|Group B, Low Dose VT-122|VT-122 low dose Supportive care
10892059|NCT00527319|FG002|Participant Flow|Group C, High Dose VT-122|VT-122 high dose Supportive care
10892060|NCT00527319|OG000|Outcome|Group A, Control Group|Supportive care only
10892061|NCT00527319|OG001|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
10892062|NCT00527319|OG002|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
10892063|NCT00527319|EG000|Reported Event|Group A, Control Group|Supportive care only
10892064|NCT00527319|EG001|Reported Event|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
10892065|NCT00527319|EG002|Reported Event|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
10892066|NCT00527332|BG000|Baseline|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
10892067|NCT00527332|BG001|Baseline|General Anesthesia|General anesthesia
10892068|NCT00527332|BG002|Baseline|Total|Total of all reporting groups
10892069|NCT00527332|FG000|Participant Flow|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
10892070|NCT00527332|FG001|Participant Flow|General Anesthesia|General anesthesia
10892071|NCT00527332|OG000|Outcome|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.
10892072|NCT00527332|OG001|Outcome|General Anesthesia|General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
10892073|NCT00527332|EG000|Reported Event|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
10892074|NCT00527332|EG001|Reported Event|General Anesthesia|General anesthesia
10892075|NCT00527397|BG000|Baseline|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
10892076|NCT00527397|FG000|Participant Flow|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
10892077|NCT00527397|OG000|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
10892078|NCT00527397|OG001|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
10892079|NCT00527397|OG002|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
10892080|NCT00527397|OG000|Outcome|All Subjects|subjects treated with inhaled insulin
10892081|NCT00527397|EG000|Reported Event|All Subjects With Type 1 or Type 2 Diabetes Mellitus|all subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
11233202|NCT02424799|BG002|Baseline|Part B-Placebo|CU participants received matching placebo treatment to an area of 10% BSA (5% BSA on each arm, n=1) or 3.5% BSA (spread over the 2 arms, n=2) on days 1, 2 and 3.
11090195|NCT01527487|EG000|Reported Event|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Eribulin: 1.4 mg/m2 IV (Days 1 & 8), given short (≤15 minute) IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard."
11233203|NCT02424799|BG003|Baseline|Part B GSK2646264 1%|CU participants received 1% strength GSK2646264 to an area of 10% BSA (5% BSA on each arm, n=3) or 3% BSA (spread over the 2 arms, n=6) on days 1, 2 and 3.
11233204|NCT02424799|BG004|Baseline|Part C-Placebo|CSU participants received matching placebo treatment to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
10892082|NCT00527423|BG000|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
10892083|NCT00527423|FG000|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
10892084|NCT00527423|OG000|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
10892085|NCT00527423|OG000|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152 (end of treatment), and a 4-week follow-up visit at week 156 (end of study). Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
10892086|NCT00527423|OG000|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
10892087|NCT00527423|EG000|Reported Event|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
10892088|NCT00527475|BG000|Baseline|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
10892089|NCT00527475|BG001|Baseline|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
10892090|NCT00527475|BG002|Baseline|Total|Total of all reporting groups
10892091|NCT00527475|FG000|Participant Flow|Ranibizumab|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
10892092|NCT00527475|FG001|Participant Flow|Reduced Fluence PDT & Ranibizumab|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
10892093|NCT00527475|OG000|Outcome|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
10892094|NCT00527475|OG001|Outcome|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
10892095|NCT00527475|EG000|Reported Event|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
10892096|NCT00527475|EG001|Reported Event|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
10892097|NCT00527488|BG000|Baseline|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
10892098|NCT00527488|BG001|Baseline|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
10892099|NCT00527488|BG002|Baseline|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
10892100|NCT00527488|BG003|Baseline|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
10892101|NCT00527488|BG004|Baseline|Total|Total of all reporting groups
10892102|NCT00527488|FG000|Participant Flow|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
10892103|NCT00527488|FG001|Participant Flow|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
10892104|NCT00527488|FG002|Participant Flow|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
10892105|NCT00527488|FG003|Participant Flow|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
10892106|NCT00527488|OG000|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
10892107|NCT00527488|OG001|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
10892108|NCT00527488|OG002|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
11233205|NCT02424799|BG005|Baseline|Part C GSK2646264 1%|CSU participants received 1% strength GSK2646264 to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
10892109|NCT00527488|OG003|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
10892110|NCT00527488|EG000|Reported Event|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
10892111|NCT00527488|EG001|Reported Event|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
10892112|NCT00527488|EG002|Reported Event|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
10892113|NCT00527488|EG003|Reported Event|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
10892114|NCT00527514|BG000|Baseline|Amlodipine and Olmesartan, if Necessary|Week 1-3 all participants: Amlodipine 5mg; Week 4-6 Amlodipine 5 mg/olmesartan 20 mg if mean SBP >= 120/80 mm Hg; Week 7-9 Amlodipine 5 mg/ olmesartan 40 mg if mean SBP >= 120/80 mm Hg; Week 10-12 Amlodipine 10 mg/olmesartan 40 mg if mean SBP >= 120/80 mm Hg
10892115|NCT00527514|FG000|Participant Flow|Amlodipine and Olmesartan, if Necessary|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
10892116|NCT00527514|OG000|Outcome|Overall Active Treatment Period|
10892117|NCT00527514|OG000|Outcome|Group 1 Amlodipine 5 mg|All participants started the Active Treatment period with 5 mg of amlodipine for 3 weeks.
10892118|NCT00527514|OG000|Outcome|Group 2 - Aml 5 mg + Olmesartan 20 mg|Participants from Group 1 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 20 mg.
10892119|NCT00527514|OG000|Outcome|Group 3 - Aml 5 mg + Olm 40 mg|Participants from Group 2 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 40mg.
10892120|NCT00527514|OG000|Outcome|Group 4 - Aml 10 mg + Olm 40 mg|
10892121|NCT00527514|EG000|Reported Event|Amlodipine 5 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
10892122|NCT00527514|EG001|Reported Event|Amlodipine 5mg and Olmesartan 20 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
10892123|NCT00527514|EG002|Reported Event|Amlodipine 5mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
10892124|NCT00527514|EG003|Reported Event|Amlodipine 10 mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
10892125|NCT00527566|BG000|Baseline|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
10892126|NCT00527566|FG000|Participant Flow|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
10892127|NCT00527566|OG000|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
10892128|NCT00527566|OG000|Outcome|Mepolizumab (Treatment Phase)|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
10892129|NCT00527566|OG001|Outcome|Non-treatment Phase|The non-treatment phase consists of the wash-out phase and the safety monitoring phase.
10892130|NCT00527566|EG000|Reported Event|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
10892131|NCT00527592|BG000|Baseline|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
10892132|NCT00527592|FG000|Participant Flow|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
10892133|NCT00527592|OG000|Outcome|Travoprost|One drop in the study eye, single dose
10892134|NCT00527592|OG001|Outcome|Latanoprost|One drop in the study eye, single dose
10892135|NCT00527592|EG000|Reported Event|Travoprost|One drop in the study eye, single dose
10892136|NCT00527592|EG001|Reported Event|Latanoprost|One drop in the study eye, single dose
10892137|NCT00527605|BG000|Baseline|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
10892138|NCT00527605|BG001|Baseline|Placebo|Matching oral placebo once a day for 6 months
10892139|NCT00527605|BG002|Baseline|Total|Total of all reporting groups
10892140|NCT00527605|FG000|Participant Flow|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
10892141|NCT00527605|FG001|Participant Flow|Placebo|Matching oral placebo once a day for 6 months
10892142|NCT00527605|OG000|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
10892143|NCT00527605|OG001|Outcome|Placebo|Matching oral placebo once a day for 6 months
10892144|NCT00527605|EG000|Reported Event|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
10892145|NCT00527605|EG001|Reported Event|Placebo|Matching oral placebo once a day for 6 months
10892146|NCT00527618|BG000|Baseline|Entire Study Population|This includes all 34 participants who were randomized. A subset of 28 participants were included in the analysis since only 28 participants contributed samples on both arms of the crossover study.
10892147|NCT00527618|FG000|Participant Flow|Acyclovir Followed by Valacyclovir|Acyclovir 400 mg twice daily, followed by a two-week washout period, then valacyclovir 1000 mg twice daily
10892148|NCT00527618|FG001|Participant Flow|Valacyclovir Followed by Acyclovir|Valacyclovir 1000 mg twice daily, followed by a two-week washout period, then acyclovir 400 mg twice daily
10892149|NCT00527618|OG000|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
10892150|NCT00527618|OG001|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
10892151|NCT00527618|OG000|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily
10892152|NCT00527618|EG000|Reported Event|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
11233206|NCT02424799|BG006|Baseline|Total|Total of all reporting groups
10892153|NCT00527618|EG001|Reported Event|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
10892154|NCT00527644|BG000|Baseline|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
10892155|NCT00527644|FG000|Participant Flow|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
10892156|NCT00527644|OG000|Outcome|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
10892157|NCT00527644|EG000|Reported Event|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
10892158|NCT00527722|BG000|Baseline|Pleural Plug|Experimental lung plug after the lung biopsy.
10892159|NCT00527722|BG001|Baseline|No Pleural Plug|The standard lung biopsy without placement of the plug.
10892160|NCT00527722|BG002|Baseline|Total|Total of all reporting groups
10892161|NCT00527722|FG000|Participant Flow|Pleural Plug|Experimental lung plug after the lung biopsy.
10892162|NCT00527722|FG001|Participant Flow|No Pleural Plug|The standard lung biopsy without placement of the plug.
10892163|NCT00527722|OG000|Outcome|Pleural Plug|Experimental lung plug after the lung biopsy.
10892164|NCT00527722|OG001|Outcome|No Pleural Plug|The standard lung biopsy without placement of the plug.
10892165|NCT00527722|EG000|Reported Event|Pleural Plug|Experimental lung plug after the lung biopsy.
10892166|NCT00527722|EG001|Reported Event|No Pleural Plug|The standard lung biopsy without placement of the plug.
10892167|NCT00527735|BG000|Baseline|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892168|NCT00527735|BG001|Baseline|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892169|NCT00527735|BG002|Baseline|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
11090196|NCT01527487|EG001|Reported Event|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.~Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
10892170|NCT00527735|BG003|Baseline|Total|Total of all reporting groups
10892171|NCT00527735|FG000|Participant Flow|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892172|NCT00527735|FG001|Participant Flow|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892173|NCT00527735|FG002|Participant Flow|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
10892174|NCT00527735|OG000|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892175|NCT00527735|OG001|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892176|NCT00527735|OG002|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
10892177|NCT00527735|OG000|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892178|NCT00527735|OG001|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892179|NCT00527735|OG001|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892180|NCT00527735|OG000|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892181|NCT00527735|OG001|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892182|NCT00527735|OG001|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
11090197|NCT01527500|BG000|Baseline|Part A- LFG316 5 mg|LFG316 5 mg injection every 28 days for a total of 12 injections
10892183|NCT00527735|OG001|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892184|NCT00527735|OG000|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
10892185|NCT00527735|OG001|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
10892186|NCT00527735|EG000|Reported Event|Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC|During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892187|NCT00527735|EG001|Reported Event|Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC|During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892188|NCT00527735|EG002|Reported Event|Placebo + Paclitaxel/Carboplatin NSCLC|During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
10892189|NCT00527735|EG003|Reported Event|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC|During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
10892190|NCT00527735|EG004|Reported Event|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC|During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
11090198|NCT01527500|BG001|Baseline|Part A- Sham|sham injection every 28 days for a total of 12 injections
11090199|NCT01527500|BG002|Baseline|Part B- LFG316 10 mg|Single LFG316 10 mg Injection
11090200|NCT01527500|BG003|Baseline|Part B- Sham|Single Sham injection
11090201|NCT01527500|BG004|Baseline|Total|Total of all reporting groups
11090202|NCT01527500|FG000|Participant Flow|LFG316|
11090203|NCT01527500|FG001|Participant Flow|Sham|
11090204|NCT01527500|OG000|Outcome|LFG316|LFG316 (5 mg/50 µL)
11090205|NCT01527500|OG001|Outcome|Sham|Sham injection
11090206|NCT01527500|OG001|Outcome|Sham|Sham Injection
11090207|NCT01527500|OG001|Outcome|Sham|
11090208|NCT01527500|OG002|Outcome|LFG316 5 Mg-Sham|Difference in mean between LFG316 arm and Sham arm.
11090209|NCT01527500|OG000|Outcome|LFG316|LFG316 (10 mg/100 µL)
11090210|NCT01527500|OG000|Outcome|Part A - LFG316 5mg|Part A - LFG316 5 mg/50 µL injection every 4 weeks for 18 months
11090211|NCT01527500|OG001|Outcome|Sham - Part A|sham injection every 4 weeks for a total of 18 injections
10892191|NCT00527735|EG005|Reported Event|Placebo + Paclitaxel/Carboplatin SCLC|During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
10892192|NCT00527787|BG000|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
10892193|NCT00527787|BG001|Baseline|Naproxen|Naproxen 500 mg
10892194|NCT00527787|BG002|Baseline|Total|Total of all reporting groups
10892195|NCT00527787|FG000|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
10892196|NCT00527787|FG001|Participant Flow|Naproxen|Naproxen 500 mg
10892197|NCT00527787|OG000|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
10892198|NCT00527787|OG001|Outcome|Naproxen|Naproxen 500 mg
10892199|NCT00527787|EG000|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
10892200|NCT00527787|EG001|Reported Event|Naproxen|Naproxen 500 mg
10892201|NCT00527826|BG000|Baseline|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
10892202|NCT00527826|BG001|Baseline|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
10892203|NCT00527826|BG002|Baseline|Total|Total of all reporting groups
10892204|NCT00527826|FG000|Participant Flow|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
10892205|NCT00527826|FG001|Participant Flow|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
10892206|NCT00527826|OG000|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
10892207|NCT00527826|OG001|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
10892208|NCT00527826|OG001|Outcome|Sal 50 µg|Salmeterol xinafoate (Sal) 50 µg BID (morning and evening) from a separate inhaler (SEVERENT Diskus)
10892209|NCT00527826|OG002|Outcome|FP 500 µg|Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
10892210|NCT00527826|OG002|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
11090212|NCT01527500|OG002|Outcome|Part B - LFG316 10mg|Part B - LFG316 10 mg/100 µL injection every 4 weeks for 18 months
11090213|NCT01527500|OG003|Outcome|Sham - Part B|Single sham injection
11090214|NCT01527500|EG000|Reported Event|Part A - LFG316 5mg|Part A - LFG316 5 mg/50 µL injection every 4 weeks for 18 months
11090215|NCT01527500|EG001|Reported Event|Part A - Sham|sham injection every 4 weeks for a total of 18 injections
11090216|NCT01527500|EG002|Reported Event|Part B - LFG316 10mg|Part B - Single LFG316 10 mg/100 µL injection
11090217|NCT01527500|EG003|Reported Event|Part B - Sham|single sham injection
10892211|NCT00527826|EG000|Reported Event|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
10892212|NCT00527826|EG001|Reported Event|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
10892213|NCT00527878|BG000|Baseline|Patients|
10892214|NCT00527878|FG000|Participant Flow|Placebo/Ranitidine|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive placebo for 12 months followed by 12 months of the ranitidine.
10892215|NCT00527878|FG001|Participant Flow|Ranitidine/Placebo|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive ranitidine for 12 months followed by 12 months of the ranitidine.
11090218|NCT01527513|BG000|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
10892216|NCT00527878|OG000|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
10892217|NCT00527878|OG001|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
10892218|NCT00527878|EG000|Reported Event|Placebo|this was a crossover study and patients received both placebo and study drug (ranitidine), both of which for 12 months, unless they terminated the study.
10892219|NCT00527878|EG001|Reported Event|Ranitidine|This was a crossover study and patients received 12 months of ranitidine and 12 months of placebo, unless they terminated the study.
10892220|NCT00527904|BG000|Baseline|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
10892221|NCT00527904|FG000|Participant Flow|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
10892222|NCT00527904|OG000|Outcome|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
11090219|NCT01527513|BG001|Baseline|Placebo|Placebo QD
11090220|NCT01527513|BG002|Baseline|Total|Total of all reporting groups
11090221|NCT01527513|FG000|Participant Flow|Placebo|Placebo Once-Daily (QD)
10892223|NCT00527904|EG000|Reported Event|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
10892224|NCT00527943|BG000|Baseline|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
10892225|NCT00527943|BG001|Baseline|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
10892226|NCT00527943|BG002|Baseline|Total|Total of all reporting groups
10892227|NCT00527943|FG000|Participant Flow|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
10892228|NCT00527943|FG001|Participant Flow|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
10892229|NCT00527943|OG000|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
10892230|NCT00527943|OG001|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
10892231|NCT00527943|EG000|Reported Event|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
10892232|NCT00527943|EG001|Reported Event|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
11090222|NCT01527513|FG001|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 10-30 mg/kg/day QD (maximum 1200 mg/day).
10892250|NCT00528112|BG000|Baseline|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
10892251|NCT00528112|BG001|Baseline|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
10892252|NCT00528112|BG002|Baseline|Total|Total of all reporting groups
10892253|NCT00528112|FG000|Participant Flow|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
10892254|NCT00528112|FG001|Participant Flow|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
10892255|NCT00528112|OG000|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
11090223|NCT01527513|OG000|Outcome|Placebo|Placebo QD
10892256|NCT00528112|OG001|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
10892257|NCT00528112|OG000|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
10892258|NCT00528112|EG000|Reported Event|LCS12, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
10892259|NCT00528112|EG001|Reported Event|LCS16, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years.
10892260|NCT00528112|EG002|Reported Event|LCS16, up to 5 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
10892261|NCT00528190|BG000|Baseline|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
10892262|NCT00528190|BG001|Baseline|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
10892263|NCT00528190|BG002|Baseline|Total|Total of all reporting groups
10892264|NCT00528190|FG000|Participant Flow|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
10892265|NCT00528190|FG001|Participant Flow|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
10892266|NCT00528190|OG000|Outcome|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
10892267|NCT00528190|OG001|Outcome|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
10892268|NCT00528190|EG000|Reported Event|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
10892269|NCT00528190|EG001|Reported Event|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
10892270|NCT00528268|BG000|Baseline|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
10892271|NCT00528268|BG001|Baseline|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
10892272|NCT00528268|BG002|Baseline|Total|Total of all reporting groups
10892273|NCT00528268|FG000|Participant Flow|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
10892274|NCT00528268|FG001|Participant Flow|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
10892275|NCT00528268|OG000|Outcome|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
10892276|NCT00528268|OG001|Outcome|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
10892277|NCT00528268|EG000|Reported Event|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
10892278|NCT00528268|EG001|Reported Event|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
10892279|NCT00528372|BG000|Baseline|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892280|NCT00528372|BG001|Baseline|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
11090224|NCT01527513|OG001|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
11090225|NCT01527513|OG000|Outcome|Esl PART II|Eslicarbazepine acetate (ESL) 10-30 mg/kg/day QD (maximum 1200 mg/day).
11090226|NCT01527513|EG000|Reported Event|Placebo|Placebo QD
11090227|NCT01527513|EG001|Reported Event|Part I - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
10892281|NCT00528372|BG002|Baseline|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892282|NCT00528372|BG003|Baseline|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892283|NCT00528372|BG004|Baseline|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892284|NCT00528372|BG005|Baseline|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892285|NCT00528372|BG006|Baseline|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892286|NCT00528372|BG007|Baseline|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892287|NCT00528372|BG008|Baseline|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892288|NCT00528372|BG009|Baseline|Total|Total of all reporting groups
11090228|NCT01527513|EG002|Reported Event|Part II - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
10892289|NCT00528372|FG000|Participant Flow|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892290|NCT00528372|FG001|Participant Flow|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892291|NCT00528372|FG002|Participant Flow|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892292|NCT00528372|FG003|Participant Flow|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892293|NCT00528372|FG004|Participant Flow|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892294|NCT00528372|FG005|Participant Flow|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892295|NCT00528372|FG006|Participant Flow|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892296|NCT00528372|FG007|Participant Flow|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
11171248|NCT02001987|EG002|Reported Event|TCZ - All Participants|Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks. Participants who completed the core study period were allowed to enter a LTE period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
10892297|NCT00528372|FG008|Participant Flow|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892298|NCT00528372|OG000|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892299|NCT00528372|OG001|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892300|NCT00528372|OG002|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892301|NCT00528372|OG003|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892302|NCT00528372|OG004|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892303|NCT00528372|OG005|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892304|NCT00528372|OG006|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
11171249|NCT02002091|BG000|Baseline|Men Population|Screening for all chronic complications were performed for men. A non specific multi interventional treatment is applied to patients, as lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin) treatment of comorbidity or complications of diabetes as soon as the patients are recruited.
10892305|NCT00528372|OG001|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892306|NCT00528372|OG002|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892307|NCT00528372|OG003|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892308|NCT00528372|OG000|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892309|NCT00528372|OG001|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892310|NCT00528372|OG000|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892311|NCT00528372|OG000|Outcome|Group 1: Dapagliflozin Placebo AM & PM|"Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892312|NCT00528372|OG001|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892313|NCT00528372|OG002|Outcome|Group 1: Dapagliflozin, 5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892314|NCT00528372|OG003|Outcome|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892315|NCT00528372|OG001|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892316|NCT00528372|OG002|Outcome|Group 1: Dapaglifozon, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892317|NCT00528372|OG002|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892318|NCT00528372|OG000|Outcome|Group 1: Dapagliflozin Placebo, AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892319|NCT00528372|OG001|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892320|NCT00528372|OG002|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892321|NCT00528372|OG003|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
11090229|NCT01527682|BG000|Baseline|Latanoprost, Dorzolamide|"According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.~Latanoprost, Dorzolamide: - Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)~- Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost"
10892322|NCT00528372|OG004|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892323|NCT00528372|OG005|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892324|NCT00528372|OG006|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892325|NCT00528372|OG007|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892326|NCT00528372|OG008|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
10892327|NCT00528372|OG000|Outcome|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892328|NCT00528372|OG004|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, PM, once each evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892329|NCT00528372|OG005|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892330|NCT00528372|OG006|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892331|NCT00528372|OG004|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892332|NCT00528372|OG004|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892333|NCT00528372|OG005|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892334|NCT00528372|OG006|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892335|NCT00528372|EG000|Reported Event|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892336|NCT00528372|EG001|Reported Event|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892337|NCT00528372|EG002|Reported Event|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892338|NCT00528372|EG003|Reported Event|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
10892339|NCT00528372|EG004|Reported Event|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892340|NCT00528372|EG005|Reported Event|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892341|NCT00528372|EG006|Reported Event|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
10892342|NCT00528398|BG000|Baseline|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
10892343|NCT00528398|FG000|Participant Flow|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
10892344|NCT00528398|OG000|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
10892345|NCT00528398|EG000|Reported Event|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
11090230|NCT01527682|FG000|Participant Flow|Latanoprost, Dorzolamide|"According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.~Latanoprost, Dorzolamide: - Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)~- Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost"
10892346|NCT00528411|BG000|Baseline|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus Clopidogrel placebo loading and od maintenance doses
10892347|NCT00528411|BG001|Baseline|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
10892348|NCT00528411|BG002|Baseline|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
10892349|NCT00528411|BG003|Baseline|Total|Total of all reporting groups
10892350|NCT00528411|FG000|Participant Flow|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
10892351|NCT00528411|FG001|Participant Flow|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg Twice Daily (od), plus ticagrelor placebo loading and Once Daily (bd) maintenance doses
10892352|NCT00528411|FG002|Participant Flow|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
10892353|NCT00528411|OG000|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
10892354|NCT00528411|OG001|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
10892355|NCT00528411|OG002|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
10892356|NCT00528411|EG000|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
10892357|NCT00528411|EG001|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
10892358|NCT00528411|EG002|Reported Event|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
10892359|NCT00528424|BG000|Baseline|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
10892360|NCT00528424|FG000|Participant Flow|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892361|NCT00528424|OG000|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
10892362|NCT00528424|EG000|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892363|NCT00528450|BG000|Baseline|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
10892364|NCT00528450|FG000|Participant Flow|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
10892365|NCT00528450|OG000|Outcome|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
10892366|NCT00528450|EG000|Reported Event|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
10892367|NCT00528528|BG000|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892368|NCT00528528|BG001|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
10892369|NCT00528528|BG002|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892370|NCT00528528|BG003|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
10892371|NCT00528528|BG004|Baseline|Total|Total of all reporting groups
10892372|NCT00528528|FG000|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892373|NCT00528528|FG001|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
10892374|NCT00528528|FG002|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892375|NCT00528528|FG003|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
11090231|NCT01527682|OG000|Outcome|Latanoprost, Dorzolamide|"According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.~Latanoprost, Dorzolamide: - Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)~- Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost"
11090232|NCT01527682|EG000|Reported Event|Latanoprost / Dorzolamide|"According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.~Latanoprost, Dorzolamide: - Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)~- Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost"
10892376|NCT00528528|OG000|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892377|NCT00528528|OG001|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
10892378|NCT00528528|OG002|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892379|NCT00528528|OG003|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
10892380|NCT00528528|OG000|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892381|NCT00528528|OG001|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
10892382|NCT00528528|EG000|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892383|NCT00528528|EG001|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
10892384|NCT00528528|EG002|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
10892385|NCT00528528|EG003|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
10892386|NCT00528541|BG000|Baseline|BOTOX®|botulinum toxin type A (BOTOX®)
10892387|NCT00528541|BG001|Baseline|Dysport®|botulinum toxin type A (Dysport®)
10892388|NCT00528541|BG002|Baseline|Total|Total of all reporting groups
10892389|NCT00528541|FG000|Participant Flow|BOTOX®|botulinum toxin type A (BOTOX®)
10892390|NCT00528541|FG001|Participant Flow|Dysport®|botulinum toxin type A (Dysport®)
10892391|NCT00528541|OG000|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
10892392|NCT00528541|OG001|Outcome|Dysport®|botulinum toxin type A (Dysport®)
10892393|NCT00528541|EG000|Reported Event|BOTOX®|botulinum toxin type A (BOTOX®)
10892394|NCT00528541|EG001|Reported Event|Dysport®|botulinum toxin type A (Dysport®)
10892395|NCT00528567|BG000|Baseline|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
10892396|NCT00528567|BG001|Baseline|Chemotherapy|Participants randomized to receive chemotherapy alone
10892397|NCT00528567|BG002|Baseline|Total|Total of all reporting groups
10892398|NCT00528567|FG000|Participant Flow|Bevacizumab and Chemotherapy|"Participants randomized to receive bevacizumab and chemotherapy.~For these patients, bevacizumab was given in combination with chemotherapy at a dose of 5 mg/kg/week equivalent using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy selected. After completing chemotherapy + bevacizumab (treatment period 1), patients in this arm received bevacizumab monotherapy up to a total duration of 1 year (treatment period 2).~At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
10892399|NCT00528567|FG001|Participant Flow|Chemotherapy|"Participants randomized to receive chemotherapy alone.~For patients randomized to the chemotherapy alone arm, investigators could select from one of three chemotherapy regimens. After completing chemotherapy (treatment period 1) patients entered a post-treatment surveillance period for the remainder of the first year after randomization (treatment period 2).~At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
10892400|NCT00528567|OG000|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
10892401|NCT00528567|OG001|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
10892402|NCT00528567|OG001|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
10892403|NCT00528567|OG000|Outcome|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, 0-18 months after first dose
10892404|NCT00528567|OG001|Outcome|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, 0-18 months after first dose
11090233|NCT01528033|BG000|Baseline|NPWT|Negative Pressure Wound Therapy
11090234|NCT01528033|BG001|Baseline|SCWT|Standard Conventional Wound Treatment
11090235|NCT01528033|BG002|Baseline|Total|Total of all reporting groups
11171250|NCT02002091|BG001|Baseline|Women Population|Screening for all chronic complications were performed for women. A non specific multi interventional treatment is applied to patients, as lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes as soon as the patients are recruited.
10892405|NCT00528567|OG002|Outcome|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, more than 18 months after first dose
10892406|NCT00528567|OG003|Outcome|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, more than 18 months after first dose
10892407|NCT00528567|EG000|Reported Event|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during treatment period (0-18 months) after first dose
10892408|NCT00528567|EG001|Reported Event|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, during treatment period (0-18 months) after first dose
10892409|NCT00528567|EG002|Reported Event|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during follow-up period (>18 months) after first dose
10892410|NCT00528567|EG003|Reported Event|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, during follow-up period (>18 months) after first dose
10892411|NCT00528580|BG000|Baseline|Experimental|"Simvastatin 80 mg once daily PO (or via NG or G-tube)~Simvastatin: 80 mg once daily PO/NG x 4 days"
10892412|NCT00528580|BG001|Baseline|Placebo|"Identical-appearing placebo PO (or via NG or G-tube)~Identical-appearing placebo: once daily x 4 days"
10892413|NCT00528580|BG002|Baseline|Total|Total of all reporting groups
10892414|NCT00528580|FG000|Participant Flow|Experimental|"Simvastatin 80 mg once daily PO (or via NG or G-tube)~Simvastatin: 80 mg once daily PO/NG x 4 days"
10892415|NCT00528580|FG001|Participant Flow|Placebo|"Identical-appearing placebo PO (or via NG or G-tube)~Identical-appearing placebo: once daily x 4 days"
10892416|NCT00528580|OG000|Outcome|Treatment Group|"Simvastatin 80 mg once daily PO (or via NG or G-tube)~Simvastatin: 80 mg once daily PO/NG x 4 days"
10892417|NCT00528580|OG001|Outcome|Control Group|"Identical-appearing placebo PO (or via NG or G-tube)~Identical-appearing placebo: once daily x 4 days"
10892418|NCT00528580|EG000|Reported Event|Simvastatin|"Simvastatin 80 mg once daily PO (or via NG or G-tube)~Simvastatin: 80 mg once daily PO/NG x 4 days"
10892419|NCT00528580|EG001|Reported Event|Placebo|"Identical-appearing placebo PO (or via NG or G-tube)~Identical-appearing placebo: once daily x 4 days"
10892420|NCT00528606|BG000|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892421|NCT00528606|BG001|Baseline|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892422|NCT00528606|BG002|Baseline|Total|Total of all reporting groups
10892423|NCT00528606|FG000|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892424|NCT00528606|FG001|Participant Flow|Placebo|Placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892425|NCT00528606|OG000|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892426|NCT00528606|OG001|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892427|NCT00528606|EG000|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892428|NCT00528606|EG001|Reported Event|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892429|NCT00528645|BG000|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.~saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
10892430|NCT00528645|FG000|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
10892431|NCT00528645|OG000|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks"
10892432|NCT00528645|OG000|Outcome|Treatment (Saracatinib)|saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
10892433|NCT00528645|EG000|Reported Event|Treatment (Saracatinib)|saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
10892434|NCT00528788|BG000|Baseline|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol : 2 or 4 mcg"
10892435|NCT00528788|FG000|Participant Flow|Pre Doxercalciferol/Post Doxercalciferol|"all end stage renal disease patients with secondary hyperparathyroidism who are vitamin D naive~compared pre- and post doxercalciferol."
10892436|NCT00528788|OG000|Outcome|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol"
10892437|NCT00528788|EG000|Reported Event|Pre and Post Doxicalciferol|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol 2 mcg or 4 mcg three times per week for 1 month"
10892438|NCT00528801|BG000|Baseline|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
10892439|NCT00528801|BG001|Baseline|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
10892440|NCT00528801|BG002|Baseline|Total|Total of all reporting groups
10892441|NCT00528801|FG000|Participant Flow|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
10892442|NCT00528801|FG001|Participant Flow|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
10892443|NCT00528801|OG000|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
10892444|NCT00528801|OG001|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
10892445|NCT00528801|EG000|Reported Event|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
11171251|NCT02002091|BG002|Baseline|Total|Total of all reporting groups
10892446|NCT00528801|EG001|Reported Event|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
10892447|NCT00528840|BG000|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892448|NCT00528840|FG000|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892449|NCT00528840|OG000|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892450|NCT00528840|EG000|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10892451|NCT00528866|BG000|Baseline|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
10892452|NCT00528866|FG000|Participant Flow|Androgen Suppression + RT + Docetaxel|Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
10892453|NCT00528866|OG000|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
10892454|NCT00528866|OG000|Outcome|Androgen Suppression + RT + Docetaxel|Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
10892455|NCT00528866|EG000|Reported Event|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
10892456|NCT00528879|BG000|Baseline|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892457|NCT00528879|BG001|Baseline|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892458|NCT00528879|BG002|Baseline|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892459|NCT00528879|BG003|Baseline|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892460|NCT00528879|BG004|Baseline|Total|Total of all reporting groups
10892461|NCT00528879|FG000|Participant Flow|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892462|NCT00528879|FG001|Participant Flow|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892463|NCT00528879|FG002|Participant Flow|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892464|NCT00528879|FG003|Participant Flow|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892465|NCT00528879|OG000|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892466|NCT00528879|OG001|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892467|NCT00528879|OG002|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892468|NCT00528879|OG003|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892469|NCT00528879|EG000|Reported Event|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
11090236|NCT01528033|FG000|Participant Flow|Vacuum Assisted Closure®|"Negative pressure wound therapy~Vacuum Assisted Closure®: Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days.~VAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the study site.~Systems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended."
11090237|NCT01528033|FG001|Participant Flow|Standard Conventional Wound Therapy|"According to institutional clinical standards~Standard conventional wound therapy: Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days"
11090238|NCT01528033|OG000|Outcome|NPWT|Negative Pressure Wound Therapy
11090239|NCT01528033|OG001|Outcome|SCWT|Standard Conventional Wound Treatment
11090240|NCT01528033|EG000|Reported Event|NPWT|Negative Pressure Wound Therapy
10892470|NCT00528879|EG001|Reported Event|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892471|NCT00528879|EG002|Reported Event|Dapagliflozin, 5.0 mg + Metformin|Participants received dapagliflozin, 5.0 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892472|NCT00528879|EG003|Reported Event|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
10892473|NCT00528931|BG000|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
10892474|NCT00528931|FG000|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
10892475|NCT00528931|OG000|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
10892476|NCT00528931|OG000|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
10892477|NCT00528931|EG000|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
10892478|NCT00528957|BG000|Baseline|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
10892479|NCT00528957|BG001|Baseline|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
10892480|NCT00528957|BG002|Baseline|Total|Total of all reporting groups
10892481|NCT00528957|FG000|Participant Flow|Tenofovir DF|Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
10892482|NCT00528957|FG001|Participant Flow|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
10892483|NCT00528957|OG000|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
10892484|NCT00528957|OG001|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
10892485|NCT00528957|OG002|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
11090241|NCT01528033|EG001|Reported Event|SCWT|Standard Conventional Wound Treatment
11090242|NCT01528072|BG000|Baseline|Dynesys System|Dynesys Spinal System will be used for all subjects
11090243|NCT01528072|FG000|Participant Flow|Dynesys System|Dynesys Spinal System will be used for all subjects
10892486|NCT00528957|OG000|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
11090244|NCT01528072|OG000|Outcome|Dynesys System|Dynesys Spinal System will be used for all subjects.
11090245|NCT01528072|EG000|Reported Event|Dynesys System|Dynesys Spinal System: Dynesys Spinal System will be used for all subjects
11090246|NCT01528124|BG000|Baseline|Placebo|Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
11090247|NCT01528124|BG001|Baseline|0.15 mg LY3025876|0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
11090248|NCT01528124|BG002|Baseline|0.5 mg LY3025876|0.5 mg LY3025876 administered as subcutaneous injection
11090249|NCT01528124|BG003|Baseline|1.5 mg LY3025876|1.5 mg LY3025876 administered as subcutaneous injection
11090250|NCT01528124|BG004|Baseline|5 mg LY3025876|5 mg LY3025876 administered as subcutaneous injection
10892487|NCT00528957|OG001|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
10892488|NCT00528957|OG000|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
10892489|NCT00528957|OG002|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases (All TDF group)
10892490|NCT00528957|OG002|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
10892491|NCT00528957|OG001|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
10892492|NCT00528957|OG000|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
10892493|NCT00528957|OG001|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
10892494|NCT00528957|EG000|Reported Event|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
10892495|NCT00528957|EG001|Reported Event|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
10892496|NCT00528957|EG002|Reported Event|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
10892497|NCT00528970|BG000|Baseline|MOA-728 12 mg|Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892498|NCT00528970|BG001|Baseline|MOA-728 24 mg|Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892499|NCT00528970|BG002|Baseline|Placebo|Participants received placebo matched to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
11090251|NCT01528124|BG005|Baseline|15 mg LY3025876|15 mg LY3025876 administered as subcutaneous injection
11090252|NCT01528124|BG006|Baseline|30 mg LY3025876|30 mg LY3025876 administered as subcutaneous injection
10892500|NCT00528970|BG003|Baseline|Total|Total of all reporting groups
10892501|NCT00528970|FG000|Participant Flow|MOA-728 12 mg|Participants received methylnaltrexone (MOA-728) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892502|NCT00528970|FG001|Participant Flow|MOA-728 24 mg|Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892503|NCT00528970|FG002|Participant Flow|Placebo|Participants received placebo matched to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892504|NCT00528970|OG000|Outcome|MOA-728 12 mg|Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892505|NCT00528970|OG001|Outcome|MOA-728 24 mg|Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892506|NCT00528970|OG002|Outcome|Placebo|Participants received placebo matched to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892507|NCT00528970|EG000|Reported Event|MOA-728 12 mg|Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892508|NCT00528970|EG001|Reported Event|MOA-728 24 mg|Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892509|NCT00528970|EG002|Reported Event|Placebo|Participants received placebo matched to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
10892510|NCT00528996|BG000|Baseline|Placebo|Oral inhalation of solution of Placebo matching BEA 2180 BR was administered once daily via Respimat® inhaler for 24 weeks.
10892511|NCT00528996|BG001|Baseline|BEA 2180 BR 50 Microgram (mcg)|2 oral inhalations of solution of 25 micrograms (mcg) of BEA 2180 BR (total: 50 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892512|NCT00528996|BG002|Baseline|BEA 2180 BR 100 Microgram (mcg)|2 oral inhalations of solution of 50 micrograms (mcg) of BEA 2180 BR (total: 100 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892513|NCT00528996|BG003|Baseline|BEA 2180 BR 200 Microgram (mcg)|2 oral inhalations of solution of 100 micrograms (mcg) of BEA 2180 BR (total: 200 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892514|NCT00528996|BG004|Baseline|Tiotropium Bromide 5 Microgram (mcg)|2 inhalation of solution of 2.5 micrograms (mcg) of Tiotropium Bromide (total: 5 mcg) were administered orally via Respimat® inhaler once daily for 24 weeks.
10892515|NCT00528996|BG005|Baseline|Total|Total of all reporting groups
10892516|NCT00528996|FG000|Participant Flow|Placebo|Oral inhalation of solution of Placebo matching BEA 2180 BR was administered once daily via Respimat® inhaler for 24 weeks.
10892517|NCT00528996|FG001|Participant Flow|BEA 2180 BR 50 Microgram (mcg)|2 oral inhalations of solution of 25 micrograms (mcg) of BEA 2180 BR (total: 50 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892518|NCT00528996|FG002|Participant Flow|BEA 2180 BR 100 Microgram (mcg)|2 oral inhalations of solution of 50 micrograms (mcg) of BEA 2180 BR (total: 100 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892519|NCT00528996|FG003|Participant Flow|BEA 2180 BR 200 Microgram (mcg)|2 oral inhalations of solution of 100 micrograms (mcg) of BEA 2180 BR (total: 200 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892520|NCT00528996|FG004|Participant Flow|Tiotropium Bromide 5 Microgram (mcg)|2 inhalation of solution of 2.5 micrograms (mcg) of Tiotropium Bromide (total: 5 mcg) were administered orally via Respimat® inhaler once daily for 24 weeks.
10892521|NCT00528996|OG000|Outcome|Placebo|Oral inhalation of solution of Placebo matching BEA 2180 BR was administered once daily via Respimat® inhaler for 24 weeks.
10892522|NCT00528996|OG001|Outcome|BEA 2180 BR 50 Microgram (mcg)|2 oral inhalations of solution of 25 micrograms (mcg) of BEA 2180 BR (total: 50 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892523|NCT00528996|OG002|Outcome|BEA 2180 BR 100 Microgram (mcg)|2 oral inhalations of solution of 50 micrograms (mcg) of BEA 2180 BR (total: 100 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892524|NCT00528996|OG003|Outcome|BEA 2180 BR 200 Microgram (mcg)|2 oral inhalations of solution of 100 micrograms (mcg) of BEA 2180 BR (total: 200 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892525|NCT00528996|OG004|Outcome|Tiotropium Bromide 5 Microgram (mcg)|2 inhalation of solution of 2.5 micrograms (mcg) of Tiotropium Bromide (total: 5 mcg) were administered orally via Respimat® inhaler once daily for 24 weeks.
10892526|NCT00528996|OG001|Outcome|BEA 2180 BR Inhalation Solution 50 Microgram (mcg)|Inhalation of solution of 50 microgram (mcg) BEA 1280 BR (2 inhalations via Respimat® inhaler x 25 mcg) for oral inhalation once daily for 24 weeks.
10892527|NCT00528996|OG002|Outcome|BEA 2180 BR Inhalation Solution 100 Microgram (mcg)|Inhalation of solution of 100 microgram (mcg) BEA 1280 BR (2 inhalations viaRespimat® inhaler x 50 mcg) for oral inhalation once daily for 24 weeks.
10892528|NCT00528996|OG003|Outcome|BEA 2180 BR Inhalation Solution 200 Microgram (mcg)|Inhalation of solution of 200 microgram (mcg) BEA 1280 BR (2 inhalations viaRespimat® inhaler x 100 mcg) for oral inhalation once daily for 24 weeks.
10892529|NCT00528996|EG000|Reported Event|Placebo|Oral inhalation of solution of Placebo matching BEA 2180 BR was administered once daily via Respimat® inhaler for 24 weeks.
10892530|NCT00528996|EG001|Reported Event|BEA 2180 BR 50 Microgram (mcg)|2 oral inhalations of solution of 25 micrograms (mcg) of BEA 2180 BR (total: 50 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892531|NCT00528996|EG002|Reported Event|BEA 2180 BR 100 Microgram (mcg)|2 oral inhalations of solution of 50 micrograms (mcg) of BEA 2180 BR (total: 100 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
10892532|NCT00528996|EG003|Reported Event|BEA 2180 BR 200 Microgram (mcg)|2 oral inhalations of solution of 100 micrograms (mcg) of BEA 2180 BR (total: 200 mcg) were administered via Respimat® inhaler once daily for 24 weeks.
11171252|NCT02002091|FG000|Participant Flow|Complications' Assessment for Men|122 patients had a complete clinical examination, we realized an electrocardiogram, some biological exams for glycemic, hepatical, hematological and inflammatory status. We performed, in assessing macroangiopathy, an echocardiography, a vascular ultrasonography, a cardiac stress testing ( myocardial scintigraphy or stress electrocardiogram), a coronaroangiography if indicated and a cerebral scanner in case of suspicion of stroke. For the assessment of microangiopathy, we practiced a fundoscopy, a neurological examination to screen for peripheral neuropathy in all patients, we performed the Ewing tests for cardiac autonomic neuropathy , post voiding residual for diabetic cystopathy, a manocystometry if indicated and evaluated the renal status (ACR, creatininemia, uro-nephrological echography) in all patients.
11233207|NCT02424799|FG000|Participant Flow|Part A-GSK2646264 0.5% and Placebo|Participants were treated topically with 0.5 % GSK2646264 cream and placebo cream on an area of approximately 12 x 3 centimeter (cm) on the volar aspect of the arm which approximated to 0.2% total body surface area (BSA), on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
10892533|NCT00528996|EG004|Reported Event|Tiotropium Bromide 5 Microgram (mcg)|2 inhalation of solution of 2.5 micrograms (mcg) of Tiotropium Bromide (total: 5 mcg) were administered orally via Respimat® inhaler once daily for 24 weeks.
10892534|NCT00529035|BG000|Baseline|Group 1|"Interleukin-2 (IL-2) will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels:~Dose Level -A 0.3 x 106 (IU/m2/d) Dose Level -B 1 x 106 (IU/m2/d) Dose Level-C 3 x 106 (IU/m2/d)"
10892535|NCT00529035|FG000|Participant Flow|Ultra-low Dose Interleukin-2|"Daily subcutaneous administration of Interleukin-2 evaluated at three dose levels:~Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/M^2/day"
10892536|NCT00529035|OG000|Outcome|Ultra-low Dose IL-2 MTD|
10892537|NCT00529035|OG000|Outcome|Ultra-low Dose Interleukin-2|
10892538|NCT00529035|OG000|Outcome|Median Absolute Cell Counts at Baseline|Immune-cell counts before the start of IL-2 therapy
10892539|NCT00529035|OG001|Outcome|Median Absolute Cell Counts at Week 8|Immune-cell counts after 8 weeks of IL-2 therapy
10892540|NCT00529035|OG002|Outcome|Median Absolute Cell Count at Week 12|Immune-cell counts after a 4 weeks off IL-2 per protocol
10892541|NCT00529035|OG000|Outcome|Median Treg:Tcon Ratio at Baseline|Immune-cell ratio before the start of IL-2 therapy
10892542|NCT00529035|OG001|Outcome|Median Treg:Tcon Ratio at Week 8|Immune-cell ratio after 8 weeks of IL-2 therapy
10892543|NCT00529035|OG002|Outcome|Median Treg:Tcon Ratio at Week 12|Immune-cell ratio after a 4 weeks off IL-2 per protocol
10892544|NCT00529035|EG000|Reported Event|Ultra-low Dose Interleukin-2|"Interleukin-2 (IL-2) will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels:~Dose Level -A 0.3 x 106 (IU/m2/d) Dose Level -B 1 x 106 (IU/m2/d) Dose Level-C 3 x 106 (IU/m2/d)"
10892545|NCT00529087|BG000|Baseline|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
10892546|NCT00529087|BG001|Baseline|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
10892547|NCT00529087|BG002|Baseline|Placebo (Double-blind)|Once daily for weeks 1 through 4
10892548|NCT00529087|BG003|Baseline|Total|Total of all reporting groups
10892549|NCT00529087|FG000|Participant Flow|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
10892550|NCT00529087|FG001|Participant Flow|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
10892551|NCT00529087|FG002|Participant Flow|Placebo (Double-blind)|Once daily for weeks 1 through 4
10892552|NCT00529087|OG000|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 QD treatment group (12 mg every day) and MOA-728 QOD treatment group (12 mg once every other day, with placebo once daily on alternating days).
10892553|NCT00529087|OG001|Outcome|Placebo|Once daily
10892554|NCT00529087|OG000|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
10892555|NCT00529087|OG001|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), with placebo once daily on alternating days
10892556|NCT00529087|OG002|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
10892557|NCT00529087|OG003|Outcome|Placebo QD|Once daily
10892558|NCT00529087|OG000|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 12 mg once daily (QD) and MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
10892559|NCT00529087|OG001|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
10892560|NCT00529087|OG002|Outcome|Placebo|Once daily
10892561|NCT00529087|OG000|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
10892562|NCT00529087|OG001|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day, Placebo once daily on alternating days
10892563|NCT00529087|OG003|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
10892564|NCT00529087|EG000|Reported Event|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
10892565|NCT00529087|EG001|Reported Event|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
10892566|NCT00529087|EG002|Reported Event|Placebo (Double-blind)|Once daily for weeks 1 through 4
10892567|NCT00529087|EG003|Reported Event|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) for weeks 5 through 12
10892568|NCT00529100|BG000|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1|Participants were strictly in Phase 1. Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
10892569|NCT00529100|BG001|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1-Phase 2|Participants were overlap in Phase 1 and Phase 2.
10892570|NCT00529100|BG002|Baseline|Pemetrexed/Cisplatin/Radiation Phase 2|Participants were strictly in Phase 2. Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m2 IV.
10892571|NCT00529100|BG003|Baseline|Total|Total of all reporting groups
10892572|NCT00529100|FG000|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (every 3 weeks [q3 weeks]) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
10892573|NCT00529100|FG001|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
10892574|NCT00529100|OG000|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on days 1-5 and 22-26 for cohort four. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
10892575|NCT00529100|OG000|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed 500 mg/m^2 as determined by phase 1 trial on Days 1 and 22; concurrent cisplatin 20 mg/m^2 as determined by phase 1 trial with cycles commencing on Days 1 and 22; two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m2.
10892576|NCT00529100|OG000|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
10892577|NCT00529100|OG000|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
10892578|NCT00529100|OG000|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
11090253|NCT01528124|BG007|Baseline|Total|Total of all reporting groups
11090254|NCT01528124|FG000|Participant Flow|Placebo|Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
10892579|NCT00529100|EG000|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
10892580|NCT00529100|EG001|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1-2|"Cohort 4 data from Phase (Ph) 1 was included in the Ph 2 analysis as Cohort 4 was the established dose from Ph 1.~Ph 1: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first 3 cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.~Ph 2: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus from Ph 1 trial on Days 1 and 22; concurrent cisplatin from Ph 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2."
10892581|NCT00529100|EG002|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
10892582|NCT00529126|BG000|Baseline|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
10892583|NCT00529126|BG001|Baseline|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
10892584|NCT00529126|BG002|Baseline|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
10892585|NCT00529126|BG003|Baseline|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
10892586|NCT00529126|BG004|Baseline|Total|Total of all reporting groups
10892587|NCT00529126|FG000|Participant Flow|SKY0402 High Dose (300mg)|SKY0402 300mg single dose administered intraoperatively via local infiltration.
10892588|NCT00529126|FG001|Participant Flow|SKY0402 Middle Dose (225mg)|A single dose 225mg SKY0402 administered intraoperatively via local infiltration.
10892589|NCT00529126|FG002|Participant Flow|SKY0402 Low Dose (75mg)|A single dose 75mg SKY0402 administered intraoperatively via local infiltration.
10892590|NCT00529126|FG003|Participant Flow|Bupivacaine HCl 75mg|A single dose of 75 mg bupivacaine administered intraoperatively via local infiltration
10892591|NCT00529126|OG000|Outcome|SKY0402 300mg|A single dose of SKY0402 300mg administered intraoperatively via local infiltration.
10892592|NCT00529126|OG001|Outcome|SKY0402 225mg|A single dose of SKY0402 225mg administered intraoperatively via local infiltration.
10892593|NCT00529126|OG002|Outcome|SKY0402 75mg|A single dose of SKY0402 75mg administered intraoperatively via local infiltration.
10892594|NCT00529126|OG003|Outcome|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
10892595|NCT00529126|EG000|Reported Event|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
10892596|NCT00529126|EG001|Reported Event|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
10892597|NCT00529126|EG002|Reported Event|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
10892598|NCT00529126|EG003|Reported Event|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
10892599|NCT00529191|BG000|Baseline|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
10892600|NCT00529191|BG001|Baseline|Placebo|Placebo treatment
10892601|NCT00529191|BG002|Baseline|Total|Total of all reporting groups
10892602|NCT00529191|FG000|Participant Flow|Atorvastatin|Two out of every 3 patients will receive atorvastatin in tablet form. The subject will start on 10mg of atorvastatin daily for four weeks, and then titrate up to 20mg daily. There will be 12 months of treatment followed by 6 months of a washout period.
10892603|NCT00529191|FG001|Participant Flow|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
10892604|NCT00529191|OG000|Outcome|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
10892605|NCT00529191|OG001|Outcome|Placebo|Placebo treatment
10892606|NCT00529191|OG000|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
10892607|NCT00529191|OG001|Outcome|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
10892608|NCT00529191|OG001|Outcome|Placebo|"One out of three subjects will receive a placebo.~Placebo: One out of three subjects will receive a placebo."
10892609|NCT00529191|OG000|Outcome|Atorvastatin|"Participants in Atorvastatin arm who had hypoglycemic episodes requiring treatment~Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
10892610|NCT00529191|OG001|Outcome|Placebo|"Participants in placebo arm who had hypoglycemic episodes requiring treatment~Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period."
10892611|NCT00529191|OG000|Outcome|Atorvastatin NO Islet Cell Preservation|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
10892612|NCT00529191|OG001|Outcome|Placebo NO Islet Cell Preservation|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
10892613|NCT00529191|OG002|Outcome|Atorvastatin YES Islet Cell Preservation|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
10892614|NCT00529191|OG003|Outcome|Placebo YES Islet Cell Preservation|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
10892615|NCT00529191|EG000|Reported Event|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
10892616|NCT00529191|EG001|Reported Event|Placebo|Placebo treatment
10892617|NCT00529204|BG000|Baseline|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
10892618|NCT00529204|FG000|Participant Flow|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
10892619|NCT00529204|OG000|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
10892620|NCT00529204|EG000|Reported Event|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
10892621|NCT00529217|BG000|Baseline|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
10892622|NCT00529217|FG000|Participant Flow|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
10892623|NCT00529217|OG000|Outcome|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
10892624|NCT00529217|OG000|Outcome|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
10892625|NCT00529217|EG000|Reported Event|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
10892626|NCT00529243|BG000|Baseline|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
10892627|NCT00529243|FG000|Participant Flow|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
10892628|NCT00529243|OG000|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
10892629|NCT00529243|EG000|Reported Event|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
10892630|NCT00529308|BG000|Baseline|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
10892631|NCT00529308|BG001|Baseline|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
10892632|NCT00529308|BG002|Baseline|Total|Total of all reporting groups
10892633|NCT00529308|FG000|Participant Flow|Active rTMS|
10892634|NCT00529308|FG001|Participant Flow|Sham|
10892635|NCT00529308|OG000|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
10892636|NCT00529308|OG001|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
10892637|NCT00529308|EG000|Reported Event|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
10892638|NCT00529308|EG001|Reported Event|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
10892639|NCT00529373|BG000|Baseline|Odanacatib 50 mg OW|Participants received 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892640|NCT00529373|BG001|Baseline|Placebo|Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892641|NCT00529373|BG002|Baseline|Total|Total of all reporting groups
10892642|NCT00529373|FG000|Participant Flow|Odanacatib 50 mg OW|Participants received 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892643|NCT00529373|FG001|Participant Flow|Placebo|Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892644|NCT00529373|OG000|Outcome|Odanacatib 50 mg OW|Participants received 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892645|NCT00529373|OG001|Outcome|Placebo|Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892646|NCT00529373|OG001|Outcome|Placebo|Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892647|NCT00529373|OG001|Outcome|Placebo (Originally Assigned to Placebo)|Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892648|NCT00529373|OG001|Outcome|Placebo|Participants receive blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.
10892649|NCT00529373|OG000|Outcome|Odanacatib 50 mg OW|Participants received 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892650|NCT00529373|OG001|Outcome|Placebo|Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892651|NCT00529373|OG001|Outcome|Placebo|Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for 5 up to years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892652|NCT00529373|EG000|Reported Event|Base Study + First Extension: Odanacatib 50 mg OW|Participants received 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total). Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892653|NCT00529373|EG001|Reported Event|Base Study + First Extension: Placebo|Participants received blinded placebo to 10 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892654|NCT00529373|EG002|Reported Event|Second Extension: Odanacatib 50 mg OW|Participants received 50 mg of open-label odanacatib weekly for 5 years in the second extension study after having previously received 50 mg of blinded odanacatib weekly in the base study and first extension study (5 years total). Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892655|NCT00529373|EG003|Reported Event|Second Extension: Odanacatib 50 mg OW (Placebo)|Participants received 50 mg of open-label odanacatib weekly for 5 years in the second extension study after having previously received blinded placebo to 50 mg of odanacatib weekly in the base study and first extension study (5 years total). Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.
10892656|NCT00529386|BG000|Baseline|Botox|"300 IU botox~Botox: 300 units"
10892657|NCT00529386|FG000|Participant Flow|Botox|"300 IU botox~Botox: 300 units"
10892658|NCT00529386|OG000|Outcome|Botox|"300 IU botox~Botox: 300 units"
10892659|NCT00529386|EG000|Reported Event|Botox|"300 IU botox~Botox: 300 units"
10892660|NCT00529399|BG000|Baseline|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
10892661|NCT00529399|BG001|Baseline|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
10892662|NCT00529399|BG002|Baseline|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
10892663|NCT00529399|BG003|Baseline|Total|Total of all reporting groups
10892664|NCT00529399|FG000|Participant Flow|GAD-alum|"3 injections of Glutamic Acid Decarboxylase (GAD)-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
11090255|NCT01528124|FG001|Participant Flow|0.15 mg LY3025876|0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
11090256|NCT01528124|FG002|Participant Flow|0.5 mg LY3025876|0.5 mg LY3025876 administered as subcutaneous injection
10892665|NCT00529399|FG001|Participant Flow|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
10892666|NCT00529399|FG002|Participant Flow|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
10892667|NCT00529399|OG000|Outcome|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
10892668|NCT00529399|OG001|Outcome|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
10892669|NCT00529399|OG002|Outcome|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
10892670|NCT00529399|EG000|Reported Event|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
10892671|NCT00529399|EG001|Reported Event|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
10892672|NCT00529399|EG002|Reported Event|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
10892673|NCT00529451|BG000|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily
10892674|NCT00529451|BG001|Baseline|Aliskiren 150 mg|Aliskiren 150 mg once daily
10892675|NCT00529451|BG002|Baseline|Aliskiren 75 mg|Aliskiren 75 mg once daily
10892676|NCT00529451|BG003|Baseline|Ramipril 5 mg|Ramipril 5 mg once daily
10892677|NCT00529451|BG004|Baseline|Total|Total of all reporting groups
10892678|NCT00529451|FG000|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily
10892679|NCT00529451|FG001|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg once daily
10892680|NCT00529451|FG002|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg once daily
10892681|NCT00529451|FG003|Participant Flow|Ramipril 5 mg|Ramipril 5 mg once daily
10892682|NCT00529451|OG000|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
10892683|NCT00529451|OG001|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
10892684|NCT00529451|OG002|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
10892685|NCT00529451|OG003|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
10892686|NCT00529451|OG001|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
10892687|NCT00529451|OG000|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
10892688|NCT00529451|OG000|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
10892689|NCT00529451|EG000|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg once daily
10892690|NCT00529451|EG001|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg once daily
10892691|NCT00529451|EG002|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg once daily
11090257|NCT01528124|FG003|Participant Flow|1.5 mg LY3025876|1.5 mg LY3025876 administered as subcutaneous injection
10892692|NCT00529451|EG003|Reported Event|Ramipril 5 mg|Ramipril 5 mg once daily
10892693|NCT00529516|BG000|Baseline|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
10892694|NCT00529516|BG001|Baseline|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
10892695|NCT00529516|BG002|Baseline|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
10892696|NCT00529516|BG003|Baseline|Total|Total of all reporting groups
10892697|NCT00529516|FG000|Participant Flow|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
10892698|NCT00529516|FG001|Participant Flow|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
10892699|NCT00529516|FG002|Participant Flow|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
11090258|NCT01528124|FG004|Participant Flow|5 mg LY3025876|5 mg LY3025876 administered as subcutaneous injection
10892700|NCT00529516|OG000|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
10892701|NCT00529516|OG001|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
10892702|NCT00529516|OG002|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
10892703|NCT00529516|EG000|Reported Event|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
10892704|NCT00529516|EG001|Reported Event|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
10892705|NCT00529516|EG002|Reported Event|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
10892706|NCT00529529|BG000|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892707|NCT00529529|BG001|Baseline|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892708|NCT00529529|BG002|Baseline|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892709|NCT00529529|BG003|Baseline|Total|Total of all reporting groups
10892710|NCT00529529|FG000|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892711|NCT00529529|FG001|Participant Flow|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892712|NCT00529529|FG002|Participant Flow|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11090259|NCT01528124|FG005|Participant Flow|15 mg LY3025876|15 mg LY3025876 administered as subcutaneous injection
11090260|NCT01528124|FG006|Participant Flow|30 mg LY3025876|30 mg LY3025876 administered as subcutaneous injection
11090261|NCT01528124|OG000|Outcome|Placebo|Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
11090262|NCT01528124|OG001|Outcome|0.15 mg LY3025876|0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
11090263|NCT01528124|OG002|Outcome|0.5 mg LY3025876|0.5 mg LY3025876 administered as subcutaneous injection
11090264|NCT01528124|OG003|Outcome|1.5 mg LY3025876|1.5 mg LY3025876 administered as subcutaneous injection
11090265|NCT01528124|OG004|Outcome|5 mg LY3025876|5 mg LY3025876 administered as subcutaneous injection
11090266|NCT01528124|OG005|Outcome|15 mg LY3025876|15 mg LY3025876 administered as subcutaneous injection
11090267|NCT01528124|OG006|Outcome|30 mg LY3025876|30 mg LY3025876 administered as subcutaneous injection
11090268|NCT01528124|OG000|Outcome|0.15 mg LY3025876|0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
11090269|NCT01528124|OG001|Outcome|0.5 mg LY3025876|0.5 mg LY3025876 administered as subcutaneous injection
11090270|NCT01528124|OG002|Outcome|1.5 mg LY3025876|1.5 mg LY3025876 administered as subcutaneous injection
11090271|NCT01528124|OG003|Outcome|5 mg LY3025876|5 mg LY3025876 administered as subcutaneous injection
11090272|NCT01528124|OG004|Outcome|15 mg LY3025876|15 mg LY3025876 administered as subcutaneous injection
11090273|NCT01528124|OG005|Outcome|30 mg LY3025876|30 mg LY3025876 administered as subcutaneous injection
11090274|NCT01528124|EG000|Reported Event|Placebo|Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
11090275|NCT01528124|EG001|Reported Event|0.15 mg LY3025876|0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
10892713|NCT00529529|OG000|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892714|NCT00529529|OG001|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892715|NCT00529529|OG002|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892716|NCT00529529|EG000|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892717|NCT00529529|EG001|Reported Event|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892718|NCT00529529|EG002|Reported Event|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10892719|NCT00529542|BG000|Baseline|Atorvastatin|Atorvastatin, 40 mg qd
10892720|NCT00529542|BG001|Baseline|Placebo|Placebo qd
10892721|NCT00529542|BG002|Baseline|Total|Total of all reporting groups
10892722|NCT00529542|FG000|Participant Flow|Atorvastatin|Atorvastatin, 40 mg qd
10892723|NCT00529542|FG001|Participant Flow|Placebo|Placebo qd
11090276|NCT01528124|EG002|Reported Event|0.5 mg LY3025876|0.5 mg LY3025876 administered as subcutaneous injection
11090277|NCT01528124|EG003|Reported Event|1.5 mg LY3025876|1.5 mg LY3025876 administered as subcutaneous injection
10892724|NCT00529542|OG000|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
11090278|NCT01528124|EG004|Reported Event|5 mg LY3025876|5 mg LY3025876 administered as subcutaneous injection
11090279|NCT01528124|EG005|Reported Event|15 mg LY3025876|15 mg LY3025876 administered as subcutaneous injection
11090280|NCT01528124|EG006|Reported Event|30 mg LY3025876|30 mg LY3025876 administered as subcutaneous injection
11090281|NCT01528150|BG000|Baseline|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
10892725|NCT00529542|OG001|Outcome|Placebo|Placebo qd
10892726|NCT00529542|EG000|Reported Event|Atorvastatin|Atorvastatin, 40 mg qd
10892727|NCT00529542|EG001|Reported Event|Placebo|Placebo qd
10892728|NCT00529555|BG000|Baseline|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
10892729|NCT00529555|BG001|Baseline|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
10892730|NCT00529555|BG002|Baseline|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
10892731|NCT00529555|BG003|Baseline|Total|Total of all reporting groups
10892732|NCT00529555|FG000|Participant Flow|Scaling and Root Planing + SHAM TX|Empty syringe + Scaling and root planing
10892733|NCT00529555|FG001|Participant Flow|Scaling & Root Planing + Periocline Gel|"Gel WITH Minocycline HCL 2.1% + Scaling & root planing~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
10892734|NCT00529555|FG002|Participant Flow|Scaling and Root Planing + Vehicle|Gel WITHOUT 2.1% Minocycline HCl + Scaling and root planing
10892735|NCT00529555|OG000|Outcome|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
10892736|NCT00529555|OG001|Outcome|Scaling and Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
10892737|NCT00529555|OG002|Outcome|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
10892738|NCT00529555|EG000|Reported Event|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
10892739|NCT00529555|EG001|Reported Event|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
10892740|NCT00529555|EG002|Reported Event|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
10914751|NCT00632749|BG011|Baseline|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914752|NCT00632749|BG012|Baseline|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914753|NCT00632749|BG013|Baseline|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914754|NCT00632749|BG014|Baseline|Total|Total of all reporting groups
10914755|NCT00632749|FG000|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914756|NCT00632749|FG001|Participant Flow|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914757|NCT00632749|FG002|Participant Flow|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914758|NCT00632749|FG003|Participant Flow|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11090282|NCT01528150|FG000|Participant Flow|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
11090283|NCT01528150|OG000|Outcome|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
10914759|NCT00632749|FG004|Participant Flow|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914760|NCT00632749|FG005|Participant Flow|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914761|NCT00632749|FG006|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914762|NCT00632749|FG007|Participant Flow|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914763|NCT00632749|FG008|Participant Flow|80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914764|NCT00632749|FG009|Participant Flow|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11090284|NCT01528150|EG000|Reported Event|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
11090285|NCT01528215|BG000|Baseline|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
11090286|NCT01528215|BG001|Baseline|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
11090287|NCT01528215|BG002|Baseline|Total|Total of all reporting groups
11090288|NCT01528215|FG000|Participant Flow|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
11090289|NCT01528215|FG001|Participant Flow|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
11090290|NCT01528215|OG000|Outcome|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
11090291|NCT01528215|OG001|Outcome|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
11090292|NCT01528215|EG000|Reported Event|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
11090293|NCT01528215|EG001|Reported Event|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
10892741|NCT00529568|BG000|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10892742|NCT00529568|BG001|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10892743|NCT00529568|BG002|Baseline|Total|Total of all reporting groups
10892744|NCT00529568|FG000|Participant Flow|Eltrombopag: Open-label Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the Open-label Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
10892745|NCT00529568|FG001|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10892746|NCT00529568|FG002|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10892747|NCT00529568|OG000|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10892748|NCT00529568|OG001|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
11171253|NCT02002091|FG001|Participant Flow|Complications' Assessment for Women|205 patients had a complete clinical examination, we realized an electrocardiogram, some biological exams for glycemic, hepatical, hematological and inflammatory status. We performed, in assessing macroangiopathy, an echocardiography, a vascular ultrasonography, a cardiac stress testing (myocardial scintigraphy or stress electrocardiogram) to screen for ischemic myocardial, a coronaroangiography if indicated and a cerebral scanner in patients with suspected stroke. For the assessment of microangiopathy, we practiced a fundoscopy by an ophtalmologist, a neurological examination to screen for peripheral neuropathy, we performed the Ewing tests to screen for cardiac autonomic neuropathy, a post voiding residual to search for diabetic cystopathy, a manocystometry if indicated and evaluate the renal status (ACR, creatininemia, uro-nephrological echography) in all patients.
11171254|NCT02002091|OG000|Outcome|Men Group|Patients were assessed for diabetic retinopathy.
11171255|NCT02002091|OG001|Outcome|Women Group|Patients were assessed for diabetic retinopathy.
10892749|NCT00529568|OG000|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
10892750|NCT00529568|OG001|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10892751|NCT00529568|EG000|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of &lt;75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained &lt;100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
10892752|NCT00529568|EG001|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
10892753|NCT00529568|EG002|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
11171256|NCT02002091|OG000|Outcome|Men Group|All 122 patients were examined twice with the same method by the same physician.
11171257|NCT02002091|OG001|Outcome|Women Group|All 205 women were examined twice by the same physician that had examined men with the same method
11171258|NCT02002091|OG000|Outcome|Men Group Population|Screening for chronic kidney disease have been made for all patients.
11171259|NCT02002091|OG001|Outcome|Women Group Population|Screening for chronic kidney disease was performed in all patients.
11171260|NCT02002091|OG000|Outcome|Men Group Population|Hypertension was screened in patients at the time of diagnosis of type 2 diabetes. 19 patients already had hypertensive drugs.
11171261|NCT02002091|OG001|Outcome|Women Group Population|Hypertension was screened in all women in the same conditions than men. 49 patients had antihypertensive drugs.
10892754|NCT00529633|BG000|Baseline|Thalidomide|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Thalidomide for a period of 24 weeks.100 mg by mouth at night for 4 weeks; then if tolerated, Thalidomid will be increased to 200 mg by mouth at night for 20 weeks; for a total of 24 weeks on Thalidomid"
10892755|NCT00529633|BG001|Baseline|Placebo|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Placebo for a period of 24 weeks."
10892756|NCT00529633|BG002|Baseline|Total|Total of all reporting groups
10892757|NCT00529633|FG000|Participant Flow|Placebo|"This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.~Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin. Subject must meet capsule count of >85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program"
10892758|NCT00529633|FG001|Participant Flow|Thalidomide|"End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Thalidomide for a period of 24 weeks.~Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP~Thalidomide : 100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks"
10892759|NCT00529633|OG000|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
10892760|NCT00529633|OG001|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
10892761|NCT00529633|EG000|Reported Event|Thalidomide|"Patients will receive Thalidomide for a period of 24 weeks. Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP.~Thalidomide : 100 mg by mouth at night for 4 weeks; 200 mg by mouth at night for 20 weeks"
10892762|NCT00529633|EG001|Reported Event|Placebo|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.
11171262|NCT02002091|OG000|Outcome|Men Group Population|We screened for silent myocardial ischemia . We ensure of the absence of a chest pain in patients we screened.
11171263|NCT02002091|OG001|Outcome|Women Group Population|We screened for silent myocardial ischemia in 138 asymptomatic patients.
10892763|NCT00529659|BG000|Baseline|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
10892764|NCT00529659|BG001|Baseline|Placebo|Placebo administered orally twice daily.
10892765|NCT00529659|BG002|Baseline|Total|Total of all reporting groups
10892766|NCT00529659|FG000|Participant Flow|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
10892767|NCT00529659|FG001|Participant Flow|Placebo|Placebo administered orally twice daily.
10892768|NCT00529659|OG000|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
10892769|NCT00529659|OG001|Outcome|Placebo|Placebo administered orally twice daily.
10892770|NCT00529659|EG000|Reported Event|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
10892771|NCT00529659|EG001|Reported Event|Placebo|Placebo administered orally twice daily.
10892772|NCT00529789|BG000|Baseline|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
10892773|NCT00529789|FG000|Participant Flow|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
10892774|NCT00529789|OG000|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
11171264|NCT02002091|OG000|Outcome|Men Group Population|In the men's group screened for lower limb arterial disease, there were significantly more tobacco use (52 patients) than in the women's group (see characteristics)
11171265|NCT02002091|OG001|Outcome|Women Group Population|In the women's group 33 patients had a tobacco use
11171266|NCT02002091|OG000|Outcome|Men Group Population|The men's group had some characterictics that differ from women's group. Tobacco is more widely used in men
11171267|NCT02002091|OG001|Outcome|Women Group Population|The women in this group have a mean body mass index higher than in the men's group
11171268|NCT02002091|OG000|Outcome|Men Group Population|Those patients who perform renal artery ultrasonography had severe hypertension treated with at least four anti hypertensive drugs including one diuretic or a blood pressure over 180/100 mm Hg
11171269|NCT02002091|OG001|Outcome|Women Group Population|Patients that had an ultrasonography of renal arteries, had severe hypertension treated with at least four anti hypertensive drug including one diuretic or a blood pressure over 180/100 mm Hg
11171270|NCT02002091|OG000|Outcome|Men Group Population|We screened the men's group for cardiac autonomic neuropathy.
11171271|NCT02002091|OG001|Outcome|Women Group Population|.We screened women's group for cardiac autonomic neuropathy.
10892775|NCT00529789|OG000|Outcome|Duloxetine Dose - 20 mg|20 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up.
10892776|NCT00529789|OG001|Outcome|Duloxetine Dose - 30 mg|30 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
10892777|NCT00529789|OG002|Outcome|Duloxetine - 60 mg|60 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
10892778|NCT00529789|OG003|Outcome|Duloxetine Dose - 90 mg|90 milligrams (mg) every day (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
10892779|NCT00529789|OG004|Outcome|Duloxetine - 120 mg|120 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
10892780|NCT00529789|EG000|Reported Event|Duloxetine - Period II/III|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 18 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
10892781|NCT00529789|EG001|Reported Event|Duloxetine - Period IV|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) between Weeks 18 - 30; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
10892782|NCT00529802|BG000|Baseline|Everolimus|All patients were to receive 10mg everolimus (RAD001) daily.
10892783|NCT00529802|FG000|Participant Flow|Everolimus|All patients were to receive 10mg everolimus (RAD001) daily.
10892784|NCT00529802|OG000|Outcome|Low Uptake|"Low uptake FDG-PET is defined as avgSUVmax<=4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the standardized uptake value) ."
10892785|NCT00529802|OG001|Outcome|High Uptake|"High uptake of FDG-PET defined as avgSUVmax>4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the standardized uptake value) ."
11090294|NCT01528228|BG000|Baseline|Structured TENS Therapy|"This group will be given an active TENS unit to use.~TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units."
10892786|NCT00529802|OG000|Outcome|Patients Evaluable for Secondary Outcome|Patients who had two FDG-PET scans completed, one at baseline and one after 2 weeks of treatment, were evaluable for secondary outcome.
10892787|NCT00529802|EG000|Reported Event|Everolimus|"All patients were to receive 10mg everolimus (RAD001) daily.~These results are based on n=56 patients who were evaluable for toxicity."
10892788|NCT00529958|BG000|Baseline|Patellar Tendon (PT)|"ACL reconstruction using a patellar tendon autograft~Patellar Tendon: Patellar Tendon autograft"
10892789|NCT00529958|BG001|Baseline|Hamstring (HT)|"ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft~Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft"
10892790|NCT00529958|BG002|Baseline|Double-Bundle (DB)|"ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft~Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft"
10892791|NCT00529958|BG003|Baseline|Total|Total of all reporting groups
10892792|NCT00529958|FG000|Participant Flow|Patellar Tendon (PT)|"ACL reconstruction using a patellar tendon autograft~Patellar Tendon: Patellar Tendon autograft"
10892793|NCT00529958|FG001|Participant Flow|Hamstring (HT)|"ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft~Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft"
10892794|NCT00529958|FG002|Participant Flow|Double-Bundle (DB)|"ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft~Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft"
10892795|NCT00529958|OG000|Outcome|Patellar Tendon (PT)|"ACL reconstruction using a patellar tendon autograft~Patellar Tendon: Patellar Tendon autograft"
10892796|NCT00529958|OG001|Outcome|Hamstring (HT)|"ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft~Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft"
10892797|NCT00529958|OG002|Outcome|Double-Bundle (DB)|"ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft~Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft"
10892798|NCT00529958|EG000|Reported Event|Patellar Tendon (PT)|"ACL reconstruction using a patellar tendon autograft~Patellar Tendon: Patellar Tendon autograft"
10892799|NCT00529958|EG001|Reported Event|Hamstring (HT)|"ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft~Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft"
10892800|NCT00529958|EG002|Reported Event|Double-Bundle (DB)|"ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft~Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft"
10892801|NCT00530023|BG000|Baseline|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
10892802|NCT00530023|BG001|Baseline|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
10892803|NCT00530023|BG002|Baseline|Total|Total of all reporting groups
10892804|NCT00530023|FG000|Participant Flow|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
10892805|NCT00530023|FG001|Participant Flow|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
10892806|NCT00530023|OG000|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
10892807|NCT00530023|OG001|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
10892808|NCT00530023|EG000|Reported Event|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
10892809|NCT00530023|EG001|Reported Event|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
10892810|NCT00530075|BG000|Baseline|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
10892811|NCT00530075|FG000|Participant Flow|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
10892812|NCT00530075|OG000|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
10892813|NCT00530075|EG000|Reported Event|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
10892814|NCT00530088|BG000|Baseline|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
10892815|NCT00530088|FG000|Participant Flow|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
10892816|NCT00530088|OG000|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
10892817|NCT00530088|EG000|Reported Event|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
10892818|NCT00530218|BG000|Baseline|All Study Participants|Blood Culture at Day 21 or later -or- PCR Test at Day 21 or later
10892819|NCT00530218|FG000|Participant Flow|All Study Participants|Patients undergo intervention with intravenous ganciclovir followed by oral ganciclovir, if cytomegalovirus reactivation is detected.
10892820|NCT00530218|OG000|Outcome|CMV Reactivation Patients With GCV|CMV reactivation patients with intravenous Ganciclovir followed by oral Ganciclovir.
10892821|NCT00530218|OG000|Outcome|All Study Participants|Blood Culture at Day 21 or later -or- PCR Test at Day 21 or later
10892822|NCT00530218|OG000|Outcome|Compliance Among Patients With CMV Reactivation|Patients with CMV reactivation detected by blood culture or PCR test.
10892823|NCT00530218|EG000|Reported Event|Patients With CMV Reactivation Detected|CMV Positive Blood Culture at Day 21 or later -or- CMV Positive PCR Test at Day 21 or later
10892824|NCT00530218|EG001|Reported Event|Patients Without CMV Reactivation Detected|No CMV Positive Blood Culture at Day 21 or later -and- No CMV Positive PCR Test at Day 21 or later
10892825|NCT00530257|BG000|Baseline|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed on the measures described below.
10892826|NCT00530257|FG000|Participant Flow|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed on the measures described below.
10892827|NCT00530257|OG000|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
10892828|NCT00530257|OG001|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
10892829|NCT00530257|OG001|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
10892830|NCT00530257|EG000|Reported Event|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
10892831|NCT00530257|EG001|Reported Event|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
10892832|NCT00530270|BG000|Baseline|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
10892833|NCT00530270|BG001|Baseline|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
10892834|NCT00530270|BG002|Baseline|Total|Total of all reporting groups
10892835|NCT00530270|FG000|Participant Flow|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
10892836|NCT00530270|FG001|Participant Flow|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
11171272|NCT02002091|OG000|Outcome|Men Group Population|In the men's group, the diagnosis of autonomic neuropathy of bladder was made as specified.
10892837|NCT00530270|OG000|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
10892838|NCT00530270|OG001|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
10892839|NCT00530270|EG000|Reported Event|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
10892840|NCT00530270|EG001|Reported Event|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
10892841|NCT00530335|BG000|Baseline|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
10892842|NCT00530335|FG000|Participant Flow|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
10892843|NCT00530335|OG000|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
10892844|NCT00530335|EG000|Reported Event|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
10892845|NCT00530348|BG000|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
10892846|NCT00530348|BG001|Baseline|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
10892847|NCT00530348|BG002|Baseline|Total|Total of all reporting groups
10892848|NCT00530348|FG000|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
11171273|NCT02002091|OG001|Outcome|Women Group Population|women were slightly older than men. the diagnosis was done the same way than in men.
11171274|NCT02002091|OG000|Outcome|Men's Group Population|All men participated to interview.
11171275|NCT02002091|OG001|Outcome|Women Group Population|All women participated to interview.
10892849|NCT00530348|FG001|Participant Flow|Alemtuzumab|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
10892850|NCT00530348|OG000|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
10892851|NCT00530348|OG001|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
10892852|NCT00530348|EG000|Reported Event|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
10892853|NCT00530348|EG001|Reported Event|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
10892854|NCT00530439|BG000|Baseline|Lifestyle Intervention|physical activity, dietetic counselling
10892855|NCT00530439|BG001|Baseline|Control|
10892856|NCT00530439|BG002|Baseline|Total|Total of all reporting groups
10892857|NCT00530439|FG000|Participant Flow|Lifestyle Intervention|physical activity, dietetic counselling
10892858|NCT00530439|FG001|Participant Flow|Control|
11171276|NCT02002091|OG000|Outcome|Men Group Population|122 men were assessed for erectile dysfunction .
11171277|NCT02002091|OG000|Outcome|Men Group Population|We re-evaluated all patients for cardiac events during one year after recruitment.
11171278|NCT02002091|OG001|Outcome|Women Group Population|All women were re-evaluated during one year of follow-up.
10892859|NCT00530439|OG000|Outcome|Lifestyle Intervention|physical activity, dietetic counselling
10892860|NCT00530439|OG001|Outcome|Control|
10892861|NCT00530439|EG000|Reported Event|Lifestyle Intervention|physical activity, dietetic counselling
10892862|NCT00530439|EG001|Reported Event|Control|
10892863|NCT00530504|BG000|Baseline|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
10892864|NCT00530504|FG000|Participant Flow|Stent and Protection Device|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
10892865|NCT00530504|OG000|Outcome|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
11171279|NCT02002091|OG000|Outcome|Men Group Population|All men were evaluated for stroke one year after recruitment.
11171280|NCT02002091|OG001|Outcome|Women Group Population|All women were evaluated for stroke after one year of follow-up.
11171281|NCT02002091|OG000|Outcome|Men Group Population|109 men were evaluated for new lower limb atherothrombotic events, after one year after recruitment.
11171282|NCT02002091|OG001|Outcome|Women Group Population|191 women were evaluated for lower limb atherothrombotic events, after one year of follow-up.
11171283|NCT02002091|OG000|Outcome|Men Group Population|112 men were evaluated and followed-up after recruitment.
11171284|NCT02002091|OG001|Outcome|Women Group Population|193 women were evaluated and followed-up from recruitment.
11171285|NCT02002091|EG000|Reported Event|Men's Group|From 122 men at recruitment, 112 had been followed-up one year or until death. 109 had complete one year of follow-up.
11171286|NCT02002091|EG001|Reported Event|Women's Group|From 205 women, 193 had been followed-up one year or until death. 191 women had complete one year of follow-up.
10892866|NCT00530504|EG000|Reported Event|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
10892867|NCT00530621|BG000|Baseline|Pemetrexed + Enzastaurin|"Enzastaurin 1125 milligrams (mg) loading dose [total 9 tablets (three 125-mg tablets administered orally 3 times a day)] on Day 1 followed by total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) on Days 2 to 28, and pemetrexed 500 milligrams per square meter (mg/m^2) intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892868|NCT00530621|BG001|Baseline|Pemetrexed + Placebo|"Placebo loading dose [total 9 tablets (3 tablets administered orally 3 times a day)] on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 2 to 28, and pemetrexed 500 mg/m^2 intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892869|NCT00530621|BG002|Baseline|Total|Total of all reporting groups
10892870|NCT00530621|FG000|Participant Flow|Pemetrexed + Enzastaurin|"Enzastaurin 1125 milligrams (mg) loading dose [total 9 tablets (three 125-mg tablets administered orally 3 times a day)] on Day 1 followed by total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) on Days 2 to 28, and pemetrexed 500 milligrams per square meter (mg/m^2) intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892871|NCT00530621|FG001|Participant Flow|Pemetrexed + Placebo|"Placebo loading dose [total 9 tablets (3 tablets administered orally 3 times a day)] on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 2 to 28, and pemetrexed 500 mg/m^2 intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892872|NCT00530621|OG000|Outcome|Pemetrexed + Enzastaurin|"Enzastaurin 1125 milligrams (mg) loading dose [total 9 tablets (three 125-mg tablets administered orally 3 times a day)] on Day 1 followed by total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) on Days 2 to 28, and pemetrexed 500 milligrams per square meter (mg/m^2) intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892873|NCT00530621|OG001|Outcome|Pemetrexed + Placebo|"Placebo loading dose [total 9 tablets (3 tablets administered orally 3 times a day)] on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 2 to 28, and pemetrexed 500 mg/m^2 intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892874|NCT00530621|OG000|Outcome|Pemetrexed + Enzastaurin|"Enzastaurin 1125 milligrams (mg) loading dose [total 9 tablets; three (125-mg) tablets administered orally 3 times a day] on Day 1 followed by total dose of 500 mg enzastaurin [two (125-mg) tablets administered orally 2 times a day] on Days 2 to 28, and pemetrexed 500 milligrams per square meter (mg/m^2) intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by total dose of 500 mg enzastaurin [two (125-mg) tablets administered orally 2 times a day] on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892875|NCT00530621|OG001|Outcome|Pemetrexed + Placebo|"Placebo loading dose (total 9 tablets; three tablets administered orally 3 times a day) on Day 1 followed by four placebo tablets (two tablets 2 times a day) on Days 2 to 28, and pemetrexed 500 mg/m^2 intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by four placebo tablets (two tablets 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met.~."
10892876|NCT00530621|OG002|Outcome|Total (Pemetrexed + Enzastaurin and Pemetrexed + Placebo)|"Enzastaurin (1125 mg loading dose of 9 tablets) or placebo (loading dose of 9 tablets) administered on Day 1 followed total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) or four placebo tablets (2 tablets 2 times a day) on Days 2 to 28, and pemetrexed 500 mg/m^2 intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by total dose of 500 mg enzastaurin [two 125-mg tablets administered orally 2 times a day] or four placebo tablets (2 tablets 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10914765|NCT00632749|FG010|Participant Flow|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11090295|NCT01528228|BG001|Baseline|Sham TENS Therapy|"This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.~TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units."
10892877|NCT00530621|OG001|Outcome|Pemetrexed + Placebo|"Placebo loading dose [total 9 tablets (3 tablets administered orally 3 times a day)] on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 2 to 28, and pemetrexed 500 mg/m^2 intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met.~."
10892878|NCT00530621|EG000|Reported Event|Pemetrexed + Enzastaurin|"Enzastaurin 1125 milligrams (mg) loading dose [total 9 tablets (three 125-mg tablets administered orally 3 times a day)] on Day 1 followed by total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) on Days 2 to 28, and pemetrexed 500 milligrams per square meter (mg/m^2) intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by total dose of 500 mg enzastaurin (two 125-mg tablets administered orally 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892879|NCT00530621|EG001|Reported Event|Pemetrexed + Placebo|"Placebo loading dose [total 9 tablets (3 tablets administered orally 3 times a day)] on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 2 to 28, and pemetrexed 500 mg/m^2 intravenous injection on Day 8 in Cycle 1 (28-day cycle).~Pemetrexed 500 mg/m^2 intravenous injection on Day 1 followed by 4 placebo tablets (2 tablets 2 times a day) on Days 1 to 21 in Cycle 2 and subsequent cycles (21-day cycle).~Treatment was continued until evidence of disease progression, unacceptable toxicity, or any other discontinuation criteria were met."
10892880|NCT00530634|BG000|Baseline|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
10892881|NCT00530634|FG000|Participant Flow|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
10892882|NCT00530634|OG000|Outcome|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
10892883|NCT00530634|EG000|Reported Event|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
10892884|NCT00530712|BG000|Baseline|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
10892885|NCT00530712|FG000|Participant Flow|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
10892886|NCT00530712|OG000|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
10892887|NCT00530712|OG000|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
10892888|NCT00530712|EG000|Reported Event|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
10892889|NCT00530764|BG000|Baseline|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
10892890|NCT00530764|BG001|Baseline|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
10892891|NCT00530764|BG002|Baseline|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
10892892|NCT00530764|BG003|Baseline|Placebo|Range of 1-16 sprays per day of placebo spray
10892893|NCT00530764|BG004|Baseline|Total|Total of all reporting groups
10892894|NCT00530764|FG000|Participant Flow|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
10892895|NCT00530764|FG001|Participant Flow|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
10892896|NCT00530764|FG002|Participant Flow|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
10892897|NCT00530764|FG003|Participant Flow|Placebo|Range of 1-16 sprays per day of placebo spray
10892898|NCT00530764|OG000|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
11090296|NCT01528228|BG002|Baseline|Total|Total of all reporting groups
10892899|NCT00530764|OG001|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
10892900|NCT00530764|OG002|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
10892901|NCT00530764|OG003|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
10892902|NCT00530764|OG000|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
10892903|NCT00530764|OG001|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
10892904|NCT00530764|OG002|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
10892905|NCT00530764|EG000|Reported Event|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
10892906|NCT00530764|EG001|Reported Event|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
10892907|NCT00530764|EG002|Reported Event|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
10892908|NCT00530764|EG003|Reported Event|Placebo|Range of 1-16 sprays per day of placebo spray
10892909|NCT00530777|BG000|Baseline|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
10892910|NCT00530777|BG001|Baseline|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
10892911|NCT00530777|BG002|Baseline|Total|Total of all reporting groups
10892912|NCT00530777|FG000|Participant Flow|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
10892913|NCT00530777|FG001|Participant Flow|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
10892914|NCT00530777|OG000|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
10892915|NCT00530777|OG001|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
10892916|NCT00530777|EG000|Reported Event|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
10892917|NCT00530777|EG001|Reported Event|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
10892918|NCT00530790|BG000|Baseline|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
10892919|NCT00530790|FG000|Participant Flow|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
10892920|NCT00530790|OG000|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
10892921|NCT00530790|EG000|Reported Event|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
10892922|NCT00530803|BG000|Baseline|EMLA Cream|"Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.~EMLA Cream: 60 minutes x1"
10892923|NCT00530803|BG001|Baseline|Synera Patch|"Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.~Synera Patch: 20 minutes x1"
10892924|NCT00530803|BG002|Baseline|Total|Total of all reporting groups
10892925|NCT00530803|FG000|Participant Flow|EMLA Cream|"Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.~EMLA Cream: 60 minutes x1"
10892926|NCT00530803|FG001|Participant Flow|Synera Patch|"Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.~Synera Patch: 20 minutes x1"
10892927|NCT00530803|OG000|Outcome|EMLA Cream|"Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.~EMLA Cream: 60 minutes x1"
10892928|NCT00530803|OG001|Outcome|Synera Patch|"Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.~Synera Patch: 20 minutes x1"
10892929|NCT00530803|EG000|Reported Event|EMLA Cream|"Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.~EMLA Cream: 60 minutes x1"
10892930|NCT00530803|EG001|Reported Event|Synera Patch|"Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.~Synera Patch: 20 minutes x1"
10892931|NCT00530816|BG000|Baseline|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
10892932|NCT00530816|BG001|Baseline|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
10892933|NCT00530816|BG002|Baseline|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
10892934|NCT00530816|BG003|Baseline|Total|Total of all reporting groups
10892935|NCT00530816|FG000|Participant Flow|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
10892936|NCT00530816|FG001|Participant Flow|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
10892937|NCT00530816|FG002|Participant Flow|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
10892938|NCT00530816|OG000|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
10892939|NCT00530816|OG001|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
10892940|NCT00530816|OG002|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
10892941|NCT00530816|EG000|Reported Event|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
10892942|NCT00530816|EG001|Reported Event|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
10892943|NCT00530816|EG002|Reported Event|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
10892944|NCT00530842|BG000|Baseline|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
10892945|NCT00530842|BG001|Baseline|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
10892946|NCT00530842|BG002|Baseline|Total|Total of all reporting groups
10892947|NCT00530842|FG000|Participant Flow|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
10892948|NCT00530842|FG001|Participant Flow|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
10892949|NCT00530842|OG000|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
10892950|NCT00530842|OG001|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
10892951|NCT00530842|EG000|Reported Event|Tiotropium + Salmeterol (Period 1)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1
11090297|NCT01528228|FG000|Participant Flow|Structured TENS Therapy|"This group will be given an active TENS unit to use.~TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units."
10892952|NCT00530842|EG001|Reported Event|Tiotropium + Salmeterol (Period 2)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 2
10892953|NCT00530842|EG002|Reported Event|Fluticasone + Salmeterol (Period 1)|Flu+Sal 500+50mcg b.i.d. in Period 1
10892954|NCT00530842|EG003|Reported Event|Fluticasone + Salmeterol (Period 2)|Flu+Sal 500+50mcg b.i.d. in Period 2
10892955|NCT00530855|BG000|Baseline|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
10892956|NCT00530855|FG000|Participant Flow|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
10892957|NCT00530855|OG000|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
10892958|NCT00530855|EG000|Reported Event|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
10892959|NCT00530894|BG000|Baseline|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892960|NCT00530894|BG001|Baseline|High Risk: SAVR|Surgical Valve Replacement
10892961|NCT00530894|BG002|Baseline|Inoperable TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892962|NCT00530894|BG003|Baseline|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
10892963|NCT00530894|BG004|Baseline|Total|Total of all reporting groups
10892964|NCT00530894|FG000|Participant Flow|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892965|NCT00530894|FG001|Participant Flow|High Risk: SAVR|Surgical Aortic Valve Replacement
10892966|NCT00530894|FG002|Participant Flow|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892967|NCT00530894|FG003|Participant Flow|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
10892968|NCT00530894|OG000|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892969|NCT00530894|OG001|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
10892970|NCT00530894|OG002|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892971|NCT00530894|OG003|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
10892972|NCT00530894|OG000|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892973|NCT00530894|OG001|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
10892974|NCT00530894|EG000|Reported Event|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892975|NCT00530894|EG001|Reported Event|High Risk: SAVR|Surgical Aortic Valve Replacement
10892976|NCT00530894|EG002|Reported Event|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
10892977|NCT00530894|EG003|Reported Event|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
10892978|NCT00530920|BG000|Baseline|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
10892979|NCT00530920|BG001|Baseline|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
10892980|NCT00530920|BG002|Baseline|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
10892981|NCT00530920|BG003|Baseline|Total|Total of all reporting groups
10892982|NCT00530920|FG000|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
10892983|NCT00530920|FG001|Participant Flow|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given once daily
10892984|NCT00530920|FG002|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
10892985|NCT00530920|OG000|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
10892986|NCT00530920|OG001|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
10892987|NCT00530920|OG002|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
10892988|NCT00530920|OG001|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
10892989|NCT00530920|EG000|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
10892990|NCT00530920|EG001|Reported Event|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
10892991|NCT00530920|EG002|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
10892992|NCT00530946|BG000|Baseline|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
10892993|NCT00530946|BG001|Baseline|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
10892994|NCT00530946|BG002|Baseline|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
10892995|NCT00530946|BG003|Baseline|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
10892996|NCT00530946|BG004|Baseline|Total|Total of all reporting groups
10892997|NCT00530946|FG000|Participant Flow|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
10892998|NCT00530946|FG001|Participant Flow|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
10892999|NCT00530946|FG002|Participant Flow|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
10893000|NCT00530946|FG003|Participant Flow|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
10893001|NCT00530946|OG000|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
10893002|NCT00530946|OG001|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
10893003|NCT00530946|OG002|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
10893004|NCT00530946|OG003|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
10893005|NCT00530946|EG000|Reported Event|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
10893006|NCT00530946|EG001|Reported Event|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
10893007|NCT00530946|EG002|Reported Event|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
10893008|NCT00530946|EG003|Reported Event|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
10893009|NCT00531011|BG000|Baseline|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
10893010|NCT00531011|BG001|Baseline|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
10893011|NCT00531011|BG002|Baseline|Total|Total of all reporting groups
10893012|NCT00531011|FG000|Participant Flow|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
10893013|NCT00531011|FG001|Participant Flow|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
10893014|NCT00531011|OG000|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
10893015|NCT00531011|OG001|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
10893016|NCT00531011|EG000|Reported Event|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
10893017|NCT00531011|EG001|Reported Event|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
10893018|NCT00531050|BG000|Baseline|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893019|NCT00531050|BG001|Baseline|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893020|NCT00531050|BG002|Baseline|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893021|NCT00531050|BG003|Baseline|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893022|NCT00531050|BG004|Baseline|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893023|NCT00531050|BG005|Baseline|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893024|NCT00531050|BG006|Baseline|Total|Total of all reporting groups
10893025|NCT00531050|FG000|Participant Flow|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893026|NCT00531050|FG001|Participant Flow|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
11335623|NCT03554005|OG002|Outcome|PEG Interferon Alfa-2b 3 mcg/kg OW|Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10893027|NCT00531050|FG002|Participant Flow|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893028|NCT00531050|FG003|Participant Flow|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893029|NCT00531050|FG004|Participant Flow|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893030|NCT00531050|FG005|Participant Flow|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
10893031|NCT00531050|OG000|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
10893032|NCT00531050|OG001|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
10893033|NCT00531050|OG002|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
10893034|NCT00531050|OG000|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10893035|NCT00531050|OG001|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10893036|NCT00531050|OG002|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10893037|NCT00531050|OG003|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10914766|NCT00632749|FG011|Participant Flow|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10893038|NCT00531050|OG004|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10893039|NCT00531050|OG005|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10893040|NCT00531050|EG000|Reported Event|Part 1:Indacaterol 300mcg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
10893041|NCT00531050|EG001|Reported Event|Part 1:Salmeterol 50mcg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
10893042|NCT00531050|EG002|Reported Event|Part 1:Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
10893043|NCT00531050|EG003|Reported Event|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10893044|NCT00531050|EG004|Reported Event|Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10893045|NCT00531050|EG005|Reported Event|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
10893046|NCT00531206|BG000|Baseline|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
10893047|NCT00531206|FG000|Participant Flow|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
10893048|NCT00531206|OG000|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
10893049|NCT00531206|EG000|Reported Event|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
10893050|NCT00531284|BG000|Baseline|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893051|NCT00531284|BG001|Baseline|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893052|NCT00531284|BG002|Baseline|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893053|NCT00531284|BG003|Baseline|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893054|NCT00531284|BG004|Baseline|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893055|NCT00531284|BG005|Baseline|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893056|NCT00531284|BG006|Baseline|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893057|NCT00531284|BG007|Baseline|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893058|NCT00531284|BG008|Baseline|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893059|NCT00531284|BG009|Baseline|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893060|NCT00531284|BG010|Baseline|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893061|NCT00531284|BG011|Baseline|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893062|NCT00531284|BG012|Baseline|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893063|NCT00531284|BG013|Baseline|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893064|NCT00531284|BG014|Baseline|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893065|NCT00531284|BG015|Baseline|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893066|NCT00531284|BG016|Baseline|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893067|NCT00531284|BG017|Baseline|Total|Total of all reporting groups
10893068|NCT00531284|FG000|Participant Flow|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893069|NCT00531284|FG001|Participant Flow|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893070|NCT00531284|FG002|Participant Flow|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893071|NCT00531284|FG003|Participant Flow|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893072|NCT00531284|FG004|Participant Flow|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893073|NCT00531284|FG005|Participant Flow|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893074|NCT00531284|FG006|Participant Flow|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893075|NCT00531284|FG007|Participant Flow|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893076|NCT00531284|FG008|Participant Flow|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893077|NCT00531284|FG009|Participant Flow|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893078|NCT00531284|FG010|Participant Flow|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893079|NCT00531284|FG011|Participant Flow|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893080|NCT00531284|FG012|Participant Flow|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893081|NCT00531284|FG013|Participant Flow|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893082|NCT00531284|FG014|Participant Flow|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893083|NCT00531284|FG015|Participant Flow|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893084|NCT00531284|FG016|Participant Flow|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893085|NCT00531284|OG000|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893086|NCT00531284|OG001|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893087|NCT00531284|OG002|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893088|NCT00531284|OG003|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893089|NCT00531284|OG004|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893090|NCT00531284|OG005|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893091|NCT00531284|OG006|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893092|NCT00531284|OG007|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893093|NCT00531284|OG008|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893094|NCT00531284|OG009|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893095|NCT00531284|OG010|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
11171287|NCT02002182|BG000|Baseline|Treatment-Vaccine Group|"Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.~ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy."
10893096|NCT00531284|OG011|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893097|NCT00531284|OG012|Outcome|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893098|NCT00531284|OG013|Outcome|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893099|NCT00531284|OG000|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment.
10893100|NCT00531284|OG003|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
11171288|NCT02002182|BG001|Baseline|Control Group|Observational control group treated with standard of care therapy only
11171289|NCT02002182|BG002|Baseline|Total|Total of all reporting groups
10893101|NCT00531284|OG004|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893102|NCT00531284|OG005|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893103|NCT00531284|OG006|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893104|NCT00531284|OG007|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893105|NCT00531284|OG008|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893106|NCT00531284|OG009|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
11171290|NCT02002182|FG000|Participant Flow|Treatment-Vaccine Group|"Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.~ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy."
11171291|NCT02002182|FG001|Participant Flow|Control Group|Observational control group treated with standard of care therapy only
10893107|NCT00531284|OG010|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893108|NCT00531284|OG011|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893109|NCT00531284|OG012|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893110|NCT00531284|OG013|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893111|NCT00531284|OG014|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893112|NCT00531284|OG015|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893113|NCT00531284|OG016|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893114|NCT00531284|OG017|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893115|NCT00531284|OG018|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893116|NCT00531284|OG016|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893117|NCT00531284|OG000|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
10893118|NCT00531284|OG001|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
10893119|NCT00531284|OG002|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
10893120|NCT00531284|OG003|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
11090298|NCT01528228|FG001|Participant Flow|Sham TENS Therapy|"This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.~TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units."
11090299|NCT01528228|OG000|Outcome|Structured TENS Therapy|"This group will be given an active TENS unit to use.~TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units."
11090300|NCT01528228|OG001|Outcome|Sham TENS Therapy|"This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.~TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units."
11090301|NCT01528228|EG000|Reported Event|Structured TENS Therapy|"This group will be given an active TENS unit to use.~TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units."
11090302|NCT01528228|EG001|Reported Event|Sham TENS Therapy|"This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.~TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units."
11090303|NCT01528254|BG000|Baseline|Vilda 50mg Bid + Metformin|vildagliptin (Vilda 50mg bid) + Metformin
10893121|NCT00531284|OG004|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
10893122|NCT00531284|EG000|Reported Event|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893123|NCT00531284|EG001|Reported Event|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893124|NCT00531284|EG002|Reported Event|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893125|NCT00531284|EG003|Reported Event|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893126|NCT00531284|EG004|Reported Event|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893127|NCT00531284|EG005|Reported Event|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893128|NCT00531284|EG006|Reported Event|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893129|NCT00531284|EG007|Reported Event|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893130|NCT00531284|EG008|Reported Event|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893131|NCT00531284|EG009|Reported Event|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893132|NCT00531284|EG010|Reported Event|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893133|NCT00531284|EG011|Reported Event|P1B MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893134|NCT00531284|EG012|Reported Event|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893135|NCT00531284|EG013|Reported Event|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893136|NCT00531284|EG014|Reported Event|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893137|NCT00531284|EG015|Reported Event|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
11090304|NCT01528254|BG001|Baseline|Placebo + Metformin|Placebo of vildagliptin (Vilda 50mg bid) + Metformin
11090305|NCT01528254|BG002|Baseline|Total|Total of all reporting groups
11090306|NCT01528254|FG000|Participant Flow|Vilda 50mg Bid + Metformin|vildagliptin (Vilda 50mg bid) + Metformin
10893138|NCT00531284|EG016|Reported Event|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
10893139|NCT00531427|BG000|Baseline|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
10893140|NCT00531427|BG001|Baseline|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
10893141|NCT00531427|BG002|Baseline|Total|Total of all reporting groups
10893142|NCT00531427|FG000|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
10893143|NCT00531427|FG001|Participant Flow|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
10893144|NCT00531427|OG000|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
10893145|NCT00531427|OG001|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
10893146|NCT00531427|EG000|Reported Event|Double-blind BTDS|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
10893147|NCT00531427|EG001|Reported Event|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
10893148|NCT00531427|EG002|Reported Event|Open-label Run-in Period|The open-label run-in period was designed with duration of time sufficient to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). During this period, subjects were required to discontinue use of all nonstudy drugs used for the treatment of chronic pain and no supplemental analgesic medications were allowed. Subjects who did not tolerate BTDS 5 were discontinued from the study.
10893149|NCT00531453|BG000|Baseline|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
10893150|NCT00531453|BG001|Baseline|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
10893151|NCT00531453|BG002|Baseline|Total|Total of all reporting groups
10893152|NCT00531453|FG000|Participant Flow|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
10893153|NCT00531453|FG001|Participant Flow|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
10893154|NCT00531453|OG000|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
10893155|NCT00531453|OG001|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
10893156|NCT00531453|EG000|Reported Event|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
10893157|NCT00531453|EG001|Reported Event|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
10893158|NCT00531479|BG000|Baseline|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
10893159|NCT00531479|BG001|Baseline|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
10893160|NCT00531479|BG002|Baseline|Total|Total of all reporting groups
10893161|NCT00531479|FG000|Participant Flow|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
10893162|NCT00531479|FG001|Participant Flow|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
10893163|NCT00531479|OG000|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
10893164|NCT00531479|OG001|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
10893165|NCT00531479|EG000|Reported Event|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
11090307|NCT01528254|FG001|Participant Flow|Placebo + Metformin|Placebo of vildagliptin (Vilda 50mg bid) + Metformin
11090308|NCT01528254|OG000|Outcome|Vilda 50mg Bid + Metformin|vildagliptin (Vilda 50mg bid) + Metformin
10893166|NCT00531479|EG001|Reported Event|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
10893167|NCT00531518|BG000|Baseline|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
10893168|NCT00531518|BG001|Baseline|Experimental Intervention|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
10893169|NCT00531518|BG002|Baseline|Total|Total of all reporting groups
10893170|NCT00531518|FG000|Participant Flow|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
10893171|NCT00531518|FG001|Participant Flow|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
10893172|NCT00531518|OG000|Outcome|Control|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
10893173|NCT00531518|OG001|Outcome|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
11090309|NCT01528254|OG001|Outcome|Placebo + Metformin|Placebo of vildagliptin (Vilda 50mg bid) + Metformin
11090310|NCT01528254|EG000|Reported Event|Vilda 50mg Bid + Metformin|vildagliptin (Vilda 50mg bid) + Metformin
11090311|NCT01528254|EG001|Reported Event|Placebo + Metformin|Placebo of vildagliptin (Vilda 50mg bid) + Metformin
11090312|NCT01528254|EG002|Reported Event|Total|Total
11090313|NCT01528319|BG000|Baseline|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
11090314|NCT01528319|FG000|Participant Flow|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
11090315|NCT01528319|OG000|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
10893174|NCT00531518|EG000|Reported Event|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
10893175|NCT00531518|EG001|Reported Event|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
11090316|NCT01528319|EG000|Reported Event|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
11090317|NCT01528332|BG000|Baseline|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
11090318|NCT01528332|BG001|Baseline|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
11090319|NCT01528332|BG002|Baseline|Total|Total of all reporting groups
11090320|NCT01528332|FG000|Participant Flow|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
11090321|NCT01528332|FG001|Participant Flow|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
11090322|NCT01528332|OG000|Outcome|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
11090323|NCT01528332|OG001|Outcome|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
11090324|NCT01528332|EG000|Reported Event|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
11090325|NCT01528332|EG001|Reported Event|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
11090326|NCT01528345|BG000|Baseline|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
11090327|NCT01528345|BG001|Baseline|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
11090328|NCT01528345|BG002|Baseline|Total|Total of all reporting groups
11090329|NCT01528345|FG000|Participant Flow|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
11090330|NCT01528345|FG001|Participant Flow|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
11090331|NCT01528345|OG000|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
11090332|NCT01528345|OG001|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
11090333|NCT01528345|EG000|Reported Event|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
11090334|NCT01528345|EG001|Reported Event|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
11090335|NCT01528592|BG000|Baseline|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
11090336|NCT01528592|FG000|Participant Flow|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
11090337|NCT01528592|OG000|Outcome|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
11090338|NCT01528592|EG000|Reported Event|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
11090339|NCT01528605|BG000|Baseline|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
11090340|NCT01528605|BG001|Baseline|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
11090341|NCT01528605|BG002|Baseline|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
11090342|NCT01528605|BG003|Baseline|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
11090343|NCT01528605|BG004|Baseline|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
11090344|NCT01528605|BG005|Baseline|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
11090345|NCT01528605|BG006|Baseline|Total|Total of all reporting groups
11090346|NCT01528605|FG000|Participant Flow|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
11090347|NCT01528605|FG001|Participant Flow|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
11090348|NCT01528605|FG002|Participant Flow|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
11090349|NCT01528605|FG003|Participant Flow|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
11090350|NCT01528605|FG004|Participant Flow|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
11090351|NCT01528605|FG005|Participant Flow|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
11090352|NCT01528605|OG000|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
11090353|NCT01528605|OG001|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
11090354|NCT01528605|OG002|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
11090355|NCT01528605|OG003|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
11090356|NCT01528605|OG004|Outcome|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
11090357|NCT01528605|OG005|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
11090358|NCT01528605|EG000|Reported Event|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
11090359|NCT01528605|EG001|Reported Event|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
11090360|NCT01528605|EG002|Reported Event|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
11090361|NCT01528605|EG003|Reported Event|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
11090362|NCT01528605|EG004|Reported Event|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
11090363|NCT01528605|EG005|Reported Event|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
11090364|NCT01528709|BG000|Baseline|High-dose Statin Therapy|"Atorvastatin 80 mg daily~Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year"
11090365|NCT01528709|BG001|Baseline|Moderate-dose Statin Therapy|"Atorvastatin 10 mg daily~Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year"
11090366|NCT01528709|BG002|Baseline|Total|Total of all reporting groups
11090367|NCT01528709|FG000|Participant Flow|High-dose Statin Therapy|"Atorvastatin 80 mg daily~Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year"
11171292|NCT02002182|OG000|Outcome|Treatment-Vaccine Group|"Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.~ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy."
11171293|NCT02002182|OG001|Outcome|Control Group|Observational control group treated with standard of care therapy only
11171294|NCT02002182|EG000|Reported Event|Treatment-Vaccine Group|"Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.~ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy."
11171295|NCT02002182|EG001|Reported Event|Control Group|Observational control group treated with standard of care therapy only
11171296|NCT02002208|BG000|Baseline|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
10893176|NCT00531661|BG000|Baseline|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
10893177|NCT00531661|BG001|Baseline|Control|CONTROL group: standard of care HF management
10893178|NCT00531661|BG002|Baseline|Total|Total of all reporting groups
11171297|NCT02002208|BG001|Baseline|Placebo Tablets|"Orally once a day~OC000459: CRTH2 inhibitor"
11171298|NCT02002208|BG002|Baseline|Total|Total of all reporting groups
11171299|NCT02002208|FG000|Participant Flow|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
11171300|NCT02002208|FG001|Participant Flow|Placebo Tablets|"Orally once a day~OC000459: CRTH2 inhibitor"
10893179|NCT00531661|FG000|Participant Flow|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
10893180|NCT00531661|FG001|Participant Flow|Control|CONTROL group: standard of care HF management
10893181|NCT00531661|OG000|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
10893182|NCT00531661|OG001|Outcome|Control|CONTROL group: standard of care HF management
10893183|NCT00531661|OG000|Outcome|Entire Study Cohort|
10893184|NCT00531661|OG000|Outcome|Entire Randomized Study Cohort|
10893185|NCT00531661|OG000|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
10893186|NCT00531661|EG000|Reported Event|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
11171301|NCT02002208|OG000|Outcome|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
11171302|NCT02002208|OG001|Outcome|Placebo Tablets|Orally once a day
10893187|NCT00531661|EG001|Reported Event|Control|CONTROL group: standard of care HF management
10893188|NCT00531752|BG000|Baseline|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
10893189|NCT00531752|BG001|Baseline|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
10893190|NCT00531752|BG002|Baseline|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
10893191|NCT00531752|BG003|Baseline|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
10893192|NCT00531752|BG004|Baseline|Total|Total of all reporting groups
10893193|NCT00531752|FG000|Participant Flow|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
11171303|NCT02002208|EG000|Reported Event|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
11171304|NCT02002208|EG001|Reported Event|Placebo Tablets|Orally once a day
11171305|NCT02002221|BG000|Baseline|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
11171306|NCT02002221|BG001|Baseline|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
11171307|NCT02002221|BG002|Baseline|Total|Total of all reporting groups
11171308|NCT02002221|FG000|Participant Flow|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
11171309|NCT02002221|FG001|Participant Flow|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
10893194|NCT00531752|FG001|Participant Flow|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
10893195|NCT00531752|FG002|Participant Flow|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
10893196|NCT00531752|FG003|Participant Flow|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
10893197|NCT00531752|OG000|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
11090368|NCT01528709|FG001|Participant Flow|Moderate-dose Statin Therapy|"Atorvastatin 10 mg daily~Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year"
11090369|NCT01528709|OG000|Outcome|High-dose Statin Therapy|"Atorvastatin 80 mg daily~Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year"
10893198|NCT00531752|OG001|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in first or second DB intervention period.
10893199|NCT00531752|OG002|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
11090370|NCT01528709|OG001|Outcome|Moderate-dose Statin Therapy|"Atorvastatin 10 mg daily~Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year"
11090371|NCT01528709|EG000|Reported Event|High-dose Statin Therapy|"Atorvastatin 80 mg daily~Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year"
11090372|NCT01528709|EG001|Reported Event|Moderate-dose Statin Therapy|"Atorvastatin 10 mg daily~Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year"
11090373|NCT01528735|BG000|Baseline|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
11090374|NCT01528735|BG001|Baseline|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
11090375|NCT01528735|BG002|Baseline|Total|Total of all reporting groups
11090376|NCT01528735|FG000|Participant Flow|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
11090377|NCT01528735|FG001|Participant Flow|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
11090378|NCT01528735|OG000|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
11090379|NCT01528735|OG001|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
10893200|NCT00531752|EG000|Reported Event|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
10893201|NCT00531752|EG001|Reported Event|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in first or second DB intervention period.
10893202|NCT00531752|EG002|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
10893203|NCT00531817|BG000|Baseline|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
10893204|NCT00531817|BG001|Baseline|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
10893205|NCT00531817|BG002|Baseline|Total|Total of all reporting groups
10893206|NCT00531817|FG000|Participant Flow|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
10893207|NCT00531817|FG001|Participant Flow|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
11171310|NCT02002221|OG000|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
11171311|NCT02002221|OG001|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
11171312|NCT02002221|EG000|Reported Event|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
11171313|NCT02002221|EG001|Reported Event|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
11171314|NCT02002494|BG000|Baseline|Volunteers in Different Positions|"The following will be compared in the same volunteer:~Bilateral internal jugular venous flow in supine and prone position~Bilateral internal jugular venous flow in supine and park bench position~Bilateral internal jugular venous flow in prone and park bench~Different positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench"
11171315|NCT02002494|FG000|Participant Flow|Volunteers in Different Positions|"The following will be compared in the same volunteer:~Bilateral internal jugular venous flow in supine and prone position~Bilateral internal jugular venous flow in supine and park bench position~Bilateral internal jugular venous flow in prone and park bench Different positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench"
11171316|NCT02002494|OG000|Outcome|R IJV|Comparisons of right internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and prone position.
11171317|NCT02002494|OG001|Outcome|L IJV|Comparisons of left internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and prone position.
11171318|NCT02002494|OG000|Outcome|R IJV|"- We studied R IJV flow in the supine and right park bench positions respectively.~all measurements were performed on the right eye in a neutral gaze.~- We standardised the use of the right side because of ease of access to that side in the laboratory."
11171319|NCT02002494|OG001|Outcome|L IJV|"- We studied L IJV flow in the supine and right park bench positions respectively.~all measurements were performed on the right eye in a neutral gaze.~- We standardised the use of the right side because of ease of access to that side in the laboratory."
11171320|NCT02002494|OG000|Outcome|R IJV|Comparisons of right internal jugular vein (IJV) Doppler velocity between supine and prone position.
11171321|NCT02002494|OG001|Outcome|L IJV|Comparisons of left internal jugular vein (IJV) Doppler velocity between supine and prone position.
11171322|NCT02002494|OG000|Outcome|R IJV|Comparisons of right internal jugular vein (IJV) flow between supine and prone position.
11171323|NCT02002494|OG001|Outcome|L IJV|Comparisons of left internal jugular vein (IJV) flow between supine and prone position.
11171324|NCT02002494|OG000|Outcome|R IJV|Comparisons of right internal jugular vein (IJV) Doppler velocity between supine and right park bench position
11171325|NCT02002494|OG001|Outcome|L IJV|Comparisons of left internal jugular vein (IJV) Doppler velocity between supine and right park bench position
11171326|NCT02002494|OG000|Outcome|R IJV|Comparisons of right internal jugular vein (IJV) Flow between supine and right park bench position
11171327|NCT02002494|OG001|Outcome|L IJV|Comparisons of left internal jugular vein (IJV) Flow between supine and right park bench position
11171328|NCT02002494|EG000|Reported Event|Volunteers in Different Positions|"The following will be compared in the same volunteer:~Bilateral internal jugular venous flow in supine and prone position~Bilateral internal jugular venous flow in supine and park bench position~Bilateral internal jugular venous flow in prone and park bench~Different positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench"
11171329|NCT02002533|BG000|Baseline|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
11171330|NCT02002533|BG001|Baseline|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
11171331|NCT02002533|BG002|Baseline|Total|Total of all reporting groups
10893208|NCT00531817|OG000|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
11171332|NCT02002533|FG000|Participant Flow|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
11171333|NCT02002533|FG001|Participant Flow|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
11171334|NCT02002533|OG000|Outcome|All Participants|All people that were enrolled in the study regardless of intervention assigned.
11171335|NCT02002533|OG000|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
10893209|NCT00531817|OG001|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
10893210|NCT00531817|EG000|Reported Event|Tocilizumab + DMARDs|Initially treated with tocilizumab + DMARDs and received ≥ 1 dose of tocilizumab. The tocilizumab + DMARDs group includes all data (double-blind and extended treatment periods) for patients who were initially treated with tocilizumab in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
10893211|NCT00531817|EG001|Reported Event|Placebo/Tocilizumab + DMARDs|Initially treated with placebo + DMARDs then received ≥ 1 dose of tocilizumab. The placebo/tocilizumab + DMARDs group includes all data collected after patients' first infusion of tocilizumab (whether escape therapy or extended treatment) for those who were initially treated with placebo in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
10893212|NCT00531817|EG002|Reported Event|Placebo + DMARDs|Initially treated with placebo + DMARDs and received ≥ 1 dose of placebo. The placebo + DMARDs group includes all data collected while patients were on placebo for those who were initially treated with placebo in the double-blind treatment period.
10893213|NCT00531843|BG000|Baseline|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
10893214|NCT00531843|BG001|Baseline|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
10893215|NCT00531843|BG002|Baseline|Total|Total of all reporting groups
10893216|NCT00531843|FG000|Participant Flow|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg via subcutaneous administration (SubQ) daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
10893217|NCT00531843|FG001|Participant Flow|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary inferior vena cava (IVC) filter (prn as determined by caregiver).
10893218|NCT00531843|OG000|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
10893219|NCT00531843|OG001|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
10893220|NCT00531843|EG000|Reported Event|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
10893221|NCT00531843|EG001|Reported Event|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
10893222|NCT00531882|BG000|Baseline|1-Pioglitazone|"Pioglitazone~Pioglitazone: 30 mg once a day"
10893223|NCT00531882|BG001|Baseline|2-Simvastin|"Simvastatin~Simvastatin: 40 mg once a day"
11090380|NCT01528735|EG000|Reported Event|Faldap/Del/RBV:80mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
11090381|NCT01528735|EG001|Reported Event|Faldap/Del/RBV:120mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
10893224|NCT00531882|BG002|Baseline|3-Ibuprofen 1000-1600 mg Twice Daily|Ibuprofen 1000-1600 mg twice daily (max 3200 mg/day)
10893225|NCT00531882|BG003|Baseline|Total|Total of all reporting groups
10893226|NCT00531882|FG000|Participant Flow|1-Pioglitazone|"Pioglitazone~Pioglitazone: 30 mg once a day pioglitazone (Actos, Takeda) will be administered orally in a dose of 30 mg once daily. This is the highest recommended dose for initial control of type II diabetes."
10893227|NCT00531882|FG001|Participant Flow|2-Simvastatin|Simvastatin (Zocor): 40 mg once a day will be administered orally in a dose of 49 mg once daily to all subjects. This dose is considered a mid-level adult dose and the maximum pediatric dose recommended for hyperlipidemia.
10893228|NCT00531882|FG002|Participant Flow|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|Ibuprofen will be used as the positive control for this study. Ibuprofen (Motrin, Pharmacia) will be administered twice daily.
10893229|NCT00531882|OG000|Outcome|1-Pioglitazone|"Pioglitazone~Pioglitazone: 30 mg once a day"
10893230|NCT00531882|OG001|Outcome|2-Simvastatin|"Simvastatin~Simvastatin: 40 mg once a day"
10893231|NCT00531882|OG002|Outcome|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|"Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day~Ibuprofen: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day"
10893232|NCT00531882|EG000|Reported Event|1-Pioglitazone|"Pioglitazone~Pioglitazone: 30 mg once a day"
10893233|NCT00531882|EG001|Reported Event|2-Simvastin|"Simvastatin~Simvastatin: 40 mg once a day"
10893234|NCT00531882|EG002|Reported Event|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|"Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day~Ibuprofen: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day"
10893235|NCT00531934|BG000|Baseline|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
10893236|NCT00531934|BG001|Baseline|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
10893237|NCT00531934|BG002|Baseline|Total|Total of all reporting groups
10893238|NCT00531934|FG000|Participant Flow|Erlotinib Plus (+) Doxycycline|Participants received erlotinib 150 milligrams per day (mg/day), tablets, orally (PO) until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
10893239|NCT00531934|FG001|Participant Flow|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
10893240|NCT00531934|OG000|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
10893241|NCT00531934|OG001|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
10893242|NCT00531934|EG000|Reported Event|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
10893243|NCT00531934|EG001|Reported Event|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
10893244|NCT00531947|BG000|Baseline|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
10893245|NCT00531947|BG001|Baseline|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
10893246|NCT00531947|BG002|Baseline|Total|Total of all reporting groups
10893247|NCT00531947|FG000|Participant Flow|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
10893248|NCT00531947|FG001|Participant Flow|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
10893249|NCT00531947|OG000|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
10893250|NCT00531947|OG001|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
10893251|NCT00531947|EG000|Reported Event|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
10893252|NCT00531947|EG001|Reported Event|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
10893253|NCT00531960|BG000|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
10893254|NCT00531960|BG001|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
10893255|NCT00531960|BG002|Baseline|Total|Total of all reporting groups
10893256|NCT00531960|FG000|Participant Flow|Bevacizumab Plus (+) Chemotherapy|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 milligrams per square meter [mg/m^2], IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 milligrams per milliliter multiplied by minute [mg/mL*min] on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
10893257|NCT00531960|FG001|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
10893258|NCT00531960|OG000|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
10893259|NCT00531960|OG001|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
11090382|NCT01528735|EG002|Reported Event|Faldap/pegIFN/RBV:80mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir (faldap) in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
10893260|NCT00531960|EG000|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
10893261|NCT00531960|EG001|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
10893262|NCT00532129|BG000|Baseline|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
10893263|NCT00532129|FG000|Participant Flow|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles (28 day cycles). Participants who did not achieve complete response (CR) after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 milligrams per square meter per day (mg/m^2/day) oral administration (PO) on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
10893264|NCT00532129|OG000|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
10893265|NCT00532129|EG000|Reported Event|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
10893266|NCT00532155|BG000|Baseline|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
10893267|NCT00532155|BG001|Baseline|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
10893268|NCT00532155|BG002|Baseline|Total|Total of all reporting groups
10893269|NCT00532155|FG000|Participant Flow|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
10893270|NCT00532155|FG001|Participant Flow|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
10893271|NCT00532155|OG000|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
10893272|NCT00532155|OG001|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
11171336|NCT02002533|OG001|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
10893273|NCT00532155|EG000|Reported Event|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
10893274|NCT00532155|EG001|Reported Event|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
10893275|NCT00532259|BG000|Baseline|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
10893276|NCT00532259|FG000|Participant Flow|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
10893277|NCT00532259|OG000|Outcome|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
10893278|NCT00532259|OG000|Outcome|CT-011|CT-011: IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
10893279|NCT00532259|EG000|Reported Event|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
10893280|NCT00532298|BG000|Baseline|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
10893281|NCT00532298|BG001|Baseline|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
10893282|NCT00532298|BG002|Baseline|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
10893283|NCT00532298|BG003|Baseline|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
10893284|NCT00532298|BG004|Baseline|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
10893285|NCT00532298|BG005|Baseline|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
10893286|NCT00532298|BG006|Baseline|Total|Total of all reporting groups
10893287|NCT00532298|FG000|Participant Flow|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
10893288|NCT00532298|FG001|Participant Flow|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
10893289|NCT00532298|FG002|Participant Flow|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
10893290|NCT00532298|FG003|Participant Flow|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
10893291|NCT00532298|FG004|Participant Flow|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
10893292|NCT00532298|FG005|Participant Flow|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
10893293|NCT00532298|OG000|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
10893294|NCT00532298|OG001|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
10893295|NCT00532298|OG002|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
10893296|NCT00532298|OG003|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
10893297|NCT00532298|OG004|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
10893298|NCT00532298|OG005|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
10893299|NCT00532298|EG000|Reported Event|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
10893300|NCT00532298|EG001|Reported Event|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
10893301|NCT00532298|EG002|Reported Event|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
10893302|NCT00532298|EG003|Reported Event|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
10893303|NCT00532298|EG004|Reported Event|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
10893304|NCT00532298|EG005|Reported Event|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
10893305|NCT00532441|BG000|Baseline|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
10893306|NCT00532441|FG000|Participant Flow|Hepatocellular|erlotinib and docetaxel
10893307|NCT00532441|FG001|Participant Flow|Biliary|erlotinib and docetaxel
10893308|NCT00532441|OG000|Outcome|Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
10893309|NCT00532441|OG001|Outcome|Hepatocellular|Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
10893310|NCT00532441|OG000|Outcome|Erlotinib and Docetaxel: Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
10893311|NCT00532441|OG001|Outcome|Erlotinib and Docetaxel: Hepatocellular|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
10893312|NCT00532441|OG000|Outcome|Hepatocellular|erlotinib and docetaxel
10893313|NCT00532441|OG001|Outcome|Biliary|erlotinib and docetaxel
10893314|NCT00532441|EG000|Reported Event|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
10893315|NCT00532480|BG000|Baseline|Duloxetine|Duloxetine : 60 mg capsules
10893316|NCT00532480|FG000|Participant Flow|Duloxetine|Duloxetine 60 mg capsules orally daily open label
11171337|NCT02002533|EG000|Reported Event|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
10893317|NCT00532480|OG000|Outcome|Duloxetine|Duloxetine : 60 mg capsules
10893318|NCT00532480|EG000|Reported Event|Duloxetine|Duloxetine : 60 mg capsules
11171338|NCT02002533|EG001|Reported Event|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
10893319|NCT00532493|BG000|Baseline|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
10893320|NCT00532493|BG001|Baseline|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
10893321|NCT00532493|BG002|Baseline|Total|Total of all reporting groups
10893322|NCT00532493|FG000|Participant Flow|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
10893323|NCT00532493|FG001|Participant Flow|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
10893324|NCT00532493|OG000|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
10893325|NCT00532493|OG001|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
10893326|NCT00532493|OG000|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
10893327|NCT00532493|OG001|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
10893328|NCT00532493|EG000|Reported Event|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
10893329|NCT00532493|EG001|Reported Event|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
10893330|NCT00532779|BG000|Baseline|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
10893331|NCT00532779|BG001|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
10893332|NCT00532779|BG002|Baseline|Placebo|Placebo
10893333|NCT00532779|BG003|Baseline|Total|Total of all reporting groups
10893334|NCT00532779|FG000|Participant Flow|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
10893335|NCT00532779|FG001|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
10893336|NCT00532779|FG002|Participant Flow|Placebo|Placebo
10893337|NCT00532779|OG000|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
10893338|NCT00532779|OG001|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
10893339|NCT00532779|OG002|Outcome|Placebo|Placebo
10893340|NCT00532779|EG000|Reported Event|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
10893341|NCT00532779|EG001|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
10893342|NCT00532779|EG002|Reported Event|Placebo|Placebo
10893343|NCT00532844|BG000|Baseline|Sapropterin Dihydrochloride 10mg/kg First, Then Sapropterin Dihydrochloride 10mg/kg and Vitamin C|"Sequence A: Sapropterin dihydrochloride as the first treatment followed by sapropterin dihydrochloride and vitamin C~Treatment Regimen 1: Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14.~Treatment Regimen 2: Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 28~The washout period of 1 day comprised between treatment regimens."
10893344|NCT00532844|BG001|Baseline|Sapropterin Dihydrochloride 10mg/kg and Vitamin C First, Then Sapropterin Dihydrochloride 10mg/kg|"Sequence B: Sapropterin dihydrochloride and vitamin C as the first treatment followed by sapropterin dihydrochloride~Treatment Regimen 2: Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14.~Treatment Regimen 1: Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal Day 28.~The washout period of 1 day comprised between treatment regimens."
10893345|NCT00532844|BG002|Baseline|Total|Total of all reporting groups
10893346|NCT00532844|FG000|Participant Flow|Sapropterin Dihydrochloride 10mg/kg First; Then Sapropterin Dihydrochloride 10mg/kg and Vitamin C|"Sequence A: Sapropterin dihydrochloride as the first treatment followed by sapropterin dihydrochloride and vitamin C~Treatment Regimen 1: Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14.~Treatment Regimen 2: Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 28~The washout period of 1 day comprised between treatment regimens."
10893347|NCT00532844|FG001|Participant Flow|Sapropterin Dihydrochloride 10mg/kg and Vitamin C First; Then Sapropterin Dihydrochloride 10mg/kg|"Sequence B: Sapropterin dihydrochloride and vitamin C as the first treatment followed by sapropterin dihydrochloride.~Treatment Regimen 2: Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14.~Treatment Regimen 1: Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal Day 28.~The washout period of 1 day comprised between treatment regimens."
10893348|NCT00532844|OG000|Outcome|Sapropterin Dihydrochloride 10 mg/kg|Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893349|NCT00532844|OG001|Outcome|Sapropterin Dihydrochloride+Vitamin C 10 mg/kg|Sapropterin dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893350|NCT00532844|OG000|Outcome|Sapropterin Dihydrochloride|Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893351|NCT00532844|OG001|Outcome|Sapropterin Dihydrochloride+Vitamin C|Sapropterin dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893352|NCT00532844|OG000|Outcome|(Sapropterin Dihydrochloride+Vitamin C)/(Sapropterin Dihydrochloride)|Ratio of Mean AUC (0-12hours) for all subjects (44) receiving sapropterin dihydochloride + Vitamin C/ Mean AUC (0-12 hours) for all subjects (43) receiving sapropterin dihydochloride alone.
10893353|NCT00532844|OG000|Outcome|Sapropterin Dihydrochloride 10mg/kg|"Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.~The washout period of 1 day comprised between treatment regimens."
10893354|NCT00532844|OG001|Outcome|Sapropterin Dihydrochloride 10mg/kg and Vitamin C|Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28
11090383|NCT01528735|EG003|Reported Event|Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
11090384|NCT01528787|BG000|Baseline|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the morning (AM)
11090385|NCT01528787|BG001|Baseline|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the morning (AM)
11090386|NCT01528787|BG002|Baseline|AR-13324 Ophthalmic Solution 0.04%|1 drop to study eye once daily (QD) in the morning (AM)
11090387|NCT01528787|BG003|Baseline|AR-13324 Ophthalmic Solution Vehicle|1 drop to study eye once daily (QD) in the morning (AM)
10893355|NCT00532844|OG000|Outcome|Sapropterin dihydrochloride10mg/kg|Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893356|NCT00532844|OG001|Outcome|Sapropterin Dihydrochloride 10mg/kg and Vitamin C|Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28..
10893357|NCT00532844|OG000|Outcome|Sapropterin dihydrochloride10mg/kg|Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28..
10893358|NCT00532844|OG000|Outcome|Sapropterin Dihydrochloride 10mg/kg|Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893359|NCT00532844|OG001|Outcome|Sapropterin dihydrochloride10mg/kg and Vitamin C|Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28..
10893360|NCT00532844|OG000|Outcome|Sapropterin Dihydrochloride 10mg/kg Vitamin C|Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893361|NCT00532844|OG001|Outcome|Sapropterin dihydrochloride10mg/kg and Vitamin C|Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893362|NCT00532844|OG001|Outcome|Sapropterin Dihydrochloride 10mg/kg and Vitamin C|Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 or Day 28.
10893363|NCT00532844|EG000|Reported Event|Sapropterin Dihydrochloride 10mg/kg|"Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14.~The washout period of 1 day comprised between treatment regimens."
10893364|NCT00532844|EG001|Reported Event|Sapropterin Dihydrochloride 10mg/kg and Vitamin C|"Sapropterin dihydrochloride 5 mg/kg + 500 mg vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14.~The washout period of 1 day comprised between treatment regimens."
10893365|NCT00532883|BG000|Baseline|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
10893366|NCT00532883|BG001|Baseline|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
10893367|NCT00532883|BG002|Baseline|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
10893368|NCT00532883|BG003|Baseline|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
10893369|NCT00532883|BG004|Baseline|Total|Total of all reporting groups
10893370|NCT00532883|FG000|Participant Flow|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
10893371|NCT00532883|FG001|Participant Flow|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
10893372|NCT00532883|FG002|Participant Flow|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
10893373|NCT00532883|FG003|Participant Flow|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
10893374|NCT00532883|OG000|Outcome|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
10893375|NCT00532883|OG001|Outcome|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
10893376|NCT00532883|OG002|Outcome|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
10893377|NCT00532883|OG003|Outcome|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
10893378|NCT00532883|EG000|Reported Event|Hydroxyurea/Magnesium Pidolate|20 mg/kg/day
10893379|NCT00532883|EG001|Reported Event|Hydroxyurea/Placebo|0.6 mEq/kg/day
10893380|NCT00532883|EG002|Reported Event|Placebo/Magnesium Pidolate|20 mg/kg/day HU + 0.6 mEq/kg/day Mg
10893381|NCT00532883|EG003|Reported Event|Placebo/Placebo|
10893382|NCT00532935|BG000|Baseline|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
10893383|NCT00532935|BG001|Baseline|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
10893384|NCT00532935|BG002|Baseline|Total|Total of all reporting groups
10914767|NCT00632749|FG012|Participant Flow|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11090388|NCT01528787|BG004|Baseline|Total|Total of all reporting groups
11090389|NCT01528787|FG000|Participant Flow|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the morning (AM)
11090390|NCT01528787|FG001|Participant Flow|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the morning (AM)
11090391|NCT01528787|FG002|Participant Flow|AR-13324 Ophthalmic Solution 0.04%|1 drop to study eye once daily (QD) in the morning (AM)
10893385|NCT00532935|FG000|Participant Flow|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
10893386|NCT00532935|FG001|Participant Flow|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
10893387|NCT00532935|OG000|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
10893388|NCT00532935|OG001|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
10893389|NCT00532935|EG000|Reported Event|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
10893390|NCT00532935|EG001|Reported Event|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
10893391|NCT00532948|BG000|Baseline|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
10893392|NCT00532948|BG001|Baseline|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
10893393|NCT00532948|BG002|Baseline|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
10893394|NCT00532948|BG003|Baseline|Total|Total of all reporting groups
10893395|NCT00532948|FG000|Participant Flow|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
10893396|NCT00532948|FG001|Participant Flow|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
10893397|NCT00532948|FG002|Participant Flow|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
10893398|NCT00532948|OG000|Outcome|Capecitabine (Overall)|Capecitabine 500, 650, and 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893399|NCT00532948|OG000|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893400|NCT00532948|OG001|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893401|NCT00532948|OG002|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893402|NCT00532948|OG000|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893403|NCT00532948|OG001|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893404|NCT00532948|OG002|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893405|NCT00532948|EG000|Reported Event|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893406|NCT00532948|EG001|Reported Event|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893407|NCT00532948|EG002|Reported Event|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
10893408|NCT00533117|BG000|Baseline|Dialectical Behavior Therapy Fluoxetine|"Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated~Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
10893409|NCT00533117|BG001|Baseline|Dialectical Behavior Therapy Placebo|"Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
10893410|NCT00533117|BG002|Baseline|Supportive Therapy Fluoxetine|"Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated~Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
10893411|NCT00533117|BG003|Baseline|Supportive Therapy Placebo|"Supportive psychotherapy and placebo See above for descriptions.~Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
10893412|NCT00533117|BG004|Baseline|Total|Total of all reporting groups
10893413|NCT00533117|FG000|Participant Flow|DBT Fluoxetine|"Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated~Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
10893414|NCT00533117|FG001|Participant Flow|DBT Placebo|"Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
10893415|NCT00533117|FG002|Participant Flow|Supportive Therapy Fluoxetine|"Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated~Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
10893416|NCT00533117|FG003|Participant Flow|Supportive Therapy Placebo|"Supportive psychotherapy and placebo See above for descriptions.~Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
10893417|NCT00533117|OG000|Outcome|Dialectical Behavior Therapy With Fluoxetine|Participants received 12 months of DBT and Fluoxetine medication with weekly medication visits (medication condition double blind)
10893418|NCT00533117|OG001|Outcome|Dialectical Behavior Therapy With Placebo|Participants received 12 months of DBT and placebo with weekly medication visits (medication condition double blind)
10893419|NCT00533117|OG002|Outcome|Supportive Therapy With Fluoxetine|Participants received 12 months of ST with fluoxetine medication with weekly medication visits (medication condition double blind)
10893420|NCT00533117|OG003|Outcome|Supportive Therapy With Placebo|Participants received 12 months of ST placebo medication with weekly medication visits (medication condition double blind)
10893421|NCT00533117|EG000|Reported Event|Dialectical Behavior Therapy With Fluoxetine|Participants received 12 months of DBT therapy with fluoxetine with weekly medication management sessions (double blind). Primary planned analyses were with supportive therapy/placebo. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups.
11090392|NCT01528787|FG003|Participant Flow|AR-13324 Opththalmic Solution Vehicle|1 drop to study eye once daily (QD) in the morning (AM)
11090393|NCT01528787|OG000|Outcome|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the morning (AM)
11090394|NCT01528787|OG001|Outcome|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the morning (AM)
10893422|NCT00533117|EG001|Reported Event|Supportive Therapy With Fluoxetine|Participants received 12 months of supportive therapy with fluoxetine weekly medication management sessions(double blind). Planned analyses were with supportive therapy/placebo. Also, fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo. to test the hypothesis regarding differences in the primary outcome measure between the two medication groups..
10893423|NCT00533117|EG002|Reported Event|Dialectical Behavior Therapy With Placebo|Participants received 12 months of DBT therapy with placebo medication with weekly medication management sessions (double blind). Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups.
10893424|NCT00533117|EG003|Reported Event|Supportive Therapy With Placebo|Participants received 12 months of supportive therapy with placebo weekly medication management sessions(double blind). This condition served as the control condition. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups.
10893425|NCT00533273|BG000|Baseline|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
10893426|NCT00533273|BG001|Baseline|Placebo|Placebo (Sucrose and Tris) injection
10893427|NCT00533273|BG002|Baseline|Total|Total of all reporting groups
10893428|NCT00533273|FG000|Participant Flow|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10893429|NCT00533273|FG001|Participant Flow|Placebo|Placebo (Sucrose and Tris) injection
10893430|NCT00533273|OG000|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
10893431|NCT00533273|OG001|Outcome|Placebo|Placebo (Sucrose and Tris) injection
10893432|NCT00533273|EG000|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10893433|NCT00533273|EG001|Reported Event|Placebo|Placebo injection is comprised of sucrose and Tris
10893434|NCT00533429|BG000|Baseline|Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin|"Combination biochemotherapy:~Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: Area under the curve (AUC) 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 milligrams/kilogram (mg/kg) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 (28 days), followed by 500 mg oral daily dose for 3 cycles~Maintenance therapy:~Enzastaurin: 500 mg oral daily dose for 21-day cycles until disease progression~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression"
11090395|NCT01528787|OG002|Outcome|AR-13324 Ophthalmic Solution 0.04%|1 drop to study eye once daily (QD) in the morning (AM)
11090396|NCT01528787|OG003|Outcome|AR-13324 Ophthalmic Solution Vehicle|1 drop to study eye once daily (QD) in the morning (AM)
11090397|NCT01528787|EG000|Reported Event|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the morning (AM)
11090398|NCT01528787|EG001|Reported Event|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the morning (AM)
11090399|NCT01528787|EG002|Reported Event|AR-13324 Ophthalmic Solution 0.04%|1 drop to study eye once daily (QD) in the morning (AM)
11090400|NCT01528787|EG003|Reported Event|AR-13324 Ophthalmic Solution Vehicle|1 drop to study eye once daily (QD) in the morning (AM)
11090401|NCT01528878|BG000|Baseline|Single Arm Patients With HCC or Liver Metastases|Patients with hepatocellular carcinoma (HCC) who are not appropriate for surgical resection or radiofrequency ablation (RFA) as a bridge to transplant. The original cohort was not analyzed between good vs compromised liver function because there were only 2 patients with Child-Pugh Class B and secondary outcomes measured are thought to be more influenced by disease rather than liver function (which may be more relevant for toxicity).
11090402|NCT01528878|FG000|Participant Flow|Single Arm Patients With HCC or Liver Metastases|Patients with hepatocellular carcinoma (HCC) who are not appropriate for surgical resection or radiofrequency ablation (RFA) as a bridge to transplant. The original cohort was not analyzed between good vs compromised liver function because there were only 2 patients with Child-Pugh Class B and secondary outcomes measured are thought to be more influenced by disease rather than liver function (which may be more relevant for toxicity).
11090403|NCT01528878|OG000|Outcome|Grade 2 Adverse Events|Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)
11090404|NCT01528878|OG001|Outcome|Grade 3 Adverse Events|Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
11090405|NCT01528878|OG000|Outcome|Single Arm Patients With HCC or Liver Metastases|Patients with hepatocellular carcinoma (HCC) who are not appropriate for surgical resection or radiofrequency ablation (RFA) as a bridge to transplant. The original cohort was not analyzed between good vs compromised liver function because there were only 2 patients with Child-Pugh Class B and secondary outcomes measured are thought to be more influenced by disease rather than liver function (which may be more relevant for toxicity).
11090406|NCT01528878|EG000|Reported Event|Single Arm Patients With HCC or Liver Metastases|Patients with hepatocellular carcinoma (HCC) who are not appropriate for surgical resection or radiofrequency ablation (RFA) as a bridge to transplant. The original cohort was not analyzed between good vs compromised liver function because there were only 2 patients with Child-Pugh Class B and secondary outcomes measured are thought to be more influenced by disease rather than liver function (which may be more relevant for toxicity).
10893435|NCT00533429|BG001|Baseline|Pemetrexed + Carboplatin + Bevacizumab + Placebo|"Combination biochemotherapy:~Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles~Maintenance therapy:~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression~Placebo: Oral tablets daily for 21-day cycles until progressive disease"
10893436|NCT00533429|BG002|Baseline|Total|Total of all reporting groups
10893437|NCT00533429|FG000|Participant Flow|Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin|"Combination biochemotherapy:~Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: Area under the curve (AUC) 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 milligrams/kilogram (mg/kg) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 (28 days), followed by 500 mg oral daily dose for 3 cycles~Maintenance therapy:~Enzastaurin: 500 mg oral daily dose for 21-day cycles until disease progression~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression"
10893438|NCT00533429|FG001|Participant Flow|Pemetrexed + Carboplatin + Bevacizumab + Placebo|"Combination biochemotherapy:~Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles~Maintenance therapy:~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression~Placebo: Oral tablets daily for 21-day cycles until progressive disease"
10893439|NCT00533429|OG000|Outcome|Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin|"Combination biochemotherapy:~Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: Area under the curve (AUC) 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 milligrams/kilogram (mg/kg) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 (28 days), followed by 500 mg oral daily dose for 3 cycles~Maintenance therapy:~Enzastaurin: 500 mg oral daily dose for 21-day cycles until disease progression~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression"
10893440|NCT00533429|OG001|Outcome|Pemetrexed + Carboplatin + Bevacizumab + Placebo|"Combination biochemotherapy:~Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles~Maintenance therapy:~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression~Placebo: Oral tablets daily for 21-day cycles until progressive disease"
10893441|NCT00533429|OG000|Outcome|Enzastaurin + Pemetrexed + Carboplatin + Bevacizumab|"Combination biochemotherapy:~Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: Area under the curve (AUC) 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 milligrams/kilogram (mg/kg) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 (28 days), followed by 500 mg oral daily dose for 3 cycles~Maintenance therapy:~Enzastaurin: 500 mg oral daily dose for 21-day cycles until disease progression~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression"
10893442|NCT00533429|OG001|Outcome|Pemetrexed + Carboplatin + Bevacizumab + Placebo|"Combination biochemotherapy:~Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles~Maintenance therapy:~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycles until disease progression~Placebo: Oral tablets daily for 21-day cycles until progressive"
10893443|NCT00533429|EG000|Reported Event|Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin|"Combination biochemotherapy:~Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: Area under the curve (AUC) 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 milligrams/kilogram (mg/kg) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 (28 days), followed by 500 mg oral daily dose for 3 cycles~Maintenance therapy:~Enzastaurin: 500 mg oral daily dose for 21-day cycles until disease progression~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression"
10914768|NCT00632749|FG013|Participant Flow|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11090407|NCT01528891|BG000|Baseline|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery~Of the 200 patients in this treatment arm, 5 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
10893444|NCT00533429|EG001|Reported Event|Pemetrexed + Carboplatin + Bevacizumab + Placebo|"Combination biochemotherapy:~Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles~Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles~Maintenance therapy:~Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression~Placebo: Oral tablets daily for 21-day cycles until progressive disease"
10893445|NCT00533442|BG000|Baseline|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
10893446|NCT00533442|BG001|Baseline|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
10893447|NCT00533442|BG002|Baseline|Total|Total of all reporting groups
10893448|NCT00533442|FG000|Participant Flow|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
10893449|NCT00533442|FG001|Participant Flow|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
10893450|NCT00533442|OG000|Outcome|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
10893451|NCT00533442|OG001|Outcome|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
10893452|NCT00533442|OG000|Outcome|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
10893453|NCT00533442|OG001|Outcome|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
10893454|NCT00533442|EG000|Reported Event|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
10893455|NCT00533442|EG001|Reported Event|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
10893456|NCT00533507|BG000|Baseline|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
10893457|NCT00533507|FG000|Participant Flow|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
10893458|NCT00533507|OG000|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
10893459|NCT00533507|EG000|Reported Event|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
10893460|NCT00533546|BG000|Baseline|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
10893461|NCT00533546|FG000|Participant Flow|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
11090408|NCT01528891|BG001|Baseline|Placebo|"Normal saline equivalent volume~Placebo~Of the 200 patients in this treatment arm, 2 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
10893462|NCT00533546|OG000|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
10893463|NCT00533546|OG000|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
10893464|NCT00533546|EG000|Reported Event|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
10893465|NCT00533702|BG000|Baseline|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
10893466|NCT00533702|BG001|Baseline|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
10893467|NCT00533702|BG002|Baseline|Total|Total of all reporting groups
10893468|NCT00533702|FG000|Participant Flow|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
10893469|NCT00533702|FG001|Participant Flow|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
10893470|NCT00533702|OG000|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
10893471|NCT00533702|OG001|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
10893472|NCT00533702|EG000|Reported Event|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
10893473|NCT00533702|EG001|Reported Event|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
10893474|NCT00533845|BG000|Baseline|Bupivacaine|"On-Q pump containing Bupivacaine implanted~On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally"
10893475|NCT00533845|BG001|Baseline|Placebo/Control|Saline used in the implanted On-Q device
10893476|NCT00533845|BG002|Baseline|Total|Total of all reporting groups
10893477|NCT00533845|FG000|Participant Flow|Bupivacaine|"On-Q pump containing Bupivacaine implanted~On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally"
10893478|NCT00533845|FG001|Participant Flow|Placebo/Control|Saline used in the implanted On-Q device
10893479|NCT00533845|OG000|Outcome|Bupivacaine|"On-Q pump containing Bupivacaine implanted~On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally"
10893480|NCT00533845|OG001|Outcome|Placebo/Control|Saline used in the implanted On-Q device
10893481|NCT00533845|EG000|Reported Event|Bupivacaine|"On-Q pump containing Bupivacaine implanted~On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally"
10893482|NCT00533845|EG001|Reported Event|Placebo/Control|Saline used in the implanted On-Q device
10893483|NCT00533897|BG000|Baseline|Period 1 Non-Responders|Participants received abatacept (ABA) intravenous (IV) loading dose and subcutaneous (SC) injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 non-responders skipped Periods 2 and 3 and entered the long term extension (LTE).
10893484|NCT00533897|BG001|Baseline|Abatacept Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to ABA (Day 85-169).
10893485|NCT00533897|BG002|Baseline|Placebo Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to Placebo (Day 85-169).
10893486|NCT00533897|BG003|Baseline|Total|Total of all reporting groups
10893487|NCT00533897|FG000|Participant Flow|Abatacept (ABA) [Lead-In (LI)]|On Day 1 of the 12 week Lead-In (LI), participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
10893488|NCT00533897|FG001|Participant Flow|Abatacept (ABA) Double-blind Withdrawal (DBW)|After receiving ABA in the LI, participants received double blind ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
11090409|NCT01528891|BG002|Baseline|Total|Total of all reporting groups
10893489|NCT00533897|FG002|Participant Flow|Placebo (PLA) Double Blind Withdrawal (DBW)|After receiving ABA in the LI Period, participants received double blind Placebo SC injections starting on Day 85 and weekly for 12 weeks.
10893490|NCT00533897|FG003|Participant Flow|ABA With IV PLA Loading Dose in Re-introduction (RI) Period|After receiving ABA in LI Period, and ABA in DBW Period, participants received a single blinded placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
10893491|NCT00533897|FG004|Participant Flow|PLA Switched to ABA With ABA IV Loading Dose in RI Period|After receiving ABA in LI period, and PLA in the DBW Period, participants were randomized to receive a single weight-titered ABA IV loading dose (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
10893492|NCT00533897|FG005|Participant Flow|PLA Switched to ABA With PLA IV Loading Dose in RI Period|After receiving ABA in the Lead-In, and PLA in the DBW Period, participants were randomized to receive a single Placebo IV loading dose on Day 169 followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
10893493|NCT00533897|FG006|Participant Flow|Long Term Extension Abatacept for LI Period Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve Disease Activity Score 28 (DAS28-CRP) decrease by ≥ 0.6 from Day 1), they directly entered the Long Term Extension (LTE) receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
10893494|NCT00533897|FG007|Participant Flow|Long Term Extension (LTE) Abatacept for Short Term Completers|Participant's who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
10893495|NCT00533897|OG000|Outcome|Abatacept in DBW Period|Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
10893496|NCT00533897|OG001|Outcome|Placebo in DBW Period|Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
10893497|NCT00533897|OG000|Outcome|PLA Switched to ABA With ABA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
10893498|NCT00533897|OG001|Outcome|PLA Switched to ABA With PLA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
10893499|NCT00533897|OG000|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) Abatacept (ABA) dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
10893500|NCT00533897|OG000|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
10893501|NCT00533897|OG000|Outcome|Abatacept in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
10893502|NCT00533897|OG001|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
10893503|NCT00533897|OG000|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
10893504|NCT00533897|OG000|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
10893505|NCT00533897|OG001|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
10893506|NCT00533897|OG000|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
10893507|NCT00533897|OG001|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
10893508|NCT00533897|OG000|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
10893509|NCT00533897|OG001|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
10893510|NCT00533897|OG000|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
10893511|NCT00533897|OG001|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
10893512|NCT00533897|OG000|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
10893513|NCT00533897|OG000|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
10893514|NCT00533897|OG001|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
10893515|NCT00533897|OG002|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
11090410|NCT01528891|FG000|Participant Flow|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
11090411|NCT01528891|FG001|Participant Flow|Placebo|"Normal saline equivalent volume~Placebo"
10893516|NCT00533897|OG000|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
10893517|NCT00533897|OG001|Outcome|LTE Abatacept for Short Term Completers|Participant's who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
10893518|NCT00533897|OG000|Outcome|LTE Abatacept for All Participants|This group includes all participants who received at least one dose of 125 mg SC Abatacept during the LTE and includes both the LI Period 1 non-responder and the ST Completer cohorts.
10893519|NCT00533897|OG001|Outcome|LTE Abatacept for Short Term Completers|Participant's who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
10893520|NCT00533897|EG000|Reported Event|Period 1 Non-Completers|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. These participants did not complete the Period and did not continue in the study.
10893521|NCT00533897|EG001|Reported Event|Period 1 Non-Responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 until completion of the LTE.
10893522|NCT00533897|EG002|Reported Event|Abatacept Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Abatacept SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were continued in Reintroduction Period 3 and during the LTE Period until completion of the LTE.
10893523|NCT00533897|EG003|Reported Event|Placebo Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Placebo SC injections starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were administered during Reintroduction Period 3 and during the LTE Period until completion of the LTE.
10893524|NCT00533910|BG000|Baseline|Placebo|"Will be given placebo and follow the exact procedures as the experimental section~placebo: same as the experimental arm"
10893525|NCT00533910|BG001|Baseline|Rifaximin|Rifaximin: 550mg BID rifaximin for 8 weeks
10893526|NCT00533910|BG002|Baseline|Total|Total of all reporting groups
10893527|NCT00533910|FG000|Participant Flow|Placebo|"Will be given placebo and follow the exact procedures as the experimental section~placebo: same as the experimental arm"
10893528|NCT00533910|FG001|Participant Flow|Rifaximin|Rifaximin: 550mg BID rifaximin for 8 weeks
10893529|NCT00533910|OG000|Outcome|Placebo|"Will be given placebo and follow the exact procedures as the experimental section~placebo: same as the experimental arm"
10893530|NCT00533910|OG001|Outcome|Rifaximin|Rifaximin: 550mg BID rifaximin for 8 weeks
11090412|NCT01528891|OG000|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery"
10893531|NCT00533910|EG000|Reported Event|Placebo|"Will be given placebo and follow the exact procedures as the experimental section~placebo: same as the experimental arm"
10893532|NCT00533910|EG001|Reported Event|Rifaximin|Rifaximin: 550mg BID rifaximin for 8 weeks
10893533|NCT00534001|BG000|Baseline|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
10893534|NCT00534001|BG001|Baseline|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
10893535|NCT00534001|BG002|Baseline|Total|Total of all reporting groups
10893536|NCT00534001|FG000|Participant Flow|1-week Run In (Standard)|
10893537|NCT00534001|FG001|Participant Flow|4-week Run-in (Extended)|
10893538|NCT00534001|OG000|Outcome|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
10893539|NCT00534001|OG001|Outcome|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
10893540|NCT00534001|EG000|Reported Event|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
10893541|NCT00534001|EG001|Reported Event|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
11090413|NCT01528891|OG001|Outcome|Placebo|"Normal saline~Placebo"
10893542|NCT00534092|BG000|Baseline|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
10893543|NCT00534092|BG001|Baseline|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
10893544|NCT00534092|BG002|Baseline|Total|Total of all reporting groups
10893545|NCT00534092|FG000|Participant Flow|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
10893546|NCT00534092|FG001|Participant Flow|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
10893547|NCT00534092|OG000|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
10893548|NCT00534092|OG001|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
10893549|NCT00534092|OG002|Outcome|Total|Total patients included target group and safety group.
10893550|NCT00534092|EG000|Reported Event|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
10893551|NCT00534092|EG001|Reported Event|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
10893552|NCT00534092|EG002|Reported Event|Total|Total patients included target group and safety group.
11090414|NCT01528891|OG000|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
11090415|NCT01528891|OG001|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
11090416|NCT01528891|EG000|Reported Event|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
11090417|NCT01528891|EG001|Reported Event|Placebo|"Normal saline equivalent volume~Placebo"
11090418|NCT01528969|BG000|Baseline|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
10893553|NCT00534105|BG000|Baseline|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
10893554|NCT00534105|BG001|Baseline|Normal Pregnancies|Normal pregnant women without gestational diabetes
10893555|NCT00534105|BG002|Baseline|Total|Total of all reporting groups
10893556|NCT00534105|FG000|Participant Flow|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
10893557|NCT00534105|FG001|Participant Flow|Normal Pregnancies|Normal pregnant women without gestational diabetes
10893558|NCT00534105|OG000|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
10893559|NCT00534105|OG001|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
10893560|NCT00534105|EG000|Reported Event|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
10893561|NCT00534105|EG001|Reported Event|Normal Pregnancies|Normal pregnant women without gestational diabetes
10893562|NCT00534118|BG000|Baseline|Multiple DLI|Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
10893563|NCT00534118|BG001|Baseline|Single DLI|Accruals where the patient received only one donor lymphocyte infusion
10893564|NCT00534118|BG002|Baseline|Total|Total of all reporting groups
10893565|NCT00534118|FG000|Participant Flow|Multiple DLI|Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
10893566|NCT00534118|FG001|Participant Flow|Single DLI|accruals where the patient received only one donor lymphocyte infusion
10893567|NCT00534118|OG000|Outcome|Multiple DLI|Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
10893568|NCT00534118|OG001|Outcome|Single DLI|accruals where the patient received only one donor lymphocyte infusion
10893569|NCT00534118|OG000|Outcome|Multiple DLI - Complete Responders|Duration of time patients who achieved a complete remission by day +100 after DLI maintained that remission
10893570|NCT00534118|OG001|Outcome|Single DLI - Complete Responders|Duration of time patients who achieved a complete remission by day +100 after DLI maintained that remission
10893571|NCT00534118|EG000|Reported Event|Multiple DLI|Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
10893572|NCT00534118|EG001|Reported Event|Single DLI|accruals where the patient received only one donor lymphocyte infusion
10893573|NCT00534209|BG000|Baseline|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
10893574|NCT00534209|FG000|Participant Flow|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
10893575|NCT00534209|OG000|Outcome|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
10893576|NCT00534209|OG000|Outcome|Arm I: Allogeneic B7.1/HLA-A1|"Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally.~Allogeneic B7.1/HLA-A1: Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally"
10893577|NCT00534209|OG001|Outcome|Arm II: Placebo|"Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Placebo: Given intradermally"
11090419|NCT01528969|BG001|Baseline|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
11090420|NCT01528969|BG002|Baseline|Total|Total of all reporting groups
10893578|NCT00534209|EG000|Reported Event|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
10893579|NCT00534235|BG000|Baseline|Posterolateral Fusion w/Pedicle Screws|"Control: Posterolateral fusion and implantation of pedicle screws after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Posterolateral Fusion and Implantation of Pedicle Screws"
10893580|NCT00534235|BG001|Baseline|Coflex Interlaminar Technolgy|"Investigative: Implantation of coflex Interlaminar Technology after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Implantation of coflex Interlaminar Technology"
10893581|NCT00534235|BG002|Baseline|Total|Total of all reporting groups
10893582|NCT00534235|FG000|Participant Flow|Posterolateral Fusion w/Pedicle Screws|"Control: Posterolateral fusion and implantation of pedicle screws after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Posterolateral Fusion and Implantation of Pedicle Screws"
10893583|NCT00534235|FG001|Participant Flow|Coflex Interlaminar Technolgy|"Investigative: Implantation of coflex Interlaminar Technology after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Implantation of coflex Interlaminar Technology"
10893584|NCT00534235|OG000|Outcome|Posterolateral Fusion w/Pedicle Screws|"Control: Posterolateral fusion and implantation of pedicle screws after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Posterolateral Fusion and Implantation of Pedicle Screws"
10893585|NCT00534235|OG001|Outcome|Coflex Interlaminar Technolgy|"Investigative: Implantation of coflex Interlaminar Technology after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Implantation of coflex Interlaminar Technology"
10893586|NCT00534235|OG000|Outcome|Coflex Interlaminar Technolgy|"Investigative: Implantation of coflex Interlaminar Technology after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Implantation of coflex Interlaminar Technology"
10893587|NCT00534235|EG000|Reported Event|Posterolateral Fusion w/Pedicle Screws|"Control: Posterolateral fusion and implantation of pedicle screws after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Posterolateral Fusion and Implantation of Pedicle Screws"
10893588|NCT00534235|EG001|Reported Event|Coflex Interlaminar Technolgy|"Investigative: Implantation of coflex Interlaminar Technology after decompression~Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain~Implantation of coflex Interlaminar Technology"
10893589|NCT00534248|BG000|Baseline|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
11357440|NCT03757988|EG000|Reported Event|Single Arm Experimental Walking Group|"This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.~Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it."
10893590|NCT00534248|BG001|Baseline|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
10893591|NCT00534248|BG002|Baseline|Total|Total of all reporting groups
10893592|NCT00534248|FG000|Participant Flow|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
10893593|NCT00534248|FG001|Participant Flow|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
10893594|NCT00534248|OG000|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
10893595|NCT00534248|OG001|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
10893596|NCT00534248|EG000|Reported Event|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
10893597|NCT00534248|EG001|Reported Event|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
10893598|NCT00534313|BG000|Baseline|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
10893599|NCT00534313|BG001|Baseline|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
10893600|NCT00534313|BG002|Baseline|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
10893601|NCT00534313|BG003|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
10893602|NCT00534313|BG004|Baseline|Total|Total of all reporting groups
11090421|NCT01528969|FG000|Participant Flow|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks."
10893603|NCT00534313|FG000|Participant Flow|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
10893604|NCT00534313|FG001|Participant Flow|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
10893605|NCT00534313|FG002|Participant Flow|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
10893606|NCT00534313|FG003|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
10893607|NCT00534313|OG000|Outcome|All Treated Participants|Long-term period: All participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893608|NCT00534313|OG000|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893609|NCT00534313|OG001|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg). Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893610|NCT00534313|OG002|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893611|NCT00534313|OG003|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893612|NCT00534313|OG000|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893613|NCT00534313|OG001|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
11090422|NCT01528969|FG001|Participant Flow|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks."
11090423|NCT01528969|OG000|Outcome|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
11335624|NCT03554005|OG003|Outcome|PEG Interferon Alfa-2b 4.5 mcg/kg OW|Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10893614|NCT00534313|OG002|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893615|NCT00534313|OG003|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893616|NCT00534313|OG002|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893617|NCT00534313|OG000|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893618|NCT00534313|OG000|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
10893619|NCT00534313|OG001|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg).
10893620|NCT00534313|OG002|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
10893621|NCT00534313|OG003|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
10893622|NCT00534313|OG000|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
10893623|NCT00534313|OG001|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
10893624|NCT00534313|OG002|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
10893625|NCT00534313|OG003|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
10893626|NCT00534313|OG000|Outcome|Abatacept 30/10|Participants who received iv infusions of abatacept (30 mg/kg-calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
10893627|NCT00534313|OG001|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
10893628|NCT00534313|OG002|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
10893629|NCT00534313|OG000|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
10893630|NCT00534313|OG001|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
10893631|NCT00534313|OG002|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
10893632|NCT00534313|OG001|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
10893633|NCT00534313|OG002|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
10893634|NCT00534313|OG003|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
10893635|NCT00534313|OG000|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
10893636|NCT00534313|OG000|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
10893637|NCT00534313|OG002|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose based on their screening visit weight.
10893638|NCT00534313|OG001|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 169. All participants received a dose based on their screening visit weight as per by rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
10893639|NCT00534313|OG000|Outcome|Abatacept 30/10|Participants received calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg.
10893640|NCT00534313|OG001|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
10893641|NCT00534313|OG001|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
10893642|NCT00534313|OG003|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
10893643|NCT00534313|OG000|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg -calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
10893644|NCT00534313|OG001|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000mg).
11090424|NCT01528969|OG001|Outcome|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
10893645|NCT00534313|EG000|Reported Event|Abatacept 10/10 (Short-term Period)|Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
10893646|NCT00534313|EG001|Reported Event|Abatacept 3/3 (Short-term Period)|Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
10893647|NCT00534313|EG002|Reported Event|Abatacept 30/10 (Short-term Period)|Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
10893648|NCT00534313|EG003|Reported Event|Abatacept (Long-term Period)|Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
10893649|NCT00534313|EG004|Reported Event|Placebo (Short-term Period)|Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
10893650|NCT00534352|BG000|Baseline|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
10893651|NCT00534352|FG000|Participant Flow|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
10893652|NCT00534352|OG000|Outcome|Treatment A: TMC125 + TDF/FTC|Treatment A: TMC125 + TDF/FTC.
10893653|NCT00534352|OG001|Outcome|Treatment B: TMC125 + TDF/FTC + DRV/Rtv|Treatment B: TMC125 + TDF/FTC + DRV/rtv.
10893654|NCT00534352|OG000|Outcome|Treatment A|TMC125 + TDF/FTC
10893655|NCT00534352|OG001|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
10893656|NCT00534352|OG002|Outcome|Treatment C|DRV/rtv + TDF/FTC
10893657|NCT00534352|OG003|Outcome|Optional Extension|DRV/rtv + TDF/FTC
10893658|NCT00534352|OG000|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
10893659|NCT00534352|EG000|Reported Event|Treatment A|TMC125 + TDF/FTC
10893660|NCT00534352|EG001|Reported Event|Treatment B|TMC125 + TDF/FTC + DRV/rtv
10893661|NCT00534352|EG002|Reported Event|Treatment C|DRV/rtv + TDF/FTC
10893662|NCT00534352|EG003|Reported Event|Optional Extension|DRV/rtv + TDF/FTC
11090425|NCT01528969|EG000|Reported Event|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.~None of the subjects had any adverse effects of the consumption of the chewing gum."
11090426|NCT01528969|EG001|Reported Event|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.~None of the subjects had any adverse effects of the consumption of the chewing gum."
11090427|NCT01529034|BG000|Baseline|USL261|"5 mg intranasal midazolam~USL261"
11090428|NCT01529034|FG000|Participant Flow|USL261|"5 mg intranasal midazolam~USL261"
10893663|NCT00534365|BG000|Baseline|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
10893664|NCT00534365|BG001|Baseline|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
10893665|NCT00534365|BG002|Baseline|Total|Total of all reporting groups
10893666|NCT00534365|FG000|Participant Flow|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
10893667|NCT00534365|FG001|Participant Flow|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
10893668|NCT00534365|OG000|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
10893669|NCT00534365|OG001|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
10893670|NCT00534365|OG000|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
10893671|NCT00534365|OG001|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
10893672|NCT00534365|EG000|Reported Event|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
10893673|NCT00534365|EG001|Reported Event|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
10893674|NCT00534404|BG000|Baseline|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
11090429|NCT01529034|OG000|Outcome|USL261|"5 mg intranasal midazolam~USL261"
10893675|NCT00534404|BG001|Baseline|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893676|NCT00534404|BG002|Baseline|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893677|NCT00534404|BG003|Baseline|Total|Total of all reporting groups
10893678|NCT00534404|FG000|Participant Flow|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893679|NCT00534404|FG001|Participant Flow|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893680|NCT00534404|FG002|Participant Flow|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893681|NCT00534404|OG000|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893682|NCT00534404|OG001|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893683|NCT00534404|OG002|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893684|NCT00534404|EG000|Reported Event|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893685|NCT00534404|EG001|Reported Event|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893686|NCT00534404|EG002|Reported Event|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
10893687|NCT00534417|BG000|Baseline|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
10893688|NCT00534417|FG000|Participant Flow|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg orally (po) in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
10893689|NCT00534417|OG000|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
10893690|NCT00534417|EG000|Reported Event|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
10893691|NCT00534495|BG000|Baseline|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
10893692|NCT00534495|BG001|Baseline|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
10893693|NCT00534495|BG002|Baseline|Total|Total of all reporting groups
10893694|NCT00534495|FG000|Participant Flow|Rilonacept|Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week followed by a placebo loading dose and then rilonacept in the long term extension phase Rilonacept: 2.2 mg/kg subcutaneously
10893695|NCT00534495|FG001|Participant Flow|Placebo|"Placebo loading dose followed by maintenance dose for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the long term extension~Rilonacept: 2.2 mg/kg subcutaneously"
10893696|NCT00534495|FG002|Participant Flow|Long Term Extension All Participants|All participants who benefited from rilonacept were eligible to enroll this phase and receive rilonacept 2.2mg/kg weekly
10893697|NCT00534495|OG000|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
10893698|NCT00534495|OG001|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
10893699|NCT00534495|OG002|Outcome|Week 24- All Subjects|
10893700|NCT00534495|OG002|Outcome|Long Term Extension 24 Weeks to 21 Months|
10893701|NCT00534495|EG000|Reported Event|Rilonacept Week (0-4)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
10893702|NCT00534495|EG001|Reported Event|Placebo Week (0-4)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
11357441|NCT03757312|BG000|Baseline|Fontan|"Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.~Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD)."
10893703|NCT00534495|EG002|Reported Event|Rilonacept Week (4-24)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
11090430|NCT01529034|OG000|Outcome|USL261|USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode
10893704|NCT00534495|EG003|Reported Event|Placebo Week (4-24)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
10893705|NCT00534495|EG004|Reported Event|Long Term Extension 24 Weeks to 21 Months|
10893706|NCT00534599|BG000|Baseline|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
10893707|NCT00534599|BG001|Baseline|Placebo|Matching placebo tablets once daily
10893708|NCT00534599|BG002|Baseline|Total|Total of all reporting groups
10893709|NCT00534599|FG000|Participant Flow|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
10893710|NCT00534599|FG001|Participant Flow|Placebo|Matching placebo tablets once daily
10893711|NCT00534599|OG000|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
10893712|NCT00534599|OG001|Outcome|Placebo|Matching placebo tablets once daily
10893713|NCT00534599|EG000|Reported Event|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
10893714|NCT00534599|EG001|Reported Event|Placebo|Matching placebo tablets once daily
10893715|NCT00534638|BG000|Baseline|Cervarix Pooled Group|Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893716|NCT00534638|BG001|Baseline|Engerix-B Pooled Group|Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893717|NCT00534638|BG002|Baseline|Total|Total of all reporting groups
10893718|NCT00534638|FG000|Participant Flow|Cervarix Pooled Group|Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893719|NCT00534638|FG001|Participant Flow|Engerix-B Pooled Group|Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893720|NCT00534638|OG000|Outcome|Cervarix/Engerix-B A Group|The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893721|NCT00534638|OG001|Outcome|Cervarix/Engerix-B B Group|The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
11090431|NCT01529034|EG000|Reported Event|USL261|USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode
11357442|NCT03757312|BG001|Baseline|Non-Fontan|Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
11357443|NCT03757312|BG002|Baseline|Total|Total of all reporting groups
11357444|NCT03757312|FG000|Participant Flow|Fontan|"Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.~Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD)."
11357445|NCT03757312|FG001|Participant Flow|Non-Fontan|Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
10893722|NCT00534638|OG002|Outcome|Engerix-B Group|In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893723|NCT00534638|OG000|Outcome|Cervarix/Engerix-B Pooled Group|Pooled A and B group: This pooled group includes subjects from communities where 70% of male and female adolescents (A group) or 70% of female adolescents (B group) were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants (A group) or female participants (B group) to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects (A group) or vaccinated females (B group) were randomized to Cervarix). Finally, subjects from this pooled group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893724|NCT00534638|OG001|Outcome|Engerix-B Group|In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893725|NCT00534638|OG000|Outcome|Cervarix Pooled Group|Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893726|NCT00534638|OG001|Outcome|Engerix-B Pooled Group|Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893727|NCT00534638|EG000|Reported Event|Cervarix Pooled Group|Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893728|NCT00534638|EG001|Reported Event|Engerix-B Pooled Group|Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10893729|NCT00534703|BG000|Baseline|AAV1/SERCA2A|"SERCA gene therapy~AAV1/SERCA2a: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles)"
10893730|NCT00534703|BG001|Baseline|Placebo|"Placebo (saline solution)~Placebo: Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion."
10893731|NCT00534703|BG002|Baseline|Total|Total of all reporting groups
10893732|NCT00534703|FG000|Participant Flow|AAV1/SERCA2A|"SERCA gene therapy~AAV1/SERCA2a: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles)"
10893733|NCT00534703|FG001|Participant Flow|Placebo|"Placebo (saline solution)~Placebo: Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion."
10893734|NCT00534703|OG000|Outcome|AAV1/SERCA2A|"SERCA gene therapy~AAV1/SERCA2a: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles)~No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.~Justification: The trial was terminated early with only 5 subjects enrolled. As a result full statistical analysis for both primary and secondary outcomes was impossible and a more pragmatic approach was undertaken to assess product safety."
10893735|NCT00534703|OG001|Outcome|Placebo|"Placebo (saline solution)~Placebo: Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion.~No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.~Justification: The trial was terminated early with only 5 subjects enrolled. As a result full statistical analysis for both primary and secondary outcomes was impossible and a more pragmatic approach was undertaken to assess product safety."
10893736|NCT00534703|OG000|Outcome|AAV1/SERCA2A|"SERCA gene therapy~AAV1/SERCA2a: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles)"
10893737|NCT00534703|OG001|Outcome|Placebo|"Placebo (saline solution)~Placebo: Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion."
10893738|NCT00534703|EG000|Reported Event|AAV1/SERCA2A|"SERCA gene therapy~AAV1/SERCA2a: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles)"
10893739|NCT00534703|EG001|Reported Event|Placebo|"Placebo (saline solution)~Placebo: Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion."
10893740|NCT00534794|BG000|Baseline|Elestat|1 drop each eye for 2 days
10893741|NCT00534794|BG001|Baseline|Pataday|1 drop each eye for 1 day
10893742|NCT00534794|BG002|Baseline|Total|Total of all reporting groups
10893743|NCT00534794|FG000|Participant Flow|Elestat|1 drop each eye for 2 days
10893744|NCT00534794|FG001|Participant Flow|Pataday|1 drop each eye for 1 day
10893745|NCT00534794|OG000|Outcome|Elestat|1 drop each eye for 2 days
10893746|NCT00534794|OG001|Outcome|Pataday|1 drop each eye for 1 day
10893747|NCT00534794|EG000|Reported Event|Elestat|1 drop each eye for 2 days
10893748|NCT00534794|EG001|Reported Event|Pataday|1 drop each eye for 1 day
11171339|NCT02002650|BG000|Baseline|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
10893749|NCT00534833|BG000|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
11090432|NCT01529060|BG000|Baseline|Phenylbutyrate First and Placebo Second|Individuals randomized to this group received phenylbutyrate (500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in divided doses per day) for 14 days (week 1 and week 2) and then crossed over to receive placebo powder in identical doses for the next 14 days (Week 3 and week 4)
11090433|NCT01529060|BG001|Baseline|Placebo First and Phenylbutyrate Second|Individuals randomized to this group received first received placebo powder for 14 days (week 1 and week 2) and then were crossed over to receive phenylbutyrate (500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in 3 divided doses per day) for 14 days (week 3 and week 4) week 4).
11090434|NCT01529060|BG002|Baseline|Total|Total of all reporting groups
11090435|NCT01529060|FG000|Participant Flow|Phenylbutyrate First and Placebo Second Group|Individuals randomized to this group received phenylbutyrate powder (500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in 3 divided doses per day) for 14 days (week 1 and week 2) and then crossed over to receive placebo powder in identical doses for the next 14 days (Week 3 and week 4)
11090436|NCT01529060|FG001|Participant Flow|Placebo First and Phenylbutyrate Second Group|Individuals randomized to this group received first received placebo powder for 14 days (week 1 and week 2) and then were crossed over to receive phenylbutyrate (500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in 3 divided doses per day) for 14 days (week 3 and week 4) week 4).
10893750|NCT00534833|BG001|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
10893751|NCT00534833|BG002|Baseline|Total|Total of all reporting groups
10893752|NCT00534833|FG000|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
10893753|NCT00534833|FG001|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
10893754|NCT00534833|OG000|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.
10893755|NCT00534833|OG001|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203
10893756|NCT00534833|OG000|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
11090437|NCT01529060|OG000|Outcome|Phenylbutyrate|Cumulative results when individuals were treated with phenylbutyrate
11090438|NCT01529060|OG001|Outcome|Placebo First and Phenylbutyrate Second Group|Cumulative results from when individuals were treated with placebo
11090439|NCT01529060|OG001|Outcome|Placebo|Cumulative results when individuals were treated with placebo
11090440|NCT01529060|EG000|Reported Event|Phenylbutyrate|"Study Drug~Phenylbutyrate: Dosage of phenylbutyrate powder will be 500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in four divided doses per day, the standard UCD dose studied in our preliminary studies, for 14 days."
11090441|NCT01529060|EG001|Reported Event|Inactive Powder|"Placebo powder~Placebo powder: Dosage of inactive placebo powder will be 500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in four divided doses per day for 14 days. Subjects will receive the same amount of powder for each arm of the study."
10893757|NCT00534833|OG001|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
10893758|NCT00534833|EG000|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
10893759|NCT00534833|EG001|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
10893760|NCT00534937|BG000|Baseline|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
10893761|NCT00534937|BG001|Baseline|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
10893762|NCT00534937|BG002|Baseline|Total|Total of all reporting groups
10893763|NCT00534937|FG000|Participant Flow|Standard Compression|Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).
11090442|NCT01529112|BG000|Baseline|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
11090443|NCT01529112|BG001|Baseline|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
11090444|NCT01529112|BG002|Baseline|Total|Total of all reporting groups
10893764|NCT00534937|FG001|Participant Flow|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
11171340|NCT02002650|BG001|Baseline|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
11171341|NCT02002650|BG002|Baseline|Total|Total of all reporting groups
10893765|NCT00534937|OG000|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
10893766|NCT00534937|OG001|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
10893767|NCT00534937|OG001|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
10893768|NCT00534937|OG000|Outcome|Standard Compression|Patients in this arm received current standard of care (once-weekly short-stretch compression wrapping).
10893769|NCT00534937|EG000|Reported Event|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
10893770|NCT00534937|EG001|Reported Event|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
10893771|NCT00535002|BG000|Baseline|Cocaine Females, Yohimbine Then Placebo|Cocaine-dependent females, received yohimbine day 1, placebo day 2
10893772|NCT00535002|BG001|Baseline|Cocaine Females, Placebo Then Yohimbine|Cocaine-dependent females, received placebo day 1, yohimbine day 2
10893773|NCT00535002|BG002|Baseline|Cocaine Males, Yohimbine Then Placebo|Cocaine-dependent males, received yohimbine day 1, placebo day 2
10893774|NCT00535002|BG003|Baseline|Cocaine Males, Placebo Then Yohimbine|Cocaine-dependent males, received placebo day 1, yohimbine day 2
10893775|NCT00535002|BG004|Baseline|Control Females, Yohimbine Then Placebo|non-dependent females, received yohimbine day and placebo day 2
10893776|NCT00535002|BG005|Baseline|Control Females, Placebo Then Yohimbine|non-dependent females, received placebo day and yohimbine day 2
10893777|NCT00535002|BG006|Baseline|Control Males, Yohimbine Then Placebo|non-dependent males, received yohimbine day and placebo day 2
10893778|NCT00535002|BG007|Baseline|Control Males, Placebo Then Yohimbine|non-dependent males, received placebo day and yohimbine day 2
10893779|NCT00535002|BG008|Baseline|Total|Total of all reporting groups
10893780|NCT00535002|FG000|Participant Flow|Cocaine Females, Yohimbine Then Placebo|Cocaine-dependent females, Yohimbine then placebo
10893781|NCT00535002|FG001|Participant Flow|Cocaine Males, Yohimbine Then Placebo|Cocaine-dependent males, Yohimbine then placebo
11171342|NCT02002650|FG000|Participant Flow|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
11171343|NCT02002650|FG001|Participant Flow|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
10893782|NCT00535002|FG002|Participant Flow|Control Females, Yohimbine Then Placebo|Non-dependent females, Yohimbine then placebo
10893783|NCT00535002|FG003|Participant Flow|Control Males, Yohimbine Then Placebo|Non-dependent males, Yohimbine then placebo
10893784|NCT00535002|FG004|Participant Flow|Cocaine Females, Placebo Then Yohimbine|Cocaine females-dependent females, Placebo then yohimbine
10893785|NCT00535002|FG005|Participant Flow|Cocaine Males, Placebo Then Yohimbine|Cocaine-dependent males, Placebo then Yohimbine
10893786|NCT00535002|FG006|Participant Flow|Control Females, Placebo Then Yohimbine|Non-dependent females, placebo then yohimbine
10893787|NCT00535002|FG007|Participant Flow|Control Males, Placebo Then Yohimbine|Non-dependent males, placebo then yohimbine
10893788|NCT00535002|OG000|Outcome|Cocaine Females Yohimbine|Cocaine-dependent females pre-treated with yohimbine
10893789|NCT00535002|OG001|Outcome|Cocaine Females Placebo|Cocaine-dependent females pre-treated with placebo
10893790|NCT00535002|OG002|Outcome|Cocaine Males Yohimbine|Cocaine-dependent males pre-treated with yohimbine
10893791|NCT00535002|OG003|Outcome|Cocaine Males Placebo|Cocaine-dependent males pre-treated with placebo
10893792|NCT00535002|OG004|Outcome|Control Females Yohimbine|
10893793|NCT00535002|OG005|Outcome|Control Females Placebo|
10893794|NCT00535002|OG006|Outcome|Control Males Yohimbine|
10893795|NCT00535002|OG007|Outcome|Control Males Placebo|
10893796|NCT00535002|EG000|Reported Event|Cocaine Females|Cocaine-dependent females
10893797|NCT00535002|EG001|Reported Event|Cocaine Males|Cocaine-dependent males
10893798|NCT00535002|EG002|Reported Event|Control Females|Non-dependent females
10893799|NCT00535002|EG003|Reported Event|Control Males|Non-dependent males
10893800|NCT00535132|BG000|Baseline|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
10893801|NCT00535132|BG001|Baseline|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were then to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
10893802|NCT00535132|BG002|Baseline|Total|Total of all reporting groups
10893803|NCT00535132|FG000|Participant Flow|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
11171344|NCT02002650|OG000|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
10893804|NCT00535132|FG001|Participant Flow|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
10893805|NCT00535132|OG000|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
10893806|NCT00535132|OG001|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
10893807|NCT00535132|OG002|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
10893808|NCT00535132|EG000|Reported Event|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
10893809|NCT00535132|EG001|Reported Event|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
10893810|NCT00535132|EG002|Reported Event|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
10893811|NCT00535145|BG000|Baseline|Study Treatment|"Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to treatment as usual abbreviated as TAU) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)."
10893812|NCT00535145|FG000|Participant Flow|Study Treatment|"Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to treatment as usual abbreviated as TAU) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)"
10893813|NCT00535145|OG000|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
10893814|NCT00535145|OG000|Outcome|TAU Phase|Day 1 through Day 27 (4 weeks)
10893815|NCT00535145|OG001|Outcome|Paliperidone ER Phase|Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
10893816|NCT00535145|EG000|Reported Event|TAU - Pali ER|"Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to treatment as usual abbreviated as TAU) for 4 weeks who went on to participate in Phase 2 (Paliperidone ER Phase)."
10893817|NCT00535145|EG001|Reported Event|Paliperidone ER Phase|Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
10893818|NCT00535145|EG002|Reported Event|TAU - All Enrolled Participants|"Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to treatment as usual abbreviated as TAU) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)."
10893819|NCT00535223|BG000|Baseline|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
10893820|NCT00535223|BG001|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
10893821|NCT00535223|BG002|Baseline|Total|Total of all reporting groups
10893822|NCT00535223|FG000|Participant Flow|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
11357446|NCT03757312|OG000|Outcome|Fontan|"Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.~Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD)."
11090445|NCT01529112|FG000|Participant Flow|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
11090446|NCT01529112|FG001|Participant Flow|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
11090447|NCT01529112|OG000|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
11357447|NCT03757312|OG001|Outcome|Non-Fontan|Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
10893823|NCT00535223|FG001|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
10893824|NCT00535223|OG000|Outcome|Group Based Exposure Therapy|"See below~Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
10893825|NCT00535223|OG001|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
10893826|NCT00535223|EG000|Reported Event|Group Based Exposure Therapy|Group Based Exposure Therapy. No serious adverse events occurred in response to this treatment.
10893827|NCT00535223|EG001|Reported Event|Present Centered Group Therapy|Present Centered Group Therapy. No serious adverse events occurred in response to this treatment.
10893828|NCT00535236|BG000|Baseline|Autologous HCT-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893829|NCT00535236|BG001|Baseline|Autologous HCT-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893830|NCT00535236|BG002|Baseline|Allogeneic HCT-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893831|NCT00535236|BG003|Baseline|Allogeneic HCT-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893832|NCT00535236|BG004|Baseline|STM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893833|NCT00535236|BG005|Baseline|STM-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893834|NCT00535236|BG006|Baseline|HM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090448|NCT01529112|OG001|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
10893835|NCT00535236|BG007|Baseline|HM-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893836|NCT00535236|BG008|Baseline|HIV-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893837|NCT00535236|BG009|Baseline|HIV-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893838|NCT00535236|BG010|Baseline|Total|Total of all reporting groups
10893839|NCT00535236|FG000|Participant Flow|Autologous HCT-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893840|NCT00535236|FG001|Participant Flow|Autologous HCT-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893841|NCT00535236|FG002|Participant Flow|Allogeneic HCT-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893842|NCT00535236|FG003|Participant Flow|Allogeneic HCT-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893843|NCT00535236|FG004|Participant Flow|STM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893844|NCT00535236|FG005|Participant Flow|STM-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893845|NCT00535236|FG006|Participant Flow|HM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893846|NCT00535236|FG007|Participant Flow|HM-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893847|NCT00535236|FG008|Participant Flow|HIV-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893848|NCT00535236|FG009|Participant Flow|HIV-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893849|NCT00535236|OG000|Outcome|STM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
11090449|NCT01529112|EG000|Reported Event|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
10893850|NCT00535236|OG001|Outcome|HM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893851|NCT00535236|OG002|Outcome|HIV-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893852|NCT00535236|OG000|Outcome|Autologous HCT-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893853|NCT00535236|OG001|Outcome|Autologous HCT-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893854|NCT00535236|OG002|Outcome|Allogeneic HCT-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893855|NCT00535236|OG003|Outcome|Allogeneic HCT-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893856|NCT00535236|OG004|Outcome|STM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893857|NCT00535236|OG005|Outcome|STM-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893858|NCT00535236|OG006|Outcome|HM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893859|NCT00535236|OG007|Outcome|HM-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893860|NCT00535236|OG008|Outcome|HIV-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893861|NCT00535236|OG009|Outcome|HIV-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893862|NCT00535236|EG000|Reported Event|Autologous HCT-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893863|NCT00535236|EG001|Reported Event|Autologous HCT-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893864|NCT00535236|EG002|Reported Event|Allogeneic-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893865|NCT00535236|EG003|Reported Event|Allogeneic-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893866|NCT00535236|EG004|Reported Event|STM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893867|NCT00535236|EG005|Reported Event|STM-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893868|NCT00535236|EG006|Reported Event|HM-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893869|NCT00535236|EG007|Reported Event|HM-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893870|NCT00535236|EG008|Reported Event|HIV-V212|Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893871|NCT00535236|EG009|Reported Event|HIV-Placebo|Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
10893872|NCT00535288|BG000|Baseline|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
10893873|NCT00535288|BG001|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893874|NCT00535288|BG002|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893875|NCT00535288|BG003|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893876|NCT00535288|BG004|Baseline|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893877|NCT00535288|BG005|Baseline|Total|Total of all reporting groups
10893878|NCT00535288|FG000|Participant Flow|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
10893879|NCT00535288|FG001|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893880|NCT00535288|FG002|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893881|NCT00535288|FG003|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893882|NCT00535288|FG004|Participant Flow|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893883|NCT00535288|OG000|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
10893884|NCT00535288|OG001|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893885|NCT00535288|OG002|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893886|NCT00535288|OG003|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893887|NCT00535288|OG004|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
10893888|NCT00535288|OG000|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
10893889|NCT00535288|OG000|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
10893890|NCT00535288|OG004|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893891|NCT00535288|OG003|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
10893892|NCT00535288|OG004|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893893|NCT00535288|EG000|Reported Event|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
10893894|NCT00535288|EG001|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893895|NCT00535288|EG002|Reported Event|Esmertazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893896|NCT00535288|EG003|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893897|NCT00535288|EG004|Reported Event|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
10893898|NCT00535301|BG000|Baseline|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
10893899|NCT00535301|BG001|Baseline|Perigee|Anterior vaginal prolapse repair with graft
10893900|NCT00535301|BG002|Baseline|Total|Total of all reporting groups
10893901|NCT00535301|FG000|Participant Flow|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
10893902|NCT00535301|FG001|Participant Flow|Perigee|Anterior vaginal prolapse repair with graft
10893903|NCT00535301|OG000|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
10893904|NCT00535301|OG001|Outcome|Perigee|Anterior vaginal prolapse repair with graft
10893905|NCT00535301|OG000|Outcome|Anterior Colporrhaphy (Sutured Repair)|Sutured anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
10893906|NCT00535301|OG001|Outcome|Perigee (Grafted Repair)|Anterior vaginal prolapse repair with graft
10893907|NCT00535301|EG000|Reported Event|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
10893908|NCT00535301|EG001|Reported Event|Perigee|Anterior vaginal prolapse repair with graft
10893909|NCT00535392|BG000|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
10893910|NCT00535392|FG000|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
10893911|NCT00535392|OG000|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
10893912|NCT00535392|EG000|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
10893913|NCT00535496|BG000|Baseline|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
10893914|NCT00535496|BG001|Baseline|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
10893915|NCT00535496|BG002|Baseline|Total|Total of all reporting groups
10893916|NCT00535496|FG000|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The Train of Four (TOF)-Watch® SX was on the dominant forearm and the peripheral nerve stimulator (PNS) was on the non-dominant forearm.
10893917|NCT00535496|FG001|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
11357448|NCT03757312|OG000|Outcome|Short CPB Time|Short CPB time defined as <100 minutes.
10893918|NCT00535496|FG002|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the dominant forearm and the PNS was on the non-dominant forearm.
10893919|NCT00535496|FG003|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
10893920|NCT00535496|OG000|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
10893921|NCT00535496|OG000|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
10893922|NCT00535496|OG001|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
10893923|NCT00535496|EG000|Reported Event|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
10893924|NCT00535496|EG001|Reported Event|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
10893925|NCT00535587|BG000|Baseline|Mestinon & Exercise|
10893926|NCT00535587|BG001|Baseline|Mestinon and Attention Control|
10893927|NCT00535587|BG002|Baseline|Placebo Pill and Exercise|
10893928|NCT00535587|BG003|Baseline|Placebo Pill and Attention Control|
10893929|NCT00535587|BG004|Baseline|Total|Total of all reporting groups
10893930|NCT00535587|FG000|Participant Flow|Mestinon & Exercise|
10893931|NCT00535587|FG001|Participant Flow|Mestinon and Attention Control|
10893932|NCT00535587|FG002|Participant Flow|Placebo Pill and Exercise|
10893933|NCT00535587|FG003|Participant Flow|Placebo Pill and Attention Control|
10893934|NCT00535587|OG000|Outcome|Mestinon/Exercise|
10893935|NCT00535587|OG001|Outcome|Placebo Pill/Attention Control|
10893936|NCT00535587|EG000|Reported Event|Mestinon & Exercise|
10893937|NCT00535587|EG001|Reported Event|Mestinon and Attention Control|
10893938|NCT00535587|EG002|Reported Event|Placebo Pill and Exercise|
10893939|NCT00535587|EG003|Reported Event|Placebo Pill and Attention Control|
10893940|NCT00535613|BG000|Baseline|Propofol|Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg
10893941|NCT00535613|BG001|Baseline|Placebo|No propofol
10893942|NCT00535613|BG002|Baseline|Total|Total of all reporting groups
10893943|NCT00535613|FG000|Participant Flow|Propofol|Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg
10893944|NCT00535613|FG001|Participant Flow|Placebo|No propofol
10893945|NCT00535613|OG000|Outcome|Propofol|Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg
10893946|NCT00535613|OG001|Outcome|Placebo|No propofol
10893947|NCT00535613|EG000|Reported Event|Propofol|Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg
10893948|NCT00535613|EG001|Reported Event|Placebo|No propofol
10893949|NCT00535626|BG000|Baseline|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
10893950|NCT00535626|FG000|Participant Flow|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
10893951|NCT00535626|OG000|Outcome|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
10893952|NCT00535626|EG000|Reported Event|Operative Site Events|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Operative site events are reported by hip.
10893953|NCT00535626|EG001|Reported Event|Non-operative Site Events|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Non-Operative site events are reported by participant.
10893954|NCT00535652|BG000|Baseline|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
10893955|NCT00535652|FG000|Participant Flow|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
10893956|NCT00535652|OG000|Outcome|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
10893957|NCT00535652|EG000|Reported Event|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
10893958|NCT00535730|BG000|Baseline|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
10893959|NCT00535730|BG001|Baseline|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
10893960|NCT00535730|BG002|Baseline|Total|Total of all reporting groups
10893961|NCT00535730|FG000|Participant Flow|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
10893962|NCT00535730|FG001|Participant Flow|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
10893963|NCT00535730|OG000|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
10893964|NCT00535730|OG001|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
10893965|NCT00535730|OG000|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
10893966|NCT00535730|EG000|Reported Event|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
10893967|NCT00535730|EG001|Reported Event|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
10914769|NCT00632749|OG000|Outcome|Treatment Schedule A|"Subjects received BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).~BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).~The starting dose for BI 811283 was 5 mg, with dose levels of 5, 15, 30, 60, 100 and 120 mg used in Schedule A.~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914770|NCT00632749|OG001|Outcome|Treatment Schedule B|"Subjects received BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).~BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).~The starting dose for BI 811283 was 5 mg, with dose levels of 5, 40, 80, 160, 240, 300, 360 and 420 mg being used in Schedule B.~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914771|NCT00632749|OG000|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914772|NCT00632749|OG001|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11090450|NCT01529112|EG001|Reported Event|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
11090451|NCT01529203|BG000|Baseline|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
11090452|NCT01529203|FG000|Participant Flow|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
11171345|NCT02002650|OG001|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
10914773|NCT00632749|OG002|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914774|NCT00632749|OG003|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914775|NCT00632749|OG004|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914776|NCT00632749|OG005|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914777|NCT00632749|OG006|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914778|NCT00632749|OG007|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914779|NCT00632749|OG008|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914780|NCT00632749|OG009|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11233208|NCT02424799|FG001|Participant Flow|Part A-GSK2646264 1% and Placebo|Participants received active treatment (1% cream strength) and placebo on Days 1, 2, 3 and 4. On Day 1 and Day 2, participants received treatment to 0.2% BSA; active treatment on one arm and placebo on the other arm. In addition, participants received treatment to another 5% BSA; active to one side of the torso and placebo to the other. On Days 3 and 4, the same treatment to the arms was applied as on Days 1 and 2, but the %BSA of the torso to which treatment was applied to was increased to 10%.
11233209|NCT02424799|FG002|Participant Flow|Part B-Placebo|CU participants received matching placebo treatment to an area of 10% BSA (5% BSA on each arm, n=1) or 3.5% BSA (spread over the 2 arms, n=2) on Days 1, 2 and 3
11233210|NCT02424799|FG003|Participant Flow|Part B GSK2646264 1%|CU participants received 1% strength GSK2646264 to an area of 10% BSA (5% BSA on each arm, n=3) or 3% BSA (spread over the 2 arms, n=6) on Days 1, 2 and 3
10893968|NCT00535743|BG000|Baseline|Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®|Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
10893969|NCT00535743|BG001|Baseline|Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893970|NCT00535743|BG002|Baseline|Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893971|NCT00535743|BG003|Baseline|Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893972|NCT00535743|BG004|Baseline|Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893973|NCT00535743|BG005|Baseline|Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893974|NCT00535743|BG006|Baseline|Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®|Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893975|NCT00535743|BG007|Baseline|Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893976|NCT00535743|BG008|Baseline|Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
11233211|NCT02424799|FG004|Participant Flow|Part C-Placebo|CSU participants received matching placebo treatment to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
11233212|NCT02424799|FG005|Participant Flow|Part C GSK2646264 1%|CSU participants received 1% strength GSK2646264 to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
11233213|NCT02424799|OG000|Outcome|Part A-GSK2646264 0.5%|Participants were treated topically with 0.5 % GSK2646264 cream and placebo cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
11233214|NCT02424799|OG000|Outcome|Part A-GSK2646264 1%|Participants received active treatment (1% cream strength) on Days 1, 2, 3 and 4. On Day 1 and Day 2, participants received treatment to 0.2% BSA; active treatment on one arm. In addition, participants received treatment to another 5% BSA; active to one side of the torso. On Days 3 and 4, the same treatment to the arms was applied as on Days 1 and 2, but the %BSA of the torso to which treatment was applied to was increased to 10%.
11233215|NCT02424799|OG000|Outcome|Part B (10% BSA)-Placebo|CU participants received matching placebo treatment to an area of 10% BSA (5% BSA each arm) on Days 1, 2 and 3.
11233216|NCT02424799|OG001|Outcome|Part B (10% BSA) GSK2646264 1%|CU participants received 1% strength GSK2646264 treatment to an area of 10% BSA (5% BSA on each arm) on Days 1, 2 and 3.
11233217|NCT02424799|OG002|Outcome|Part B (3.5% BSA)-Placebo|CU participants received matching placebo treatment to an area of 3.5% BSA (spread over the 2 arms) on Days 1, 2 and 3.
10893977|NCT00535743|BG009|Baseline|Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893978|NCT00535743|BG010|Baseline|Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893979|NCT00535743|BG011|Baseline|Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893980|NCT00535743|BG012|Baseline|Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®|Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893981|NCT00535743|BG013|Baseline|Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893982|NCT00535743|BG014|Baseline|Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893983|NCT00535743|BG015|Baseline|Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893984|NCT00535743|BG016|Baseline|Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893985|NCT00535743|BG017|Baseline|Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893986|NCT00535743|BG018|Baseline|Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®|Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893987|NCT00535743|BG019|Baseline|Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893988|NCT00535743|BG020|Baseline|Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
11357449|NCT03757312|OG001|Outcome|Long CPB Time|Long CPB time defined as ≥ 100 minutes.
10893989|NCT00535743|BG021|Baseline|Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893990|NCT00535743|BG022|Baseline|Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893991|NCT00535743|BG023|Baseline|Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10893992|NCT00535743|BG024|Baseline|Total|Total of all reporting groups
10893993|NCT00535743|FG000|Participant Flow|Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®|Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
10893994|NCT00535743|FG001|Participant Flow|Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893995|NCT00535743|FG002|Participant Flow|Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893996|NCT00535743|FG003|Participant Flow|Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893997|NCT00535743|FG004|Participant Flow|Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893998|NCT00535743|FG005|Participant Flow|Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10893999|NCT00535743|FG006|Participant Flow|Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®|Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894000|NCT00535743|FG007|Participant Flow|Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894001|NCT00535743|FG008|Participant Flow|Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894002|NCT00535743|FG009|Participant Flow|Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894003|NCT00535743|FG010|Participant Flow|Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894004|NCT00535743|FG011|Participant Flow|Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894005|NCT00535743|FG012|Participant Flow|Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®|Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894006|NCT00535743|FG013|Participant Flow|Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894007|NCT00535743|FG014|Participant Flow|Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894008|NCT00535743|FG015|Participant Flow|Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894009|NCT00535743|FG016|Participant Flow|Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894010|NCT00535743|FG017|Participant Flow|Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894011|NCT00535743|FG018|Participant Flow|Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®|Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894012|NCT00535743|FG019|Participant Flow|Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894013|NCT00535743|FG020|Participant Flow|Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894014|NCT00535743|FG021|Participant Flow|Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894015|NCT00535743|FG022|Participant Flow|Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894016|NCT00535743|FG023|Participant Flow|Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894017|NCT00535743|OG000|Outcome|Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®|Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
10894018|NCT00535743|OG001|Outcome|Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894019|NCT00535743|OG002|Outcome|Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894020|NCT00535743|OG003|Outcome|Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894021|NCT00535743|OG004|Outcome|Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894022|NCT00535743|OG005|Outcome|Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894023|NCT00535743|OG006|Outcome|Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®|Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894024|NCT00535743|OG007|Outcome|Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894025|NCT00535743|OG008|Outcome|Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894026|NCT00535743|OG009|Outcome|Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894027|NCT00535743|OG010|Outcome|Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894028|NCT00535743|OG011|Outcome|Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894029|NCT00535743|OG012|Outcome|Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®|Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894030|NCT00535743|OG013|Outcome|Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894031|NCT00535743|OG014|Outcome|Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894032|NCT00535743|OG015|Outcome|Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894033|NCT00535743|OG016|Outcome|Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894034|NCT00535743|OG017|Outcome|Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894035|NCT00535743|OG018|Outcome|Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®|Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894036|NCT00535743|OG019|Outcome|Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894037|NCT00535743|OG020|Outcome|Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
11090453|NCT01529203|OG000|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
10894038|NCT00535743|OG021|Outcome|Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894039|NCT00535743|OG022|Outcome|Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894040|NCT00535743|OG023|Outcome|Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®|Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894041|NCT00535743|EG000|Reported Event|Arm A. Placebo; 3 Min After 1 mg/kg Esmeron|Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894042|NCT00535743|EG001|Reported Event|Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron|Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894043|NCT00535743|EG002|Reported Event|Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron|Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894044|NCT00535743|EG003|Reported Event|Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron|Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894045|NCT00535743|EG004|Reported Event|Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron|Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894046|NCT00535743|EG005|Reported Event|Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron|Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894047|NCT00535743|EG006|Reported Event|Arm G. Placebo; 15 Min After 1 mg/kg Esmeron|Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894048|NCT00535743|EG007|Reported Event|Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron|Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894049|NCT00535743|EG008|Reported Event|Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron|Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894050|NCT00535743|EG009|Reported Event|Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron|Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894051|NCT00535743|EG010|Reported Event|Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron|Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894052|NCT00535743|EG011|Reported Event|Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron|Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
10894053|NCT00535743|EG012|Reported Event|Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron|Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894054|NCT00535743|EG013|Reported Event|Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron|Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894055|NCT00535743|EG014|Reported Event|Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron|Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894056|NCT00535743|EG015|Reported Event|Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron|Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894057|NCT00535743|EG016|Reported Event|Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron|Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894058|NCT00535743|EG017|Reported Event|Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron|Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894059|NCT00535743|EG018|Reported Event|Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron|Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894060|NCT00535743|EG019|Reported Event|Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron|Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894061|NCT00535743|EG020|Reported Event|Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron|Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894062|NCT00535743|EG021|Reported Event|Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron|Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894063|NCT00535743|EG022|Reported Event|Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron|Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894064|NCT00535743|EG023|Reported Event|Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron|Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
10894065|NCT00535769|BG000|Baseline|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
10894066|NCT00535769|BG001|Baseline|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
10894067|NCT00535769|BG002|Baseline|Total|Total of all reporting groups
10894068|NCT00535769|FG000|Participant Flow|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
10894069|NCT00535769|FG001|Participant Flow|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
10894070|NCT00535769|OG000|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
10894071|NCT00535769|OG001|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
10894072|NCT00535769|OG000|Outcome|Usefulness of Text Messaging System|Patients with text reminder system were asked their opinion of the usefulness of message reminder from 0-10 (0, not useful at all; 10,most useful)
10894073|NCT00535769|EG000|Reported Event|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
10894074|NCT00535769|EG001|Reported Event|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
10894075|NCT00535782|BG000|Baseline|TCZ + MTX|During Part 1 of the study participants received 8 mg/kg tocilizumab (TCZ) by intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received open-label 8 mg/kg TCZ every 4 weeks plus 7.5-25 mg MTX weekly.
10894076|NCT00535782|BG001|Baseline|Placebo + MTX|During Part 1 of the study participants received placebo intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received 8 mg/kg TCZ IV every 4 weeks plus 7.5-25 mg MTX weekly.
10894077|NCT00535782|BG002|Baseline|Total|Total of all reporting groups
10894078|NCT00535782|FG000|Participant Flow|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
10894079|NCT00535782|FG001|Participant Flow|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
10894080|NCT00535782|FG002|Participant Flow|Part 2: TCZ + MTX|During Part 2 of the study, from Week 24 to Week 104, all participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
10894081|NCT00535782|OG000|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
10894082|NCT00535782|OG001|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
10894083|NCT00535782|EG000|Reported Event|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
10894084|NCT00535782|EG001|Reported Event|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
10894085|NCT00535782|EG002|Reported Event|All TCZ + MTX|Includes patients who received at least one dose of active tocilizumab (TCZ) regardless of when they received it during the study and whether it was double-blind (Part 1) or open-label (Part 2). Participants received 8 mg/kg TCZ by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
10894086|NCT00535821|BG000|Baseline|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
10894087|NCT00535821|BG001|Baseline|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
10894088|NCT00535821|BG002|Baseline|Total|Total of all reporting groups
10894089|NCT00535821|FG000|Participant Flow|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
10894090|NCT00535821|FG001|Participant Flow|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
10894091|NCT00535821|OG000|Outcome|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
10894092|NCT00535821|OG001|Outcome|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
10894093|NCT00535821|EG000|Reported Event|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
10894094|NCT00535821|EG001|Reported Event|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
10894095|NCT00535847|BG000|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
11090454|NCT01529203|EG000|Reported Event|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
10894096|NCT00535847|BG001|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10894097|NCT00535847|BG002|Baseline|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
10894098|NCT00535847|BG003|Baseline|Total|Total of all reporting groups
10894099|NCT00535847|FG000|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
10894100|NCT00535847|FG001|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
11090455|NCT01529268|BG000|Baseline|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
11233218|NCT02424799|OG003|Outcome|Part B (3.5% BSA) GSK2646264 1%|CU participants received 1% strength GSK2646264 treatment to an area of 3.5% BSA (spread over the 2 arms) on Days 1, 2 and 3.
10894101|NCT00535847|FG002|Participant Flow|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
10894102|NCT00535847|OG000|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
10894103|NCT00535847|OG001|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10894104|NCT00535847|OG002|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
10894105|NCT00535847|OG000|Outcome|Achieved eRVR/Achieved SVR|"All subjects in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week and Other reporting groups who achieved eRVR and SVR in this study (VX06-950-107 [NCT00535847])."
10894106|NCT00535847|OG001|Outcome|Achieved eRVR/Did Not Achieve SVR|"All subjects in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week and Other reporting groups who achieved eRVR but did not achieve SVR in this study (VX06-950-107 [NCT00535847])."
10894107|NCT00535847|OG002|Outcome|Did Not Achieve eRVR/Achieved SVR|"All subjects in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week and Other reporting groups who did not achieve eRVR but achieved SVR in this study (VX06-950-107 [NCT00535847])."
10894108|NCT00535847|OG003|Outcome|Did Not Achieve eRVR/Did Not Achieve SVR|"All subjects in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week and Other reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 [NCT00535847])."
11090456|NCT01529268|BG001|Baseline|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
10894109|NCT00535847|EG000|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
10894110|NCT00535847|EG001|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
10894111|NCT00535847|EG002|Reported Event|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
10894112|NCT00535873|BG000|Baseline|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
10894113|NCT00535873|FG000|Participant Flow|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
10894114|NCT00535873|OG000|Outcome|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
10894115|NCT00535873|EG000|Reported Event|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
10894116|NCT00535925|BG000|Baseline|Conventional Therapy|"Control group patients will continue their usual therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.~current therapy: the patients have to be treated according the standard good medical practice by any center"
11090457|NCT01529268|BG002|Baseline|Total|Total of all reporting groups
11090458|NCT01529268|FG000|Participant Flow|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
11090459|NCT01529268|FG001|Participant Flow|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
11233219|NCT02424799|OG000|Outcome|Part C-Placebo|CSU participants received matching placebo treatment to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
10914781|NCT00632749|OG010|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10894117|NCT00535925|BG001|Baseline|Intensified Therapy|"Intensive multifactorial intervention is performed to achieve goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia. New antihypertensive drugs will be added one by one until achievement of BP target (<130/80 mmHg).~Therapy for Hypertension~Step1 - irbesartan 300 mg/die and ramipril 10 mg/die~Step 2 (Diuretic) - hydrochlorothiazide 12.5-25 mg/die, if creatinine <2 mg/dL / furosemide 25-75 mg/die, if creatinine ≥2 mg/dL~Step 3 - amlodipine up to 10 mg/die~Step 4 - atenolol up to 100 mg/die~Step 5 - doxazosin up to 4 mg/die~Step 6 - Clonidine~Therapy for Hyperglycaemia (to achieve HbA1c <7): insulin~Therapy for hypercholesterolemia (to reduce LDL <100 mg/dl) --> simvastatin till 80 mg/die~Therapy for hypertriglyceridemia (to reduce triglycerides <150 mg/dl and/or increase HDL >40-50 mg/dl) --> fibrate~Treatment of anaemia: erythropoietin~Antiplatelets (all patients without contraindications): aspirin till 160 mg/die"
10894118|NCT00535925|BG002|Baseline|Total|Total of all reporting groups
10894119|NCT00535925|FG000|Participant Flow|Conventional Therapy|"Control group patients will continue their usual therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.~current therapy: the patients have to be treated according the standard good medical practice by any center"
10894120|NCT00535925|FG001|Participant Flow|Intensified Therapy|"Intensive multifactorial intervention is performed to achieve goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia. New antihypertensive drugs will be added one by one until achievement of BP target (<130/80 mmHg).~Therapy for Hypertension~Step1 - irbesartan 300 mg/die and ramipril 10 mg/die~Step 2 (Diuretic) - hydrochlorothiazide 12.5-25 mg/die, if creatinine <2 mg/dL / furosemide 25-75 mg/die, if creatinine ≥2 mg/dL~Step 3 - amlodipine up to 10 mg/die~Step 4 - atenolol up to 100 mg/die~Step 5 - doxazosin up to 4 mg/die~Step 6 - Clonidine~Therapy for Hyperglycaemia (to achieve HbA1c <7): insulin~Therapy for hypercholesterolemia (to reduce LDL <100 mg/dl) --> simvastatin till 80 mg/die~Therapy for hypertriglyceridemia (to reduce triglycerides <150 mg/dl and/or increase HDL >40-50 mg/dl) --> fibrate~Treatment of anaemia: erythropoietin~Antiplatelets (all patients without contraindications): aspirin till 160 mg/die"
10894121|NCT00535925|OG000|Outcome|Conventional Therapy|"Control group patients will continue their usual therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.~current therapy: the patients have to be treated according the standard good medical practice by any center"
10894122|NCT00535925|OG001|Outcome|Intensified Therapy|"Intensive multifactorial intervention is performed to achieve goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia. New antihypertensive drugs will be added one by one until achievement of BP target (<130/80 mmHg).~Therapy for Hypertension~Step1 - irbesartan 300 mg/die and ramipril 10 mg/die~Step 2 (Diuretic) - hydrochlorothiazide 12.5-25 mg/die, if creatinine <2 mg/dL / furosemide 25-75 mg/die, if creatinine ≥2 mg/dL~Step 3 - amlodipine up to 10 mg/die~Step 4 - atenolol up to 100 mg/die~Step 5 - doxazosin up to 4 mg/die~Step 6 - Clonidine~Therapy for Hyperglycaemia (to achieve HbA1c <7): insulin~Therapy for hypercholesterolemia (to reduce LDL <100 mg/dl) --> simvastatin till 80 mg/die~Therapy for hypertriglyceridemia (to reduce triglycerides <150 mg/dl and/or increase HDL >40-50 mg/dl) --> fibrate~Treatment of anaemia: erythropoietin~Antiplatelets (all patients without contraindications): aspirin till 160 mg/die"
10894123|NCT00535925|OG000|Outcome|Standard of Care (SoC) Therapy|"Control group patients will continue their SoC therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.~SoC therapy: the patients have to be treated according the standard good medical practice by any center"
10894124|NCT00535925|OG001|Outcome|Multifactorial Intensified Therapy|"An intensive multifactorial intervention according Scientific Guidelines is performed to achieve the goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia.~In particular, new antihypertensive drugs will be added one by one until the achievement of blood pressure target (<130/80 mmHg).~Therapy for hypertension:~step 1: irbesartan 300 mg/die and ramipril 10 mg/die Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl) Step 3: amlodipine up to 10 mg/die"
11090460|NCT01529268|OG000|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
10894125|NCT00535925|EG000|Reported Event|Conventional Therapy|"Control group patients will continue their usual therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.~current therapy: the patients have to be treated according the standard good medical practice by any center"
10894126|NCT00535925|EG001|Reported Event|Intensified Therapy|"Intensive multifactorial intervention is performed to achieve goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia. New antihypertensive drugs will be added one by one until achievement of BP target (<130/80 mmHg).~Therapy for Hypertension~Step1 - irbesartan 300 mg/die and ramipril 10 mg/die~Step 2 (Diuretic) - hydrochlorothiazide 12.5-25 mg/die, if creatinine <2 mg/dL / furosemide 25-75 mg/die, if creatinine ≥2 mg/dL~Step 3 - amlodipine up to 10 mg/die~Step 4 - atenolol up to 100 mg/die~Step 5 - doxazosin up to 4 mg/die~Step 6 - Clonidine~Therapy for Hyperglycaemia (to achieve HbA1c <7): insulin~Therapy for hypercholesterolemia (to reduce LDL <100 mg/dl) --> simvastatin till 80 mg/die~Therapy for hypertriglyceridemia (to reduce triglycerides <150 mg/dl and/or increase HDL >40-50 mg/dl) --> fibrate~Treatment of anaemia: erythropoietin~Antiplatelets (all patients without contraindications): aspirin till 160 mg/die"
11090461|NCT01529268|OG001|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
11090462|NCT01529268|EG000|Reported Event|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
11233220|NCT02424799|OG001|Outcome|Part C GSK2646264 1%|CSU participants received 1% strength GSK2646264 to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
10894127|NCT00535938|BG000|Baseline|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
10894128|NCT00535938|BG001|Baseline|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
10894129|NCT00535938|BG002|Baseline|Total|Total of all reporting groups
10894130|NCT00535938|FG000|Participant Flow|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
10894131|NCT00535938|FG001|Participant Flow|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
10894132|NCT00535938|OG000|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
10894133|NCT00535938|OG001|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
10894134|NCT00535938|EG000|Reported Event|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
10894135|NCT00535938|EG001|Reported Event|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
10894136|NCT00536107|BG000|Baseline|Gefitinib|gefitinib 250mg
10894137|NCT00536107|BG001|Baseline|Docetaxel|docetaxel 60mg/m sq
10894138|NCT00536107|BG002|Baseline|Total|Total of all reporting groups
10894139|NCT00536107|FG000|Participant Flow|Gefitinib|gefitinib 250mg
10894140|NCT00536107|FG001|Participant Flow|Docetaxel|docetaxel 60mg/m sq
10894141|NCT00536107|OG000|Outcome|Gefitinib|gefitinib 250mg
10894142|NCT00536107|OG001|Outcome|Docetaxel|docetaxel 60mg/m sq
10894143|NCT00536107|EG000|Reported Event|Gefitinib|gefitinib 250mg
10894144|NCT00536107|EG001|Reported Event|Docetaxel|docetaxel 60mg/m sq
10894145|NCT00536120|BG000|Baseline|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
10894146|NCT00536120|BG001|Baseline|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
10894147|NCT00536120|BG002|Baseline|Total|Total of all reporting groups
10894148|NCT00536120|FG000|Participant Flow|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
10894149|NCT00536120|FG001|Participant Flow|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
10894150|NCT00536120|OG000|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
10894151|NCT00536120|OG001|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
10894152|NCT00536120|EG000|Reported Event|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at specified timepoints following the 7th dose.
10894153|NCT00536120|EG001|Reported Event|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at specified timepoints. They did not receive any treatment for their MS.
10894154|NCT00536172|BG000|Baseline|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
10894155|NCT00536172|BG001|Baseline|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
10894156|NCT00536172|BG002|Baseline|Total|Total of all reporting groups
10894157|NCT00536172|FG000|Participant Flow|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
10894158|NCT00536172|FG001|Participant Flow|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
10894159|NCT00536172|OG000|Outcome|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
10894160|NCT00536172|OG001|Outcome|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
10894161|NCT00536172|EG000|Reported Event|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
10894162|NCT00536172|EG001|Reported Event|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
10894163|NCT00536198|BG000|Baseline|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
11171346|NCT02002650|OG001|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin for high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just for high-risk patients."
10894164|NCT00536198|BG001|Baseline|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
10894165|NCT00536198|BG002|Baseline|Total|Total of all reporting groups
10894166|NCT00536198|FG000|Participant Flow|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
10894167|NCT00536198|FG001|Participant Flow|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
10894168|NCT00536198|OG000|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
10894169|NCT00536198|OG001|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
10894170|NCT00536198|OG000|Outcome|Sertraline|Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
10894171|NCT00536198|OG001|Outcome|Placebo|Participants will take similarly looking placebo during the symptomatic period Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
10894172|NCT00536198|EG000|Reported Event|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
10894173|NCT00536198|EG001|Reported Event|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
10894174|NCT00536263|BG000|Baseline|PEG 1.0 mcg/kg QW * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
10894175|NCT00536263|BG001|Baseline|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
10894176|NCT00536263|BG002|Baseline|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up; treated participants.
10894177|NCT00536263|BG003|Baseline|Total|Total of all reporting groups
10894178|NCT00536263|FG000|Participant Flow|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
10894179|NCT00536263|FG001|Participant Flow|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
10894180|NCT00536263|FG002|Participant Flow|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
11090463|NCT01529268|EG001|Reported Event|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
11090464|NCT01529346|BG000|Baseline|PF-05089771 150 mg|Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter [mm] on a 100 mm Visual Analog Scale [VAS] pain severity rating scale).
10894181|NCT00536263|OG000|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
10894182|NCT00536263|OG001|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
10894183|NCT00536263|OG002|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
10894184|NCT00536263|EG000|Reported Event|PEG 1.0 mcg/kg QW x24 Weeks|
10894185|NCT00536263|EG001|Reported Event|PEG 1.5 mcg/kg QW x24 Weeks|
10894186|NCT00536263|EG002|Reported Event|PEG 1.5 mcg/kg QW x48 Weeks|
10894187|NCT00536341|BG000|Baseline|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
10894188|NCT00536341|BG001|Baseline|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
10894189|NCT00536341|BG002|Baseline|Total|Total of all reporting groups
10894190|NCT00536341|FG000|Participant Flow|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
10894191|NCT00536341|FG001|Participant Flow|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
10894192|NCT00536341|OG000|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
10894193|NCT00536341|OG001|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
10894194|NCT00536341|OG000|Outcome|All Patients|
10894195|NCT00536341|EG000|Reported Event|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
10894196|NCT00536341|EG001|Reported Event|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
10894197|NCT00536471|BG000|Baseline|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
10894198|NCT00536471|BG001|Baseline|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
10894199|NCT00536471|BG002|Baseline|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
10894200|NCT00536471|BG003|Baseline|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
10894201|NCT00536471|BG004|Baseline|Total|Total of all reporting groups
10894202|NCT00536471|FG000|Participant Flow|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
10894203|NCT00536471|FG001|Participant Flow|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
10894204|NCT00536471|FG002|Participant Flow|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
10894205|NCT00536471|FG003|Participant Flow|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
10894206|NCT00536471|OG000|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
11171347|NCT02002650|EG000|Reported Event|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
10894207|NCT00536471|OG001|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
10894208|NCT00536471|OG002|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
10894209|NCT00536471|OG003|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
10894210|NCT00536471|OG000|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
10894211|NCT00536471|OG001|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
10894212|NCT00536471|OG002|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
10894213|NCT00536471|OG003|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
10894214|NCT00536471|OG000|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
10894215|NCT00536471|OG000|Outcome|Duloxetine (Not Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants remained on duloxetine 60 mg QD, PO for 6 months.
10894216|NCT00536471|OG001|Outcome|Duloxetine (Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants were increased to duloxetine 120 mg QD, PO for 6 months
10894217|NCT00536471|OG002|Outcome|Placebo (Not Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
11171348|NCT02002650|EG001|Reported Event|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
10894218|NCT00536471|OG003|Outcome|Placebo (Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
10894219|NCT00536471|EG000|Reported Event|Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
10894220|NCT00536471|EG001|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
10894221|NCT00536484|BG000|Baseline|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
10894222|NCT00536484|BG001|Baseline|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
10894223|NCT00536484|BG002|Baseline|Total|Total of all reporting groups
10894224|NCT00536484|FG000|Participant Flow|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
10894225|NCT00536484|FG001|Participant Flow|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
10894226|NCT00536484|OG000|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
10894227|NCT00536484|OG001|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
10894228|NCT00536484|EG000|Reported Event|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
10894229|NCT00536484|EG001|Reported Event|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
10894230|NCT00536510|BG000|Baseline|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
10894231|NCT00536510|BG001|Baseline|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
10894232|NCT00536510|BG002|Baseline|Total|Total of all reporting groups
10894233|NCT00536510|FG000|Participant Flow|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
10894234|NCT00536510|FG001|Participant Flow|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
11171349|NCT02002689|BG000|Baseline|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
10894235|NCT00536510|OG000|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
10894236|NCT00536510|OG001|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
10894237|NCT00536510|EG000|Reported Event|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
10894238|NCT00536510|EG001|Reported Event|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
10894239|NCT00536575|BG000|Baseline|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
10894240|NCT00536575|FG000|Participant Flow|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
10894241|NCT00536575|OG000|Outcome|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
10894242|NCT00536575|EG000|Reported Event|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
10894243|NCT00536601|BG000|Baseline|Acute Leukemia|Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
10894244|NCT00536601|BG001|Baseline|Hodgkin Lymphoma|Patients diagnosed with and treated for Hodgkin Lymphoma
10894245|NCT00536601|BG002|Baseline|Non-Hodgkin Lymphoma|Patients diagnosed with and treated for Non-Hodgkin Lymphoma
10894246|NCT00536601|BG003|Baseline|MM/Amyloid|Patients diagnosed with or treated for multiple myeloma or amyloidosis
10894247|NCT00536601|BG004|Baseline|Solid Tumors|Patients diagnosed with and treated for a solid tumor
10894248|NCT00536601|BG005|Baseline|Total|Total of all reporting groups
10894249|NCT00536601|FG000|Participant Flow|Acute Leukemia|Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
11171350|NCT02002689|FG000|Participant Flow|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
10894250|NCT00536601|FG001|Participant Flow|Hodgkin Lymphoma|Patients diagnosed with and treated for Hodgkin Lymphoma
10894251|NCT00536601|FG002|Participant Flow|Non-Hodgkin Lymphoma|Patients diagnosed with and treated for Non-Hodgkin Lymphoma
10894252|NCT00536601|FG003|Participant Flow|MM/Amyloid|Patients diagnosed with or treated for multiple myeloma or amyloidosis
10894253|NCT00536601|FG004|Participant Flow|Solid Tumors|Patients diagnosed with and treated for a solid tumor
10894254|NCT00536601|OG000|Outcome|Acute Leukemia|Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
10894255|NCT00536601|OG001|Outcome|Hodgkin Lymphoma|Patients diagnosed with and treated for Hodgkin Lymphoma
10894256|NCT00536601|OG002|Outcome|Non-Hodgkin Lymphoma|Patients diagnosed with and treated for Non-Hodgkin Lymphoma
10894257|NCT00536601|OG003|Outcome|MM/Amyloid|Patients diagnosed with or treated for multiple myeloma or amyloidosis
10894258|NCT00536601|OG004|Outcome|Solid Tumors|Patients diagnosed with and treated for a solid tumor
10894259|NCT00536601|EG000|Reported Event|Acute Leukemia|Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
10894260|NCT00536601|EG001|Reported Event|Hodgkin Lymphoma|Patients diagnosed with and treated for Hodgkin Lymphoma
10894261|NCT00536601|EG002|Reported Event|Non-Hodgkin Lymphoma|Patients diagnosed with and treated for Non-Hodgkin Lymphoma
10894262|NCT00536601|EG003|Reported Event|MM/Amyloid|Patients diagnosed with or treated for multiple myeloma or amyloidosis
10894263|NCT00536601|EG004|Reported Event|Solid Tumors|Patients diagnosed with and treated for a solid tumor
10894264|NCT00536731|BG000|Baseline|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
10894265|NCT00536731|BG001|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
10894266|NCT00536731|BG002|Baseline|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
10894267|NCT00536731|BG003|Baseline|Total|Total of all reporting groups
10894268|NCT00536731|FG000|Participant Flow|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
10894269|NCT00536731|FG001|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
10894270|NCT00536731|FG002|Participant Flow|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
10894271|NCT00536731|OG000|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
10894272|NCT00536731|OG001|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
10894273|NCT00536731|OG002|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
10894274|NCT00536731|EG000|Reported Event|Symbicort pMDI|Symbicort pMDI
10894275|NCT00536731|EG001|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler
10894276|NCT00536731|EG002|Reported Event|Pulmicort Turbuhaler|Pulmicort Turbuhaler
10894277|NCT00536744|BG000|Baseline|dermaPACE Application + Standard of Care|dermaPACE: dermaPACE + Standard of care wound dressing.
10894278|NCT00536744|BG001|Baseline|Non-energized (Inactive) Application + Standard of Care|Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.
10894279|NCT00536744|BG002|Baseline|Total|Total of all reporting groups
10894280|NCT00536744|FG000|Participant Flow|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
10894281|NCT00536744|FG001|Participant Flow|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
11171351|NCT02002689|OG000|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
10894282|NCT00536744|OG000|Outcome|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
10894283|NCT00536744|OG001|Outcome|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
10894284|NCT00536744|EG000|Reported Event|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
10894285|NCT00536744|EG001|Reported Event|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
10894286|NCT00536809|BG000|Baseline|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle
10894287|NCT00536809|FG000|Participant Flow|Lapatinib/Oxaliplatin/Capecitabine|Phase I: Dose escalation to a maximum tolerated dose of lapatinib 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle. Phase II: Lapatinib 1000 mg/day administered orally on Days 1-21, oxaliplatin 130 mg/m^2 administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle.
10894288|NCT00536809|OG000|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
10894289|NCT00536809|EG000|Reported Event|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
10894290|NCT00536874|BG000|Baseline|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
10894291|NCT00536874|FG000|Participant Flow|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
10894292|NCT00536874|OG000|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
10894293|NCT00536874|EG000|Reported Event|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
10894294|NCT00536913|BG000|Baseline|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
10894295|NCT00536913|BG001|Baseline|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
10894296|NCT00536913|BG002|Baseline|Total|Total of all reporting groups
10894297|NCT00536913|FG000|Participant Flow|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
10894298|NCT00536913|FG001|Participant Flow|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
10894299|NCT00536913|OG000|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
10894300|NCT00536913|OG001|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
10894301|NCT00536913|EG000|Reported Event|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
10894302|NCT00536913|EG001|Reported Event|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
10894303|NCT00536939|BG000|Baseline|Enzastaurin + Bevacizumab + Paclitaxel|"Safety Lead-in Period: Enzastaurin 1125 milligrams (mg) loading dose (total nine 125-mg tablets: 3 tablets, 3 times daily) administered orally, only on Day 1 of Cycle 1, followed by 500 mg (four 125-mg tablets) administered orally, once daily in a 28-day cycle plus bevacizumab 10 milligrams per kilogram (mg/kg) administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of every 28-day cycle. Participants were to receive enzastaurin, bevacizumab and paclitaxel for 2 cycles (1 cycle = 28 days).~Randomization Period: Participants were to receive the same treatment as administered during the safety lead-in period. Treatment was to continue until there was evidence of disease progression or intolerable toxicity."
10894304|NCT00536939|FG000|Participant Flow|Enzastaurin + Bevacizumab + Paclitaxel|"Safety Lead-in Period: Enzastaurin 1125 milligrams (mg) loading dose (total nine 125-mg tablets: 3 tablets, 3 times daily) administered orally, only on Day 1 of Cycle 1, followed by 500 mg (four 125-mg tablets) administered orally, once daily in a 28-day cycle plus bevacizumab 10 milligrams per kilogram (mg/kg) administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of every 28-day cycle. Participants were to receive enzastaurin, bevacizumab and paclitaxel for 2 cycles (1 cycle = 28 days).~Randomization Period: Participants were to receive the same treatment as administered during the safety lead-in period. Treatment was to continue until there was evidence of disease progression or intolerable toxicity."
11171352|NCT02002689|EG000|Reported Event|LDE225|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
10894305|NCT00536939|FG001|Participant Flow|Bevacizumab + Paclitaxel + Placebo|"Safety lead-in Period: No treatment~Randomization Period: Participants were to receive bevacizumab 10 mg/kg administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 mg/m^2 administered intravenously on Days 1, 8 and 15 of every 28-day cycle plus placebo loading dose administered orally (total 9 tablets: 3 tablets, 3 times daily) only on Day 1 of Cycle 1, followed by oral administration once daily in a 28-day cycle. Treatment was to continue until there was disease progression or intolerable toxicity."
10894306|NCT00536939|OG000|Outcome|Enzastaurin + Bevacizumab + Paclitaxel|"Safety Lead-in Period: Enzastaurin 1125 milligrams (mg) loading dose (total nine 125-mg tablets: 3 tablets, 3 times daily) administered orally, only on Day 1 of Cycle 1, followed by 500 mg (four 125-mg tablets) administered orally, once daily in a 28-day cycle plus bevacizumab 10 milligrams per kilogram (mg/kg) administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of every 28-day cycle. Participants were to receive enzastaurin, bevacizumab and paclitaxel for 2 cycles (1 cycle = 28 days).~Randomization Period: Participants were to receive the same treatment as administered during the safety lead-in period. Treatment was to continue until there was evidence of disease progression or intolerable toxicity."
10894307|NCT00536939|OG000|Outcome|Enzastaurin + Paclitaxel + Bevacizumab|"Safety Lead-in Period: Enzastaurin 1125 milligrams (mg) loading dose (total nine 125-mg tablets: 3 tablets, 3 times daily) administered orally, only on Day 1 of Cycle 1, followed by 500 mg (four 125-mg tablets) administered orally, once daily in a 28-day cycle plus bevacizumab 10 milligrams per kilogram (mg/kg) administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of every 28-day cycle. Participants were to receive enzastaurin, bevacizumab and paclitaxel for 2 cycles (1 cycle = 28 days).~Randomization Period: Participants were to receive the same treatment as administered during the safety lead-in period. Treatment was to continue until there was evidence of disease progression or intolerable toxicity."
10894308|NCT00536939|EG000|Reported Event|Enzastaurin + Bevacizumab + Paclitaxel|"Safety Lead-in Period: Enzastaurin 1125 milligrams (mg) loading dose (total nine 125-mg tablets: 3 tablets, 3 times daily) administered orally, only on Day 1 of Cycle 1, followed by 500 mg (four 125-mg tablets) administered orally, once daily in a 28-day cycle plus bevacizumab 10 milligrams per kilogram (mg/kg) administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of every 28-day cycle. Participants were to receive enzastaurin, bevacizumab and paclitaxel for 2 cycles (1 cycle = 28 days).~Randomization Period: Participants were to receive the same treatment as administered during the safety lead-in period. Treatment was to continue until there was evidence of disease progression or intolerable toxicity."
10894309|NCT00536991|BG000|Baseline|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
10894310|NCT00536991|FG000|Participant Flow|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
10894311|NCT00536991|OG000|Outcome|Treatment (Calcitriol, Ketoconazole, Hydrocortisone)|"PHASE I: Patients receive calcitriol PO QD on days 1-3, 8-10, 15-17, and 22-24. Patients also receive ketoconazole PO TID on days 1-24 and therapeutic hydrocortisone PO BID on days -1 to 24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive calcitriol and therapeutic hydrocortisone as in phase I. Patients also receive ketoconazole PO TID on days 4-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Calcitriol: Given PO~Ketoconazole: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Therapeutic Hydrocortisone: Given PO"
10894312|NCT00536991|OG000|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
10894313|NCT00536991|EG000|Reported Event|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
10894314|NCT00537017|BG000|Baseline|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
10894315|NCT00537017|FG000|Participant Flow|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
10894316|NCT00537017|OG000|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
10894317|NCT00537017|EG000|Reported Event|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
10894318|NCT00537030|BG000|Baseline|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
10894319|NCT00537030|FG000|Participant Flow|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
11171353|NCT02002702|BG000|Baseline|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
10894320|NCT00537030|OG000|Outcome|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
10894321|NCT00537030|EG000|Reported Event|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
10894322|NCT00537056|BG000|Baseline|F-18 FDG PET/CT and DCE MRI|"FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po~FDG PET CT: nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body~DCE MRI: DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).~F-18 Fluoro-deoxi-glucose: 15 mCi iv~Gadolinium-DTPA: 0.1 mmol/kg iv~Sunitinib: 50 mg/day po"
10894323|NCT00537056|FG000|Participant Flow|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
10894324|NCT00537056|OG000|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan
10894325|NCT00537056|OG000|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
10894326|NCT00537056|OG000|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
10894327|NCT00537056|EG000|Reported Event|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
10894328|NCT00537082|BG000|Baseline|FTY720 1.25 mg|Administered orally once daily for 6 months
10894329|NCT00537082|BG001|Baseline|FTY720 0.5 mg|Administered orally once daily for 6 months
10894330|NCT00537082|BG002|Baseline|Placebo|Administered orally once daily for 6 months
10894331|NCT00537082|BG003|Baseline|Total|Total of all reporting groups
10894332|NCT00537082|FG000|Participant Flow|FTY720 1.25 mg|Administered orally once daily for 6 months
10894333|NCT00537082|FG001|Participant Flow|FTY720 0.5 mg|Administered orally once daily for 6 months
10894334|NCT00537082|FG002|Participant Flow|Placebo|Administered orally once daily for 6 months
10894335|NCT00537082|OG000|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
10894336|NCT00537082|OG001|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
10894337|NCT00537082|OG002|Outcome|Placebo|Administered orally once daily for 6 months
10894338|NCT00537082|EG000|Reported Event|FTY720 1.25mg|Administered orally once daily for 6 months
10894339|NCT00537082|EG001|Reported Event|FTY720 0.5mg|Administered orally once daily for 6 months
10894340|NCT00537082|EG002|Reported Event|Placebo|Administered orally once daily for 6 months
10894341|NCT00537095|BG000|Baseline|ZD6474|ZD6474, Vandetanib 300mg
10894342|NCT00537095|BG001|Baseline|PLACEBO|PLACEBO
10894343|NCT00537095|BG002|Baseline|Total|Total of all reporting groups
10894344|NCT00537095|FG000|Participant Flow|ZD6474|ZD6474, Vandetanib 300mg
10894345|NCT00537095|FG001|Participant Flow|PLACEBO|PLACEBO
10894346|NCT00537095|OG000|Outcome|ZD6474|ZD6474, Vandetanib 300mg
10894347|NCT00537095|OG001|Outcome|PLACEBO|PLACEBO
10894348|NCT00537095|EG000|Reported Event|ZD6474|ZD6474, Vandetanib 300mg
10894349|NCT00537095|EG001|Reported Event|PLACEBO|PLACEBO
10894350|NCT00537238|BG000|Baseline|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
10894351|NCT00537238|BG001|Baseline|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
10894352|NCT00537238|BG002|Baseline|Total|Total of all reporting groups
10914782|NCT00632749|OG011|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11171354|NCT02002702|BG001|Baseline|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
11171355|NCT02002702|BG002|Baseline|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
10894353|NCT00537238|FG000|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily (BID) for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the titration phase (TP). If seizure control was inadequate (adequate: at least [>=] 50% reduction in seizures), pregabalin dose was escalated to 225 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week maintenance phase(MP). Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during TP and MP. After MP, participants were allowed to progress into optional (opt) blinded continuation phase, and remained on dose from MP for a maximum of 2 years or until last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
10894354|NCT00537238|FG001|Participant Flow|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
10894355|NCT00537238|OG000|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
10894356|NCT00537238|OG001|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
10894357|NCT00537238|EG000|Reported Event|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
10894358|NCT00537238|EG001|Reported Event|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
10894359|NCT00537277|BG000|Baseline|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
10894360|NCT00537277|FG000|Participant Flow|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
11171356|NCT02002702|BG003|Baseline|Total|Total of all reporting groups
10894361|NCT00537277|OG000|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
10894362|NCT00537277|EG000|Reported Event|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
10894363|NCT00537290|BG000|Baseline|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
10894364|NCT00537290|FG000|Participant Flow|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
10894365|NCT00537290|OG000|Outcome|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
10894366|NCT00537290|EG000|Reported Event|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
10894367|NCT00537303|BG000|Baseline|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
10894368|NCT00537303|BG001|Baseline|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
10894369|NCT00537303|BG002|Baseline|Total|Total of all reporting groups
10894370|NCT00537303|FG000|Participant Flow|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
10894371|NCT00537303|FG001|Participant Flow|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
11171357|NCT02002702|FG000|Participant Flow|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
10894372|NCT00537303|OG000|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
10894373|NCT00537303|OG001|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
10894374|NCT00537303|EG000|Reported Event|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
10894375|NCT00537303|EG001|Reported Event|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
10894376|NCT00537316|BG000|Baseline|Infliximab (IFX)|All treated participants. IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
10894377|NCT00537316|BG001|Baseline|Azathioprine (AZA)|All treated participants. AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
11171358|NCT02002702|FG001|Participant Flow|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
11171359|NCT02002702|FG002|Participant Flow|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
10894378|NCT00537316|BG002|Baseline|IFX/AZA|"All treated participants. IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
10894379|NCT00537316|BG003|Baseline|Maintenance IFX/AZA (During Part 2)|Participants enrolled directly and randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
10894380|NCT00537316|BG004|Baseline|Intermittent IFX/AZA (During Part 2)|Participants enrolled directly and randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
10894381|NCT00537316|BG005|Baseline|Intermittent IFX (During Part 2)|Participants enrolled directly and randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA daily in Part 2 of the study (1 participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
10894382|NCT00537316|BG006|Baseline|Total|Total of all reporting groups
10894383|NCT00537316|FG000|Participant Flow|Infliximab (IFX)|IFX 5 mg/kg Intravenous (IV) infusions administered at Weeks 0, 2, and 6 and placebo to AZA (orally) daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
10894384|NCT00537316|FG001|Participant Flow|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one placebo IFX infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive IFX at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
10894385|NCT00537316|FG002|Participant Flow|IFX/AZA|"IFX 5 mg/kg IV infusion at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more IFX infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
10894386|NCT00537316|FG003|Participant Flow|Maintenance IFX/AZA (During Part 2)|Participants randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
10894387|NCT00537316|FG004|Participant Flow|Maintenance IFX (During Part 2)|Participants randomized to maintenance IFX received infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) and placebo to AZA therapy as allocated in Part 1 of the study (all participants were from Part 1 of the study).
10894388|NCT00537316|FG005|Participant Flow|Intermittent IFX/AZA (During Part 2)|Participants randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
10894389|NCT00537316|FG006|Participant Flow|Intermittent IFX (During Part 2)|Participants randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA as allocated in Part 1 of the study (1 participant from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
10894390|NCT00537316|OG000|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
10894391|NCT00537316|OG001|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
10894392|NCT00537316|OG002|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
10894393|NCT00537316|EG000|Reported Event|AZA Through Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
10894394|NCT00537316|EG001|Reported Event|IFX/AZA Through Week 8|"Participants received intravenous (IV) infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
10894395|NCT00537316|EG002|Reported Event|IFX Through Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
11171360|NCT02002702|OG000|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
11171361|NCT02002702|OG001|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
10894396|NCT00537316|EG003|Reported Event|AZA After Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
10894397|NCT00537316|EG004|Reported Event|AZA to IFX/AZA After Week 8|Participants received AZA 2.5 mg/kg orally for 16 weeks and had IV infusions of IFX 5mg/kg of body weight added to their treatment regimen at Weeks 8, 10, and 14. Participants were either non-responders to AZA at Week 8 or had worsening of disease at Week 8.
10894398|NCT00537316|EG005|Reported Event|IFX/AZA After Week 8|"Participants received IV infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
10894399|NCT00537316|EG006|Reported Event|IFX After Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
10894400|NCT00537316|EG007|Reported Event|Maintenance IFX/AZA (Part 2)|Participants randomized to maintenance IFX/AZA during Part 2 received IV infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily. Four participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
10894401|NCT00537316|EG008|Reported Event|Maintenance IFX (Part 2)|Participants randomized to maintenance IFX received IV infusions of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry). All participants were from Part 1 of the study.
10894402|NCT00537316|EG009|Reported Event|Intermittent IFX/AZA (Part 2)|Participants randomized to intermittent IFX/AZA received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily. Three participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
10894403|NCT00537316|EG010|Reported Event|Intermittent IFX (Part 2)|Participants randomized to intermittent IFX received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained). One participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
10894404|NCT00537316|EG011|Reported Event|AZA (Part 2)|Participants received AZA 2.5 mg/kg of body weight orally daily for Part 2 of the study. All participants were from Part 1 of the study.
10894405|NCT00537316|EG012|Reported Event|IFX/AZA (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight every 8 weeks and AZA 2.5 mg/kg of body weight orally daily until the end of the study. All participants were from Part 1 of the study.
10894406|NCT00537316|EG013|Reported Event|IFX (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight until the end of the study. All participants were from Part 1 of the study.
10894407|NCT00537329|BG000|Baseline|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
10894408|NCT00537329|FG000|Participant Flow|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
10894409|NCT00537329|OG000|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
10894410|NCT00537329|EG000|Reported Event|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
10894411|NCT00537381|BG000|Baseline|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
10894412|NCT00537381|BG001|Baseline|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
10894413|NCT00537381|BG002|Baseline|Total|Total of all reporting groups
10894414|NCT00537381|FG000|Participant Flow|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
10894415|NCT00537381|FG001|Participant Flow|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
10894416|NCT00537381|OG000|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
10894417|NCT00537381|OG001|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
10894418|NCT00537381|EG000|Reported Event|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
10894419|NCT00537381|EG001|Reported Event|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
10894420|NCT00537381|EG002|Reported Event|Docetaxel + Prednisone + Placebo/ Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to intetumumab alone (2 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks till disease progression.
10894421|NCT00537381|EG003|Reported Event|Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to Docetaxel (D) + Prednisone (P) + intetumumab (9 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily till disease progression.
10894422|NCT00537394|BG000|Baseline|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
10894423|NCT00537394|BG001|Baseline|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
10894424|NCT00537394|BG002|Baseline|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
10894425|NCT00537394|BG003|Baseline|Total|Total of all reporting groups
10894426|NCT00537394|FG000|Participant Flow|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|[Arm A]Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
10894427|NCT00537394|FG001|Participant Flow|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|[Arm B] Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
10894428|NCT00537394|FG002|Participant Flow|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|[Non-randomized Group C] : Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
10894429|NCT00537394|OG000|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
11171362|NCT02002702|OG002|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
10894430|NCT00537394|OG001|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
10894431|NCT00537394|EG000|Reported Event|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
10894432|NCT00537394|EG001|Reported Event|Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
10894433|NCT00537407|BG000|Baseline|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
11171363|NCT02002702|EG000|Reported Event|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
10894434|NCT00537407|BG001|Baseline|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894435|NCT00537407|BG002|Baseline|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894436|NCT00537407|BG003|Baseline|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894437|NCT00537407|BG004|Baseline|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894438|NCT00537407|BG005|Baseline|Total|Total of all reporting groups
10894439|NCT00537407|FG000|Participant Flow|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894440|NCT00537407|FG001|Participant Flow|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894441|NCT00537407|FG002|Participant Flow|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894442|NCT00537407|FG003|Participant Flow|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894443|NCT00537407|FG004|Participant Flow|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894444|NCT00537407|OG000|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894445|NCT00537407|OG001|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894446|NCT00537407|OG002|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894447|NCT00537407|OG000|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894448|NCT00537407|OG001|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
11171364|NCT02002702|EG001|Reported Event|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
11171365|NCT02002702|EG002|Reported Event|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
10894449|NCT00537407|OG001|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894450|NCT00537407|OG002|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894451|NCT00537407|OG003|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894452|NCT00537407|OG004|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894453|NCT00537407|EG000|Reported Event|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894454|NCT00537407|EG001|Reported Event|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
11171366|NCT02002767|BG000|Baseline|Normal Renal Function|Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.
11171367|NCT02002767|BG001|Baseline|Severe Renal Impairment|Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.
11171368|NCT02002767|BG002|Baseline|Total|Total of all reporting groups
11171369|NCT02002767|FG000|Participant Flow|Normal Renal Function|Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.
11171370|NCT02002767|FG001|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.
11171371|NCT02002767|OG000|Outcome|Normal Renal Function|Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.
11171372|NCT02002767|OG001|Outcome|Severe Renal Impairment|Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.
11171373|NCT02002767|EG000|Reported Event|Normal Renal Function|Participants with normal renal function received velpatasvir 100 mg administered orally with a light breakfast on Day 1.
11171374|NCT02002767|EG001|Reported Event|Severe Renal Impairment|Participants with severe renal impairment received velpatasvir 100 mg administered orally with a light breakfast on Day 1.
11171375|NCT02002832|BG000|Baseline|Lurasidone Group|Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day
11171376|NCT02002832|BG001|Baseline|Risperidone Group|Risperidone 2-6mg taken orally once a day and Lurasidone placebo tablets taken orally once a day.
11171377|NCT02002832|BG002|Baseline|Total|Total of all reporting groups
11171378|NCT02002832|FG000|Participant Flow|Lurasidone Group|Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day
11171379|NCT02002832|FG001|Participant Flow|Risperidone Group|Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.
11171380|NCT02002832|OG000|Outcome|Lurasidone Group|Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.
11171381|NCT02002832|OG001|Outcome|Risperidone Group|Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.
11171382|NCT02002832|OG000|Outcome|Lurasidone Group|Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day
11171383|NCT02002832|EG000|Reported Event|Lurasidone Group|Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.
11171384|NCT02002832|EG001|Reported Event|Risperidone Group|Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.
11171385|NCT02002871|BG000|Baseline|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
11171386|NCT02002871|FG000|Participant Flow|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
10894455|NCT00537407|EG002|Reported Event|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894456|NCT00537407|EG003|Reported Event|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894457|NCT00537407|EG004|Reported Event|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
10894458|NCT00537485|BG000|Baseline|SPM962|transdermal application of SPM962, 1 time per day
10894459|NCT00537485|BG001|Baseline|Placebo|transdermal application of placebo, 1 time per day
10894460|NCT00537485|BG002|Baseline|Total|Total of all reporting groups
10894461|NCT00537485|FG000|Participant Flow|SPM962|transdermal application of SPM962, 1 time per day
10894462|NCT00537485|FG001|Participant Flow|Placebo|transdermal application of placebo, 1 time per day
10894463|NCT00537485|OG000|Outcome|SPM962|transdermal application of SPM962, 1 time per day
10894464|NCT00537485|OG001|Outcome|Placebo|transdermal application of placebo, 1 time per day
10894465|NCT00537485|EG000|Reported Event|SPM962|transdermal application of SPM962, 1 time per day
10894466|NCT00537485|EG001|Reported Event|Placebo|transdermal application of placebo, 1 time per day
10894467|NCT00537511|BG000|Baseline|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
10894468|NCT00537511|FG000|Participant Flow|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
10894469|NCT00537511|OG000|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
10894470|NCT00537511|OG000|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894471|NCT00537511|OG001|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894472|NCT00537511|OG002|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894473|NCT00537511|OG003|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894474|NCT00537511|OG004|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894475|NCT00537511|OG000|Outcome|Pomalidomide 1 mg|Participants received daily oral pomalidomide 1 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894476|NCT00537511|OG001|Outcome|Pomalidomide 3 mg|Participants received daily oral pomalidomide 3 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894477|NCT00537511|OG002|Outcome|Pomalidomide 4 mg|Participants received daily oral pomalidomide 4 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894478|NCT00537511|OG003|Outcome|Pomalidomide 5 mg|Participants received daily oral pomalidomide 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894479|NCT00537511|EG000|Reported Event|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894480|NCT00537511|EG001|Reported Event|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894481|NCT00537511|EG002|Reported Event|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894482|NCT00537511|EG003|Reported Event|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
10894483|NCT00537511|EG004|Reported Event|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
10894484|NCT00537576|BG000|Baseline|Low Dose Applicator|Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1
10894485|NCT00537576|BG001|Baseline|Medium Dose Applicator|Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1
10894486|NCT00537576|BG002|Baseline|High Dose Applicator|High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1
10894487|NCT00537576|BG003|Baseline|Placebo Control Substance Low Dose|Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.
10894488|NCT00537576|BG004|Baseline|Placebo Control Substance Medium Dose|Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.
10894489|NCT00537576|BG005|Baseline|Placebo Control Substance High Dose|Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
10894490|NCT00537576|BG006|Baseline|Total|Total of all reporting groups
10894491|NCT00537576|FG000|Participant Flow|Low Dose Applicator|Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1
10894492|NCT00537576|FG001|Participant Flow|Medium Dose Applicator|Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1
10894493|NCT00537576|FG002|Participant Flow|High Dose Applicator|High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1
10894494|NCT00537576|FG003|Participant Flow|Placebo Control Substance Low Dose|Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.
10894495|NCT00537576|FG004|Participant Flow|Placebo Control Substance Medium Dose|Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.
10894496|NCT00537576|FG005|Participant Flow|Placebo Control Substance High Dose|Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
10894497|NCT00537576|OG000|Outcome|Low Dose Applicator|Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1
10894498|NCT00537576|OG001|Outcome|Medium Dose Applicator|Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1
10894499|NCT00537576|OG002|Outcome|High Dose Applicator|High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1
10894500|NCT00537576|OG003|Outcome|Placebo Control Substance Low Dose|Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.
10894501|NCT00537576|OG004|Outcome|Placebo Control Substance Medium Dose|Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.
10894502|NCT00537576|OG005|Outcome|Placebo Control Substance High Dose|Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
10894503|NCT00537576|EG000|Reported Event|Low Dose Applicator|Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1
10894504|NCT00537576|EG001|Reported Event|Medium Dose Applicator|Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1
10894505|NCT00537576|EG002|Reported Event|High Dose Applicator|High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1
10894506|NCT00537576|EG003|Reported Event|Placebo Control Substance Low Dose|Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.
10894507|NCT00537576|EG004|Reported Event|Placebo Control Substance Medium Dose|Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.
10894508|NCT00537576|EG005|Reported Event|Placebo Control Substance High Dose|Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
10894509|NCT00537680|BG000|Baseline|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
10894510|NCT00537680|BG001|Baseline|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
10894511|NCT00537680|BG002|Baseline|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
10894512|NCT00537680|BG003|Baseline|Total|Total of all reporting groups
10894513|NCT00537680|FG000|Participant Flow|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
10894514|NCT00537680|FG001|Participant Flow|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
10894515|NCT00537680|FG002|Participant Flow|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
10894516|NCT00537680|OG000|Outcome|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
10894517|NCT00537680|OG001|Outcome|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
10894518|NCT00537680|OG002|Outcome|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
10894519|NCT00537680|EG000|Reported Event|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
10894520|NCT00537680|EG001|Reported Event|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
10894521|NCT00537680|EG002|Reported Event|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
10894522|NCT00537745|BG000|Baseline|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
11171387|NCT02002871|OG000|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
10894523|NCT00537745|FG000|Participant Flow|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
10894524|NCT00537745|OG000|Outcome|Participants|Intervention Group
11171388|NCT02002871|OG001|Outcome|Control|Contralateral untreated control plaque on the same patient.
10894525|NCT00537745|OG000|Outcome|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
10894526|NCT00537745|EG000|Reported Event|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
10894527|NCT00537771|BG000|Baseline|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
10894528|NCT00537771|BG001|Baseline|TAM Group|Tamoxifen : 20 mg once daily oral dose
10894529|NCT00537771|BG002|Baseline|Total|Total of all reporting groups
10894530|NCT00537771|FG000|Participant Flow|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
10894531|NCT00537771|FG001|Participant Flow|TAM Group|Tamoxifen : 20 mg once daily oral dose
10894532|NCT00537771|OG000|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
10894533|NCT00537771|OG001|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
10894534|NCT00537771|EG000|Reported Event|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
10894535|NCT00537771|EG001|Reported Event|TAM Group|Tamoxifen : 20 mg once daily oral dose
10894536|NCT00537810|BG000|Baseline|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
10894537|NCT00537810|BG001|Baseline|Placebo|"Placebo Daily~Placebo: Daily"
10894538|NCT00537810|BG002|Baseline|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
10894539|NCT00537810|BG003|Baseline|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
10894540|NCT00537810|BG004|Baseline|Total|Total of all reporting groups
10894541|NCT00537810|FG000|Participant Flow|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
10894542|NCT00537810|FG001|Participant Flow|Placebo|"Placebo Daily~Placebo: Daily"
10894543|NCT00537810|FG002|Participant Flow|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
10894544|NCT00537810|FG003|Participant Flow|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
10894545|NCT00537810|OG000|Outcome|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
10894546|NCT00537810|OG001|Outcome|Placebo|"Placebo Daily~Placebo: Daily"
10894547|NCT00537810|OG002|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
10894548|NCT00537810|OG003|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
10894549|NCT00537810|EG000|Reported Event|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
10894550|NCT00537810|EG001|Reported Event|Placebo|"Placebo Daily~Placebo: Daily"
11171389|NCT02002871|EG000|Reported Event|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
10894551|NCT00537810|EG002|Reported Event|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
10894552|NCT00537810|EG003|Reported Event|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
10894553|NCT00537823|BG000|Baseline|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m2 IV weekly"
10894554|NCT00537823|BG001|Baseline|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2"
10894555|NCT00537823|BG002|Baseline|Total|Total of all reporting groups
10894556|NCT00537823|FG000|Participant Flow|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m2 IV weekly"
10894557|NCT00537823|FG001|Participant Flow|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2"
10894558|NCT00537823|OG000|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
10894559|NCT00537823|OG001|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
10914783|NCT00632749|OG012|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11171390|NCT02002884|BG000|Baseline|MP Low Dose Group|Participants in low dose group received intramuscular injections of 2 U/kg NT 201 (maximum of 50 U in participants with >25 kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 2 U/kg (50 U for participants with >25kg BW) to 5 U/kg (125 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171391|NCT02002884|BG001|Baseline|MP Mid Dose Group|Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171392|NCT02002884|BG002|Baseline|MP High Dose Group|Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171393|NCT02002884|BG003|Baseline|Total|Total of all reporting groups
11233221|NCT02424799|OG000|Outcome|Part A-GSK2646264 0.5%|Participants were treated topically with GSK2646264 0.5% cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
10894560|NCT00537823|OG000|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
10894561|NCT00537823|EG000|Reported Event|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
10894562|NCT00537823|EG001|Reported Event|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
10894563|NCT00537940|BG000|Baseline|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
10894564|NCT00537940|BG001|Baseline|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
10894565|NCT00537940|BG002|Baseline|Total|Total of all reporting groups
11171394|NCT02002884|FG000|Participant Flow|MP Low Dose Group|Participants in low dose group received intramuscular injections of 2 Units per kilogram (U/kg) NT 201 (maximum of 50 Units [U] in participants with greater than [>] 25 kilogram [kg] body weight [BW]) into spastic muscles of one of the upper Limb (UL) on Day 1 of MP. If the contralateral UL or one or both lower limb (LL) were also treated, participants received additional doses of NT 201. The total body dose ranged from 2 U/kg (50 U for participants with >25kg BW) to 5 U/kg (125 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's Gross Motor Function Classification System (GMFCS) level.
11171395|NCT02002884|FG001|Participant Flow|MP Mid Dose Group|Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171396|NCT02002884|FG002|Participant Flow|MP High Dose Group|Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171397|NCT02002884|FG003|Participant Flow|OLEX (3 Injections)|Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171398|NCT02002884|OG000|Outcome|MP Low Dose Group|Participants in low dose group received intramuscular injections of 2 U/kg NT 201 (maximum of 50 U in participants with >25 kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 2 U/kg (50 U for participants with >25kg BW) to 5 U/kg (125 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11233222|NCT02424799|OG000|Outcome|Part B-Placebo|CU participants received matching placebo treatment to an area of 10% BSA (5% BSA on each arm, n=1) or 3.5% BSA (spread over the 2 arms, n=2) on days 1, 2 and 3.
11171399|NCT02002884|OG001|Outcome|MP Mid Dose Group|Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171400|NCT02002884|OG002|Outcome|MP High Dose Group|Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171401|NCT02002884|OG003|Outcome|OLEX (3 Injections)|Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171402|NCT02002884|EG000|Reported Event|MP Low Dose Group|Participants in low dose group received intramuscular injections of 2 U/kg NT 201 (maximum of 50 U in participants with >25 kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 2 U/kg (50 U for participants with >25kg BW) to 5 U/kg (125 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171403|NCT02002884|EG001|Reported Event|MP Mid Dose Group|Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171404|NCT02002884|EG002|Reported Event|MP High Dose Group|Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171405|NCT02002884|EG003|Reported Event|OLEX (3 Injections)|Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level.
11171406|NCT02002936|BG000|Baseline|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
11171407|NCT02002936|FG000|Participant Flow|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
11171408|NCT02002936|OG000|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
11171409|NCT02002936|EG000|Reported Event|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
11171410|NCT02002975|BG000|Baseline|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 3 years before or after breakfast in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11357450|NCT03757312|EG000|Reported Event|Fontan|"Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.~Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD)."
11171411|NCT02002975|FG000|Participant Flow|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 3 years before or after breakfast in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11171412|NCT02002975|OG000|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 3 years before or after breakfast in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11357451|NCT03757312|EG001|Reported Event|Non-Fontan|Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
11171413|NCT02002975|EG000|Reported Event|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 3 years before or after breakfast in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11171414|NCT02003014|BG000|Baseline|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
11171415|NCT02003014|FG000|Participant Flow|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
11171416|NCT02003014|OG000|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
11171417|NCT02003014|EG000|Reported Event|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
11171418|NCT02003053|BG000|Baseline|Inpsiratory Muscle Training|"In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
11171419|NCT02003053|BG001|Baseline|Sham|"In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
11171420|NCT02003053|BG002|Baseline|Total|Total of all reporting groups
11171421|NCT02003053|FG000|Participant Flow|Inspiratory Muscle Training|"In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
11171422|NCT02003053|FG001|Participant Flow|Sham|"In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
11171423|NCT02003053|OG000|Outcome|Inspiratory Muscle Training|"In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
11171424|NCT02003053|OG001|Outcome|Sham|"In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
11171425|NCT02003053|EG000|Reported Event|Inspiratory Muscle Training Group|"In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
11171426|NCT02003053|EG001|Reported Event|Sham Group|"In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
11171427|NCT02003183|BG000|Baseline|Military Personnel|Military personnel with a history of head trauma and cognitive or mood symptoms.
11171428|NCT02003183|BG001|Baseline|Players|Retired football players with a history of head trauma and cognitive or mood symptoms.
11171429|NCT02003183|BG002|Baseline|Total|Total of all reporting groups
11171430|NCT02003183|FG000|Participant Flow|Military Personnel|Military personnel with suspected chronic traumatic encephalopathy (CTE), each with a history of head trauma and cognitive or mood symptoms.
11171431|NCT02003183|FG001|Participant Flow|Players|Retired football players with suspected CTE, each with a history of head trauma and cognitive or mood symptoms.
11171432|NCT02003183|OG000|Outcome|Military Personnel|Military personnel with a history of head trauma and cognitive or mood symptoms.
11171433|NCT02003183|OG001|Outcome|Players|Retired football players with a history of head trauma and cognitive or mood symptoms.
11171434|NCT02003183|EG000|Reported Event|Military Personnel|Military personnel with a history of head trauma and cognitive or mood symptoms.
11171435|NCT02003183|EG001|Reported Event|Players|Retired football players with a history of head trauma and cognitive or mood symptoms.
11171436|NCT02003352|BG000|Baseline|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.~The study population consisted of 98 combat veterans who had suffered aT BI with PTSD, referred to our study by Veteran's groups. All subjects were male with a mean age of 39 years with a minimum age of 20 years and a maximum age of 60 years.They all met the inclusion requirements and did not have any of the exclusion requirements."
11171437|NCT02003352|FG000|Participant Flow|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
11171438|NCT02003352|OG000|Outcome|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
11233223|NCT02424799|OG001|Outcome|Part B GSK2646264 1%|CU participants received 1% strength GSK2646264 to an area of 10% BSA (5% BSA on each arm, n=3) or 3% BSA (spread over the 2 arms, n=6) on days 1, 2 and 3.
11171439|NCT02003352|EG000|Reported Event|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
11171440|NCT02003365|BG000|Baseline|FX006 10 mg|Single 3 mL IA injection
11171441|NCT02003365|BG001|Baseline|FX006 40 mg|Single 3 mL IA injection
11171442|NCT02003365|BG002|Baseline|TCA IR 40 mg|Single 1 mL IA injection
11171443|NCT02003365|BG003|Baseline|Total|Total of all reporting groups
11171444|NCT02003365|FG000|Participant Flow|FX006 10 mg|10 subjects received FX006 10 mg as a single 3 mL IA injection
11171445|NCT02003365|FG001|Participant Flow|FX006 40 mg|30 Subjects received FX006 40 mg as a single 3 mL IA injection
11171446|NCT02003365|FG002|Participant Flow|TCA IR 40 mg|10 subjects received TCA IR 40 mg as a single 1 mL IA injection
11171447|NCT02003365|OG000|Outcome|FX006 10 mg|Single 3 mL IA injection.
11171448|NCT02003365|OG001|Outcome|FX006 40 mg|Single 3 mL IA injection.
11171449|NCT02003365|OG002|Outcome|TCA IR 40 mg|Single 1 mL IA injection.
11171450|NCT02003365|EG000|Reported Event|FX006 10 mg|Single 3 mL IA injection
11171451|NCT02003365|EG001|Reported Event|FX006 40 mg|Single 3 mL IA injection
11171452|NCT02003365|EG002|Reported Event|TCA IR|Single 1 mL IA injection
11171453|NCT02003391|BG000|Baseline|DuoTrav|Travoprost/timolol for 8 weeks
11171454|NCT02003391|BG001|Baseline|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
11171455|NCT02003391|BG002|Baseline|Total|Total of all reporting groups
11171456|NCT02003391|FG000|Participant Flow|DuoTrav|Travoprost/timolol for 8 weeks
11171457|NCT02003391|FG001|Participant Flow|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
11171458|NCT02003391|OG000|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
11171459|NCT02003391|OG001|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
11171460|NCT02003391|EG000|Reported Event|DuoTrav|Travoprost/timolol for 8 weeks
11171461|NCT02003391|EG001|Reported Event|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
11171462|NCT02003404|BG000|Baseline|Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate.
11171463|NCT02003404|FG000|Participant Flow|Abdominal Skin Barrier Peel Force|"Barrier materials were attached and peeled off control and peristomal abdominal skin.~Three commercial barrier materials (SoftFlex, FlexWear and FlexTend) were peeled from control or peristomal abdominal skin after a set period at a set rate."
11171464|NCT02003404|OG000|Outcome|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
11171465|NCT02003404|OG001|Outcome|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
11171466|NCT02003404|EG000|Reported Event|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
11171467|NCT02003404|EG001|Reported Event|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
11171468|NCT02003508|BG000|Baseline|Pre-vaccination Period|Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program.
11171469|NCT02003508|BG001|Baseline|Post-vaccination Period|Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction
11171470|NCT02003508|BG002|Baseline|Total|Total of all reporting groups
11171471|NCT02003508|FG000|Participant Flow|Phase 1 (2014-2015)|Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program. Accordingly, most of these men were unvaccinated against 4HPV.
11171472|NCT02003508|FG001|Participant Flow|Phase 2 (2016-2017)|Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction. Accordingly, many participants in this group had received the HPV vaccination.
11171473|NCT02003508|OG000|Outcome|Phase 1 (2014-2015)|Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program.
11171474|NCT02003508|OG001|Outcome|Phase 2 (2016-2017)|Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction
11171475|NCT02003508|EG000|Reported Event|Phase 1 (2014-2015)|"Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program.~Nil adverse events."
11171476|NCT02003508|EG001|Reported Event|Phase 2 (2016-2017)|"Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction.~Nil adverse events."
11171477|NCT02003534|BG000|Baseline|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
11171478|NCT02003534|FG000|Participant Flow|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
11171479|NCT02003534|OG000|Outcome|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
11171480|NCT02003534|EG000|Reported Event|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
11171481|NCT02003573|BG000|Baseline|Volasertib 300 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 300 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171482|NCT02003573|BG001|Baseline|Volasertib 350 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 350 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171483|NCT02003573|BG002|Baseline|Volasertib 400 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 400 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171484|NCT02003573|BG003|Baseline|Total|Total of all reporting groups
11171485|NCT02003573|FG000|Participant Flow|Volasertib 300 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 300 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171486|NCT02003573|FG001|Participant Flow|Volasertib 350 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 350 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
10894566|NCT00537940|FG000|Participant Flow|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
10894567|NCT00537940|FG001|Participant Flow|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
10894568|NCT00537940|OG000|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
10894569|NCT00537940|OG001|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
10914784|NCT00632749|OG013|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10894570|NCT00537940|EG000|Reported Event|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
10894571|NCT00537940|EG001|Reported Event|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
10894572|NCT00537979|BG000|Baseline|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
10894573|NCT00537979|BG001|Baseline|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
10894574|NCT00537979|BG002|Baseline|Total|Total of all reporting groups
10894575|NCT00537979|FG000|Participant Flow|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
10894576|NCT00537979|FG001|Participant Flow|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
10894577|NCT00537979|OG000|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
10894578|NCT00537979|OG001|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
10894579|NCT00537979|OG000|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
10894580|NCT00537979|EG000|Reported Event|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
10894581|NCT00537979|EG001|Reported Event|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
10894582|NCT00538213|BG000|Baseline|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
10894583|NCT00538213|BG001|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
11171487|NCT02003573|FG002|Participant Flow|Volasertib 400 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 400 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
10894584|NCT00538213|BG002|Baseline|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
10894585|NCT00538213|BG003|Baseline|Total|Total of all reporting groups
10894586|NCT00538213|FG000|Participant Flow|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
10894587|NCT00538213|FG001|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
10894588|NCT00538213|FG002|Participant Flow|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
10894589|NCT00538213|OG000|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
11171488|NCT02003573|OG000|Outcome|Volasertib + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle. The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171489|NCT02003573|OG000|Outcome|Volasertib 300 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 300 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171490|NCT02003573|OG001|Outcome|Volasertib 350 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 350 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171491|NCT02003573|OG002|Outcome|Volasertib 400 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 400 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171492|NCT02003573|EG000|Reported Event|Volasertib 300 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 300 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171493|NCT02003573|EG001|Reported Event|Volasertib 350 mg + Decitabine|"Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5).~Volasertib 350 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle.~The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication."
11171494|NCT02003573|EG002|Reported Event|Volasertib 400 mg + Decitabine|Patients were treated according to dosing Schedule A in which decitabine (Dacogen®; solution for infusion) 20 mg/m2 was to be administered (Intravenous infusion) for the first 5 consecutive days of the treatment cycle (Day 1 to Day 5). Volasertib 400 mg (solution for infusion) was administered (Intravenous infusion) on Days 1 and 15 of the treatment cycle. The duration of a treatment cycle was 28 days. Number of treatment cycles was unlimited until the patient met criteria for stopping study medication.
11171495|NCT02003573|EG003|Reported Event|Total|Total of all arms
11171496|NCT02003625|BG000|Baseline|A. GCSF + Placebo|"GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis [days -4, -3, -2, -1] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.~GCSF~Placebo"
11171497|NCT02003625|BG001|Baseline|B. GCSF + Meloxicam|"B. GCSF + meloxicam:~Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10^6 CD34+ cells/kg are collected.~GCSF~meloxicam"
11171498|NCT02003625|BG002|Baseline|Total|Total of all reporting groups
11171499|NCT02003625|FG000|Participant Flow|A. GCSF + Placebo|"GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis [days -4, -3, -2, -1] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.~GCSF~Placebo"
11171500|NCT02003625|FG001|Participant Flow|B. GCSF + Meloxicam|"B. GCSF + meloxicam:~Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10^6 CD34+ cells/kg are collected.~GCSF~meloxicam"
11171501|NCT02003625|OG000|Outcome|A. GCSF + Placebo|"GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis [days -4, -3, -2, -1] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.~GCSF~Placebo"
11171502|NCT02003625|OG001|Outcome|B. GCSF + Meloxicam|"B. GCSF + meloxicam:~Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10^6 CD34+ cells/kg are collected.~GCSF~meloxicam"
11171503|NCT02003625|EG000|Reported Event|A. GCSF + Placebo|"GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis [days -4, -3, -2, -1] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.~GCSF~Placebo"
11171504|NCT02003625|EG001|Reported Event|B. GCSF + Meloxicam|"B. GCSF + meloxicam:~Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10^6 CD34+ cells/kg are collected.~GCSF~meloxicam"
11171505|NCT02003638|BG000|Baseline|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
11171506|NCT02003638|BG001|Baseline|Placebo|Placebo taken orally every day for 12 weeks
11171507|NCT02003638|BG002|Baseline|Total|Total of all reporting groups
11171508|NCT02003638|FG000|Participant Flow|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
11171509|NCT02003638|FG001|Participant Flow|Placebo|Placebo taken orally every day for 12 weeks
11171510|NCT02003638|OG000|Outcome|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
11171511|NCT02003638|OG001|Outcome|Placebo|Placebo taken orally every day for 12 weeks
11171512|NCT02003638|EG000|Reported Event|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
11171513|NCT02003638|EG001|Reported Event|Placebo|Placebo taken orally every day for 12 weeks
10894590|NCT00538213|OG001|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
11171514|NCT02003898|BG000|Baseline|Medtronic MiniMed 530G Insulin Pump|"All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.~Medtronic MiniMed 530G Insulin Pump"
11171515|NCT02003898|FG000|Participant Flow|Medtronic MiniMed 530G Insulin Pump|"All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.~Medtronic MiniMed 530G Insulin Pump"
10894591|NCT00538213|OG002|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
11171516|NCT02003898|OG000|Outcome|Medtronic MiniMed 530G Insulin Pump|"All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.~Medtronic MiniMed 530G Insulin Pump"
11171517|NCT02003898|EG000|Reported Event|Medtronic MiniMed 530G Insulin Pump|"All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.~Medtronic MiniMed 530G Insulin Pump"
11171518|NCT02003911|BG000|Baseline|Azithromycin Suspension|"Azithromycin suspension at 10mg/kg/dose (max 500mg)~Once daily for 3 days~Azithromycin: Azithromycin suspension (200mg/5mL)"
11171519|NCT02003911|BG001|Baseline|Placebo Suspension|"Same volume as active drug~Once daily for 3 days~Placebo"
11171520|NCT02003911|BG002|Baseline|Total|Total of all reporting groups
11171521|NCT02003911|FG000|Participant Flow|Azithromycin Suspension|"Azithromycin suspension at 10mg/kg/dose (max 500mg)~Once daily for 3 days~Azithromycin: Azithromycin suspension (200mg/5mL)"
11171522|NCT02003911|FG001|Participant Flow|Placebo Suspension|"Same volume as active drug~Once daily for 3 days~Placebo"
11171523|NCT02003911|OG000|Outcome|Azithromycin Suspension|"Azithromycin suspension at 10mg/kg/dose (max 500mg)~Once daily for 3 days~Azithromycin: Azithromycin suspension (200mg/5mL)"
11171524|NCT02003911|OG001|Outcome|Placebo Suspension|"Same volume as active drug~Once daily for 3 days~Placebo"
11171525|NCT02003911|EG000|Reported Event|Azithromycin Suspension|"Azithromycin suspension at 10mg/kg/dose (max 500mg)~Once daily for 3 days~Azithromycin: Azithromycin suspension (200mg/5mL)"
11171526|NCT02003911|EG001|Reported Event|Placebo Suspension|"Same volume as active drug~Once daily for 3 days~Placebo"
11171527|NCT02003963|BG000|Baseline|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
11171528|NCT02003963|BG001|Baseline|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
11171529|NCT02003963|BG002|Baseline|Total|Total of all reporting groups
11171530|NCT02003963|FG000|Participant Flow|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.~Klub Kinect: Dance Central and Just Dance are a series of rhythm games developed by Harmonix Music Systems exclusively for the Xbox 360 Kinect. The Dance Central suite of games (Dance Central 1, 2, and 3) and Just Dance will be played on the Xbox 360+ Kinect gaming console, which employs whole body movement using an infrared sensor that tracks body movements such that an external controller device is not required. The player performs dance moves demonstrated by on-screen characters and set to popular music, with a choice of over 650 dance moves, 90 dance routines, and over 300 songs."
11171531|NCT02003963|FG001|Participant Flow|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
11171532|NCT02003963|OG000|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
11171533|NCT02003963|OG001|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
11171534|NCT02003963|OG000|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
11171535|NCT02003963|OG000|Outcome|Exergame Intervention|Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
11171536|NCT02003963|EG000|Reported Event|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
11171537|NCT02003963|EG001|Reported Event|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
11171538|NCT02004093|BG000|Baseline|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
10894592|NCT00538213|OG000|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
10894593|NCT00538213|EG000|Reported Event|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
10894594|NCT00538213|EG001|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
10894595|NCT00538213|EG002|Reported Event|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
10894596|NCT00538291|BG000|Baseline|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
10894597|NCT00538291|FG000|Participant Flow|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
10894598|NCT00538291|OG000|Outcome|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
10894599|NCT00538291|EG000|Reported Event|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
10894600|NCT00538304|BG000|Baseline|Bimatoprost Eye Drops|Bimatoprost eye drops
10894601|NCT00538304|BG001|Baseline|Placebo|Placebo
10894602|NCT00538304|BG002|Baseline|Total|Total of all reporting groups
10894603|NCT00538304|FG000|Participant Flow|Bimatoprost Eye Drops|Bimatoprost eye drops
10894604|NCT00538304|FG001|Participant Flow|Placebo|Placebo
10894605|NCT00538304|OG000|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
10894606|NCT00538304|OG001|Outcome|Placebo|Placebo
10894607|NCT00538304|EG000|Reported Event|Bimatoprost Eye Drops|Bimatoprost eye drops
11171539|NCT02004093|BG001|Baseline|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
11171540|NCT02004093|BG002|Baseline|Total|Total of all reporting groups
11233224|NCT02424799|OG000|Outcome|Part A-GSK2646264 0.5%|Participants were treated topically with GSK2646264 0.5% cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3
10894608|NCT00538304|EG001|Reported Event|Placebo|Placebo
10894609|NCT00538434|BG000|Baseline|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894610|NCT00538434|BG001|Baseline|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894611|NCT00538434|BG002|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894612|NCT00538434|BG003|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894613|NCT00538434|BG004|Baseline|Total|Total of all reporting groups
10894614|NCT00538434|FG000|Participant Flow|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894615|NCT00538434|FG001|Participant Flow|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894616|NCT00538434|FG002|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894617|NCT00538434|FG003|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894618|NCT00538434|OG000|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894619|NCT00538434|OG001|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894620|NCT00538434|OG002|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894621|NCT00538434|OG003|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894622|NCT00538434|OG001|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894623|NCT00538434|EG000|Reported Event|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894624|NCT00538434|EG001|Reported Event|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894625|NCT00538434|EG002|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894626|NCT00538434|EG003|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
10894627|NCT00538473|BG000|Baseline|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
10894628|NCT00538473|BG001|Baseline|Fluarix Group|Subjects received 1 dose of Fluarix™.
10894629|NCT00538473|BG002|Baseline|Total|Total of all reporting groups
10894630|NCT00538473|FG000|Participant Flow|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
10894631|NCT00538473|FG001|Participant Flow|Fluarix Group|Subjects received 1 dose of Fluarix™.
10894632|NCT00538473|OG000|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
10894633|NCT00538473|OG001|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
10894634|NCT00538473|EG000|Reported Event|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
10894635|NCT00538473|EG001|Reported Event|Fluarix Group|Subjects received 1 dose of Fluarix™.
10894636|NCT00538512|BG000|Baseline|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
10894637|NCT00538512|BG001|Baseline|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
10894638|NCT00538512|BG002|Baseline|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
10894639|NCT00538512|BG003|Baseline|Total|Total of all reporting groups
10894640|NCT00538512|FG000|Participant Flow|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
10894641|NCT00538512|FG001|Participant Flow|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
10894642|NCT00538512|FG002|Participant Flow|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
10894643|NCT00538512|OG000|Outcome|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
10894644|NCT00538512|OG001|Outcome|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
10894645|NCT00538512|OG002|Outcome|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
10894646|NCT00538512|EG000|Reported Event|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
10894647|NCT00538512|EG001|Reported Event|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
10894648|NCT00538512|EG002|Reported Event|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
10894649|NCT00538590|BG000|Baseline|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
10894650|NCT00538590|BG001|Baseline|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
10894651|NCT00538590|BG002|Baseline|Total|Total of all reporting groups
10894652|NCT00538590|FG000|Participant Flow|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
10894653|NCT00538590|FG001|Participant Flow|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
10894654|NCT00538590|OG000|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
10894655|NCT00538590|OG001|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
10894656|NCT00538590|EG000|Reported Event|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
10894657|NCT00538590|EG001|Reported Event|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
10894658|NCT00538616|BG000|Baseline|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
10894659|NCT00538616|BG001|Baseline|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
10894660|NCT00538616|BG002|Baseline|Total|Total of all reporting groups
10894661|NCT00538616|FG000|Participant Flow|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
10894662|NCT00538616|FG001|Participant Flow|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
10894663|NCT00538616|OG000|Outcome|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
10894664|NCT00538616|OG001|Outcome|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
10894665|NCT00538616|EG000|Reported Event|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
10894666|NCT00538616|EG001|Reported Event|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
10894667|NCT00538629|BG000|Baseline|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
10894668|NCT00538629|FG000|Participant Flow|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
10894669|NCT00538629|OG000|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
10894670|NCT00538629|EG000|Reported Event|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
10894671|NCT00538642|BG000|Baseline|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
10894672|NCT00538642|BG001|Baseline|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
10894673|NCT00538642|BG002|Baseline|Total|Total of all reporting groups
10894674|NCT00538642|FG000|Participant Flow|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
10894675|NCT00538642|FG001|Participant Flow|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
10894676|NCT00538642|OG000|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
10894677|NCT00538642|OG001|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
10894678|NCT00538642|EG000|Reported Event|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
10894679|NCT00538642|EG001|Reported Event|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
10894680|NCT00538681|BG000|Baseline|Part 1- Cohort 1|"Cycle 1: 500 mg enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle.~Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894681|NCT00538681|BG001|Baseline|Part 1- Cohort 2|"Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle.~Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
11233225|NCT02424799|OG000|Outcome|Part A-Placebo (Group 1)|Participants were treated topically with matching placebo cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
10894682|NCT00538681|BG002|Baseline|Part 2- Enzastaurin|"Cycle 1: 375 mg enzastaurin po 3 times on Day 1 as a loading dose and 250 mg po BID on Day 2 to 28 of a 28-day cycle, then 500 mg/m² IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle.~Cycle 2 to 6: 250 mg enzastaurin po BID on Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894683|NCT00538681|BG003|Baseline|Part 2- Placebo|"Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle.~Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle."
10894684|NCT00538681|BG004|Baseline|Other|500 mg/m² pemetrexed and 75 mg/m² cisplatin administered intravenously
10894685|NCT00538681|BG005|Baseline|Total|Total of all reporting groups
10894686|NCT00538681|FG000|Participant Flow|Part 1- Cohort 1|"Cycle 1: 500 milligrams (mg) enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle.~Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894687|NCT00538681|FG001|Participant Flow|Part 1- Cohort 2|"Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle.~Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894688|NCT00538681|FG002|Participant Flow|Part 2- Enzastaurin|"Cycle 1: 375 mg enzastaurin po 3 times on Day 1 as a loading dose and 250 mg po BID on Day 2 to 28 of a 28-day cycle, then 500 mg/m² IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle.~Cycle 2 to 6: 250 mg enzastaurin po BID on Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894689|NCT00538681|FG003|Participant Flow|Part 2- Placebo|"Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle.~Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle."
10894690|NCT00538681|OG000|Outcome|Part 1- Cohort 1|"Cycle 1: 500 mg enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle.~Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894691|NCT00538681|OG001|Outcome|Part 1- Cohort 2|"Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle.~Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894692|NCT00538681|OG000|Outcome|Part 2- Enzastaurin|"Cycle 1: 375 milligrams (mg) enzastaurin orally (po) 3 times on Day 1 as a loading dose and 250 mg po twice daily (BID) on Day 2 to 28 of a 28-day cycle, then 500 milligrams per square meter (mg/m²) intravenous (IV) followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle.~Cycle 2 to 6: 250 mg enzastaurin po BID on Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894693|NCT00538681|OG001|Outcome|Part 2- Placebo|"Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle.~Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle."
10894694|NCT00538681|EG000|Reported Event|Part 1- Cohort 1|"Cycle 1: 500 mg Enzastaurin orally as loading dose on Day 1 of a 28-day cycle and 125 mg orally twice daily, plus 500 mg/m2 pemetrexed intravenous (IV) and 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle.~Cycles 2-6: 125 mg Enzastaurin orally twice daily, with 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 1 of each 21-day cycle."
11233226|NCT02424799|OG001|Outcome|Part A-GSK2646264 0.5% (Group 1)|Participants were treated topically with GSK2646264 0.5% cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
11233227|NCT02424799|OG002|Outcome|Part A-Placebo (Group 2)|Participants received placebo on Days 1, 2, 3 and 4. On Day 1 and Day 2, participants received treatment to 0.2% BSA; placebo treatment to one arm. In addition, participants received treatment to another 5% BSA; placebo to one side of the torso. On Days 3 and 4, the same treatment to the arms was applied as on Days 1 and 2, but the %BSA of the torso to which treatment was applied to was increased to 10%.
11233228|NCT02424799|OG003|Outcome|Part A-GSK2646264 1% (Group 2)|Participants received active treatment (1% cream strength) on Days 1, 2, 3 and 4. On Day 1 and Day 2, participants received treatment to 0.2% BSA; active treatment on one arm. In addition, participants received treatment to another 5% BSA; active to one side of the torso. On Days 3 and 4, the same treatment to the arms was applied as on Days 1 and 2, but the %BSA of the torso to which treatment was applied to was increased to 10%.
11233229|NCT02424799|OG000|Outcome|Part A-GSK2646264 1%|Participants were treated topically with 0.5 % GSK2646264 cream and placebo cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
11233230|NCT02424799|OG000|Outcome|Part B (10% BSA) GSK2646264 1%|CU participants received matching placebo treatment to an area of 10% BSA (5% BSA each arm) on Days 1, 2 and 3.
11233231|NCT02424799|OG001|Outcome|Part B (3.5% BSA) GSK2646264 1%|CU participants received 1% strength GSK2646264 treatment to an area of 3.5% BSA (spread over the 2 arms) on Days 1, 2 and 3.
11233232|NCT02424799|OG000|Outcome|Part C GSK2646264 1%|CSU participants received 1% strength GSK2646264 to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
11233233|NCT02424799|OG000|Outcome|Part A-GSK2646264 0.5%|Participants were treated topically with GSK2646264 0.5% cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants recieved active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
11233234|NCT02424799|OG000|Outcome|Part B (10% BSA) GSK2646264 1%|CU participants received 1% strength GSK2646264 treatment to an area of 10% BSA (5% BSA on each arm) on Days 1, 2 and 3.
11233235|NCT02424799|EG000|Reported Event|Part A-GSK2646264 0.5%|Participants were treated topically with GSK2646264 0.5% cream on an area of approximately 12 x 3 cm on the volar aspect of the arm which approximated to 0.2% total BSA, on each arm. On Day 2 and Day 3 participants received active treatment and placebo on the same arms as on Day 1, with the percentage BSA being 1% on Day 2 and 5% on Day 3.
11233236|NCT02424799|EG001|Reported Event|Part A-GSK2646264 1%|Participants received active treatment (1% cream strength) on Days 1, 2, 3 and 4. On Day 1 and Day 2, participants received treatment to 0.2% BSA; active treatment on one arm. In addition, participants received treatment to another 5% BSA; active to one side of the torso. On Days 3 and 4, the same treatment to the arms was applied as on Days 1 and 2, but the %BSA of the torso to which treatment was applied to was increased to 10%.
11090465|NCT01529346|BG001|Baseline|PF-05089771 450 mg|Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11233237|NCT02424799|EG002|Reported Event|Part B (10% BSA)-Placebo|CU participants received matching placebo treatment to an area of 10% BSA (5% BSA each arm) on Days 1, 2 and 3.
11233238|NCT02424799|EG003|Reported Event|Part B (10% BSA) GSK2646264 1%|CU participants received 1% strength GSK2646264 treatment to an area of 10% BSA (5% BSA on each arm) on Days 1, 2 and 3.
11233239|NCT02424799|EG004|Reported Event|Part B (3.5% BSA)-Placebo|CU participants received matching placebo treatment to an area of 3.5% BSA (spread over the 2 arms) on Days 1, 2 and 3.
11233240|NCT02424799|EG005|Reported Event|Part B (3.5% BSA) GSK2646264 1%|CU participants received 1% strength GSK2646264 treatment to an area of 3.5% BSA (spread over the 2 arms) on Days 1, 2 and 3.
11233241|NCT02424799|EG006|Reported Event|Part C-Placebo|CSU participants received matching placebo treatment to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
11233242|NCT02424799|EG007|Reported Event|Part C GSK2646264 1%|CSU participants received 1% strength GSK2646264 to 10% BSA (arms, legs or torso) on Days 1, 4 and 7.
11233243|NCT02424968|BG000|Baseline|Infusion of Allogeneic CD8+ Memory T-cells|"All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT).~Anti-Thymocyte Globulin: Given per standard institutional practice~Cyclosporine: Given PO~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT~Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV~Total Nodal Irradiation: Undergo TLI"
11233244|NCT02424968|FG000|Participant Flow|Infusion of Allogeneic CD8+ Memory T-cells|"All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT).~Anti-Thymocyte Globulin: Given per standard institutional practice~Cyclosporine: Given PO~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT~Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV~Total Nodal Irradiation: Undergo TLI"
11233245|NCT02424968|OG000|Outcome|Infusion of Allogeneic CD8+ Memory T-cells|"All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT).~Anti-Thymocyte Globulin: Given per standard institutional practice~Cyclosporine: Given PO~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT~Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV~Total Nodal Irradiation: Undergo TLI"
11233246|NCT02424968|EG000|Reported Event|Infusion of Allogeneic CD8+ Memory T-cells|"All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT).~Anti-Thymocyte Globulin: Given per standard institutional practice~Cyclosporine: Given PO~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT~Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV~Total Nodal Irradiation: Undergo TLI"
11233247|NCT02425098|BG000|Baseline|High-dose Tetravalent Dengue Vaccine (HD-TDV)|High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
11233248|NCT02425098|BG001|Baseline|Tetravalent Dengue Vaccine (TDV)|Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2*10^4 plaque forming units (PFU), 5*10^3 PFU, 1*10^5 PFU, and 3*10^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
11233249|NCT02425098|BG002|Baseline|Total|Total of all reporting groups
11233250|NCT02425098|FG000|Participant Flow|High-dose Tetravalent Dengue Vaccine (HD-TDV)|High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
11233251|NCT02425098|FG001|Participant Flow|Tetravalent Dengue Vaccine (TDV)|Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2*10^4 plaque forming units (PFU), 5*10^3 PFU, 1*10^5 PFU, and 3*10^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
11233252|NCT02425098|OG000|Outcome|High-dose Tetravalent Dengue Vaccine (HD-TDV)|High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
11233253|NCT02425098|OG001|Outcome|Tetravalent Dengue Vaccine (TDV)|Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2*10^4 plaque forming units (PFU), 5*10^3 PFU, 1*10^5 PFU, and 3*10^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
10894695|NCT00538681|EG001|Reported Event|Part 1- Cohort 2|"Cycle 1: 1125 mg Enzastaurin orally as loading dose on Day 1 of a 28-day cycle and 250 mg orally twice daily starting on Day 2, plus 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle.~Cycles 2-6: 250 mg Enzastaurin orally twice daily, with 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 1 of each 21-day cycle."
10894696|NCT00538681|EG002|Reported Event|Part 2- Enzastaurin|"Cycle 1: 375 mg Enzastaurin orally 3 times on Day 1 of a 28-day cycle and 250 mg orally twice daily starting on Day 2, plus 500 mg/m² pemetrexed intravenously (IV) and 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle.~Cycle 2-6: 250 mg Enzastaurin orally twice daily on Days 1 to 21 (21-day cycles) with 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on day 1 of each 21-day cycle."
10894697|NCT00538681|EG003|Reported Event|Part 2- Placebo|"Cycle 1: Placebo was administered orally 3 times on Day 1 and 2 times a day on Days 2-28 (28-day cycle) plus 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on Day 8 of cycle (28-day cycle).~Cycle 2-6: Placebo was administered orally 2 time a day on Days 1 to 21 (21-day cycles) plus 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle."
10894698|NCT00538681|EG004|Reported Event|Part 2- Pemetrexed + Cisplatin|Participant was not randomized to Arm A or Arm B but received 500 mg/m² pemetrexed and 75 mg/m² cisplatin administered intravenously but not randomized
10894699|NCT00538733|BG000|Baseline|T-BiRD Therapy (All Patients)|All patients that enrolled on the study and received treatment with T-BiRD are included in this analysis.
10894700|NCT00538733|FG000|Participant Flow|T-BiRD Therapy (All Patients)|26 patients started the treatment phase. Per protocol, completion of the treatment phase was defined as removal from treatment due to progression, or to pursue an alternative treatment (either a stem cell transplant, or further consolidation chemotherapy in pursuit of a transplant).
10894701|NCT00538733|OG000|Outcome|T-BiRD Therapy (All Patients)|26 patients started the treatment phase. Per protocol, completion of the treatment phase was defined as removal from treatment due to progression, or to pursue an alternative treatment (either a stem cell transplant, or further consolidation chemotherapy in pursuit of a transplant). 25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.
10894702|NCT00538733|OG000|Outcome|T-BiRD Therapy (All Patients)|25 of the 26 patients enrolled onto the were assessed for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.
10894703|NCT00538733|OG000|Outcome|T-BiRD Therapy (All Patients)|All 26 patients that were enrolled onto the study were assessed for event free survival.
10894704|NCT00538733|OG000|Outcome|T-BiRD Therapy (All Patients)|25 of the 26 patients enrolled onto the were assessed for progression, as one patient expired prior to first response assessment and could not be included in the analysis.
10894705|NCT00538733|EG000|Reported Event|T-BiRD Therapy (All Patients)|All 26 patients that were enrolled onto the study were assessed for adverse events.
10894706|NCT00538759|BG000|Baseline|EBRT|"External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.~External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty"
10894707|NCT00538759|BG001|Baseline|Control|Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
10894708|NCT00538759|BG002|Baseline|Total|Total of all reporting groups
10894709|NCT00538759|FG000|Participant Flow|EBRT|"External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.~External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty"
10894710|NCT00538759|FG001|Participant Flow|Control|Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
10894711|NCT00538759|OG000|Outcome|EBRT|"External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.~External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty"
10894712|NCT00538759|OG001|Outcome|Control|"Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.~Sham Control"
10894713|NCT00538759|EG000|Reported Event|EBRT|"External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.~External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty"
10894714|NCT00538759|EG001|Reported Event|Control|Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
10894715|NCT00538785|BG000|Baseline|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
10894716|NCT00538785|BG001|Baseline|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
10894717|NCT00538785|BG002|Baseline|Total|Total of all reporting groups
10894718|NCT00538785|FG000|Participant Flow|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
10894719|NCT00538785|FG001|Participant Flow|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
10894720|NCT00538785|OG000|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
10894721|NCT00538785|OG001|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
10894722|NCT00538785|EG000|Reported Event|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
10894723|NCT00538785|EG001|Reported Event|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
10894724|NCT00538824|BG000|Baseline|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
10914785|NCT00632749|OG010|Outcome|240 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914786|NCT00632749|OG002|Outcome|30 mg BI 811283 + 20 mg Cytarabine- Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10894725|NCT00538824|FG000|Participant Flow|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
10894726|NCT00538824|OG000|Outcome|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
10894727|NCT00538824|EG000|Reported Event|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
10894728|NCT00538850|BG000|Baseline|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
10894729|NCT00538850|FG000|Participant Flow|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
10894730|NCT00538850|FG001|Participant Flow|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
10894731|NCT00538850|FG002|Participant Flow|Placebo - Double-blind|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
10894732|NCT00538850|OG000|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
10894733|NCT00538850|OG001|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
10894734|NCT00538850|EG000|Reported Event|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
10894735|NCT00538850|EG001|Reported Event|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
10894736|NCT00538863|BG000|Baseline|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
11090466|NCT01529346|BG002|Baseline|PF-05089771 1600 mg|Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
10894737|NCT00538863|FG000|Participant Flow|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
10894738|NCT00538863|OG000|Outcome|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
10894739|NCT00538863|OG001|Outcome|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
10894740|NCT00538863|EG000|Reported Event|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
10894741|NCT00538863|EG001|Reported Event|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
10894742|NCT00538902|BG000|Baseline|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
10894743|NCT00538902|BG001|Baseline|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
10894744|NCT00538902|BG002|Baseline|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
10894745|NCT00538902|BG003|Baseline|Total|Total of all reporting groups
10894746|NCT00538902|FG000|Participant Flow|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
10894747|NCT00538902|FG001|Participant Flow|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
10894748|NCT00538902|FG002|Participant Flow|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
10894749|NCT00538902|OG000|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
10894750|NCT00538902|OG001|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
10894751|NCT00538902|OG002|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
10894752|NCT00538902|OG000|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
10894753|NCT00538902|EG000|Reported Event|DB Phase - Placebo EOW|Placebo administered subcutaneously every other week during Double-Blind treatment.
10894754|NCT00538902|EG001|Reported Event|DB Phase - Adalimumab 40 mg EOW|Adalimumab 40 mg administered subcutaneously every other week during Double-Blind treatment.
10894755|NCT00538902|EG002|Reported Event|DB Phase - Adalimumab 80 mg EOW|Adalimumab 80 mg administered subcutaneously every other week during Double-Blind treatment.
10894756|NCT00538902|EG003|Reported Event|Any Adalimumab|Any adalimumab exposure during the entire study, whether from Double-Blind or Open-Label treatment.
10894757|NCT00538915|BG000|Baseline|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
10894758|NCT00538915|FG000|Participant Flow|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
10894759|NCT00538915|OG000|Outcome|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg administered intravenously every 3 or 4 weeks for approximately 1 year.
10894760|NCT00538915|EG000|Reported Event|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
10894761|NCT00539006|BG000|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
10894762|NCT00539006|BG001|Baseline|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
10894763|NCT00539006|BG002|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10894764|NCT00539006|BG003|Baseline|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
10894765|NCT00539006|BG004|Baseline|Total|Total of all reporting groups
10894766|NCT00539006|FG000|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
10894767|NCT00539006|FG001|Participant Flow|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
10894768|NCT00539006|FG002|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10894769|NCT00539006|FG003|Participant Flow|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
10894770|NCT00539006|OG000|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
10894771|NCT00539006|OG001|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10894772|NCT00539006|OG002|Outcome|Total|All participants on both arms preference.
10894773|NCT00539006|OG000|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
10894774|NCT00539006|OG001|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
10894775|NCT00539006|OG002|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10894776|NCT00539006|OG003|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
10894777|NCT00539006|OG000|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS)110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
10894778|NCT00539006|OG002|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
10894779|NCT00539006|OG000|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
10894780|NCT00539006|EG000|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
10894781|NCT00539006|EG001|Reported Event|Fluticason Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
10894782|NCT00539006|EG002|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
10894783|NCT00539006|EG003|Reported Event|Placebo - FP|Subjects who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
10894784|NCT00539032|BG000|Baseline|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
10894785|NCT00539032|BG001|Baseline|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
10894786|NCT00539032|BG002|Baseline|Total|Total of all reporting groups
10894787|NCT00539032|FG000|Participant Flow|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
10894788|NCT00539032|FG001|Participant Flow|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
10894789|NCT00539032|OG000|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
11233254|NCT02425098|EG000|Reported Event|High-dose Tetravalent Dengue Vaccine (HD-TDV)|High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
10894790|NCT00539032|OG001|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
10894791|NCT00539032|EG000|Reported Event|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
10894792|NCT00539032|EG001|Reported Event|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
10894793|NCT00539110|BG000|Baseline|Zolpidem First, Then Ramelteon|dosed at 2200 and 0200 per the feeding tube
10894794|NCT00539110|BG001|Baseline|Ramelteon First, Then Zolpidem|dosed at 2200 and 0200 per the feeding tube
10894795|NCT00539110|BG002|Baseline|Total|Total of all reporting groups
10894796|NCT00539110|FG000|Participant Flow|Zolpidem First, Then Ramelteon|"medication dosed at 2200 and 0200 per feeding tube~washout with no sleep meds (3 nights); zolpidem (x4 nights); washout (x3 nights); then ramelteon (x4 nights)"
10894797|NCT00539110|FG001|Participant Flow|Ramelteon, Then Zolpidem|"medication dosed at 2200 and 0200 per the feeding tube~washout with no sleep meds (x3 nights); ramelteon (x4 nights); washout (x3 nights); then zolpidem (x 4 nights)"
10894798|NCT00539110|OG000|Outcome|Zolpidem|medication dosed at 2200 and 0200 per feeding tube
10894799|NCT00539110|OG001|Outcome|Ramelteon|dosed at 2200 and 0200 per the feeding tube
10894800|NCT00539110|EG000|Reported Event|Zolpidem|"medication dosed at 2200 and 0200 per feeding tube~zolipidem: dosed at 2200 and 0200 per feeding tube"
10894801|NCT00539110|EG001|Reported Event|Ramelteon|"dosed at 2200 and 0200 per the feeding tube~ramelteon: medication dosed at 2200 and 0200 per feeding tube"
11233255|NCT02425098|EG001|Reported Event|Tetravalent Dengue Vaccine (TDV)|Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2*10^4 plaque forming units (PFU), 5*10^3 PFU, 1*10^5 PFU, and 3*10^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
10894802|NCT00539188|BG000|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
10894803|NCT00539188|BG001|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
10894804|NCT00539188|BG002|Baseline|Total|Total of all reporting groups
10894805|NCT00539188|FG000|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
10894806|NCT00539188|FG001|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
10894807|NCT00539188|OG000|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
10894808|NCT00539188|OG001|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
10894809|NCT00539188|EG000|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
10894810|NCT00539188|EG001|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
10894811|NCT00539240|BG000|Baseline|AciPhex 20 mg BID and Once Daily Placebo|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
10894812|NCT00539240|BG001|Baseline|AcipHex 20 mg Once Daily and BID Placebo|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
10894813|NCT00539240|BG002|Baseline|AcipHex 20 mg Once, Placebo Once, Nortriptyline|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
10894814|NCT00539240|BG003|Baseline|Total|Total of all reporting groups
10894815|NCT00539240|FG000|Participant Flow|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
10894816|NCT00539240|FG001|Participant Flow|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
10894817|NCT00539240|FG002|Participant Flow|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
10894818|NCT00539240|OG000|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
10894819|NCT00539240|OG001|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
10894820|NCT00539240|OG002|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
10894821|NCT00539240|EG000|Reported Event|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
10894822|NCT00539240|EG001|Reported Event|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
10894823|NCT00539240|EG002|Reported Event|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
10894824|NCT00539253|BG000|Baseline|Gadobenate Dimeglumine (Multi Hance)|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies."
10894825|NCT00539253|FG000|Participant Flow|Gadabenate Dimeglumine( Multihance)|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MRI imaging for both the baseline and 1 month f/u studies."
10894826|NCT00539253|OG000|Outcome|Multihance|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies."
10894827|NCT00539253|EG000|Reported Event|Gadobenate Dimeglumine (Multi Hance)|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies."
10894828|NCT00539279|BG000|Baseline|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
10894829|NCT00539279|BG001|Baseline|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
10894830|NCT00539279|BG002|Baseline|Total|Total of all reporting groups
10894831|NCT00539279|FG000|Participant Flow|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
10894832|NCT00539279|FG001|Participant Flow|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
10894833|NCT00539279|OG000|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
10894834|NCT00539279|OG001|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
10894835|NCT00539279|EG000|Reported Event|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
10894836|NCT00539279|EG001|Reported Event|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
10894837|NCT00539305|BG000|Baseline|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
10894838|NCT00539305|BG001|Baseline|Placebo Group|Placebo gel : applied topically daily for six months
10894839|NCT00539305|BG002|Baseline|Total|Total of all reporting groups
10894840|NCT00539305|FG000|Participant Flow|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
10894841|NCT00539305|FG001|Participant Flow|Placebo Group|Placebo gel : applied topically daily for six months
11233256|NCT02425111|BG000|Baseline|Vedolizumab 300 mg|Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
10894842|NCT00539305|OG000|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
10894843|NCT00539305|OG001|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
10894844|NCT00539305|EG000|Reported Event|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
10894845|NCT00539305|EG001|Reported Event|Placebo Group|Placebo gel : applied topically daily for six months
10894846|NCT00539500|BG000|Baseline|Transplantation CD133+ Cells|"Stem Cell Transplantation of CD133+ cells using the ClinicMACS in combination with Carboplatin + Etoposide + Melphalan~Carboplatin: Carboplatin by vein over 24 hours for 4 days, dosing as determined at day 1.~Etoposide: 300 mg/m^2 by vein over 24 hours for 4 days~Melphalan: 70 mg/m^2 Intravenous Bolus for 3 Days~Stem Cell Infusion: Stem Cell Infusion (approximately 5x10^8 TNC cells/kg CD133+ selected) on Day 0.~ClinicMACS: Device used to process the blood and separate the CD 133+ cells needed for transplantation"
10894847|NCT00539500|FG000|Participant Flow|Transplantation CD133+ Cells|"Stem Cell Transplantation of CD133+ cells using the ClinicMACS in combination with Carboplatin + Etoposide + Melphalan~Carboplatin: Carboplatin by vein over 24 hours for 4 days, dosing as determined at day 1.~Etoposide: 300 mg/m^2 by vein over 24 hours for 4 days~Melphalan: 70 mg/m^2 Intravenous Bolus for 3 Days~Stem Cell Infusion: Stem Cell Infusion (approximately 5x10^8 TNC cells/kg CD133+ selected) on Day 0.~ClinicMACS: Device used to process the blood and separate the CD 133+ cells needed for transplantation"
10894848|NCT00539500|OG000|Outcome|Transplantation CD133+ Cells|"Stem Cell Transplantation of CD133+ cells using the ClinicMACS in combination with Carboplatin + Etoposide + Melphalan~Carboplatin: Carboplatin by vein over 24 hours for 4 days, dosing as determined at day 1.~Etoposide: 300 mg/m^2 by vein over 24 hours for 4 days~Melphalan: 70 mg/m^2 Intravenous Bolus for 3 Days~Stem Cell Infusion: Stem Cell Infusion (approximately 5x10^8 TNC cells/kg CD133+ selected) on Day 0.~ClinicMACS: Device used to process the blood and separate the CD 133+ cells needed for transplantation"
10894849|NCT00539500|EG000|Reported Event|Transplantation CD133+ Cells|"Stem Cell Transplantation of CD133+ cells using the ClinicMACS in combination with Carboplatin + Etoposide + Melphalan~Carboplatin: Carboplatin by vein over 24 hours for 4 days, dosing as determined at day 1.~Etoposide: 300 mg/m^2 by vein over 24 hours for 4 days~Melphalan: 70 mg/m^2 Intravenous Bolus for 3 Days~Stem Cell Infusion: Stem Cell Infusion (approximately 5x10^8 TNC cells/kg CD133+ selected) on Day 0.~ClinicMACS: Device used to process the blood and separate the CD 133+ cells needed for transplantation"
10894850|NCT00539513|BG000|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
10894851|NCT00539513|BG001|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
10894852|NCT00539513|BG002|Baseline|Total|Total of all reporting groups
10894853|NCT00539513|FG000|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
10894854|NCT00539513|FG001|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
10894855|NCT00539513|OG000|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
10894856|NCT00539513|OG001|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
10894857|NCT00539513|EG000|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
10894858|NCT00539513|EG001|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
10894859|NCT00539526|BG000|Baseline|Bimatoprost 0.03%|bimatoprost 0.03%
10894860|NCT00539526|BG001|Baseline|Travoprost 0.004%|travoprost 0.004%
10894861|NCT00539526|BG002|Baseline|Latanoprost 0.005%|latanoprost 0.005%
10894862|NCT00539526|BG003|Baseline|Total|Total of all reporting groups
10894863|NCT00539526|FG000|Participant Flow|Bimatoprost 0.03%|bimatoprost 0.03%
10894864|NCT00539526|FG001|Participant Flow|Travoprost 0.004%|travoprost 0.004%
10894865|NCT00539526|FG002|Participant Flow|Latanoprost 0.005%|latanoprost 0.005%
10894866|NCT00539526|OG000|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
10894867|NCT00539526|OG001|Outcome|Travoprost 0.004%|travoprost 0.004%
10894868|NCT00539526|OG002|Outcome|Latanoprost 0.005%|latanoprost 0.005%
10894869|NCT00539526|EG000|Reported Event|Bimatoprost 0.03%|bimatoprost 0.03%
10894870|NCT00539526|EG001|Reported Event|Travoprost 0.004%|travoprost 0.004%
10894871|NCT00539526|EG002|Reported Event|Latanoprost 0.005%|latanoprost 0.005%
10894872|NCT00539539|BG000|Baseline|Feedback On|Automated real-time feedback on CPR Process activated
10914787|NCT00632749|OG005|Outcome|120mg (BI 811283+ Cytarabine)- Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10894873|NCT00539539|BG001|Baseline|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
10894874|NCT00539539|BG002|Baseline|Total|Total of all reporting groups
10894875|NCT00539539|FG000|Participant Flow|Feedback On|Automated real-time feedback on CPR Process activated
10894876|NCT00539539|FG001|Participant Flow|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
10894877|NCT00539539|OG000|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
10894878|NCT00539539|OG001|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
10894879|NCT00539539|EG000|Reported Event|Feedback On|Automated real-time feedback on CPR Process activated
10894880|NCT00539539|EG001|Reported Event|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
10894881|NCT00539656|BG000|Baseline|Single Arm|"Patients with a hematologic malignancy who are candidates for myeloablative allogeneic BMT but lack an available matched sibling or unrelated marrow donor are eligible for this study if they have two suitably matched cord blood products with an adequate (1 x 10e7 TNC/kg IBW) but suboptimal (<5 x 10e7 TNC/kg IBW) cell dose.~One cord blood unit is expanded beginning 14 days before graft infusion (6 or 7 days before the start of the preparative regimen). Patients receive a standard myeloablative preparative regimen. The expanded cord blood unit is infused on day 0 and the unmanipulated cord blood unit is expanded on day 1."
10894882|NCT00539656|FG000|Participant Flow|Single Arm|Patients with a hematologic malignancy who are candidates for myeloablative allogeneic BMT but lack an available matched sibling or unrelated marrow donor are eligible for this study if they have two suitably matched cord blood products with an adequate (1 x 10e7 TNC/kg IBW) but suboptimal (<5 x 10e7 TNC/kg IBW) cell dose. Eligible diagnoses include AML, MDS, ALL after failure of at least one regimen, mixed lineage leukemia, CML beyond first chronic phase, and lymphoma ineligible for autologous transplantation.
10894883|NCT00539656|OG000|Outcome|Receive Two Cord Blood Units|Ex vivo expansion of cord blood: Day 0: the expanded cell product will be infused to patient; Day +1: A second, unexpanded, cord blood product will be infused
10894884|NCT00539656|EG000|Reported Event|Single Arm|"Patients with a hematologic malignancy who are candidates for myeloablative allogeneic BMT but lack an available matched sibling or unrelated marrow donor are eligible for this study if they have two suitably matched cord blood products with an adequate (1 x 10e7 TNC/kg IBW) but suboptimal (<5 x 10e7 TNC/kg IBW) cell dose.~One cord blood unit is expanded beginning 14 days before graft infusion (6 or 7 days before the start of the preparative regimen). Patients receive a standard myeloablative preparative regimen. The expanded cord blood unit is infused on day 0 and the unmanipulated cord blood unit is expanded on day 1."
10894885|NCT00539695|BG000|Baseline|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as 'week beginning with first IL-2 injection."
10894886|NCT00539695|FG000|Participant Flow|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as 'week beginning with first IL-2 injection."
10914788|NCT00632749|OG008|Outcome|80 mg BI 811283 +20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11233257|NCT02425111|FG000|Participant Flow|Vedolizumab 300 mg|Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
10894887|NCT00539695|OG000|Outcome|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as 'week beginning with first IL-2 injection."
10894888|NCT00539695|EG000|Reported Event|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as 'week beginning with first IL-2 injection."
10894889|NCT00539734|BG000|Baseline|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
10894890|NCT00539734|FG000|Participant Flow|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
10894891|NCT00539734|OG000|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
10894892|NCT00539734|EG000|Reported Event|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
10894893|NCT00539864|BG000|Baseline|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
10894894|NCT00539864|BG001|Baseline|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
10894895|NCT00539864|BG002|Baseline|Total|Total of all reporting groups
10894896|NCT00539864|FG000|Participant Flow|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
10894897|NCT00539864|FG001|Participant Flow|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
10894898|NCT00539864|OG000|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
10894899|NCT00539864|OG001|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
10894900|NCT00539864|EG000|Reported Event|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
10894901|NCT00539864|EG001|Reported Event|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
10894902|NCT00539942|BG000|Baseline|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
10894903|NCT00539942|BG001|Baseline|Fondaparinux (Arixtra)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
10894904|NCT00539942|BG002|Baseline|Total|Total of all reporting groups
10894905|NCT00539942|FG000|Participant Flow|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
11233258|NCT02425111|OG000|Outcome|Vedolizumab 300 mg|Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
11233259|NCT02425111|EG000|Reported Event|Vedolizumab 300 mg Part A|Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22.
10894906|NCT00539942|FG001|Participant Flow|Arixtra (Fondaparinux Sodium)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
10894907|NCT00539942|OG000|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
10894908|NCT00539942|OG001|Outcome|Arixtra (Fondaparinux Sodium)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
10894909|NCT00539942|EG000|Reported Event|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
10894910|NCT00539942|EG001|Reported Event|Arixtra (Fondaparinux Sodium)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
10894911|NCT00539994|BG000|Baseline|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
10894912|NCT00539994|BG001|Baseline|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
11171541|NCT02004093|FG000|Participant Flow|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 milligrams (mg) intravenously (IV) on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/square meters (m^2) IV on Day 1 and carboplatin target area under the curve (AUC) 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
11171542|NCT02004093|FG001|Participant Flow|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
11171543|NCT02004093|OG000|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
10894913|NCT00539994|BG002|Baseline|Placebo|Placebo 200 mg BID for 5 days
10894914|NCT00539994|BG003|Baseline|Total|Total of all reporting groups
10894915|NCT00539994|FG000|Participant Flow|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
10894916|NCT00539994|FG001|Participant Flow|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
10894917|NCT00539994|FG002|Participant Flow|Placebo|Placebo 200 mg BID for 5 days
10894918|NCT00539994|OG000|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
10894919|NCT00539994|OG001|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
10894920|NCT00539994|OG000|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
10894921|NCT00539994|OG002|Outcome|Placebo|Placebo 200 mg BID for 5 days
10894922|NCT00539994|OG000|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 Days and Placebo 2 days
10894923|NCT00539994|OG003|Outcome|Total|Total of all Groups
10894924|NCT00539994|OG000|Outcome|Positive Nasal Culture for S. Aureus|Screened subjects positive for S. aureus
10894925|NCT00539994|OG001|Outcome|Positive Pharyngeal Culture for S. Aureus|Subjects who tested positive for S. aureus in the pharyngeal region.
10894926|NCT00539994|OG000|Outcome|MRSA|Methicillin Resistant S. aureus.
10894927|NCT00539994|OG003|Outcome|Total|Total of all groups
10894928|NCT00539994|EG000|Reported Event|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
10894929|NCT00539994|EG001|Reported Event|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
10894930|NCT00539994|EG002|Reported Event|Placebo|Placebo 200 mg BID for 5 days
10894931|NCT00540007|BG000|Baseline|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
10894932|NCT00540007|BG001|Baseline|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
10894933|NCT00540007|BG002|Baseline|Total|Total of all reporting groups
10894934|NCT00540007|FG000|Participant Flow|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
11171544|NCT02004093|OG001|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
10894935|NCT00540007|FG001|Participant Flow|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
10894936|NCT00540007|OG000|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
10894937|NCT00540007|OG001|Outcome|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
10894938|NCT00540007|OG001|Outcome|Cohort 2|Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
10894939|NCT00540007|EG000|Reported Event|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
10894940|NCT00540007|EG001|Reported Event|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
10894941|NCT00540046|BG000|Baseline|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
10894942|NCT00540046|BG001|Baseline|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
10894943|NCT00540046|BG002|Baseline|Total|Total of all reporting groups
11233260|NCT02425111|EG001|Reported Event|Vedolizumab 300 mg Part B|Following Part A, Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
11233261|NCT02425449|BG000|Baseline|Arm 1|"0.1 mg/kg of succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10894944|NCT00540046|FG000|Participant Flow|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
10894945|NCT00540046|FG001|Participant Flow|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
10894946|NCT00540046|OG000|Outcome|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
10894947|NCT00540046|OG001|Outcome|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
10894948|NCT00540046|OG000|Outcome|A/Immediate|"The patients in the immediate arm had the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure.~IUD status was known six months post-abortion and insertion."
10894949|NCT00540046|OG001|Outcome|B/Delayed|"The delayed group had the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~IUD status was known six months post-abortion."
10894950|NCT00540046|EG000|Reported Event|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
10894951|NCT00540046|EG001|Reported Event|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
10894952|NCT00540124|BG000|Baseline|Placebo|by mouth once a day
10894953|NCT00540124|BG001|Baseline|Tadalafil|5 mg by mouth once a day
10894954|NCT00540124|BG002|Baseline|Tamsulosin|0.2 mg by mouth once a day
10894955|NCT00540124|BG003|Baseline|Total|Total of all reporting groups
10894956|NCT00540124|FG000|Participant Flow|Placebo|by mouth once a day
10894957|NCT00540124|FG001|Participant Flow|Tadalafil|5 mg by mouth once a day
10894958|NCT00540124|FG002|Participant Flow|Tamsulosin|0.2 mg by mouth once a day
10894959|NCT00540124|OG000|Outcome|Placebo|by mouth once a day
10894960|NCT00540124|OG001|Outcome|Tadalafil|5 mg by mouth once a day
10894961|NCT00540124|OG002|Outcome|Tamsulosin|0.2 mg by mouth once a day
10894962|NCT00540124|EG000|Reported Event|Placebo|by mouth once a day
10894963|NCT00540124|EG001|Reported Event|Tadalafil|5 mg by mouth once a day
10894964|NCT00540124|EG002|Reported Event|Tamsulosin|0.2 mg by mouth once a day
10894965|NCT00540228|BG000|Baseline|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894966|NCT00540228|BG001|Baseline|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894967|NCT00540228|BG002|Baseline|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
11233262|NCT02425449|BG001|Baseline|Arm 2|"0.15 mg/kg of succinycholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10894968|NCT00540228|BG003|Baseline|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894969|NCT00540228|BG004|Baseline|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894970|NCT00540228|BG005|Baseline|Total|Total of all reporting groups
10894971|NCT00540228|FG000|Participant Flow|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894972|NCT00540228|FG001|Participant Flow|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894973|NCT00540228|FG002|Participant Flow|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894974|NCT00540228|FG003|Participant Flow|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894975|NCT00540228|FG004|Participant Flow|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894976|NCT00540228|OG000|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894977|NCT00540228|OG001|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894978|NCT00540228|OG002|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894979|NCT00540228|OG003|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894980|NCT00540228|OG004|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894981|NCT00540228|EG000|Reported Event|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894982|NCT00540228|EG001|Reported Event|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894983|NCT00540228|EG002|Reported Event|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894984|NCT00540228|EG003|Reported Event|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894985|NCT00540228|EG004|Reported Event|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10894986|NCT00540293|BG000|Baseline|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
10894987|NCT00540293|FG000|Participant Flow|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
10894988|NCT00540293|OG000|Outcome|Total|N=425 (Total=sum of all risk groups)
10894989|NCT00540293|OG001|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
10894990|NCT00540293|OG002|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
10894991|NCT00540293|OG003|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
10894992|NCT00540293|OG002|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
10894993|NCT00540293|OG001|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
10894994|NCT00540293|OG000|Outcome|Total|N=425 (Total: sum of all risk groups)
10894995|NCT00540293|EG000|Reported Event|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
10894996|NCT00540423|BG000|Baseline|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
10894997|NCT00540423|BG001|Baseline|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
10894998|NCT00540423|BG002|Baseline|Total|Total of all reporting groups
10894999|NCT00540423|FG000|Participant Flow|Placebo|Placebo 12.5 milligrams (mg) for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7
10895000|NCT00540423|FG001|Participant Flow|SB-497115-GR, Double-blind|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7.
10895001|NCT00540423|FG002|Participant Flow|SB-497115-GR, Open-label|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count.
10895002|NCT00540423|OG000|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
10895003|NCT00540423|OG001|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
10895004|NCT00540423|OG000|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
10895005|NCT00540423|OG000|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
10895006|NCT00540423|OG001|Outcome|SG-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
10895007|NCT00540423|OG000|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
10895008|NCT00540423|OG001|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
10895009|NCT00540423|OG002|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
10895010|NCT00540423|OG001|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
10895011|NCT00540423|OG000|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
10895012|NCT00540423|OG002|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
10895013|NCT00540423|OG001|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB497511-GR on the PK sampling day
10895014|NCT00540423|OG002|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB497511-GR on the PK sampling day
10895015|NCT00540423|EG000|Reported Event|Placebo Short-Term (Double-Blind) Phase|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
10895016|NCT00540423|EG001|Reported Event|SB-497115-GR Short-Term (Double-Blind) Phase|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
10895017|NCT00540423|EG002|Reported Event|SB-497115-GR Long-Term Phase|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received up to 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count
10895018|NCT00540436|BG000|Baseline|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
10895019|NCT00540436|FG000|Participant Flow|GSK1325760A|First Treatment Period: GSK1325760A 5 mg once a day. Second Treatment Period: GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
10895020|NCT00540436|OG000|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
10895021|NCT00540436|EG000|Reported Event|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
10895022|NCT00540449|BG000|Baseline|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
10895023|NCT00540449|BG001|Baseline|Efavirenz|600 mg once daily for 96 weeks.
10895024|NCT00540449|BG002|Baseline|Total|Total of all reporting groups
10895025|NCT00540449|FG000|Participant Flow|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
11233263|NCT02425449|BG002|Baseline|Arm 3|"0.2 mg/kg of succinylcholne arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895026|NCT00540449|FG001|Participant Flow|Efavirenz|600 mg once daily for 96 weeks.
10895027|NCT00540449|OG000|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
10895028|NCT00540449|OG001|Outcome|Efavirenz|600 mg once daily for 96 weeks.
10895029|NCT00540449|EG000|Reported Event|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
10895030|NCT00540449|EG001|Reported Event|Efavirenz|600 mg once daily for 96 weeks.
10895031|NCT00540514|BG000|Baseline|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895032|NCT00540514|BG001|Baseline|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895033|NCT00540514|BG002|Baseline|Total|Total of all reporting groups
10895034|NCT00540514|FG000|Participant Flow|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895035|NCT00540514|FG001|Participant Flow|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895036|NCT00540514|OG000|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895037|NCT00540514|OG001|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895038|NCT00540514|OG000|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895039|NCT00540514|EG000|Reported Event|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895040|NCT00540514|EG001|Reported Event|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
10895041|NCT00540579|BG000|Baseline|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
11171545|NCT02004093|OG000|Outcome|Chemotherapy + Pertuzumab|Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off
11171546|NCT02004093|OG000|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
11171547|NCT02004093|OG000|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen17 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
10895042|NCT00540579|FG000|Participant Flow|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
10895043|NCT00540579|OG000|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
10895044|NCT00540579|EG000|Reported Event|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
10895045|NCT00540592|BG000|Baseline|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
10895046|NCT00540592|BG001|Baseline|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
11171548|NCT02004093|EG000|Reported Event|Chemotherapy + Pertuzumab|Participants received loading dose of 840mg IV Pertuzumab, followed by 420 mg IV every 3 weeks (for a total of 17 cycles), along with chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles, followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
11233264|NCT02425449|BG003|Baseline|Arm 4|"0.25 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895047|NCT00540592|BG002|Baseline|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
10895048|NCT00540592|BG003|Baseline|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
10895049|NCT00540592|BG004|Baseline|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
10895050|NCT00540592|BG005|Baseline|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
10895051|NCT00540592|BG006|Baseline|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
10895052|NCT00540592|BG007|Baseline|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
10895053|NCT00540592|BG008|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
10895054|NCT00540592|BG009|Baseline|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
10895055|NCT00540592|BG010|Baseline|Total|Total of all reporting groups
10895056|NCT00540592|FG000|Participant Flow|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
10895057|NCT00540592|FG001|Participant Flow|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
10895058|NCT00540592|FG002|Participant Flow|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
10895059|NCT00540592|FG003|Participant Flow|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
10895060|NCT00540592|FG004|Participant Flow|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
10895061|NCT00540592|FG005|Participant Flow|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
10895062|NCT00540592|FG006|Participant Flow|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
10895063|NCT00540592|FG007|Participant Flow|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
10895064|NCT00540592|FG008|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
10895065|NCT00540592|FG009|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
10895066|NCT00540592|OG000|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
10895067|NCT00540592|OG001|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
10895068|NCT00540592|OG002|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
10895069|NCT00540592|OG003|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
10895070|NCT00540592|OG004|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
10895071|NCT00540592|OG005|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
10895072|NCT00540592|OG006|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
10895073|NCT00540592|OG007|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
10895074|NCT00540592|OG008|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
10895075|NCT00540592|OG009|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
10895076|NCT00540592|EG000|Reported Event|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
10895077|NCT00540592|EG001|Reported Event|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
10895078|NCT00540592|EG002|Reported Event|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
10895079|NCT00540592|EG003|Reported Event|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
10895080|NCT00540592|EG004|Reported Event|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
10895081|NCT00540592|EG005|Reported Event|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
10895082|NCT00540592|EG006|Reported Event|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
10895083|NCT00540592|EG007|Reported Event|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
10895084|NCT00540592|EG008|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
10895085|NCT00540592|EG009|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
10895086|NCT00540644|BG000|Baseline|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
10895087|NCT00540644|BG001|Baseline|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
10895088|NCT00540644|BG002|Baseline|Total|Total of all reporting groups
10895089|NCT00540644|FG000|Participant Flow|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
10895090|NCT00540644|FG001|Participant Flow|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
10895091|NCT00540644|OG000|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
10895092|NCT00540644|OG001|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
10895093|NCT00540644|EG000|Reported Event|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
10895094|NCT00540644|EG001|Reported Event|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
10895095|NCT00540722|BG000|Baseline|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
10895096|NCT00540722|FG000|Participant Flow|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
10895097|NCT00540722|OG000|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
10895098|NCT00540722|OG000|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
10895099|NCT00540722|EG000|Reported Event|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
11171549|NCT02004093|EG001|Reported Event|Chemotherapy|Participants received chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/ m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
11171550|NCT02004132|BG000|Baseline|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
11233265|NCT02425449|BG004|Baseline|Arm 5|"0.3 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
11233266|NCT02425449|BG005|Baseline|Total|Total of all reporting groups
10895100|NCT00540982|BG000|Baseline|All Patients|All patients with treatment-refractory solid tumors enrolled on the study.
10895101|NCT00540982|FG000|Participant Flow|All Patients|All patients with treatment-refractory solid tumors enrolled on the study.
10895102|NCT00540982|OG000|Outcome|Normal|"Patients were administered weekly 30mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum).~Normal liver function was defined as bilirubin <1.5 mg/dL"
10895103|NCT00540982|OG001|Outcome|Mild|"Patients were administered weekly 30mg/m2, 20mg/m2 or 15mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum).~Mild liver dysfunction defined as bilirubin <1.5 mg/dL and ≥1 of the following: AST/ALT 1.5-2.5 X ULN or ALK 1.5-3 X ULN"
10895104|NCT00540982|OG002|Outcome|Moderate|"Patients were administered weekly 30mg/m2 or 15mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum).~Moderate liver dysfunction was defined as bilirubin 1.5-3.0 mg/dL and/or ≥1 of the following: AST/ALT >2.5 X ULN or ALK >3 X ULN."
10895105|NCT00540982|OG003|Outcome|Severe|"Patients were administered weekly 20mg/m2 or 7.5mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum).~Severe liver dysfunction was defined as bilirubin >3.0 mg/dL."
10895106|NCT00540982|OG000|Outcome|Normal (30mg/m2)|Normal Liver Function Group with 30 mg/m2 of Vinorelbine.
10895107|NCT00540982|OG001|Outcome|Mild (30mg/m2)|Mild Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.
10895108|NCT00540982|OG002|Outcome|Mild (20mg/m2)|Mild Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.
10895109|NCT00540982|OG003|Outcome|Mild (15mg/m2)|Mild Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.
10895110|NCT00540982|OG004|Outcome|Moderate (30mg/m2)|Moderate Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.
10895111|NCT00540982|OG005|Outcome|Moderate (15mg/m2)|Moderate Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.
10895112|NCT00540982|OG006|Outcome|Severe (20mg/m2)|Severe Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.
10895113|NCT00540982|OG007|Outcome|Severe (7.5mg/m2)|Severe Liver Dysfunction Group with 7.5 mg/m2 of Vinorelbine.
10895114|NCT00540982|EG000|Reported Event|Normal (30mg/m2)|Normal Liver Function Group with 30 mg/m2 of Vinorelbine.
11233267|NCT02425449|FG000|Participant Flow|Arm 1|"0.1 mg/kg of succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
11233268|NCT02425449|FG001|Participant Flow|Arm 2|"0.15 mg/kg of succinycholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895115|NCT00540982|EG001|Reported Event|Mild (30mg/m2)|Mild Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.
10895116|NCT00540982|EG002|Reported Event|Mild (20mg/m2)|Mild Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.
10895117|NCT00540982|EG003|Reported Event|Mild (15mg/m2)|Mild Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.
10895118|NCT00540982|EG004|Reported Event|Moderate (30mg/m2)|Moderate Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.
10895119|NCT00540982|EG005|Reported Event|Moderate (15mg/m2)|Moderate Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.
10895120|NCT00540982|EG006|Reported Event|Severe (20mg/m2)|Severe Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.
10895121|NCT00540982|EG007|Reported Event|Severe (7.5mg/m2)|Severe Liver Dysfunction Group with 7.5 mg/m2 of Vinorelbine.
10895122|NCT00541034|BG000|Baseline|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
10895123|NCT00541034|FG000|Participant Flow|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
10895124|NCT00541034|OG000|Outcome|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
10895125|NCT00541034|EG000|Reported Event|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
10895126|NCT00541099|BG000|Baseline|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
10895127|NCT00541099|FG000|Participant Flow|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
10895128|NCT00541099|OG000|Outcome|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
10895129|NCT00541099|EG000|Reported Event|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
10895130|NCT00541190|BG000|Baseline|Cystic Fibrosis|Cystic fibrosis patients
10895131|NCT00541190|BG001|Baseline|Healthy Controls|Healthy subjects.
10895132|NCT00541190|BG002|Baseline|Total|Total of all reporting groups
10895133|NCT00541190|FG000|Participant Flow|Cystic Fibrosis|Cystic fibrosis patients
10895134|NCT00541190|FG001|Participant Flow|Healthy Controls|Healthy subjects.
10895135|NCT00541190|OG000|Outcome|Cystic Fibrosis|Cystic fibrosis patients - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
10895136|NCT00541190|OG001|Outcome|Healthy Controls|Healthy subjects without lung disease - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
10895137|NCT00541190|OG000|Outcome|Cystic Fibrosis|Cystic fibrosis patients
10895138|NCT00541190|OG001|Outcome|Healthy Controls|Healthy subjects.
10895139|NCT00541190|EG000|Reported Event|Cystic Fibrosis|Cystic fibrosis patients
10895140|NCT00541190|EG001|Reported Event|Healthy Controls|Healthy subjects.
10895141|NCT00541229|BG000|Baseline|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
10895142|NCT00541229|BG001|Baseline|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
10895143|NCT00541229|BG002|Baseline|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
10895144|NCT00541229|BG003|Baseline|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
10895145|NCT00541229|BG004|Baseline|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
10895146|NCT00541229|BG005|Baseline|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
11171551|NCT02004132|FG000|Participant Flow|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
11171552|NCT02004132|OG000|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
10895147|NCT00541229|BG006|Baseline|Total|Total of all reporting groups
10895148|NCT00541229|FG000|Participant Flow|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
10895149|NCT00541229|FG001|Participant Flow|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
10895150|NCT00541229|FG002|Participant Flow|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
10895151|NCT00541229|FG003|Participant Flow|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
10895152|NCT00541229|FG004|Participant Flow|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
10895153|NCT00541229|FG005|Participant Flow|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
10895154|NCT00541229|OG000|Outcome|Sitagliptin 200mg|Sitagliptin 200 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 200 mg/Sitagliptin 100 mg/placebo and treatment sequence Sitagliptin 200 mg/ placebo/ Sitagliptin 100 mg.
10895155|NCT00541229|OG001|Outcome|Sitagliptin 100mg|Sitagliptin 100 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 100 mg/Sitagliptin 200 mg/placebo and treatment sequence Sitagliptin 100 mg/ placebo/ Sitagliptin 200 mg.
10895156|NCT00541229|OG002|Outcome|Placebo|Placebo group included the Treatment Period I data from patients randomized to treatment sequence placebo/Sitagliptin 100 mg/Sitagliptin 200 mg and treatment sequence placebo/Sitagliptin 200 mg/Sitagliptin 100 mg.
11171553|NCT02004132|EG000|Reported Event|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
11171554|NCT02004158|BG000|Baseline|Positive Psychology|Positive psychology intervention
11171555|NCT02004158|FG000|Participant Flow|Positive Psychology|Positive psychology intervention
11171556|NCT02004158|OG000|Outcome|Positive Psychology|Positive psychology intervention
11171557|NCT02004158|OG000|Outcome|Positive Psychology|Positive psychology intervention (Baseline data)
11171558|NCT02004158|OG001|Outcome|Positive Psychology|Positive psychology intervention (8 week data)
10895157|NCT00541229|EG000|Reported Event|Sitagliptin 200 mg|Sitagliptin 200 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 200 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
10895158|NCT00541229|EG001|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 100 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
10895159|NCT00541229|EG002|Reported Event|Placebo|Placebo Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin-matching placebo tablets. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
10895160|NCT00541242|BG000|Baseline|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
10895161|NCT00541242|BG001|Baseline|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
10895162|NCT00541242|BG002|Baseline|Total|Total of all reporting groups
10895163|NCT00541242|FG000|Participant Flow|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
10895164|NCT00541242|FG001|Participant Flow|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
10895165|NCT00541242|OG000|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
10895166|NCT00541242|OG001|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
10895167|NCT00541242|EG000|Reported Event|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
10895168|NCT00541242|EG001|Reported Event|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
10895169|NCT00541307|BG000|Baseline|Enrolled Subjects|The total number of enrolled subjects.
10895170|NCT00541307|FG000|Participant Flow|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
10895171|NCT00541307|OG000|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
10895172|NCT00541307|EG000|Reported Event|Gore VIABAHN Endoprosthesis With Heparin Bioactive Surface|Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
10895173|NCT00541346|BG000|Baseline|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
10895174|NCT00541346|FG000|Participant Flow|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
10895175|NCT00541346|OG000|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
10895176|NCT00541346|EG000|Reported Event|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
10895177|NCT00541385|BG000|Baseline|PA Group|"Oral pyronaridine/artesunate (PA, 60:20mg granules) once a day for 3 consecutive days (Days 0, 1, and 2).~Posology based on body weight ranges."
10895178|NCT00541385|BG001|Baseline|AL Group|"Oral artemether/lumefantrine (AL, 20:120mg crushed tablets) twice a day for 3 consecutive days (Days 0, 1, and 2).~Posology based on body weight ranges."
10895179|NCT00541385|BG002|Baseline|Total|Total of all reporting groups
10895180|NCT00541385|FG000|Participant Flow|PA Group|"Oral pyronaridine/artesunate (PA, 60:20mg granules) once a day for 3 consecutive days (Days 0, 1, and 2).~Posology based on body weight ranges."
10895181|NCT00541385|FG001|Participant Flow|AL Group|"Oral artemether/lumefantrine (AL, 20:120mg crushed tablets) twice a day for 3 consecutive days (Days 0, 1, and 2).~Posology based on body weight ranges."
10895182|NCT00541385|OG000|Outcome|PA Group|"Oral pyronaridine/artesunate (PA, 60:20mg granules) once a day for 3 consecutive days (Days 0, 1, and 2).~Posology based on body weight ranges."
10895183|NCT00541385|OG001|Outcome|AL Group|"Oral artemether/lumefantrine (AL, 20:120mg crushed tablets) twice a day for 3 consecutive days (Days 0, 1, and 2).~Posology based on body weight ranges."
10895184|NCT00541385|EG000|Reported Event|PA Group|"Oral pyronaridine/artesunate (PA, 60:20mg granules) once a day for 3 consecutive days (Days 0, 1, and 2).~Posology was based on body weight ranges. Subjects were randomized in a 2:1 ratio to receive either PA or AL."
10895185|NCT00541385|EG001|Reported Event|AL Group|"Oral artemether/lumefantrine (AL, 20:120mg crushed tablets) twice a day for 3 consecutive days (Days 0, 1, and 2).~Posology was based on body weight ranges. Subjects were randomized in a 2:1 ratio to receive either PA or AL."
10895186|NCT00541450|BG000|Baseline|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
10895187|NCT00541450|BG001|Baseline|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
10895188|NCT00541450|BG002|Baseline|Total|Total of all reporting groups
10895189|NCT00541450|FG000|Participant Flow|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
11171559|NCT02004158|EG000|Reported Event|Positive Psychology|Positive psychology intervention
10895190|NCT00541450|FG001|Participant Flow|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
10895191|NCT00541450|OG000|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
10895192|NCT00541450|OG001|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
10895193|NCT00541450|OG000|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
10895194|NCT00541450|OG001|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
10895195|NCT00541450|EG000|Reported Event|Sitagliptin (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.
10895196|NCT00541450|EG001|Reported Event|Pioglitazone (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, all participants were up-titrated to 30 mg q.d. pioglitazone.
10895197|NCT00541450|EG002|Reported Event|Sita/Met FDC (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.~In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg b.i.d., which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
10895198|NCT00541450|EG003|Reported Event|Pioglitazone (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg q.d.~In Phase B (Treatment Week 12 -Week 40), participants were administered 45 mg q.d."
10895199|NCT00541593|BG000|Baseline|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
10895200|NCT00541593|FG000|Participant Flow|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
10895201|NCT00541593|OG000|Outcome|NOTES Pancreatic Pseudocystgastrostomy Patients|Pancreatic Pseudocystgastrostomy Patients having NOTES procedure
10895202|NCT00541593|EG000|Reported Event|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
10895203|NCT00541658|BG000|Baseline|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
10895204|NCT00541658|BG001|Baseline|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
10895205|NCT00541658|BG002|Baseline|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
10895206|NCT00541658|BG003|Baseline|Total|Total of all reporting groups
11090467|NCT01529346|BG003|Baseline|Ibuprofen|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11233269|NCT02425449|FG002|Participant Flow|Arm 3|"0.2 mg/kg of succinylcholne arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895207|NCT00541658|FG000|Participant Flow|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
10895208|NCT00541658|FG001|Participant Flow|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
11233270|NCT02425449|FG003|Participant Flow|Arm 4|"0.25 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
11233271|NCT02425449|FG004|Participant Flow|Arm 5|"0.3 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
11233272|NCT02425449|OG000|Outcome|Arm 1|"0.1 mg/kg of succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895209|NCT00541658|FG002|Participant Flow|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
10895210|NCT00541658|OG000|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
10895211|NCT00541658|OG001|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
10895212|NCT00541658|OG002|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
10895213|NCT00541658|OG000|Outcome|5 mg IRBB|5 mg immediate-release risedronate tablet daily, at least 30 minutes before breakfast for two years
10895214|NCT00541658|OG001|Outcome|35 mg DRFB + DRBB|Combined two arms - 35 mg delayed-release following breakfast (DRFB) with 35 mg delayed-relase before breakfast (DRBB)
10895215|NCT00541658|EG000|Reported Event|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
10895216|NCT00541658|EG001|Reported Event|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
10895217|NCT00541658|EG002|Reported Event|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
10895218|NCT00541671|BG000|Baseline|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
10895219|NCT00541671|BG001|Baseline|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
11090468|NCT01529346|BG004|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
10895220|NCT00541671|BG002|Baseline|Total|Total of all reporting groups
10895221|NCT00541671|FG000|Participant Flow|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
10895222|NCT00541671|FG001|Participant Flow|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
10895223|NCT00541671|OG000|Outcome|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
10895224|NCT00541671|OG001|Outcome|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
10895225|NCT00541671|EG000|Reported Event|Placebo|
10895226|NCT00541671|EG001|Reported Event|Promethazine|
10895227|NCT00541775|BG000|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
10895228|NCT00541775|BG001|Baseline|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
10895229|NCT00541775|BG002|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
10895230|NCT00541775|BG003|Baseline|Total|Total of all reporting groups
10895231|NCT00541775|FG000|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
10895232|NCT00541775|FG001|Participant Flow|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
10895233|NCT00541775|FG002|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
10895234|NCT00541775|OG000|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
10895235|NCT00541775|OG001|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
10895236|NCT00541775|OG002|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
10895237|NCT00541775|EG000|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
10895238|NCT00541775|EG001|Reported Event|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
10895239|NCT00541775|EG002|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
10895240|NCT00541866|BG000|Baseline|Group 1 (Sch A, 10 to 90 mg/m2)|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895241|NCT00541866|BG001|Baseline|Group 2 (Sch B, 70 to 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
11090469|NCT01529346|BG005|Baseline|Total|Total of all reporting groups
10895242|NCT00541866|BG002|Baseline|Group 3 (Sch A, First Relapse, 80 mg/m2):|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895243|NCT00541866|BG003|Baseline|Group 4 (Sch B, First Relapse, 90 mg/m2)|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895244|NCT00541866|BG004|Baseline|Group 5 (Sch B, Primary Refractory, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895245|NCT00541866|BG005|Baseline|Total|Total of all reporting groups
10895246|NCT00541866|FG000|Participant Flow|Group 1 (Sch A, 10 to 90 mg/m2)|Dose Escalation Phase Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895247|NCT00541866|FG001|Participant Flow|Group 2 (Sch B, 70 to 90 mg/m2):|Dose Escalation Phase Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895248|NCT00541866|FG002|Participant Flow|Group 3 (Sch A, First Relapse, 80 mg/m2)|Expansion Phase: Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)
10895249|NCT00541866|FG003|Participant Flow|Group 4 (Sch B, First Relapse, 90 mg/m2)|Expansion Phase: Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
10895250|NCT00541866|FG004|Participant Flow|Group 5 (Sch B, Primary Refractory, 90 mg/m2)|Expansion Phase Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
10895251|NCT00541866|OG000|Outcome|Sch A, Cohort 10mg/m2|Vosaroxin injection 10 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895252|NCT00541866|OG001|Outcome|Sch A, Cohort 20mg/m2|Vosaroxin injection 20 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895253|NCT00541866|OG002|Outcome|SchA, Cohort 34mg/m2|Vosaroxin injection 34 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895254|NCT00541866|OG003|Outcome|Sch A, Cohort 50mg/m2|Vosaroxin injection 50 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895255|NCT00541866|OG004|Outcome|Sch A, Cohort 70mg/m2|Vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895256|NCT00541866|OG005|Outcome|Sch A, Cohort 80mg/m2|Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895257|NCT00541866|OG006|Outcome|Sch A, Cohort 90mg/m2|Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895258|NCT00541866|OG007|Outcome|Sch B, Cohort 70 mg/m2|Schedule B: vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days).
10895259|NCT00541866|OG008|Outcome|Sch B, Cohort 80mg/m2|Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895260|NCT00541866|OG009|Outcome|Sch B, Cohort 90mg/m2|Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895261|NCT00541866|OG000|Outcome|Group 1 (Sch A, 10 to 90 mg/m2)|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895262|NCT00541866|OG001|Outcome|Group 2 (Sch B, 70 to 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895263|NCT00541866|OG002|Outcome|Group 3 (Sch A, First Relapse, 80 mg/m2):|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895264|NCT00541866|OG003|Outcome|Group 4 (Sch B, First Relapse, 90 mg/m2)|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895265|NCT00541866|OG004|Outcome|Group 5 (Sch B, Primary Refractory, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895266|NCT00541866|OG005|Outcome|Total|5 groups combined
10895267|NCT00541866|OG000|Outcome|Group 1 (Sch A, 10 to 90 mg/m2)|Dose Escalation Phase Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895268|NCT00541866|OG001|Outcome|Group 2 (Sch B, 70 to 90 mg/m2):|Dose Escalation Phase Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895269|NCT00541866|OG002|Outcome|Group 3 (Sch A, First Relapse, 80 mg/m2)|Expansion Phase: Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)
10895270|NCT00541866|OG003|Outcome|Group 4 (Sch B, First Relapse, 90 mg/m2)|Expansion Phase: Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
10895271|NCT00541866|OG004|Outcome|Group 5 (Sch B, Primary Refractory, 90 mg/m2)|Expansion Phase Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
10895272|NCT00541866|EG000|Reported Event|Group 1 (Sch A, 10 to 90 mg/m2):|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895273|NCT00541866|EG001|Reported Event|Group 2 (Sch B, 70 to 90 mg/m2):|saroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895274|NCT00541866|EG002|Reported Event|Group 3 (Sch A, First Relapse, 80 mg/m2)|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
10895275|NCT00541866|EG003|Reported Event|Group 4 (Sch B, First Relapse, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895276|NCT00541866|EG004|Reported Event|Group 5 (Sch B, Primary Refractory, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
10895277|NCT00541931|BG000|Baseline|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano: Daily use"
10895278|NCT00541931|BG001|Baseline|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano: Daily use"
10895279|NCT00541931|BG002|Baseline|Total|Total of all reporting groups
10895280|NCT00541931|FG000|Participant Flow|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
10895281|NCT00541931|FG001|Participant Flow|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
10895282|NCT00541931|OG000|Outcome|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
10895283|NCT00541931|OG001|Outcome|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
10895284|NCT00541931|OG000|Outcome|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano: Daily use"
10895285|NCT00541931|OG001|Outcome|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano: Daily use"
10895286|NCT00541931|EG000|Reported Event|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
10895287|NCT00541931|EG001|Reported Event|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
10895288|NCT00541970|BG000|Baseline|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895289|NCT00541970|BG001|Baseline|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
11171560|NCT02004236|BG000|Baseline|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
10895290|NCT00541970|BG002|Baseline|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895291|NCT00541970|BG003|Baseline|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
10895292|NCT00541970|BG004|Baseline|Total|Total of all reporting groups
10895293|NCT00541970|FG000|Participant Flow|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895294|NCT00541970|FG001|Participant Flow|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895295|NCT00541970|FG002|Participant Flow|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895296|NCT00541970|FG003|Participant Flow|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
10895297|NCT00541970|OG000|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895298|NCT00541970|OG001|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895299|NCT00541970|OG002|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895300|NCT00541970|OG003|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
11171561|NCT02004236|BG001|Baseline|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
11171562|NCT02004236|BG002|Baseline|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
11171563|NCT02004236|BG003|Baseline|Total|Total of all reporting groups
11171564|NCT02004236|FG000|Participant Flow|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
10895301|NCT00541970|EG000|Reported Event|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895302|NCT00541970|EG001|Reported Event|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895303|NCT00541970|EG002|Reported Event|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
10895304|NCT00541970|EG003|Reported Event|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
10895305|NCT00542178|BG000|Baseline|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
10895306|NCT00542178|BG001|Baseline|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
10895307|NCT00542178|BG002|Baseline|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
10895308|NCT00542178|BG003|Baseline|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
10895309|NCT00542178|BG004|Baseline|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
10895310|NCT00542178|BG005|Baseline|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
11171565|NCT02004236|FG001|Participant Flow|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
10895311|NCT00542178|BG006|Baseline|Total|Total of all reporting groups
10895312|NCT00542178|FG000|Participant Flow|Intensive Glycemia Control & Intensive Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
10895313|NCT00542178|FG001|Participant Flow|Standard Glycemia Control & Intensive Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
10895314|NCT00542178|FG002|Participant Flow|Intensive Glycemia Control & Standard Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
10895315|NCT00542178|FG003|Participant Flow|Standard Glycemia Control & Standard Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
10895316|NCT00542178|FG004|Participant Flow|Intensive Glycemia Control & Fibrate|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
10895317|NCT00542178|FG005|Participant Flow|Standard Glycemia Control & Fibrate|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
10895318|NCT00542178|FG006|Participant Flow|Intensive Glycemia Control & Fibrate Placebo|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
10895319|NCT00542178|FG007|Participant Flow|Standard Glycemia Control & Fibrate Placebo|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
10895320|NCT00542178|OG000|Outcome|Intensive Glycemia Control|Strategy of intensive glycemia treatment to HbA1c less than 6%
10895321|NCT00542178|OG001|Outcome|Standard Glycemia Control|Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
10895322|NCT00542178|OG002|Outcome|Intensive Blood Pressure Control|A strategy of BP treatment for SBP less than 120 mmHg
10895323|NCT00542178|OG003|Outcome|Standard Blood Pressure Control|Strategy of BP treatment for SBP less than 140 mmHg
10895324|NCT00542178|OG004|Outcome|Fenofibrate + Simvastatin Therapy|Blinded fenofibrate + simvastatin 20-40 mg/d
10895325|NCT00542178|OG005|Outcome|Placebo + Simvastatin Therapy|Blinded placebo + simvastatin 20-40 mg/d
10895326|NCT00542178|EG000|Reported Event|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
10895327|NCT00542178|EG001|Reported Event|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
10895328|NCT00542178|EG002|Reported Event|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
10895329|NCT00542178|EG003|Reported Event|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
10895330|NCT00542178|EG004|Reported Event|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
10895331|NCT00542178|EG005|Reported Event|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
10895332|NCT00542191|BG000|Baseline|Single Arm Study; Taxol, XRT, Gemzar and Carbo|"Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks~Definitive Surgery: Standard of care definitive surgery as determined by medical provider~Radiotherapy: Standard of care RADIATION THERAPY as indicated"
10895333|NCT00542191|FG000|Participant Flow|Phase II Trial Neoadjuvant Metronomic AC Followed by TC|"Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks~Definitive Surgery: Standard of care definitive surgery as determined by medical provider~Radiotherapy: Standard of care RADIATION THERAPY as indicated"
11171566|NCT02004236|FG002|Participant Flow|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
11171567|NCT02004236|OG000|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
10895334|NCT00542191|OG000|Outcome|Single Arm Study; Taxol, XRT, Gemzar and Carbo|"Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks~Definitive Surgery: Standard of care definitive surgery as determined by medical provider~Radiotherapy: Standard of care RADIATION THERAPY as indicated"
10895335|NCT00542191|EG000|Reported Event|Single Arm Study; Taxol, XRT, Gemzar and Carbo|"Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks~Definitive Surgery: Standard of care definitive surgery as determined by medical provider~Radiotherapy: Standard of care RADIATION THERAPY as indicated"
11171568|NCT02004236|OG001|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
11171569|NCT02004236|OG002|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
11171570|NCT02004236|OG000|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
11171571|NCT02004236|EG000|Reported Event|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
11171572|NCT02004236|EG001|Reported Event|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
11171573|NCT02004236|EG002|Reported Event|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
11171574|NCT02004262|BG000|Baseline|Primary Cohort: Cy/GVAX + CRS-207|
11171575|NCT02004262|BG001|Baseline|Primary Cohort: CRS-207|
11171576|NCT02004262|BG002|Baseline|Primary Cohort: Chemotherapy|
11171577|NCT02004262|BG003|Baseline|2nd-line Cohort: Cy/GVAX + CRS-207|
10895336|NCT00542269|BG000|Baseline|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
11171578|NCT02004262|BG004|Baseline|2nd-line Cohort: CRS-207|
11171579|NCT02004262|BG005|Baseline|2nd-line Cohort: Chemotherapy|
11171580|NCT02004262|BG006|Baseline|Total|Total of all reporting groups
11171581|NCT02004262|FG000|Participant Flow|Primary Cohort: Cy/GVAX + CRS-207|"200 mg per square meter (mg/m^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units [CFU]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.~The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting."
11171582|NCT02004262|FG001|Participant Flow|Primary Cohort: CRS-207|"CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.~The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting."
11171583|NCT02004262|FG002|Participant Flow|Primary Cohort: Chemotherapy|"Investigator's choice of one of the following: gemcitabine (1000 mg/m^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.~The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting."
11171584|NCT02004262|FG003|Participant Flow|2nd-line Cohort: Cy/GVAX + CRS-207|"200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.~The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting."
11171585|NCT02004262|FG004|Participant Flow|2nd-line Cohort: CRS-207|"CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.~The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting."
11171586|NCT02004262|FG005|Participant Flow|2nd-line Cohort: Chemotherapy|"Investigator's choice of one of the following: gemcitabine (1000 mg/m^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.~The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting."
11171587|NCT02004262|OG000|Outcome|Primary Cohort: Cy/GVAX + CRS-207|
11171588|NCT02004262|OG001|Outcome|Primary Cohort: CRS-207|
11171589|NCT02004262|OG002|Outcome|Primary Cohort: Chemotherapy|
11171590|NCT02004262|OG000|Outcome|2nd-line Cohort: Cy/GVAX + CRS-207|
11171591|NCT02004262|OG001|Outcome|2nd-line Cohort: CRS-207|
11171592|NCT02004262|OG002|Outcome|2nd-line Cohort: Chemotherapy|
10895337|NCT00542269|BG001|Baseline|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895338|NCT00542269|BG002|Baseline|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895339|NCT00542269|BG003|Baseline|Total|Total of all reporting groups
10895340|NCT00542269|FG000|Participant Flow|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895341|NCT00542269|FG001|Participant Flow|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895342|NCT00542269|FG002|Participant Flow|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895343|NCT00542269|OG000|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895344|NCT00542269|OG001|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895345|NCT00542269|OG000|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895346|NCT00542269|OG001|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895347|NCT00542269|OG002|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
11171593|NCT02004262|OG000|Outcome|Pooled Cohort: Cy/GVAX + CRS-207|"200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 Cy/GVAX + CRS-207 treatment were combined to form the Pooled Cohort."
11171594|NCT02004262|OG001|Outcome|Pooled Cohort: CRS-207|"CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 CRS-207 treatment were combined to form the Pooled Cohort."
10895348|NCT00542269|EG000|Reported Event|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895349|NCT00542269|EG001|Reported Event|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895350|NCT00542269|EG002|Reported Event|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
10895351|NCT00542308|BG000|Baseline|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
10895352|NCT00542308|FG000|Participant Flow|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
10895353|NCT00542308|OG000|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
10895354|NCT00542308|EG000|Reported Event|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
10895355|NCT00542321|BG000|Baseline|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
10895356|NCT00542321|BG001|Baseline|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
10895357|NCT00542321|BG002|Baseline|Total|Total of all reporting groups
10895358|NCT00542321|FG000|Participant Flow|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
10895359|NCT00542321|FG001|Participant Flow|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
10895360|NCT00542321|OG000|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
10895361|NCT00542321|OG001|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
10895362|NCT00542321|EG000|Reported Event|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
10895363|NCT00542321|EG001|Reported Event|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
10895364|NCT00542386|BG000|Baseline|MCI-196: 3 g|MCI-196: 3 g/ day
10895365|NCT00542386|BG001|Baseline|MCI-196: 6 g|MCI-196: 6 g/ day
10895366|NCT00542386|BG002|Baseline|MCI-196: 9 g|MCI-196: 9 g/ day
10895367|NCT00542386|BG003|Baseline|MCI-196: 12 g|MCI-196: 12 g/ day
10895368|NCT00542386|BG004|Baseline|MCI-196: 15 g|MCI-196: 15 g/ day
10895369|NCT00542386|BG005|Baseline|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
10895370|NCT00542386|BG006|Baseline|Total|Total of all reporting groups
10895371|NCT00542386|FG000|Participant Flow|MCI-196: 3 g|MCI-196: 3 g/ day
10895372|NCT00542386|FG001|Participant Flow|MCI-196: 6 g|MCI-196: 6 g/ day
10895373|NCT00542386|FG002|Participant Flow|MCI-196: 9 g|MCI-196: 9 g/ day
10895374|NCT00542386|FG003|Participant Flow|MCI-196: 12 g|MCI-196: 12 g/ day
10895375|NCT00542386|FG004|Participant Flow|MCI-196: 15 g|MCI-196: 15 g/ day
10895376|NCT00542386|FG005|Participant Flow|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
10895377|NCT00542386|OG000|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
10895378|NCT00542386|OG001|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
10895379|NCT00542386|OG002|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
10895380|NCT00542386|OG003|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
10895381|NCT00542386|OG004|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
10895382|NCT00542386|OG005|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
10895383|NCT00542386|EG000|Reported Event|MCI-196: 3 g|MCI-196: 3 g/ day
10895384|NCT00542386|EG001|Reported Event|MCI-196: 6 g|MCI-196: 6 g/ day
10895385|NCT00542386|EG002|Reported Event|MCI-196: 9 g|MCI-196: 9 g/ day
10895386|NCT00542386|EG003|Reported Event|MCI-196: 12 g|MCI-196: 12 g/ day
10895387|NCT00542386|EG004|Reported Event|MCI-196: 15 g|MCI-196: 15 g/ day
10895388|NCT00542386|EG005|Reported Event|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
10895389|NCT00542425|BG000|Baseline|Placebo|
10895390|NCT00542425|BG001|Baseline|BA058 20 µg|
10895391|NCT00542425|BG002|Baseline|BA058 40 µg|
10895392|NCT00542425|BG003|Baseline|BA058 80 µg|
10895393|NCT00542425|BG004|Baseline|Teriparatide|
10895394|NCT00542425|BG005|Baseline|Total|Total of all reporting groups
10895395|NCT00542425|FG000|Participant Flow|Placebo|
10895396|NCT00542425|FG001|Participant Flow|BA058 20 µg|
10895397|NCT00542425|FG002|Participant Flow|BA058 40 µg|
10895398|NCT00542425|FG003|Participant Flow|BA058 80 µg|
10895399|NCT00542425|FG004|Participant Flow|Teriparatide|
10895400|NCT00542425|OG000|Outcome|Placebo|
10895401|NCT00542425|OG001|Outcome|BA058 20 µg|
10895402|NCT00542425|OG002|Outcome|BA058 40 µg|
11233273|NCT02425449|OG001|Outcome|Arm 2|"0.15 mg/kg of succinycholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895403|NCT00542425|OG003|Outcome|BA058 80 µg|
10895404|NCT00542425|OG004|Outcome|Teriparatide|
10895405|NCT00542425|EG000|Reported Event|Placebo|
10895406|NCT00542425|EG001|Reported Event|BA058 20 µg|
10895407|NCT00542425|EG002|Reported Event|BA058 40 µg|
10895408|NCT00542425|EG003|Reported Event|BA058 80 µg|
10895409|NCT00542425|EG004|Reported Event|Teriparatide|
10895410|NCT00542490|BG000|Baseline|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
10895411|NCT00542490|FG000|Participant Flow|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
10895412|NCT00542490|OG000|Outcome|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
10895413|NCT00542490|EG000|Reported Event|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
10895414|NCT00542620|BG000|Baseline|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
10895415|NCT00542620|BG001|Baseline|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
10895416|NCT00542620|BG002|Baseline|Total|Total of all reporting groups
10895417|NCT00542620|FG000|Participant Flow|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
10895418|NCT00542620|FG001|Participant Flow|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
10895419|NCT00542620|OG000|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
10895420|NCT00542620|OG001|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
10895421|NCT00542620|EG000|Reported Event|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
10895422|NCT00542620|EG001|Reported Event|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
10895423|NCT00542750|BG000|Baseline|N-acetylcysteine|All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
10895424|NCT00542750|FG000|Participant Flow|N-acetylcysteine|All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
10895425|NCT00542750|OG000|Outcome|N-acetylcysteine|All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
10895426|NCT00542750|EG000|Reported Event|N-acetylcysteine|All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
10895427|NCT00542789|BG000|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
10895428|NCT00542789|BG001|Baseline|Comparater: Placebo|Placebo once daily oral
10895429|NCT00542789|BG002|Baseline|Total|Total of all reporting groups
10895430|NCT00542789|FG000|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
10895431|NCT00542789|FG001|Participant Flow|Comparater: Placebo|Placebo once daily oral
10895432|NCT00542789|OG000|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
10895433|NCT00542789|OG001|Outcome|Comparater: Placebo|Placebo once daily oral
10895434|NCT00542789|EG000|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
10895435|NCT00542789|EG001|Reported Event|Comparater: Placebo|Placebo once daily oral
10895436|NCT00542815|BG000|Baseline|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
10895437|NCT00542815|BG001|Baseline|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
10895438|NCT00542815|BG002|Baseline|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
10895439|NCT00542815|BG003|Baseline|Total|Total of all reporting groups
10895440|NCT00542815|FG000|Participant Flow|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
10895441|NCT00542815|FG001|Participant Flow|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
10895442|NCT00542815|FG002|Participant Flow|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
10895443|NCT00542815|OG000|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
11233274|NCT02425449|OG002|Outcome|Arm 3|"0.2 mg/kg of succinylcholne arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895444|NCT00542815|OG001|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
10895445|NCT00542815|OG002|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
10895446|NCT00542815|EG000|Reported Event|MCI-196 From E07/E08 Studies|3, 6, 9, 12, or 15g / day as titrated
10895447|NCT00542815|EG001|Reported Event|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
10895448|NCT00542815|EG002|Reported Event|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
10895449|NCT00542828|BG000|Baseline|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
10895450|NCT00542828|FG000|Participant Flow|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
10895451|NCT00542828|OG000|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
10895452|NCT00542828|EG000|Reported Event|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
10895453|NCT00542880|BG000|Baseline|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
10895454|NCT00542880|BG001|Baseline|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
10895455|NCT00542880|BG002|Baseline|Total|Total of all reporting groups
10895456|NCT00542880|FG000|Participant Flow|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
10895457|NCT00542880|FG001|Participant Flow|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
10895458|NCT00542880|OG000|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
10895459|NCT00542880|OG001|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
10895460|NCT00542880|OG001|Outcome|Seretide Diskus First|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
10895461|NCT00542880|EG000|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
10895462|NCT00542880|EG001|Reported Event|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
10895463|NCT00542919|BG000|Baseline|T-Cell|T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895464|NCT00542919|BG001|Baseline|Indolent B-Cell|Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895465|NCT00542919|BG002|Baseline|Aggressive B-Cell|Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895466|NCT00542919|BG003|Baseline|Total|Total of all reporting groups
10895467|NCT00542919|FG000|Participant Flow|T-Cell (TCL)|T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 milligram (mg) loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895468|NCT00542919|FG001|Participant Flow|Indolent B-Cell (IBCL)|Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895469|NCT00542919|FG002|Participant Flow|Aggressive B-Cell (ABCL)|Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895470|NCT00542919|OG000|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants who had PTCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895471|NCT00542919|OG001|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants who had CTCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895472|NCT00542919|OG002|Outcome|Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)|Participants who had small lymphocytic IBCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895473|NCT00542919|OG003|Outcome|Follicular Grade 1 & 2 (IBCL)|Participants who had follicular grade 1 & 2 IBCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895474|NCT00542919|OG004|Outcome|Marginal Zone Lymphoma (IBCL)|Participants who had marginal zone lymphoma IBCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895475|NCT00542919|OG005|Outcome|Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)|Participants who had follicular grade 3 a ABCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895476|NCT00542919|OG006|Outcome|History of IBCL (ABCL)|Participants who had a history of IBCL (ABCL) tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895477|NCT00542919|OG000|Outcome|PTCL|Participants who had PTCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895478|NCT00542919|OG001|Outcome|CTCL|Participants who had CTCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895479|NCT00542919|OG002|Outcome|Small Lymphocytic (IBCL)|Participants who had small lymphocytic IBCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895480|NCT00542919|OG005|Outcome|Follicular Grade 3a & 4b (ABCL)|Participants who had follicular grade 3 & 4 ABCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895481|NCT00542919|OG006|Outcome|History of IBCL (ABCL)|Participants who had history of IBCL (ABCL) tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895482|NCT00542919|OG004|Outcome|Marginal Zone Lymphoma Disease (IBCL)|Participants who had marginal zone lymphoma (IBCL) tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895483|NCT00542919|OG005|Outcome|Follicular Grade 3 & 4 (ABCL)|Participants who had follicular grade 3 & 4 ABCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895484|NCT00542919|OG006|Outcome|History of IBCL (ABCL)|Participants who had history of IBCL ABCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895485|NCT00542919|OG000|Outcome|T-Cell|Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895486|NCT00542919|OG001|Outcome|Indolent B-Cell|Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895487|NCT00542919|OG002|Outcome|Aggressive B-Cell|Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895488|NCT00542919|EG000|Reported Event|T-Cell|Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895489|NCT00542919|EG001|Reported Event|Indolent B-Cell|Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895490|NCT00542919|EG002|Reported Event|Aggressive B-Cell|Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
10895491|NCT00542971|BG000|Baseline|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
10895492|NCT00542971|FG000|Participant Flow|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
10895493|NCT00542971|OG000|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
10895494|NCT00542971|EG000|Reported Event|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
10895495|NCT00542997|BG000|Baseline|IgPro20 (All Treated)|All subjects enrolled and treated with subcutaneous infusion of IgPro20
10895496|NCT00542997|FG000|Participant Flow|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
10895497|NCT00542997|OG000|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
10895498|NCT00542997|OG001|Outcome|Pre-study IgG Treatment|Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
10895499|NCT00542997|OG000|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
10895500|NCT00542997|OG000|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
10895501|NCT00542997|EG000|Reported Event|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
10895502|NCT00543062|BG000|Baseline|Safety Population|All subjects were to receive all 4 treatments in this 4 treatment crossover
10895503|NCT00543062|FG000|Participant Flow|Treatment Sequence ABCD|All subjects were to receive all 4 treatments in this 4 treatment crossover
10895504|NCT00543062|FG001|Participant Flow|Treatment Sequence BDAC|All subjects were to receive all 4 treatments in this 4 treatment crossover
10895505|NCT00543062|FG002|Participant Flow|Treatment Sequence CABD|All subjects were to receive all 4 treatments in this 4 treatment crossover
10895506|NCT00543062|FG003|Participant Flow|Treatment Sequence DCBA|All subjects were to receive all 4 treatments in this 4 treatment crossover
10895507|NCT00543062|OG000|Outcome|Placebo+Inhaled Prochlorperazine 5 mg Crossover Subjects|"All subjects who completed both treatments B and C: Treatment: B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo~The analyses are based on a within (paired) comparison of the time matched drug - placebo QTc values."
10895508|NCT00543062|OG001|Outcome|Placebo+Inhaled Prochlorperazine 10 mg Crossover Subjects|"All subjects who completed both treatments A and C: Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, C = Inhaled placebo + oral placebo.~The analyses are based on a within (paired) comparison of the time matched drug - placebo QTc values."
10895509|NCT00543062|OG000|Outcome|Inhaled Prochlorperazine|Serum concentrations following Staccato prochlorperazine 5 and 10 mg, single dose
10895510|NCT00543062|OG000|Outcome|Placebo|"Inhaled placebo Oral placebo~Inhaled placebo: Inhaled Staccato placebo (0 mg)~Oral placebo: Oral placebo (identical to 400 mg moxifloxacin)"
10895511|NCT00543062|OG001|Outcome|Inhaled Prochlorperazine 5 mg|"Staccato prochlorperazine 5 mg, single dose Oral placebo~Oral placebo: Oral placebo (identical to 400 mg moxifloxacin)~Inhaled prochlorperazine 5 mg: Staccato prochlorperazine 5 mg, single dose"
10895512|NCT00543062|OG002|Outcome|Inhaled Prochlorperazine 10 mg|"Staccato prochlorperazine 10 mg, single dose Oral placebo~Oral placebo: Oral placebo (identical to 400 mg moxifloxacin)~Inhaled prochlorperazine 10 mg: Inhaled prochlorperazine 10 mg, single dose"
10895513|NCT00543062|OG000|Outcome|Placebo|Inhaled placebo + Oral placebo
10895514|NCT00543062|OG001|Outcome|Inhaled Prochlorperazine 5 mg|Staccato prochlorperazine 5 mg, single dose Oral placebo
10895515|NCT00543062|OG002|Outcome|Inhaled Prochlorperazine 10 mg|Inhaled prochlorperazine 10 mg: Inhaled prochlorperazine 10 mg, single dose
10895516|NCT00543062|OG001|Outcome|Inhaled Prochlorperazine 5 mg|Staccato prochlorperazine 5 mg, single dose + Oral placebo
10895517|NCT00543062|OG002|Outcome|Inhaled Prochlorperazine 10 mg|Inhaled prochlorperazine 10 mg: Inhaled prochlorperazine 10 mg, single dose + Oral placebo
10895518|NCT00543062|OG000|Outcome|Placebo+Oral Moxifloxacin 400 mg Crossover Subjects|"All subjects who completed both treatments C and D: Treatment: C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg~The analyses are based on a within (paired) comparison of the time matched drug - placebo QTc values."
11171595|NCT02004262|OG002|Outcome|Pooled Cohort: Chemotherapy|"Investigator's choice of one of the following: gemcitabine (1000 mg/m^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 chemotherapy treatment were combined to form the Pooled Cohort."
11171596|NCT02004262|EG000|Reported Event|Pooled Cohort: Cy/GVAX + CRS-207|"200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 Cy/GVAX + CRS-207 treatment were combined to form the Pooled Cohort."
11171597|NCT02004262|EG001|Reported Event|Pooled Cohort: CRS-207|"CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 CRS-207 treatment were combined to form the Pooled Cohort."
11171598|NCT02004262|EG002|Reported Event|Pooled Cohort: Chemotherapy|"Investigator's choice of one of the following: gemcitabine (1000 mg/m^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 chemotherapy treatment were combined to form the Pooled Cohort."
10895519|NCT00543062|EG000|Reported Event|Placebo|"Inhaled placebo Oral placebo~Inhaled placebo: Inhaled Staccato placebo (0 mg)~Oral placebo: Oral placebo (identical to 400 mg moxifloxacin)"
10895520|NCT00543062|EG001|Reported Event|Inhaled Prochlorperazine 5 mg|"Staccato prochlorperazine 5 mg, single dose Oral placebo~Oral placebo: Oral placebo (identical to 400 mg moxifloxacin)~Inhaled prochlorperazine 5 mg: Staccato prochlorperazine 5 mg, single dose"
10895521|NCT00543062|EG002|Reported Event|Inhaled Prochlorperazine 10 mg|"Staccato prochlorperazine 10 mg, single dose Oral placebo~Oral placebo: Oral placebo (identical to 400 mg moxifloxacin)~Inhaled prochlorperazine 10 mg: Inhaled prochlorperazine 10 mg, single dose"
10895522|NCT00543062|EG003|Reported Event|Oral Moxifloxacin 400 mg|"Oral moxifloxacin 400 mg Inhaled placebo~Inhaled placebo: Inhaled Staccato placebo (0 mg)~Oral moxifloxacin: Oral moxifloxacin 400 mg, si/ngle dose"
10895523|NCT00543101|BG000|Baseline|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
11171599|NCT02004288|BG000|Baseline|Lactobacillus Reuteri Protectis DSM17938|"One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit)~Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months."
11171600|NCT02004288|BG001|Baseline|Placebo|"One chewable tablet twice per day with placebo per day~Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months."
10895524|NCT00543101|BG001|Baseline|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
11171601|NCT02004288|BG002|Baseline|Total|Total of all reporting groups
10895525|NCT00543101|BG002|Baseline|Total|Total of all reporting groups
10895526|NCT00543101|FG000|Participant Flow|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
10895527|NCT00543101|FG001|Participant Flow|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
10895528|NCT00543101|OG000|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
10895529|NCT00543101|OG001|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
10895530|NCT00543101|OG001|Outcome|Crossover Week 48|At week 24 the dual PI arm subjects remaining undetectable, crossed over to the DRV/r arm and were followed for an additional 24 weeks.
10895531|NCT00543101|EG000|Reported Event|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
10895532|NCT00543101|EG001|Reported Event|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
10895533|NCT00543127|BG000|Baseline|Fulvestrant + Anastrozole|Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.
10895534|NCT00543127|BG001|Baseline|Anastrozole|Anastrozole: 1 mg oral Anastrozole per day during 5 years.
10895535|NCT00543127|BG002|Baseline|Total|Total of all reporting groups
10895536|NCT00543127|FG000|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.
10895537|NCT00543127|FG001|Participant Flow|Anastrozole|Anastrozole: 1 mg oral Anastrozole per day during 5 years.
11171602|NCT02004288|FG000|Participant Flow|Lactobacillus Reuteri Protectis DSM17938|"One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit)~Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months."
11171603|NCT02004288|FG001|Participant Flow|Placebo|"One chewable tablet twice per day with placebo per day~Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months."
11171604|NCT02004288|OG000|Outcome|Lactobacillus Reuteri Protectis DSM17938|"One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit)~Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months."
11171605|NCT02004288|OG001|Outcome|Placebo|"One chewable tablet twice per day with placebo per day~Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months."
10895538|NCT00543127|OG000|Outcome|Fulvestrant + Anastrozole|Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.
10895539|NCT00543127|OG001|Outcome|Anastrozole|Anastrozole: 1 mg oral Anastrozole per day during 5 years.
10895540|NCT00543127|EG000|Reported Event|Fulvestrant + Anastrozole|Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.
10895541|NCT00543127|EG001|Reported Event|Anastrozole|Anastrozole: 1 mg oral Anastrozole per day during 5 years.
11171606|NCT02004288|EG000|Reported Event|Lactobacillus Reuteri Protectis DSM17938|"One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit)~Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months."
10895542|NCT00543140|BG000|Baseline|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
10895543|NCT00543140|FG000|Participant Flow|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
10895544|NCT00543140|OG000|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
10895545|NCT00543140|EG000|Reported Event|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
10895546|NCT00543296|BG000|Baseline|0.59 mg Fluocinolone Acetonide Implant|
10895547|NCT00543296|FG000|Participant Flow|0.59 mg Fluocinolone Acetonide Implant|
10895548|NCT00543296|OG000|Outcome|0.59 mg Fluocinolone Acetonide Implant|
11171607|NCT02004288|EG001|Reported Event|Placebo|"One chewable tablet twice per day with placebo per day~Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months."
11171608|NCT02004353|BG000|Baseline|Cochlear® Hearing Implants|Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
11171609|NCT02004353|FG000|Participant Flow|Cochlear® Hearing Implants|Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
11171610|NCT02004353|OG000|Outcome|Cochlear® Hearing Implants|Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
10895549|NCT00543296|EG000|Reported Event|0.59 mg Fluocinolone Acetonide Implant|
10895550|NCT00543309|BG000|Baseline|I- Nesiritide|"Patients assigned to the nesiritide group will receive an intravenous loading dose of 2 mcg/kg followed by an infusion of 0.015 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~nesiritide: Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted"
10895551|NCT00543309|BG001|Baseline|II- Milrinone|"Patients assigned to the milrinone group will receive a bolus of 50 mcg/kg followed by an infusion of 0.5 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~milrinone: Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted"
10895552|NCT00543309|BG002|Baseline|III- Placebo|"Patients assigned to the placebo group will receive a 0.33 mL/kg bolus of 5% dextrose in water (D5W), followed by an infusion of D5W, administered for at least 12 hours after CICU admission and up to five days, unless prespecified lack of efficacy criteria are met.~placebo: Placebo bolus on CPB, then placebo infusion"
10895553|NCT00543309|BG003|Baseline|Total|Total of all reporting groups
10895554|NCT00543309|FG000|Participant Flow|I- Nesiritide|"Patients assigned to the nesiritide group will receive an intravenous loading dose of 2 mcg/kg followed by an infusion of 0.015 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~nesiritide: Nesiritide bolus 2 mcg/kg on cardiopulmonary bypass (CPB), then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted"
10895555|NCT00543309|FG001|Participant Flow|II- Milrinone|"Patients assigned to the milrinone group will receive a bolus of 50 mcg/kg followed by an infusion of 0.5 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~milrinone: Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted"
10895556|NCT00543309|FG002|Participant Flow|III- Placebo|"Patients assigned to the placebo group will receive a 0.33 mL/kg bolus of 5% dextrose in water (D5W), followed by an infusion of D5W, administered for at least 12 hours after CICU admission and up to five days, unless prespecified lack of efficacy criteria are met.~placebo: Placebo bolus on CPB, then placebo infusion"
10895557|NCT00543309|OG000|Outcome|I- Nesiritide|"Patients assigned to the nesiritide group will receive an intravenous loading dose of 2 mcg/kg followed by an infusion of 0.015 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~nesiritide: Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted"
10895558|NCT00543309|OG001|Outcome|II- Milrinone|"Patients assigned to the milrinone group will receive a bolus of 50 mcg/kg followed by an infusion of 0.5 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~milrinone: Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted"
10895559|NCT00543309|OG002|Outcome|III- Placebo|"Patients assigned to the placebo group will receive a 0.33 mL/kg bolus of 5% dextrose in water (D5W), followed by an infusion of D5W, administered for at least 12 hours after CICU admission and up to five days, unless prespecified lack of efficacy criteria are met.~placebo: Placebo bolus on CPB, then placebo infusion"
10895560|NCT00543309|OG000|Outcome|I- Nesiritide|"Patients assigned to the nesiritide group will receive an intravenous loading dose of 2 mcg/kg followed by an infusion of 0.015 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~nesiritide: Nesiritide bolus 2 mcg/kg on cardiopulmonary bypass (CPB), then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted"
11171611|NCT02004353|EG000|Reported Event|Cochlear® Hearing Implants|Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
11171612|NCT02004366|BG000|Baseline|Linagliptin In-hospital|"Linagliptin once daily+ correction doses of aspart or lispro if needed~Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed"
11171613|NCT02004366|BG001|Baseline|Basal Bolus In-hospital|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
11171614|NCT02004366|BG002|Baseline|Linagliptin on Discharge|"Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.~Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months."
11171615|NCT02004366|BG003|Baseline|Linagliptin+50%Glargine Dose on d/c|"Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.~Linagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months."
11171616|NCT02004366|BG004|Baseline|Linagliptin+80%Glargine Dose on d/c|"Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.~Linagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months."
10895561|NCT00543309|EG000|Reported Event|I- Nesiritide|"Patients assigned to the nesiritide group will receive an intravenous loading dose of 2 mcg/kg followed by an infusion of 0.015 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~nesiritide: Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted"
10895562|NCT00543309|EG001|Reported Event|II- Milrinone|"Patients assigned to the milrinone group will receive a bolus of 50 mcg/kg followed by an infusion of 0.5 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.~milrinone: Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted"
10895563|NCT00543309|EG002|Reported Event|III- Placebo|"Patients assigned to the placebo group will receive a 0.33 mL/kg bolus of 5% dextrose in water (D5W), followed by an infusion of D5W, administered for at least 12 hours after CICU admission and up to five days, unless prespecified lack of efficacy criteria are met.~placebo: Placebo bolus on CPB, then placebo infusion"
10895564|NCT00543387|BG000|Baseline|MK-5108 200 mg BID (Panel 1)|Participants received 200 mg of MK-5108 orally twice daily (BID) the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
11171617|NCT02004366|BG005|Baseline|Total|Total of all reporting groups
11171618|NCT02004366|FG000|Participant Flow|Linagliptin In-hospital|"Linagliptin once daily + correction doses of aspart or lispro if needed.~Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed"
10895565|NCT00543387|BG001|Baseline|MK-5108 400 mg BID (Panel 1)|Participants received 400 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895566|NCT00543387|BG002|Baseline|MK-5108 800 mg BID (Panel 1)|Participants received 800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895567|NCT00543387|BG003|Baseline|MK-5108 1200 mg BID (Panel 1)|Participants received 1200 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895568|NCT00543387|BG004|Baseline|MK-5108 1500 mg BID (Panel 1)|Participants received 1500 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895569|NCT00543387|BG005|Baseline|MK-5108 1800 mg BID (Panel 1)|Participants received 1800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895570|NCT00543387|BG006|Baseline|MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered intravenously (IV) the first 2 days of a 21-day cycle.
10895571|NCT00543387|BG007|Baseline|MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895572|NCT00543387|BG008|Baseline|MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895573|NCT00543387|BG009|Baseline|Total|Total of all reporting groups
10895574|NCT00543387|FG000|Participant Flow|MK-5108 200 mg BID (Panel 1)|Participants received 200 mg of MK-5108 orally twice daily (BID) the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895575|NCT00543387|FG001|Participant Flow|MK-5108 400 mg BID (Panel 1)|Participants received 400 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895576|NCT00543387|FG002|Participant Flow|MK-5108 800 mg BID (Panel 1)|Participants received 800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895577|NCT00543387|FG003|Participant Flow|MK-5108 1200 mg BID (Panel 1)|Participants received 1200 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895578|NCT00543387|FG004|Participant Flow|MK-5108 1500 mg BID (Panel 1)|Participants received 1500 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895579|NCT00543387|FG005|Participant Flow|MK-5108 1800 mg BID (Panel 1)|Participants received 1800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895580|NCT00543387|FG006|Participant Flow|MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered intravenously (IV) the first 2 days of a 21-day cycle.
10895581|NCT00543387|FG007|Participant Flow|MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895582|NCT00543387|FG008|Participant Flow|MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895583|NCT00543387|FG009|Participant Flow|MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover)|After receiving treatment in Panel 1, one participant crossed over to Panel 2 per protocol following disease progression to receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
11233275|NCT02425449|OG003|Outcome|Arm 4|"0.25 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895584|NCT00543387|FG010|Participant Flow|MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover)|After receiving treatment in Panel 1, participants crossed over to Panel 2 per protocol following disease progression to receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895585|NCT00543387|OG000|Outcome|MK-5108 200 mg BID (Panel 1)|Participants received 200 mg of MK-5108 orally twice daily (BID) the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895586|NCT00543387|OG001|Outcome|MK-5108 400 mg BID (Panel 1)|Participants received 400 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895587|NCT00543387|OG002|Outcome|MK-5108 800 mg BID (Panel 1)|Participants received 800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895588|NCT00543387|OG003|Outcome|MK-5108 1200 mg BID (Panel 1)|Participants received 1200 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895589|NCT00543387|OG004|Outcome|MK-5108 1500 mg BID (Panel 1)|Participants received 1500 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895590|NCT00543387|OG005|Outcome|MK-5108 1800 mg BID (Panel 1)|Participants received 1800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895591|NCT00543387|OG006|Outcome|MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered intravenously (IV) the first 2 days of a 21-day cycle.
10895592|NCT00543387|OG007|Outcome|MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895593|NCT00543387|OG008|Outcome|MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2)|Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895594|NCT00543387|OG009|Outcome|MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover)|After receiving treatment in Panel 1, one participant crossed over to Panel 2 per protocol following disease progression to receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895595|NCT00543387|OG010|Outcome|MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover)|After receiving treatment in Panel 1, participants crossed over to Panel 2 per protocol following disease progression to receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895596|NCT00543387|EG000|Reported Event|MK-5108 200 mg BID (Panel 1)|Participants received 200 mg of MK-5108 orally twice daily (BID) the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895597|NCT00543387|EG001|Reported Event|MK-5108 400 mg BID (Panel 1)|Participants received 400 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895598|NCT00543387|EG002|Reported Event|MK-5108 800 mg BID (Panel 1)|Participants received 800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895599|NCT00543387|EG003|Reported Event|MK-5108 1200 mg BID (Panel 1)|Participants received 1200 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895600|NCT00543387|EG004|Reported Event|MK-5108 1500 mg BID (Panel 1)|Participants received 1500 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895601|NCT00543387|EG005|Reported Event|MK-5108 1800 mg BID (Panel 1)|Participants received 1800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
10895602|NCT00543387|EG006|Reported Event|MK-5108 100 mg BID + 60 mg/m2 Docetaxel (Panel 2)|Participants received 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered intravenously (IV) the first 2 days of a 21-day cycle.
10895603|NCT00543387|EG007|Reported Event|MK-5108 150 mg BID + 60 mg/m2 Docetaxel (Panel 2)|Participants received 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895604|NCT00543387|EG008|Reported Event|MK-5108 225 mg BID + 60 mg/m2 Docetaxel (Panel 2)|Participants received 225 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895605|NCT00543387|EG009|Reported Event|MK-5108 100 mg BID + 60 mg/m2 Docetaxel (Crossover)|After receiving treatment in Panel 1, one participant crossed over to Panel 2 per protocol following disease progression to receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895606|NCT00543387|EG010|Reported Event|MK-5108 150 mg BID + 60 mg/m2 Docetaxel (Crossover)|After receiving treatment in Panel 1, participants crossed over to Panel 2 per protocol following disease progression to receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
10895607|NCT00543400|BG000|Baseline|70 U/kg of Unfractionated Heparin Given IV|Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895608|NCT00543400|BG001|Baseline|50 IU/KG of M118|Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895609|NCT00543400|BG002|Baseline|75 IU/KG of M118|Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895610|NCT00543400|BG003|Baseline|100 IU/KG of M118|Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895611|NCT00543400|BG004|Baseline|Total|Total of all reporting groups
10895612|NCT00543400|FG000|Participant Flow|70 U/kg of Unfractionated Heparin Given IV|Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895613|NCT00543400|FG001|Participant Flow|50 IU/kg of M118|Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895614|NCT00543400|FG002|Participant Flow|75 IU/KG of M118|Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895615|NCT00543400|FG003|Participant Flow|100 IU/kg of M118|Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895616|NCT00543400|OG000|Outcome|70 U/kg of Unfractionated Heparin Given IV|Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895617|NCT00543400|OG001|Outcome|50 IU/kg of M118|Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895618|NCT00543400|OG002|Outcome|75 IU/KG of M118|Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895619|NCT00543400|OG003|Outcome|100 IU/kg of M118|Venous injection of 100 IU/kg of M118 prior to Percutaneous Coronary Intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895620|NCT00543400|EG000|Reported Event|70 U/kg of Unfractionated Heparin Given IV|Venous injection of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895621|NCT00543400|EG001|Reported Event|50 IU/kg of M118|Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895622|NCT00543400|EG002|Reported Event|75 IU/KG of M118|Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895623|NCT00543400|EG003|Reported Event|100 IU/kg of M118|Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
10895624|NCT00543439|BG000|Baseline|Moroctocog Alfa (AF-CC),OD Cohort:OD Therapy Then RP Therapy|Participants who consented for pharmacokinetic assessment received single 50 international units per kilogram [IU/kg] infusion of AF-CC on Day 1 prior start of study treatment.Period 1:participants were treated with on-demand (OD) therapy intravenous (IV) infusion of AF-CC for 6 months(Day 1 up to Month 6)prescribed by investigator based on current recommendations for OD therapy with licensed product Xyntha (Minor bleeding:repetition of IV infusion of AF-CC,20-40 IU/kg,every 12-24 hours (hr) until resolved for at least 1 day,depending upon severity of bleeding episode;Moderate bleeding:repetition of IV infusion of AF-CC,30-60 IU/kg,every 12-24 hr for 3-4 days/until adequate local hemostasis achieved;Major bleeding:repetition of IV infusion of AF-CC,60-100 IU/kg,every 8-24 hr until bleeding resolved).Then in Period 2 participants received IV infusion of AF-CC at 25 IU/kg once in 2 days up to 12 months (Month 7 to Month 18) as RP therapy and if required were treated with OD IV infusion.
10895625|NCT00543439|BG001|Baseline|Moroctocog Alfa(AF-CC),RP Cohort:RP 25 IU/kg Then RP 45IU/kg|Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg, twice per week up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.
10895626|NCT00543439|BG002|Baseline|Moroctocog Alfa(AF-CC), RP Cohort:RP 45 IU/kg Then RP25IU/kg|Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg twice per week up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.
10895627|NCT00543439|BG003|Baseline|Total|Total of all reporting groups
10895628|NCT00543439|FG000|Participant Flow|Moroctocog Alfa (AF-CC),OD Cohort:OD Therapy Then RP Therapy|Participants who consented for pharmacokinetic assessment received single 50 international units per kilogram [IU/kg] infusion of AF-CC on Day 1 prior start of study treatment.Period 1:participants were treated with on-demand (OD) therapy intravenous (IV) infusion of AF-CC for 6 months(Day 1 up to Month 6)prescribed by investigator based on current recommendations for OD therapy with licensed product Xyntha (Minor bleeding:repetition of IV infusion of AF-CC,20-40 IU/kg,every 12-24 hours (hr) until resolved for at least 1 day,depending upon severity of bleeding episode;Moderate bleeding:repetition of IV infusion of AF-CC,30-60 IU/kg,every 12-24 hr for 3-4 days/until adequate local hemostasis achieved;Major bleeding:repetition of IV infusion of AF-CC,60-100 IU/kg,every 8-24 hr until bleeding resolved).Then in Period 2 participants received IV infusion of AF-CC at 25 IU/kg once in 2 days up to 12 months (Month 7 to Month 18) as RP therapy and if required were treated with OD IV infusion.
10895629|NCT00543439|FG001|Participant Flow|Moroctocog Alfa(AF-CC),RP Cohort:RP 25 IU/kg Then RP 45IU/kg|Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg, twice per week up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.
10895630|NCT00543439|FG002|Participant Flow|Moroctocog Alfa(AF-CC), RP Cohort:RP 45 IU/kg Then RP25IU/kg|Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg twice per week up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.
10895631|NCT00543439|OG000|Outcome|Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy|In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).
11233276|NCT02425449|OG004|Outcome|Arm 5|"0.3 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895632|NCT00543439|OG001|Outcome|Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg|In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.
10895633|NCT00543439|OG000|Outcome|Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 45 IU/kg|Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg, twice per week up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.
10895634|NCT00543439|OG001|Outcome|Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg|Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.
10895635|NCT00543439|OG000|Outcome|Moroctocog Alfa (AF-CC): All Participants|All participants who received moroctocog alfa-(AF-CC) 50 IU/kg for PK assessment on Day 1 prior start of study treatment and as on demand or routine prophylaxis treatment (25 and 45 IU/kg).
10895636|NCT00543439|OG000|Outcome|Moroctocog Alfa (AF-CC): On Demand Therapy|Participants of either on demand cohort or routine prophylaxis cohort were treated for bleeds, as needed on demand, with IV infusion of moroctocog alfa (AF-CC) up to 24 months as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).
11233277|NCT02425449|EG000|Reported Event|Arm 1|"0.1 mg/kg of succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895637|NCT00543439|OG001|Outcome|Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg|Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
10895638|NCT00543439|OG000|Outcome|Moroctocog Alfa(AF-CC), On Demand Cohort: RP Therapy 25IU/kg|In Period 2, participants of on demand cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.
10895639|NCT00543439|OG001|Outcome|Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 45 IU/kg|Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg, twice per week up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.
10895640|NCT00543439|OG002|Outcome|Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg|Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.
10895641|NCT00543439|OG003|Outcome|Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg|Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
10895642|NCT00543439|OG000|Outcome|Moroctocog Alfa (AF-CC): 50 IU/kg|Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort.
10895643|NCT00543439|OG000|Outcome|Moroctocog Alfa (AF-CC) OD Cohort: OD Therapy|In Period 1, participants of OD cohort, as OD therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of AF-CC, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of AF-CC, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of AF-CC, 60-100 IU/kg, every 8-24 hours until bleeding was resolved).
10895644|NCT00543439|OG002|Outcome|Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg|Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
10895645|NCT00543439|EG000|Reported Event|Moroctocog Alfa (AF-CC): All Participants|All participants who received moroctocog alfa-(AF-CC) 50 IU/kg for PK assessment on Day 1 prior start of study treatment and as on demand or routine prophylaxis treatment (25 and 45 IU/kg).
10895646|NCT00543543|BG000|Baseline|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
10895647|NCT00543543|BG001|Baseline|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
10895648|NCT00543543|BG002|Baseline|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
10895649|NCT00543543|BG003|Baseline|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
10895650|NCT00543543|BG004|Baseline|Total|Total of all reporting groups
10895651|NCT00543543|FG000|Participant Flow|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
10895652|NCT00543543|FG001|Participant Flow|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
10895653|NCT00543543|FG002|Participant Flow|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
10895654|NCT00543543|FG003|Participant Flow|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
10895655|NCT00543543|OG000|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
10895656|NCT00543543|OG001|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
10895657|NCT00543543|OG000|Outcome|Extension Study: Mid-dose V503 (Cohort 1)|V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
10895658|NCT00543543|OG000|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
11171619|NCT02004366|FG001|Participant Flow|Basal Bolus In-hospital|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
11233278|NCT02425449|EG001|Reported Event|Arm 2|"0.15 mg/kg of succinycholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895659|NCT00543543|OG001|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
10895660|NCT00543543|OG002|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
10895661|NCT00543543|OG003|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
10895662|NCT00543543|EG000|Reported Event|Base Study: Low-Dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
10895663|NCT00543543|EG001|Reported Event|Base Study: Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) will receive a fourth V503 mid-dose vaccination in the extension study.
10895664|NCT00543543|EG002|Reported Event|Base Study: High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
10895665|NCT00543543|EG003|Reported Event|Base Study: Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) will be offered the V503 mid-dose 3-dose regimen in the extension study.
10895666|NCT00543543|EG004|Reported Event|Extension Study: Mid-dose V503 (Cohort 1)|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL fourth dose administration in Base Study participants who were randomized to receive a 3-dose regimen of V503 (9-Valent HPV) mid-dose 0.5 mL (Cohort 1).
10895667|NCT00543543|EG005|Reported Event|Extension Study: Mid-dose V503 (Cohort 2)|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL 3-dose regimen administration on Base Study participants who were randomized to receive a 3-dose regimen of Gardasil (4-Valent HPV Vaccine) (Cohort 2).
10895668|NCT00543569|BG000|Baseline|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
10895669|NCT00543569|BG001|Baseline|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
10895670|NCT00543569|BG002|Baseline|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
10895671|NCT00543569|BG003|Baseline|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
11171620|NCT02004366|FG002|Participant Flow|Linagliptin on Discharge|"Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.~Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months."
10895672|NCT00543569|BG004|Baseline|Total|Total of all reporting groups
10895673|NCT00543569|FG000|Participant Flow|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
10895674|NCT00543569|FG001|Participant Flow|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
10895675|NCT00543569|FG002|Participant Flow|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
11233279|NCT02425449|EG002|Reported Event|Arm 3|"0.2 mg/kg of succinylcholne arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
11233280|NCT02425449|EG003|Reported Event|Arm 4|"0.25 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895676|NCT00543569|FG003|Participant Flow|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
10895677|NCT00543569|OG000|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
10895678|NCT00543569|OG001|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
10895679|NCT00543569|OG002|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
10895680|NCT00543569|OG003|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
10895681|NCT00543569|EG000|Reported Event|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
10895682|NCT00543569|EG001|Reported Event|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
10895683|NCT00543569|EG002|Reported Event|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
10895684|NCT00543569|EG003|Reported Event|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
10895685|NCT00543725|BG000|Baseline|TMC278|25 mg tablet once daily
10895686|NCT00543725|BG001|Baseline|Efavirenz|600 mg once daily
10895687|NCT00543725|BG002|Baseline|Total|Total of all reporting groups
10895688|NCT00543725|FG000|Participant Flow|TMC278|25 mg tablet once daily
10895689|NCT00543725|FG001|Participant Flow|Efavirenz|600 mg once daily
10895690|NCT00543725|OG000|Outcome|TMC278|25 mg tablet once daily
10895691|NCT00543725|OG001|Outcome|Efavirenz|600 mg once daily
10895692|NCT00543725|EG000|Reported Event|TMC278|25 mg tablet once daily
10895693|NCT00543725|EG001|Reported Event|Efavirenz|600 mg once daily
10895694|NCT00543764|BG000|Baseline|Pre Pathway|Patients prior to pathway implementation
10895695|NCT00543764|BG001|Baseline|Post Pathway|Patients after pathway implementation
11090470|NCT01529346|FG000|Participant Flow|PF-05089771 150 mg|Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter [mm] on a 100 mm Visual Analog Scale [VAS] pain severity rating scale).
11233281|NCT02425449|EG004|Reported Event|Arm 5|"0.3 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
10895696|NCT00543764|BG002|Baseline|Total|Total of all reporting groups
10895697|NCT00543764|FG000|Participant Flow|Pre Pathway|Patients prior to pathway implementation
10895698|NCT00543764|FG001|Participant Flow|Post Pathway|Patients after pathway implementation
10895699|NCT00543764|OG000|Outcome|Pre Pathway|Patients prior to pathway implementation
10895700|NCT00543764|OG001|Outcome|Post Pathway|Patients after pathway implementation
10895701|NCT00543764|EG000|Reported Event|Pre Pathway|Patients prior to pathway implementation
10895702|NCT00543764|EG001|Reported Event|Post Pathway|Patients after pathway implementation
11090471|NCT01529346|FG001|Participant Flow|PF-05089771 450 mg|Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
10895703|NCT00543777|BG000|Baseline|MRE + 2PD MRI|"MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.~Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.~2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue."
10895704|NCT00543777|FG000|Participant Flow|MRE + 2PD MRI|"MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.~Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.~2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue."
10914789|NCT00632749|EG000|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10895705|NCT00543777|OG000|Outcome|MRE + 2PD MRI|"MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.~Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.~2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue."
10895706|NCT00543777|EG000|Reported Event|MRE + 2PD MRI|"MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.~Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.~2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue."
10895707|NCT00543803|BG000|Baseline|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
10895708|NCT00543803|FG000|Participant Flow|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
10895709|NCT00543803|OG000|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
10895710|NCT00543803|OG000|Outcome|Evaluation Assessment at Baseline|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)
11171621|NCT02004366|FG003|Participant Flow|Linagliptin+50%Glargine Dose on d/c|"Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.~Linagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months."
11171622|NCT02004366|FG004|Participant Flow|Linagliptin+80%Glargine Dose on d/c|"Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.~Linagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months."
11171623|NCT02004366|OG000|Outcome|Linagliptin In-hospital|"Linagliptin once daily + correction doses of aspart or lispro if needed.~Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed"
11171624|NCT02004366|OG001|Outcome|Basal Bolus In-hospital|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
11171625|NCT02004366|OG002|Outcome|Linagliptin on Discharge|"Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.~Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months."
10895711|NCT00543803|OG001|Outcome|Last Evaluation Assessment on Treatment|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
10895712|NCT00543803|EG000|Reported Event|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD
10895713|NCT00543855|BG000|Baseline|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
10895714|NCT00543855|BG001|Baseline|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
10895715|NCT00543855|BG002|Baseline|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
10895716|NCT00543855|BG003|Baseline|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
10895717|NCT00543855|BG004|Baseline|Total|Total of all reporting groups
10895718|NCT00543855|FG000|Participant Flow|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
10895719|NCT00543855|FG001|Participant Flow|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
10895720|NCT00543855|FG002|Participant Flow|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks)."
10895721|NCT00543855|FG003|Participant Flow|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
10895722|NCT00543855|OG000|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
10895723|NCT00543855|OG001|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
10895724|NCT00543855|OG002|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
10895725|NCT00543855|OG003|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
10895726|NCT00543855|EG000|Reported Event|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
10895727|NCT00543855|EG001|Reported Event|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
10895728|NCT00543855|EG002|Reported Event|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
11171626|NCT02004366|OG003|Outcome|Linagliptin+50%Glargine Dose on d/c|"Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.~Linagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months."
10895729|NCT00543855|EG003|Reported Event|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
10895730|NCT00543985|BG000|Baseline|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' and VO2 max.
10895731|NCT00543985|FG000|Participant Flow|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
10895732|NCT00543985|OG000|Outcome|Stress Echocardiography|Echocardiogram E/E' measured before and after exercise
10895733|NCT00543985|OG000|Outcome|Stress Echocardiography|Echocardiogram E/E' measured after exercise
10895734|NCT00543985|OG000|Outcome|Stress Echocardiography|"Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.~Stress Echocardiography: Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol."
10895735|NCT00543985|OG000|Outcome|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
10895736|NCT00543985|EG000|Reported Event|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' .
10895737|NCT00544076|BG000|Baseline|Sildenafil Citrate/Mo+Aprostadil/Day|"Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~alprostadil: Given intraurethrally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895738|NCT00544076|BG001|Baseline|Sildenafil Citrate Monthly|"Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895739|NCT00544076|BG002|Baseline|Sildenafil Citrate Monthly Daily Sildenafil Citrate|"Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895740|NCT00544076|BG003|Baseline|Total|Total of all reporting groups
10895741|NCT00544076|FG000|Participant Flow|Sildenafil Citrate/Mo+Aprostadil/Day|"Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~alprostadil: Given intraurethrally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895742|NCT00544076|FG001|Participant Flow|Sildenafil Citrate Monthly|"Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895743|NCT00544076|FG002|Participant Flow|Daily Sildenafil Citrate|"P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895744|NCT00544076|OG000|Outcome|Sildenafil Citrate/Mo+Aprostadil/Day|"Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~alprostadil: Given intraurethrally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
11171627|NCT02004366|OG004|Outcome|Linagliptin+80%Glargine Dose on d/c|"Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.~Linagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months."
10895745|NCT00544076|OG001|Outcome|Sildenafil Citrate Monthly|"Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895746|NCT00544076|OG002|Outcome|Daily Sildenafil Citrate|"Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10914790|NCT00632749|EG001|Reported Event|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10895747|NCT00544076|OG002|Outcome|Daily Sildenafil Citrate|"P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895748|NCT00544076|EG000|Reported Event|Sildenafil Citrate/Mo+Aprostadil/Day|"Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~alprostadil: Given intraurethrally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895749|NCT00544076|EG001|Reported Event|Sildenafil Citrate Monthly|"Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895750|NCT00544076|EG002|Reported Event|Daily Sildenafil Citrate|"Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.~sildenafil citrate: Given orally~robotic-assisted laparoscopic surgery: Undergo prostatectomy~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies"
10895751|NCT00544167|BG000|Baseline|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|Doxorubicin 60mg/m2 IV, Cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 12 weeks followed by 12 weeks of paclitaxel (either 175mg/m2 IV every three weeks or 80mg/m2 IV weekly) and sorafenib 400mg twice daily by mouth (up to a maximum of 1 year).
10895752|NCT00544167|FG000|Participant Flow|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
10895753|NCT00544167|OG000|Outcome|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|
10895754|NCT00544167|EG000|Reported Event|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
10895755|NCT00544440|BG000|Baseline|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
10895756|NCT00544440|FG000|Participant Flow|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
10895757|NCT00544440|OG000|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
10895758|NCT00544440|EG000|Reported Event|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
10895759|NCT00544544|BG000|Baseline|Riluzole|Riluzole 100-200 mg/day
10895760|NCT00544544|FG000|Participant Flow|Riluzole|Riluzole 100-200 mg/day
10895761|NCT00544544|OG000|Outcome|Riluzole|Riluzole 100-200 mg/day
10895762|NCT00544544|EG000|Reported Event|Riluzole|Riluzole 100-200 mg/day
10895763|NCT00544557|BG000|Baseline|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
10895764|NCT00544557|FG000|Participant Flow|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
10895765|NCT00544557|OG000|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
10895766|NCT00544557|EG000|Reported Event|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
10895767|NCT00544648|BG000|Baseline|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
11171628|NCT02004366|OG000|Outcome|Linagliptin In-hospital|"Linagliptin once daily+ correction doses of aspart or lispro if needed~Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed"
10895768|NCT00544648|BG001|Baseline|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
10895769|NCT00544648|BG002|Baseline|Total|Total of all reporting groups
10895770|NCT00544648|FG000|Participant Flow|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
10895771|NCT00544648|FG001|Participant Flow|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
10895772|NCT00544648|OG000|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
10895773|NCT00544648|OG000|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
10895774|NCT00544648|OG000|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 with concurrent radiotherapy
10895775|NCT00544648|OG000|Outcome|Phase I and Phase II|"Phase I-Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.~Phase II-MTD Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.~Phase II-"
10895776|NCT00544648|EG000|Reported Event|Phase I|Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
10895777|NCT00544648|EG001|Reported Event|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
10895778|NCT00544674|BG000|Baseline|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
10895779|NCT00544674|FG000|Participant Flow|PR104|Subjects will receive 1100 mg/m^2 PR-104 intravenously once every 21 days (one cycle). In addition, subjects will undergo positron emission topography (PET) imaging with F-18-Fluoro Misonidazole (FMISO) for the assessment of hypoxia and with F-18-Fluorodeoxyglucose (FDG) for the assessment of glucose metabolism.
10895780|NCT00544674|OG000|Outcome|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
10895781|NCT00544674|EG000|Reported Event|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
10895782|NCT00544713|BG000|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
10895783|NCT00544713|BG001|Baseline|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
10895784|NCT00544713|BG002|Baseline|Total|Total of all reporting groups
10895785|NCT00544713|FG000|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
10895786|NCT00544713|FG001|Participant Flow|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
10895787|NCT00544713|OG000|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
10895788|NCT00544713|OG001|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
10895789|NCT00544713|EG000|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
10895790|NCT00544713|EG001|Reported Event|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
10895791|NCT00544778|BG000|Baseline|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
10895792|NCT00544778|FG000|Participant Flow|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
10895793|NCT00544778|OG000|Outcome|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
10895794|NCT00544778|EG000|Reported Event|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
10895795|NCT00544817|BG000|Baseline|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
10895796|NCT00544817|FG000|Participant Flow|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
10895797|NCT00544817|OG000|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
10895798|NCT00544817|EG000|Reported Event|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
10895799|NCT00544869|BG000|Baseline|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
10895800|NCT00544869|BG001|Baseline|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
10895801|NCT00544869|BG002|Baseline|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
10895802|NCT00544869|BG003|Baseline|Total|Total of all reporting groups
10895803|NCT00544869|FG000|Participant Flow|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
10895804|NCT00544869|FG001|Participant Flow|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
10895805|NCT00544869|FG002|Participant Flow|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
10895806|NCT00544869|OG000|Outcome|Stopped at End of Treatment Period 1|
10895807|NCT00544869|OG001|Outcome|Continued at 15 mg/Day|
10895808|NCT00544869|OG002|Outcome|Dose Escalated to 30 mg/Day|
10895809|NCT00544869|EG000|Reported Event|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
10895810|NCT00544869|EG001|Reported Event|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
10895811|NCT00544869|EG002|Reported Event|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
10895812|NCT00544882|BG000|Baseline|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
10895813|NCT00544882|BG001|Baseline|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
10895814|NCT00544882|BG002|Baseline|Total|Total of all reporting groups
10895815|NCT00544882|FG000|Participant Flow|Run-In Cycle - All Enrolled|After completing screening, all enrolled participants received the same regimen of 150 μg Desogestrel (DSG) /20 μg Ethinyl Estradiol (EE) combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1.
10895816|NCT00544882|FG001|Participant Flow|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
10895817|NCT00544882|FG002|Participant Flow|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
10895818|NCT00544882|OG000|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
10895819|NCT00544882|OG001|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
10895820|NCT00544882|EG000|Reported Event|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
11171629|NCT02004366|EG000|Reported Event|Linagliptin In-hospital|"Linagliptin once daily + correction doses of aspart or lispro if needed.~Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed"
10895821|NCT00544882|EG001|Reported Event|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
10895822|NCT00544908|BG000|Baseline|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
10895823|NCT00544908|FG000|Participant Flow|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
10895824|NCT00544908|OG000|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
10895825|NCT00544908|EG000|Reported Event|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
10895826|NCT00545025|BG000|Baseline|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
10895827|NCT00545025|BG001|Baseline|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
10895828|NCT00545025|BG002|Baseline|Total|Total of all reporting groups
10895829|NCT00545025|FG000|Participant Flow|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
10895830|NCT00545025|FG001|Participant Flow|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
10895831|NCT00545025|OG000|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
10895832|NCT00545025|OG001|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
10895833|NCT00545025|EG000|Reported Event|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine adjuvanted with a full dose of AS03-adjuvant in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03- adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
10895834|NCT00545025|EG001|Reported Event|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
10895835|NCT00545051|BG000|Baseline|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
10895836|NCT00545051|BG001|Baseline|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
10895837|NCT00545051|BG002|Baseline|Total|Total of all reporting groups
10895838|NCT00545051|FG000|Participant Flow|Ibandronate|Participants received 150 milligram (mg) ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 International Units (IU) Vitamin D per day.
10895839|NCT00545051|FG001|Participant Flow|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
10895840|NCT00545051|OG000|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
10895841|NCT00545051|OG001|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
10895842|NCT00545051|EG000|Reported Event|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
10895843|NCT00545051|EG001|Reported Event|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
11171630|NCT02004366|EG001|Reported Event|Basal Bolus In-hospital|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
10895844|NCT00545064|BG000|Baseline|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
10895845|NCT00545064|FG000|Participant Flow|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
10895846|NCT00545064|OG000|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
10895847|NCT00545064|OG001|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
10895848|NCT00545064|OG000|Outcome|Preservative-free COSOPT® at Week 8|
10895849|NCT00545064|EG000|Reported Event|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
10895850|NCT00545077|BG000|Baseline|Arm A: Endocrine Therapy (ET)|"Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.~Letrozole~Fulvestrant"
10895851|NCT00545077|BG001|Baseline|Arm B: ET With Bevacizumab (ET-B)|"Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.~Letrozole~Bevacizumab~Fulvestrant"
10895852|NCT00545077|BG002|Baseline|Total|Total of all reporting groups
10895853|NCT00545077|FG000|Participant Flow|Arm A: Endocrine Therapy (ET)|"Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.~Letrozole~Fulvestrant"
10895854|NCT00545077|FG001|Participant Flow|Arm B: ET With Bevacizumab (ET-B)|"Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.~Letrozole~Bevacizumab~Fulvestrant"
11357452|NCT03757234|BG000|Baseline|Omadacycline 200 iv/200 iv|On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
10895855|NCT00545077|OG000|Outcome|Arm A: Endocrine Therapy (ET)|"Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.~Letrozole~Fulvestrant"
10895856|NCT00545077|OG001|Outcome|Arm B: ET With Bevacizumab (ET-B)|"Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.~Letrozole~Bevacizumab~Fulvestrant"
10895857|NCT00545077|EG000|Reported Event|Arm A: Endocrine Therapy (ET)|"Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.~Letrozole~Fulvestrant"
10895858|NCT00545077|EG001|Reported Event|Arm B: ET With Bevacizumab (ET-B)|"Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.~Letrozole~Bevacizumab~Fulvestrant"
10895859|NCT00545103|BG000|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
10895860|NCT00545103|BG001|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
10895861|NCT00545103|BG002|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
10895862|NCT00545103|BG003|Baseline|Placebo|Placebo administered orally once daily
10895863|NCT00545103|BG004|Baseline|Total|Total of all reporting groups
10895864|NCT00545103|FG000|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
10895865|NCT00545103|FG001|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
10895866|NCT00545103|FG002|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
10895867|NCT00545103|FG003|Participant Flow|Placebo|Placebo administered orally once daily
10895868|NCT00545103|OG000|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
10895869|NCT00545103|OG001|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
10895870|NCT00545103|OG002|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
10895871|NCT00545103|OG003|Outcome|Placebo|Placebo administered orally once daily
10895872|NCT00545103|EG000|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
10895873|NCT00545103|EG001|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
10895874|NCT00545103|EG002|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
10895875|NCT00545103|EG003|Reported Event|Placebo|Placebo administered orally once daily
10895876|NCT00545155|BG000|Baseline|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
10895877|NCT00545155|FG000|Participant Flow|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
10895878|NCT00545155|OG000|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
10895879|NCT00545155|EG000|Reported Event|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
10895880|NCT00545168|BG000|Baseline|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
10895881|NCT00545168|BG001|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
10895882|NCT00545168|BG002|Baseline|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
10895883|NCT00545168|BG003|Baseline|Total|Total of all reporting groups
10895884|NCT00545168|FG000|Participant Flow|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
10895885|NCT00545168|FG001|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
10895886|NCT00545168|FG002|Participant Flow|C - NIX|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
10895887|NCT00545168|OG000|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
10895888|NCT00545168|OG001|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
10895889|NCT00545168|OG000|Outcome|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
10895890|NCT00545168|OG001|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
10895891|NCT00545168|OG002|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
10895892|NCT00545168|EG000|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
10895893|NCT00545168|EG001|Reported Event|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
10895894|NCT00545181|BG000|Baseline|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
10895895|NCT00545181|BG001|Baseline|Metronidazole Alone|Metronidazole antibiotic therapy alone
10895896|NCT00545181|BG002|Baseline|Total|Total of all reporting groups
10895897|NCT00545181|FG000|Participant Flow|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
10895898|NCT00545181|FG001|Participant Flow|Metronidazole Alone|Metronidazole antibiotic therapy alone
10895899|NCT00545181|OG000|Outcome|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
10895900|NCT00545181|OG001|Outcome|Metronidazole Alone|Metronidazole antibiotic therapy alone
10895901|NCT00545181|EG000|Reported Event|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
10895902|NCT00545181|EG001|Reported Event|Metronidazole Alone|Metronidazole antibiotic therapy alone
10895903|NCT00545233|BG000|Baseline|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
10895904|NCT00545233|BG001|Baseline|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
10895905|NCT00545233|BG002|Baseline|Total|Total of all reporting groups
10895906|NCT00545233|FG000|Participant Flow|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
10895907|NCT00545233|FG001|Participant Flow|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
10895908|NCT00545233|OG000|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
10895909|NCT00545233|OG001|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
11233282|NCT02425891|BG000|Baseline|Placebo Plus Nab-Paclitaxel|Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
10895910|NCT00545233|OG000|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of piogliatzone per day orally in the 24 week follow-up period.
10895911|NCT00545233|EG000|Reported Event|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
10895912|NCT00545233|EG001|Reported Event|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
10895913|NCT00545272|BG000|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895914|NCT00545272|BG001|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895915|NCT00545272|BG002|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895916|NCT00545272|BG003|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895917|NCT00545272|BG004|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
10895918|NCT00545272|BG005|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895919|NCT00545272|BG006|Baseline|Total|Total of all reporting groups
10895920|NCT00545272|FG000|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895921|NCT00545272|FG001|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895922|NCT00545272|FG002|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895923|NCT00545272|FG003|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895924|NCT00545272|FG004|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
10895925|NCT00545272|FG005|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895926|NCT00545272|OG000|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895927|NCT00545272|OG001|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
11090472|NCT01529346|FG002|Participant Flow|PF-05089771 1600 mg|Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090473|NCT01529346|FG003|Participant Flow|Ibuprofen|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
10895928|NCT00545272|OG002|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895929|NCT00545272|OG003|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895930|NCT00545272|OG004|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
10895931|NCT00545272|OG005|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895932|NCT00545272|EG000|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
11233283|NCT02425891|BG001|Baseline|Atezolizumab Plus Nab-Paclitaxel|Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
10895933|NCT00545272|EG001|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
11090474|NCT01529346|FG004|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090475|NCT01529346|OG000|Outcome|PF-05089771 150 mg|Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter [mm] on a 100 mm Visual Analog Scale [VAS] pain severity rating scale).
11090476|NCT01529346|OG001|Outcome|PF-05089771 450 mg|Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090477|NCT01529346|OG002|Outcome|PF-05089771 1600 mg|Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090478|NCT01529346|OG003|Outcome|Ibuprofen|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090479|NCT01529346|OG004|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090480|NCT01529346|OG000|Outcome|Ibuprofen|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090481|NCT01529346|EG000|Reported Event|PF-05089771 150 mg|Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter [mm] on a 100 mm Visual Analog Scale [VAS] pain severity rating scale).
11090482|NCT01529346|EG001|Reported Event|PF-05089771 450 mg|Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090483|NCT01529346|EG002|Reported Event|PF-05089771 1600 mg|Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090484|NCT01529346|EG003|Reported Event|Ibuprofen|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11233284|NCT02425891|BG002|Baseline|Total|Total of all reporting groups
10895934|NCT00545272|EG002|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895935|NCT00545272|EG003|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895936|NCT00545272|EG004|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
10895937|NCT00545272|EG005|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10895938|NCT00545298|BG000|Baseline|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
10895939|NCT00545298|BG001|Baseline|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
10895940|NCT00545298|BG002|Baseline|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
10895941|NCT00545298|BG003|Baseline|Total|Total of all reporting groups
10895942|NCT00545298|FG000|Participant Flow|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
10895943|NCT00545298|FG001|Participant Flow|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
10895944|NCT00545298|FG002|Participant Flow|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
10895945|NCT00545298|OG000|Outcome|B - Same Treatment for 6 Weeks|This group received 200ppm NO in Nitrogen delivered constantly to a patch over the wound for 8 hours per day for 6 weeks
10895946|NCT00545298|OG001|Outcome|A - Standard of Care (Control)|Standard of Care - dressings and sustained compression only
10895947|NCT00545298|OG002|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm NO gas 8 hrs / day 1 wk, 20ppm 8 hrs / day 5 weeks. Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
10895948|NCT00545298|OG000|Outcome|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
10895949|NCT00545298|OG001|Outcome|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
10895950|NCT00545298|OG002|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
10895951|NCT00545298|EG000|Reported Event|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
11090485|NCT01529346|EG004|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
11090486|NCT01529385|BG000|Baseline|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
11090487|NCT01529385|BG001|Baseline|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
11090488|NCT01529385|BG002|Baseline|Total|Total of all reporting groups
10895952|NCT00545298|EG001|Reported Event|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
10895953|NCT00545298|EG002|Reported Event|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
10895954|NCT00545363|BG000|Baseline|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake."
10895955|NCT00545363|BG001|Baseline|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
10895956|NCT00545363|BG002|Baseline|Total|Total of all reporting groups
10895957|NCT00545363|FG000|Participant Flow|Bone Marker Feedback (BMF) Participants|"Postmenopausal women received ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, received bone marker feedback (BMF) at Month 3. BMF was given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A BMF-form was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by patient relationship program (PRP), carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake."
10895958|NCT00545363|FG001|Participant Flow|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
10895959|NCT00545363|OG000|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake."
10895960|NCT00545363|OG001|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
10895961|NCT00545363|EG000|Reported Event|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake."
10895962|NCT00545363|EG001|Reported Event|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
10895963|NCT00545402|BG000|Baseline|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
10895964|NCT00545402|BG001|Baseline|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
10895965|NCT00545402|BG002|Baseline|Total|Total of all reporting groups
10895966|NCT00545402|FG000|Participant Flow|Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid|Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve [AUC]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center.
10895967|NCT00545402|FG001|Participant Flow|Fixed-Dose MMF + Tacrolimus + Corticosteroid (CS)|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
10895968|NCT00545402|OG000|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
10895969|NCT00545402|OG001|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
10895970|NCT00545402|EG000|Reported Event|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
11090489|NCT01529385|FG000|Participant Flow|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
11090490|NCT01529385|FG001|Participant Flow|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
11090491|NCT01529385|OG000|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
11233285|NCT02425891|FG000|Participant Flow|Placebo Plus Nab-Paclitaxel|Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
10895971|NCT00545402|EG001|Reported Event|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
10895972|NCT00545441|BG000|Baseline|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
10895973|NCT00545441|BG001|Baseline|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
10895974|NCT00545441|BG002|Baseline|Total|Total of all reporting groups
10895975|NCT00545441|FG000|Participant Flow|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
10895976|NCT00545441|FG001|Participant Flow|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
10895977|NCT00545441|OG000|Outcome|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
10895978|NCT00545441|OG001|Outcome|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
10895979|NCT00545441|EG000|Reported Event|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
10895980|NCT00545441|EG001|Reported Event|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
10895981|NCT00545532|BG000|Baseline|Conventional Dose|Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
10895982|NCT00545532|BG001|Baseline|Double Dose|Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
10895983|NCT00545532|BG002|Baseline|Total|Total of all reporting groups
10895984|NCT00545532|FG000|Participant Flow|Conventional Dose|Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
10895985|NCT00545532|FG001|Participant Flow|Double Dose|Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
10895986|NCT00545532|OG000|Outcome|Conventional Dose|Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
11090492|NCT01529385|OG001|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
11090493|NCT01529385|EG000|Reported Event|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
11090494|NCT01529385|EG001|Reported Event|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
11090495|NCT01529450|BG000|Baseline|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
11090496|NCT01529450|BG001|Baseline|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
11090497|NCT01529450|BG002|Baseline|Total|Total of all reporting groups
11090498|NCT01529450|FG000|Participant Flow|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
11090499|NCT01529450|FG001|Participant Flow|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
11090500|NCT01529450|OG000|Outcome|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
11090501|NCT01529450|OG001|Outcome|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
11090502|NCT01529450|OG000|Outcome|All Participants|Participants received LDE225: 800-mg (4 200-mg capsules/day) capsule
11090503|NCT01529450|EG000|Reported Event|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
11090504|NCT01529450|EG001|Reported Event|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
10895987|NCT00545532|OG001|Outcome|Double Dose|Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
10895988|NCT00545532|OG000|Outcome|Adolescents and Children With Pharmacokinetic Evaluation|This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adolescents (>/=13 years old) over 10 days.
10895989|NCT00545532|OG000|Outcome|Adolescents and Children With Pharmacokinetic Evaluation|This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days.
10895990|NCT00545532|EG000|Reported Event|Conventional Dose|Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
10895991|NCT00545532|EG001|Reported Event|Double Dose|Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
10895992|NCT00545571|BG000|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
10895993|NCT00545571|FG000|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week dose titration period (DTP) to maintain hemoglobin (Hb) concentrations within a country-specific target: 11.0 to 13.0 grams per deciliter (g/dL) in Switzerland and 10.0 to 12.0 g/dL in Austria.
10895994|NCT00545571|OG000|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
11233286|NCT02425891|FG001|Participant Flow|Atezolizumab Plus Nab-Paclitaxel|Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
11233287|NCT02425891|OG000|Outcome|Placebo Plus Nab-Paclitaxel|Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
10895995|NCT00545571|EG000|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
10895996|NCT00545584|BG000|Baseline|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
10895997|NCT00545584|BG001|Baseline|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
10895998|NCT00545584|BG002|Baseline|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
10895999|NCT00545584|BG003|Baseline|Total|Total of all reporting groups
10896000|NCT00545584|FG000|Participant Flow|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
10896001|NCT00545584|FG001|Participant Flow|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
11233288|NCT02425891|OG001|Outcome|Atezolizumab Plus Nab-Paclitaxel|Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
10896002|NCT00545584|FG002|Participant Flow|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
10896003|NCT00545584|OG000|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
10896004|NCT00545584|OG001|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
10896005|NCT00545584|OG002|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
10896006|NCT00545584|EG000|Reported Event|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
10896007|NCT00545584|EG001|Reported Event|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
10896008|NCT00545584|EG002|Reported Event|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
10896009|NCT00545623|BG000|Baseline|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
10896010|NCT00545623|BG001|Baseline|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
10896011|NCT00545623|BG002|Baseline|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
10896012|NCT00545623|BG003|Baseline|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
10896013|NCT00545623|BG004|Baseline|Total|Total of all reporting groups
10896014|NCT00545623|FG000|Participant Flow|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
10896015|NCT00545623|FG001|Participant Flow|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
10896016|NCT00545623|FG002|Participant Flow|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
10896017|NCT00545623|FG003|Participant Flow|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
10896018|NCT00545623|OG000|Outcome|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
10896019|NCT00545623|OG001|Outcome|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
10896020|NCT00545623|OG002|Outcome|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
10896021|NCT00545623|OG003|Outcome|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
10896022|NCT00545623|EG000|Reported Event|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
10896023|NCT00545623|EG001|Reported Event|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
10896024|NCT00545623|EG002|Reported Event|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
10896025|NCT00545623|EG003|Reported Event|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
10896026|NCT00545662|BG000|Baseline|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
10896027|NCT00545662|BG001|Baseline|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
10896028|NCT00545662|BG002|Baseline|Total|Total of all reporting groups
10896029|NCT00545662|FG000|Participant Flow|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
10896030|NCT00545662|FG001|Participant Flow|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
10896031|NCT00545662|OG000|Outcome|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
10896032|NCT00545662|OG001|Outcome|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
10896033|NCT00545662|EG000|Reported Event|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
10896034|NCT00545662|EG001|Reported Event|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
10896035|NCT00545688|BG000|Baseline|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896036|NCT00545688|BG001|Baseline|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896037|NCT00545688|BG002|Baseline|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
10896038|NCT00545688|BG003|Baseline|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
10896039|NCT00545688|BG004|Baseline|Total|Total of all reporting groups
10896040|NCT00545688|FG000|Participant Flow|Trastuzumab + Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab intravenous (IV) infusion at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by 5-fluorouracil 600 mg/m^2 IV, epirubicin 90 mg/m^2 IV, and cyclophosphamide 600 mg/m^2 IV (FEC) on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896041|NCT00545688|FG001|Participant Flow|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896042|NCT00545688|FG002|Participant Flow|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
10896043|NCT00545688|FG003|Participant Flow|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
11233289|NCT02425891|OG000|Outcome|Atezolizumab Plus Nab-Paclitaxel|Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
10896044|NCT00545688|OG000|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896045|NCT00545688|OG001|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896046|NCT00545688|OG002|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
10896047|NCT00545688|OG003|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
10896048|NCT00545688|OG000|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896049|NCT00545688|OG001|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896050|NCT00545688|OG003|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
11357453|NCT03757234|BG001|Baseline|Omadacycline 200 iv/100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
10896051|NCT00545688|EG000|Reported Event|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
10896052|NCT00545688|EG001|Reported Event|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
11233290|NCT02425891|EG000|Reported Event|Atezolizumab (q2w) + Nab-Paclitaxel|Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
10896053|NCT00545688|EG002|Reported Event|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
10896054|NCT00545688|EG003|Reported Event|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
10896055|NCT00545714|BG000|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 mg/m^2 as IV infusion on Day 0 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6 (cycle length = 28 days); fludarabine 25 mg/m^2 on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 on Days 1-3 of each cycle during the Induction Phase. Participants with a PR or CR and appropriate neutrophil conditions received maintenance treatment with rituximab (375 mg/m^2 as IV infusion every 2 months) from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6 of Induction Phase.
10896056|NCT00545714|FG000|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) as intravenous (IV) infusion on Day 0 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6 (cycle length = 28 days); fludarabine 25 mg/m^2 on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 on Days 1-3 of each cycle during the Induction Phase. Participants with a partial response (PR) or complete response (CR) and appropriate neutrophil conditions received maintenance treatment with rituximab (375 mg/m^2 as IV infusion every 2 months) from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6 of Induction Phase.
10896057|NCT00545714|OG000|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 mg/m^2 as IV infusion on Day 0 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6 (cycle length = 28 days); fludarabine 25 mg/m^2 on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 on Days 1-3 of each cycle during the Induction Phase. Participants with a PR or CR and appropriate neutrophil conditions received maintenance treatment with rituximab (375 mg/m^2 as IV infusion every 2 months) from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6 of Induction Phase.
10896058|NCT00545714|EG000|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 mg/m^2 as IV infusion on Day 0 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6 (cycle length = 28 days); fludarabine 25 mg/m^2 on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 on Days 1-3 of each cycle during the Induction Phase. Participants with a PR or CR and appropriate neutrophil conditions received maintenance treatment with rituximab (375 mg/m^2 as IV infusion every 2 months) from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6 of Induction Phase.
10896059|NCT00545740|BG000|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
11171631|NCT02004366|EG002|Reported Event|Linagliptin on Discharge|"Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.~Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months."
10896060|NCT00545740|BG001|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
10896061|NCT00545740|BG002|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
10896062|NCT00545740|BG003|Baseline|Placebo|Placebo administered orally once daily
10896063|NCT00545740|BG004|Baseline|Total|Total of all reporting groups
10896064|NCT00545740|FG000|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
10896065|NCT00545740|FG001|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
10896066|NCT00545740|FG002|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
11233291|NCT02425891|EG001|Reported Event|Placebo (q2w) + Nab-Paclitaxel|Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
10896067|NCT00545740|FG003|Participant Flow|Placebo|Placebo administered orally once daily
10896068|NCT00545740|OG000|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
10896069|NCT00545740|OG001|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
10896070|NCT00545740|OG002|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
10896071|NCT00545740|OG003|Outcome|Placebo|Placebo administered orally once daily
10896072|NCT00545740|EG000|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
10896073|NCT00545740|EG001|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
10896074|NCT00545740|EG002|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
10896075|NCT00545740|EG003|Reported Event|Placebo|Placebo administered orally once daily
10896076|NCT00545753|BG000|Baseline|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse - 1% - no nit combing required
10896077|NCT00545753|BG001|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse - 1% - nit comb regimen required
10896078|NCT00545753|BG002|Baseline|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
10896079|NCT00545753|BG003|Baseline|Total|Total of all reporting groups
11335625|NCT03554005|OG004|Outcome|PEG Interferon Alfa-2b 6 mcg/kg OW|Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10896080|NCT00545753|FG000|Participant Flow|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
11171632|NCT02004366|EG003|Reported Event|Linagliptin+50%Glargine Dose on d/c|"Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.~Linagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months."
11171633|NCT02004366|EG004|Reported Event|Linagliptin+80%Glargine Dose on d/c|"Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.~Linagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months."
10896081|NCT00545753|FG001|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
11335626|NCT03554005|OG005|Outcome|PEG Interferon Alfa-2b 7.5 mcg/kg OW|Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10896082|NCT00545753|FG002|Participant Flow|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
10896083|NCT00545753|OG000|Outcome|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
10896084|NCT00545753|OG001|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
10896085|NCT00545753|OG002|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC)Instructions for Use
10896086|NCT00545753|OG000|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
10896087|NCT00545753|OG001|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
10896088|NCT00545753|EG000|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse - 1% - With or without nit combing
11090505|NCT01529502|BG000|Baseline|Fresh Blood-Old Blood-Old Blood + Inhaled Nitric Oxide|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
10896089|NCT00545753|EG001|Reported Event|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
10896090|NCT00545779|BG000|Baseline|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
10896091|NCT00545779|FG000|Participant Flow|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
10896092|NCT00545779|OG000|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
10896093|NCT00545779|EG000|Reported Event|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
10896094|NCT00545792|BG000|Baseline|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
10896095|NCT00545792|FG000|Participant Flow|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
10896096|NCT00545792|OG000|Outcome|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
10896097|NCT00545792|EG000|Reported Event|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
10896098|NCT00545818|BG000|Baseline|Group-1, Implant Length 6 mm|Subjects treated with OsseoSpeed™ implant, length: 6 mm
10896099|NCT00545818|BG001|Baseline|Group-2, Implant Length 11 mm|Subjects treated with OsseoSpeed™ implant, length: 11 mm
10896100|NCT00545818|BG002|Baseline|Total|Total of all reporting groups
10896101|NCT00545818|FG000|Participant Flow|Group-1, Implant Length 6 mm|Subjects treated with OsseoSpeed™ implant, length: 6 mm
10896102|NCT00545818|FG001|Participant Flow|Group-2, Implant Length 11 mm|Subjects treated with OsseoSpeed™ implant, length: 11 mm
10896103|NCT00545818|OG000|Outcome|Group-1, Implant Length 6 mm|Subjects treated with OsseoSpeed™ implant, length: 6 mm
10896104|NCT00545818|OG001|Outcome|Group-2, Implant Length 11 mm|Subjects treated with OsseoSpeed™ implant, length: 11 mm
10896105|NCT00545818|EG000|Reported Event|Group-1, Implant Length 6 mm|Subjects treated with OsseoSpeed™ implant, length: 6 mm
10896106|NCT00545818|EG001|Reported Event|Group-2, Implant Length 11 mm|Subjects treated with OsseoSpeed™ implant, length: 11 mm
10896107|NCT00545948|BG000|Baseline|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
10896108|NCT00545948|BG001|Baseline|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
10896109|NCT00545948|BG002|Baseline|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.~Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
10896110|NCT00545948|BG003|Baseline|Total|Total of all reporting groups
10896111|NCT00545948|FG000|Participant Flow|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
10896112|NCT00545948|FG001|Participant Flow|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
10914791|NCT00632749|EG002|Reported Event|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10896113|NCT00545948|FG002|Participant Flow|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.~Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
10896114|NCT00545948|OG000|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for primary outcome analysis.
10896115|NCT00545948|OG000|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
10896116|NCT00545948|OG000|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study.
10896117|NCT00545948|OG000|Outcome|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
10896118|NCT00545948|OG001|Outcome|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
10896119|NCT00545948|EG000|Reported Event|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
10896120|NCT00545948|EG001|Reported Event|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
10896121|NCT00545974|BG000|Baseline|Memantine|Memantine 10mg administered orally twice daily
10896122|NCT00545974|BG001|Baseline|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
10896123|NCT00545974|BG002|Baseline|Total|Total of all reporting groups
10896124|NCT00545974|FG000|Participant Flow|Memantine|Memantine 10mg administered orally twice daily
10896125|NCT00545974|FG001|Participant Flow|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
10896126|NCT00545974|OG000|Outcome|Memantine|Memantine 10mg administered orally twice daily
10896127|NCT00545974|OG001|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
10896128|NCT00545974|EG000|Reported Event|Memantine|Memantine 10mg administered orally twice daily
10896129|NCT00545974|EG001|Reported Event|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
10896130|NCT00546000|BG000|Baseline|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
10896131|NCT00546000|FG000|Participant Flow|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
10896132|NCT00546000|OG000|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
10896133|NCT00546000|EG000|Reported Event|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
10896134|NCT00546078|BG000|Baseline|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
10896135|NCT00546078|BG001|Baseline|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
10896136|NCT00546078|BG002|Baseline|Total|Total of all reporting groups
10896137|NCT00546078|FG000|Participant Flow|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
10896138|NCT00546078|FG001|Participant Flow|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
10896139|NCT00546078|OG000|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
10896140|NCT00546078|OG001|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
10896141|NCT00546078|EG000|Reported Event|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
10896142|NCT00546078|EG001|Reported Event|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
10896143|NCT00546104|BG000|Baseline|Dasatinib|50-100mg by mouth twice a day
10896144|NCT00546104|FG000|Participant Flow|Dasatinib|50-100 mg PO BID
10896145|NCT00546104|OG000|Outcome|Dasatinib|50mg-100mg po BID
10896146|NCT00546104|EG000|Reported Event|Dasatinib|50-100mg po bid
10896147|NCT00546117|BG000|Baseline|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
10896148|NCT00546117|BG001|Baseline|Placebo|Placebo SoluTab once daily for 2 months
10896149|NCT00546117|BG002|Baseline|Total|Total of all reporting groups
10896150|NCT00546117|FG000|Participant Flow|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
10896151|NCT00546117|FG001|Participant Flow|Placebo|Placebo SoluTab once daily for 2 months
10896152|NCT00546117|OG000|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
10896153|NCT00546117|OG001|Outcome|Placebo|Placebo SoluTab once daily for 2 months
10896154|NCT00546117|OG000|Outcome|Lansoprazole (Prevacid)|"Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months~lansoprazole: Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing >30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm."
10896155|NCT00546117|OG001|Outcome|Placebo|"Placebo SoluTab once daily for 2 months~placebo: Placebo Solutab in 15 and 30 mg dosages."
10896156|NCT00546117|EG000|Reported Event|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
10896157|NCT00546117|EG001|Reported Event|Placebo|Placebo SoluTab once daily for 2 months
10896158|NCT00546156|BG000|Baseline|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
10896159|NCT00546156|BG001|Baseline|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
10896160|NCT00546156|BG002|Baseline|Total|Total of all reporting groups
10896161|NCT00546156|FG000|Participant Flow|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
10896162|NCT00546156|FG001|Participant Flow|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
10896163|NCT00546156|OG000|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
10896164|NCT00546156|OG001|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
10896165|NCT00546156|EG000|Reported Event|All Study Participants|Patients with HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
10896166|NCT00546260|BG000|Baseline|Placebo|Placebo Comparator
10896167|NCT00546260|BG001|Baseline|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
10896168|NCT00546260|BG002|Baseline|Total|Total of all reporting groups
10896169|NCT00546260|FG000|Participant Flow|Placebo|Placebo Comparator
10896170|NCT00546260|FG001|Participant Flow|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
11090506|NCT01529502|BG001|Baseline|Fresh Blood-Old Blood + Inhaled Nitric Oxide-Old Blood-|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
11090507|NCT01529502|BG002|Baseline|Old Blood- Fresh Blood- Old Blood + Inhaled Nitric Oxide|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
11090508|NCT01529502|BG003|Baseline|Old Blood- Old Blood + Inhaled Nitric Oxide- Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
11171634|NCT02004613|BG000|Baseline|Dexmedetomidine|"Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.~Dexmedetomidine: Dexmedetomidine"
10896171|NCT00546260|OG000|Outcome|Placebo|Placebo Comparator
10896172|NCT00546260|OG001|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
10896173|NCT00546260|EG000|Reported Event|Placebo|Placebo Comparator
10896174|NCT00546260|EG001|Reported Event|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
10896175|NCT00546351|BG000|Baseline|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
10896176|NCT00546351|FG000|Participant Flow|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
10896177|NCT00546351|OG000|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
10896178|NCT00546351|EG000|Reported Event|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
10896179|NCT00546364|BG000|Baseline|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
10896180|NCT00546364|BG001|Baseline|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
10896181|NCT00546364|BG002|Baseline|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
10896182|NCT00546364|BG003|Baseline|Total|Total of all reporting groups
10896183|NCT00546364|FG000|Participant Flow|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
10896184|NCT00546364|FG001|Participant Flow|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
11090509|NCT01529502|BG004|Baseline|Old Blood + Inhaled Nitric Oxide- Fresh Blood- Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
10896185|NCT00546364|FG002|Participant Flow|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
10896186|NCT00546364|OG000|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
10896187|NCT00546364|OG001|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
10896188|NCT00546364|OG002|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
10896189|NCT00546364|EG000|Reported Event|Docetaxel|
10896190|NCT00546364|EG001|Reported Event|Ixabepilone 32|
10896191|NCT00546364|EG002|Reported Event|Ixabepilone 40|
11090510|NCT01529502|BG005|Baseline|Old Blood + Inhaled Nitric Oxide- Old Blood- Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
11090511|NCT01529502|BG006|Baseline|Total|Total of all reporting groups
11090512|NCT01529502|FG000|Participant Flow|Fresh Blood - Old Blood - Old Blood+iNO|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
11090513|NCT01529502|FG001|Participant Flow|Old Blood - Fresh Blood - Old Blood+iNO|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
10914792|NCT00632749|EG003|Reported Event|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11090514|NCT01529502|FG002|Participant Flow|Old Blood+iNO - Old Blood - Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
11171635|NCT02004613|BG001|Baseline|Placebo|"normal saline administration matching dexmedetomidine rate of infusion.~Placebo: Normal saline administration matching dexmedetomidine rate of infusion"
11171636|NCT02004613|BG002|Baseline|Total|Total of all reporting groups
11171637|NCT02004613|FG000|Participant Flow|Dexmedetomidine|"Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.~Dexmedetomidine: Dexmedetomidine"
11171638|NCT02004613|FG001|Participant Flow|Placebo|"normal saline administration matching dexmedetomidine rate of infusion.~Placebo: Normal saline administration matching dexmedetomidine rate of infusion"
10896192|NCT00546377|BG000|Baseline|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
10896193|NCT00546377|FG000|Participant Flow|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
10896194|NCT00546377|OG000|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
10896195|NCT00546377|EG000|Reported Event|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
10896196|NCT00546390|BG000|Baseline|Ischemic Preconditioned Group (rIP)|"A 15-cm sterile blood pressure cuff was placed around the right thigh and connected to the inflating device, and the patient was draped obscuring the visibility of the cuff. Subsequently, the patient was randomly allocated (by opening of an envelope) to RIPC consisting of four 5-min cycles of lower limb ischemia-reperfusion induced by a tourniquet inflated to 300 mmHg~Blood Pressure Cuff: The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row."
11171639|NCT02004613|OG000|Outcome|Dexmedetomidine|"Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.~Dexmedetomidine: Dexmedetomidine"
11171640|NCT02004613|OG001|Outcome|Placebo|"normal saline administration matching dexmedetomidine rate of infusion.~Placebo: Normal saline administration matching dexmedetomidine rate of infusion"
10896197|NCT00546390|BG001|Baseline|Placebo|No rIP as described for rIP group
10896198|NCT00546390|BG002|Baseline|Total|Total of all reporting groups
10896199|NCT00546390|FG000|Participant Flow|Ischemic Preconditioned Group (rIP)|"A 15-cm sterile blood pressure cuff was placed around the right thigh and connected to the inflating device, and the patient was draped obscuring the visibility of the cuff. Subsequently, the patient was randomly allocated (by opening of an envelope) to RIPC consisting of four 5-min cycles of lower limb ischemia-reperfusion induced by a tourniquet inflated to 300 mmHg~Blood Pressure Cuff: The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row."
10896200|NCT00546390|FG001|Participant Flow|Placebo|No rIP - cuff placed but not used - actions by RA as if cuff inflated
10896201|NCT00546390|OG000|Outcome|Ischemic Preconditioned Group (rIP)|"A 15-cm sterile blood pressure cuff was placed around the right thigh and connected to the inflating device, and the patient was draped obscuring the visibility of the cuff. Subsequently, the patient was randomly allocated (by opening of an envelope) to RIPC consisting of four 5-min cycles of lower limb ischemia-reperfusion induced by a tourniquet inflated to 300 mmHg~Blood Pressure Cuff: The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row."
10896202|NCT00546390|OG001|Outcome|Placebo|No cuff inflation
10896203|NCT00546390|OG001|Outcome|Placebo|No rIP - cuff placed but not used - actions by RA as if cuff inflated
10896204|NCT00546390|EG000|Reported Event|Ischemic Preconditioned Group (rIP)|"A 15-cm sterile blood pressure cuff was placed around the right thigh and connected to the inflating device, and the patient was draped obscuring the visibility of the cuff. Subsequently, the patient was randomly allocated (by opening of an envelope) to RIPC consisting of four 5-min cycles of lower limb ischemia-reperfusion induced by a tourniquet inflated to 300 mmHg~Blood Pressure Cuff: The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row."
10896205|NCT00546390|EG001|Reported Event|No Cuff|No rIP
11171641|NCT02004613|EG000|Reported Event|Dexmedetomidine|"Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.~Dexmedetomidine: Dexmedetomidine"
11171642|NCT02004613|EG001|Reported Event|Placebo|"normal saline administration matching dexmedetomidine rate of infusion.~Placebo: Normal saline administration matching dexmedetomidine rate of infusion"
11171643|NCT02004847|BG000|Baseline|High Intensity (HI) vs Control|"PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.~PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
11171644|NCT02004847|BG001|Baseline|Low Intensity (LI) vs Control|"PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.~PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
11171645|NCT02004847|BG002|Baseline|Total|Total of all reporting groups
11171646|NCT02004847|FG000|Participant Flow|High Intensity (HI) vs. Control|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
10896206|NCT00546429|BG000|Baseline|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
10896207|NCT00546429|FG000|Participant Flow|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
10896208|NCT00546429|OG000|Outcome|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
10896209|NCT00546429|EG000|Reported Event|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
10896210|NCT00546481|BG000|Baseline|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
10896211|NCT00546481|BG001|Baseline|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
10896212|NCT00546481|BG002|Baseline|Total|Total of all reporting groups
10896213|NCT00546481|FG000|Participant Flow|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
10896214|NCT00546481|FG001|Participant Flow|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
10896215|NCT00546481|FG002|Participant Flow|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
10896216|NCT00546481|OG000|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
10896217|NCT00546481|OG001|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
11357454|NCT03757234|BG002|Baseline|Omadacycline 200 iv/300 po or 100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
10896218|NCT00546481|OG002|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
10896219|NCT00546481|EG000|Reported Event|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
10896220|NCT00546481|EG001|Reported Event|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
10896221|NCT00546481|EG002|Reported Event|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined protocol) IV once every 4 weeks for the subsequent 24 weeks.
10896222|NCT00546572|BG000|Baseline|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
10896223|NCT00546572|BG001|Baseline|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
10896224|NCT00546572|BG002|Baseline|Total|Total of all reporting groups
10896225|NCT00546572|FG000|Participant Flow|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliters (mL) dose intramuscularly (IM) at Year 0 (vaccination 1 [Vax 1]) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
10896226|NCT00546572|FG001|Participant Flow|23vPS / 13vPnC|23-valent pneumococcal polysaccharide conjugate vaccine (23vPS) 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
10896227|NCT00546572|OG000|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
10896228|NCT00546572|OG001|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
10896229|NCT00546572|OG001|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
10896230|NCT00546572|OG000|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
11171647|NCT02004847|FG001|Participant Flow|Low Intensity (LI) vs. Control|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
10896231|NCT00546572|OG000|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
10896232|NCT00546572|OG001|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
10896233|NCT00546572|OG001|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax )
10896234|NCT00546572|EG000|Reported Event|13vPnC (Vax 1 / Year 0) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=66; systematic (solicited) Local Reactions N=209; systematic (solicited) Systemic Events N=234."
11171648|NCT02004847|OG000|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
11171649|NCT02004847|OG001|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
11171650|NCT02004847|OG000|Outcome|Low Intensity|PSO-CT02 device: Light wavelength 453nm, low intensity
11171651|NCT02004847|OG001|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
10896235|NCT00546572|EG001|Reported Event|23vPS (Vax 1 / Year 0) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=83; systematic (solicited) Local Reactions N=248; systematic (solicited) Systemic Events N=275."
10896236|NCT00546572|EG002|Reported Event|13vPnC 6-M FU (Vax 1 / Year 0)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-Month Follow-up visit (6-M FU) (Vax 1 / Year 0) telephone visit to report new events.
10896237|NCT00546572|EG003|Reported Event|23vPS 6-M FU (Vax 1 / Year 0)|23vPS 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-M FU (Vax 1 / Year 0) telephone visit to report new events.
10896238|NCT00546572|EG004|Reported Event|13vPnC / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=191; systematic (solicited) Systemic Events N=161."
10896239|NCT00546572|EG005|Reported Event|23vPS / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=62; systematic (solicited) Local Reactions N=189; systematic (solicited) Systemic Events N=174."
10896240|NCT00546572|EG006|Reported Event|13vPnC / 13vPnC 6-M FU (Vax 2 / Year 1)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2) ; events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
10896241|NCT00546572|EG007|Reported Event|23vPS / 13vPnC 6-M FU (Vax 2 / Year 1)|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose at Year 1 (Vax 2); events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
10896242|NCT00546637|BG000|Baseline|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
10896243|NCT00546637|BG001|Baseline|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
10896244|NCT00546637|BG002|Baseline|Total|Total of all reporting groups
10896245|NCT00546637|FG000|Participant Flow|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
11171652|NCT02004847|OG001|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
10896246|NCT00546637|FG001|Participant Flow|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
10896247|NCT00546637|OG000|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
10896248|NCT00546637|OG001|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
10896249|NCT00546637|EG000|Reported Event|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
10896250|NCT00546637|EG001|Reported Event|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
10896251|NCT00546715|BG000|Baseline|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
11171653|NCT02004847|OG002|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
11171654|NCT02004847|OG003|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
11171655|NCT02004847|OG000|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
11171656|NCT02004847|OG002|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
10896252|NCT00546715|BG001|Baseline|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896253|NCT00546715|BG002|Baseline|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896254|NCT00546715|BG003|Baseline|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896255|NCT00546715|BG004|Baseline|Total|Total of all reporting groups
10896256|NCT00546715|FG000|Participant Flow|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896257|NCT00546715|FG001|Participant Flow|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896258|NCT00546715|FG002|Participant Flow|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896259|NCT00546715|FG003|Participant Flow|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896260|NCT00546715|OG000|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896261|NCT00546715|OG001|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896262|NCT00546715|OG002|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896263|NCT00546715|OG003|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896264|NCT00546715|EG000|Reported Event|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896265|NCT00546715|EG001|Reported Event|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896266|NCT00546715|EG002|Reported Event|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896267|NCT00546715|EG003|Reported Event|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
10896268|NCT00546728|BG000|Baseline|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
10896269|NCT00546728|BG001|Baseline|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
11171657|NCT02004847|OG003|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient
10896270|NCT00546728|BG002|Baseline|Total|Total of all reporting groups
10896271|NCT00546728|FG000|Participant Flow|Exenatide|Three months of Exenatide. Exenatide was initiated at a dose of 5 mcg, twice a day for one month and up titrated to 10 mcg, twice a day for the remaining two months.
10896272|NCT00546728|FG001|Participant Flow|Metformin|Three months of Metformin. Metformin was initiated at a dose of 500 mg, twice a day for one month and up titrated to 1000 mg, twice a day for the remaining two months.
10896273|NCT00546728|OG000|Outcome|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
10896274|NCT00546728|OG001|Outcome|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
10896275|NCT00546728|EG000|Reported Event|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
10896276|NCT00546728|EG001|Reported Event|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
10896277|NCT00546819|BG000|Baseline|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
10896278|NCT00546819|BG001|Baseline|Placebo|Participants administered Placebo on Day 1.
10896279|NCT00546819|BG002|Baseline|Total|Total of all reporting groups
10896280|NCT00546819|FG000|Participant Flow|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
10896281|NCT00546819|FG001|Participant Flow|Placebo|Participants administered Placebo on Day 1.
10896282|NCT00546819|OG000|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
10896283|NCT00546819|OG001|Outcome|Placebo|Participants administered Placebo on Day 1.
10896284|NCT00546819|EG000|Reported Event|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
10896285|NCT00546819|EG001|Reported Event|Placebo|Participants administered Placebo on Day 1.
10896286|NCT00546871|BG000|Baseline|Treated Participants|
11171658|NCT02004847|OG001|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
11171659|NCT02004847|EG000|Reported Event|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
11171660|NCT02004847|EG001|Reported Event|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
11171661|NCT02004873|BG000|Baseline|Micra Study Enrollments|All subjects enrolled in the Micra study
11171662|NCT02004873|FG000|Participant Flow|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
11171663|NCT02004873|OG000|Outcome|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
11171664|NCT02004873|OG000|Outcome|Micra Subjects With Implant and 6-month PCT Data|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.
11171665|NCT02004873|OG000|Outcome|Micra Subjects With 6-month PCT Data|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.
11171666|NCT02004873|OG000|Outcome|Micra Subjects With Usable M-PREP Data|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.
11171667|NCT02004873|EG000|Reported Event|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
11171668|NCT02004886|BG000|Baseline|MK-0893 (40 mg)|MK-0893 40-mg, once daily
11171669|NCT02004886|BG001|Baseline|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
11171670|NCT02004886|BG002|Baseline|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
11171671|NCT02004886|BG003|Baseline|Placebo|Placebo
11171672|NCT02004886|BG004|Baseline|Total|Total of all reporting groups
11171673|NCT02004886|FG000|Participant Flow|MK-0893 (40 mg)|MK-0893 40-mg, once daily
11171674|NCT02004886|FG001|Participant Flow|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
11171675|NCT02004886|FG002|Participant Flow|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
11171676|NCT02004886|FG003|Participant Flow|Placebo|Placebo
11171677|NCT02004886|OG000|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
11171678|NCT02004886|OG001|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
11171679|NCT02004886|OG002|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
11171680|NCT02004886|OG003|Outcome|Placebo|Placebo
11171681|NCT02004886|EG000|Reported Event|MK-0893 (40 mg)|MK-0893 40-mg, once daily
11171682|NCT02004886|EG001|Reported Event|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
11171683|NCT02004886|EG002|Reported Event|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
11171684|NCT02004886|EG003|Reported Event|Placebo|Placebo
11171685|NCT02004977|BG000|Baseline|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
11171686|NCT02004977|BG001|Baseline|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
11171687|NCT02004977|BG002|Baseline|Total|Total of all reporting groups
10896287|NCT00546871|FG000|Participant Flow|2 to <12 Years|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows: -If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a -If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
10896288|NCT00546871|FG001|Participant Flow|12 Years and Older|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows: -If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a -If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
10896289|NCT00546871|OG000|Outcome|Participants ≥12 Years Old With PK Data Part 1 and Part 3b|"IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the Adjusted Dose. Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an Individually Adapted Dose to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose"
10896290|NCT00546871|OG000|Outcome|Participants Aged 2 to <12 Years|
10896291|NCT00546871|OG000|Outcome|12 Years and Older|
10896292|NCT00546871|OG000|Outcome|All Participants|
10896293|NCT00546871|OG000|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
10896294|NCT00546871|OG001|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
11090515|NCT01529502|FG003|Participant Flow|Fresh Blood - Old Blood+iNO - Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
11090516|NCT01529502|FG004|Participant Flow|Old Blood - Old Blood+iNO - Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
11090517|NCT01529502|FG005|Participant Flow|Old Blood+iNO - Fresh Blood - Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
10896295|NCT00546871|OG000|Outcome|Full Safety Data Set|
10896296|NCT00546871|OG000|Outcome|2 to <12 Years|
10896297|NCT00546871|OG001|Outcome|12 Years and Older|
10896298|NCT00546871|OG000|Outcome|IV Treatment|Study Part 1
10896299|NCT00546871|OG001|Outcome|All SC Treatment Periods|Study Parts 2, 3a, 3b, extension
10896300|NCT00546871|OG000|Outcome|FSDS|All participants who received any study drug
10896301|NCT00546871|OG001|Outcome|SNSC|Dataset of subjects naïve to SC administration of immunoglobulins
10896302|NCT00546871|OG002|Outcome|SESC|Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins
10896303|NCT00546871|OG001|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
10896304|NCT00546871|OG002|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
10896305|NCT00546871|OG000|Outcome|Study Part 1, IV Administration|
10896306|NCT00546871|OG001|Outcome|Study Part 2, SC Administration|
10896307|NCT00546871|OG002|Outcome|Study Part 3a, SC Administration|
10896308|NCT00546871|OG003|Outcome|Study Part 3b, SC Administration|
10896309|NCT00546871|OG004|Outcome|Study Extension, SC Administration|
10896310|NCT00546871|OG005|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
10896311|NCT00546871|OG005|Outcome|Total SC (Study Parts 2, 3a, 3b, Extension)|
11090518|NCT01529502|OG000|Outcome|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
11090519|NCT01529502|OG001|Outcome|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
10896312|NCT00546871|OG000|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
10896313|NCT00546871|OG001|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
10896314|NCT00546871|EG000|Reported Event|IV Treatment Period|Study Part 1
10896315|NCT00546871|EG001|Reported Event|SC Treatment Period|Study Parts 2, 3a, 3b, and Extension
10896316|NCT00546884|BG000|Baseline|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
10896317|NCT00546884|BG001|Baseline|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
10896318|NCT00546884|BG002|Baseline|Total|Total of all reporting groups
10896319|NCT00546884|FG000|Participant Flow|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
11090520|NCT01529502|OG002|Outcome|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
11090521|NCT01529502|EG000|Reported Event|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
10896320|NCT00546884|FG001|Participant Flow|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
10896321|NCT00546884|OG000|Outcome|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
10896322|NCT00546884|OG001|Outcome|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
10896323|NCT00546884|EG000|Reported Event|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
10896324|NCT00546884|EG001|Reported Event|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
10896325|NCT00546897|BG000|Baseline|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
10896326|NCT00546897|BG001|Baseline|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
10896327|NCT00546897|BG002|Baseline|Total|Total of all reporting groups
10896328|NCT00546897|FG000|Participant Flow|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
10896329|NCT00546897|FG001|Participant Flow|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
10896330|NCT00546897|OG000|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
10896331|NCT00546897|OG001|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
10896332|NCT00546897|EG000|Reported Event|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
10896333|NCT00546897|EG001|Reported Event|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
10896334|NCT00546910|BG000|Baseline|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
10896335|NCT00546910|BG001|Baseline|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
10896336|NCT00546910|BG002|Baseline|Total|Total of all reporting groups
10896337|NCT00546910|FG000|Participant Flow|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
11090522|NCT01529502|EG001|Reported Event|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
11090523|NCT01529502|EG002|Reported Event|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
11090524|NCT01529515|BG000|Baseline|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
11090525|NCT01529515|BG001|Baseline|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
11335627|NCT03554005|EG000|Reported Event|PEG Interferon Alfa-2b 0.75 mcg/kg OW|Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10896338|NCT00546910|FG001|Participant Flow|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
10896339|NCT00546910|OG000|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
10896340|NCT00546910|OG001|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
10896341|NCT00546910|EG000|Reported Event|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
10896342|NCT00546910|EG001|Reported Event|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
10896343|NCT00547105|BG000|Baseline|SBRT in Combination With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
10896344|NCT00547105|FG000|Participant Flow|Stereotactic Body Radiation Therapy Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). Stereotactic Body Radiation Therapy (SBRT) will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
11090526|NCT01529515|BG002|Baseline|Total|Total of all reporting groups
11090527|NCT01529515|FG000|Participant Flow|Open-Label Transition Phase: Paliperidone Palmitate 1-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
11090528|NCT01529515|FG001|Participant Flow|Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
10896345|NCT00547105|OG000|Outcome|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
10896346|NCT00547105|EG000|Reported Event|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
10896347|NCT00547118|BG000|Baseline|Rimonabant|"Rimonabant~Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days."
10896348|NCT00547118|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo"
10896349|NCT00547118|BG002|Baseline|Total|Total of all reporting groups
10896350|NCT00547118|FG000|Participant Flow|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
10896351|NCT00547118|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
10896352|NCT00547118|OG000|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
10896353|NCT00547118|OG001|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
10896354|NCT00547118|OG000|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
10896355|NCT00547118|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo"
10896356|NCT00547118|EG000|Reported Event|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
10896357|NCT00547118|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo"
10896358|NCT00547157|BG000|Baseline|Panitumumab Plus Radiotherpy|Consists of Panitumumab and Radiotherpy
10896359|NCT00547157|BG001|Baseline|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
10896360|NCT00547157|BG002|Baseline|Total|Total of all reporting groups
10896361|NCT00547157|FG000|Participant Flow|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
10896362|NCT00547157|FG001|Participant Flow|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
10896363|NCT00547157|OG000|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
10896364|NCT00547157|OG001|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
10896365|NCT00547157|EG000|Reported Event|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
10896366|NCT00547157|EG001|Reported Event|Chemotherapy Plus Radiotherapy|
10896367|NCT00547248|BG000|Baseline|Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group|Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
10896368|NCT00547248|BG001|Baseline|Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group|Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
10896369|NCT00547248|BG002|Baseline|Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
10896370|NCT00547248|BG003|Baseline|Prevenar + Tritanrix - HepB/ Hiberix + Poliorix Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
10896371|NCT00547248|BG004|Baseline|Total|Total of all reporting groups
10896372|NCT00547248|FG000|Participant Flow|Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group|Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
10896373|NCT00547248|FG001|Participant Flow|Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group|Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
10896374|NCT00547248|FG002|Participant Flow|Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
10896375|NCT00547248|FG003|Participant Flow|Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix at 12-18 months of age.
10896376|NCT00547248|OG000|Outcome|Synflorix Pooled Group|Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.
10896377|NCT00547248|OG001|Outcome|Prevenar Pooled Group|Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.
10896378|NCT00547248|OG000|Outcome|Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group|Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
10896379|NCT00547248|OG001|Outcome|Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group|Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
10896380|NCT00547248|OG002|Outcome|Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
10896381|NCT00547248|OG003|Outcome|Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
10896382|NCT00547248|OG002|Outcome|Synflorix + Tritanrix -HepB/ Hiberix + Poliorix™ Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
10896383|NCT00547248|EG000|Reported Event|Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group|Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
10896384|NCT00547248|EG001|Reported Event|Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group|Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
10896385|NCT00547248|EG002|Reported Event|Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
10896386|NCT00547248|EG003|Reported Event|Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group|Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
10896387|NCT00547365|BG000|Baseline|Human Immune Globulin Intravenous (IGIV)|
11090529|NCT01529515|FG002|Participant Flow|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
11357146|NCT03765138|EG000|Reported Event|PE/Pramipexole|"Experimental: Prolonged Exposure (PE)/Pramipexole PE Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. In addition to receiving PE as described above, patients will have Pramipexole treatment.~PE/Pramipexole: Experimental: PE/Pramipexole PE Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation.~Pramipexole: In addition to receiving PE as described above, patients will have Pramipexole treatment. Daily dose will be started at 0.25 mg/day and increased by 0.25 mg/day every 3-4 days to a target of 2.5mg day by week 5. Beginning week 6 daily dose will be increased weekly by 0.5 mg/day to a maximum dose of 4mg. Dose will be increased as tolerated unless the patient has achieved remission and will be decreased in the event of intolerance."
10896388|NCT00547365|FG000|Participant Flow|Human Immune Globulin Intravenous (IGIV)|The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was ~1 yr.
10896389|NCT00547365|OG000|Outcome|Human Immune Globulin Intravenous (IGIV)|Immune globulin intravenous (IGIV) was administered to patients with cardiac-dominant AL amyloidosis in order to determine its therapeutic potential or possible toxicity when given to subjects weekly for 3 months and then every other week for the next 9 months. Response was evaluated by changes in serum anti-fibril antibody levels, changes in BNP (B-type natriuretic peptide) levels and IVS (interventricular septum) thickness.
10896390|NCT00547365|OG000|Outcome|Human Immune Globulin Intravenous (IGIV)|Human immune globulin intravenous (IGIV) was infused into 10 patients with cardiac-associated AL amyloidosis and its therapeutic potential evaluated through measurement of serum anti-fibril IgG antibody levels, as well as amyloid burden, pre- and post-administration.
10896391|NCT00547365|EG000|Reported Event|Human Immune Globulin Intravenous (IGIV)|Therapeutic potential of human immune globulin intravenous (IGIV)in patients with cardiac-associated AL amyloidosis
10896392|NCT00547378|BG000|Baseline|Randomized Cohort: InterStim Therapy|This includes those subjects who were randomized to InterStim Therapy.
10896393|NCT00547378|BG001|Baseline|Randomized Cohort: Standard Medical Therapy|This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant.
10896394|NCT00547378|BG002|Baseline|All Implanted Cohort: Non-randomized Subjects|These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system.
10896395|NCT00547378|BG003|Baseline|Total|Total of all reporting groups
10896396|NCT00547378|FG000|Participant Flow|InterStim Therapy|Randomized Cohort - InterStim Therapy. This includes those subjects who were randomized to InterStim Therapy.
10896397|NCT00547378|FG001|Participant Flow|Standard Medical Therapy|Randomized Cohort - Standard Medical Therapy. This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant.
10896398|NCT00547378|FG002|Participant Flow|All Implanted/Non-Randomized Cohort|These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system.
10896399|NCT00547378|OG000|Outcome|InterStim Therapy|Subjects who were randomized to InterStim Therapy group
10896400|NCT00547378|OG001|Outcome|Standard Medical Therapy|Subjects who were randomized to Standard Medical Therapy group
10896401|NCT00547378|OG000|Outcome|All Implanted Cohort|The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years.
10896402|NCT00547378|EG000|Reported Event|Randomized Cohort: InterStim Therapy Group|Adverse events are summarized for those subjects randomized to the InterStim Therapy group and received full system implant (n=51). Out of 70 subjects, there are 11 subjects who were not implanted with any device component, and 8 subjects who were implanted with lead only, but no neurostimulator. These subjects were not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy.
10896403|NCT00547378|EG001|Reported Event|Randomized Cohort: Standard Medical Therapy Group|Adverse events are summarized for those Subjects randomized are compliant to Standard Medical Therapy group (n=75). Out of 77 subjects, 2 subjects crossovered to InterStim Therapy group and received implant. These subjects are not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy.
10896404|NCT00547378|EG002|Reported Event|All Implanted Cohort|The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years.
10896405|NCT00547521|BG000|Baseline|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
10896406|NCT00547521|BG001|Baseline|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
10896407|NCT00547521|BG002|Baseline|Total|Total of all reporting groups
10896408|NCT00547521|FG000|Participant Flow|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
10896409|NCT00547521|FG001|Participant Flow|SC Abatacept Cohort|In the ST period, participants in this cohort were administered monotherapy, a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE period, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition. LTE period pooled all participants into 1 arm. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
10896410|NCT00547521|OG000|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
10896411|NCT00547521|OG001|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
10896412|NCT00547521|OG000|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator's discretion based upon the participant's clinical status.
11357147|NCT03764449|BG000|Baseline|Cohort 1|Participants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10896413|NCT00547521|OG001|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
10896414|NCT00547521|OG000|Outcome|Abatacept Long Term Extension (LTE) Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
10914793|NCT00632749|EG004|Reported Event|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11357148|NCT03764449|BG001|Baseline|Cohort 2|Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
11357149|NCT03764449|BG002|Baseline|Total|Total of all reporting groups
10896415|NCT00547521|OG000|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
10896416|NCT00547521|OG000|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
10896417|NCT00547521|OG000|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
10896418|NCT00547521|EG000|Reported Event|Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
10896419|NCT00547521|EG001|Reported Event|Short Term Study: SC Abatacept Monotherapy|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
10896420|NCT00547521|EG002|Reported Event|Long Term Extension (LTE):125 mg SC Abatacept|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
10896421|NCT00547534|BG000|Baseline|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
10896422|NCT00547534|FG000|Participant Flow|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
10896423|NCT00547534|OG000|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
10896424|NCT00547534|OG000|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated
10896425|NCT00547534|EG000|Reported Event|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
10896426|NCT00547586|BG000|Baseline|Placebo|placebo: placebo
10896427|NCT00547586|BG001|Baseline|150 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896428|NCT00547586|BG002|Baseline|300 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896429|NCT00547586|BG003|Baseline|450 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896430|NCT00547586|BG004|Baseline|600 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896431|NCT00547586|BG005|Baseline|Total|Total of all reporting groups
10896432|NCT00547586|FG000|Participant Flow|Placebo|placebo: placebo
10896433|NCT00547586|FG001|Participant Flow|150 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896434|NCT00547586|FG002|Participant Flow|300 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896435|NCT00547586|FG003|Participant Flow|450 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896436|NCT00547586|FG004|Participant Flow|600 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896437|NCT00547586|OG000|Outcome|Placebo|placebo: placebo
10896438|NCT00547586|OG001|Outcome|150 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896439|NCT00547586|OG002|Outcome|300 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896440|NCT00547586|OG003|Outcome|450 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896441|NCT00547586|OG004|Outcome|600 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896442|NCT00547586|EG000|Reported Event|Placebo|placebo: placebo
10896443|NCT00547586|EG001|Reported Event|150 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896444|NCT00547586|EG002|Reported Event|300 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896445|NCT00547586|EG003|Reported Event|450 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896446|NCT00547586|EG004|Reported Event|600 mg|N-methylnaltrexone bromide (MOA-728): Oral
10896447|NCT00547638|BG000|Baseline|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application
10896448|NCT00547638|BG001|Baseline|Dermabond HVD|DERMABOND HVD: Comparator Tissue Adhesive for Topical Application
10896449|NCT00547638|BG002|Baseline|Total|Total of all reporting groups
10896450|NCT00547638|FG000|Participant Flow|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
10896451|NCT00547638|FG001|Participant Flow|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
10896452|NCT00547638|OG000|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
10896453|NCT00547638|OG001|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
10896454|NCT00547638|EG000|Reported Event|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
10896455|NCT00547638|EG001|Reported Event|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
10896456|NCT00547703|BG000|Baseline|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
10896457|NCT00547703|BG001|Baseline|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
10896458|NCT00547703|BG002|Baseline|Total|Total of all reporting groups
10896459|NCT00547703|FG000|Participant Flow|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
10896460|NCT00547703|FG001|Participant Flow|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
10896461|NCT00547703|OG000|Outcome|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
10896462|NCT00547703|OG001|Outcome|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
10896463|NCT00547703|EG000|Reported Event|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
10896464|NCT00547703|EG001|Reported Event|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
10896465|NCT00547729|BG000|Baseline|HeartPOD™ System|"Implantation of HeartPOD™ System~HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day."
10896466|NCT00547729|FG000|Participant Flow|HeartPOD™ System|"Implantation of HeartPOD™ System~HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day."
10896467|NCT00547729|OG000|Outcome|HeartPOD™ System|"Implantation of HeartPOD™ System~HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day."
10896468|NCT00547729|EG000|Reported Event|HeartPOD™ System|"Implantation of HeartPOD™ System~HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day."
10896469|NCT00547898|BG000|Baseline|Placebo|Placebo: Placebo
10896470|NCT00547898|BG001|Baseline|Crofelemer 125 mg|Crofelemer 125 mg: Crofelemer 125 mg
10896471|NCT00547898|BG002|Baseline|Crofelemer 250 mg|Crofelemer 250 mg: Crofelemer 250 mg
10896472|NCT00547898|BG003|Baseline|Crofelemer 500 mg|Crofelemer 500 mg: Crofelemer 500 mg
10896473|NCT00547898|BG004|Baseline|Total|Total of all reporting groups
10896474|NCT00547898|FG000|Participant Flow|Placebo|Placebo: Placebo
10896475|NCT00547898|FG001|Participant Flow|Crofelemer 125 mg|Crofelemer 125 mg: Crofelemer 125 mg
10896476|NCT00547898|FG002|Participant Flow|Crofelemer 250 mg|Crofelemer 250 mg: Crofelemer 250 mg
10896477|NCT00547898|FG003|Participant Flow|Crofelemer 500 mg|Crofelemer 500 mg: Crofelemer 500 mg
10896478|NCT00547898|OG000|Outcome|Crofelemer 125Mg BID|
10896479|NCT00547898|OG001|Outcome|Placebo BID|
10896480|NCT00547898|OG000|Outcome|Placebo|Placebo: Placebo
10896481|NCT00547898|OG001|Outcome|Crofelemer 125 mg|Crofelemer 125 mg: Crofelemer 125 mg
10896482|NCT00547898|OG002|Outcome|Crofelemer 250 mg|Crofelemer 250 mg: Crofelemer 250 mg
10896483|NCT00547898|OG003|Outcome|Crofelemer 500 mg|Crofelemer 500 mg: Crofelemer 500 mg
10896484|NCT00547898|EG000|Reported Event|Placebo|Placebo: Placebo
10896485|NCT00547898|EG001|Reported Event|Crofelemer 125 mg|Crofelemer 125 mg: Crofelemer 125 mg
10896486|NCT00547898|EG002|Reported Event|Crofelemer 250 mg|Crofelemer 250 mg: Crofelemer 250 mg
10896487|NCT00547898|EG003|Reported Event|Crofelemer 500 mg|Crofelemer 500 mg: Crofelemer 500 mg
10896488|NCT00547911|BG000|Baseline|Healthy Volunteer|Subjects in good general health
10896489|NCT00547911|BG001|Baseline|Pure Autonomic Failure|Subjects with Pure Autonomic Failure
10896490|NCT00547911|BG002|Baseline|Multiple System Atrophy|Subjects with autonomic failure and a history of Multiple System Atrophy
10896491|NCT00547911|BG003|Baseline|Parkinson's Disease|Subjects with autonomic failure and a history of Parkinson's Disease
10896492|NCT00547911|BG004|Baseline|Total|Total of all reporting groups
10896493|NCT00547911|FG000|Participant Flow|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
10896494|NCT00547911|FG001|Participant Flow|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
10896495|NCT00547911|FG002|Participant Flow|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
10896496|NCT00547911|FG003|Participant Flow|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
10896497|NCT00547911|FG004|Participant Flow|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
10896498|NCT00547911|FG005|Participant Flow|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
10896499|NCT00547911|OG000|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
10896500|NCT00547911|OG001|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
10896501|NCT00547911|OG002|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
10896502|NCT00547911|OG002|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of carbidopa
10896503|NCT00547911|OG001|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of placebo
10896504|NCT00547911|EG000|Reported Event|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
10896505|NCT00547911|EG001|Reported Event|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
10896506|NCT00547911|EG002|Reported Event|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
10896507|NCT00547911|EG003|Reported Event|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
10896508|NCT00547911|EG004|Reported Event|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
10896509|NCT00547911|EG005|Reported Event|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
11171688|NCT02004977|FG000|Participant Flow|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
10896510|NCT00548041|BG000|Baseline|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
10896511|NCT00548041|FG000|Participant Flow|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
10896512|NCT00548041|OG000|Outcome|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
10896513|NCT00548041|EG000|Reported Event|Subjects Undergoing HIV Testing in the ED|
11171689|NCT02004977|FG001|Participant Flow|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
10896514|NCT00548132|BG000|Baseline|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
10896515|NCT00548132|BG001|Baseline|Chlorhexidine-impregnated Foam Dressing|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
10896516|NCT00548132|BG002|Baseline|Total|Total of all reporting groups
10896517|NCT00548132|FG000|Participant Flow|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
10896518|NCT00548132|FG001|Participant Flow|Chlorhexidine-impregnated Foam Dressing|
10896519|NCT00548132|OG000|Outcome|Standard of Care|Standard of care
10896520|NCT00548132|OG001|Outcome|Chlorhexidine Impregnated Sponge|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
10896521|NCT00548132|OG000|Outcome|Standard of Care|Standard catheter care-use of chlorhexidine-alcohol solution to prep the catheter site and then a bioocclusive dressing is applied
10896522|NCT00548132|OG001|Outcome|Intervention Group|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
10896523|NCT00548132|EG000|Reported Event|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
10896524|NCT00548132|EG001|Reported Event|Chlorhexidine-impregnated Foam Dressing|
10896525|NCT00548145|BG000|Baseline|Pitavastatin|2 mg by orally/day Duration: 12 months
10896526|NCT00548145|BG001|Baseline|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
10896527|NCT00548145|BG002|Baseline|Total|Total of all reporting groups
10896528|NCT00548145|FG000|Participant Flow|Pitavastatin|2 mg by orally/day Duration: 12 months
10896529|NCT00548145|FG001|Participant Flow|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
10896530|NCT00548145|OG000|Outcome|Pitavastatin|2 mg by orally/day Duration: 12 months
10896531|NCT00548145|OG001|Outcome|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
10896532|NCT00548145|EG000|Reported Event|Pitavastatin|2 mg by orally/day Duration: 12 months
10896533|NCT00548145|EG001|Reported Event|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
10896534|NCT00548171|BG000|Baseline|Boostrix I Group|Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
10896535|NCT00548171|BG001|Baseline|Boostrix II Group|Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
10896536|NCT00548171|BG002|Baseline|Total|Total of all reporting groups
10896537|NCT00548171|FG000|Participant Flow|Boostrix I Group|Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
10896538|NCT00548171|FG001|Participant Flow|Boostrix II Group|Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
10896539|NCT00548171|OG000|Outcome|Boostrix I Group|Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
10896540|NCT00548171|OG001|Outcome|Boostrix II Group|Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
10896541|NCT00548171|OG000|Outcome|Boostrix Pooled Group|Subjects who had received the Boostrix™ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm.
10896542|NCT00548171|EG000|Reported Event|Boostrix Pooled Group|Subjects who had received the Boostrix™ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm.
10896543|NCT00548184|BG000|Baseline|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
10896544|NCT00548184|FG000|Participant Flow|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and Trastuzumab 4mg/kg loading dose and then 2mg/kg every week
10896545|NCT00548184|OG000|Outcome|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week
10896546|NCT00548184|EG000|Reported Event|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
10896547|NCT00548197|BG000|Baseline|Intervention|"Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy~Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy"
10896548|NCT00548197|BG001|Baseline|Control|no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
10896549|NCT00548197|BG002|Baseline|Total|Total of all reporting groups
10896550|NCT00548197|FG000|Participant Flow|Control Group|no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
10896551|NCT00548197|FG001|Participant Flow|Intervention Group|"Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy~Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy"
10896552|NCT00548197|OG000|Outcome|Intervention|"Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy~Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy"
10896553|NCT00548197|OG001|Outcome|Control|no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
10896554|NCT00548197|OG000|Outcome|Intervention Group|"Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy~Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy"
10896555|NCT00548197|OG001|Outcome|Control Group|no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
10896556|NCT00548197|EG000|Reported Event|Intervention|"Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy~Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy"
10896557|NCT00548197|EG001|Reported Event|Control|no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
10896558|NCT00548249|BG000|Baseline|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896559|NCT00548249|BG001|Baseline|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896560|NCT00548249|BG002|Baseline|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896561|NCT00548249|BG003|Baseline|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896562|NCT00548249|BG004|Baseline|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896563|NCT00548249|BG005|Baseline|Total|Total of all reporting groups
10896564|NCT00548249|FG000|Participant Flow|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896565|NCT00548249|FG001|Participant Flow|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896566|NCT00548249|FG002|Participant Flow|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896567|NCT00548249|FG003|Participant Flow|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896568|NCT00548249|FG004|Participant Flow|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896569|NCT00548249|OG000|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896570|NCT00548249|OG001|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896571|NCT00548249|OG002|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896572|NCT00548249|OG003|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896573|NCT00548249|OG004|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896574|NCT00548249|EG000|Reported Event|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896575|NCT00548249|EG001|Reported Event|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896576|NCT00548249|EG002|Reported Event|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896577|NCT00548249|EG003|Reported Event|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896578|NCT00548249|EG004|Reported Event|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
10896579|NCT00548262|BG000|Baseline|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
10896580|NCT00548262|FG000|Participant Flow|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
10896581|NCT00548262|OG000|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
10896582|NCT00548262|EG000|Reported Event|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
10896583|NCT00548340|BG000|Baseline|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
10896584|NCT00548340|BG001|Baseline|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
10896585|NCT00548340|BG002|Baseline|Placebo|Placebo: Placebo capsules, PO daily for five weeks
10896586|NCT00548340|BG003|Baseline|Total|Total of all reporting groups
10896587|NCT00548340|FG000|Participant Flow|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
10896588|NCT00548340|FG001|Participant Flow|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
10896589|NCT00548340|FG002|Participant Flow|Placebo|Placebo: Placebo capsules, PO daily for five weeks
10896590|NCT00548340|OG000|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
10896591|NCT00548340|OG001|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
10896592|NCT00548340|OG002|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
10896593|NCT00548340|EG000|Reported Event|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
10896594|NCT00548340|EG001|Reported Event|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
10896595|NCT00548340|EG002|Reported Event|Placebo|Placebo: Placebo capsules, PO daily for five weeks
10896596|NCT00548405|BG000|Baseline|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
10896597|NCT00548405|BG001|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
10896598|NCT00548405|BG002|Baseline|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
10896599|NCT00548405|BG003|Baseline|Total|Total of all reporting groups
10896600|NCT00548405|FG000|Participant Flow|Interferon Beta-1a|Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
10896601|NCT00548405|FG001|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
10896602|NCT00548405|FG002|Participant Flow|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
10896603|NCT00548405|OG000|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
10896604|NCT00548405|OG001|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
10896605|NCT00548405|OG000|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
10896606|NCT00548405|EG000|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
10896607|NCT00548405|EG001|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
10896608|NCT00548405|EG002|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
10896609|NCT00548405|EG003|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.
10896610|NCT00548418|BG000|Baseline|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
10896611|NCT00548418|FG000|Participant Flow|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
10896612|NCT00548418|OG000|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
10896613|NCT00548418|EG000|Reported Event|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
10896614|NCT00548431|BG000|Baseline|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
10896615|NCT00548431|FG000|Participant Flow|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
10896616|NCT00548431|OG000|Outcome|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
11357150|NCT03764449|FG000|Participant Flow|Cohort 1|Participants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10896617|NCT00548431|EG000|Reported Event|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
10896618|NCT00548470|BG000|Baseline|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
10896619|NCT00548470|FG000|Participant Flow|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
10896620|NCT00548470|OG000|Outcome|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
10896621|NCT00548470|EG000|Reported Event|Varenicline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
10896622|NCT00548548|BG000|Baseline|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
10896623|NCT00548548|BG001|Baseline|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
10896624|NCT00548548|BG002|Baseline|Total|Total of all reporting groups
10896625|NCT00548548|FG000|Participant Flow|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
10896626|NCT00548548|FG001|Participant Flow|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
10896627|NCT00548548|OG000|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
10896628|NCT00548548|OG001|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
10896629|NCT00548548|EG000|Reported Event|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
11171690|NCT02004977|OG000|Outcome|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
11171691|NCT02004977|OG001|Outcome|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
10896630|NCT00548548|EG001|Reported Event|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
11171692|NCT02004977|EG000|Reported Event|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
10896631|NCT00548652|BG000|Baseline|Usual Care|standard nutrition counselling
10896632|NCT00548652|BG001|Baseline|VA MOVE|"MOVE -weight loss intervention~MOVE: is a VA based multidesciplinary weight loss intervention"
10896633|NCT00548652|BG002|Baseline|Intervention|"MOVE plus methylphenidate~methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid~MOVE: is a VA based multidesciplinary weight loss intervention"
10896634|NCT00548652|BG003|Baseline|Total|Total of all reporting groups
10896635|NCT00548652|FG000|Participant Flow|Usual Care|standard nutrition counselling
10896636|NCT00548652|FG001|Participant Flow|VA MOVE|"MOVE -weight loss intervention~MOVE: is a VA based multidesciplinary weight loss intervention"
10896637|NCT00548652|FG002|Participant Flow|Intervention|"MOVE plus methylphenidate~methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid~MOVE: is a VA based multidesciplinary weight loss intervention"
10896638|NCT00548652|OG000|Outcome|Usual Care|standard nutrition counselling
10896639|NCT00548652|OG001|Outcome|VA MOVE|"MOVE -weight loss intervention~MOVE: is a VA based multidesciplinary weight loss intervention"
11171693|NCT02004977|EG001|Reported Event|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
10896640|NCT00548652|OG002|Outcome|Intervention|"MOVE plus methylphenidate~methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid~MOVE: is a VA based multidesciplinary weight loss intervention"
10896641|NCT00548652|EG000|Reported Event|Usual Care|standard nutrition counselling
10896642|NCT00548652|EG001|Reported Event|VA MOVE|"MOVE -weight loss intervention~MOVE: is a VA based multidesciplinary weight loss intervention"
10896643|NCT00548652|EG002|Reported Event|Intervention|"MOVE plus methylphenidate~methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid~MOVE: is a VA based multidesciplinary weight loss intervention"
10896644|NCT00548691|BG000|Baseline|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
10896645|NCT00548691|BG001|Baseline|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
10896646|NCT00548691|BG002|Baseline|Total|Total of all reporting groups
10896647|NCT00548691|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
10896648|NCT00548691|FG001|Participant Flow|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
10896649|NCT00548691|OG000|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
10896650|NCT00548691|OG001|Outcome|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
10896651|NCT00548691|EG000|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
10896652|NCT00548691|EG001|Reported Event|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
10896653|NCT00548717|BG000|Baseline|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
10896654|NCT00548717|BG001|Baseline|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
10896655|NCT00548717|BG002|Baseline|Total|Total of all reporting groups
10896656|NCT00548717|FG000|Participant Flow|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF)"
10896657|NCT00548717|FG001|Participant Flow|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib for GVHD prophylaxis~Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF) Bortezomib (Velcade)~*Bortezomib added when study reopened in November 2012"
10896658|NCT00548717|OG000|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
10896659|NCT00548717|OG001|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) *added with study reopening in 2012"
10896660|NCT00548717|OG001|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
10896661|NCT00548717|OG000|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
10896662|NCT00548717|OG000|Outcome|Siro /MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
10896663|NCT00548717|OG001|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil,and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
10896664|NCT00548717|EG000|Reported Event|Siro/MMF (+/- Bortezomib)|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis (+/- Bortezomib)~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
10896665|NCT00548808|BG000|Baseline|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
10896666|NCT00548808|BG001|Baseline|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
10896667|NCT00548808|BG002|Baseline|Total|Total of all reporting groups
10896668|NCT00548808|FG000|Participant Flow|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
10896669|NCT00548808|FG001|Participant Flow|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
10896670|NCT00548808|OG000|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
10896671|NCT00548808|OG001|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
10896672|NCT00548808|EG000|Reported Event|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
10896673|NCT00548808|EG001|Reported Event|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
10896674|NCT00548847|BG000|Baseline|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
10896675|NCT00548847|FG000|Participant Flow|GM-CSF, Interferon-α-2b|Granulocyte-macrophage colony-stimulating factor (GM-CSF), Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
10896676|NCT00548847|OG000|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
10896677|NCT00548847|EG000|Reported Event|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
10896678|NCT00548860|BG000|Baseline|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
10896679|NCT00548860|BG001|Baseline|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
10896680|NCT00548860|BG002|Baseline|Total|Total of all reporting groups
10896681|NCT00548860|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
10896682|NCT00548860|FG001|Participant Flow|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
10896683|NCT00548860|OG000|Outcome|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
10896684|NCT00548860|OG001|Outcome|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
10896685|NCT00548860|EG000|Reported Event|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
10896686|NCT00548860|EG001|Reported Event|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
10896687|NCT00549042|BG000|Baseline|OROS Hydromorphone|OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
10896688|NCT00549042|BG001|Baseline|Placebo|Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
10896689|NCT00549042|BG002|Baseline|Total|Total of all reporting groups
10896690|NCT00549042|FG000|Participant Flow|OROS Hydromorphone|OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
10896691|NCT00549042|FG001|Participant Flow|Placebo|Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
10896692|NCT00549042|OG000|Outcome|OROS Hydromorphone|OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
10896693|NCT00549042|OG001|Outcome|Placebo|Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
10896694|NCT00549042|EG000|Reported Event|Conversion and Titration Phase|OROS hydromorphone 12, 16, 24, 32, 40, 48, or 64 m
10896695|NCT00549042|EG001|Reported Event|OROS Hydromorphone|OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
10896696|NCT00549042|EG002|Reported Event|Placebo|Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
10896697|NCT00549055|BG000|Baseline|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
10896698|NCT00549055|FG000|Participant Flow|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
10896699|NCT00549055|OG000|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
10896700|NCT00549055|EG000|Reported Event|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
10896701|NCT00549172|BG000|Baseline|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
10896702|NCT00549172|BG001|Baseline|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
10896703|NCT00549172|BG002|Baseline|Total|Total of all reporting groups
10896704|NCT00549172|FG000|Participant Flow|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
10896705|NCT00549172|FG001|Participant Flow|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
10896706|NCT00549172|OG000|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
10896707|NCT00549172|OG001|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
10896708|NCT00549172|EG000|Reported Event|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus"
10896709|NCT00549172|EG001|Reported Event|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy"
10896710|NCT00549198|BG000|Baseline|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
10896711|NCT00549198|BG001|Baseline|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
10896712|NCT00549198|BG002|Baseline|Total|Total of all reporting groups
10896713|NCT00549198|FG000|Participant Flow|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
10896714|NCT00549198|FG001|Participant Flow|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
10896715|NCT00549198|OG000|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
10896716|NCT00549198|OG001|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
10896717|NCT00549198|EG000|Reported Event|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
10896718|NCT00549198|EG001|Reported Event|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
10896719|NCT00549302|BG000|Baseline|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
10896720|NCT00549302|BG001|Baseline|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
10896721|NCT00549302|BG002|Baseline|Total|Total of all reporting groups
10896722|NCT00549302|FG000|Participant Flow|Tadalafil 20 mg Double Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
10896723|NCT00549302|FG001|Participant Flow|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
10896724|NCT00549302|FG002|Participant Flow|Tadalafil 40 mg Open-Label|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Week 53 up to Week 243.
10896725|NCT00549302|OG000|Outcome|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.
10896726|NCT00549302|OG000|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
10896727|NCT00549302|OG001|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
10896728|NCT00549302|OG000|Outcome|Tadalalfil 20 Milligrams (mg)|Tadalafil, 20 milligram (mg) tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment; LOCF.
10896729|NCT00549302|OG001|Outcome|Tadalafil 40 mg|Tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment.
10896730|NCT00549302|EG000|Reported Event|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg administered orally as 1 tadalafil 20-mg tablet and 1 matched placebo tablet, once daily from Day 1 up to 52 weeks of treatment, or tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Day 1 up to 52 weeks of treatment in Double-Blind Period; and tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Week 53 up to Week 243 in Open-Label Period.
10896731|NCT00549393|BG000|Baseline|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
10896732|NCT00549393|BG001|Baseline|Control Arm|Standard bathing with soap and water basin or disposable cloth
10896733|NCT00549393|BG002|Baseline|Total|Total of all reporting groups
10896734|NCT00549393|FG000|Participant Flow|2% Chlorhexidine Gluconate Cloth|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
10896735|NCT00549393|FG001|Participant Flow|Standard Bath|Standard bathing with soap and water basin or disposable cloth
11090530|NCT01529515|FG003|Participant Flow|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
10896736|NCT00549393|OG000|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
10896737|NCT00549393|OG001|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
10896738|NCT00549393|OG000|Outcome|Treatment|Daily bathing with 2% chlorhexidine gluconate
10896739|NCT00549393|OG001|Outcome|Control|Standard bathing with soap and water basin or disposable cloth
10896740|NCT00549393|EG000|Reported Event|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
10896741|NCT00549393|EG001|Reported Event|Control Arm|Standard bathing with soap and water basin or disposable cloth
10896742|NCT00549445|BG000|Baseline|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.~Azithromycin: 250 mg daily"
10896743|NCT00549445|BG001|Baseline|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.~Placebo: Daily"
10896744|NCT00549445|BG002|Baseline|Total|Total of all reporting groups
10896745|NCT00549445|FG000|Participant Flow|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.~Azithromycin: 250 mg daily"
10896746|NCT00549445|FG001|Participant Flow|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.~Placebo: Daily"
10896747|NCT00549445|OG000|Outcome|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.~Azithromycin: 250 mg daily"
10896748|NCT00549445|OG001|Outcome|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.~Placebo: Daily"
10896749|NCT00549445|EG000|Reported Event|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.~Azithromycin: 250 mg daily"
10896750|NCT00549445|EG001|Reported Event|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.~Placebo: Daily"
10896751|NCT00549549|BG000|Baseline|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
10896752|NCT00549549|BG001|Baseline|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
10896753|NCT00549549|BG002|Baseline|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
10896754|NCT00549549|BG003|Baseline|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
10896755|NCT00549549|BG004|Baseline|Total|Total of all reporting groups
10896756|NCT00549549|FG000|Participant Flow|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
10896757|NCT00549549|FG001|Participant Flow|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
10896758|NCT00549549|FG002|Participant Flow|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
10896759|NCT00549549|FG003|Participant Flow|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
10896760|NCT00549549|OG000|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
10896761|NCT00549549|OG001|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
10896762|NCT00549549|OG002|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
10896763|NCT00549549|OG003|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
10896764|NCT00549549|EG000|Reported Event|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
10896765|NCT00549549|EG001|Reported Event|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
10896766|NCT00549549|EG002|Reported Event|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
10896767|NCT00549549|EG003|Reported Event|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
10896768|NCT00549562|BG000|Baseline|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
10896769|NCT00549562|FG000|Participant Flow|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
10896770|NCT00549562|OG000|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
10896771|NCT00549562|EG000|Reported Event|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
10896772|NCT00549601|BG000|Baseline|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
10896773|NCT00549601|BG001|Baseline|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
10896774|NCT00549601|BG002|Baseline|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
10896775|NCT00549601|BG003|Baseline|Total|Total of all reporting groups
10896776|NCT00549601|FG000|Participant Flow|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
10896777|NCT00549601|FG001|Participant Flow|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
10896778|NCT00549601|FG002|Participant Flow|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
10896779|NCT00549601|OG000|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
10896780|NCT00549601|OG001|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
10896781|NCT00549601|OG002|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
10896782|NCT00549601|OG000|Outcome|Rivastigmine 4.6 mg/9.5 mg Patch|Rivastigmine transdermal patches at increasing doses: Application of one 4.6 mg patch every day for the first month of treatment and thereafter daily application of one 9.5 mg patch for the next two months.
10896783|NCT00549601|OG001|Outcome|Rivastigmine 9.5 mg Patch|Rivastigmine transdermal patches at a constant dose: Application of one 9.5 mg patch every day for the whole treatment period.
10896784|NCT00549601|EG000|Reported Event|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
10896785|NCT00549601|EG001|Reported Event|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
10896786|NCT00549601|EG002|Reported Event|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
10896787|NCT00549640|BG000|Baseline|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
10896788|NCT00549640|BG001|Baseline|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
10896789|NCT00549640|BG002|Baseline|Total|Total of all reporting groups
10896790|NCT00549640|FG000|Participant Flow|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
10896791|NCT00549640|FG001|Participant Flow|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
10896792|NCT00549640|OG000|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
10896793|NCT00549640|OG001|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
10896794|NCT00549640|EG000|Reported Event|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
10896795|NCT00549640|EG001|Reported Event|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
10896796|NCT00549718|BG000|Baseline|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
10896797|NCT00549718|BG001|Baseline|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
10896798|NCT00549718|BG002|Baseline|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
10896799|NCT00549718|BG003|Baseline|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
10896800|NCT00549718|BG004|Baseline|Total|Total of all reporting groups
10896801|NCT00549718|FG000|Participant Flow|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
10896802|NCT00549718|FG001|Participant Flow|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
10896803|NCT00549718|FG002|Participant Flow|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
10896804|NCT00549718|FG003|Participant Flow|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
10896805|NCT00549718|OG000|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
10896806|NCT00549718|OG001|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
10896807|NCT00549718|OG002|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
10896808|NCT00549718|OG003|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
11090531|NCT01529515|OG000|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
10896809|NCT00549718|EG000|Reported Event|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
10896810|NCT00549718|EG001|Reported Event|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
10896811|NCT00549718|EG002|Reported Event|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
10896812|NCT00549718|EG003|Reported Event|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
10896813|NCT00549757|BG000|Baseline|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
10896814|NCT00549757|BG001|Baseline|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
10896815|NCT00549757|BG002|Baseline|Total|Total of all reporting groups
10896816|NCT00549757|FG000|Participant Flow|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
10896817|NCT00549757|FG001|Participant Flow|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
10896818|NCT00549757|OG000|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
10896819|NCT00549757|OG001|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
10896820|NCT00549757|OG001|Outcome|Placebo|In Core (Double Blind) phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
10896821|NCT00549757|OG001|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
10896822|NCT00549757|OG000|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
10896823|NCT00549757|OG001|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
10896824|NCT00549757|EG000|Reported Event|Core-phase: Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
11357151|NCT03764449|FG001|Participant Flow|Cohort 2|Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10896825|NCT00549757|EG001|Reported Event|Core-phase: Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.
10896826|NCT00549757|EG002|Reported Event|Extension-phase: Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
10896827|NCT00549757|EG003|Reported Event|Extension-phase: Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
10896828|NCT00549770|BG000|Baseline|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896829|NCT00549770|BG001|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896830|NCT00549770|BG002|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896831|NCT00549770|BG003|Baseline|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896832|NCT00549770|BG004|Baseline|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896833|NCT00549770|BG005|Baseline|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896834|NCT00549770|BG006|Baseline|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
10896835|NCT00549770|BG007|Baseline|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896836|NCT00549770|BG008|Baseline|Total|Total of all reporting groups
10896837|NCT00549770|FG000|Participant Flow|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896838|NCT00549770|FG001|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896839|NCT00549770|FG002|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896840|NCT00549770|FG003|Participant Flow|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896841|NCT00549770|FG004|Participant Flow|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
11233292|NCT02425956|BG000|Baseline|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
11233293|NCT02425956|FG000|Participant Flow|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
11357152|NCT03764449|OG000|Outcome|Cohort 1|Participants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10896842|NCT00549770|FG005|Participant Flow|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896843|NCT00549770|FG006|Participant Flow|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
10896844|NCT00549770|FG007|Participant Flow|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896845|NCT00549770|OG000|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896846|NCT00549770|OG001|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896847|NCT00549770|OG002|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896848|NCT00549770|OG003|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896849|NCT00549770|OG004|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896850|NCT00549770|OG005|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896851|NCT00549770|OG006|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
10896852|NCT00549770|OG007|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896853|NCT00549770|EG000|Reported Event|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896854|NCT00549770|EG001|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896855|NCT00549770|EG002|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896856|NCT00549770|EG003|Reported Event|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896857|NCT00549770|EG004|Reported Event|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896858|NCT00549770|EG005|Reported Event|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896859|NCT00549770|EG006|Reported Event|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
10896860|NCT00549770|EG007|Reported Event|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
10896861|NCT00549783|BG000|Baseline|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
10896862|NCT00549783|BG001|Baseline|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
10896863|NCT00549783|BG002|Baseline|Total|Total of all reporting groups
10896864|NCT00549783|FG000|Participant Flow|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
10896865|NCT00549783|FG001|Participant Flow|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
10896866|NCT00549783|OG000|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
10896867|NCT00549783|OG001|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
10896868|NCT00549783|EG000|Reported Event|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
10896869|NCT00549783|EG001|Reported Event|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
10896870|NCT00549822|BG000|Baseline|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
10896871|NCT00549822|FG000|Participant Flow|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
10896872|NCT00549822|OG000|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
10896873|NCT00549822|EG000|Reported Event|Intermittent Letrozole Therapy|Letrozole 2.5mg: Intermittently
10896874|NCT00549900|BG000|Baseline|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
10896875|NCT00549900|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
10896876|NCT00549900|OG000|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
10896877|NCT00549900|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
10896878|NCT00549939|BG000|Baseline|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
10896879|NCT00549939|BG001|Baseline|Alfuzosin 0.1 mg/kg/Day|
10896880|NCT00549939|BG002|Baseline|Alfuzosin 0.2 mg/kg/Day|
10896881|NCT00549939|BG003|Baseline|Total|Total of all reporting groups
11090532|NCT01529515|OG001|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
11171694|NCT02004990|BG000|Baseline|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
10896882|NCT00549939|FG000|Participant Flow|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
10896883|NCT00549939|FG001|Participant Flow|Alfuzosin 0.1 mg/kg/Day|
10896884|NCT00549939|FG002|Participant Flow|Alfuzosin 0.2 mg/kg/Day|
10896885|NCT00549939|OG000|Outcome|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
10896886|NCT00549939|OG001|Outcome|Alfuzosin 0.1 mg/kg/Day|
10896887|NCT00549939|OG002|Outcome|Alfuzosin 0.2 mg/kg/Day|
10896888|NCT00549939|OG000|Outcome|Placebo|
10896889|NCT00549939|OG000|Outcome|Alfuzosin 0.1 mg/kg/Day|
10896890|NCT00549939|OG001|Outcome|Alfuzosin 0.2 mg/kg/Day|
10896891|NCT00549939|EG000|Reported Event|Alfuzosin 0.1 mg/kg/Day|
10896892|NCT00549939|EG001|Reported Event|Alfuzosin 0.2 mg/kg/Day|
10896893|NCT00550043|BG000|Baseline|Placebo|
10896894|NCT00550043|BG001|Baseline|Cohort 1: Treatment Group A|INCB018424 15 mg BID
10896895|NCT00550043|BG002|Baseline|Cohort 2: Treatment Group B|INCB018424 5 mg BID
10896896|NCT00550043|BG003|Baseline|Cohort 2: Treatment Group C|INCB018424 25 mg BID
10896897|NCT00550043|BG004|Baseline|Cohort 2: Treatment Group D|INCB018424 50 mg QD
10896898|NCT00550043|BG005|Baseline|Total|Total of all reporting groups
10896899|NCT00550043|FG000|Participant Flow|Placebo|
10896900|NCT00550043|FG001|Participant Flow|Cohort 1: Treatment Group A|INCB018424 15 mg BID
10896901|NCT00550043|FG002|Participant Flow|Cohort 2: Treatment Group B|INCB018424 5 mg BID
10896902|NCT00550043|FG003|Participant Flow|Cohort 2: Treatment Group C|INCB018424 25 mg BID
10896903|NCT00550043|FG004|Participant Flow|Cohort 2: Treatment Group D|INCB018424 50 mg QD
10896904|NCT00550043|OG000|Outcome|Placebo|
10896905|NCT00550043|OG001|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
10896906|NCT00550043|OG002|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
10896907|NCT00550043|OG003|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
10896908|NCT00550043|OG004|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
10896909|NCT00550043|EG000|Reported Event|Placebo|
10896910|NCT00550043|EG001|Reported Event|Cohort 1: Treatment Group A|INCB018424 15 mg BID
10896911|NCT00550043|EG002|Reported Event|Cohort 2: Treatment Group B|INCB018424 5 mg BID
10896912|NCT00550043|EG003|Reported Event|Cohort 2: Treatment Group C|INCB018424 25 mg BID
10896913|NCT00550043|EG004|Reported Event|Cohort 2: Treatment Group D|INCB018424 50 mg QD
10896914|NCT00550147|BG000|Baseline|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
10896915|NCT00550147|FG000|Participant Flow|OROS Methylphenidate and Quetiapine|This is the Baseline Visit, immediately after enrollment and prior to taking any medication. All enrolled subjects start taking OROS methylphenidate until Visit 5. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study; 2 subjects were withdrawn from the study prior to visit 5. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm. Visit 10 is measured at the end of OROS MPH+Quetiapine treatment
10896916|NCT00550147|OG000|Outcome|Baseline|Baseline score at study entry
10896917|NCT00550147|OG001|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
10896918|NCT00550147|OG002|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with combined MPH and quetiapine after Week 13
10896919|NCT00550147|OG000|Outcome|Baseline|Baseline scores at study entry
10896920|NCT00550147|OG002|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
10896921|NCT00550147|OG000|Outcome|Baseline|Baseline scores at Study Entry
10896922|NCT00550147|OG001|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH Monotherapy after Week 4
10896923|NCT00550147|OG002|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
10896924|NCT00550147|OG001|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after week 4
10896925|NCT00550147|OG002|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+Quetiapine after Week 13
10896926|NCT00550147|EG000|Reported Event|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
10896927|NCT00550173|BG000|Baseline|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
10896928|NCT00550173|BG001|Baseline|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
10896929|NCT00550173|BG002|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
10896930|NCT00550173|BG003|Baseline|Total|Total of all reporting groups
10896931|NCT00550173|FG000|Participant Flow|Pemetrexed + Erlotinib|Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
11090533|NCT01529515|EG000|Reported Event|Open-Label Phase: PP1M + PP3M|PP1M= Paliperidone Palmitate 1 Month and PP3M= Paliperidone Palmitate 3 Month. Open-Label Transition Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. Open-Label Maintenance Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
10896932|NCT00550173|FG001|Participant Flow|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
10896933|NCT00550173|FG002|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
10896934|NCT00550173|OG000|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
10896935|NCT00550173|OG001|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
10896936|NCT00550173|OG002|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
10896937|NCT00550173|OG000|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
10896938|NCT00550173|EG000|Reported Event|Pemetrexed + Erlotinib|Participants received pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
10896939|NCT00550173|EG001|Reported Event|Erlotinib|Participants received erlotinib 150 mg, administered orally once daily in each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
10896940|NCT00550173|EG002|Reported Event|Pemetrexed|Participants received pemetrexed 500 mg/m^2 of body surface area, administered by intravenous (IV) infusion on Day 1 of each 21 day cycle until progression or unacceptable toxicity developed up to 39 months.
10896941|NCT00550238|BG000|Baseline|Pimavanserin|Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
10896942|NCT00550238|FG000|Participant Flow|Pimavanserin|Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
10896943|NCT00550238|OG000|Outcome|Pimavanserin|Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
10896944|NCT00550238|EG000|Reported Event|Pimavanserin|Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
10896945|NCT00550277|BG000|Baseline|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10896946|NCT00550277|FG000|Participant Flow|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10896947|NCT00550277|OG000|Outcome|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
11233294|NCT02425956|OG000|Outcome|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
11357153|NCT03764449|OG000|Outcome|Cohort 2|Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10896948|NCT00550277|EG000|Reported Event|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10896949|NCT00550290|BG000|Baseline|24 Hour Post-operative Course of Cefazolin|Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin
10896950|NCT00550290|BG001|Baseline|Pre-operative Single Dose of Cefazolin.|Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
10896951|NCT00550290|BG002|Baseline|Total|Total of all reporting groups
10896952|NCT00550290|FG000|Participant Flow|24 Hour Post-operative Course of Cefazolin|Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin
10896953|NCT00550290|FG001|Participant Flow|Pre-operative Single Dose of Cefazolin.|Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
10896954|NCT00550290|OG000|Outcome|24 Hour Post-operative Course of Cefazolin|Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin
10896955|NCT00550290|OG001|Outcome|Pre-operative Single Dose of Cefazolin.|Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
10896956|NCT00550290|EG000|Reported Event|24 Hour Post-operative Course of Cefazolin|Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin
10896957|NCT00550290|EG001|Reported Event|Pre-operative Single Dose of Cefazolin.|Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
10896958|NCT00550368|BG000|Baseline|H. Pylori Negative|Participants who tested negative for H. pylori infection.
10896959|NCT00550368|BG001|Baseline|H. Pylori Positive|Participants who tested H. pylori positive
10896960|NCT00550368|BG002|Baseline|Total|Total of all reporting groups
10896961|NCT00550368|FG000|Participant Flow|H. Pylori Negative|Participants who tested negative for H. pylori infection.
10896962|NCT00550368|FG001|Participant Flow|H. Pylori Positive|Participants who tested H. pylori positive
10896963|NCT00550368|OG000|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
10896964|NCT00550368|OG001|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
10896965|NCT00550368|EG000|Reported Event|H. Pylori Negative|Participants who tested negative for H. pylori infection.
10896966|NCT00550368|EG001|Reported Event|H. Pylori Positive|Participants who tested H. pylori positive
10896967|NCT00550394|BG000|Baseline|Quitiapine and Placebo|"Quetiapine and Placebo~quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
11090534|NCT01529515|EG001|Reported Event|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
10896968|NCT00550394|BG001|Baseline|Quitiapine andTopiramate|"Quetiapine and Topiramate~Quetiapine andTopiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
10896969|NCT00550394|BG002|Baseline|Total|Total of all reporting groups
10896970|NCT00550394|FG000|Participant Flow|Quetiapine and Placebo|"Quetiapine and Placebo~quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
10896971|NCT00550394|FG001|Participant Flow|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine and Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
10896972|NCT00550394|OG000|Outcome|Quetiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
10896973|NCT00550394|OG001|Outcome|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
10896974|NCT00550394|OG000|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
10896975|NCT00550394|OG001|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
10896976|NCT00550394|EG000|Reported Event|Quetiapine and Placebo|"Quetiapine and Placebo~quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
10896977|NCT00550394|EG001|Reported Event|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
10896978|NCT00550407|BG000|Baseline|Placebo|Matching placebo
10896979|NCT00550407|BG001|Baseline|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
10896980|NCT00550407|BG002|Baseline|Total|Total of all reporting groups
10896981|NCT00550407|FG000|Participant Flow|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
10896982|NCT00550407|FG001|Participant Flow|Placebo|Matching placebo
10896983|NCT00550407|FG002|Participant Flow|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
10896984|NCT00550407|OG000|Outcome|Placebo|Matching placebo
10896985|NCT00550407|OG001|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
10896986|NCT00550407|OG000|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
10896987|NCT00550407|EG000|Reported Event|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
10896988|NCT00550407|EG001|Reported Event|Placebo|Matching placebo
10896989|NCT00550407|EG002|Reported Event|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
10896990|NCT00550420|BG000|Baseline|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
10896991|NCT00550420|FG000|Participant Flow|RSG XR 8 mg|Participants received rosiglitazone extended-release (RSG XR) 4 milligram (mg) tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
10896992|NCT00550420|OG000|Outcome|RSG XR 8mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
11090535|NCT01529515|EG002|Reported Event|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
11171695|NCT02004990|FG000|Participant Flow|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
10896993|NCT00550420|OG000|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
10896994|NCT00550420|OG000|Outcome|RSG XR 8 mg|Participants received RSG XR 4 mg tablet orally once daily for first 4 weeks (W 0 to W 4) of treatment followed by RSG XR 8 mg tablet orally once daily from W 5 to W 104.
10896995|NCT00550420|EG000|Reported Event|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
10896996|NCT00550446|BG000|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
10896997|NCT00550446|BG001|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10896998|NCT00550446|BG002|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10896999|NCT00550446|BG003|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
11233295|NCT02425956|EG000|Reported Event|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
10897000|NCT00550446|BG004|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897001|NCT00550446|BG005|Baseline|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897002|NCT00550446|BG006|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
10897003|NCT00550446|BG007|Baseline|Total|Total of all reporting groups
10897004|NCT00550446|FG000|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
10897005|NCT00550446|FG001|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10897006|NCT00550446|FG002|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897007|NCT00550446|FG003|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897008|NCT00550446|FG004|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897009|NCT00550446|FG005|Participant Flow|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897010|NCT00550446|FG006|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
10897011|NCT00550446|FG007|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897012|NCT00550446|FG008|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897013|NCT00550446|FG009|Participant Flow|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897014|NCT00550446|FG010|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897015|NCT00550446|OG000|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
10897016|NCT00550446|OG001|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10897017|NCT00550446|OG002|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897018|NCT00550446|OG003|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897019|NCT00550446|OG004|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897020|NCT00550446|OG005|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897021|NCT00550446|OG006|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
10897022|NCT00550446|OG001|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897023|NCT00550446|OG002|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10897024|NCT00550446|OG003|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897025|NCT00550446|OG004|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897026|NCT00550446|OG005|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897027|NCT00550446|OG006|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897028|NCT00550446|OG007|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897029|NCT00550446|OG008|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897030|NCT00550446|OG009|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
10897031|NCT00550446|OG010|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897032|NCT00550446|OG006|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 15 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
10897033|NCT00550446|OG004|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 5 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
10897034|NCT00550446|OG003|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Initially CP-690,550 3 mg tablet administered orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10. After Week 12, participants were reassigned CP-690,550 5 mg tablet administered orally twice daily.
10897035|NCT00550446|OG005|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 10 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
10897036|NCT00550446|OG008|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Participants who administered Adalimumab initially were switched to CP-690,550 5 milligram (mg) tablet from Week 12 to Week 24.
10897037|NCT00550446|OG007|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897038|NCT00550446|OG008|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
10897039|NCT00550446|OG009|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897040|NCT00550446|EG000|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
10897041|NCT00550446|EG001|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897042|NCT00550446|EG002|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
10897043|NCT00550446|EG003|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897044|NCT00550446|EG004|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897045|NCT00550446|EG005|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
11233296|NCT02426086|BG000|Baseline|Imetelstat 4.7 mg/kg|Participants received imetelstat 4.7 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end. After the first interim analysis, treatment for all participants was unblinded and participants assigned to the imetelstat 4.7 mg/kg arm could continue with their same imetelstat dose or have it increased to 9.4 mg/kg at the investigator's discretion. After the end of main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
11233297|NCT02426086|BG001|Baseline|Imetelstat 9.4 mg/kg|Participants received imetelstat 9.4 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end. After the end of the main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
10897046|NCT00550446|EG006|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
10897047|NCT00550446|EG007|Reported Event|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897048|NCT00550446|EG008|Reported Event|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in Adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
10897049|NCT00550446|EG009|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
10897050|NCT00550446|EG010|Reported Event|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
11233298|NCT02426086|BG002|Baseline|Total|Total of all reporting groups
10897051|NCT00550459|BG000|Baseline|Placebo|Placebo tablet given once daily for 21 days
10897052|NCT00550459|BG001|Baseline|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
10897053|NCT00550459|BG002|Baseline|Total|Total of all reporting groups
10897054|NCT00550459|FG000|Participant Flow|Placebo|Placebo tablet given once daily for 21 days
10897055|NCT00550459|FG001|Participant Flow|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
10897056|NCT00550459|OG000|Outcome|Placebo|Placebo tablet given once daily for 21 days
10897057|NCT00550459|OG001|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
10897058|NCT00550459|EG000|Reported Event|Placebo|Placebo tablet given once daily for 21 days
10897059|NCT00550459|EG001|Reported Event|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
10897060|NCT00550537|BG000|Baseline|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
10897061|NCT00550537|FG000|Participant Flow|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
10914794|NCT00632749|EG005|Reported Event|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
11090536|NCT01529606|BG000|Baseline|Standard Care|"Fifty five patients were recruited into standard treatment group and they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline.~Composite restoration and tooth cleaning: Standard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction."
11090537|NCT01529606|BG001|Baseline|Plasma Treatment|"Forty seven patients were recruited into plasma treatment group and they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth.~Plasma treatment: plasma treatment after preparation and for caries prevention"
11090538|NCT01529606|BG002|Baseline|Total|Total of all reporting groups
11090539|NCT01529606|FG000|Participant Flow|Standard Care|"Fifty patients will be recruited into standard treatment group and they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline.~Composite restoration and tooth cleaning: Standard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction."
11090540|NCT01529606|FG001|Participant Flow|Plasma Treatment|"Fifty patients will be recruited into plasma treatment group and they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth.~Plasma treatment: plasma treatment after preparation and for caries prevention"
11090541|NCT01529606|OG000|Outcome|Standard Care|"Fifty five patients were recruited into standard treatment group and they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline.~Composite restoration and tooth cleaning: Standard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction."
11090542|NCT01529606|OG001|Outcome|Plasma Treatment|"Forty seven patients were recruited into plasma treatment group and they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth.~Plasma treatment: plasma treatment after preparation and for caries prevention"
11090543|NCT01529606|EG000|Reported Event|Standard Care|"Fifty five patients were recruited into standard treatment group and they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline.~Composite restoration and tooth cleaning: Standard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction."
11090544|NCT01529606|EG001|Reported Event|Plasma Treatment|"Forty seven patients were recruited into plasma treatment group and they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth.~Plasma treatment: plasma treatment after preparation and for caries prevention"
11090545|NCT01529632|BG000|Baseline|QVA149|QVA149 plus placebo once daily for 28 days.
11090546|NCT01529632|BG001|Baseline|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
11090547|NCT01529632|BG002|Baseline|Total|Total of all reporting groups
11090548|NCT01529632|FG000|Participant Flow|QVA149|QVA149 plus placebo once daily for 28 days.
11090549|NCT01529632|FG001|Participant Flow|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
11090550|NCT01529632|OG000|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
11090551|NCT01529632|OG001|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
11090552|NCT01529632|EG000|Reported Event|QVA149|QVA149 plus placebo once daily for 28 days.
11090553|NCT01529632|EG001|Reported Event|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
11090554|NCT01529645|BG000|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
11090555|NCT01529645|BG001|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
11090556|NCT01529645|BG002|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
11090557|NCT01529645|BG003|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090558|NCT01529645|BG004|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090559|NCT01529645|BG005|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090560|NCT01529645|BG006|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
10897062|NCT00550537|OG000|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
10897063|NCT00550537|OG000|Outcome|Patients on Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
10897064|NCT00550537|OG000|Outcome|Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
10897065|NCT00550537|OG000|Outcome|Erlotinib Followed by PC|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
10897066|NCT00550537|OG001|Outcome|Erlotinib Followed by PC+B|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
10897067|NCT00550537|OG002|Outcome|Erlotinib|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
11090561|NCT01529645|BG007|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090562|NCT01529645|BG008|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090563|NCT01529645|BG009|Baseline|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
11090564|NCT01529645|BG010|Baseline|Total|Total of all reporting groups
11090565|NCT01529645|FG000|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
11090566|NCT01529645|FG001|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
11090567|NCT01529645|FG002|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
11090568|NCT01529645|FG003|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on day 1 of this study.
11090569|NCT01529645|FG004|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090570|NCT01529645|FG005|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090571|NCT01529645|FG006|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090572|NCT01529645|FG007|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090573|NCT01529645|FG008|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090574|NCT01529645|FG009|Participant Flow|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
11171696|NCT02004990|OG000|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
10897068|NCT00550537|EG000|Reported Event|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
10897069|NCT00550550|BG000|Baseline|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
10897070|NCT00550550|BG001|Baseline|Placebo|Matching placebo tablet administered sublingually once daily.
10897071|NCT00550550|BG002|Baseline|Total|Total of all reporting groups
10897072|NCT00550550|FG000|Participant Flow|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
10897073|NCT00550550|FG001|Participant Flow|Placebo|Matching placebo tablet administered sublingually once daily.
10897074|NCT00550550|OG000|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
11335628|NCT03554005|EG001|Reported Event|PEG Interferon Alfa-2b 1.5 mcg/kg OW|Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10897075|NCT00550550|OG001|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
10897076|NCT00550550|EG000|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
10897077|NCT00550550|EG001|Reported Event|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
10897078|NCT00550589|BG000|Baseline|Cidofovir|1.0% topical cidofovir cream
10897079|NCT00550589|FG000|Participant Flow|Cidofovir|1.0% topical cidofovir cream
10897080|NCT00550589|OG000|Outcome|Cidofovir|1.0% topical cidofovir cream
10897081|NCT00550589|OG000|Outcome|Cidofovir|1% cidofovir
10897082|NCT00550589|OG000|Outcome|Cidofovir|"1.0% topical cidofovir cream~cidofovir: 1.0% topical cream self-applied once daily for 5 consecutive days, with no treatment for the remaining 9 days (a treatment cycle). Subjects will receive up to 6 cycles of treatment.~DNA methylation analysis: formalin fixed biopsy collected at baseline and 6 weeks after treatment discontinuation~gene expression analysis: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~polymerase chain reaction: performed on punch biopsy specimens collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~biopsy: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~histopathologic examination: Evaluated at baseline and 6 weeks after treatment discontinuation"
10897083|NCT00550589|EG000|Reported Event|Cidofovir|1.0% topical cidofovir cream
10897084|NCT00550615|BG000|Baseline|Phase I Participants|"Dasatinib will be orally administered once daily for 28 day cycles.~There will be three dose cohorts for the Dasatinib in the Phase I portion of this trial. A minimum of three patients will be enrolled into each of the following dose cohorts:~Dose cohort # 1 will be 100 mg per day Dose cohort # 2 will be 150 mg per day Dose cohort # 3 will be 200 mg per day"
10897085|NCT00550615|BG001|Baseline|Phase II Participants|"Dasatinib:~The MTD will be determined in the Phase I portion of this trial. An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I."
10897086|NCT00550615|BG002|Baseline|Total|Total of all reporting groups
10897087|NCT00550615|FG000|Participant Flow|Phase I Dose Cohort # 1 (100 mg Per Day)|Dasatinib will be orally administered once daily for 28 day cycles.
10897088|NCT00550615|FG001|Participant Flow|Phase I Dose Cohort # 2 (150 mg Per Day)|Dasatinib will be orally administered once daily for 28 day cycles.
10897089|NCT00550615|FG002|Participant Flow|Phase I Dose Cohort # 3 (200 mg Per Day)|Dasatinib will be orally administered once daily for 28 day cycles.
10897090|NCT00550615|FG003|Participant Flow|Phase II Participants|"Dasatinib:~No DLT was encountered and hence the MTD was determined to be 200 mg PO daily. This was subsequently reduced to 150 mg PO daily when a higher incidence of grade 3 pleural effusions was noted."
10897091|NCT00550615|OG000|Outcome|All Phase I Participants|All participants who enrolled and treated with a minimum of 1 cycle of Dasatinib.
10897092|NCT00550615|OG000|Outcome|Evauable Participants From Both Phases of the Trial|Response assessment was analyzed for both phases of the trial combined.
10897093|NCT00550615|EG000|Reported Event|Phase I Participants|All participants that were dose were monitored for adverse events.
10897094|NCT00550615|EG001|Reported Event|Phase II Participants|All participants that were dose were monitored for adverse events.
10897095|NCT00550654|BG000|Baseline|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
10897096|NCT00550654|FG000|Participant Flow|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
10897097|NCT00550654|OG000|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
10897098|NCT00550654|EG000|Reported Event|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
11090575|NCT01529645|OG000|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
11090576|NCT01529645|OG001|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
11090577|NCT01529645|OG002|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
11090578|NCT01529645|OG003|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
10897099|NCT00550680|BG000|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
10897100|NCT00550680|FG000|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
10897101|NCT00550680|OG000|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
10897102|NCT00550680|EG000|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
10897103|NCT00550732|BG000|Baseline|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
10897104|NCT00550732|FG000|Participant Flow|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
10897105|NCT00550732|OG000|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
10897106|NCT00550732|OG000|Outcome|Prosaconazole|Posaconazole oral suspension was administered as 400 mg BID with food or 200 mg QID without food for a minimum of one month.
10897107|NCT00550732|EG000|Reported Event|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
10897108|NCT00550745|BG000|Baseline|ZOSTAVAX™|"Represents the number of subjects according to the treatment (ZOSTAVAX™) received.~Excludes subjects who were not vaccinated."
10897109|NCT00550745|BG001|Baseline|Placebo|"Represents the number of subjects according to the treatment (placebo) received.~Excludes subjects who were not vaccinated."
10897110|NCT00550745|BG002|Baseline|Total|Total of all reporting groups
10897111|NCT00550745|FG000|Participant Flow|ZOSTAVAX™|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
10897112|NCT00550745|FG001|Participant Flow|Placebo|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
10897113|NCT00550745|OG000|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
10897114|NCT00550745|OG001|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
10897115|NCT00550745|EG000|Reported Event|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (Zostavax™) and had safety follow-up.
10897116|NCT00550745|EG001|Reported Event|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
10897117|NCT00550771|BG000|Baseline|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
10897118|NCT00550771|BG001|Baseline|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
10897119|NCT00550771|BG002|Baseline|Total|Total of all reporting groups
10897120|NCT00550771|FG000|Participant Flow|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
10897121|NCT00550771|FG001|Participant Flow|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
10897122|NCT00550771|OG000|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
10897123|NCT00550771|OG001|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
10897124|NCT00550771|EG000|Reported Event|PLD Based Regimen|
10897125|NCT00550771|EG001|Reported Event|Doxorubicin Based Regimen|
10897126|NCT00550836|BG000|Baseline|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
10897127|NCT00550836|BG001|Baseline|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
10897128|NCT00550836|BG002|Baseline|Total|Total of all reporting groups
10897129|NCT00550836|FG000|Participant Flow|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
10897130|NCT00550836|FG001|Participant Flow|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
10897131|NCT00550836|OG000|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
10897132|NCT00550836|OG001|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
10897133|NCT00550836|EG000|Reported Event|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
10897134|NCT00550836|EG001|Reported Event|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
10897135|NCT00550862|BG000|Baseline|INT-747 10 mg|
10897136|NCT00550862|BG001|Baseline|INT-747 25 mg|
10897137|NCT00550862|BG002|Baseline|INT-747 50 mg|
10897138|NCT00550862|BG003|Baseline|Placebo|
10897139|NCT00550862|BG004|Baseline|Total|Total of all reporting groups
10897140|NCT00550862|FG000|Participant Flow|INT-747 10 mg|
10897141|NCT00550862|FG001|Participant Flow|INT-747 25 mg|
10897142|NCT00550862|FG002|Participant Flow|INT-747 50 mg|
10897143|NCT00550862|FG003|Participant Flow|Placebo|
10897144|NCT00550862|OG000|Outcome|INT-747 10 mg|
10897145|NCT00550862|OG001|Outcome|INT-747 25 mg|
10897146|NCT00550862|OG002|Outcome|INT-747 50 mg|
10897147|NCT00550862|OG003|Outcome|Placebo|
10897148|NCT00550862|EG000|Reported Event|INT-747 10 mg|
10897149|NCT00550862|EG001|Reported Event|INT-747 25 mg|
10897150|NCT00550862|EG002|Reported Event|INT-747 50 mg|
10897151|NCT00550862|EG003|Reported Event|Placebo|
10897152|NCT00550953|BG000|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
10897153|NCT00550953|BG001|Baseline|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
10897154|NCT00550953|BG002|Baseline|Total|Total of all reporting groups
10897155|NCT00550953|FG000|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
10897156|NCT00550953|FG001|Participant Flow|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
10897157|NCT00550953|OG000|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
10897158|NCT00550953|OG001|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
10897159|NCT00550953|EG000|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
10897160|NCT00550953|EG001|Reported Event|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
10897161|NCT00551031|BG000|Baseline|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
10897162|NCT00551031|BG001|Baseline|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
10897163|NCT00551031|BG002|Baseline|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
10897164|NCT00551031|BG003|Baseline|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
10897165|NCT00551031|BG004|Baseline|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
10897166|NCT00551031|BG005|Baseline|Total|Total of all reporting groups
10897167|NCT00551031|FG000|Participant Flow|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
10897168|NCT00551031|FG001|Participant Flow|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
10897169|NCT00551031|FG002|Participant Flow|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
10897170|NCT00551031|FG003|Participant Flow|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
10897171|NCT00551031|FG004|Participant Flow|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
10897172|NCT00551031|OG000|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
11171697|NCT02004990|EG000|Reported Event|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
11171698|NCT02005016|BG000|Baseline|Behavioral Therapy|"All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.~Naming therapy: Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day)."
10897173|NCT00551031|OG001|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
10897174|NCT00551031|OG002|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
10897175|NCT00551031|OG003|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
10897176|NCT00551031|OG004|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
10897177|NCT00551031|EG000|Reported Event|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
10897178|NCT00551031|EG001|Reported Event|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
10897179|NCT00551031|EG002|Reported Event|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
10897180|NCT00551031|EG003|Reported Event|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
10897181|NCT00551031|EG004|Reported Event|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
10897182|NCT00551070|BG000|Baseline|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
10897183|NCT00551070|FG000|Participant Flow|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
10897184|NCT00551070|OG000|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
10897185|NCT00551070|EG000|Reported Event|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
10897186|NCT00551135|BG000|Baseline|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
10897187|NCT00551135|BG001|Baseline|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
10897188|NCT00551135|BG002|Baseline|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
10897189|NCT00551135|BG003|Baseline|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
10897190|NCT00551135|BG004|Baseline|Total|Total of all reporting groups
10897191|NCT00551135|FG000|Participant Flow|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
10897192|NCT00551135|FG001|Participant Flow|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
10897193|NCT00551135|FG002|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
10897194|NCT00551135|FG003|Participant Flow|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
10897195|NCT00551135|OG000|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
10897196|NCT00551135|OG001|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
10897197|NCT00551135|OG002|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
10897198|NCT00551135|OG003|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
10897199|NCT00551135|EG000|Reported Event|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
10897200|NCT00551135|EG001|Reported Event|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
10897201|NCT00551135|EG002|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
10897202|NCT00551135|EG003|Reported Event|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
10897203|NCT00551161|BG000|Baseline|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
10897204|NCT00551161|FG000|Participant Flow|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
10897205|NCT00551161|OG000|Outcome|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
10897206|NCT00551161|EG000|Reported Event|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
10897207|NCT00551174|BG000|Baseline|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
10897208|NCT00551174|BG001|Baseline|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
10897209|NCT00551174|BG002|Baseline|Total|Total of all reporting groups
10897210|NCT00551174|FG000|Participant Flow|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
10897211|NCT00551174|FG001|Participant Flow|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
10897212|NCT00551174|OG000|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
10897213|NCT00551174|OG001|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
10897214|NCT00551174|EG000|Reported Event|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
11357154|NCT03764449|OG001|Outcome|Cohort 2|Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10897215|NCT00551174|EG001|Reported Event|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
10897216|NCT00551200|BG000|Baseline|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
10897217|NCT00551200|FG000|Participant Flow|Buphenyl to HPN-100|HPN-100 : Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study, and then switched over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 was increased and the dose of Buphenyl® was decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate was HPN-100. Target HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week and then switched back to previous dose of Buphenyl for the last week of the study.
10897218|NCT00551200|OG000|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
10897219|NCT00551200|OG001|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
10897220|NCT00551200|OG000|Outcome|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
10897221|NCT00551200|OG000|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
10897222|NCT00551200|OG001|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrates as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
10897223|NCT00551200|OG001|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
10897224|NCT00551200|EG000|Reported Event|Buphenyl|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
10897225|NCT00551200|EG001|Reported Event|HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
10897226|NCT00551213|BG000|Baseline|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
11335629|NCT03554005|EG002|Reported Event|PEG Interferon Alfa-2b 3 mcg/kg OW|Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10897227|NCT00551213|BG001|Baseline|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
10897228|NCT00551213|BG002|Baseline|Total|Total of all reporting groups
10897229|NCT00551213|FG000|Participant Flow|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
10897230|NCT00551213|FG001|Participant Flow|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
10897231|NCT00551213|OG000|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
10897232|NCT00551213|OG001|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
10897233|NCT00551213|EG000|Reported Event|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
10897234|NCT00551213|EG001|Reported Event|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
10897235|NCT00551291|BG000|Baseline|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
10897236|NCT00551291|FG000|Participant Flow|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
10897237|NCT00551291|OG000|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
10897238|NCT00551291|EG000|Reported Event|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
10897239|NCT00551369|BG000|Baseline|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
10897240|NCT00551369|FG000|Participant Flow|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
10897241|NCT00551369|OG000|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
11335630|NCT03554005|EG003|Reported Event|PEG Interferon Alfa-2b 4.5 mcg/kg OW|Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10897242|NCT00551369|EG000|Reported Event|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
10897243|NCT00551421|BG000|Baseline|Pertuzumab and Cetuximab|Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10897244|NCT00551421|FG000|Participant Flow|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: irinotecan hydrochloride, pertuzumab, cetuximab~Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
10897245|NCT00551421|OG000|Outcome|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: irinotecan hydrochloride, pertuzumab, cetuximab~Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
11090579|NCT01529645|OG004|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
10897246|NCT00551421|OG000|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
10897247|NCT00551421|EG000|Reported Event|Pertuzumab and Cetuximab|"Original Protocol: Patients received pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose on cycle 1, day 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as the Original Protocol (see above) except the Cetuximab loading dose was no longer given on cycle 1, day 2 (maintainance dose given).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: pertuzumab, cetuximab, irinotecan hydrochloride~Corrlateive studies: immunohistochemistry staining method, fluorescence in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction, laboratory biomarker analysis"
10897248|NCT00551460|BG000|Baseline|ATRA + GO + Arsenic|Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
10897249|NCT00551460|FG000|Participant Flow|ATRA + GO + Arsenic|"Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR~Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest~Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3~Consolidation 5 and 6: GO 9mg/m2 IV D1~Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year"
10897250|NCT00551460|OG000|Outcome|ATRA + GO + Arsenic|Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
10897251|NCT00551460|EG000|Reported Event|ATRA + GO + Arsenic|Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR
10914795|NCT00632749|EG006|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914796|NCT00632749|EG007|Reported Event|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914797|NCT00632749|EG008|Reported Event|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914798|NCT00632749|EG009|Reported Event|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914799|NCT00632749|EG010|Reported Event|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914800|NCT00632749|EG011|Reported Event|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914801|NCT00632749|EG012|Reported Event|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914802|NCT00632749|EG013|Reported Event|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
10914803|NCT00632814|BG000|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
10897252|NCT00551525|BG000|Baseline|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
10897253|NCT00551525|FG000|Participant Flow|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
10897254|NCT00551525|OG000|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
10897255|NCT00551525|EG000|Reported Event|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
10897256|NCT00551642|BG000|Baseline|Inhaled Nitric Oxide (INO)|INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up
10897257|NCT00551642|BG001|Baseline|Placebo|Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
10897258|NCT00551642|BG002|Baseline|Total|Total of all reporting groups
11171699|NCT02005016|FG000|Participant Flow|Behavioral Therapy|"All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.~Naming therapy: Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day)."
11335631|NCT03554005|EG004|Reported Event|PEG Interferon Alfa-2b 6 mcg/kg OW|Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10897259|NCT00551642|FG000|Participant Flow|Inhaled Nitric Oxide (INO)|INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up
10897260|NCT00551642|FG001|Participant Flow|Placebo|Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
10897261|NCT00551642|OG000|Outcome|Inhaled Nitric Oxide (INO)|INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up
10897262|NCT00551642|OG001|Outcome|Placebo|Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
10897263|NCT00551642|EG000|Reported Event|Inhaled Nitric Oxide (INO)|INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up
10897264|NCT00551642|EG001|Reported Event|Placebo|Placebo gas administered by nasal continuous positive airway pressure (nasal cannula or face mask) for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
10897265|NCT00551707|BG000|Baseline|CRx-102 (2.7/180)|Crx-102 (Dose 1) 2.7 mg prednisolone plus 180 mg dipyridamole
10897266|NCT00551707|BG001|Baseline|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
10897267|NCT00551707|BG002|Baseline|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
10897268|NCT00551707|BG003|Baseline|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (180 mg or 360 mg)"
10897269|NCT00551707|BG004|Baseline|Placebo|"placebo~placebo: placebo"
10897270|NCT00551707|BG005|Baseline|Total|Total of all reporting groups
10897271|NCT00551707|FG000|Participant Flow|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
10897272|NCT00551707|FG001|Participant Flow|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
10897273|NCT00551707|FG002|Participant Flow|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
10897274|NCT00551707|FG003|Participant Flow|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (360 mg)"
10897275|NCT00551707|FG004|Participant Flow|Placebo|"placebo~placebo: placebo"
10897276|NCT00551707|OG000|Outcome|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
10897277|NCT00551707|OG001|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
10897278|NCT00551707|OG002|Outcome|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
10897279|NCT00551707|OG003|Outcome|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (360 mg)"
10897280|NCT00551707|OG004|Outcome|Placebo|"placebo~placebo: placebo"
10897281|NCT00551707|OG000|Outcome|CRx-102 (2.7/180)|"Crx-102 (Dose 1)~2.7 mg prednisolone plus 180 mg dipyridamole"
10897282|NCT00551707|OG003|Outcome|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole 360 mg"
10897283|NCT00551707|EG000|Reported Event|CRx-102 (Dose 1)|"Crx-102 (Dose 1)~CRx-102: prednisolone + dipyridamole"
10897284|NCT00551707|EG001|Reported Event|CRx-102 (Dose 2)|"Crx-102 (Dose 2)~CRx-102: prednisolone + dipyridamole"
10897285|NCT00551707|EG002|Reported Event|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
10897286|NCT00551707|EG003|Reported Event|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (180 mg or 360 mg)"
10897287|NCT00551707|EG004|Reported Event|Placebo|"placebo~placebo: placebo"
10897288|NCT00551746|BG000|Baseline|Grape Juice|100% Grape Juice
10897289|NCT00551746|BG001|Baseline|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
10897290|NCT00551746|BG002|Baseline|Total|Total of all reporting groups
10897291|NCT00551746|FG000|Participant Flow|Grape Juice|100% Grape Juice
10897292|NCT00551746|FG001|Participant Flow|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
10897293|NCT00551746|OG000|Outcome|Purple Grape Juice|100% grape juice
10897294|NCT00551746|OG001|Outcome|Placebo|Taste, color, and colorically matched grape juice placebo
10897295|NCT00551746|EG000|Reported Event|Grape Juice|100% Grape Juice
10897296|NCT00551746|EG001|Reported Event|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
10897297|NCT00551759|BG000|Baseline|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
10897298|NCT00551759|FG000|Participant Flow|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
10897299|NCT00551759|OG000|Outcome|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
10897300|NCT00551759|EG000|Reported Event|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab.
10897301|NCT00552058|BG000|Baseline|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
10897302|NCT00552058|BG001|Baseline|Placebo|Placebo, saline solution for sc injection
10897303|NCT00552058|BG002|Baseline|Total|Total of all reporting groups
10897304|NCT00552058|FG000|Participant Flow|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
10897305|NCT00552058|FG001|Participant Flow|Placebo|Placebo, saline solution for sc injection
10897306|NCT00552058|OG000|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
10897307|NCT00552058|OG001|Outcome|Placebo|Placebo, saline solution for sc injection
10897308|NCT00552058|EG000|Reported Event|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
10897309|NCT00552058|EG001|Reported Event|Placebo|Placebo, saline solution for sc injection
10897310|NCT00552071|BG000|Baseline|Ultrasound-guided Injections Followed by Regular Injections|Subjects received octreotide LAR via ultrasound-guided IM gluteal injections every 28 days for 3 months followed by regular IM gluteal injections every 28 days for 3 months.
10897311|NCT00552071|BG001|Baseline|Regular Injections Followed by Ultrasound-guided Injections|Subjects received octreotide LAR via regular IM gluteal injections every 28 days for 3 months followed by ultrasound-guided IM gluteal injections every 28 days for 3 months.
10897312|NCT00552071|BG002|Baseline|Total|Total of all reporting groups
10897313|NCT00552071|FG000|Participant Flow|Ultrasound-guided Injections Followed by Regular Injections|Subjects received octreotide LAR via ultrasound-guided IM gluteal injections every 28 days for 3 months followed by regular IM gluteal injections every 28 days for 3 months.
10897314|NCT00552071|FG001|Participant Flow|Regular Injections Followed by Ultrasound-guided Injections|Subjects received octreotide LAR via regular IM gluteal injections every 28 days for 3 months followed by ultrasound-guided IM gluteal injections every 28 days for 3 months.
10897315|NCT00552071|OG000|Outcome|Ultrasound-guided Injections of Octreotide LAR|All subjects receiving ultrasound-guided injections during the study.
10897316|NCT00552071|OG001|Outcome|Regular Injections of Octreotide LAR|All subjects receiving regular injections during the study.
10897317|NCT00552071|OG000|Outcome|Ultrasound-guided Injections of Octreotide LAR|All subjects who recieved ultrasound-guided injections during the study.
10897318|NCT00552071|OG001|Outcome|Regular Injections of Octreotide LAR|All subjects who received regular injections during the study.
10897319|NCT00552071|EG000|Reported Event|Ultrasound-guided Injections Followed by Regular Injections|Subjects received octreotide LAR via ultrasound-guided IM gluteal injections every 28 days for 3 months followed by regular IM gluteal injections every 28 days for 3 months.
10897320|NCT00552071|EG001|Reported Event|Regular Injections Followed by Ultrasound-guided Injections|Subjects received octreotide LAR via regular IM gluteal injections every 28 days for 3 months followed by ultrasound-guided IM gluteal injections every 28 days for 3 months.
10897321|NCT00552084|BG000|Baseline|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
10897322|NCT00552084|BG001|Baseline|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
10897323|NCT00552084|BG002|Baseline|Total|Total of all reporting groups
10897324|NCT00552084|FG000|Participant Flow|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
10897325|NCT00552084|FG001|Participant Flow|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
10897326|NCT00552084|OG000|Outcome|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
10897327|NCT00552084|OG001|Outcome|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
10897328|NCT00552084|EG000|Reported Event|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
10897329|NCT00552084|EG001|Reported Event|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
10897330|NCT00552110|BG000|Baseline|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
10897331|NCT00552110|BG001|Baseline|Combination3|MFNS with OXY 3 sprays once daily
10897332|NCT00552110|BG002|Baseline|Mometasone|MFNS once daily
10897333|NCT00552110|BG003|Baseline|Oxymetazoline|OXY twice daily
10897334|NCT00552110|BG004|Baseline|Placebo|Placebo nasal spray
10897335|NCT00552110|BG005|Baseline|Total|Total of all reporting groups
10897336|NCT00552110|FG000|Participant Flow|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
10897337|NCT00552110|FG001|Participant Flow|Combination3|MFNS with OXY 3 sprays once daily
10897338|NCT00552110|FG002|Participant Flow|Mometasone|MFNS once daily
10897339|NCT00552110|FG003|Participant Flow|Oxymetazoline|OXY twice daily
10897340|NCT00552110|FG004|Participant Flow|Placebo|Placebo nasal spray
10897341|NCT00552110|OG000|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
10897342|NCT00552110|OG001|Outcome|Combination3|MFNS with OXY 3 sprays once daily
10897343|NCT00552110|OG002|Outcome|Mometasone|MFNS once daily
10897344|NCT00552110|OG003|Outcome|Oxymetazoline|OXY twice daily
10897345|NCT00552110|OG004|Outcome|Placebo|Placebo nasal spray
10897346|NCT00552110|EG000|Reported Event|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
10897347|NCT00552110|EG001|Reported Event|Combination3|MFNS with OXY 3 sprays once daily
10897348|NCT00552110|EG002|Reported Event|Mometasone|MFNS once daily
10897349|NCT00552110|EG003|Reported Event|Oxymetazoline|OXY twice daily
10897350|NCT00552110|EG004|Reported Event|Placebo|Placebo nasal spray
10897351|NCT00552175|BG000|Baseline|Placebo|placebo comparator taken orally every day
10897352|NCT00552175|BG001|Baseline|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
10897353|NCT00552175|BG002|Baseline|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
10897354|NCT00552175|BG003|Baseline|Total|Total of all reporting groups
10897355|NCT00552175|FG000|Participant Flow|Placebo|placebo comparator taken orally every day
10897356|NCT00552175|FG001|Participant Flow|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
10897357|NCT00552175|FG002|Participant Flow|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
10897358|NCT00552175|OG000|Outcome|Placebo|placebo comparator taken orally every day
10897359|NCT00552175|OG001|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
10897360|NCT00552175|OG001|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
10897361|NCT00552175|OG002|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
10897362|NCT00552175|EG000|Reported Event|Placebo|placebo comparator taken orally every day
10897363|NCT00552175|EG001|Reported Event|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
10897364|NCT00552175|EG002|Reported Event|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
10897365|NCT00552188|BG000|Baseline|VIA-2291|VIA-2291 100mg
10897366|NCT00552188|BG001|Baseline|Placebo|Matching placebo
10897367|NCT00552188|BG002|Baseline|Total|Total of all reporting groups
10897368|NCT00552188|FG000|Participant Flow|VIA-2291|VIA-2291 100mg
10897369|NCT00552188|FG001|Participant Flow|Placebo|Matching placebo
10897370|NCT00552188|OG000|Outcome|VIA-2291|VIA-2291 100mg
10897371|NCT00552188|OG001|Outcome|Placebo|Matching placebo
10897372|NCT00552188|EG000|Reported Event|VIA-2291|VIA-2291 100mg
10897373|NCT00552188|EG001|Reported Event|Placebo|Matching placebo
10897374|NCT00552240|BG000|Baseline|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
10897375|NCT00552240|BG001|Baseline|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
10897376|NCT00552240|BG002|Baseline|Total|Total of all reporting groups
10897377|NCT00552240|FG000|Participant Flow|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
10897378|NCT00552240|FG001|Participant Flow|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
10897379|NCT00552240|OG000|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
10897380|NCT00552240|OG001|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
10897381|NCT00552240|EG000|Reported Event|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
10897382|NCT00552240|EG001|Reported Event|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
10897383|NCT00552279|BG000|Baseline|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
10897384|NCT00552279|BG001|Baseline|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
10897385|NCT00552279|BG002|Baseline|Total|Total of all reporting groups
10897386|NCT00552279|FG000|Participant Flow|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
10897387|NCT00552279|FG001|Participant Flow|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
10897388|NCT00552279|OG000|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
10897389|NCT00552279|OG001|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
10897390|NCT00552279|EG000|Reported Event|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
10897391|NCT00552279|EG001|Reported Event|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
10897392|NCT00552305|BG000|Baseline|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
10897393|NCT00552305|FG000|Participant Flow|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
10897394|NCT00552305|OG000|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
10897395|NCT00552305|EG000|Reported Event|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
10897396|NCT00552344|BG000|Baseline|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
10897397|NCT00552344|FG000|Participant Flow|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
10897398|NCT00552344|OG000|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
10897399|NCT00552344|OG000|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.~The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
10897400|NCT00552344|EG000|Reported Event|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
10897401|NCT00552396|BG000|Baseline|0.0003 mg/kg|
10897402|NCT00552396|BG001|Baseline|0.003 mg/kg|
10897403|NCT00552396|BG002|Baseline|0.015 mg/kg|
10897404|NCT00552396|BG003|Baseline|0.075 mg/kg|
10897405|NCT00552396|BG004|Baseline|0.3 mg/kg|
10897406|NCT00552396|BG005|Baseline|1 mg/kg|
10897407|NCT00552396|BG006|Baseline|3 mg/kg|
10897408|NCT00552396|BG007|Baseline|Total|Total of all reporting groups
10897409|NCT00552396|FG000|Participant Flow|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
10897410|NCT00552396|FG001|Participant Flow|0.003 mg/kg|
10897411|NCT00552396|FG002|Participant Flow|0.015 mg/kg|
10897412|NCT00552396|FG003|Participant Flow|0.075 mg/kg|
10897413|NCT00552396|FG004|Participant Flow|0.3 mg/kg|
10897414|NCT00552396|FG005|Participant Flow|1 mg/kg|
10897415|NCT00552396|FG006|Participant Flow|3 mg/kg|
10897416|NCT00552396|OG000|Outcome|IPH2101 0.0003 mg/kg|Participants were administered an IV dose of 0.0003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
10897417|NCT00552396|OG001|Outcome|IPH2101 0.003 mg/kg|Participants were administered an IV dose of 0.003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
10897418|NCT00552396|OG002|Outcome|IPH2101 0.015 mg/kg|Participants were administered an IV dose of 0.015 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
10897419|NCT00552396|OG003|Outcome|IPH2101 0.075 mg/kg|Participants were administered an IV dose of 0.075 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
10897420|NCT00552396|OG004|Outcome|IPH2101 0.3mg/kg|Participants were administered an IV dose of 0.3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
10914804|NCT00632814|BG001|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
10897421|NCT00552396|OG005|Outcome|IPH2101 1mg/kg|Participants were administered an IV dose of 1 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
10897422|NCT00552396|OG006|Outcome|IPH2101 3 mg/kg|Participants were administered an IV dose of 3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level.If MTD this is not reached at 3mg/kg, 7 subjects will be enrolled at this dose to obtain more data from a larger subject pool to better evaluate safety, PK, PD and signs of efficacy.
10897423|NCT00552396|OG000|Outcome|IPH2101 0.0003 mg/kg|IV Bolus
10897424|NCT00552396|OG001|Outcome|IPH2101 0.003 mg/kg|IV Bolus
10897425|NCT00552396|OG002|Outcome|IPH2101 0.015 mg/kg|IV Bolus
10897426|NCT00552396|OG003|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
10897427|NCT00552396|OG004|Outcome|IPH2101 0.3 mg/kg|IV 1 hour infusion
10897428|NCT00552396|OG005|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
10897429|NCT00552396|OG006|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
10897430|NCT00552396|OG000|Outcome|IPH2101 0.0003 mg/kg|IV bolus injection
10897431|NCT00552396|OG001|Outcome|IPH2101 0.003 mg/kg|IV bolus injection
10897432|NCT00552396|OG002|Outcome|IPH2101 0.015 mg/kg|IV bolus injection
10897433|NCT00552396|OG004|Outcome|IPH2101 0.3mg/kg|IV 1 hour infusion
10897434|NCT00552396|OG000|Outcome|IPH2101 0.0003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
10897435|NCT00552396|OG001|Outcome|IPH2101 0.003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
10897436|NCT00552396|OG002|Outcome|IPH2101 0.015 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
10897437|NCT00552396|OG003|Outcome|IPH2101 0.075 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
10897438|NCT00552396|OG004|Outcome|IPH2101 0.3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
10897439|NCT00552396|OG005|Outcome|IPH2101 1 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
10897440|NCT00552396|OG006|Outcome|IPH2101 3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
10897441|NCT00552396|EG000|Reported Event|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
10897442|NCT00552396|EG001|Reported Event|0.003 mg/kg|
10897443|NCT00552396|EG002|Reported Event|0.015 mg/kg|
10897444|NCT00552396|EG003|Reported Event|0.075 mg/kg|
10897445|NCT00552396|EG004|Reported Event|0.3 mg/kg|
10897446|NCT00552396|EG005|Reported Event|1 mg/kg|
10897447|NCT00552396|EG006|Reported Event|3 mg/kg|
10897448|NCT00552409|BG000|Baseline|Cholecalciferol|2000 IU by mouth daily for one year
10897449|NCT00552409|BG001|Baseline|Placebo|One softgel daily for one year
10897450|NCT00552409|BG002|Baseline|Total|Total of all reporting groups
10897451|NCT00552409|FG000|Participant Flow|Cholecalciferol|2000 IU by mouth daily for one year
10897452|NCT00552409|FG001|Participant Flow|Placebo|One softgel daily for one year
10897453|NCT00552409|OG000|Outcome|Cholecalciferol|2000 IU by mouth daily for one year
10897454|NCT00552409|OG001|Outcome|Placebo|One softgel daily for one year
10897455|NCT00552409|EG000|Reported Event|Cholecalciferol|2000 IU by mouth daily for one year
10897456|NCT00552409|EG001|Reported Event|Placebo|One softgel daily for one year
10897457|NCT00552422|BG000|Baseline|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
10897458|NCT00552422|FG000|Participant Flow|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
10897459|NCT00552422|OG000|Outcome|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
10897460|NCT00552422|EG000|Reported Event|Domperidone|Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.
10897461|NCT00552448|BG000|Baseline|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
10897462|NCT00552448|BG001|Baseline|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
10897463|NCT00552448|BG002|Baseline|Total|Total of all reporting groups
10897464|NCT00552448|FG000|Participant Flow|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
10897465|NCT00552448|FG001|Participant Flow|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
10897466|NCT00552448|OG000|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
10897467|NCT00552448|OG001|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
10897468|NCT00552448|EG000|Reported Event|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
10897469|NCT00552448|EG001|Reported Event|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
10897470|NCT00552578|BG000|Baseline|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
10897471|NCT00552578|BG001|Baseline|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
10897472|NCT00552578|BG002|Baseline|Total|Total of all reporting groups
10897473|NCT00552578|FG000|Participant Flow|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
10897474|NCT00552578|FG001|Participant Flow|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
10897475|NCT00552578|OG000|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
10897476|NCT00552578|OG001|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
10897477|NCT00552578|EG000|Reported Event|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
10897478|NCT00552578|EG001|Reported Event|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
10897479|NCT00552617|BG000|Baseline|Rocuronium + Placebo|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10897480|NCT00552617|BG001|Baseline|Rocuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10897481|NCT00552617|BG002|Baseline|Rocuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10897482|NCT00552617|BG003|Baseline|Rocuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10897483|NCT00552617|BG004|Baseline|Rocuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10897484|NCT00552617|BG005|Baseline|Vecuronium + Placebo|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10897485|NCT00552617|BG006|Baseline|Vecuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10897486|NCT00552617|BG007|Baseline|Vecuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10897487|NCT00552617|BG008|Baseline|Vecuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10897488|NCT00552617|BG009|Baseline|Vecuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10897489|NCT00552617|BG010|Baseline|Total|Total of all reporting groups
11090580|NCT01529645|OG005|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
10897490|NCT00552617|FG000|Participant Flow|Rocuronium + Placebo|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10897491|NCT00552617|FG001|Participant Flow|Rocuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10897492|NCT00552617|FG002|Participant Flow|Rocuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10897493|NCT00552617|FG003|Participant Flow|Rocuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10897494|NCT00552617|FG004|Participant Flow|Rocuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10897495|NCT00552617|FG005|Participant Flow|Vecuronium + Placebo|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10897496|NCT00552617|FG006|Participant Flow|Vecuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10897497|NCT00552617|FG007|Participant Flow|Vecuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10897498|NCT00552617|FG008|Participant Flow|Vecuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10897499|NCT00552617|FG009|Participant Flow|Vecuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10897500|NCT00552617|OG000|Outcome|Rocuronium + Placebo|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10897501|NCT00552617|OG001|Outcome|Rocuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10897502|NCT00552617|OG002|Outcome|Rocuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10897503|NCT00552617|OG003|Outcome|Rocuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10897504|NCT00552617|OG004|Outcome|Rocuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10897505|NCT00552617|OG005|Outcome|Vecuronium + Placebo|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
11171700|NCT02005016|OG000|Outcome|Behavioral Therapy|"All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.~Naming therapy: Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day)."
10897506|NCT00552617|OG006|Outcome|Vecuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10897507|NCT00552617|OG007|Outcome|Vecuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10897508|NCT00552617|OG008|Outcome|Vecuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10897509|NCT00552617|OG009|Outcome|Vecuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10897510|NCT00552617|EG000|Reported Event|Rocuronium + Placebo|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10897511|NCT00552617|EG001|Reported Event|Rocuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10897512|NCT00552617|EG002|Reported Event|Rocuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10897513|NCT00552617|EG003|Reported Event|Rocuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10897514|NCT00552617|EG004|Reported Event|Rocuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10897515|NCT00552617|EG005|Reported Event|Vecuronium + Placebo|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10897516|NCT00552617|EG006|Reported Event|Vecuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10897517|NCT00552617|EG007|Reported Event|Vecuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10897518|NCT00552617|EG008|Reported Event|Vecuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10897519|NCT00552617|EG009|Reported Event|Vecuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10897520|NCT00552669|BG000|Baseline|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
10897521|NCT00552669|BG001|Baseline|Drug Eluting Stents|Any Drug Eluting Stents
10897522|NCT00552669|BG002|Baseline|Total|Total of all reporting groups
10897523|NCT00552669|FG000|Participant Flow|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
11171701|NCT02005016|EG000|Reported Event|Behavioral Therapy|"All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.~Naming therapy: Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day)."
10897524|NCT00552669|FG001|Participant Flow|Drug Eluting Stents|Any Drug Eluting Stents
10897525|NCT00552669|OG000|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
11171702|NCT02005029|BG000|Baseline|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
11171703|NCT02005029|BG001|Baseline|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
10897526|NCT00552669|OG001|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
10897527|NCT00552669|EG000|Reported Event|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
10897528|NCT00552669|EG001|Reported Event|Drug Eluting Stents|Any Drug Eluting Stents
10897529|NCT00552695|BG000|Baseline|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
10897530|NCT00552695|BG001|Baseline|Control Patch|Warm patch with no active substances
10897531|NCT00552695|BG002|Baseline|Total|Total of all reporting groups
10897532|NCT00552695|FG000|Participant Flow|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
10897533|NCT00552695|FG001|Participant Flow|Control Patch|Warm patch with no active substances
10897534|NCT00552695|OG000|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
10897535|NCT00552695|OG001|Outcome|Control Patch|Warm patch with no active substances
10897536|NCT00552695|EG000|Reported Event|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
10897537|NCT00552695|EG001|Reported Event|Control Patch|Warm patch with no active substances
10897538|NCT00552760|BG000|Baseline|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
10897539|NCT00552760|BG001|Baseline|Placebo|one tablet at bedtime for up to 6 months
10897540|NCT00552760|BG002|Baseline|Total|Total of all reporting groups
10897541|NCT00552760|FG000|Participant Flow|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
10897542|NCT00552760|FG001|Participant Flow|Placebo|one tablet at bedtime for up to 6 months
10897543|NCT00552760|OG000|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
10897544|NCT00552760|OG001|Outcome|Placebo|one tablet at bedtime for up to 6 months
10897545|NCT00552760|EG000|Reported Event|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
10897546|NCT00552760|EG001|Reported Event|Placebo|one tablet at bedtime for up to 6 months
10897547|NCT00552786|BG000|Baseline|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
10897548|NCT00552786|BG001|Baseline|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
10897549|NCT00552786|BG002|Baseline|Total|Total of all reporting groups
10897550|NCT00552786|FG000|Participant Flow|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
10897551|NCT00552786|FG001|Participant Flow|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
10897552|NCT00552786|OG000|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
10897553|NCT00552786|OG001|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
11090581|NCT01529645|OG006|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090582|NCT01529645|OG007|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090583|NCT01529645|OG008|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090584|NCT01529645|OG009|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
11090585|NCT01529645|OG003|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
11090586|NCT01529645|OG000|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090587|NCT01529645|OG001|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090588|NCT01529645|OG002|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11171704|NCT02005029|BG002|Baseline|Total|Total of all reporting groups
10897554|NCT00552786|EG000|Reported Event|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
10897555|NCT00552786|EG001|Reported Event|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
10897556|NCT00552812|BG000|Baseline|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
10897557|NCT00552812|FG000|Participant Flow|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
10897558|NCT00552812|OG000|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
10897559|NCT00552812|EG000|Reported Event|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
11090589|NCT01529645|OG000|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090590|NCT01529645|OG001|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090591|NCT01529645|OG002|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090592|NCT01529645|OG003|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
11090593|NCT01529645|EG000|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
11090594|NCT01529645|EG001|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
11090595|NCT01529645|EG002|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
11090596|NCT01529645|EG003|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090597|NCT01529645|EG004|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090598|NCT01529645|EG005|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090599|NCT01529645|EG006|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090600|NCT01529645|EG007|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090601|NCT01529645|EG008|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
11090602|NCT01529645|EG009|Reported Event|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
10897560|NCT00552929|BG000|Baseline|Sugammadex 0.5 mg/kg (Rocuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
11090603|NCT01529749|BG000|Baseline|EFV/FTC/TDF|EFV/FTC/TDF: 600/200/245 mg, od, oral
11090604|NCT01529749|BG001|Baseline|EFV/FTC/TDF + Losartan|EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
10897561|NCT00552929|BG001|Baseline|Sugammadex 1.0 mg/kg (Rocuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897562|NCT00552929|BG002|Baseline|Sugammadex 2.0 mg/kg (Rocuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897563|NCT00552929|BG003|Baseline|Sugammadex 4.0 mg/kg (Rocuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897564|NCT00552929|BG004|Baseline|Sugammadex 8.0 mg/kg (Rocuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897565|NCT00552929|BG005|Baseline|Sugammadex 0.5 mg/kg (Vecuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
10897566|NCT00552929|BG006|Baseline|Sugammadex 1.0 mg/kg (Vecuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897567|NCT00552929|BG007|Baseline|Sugammadex 2.0 mg/kg (Vecuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897568|NCT00552929|BG008|Baseline|Sugammadex 4.0 mg/kg (Vecuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897569|NCT00552929|BG009|Baseline|Sugammadex 8.0 mg/kg (Vecuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897570|NCT00552929|BG010|Baseline|Total|Total of all reporting groups
10897571|NCT00552929|FG000|Participant Flow|Sugammadex 0.5 mg/kg (Rocuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897572|NCT00552929|FG001|Participant Flow|Sugammadex 1.0 mg/kg (Rocuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897573|NCT00552929|FG002|Participant Flow|Sugammadex 2.0 mg/kg (Rocuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897574|NCT00552929|FG003|Participant Flow|Sugammadex 4.0 mg/kg (Rocuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
11090605|NCT01529749|BG002|Baseline|FTC/TDF + MK-0518|FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
11090606|NCT01529749|BG003|Baseline|FTC/TDF+MK-0518+Losartan|FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
11090607|NCT01529749|BG004|Baseline|Total|Total of all reporting groups
11090608|NCT01529749|FG000|Participant Flow|EFV/FTC/TDF|EFV/FTC/TDF: 600/200/245 mg, od, oral
11090609|NCT01529749|FG001|Participant Flow|EFV/FTC/TDF + Losartan|EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
11090610|NCT01529749|FG002|Participant Flow|FTC/TDF + MK-0518|FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
11090611|NCT01529749|FG003|Participant Flow|FTC/TDF+MK-0518+Losartan|FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
11090612|NCT01529749|OG000|Outcome|EFV/FTC/TDF|EFV/FTC/TDF: 600/200/245 mg, od, oral
11090613|NCT01529749|OG001|Outcome|EFV/FTC/TDF + Losartan|EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
11090614|NCT01529749|OG002|Outcome|FTC/TDF + MK-0518|FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
11090615|NCT01529749|OG003|Outcome|FTC/TDF+MK-0518+Losartan|FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
11090616|NCT01529749|EG000|Reported Event|EFV/FTC/TDF|EFV/FTC/TDF: 600/200/245 mg, od, oral
11171705|NCT02005029|FG000|Participant Flow|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
10897575|NCT00552929|FG004|Participant Flow|Sugammadex 8.0 mg/kg (Rocuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897576|NCT00552929|FG005|Participant Flow|Sugammadex 0.5 mg/kg (Vecuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
10897577|NCT00552929|FG006|Participant Flow|Sugammadex 1.0 mg/kg (Vecuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897578|NCT00552929|FG007|Participant Flow|Sugammadex 2.0 mg/kg (Vecuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897579|NCT00552929|FG008|Participant Flow|Sugammadex 4.0 mg/kg (Vecuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897580|NCT00552929|FG009|Participant Flow|Sugammadex 8.0 mg/kg (Vecuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897581|NCT00552929|OG000|Outcome|Sugammadex 0.5 mg/kg (Rocuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897582|NCT00552929|OG001|Outcome|Sugammadex 1.0 mg/kg (Rocuroniium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897583|NCT00552929|OG002|Outcome|Sugammadex 2.0 mg/kg (Rocuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897584|NCT00552929|OG003|Outcome|Sugammadex 4.0 mg/kg (Rocuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897585|NCT00552929|OG004|Outcome|Sugammadex 8.0 mg/kg (Rocuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897586|NCT00552929|OG005|Outcome|Sugammadex 0.5 mg/kg (Vecuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
10897587|NCT00552929|OG006|Outcome|Sugammadex 1.0 mg/kg (Vecuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897588|NCT00552929|OG007|Outcome|Sugammadex 2.0 mg/kg (Vecuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897589|NCT00552929|OG008|Outcome|Sugammadex 4.0 mg/kg (Vecuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897590|NCT00552929|OG009|Outcome|Sugammadex 8.0 mg/kg (Vecuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897591|NCT00552929|EG000|Reported Event|Sugammadex 0.5 mg/kg (Rocuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 posttetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897592|NCT00552929|EG001|Reported Event|Sugammadex 1.0 mg/kg (Rocuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897593|NCT00552929|EG002|Reported Event|Sugammadex 2.0 mg/kg (Rocuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897594|NCT00552929|EG003|Reported Event|Sugammadex 4.0 mg/kg (Rocuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897595|NCT00552929|EG004|Reported Event|Sugammadex 8.0 mg/kg (Rocuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10897596|NCT00552929|EG005|Reported Event|Sugammadex 0.5 mg/kg (Vecuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary.
10897597|NCT00552929|EG006|Reported Event|Sugammadex 1.0 mg/kg (Vecuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897598|NCT00552929|EG007|Reported Event|Sugammadex 2.0 mg/kg (Vecuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897599|NCT00552929|EG008|Reported Event|Sugammadex 4.0 mg/kg (Vecuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
11171706|NCT02005029|FG001|Participant Flow|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
10897600|NCT00552929|EG009|Reported Event|Sugammadex 8.0 mg/kg (Vecuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
10897601|NCT00553059|BG000|Baseline|Dronabinol|Dronabinol 1 capsule three times per day for 5 days
10897602|NCT00553059|BG001|Baseline|Placebo|Placebo 1 capsule three times per day for 5 days
10897603|NCT00553059|BG002|Baseline|Total|Total of all reporting groups
10897604|NCT00553059|FG000|Participant Flow|Dronabinol|Dronabinol 1 capsule three times per day for 5 days
10897605|NCT00553059|FG001|Participant Flow|Placebo|Placebo 1 capsule three times per day for 5 days
10897606|NCT00553059|OG000|Outcome|Dronabinol|Dronabinol 1 capsule three times per day for 5 days
10897607|NCT00553059|OG001|Outcome|Placebo|Placebo 1 capsule three times per day for 5 days
10897608|NCT00553059|EG000|Reported Event|Dronabinol|Dronabinol 1 capsule three times per day for 5 days
10897609|NCT00553059|EG001|Reported Event|Placebo|Placebo 1 capsule three times per day for 5 days
10897610|NCT00553098|BG000|Baseline|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
10897611|NCT00553098|FG000|Participant Flow|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
10897612|NCT00553098|OG000|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
10897613|NCT00553098|OG000|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
10897614|NCT00553098|OG000|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic S"
10897615|NCT00553098|OG000|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic"
10897616|NCT00553098|OG000|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic Ste"
10897617|NCT00553098|EG000|Reported Event|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV~Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
10897618|NCT00553150|BG000|Baseline|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897619|NCT00553150|BG001|Baseline|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897620|NCT00553150|BG002|Baseline|Total|Total of all reporting groups
10897621|NCT00553150|FG000|Participant Flow|Phase I: Cohort/Dose Level 1 (30 mg RAD001)|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897622|NCT00553150|FG001|Participant Flow|Phase I: Cohort/Dose Level 2 (50 mg RAD001)|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897623|NCT00553150|FG002|Participant Flow|Phase 1: Cohort/Dose Level 3 (70 mg RAD001)|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897624|NCT00553150|FG003|Participant Flow|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897625|NCT00553150|OG000|Outcome|Phase I: Dose Level 0|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10914805|NCT00632814|BG002|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
10914806|NCT00632814|BG003|Baseline|Total|Total of all reporting groups
11090617|NCT01529749|EG001|Reported Event|EFV/FTC/TDF + Losartan|EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
11090618|NCT01529749|EG002|Reported Event|FTC/TDF + MK-0518|FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
10897626|NCT00553150|OG001|Outcome|Phase I: Dose Level 1|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897627|NCT00553150|OG002|Outcome|Phase I: Dose Level 2|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897628|NCT00553150|OG000|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897629|NCT00553150|EG000|Reported Event|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
11090619|NCT01529749|EG003|Reported Event|FTC/TDF+MK-0518+Losartan|FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
11090620|NCT01529827|BG000|Baseline|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
11090621|NCT01529827|FG000|Participant Flow|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
11090622|NCT01529827|OG000|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
10897630|NCT00553150|EG001|Reported Event|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
10897631|NCT00553163|BG000|Baseline|Gut-focussed Hypnotherapy|16 Patients with inactive ulcerative colitis given gut-focussed hypnotherapy
10897632|NCT00553163|BG001|Baseline|Controlled Educational Sessions|10 Patients with inactive ulcerative colitis given educational sessions
10897633|NCT00553163|BG002|Baseline|Total|Total of all reporting groups
10897634|NCT00553163|FG000|Participant Flow|Gut-focussed Hypnotherapy (GFH)|Patients given gut-focussed hypnotherapy (GFH).after withdrawing from thiopurine
10897635|NCT00553163|FG001|Participant Flow|Control Educational Sessions|Patients given control educational sessions after withdrawing from thiopurines
10897636|NCT00553163|OG000|Outcome|UC Patients Given Gut-focussed Hypnotherapy|Gut-focussed hypnotherapy (GFH). Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13).
11171707|NCT02005029|OG000|Outcome|Erythromycin|Mean gastric emptying time for participants receiving erythromycin
11171708|NCT02005029|OG001|Outcome|Placebo|Mean gastric emptying time for participants receiving placebo
11171709|NCT02005029|OG000|Outcome|Erythromycin|Area under the curve 0-4 hours for plasma levodopa after erythromycin
10897637|NCT00553163|OG001|Outcome|UC Patients Given Control Educational Sessions|Controlled educational sessions:Subjects were seen at 4-weekly intervals (a total of 4 face-to-face visits in the 13 week treatment, at weeks 1, 5, 9 and 13),
10897638|NCT00553163|OG000|Outcome|UC Patients Given Gut-focussed Hypnotherapy|Gut-focussed hypnotherapy (GFH).Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13).
10897639|NCT00553163|OG000|Outcome|UC Patients Given Gut-focussed Hpynotherapy|Gut-focussed hypnotherapy (GFH).Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13).
10897640|NCT00553163|OG000|Outcome|UC Patients Given Gut-focussed Hypnotherapy|Gut-focussed hypnotherapy (GFH). Session one was spent familiarising the patient with the process. Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13). After the end of the initial 13 week period, patients were asked to continue to practise self-hypnosis, and were phoned monthly by the therapist
10897641|NCT00553163|OG001|Outcome|UC Patients Given Control Educational Sessions|Controlled educational sessions: Subjects were seen at 4-weekly intervals (a total of 4 face-to-face visits in the 13 week treatment, at weeks 1, 5, 9 and 13), and received a phone call at weekly intervals from the therapist to monitor progress and field questions. After the end of the initial 13 week period, patients were phoned monthly by the therapist. No attempt was made to offer any form of relaxation techniques to these patients.
10897642|NCT00553163|OG000|Outcome|UC Patients Given Gut-focussed Hypnotherapy|Gut-focussed hypnotherapy (GFH). Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13
10897643|NCT00553163|EG000|Reported Event|Gut-focussed Hypnotherapy (GFH)|"Patients given gut-focussed hypnotherapy (GFH).after withdrawing from thiopurine.~No adverse events apart from relapse"
10897644|NCT00553163|EG001|Reported Event|Controlled Educational Sessions|Patients given controlled educational sessions after withdrawing from thiopurines No adverse events apart from relapse
10897645|NCT00553202|BG000|Baseline|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
10897646|NCT00553202|FG000|Participant Flow|Treatment (Chemotherapy and Allogeneic SCT)|All patients
10897647|NCT00553202|OG000|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
10897648|NCT00553202|OG000|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
10897649|NCT00553202|EG000|Reported Event|Group 1|All patients
10897650|NCT00553254|BG000|Baseline|PF-00299804 - Phase 1 All Participants|A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897651|NCT00553254|BG001|Baseline|PF-00299804 45 mg - Phase 2|PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897652|NCT00553254|BG002|Baseline|Total|Total of all reporting groups
10897653|NCT00553254|FG000|Participant Flow|PF-00299804 30 mg - Phase 1|A single dose of PF-00299804 30 milligram (mg) tablet orally on or before Day -9 followed by PF-00299804 30 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
11171710|NCT02005029|OG001|Outcome|Placebo|Area under the curve 0-4 hours for plasma levodopa after placebo
10897654|NCT00553254|FG001|Participant Flow|PF-00299804 45 mg - Phase 1|A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897655|NCT00553254|FG002|Participant Flow|PF-00299804 45 mg - Phase 2|PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897656|NCT00553254|OG000|Outcome|PF-00299804 - Phase 1 All Participants|A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897657|NCT00553254|OG000|Outcome|PF-00299804 45 mg - Phase 2|PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897658|NCT00553254|OG000|Outcome|PF-00299804 30 mg - Phase 1|A single dose of PF-00299804 30 milligram (mg) tablet orally on or before Day -9 followed by PF-00299804 30 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897659|NCT00553254|OG001|Outcome|PF-00299804 45 mg - Phase 1|A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897660|NCT00553254|OG001|Outcome|PF-00299804 45 mg - Phase 2|PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897661|NCT00553254|OG001|Outcome|PF-00299804 45 mg|A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 during Phase 1 or PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles during Phase 2, until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897662|NCT00553254|OG002|Outcome|PF-00299804 45 mg - Phase 2|PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897663|NCT00553254|EG000|Reported Event|PF-00299804 30 mg - Phase 1|A single dose of PF-00299804 30 milligram (mg) tablet orally on or before Day -9 followed by PF-00299804 30 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
11171711|NCT02005029|OG000|Outcome|Erythromycin|Mean time for right hand after erythromycin
11171712|NCT02005029|OG001|Outcome|Placebo|Mean time for right hand after placebo
11171713|NCT02005029|OG000|Outcome|Erythromycin|Five times sit-to-stand for all participants receiving erythromycin
10897664|NCT00553254|EG001|Reported Event|PF-00299804 45 mg - Phase 1|A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897665|NCT00553254|EG002|Reported Event|PF-00299804 45 mg - Phase 2|PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
10897666|NCT00553267|BG000|Baseline|Amlodipine 10mg|
10897667|NCT00553267|BG001|Baseline|Telmisartan 40mg and Amlodipine 10mg|
10897668|NCT00553267|BG002|Baseline|Telmisartan 80mg and Amlodipine 10mg|
10897669|NCT00553267|BG003|Baseline|Total|Total of all reporting groups
10897670|NCT00553267|FG000|Participant Flow|Amlodipine 10mg|
10897671|NCT00553267|FG001|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|
10897672|NCT00553267|FG002|Participant Flow|Telmisartan 80mg and Amlodipine 10mg|
10897673|NCT00553267|OG000|Outcome|Amlodipine 10mg|
10897674|NCT00553267|OG001|Outcome|Telmisartan 40mg and Amlodipine 10mg|
10897675|NCT00553267|OG002|Outcome|Telmisartan 80mg and Amlodipine 10mg|
10897676|NCT00553267|EG000|Reported Event|Amlodipine 10mg|
10897677|NCT00553267|EG001|Reported Event|Telmisartan 40mg and Amlodipine 10mg|
11171714|NCT02005029|OG001|Outcome|Placebo|Five times sit-to-stand for all participants receiving placebo
11171715|NCT02005029|OG000|Outcome|Erythromycin|Mean CGS for all participants receiving erythromycin
10897678|NCT00553267|EG002|Reported Event|Telmisartan 80mg and Amlodipine 10mg|
10897679|NCT00553280|BG000|Baseline|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
10897680|NCT00553280|FG000|Participant Flow|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
10897681|NCT00553280|OG000|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
10897682|NCT00553280|EG000|Reported Event|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
10897683|NCT00553319|BG000|Baseline|Placebo|"Placebo~Placebo: Placebo group"
10897684|NCT00553319|BG001|Baseline|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
10897685|NCT00553319|BG002|Baseline|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
10897686|NCT00553319|BG003|Baseline|Total|Total of all reporting groups
10897687|NCT00553319|FG000|Participant Flow|Placebo|"Placebo~Placebo: Placebo group"
10897688|NCT00553319|FG001|Participant Flow|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
10897689|NCT00553319|FG002|Participant Flow|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
10897690|NCT00553319|OG000|Outcome|Placebo|"Placebo~Placebo: Placebo group"
10897691|NCT00553319|OG001|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
10897692|NCT00553319|OG002|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
10897693|NCT00553319|EG000|Reported Event|Placebo|"Placebo~Placebo: Placebo group"
10897694|NCT00553319|EG001|Reported Event|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
10897695|NCT00553319|EG002|Reported Event|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
10897696|NCT00553332|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
10897697|NCT00553332|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
10897698|NCT00553332|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
11171716|NCT02005029|OG001|Outcome|Placebo|Mean CGS for all participants receiving placebo
11171717|NCT02005029|OG000|Outcome|Erythromycin|TUAG (comfortable speed) after erythromycin
11171718|NCT02005029|OG001|Outcome|Placebo|TUAG (comfortable speed) after placebo
10897699|NCT00553332|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
10897700|NCT00553358|BG000|Baseline|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
10897701|NCT00553358|BG001|Baseline|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
11171719|NCT02005029|OG000|Outcome|Erythromycin|TUAG (fast speed) after erythromycin
10897702|NCT00553358|BG002|Baseline|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897703|NCT00553358|BG003|Baseline|Total|Total of all reporting groups
10897704|NCT00553358|FG000|Participant Flow|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897705|NCT00553358|FG001|Participant Flow|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
10897706|NCT00553358|FG002|Participant Flow|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897707|NCT00553358|OG000|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
10897708|NCT00553358|OG001|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897709|NCT00553358|OG002|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897710|NCT00553358|OG000|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897711|NCT00553358|OG001|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
10897712|NCT00553358|OG002|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897713|NCT00553358|OG000|Outcome|Pathological Complete Response (pCR)|locoregional pathological Complete Response (pCR)
10897714|NCT00553358|OG001|Outcome|No Pathological Complete Response (pCR)|no locoregional pathological Complete Response (pCR)
10897715|NCT00553358|OG002|Outcome|Overall|Overall - of the 3 arms
10897716|NCT00553358|EG000|Reported Event|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897717|NCT00553358|EG001|Reported Event|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
10897718|NCT00553358|EG002|Reported Event|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
10897719|NCT00553410|BG000|Baseline|Arm A: Continuous Letrozole|"Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)~Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously"
10897720|NCT00553410|BG001|Baseline|Arm B: Intermittent Letrozole|"Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months~Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months"
10897721|NCT00553410|BG002|Baseline|Total|Total of all reporting groups
10897722|NCT00553410|FG000|Participant Flow|Arm A: Continuous Letrozole|"Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)~Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously"
10897723|NCT00553410|FG001|Participant Flow|Arm B: Intermittent Letrozole|"Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months~Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months"
10897724|NCT00553410|OG000|Outcome|Arm A: Continuous Letrozole|"Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)~Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously"
10897725|NCT00553410|OG001|Outcome|Arm B: Intermittent Letrozole|"Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months~Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months"
10897726|NCT00553410|EG000|Reported Event|Arm A: Continuous Letrozole|"Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)~Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously"
10897727|NCT00553410|EG001|Reported Event|Arm B: Intermittent Letrozole|"Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months~Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months"
10897728|NCT00553436|BG000|Baseline|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
10897729|NCT00553436|FG000|Participant Flow|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
10897730|NCT00553436|OG000|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
10897731|NCT00553436|EG000|Reported Event|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
10897732|NCT00553462|BG000|Baseline|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
10897733|NCT00553462|FG000|Participant Flow|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
10897734|NCT00553462|OG000|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
10897735|NCT00553462|EG000|Reported Event|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
10897736|NCT00553475|BG000|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
10897737|NCT00553475|BG001|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
10897738|NCT00553475|BG002|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
10897739|NCT00553475|BG003|Baseline|Total|Total of all reporting groups
10897740|NCT00553475|FG000|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
10897741|NCT00553475|FG001|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
10897742|NCT00553475|FG002|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
10897743|NCT00553475|OG000|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
10897744|NCT00553475|OG001|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
10897745|NCT00553475|OG002|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
10897746|NCT00553475|OG001|Outcome|Expected Exposure Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with normal CLcr in the pregabalin 300 mg/day group received pregabalin 300 mg/day for 12 weeks.
10897747|NCT00553475|OG002|Outcome|Expected Exposure Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr in the pregabalin 300 and 600 mg/day groups received pregabalin 300 mg/day and subjects with normal CLcr in the pregabalin 600 mg/day group received pregabalin 600 mg/day for 12 weeks.
10897748|NCT00553475|EG000|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
10897749|NCT00553475|EG001|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
10897750|NCT00553475|EG002|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
10897751|NCT00553501|BG000|Baseline|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
10897752|NCT00553501|FG000|Participant Flow|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
10897753|NCT00553501|OG000|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
10897754|NCT00553501|EG000|Reported Event|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
10897755|NCT00553514|BG000|Baseline|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897756|NCT00553514|BG001|Baseline|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897757|NCT00553514|BG002|Baseline|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897758|NCT00553514|BG003|Baseline|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897759|NCT00553514|BG004|Baseline|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897760|NCT00553514|BG005|Baseline|Total|Total of all reporting groups
10897761|NCT00553514|FG000|Participant Flow|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897762|NCT00553514|FG001|Participant Flow|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897763|NCT00553514|FG002|Participant Flow|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897764|NCT00553514|FG003|Participant Flow|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897765|NCT00553514|FG004|Participant Flow|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897766|NCT00553514|OG000|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
11171720|NCT02005029|OG001|Outcome|Placebo|TUAG (fast speed) after placebo
11171721|NCT02005029|OG000|Outcome|Erythromycin|AIMS after receiving erythromycin
11171722|NCT02005029|OG001|Outcome|Placebo|AIMS after receiving placebo
11171723|NCT02005029|OG000|Outcome|Erythromycin|
11171724|NCT02005029|OG001|Outcome|Placebo|
11171725|NCT02005029|OG000|Outcome|Erythromycin|Cmax of plasma levodopa after erythromycin
11171726|NCT02005029|OG001|Outcome|Placebo|Cmax of plasma levodopa after placebo
11171727|NCT02005029|EG000|Reported Event|Erythromycin|Participants who received a one time dose of IV erythromycin
10897767|NCT00553514|OG001|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897768|NCT00553514|OG002|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897769|NCT00553514|OG003|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897770|NCT00553514|OG004|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897771|NCT00553514|EG000|Reported Event|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897772|NCT00553514|EG001|Reported Event|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897773|NCT00553514|EG002|Reported Event|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897774|NCT00553514|EG003|Reported Event|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897775|NCT00553514|EG004|Reported Event|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
10897776|NCT00553540|BG000|Baseline|Control Group|Patients in this group will receive physical therapy and posture education for low back pain
10897777|NCT00553540|BG001|Baseline|Test Group|"Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain~Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs."
10897778|NCT00553540|BG002|Baseline|Total|Total of all reporting groups
10897779|NCT00553540|FG000|Participant Flow|Control Group|Patients in this group will receive physical therapy and posture education for low back pain
11171728|NCT02005029|EG001|Reported Event|Placebo|Participants who received a one time dose of placebo
11171729|NCT02005211|BG000|Baseline|Placebo Part 1|Placebo Part 1 - SAD
11171730|NCT02005211|BG001|Baseline|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
11171731|NCT02005211|BG002|Baseline|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
11171732|NCT02005211|BG003|Baseline|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
11171733|NCT02005211|BG004|Baseline|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
11171734|NCT02005211|BG005|Baseline|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
11171735|NCT02005211|BG006|Baseline|Placebo Part 2|Placebo Part 2 - MAD
10897780|NCT00553540|FG001|Participant Flow|Test Group|"Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain~Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs."
10897781|NCT00553540|OG000|Outcome|Control Group|Patients in this group will receive physical therapy and posture education for low back pain
10897782|NCT00553540|OG001|Outcome|Test Group|"Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain~Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs."
10897783|NCT00553540|EG000|Reported Event|Control Group|Patients in this group will receive physical therapy and posture education for low back pain
10897784|NCT00553540|EG001|Reported Event|Test Group|"Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain~Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs."
10897785|NCT00553605|BG000|Baseline|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
10897786|NCT00553605|BG001|Baseline|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
10897787|NCT00553605|BG002|Baseline|Total|Total of all reporting groups
10897788|NCT00553605|FG000|Participant Flow|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
10897789|NCT00553605|FG001|Participant Flow|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
10897790|NCT00553605|OG000|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
10897791|NCT00553605|OG001|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
10897792|NCT00553605|EG000|Reported Event|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
10897793|NCT00553605|EG001|Reported Event|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
10897794|NCT00553631|BG000|Baseline|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
10897795|NCT00553631|BG001|Baseline|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
10897796|NCT00553631|BG002|Baseline|Total|Total of all reporting groups
10897797|NCT00553631|FG000|Participant Flow|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 unit per kilogram (U/kg) administered intravenously (IV) every other week for 39 weeks.
10897798|NCT00553631|FG001|Participant Flow|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
10897799|NCT00553631|OG000|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
10897800|NCT00553631|OG001|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
10897801|NCT00553631|EG000|Reported Event|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
10897802|NCT00553631|EG001|Reported Event|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
10897803|NCT00553644|BG000|Baseline|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
10897804|NCT00553644|FG000|Participant Flow|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
10897805|NCT00553644|OG000|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
10897806|NCT00553644|EG000|Reported Event|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|lenalidomide: Given PO
10897807|NCT00553696|BG000|Baseline|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897808|NCT00553696|BG001|Baseline|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
10897809|NCT00553696|BG002|Baseline|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897810|NCT00553696|BG003|Baseline|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
10897811|NCT00553696|BG004|Baseline|Total|Total of all reporting groups
10897812|NCT00553696|FG000|Participant Flow|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897813|NCT00553696|FG001|Participant Flow|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
10897814|NCT00553696|FG002|Participant Flow|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897815|NCT00553696|FG003|Participant Flow|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
11171736|NCT02005211|BG007|Baseline|Total|Total of all reporting groups
10897816|NCT00553696|OG000|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897817|NCT00553696|OG001|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (Dose Escalation Cohort)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily regimen for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897818|NCT00553696|OG002|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897819|NCT00553696|OG000|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
10897820|NCT00553696|OG000|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
11171737|NCT02005211|FG000|Participant Flow|Placebo Part 1|Placebo Part 1 - SAD
11171738|NCT02005211|FG001|Participant Flow|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
11171739|NCT02005211|FG002|Participant Flow|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
11171740|NCT02005211|FG003|Participant Flow|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
11171741|NCT02005211|FG004|Participant Flow|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
10897821|NCT00553696|OG001|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
10897822|NCT00553696|OG003|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
10897823|NCT00553696|EG000|Reported Event|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897824|NCT00553696|EG001|Reported Event|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
10897825|NCT00553696|EG002|Reported Event|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
10897826|NCT00553696|EG003|Reported Event|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
10897827|NCT00553735|BG000|Baseline|Arm I|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
10897828|NCT00553735|FG000|Participant Flow|All Study Participants|"Each eye of every participant was randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
10897829|NCT00553735|OG000|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
10897830|NCT00553735|OG001|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
10897831|NCT00553735|OG000|Outcome|Cyclosporine A 0.05%|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
10897832|NCT00553735|OG001|Outcome|Artificial Tear|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Artificial Tear three times a day for 18 months."
10897833|NCT00553735|EG000|Reported Event|Arm I|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
10897834|NCT00553787|BG000|Baseline|Placebo|
11171742|NCT02005211|FG005|Participant Flow|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
10897835|NCT00553787|BG001|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
10897836|NCT00553787|BG002|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
10897837|NCT00553787|BG003|Baseline|Total|Total of all reporting groups
10897838|NCT00553787|FG000|Participant Flow|Placebo|
10897839|NCT00553787|FG001|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
10897840|NCT00553787|FG002|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
10897841|NCT00553787|OG000|Outcome|Placebo|
10897842|NCT00553787|OG001|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
10897843|NCT00553787|OG002|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
11171743|NCT02005211|FG006|Participant Flow|Placebo Part 2|Placebo Part 2 - MAD
10897844|NCT00553787|EG000|Reported Event|Placebo|
10897845|NCT00553787|EG001|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
10897846|NCT00553787|EG002|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
10897847|NCT00553839|BG000|Baseline|Ketamine|"Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given.~ketamine hydrochloride: Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus."
10897848|NCT00553839|FG000|Participant Flow|Single Group Assignment|
10897849|NCT00553839|OG000|Outcome|Single Group Assignment|
10897850|NCT00553839|EG000|Reported Event|Single Group Assignment|
10897851|NCT00553969|BG000|Baseline|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
10897852|NCT00553969|BG001|Baseline|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
10897853|NCT00553969|BG002|Baseline|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
10897854|NCT00553969|BG003|Baseline|4 Placebo + Placebo|
10897855|NCT00553969|BG004|Baseline|Total|Total of all reporting groups
10897856|NCT00553969|FG000|Participant Flow|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
10897857|NCT00553969|FG001|Participant Flow|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
10897858|NCT00553969|FG002|Participant Flow|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
10897859|NCT00553969|FG003|Participant Flow|4 Placebo + Placebo|
11171744|NCT02005211|OG000|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
11171745|NCT02005211|OG001|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
10897860|NCT00553969|OG000|Outcome|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
10897861|NCT00553969|OG001|Outcome|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
10897862|NCT00553969|OG002|Outcome|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
10897863|NCT00553969|OG003|Outcome|4 Placebo + Placebo|
10897864|NCT00553969|EG000|Reported Event|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
10897865|NCT00553969|EG001|Reported Event|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
10897866|NCT00553969|EG002|Reported Event|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
10897867|NCT00553969|EG003|Reported Event|4 Placebo + Placebo|
10897868|NCT00554099|BG000|Baseline|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
10897869|NCT00554099|BG001|Baseline|Mesalamine|400 mg mesalamine (6 tablets daily)
10897870|NCT00554099|BG002|Baseline|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
10897871|NCT00554099|BG003|Baseline|Total|Total of all reporting groups
10897872|NCT00554099|FG000|Participant Flow|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
10897873|NCT00554099|FG001|Participant Flow|Mesalamine|400 mg mesalamine (6 tablets daily)
10897874|NCT00554099|FG002|Participant Flow|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
10897875|NCT00554099|OG000|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
10897876|NCT00554099|OG001|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
10897877|NCT00554099|OG002|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
10897878|NCT00554099|EG000|Reported Event|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
10897879|NCT00554099|EG001|Reported Event|Mesalamine|400 mg mesalamine (6 tablets daily)
10897880|NCT00554099|EG002|Reported Event|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
10897881|NCT00554216|BG000|Baseline|Placebo|
10897882|NCT00554216|BG001|Baseline|VI-0521 Low|PHEN/TPM 3.75/23
10897883|NCT00554216|BG002|Baseline|VI-0521 Top|PHEN/TPM 15/92
10897884|NCT00554216|BG003|Baseline|Total|Total of all reporting groups
10897885|NCT00554216|FG000|Participant Flow|Placebo|
10897886|NCT00554216|FG001|Participant Flow|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
10897887|NCT00554216|FG002|Participant Flow|VI-0521 Top|PHEN/TPM 15 mg/92 mg
10897888|NCT00554216|OG000|Outcome|Placebo|
10897889|NCT00554216|OG001|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
10897890|NCT00554216|OG002|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
10897891|NCT00554216|EG000|Reported Event|Placebo|
10897892|NCT00554216|EG001|Reported Event|VI-0521 Low|PHEN/TPM 3.75/23
10897893|NCT00554216|EG002|Reported Event|VI-0521 Top|PHEN/TPM 15/92
10897894|NCT00554229|BG000|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
11171746|NCT02005211|OG002|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
11171747|NCT02005211|OG003|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
11171748|NCT02005211|OG004|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
10897895|NCT00554229|BG001|Baseline|Placebo|Placebo oral tablet once daily
10897896|NCT00554229|BG002|Baseline|Total|Total of all reporting groups
10897897|NCT00554229|FG000|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
10897898|NCT00554229|FG001|Participant Flow|Placebo|Placebo oral tablet once daily
10897899|NCT00554229|OG000|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
10897900|NCT00554229|OG001|Outcome|Placebo|Placebo oral tablet once daily
10897901|NCT00554229|EG000|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
10897902|NCT00554229|EG001|Reported Event|Placebo|Placebo oral tablet once daily
10897903|NCT00554372|BG000|Baseline|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
10897904|NCT00554372|BG001|Baseline|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
10897905|NCT00554372|BG002|Baseline|Total|Total of all reporting groups
10897906|NCT00554372|FG000|Participant Flow|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
10897907|NCT00554372|FG001|Participant Flow|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
10897908|NCT00554372|OG000|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
10897909|NCT00554372|OG001|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
10897910|NCT00554372|OG000|Outcome|Low Dose|"1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)~JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
10897911|NCT00554372|OG001|Outcome|High Dose|"1e9 pfu (plaque-forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)~JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
10897912|NCT00554372|EG000|Reported Event|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
10897913|NCT00554372|EG001|Reported Event|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
10897914|NCT00554463|BG000|Baseline|Combined Modality Therapy With Growth Factor Support|Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
10897915|NCT00554463|FG000|Participant Flow|Combined Modality Therapy With Growth Factor Support|Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
10897916|NCT00554463|OG000|Outcome|Combined Modality Therapy With Growth Factor Support|Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
10897917|NCT00554463|EG000|Reported Event|Combined Modality Therapy With Growth Factor Support|Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
10897918|NCT00554515|BG000|Baseline|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
10897919|NCT00554515|FG000|Participant Flow|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
11171749|NCT02005211|OG000|Outcome|Placebo Part 1|Placebo Part 1 - SAD
11171750|NCT02005211|OG001|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
11171751|NCT02005211|OG002|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
11171752|NCT02005211|OG003|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
11171753|NCT02005211|OG004|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
11171754|NCT02005211|OG005|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
11171755|NCT02005211|OG006|Outcome|Placebo Part 2|Placebo Part 2 - MAD
11171756|NCT02005211|OG005|Outcome|Placebo Part 1|Placebo Part 1 - SAD
11171757|NCT02005211|OG006|Outcome|Placebo Part2|Placebo Part 2 - MAD
11171758|NCT02005211|EG000|Reported Event|Placebo Part 1|Placebo Part 1 - SAD
11171759|NCT02005211|EG001|Reported Event|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
10897920|NCT00554515|OG000|Outcome|ISM Good Risk Group|"ISM [Atkins et al CCR 2005]:~Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining~Pathology [Upton et al. J Immunother 2005] Good predictive pathology: clear-cell histology AND no papillary features AND >50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (>0%) alveolar features AND 50% granular features~CAIX [Bui et al. CCR 2003] High CAIX staining: >85% of CAIX positive tumor cells"
10897921|NCT00554515|OG000|Outcome|ISM Poor Risk Group|"ISM [Atkins et al CCR 2005]:~Poor predictive pathology OR the combination of intermediate predictive pathology and low CAIX staining~Pathology [Upton et al. J Immunother 2005] Poor predictive pathology: non-clear-cell histology OR some (>0%) papillary features OR no alveolar features OR >50% granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (>0%) alveolar features AND 50% granular features~CAIX [Bui et al. CCR 2003] Low CAIX staining: </=85% of CAIX positive tumor cells"
10897922|NCT00554515|OG000|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
10897923|NCT00554515|OG000|Outcome|Favorable MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
10897924|NCT00554515|OG001|Outcome|Intermediate MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
10897925|NCT00554515|OG002|Outcome|Poor MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
10897926|NCT00554515|OG000|Outcome|Low UCLA SANI Score|This tool predicts RCC patient's survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
10897927|NCT00554515|OG001|Outcome|Intermediate UCLA SANI Score|This tool predicts RCC patient's survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
10897928|NCT00554515|OG002|Outcome|High UCLA SANI Score|This tool predicts RCC patient's survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
10897929|NCT00554515|OG000|Outcome|Clear Cell Tumor Type|
10897930|NCT00554515|OG001|Outcome|Non-clear Cell Tumor Type|
11090623|NCT01529827|EG000|Reported Event|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
11090624|NCT01530178|BG000|Baseline|Placebo/Sitagliptin 25mg/Sitagliptin 50mg/Sitagliptin 100 mg|Each of the two study subjects underwent four study visits, three to four weeks apart; at each visit receiving either placebo, Sitagliptin 25 mg, Sitagliptin 50mg, or Sitagliptin 100mg.
11090625|NCT01530178|BG001|Baseline|Placebo/Sitagliptin 50mg/Sitagliptin 100 mg|Each of the six study subjects underwent three study visits, three to four weeks apart; at each visit receiving either placebo, Sitagliptin 50mg, or Sitagliptin 100mg.
11090626|NCT01530178|BG002|Baseline|Total|Total of all reporting groups
11090627|NCT01530178|FG000|Participant Flow|Placebo/Sitagliptin 25mg/Sitagliptin 50mg/Sitagliptin 100 mg|Each of the two study subjects underwent four study visits, three to four weeks apart; at each visit receiving either placebo, Sitagliptin 25 mg, Sitagliptin 50mg, or Sitagliptin 100mg.
11171760|NCT02005211|EG002|Reported Event|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
10897931|NCT00554515|OG000|Outcome|Good Clear Cell Histology Risk Group|
10897932|NCT00554515|OG001|Outcome|Intermediate Clear Cell Histology Risk Group|
10897933|NCT00554515|OG002|Outcome|Poor Clear Cell Histology Risk Group|
10897934|NCT00554515|OG000|Outcome|High CA-9 Score|This score is based on the expression of the CA 9 protein (encoded by the CA9 gene) assessed from patient's tumor specimen. CA 9 expression score is quantified by immunohistochemical analysis using CA9 monoclonal antibody (M75); High is >85% of CAIX positive tumor cells.
10897935|NCT00554515|OG001|Outcome|Low CA-9 Score|This score is based on the expression of the CA 9 protein (encoded by the CA9 gene) assessed from patient's tumor specimen. CA 9 expression score is quantified by immunohistochemical analysis using CA9 monoclonal antibody (M75); Low is </=85% of CAIX positive tumor cells
10897936|NCT00554515|OG000|Outcome|PD-L1 Tumor Negative|
10897937|NCT00554515|OG001|Outcome|PD-L1 Tumor Positive|
10897938|NCT00554515|OG000|Outcome|Negative|
10897939|NCT00554515|OG001|Outcome|Positive|
10897940|NCT00554515|OG000|Outcome|CA-9 SNP Homozygous|Patient's SNP (Single Nucleotide Polymorphism) status is determined by sequencing their tumor specimens. Patients are classified as homozygous or variant based on the observed nucleotide sequence.
10897941|NCT00554515|OG001|Outcome|CA-9 SNP Variant|Patient's SNP (Single Nucleotide Polymorphism) status is determined by sequencing their tumor specimens. Patients are classified as homozygous or variant based on the observed nucleotide sequence.
10897942|NCT00554515|EG000|Reported Event|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
10897943|NCT00554619|BG000|Baseline|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
10897944|NCT00554619|FG000|Participant Flow|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
10897945|NCT00554619|OG000|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
10897946|NCT00554619|EG000|Reported Event|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
10897947|NCT00554671|BG000|Baseline|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
10897948|NCT00554671|BG001|Baseline|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
10897949|NCT00554671|BG002|Baseline|Total|Total of all reporting groups
10897950|NCT00554671|FG000|Participant Flow|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
10897951|NCT00554671|FG001|Participant Flow|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
10897952|NCT00554671|OG000|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
10897953|NCT00554671|OG001|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
11090628|NCT01530178|FG001|Participant Flow|Placebo/Sitagliptin 50mg/Sitagliptin 100 mg|Each of the six study subjects underwent three study visits, three to four weeks apart; at each visit receiving either placebo, Sitagliptin 50mg, or Sitagliptin 100mg.
10897954|NCT00554671|OG000|Outcome|Pharmacist-led Group Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
10897955|NCT00554671|EG000|Reported Event|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
10897956|NCT00554671|EG001|Reported Event|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
10897957|NCT00554749|BG000|Baseline|Behavioral|All participants received identical behavioral treatment with no control group.
10897958|NCT00554749|FG000|Participant Flow|Behavioral|All participants received identical behavioral treatment with no control group.
10897959|NCT00554749|OG000|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
10897960|NCT00554749|EG000|Reported Event|Behavioral|All participants received identical behavioral treatment with no control group.
10897961|NCT00554788|BG000|Baseline|Stage 2/3 Patients|Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
10897962|NCT00554788|BG001|Baseline|Stage 4a Patients|Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
11090629|NCT01530178|OG000|Outcome|Sitagliptin 25 mg|Only two out of eight study subjects underwent four study visits, three to four weeks apart; at each visit receiving either Sitagliptin 25 mg, sitagliptin 50mg, sitagliptin 100mg or Placebo
11090630|NCT01530178|OG001|Outcome|Sitagliptin 50 mg|Each of the eight study subjects underwent three study visits, three to four weeks apart; at each visit receiving either Sitagliptin 25mg, sitagliptin 50mg, sitagliptin 100mg, or placebo
10897963|NCT00554788|BG002|Baseline|Stage 4b Patients|Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
10897964|NCT00554788|BG003|Baseline|Total|Total of all reporting groups
10897965|NCT00554788|FG000|Participant Flow|Stage 2/3 Patients|Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
10897966|NCT00554788|FG001|Participant Flow|Stage 4a Patients|Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
10897967|NCT00554788|FG002|Participant Flow|Stage 4b Patients|Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
10897968|NCT00554788|OG000|Outcome|Stage 2/3 Patients|Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
10897969|NCT00554788|OG001|Outcome|Stage 4a Patients|Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
10897970|NCT00554788|OG002|Outcome|Stage 4b Patients|Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
10897971|NCT00554788|OG000|Outcome|All Eligible Patients|All eligible Stage 2/3, Stage 4a, and Stage 4b patients
10897972|NCT00554788|EG000|Reported Event|Stage 2/3 Patients|Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
10897973|NCT00554788|EG001|Reported Event|Stage 4a Patients|Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
10897974|NCT00554788|EG002|Reported Event|Stage 4b Patients|Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
10897975|NCT00554801|BG000|Baseline|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
10897976|NCT00554801|BG001|Baseline|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
10897977|NCT00554801|BG002|Baseline|Total|Total of all reporting groups
10897978|NCT00554801|FG000|Participant Flow|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
10897979|NCT00554801|FG001|Participant Flow|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
10897980|NCT00554801|OG000|Outcome|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
10897981|NCT00554801|OG001|Outcome|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
10897982|NCT00554801|OG000|Outcome|Blast-exposed|Soldiers who have been exposed to one or more blasts
10897983|NCT00554801|OG001|Outcome|Controls|Individuals who have not experienced a blast
11090631|NCT01530178|OG002|Outcome|Sitagliptin 100 mg|Each of the eight study subjects underwent three study visits, three to four weeks apart; at each visit receiving either sitagliptin 25mg, sitagliptin 50mg, sitagliptin 100mg, or placebo
10897984|NCT00554801|EG000|Reported Event|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
10897985|NCT00554801|EG001|Reported Event|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
10897986|NCT00554853|BG000|Baseline|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone for 3 months compared to placebo for 3 months,crossover after a 2 month washout.
10897987|NCT00554853|BG001|Baseline|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to pioglitazone for 3 months, crossover after a 2 month washout.
10897988|NCT00554853|BG002|Baseline|Total|Total of all reporting groups
10897989|NCT00554853|FG000|Participant Flow|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone (study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
10897990|NCT00554853|FG001|Participant Flow|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) for 3 months.
10897991|NCT00554853|OG000|Outcome|Study Drug (Pioglitazone) Then Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
10897992|NCT00554853|OG001|Outcome|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
10897993|NCT00554853|OG000|Outcome|All Participants While on Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
10897994|NCT00554853|OG001|Outcome|All Participants While on Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
10897995|NCT00554853|EG000|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Drug|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
10897996|NCT00554853|EG001|Reported Event|Study Drug (Pioglitazone) Then Placebo, During Washout|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
10897997|NCT00554853|EG002|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Placebo|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
10897998|NCT00554853|EG003|Reported Event|Placebo Then Study Drug (Pioglitazone) While on Placebo|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
10897999|NCT00554853|EG004|Reported Event|Placebo Then Study Drug (Pioglitazone) During Washout|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
10898000|NCT00554853|EG005|Reported Event|Placebo Then Study Drug (Piolglitazone) While on Study Drug|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
10898001|NCT00554970|BG000|Baseline|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898002|NCT00554970|BG001|Baseline|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898003|NCT00554970|BG002|Baseline|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898004|NCT00554970|BG003|Baseline|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898005|NCT00554970|BG004|Baseline|Total|Total of all reporting groups
10898006|NCT00554970|FG000|Participant Flow|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898007|NCT00554970|FG001|Participant Flow|Treatment 2 Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898008|NCT00554970|FG002|Participant Flow|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
11171761|NCT02005211|EG003|Reported Event|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
11171762|NCT02005211|EG004|Reported Event|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
11171763|NCT02005211|EG005|Reported Event|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
10898009|NCT00554970|FG003|Participant Flow|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898010|NCT00554970|OG000|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
10898011|NCT00554970|OG001|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
10898012|NCT00554970|OG002|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
10898013|NCT00554970|OG003|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
10898014|NCT00554970|EG000|Reported Event|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898015|NCT00554970|EG001|Reported Event|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898016|NCT00554970|EG002|Reported Event|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898017|NCT00554970|EG003|Reported Event|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
10898018|NCT00554996|BG000|Baseline|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
10898019|NCT00554996|FG000|Participant Flow|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
10898020|NCT00554996|OG000|Outcome|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
10898021|NCT00554996|EG000|Reported Event|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
10898022|NCT00555048|BG000|Baseline|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10898023|NCT00555048|FG000|Participant Flow|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10898024|NCT00555048|OG000|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10898025|NCT00555048|EG000|Reported Event|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10898026|NCT00555061|BG000|Baseline|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
10898027|NCT00555061|FG000|Participant Flow|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
10898028|NCT00555061|OG000|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
10898029|NCT00555061|EG000|Reported Event|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
10898030|NCT00555152|BG000|Baseline|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
10898031|NCT00555152|BG001|Baseline|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
10898032|NCT00555152|BG002|Baseline|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
10898033|NCT00555152|BG003|Baseline|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
10898034|NCT00555152|BG004|Baseline|Total|Total of all reporting groups
10898035|NCT00555152|FG000|Participant Flow|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
10898036|NCT00555152|FG001|Participant Flow|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
10898037|NCT00555152|FG002|Participant Flow|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
10898038|NCT00555152|FG003|Participant Flow|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
10898039|NCT00555152|OG000|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
10898040|NCT00555152|OG001|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
10898041|NCT00555152|OG002|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
10898042|NCT00555152|OG003|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
10898043|NCT00555152|EG000|Reported Event|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
10898044|NCT00555152|EG001|Reported Event|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
10898045|NCT00555152|EG002|Reported Event|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
10898046|NCT00555152|EG003|Reported Event|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
10898047|NCT00555217|BG000|Baseline|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day~lisinopril: 10, 20 or 40 mg/day"
10898048|NCT00555217|BG001|Baseline|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day"
10898049|NCT00555217|BG002|Baseline|Total|Total of all reporting groups
10898050|NCT00555217|FG000|Participant Flow|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day~lisinopril: 10, 20 or 40 mg/day"
10898051|NCT00555217|FG001|Participant Flow|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day"
10898052|NCT00555217|OG000|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
10898053|NCT00555217|OG001|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
10898054|NCT00555217|EG000|Reported Event|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
10898055|NCT00555217|EG001|Reported Event|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
10898056|NCT00555321|BG000|Baseline|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
10898057|NCT00555321|BG001|Baseline|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
11090632|NCT01530178|OG003|Outcome|Placebo|Each of the eight study subjects were treated with placebo
10898058|NCT00555321|BG002|Baseline|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
10898059|NCT00555321|BG003|Baseline|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
10898060|NCT00555321|BG004|Baseline|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
10898061|NCT00555321|BG005|Baseline|Total|Total of all reporting groups
10898062|NCT00555321|FG000|Participant Flow|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
10898063|NCT00555321|FG001|Participant Flow|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
10898064|NCT00555321|FG002|Participant Flow|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
10898065|NCT00555321|FG003|Participant Flow|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
10898066|NCT00555321|FG004|Participant Flow|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
10898067|NCT00555321|OG000|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
10898068|NCT00555321|OG001|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
11090633|NCT01530178|EG000|Reported Event|Sitagliptin 25 mg|Each of the two study subjects underwent three study visits, three to four weeks apart; at each visit receiving either placebo, sitagliptin 50mg, or sitagliptin 100mg
11090634|NCT01530178|EG001|Reported Event|Sitagliptin 50 mg|Each of the eight study subjects underwent three study visits, three to four weeks apart; at each visit receiving either placebo, sitagliptin 50mg, or sitagliptin 100mg
11171764|NCT02005211|EG006|Reported Event|Placebo Part 2|Placebo Part 2 - MAD
10898069|NCT00555321|OG002|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
10898070|NCT00555321|OG003|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
10898071|NCT00555321|OG004|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
10898072|NCT00555321|OG000|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
10898073|NCT00555321|OG001|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
10898074|NCT00555321|OG002|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
10898075|NCT00555321|OG003|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
10898076|NCT00555321|OG004|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
10898077|NCT00555321|EG000|Reported Event|Basiliximab+Belatacept (MI)+Mycophenolate Mofetil (MMF)|
10898078|NCT00555321|EG001|Reported Event|MI+MMF|
10898079|NCT00555321|EG002|Reported Event|Belaticept (LI) + MMF|
10898080|NCT00555321|EG003|Reported Event|Tacrolimus|
10898081|NCT00555321|EG004|Reported Event|Tacrolimus + MMF|
10898082|NCT00555360|BG000|Baseline|Standard mHealth|Weekly IVR calls for 12 months
10898083|NCT00555360|BG001|Baseline|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
11090635|NCT01530178|EG002|Reported Event|Sitagliptin 100 mg|Each of the eight study subjects underwent three study visits, three to four weeks apart; at each visit receiving either placebo, sitagliptin 50mg, or sitagliptin 100mg
11090636|NCT01530178|EG003|Reported Event|Placebo|Each of the eight study subjects underwent three study visits, three to four weeks apart; at each visit receiving either placebo, sitagliptin 50mg, or sitagliptin 100mg
11090637|NCT01530243|BG000|Baseline|Placebo|Placebo: same as tolterodine and terazosin dose
11090638|NCT01530243|BG001|Baseline|Terazosin|Terazosine: 2 mg BID
11090639|NCT01530243|BG002|Baseline|Tolterodine|Tolterodine: 2 mg daily
11090640|NCT01530243|BG003|Baseline|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
10898084|NCT00555360|BG002|Baseline|Total|Total of all reporting groups
10898085|NCT00555360|FG000|Participant Flow|Standard mHealth|Weekly IVR calls for 12 months
10898086|NCT00555360|FG001|Participant Flow|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
10898087|NCT00555360|OG000|Outcome|Standard mHealth|Weekly IVR calls for 12 months
10898088|NCT00555360|OG001|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+CarePartner feedback
10898089|NCT00555360|OG001|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
10898090|NCT00555360|EG000|Reported Event|Standard mHealth|Weekly IVR calls for 12 months
10898091|NCT00555360|EG001|Reported Event|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
10898092|NCT00555425|BG000|Baseline|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
11090641|NCT01530243|BG004|Baseline|Total|Total of all reporting groups
11090642|NCT01530243|FG000|Participant Flow|Placebo|Placebo: same as tolterodine and terazosin dose
11090643|NCT01530243|FG001|Participant Flow|Terazosin|Terazosin: 2 mg BID
11090644|NCT01530243|FG002|Participant Flow|Tolterodine|Tolterodine: 2 mg daily
11090645|NCT01530243|FG003|Participant Flow|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
11090646|NCT01530243|OG000|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
11090647|NCT01530243|OG001|Outcome|Terazosin|Terazosine: 2 mg BID
11090648|NCT01530243|OG002|Outcome|Tolterodine|Tolterodine: 2 mg daily
11090649|NCT01530243|OG003|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
11090650|NCT01530243|OG001|Outcome|Terazosin|Terazosin: 2 mg BID
11090651|NCT01530243|EG000|Reported Event|Placebo|Placebo: same as tolterodine and terazosin dose
11090652|NCT01530243|EG001|Reported Event|Terazosin|Terazosin: 2 mg BID
11090653|NCT01530243|EG002|Reported Event|Tolterodine|Tolterodine: 2 mg daily
10898093|NCT00555425|BG001|Baseline|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
10898094|NCT00555425|BG002|Baseline|Total|Total of all reporting groups
10898095|NCT00555425|FG000|Participant Flow|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
10898096|NCT00555425|FG001|Participant Flow|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
10898097|NCT00555425|OG000|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
10898098|NCT00555425|OG001|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
10898099|NCT00555425|EG000|Reported Event|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
10898100|NCT00555425|EG001|Reported Event|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
10898101|NCT00555438|BG000|Baseline|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
10898102|NCT00555438|FG000|Participant Flow|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
10898103|NCT00555438|OG000|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
10898104|NCT00555438|EG000|Reported Event|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
10898105|NCT00555464|BG000|Baseline|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
10898106|NCT00555464|BG001|Baseline|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
10898107|NCT00555464|BG002|Baseline|Total|Total of all reporting groups
10898108|NCT00555464|FG000|Participant Flow|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
10898109|NCT00555464|FG001|Participant Flow|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
10898110|NCT00555464|OG000|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
10898111|NCT00555464|OG001|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
10898112|NCT00555464|EG000|Reported Event|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
10898113|NCT00555464|EG001|Reported Event|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
10898114|NCT00555477|BG000|Baseline|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
10898115|NCT00555477|BG001|Baseline|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
10898116|NCT00555477|BG002|Baseline|Total|Total of all reporting groups
10898117|NCT00555477|FG000|Participant Flow|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH (Follicle-stimulating hormone) concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
10898118|NCT00555477|FG001|Participant Flow|Anastrozole Part 2|During the conduct of the trial the study was amended to change the eligibility criteria because of difficulties with the estradiol assay. Subjects enrolled after the amendment were required to sign consent and then have an average baseline estradiol concentration of ≤20 pg/ml in order to be considered eligible.
10898119|NCT00555477|OG000|Outcome|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
10898120|NCT00555477|OG001|Outcome|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
10898121|NCT00555477|EG000|Reported Event|Anastrozole|anastrozole: 1 mg tablet by mouth once a day
10898122|NCT00555568|BG000|Baseline|Arm 1: Peer-Led Group|"Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators~recovery oriented mental health peer support group: This is a recovery-focused mental health education and support group led by peer facilitators"
11090654|NCT01530243|EG003|Reported Event|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
10898123|NCT00555568|BG001|Baseline|Arm 2: Clinician-Led Group|"Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician~recovery-oriented mental health clinician-led group: This is a recovery-focused mental health education and support group led by a mental health clinician"
10898124|NCT00555568|BG002|Baseline|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
10898125|NCT00555568|BG003|Baseline|Total|Total of all reporting groups
10898126|NCT00555568|FG000|Participant Flow|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
10898127|NCT00555568|FG001|Participant Flow|Arm 2: Clinician Led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
10898128|NCT00555568|FG002|Participant Flow|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
10898129|NCT00555568|OG000|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
10898130|NCT00555568|OG001|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
10898131|NCT00555568|OG002|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
10898132|NCT00555568|EG000|Reported Event|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
10898133|NCT00555568|EG001|Reported Event|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
10898134|NCT00555568|EG002|Reported Event|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
10898135|NCT00555581|BG000|Baseline|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
10898136|NCT00555581|FG000|Participant Flow|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
10898137|NCT00555581|OG000|Outcome|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
10898138|NCT00555581|EG000|Reported Event|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
10898139|NCT00555620|BG000|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
10898140|NCT00555620|BG001|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898141|NCT00555620|BG002|Baseline|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898142|NCT00555620|BG003|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898143|NCT00555620|BG004|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898144|NCT00555620|BG005|Baseline|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898145|NCT00555620|BG006|Baseline|Total|Total of all reporting groups
10898146|NCT00555620|FG000|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
10898147|NCT00555620|FG001|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898148|NCT00555620|FG002|Participant Flow|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
11090655|NCT01530256|BG000|Baseline|ALD518|ALD518: 160 mg IV q 4 weeks for 4 doses
10898149|NCT00555620|FG003|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898150|NCT00555620|FG004|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898151|NCT00555620|FG005|Participant Flow|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898152|NCT00555620|OG000|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
10898153|NCT00555620|OG001|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898154|NCT00555620|OG002|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898155|NCT00555620|OG003|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898156|NCT00555620|OG004|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898157|NCT00555620|OG005|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898158|NCT00555620|OG000|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898159|NCT00555620|OG001|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898160|NCT00555620|OG002|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898161|NCT00555620|OG004|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898162|NCT00555620|EG000|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
10898163|NCT00555620|EG001|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
11090656|NCT01530256|FG000|Participant Flow|ALD518|ALD518: 160 mg intravenous (IV) once every (q) 4 weeks for 4 doses
10898164|NCT00555620|EG002|Reported Event|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898165|NCT00555620|EG003|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898166|NCT00555620|EG004|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898167|NCT00555620|EG005|Reported Event|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
10898168|NCT00555672|BG000|Baseline|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
10898169|NCT00555672|BG001|Baseline|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
10898170|NCT00555672|BG002|Baseline|Total|Total of all reporting groups
10898171|NCT00555672|FG000|Participant Flow|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
10898172|NCT00555672|FG001|Participant Flow|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
11090657|NCT01530256|OG000|Outcome|ALD518|ALD518: 160 mg IV q 4 weeks for 4 doses
11090658|NCT01530256|EG000|Reported Event|ALD518|ALD518: 160 mg IV q 4 weeks for 4 doses
10898173|NCT00555672|OG000|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
10898174|NCT00555672|OG001|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
10898175|NCT00555672|EG000|Reported Event|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
10898176|NCT00555672|EG001|Reported Event|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
10898177|NCT00555750|BG000|Baseline|Active|active medication administration nightly before bed
10898178|NCT00555750|BG001|Baseline|Placebo|nightly administration of placebo before bed
10898179|NCT00555750|BG002|Baseline|Total|Total of all reporting groups
10898180|NCT00555750|FG000|Participant Flow|Eszopiclone|nightly active medication (eszopiclone, 3 mg tablet) oral administration ~30 min before bed
10898181|NCT00555750|FG001|Participant Flow|Placebo|nightly placebo (identical tablet to active medication) oral administration ~30 min before bed
10898182|NCT00555750|OG000|Outcome|Active|active medication administration nightly before bed
10898183|NCT00555750|OG001|Outcome|Placebo|nightly administration of placebo before bed
10898184|NCT00555750|EG000|Reported Event|Active|active medication administration nightly before bed
10898185|NCT00555750|EG001|Reported Event|Placebo|nightly administration of placebo before bed
10898186|NCT00555880|BG000|Baseline|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl followed by matching Placebo the next day
10898187|NCT00555880|BG001|Baseline|Placebo/Midodrine|Participants received matching Placebo followed by a single oral dose of Midodrine HCl the next day
10898188|NCT00555880|BG002|Baseline|Total|Total of all reporting groups
10898189|NCT00555880|FG000|Participant Flow|Midodrine/Placebo|Participants received a single oral dose of Midodrine hydrochloride (HCl) followed by matching Placebo the next day
10898190|NCT00555880|FG001|Participant Flow|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl the next day
10898191|NCT00555880|OG000|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
10898192|NCT00555880|OG001|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
10898193|NCT00555880|OG000|Outcome|All Participants|All randomized participants
10898194|NCT00555880|EG000|Reported Event|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl (10-30mg) followed by placebo the next day.
10898195|NCT00555880|EG001|Reported Event|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl (10-30mg) the next day.
10898196|NCT00555893|BG000|Baseline|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
10898197|NCT00555893|BG001|Baseline|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
10898198|NCT00555893|BG002|Baseline|Total|Total of all reporting groups
10898199|NCT00555893|FG000|Participant Flow|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
10898200|NCT00555893|FG001|Participant Flow|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
11090659|NCT01530334|BG000|Baseline|Gefitinib|250 mg/die, oral
11090660|NCT01530334|FG000|Participant Flow|Gefitinib|250 mg/die, oral
11090661|NCT01530334|OG000|Outcome|Gefitinib|250 mg/die, oral
11090662|NCT01530334|EG000|Reported Event|Gefitinib|250 mg/die, oral
10898201|NCT00555893|OG000|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
10898202|NCT00555893|OG001|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
10898203|NCT00555893|EG000|Reported Event|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
10898204|NCT00555893|EG001|Reported Event|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
10898205|NCT00555906|BG000|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898206|NCT00555906|BG001|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898207|NCT00555906|BG002|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898208|NCT00555906|BG003|Baseline|Total|Total of all reporting groups
10898209|NCT00555906|FG000|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 milligram (mg) capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 milligram per square meter (mg/m^2) intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
11171765|NCT02005250|BG000|Baseline|Hyperthyroidism|46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism
11171766|NCT02005250|BG001|Baseline|Hypothyroidism|27 women with overt or subclinical autoimmune hypothyroidism
11171767|NCT02005250|BG002|Baseline|Total|Total of all reporting groups
10898210|NCT00555906|FG001|Participant Flow|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898211|NCT00555906|FG002|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898212|NCT00555906|FG003|Participant Flow|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898213|NCT00555906|FG004|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898214|NCT00555906|OG000|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898215|NCT00555906|OG001|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898216|NCT00555906|OG000|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
11171768|NCT02005250|FG000|Participant Flow|Hyperthyroidism|46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism
11171769|NCT02005250|FG001|Participant Flow|Hypothyroidism|27 women with overt or subclinical autoimmune hypothyroidism
11171770|NCT02005250|OG000|Outcome|Hyperthyroidism|46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism
11171771|NCT02005250|OG001|Outcome|Hypothyroidism|27 women with overt or subclinical autoimmune hypothyroidism
10898217|NCT00555906|OG000|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898218|NCT00555906|OG001|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898219|NCT00555906|OG002|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898220|NCT00555906|OG003|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898221|NCT00555906|OG000|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898222|NCT00555906|EG000|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898223|NCT00555906|EG001|Reported Event|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10914807|NCT00632814|FG000|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
11171772|NCT02005250|EG000|Reported Event|Hyperthyroidism|46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism
11090663|NCT01530399|BG000|Baseline|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
10898224|NCT00555906|EG002|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898225|NCT00555906|EG003|Reported Event|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898226|NCT00555906|EG004|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
10898227|NCT00555971|BG000|Baseline|Placebo|"Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.~placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis"
10898228|NCT00555971|BG001|Baseline|Omalizumab|"Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.~Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis"
10898229|NCT00555971|BG002|Baseline|Total|Total of all reporting groups
10898230|NCT00555971|FG000|Participant Flow|Placebo|"Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.~placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis"
10898231|NCT00555971|FG001|Participant Flow|Omalizumab|"Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.~Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis"
10898232|NCT00555971|OG000|Outcome|Placebo|"Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.~placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis"
10898233|NCT00555971|OG001|Outcome|Omalizumab|"Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.~Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis"
10898234|NCT00555971|EG000|Reported Event|Placebo|"Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.~placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis"
10898235|NCT00555971|EG001|Reported Event|Omalizumab|"Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.~Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis"
10898236|NCT00555997|BG000|Baseline|Placebo/Ziprasidone|Received placebo in first phase and ziprasidone in second phase
10898237|NCT00555997|BG001|Baseline|Placebo|Subjects received placebo throughout study
10898238|NCT00555997|BG002|Baseline|Ziprasidone|Subjects received ziprasidone throughout study
10898239|NCT00555997|BG003|Baseline|Total|Total of all reporting groups
10898240|NCT00555997|FG000|Participant Flow|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
10898241|NCT00555997|FG001|Participant Flow|Phase 1 Placebo|Subjects taking placebo in the first phase.
10898242|NCT00555997|FG002|Participant Flow|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
10898243|NCT00555997|FG003|Participant Flow|Phase 2 Placebo|Patients who received placebo in phase 2.
10898244|NCT00555997|OG000|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
10898245|NCT00555997|OG001|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
10898246|NCT00555997|OG002|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
10898247|NCT00555997|OG003|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
10898248|NCT00555997|OG000|Outcome|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
11171773|NCT02005250|EG001|Reported Event|Hypothyroidism|27 women with overt or subclinical autoimmune hypothyroidism
10898249|NCT00555997|OG001|Outcome|Phase 1 Placebo|Subjects taking placebo in the first phase.
10898250|NCT00555997|OG002|Outcome|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
10898251|NCT00555997|OG003|Outcome|Phase 2 Placebo|Patients who received placebo in phase 2.
10898252|NCT00555997|EG000|Reported Event|Ziprasidone|Adverse events experienced by subjects while taking ziprasidone
10898253|NCT00555997|EG001|Reported Event|Placebo|Adverse events experienced when taking placebo
10898254|NCT00556049|BG000|Baseline|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
10898255|NCT00556049|FG000|Participant Flow|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
10898256|NCT00556049|OG000|Outcome|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
10898257|NCT00556049|EG000|Reported Event|Neutropenia|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
10898258|NCT00556140|BG000|Baseline|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
10898259|NCT00556140|FG000|Participant Flow|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
10898260|NCT00556140|OG000|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
10898261|NCT00556140|EG000|Reported Event|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
10898262|NCT00556322|BG000|Baseline|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
10898263|NCT00556322|BG001|Baseline|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
10898264|NCT00556322|BG002|Baseline|Total|Total of all reporting groups
10898265|NCT00556322|FG000|Participant Flow|Comparator|Participants received either pemetrexed 500 milligrams per square meter (mg/m^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
10898266|NCT00556322|FG001|Participant Flow|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
10898267|NCT00556322|OG000|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
10898268|NCT00556322|OG001|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
10914808|NCT00632814|FG001|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
10914809|NCT00632814|FG002|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
11171774|NCT02005276|BG000|Baseline|Control|Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day.
10898269|NCT00556322|OG000|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel l75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
10898270|NCT00556322|OG000|Outcome|Comparator|Participants received either pemetrexed500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable t oxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
10898271|NCT00556322|OG001|Outcome|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day as a tablet until disease progression, unacceptable toxicity or death.
10898272|NCT00556322|EG000|Reported Event|Comparator|Participants received either Alimta 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or Taxotere 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, Taxotere was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
10898273|NCT00556322|EG001|Reported Event|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day until disease progression, unacceptable toxicity or death.
10898274|NCT00556374|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
10898275|NCT00556374|BG001|Baseline|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
10898276|NCT00556374|BG002|Baseline|Total|Total of all reporting groups
10898277|NCT00556374|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
10898278|NCT00556374|FG001|Participant Flow|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
10898279|NCT00556374|OG000|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
10898280|NCT00556374|OG001|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
10898281|NCT00556374|EG000|Reported Event|Placebo Q6M|Participants received placebo subcutaneous injection once every 6 months (Q6M). All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
10898282|NCT00556374|EG001|Reported Event|Denosumab 60mg Q6M|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy
10898283|NCT00556426|BG000|Baseline|Participants Receiving a Filter|Patients who were at temporary, increased risk of pulmonary embolism requiring inferior vena cava (IVC) interruption, and for whom Recovery G2 Filter retrieval could reasonably be expected to occur within 6 months of device placement.
10898284|NCT00556426|FG000|Participant Flow|All Patients Receiving the Filter|All enrolled subjects
10898285|NCT00556426|OG000|Outcome|All Patients Receiving the Filter|All enrolled subjects
10898286|NCT00556426|OG000|Outcome|Fractured Filters|retrieval of the filter such that the entire filter is retrieved
10898287|NCT00556426|EG000|Reported Event|All Patients Receiving the Filter|All enrolled subjects
11090664|NCT01530399|BG001|Baseline|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
10898288|NCT00556439|BG000|Baseline|Group A - Abatacept in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A."
10914810|NCT00632814|OG000|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
10914811|NCT00632814|OG001|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
10898289|NCT00556439|BG001|Baseline|Group B - Placebo in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B."
10898290|NCT00556439|BG002|Baseline|Group C - Abatacept in Takayasu Arteritis|"This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C."
10898291|NCT00556439|BG003|Baseline|Group D - Placebo in Takayasu Arteritis|"This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D."
10898292|NCT00556439|BG004|Baseline|Total|Total of all reporting groups
10898293|NCT00556439|FG000|Participant Flow|Group A - Abatacept in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. Participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A."
10898294|NCT00556439|FG001|Participant Flow|Group B - Placebo in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B."
10898295|NCT00556439|FG002|Participant Flow|Group C - Abatacept in Takayasu Arteritis|"This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C."
10914812|NCT00632814|OG002|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
11090665|NCT01530399|BG002|Baseline|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
11090666|NCT01530399|BG003|Baseline|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
10898296|NCT00556439|FG003|Participant Flow|Group D - Placebo in Takayasu Arteritis|"This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D."
10898297|NCT00556439|OG000|Outcome|Group A - Abatacept in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. Participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A."
10898298|NCT00556439|OG001|Outcome|Group B - Placebo in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B."
10898299|NCT00556439|OG002|Outcome|Group C - Abatacept in Takayasu Arteritis|"This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C."
10898300|NCT00556439|OG003|Outcome|Group D - Placebo in Takayasu Arteritis|"This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D."
10898301|NCT00556439|EG000|Reported Event|Group A - Abatacept in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. Participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A."
10914813|NCT00632814|EG000|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
11090667|NCT01530399|BG004|Baseline|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
11090668|NCT01530399|BG005|Baseline|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
11090669|NCT01530399|BG006|Baseline|Total|Total of all reporting groups
10898302|NCT00556439|EG001|Reported Event|Group B - Placebo in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B."
10898303|NCT00556439|EG002|Reported Event|Group C - Abatacept in Takayasu Arteritis|"This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C."
10898304|NCT00556439|EG003|Reported Event|Group D - Placebo in Takayasu Arteritis|"This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D."
10898305|NCT00556452|BG000|Baseline|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
10898306|NCT00556452|BG001|Baseline|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
10898307|NCT00556452|BG002|Baseline|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
10898308|NCT00556452|BG003|Baseline|Total|Total of all reporting groups
10898309|NCT00556452|FG000|Participant Flow|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
10898310|NCT00556452|FG001|Participant Flow|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
10898311|NCT00556452|FG002|Participant Flow|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
10898312|NCT00556452|OG000|Outcome|Clo/Bu4|Experimental: Clo/BU4
10898313|NCT00556452|OG000|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.~After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.~Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant~Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)~1st dose level: 20 mg/m2/day x 5 days~2nd dose level: 30 mg/m2/day x 5 days~3rd dose level: 40 mg/m2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
11090670|NCT01530399|FG000|Participant Flow|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
10898314|NCT00556452|EG000|Reported Event|Clo/Bu4|
10898315|NCT00556478|BG000|Baseline|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
11357155|NCT03764449|OG000|Outcome|Cohort 1, Period 1|Participants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10898316|NCT00556478|BG001|Baseline|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898317|NCT00556478|BG002|Baseline|Total|Total of all reporting groups
10898318|NCT00556478|FG000|Participant Flow|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898319|NCT00556478|FG001|Participant Flow|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898320|NCT00556478|OG000|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898321|NCT00556478|OG001|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898322|NCT00556478|OG000|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898323|NCT00556478|OG001|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10914814|NCT00632814|EG001|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
11090671|NCT01530399|FG001|Participant Flow|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
10898324|NCT00556478|EG000|Reported Event|Double-Blind Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898325|NCT00556478|EG001|Reported Event|Double-Blind Placebo|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898326|NCT00556478|EG002|Reported Event|Open Label Phase|"Subjects will all receive PSD502 if they wish to continue in the trial.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
10898327|NCT00556491|BG000|Baseline|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
10898328|NCT00556491|BG001|Baseline|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
10898329|NCT00556491|BG002|Baseline|Total|Total of all reporting groups
10898330|NCT00556491|FG000|Participant Flow|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
10898331|NCT00556491|FG001|Participant Flow|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
10898332|NCT00556491|OG000|Outcome|Minocycline|
10898333|NCT00556491|OG001|Outcome|Placebo|
10898334|NCT00556491|OG000|Outcome|Minocycline|Post Op hospital days
10898335|NCT00556491|OG001|Outcome|Placebo|Post op hospital days
10898336|NCT00556491|OG000|Outcome|Minocycline|On vent > 48 hours
10898337|NCT00556491|OG001|Outcome|Placebo|On vent > 48 hours
10898338|NCT00556491|OG000|Outcome|Minocycline|Infections post-operative
10898339|NCT00556491|OG001|Outcome|Placebo|Infections post-operative
10898340|NCT00556491|OG000|Outcome|Minocycline|Stroke post-op
10898341|NCT00556491|OG001|Outcome|Placebo|stroke post op
10898342|NCT00556491|OG000|Outcome|Minocycline|re-operation
10898343|NCT00556491|OG001|Outcome|Placebo|re-operation
10898344|NCT00556491|EG000|Reported Event|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
11171775|NCT02005276|BG001|Baseline|Basic Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day.~Basic Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day."
10898345|NCT00556491|EG001|Reported Event|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
10898346|NCT00556504|BG000|Baseline|TCM-700C|TCM-700C, an add-on drug to conventional treatment of Hepatitis C
10898347|NCT00556504|BG001|Baseline|Placebo|Placebo with convetional treatment for HCV patients
10898348|NCT00556504|BG002|Baseline|Total|Total of all reporting groups
10898349|NCT00556504|FG000|Participant Flow|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
10898350|NCT00556504|FG001|Participant Flow|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
10898351|NCT00556504|OG000|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
10898352|NCT00556504|OG001|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
10898353|NCT00556504|EG000|Reported Event|TCM-700C (Safety Population)|TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C
10898354|NCT00556504|EG001|Reported Event|Placebo (Safety Population)|Placebo with convetional treatment(PegIFN plus RBV) for HCV patients
10898355|NCT00556543|BG000|Baseline|All Study Subjects|
10898356|NCT00556543|FG000|Participant Flow|All Study Subjects|
10898357|NCT00556543|OG000|Outcome|Acute Rib Fracture Repair|These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.
10898358|NCT00556543|OG001|Outcome|Rib Fracture Repair for Persistent Rib Fracture Non-Union|Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
10898359|NCT00556543|OG000|Outcome|All Study Subjects|
10898360|NCT00556543|EG000|Reported Event|Acute Rib Fracture Repair|
10898361|NCT00556543|EG001|Reported Event|Chronic Rib Fracture Non-union Repair|
10898362|NCT00556673|BG000|Baseline|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
10898363|NCT00556673|BG001|Baseline|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
10898364|NCT00556673|BG002|Baseline|Total|Total of all reporting groups
10898365|NCT00556673|FG000|Participant Flow|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
10898366|NCT00556673|FG001|Participant Flow|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
10898367|NCT00556673|OG000|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
10898368|NCT00556673|OG001|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
10898369|NCT00556673|OG002|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
10898370|NCT00556673|EG000|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
10898371|NCT00556673|EG001|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
11335632|NCT03554005|EG005|Reported Event|PEG Interferon Alfa-2b 7.5 mcg/kg OW|Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
10898372|NCT00556673|EG002|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
10898373|NCT00556712|BG000|Baseline|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
10898374|NCT00556712|BG001|Baseline|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
10898375|NCT00556712|BG002|Baseline|Total|Total of all reporting groups
10898376|NCT00556712|FG000|Participant Flow|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
11090672|NCT01530399|FG002|Participant Flow|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
11090673|NCT01530399|FG003|Participant Flow|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
11090674|NCT01530399|FG004|Participant Flow|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
10898377|NCT00556712|FG001|Participant Flow|Erlotinib, 150 Milligrams Per Day (mg/Day)|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
10898378|NCT00556712|OG000|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
10898379|NCT00556712|OG001|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
10898380|NCT00556712|EG000|Reported Event|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
10898381|NCT00556712|EG001|Reported Event|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
10914815|NCT00632814|EG002|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
10914816|NCT00632827|BG000|Baseline|Treatment Plan|(1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days 1, 8, Navelbine 20 mg/m2 day 1, 8; Doxil 15 mg/m2 Days 1, 8, Granulocyte-colony stimulating factor(G-CSF) Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day 1-6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion day 0 (7) Post-transplant: Denileukin diftitox
10914817|NCT00632827|FG000|Participant Flow|Treatment Plan|"All patients will be given allopurinol 600 mg/day PO on day 1 of induction chemotherapy, and then 300 mg/day.~Patients then receive two cycles of gemcitabine, vinorelbine, Doxil (GVD) followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose Methotrexate (MTX). Patients were restaged after 2 cycles of GVD and again after the second cycle of augmented CHOP/high-dose MTX.~Those achieving a remission status received intensive consolidation with Idarubicin/cytosine arabinoside(iDAC)/etoposide followed by stem cell mobilization and 5-day course of denileukin diftitox (Ontak) will be administered followed by autologous stem cell transplant.~Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen moved to consolidation/mobilization and autologous stem cell transplant."
10914818|NCT00632827|OG000|Outcome|Treatment Plan|(1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days 1, 8, Navelbine 20 mg/m2 day 1, 8; Doxil 15 mg/m2 Days 1 and 8, G-CSF Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day -6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion day 0 (7) Post-transplant: Denileukin Diftitox (Ontak) 18 mcg/kg/day days 1- 5
10914819|NCT00632827|OG000|Outcome|Treatment Plan|"All patients will be given allopurinol 600 mg/day PO on day 1 of induction chemotherapy, and then 300 mg/day.~Patients then receive two cycles of gemcitabine, vinorelbine, Doxil (GND) followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose Methotrexate (MTX). Patients were restaged after 2 cycles of GND and again after the second cycle of augmented CHOP/high-dose MTX.~Those achieving a remission status received intensive consolidation with iDAC/etoposide followed by stem cell mobilization and 5-day course of denileukin diftitox (Ontak) will be administered followed by autologous stem cell transplant.~Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen moved to consolidation/mobilization and autologous stem cell transplant."
11090675|NCT01530399|FG005|Participant Flow|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
11357156|NCT03764449|OG001|Outcome|Cohort 1, Period 2|Participants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10898382|NCT00556842|BG000|Baseline|Total Hip Arthroplasty|"Participants will undergo total hip arthroplasty.~Total hip arthroplasty: Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion."
10898383|NCT00556842|BG001|Baseline|Hemi-Arthroplasty|"Participants will undergo hemi-arthroplasty.~Hemi-arthroplasty: Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion."
10898384|NCT00556842|BG002|Baseline|Total|Total of all reporting groups
10898385|NCT00556842|FG000|Participant Flow|Total Hip Arthroplasty|"Participants will undergo total hip arthroplasty.~Total hip arthroplasty: Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion."
10898386|NCT00556842|FG001|Participant Flow|Hemi-arthroplasty|"Participants will undergo hemi-arthroplasty.~Hemi-arthroplasty: Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion."
10898387|NCT00556842|OG000|Outcome|Total Hip Arthroplasty|"Participants will undergo total hip arthroplasty.~Total hip arthroplasty: Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion."
10898388|NCT00556842|OG001|Outcome|Hemi-arthroplasty|"Participants will undergo hemi-arthroplasty.~Hemi-arthroplasty: Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion."
10898389|NCT00556842|OG000|Outcome|Total Hip Arthroplasty|WOMAC scores for the THA group at 24 months.
10898390|NCT00556842|OG001|Outcome|Hemiarthroplasty|WOMAC scores for the HA group at 24 months.
10898391|NCT00556842|OG000|Outcome|Total Hip Arthroplasty|THA Participants who took more than 12 seconds to complete the TUG test or were unable to complete the test.
10898392|NCT00556842|OG001|Outcome|Hemiarthroplasty|HA Participants who took more than 12 seconds to complete the TUG test or were unable to complete the test.
10898393|NCT00556842|OG000|Outcome|Total Hip Arthroplasty|SF-12 scores for the THA group at 24 months.
10898394|NCT00556842|OG001|Outcome|Hemiarthroplasty|SF-12 scores for the HA group at 24 months.
10898395|NCT00556842|OG000|Outcome|Total Hip Arthroplasty|EQ-5D scores for the THA group at 24 months.
10898396|NCT00556842|OG001|Outcome|Hemiarthroplasty|EQ-5D scores for the HA group at 24 months.
10898397|NCT00556842|EG000|Reported Event|Total Hip Arthroplasty|"Participants will undergo total hip arthroplasty.~Total hip arthroplasty: Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion."
11090676|NCT01530399|OG000|Outcome|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
10898398|NCT00556842|EG001|Reported Event|Hemi-arthroplasty|"Participants will undergo hemi-arthroplasty.~Hemi-arthroplasty: Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion."
10898399|NCT00556894|BG000|Baseline|CF101 0.1mg|CF101: orally q12h
10898400|NCT00556894|BG001|Baseline|CF101 1mg|CF101: orally q12h
10898401|NCT00556894|BG002|Baseline|Placebo|CF101: orally q12h
10898402|NCT00556894|BG003|Baseline|Total|Total of all reporting groups
10898403|NCT00556894|FG000|Participant Flow|CF101 0.1mg|CF101 0.1mg orally q12 for 12 weeks
10898404|NCT00556894|FG001|Participant Flow|CF101 1mg|CF101 1mg orally q12 for 12 weeks
10898405|NCT00556894|FG002|Participant Flow|Placebo|Matching placebo
10898406|NCT00556894|OG000|Outcome|CF101 0.1mg|CF101 0.1mg orally q12
10898407|NCT00556894|OG001|Outcome|CF101 1mg|CF101 1mg orally q12
10898408|NCT00556894|OG002|Outcome|Placebo|Placebo orally q12
10898409|NCT00556894|EG000|Reported Event|CF101 0.1mg|CF101 0.1mg q12 for 12 weeks
10898410|NCT00556894|EG001|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
10898411|NCT00556894|EG002|Reported Event|Placebo|Matching Placebo q12 for 12 weeks
11090677|NCT01530399|OG001|Outcome|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
11090678|NCT01530399|OG002|Outcome|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
10898412|NCT00556933|BG000|Baseline|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg of rATG as a single dose administered intravenously over <24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
10898413|NCT00556933|BG001|Baseline|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
10898414|NCT00556933|BG002|Baseline|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant receive the same treatment as in Group 1, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
10898415|NCT00556933|BG003|Baseline|Divided-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofeti|"Kidney transplant receive the same treatment as in Group 2, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.."
10898416|NCT00556933|BG004|Baseline|Total|Total of all reporting groups
10898417|NCT00556933|FG000|Participant Flow|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) (6 mg/kg) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
10898418|NCT00556933|FG001|Participant Flow|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|Kidney transplant recipients given 4 small doses (1.5 mg/kg) of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
10898419|NCT00556933|FG002|Participant Flow|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG, 6 mg/kg x 1) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
10898420|NCT00556933|FG003|Participant Flow|Divided-dose rATG (1.5mg/kgx4),Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG, 1.5 mg/kg x 4) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
10898421|NCT00556933|OG000|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
10898422|NCT00556933|OG001|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
10915183|NCT00634270|OG000|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
10898423|NCT00556933|OG002|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
10898424|NCT00556933|OG003|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
10898425|NCT00556933|OG002|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
10898426|NCT00556933|OG003|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
10898427|NCT00556933|OG002|Outcome|Ingle-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
10898428|NCT00556933|OG003|Outcome|Divided-dose rATG(1.5mg/kgx4), Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
10898429|NCT00556933|OG003|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
10915184|NCT00634270|EG000|Reported Event|Stratum 1|"Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity with evidence of progression.~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Disease status will be evaluated using volumetric MRI analysis at regular intervals."
10898430|NCT00556933|OG000|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
10898431|NCT00556933|OG002|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
10898432|NCT00556933|OG002|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
10898433|NCT00556933|OG003|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
10898434|NCT00556933|EG000|Reported Event|Group 1|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
10898435|NCT00556933|EG001|Reported Event|Group 2|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
10898436|NCT00556933|EG002|Reported Event|Group 3|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
10915185|NCT00634270|EG001|Reported Event|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
10915186|NCT00634283|BG000|Baseline|Venlafaxine IR (Effexor)|Five weeks of treatment with venlafaxine IR
10915187|NCT00634283|FG000|Participant Flow|Venlafaxine IR (Effexor)|Five weeks of treatment with venlafaxine IR
10898437|NCT00556933|EG003|Reported Event|Group 4|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
10898438|NCT00556946|BG000|Baseline|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser.
10898439|NCT00556946|FG000|Participant Flow|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains: using Combined Photodynamic and Pulsed Dye Laser.
10898440|NCT00556946|OG000|Outcome|Treatment of Port Wine Stains|"Treatment of Port Wine Stains~Treatment of Port Wine Stains: Treatment of Port Wine Stains"
10898441|NCT00556946|EG000|Reported Event|Treatment of Port Wine Stains|"Treatment of Port Wine Stains~Treatment of Port Wine Stains: Treatment of Port Wine Stains"
10898442|NCT00556972|BG000|Baseline|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
10898443|NCT00556972|FG000|Participant Flow|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
10898444|NCT00556972|OG000|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
10898445|NCT00556972|EG000|Reported Event|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
10898446|NCT00556998|BG000|Baseline|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
10898447|NCT00556998|FG000|Participant Flow|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
10898448|NCT00556998|OG000|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
10898449|NCT00556998|OG000|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
10898450|NCT00556998|OG000|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
10898451|NCT00556998|OG000|Outcome|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2-7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
10898452|NCT00556998|EG000|Reported Event|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
10898453|NCT00556998|EG001|Reported Event|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
10898454|NCT00557076|BG000|Baseline|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
10898455|NCT00557076|BG001|Baseline|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
10898456|NCT00557076|BG002|Baseline|Total|Total of all reporting groups
10898457|NCT00557076|FG000|Participant Flow|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
10898458|NCT00557076|FG001|Participant Flow|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
10915188|NCT00634283|OG000|Outcome|Antidepressant Treatment-experienced|Subjects in this group had prior exposures to antidepressant medication (venlafaxine)
10915189|NCT00634283|OG001|Outcome|Antidepressant Treatment-naive|Subjects in this group had never before been exposed to antidepressant medication
10898459|NCT00557076|OG000|Outcome|FAST|"familiar voice stimulation~FAST is a standardized passive auditory stimulation protocol described elsewhere.8 In brief, the patient is provided with customized recordings of stories told by people well known to the patient at least 1 year prior to injury. The stories represent specific events experienced by both the patient and the storyteller."
10898460|NCT00557076|OG001|Outcome|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
10898461|NCT00557076|EG000|Reported Event|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
10898462|NCT00557076|EG001|Reported Event|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
10898463|NCT00557245|BG000|Baseline|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
10898464|NCT00557245|BG001|Baseline|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
10898465|NCT00557245|BG002|Baseline|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
10898466|NCT00557245|BG003|Baseline|Total|Total of all reporting groups
10898467|NCT00557245|FG000|Participant Flow|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
10898468|NCT00557245|FG001|Participant Flow|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
10898469|NCT00557245|FG002|Participant Flow|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
10898470|NCT00557245|OG000|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
10898471|NCT00557245|OG001|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
10898472|NCT00557245|OG002|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
10898473|NCT00557245|OG000|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
10898474|NCT00557245|OG001|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
10898475|NCT00557245|OG002|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
10898476|NCT00557245|EG000|Reported Event|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
10898477|NCT00557245|EG001|Reported Event|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
10898478|NCT00557245|EG002|Reported Event|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
10898479|NCT00557284|BG000|Baseline|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
10898480|NCT00557284|BG001|Baseline|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
10898481|NCT00557284|BG002|Baseline|Total|Total of all reporting groups
10898482|NCT00557284|FG000|Participant Flow|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
10898483|NCT00557284|FG001|Participant Flow|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
10898484|NCT00557284|OG000|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
10898485|NCT00557284|OG001|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
10898486|NCT00557284|EG000|Reported Event|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
10898487|NCT00557284|EG001|Reported Event|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
10898488|NCT00557310|BG000|Baseline|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
10898489|NCT00557310|FG000|Participant Flow|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
10898490|NCT00557310|OG000|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
10898491|NCT00557310|EG000|Reported Event|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
10898492|NCT00557323|BG000|Baseline|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
10898493|NCT00557323|FG000|Participant Flow|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
10898494|NCT00557323|OG000|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
10898495|NCT00557323|EG000|Reported Event|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
10898496|NCT00557349|BG000|Baseline|Omeprazole|40 mg daily for 14 weeks
10898497|NCT00557349|BG001|Baseline|Famotidine|40 mg daily for 14 weeks
10898498|NCT00557349|BG002|Baseline|Total|Total of all reporting groups
10898499|NCT00557349|FG000|Participant Flow|Omeprazole|40 mg daily at bedtime for 14 weeks
10898500|NCT00557349|FG001|Participant Flow|Famotidine|40 mg daily at bedtime for 14 weeks
10898501|NCT00557349|OG000|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
10898502|NCT00557349|OG001|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
10898503|NCT00557349|EG000|Reported Event|Omeprazole|40 mg daily for 14 weeks
10898504|NCT00557349|EG001|Reported Event|Famotidine|40 mg daily for 14 weeks
10898505|NCT00557362|BG000|Baseline|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
10898506|NCT00557362|BG001|Baseline|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
10898507|NCT00557362|BG002|Baseline|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
10898508|NCT00557362|BG003|Baseline|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
10898509|NCT00557362|BG004|Baseline|Total|Total of all reporting groups
10898510|NCT00557362|FG000|Participant Flow|Topical Natamycin With Corneal De-epithelialization|"Topical natamycin with corneal de-epithelialization.~Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
10898511|NCT00557362|FG001|Participant Flow|Topical Natamycin Without Corneal De-epithelialization|"Topical natamycin without corneal de-epithelialization.~Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
10898512|NCT00557362|FG002|Participant Flow|Topical Voriconazole With Corneal De-epithelialization|"Topical voriconazole with corneal de-epithelialization.~Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
10898513|NCT00557362|FG003|Participant Flow|Topical Voriconazole Without Corneal De-epithelialization|"Topical voriconazole without corneal de-epithelialization.~Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
10898514|NCT00557362|OG000|Outcome|Topical Voriconazole|"Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
10898515|NCT00557362|OG001|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
10898516|NCT00557362|OG000|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
10898517|NCT00557362|OG001|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
10898518|NCT00557362|OG000|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Note that 9 patients in the voriconazole arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
10915190|NCT00634283|EG000|Reported Event|Antidepressant Treatment-experienced|Healthy subjects who have been previously exposed to venlafaxine
10898519|NCT00557362|OG001|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Note that 5 patients in the natamycin arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
10898520|NCT00557362|OG000|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
10898521|NCT00557362|EG000|Reported Event|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
10898522|NCT00557362|EG001|Reported Event|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
10898523|NCT00557362|EG002|Reported Event|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
10898524|NCT00557362|EG003|Reported Event|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
10898525|NCT00557440|BG000|Baseline|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
10898526|NCT00557440|BG001|Baseline|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
10898527|NCT00557440|BG002|Baseline|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
10898528|NCT00557440|BG003|Baseline|Total|Total of all reporting groups
10898529|NCT00557440|FG000|Participant Flow|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
10898530|NCT00557440|FG001|Participant Flow|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
11090679|NCT01530399|OG003|Outcome|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
10898531|NCT00557440|FG002|Participant Flow|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
10898532|NCT00557440|OG000|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
10898533|NCT00557440|OG001|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
10898534|NCT00557440|OG002|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
10898535|NCT00557440|EG000|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
10898536|NCT00557440|EG001|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
10898537|NCT00557440|EG002|Reported Event|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
10898538|NCT00557466|BG000|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898539|NCT00557466|BG001|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898540|NCT00557466|BG002|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898541|NCT00557466|BG003|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898542|NCT00557466|BG004|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
10898543|NCT00557466|BG005|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898544|NCT00557466|BG006|Baseline|Total|Total of all reporting groups
10898545|NCT00557466|FG000|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898546|NCT00557466|FG001|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898547|NCT00557466|FG002|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898548|NCT00557466|FG003|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898549|NCT00557466|FG004|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
10898550|NCT00557466|FG005|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898551|NCT00557466|OG000|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898552|NCT00557466|OG001|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898553|NCT00557466|OG002|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898554|NCT00557466|OG003|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898555|NCT00557466|OG004|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
10898556|NCT00557466|OG005|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898557|NCT00557466|EG000|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898558|NCT00557466|EG001|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898559|NCT00557466|EG002|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898560|NCT00557466|EG003|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898561|NCT00557466|EG004|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
10898562|NCT00557466|EG005|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
10898563|NCT00557492|BG000|Baseline|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
10898564|NCT00557492|FG000|Participant Flow|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
10898565|NCT00557492|OG000|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
10898566|NCT00557492|EG000|Reported Event|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
10898567|NCT00557505|BG000|Baseline|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898568|NCT00557505|BG001|Baseline|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898569|NCT00557505|BG002|Baseline|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898570|NCT00557505|BG003|Baseline|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898571|NCT00557505|BG004|Baseline|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898572|NCT00557505|BG005|Baseline|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898573|NCT00557505|BG006|Baseline|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898574|NCT00557505|BG007|Baseline|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898575|NCT00557505|BG008|Baseline|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898576|NCT00557505|BG009|Baseline|Total|Total of all reporting groups
10898577|NCT00557505|FG000|Participant Flow|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 milligram per kilogram (mg/kg) intravenously (IV) administered over 1 hour (hr) on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898578|NCT00557505|FG001|Participant Flow|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898579|NCT00557505|FG002|Participant Flow|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898580|NCT00557505|FG003|Participant Flow|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898581|NCT00557505|FG004|Participant Flow|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898582|NCT00557505|FG005|Participant Flow|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898583|NCT00557505|FG006|Participant Flow|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898584|NCT00557505|FG007|Participant Flow|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898585|NCT00557505|FG008|Participant Flow|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898586|NCT00557505|OG000|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898587|NCT00557505|OG001|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898588|NCT00557505|OG002|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898589|NCT00557505|OG003|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898590|NCT00557505|OG004|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898591|NCT00557505|OG005|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898592|NCT00557505|OG006|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898593|NCT00557505|OG007|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898594|NCT00557505|OG008|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898595|NCT00557505|OG000|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898596|NCT00557505|OG001|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898597|NCT00557505|OG002|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898598|NCT00557505|EG000|Reported Event|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898599|NCT00557505|EG001|Reported Event|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898600|NCT00557505|EG002|Reported Event|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898601|NCT00557505|EG003|Reported Event|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898602|NCT00557505|EG004|Reported Event|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898603|NCT00557505|EG005|Reported Event|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
10898604|NCT00557505|EG006|Reported Event|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898605|NCT00557505|EG007|Reported Event|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898606|NCT00557505|EG008|Reported Event|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
10898607|NCT00557622|BG000|Baseline|Placebo|Placebo once daily (OD)
10898608|NCT00557622|BG001|Baseline|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
10898609|NCT00557622|BG002|Baseline|Total|Total of all reporting groups
10898610|NCT00557622|FG000|Participant Flow|Placebo|Placebo once daily (OD)
10898611|NCT00557622|FG001|Participant Flow|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
10898612|NCT00557622|OG000|Outcome|Placebo|Placebo once daily (OD)
10898613|NCT00557622|OG001|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
10898614|NCT00557622|EG000|Reported Event|Placebo|Placebo once daily (OD)
10898615|NCT00557622|EG001|Reported Event|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
10898616|NCT00557830|BG000|Baseline|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
10898617|NCT00557830|BG001|Baseline|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
10915191|NCT00634283|EG001|Reported Event|Antidepressant Treatment-naive|Healthy subjects who have never been previously exposed to antidepressant medication
11233299|NCT02426086|FG000|Participant Flow|Imetelstat 4.7 mg/kg|Participants received imetelstat 4.7 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end. After the first interim analysis, treatment for all participants was unblinded and participants assigned to the imetelstat 4.7 mg/kg arm could continue with their same imetelstat dose or have it increased to 9.4 mg/kg at the investigator's discretion. After the end of main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
11233300|NCT02426086|FG001|Participant Flow|Imetelstat 9.4 mg/kg|Participants received imetelstat 9.4 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end. After the end of the main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
11233301|NCT02426086|OG000|Outcome|Imetelstat 4.7 mg/kg|Participants received imetelstat 4.7 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end. After the first interim analysis, treatment for all participants was unblinded and participants assigned to the imetelstat 4.7 mg/kg arm could continue with their same imetelstat dose or have it increased to 9.4 mg/kg at the investigator's discretion. After the end of main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
11233302|NCT02426086|OG001|Outcome|Imetelstat 9.4 mg/kg|Participants received imetelstat 9.4 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end. After the end of the main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
11233303|NCT02426086|OG000|Outcome|Imetelstat 4.7 mg/kg|Participants received imetelstat 4.7 mg/kg of body weight as intravenous infusion on Day 1 of each cycle (each cycle was of 21 days) until disease progression, unacceptable toxicity, or study end. Participants had an option to continue the treatment at the current dose or escalated dose of 9.4 mg/kg based on investigator's discretion. After the end of main study, Participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
11233304|NCT02426086|OG001|Outcome|Imetelstat 9.4 mg/kg|Participants received imetelstat 9.4 mg/kg of body weight as intravenous infusion on Day 1 of each cycle (each cycle was of 21 days) until disease progression, unacceptable toxicity, or study end. After the end of the main study, Participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
11233305|NCT02426086|OG000|Outcome|PK: Imetelstat 4.7 mg/kg|Participants received imetelstat 4.7 mg/kg of body weight as intravenous infusion on Day 1 of cycle 1 and those who had serial PK samples collected.
11233306|NCT02426086|OG001|Outcome|PK: Imetelstat 9.4 mg/kg|Participants received imetelstat 9.4 mg/kg of body weight as intravenous infusion on Day 1 of cycle 1 and those who had serial PK samples collected.
11233307|NCT02426086|EG000|Reported Event|Imetelstat 4.7 mg/kg|Participants received imetelstat 4.7 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end. After the first interim analysis, treatment for all participants was unblinded and participants assigned to the imetelstat 4.7 mg/kg arm could continue with their same imetelstat dose. After the end of main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years). AEs for the 12 subjects whose dose was later escalated are included here for the period before dose escalation.
11233308|NCT02426086|EG001|Reported Event|Imetelstat 9.4 mg/kg|Participants received imetelstat 9.4 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end. After the end of the main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years).
10915192|NCT00634543|BG000|Baseline|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
11233309|NCT02426086|EG002|Reported Event|Imetelstat Dose Escalated From 4.7 mg/kg to 9.4 mg/kg|Participants initially treated with 4.7 mg/kg imetelstat in Imetelstat 4.7 mg/kg arm group were subsequently dose escalated to 9.4 mg/kg at the investigator's discretion. Dose escalation for these participants may occur at any cycle (each of 21-day cycle) of the treatment phase. After the end of main study, participants who were receiving benefit from study treatment opted to continue to receive imetelstat during the Extension Phase until there is loss of benefit or unacceptable toxicity. (Maximum duration on study was approximately 2.3 years and Maximum duration on extension phase was approximately 1.8 years). AEs reported in this column occurred after dose escalation.
10898618|NCT00557830|BG002|Baseline|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
10898619|NCT00557830|BG003|Baseline|Total|Total of all reporting groups
10898620|NCT00557830|FG000|Participant Flow|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
10898621|NCT00557830|FG001|Participant Flow|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
10898622|NCT00557830|FG002|Participant Flow|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
10898623|NCT00557830|OG000|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
10898624|NCT00557830|OG001|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
10898625|NCT00557830|OG002|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
10898626|NCT00557830|EG000|Reported Event|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
10898627|NCT00557830|EG001|Reported Event|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
10898628|NCT00557830|EG002|Reported Event|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
11090680|NCT01530399|OG004|Outcome|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
11090681|NCT01530399|OG005|Outcome|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
11090682|NCT01530399|EG000|Reported Event|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
11090683|NCT01530399|EG001|Reported Event|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
11090684|NCT01530399|EG002|Reported Event|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
11090685|NCT01530399|EG003|Reported Event|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
11090686|NCT01530399|EG004|Reported Event|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
11090687|NCT01530399|EG005|Reported Event|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
11090688|NCT01530464|BG000|Baseline|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
11090689|NCT01530464|BG001|Baseline|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
11090690|NCT01530464|BG002|Baseline|Total|Total of all reporting groups
11090691|NCT01530464|FG000|Participant Flow|Sequence A|Period 1: First intervention (Aminophylline 500mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Ambrisentan 5mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
11090692|NCT01530464|FG001|Participant Flow|Sequence B|Period 1: First intervention (Ambrisentan 5mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Aminophylline 500mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
11090693|NCT01530464|OG000|Outcome|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
11090694|NCT01530464|OG001|Outcome|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
11090695|NCT01530464|OG000|Outcome|Aminophylline Alone|
11090696|NCT01530464|OG001|Outcome|Aminophylline in Presence of Ambrisentan|
11090697|NCT01530464|OG002|Outcome|Ambrisentan Alone|
11090698|NCT01530464|OG003|Outcome|Ambrisentan in Presence of Aminophylline|
11090699|NCT01530464|EG000|Reported Event|Aminophylline Only|Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
11090700|NCT01530464|EG001|Reported Event|Ambrisentan Only|Ambrisentan 5 mg orally, followed by 48 h washout period. lowed by 48 h washout period.
11090701|NCT01530464|EG002|Reported Event|Combined Aminophylline and Ambrisentan|Combined single doses of Aminophylline 400 mg and ambrisentan 5 mg, followed by a 48 h washout period
11090702|NCT01530477|BG000|Baseline|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
11233310|NCT02426138|BG000|Baseline|Meal Delivery Then Usual Care + Choose myPlate|"During the first intervention period, participants in this arm will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the first intervention period will comprise the 'on-meal' data for this participants in this arm.~Following this, during the second intervention period, they will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the second intervention period will comprise the 'off-meal' data for participants in this arm."
11090703|NCT01530477|BG001|Baseline|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
11090704|NCT01530477|BG002|Baseline|Skeletal and Body Composition|"Skeletal and Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
11090705|NCT01530477|BG003|Baseline|Total|Total of all reporting groups
10898629|NCT00557856|BG000|Baseline|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
10898630|NCT00557856|FG000|Participant Flow|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898631|NCT00557856|FG001|Participant Flow|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898632|NCT00557856|FG002|Participant Flow|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898633|NCT00557856|FG003|Participant Flow|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898634|NCT00557856|FG004|Participant Flow|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898635|NCT00557856|FG005|Participant Flow|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898636|NCT00557856|FG006|Participant Flow|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898637|NCT00557856|FG007|Participant Flow|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898638|NCT00557856|FG008|Participant Flow|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898639|NCT00557856|OG000|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
10898640|NCT00557856|OG000|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898641|NCT00557856|OG001|Outcome|PF-03446962 1 mg/kg|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898642|NCT00557856|OG002|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898643|NCT00557856|OG003|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898644|NCT00557856|OG004|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898645|NCT00557856|OG005|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898646|NCT00557856|OG006|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898647|NCT00557856|OG007|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898648|NCT00557856|OG008|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898649|NCT00557856|OG001|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
11357157|NCT03764449|OG002|Outcome|Cohort 2, Period 1|Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10898650|NCT00557856|OG000|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
10898651|NCT00557856|EG000|Reported Event|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
10898652|NCT00557882|BG000|Baseline|Mesh|"Vaginal reconstructive surgery with synthetic polypropylene mesh~synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine."
10898653|NCT00557882|BG001|Baseline|no Mesh|"Vaginal reconstructive surgery without mesh~synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine."
10898654|NCT00557882|BG002|Baseline|Total|Total of all reporting groups
10898655|NCT00557882|FG000|Participant Flow|Mesh|"Vaginal reconstructive surgery with synthetic polypropylene mesh~synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine."
10898656|NCT00557882|FG001|Participant Flow|no Mesh|"Vaginal reconstructive surgery without mesh~synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine."
10898657|NCT00557882|OG000|Outcome|Mesh|"Vaginal reconstructive surgery with synthetic polypropylene mesh~synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine."
10898658|NCT00557882|OG001|Outcome|no Mesh|"Vaginal reconstructive surgery without mesh~synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine."
10898659|NCT00557882|EG000|Reported Event|Mesh|"Vaginal reconstructive surgery with synthetic polypropylene mesh~synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine."
10898660|NCT00557882|EG001|Reported Event|no Mesh|"Vaginal reconstructive surgery without mesh~synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine."
10898661|NCT00557947|BG000|Baseline|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
10898662|NCT00557947|FG000|Participant Flow|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
10898663|NCT00557947|OG000|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
10898664|NCT00557947|OG001|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
10898665|NCT00557947|EG000|Reported Event|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
10898666|NCT00557947|EG001|Reported Event|Suture|Suture - Incision segments are randomized & patient is own control.
10898667|NCT00557947|EG002|Reported Event|Procedure|
10898668|NCT00557947|EG003|Reported Event|Unrelated|Reported events per local regulatory requirements but not related to either device or procedure.
10898669|NCT00558012|BG000|Baseline|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
10898670|NCT00558012|BG001|Baseline|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
11342230|NCT03701061|EG001|Reported Event|Participants That Did Not Receive AS03 Adjuvant|"Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).~Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study"
10898671|NCT00558012|BG002|Baseline|Total|Total of all reporting groups
10898672|NCT00558012|FG000|Participant Flow|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
10898673|NCT00558012|FG001|Participant Flow|Placebo|"Placebo~One-time dose: Intravenous saline"
10898674|NCT00558012|OG000|Outcome|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
10898675|NCT00558012|OG001|Outcome|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
10898676|NCT00558012|EG000|Reported Event|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
10898677|NCT00558012|EG001|Reported Event|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
10898678|NCT00558025|BG000|Baseline|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
10898679|NCT00558025|BG001|Baseline|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
10898680|NCT00558025|BG002|Baseline|Total|Total of all reporting groups
10898681|NCT00558025|FG000|Participant Flow|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d. (Quaque die, once per day), per os
10898682|NCT00558025|FG001|Participant Flow|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
10898683|NCT00558025|OG000|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
10898684|NCT00558025|OG001|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
10898685|NCT00558025|EG000|Reported Event|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
10898686|NCT00558025|EG001|Reported Event|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
10898687|NCT00558064|BG000|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
10898688|NCT00558064|BG001|Baseline|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
10898689|NCT00558064|BG002|Baseline|Total|Total of all reporting groups
10898690|NCT00558064|FG000|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
10898691|NCT00558064|FG001|Participant Flow|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
10898692|NCT00558064|OG000|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
10898693|NCT00558064|OG001|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
10898694|NCT00558064|EG000|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
10898695|NCT00558064|EG001|Reported Event|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
10898696|NCT00558103|BG000|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
10898697|NCT00558103|BG001|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
10898698|NCT00558103|BG002|Baseline|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
10898699|NCT00558103|BG003|Baseline|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
10898700|NCT00558103|BG004|Baseline|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
10898701|NCT00558103|BG005|Baseline|Total|Total of all reporting groups
10898702|NCT00558103|FG000|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
10898703|NCT00558103|FG001|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
10898704|NCT00558103|FG002|Participant Flow|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
10898705|NCT00558103|FG003|Participant Flow|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
10898706|NCT00558103|FG004|Participant Flow|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
10898707|NCT00558103|FG005|Participant Flow|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
10898708|NCT00558103|OG000|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
10898709|NCT00558103|OG001|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
10898710|NCT00558103|OG002|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
10898711|NCT00558103|OG003|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
10898712|NCT00558103|OG004|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
10898713|NCT00558103|EG000|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
10898714|NCT00558103|EG001|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
10898715|NCT00558103|EG002|Reported Event|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
10898716|NCT00558103|EG003|Reported Event|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
10898717|NCT00558103|EG004|Reported Event|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
10898718|NCT00558103|EG005|Reported Event|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
10898719|NCT00558246|BG000|Baseline|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
10898720|NCT00558246|FG000|Participant Flow|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
10898721|NCT00558246|OG000|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
10898722|NCT00558246|OG001|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
10898723|NCT00558246|EG000|Reported Event|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
10898724|NCT00558246|EG001|Reported Event|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
10898725|NCT00558246|EG002|Reported Event|Procedure|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
10898726|NCT00558259|BG000|Baseline|Dabigatran|Dabigatran 150mg bid
10898727|NCT00558259|BG001|Baseline|Placebo|Matching placebo
10898728|NCT00558259|BG002|Baseline|Total|Total of all reporting groups
10898729|NCT00558259|FG000|Participant Flow|Dabigatran|Dabigatran 150mg bid (twice daily)
10898730|NCT00558259|FG001|Participant Flow|Placebo|Matching placebo
10898731|NCT00558259|OG000|Outcome|Dabigatran|Dabigatran 150mg bid
10898732|NCT00558259|OG001|Outcome|Placebo|Matching placebo
11335633|NCT03554018|BG000|Baseline|Acetaminophen|"Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.~Acetaminophen: Acetaminophen 500-1000mg every 6 hours~Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10898733|NCT00558259|EG000|Reported Event|Dabigatran|Dabigatran 150mg bid
10898734|NCT00558259|EG001|Reported Event|Placebo|Matching placebo
10898735|NCT00558272|BG000|Baseline|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
10898736|NCT00558272|BG001|Baseline|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
10898737|NCT00558272|BG002|Baseline|Total|Total of all reporting groups
10898738|NCT00558272|FG000|Participant Flow|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
10898739|NCT00558272|FG001|Participant Flow|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
10898740|NCT00558272|OG000|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
10898741|NCT00558272|OG001|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
10898742|NCT00558272|EG000|Reported Event|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
10898743|NCT00558272|EG001|Reported Event|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
10898744|NCT00558285|BG000|Baseline|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898745|NCT00558285|BG001|Baseline|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898746|NCT00558285|BG002|Baseline|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898747|NCT00558285|BG003|Baseline|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898748|NCT00558285|BG004|Baseline|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898749|NCT00558285|BG005|Baseline|Total|Total of all reporting groups
10898750|NCT00558285|FG000|Participant Flow|Indacaterol/Glycopyrrolate 600 μg/100 μg|"Two capsules indacaterol/glycopyrrolate 300 μg/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898751|NCT00558285|FG001|Participant Flow|Indacaterol/Glycopyrrolate 300 μg/100 μg|"One capsule indacaterol/glycopyrrolate 300 μg/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898752|NCT00558285|FG002|Participant Flow|Indacaterol/Glycopyrrolate 150 μg/100 μg|"One capsule indacaterol/glycopyrrolate 150 μg/50 μg and one capsule 50μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898753|NCT00558285|FG003|Participant Flow|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898754|NCT00558285|FG004|Participant Flow|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898755|NCT00558285|OG000|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898756|NCT00558285|OG001|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898757|NCT00558285|OG002|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898758|NCT00558285|OG003|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898759|NCT00558285|OG004|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898760|NCT00558285|EG000|Reported Event|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898761|NCT00558285|EG001|Reported Event|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898762|NCT00558285|EG002|Reported Event|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898763|NCT00558285|EG003|Reported Event|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
10898764|NCT00558285|EG004|Reported Event|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol /albuterol as rescue medication was permitted throughout the study."
10898765|NCT00558363|BG000|Baseline|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
10898766|NCT00558363|BG001|Baseline|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
10898767|NCT00558363|BG002|Baseline|Total|Total of all reporting groups
11342268|NCT03703336|FG001|Participant Flow|ROTAVIN-M1 Frozen Formulation|Participants received two doses of ROTAVIN-M1 frozen formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
10898768|NCT00558363|FG000|Participant Flow|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
11342269|NCT03703336|OG000|Outcome|ROTAVIN Liquid Formulation|Participants received two doses of ROTAVIN liquid formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
10898769|NCT00558363|FG001|Participant Flow|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
10898770|NCT00558363|OG000|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
10898771|NCT00558363|OG001|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
10898772|NCT00558363|EG000|Reported Event|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
10898773|NCT00558363|EG001|Reported Event|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
10898774|NCT00558428|BG000|Baseline|Amlodipine 5mg|
10898775|NCT00558428|BG001|Baseline|Amlodipine 10mg|
10898776|NCT00558428|BG002|Baseline|Telmisartan 40mg and Amlodipine 5mg|
10898777|NCT00558428|BG003|Baseline|Telmisartan 80mg and Amlodipine 5mg|
10898778|NCT00558428|BG004|Baseline|Total|Total of all reporting groups
10898779|NCT00558428|FG000|Participant Flow|Amlodipine 5mg|
10898780|NCT00558428|FG001|Participant Flow|Amlodipine 10mg|
10898781|NCT00558428|FG002|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
10898782|NCT00558428|FG003|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
10898783|NCT00558428|OG000|Outcome|Amlodipine 5mg|
10898784|NCT00558428|OG001|Outcome|Amlodipine 10mg|
10898785|NCT00558428|OG002|Outcome|Telmisartan 40mg and Amlodipine 5mg|
10898786|NCT00558428|OG003|Outcome|Telmisartan 80mg and Amlodipine 5mg|
10898787|NCT00558428|EG000|Reported Event|Amlodipine 5mg|
10898788|NCT00558428|EG001|Reported Event|Amlodipine 10mg|
10898789|NCT00558428|EG002|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
10898790|NCT00558428|EG003|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
10898791|NCT00558467|BG000|Baseline|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
10898792|NCT00558467|BG001|Baseline|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
10898793|NCT00558467|BG002|Baseline|Total|Total of all reporting groups
10898794|NCT00558467|FG000|Participant Flow|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
10898795|NCT00558467|FG001|Participant Flow|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
10898796|NCT00558467|OG000|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
10898797|NCT00558467|OG001|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
10898798|NCT00558467|EG000|Reported Event|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
10898799|NCT00558467|EG001|Reported Event|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
10898800|NCT00558519|BG000|Baseline|Treatment (Pediatric Regimen)|"Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the Detailed Description section for more information."
10898801|NCT00558519|FG000|Participant Flow|Treatment (Pediatric Regimen)|"Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the Detailed Description section for more information."
11342270|NCT03703336|OG001|Outcome|ROTAVIN-M1 Frozen Formulation|Participants received two doses of ROTAVIN-M1 frozen formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
10898802|NCT00558519|OG000|Outcome|Treatment (Pediatric Regimen)|"Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the Detailed Description section for more information."
10898803|NCT00558519|EG000|Reported Event|Treatment (Pediatric Regimen)|"Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the Detailed Description section for more information."
10898804|NCT00558571|BG000|Baseline|Placebo|oral administration in the fasted state once daily.
10898805|NCT00558571|BG001|Baseline|10mg Empagliflozin|oral administration in the fasted state once daily.
10898806|NCT00558571|BG002|Baseline|25mg Empagliflozin|oral administration in the fasted state once daily.
10898807|NCT00558571|BG003|Baseline|100mg Empagliflozin|oral administration in the fasted state once daily.
10898808|NCT00558571|BG004|Baseline|Total|Total of all reporting groups
10898809|NCT00558571|FG000|Participant Flow|Placebo|Oral administration in the fasted state once daily
10898810|NCT00558571|FG001|Participant Flow|10mg Empagliflozin|Oral administration in the fasted state once daily.
10898811|NCT00558571|FG002|Participant Flow|25mg Empagliflozin|Oral administration in the fasted state once daily.
10898812|NCT00558571|FG003|Participant Flow|100mg Empagliflozin|Oral administration in the fasted state once daily.
11342271|NCT03703336|EG000|Reported Event|ROTAVIN Liquid Formulation|Participants received two doses of ROTAVIN liquid formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
10898813|NCT00558571|OG000|Outcome|Placebo|oral administration in the fasted state once daily.
10898814|NCT00558571|OG001|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
10898815|NCT00558571|OG002|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
10898816|NCT00558571|OG003|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
10898817|NCT00558571|OG000|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
10898818|NCT00558571|OG001|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
10898819|NCT00558571|OG002|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
10898820|NCT00558571|OG000|Outcome|Placebo|Oral administration in the fasted state once daily.
10898821|NCT00558571|OG001|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
10898822|NCT00558571|OG002|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
10898823|NCT00558571|OG003|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
10898824|NCT00558571|OG000|Outcome|Placebo|Oral administration in the fasted state once daily
10898825|NCT00558571|OG001|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily
10898826|NCT00558571|OG002|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily
10898827|NCT00558571|OG003|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily
10898828|NCT00558571|EG000|Reported Event|Placebo|oral administration in the fasted state once daily
10898829|NCT00558571|EG001|Reported Event|10mg Empagliflozin|oral administration in the fasted state once daily
10898830|NCT00558571|EG002|Reported Event|25mg Empagliflozin|oral administration in the fasted state once daily
10898831|NCT00558571|EG003|Reported Event|100mg Empagliflozin|oral administration in the fasted state once daily
10898832|NCT00558636|BG000|Baseline|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
10898833|NCT00558636|BG001|Baseline|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
10898834|NCT00558636|BG002|Baseline|Total|Total of all reporting groups
10898835|NCT00558636|FG000|Participant Flow|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
10898836|NCT00558636|FG001|Participant Flow|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
10898837|NCT00558636|OG000|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
10898838|NCT00558636|OG001|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
10898839|NCT00558636|EG000|Reported Event|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
10898840|NCT00558636|EG001|Reported Event|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
10898841|NCT00558701|BG000|Baseline|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing.~Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
10898842|NCT00558701|BG001|Baseline|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
10898843|NCT00558701|BG002|Baseline|Total|Total of all reporting groups
10898844|NCT00558701|FG000|Participant Flow|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
10898845|NCT00558701|FG001|Participant Flow|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
10898846|NCT00558701|OG000|Outcome|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
10898847|NCT00558701|OG001|Outcome|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
10898848|NCT00558701|EG000|Reported Event|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
10898849|NCT00558701|EG001|Reported Event|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
10898850|NCT00558753|BG000|Baseline|1 Placebo|Half of the patients will receive PO placebo for 14 days
10898851|NCT00558753|BG001|Baseline|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
10898852|NCT00558753|BG002|Baseline|Total|Total of all reporting groups
10898853|NCT00558753|FG000|Participant Flow|1 Placebo|Half of the patients will receive oral (PO) placebo for 14 days
10898854|NCT00558753|FG001|Participant Flow|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
10898855|NCT00558753|OG000|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
10898856|NCT00558753|OG001|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
10898857|NCT00558753|EG000|Reported Event|1 Placebo|Half of the patients will receive PO placebo for 14 days
10898858|NCT00558753|EG001|Reported Event|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
10898859|NCT00558792|BG000|Baseline|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
10898860|NCT00558792|BG001|Baseline|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
10898861|NCT00558792|BG002|Baseline|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
10898862|NCT00558792|BG003|Baseline|Total|Total of all reporting groups
10898863|NCT00558792|FG000|Participant Flow|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
10898864|NCT00558792|FG001|Participant Flow|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
10898865|NCT00558792|FG002|Participant Flow|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
10898866|NCT00558792|OG000|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
10898867|NCT00558792|OG001|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
10898868|NCT00558792|OG002|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
10898869|NCT00558792|OG000|Outcome|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
10898870|NCT00558792|OG001|Outcome|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
10898871|NCT00558792|OG002|Outcome|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
10898872|NCT00558792|EG000|Reported Event|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
10898873|NCT00558792|EG001|Reported Event|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
10898874|NCT00558792|EG002|Reported Event|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
10898875|NCT00558831|BG000|Baseline|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
10898876|NCT00558831|FG000|Participant Flow|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
10898877|NCT00558831|OG000|Outcome|Benzoyl Peroxide 2.5% Cream|
10898878|NCT00558831|OG001|Outcome|Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion|
10898879|NCT00558831|EG000|Reported Event|Benzoyl Peroxide 2.5%|
10898880|NCT00558831|EG001|Reported Event|Benzoyl Peroxide 2.5% Plus Moisturizing Lotion|
10898881|NCT00558844|BG000|Baseline|Arikayce™ at 560 mg|Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo.
10898882|NCT00558844|BG001|Baseline|Placebo at 560 mg|Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo.
10898883|NCT00558844|BG002|Baseline|Arikayce™ at 70 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898884|NCT00558844|BG003|Baseline|Arikayce™ at 140 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898885|NCT00558844|BG004|Baseline|Placebo at 70 mg/140 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898886|NCT00558844|BG005|Baseline|Total|Total of all reporting groups
10898887|NCT00558844|FG000|Participant Flow|Arikayce™ at 560 mg|Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo.
10898888|NCT00558844|FG001|Participant Flow|Placebo at 560 mg|"Matching placebo~Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo."
10898889|NCT00558844|FG002|Participant Flow|Arikayce™ at 70 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898890|NCT00558844|FG003|Participant Flow|Arikayce™ at 140 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898891|NCT00558844|FG004|Participant Flow|Placebo at 70mg/140 mg|"Matching placebo~Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo."
10898892|NCT00558844|OG000|Outcome|Arikayce™ at 560 mg|Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo.
10898893|NCT00558844|OG001|Outcome|Placebo at 560 mg|"Matching placebo~Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo."
10898894|NCT00558844|OG002|Outcome|Arikayce™ at 70 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898895|NCT00558844|OG003|Outcome|Arikayce™ at 140 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898896|NCT00558844|OG004|Outcome|Placebo at 70mg/140 mg|"Matching placebo~Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo."
10898897|NCT00558844|OG003|Outcome|Arikayce ™at 140 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898898|NCT00558844|EG000|Reported Event|Arikayce™ at 560 mg|Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo.
10898899|NCT00558844|EG001|Reported Event|Placebo at 560 mg|"Matching placebo~Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo."
10898900|NCT00558844|EG002|Reported Event|Arikayce™ at 70 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898901|NCT00558844|EG003|Reported Event|Arikayce™ at 140 mg|Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo.
10898902|NCT00558844|EG004|Reported Event|Placebo at 70 mg/140 mg|"Matching placebo~Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo."
10898903|NCT00558896|BG000|Baseline|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898904|NCT00558896|BG001|Baseline|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898905|NCT00558896|BG002|Baseline|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898906|NCT00558896|BG003|Baseline|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898907|NCT00558896|BG004|Baseline|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898908|NCT00558896|BG005|Baseline|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
11090706|NCT01530477|FG000|Participant Flow|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
11090707|NCT01530477|FG001|Participant Flow|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
11090708|NCT01530477|FG002|Participant Flow|Skeletal & Body Composition|"Skeletal & Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
11090709|NCT01530477|OG000|Outcome|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
11090710|NCT01530477|OG001|Outcome|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
11090711|NCT01530477|EG000|Reported Event|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
11090712|NCT01530477|EG001|Reported Event|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
11090713|NCT01531153|BG000|Baseline|Placebo|"Sugar Pill will be compared with the active medication Galantamine~Placebo: Placebo dose."
11090714|NCT01531153|BG001|Baseline|Galantamine 8mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 8mg"
11090715|NCT01531153|BG002|Baseline|Galantamine 16mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 16mg"
11090716|NCT01531153|BG003|Baseline|Total|Total of all reporting groups
11090717|NCT01531153|FG000|Participant Flow|Placebo|"Sugar Pill will be compared with the active medication Galantamine~Placebo: Placebo dose."
11090718|NCT01531153|FG001|Participant Flow|Galantamine 8mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 8mg"
11090719|NCT01531153|FG002|Participant Flow|Galantamine 16mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 16mg"
11090720|NCT01531153|OG000|Outcome|Placebo|"Sugar Pill will be compared with the active medication Galantamine~Placebo: Placebo dose."
11090721|NCT01531153|OG001|Outcome|Galantamine 8mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 8mg"
11090722|NCT01531153|OG002|Outcome|Galantamine 16mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 16mg"
10898909|NCT00558896|BG006|Baseline|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898910|NCT00558896|BG007|Baseline|Total|Total of all reporting groups
10898911|NCT00558896|FG000|Participant Flow|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
11090723|NCT01531153|OG000|Outcome|Galantamine 8mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 8mg"
11090724|NCT01531153|OG001|Outcome|Galantamine 16mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 16mg"
10898912|NCT00558896|FG001|Participant Flow|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898913|NCT00558896|FG002|Participant Flow|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898914|NCT00558896|FG003|Participant Flow|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898915|NCT00558896|FG004|Participant Flow|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898916|NCT00558896|FG005|Participant Flow|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898917|NCT00558896|FG006|Participant Flow|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898918|NCT00558896|OG000|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898919|NCT00558896|OG001|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898920|NCT00558896|OG002|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898921|NCT00558896|OG003|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898922|NCT00558896|OG004|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898923|NCT00558896|OG005|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898924|NCT00558896|OG006|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898925|NCT00558896|EG000|Reported Event|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898926|NCT00558896|EG001|Reported Event|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898927|NCT00558896|EG002|Reported Event|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898928|NCT00558896|EG003|Reported Event|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898929|NCT00558896|EG004|Reported Event|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898930|NCT00558896|EG005|Reported Event|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898931|NCT00558896|EG006|Reported Event|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
10898932|NCT00559013|BG000|Baseline|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
10898933|NCT00559013|FG000|Participant Flow|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
10898934|NCT00559013|OG000|Outcome|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
10898935|NCT00559013|EG000|Reported Event|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
10898936|NCT00559104|BG000|Baseline|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
10898937|NCT00559104|BG001|Baseline|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
10898938|NCT00559104|BG002|Baseline|Total|Total of all reporting groups
10898939|NCT00559104|FG000|Participant Flow|TBI-based Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
10898940|NCT00559104|FG001|Participant Flow|nonTBI-based Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
10898941|NCT00559104|OG000|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
11090725|NCT01531153|OG002|Outcome|Placebo|"Sugar Pill will be compared with the active medication Galantamine~Placebo: Placebo dose."
10898942|NCT00559104|OG001|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
10898943|NCT00559104|EG000|Reported Event|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
10898944|NCT00559104|EG001|Reported Event|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
10898945|NCT00559273|BG000|Baseline|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
10898946|NCT00559273|BG001|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
10898947|NCT00559273|BG002|Baseline|Total|Total of all reporting groups
10898948|NCT00559273|FG000|Participant Flow|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
10898949|NCT00559273|FG001|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
10898950|NCT00559273|OG000|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
10898951|NCT00559273|OG001|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
11090726|NCT01531153|EG000|Reported Event|Placebo|"Sugar Pill will be compared with the active medication Galantamine~Placebo: Placebo dose."
10898952|NCT00559273|EG000|Reported Event|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
10898953|NCT00559273|EG001|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
10898954|NCT00559364|BG000|Baseline|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
10898955|NCT00559364|BG001|Baseline|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
10898956|NCT00559364|BG002|Baseline|Total|Total of all reporting groups
10898957|NCT00559364|FG000|Participant Flow|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
10898958|NCT00559364|FG001|Participant Flow|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
10898959|NCT00559364|OG000|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
10898960|NCT00559364|OG001|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
10898961|NCT00559364|EG000|Reported Event|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
10898962|NCT00559364|EG001|Reported Event|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
10898963|NCT00559377|BG000|Baseline|All Patients|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later.
10898964|NCT00559377|FG000|Participant Flow|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
11090727|NCT01531153|EG001|Reported Event|Galantamine 8mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 8mg"
11090728|NCT01531153|EG002|Reported Event|Galantamine 16mg|"Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.~Galantamine: 16mg"
10898965|NCT00559377|OG000|Outcome|2 Year Overall Survival|Patients who have not been declared deceased for 2 years after their last FMISO scan.
10898966|NCT00559377|OG000|Outcome|Disease-Free Survival|Patients who have remained disease-free throughout the 2 year follow up
10898967|NCT00559377|OG000|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
10898968|NCT00559377|OG000|Outcome|Patients Who Had Response Determined by Clinical RECIST|
10898969|NCT00559377|EG000|Reported Event|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
10898970|NCT00559468|BG000|Baseline|Sugammadex + Sevoflurane|After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
10898971|NCT00559468|BG001|Baseline|Sugammadex + Propofol|After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
10898972|NCT00559468|BG002|Baseline|Total|Total of all reporting groups
10898973|NCT00559468|FG000|Participant Flow|Sugammadex + Sevoflurane|After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
10898974|NCT00559468|FG001|Participant Flow|Sugammadex + Propofol|After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
10898975|NCT00559468|OG000|Outcome|Sugammadex + Sevoflurane|After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
10898976|NCT00559468|OG001|Outcome|Sugammadex + Propofol|After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
10898977|NCT00559468|EG000|Reported Event|Sugammadex + Sevoflurane|After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
10898978|NCT00559468|EG001|Reported Event|Sugammadex + Propofol|After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
10898979|NCT00559507|BG000|Baseline|Treatment (Saracatinib)|Patients will receive AZD0530 175mg orally daily for 4 weeks.
10898980|NCT00559507|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10898981|NCT00559507|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10898982|NCT00559507|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10898983|NCT00559585|BG000|Baseline|Subcutaneous (SC) Abatacept|Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
10898984|NCT00559585|BG001|Baseline|Intravenous (IV) Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
10898985|NCT00559585|BG002|Baseline|Total|Total of all reporting groups
10898986|NCT00559585|FG000|Participant Flow|Subcutaneous (SC) Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. During the Open Label Long Term (LT) Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
10898987|NCT00559585|FG001|Participant Flow|Intravenous (IV) Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
10898988|NCT00559585|OG000|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
10898989|NCT00559585|OG001|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
11342272|NCT03703336|EG001|Reported Event|ROTAVIN-M1 Frozen Formulation|Participants received two doses of ROTAVIN-M1 frozen formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
10898990|NCT00559585|OG000|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
10898991|NCT00559585|OG001|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (Subcutaneous placebo placebo).
10898992|NCT00559585|OG000|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
10898993|NCT00559585|OG001|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
10898994|NCT00559585|OG000|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception
10898995|NCT00559585|OG000|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
10898996|NCT00559585|OG001|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
10898997|NCT00559585|OG001|Outcome|Intravenous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
10898998|NCT00559585|OG000|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
10898999|NCT00559585|OG000|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
10899000|NCT00559585|OG001|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
10899001|NCT00559585|EG000|Reported Event|IV Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could switch to SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
10899002|NCT00559585|EG001|Reported Event|SC Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could continue SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
10899003|NCT00559637|BG000|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
11090729|NCT01531205|BG000|Baseline|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
10899004|NCT00559637|FG000|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 micrograms per kilogram (mcg/kg) of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
10899005|NCT00559637|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
10899006|NCT00559637|EG000|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
10899007|NCT00559754|BG000|Baseline|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
10899008|NCT00559754|FG000|Participant Flow|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|"Participants received doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.~Participants then received bevacizumab 15 mg per kilogram (mg/kg) IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles."
10899009|NCT00559754|OG000|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
10899010|NCT00559754|EG000|Reported Event|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
11342273|NCT03703817|BG000|Baseline|Tofacitinib Citrate|Participants who had been using tofacitinib citrate for more than 6 months or more and less than 2 years for RA treatment were included in the group.
10899011|NCT00559845|BG000|Baseline|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
10899012|NCT00559845|FG000|Participant Flow|Bevacizumab|"5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 milligrams per meter squared (mg/m^2) intravenous (i.v.) bolus over ≤15 minutes (min); epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles."
10899013|NCT00559845|OG000|Outcome|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
10899014|NCT00559845|EG000|Reported Event|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
10899015|NCT00559949|BG000|Baseline|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
10899016|NCT00559949|FG000|Participant Flow|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
10899017|NCT00559949|OG000|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
10899018|NCT00559949|EG000|Reported Event|All Participants|All participants on study.
10899019|NCT00559962|BG000|Baseline|Placebo|Oral placebo every 4 weeks for 12 weeks
10899020|NCT00559962|BG001|Baseline|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
10899021|NCT00559962|BG002|Baseline|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
10899022|NCT00559962|BG003|Baseline|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
10899023|NCT00559962|BG004|Baseline|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
10899024|NCT00559962|BG005|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
10899025|NCT00559962|BG006|Baseline|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
10899026|NCT00559962|BG007|Baseline|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
10899027|NCT00559962|BG008|Baseline|Total|Total of all reporting groups
10899028|NCT00559962|FG000|Participant Flow|Placebo|Oral placebo every 4 weeks for 12 weeks
10899029|NCT00559962|FG001|Participant Flow|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
10899030|NCT00559962|FG002|Participant Flow|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
10899031|NCT00559962|FG003|Participant Flow|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
10899032|NCT00559962|FG004|Participant Flow|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
10899033|NCT00559962|FG005|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
10899034|NCT00559962|FG006|Participant Flow|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
10899035|NCT00559962|FG007|Participant Flow|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
10899036|NCT00559962|OG000|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
10899037|NCT00559962|OG001|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
10899038|NCT00559962|OG001|Outcome|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
10899039|NCT00559962|OG002|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
10899040|NCT00559962|OG003|Outcome|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
10899041|NCT00559962|OG004|Outcome|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
10899042|NCT00559962|OG005|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
10899043|NCT00559962|OG006|Outcome|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
10899044|NCT00559962|OG007|Outcome|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
10899045|NCT00559962|EG000|Reported Event|Placebo|Oral placebo every 4 weeks for 12 weeks
10899046|NCT00559962|EG001|Reported Event|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
10899047|NCT00559962|EG002|Reported Event|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
10899048|NCT00559962|EG003|Reported Event|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
10899049|NCT00559962|EG004|Reported Event|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
10899050|NCT00559962|EG005|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
10899051|NCT00559962|EG006|Reported Event|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
10899052|NCT00559962|EG007|Reported Event|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
10899053|NCT00559988|BG000|Baseline|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
10899054|NCT00559988|BG001|Baseline|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
10899055|NCT00559988|BG002|Baseline|Total|Total of all reporting groups
10899056|NCT00559988|FG000|Participant Flow|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
10899057|NCT00559988|FG001|Participant Flow|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
10899058|NCT00559988|OG000|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
10899059|NCT00559988|OG001|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
10899060|NCT00559988|EG000|Reported Event|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
10899061|NCT00559988|EG001|Reported Event|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
10899062|NCT00560066|BG000|Baseline|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
10899063|NCT00560066|BG001|Baseline|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
10899064|NCT00560066|BG002|Baseline|Total|Total of all reporting groups
10899065|NCT00560066|FG000|Participant Flow|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.
10899066|NCT00560066|FG001|Participant Flow|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.
10899067|NCT00560066|OG000|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine
10899068|NCT00560066|OG001|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
10899069|NCT00560066|OG002|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
10899070|NCT00560066|OG003|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
10899071|NCT00560066|OG000|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
10899072|NCT00560066|OG000|Outcome|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
10899073|NCT00560066|OG001|Outcome|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
10899074|NCT00560066|EG000|Reported Event|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
10899075|NCT00560066|EG001|Reported Event|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
10899076|NCT00560105|BG000|Baseline|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
10899077|NCT00560105|BG001|Baseline|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
10899078|NCT00560105|BG002|Baseline|Total|Total of all reporting groups
10899079|NCT00560105|FG000|Participant Flow|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
10899080|NCT00560105|FG001|Participant Flow|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
10899081|NCT00560105|OG000|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
10899082|NCT00560105|OG001|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
10899083|NCT00560105|EG000|Reported Event|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
10899084|NCT00560105|EG001|Reported Event|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
11342274|NCT03703817|BG001|Baseline|Adalimumab|Participants who had been using adalimumab for more than 6 months or more and less than 2 years for RA treatment were included in the group.
10899085|NCT00560235|BG000|Baseline|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
10899086|NCT00560235|BG001|Baseline|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
10899087|NCT00560235|BG002|Baseline|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
10899088|NCT00560235|BG003|Baseline|Total|Total of all reporting groups
10899089|NCT00560235|FG000|Participant Flow|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
10899090|NCT00560235|FG001|Participant Flow|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
10899091|NCT00560235|FG002|Participant Flow|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
10899092|NCT00560235|OG000|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
10899093|NCT00560235|OG000|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
10899094|NCT00560235|OG001|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
10899095|NCT00560235|OG002|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
10899096|NCT00560235|OG000|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
10899097|NCT00560235|OG001|Outcome|Figitumumab 30 mg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
10899098|NCT00560235|OG001|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
10899099|NCT00560235|OG002|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
10899100|NCT00560235|EG000|Reported Event|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
10899101|NCT00560235|EG001|Reported Event|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
10899102|NCT00560235|EG002|Reported Event|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
10899103|NCT00560235|EG003|Reported Event|Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
10899104|NCT00560235|EG004|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
10899105|NCT00560235|EG005|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
10899106|NCT00560235|EG006|Reported Event|Figitumumab 30mg/kg (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle) until unacceptable toxicity or participant withdrawal, for up to 6 cycles.
10899107|NCT00560235|EG007|Reported Event|Figitumumab 30 mg/kg + Rapamycin (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
10899108|NCT00560313|BG000|Baseline|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
10899109|NCT00560313|FG000|Participant Flow|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
10899110|NCT00560313|OG000|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
10899111|NCT00560313|OG001|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
10899112|NCT00560313|OG002|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
10899113|NCT00560313|OG001|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99) strain
10899114|NCT00560313|OG002|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254) strain.
10899115|NCT00560313|OG000|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10899116|NCT00560313|OG001|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
11342275|NCT03703817|BG002|Baseline|Total|Total of all reporting groups
10899117|NCT00560313|OG002|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10899118|NCT00560313|OG003|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
10899119|NCT00560313|OG000|Outcome|4CMenB (Post Dose 1)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 1
10899120|NCT00560313|OG001|Outcome|4CMenB (Post Dose 2)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 2.
10899121|NCT00560313|OG002|Outcome|4CMenB (Post Dose 3)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 3.
10899122|NCT00560313|OG003|Outcome|Men ACWY-CRM (One Dose)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post one dose of Men ACWY vaccine.
10899123|NCT00560313|EG000|Reported Event|4CMenB (1st Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 1."
10899124|NCT00560313|EG001|Reported Event|4CMenB (2nd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 2."
10899125|NCT00560313|EG002|Reported Event|4CMenB (3rd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 3."
10899126|NCT00560313|EG003|Reported Event|Men ACWY-CRM|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 1 MenACWY."
10899127|NCT00560352|BG000|Baseline|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899128|NCT00560352|BG001|Baseline|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899129|NCT00560352|BG002|Baseline|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899130|NCT00560352|BG003|Baseline|Total|Total of all reporting groups
10899131|NCT00560352|FG000|Participant Flow|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899132|NCT00560352|FG001|Participant Flow|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899133|NCT00560352|FG002|Participant Flow|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
11342276|NCT03703817|FG000|Participant Flow|Tofacitinib Citrate|Participants who had been using tofacitinib citrate for more than 6 months or more and less than 2 years for RA treatment were included in the group.
10899134|NCT00560352|OG000|Outcome|All Treated|Dasatinib taken orally every day, once daily (QD) or twice daily (BID), depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
10899135|NCT00560352|OG000|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899136|NCT00560352|OG001|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899137|NCT00560352|OG002|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899138|NCT00560352|OG000|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899139|NCT00560352|OG000|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
10899140|NCT00560352|OG000|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899141|NCT00560352|EG000|Reported Event|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
11171776|NCT02005276|BG002|Baseline|Jackpot Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day.~Jackpot Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day."
11171777|NCT02005276|BG003|Baseline|Combined Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 5 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day.~Combined Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day."
11171778|NCT02005276|BG004|Baseline|Total|Total of all reporting groups
10899142|NCT00560352|EG001|Reported Event|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899143|NCT00560352|EG002|Reported Event|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
10899144|NCT00560391|BG000|Baseline|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899145|NCT00560391|BG001|Baseline|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899146|NCT00560391|BG002|Baseline|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899147|NCT00560391|BG003|Baseline|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899148|NCT00560391|BG004|Baseline|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
10899149|NCT00560391|BG005|Baseline|Total|Total of all reporting groups
10899150|NCT00560391|FG000|Participant Flow|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899151|NCT00560391|FG001|Participant Flow|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899152|NCT00560391|FG002|Participant Flow|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899153|NCT00560391|FG003|Participant Flow|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899154|NCT00560391|FG004|Participant Flow|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
10899155|NCT00560391|OG000|Outcome|All Treated Participants|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
10899156|NCT00560391|OG000|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899157|NCT00560391|OG001|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899158|NCT00560391|OG002|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899159|NCT00560391|OG003|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
11090730|NCT01531205|FG000|Participant Flow|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
11233311|NCT02426138|BG001|Baseline|Usual Care + Choose myPlate Then Meal Delivery|"During the first intervention period, participants in this arm will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the first intervention period will comprise the 'off-meal' data for participants in this arm.~Following this, during the second intervention period, participants will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the second intervention period will comprise the 'on-meal' data for this participants in this arm."
11233312|NCT02426138|BG002|Baseline|Total|Total of all reporting groups
11233313|NCT02426138|FG000|Participant Flow|Meal Delivery Then Usual Care + Choose myPlate|"During the first intervention period, participants in this arm will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the first intervention period will comprise the 'on-meal' data for this participants in this arm.~Following this, during the second intervention period, they will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the second intervention period will comprise the 'off-meal' data for participants in this arm."
11233314|NCT02426138|FG001|Participant Flow|Usual Care + Choose myPlate Then Meal Delivery|"During the first intervention period, participants in this arm will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the first intervention period will comprise the 'off-meal' data for participants in this arm.~Following this, during the second intervention period, participants will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the second intervention period will comprise the 'on-meal' data for this participants in this arm."
11233315|NCT02426138|OG000|Outcome|On Meals|Outcome recorded while receiving medically tailored meals
11233316|NCT02426138|OG001|Outcome|Off Meals|Outcome recorded while not receiving meals
11233317|NCT02426138|OG000|Outcome|On-Meals|Outcome recorded while receiving medically tailored meals
11233318|NCT02426138|OG001|Outcome|Off-Meals|Outcome recorded while not receiving meals
11233319|NCT02426138|EG000|Reported Event|Medically Tailored Meal Delivery|"Participants will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure.~Medically Tailored Meal Delivery (MTM): Patients will receive delivery of medically tailored meals for 12 weeks~Usual Care + Choose MyPlate: Patients will receive usual diabetes care + a Choose MyPlate healthy eating brochure"
11233320|NCT02426138|EG001|Reported Event|Usual Care + Choose Myplate (Delayed)|"Participants will receive usual diabetes care and a Choose MyPlate healthy eating brochure for 12 weeks.~Usual Care + Choose MyPlate: Patients will receive usual diabetes care + a Choose MyPlate healthy eating brochure~They will then receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet"
11233321|NCT02426476|BG000|Baseline|Active HRVB Training|"Heart rate variability biofeedback training~active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state"
11233322|NCT02426476|BG001|Baseline|Sham HRVB Training|"passive relaxation~sham HRVB training: passive relaxation"
11233323|NCT02426476|BG002|Baseline|Total|Total of all reporting groups
11233324|NCT02426476|FG000|Participant Flow|Active HRVB Training|"Heart rate variability biofeedback training~active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state"
11233325|NCT02426476|FG001|Participant Flow|Sham HRVB Training|"passive relaxation~sham HRVB training: passive relaxation"
11233326|NCT02426476|OG000|Outcome|Active HRVB Training|"Heart rate variability biofeedback training~active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state"
11233327|NCT02426476|OG001|Outcome|Sham HRVB Training|"passive relaxation~sham HRVB training: passive relaxation"
11233328|NCT02426476|OG000|Outcome|HRV Biofeedback|active intervention
11233329|NCT02426476|OG001|Outcome|Sham HRVB Training|passive relaxation control group
11233330|NCT02426476|EG000|Reported Event|Active HRVB Training|"Heart rate variability biofeedback training~active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state"
11233331|NCT02426476|EG001|Reported Event|Sham HRVB Training|"passive relaxation~sham HRVB training: passive relaxation"
11233332|NCT02426541|BG000|Baseline|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
11233333|NCT02426541|BG001|Baseline|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
11233334|NCT02426541|BG002|Baseline|Total|Total of all reporting groups
11233335|NCT02426541|FG000|Participant Flow|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
11233336|NCT02426541|FG001|Participant Flow|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
10899160|NCT00560391|OG004|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
10899161|NCT00560391|EG000|Reported Event|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899162|NCT00560391|EG001|Reported Event|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899163|NCT00560391|EG002|Reported Event|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
10899164|NCT00560391|EG003|Reported Event|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899165|NCT00560391|EG004|Reported Event|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
10899166|NCT00560404|BG000|Baseline|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
10899167|NCT00560404|BG001|Baseline|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
10899168|NCT00560404|BG002|Baseline|Total|Total of all reporting groups
10899169|NCT00560404|FG000|Participant Flow|C.E.R.A.|Participants received RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A.]) with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
10899170|NCT00560404|FG001|Participant Flow|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
10899171|NCT00560404|OG000|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
10899172|NCT00560404|OG001|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
10899173|NCT00560404|EG000|Reported Event|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
10899174|NCT00560404|EG001|Reported Event|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
10899175|NCT00560417|BG000|Baseline|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
10899176|NCT00560417|BG001|Baseline|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
10899177|NCT00560417|BG002|Baseline|Total|Total of all reporting groups
10899178|NCT00560417|FG000|Participant Flow|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
10899179|NCT00560417|FG001|Participant Flow|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
10899180|NCT00560417|OG000|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
10899181|NCT00560417|OG001|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
10899182|NCT00560417|EG000|Reported Event|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
10899183|NCT00560417|EG001|Reported Event|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
10899184|NCT00560508|BG000|Baseline|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
10899185|NCT00560508|BG001|Baseline|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
10899186|NCT00560508|BG002|Baseline|Total|Total of all reporting groups
10899187|NCT00560508|FG000|Participant Flow|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
10899188|NCT00560508|FG001|Participant Flow|Pramipexole Immediate Release Group (PPX IR)|Pramipexole Immediate Release (IR) tablets of 0.125 mg and 0.5 mg dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
10899189|NCT00560508|OG000|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
10899190|NCT00560508|OG001|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
10899191|NCT00560508|OG000|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
11171779|NCT02005276|FG000|Participant Flow|Control|Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day.
10899192|NCT00560508|OG001|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
10899193|NCT00560508|OG001|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
10899194|NCT00560508|OG000|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open label period
10899195|NCT00560508|OG000|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
10899196|NCT00560508|EG000|Reported Event|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
10899197|NCT00560508|EG001|Reported Event|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
10899198|NCT00560560|BG000|Baseline|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
10899199|NCT00560560|BG001|Baseline|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
10899200|NCT00560560|BG002|Baseline|Total|Total of all reporting groups
10899201|NCT00560560|FG000|Participant Flow|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
10899202|NCT00560560|FG001|Participant Flow|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
10899203|NCT00560560|OG000|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
10899204|NCT00560560|OG001|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
10899205|NCT00560560|EG000|Reported Event|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
10899206|NCT00560560|EG001|Reported Event|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
10899207|NCT00560573|BG000|Baseline|All Participants|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
10899208|NCT00560573|FG000|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899209|NCT00560573|FG001|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899210|NCT00560573|FG002|Participant Flow|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10915193|NCT00634543|BG001|Baseline|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
10915194|NCT00634543|BG002|Baseline|Total|Total of all reporting groups
10899211|NCT00560573|FG003|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The recommended phase 2 dose (R2PD) of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899212|NCT00560573|FG004|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899213|NCT00560573|FG005|Participant Flow|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg, was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
10899214|NCT00560573|OG000|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899215|NCT00560573|OG001|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899216|NCT00560573|OG002|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899217|NCT00560573|OG000|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899218|NCT00560573|OG001|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899219|NCT00560573|OG003|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899220|NCT00560573|OG000|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899221|NCT00560573|OG000|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899222|NCT00560573|OG001|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899223|NCT00560573|OG002|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
10899224|NCT00560573|OG003|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
11090731|NCT01531205|OG000|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
11174201|NCT02020252|EG000|Reported Event|Touchscreen Participants|"New lung, gastric and pancreatic cancer patients presenting to the University of Chicago outpatient oncology clinics, a large research institution located on Chicago's Southside, were identified for study accrual, using the electronic scheduling system.~Testing an interactive technology in a diverse health literary population: Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. We tested an interactive technology designed for patients with diverse health literacy skills aimed at improving patient receptiveness, willingness, knowledge, self-efficacy and positive attitudes regarding clinical trials."
10899225|NCT00560573|OG001|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 (absence) and on Day 1 of each cycle (presence) thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899226|NCT00560573|OG000|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
10899227|NCT00560573|OG001|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
10899228|NCT00560573|OG000|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
10899229|NCT00560573|OG001|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899230|NCT00560573|OG002|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
10899231|NCT00560573|OG000|Outcome|Overall Population With PR and CR|Participants with PR and CR who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants with PR and CR who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
10899232|NCT00560573|OG003|Outcome|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899233|NCT00560573|OG004|Outcome|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899234|NCT00560573|OG005|Outcome|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
10899235|NCT00560573|OG000|Outcome|Overall Participapnts|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
10899236|NCT00560573|EG000|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899237|NCT00560573|EG001|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899238|NCT00560573|EG002|Reported Event|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899239|NCT00560573|EG003|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899240|NCT00560573|EG004|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
10899241|NCT00560573|EG005|Reported Event|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
10899242|NCT00560612|BG000|Baseline|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
10899243|NCT00560612|BG001|Baseline|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
10899244|NCT00560612|BG002|Baseline|Total|Total of all reporting groups
10899245|NCT00560612|FG000|Participant Flow|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
10899246|NCT00560612|FG001|Participant Flow|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
10899247|NCT00560612|OG000|Outcome|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
10899248|NCT00560612|OG001|Outcome|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
10899249|NCT00560612|EG000|Reported Event|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
10899250|NCT00560612|EG001|Reported Event|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
10899251|NCT00560703|BG000|Baseline|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
10899252|NCT00560703|BG001|Baseline|Placebo|Sugar capsule, once per day for 84 days
10899253|NCT00560703|BG002|Baseline|Total|Total of all reporting groups
10899254|NCT00560703|FG000|Participant Flow|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
10899255|NCT00560703|FG001|Participant Flow|Placebo|Sugar capsule, once per day for 84 days
10899256|NCT00560703|OG000|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
10899257|NCT00560703|OG001|Outcome|Placebo|Sugar capsule, once per day for 84 days
10899258|NCT00560703|EG000|Reported Event|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
10899259|NCT00560703|EG001|Reported Event|Placebo|Sugar capsule, once per day for 84 days
10899260|NCT00560755|BG000|Baseline|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
10899261|NCT00560755|FG000|Participant Flow|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
10899262|NCT00560755|OG000|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
10899263|NCT00560755|EG000|Reported Event|ProQuad® Arm: Dose 2|Healthy infants (12 to 22 months of age) received ProQuad® Dose 2 on Day 28 to Day 42.
10899264|NCT00560755|EG001|Reported Event|ProQuad® Arm: Dose 1|Healthy infants (12 to 22 months of age) received ProQuad® Dose 1 on Day 1.
10899265|NCT00560794|BG000|Baseline|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
11171780|NCT02005276|FG001|Participant Flow|Basic Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day.~Basic Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day."
11171781|NCT02005276|FG002|Participant Flow|Jackpot Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day.~Jackpot Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day."
11171782|NCT02005276|FG003|Participant Flow|Combined Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 5 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day.~Combined Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day."
11171783|NCT02005276|OG000|Outcome|Control|Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day.
11171784|NCT02005276|OG001|Outcome|Basic Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day.~Basic Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day."
10899266|NCT00560794|FG000|Participant Flow|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
10899267|NCT00560794|OG000|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
10899268|NCT00560794|OG000|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
10899269|NCT00560794|OG000|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
10899270|NCT00560794|EG000|Reported Event|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
10899271|NCT00560833|BG000|Baseline|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
10899272|NCT00560833|BG001|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899273|NCT00560833|BG002|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899274|NCT00560833|BG003|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899275|NCT00560833|BG004|Baseline|Esmertazapine 18 mg|Participants receive esmertazapine 18 mg, encapsulated tablet, PO, QD for up to 12 weeks
10899276|NCT00560833|BG005|Baseline|Total|Total of all reporting groups
10899277|NCT00560833|FG000|Participant Flow|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
10899278|NCT00560833|FG001|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899279|NCT00560833|FG002|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899280|NCT00560833|FG003|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899281|NCT00560833|FG004|Participant Flow|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899282|NCT00560833|OG000|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
11233337|NCT02426541|OG000|Outcome|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
10899283|NCT00560833|OG001|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899284|NCT00560833|OG002|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899285|NCT00560833|OG003|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899286|NCT00560833|OG004|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899287|NCT00560833|EG000|Reported Event|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
10899288|NCT00560833|EG001|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899289|NCT00560833|EG002|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899290|NCT00560833|EG003|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899291|NCT00560833|EG004|Reported Event|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
10899292|NCT00560859|BG000|Baseline|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
10899293|NCT00560859|BG001|Baseline|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
10899294|NCT00560859|BG002|Baseline|Total|Total of all reporting groups
10899295|NCT00560859|FG000|Participant Flow|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
10899296|NCT00560859|FG001|Participant Flow|Watchful Waiting|"Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
10899297|NCT00560859|OG000|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
10899298|NCT00560859|OG001|Outcome|Watchful Waiting|"Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
10899299|NCT00560859|OG001|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
10899300|NCT00560859|EG000|Reported Event|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
10899301|NCT00560859|EG001|Reported Event|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
10899302|NCT00560885|BG000|Baseline|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
10899303|NCT00560885|FG000|Participant Flow|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
10899304|NCT00560885|OG000|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
10899305|NCT00560885|EG000|Reported Event|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
11233338|NCT02426541|OG001|Outcome|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
11233339|NCT02426541|EG000|Reported Event|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
10899306|NCT00560937|BG000|Baseline|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
10899307|NCT00560937|BG001|Baseline|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
10899308|NCT00560937|BG002|Baseline|Total|Total of all reporting groups
10899309|NCT00560937|FG000|Participant Flow|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
10899310|NCT00560937|FG001|Participant Flow|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
10899311|NCT00560937|OG000|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
10899312|NCT00560937|OG001|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
11233340|NCT02426541|EG001|Reported Event|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
10899313|NCT00560937|EG000|Reported Event|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
10899314|NCT00560937|EG001|Reported Event|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
10899315|NCT00560950|BG000|Baseline|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
10899316|NCT00560950|BG001|Baseline|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
10899317|NCT00560950|BG002|Baseline|Total|Total of all reporting groups
10899318|NCT00560950|FG000|Participant Flow|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
10899319|NCT00560950|FG001|Participant Flow|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
10899320|NCT00560950|OG000|Outcome|1st Revaccination Group Day 1|
10899321|NCT00560950|OG001|Outcome|1st Revaccination Group Day 30|
10899322|NCT00560950|OG002|Outcome|2nd Revaccination Group Day 1|
10899323|NCT00560950|OG003|Outcome|2nd Revaccination Group Day 30|
10899324|NCT00560950|EG000|Reported Event|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
10899325|NCT00560950|EG001|Reported Event|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
10899326|NCT00561002|BG000|Baseline|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
10899327|NCT00561002|BG001|Baseline|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
10899328|NCT00561002|BG002|Baseline|Total|Total of all reporting groups
10899329|NCT00561002|FG000|Participant Flow|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
10899330|NCT00561002|FG001|Participant Flow|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
10899331|NCT00561002|OG000|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
10899332|NCT00561002|OG001|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
10899333|NCT00561002|EG000|Reported Event|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
10899334|NCT00561002|EG001|Reported Event|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
10899335|NCT00561015|BG000|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
10899336|NCT00561015|BG001|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899337|NCT00561015|BG002|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
11233341|NCT02426580|BG000|Baseline|Intervention With Wechat Group|"The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.~wechat: The wechat model of dietary education every 1 month by cellphone"
10899338|NCT00561015|BG003|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
10899339|NCT00561015|BG004|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899340|NCT00561015|BG005|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899341|NCT00561015|BG006|Baseline|Total|Total of all reporting groups
10899342|NCT00561015|FG000|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
10899343|NCT00561015|FG001|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899344|NCT00561015|FG002|Participant Flow|Pbo With Peg-IFN-alfa-2a+ RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899345|NCT00561015|FG003|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
10899346|NCT00561015|FG004|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899347|NCT00561015|FG005|Participant Flow|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899348|NCT00561015|OG000|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
11090732|NCT01531205|OG000|Outcome|Participant One|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
11090733|NCT01531205|OG001|Outcome|Participant Two|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
11090734|NCT01531205|EG000|Reported Event|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
11090735|NCT01531335|BG000|Baseline|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
11090736|NCT01531335|BG001|Baseline|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
10899349|NCT00561015|OG001|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899350|NCT00561015|OG002|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899351|NCT00561015|OG003|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
10899352|NCT00561015|OG004|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899353|NCT00561015|OG005|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899354|NCT00561015|OG002|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
10899355|NCT00561015|OG003|Outcome|TVR With Peg-IFN-alfa-2a on + RBV (T2/PR24) - Genotype 3|Participants who were never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899356|NCT00561015|OG003|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899357|NCT00561015|OG002|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899358|NCT00561015|EG000|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
10899359|NCT00561015|EG001|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899360|NCT00561015|EG002|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
11090737|NCT01531335|BG002|Baseline|Total|Total of all reporting groups
11090738|NCT01531335|FG000|Participant Flow|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
10899361|NCT00561015|EG003|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
10899362|NCT00561015|EG004|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899363|NCT00561015|EG005|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
10899364|NCT00561080|BG000|Baseline|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
10899365|NCT00561080|BG001|Baseline|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
10899366|NCT00561080|BG002|Baseline|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
10899367|NCT00561080|BG003|Baseline|Total|Total of all reporting groups
10899368|NCT00561080|FG000|Participant Flow|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
10899369|NCT00561080|FG001|Participant Flow|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
10899370|NCT00561080|FG002|Participant Flow|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
10899371|NCT00561080|OG000|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
10899372|NCT00561080|OG001|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
10899373|NCT00561080|OG000|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
11090739|NCT01531335|FG001|Participant Flow|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
10899374|NCT00561080|OG001|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
10899375|NCT00561080|OG002|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
10899376|NCT00561080|EG000|Reported Event|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
10899377|NCT00561080|EG001|Reported Event|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
10899378|NCT00561080|EG002|Reported Event|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
11090740|NCT01531335|OG000|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
11090741|NCT01531335|OG001|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
10899379|NCT00561145|BG000|Baseline|Young Men|Young men: 20-40 years of age
10899380|NCT00561145|BG001|Baseline|Elderly Men|Elderly men: 65-85 years of age
10899381|NCT00561145|BG002|Baseline|Total|Total of all reporting groups
10899382|NCT00561145|FG000|Participant Flow|Young Men|"Young men should be 20-40 years of age. Men will be excluded based on the following exclusion criteria:~body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
11090742|NCT01531335|EG000|Reported Event|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
11090743|NCT01531335|EG001|Reported Event|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
11090744|NCT01531439|BG000|Baseline|Naloxone Infusion 0.5 mcg/kg/hr|Naloxone: Naloxone infusion 0.5 mcg/kg/hr
11090745|NCT01531439|BG001|Baseline|Naloxone 2.5 mcg/kg/hr|"Naloxone infusion 2.5 mcg/kg/hr~Naloxone: Naloxone infusion 2.5 mcg/kg/hr"
11090746|NCT01531439|BG002|Baseline|Total|Total of all reporting groups
11090747|NCT01531439|FG000|Participant Flow|Naloxone Infusion 0.5 mcg/kg/hr|Naloxone: Naloxone infusion 0.5 mcg/kg/hr
11090748|NCT01531439|FG001|Participant Flow|Naloxone 2.5 mcg/kg/hr|"Naloxone infusion 2.5 mcg/kg/hr~Naloxone: Naloxone infusion 2.5 mcg/kg/hr"
11090749|NCT01531439|OG000|Outcome|Naloxone Infusion 0.5 mcg/kg/hr|Naloxone: Naloxone infusion 0.5 mcg/kg/hr
11090750|NCT01531439|OG001|Outcome|Naloxone 2.5 mcg/kg/hr|"Naloxone infusion 2.5 mcg/kg/hr~Naloxone: Naloxone infusion 2.5 mcg/kg/hr"
11090751|NCT01531439|EG000|Reported Event|Naloxone Infusion 0.5 mcg/kg/hr|Naloxone: Naloxone infusion 0.5 mcg/kg/hr
11090752|NCT01531439|EG001|Reported Event|Naloxone 2.5 mcg/kg/hr|"Naloxone infusion 2.5 mcg/kg/hr~Naloxone: Naloxone infusion 2.5 mcg/kg/hr"
11090753|NCT01531673|BG000|Baseline|Group 1-6d Combined: Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
10899383|NCT00561145|FG001|Participant Flow|Elderly Men|"Elderly men should be 65-85 years of age. Men will be excluded based on the following exclusion criteria:~body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
10899384|NCT00561145|OG000|Outcome|Young Men|Young men: 20-40 years of age
10899385|NCT00561145|OG001|Outcome|Elderly Men|Elderly men: 65-85 years of age
10899386|NCT00561145|EG000|Reported Event|Young Men|Young men: 20-40 years of age
10899387|NCT00561145|EG001|Reported Event|Elderly Men|Elderly men: 65-85 years of age
10899388|NCT00561340|BG000|Baseline|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
10899389|NCT00561340|BG001|Baseline|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
10899390|NCT00561340|BG002|Baseline|Total|Total of all reporting groups
11233342|NCT02426580|BG001|Baseline|Controlled Group|Only conventional education every 3 months during routing clinical visit. The patients is Prospectively and retrospectively enrolled
10899391|NCT00561340|FG000|Participant Flow|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
10899392|NCT00561340|FG001|Participant Flow|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
10899393|NCT00561340|OG000|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
10899394|NCT00561340|OG001|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
10899395|NCT00561340|EG000|Reported Event|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
10899396|NCT00561340|EG001|Reported Event|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
10899397|NCT00561353|BG000|Baseline|TMC435 25 mg (Cohort 1)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899398|NCT00561353|BG001|Baseline|TMC435 75mg (Cohort 1)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899399|NCT00561353|BG002|Baseline|Placebo (Cohort 1)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899400|NCT00561353|BG003|Baseline|TMC435 200 mg (Cohort 2)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899401|NCT00561353|BG004|Baseline|Placebo (Cohort 2)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899402|NCT00561353|BG005|Baseline|TMC435 75 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899403|NCT00561353|BG006|Baseline|TMC435 150 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899404|NCT00561353|BG007|Baseline|TMC435 200 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899405|NCT00561353|BG008|Baseline|Placebo (Cohort 4)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899406|NCT00561353|BG009|Baseline|TMC435 200 mg (Cohort 5)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899407|NCT00561353|BG010|Baseline|Total|Total of all reporting groups
10899408|NCT00561353|FG000|Participant Flow|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899409|NCT00561353|FG001|Participant Flow|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
11233343|NCT02426580|BG002|Baseline|Total|Total of all reporting groups
11233344|NCT02426580|FG000|Participant Flow|Intervention With Wechat Group|"The wechat model will provide information of protein, calcium, phosphorus and protein intake, which were suggested by the current KDIGO/ KDOQI guideline.~wechat: The wechat model of dietary education every 1 month by cellphone"
10899410|NCT00561353|FG002|Participant Flow|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899411|NCT00561353|FG003|Participant Flow|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899412|NCT00561353|FG004|Participant Flow|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899413|NCT00561353|FG005|Participant Flow|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899414|NCT00561353|FG006|Participant Flow|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899415|NCT00561353|FG007|Participant Flow|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899416|NCT00561353|FG008|Participant Flow|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899417|NCT00561353|FG009|Participant Flow|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899418|NCT00561353|OG000|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
10899419|NCT00561353|OG001|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
10899420|NCT00561353|OG002|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
10899421|NCT00561353|OG003|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
10899422|NCT00561353|OG004|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
10899423|NCT00561353|OG000|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
10899424|NCT00561353|OG001|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899425|NCT00561353|OG002|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899426|NCT00561353|OG003|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899427|NCT00561353|OG004|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899428|NCT00561353|OG000|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
10899429|NCT00561353|OG001|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899430|NCT00561353|OG002|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899431|NCT00561353|OG003|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899432|NCT00561353|OG004|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899433|NCT00561353|OG004|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
10899434|NCT00561353|OG003|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899435|NCT00561353|OG000|Outcome|TMC435 25 (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
10899436|NCT00561353|OG002|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg and 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
11090754|NCT01531673|BG001|Baseline|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
10899437|NCT00561353|OG000|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899438|NCT00561353|OG001|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899439|NCT00561353|OG002|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899440|NCT00561353|OG003|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899441|NCT00561353|OG004|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899442|NCT00561353|OG002|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo identical in appearance toTMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
10899443|NCT00561353|OG000|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
10899444|NCT00561353|OG001|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
11171785|NCT02005276|OG002|Outcome|Jackpot Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day.~Jackpot Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day."
11233345|NCT02426580|FG001|Participant Flow|Controlled Group|Only conventional education every 3 months during routing clinical visit
11233346|NCT02426580|OG000|Outcome|Intervention With Wechat Group|"The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.~wechat: The wechat model of dietary education every 1 month by cellphone"
10899445|NCT00561353|OG000|Outcome|TMC435 25 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899446|NCT00561353|OG001|Outcome|TMC435 75 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899447|NCT00561353|OG002|Outcome|Placebo (Cohort 1, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899448|NCT00561353|OG003|Outcome|TMC435 200 mg (Cohort 2, Panels A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899449|NCT00561353|OG004|Outcome|Placebo (Cohort 2, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899450|NCT00561353|OG003|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899451|NCT00561353|OG001|Outcome|TMC435 75 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899452|NCT00561353|OG002|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899453|NCT00561353|OG003|Outcome|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899454|NCT00561353|OG004|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers in Cohort 5, Panel D received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899455|NCT00561353|OG001|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899456|NCT00561353|OG002|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
10899457|NCT00561353|OG003|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899458|NCT00561353|OG002|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
10899459|NCT00561353|OG003|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899460|NCT00561353|OG004|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899461|NCT00561353|OG005|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899462|NCT00561353|OG000|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon (PegIFNα-2a) on Days 1, 8, 15, and 22.
10899463|NCT00561353|OG003|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899464|NCT00561353|OG003|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899465|NCT00561353|OG004|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899466|NCT00561353|OG002|Outcome|TTMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
11233347|NCT02426580|OG001|Outcome|Controlled Group|Only conventional education every 3 months during routing clinical visit
10899467|NCT00561353|EG000|Reported Event|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899468|NCT00561353|EG001|Reported Event|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899469|NCT00561353|EG002|Reported Event|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899470|NCT00561353|EG003|Reported Event|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
11233348|NCT02426580|EG000|Reported Event|Intervention With Wechat Group|"The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.~wechat: The wechat model of dietary education every 1 month by cellphone"
10899471|NCT00561353|EG004|Reported Event|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
10899472|NCT00561353|EG005|Reported Event|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899473|NCT00561353|EG006|Reported Event|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899474|NCT00561353|EG007|Reported Event|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899475|NCT00561353|EG008|Reported Event|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
11233349|NCT02426580|EG001|Reported Event|Controlled Group|Only conventional education every 3 months during routing clinical visit. The patients is Prospectively and retrospectively enrolled
10899476|NCT00561353|EG009|Reported Event|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
10899477|NCT00561353|EG010|Reported Event|All TMC435 (All Cohorts)|
10899478|NCT00561392|BG000|Baseline|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
10899479|NCT00561392|FG000|Participant Flow|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
10899480|NCT00561392|OG000|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
10899481|NCT00561392|EG000|Reported Event|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
10899482|NCT00561418|BG000|Baseline|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
10899483|NCT00561418|FG000|Participant Flow|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post Hematopoietic Stem Cell Transplantation),days +56 to +66 (≈2 mos), and at Cycle 2 Day 1 (≈3 mos.), Cycle 3 Day 1 (≈4 mos.), Cycle 5 Day 1 (≈6 mos.),Cycle 7 Day 1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
10899484|NCT00561418|OG000|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
10899485|NCT00561418|EG000|Reported Event|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
10899486|NCT00561431|BG000|Baseline|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
10899487|NCT00561431|BG001|Baseline|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
10899488|NCT00561431|BG002|Baseline|Total|Total of all reporting groups
10899489|NCT00561431|FG000|Participant Flow|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
10899490|NCT00561431|FG001|Participant Flow|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
11090755|NCT01531673|BG002|Baseline|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
11090756|NCT01531673|BG003|Baseline|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10899491|NCT00561431|OG000|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
10899492|NCT00561431|OG001|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
10899493|NCT00561431|EG000|Reported Event|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
11090757|NCT01531673|BG004|Baseline|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
11090758|NCT01531673|BG005|Baseline|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090759|NCT01531673|BG006|Baseline|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10899494|NCT00561431|EG001|Reported Event|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
10899495|NCT00561457|BG000|Baseline|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
10899496|NCT00561457|FG000|Participant Flow|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
10899497|NCT00561457|OG000|Outcome|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
10899498|NCT00561457|EG000|Reported Event|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
11090760|NCT01531673|BG007|Baseline|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
10899499|NCT00561470|BG000|Baseline|Placebo/Folfiri|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
10899500|NCT00561470|BG001|Baseline|Aflibercept/Folfiri|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
10899501|NCT00561470|BG002|Baseline|Total|Total of all reporting groups
10899502|NCT00561470|FG000|Participant Flow|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
10899503|NCT00561470|FG001|Participant Flow|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
10899504|NCT00561470|OG000|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
10899505|NCT00561470|OG001|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
11090761|NCT01531673|BG008|Baseline|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090762|NCT01531673|BG009|Baseline|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
11090763|NCT01531673|BG010|Baseline|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090764|NCT01531673|BG011|Baseline|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090765|NCT01531673|BG012|Baseline|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090766|NCT01531673|BG013|Baseline|Total|Total of all reporting groups
11090767|NCT01531673|FG000|Participant Flow|Group 1-6d Combined: Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
11090768|NCT01531673|FG001|Participant Flow|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 milligram (mg) tablet orally once daily (qd) for up to 28 days.
11090769|NCT01531673|FG002|Participant Flow|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet every 12 hours (q12h) for up to 28 days.
11090770|NCT01531673|FG003|Participant Flow|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090771|NCT01531673|FG004|Participant Flow|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
11090772|NCT01531673|FG005|Participant Flow|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090773|NCT01531673|FG006|Participant Flow|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090774|NCT01531673|FG007|Participant Flow|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
11090775|NCT01531673|FG008|Participant Flow|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090776|NCT01531673|FG009|Participant Flow|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
11090777|NCT01531673|FG010|Participant Flow|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090778|NCT01531673|FG011|Participant Flow|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090779|NCT01531673|FG012|Participant Flow|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090780|NCT01531673|OG000|Outcome|Group 1-6d Combined: Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
11090781|NCT01531673|OG001|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
11090782|NCT01531673|OG002|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
11090783|NCT01531673|OG003|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10899506|NCT00561470|OG000|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
10899507|NCT00561470|OG001|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
10899508|NCT00561470|EG000|Reported Event|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
10899509|NCT00561470|EG001|Reported Event|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
10899510|NCT00561574|BG000|Baseline|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
10899511|NCT00561574|BG001|Baseline|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
10899512|NCT00561574|BG002|Baseline|Total|Total of all reporting groups
10899513|NCT00561574|FG000|Participant Flow|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
10899514|NCT00561574|FG001|Participant Flow|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
10899515|NCT00561574|OG000|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
10899516|NCT00561574|OG001|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
10899517|NCT00561574|EG000|Reported Event|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
10899518|NCT00561574|EG001|Reported Event|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
10899519|NCT00561600|BG000|Baseline|ASR XL|ASR™-XL Acetabular Cup System
10899520|NCT00561600|BG001|Baseline|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
10899521|NCT00561600|BG002|Baseline|Total|Total of all reporting groups
10899522|NCT00561600|FG000|Participant Flow|A ASR™-XL|ASR™-XL Modular Acetabular Cup System stem
10899523|NCT00561600|FG001|Participant Flow|B Pinnacle™|Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
10899524|NCT00561600|OG000|Outcome|ASR XL Acetabular Cup System|
10899525|NCT00561600|OG001|Outcome|Pinnacle Acetabular Cup System|
10899526|NCT00561600|OG000|Outcome|ASR XL|ASR™-XL Acetabular Cup System
11090784|NCT01531673|OG004|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
10899527|NCT00561600|OG001|Outcome|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
10899528|NCT00561600|EG000|Reported Event|ASR XL Acetabular Cup System|
10899529|NCT00561600|EG001|Reported Event|Pinnacle Acetabular Cup System|
10899530|NCT00561652|BG000|Baseline|Arm 1|Education plus exercise
10899531|NCT00561652|BG001|Baseline|Arm 2|Chiropractic treatment plus Education plus exercise
10899532|NCT00561652|BG002|Baseline|Total|Total of all reporting groups
10899533|NCT00561652|FG000|Participant Flow|Arm 1|Education plus exercise
10899534|NCT00561652|FG001|Participant Flow|Arm 2|Chiropractic treatment plus education plus exercise
10899535|NCT00561652|OG000|Outcome|Arm 1|Education plus exercise
10899536|NCT00561652|OG001|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
10899537|NCT00561652|EG000|Reported Event|Arm 1|Education plus exercise
10899538|NCT00561652|EG001|Reported Event|Arm 2|Chiropractic treatment plus education plus exercise
10899539|NCT00561678|BG000|Baseline|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
10899540|NCT00561678|BG001|Baseline|Placebo|Placebo - normal saline 0.5/ug/kg/hr
10899541|NCT00561678|BG002|Baseline|Total|Total of all reporting groups
10899542|NCT00561678|FG000|Participant Flow|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
10899543|NCT00561678|FG001|Participant Flow|Placebo|Placebo - normal saline 0.5/ug/kg/hr
10899544|NCT00561678|OG000|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
10899545|NCT00561678|OG001|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
10899546|NCT00561678|EG000|Reported Event|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
10899547|NCT00561678|EG001|Reported Event|Placebo|Placebo - normal saline 0.5/ug/kg/hr
10899548|NCT00561730|BG000|Baseline|Pantoprazole|All patients enrolled
10899549|NCT00561730|FG000|Participant Flow|Pantoprazole|All patients enrolled
10899550|NCT00561730|OG000|Outcome|Pantoprazole|All patients with valid value at least at day 0
10899551|NCT00561730|OG000|Outcome|Pantoprazole|All patients with valid values at first and last visit
10899552|NCT00561730|OG000|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
10899553|NCT00561730|EG000|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
10899554|NCT00561821|BG000|Baseline|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899555|NCT00561821|BG001|Baseline|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899556|NCT00561821|BG002|Baseline|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899557|NCT00561821|BG003|Baseline|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
10899558|NCT00561821|BG004|Baseline|Total|Total of all reporting groups
10899559|NCT00561821|FG000|Participant Flow|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899560|NCT00561821|FG001|Participant Flow|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899561|NCT00561821|FG002|Participant Flow|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899562|NCT00561821|FG003|Participant Flow|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
10899563|NCT00561821|OG000|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899564|NCT00561821|OG001|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899565|NCT00561821|OG002|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899566|NCT00561821|OG003|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
10899567|NCT00561821|EG000|Reported Event|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899568|NCT00561821|EG001|Reported Event|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899569|NCT00561821|EG002|Reported Event|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
10899570|NCT00561821|EG003|Reported Event|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
10899571|NCT00561834|BG000|Baseline|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
10899572|NCT00561834|FG000|Participant Flow|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
10899573|NCT00561834|OG000|Outcome|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
10899574|NCT00561834|EG000|Reported Event|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
10899575|NCT00561925|BG000|Baseline|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
10899576|NCT00561925|BG001|Baseline|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
10899577|NCT00561925|BG002|Baseline|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
10899578|NCT00561925|BG003|Baseline|Total|Total of all reporting groups
10899579|NCT00561925|FG000|Participant Flow|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
10899580|NCT00561925|FG001|Participant Flow|NVP IR 200mg BID|Nevirapine immediate release 200 mg given twice daily
10899581|NCT00561925|FG002|Participant Flow|NVP XR 400mg QD|Nevirapine extended release 400 mg given once daily
10899582|NCT00561925|FG003|Participant Flow|NVP XR|
10899583|NCT00561925|FG004|Participant Flow|NVP IR to XR|
10899584|NCT00561925|OG000|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
10899585|NCT00561925|OG001|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
10899586|NCT00561925|OG002|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
10899587|NCT00561925|OG000|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
10899588|NCT00561925|OG001|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
10899589|NCT00561925|OG002|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
10899590|NCT00561925|OG003|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
10899591|NCT00561925|OG000|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
10899592|NCT00561925|OG001|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
10899593|NCT00561925|OG000|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
10899594|NCT00561925|OG003|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously received nevirapine IR during the pre week 144
10899595|NCT00561925|EG000|Reported Event|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
10899596|NCT00561925|EG001|Reported Event|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
10899597|NCT00561925|EG002|Reported Event|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
10899598|NCT00561925|EG003|Reported Event|NVP IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
10899599|NCT00561925|EG004|Reported Event|NVP XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously receiving nevirapine IR during the pre week 144
10899600|NCT00561951|BG000|Baseline|Placebo|Subjects were treated with placebo once daily for 12 weeks.
10899601|NCT00561951|BG001|Baseline|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
10899602|NCT00561951|BG002|Baseline|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
10899603|NCT00561951|BG003|Baseline|Total|Total of all reporting groups
10899604|NCT00561951|FG000|Participant Flow|Placebo|Subjects were treated with placebo once daily for 12 weeks.
10899605|NCT00561951|FG001|Participant Flow|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
10899606|NCT00561951|FG002|Participant Flow|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
10899607|NCT00561951|OG000|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
10899608|NCT00561951|OG001|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
10899609|NCT00561951|OG002|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
10899610|NCT00561951|EG000|Reported Event|Placebo|Subjects were treated with placebo once daily for 12 weeks.
10899611|NCT00561951|EG001|Reported Event|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
10899612|NCT00561951|EG002|Reported Event|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
10899613|NCT00561977|BG000|Baseline|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
10899614|NCT00561977|BG001|Baseline|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
10899615|NCT00561977|BG002|Baseline|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
10899616|NCT00561977|BG003|Baseline|Total|Total of all reporting groups
10899617|NCT00561977|FG000|Participant Flow|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
10899618|NCT00561977|FG001|Participant Flow|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
10899619|NCT00561977|FG002|Participant Flow|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
10899620|NCT00561977|OG000|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
10899621|NCT00561977|OG001|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
10899622|NCT00561977|OG002|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
10899623|NCT00561977|EG000|Reported Event|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
10899624|NCT00561977|EG001|Reported Event|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
10899625|NCT00561977|EG002|Reported Event|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
10899626|NCT00562094|BG000|Baseline|Pantoprazole|All patients enrolled
10899627|NCT00562094|FG000|Participant Flow|Pantoprazole|All patients enrolled
11090785|NCT01531673|OG005|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10899628|NCT00562094|OG000|Outcome|Pantoprazole / Start of Therapy|All patients with valid values ('as observed')
10899629|NCT00562094|OG001|Outcome|Pantoprazole / End of Therapy|All patients with valid values ('as observed')
10899630|NCT00562094|OG000|Outcome|Pantoprazole|All patients with valid values ('as observed')
10899631|NCT00562094|OG000|Outcome|Pantoprazole|All patients with valid values at first and last visit
10899632|NCT00562094|OG000|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
10899633|NCT00562094|EG000|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
10899634|NCT00562120|BG000|Baseline|Entire Study Population|All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first).
10899635|NCT00562120|FG000|Participant Flow|PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D|PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
10915195|NCT00634543|FG000|Participant Flow|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
10899636|NCT00562120|FG001|Participant Flow|PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
10899637|NCT00562120|FG002|Participant Flow|Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
10899638|NCT00562120|FG003|Participant Flow|Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
10899639|NCT00562120|OG000|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
10899640|NCT00562120|OG001|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
10899641|NCT00562120|OG002|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
10899642|NCT00562120|OG003|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
10899643|NCT00562120|EG000|Reported Event|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
10899644|NCT00562120|EG001|Reported Event|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
10899645|NCT00562120|EG002|Reported Event|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
10899646|NCT00562120|EG003|Reported Event|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
10899647|NCT00562159|BG000|Baseline|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
10899648|NCT00562159|BG001|Baseline|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
10899649|NCT00562159|BG002|Baseline|Total|Total of all reporting groups
10899650|NCT00562159|FG000|Participant Flow|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
10899651|NCT00562159|FG001|Participant Flow|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
10899652|NCT00562159|OG000|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
10899653|NCT00562159|OG001|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
10899654|NCT00562159|OG001|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
10899655|NCT00562159|EG000|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
10899656|NCT00562159|EG001|Reported Event|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
10914820|NCT00632827|EG000|Reported Event|Treatment Plan|(1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days 1, 8, Navelbine 20 mg/m2 day 1, 8; Doxil 15 mg/m2 Days 1 and 8, G-CSF Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day -6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion day 0 (7) Post-transplant: Denileukin Diftitox (Ontak) 18 mcg/kg/day days 1- 5
10914821|NCT00632931|BG000|Baseline|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
11090786|NCT01531673|OG006|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090787|NCT01531673|OG007|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
11090788|NCT01531673|OG008|Outcome|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090789|NCT01531673|OG009|Outcome|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
11090790|NCT01531673|OG010|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090791|NCT01531673|OG011|Outcome|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090792|NCT01531673|OG012|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090793|NCT01531673|OG000|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
11090794|NCT01531673|OG001|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
11090795|NCT01531673|OG002|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090796|NCT01531673|OG003|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
11090797|NCT01531673|OG004|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090798|NCT01531673|OG005|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10899657|NCT00562302|BG000|Baseline|Bio-Seal Group|Bio-Seal Plug Implanted
10899658|NCT00562302|BG001|Baseline|Control Group|Control group with no intervention
10899659|NCT00562302|BG002|Baseline|Total|Total of all reporting groups
10899660|NCT00562302|FG000|Participant Flow|Bio-Seal Group|Bio-Seal Plug Implanted
10899661|NCT00562302|FG001|Participant Flow|Control Group|Control group with no intervention
10899662|NCT00562302|OG000|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
10899663|NCT00562302|OG001|Outcome|Control Group|Control group with no intervention
10899664|NCT00562302|EG000|Reported Event|Bio-Seal Group|Bio-Seal Plug Implanted
10899665|NCT00562302|EG001|Reported Event|Control Group|Control group with no intervention
10899666|NCT00562315|BG000|Baseline|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
10899667|NCT00562315|FG000|Participant Flow|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
10899668|NCT00562315|OG000|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
10899669|NCT00562315|OG000|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|"This is a single arm study~[18F]FACBC: [18F]FACBC is given intravenously prior to PET scan"
10899670|NCT00562315|OG000|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
10899671|NCT00562315|EG000|Reported Event|FACBC PET-CT and ProstaScint CT|All participants who received scans, including repeat scans, were monitored for adverse events.
10899672|NCT00562328|BG000|Baseline|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
10899673|NCT00562328|FG000|Participant Flow|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
10899674|NCT00562328|OG000|Outcome|Alemtuzumab + Rituximab + GM-CSF|Patients received Alemtuzumab + Rituximab + GM-CSF.
10899675|NCT00562328|EG000|Reported Event|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
10899676|NCT00562354|BG000|Baseline|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
10899677|NCT00562354|BG001|Baseline|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
10899678|NCT00562354|BG002|Baseline|Total|Total of all reporting groups
10899679|NCT00562354|FG000|Participant Flow|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
10899680|NCT00562354|FG001|Participant Flow|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
10899681|NCT00562354|OG000|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
10899682|NCT00562354|OG000|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
10899683|NCT00562354|OG001|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
10899684|NCT00562354|OG000|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
10914822|NCT00632931|FG000|Participant Flow|Vorinostat Then Placebo: Part 1|Single dose 800 mg vorinostat in Period 1 followed by a three day wash out period, then matching placebo in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
10914823|NCT00632931|FG001|Participant Flow|Placebo Then Vorinostat: Part 1|Single dose matching placebo in Period 1 followed by a three day wash out period, then single dose 800 mg vorinostat in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
10899685|NCT00562354|EG000|Reported Event|13vPnC (50 to 64 Years of Age)|"13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.~For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=80; systematic (solicited) Local Reactions N=120; systematic (solicited) Systemic Events N=112. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
10899686|NCT00562354|EG001|Reported Event|13vPnC (≥65 Years of Age)|"13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.~For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=77; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=116. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
10899687|NCT00562484|BG000|Baseline|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
10899688|NCT00562484|BG001|Baseline|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
10899689|NCT00562484|BG002|Baseline|Total|Total of all reporting groups
10899690|NCT00562484|FG000|Participant Flow|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
10899691|NCT00562484|FG001|Participant Flow|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
10899692|NCT00562484|OG000|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
10899693|NCT00562484|OG001|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
10899694|NCT00562484|EG000|Reported Event|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
10899695|NCT00562484|EG001|Reported Event|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
10899696|NCT00562588|BG000|Baseline|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
10899697|NCT00562588|BG001|Baseline|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
10899698|NCT00562588|BG002|Baseline|Total|Total of all reporting groups
10899699|NCT00562588|FG000|Participant Flow|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
10899700|NCT00562588|FG001|Participant Flow|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
11090799|NCT01531673|OG006|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
11090800|NCT01531673|OG007|Outcome|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090801|NCT01531673|OG008|Outcome|Group 1-5b Combined Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a and 5b who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
10899701|NCT00562588|OG000|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
10899702|NCT00562588|OG001|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
10899703|NCT00562588|EG000|Reported Event|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
10899704|NCT00562588|EG001|Reported Event|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
10899705|NCT00562627|BG000|Baseline|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
10899706|NCT00562627|BG001|Baseline|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
10899707|NCT00562627|BG002|Baseline|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
10899708|NCT00562627|BG003|Baseline|Total|Total of all reporting groups
10899709|NCT00562627|FG000|Participant Flow|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
10899710|NCT00562627|FG001|Participant Flow|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
10899711|NCT00562627|FG002|Participant Flow|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
10899712|NCT00562627|OG000|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
10899713|NCT00562627|OG001|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
10899714|NCT00562627|OG002|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
10899715|NCT00562627|EG000|Reported Event|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
10899716|NCT00562627|EG001|Reported Event|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
10899717|NCT00562627|EG002|Reported Event|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
10914824|NCT00632931|FG002|Participant Flow|All Participants: Part 2|"Vorinostat 400 mg once daily.~Ten participants changed dosage to vorinostat 300 mg daily during Part 2."
10914825|NCT00632931|OG000|Outcome|Vorinostat|
10899718|NCT00562718|BG000|Baseline|Surgery and Chemotherapy|"Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.~capecitabine~adjuvant therapy~radiation therapy"
10899719|NCT00562718|FG000|Participant Flow|Surgery and Chemotherapy|"Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.~capecitabine~adjuvant therapy~radiation therapy"
10899720|NCT00562718|OG000|Outcome|Surgery and Chemotherapy|"Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.~capecitabine~adjuvant therapy~radiation therapy"
10899721|NCT00562718|EG000|Reported Event|Surgery and Chemotherapy|"Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.~capecitabine~adjuvant therapy~radiation therapy"
10899722|NCT00562861|BG000|Baseline|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers.
10899723|NCT00562861|BG001|Baseline|Mood Stabilizer Plus Placebo|Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers
10899724|NCT00562861|BG002|Baseline|Total|Total of all reporting groups
10899725|NCT00562861|FG000|Participant Flow|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d.
10899726|NCT00562861|FG001|Participant Flow|Mood Stabilizer Plus Placebo|Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.
10899727|NCT00562861|OG000|Outcome|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
10899728|NCT00562861|OG001|Outcome|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
10899729|NCT00562861|EG000|Reported Event|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
10899730|NCT00562861|EG001|Reported Event|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
10899731|NCT00562965|BG000|Baseline|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
10899732|NCT00562965|BG001|Baseline|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
10899733|NCT00562965|BG002|Baseline|Total|Total of all reporting groups
10899734|NCT00562965|FG000|Participant Flow|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
10899735|NCT00562965|FG001|Participant Flow|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
10899736|NCT00562965|OG000|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
10899737|NCT00562965|OG001|Outcome|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
10899738|NCT00562965|EG000|Reported Event|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
10899739|NCT00562965|EG001|Reported Event|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
10914826|NCT00632931|OG001|Outcome|Placebo|
10914827|NCT00632931|EG000|Reported Event|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
10914828|NCT00632970|BG000|Baseline|Raltegravir|Raltegravir: 1 400mg tablet twice a day
10899740|NCT00562978|BG000|Baseline|Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg|"Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy.~Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation.~Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV~AHSCT: Patients undergo reinfusion of PBSCs.~Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity.~filgrastim~cyclophosphamide~etoposide~AHSCT~yttrium Y 90 ibritumomab tiuxetan"
10899741|NCT00562978|BG001|Baseline|Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg|"Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy.~Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation.~Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV~AHSCT: Patients undergo reinfusion of PBSCs.~Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity.~filgrastim~cyclophosphamide~etoposide~AHSCT~yttrium Y 90 ibritumomab tiuxetan"
10899742|NCT00562978|BG002|Baseline|Total|Total of all reporting groups
10899743|NCT00562978|FG000|Participant Flow|Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg|"Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy.~Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation.~Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV~AHSCT: Patients undergo reinfusion of PBSCs.~Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity.~filgrastim~cyclophosphamide~etoposide~AHSCT~yttrium Y 90 ibritumomab tiuxetan"
10899744|NCT00562978|FG001|Participant Flow|Zevalin 1000 cGy + VP-16 60 mg/kg +|"Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy.~Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation.~Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV~AHSCT: Patients undergo reinfusion of PBSCs.~Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity.~filgrastim~cyclophosphamide~etoposide~AHSCT~yttrium Y 90 ibritumomab tiuxetan"
10899745|NCT00562978|OG000|Outcome|Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg|Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 40 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
10899746|NCT00562978|OG001|Outcome|Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg|Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 60 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
10899747|NCT00562978|EG000|Reported Event|Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg|Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 40 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
10899748|NCT00562978|EG001|Reported Event|Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg|Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 60 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
10899749|NCT00563186|BG000|Baseline|Novel Hospital Ward Admission|Hospital admission to a ward with novel infection control design features (e.g. abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms)
10899750|NCT00563186|BG001|Baseline|Traditional Hospital Ward Admission|Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
10899751|NCT00563186|BG002|Baseline|Total|Total of all reporting groups
10899752|NCT00563186|FG000|Participant Flow|Novel Hospital Ward Admission|Hospital admission to a ward with novel infection control design features (e.g. abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms)
10899753|NCT00563186|FG001|Participant Flow|Traditional Hospital Ward Admission|Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
10899754|NCT00563186|OG000|Outcome|Novel Hospital Ward Admission|Hospital admission to a ward with novel infection control design features (e.g. abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms)
10899755|NCT00563186|OG001|Outcome|Traditional Hospital Ward Admission|Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
10899756|NCT00563186|OG000|Outcome|Novel and Traditional Hospital Ward Admission|Number of MRSA, VRE and CDI cases occurring in single-and multiple-bed rooms in Novel Hospital Ward and Traditional Hospital Ward during outbreaks
10899757|NCT00563186|OG000|Outcome|Incidence Density in Single-bed Rooms|# MRSA, VRE and CDI (expressed per 1000 pt days)occurring in single-bed rooms on the novel design ward
10899758|NCT00563186|OG001|Outcome|Incidence Density in Multi-bed Rooms|# MRSA, VRE and CDI (expressed per 1000 pt days)occurring in multi-bed rooms on the novel design ward
10914829|NCT00632970|BG001|Baseline|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
10899759|NCT00563186|EG000|Reported Event|Novel Hospital Ward Admission|Hospital admission to a ward with novel infection control design features (e.g. abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms)
10899760|NCT00563186|EG001|Reported Event|Traditional Hospital Ward Admission|Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
10899761|NCT00563290|BG000|Baseline|Arm I Dasatinib|Patients receive oral dasatinib 100 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10899762|NCT00563290|BG001|Baseline|Arm II Dastinib|Patients receive oral dasatinib 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10899763|NCT00563290|BG002|Baseline|Total|Total of all reporting groups
10899764|NCT00563290|FG000|Participant Flow|Arm I Dasatinib|Patients receive 100 mg orally twice a day.
10899765|NCT00563290|FG001|Participant Flow|Arm II Dasatinib|Patients receive 70 mg dasatinib PO BID on days 1-28
10899766|NCT00563290|OG000|Outcome|Arm I: Dasatinib|Patients receive 100 mg orally twice a day.
10899767|NCT00563290|OG001|Outcome|Arm II: Dasatinib|Patients receive 70 mg orally twice a day.
10899768|NCT00563290|OG000|Outcome|Arm I and Arm II|"For Arm I patients receive Dasatinib100 mg orally twice a day.~For Arm II patients receive Dasatinib 70 mg orally twice a day."
10899769|NCT00563290|OG000|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
10899770|NCT00563290|EG000|Reported Event|Dasatinib 100 mg|Patients receive the initial dose of 100 mg orally twice a day.
10899771|NCT00563290|EG001|Reported Event|Dasatinib 70 mg|Patients receive the initial dose of 70 mg orally twice a day. Dose was reduced to 70 mg orally based on toxicity.
10899772|NCT00563316|BG000|Baseline|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
10899773|NCT00563316|FG000|Participant Flow|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
10899774|NCT00563316|OG000|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
10899775|NCT00563316|OG001|Outcome|Treatment Phase 1|Cycle 1 Irinotecan - After irinotecan administration, but before panitumumab administration.
10899776|NCT00563316|OG002|Outcome|Treatment Phase 2|Cycle 1 Irinotecan and Panitumumab - After first panitumumab administration until the start of Cycle 2.
10899777|NCT00563316|OG003|Outcome|Treatment Phase 3|Cycle 2 Irinotecan and Panitumumab - After irinotecan administration until 72 hours after administration.
10899778|NCT00563316|OG004|Outcome|Treatment Phase 4|All Other - 72 hours after administration of irinotecan in Cycle 2 until end of study.
10899779|NCT00563316|EG000|Reported Event|Panitumumab With Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
10899780|NCT00563368|BG000|Baseline|Placebo|Placebo
10899781|NCT00563368|BG001|Baseline|PHEN 7.5 mg|7.5 mg phentermine
10899782|NCT00563368|BG002|Baseline|TPM 46 mg|46 mg topiramate
10899783|NCT00563368|BG003|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
10899784|NCT00563368|BG004|Baseline|PHEN 15 mg|15 mg phentermine
10899785|NCT00563368|BG005|Baseline|TPM 92 mg|92 mg topiramate
10899786|NCT00563368|BG006|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
10899787|NCT00563368|BG007|Baseline|Total|Total of all reporting groups
10899788|NCT00563368|FG000|Participant Flow|Placebo|Placebo
11090802|NCT01531673|OG000|Outcome|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
10899789|NCT00563368|FG001|Participant Flow|PHEN 7.5 mg|7.5 mg phentermine
10899790|NCT00563368|FG002|Participant Flow|TPM 46 mg|46 mg topiramate
10899791|NCT00563368|FG003|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
10899792|NCT00563368|FG004|Participant Flow|PHEN 15 mg|15 mg phentermine
10899793|NCT00563368|FG005|Participant Flow|TPM 92 mg|92 mg topiramate
10899794|NCT00563368|FG006|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
10899795|NCT00563368|OG000|Outcome|Placebo|Placebo
10899796|NCT00563368|OG001|Outcome|PHEN 7.5 mg|7.5 mg phentermine
10899797|NCT00563368|OG002|Outcome|TPM 46 mg|46 mg topiramate
10899798|NCT00563368|OG003|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
10899799|NCT00563368|OG004|Outcome|PHEN 15 mg|15 mg phentermine
10899800|NCT00563368|OG005|Outcome|TPM 92 mg|92 mg topiramate
10899801|NCT00563368|OG006|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
10899802|NCT00563368|EG000|Reported Event|Placebo|Placebo
10899803|NCT00563368|EG001|Reported Event|PHEN 7.5 mg|7.5 mg phentermine
10899804|NCT00563368|EG002|Reported Event|TPM 46 mg|46 mg topiramate
10899805|NCT00563368|EG003|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
10899806|NCT00563368|EG004|Reported Event|PHEN 15 mg|15 mg phentermine
10899807|NCT00563368|EG005|Reported Event|TPM 92 mg|92 mg topiramate
10899808|NCT00563368|EG006|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
10899809|NCT00563381|BG000|Baseline|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
10899810|NCT00563381|BG001|Baseline|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
10899811|NCT00563381|BG002|Baseline|Total|Total of all reporting groups
10914830|NCT00632970|BG002|Baseline|Total|Total of all reporting groups
10899812|NCT00563381|FG000|Participant Flow|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
10899813|NCT00563381|FG001|Participant Flow|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
10899814|NCT00563381|OG000|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
10899815|NCT00563381|OG001|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
10899816|NCT00563381|EG000|Reported Event|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
10899817|NCT00563381|EG001|Reported Event|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
10899818|NCT00563706|BG000|Baseline|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899819|NCT00563706|BG001|Baseline|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899820|NCT00563706|BG002|Baseline|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899821|NCT00563706|BG003|Baseline|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899822|NCT00563706|BG004|Baseline|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
10899823|NCT00563706|BG005|Baseline|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
10899824|NCT00563706|BG006|Baseline|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
10899825|NCT00563706|BG007|Baseline|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
10899826|NCT00563706|BG008|Baseline|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
10899827|NCT00563706|BG009|Baseline|Total|Total of all reporting groups
10899828|NCT00563706|FG000|Participant Flow|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899829|NCT00563706|FG001|Participant Flow|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899830|NCT00563706|FG002|Participant Flow|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899831|NCT00563706|FG003|Participant Flow|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10914831|NCT00632970|FG000|Participant Flow|Raltegravir|Patients with HIV infection randomized to receive raltegravir with truvada
10914832|NCT00632970|FG001|Participant Flow|Lopinavir/Ritonavir|Patients with HIV infection randomized to receive lopinavir/ritonavir with truvada
11090803|NCT01531673|OG001|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet q12h and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10899832|NCT00563706|FG004|Participant Flow|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
10899833|NCT00563706|FG005|Participant Flow|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
10899834|NCT00563706|FG006|Participant Flow|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
10899835|NCT00563706|FG007|Participant Flow|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
10899836|NCT00563706|FG008|Participant Flow|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
10899837|NCT00563706|OG000|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899838|NCT00563706|OG001|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899839|NCT00563706|OG002|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899840|NCT00563706|OG003|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899841|NCT00563706|OG004|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
10899842|NCT00563706|OG005|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
10899843|NCT00563706|OG006|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
10899844|NCT00563706|OG007|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
10899845|NCT00563706|OG008|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
10899846|NCT00563706|EG000|Reported Event|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899847|NCT00563706|EG001|Reported Event|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10914833|NCT00632970|OG000|Outcome|Raltegravir|Raltegravir: 1 400mg tablet twice a day
10899848|NCT00563706|EG002|Reported Event|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899849|NCT00563706|EG003|Reported Event|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
10899850|NCT00563706|EG004|Reported Event|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
10899851|NCT00563706|EG005|Reported Event|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
10899852|NCT00563706|EG006|Reported Event|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
10899853|NCT00563706|EG007|Reported Event|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
10899854|NCT00563706|EG008|Reported Event|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
10899855|NCT00563784|BG000|Baseline|Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA|TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
10899856|NCT00563784|FG000|Participant Flow|Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA|TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
10899857|NCT00563784|OG000|Outcome|Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA|TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
10899858|NCT00563784|EG000|Reported Event|Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA|TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
10899859|NCT00563797|BG000|Baseline|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
10899860|NCT00563797|BG001|Baseline|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
10899861|NCT00563797|BG002|Baseline|Total|Total of all reporting groups
10899862|NCT00563797|FG000|Participant Flow|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
10899863|NCT00563797|FG001|Participant Flow|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
10899864|NCT00563797|OG000|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
10899865|NCT00563797|OG001|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
10899866|NCT00563797|OG000|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
10899867|NCT00563797|OG001|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
10899868|NCT00563797|EG000|Reported Event|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
10899869|NCT00563797|EG001|Reported Event|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to themedication capsules.~Placebo: Placebo pill"
10899870|NCT00564018|BG000|Baseline|Detemir|Subjects randomized to treatment with insulins detemir and aspart
10899871|NCT00564018|BG001|Baseline|Isophane (NPH) Insulin|Subjects randomized to treatment with insulins NPH and aspart
10899872|NCT00564018|BG002|Baseline|Glargine|Subjects randomized to treatment with insulins glargine and aspart
10899873|NCT00564018|BG003|Baseline|Total|Total of all reporting groups
10899874|NCT00564018|FG000|Participant Flow|Detemir|Subjects randomized to treatment with insulins detemir and aspart
10899875|NCT00564018|FG001|Participant Flow|NPH Insulin|Subjects randomized to treatment with insulins NPH and aspart
10899876|NCT00564018|FG002|Participant Flow|Glargine|Subjects randomized to treatment with insulins glargine and aspart
10899877|NCT00564018|OG000|Outcome|Detemir|Subjects randomized to treatment with insulins detemir and aspart
10899878|NCT00564018|OG001|Outcome|NPH Insulin|Subjects randomized to treatment with insulins NPH and aspart
10899879|NCT00564018|OG002|Outcome|Glargine|Subjects randomized to treatment with insulins glargine and aspart
10899880|NCT00564018|EG000|Reported Event|Detemir|Subjects randomized to treatment with insulins detemir and aspart
10899881|NCT00564018|EG001|Reported Event|NPH Insulin|Subjects randomized to treatment with insulins NPH and aspart
10899882|NCT00564018|EG002|Reported Event|Glargine|Subjects randomized to treatment with insulins glargine and aspart
10899883|NCT00564070|BG000|Baseline|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
10899884|NCT00564070|BG001|Baseline|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
10899885|NCT00564070|BG002|Baseline|Total|Total of all reporting groups
10899886|NCT00564070|FG000|Participant Flow|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
11090804|NCT01531673|OG002|Outcome|Group 4 and 6 Combined: Placebo|All participants in group 4, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
10899887|NCT00564070|FG001|Participant Flow|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
10899888|NCT00564070|OG000|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
10899889|NCT00564070|OG001|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
10899890|NCT00564070|EG000|Reported Event|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
10899891|NCT00564070|EG001|Reported Event|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
10899892|NCT00564265|BG000|Baseline|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
10899893|NCT00564265|FG000|Participant Flow|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
10899894|NCT00564265|OG000|Outcome|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
10899895|NCT00564265|EG000|Reported Event|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
10899896|NCT00564278|BG000|Baseline|Standard Medication Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 43.4 with SD=13.2.
10899897|NCT00564278|BG001|Baseline|Motivational Pharmacotherapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 44.1 with SD=12.3.
10899898|NCT00564278|BG002|Baseline|Total|Total of all reporting groups
10899899|NCT00564278|FG000|Participant Flow|Standard Antidepressant Therapy|As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).
10914834|NCT00632970|OG001|Outcome|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
10914835|NCT00632970|EG000|Reported Event|Raltegravir|Raltegravir: 1 400mg tablet twice a day
10899900|NCT00564278|FG001|Participant Flow|Motivational Antidepressant Therapy|As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).
10899901|NCT00564278|OG000|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
10899902|NCT00564278|OG001|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
10899903|NCT00564278|EG000|Reported Event|Standard Antidepressant Therapy|Participants will receive standard antidepressant therapy. Standard antidepressant therapy (SADT): Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
10899904|NCT00564278|EG001|Reported Event|Motivational Antidepressant Therapy|Participants will receive motivational antidepressant therapy. Motivational antidepressant therapy (MADT): The same medication treatment for depression will be offered as in the SADT arm and supplemented with techniques from motivational interviewing.
10899905|NCT00564395|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Insulin Detemir mixed with RAI subcutaneous injection twice daily or Insulin Detemir and RAI as separate subcutaneous injections, twice daily
10899906|NCT00564395|FG000|Participant Flow|Insulin Detemir+RAI, Then Insulin Detemir and RAI Separately|Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days.
10899907|NCT00564395|FG001|Participant Flow|Insulin Detemir and RAI Separately, Then Insulin Detemir+RAI|Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days
10899908|NCT00564395|OG000|Outcome|Insulin Detemir Mixed With RAI Injection|Participants who received Insulin Detemir mixed with RAI injection, twice daily as subcutaneous injection in either the first or last 10 days of the study.
10899909|NCT00564395|OG001|Outcome|Insulin Detemir and RAI Injection Separately|Participants who received Insulin Detemir and RAI as separate subcutaneous injections, twice daily in either the first or last 10 days of the study.
10899910|NCT00564395|EG000|Reported Event|Insulin Detemir Mixed With RAI Injection|Participants who received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days.
10899911|NCT00564395|EG001|Reported Event|Insulin Detemir and RAI Injection Separately|Participants who received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days.
10899912|NCT00564447|BG000|Baseline|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
10899913|NCT00564447|BG001|Baseline|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
10899914|NCT00564447|BG002|Baseline|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
10899915|NCT00564447|BG003|Baseline|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
10899916|NCT00564447|BG004|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
10899917|NCT00564447|BG005|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
10899918|NCT00564447|BG006|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
10899919|NCT00564447|BG007|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
10899920|NCT00564447|BG008|Baseline|Total|Total of all reporting groups
10899921|NCT00564447|FG000|Participant Flow|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
10899922|NCT00564447|FG001|Participant Flow|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
10899923|NCT00564447|FG002|Participant Flow|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
10899924|NCT00564447|FG003|Participant Flow|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
10899925|NCT00564447|FG004|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
10899926|NCT00564447|FG005|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
10899927|NCT00564447|FG006|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
10899928|NCT00564447|FG007|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
10899929|NCT00564447|OG000|Outcome|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
10899930|NCT00564447|OG001|Outcome|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
10899931|NCT00564447|OG002|Outcome|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
10899932|NCT00564447|OG003|Outcome|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
10899933|NCT00564447|OG004|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
10899934|NCT00564447|OG005|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
10899935|NCT00564447|OG006|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
10899936|NCT00564447|OG007|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
10899937|NCT00564447|EG000|Reported Event|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
10899938|NCT00564447|EG001|Reported Event|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
10899939|NCT00564447|EG002|Reported Event|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
10899940|NCT00564447|EG003|Reported Event|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
10899941|NCT00564447|EG004|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
10899942|NCT00564447|EG005|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
10899943|NCT00564447|EG006|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
10899944|NCT00564447|EG007|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
10899945|NCT00564486|BG000|Baseline|IV Placebo|All subjects randomized to receive IV Placebo 100 ml and IV placebo 65 ml groups combined
10899946|NCT00564486|BG001|Baseline|IV Acetaminophen 1 gm|All subjects randomized to receive IV Acetaminophen 1 gm
10899947|NCT00564486|BG002|Baseline|IV Acetaminophen 650 mg|All subjects randomized to receive IV Acetaminophen 650 mg
10899948|NCT00564486|BG003|Baseline|Total|Total of all reporting groups
10899949|NCT00564486|FG000|Participant Flow|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
10899950|NCT00564486|FG001|Participant Flow|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
10899951|NCT00564486|FG002|Participant Flow|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
10899952|NCT00564486|FG003|Participant Flow|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
10899953|NCT00564486|OG000|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
10899954|NCT00564486|OG001|Outcome|IV Acetaminophen 1 gm|mITT - IV Acetaminophen 1 gm
10899955|NCT00564486|OG001|Outcome|IV Acetaminophen 650 mg|mITT - IV Acetaminophen 650 mg
10899956|NCT00564486|OG000|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
10899957|NCT00564486|OG001|Outcome|IV Acetaminophen 1000 mg|IV Acetaminophen 1000 mg every 6 hours for 24 hours
10899958|NCT00564486|OG002|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours
10899959|NCT00564486|OG001|Outcome|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm every 6 hours for 24 hours (4 doses total)
10899960|NCT00564486|OG002|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours (6 doses total)
10899961|NCT00564486|EG000|Reported Event|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
10899962|NCT00564486|EG001|Reported Event|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
10899963|NCT00564486|EG002|Reported Event|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
10899964|NCT00564486|EG003|Reported Event|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
10899965|NCT00564629|BG000|Baseline|PO APAP 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen and 100 ml of intravenous placebo solution as the study treatment
10899966|NCT00564629|BG001|Baseline|IV APAP 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g of acetaminophen in 100 ml of intravenous solution and oral placebo as the study treatment
10899967|NCT00564629|BG002|Baseline|Total|Total of all reporting groups
10899968|NCT00564629|FG000|Participant Flow|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
10899969|NCT00564629|FG001|Participant Flow|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
10899970|NCT00564629|OG000|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
10899971|NCT00564629|OG001|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
10899972|NCT00564629|EG000|Reported Event|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
10899973|NCT00564629|EG001|Reported Event|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
10899974|NCT00564681|BG000|Baseline|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
10899975|NCT00564681|BG001|Baseline|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
10899976|NCT00564681|BG002|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
10899977|NCT00564681|BG003|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
10899978|NCT00564681|BG004|Baseline|Total|Total of all reporting groups
10899979|NCT00564681|FG000|Participant Flow|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
10899980|NCT00564681|FG001|Participant Flow|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
10899981|NCT00564681|FG002|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
10899982|NCT00564681|FG003|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
10899983|NCT00564681|OG000|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
10899984|NCT00564681|OG001|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
10899985|NCT00564681|OG002|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
10899986|NCT00564681|EG000|Reported Event|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
10899987|NCT00564681|EG001|Reported Event|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
10899988|NCT00564681|EG002|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
10899989|NCT00564681|EG003|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
10899990|NCT00564733|BG000|Baseline|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
10899991|NCT00564733|FG000|Participant Flow|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
10899992|NCT00564733|OG000|Outcome|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
10899993|NCT00564733|EG000|Reported Event|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
10899994|NCT00564850|BG000|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
10899995|NCT00564850|FG000|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
10899996|NCT00564850|OG000|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
10899997|NCT00564850|EG000|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
11171786|NCT02005276|OG003|Outcome|Combined Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 5 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day.~Combined Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day."
11171787|NCT02005276|OG002|Outcome|Combined Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 5 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day.~Combined Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day."
10899998|NCT00564889|BG000|Baseline|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
10899999|NCT00564889|FG000|Participant Flow|Len/Cyc/Dex|"Lenalidomide (Len) 15mg daily (days 1-21)~Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15)~Dexamethasone (Dex) 40 mg weekly"
10900000|NCT00564889|OG000|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
10900001|NCT00564889|EG000|Reported Event|Len/Cyc/Dex|Dexamethasone (Dex) 40 mg weekly
10900002|NCT00564902|BG000|Baseline|Lutein|Lutein 9 mg per day
10900003|NCT00564902|BG001|Baseline|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
10900004|NCT00564902|BG002|Baseline|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
10900005|NCT00564902|BG003|Baseline|Total|Total of all reporting groups
10900006|NCT00564902|FG000|Participant Flow|Lutein|Lutein 9 mg per day
10900007|NCT00564902|FG001|Participant Flow|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
10900008|NCT00564902|FG002|Participant Flow|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
10900009|NCT00564902|OG000|Outcome|Lutein|Lutein 9 mg per day
10900010|NCT00564902|OG001|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
10900011|NCT00564902|OG002|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
10900012|NCT00564902|EG000|Reported Event|Lutein|Lutein 9 mg per day
10900013|NCT00564902|EG001|Reported Event|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
10900014|NCT00564902|EG002|Reported Event|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
10900015|NCT00564954|BG000|Baseline|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
10900016|NCT00564954|BG001|Baseline|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
10900017|NCT00564954|BG002|Baseline|Total|Total of all reporting groups
10900018|NCT00564954|FG000|Participant Flow|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
10900019|NCT00564954|FG001|Participant Flow|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
10900020|NCT00564954|OG000|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
10900021|NCT00564954|OG001|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
10900022|NCT00564954|EG000|Reported Event|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
10900023|NCT00564954|EG001|Reported Event|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
10900024|NCT00565045|BG000|Baseline|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
10900025|NCT00565045|BG001|Baseline|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
10900026|NCT00565045|BG002|Baseline|Total|Total of all reporting groups
10900027|NCT00565045|FG000|Participant Flow|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
10900028|NCT00565045|FG001|Participant Flow|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
10900029|NCT00565045|OG000|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
10914836|NCT00632970|EG001|Reported Event|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
11090805|NCT01531673|OG000|Outcome|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090806|NCT01531673|OG001|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090807|NCT01531673|OG001|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10900030|NCT00565045|OG001|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
10900031|NCT00565045|EG000|Reported Event|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
10900032|NCT00565045|EG001|Reported Event|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
10900033|NCT00565058|BG000|Baseline|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
10900034|NCT00565058|BG001|Baseline|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
10900035|NCT00565058|BG002|Baseline|Total|Total of all reporting groups
10900036|NCT00565058|FG000|Participant Flow|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
10900037|NCT00565058|FG001|Participant Flow|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
10900038|NCT00565058|OG000|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
10900039|NCT00565058|OG001|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
10900040|NCT00565058|EG000|Reported Event|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
10900041|NCT00565058|EG001|Reported Event|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
10900042|NCT00565084|BG000|Baseline|Overall Study|
10900043|NCT00565084|FG000|Participant Flow|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
10900044|NCT00565084|FG001|Participant Flow|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
10900045|NCT00565084|FG002|Participant Flow|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
10900046|NCT00565084|OG000|Outcome|Ibuprofen|Single dose ibuprofen 800 mg
10900047|NCT00565084|OG001|Outcome|Placebo 1|First Single dose placebo
10900048|NCT00565084|OG002|Outcome|Placebo 2|Second Single dose placebo
10900049|NCT00565084|EG000|Reported Event|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
10900050|NCT00565084|EG001|Reported Event|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
10900051|NCT00565084|EG002|Reported Event|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
10900052|NCT00565110|BG000|Baseline|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
10900053|NCT00565110|BG001|Baseline|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
10900054|NCT00565110|BG002|Baseline|Total|Total of all reporting groups
10900055|NCT00565110|FG000|Participant Flow|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
10914837|NCT00633009|BG000|Baseline|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
11090808|NCT01531673|OG002|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
11090809|NCT01531673|OG003|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
10900056|NCT00565110|FG001|Participant Flow|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
10900057|NCT00565110|OG000|Outcome|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
10900058|NCT00565110|OG001|Outcome|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
10900059|NCT00565110|EG000|Reported Event|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
10914838|NCT00633009|BG001|Baseline|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
11171788|NCT02005276|OG003|Outcome|Jackpot Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day.~Jackpot Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day."
11171789|NCT02005276|EG000|Reported Event|Control|Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day.
11171790|NCT02005276|EG001|Reported Event|Basic Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day.~Basic Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day."
11171791|NCT02005276|EG002|Reported Event|Jackpot Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day.~Jackpot Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day."
11171792|NCT02005276|EG003|Reported Event|Combined Lottery|"Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:~About a 1 in 5 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day.~Combined Lottery: Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day."
11171793|NCT02005354|BG000|Baseline|TENS Intervention|"The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a strong but comfortable sensation. From previous studies, this is likely to be 50-110Hz.~The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study.~All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)"
10900060|NCT00565110|EG001|Reported Event|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
10900061|NCT00565136|BG000|Baseline|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
10900062|NCT00565136|FG000|Participant Flow|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
10900063|NCT00565136|OG000|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
10900064|NCT00565136|EG000|Reported Event|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
10900065|NCT00565266|BG000|Baseline|All Participants|All participants randomized into the six-sequence crossover study
10900066|NCT00565266|FG000|Participant Flow|All Participants|"All participants randomized into the six-sequence crossover study. All TALC participants underwent three 16-week treatment periods:~tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)~salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)~beclomethasone dipropionate 160 mcg twice daily (2xICS)"
10900067|NCT00565266|OG000|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
10900068|NCT00565266|OG001|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
10900069|NCT00565266|OG002|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
10900070|NCT00565266|EG000|Reported Event|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
10900071|NCT00565266|EG001|Reported Event|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
10900072|NCT00565266|EG002|Reported Event|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
10900073|NCT00565370|BG000|Baseline|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
10900074|NCT00565370|FG000|Participant Flow|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib Level 1 sorafenib 400 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 2 sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 3 sorafenib 800 mg/d, capecitabine 2,000 mg/m2/d, cisplatin 80 mg/m2 Level 1A sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 60 mg/m2
10900075|NCT00565370|OG000|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
10900076|NCT00565370|EG000|Reported Event|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
10900077|NCT00565409|BG000|Baseline|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
10900078|NCT00565409|FG000|Participant Flow|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
11090810|NCT01531673|OG000|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10900079|NCT00565409|FG001|Participant Flow|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
10900080|NCT00565409|FG002|Participant Flow|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
10900081|NCT00565409|FG003|Participant Flow|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
11090811|NCT01531673|OG001|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090812|NCT01531673|OG002|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090813|NCT01531673|OG003|Outcome|Group 5b: VX-661 150 mg qd/ Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
10900082|NCT00565409|OG000|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
10900083|NCT00565409|OG001|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
10900084|NCT00565409|OG002|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
10900085|NCT00565409|OG000|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
10900086|NCT00565409|EG000|Reported Event|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
10900087|NCT00565409|EG001|Reported Event|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
10900088|NCT00565409|EG002|Reported Event|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
10900089|NCT00565409|EG003|Reported Event|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
10900090|NCT00565448|BG000|Baseline|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
10900091|NCT00565448|BG001|Baseline|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
10900092|NCT00565448|BG002|Baseline|Total|Total of all reporting groups
10900093|NCT00565448|FG000|Participant Flow|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
10900094|NCT00565448|FG001|Participant Flow|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
10900095|NCT00565448|OG000|Outcome|Docetaxel /Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
11090814|NCT01531673|OG004|Outcome|Group 6a: VX-661 100 mg qd/ Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
11090815|NCT01531673|OG005|Outcome|Group 6d: VX-661 50 mg q12h/ Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090816|NCT01531673|OG006|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician prescribed Kalydeco for up to 28 days.
11090817|NCT01531673|EG000|Reported Event|Group 1-6d Combined: Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
11090818|NCT01531673|EG001|Reported Event|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 milligram (mg) tablet orally qd for up to 28 days.
11090819|NCT01531673|EG002|Reported Event|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
10900096|NCT00565448|OG001|Outcome|Cisplatin/5-FU|Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
10900097|NCT00565448|OG000|Outcome|Docetaxel/Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
11090820|NCT01531673|EG003|Reported Event|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090821|NCT01531673|EG004|Reported Event|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
11090822|NCT01531673|EG005|Reported Event|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090823|NCT01531673|EG006|Reported Event|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090824|NCT01531673|EG007|Reported Event|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
11090825|NCT01531673|EG008|Reported Event|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090826|NCT01531673|EG009|Reported Event|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
11090827|NCT01531673|EG010|Reported Event|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
11090828|NCT01531673|EG011|Reported Event|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090829|NCT01531673|EG012|Reported Event|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
11090830|NCT01531725|BG000|Baseline|BMS Implantation|Patients with a BMS implanted.
11090831|NCT01531725|FG000|Participant Flow|BMS Implantation|BMS implantation
11090832|NCT01531725|OG000|Outcome|BMS Implantation|BMS implantation
11090833|NCT01531725|EG000|Reported Event|BMS Implantation|BMS implantation
11090834|NCT01531738|BG000|Baseline|Control|Normal weight healthy volunteers
11090835|NCT01531738|BG001|Baseline|Bariatric Surgery|obese patients due to undergo gastric bypass or gastric banding
11090836|NCT01531738|BG002|Baseline|Total|Total of all reporting groups
10900098|NCT00565448|OG000|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
10900099|NCT00565448|OG001|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
10900100|NCT00565448|EG000|Reported Event|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
10900101|NCT00565448|EG001|Reported Event|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
10900102|NCT00565604|BG000|Baseline|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
10900103|NCT00565604|FG000|Participant Flow|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
10900104|NCT00565604|OG000|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
10900105|NCT00565604|EG000|Reported Event|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
10900106|NCT00565643|BG000|Baseline|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
10900107|NCT00565643|BG001|Baseline|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
10900108|NCT00565643|BG002|Baseline|Total|Total of all reporting groups
10900109|NCT00565643|FG000|Participant Flow|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
10900110|NCT00565643|FG001|Participant Flow|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
10900111|NCT00565643|OG000|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
10900112|NCT00565643|OG001|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
10900113|NCT00565643|OG000|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
10900114|NCT00565643|EG000|Reported Event|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
10900115|NCT00565643|EG001|Reported Event|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
10900116|NCT00565669|BG000|Baseline|Blink Tears|
10900117|NCT00565669|BG001|Baseline|Systane|
10900118|NCT00565669|BG002|Baseline|Total|Total of all reporting groups
10900119|NCT00565669|FG000|Participant Flow|Blink Tears|
10900120|NCT00565669|FG001|Participant Flow|Systane|
10900121|NCT00565669|OG000|Outcome|Blink Tears|
10900122|NCT00565669|OG001|Outcome|Systane|
10900123|NCT00565669|EG000|Reported Event|Blink Years|
10900124|NCT00565669|EG001|Reported Event|Systane|
10900125|NCT00565721|BG000|Baseline|Safety With Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
10900126|NCT00565721|FG000|Participant Flow|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
10900127|NCT00565721|OG000|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
10900128|NCT00565721|OG000|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
10900129|NCT00565721|OG000|Outcome|Correlation Between Ki_inp-Patlak αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Full Analysis Set (FAS) subjects.
10900130|NCT00565721|OG000|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
10900131|NCT00565721|OG000|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
10900132|NCT00565721|OG000|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
10900133|NCT00565721|OG000|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
10900134|NCT00565721|OG000|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
11090837|NCT01531738|FG000|Participant Flow|Control|Normal weight healthy volunteers
10900135|NCT00565721|OG000|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
10900136|NCT00565721|OG000|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
10900137|NCT00565721|OG000|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
10900138|NCT00565721|OG000|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
10900139|NCT00565721|OG000|Outcome|Correlation Between Ki_inp-Patlak and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
10900140|NCT00565721|OG000|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
10900141|NCT00565721|OG000|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
10900142|NCT00565721|OG000|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
10900143|NCT00565721|EG000|Reported Event|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
10900144|NCT00565747|BG000|Baseline|Test Culture|Culture with 2 ng/ml GM-CSF
10900145|NCT00565747|BG001|Baseline|Control Culture|Culture without GM-CSF
10900146|NCT00565747|BG002|Baseline|Total|Total of all reporting groups
10900147|NCT00565747|FG000|Participant Flow|Test Culture|Culture with 2 ng/ml GM-CSF
10900148|NCT00565747|FG001|Participant Flow|Control Culture|Culture without GM-CSF
10900149|NCT00565747|OG000|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
10900150|NCT00565747|OG001|Outcome|Control Culture|Culture without GM-CSF
10900151|NCT00565747|EG000|Reported Event|Test Culture|Culture with 2 ng/ml GM-CSF
10900152|NCT00565747|EG001|Reported Event|Control Culture|Culture without GM-CSF
10900153|NCT00565773|BG000|Baseline|Immunosuppresive Medication Combination|Renal transplant recipients receiving an experimental combination of immunosuppressive medications. Participants received a single dose of alemtuzumab on the day of transplantation and receive belatacept and sirolimus for one year.
10900154|NCT00565773|FG000|Participant Flow|Immunosuppresive Medication Combination|Renal transplant recipients receiving an experimental combination of immunosuppressive medications. Participants received a single dose of alemtuzumab on the day of transplantation and receive belatacept and sirolimus for one year.
10900155|NCT00565773|OG000|Outcome|Immunosuppresive Medication Combination|Renal transplant recipients receiving an experimental combination of immunosuppressive medications. Participants received a single dose of alemtuzumab on the day of transplantation and receive belatacept and sirolimus for one year.
10900156|NCT00565773|EG000|Reported Event|Immunosuppresive Medication Combination|Renal transplant recipients receiving an experimental combination of immunosuppressive medications. Participants received a single dose of alemtuzumab on the day of transplantation and receive belatacept and sirolimus for one year.
10900157|NCT00565812|BG000|Baseline|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
10900158|NCT00565812|BG001|Baseline|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
10900159|NCT00565812|BG002|Baseline|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
10900160|NCT00565812|BG003|Baseline|Total|Total of all reporting groups
10900161|NCT00565812|FG000|Participant Flow|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
10900162|NCT00565812|FG001|Participant Flow|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
10900163|NCT00565812|FG002|Participant Flow|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
10900164|NCT00565812|OG000|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
10900165|NCT00565812|OG001|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
10900166|NCT00565812|OG002|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
10900167|NCT00565812|EG000|Reported Event|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
10900168|NCT00565812|EG001|Reported Event|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
10900169|NCT00565812|EG002|Reported Event|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
10900170|NCT00565864|BG000|Baseline|Arm 1|Normal baseline TSH Target TSH 0.28 - 2.50 mU/L
10900171|NCT00565864|BG001|Baseline|Arm 2|Normal baseline TSH target TSH 2.51 - 5.60 mU/L
10900172|NCT00565864|BG002|Baseline|Arm 3|Normal baseline TSH target TSH 5.61 - 12.0 mU/L
10900173|NCT00565864|BG003|Baseline|Total|Total of all reporting groups
10900174|NCT00565864|FG000|Participant Flow|Arm 1|Normal baseline thyroid stimulating hormone (TSH) Target TSH 0.28 - 2.50 milliunits/liter (mU/L)
10900175|NCT00565864|FG001|Participant Flow|Arm 2|Normal baseline thyroid stimulating hormone (TSH) target TSH 2.51 - 5.60 milliunits/liter (mU/L)
10900176|NCT00565864|FG002|Participant Flow|Arm 3|Normal baseline thyroid stimulating hormone (TSH) target TSH 5.61 - 12.0 milliunits/liter (mU/L)
10900177|NCT00565864|OG000|Outcome|Arm 1|Normal baseline TSH Target TSH 0.28 - 2.50 mU/L
10900178|NCT00565864|OG001|Outcome|Arm 2|Normal baseline TSH target TSH 2.51 - 5.60 mU/L
10900179|NCT00565864|OG002|Outcome|Arm 3|Normal baseline TSH target TSH 5.61 - 12.0 mU/L
10900180|NCT00565864|OG000|Outcome|Arm 2|Normal baseline TSH target TSH 2.51 - 5.60 mU/L
10900181|NCT00565864|OG001|Outcome|Arm 1|Normal baseline TSH Target TSH 0.28 - 2.50 mU/L
10900182|NCT00565864|EG000|Reported Event|Arm 1|Normal baseline TSH Target TSH 0.28 - 2.50 mU/L
10900183|NCT00565864|EG001|Reported Event|Arm 2|Normal baseline TSH target TSH 2.51 - 5.60 mU/L
10900184|NCT00565864|EG002|Reported Event|Arm 3|Normal baseline TSH target TSH 5.61 - 12.0 mU/L
10900185|NCT00565916|BG000|Baseline|Estrogen Plus Progesterone|"Hormone replacement therapy (HRT): estrogen plus progesterone~Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).~Progesterone: Progesterone therapy involves taking a daily pill of 200 mg Prometrium for the same 3 days that the estradiol is taken."
10900186|NCT00565916|BG001|Baseline|Estrogen Plus Placebo|"Hormone replacement therapy (HRT): estrogen plus placebo~Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).~Placebo Progesterone: Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken."
10900187|NCT00565916|BG002|Baseline|Total|Total of all reporting groups
10900188|NCT00565916|FG000|Participant Flow|Hormone Replacement Therapy (HRT): Estrogen Plus Progesterone|"Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).~Progesterone: Progesterone therapy involves taking a daily pill of 200 mg Prometrium for the same 3 days that the estradiol is taken."
10900189|NCT00565916|FG001|Participant Flow|Estrogen Plus Placebo|"Hormone replacement therapy (HRT): estrogen plus placebo~Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).~Placebo Progesterone: Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken."
10900190|NCT00565916|OG000|Outcome|Estrogen Plus Progesterone|"Hormone replacement therapy (HRT): estrogen plus progesterone~Estrogen: Estrogen only plus placebo: estradiol topical patch 0.3 mg placed on the lower abdomen for 3 days plus an oral placebo.~Other procedures: heart metabolism tests which includes a positron-emission tomography (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).~Progesterone: Estrogen plus progesterone: estradiol with oral progesterone (Prometrium, 200 mg/day) for 3 days, instead of placebo. Progesterone therapy involves taking a daily oral pill of 200 mg Prometrium for the same 3 days that the estradiol is taken."
10900191|NCT00565916|OG001|Outcome|Estrogen Plus Placebo|"Hormone replacement therapy (HRT): estrogen plus placebo~Estrogen: Estrogen only plus placebo: estradiol topical patch 0.3 mg placed on the lower abdomen for 3 days plus an oral placebo.~Other procedures: heart metabolism tests which includes a positron-emission tomography (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).~Placebo: Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken."
10900192|NCT00565916|EG000|Reported Event|Estrogen Plus Progesterone|"Hormone replacement therapy (HRT): estrogen plus progesterone~Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).~Progesterone: Progesterone therapy involves taking a daily pill of 200 mg Prometrium for the same 3 days that the estradiol is taken."
10900193|NCT00565916|EG001|Reported Event|Estrogen Plus Placebo|"Hormone replacement therapy (HRT): estrogen plus placebo~Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).~Placebo Progesterone: Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken."
10900194|NCT00566020|BG000|Baseline|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
10900195|NCT00566020|FG000|Participant Flow|Lamotrigine - Dosage Adjustment Phase|Lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation
11090838|NCT01531738|FG001|Participant Flow|Bariatric Surgery|obese patients due to undergo gastric bypass or gastric banding
11090839|NCT01531738|OG000|Outcome|Control|Normal weight healthy volunteers
11090840|NCT01531738|OG001|Outcome|Bariatric Surgery|obese patients due to undergo gastric bypass or gastric banding
11090841|NCT01531738|EG000|Reported Event|Control|Normal weight healthy volunteers
11090842|NCT01531738|EG001|Reported Event|Bariatric Surgery|obese patients due to undergo gastric bypass or gastric banding
10900196|NCT00566020|FG001|Participant Flow|Lamotrigine - Long-term Administration Phase|Lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
10900197|NCT00566020|OG000|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
10900198|NCT00566020|OG000|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
10900199|NCT00566020|EG000|Reported Event|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
10900200|NCT00566098|BG000|Baseline|MILs in Patients Undergoing an Autologous Peripheral SCT|"therapeutic autologous lymphocytes~therapeutic tumor infiltrating lymphocytes~melphalan~autologous hematopoietic stem cell transplantation"
10900201|NCT00566098|FG000|Participant Flow|MILs in Patients Undergoing an Autologous Peripheral SCT|"therapeutic autologous lymphocytes~therapeutic tumor infiltrating lymphocytes~melphalan~autologous hematopoietic stem cell transplantation"
10900202|NCT00566098|OG000|Outcome|MILs in Patients Undergoing an Autologous Peripheral SCT|"therapeutic autologous lymphocytes~therapeutic tumor infiltrating lymphocytes~melphalan~autologous hematopoietic stem cell transplantation"
10900203|NCT00566098|OG000|Outcome|MILs in Patients Undergoing an Autologous Peripheral SCT|therapeutic autologous lymphocytes
10900204|NCT00566098|EG000|Reported Event|ASCT+MILs|Autologous stem cell transplant with a conditioning regimen of melphalan 100 mg/m^2 on each of Days -2 and -1. Infusion of activated marrow infiltrating lymphocytes (MILs) on Day 3. PCV13 vaccine will be given before and/or after Day 0 depending on when participants are enrolled.
10900205|NCT00566111|BG000|Baseline|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
10900206|NCT00566111|BG001|Baseline|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
10900207|NCT00566111|BG002|Baseline|Total|Total of all reporting groups
11171794|NCT02005354|BG001|Baseline|TENS Placebo Comparator|"Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient).~Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain"
10900208|NCT00566111|FG000|Participant Flow|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
10900209|NCT00566111|FG001|Participant Flow|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
10900210|NCT00566111|OG000|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
10900211|NCT00566111|OG001|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
10900212|NCT00566111|EG000|Reported Event|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
10900213|NCT00566111|EG001|Reported Event|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
10900214|NCT00566150|BG000|Baseline|Levetiracetam|Subjects on active study medication.
11171795|NCT02005354|BG002|Baseline|Total|Total of all reporting groups
10900215|NCT00566150|BG001|Baseline|Placebo|Subjects assigned to placebo control group.
10900216|NCT00566150|BG002|Baseline|Total|Total of all reporting groups
10900217|NCT00566150|FG000|Participant Flow|Levetiracetam|Subjects on active study medication.
10900218|NCT00566150|FG001|Participant Flow|Placebo|Subjects assigned to placebo control group.
10900219|NCT00566150|OG000|Outcome|Levetiracetam|Subjects on active study medication.
10900220|NCT00566150|OG001|Outcome|Placebo|Subjects assigned to placebo control group.
10900221|NCT00566150|EG000|Reported Event|Levetiracetam|Subjects on active study medication.
10900222|NCT00566150|EG001|Reported Event|Placebo|Subjects assigned to placebo control group.
10900223|NCT00566228|BG000|Baseline|Immunologic Autograft Engineering|Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
10900224|NCT00566228|BG001|Baseline|Standard Autograft Collection|Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
10900225|NCT00566228|BG002|Baseline|Total|Total of all reporting groups
10900226|NCT00566228|FG000|Participant Flow|Immunologic Autograft Engineering|Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
10900227|NCT00566228|FG001|Participant Flow|Standard Autograft Collection|Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
10900228|NCT00566228|OG000|Outcome|Immunologic Autograft Engineering|Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
10900229|NCT00566228|OG001|Outcome|Standard Autograft Collection|Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
10900230|NCT00566228|EG000|Reported Event|Immunologic Autograft Engineering|Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
10900231|NCT00566228|EG001|Reported Event|Standard Autograft Collection|Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
11342277|NCT03703817|FG001|Participant Flow|Adalimumab|Participants who had been using adalimumab for more than 6 months or more and less than 2 years for RA treatment were included in the group.
10900232|NCT00566254|BG000|Baseline|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
10900233|NCT00566254|BG001|Baseline|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
10900234|NCT00566254|BG002|Baseline|Total|Total of all reporting groups
10900235|NCT00566254|FG000|Participant Flow|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
10900236|NCT00566254|FG001|Participant Flow|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
10900237|NCT00566254|OG000|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
10900238|NCT00566254|OG001|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
10900239|NCT00566254|EG000|Reported Event|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
10900240|NCT00566254|EG001|Reported Event|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
10900241|NCT00566501|BG000|Baseline|Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)|Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205).
10900242|NCT00566501|BG001|Baseline|Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)|Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg IR in the preceding double-blind study E2020-G000-326 (NCT00478205).
10900243|NCT00566501|BG002|Baseline|Total|Total of all reporting groups
10900244|NCT00566501|FG000|Participant Flow|Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)|Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205).
10900245|NCT00566501|FG001|Participant Flow|Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)|Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg IR in the preceding double-blind study E2020-G000-326 (NCT00478205).
11171796|NCT02005354|FG000|Participant Flow|TENS Intervention|"The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a strong but comfortable sensation. From previous studies, this is likely to be 50-110Hz.~The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study.~All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)"
10900246|NCT00566501|OG000|Outcome|Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)|Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205).
10900247|NCT00566501|OG001|Outcome|Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)|Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg IR in the preceding double-blind study E2020-G000-326 (NCT00478205).
10900248|NCT00566501|EG000|Reported Event|Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)|Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205).
10900249|NCT00566501|EG001|Reported Event|Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)|Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg IR in the preceding double-blind study E2020-G000-326 (NCT00478205).
10900250|NCT00566527|BG000|Baseline|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
11342278|NCT03703817|OG000|Outcome|Tofacitinib Citrate|Participants who had been using tofacitinib citrate for more than 6 months or more and less than 2 years for RA treatment were included in the group.
10900251|NCT00566527|BG001|Baseline|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
10900252|NCT00566527|BG002|Baseline|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
10900253|NCT00566527|BG003|Baseline|Total|Total of all reporting groups
10900254|NCT00566527|FG000|Participant Flow|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
10900255|NCT00566527|FG001|Participant Flow|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
10900256|NCT00566527|FG002|Participant Flow|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
10900257|NCT00566527|OG000|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
10900258|NCT00566527|OG001|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
10900259|NCT00566527|OG000|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
10900260|NCT00566527|OG001|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
10900261|NCT00566527|OG002|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
10900262|NCT00566527|EG000|Reported Event|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
10900263|NCT00566527|EG001|Reported Event|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
10900264|NCT00566527|EG002|Reported Event|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
10900265|NCT00566540|BG000|Baseline|Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)|"PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2.~SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3.~INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation.~POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10.~Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.~Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod"
10900266|NCT00566540|FG000|Participant Flow|Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)|"PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2.~SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3.~INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation.~POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10.~Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.~Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod"
10900267|NCT00566540|OG000|Outcome|Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)|"PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2.~SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3.~INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation.~POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10.~Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.~Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod"
10900268|NCT00566540|EG000|Reported Event|Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)|"PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2.~SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3.~INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation.~POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10.~Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.~Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod"
10900269|NCT00566579|BG000|Baseline|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
10900270|NCT00566579|BG001|Baseline|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
10900271|NCT00566579|BG002|Baseline|Total|Total of all reporting groups
10900272|NCT00566579|FG000|Participant Flow|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
10900273|NCT00566579|FG001|Participant Flow|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
10900274|NCT00566579|OG000|Outcome|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
10900275|NCT00566579|OG001|Outcome|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
10900276|NCT00566579|EG000|Reported Event|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
10900277|NCT00566579|EG001|Reported Event|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
11171797|NCT02005354|FG001|Participant Flow|TENS Placebo Comparator|"Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient).~Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain"
11171798|NCT02005354|OG000|Outcome|TENS Intervention|"The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a strong but comfortable sensation. From previous studies, this is likely to be 50-110Hz.~The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study.~All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)"
11171799|NCT02005354|OG001|Outcome|TENS Placebo Comparator|"Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient).~Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain"
11171800|NCT02005354|EG000|Reported Event|TENS Intervention|"The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a strong but comfortable sensation. From previous studies, this is likely to be 50-110Hz.~The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study.~All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)"
11171801|NCT02005354|EG001|Reported Event|TENS Placebo Comparator|"Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient).~Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain"
10900278|NCT00566631|BG000|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
10900279|NCT00566631|FG000|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
10900280|NCT00566631|OG000|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
10900281|NCT00566631|EG000|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
10900282|NCT00566696|BG000|Baseline|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
10900283|NCT00566696|FG000|Participant Flow|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
10900284|NCT00566696|OG000|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
11171802|NCT02005393|BG000|Baseline|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System immediately followed by Image Acquisition with NBI~FICE Image Acquisition System: Images Captured with FICE Device"
11171803|NCT02005393|FG000|Participant Flow|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition immediately followed by NBI Image Acquisition~FICE Image Acquisition System: Images Captured with FICE Device"
10900285|NCT00566696|EG000|Reported Event|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
10900286|NCT00566709|BG000|Baseline|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
10900287|NCT00566709|BG001|Baseline|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
10900288|NCT00566709|BG002|Baseline|Total|Total of all reporting groups
11171804|NCT02005393|OG000|Outcome|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System, immediately followed by NBI Image Acquisition; always in that order.~FICE Image Acquisition System: Images Captured with FICE Device"
10900289|NCT00566709|FG000|Participant Flow|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
10900290|NCT00566709|FG001|Participant Flow|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
10900291|NCT00566709|OG000|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
10900292|NCT00566709|OG001|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
10900293|NCT00566709|EG000|Reported Event|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
10900294|NCT00566709|EG001|Reported Event|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
10900295|NCT00566722|BG000|Baseline|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
10900296|NCT00566722|BG001|Baseline|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
10900297|NCT00566722|BG002|Baseline|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
10900298|NCT00566722|BG003|Baseline|Total|Total of all reporting groups
10900299|NCT00566722|FG000|Participant Flow|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
10900300|NCT00566722|FG001|Participant Flow|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
10900301|NCT00566722|FG002|Participant Flow|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
11171805|NCT02005393|EG000|Reported Event|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System, immediately followed by Image Acquisition with NBI~FICE Image Acquisition System: Images Captured with FICE Device~No AE's"
11342279|NCT03703817|OG001|Outcome|Adalimumab|Participants who had been using adalimumab for more than 6 months or more and less than 2 years for RA treatment were included in the group.
10914839|NCT00633009|BG002|Baseline|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
10900302|NCT00566722|OG000|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
10900303|NCT00566722|OG001|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
10900304|NCT00566722|OG002|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
10900305|NCT00566722|OG000|Outcome|Sub-optimal Response to MTX|
10900306|NCT00566722|OG001|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|
10900307|NCT00566722|OG002|Outcome|Sub-optimal Response to Etanercept|
10900308|NCT00566722|EG000|Reported Event|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
10900309|NCT00566722|EG001|Reported Event|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
10900310|NCT00566722|EG002|Reported Event|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
10900311|NCT00566735|BG000|Baseline|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
10900312|NCT00566735|BG001|Baseline|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
10900313|NCT00566735|BG002|Baseline|Total|Total of all reporting groups
10900314|NCT00566735|FG000|Participant Flow|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
10900315|NCT00566735|FG001|Participant Flow|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
10900316|NCT00566735|OG000|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
10900317|NCT00566735|OG001|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
10900318|NCT00566735|EG000|Reported Event|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
10900319|NCT00566735|EG001|Reported Event|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
10914840|NCT00633009|BG003|Baseline|Total|Total of all reporting groups
10900320|NCT00566813|BG000|Baseline|Islet Cells|Islet transplantation and the Edmonton protocol of steroid free immunosuppression
10900321|NCT00566813|BG001|Baseline|Islet Cells + Etanercept + Exenatide|Edmonton Protocol, etanercept ,exenatide
10900322|NCT00566813|BG002|Baseline|Total|Total of all reporting groups
10900323|NCT00566813|FG000|Participant Flow|Group 1 (Islet Cells)|1-3 Islet transplants by the Edmonton Protocol of Steroid Free Immunosuppression using daclizumab 1 mg/kg IV immediately pre-transplant and 2, 4, 6, and 8 weeks after transplant; sirolimus dosed to maintain serum trough levels 12-15 ng/mL for three months post-transplant and 7-10 ng/mL therafter; tacrolimus dosed to maintain serum trough levels 3-6 ng/mL throughout the study.
11171806|NCT02005484|BG000|Baseline|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
11171807|NCT02005484|FG000|Participant Flow|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
10900324|NCT00566813|FG001|Participant Flow|Group 2 (Islet Cells + Etanercept + Exenatide)|1-3 islet transplants by the Edmonton Protocol of Steroid Free Immunosuppression using daclizumab 1 mg/kg IV immediately pre-transplant and 2, 4, 6, and 8 weeks after transplant; sirolimus dosed to maintain serum trough levels 12-15 ng/mL for 3 months post-transplant and 7-10 mg/mL thereafter; tacrolimus dosed to serum trough levels 3-6 ng/mL throughout the study; etanercept 50 mg IV pre-transplant, 25 mg subcutaneously post-transplant Days 3, 7, 10; exenatide 5-mcg subcutaneously twice daily for I week, then up to 10-mcg twice daily for 6 months after the last islet transplant.
10900325|NCT00566813|OG000|Outcome|Islet Cells|1-3 Islet transplants by the Edmonton Protocol of Steroid Free Immunosuppression using daclizumab 1 mg/kg IV immediately pre-transplant and 2, 4, 6, and 8 weeks after transplant; sirolimus dosed to maintain serum trough levels 12-15 ng/mL for three months post-transplant and 7-10 ng/mL therafter; tacrolimus dosed to maintain serum trough levels 3-6 ng/mL throughout the study.
10900326|NCT00566813|OG001|Outcome|Islet Cells + Etanercept + Exenatide|1-3 islet transplants by the Edmonton Protocol of Steroid Free Immunosuppression using daclizumab 1 mg/kg IV immediately pre-transplant and 2, 4, 6, and 8 weeks after transplant; sirolimus dosed to maintain serum trough levels 12-15 ng/mL for 3 months post-transplant and 7-10 mg/mL thereafter; tacrolimus dosed to serum trough levels 3-6 ng/mL throughout the study; etanercept 50 mg IV pre-transplant, 25 mg subcutaneously post-transplant Days 3, 7, 10; exenatide 5-mcg subcutaneously twice daily for I week, then up to 10-mcg twice daily for 6 months after the last islet transplant.
10900327|NCT00566813|EG000|Reported Event|Islet Cells|1-3 Islet transplants by the Edmonton Protocol of Steroid Free Immunosuppression using daclizumab 1 mg/kg IV immediately pre-transplant and 2, 4, 6, and 8 weeks after transplant; sirolimus dosed to maintain serum trough levels 12-15 ng/mL for three months post-transplant and 7-10 ng/mL therafter; tacrolimus dosed to maintain serum trough levels 3-6 ng/mL throughout the study.
10900328|NCT00566813|EG001|Reported Event|Islet Cells + Etanercept + Exenatide|1-3 islet transplants by the Edmonton Protocol of Steroid Free Immunosuppression using daclizumab 1 mg/kg IV immediately pre-transplant and 2, 4, 6, and 8 weeks after transplant; sirolimus dosed to maintain serum trough levels 12-15 ng/mL for 3 months post-transplant and 7-10 mg/mL thereafter; tacrolimus dosed to serum trough levels 3-6 ng/mL throughout the study; etanercept 50 mg IV pre-transplant, 25 mg subcutaneously post-transplant Days 3, 7, 10; exenatide 5-mcg subcutaneously twice daily for I week, then up to 10-mcg twice daily for 6 months after the last islet transplant.
10900329|NCT00566852|BG000|Baseline|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
10900330|NCT00566852|BG001|Baseline|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
10900331|NCT00566852|BG002|Baseline|Total|Total of all reporting groups
10900332|NCT00566852|FG000|Participant Flow|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
10900333|NCT00566852|FG001|Participant Flow|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
10900334|NCT00566852|OG000|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
10900335|NCT00566852|OG001|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
10900336|NCT00566852|EG000|Reported Event|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
10900337|NCT00566852|EG001|Reported Event|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
10900338|NCT00566930|BG000|Baseline|Control|control group with no treatment only regular assessment appointments
10900339|NCT00566930|BG001|Baseline|Spinal Manipulation|spinal manipulation
10900340|NCT00566930|BG002|Baseline|Spinal Manipulation and Exercises|Spinal manipulation + exercises
10900341|NCT00566930|BG003|Baseline|Total|Total of all reporting groups
11171808|NCT02005484|OG000|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
11171809|NCT02005484|EG000|Reported Event|Trastuzumab Monotherapy|Participants received trastuzumab via IV infusion once weekly at an initial dose of 4 mg/kg at Visit 1, and 2 mg/kg at each subsequent visit for a maximum of 33 visits.
11171810|NCT02005510|BG000|Baseline|In-home HPV Screening|"Usual care PLUS a mailed in-home high-risk HPV testing kit (accompanied by an invitational letter, research information sheet, and illustrated instructions for using the kit). Usual care consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.~Mailed in-home high-risk HPV testing kit~Usual care"
11342280|NCT03703817|EG000|Reported Event|Tofacitinib Citrate|Participants who had been using tofacitinib citrate for more than 6 months or more and less than 2 years for RA treatment were included in the group.
10900342|NCT00566930|FG000|Participant Flow|Control|control group with no treatment only regular assessment appointments
10900343|NCT00566930|FG001|Participant Flow|Spinal Manipulation|spinal manipulation
10900344|NCT00566930|FG002|Participant Flow|Spinal Manipulation and Exercises|Spinal manipulation + exercises
10900345|NCT00566930|OG000|Outcome|Control|control group with no treatment only regular assessment appointments
10900346|NCT00566930|OG001|Outcome|Spinal Manipulation|spinal manipulation
10900347|NCT00566930|OG002|Outcome|Spinal Manipulation and Exercises|Spinal manipulation + exercises
10900348|NCT00566930|EG000|Reported Event|Control|control group with no treatment only regular assessment appointments
10900349|NCT00566930|EG001|Reported Event|Spinal Manipulation|spinal manipulation
10900350|NCT00566930|EG002|Reported Event|Spinal Manipulation and Exercises|Spinal manipulation + exercises
10900351|NCT00566943|BG000|Baseline|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
10900352|NCT00566943|BG001|Baseline|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
10900353|NCT00566943|BG002|Baseline|Total|Total of all reporting groups
10900354|NCT00566943|FG000|Participant Flow|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
10900355|NCT00566943|FG001|Participant Flow|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
10900356|NCT00566943|OG000|Outcome|Number of Subjects in Control Group|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
10900357|NCT00566943|OG001|Outcome|Number of Subjects in PSD Veritas Group|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
10900358|NCT00566943|OG000|Outcome|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
10900359|NCT00566943|OG001|Outcome|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
10900360|NCT00566943|OG000|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
10900361|NCT00566943|OG001|Outcome|Number of Subjects in PSD Veritas Arm Linear|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
10900362|NCT00566943|OG000|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines
10900363|NCT00566943|OG001|Outcome|Number of Subjects in PSD Veritas Arm|PSD Veritas is used as a buttress on stomach and/or GJ anastomosis.
10900364|NCT00566943|EG000|Reported Event|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
10900365|NCT00566943|EG001|Reported Event|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
10900366|NCT00566969|BG000|Baseline|Sugar Pill|"To be compared to active drug~sugar pill: Subjects randomized to placebo, carvedilol 25mg or 50mg"
10900367|NCT00566969|BG001|Baseline|Carvedilol 25 mg|"To be compared to placebo and Carvedilol 50 mg~carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
10900368|NCT00566969|BG002|Baseline|Carvedilol 50 mg|"To be compared to placebo and Carvedilol 25 mg~Carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
10900369|NCT00566969|BG003|Baseline|Total|Total of all reporting groups
10900370|NCT00566969|FG000|Participant Flow|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
10900371|NCT00566969|FG001|Participant Flow|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
10900372|NCT00566969|FG002|Participant Flow|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
10900373|NCT00566969|OG000|Outcome|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
10900374|NCT00566969|OG001|Outcome|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
10900375|NCT00566969|OG002|Outcome|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
10900376|NCT00566969|EG000|Reported Event|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
10900377|NCT00566969|EG001|Reported Event|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
10900378|NCT00566969|EG002|Reported Event|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
10900379|NCT00566982|BG000|Baseline|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
10900380|NCT00566982|BG001|Baseline|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
10900381|NCT00566982|BG002|Baseline|Total|Total of all reporting groups
10900382|NCT00566982|FG000|Participant Flow|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
10900383|NCT00566982|FG001|Participant Flow|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
10900384|NCT00566982|OG000|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
10900385|NCT00566982|OG001|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
10900386|NCT00566982|OG001|Outcome|Subjects on Placebo (Week 52)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
10900387|NCT00566982|OG002|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
10900388|NCT00566982|OG003|Outcome|Subjects on Ospemifene 60 mg/Day (Week 52)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
10900389|NCT00566982|EG000|Reported Event|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
10900390|NCT00566982|EG001|Reported Event|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
10900391|NCT00567008|BG000|Baseline|Varenicline|Varenicline (Chantix)
10900392|NCT00567008|BG001|Baseline|Placebo|Placebo
10900393|NCT00567008|BG002|Baseline|Total|Total of all reporting groups
10900394|NCT00567008|FG000|Participant Flow|Varenicline 2mg/Day|Varenicline (Chantix)
10900395|NCT00567008|FG001|Participant Flow|Placebo|Placebo
10900396|NCT00567008|OG000|Outcome|Varenicline|Varenicline (Chantix)
11171811|NCT02005510|BG001|Baseline|Usual Care|"Usual care. Usual care consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.~Usual care"
11171812|NCT02005510|BG002|Baseline|Total|Total of all reporting groups
10900397|NCT00567008|OG001|Outcome|Placebo|Placebo
10900398|NCT00567008|EG000|Reported Event|Varenicline|Varenicline (Chantix)
10900399|NCT00567008|EG001|Reported Event|Placebo|Placebo
10900400|NCT00567112|BG000|Baseline|All Randomized|Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2.
10900401|NCT00567112|FG000|Participant Flow|Treatment Group ABCD|"Period 1: Dry Filled Capsule (DFC) (fasted)~Period 2: Oral Compressed Tablet (OCT) (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
11171813|NCT02005510|FG000|Participant Flow|In-home HPV Screening|"Usual care PLUS a mailed in-home high-risk HPV testing kit (accompanied by an invitational letter, research information sheet, and illustrated instructions for using the kit). Usual care consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.~Mailed in-home high-risk HPV testing kit~Usual care"
11171814|NCT02005510|FG001|Participant Flow|Usual Care|"Usual care. Usual care consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.~Usual care"
11342281|NCT03703817|EG001|Reported Event|Adalimumab|Participants who had been using adalimumab for more than 6 months or more and less than 2 years for RA treatment were included in the group.
10900402|NCT00567112|FG001|Participant Flow|Treatment Group BACD|"Period 1: OCT (fasted)~Period 2: DFC (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
10900403|NCT00567112|FG002|Participant Flow|Treatment Group BCD|"Period 1: Not Applicable~Period 2: OCT (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
10900404|NCT00567112|OG000|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
10900405|NCT00567112|OG001|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
10900406|NCT00567112|OG001|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
10900407|NCT00567112|EG000|Reported Event|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
10900408|NCT00567112|EG001|Reported Event|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
10900409|NCT00567112|EG002|Reported Event|OCT (Before Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered before consumption of a standard breakfast
10900410|NCT00567112|EG003|Reported Event|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
10900411|NCT00567164|BG000|Baseline|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
10900412|NCT00567164|BG001|Baseline|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
10900413|NCT00567164|BG002|Baseline|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
10900414|NCT00567164|BG003|Baseline|Total|Total of all reporting groups
10900415|NCT00567164|FG000|Participant Flow|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
10900416|NCT00567164|FG001|Participant Flow|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
10900417|NCT00567164|FG002|Participant Flow|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
10900418|NCT00567164|OG000|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
10900419|NCT00567164|OG001|Outcome|Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2|Pooled FAS of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) (see first arm) and Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300). Regimen no. 2: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
10900420|NCT00567164|OG001|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
10900421|NCT00567164|OG002|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
10900422|NCT00567164|OG000|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
10900423|NCT00567164|OG001|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
10900424|NCT00567164|OG000|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
10900425|NCT00567164|EG000|Reported Event|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
10900426|NCT00567164|EG001|Reported Event|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
11357158|NCT03764449|OG003|Outcome|Cohort 2, Period 2|Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.
10900427|NCT00567164|EG002|Reported Event|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
10900428|NCT00567190|BG000|Baseline|Pertuzumab + Trastuzumab + Docetaxel|Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900429|NCT00567190|BG001|Baseline|Placebo + Trastuzumab + Docetaxel|Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900430|NCT00567190|BG002|Baseline|Total|Total of all reporting groups
10900431|NCT00567190|FG000|Participant Flow|Pertuzumab + Trastuzumab + Docetaxel|Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900432|NCT00567190|FG001|Participant Flow|Placebo + Trastuzumab + Docetaxel|Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900433|NCT00567190|OG000|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900434|NCT00567190|OG001|Outcome|Placebo + Trastuzumab + Docetaxel|Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
11171815|NCT02005510|OG000|Outcome|In-home HPV Screening|"Usual care PLUS a mailed in-home high-risk HPV testing kit (accompanied by an invitational letter, research information sheet, and illustrated instructions for using the kit). Usual care consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.~Mailed in-home high-risk HPV testing kit~Usual care"
10900435|NCT00567190|OG000|Outcome|Placebo + Trastuzumab + Docetaxel|This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900436|NCT00567190|OG001|Outcome|Pertuzumab + Trastuzumab + Docetaxel|This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
11171816|NCT02005510|OG001|Outcome|Usual Care|"Usual care. Usual care consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.~Usual care"
10900437|NCT00567190|OG002|Outcome|Crossover From Placebo to Pertuzumab|Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900438|NCT00567190|OG000|Outcome|Placebo + Trastuzumab + Docetaxel|This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900439|NCT00567190|EG000|Reported Event|Placebo + Trastuzumab + Docetaxel|This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900440|NCT00567190|EG001|Reported Event|Pertuzumab + Trastuzumab + Docetaxel|This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900441|NCT00567190|EG002|Reported Event|Crossover From Placebo to Pertuzumab|Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
10900442|NCT00567229|BG000|Baseline|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
10900443|NCT00567229|FG000|Participant Flow|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
10900444|NCT00567229|OG000|Outcome|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
10900445|NCT00567229|EG000|Reported Event|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
11171817|NCT02005510|EG000|Reported Event|In-home HPV Screening|"Usual care PLUS a mailed in-home high-risk HPV testing kit (accompanied by an invitational letter, research information sheet, and illustrated instructions for using the kit). Usual care consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.~Mailed in-home high-risk HPV testing kit~Usual care"
11233354|NCT02426918|BG000|Baseline|Debio 1450 80 mg/120 mg BID|Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.
10900446|NCT00567242|BG000|Baseline|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
10900447|NCT00567242|BG001|Baseline|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
10900448|NCT00567242|BG002|Baseline|Total|Total of all reporting groups
10900449|NCT00567242|FG000|Participant Flow|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
10900450|NCT00567242|FG001|Participant Flow|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
10900451|NCT00567242|OG000|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
10900452|NCT00567242|OG001|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
10900453|NCT00567242|EG000|Reported Event|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
10900454|NCT00567242|EG001|Reported Event|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
10900455|NCT00567255|BG000|Baseline|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
10900456|NCT00567255|BG001|Baseline|Placebo|Placebo
10900457|NCT00567255|BG002|Baseline|Total|Total of all reporting groups
10900458|NCT00567255|FG000|Participant Flow|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
10900459|NCT00567255|FG001|Participant Flow|Placebo|Placebo
10900460|NCT00567255|OG000|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
10900461|NCT00567255|OG001|Outcome|Placebo|Placebo
10900462|NCT00567255|EG000|Reported Event|NB32/48|"Naltrexone SR 32 mg/bupropion SR 360 mg/day or naltrexone SR 48 mg/bupropion SR 360 mg/day~Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).~NB32/48 group includes all participants in the safety analysis set randomized to NB32 at baseline, regardless of re-randomization status."
10900463|NCT00567255|EG001|Reported Event|Placebo|Placebo
10900464|NCT00567268|BG000|Baseline|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
10900465|NCT00567268|FG000|Participant Flow|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
10900466|NCT00567268|OG000|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
10900467|NCT00567268|OG000|Outcome|Age <15 Years|Participants <15 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
10900468|NCT00567268|OG001|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
10900469|NCT00567268|OG002|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
10900470|NCT00567268|OG003|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
10900471|NCT00567268|OG004|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
10900472|NCT00567268|OG005|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
10900473|NCT00567268|OG006|Outcome|Age >=65 Years|Participants >=65 years years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
10900474|NCT00567268|OG000|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
10900475|NCT00567268|OG001|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
10900476|NCT00567268|OG002|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
10900477|NCT00567268|OG003|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
10900478|NCT00567268|OG004|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
10900479|NCT00567268|OG000|Outcome|Age <65 Years|Participants <65 years of age who responded to the treatment with gabapentin
10900480|NCT00567268|OG001|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
10900481|NCT00567268|OG000|Outcome|Age <15 Years|Participants <15 years of age who responded to the treatment with gabapentin
10900482|NCT00567268|OG001|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age who responded to the treatment with gabapentin
10900483|NCT00567268|OG002|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age who responded to the treatment with gabapentin
10900484|NCT00567268|OG003|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age who responded to the treatment with gabapentin
10900485|NCT00567268|OG004|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age who responded to the treatment with gabapentin
10900486|NCT00567268|OG005|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age who responded to the treatment with gabapentin
10900487|NCT00567268|OG006|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
10900488|NCT00567268|OG000|Outcome|Mild|Participants with mild epilepsy who responded to the treatment with gabapentin
10900489|NCT00567268|OG001|Outcome|Moderate|Participants with moderate epilepsy who responded to the treatment with gabapentin
10900490|NCT00567268|OG002|Outcome|Severe|Participants with severe epilepsy who responded to the treatment with gabapentin
10900491|NCT00567268|OG000|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure below 8 who responded to the treatment with gabapentin
10900492|NCT00567268|OG001|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8 who responded to the treatment with gabapentin
11171818|NCT02005510|EG001|Reported Event|Usual Care|"Usual care. Usual care consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.~Usual care"
10900493|NCT00567268|OG002|Outcome|Unknown|Participants with unknown frequency of baseline episodes who responded to the treatment with gabapentin
10900494|NCT00567268|OG000|Outcome|CLcr >=60 mL/Min|Participants with baseline creatinine clearance >=60 mL/min
10900495|NCT00567268|OG001|Outcome|CLcr >=30 and <60 mL/Min|Participants with baseline creatinine clearance >=30 and <60 mL/min
10900496|NCT00567268|OG002|Outcome|CLcr >=15 and <30 mL/Min|Participants with baseline creatinine clearance >=15 and <30 mL/min
10900497|NCT00567268|OG003|Outcome|CLcr >=5 and <15 mL/Min|Participants with baseline creatinine clearance >=5 and <15 mL/min
10900498|NCT00567268|OG004|Outcome|CLcr <5 mL/Min|Participants with baseline creatinine clearance <5 mL/min
10900499|NCT00567268|OG005|Outcome|Unkown|Participants with unkown baseline creatinine clearance
10900500|NCT00567268|OG000|Outcome|Presence of Non-Drug Therapy|Participants with non-drug therapy who responded to treatment with gabapentin
10900501|NCT00567268|OG001|Outcome|Absence of Non-Drug Therapy|Participants without non-drug therapy who responded to treatment with gabapentin
10900502|NCT00567268|EG000|Reported Event|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
10900503|NCT00567307|BG000|Baseline|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
10900504|NCT00567307|BG001|Baseline|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
10900505|NCT00567307|BG002|Baseline|Total|Total of all reporting groups
10900506|NCT00567307|FG000|Participant Flow|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
10900507|NCT00567307|FG001|Participant Flow|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
10900508|NCT00567307|OG000|Outcome|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
10900509|NCT00567307|OG001|Outcome|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
10900510|NCT00567307|EG000|Reported Event|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
10900511|NCT00567307|EG001|Reported Event|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
10900512|NCT00567320|BG000|Baseline|Varenicline|Varenicline 2 mg per day.
10900513|NCT00567320|BG001|Baseline|Placebo|This is the Placebo condition
10900514|NCT00567320|BG002|Baseline|Total|Total of all reporting groups
10900515|NCT00567320|FG000|Participant Flow|Varenicline|Varenicline 2 mg per day.
10900516|NCT00567320|FG001|Participant Flow|Placebo|This is the Placebo condition
10900517|NCT00567320|OG000|Outcome|Varenicline|Varenicline 2 mg per day.
10900518|NCT00567320|OG001|Outcome|Placebo|This is the Placebo condition
10900519|NCT00567320|EG000|Reported Event|Varenicline|Varenicline 2 mg per day.
10900520|NCT00567320|EG001|Reported Event|Placebo|This is the Placebo condition
10900521|NCT00567359|BG000|Baseline|Erlotinib|Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
10900522|NCT00567359|FG000|Participant Flow|Erlotinib|Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
10900523|NCT00567359|OG000|Outcome|Erlotinib|Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
10900524|NCT00567359|EG000|Reported Event|Erlotinib|Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
10900525|NCT00567398|BG000|Baseline|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
10900526|NCT00567398|BG001|Baseline|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
10900527|NCT00567398|BG002|Baseline|Total|Total of all reporting groups
10900528|NCT00567398|FG000|Participant Flow|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
10900529|NCT00567398|FG001|Participant Flow|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
10900530|NCT00567398|OG000|Outcome|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
10900531|NCT00567398|OG001|Outcome|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
10900532|NCT00567398|EG000|Reported Event|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
10900533|NCT00567398|EG001|Reported Event|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
10900534|NCT00567476|BG000|Baseline|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
10900535|NCT00567476|BG001|Baseline|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
10900536|NCT00567476|BG002|Baseline|Total|Total of all reporting groups
10900537|NCT00567476|FG000|Participant Flow|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
10900538|NCT00567476|FG001|Participant Flow|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
10900539|NCT00567476|OG000|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
10900540|NCT00567476|OG001|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
10900541|NCT00567476|EG000|Reported Event|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
10900542|NCT00567476|EG001|Reported Event|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
10900543|NCT00567489|BG000|Baseline|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
10900544|NCT00567489|BG001|Baseline|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
10900545|NCT00567489|BG002|Baseline|Total|Total of all reporting groups
10900546|NCT00567489|FG000|Participant Flow|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
10900547|NCT00567489|FG001|Participant Flow|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
10900548|NCT00567489|OG000|Outcome|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
10900549|NCT00567489|OG001|Outcome|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
11171819|NCT02005536|BG000|Baseline|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
11171820|NCT02005536|FG000|Participant Flow|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
11171821|NCT02005536|OG000|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
11171822|NCT02005536|EG000|Reported Event|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
11171823|NCT02005549|BG000|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
11171824|NCT02005549|FG000|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 milligrams/kilogram (mg/kg) intravenously (IV), followed by docetaxel 75 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 950 mg/m^2 orally (PO) twice daily (BID) within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
11171825|NCT02005549|OG000|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
10900550|NCT00567489|EG000|Reported Event|Non-Glucose Sparing Prescriptions|Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
10900551|NCT00567489|EG001|Reported Event|Glucose Sparing Prescriptions|Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
10900552|NCT00567502|BG000|Baseline|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
10900553|NCT00567502|BG001|Baseline|XAGRID+Other (Cytoreductives)|Participants who received XAGRID along with Other cytoreductives drugs at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
10900554|NCT00567502|BG002|Baseline|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
10900555|NCT00567502|BG003|Baseline|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
11171826|NCT02005549|EG000|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
11171827|NCT02005562|BG000|Baseline|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
11171828|NCT02005562|BG001|Baseline|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
11171829|NCT02005562|BG002|Baseline|Total|Total of all reporting groups
11171830|NCT02005562|FG000|Participant Flow|Mycophenolate Mofetil, Adapted Dose|Participants received mycophenolate mofetil (MMF), 3 grams (g), tablets or capsules, orally (PO), every 12 hours (q12h) adapted to mycophenolic acid (MPA) by area under the curve (AUC) on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a 2 hour postdose (C2) level equal to (=) 1000 to 1500 nanograms per milliliter (ng/mL) from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 milligrams (mg), intravenously (IV), on Day -1 or Day 0, and 0.5 mg per kilogram (mg/kg), PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-interleukin (IL)-2R, per the investigator's discretion.
10900556|NCT00567502|BG004|Baseline|Total|Total of all reporting groups
10900557|NCT00567502|FG000|Participant Flow|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion
10900558|NCT00567502|FG001|Participant Flow|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
10900559|NCT00567502|FG002|Participant Flow|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
10900560|NCT00567502|FG003|Participant Flow|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
10900561|NCT00567502|OG000|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
10900562|NCT00567502|OG001|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
10900563|NCT00567502|OG002|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
10900564|NCT00567502|OG003|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
11171831|NCT02005562|FG001|Participant Flow|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
11171832|NCT02005562|OG000|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
10900565|NCT00567502|OG002|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
10900566|NCT00567502|OG000|Outcome|XAGRID Taken|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period."
10900567|NCT00567502|OG001|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
11171833|NCT02005562|OG001|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
11171834|NCT02005562|EG000|Reported Event|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
11233355|NCT02426918|BG001|Baseline|Debio 1450 160 mg/240 mg BID|Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.
11171835|NCT02005562|EG001|Reported Event|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
10900568|NCT00567502|OG002|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900569|NCT00567502|OG003|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900570|NCT00567502|OG004|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900571|NCT00567502|OG005|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900572|NCT00567502|OG006|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900573|NCT00567502|OG007|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900574|NCT00567502|OG008|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900575|NCT00567502|OG000|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900576|NCT00567502|OG000|Outcome|XAGRID|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
10900577|NCT00567502|OG001|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years. Other Cytoreductives included Hydroxyurea, Interferonalpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
10900578|NCT00567502|EG000|Reported Event|XAGRID|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period."
10900579|NCT00567502|EG001|Reported Event|Other (Cytoreductives)|"Participants who received other (cytoreductives) from  other (cytoreductives or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."
10900580|NCT00567541|BG000|Baseline|Active BBPM Stimulation|Active Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
10900581|NCT00567541|BG001|Baseline|Sham BBPM Stimulation|Sham Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation.
10900582|NCT00567541|BG002|Baseline|Total|Total of all reporting groups
10900583|NCT00567541|FG000|Participant Flow|Active BBPM Stimulation|"The Battery Powered Microneuromodulator (BBPM) is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.~Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) will be programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation. therapeutic treatment."
10900584|NCT00567541|FG001|Participant Flow|Sham BBPM Stimulation|"The Battery Powered Microneuromodulator(BBPM) will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.~Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation."
10900585|NCT00567541|OG000|Outcome|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
11171836|NCT02005601|BG000|Baseline|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
11171837|NCT02005601|BG001|Baseline|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
11171838|NCT02005601|BG002|Baseline|Total|Total of all reporting groups
10900586|NCT00567541|OG001|Outcome|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
10900587|NCT00567541|EG000|Reported Event|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
10900588|NCT00567541|EG001|Reported Event|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
10900589|NCT00567593|BG000|Baseline|Rosaglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
10900590|NCT00567593|FG000|Participant Flow|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
10900591|NCT00567593|OG000|Outcome|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
10900592|NCT00567593|EG000|Reported Event|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
10900593|NCT00567840|BG000|Baseline|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
10900594|NCT00567840|BG001|Baseline|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
10900595|NCT00567840|BG002|Baseline|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
10900596|NCT00567840|BG003|Baseline|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
10900597|NCT00567840|BG004|Baseline|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
10900598|NCT00567840|BG005|Baseline|Total|Total of all reporting groups
10900599|NCT00567840|FG000|Participant Flow|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
10900600|NCT00567840|FG001|Participant Flow|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
10900601|NCT00567840|FG002|Participant Flow|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
10900602|NCT00567840|FG003|Participant Flow|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
10900603|NCT00567840|FG004|Participant Flow|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
10900604|NCT00567840|OG000|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
10900605|NCT00567840|OG001|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
10900606|NCT00567840|OG002|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
10900607|NCT00567840|OG003|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
10900608|NCT00567840|OG004|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
10900609|NCT00567840|EG000|Reported Event|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
10900610|NCT00567840|EG001|Reported Event|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
10900611|NCT00567840|EG002|Reported Event|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
10900612|NCT00567840|EG003|Reported Event|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
10900613|NCT00567840|EG004|Reported Event|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
10900614|NCT00567879|BG000|Baseline|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900615|NCT00567879|BG001|Baseline|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900616|NCT00567879|BG002|Baseline|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900617|NCT00567879|BG003|Baseline|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900618|NCT00567879|BG004|Baseline|Oral Arm - Schedule B 15mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900619|NCT00567879|BG005|Baseline|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900620|NCT00567879|BG006|Baseline|Total|Total of all reporting groups
10900621|NCT00567879|FG000|Participant Flow|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900622|NCT00567879|FG001|Participant Flow|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900623|NCT00567879|FG002|Participant Flow|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900624|NCT00567879|FG003|Participant Flow|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900625|NCT00567879|FG004|Participant Flow|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900626|NCT00567879|FG005|Participant Flow|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900627|NCT00567879|OG000|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900628|NCT00567879|OG001|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900629|NCT00567879|OG002|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900630|NCT00567879|OG003|Outcome|Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900631|NCT00567879|OG004|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900632|NCT00567879|OG005|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900633|NCT00567879|OG006|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900634|NCT00567879|OG003|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900635|NCT00567879|OG004|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900636|NCT00567879|OG005|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900637|NCT00567879|EG000|Reported Event|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900638|NCT00567879|EG001|Reported Event|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900639|NCT00567879|EG002|Reported Event|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
10900640|NCT00567879|EG003|Reported Event|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900641|NCT00567879|EG004|Reported Event|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900642|NCT00567879|EG005|Reported Event|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
10900643|NCT00567892|BG000|Baseline|2 Week Treatment|Treatment (either active rTMS or sham)for 2 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 2 weeks
10900644|NCT00567892|BG001|Baseline|4 Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
10900645|NCT00567892|BG002|Baseline|Total|Total of all reporting groups
10900646|NCT00567892|FG000|Participant Flow|Active Then Sham rTMS Treatment (2 Weeks)|Active rTMS Treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks sham. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
10900647|NCT00567892|FG001|Participant Flow|Sham Then Active rTMS Treatment (2 Weeks)|Sham treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks Active rTMS Treatment.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
10900648|NCT00567892|FG002|Participant Flow|Active Then Sham rTMS Treatment (4 Weeks)|Active rTMS Treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks sham.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.One subject had a drop of THI larger than 20 points from baseline after first arm of treatment and did not get the second arm.
10900649|NCT00567892|FG003|Participant Flow|Sham Then Active rTMS Treatment (4 Weeks)|Sham treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks Active rTMS Treatment. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
10900650|NCT00567892|OG000|Outcome|2-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 2 weeks.
10900651|NCT00567892|OG001|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks.
10900652|NCT00567892|OG002|Outcome|4-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
11171839|NCT02005601|FG000|Participant Flow|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
11171840|NCT02005601|FG001|Participant Flow|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
10900653|NCT00567892|OG003|Outcome|4-weeks rTMS Sham Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
10900654|NCT00567892|OG000|Outcome|2-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold)
10900655|NCT00567892|OG001|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks).
10900656|NCT00567892|OG002|Outcome|4-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
10900657|NCT00567892|OG003|Outcome|4-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
10900658|NCT00567892|EG000|Reported Event|2 Weeks Treatment|Treatment (either active rTMS or sham) for two weeks followed by 2 weeks wash-out then treatment (opposite of first assignment)for two weeks
10900659|NCT00567892|EG001|Reported Event|Four Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
10900660|NCT00567996|BG000|Baseline|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900661|NCT00567996|BG001|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900662|NCT00567996|BG002|Baseline|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900663|NCT00567996|BG003|Baseline|Total|Total of all reporting groups
10900664|NCT00567996|FG000|Participant Flow|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900665|NCT00567996|FG001|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900666|NCT00567996|FG002|Participant Flow|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900667|NCT00567996|OG000|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900668|NCT00567996|OG001|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900669|NCT00567996|OG002|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
11171841|NCT02005601|OG000|Outcome|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
10900670|NCT00567996|EG000|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900671|NCT00567996|EG001|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900672|NCT00567996|EG002|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10900673|NCT00568022|BG000|Baseline|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900674|NCT00568022|BG001|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900675|NCT00568022|BG002|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900676|NCT00568022|BG003|Baseline|Total|Total of all reporting groups
10900677|NCT00568022|FG000|Participant Flow|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900678|NCT00568022|FG001|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|After receiving Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900679|NCT00568022|FG002|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|After receiving Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900680|NCT00568022|OG000|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900681|NCT00568022|OG001|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900682|NCT00568022|OG002|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900683|NCT00568022|OG000|Outcome|All Participants With Measurable Disease and Tumor Response|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥ 1 dose of ixabepilone and/or capecitabine in Cycle 1, completed adequate safety evaluations, and was observed for ≥ 21 days following the first dose or the participant experienced DLT.
10900684|NCT00568022|EG000|Reported Event|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each treatment cycle.
10900685|NCT00568022|EG001|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900686|NCT00568022|EG002|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
10900687|NCT00568061|BG000|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
10900688|NCT00568061|BG001|Baseline|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
10900689|NCT00568061|BG002|Baseline|Total|Total of all reporting groups
10900690|NCT00568061|FG000|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80 ppm
10900691|NCT00568061|FG001|Participant Flow|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80 ppm
10900692|NCT00568061|OG000|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
10900693|NCT00568061|OG001|Outcome|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
10900694|NCT00568061|OG000|Outcome|Nitric Oxide|nitric oxide for inhalation
10900695|NCT00568061|EG000|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
10900696|NCT00568061|EG001|Reported Event|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
10900697|NCT00568087|BG000|Baseline|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
10900698|NCT00568087|BG001|Baseline|Placebo|Identical placebo daily for 8 weeks
10900699|NCT00568087|BG002|Baseline|Total|Total of all reporting groups
10900700|NCT00568087|FG000|Participant Flow|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
10900701|NCT00568087|FG001|Participant Flow|Placebo|Identical placebo daily for 8 weeks
10900702|NCT00568087|OG000|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
10900703|NCT00568087|OG001|Outcome|Placebo|Identical placebo daily for 8 weeks
10900704|NCT00568087|EG000|Reported Event|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
10900705|NCT00568087|EG001|Reported Event|Placebo|Identical placebo daily for 8 weeks
10900706|NCT00568126|BG000|Baseline|Maca Root|"Subjects in this arm will be given 3g/day of maca root for 12 weeks~Maca Root: 3g/day of Maca Root for 12 weeks."
10900707|NCT00568126|BG001|Baseline|Placebo|"Subjects in this arm will receive inactive placebo for 12 weeks.~Placebo: Placebo provided by research pharmacy daily for 12 weeks."
10900708|NCT00568126|BG002|Baseline|Total|Total of all reporting groups
10900709|NCT00568126|FG000|Participant Flow|Maca Root|"Subjects in this arm will be given 3g/day of maca root for 12 weeks~Maca Root: 3g/day of Maca Root for 12 weeks."
10900710|NCT00568126|FG001|Participant Flow|Placebo|"Subjects in this arm will receive inactive placebo for 12 weeks.~Placebo: Placebo provided by research pharmacy daily for 12 weeks."
10900711|NCT00568126|OG000|Outcome|Maca Root|"Subjects in this arm will be given 3g/day of maca root for 12 weeks~Maca Root: 3g/day of Maca Root for 12 weeks."
10900712|NCT00568126|OG001|Outcome|Placebo|"Subjects in this arm will receive inactive placebo for 12 weeks.~Placebo: Placebo provided by research pharmacy daily for 12 weeks."
10900713|NCT00568126|EG000|Reported Event|Maca Root|"Subjects in this arm will be given 3g/day of maca root for 12 weeks~Maca Root: 3g/day of Maca Root for 12 weeks."
10900714|NCT00568126|EG001|Reported Event|Placebo|"Subjects in this arm will receive inactive placebo for 12 weeks.~Placebo: Placebo provided by research pharmacy daily for 12 weeks."
10900715|NCT00568321|BG000|Baseline|Placebo|Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).
10900716|NCT00568321|BG001|Baseline|Tanezumab 50 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).
10900717|NCT00568321|BG002|Baseline|Tanezumab 200 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
10900718|NCT00568321|BG003|Baseline|Total|Total of all reporting groups
10900719|NCT00568321|FG000|Participant Flow|Placebo|Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).
10900720|NCT00568321|FG001|Participant Flow|Tanezumab 50 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).
10900721|NCT00568321|FG002|Participant Flow|Tanezumab 200 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
10900722|NCT00568321|OG000|Outcome|Placebo|Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).
10900723|NCT00568321|OG001|Outcome|Tanezumab 50 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).
10900724|NCT00568321|OG002|Outcome|Tanezumab 200 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
10900725|NCT00568321|OG000|Outcome|Tanezumab 50 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).
10900726|NCT00568321|OG001|Outcome|Tanezumab 200 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
10900727|NCT00568321|EG000|Reported Event|Placebo|Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).
10900728|NCT00568321|EG001|Reported Event|Tanezumab 50 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).
10900729|NCT00568321|EG002|Reported Event|Tanezumab 200 mcg/kg|Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
10900730|NCT00568334|BG000|Baseline|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
10900731|NCT00568334|BG001|Baseline|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
10900732|NCT00568334|BG002|Baseline|Total|Total of all reporting groups
10900733|NCT00568334|FG000|Participant Flow|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
10900734|NCT00568334|FG001|Participant Flow|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
10900735|NCT00568334|OG000|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
10900736|NCT00568334|OG001|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
10900737|NCT00568334|EG000|Reported Event|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
10900738|NCT00568334|EG001|Reported Event|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
10900739|NCT00568386|BG000|Baseline|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
10900740|NCT00568386|BG001|Baseline|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
10900741|NCT00568386|BG002|Baseline|Total|Total of all reporting groups
10900742|NCT00568386|FG000|Participant Flow|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
10900743|NCT00568386|FG001|Participant Flow|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
10900744|NCT00568386|OG000|Outcome|Systane Lubricant Eye Drops|Systane lubricant eye drops
10900745|NCT00568386|OG001|Outcome|Optive Lubricant Eye Drops|Optive Lubricant eye drops
10900746|NCT00568386|EG000|Reported Event|Systane Lubricant Eye Drops|Systane lubricant eye drops
10900747|NCT00568386|EG001|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant eye drops
10914841|NCT00633009|FG000|Participant Flow|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. All participants received a placebo skin test concurrently with active drug.
10914842|NCT00633009|FG001|Participant Flow|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
10914843|NCT00633009|FG002|Participant Flow|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
10914844|NCT00633009|OG000|Outcome|15 ug Study Group|
10914845|NCT00633009|OG001|Outcome|30 ug Study Group|
10914846|NCT00633009|OG002|Outcome|50 ug Study Group|
10900748|NCT00568399|BG000|Baseline|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
10900749|NCT00568399|FG000|Participant Flow|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
10900750|NCT00568399|OG000|Outcome|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months
10900751|NCT00568399|EG000|Reported Event|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
10900752|NCT00568451|BG000|Baseline|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
10900753|NCT00568451|BG001|Baseline|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
10900754|NCT00568451|BG002|Baseline|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
10900755|NCT00568451|BG003|Baseline|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
10900756|NCT00568451|BG004|Baseline|Total|Total of all reporting groups
10900757|NCT00568451|FG000|Participant Flow|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
10900758|NCT00568451|FG001|Participant Flow|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
10900759|NCT00568451|FG002|Participant Flow|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
10900760|NCT00568451|FG003|Participant Flow|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
10900761|NCT00568451|OG000|Outcome|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
10900762|NCT00568451|OG001|Outcome|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
10900763|NCT00568451|OG002|Outcome|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
10900764|NCT00568451|OG003|Outcome|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
10900765|NCT00568451|OG000|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
10900766|NCT00568451|EG000|Reported Event|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
10900767|NCT00568451|EG001|Reported Event|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
10900768|NCT00568451|EG002|Reported Event|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
10900769|NCT00568451|EG003|Reported Event|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
10900770|NCT00568555|BG000|Baseline|Low Dose Naltrexone|
10900771|NCT00568555|BG001|Baseline|Placebo - Sugar Pill|
10900772|NCT00568555|BG002|Baseline|Total|Total of all reporting groups
10900773|NCT00568555|FG000|Participant Flow|Low Dose Naltrexone First|Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day.
10900774|NCT00568555|FG001|Participant Flow|Placebo - Sugar Pill First|Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day.
10900775|NCT00568555|OG000|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
10900776|NCT00568555|OG001|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
10900777|NCT00568555|OG000|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
10900778|NCT00568555|OG001|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
10900779|NCT00568555|EG000|Reported Event|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
10900780|NCT00568555|EG001|Reported Event|Placebo - Sugar Pill|All participants during the placebo condition
10900781|NCT00568633|BG000|Baseline|Allo-HSCT + TLI + ATG|"Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:~Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)~Anti-thymocyte globulin (ATG) Days -11 to -7~Methylprednisolone Days -11 to -7~Cyclosporine (CSP) Days -4 to +2~5+ of 6 HLA-matched CD34+ cells on Day 0~Mycophenolate mofetil (MMF), Day 0 to Day +28~Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.~Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV~Cyclosporine (CSP): 6.25 mg/kg twice daily oral~Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral~Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.~Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV"
10900782|NCT00568633|BG001|Baseline|Best Standard Care|"Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:~Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)~Autologous transplantation~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning~Umbilical cord blood transplantation~Haploidentical transplantation~Best standard care: Intervention consist of:~Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)~Autologous transplantation~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning~Umbilical cord blood transplantation~Haploidentical transplantation"
10900783|NCT00568633|BG002|Baseline|Total|Total of all reporting groups
10914847|NCT00633009|OG000|Outcome|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
10914848|NCT00633009|OG001|Outcome|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
11171842|NCT02005601|OG001|Outcome|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
10900784|NCT00568633|FG000|Participant Flow|Allo-HSCT + TLI + ATG|"Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:~Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)~Anti-thymocyte globulin (ATG) Days -11 to -7~Methylprednisolone Days -11 to -7~Cyclosporine (CSP) Days -4 to +2~5+ of 6 HLA-matched CD34+ cells on Day 0~Mycophenolate mofetil (MMF), Day 0 to Day +28~Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.~Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV~Cyclosporine (CSP): 6.25 mg/kg twice daily oral~Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral~Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.~Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV"
10900785|NCT00568633|FG001|Participant Flow|Best Standard Care|"Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:~Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)~Autologous transplantation~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning~Umbilical cord blood transplantation~Haploidentical transplantation~Best standard care: Intervention consist of:~Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)~Autologous transplantation~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning~Umbilical cord blood transplantation~Haploidentical transplantation"
10900786|NCT00568633|OG000|Outcome|Allo-HSCT + TLI + ATG|"Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:~Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)~Anti-thymocyte globulin (ATG) Days -11 to -7~Methylprednisolone Days -11 to -7~Cyclosporine (CSP) Days -4 to +2~5+ of 6 HLA-matched CD34+ cells on Day 0~Mycophenolate mofetil (MMF), Day 0 to Day +28~Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.~Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV~Cyclosporine (CSP): 6.25 mg/kg twice daily oral~Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral~Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.~Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV"
10900787|NCT00568633|OG001|Outcome|Best Standard Care|"Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:~Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)~Autologous transplantation~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning~Umbilical cord blood transplantation~Haploidentical transplantation~Best standard care: Intervention consist of:~Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)~Autologous transplantation~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning~Umbilical cord blood transplantation~Haploidentical transplantation"
10900788|NCT00568633|EG000|Reported Event|Allo-HSCT + TLI + ATG|"Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:~Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)~Anti-thymocyte globulin (ATG) Days -11 to -7~Methylprednisolone Days -11 to -7~Cyclosporine (CSP) Days -4 to +2~5+ of 6 HLA-matched CD34+ cells on Day 0~Mycophenolate mofetil (MMF), Day 0 to Day +28~Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.~Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV~Cyclosporine (CSP): 6.25 mg/kg twice daily oral~Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral~Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.~Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV"
10900789|NCT00568633|EG001|Reported Event|Best Standard Care|"Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:~Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)~Autologous transplantation~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning~Umbilical cord blood transplantation~Haploidentical transplantation~Best standard care: Intervention consist of:~Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)~Autologous transplantation~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning~Umbilical cord blood transplantation~Haploidentical transplantation"
10900790|NCT00568685|BG000|Baseline|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
10900791|NCT00568685|BG001|Baseline|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
10900792|NCT00568685|BG002|Baseline|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
10900793|NCT00568685|BG003|Baseline|Total|Total of all reporting groups
10900794|NCT00568685|FG000|Participant Flow|Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day)|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
10900795|NCT00568685|FG001|Participant Flow|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
11233356|NCT02426918|BG002|Baseline|Vancomycin/Linezolid BID|Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.
11233357|NCT02426918|BG003|Baseline|Total|Total of all reporting groups
11357159|NCT03764449|EG000|Reported Event|Cohort 1 Period 1|Balovaptan was administered at dose level A as a single oral dose. IV infusion of balovaptan was administered after the balovaptan oral dose.
10900796|NCT00568685|FG002|Participant Flow|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
10900797|NCT00568685|OG000|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
10900798|NCT00568685|OG001|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
10900799|NCT00568685|OG002|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
10900800|NCT00568685|OG000|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
10900801|NCT00568685|OG001|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
10900802|NCT00568685|OG002|Outcome|> 0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
10900803|NCT00568685|OG002|Outcome|>0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
10900804|NCT00568685|EG000|Reported Event|Atomoxetine 0.00-0.35 mg/kg/Day|Patients who received the actual dose range listed.
10900805|NCT00568685|EG001|Reported Event|Atomoxetine 0.36-0.85 mg/kg/Day|Patients who received the actual dose range listed.
10900806|NCT00568685|EG002|Reported Event|Atomoxetine >0.85 mg/kg/Day|Patients who received the actual dose range listed.
10900807|NCT00568776|BG000|Baseline|Placebo BID|oral administration for 78 weeks
10900808|NCT00568776|BG001|Baseline|ELND005 250 mg BID|oral administration for 78 weeks
10900809|NCT00568776|BG002|Baseline|ELND005 1000 mg BID|oral administration for 78 weeks
10900810|NCT00568776|BG003|Baseline|ELND005 2000 mg BID|oral administration for 78 weeks
10900811|NCT00568776|BG004|Baseline|Total|Total of all reporting groups
10900812|NCT00568776|FG000|Participant Flow|Placebo BID|oral administration for 78 weeks
10900813|NCT00568776|FG001|Participant Flow|ELND005 250 mg BID|oral administration for 78 weeks
10900814|NCT00568776|FG002|Participant Flow|ELND005 1000 mg BID|oral administration for 78 weeks
10900815|NCT00568776|FG003|Participant Flow|ELND005 2000 mg BID|oral administration for 78 weeks
10900816|NCT00568776|OG000|Outcome|Placebo BID|oral administration for 78 weeks
10900817|NCT00568776|OG001|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
10900818|NCT00568776|OG002|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
10900819|NCT00568776|OG003|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
10900820|NCT00568776|EG000|Reported Event|Placebo BID|oral administration for 78 weeks
10900821|NCT00568776|EG001|Reported Event|ELND005 250 mg BID|oral administration for 78 weeks
10900822|NCT00568776|EG002|Reported Event|ELND005 1000 mg BID|oral administration for 78 weeks
10900823|NCT00568776|EG003|Reported Event|ELND005 2000 mg BID|oral administration for 78 weeks
10914849|NCT00633009|OG002|Outcome|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
10914850|NCT00633009|EG000|Reported Event|15 ug Study Group|
10914851|NCT00633009|EG001|Reported Event|30 ug Study Group|
10914852|NCT00633009|EG002|Reported Event|50 ug Study Group|
10914853|NCT00633022|BG000|Baseline|Losmapimod 7.5 mg Twice Daily|Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
10914854|NCT00633022|BG001|Baseline|Losmapimod 7.5 mg Once Daily|Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
10914855|NCT00633022|BG002|Baseline|Placebo|Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
10914856|NCT00633022|BG003|Baseline|Total|Total of all reporting groups
10914857|NCT00633022|FG000|Participant Flow|Losmapimod 7.5 mg Twice Daily|Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
10914858|NCT00633022|FG001|Participant Flow|Losmapimod 7.5 mg Once Daily|Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
10914859|NCT00633022|FG002|Participant Flow|Placebo|Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
10914860|NCT00633022|OG000|Outcome|Losmapimod 7.5 mg Twice Daily|Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
10914861|NCT00633022|OG001|Outcome|Losmapimod 7.5 mg Once Daily|Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
10914862|NCT00633022|OG002|Outcome|Placebo|Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
10914863|NCT00633022|EG000|Reported Event|Losmapimod 7.5 mg Twice Daily|Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
10914864|NCT00633022|EG001|Reported Event|Losmapimod 7.5 mg Once Daily|Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
10900824|NCT04274192|BG000|Baseline|Synchronized HFNC First|Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
10900825|NCT04274192|BG001|Baseline|Continuous HFNC First|Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
10900826|NCT04274192|BG002|Baseline|Total|Total of all reporting groups
10900827|NCT04274192|FG000|Participant Flow|Synchronized HFNC First|Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
10900828|NCT04274192|FG001|Participant Flow|Continuous HFNC First|Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
10900829|NCT04274192|OG000|Outcome|Synchronized HFNC|"This will be the experimental arm in which subjects will receive HFNC synchronized to his/her own efforts via NAVA~Synchronized HFNC: HFNC given in synchrony with the subject's own respiratory effort using NAVA~Continuous HFNC: Standard HFNC therapy"
10900830|NCT04274192|OG001|Outcome|Continuous HFNC|"This arm will be considered the control arm in which subjects will receive continuous HFNC.~Synchronized HFNC: HFNC given in synchrony with the subject's own respiratory effort using NAVA~Continuous HFNC: Standard HFNC therapy"
10900831|NCT04274192|OG000|Outcome|Synchronized HFNC First|Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
10900832|NCT04274192|OG001|Outcome|Continuous HFNC First|Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
10900833|NCT04274192|EG000|Reported Event|Synchronized HFNC First|Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
10900834|NCT04274192|EG001|Reported Event|Continuous HFNC First|Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
10900835|NCT04200833|BG000|Baseline|Group 1|"All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019~Golimumab: subcutaneous injection"
10900836|NCT04200833|FG000|Participant Flow|Group 1|"All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019~Golimumab: subcutaneous injection"
10900837|NCT04200833|OG000|Outcome|Group 1|"All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019~Golimumab: subcutaneous injection"
10900838|NCT04200833|EG000|Reported Event|Group 1|"All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019~Golimumab: subcutaneous injection"
10900839|NCT04110314|BG000|Baseline|Gain-framed Portal Reminders + Pre-commitment Prompts|"Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Gain-framed: Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
10900840|NCT04110314|BG001|Baseline|Gain-framed Portal Reminders + No Pre-commitment Prompt|"Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Gain-framed: Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination."
11171843|NCT02005601|EG000|Reported Event|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
10900841|NCT04110314|BG002|Baseline|Loss-framed Portal Reminders + Pre-commitment Prompt|"Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Loss-framed: Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
10900842|NCT04110314|BG003|Baseline|Loss-framed Portal Reminders + No Pre-commitment Prompt|"Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Loss-framed: Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination."
10900843|NCT04110314|BG004|Baseline|No Portal Reminder + Pre-commitment Prompt|"Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal but do receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
11171844|NCT02005601|EG001|Reported Event|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
10900844|NCT04110314|BG005|Baseline|No Portal Reminders + No Pre-commitment Prompt|Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal and do not receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season
10900845|NCT04110314|BG006|Baseline|Total|Total of all reporting groups
10900846|NCT04110314|FG000|Participant Flow|Gain-framed Portal Reminders + Pre-commitment Prompts|"Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Gain-framed: Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
10900847|NCT04110314|FG001|Participant Flow|Gain-framed Portal Reminders + No Pre-commitment Prompt|"Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Gain-framed: Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination."
10900848|NCT04110314|FG002|Participant Flow|Loss-framed Portal Reminders + Pre-commitment Prompt|"Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Loss-framed: Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
10900849|NCT04110314|FG003|Participant Flow|Loss-framed Portal Reminders + No Pre-commitment Prompt|"Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Loss-framed: Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination."
10900850|NCT04110314|FG004|Participant Flow|No Portal Reminder + Pre-commitment Prompt|"Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal but do receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
11357160|NCT03764449|EG001|Reported Event|Cohort 1, Period 2|Balovaptan was administered at dose level A as an oral dose once daily on Day 1 to Day 14. IV infusion of balovaptan was administered after the final oral dose of balovaptan.
10900851|NCT04110314|FG005|Participant Flow|No Portal Reminders + No Pre-commitment Prompt|Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal and do not receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season
10900852|NCT04110314|OG000|Outcome|Young Adults 18-64yr Without Diabetes|Participants ages 18-64 Without Diabetes
10900853|NCT04110314|OG001|Outcome|Older Adults Greater Than or Equal to 65 yr Without Diabetes|Older adults with diabetes greater than or equal to 65 years without diabetes.
10900854|NCT04110314|OG002|Outcome|Adults 18years or Older With Diabetes|Adults 18 years or older with Diabetes
10900855|NCT04110314|OG003|Outcome|Children <18y|Participants age <18
10900856|NCT04110314|EG000|Reported Event|Gain-framed Portal Reminders + Pre-commitment Prompts|"Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Gain-framed: Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
10900857|NCT04110314|EG001|Reported Event|Gain-framed Portal Reminders + No Pre-commitment Prompt|"Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Gain-framed: Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination."
10900858|NCT04110314|EG002|Reported Event|Loss-framed Portal Reminders + Pre-commitment Prompt|"Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Loss-framed: Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
10900859|NCT04110314|EG003|Reported Event|Loss-framed Portal Reminders + No Pre-commitment Prompt|"Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Portal Reminders for Influenza Vaccination: Loss-framed: Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination."
10900860|NCT04110314|EG004|Reported Event|No Portal Reminder + Pre-commitment Prompt|"Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal but do receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season~Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination"
11357161|NCT03764449|EG002|Reported Event|Cohort 2, Period 1|Balovaptan was administered as a single oral dose at dose level B. IV infusion of balovaptan was administered after the balovaptan oral dose.
11357162|NCT03764449|EG003|Reported Event|Cohort 2, Period 2|Balovaptan was administered at Dose level B as an oral dose once daily on Day 1 to Day 14. IV infusion of balovaptan was administered after the final oral dose of balovaptan.
10900861|NCT04110314|EG005|Reported Event|No Portal Reminders + No Pre-commitment Prompt|Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal and do not receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season
10900862|NCT04086472|BG000|Baseline|MK-1654 100 mg|Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
10900863|NCT04086472|BG001|Baseline|MK-1654 200 mg|Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
10900864|NCT04086472|BG002|Baseline|MK-1654 300 mg|Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
11171845|NCT02005627|BG000|Baseline|Grazax|The active treatment arm received active grass pollen immunotherapy tablet, Grazax Oral Lyophilisate 75,000 standardised quality units tablet once daily.
11171846|NCT02005627|BG001|Baseline|Grazax Placebo|This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
11171847|NCT02005627|BG002|Baseline|Total|Total of all reporting groups
10900865|NCT04086472|BG003|Baseline|MK-1654 900 mg|Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
10900866|NCT04086472|BG004|Baseline|Placebo|Participants receive a single IV infusion of placebo on Day 1.
10900867|NCT04086472|BG005|Baseline|Total|Total of all reporting groups
10900868|NCT04086472|FG000|Participant Flow|MK-1654 100 mg|Participants receive a single intravenous (IV) infusion of MK-1654 100 mg on Day 1.
10900869|NCT04086472|FG001|Participant Flow|MK-1654 200 mg|Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
10900870|NCT04086472|FG002|Participant Flow|MK-1654 300 mg|Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
10900871|NCT04086472|FG003|Participant Flow|MK-1654 900 mg|Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
10900872|NCT04086472|FG004|Participant Flow|Placebo|Participants receive a single IV infusion of placebo on Day 1.
10900873|NCT04086472|OG000|Outcome|MK-1654 100 mg|Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
10900874|NCT04086472|OG001|Outcome|MK-1654 200 mg|Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
10900875|NCT04086472|OG002|Outcome|MK-1654 300 mg|Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
10900876|NCT04086472|OG003|Outcome|MK-1654 900 mg|Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
10900877|NCT04086472|OG004|Outcome|Placebo|Participants receive a single IV infusion of placebo on Day 1.
10900878|NCT04086472|EG000|Reported Event|MK-1654 100 mg|Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
10900879|NCT04086472|EG001|Reported Event|MK-1654 200 mg|Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
10900880|NCT04086472|EG002|Reported Event|MK-1654 300 mg|Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
10900881|NCT04086472|EG003|Reported Event|MK-1654 900 mg|Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
10900882|NCT04086472|EG004|Reported Event|Placebo|Participants receive a single IV infusion of placebo on Day 1.
10900883|NCT04084288|BG000|Baseline|Postoperative Acupuncture|"Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request.~A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room.~A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon)~Acupuncture: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed"
10900884|NCT04084288|FG000|Participant Flow|Postoperative Acupuncture|"Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request.~A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room.~A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon)~Acupuncture: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed"
10900885|NCT04084288|OG000|Outcome|Postoperative Acupuncture|"Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request.~A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room.~A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon)~Acupuncture: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed"
10914865|NCT00633022|EG002|Reported Event|Placebo|Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
10914866|NCT00633074|BG000|Baseline|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
11171848|NCT02005627|FG000|Participant Flow|Grazax|"The active treatment arm received active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 standardised quality units tablet (SQ-T) once daily.~Grazax: The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily."
10914867|NCT00633074|BG001|Baseline|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
10914868|NCT00633074|BG002|Baseline|Total|Total of all reporting groups
10900886|NCT04084288|OG000|Outcome|Postoperative Acupuncture|Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request. A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon) Acupuncture: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed Peripheral Nerve Stimulator: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus).
10900887|NCT04084288|OG000|Outcome|Side Effects in the Past 24 hs POD 1|for POD 1, In the last 24 hours, have you had any nausea, vomiting, constipation, difficulty passing urine, concentrating, staying awake, lightheaded/dizzy, confused, general fatigue, itchiness, dry mouth, headache?
10900888|NCT04084288|OG001|Outcome|Side Effects PACU|Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
10900889|NCT04084288|OG000|Outcome|Knee Range of Motion (ROM) at 6 Weeks|Range of motion at 6 weeks F/U for surgery
10900890|NCT04084288|OG000|Outcome|Tourniquet Intra-operative|Length of tourniquet time during intra-operative
10900891|NCT04084288|EG000|Reported Event|Postoperative Acupuncture|"Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request.~A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room.~A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon)~Acupuncture: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed"
10914869|NCT00633074|FG000|Participant Flow|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
10914870|NCT00633074|FG001|Participant Flow|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
10914871|NCT00633074|OG000|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
10914872|NCT00633074|OG001|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
10914873|NCT00633074|EG000|Reported Event|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
10914874|NCT00633074|EG001|Reported Event|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
10914875|NCT00633126|BG000|Baseline|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
10914876|NCT00633126|FG000|Participant Flow|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
10914877|NCT00633126|OG000|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
10914878|NCT00633126|EG000|Reported Event|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
10914879|NCT00633139|BG000|Baseline|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
10914880|NCT00633139|BG001|Baseline|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
10914881|NCT00633139|BG002|Baseline|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
10914882|NCT00633139|BG003|Baseline|Total|Total of all reporting groups
10914883|NCT00633139|FG000|Participant Flow|Cohort 1|Participants received a single dose of rhASA at 25 units per kilogram (U/kg) intravenous (IV) infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
10914884|NCT00633139|FG001|Participant Flow|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
10914885|NCT00633139|FG002|Participant Flow|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
10914886|NCT00633139|OG000|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
10914887|NCT00633139|OG001|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
10900892|NCT03961204|BG000|Baseline|Cohort A|Participants previously enrolled in parent studies CLARITY (NCT00213135), CLARITY-EXT (NCT00641537), ORACLE (NCT00725985) and had received Cladribine tablet and Placebo were invited up to 2 visit for follow-up/data collection.
10900893|NCT03961204|FG000|Participant Flow|Cohort A|Participants previously enrolled in parent studies CLARITY (NCT00213135), CLARITY-EXT (NCT00641537), ORACLE (NCT00725985) and had received Cladribine tablet and Placebo were invited up to 2 visit for follow-up/data collection.
10900894|NCT03961204|OG000|Outcome|Cohort A|Participants previously enrolled in parent studies CLARITY (NCT00213135), CLARITY-EXT (NCT00641537), ORACLE (NCT00725985) and had received Cladribine tablet and Placebo were invited up to 2 visit for follow-up/data collection.
10900895|NCT03961204|EG000|Reported Event|Cohort A|Participants previously enrolled in parent studies CLARITY (NCT00213135), CLARITY-EXT (NCT00641537), ORACLE (NCT00725985) and had received Cladribine tablet and Placebo were invited up to 2 visit for follow-up/data collection.
10900896|NCT03895840|BG000|Baseline|Intra-articular Zilretta Injection|"32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines~Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis."
10900897|NCT03895840|FG000|Participant Flow|Intra-articular Zilretta Injection|"32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines~Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis."
10900898|NCT03895840|OG000|Outcome|Intra-articular Zilretta Injection|"32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines~Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis."
10900899|NCT03895840|EG000|Reported Event|Intra-articular Zilretta Injection|"32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines~Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis."
10900900|NCT03818399|BG000|Baseline|Overdose Patients|"subjects that receive acute administration of SUBOXONE sublingual film in the ED followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, and receive monthly SUBLOCADE injections for 6 months in the context of outpatient treatment.~SUBLOCADE: SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at a controlled rate over a one-month period."
10900901|NCT03818399|FG000|Participant Flow|Overdose Patients|"subjects that receive acute administration of SUBOXONE sublingual film in the ED followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, and receive monthly SUBLOCADE injections for 6 months in the context of outpatient treatment.~SUBLOCADE: SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at a controlled rate over a one-month period."
10900902|NCT03818399|OG000|Outcome|Overdose Patients|"subjects that receive acute administration of SUBOXONE sublingual film in the ED followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, and receive monthly SUBLOCADE injections for 6 months in the context of outpatient treatment.~SUBLOCADE: SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at a controlled rate over a one-month period."
10900903|NCT03818399|EG000|Reported Event|Overdose Patients|"subjects that receive acute administration of SUBOXONE sublingual film in the ED followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, and receive monthly SUBLOCADE injections for 6 months in the context of outpatient treatment.~SUBLOCADE: SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at a controlled rate over a one-month period."
10900904|NCT03603496|BG000|Baseline|Transitional Tobacco Care Management (TTCM)|"TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.~Transitional Tobacco Care Management (TTCM): PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.~Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient."
10900905|NCT03603496|BG001|Baseline|eReferral to State Tobacco Quitline (QL)|"Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.~eReferral to State Tobacco Quitline (QL): Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.~Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient."
10900906|NCT03603496|BG002|Baseline|Total|Total of all reporting groups
10914888|NCT00633139|OG002|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
10914889|NCT00633139|EG000|Reported Event|Cohort 1|Cohort 1: Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
10900907|NCT03603496|FG000|Participant Flow|Transitional Tobacco Care Management (TTCM)|"TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.~Transitional Tobacco Care Management (TTCM): TTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.~Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient."
10900908|NCT03603496|FG001|Participant Flow|eReferral to State Tobacco Quitline (QL)|"Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.~eReferral to State Tobacco Quitline (QL): Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.~Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient."
10900909|NCT03603496|OG000|Outcome|Transitional Tobacco Care Management (TTCM)|"TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.~Transitional Tobacco Care Management (TTCM): TTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.~Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient."
10900910|NCT03603496|OG001|Outcome|eReferral to State Tobacco Quitline (QL)|"Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.~eReferral to State Tobacco Quitline (QL): Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.~Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient."
10900911|NCT03603496|EG000|Reported Event|Transitional Tobacco Care Management (TTCM)|"TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.~Transitional Tobacco Care Management (TTCM): TTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.~Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient."
10900912|NCT03603496|EG001|Reported Event|eReferral to State Tobacco Quitline (QL)|"Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.~eReferral to State Tobacco Quitline (QL): Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.~Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient."
10914890|NCT00633139|EG001|Reported Event|Cohort 2|Cohort 2: Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
10914891|NCT00633139|EG002|Reported Event|Cohort 3|Cohort 3: Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
10914892|NCT00633152|BG000|Baseline|Ceftaroline|Intramuscular every 12 hours
10914893|NCT00633152|BG001|Baseline|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
10914894|NCT00633152|BG002|Baseline|Total|Total of all reporting groups
10914895|NCT00633152|FG000|Participant Flow|Ceftaroline|Intramuscular every 12 hours
10914896|NCT00633152|FG001|Participant Flow|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
10914897|NCT00633152|OG000|Outcome|Ceftaroline|Ceftaroline was administered 600 mg as an Intramuscular injection every 12 hours
10914898|NCT00633152|OG001|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg Intravenous infusions over 60 minutes every 12 hours
10914899|NCT00633152|OG000|Outcome|Ceftaroline|Ceftaroline fosamil was administered 600mg IM every 12 hours
10914900|NCT00633152|OG001|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg IV infusions over 60 minutes q12h
10914901|NCT00633152|EG000|Reported Event|Ceftaroline|Intramuscular every 12 hours
10914902|NCT00633152|EG001|Reported Event|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
10914903|NCT00633217|BG000|Baseline|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
10900913|NCT03480802|BG000|Baseline|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
10900914|NCT03480802|BG001|Baseline|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
10900915|NCT03480802|BG002|Baseline|Total|Total of all reporting groups
10900916|NCT03480802|FG000|Participant Flow|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
10914904|NCT00633217|BG001|Baseline|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
10900917|NCT03480802|FG001|Participant Flow|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
10900918|NCT03480802|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
10900919|NCT03480802|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
10900920|NCT03480802|EG000|Reported Event|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1).
10900921|NCT03480802|EG001|Reported Event|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1).
10900922|NCT03480802|EG002|Reported Event|V114 (Post-PPV23)|Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 (PPV23) at Week 8 (Vaccination 2).
10900923|NCT03480802|EG003|Reported Event|Prevnar 13™ (Post-PPV23)|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PPV23 at Week 8 (Vaccination 2).
10900924|NCT03472521|BG000|Baseline|Gabapentin|Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
10900925|NCT03472521|BG001|Baseline|Control|Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
10900926|NCT03472521|BG002|Baseline|Total|Total of all reporting groups
10900927|NCT03472521|FG000|Participant Flow|Gabapentin|Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
10900928|NCT03472521|FG001|Participant Flow|Control|Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
10900929|NCT03472521|OG000|Outcome|Gabapentin|Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
10900930|NCT03472521|OG001|Outcome|Control|Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
10900931|NCT03472521|EG000|Reported Event|Gabapentin|"Gabapentin 300 mg capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.~Gabapentin: Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration."
10900932|NCT03472521|EG001|Reported Event|Control|"Matched placebo capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.~Placebo: Placebo to match gabapentin"
10900942|NCT03303950|BG000|Baseline|All Participants - Treatment|Participants receive busulfan IV over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Participants undergo hematopoietic stem cell transplant (HSCT) on day 0. Participants then receive cyclophosphamide IV over 60 minutes on days 3 and 4.
10900943|NCT03303950|FG000|Participant Flow|All Particpants - Treatment|Participants receive busulfan IV over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Participants undergo hematopoietic stem cell transplant (HSCT) on day 0. Participants then receive cyclophosphamide IV over 60 minutes on days 3 and 4.
10900944|NCT03303950|OG000|Outcome|All Participants - Treatment|Participants receive busulfan IV over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Participants undergo hematopoietic stem cell transplant (HSCT) on day 0. Participants then receive cyclophosphamide IV over 60 minutes on days 3 and 4.
10900945|NCT03303950|OG000|Outcome|All Particpants - Treatment|Participants receive busulfan IV over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Participants undergo hematopoietic stem cell transplant (HSCT) on day 0. Participants then receive cyclophosphamide IV over 60 minutes on days 3 and 4.
10900946|NCT03303950|EG000|Reported Event|All Participants - Treatment|Participants receive busulfan IV over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Participants undergo hematopoietic stem cell transplant (HSCT) on day 0. Participants then receive cyclophosphamide IV over 60 minutes on days 3 and 4.
10900947|NCT02673203|BG000|Baseline|Typical Weight Participants|Participants with a BMI <25 kg/m2.
10900948|NCT02673203|BG001|Baseline|Obese Non-diabetic Pariticpants|Non-diabetic participants with a BMI > 30 kg/m2.
10900949|NCT02673203|BG002|Baseline|Total|Total of all reporting groups
10900950|NCT02673203|FG000|Participant Flow|Typical Weight Participants|Participants with a BMI <25 kg/m2.
10900951|NCT02673203|FG001|Participant Flow|Obese Non-diabetic Pariticpants|Non-diabetic participants with a BMI > 30 kg/m2.
10900952|NCT02673203|OG000|Outcome|Typical Weight Participants|Participants with a BMI <25 kg/m2.
10900953|NCT02673203|OG001|Outcome|Obese Non-diabetic Pariticpants|Non-diabetic participants with a BMI > 30 kg/m2.
10900954|NCT02673203|EG000|Reported Event|Typical Weight Participants|Participants with a BMI <25 kg/m2.
10900955|NCT02673203|EG001|Reported Event|Obese Non-diabetic Pariticpants|Non-diabetic participants with a BMI > 30 kg/m2.
10900956|NCT02664441|BG000|Baseline|Exenatide Once Weekly Extended-release|"Injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention followed by 18 weeks open label exenatide once weekly extended-release.~Exenatide: Weekly injections of active drug."
10900957|NCT02664441|BG001|Baseline|Matching Placebo|"Weekly injections of placebo for 36 weeks followed by 18 weeks open label exenatide once weekly extended-release.~placebo: Weekly placebo injections"
10900958|NCT02664441|BG002|Baseline|Total|Total of all reporting groups
10900959|NCT02664441|FG000|Participant Flow|Exenatide Once Weekly Extended-release|"Injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention followed by 18 weeks open label exenatide once weekly extended-release.~Exenatide: Weekly injections of active drug."
10900960|NCT02664441|FG001|Participant Flow|Matching Placebo|"Weekly injections of placebo for 36 weeks followed by 18 weeks open label exenatide once weekly extended-release.~placebo: Weekly placebo injections"
10900961|NCT02664441|OG000|Outcome|Exenatide Once Weekly Extended-release|"Injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention followed by 18 weeks open label exenatide once weekly extended-release.~Exenatide: Weekly injections of active drug."
10900962|NCT02664441|OG001|Outcome|Matching Placebo|"Weekly injections of placebo for 36 weeks followed by 18 weeks open label exenatide once weekly extended-release.~placebo: Weekly placebo injections"
10900963|NCT02664441|EG000|Reported Event|Double-Blind Exenatide Once Weekly Extended-release|"Injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention~Exenatide: Weekly injections of active drug."
10900964|NCT02664441|EG001|Reported Event|Double-Blind Placebo|"Weekly injections of placebo for 36 weeks in randomized intervention~placebo: Weekly placebo injections"
10900965|NCT02664441|EG002|Reported Event|Open Label Exenatide Once Weekly Extended-release|"18 weeks open label exenatide once weekly extended-release (Bydureon®) arm.~Exenatide: Weekly injections of active drug."
10914905|NCT00633217|BG002|Baseline|Total|Total of all reporting groups
10914906|NCT00633217|FG000|Participant Flow|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
10914907|NCT00633217|FG001|Participant Flow|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
10914908|NCT00633217|OG000|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
10914909|NCT00633217|OG001|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
10914910|NCT00633217|EG000|Reported Event|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
10914911|NCT00633217|EG001|Reported Event|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
10914912|NCT00633243|BG000|Baseline|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
10914913|NCT00633243|BG001|Baseline|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
10914914|NCT00633243|BG002|Baseline|Total|Total of all reporting groups
10914915|NCT00633243|FG000|Participant Flow|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning weight-based ribavirin (RBV) dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. Pegylated interferon alfa-2a(PEG) was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
10914916|NCT00633243|FG001|Participant Flow|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the pegylated interferon alfa-a (PEG) and weight-based ribavirin (RBV). Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
10914917|NCT00633243|OG000|Outcome|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
11233358|NCT02426918|FG000|Participant Flow|Debio 1450 80 mg (Milligrams)/120 mg BID|Debio 1450 80 mg was administered intravenously twice daily (BID). After 2 doses of Debio 1450 intravenous (IV) therapy, Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.
11171849|NCT02005627|FG001|Participant Flow|Grazax Placebo|"This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.~Grazax Placebo: This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract."
11171850|NCT02005627|OG000|Outcome|Grazax|The active treatment arm received active grass pollen immunotherapy tablet, Grazax Oral Lyophilisate 75,000 standardised quality units tablet once daily.
11171851|NCT02005627|OG001|Outcome|Grazax Placebo|This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
11171852|NCT02005627|OG001|Outcome|Grazax Placebo|This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
10900966|NCT02527187|BG000|Baseline|Allergic Patients to Birch Pollen|"Allergic patients already diagnosed to be true allergic to birch pollen.~A mean wheal diameter >3 mm obtained in a prick test with histamine dihydrochloride 10 mg/ml.Also presence of serum specific IgE and clinical history of symptomatology related to exposure to birch pollen.~Patients of both gender aged from 5 up to 70 years."
10900967|NCT02527187|BG001|Baseline|Non-allergic Patients to Birch Pollen|"Patients already diagnosed to be true non-allergic to birch pollen.~Non clinical history of symptomatology related to the exposure to birch pollen. Previous skin prick test negative and absence or undetectable serum specific IgE to Betula verrucosa~Patients of both gender aged from 5 up to 70 years."
10900968|NCT02527187|BG002|Baseline|Total|Total of all reporting groups
11171853|NCT02005627|EG000|Reported Event|Grazax|"The active treatment arm received active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 standardised quality units tablet (SQ-T) once daily.~Grazax: The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily."
11171854|NCT02005627|EG001|Reported Event|Grazax Placebo|"This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.~Grazax Placebo: This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract."
11171855|NCT02005666|BG000|Baseline|Test-Cadila Healthcare Limited|1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11171856|NCT02005666|BG001|Baseline|Reference-DUAC® Gel|DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11171857|NCT02005666|BG002|Baseline|Placebo|Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11171858|NCT02005666|BG003|Baseline|Total|Total of all reporting groups
11171859|NCT02005666|FG000|Participant Flow|Test-Cadila Healthcare Limited|1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
10900969|NCT02527187|FG000|Participant Flow|Allergic Patients to Birch Pollen|"Allergic patients already diagnosed to be true allergic to birch pollen.~A mean wheal diameter >3 mm obtained in a prick test with histamine dihydrochloride 10 mg/ml.Also presence of serum specific IgE and clinical history of symptomatology related to exposure to birch pollen.~Patients of both gender aged from 5 up to 70 years."
11171860|NCT02005666|FG001|Participant Flow|Reference-DUAC® Gel|DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11171861|NCT02005666|FG002|Participant Flow|Placebo|Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11171862|NCT02005666|OG000|Outcome|Test-Cadila Healthcare Limited|1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11171863|NCT02005666|OG001|Outcome|Reference-DUAC® Gel|DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
10900970|NCT02527187|FG001|Participant Flow|Non-allergic Patients to Birch Pollen|"Patients already diagnosed to be true non-allergic to birch pollen.~Non clinical history of symptomatology related to the exposure to birch pollen. Previous skin prick test negative and absence or undetectable serum specific IgE to Betula verrucosa~Patients of both gender aged from 5 up to 70 years."
10900971|NCT02527187|OG000|Outcome|Allergic Patients to Birch Pollen|"Allergic patients already diagnosed to be true allergic to birch pollen.~A mean wheal diameter >3 mm obtained in a prick test with histamine dihydrochloride 10 mg/ml.Also presence of serum specific IgE and clinical history of symptomatology related to exposure to birch pollen.~Patients of both gender aged from 5 up to 70 years."
10900972|NCT02527187|OG001|Outcome|Non-allergic Patients to Birch Pollen|"Patients already diagnosed to be true non-allergic to birch pollen.~Non clinical history of symptomatology related to the exposure to birch pollen. Previous skin prick test negative and absence or undetectable serum specific IgE to Betula verrucosa~Patients of both gender aged from 5 up to 70 years."
10900973|NCT02527187|OG000|Outcome|Allergic Patients to Birch Pollen|"Allergic patients already diagnosed to be true allergic to birch pollen.~A mean wheal diameter >3 mm obtained in a prick test with histamine dihydrochloride 10 mg/ml.Also presence of serum specific IgE and clinical history of symptomatology related to exposure to birch pollen.~Patients of both gender aged from 5 up to 70 years.~The investigational product contained the allergen extract of the pollen of Betula verrucosa and will be tested by administration onto skin. The test will be carried out on the forearm following prick test technique."
11171864|NCT02005666|OG002|Outcome|Placebo|Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11171865|NCT02005666|EG000|Reported Event|Test-Cadila Healthcare Limited|1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days Other Name: 1.2% Clindamycin Phosphate/ 5%
10900974|NCT02527187|OG001|Outcome|Non-allergic Patients to Birch Pollen|"Patients already diagnosed to be true non-allergic to birch pollen.~Non clinical history of symptomatology related to the exposure to birch pollen. Previous skin prick test negative and absence or undetectable serum specific IgE to Betula verrucosa~Patients of both gender aged from 5 up to 70 years.~The investigational product contained the allergen extract of the pollen of Betula verrucosa and will be tested by administration onto skin. The test will be carried out on the forearm following prick test technique."
10900975|NCT02527187|EG000|Reported Event|Allergic Patients to Birch Pollen|"Allergic patients already diagnosed to be true allergic to birch pollen.~A mean wheal diameter >3 mm obtained in a prick test with histamine dihydrochloride 10 mg/ml.Also presence of serum specific IgE and clinical history of symptomatology related to exposure to birch pollen.~Patients of both gender aged from 5 up to 70 years."
10900976|NCT02527187|EG001|Reported Event|Non-allergic Patients to Birch Pollen|"Patients already diagnosed to be true non-allergic to birch pollen.~Non clinical history of symptomatology related to the exposure to birch pollen. Previous skin prick test negative and absence or undetectable serum specific IgE to Betula verrucosa~Patients of both gender aged from 5 up to 70 years."
10900977|NCT02513472|BG000|Baseline|Stratum 1: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC who were never treated with systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1.
10900978|NCT02513472|BG001|Baseline|Stratum 2: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 2.
10900979|NCT02513472|BG002|Baseline|Total|Total of all reporting groups
10900980|NCT02513472|FG000|Participant Flow|Stratum 1: Eribulin Mesylate + Pembrolizumab|Participants with metastatic triple negative breast cancer (mTNBC) who were never treated with systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 milligram per square meter (mg/m^2), intravenous infusion on Days 1 and 8 and pembrolizumab 200 milligram (mg), intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1.
10900981|NCT02513472|FG001|Participant Flow|Stratum 2: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 2.
10900982|NCT02513472|OG000|Outcome|Stratum 1: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC who were never treated with systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1.
10900983|NCT02513472|OG001|Outcome|Stratum 2: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 2.
10900984|NCT02513472|OG002|Outcome|Overall: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC who were never treated with systemic anticancer therapy and previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1 and 2.
10900985|NCT02513472|EG000|Reported Event|Stratum 1: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC who were never treated with systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1.
11171866|NCT02005666|EG001|Reported Event|Reference-DUAC® Gel|DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11357163|NCT03763929|BG000|Baseline|Trans Sodium Crocetinate|"Trans sodium crocetinate (TSC) will be administered intravenously as a bolus to subjects randomized to experimental drug. The bolus dose will consist of 0.25 mg/kg of TSC based on the estimated subject weight.~Trans-Sodium Crocetinate: In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance."
10900986|NCT02513472|EG001|Reported Event|Stratum 2: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 2.
10900987|NCT02513472|EG002|Reported Event|Overall: Eribulin Mesylate + Pembrolizumab|Participants with mTNBC who were never treated with systemic anticancer therapy and previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1 and 2.
10900988|NCT02476409|BG000|Baseline|Tolvaptan|"Augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily~Tolvaptan: Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure."
10900989|NCT02476409|BG001|Baseline|Placebo|"Augmentation of current dose of loop diuretic~Placebo: Placebo for tolvaptan"
10900990|NCT02476409|BG002|Baseline|Total|Total of all reporting groups
10900991|NCT02476409|FG000|Participant Flow|Tolvaptan|"Augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily~Tolvaptan: Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure."
10900992|NCT02476409|FG001|Participant Flow|Placebo|"Augmentation of current dose of loop diuretic~Placebo: Placebo for tolvaptan"
10900993|NCT02476409|OG000|Outcome|Tolvaptan|"Augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily~Tolvaptan: Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure."
10900994|NCT02476409|OG001|Outcome|Placebo|"Augmentation of current dose of loop diuretic~Placebo: Placebo for tolvaptan"
11171867|NCT02005666|EG002|Reported Event|Placebo|Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
11171868|NCT02005692|BG000|Baseline|DynaSense Sensor|All subjects who successfully completed the study.
10900995|NCT02476409|OG000|Outcome|High Copeptin - Tolvaptan|"High Copeptin (≥ 20 pmol/L) Tolvaptan (augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily)~Tolvaptan: Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure."
10900996|NCT02476409|OG001|Outcome|High Copeptin - Placebo|"High Copeptin (≥ 20 pmol/L) Placebo (augmentation of current dose of loop diuretic)~Placebo: Placebo for tolvaptan"
10900997|NCT02476409|OG002|Outcome|Low Copeptin - Tolvaptan|Low Copeptin (< 20 pmol/L) Tolvaptan (augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily)
11171869|NCT02005692|FG000|Participant Flow|DynaSense Sensor|"All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.~The rate of compliance with prescribed turning protocols was measured using the DynaSense System."
10900998|NCT02476409|OG003|Outcome|Low Copeptin - Placebo|"Low Copeptin (< 20 pmol/L) Placebo (augmentation of current dose of loop diuretic)~Placebo: Placebo for tolvaptan"
10900999|NCT02476409|EG000|Reported Event|Tolvaptan|"Augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily~Tolvaptan: Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure."
11171870|NCT02005692|OG000|Outcome|DynaSense Sensor|All subjects enrolled in the study.
10901000|NCT02476409|EG001|Reported Event|Placebo|"Augmentation of current dose of loop diuretic~Placebo: Placebo for tolvaptan"
10901001|NCT02132650|BG000|Baseline|Accurate Walking Training|"Rehabilitation of walking using accurate (ACC) walking tasks~ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc."
10901002|NCT02132650|BG001|Baseline|Steady State Walking Training|"Rehabilitation of walking using typical steady state (SS) walking~SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour."
10901003|NCT02132650|BG002|Baseline|Total|Total of all reporting groups
10901004|NCT02132650|FG000|Participant Flow|Accurate Walking Training|"Rehabilitation of walking using accurate (ACC) walking tasks~ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc."
10901005|NCT02132650|FG001|Participant Flow|Steady State Walking Training|"Rehabilitation of walking using typical steady state (SS) walking~SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour."
10901006|NCT02132650|OG000|Outcome|Accurate Walking Training|"Rehabilitation of walking using accurate (ACC) walking tasks~ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc."
11171871|NCT02005692|OG000|Outcome|DynaSense Sensor|All subjects who successfully completed the study.
11171872|NCT02005692|EG000|Reported Event|DynaSense Sensor|All subjects enrolled in the study.
11171873|NCT02005887|BG000|Baseline|Arm A: Triptorelin + Letrozol|"Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles~Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)~Letrozole: Letrozole 2.5 mg orally every day for 6 cycles"
11233359|NCT02426918|FG001|Participant Flow|Debio 1450 160 mg/240 mg BID|Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.
10901007|NCT02132650|OG001|Outcome|Steady State Walking Training|"Rehabilitation of walking using typical steady state (SS) walking~SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour."
10901008|NCT02132650|EG000|Reported Event|Accurate Walking Training|"Rehabilitation of walking using accurate (ACC) walking tasks~ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc."
10901009|NCT02132650|EG001|Reported Event|Steady State Walking Training|"Rehabilitation of walking using typical steady state (SS) walking~SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour."
10901010|NCT01980355|BG000|Baseline|Tranexamic Acid|"1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery.~Tranexamic Acid"
10901011|NCT01980355|BG001|Baseline|Placebo|"Placebo given over 15 minutes into the vein once prior to surgery.~Placebo"
10901012|NCT01980355|BG002|Baseline|Total|Total of all reporting groups
10901013|NCT01980355|FG000|Participant Flow|Tranexamic Acid|"1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery.~Tranexamic Acid"
10901014|NCT01980355|FG001|Participant Flow|Placebo|"Placebo given over 15 minutes into the vein once prior to surgery.~Placebo"
10901015|NCT01980355|OG000|Outcome|Tranexamic Acid|"1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery.~Tranexamic Acid"
10901016|NCT01980355|OG001|Outcome|Placebo|"Placebo given over 15 minutes into the vein once prior to surgery.~Placebo"
11171874|NCT02005887|BG001|Baseline|Arm B: Degarelix + Letrozol|"Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles~Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)~Letrozole: Letrozole 2.5 mg orally every day for 6 cycles"
11171875|NCT02005887|BG002|Baseline|Total|Total of all reporting groups
11171876|NCT02005887|FG000|Participant Flow|Arm A: Triptorelin + Letrozol|"Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles~Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)~Letrozole: Letrozole 2.5 mg orally every day for 6 cycles"
11171877|NCT02005887|FG001|Participant Flow|Arm B: Degarelix + Letrozol|"Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles~Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)~Letrozole: Letrozole 2.5 mg orally every day for 6 cycles"
10901017|NCT01980355|EG000|Reported Event|Tranexamic Acid|"1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery.~Tranexamic Acid"
11171878|NCT02005887|OG000|Outcome|Arm A: Triptorelin + Letrozol|"Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles~Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)~Letrozole: Letrozole 2.5 mg orally every day for 6 cycles"
11171879|NCT02005887|OG001|Outcome|Arm B: Degarelix + Letrozol|"Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles~Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)~Letrozole: Letrozole 2.5 mg orally every day for 6 cycles"
11171880|NCT02005887|EG000|Reported Event|Arm A: Triptorelin + Letrozol|"Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles~Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)~Letrozole: Letrozole 2.5 mg orally every day for 6 cycles"
11171881|NCT02005887|EG001|Reported Event|Arm B: Degarelix + Letrozol|"Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles~Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)~Letrozole: Letrozole 2.5 mg orally every day for 6 cycles"
11171882|NCT02006056|BG000|Baseline|Primary Prophylaxis|Patients had no nausea or vomiting at baseline.
11171883|NCT02006056|BG001|Baseline|Secondary Prophylaxis|Patients had nausea or vomiting at baseline.
10901018|NCT01980355|EG001|Reported Event|Placebo|"Placebo given over 15 minutes into the vein once prior to surgery.~Placebo"
10901019|NCT01559935|BG000|Baseline|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
11171884|NCT02006056|BG002|Baseline|Total|Total of all reporting groups
10901020|NCT01559935|FG000|Participant Flow|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
11171885|NCT02006056|FG000|Participant Flow|Primary Prophylaxis|Patients have no pre-existing nausea or vomiting 24 hours before radiotherapy
11171886|NCT02006056|FG001|Participant Flow|Secondary Prophylaxis|Patients already experiencing mild nausea and/or mild vomiting within 24 hours before radiotherapy.
11171887|NCT02006056|OG000|Outcome|Primary Prophylaxis|Patients had no nausea or vomiting at baseline.
11171888|NCT02006056|OG001|Outcome|Secondary Prophylaxis|Patients had nausea or vomiting at baseline.
11171889|NCT02006056|OG000|Outcome|C15-PAL Results|C15-PAL results
11171890|NCT02006056|EG000|Reported Event|Ondissolve|"Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.~Ondissolve: Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.~Palliative Radiation Therapy: Patient will receive palliative radiation therapy considered emetogenic for bone metastases."
11171891|NCT02006108|BG000|Baseline|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
11171892|NCT02006108|FG000|Participant Flow|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
11171893|NCT02006108|OG000|Outcome|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
10914918|NCT00633243|OG001|Outcome|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
11171894|NCT02006108|EG000|Reported Event|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
11171895|NCT02006121|BG000|Baseline|Apomorphine Hydrochloride|Apo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe
11171896|NCT02006121|BG001|Baseline|Placebo|Placebo: saline infusion Sodium chloride 9 mg/ml
11171897|NCT02006121|BG002|Baseline|Total|Total of all reporting groups
11171898|NCT02006121|FG000|Participant Flow|Apomorphine Hydrochloride|"Apo-go® Apomorphine hydrochloride 5 mg/ml solution in 10 mL pre-filled syringes for continuous infusion during the waking day using a Cane CRONO APO-Go® infusion pump. Hourly flow rate adjusted in increments of 0.5-1.0 mg/hour/day during titration to reach the patient's individualized required dose in a range of 3-8 mg/hour for 14-18 hours per day.~Concomitant medications were reduced/discontinued in the following order: dopamine agonists, MAO-B inhibitors, COMT inhibitors, levodopa dose then frequency."
11171899|NCT02006121|FG001|Participant Flow|Placebo|"Blinded Placebo: saline infusion; Open Label, placebo switched to apomorphine infusion.~Blinded phase: Sodium chloride 9 mg/ml continuous infusion during the waking day using a Cane CRONO APO-Go® infusion pump. Hourly flow rate adjusted in increments of 0.5-1.0 mg/hour/day during titration to reach the patient's individualized required dose in a range of 3-8 mg/hour for 14-18 hours per day.~Concomitant medications were reduced/discontinued in the following order: dopamine agonists, MAO-B inhibitors, COMT inhibitors, levodopa dose then frequency.~Open Label phase: as per apomorphine arm"
11171900|NCT02006121|OG000|Outcome|Apomorphine Hydrochloride|Apo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe
11171901|NCT02006121|OG001|Outcome|Placebo|Placebo: saline infusion Sodium chloride 9 mg/ml
11171902|NCT02006121|OG000|Outcome|Apomorphine Hydrochloride|"Apo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe~Apomorphine hydrochloride: Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe"
11171903|NCT02006121|OG001|Outcome|Placebo|"Placebo: saline infusion~Placebo: Sodium chloride 9 mg/ml"
11171904|NCT02006121|OG000|Outcome|Apomorphine Hydrochloride|"Apo-go® Apomorphine hydrochloride 5 mg/ml solution in 10 mL pre-filled syringes for continuous infusion during the waking day using a Cane CRONO APO-Go® infusion pump. Hourly flow rate adjusted in increments of 0.5-1.0 mg/hour/day during titration to reach the patient's individualized required dose in a range of 3-8 mg/hour for 14-18 hours per day.~Concomitant medications were reduced/discontinued in the following order: dopamine agonists, MAO-B inhibitors, COMT inhibitors, levodopa dose then frequency."
11171905|NCT02006121|OG001|Outcome|Placebo|"Blinded Placebo: saline infusion; Open Label, placebo switched to apomorphine infusion.~Blinded phase: Sodium chloride 9 mg/ml continuous infusion during the waking day using a Cane CRONO APO-Go® infusion pump. Hourly flow rate adjusted in increments of 0.5-1.0 mg/hour/day during titration to reach the patient's individualized required dose in a range of 3-8 mg/hour for 14-18 hours per day.~Concomitant medications were reduced/discontinued in the following order: dopamine agonists, MAO-B inhibitors, COMT inhibitors, levodopa dose then frequency.~Open Label phase: as per apomorphine arm"
11171906|NCT02006121|EG000|Reported Event|Apomorphine Hydrochloride|Apo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe
11171907|NCT02006121|EG001|Reported Event|Placebo|Placebo: saline infusion Sodium chloride 9 mg/ml
11171908|NCT02006160|BG000|Baseline|Treatment|"dalfampridine~dalfampridine: 10 mg bid"
11171909|NCT02006160|BG001|Baseline|Control|"placebo~placebo: 10 mg bid"
10901021|NCT01559935|OG000|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
10901022|NCT01559935|EG000|Reported Event|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
10901023|NCT01285362|BG000|Baseline|Fish Oil Supplementation (Group A)|"Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.~Fish Oil Supplementation: Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA."
10901024|NCT01285362|BG001|Baseline|Placebo Supplementation (Group B)|"Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.~Placebo Supplementation: Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules."
10901025|NCT01285362|BG002|Baseline|Total|Total of all reporting groups
10901026|NCT01285362|FG000|Participant Flow|Fish Oil Supplementation (Group A)|"Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.~Fish Oil Supplementation: Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA."
10901027|NCT01285362|FG001|Participant Flow|Placebo Supplementation (Group B)|"Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.~Placebo Supplementation: Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules."
10901028|NCT01285362|OG000|Outcome|Fish Oil Supplementation (Group A)|"Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.~Fish Oil Supplementation: Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA."
10901029|NCT01285362|OG001|Outcome|Placebo Supplementation (Group B)|"Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.~Placebo Supplementation: Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules."
10901030|NCT01285362|EG000|Reported Event|Fish Oil Supplementation (Group A)|Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.
10901031|NCT01285362|EG001|Reported Event|Placebo Supplementation (Group B)|Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.
10901032|NCT01067144|BG000|Baseline|Control|Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
10901033|NCT01067144|BG001|Baseline|Gabapentin|1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
10901034|NCT01067144|BG002|Baseline|Total|Total of all reporting groups
10901035|NCT01067144|FG000|Participant Flow|Control|Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
10901036|NCT01067144|FG001|Participant Flow|Gabapentin|1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
10901037|NCT01067144|OG000|Outcome|Control|Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
10901038|NCT01067144|OG001|Outcome|Gabapentin|1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
10901039|NCT01067144|EG000|Reported Event|Control|Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
10901040|NCT01067144|EG001|Reported Event|Gabapentin|1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
10901041|NCT00600483|BG000|Baseline|Gentamicin Group|"Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy~gentamicin-collagen sponge dipped in saline: 100-cm2 sponge"
10901042|NCT00600483|BG001|Baseline|Control Group|Standard of care, ie, insertion of no gentamicin-collagen sponge.
10901043|NCT00600483|BG002|Baseline|Total|Total of all reporting groups
10901044|NCT00600483|FG000|Participant Flow|Gentamicin Group|"Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy~gentamicin-collagen sponge dipped in saline: 100-cm2 sponge"
10901045|NCT00600483|FG001|Participant Flow|Control Group|Standard of care, ie, insertion of no gentamicin-collagen sponge.
10901046|NCT00600483|OG000|Outcome|Gentamicin Group|"Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy~gentamicin-collagen sponge dipped in saline: 100-cm2 sponge"
10901047|NCT00600483|OG001|Outcome|Control Group|Standard of care, ie, insertion of no gentamicin-collagen sponge.
10901048|NCT00600483|EG000|Reported Event|Gentamicin Group|"Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy~gentamicin-collagen sponge dipped in saline: 100-cm2 sponge"
10901049|NCT00600483|EG001|Reported Event|Control Group|Standard of care, ie, insertion of no gentamicin-collagen sponge. Includes patients randomized to Gentamicin but where not treated in the Gentamicin group
10901050|NCT00568854|BG000|Baseline|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
10901051|NCT00568854|BG001|Baseline|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
10901052|NCT00568854|BG002|Baseline|Total|Total of all reporting groups
10901053|NCT00568854|FG000|Participant Flow|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
10901054|NCT00568854|FG001|Participant Flow|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
10901055|NCT00568854|OG000|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
10901056|NCT00568854|OG001|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
10901057|NCT00568854|EG000|Reported Event|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
10901058|NCT00568854|EG001|Reported Event|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
10901059|NCT00568958|BG000|Baseline|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
10901060|NCT00568958|BG001|Baseline|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
10901061|NCT00568958|BG002|Baseline|Total|Total of all reporting groups
10901062|NCT00568958|FG000|Participant Flow|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
10901063|NCT00568958|FG001|Participant Flow|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
11171910|NCT02006160|BG002|Baseline|Total|Total of all reporting groups
11171911|NCT02006160|FG000|Participant Flow|Treatment|"dalfampridine~dalfampridine: 10 mg bid"
11171912|NCT02006160|FG001|Participant Flow|Control|"placebo~placebo: 10 mg bid"
11171913|NCT02006160|OG000|Outcome|Treatment|"dalfampridine~dalfampridine: 10 mg bid"
10901064|NCT00568958|OG000|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
10901065|NCT00568958|OG001|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
10901066|NCT00568958|EG000|Reported Event|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
10901067|NCT00568958|EG001|Reported Event|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
10901068|NCT00569010|BG000|Baseline|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
10901069|NCT00569010|BG001|Baseline|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
10901070|NCT00569010|BG002|Baseline|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
10901071|NCT00569010|BG003|Baseline|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
10901072|NCT00569010|BG004|Baseline|Total|Total of all reporting groups
10901073|NCT00569010|FG000|Participant Flow|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
10901074|NCT00569010|FG001|Participant Flow|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
10901075|NCT00569010|FG002|Participant Flow|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
10901076|NCT00569010|FG003|Participant Flow|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
10901077|NCT00569010|OG000|Outcome|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
10901078|NCT00569010|OG001|Outcome|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
10901079|NCT00569010|OG002|Outcome|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
10901080|NCT00569010|OG003|Outcome|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
10901081|NCT00569010|EG000|Reported Event|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
10901082|NCT00569010|EG001|Reported Event|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
10901083|NCT00569010|EG002|Reported Event|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
10901084|NCT00569010|EG003|Reported Event|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
10901085|NCT00569166|BG000|Baseline|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901086|NCT00569166|BG001|Baseline|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901087|NCT00569166|BG002|Baseline|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901088|NCT00569166|BG003|Baseline|Total|Total of all reporting groups
10901089|NCT00569166|FG000|Participant Flow|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
11171914|NCT02006160|OG001|Outcome|Control|"placebo~placebo: 10 mg bid"
11171915|NCT02006160|EG000|Reported Event|Treatment|"dalfampridine~dalfampridine: 10 mg bid"
10901090|NCT00569166|FG001|Participant Flow|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901091|NCT00569166|FG002|Participant Flow|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901092|NCT00569166|OG000|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901093|NCT00569166|OG001|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901094|NCT00569166|OG002|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901095|NCT00569166|EG000|Reported Event|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901096|NCT00569166|EG001|Reported Event|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901097|NCT00569166|EG002|Reported Event|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
10901098|NCT00569192|BG000|Baseline|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
10901099|NCT00569192|BG001|Baseline|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
10901100|NCT00569192|BG002|Baseline|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
11171916|NCT02006160|EG001|Reported Event|Control|"placebo~placebo: 10 mg bid"
10901101|NCT00569192|BG003|Baseline|Total|Total of all reporting groups
10901102|NCT00569192|FG000|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
10901103|NCT00569192|FG001|Participant Flow|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
10901104|NCT00569192|FG002|Participant Flow|0.25 mg MAP0010|0.125mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
10901105|NCT00569192|OG000|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
10901106|NCT00569192|OG001|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
10901107|NCT00569192|OG002|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
10901108|NCT00569192|EG000|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
10901109|NCT00569192|EG001|Reported Event|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
10901110|NCT00569192|EG002|Reported Event|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
10901111|NCT00569231|BG000|Baseline|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
10901112|NCT00569231|FG000|Participant Flow|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
10901113|NCT00569231|OG000|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
10901114|NCT00569231|EG000|Reported Event|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
10901115|NCT00569270|BG000|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Tiotropium first.
10901116|NCT00569270|FG000|Participant Flow|Tiotropium 18 µg Capsule First, Then Placebo|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
10901117|NCT00569270|FG001|Participant Flow|Placebo First, Then Tiotropium Bromide 18 µg|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
10901118|NCT00569270|OG000|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
10901119|NCT00569270|OG001|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
10901120|NCT00569270|OG000|Outcome|Lung CT Scored Emphysema and FEV1|Extent of lung CT scored emphysema and and lung function of FEV1(l) after tiotropium
10901121|NCT00569270|OG001|Outcome|Tiotropium 18 µg Capsule, Bronchodilator|Includes groups randomized to receive placebo first and Tiotropium first.
10901122|NCT00569270|OG000|Outcome|Lung CT Scored Emphysema and IC|Extent of lung CT scored emphysema (percent of lung) and lung function of IC (inspiratory capacity, L) after tiotropium.
11171917|NCT02006264|BG000|Baseline|TDF Intravaginal Ring|TDF Intravaginal Ring (TDF IVR)
11171918|NCT02006264|BG001|Baseline|Placebo Intravaginal Ring|Placebo Intravaginal Ring (Placebo IVR)
11171919|NCT02006264|BG002|Baseline|Total|Total of all reporting groups
11171920|NCT02006264|FG000|Participant Flow|TDF Intravaginal Ring|"TDF Intravaginal Ring (TDF-IVR)~The TDF (tenofovir disoproxil fumarate) IVR (intravaginal ring) has an inner core compartment comprised of 86% w/w (weight by weight) TDF and 14% w/w sodium chloride (NaCl). The TDF intravaginal ring will be worn continuously for 14 days. It will be inserted into the vagina following cessation of participant's menses at Visit 3 and removed at Visit 7."
10901123|NCT00569270|OG001|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first
10901124|NCT00569270|OG000|Outcome|Before DH (Dynamic Hyperinflation)|IC (inspiratory capacity) before and after metronome paced hyperventilation and induced dynamic hyperinflation at baseline;
10901125|NCT00569270|OG001|Outcome|After DH (Dynamic Hyperinflation|IC (inspiratory capacity) before and after metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
10901126|NCT00569270|OG000|Outcome|2h Post Placebo TLC(L)|total lung capacity (L) following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
10901127|NCT00569270|OG001|Outcome|TLC (L) 2h Post Tiotropium|Total Lung Capacity (L)following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h tiotropium
10901128|NCT00569270|OG000|Outcome|Lung CT Scored Emphysema and FRC/TLC|Extent of lung CT scored emphysema (percent of lung) and lung function of FRC/TLC (functional residual capacity(L)/total lung capacity (L) after tiotropium
10901129|NCT00569270|EG000|Reported Event|Tiotropium Bromide 18 µg, Capsule,|tiotropium 18 µg capsule for 1 month. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium. (30 enrolled subjects, one drop-out)
10901130|NCT00569270|EG001|Reported Event|Placebo|Adverse events after placebo. (30 enrolled subjects, one drop-out)
11171921|NCT02006264|FG001|Participant Flow|Placebo Intravaginal Ring|"Placebo Intravaginal Ring (Placebo IVR)~The placebo intravaginal ring (IVR) has an inner core which contains sodium chloride (NaCl). The intravaginal ring will be worn continuously for 14 days. It will be inserted into the vagina following cessation of participant's menses at Visit 3 and removed at Visit 7."
11171922|NCT02006264|OG000|Outcome|TDF Intravaginal Ring|TDF Intravaginal Ring (TDF IVR)
11171923|NCT02006264|OG001|Outcome|Placebo Intravaginal Ring|Placebo Intravaginal Ring (Placebo IVR)
11233360|NCT02426918|FG002|Participant Flow|Vancomycin/Linezolid BID|Vancomycin was administered intravenously BID at doses of 1 gram (g) or 15 milligrams per kilogram (mg/kg). After 2 doses of Vancomycin IV, Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.
10901131|NCT00569309|BG000|Baseline|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
10901132|NCT00569309|FG000|Participant Flow|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
11171924|NCT02006264|EG000|Reported Event|TDF Intravaginal Ring|TDF Intravaginal Ring (TDF IVR)
11171925|NCT02006264|EG001|Reported Event|Placebo Intravaginal Ring|Placebo Intravaginal Ring (Placebo IVR)
11171926|NCT02006342|BG000|Baseline|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
11171927|NCT02006342|BG001|Baseline|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
11171928|NCT02006342|BG002|Baseline|Total|Total of all reporting groups
11171929|NCT02006342|FG000|Participant Flow|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
11171930|NCT02006342|FG001|Participant Flow|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
11171931|NCT02006342|OG000|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
11171932|NCT02006342|OG001|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
11171933|NCT02006342|EG000|Reported Event|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
11171934|NCT02006342|EG001|Reported Event|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
10901133|NCT00569309|OG000|Outcome|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
10901134|NCT00569309|EG000|Reported Event|Prevnar|The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
10901135|NCT00569374|BG000|Baseline|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
10901136|NCT00569374|FG000|Participant Flow|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
10901137|NCT00569374|OG000|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
10901138|NCT00569374|EG000|Reported Event|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
10901139|NCT00569530|BG000|Baseline|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
11233361|NCT02426918|OG000|Outcome|Debio 1450 80 mg/120 mg BID|Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.
11233362|NCT02426918|OG001|Outcome|Debio 1450 160 mg/240 mg BID|Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.
10901140|NCT00569530|BG001|Baseline|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
10901141|NCT00569530|BG002|Baseline|Total|Total of all reporting groups
10901142|NCT00569530|FG000|Participant Flow|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
10901143|NCT00569530|FG001|Participant Flow|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
10901144|NCT00569530|OG000|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
10901145|NCT00569530|OG001|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
10901146|NCT00569530|EG000|Reported Event|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
10901147|NCT00569530|EG001|Reported Event|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
10901148|NCT00569582|BG000|Baseline|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
10901149|NCT00569582|FG000|Participant Flow|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
11233363|NCT02426918|OG002|Outcome|Vancomycin/Linezolid BID|Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.
10901150|NCT00569582|OG000|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
10901151|NCT00569582|EG000|Reported Event|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
10901152|NCT00569660|BG000|Baseline|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
10901153|NCT00569660|FG000|Participant Flow|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
10901154|NCT00569660|OG000|Outcome|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
10901155|NCT00569660|EG000|Reported Event|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
10901156|NCT00569673|BG000|Baseline|Docetaxel Plus Trabectedin|"Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELISµ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy."
10901157|NCT00569673|FG000|Participant Flow|Docetaxel Plus Trabectedin|"Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELISµ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy."
10901158|NCT00569673|OG000|Outcome|Docetaxel Plus Trabectedin|"Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELISµ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy."
10901159|NCT00569673|EG000|Reported Event|Docetaxel Plus Trabectedin|"Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELISµ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy."
10901160|NCT00569777|BG000|Baseline|K-lens|etafilcon A contact lens with ketotifen.
10901161|NCT00569777|BG001|Baseline|Placebo|etafilcon A contact lens without ketotifen
10901162|NCT00569777|BG002|Baseline|Total|Total of all reporting groups
10901163|NCT00569777|FG000|Participant Flow|K-lens|etafilcon A contact lens with ketotifen.
10901164|NCT00569777|FG001|Participant Flow|Placebo|etafilcon A contact lens without ketotifen
10901165|NCT00569777|OG000|Outcome|K-lens|etafilcon A contact lens with ketotifen.
10901166|NCT00569777|OG001|Outcome|Placebo|etafilcon A contact lens without ketotifen
10901167|NCT00569777|EG000|Reported Event|K-lens|etafilcon A contact lens with ketotifen.
10901168|NCT00569777|EG001|Reported Event|Placebo|etafilcon A contact lens without ketotifen
10901169|NCT00569803|BG000|Baseline|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
10901170|NCT00569803|BG001|Baseline|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
10901171|NCT00569803|BG002|Baseline|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
10901172|NCT00569803|BG003|Baseline|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901173|NCT00569803|BG004|Baseline|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901174|NCT00569803|BG005|Baseline|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901175|NCT00569803|BG006|Baseline|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
10901176|NCT00569803|BG007|Baseline|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
10901177|NCT00569803|BG008|Baseline|Total|Total of all reporting groups
10901178|NCT00569803|FG000|Participant Flow|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
10901179|NCT00569803|FG001|Participant Flow|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
10901180|NCT00569803|FG002|Participant Flow|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
10901181|NCT00569803|FG003|Participant Flow|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901182|NCT00569803|FG004|Participant Flow|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901183|NCT00569803|FG005|Participant Flow|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901184|NCT00569803|FG006|Participant Flow|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
10901185|NCT00569803|FG007|Participant Flow|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
10901186|NCT00569803|OG000|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
10901187|NCT00569803|OG001|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
10901188|NCT00569803|OG002|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
10901189|NCT00569803|OG003|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901190|NCT00569803|OG004|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901191|NCT00569803|OG005|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901192|NCT00569803|OG006|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
10901193|NCT00569803|OG000|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
10901194|NCT00569803|OG000|Outcome|1 Injection Site|Participants receiving treatments of 50mg, 100mg and 125mg Subcutaneous Belatacept were injected at 1 site at the anterior thigh.
10901195|NCT00569803|OG001|Outcome|2 Injection Sites|Participants receiving treatments of 150mg, 200mg and 250mg Subcutaneous Belatacept were injected at 2 sites; one injection equal to half the total dose was delivered to the anterior thigh on each side.
10901196|NCT00569803|OG007|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
10901197|NCT00569803|EG000|Reported Event|Belatacept 50mg SC|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
10901198|NCT00569803|EG001|Reported Event|Belatacept 100mg SC|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
10901199|NCT00569803|EG002|Reported Event|Belatacept 125mg SC|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
10901200|NCT00569803|EG003|Reported Event|Belatacept 150mg SC|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901201|NCT00569803|EG004|Reported Event|Belatacept 200mg SC|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901202|NCT00569803|EG005|Reported Event|Belatacept 250mg SC|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
10901203|NCT00569803|EG006|Reported Event|Belatacept 125mg IV|125 mg Belatacept intravenous (IV) injection
10901204|NCT00569803|EG007|Reported Event|PLACEBO|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
10901205|NCT00569803|EG008|Reported Event|All Belatacept|All participants treated with IV or SC Belatacept of any dose
11233364|NCT02426918|EG000|Reported Event|Debio 1450 80 mg/120 mg BID|Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.
10901206|NCT00569855|BG000|Baseline|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
10901207|NCT00569855|FG000|Participant Flow|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
10901208|NCT00569855|OG000|Outcome|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
10901209|NCT00569855|EG000|Reported Event|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
10901210|NCT00569946|BG000|Baseline|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
10901211|NCT00569946|FG000|Participant Flow|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
10901212|NCT00569946|OG000|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
10901213|NCT00569946|EG000|Reported Event|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
10901214|NCT00570037|BG000|Baseline|Hospital With Immunization Program|
10901215|NCT00570037|BG001|Baseline|Hospital With No Immunization Program|
10901216|NCT00570037|BG002|Baseline|Total|Total of all reporting groups
10901217|NCT00570037|FG000|Participant Flow|Hospital With Immunization Program|
10901218|NCT00570037|FG001|Participant Flow|Hospital With No Immunization Program|
10901219|NCT00570037|OG000|Outcome|Hospital With Immunization Program|
10901220|NCT00570037|OG001|Outcome|Hospital With No Immunization Program|
10901221|NCT00570037|EG000|Reported Event|Hospital With Immunization Program|
10901222|NCT00570037|EG001|Reported Event|Hospital With No Immunization Program|
10901223|NCT00570063|BG000|Baseline|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
10901224|NCT00570063|BG001|Baseline|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
10901225|NCT00570063|BG002|Baseline|Total|Total of all reporting groups
11233365|NCT02426918|EG001|Reported Event|Debio 1450 160 mg/240 mg BID|Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.
11233366|NCT02426918|EG002|Reported Event|Vancomycin/Linezolid BID|Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.
11233367|NCT02427100|BG000|Baseline|Control Group|Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.
10901226|NCT00570063|FG000|Participant Flow|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
10901227|NCT00570063|FG001|Participant Flow|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
10901228|NCT00570063|OG000|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
10901229|NCT00570063|OG001|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
10901230|NCT00570063|EG000|Reported Event|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
10901231|NCT00570063|EG001|Reported Event|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
10901232|NCT00570089|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Study drug Ranexa or Placebo.
10901233|NCT00570089|FG000|Participant Flow|Study Drug Ranexa Then Placebo|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
10901234|NCT00570089|FG001|Participant Flow|Placebo Then Study Drug Ranexa|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
10901235|NCT00570089|OG000|Outcome|Study Drug Ranexa - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
10901236|NCT00570089|OG001|Outcome|Placebo - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
10901237|NCT00570089|OG000|Outcome|Study Drug|Study drug Ranexa arm
10901238|NCT00570089|OG001|Outcome|Placebo|Placebo arm
10901239|NCT00570089|EG000|Reported Event|Study Drug|Study drug Ranexa arm
10901240|NCT00570089|EG001|Reported Event|Placebo|Placebo arm
10901241|NCT00570128|BG000|Baseline|Donepezil HCl|Blinded donepezil HCl 2.5 mg/day (2.5 mL/day) orally for participants with BW 20 and <25 kg, 5 mg/day (5 mL/day) orally for participants with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for participants with BW >=50 kg liquid formulation (1 mg/1 mL) (titrated to 0.1 to 0.2 mg/kg/day based on BW).
10901242|NCT00570128|BG001|Baseline|Placebo|Liquid formulation matched to active treatment for oral administration.
10901243|NCT00570128|BG002|Baseline|Total|Total of all reporting groups
10901244|NCT00570128|FG000|Participant Flow|Donepezil HCl|Blinded donepezil hydrochloride (HCl) 2.5 milligram per day (mg/day) (2.5 milliliter per day [mL/day]) orally for participants with body weight (BW) 20 and less than (<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for participants with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for participants with BW greater than or equal to (>=) 50 kg liquid formulation (1 milligram per 1 milliliter [1 mg/1 mL]) (titrated to 0.1 to 0.2 milligram per kilogram per day [mg/kg/day] based on BW).
11233368|NCT02427100|BG001|Baseline|Intervention Group|"Intervention participants will receive 4 weekly newsletters, a pedometer with walking advice, and twice daily fruit/vegetable snacks during weekdays.~Diet/Physical Activity: Diet/Physical Activity Intervention"
10901245|NCT00570128|FG001|Participant Flow|Placebo|Liquid formulation matched to active treatment for oral administration.
10901246|NCT00570128|OG000|Outcome|Donepezil HCl|Blinded donepezil HCl 2.5 mg/day (2.5 mL/day) orally for participants with BW 20 and <25 kg, 5 mg/day (5 mL/day) orally for participants with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for participants with BW >=50 kg liquid formulation (1 mg/1 mL) (titrated to 0.1 to 0.2 mg/kg/day based on BW).
10901247|NCT00570128|OG001|Outcome|Placebo|Liquid formulation matched to active treatment for oral administration.
10901248|NCT00570128|EG000|Reported Event|Donepezil HCl|Blinded donepezil HCl 2.5 mg/day (2.5 mL/day) orally for participants with BW 20 and <25 kg, 5 mg/day (5 mL/day) orally for participants with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for participants with BW >=50 kg liquid formulation (1 mg/1 mL) (titrated to 0.1 to 0.2 mg/kg/day based on BW).
10901249|NCT00570128|EG001|Reported Event|Placebo|Liquid formulation matched to active treatment for oral administration.
10901250|NCT00570141|BG000|Baseline|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
10901251|NCT00570141|FG000|Participant Flow|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
10901252|NCT00570141|OG000|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
10901253|NCT00570141|EG000|Reported Event|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
10901254|NCT00570232|BG000|Baseline|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
10901255|NCT00570232|FG000|Participant Flow|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
10901256|NCT00570232|OG000|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
10901257|NCT00570232|EG000|Reported Event|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
10901258|NCT00570310|BG000|Baseline|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
11233369|NCT02427100|BG002|Baseline|Total|Total of all reporting groups
11233370|NCT02427100|FG000|Participant Flow|Control Group|Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.
11233371|NCT02427100|FG001|Participant Flow|Intervention Group|"Intervention participants will receive 4 weekly newsletters, a pedometer with walking advice, and twice daily fruit/vegetable snacks during weekdays.~Diet/Physical Activity: Diet/Physical Activity Intervention"
11233372|NCT02427100|OG000|Outcome|Control Group|Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.
11233373|NCT02427100|OG001|Outcome|Intervention Group|"Intervention participants will receive 4 weekly newsletters, a pedometer with walking advice, and twice daily fruit/vegetable snacks during weekdays.~Diet/Physical Activity: Diet/Physical Activity Intervention"
11233374|NCT02427100|EG000|Reported Event|Control Group|Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.
11233375|NCT02427100|EG001|Reported Event|Intervention Group|"Intervention participants will receive 4 weekly newsletters, a pedometer with walking advice, and twice daily fruit/vegetable snacks during weekdays.~Diet/Physical Activity: Diet/Physical Activity Intervention"
11233376|NCT02427399|BG000|Baseline|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
11233377|NCT02427399|BG001|Baseline|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient's primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
11233378|NCT02427399|BG002|Baseline|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider's email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
10901259|NCT00570310|BG001|Baseline|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
11233379|NCT02427399|BG003|Baseline|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
11233380|NCT02427399|BG004|Baseline|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
11233381|NCT02427399|BG005|Baseline|Total|Total of all reporting groups
11233382|NCT02427399|FG000|Participant Flow|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
11233383|NCT02427399|FG001|Participant Flow|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient's primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
10901260|NCT00570310|BG002|Baseline|Total|Total of all reporting groups
10901261|NCT00570310|FG000|Participant Flow|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
10901262|NCT00570310|FG001|Participant Flow|Placebo|Patients were treated with placebo starting at randomization.
10901263|NCT00570310|OG000|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
10901264|NCT00570310|OG001|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
10901265|NCT00570310|EG000|Reported Event|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
10901266|NCT00570310|EG001|Reported Event|Placebo|Patients were treated with placebo starting at randomization.
10901267|NCT00570323|BG000|Baseline|Arimidex With Faslodex|"Arimidex with Faslodex in postmenopausal women~Arimidex with Faslodex: Arimidex with Faslodex"
10901268|NCT00570323|BG001|Baseline|Arimidex|"Arimidex without Faslodex in postmenopausal women.~Arimidex without Faslodex: Arimidex without Faslodex"
10901269|NCT00570323|BG002|Baseline|Total|Total of all reporting groups
10901270|NCT00570323|FG000|Participant Flow|Arimidex With Faslodex|"Arimidex with Faslodex in postmenopausal women~Arimidex with Faslodex: Arimidex with Faslodex"
10901271|NCT00570323|FG001|Participant Flow|Arimidex|"Arimidex without Faslodex in postmenopausal women.~Arimidex without Faslodex: Arimidex without Faslodex"
10901272|NCT00570323|OG000|Outcome|ARM A / Arimidex With Faslodex|"Arimidex with Faslodex in postmenopausal women~Arimidex: Aromatase inhibitors~Faslodex: Hormone Receptor"
11233384|NCT02427399|FG002|Participant Flow|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider's email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
10901273|NCT00570323|OG001|Outcome|ARM B Arimidex Without Faslodex|"Arimidex without Faslodex in postmenopausal women.~Arimidex: Aromatase inhibitors"
10901274|NCT00570323|OG000|Outcome|Arimidex With Faslodex|"Arimidex with Faslodex in postmenopausal women~Arimidex with Faslodex: Arimidex with Faslodex"
10901275|NCT00570323|OG001|Outcome|Arimidex|"Arimidex without Faslodex in postmenopausal women.~Arimidex without Faslodex: Arimidex without Faslodex"
10901276|NCT00570323|EG000|Reported Event|Arimidex|"Arimidex without Faslodex in postmenopausal women.~Arimidex without Faslodex: Arimidex without Faslodex"
10901277|NCT00570323|EG001|Reported Event|Arimidex With Faslodex|"Arimidex with Faslodex in postmenopausal women~Arimidex with Faslodex: Arimidex with Faslodex"
10901278|NCT00570349|BG000|Baseline|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
10901279|NCT00570349|BG001|Baseline|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
10901280|NCT00570349|BG002|Baseline|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
10901281|NCT00570349|BG003|Baseline|Total|Total of all reporting groups
10901282|NCT00570349|FG000|Participant Flow|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
10901283|NCT00570349|FG001|Participant Flow|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
10901284|NCT00570349|FG002|Participant Flow|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
10901285|NCT00570349|OG000|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
10901286|NCT00570349|OG001|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
10901287|NCT00570349|OG002|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
10901288|NCT00570349|EG000|Reported Event|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
10901289|NCT00570349|EG001|Reported Event|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
10901290|NCT00570349|EG002|Reported Event|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
10901291|NCT00570362|BG000|Baseline|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
10901292|NCT00570362|BG001|Baseline|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
10901293|NCT00570362|BG002|Baseline|Total|Total of all reporting groups
10901294|NCT00570362|FG000|Participant Flow|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
10901295|NCT00570362|FG001|Participant Flow|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
10901296|NCT00570362|OG000|Outcome|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
10901297|NCT00570362|OG001|Outcome|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
10901298|NCT00570362|EG000|Reported Event|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
10901299|NCT00570362|EG001|Reported Event|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
10901300|NCT00570401|BG000|Baseline|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
10901301|NCT00570401|FG000|Participant Flow|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
10901302|NCT00570401|OG000|Outcome|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
10901303|NCT00570401|EG000|Reported Event|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
10901304|NCT00570492|BG000|Baseline|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
10901305|NCT00570492|BG001|Baseline|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
10901306|NCT00570492|BG002|Baseline|Total|Total of all reporting groups
11335634|NCT03554018|BG001|Baseline|Placebo|"Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.~Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)~Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours"
10901307|NCT00570492|FG000|Participant Flow|Placebo: Baseline Period|Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
10901308|NCT00570492|FG001|Participant Flow|Placebo: Double-blind Treatment Period|Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
10901309|NCT00570492|FG002|Participant Flow|FFNS 110 mcg: Double-blind Treatment Period|Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
10901310|NCT00570492|OG000|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
10901311|NCT00570492|OG001|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
10901312|NCT00570492|EG000|Reported Event|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
10901313|NCT00570492|EG001|Reported Event|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
10901314|NCT00570505|BG000|Baseline|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
10901315|NCT00570505|FG000|Participant Flow|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
10901316|NCT00570505|OG000|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
10901317|NCT00570505|EG000|Reported Event|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
10915196|NCT00634543|FG001|Participant Flow|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
10901318|NCT00570661|BG000|Baseline|ITF2357|"ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength (dose strengths of 7.5, 10, 12.5, 15, 20 mg and 50 mg).~Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity~ITF2357: ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours."
10901319|NCT00570661|FG000|Participant Flow|ITF2357|"ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength (dose strengths of 7.5, 10, 12.5, 15, 20 mg and 50 mg).~Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity~ITF2357: ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours."
10901320|NCT00570661|OG000|Outcome|ITF2357 - PP Population|All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
10901321|NCT00570661|OG001|Outcome|ITF2357 - ITT Population|The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
10901322|NCT00570661|EG000|Reported Event|IT2357 - Safety Population|Safety population: all recruited patients who received at least one dose of the study medication.
10901323|NCT00570674|BG000|Baseline|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901324|NCT00570674|FG000|Participant Flow|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
11233385|NCT02427399|FG003|Participant Flow|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
10901325|NCT00570674|FG001|Participant Flow|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901326|NCT00570674|FG002|Participant Flow|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901327|NCT00570674|FG003|Participant Flow|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901328|NCT00570674|FG004|Participant Flow|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901329|NCT00570674|FG005|Participant Flow|Phase I Dose Level 4 Expansion Cohort: AC-RT|"Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.~If no DLTs are observed at dose level 4 then ten additional participants (expansion cohort) will be enrolled at that dose level."
10901330|NCT00570674|FG006|Participant Flow|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901331|NCT00570674|OG000|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901332|NCT00570674|OG000|Outcome|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901333|NCT00570674|OG001|Outcome|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901334|NCT00570674|OG002|Outcome|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901335|NCT00570674|OG003|Outcome|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901336|NCT00570674|OG004|Outcome|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901337|NCT00570674|OG000|Outcome|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901338|NCT00570674|OG000|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901339|NCT00570674|EG000|Reported Event|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
10901340|NCT00570687|BG000|Baseline|Amendment 1|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
10901341|NCT00570687|BG001|Baseline|Original Protocol|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
10901342|NCT00570687|BG002|Baseline|Total|Total of all reporting groups
10901343|NCT00570687|FG000|Participant Flow|Amendment 1: TI 60 U Then Insulin Lispro 10 U|60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
10901344|NCT00570687|FG001|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 60 U TI|10 U subcutaneously administered insulin lispro, followed by 60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
10901345|NCT00570687|FG002|Participant Flow|Amendment 1: TI 90 U Then 10 U Insulin Lispro|90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
10901346|NCT00570687|FG003|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 90 U TI|10 U subcutaneously administered insulin lispro, followed by 90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
10901347|NCT00570687|FG004|Participant Flow|Original Protocol: TI to Insulin Lispro to Exubera|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 12 U of subcutaneously administered insulin lispro, and then 4 mg of Exubera administered via inhalation
10901348|NCT00570687|FG005|Participant Flow|Original Protocol: TI to Exubera to Insulin Lispro|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 4 mg of Exubera administered via inhalation, and then 12 U of subcutaneously administered insulin lispro
10901349|NCT00570687|FG006|Participant Flow|Original Protocol: Exubera to Insulin Lispro to TI|4 mg of Exubera administered via inhalation, followed by 12 U of subcutaneously administered insulin lispro,and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
11233386|NCT02427399|FG004|Participant Flow|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
10901350|NCT00570687|FG007|Participant Flow|Original Protocol: Exubera to TI to Insulin Lispro|4 mg of Exubera administered via inhalation, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler,. and then 12 U of subcutaneously administered insulin lispro
10901351|NCT00570687|FG008|Participant Flow|Original Protocol: Insulin Lispro to TI to Exubera|12 U of subcutaneously administered insulin lispro, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, and then 4 mg of Exubera administered via inhalation
11335635|NCT03554018|BG002|Baseline|Total|Total of all reporting groups
10901352|NCT00570687|FG009|Participant Flow|Original Protocol: Insulin Lispro to Exubera to TI|12 U of subcutaneously administered insulin lispro, followed by 4 mg of Exubera administered via inhalation, and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
10901353|NCT00570687|OG000|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
10901354|NCT00570687|OG001|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
10901355|NCT00570687|OG002|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
10901356|NCT00570687|OG003|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
10901357|NCT00570687|OG004|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
10901358|NCT00570687|OG005|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
10901359|NCT00570687|EG000|Reported Event|Amendment 1 -TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
10901360|NCT00570687|EG001|Reported Event|Amendment 1 - TI Inhalation Powder 60 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
10901361|NCT00570687|EG002|Reported Event|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
10901362|NCT00570687|EG003|Reported Event|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
10901363|NCT00570687|EG004|Reported Event|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
10901364|NCT00570687|EG005|Reported Event|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
10901365|NCT00570700|BG000|Baseline|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
10901366|NCT00570700|FG000|Participant Flow|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
10901367|NCT00570700|OG000|Outcome|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
10901368|NCT00570700|EG000|Reported Event|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
10901369|NCT00570713|BG000|Baseline|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
10901370|NCT00570713|BG001|Baseline|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
10901371|NCT00570713|BG002|Baseline|Total|Total of all reporting groups
10901372|NCT00570713|FG000|Participant Flow|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
10901373|NCT00570713|FG001|Participant Flow|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
10901374|NCT00570713|OG000|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
10901375|NCT00570713|OG001|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
11171935|NCT02006420|BG000|Baseline|Scleroderma|"Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.~ARFI-SVI Ultrasound: Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes."
11171936|NCT02006420|BG001|Baseline|Control|"Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.~ARFI-SVI Ultrasound: Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes."
11171937|NCT02006420|BG002|Baseline|Total|Total of all reporting groups
11171938|NCT02006420|FG000|Participant Flow|Scleroderma|Scleroderma participants could have limited or diffuse scleroderma Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
10901376|NCT00570713|EG000|Reported Event|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
10901377|NCT00570713|EG001|Reported Event|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
10901378|NCT00570739|BG000|Baseline|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
10901379|NCT00570739|BG001|Baseline|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
10901380|NCT00570739|BG002|Baseline|Pre-diabetic Group: Placebo|This group received 6 colesevelam matching placebo tablets once per day for 16 weeks
10901381|NCT00570739|BG003|Baseline|Pre-diabetic Group: Colesevelam|This group received 6 colesevelam tablets, 625mg, once per day for 16 weeks.
10901382|NCT00570739|BG004|Baseline|Total|Total of all reporting groups
10901383|NCT00570739|FG000|Participant Flow|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
10901384|NCT00570739|FG001|Participant Flow|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
10901385|NCT00570739|FG002|Participant Flow|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
10901386|NCT00570739|FG003|Participant Flow|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
10901387|NCT00570739|OG000|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
10901388|NCT00570739|OG001|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
10901389|NCT00570739|OG000|Outcome|Type 2 Diabetes Group: Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
10901390|NCT00570739|OG000|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
10901391|NCT00570739|OG001|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
10901392|NCT00570739|OG000|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
10901393|NCT00570739|OG001|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
10901394|NCT00570739|OG001|Outcome|Type 2 Diabetes Group: Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
10901395|NCT00570739|OG000|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
10901396|NCT00570739|OG001|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
10901397|NCT00570739|OG002|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
10901398|NCT00570739|OG003|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
10901399|NCT00570739|OG000|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
10901400|NCT00570739|OG001|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
10901401|NCT00570739|OG002|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
10901402|NCT00570739|OG003|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
10901403|NCT00570739|OG000|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
10901404|NCT00570739|OG001|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
10901405|NCT00570739|OG002|Outcome|Type 2 Diabetes Group: Placebo + Metformin (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
10901406|NCT00570739|OG003|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
10901407|NCT00570739|OG000|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The total treatment duration was 16 weeks.
10901408|NCT00570739|OG001|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg once daily. The total treatment duration was 16 weeks.
10901409|NCT00570739|OG002|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
10901410|NCT00570739|OG003|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
10901411|NCT00570739|EG000|Reported Event|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
10901412|NCT00570739|EG001|Reported Event|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
10901413|NCT00570739|EG002|Reported Event|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
10901414|NCT00570739|EG003|Reported Event|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
10914919|NCT00633243|EG000|Reported Event|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
10914920|NCT00633243|EG001|Reported Event|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
10914921|NCT00633256|BG000|Baseline|Cycloserine|50 mg cycloserine
10914922|NCT00633256|BG001|Baseline|Placebo|Matched placebo
10914923|NCT00633256|BG002|Baseline|Total|Total of all reporting groups
10914924|NCT00633256|FG000|Participant Flow|Cycloserine|50 mg cycloserine
10914925|NCT00633256|FG001|Participant Flow|Placebo|Matched placebo
10914926|NCT00633256|OG000|Outcome|Cycloserine|50 mg cycloserine
10914927|NCT00633256|OG001|Outcome|Placebo|Matched placebo
10914928|NCT00633256|EG000|Reported Event|Cycloserine|50 mg cycloserine
10914929|NCT00633256|EG001|Reported Event|Placebo|Matched placebo
10914930|NCT00633360|BG000|Baseline|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
10914931|NCT00633360|BG001|Baseline|Placebo|"Placebo~Placebo: Once daily by mouth"
10914932|NCT00633360|BG002|Baseline|Total|Total of all reporting groups
10914933|NCT00633360|FG000|Participant Flow|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
10914934|NCT00633360|FG001|Participant Flow|Placebo|"Placebo~Placebo: Once daily by mouth"
10914935|NCT00633360|OG000|Outcome|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
10914936|NCT00633360|OG001|Outcome|Placebo|"Placebo~Placebo: Once daily by mouth"
10914937|NCT00633360|OG000|Outcome|Drospirenone and Ethinyl Estradiol|Drospirenone and ethinyl estradiol
10914938|NCT00633360|OG001|Outcome|Placebo|Placebo
10914939|NCT00633360|EG000|Reported Event|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
10914940|NCT00633360|EG001|Reported Event|Placebo|"Placebo~Placebo: Once daily by mouth"
10914941|NCT00633399|BG000|Baseline|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
10914942|NCT00633399|BG001|Baseline|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
10914943|NCT00633399|BG002|Baseline|Total|Total of all reporting groups
10914944|NCT00633399|FG000|Participant Flow|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
11171939|NCT02006420|FG001|Participant Flow|Control|Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
11171940|NCT02006420|OG000|Outcome|Scleroderma|Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
11171941|NCT02006420|OG001|Outcome|Control|Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
11171942|NCT02006420|OG000|Outcome|Scleroderma|Scleroderma Arm. Patients could have limited or diffuse scleroderma.Participants undergo durometer scoring on the forearm and thigh as part of the study.
11171943|NCT02006420|OG001|Outcome|Control Arm|Healthy volunteers who do not have scleroderma.Participants undergo durometer scoring on the forearm and thigh as part of the study.
11171944|NCT02006420|OG000|Outcome|All Participants|Scleroderma and Healthy Volunteers
11171945|NCT02006420|OG000|Outcome|Stiffness vs. Landmark|Scleroderma and Healthy Volunteers
11171946|NCT02006420|OG000|Outcome|Scleroderma Participants|Scleroderma Participants only
11171947|NCT02006420|OG000|Outcome|Stiffness vs. MRSS|Scleroderma Participants only
11171948|NCT02006420|EG000|Reported Event|Scleroderma|Scleroderma participants could have limited or diffuse scleroderma Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
11171949|NCT02006420|EG001|Reported Event|Control|Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
11171950|NCT02006472|BG000|Baseline|Placebo|"Pridopidine matching placebo (hard capsules)~Patients received a starting dose of placebo matching pridopidine 22.5 mg or matching placebo and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171951|NCT02006472|BG001|Baseline|Pridopidine 45 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171952|NCT02006472|BG002|Baseline|Pridopidine 67.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171953|NCT02006472|BG003|Baseline|Pridopidine 90 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171954|NCT02006472|BG004|Baseline|Pridopidine 112.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171955|NCT02006472|BG005|Baseline|Total|Total of all reporting groups
11171956|NCT02006472|FG000|Participant Flow|Placebo|"Pridopidine matching placebo (hard capsules)~Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to the randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171957|NCT02006472|FG001|Participant Flow|Pridopidine 45 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171958|NCT02006472|FG002|Participant Flow|Pridopidine 67.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171959|NCT02006472|FG003|Participant Flow|Pridopidine 90 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171960|NCT02006472|FG004|Participant Flow|Pridopidine 112.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171961|NCT02006472|OG000|Outcome|Placebo|"Pridopidine matching placebo (hard capsules)~Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171962|NCT02006472|OG001|Outcome|Pridopidine 45 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171963|NCT02006472|OG002|Outcome|Pridopidine 67.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11090843|NCT01531803|BG000|Baseline|Kedbumin 25%|"Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g/L human albumin, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin). The duration of treatment is based on the subject's response to treatment until hemodynamic stability is achieved. If hemodynamic stability is not achieved within 72 hours of starting the study treatment, the subject will be withdrawn from the study and will be treated according to standard practice and data collected during the study period will be used for the safety evaluation.~Kedbumin 25%: Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin)."
11090844|NCT01531803|BG001|Baseline|Normal Saline Solution|"Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.~Normal Saline Solution: Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment."
11090845|NCT01531803|BG002|Baseline|Total|Total of all reporting groups
11090846|NCT01531803|FG000|Participant Flow|Kedbumin 25%|"Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g/L human albumin, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin). The duration of treatment is based on the subject's response to treatment until hemodynamic stability is achieved. If hemodynamic stability is not achieved within 72 hours of starting the study treatment, the subject will be withdrawn from the study and will be treated according to standard practice and data collected during the study period will be used for the safety evaluation.~Kedbumin 25%: Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin)."
11090847|NCT01531803|FG001|Participant Flow|Normal Saline Solution|"Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.~Normal Saline Solution: Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment."
11090848|NCT01531803|OG000|Outcome|Kedbumin 25%|"Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g/L human albumin, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin). The duration of treatment is based on the subject's response to treatment until hemodynamic stability is achieved. If hemodynamic stability is not achieved within 72 hours of starting the study treatment, the subject will be withdrawn from the study and will be treated according to standard practice and data collected during the study period will be used for the safety evaluation.~Kedbumin 25%: Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin)."
10901415|NCT00570765|BG000|Baseline|DB OCA 10 mg|OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901416|NCT00570765|BG001|Baseline|DB OCA 50 mg|OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901417|NCT00570765|BG002|Baseline|DB OCA Placebo|Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901418|NCT00570765|BG003|Baseline|Total|Total of all reporting groups
10901419|NCT00570765|FG000|Participant Flow|DB OCA 10 mg|OCA 10 mg for 3 months during the DB phase.
10901420|NCT00570765|FG001|Participant Flow|DB OCA 50 mg|OCA 50 mg for 3 months during the DB phase.
10901421|NCT00570765|FG002|Participant Flow|DB OCA Placebo|Matching placebo for 3 months during the DB phase.
11090849|NCT01531803|OG001|Outcome|Normal Saline Solution|"Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.~Normal Saline Solution: Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment."
11090850|NCT01531803|EG000|Reported Event|Kedbumin 25%|"Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g/L human albumin, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin). The duration of treatment is based on the subject's response to treatment until hemodynamic stability is achieved. If hemodynamic stability is not achieved within 72 hours of starting the study treatment, the subject will be withdrawn from the study and will be treated according to standard practice and data collected during the study period will be used for the safety evaluation.~Kedbumin 25%: Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin)."
11090851|NCT01531803|EG001|Reported Event|Normal Saline Solution|"Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.~Normal Saline Solution: Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment."
11090852|NCT01531894|BG000|Baseline|GSK2110183 (Afuresertib)|All patients received the GSK2110183 (afuresertib) treatment
11090853|NCT01531894|FG000|Participant Flow|GSK2110183 (Afuresertib)|All patients received the GSK2110183 (afuresertib) treatment
11090854|NCT01531894|OG000|Outcome|GSK2110183 (Afuresertib)|All patients received the GSK2110183 (afuresertib) treatment
11090855|NCT01531894|EG000|Reported Event|All Patients|All patients received the GSK2110183 (afuresertib) treatment
10901422|NCT00570765|FG003|Participant Flow|LTSE OCA Total|After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901423|NCT00570765|OG000|Outcome|DB OCA 10 mg|OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901424|NCT00570765|OG001|Outcome|DB OCA 50 mg|OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901425|NCT00570765|OG002|Outcome|DB OCA Placebo|Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901426|NCT00570765|OG000|Outcome|LTSE OCA Total|After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901427|NCT00570765|OG000|Outcome|LTSE OCA Total|After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA (PO QD). Doses up to 50 mg daily were evaluated.
10901428|NCT00570765|EG000|Reported Event|DB OCA 10 mg|OCA 10 mg for 3 months during the DB phase.
10901429|NCT00570765|EG001|Reported Event|DB OCA 50 mg|OCA 50 mg for 3 months during the DB phase.
11171964|NCT02006472|OG003|Outcome|Pridopidine 90 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171965|NCT02006472|OG004|Outcome|Pridopidine 112.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52."
10901430|NCT00570765|EG002|Reported Event|DB OCA Placebo|Matching placebo for 3 months during the DB phase.
10901431|NCT00570765|EG003|Reported Event|LTSE OCA Total|After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
10901432|NCT00570778|BG000|Baseline|Overall Population|Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.
10901433|NCT00570778|FG000|Participant Flow|A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg|"Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.~Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days."
10901434|NCT00570778|FG001|Participant Flow|B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg|"Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days."
10901435|NCT00570778|FG002|Participant Flow|C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo|"Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days."
10901436|NCT00570778|FG003|Participant Flow|D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg|"Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days."
10901437|NCT00570778|OG000|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
10901438|NCT00570778|OG001|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
10901439|NCT00570778|OG002|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
10901440|NCT00570778|OG003|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
10901441|NCT00570778|EG000|Reported Event|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
10901442|NCT00570778|EG001|Reported Event|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
10901443|NCT00570778|EG002|Reported Event|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
10901444|NCT00570778|EG003|Reported Event|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
10901445|NCT00570908|BG000|Baseline|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
10901446|NCT00570908|FG000|Participant Flow|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
10901447|NCT00570908|OG000|Outcome|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
10901448|NCT00570908|EG000|Reported Event|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
10901449|NCT00570921|BG000|Baseline|Fulvestrant & Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.~Everolimus: Everolimus tablets, two-5 mg tablets a day~Fulvestrant: intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter"
10901450|NCT00570921|FG000|Participant Flow|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
10901451|NCT00570921|OG000|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
10901452|NCT00570921|EG000|Reported Event|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
10901453|NCT00570960|BG000|Baseline|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
10901454|NCT00570960|BG001|Baseline|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
10901455|NCT00570960|BG002|Baseline|Total|Total of all reporting groups
10901456|NCT00570960|FG000|Participant Flow|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
10901457|NCT00570960|FG001|Participant Flow|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
10901458|NCT00570960|OG000|Outcome|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
10901459|NCT00570960|OG001|Outcome|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
10901460|NCT00570960|EG000|Reported Event|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
10901461|NCT00570960|EG001|Reported Event|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
10901462|NCT00571038|BG000|Baseline|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
10901463|NCT00571038|BG001|Baseline|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
10901464|NCT00571038|BG002|Baseline|Total|Total of all reporting groups
10901465|NCT00571038|FG000|Participant Flow|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
10901466|NCT00571038|FG001|Participant Flow|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
10901467|NCT00571038|OG000|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
11090856|NCT01531959|BG000|Baseline|Midodrine|Midodrine: Patients will be randomized to blinded to 20 mg of midodrine
11090857|NCT01531959|BG001|Baseline|Placebo|Placebo: Patients will be randomized to blinded placebo control
10901468|NCT00571038|OG001|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
10901469|NCT00571038|EG000|Reported Event|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
10901470|NCT00571038|EG001|Reported Event|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
10901471|NCT00571064|BG000|Baseline|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 milligram (mg) per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
10901472|NCT00571064|FG000|Participant Flow|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 milligrams (mg) per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
10901473|NCT00571064|OG000|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 milligram (mg) per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
10901474|NCT00571064|OG000|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
10901475|NCT00571064|EG000|Reported Event|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
10901476|NCT00571103|BG000|Baseline|Open Label|All subjects received the drug.
10901477|NCT00571103|FG000|Participant Flow|Open Label|All subjects received the drug.
10901478|NCT00571103|OG000|Outcome|Open Label|All subjects received the drug.
10901479|NCT00571103|EG000|Reported Event|Open Label|All subjects received the drug.
10901480|NCT00571259|BG000|Baseline|1: Heparin Lock|"Dialysis catheter locked with heparin 1,000 units/mL post-dialysis.~Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis"
10901481|NCT00571259|BG001|Baseline|2: Gentamicin Lock|"Dialysis catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% post-dialysis.~4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis"
10901482|NCT00571259|BG002|Baseline|Total|Total of all reporting groups
10901483|NCT00571259|FG000|Participant Flow|1: Heparin Lock|"Dialysis Catheter locked with heparin 1,000 units/mL.~Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis"
10901484|NCT00571259|FG001|Participant Flow|2: Gentamicin Lock|"Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4%.~4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis"
10901485|NCT00571259|OG000|Outcome|1: Heparin Lock|"Dialysis Catheter locked with heparin 1,000 units/mL in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.~Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis"
11090858|NCT01531959|BG002|Baseline|Total|Total of all reporting groups
11090859|NCT01531959|FG000|Participant Flow|Midodrine|Midodrine: Patients will be randomized to blinded to 20 mg of midodrine
11090860|NCT01531959|FG001|Participant Flow|Placebo|Placebo: Patients will be randomized to blinded placebo control
11090861|NCT01531959|OG000|Outcome|Midodrine|Midodrine: Patients will be randomized to blinded to 20 mg of midodrine
11090862|NCT01531959|OG001|Outcome|Placebo|Placebo: Patients will be randomized to blinded placebo control
11090863|NCT01531959|EG000|Reported Event|Midodrine|Midodrine: Patients will be randomized to blinded to 20 mg of midodrine
11090864|NCT01531959|EG001|Reported Event|Placebo|Placebo: Patients will be randomized to blinded placebo control
11090865|NCT01531998|BG000|Baseline|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
10901486|NCT00571259|OG001|Outcome|2: Gentamicin Lock|"Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.~4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis"
10901487|NCT00571259|OG000|Outcome|1: Heparin Lock|Dialysis Catheter locked with heparin 1,000 units/mL in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.
10901488|NCT00571259|OG001|Outcome|2: Gentamicin Lock|Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.
10901489|NCT00571259|EG000|Reported Event|1: Heparin Lock|"Dialysis Catheter locked with heparin 1,000 units/mL.~Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis"
10901490|NCT00571259|EG001|Reported Event|2: Gentamicin Lock|"Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4%.~4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis"
10901491|NCT00571324|BG000|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
10901492|NCT00571324|FG000|Participant Flow|Exendin-(9-39) First, the Vehicle|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. The following day, after another overnight fast, normal saline (control) vehicle infusion was administered intravenously (IV) over 6 hours. During both infusions, blood glucose levels were measured every 20 minutes.
10901493|NCT00571324|FG001|Participant Flow|Vehicle First, Then Exendin-(9-39)|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours. The following day, after another overnight fast, Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. During both infusions, blood glucose levels were measured every 20 minutes.
10901494|NCT00571324|OG000|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
10901495|NCT00571324|OG001|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
10901496|NCT00571324|EG000|Reported Event|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
10901497|NCT00571324|EG001|Reported Event|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
10901498|NCT00571428|BG000|Baseline|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
10901499|NCT00571428|BG001|Baseline|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
10901500|NCT00571428|BG002|Baseline|Total|Total of all reporting groups
10901501|NCT00571428|FG000|Participant Flow|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
10901502|NCT00571428|FG001|Participant Flow|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
10901503|NCT00571428|OG000|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
10901504|NCT00571428|OG001|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
10901505|NCT00571428|EG000|Reported Event|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
10901506|NCT00571428|EG001|Reported Event|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
10901507|NCT00571493|BG000|Baseline|Phase I/II|In Phase 1 of the study, bortezomib was administered in 4 dose cohorts: 0.8 mg/m², 1.0 mg/m², 1.3 mg/m² and 1.5 mg/m². Bortezomib was given on days -11, -8, -5, and -2. All study patients received BEAM conditioning: carmustine (BCNU) 300 mg/m² on day -5, etoposide 100 mg/m² twice daily on days -5, -4, -3, and -2, cytarabine 100 mg/m² twice daily on days -5, -4, -3, and -2, and melphalan 140 mg/m² on day -1 before infusion of autologous stem cells. The objective of phase 1 was to determine the maximum tolerated dose (MTD) of bortezomib in this setting. The MTD was defined by observing any nonhematologic transplantation-related toxicity higher than grade 2 on the Bearman scale occurring between day -11 and engraftment. After the MTD was defined, patients were enrolled in Phase II to obtain a preliminary estimate of overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) using this regimen.
10901508|NCT00571493|FG000|Participant Flow|Phase 1: Bortezomib-0.8 mg/m²|Bortezomib dose - 0.8 mg/m² will be added to standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) regimen followed by autologous hematopoietic stem cell transplantation (ASCT).
10901509|NCT00571493|FG001|Participant Flow|Phase 1: Bortezomib-1.0 mg/m²|Bortezomib dose - 1.0 mg/m² will be added to standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) regimen followed by autologous hematopoietic stem cell transplantation (ASCT).
10901510|NCT00571493|FG002|Participant Flow|Phase 1: Bortezomib-1.3 mg/m²|Bortezomib dose - 1.3 mg/m² will be added to standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) regimen followed by autologous hematopoietic stem cell transplantation (ASCT).
10901511|NCT00571493|FG003|Participant Flow|Phase 1: Bortezomib-1.5 mg/m²|Bortezomib dose - 1.5 mg/m² will be added to standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) regimen followed by autologous hematopoietic stem cell transplantation (ASCT).
10901512|NCT00571493|FG004|Participant Flow|Phase II: Bortezomib-1.5 mg/m²|Obtain a preliminary estimate of the overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with maximum tolerated dose regimen.
10901513|NCT00571493|FG005|Participant Flow|Phase II: Bortezomib-1.3 mg/m²|Obtain a preliminary estimate of the overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with maximum tolerated dose regimen.
10901514|NCT00571493|FG006|Participant Flow|Phase II:Bortezomib-1.0 mg/m²|Obtain a preliminary estimate of the overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with maximum tolerated dose regimen.
10901515|NCT00571493|OG000|Outcome|Phase I|Maximum Tolerated Dose (MTD) of Bortezomib
10901516|NCT00571493|OG001|Outcome|Phase II|Maximum Tolerated Dose (MTD) of Bortezomib
10901517|NCT00571493|OG000|Outcome|Phase II: Overall Response Rate|To obtain a preliminary estimate of overall response rate (ORR). The overall response rate will be estimated as the number of participants who achieve a complete response (CR) or partial response (PR) divided by the number of evaluable participants.
10901518|NCT00571493|OG000|Outcome|Phase II: Progression Free Survival and Overall Survival|To obtain a preliminary estimate of progression free survival (PFS), and overall survival (OS)
10901519|NCT00571493|EG000|Reported Event|Phase I: Intervention|In Phase I of the study, bortezomib will be administered in 4 dose cohorts: .8 mg/m2 , 1.0 mg/m2, 1.3 mg/m2, and1.5 mg/m2. Three patients will be accrued in each dose cohort with enrollment starting at dose cohort 1 (.8 mg/m2). Bortezomib will be given on days -11,-8, -5, and -2. All study patients will receive BEAM conditioning per our standard institution protocol: carmustine (BCNU) 300 mg/m2 on day -5,etoposide 100 mg/m2 twice daily on days -5, -4, -3, and -2, cyatabine100 mg/m2 twice daily on days -5, -4, -3, and -2, and melphalan 140 mg/m2 on day -1 before infusion of autologous stem cells. The objective of phase I is to determine the maximum tolerated dose (MTD) of bortezomib in this setting. After the MTD is defined, another 20 patients will be enrolled in the Phase II portion of this protocol to obtain a preliminary estimate of the response rate.
10901520|NCT00571493|EG001|Reported Event|Phase II: Survival|Patients enrolled to obtain a preliminary estimate of ORR, Progression-free survival, and overall survival (OS) using this regimen.
10901521|NCT00571519|BG000|Baseline|Placebo|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
10901522|NCT00571519|BG001|Baseline|Rivoglitazone 0.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
10901523|NCT00571519|BG002|Baseline|Rivoglitazone 1.0mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
10901524|NCT00571519|BG003|Baseline|Rivoglitazone 1.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
10901525|NCT00571519|BG004|Baseline|Pioglitazone 15 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
10901526|NCT00571519|BG005|Baseline|Pioglitazone 30 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
10901527|NCT00571519|BG006|Baseline|Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
10901528|NCT00571519|BG007|Baseline|Total|Total of all reporting groups
10901529|NCT00571519|FG000|Participant Flow|Placebo|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
10901530|NCT00571519|FG001|Participant Flow|Rivoglitazone 0.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
10901531|NCT00571519|FG002|Participant Flow|Rivoglitazone 1.0mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
10901532|NCT00571519|FG003|Participant Flow|Rivoglitazone 1.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
10901533|NCT00571519|FG004|Participant Flow|Pioglitazone 15 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
10901534|NCT00571519|FG005|Participant Flow|Pioglitazone 30 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
10901535|NCT00571519|FG006|Participant Flow|Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
10901536|NCT00571519|OG000|Outcome|Placebo|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
10901537|NCT00571519|OG001|Outcome|Rivoglitazone 0.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
10901538|NCT00571519|OG002|Outcome|Rivoglitazone 1.0mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
10901539|NCT00571519|OG003|Outcome|Rivoglitazone 1.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
10901540|NCT00571519|OG004|Outcome|Pioglitazone 15 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
10901541|NCT00571519|OG005|Outcome|Pioglitazone 30 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
10901542|NCT00571519|OG006|Outcome|Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
10901543|NCT00571519|EG000|Reported Event|Placebo|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
10901544|NCT00571519|EG001|Reported Event|Rivoglitazone 0.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
10901545|NCT00571519|EG002|Reported Event|Rivoglitazone 1.0mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
10901546|NCT00571519|EG003|Reported Event|Rivoglitazone 1.5mg|Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
10901547|NCT00571519|EG004|Reported Event|Pioglitazone 15 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
10901548|NCT00571519|EG005|Reported Event|Pioglitazone 30 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
10901549|NCT00571519|EG006|Reported Event|Pioglitazone 45 mg|Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
10901550|NCT00571649|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days (SAF population)
10901551|NCT00571649|BG001|Baseline|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days (SAF population)
10901552|NCT00571649|BG002|Baseline|Total|Total of all reporting groups
10901553|NCT00571649|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days during treatment period
10901554|NCT00571649|FG001|Participant Flow|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days during treatment period
10901555|NCT00571649|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
10901556|NCT00571649|OG001|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
10901557|NCT00571649|EG000|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
10901558|NCT00571649|EG001|Reported Event|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
10901559|NCT00571662|BG000|Baseline|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
10901560|NCT00571662|FG000|Participant Flow|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
10901561|NCT00571662|OG000|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
10901562|NCT00571662|OG000|Outcome|Study Baseline|
10901563|NCT00571662|OG001|Outcome|Day + 28 Post Transplant|
10901564|NCT00571662|EG000|Reported Event|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
10901565|NCT00571688|BG000|Baseline|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment~Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
10901566|NCT00571688|BG001|Baseline|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
10901567|NCT00571688|BG002|Baseline|Total|Total of all reporting groups
10901568|NCT00571688|FG000|Participant Flow|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment~Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg intramuscularly (IM) every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
10901569|NCT00571688|FG001|Participant Flow|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
10901570|NCT00571688|OG000|Outcome|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment~Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
10901571|NCT00571688|OG001|Outcome|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
10914945|NCT00633399|FG001|Participant Flow|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
10901572|NCT00571688|EG000|Reported Event|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment~Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
11171966|NCT02006472|OG000|Outcome|Placebo|"Pridopidine matching placebo (hard capsules)~Patients received a starting dose of pridopidine 22.5 mg or matching placebo and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 52."
10901573|NCT00571688|EG001|Reported Event|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
10901574|NCT00571701|BG000|Baseline|Celecoxib First, Then Placebo|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
10901575|NCT00571701|BG001|Baseline|Placebo First, Then Celecoxib|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
10901576|NCT00571701|BG002|Baseline|Total|Total of all reporting groups
10901577|NCT00571701|FG000|Participant Flow|Celecoxib First (12 Months), Then Placebo (12 Months)|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
10901578|NCT00571701|FG001|Participant Flow|Placebo First (12 Months), Then Celecoxib (12 Months)|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
10901579|NCT00571701|OG000|Outcome|Celecoxib First, Then Placebo|"Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
10901580|NCT00571701|OG001|Outcome|Placebo First, Then Celecoxib|"Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
10901581|NCT00571701|OG000|Outcome|Celecoxib First (12 Months), Then Placebo (12 Months)|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
10901582|NCT00571701|OG001|Outcome|Placebo First (12 Months), Then Celecoxib (12 Months)|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
11171967|NCT02006472|OG001|Outcome|Pridopidine 45 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 52."
10901583|NCT00571701|OG000|Outcome|Celecoxib First - Males|Males treated with celecoxib during the first treatment period
10901584|NCT00571701|OG001|Outcome|Placebo First- Males|Males treated with placebo during the first treatment period
10901585|NCT00571701|OG002|Outcome|Celecoxib First- Females|Females treated with celecoxib during the first treatment period
10901586|NCT00571701|OG003|Outcome|Placebo First- Females|Females treated with placebo during the first treatment period
10901587|NCT00571701|OG000|Outcome|Celecoxib First- Juvenile Onset|Juvenile-onset subjects treated with celecoxib during the first treatment period
10901588|NCT00571701|OG001|Outcome|Placebo First- Juvenile-onsent|Juvenile-onset subjects treated with placebo during first treatment period
10901589|NCT00571701|OG002|Outcome|Celecoxib First - Adult Onset|Adult-onset subjects treated with celecoxib during the first treatment period
10901590|NCT00571701|OG003|Outcome|Placebo First- Adult-onset|Adult-onset subjects treated with placebo during the first treatment
10901591|NCT00571701|OG000|Outcome|Celecoxib First - HPV 6|Subjects infected with HPV 6 treated with celecoxib during the first treatment period
10901592|NCT00571701|OG001|Outcome|Placebo First- HPV 6|Subjects infected with HPV 6 treated with placebo during first treatment period
10901593|NCT00571701|OG002|Outcome|Celecoxib First- HPV 11|Subjects infected with HPV 11 treated with celecoxib during the first treatment period
10901594|NCT00571701|OG003|Outcome|Placebo First- HPV 11|Subjects infected with HPV 11 treated with placebo during the first treatment period
10901595|NCT00571701|OG000|Outcome|Responders|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period relative to mean disease severity prior to treatment.
10901596|NCT00571701|OG001|Outcome|Non-responders|Subjects randomized to celecoxib first with response less than 50% at end of first treatment period relative to mean disease severity prior to treatment.
10901597|NCT00571701|OG000|Outcome|Celecoxib Responders-maintained|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period that maintained response at end of second treatment.
10901598|NCT00571701|OG001|Outcome|Celecoxib Responders- Not Maintained|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period whose papilloma growth rate worsened by more than 0.01 at end of second treatment period.
10901599|NCT00571701|EG000|Reported Event|Celecoxib|Patients who received celecoxib for 12 months during either time period
10901600|NCT00571701|EG001|Reported Event|Placebo|Patients who received placebo for 12 months during either time period
10901601|NCT00571948|BG000|Baseline|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
10901602|NCT00571948|BG001|Baseline|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
10901603|NCT00571948|BG002|Baseline|Total|Total of all reporting groups
10901604|NCT00571948|FG000|Participant Flow|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
10901605|NCT00571948|FG001|Participant Flow|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
10901606|NCT00571948|OG000|Outcome|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
10901607|NCT00571948|OG001|Outcome|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
10901608|NCT00571948|EG000|Reported Event|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
10901609|NCT00571948|EG001|Reported Event|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
10901610|NCT00571961|BG000|Baseline|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
10901611|NCT00571961|FG000|Participant Flow|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r once daily in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
10901612|NCT00571961|OG000|Outcome|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
10901613|NCT00571961|EG000|Reported Event|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
10901614|NCT00571974|BG000|Baseline|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
10901615|NCT00571974|BG001|Baseline|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
10901616|NCT00571974|BG002|Baseline|Total|Total of all reporting groups
11171968|NCT02006472|OG002|Outcome|Pridopidine 67.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 52."
10901617|NCT00571974|FG000|Participant Flow|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
10901618|NCT00571974|FG001|Participant Flow|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
10901619|NCT00571974|OG000|Outcome|Phase I|Participants in the Phase I part of the study.
10901620|NCT00571974|OG000|Outcome|Phase II|Subjects treated with the MTD.
10901621|NCT00571974|EG000|Reported Event|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
10901622|NCT00571974|EG001|Reported Event|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
10901623|NCT00571987|BG000|Baseline|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
10901624|NCT00571987|FG000|Participant Flow|Subjects Received RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
10901625|NCT00571987|OG000|Outcome|Margin Status|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
10901626|NCT00571987|OG000|Outcome|Recurrences at the Site|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
10901627|NCT00571987|EG000|Reported Event|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
10901628|NCT00572039|BG000|Baseline|Problem Solving Treatment|"Problem Solving Treatment (PST)~PST: PST will be delivered in subjects' homes over the course of 6 weeks."
10901629|NCT00572039|BG001|Baseline|Supportive Therapy|"Supportive Therapy (ST)~ST: ST will be delivered in subjects' homes over the course of 6 weeks."
10901630|NCT00572039|BG002|Baseline|Total|Total of all reporting groups
10901631|NCT00572039|FG000|Participant Flow|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
10901632|NCT00572039|FG001|Participant Flow|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST's problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST's purpose is to explore the impact of vision loss on their lives.
10901633|NCT00572039|OG000|Outcome|Problem Solving Treatment|"Problem Solving Treatment (PST)~PST: PST will be delivered in subjects' homes over the course of 6 weeks."
10901634|NCT00572039|OG001|Outcome|Supportive Therapy|"Supportive Therapy (ST)~ST: ST will be delivered in subjects' homes over the course of 6 weeks."
10901635|NCT00572039|OG000|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
10901636|NCT00572039|OG001|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST's problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST's purpose is to explore the impact of vision loss on their lives.
10901637|NCT00572039|EG000|Reported Event|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
10901638|NCT00572039|EG001|Reported Event|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST's problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST's purpose is to explore the impact of vision loss on their lives.
10901639|NCT00572117|BG000|Baseline|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
10914946|NCT00633399|OG000|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
10914947|NCT00633399|OG001|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
10901640|NCT00572117|BG001|Baseline|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
10901641|NCT00572117|BG002|Baseline|Total|Total of all reporting groups
10901642|NCT00572117|FG000|Participant Flow|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
10901643|NCT00572117|FG001|Participant Flow|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
10901644|NCT00572117|OG000|Outcome|Topiramate|Change in average number of drinks/heavy drinking day
10901645|NCT00572117|OG001|Outcome|Placebo (Inert Pill) Arm|Change in average number of drinks/heavy drinking day
10901646|NCT00572117|OG000|Outcome|Topiramate|Change in HAM-D score from baseline
10901647|NCT00572117|OG001|Outcome|Placebo (Inert Pill) Arm|Change in HAM-D score from baseline
10901648|NCT00572117|EG000|Reported Event|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
10901649|NCT00572117|EG001|Reported Event|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
10901650|NCT00572156|BG000|Baseline|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
10901651|NCT00572156|BG001|Baseline|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
10901652|NCT00572156|BG002|Baseline|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
10901653|NCT00572156|BG003|Baseline|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
10901654|NCT00572156|BG004|Baseline|Total|Total of all reporting groups
10901655|NCT00572156|FG000|Participant Flow|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): Recombinant Human Growth Hormone (rhGH) (Somatropin) 45µg/kg once daily injection
10901656|NCT00572156|FG001|Participant Flow|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) (Mecasermin) 50µg/kg once daily injections
10901657|NCT00572156|FG002|Participant Flow|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
10901658|NCT00572156|FG003|Participant Flow|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
10901659|NCT00572156|OG000|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
11171969|NCT02006472|OG003|Outcome|Pridopidine 90 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 52."
11171970|NCT02006472|OG004|Outcome|Pridopidine 112.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 52."
10901660|NCT00572156|OG001|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
10901661|NCT00572156|OG002|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
10901662|NCT00572156|OG003|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
10901663|NCT00572156|EG000|Reported Event|1. rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
10901664|NCT00572156|EG001|Reported Event|2. 45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
10901665|NCT00572156|EG002|Reported Event|3. 45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
10901666|NCT00572156|EG003|Reported Event|4. 45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
10901667|NCT00572195|BG000|Baseline|Evaluation Group (Stimulation ON)|"Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.~RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day."
10901668|NCT00572195|FG000|Participant Flow|Evaluation Group (Stimulation ON)|"Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.~RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day."
10901669|NCT00572195|OG000|Outcome|Evaluation Group (Stimulation ON)|"Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.~RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day."
10901670|NCT00572195|EG000|Reported Event|Evaluation Group (Stimulation ON)|"Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.~RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day."
10901671|NCT00572234|BG000|Baseline|Receiving Bupropion SR|"receiving bupropion SR~bupropion SR: 12 week course of bupropion SR 150 mg, BID"
10901672|NCT00572234|BG001|Baseline|Treatment as Usual|Not receiving bupropion
10901673|NCT00572234|BG002|Baseline|Total|Total of all reporting groups
10901674|NCT00572234|FG000|Participant Flow|Receiving Bupropion (Sustain Release) SR|"receiving bupropion SR~bupropion SR: 12 week course of bupropion SR 150 mg, (twice a day) BID"
10901675|NCT00572234|FG001|Participant Flow|Treatment as Usual|Not receiving bupropion
10901676|NCT00572234|OG000|Outcome|Receiving Bupropion SR|"receiving bupropion SR 12 week course of bupropion SR 150 mg, BID~bupropion SR: 12 week course of bupropion SR 150 mg, BID"
10901677|NCT00572234|OG001|Outcome|Treatment as Usual|Not receiving bupropion
10901678|NCT00572234|EG000|Reported Event|Receiving Bupropion SR|"receiving bupropion SR~bupropion SR: 12 week course of bupropion SR 150 mg, BID"
10901679|NCT00572234|EG001|Reported Event|Treatment as Usual|Not receiving bupropion
10901680|NCT00572455|BG000|Baseline|Taprenepag 0.0025% (Stage I)|Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
10901681|NCT00572455|BG001|Baseline|Taprenepag 0.005% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901682|NCT00572455|BG002|Baseline|Taprenepag 0.01% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901683|NCT00572455|BG003|Baseline|Taprenepag 0.015% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901684|NCT00572455|BG004|Baseline|Taprenepag 0.02% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901685|NCT00572455|BG005|Baseline|Taprenepag 0.03% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901686|NCT00572455|BG006|Baseline|Taprenepag Vehicle (Stage I)|Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
10901687|NCT00572455|BG007|Baseline|Latanoprost Vehicle and Taprenepag 0.005% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901688|NCT00572455|BG008|Baseline|Latanoprost Vehicle and Taprenepag 0.01% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
11171971|NCT02006472|EG000|Reported Event|Placebo|"Pridopidine matching placebo (hard capsules)~Patients received a starting dose of pridopidine 22.5 mg or matching placebo and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26."
11171972|NCT02006472|EG001|Reported Event|Pridopidine 45 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26."
11171973|NCT02006472|EG002|Reported Event|Pridopidine 67.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26."
11171974|NCT02006472|EG003|Reported Event|Pridopidine 90 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26."
11171975|NCT02006472|EG004|Reported Event|Pridopidine 112.5 mg BID|"Pridopidine given as hard capsules, twice daily~Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26."
11171976|NCT02006576|BG000|Baseline|COPD, Placebo|"Placebo three times daily~Placebo three times daily"
11171977|NCT02006576|BG001|Baseline|Control Subject|Control subjects, no intervention
11171978|NCT02006576|BG002|Baseline|COPD, Ibuprofen|"600 mg ibuprofen three times daily for 48 weeks~600 mg ibuprofen three times daily for 48 weeks"
11171979|NCT02006576|BG003|Baseline|Total|Total of all reporting groups
11171980|NCT02006576|FG000|Participant Flow|COPD, Placebo|"Placebo three times daily~Placebo three times daily"
10901689|NCT00572455|BG009|Baseline|Latanoprost Vehicle and Taprenepag 0.015% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
11171981|NCT02006576|FG001|Participant Flow|Control Subject|Control subjects, no intervention
11171982|NCT02006576|FG002|Participant Flow|COPD, Ibuprofen|"600 mg ibuprofen three times daily for 48 weeks~600 mg ibuprofen three times daily for 48 weeks"
11171983|NCT02006576|OG000|Outcome|COPD, Placebo|"Placebo three times daily~Placebo three times daily"
11171984|NCT02006576|OG001|Outcome|Control Subject|Control subjects, no intervention
11171985|NCT02006576|OG002|Outcome|COPD, Ibuprofen|"600 mg ibuprofen three times daily for 48 weeks~600 mg ibuprofen three times daily for 48 weeks"
11171986|NCT02006576|EG000|Reported Event|COPD, Placebo|"Placebo three times daily~Placebo three times daily"
11171987|NCT02006576|EG001|Reported Event|Control Subject|Control subjects, no intervention
11171988|NCT02006576|EG002|Reported Event|COPD, Ibuprofen|"600 mg ibuprofen three times daily for 48 weeks~600 mg ibuprofen three times daily for 48 weeks"
11171989|NCT02006628|BG000|Baseline|GWP42003 1000 mg/Day|Participants received GWP42003 (100 mg/mL), 5 mL BID administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
11171990|NCT02006628|BG001|Baseline|Placebo|Participants received placebo (0 mL CBD), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
11171991|NCT02006628|BG002|Baseline|Total|Total of all reporting groups
11171992|NCT02006628|FG000|Participant Flow|GWP42003 1000 Milligram (mg)/Day|Participants received GWP42003 (100 mg/milliliter [mL]), 5 mL twice daily (BID) administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
11171993|NCT02006628|FG001|Participant Flow|Placebo|Participants received placebo (0 mL cannabidiol [CBD]), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
11171994|NCT02006628|OG000|Outcome|GWP42003 1000 mg/Day|Participants received GWP42003 (100 mg/mL), 5 mL BID administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
11171995|NCT02006628|OG001|Outcome|Placebo|Participants received placebo (0 mL CBD), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
11171996|NCT02006628|EG000|Reported Event|GWP42003 1000 mg/Day|Participants received GWP42003 (100 mg/mL), 5 mL BID administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
11171997|NCT02006628|EG001|Reported Event|Placebo|Participants received placebo (0 mL CBD), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
11171998|NCT02006641|BG000|Baseline|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
11171999|NCT02006641|BG001|Baseline|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11172000|NCT02006641|BG002|Baseline|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11172001|NCT02006641|BG003|Baseline|Total|Total of all reporting groups
11172002|NCT02006641|FG000|Participant Flow|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
11172003|NCT02006641|FG001|Participant Flow|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
10901690|NCT00572455|BG010|Baseline|Latanoprost 0.005% and Taprenepag 0.005% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901691|NCT00572455|BG011|Baseline|Latanoprost 0.005% and Taprenepag 0.01% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901692|NCT00572455|BG012|Baseline|Latanoprost 0.005% and Taprenepag 0.015% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901693|NCT00572455|BG013|Baseline|Latanoprost 0.005% and Taprenepag Vehicle (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901694|NCT00572455|BG014|Baseline|Total|Total of all reporting groups
10901695|NCT00572455|FG000|Participant Flow|Taprenepag 0.0025% (Stage I)|Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
10901696|NCT00572455|FG001|Participant Flow|Taprenepag 0.005% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901697|NCT00572455|FG002|Participant Flow|Taprenepag 0.01% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901698|NCT00572455|FG003|Participant Flow|Taprenepag 0.015% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901699|NCT00572455|FG004|Participant Flow|Taprenepag 0.02% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901700|NCT00572455|FG005|Participant Flow|Taprenepag 0.03% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901701|NCT00572455|FG006|Participant Flow|Taprenepag Vehicle (Stage I)|Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
10901702|NCT00572455|FG007|Participant Flow|Latanoprost Vehicle and Taprenepag 0.005% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901703|NCT00572455|FG008|Participant Flow|Latanoprost Vehicle and Taprenepag 0.01% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901704|NCT00572455|FG009|Participant Flow|Latanoprost Vehicle and Taprenepag 0.015% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901705|NCT00572455|FG010|Participant Flow|Latanoprost 0.005% and Taprenepag 0.005% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901706|NCT00572455|FG011|Participant Flow|Latanoprost 0.005% and Taprenepag 0.01% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901707|NCT00572455|FG012|Participant Flow|Latanoprost 0.005% and Taprenepag 0.015% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901708|NCT00572455|FG013|Participant Flow|Latanoprost 0.005% and Taprenepag Vehicle (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901709|NCT00572455|OG000|Outcome|Taprenepag 0.0025% (Stage I)|Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
10901710|NCT00572455|OG001|Outcome|Taprenepag 0.005% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901711|NCT00572455|OG002|Outcome|Taprenepag 0.01% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901712|NCT00572455|OG003|Outcome|Taprenepag 0.015% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901713|NCT00572455|OG004|Outcome|Taprenepag 0.02% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901714|NCT00572455|OG005|Outcome|Taprenepag 0.03% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901715|NCT00572455|OG006|Outcome|Taprenepag Vehicle (Stage I)|Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
10901716|NCT00572455|OG000|Outcome|Latanoprost Vehicle and Taprenepag 0.005% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901717|NCT00572455|OG001|Outcome|Latanoprost Vehicle and Taprenepag 0.01% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901718|NCT00572455|OG002|Outcome|Latanoprost Vehicle and Taprenepag 0.015% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901719|NCT00572455|OG003|Outcome|Latanoprost 0.005% and Taprenepag 0.005% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901720|NCT00572455|OG004|Outcome|Latanoprost 0.005% and Taprenepag 0.01% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901721|NCT00572455|OG005|Outcome|Latanoprost 0.005% and Taprenepag 0.015% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901722|NCT00572455|OG006|Outcome|Latanoprost 0.005% and Taprenepag Vehicle (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901723|NCT00572455|EG000|Reported Event|Taprenepag 0.0025% (Stage I)|Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
10901724|NCT00572455|EG001|Reported Event|Taprenepag 0.005% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901725|NCT00572455|EG002|Reported Event|Taprenepag 0.01% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901726|NCT00572455|EG003|Reported Event|Taprenepag 0.015% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901727|NCT00572455|EG004|Reported Event|Taprenepag 0.02% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901728|NCT00572455|EG005|Reported Event|Taprenepag 0.03% (Stage I)|Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
10901729|NCT00572455|EG006|Reported Event|Taprenepag Vehicle (Stage I)|Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
10901730|NCT00572455|EG007|Reported Event|Latanoprost Vehicle and Taprenepag 0.005% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901731|NCT00572455|EG008|Reported Event|Latanoprost Vehicle and Taprenepag 0.01% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901732|NCT00572455|EG009|Reported Event|Latanoprost Vehicle and Taprenepag 0.015% (Stage II)|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901733|NCT00572455|EG010|Reported Event|Latanoprost 0.005% and Taprenepag 0.005% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901734|NCT00572455|EG011|Reported Event|Latanoprost 0.005% and Taprenepag 0.01% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901735|NCT00572455|EG012|Reported Event|Latanoprost 0.005% and Taprenepag 0.015% (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901736|NCT00572455|EG013|Reported Event|Latanoprost 0.005% and Taprenepag Vehicle (Stage II)|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
10901737|NCT00572468|BG000|Baseline|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
10901738|NCT00572468|BG001|Baseline|Placebo|Participants were randomized into the placebo arm of this trial.
10901739|NCT00572468|BG002|Baseline|Total|Total of all reporting groups
10901740|NCT00572468|FG000|Participant Flow|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
10901741|NCT00572468|FG001|Participant Flow|Placebo|Participants were randomized into the placebo arm of this trial.
10901742|NCT00572468|OG000|Outcome|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
10901743|NCT00572468|OG001|Outcome|Placebo|Participants were randomized into the placebo arm of this trial.
10901744|NCT00572468|EG000|Reported Event|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
10901745|NCT00572468|EG001|Reported Event|Placebo|Participants were randomized into the placebo arm of this trial.
10901746|NCT00572533|BG000|Baseline|Control|ESA Dose Adjustment per standard Anemia Management Protocol
11233387|NCT02427399|OG000|Outcome|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
11233388|NCT02427399|OG001|Outcome|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient's primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
11233389|NCT02427399|OG002|Outcome|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider's email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
11233390|NCT02427399|OG003|Outcome|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
11233391|NCT02427399|OG004|Outcome|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
11233392|NCT02427399|EG000|Reported Event|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
11233393|NCT02427399|EG001|Reported Event|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient's primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
11233394|NCT02427399|EG002|Reported Event|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider's email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
10901747|NCT00572533|BG001|Baseline|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
10901748|NCT00572533|BG002|Baseline|Total|Total of all reporting groups
10901749|NCT00572533|FG000|Participant Flow|Control|ESA Dose Adjustment per standard Anemia Management Protocol
10901750|NCT00572533|FG001|Participant Flow|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
10901751|NCT00572533|OG000|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
10901752|NCT00572533|OG001|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
10901753|NCT00572533|EG000|Reported Event|Control|ESA Dose Adjustment per standard Anemia Management Protocol
10901754|NCT00572533|EG001|Reported Event|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
10901755|NCT00572572|BG000|Baseline|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
10901756|NCT00572572|BG001|Baseline|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
10901757|NCT00572572|BG002|Baseline|Total|Total of all reporting groups
10901758|NCT00572572|FG000|Participant Flow|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
10901759|NCT00572572|FG001|Participant Flow|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
10901760|NCT00572572|OG000|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
10901761|NCT00572572|OG001|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
10901762|NCT00572572|EG000|Reported Event|Aprepitant, Then Placebo|"Arm A, Study Cycle 1~Arm B, Study Cycle 2~Aprepitant: Aprepitant 125mg PO day 3 then 80mg on days 4 through 7~Subjects will be stratified prior to randomization based on previous administration of chemotherapy.~Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.~Arm A, Study Cycle 1~Arm B, Study Cycle 2"
10901763|NCT00572572|EG001|Reported Event|Placebo, Then Aprepitant.|"Arm A, Study Cycle 2~Arm B, Study Cycle 1~Placebo: Matched placebo PO daily on days 3 through 7~Subjects will be stratified prior to randomization based on previous administration of chemotherapy.~Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.~Arm A, Study Cycle 2~Arm B, Study Cycle 1"
10901764|NCT00572624|BG000|Baseline|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
10901765|NCT00572624|BG001|Baseline|Gastric Bypass Surgery|Participants who received gastric bypass surgery
10901766|NCT00572624|BG002|Baseline|Total|Total of all reporting groups
10901767|NCT00572624|FG000|Participant Flow|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
10901768|NCT00572624|FG001|Participant Flow|Gastric Bypass Surgery|Participants who received gastric bypass surgery
10901769|NCT00572624|OG000|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
10901770|NCT00572624|OG001|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
10901771|NCT00572624|EG000|Reported Event|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
10901772|NCT00572624|EG001|Reported Event|Gastric Bypass Surgery|Participants who received gastric bypass surgery
10901773|NCT00572728|BG000|Baseline|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
10901774|NCT00572728|FG000|Participant Flow|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
10901775|NCT00572728|OG000|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
10914948|NCT00633399|EG000|Reported Event|Ziprasidone + Escitalpram|"Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
10901776|NCT00572728|OG000|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post-NAC (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
10901777|NCT00572728|OG000|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~CT: Undergo 18F-FLT PET/CT~18F-FLT: Undergo 18F-FLT PET/CT~PET: Undergo 18F-FLT PET/CT"
10901778|NCT00572728|EG000|Reported Event|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
10901779|NCT00572832|BG000|Baseline|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
10901780|NCT00572832|BG001|Baseline|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
10901781|NCT00572832|BG002|Baseline|Total|Total of all reporting groups
10901782|NCT00572832|FG000|Participant Flow|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
10901783|NCT00572832|FG001|Participant Flow|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
10901784|NCT00572832|OG000|Outcome|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
10901785|NCT00572832|OG001|Outcome|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
10901786|NCT00572832|EG000|Reported Event|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
10901787|NCT00572832|EG001|Reported Event|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
10901788|NCT00572897|BG000|Baseline|Sibling Donor|Patients received a stem cell transplant from sibling
10901789|NCT00572897|BG001|Baseline|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
10901790|NCT00572897|BG002|Baseline|Total|Total of all reporting groups
10901791|NCT00572897|FG000|Participant Flow|Sibling Donor|Patients received a stem cell transplant from sibling
10901792|NCT00572897|FG001|Participant Flow|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
10901793|NCT00572897|OG000|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
10901794|NCT00572897|OG001|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
10901795|NCT00572897|EG000|Reported Event|Sibling Donor|Patients received a stem cell transplant from sibling
10901796|NCT00572897|EG001|Reported Event|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
10901797|NCT00572910|BG000|Baseline|V710 (60 mcg / 60 mcg)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
10901798|NCT00572910|BG001|Baseline|V710 (60 mcg / PBO)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28.
10901799|NCT00572910|BG002|Baseline|V710 (60 mcg / 60 mcg) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
10901800|NCT00572910|BG003|Baseline|V710 (60 mcg / PBO) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28.
10901801|NCT00572910|BG004|Baseline|V710 (90 mcg / 90 mcg) + MAA|Participants who were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
10901802|NCT00572910|BG005|Baseline|Placebo (PBO / PBO)|Participants who were vaccinated with Placebo on Day 1 and Day 28.
10901803|NCT00572910|BG006|Baseline|Total|Total of all reporting groups
10901804|NCT00572910|FG000|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
10901805|NCT00572910|FG001|Participant Flow|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
10901806|NCT00572910|FG002|Participant Flow|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
10901807|NCT00572910|FG003|Participant Flow|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
10901808|NCT00572910|FG004|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
10901809|NCT00572910|FG005|Participant Flow|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg /PBO) with MAA.
10901810|NCT00572910|FG006|Participant Flow|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
10901811|NCT00572910|FG007|Participant Flow|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
10901812|NCT00572910|FG008|Participant Flow|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
10901813|NCT00572910|FG009|Participant Flow|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
10901814|NCT00572910|FG010|Participant Flow|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
10901815|NCT00572910|OG000|Outcome|V710 (60 mcg Without MAA) - Group 1|Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
10901816|NCT00572910|OG001|Outcome|V710 (60 mcg With MAA) - Group 3|Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
10901817|NCT00572910|OG002|Outcome|V710 (90 mcg With MAA) - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
11172004|NCT02006641|FG002|Participant Flow|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11172005|NCT02006641|OG000|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
10901818|NCT00572910|OG000|Outcome|V710 - Group 1 and 2|"Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.~Participants Group 2 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
10901819|NCT00572910|OG001|Outcome|V710 - Group 3 and 4|"Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.~Participants in Group 4 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
10901820|NCT00572910|OG002|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
10901821|NCT00572910|OG000|Outcome|V710 - Group 1|Participants in Group 1 were vaccinated V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
10901822|NCT00572910|OG001|Outcome|V710 - Group 3|Participants in Group 2 were vaccinated V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
11172006|NCT02006641|OG001|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11172007|NCT02006641|OG002|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11172008|NCT02006641|EG000|Reported Event|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
11172009|NCT02006641|EG001|Reported Event|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11172010|NCT02006641|EG002|Reported Event|Idalopirdine 30 mg|"Idalopirdine adjunct to 20 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
11172011|NCT02006654|BG000|Baseline|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
11172012|NCT02006654|BG001|Baseline|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
11172013|NCT02006654|BG002|Baseline|Total|Total of all reporting groups
11172014|NCT02006654|FG000|Participant Flow|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
11172015|NCT02006654|FG001|Participant Flow|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an ACHEI~Idalopirdine: Once daily, encapsulated tablets, orally"
10901823|NCT00572910|OG002|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
10901824|NCT00572910|OG000|Outcome|V710 - Group 2|Participants in Group 2 were vaccinated V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
10901825|NCT00572910|OG001|Outcome|V710 - Group 4|Participants in Group 4 were vaccinated V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
10901826|NCT00572910|OG000|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
10901827|NCT00572910|OG001|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
10901828|NCT00572910|OG002|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
10901829|NCT00572910|OG003|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
10901830|NCT00572910|OG004|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
10901831|NCT00572910|OG005|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
10901832|NCT00572910|OG006|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
10901833|NCT00572910|OG007|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
10901834|NCT00572910|OG008|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
10901835|NCT00572910|OG009|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
10901836|NCT00572910|OG010|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
10901837|NCT00572910|EG000|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
10901838|NCT00572910|EG001|Reported Event|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
10901839|NCT00572910|EG002|Reported Event|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
10901840|NCT00572910|EG003|Reported Event|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
11172016|NCT02006654|OG000|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
11172017|NCT02006654|OG001|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an ACHEI~Idalopirdine: Once daily, encapsulated tablets, orally"
11172018|NCT02006654|OG001|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
11172019|NCT02006654|EG000|Reported Event|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
10901841|NCT00572910|EG004|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
10901842|NCT00572910|EG005|Reported Event|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
10901843|NCT00572910|EG006|Reported Event|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
10901844|NCT00572910|EG007|Reported Event|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
10901845|NCT00572910|EG008|Reported Event|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
10901846|NCT00572910|EG009|Reported Event|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
10901847|NCT00572910|EG010|Reported Event|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
10901848|NCT00572936|BG000|Baseline|Latanoprost/Dorzolamide/Timolol|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
10901849|NCT00572936|FG000|Participant Flow|Latanoprost/Dorzolamide/Timolol|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
10901850|NCT00572936|FG001|Participant Flow|Latanoprost/Timolol/Dorzolamide|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
11172020|NCT02006654|EG001|Reported Event|Idalopirdine 60 mg|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
11172021|NCT02006667|BG000|Baseline|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
10901851|NCT00572936|FG002|Participant Flow|Dorzolamide/Latanoprost/Timolol|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
10901852|NCT00572936|FG003|Participant Flow|Dorzolamide/Timolol/Latanoprost|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
10901853|NCT00572936|FG004|Participant Flow|Timolol/Dorzolamide/Latanoprost|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
10901854|NCT00572936|FG005|Participant Flow|Timolol/Latanoprost/Dorzolamide|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
10901855|NCT00572936|OG000|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
10901856|NCT00572936|OG001|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
10901857|NCT00572936|OG002|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
10901858|NCT00572936|EG000|Reported Event|Latanoprost|The participants received latanoprost at night and vehicle in the morning for two weeks,
10901859|NCT00572936|EG001|Reported Event|Dorzolamide|Dorzolamide BID for two weeks,
10901860|NCT00572936|EG002|Reported Event|Timolol|Timolol BID for two weeks
10901861|NCT00573066|BG000|Baseline|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
10901862|NCT00573066|FG000|Participant Flow|Dexmedetomidine Dose Escalation Cohorts|"Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
10901863|NCT00573066|OG000|Outcome|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
10901864|NCT00573066|EG000|Reported Event|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
10901865|NCT00573144|BG000|Baseline|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
10901866|NCT00573144|BG001|Baseline|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
10901867|NCT00573144|BG002|Baseline|Total|Total of all reporting groups
10901868|NCT00573144|FG000|Participant Flow|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
10901869|NCT00573144|FG001|Participant Flow|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
10901870|NCT00573144|OG000|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
10901871|NCT00573144|OG001|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
10901872|NCT00573144|EG000|Reported Event|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
10901873|NCT00573144|EG001|Reported Event|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
10901874|NCT00573170|BG000|Baseline|All Study Participants Treated at Least Once|All study participants who were treated at least once with study medication
10901875|NCT00573170|FG000|Participant Flow|Treximet, Placebo, Butalbital-containing Combo. Medication|Fixed dose combination (combo.) tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
10901876|NCT00573170|FG001|Participant Flow|Treximet, Butalbital-containing Combo. Medication, Placebo|Fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
10901877|NCT00573170|FG002|Participant Flow|Butalbital-containing Combo. Medication, Treximet, Placebo|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
10901878|NCT00573170|FG003|Participant Flow|Butalbital-containing Combo. Medication, Placebo, Treximet|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
10901879|NCT00573170|FG004|Participant Flow|Placebo, Treximet, Butalbital-containing Combo. Medication|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
10901880|NCT00573170|FG005|Participant Flow|Placebo, Butalbital-containing Combo. Medication, Treximet|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
10901881|NCT00573170|OG000|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
10901882|NCT00573170|OG001|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
10901883|NCT00573170|OG002|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
10901884|NCT00573170|OG000|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with placebo
11172022|NCT02006667|FG000|Participant Flow|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
10901885|NCT00573170|OG001|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Treximet
10901886|NCT00573170|OG002|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Butalbital-containing combination medication
10901887|NCT00573170|OG000|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with placebo
10901888|NCT00573170|OG001|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Treximet
10901889|NCT00573170|OG002|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Butalbital-containing combination medication
10901890|NCT00573170|OG000|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with placebo
10901891|NCT00573170|OG001|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Treximet
11172023|NCT02006667|OG000|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
10901892|NCT00573170|OG002|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Butalbital-containing combination medication
10901893|NCT00573170|EG000|Reported Event|Placebo|Participants who reported an SAE anytime after initial treatment with blinded placebo, but before another initial treatment with any other investigational product
10901894|NCT00573170|EG001|Reported Event|Treximet|Participants who reported an SAE anytime after initial treatment with blinded Treximet, but before another initial treatment with any other investigational product
10901895|NCT00573170|EG002|Reported Event|Butalbital-containing Combination Medication|Participants who reported an SAE anytime after initial treatment with blinded Butalbital-containing combination medication, but before another initial treatment with any other investigational product
11172024|NCT02006667|EG000|Reported Event|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
11172025|NCT02006693|BG000|Baseline|XEN® Gel Stent|The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
10901896|NCT00573183|BG000|Baseline|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
10901897|NCT00573183|BG001|Baseline|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
10901898|NCT00573183|BG002|Baseline|Total|Total of all reporting groups
10901899|NCT00573183|FG000|Participant Flow|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
10901900|NCT00573183|FG001|Participant Flow|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
10901901|NCT00573183|OG000|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
10901902|NCT00573183|OG001|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
10901903|NCT00573183|OG000|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
10901904|NCT00573183|OG001|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
10901905|NCT00573183|EG000|Reported Event|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
10901906|NCT00573183|EG001|Reported Event|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
10901907|NCT00573248|BG000|Baseline|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
10901908|NCT00573248|BG001|Baseline|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
10901909|NCT00573248|BG002|Baseline|Total|Total of all reporting groups
10901910|NCT00573248|FG000|Participant Flow|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
10901911|NCT00573248|FG001|Participant Flow|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
10901912|NCT00573248|OG000|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
10901913|NCT00573248|OG001|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
10901914|NCT00573248|EG000|Reported Event|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
10901915|NCT00573248|EG001|Reported Event|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
10901916|NCT00573261|BG000|Baseline|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
10901917|NCT00573261|BG001|Baseline|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
10901918|NCT00573261|BG002|Baseline|Total|Total of all reporting groups
10901919|NCT00573261|FG000|Participant Flow|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
10901920|NCT00573261|FG001|Participant Flow|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
10901921|NCT00573261|OG000|Outcome|Placebo|Placebo
10901922|NCT00573261|OG001|Outcome|Pregabalin|Pregabalin
10901923|NCT00573261|OG000|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
10901924|NCT00573261|OG001|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
10901925|NCT00573261|EG000|Reported Event|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
10901926|NCT00573261|EG001|Reported Event|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
10901927|NCT00573287|BG000|Baseline|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
10901928|NCT00573287|BG001|Baseline|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
10901929|NCT00573287|BG002|Baseline|Total|Total of all reporting groups
10901930|NCT00573287|FG000|Participant Flow|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
10901931|NCT00573287|FG001|Participant Flow|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
10901932|NCT00573287|OG000|Outcome|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
10901933|NCT00573287|OG001|Outcome|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
10901934|NCT00573287|EG000|Reported Event|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
10901935|NCT00573287|EG001|Reported Event|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
10901936|NCT00573313|BG000|Baseline|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
10901937|NCT00573313|BG001|Baseline|Healthy|Healthy subjects without alcoholism or liver disease.
10901938|NCT00573313|BG002|Baseline|Lifestyle Counseling|Active drinkers non liver disease subjects
10901939|NCT00573313|BG003|Baseline|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
10901940|NCT00573313|BG004|Baseline|Total|Total of all reporting groups
10901941|NCT00573313|FG000|Participant Flow|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
10901942|NCT00573313|FG001|Participant Flow|Healthy|Subjects were enrolled into this arm for baseline measurement only.
10901943|NCT00573313|FG002|Participant Flow|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
10901944|NCT00573313|FG003|Participant Flow|Lifestyle Counseling|Subjects were enrolled into this arm for baseline measurements only.
10901945|NCT00573313|OG000|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
10901946|NCT00573313|OG001|Outcome|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
10901947|NCT00573313|OG001|Outcome|Sugar Pill|ALD subjects receiving placebo sugar pill three times daily for 24 weeks.
10901948|NCT00573313|EG000|Reported Event|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
10901949|NCT00573313|EG001|Reported Event|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
11172026|NCT02006693|BG001|Baseline|XEN® Gel Stent With Cataract Surgery|The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
11172027|NCT02006693|BG002|Baseline|Total|Total of all reporting groups
10901950|NCT00573430|BG000|Baseline|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
10901951|NCT00573430|BG001|Baseline|Candesartan 16mg|Candesartan 16mg oral once daily dose
10901952|NCT00573430|BG002|Baseline|Candesartan 32mg|Candesartan 32mg oral once daily dose
10901953|NCT00573430|BG003|Baseline|Total|Total of all reporting groups
10901954|NCT00573430|FG000|Participant Flow|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
10901955|NCT00573430|FG001|Participant Flow|Candesartan 16mg|Candesartan 16mg oral once daily dose
10901956|NCT00573430|FG002|Participant Flow|Candesartan 32mg|Candesartan 32mg oral once daily dose
10901957|NCT00573430|OG000|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
10901958|NCT00573430|OG001|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
10901959|NCT00573430|OG002|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
10901960|NCT00573430|EG000|Reported Event|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
10901961|NCT00573430|EG001|Reported Event|Candesartan 16mg|Candesartan 16mg oral once daily dose
10901962|NCT00573430|EG002|Reported Event|Candesartan 32mg|Candesartan 32mg oral once daily dose
10901963|NCT00573443|BG000|Baseline|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901964|NCT00573443|BG001|Baseline|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901965|NCT00573443|BG002|Baseline|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901966|NCT00573443|BG003|Baseline|Total|Total of all reporting groups
10901967|NCT00573443|FG000|Participant Flow|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901968|NCT00573443|FG001|Participant Flow|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901969|NCT00573443|FG002|Participant Flow|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901970|NCT00573443|OG000|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901971|NCT00573443|OG001|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901972|NCT00573443|OG002|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
10901973|NCT00573443|EG000|Reported Event|AVP-923-30 (Double-blind)|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period.
10901974|NCT00573443|EG001|Reported Event|AVP-923-20 (Double-blind)|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
10901975|NCT00573443|EG002|Reported Event|Placebo (Double-blind)|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
10901976|NCT00573443|EG003|Reported Event|AVP-923-30 (Open Label)|Optional 12-week Open Label phase for subjects who completed 12-week DB phase.
10901977|NCT00573469|BG000|Baseline|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
10901978|NCT00573469|BG001|Baseline|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
10901979|NCT00573469|BG002|Baseline|Placebo|An enteric capsule without D9421-C was given once daily.
10901980|NCT00573469|BG003|Baseline|Total|Total of all reporting groups
10901981|NCT00573469|FG000|Participant Flow|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
10901982|NCT00573469|FG001|Participant Flow|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
10901983|NCT00573469|FG002|Participant Flow|Placebo|An enteric capsule without D9421-C was given once daily.
10901984|NCT00573469|OG000|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
10901985|NCT00573469|OG001|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
10901986|NCT00573469|OG002|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
10901987|NCT00573469|EG000|Reported Event|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
10901988|NCT00573469|EG001|Reported Event|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
10901989|NCT00573469|EG002|Reported Event|Placebo|An enteric capsule without D9421-C was given once daily.
10901990|NCT00573508|BG000|Baseline|Placebo|Matching placebo tablet taken once daily
10901991|NCT00573508|BG001|Baseline|Solifenacin Succinate|5mg or 10mg tablet taken once daily
10901992|NCT00573508|BG002|Baseline|Total|Total of all reporting groups
10901993|NCT00573508|FG000|Participant Flow|Placebo|Matching placebo tablet taken once daily
10901994|NCT00573508|FG001|Participant Flow|Solifenacin Succinate|5mg or 10mg tablet taken once daily
10901995|NCT00573508|OG000|Outcome|Placebo|Matching placebo tablet taken once daily
10901996|NCT00573508|OG001|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
10901997|NCT00573508|EG000|Reported Event|Placebo|Matching placebo tablet taken once daily
10901998|NCT00573508|EG001|Reported Event|Solifenacin Succinate|5mg or 10mg tablet taken once daily
10901999|NCT00573534|BG000|Baseline|Group 1|Adolescents with ADHD and an older sibling with substance use disorder
10902000|NCT00573534|FG000|Participant Flow|Group 1|Adolescents with ADHD and an older sibling with Substance Use Disorder
10902001|NCT00573534|OG000|Outcome|Group 1|Lisdexamfetamine and family counseling
10902002|NCT00573534|OG000|Outcome|Lisdexamfetamine Plus Family Therapy|patients received lisdexamfetamine up to 70 mgs plus family counseling
10902003|NCT00573534|EG000|Reported Event|Group 1|Intervention with Vyvanse
10902004|NCT00573755|BG000|Baseline|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10902005|NCT00573755|BG001|Baseline|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10902006|NCT00573755|BG002|Baseline|Total|Total of all reporting groups
10902007|NCT00573755|FG000|Participant Flow|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10902008|NCT00573755|FG001|Participant Flow|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10902009|NCT00573755|OG000|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10902010|NCT00573755|OG001|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10902011|NCT00573755|EG000|Reported Event|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10902012|NCT00573755|EG001|Reported Event|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10902013|NCT00573768|BG000|Baseline|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
10902014|NCT00573768|BG001|Baseline|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
10902015|NCT00573768|BG002|Baseline|Vehicle Gel|BID application
10902016|NCT00573768|BG003|Baseline|Total|Total of all reporting groups
10902017|NCT00573768|FG000|Participant Flow|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
10902018|NCT00573768|FG001|Participant Flow|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
10902019|NCT00573768|FG002|Participant Flow|Vehicle Gel|BID application
10902020|NCT00573768|OG000|Outcome|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
10902021|NCT00573768|OG001|Outcome|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
10902022|NCT00573768|OG002|Outcome|Vehicle Gel|BID application
10902023|NCT00573768|EG000|Reported Event|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
10902024|NCT00573768|EG001|Reported Event|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
10902025|NCT00573768|EG002|Reported Event|Vehicle Gel|BID application
10902026|NCT00573794|BG000|Baseline|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
10902027|NCT00573794|FG000|Participant Flow|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
10902028|NCT00573794|OG000|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
10902029|NCT00573794|EG000|Reported Event|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
10902030|NCT00573833|BG000|Baseline|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
10902031|NCT00573833|FG000|Participant Flow|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
10902032|NCT00573833|OG000|Outcome|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
10902033|NCT00573833|EG000|Reported Event|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
10902034|NCT00573859|BG000|Baseline|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
10902035|NCT00573859|FG000|Participant Flow|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
10902036|NCT00573859|OG000|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
10902037|NCT00573859|EG000|Reported Event|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
10902038|NCT00573872|BG000|Baseline|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
11172028|NCT02006693|FG000|Participant Flow|XEN® Gel Stent|The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
10902039|NCT00573872|FG000|Participant Flow|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
10902040|NCT00573872|OG000|Outcome|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
10902041|NCT00573872|EG000|Reported Event|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
10902042|NCT00573989|BG000|Baseline|Erlotinib|"Erlotinib~erlotinib hydrochloride~pemetrexed disodium~quality-of-life assessment~intensity-modulated radiation therapy"
10902043|NCT00573989|FG000|Participant Flow|Erlotinib 100mg|Participants will be given 100mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
10902044|NCT00573989|FG001|Participant Flow|Erlotinib 125mg|Participants will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
10902045|NCT00573989|FG002|Participant Flow|Erlotinib 150mg|Participants will be given 150mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
10902046|NCT00573989|FG003|Participant Flow|Erlotinib 125mg- Phase II|Participants in phase II will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
10902047|NCT00573989|OG000|Outcome|Erlotinib|"Erlotinib~erlotinib hydrochloride~pemetrexed disodium~quality-of-life assessment~intensity-modulated radiation therapy"
10902048|NCT00573989|EG000|Reported Event|Erlotinib 100 mg|Participants will be given 100mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
10902049|NCT00573989|EG001|Reported Event|Erlotinib 125mg|Participants will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
10902050|NCT00573989|EG002|Reported Event|Erlotinib 150mg|Participants will be given 150mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
10902051|NCT00573989|EG003|Reported Event|Erlotinib 125mg Phase II|Participants in phase II will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
11335636|NCT03554018|FG000|Participant Flow|Acetaminophen|"Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.~Acetaminophen: Acetaminophen 500-1000mg every 6 hours~Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10902052|NCT00574067|BG000|Baseline|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
10902053|NCT00574067|BG001|Baseline|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902054|NCT00574067|BG002|Baseline|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902055|NCT00574067|BG003|Baseline|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902056|NCT00574067|BG004|Baseline|Total|Total of all reporting groups
10902057|NCT00574067|FG000|Participant Flow|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
10902058|NCT00574067|FG001|Participant Flow|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902059|NCT00574067|FG002|Participant Flow|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902060|NCT00574067|FG003|Participant Flow|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
11090866|NCT01531998|FG000|Participant Flow|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
11090867|NCT01531998|OG000|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
11090868|NCT01531998|EG000|Reported Event|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
11090869|NCT01532089|BG000|Baseline|Arm A (Erlotinib Hydrochloride)|Patients receive 150 mg erlotinib hydrochloride PO QD on days 1-21.
11090870|NCT01532089|BG001|Baseline|Arm B (Erlotinib Hydrochloride, Bevacizumab)|Patients receive 150 mg erlotinib hydrochloride as in Arm A and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1.
11090871|NCT01532089|BG002|Baseline|Total|Total of all reporting groups
11090872|NCT01532089|FG000|Participant Flow|Arm A (Erlotinib Hydrochloride)|Patients receive 150 mg erlotinib hydrochloride PO QD on days 1-21.
11090873|NCT01532089|FG001|Participant Flow|Arm B (Erlotinib Hydrochloride, Bevacizumab)|Patients receive 150 mg erlotinib hydrochloride as in Arm A and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1.
11090874|NCT01532089|OG000|Outcome|Arm A (Erlotinib Hydrochloride)|Patients receive 150 mg erlotinib hydrochloride PO QD on days 1-21.
10902061|NCT00574067|OG000|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
10902062|NCT00574067|OG001|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902063|NCT00574067|OG002|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902064|NCT00574067|OG003|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
11090875|NCT01532089|OG001|Outcome|Arm B (Erlotinib Hydrochloride, Bevacizumab)|Patients receive 150 mg erlotinib hydrochloride as in Arm A and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1.
11090876|NCT01532089|OG000|Outcome|Exon 19 Deletion|Patients with exon 19 deletion EGFR exon mutation.
11090877|NCT01532089|OG001|Outcome|Exon 21 L858R|Patients with exon 21 L858R EGFR exon mutation.
11090878|NCT01532089|EG000|Reported Event|Arm A (Erlotinib Hydrochloride)|Patients receive 150 mg erlotinib hydrochloride PO QD on days 1-21.
11090879|NCT01532089|EG001|Reported Event|Arm B (Erlotinib Hydrochloride, Bevacizumab)|Patients receive 150 mg erlotinib hydrochloride as in Arm A and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1.
11090880|NCT01532128|BG000|Baseline|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
11090881|NCT01532128|BG001|Baseline|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
11090882|NCT01532128|BG002|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
10902065|NCT00574067|OG000|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
10902066|NCT00574067|OG001|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902067|NCT00574067|OG002|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902068|NCT00574067|OG003|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902069|NCT00574067|EG000|Reported Event|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
10902070|NCT00574067|EG001|Reported Event|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902071|NCT00574067|EG002|Reported Event|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902072|NCT00574067|EG003|Reported Event|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
10902073|NCT00574119|BG000|Baseline|Results With Spironolactone|"patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.~spironolactone: spironolactone 50 mg daily for 6 months"
10902074|NCT00574119|FG000|Participant Flow|Results With Spironolactone|"patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.~spironolactone: spironolactone 50 mg daily for 6 months"
10902075|NCT00574119|OG000|Outcome|Results With Spironolactone|"patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.~spironolactone: spironolactone 50 mg daily for 6 months"
10902076|NCT00574119|EG000|Reported Event|Results With Spironolactone|"patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.~spironolactone: spironolactone 50 mg daily for 6 months"
10902077|NCT00574145|BG000|Baseline|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
10902078|NCT00574145|BG001|Baseline|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
10902079|NCT00574145|BG002|Baseline|Total|Total of all reporting groups
11342300|NCT03704376|EG000|Reported Event|Femoral Nerve Blockade|"Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.~30 ml of 0.2% ropivacaine~100 mcg clonidine~High-frequency linear ultrasound transducer"
11090883|NCT01532128|BG003|Baseline|Total|Total of all reporting groups
10902080|NCT00574145|FG000|Participant Flow|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
10902081|NCT00574145|FG001|Participant Flow|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
10902082|NCT00574145|OG000|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
10902083|NCT00574145|OG001|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
10902084|NCT00574145|EG000|Reported Event|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
10902085|NCT00574145|EG001|Reported Event|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
10902086|NCT00574171|BG000|Baseline|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
10902087|NCT00574171|FG000|Participant Flow|Lapatinib and Capecitabine|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
10902088|NCT00574171|OG000|Outcome|Lapatinib/Capecitabine|lapatinib: 1250mg by mouth daily one hour before or after breakfast on a continuous basis. Capecitabine: 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
10902089|NCT00574171|EG000|Reported Event|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
10902090|NCT00574197|BG000|Baseline|Enteric-coated Mycophenolate Sodium (Myfortic)|1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
10902091|NCT00574197|FG000|Participant Flow|Enteric-coated Mycophenolate Sodium (Myfortic)|1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
11342301|NCT03704376|EG001|Reported Event|Adductor Canal Blockade|"Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).~15 ml of 0.2% ropivacaine~100 mcg clonidine~High-frequency linear ultrasound transducer"
10902092|NCT00574197|OG000|Outcome|Enteric-coated Mycophenolate Sodium (Myfortic)|1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
10902093|NCT00574197|EG000|Reported Event|Enteric-coated Mycophenolate Sodium (Myfortic)|"Enteric-coated Mycophenolate Sodium (Myfortic)~1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months"
10902094|NCT00574236|BG000|Baseline|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
10902095|NCT00574236|FG000|Participant Flow|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
10914949|NCT00633399|EG001|Reported Event|Ziprasidone + Placebo|"Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
11090884|NCT01532128|FG000|Participant Flow|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
11090885|NCT01532128|FG001|Participant Flow|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
11090886|NCT01532128|FG002|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
11090887|NCT01532128|OG000|Outcome|Rasagiline Alone|Rasagiline alone.
11090888|NCT01532128|OG001|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
11090889|NCT01532128|OG002|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
11090890|NCT01532128|EG000|Reported Event|Before Treatment|
11090891|NCT01532128|EG001|Reported Event|Rasagiline Alone|
11090892|NCT01532128|EG002|Reported Event|Rasagiline 1 h After BIA 9-1067|
11090893|NCT01532128|EG003|Reported Event|Rasagiline Concomitant BIA 9-1067|
11090894|NCT01532141|BG000|Baseline|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
11090895|NCT01532141|BG001|Baseline|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
11090896|NCT01532141|BG002|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
11090897|NCT01532141|BG003|Baseline|Total|Total of all reporting groups
11090898|NCT01532141|FG000|Participant Flow|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
11090899|NCT01532141|FG001|Participant Flow|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
11090900|NCT01532141|FG002|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
11090901|NCT01532141|OG000|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
11090902|NCT01532141|OG001|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
11090903|NCT01532141|OG002|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
11090904|NCT01532141|EG000|Reported Event|Before Treatment|Before treatment.
11090905|NCT01532141|EG001|Reported Event|BIA 9-1067 Alone|BIA 9-1067 alone.
11090906|NCT01532141|EG002|Reported Event|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
10902096|NCT00574236|OG000|Outcome|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
10902097|NCT00574236|EG000|Reported Event|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
10902098|NCT00574249|BG000|Baseline|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
10902099|NCT00574249|BG001|Baseline|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
10902100|NCT00574249|BG002|Baseline|Total|Total of all reporting groups
10902101|NCT00574249|FG000|Participant Flow|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week)
10902102|NCT00574249|FG001|Participant Flow|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)
10902103|NCT00574249|OG000|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
10902104|NCT00574249|OG001|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
11342282|NCT03704194|BG000|Baseline|Adapted LiFE|"Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar."
10902105|NCT00574249|EG000|Reported Event|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
10902106|NCT00574249|EG001|Reported Event|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
10902107|NCT00574275|BG000|Baseline|Placebo/Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
10902108|NCT00574275|BG001|Baseline|Aflibercept/Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
10902109|NCT00574275|BG002|Baseline|Total|Total of all reporting groups
10902110|NCT00574275|FG000|Participant Flow|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
10902111|NCT00574275|FG001|Participant Flow|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
10902112|NCT00574275|OG000|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
10902113|NCT00574275|OG001|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
10902114|NCT00574275|EG000|Reported Event|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
10902115|NCT00574275|EG001|Reported Event|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
10902116|NCT00574288|BG000|Baseline|Part 1 - <4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902117|NCT00574288|BG001|Baseline|Part 1 - 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902118|NCT00574288|BG002|Baseline|Part 1 - 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902119|NCT00574288|BG003|Baseline|Part 1 - 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902120|NCT00574288|BG004|Baseline|Part 1 - 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902121|NCT00574288|BG005|Baseline|Part 2 - 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
10902122|NCT00574288|BG006|Baseline|Part 2 - 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902123|NCT00574288|BG007|Baseline|Total|Total of all reporting groups
10902124|NCT00574288|FG000|Participant Flow|Part 1 - <4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902125|NCT00574288|FG001|Participant Flow|Part 1 - 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902126|NCT00574288|FG002|Participant Flow|Part 1 - 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902127|NCT00574288|FG003|Participant Flow|Part 1 - 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
11342112|NCT03697122|FG000|Participant Flow|HHBC and Forced Air Warming|"Patients admitted to intensive care unit hypothermic (≤ 35 C) following surgical procedures involving cardiopulmonary bypass. Will be rewarmed with heated humidified breathing circuits (ANAPOD) and standard forced air warming blankets.~Heated Humidified Breathing Circuit and Forced Air Blanket: Heated humidified breathing circuits (ANAPOD) will be set up and managed by respiratory therapist in standard fashion defined by the manufacturer. Temperate will be set at 41C.~Forced air warming blankets will be set at 42C for duration of rewarming."
10902128|NCT00574288|FG004|Participant Flow|Part 1 - 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902129|NCT00574288|FG005|Participant Flow|Part 2 - 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
10902130|NCT00574288|FG006|Participant Flow|Part 2 - 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902131|NCT00574288|OG000|Outcome|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902132|NCT00574288|OG001|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
11090907|NCT01532141|EG003|Reported Event|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
10902133|NCT00574288|OG002|Outcome|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10914950|NCT00633464|BG000|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
10902134|NCT00574288|OG003|Outcome|Part 1: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902135|NCT00574288|OG004|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902136|NCT00574288|OG005|Outcome|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
10902137|NCT00574288|OG006|Outcome|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902138|NCT00574288|OG000|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902139|NCT00574288|OG001|Outcome|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902140|NCT00574288|OG002|Outcome|Part 1: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902141|NCT00574288|OG003|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902142|NCT00574288|OG004|Outcome|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
10902143|NCT00574288|OG005|Outcome|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902144|NCT00574288|OG001|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions.
10902145|NCT00574288|OG002|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
11172029|NCT02006693|FG001|Participant Flow|XEN® Gel Stent With Cataract Surgery|The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
10902146|NCT00574288|OG000|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
10902147|NCT00574288|OG001|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
11172030|NCT02006693|OG000|Outcome|XEN® Gel Stent|The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
10902148|NCT00574288|EG000|Reported Event|Part 1 - <4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902149|NCT00574288|EG001|Reported Event|Part 1 - 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902150|NCT00574288|EG002|Reported Event|Part 1 - 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902151|NCT00574288|EG003|Reported Event|Part 1 - 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902152|NCT00574288|EG004|Reported Event|Part 1 - 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902153|NCT00574288|EG005|Reported Event|Part 2 - 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
10902154|NCT00574288|EG006|Reported Event|Part 2 - 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
10902155|NCT00574340|BG000|Baseline|All Study Participants|
10902156|NCT00574340|FG000|Participant Flow|Control Study Then Antecedent Hypoglycemia Study Group|Day 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia
10902157|NCT00574340|FG001|Participant Flow|Antecedent Hypoglycemia Group Then Control Study|Day 1 hypoglycemia, Day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, day 2 hypoglycemia
10902158|NCT00574340|OG000|Outcome|Control Group|"Day 1 euglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
10902159|NCT00574340|OG001|Outcome|Antecedent Hypoglycemia Group|"Day 1 hypoglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
10902160|NCT00574340|EG000|Reported Event|Control Group- All Participants|"Day 1 euglycemia, day 2 hypoglycemia= one study~Hyperinsulinemic Euglycemic Clamp study: each two day study (arm) separated by 8 weeks"
10902161|NCT00574340|EG001|Reported Event|Antecedent Hypoglycemia Group-all Participants|"Day 1 hypoglycemia, day 2 hypoglycemia= one study~Hyperinsulinemic Hypoglycemic Clamp study: each two day study (arm) separated by 8 weeks"
10902162|NCT00574405|BG000|Baseline|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
10902163|NCT00574405|BG001|Baseline|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
10902164|NCT00574405|BG002|Baseline|Total|Total of all reporting groups
10902165|NCT00574405|FG000|Participant Flow|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
11172031|NCT02006693|OG001|Outcome|XEN® Gel Stent With Cataract Surgery|The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
10902166|NCT00574405|FG001|Participant Flow|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
10902167|NCT00574405|OG000|Outcome|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
10902168|NCT00574405|OG001|Outcome|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
11172032|NCT02006693|EG000|Reported Event|XEN® Gel Stent|The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
11172033|NCT02006693|EG001|Reported Event|XEN® Gel Stent With Cataract Surgery|The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
10902169|NCT00574405|EG000|Reported Event|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
10902170|NCT00574405|EG001|Reported Event|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
10902171|NCT00574548|BG000|Baseline|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
10902172|NCT00574548|BG001|Baseline|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
10902173|NCT00574548|BG002|Baseline|Total|Total of all reporting groups
10902174|NCT00574548|FG000|Participant Flow|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
10902175|NCT00574548|FG001|Participant Flow|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
10902176|NCT00574548|OG000|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
10902177|NCT00574548|OG001|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
10902178|NCT00574548|OG001|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
10902179|NCT00574548|OG000|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
10902180|NCT00574548|OG001|Outcome|13vPnC / 13vPnC Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
10902181|NCT00574548|OG001|Outcome|13vPnC / 23vPS Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
10902182|NCT00574548|OG000|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
10902183|NCT00574548|OG001|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
10902184|NCT00574548|OG000|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
10902185|NCT00574548|OG001|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
10902186|NCT00574548|OG000|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
10902187|NCT00574548|OG002|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
10902188|NCT00574548|EG000|Reported Event|13vPnC (Year 0)|"Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=90; systematic (solicited) Local Reactions N=256; systematic (solicited) Systemic Events N=163."
10902189|NCT00574548|EG001|Reported Event|23vPS (Year 0)|"Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=49; systematic (solicited) Local Reactions N=102; systematic (solicited) Systemic Events N=86."
10902190|NCT00574548|EG002|Reported Event|13vPnC: 6 Month Follow-up After Vax 1 (Year 0)|Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
10902191|NCT00574548|EG003|Reported Event|23vPS: 6 Month Follow-up After Vax 1 (Year 0)|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
11090908|NCT01532349|BG000|Baseline|400 IU Vitamin D|Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
11090909|NCT01532349|BG001|Baseline|4000 IU Vitamin D|Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
11090910|NCT01532349|BG002|Baseline|Total|Total of all reporting groups
11090911|NCT01532349|FG000|Participant Flow|400 IU Vitamin D|Children will be randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
11090912|NCT01532349|FG001|Participant Flow|4000 IU Vitamin D|Children will be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
11090913|NCT01532349|OG000|Outcome|400 IU Vitamin D|"Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
11090914|NCT01532349|OG001|Outcome|4000 IU Vitamin D|"Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
11090915|NCT01532349|EG000|Reported Event|400 IU Vitamin D|"Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
11090916|NCT01532349|EG001|Reported Event|4000 IU Vitamin D|"Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
10902192|NCT00574548|EG004|Reported Event|13vPnC / 13vPnC (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=22; systematic (solicited) Local Reactions N=97; systematic (solicited) Systemic Events N=54."
10902193|NCT00574548|EG005|Reported Event|13vPnC / 23vPS (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=50; systematic (solicited) Local Reactions N=198; systematic (solicited) Systemic Events N=120."
10902194|NCT00574548|EG006|Reported Event|23vPS / 13vPnC (Year 1)|"23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=32; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=68."
10902195|NCT00574548|EG007|Reported Event|13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
10902196|NCT00574548|EG008|Reported Event|13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
10902197|NCT00574548|EG009|Reported Event|23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
11090917|NCT01532388|BG000|Baseline|eScreen|"Web based self-monitoring of problematic alcohol and drug use.~eScreen: Web based self-monitoring of problematic alcohol and drug use."
11090918|NCT01532388|BG001|Baseline|Control Group|Untreated control group
11090919|NCT01532388|BG002|Baseline|Total|Total of all reporting groups
11090920|NCT01532388|FG000|Participant Flow|eScreen|"Web based self-monitoring of problematic alcohol and drug use.~eScreen: Web based self-monitoring of problematic alcohol and drug use."
11090921|NCT01532388|FG001|Participant Flow|Control Group|Untreated control group
11090922|NCT01532388|OG000|Outcome|eScreen|"Web based self-monitoring of problematic alcohol and drug use.~eScreen: Web based self-monitoring of problematic alcohol and drug use."
11090923|NCT01532388|OG001|Outcome|Control Group|Untreated control group
11090924|NCT01532388|EG000|Reported Event|eScreen|"Web based self-monitoring of problematic alcohol and drug use.~eScreen: Web based self-monitoring of problematic alcohol and drug use."
11090925|NCT01532388|EG001|Reported Event|Control Group|Untreated control group
11090926|NCT01532414|BG000|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
11090927|NCT01532414|BG001|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11090928|NCT01532414|BG002|Baseline|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
11090929|NCT01532414|BG003|Baseline|Total|Total of all reporting groups
11090930|NCT01532414|FG000|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
10902198|NCT00574587|BG000|Baseline|Stratum A (HER2-positive): Dose Level 1|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 200 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902199|NCT00574587|BG001|Baseline|Stratum A (HER2-positive): Dose Level 2|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902200|NCT00574587|BG002|Baseline|Stratum B: Triple Negative|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902201|NCT00574587|BG003|Baseline|Stratum C: ER-Positive, HER2-Negative|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902202|NCT00574587|BG004|Baseline|Total|Total of all reporting groups
10902203|NCT00574587|FG000|Participant Flow|Stratum A (HER2-positive): Dose Level 1|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 200 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902204|NCT00574587|FG001|Participant Flow|Stratum A (HER2-positive): Dose Level 2|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902205|NCT00574587|FG002|Participant Flow|Stratum B: Triple Negative|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902206|NCT00574587|FG003|Participant Flow|Stratum C: ER-Positive, HER2-negative|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902207|NCT00574587|OG000|Outcome|Stratum A: VR-Paclitaxel-Trastuzumab|Stratum A: Vorinostat 200 (Dose Level 1) or 300 mg (Dose level 2) by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery
10902208|NCT00574587|OG001|Outcome|Stratum B: VR-Paclitaxel-Trastuzumab|Stratum B: 300 mg by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery
10902209|NCT00574587|OG000|Outcome|Stratum A (HER2-positive)|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 200-300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902210|NCT00574587|OG001|Outcome|Stratum B: Triple Negative|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902211|NCT00574587|OG002|Outcome|Stratum C: ER-Positive, HER2-negative|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902212|NCT00574587|EG000|Reported Event|Stratum A (HER2-positive): Dose Level 1|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 200 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902213|NCT00574587|EG001|Reported Event|Stratum A (HER2-positive): Dose Level 2|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902214|NCT00574587|EG002|Reported Event|Stratum B: Triple Negative|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902215|NCT00574587|EG003|Reported Event|Stratum C: ER-Positive, HER2-negative|"Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks and trastuzumab x 12 weeks, followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery~Vorinostat: Vorinostat 300 mg PO BID on days 1-3 of each weekly paclitaxel dose~Paclitaxel: Paclitaxel 80 mg/m2 weekly for 12 weeks~Trastuzumab: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose~Doxorubicin: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks~Cyclophosphamide: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks~Surgery: Surgical excision of tumor from breast"
10902216|NCT00574704|BG000|Baseline|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
10902217|NCT00574704|BG001|Baseline|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
10902218|NCT00574704|BG002|Baseline|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
10902219|NCT00574704|BG003|Baseline|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
11342283|NCT03704194|BG001|Baseline|Attention Control|"Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest."
10902220|NCT00574704|BG004|Baseline|Total|Total of all reporting groups
10902221|NCT00574704|FG000|Participant Flow|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
10902222|NCT00574704|FG001|Participant Flow|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
10902223|NCT00574704|FG002|Participant Flow|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
10902224|NCT00574704|FG003|Participant Flow|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
10902225|NCT00574704|OG000|Outcome|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
10902226|NCT00574704|OG001|Outcome|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
10902227|NCT00574704|OG002|Outcome|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
10902228|NCT00574704|OG003|Outcome|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
10902229|NCT00574704|EG000|Reported Event|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
10902230|NCT00574704|EG001|Reported Event|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
10902231|NCT00574704|EG002|Reported Event|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
10902232|NCT00574704|EG003|Reported Event|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
10902233|NCT00574795|BG000|Baseline|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
10902234|NCT00574795|FG000|Participant Flow|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
10902235|NCT00574795|OG000|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
11172034|NCT02006706|BG000|Baseline|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
11172035|NCT02006706|FG000|Participant Flow|Rituximab/Methylprednisolone/Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg), intravaneously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
11172036|NCT02006706|OG000|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
11172037|NCT02006706|EG000|Reported Event|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
11172038|NCT02006719|BG000|Baseline|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
11172039|NCT02006719|BG001|Baseline|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
11172040|NCT02006719|BG002|Baseline|Total|Total of all reporting groups
11172041|NCT02006719|FG000|Participant Flow|AA4500|Up to 3 injections of 0.58 mg/1 mL collagenase clostridium histolyticum (AA4500), minimum of 21 days apart and home shoulder exercise
11172042|NCT02006719|FG001|Participant Flow|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
11172043|NCT02006719|OG000|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
11172044|NCT02006719|OG001|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
11172045|NCT02006719|EG000|Reported Event|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
11172046|NCT02006719|EG001|Reported Event|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
11172047|NCT02006732|BG000|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
11172048|NCT02006732|BG001|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
11172049|NCT02006732|BG002|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11172050|NCT02006732|BG003|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11172051|NCT02006732|BG004|Baseline|Total|Total of all reporting groups
11172052|NCT02006732|FG000|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
11172053|NCT02006732|FG001|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
11172054|NCT02006732|FG002|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11172055|NCT02006732|FG003|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11172056|NCT02006732|OG000|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
11172057|NCT02006732|OG001|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
11172058|NCT02006732|OG002|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11172059|NCT02006732|OG003|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11172060|NCT02006732|EG000|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
11172061|NCT02006732|EG001|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
11172062|NCT02006732|EG002|Reported Event|Tiotropium 2.5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11172063|NCT02006732|EG003|Reported Event|Tiotropium 5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
11172064|NCT02006758|BG000|Baseline|Uncontrolled Hypertension Participants|Renal denervation procedure with the EnligHTN System for the treatment of uncontrolled hypertension
11172065|NCT02006758|FG000|Participant Flow|Uncontrolled Hypertension Participants|Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
11172066|NCT02006758|OG000|Outcome|Uncontrolled Hypertension Participants|Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
11172067|NCT02006758|OG000|Outcome|Uncontrolled Hypertension Patients|Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
11172068|NCT02006758|EG000|Reported Event|Uncontrolled Hypertension Participants|Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
11172069|NCT02006836|BG000|Baseline|Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
11172070|NCT02006836|BG001|Baseline|Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
11342284|NCT03704194|BG002|Baseline|Total|Total of all reporting groups
10902236|NCT00574795|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
10902237|NCT00574795|OG001|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
10902238|NCT00574795|OG002|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
10902239|NCT00574795|OG003|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
10902240|NCT00574795|OG000|Outcome|13vPnC Dose 1|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
10902241|NCT00574795|OG001|Outcome|13vPnC Dose 2|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
10902242|NCT00574795|OG002|Outcome|13vPnC Dose 3|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
10902243|NCT00574795|OG003|Outcome|13vPnC Toddler Dose|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
10902244|NCT00574795|OG000|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
10902245|NCT00574795|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
10902246|NCT00574795|EG001|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
10902247|NCT00574795|EG002|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).
10902248|NCT00574834|BG000|Baseline|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
10902249|NCT00574834|BG001|Baseline|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
10902250|NCT00574834|BG002|Baseline|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
10902251|NCT00574834|BG003|Baseline|Total|Total of all reporting groups
10902252|NCT00574834|FG000|Participant Flow|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
10902253|NCT00574834|FG001|Participant Flow|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
10902254|NCT00574834|FG002|Participant Flow|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
10902255|NCT00574834|OG000|Outcome|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
10902256|NCT00574834|OG001|Outcome|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
10902257|NCT00574834|OG002|Outcome|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
10902258|NCT00574834|EG000|Reported Event|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
10902259|NCT00574834|EG001|Reported Event|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
10902260|NCT00574834|EG002|Reported Event|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
10902261|NCT00574847|BG000|Baseline|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
10902262|NCT00574847|BG001|Baseline|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
10902263|NCT00574847|BG002|Baseline|Total|Total of all reporting groups
10902264|NCT00574847|FG000|Participant Flow|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
10902265|NCT00574847|FG001|Participant Flow|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
10902266|NCT00574847|OG000|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
10902267|NCT00574847|OG001|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
10902268|NCT00574847|EG000|Reported Event|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
10902269|NCT00574847|EG001|Reported Event|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
10902270|NCT00574873|BG000|Baseline|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
10902271|NCT00574873|BG001|Baseline|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
10902272|NCT00574873|BG002|Baseline|Total|Total of all reporting groups
10902273|NCT00574873|FG000|Participant Flow|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
10902274|NCT00574873|FG001|Participant Flow|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
10902275|NCT00574873|OG000|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
10902276|NCT00574873|OG001|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
10902277|NCT00574873|EG000|Reported Event|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
10902278|NCT00574873|EG001|Reported Event|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
10902279|NCT00574912|BG000|Baseline|1--All Interventions|"Arm: Other: 1--All interventions~All participant will be given all 5 interventions in the same order~Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
10902280|NCT00574912|FG000|Participant Flow|1 All Interventions|"Other: 1--All interventions~All participant will be given all 5 interventions in the same order~Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
10902281|NCT00574912|OG000|Outcome|Placebo|Maximum glucose infusion rate
10902282|NCT00574912|OG001|Outcome|0.5 Units of Glargine/kg|maximum glucose infusion rate
10902283|NCT00574912|OG002|Outcome|1.0 Units of Glargine/kg|maximum glucose infusion rate
10902284|NCT00574912|OG003|Outcome|1.5 Units of Glargine/kg|maximum glucose infusion rate
10902285|NCT00574912|OG004|Outcome|2.0 Units of Glargine/kg|maximum glucose infusion rate
10902286|NCT00574912|EG000|Reported Event|Placebo|"Placebo~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
10902287|NCT00574912|EG001|Reported Event|0.5 Units of Glargine/kg Body Weight|"0.5 units of Glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
10902288|NCT00574912|EG002|Reported Event|1 Unit of Glargine/kg Body Weight|"1 unit of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
10902289|NCT00574912|EG003|Reported Event|1.5 Units of Glargine/kg Body Weight|"1.5 units of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
10902290|NCT00574912|EG004|Reported Event|2.0 Units of Glargine/kg Body Weight|"2.0 units of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
10902291|NCT00574951|BG000|Baseline|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
10902292|NCT00574951|FG000|Participant Flow|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
10902293|NCT00574951|OG000|Outcome|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
10902294|NCT00574951|EG000|Reported Event|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
10902295|NCT00574990|BG000|Baseline|VA Physicians|VA physicians who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902296|NCT00574990|BG001|Baseline|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902297|NCT00574990|BG002|Baseline|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902298|NCT00574990|BG003|Baseline|Total|Total of all reporting groups
10902299|NCT00574990|FG000|Participant Flow|VA Physicians|VA Physicians who have spent at least one year in the VA and be familiar with the VA's electronic health record, CPRS.
10902300|NCT00574990|FG001|Participant Flow|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902301|NCT00574990|FG002|Participant Flow|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902302|NCT00574990|OG000|Outcome|Physicians|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902303|NCT00574990|OG001|Outcome|Nurses|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902304|NCT00574990|OG002|Outcome|Pharmacists|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902305|NCT00574990|OG000|Outcome|VA Physicians|VA providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902306|NCT00574990|OG001|Outcome|VA Nurses|VA nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902307|NCT00574990|OG002|Outcome|VA Pharmacists|VA pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
10902308|NCT00574990|EG000|Reported Event|VA Physicians|VA Physicians who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
10902309|NCT00574990|EG001|Reported Event|VA Nurses|VA Nurses who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
10902310|NCT00574990|EG002|Reported Event|VA Pharmacists|VA Pharmacists who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
10902311|NCT00575016|BG000|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10902312|NCT00575016|BG001|Baseline|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
10902313|NCT00575016|BG002|Baseline|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
10902314|NCT00575016|BG003|Baseline|Placebo|Normal saline (placebo)
10902315|NCT00575016|BG004|Baseline|Total|Total of all reporting groups
10902316|NCT00575016|FG000|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10902317|NCT00575016|FG001|Participant Flow|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
10902318|NCT00575016|FG002|Participant Flow|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
10902319|NCT00575016|FG003|Participant Flow|Placebo|Normal saline (placebo)
10902320|NCT00575016|OG000|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10902321|NCT00575016|OG001|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
10902322|NCT00575016|OG002|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
10902323|NCT00575016|OG003|Outcome|Placebo|Normal saline (placebo)
10902324|NCT00575016|EG000|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
10902325|NCT00575016|EG001|Reported Event|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
10902326|NCT00575016|EG002|Reported Event|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
10902327|NCT00575016|EG003|Reported Event|Placebo|Normal saline (placebo)
10902328|NCT00575029|BG000|Baseline|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
10902329|NCT00575029|FG000|Participant Flow|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
10902330|NCT00575029|OG000|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
11090931|NCT01532414|FG001|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11090932|NCT01532414|FG002|Participant Flow|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
11090933|NCT01532414|OG000|Outcome|Androxal Treated Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11090934|NCT01532414|OG000|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11090935|NCT01532414|OG001|Outcome|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
11090936|NCT01532414|EG000|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11090937|NCT01532414|EG001|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
11090938|NCT01532414|EG002|Reported Event|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
11090939|NCT01532453|BG000|Baseline|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
10902331|NCT00575029|EG000|Reported Event|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
10902332|NCT00575042|BG000|Baseline|Patients Treated With Fenofibrate|Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg per day
10902333|NCT00575042|FG000|Participant Flow|Fenofibrate 160 mg Per Day|Fenofibrate (Insoluble Drug Deliver-Micro Particle Fenofibrate (IDD-P)) 160 mg per day
10902334|NCT00575042|OG000|Outcome|Patients Before Treatment With Fenofibrate|Patients with previous incomplete response to UDCA
10902335|NCT00575042|OG001|Outcome|Patients Treated With Fenofibrate|Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
10902336|NCT00575042|EG000|Reported Event|Patients Treated With Fenofibrate|Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg per day
10902337|NCT00575094|BG000|Baseline|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
10902338|NCT00575094|FG000|Participant Flow|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
10902339|NCT00575094|OG000|Outcome|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
10902340|NCT00575094|EG000|Reported Event|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
10902341|NCT00575146|BG000|Baseline|Ketogenic Diet|ketogenic diet
10902342|NCT00575146|FG000|Participant Flow|Ketogenic Diet|unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin
10902343|NCT00575146|OG000|Outcome|Ketogenic Diet|unrestricted ketogenic diet
10902344|NCT00575146|EG000|Reported Event|Ketogenic Diet|ketogenic diet
10902345|NCT00575159|BG000|Baseline|Overall Study Arm|Participants received 5 treatments P0, P1, A, B, C in each of the treatment period in a randomized manner separated by a 5 to 35-day washout period between treatments, where Treatment P0 consisted of Basal insulin [continuous subcutaneous insulin injection (CSII)], mealtime placebo injection, and placebo tablet. Treatment P1 consisted of CSII, mealtime bolus insulin injection, and Placebo tablet. Treatment A consisted of CSII, mealtime placebo injection, GSK189075 50 mg tablet. Treatment B consisted of CSII, mealtime placebo injection, GSK189075 150 mg tablet. Treatment C consisted of CSII, mealtime placebo injection, GSK189075 500 mg tablet. The two placebo sessions (P0 and P1) were designed to provide information about the relative efficacy of GSK189075 versus each individual participant's usual mealtime insulin bolus. The number of tablets administered will be same for each treatment arm.
10902346|NCT00575159|FG000|Participant Flow|Overall Study Arm|Participants received 5 treatments P0, P1, A, B, C in each of the treatment period in a randomized manner separated by a 5 to 35-day washout period between treatments, where Treatment P0 consisted of Basal insulin [continuous subcutaneous insulin injection (CSII)], mealtime placebo injection, and placebo tablet. Treatment P1 consisted of CSII, mealtime bolus insulin injection, and Placebo tablet. Treatment A consisted of CSII, mealtime placebo injection, GSK189075 50 milligram (mg) tablet. Treatment B consisted of CSII, mealtime placebo injection, GSK189075 150 mg tablet. Treatment C consisted of CSII, mealtime placebo injection, GSK189075 500 mg tablet. The two placebo sessions (P0 and P1) were designed to provide information about the relative efficacy of GSK189075 versus each individual participant's usual mealtime insulin bolus. The number of tablets administered will be same for each treatment arm.
10902347|NCT00575159|OG000|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250 milliliter (mL) of water.
10902348|NCT00575159|OG001|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902349|NCT00575159|OG002|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902350|NCT00575159|OG003|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902351|NCT00575159|OG004|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902352|NCT00575159|OG000|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902353|NCT00575159|OG000|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902354|NCT00575159|OG001|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902355|NCT00575159|OG002|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902356|NCT00575159|EG000|Reported Event|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902357|NCT00575159|EG001|Reported Event|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902358|NCT00575159|EG002|Reported Event|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902359|NCT00575159|EG003|Reported Event|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902360|NCT00575159|EG004|Reported Event|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
10902361|NCT00575185|BG000|Baseline|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
10902362|NCT00575185|BG001|Baseline|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
10902363|NCT00575185|BG002|Baseline|Total|Total of all reporting groups
10902364|NCT00575185|FG000|Participant Flow|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
10902365|NCT00575185|FG001|Participant Flow|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
10902366|NCT00575185|OG000|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
10902367|NCT00575185|OG001|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
10902368|NCT00575185|OG000|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir: 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
10902369|NCT00575185|OG001|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days~placebo: Placebo tablets orally twice daily for 21 days."
11342285|NCT03704194|FG000|Participant Flow|Adapted LiFE|"Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar."
10902370|NCT00575185|EG000|Reported Event|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
10902371|NCT00575185|EG001|Reported Event|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
10902372|NCT00575328|BG000|Baseline|Maca Root|"Subjects in this arm will be given 3g/day of Maca Root.~Maca Root: 3g/day of Maca Root for 12 weeks."
10902373|NCT00575328|BG001|Baseline|Placebo|"Subjects in this arm will receive inactive placebo.~Placebo: Placebo provided by research pharmacy daily for 12 weeks."
10902374|NCT00575328|BG002|Baseline|Total|Total of all reporting groups
10902375|NCT00575328|FG000|Participant Flow|Maca Root|"Subjects in this arm will be given 3g/day of Maca Root.~Maca Root: 3g/day of Maca Root for 12 weeks."
10902376|NCT00575328|FG001|Participant Flow|Placebo|"Subjects in this arm will receive inactive placebo.~Placebo: Placebo provided by research pharmacy daily for 12 weeks."
10902377|NCT00575328|OG000|Outcome|Maca Root|"Subjects in this arm will be given 3g/day of Maca Root.~Maca Root: 3g/day of Maca Root for 12 weeks."
10902378|NCT00575328|OG001|Outcome|Placebo|"Subjects in this arm will receive inactive placebo.~Placebo: Placebo provided by research pharmacy daily for 12 weeks."
10902379|NCT00575328|EG000|Reported Event|Maca Root|"Subjects in this arm will be given 3g/day of Maca Root.~Maca Root: 3g/day of Maca Root for 12 weeks."
10902380|NCT00575328|EG001|Reported Event|Placebo|"Subjects in this arm will receive inactive placebo.~Placebo: Placebo provided by research pharmacy daily for 12 weeks."
10902381|NCT00575367|BG000|Baseline|AzaSite|
10902382|NCT00575367|BG001|Baseline|Vigamox|
10902383|NCT00575367|BG002|Baseline|Total|Total of all reporting groups
10902384|NCT00575367|FG000|Participant Flow|AzaSite|
10902385|NCT00575367|FG001|Participant Flow|Vigamox|
10902386|NCT00575367|OG000|Outcome|AzaSite|
10902387|NCT00575367|OG001|Outcome|Vigamox|
10902388|NCT00575367|EG000|Reported Event|AzaSite|
10902389|NCT00575367|EG001|Reported Event|Vigamox|
10902390|NCT00575380|BG000|Baseline|Azasite|
10902391|NCT00575380|BG001|Baseline|Vigamox|
10902392|NCT00575380|BG002|Baseline|Total|Total of all reporting groups
10902393|NCT00575380|FG000|Participant Flow|Azasite|
10902394|NCT00575380|FG001|Participant Flow|Vigamox|
10902395|NCT00575380|OG000|Outcome|Azasite|
10902396|NCT00575380|OG001|Outcome|Vigamox|
10902397|NCT00575380|EG000|Reported Event|Azasite|
10902398|NCT00575380|EG001|Reported Event|Vigamox|
10902399|NCT00575510|BG000|Baseline|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
10902400|NCT00575510|BG001|Baseline|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
10902401|NCT00575510|BG002|Baseline|Standard Care Only|Clinical standard of care at time of study
10902402|NCT00575510|BG003|Baseline|Total|Total of all reporting groups
10902403|NCT00575510|FG000|Participant Flow|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
10902404|NCT00575510|FG001|Participant Flow|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
10902405|NCT00575510|FG002|Participant Flow|Standard Care Only|Clinical standard of care at time of study
10902406|NCT00575510|OG000|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
10902407|NCT00575510|OG001|Outcome|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
10902408|NCT00575510|OG002|Outcome|Standard Care Only|Clinical standard of care at time of study
10902409|NCT00575510|OG001|Outcome|Active Control|"non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
10902410|NCT00575510|EG000|Reported Event|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
10902411|NCT00575510|EG001|Reported Event|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
10902412|NCT00575510|EG002|Reported Event|Standard Care Only|Clinical standard of care at time of study
10902413|NCT00575588|BG000|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
10902414|NCT00575588|BG001|Baseline|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
10902415|NCT00575588|BG002|Baseline|Total|Total of all reporting groups
10902416|NCT00575588|FG000|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
10902417|NCT00575588|FG001|Participant Flow|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
10902418|NCT00575588|OG000|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
10902419|NCT00575588|OG001|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
10902420|NCT00575588|EG000|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
10902421|NCT00575588|EG001|Reported Event|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
10902422|NCT00575666|BG000|Baseline|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
10902423|NCT00575666|BG001|Baseline|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
10902424|NCT00575666|BG002|Baseline|Total|Total of all reporting groups
10902425|NCT00575666|FG000|Participant Flow|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
10902426|NCT00575666|FG001|Participant Flow|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
10902427|NCT00575666|OG000|Outcome|Humulin|160 IU per day for 8 weeks
10902428|NCT00575666|OG001|Outcome|Placebo|160 IU per day for 8 weeks
10902429|NCT00575666|EG000|Reported Event|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
10902430|NCT00575666|EG001|Reported Event|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
10902431|NCT00575887|BG000|Baseline|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
10902432|NCT00575887|FG000|Participant Flow|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
10902433|NCT00575887|OG000|Outcome|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
10902434|NCT00575887|EG000|Reported Event|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
10902435|NCT00575965|BG000|Baseline|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
10902436|NCT00575965|FG000|Participant Flow|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
10902437|NCT00575965|OG000|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
10902438|NCT00575965|EG000|Reported Event|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
10902439|NCT00576056|BG000|Baseline|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
10902440|NCT00576056|FG000|Participant Flow|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
10902441|NCT00576056|OG000|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
10914951|NCT00633464|BG001|Baseline|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
10914952|NCT00633464|BG002|Baseline|Total|Total of all reporting groups
11090940|NCT01532453|BG001|Baseline|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
11090941|NCT01532453|BG002|Baseline|Total|Total of all reporting groups
11090942|NCT01532453|FG000|Participant Flow|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
11090943|NCT01532453|FG001|Participant Flow|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
11090944|NCT01532453|OG000|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
11090945|NCT01532453|OG001|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
11090946|NCT01532453|EG000|Reported Event|Standard Sun Protection Measures|"Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).~Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product."
11090947|NCT01532453|EG001|Reported Event|MD-3511356|"Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).~MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun."
11090948|NCT01532570|BG000|Baseline|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090949|NCT01532570|BG001|Baseline|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090950|NCT01532570|BG002|Baseline|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
10902442|NCT00576056|EG000|Reported Event|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
10902443|NCT00576147|BG000|Baseline|CT Scan|The standard head CT done to head trauma patients
10902444|NCT00576147|FG000|Participant Flow|CT Scan|The standard head CT done to head trauma patients
10902445|NCT00576147|OG000|Outcome|CT Scan|The standard head CT done to head trauma patients
10902446|NCT00576147|EG000|Reported Event|CT Scan|The standard head CT done to head trauma patients
10902447|NCT00576199|BG000|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
10902448|NCT00576199|FG000|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
10902449|NCT00576199|OG000|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
10902450|NCT00576199|EG000|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
10902451|NCT00576251|BG000|Baseline|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
11172071|NCT02006836|BG002|Baseline|Diabetic 2|For self-control period. The scheme and dose of Continuous Subcutaneous Insulin Infusion (CSII) for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.
11172072|NCT02006836|BG003|Baseline|Total|Total of all reporting groups
11172073|NCT02006836|FG000|Participant Flow|Case-Control: Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
10902452|NCT00576251|BG001|Baseline|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
10902453|NCT00576251|BG002|Baseline|Total|Total of all reporting groups
10902454|NCT00576251|FG000|Participant Flow|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
10902455|NCT00576251|FG001|Participant Flow|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
10902456|NCT00576251|OG000|Outcome|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
10902457|NCT00576251|OG001|Outcome|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
10902458|NCT00576251|EG000|Reported Event|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
10902459|NCT00576251|EG001|Reported Event|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
10902460|NCT00576303|BG000|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
10902461|NCT00576303|FG000|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the erythropoiesis stimulating agents (ESA) like epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
10902462|NCT00576303|OG000|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
10902463|NCT00576303|EG000|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
10902464|NCT00576316|BG000|Baseline|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
10902465|NCT00576316|FG000|Participant Flow|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
11172074|NCT02006836|FG001|Participant Flow|Case-Control: Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
11172075|NCT02006836|FG002|Participant Flow|Self-Control: Diabetic 2|"For self-control period. Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.~On the 4th to 6th day, patients with a constant dose of insulin did not consume Majia pomelos after meals, and this intervention was defined as blank.~On the 7th to 9th day, patients with the same dose of insulin consumed 100g Majia pomelos after meals (breakfast, lunch and dinner)."
10902466|NCT00576316|OG000|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
10902467|NCT00576316|EG000|Reported Event|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
10902468|NCT00576381|BG000|Baseline|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
10902469|NCT00576381|FG000|Participant Flow|Neonatal Dose Escalation Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.~Cohort 1--0.25 mcg/kg loading dose, 0.2 mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
10902470|NCT00576381|OG000|Outcome|Neonates|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Cohort 1--0.25mcg/kg loading dose, 0.2mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
10902471|NCT00576381|EG000|Reported Event|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
10902472|NCT00576420|BG000|Baseline|FS VH S/D 500 S-apr - 60 Seconds|FS VH S/D 500 s-apr, 60 - seconds polymerization time
10902473|NCT00576420|BG001|Baseline|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
10902474|NCT00576420|BG002|Baseline|Control Group|Manual compression with surgical gauze pads.
10902475|NCT00576420|BG003|Baseline|Total|Total of all reporting groups
10902476|NCT00576420|FG000|Participant Flow|FS VH S/D 500 S-apr - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time
10902477|NCT00576420|FG001|Participant Flow|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
10902478|NCT00576420|FG002|Participant Flow|Control Group|Manual compression with surgical gauze pads.
10902479|NCT00576420|OG000|Outcome|FS VH S/D 500 S-apr- 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
10902480|NCT00576420|OG001|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
10902481|NCT00576420|OG002|Outcome|Control Group|Manual compression with surgical gauze pads.
10902482|NCT00576420|OG000|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
10902483|NCT00576420|OG000|Outcome|FS VH S/D 500 S-apr - 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
10902484|NCT00576420|OG001|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization.
10902485|NCT00576420|OG000|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-Seconds polymerization time
10902486|NCT00576420|OG002|Outcome|FS VH S/D 500 S-apr - All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902487|NCT00576420|OG003|Outcome|Control Group|Manual compression with surgical gauze pads
10902488|NCT00576420|OG002|Outcome|FS VH S/D 500 S-apr All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902489|NCT00576420|OG000|Outcome|FS VH S/D 500 S -Apr - 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization (FS 60)
10902490|NCT00576420|OG001|Outcome|FS VH S/D 500 S -Apr - 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization (FS 120)
10902491|NCT00576420|OG002|Outcome|FS VH S/D 500 S-apr - All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time) (FS All):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902492|NCT00576420|OG003|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
10902493|NCT00576420|OG000|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr (FS), 60-seconds polymerization
10902494|NCT00576420|OG001|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
10902495|NCT00576420|OG002|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902496|NCT00576420|OG003|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
10902497|NCT00576420|OG004|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
10902498|NCT00576420|OG005|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
10902499|NCT00576420|OG006|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902500|NCT00576420|OG007|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
10902501|NCT00576420|OG008|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
10902502|NCT00576420|OG009|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
10902503|NCT00576420|OG010|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902504|NCT00576420|OG011|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
10902505|NCT00576420|OG000|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
10902506|NCT00576420|OG001|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
10902507|NCT00576420|OG002|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902508|NCT00576420|OG000|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 60-seconds polymerization
10902509|NCT00576420|OG000|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
10902510|NCT00576420|OG001|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
10902511|NCT00576420|OG002|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902512|NCT00576420|OG003|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
10902513|NCT00576420|OG004|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
10902514|NCT00576420|OG005|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
10902515|NCT00576420|OG006|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902516|NCT00576420|OG007|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
10902517|NCT00576420|OG002|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902518|NCT00576420|OG004|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
10902519|NCT00576420|OG005|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
10902520|NCT00576420|OG006|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
10902521|NCT00576420|OG007|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
10902522|NCT00576420|EG000|Reported Event|Fibrin Sealant - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time
10902523|NCT00576420|EG001|Reported Event|Fibrin Sealant - 120 Seconds|FS VH S/D 500 s-apr, 120 seconds polymerization time
10902524|NCT00576420|EG002|Reported Event|Fibrin Sealant All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time~FS VH S/D 500 s-apr, 120 seconds polymerization time"
10902525|NCT00576420|EG003|Reported Event|Control Group|Treatment of the study-suture line will be manual compression with surgical gauze pads.
10914953|NCT00633464|FG000|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
10914954|NCT00633464|FG001|Participant Flow|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
10914955|NCT00633464|OG000|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
10914956|NCT00633464|OG001|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
10914957|NCT00633464|EG000|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
10914958|NCT00633464|EG001|Reported Event|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
10914959|NCT00633477|BG000|Baseline|Resatorvid 2.4 mg/kg/Day|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours
10914960|NCT00633477|BG001|Baseline|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
10914961|NCT00633477|BG002|Baseline|Total|Total of all reporting groups
10914962|NCT00633477|FG000|Participant Flow|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
10914963|NCT00633477|FG001|Participant Flow|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
10914964|NCT00633477|OG000|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
10914965|NCT00633477|OG001|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
10914966|NCT00633477|EG000|Reported Event|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
10902526|NCT00576472|BG000|Baseline|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
10902527|NCT00576472|BG001|Baseline|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
10902528|NCT00576472|BG002|Baseline|High|Intensity of prior Central Nervous System radiation therapy was considered high.
10902529|NCT00576472|BG003|Baseline|Not Randomized-In Lab Phase|Patients not randomized for the MPH in Lab Phase
10902530|NCT00576472|BG004|Baseline|Group M/P|Group M/P (patients receive oral Methylphenidate (MPH) and then an oral placebo)
10902531|NCT00576472|BG005|Baseline|Group P/M|Group P/M (patients receive oral placebo and ten Methylphenidate (MPH))
10902532|NCT00576472|BG006|Baseline|Not Randomized-Cross Over|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross Over Phase
10902533|NCT00576472|BG007|Baseline|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
10902534|NCT00576472|BG008|Baseline|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a lose dose of Methylphenidate (MPH) on week three.
10902535|NCT00576472|BG009|Baseline|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
10902536|NCT00576472|BG010|Baseline|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
10902537|NCT00576472|BG011|Baseline|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
10902538|NCT00576472|BG012|Baseline|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
10902539|NCT00576472|BG013|Baseline|Declined Home Maintenance Phase|Patients who completed the MPH Cross Over Phase but chose to decline participation in the Home Maintenance Phase.
10902540|NCT00576472|BG014|Baseline|Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the duration of the Home Maintenance Phase.
10902541|NCT00576472|BG015|Baseline|Total|Total of all reporting groups
10902542|NCT00576472|FG000|Participant Flow|Mild Intensity|Intensity of prior CNS Therapy (systemic and/or intrathecal chemotherapy only)classified as mild.
10902543|NCT00576472|FG001|Participant Flow|Moderate Intensity|Intensity of prior CNS Therapy (< 24 Gy CRT with or without systemic and/or intrathecal chemotherapy)classified as moderate.
10902544|NCT00576472|FG002|Participant Flow|High Intensity|Intensity of prior CNS Therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy) classified as high.
10902545|NCT00576472|FG003|Participant Flow|Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase.
10902546|NCT00576472|FG004|Participant Flow|Group M/P|Group M/P (patients received oral Methylphenidate (MPH) and then an oral placebo)
10902547|NCT00576472|FG005|Participant Flow|Group P/M|Group P/M (patients received oral placebo and then Methylphenidate (MPH))
10902548|NCT00576472|FG006|Participant Flow|Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross-Over Phase
10902549|NCT00576472|FG007|Participant Flow|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
10902550|NCT00576472|FG008|Participant Flow|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a low dose of Methylphenidate (MPH) on week three.
10902551|NCT00576472|FG009|Participant Flow|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
11357164|NCT03763929|BG001|Baseline|Placebo|"The placebo consists of commercially available sterile saline. Placebo will be administered intravenously as a bolus to subjects randomized to placebo. The volume of sterile saline will be based on the estimated subject weight.~Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance."
10902552|NCT00576472|FG010|Participant Flow|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
10902553|NCT00576472|FG011|Participant Flow|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
10902554|NCT00576472|FG012|Participant Flow|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
10902555|NCT00576472|FG013|Participant Flow|Declined Methylphenidate (MPH) Home Maintenance Phase|Patients who completed the Methylphenidate (MPH) Cross Over Phase but chose to decline participation in the Methylphenidate (MPH) Home Maintenance Phase.
10902556|NCT00576472|FG014|Participant Flow|Methylphenidate (MPH) Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the Methylphenidate (MPH) Home Maintenance Phase.
10902557|NCT00576472|OG000|Outcome|Patients|Patients with evaluable MRIs.
10902558|NCT00576472|OG001|Outcome|Siblings|Sibling controls with evaluable MRIs.
10902559|NCT00576472|OG000|Outcome|Patients With ALL|Patients with Acute Lymphoblastic Leukemia (ALL) who had evaluable MRIs.
10902560|NCT00576472|OG001|Outcome|Patients With Brain Tumors|Patients with brain tumors who had evaluable MRIs.
10902561|NCT00576472|OG000|Outcome|Siblings|The sibling control group received no radiation therapy.
10902562|NCT00576472|OG001|Outcome|Mild Treatment Intensity|Mildly intense central nervous system therapy (systemic and/or intrathecal chemotherapy only)
10902563|NCT00576472|OG002|Outcome|Moderate Treatment Intensity|Moderately intense central nervous system therapy (<= 24 Gy CRT with or without systemic and/or intrathecal chemotherapy).
10902564|NCT00576472|OG003|Outcome|High Treatment Intensity|High intensity central nervous system therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy.
10902565|NCT00576472|OG000|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
10902566|NCT00576472|OG000|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: Cognitive Problem T Score Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
10902567|NCT00576472|OG000|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
10902568|NCT00576472|OG000|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
10902569|NCT00576472|OG000|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
10902570|NCT00576472|OG000|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Reading: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
10902571|NCT00576472|OG000|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Spelling: Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
10902572|NCT00576472|OG000|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Math: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
10902573|NCT00576472|OG000|Outcome|Placebo|Patients assigned to the placebo group were randomly assigned to receive one of two arms: Group PLM received placebo during week one, low dose during week 2, and moderate dose during week 3; Group PML received placebo during week one, moderate dose during week 2, and low dose during week 3.
10902574|NCT00576472|OG001|Outcome|Low Dose|Patients assigned to the Low Dose group were randomly assigned to receive one of two arms: Group LMP received low dose during week one, moderate dose during week 2, and placebo during week 3; Group LPM received low dose during week one, placebo during week 2, and moderate dose during week 3.
10902575|NCT00576472|OG002|Outcome|Moderate Dose|Patients assigned to the Moderate Dose group were randomly assigned to receive one of two arms: Group MLP received moderate dose during week one, low dose during week 2, and placebo during week 3; Group MPL received moderate dose during week one, placebo during week 2, and low dose during week 3.
10902576|NCT00576472|OG000|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
10902577|NCT00576472|OG001|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
10902578|NCT00576472|OG002|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
10902579|NCT00576472|OG002|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
10914967|NCT00633477|EG001|Reported Event|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
11090951|NCT01532570|BG003|Baseline|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
10902580|NCT00576472|OG000|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
10902581|NCT00576472|OG001|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
10902582|NCT00576472|OG002|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
10902583|NCT00576472|EG000|Reported Event|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
10902584|NCT00576472|EG001|Reported Event|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
10902585|NCT00576472|EG002|Reported Event|High|Intensity of prior Central Nervous System radiation therapy was considered high.
10902586|NCT00576576|BG000|Baseline|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
10902587|NCT00576576|FG000|Participant Flow|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
10902588|NCT00576576|OG000|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
10902589|NCT00576576|EG000|Reported Event|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
10902590|NCT00576628|BG000|Baseline|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
10902591|NCT00576628|FG000|Participant Flow|C.E.R.A|Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
10902592|NCT00576628|OG000|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
10902593|NCT00576628|OG000|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range..
10902594|NCT00576628|EG000|Reported Event|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
10902595|NCT00576680|BG000|Baseline|Temozolomide and Everolimus|Temozolomide was administered to all patients at a starting dose of 150 mg/m2 on days 1 to 7 and days 15 to 21 of a 28-day cycle. Everolimus was administered together with temozolomide in 2 dose cohorts: 1) 5 mg daily and 2) 10 mg daily.
10902596|NCT00576680|FG000|Participant Flow|Temozolomide and Everolimus|Temozolomide was administered to all patients at a starting dose of 150 mg/m2 on days 1 to 7 and days 15 to 21 of a 28-day cycle. Everolimus was administered together with temozolomide in 2 dose cohorts: 1) 5 mg daily and 2) 10 mg daily.
10902597|NCT00576680|OG000|Outcome|Temozolomide and Everolimus|Temozolomide was administered to all patients at a starting dose of 150 mg/m2 on days 1 to 7 and days 15 to 21 of a 28-day cycle. Everolimus was administered together with temozolomide in 2 dose cohorts: 1) 5 mg daily and 2) 10 mg daily.
10902598|NCT00576680|EG000|Reported Event|Temozolomide and Everolimus|Temozolomide was administered to all patients at a starting dose of 150 mg/m2 on days 1 to 7 and days 15 to 21 of a 28-day cycle. Everolimus was administered together with temozolomide in 2 dose cohorts: 1) 5 mg daily and 2) 10 mg daily.
10902599|NCT00576693|BG000|Baseline|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
11090952|NCT01532570|BG004|Baseline|Total|Total of all reporting groups
10902600|NCT00576693|BG001|Baseline|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
10902601|NCT00576693|BG002|Baseline|Total|Total of all reporting groups
10902602|NCT00576693|FG000|Participant Flow|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
10902603|NCT00576693|FG001|Participant Flow|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
10902604|NCT00576693|OG000|Outcome|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
10902605|NCT00576693|OG001|Outcome|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
10902606|NCT00576693|EG000|Reported Event|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
10902607|NCT00576693|EG001|Reported Event|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
10902608|NCT00576732|BG000|Baseline|Placebo|Double-blind Period. Oral solution for 6 weeks.
10902609|NCT00576732|BG001|Baseline|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
10902610|NCT00576732|BG002|Baseline|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
10902611|NCT00576732|BG003|Baseline|Total|Total of all reporting groups
10902612|NCT00576732|FG000|Participant Flow|Placebo|Double-blind Period. Oral solution for 6 weeks.
10902613|NCT00576732|FG001|Participant Flow|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
10902614|NCT00576732|FG002|Participant Flow|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
11090953|NCT01532570|FG000|Participant Flow|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
10902615|NCT00576732|FG003|Participant Flow|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
10902616|NCT00576732|FG004|Participant Flow|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
10902617|NCT00576732|FG005|Participant Flow|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
10902618|NCT00576732|OG000|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
10902619|NCT00576732|OG001|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
10902620|NCT00576732|OG002|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
10902621|NCT00576732|OG000|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
10902622|NCT00576732|OG001|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
10902623|NCT00576732|OG002|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
10902624|NCT00576732|EG000|Reported Event|Placebo|Double-blind Period. Oral solution for 6 weeks.
10902625|NCT00576732|EG001|Reported Event|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
10902626|NCT00576732|EG002|Reported Event|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
10902627|NCT00576732|EG003|Reported Event|Open-label Risperidone|Subjects who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
10902628|NCT00576758|BG000|Baseline|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
10902629|NCT00576758|BG001|Baseline|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
10902630|NCT00576758|BG002|Baseline|Total|Total of all reporting groups
10902631|NCT00576758|FG000|Participant Flow|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
11342286|NCT03704194|FG001|Participant Flow|Attention Control|"Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest."
10902632|NCT00576758|FG001|Participant Flow|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
10902633|NCT00576758|OG000|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
11172076|NCT02006836|OG000|Outcome|Diabetic|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
11172077|NCT02006836|OG001|Outcome|Healthy|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
11357165|NCT03763929|BG002|Baseline|Total|Total of all reporting groups
11090954|NCT01532570|FG001|Participant Flow|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090955|NCT01532570|FG002|Participant Flow|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090956|NCT01532570|FG003|Participant Flow|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090957|NCT01532570|OG000|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090958|NCT01532570|OG001|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090959|NCT01532570|OG002|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090960|NCT01532570|OG003|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090961|NCT01532570|OG001|Outcome|Neuro-BD (Acute+Chronic Progressive)|"Acute; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.~Chronic Progressive; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30."
11090962|NCT01532570|OG002|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090963|NCT01532570|OG000|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090964|NCT01532570|OG000|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090965|NCT01532570|OG000|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090966|NCT01532570|OG000|Outcome|Acute Neuro BD (Patient 1)|
11090967|NCT01532570|OG001|Outcome|Acute Neuro-BD (Patient 2)|
11090968|NCT01532570|OG000|Outcome|Acute Neuro BD (Patient No.1)|
11090969|NCT01532570|OG001|Outcome|Acute Neuro-BD (Patient No.2)|
11090970|NCT01532570|OG002|Outcome|Chronic Progressive Neuro-BD|
11090971|NCT01532570|EG000|Reported Event|TA-650|TA-650: TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
11090972|NCT01532648|BG000|Baseline|Budesonide MMX|Participants received 1 oral tablet of budesonide MMX 9 mg for 56 days. Additionally, participants continued to receive the same dose of their existing oral 5-ASA medication from their treating physician.
11090973|NCT01532648|BG001|Baseline|Placebo|Participants received 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants continued to receive the same dose of their existing oral 5-ASA medication from their treating physician.
11090974|NCT01532648|BG002|Baseline|Total|Total of all reporting groups
11090975|NCT01532648|FG000|Participant Flow|Budesonide MMX|Participants received 1 oral tablet of budesonide multi-matrix system (MMX) 9 milligrams (mg) for 56 days. Additionally, participants continued to receive the same dose of their existing oral 5-aminosalicylic acid (5-ASA) medication from their treating physician.
11090976|NCT01532648|FG001|Participant Flow|Placebo|Participants received 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants continued to receive the same dose of their existing oral 5-ASA medication from their treating physician.
11090977|NCT01532648|OG000|Outcome|Budesonide MMX|Participants received 1 oral tablet of budesonide MMX 9 mg for 56 days. Additionally, participants continued to receive the same dose of their existing oral 5-ASA medication from their treating physician.
11090978|NCT01532648|OG001|Outcome|Placebo|Participants received 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants continued to receive the same dose of their existing oral 5-ASA medication from their treating physician.
11090979|NCT01532648|EG000|Reported Event|Budesonide MMX|Participants received 1 oral tablet of budesonide MMX 9 mg for 56 days. Additionally, participants continued to receive the same dose of their existing oral 5-ASA medication from their treating physician.
11090980|NCT01532648|EG001|Reported Event|Placebo|Participants received 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants continued to receive the same dose of their existing oral 5-ASA medication from their treating physician.
11090981|NCT01532687|BG000|Baseline|Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gemcitabine: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib: Given PO~Pazopanib Hydrochloride: Given PO"
10902634|NCT00576758|OG001|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
10902635|NCT00576758|OG000|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
10902636|NCT00576758|EG000|Reported Event|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
10902637|NCT00576758|EG001|Reported Event|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
10902638|NCT00576823|BG000|Baseline|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
10902639|NCT00576823|BG001|Baseline|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
10902640|NCT00576823|BG002|Baseline|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
10902641|NCT00576823|BG003|Baseline|Total|Total of all reporting groups
10902642|NCT00576823|FG000|Participant Flow|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
10902643|NCT00576823|FG001|Participant Flow|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
10902644|NCT00576823|FG002|Participant Flow|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
10902645|NCT00576823|OG000|Outcome|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
10902646|NCT00576823|OG001|Outcome|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
10902647|NCT00576823|OG002|Outcome|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
10902648|NCT00576823|OG000|Outcome|Alfuzosin Solution - 2-7 Years|
10902649|NCT00576823|OG001|Outcome|Alfuzosin Solution - 8-16 Years|
10902650|NCT00576823|OG002|Outcome|Alfuzosin Tablet - 8-16 Years|
10902651|NCT00576823|EG000|Reported Event|Afluzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
11342287|NCT03704194|OG000|Outcome|Adapted LiFE|"Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar."
10902652|NCT00576823|EG001|Reported Event|Afluzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
10902653|NCT00576823|EG002|Reported Event|Afluzosin Tablets - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
10902654|NCT00576901|BG000|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
10902655|NCT00576901|FG000|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1; docetaxel 75 mg per square meter (mg/m^2), IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
10902656|NCT00576901|OG000|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
10902657|NCT00576901|EG000|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
10902658|NCT00576927|BG000|Baseline|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
10902659|NCT00576927|BG001|Baseline|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
10902660|NCT00576927|BG002|Baseline|Total|Total of all reporting groups
10902661|NCT00576927|FG000|Participant Flow|All Subjects|
10902662|NCT00576927|OG000|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
10902663|NCT00576927|OG001|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
10902664|NCT00576927|EG000|Reported Event|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
10902665|NCT00576927|EG001|Reported Event|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
10902666|NCT00577005|BG000|Baseline|Levetiracetam|"Levetiracetam tablets~levetiracetam: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period."
10902667|NCT00577005|BG001|Baseline|Placebo|"matching placebo~Placebo"
10902668|NCT00577005|BG002|Baseline|Total|Total of all reporting groups
10902669|NCT00577005|FG000|Participant Flow|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
10902670|NCT00577005|FG001|Participant Flow|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
10902671|NCT00577005|OG000|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
10902672|NCT00577005|OG001|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
10902673|NCT00577005|OG000|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks~."
10902674|NCT00577005|OG000|Outcome|Levetiracetam|"Levetiracetam tablets~levetiracetam: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period."
10902675|NCT00577005|OG001|Outcome|Placebo|"matching placebo~Placebo"
10902676|NCT00577005|EG000|Reported Event|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
10902677|NCT00577005|EG001|Reported Event|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
10902678|NCT00577031|BG000|Baseline|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
10902679|NCT00577031|FG000|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
10902680|NCT00577031|OG000|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
10902681|NCT00577031|OG000|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
10902682|NCT00577031|OG000|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles):~Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day~1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):~If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
10902683|NCT00577031|OG000|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
10902684|NCT00577031|EG000|Reported Event|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
10902685|NCT00577083|BG000|Baseline|No Cap First, Then Cap Fitted|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
10902686|NCT00577083|BG001|Baseline|Initial Cap-fitted First Then No Cap|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
10902687|NCT00577083|BG002|Baseline|Total|Total of all reporting groups
11172078|NCT02006836|OG000|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
11342288|NCT03704194|OG001|Outcome|Attention Control|"Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest."
10902688|NCT00577083|FG000|Participant Flow|No Cap First, Then Cap-fitted|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
10902689|NCT00577083|FG001|Participant Flow|Initial Cap-fitted First, Then No Cap|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
10902690|NCT00577083|OG000|Outcome|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
10902691|NCT00577083|OG001|Outcome|Initial Regular|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
10902692|NCT00577083|OG000|Outcome|Insertion Inspection Times (Standard)|Standard Colonscopy
10902693|NCT00577083|OG001|Outcome|Insertion Inspection Times (Cap-Fitted)|Cap-Fitted
10902694|NCT00577083|OG002|Outcome|Inspection Times (Standard)|Standard
10902695|NCT00577083|OG003|Outcome|Inspection Times (Cap-Fitted)|Cap-fitted
10902696|NCT00577083|OG004|Outcome|Total Procedure Time (Cap-Fitted)|cap-fitted
10902697|NCT00577083|OG005|Outcome|Total Procedure Time (Standard)|standard
10902698|NCT00577083|EG000|Reported Event|Initial Regular|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
10902699|NCT00577083|EG001|Reported Event|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
10902700|NCT00577096|BG000|Baseline|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
10902701|NCT00577096|BG001|Baseline|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
10902702|NCT00577096|BG002|Baseline|Total|Total of all reporting groups
10902703|NCT00577096|FG000|Participant Flow|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
10902704|NCT00577096|FG001|Participant Flow|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
10902705|NCT00577096|OG000|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
10914968|NCT00633594|BG000|Baseline|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. .
10914969|NCT00633594|BG001|Baseline|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
11342289|NCT03704194|OG000|Outcome|Attention Control|"Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest."
10902706|NCT00577096|OG001|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
10902707|NCT00577096|EG000|Reported Event|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
10902708|NCT00577096|EG001|Reported Event|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
10902709|NCT00577122|BG000|Baseline|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
10902710|NCT00577122|BG001|Baseline|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
10902711|NCT00577122|BG002|Baseline|Total|Total of all reporting groups
10902712|NCT00577122|FG000|Participant Flow|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
10902713|NCT00577122|FG001|Participant Flow|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
10902714|NCT00577122|OG000|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
10902715|NCT00577122|OG001|Outcome|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
10902716|NCT00577122|OG001|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
10902717|NCT00577122|EG000|Reported Event|Cohort 1: MPA Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
10902718|NCT00577122|EG001|Reported Event|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
10902719|NCT00577135|BG000|Baseline|Q12 Hours Bolus & Low Intensification|
10902720|NCT00577135|BG001|Baseline|Q12 Hours Bolus & High Intensification|
10902721|NCT00577135|BG002|Baseline|Continuous Infusion & Low Intensification|
11335637|NCT03554018|FG001|Participant Flow|Placebo|"Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.~Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)~Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours"
10902722|NCT00577135|BG003|Baseline|Continuous Infusion & High Intensification|
10902723|NCT00577135|BG004|Baseline|Total|Total of all reporting groups
10902724|NCT00577135|FG000|Participant Flow|Q12 Hours Bolus & Low Intensification|Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus
10902725|NCT00577135|FG001|Participant Flow|Q12 Hours Bolus & High Intensification|High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus
10902726|NCT00577135|FG002|Participant Flow|Continuous Infusion & Low Intensification|Low intensification (1 x oral dose) IV furosemide by continuous infusion
10902727|NCT00577135|FG003|Participant Flow|Continuous Infusion & High Intensification|High intensification (2.5 x oral dose) IV furosemide by continuous infusion
10902728|NCT00577135|OG000|Outcome|Q 12 Hour Bolus|
10902729|NCT00577135|OG001|Outcome|Continuous Infusion|
10902730|NCT00577135|OG002|Outcome|Low Intensification|
10902731|NCT00577135|OG003|Outcome|High Intensification|
10902732|NCT00577135|EG000|Reported Event|Q 12 Hour Bolus|
10902733|NCT00577135|EG001|Reported Event|Continuous Infusion|
10902734|NCT00577135|EG002|Reported Event|Low Intensification|
10902735|NCT00577135|EG003|Reported Event|High Intensification|
10902736|NCT00577382|BG000|Baseline|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
10902737|NCT00577382|BG001|Baseline|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
10902738|NCT00577382|BG002|Baseline|Total|Total of all reporting groups
10902739|NCT00577382|FG000|Participant Flow|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
10902740|NCT00577382|FG001|Participant Flow|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
10902741|NCT00577382|OG000|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
11357455|NCT03757234|BG003|Baseline|Omadacycline 200 iv/450 po or 100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
10902742|NCT00577382|OG001|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
10902743|NCT00577382|EG000|Reported Event|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
10902744|NCT00577382|EG001|Reported Event|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
10902745|NCT00577408|BG000|Baseline|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
10902746|NCT00577408|BG001|Baseline|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).~Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
10902747|NCT00577408|BG002|Baseline|Total|Total of all reporting groups
10902748|NCT00577408|FG000|Participant Flow|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
10902749|NCT00577408|FG001|Participant Flow|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).~Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
10902750|NCT00577408|OG000|Outcome|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
10902751|NCT00577408|OG001|Outcome|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).~Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
10902752|NCT00577408|EG000|Reported Event|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
10902753|NCT00577408|EG001|Reported Event|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).~Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
10902754|NCT00577460|BG000|Baseline|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
10902755|NCT00577460|BG001|Baseline|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
10902756|NCT00577460|BG002|Baseline|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
10902757|NCT00577460|BG003|Baseline|Total|Total of all reporting groups
10902758|NCT00577460|FG000|Participant Flow|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
10902759|NCT00577460|FG001|Participant Flow|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
11172079|NCT02006836|OG001|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
10902760|NCT00577460|FG002|Participant Flow|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole Immediate Release (IR) in previous trial
10902761|NCT00577460|OG000|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
10902762|NCT00577460|OG001|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
10902763|NCT00577460|OG000|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
10902764|NCT00577460|OG001|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
10902765|NCT00577460|OG002|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
10902766|NCT00577460|OG003|Outcome|Total PPX ER|Pramipexole ER, all patients
10902767|NCT00577460|OG000|Outcome|Placebo|Treatment with matching placebo in previous trial (NCT00466167)
10902768|NCT00577460|OG001|Outcome|PPX ER|Treatment with Pramipexole ER in previous trial
10902769|NCT00577460|OG002|Outcome|PPX IR|Treatment with Pramipexole IR in previous trial
10902770|NCT00577460|EG000|Reported Event|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
10902771|NCT00577460|EG001|Reported Event|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
10902772|NCT00577460|EG002|Reported Event|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
10902773|NCT00577460|EG003|Reported Event|Total PPX ER|Pramipexole ER, all patients
10902774|NCT00577473|BG000|Baseline|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
10902775|NCT00577473|BG001|Baseline|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
10902776|NCT00577473|BG002|Baseline|Total|Total of all reporting groups
10902777|NCT00577473|FG000|Participant Flow|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
10902778|NCT00577473|FG001|Participant Flow|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
10902779|NCT00577473|OG000|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
10902780|NCT00577473|OG001|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
10902781|NCT00577473|EG000|Reported Event|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
10902782|NCT00577473|EG001|Reported Event|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
10902783|NCT00577512|BG000|Baseline|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
10902784|NCT00577512|FG000|Participant Flow|HD DTPACE|"High dose DTPACE (dexamethasone 200 mg days 1-7; thalidomide 200 mg days 1-4; cisplatin 15 mg/m2 days 1-4; adriamycin 15 mg/m2 days 1-4; cyclophosphamide 600 mg/m2 days 1-4; etoposide 60 mg/m2 days 1-4) and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion repeated every 18-21 days for 4 cycles~Bortezomib (1.0 mg/m2 Day 1, 4, 8, 11), thalidomide (100 mg/m2 days 1-21), and dexamethasone (20 mg days 1-4 and 9-12) (VTD) Maintenance therapy"
10902785|NCT00577512|OG000|Outcome|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
10902786|NCT00577512|EG000|Reported Event|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
10902787|NCT00577590|BG000|Baseline|Metformin and Lovaza|"Participants assigned to take metformin and Lovaza~Lovaza: Dosage of 4 g to be taken daily for 2 months~Metformin: Dosage of at least 1000 mg to be taken daily for 4 months"
10902788|NCT00577590|BG001|Baseline|Metformin|"Participants assigned to take metformin and placebo~Metformin: Dosage of at least 1000 mg to be taken daily for 4 months"
10902789|NCT00577590|BG002|Baseline|Metformin and Rosiglitizone|Participants assigned to take Metformin and Rosiglitizone
10902790|NCT00577590|BG003|Baseline|Total|Total of all reporting groups
10902791|NCT00577590|FG000|Participant Flow|Metformin and Lovaza|"Participants assigned to take metformin and Lovaza~Lovaza: Dosage of 4 g to be taken daily for 2 months~Metformin: Dosage of at least 1000 mg to be taken daily for 4 months"
10902792|NCT00577590|FG001|Participant Flow|Metformin|"Participants assigned to take metformin and placebo~Metformin: Dosage of at least 1000 mg to be taken daily for 4 months"
10902793|NCT00577590|FG002|Participant Flow|Metformin and Rosiglitazone|Patients received Metformin and Rosiglitizone
11090982|NCT01532687|BG001|Baseline|Gemcitabine Hydrochloride Plus Placebo|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gemcitabine: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib: Given PO~Pazopanib Hydrochloride: Given PO~Placebo Administration: Given PO"
11090983|NCT01532687|BG002|Baseline|Total|Total of all reporting groups
11090984|NCT01532687|FG000|Participant Flow|Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gemcitabine: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib: Given PO~Pazopanib Hydrochloride: Given PO"
10902794|NCT00577590|OG000|Outcome|Metformin and Lovaza|"Participants assigned to take metformin and Lovaza~Lovaza: Dosage of 4 g to be taken daily for 2 months~Metformin: Dosage of at least 1000 mg to be taken daily for 4 months"
10902795|NCT00577590|OG001|Outcome|Metformin|"Participants assigned to take metformin and placebo~Metformin: Dosage of at least 1000 mg to be taken daily for 4 months"
10902796|NCT00577590|OG002|Outcome|Metformin and Rosiglitazone|Patients received Metformin and Rosiglitizone
10902797|NCT00577590|EG000|Reported Event|Metformin and Lovaza|"Participants assigned to take metformin and Lovaza~Lovaza: Dosage of 4 g to be taken daily for 2 months~Metformin: Dosage of at least 1000 mg to be taken daily for 4 months"
10902798|NCT00577590|EG001|Reported Event|Metformin|"Participants assigned to take metformin and placebo~Metformin: Dosage of at least 1000 mg to be taken daily for 4 months"
10902799|NCT00577590|EG002|Reported Event|Metformin and Rosiglitizone|Participants assigned to take Metformin and Rosiglitizone
10902800|NCT00577629|BG000|Baseline|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
10902801|NCT00577629|FG000|Participant Flow|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
10902802|NCT00577629|OG000|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
10902803|NCT00577629|OG000|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
10902804|NCT00577629|OG000|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar)
10902805|NCT00577629|EG000|Reported Event|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
10902806|NCT00577642|BG000|Baseline|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period
10902807|NCT00577642|FG000|Participant Flow|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period.
10902808|NCT00577642|OG000|Outcome|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) treatment cessation during study period.
10902809|NCT00577642|EG000|Reported Event|Single Arm Study|This was a nonintervention biomarker study after a single dose of Zoledronic acid.
10902810|NCT00577655|BG000|Baseline|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
10902811|NCT00577655|BG001|Baseline|Placebo|Placebo HFA-MDI four times a day for 21 days.
10902812|NCT00577655|BG002|Baseline|Total|Total of all reporting groups
10902813|NCT00577655|FG000|Participant Flow|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
10902814|NCT00577655|FG001|Participant Flow|Placebo|Placebo HFA-MDI four times a day for 21 days.
10902815|NCT00577655|OG000|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
10902816|NCT00577655|OG001|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
10902817|NCT00577655|OG001|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
10902818|NCT00577655|EG000|Reported Event|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day
10902819|NCT00577655|EG001|Reported Event|Placebo|Placebo HFA-MDI four times a day for 21 days.
10902820|NCT00577707|BG000|Baseline|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
10902821|NCT00577707|FG000|Participant Flow|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
10902822|NCT00577707|OG000|Outcome|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
10902823|NCT00577707|EG000|Reported Event|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
10902824|NCT00577720|BG000|Baseline|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
10902825|NCT00577720|BG001|Baseline|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
10902826|NCT00577720|BG002|Baseline|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
10902827|NCT00577720|BG003|Baseline|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
10902828|NCT00577720|BG004|Baseline|Total|Total of all reporting groups
10902829|NCT00577720|FG000|Participant Flow|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
10902830|NCT00577720|FG001|Participant Flow|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
10902831|NCT00577720|FG002|Participant Flow|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
10902832|NCT00577720|FG003|Participant Flow|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
10902833|NCT00577720|OG000|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
10902834|NCT00577720|OG001|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
10902835|NCT00577720|OG002|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
10902836|NCT00577720|OG003|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
11172080|NCT02006836|EG000|Reported Event|Diabetic|Diabetic patients use oral antidiabetic drugs(metformin or pioglitazone or both) or only life style modification. On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of diabetic patients enrolled for the case control period.
10902837|NCT00577720|EG000|Reported Event|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
10902838|NCT00577720|EG001|Reported Event|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
10902839|NCT00577720|EG002|Reported Event|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
10902840|NCT00577720|EG003|Reported Event|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
10902841|NCT00577824|BG000|Baseline|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
10902842|NCT00577824|BG001|Baseline|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
10902843|NCT00577824|BG002|Baseline|Placebo BID|placebo SC, twice daily
10902844|NCT00577824|BG003|Baseline|Total|Total of all reporting groups
10902845|NCT00577824|FG000|Participant Flow|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
10902846|NCT00577824|FG001|Participant Flow|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
10902847|NCT00577824|FG002|Participant Flow|Placebo BID|placebo SC, twice daily
10902848|NCT00577824|OG000|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
10902849|NCT00577824|OG001|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
10902850|NCT00577824|OG002|Outcome|Placebo BID|placebo SC, twice daily
10902851|NCT00577824|EG000|Reported Event|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
10902852|NCT00577824|EG001|Reported Event|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
10902853|NCT00577824|EG002|Reported Event|Placebo BID|placebo SC, twice daily
10902854|NCT00577863|BG000|Baseline|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
10902855|NCT00577863|BG001|Baseline|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
10902856|NCT00577863|BG002|Baseline|Total|Total of all reporting groups
10902857|NCT00577863|FG000|Participant Flow|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
11172081|NCT02006836|EG001|Reported Event|Healthy|On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of volunteers enrolled for the case control period.
11172082|NCT02006836|EG002|Reported Event|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
10902858|NCT00577863|FG001|Participant Flow|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
10902859|NCT00577863|OG000|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
10902860|NCT00577863|OG000|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
10902861|NCT00577863|OG000|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
10902862|NCT00577863|EG000|Reported Event|Teriparatide|Teriparatide 20 micrograms per day
10902863|NCT00577889|BG000|Baseline|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902864|NCT00577889|BG001|Baseline|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902865|NCT00577889|BG002|Baseline|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902866|NCT00577889|BG003|Baseline|Total|Total of all reporting groups
10902867|NCT00577889|FG000|Participant Flow|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902868|NCT00577889|FG001|Participant Flow|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902869|NCT00577889|FG002|Participant Flow|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902870|NCT00577889|OG000|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902871|NCT00577889|OG001|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902872|NCT00577889|OG002|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902873|NCT00577889|EG000|Reported Event|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902874|NCT00577889|EG001|Reported Event|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902875|NCT00577889|EG002|Reported Event|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
10902876|NCT00577993|BG000|Baseline|Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab|Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
10902877|NCT00577993|BG001|Baseline|Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)|Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
10902878|NCT00577993|BG002|Baseline|Patients w/o Bcl Gene Rearrangement|ATT 9 cycles; Rituximab 6 cycles
10902879|NCT00577993|BG003|Baseline|Total|Total of all reporting groups
10902880|NCT00577993|FG000|Participant Flow|Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab|Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
10902881|NCT00577993|FG001|Participant Flow|Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)|Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
10902882|NCT00577993|FG002|Participant Flow|Patients Without Bcl Gene Rearrangement|ATT9 cycles; Rituximab 6 cycles
10902883|NCT00577993|OG000|Outcome|Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab|Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
10902884|NCT00577993|OG001|Outcome|Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)|Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
10902885|NCT00577993|EG000|Reported Event|Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab|Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
10902886|NCT00577993|EG001|Reported Event|Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)|Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
10902887|NCT00578071|BG000|Baseline|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
10902888|NCT00578071|FG000|Participant Flow|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
10902889|NCT00578071|OG000|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
10902890|NCT00578071|OG000|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
11335638|NCT03554018|OG000|Outcome|Acetaminophen|"Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.~Acetaminophen: Acetaminophen 500-1000mg every 6 hours~Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10902891|NCT00578071|EG000|Reported Event|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
10902892|NCT00578136|BG000|Baseline|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
10902893|NCT00578136|BG001|Baseline|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
10902894|NCT00578136|BG002|Baseline|Total|Total of all reporting groups
11090985|NCT01532687|FG001|Participant Flow|Gemcitabine Hydrochloride Plus Placebo|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gemcitabine: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib: Given PO~Pazopanib Hydrochloride: Given PO~Placebo Administration: Given PO"
10902895|NCT00578136|FG000|Participant Flow|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
10902896|NCT00578136|FG001|Participant Flow|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
10902897|NCT00578136|OG000|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
10902898|NCT00578136|OG001|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
10902899|NCT00578136|EG000|Reported Event|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
10902900|NCT00578136|EG001|Reported Event|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
10902901|NCT00578175|BG000|Baseline|Refrigerator-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
10902902|NCT00578175|BG001|Baseline|Freezer-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
10902903|NCT00578175|BG002|Baseline|Proquad Group|Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
10902904|NCT00578175|BG003|Baseline|Total|Total of all reporting groups
10902905|NCT00578175|FG000|Participant Flow|Refrigerator-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
10902906|NCT00578175|FG001|Participant Flow|Freezer-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
10902907|NCT00578175|FG002|Participant Flow|Proquad Group|Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
10902908|NCT00578175|OG000|Outcome|Refrigerator-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
10902909|NCT00578175|OG001|Outcome|Freezer-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
10902910|NCT00578175|OG002|Outcome|Proquad Group|Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
10902911|NCT00578175|OG000|Outcome|Refrigerator-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. .
10902912|NCT00578175|OG002|Outcome|ProQuad Group|Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
10902913|NCT00578175|EG000|Reported Event|Refrigerator-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
10902914|NCT00578175|EG001|Reported Event|Freezer-stored Priorix-Tetra Group|Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
10902915|NCT00578175|EG002|Reported Event|Proquad Group|Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
10902916|NCT00578214|BG000|Baseline|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
10902917|NCT00578214|BG001|Baseline|Placebo|Randomized patients receiving placebo syrup
10902918|NCT00578214|BG002|Baseline|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
10902919|NCT00578214|BG003|Baseline|Total|Total of all reporting groups
10902920|NCT00578214|FG000|Participant Flow|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
10902921|NCT00578214|FG001|Participant Flow|Placebo|Randomized patients receiving placebo syrup
10902922|NCT00578214|FG002|Participant Flow|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
10902923|NCT00578214|OG000|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
10902924|NCT00578214|OG001|Outcome|Placebo|Randomized patients receiving placebo syrup
10902925|NCT00578214|OG002|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
10902926|NCT00578214|EG000|Reported Event|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
10902927|NCT00578214|EG001|Reported Event|Placebo|Randomized patients receiving placebo syrup
10902928|NCT00578214|EG002|Reported Event|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
10902929|NCT00578227|BG000|Baseline|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
10902930|NCT00578227|BG001|Baseline|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
10902931|NCT00578227|BG002|Baseline|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
10902932|NCT00578227|BG003|Baseline|Total|Total of all reporting groups
10902933|NCT00578227|FG000|Participant Flow|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
10902934|NCT00578227|FG001|Participant Flow|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
10902935|NCT00578227|FG002|Participant Flow|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
10902936|NCT00578227|OG000|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
10902937|NCT00578227|OG001|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
10902938|NCT00578227|OG002|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
10902939|NCT00578227|OG002|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
10902940|NCT00578227|OG003|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
10902941|NCT00578227|EG000|Reported Event|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
10902942|NCT00578227|EG001|Reported Event|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
10902943|NCT00578227|EG002|Reported Event|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
10902944|NCT00578279|BG000|Baseline|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
10902945|NCT00578279|BG001|Baseline|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
10902946|NCT00578279|BG002|Baseline|Total|Total of all reporting groups
10902947|NCT00578279|FG000|Participant Flow|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
10902948|NCT00578279|FG001|Participant Flow|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
10902949|NCT00578279|OG000|Outcome|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
10902950|NCT00578279|OG001|Outcome|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
10902951|NCT00578279|EG000|Reported Event|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
10902952|NCT00578279|EG001|Reported Event|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
10902953|NCT00578292|BG000|Baseline|Bone Marrow or Stem Cell Infusion|"Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H~Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.~Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.~Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg~Days -9 through -6~Fludarabine: 30mg/m2 Day -5 through Day -2~Campath 1H: Per institutional guidelines Days -5 through -2~Cyclophosphamide: 50 mg/kg Days -5 through -2~MESNA: 10 mg/kg x 5 Days -5 through -2"
10902954|NCT00578292|FG000|Participant Flow|Bone Marrow or Stem Cell Infusion|"Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H~Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.~Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.~Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg~Days -9 through -6~Fludarabine: 30mg/m2 Day -5 through Day -2~Campath 1H: Per institutional guidelines Days -5 through -2~Cyclophosphamide: 50 mg/kg Days -5 through -2~MESNA: 10 mg/kg x 5 Days -5 through -2"
10902955|NCT00578292|OG000|Outcome|Bone Marrow or Stem Cell Infusion|"Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H~Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.~Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.~Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg~Days -9 through -6~Fludarabine: 30mg/m2 Day -5 through Day -2~Campath 1H: Per institutional guidelines Days -5 through -2~Cyclophosphamide: 50 mg/kg Days -5 through -2~MESNA: 10 mg/kg x 5 Days -5 through -2"
10902956|NCT00578292|EG000|Reported Event|Bone Marrow or Stem Cell Infusion|"Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H~Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.~Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.~Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg~Days -9 through -6~Fludarabine: 30mg/m2 Day -5 through Day -2~Campath 1H: Per institutional guidelines Days -5 through -2~Cyclophosphamide: 50 mg/kg Days -5 through -2~MESNA: 10 mg/kg x 5 Days -5 through -2"
10902957|NCT00578305|BG000|Baseline|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902958|NCT00578305|BG001|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902959|NCT00578305|BG002|Baseline|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902960|NCT00578305|BG003|Baseline|Total|Total of all reporting groups
10902961|NCT00578305|FG000|Participant Flow|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902962|NCT00578305|FG001|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902963|NCT00578305|FG002|Participant Flow|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902964|NCT00578305|OG000|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902965|NCT00578305|OG001|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902966|NCT00578305|OG002|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902967|NCT00578305|EG000|Reported Event|Rituximab 500 mg - Double-blind Treatment Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902968|NCT00578305|EG001|Reported Event|Rituximab 1000 mg - Double-blind Treatment Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902969|NCT00578305|EG002|Reported Event|Placebo - Double-blind Treatment Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902970|NCT00578305|EG003|Reported Event|Rituximab 500 mg - Extension Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902971|NCT00578305|EG004|Reported Event|Rituximab 1000 mg - Extension Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902972|NCT00578305|EG005|Reported Event|Placebo - Extension Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902973|NCT00578305|EG006|Reported Event|Rituximab 500 mg - Safety Follow-up Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902974|NCT00578305|EG007|Reported Event|Rituximab 1000 mg - Safety Follow-up Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902975|NCT00578305|EG008|Reported Event|Placebo - Safety Follow-up Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
10902976|NCT00578318|BG000|Baseline|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
10902977|NCT00578318|BG001|Baseline|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
10902978|NCT00578318|BG002|Baseline|Total|Total of all reporting groups
10902979|NCT00578318|FG000|Participant Flow|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
10902980|NCT00578318|FG001|Participant Flow|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
10902981|NCT00578318|OG000|Outcome|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
10902982|NCT00578318|OG001|Outcome|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
10902983|NCT00578318|EG000|Reported Event|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
10902984|NCT00578318|EG001|Reported Event|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
10902985|NCT00578331|BG000|Baseline|Placebo Nasal Spray|
10902986|NCT00578331|BG001|Baseline|Olopatadine 0.6% Nasal Spray|
10902987|NCT00578331|BG002|Baseline|Total|Total of all reporting groups
10902988|NCT00578331|FG000|Participant Flow|Placebo Nasal Spray|2 sprays each nostril twice daily
10902989|NCT00578331|FG001|Participant Flow|Olopatadine 0.6% Nasal Spray|2 sprays each nostril twice daily
10902990|NCT00578331|OG000|Outcome|Placebo Nasal Spray|
10902991|NCT00578331|OG001|Outcome|Olopatadine 0.6% Nasal Spray|
10902992|NCT00578331|EG000|Reported Event|Placebo Nasal Spray|
10902993|NCT00578331|EG001|Reported Event|Olopatadine 0.6% Nasal Spray|
10902994|NCT00578344|BG000|Baseline|Allogeneic BMT/SCT Transplant|"Busulfan, Campath 1H, Cyclophosphamide and MESNA:~Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.~Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.~Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.~Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.~Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA."
10902995|NCT00578344|FG000|Participant Flow|Allogeneic BMT/SCT Transplant|"Busulfan, Campath 1H, Cyclophosphamide and MESNA:~Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.~Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.~Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.~Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.~Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA."
10902996|NCT00578344|OG000|Outcome|Allogeneic BMT/SCT Transplant|"Busulfan, Campath 1H, Cyclophosphamide and MESNA:~Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.~Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.~Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.~Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.~Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA."
10914970|NCT00633594|BG002|Baseline|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
10914971|NCT00633594|BG003|Baseline|Total|Total of all reporting groups
10902997|NCT00578344|EG000|Reported Event|Allogeneic BMT/SCT Transplant|"Busulfan, Campath 1H, Cyclophosphamide and MESNA:~Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.~Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.~Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.~Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.~Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA."
10902998|NCT00578383|BG000|Baseline|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
10902999|NCT00578383|BG001|Baseline|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903000|NCT00578383|BG002|Baseline|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
10903001|NCT00578383|BG003|Baseline|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903002|NCT00578383|BG004|Baseline|Total|Total of all reporting groups
10903003|NCT00578383|FG000|Participant Flow|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
10903004|NCT00578383|FG001|Participant Flow|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903005|NCT00578383|FG002|Participant Flow|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
10903006|NCT00578383|FG003|Participant Flow|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903007|NCT00578383|OG000|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
10903008|NCT00578383|OG001|Outcome|Combined Group Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903009|NCT00578383|OG001|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903010|NCT00578383|OG000|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
10903011|NCT00578383|OG000|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
10903012|NCT00578383|OG001|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903013|NCT00578383|OG000|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
10903014|NCT00578383|OG001|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
10903015|NCT00578383|EG000|Reported Event|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
10903016|NCT00578383|EG001|Reported Event|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903017|NCT00578383|EG002|Reported Event|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
10903018|NCT00578383|EG003|Reported Event|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
10903019|NCT00578448|BG000|Baseline|IV Belatacept 10mg/kg With 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial.
10903020|NCT00578448|FG000|Participant Flow|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial (3 years and then a 1 year extension was available for those who completed the 3rd year).
10903021|NCT00578448|OG000|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
10903022|NCT00578448|OG000|Outcome|10mg/kg IV Belatacept|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
10903023|NCT00578448|OG000|Outcome|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study (3 years planned study; 1 year extension allowed to those who completed 3rd year).
10903024|NCT00578448|EG000|Reported Event|Bela 10-5mg/kg|
10903025|NCT00578461|BG000|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
10903026|NCT00578461|FG000|Participant Flow|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.~Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.~Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
10903027|NCT00578461|OG000|Outcome|Stem Cell Transplant|All patients will be receiving a stem cell transplant on study. Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation.
10903028|NCT00578461|EG000|Reported Event|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.~Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
10903029|NCT00578539|BG000|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
10903030|NCT00578539|FG000|Participant Flow|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
10903031|NCT00578539|OG000|Outcome|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
10903032|NCT00578539|EG000|Reported Event|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
10903033|NCT00578552|BG000|Baseline|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903034|NCT00578552|BG001|Baseline|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903035|NCT00578552|BG002|Baseline|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903036|NCT00578552|BG003|Baseline|Total|Total of all reporting groups
10903037|NCT00578552|FG000|Participant Flow|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903038|NCT00578552|FG001|Participant Flow|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903039|NCT00578552|FG002|Participant Flow|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903040|NCT00578552|OG000|Outcome|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903041|NCT00578552|OG001|Outcome|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903042|NCT00578552|OG002|Outcome|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903043|NCT00578552|EG000|Reported Event|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903044|NCT00578552|EG001|Reported Event|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903045|NCT00578552|EG002|Reported Event|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
10903046|NCT00578565|BG000|Baseline|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
10903047|NCT00578565|FG000|Participant Flow|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
10903048|NCT00578565|OG000|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
10903049|NCT00578565|OG000|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
10903050|NCT00578565|EG000|Reported Event|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
10903051|NCT00578617|BG000|Baseline|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
10903052|NCT00578617|BG001|Baseline|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
10903053|NCT00578617|BG002|Baseline|Total|Total of all reporting groups
10903054|NCT00578617|FG000|Participant Flow|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
10903055|NCT00578617|FG001|Participant Flow|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
10903056|NCT00578617|OG000|Outcome|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
10903057|NCT00578617|OG001|Outcome|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
10903058|NCT00578617|EG000|Reported Event|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
10903059|NCT00578617|EG001|Reported Event|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
10914972|NCT00633594|FG000|Participant Flow|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1-14.
10914973|NCT00633594|FG001|Participant Flow|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
10903060|NCT00578643|BG000|Baseline|Allogeneic Unrelated Transplant|"Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion.~Busulfan: Days -9 through -6~1 mg/kg initially (based on weight)~Alemtuzumab: Day -5 through Day -2~Dose is based on weight:~Less than 15 kg: 3 mg~More than 15 kg to 30 kg: 5 mg~More than 30 kg: 15 mg~Cyclophosphamide: Days -5 through -2~50 mg/kg~Fludarabine: Day -5 through Day -2~30 mg/m^2~Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours.~Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells."
10903061|NCT00578643|FG000|Participant Flow|Allogeneic Unrelated Transplant|"Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion.~Busulfan: Days -9 through -6~1 mg/kg initially (based on weight)~Alemtuzumab: Day -5 through Day -2~Dose is based on weight:~Less than 15 kg: 3 mg~More than 15 kg to 30 kg: 5 mg~More than 30 kg: 15 mg~Cyclophosphamide: Days -5 through -2~50 mg/kg~Fludarabine: Day -5 through Day -2~30 mg/m^2~Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours.~Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells."
10903062|NCT00578643|OG000|Outcome|Allogeneic Unrelated Transplant|"Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion.~Busulfan: Days -9 through -6~1 mg/kg initially (based on weight)~Alemtuzumab: Day -5 through Day -2~Dose is based on weight:~Less than 15 kg: 3 mg~More than 15 kg to 30 kg: 5 mg~More than 30 kg: 15 mg~Cyclophosphamide: Days -5 through -2~50 mg/kg~Fludarabine: Day -5 through Day -2~30 mg/m^2~Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours.~Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells."
10903063|NCT00578643|EG000|Reported Event|Allogeneic Unrelated Transplant|"Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion.~Busulfan: Days -9 through -6~1 mg/kg initially (based on weight)~Alemtuzumab: Day -5 through Day -2~Dose is based on weight:~Less than 15 kg: 3 mg~More than 15 kg to 30 kg: 5 mg~More than 30 kg: 15 mg~Cyclophosphamide: Days -5 through -2~50 mg/kg~Fludarabine: Day -5 through Day -2~30 mg/m^2~Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours.~Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells."
10903064|NCT00578669|BG000|Baseline|Sequential Placebo|"Participants received placebo medication, dextrose, that was begun 8 weeks prior to and extended throughout the brief, behavioral standard smoking cessation treatment that included transdermal nicotine patch.~The placebo medication (dextrose) was taken once daily for 16 weeks."
10903065|NCT00578669|BG001|Baseline|Sequential Fluoxetine|"Participants received fluoxetine medication, 20 mg, that was begun 8 weeks prior to and extended throughout the brief, behavioral standard smoking cessation treatment that included transdermal nicotine patch.~The fluoxetine medication (20 mg) was taken once daily for 16 weeks."
10903066|NCT00578669|BG002|Baseline|Total|Total of all reporting groups
10903067|NCT00578669|FG000|Participant Flow|Sequential Fluoxetine|"Sequential Fluoxetine - Participants received sequential antidepressant pharmacotherapy (fluoxetine - 20 mg.) that was begun 8 weeks prior to, and extended throughout the treatment phase. The treatment phase consisted of 8 weeks of brief behavioral counseling and transdermal nicotine patches.~Fluoxetine was used once daily for 16 weeks."
10903068|NCT00578669|FG001|Participant Flow|Sequential Placebo|"Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout the 8-week brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.~Dextrose was used once daily for 16 weeks"
10903069|NCT00578669|OG000|Outcome|Sequential Fluoxetine|"Sequential Fluoxetine - Participants received sequential antidepressant pharmacotherapy (fluoxetine - 20 mg.) that was begun 8 weeks prior to, and extended throughout the treatment phase. The treatment phase consisted of 8 weeks of brief behavioral counseling and transdermal nicotine patches.~Fluoxetine was used once daily for 16 weeks."
10903070|NCT00578669|OG001|Outcome|Sequential Placebo|"Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout the 8-week brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.~Dextrose was used once daily for 16 weeks"
10903071|NCT00578669|EG000|Reported Event|Sequential Fluoxetine|"Sequential antidepressant pharmacotherapy with (20mg) fluoxetine, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.~Fluoxetine: 20mg once daily for 16 weeks"
10903072|NCT00578669|EG001|Reported Event|Sequential Placebo|"Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.~Dextrose: Once daily for 16 weeks"
10903073|NCT00578734|BG000|Baseline|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
10903074|NCT00578734|BG001|Baseline|Sham Air|Sham air (placebo) instillation
10903075|NCT00578734|BG002|Baseline|Total|Total of all reporting groups
10903076|NCT00578734|FG000|Participant Flow|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
10903077|NCT00578734|FG001|Participant Flow|Sham Air|Sham air (placebo) instillation
10903078|NCT00578734|OG000|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
10903079|NCT00578734|OG001|Outcome|Sham Air|Sham air (placebo) instillation
10903080|NCT00578734|EG000|Reported Event|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
10903081|NCT00578734|EG001|Reported Event|Sham Air|Sham air (placebo) instillation
10903082|NCT00578786|BG000|Baseline|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
10903083|NCT00578786|BG001|Baseline|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
10903084|NCT00578786|BG002|Baseline|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
10903085|NCT00578786|BG003|Baseline|Total|Total of all reporting groups
10903086|NCT00578786|FG000|Participant Flow|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
10903087|NCT00578786|FG001|Participant Flow|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
10903088|NCT00578786|FG002|Participant Flow|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
10903089|NCT00578786|OG000|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903090|NCT00578786|OG001|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903091|NCT00578786|OG002|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903092|NCT00578786|OG003|Outcome|Combined Ambrisentan Group|All dose groups combined.
10903093|NCT00578786|OG000|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903094|NCT00578786|OG001|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903095|NCT00578786|OG002|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903096|NCT00578786|OG003|Outcome|Ambrisentan Combined Group|All dose groups combined.
10903097|NCT00578786|OG000|Outcome|Combined Ambrisentan Group|All dose groups combined.
10903098|NCT00578786|OG000|Outcome|Combined Ambrisentan Group|(All Doses)
10903099|NCT00578786|OG000|Outcome|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903100|NCT00578786|OG001|Outcome|Ambrisentan 5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903101|NCT00578786|OG002|Outcome|Ambrisentan 10 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903102|NCT00578786|EG000|Reported Event|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903103|NCT00578786|EG001|Reported Event|Ambrisentan 5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903104|NCT00578786|EG002|Reported Event|Ambrisentan 10 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
10903105|NCT00578812|BG000|Baseline|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903106|NCT00578812|BG001|Baseline|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903107|NCT00578812|BG002|Baseline|Total|Total of all reporting groups
10903108|NCT00578812|FG000|Participant Flow|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903109|NCT00578812|FG001|Participant Flow|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903110|NCT00578812|OG000|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903111|NCT00578812|OG001|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903112|NCT00578812|OG000|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903113|NCT00578812|EG000|Reported Event|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903114|NCT00578812|EG001|Reported Event|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
10903115|NCT00578864|BG000|Baseline|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
10903116|NCT00578864|BG001|Baseline|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
10903117|NCT00578864|BG002|Baseline|Total|Total of all reporting groups
10903118|NCT00578864|FG000|Participant Flow|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
10903119|NCT00578864|FG001|Participant Flow|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
10903120|NCT00578864|OG000|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
10903121|NCT00578864|OG001|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
10903122|NCT00578864|EG000|Reported Event|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
10903123|NCT00578864|EG001|Reported Event|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
10903124|NCT00578877|BG000|Baseline|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
10903125|NCT00578877|BG001|Baseline|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
10903126|NCT00578877|BG002|Baseline|Total|Total of all reporting groups
10903127|NCT00578877|FG000|Participant Flow|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
10903128|NCT00578877|FG001|Participant Flow|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
10903129|NCT00578877|OG000|Outcome|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
10903130|NCT00578877|OG001|Outcome|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
10903131|NCT00578877|EG000|Reported Event|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
10903132|NCT00578877|EG001|Reported Event|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
10903133|NCT00578903|BG000|Baseline|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
10903134|NCT00578903|FG000|Participant Flow|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
10903135|NCT00578903|OG000|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
10903136|NCT00578903|EG000|Reported Event|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
10903137|NCT00578929|BG000|Baseline|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
10903138|NCT00578929|BG001|Baseline|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
10903139|NCT00578929|BG002|Baseline|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
10903140|NCT00578929|BG003|Baseline|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
10903141|NCT00578929|BG004|Baseline|Total|Total of all reporting groups
10903142|NCT00578929|FG000|Participant Flow|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
10903143|NCT00578929|FG001|Participant Flow|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
10903144|NCT00578929|FG002|Participant Flow|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
10903145|NCT00578929|FG003|Participant Flow|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
10903146|NCT00578929|OG000|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
10903147|NCT00578929|OG001|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
10903148|NCT00578929|OG002|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
10903149|NCT00578929|OG003|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
10903150|NCT00578929|EG000|Reported Event|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
10903151|NCT00578929|EG001|Reported Event|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
10903152|NCT00578929|EG002|Reported Event|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
10903153|NCT00578929|EG003|Reported Event|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
10903154|NCT00578929|EG004|Reported Event|Vehicle Run-in Period|Vehicle Run-in Period
10903155|NCT00578942|BG000|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
10903156|NCT00578942|FG000|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
10903157|NCT00578942|OG000|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
10903158|NCT00578942|EG000|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
10903159|NCT00578968|BG000|Baseline|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
10903160|NCT00578968|BG001|Baseline|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
10903161|NCT00578968|BG002|Baseline|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
10903162|NCT00578968|BG003|Baseline|Total|Total of all reporting groups
10903163|NCT00578968|FG000|Participant Flow|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
10903164|NCT00578968|FG001|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
10903165|NCT00578968|FG002|Participant Flow|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
10903166|NCT00578968|OG000|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
11335639|NCT03554018|OG001|Outcome|Placebo|"Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.~Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)~Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours"
10903167|NCT00578968|OG001|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
10903168|NCT00578968|OG000|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
10903169|NCT00578968|OG001|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
10903170|NCT00578968|EG000|Reported Event|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
10903171|NCT00578968|EG001|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
10903172|NCT00578968|EG002|Reported Event|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
10903173|NCT00579059|BG000|Baseline|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
10903174|NCT00579059|BG001|Baseline|Maxim® Regular Tibia|Tibia with Modular Polyethylene
10903175|NCT00579059|BG002|Baseline|Total|Total of all reporting groups
10903176|NCT00579059|FG000|Participant Flow|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
10903177|NCT00579059|FG001|Participant Flow|Maxim® Regular Tibia|Tibia with Modular Polyethylene
10903178|NCT00579059|OG000|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
10903179|NCT00579059|OG001|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
10903180|NCT00579059|EG000|Reported Event|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
10903181|NCT00579059|EG001|Reported Event|Maxim® Regular Tibia|Tibia with Modular Polyethylene
10903182|NCT00579098|BG000|Baseline|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
10903183|NCT00579098|BG001|Baseline|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
10903184|NCT00579098|BG002|Baseline|Total|Total of all reporting groups
10903185|NCT00579098|FG000|Participant Flow|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
10903186|NCT00579098|FG001|Participant Flow|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
10903187|NCT00579098|OG000|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
10903188|NCT00579098|OG001|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
10903189|NCT00579098|EG000|Reported Event|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
10903190|NCT00579098|EG001|Reported Event|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
10903191|NCT00579111|BG000|Baseline|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
10903192|NCT00579111|BG001|Baseline|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
10903193|NCT00579111|BG002|Baseline|Total|Total of all reporting groups
10903194|NCT00579111|FG000|Participant Flow|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
10903195|NCT00579111|FG001|Participant Flow|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
10903196|NCT00579111|OG000|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
10903197|NCT00579111|OG001|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
10903198|NCT00579111|EG000|Reported Event|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
10903199|NCT00579111|EG001|Reported Event|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
10903200|NCT00579137|BG000|Baseline|Single Group|only one group
10903201|NCT00579137|FG000|Participant Flow|Participants With SCID or Primary Immunodeficiency Disorder|"Participants received an allogeneic stem cell transplant with the following conditioning:~Day 8 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D7 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D6 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D5 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D4 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D3 Anti-CD45 MAb 400ug/kg over 6 hr~D2 Anti-CD45 MAb 400ug/kg over 6 hr~D1 rest~D0 Stem Cell Infusion~Campath dose is weight based: for patients less than 15 kg administer Campath 3 mg; for patients >15 kg to 30 kg administer Campath 5 mg; for patients > 30 kg administer Campath 10 mg. Campath will be dosed and administered as per CAGT SOP.~Anti-CD45 infusion will be administered according to CAGT SOPs."
10903202|NCT00579137|OG000|Outcome|Single Group|only one group
10903203|NCT00579137|EG000|Reported Event|Single Group|only one group
10903204|NCT00579280|BG000|Baseline|Quetiapine SR|Quetiapine SR (sustained release)
10903205|NCT00579280|BG001|Baseline|Divalproex Sodium ER|Divalproex Sodium ER (extended release)
10903206|NCT00579280|BG002|Baseline|Placebo|Placebo control
10903207|NCT00579280|BG003|Baseline|Total|Total of all reporting groups
10903208|NCT00579280|FG000|Participant Flow|Quetiapine SR|Quetiapine SR (sustained release)
10903209|NCT00579280|FG001|Participant Flow|Divalproex Sodium ER|Divalproex Sodium ER (extended release)
10903210|NCT00579280|FG002|Participant Flow|Placebo|Placebo control
10903211|NCT00579280|OG000|Outcome|Quetiapine SR|"Quetiapine SR~quetiapine SR: flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks"
10903212|NCT00579280|OG001|Outcome|Divalproex Sodium ER|"Divalproex Sodium ER~divalproex sodium ER: Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks"
10903213|NCT00579280|OG002|Outcome|Placebo|"placebo~placebo: placebo"
10903214|NCT00579280|EG000|Reported Event|Quetiapine SR|Quetiapine SR (sustained release)
10903215|NCT00579280|EG001|Reported Event|Divalproex Sodium ER|Divalproex Sodium ER (extended release)
10903216|NCT00579280|EG002|Reported Event|Placebo|Placebo control
10903217|NCT00579345|BG000|Baseline|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903218|NCT00579345|BG001|Baseline|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10903219|NCT00579345|BG002|Baseline|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903220|NCT00579345|BG003|Baseline|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10903221|NCT00579345|BG004|Baseline|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
10903222|NCT00579345|BG005|Baseline|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903223|NCT00579345|BG006|Baseline|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903224|NCT00579345|BG007|Baseline|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903225|NCT00579345|BG008|Baseline|Total|Total of all reporting groups
10903226|NCT00579345|FG000|Participant Flow|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903227|NCT00579345|FG001|Participant Flow|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10903228|NCT00579345|FG002|Participant Flow|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903229|NCT00579345|FG003|Participant Flow|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10903230|NCT00579345|FG004|Participant Flow|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
10903231|NCT00579345|FG005|Participant Flow|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903232|NCT00579345|FG006|Participant Flow|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903233|NCT00579345|FG007|Participant Flow|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903234|NCT00579345|OG000|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903235|NCT00579345|OG001|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10914974|NCT00633594|FG002|Participant Flow|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
10903236|NCT00579345|OG002|Outcome|cTIV (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903237|NCT00579345|OG003|Outcome|eTIV_a (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10903238|NCT00579345|OG000|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV)).
10903239|NCT00579345|OG001|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)).
10903240|NCT00579345|OG002|Outcome|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study.
10903241|NCT00579345|OG003|Outcome|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
10903242|NCT00579345|OG004|Outcome|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
10903243|NCT00579345|OG005|Outcome|eTIV_a+PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
10903244|NCT00579345|OG000|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
10903245|NCT00579345|OG001|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
10903246|NCT00579345|OG000|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903247|NCT00579345|OG001|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10903248|NCT00579345|OG002|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
10903249|NCT00579345|OG003|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
10903250|NCT00579345|OG000|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV).
10903251|NCT00579345|OG001|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
10903252|NCT00579345|EG000|Reported Event|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903253|NCT00579345|EG001|Reported Event|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10903254|NCT00579345|EG002|Reported Event|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
10903255|NCT00579345|EG003|Reported Event|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
10903256|NCT00579345|EG004|Reported Event|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
10903257|NCT00579345|EG005|Reported Event|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age)were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903258|NCT00579345|EG006|Reported Event|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age)were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903259|NCT00579345|EG007|Reported Event|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
10903260|NCT00579436|BG000|Baseline|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
10903261|NCT00579436|BG001|Baseline|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
10903262|NCT00579436|BG002|Baseline|Total|Total of all reporting groups
10903263|NCT00579436|FG000|Participant Flow|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
10903264|NCT00579436|FG001|Participant Flow|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
10903265|NCT00579436|OG000|Outcome|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
10903266|NCT00579436|OG001|Outcome|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
10903267|NCT00579436|EG000|Reported Event|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
10903268|NCT00579436|EG001|Reported Event|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
10903269|NCT00579501|BG000|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
10903270|NCT00579501|FG000|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
10903271|NCT00579501|OG000|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
10903272|NCT00579501|EG000|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
10903273|NCT00579553|BG000|Baseline|Intramuscular Progesterone|"Intramuscular Progesterone~Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P"
10903274|NCT00579553|BG001|Baseline|Vaginal Progesterone|"Vaginal Progesterone~Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily"
10903275|NCT00579553|BG002|Baseline|Total|Total of all reporting groups
10903276|NCT00579553|FG000|Participant Flow|Intramuscular Progesterone|"Intramuscular Progesterone~Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P"
10903277|NCT00579553|FG001|Participant Flow|Vaginal Progesterone|"Vaginal Progesterone~Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily"
10903278|NCT00579553|OG000|Outcome|Intramuscular Progesterone|"Intramuscular Progesterone~Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P"
10903279|NCT00579553|OG001|Outcome|Vaginal Progesterone|"Vaginal Progesterone~Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily"
10903280|NCT00579553|EG000|Reported Event|Intramuscular Progesterone|"Intramuscular Progesterone~Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P"
10903281|NCT00579553|EG001|Reported Event|Vaginal Progesterone|"Vaginal Progesterone~Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily"
10903282|NCT00579670|BG000|Baseline|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
10903283|NCT00579670|BG001|Baseline|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
10903284|NCT00579670|BG002|Baseline|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
10903285|NCT00579670|BG003|Baseline|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
10903286|NCT00579670|BG004|Baseline|Ziprasidone Unknown|Details are unknown.
11233395|NCT02427399|EG003|Reported Event|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
10903287|NCT00579670|BG005|Baseline|Total|Total of all reporting groups
10903288|NCT00579670|FG000|Participant Flow|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
10903289|NCT00579670|FG001|Participant Flow|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
10903290|NCT00579670|FG002|Participant Flow|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
10903291|NCT00579670|FG003|Participant Flow|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
10903292|NCT00579670|FG004|Participant Flow|Ziprasidone Unknown|Details are unknown.
11090986|NCT01532687|OG000|Outcome|Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gemcitabine: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib: Given PO~Pazopanib Hydrochloride: Given PO"
10903293|NCT00579670|OG000|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
10903294|NCT00579670|OG001|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
10903295|NCT00579670|OG002|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
10903296|NCT00579670|OG003|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
10903297|NCT00579670|OG004|Outcome|Ziprasidone Unknown|Details are unknown.
10903298|NCT00579670|OG000|Outcome|Ziprasidone Total|Ziprasidone all doses received combined.
10903299|NCT00579670|OG000|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
10903300|NCT00579670|OG004|Outcome|Ziprasodone Unknown|Details are unknown.
10903301|NCT00579670|OG000|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
10903302|NCT00579670|OG001|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
10903303|NCT00579670|OG002|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
10903304|NCT00579670|OG003|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
10903305|NCT00579670|EG000|Reported Event|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
10903306|NCT00579670|EG001|Reported Event|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
10903307|NCT00579670|EG002|Reported Event|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
10903308|NCT00579670|EG003|Reported Event|Ziprasidone >=160 mg|Ziprasidone 160 mg or greater per day.
10903309|NCT00579670|EG004|Reported Event|Ziprasidone Unknown|Details are unknown.
10903310|NCT00579670|EG005|Reported Event|Within SmPC Ziprasidone < 80 mg|Within SmPC < 80 mg per day; defined as all participants in the FAS population who had PO doses up to 80 mg per day and all IM doses up to and including 40 mg per day.
10903311|NCT00579670|EG006|Reported Event|Within SmPC Ziprasidone 80 to < 120 mg|Within SmPC Ziprasidone 80 to < 120 mg; defined as all participants in the FAS population who had PO doses between 80 mg and < 120 mg per day.
10903312|NCT00579670|EG007|Reported Event|Within SmPC Ziprasidone 120 to < 160 mg|Within SmPC Ziprasidone 120 to < 160 mg; defined as all participants in the FAS population who had PO doses between 120 mg and < 160 mg per day.
10903313|NCT00579670|EG008|Reported Event|Within SmPC Ziprasidone = 160 mg|Within SmPC Ziprasidone = 160 mg; defined as all participants in the FAS population who had PO doses = 160 mg per day.
10903314|NCT00579670|EG009|Reported Event|Above SmPC Ziprasidone > 160 mg|Above SmPC Ziprasidone > 160 mg per day; defined as all participants in FAS population who received at least 1 PO dose above 160 mg per day or any IM dose above 40 mg per day or with an unknown dose or formulation.
10903315|NCT00579813|BG000|Baseline|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
10903316|NCT00579813|BG001|Baseline|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
10903317|NCT00579813|BG002|Baseline|Total|Total of all reporting groups
10903318|NCT00579813|FG000|Participant Flow|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
11172083|NCT02006836|EG003|Reported Event|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
10903319|NCT00579813|FG001|Participant Flow|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
10903320|NCT00579813|OG000|Outcome|Obese Subjects, Baseline|Baseline studies, obese
10903321|NCT00579813|OG001|Outcome|After Pioiglitazone|10 weeks of treatment
10903322|NCT00579813|OG002|Outcome|Lean Subjects, Baseline|lean subjects, baseline
10903323|NCT00579813|EG000|Reported Event|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
10903324|NCT00579813|EG001|Reported Event|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
10903325|NCT00579878|BG000|Baseline|1- Leflunomide Alone - vs Combination Therapy|"Group A: Leflunomide alone~Leflunomide: A loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations~Leflunomide: a loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations)."
10903326|NCT00579878|BG001|Baseline|Methotrexate-Sulfasalazine-Hydroxychloroquine|"Methotrexate: Dose will start at 10mg/week. If total remission (according to ACR criteria) has not been achieved and labs are acceptable at the 8-week evaluation, the dosage will be increased to a dose of 15 mg/week Accordingly, if total remission has not been achieved and labs remain acceptable at the 16-week evaluation, the dosage will be increased to the top dose of 20 mg/week This dose will remain stable until the end of the study.~Sulfasalazine: Dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable, the dosage will be increased to the top dose of 1000 mg bid (2000 mg/day)~Hydroxychloroquine: Dosing will be started and maintained throughout the study at a dose of 200 mg bid (400 mg/day).~Intervention will remain as listed above.~Methotrexate-Sulfasalazine-Hydroxychloroquine: Methotrexate:~dosing starts at 10mg/week (4 tabs/wk"
11172084|NCT02006888|BG000|Baseline|IBI-10090 Low Dose|"IBI-10090 low dose~IBI-10090"
11172085|NCT02006888|BG001|Baseline|IBI-10090 Med Dose|"IBI-10090 med dose~IBI-10090"
11172086|NCT02006888|BG002|Baseline|Placebo|"Placebo~Placebo: Placebo"
11172087|NCT02006888|BG003|Baseline|Total|Total of all reporting groups
11172088|NCT02006888|FG000|Participant Flow|IBI-10090 Low Dose|"IBI-10090 low dose~IBI-10090"
10903327|NCT00579878|BG002|Baseline|Leflunomide-Sulfasalazine-Hydroxychloroquine|Leflunomide-Sulfasalazine-Hydroxychloroquine: Leflunomide: dose of 100 mg (or placebo) for three (3) days. Followed by a dose of 20 mg/day will be maintained throughout the remainder of the study. dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur Sulfasalazine: dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable, dose will be increased to 1000 mg bid (2000 mg/day) Hydroxychloroquine: dosing will be started and maintained throughout the study at 200 mg bid (400 mg/day).
10903328|NCT00579878|BG003|Baseline|Total|Total of all reporting groups
10903329|NCT00579878|FG000|Participant Flow|1- Leflunomide Alone - vs Combination Therapy|"Group A: Leflunomide alone~Leflunomide: A loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations~Leflunomide: a loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations)."
10903330|NCT00579878|FG001|Participant Flow|Methotrexate-Sulfasalazine-Hydroxychloroquine|"Methotrexate: Dose will start at 10mg/week. If total remission (according to ACR criteria) has not been achieved and labs are acceptable at the 8-week evaluation, the dosage will be increased to a dose of 15 mg/week Accordingly, if total remission has not been achieved and labs remain acceptable at the 16-week evaluation, the dosage will be increased to the top dose of 20 mg/week This dose will remain stable until the end of the study.~Sulfasalazine: Dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable, the dosage will be increased to the top dose of 1000 mg bid (2000 mg/day)~Hydroxychloroquine: Dosing will be started and maintained throughout the study at a dose of 200 mg bid (400 mg/day).~Intervention will remain as listed above.~Methotrexate-Sulfasalazine-Hydroxychloroquine: Methotrexate:~dosing starts at 10mg/week (4 tabs/wk"
10914975|NCT00633594|OG000|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
11172089|NCT02006888|FG001|Participant Flow|IBI-10090 Med Dose|"IBI-10090 med dose~IBI-10090"
11172090|NCT02006888|FG002|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
10903331|NCT00579878|FG002|Participant Flow|Leflunomide-Sulfasalazine-Hydroxychloroquine|Leflunomide-Sulfasalazine-Hydroxychloroquine: Leflunomide: dose of 100 mg (or placebo) for three (3) days. Followed by a dose of 20 mg/day will be maintained throughout the remainder of the study. dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur Sulfasalazine: dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable, dose will be increased to 1000 mg bid (2000 mg/day) Hydroxychloroquine: dosing will be started and maintained throughout the study at 200 mg bid (400 mg/day).
10903332|NCT00579878|OG000|Outcome|1 Leflunomide Alone vs Combination Therapy|"Group A: Leflunomide alone~Leflunomide: A loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations~Leflunomide: a loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations)."
10903333|NCT00579878|OG001|Outcome|Methotrexate-Sulfasalazine-Hydroxychloroquine|"Methotrexate: start 10mg/wk. If total remission (ACR criteria) not achieved, labs acceptable at 8-wks, dose will increase to 15 mg/wk. If total remission not achieved, labs acceptable at16-wks, dose will increase to 20 mg/wk.Dose will remain stable to end of study.~Sulfasalazine: Start at 500mg bid. Dose remain steady to 24-wks. If total remission not achieved and labs acceptable, dose to increase to 1000 mg bid.~Hydroxychloroquine: Started and maintain throughout study at 200mg bid Intervention will as listed above.~Methotrexate-Sulfasalazine-Hydroxychloroquine: Methotrexate:~dosing starts at 10mg/week (4 tabs/wk). If total remission (according to ACR criteria found in Appendix II) has not been achieved and the labs are acceptable at the 8-week evaluation, the dose increased to 15 mg/week (6 tabs/wk);at the 16-week evaluation, the dose increased to 20 mg/week (8 tabs/wk). This dose will remain stable until the end of the study.~Sulfasalazine: dosing will start at 5"
10903334|NCT00579878|OG002|Outcome|Leflunomide-Sulfasalazine-Hydroxychloroquine|Leflunomide-Sulfasalazine-Hydroxychloroquine: Leflunomide: dose of 100 mg (or placebo) for three (3) days. Followed by a dose of 20 mg/day will be maintained throughout the remainder of the study. dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur Sulfasalazine: dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable, dose will be increased to 1000 mg bid (2000 mg/day) Hydroxychloroquine: dosing will be started and maintained throughout the study at 200 mg bid (400 mg/day).
10903335|NCT00579878|EG000|Reported Event|1 Leflunomide Alone vs Combination Therapy|"Group A: Leflunomide alone~Leflunomide: A loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations~Leflunomide: a loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations)."
10903336|NCT00579878|EG001|Reported Event|Methotrexate-Sulfasalazine-Hydroxychloroquine|"Methotrexate: start 10mg/wk. If remission (ACR criteria) not achieved, labs acceptable at 8-wks, dose will to 15 mg/wk. If remission not achieved, labs acceptable at16-wk, increase to 20 mg/wk.Dose stable to end of study.~Sulfasalazine: Start at 500mg bid. Dose steady to 24-wks. If total remission not achieved/labs acceptable, dose to 1000mg bid.~Hydroxychloroquine: Start/maintain throughout study at 200mg bid Intervention will as listed above.~Methotrexate-Sulfasalazine-Hydroxychloroquine: Methotrexate:~starts 10mg/wk. If total remission (according to ACR criteria) not achieved labs are acceptable at 8-wks, dose increase to 15mg/wk; at 16-wks, dose increase to 20mg/wk. Dose stable until the end of study.~Sulfasalazine: start at 500mg bid. Dose steady to 24-wks. If total remission not achieved by this time and labs acceptable, dose will increase to 1000mg bid Hydroxychloroquine; started and maintained throughout the study at 200 mg bid"
10903337|NCT00579878|EG002|Reported Event|Leflunomide-Sulfasalazine-Hydroxychloroquine|Leflunomide-Sulfasalazine-Hydroxychloroquine: Leflunomide: dose of 100 mg (or placebo) for three (3) days. Followed by a dose of 20 mg/day will be maintained throughout the remainder of the study. dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur Sulfasalazine: dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable, dose will be increased to 1000 mg bid (2000 mg/day) Hydroxychloroquine: dosing will be started and maintained throughout the study at 200 mg bid (400 mg/day).
10903338|NCT00579982|BG000|Baseline|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
10903339|NCT00579982|FG000|Participant Flow|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
10903340|NCT00579982|OG000|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
10903341|NCT00579982|EG000|Reported Event|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
10914976|NCT00633594|OG000|Outcome|Phase II - Lenalidomide 10mg PO QD|Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 IV Days 1, 4, 8, and 11 for Cycles 1-6
11172091|NCT02006888|OG000|Outcome|IBI-10090 Low Dose|"IBI-10090 low dose~IBI-10090"
11172092|NCT02006888|OG001|Outcome|IBI-10090 Med Dose|"IBI-10090 med dose~IBI-10090"
11172093|NCT02006888|OG002|Outcome|Placebo|"Placebo~Placebo: Placebo"
10903342|NCT00580034|BG000|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d sc or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
10903343|NCT00580034|FG000|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously(dose will be rounded to the nearest whole vial size and may be divided into bid dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
10903344|NCT00580034|FG001|Participant Flow|Donor Apheresis|"Donor must be a sibling, half sibling, parent, child or first cousin familial relationship and 3-5/6 Human Leukocyte Antigen matched related to subject. They must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following:~Adequate cardiac function by history and physical examination~bilirubin and hepatic transaminases < 2.5 x upper limit of normal~normal hematologic parameters Females should have a negative serum pregnancy test."
10903345|NCT00580034|OG000|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
10903346|NCT00580034|EG000|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneously or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
10903347|NCT00580047|BG000|Baseline|Intravenous Bisphosphonate Post Transplantation|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually"
10903348|NCT00580047|BG001|Baseline|Oral Bisphosphonate Post Tranpslantation|"Alendronate 70mg~Alendronate: 70mg weekly"
10903349|NCT00580047|BG002|Baseline|Placebo Post Transplantation|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D"
10903350|NCT00580047|BG003|Baseline|Total|Total of all reporting groups
10903351|NCT00580047|FG000|Participant Flow|Intravenous Bisphosphonate Post Transplantation|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually"
10903352|NCT00580047|FG001|Participant Flow|Oral Bisphosphonate Post Transplantation|"Alendronate 70mg~Alendronate: 70mg weekly"
11172094|NCT02006888|EG000|Reported Event|IBI-10090 Low Dose|"IBI-10090 low dose~IBI-10090"
10903353|NCT00580047|FG002|Participant Flow|Placebo Group Post Transplantation|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D"
10903354|NCT00580047|OG000|Outcome|Intravenous Bisphosphonate Post Transplantation|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually~8% increase"
10903355|NCT00580047|OG001|Outcome|Oral Bisphosphonate Post Transplantation|"Alendronate 70mg~Alendronate: 70mg weekly~8% increase"
10903356|NCT00580047|OG002|Outcome|Placebo Group Post Transplantation|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D~8% increase"
10903357|NCT00580047|OG000|Outcome|Intravenous Bisphosphonate Post Transplantation|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually~7.9% increase in spine bone density"
10903358|NCT00580047|OG001|Outcome|Oral Bisphosphonate Post Transplantation|"Alendronate 70mg~Alendronate: 70mg weekly~5.8% increase in spine bone density"
10903359|NCT00580047|OG002|Outcome|Placebo Group Post Transplantation|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D~6.2% increase in spine bone density"
10903360|NCT00580047|EG000|Reported Event|Intravenous Bisphosphonate After Tranpslant|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually"
10903361|NCT00580047|EG001|Reported Event|Oral Bisphosphonate After Transplant|"Alendronate 70mg~Alendronate: 70mg weekly"
10903362|NCT00580047|EG002|Reported Event|Placebo After Transplant|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D"
11172095|NCT02006888|EG001|Reported Event|IBI-10090 Med Dose|"IBI-10090 med dose~IBI-10090"
11172096|NCT02006888|EG002|Reported Event|Placebo|"Placebo~Placebo: Placebo"
10903363|NCT00580073|BG000|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
10903364|NCT00580073|FG000|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU (5-fluorouracil) Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
10903365|NCT00580073|OG000|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
10903366|NCT00580073|EG000|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
10903367|NCT00580138|BG000|Baseline|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
10903368|NCT00580138|FG000|Participant Flow|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
10903369|NCT00580138|OG000|Outcome|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
10903370|NCT00580138|EG000|Reported Event|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
10903371|NCT00580151|BG000|Baseline|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
10903372|NCT00580151|BG001|Baseline|Control Group|placebo : 1 dose every 6 hours
10903373|NCT00580151|BG002|Baseline|Total|Total of all reporting groups
10903374|NCT00580151|FG000|Participant Flow|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
10903375|NCT00580151|FG001|Participant Flow|Control Group|placebo : 1 dose every 6 hours
10903376|NCT00580151|OG000|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
10903377|NCT00580151|OG001|Outcome|Control Group|placebo : 1 dose every 6 hours
10903378|NCT00580151|EG000|Reported Event|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
10903379|NCT00580151|EG001|Reported Event|Control Group|placebo : 1 dose every 6 hours
10903380|NCT00580229|BG000|Baseline|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
10903381|NCT00580229|FG000|Participant Flow|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
10903382|NCT00580229|OG000|Outcome|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
10903383|NCT00580229|EG000|Reported Event|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
10903384|NCT00580294|BG000|Baseline|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
10903385|NCT00580294|FG000|Participant Flow|Oxymorphone|participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
10903386|NCT00580294|OG000|Outcome|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
10903387|NCT00580294|EG000|Reported Event|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
10903388|NCT00580333|BG000|Baseline|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given IV on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)"
11172097|NCT02006979|BG000|Baseline|Exercise|an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
11172098|NCT02006979|BG001|Baseline|Usual Care|no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
11172099|NCT02006979|BG002|Baseline|Total|Total of all reporting groups
10903389|NCT00580333|FG000|Participant Flow|Cisplatin/Avastin|"cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)"
10903390|NCT00580333|OG000|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
10903391|NCT00580333|OG000|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
10903392|NCT00580333|EG000|Reported Event|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
10914977|NCT00633594|OG001|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
11172100|NCT02006979|FG000|Participant Flow|Exercise|"an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post~exercise: An acute bout of exercise performed 24 hours prior to every anthracycline infusion."
11172101|NCT02006979|FG001|Participant Flow|Usual Care|no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
11172102|NCT02006979|OG000|Outcome|Exercise|an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
11172103|NCT02006979|OG001|Outcome|Usual Care|no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
11172104|NCT02006979|EG000|Reported Event|Exercise|an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
11172105|NCT02006979|EG001|Reported Event|Usual Care|no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
11172106|NCT02007070|BG000|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
11172107|NCT02007070|FG000|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
11172108|NCT02007070|OG000|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
11172109|NCT02007070|EG000|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
11172110|NCT02007096|BG000|Baseline|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
11172111|NCT02007096|BG001|Baseline|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
11172112|NCT02007096|BG002|Baseline|Total|Total of all reporting groups
11172113|NCT02007096|FG000|Participant Flow|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
11172114|NCT02007096|FG001|Participant Flow|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
11172115|NCT02007096|OG000|Outcome|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
11172116|NCT02007096|OG001|Outcome|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
11172117|NCT02007096|EG000|Reported Event|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
11172118|NCT02007096|EG001|Reported Event|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
10903393|NCT00580372|BG000|Baseline|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
10903394|NCT00580372|FG000|Participant Flow|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
10903395|NCT00580372|OG000|Outcome|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
10903396|NCT00580372|EG000|Reported Event|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
10903397|NCT00580398|BG000|Baseline|Control|Usual care included physician advice to quit smoking.
10903398|NCT00580398|BG001|Baseline|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
10903399|NCT00580398|BG002|Baseline|Total|Total of all reporting groups
10903400|NCT00580398|FG000|Participant Flow|Control|Usual care included physician advice to quit smoking.
10903401|NCT00580398|FG001|Participant Flow|Intervention|Intervention participants were provided with a 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We had proposed to offer 7 counseling sessions but were flexible in offering additional sessions when needed. The counseling was delivered by a certified Tobacco Treatment Counselor using motivational interviewing (MI) techniques.
10903402|NCT00580398|OG000|Outcome|Control|Usual care included physician advice to quit smoking.
10903403|NCT00580398|OG001|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
10903404|NCT00580398|EG000|Reported Event|Control|Usual care included physician advice to quit smoking.
10903405|NCT00580398|EG001|Reported Event|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
10903406|NCT00580502|BG000|Baseline|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
10903407|NCT00580502|FG000|Participant Flow|Lap-Band|"Low BMI patients who will go through Lap-band surgery.~LAP-BAND® Adjustable Gastric Band (LAGB®): Bariatric surgery: LAGB"
10903408|NCT00580502|OG000|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
10903409|NCT00580502|EG000|Reported Event|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
10903410|NCT00580606|BG000|Baseline|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
10903411|NCT00580606|BG001|Baseline|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
10903412|NCT00580606|BG002|Baseline|Total|Total of all reporting groups
10903413|NCT00580606|FG000|Participant Flow|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
10903414|NCT00580606|FG001|Participant Flow|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
10903415|NCT00580606|OG000|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
10903416|NCT00580606|OG001|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
10903417|NCT00580606|OG000|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
10903418|NCT00580606|OG001|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
10903419|NCT00580606|OG000|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
11172119|NCT02007109|BG000|Baseline|Nausea Measurement by VAS and BARF|"All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea.~For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel. (Point to the each face at the appropriate time). Which face is more like you feel right now? For the VAS scale: On this line the far left indicates No nausea and the far right Worst nausea ever. Can you show me on this line how much nausea you have right now?"
11357456|NCT03757234|BG004|Baseline|Levofloxacin 750 iv/750 po or iv|On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
11357457|NCT03757234|BG005|Baseline|Total|Total of all reporting groups
10903420|NCT00580606|OG000|Outcome|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
10903421|NCT00580606|OG001|Outcome|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
10903422|NCT00580606|EG000|Reported Event|Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
10903423|NCT00580606|EG001|Reported Event|Placebo Before Week 44 OFC (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
10903424|NCT00580606|EG002|Reported Event|High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy
10914978|NCT00633594|OG000|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
11090987|NCT01532687|OG001|Outcome|Gemcitabine Hydrochloride Plus Placebo|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gemcitabine: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib: Given PO~Pazopanib Hydrochloride: Given PO~Placebo Administration: Given PO"
11090988|NCT01532687|OG000|Outcome|Crossover From Gemcitabine + Placebo to Gemcitabine + Open-label Pazopanib|Participants randomized to the gemcitabine + placebo arm who progressed can be moved into the crossover arm, receiving gemcitabine + open-label pazopanib
11090989|NCT01532687|EG000|Reported Event|Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gemcitabine: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib: Given PO~Pazopanib Hydrochloride: Given PO"
11090990|NCT01532687|EG001|Reported Event|Gemcitabine Hydrochloride Plus Placebo|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression, are unblinded and found randomized to placebo arm may crossover to receive open-label pazopanib hydrochloride PO daily.~AEs and deaths reported only while participant is in placebo arm/group.~Gemcitabine: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pazopanib: Given PO~Pazopanib Hydrochloride: Given PO~Placebo Administration: Given PO"
11090991|NCT01532687|EG002|Reported Event|Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib|Patients who progress and found randomized to the placebo arm after unblinding are eligible for receipt of open-label gemcitabine plus pazopanib. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. AEs and deaths collected during this treatment period
11090992|NCT01532700|BG000|Baseline|Ofatumumab With GSK2110183|"Ofatumumab with GSK2110183: - GSK2110183 125mg OD continuously~- Ofatumumab 300mg IV first dose, 2000mg weekly x 7 doses, then 2000mg monthly x 4 doses"
11090993|NCT01532700|FG000|Participant Flow|Ofatumumab With GSK2110183|"Ofatumumab with GSK2110183: - GSK2110183 125mg OD continuously~- Ofatumumab 300mg IV first dose, 2000mg weekly x 7 doses, then 2000mg monthly x 4 doses"
10903425|NCT00580606|EG003|Reported Event|Low Dose Peanut SLIT (Double Blind to Open Label)|After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
10903426|NCT00580606|EG004|Reported Event|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
10903427|NCT00580645|BG000|Baseline|Placebo|"Placebo controlled~placebo: placebo"
11090994|NCT01532700|OG000|Outcome|Ofatumumab With GSK2110183|"Ofatumumab with GSK2110183: - GSK2110183 125mg OD continuously~- Ofatumumab 300mg IV first dose, 2000mg weekly x 7 doses, then 2000mg monthly x 4 doses"
11090995|NCT01532700|EG000|Reported Event|Ofatumumab With GSK2110183|"Ofatumumab with GSK2110183: - GSK2110183 125mg OD continuously~- Ofatumumab 300mg IV first dose, 2000mg weekly x 7 doses, then 2000mg monthly x 4 doses"
11090996|NCT01532817|BG000|Baseline|Alphacore|"noninvasive neurostimulation of the vagus nerve~AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck"
11090997|NCT01532817|FG000|Participant Flow|Alphacore|"noninvasive neurostimulation of the vagus nerve~AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck"
11090998|NCT01532817|OG000|Outcome|Alphacore|"noninvasive neurostimulation of the vagus nerve~AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck"
11090999|NCT01532817|EG000|Reported Event|Alphacore|"noninvasive neurostimulation of the vagus nerve~AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck"
11091000|NCT01532830|BG000|Baseline|Active|n-VNS active therapy
11091001|NCT01532830|FG000|Participant Flow|gammaCore Device|non-invasive vagus nerve stimulator gammaCore: treatment with gammaCore vagus nerve stimulator
11091002|NCT01532830|OG000|Outcome|Active|n-VNS active therapy
11091003|NCT01532830|EG000|Reported Event|Active|n-VNS active therapy
11091004|NCT01532869|BG000|Baseline|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
11091005|NCT01532869|BG001|Baseline|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
11091006|NCT01532869|BG002|Baseline|Total|Total of all reporting groups
11091007|NCT01532869|FG000|Participant Flow|Placebo|Participants received tocilizumab (TCZ) matched placebo by subcutaneous (SC) injection every week (qw) for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 milligrams [mg]) SC injection qw in the open-label period for Week 48 to Week 96.
11091008|NCT01532869|FG001|Participant Flow|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
11091009|NCT01532869|OG000|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
11091010|NCT01532869|OG001|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
11091011|NCT01532869|OG000|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
11091012|NCT01532869|EG000|Reported Event|Placebo (up to 24 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 24 are presented in this reporting group.
11091013|NCT01532869|EG001|Reported Event|Tocilizumab (up to 24 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 24 was presented in this reporting group.
11091014|NCT01532869|EG002|Reported Event|Placebo (up to 48 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 48 are presented in this reporting group.
11091015|NCT01532869|EG003|Reported Event|Tocilizumab (up to 48 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 48 are presented in this reporting group.
11091016|NCT01532869|EG004|Reported Event|Placebo to Tocilizumab (up to 96 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for double-blind placebo to open-label tocilizumab up to Week 96 are presented in this reporting group.
11091017|NCT01532869|EG005|Reported Event|Tocilizumab to Tocilizumab (up to 96 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for double-blind tocilizumab to open-label tocilizumab up to Week 96 are presented in this reporting group.
11091018|NCT01532908|BG000|Baseline|Part 1: MBL-HCV1 and Telaprevir|"MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56~Telaprevir (Part 1): Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56"
10903428|NCT00580645|BG001|Baseline|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
10903429|NCT00580645|BG002|Baseline|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
10903430|NCT00580645|BG003|Baseline|Total|Total of all reporting groups
10903431|NCT00580645|FG000|Participant Flow|Placebo|"Placebo controlled~placebo: placebo"
10903432|NCT00580645|FG001|Participant Flow|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
10903433|NCT00580645|FG002|Participant Flow|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
10903434|NCT00580645|OG000|Outcome|Placebo|"Placebo controlled~placebo: placebo"
10903435|NCT00580645|OG001|Outcome|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
10903436|NCT00580645|OG002|Outcome|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
10903437|NCT00580645|EG000|Reported Event|Placebo|"Placebo controlled~placebo: placebo"
10903438|NCT00580645|EG001|Reported Event|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
10903439|NCT00580645|EG002|Reported Event|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
10903440|NCT00580671|BG000|Baseline|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
10903441|NCT00580671|BG001|Baseline|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
10903442|NCT00580671|BG002|Baseline|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
10903443|NCT00580671|BG003|Baseline|Total|Total of all reporting groups
10903444|NCT00580671|FG000|Participant Flow|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/ Cognitive Behavior Therapy (CBT) + Contingency Management (CM) / Behavioral Parent Training (BPT)
10903445|NCT00580671|FG001|Participant Flow|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
10903446|NCT00580671|FG002|Participant Flow|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
10903447|NCT00580671|OG000|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
10903448|NCT00580671|OG001|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
10903449|NCT00580671|OG002|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
10903450|NCT00580671|EG000|Reported Event|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
10903451|NCT00580671|EG001|Reported Event|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
10903452|NCT00580671|EG002|Reported Event|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
10903453|NCT00580723|BG000|Baseline|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
10903454|NCT00580723|FG000|Participant Flow|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
10903455|NCT00580723|OG000|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
10903456|NCT00580723|EG000|Reported Event|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
10903457|NCT00580788|BG000|Baseline|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
10903458|NCT00580788|BG001|Baseline|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
10903459|NCT00580788|BG002|Baseline|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
10903460|NCT00580788|BG003|Baseline|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
10903461|NCT00580788|BG004|Baseline|Total|Total of all reporting groups
10903462|NCT00580788|FG000|Participant Flow|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
10903463|NCT00580788|FG001|Participant Flow|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
10903464|NCT00580788|FG002|Participant Flow|Group 3|PTHrP (1-36) 5 pmol/kg/hr
10903465|NCT00580788|FG003|Participant Flow|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
10903466|NCT00580788|OG000|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
10903467|NCT00580788|OG001|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
10903468|NCT00580788|OG002|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
10903469|NCT00580788|OG003|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
10903470|NCT00580788|OG001|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
10903471|NCT00580788|OG002|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
10903472|NCT00580788|OG003|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
10903473|NCT00580788|OG000|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
10903474|NCT00580788|OG001|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
10903475|NCT00580788|OG002|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
10903476|NCT00580788|OG003|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
10903477|NCT00580788|EG000|Reported Event|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
10903478|NCT00580788|EG001|Reported Event|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
10903479|NCT00580788|EG002|Reported Event|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
10903480|NCT00580788|EG003|Reported Event|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
10903481|NCT00580801|BG000|Baseline|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
10903482|NCT00580801|BG001|Baseline|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
10903483|NCT00580801|BG002|Baseline|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
10903484|NCT00580801|BG003|Baseline|Total|Total of all reporting groups
10903485|NCT00580801|FG000|Participant Flow|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
10903486|NCT00580801|FG001|Participant Flow|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
10903487|NCT00580801|FG002|Participant Flow|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
10903488|NCT00580801|OG000|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
10903489|NCT00580801|OG001|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
10903490|NCT00580801|OG002|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
10903491|NCT00580801|EG000|Reported Event|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
10903492|NCT00580801|EG001|Reported Event|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
11174202|NCT02020278|BG000|Baseline|Tolvaptan|All participants enrolled first entered a 6-month follow-up trial that evaluated post-treatment safety after participation in a tolvaptan hyponatremia trial. Participants were then eligible to receive open-label tolvaptan if they had a clinical need as determined by the investigator and met the eligibility criteria for optional tolvaptan treatment during the 6-month follow-up period. In this trial, no participants qualified for treatment during the 6-month follow-up period. Daily dose levels would have included 3.75 mg, 7.5 mg, 15 mg, 30 mg, and 60 mg.
10903493|NCT00580801|EG002|Reported Event|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
10903494|NCT00580840|BG000|Baseline|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
10903495|NCT00580840|FG000|Participant Flow|Overall|Overall for the Run-in period includes all 333 subjects that entered the study. Overall for the Double-blind period includes all 209 subjects that completed the Run-in period.
10903496|NCT00580840|FG001|Participant Flow|CZP 400 mg and PLO + MTX|Certolizumab Pegol (CZP) 400 mg and Placebo (PLO) + Methotrexate (MTX)
10903497|NCT00580840|FG002|Participant Flow|CZP 200 mg and PLO + MTX|Certolizumab Pegol (CZP) 200 mg and Placebo (PLO) + Methotrexate (MTX)
10903498|NCT00580840|FG003|Participant Flow|PLO + MTX|Placebo (PTO) + Methotrexate (MTX)
10903499|NCT00580840|OG000|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
10903500|NCT00580840|OG001|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
10903501|NCT00580840|OG002|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
10903502|NCT00580840|OG000|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
10903503|NCT00580840|EG000|Reported Event|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
10903504|NCT00580840|EG001|Reported Event|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
10903505|NCT00580840|EG002|Reported Event|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
10903506|NCT00580840|EG003|Reported Event|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
10903507|NCT00580853|BG000|Baseline|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
10903508|NCT00580853|BG001|Baseline|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
10903509|NCT00580853|BG002|Baseline|Placebo|"Placebo Control~Placebo: Placebo"
10903510|NCT00580853|BG003|Baseline|Total|Total of all reporting groups
10903511|NCT00580853|FG000|Participant Flow|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
10903512|NCT00580853|FG001|Participant Flow|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
11172120|NCT02007109|FG000|Participant Flow|Nausea Measurement by VAS and BARF|"All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea.~For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel. (Point to the each face at the appropriate time). Which face is more like you feel right now? For the VAS scale: On this line the far left indicates No nausea and the far right Worst nausea ever. Can you show me on this line how much nausea you have right now?"
11172121|NCT02007109|OG000|Outcome|PACU Time|Subject's rated their pain and nausea while in PACU
10903513|NCT00580853|FG002|Participant Flow|Placebo|"Placebo Control~Placebo: Placebo"
10903514|NCT00580853|OG000|Outcome|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
10903515|NCT00580853|OG001|Outcome|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
10903516|NCT00580853|OG002|Outcome|Placebo|"Placebo Control~Placebo: Placebo"
10903517|NCT00580853|EG000|Reported Event|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
10903518|NCT00580853|EG001|Reported Event|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
10903519|NCT00580853|EG002|Reported Event|Placebo|"Placebo Control~Placebo: Placebo"
10903520|NCT00580866|BG000|Baseline|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
10903521|NCT00580866|BG001|Baseline|PT Only Group|
10903522|NCT00580866|BG002|Baseline|Total|Total of all reporting groups
10903523|NCT00580866|FG000|Participant Flow|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
10903524|NCT00580866|FG001|Participant Flow|PT Only Group|
10903525|NCT00580866|OG000|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
10903526|NCT00580866|OG001|Outcome|PT Only Group|
10903527|NCT00580866|EG000|Reported Event|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
10903528|NCT00580866|EG001|Reported Event|PT Only Group|
10903529|NCT00580957|BG000|Baseline|Blocked Then Intact|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
10903530|NCT00580957|BG001|Baseline|Intact Then Blocked|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
10903531|NCT00580957|BG002|Baseline|Total|Total of all reporting groups
10903532|NCT00580957|FG000|Participant Flow|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
11172122|NCT02007109|OG001|Outcome|Discharge From PACU|Subjects rated their pain and nausea upon discharge from PACU
11172123|NCT02007109|OG000|Outcome|Post-Discharge Analysis|This includes all subjects who returned their diaries.
11357458|NCT03757234|FG000|Participant Flow|Omadacycline 200 iv/200 iv|On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
10903533|NCT00580957|FG001|Participant Flow|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
10903534|NCT00580957|OG000|Outcome|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
10903535|NCT00580957|OG001|Outcome|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
10903536|NCT00580957|EG000|Reported Event|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
10903537|NCT00580957|EG001|Reported Event|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
10903538|NCT00580970|BG000|Baseline|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
10903539|NCT00580970|BG001|Baseline|Supportive Care (Lovastatin) (Ineligible)|The 20 subjects started Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy). The subjects were ineligible because they did not complete 6 months of Lovastatin.
10903540|NCT00580970|BG002|Baseline|Total|Total of all reporting groups
10903541|NCT00580970|FG000|Participant Flow|Supportive Care (Lovastatin)|"Subjects took Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued for 12 months.~73 subjects enrolled in the study, 72 started treatment, 20 subjects were ineligible for analysis, and a total of 53 evaluable subjects."
11342113|NCT03697122|OG000|Outcome|HHBC and Forced Air Warming|"Patients admitted to intensive care unit hypothermic (≤ 35 C) following surgical procedures involving cardiopulmonary bypass. Will be rewarmed with heated humidified breathing circuits (ANAPOD) and standard forced air warming blankets.~Heated Humidified Breathing Circuit and Forced Air Blanket: Heated humidified breathing circuits (ANAPOD) will be set up and managed by respiratory therapist in standard fashion defined by the manufacturer. Temperate will be set at 41C.~Forced air warming blankets will be set at 42C for duration of rewarming."
10903542|NCT00580970|OG000|Outcome|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
10903543|NCT00580970|EG000|Reported Event|Supportive Care (Lovastatin)|"Subjects who started treatment on Lovastatin on the first day of radiation therapy (external beam radiation therapy (EBRT) alone, brachytherapy alone, or EBRT followed by brachytherapy).~73 subjects enrolled in the study, 72 started Lovastatin treatment, 20 subjects were ineligible for analysis, and a total of 53 subjects evaluable for analysis. 72 subjects started treatment and were at risk for Adverse Events (AEs) and Serious Adverse Events(SAEs)."
10903544|NCT00580983|BG000|Baseline|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
10903545|NCT00580983|FG000|Participant Flow|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
10903546|NCT00580983|OG000|Outcome|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
10903547|NCT00580983|EG000|Reported Event|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
10903548|NCT00581048|BG000|Baseline|Natural Source d-α-tocopheryl Acetate|"1500 units daily for 16 weeks~Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks"
10903549|NCT00581048|FG000|Participant Flow|Natural Source d-α-tocopheryl Acetate|"1500 units daily for 16 weeks~Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks"
10903550|NCT00581048|OG000|Outcome|Before Treatment, Baseline|
10903551|NCT00581048|OG001|Outcome|After Treatment|
10903552|NCT00581048|EG000|Reported Event|Natural Source d-α-tocopheryl Acetate|"1500 units daily for 16 weeks~Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks"
10903553|NCT00581061|BG000|Baseline|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
10903554|NCT00581061|FG000|Participant Flow|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
10903555|NCT00581061|OG000|Outcome|Vesicare|Number of days it takes for subjects to achieve pad free urinary continence
10903556|NCT00581061|OG000|Outcome|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
10903557|NCT00581061|OG000|Outcome|Vesicare|Number of people who experienced side effects while taking Vesicare, per study protocol. These are known side effects indicated on the drug label that occur to subjects on this medication.
10903558|NCT00581061|EG000|Reported Event|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
10903559|NCT00581100|BG000|Baseline|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
10903560|NCT00581100|BG001|Baseline|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
10903561|NCT00581100|BG002|Baseline|Total|Total of all reporting groups
10903562|NCT00581100|FG000|Participant Flow|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
10903563|NCT00581100|FG001|Participant Flow|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
10903564|NCT00581100|OG000|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
10903565|NCT00581100|OG001|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
10903566|NCT00581100|EG000|Reported Event|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
10903567|NCT00581100|EG001|Reported Event|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
10903568|NCT00581230|BG000|Baseline|Laryngoscopy Without RAMP, Then Laryngoscopy With RAMP|First, laryngoscopy was preformed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Positioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™. Second, the Rapid Airway Management Positioner (RAMP) was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, the second time with RAMP, and the laryngeal view was recorded.
10903569|NCT00581230|FG000|Participant Flow|Entire Study|All the patients first underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope without RAMP. Second, all patients underwent laryngoscopy with RAMP--the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
10903570|NCT00581230|OG000|Outcome|Laryngoscopy Without RAMP|In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
10903571|NCT00581230|OG001|Outcome|Laryngoscopy With RAMP|In this crossover study, all participants then received laryngoscopy with the Rapid Airway Management Positioner (RAMP) (immediately after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
11342290|NCT03704194|OG001|Outcome|Adapted LiFE|"Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar."
10903572|NCT00581230|OG000|Outcome|Laryngoscopy Without RAMP|The Cormack Lehane grade view obtained with laryngoscopy when there was no RAMP pillow. In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
10903573|NCT00581230|OG001|Outcome|Laryngoscopy With RAMP|The Cormack Lehane grade glottic view obtained during laryngoscopy with inflated RAMP pillow. In all participants, laryngoscopy with the Rapid Airway Management Positioner (RAMP) was performed second (after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
10903574|NCT00581230|EG000|Reported Event|Entire Study|This is a crossover study, all the patients 1st underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope. After this, the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
10914979|NCT00633594|OG001|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
10914980|NCT00633594|OG000|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
10903575|NCT00581256|BG000|Baseline|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
10903576|NCT00581256|BG001|Baseline|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
10903577|NCT00581256|BG002|Baseline|Total|Total of all reporting groups
10903578|NCT00581256|FG000|Participant Flow|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
10903579|NCT00581256|FG001|Participant Flow|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
10903580|NCT00581256|OG000|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
10903581|NCT00581256|OG001|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
10903582|NCT00581256|EG000|Reported Event|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
10903583|NCT00581256|EG001|Reported Event|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
10903584|NCT00581308|BG000|Baseline|PAS Subjects|Subjects with occluder in place upon leaving cath lab
10903585|NCT00581308|FG000|Participant Flow|PAS Subjects|Subjects with occluder in place upon leaving cath lab
10903586|NCT00581308|OG000|Outcome|Clinical Success at 12 Months|Subjects with occluder in place upon leaving cath lab
11357459|NCT03757234|FG001|Participant Flow|Omadacycline 200 iv/100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
10903587|NCT00581308|OG000|Outcome|Clinical Success at 36 Months|Subjects with occluder in place upon leaving cath lab
10903588|NCT00581308|OG000|Outcome|Clinical Success at 60 Months|Subjects with occluder in place upon leaving cath lab
10903589|NCT00581308|OG000|Outcome|GORE® HELEX® Septal Occluder|Subjects who received a GORE® HELEX® Septal Occluder
10903590|NCT00581308|EG000|Reported Event|PAS Subjects|Subjects with occluder in place upon leaving cath lab
10903591|NCT00581347|BG000|Baseline|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
10903592|NCT00581347|BG001|Baseline|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
10903593|NCT00581347|BG002|Baseline|Total|Total of all reporting groups
10914981|NCT00633594|EG000|Reported Event|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14.
10903594|NCT00581347|FG000|Participant Flow|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
10903595|NCT00581347|FG001|Participant Flow|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
10903596|NCT00581347|OG000|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
10903597|NCT00581347|OG001|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
10903598|NCT00581347|EG000|Reported Event|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
10903599|NCT00581347|EG001|Reported Event|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
10903600|NCT00581360|BG000|Baseline|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
10903601|NCT00581360|FG000|Participant Flow|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
10903602|NCT00581360|OG000|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
10903603|NCT00581360|EG000|Reported Event|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
10903604|NCT00581386|BG000|Baseline|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
10903605|NCT00581386|BG001|Baseline|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
10903606|NCT00581386|BG002|Baseline|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
10903607|NCT00581386|BG003|Baseline|Total|Total of all reporting groups
10903608|NCT00581386|FG000|Participant Flow|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
10903609|NCT00581386|FG001|Participant Flow|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
10903610|NCT00581386|FG002|Participant Flow|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
10903611|NCT00581386|OG000|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
10903612|NCT00581386|OG001|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
10903613|NCT00581386|OG002|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
10903614|NCT00581386|EG000|Reported Event|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
10903615|NCT00581386|EG001|Reported Event|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
10903616|NCT00581386|EG002|Reported Event|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
10903617|NCT00581399|BG000|Baseline|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
10903618|NCT00581399|BG001|Baseline|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
10903619|NCT00581399|BG002|Baseline|Total|Total of all reporting groups
10903620|NCT00581399|FG000|Participant Flow|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
10903621|NCT00581399|FG001|Participant Flow|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
10903622|NCT00581399|OG000|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
10903623|NCT00581399|OG001|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
10903624|NCT00581399|EG000|Reported Event|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
10903625|NCT00581399|EG001|Reported Event|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
10903626|NCT00581529|BG000|Baseline|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
10903627|NCT00581529|FG000|Participant Flow|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
10903628|NCT00581529|OG000|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
10903629|NCT00581529|EG000|Reported Event|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
10903630|NCT00581542|BG000|Baseline|Polytrim Ophthalmic Solution|randomization to topical polytrim
10903631|NCT00581542|BG001|Baseline|Moxifloxacin Ophthalmic Solution|randomization to topical moxifloxacin
11174203|NCT02020278|FG000|Participant Flow|Tolvaptan|All participants enrolled first entered a 6-month follow-up trial that evaluated post-treatment safety after participation in a tolvaptan hyponatremia trial. Participants were then eligible to receive open-label tolvaptan if they had a clinical need as determined by the investigator and met the eligibility criteria for optional tolvaptan treatment during the 6-month follow-up period. In this trial, no participants qualified for treatment during the 6-month follow-up period. Daily dose levels would have included 3.75 milligrams (mg), 7.5 mg, 15 mg, 30 mg, and 60 mg.
10903632|NCT00581542|BG002|Baseline|Total|Total of all reporting groups
11233396|NCT02427399|EG004|Reported Event|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
10903633|NCT00581542|FG000|Participant Flow|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
10903634|NCT00581542|FG001|Participant Flow|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
10903635|NCT00581542|OG000|Outcome|Polytrim Arm|
10903636|NCT00581542|OG001|Outcome|Moxifloxacin|
10903637|NCT00581542|OG000|Outcome|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
10903638|NCT00581542|OG001|Outcome|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
10903639|NCT00581542|EG000|Reported Event|Moxifloxacin Treatment Group|
10903640|NCT00581542|EG001|Reported Event|Polytrim Treatment Group|
10903641|NCT00581555|BG000|Baseline|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
10903642|NCT00581555|BG001|Baseline|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
10903643|NCT00581555|BG002|Baseline|Total|Total of all reporting groups
10903644|NCT00581555|FG000|Participant Flow|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
10903645|NCT00581555|FG001|Participant Flow|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
10903646|NCT00581555|OG000|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
10903647|NCT00581555|OG001|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
10903648|NCT00581555|EG000|Reported Event|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
10903649|NCT00581555|EG001|Reported Event|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
10903650|NCT00581581|BG000|Baseline|Therapeutic Hypothermia|Randomized to cooling (original RCT)
10903651|NCT00581581|BG001|Baseline|Standard Care|Randomized to standard care (original RCT)
10903652|NCT00581581|BG002|Baseline|Total|Total of all reporting groups
10903653|NCT00581581|FG000|Participant Flow|Therapeutic Hypothermia|Randomized to cooling (original RCT)
10903654|NCT00581581|FG001|Participant Flow|Standard Care|Randomized to standard care (original RCT)
10903655|NCT00581581|OG000|Outcome|Therapeutic Hypothermia|Randomized to cooling (original RCT)
10903656|NCT00581581|OG001|Outcome|Standard Care|Randomized to standard care (original RCT)
10903657|NCT00581581|EG000|Reported Event|Therapeutic Hypothermia|Randomized to cooling (original RCT)
10903658|NCT00581581|EG001|Reported Event|Standard Care|Randomized to standard care (original RCT)
10903659|NCT00581776|BG000|Baseline|VCR-CVAD With Rituximab Maintenance|
10903660|NCT00581776|FG000|Participant Flow|VCR-CVAD With Rituximab Maintenance|
10903661|NCT00581776|OG000|Outcome|VCR-CVAD With Rituximab Maintenance|
10903662|NCT00581776|EG000|Reported Event|VCR-CVAD With Rituximab Maintenance|
10903663|NCT00581828|BG000|Baseline|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
10903664|NCT00581828|FG000|Participant Flow|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
10903665|NCT00581828|OG000|Outcome|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
10903666|NCT00581828|EG000|Reported Event|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
10903667|NCT00581854|BG000|Baseline|Group 1|SAEs during induction therapy
10903668|NCT00581854|FG000|Participant Flow|Rituximab|Single Arm Maintenance rituximab following induction chemoimmunotherapy
10903669|NCT00581854|OG000|Outcome|Group 1|All subjects received R-HyperCVAD induction therapy.
10903670|NCT00581854|EG000|Reported Event|Group 1|SAEs during induction therapy
10903671|NCT00581867|BG000|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and insulin first.
10903672|NCT00581867|FG000|Participant Flow|Placebo First, Then Intranasal Insulin|Participants in this group were randomized to receive placebo at the first fMRI visit and then received Intranasal Insulin at the second fMRI visit.
10903673|NCT00581867|FG001|Participant Flow|Intranasal Insulin First, Then Placebo|Participants in this group were randomized to receive Intranasal Insulin at the first fMRI visit and then received Placebo at the second fMRI visit.
10903674|NCT00581867|OG000|Outcome|Intranasal Insulin Aspart|
10903675|NCT00581867|OG001|Outcome|Placebo|
10903676|NCT00581867|EG000|Reported Event|Intranasal Insulin Aspart|Intranasal Insulin was administered in either first or second intervention period.
10903677|NCT00581867|EG001|Reported Event|Placebo|Placebo was administered in either first or second intervention period.
10903678|NCT00581893|BG000|Baseline|Cross-over Design|Subjects will be studied on two occasions, in random order. They will randomly be assigned to received either Phenytoin target dose of 5 mg/kg qhs for one month or placebo treatment for one month. After a 14 day washout period, they will receive the opposite treatment from the original.
10903679|NCT00581893|FG000|Participant Flow|Phenytoin First, Then Placebo|Subjects first received Phenytoin target dose of 5 mg/kg qhs for one month. After a 14 day washout period, they received the placebo treatment for one month.
10903680|NCT00581893|FG001|Participant Flow|Placebo First, Then Phentoin|Subjects first received Placebo for one month. After a 14 day washout period, they received Phenytoin target dose of 5 mg/kg qhs for one month.
10903681|NCT00581893|OG000|Outcome|Phenytoin|Phenytoin target dose of 5 mg/kg
10903682|NCT00581893|OG001|Outcome|Placebo|Placebo oral capsule
10903683|NCT00581893|EG000|Reported Event|Phenytoin|Phenytoin target dose of 5 mg/kg qhs
10903684|NCT00581893|EG001|Reported Event|Placebo|Placebo oral capsule
10903685|NCT00581919|BG000|Baseline|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
10903686|NCT00581919|FG000|Participant Flow|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
10903687|NCT00581919|OG000|Outcome|Bort, Dex, and Dox With ALCAR|Bort, Dex, and Dox with ALCAR: Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
10903688|NCT00581919|OG000|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
10903689|NCT00581919|EG000|Reported Event|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
10903690|NCT00581945|BG000|Baseline|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
10903691|NCT00581945|BG001|Baseline|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
10903692|NCT00581945|BG002|Baseline|Total|Total of all reporting groups
10903693|NCT00581945|FG000|Participant Flow|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
10903694|NCT00581945|FG001|Participant Flow|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
10903695|NCT00581945|OG000|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
10903696|NCT00581945|OG001|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
10903697|NCT00581945|EG000|Reported Event|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
10903698|NCT00581945|EG001|Reported Event|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
10903699|NCT00581971|BG000|Baseline|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
10903700|NCT00581971|FG000|Participant Flow|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.
10903701|NCT00581971|OG000|Outcome|Acute Toxicity|Participants that experienced Grade 3 or higher toxicity factors.
10903702|NCT00581971|OG000|Outcome|Recurrence|
10903703|NCT00581971|EG000|Reported Event|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
10903704|NCT00582010|BG000|Baseline|Inhaled Nitric Oxide|80 ppm was administered by inhalation for the duration of surgery
10903705|NCT00582010|BG001|Baseline|Placebo (Nitrogen Gas)|80 ppm was administered by inhalation for the duration of surgery
10903706|NCT00582010|BG002|Baseline|Total|Total of all reporting groups
10903707|NCT00582010|FG000|Participant Flow|1. Experimental|"iNO administration~inhaled nitric oxide : inhaled 80ppm for duration of surgery."
10903708|NCT00582010|FG001|Participant Flow|2. Placebo|"Placebo (nitrogen)~nitrogen gas : inhaled"
10903709|NCT00582010|OG000|Outcome|Inhaled Nitric Oxide|
10903710|NCT00582010|OG001|Outcome|Placebo|
10903711|NCT00582010|EG000|Reported Event|1. Experimental|"iNO administration~inhaled nitric oxide : inhaled 80ppm for duration of surgery."
11233397|NCT02427477|BG000|Baseline|Senofilcon A / Delefilcon A / Senofilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
10903712|NCT00582010|EG001|Reported Event|2. Placebo|"Placebo (nitrogen)~nitrogen gas : inhaled"
10903713|NCT00582075|BG000|Baseline|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
10903714|NCT00582075|FG000|Participant Flow|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
10903715|NCT00582075|OG000|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
10903716|NCT00582075|EG000|Reported Event|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
10903717|NCT00582114|BG000|Baseline|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
10903718|NCT00582114|BG001|Baseline|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
10903719|NCT00582114|BG002|Baseline|Total|Total of all reporting groups
10903720|NCT00582114|FG000|Participant Flow|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
10903721|NCT00582114|FG001|Participant Flow|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
10903722|NCT00582114|OG000|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
10903723|NCT00582114|OG001|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
10903724|NCT00582114|EG000|Reported Event|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
10914982|NCT00633594|EG001|Reported Event|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
11233398|NCT02427477|BG001|Baseline|Delefilcon A / Senofilcon A / Delefilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
11233399|NCT02427477|BG002|Baseline|Total|Total of all reporting groups
10903725|NCT00582114|EG001|Reported Event|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
10903726|NCT00582166|BG000|Baseline|Zevalin With Rituximab Maintenance|Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
10903727|NCT00582166|FG000|Participant Flow|Zevalin With Rituximab Maintenance|Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
10903728|NCT00582166|OG000|Outcome|Zevalin With Rituximab Maintenance|Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
10903729|NCT00582166|EG000|Reported Event|Zevalin With Rituximab Maintenance|Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
10903730|NCT00582205|BG000|Baseline|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
10903731|NCT00582205|FG000|Participant Flow|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
10903732|NCT00582205|OG000|Outcome|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
10903733|NCT00582205|EG000|Reported Event|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
10903734|NCT00582309|BG000|Baseline|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
10903735|NCT00582309|BG001|Baseline|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
10903736|NCT00582309|BG002|Baseline|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
10903737|NCT00582309|BG003|Baseline|Total|Total of all reporting groups
10903738|NCT00582309|FG000|Participant Flow|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
10903739|NCT00582309|FG001|Participant Flow|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
10903740|NCT00582309|FG002|Participant Flow|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
10903741|NCT00582309|OG000|Outcome|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
10903742|NCT00582309|OG001|Outcome|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
10903743|NCT00582309|OG002|Outcome|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
10903744|NCT00582309|EG000|Reported Event|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
10903745|NCT00582309|EG001|Reported Event|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
10903746|NCT00582309|EG002|Reported Event|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
10903747|NCT00582361|BG000|Baseline|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
10903748|NCT00582361|BG001|Baseline|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
10903749|NCT00582361|BG002|Baseline|Total|Total of all reporting groups
10903750|NCT00582361|FG000|Participant Flow|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
10903751|NCT00582361|FG001|Participant Flow|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
10903752|NCT00582361|OG000|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
10903753|NCT00582361|OG001|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
10903754|NCT00582361|EG000|Reported Event|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
10903755|NCT00582361|EG001|Reported Event|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
10903756|NCT00582400|BG000|Baseline|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
10903757|NCT00582400|FG000|Participant Flow|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
10903758|NCT00582400|OG000|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
10903759|NCT00582400|EG000|Reported Event|Arsenic Trioxide (Trisenox)|"arsenic trioxide: Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications.~The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution."
10903760|NCT00582426|BG000|Baseline|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
10903761|NCT00582426|BG001|Baseline|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
10903762|NCT00582426|BG002|Baseline|Total|Total of all reporting groups
10903763|NCT00582426|FG000|Participant Flow|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
10903764|NCT00582426|FG001|Participant Flow|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
10903765|NCT00582426|OG000|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
10903766|NCT00582426|OG001|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
10903767|NCT00582426|EG000|Reported Event|Octreotide LAR|
10903768|NCT00582426|EG001|Reported Event|Standard Treatment|
10903769|NCT00582491|BG000|Baseline|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
10903770|NCT00582491|BG001|Baseline|Placebo|Participants received a single oral placebo every morning for 16 days
10903771|NCT00582491|BG002|Baseline|Total|Total of all reporting groups
10903772|NCT00582491|FG000|Participant Flow|Modafinil 400mg|Modafinil 400mg orally everyday for 16 days
11233400|NCT02427477|FG000|Participant Flow|Senofilcon A / Delefilcon A/ Senofilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
10903773|NCT00582491|FG001|Participant Flow|Placebo|Placebo orally everyday for 16 days
10903774|NCT00582491|OG000|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
10903775|NCT00582491|OG001|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
10903776|NCT00582491|EG000|Reported Event|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
10903777|NCT00582491|EG001|Reported Event|Placebo|Participants received a single oral placebo every morning for 16 days
10903778|NCT00582517|BG000|Baseline|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
10903779|NCT00582517|BG001|Baseline|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
10903780|NCT00582517|BG002|Baseline|Total|Total of all reporting groups
10903781|NCT00582517|FG000|Participant Flow|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
10903782|NCT00582517|FG001|Participant Flow|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
10903783|NCT00582517|OG000|Outcome|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
10903784|NCT00582517|OG001|Outcome|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
10903785|NCT00582517|EG000|Reported Event|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
10903786|NCT00582517|EG001|Reported Event|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
10903787|NCT00582556|BG000|Baseline|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
10903788|NCT00582556|BG001|Baseline|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
10903789|NCT00582556|BG002|Baseline|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
10903790|NCT00582556|BG003|Baseline|Total|Total of all reporting groups
10903791|NCT00582556|FG000|Participant Flow|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
10903792|NCT00582556|FG001|Participant Flow|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
10903793|NCT00582556|FG002|Participant Flow|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
10903794|NCT00582556|OG000|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
10903795|NCT00582556|OG001|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
10903796|NCT00582556|OG002|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
10903797|NCT00582556|OG000|Outcome|Zometa Given 7 Days Prior to Beginning ADT|Gonadotropin releasing hormone (GnRH) analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
10903798|NCT00582556|EG000|Reported Event|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
10903799|NCT00582556|EG001|Reported Event|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
10903800|NCT00582556|EG002|Reported Event|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
10903801|NCT00582608|BG000|Baseline|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
10903802|NCT00582608|FG000|Participant Flow|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
10903803|NCT00582608|OG000|Outcome|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
10903804|NCT00582608|EG000|Reported Event|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
10903805|NCT00582660|BG000|Baseline|Celecoxib|400 mg BID given for 7 days before surgery
10903806|NCT00582660|BG001|Baseline|Placebo|1 tablet BID given for 7 days before surgery
11172124|NCT02007109|OG000|Outcome|Nausea Measurement by VAS and BARF|"All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea.~For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel. (Point to the each face at the appropriate time). Which face is more like you feel right now? For the VAS scale: On this line the far left indicates No nausea and the far right Worst nausea ever. Can you show me on this line how much nausea you have right now?"
10903807|NCT00582660|BG002|Baseline|Total|Total of all reporting groups
10903808|NCT00582660|FG000|Participant Flow|Celecoxib|400 mg BID given for 7 days before surgery
10903809|NCT00582660|FG001|Participant Flow|Placebo|1 tablet BID given for 7 days before surgery
10903810|NCT00582660|OG000|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
10903811|NCT00582660|OG001|Outcome|Placebo|1 tablet BID given for 7 days before surgery
10903812|NCT00582660|EG000|Reported Event|Celecoxib|400 mg BID given for 7 days before surgery
10903813|NCT00582660|EG001|Reported Event|Placebo|1 tablet BID given for 7 days before surgery
10903814|NCT00582738|BG000|Baseline|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
10903815|NCT00582738|BG001|Baseline|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
10903816|NCT00582738|BG002|Baseline|Total|Total of all reporting groups
10903817|NCT00582738|FG000|Participant Flow|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
10903818|NCT00582738|FG001|Participant Flow|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
10903819|NCT00582738|OG000|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
10903820|NCT00582738|OG001|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
10903821|NCT00582738|OG000|Outcome|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
10903822|NCT00582738|OG000|Outcome|Standard Treatment - Summary of Actitest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
10903823|NCT00582738|OG001|Outcome|Everolimus -Summary of Actitest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
10903824|NCT00582738|OG002|Outcome|Standard Treatment -Summary of Fibrotest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
10903825|NCT00582738|OG003|Outcome|Everolimus - Summary of Fibrotest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
10903826|NCT00582738|OG000|Outcome|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
10903827|NCT00582738|EG000|Reported Event|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.
10903828|NCT00582738|EG001|Reported Event|EVR (Everolimus)|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
10903829|NCT00582790|BG000|Baseline|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
10903830|NCT00582790|FG000|Participant Flow|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
10903831|NCT00582790|OG000|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
10903832|NCT00582790|OG000|Outcome|Low-dose IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
10903833|NCT00582790|EG000|Reported Event|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
10903834|NCT00582816|BG000|Baseline|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
10903835|NCT00582816|FG000|Participant Flow|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
10903836|NCT00582816|OG000|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
10914983|NCT00633594|EG002|Reported Event|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 - 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
10914984|NCT00633750|BG000|Baseline|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
10903837|NCT00582816|EG000|Reported Event|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
10903838|NCT00582894|BG000|Baseline|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
10903839|NCT00582894|FG000|Participant Flow|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
10903840|NCT00582894|OG000|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
10903841|NCT00582894|EG000|Reported Event|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
10903842|NCT00582907|BG000|Baseline|All Patients Received Both Rilonacept and Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
11172125|NCT02007109|EG000|Reported Event|Nausea Measurement by VAS and BARF|"All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea.~For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel. (Point to the each face at the appropriate time). Which face is more like you feel right now? For the VAS scale: On this line the far left indicates No nausea and the far right Worst nausea ever. Can you show me on this line how much nausea you have right now?"
11172126|NCT02007200|BG000|Baseline|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
11172127|NCT02007200|FG000|Participant Flow|Treatment (Soy Isoflavones)|"Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.~55 patients were enrolled. 3 of these patients did not receive treatment."
11172128|NCT02007200|OG000|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
10903843|NCT00582907|FG000|Participant Flow|Rilonacept-Placebo-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
10903844|NCT00582907|FG001|Participant Flow|Rilonacept-Placebo-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
10903845|NCT00582907|FG002|Participant Flow|Placebo-Rilonacept-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
10903846|NCT00582907|FG003|Participant Flow|Placebo-Rilonacept-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
10914985|NCT00633750|FG000|Participant Flow|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
10914986|NCT00633750|OG000|Outcome|Tarceva|Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
11172129|NCT02007200|EG000|Reported Event|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
11172130|NCT02007252|BG000|Baseline|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
11172131|NCT02007252|BG001|Baseline|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
11172132|NCT02007252|BG002|Baseline|Total|Total of all reporting groups
11172133|NCT02007252|FG000|Participant Flow|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
11172134|NCT02007252|FG001|Participant Flow|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
11172135|NCT02007252|OG000|Outcome|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
11172136|NCT02007252|OG001|Outcome|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
11172137|NCT02007252|EG000|Reported Event|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
10903847|NCT00582907|OG000|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
10903848|NCT00582907|OG001|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
10903849|NCT00582907|EG000|Reported Event|Placebo|"Adverse events during placebo treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
10903850|NCT00582907|EG001|Reported Event|Rilonacept|"Adverse events during rilonacept treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
10903851|NCT00582933|BG000|Baseline|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
10903852|NCT00582933|FG000|Participant Flow|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
10903853|NCT00582933|OG000|Outcome|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
10903854|NCT00582933|EG000|Reported Event|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
10903855|NCT00582946|BG000|Baseline|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
10903856|NCT00582946|FG000|Participant Flow|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
10903857|NCT00582946|OG000|Outcome|Maximum Equivalent Pressure Output|Provision of amplification to treat sensorineural hearing loss with direct-drive hearing aid for acute evaluation of efficacy.
10903858|NCT00582946|EG000|Reported Event|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
10903859|NCT00582972|BG000|Baseline|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
10903860|NCT00582972|FG000|Participant Flow|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
10903861|NCT00582972|OG000|Outcome|Experimental|omeprazole 40 mg daily for 30 days
10903862|NCT00582972|OG000|Outcome|Experimental|Subjects received omeprazole 40 mg daily for 30 days
11172138|NCT02007252|EG001|Reported Event|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
10903863|NCT00582972|EG000|Reported Event|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
10903864|NCT00582998|BG000|Baseline|Standard Wound Dressing|"Standard post-operative wound dressing~Standard Wound Dressing: Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact."
11172139|NCT02007278|BG000|Baseline|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
11172140|NCT02007278|BG001|Baseline|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
11172141|NCT02007278|BG002|Baseline|Total|Total of all reporting groups
10903865|NCT00582998|BG001|Baseline|Vacuum Assisted Closure Device|"Vacuum Assisted Closure (VAC) device~VAC: Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact."
10903866|NCT00582998|BG002|Baseline|Total|Total of all reporting groups
10903867|NCT00582998|FG000|Participant Flow|Standard Wound Dressing|"Standard post-operative wound dressing~Standard Wound Dressing: Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact."
10903868|NCT00582998|FG001|Participant Flow|Vacuum Assisted Closure Device|"Vacuum Assisted Closure (VAC) device~VAC: Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact."
10903869|NCT00582998|OG000|Outcome|Standard Wound Dressing|"Standard post-operative wound dressing~Standard Wound Dressing: Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact."
10903870|NCT00582998|OG001|Outcome|Vacuum Assisted Closure Device|"Vacuum Assisted Closure (VAC) device~VAC: Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact."
10903871|NCT00582998|EG000|Reported Event|Standard Wound Dressing|"Standard post-operative wound dressing~Standard Wound Dressing: Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact."
10903872|NCT00582998|EG001|Reported Event|Vacuum Assisted Closure Device|"Vacuum Assisted Closure (VAC) device~VAC: Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact."
10903873|NCT00583011|BG000|Baseline|Lidocaine|Lidocaine group 2cc of 1% lidocaine
10903874|NCT00583011|BG001|Baseline|Placebo|Normal saline group 2cc of normal saline
11172142|NCT02007278|FG000|Participant Flow|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
11172143|NCT02007278|FG001|Participant Flow|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
11172144|NCT02007278|OG000|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
11172145|NCT02007278|OG001|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
11172146|NCT02007278|EG000|Reported Event|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
11172147|NCT02007278|EG001|Reported Event|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
10903875|NCT00583011|BG002|Baseline|Total|Total of all reporting groups
10903876|NCT00583011|FG000|Participant Flow|Lidocaine|"Local anesthesia group~Local anesthesia - lidocaine: Local anesthesia: 2 cc of 1% Lidocaine"
10903877|NCT00583011|FG001|Participant Flow|Placebo|"Placebo normal saline group~Placebo Group: Placebo Group: 2cc Normal Saline"
10903878|NCT00583011|OG000|Outcome|Lidocaine|Lidocaine 2cc of 1% lidocaine group
10903879|NCT00583011|OG001|Outcome|Placebo|2cc of Normal Saline group
10903880|NCT00583011|OG001|Outcome|Placebo|2 cc of Normal saline group
10903881|NCT00583011|EG000|Reported Event|Lidocaine|Lidocaine 2cc of 1% lidocaine group
10903882|NCT00583011|EG001|Reported Event|Placebo|2cc of Normal saline group
10903883|NCT00583050|BG000|Baseline|Endovascular Aneurysm Repair|Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
10903884|NCT00583050|FG000|Participant Flow|Endovascular Aneurysm Repair|Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
10903885|NCT00583050|OG000|Outcome|Endovascular Aneurysm Repair|Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
10903886|NCT00583050|EG000|Reported Event|Endovascular Aneurysm Repair|Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
10903887|NCT00583102|BG000|Baseline|Lovastatin Followed by Cytarabine|"The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.~Cytarabine: Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.~Lovastatin: Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day."
10914987|NCT00633750|OG000|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
10903888|NCT00583102|FG000|Participant Flow|Lovastatin Followed by Cytarabine|"The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.~Cytarabine: Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.~Lovastatin: Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day."
10903889|NCT00583102|OG000|Outcome|Lovastatin Followed by Cytarabine|"The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.~Cytarabine: Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.~Lovastatin: Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day."
10903890|NCT00583102|EG000|Reported Event|Lovastatin Followed by Cytarabine|"The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.~Lovastatin and Cytarabine: Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.~Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day."
10903891|NCT00583219|BG000|Baseline|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
10903892|NCT00583219|FG000|Participant Flow|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
10903893|NCT00583219|OG000|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
10903894|NCT00583219|EG000|Reported Event|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
10903895|NCT00583362|BG000|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
10914988|NCT00633750|OG000|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants have their blood drawn and then undergo surgical resection of their tumor.
11172148|NCT02007291|BG000|Baseline|Patients Taking Cholinesterase Inhibitors|The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
10903896|NCT00583362|FG000|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
10903897|NCT00583362|OG000|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
10903898|NCT00583362|EG000|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
10903899|NCT00583375|BG000|Baseline|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
10903900|NCT00583375|BG001|Baseline|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
10903901|NCT00583375|BG002|Baseline|Total|Total of all reporting groups
10903902|NCT00583375|FG000|Participant Flow|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
10903903|NCT00583375|FG001|Participant Flow|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
10903904|NCT00583375|OG000|Outcome|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
10903905|NCT00583375|OG001|Outcome|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
10903906|NCT00583375|EG000|Reported Event|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
10903907|NCT00583375|EG001|Reported Event|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
10903908|NCT00583414|BG000|Baseline|Endovascular Aneurysm Repair|"Investigational stent-graft implant to exclude aneurysm~Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm"
10903909|NCT00583414|FG000|Participant Flow|Endovascular Aneurysm Repair|"Investigational stent-graft implant to exclude aneurysm~Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm"
10903910|NCT00583414|OG000|Outcome|Endovascular Aneurysm Repair|"Investigational stent-graft implant to exclude aneurysm~Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm"
10903911|NCT00583414|EG000|Reported Event|Endovascular Aneurysm Repair|"Investigational stent-graft implant to exclude aneurysm~Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm"
10903912|NCT00583453|BG000|Baseline|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903913|NCT00583453|BG001|Baseline|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903914|NCT00583453|BG002|Baseline|Total|Total of all reporting groups
10903915|NCT00583453|FG000|Participant Flow|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903916|NCT00583453|FG001|Participant Flow|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903917|NCT00583453|OG000|Outcome|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903918|NCT00583453|OG001|Outcome|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903919|NCT00583453|OG000|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903920|NCT00583453|OG001|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903921|NCT00583453|EG000|Reported Event|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903922|NCT00583453|EG001|Reported Event|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
10903923|NCT00583492|BG000|Baseline|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
10903924|NCT00583492|BG001|Baseline|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
10903925|NCT00583492|BG002|Baseline|Total|Total of all reporting groups
10903926|NCT00583492|FG000|Participant Flow|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
10903927|NCT00583492|FG001|Participant Flow|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
10903928|NCT00583492|OG000|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
10903929|NCT00583492|OG001|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
10903930|NCT00583492|EG000|Reported Event|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10^12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
10903931|NCT00583492|EG001|Reported Event|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
10903932|NCT00583557|BG000|Baseline|Belimumab 10 mg/kg|
10903933|NCT00583557|FG000|Participant Flow|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
10903934|NCT00583557|OG000|Outcome|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
10903935|NCT00583557|EG000|Reported Event|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
10903936|NCT00583596|BG000|Baseline|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
10903937|NCT00583596|FG000|Participant Flow|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
10903938|NCT00583596|OG000|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects implanted with Amplatzer duct occluder that have final follow-up taking place 5 yrs., 6 yrs., or 7 yrs., post implant.
10903939|NCT00583596|OG000|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
11172149|NCT02007291|FG000|Participant Flow|CDR1 Patients Taking Cholinesterase Inhibitors|The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
11233401|NCT02427477|FG001|Participant Flow|Delefilcon A / Senofilcon A / Delefilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore delefilcon A contact lens, then wore the senofilcon A second and then wore the delefilcon A contact lens third.
11233402|NCT02427477|OG000|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
10903940|NCT00583596|EG000|Reported Event|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
10903941|NCT00583622|BG000|Baseline|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
10903942|NCT00583622|FG000|Participant Flow|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
10903943|NCT00583622|OG000|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
10903944|NCT00583622|EG000|Reported Event|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
10903945|NCT00583661|BG000|Baseline|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
10903946|NCT00583661|FG000|Participant Flow|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
10903947|NCT00583661|OG000|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
10903948|NCT00583661|OG001|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
10903949|NCT00583661|EG000|Reported Event|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
10903950|NCT00583700|BG000|Baseline|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
10903951|NCT00583700|BG001|Baseline|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
10903952|NCT00583700|BG002|Baseline|Total|Total of all reporting groups
10903953|NCT00583700|FG000|Participant Flow|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
10903954|NCT00583700|FG001|Participant Flow|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
10903955|NCT00583700|OG000|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
10903956|NCT00583700|OG001|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
10903957|NCT00583700|EG000|Reported Event|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
10903958|NCT00583700|EG001|Reported Event|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
10903959|NCT00583713|BG000|Baseline|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
10903960|NCT00583713|BG001|Baseline|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
10903961|NCT00583713|BG002|Baseline|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
10903962|NCT00583713|BG003|Baseline|Total|Total of all reporting groups
10903963|NCT00583713|FG000|Participant Flow|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
10903964|NCT00583713|FG001|Participant Flow|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
10903965|NCT00583713|FG002|Participant Flow|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
10903966|NCT00583713|OG000|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
10903967|NCT00583713|OG001|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
10903968|NCT00583713|OG002|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
10903969|NCT00583713|EG000|Reported Event|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
10903970|NCT00583713|EG001|Reported Event|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
10903971|NCT00583713|EG002|Reported Event|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
10903972|NCT00583791|BG000|Baseline|Main Cohort|Patients with muscular VSDs that are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
10903973|NCT00583791|FG000|Participant Flow|Main Cohort|Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
10903974|NCT00583791|OG000|Outcome|Main Cohort|Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects
10903975|NCT00583791|EG000|Reported Event|Main Cohort|Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
10903976|NCT00583908|BG000|Baseline|Overall Study Population|Summary for overall study population
10903977|NCT00583908|FG000|Participant Flow|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903978|NCT00583908|FG001|Participant Flow|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903979|NCT00583908|FG002|Participant Flow|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903980|NCT00583908|FG003|Participant Flow|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903981|NCT00583908|FG004|Participant Flow|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903982|NCT00583908|FG005|Participant Flow|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903983|NCT00583908|FG006|Participant Flow|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903984|NCT00583908|FG007|Participant Flow|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903985|NCT00583908|FG008|Participant Flow|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903986|NCT00583908|FG009|Participant Flow|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903987|NCT00583908|FG010|Participant Flow|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903988|NCT00583908|FG011|Participant Flow|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903989|NCT00583908|OG000|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
10903990|NCT00583908|OG001|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
10903991|NCT00583908|OG002|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
10903992|NCT00583908|OG003|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
10903993|NCT00583908|EG000|Reported Event|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903994|NCT00583908|EG001|Reported Event|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903995|NCT00583908|EG002|Reported Event|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903996|NCT00583908|EG003|Reported Event|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903997|NCT00583908|EG004|Reported Event|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903998|NCT00583908|EG005|Reported Event|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10903999|NCT00583908|EG006|Reported Event|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10904000|NCT00583908|EG007|Reported Event|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10904001|NCT00583908|EG008|Reported Event|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
11233403|NCT02427477|OG001|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
10904002|NCT00583908|EG009|Reported Event|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10904003|NCT00583908|EG010|Reported Event|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10904004|NCT00583908|EG011|Reported Event|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
10904005|NCT00583947|BG000|Baseline|ARF/LEV|"Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization.~Open label: 7 day washout; arformoterol 15 microgram per nebulization."
10904006|NCT00583947|BG001|Baseline|LEV/ARF|"Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization.~Open label: 7 day washout; arformoterol 15 microgram per nebulization."
10904007|NCT00583947|BG002|Baseline|Total|Total of all reporting groups
10904008|NCT00583947|FG000|Participant Flow|ARF/LEV|"Cross-over period: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.~Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
10904009|NCT00583947|FG001|Participant Flow|LEV/ARF|"Cross-over period: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.~Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
10904010|NCT00583947|OG000|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
10904011|NCT00583947|OG001|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
10904012|NCT00583947|OG002|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
10904013|NCT00583947|EG000|Reported Event|Levalbuterol 0.63 mg|The experience of participants when treated with levalbuterol during the cross-over portion of the study.
10904014|NCT00583947|EG001|Reported Event|Arformoterol 7.5 Mcg|The experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study.
10904015|NCT00583947|EG002|Reported Event|Arformoterol 15 Mcg|The experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study.
10904016|NCT00584077|BG000|Baseline|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
10904017|NCT00584077|FG000|Participant Flow|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
10904018|NCT00584077|OG000|Outcome|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
10904019|NCT00584077|OG000|Outcome|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response. Subjects underwent bronchoscopy to elicit cough 1.5 months and 12 months after lung transplantation.
10904020|NCT00584077|EG000|Reported Event|Lung Transplant Recipients With Stable Lung Function|Enrolled subjects underwent bronchoscopy to assess for presence of cough reflex in the transpalnted and non-transplanted lung
10914989|NCT00633750|EG000|Reported Event|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
10914990|NCT00633867|BG000|Baseline|McGrath|Tracheal Intubation using McGrath video-laryngoscope
10914991|NCT00633867|BG001|Baseline|Macintosh|Tracheal intubation using Macintosh Laryngoscope
10914992|NCT00633867|BG002|Baseline|Total|Total of all reporting groups
10914993|NCT00633867|FG000|Participant Flow|McGrath|Tracheal Intubation using McGrath video-laryngoscope
10914994|NCT00633867|FG001|Participant Flow|Macintosh|Tracheal intubation using Macintosh Laryngoscope
10904021|NCT00584194|BG000|Baseline|TSI-GSD 200 RVF Vaccine|"Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.~TSI-GSD 200 RVF Vaccine: Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40."
10904022|NCT00584194|FG000|Participant Flow|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
10904023|NCT00584194|OG000|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
10904024|NCT00584194|EG000|Reported Event|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
10904025|NCT00584220|BG000|Baseline|All Subjects|Subjects who enrolled and completed the study.
10904026|NCT00584220|FG000|Participant Flow|Senofilcon A / Alphafilcon A|senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second
10904027|NCT00584220|FG001|Participant Flow|Alphafilcon A / Senofilcon A|alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second
10904028|NCT00584220|OG000|Outcome|Senofilcon A Toric|contact lenses
10904029|NCT00584220|OG001|Outcome|Alphafilcon A Toric|contact lenses
10904030|NCT00584220|EG000|Reported Event|Senofilcon A|senofilcon A toric silicone hydrogel contact lenses worn
10904031|NCT00584220|EG001|Reported Event|Alphafilcon A|alphafilcon A toric hydrogel contact lenses worn
10904032|NCT00584285|BG000|Baseline|Corneal Topographer Flourscein Patterns|"Use corneal topography to evaluate fluorescein patter of rgp contact lens~Comparison of fluorescein patterns: Compare trial contact lens fitting to fitting contact lenses based on corneal topography measurement"
10904033|NCT00584285|FG000|Participant Flow|Corneal Topographer Flourscein Patterns|"Use corneal topography to evaluate fluorescein pattern of rgp contact lens~Comparison of fluorescein patterns: Compare trial contact lens fitting to fitting contact lenses based on corneal topography measurement"
10904034|NCT00584285|OG000|Outcome|Corneal Topographer Flourscein Patterns|"Use corneal topography to evaluate fluorescein pattern of rgp contact lens~Comparison of fluorescein patterns: Compare conventional contact lens fitting to fitting contact lenses based on corneal topography measurement"
10904035|NCT00584285|EG000|Reported Event|Corneal Topographer Flourscein Patterns|"Use corneal topography to evaluate fluorescein pattern of rgp contact lens~Comparison of fluorescein patterns: Compare trial lens contact lens fitting to fitting contact lenses based on corneal topography measurement"
10904036|NCT00584402|BG000|Baseline|Contrast Sonography|Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
10904037|NCT00584402|FG000|Participant Flow|Contrast Sonography|"Contrast-enhanced sonography~perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity"
10904038|NCT00584402|OG000|Outcome|Contrast Sonography|Subjects undergoing contrast sonography
10904039|NCT00584402|EG000|Reported Event|Contrast Sonography|"Contrast-enhanced sonography~perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity"
10904040|NCT00584415|BG000|Baseline|PV Isolation + GP Ablation|All patients received pulmonary vein antrum isolation (PV isolation) and ablation of the major atrial ganglionated plexi (superior left GP, inferior left GP, anterior right GP and inferior right GP). Ganglionated plexi (GP) were identified by delivering high-frequency stimulation (20 Hz) from the ablation catheter. If vagal response (AV block) was initiated by stimulation, that site was counted as a GP site and was then ablated.
10904041|NCT00584415|FG000|Participant Flow|GP Ablation + PV Isolation|All patients in this study received pulmonary vein isolation (PVI) and ganglionated plexi (GP) ablation to treat paroxysmal AF
10904042|NCT00584415|OG000|Outcome|GP Ablation + PV Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
10904043|NCT00584415|OG000|Outcome|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
10904044|NCT00584415|EG000|Reported Event|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
10914995|NCT00633867|OG000|Outcome|McGrath|Tracheal Intubation using McGrath video-laryngoscope
10914996|NCT00633867|OG001|Outcome|Macintosh|Tracheal intubation using Macintosh Laryngoscope
10914997|NCT00633867|EG000|Reported Event|McGrath|Tracheal Intubation using McGrath video-laryngoscope
10914998|NCT00633867|EG001|Reported Event|Macintosh|Tracheal intubation using Macintosh Laryngoscope
10904045|NCT00584454|BG000|Baseline|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
10904046|NCT00584454|FG000|Participant Flow|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
10904047|NCT00584454|OG000|Outcome|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
10904048|NCT00584454|EG000|Reported Event|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
10904049|NCT00584480|BG000|Baseline|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
10904050|NCT00584480|FG000|Participant Flow|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
10904051|NCT00584480|OG000|Outcome|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
10904052|NCT00584480|EG000|Reported Event|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
11172150|NCT02007291|FG001|Participant Flow|CDR2 Patients Taking Cholinesterase Inhibitors|The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
11172151|NCT02007291|OG000|Outcome|CDR 1 Patients Taking Cholinesterase Inhibitors|The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
11172152|NCT02007291|OG001|Outcome|CDR 2 Patients Taking Cholinesterase Inhibitors|The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
11172153|NCT02007291|EG000|Reported Event|CDR1 Patients Taking Cholinesterase Inhibitors|The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
10904053|NCT00584558|BG000|Baseline|Observational Arm|All patients studied
10904054|NCT00584558|FG000|Participant Flow|1-Catheter Ablation|There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
10904055|NCT00584558|OG000|Outcome|1-Catheter Ablation|There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
10904056|NCT00584558|OG000|Outcome|1-Observational|There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
10904057|NCT00584558|EG000|Reported Event|Observational Arm|"Patients undergoing catheter ablation.~Catheter Ablation: Catheter Ablation of arrhythmias"
10904058|NCT00584701|BG000|Baseline|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
10904059|NCT00584701|FG000|Participant Flow|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
10904060|NCT00584701|OG000|Outcome|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
10904061|NCT00584701|OG000|Outcome|Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
10904062|NCT00584701|EG000|Reported Event|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
10904063|NCT00584727|BG000|Baseline|Completed Population|Only participants that completed the study are included (n=88)
10904064|NCT00584727|FG000|Participant Flow|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
10904065|NCT00584727|FG001|Participant Flow|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
10904066|NCT00584727|FG002|Participant Flow|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
10904067|NCT00584727|FG003|Participant Flow|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
10904068|NCT00584727|FG004|Participant Flow|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
10904069|NCT00584727|FG005|Participant Flow|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
10904070|NCT00584727|OG000|Outcome|Senofilcon A Toric|
10904071|NCT00584727|OG001|Outcome|Alphafilcon A Toric|
10904072|NCT00584727|OG002|Outcome|Etafilcon A Sphere|
10904073|NCT00584727|EG000|Reported Event|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
10904074|NCT00584727|EG001|Reported Event|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
10904075|NCT00584727|EG002|Reported Event|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
10904076|NCT00584727|EG003|Reported Event|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
10904077|NCT00584727|EG004|Reported Event|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
11233404|NCT02427477|EG000|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
10904078|NCT00584727|EG005|Reported Event|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
10904079|NCT00584740|BG000|Baseline|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
10904080|NCT00584740|BG001|Baseline|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
10904081|NCT00584740|BG002|Baseline|Total|Total of all reporting groups
10904082|NCT00584740|FG000|Participant Flow|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
10904083|NCT00584740|FG001|Participant Flow|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
10904084|NCT00584740|OG000|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
10904085|NCT00584740|OG001|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
10904086|NCT00584740|EG000|Reported Event|AIN457 Twice 10mg/kg|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
11233405|NCT02427477|EG001|Reported Event|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
11172154|NCT02007291|EG001|Reported Event|CDR2 Patients Taking Cholinesterase Inhibitors|The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
11172155|NCT02007369|BG000|Baseline|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
11172156|NCT02007369|BG001|Baseline|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
11172157|NCT02007369|BG002|Baseline|Control|No intervention
11172158|NCT02007369|BG003|Baseline|Total|Total of all reporting groups
10904087|NCT00584740|EG001|Reported Event|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
10904088|NCT00584805|BG000|Baseline|Vaccination|"Inactivated, Dried, TSI-GSD 104, EEE~Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period."
10904089|NCT00584805|FG000|Participant Flow|Vaccination|"Inactivated, Dried, TSI-GSD 104, EEE~Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period."
10904090|NCT00584805|OG000|Outcome|Vaccination|"Inactivated, Dried, TSI-GSD 104, EEE~Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period."
10904091|NCT00584805|OG000|Outcome|Vaccination - Primary|Inactivated, Dried, TSI-GSD 104, EEE
11172159|NCT02007369|FG000|Participant Flow|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
11172160|NCT02007369|FG001|Participant Flow|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
11172161|NCT02007369|FG002|Participant Flow|Control|No intervention
10904092|NCT00584805|OG001|Outcome|Vaccination - Booster|Inactivated, Dried, TSI-GSD 104, EEE
10904093|NCT00584805|EG000|Reported Event|Vaccination/Booster|"Inactivated, Dried, TSI-GSD 104, EEE~Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period."
10904094|NCT00584831|BG000|Baseline|Total Study Population|
10904095|NCT00584831|FG000|Participant Flow|Group1 LSOB|lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric
10904096|NCT00584831|FG001|Participant Flow|Group 2 LSBO|lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
10904097|NCT00584831|FG002|Participant Flow|Group 4 LBSO|lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
10904098|NCT00584831|FG003|Participant Flow|Group 5 LBOS|lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
10904099|NCT00584831|FG004|Participant Flow|Group 7 SLBO|senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
10904100|NCT00584831|FG005|Participant Flow|Group 8 SOLB|senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
11172162|NCT02007369|OG000|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
10904101|NCT00584831|FG006|Participant Flow|Group 9 SBLO|senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
10904102|NCT00584831|FG007|Participant Flow|Group 10 SBOL|senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
10904103|NCT00584831|FG008|Participant Flow|Group 11 OSLB|omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
10904104|NCT00584831|FG009|Participant Flow|Group 12 OSBL|omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
10904105|NCT00584831|FG010|Participant Flow|Group 13 OBLS|omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
10904106|NCT00584831|FG011|Participant Flow|Group 14 OBSL|omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
10904107|NCT00584831|FG012|Participant Flow|Group 15 BLSO|balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
10904108|NCT00584831|FG013|Participant Flow|Group 16 BLOS|balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
10904109|NCT00584831|FG014|Participant Flow|Group 18 BOLS|balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
10904110|NCT00584831|FG015|Participant Flow|Group 19 BOSL|balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
10904111|NCT00584831|FG016|Participant Flow|Group 3 LOSB|lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
10904112|NCT00584831|FG017|Participant Flow|Group 6 SLOB|senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric
10904113|NCT00584831|FG018|Participant Flow|Group 17 BSOL|balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric
10904114|NCT00584831|OG000|Outcome|Lotrafilcon B|lotrafilcon b toric
10904115|NCT00584831|OG001|Outcome|Senofilcon A|senofilcon A toric
10904116|NCT00584831|OG002|Outcome|Omafilcon A|omafilcon A toric
10904117|NCT00584831|OG003|Outcome|Balafilcon A|balafilcon A toric
10904118|NCT00584831|EG000|Reported Event|Lotrafilcon B|lotrafilcon b toric contact lens
10904119|NCT00584831|EG001|Reported Event|Senofilcon A|senofilcon A toric contact lens
10904120|NCT00584831|EG002|Reported Event|Omafilcon A|omafilcon A toric contact lens
10904121|NCT00584831|EG003|Reported Event|Balafilcon A|balafilcon A toric contact lens
10904122|NCT00584844|BG000|Baseline|F Tularensis Vaccine (0.0025 mL)|"Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.~Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20)."
10904123|NCT00584844|FG000|Participant Flow|F Tularensis Vaccine (0.0025 mL)|"Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.~Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20)."
10904124|NCT00584844|OG000|Outcome|Males|All males in study
10904125|NCT00584844|OG001|Outcome|Females|All females in study
10904126|NCT00584844|OG000|Outcome|Percent of Subjects|Percentage of subjects in specific category
10904127|NCT00584844|EG000|Reported Event|Mild|Mild
10904128|NCT00584844|EG001|Reported Event|Moderate|Moderate
10904129|NCT00584844|EG002|Reported Event|Severe|Severe
10904130|NCT00584857|BG000|Baseline|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
10904131|NCT00584857|FG000|Participant Flow|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
10904132|NCT00584857|OG000|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
10904133|NCT00584857|EG000|Reported Event|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
10904134|NCT00584870|BG000|Baseline|Tanezumab|Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
10904135|NCT00584870|BG001|Baseline|Naproxen|Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.
10904136|NCT00584870|BG002|Baseline|Placebo|Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
10904137|NCT00584870|BG003|Baseline|Total|Total of all reporting groups
10904138|NCT00584870|FG000|Participant Flow|Tanezumab|Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
10904139|NCT00584870|FG001|Participant Flow|Naproxen|Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.
10904140|NCT00584870|FG002|Participant Flow|Placebo|Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
10904141|NCT00584870|OG000|Outcome|Tanezumab|Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
10904142|NCT00584870|OG001|Outcome|Naproxen|Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.
10904143|NCT00584870|OG002|Outcome|Placebo|Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
10904144|NCT00584870|EG000|Reported Event|Tanezumab|Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
10904145|NCT00584870|EG001|Reported Event|Naproxen|Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.
10904146|NCT00584870|EG002|Reported Event|Placebo|Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
10904147|NCT00584909|BG000|Baseline|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
11172163|NCT02007369|OG001|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
10904148|NCT00584909|FG000|Participant Flow|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
10904149|NCT00584909|OG000|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
10904150|NCT00584909|EG000|Reported Event|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
10904151|NCT00584922|BG000|Baseline|AF Ablation Group|"Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.~Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks."
10904152|NCT00584922|FG000|Participant Flow|AF Ablation Group|"Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.~Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks."
10904153|NCT00584922|OG000|Outcome|AF Ablation Group|"Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.~Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks."
10904154|NCT00584922|EG000|Reported Event|AF Ablation Group|"Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.~Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks."
10904155|NCT00584948|BG000|Baseline|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
10904156|NCT00584948|BG001|Baseline|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
10904157|NCT00584948|BG002|Baseline|Total|Total of all reporting groups
10904158|NCT00584948|FG000|Participant Flow|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
10904159|NCT00584948|FG001|Participant Flow|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
10904160|NCT00584948|OG000|Outcome|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
10904161|NCT00584948|OG001|Outcome|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
11172164|NCT02007369|OG002|Outcome|Control|No intervention
10904162|NCT00584948|EG000|Reported Event|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
10904163|NCT00584948|EG001|Reported Event|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
10904164|NCT00584987|BG000|Baseline|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904165|NCT00584987|BG001|Baseline|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904166|NCT00584987|BG002|Baseline|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904167|NCT00584987|BG003|Baseline|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904168|NCT00584987|BG004|Baseline|Total|Total of all reporting groups
10904169|NCT00584987|FG000|Participant Flow|PL FF + PL OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904170|NCT00584987|FG001|Participant Flow|FF + PL OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904171|NCT00584987|FG002|Participant Flow|PL FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904172|NCT00584987|FG003|Participant Flow|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904173|NCT00584987|OG000|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904174|NCT00584987|OG001|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904175|NCT00584987|OG002|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904176|NCT00584987|OG003|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904177|NCT00584987|EG000|Reported Event|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904178|NCT00584987|EG001|Reported Event|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904179|NCT00584987|EG002|Reported Event|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904180|NCT00584987|EG003|Reported Event|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
10904181|NCT00585013|BG000|Baseline|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
10904182|NCT00585013|BG001|Baseline|2 Placebo|Placebo delivery of oxygen at standard dose.
10904183|NCT00585013|BG002|Baseline|Total|Total of all reporting groups
10904184|NCT00585013|FG000|Participant Flow|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
10904185|NCT00585013|FG001|Participant Flow|2 Placebo|Placebo delivery of oxygen at standard dose.
10904186|NCT00585013|OG000|Outcome|Nitric Oxide Delivery Group|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
10904187|NCT00585013|OG001|Outcome|Placebo|Placebo delivery of oxygen at standard dose.
10904188|NCT00585013|OG000|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
10904189|NCT00585013|OG001|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
10904190|NCT00585013|EG000|Reported Event|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
10904191|NCT00585013|EG001|Reported Event|2 Placebo|Placebo delivery of oxygen at standard dose.
10904192|NCT00585039|BG000|Baseline|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
10904193|NCT00585039|BG001|Baseline|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
10904194|NCT00585039|BG002|Baseline|Total|Total of all reporting groups
10904195|NCT00585039|FG000|Participant Flow|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
10904196|NCT00585039|FG001|Participant Flow|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
10904197|NCT00585039|OG000|Outcome|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
10904198|NCT00585039|OG001|Outcome|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
10904199|NCT00585039|OG000|Outcome|Levalbuterol|
10904200|NCT00585039|OG001|Outcome|Albuterol|
10904201|NCT00585039|EG000|Reported Event|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
10904202|NCT00585039|EG001|Reported Event|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
11233406|NCT02427607|BG000|Baseline|Perampanel|Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day.
11233407|NCT02427607|FG000|Participant Flow|Perampanel|Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day.
10904203|NCT00585052|BG000|Baseline|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
10904204|NCT00585052|FG000|Participant Flow|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
10904205|NCT00585052|OG000|Outcome|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
10904206|NCT00585052|EG000|Reported Event|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
10904207|NCT00585078|BG000|Baseline|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
10904208|NCT00585078|FG000|Participant Flow|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
10904209|NCT00585078|OG000|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
10904210|NCT00585078|EG000|Reported Event|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
10904211|NCT00585104|BG000|Baseline|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
10904212|NCT00585104|FG000|Participant Flow|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
10904213|NCT00585104|OG000|Outcome|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
10904214|NCT00585104|EG000|Reported Event|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
10904215|NCT00585169|BG000|Baseline|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
10904216|NCT00585169|FG000|Participant Flow|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
10904217|NCT00585169|OG000|Outcome|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
10904218|NCT00585169|EG000|Reported Event|Memantine 10mg|
10904219|NCT00585169|EG001|Reported Event|Memantine 20mg|
10904220|NCT00585169|EG002|Reported Event|Memantine 30mg|
10904221|NCT00585182|BG000|Baseline|Enoxaparin 0.5mg/kg Once Daily|
10904222|NCT00585182|FG000|Participant Flow|Enoxaparin 0.5mg/kg Once Daily|
11174204|NCT02020278|OG000|Outcome|Optional Tolvaptan Treatment Component|The duration for the optional tolvaptan treatment (referred to as optional tolvaptan treatment component) was to be case-specific. It could have been short-term or long-term and could have consisted of 1 or more treatment cycles. Eligibility for optional tolvaptan treatment was to be determined at the pretreatment baseline visit of each dosing cycle. Each tolvaptan treatment cycle was to include a titration phase of up to 4 days and interruption of tolvaptan for up to 2 doses after 30 (±1) days of tolvaptan treatment. Due to early study termination, no participant entered the Optional Tolvaptan Treatment Component of this study.
10904223|NCT00585182|OG000|Outcome|Enoxaparin 0.5mg/kg Once Daily|
10904224|NCT00585182|EG000|Reported Event|Enoxaparin 0.5mg/kg Once Daily|
10904225|NCT00585247|BG000|Baseline|Imiquimod|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment imiquimod 5% cream for 8 weeks."
10904226|NCT00585247|BG001|Baseline|Placebo|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks."
10904227|NCT00585247|BG002|Baseline|Total|Total of all reporting groups
10904228|NCT00585247|FG000|Participant Flow|Imiquimod|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Healthy individuals with PWS (n = 14) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)"
10904229|NCT00585247|FG001|Participant Flow|Placebo|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Healthy individuals with PWS (n = 13) were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks for 57 PWS sites (multiple sites per patient)"
10904230|NCT00585247|OG000|Outcome|Imiquimod|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks"
10904231|NCT00585247|OG001|Outcome|Placebo|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks"
10904232|NCT00585247|EG000|Reported Event|Imiquimod|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)"
10904233|NCT00585247|EG001|Reported Event|Placebo|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks for 57 PWS sites (multiple sites per patient)"
10904234|NCT00585286|BG000|Baseline|Fractional CO2 Laser System|Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
10904235|NCT00585286|FG000|Participant Flow|Fractional Carbon Dioxide Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.
10904236|NCT00585286|OG000|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
10904237|NCT00585286|EG000|Reported Event|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
10904238|NCT00585312|BG000|Baseline|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
10904239|NCT00585312|BG001|Baseline|Placebo|Matching placebo
10904240|NCT00585312|BG002|Baseline|Total|Total of all reporting groups
10904241|NCT00585312|FG000|Participant Flow|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
10904242|NCT00585312|FG001|Participant Flow|Placebo|Matching placebo
10904243|NCT00585312|OG000|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
10904244|NCT00585312|OG001|Outcome|Placebo|Matching placebo
10904245|NCT00585312|EG000|Reported Event|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
10904246|NCT00585312|EG001|Reported Event|Placebo|Matching placebo
10904247|NCT00585325|BG000|Baseline|Instilled 1% Lidocaine|5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
10904248|NCT00585325|BG001|Baseline|Instilled Placebo (0.9% Normal Saline)|receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
10904249|NCT00585325|BG002|Baseline|Total|Total of all reporting groups
10904250|NCT00585325|FG000|Participant Flow|Instilled 1% Lidocaine|5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
10904251|NCT00585325|FG001|Participant Flow|Instilled Placebo (0.9% Normal Saline)|receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
10914999|NCT00633880|BG000|Baseline|Not Randomized|Entered open-label droxidopa dose titration, but did not randomize
10904252|NCT00585325|OG000|Outcome|Instilled 1% Lidocaine|"5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change~Instilled 1% Lidocaine: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change"
10904253|NCT00585325|OG001|Outcome|Instilled Placebo (0.9% Normal Saline)|"receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change~Placebo (0.9% Normal Saline): .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change"
10904254|NCT00585325|EG000|Reported Event|Instilled 1% Lidocaine|5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
10904255|NCT00585325|EG001|Reported Event|Instilled Placebo (0.9% Normal Saline)|receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
10904256|NCT00585351|BG000|Baseline|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
10904257|NCT00585351|BG001|Baseline|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
10904258|NCT00585351|BG002|Baseline|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
10904259|NCT00585351|BG003|Baseline|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
10904260|NCT00585351|BG004|Baseline|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
10904261|NCT00585351|BG005|Baseline|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
10904262|NCT00585351|BG006|Baseline|Total|Total of all reporting groups
10904263|NCT00585351|FG000|Participant Flow|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
10904264|NCT00585351|FG001|Participant Flow|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
10904265|NCT00585351|FG002|Participant Flow|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
10904266|NCT00585351|FG003|Participant Flow|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
10904267|NCT00585351|FG004|Participant Flow|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
10904268|NCT00585351|FG005|Participant Flow|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
10904269|NCT00585351|FG006|Participant Flow|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
11233408|NCT02427607|OG000|Outcome|Perampanel|Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day.
10904270|NCT00585351|FG007|Participant Flow|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
10904271|NCT00585351|OG000|Outcome|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
10904272|NCT00585351|OG001|Outcome|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
10904273|NCT00585351|OG000|Outcome|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
10904274|NCT00585351|OG001|Outcome|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
10904275|NCT00585351|OG002|Outcome|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
10904276|NCT00585351|OG003|Outcome|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
11091019|NCT01532908|BG001|Baseline|Part 2: MBL-HCV1 and Sofosbuvir|"MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56~Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56"
11091020|NCT01532908|BG002|Baseline|Total|Total of all reporting groups
11091021|NCT01532908|FG000|Participant Flow|Part 1: MBL-HCV1 and Telaprevir|"MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56~Telaprevir (Part 1): Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56"
11091022|NCT01532908|FG001|Participant Flow|Part 2: MBL-HCV1 and Sofosbuvir|"MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56~Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56"
11091023|NCT01532908|OG000|Outcome|Part 1: MBL-HCV1 and Telaprevir|"MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56~Telaprevir (Part 1): Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56"
11091024|NCT01532908|OG001|Outcome|Part 2: MBL-HCV1 and Sofosbuvir|"MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56~Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56"
11091025|NCT01532908|EG000|Reported Event|Part 1: MBL-HCV1 and Telaprevir|"MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56~Telaprevir (Part 1): Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56"
11091026|NCT01532908|EG001|Reported Event|Part 2: MBL-HCV1 and Sofosbuvir|"MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56~Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56"
10904277|NCT00585351|EG000|Reported Event|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
10904278|NCT00585351|EG001|Reported Event|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
10904279|NCT00585351|EG002|Reported Event|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
10904280|NCT00585351|EG003|Reported Event|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
11091027|NCT01532921|BG000|Baseline|Indicated for a TV Repair Procedure|All patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
11091028|NCT01532921|FG000|Participant Flow|Indicated for a TV Repair Procedure|All patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
11091029|NCT01532921|OG000|Outcome|Baseline|All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
11091030|NCT01532921|OG001|Outcome|Discharge (up to 5 Days Post-implant)|All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
11091031|NCT01532921|OG002|Outcome|6 Months Follow-Up|All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
11091032|NCT01532921|OG000|Outcome|Discharge (up to 5 Days Post-implant)|All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
10904281|NCT00585351|EG004|Reported Event|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
10904282|NCT00585351|EG005|Reported Event|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
10904283|NCT00585377|BG000|Baseline|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
10904284|NCT00585377|FG000|Participant Flow|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
10904285|NCT00585377|OG000|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
10904286|NCT00585377|EG000|Reported Event|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
10904287|NCT00585468|BG000|Baseline|Entire Study Population|Includes groups randomized to the Fed State first and to the Fasted State first
10904288|NCT00585468|FG000|Participant Flow|Fed State First, Then Fasting State|720 milligrams (mg) mycophenolate sodium orally twice daily with a meal for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily separated by food by 2 hours in the second intervention period.
10904289|NCT00585468|FG001|Participant Flow|Fasting State First, Then Fed State|720 mg mycophenolate sodium orally twice daily separated from food by 2 hours for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily with a meal in the second intervention period.
10904290|NCT00585468|OG000|Outcome|Myfortic - Fed State|Mycophenolate sodium taken with a meal
10904291|NCT00585468|OG001|Outcome|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
11091033|NCT01532921|OG001|Outcome|6 Months Follow-Up|All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
11091034|NCT01532921|EG000|Reported Event|Adverse Events Within 6 Months of Implant Procedure|
11091035|NCT01532934|BG000|Baseline|Brief Motivational Intervention Plus Standard Care (BMI+SC)|Brief Motivational Intervention plus Standard Care; Individuals received up to 4 intervention sessions plus assessment and the usual range of services provided by Monroe County Pretrial
11091036|NCT01532934|BG001|Baseline|Standard Care (SC)|Standard Care: Individuals received assessment only, plus the usual range of services provided by Monroe County Pretrial
10904292|NCT00585468|OG000|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
11091037|NCT01532934|BG002|Baseline|Total|Total of all reporting groups
11091038|NCT01532934|FG000|Participant Flow|Brief Therapy|"motivational enhancement therapy for substance use~motivational enhancement therapy: Four 45-minute MET sessions"
11091039|NCT01532934|FG001|Participant Flow|Standard Care|"standard care~standard care: standard care"
11091040|NCT01532934|OG000|Outcome|BMI+SC|"brief MI + standard care~standard care"
11091041|NCT01532934|OG001|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
10904293|NCT00585468|OG001|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
10904294|NCT00585468|EG000|Reported Event|Myfortic - Fed State|Mycophenolate sodium taken with a meal
10904295|NCT00585468|EG001|Reported Event|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
10904296|NCT00585494|BG000|Baseline|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
10904297|NCT00585494|FG000|Participant Flow|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
10904298|NCT00585494|OG000|Outcome|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
10904299|NCT00585494|EG000|Reported Event|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
10904300|NCT00585533|BG000|Baseline|All Participants|All participants enrolled in trial.
10904301|NCT00585533|FG000|Participant Flow|All Participants|All participants enrolled in trial.
10904302|NCT00585533|OG000|Outcome|All Participants|All participants enrolled in trial.
10904303|NCT00585533|EG000|Reported Event|All Participants|All participants enrolled in trial.
10904304|NCT00585546|BG000|Baseline|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
10904305|NCT00585546|FG000|Participant Flow|LVAD and (Intended) Clenbuterol|"Participants, all of whom received LVAD implantation, were to begin clenbuterol treatment 12 weeks after their implantation.~Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months."
10904306|NCT00585546|OG000|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
10904307|NCT00585546|EG000|Reported Event|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
10904308|NCT00585637|BG000|Baseline|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
10904309|NCT00585637|BG001|Baseline|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904310|NCT00585637|BG002|Baseline|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904311|NCT00585637|BG003|Baseline|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904312|NCT00585637|BG004|Baseline|Total|Total of all reporting groups
10904313|NCT00585637|FG000|Participant Flow|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
11091042|NCT01532934|OG000|Outcome|Brief Therapy|"motivational enhancement therapy for substance use~motivational enhancement therapy: Four 45-minute MET sessions"
10904314|NCT00585637|FG001|Participant Flow|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904315|NCT00585637|FG002|Participant Flow|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904316|NCT00585637|FG003|Participant Flow|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904317|NCT00585637|OG000|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
10904318|NCT00585637|OG001|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904319|NCT00585637|OG002|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904320|NCT00585637|OG003|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904321|NCT00585637|EG000|Reported Event|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
10904322|NCT00585637|EG001|Reported Event|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904323|NCT00585637|EG002|Reported Event|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904324|NCT00585637|EG003|Reported Event|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
10904325|NCT00585650|BG000|Baseline|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks.
10904326|NCT00585650|BG001|Baseline|Subjects Receiving Placebo for 12 Weeks|Subjects randomized to placebo injection twice weekly for 12 weeks.
10904327|NCT00585650|BG002|Baseline|Total|Total of all reporting groups
10904328|NCT00585650|FG000|Participant Flow|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects were randomized to receive etanercept 50mg twice weekly injection for 12 weeks. Subjects were then treated for another 12 weeks with etanercept 50 mg twice weekly. An additional follow-up visit performed on week 28.
10904329|NCT00585650|FG001|Participant Flow|Subjects Receiving Placebo for 12 Weeks|Subjects randomized to receive placebo injection twice weekly for 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50 mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
10904330|NCT00585650|OG000|Outcome|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks.
10904331|NCT00585650|OG001|Outcome|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for 12 weeks.
10904332|NCT00585650|EG000|Reported Event|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
10904333|NCT00585650|EG001|Reported Event|Subjects Receiving Placebo for 12 Weeks|Subjects randomized placebo injection for 12 weeks. An additional follow-up visit was performed on week 28.
10904334|NCT00585689|BG000|Baseline|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
10904335|NCT00585689|FG000|Participant Flow|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
10904336|NCT00585689|OG000|Outcome|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
10904337|NCT00585689|EG000|Reported Event|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
10915000|NCT00633880|BG001|Baseline|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10915001|NCT00633880|BG002|Baseline|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10915002|NCT00633880|BG003|Baseline|Total|Total of all reporting groups
11091043|NCT01532934|OG001|Outcome|Standard Care|"standard care~standard care: standard care"
10904338|NCT00585715|BG000|Baseline|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
10904339|NCT00585715|BG001|Baseline|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
10904340|NCT00585715|BG002|Baseline|Total|Total of all reporting groups
10904341|NCT00585715|FG000|Participant Flow|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
10904342|NCT00585715|FG001|Participant Flow|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
10904343|NCT00585715|OG000|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
10904344|NCT00585715|OG001|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
10904345|NCT00585715|EG000|Reported Event|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
10904346|NCT00585715|EG001|Reported Event|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
10904347|NCT00585780|BG000|Baseline|High Alcohol Withdrawal on Prazosin|High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
10904348|NCT00585780|BG001|Baseline|High Alcohol Withdrawal on PLA|High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to matching Placebo tablets (tid) for 12 weeks.
10904349|NCT00585780|BG002|Baseline|Low Alcohol Withdrawal on Prazosin|Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
10904350|NCT00585780|BG003|Baseline|Low Alcohol Withdrawal on PLA|Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 2 randomized to matching Placebo tablets (tid) for 12 weeks.
10904351|NCT00585780|BG004|Baseline|Total|Total of all reporting groups
10904352|NCT00585780|FG000|Participant Flow|High Alcohol Withdrawal on Prazosin|High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
10904353|NCT00585780|FG001|Participant Flow|High Alcohol Withdrawal on PLA|High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to matching Placebo tablets (tid) for 12 weeks.
10904354|NCT00585780|FG002|Participant Flow|Low Alcohol Withdrawal on Prazosin|Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
10904355|NCT00585780|FG003|Participant Flow|Low Alcohol Withdrawal on PLA|Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 2 randomized to matching Placebo tablets (tid) for 12 weeks.
10904356|NCT00585780|OG000|Outcome|High Alcohol Withdrawal (AW) on Prazosin|High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
10904357|NCT00585780|OG001|Outcome|High Alcohol Withdrawal (AW) on PLA|High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to matching Placebo tablets (tid) for 12 weeks.
10904358|NCT00585780|OG002|Outcome|Low Alcohol Withdrawal (AW) on Prazosin|Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
10904359|NCT00585780|OG003|Outcome|Low Alcohol Withdrawal (AW) on PLA|Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 2 randomized to matching Placebo tablets (tid) for 12 weeks.
10904360|NCT00585780|OG000|Outcome|High Alcohol Withdrawal on Prazosin|High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
10904361|NCT00585780|OG001|Outcome|High Alcohol Withdrawal on PLA|High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to matching Placebo tablets (tid) for 12 weeks.
10904362|NCT00585780|OG002|Outcome|Low Alcohol Withdrawal on Prazosin|Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
10904363|NCT00585780|OG003|Outcome|Low Alcohol Withdrawal on PLA|Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 2 randomized to matching Placebo tablets (tid) for 12 weeks.
10904364|NCT00585780|EG000|Reported Event|High Alcohol Withdrawal on Prazosin|"High AW scoring at or above 3 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Prazosin 16 mg/day (tid) administered for 12 weeks.~Prazosin Tablet: Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research."
10904365|NCT00585780|EG001|Reported Event|High Alcohol Withdrawal on PLA|"High AW scoring at or above 3 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Placebo tablets administered tid for 12 weeks in a double blind manner.~Placebo Tablet: Placebo tablets identical in appearance and dosing schedule as the active study medication was utilized"
10915003|NCT00633880|FG000|Participant Flow|Open Label Titration|All patients titrated to their optimal dose of droxidopa during an initial open label phase for 7-14 days
11091044|NCT01532934|EG000|Reported Event|Brief Motivational Intervention Plus Standard Care|There were no adverse events for members of this group.
10904366|NCT00585780|EG002|Reported Event|Low Alcohol Withdrawal on Prazosin|"Low AW scoring at or below 2 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Prazosin 16 mg/day (tid) administered for 12 weeks in a double blind manner.~Prazosin Tablet: Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research."
10904367|NCT00585780|EG003|Reported Event|Low Alcohol Withdrawal on PLA|"Low AW scoring at or below 2 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment and randomized to Placebo tablets administered tid for 12 weeks in a double blind manner.~Placebo Tablet: Placebo tablets identical in appearance and dosing schedule as the active study medication was utilized"
10904368|NCT00585910|BG000|Baseline|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
10904369|NCT00585910|FG000|Participant Flow|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
10904370|NCT00585910|OG000|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
10904371|NCT00585910|EG000|Reported Event|ATMX Only|Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase.
10904372|NCT00585910|EG001|Reported Event|ATMX and OROS MPH|Partial responders to ATMX alone entered into the ATMX and OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
10904373|NCT00585923|BG000|Baseline|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
10904374|NCT00585923|BG001|Baseline|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
11233409|NCT02427607|EG000|Reported Event|Perampanel|Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day.
10904375|NCT00585923|BG002|Baseline|Total|Total of all reporting groups
10904376|NCT00585923|FG000|Participant Flow|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
10904377|NCT00585923|FG001|Participant Flow|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
10904378|NCT00585923|OG000|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
10904379|NCT00585923|OG001|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
10904380|NCT00585923|EG000|Reported Event|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
10904381|NCT00585923|EG001|Reported Event|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
10904382|NCT00585975|BG000|Baseline|Bromfenac Ophthalmic Solution 0.18%|
10904383|NCT00585975|BG001|Baseline|Xibrom 0.09%|
10904384|NCT00585975|BG002|Baseline|Total|Total of all reporting groups
10904385|NCT00585975|FG000|Participant Flow|Bromfenac Ophthalmic Solution 0.18%|
10904386|NCT00585975|FG001|Participant Flow|Xibrom 0.09%|
10904387|NCT00585975|OG000|Outcome|Bromfenac Ophthalmic Solution 0.18%|
10904388|NCT00585975|OG001|Outcome|Xibrom 0.09%|
10904389|NCT00585975|EG000|Reported Event|Bromfenac Ophthalmic Solution 0.18%|
10904390|NCT00585975|EG001|Reported Event|Xibrom 0.09%|
10904391|NCT00586001|BG000|Baseline|Unified Treatment|Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
10904392|NCT00586001|BG001|Baseline|Wait-list Control|Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
10904393|NCT00586001|BG002|Baseline|Total|Total of all reporting groups
10904394|NCT00586001|FG000|Participant Flow|Unified Treatment|Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
10904395|NCT00586001|FG001|Participant Flow|Wait-List Control|Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
10904396|NCT00586001|OG000|Outcome|Unified Treatment|Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
10904397|NCT00586001|OG001|Outcome|Wait-list Control|Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
10904398|NCT00586001|OG001|Outcome|Wait-List Control|Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
10904399|NCT00586001|EG000|Reported Event|Unified Treatment|Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
10904400|NCT00586001|EG001|Reported Event|Wait-list Control|Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
10904401|NCT00586066|BG000|Baseline|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
10904402|NCT00586066|BG001|Baseline|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
10904403|NCT00586066|BG002|Baseline|Total|Total of all reporting groups
10904404|NCT00586066|FG000|Participant Flow|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
10904405|NCT00586066|FG001|Participant Flow|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
10904406|NCT00586066|OG000|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
10904407|NCT00586066|OG001|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
10904408|NCT00586066|EG000|Reported Event|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
10904409|NCT00586066|EG001|Reported Event|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
10904410|NCT00586105|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
10904411|NCT00586105|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
10904412|NCT00586105|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
10904413|NCT00586105|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
10904414|NCT00586157|BG000|Baseline|Entire Study Population|
10904415|NCT00586157|FG000|Participant Flow|MTS Then Placebo|MTS in first intervention then Placebo in second intervention
10904416|NCT00586157|FG001|Participant Flow|Placebo Then MTS|Placebo in first intervention then MTS in second intervention
10904417|NCT00586157|OG000|Outcome|MTS (Drug A)|
10904418|NCT00586157|OG001|Outcome|Placebo|
10904419|NCT00586157|EG000|Reported Event|MTS (Drug A)|
10904420|NCT00586157|EG001|Reported Event|Placebo|
10904421|NCT00586170|BG000|Baseline|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
10904422|NCT00586170|BG001|Baseline|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
10904423|NCT00586170|BG002|Baseline|Total|Total of all reporting groups
10904424|NCT00586170|FG000|Participant Flow|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
10904425|NCT00586170|FG001|Participant Flow|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
10904426|NCT00586170|OG000|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
10904427|NCT00586170|OG001|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
10904428|NCT00586170|EG000|Reported Event|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
10904429|NCT00586170|EG001|Reported Event|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
10904430|NCT00586196|BG000|Baseline|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
10904431|NCT00586196|BG001|Baseline|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
10904432|NCT00586196|BG002|Baseline|Total|Total of all reporting groups
10904433|NCT00586196|FG000|Participant Flow|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
10904434|NCT00586196|FG001|Participant Flow|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
10904435|NCT00586196|OG000|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
10904436|NCT00586196|OG001|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
10904437|NCT00586196|EG000|Reported Event|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
10904438|NCT00586196|EG001|Reported Event|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
10904439|NCT00586261|BG000|Baseline|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months~pioglitazone : pioglitazone 30 mg daily for 6 months"
10904440|NCT00586261|BG001|Baseline|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months~placebo : placebo 30 mg daily for 6 months"
10904441|NCT00586261|BG002|Baseline|Total|Total of all reporting groups
10904442|NCT00586261|FG000|Participant Flow|Pioglitazone|Pioglitazone 30 mg daily for 6 months
10904443|NCT00586261|FG001|Participant Flow|Placebo|Placebo 30 mg daily for 6 months
10904444|NCT00586261|OG000|Outcome|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months~pioglitazone : pioglitazone 30 mg daily for 6 months"
10904445|NCT00586261|OG001|Outcome|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months~placebo : placebo 30 mg daily for 6 months"
10904446|NCT00586261|EG000|Reported Event|Pioglitazone|Pioglitazone 30 mg daily for six months
10904447|NCT00586261|EG001|Reported Event|Placebo|Placebo 30 mg daily for six months
10904448|NCT00586313|BG000|Baseline|Participants Undergoing the Tru-Cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
10904449|NCT00586313|FG000|Participant Flow|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
10904450|NCT00586313|OG000|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
10904451|NCT00586313|EG000|Reported Event|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
10904452|NCT00586326|BG000|Baseline|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
10904453|NCT00586326|FG000|Participant Flow|Enrolled|Women with DCIS who were willing to enroll and consented
10904454|NCT00586326|OG000|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
10904455|NCT00586326|OG000|Outcome|Excellent|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Excellent' at 5 years
10904456|NCT00586326|OG001|Outcome|Good|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years
10904457|NCT00586326|OG002|Outcome|Fair|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years
10904458|NCT00586326|OG003|Outcome|Poor|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
10904459|NCT00586326|EG000|Reported Event|Intent to Treat|Enrolled subjects with MammoSite device placed
10904460|NCT00586339|BG000|Baseline|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
10904461|NCT00586339|BG001|Baseline|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10904462|NCT00586339|BG002|Baseline|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10904463|NCT00586339|BG003|Baseline|Total|Total of all reporting groups
10904464|NCT00586339|FG000|Participant Flow|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
10904465|NCT00586339|FG001|Participant Flow|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10904466|NCT00586339|FG002|Participant Flow|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10904467|NCT00586339|OG000|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
10904468|NCT00586339|OG001|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10904469|NCT00586339|OG002|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10904470|NCT00586339|EG000|Reported Event|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
10904471|NCT00586339|EG001|Reported Event|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10904472|NCT00586339|EG002|Reported Event|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
10904473|NCT00586469|BG000|Baseline|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
10904474|NCT00586469|BG001|Baseline|New Bulk|This group received a full dose of Fluviral made from new material
10904475|NCT00586469|BG002|Baseline|Total|Total of all reporting groups
10904476|NCT00586469|FG000|Participant Flow|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
10904477|NCT00586469|FG001|Participant Flow|New Bulk|This group received a full dose of Fluviral made from new material
10904478|NCT00586469|OG000|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
10904479|NCT00586469|OG001|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
10904480|NCT00586469|EG000|Reported Event|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
10904481|NCT00586469|EG001|Reported Event|New Bulk|This group received a full dose of Fluviral made from new material
10915004|NCT00633880|FG001|Participant Flow|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
11172165|NCT02007369|EG000|Reported Event|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
11172166|NCT02007369|EG001|Reported Event|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
11172167|NCT02007369|EG002|Reported Event|Control|No intervention
11172168|NCT02007434|BG000|Baseline|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
11172169|NCT02007434|BG001|Baseline|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
11172170|NCT02007434|BG002|Baseline|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
11172171|NCT02007434|BG003|Baseline|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172172|NCT02007434|BG004|Baseline|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
11172173|NCT02007434|BG005|Baseline|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
10904482|NCT00586482|BG000|Baseline|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
10904483|NCT00586482|BG001|Baseline|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
10904484|NCT00586482|BG002|Baseline|Total|Total of all reporting groups
10904485|NCT00586482|FG000|Participant Flow|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
10904486|NCT00586482|FG001|Participant Flow|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
10904487|NCT00586482|OG000|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
10904488|NCT00586482|OG001|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
10904489|NCT00586482|EG000|Reported Event|Nicotine Lozenge|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
10904490|NCT00586482|EG001|Reported Event|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
10904491|NCT00586495|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
10904492|NCT00586495|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
10904493|NCT00586495|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
10904494|NCT00586495|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
10904495|NCT00586508|BG000|Baseline|Enzastaurin + Bevacizumab (NEIAED)|"Enzastaurin: 1125 mg loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on NEIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles).~Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).~Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met."
10904496|NCT00586508|BG001|Baseline|Enzastaurin + Bevacizumab (EIAED)|"Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on EIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles).~Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).~Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met."
10904497|NCT00586508|BG002|Baseline|Total|Total of all reporting groups
11172174|NCT02007434|BG006|Baseline|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172175|NCT02007434|BG007|Baseline|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172176|NCT02007434|BG008|Baseline|Total|Total of all reporting groups
10904498|NCT00586508|FG000|Participant Flow|Enzastaurin + Bevacizumab (NEIAED)|"Enzastaurin: 1125 milligrams (mg) loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on non-enzyme inducing antiepileptic drugs (NEIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles).~Bevacizumab: 10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks. Participants were evaluated after each cycle (4-week cycles).~Cycles repeated until there was evidence of progressive disease (PD), significant toxicity, withdrawal of consent, or other discontinuation criteria were met."
10904499|NCT00586508|FG001|Participant Flow|Enzastaurin + Bevacizumab (EIAED)|"Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on enzyme inducing antiepileptic drugs (EIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles).~Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).~Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met."
10904500|NCT00586508|OG000|Outcome|Enzastaurin + Bevacizumab (NEIAED)|"Enzastaurin: 1125 mg loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on NEIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles).~Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).~Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met."
10904501|NCT00586508|OG001|Outcome|Enzastaurin + Bevacizumab (EIAED)|"Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on EIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles).~Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).~Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met."
10904502|NCT00586508|EG000|Reported Event|Enzastaurin + Bevacizumab (NEIAED)|"Enzastaurin: 1125 milligrams (mg) loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on non-enzyme inducing antiepileptic drugs (NEIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles).~Bevacizumab: 10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks. Participants were evaluated after each cycle (4-week cycles).~Cycles repeated until there was evidence of progressive disease (PD), significant toxicity, withdrawal of consent, or other discontinuation criteria were met."
10904503|NCT00586508|EG001|Reported Event|Enzastaurin + Bevacizumab (EIAED)|"Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on enzyme inducing antiepileptic drugs (EIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles).~Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).~Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met."
10904504|NCT00586521|BG000|Baseline|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
10904505|NCT00586521|FG000|Participant Flow|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
10904506|NCT00586521|OG000|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
10904507|NCT00586521|EG000|Reported Event|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
10904508|NCT00586573|BG000|Baseline|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
10904509|NCT00586573|FG000|Participant Flow|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
10904510|NCT00586573|OG000|Outcome|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
10904511|NCT00586573|EG000|Reported Event|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
10904512|NCT00586612|BG000|Baseline|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
10904513|NCT00586612|BG001|Baseline|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
10904514|NCT00586612|BG002|Baseline|Total|Total of all reporting groups
10904515|NCT00586612|FG000|Participant Flow|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
10904516|NCT00586612|FG001|Participant Flow|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
10904517|NCT00586612|OG000|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
10904518|NCT00586612|OG001|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
10904519|NCT00586612|EG000|Reported Event|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
10904520|NCT00586612|EG001|Reported Event|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
10904521|NCT00586625|BG000|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
10904522|NCT00586625|BG001|Baseline|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
10904523|NCT00586625|BG002|Baseline|Total|Total of all reporting groups
10904524|NCT00586625|FG000|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
10904525|NCT00586625|FG001|Participant Flow|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
10904526|NCT00586625|OG000|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
10904527|NCT00586625|OG001|Outcome|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
10904528|NCT00586625|EG000|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
10904529|NCT00586625|EG001|Reported Event|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
10904530|NCT00586664|BG000|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904531|NCT00586664|BG001|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904532|NCT00586664|BG002|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904533|NCT00586664|BG003|Baseline|Total|Total of all reporting groups
10904534|NCT00586664|FG000|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904535|NCT00586664|FG001|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904536|NCT00586664|FG002|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904537|NCT00586664|OG000|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904538|NCT00586664|OG001|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904539|NCT00586664|OG002|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904540|NCT00586664|EG000|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904541|NCT00586664|EG001|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904542|NCT00586664|EG002|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
10904543|NCT00586690|BG000|Baseline|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
10904544|NCT00586690|BG001|Baseline|Donor Apheresis|Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
10904545|NCT00586690|BG002|Baseline|Total|Total of all reporting groups
10904546|NCT00586690|FG000|Participant Flow|NK Cell Infusion|NK Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
10904547|NCT00586690|FG001|Participant Flow|Donor Apheresis|Leukapheresis was repeated daily up to 3 days until the target dose of cells was reached (preferably without donor receiving growth factors). When possible, cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These collections, which are extra cells collected from the donor following initial collections for transplant were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
10904548|NCT00586690|OG000|Outcome|NK Cell Infusion|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:~The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion."
10904549|NCT00586690|OG000|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
10904550|NCT00586690|EG000|Reported Event|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
10904551|NCT00586703|BG000|Baseline|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
10904552|NCT00586703|FG000|Participant Flow|Experimental: NK-CD56|"NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors~NK Cell Infusion following SCT from mismatched donors : The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
10904553|NCT00586703|OG000|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
10904554|NCT00586703|EG000|Reported Event|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
10904555|NCT00586729|BG000|Baseline|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
10904556|NCT00586729|BG001|Baseline|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
10904557|NCT00586729|BG002|Baseline|Total|Total of all reporting groups
10904558|NCT00586729|FG000|Participant Flow|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
10904559|NCT00586729|FG001|Participant Flow|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
10904560|NCT00586729|OG000|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
10904561|NCT00586729|OG001|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
10904562|NCT00586729|EG000|Reported Event|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
10904563|NCT00586729|EG001|Reported Event|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
10904564|NCT00586820|BG000|Baseline|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
10904565|NCT00586820|BG001|Baseline|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
10904566|NCT00586820|BG002|Baseline|Total|Total of all reporting groups
10904567|NCT00586820|FG000|Participant Flow|BQ-123|The selective endothelin type A receptor antagonist (BQ-123) will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
10904568|NCT00586820|FG001|Participant Flow|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
10904569|NCT00586820|OG000|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
10904570|NCT00586820|OG001|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
10904571|NCT00586820|EG000|Reported Event|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
10904572|NCT00586820|EG001|Reported Event|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion for 20 minutes prior to PCI.
10904573|NCT00586846|BG000|Baseline|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
10904574|NCT00586846|FG000|Participant Flow|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
10904575|NCT00586846|OG000|Outcome|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
10904576|NCT00586846|EG000|Reported Event|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
10904577|NCT00586898|BG000|Baseline|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
10904578|NCT00586898|FG000|Participant Flow|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
10904579|NCT00586898|OG000|Outcome|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
10904580|NCT00586898|EG000|Reported Event|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
10904581|NCT00587041|BG000|Baseline|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
10904582|NCT00587041|BG001|Baseline|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
10904583|NCT00587041|BG002|Baseline|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
10904584|NCT00587041|BG003|Baseline|Total|Total of all reporting groups
10904585|NCT00587041|FG000|Participant Flow|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
10904586|NCT00587041|FG001|Participant Flow|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
10904587|NCT00587041|FG002|Participant Flow|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
10904588|NCT00587041|OG000|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
10904589|NCT00587041|OG001|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
10904590|NCT00587041|OG002|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
10904591|NCT00587041|EG000|Reported Event|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
10904592|NCT00587041|EG001|Reported Event|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
10904593|NCT00587041|EG002|Reported Event|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
10904594|NCT00587054|BG000|Baseline|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
10904595|NCT00587054|FG000|Participant Flow|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
11091045|NCT01532934|EG001|Reported Event|Standard Care|There were no adverse events for members of this group.
11091046|NCT01532973|BG000|Baseline|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis who received 10 -mg elbasvir for 5 consecutive days during Part I of the study.
11091047|NCT01532973|BG001|Baseline|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir for 5 consecutive days during Part I of the study.
11091048|NCT01532973|BG002|Baseline|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir for 5 consecutive days during Part I of the study.
11091049|NCT01532973|BG003|Baseline|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir for 5 consecutive days during Part II of the study.
11091050|NCT01532973|BG004|Baseline|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir for 5 consecutive days during Part II of the study.
11091051|NCT01532973|BG005|Baseline|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir for 5 consecutive days during Part II of the study.
11091052|NCT01532973|BG006|Baseline|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir for 5 consecutive days during Part III of the study.
11091053|NCT01532973|BG007|Baseline|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir for 5 consecutive days during Part III of the study.
11091054|NCT01532973|BG008|Baseline|Placebo|Participants with GT1, GT3 or GT1a HCV who received placebo in Parts I, II, or II of the study.
11091055|NCT01532973|BG009|Baseline|Total|Total of all reporting groups
11172177|NCT02007434|FG000|Participant Flow|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale [CR-SMFRS] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.
11172178|NCT02007434|FG001|Participant Flow|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
10904596|NCT00587054|OG000|Outcome|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
10904597|NCT00587054|EG000|Reported Event|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
10904598|NCT00587067|BG000|Baseline|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate~* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
10904599|NCT00587067|FG000|Participant Flow|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate~* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
10904600|NCT00587067|OG000|Outcome|Floxuridine + Dexamethasone|Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
10904601|NCT00587067|EG000|Reported Event|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate~* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
10904602|NCT00587132|BG000|Baseline|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904603|NCT00587132|BG001|Baseline|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904604|NCT00587132|BG002|Baseline|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904605|NCT00587132|BG003|Baseline|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
10904606|NCT00587132|BG004|Baseline|Total|Total of all reporting groups
10904607|NCT00587132|FG000|Participant Flow|New Onset Diabetes|"Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
11172179|NCT02007434|FG002|Participant Flow|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
11172180|NCT02007434|FG003|Participant Flow|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
10904608|NCT00587132|FG001|Participant Flow|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904609|NCT00587132|FG002|Participant Flow|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
11172181|NCT02007434|FG004|Participant Flow|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
11172182|NCT02007434|FG005|Participant Flow|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
10904610|NCT00587132|FG003|Participant Flow|Clinical Symptoms of Pancreatic Cancer, Normal CT|Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
10904611|NCT00587132|OG000|Outcome|New Onset Diabetes|"Adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904612|NCT00587132|OG001|Outcome|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904613|NCT00587132|OG002|Outcome|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904614|NCT00587132|OG003|Outcome|Clinical Symptoms of Pancreatic Cancer, Normal CT|"Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904615|NCT00587132|EG000|Reported Event|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904616|NCT00587132|EG001|Reported Event|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904617|NCT00587132|EG002|Reported Event|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
10904618|NCT00587132|EG003|Reported Event|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
10904619|NCT00587158|BG000|Baseline|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
10904620|NCT00587158|BG001|Baseline|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
10904621|NCT00587158|BG002|Baseline|Total|Total of all reporting groups
10904622|NCT00587158|FG000|Participant Flow|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
10904623|NCT00587158|FG001|Participant Flow|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive therapy consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®). In addition, subjects in this group will receive the study medication paricalcitol (Zemplar®).
10904624|NCT00587158|OG000|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
10904625|NCT00587158|OG001|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
10904626|NCT00587158|EG000|Reported Event|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
10904627|NCT00587158|EG001|Reported Event|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
10904628|NCT00587171|BG000|Baseline|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
10904629|NCT00587171|BG001|Baseline|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
10904630|NCT00587171|BG002|Baseline|Total|Total of all reporting groups
10904631|NCT00587171|FG000|Participant Flow|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
10904632|NCT00587171|FG001|Participant Flow|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
10904633|NCT00587171|OG000|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
10904634|NCT00587171|OG001|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
10904635|NCT00587171|EG000|Reported Event|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
10904636|NCT00587171|EG001|Reported Event|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
10904637|NCT00587288|BG000|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904638|NCT00587288|BG001|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904639|NCT00587288|BG002|Baseline|Total|Total of all reporting groups
10904640|NCT00587288|FG000|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904641|NCT00587288|FG001|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904642|NCT00587288|OG000|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904643|NCT00587288|OG001|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904644|NCT00587288|OG000|Outcome|Reslizumab 3 mg/kg|Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904645|NCT00587288|OG001|Outcome|Placebo|Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904646|NCT00587288|EG000|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904647|NCT00587288|EG001|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
10904648|NCT00587431|BG000|Baseline|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
10904649|NCT00587431|BG001|Baseline|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
10904650|NCT00587431|BG002|Baseline|Total|Total of all reporting groups
11172183|NCT02007434|FG006|Participant Flow|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
10904651|NCT00587431|FG000|Participant Flow|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
10904652|NCT00587431|FG001|Participant Flow|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
10904653|NCT00587431|OG000|Outcome|Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
10904654|NCT00587431|OG001|Outcome|Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
10904655|NCT00587431|OG002|Outcome|Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
10904656|NCT00587431|OG003|Outcome|Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)|"(Metastatic) GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
10904657|NCT00587431|OG000|Outcome|All Participants|All participants
10904658|NCT00587431|EG000|Reported Event|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
10904659|NCT00587431|EG001|Reported Event|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
10904660|NCT00587457|BG000|Baseline|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904661|NCT00587457|BG001|Baseline|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904662|NCT00587457|BG002|Baseline|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904663|NCT00587457|BG003|Baseline|Total|Total of all reporting groups
11172184|NCT02007434|FG007|Participant Flow|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
10904664|NCT00587457|FG000|Participant Flow|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904665|NCT00587457|FG001|Participant Flow|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904666|NCT00587457|FG002|Participant Flow|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904667|NCT00587457|OG000|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904668|NCT00587457|OG001|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904669|NCT00587457|OG002|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904670|NCT00587457|EG000|Reported Event|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904671|NCT00587457|EG001|Reported Event|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904672|NCT00587457|EG002|Reported Event|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
10904673|NCT00587483|BG000|Baseline|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904674|NCT00587483|BG001|Baseline|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904675|NCT00587483|BG002|Baseline|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904676|NCT00587483|BG003|Baseline|Total|Total of all reporting groups
10904677|NCT00587483|FG000|Participant Flow|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904678|NCT00587483|FG001|Participant Flow|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904679|NCT00587483|FG002|Participant Flow|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904680|NCT00587483|OG000|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904681|NCT00587483|OG001|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904682|NCT00587483|OG002|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904683|NCT00587483|EG000|Reported Event|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904684|NCT00587483|EG001|Reported Event|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904685|NCT00587483|EG002|Reported Event|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
10904686|NCT00587587|BG000|Baseline|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
10904687|NCT00587587|BG001|Baseline|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
10904688|NCT00587587|BG002|Baseline|Total|Total of all reporting groups
10904689|NCT00587587|FG000|Participant Flow|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
10904690|NCT00587587|FG001|Participant Flow|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
10904691|NCT00587587|OG000|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
10904692|NCT00587587|OG001|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
10904693|NCT00587587|OG000|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
10904694|NCT00587587|OG001|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
10904695|NCT00587587|EG000|Reported Event|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
10904696|NCT00587587|EG001|Reported Event|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
11091056|NCT01532973|FG000|Participant Flow|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with genotype (GT) 1 hepatitis C virus (HCV) receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
11091057|NCT01532973|FG001|Participant Flow|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
11091058|NCT01532973|FG002|Participant Flow|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
11091059|NCT01532973|FG003|Participant Flow|GT1 HCV 200-mg Elbasvir (Panel D)|Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
11091060|NCT01532973|FG004|Participant Flow|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
11091061|NCT01532973|FG005|Participant Flow|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
11091062|NCT01532973|FG006|Participant Flow|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
11091063|NCT01532973|FG007|Participant Flow|GT3 HCV 200-mg Elbasvir (Panel H)|Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
11091064|NCT01532973|FG008|Participant Flow|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
11091065|NCT01532973|FG009|Participant Flow|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
10904697|NCT00587639|BG000|Baseline|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
10904698|NCT00587639|FG000|Participant Flow|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
10904699|NCT00587639|OG000|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
10904700|NCT00587639|EG000|Reported Event|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
10904701|NCT00587678|BG000|Baseline|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
10904702|NCT00587678|BG001|Baseline|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
10904703|NCT00587678|BG002|Baseline|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
10904704|NCT00587678|BG003|Baseline|Total|Total of all reporting groups
10904705|NCT00587678|FG000|Participant Flow|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
10904706|NCT00587678|FG001|Participant Flow|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
10904707|NCT00587678|FG002|Participant Flow|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
11091066|NCT01532973|OG000|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
11091067|NCT01532973|OG001|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
11091068|NCT01532973|OG002|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
11091069|NCT01532973|OG003|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
11091070|NCT01532973|OG000|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
11091071|NCT01532973|OG001|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
11091072|NCT01532973|OG002|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
11091073|NCT01532973|OG000|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
11091074|NCT01532973|OG001|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
11091075|NCT01532973|OG002|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
11091076|NCT01532973|OG000|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
11091077|NCT01532973|OG001|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
11091078|NCT01532973|OG002|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
11091079|NCT01532973|OG003|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
11091080|NCT01532973|OG004|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
11091081|NCT01532973|OG004|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
11091082|NCT01532973|EG000|Reported Event|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
11091083|NCT01532973|EG001|Reported Event|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
11172185|NCT02007434|OG000|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
11172186|NCT02007434|OG001|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
11172187|NCT02007434|OG002|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
10904708|NCT00587678|OG000|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
10904709|NCT00587678|OG001|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
10904710|NCT00587678|OG002|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
10904711|NCT00587678|EG000|Reported Event|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
10904712|NCT00587678|EG001|Reported Event|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
10904713|NCT00587678|EG002|Reported Event|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
10904714|NCT00587769|BG000|Baseline|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
10904715|NCT00587769|FG000|Participant Flow|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
10904716|NCT00587769|OG000|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
10904717|NCT00587769|EG000|Reported Event|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
10904718|NCT00587834|BG000|Baseline|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
11091084|NCT01532973|EG002|Reported Event|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
11091085|NCT01532973|EG003|Reported Event|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
11091086|NCT01532973|EG004|Reported Event|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
11091087|NCT01532973|EG005|Reported Event|Post-Study|All participants who received 5, 10, 50, or 100 mg of elbasvir or placebo in treatment period of study
11091088|NCT01532986|BG000|Baseline|Usual Care (Arm 1)|"A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
11091089|NCT01532986|BG001|Baseline|Intervention (Arm 2)|"A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
11091090|NCT01532986|BG002|Baseline|Total|Total of all reporting groups
11091091|NCT01532986|FG000|Participant Flow|Usual Care (Arm 1)|"Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
11091092|NCT01532986|FG001|Participant Flow|Intervention (Arm 2)|"A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
11091093|NCT01532986|OG000|Outcome|Usual Care (Arm 1)|"Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
11091094|NCT01532986|OG001|Outcome|Intervention (Arm 2)|"A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
11091095|NCT01532986|OG000|Outcome|Usual Care (Arm 1)|"A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
11091096|NCT01532986|EG000|Reported Event|Usual Care (Arm 1)|"Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
11091097|NCT01532986|EG001|Reported Event|Intervention (Arm 2)|"A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.~Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook."
10904719|NCT00587834|FG000|Participant Flow|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
10904720|NCT00587834|OG000|Outcome|Gintuit|Single application;split-mouth design
10904721|NCT00587834|OG000|Outcome|Gintuit Equally Red as Adjacent Tissue|
10904722|NCT00587834|OG001|Outcome|Gintuit Not Equally Red as Adjacent Tissue|"Not Equally Red includes responses of more red and less red"
10904723|NCT00587834|OG000|Outcome|Gintuit Equally Firm as Adjacent Tissue|
10904724|NCT00587834|OG001|Outcome|Gintuit Not Equally Firm as Adjacent Tissue|"Not Equally Firm includes responses of less firm and more firm"
10904725|NCT00587834|OG000|Outcome|Gintuit|Single application of Gintuit and FGG (control); split-mouth design. Number of subjects preferring Gintuit over Control.
10904726|NCT00587834|OG000|Outcome|Gintuit Not Sensitive|Included ratings of None and Mild
10904727|NCT00587834|OG001|Outcome|Gintuit Sensitive|Included ratings of Moderate and Severe
10904728|NCT00587834|EG000|Reported Event|Gintuit|Adverse events occurring at the Gintuit treated site
10904729|NCT00587834|EG001|Reported Event|Free Gingival Graft|Adverse events occurring at the autologous free gingival graft site
10904730|NCT00587834|EG002|Reported Event|Palatal Donation Site|Adverse events occurring at the palatal donation site
10904731|NCT00587834|EG003|Reported Event|Mouth|Adverse events occurring in the mouth and not localized to the Gintuit, FGG, or palatal donation sites.
10904732|NCT00587834|EG004|Reported Event|Other|Adverse events occurring at any other location in the body or systemic conditions
10904733|NCT00587847|BG000|Baseline|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
10904734|NCT00587847|FG000|Participant Flow|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
10904735|NCT00587847|OG000|Outcome|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
10904736|NCT00587847|OG000|Outcome|All Participants|All participants were included in the safety analysis.
10904737|NCT00587847|EG000|Reported Event|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
10915005|NCT00633880|FG002|Participant Flow|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10915006|NCT00633880|OG000|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10915007|NCT00633880|OG001|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10915008|NCT00633880|EG000|Reported Event|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10915009|NCT00633880|EG001|Reported Event|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10915010|NCT00633880|EG002|Reported Event|Open Label Phase|All patient titrated on droxidopa during open-label phase
10915011|NCT00633893|BG000|Baseline|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
10915012|NCT00633893|BG001|Baseline|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
10915013|NCT00633893|BG002|Baseline|Placebo|Participants received matching placebo oral tablet BID.
10915014|NCT00633893|BG003|Baseline|Total|Total of all reporting groups
10915015|NCT00633893|FG000|Participant Flow|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban twice a day (BID)
10915016|NCT00633893|FG001|Participant Flow|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
10915017|NCT00633893|FG002|Participant Flow|Placebo|Participants received matching placebo oral tablet BID.
10915018|NCT00633893|OG000|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
10915019|NCT00633893|OG001|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
10915020|NCT00633893|OG002|Outcome|Placebo|Participants received matching placebo oral tablet BID.
10915021|NCT00633893|EG000|Reported Event|Apixaban 2.5mg|Participants received 2.5 mg oral tablet apixaban BID
10915022|NCT00633893|EG001|Reported Event|Apixaban 5mg|Participants received 5 mg oral tablet apixaban BID
10915023|NCT00633893|EG002|Reported Event|Placebo|Participants received oral tablet of placebo BID
10915024|NCT00633919|BG000|Baseline|Active|SLITone Dermatophagoides Mix
10915025|NCT00633919|BG001|Baseline|Placebo|SLITone Placebo
10915026|NCT00633919|BG002|Baseline|Total|Total of all reporting groups
10915027|NCT00633919|FG000|Participant Flow|Active|SLITone Dermatophagoides Mix
10915028|NCT00633919|FG001|Participant Flow|Placebo|SLITone Placebo
10915029|NCT00633919|OG000|Outcome|Active|SLITone Dermatophagoides Mix
10915030|NCT00633919|OG001|Outcome|Placebo|SLITone Placebo
10915031|NCT00633919|EG000|Reported Event|Active|SLITone Dermatophagoides Mix
10915032|NCT00633919|EG001|Reported Event|Placebo|SLITone Placebo
10915033|NCT00633932|BG000|Baseline|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
10915034|NCT00633932|BG001|Baseline|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
10915035|NCT00633932|BG002|Baseline|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
10915036|NCT00633932|BG003|Baseline|Total|Total of all reporting groups
10915037|NCT00633932|FG000|Participant Flow|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
10915038|NCT00633932|FG001|Participant Flow|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
10915039|NCT00633932|FG002|Participant Flow|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
10904738|NCT04545008|BG000|Baseline|Low Dose N-Acetyl Cysteine Alone|"N-Acetyl Cysteine 600 mg three times daily~N-Acetyl cysteine: Oral N-Acetyl Cysteine"
10904739|NCT04545008|FG000|Participant Flow|Low Dose N-Acetyl Cysteine Alone|"N-Acetyl Cysteine 600 mg three times daily~N-Acetyl cysteine: Oral N-Acetyl Cysteine"
10904740|NCT04545008|OG000|Outcome|Low Dose N-Acetyl Cysteine Alone|"N-Acetyl Cysteine 600 mg three times daily~N-Acetyl cysteine: Oral N-Acetyl Cysteine"
10904741|NCT04545008|EG000|Reported Event|Low Dose N-Acetyl Cysteine Alone|"N-Acetyl Cysteine 600 mg three times daily~N-Acetyl cysteine: Oral N-Acetyl Cysteine"
10904742|NCT04411680|BG000|Baseline|Sargramostim Arm|"Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19~Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.~Standard of care: Standard of care for COVID-19"
10904743|NCT04411680|BG001|Baseline|Control Arm|"Standard of care for COVID-19~Standard of care: Standard of care for COVID-19"
10904744|NCT04411680|BG002|Baseline|Total|Total of all reporting groups
10904745|NCT04411680|FG000|Participant Flow|Sargramostim Arm|"Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19~Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.~Standard of care: Standard of care for COVID-19"
10904746|NCT04411680|FG001|Participant Flow|Control Arm|"Standard of care for COVID-19~Standard of care: Standard of care for COVID-19"
10904747|NCT04411680|OG000|Outcome|Sargramostim Arm|"Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19~Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.~Standard of care: Standard of care for COVID-19"
10904748|NCT04411680|OG001|Outcome|Control Arm|"Standard of care for COVID-19~Standard of care: Standard of care for COVID-19"
10904749|NCT04411680|EG000|Reported Event|Sargramostim Arm|"Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19~Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.~Standard of care: Standard of care for COVID-19"
10904750|NCT04411680|EG001|Reported Event|Control Arm|"Standard of care for COVID-19~Standard of care: Standard of care for COVID-19"
10904751|NCT04364984|BG000|Baseline|ARB Group|Hypertensive patients with COVID-19 who received ARBs (valsartan 160-320 mg q.d. or olmesartan 20-40 mg q.d. or irbesartan 150-300 mg q.d. or candesartan 4-16 mg q.d.or losartan 50-100 mg q.d. in individual dosage) before and during COVID-19 for treatment of hypertension
10904752|NCT04364984|BG001|Baseline|ACEi Group|Hypertensive patients with COVID-19 who received ACEis (enalapril 10-20 mg q.d. or ramipril 5-10 mg q.d. or lisinopril 10-20 mg q.d. or perindopril 5-10 mg q.d. in individual regime) before and during COVID-19 for treatment of hypertension
10904753|NCT04364984|BG002|Baseline|DRi Group|Hypertensive patients with COVID-19 who received DRis (direct renin inhibitor rasilez in dosage 150-300 mg per day) before and during COVID-19 for treatment of hypertension
10904754|NCT04364984|BG003|Baseline|Total|Total of all reporting groups
10904755|NCT04364984|FG000|Participant Flow|Group 1: ARB Group|44 patients with COVID-19, hypertension 1-2 stages, who received ARB as main therapy for hypertension
10904756|NCT04364984|FG001|Participant Flow|Group 2: iACE Group|44 patients with COVID-19 and hypertension 1-2 stages, who received iACE as the main treatment for hypertensions
10904757|NCT04364984|FG002|Participant Flow|Group 3: DRI Group|31 patients with COVID-19, hypertension 1-2 stages, who received ARB as main therapy for hypertension
10904758|NCT04364984|OG000|Outcome|ARB Group|Hypertensive patients with COVID-19 who received ARBs
10904759|NCT04364984|OG001|Outcome|ACEi Group|"Hypertensive patients with COVID-19 who received ACEis~Angiotensin converting enzyme inhibitor: routine drug intake"
10904760|NCT04364984|OG002|Outcome|DRi Group|Hypertensive patients with COVID-19 who received DRis
10904761|NCT04364984|EG000|Reported Event|ARB Group|Hypertensive patients with COVID-19 who received ARBs
10904762|NCT04364984|EG001|Reported Event|ACEi Group|"Hypertensive patients with COVID-19 who received ACEis~Angiotensin converting enzyme inhibitor: routine drug intake"
10904763|NCT04364984|EG002|Reported Event|DRi Group|Hypertensive patients with COVID-19 who received DRis
10904764|NCT04363437|BG000|Baseline|Colchine|Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
10904765|NCT04363437|BG001|Baseline|Usual Care|Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
10904766|NCT04363437|BG002|Baseline|Total|Total of all reporting groups
10904767|NCT04363437|FG000|Participant Flow|Colchine|Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
10904768|NCT04363437|FG001|Participant Flow|Usual Care|Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
10904769|NCT04363437|OG000|Outcome|Colchine|Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
10904770|NCT04363437|OG001|Outcome|Usual Care|Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
10904771|NCT04363437|EG000|Reported Event|Colchine|Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
10915040|NCT00633932|OG000|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
10904772|NCT04363437|EG001|Reported Event|Usual Care|Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
10904773|NCT04346537|BG000|Baseline|INGEVITY+ Study Participants|Each participant was allowed to have up to 2 INGEVITY+ leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle).
10904774|NCT04346537|FG000|Participant Flow|INGEVITY+ Study Participants|Each participant was allowed to have up to 2 INGEVITY+ leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.
10904775|NCT04346537|OG000|Outcome|INGEVITY+ Leads|Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who were implanted or attempted with INGEVITY+ lead(s). Of the 109 enrolled participants, there were 200 leads (101 right atrial, 99 right ventricular) that met the eligibility criteria for inclusion in endpoint analyses.
10904776|NCT04346537|EG000|Reported Event|INGEVITY+ Study Participants|Each participant was allowed to have up to 2 INGEVITY+ leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.
10915041|NCT00633932|OG001|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
10915042|NCT00633932|OG002|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
10915043|NCT00633932|EG000|Reported Event|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
10915044|NCT00633932|EG001|Reported Event|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
10915045|NCT00633932|EG002|Reported Event|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
10915046|NCT00633945|BG000|Baseline|Lenalidomide|Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
10915047|NCT00633945|FG000|Participant Flow|Lenalidomide|Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
10915048|NCT00633945|OG000|Outcome|Lenalidomide|Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
10915049|NCT00633945|OG000|Outcome|Lenalidomide Responders|Response with CLASI
10915050|NCT00633945|OG001|Outcome|Lenalidomide Nonresponder|Lack of response with CLASI
10915051|NCT00633945|EG000|Reported Event|Group 1|Lenalidomide treated patients
10915052|NCT00633984|BG000|Baseline|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
10915053|NCT00633984|BG001|Baseline|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
10915054|NCT00633984|BG002|Baseline|Total|Total of all reporting groups
10915055|NCT00633984|FG000|Participant Flow|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
10915056|NCT00633984|FG001|Participant Flow|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
10915057|NCT00633984|OG000|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
10915058|NCT00633984|OG001|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
10915059|NCT00633984|EG000|Reported Event|Cognitive Behavioral Therapy + DCS|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
10915060|NCT00633984|EG001|Reported Event|Cognitive Behavioral Therapy + Placebo|Participants received Cognitive Behavioral Group Therapy and Placebo.
11172188|NCT02007434|OG003|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
10915061|NCT00634036|BG000|Baseline|Pioglitazone|pioglitazone: pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
10915062|NCT00634036|BG001|Baseline|Placebo|placebo: matching placebo (inert tablet)
10915063|NCT00634036|BG002|Baseline|Total|Total of all reporting groups
10915064|NCT00634036|FG000|Participant Flow|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
10915065|NCT00634036|FG001|Participant Flow|Placebo|matching placebo (inert tablet)
10915066|NCT00634036|OG000|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
10915067|NCT00634036|OG001|Outcome|Placebo|matching placebo (inert tablet)
10915068|NCT00634036|EG000|Reported Event|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
10915069|NCT00634036|EG001|Reported Event|Placebo|matching placebo (inert tablet)
10915070|NCT00634049|BG000|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
11172189|NCT02007434|OG004|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
11172190|NCT02007434|OG005|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172191|NCT02007434|OG006|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
10904777|NCT04033991|BG000|Baseline|Participants With mRCC and/or aRCC|Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this study. Data of these participants were derived from Christie NHS database.
10904778|NCT04033991|FG000|Participant Flow|Participants With mRCC and/or aRCC|Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this study. Data of these participants were derived from Christie NHS database.
10904779|NCT04033991|OG000|Outcome|Participants With mRCC and/or aRCC: First Line Sunitinib Treatment|Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
10904780|NCT04033991|OG001|Outcome|Participants With mRCC and/or aRCC: Second Line Axitinib Treatment|Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
10904781|NCT04033991|EG000|Reported Event|Participants With mRCC and/or aRCC: First Line Sunitinib Treatment|Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
10904782|NCT04033991|EG001|Reported Event|Participants With mRCC and/or aRCC: Second Line Axitinib Treatment|Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
10904783|NCT03930849|BG000|Baseline|AIMS Intervention|"Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.~AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame."
10904784|NCT03930849|BG001|Baseline|No Intervention|Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
10904785|NCT03930849|BG002|Baseline|AIMS Intervention Plus|"Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.~AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame."
10904786|NCT03930849|BG003|Baseline|Total|Total of all reporting groups
10904787|NCT03930849|FG000|Participant Flow|AIMS Intervention|"Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.~AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame."
10904788|NCT03930849|FG001|Participant Flow|No Intervention|Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
10904789|NCT03930849|FG002|Participant Flow|AIMS Intervention Plus|"Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.~AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame."
10904790|NCT03930849|OG000|Outcome|AIMS Intervention|"Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.~AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame."
10904791|NCT03930849|OG001|Outcome|No Intervention|Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
10904792|NCT03930849|OG002|Outcome|AIMS Intervention Plus|"Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.~AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame."
10904793|NCT03930849|EG000|Reported Event|AIMS Intervention|"Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.~AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame."
10904794|NCT03930849|EG001|Reported Event|No Intervention|Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
10904795|NCT03930849|EG002|Reported Event|AIMS Intervention Plus|"Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.~AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame."
10915071|NCT00634049|FG000|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
11172192|NCT02007434|OG007|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172193|NCT02007434|OG006|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 to 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172194|NCT02007434|EG000|Reported Event|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
11172195|NCT02007434|EG001|Reported Event|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
11172196|NCT02007434|EG002|Reported Event|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
11172197|NCT02007434|EG003|Reported Event|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172198|NCT02007434|EG004|Reported Event|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
11172199|NCT02007434|EG005|Reported Event|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172200|NCT02007434|EG006|Reported Event|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172201|NCT02007434|EG007|Reported Event|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
11172202|NCT02007577|BG000|Baseline|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
10904796|NCT03793439|BG000|Baseline|Open-label Treatment|"All subjects will receive tofacitinib 5mg twice daily from week 0 to week 16, and a corticosteroid taper starting at week 16. Participants also undergo spirometry, RNA sequence testing, and laboratory evaluations.~Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial: Tofacitinib 5mg oral table twice daily for 16 weeks~Spirometry: Spirometry testing at baseline, week 4, week 8, week 12, and week 16~RNA Sequencing: RNA sequencing test at baseline and week 16~Laboratory testing: Laboratory testing at baseline and weeks 2, 4, 8, 12 and 16~Corticosteroid: Taper corticosteroids starting at week 4~Tofacitinib 5mg [Xeljanz] 1 year open-label extension: After 16 weeks, subjects who meet the primary end-point will be permitted an optional one year open-label extension."
10904797|NCT03793439|FG000|Participant Flow|Open Label|Tofacitinib 5 mg twice daily by mouth
10904798|NCT03793439|OG000|Outcome|Open Label|open label tofacitinib
10904799|NCT03793439|EG000|Reported Event|Open Label|open label tofacitinib
10904800|NCT03711266|BG000|Baseline|PE-PC|"Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry.~PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks"
10904801|NCT03711266|FG000|Participant Flow|PE-PC|"Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry.~PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks"
10904802|NCT03711266|OG000|Outcome|PE-PC|"Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry.~PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks"
10904803|NCT03711266|EG000|Reported Event|PE-PC|"Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry.~PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks"
10904804|NCT03630393|BG000|Baseline|Pressure 6 mmHg|"Pneumoperitoneum Pressure 6 mmHg~Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP."
10904805|NCT03630393|BG001|Baseline|Pressure 15 mmHg|"Pneumoperitoneum Pressure 15 mmHg~Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP."
11172203|NCT02007577|BG001|Baseline|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
10904806|NCT03630393|BG002|Baseline|Total|Total of all reporting groups
10904807|NCT03630393|FG000|Participant Flow|Pressure 6 mmHg|"Pneumoperitoneum Pressure 6 mmHg~Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy."
10904808|NCT03630393|FG001|Participant Flow|Pressure 15 mmHg|"Pneumoperitoneum Pressure 15 mmHg~Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy."
10904809|NCT03630393|OG000|Outcome|Pressure 6 mmHg|"Pneumoperitoneum Pressure 6 mmHg~Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP."
10904810|NCT03630393|OG001|Outcome|Pressure 15 mmHg|"Pneumoperitoneum Pressure 15 mmHg~Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP."
10904811|NCT03630393|EG000|Reported Event|Pressure 6 mmHg|"Pneumoperitoneum Pressure 6 mmHg~Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy."
10904812|NCT03630393|EG001|Reported Event|Pressure 15 mmHg|"Pneumoperitoneum Pressure 15 mmHg~Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy."
10904813|NCT03531788|BG000|Baseline|Armon Ayura (Kinova)|"Participants will trial the Armon Ayura dynamic arm support.~Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm)"
10904814|NCT03531788|BG001|Baseline|JAECO WREX|"Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.~JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)"
10904815|NCT03531788|BG002|Baseline|Total|Total of all reporting groups
10904816|NCT03531788|FG000|Participant Flow|Armon Ayura (Kinova)|"Participants will trial the Armon Ayura dynamic arm support.~Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm)"
10904817|NCT03531788|FG001|Participant Flow|JAECO WREX|"Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.~JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)"
10904818|NCT03531788|OG000|Outcome|Armon Ayura (Kinova)|"Participants will trial the Armon Ayura dynamic arm support.~Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm)"
10904819|NCT03531788|OG001|Outcome|JAECO WREX|"Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.~JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)"
10904820|NCT03531788|EG000|Reported Event|Armon Ayura (Kinova)|"Participants will trial the Armon Ayura dynamic arm support.~Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm)"
11172204|NCT02007577|BG002|Baseline|Total|Total of all reporting groups
11172205|NCT02007577|FG000|Participant Flow|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
11172206|NCT02007577|FG001|Participant Flow|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
10904821|NCT03531788|EG001|Reported Event|JAECO WREX|"Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.~JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)"
10904822|NCT03359811|BG000|Baseline|Standard-of-Care Thoracic Epidural Analgesia (TEA)|Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
10904823|NCT03359811|BG001|Baseline|Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block|Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.
10904824|NCT03359811|BG002|Baseline|Total|Total of all reporting groups
10904825|NCT03359811|FG000|Participant Flow|Standard-of-Care Thoracic Epidural Analgesia (TEA)|Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
10904826|NCT03359811|FG001|Participant Flow|Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block|Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.
10904827|NCT03359811|OG000|Outcome|Standard-of-Care Thoracic Epidural Analgesia (TEA)|Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
10904828|NCT03359811|OG001|Outcome|Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block|Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.
10904829|NCT03359811|OG001|Outcome|4Q-TAP Blocks|Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.
10904830|NCT03359811|EG000|Reported Event|Standard-of-Care Thoracic Epidural Analgesia (TEA)|Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
10904831|NCT03359811|EG001|Reported Event|Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block|Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.
10915072|NCT00634049|OG000|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
10915073|NCT00634049|OG001|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
10915074|NCT00634049|OG002|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
11172207|NCT02007577|OG000|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
10904832|NCT03241589|BG000|Baseline|Rural Veterans|"Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas.~Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app. The two arms occur simultaneously."
10904833|NCT03241589|BG001|Baseline|Nonrural Veterans|"Originally VA sites to eventually receive the direct to patient facing apps but at present had not were in the second arm or control group. Since our enrollment at the facility level was low, this arm now consists of Veterans living in nonrural areas.~Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app. The two arms occur simultaneously."
10904834|NCT03241589|BG002|Baseline|Total|Total of all reporting groups
10904835|NCT03241589|FG000|Participant Flow|Rural Veterans|"Originally the aim was to include VA sites who received the direct to patient facing app from Office of Connected Care (OCC). Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas.~Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app. The two arms occur simultaneously."
10904836|NCT03241589|FG001|Participant Flow|Nonrural Veterans|"Originally VA sites to eventually receive the direct to patient facing apps but at present had not were in the second arm or control group. Since our enrollment at the facility level was low, this arm now consists of Veterans living in nonrural areas.~Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app. The two arms occur simultaneously."
10904837|NCT03241589|OG000|Outcome|Rural Veterans|"Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans with living in rural areas.~Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app."
11172208|NCT02007577|OG001|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
11172209|NCT02007577|EG000|Reported Event|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
11172210|NCT02007577|EG001|Reported Event|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
11172211|NCT02007720|BG000|Baseline|Placebo|Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
11172212|NCT02007720|BG001|Baseline|Serelaxin|Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
11172213|NCT02007720|BG002|Baseline|Total|Total of all reporting groups
11172214|NCT02007720|FG000|Participant Flow|Placebo|Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
11172215|NCT02007720|FG001|Participant Flow|Serelaxin|Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
11172216|NCT02007720|OG000|Outcome|Placebo|Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
11172217|NCT02007720|OG001|Outcome|Serelaxin|Patients who receivedcontinuous intravenous infusion of serelaxin for 48 hours.
11172218|NCT02007720|EG000|Reported Event|RLX030|RLX030
10904838|NCT03241589|OG001|Outcome|Nonrural Veterans|"Originally VA sites to eventually receive the direct to patient facing apps but at present had not were in the second arm or control group. Since our enrollment at the facility level was low, this arm now consists of Veterans living in nonrural areas.~Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app."
10904839|NCT03241589|OG000|Outcome|Rural Veterans|The first group is defined as Veterans living in rural areas receiving a request to use the patient facing app.
10904840|NCT03241589|OG001|Outcome|Nonrural Veterans|This group consists of Veterans receiving a request to use the patient facing app, living in nonrural areas.
10904841|NCT03241589|EG000|Reported Event|Rural Veterans|"Rural Veterans use of OCC's direct to patient facing mobile app.~Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas."
10904842|NCT03241589|EG001|Reported Event|Nonrural Veterans|"Nonrural Veterans use of OCC's direct to patient facing mobile app.~Originally VA sites to eventually receive the direct to patient facing apps but at present had not were in the second arm or control group. Since our enrollment at the facility level was low, this arm now consists of Veterans living in nonrural areas."
10904843|NCT02959775|BG000|Baseline|IM20 Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10904844|NCT02959775|BG001|Baseline|IM60 Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10904845|NCT02959775|BG002|Baseline|Blank Control Group|Participants received no intervention.
10904846|NCT02959775|BG003|Baseline|Total|Total of all reporting groups
10904847|NCT02959775|FG000|Participant Flow|IM20 Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10904848|NCT02959775|FG001|Participant Flow|IM60 Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10904849|NCT02959775|FG002|Participant Flow|Blank Control Group|Participants received no intervention.
10904850|NCT02959775|OG000|Outcome|IM20 Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
11172219|NCT02007720|EG001|Reported Event|Placebo|Patients who received continuous intravenous infusion of matching placebo serelaxin for 48 hours.
11172220|NCT02007720|EG002|Reported Event|Total|Total
10904851|NCT02959775|OG001|Outcome|IM60 Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10904852|NCT02959775|OG002|Outcome|Blank Control Group|Participants received no intervention
10904853|NCT02959775|OG002|Outcome|Blank Control Group|Participants received no intervention.
10904854|NCT02959775|OG002|Outcome|Control|Participants received no intervention.
10904855|NCT02959775|EG000|Reported Event|IM20 Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
11172221|NCT02007863|BG000|Baseline|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -13 through -9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days -4 through -2 for a total of 3 doses."
11172222|NCT02007863|FG000|Participant Flow|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -13 through -9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days -4 through -2 for a total of 3 doses."
11172223|NCT02007863|OG000|Outcome|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -13 through -9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days -4 through -2 for a total of 3 doses."
11172224|NCT02007863|EG000|Reported Event|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -13 through -9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days -4 through -2 for a total of 3 doses."
11172225|NCT02007954|BG000|Baseline|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
11342291|NCT03704194|EG000|Reported Event|Adapted LiFE|"Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar."
10904856|NCT02959775|EG001|Reported Event|IM60 Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10904857|NCT02954406|BG000|Baseline|Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904858|NCT02954406|BG001|Baseline|Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2|TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904859|NCT02954406|BG002|Baseline|Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2|TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10915197|NCT00634543|OG000|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
10904860|NCT02954406|BG003|Baseline|Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904861|NCT02954406|BG004|Baseline|Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904862|NCT02954406|BG005|Baseline|Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904863|NCT02954406|BG006|Baseline|Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.
10904864|NCT02954406|BG007|Baseline|Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg|TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904865|NCT02954406|BG008|Baseline|Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904866|NCT02954406|BG009|Baseline|Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
10904867|NCT02954406|BG010|Baseline|Total|Total of all reporting groups
10904868|NCT02954406|FG000|Participant Flow|Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced progressive disease (PD) or unacceptable toxicities or up to 39 cycles.
10904869|NCT02954406|FG001|Participant Flow|Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2|TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904870|NCT02954406|FG002|Participant Flow|Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2|TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904871|NCT02954406|FG003|Participant Flow|Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904872|NCT02954406|FG004|Participant Flow|Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10915198|NCT00634543|OG001|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
10904873|NCT02954406|FG005|Participant Flow|Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904874|NCT02954406|FG006|Participant Flow|Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.
10904875|NCT02954406|FG007|Participant Flow|Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg|TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904876|NCT02954406|FG008|Participant Flow|Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904877|NCT02954406|FG009|Participant Flow|Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
10904878|NCT02954406|FG010|Participant Flow|Safety Expansion Phase Cohort B: TAK-659 + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 immediate-release tablet, at the MTD/maximally administered dose (MAD)/RP2D determined from Dose Escalation Phase, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles in participants (who were to be entered in Phase 2) with advanced follicular lymphoma (FL) or marginal zone lymphoma (MZL). Treatment could then be continued until they experienced PD or unacceptable toxicities in participants who were to be enrolled in the Safety Expansion Phase Cohort.
10904879|NCT02954406|OG000|Outcome|Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2|TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904880|NCT02954406|OG001|Outcome|Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904881|NCT02954406|OG002|Outcome|Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.
10904882|NCT02954406|OG003|Outcome|Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg|TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904883|NCT02954406|OG004|Outcome|Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
10904884|NCT02954406|OG000|Outcome|Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced progressive disease (PD) or unacceptable toxicities or up to 39 cycles.
10904885|NCT02954406|OG001|Outcome|Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2|TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904886|NCT02954406|OG002|Outcome|Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2|TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904887|NCT02954406|OG003|Outcome|Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904888|NCT02954406|OG004|Outcome|Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904889|NCT02954406|OG005|Outcome|Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904890|NCT02954406|OG006|Outcome|Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.
10904891|NCT02954406|OG007|Outcome|Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg|TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904892|NCT02954406|OG008|Outcome|Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904893|NCT02954406|OG009|Outcome|Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
10904894|NCT02954406|OG000|Outcome|Safety Expansion Phase Cohort B: TAK-659 + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 immediate-release tablet, at the MTD/maximally administered dose (MAD)/RP2D determined from Dose Escalation Phase, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles in participants (who were to be entered in Phase 2) with advanced follicular lymphoma (FL) or marginal zone lymphoma (MZL). Treatment could then be continued until they experienced PD or unacceptable toxicities in participants who were to be enrolled in the Safety Expansion Phase Cohort.
10904895|NCT02954406|EG000|Reported Event|Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904896|NCT02954406|EG001|Reported Event|Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2|TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904897|NCT02954406|EG002|Reported Event|Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2|TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.
10904898|NCT02954406|EG003|Reported Event|Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904899|NCT02954406|EG004|Reported Event|Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904900|NCT02954406|EG005|Reported Event|Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2|TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
10904901|NCT02954406|EG006|Reported Event|Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.
10904902|NCT02954406|EG007|Reported Event|Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg|TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904903|NCT02954406|EG008|Reported Event|Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.
10904904|NCT02954406|EG009|Reported Event|Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg|TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
10904905|NCT02927145|BG000|Baseline|Group 1|The study is designed to assess a 'standard' protein-in-adjuvant vaccination regimen- 2µg RH5.1/ 0.5mL AS01- of 3 doses given four weeks apart, with dose escalation to assess the best dose in healthy adults.
11342292|NCT03704194|EG001|Reported Event|Attention Control|"Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.~Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest."
10904906|NCT02927145|BG001|Baseline|Group 2|"The dose used will be- 10µg RH5.1/ 0.5mL AS01. The total number of volunteers recruited to Groups 1 and 2 will be decided based on the immunogenicity of the vaccines at the 2 µg and 10 µg doses.~If the doses are immunogenic the groups (1 and 2) will be recruited to a total of 12 volunteers.~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904907|NCT02927145|BG002|Baseline|Group 3|"Group 3 will receive 50µg RH5.1/ 0.5mL AS0 The ultimate aim is to assess the safety and immunogenicity of giving the 'standard' first two doses of the vaccine followed by a delayed fractional dose (10 µg).~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904908|NCT02927145|BG003|Baseline|Group 4|"Group 3 and 4 will be recruited simultaneously. The dose of vaccine for this group is same as that of 3 (50µg RH5.1/ 0.5mL AS01) RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904909|NCT02927145|BG004|Baseline|Group 5|"The vaccination dose for Group 5 was decided following the analysis of safety and exploratory immunology assays from Groups 1, 2 and 4. The dose of vaccine for this group is the same as that of group 2 (10µg RH5.1/ 0.5mL AS01).~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity.~Note, group 7 constitutes volunteers from groups 5 so is not presented separately"
10904910|NCT02927145|BG005|Baseline|Group 6|"Group 6 volunteers will be infectivity controls, so will not receive any vaccinations.~Groups 5 and 6 will only be recruited once at least 6 volunteers in Group 4 have completed all vaccinations.~Note, group 8 constitutes volunteers from groups 6 so is not presented separately"
10904911|NCT02927145|BG006|Baseline|Group 9|Group 9 are new infectivity controls
10904912|NCT02927145|BG007|Baseline|Total|Total of all reporting groups
10904913|NCT02927145|FG000|Participant Flow|Group 1-Phase Ia|"The study is designed to assess a 'standard' protein-in-adjuvant vaccination regimen- 2µg RH5.1/ 0.5mL AS01- of 3 doses given four weeks apart, with dose escalation to assess the best dose in healthy adults.~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904914|NCT02927145|FG001|Participant Flow|Group 2- Phase Ia|"The dose used will be- 10µg RH5.1/ 0.5mL AS01. The total number of volunteers recruited to Groups 1 and 2 will be decided based on the immunogenicity of the vaccines at the 2 µg and 10 µg doses.~If the doses are immunogenic the groups (1 and 2) will be recruited to a total of 12 volunteers.~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904915|NCT02927145|FG002|Participant Flow|Group 3-Phase Ia|"Group 3 will receive 50µg RH5.1/ 0.5mL AS0~The ultimate aim is to assess the safety and immunogenicity of giving the 'standard' first two doses of the vaccine followed by a delayed fractional dose (10 µg).~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904916|NCT02927145|FG003|Participant Flow|Group 4-Phase Ia|"Group 3 and 4 will be recruited simultaneously. The dose of vaccine for this group is same as that of 3 (50µg RH5.1/ 0.5mL AS01)~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904917|NCT02927145|FG004|Participant Flow|Group 5-Phase IIa|"The vaccination dose for Group 5 was decided following the analysis of safety and exploratory immunology assays from Groups 1, 2 and 4. The dose of vaccine for this group is the same as that of group 2 (10µg RH5.1/ 0.5mL AS01).~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904918|NCT02927145|FG005|Participant Flow|Group 6-Phase IIa|"Group 6 volunteers will be infectivity controls, so will not receive any vaccinations.~Groups 5 and 6 will only be recruited once at least 6 volunteers in Group 4 have completed all vaccinations."
11172226|NCT02007954|FG000|Participant Flow|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
11172227|NCT02007954|OG000|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
11172228|NCT02007954|EG000|Reported Event|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
11172229|NCT02008149|BG000|Baseline|FES-Rowers|Individuals with complete SCI participating in a 90-session FES-rowing program.
10904919|NCT02927145|FG006|Participant Flow|Group 7-Phase IIa|"Group 7 are Group 5 volunteers who will receive a fourth dose of IMP (10µg RH5.1/ 0.5mL AS01)~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904920|NCT02927145|FG007|Participant Flow|Group 8 -Phase IIa|Group 8 are infectivity controls who were originally in Group 6.
11172230|NCT02008149|BG001|Baseline|Standard-of-Care Controls|Individuals with complete SCI undergoing bone density scanning at four time points over 9 months.
11172231|NCT02008149|BG002|Baseline|Experienced FES-Rower|An individual with more than 10 years of FES-Rowing experience.
11172232|NCT02008149|BG003|Baseline|Total|Total of all reporting groups
11172233|NCT02008149|FG000|Participant Flow|FES-Rowers|Individuals with complete SCI participating in a 90-session FES-rowing program.
10904921|NCT02927145|FG008|Participant Flow|Group 9 -Phase IIa|Group 9 are new infectivity controls
10904922|NCT02927145|OG000|Outcome|Group 1-Phase Ia|"The study is designed to assess a 'standard' protein-in-adjuvant vaccination regimen- 2µg RH5.1/ 0.5mL AS01- of 3 doses given four weeks apart, with dose escalation to assess the best dose in healthy adults.~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
11172234|NCT02008149|FG001|Participant Flow|Standard-of-Care Controls|Individuals with complete SCI undergoing bone density scanning at four time points over 9 months.
11172235|NCT02008149|FG002|Participant Flow|Experienced FES-Rower|An individual with more than 10 years of FES-Rowing experience.
11172236|NCT02008149|OG000|Outcome|FES-Rowers|Individuals with complete SCI participating in a 90-session FES-rowing program.
11172237|NCT02008149|OG001|Outcome|Standard-of-Care Controls|Individuals with complete SCI undergoing bone density scanning at four time points over 9 months.
11172238|NCT02008149|OG002|Outcome|Experienced FES-Rower|An individual with more than 10 years of FES-Rowing experience.
11172239|NCT02008149|EG000|Reported Event|FES-Rowers|Individuals with complete SCI participating in a 90-session FES-rowing program.
11172240|NCT02008149|EG001|Reported Event|Standard-of-Care Controls|Individuals with complete SCI undergoing bone density scanning at four time points over 9 months.
11172241|NCT02008149|EG002|Reported Event|Experienced FES-Rower|An individual with more than 10 years of FES-Rowing experience.
11172242|NCT02008227|BG000|Baseline|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
11172243|NCT02008227|BG001|Baseline|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
11172244|NCT02008227|BG002|Baseline|Total|Total of all reporting groups
11172245|NCT02008227|FG000|Participant Flow|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
11172246|NCT02008227|FG001|Participant Flow|Atezolizumab|Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
10904923|NCT02927145|OG001|Outcome|Group 2- Phase Ia|"The dose used will be- 10µg RH5.1/ 0.5mL AS01. The total number of volunteers recruited to Groups 1 and 2 will be decided based on the immunogenicity of the vaccines at the 2 µg and 10 µg doses.~If the doses are immunogenic the groups (1 and 2) will be recruited to a total of 12 volunteers.~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904924|NCT02927145|OG002|Outcome|Group 3-Phase Ia|"Group 3 will receive 50µg RH5.1/ 0.5mL AS0~The ultimate aim is to assess the safety and immunogenicity of giving the 'standard' first two doses of the vaccine followed by a delayed fractional dose (10 µg).~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904925|NCT02927145|OG003|Outcome|Group 4-Phase Ia|"Group 3 and 4 will be recruited simultaneously. The dose of vaccine for this group is same as that of 3 (50µg RH5.1/ 0.5mL AS01)~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904926|NCT02927145|OG004|Outcome|Group 5-Phase IIa|"The vaccination dose for Group 5 was decided following the analysis of safety and exploratory immunology assays from Groups 1, 2 and 4. The dose of vaccine for this group is the same as that of group 2 (10µg RH5.1/ 0.5mL AS01).~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904927|NCT02927145|OG005|Outcome|Group 6-Phase IIa|"Group 6 volunteers will be infectivity controls, so will not receive any vaccinations.~Groups 5 and 6 will only be recruited once at least 6 volunteers in Group 4 have completed all vaccinations."
10904928|NCT02927145|OG006|Outcome|Group 7-Phase IIa|"Group 7 are Group 5 volunteers who will receive a fourth dose of IMP (10µg RH5.1/ 0.5mL AS01)~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
10904929|NCT02927145|OG007|Outcome|Group 8 -Phase IIa|Group 8 are infectivity controls who were originally in Group 6.
10904930|NCT02927145|OG008|Outcome|Group 9 -Phase IIa|Group 9 are new infectivity controls
10904931|NCT02927145|OG005|Outcome|Group 7-Phase IIa|"Group 7 are Group 5 volunteers who will receive a fourth dose of IMP (10µg RH5.1/ 0.5mL AS01)~RH5.1/ ASO1: The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
11091098|NCT01532999|BG000|Baseline|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
11091099|NCT01532999|BG001|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
11091100|NCT01532999|BG002|Baseline|Total|Total of all reporting groups
11091101|NCT01532999|FG000|Participant Flow|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
11091102|NCT01532999|FG001|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
10904932|NCT02927145|EG000|Reported Event|Group 1|3 doses of 2µg RH5.1 in 0.5mL AS01 at days 0, 28 and 56
10904933|NCT02927145|EG001|Reported Event|Group 2|3 doses of 10µg RH5.1 in 0.5mL AS01 at days 0, 28 and 56
10904934|NCT02927145|EG002|Reported Event|Group 3|2 doses of 50µg RH5.1 in 0.5mL AS01 at days 0 and 28, followed by 10µg RH5.1 in 0.5mL AS01 at day 182
10904935|NCT02927145|EG003|Reported Event|Group 4|3 doses of 50µg RH5.1 in 0.5mL AS01 at days 0, 28 and 56
10904936|NCT02927145|EG004|Reported Event|Group 5|3 doses of 10 µg RH5.1 in 0.5mL AS01 at days 0, 28 and 56
10904937|NCT02927145|EG005|Reported Event|Group 6|Primary CHMI controls
10904938|NCT02927145|EG006|Reported Event|Group 7|Group 5 participants receiving 1 further dose of 10 µg RH5.1 in 0.5 mL AS01 approximately 4 months after the last immunisation
10904939|NCT02927145|EG007|Reported Event|Group 8|Secondary CHMI controls
10904940|NCT02927145|EG008|Reported Event|Group 9|Primary CHMI controls
10904941|NCT02910583|BG000|Baseline|FD Cohort: All Treated|Participants received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until PD or unacceptable toxicity.
11091103|NCT01532999|OG000|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
11091104|NCT01532999|OG001|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
11091105|NCT01532999|EG000|Reported Event|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
11233410|NCT02427646|BG000|Baseline|Essential Tremor Treatment|IncobotulinumtoxinA: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
10904942|NCT02910583|BG001|Baseline|MRD Cohort: All Treated|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904943|NCT02910583|BG002|Baseline|Total|Total of all reporting groups
10904944|NCT02910583|FG000|Participant Flow|Fixed Duration (FD) Cohort: All Treated|Participants received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until disease progression or unacceptable toxicity.
10904945|NCT02910583|FG001|Participant Flow|Minimal Residual Disease (MRD) Cohort: All Treated|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904946|NCT02910583|OG000|Outcome|MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded)|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity.
10904947|NCT02910583|OG001|Outcome|MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded)|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity.
10904948|NCT02910583|OG000|Outcome|FD Cohort, Non-Del 17p Population: All Treated|Participants in the FD cohort without del 17p abnormality (according to non-missing baseline fluorescent in situ hybridization [FISH] results) received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until PD or unacceptable toxicity.
10904949|NCT02910583|OG001|Outcome|FD Cohort: All Treated|Participants received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until PD or unacceptable toxicity.
10904950|NCT02910583|OG000|Outcome|MRD Cohort: All Treated|"Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase).~Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity.~Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until clinical PD or unacceptable toxicity. If venetoclax were to be reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) until PD or unacceptable toxicity."
10904951|NCT02910583|OG001|Outcome|MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded)|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity.
10904952|NCT02910583|OG002|Outcome|MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded)|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity.
10904953|NCT02910583|OG003|Outcome|MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904954|NCT02910583|OG004|Outcome|MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. Venetoclax was allowed for administration up to 2 years cumulatively from first dose started in the pre-randomization phase to last dose in the randomization phase.
10904955|NCT02910583|OG000|Outcome|MRD Cohort: All Treated|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904956|NCT02910583|OG004|Outcome|MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until clinical PD or unacceptable toxicity. Venetoclax was allowed for administration up to 2 years cumulatively from first dose started in the pre-randomization phase to last dose in the randomization phase.
10904957|NCT02910583|OG000|Outcome|MRD Cohort: All Treated|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until clinical PD or unacceptable toxicity. If venetoclax were to be reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) until PD or unacceptable toxicity.
10904958|NCT02910583|OG004|Outcome|MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed are randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg tablets orally once daily on a continuous schedule until PD or unacceptable toxicity. Venetoclax was allowed for administration up to 2 years cumulatively from first dose started in the pre-randomization phase to last dose in the randomization phase.
11172247|NCT02008227|OG000|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
11172248|NCT02008227|OG001|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
11172249|NCT02008227|OG000|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
11172250|NCT02008227|EG000|Reported Event|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
11172251|NCT02008227|EG001|Reported Event|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
11172252|NCT02008318|BG000|Baseline|Galunisertib at 150 mg|Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines.
11172253|NCT02008318|BG001|Baseline|Galunisertib at 80 mg|Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines.
11172254|NCT02008318|BG002|Baseline|Total|Total of all reporting groups
11172255|NCT02008318|FG000|Participant Flow|Galunisertib at 150 mg|Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles).
10904959|NCT02910583|OG000|Outcome|MRD Cohort: All Treated|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until clinical PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg tablets orally once daily on a continuous schedule until PD or unacceptable toxicity.
10915199|NCT00634543|EG000|Reported Event|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
11172256|NCT02008318|FG001|Participant Flow|Galunisertib at 80 mg|Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles).
11172257|NCT02008318|OG000|Outcome|Galunisertib at 150 mg|Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines.
11172258|NCT02008318|OG001|Outcome|Arm: Galunisertib at 80 mg|Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14... more days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.
11172259|NCT02008318|OG001|Outcome|Galunisertib at 80 mg|Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14... more days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.
11172260|NCT02008318|OG001|Outcome|Galunisertib at 80 mg|Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines.
11172261|NCT02008318|OG000|Outcome|Galunisertib|Galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles).
11172262|NCT02008318|EG000|Reported Event|Galunisertib at 150 mg|Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles).
11172263|NCT02008318|EG001|Reported Event|Galunisertib at 80 mg|Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles).
11172264|NCT02008526|BG000|Baseline|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
11172265|NCT02008526|BG001|Baseline|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
11172266|NCT02008526|BG002|Baseline|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
11172267|NCT02008526|BG003|Baseline|Total|Total of all reporting groups
11174205|NCT02020278|OG000|Outcome|Optional Tolvaptan Treatment Component|The duration for the optional tolvaptan treatment (referred to as optional tolvaptan treatment component) was case-specific. It could have been short-term or long-term and could have consisted of 1 or more treatment cycles. Eligibility for optional tolvaptan treatment was to be determined at the pretreatment baseline visit of each dosing cycle. Each tolvaptan treatment cycle was to include a titration phase of up to 4 days and interruption of tolvaptan for up to 2 doses after 30 (±1) days of tolvaptan treatment.
10904960|NCT02910583|OG001|Outcome|MRD Cohort/uMRD Not Confirmed: All Participants|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904961|NCT02910583|OG002|Outcome|MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904962|NCT02910583|OG003|Outcome|MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed are randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. Venetoclax was allowed for administration up to 2 years cumulatively from first dose started in the pre-randomization phase to last dose in the randomization phase.
10904963|NCT02910583|OG000|Outcome|MRD Cohort: All Treated|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until clinical PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904964|NCT02910583|OG004|Outcome|MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax|Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed are randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. Venetoclax was allowed for administration up to 2 years cumulatively from first dose started in the pre-randomization phase to last dose in the randomization phase.
10904965|NCT02910583|OG000|Outcome|FD Cohort, Non-Del 17p Population: All Treated|Participants in the FD cohort without del 17p abnormality (according to non-missing baseline FISH results) received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until PD or unacceptable toxicity.
10904966|NCT02910583|OG000|Outcome|FD Cohort: All Treated|Participants received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until PD or unacceptable toxicity.
10904967|NCT02910583|EG000|Reported Event|Fixed Duration Cohort: Overall Study|Participants in the Fixed Duration Cohort received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until PD or unacceptable toxicity.
10904968|NCT02910583|EG001|Reported Event|MRD Cohort: All Participants Pre-Randomization|Participants in the MRD Cohort received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase).
11174206|NCT02020278|OG000|Outcome|Core Safety Follow-up Component|The core safety follow-up component of the trial was a 6-month period in which pediatric participants (children and adolescents) with dilutional (euvolemic or hypervolemic) hyponatremia, who previously participated in a tolvaptan hyponatremia trial, were to be followed (at a clinical trial site and/or through telephone calls), regardless of the need for treatment for hyponatremia, to assess the long-term safety of tolvaptan.
10904969|NCT02910583|EG002|Reported Event|MRD Cohort: All Participants Overall Study|Participants in the MRD Cohort received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904970|NCT02910583|EG003|Reported Event|MRD Cohort: Confirmed uMRD (IbrVen->Ibr) Pre-Randomization|Participants in the MRD Cohort with confirmed uMRD received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase).
10904971|NCT02910583|EG004|Reported Event|MRD Cohort: Confirmed uMRD (IbrVen->Ibr) Overall Study|Participants in the MRD Cohort with confirmed uMRD received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (prerandomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, clinical PD, or unacceptable toxicity.
10904972|NCT02910583|EG005|Reported Event|MRD Cohort: Confirmed uMRD (IbrVen->Pbo) Pre-Randomization|Participants in the MRD Cohort with confirmed uMRD received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase).
10904973|NCT02910583|EG006|Reported Event|MRD Cohort: Confirmed uMRD (IbrVen->Pbo) Overall Study|Participants in the MRD Cohort with confirmed uMRD received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, clinical PD or unacceptable toxicity.
10904974|NCT02910583|EG007|Reported Event|MRD Cohort: uMRD Not Confirmed (IbrVen->Ibr) Pre-Randomization|Participants in the MRD Cohort with uMRD not confirmed received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase).
10904975|NCT02910583|EG008|Reported Event|MRD Cohort: uMRD Not Confirmed (IbrVen->Ibr) Overall Study|Participants in the MRD Cohort with uMRD not confirmed received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904976|NCT02910583|EG009|Reported Event|MRD Cohort: uMRD Not Confirmed (IbrVen->IbrVen) Pre-Randomization|Participants in the MRD Cohort with uMRD not confirmed received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase).
10904977|NCT02910583|EG010|Reported Event|MRD Cohort: uMRD Not Confirmed (IbrVen->IbrVen) Overall Study|Participants in the MRD Cohort with uMRD not confirmed received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.
10904978|NCT02699060|BG000|Baseline|Non Erosive Reflux Disease|Participants not received drugs
10904979|NCT02699060|BG001|Baseline|Erosive Esophagitis|Participants not received drugs
10904980|NCT02699060|BG002|Baseline|Barrett's Esophagus|Participants not received drugs
10904981|NCT02699060|BG003|Baseline|Total|Total of all reporting groups
10904982|NCT02699060|FG000|Participant Flow|GERD|NERD patients, EE patients and BE patients
11172268|NCT02008526|FG000|Participant Flow|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
11172269|NCT02008526|FG001|Participant Flow|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
11172270|NCT02008526|FG002|Participant Flow|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
11172271|NCT02008526|OG000|Outcome|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
11357460|NCT03757234|FG002|Participant Flow|Omadacycline 200 iv/300 po or 100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
10904983|NCT02699060|OG000|Outcome|NERD Patients|Patients with heartburn were found to exhibit inflammatory esophageal mucosa during endoscopy
10904984|NCT02699060|OG001|Outcome|EE Patients|Patients with erosions or ulcers in esophagus by endoscopy
10904985|NCT02699060|OG002|Outcome|BE Patients|Patients with intestinal metaplasia in esophagus
10904986|NCT02699060|EG000|Reported Event|NERD Patients|Patients have the typical reflux syndrome without esophageal injury.
10904987|NCT02699060|EG001|Reported Event|EE Patients|Patients have erosion(s) or ulcer(s) in esophagus.
10904988|NCT02699060|EG002|Reported Event|BE Patients|Patients have specialized esophageal intestinal metaplasia.
10904989|NCT02598388|BG000|Baseline|Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)|Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10904990|NCT02598388|BG001|Baseline|Part 1: Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10904991|NCT02598388|BG002|Baseline|Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)|Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10904992|NCT02598388|BG003|Baseline|Part 1: Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10904993|NCT02598388|BG004|Baseline|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)|Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
11172272|NCT02008526|OG001|Outcome|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
11172273|NCT02008526|OG002|Outcome|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
11172274|NCT02008526|EG000|Reported Event|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
11172275|NCT02008526|EG001|Reported Event|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
11172276|NCT02008526|EG002|Reported Event|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
11172277|NCT02008565|BG000|Baseline|Loperamide - Exercise Plus Biofeedback|Participants receive loperamide drug and anal exercises with biofeedback intervention.
11172278|NCT02008565|BG001|Baseline|Placebo - Exercise Plus Biofeedback|Participants receive placebo drug and anal exercises with biofeedback intervention.
11172279|NCT02008565|BG002|Baseline|Loperamide - Education Only|Participants receive loperamide drug and educational pamphlet (usual care).
11172280|NCT02008565|BG003|Baseline|Placebo - Education Only|Participants receive placebo drug and educational pamphlet (usual care).
11172281|NCT02008565|BG004|Baseline|Total|Total of all reporting groups
11172282|NCT02008565|FG000|Participant Flow|Loperamide - Exercise Plus Biofeedback|Participants receive loperamide drug and anal exercise with biofeedback intervention.
11172283|NCT02008565|FG001|Participant Flow|Placebo - Exercise Plus Biofeedback|Participants receive placebo drug and anal exercise with biofeedback intervention.
11172284|NCT02008565|FG002|Participant Flow|Loperamide - Education Only|Participants receive loperamide drug and educational pamphlet (usual care).
11172285|NCT02008565|FG003|Participant Flow|Placebo - Education Only|Participants receive placebo drug and educational pamphlet (usual care).
11172286|NCT02008565|OG000|Outcome|Loperamide - Exercise Plus Biofeedback|Participants receive loperamide drug and anal exercises with biofeedback intervention.
11172287|NCT02008565|OG001|Outcome|Placebo - Exercise Plus Biofeedback|Participants receive placebo drug and anal exercises with biofeedback intervention.
11172288|NCT02008565|OG002|Outcome|Loperamide - Education Only|Participants receive loperamide drug and educational pamphlet (usual care).
10904994|NCT02598388|BG005|Baseline|Part 2 (Group 1): Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10904995|NCT02598388|BG006|Baseline|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10904996|NCT02598388|BG007|Baseline|Part 2 (Group 1): Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10904997|NCT02598388|BG008|Baseline|Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)|Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10904998|NCT02598388|BG009|Baseline|Part 2 (Group 2): Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
11172289|NCT02008565|OG003|Outcome|Placebo - Education Only|Participants receive placebo drug and educational pamphlet (usual care).
11172290|NCT02008565|OG000|Outcome|Loperamide - Exercise Plus Biofeedback|Participants receive loperamide drug and anal exercise with biofeedback intervention.
10904999|NCT02598388|BG010|Baseline|Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905000|NCT02598388|BG011|Baseline|Part 2 (Group 2): Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905001|NCT02598388|BG012|Baseline|Total|Total of all reporting groups
10905002|NCT02598388|FG000|Participant Flow|Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)|Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905003|NCT02598388|FG001|Participant Flow|Part 1: Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905004|NCT02598388|FG002|Participant Flow|Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)|Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905005|NCT02598388|FG003|Participant Flow|Part 1: Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905006|NCT02598388|FG004|Participant Flow|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)|Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905007|NCT02598388|FG005|Participant Flow|Part 2 (Group 1): Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10905008|NCT02598388|FG006|Participant Flow|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905009|NCT02598388|FG007|Participant Flow|Part 2 (Group 1): Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10905010|NCT02598388|FG008|Participant Flow|Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)|Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905011|NCT02598388|FG009|Participant Flow|Part 2 (Group 2): Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905012|NCT02598388|FG010|Participant Flow|Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
11172291|NCT02008565|OG001|Outcome|Placebo - Exercise Plus Biofeedback|Participants receive placebo drug and anal exercise with biofeedback intervention.
11172292|NCT02008565|EG000|Reported Event|Loperamide - Exercise Plus Biofeedback|Participants receive loperamide drug and anal exercise with biofeedback intervention.
11172293|NCT02008565|EG001|Reported Event|Placebo - Exercise Plus Biofeedback|Participants receive placebo drug and anal exercise with biofeedback intervention.
10905013|NCT02598388|FG011|Participant Flow|Part 2 (Group 2): Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905014|NCT02598388|OG000|Outcome|Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV|Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905015|NCT02598388|OG001|Outcome|Healthy (Part 1, Part 2; Group 2): Placebo|Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
10905016|NCT02598388|OG002|Outcome|HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV|Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905017|NCT02598388|OG003|Outcome|HIV-infected (Part 1, Part 2; Group 2): Placebo|HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
10905018|NCT02598388|OG000|Outcome|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)|Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905019|NCT02598388|OG001|Outcome|Part 2 (Group 1): Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10905020|NCT02598388|OG002|Outcome|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
11172294|NCT02008565|EG002|Reported Event|Loperamide - Education Only|Participants receive loperamide drug and educational pamphlet (usual care).
11172295|NCT02008565|EG003|Reported Event|Placebo - Education Only|Participants receive placebo drug and educational pamphlet (usual care).
11172296|NCT02008617|BG000|Baseline|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
10905021|NCT02598388|OG003|Outcome|Part 2 (Group 1): Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10905022|NCT02598388|OG002|Outcome|HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV|HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905023|NCT02598388|OG004|Outcome|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)|Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905024|NCT02598388|OG005|Outcome|Part 2 (Group 1): Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10905025|NCT02598388|OG006|Outcome|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905026|NCT02598388|OG007|Outcome|Part 2 (Group 1): Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10905027|NCT02598388|OG000|Outcome|Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV|Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo as prime vaccine on Day 1 followed by IM injection of single dose Ad26.ZEBOV as booster vaccine at Day 15.
11233411|NCT02427646|BG001|Baseline|Parkinson Disease Tremor Treatment|IncobotulinumtoxinA: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
11233412|NCT02427646|BG002|Baseline|Total|Total of all reporting groups
10905028|NCT02598388|OG001|Outcome|HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV|HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo as prime vaccine on Day 1 followed by IM injection of single dose Ad26.ZEBOV as booster vaccine at Day 15.
10905029|NCT02598388|OG002|Outcome|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)|Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905030|NCT02598388|OG003|Outcome|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905031|NCT02598388|EG000|Reported Event|Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)|Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905032|NCT02598388|EG001|Reported Event|Part 1: Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905033|NCT02598388|EG002|Reported Event|Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)|Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
11342293|NCT03704376|BG000|Baseline|Femoral Nerve Blockade|"Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.~30 ml of 0.2% ropivacaine~100 mcg clonidine~High-frequency linear ultrasound transducer"
10905034|NCT02598388|EG003|Reported Event|Part 1: Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905035|NCT02598388|EG004|Reported Event|Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)|Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905036|NCT02598388|EG005|Reported Event|Part 2 (Group 2): Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905037|NCT02598388|EG006|Reported Event|Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
10905038|NCT02598388|EG007|Reported Event|Part 2 (Group 2): Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
10905039|NCT02598388|EG008|Reported Event|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)|Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905040|NCT02598388|EG009|Reported Event|Part 2 (Group 1): Placebo (Healthy Participants)|Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10905041|NCT02598388|EG010|Reported Event|Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
10905042|NCT02598388|EG011|Reported Event|Part 2 (Group 1): Placebo (HIV-infected Participants)|HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
10905043|NCT02493751|BG000|Baseline|Axitinib + Avelumab With Lead-in|Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
10905044|NCT02493751|BG001|Baseline|Axitinib + Avelumab|Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
10905045|NCT02493751|BG002|Baseline|Total|Total of all reporting groups
10905046|NCT02493751|FG000|Participant Flow|Axitinib + Avelumab With Lead-in|Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
10905047|NCT02493751|FG001|Participant Flow|Axitinib + Avelumab|Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
10905048|NCT02493751|OG000|Outcome|Axitinib + Avelumab With Lead-in|Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
10905049|NCT02493751|OG001|Outcome|Axitinib + Avelumab|Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
10905050|NCT02493751|OG000|Outcome|All Participants|Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
10905051|NCT02493751|EG000|Reported Event|Axitinib + Avelumab With Lead-in|Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
10905052|NCT02493751|EG001|Reported Event|Axitinib + Avelumab|Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
10905053|NCT02285166|BG000|Baseline|Overall|Participants received standard antihyperlipidemic therapy with or without intervention of omega-3 fatty acid ethyl esters by the end of surveillance as part of a routine medical care.
10905054|NCT02285166|FG000|Participant Flow|Overall|Participants received standard antihyperlipidemic therapy with or without intervention of omega-3 fatty acid ethyl esters by the end of surveillance as part of a routine medical care.
10905055|NCT02285166|OG000|Outcome|Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g|The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
10905056|NCT02285166|OG000|Outcome|Never User of Omega-3 Fatty Acid Ethyl Esters 2 g|Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
10905057|NCT02285166|OG000|Outcome|Never User of Omega-3- Fatty Acid Ethyl Esters 2 g|Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
10905058|NCT02285166|EG000|Reported Event|Omega-3 Fatty Acid Ethyl Esters 2 g|The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care. Reported groups were combined in this section because group assignment (groups with or without intervention of omega-3 fatty acid ethyl esters) was conducted after completion of data collection (collection of Case Report Form) in this observational study and collection of data for each group during this study was not planned on the protocol of this study.
10905059|NCT02075593|BG000|Baseline|DTG/ABC/3TC - Mother|Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
10905060|NCT02075593|FG000|Participant Flow|DTG/ABC/3TC - Mother|Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
10905061|NCT02075593|OG000|Outcome|DTG/ABC/3TC - Mother|Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
10905062|NCT02075593|OG000|Outcome|DTG/ABC/3TC - Infant|This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.
10905063|NCT02075593|EG000|Reported Event|DTG/ABC/3TC - Mother|Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
10905064|NCT02075593|EG001|Reported Event|DTG/ABC/3TC - Infant|This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.
10905065|NCT00587860|BG000|Baseline|St. John's Wort|St. John's Wort, 450 mg twice a day
10905066|NCT00587860|BG001|Baseline|Placebo|Placebo, twice a day
10905067|NCT00587860|BG002|Baseline|Total|Total of all reporting groups
10905068|NCT00587860|FG000|Participant Flow|St. John's Wort|St. John's Wort, 450 mg twice a day
10905069|NCT00587860|FG001|Participant Flow|Placebo|Placebo, twice a day
10905070|NCT00587860|OG000|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
10905071|NCT00587860|OG001|Outcome|Placebo|Placebo, twice a day
10905072|NCT00587860|EG000|Reported Event|St. John's Wort|St. John's Wort, 450 mg twice a day
10905073|NCT00587860|EG001|Reported Event|Placebo|Placebo, twice a day
10915075|NCT00634049|OG003|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
10915076|NCT00634049|OG004|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
10915077|NCT00634049|OG005|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
10915078|NCT00634049|OG006|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
10915079|NCT00634049|OG007|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
10915080|NCT00634049|OG008|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
10915081|NCT00634049|OG009|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
10915082|NCT00634049|OG000|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired or not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
10915083|NCT00634049|OG003|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
10915084|NCT00634049|OG004|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
10915085|NCT00634049|OG005|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
10915086|NCT00634049|OG006|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
10915087|NCT00634049|OG000|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
10915088|NCT00634049|OG009|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
10915089|NCT00634049|OG001|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Overall there were 24 participants in the mITTAspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
10915200|NCT00634543|EG001|Reported Event|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
10905074|NCT00587964|BG000|Baseline|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
10905075|NCT00587964|FG000|Participant Flow|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
10905076|NCT00587964|OG000|Outcome|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
10905077|NCT00587964|EG000|Reported Event|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
10905078|NCT00587990|BG000|Baseline|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
10905079|NCT00587990|BG001|Baseline|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
10905080|NCT00587990|BG002|Baseline|(3) Placebo|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
10905081|NCT00587990|BG003|Baseline|Total|Total of all reporting groups
10905082|NCT00587990|FG000|Participant Flow|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
10905083|NCT00587990|FG001|Participant Flow|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
10905084|NCT00587990|FG002|Participant Flow|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
10905085|NCT00587990|OG000|Outcome|Treated Group (Low/High Doses)|Participants who received mesenchymal stem cell injections.
10905086|NCT00587990|OG001|Outcome|Placebo Group|Participants who received placebo injections.
10905087|NCT00587990|OG000|Outcome|Treated Group (Low/High Doses)|Participants who received mesenchymal stem cell injections
10905088|NCT00587990|EG000|Reported Event|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
10905089|NCT00587990|EG001|Reported Event|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
10905090|NCT00587990|EG002|Reported Event|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
10905091|NCT00588094|BG000|Baseline|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
10905092|NCT00588094|FG000|Participant Flow|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
10905093|NCT00588094|OG000|Outcome|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
10905094|NCT00588094|EG000|Reported Event|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
10905095|NCT00588159|BG000|Baseline|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
10905096|NCT00588159|BG001|Baseline|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
10905097|NCT00588159|BG002|Baseline|Total|Total of all reporting groups
10905098|NCT00588159|FG000|Participant Flow|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
10905099|NCT00588159|FG001|Participant Flow|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
10905100|NCT00588159|OG000|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
10905101|NCT00588159|OG001|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
10905102|NCT00588159|EG000|Reported Event|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
10905103|NCT00588159|EG001|Reported Event|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
10905104|NCT00588237|BG000|Baseline|All Patients|Paclitaxel, Cisplatin, Bevacizumab
10905105|NCT00588237|FG000|Participant Flow|All Patients|Paclitaxel, Cisplatin, Bevacizumab
11233413|NCT02427646|FG000|Participant Flow|Essential Tremor Treatment|IncobotulinumtoxinA: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
10905106|NCT00588237|OG000|Outcome|All Patients|Paclitaxel, Cisplatin, Bevacizumab
10905107|NCT00588237|EG000|Reported Event|All Patients|Paclitaxel, Cisplatin, Bevacizumab
10905108|NCT00588341|BG000|Baseline|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
10905109|NCT00588341|FG000|Participant Flow|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
10905110|NCT00588341|OG000|Outcome|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
10905111|NCT00588341|EG000|Reported Event|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
10905112|NCT00588354|BG000|Baseline|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
10905113|NCT00588354|BG001|Baseline|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
10905114|NCT00588354|BG002|Baseline|Total|Total of all reporting groups
10905115|NCT00588354|FG000|Participant Flow|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
10905116|NCT00588354|FG001|Participant Flow|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
10905117|NCT00588354|OG000|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
10905118|NCT00588354|OG001|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
10905119|NCT00588354|OG000|Outcome|2% Lidocaine and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
10905120|NCT00588354|EG000|Reported Event|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
10905121|NCT00588354|EG001|Reported Event|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
10905122|NCT00588380|BG000|Baseline|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
10905123|NCT00588380|FG000|Participant Flow|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
10905124|NCT00588380|OG000|Outcome|All Participants|C-peptide as a marker of insulin secretion
10905125|NCT00588380|OG000|Outcome|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
10905126|NCT00588380|EG000|Reported Event|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
10905127|NCT00588406|BG000|Baseline|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
10905128|NCT00588406|BG001|Baseline|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
10905129|NCT00588406|BG002|Baseline|Total|Total of all reporting groups
10905130|NCT00588406|FG000|Participant Flow|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
10905131|NCT00588406|FG001|Participant Flow|Placob|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
10905132|NCT00588406|OG000|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
10905133|NCT00588406|OG001|Outcome|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
10905134|NCT00588406|EG000|Reported Event|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
10905135|NCT00588406|EG001|Reported Event|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
10905136|NCT00588445|BG000|Baseline|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
10905137|NCT00588445|FG000|Participant Flow|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
10905138|NCT00588445|OG000|Outcome|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
10905139|NCT00588445|OG000|Outcome|EGFR Mutation Positive|Tumor specimens analyzed for EGFR mutation
10905140|NCT00588445|OG001|Outcome|EGFR Mutation Negative|Tumor specimens analyzed for EGFR mutation
10905141|NCT00588445|EG000|Reported Event|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
10905142|NCT00588536|BG000|Baseline|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
10905143|NCT00588536|FG000|Participant Flow|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
10905144|NCT00588536|OG000|Outcome|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
10905145|NCT00588536|EG000|Reported Event|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
10905146|NCT00588640|BG000|Baseline|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
10905147|NCT00588640|FG000|Participant Flow|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
10905148|NCT00588640|OG000|Outcome|Phase I, Cohort l|"oral d-methadone 40 mg~d-Methadone: 8 subjects to receive 40 mg d-Methadone twice a day"
10905149|NCT00588640|EG000|Reported Event|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
10905150|NCT00588666|BG000|Baseline|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
10905151|NCT00588666|FG000|Participant Flow|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
10905152|NCT00588666|OG000|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
10905153|NCT00588666|EG000|Reported Event|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
10905154|NCT00588692|BG000|Baseline|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
10905155|NCT00588692|BG001|Baseline|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
10905156|NCT00588692|BG002|Baseline|Total|Total of all reporting groups
10905157|NCT00588692|FG000|Participant Flow|SphygmoCor Unblinded|"The use of the sphygmocor values will determine medication adjustments to optimize heart failure (HF) treatment.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
10905158|NCT00588692|FG001|Participant Flow|SphygmoCor Blinded|"Sphygmocor values will be blinded to the investigator.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
10905159|NCT00588692|OG000|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
10905160|NCT00588692|OG001|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
10905161|NCT00588692|OG000|Outcome|Treatment|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
10905162|NCT00588692|OG001|Outcome|Control|Sphygmocor values will be blinded to the investigator.
10905163|NCT00588692|EG000|Reported Event|Treatment|"The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
10905164|NCT00588692|EG001|Reported Event|Control|"Sphygmocor values will be blinded to the investigator.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
10905165|NCT00588731|BG000|Baseline|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
10905166|NCT00588731|BG001|Baseline|Placebo|Placebo: Placebo
10905167|NCT00588731|BG002|Baseline|Total|Total of all reporting groups
10905168|NCT00588731|FG000|Participant Flow|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
10905169|NCT00588731|FG001|Participant Flow|Placebo|Placebo: Placebo
10905170|NCT00588731|OG000|Outcome|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
10905171|NCT00588731|OG001|Outcome|Placebo|Placebo: Placebo
10905172|NCT00588731|EG000|Reported Event|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
10905173|NCT00588731|EG001|Reported Event|Placebo|Placebo: Placebo
10905174|NCT00588809|BG000|Baseline|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
10905175|NCT00588809|FG000|Participant Flow|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
10905176|NCT00588809|OG000|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
10905177|NCT00588809|EG000|Reported Event|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
10905178|NCT00588822|BG000|Baseline|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
10905179|NCT00588822|FG000|Participant Flow|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
11172297|NCT02008617|BG001|Baseline|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
10905180|NCT00588822|OG000|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
10905181|NCT00588822|EG000|Reported Event|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
10905182|NCT00588848|BG000|Baseline|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
10905183|NCT00588848|BG001|Baseline|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
10905184|NCT00588848|BG002|Baseline|Total|Total of all reporting groups
10905185|NCT00588848|FG000|Participant Flow|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
10905186|NCT00588848|FG001|Participant Flow|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
10905187|NCT00588848|OG000|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
10905188|NCT00588848|OG001|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
10905189|NCT00588848|OG000|Outcome|Autoadjusting CPAP (VPAP Auto)|"The intervention will be the use of an Autoadjusting CPAP unit that will be applied to the subject during the 8 hours overnight the first night after surgery (study night). During this time, they will undergo a full night attended polysomnogram in their hospital room.~Autoadjusting CPAP (VPAP Auto): An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery)."
10915201|NCT00634569|BG000|Baseline|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
11172298|NCT02008617|BG002|Baseline|Total|Total of all reporting groups
11172299|NCT02008617|FG000|Participant Flow|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
11172300|NCT02008617|FG001|Participant Flow|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
11172301|NCT02008617|OG000|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
10905190|NCT00588848|OG001|Outcome|CPAP Arm (Usual Care)|"The intervention will be the use of the subject's own CPAP machine and this will be applied to the subject during the 8 hours overnight the first after surgery (study night). During the study night, they will undergo full polysomnography in their hospital room.~CPAP: Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)"
10905191|NCT00588848|EG000|Reported Event|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
10905192|NCT00588848|EG001|Reported Event|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
10905193|NCT00588900|BG000|Baseline|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
10905194|NCT00588900|FG000|Participant Flow|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
10905195|NCT00588900|OG000|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
10905196|NCT00588900|EG000|Reported Event|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
10905197|NCT00588952|BG000|Baseline|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
10905198|NCT00588952|BG001|Baseline|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
10905199|NCT00588952|BG002|Baseline|Total|Total of all reporting groups
10905200|NCT00588952|FG000|Participant Flow|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
10905201|NCT00588952|FG001|Participant Flow|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
10905202|NCT00588952|OG000|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
10905203|NCT00588952|OG001|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
10905204|NCT00588952|EG000|Reported Event|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
11172302|NCT02008617|OG001|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
10905205|NCT00588952|EG001|Reported Event|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
10905206|NCT00588965|BG000|Baseline|All Subjects|Subjects will take propranolol LA 80 mg or placebo daily for one week then propranolol LA 160 mg for one week or 2 placebo pills, followed by the exercise test. The participants will be randomized to one of 2 sequences: placebo first or propranolol first.
10905207|NCT00588965|FG000|Participant Flow|All Participants|All participants were randomized to one of 2 sequences, in which they received either propranolol first, then placebo, or placebo first, then propranolol.
10905208|NCT00588965|OG000|Outcome|Placebo|
10905209|NCT00588965|OG001|Outcome|Propranolol|
10905210|NCT00588965|EG000|Reported Event|Placebo|Subjects are assigned to placebo.
10905211|NCT00588965|EG001|Reported Event|Propranolol|Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test.
10905212|NCT00589056|BG000|Baseline|Single Arm|"Nelfinavir~cisplatin~etoposide~nelfinavir mesylate~protein expression analysis~immunohistochemistry staining method~laboratory biomarker analysis~biopsy~radiation therapy"
10915202|NCT00634569|BG001|Baseline|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
10915203|NCT00634569|BG002|Baseline|Total|Total of all reporting groups
11172303|NCT02008617|EG000|Reported Event|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
10905213|NCT00589056|FG000|Participant Flow|Single Arm|"Nelfinavir~cisplatin~etoposide~nelfinavir mesylate~protein expression analysis~immunohistochemistry staining method~laboratory biomarker analysis~biopsy~radiation therapy"
10905214|NCT00589056|OG000|Outcome|Single Arm|"Nelfinavir~cisplatin~etoposide~nelfinavir mesylate~protein expression analysis~immunohistochemistry staining method~laboratory biomarker analysis~biopsy~radiation therapy"
10905215|NCT00589056|EG000|Reported Event|Single Arm|"Nelfinavir~cisplatin~etoposide~nelfinavir mesylate~protein expression analysis~immunohistochemistry staining method~laboratory biomarker analysis~biopsy~radiation therapy"
10905216|NCT00589108|BG000|Baseline|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
10905217|NCT00589108|BG001|Baseline|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
10905218|NCT00589108|BG002|Baseline|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
10905219|NCT00589108|BG003|Baseline|Total|Total of all reporting groups
10905220|NCT00589108|FG000|Participant Flow|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
10905221|NCT00589108|FG001|Participant Flow|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
10905222|NCT00589108|FG002|Participant Flow|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
10905223|NCT00589108|OG000|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
10905224|NCT00589108|OG001|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
10905225|NCT00589108|OG002|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
10905226|NCT00589108|EG000|Reported Event|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
10905227|NCT00589108|EG001|Reported Event|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
10905228|NCT00589108|EG002|Reported Event|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
10905229|NCT00589121|BG000|Baseline|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
10905230|NCT00589121|BG001|Baseline|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
11172304|NCT02008617|EG001|Reported Event|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
10905231|NCT00589121|BG002|Baseline|Total|Total of all reporting groups
10905232|NCT00589121|FG000|Participant Flow|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
10905233|NCT00589121|FG001|Participant Flow|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
10905234|NCT00589121|OG000|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
10905235|NCT00589121|OG000|Outcome|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
10905236|NCT00589121|OG001|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
10905237|NCT00589121|OG000|Outcome|No Late Radiation Morbitity|
10905238|NCT00589121|OG001|Outcome|Has Late Radiation Toxicity|
10905239|NCT00589121|EG000|Reported Event|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
10905240|NCT00589121|EG001|Reported Event|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
10905241|NCT00589277|BG000|Baseline|Standard Care Counseling|Standard care counseling + standard care print information
10905242|NCT00589277|BG001|Baseline|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
10905243|NCT00589277|BG002|Baseline|Total|Total of all reporting groups
10905244|NCT00589277|FG000|Participant Flow|Standard Care Counseling + Standard Care Print Information|Standard care counseling + standard care print information
10905245|NCT00589277|FG001|Participant Flow|Gain-Framed Counseling|Callers were randomly assigned to receive gain-framed counseling messages and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
10905246|NCT00589277|OG000|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
10905247|NCT00589277|OG001|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
10905248|NCT00589277|EG000|Reported Event|Standard Care Counseling|Standard care counseling + standard care print information
10915204|NCT00634569|FG000|Participant Flow|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
11172305|NCT02008682|BG000|Baseline|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
11172306|NCT02008682|BG001|Baseline|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
11172307|NCT02008682|BG002|Baseline|Total|Total of all reporting groups
11172308|NCT02008682|FG000|Participant Flow|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
11172309|NCT02008682|FG001|Participant Flow|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
11172310|NCT02008682|OG000|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
10905249|NCT00589277|EG001|Reported Event|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
10905250|NCT00589290|BG000|Baseline|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
10905251|NCT00589290|FG000|Participant Flow|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
10905252|NCT00589290|OG000|Outcome|Thymoma Patients|Well differentiated neoplasm
10905253|NCT00589290|OG001|Outcome|Thymic Patients|Poorly differentiated neoplasm
10905254|NCT00589290|OG000|Outcome|Belinostat|1000 mg/m^2 day, 30 minute intravenous infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
10905255|NCT00589290|EG000|Reported Event|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
10905256|NCT00589303|BG000|Baseline|Drug Therapy|FDA approved rate and rhythm control drugs
10905257|NCT00589303|BG001|Baseline|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
11172311|NCT02008682|OG001|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
11172312|NCT02008682|EG000|Reported Event|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
10905258|NCT00589303|BG002|Baseline|Total|Total of all reporting groups
10905259|NCT00589303|FG000|Participant Flow|Drug Therapy|FDA approved rate and rhythm control drugs
10905260|NCT00589303|FG001|Participant Flow|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
10905261|NCT00589303|OG000|Outcome|Drug Therapy|FDA approved rate and rhythm control drugs
10905262|NCT00589303|OG001|Outcome|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
10905263|NCT00589303|EG000|Reported Event|Drug Therapy|FDA approved rate and rhythm control drugs
10905264|NCT00589303|EG001|Reported Event|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
10905265|NCT00589329|BG000|Baseline|Group A|Antibiotic group
10905266|NCT00589329|BG001|Baseline|Group B|Non antibiotic group
10905267|NCT00589329|BG002|Baseline|Total|Total of all reporting groups
10905268|NCT00589329|FG000|Participant Flow|Group A|"Group A will be assigned to receive antibiotics:~Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days.~erythromycin and metronidazole (antibiotics): Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days"
10905269|NCT00589329|FG001|Participant Flow|Group B|"Group B will not receive antibiotics for pregnancy prolongation, but will receive a matching masked placebo (IV saline and pill) regimen.~placebo: IV and pill placebo"
10905270|NCT00589329|OG000|Outcome|Group A|"Group A will be assigned to receive antibiotics:~Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days.~erythromycin and metronidazole (antibiotics): Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days"
10915205|NCT00634569|FG001|Participant Flow|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
11172313|NCT02008682|EG001|Reported Event|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
11172314|NCT02008773|BG000|Baseline|HSV1+ Placebo|HSV1 positive subjects assigned to the HSV1+ placebo arm
11172315|NCT02008773|BG001|Baseline|HSV1+ Valacyclovir|HSV1 positive subjects assigned to the Valacyclovir study treatment arm
11172316|NCT02008773|BG002|Baseline|HSV1- Placebo|HSV1 negative subjects assigned to the placebo arm
11172317|NCT02008773|BG003|Baseline|HSV1- Valacyclovir|HSV1 negative subjects assigned to the Valacyclovir study treatment arm
11172318|NCT02008773|BG004|Baseline|Total|Total of all reporting groups
10905271|NCT00589329|OG001|Outcome|Group B|"Group B will not receive antibiotics for pregnancy prolongation, but will receive a matching masked placebo (IV saline and pill) regimen.~placebo: IV and pill placebo"
10905272|NCT00589329|OG000|Outcome|Group A|"roup A will be assigned to receive antibiotics:~Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days.~erythromycin and metronidazole (antibiotics): Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days"
10905273|NCT00589329|EG000|Reported Event|Group A|"roup A will be assigned to receive antibiotics:~Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days.~erythromycin and metronidazole (antibiotics): Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days"
10905274|NCT00589329|EG001|Reported Event|Group B|"Group B will not receive antibiotics for pregnancy prolongation, but will receive a matching masked placebo (IV saline and pill) regimen.~placebo: IV and pill placebo"
10905275|NCT00589472|BG000|Baseline|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
10905276|NCT00589472|FG000|Participant Flow|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
10905277|NCT00589472|OG000|Outcome|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
10905278|NCT00589472|EG000|Reported Event|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
10905279|NCT00589563|BG000|Baseline|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
10905280|NCT00589563|FG000|Participant Flow|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
10905281|NCT00589563|OG000|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
10905282|NCT00589563|EG000|Reported Event|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
10905283|NCT00589602|BG000|Baseline|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
11172319|NCT02008773|FG000|Participant Flow|HSV1+ Placebo|HSV1 positive subjects assigned to the HSV1+ placebo arm
11172320|NCT02008773|FG001|Participant Flow|HSV1+ Valacyclovir|HSV1 positive subjects assigned to the Valacyclovir study treatment arm
10915206|NCT00634569|OG000|Outcome|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
10915207|NCT00634569|OG001|Outcome|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
11172321|NCT02008773|FG002|Participant Flow|HSV1- Placebo|HSV1 negative subjects assigned to the placebo arm
11172322|NCT02008773|FG003|Participant Flow|HSV1- Valacyclovir|HSV1 negative subjects assigned to the Valacyclovir study treatment arm
11172323|NCT02008773|OG000|Outcome|HSV1+ Valacyclovir|HSV1 positive subjects assigned to the Valacyclovir study treatment arm
10905284|NCT00589602|FG000|Participant Flow|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
10905285|NCT00589602|OG000|Outcome|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
10905286|NCT00589602|OG000|Outcome|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of matched unrelated donor allogeneic bone marrow transplant (MUD allo BMT) and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; allogeneic hematopoietic stem cell transplantation;~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
10905287|NCT00589602|OG000|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.~cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day -5 and Day -4~tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
10905288|NCT00589602|EG000|Reported Event|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
10905289|NCT00589628|BG000|Baseline|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
10905290|NCT00589628|BG001|Baseline|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
10905291|NCT00589628|BG002|Baseline|Total|Total of all reporting groups
10905292|NCT00589628|FG000|Participant Flow|Infliximab 5 mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
10905293|NCT00589628|FG001|Participant Flow|Infliximab 10 mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
10905294|NCT00589628|OG000|Outcome|Infliximab 5mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
10905295|NCT00589628|OG001|Outcome|Infliximab 10mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
10905296|NCT00589628|EG000|Reported Event|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
10905297|NCT00589628|EG001|Reported Event|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
10905298|NCT00589667|BG000|Baseline|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
10905299|NCT00589667|FG000|Participant Flow|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
10905300|NCT00589667|OG000|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
10905301|NCT00589667|EG000|Reported Event|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
10905302|NCT00589693|BG000|Baseline|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
10905303|NCT00589693|BG001|Baseline|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
10905304|NCT00589693|BG002|Baseline|Total|Total of all reporting groups
10905305|NCT00589693|FG000|Participant Flow|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
10905306|NCT00589693|FG001|Participant Flow|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
10905307|NCT00589693|OG000|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
10905308|NCT00589693|OG001|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
10905309|NCT00589693|EG000|Reported Event|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
10905310|NCT00589693|EG001|Reported Event|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
10905311|NCT00589784|BG000|Baseline|Aggressive Memingioma|Patients with Aggressive Memingioma
10905312|NCT00589784|BG001|Baseline|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
10905313|NCT00589784|BG002|Baseline|Total|Total of all reporting groups
10905314|NCT00589784|FG000|Participant Flow|Aggressive Memingioma|Patients with Aggressive Memingioma
10905315|NCT00589784|FG001|Participant Flow|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
10905316|NCT00589784|OG000|Outcome|Aggressive Memingioma|Patients with Aggressive Memingioma
10905317|NCT00589784|OG001|Outcome|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
10905318|NCT00589784|EG000|Reported Event|All Patients|All patients treated with Sunitinib (SU011248)
10905319|NCT00589797|BG000|Baseline|Investigational|Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
10905320|NCT00589797|BG001|Baseline|Control|Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
10905321|NCT00589797|BG002|Baseline|Total|Total of all reporting groups
10905322|NCT00589797|FG000|Participant Flow|Investigational|Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
10905323|NCT00589797|FG001|Participant Flow|Control|Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
10905324|NCT00589797|OG000|Outcome|Investigational|Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
10905325|NCT00589797|OG001|Outcome|Control|Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
10905326|NCT00589797|EG000|Reported Event|Investigational|Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
10905327|NCT00589797|EG001|Reported Event|Control|Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
10905328|NCT00589836|BG000|Baseline|Cardiac Pathologies|Patients with cardiac pathologies of aortic root disorder, severe aortic stenosis, severe aortic insufficiency, aortic valve replacement, ischemic heart disease and cardiomyopathies had tissue DTI and MRI performed
10905329|NCT00589836|FG000|Participant Flow|Cardiac Pathologies|Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
11172324|NCT02008773|OG001|Outcome|HSV1+ Placebo|HSV1 positive subjects assigned to the HSV1+ placebo arm
11172325|NCT02008773|OG002|Outcome|HSV1- Valacyclovir|HSV1 negative subjects assigned to the Valacyclovir study treatment arm
10905330|NCT00589836|OG000|Outcome|Cardiac Pathologies|Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
10905331|NCT00589836|EG000|Reported Event|Cardiac Pathologies|Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
10905332|NCT00589849|BG000|Baseline|T Wave Altenans Stress Test|
11172326|NCT02008773|OG003|Outcome|HSV1- Placebo|HSV1 negative subjects assigned to the placebo arm
10905333|NCT00589849|FG000|Participant Flow|T Wave Altenans Stress Test|
10905334|NCT00589849|OG000|Outcome|T Wave Altenans Stress Test|
10905335|NCT00589849|EG000|Reported Event|T Wave Altenans Stress Test|
10905336|NCT00589888|BG000|Baseline|All Study Participants|"All participants received all 5 arms in random order:~0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours~Intralipid 20% @ 20cc/hr for 8 hours~Intralipid 20% @ 40cc/Hr for 8 hours~32-gram Oral Fat Load every 2 hours for 8 hours.~64-gram Oral Fat Load every 2 hours for 8 hours."
10905337|NCT00589888|FG000|Participant Flow|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
10905338|NCT00589888|FG001|Participant Flow|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
10905339|NCT00589888|FG002|Participant Flow|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
10905340|NCT00589888|FG003|Participant Flow|32-gram Oral Fat Load|"32-gram oral fat load~32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
10905341|NCT00589888|FG004|Participant Flow|64-gram Oral Fat Load|"64-gram oral fat load~64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
10905342|NCT00589888|OG000|Outcome|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
10905343|NCT00589888|OG000|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
10905344|NCT00589888|OG000|Outcome|Intralipid @ 40cc/Hour for 8 Hours|Intralipid continuous IV infusion at 40cc/hour for 8 hours
10905345|NCT00589888|OG000|Outcome|Oral 32-gram Fat Load|For the low (32 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
10905346|NCT00589888|OG000|Outcome|Oral 64-gram Fat Load|For the high (64 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
10905347|NCT00589888|OG000|Outcome|Intralipid 20%@ 20cc/Hour|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20% @ 20cc/hour: In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting"
10915208|NCT00634569|OG000|Outcome|All Subjects|Intent-to-treat population
10915209|NCT00634569|EG000|Reported Event|All Subjects|Intent-to-treat population
10915210|NCT00634621|BG000|Baseline|Hexvix|Use of the Hexvix drug.
10915211|NCT00634621|FG000|Participant Flow|Hexvix 2 mg/mL Infusion|Administrtation of 2 mg/mL Hexvix.
11172327|NCT02008773|EG000|Reported Event|Valacyclovir|"3000mg daily oral 16 weeks~Valacyclovir HCI 500 mg tablets: Valacyclovir HCI 500 mg capsules 6/day oral for 16 weeks"
11172328|NCT02008773|EG001|Reported Event|Placebo|"placebo 6 capsules daily oral 16 weeks~placebo: placebo capsules 6/day oral for 16 weeks"
10905348|NCT00589888|OG001|Outcome|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%@ 40cc/hour: In this arm subjects received Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours. In this arm subjects will receive Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting."
10905349|NCT00589888|OG002|Outcome|Normal Saline Infusion @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~Normal Saline: In this arm subjects received 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours."
10905350|NCT00589888|OG003|Outcome|32-gram Oral Fat Load|"32-gram oral fat load once~32-gram oral fat load: In this arm subjects received oral liquid fat load prepared by the General Clinical Research Center (GCRC) at baseline and every 2 hours for 6 hours. Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h."
10905351|NCT00589888|OG004|Outcome|64-gram Oral Fat Load|"64-gram oral fat load once~64-gram oral fat load: In this arm subjects received 60-gram oral fat load intake at baseline and every 2 hours for 6 hours prepared by the General Clinical Research Center (GCRC). Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h."
10905352|NCT00589888|EG000|Reported Event|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
10905353|NCT00589888|EG001|Reported Event|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
10905354|NCT00589888|EG002|Reported Event|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
10905355|NCT00589888|EG003|Reported Event|32-gram Oral Fat Load|"32-gram oral fat load~32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
10905356|NCT00589888|EG004|Reported Event|64-gram Oral Fat Load|"64-gram oral fat load~64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
10905357|NCT00589914|BG000|Baseline|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
10905358|NCT00589914|BG001|Baseline|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
10905359|NCT00589914|BG002|Baseline|Total|Total of all reporting groups
10905360|NCT00589914|FG000|Participant Flow|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
10905361|NCT00589914|FG001|Participant Flow|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
10905362|NCT00589914|OG000|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
10905363|NCT00589914|OG001|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
10905364|NCT00589914|EG000|Reported Event|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
10905365|NCT00589914|EG001|Reported Event|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
10905366|NCT00589979|BG000|Baseline|Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
10905367|NCT00589979|BG001|Baseline|Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
10905368|NCT00589979|BG002|Baseline|Total|Total of all reporting groups
10905369|NCT00589979|FG000|Participant Flow|Run-in Period: Lidoderm|Run-in Period with patients applying Lidoderm (lidocaine 5% patch) 10cm x 14cm each on the front and back of the index knee every 24 hours for up to 28 days (4 weeks).
10905370|NCT00589979|FG001|Participant Flow|Treatment Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for up to 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
10905371|NCT00589979|FG002|Participant Flow|Treatment Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for up to 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
10905372|NCT00589979|OG000|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
10905373|NCT00589979|OG001|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
10905374|NCT00589979|OG000|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (Lidocaine 5% Patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
10905375|NCT00589979|OG000|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
10905376|NCT00589979|OG001|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving Placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
10905377|NCT00589979|OG001|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
10905378|NCT00589979|OG000|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
10905379|NCT00589979|EG000|Reported Event|Run-In Period With Lidoderm (Lidocaine 5% Patch)|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the active treatment Run-in Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated)."
10905380|NCT00589979|EG001|Reported Event|Double-Blind Treatment Period With Lidoderm|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the Double-blind Treatment Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).~*NOTE: two subjects randomized to the treatment sequence Placebo - Lidoderm - Lidoderm (PLL) discontinued from the study during treatment with Placebo (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Lidoderm) is equal to 91."
10905381|NCT00589979|EG002|Reported Event|Double-Blind Active Treatment Period With Placebo|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Placebo during the Double-blind Treatment Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).~**NOTE: two subjects randomized to the treatment sequence Lidoderm - Placebo - Placebo (PLL) discontinued from the study during treatment with Lidoderm (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Placebo) is equal to 91."
10905382|NCT00590005|BG000|Baseline|Children With Asthma|The cohort consists of children with physician-diagnosed asthma across a wide range of severity (mild, moderate, severe)
10905383|NCT00590005|FG000|Participant Flow|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
10905384|NCT00590005|FG001|Participant Flow|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
10905385|NCT00590005|OG000|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
10905386|NCT00590005|OG001|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
10905387|NCT00590005|EG000|Reported Event|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
10905388|NCT00590005|EG001|Reported Event|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
10905389|NCT00590018|BG000|Baseline|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
10905390|NCT00590018|BG001|Baseline|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
10905391|NCT00590018|BG002|Baseline|Total|Total of all reporting groups
10905392|NCT00590018|FG000|Participant Flow|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
10905393|NCT00590018|FG001|Participant Flow|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
10905394|NCT00590018|OG000|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
10905395|NCT00590018|OG001|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
10905396|NCT00590018|EG000|Reported Event|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
10905397|NCT00590018|EG001|Reported Event|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
10905398|NCT00590031|BG000|Baseline|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
10915212|NCT00634621|OG000|Outcome|White-light and Blue-Light Cystoscopy Simultaneously|Hexvix administered using both White-light and Blue-Light Cystoscopy.
10915213|NCT00634621|OG001|Outcome|White-light Cystoscopy Only|Hexvix administered using only White-light Cystoscopy.
10905399|NCT00590031|FG000|Participant Flow|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
10905400|NCT00590031|OG000|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
10905401|NCT00590031|EG000|Reported Event|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
10905402|NCT00590044|BG000|Baseline|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
10905403|NCT00590044|BG001|Baseline|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
10905404|NCT00590044|BG002|Baseline|Total|Total of all reporting groups
10905405|NCT00590044|FG000|Participant Flow|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
10905406|NCT00590044|FG001|Participant Flow|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
10905407|NCT00590044|OG000|Outcome|Insulin Glargine+Glulisine|"Daily insulin glargine + glulisine before meals~insulin glargine+ glulisine: Daily insulin glargine + glulisine before meals"
10905408|NCT00590044|OG001|Outcome|Split-mixed NPH + Regular Insulin|"Split-mixed NPH + Regular insulin twice daily~NPH + Regular insulin: Split-mixed NPH + Regular insulin twice daily"
10905409|NCT00590044|OG000|Outcome|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
10905410|NCT00590044|OG001|Outcome|NPH + Regular|Split-mixed Isophane (NPH) + Regular insulin twice daily
10905411|NCT00590044|OG001|Outcome|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
10905412|NCT00590044|EG000|Reported Event|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
10905413|NCT00590044|EG001|Reported Event|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
10905414|NCT00590161|BG000|Baseline|Pentoxifylline (PTX) 400 mg PO (by Mouth) TID|26 subjects received PTX at dose above for one year
10905415|NCT00590161|BG001|Baseline|Placebo TID|29 subjects received placebo as above for one year
10905416|NCT00590161|BG002|Baseline|Total|Total of all reporting groups
10905417|NCT00590161|FG000|Participant Flow|Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID)|26 subjects received PTX at dose above for one year
10905418|NCT00590161|FG001|Participant Flow|Placebo TID|29 subjects received placebo as above for one year
10905419|NCT00590161|OG000|Outcome|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
11172329|NCT02008877|BG000|Baseline|Ganetespib / Sirolimus|"28-day cycles of ganetespib + sirolimus~ganetespib: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 2mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
11172330|NCT02008877|FG000|Participant Flow|Phase 1 Dose 1|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 150 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
10905420|NCT00590161|OG001|Outcome|Placebo Tid|29 subjects received placebo as above for one year
10905421|NCT00590161|EG000|Reported Event|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
10905422|NCT00590161|EG001|Reported Event|Placebo Tid|29 subjects received placebo as above for one year
10905423|NCT00590226|BG000|Baseline|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
10905424|NCT00590226|BG001|Baseline|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
10905425|NCT00590226|BG002|Baseline|Total|Total of all reporting groups
10905426|NCT00590226|FG000|Participant Flow|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
10905427|NCT00590226|FG001|Participant Flow|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
10905428|NCT00590226|OG000|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
10905429|NCT00590226|OG001|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
10905430|NCT00590226|EG000|Reported Event|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
10905431|NCT00590226|EG001|Reported Event|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
10905432|NCT00590317|BG000|Baseline|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
10905433|NCT00590317|BG001|Baseline|Ondansetron|Patients receiving Ondansetron 4 mg IV
10905434|NCT00590317|BG002|Baseline|Total|Total of all reporting groups
10905435|NCT00590317|FG000|Participant Flow|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
10905436|NCT00590317|FG001|Participant Flow|Ondansetron|Patients receiving Ondansetron 4mg IV
10905437|NCT00590317|OG000|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
10905438|NCT00590317|OG001|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
10905439|NCT00590317|OG000|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
10905440|NCT00590317|EG000|Reported Event|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
10905441|NCT00590317|EG001|Reported Event|Ondansetron|Patients receiving Ondansetron 4mg IV
10905442|NCT00590369|BG000|Baseline|KCI VAC|KCI VAC type negative pressure wound therapy device
10905443|NCT00590369|BG001|Baseline|Versatile One|Versatile One (EZCare)negative wound therapy device
10905444|NCT00590369|BG002|Baseline|Total|Total of all reporting groups
10905445|NCT00590369|FG000|Participant Flow|KCI VAC|KCI VAC type negative pressure wound therapy device
10905446|NCT00590369|FG001|Participant Flow|Versatile One|Versatile One (EZCare)negative wound therapy device
10905447|NCT00590369|OG000|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
10905448|NCT00590369|OG001|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
10905449|NCT00590369|EG000|Reported Event|KCI VAC|KCI VAC type negative pressure wound therapy device
10905450|NCT00590369|EG001|Reported Event|Versatile One|Versatile One (EZCare)negative wound therapy device
10905451|NCT00590395|BG000|Baseline|Patients With Suspected Acute Cholecystitis|"19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical.~18FDG (an FDA-approved radiopharmaceutical): Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration"
10905452|NCT00590395|FG000|Participant Flow|Patients With Suspected Acute Cholecystitis|"19 patients with suspected acute cholecystitis and a positive hepatobiliary iminodiacetic acid (HIDA) will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG (fluorodeoxyglucose) Positron Emission Tomography - Computed Tomography (PET/CT) exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical.~18FDG (an FDA-approved radiopharmaceutical): Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration"
10905453|NCT00590395|OG000|Outcome|Suspected Acute Cholecystitis|"19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical.~18FDG (an FDA-approved radiopharmaceutical): Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration"
10905454|NCT00590395|EG000|Reported Event|Suspected Acute Cholecystitis|"19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical.~18FDG (an FDA-approved radiopharmaceutical): Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration"
10905455|NCT00590460|BG000|Baseline|Group1|only one group
10905456|NCT00590460|FG000|Participant Flow|Allo Stem Cell Transplant|Allogeneic Stem Cell Transplant
10905457|NCT00590460|OG000|Outcome|Allogeneic Stem Cell Transplant|Single Group: Allogeneic Stem Cell Transplant
10905458|NCT00590460|OG000|Outcome|Allogeneic Stem Cell Transplant|Single Group - Allogeneic Stem Cell Transplant
10905459|NCT00590460|OG000|Outcome|Allo Stem Cell Transplant|Allogeneic Stem Cell Transplant
10905460|NCT00590460|OG000|Outcome|Allogeneic Stem Cell Transplant|Single group: Allogeneic Stem Cell Transplant
10905461|NCT00590460|OG000|Outcome|Allogeneic Stem Cell Transplant|only one group
10905462|NCT00590460|EG000|Reported Event|Group1|only one group
10905463|NCT00590564|BG000|Baseline|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
10905464|NCT00590564|FG000|Participant Flow|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
10905465|NCT00590564|OG000|Outcome|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
10905466|NCT00590564|EG000|Reported Event|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
10905467|NCT00590577|BG000|Baseline|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
10905468|NCT00590577|BG001|Baseline|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
10905469|NCT00590577|BG002|Baseline|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
10905470|NCT00590577|BG003|Baseline|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
10905471|NCT00590577|BG004|Baseline|Total|Total of all reporting groups
10905472|NCT00590577|FG000|Participant Flow|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
10915214|NCT00634621|OG002|Outcome|Blue-light Cystoscopy Only|Hexvix administered using only Blue-light Cystoscopy.
10905473|NCT00590577|FG001|Participant Flow|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
10905474|NCT00590577|FG002|Participant Flow|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
10905475|NCT00590577|FG003|Participant Flow|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
10905476|NCT00590577|OG000|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
10905477|NCT00590577|OG001|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
10905478|NCT00590577|OG002|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
10905479|NCT00590577|OG003|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
10905480|NCT00590577|EG000|Reported Event|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
10905481|NCT00590577|EG001|Reported Event|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
10905482|NCT00590577|EG002|Reported Event|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
10905483|NCT00590577|EG003|Reported Event|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
10905484|NCT00590590|BG000|Baseline|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
10905485|NCT00590590|BG001|Baseline|Lidocaine|Lidocaine administered twice weekly for 4 months
10905486|NCT00590590|BG002|Baseline|Placebo|Placebo administered twice weekly for 4 months
10905487|NCT00590590|BG003|Baseline|Total|Total of all reporting groups
10905488|NCT00590590|FG000|Participant Flow|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
10905489|NCT00590590|FG001|Participant Flow|Lidocaine|Lidocaine administered twice weekly for 4 months
10905490|NCT00590590|FG002|Participant Flow|Placebo|Placebo administered twice weekly for 4 months
10905491|NCT00590590|OG000|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
10905492|NCT00590590|OG001|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
10905493|NCT00590590|OG002|Outcome|Placebo|Placebo administered twice weekly for 4 months
10905494|NCT00590590|EG000|Reported Event|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
10905495|NCT00590590|EG001|Reported Event|Lidocaine|Lidocaine administered twice weekly for 4 months
10905496|NCT00590590|EG002|Reported Event|Placebo|Placebo administered twice weekly for 4 months
10905497|NCT00590681|BG000|Baseline|Treatment|"This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days).~Bevacizumab and Temozolomide: This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days)."
10905498|NCT00590681|FG000|Participant Flow|Treatment|"This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days).~Bevacizumab and Temozolomide: This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days)."
10915090|NCT00634049|OG002|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
10915215|NCT00634621|OG003|Outcome|Multiple Normalized Biopsy|Only Multiple Normalized Biopsy.
10915216|NCT00634621|OG000|Outcome|Confirmed Bladder Cancer by Standard of Truth|Using the Hexvix drug with a cystoscopy technique of White-light cystoscopy and Blue-light cystoscopy.
10905499|NCT00590681|OG000|Outcome|Treatment|"This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days).~Bevacizumab and Temozolomide: This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days)."
10905500|NCT00590681|EG000|Reported Event|Treatment|"This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days).~Bevacizumab and Temozolomide: This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days)."
10905501|NCT00590707|BG000|Baseline|Deeper Sedation|"Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the deeper sedation arm.~Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0."
10905502|NCT00590707|BG001|Baseline|Moderate Sedation|"Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the moderate sedation arm.~Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5."
10905503|NCT00590707|BG002|Baseline|Total|Total of all reporting groups
10905504|NCT00590707|FG000|Participant Flow|Deeper Sedation|"Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the deeper sedation arm.~Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0."
10905505|NCT00590707|FG001|Participant Flow|Moderate Sedation|"Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the moderate sedation arm.~Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5."
10905506|NCT00590707|OG000|Outcome|Deeper Sedation|"Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the deeper sedation arm.~Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0."
10905507|NCT00590707|OG001|Outcome|Moderate Sedation|"Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the moderate sedation arm.~Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5."
10905508|NCT00590707|EG000|Reported Event|Deeper Sedation|"Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the deeper sedation arm.~Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0."
10905509|NCT00590707|EG001|Reported Event|Moderate Sedation|"Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the moderate sedation arm.~Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5."
10905510|NCT00590720|BG000|Baseline|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
10905511|NCT00590720|BG001|Baseline|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
10905512|NCT00590720|BG002|Baseline|Total|Total of all reporting groups
10905513|NCT00590720|FG000|Participant Flow|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
10905514|NCT00590720|FG001|Participant Flow|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
10905515|NCT00590720|OG000|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
10905516|NCT00590720|OG001|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
10905517|NCT00590720|EG000|Reported Event|PLACEBO|
10905518|NCT00590720|EG001|Reported Event|MEDI528 50 mg|
10905519|NCT00590759|BG000|Baseline|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
10905520|NCT00590759|FG000|Participant Flow|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
10905521|NCT00590759|OG000|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
10905522|NCT00590759|EG000|Reported Event|0502 TAG Device Subjects|
10905523|NCT00590772|BG000|Baseline|Group 1|cross over
10905524|NCT00590772|FG000|Participant Flow|Group 1|subjects were randomized to placebo or active drug and then cross over to opposite; however, the details of the randomization are no longer available.
10905525|NCT00590772|OG000|Outcome|Montelukast|
10905526|NCT00590772|OG001|Outcome|Placebo|
10905527|NCT00590772|EG000|Reported Event|Montelukast|
10905528|NCT00590772|EG001|Reported Event|Placebo|
10905529|NCT00590824|BG000|Baseline|Group A|"Hu14.18-IL2 -->Resection-->Hu14.18-IL2~hu14.18-IL2: 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by surgery and up to 2 additional courses of hu14.18-IL2"
10905530|NCT00590824|BG001|Baseline|Group B|"Resection -->Hu14.18-IL2-->Hu14.18-IL2~hu14.18-IL2: Surgery followed by 3 courses of 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course"
10905531|NCT00590824|BG002|Baseline|Group C|"Cilengitide +Hu14.18-IL2-->Resection-->Cilengitide+Hu14.18-IL2~[This Arm was suspended and subsequently removed from the study design via protocol amendment due to toxicity]"
10905532|NCT00590824|BG003|Baseline|Group D|"Cilengitide-->Resection-->Cilengitide + Hu14.18-IL2~[This Arm was suspended and subsequently removed from the study design via protocol amendment due to toxicity]"
10905533|NCT00590824|BG004|Baseline|Total|Total of all reporting groups
10905534|NCT00590824|FG000|Participant Flow|Group A|"Hu14.18-IL2 -->Resection-->Hu14.18-IL2~hu14.18-IL2: 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by surgery and up to 2 additional courses of hu14.18-IL2"
10905535|NCT00590824|FG001|Participant Flow|Group B|"Resection -->Hu14.18-IL2-->Hu14.18-IL2~hu14.18-IL2: Surgery followed by 3 courses of 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course"
10905536|NCT00590824|FG002|Participant Flow|Group C|"Cilengitide +Hu14.18-IL2-->Resection-->Cilengitide+Hu14.18-IL2~[This Arm was suspended and subsequently removed from the study design via protocol amendment due to toxicity]"
10905537|NCT00590824|FG003|Participant Flow|Group D|"Cilengitide-->Resection-->Cilengitide + Hu14.18-IL2~[This Arm was suspended and subsequently removed from the study design via protocol amendment due to toxicity]"
10905538|NCT00590824|OG000|Outcome|Group A|"Hu14.18-IL2 -->Resection-->Hu14.18-IL2~hu14.18-IL2: 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by surgery and up to 2 additional courses of hu14.18-IL2"
10905539|NCT00590824|OG001|Outcome|Group B|"Resection -->Hu14.18-IL2-->Hu14.18-IL2~hu14.18-IL2: Surgery followed by 3 courses of 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course"
10905540|NCT00590824|OG000|Outcome|Group A and B|"Hu14.18-IL2 ->Hu14.18-IL2~[All participants received same treatment]~hu14.18-IL2: 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by up to 2 additional courses of hu14.18-IL2"
10905541|NCT00590824|OG000|Outcome|Group A and B|"Hu14.18-IL2 -->Hu14.18-IL2~[All participants received the same treatment]~hu14.18-IL2: 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by up to 2 additional courses of hu14.18-IL2"
10905542|NCT00590824|EG000|Reported Event|Group A|"Hu14.18-IL2 -->Resection-->Hu14.18-IL2~hu14.18-IL2: 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by surgery and up to 2 additional courses of hu14.18-IL2"
10905543|NCT00590824|EG001|Reported Event|Group B|"Resection -->Hu14.18-IL2-->Hu14.18-IL2~hu14.18-IL2: Surgery followed by 3 courses of 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course"
10905544|NCT00590824|EG002|Reported Event|Group C|"Cilengitide +Hu14.18-IL2-->Resection-->Cilengitide+Hu14.18-IL2~[This Arm was suspended and subsequently removed from the study design via protocol amendment due to toxicity]"
10905545|NCT00590824|EG003|Reported Event|Group D|"Cilengitide-->Resection-->Cilengitide + Hu14.18-IL2~[This Arm was suspended and subsequently removed from the study design via protocol amendment due to toxicity]"
10905546|NCT00590863|BG000|Baseline|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
10905547|NCT00590863|BG001|Baseline|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
10905548|NCT00590863|BG002|Baseline|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
10905549|NCT00590863|BG003|Baseline|Total|Total of all reporting groups
10905550|NCT00590863|FG000|Participant Flow|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
10905551|NCT00590863|FG001|Participant Flow|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
10905552|NCT00590863|FG002|Participant Flow|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
10905553|NCT00590863|OG000|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
10905554|NCT00590863|OG001|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venlafaine XR + Mirtazapine for up to 28 weeks.
10905555|NCT00590863|OG002|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.~Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
11091106|NCT01532999|EG001|Reported Event|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
11091107|NCT01533038|BG000|Baseline|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
10915217|NCT00634621|EG000|Reported Event|Hexvix|Use of the Hexvix drug.
10905556|NCT00590863|OG001|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venalfaxine XR + Mirtazapine for up to 28 weeks.
10905557|NCT00590863|EG000|Reported Event|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
10905558|NCT00590863|EG001|Reported Event|Venlafaxine XR + Mirtazapine|Participants will take Venlafaxine XR + Mirtazapine for up to 28 weeks.
10905559|NCT00590863|EG002|Reported Event|Escitalopram + Placebo|Participants will take Escitalopram + Placebo for up to 28 weeks.
10915218|NCT00634647|BG000|Baseline|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
10905560|NCT00590889|BG000|Baseline|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
10905561|NCT00590889|BG001|Baseline|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
10905562|NCT00590889|BG002|Baseline|Total|Total of all reporting groups
10905563|NCT00590889|FG000|Participant Flow|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
10905564|NCT00590889|FG001|Participant Flow|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
10905565|NCT00590889|OG000|Outcome|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
10905566|NCT00590889|OG001|Outcome|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
10905567|NCT00590889|EG000|Reported Event|Adverse Events for the Conventional Group|These patients received a conventional heart valve.
10905568|NCT00590889|EG001|Reported Event|Adverse Events for the Silzone™ Group|These patients received the Silzone™ treated heart valve.
10905569|NCT00590902|BG000|Baseline|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
10905570|NCT00590902|FG000|Participant Flow|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
10905571|NCT00590902|OG000|Outcome|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
10905572|NCT00590902|EG000|Reported Event|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
10905573|NCT00590954|BG000|Baseline|Treatment|"Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.~Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.~In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4."
10905574|NCT00590954|FG000|Participant Flow|Treatment|"Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.~Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.~In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4."
10905575|NCT00590954|OG000|Outcome|Glioblastoma|"Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.~Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.~In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4."
10905576|NCT00590954|OG001|Outcome|Anaplastic Glioma|"Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.~Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.~In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4."
11172331|NCT02008877|FG001|Participant Flow|Phase 1 Dose 2|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
10905577|NCT00590954|OG000|Outcome|Treatment|"Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.~Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.~In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4."
10915219|NCT00634647|FG000|Participant Flow|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
10905578|NCT00590954|EG000|Reported Event|Treatment|"Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.~Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.~In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4."
10905579|NCT00590967|BG000|Baseline|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin 40 mg/m^2"
10905580|NCT00590967|BG001|Baseline|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
10905581|NCT00590967|BG002|Baseline|Total|Total of all reporting groups
10905582|NCT00590967|FG000|Participant Flow|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET).~Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments)~Weekly cisplatin 40 mg/m^2"
10905583|NCT00590967|FG001|Participant Flow|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
10905584|NCT00590967|OG000|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
10905585|NCT00590967|OG001|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
10905586|NCT00590967|EG000|Reported Event|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
10905587|NCT00590967|EG001|Reported Event|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
10905588|NCT00590980|BG000|Baseline|Study Participants|Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
10905589|NCT00590980|FG000|Participant Flow|All Study Participants|Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
11172332|NCT02008877|FG002|Participant Flow|Phase 2|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
11172333|NCT02008877|OG000|Outcome|Ganetespib / Sirolimus|"28-day cycles of ganetespib + sirolimus~ganetespib: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 2mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
11172334|NCT02008877|OG000|Outcome|Phase 1 Dose Level 1|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 150 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
10905590|NCT00590980|OG000|Outcome|Study Participants|Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
10905591|NCT00590980|EG000|Reported Event|Observation|Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
10905592|NCT00591006|BG000|Baseline|Total Study Population|Seventeen healthy controls, in a one-hour imaging session, received a structural MRI, MRS and fMRI scan four separate times with a 21 day washout between each study drug exposure in a crossover design. Prior to each scan each participant received placebo + placebo, phenytoin + placebo, hydrocortisone + placebo, or hydrocortisone + phenytoin in a random fashion. Thus, each participant received each of the four possible study drug combinations in a random order with an extended drug washout between each exposure. Hippocampal activation, volume and biochemistry, as well as mood and memory was assessed.
10905593|NCT00591006|FG000|Participant Flow|PH + PL Then PL + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160 mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
10915220|NCT00634647|OG000|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
10905594|NCT00591006|FG001|Participant Flow|PH + H Then PH + PL Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
10905595|NCT00591006|FG002|Participant Flow|PL + PL Then PH + PL Then PH + H Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905596|NCT00591006|FG003|Participant Flow|PL + H Then PL + PL Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours (20mg) and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905597|NCT00591006|FG004|Participant Flow|PL + H Then PH + PL Then PL + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905598|NCT00591006|FG005|Participant Flow|PL + H Then PL + PL Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
10905599|NCT00591006|FG006|Participant Flow|PL + H Then PH +H Then PH + PL Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
10905600|NCT00591006|FG007|Participant Flow|PL + H Then PH + H Then PL + PL Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
10915221|NCT00634647|EG000|Reported Event|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
10905601|NCT00591006|FG008|Participant Flow|PL + H Then PH + PL Then PH + H Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
10905602|NCT00591006|FG009|Participant Flow|PH + H Then PL + H Then PL + PL Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
10905603|NCT00591006|FG010|Participant Flow|PH + H Then PL + H Then PH + PL Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
10905604|NCT00591006|FG011|Participant Flow|PH + H Then PH + PL Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905605|NCT00591006|FG012|Participant Flow|PH + H Then PL + PL Then PH + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905606|NCT00591006|FG013|Participant Flow|PH + H Then PL + PL Then PL + H Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
10905607|NCT00591006|FG014|Participant Flow|PH + PL Then PL + PL Then PH + H Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
11172335|NCT02008877|OG001|Outcome|Phase 1 Dose Level 2|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
10905608|NCT00591006|FG015|Participant Flow|PH + PL Then PL + PL Then PL + H Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905609|NCT00591006|FG016|Participant Flow|PH + PL Then PH + H Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905610|NCT00591006|FG017|Participant Flow|PH + PL Then PH + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
10905611|NCT00591006|FG018|Participant Flow|PL + PL Then PH + PL Then PL + H Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905612|NCT00591006|FG019|Participant Flow|PL + PL Then PH + H Then PH + PL Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
11172336|NCT02008877|OG002|Outcome|Phase 2|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
10905613|NCT00591006|FG020|Participant Flow|PL + PL Then PL + H Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905614|NCT00591006|FG021|Participant Flow|PL + PL Then PL + H Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
11172337|NCT02008877|EG000|Reported Event|Phase 1 Dose 1|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 150 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
11172338|NCT02008877|EG001|Reported Event|Phase 1 Dose 2|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
11172339|NCT02008877|EG002|Reported Event|Phase 2|"For each 28-day cycle, subjects took doses of both ganetespib + sirolimus:~ganetespib: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour~Sirolimus: 4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only."
11172340|NCT02008890|BG000|Baseline|AIN457 150mg|Secukinumab 150mg at each dosing in period 1.
11172341|NCT02008890|BG001|Baseline|AIN457 300mg|Secukinumab 300mg at each dosing in period 1.
11172342|NCT02008890|BG002|Baseline|Placebo|Placebo at each dosing in period 1.
11172343|NCT02008890|BG003|Baseline|Total|Total of all reporting groups
11172344|NCT02008890|FG000|Participant Flow|AIN457 150mg|Secukinumab 150mg at each dosing.
11172345|NCT02008890|FG001|Participant Flow|AIN457 300mg|Secukinumab 300mg at each dosing.
11172346|NCT02008890|FG002|Participant Flow|Placebo|Placebo at each dosing.
11172347|NCT02008890|FG003|Participant Flow|Placebo - AIN457 150 mg|Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
11172348|NCT02008890|FG004|Participant Flow|Placebo - AIN457 300 mg|Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
11172349|NCT02008890|OG000|Outcome|AIN457 150mg|Secukinumab 150mg at each dosing.
11172350|NCT02008890|OG001|Outcome|AIN457 300mg|Secukinumab 300mg at each dosing
11172351|NCT02008890|OG002|Outcome|Placebo|Placebo at each dosing.
11172352|NCT02008890|OG003|Outcome|Placebo - AIN457 150 mg|Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
11172353|NCT02008890|OG004|Outcome|Placebo - AIN457 300 mg|Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
11172354|NCT02008890|OG002|Outcome|Placebo - AIN457 150 mg|Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
11172355|NCT02008890|OG003|Outcome|Placebo - AIN457 300 mg|Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
11172356|NCT02008890|EG000|Reported Event|Initial AIN457 150 mg|AEs for patients randomized to Secukinumab 150 mg at start of study.
11172357|NCT02008890|EG001|Reported Event|Initial AIN457 300 mg|AEs for patients randomized to Secukinumab 300 mg at start of study.
11172358|NCT02008890|EG002|Reported Event|Placebo|AEs for patients randomized to Placebo at start of study while treated with Placebo (AEs that occurred after re-randomization to Secukinumab are not counted in this group).
11172359|NCT02008890|EG003|Reported Event|AIN457 150 mg in Any Period|AEs for patients initially randomized to AIN457 150mg and placebo non-responder re-randomized to AIN457 150 mg at Week 16
11172360|NCT02008890|EG004|Reported Event|AIN457 300 mg in Any Period|AEs for patients initially randomized to AIN457 300mg and placebo non-responder re-randomized to AIN457 300 mg at Week 16
11172361|NCT02008890|EG005|Reported Event|Any AIN457|Any Secukinumab
11172362|NCT02008916|BG000|Baseline|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11172363|NCT02008916|BG001|Baseline|Secukinumab 10 mg/kg i.v. / 300 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11172364|NCT02008916|BG002|Baseline|Placebo i.v. and s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
11172365|NCT02008916|BG003|Baseline|Total|Total of all reporting groups
11172366|NCT02008916|FG000|Participant Flow|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11172367|NCT02008916|FG001|Participant Flow|Secukinumab 10 mg/kg i.v. / 300 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11172368|NCT02008916|FG002|Participant Flow|Placebo i.v. and s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, 36 patients were re-randomised to Secukinumab 150mg and 37 patients to Secukinumab 300mg until the end of the study.
11172369|NCT02008916|OG000|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11172370|NCT02008916|OG001|Outcome|Secukinumab 10 mg/kg i.v. / 300 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
11172371|NCT02008916|OG002|Outcome|Placebo i.v. and s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
11172372|NCT02008916|EG000|Reported Event|Any Secukinumab 150 mg|Includes Patients randomized to Secukinumab 150 mg at baseline + patients re-randomized to Secukinumab 150 mg at week 16 (for AEs occurring after rerandomization)
11172373|NCT02008916|EG001|Reported Event|Any Secukinumab 300 mg|Includes Patients randomized to Secukinumab 300 mg at baseline + patients re-randomized to Secukinumab 300 mg at week 16 (for AEs occurring after rerandomization)
11172374|NCT02008916|EG002|Reported Event|Any Secukinumab|Any Secukinumab 150 mg + Any Secukinumab 300 mg
11172375|NCT02008916|EG003|Reported Event|Placebo|Includes Patients randomized to Placebo for AEs until time of re-randomization (Week 16) to Secukinumab.
11172376|NCT02008942|BG000|Baseline|All Study Participants|All patients that received at least 1 dose of study drug
10905615|NCT00591006|FG022|Participant Flow|PL + PL Then PH + H Then PL + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
10905616|NCT00591006|FG023|Participant Flow|PH + PL Then PL + H Then PL + PL Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
10905617|NCT00591006|OG000|Outcome|Phenytoin&Hydrocortisone|Examining all participants for the condition in which they took both phenytoin and hydrocortisone.
10905618|NCT00591006|OG001|Outcome|Placebo&Placebo|Examining all participants for the condition in which they took placebo for both administrations.
10905619|NCT00591006|OG002|Outcome|Phenytoin&Placebo|Examining all participants for the condition in which they took phenytoin and placebo.
10905620|NCT00591006|OG003|Outcome|Placebo&Hydrocortisone|Examining all participants for the condition in which they took placebo and hydrocortisone.
10905621|NCT00591006|OG000|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
10905622|NCT00591006|OG001|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets of placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
10905623|NCT00591006|OG002|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
11172377|NCT02008942|FG000|Participant Flow|PL2200 Aspirin First, Then Enteric Coated (EC) Aspirin|"First Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days~(after 2-week washout period)~Second Intervention Period:~EC aspirin: 325 mg aspirin; once per day for 10 days"
10905624|NCT00591006|OG003|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
10905625|NCT00591006|OG001|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
10905626|NCT00591006|OG002|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
10905627|NCT00591006|OG003|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
11172378|NCT02008942|FG001|Participant Flow|Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin|"First Intervention Period:~EC aspirin: 325 mg aspirin; once per day for 10 days~(after 2-week washout period)~Second Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
11172379|NCT02008942|OG000|Outcome|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
10905628|NCT00591006|EG000|Reported Event|Phenytoin, Then Hydrocortisone|"Placebo, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
10905629|NCT00591006|EG001|Reported Event|Phenytoin, Then Placebo|"Phenytoin, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
10905630|NCT00591006|EG002|Reported Event|Placebo, Then Hydrocortisone|"Hydrocortisone, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
11172380|NCT02008942|OG001|Outcome|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
11172381|NCT02008942|EG000|Reported Event|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
11172382|NCT02008942|EG001|Reported Event|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
11172383|NCT02009046|BG000|Baseline|SEI Classroom Curriculum|"Participants receive the SEI classroom curriculum.~SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length."
11172384|NCT02009046|BG001|Baseline|Control Classroom Curriculum|"Participants receive the control classroom curriculum.~Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length."
11172385|NCT02009046|BG002|Baseline|Total|Total of all reporting groups
11172386|NCT02009046|FG000|Participant Flow|SEI Classroom Curriculum|"Participants receive the SEI classroom curriculum.~SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length."
11172387|NCT02009046|FG001|Participant Flow|Control Classroom Curriculum|"Participants receive the control classroom curriculum.~Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length."
11172388|NCT02009046|OG000|Outcome|SEI Classroom Curriculum|"Participants receive the SEI classroom curriculum.~SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length."
11172389|NCT02009046|OG001|Outcome|Control Classroom Curriculum|"Participants receive the control classroom curriculum.~Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length."
11172390|NCT02009046|OG002|Outcome|SEI Curriculum + 3 School Wide Components|"Participants receive SEI curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).~3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes clinic without walls health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed."
11172391|NCT02009046|OG003|Outcome|Control Curriculum + 1 School Wide Component|"Participants receive control curriculum and one of the three school wide components (clinical services linkages).~1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes clinic without walls health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed."
10905631|NCT00591006|EG003|Reported Event|Placebo, Then Placebo|"Hydrocortisone, Phenytoin~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
10905632|NCT00591019|BG000|Baseline|All Participants|Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition.
10905633|NCT00591019|FG000|Participant Flow|Baseline, Modafinil 200 mg/Day, Placebo|Subjects are tested at baseline, then after Modafinil (200mg/day, a.m. administration) for 14 days, then after placebo (for 14 days).
10905634|NCT00591019|FG001|Participant Flow|Baseline, Placebo, Modafinil 200 mg/Day|Subjects are tested after baseline, then after taking a sugar pill once per day in the morning for 14 days, and then after taking modafinil 200 mg/day for 14 days.
10905635|NCT00591019|OG000|Outcome|Baseline Testing.|Establish baseline levels of performance
11172392|NCT02009046|OG002|Outcome|SEI Curriculum + 3 School Wide Components|"Participants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).~3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes clinic without walls health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed."
11172393|NCT02009046|OG003|Outcome|Control Curriculum + 1 School Wide Component|"Participants receive control classroom curriculum and one of the three school wide components (clinical services linkages).~1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes clinic without walls health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed."
11172394|NCT02009046|OG002|Outcome|SEI Curriculum + 3 School Wide Components|"Participants receive the SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).~3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes clinic without walls health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed."
11172395|NCT02009046|OG003|Outcome|Control Curriculum + 1 School Wide Component|"Participants receive the control curriculum and one school wide component (clinical services linkages).~1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes clinic without walls health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed."
11172396|NCT02009046|EG000|Reported Event|SEI Classroom Curriculum|"Participants receive the SEI classroom curriculum.~SEI Classroom Curriculum: Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length."
11172397|NCT02009046|EG001|Reported Event|Control Classroom Curriculum|"Participants receive the control classroom curriculum.~Control Classroom Curriculum: Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length."
10905636|NCT00591019|OG001|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
10905637|NCT00591019|OG002|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
10905638|NCT00591019|EG000|Reported Event|Baseline Testing.|Establish baseline levels of performance
10905639|NCT00591019|EG001|Reported Event|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
10905640|NCT00591019|EG002|Reported Event|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
10905641|NCT00591123|BG000|Baseline|FOLFOX Plus 5-FU and Erlotinib|FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
10905642|NCT00591123|FG000|Participant Flow|FOLFOX Plus 5-FU and Erlotinib|FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
10905643|NCT00591123|OG000|Outcome|FOLFOX Plus 5-FU and Erlotinib|FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
10905644|NCT00591123|EG000|Reported Event|Single Arm|FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
10905645|NCT00591149|BG000|Baseline|Oxalipatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles~Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks"
10905646|NCT00591149|FG000|Participant Flow|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks~Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles"
10905647|NCT00591149|OG000|Outcome|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles~Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks"
10905648|NCT00591149|EG000|Reported Event|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks~Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles"
10905649|NCT00591214|BG000|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
10905650|NCT00591214|FG000|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
10905651|NCT00591214|OG000|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
10905652|NCT00591214|EG000|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
10905653|NCT00591240|BG000|Baseline|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
10905654|NCT00591240|BG001|Baseline|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
10905655|NCT00591240|BG002|Baseline|Total|Total of all reporting groups
11174207|NCT02020278|EG000|Reported Event|Tolvaptan|All participants enrolled first entered a 6-month follow-up trial that evaluated post-treatment safety after participation in a tolvaptan hyponatremia trial. Participants were then eligible to receive open-label tolvaptan if they had a clinical need as determined by the investigator and met the eligibility criteria for optional tolvaptan treatment during the 6-month follow-up period. In this trial, no participants qualified for treatment during the 6-month follow-up period. Daily dose levels would have included 3.75 milligrams (mg), 7.5 mg, 15 mg, 30 mg, and 60 mg.
11174208|NCT02020304|BG000|Baseline|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
10905656|NCT00591240|FG000|Participant Flow|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
10905657|NCT00591240|FG001|Participant Flow|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
10905658|NCT00591240|OG000|Outcome|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
10905659|NCT00591240|OG001|Outcome|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
10905660|NCT00591240|EG000|Reported Event|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
10905661|NCT00591240|EG001|Reported Event|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
10905662|NCT00591253|BG000|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
10905663|NCT00591253|BG001|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
10905664|NCT00591253|BG002|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
10905665|NCT00591253|BG003|Baseline|Total|Total of all reporting groups
10905666|NCT00591253|FG000|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
10905667|NCT00591253|FG001|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
10905668|NCT00591253|FG002|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
10905669|NCT00591253|OG000|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
10905670|NCT00591253|OG001|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
10905671|NCT00591253|OG002|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
10905672|NCT00591253|EG000|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
10905673|NCT00591253|EG001|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
10905674|NCT00591253|EG002|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
10905675|NCT00591266|BG000|Baseline|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905676|NCT00591266|BG001|Baseline|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905677|NCT00591266|BG002|Baseline|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905678|NCT00591266|BG003|Baseline|Total|Total of all reporting groups
10905679|NCT00591266|FG000|Participant Flow|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905680|NCT00591266|FG001|Participant Flow|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
11174209|NCT02020304|BG001|Baseline|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
11174210|NCT02020304|BG002|Baseline|Total|Total of all reporting groups
11174211|NCT02020304|FG000|Participant Flow|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
11174212|NCT02020304|FG001|Participant Flow|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
10905681|NCT00591266|FG002|Participant Flow|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905682|NCT00591266|OG000|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905683|NCT00591266|OG001|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905684|NCT00591266|OG002|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905685|NCT00591266|EG000|Reported Event|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905686|NCT00591266|EG001|Reported Event|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905687|NCT00591266|EG002|Reported Event|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
10905688|NCT00591305|BG000|Baseline|PDL+DIM Pill|"once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects~diindolylmethane (DIM): 3-month DIM~585 nm pulsed dye laser: once-time PDL"
10905689|NCT00591305|BG001|Baseline|PDL+Placebo Pill|"once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects~585 nm pulsed dye laser: once-time PDL"
10905690|NCT00591305|BG002|Baseline|Total|Total of all reporting groups
10905691|NCT00591305|FG000|Participant Flow|PDL+DIM Pill|"once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects~diindolylmethane (DIM): 3-month DIM~585 nm pulsed dye laser: once-time PDL"
10905692|NCT00591305|FG001|Participant Flow|PDL+Placebo Pill|"once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects~585 nm pulsed dye laser: once-time PDL"
10905693|NCT00591305|OG000|Outcome|Intervention|laser+dietary DIM
11174213|NCT02020304|OG000|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
11174214|NCT02020304|OG001|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
11174215|NCT02020304|EG000|Reported Event|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
10905694|NCT00591305|OG001|Outcome|Placebo|laser only without DIM
10905695|NCT00591305|OG000|Outcome|Intervention|laser+diatary DIM
10905696|NCT00591305|EG000|Reported Event|PDL+DIM Pill|once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects
10905697|NCT00591305|EG001|Reported Event|PDL+Placebo Pill|once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
10905698|NCT00591344|BG000|Baseline|1 Progressive Resistance Training|"25 PD Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
10905699|NCT00591344|BG001|Baseline|2 Flexibility Training|"25 PD subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
10905700|NCT00591344|BG002|Baseline|Total|Total of all reporting groups
10905701|NCT00591344|FG000|Participant Flow|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
10905702|NCT00591344|FG001|Participant Flow|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
10905703|NCT00591344|OG000|Outcome|Modified Fitness Counts|Baseline Assessment- off medication UPDRS part III, motor subscale score
10905704|NCT00591344|OG001|Outcome|Progressive Resistance Exercise|Baseline Assessment - off medication UPDRS part III, motor subscale score
10905705|NCT00591344|OG000|Outcome|Modified Fitness Counts|Baseline Assessment- on medication UPDRS part III, motor subscale score
10905706|NCT00591344|OG001|Outcome|Progressive Resistance Exercise|Baseline Assessment - on medication UPDRS part III, motor subscale score
10905707|NCT00591344|OG000|Outcome|Modified Fitness Counts|Baseline Assessment- L-dopa equilivent-mg/day
10905708|NCT00591344|OG001|Outcome|Progressive Resistance Exercise|Baseline Assessment- L-dopa equilivent-mg/day
10905709|NCT00591344|EG000|Reported Event|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
10905710|NCT00591344|EG001|Reported Event|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
10905711|NCT00591370|BG000|Baseline|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
10905712|NCT00591370|FG000|Participant Flow|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
10905713|NCT00591370|OG000|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
10905714|NCT00591370|EG000|Reported Event|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
10905715|NCT00591409|BG000|Baseline|Rocuronium + Placebo|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10905716|NCT00591409|BG001|Baseline|Rocuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10905717|NCT00591409|BG002|Baseline|Rocuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10905718|NCT00591409|BG003|Baseline|Rocuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10905719|NCT00591409|BG004|Baseline|Rocuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10905720|NCT00591409|BG005|Baseline|Vecuronium + Placebo|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10905721|NCT00591409|BG006|Baseline|Vecuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
11172398|NCT02009046|EG002|Reported Event|SEI Curriculum + 3 School Wide Components|"Participants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).~3 School Wide Components: Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes clinic without walls health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed."
10905722|NCT00591409|BG007|Baseline|Vecuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10905723|NCT00591409|BG008|Baseline|Vecuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10905724|NCT00591409|BG009|Baseline|Vecuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10905725|NCT00591409|BG010|Baseline|Total|Total of all reporting groups
11172399|NCT02009046|EG003|Reported Event|Control Curriculum + 1 School Wide Component|"Participants receive control classroom curriculum and one of the three school wide components (clinical services linkages).~1 School Wide Component: Participants receive one of the three school wide components, the clinical services linkages. This component includes clinic without walls health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed."
11174216|NCT02020304|EG001|Reported Event|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
11174217|NCT02020369|BG000|Baseline|FVIIa 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant): First Intervention (3 months), Second Intervention (3 months), continue cycle until end of study.
10905726|NCT00591409|FG000|Participant Flow|Rocuronium + Placebo|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10905727|NCT00591409|FG001|Participant Flow|Rocuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10905728|NCT00591409|FG002|Participant Flow|Rocuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10905729|NCT00591409|FG003|Participant Flow|Rocuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10905730|NCT00591409|FG004|Participant Flow|Rocuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10905731|NCT00591409|FG005|Participant Flow|Vecuronium + Placebo|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10905732|NCT00591409|FG006|Participant Flow|Vecuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10905733|NCT00591409|FG007|Participant Flow|Vecuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10905734|NCT00591409|FG008|Participant Flow|Vecuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10905735|NCT00591409|FG009|Participant Flow|Vecuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10905736|NCT00591409|OG000|Outcome|Rocuronium + Placebo|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10905737|NCT00591409|OG001|Outcome|Rocuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10905738|NCT00591409|OG002|Outcome|Rocuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10905739|NCT00591409|OG003|Outcome|Rocuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10905740|NCT00591409|OG004|Outcome|Rocuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10905741|NCT00591409|OG005|Outcome|Vecuronium + Placebo|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10905742|NCT00591409|OG006|Outcome|Vecuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10905743|NCT00591409|OG007|Outcome|Vecuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10905744|NCT00591409|OG008|Outcome|Vecuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10905745|NCT00591409|OG009|Outcome|Vecuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10905746|NCT00591409|EG000|Reported Event|Rocuronium + Placebo|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
10905747|NCT00591409|EG001|Reported Event|Rocuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10905748|NCT00591409|EG002|Reported Event|Rocuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
10905749|NCT00591409|EG003|Reported Event|Rocuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10905750|NCT00591409|EG004|Reported Event|Rocuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10905751|NCT00591409|EG005|Reported Event|Vecuronium + Placebo|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
11172400|NCT02009163|BG000|Baseline|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
11174218|NCT02020369|BG001|Baseline|FVIIa 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant): First Intervention (3 months), Second Intervention (3 months), continue cycle until end of study.
10905752|NCT00591409|EG006|Reported Event|Vecuronium + 0.5 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
10905753|NCT00591409|EG007|Reported Event|Vecuronium + 1.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
11174219|NCT02020369|BG002|Baseline|Total|Total of all reporting groups
10905754|NCT00591409|EG008|Reported Event|Vecuronium + 2.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
10905755|NCT00591409|EG009|Reported Event|Vecuronium + 4.0 mg/kg Sugammadex|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
10905756|NCT00591565|BG000|Baseline|Acamprosate|acamprosate tablets
10905757|NCT00591565|FG000|Participant Flow|Acamprosate|acamprosate tablets
10905758|NCT00591565|OG000|Outcome|Acamprosate|
10905759|NCT00591565|EG000|Reported Event|Acamprosate|acamprosate tablets
10905760|NCT00591578|BG000|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
10905761|NCT00591578|BG001|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
10905762|NCT00591578|BG002|Baseline|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
10905763|NCT00591578|BG003|Baseline|Total|Total of all reporting groups
10905764|NCT00591578|FG000|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
10905765|NCT00591578|FG001|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
10905766|NCT00591578|FG002|Participant Flow|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
10905767|NCT00591578|OG000|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
10905768|NCT00591578|OG001|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
10905769|NCT00591578|OG002|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
10905770|NCT00591578|EG000|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
10905771|NCT00591578|EG001|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
10905772|NCT00591578|EG002|Reported Event|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
10905773|NCT00591578|EG003|Reported Event|Open Label Extension|Azilsartan medoxomil 40 mg, tablets, orally, independent of participant's double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).
10905774|NCT00591591|BG000|Baseline|Controls|Healthy controls
10905775|NCT00591591|BG001|Baseline|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
10905776|NCT00591591|BG002|Baseline|Total|Total of all reporting groups
10905777|NCT00591591|FG000|Participant Flow|Controls|Healthy controls
10905778|NCT00591591|FG001|Participant Flow|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
10905779|NCT00591591|OG000|Outcome|Controls|Healthy controls
10905780|NCT00591591|OG001|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
10905781|NCT00591591|EG000|Reported Event|Controls|Healthy controls
10905782|NCT00591591|EG001|Reported Event|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
10905783|NCT00591630|BG000|Baseline|Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant|"Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab~Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905784|NCT00591630|BG001|Baseline|Group 1 - Zevalin + BEAM + Stem Cell Transplant|"Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant~Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905785|NCT00591630|BG002|Baseline|Group 2 - BEAM + Rituximab + Stem Cell Transplant|"BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905786|NCT00591630|BG003|Baseline|Group 2 - BEAM + Stem Cell Transplant|"BEAM + Rituximab Followed by Stem Cell Transplant~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905787|NCT00591630|BG004|Baseline|Total|Total of all reporting groups
10905788|NCT00591630|FG000|Participant Flow|Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant|"Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab~Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905789|NCT00591630|FG001|Participant Flow|Group 1 - Zevalin + BEAM + Stem Cell Transplant|"Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant~Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905790|NCT00591630|FG002|Participant Flow|Group 2 - BEAM + Rituximab + Stem Cell Transplant|"BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905791|NCT00591630|FG003|Participant Flow|Group 2 - BEAM + Stem Cell Transplant|"BEAM + Rituximab Followed by Stem Cell Transplant~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905792|NCT00591630|OG000|Outcome|Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant|"Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab~Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905793|NCT00591630|OG001|Outcome|Group 1 - Zevalin + BEAM + Stem Cell Transplant|"Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant~Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905794|NCT00591630|OG002|Outcome|Group 2 - BEAM + Rituximab + Stem Cell Transplant|"BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905795|NCT00591630|OG003|Outcome|Group 2 - BEAM + Stem Cell Transplant|"BEAM + Rituximab Followed by Stem Cell Transplant~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905796|NCT00591630|EG000|Reported Event|Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant|"Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab~Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905797|NCT00591630|EG001|Reported Event|Group 1 - Zevalin + BEAM + Stem Cell Transplant|"Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant~Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905798|NCT00591630|EG002|Reported Event|Group 2 - BEAM + Rituximab + Stem Cell Transplant|"BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905799|NCT00591630|EG003|Reported Event|Group 2 - BEAM + Stem Cell Transplant|"BEAM + Rituximab Followed by Stem Cell Transplant~Carmustine: 300 mg/m^2 by vein.~Etoposide: 200 mg/m^2 by vein every 12 hours.~Cytarabine: 200 mg/m^2 by vein every 12 hours.~Melphalan: 140 mg/m^2 by vein.~Rituximab: Arm 1, Arm 2 = 250 mg/m^2 by vein;~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.~Stem Cell Transplant: Injection of stem cells (Autologous SCT)"
10905800|NCT00591721|BG000|Baseline|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
10905801|NCT00591721|BG001|Baseline|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
10905802|NCT00591721|BG002|Baseline|Total|Total of all reporting groups
10905803|NCT00591721|FG000|Participant Flow|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
10905804|NCT00591721|FG001|Participant Flow|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
10905805|NCT00591721|OG000|Outcome|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
10905806|NCT00591721|OG001|Outcome|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
10905807|NCT00591721|EG000|Reported Event|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
10905808|NCT00591721|EG001|Reported Event|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
10905809|NCT00591734|BG000|Baseline|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
10905810|NCT00591734|FG000|Participant Flow|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
10905811|NCT00591734|OG000|Outcome|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
10905812|NCT00591734|EG000|Reported Event|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
10905813|NCT00591760|BG000|Baseline|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
10905814|NCT00591760|BG001|Baseline|Control|Optimal CHF treatment
10905815|NCT00591760|BG002|Baseline|Total|Total of all reporting groups
10905816|NCT00591760|FG000|Participant Flow|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
10905817|NCT00591760|FG001|Participant Flow|Control|Optimal CHF treatment
10905818|NCT00591760|OG000|Outcome|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
10905819|NCT00591760|OG001|Outcome|Control|Optimal CHF treatment
10905820|NCT00591760|EG000|Reported Event|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
10905821|NCT00591760|EG001|Reported Event|Control|Optimal CHF treatment
10905822|NCT00591773|BG000|Baseline|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905823|NCT00591773|BG001|Baseline|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905824|NCT00591773|BG002|Baseline|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905825|NCT00591773|BG003|Baseline|Total|Total of all reporting groups
10905826|NCT00591773|FG000|Participant Flow|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905827|NCT00591773|FG001|Participant Flow|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905828|NCT00591773|FG002|Participant Flow|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905829|NCT00591773|OG000|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
11174220|NCT02020369|FG000|Participant Flow|FVIIa: 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
11174221|NCT02020369|FG001|Participant Flow|FVIIa: 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant): Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
10905830|NCT00591773|OG001|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905831|NCT00591773|OG002|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905832|NCT00591773|EG000|Reported Event|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905833|NCT00591773|EG001|Reported Event|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905834|NCT00591773|EG002|Reported Event|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
10905835|NCT00591786|BG000|Baseline|Sugammadex 0.5 mg/kg (Rocuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905836|NCT00591786|BG001|Baseline|Sugammadex 1.0 mg/kg (Rocuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905837|NCT00591786|BG002|Baseline|Sugammadex 2.0 mg/kg (Rcocuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905838|NCT00591786|BG003|Baseline|Sugammadex 4.0 mg/kg (Rocuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905839|NCT00591786|BG004|Baseline|Sugammadex 8.0 mg/kg (Rocuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905840|NCT00591786|BG005|Baseline|Sugammadex 0.5 mg/kg (Vecuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905841|NCT00591786|BG006|Baseline|Sugammadex 1.0 mg/kg (Vecuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905842|NCT00591786|BG007|Baseline|Sugammadex 2.0 mg/kg (Vecuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905843|NCT00591786|BG008|Baseline|Sugammadex 4.0 mg/kg (Vecuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905844|NCT00591786|BG009|Baseline|Sugammadex 8.0 mg/kg (Vecuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
11172401|NCT02009163|FG000|Participant Flow|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
11172402|NCT02009163|FG001|Participant Flow|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
11172403|NCT02009163|FG002|Participant Flow|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
11172404|NCT02009163|OG000|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
10905845|NCT00591786|BG010|Baseline|Total|Total of all reporting groups
10905846|NCT00591786|FG000|Participant Flow|Sugammadex 0.5 mg/kg (Rocuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905847|NCT00591786|FG001|Participant Flow|Sugammadex 1.0 mg/kg (Rocuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905848|NCT00591786|FG002|Participant Flow|Sugammadex 2.0 mg/kg (Rocuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905849|NCT00591786|FG003|Participant Flow|Sugammadex 4.0 mg/kg (Rocuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905850|NCT00591786|FG004|Participant Flow|Sugammadex 8.0 mg/kg (Rocuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905851|NCT00591786|FG005|Participant Flow|Sugammadex 0.5 mg/kg (Vecuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905852|NCT00591786|FG006|Participant Flow|Sugammadex 1.0 mg/kg (Vecuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
11172405|NCT02009163|OG001|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
11172406|NCT02009163|OG001|Outcome|SPD489 (Randomized--Withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70 mg was continued throughout the 26-week double-blind randomized--withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
11172407|NCT02009163|OG000|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
11174222|NCT02020369|OG000|Outcome|FVIIa 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
10905853|NCT00591786|FG007|Participant Flow|Sugammadex 2.0 mg/kg (Vecuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905854|NCT00591786|FG008|Participant Flow|Sugammadex 4.0 mg/kg (Vecuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905855|NCT00591786|FG009|Participant Flow|Sugammadex 8.0 mg/kg (Vecuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905856|NCT00591786|OG000|Outcome|Sugammadex 0.5 mg/kg (Rocuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905857|NCT00591786|OG001|Outcome|Sugammadex 1.0 mg/kg (Rocuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905858|NCT00591786|OG002|Outcome|Sugammadex 2.0 mg/kg (Rocuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905859|NCT00591786|OG003|Outcome|Sugammadex 4.0 mg/kg (Rocuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905860|NCT00591786|OG004|Outcome|Sugammadex 8.0 mg/kg (Rocuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905861|NCT00591786|OG005|Outcome|Sugammadex 0.5 mg/kg (Vecuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905862|NCT00591786|OG006|Outcome|Sugammadex 1.0 mg/kg (Vecuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905863|NCT00591786|OG007|Outcome|Sugammadex 2.0 mg/kg (Vecuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905864|NCT00591786|OG008|Outcome|Sugammadex 4.0 mg/kg (Vecuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905865|NCT00591786|OG009|Outcome|Sugammadex 8.0 mg/kg (Vecuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905866|NCT00591786|EG000|Reported Event|Sugammadex 0.5 mg/kg (Rocuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905867|NCT00591786|EG001|Reported Event|Sugammadex 1.0 mg/kg (Rocuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905868|NCT00591786|EG002|Reported Event|Sugammadex 2.0 mg/kg (Rocuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905869|NCT00591786|EG003|Reported Event|Sugammadex 4.0 mg/kg (Rocuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905870|NCT00591786|EG004|Reported Event|Sugammadex 8.0 mg/kg (Rocuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
10905871|NCT00591786|EG005|Reported Event|Sugammadex 0.5 mg/kg (Vecuronium)|Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905872|NCT00591786|EG006|Reported Event|Sugammadex 1.0 mg/kg (Vecuronium)|Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905873|NCT00591786|EG007|Reported Event|Sugammadex 2.0 mg/kg (Vecuronium)|Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905874|NCT00591786|EG008|Reported Event|Sugammadex 4.0 mg/kg (Vecuronium)|Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
11172408|NCT02009163|OG000|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label phase and who had a post-baseline safety assessment.
10905875|NCT00591786|EG009|Reported Event|Sugammadex 8.0 mg/kg (Vecuronium)|Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary
10905876|NCT00591825|BG000|Baseline|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
10905877|NCT00591825|BG001|Baseline|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
10905878|NCT00591825|BG002|Baseline|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
10905879|NCT00591825|BG003|Baseline|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
10905880|NCT00591825|BG004|Baseline|Total|Total of all reporting groups
10905881|NCT00591825|FG000|Participant Flow|Non-Phobic Control - Placebo|Participants without phobia given one administration placebo.
10905882|NCT00591825|FG001|Participant Flow|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
10905883|NCT00591825|FG002|Participant Flow|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
10905884|NCT00591825|FG003|Participant Flow|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
10905885|NCT00591825|OG000|Outcome|DCS Phobic|Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
10905886|NCT00591825|OG001|Outcome|DCS Control|Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
10905887|NCT00591825|OG002|Outcome|Placebo Phobic|Participants with phobia who were randomized to the Placebo group were given one administration of placebo.
10905888|NCT00591825|OG003|Outcome|Placebo Control|Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
10905889|NCT00591825|OG000|Outcome|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
10905890|NCT00591825|OG001|Outcome|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
10905891|NCT00591825|OG002|Outcome|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
10905892|NCT00591825|OG003|Outcome|Spider-phobic DCS|Participants without phobia given one administration of 100 mg D-cycloserine.
10905893|NCT00591825|OG003|Outcome|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
10905894|NCT00591825|OG000|Outcome|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
10905895|NCT00591825|OG001|Outcome|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
10905896|NCT00591825|OG002|Outcome|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
10905897|NCT00591825|OG003|Outcome|Spider-phobic DCS|Participants with phobia were given one administration 100 mg placebo.
10905898|NCT00591825|OG003|Outcome|Spider-phobic DCS|Participants with phobia were given one administration 100 mg D-cycloserine (DCS).
10905899|NCT00591825|EG000|Reported Event|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
10905900|NCT00591825|EG001|Reported Event|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
10905901|NCT00591825|EG002|Reported Event|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
10905902|NCT00591825|EG003|Reported Event|Spider-phobic DCS|Participants with phobia were given one administration 100 mg D-cycloserine (DCS).
10905903|NCT00591838|BG000|Baseline|Phase I Dose Level A: SBRT 9Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 9Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905904|NCT00591838|BG001|Baseline|Phase I Dose Level B: SBRT 10Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 10Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905905|NCT00591838|BG002|Baseline|Phase I Dose Level C: SBRT 11Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905906|NCT00591838|BG003|Baseline|Phase I Dose Level D: SBRT 12Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 12Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905907|NCT00591838|BG004|Baseline|Phase II: SBRT 11Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week. The phase II dose was determined during the phase I portion of the study.
10905908|NCT00591838|BG005|Baseline|Total|Total of all reporting groups
10905909|NCT00591838|FG000|Participant Flow|Phase I Dose Level A: SBRT 9Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 9Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905910|NCT00591838|FG001|Participant Flow|Phase I Dose Level B: SBRT 10Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 10Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905911|NCT00591838|FG002|Participant Flow|Phase I Dose Level C: SBRT 11Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905912|NCT00591838|FG003|Participant Flow|Phase I Dose Level D: SBRT 12Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 12Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905913|NCT00591838|FG004|Participant Flow|Phase II: SBRT 11Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week. The phase II dose was determined during the phase I portion of the study.
10905914|NCT00591838|OG000|Outcome|Phase I: Stereotactic Body Radiation (SBRT)|"SBRT~Dose Level A 9Gy x 5 fractions~Dose Level B 10 Gy x 5 fractions~Dose Level C 11 Gy x 5 fractions~Dose Level D 12 Gy x 5 fractions"
10905915|NCT00591838|OG000|Outcome|Phase I Dose Level A: SBRT 9Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 9Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905916|NCT00591838|OG001|Outcome|Phase I Dose Level B: SBRT 10Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 10Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905917|NCT00591838|OG002|Outcome|Phase I Dose Level C: SBRT 11Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905918|NCT00591838|OG003|Outcome|Phase I Dose Level D: SBRT 12Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 12Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905919|NCT00591838|OG000|Outcome|Phase II: SBRT 11Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week. The phase II dose was determined during the phase I portion of the study.
11174223|NCT02020369|OG001|Outcome|FVIIa 225µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
10905920|NCT00591838|EG000|Reported Event|Phase I Dose Level A: SBRT 9Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 9Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905921|NCT00591838|EG001|Reported Event|Phase I Dose Level B: SBRT 10Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 10Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905922|NCT00591838|EG002|Reported Event|Phase I Dose Level C: SBRT 11Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905923|NCT00591838|EG003|Reported Event|Phase I Dose Level D: SBRT 12Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 12Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.
10905924|NCT00591838|EG004|Reported Event|Phase II: SBRT 11Gy x 5 Fractions|-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week. The phase II dose was determined during the phase I portion of the study.
10905925|NCT00591851|BG000|Baseline|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
10905926|NCT00591851|FG000|Participant Flow|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
10905927|NCT00591851|OG000|Outcome|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
10905928|NCT00591851|EG000|Reported Event|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
10905929|NCT00591864|BG000|Baseline|Study Participants|There are no arms or subgroups in this study.
10905930|NCT00591864|FG000|Participant Flow|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
10905931|NCT00591864|OG000|Outcome|Study Participants|There are no arms or subgroups in this study.
10905932|NCT00591864|OG000|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
10905933|NCT00591864|EG000|Reported Event|Study Participants|There are no arms or subgroups in this study.
10905934|NCT00591942|BG000|Baseline|Group 1|Note only one group is listed since EACH subject received TWO crowns. AS cross-over design, ONE crown had the VivaGlass cement and the second crown (in the same subject) had the Multi-link cement.
10905935|NCT00591942|FG000|Participant Flow|VivaGlass Cement|Cross over design, two crowns per subject, one crown cemented with VivaGlass/subject
10905936|NCT00591942|FG001|Participant Flow|Multilink Cement|Cross over design, two crowns per subject, one crown cemented with Multilink/subject
10905937|NCT00591942|OG000|Outcome|Ivoclar Vivaglass CEM IC Cement|Ivoclar Vivaglass CEM IC cement for ceramic crowns and 3-unit dental bridge
10905938|NCT00591942|OG001|Outcome|Ivoclar/Vivadent Composite Resin Cement|Ivoclar/Vivadent Composite Resin Cement for ceramic crowns and 3-unit dental bridge
10905939|NCT00591942|EG000|Reported Event|Ivoclar Vivaglass CEM IC|Ivoclar Vivaglass CEM IC cement for ceramic crowns and 3-unit dental bridge
10905940|NCT00591942|EG001|Reported Event|Ivoclar/Vivadent Composite Resin|Ivoclar/Vivadent Composite Resin Cement for ceramic crowns and 3-unit dental bridge
10905941|NCT00592072|BG000|Baseline|Overall Number of Subjects|12 subjects started the study and 10 completed the study, however 11 subjects are reported in the baseline characteristics because one subjects withdrew before baseline data was collected.
10905942|NCT00592072|FG000|Participant Flow|MCT Intervention First, Then Placebo|A total of 40 grams of medium-chain triglycerides (derived from coconut oil containing 67% octanoate, 27% decanaote, and 6% other fatty acids) is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
10905943|NCT00592072|FG001|Participant Flow|Placebo Intervention First, Then MCT Intervention|A total of 40 grams of cherry-flavored water sweetened with sucralose is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
10905944|NCT00592072|OG000|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
10905945|NCT00592072|OG001|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
10905946|NCT00592072|EG000|Reported Event|MCT Intervention|
10905947|NCT00592072|EG001|Reported Event|Placebo Intervention|
10905948|NCT00592124|BG000|Baseline|O, V, OV|"Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905949|NCT00592124|BG001|Baseline|V, O, OV|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905950|NCT00592124|BG002|Baseline|OV, O, V|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905951|NCT00592124|BG003|Baseline|OV, V, O|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905952|NCT00592124|BG004|Baseline|O, OV, V|"Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905953|NCT00592124|BG005|Baseline|V, OV, O|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905954|NCT00592124|BG006|Baseline|Total|Total of all reporting groups
10905955|NCT00592124|FG000|Participant Flow|O, V, OV|"Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905956|NCT00592124|FG001|Participant Flow|V, O, OV|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905957|NCT00592124|FG002|Participant Flow|OV, O, V|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905958|NCT00592124|FG003|Participant Flow|OV, V, O|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905959|NCT00592124|FG004|Participant Flow|O, OV, V|"Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905960|NCT00592124|FG005|Participant Flow|V, OV, O|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
10905961|NCT00592124|OG000|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
10905962|NCT00592124|OG001|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
10905963|NCT00592124|OG002|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
10905964|NCT00592124|OG000|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
11172409|NCT02009163|EG000|Reported Event|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
10905965|NCT00592124|OG001|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
10905966|NCT00592124|EG000|Reported Event|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
10905967|NCT00592124|EG001|Reported Event|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
10905968|NCT00592124|EG002|Reported Event|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
10915091|NCT00634049|OG003|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
10915092|NCT00634049|OG004|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
10915093|NCT00634049|OG005|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who have had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium,2 Exophiala,2 Cladosporium,2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia,Exserohilum, Paecilomyces,Pseudallescheria and Scedosporium).
10915094|NCT00634049|OG007|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who have had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes,9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
10915095|NCT00634049|OG008|Outcome|mITT- Other Non-Candida Yeast|Other Non Candida Yeast mITT population consisted of 11 participants who have had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus NOS and 2 Trichosporon).
10915096|NCT00634049|OG000|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
10915097|NCT00634049|OG003|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
11172410|NCT02009163|EG001|Reported Event|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week .
10905969|NCT00592176|BG000|Baseline|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
11172411|NCT02009163|EG002|Reported Event|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
11172412|NCT02009332|BG000|Baseline|Phase 1: ABI-009 100 mg/Week|Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11172413|NCT02009332|BG001|Baseline|Phase 1: ABI-009 200 mg/Week|Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
10905970|NCT00592176|FG000|Participant Flow|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
10905971|NCT00592176|OG000|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
10905972|NCT00592176|EG000|Reported Event|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
10905973|NCT00592319|BG000|Baseline|Control|"treated with routine surgery (CO2 laser or cold microsurgery), in 15 cases"
10905974|NCT00592319|BG001|Baseline|Experimental|treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases
10905975|NCT00592319|BG002|Baseline|Total|Total of all reporting groups
10905976|NCT00592319|FG000|Participant Flow|Control|"once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or cold surgery with micro-instruments), in 15 subjects"
10905977|NCT00592319|FG001|Participant Flow|Experimental|once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months
10905978|NCT00592319|OG000|Outcome|Control|treated with once-time routine surgery
10905979|NCT00592319|OG001|Outcome|Experiment|treated with both of once-time PDL and 9-month Celebrex
10905980|NCT00592319|OG000|Outcome|Control|"treated with once-time routine surgery (CO2 laser or cold microsurgery)"
10905981|NCT00592319|OG001|Outcome|Experienment|treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months
10905982|NCT00592319|EG000|Reported Event|Experiment|treated with both of PDL and Celecoxib
10905983|NCT00592319|EG001|Reported Event|Control|treatd with CO2 laser or microsurgery
10905984|NCT00592358|BG000|Baseline|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
10905985|NCT00592358|FG000|Participant Flow|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
10905986|NCT00592358|OG000|Outcome|Paliperidone|Open-label treatment with Paliperidone.
10905987|NCT00592358|EG000|Reported Event|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
10905988|NCT00592384|BG000|Baseline|Placebo Control|placebo: identically encapsulated inactive substance
10905989|NCT00592384|BG001|Baseline|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
10905990|NCT00592384|BG002|Baseline|Total|Total of all reporting groups
10905991|NCT00592384|FG000|Participant Flow|Placebo Control|placebo: identically encapsulated inactive substance
10905992|NCT00592384|FG001|Participant Flow|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
10905993|NCT00592384|OG000|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
10905994|NCT00592384|OG001|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
10905995|NCT00592384|EG000|Reported Event|Placebo Control|placebo: identically encapsulated inactive substance
10905996|NCT00592384|EG001|Reported Event|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
10905997|NCT00592475|BG000|Baseline|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
10905998|NCT00592475|BG001|Baseline|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
10905999|NCT00592475|BG002|Baseline|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
10906000|NCT00592475|BG003|Baseline|Total|Total of all reporting groups
10906001|NCT00592475|FG000|Participant Flow|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
10906002|NCT00592475|FG001|Participant Flow|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
10906003|NCT00592475|FG002|Participant Flow|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
10906004|NCT00592475|OG000|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
10906005|NCT00592475|OG001|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
10906006|NCT00592475|OG002|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
10906007|NCT00592475|EG000|Reported Event|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
10906008|NCT00592475|EG001|Reported Event|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
10906009|NCT00592475|EG002|Reported Event|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
10906010|NCT00592488|BG000|Baseline|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
10906011|NCT00592488|BG001|Baseline|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
10906012|NCT00592488|BG002|Baseline|Total|Total of all reporting groups
10906013|NCT00592488|FG000|Participant Flow|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
10906014|NCT00592488|FG001|Participant Flow|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
10906015|NCT00592488|OG000|Outcome|Acetyl-L-Carnitine (ALC) Then Placebo|ALC for hours 0-12 and placebo hours 12-18
10906016|NCT00592488|OG001|Outcome|Placebo Then Acetyl-L-Carnitine (ALC)|Placebo for hours 0-6 then ALC for hours 6-18
10906017|NCT00592488|OG000|Outcome|Placebo Then ALC|"Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours~Acetyl-L-Carnitine: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours"
10906018|NCT00592488|OG001|Outcome|ALC Then Placebo|"Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours~Acetyl-L-Carnitine: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours"
10906019|NCT00592488|EG000|Reported Event|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
10906020|NCT00592488|EG001|Reported Event|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
10906021|NCT00592501|BG000|Baseline|Proton/Photon Radiotherapy, Cisplatin, Fluorouracil|"Proton/Photon Radiotherapy: Given once a day, five days a week, for seven weeks.~Cisplatin: Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.~Fluorouracil: Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy."
10906022|NCT00592501|FG000|Participant Flow|Proton/Photon Radiotherapy, Cisplatin, Fluorouracil|"Proton/Photon Radiotherapy: Given once a day, five days a week, for seven weeks.~Cisplatin: Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.~Fluorouracil: Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy."
10906023|NCT00592501|OG000|Outcome|Proton/Photon Radiotherapy, Cisplatin, Fluorouracil|"Proton/Photon Radiotherapy: Given once a day, five days a week, for seven weeks.~Cisplatin: Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.~Fluorouracil: Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy."
10906024|NCT00592501|EG000|Reported Event|Proton/Photon Radiotherapy, Cisplatin, Fluorouracil|"Proton/Photon Radiotherapy: Given once a day, five days a week, for seven weeks.~Cisplatin: Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.~Fluorouracil: Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy."
10906025|NCT00592553|BG000|Baseline|High-Dose Ataluren|Participants received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for 48 weeks.
10906026|NCT00592553|BG001|Baseline|Low-Dose Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
10906027|NCT00592553|BG002|Baseline|Placebo|Participants received placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
10906028|NCT00592553|BG003|Baseline|Total|Total of all reporting groups
10906029|NCT00592553|FG000|Participant Flow|High-Dose Ataluren|Participants received ataluren suspension orally 3 times a day (TID), 20 milligrams/kilogram (mg/kg) at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for 48 weeks.
10906030|NCT00592553|FG001|Participant Flow|Low-Dose Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
10906031|NCT00592553|FG002|Participant Flow|Placebo|Participants received placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
10906032|NCT00592553|OG000|Outcome|High-Dose Ataluren|Participants received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for 48 weeks.
10906033|NCT00592553|OG001|Outcome|Low-Dose Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
10906034|NCT00592553|OG002|Outcome|Placebo|Participants received placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
10906035|NCT00592553|EG000|Reported Event|High-Dose Ataluren|Participants received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for 48 weeks.
10906036|NCT00592553|EG001|Reported Event|Low-Dose Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
10906037|NCT00592553|EG002|Reported Event|Placebo|Participants received placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
10906038|NCT00592631|BG000|Baseline|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
10906039|NCT00592631|BG001|Baseline|Sham|Subjects used SHAM set at 0-2 cmH20 for 7-10 nights
10906040|NCT00592631|BG002|Baseline|Total|Total of all reporting groups
10906041|NCT00592631|FG000|Participant Flow|Continuous Positivie Airway Pressure|Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment.
10906042|NCT00592631|FG001|Participant Flow|Sham Treatment|Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment.
10906043|NCT00592631|OG000|Outcome|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
10906044|NCT00592631|OG001|Outcome|Sham|Subjects used sham set at 0-2 cmH20 for 7-10 nights
10906045|NCT00592631|EG000|Reported Event|Continuous Positive Airway Pressure|
10906046|NCT00592631|EG001|Reported Event|Sham|
10906047|NCT00592683|BG000|Baseline|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
10906048|NCT00592683|BG001|Baseline|Aripiprazole + Placebo|treatment with aripiprazole + placebo
10906049|NCT00592683|BG002|Baseline|Total|Total of all reporting groups
10906050|NCT00592683|FG000|Participant Flow|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
10906051|NCT00592683|FG001|Participant Flow|Aripiprazole + Placebo|treatment with aripiprazole + placebo
10906052|NCT00592683|OG000|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
10906053|NCT00592683|OG001|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
10906054|NCT00592683|EG000|Reported Event|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
10906055|NCT00592683|EG001|Reported Event|Aripiprazole + Placebo|treatment with aripiprazole + placebo
10906056|NCT00592761|BG000|Baseline|Entire Study Population|This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.
10906057|NCT00592761|FG000|Participant Flow|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
10906058|NCT00592761|FG001|Participant Flow|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
10906059|NCT00592761|OG000|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
11172414|NCT02009332|BG002|Baseline|Phase 1: ABI-009 100 mg 2x/Week|Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks
11172415|NCT02009332|BG003|Baseline|Phase 1: ABI-009 300 mg/Week|Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11172416|NCT02009332|BG004|Baseline|Phase 1: ABI-009 400 mg/Week|Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11172417|NCT02009332|BG005|Baseline|Phase 2, Efficacy|ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks
11172418|NCT02009332|BG006|Baseline|Total|Total of all reporting groups
11172419|NCT02009332|FG000|Participant Flow|Phase 1: ABI-009 100 mg/Week|Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11172420|NCT02009332|FG001|Participant Flow|Phase 1: ABI-009 200 mg/Week|Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11172421|NCT02009332|FG002|Participant Flow|Phase 1: ABI-009 100 mg 2×/Week|Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks
11172422|NCT02009332|FG003|Participant Flow|Phase 1: ABI-009 300 mg/Week|Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11172423|NCT02009332|FG004|Participant Flow|Phase 1: ABI-009 400 mg/Week|Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
10906060|NCT00592761|OG001|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
11172424|NCT02009332|FG005|Participant Flow|Phase 2: ABI-009 200 mg/Week + Gemcitabine 2000 mg/Week|ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks
11172425|NCT02009332|OG000|Outcome|Phase 1: ABI-009 100 mg/Week|"Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks~ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm."
11172426|NCT02009332|OG001|Outcome|Phase 1: ABI-009 200 mg/Week|"Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks~ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm."
11172427|NCT02009332|OG002|Outcome|Phase 1: ABI-009 100 mg 2×/Week|"Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks~ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm."
11172428|NCT02009332|OG003|Outcome|Phase 1: ABI-009 300 mg/Week|"Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks~ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm."
11172429|NCT02009332|OG004|Outcome|Phase 1: ABI-009 400 mg/Week|"Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks~ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm."
11172430|NCT02009332|OG000|Outcome|Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week|ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks
11172431|NCT02009332|EG000|Reported Event|Phase 1: ABI-009 100 mg/Week|Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11172432|NCT02009332|EG001|Reported Event|Phase 1: ABI-009 200 mg/Week|Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11172433|NCT02009332|EG002|Reported Event|Phase 1: ABI-009 100 mg 2×/Week|Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks
11172434|NCT02009332|EG003|Reported Event|Phase 1: ABI-009 300 mg/Week|Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
11174224|NCT02020369|OG000|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
10906061|NCT00592761|EG000|Reported Event|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
10906062|NCT00592761|EG001|Reported Event|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
11172435|NCT02009332|EG004|Reported Event|Phase 1: ABI-009 400 mg/Week|Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
10906063|NCT00592774|BG000|Baseline|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
10906064|NCT00592774|BG001|Baseline|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 3-week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
10906065|NCT00592774|BG002|Baseline|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
10906066|NCT00592774|BG003|Baseline|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
10906067|NCT00592774|BG004|Baseline|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
10906068|NCT00592774|BG005|Baseline|Total|Total of all reporting groups
10906069|NCT00592774|FG000|Participant Flow|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
10906070|NCT00592774|FG001|Participant Flow|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 3-week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
10906071|NCT00592774|FG002|Participant Flow|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
10906072|NCT00592774|FG003|Participant Flow|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
10906073|NCT00592774|FG004|Participant Flow|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
11172436|NCT02009332|EG005|Reported Event|Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week|ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks
11172437|NCT02009397|BG000|Baseline|Ipilimumab and GM-CSF|"IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles~Ipilimumab~GM-CSF"
10906074|NCT00592774|OG000|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
10906075|NCT00592774|OG001|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 3-week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
10906076|NCT00592774|OG002|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
10906077|NCT00592774|OG003|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
10906078|NCT00592774|OG004|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
10906079|NCT00592774|EG000|Reported Event|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
10906080|NCT00592774|EG001|Reported Event|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 3-week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
10906081|NCT00592774|EG002|Reported Event|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
10906082|NCT00592774|EG003|Reported Event|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
10906083|NCT00592774|EG004|Reported Event|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
10906084|NCT00592839|BG000|Baseline|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
10906085|NCT00592839|BG001|Baseline|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
10906086|NCT00592839|BG002|Baseline|Placebo Daily|Placebo tablet daily orally
10906087|NCT00592839|BG003|Baseline|Total|Total of all reporting groups
10906088|NCT00592839|FG000|Participant Flow|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
10906089|NCT00592839|FG001|Participant Flow|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
10906090|NCT00592839|FG002|Participant Flow|Placebo Daily|Placebo tablet daily orally
10906091|NCT00592839|OG000|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
10906092|NCT00592839|OG001|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
10906093|NCT00592839|OG002|Outcome|Placebo Daily|Placebo tablet daily orally
10906094|NCT00592839|EG000|Reported Event|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
10906095|NCT00592839|EG001|Reported Event|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
10906096|NCT00592839|EG002|Reported Event|Placebo Daily|Placebo tablet daily orally
10906097|NCT00592852|BG000|Baseline|Fluoxetine|
10906098|NCT00592852|FG000|Participant Flow|Fluoxetine|
10906099|NCT00592852|OG000|Outcome|Fluoxetine|
10906100|NCT00592852|EG000|Reported Event|Fluoxetine|
10906101|NCT00592904|BG000|Baseline|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906102|NCT00592904|BG001|Baseline|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906103|NCT00592904|BG002|Baseline|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906104|NCT00592904|BG003|Baseline|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906105|NCT00592904|BG004|Baseline|Total|Total of all reporting groups
10906106|NCT00592904|FG000|Participant Flow|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906107|NCT00592904|FG001|Participant Flow|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906108|NCT00592904|FG002|Participant Flow|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906109|NCT00592904|FG003|Participant Flow|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906110|NCT00592904|OG000|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906111|NCT00592904|OG001|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906112|NCT00592904|OG002|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906113|NCT00592904|OG003|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
10906114|NCT00592904|EG000|Reported Event|Placebo|The participants who had previously received placebo during the double-blind study.
10906115|NCT00592904|EG001|Reported Event|Perampanel|The participants that had previously received perampanel during the double-blind study.
10906116|NCT00592904|EG002|Reported Event|Painful Diabetic Neuropathy|The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel.
10906117|NCT00592904|EG003|Reported Event|Post Herpetic Neuralgia|The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel.
10906118|NCT00592943|BG000|Baseline|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
10906119|NCT00592943|BG001|Baseline|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
10906120|NCT00592943|BG002|Baseline|Total|Total of all reporting groups
10906121|NCT00592943|FG000|Participant Flow|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
10906122|NCT00592943|FG001|Participant Flow|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
10906123|NCT00592943|OG000|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
10906124|NCT00592943|OG001|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
10906125|NCT00592943|EG000|Reported Event|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
10906126|NCT00592943|EG001|Reported Event|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
10906127|NCT00593112|BG000|Baseline|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
10906128|NCT00593112|BG001|Baseline|Control|Healthy Volunteer Control group
10906129|NCT00593112|BG002|Baseline|Total|Total of all reporting groups
10906130|NCT00593112|FG000|Participant Flow|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
10906131|NCT00593112|FG001|Participant Flow|Control|Healthy Volunteer Control group
11172438|NCT02009397|FG000|Participant Flow|Ipilimumab and GM-CSF|"IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles~Ipilimumab~GM-CSF"
11172439|NCT02009397|OG000|Outcome|Ipilimumab and GM-CSF|"IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles~Ipilimumab~GM-CSF"
11172440|NCT02009397|EG000|Reported Event|Ipilimumab and GM-CSF|"IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles~Ipilimumab~GM-CSF"
11172441|NCT02009501|BG000|Baseline|VAC Ulta Therapy|VAC ULTA Therapy applied in the OR after surgical debridement.
11172442|NCT02009501|BG001|Baseline|VAC VeraFlo With Dakins Instillation|VAC VeraFlo with Dakins Instillation.0.125% instillation applied in the OR after surgical debridement.
11172443|NCT02009501|BG002|Baseline|Total|Total of all reporting groups
11172444|NCT02009501|FG000|Participant Flow|VAC Ulta Therapy|VAC ULTA Therapy applied in the OR after surgical debridement.
11172445|NCT02009501|FG001|Participant Flow|VAC VeraFlo With Dakins Instillation|VAC VeraFlo with Dakins Instillation.0.125% instillation applied in the OR after surgical debridement.
11172446|NCT02009501|OG000|Outcome|VAC Ulta Therapy|VAC ULTA Therapy applied in the OR after surgical debridement.
11172447|NCT02009501|OG001|Outcome|VAC VeraFlo With Dakins Instillation|VAC VeraFlo with Dakins Instillation.0.125% instillation applied in the OR after surgical debridement.
11172448|NCT02009501|EG000|Reported Event|VAC Ulta Therapy|VAC ULTA Therapy applied in the OR after surgical debridement.
11172449|NCT02009501|EG001|Reported Event|VAC VeraFlo With Dakins Instillation|VAC VeraFlo with Dakins Instillation.0.125% instillation applied in the OR after surgical debridement.
11172450|NCT02009696|BG000|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
11172451|NCT02009696|FG000|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
11172452|NCT02009696|OG000|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
11172453|NCT02009696|EG000|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
11172454|NCT02009722|BG000|Baseline|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
11172455|NCT02009722|BG001|Baseline|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
11172456|NCT02009722|BG002|Baseline|Total|Total of all reporting groups
11172457|NCT02009722|FG000|Participant Flow|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
11172458|NCT02009722|FG001|Participant Flow|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
11172459|NCT02009722|OG000|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
11172460|NCT02009722|OG001|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
11174225|NCT02020369|OG001|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
11174226|NCT02020369|OG000|Outcome|Factor VIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
10906132|NCT00593112|OG000|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
10906133|NCT00593112|OG001|Outcome|Control|Healthy Volunteer Control group
10906134|NCT00593112|EG000|Reported Event|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
10906135|NCT00593112|EG001|Reported Event|Control|Healthy Volunteer Control group
10906136|NCT00593333|BG000|Baseline|Standard Treatment|Pirformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail or an Antegrade Femoral Nail.
10906137|NCT00593333|BG001|Baseline|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
10906138|NCT00593333|BG002|Baseline|Total|Total of all reporting groups
10906139|NCT00593333|FG000|Participant Flow|Standard Treatment|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
10906140|NCT00593333|FG001|Participant Flow|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
10906141|NCT00593333|OG000|Outcome|Standard Treatment|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
10906142|NCT00593333|OG001|Outcome|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
10906143|NCT00593333|EG000|Reported Event|Group A|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
10906144|NCT00593333|EG001|Reported Event|Group B|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
10906145|NCT00593346|BG000|Baseline|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
10906146|NCT00593346|FG000|Participant Flow|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
10906147|NCT00593346|OG000|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
10906148|NCT00593346|OG000|Outcome|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
10906149|NCT00593346|EG000|Reported Event|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
10906150|NCT00593372|BG000|Baseline|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
10906151|NCT00593372|BG001|Baseline|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
10906152|NCT00593372|BG002|Baseline|Total|Total of all reporting groups
10906153|NCT00593372|FG000|Participant Flow|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
10906154|NCT00593372|FG001|Participant Flow|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
10906155|NCT00593372|OG000|Outcome|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
10906156|NCT00593372|OG001|Outcome|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
10906157|NCT00593372|EG000|Reported Event|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
10906158|NCT00593372|EG001|Reported Event|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
10906159|NCT00593385|BG000|Baseline|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
10906160|NCT00593385|FG000|Participant Flow|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
10906161|NCT00593385|OG000|Outcome|iCAST Covered Stent|"Device: iCAST covered stent~Implantation of ≥1 iCAST stents"
10906162|NCT00593385|OG000|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
10906163|NCT00593385|OG000|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
10906164|NCT00593385|EG000|Reported Event|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
10906165|NCT00593450|BG000|Baseline|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
10906166|NCT00593450|BG001|Baseline|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
10906167|NCT00593450|BG002|Baseline|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
10906168|NCT00593450|BG003|Baseline|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
10906169|NCT00593450|BG004|Baseline|Total|Total of all reporting groups
10906170|NCT00593450|FG000|Participant Flow|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
10906171|NCT00593450|FG001|Participant Flow|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
10906172|NCT00593450|FG002|Participant Flow|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
10906173|NCT00593450|FG003|Participant Flow|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
10906174|NCT00593450|OG000|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
10906175|NCT00593450|OG001|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
10906176|NCT00593450|OG002|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
10906177|NCT00593450|OG003|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
10906178|NCT00593450|EG000|Reported Event|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
10906179|NCT00593450|EG001|Reported Event|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
10906180|NCT00593450|EG002|Reported Event|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
10906181|NCT00593450|EG003|Reported Event|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
10906182|NCT00593489|BG000|Baseline|Basal Insulin Strategy|"Basal Insulin Strategy~Support by community pharmacist~Support by diabetes specialist"
10906183|NCT00593489|BG001|Baseline|Usual Care|usual care - no intervention
10906184|NCT00593489|BG002|Baseline|Total|Total of all reporting groups
10906185|NCT00593489|FG000|Participant Flow|Basal Insulin Strategy|"Basal Insulin Strategy~Support by community pharmacist~Support by diabetes specialist"
10906186|NCT00593489|FG001|Participant Flow|Usual Care|usual care - no intervention
10906187|NCT00593489|OG000|Outcome|Basal Insulin Strategy|"Basal Insulin Strategy~Support by community pharmacist~Support by diabetes specialist"
10906188|NCT00593489|OG001|Outcome|Usual Care|usual care - no intervention
10906189|NCT00593489|OG000|Outcome|Basal Insulin Initiation Strategy|"Basal Insulin Initiation Strategy which includes:~support by community pharmacist~support by diabetes specialist~Basal Insulin Initiation Strategy: This multifaceted intervention consists of (1) Diabetes Specialist Consultation Support which entails specialists and educators providing consultation for insulin initiation and titration for the 12 months following the Workshop. Support will consist of prearranged and scheduled communications to review and advise for the first 2 months and will continue on an ad hoc basis for the remaining 10 months, with communication initiated by the physician (2)Community Pharmacy Insulin Initiation consists of trained community pharmacists providing patient education insulin initiation. Education will consist of one individual teaching session, one hour in duration, to review the insulin prescription protocol, insulin injection method, management of hypoglycemia, and self-monitoring of blood glucose."
10906190|NCT00593489|OG001|Outcome|Usual Practice|The physicians randomized to this group proceeded with their usual practice
10906191|NCT00593489|EG000|Reported Event|Basal Insulin Strategy|"Basal Insulin Strategy~Support by community pharmacist~Support by diabetes specialist"
10906192|NCT00593489|EG001|Reported Event|Usual Care|usual care used as the control
10906193|NCT00593554|BG000|Baseline|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
10906194|NCT00593554|BG001|Baseline|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
10906195|NCT00593554|BG002|Baseline|Total|Total of all reporting groups
10906196|NCT00593554|FG000|Participant Flow|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
10906197|NCT00593554|FG001|Participant Flow|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
10906198|NCT00593554|OG000|Outcome|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
10906199|NCT00593554|OG001|Outcome|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
10906200|NCT00593554|EG000|Reported Event|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
10906201|NCT00593554|EG001|Reported Event|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
10906202|NCT00593606|BG000|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
10906203|NCT00593606|FG000|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
10906204|NCT00593606|OG000|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
10906205|NCT00593606|EG000|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
10906206|NCT00593645|BG000|Baseline|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
10906207|NCT00593645|FG000|Participant Flow|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
10906208|NCT00593645|OG000|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
10906209|NCT00593645|EG000|Reported Event|Arm 1|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
10906210|NCT00593684|BG000|Baseline|Algidex Patch|
10906211|NCT00593684|BG001|Baseline|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
10906212|NCT00593684|BG002|Baseline|Total|Total of all reporting groups
10906213|NCT00593684|FG000|Participant Flow|Algidex Patch|
10906214|NCT00593684|FG001|Participant Flow|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
10906215|NCT00593684|OG000|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
10906216|NCT00593684|OG001|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
10906217|NCT00593684|EG000|Reported Event|Algidex Patch|
10906218|NCT00593684|EG001|Reported Event|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
10906219|NCT00593736|BG000|Baseline|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
10906220|NCT00593736|BG001|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
10906221|NCT00593736|BG002|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
10906222|NCT00593736|BG003|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
10906223|NCT00593736|BG004|Baseline|Total|Total of all reporting groups
10906224|NCT00593736|FG000|Participant Flow|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
10906225|NCT00593736|FG001|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
10906226|NCT00593736|FG002|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
10906227|NCT00593736|FG003|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
10906228|NCT00593736|OG000|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
10906229|NCT00593736|OG001|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
10906230|NCT00593736|OG002|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
10906231|NCT00593736|OG003|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
10906232|NCT00593736|EG000|Reported Event|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
10906233|NCT00593736|EG001|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
10906234|NCT00593736|EG002|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
10906235|NCT00593736|EG003|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
10906236|NCT00593814|BG000|Baseline|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
10906237|NCT00593814|BG001|Baseline|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
10906238|NCT00593814|BG002|Baseline|Total|Total of all reporting groups
10906239|NCT00593814|FG000|Participant Flow|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
10906240|NCT00593814|FG001|Participant Flow|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
10906241|NCT00593814|OG000|Outcome|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
10906242|NCT00593814|OG001|Outcome|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
10906243|NCT00593814|EG000|Reported Event|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
10906244|NCT00593814|EG001|Reported Event|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
10906245|NCT00593827|BG000|Baseline|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
10906246|NCT00593827|BG001|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
10906247|NCT00593827|BG002|Baseline|Total|Total of all reporting groups
10906248|NCT00593827|FG000|Participant Flow|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
10906249|NCT00593827|FG001|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
10906250|NCT00593827|OG000|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
10906251|NCT00593827|OG001|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
10906252|NCT00593827|EG000|Reported Event|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
10906253|NCT00593827|EG001|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
11091108|NCT01533038|BG001|Baseline|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
10906258|NCT00593866|BG000|Baseline|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
10906259|NCT00593866|FG000|Participant Flow|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
10906260|NCT00593866|OG000|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
11091109|NCT01533038|BG002|Baseline|Total|Total of all reporting groups
11172461|NCT02009722|EG000|Reported Event|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
11172462|NCT02009722|EG001|Reported Event|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
11172463|NCT02009865|BG000|Baseline|Epanova|2g once daily (QD)
11172464|NCT02009865|BG001|Baseline|Olive Oil|2g once daily (QD)
11172465|NCT02009865|BG002|Baseline|Total|Total of all reporting groups
11172466|NCT02009865|FG000|Participant Flow|Epanova|2g once daily (QD)
11172467|NCT02009865|FG001|Participant Flow|Olive Oil|2g once daily (QD)
11172468|NCT02009865|OG000|Outcome|Epanova|2g once daily (QD)
11172469|NCT02009865|OG001|Outcome|Olive Oil|2g once daily (QD)
11172470|NCT02009865|EG000|Reported Event|Epanova|2g once daily (QD)
11342114|NCT03697122|EG000|Reported Event|HHBC and Forced Air Warming|"Patients admitted to intensive care unit hypothermic (≤ 35 C) following surgical procedures involving cardiopulmonary bypass. Will be rewarmed with heated humidified breathing circuits (ANAPOD) and standard forced air warming blankets.~Heated Humidified Breathing Circuit and Forced Air Blanket: Heated humidified breathing circuits (ANAPOD) will be set up and managed by respiratory therapist in standard fashion defined by the manufacturer. Temperate will be set at 41C.~Forced air warming blankets will be set at 42C for duration of rewarming."
10906261|NCT00593866|EG000|Reported Event|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
10906262|NCT00593918|BG000|Baseline|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
10906263|NCT00593918|BG001|Baseline|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
10906264|NCT00593918|BG002|Baseline|Total|Total of all reporting groups
10906265|NCT00593918|FG000|Participant Flow|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
10906266|NCT00593918|FG001|Participant Flow|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
10906267|NCT00593918|OG000|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
10906268|NCT00593918|OG001|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
10906269|NCT00593918|EG000|Reported Event|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
10906270|NCT00593918|EG001|Reported Event|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
10906271|NCT00593957|BG000|Baseline|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906272|NCT00593957|BG001|Baseline|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906273|NCT00593957|BG002|Baseline|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906274|NCT00593957|BG003|Baseline|Total|Total of all reporting groups
10906275|NCT00593957|FG000|Participant Flow|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906276|NCT00593957|FG001|Participant Flow|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906277|NCT00593957|FG002|Participant Flow|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906278|NCT00593957|OG000|Outcome|Dextromethorphan (DM)1 EEG Spike Counts at Baseline|Dextromethorphan(DM)I group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at baseline.
10906279|NCT00593957|OG001|Outcome|DM2 EEG Spike Counts at Baseline|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at baseline.
10906280|NCT00593957|OG002|Outcome|DM3 EEG Spike Counts at Baseline|"DM3 group received Dextromethorphan 5mg/kg/day.~The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at baseline."
10906281|NCT00593957|OG003|Outcome|DM1 EEG Spike Count at 6 Months|DM1 group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at 6 months.
10906282|NCT00593957|OG004|Outcome|DM2 EEG Spike Counts at 6 Months|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at 6 months.
10906283|NCT00593957|OG005|Outcome|DM3 EEG Spike Counts at 6 Months|DM3 group received Dextromethorphan 5mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at 6 months.
10906284|NCT00593957|OG000|Outcome|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906285|NCT00593957|OG001|Outcome|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906286|NCT00593957|OG002|Outcome|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906287|NCT00593957|OG000|Outcome|DM1( 0.25 mg/kg /Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 0.25 mg/kg per day treatment arm.
10906288|NCT00593957|OG001|Outcome|DM2 (2.5 mg/kg/Day)SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 2.5 mg/kg/day treatment arm.
10906289|NCT00593957|OG002|Outcome|DM3 (5mg/kg/Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 5mg/kg/day treatment arm.
10906290|NCT00593957|OG003|Outcome|DM1( 0.25 mg/kg /Day) SSI 6 Months|DM1( 0.25 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
10906291|NCT00593957|OG004|Outcome|DM2 (2.5 mg/kg/Day) SSI 6 Months|DM2( 2.5 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
10906292|NCT00593957|OG005|Outcome|DM3 (5.0 mg/kg/Day) SSI 6 Months|DM3(5.0) mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
10906293|NCT00593957|OG000|Outcome|Total Sample SSI Mean Score at Baseline|Study Sample Screen for Social Interaction (SSI) mean core at baseline.
10906294|NCT00593957|OG001|Outcome|Total Sample SSI Mean Score at 6 Months|Study Sample Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
10906295|NCT00593957|EG000|Reported Event|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906296|NCT00593957|EG001|Reported Event|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906297|NCT00593957|EG002|Reported Event|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
10906298|NCT00594009|BG000|Baseline|VVCO2R in COPD|"All patients enrolled in the trial will receive the proposed intervention~Rotaflow centrifugal pump (Maquet, Inc.): Patients who meet criteria will be placed on an extracorporeal device for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care"
10906299|NCT00594009|FG000|Participant Flow|Venovenous CO2 Removal (VVCO2R) in COPD|All patients enrolled in the trial will receive the proposed Patients who meet criteria will be placed on an extracorporeal device for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care
10906300|NCT00594009|OG000|Outcome|VVCO2R in COPD|"All patients enrolled in the trial will receive the proposed intervention~Patients who meet criteria will be placed on an extracorporeal device for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care"
11172471|NCT02009865|EG001|Reported Event|Olive Oil|2g once daily (QD)
10906301|NCT00594009|EG000|Reported Event|VVCO2R in COPD|"All patients enrolled in the trial will receive the proposed intervention~Rotaflow centrifugal pump (Maquet, Inc.): Patients who meet criteria will be placed on an extracorporeal device for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care"
10906302|NCT00594022|BG000|Baseline|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
10906303|NCT00594022|BG001|Baseline|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
10906304|NCT00594022|BG002|Baseline|Total|Total of all reporting groups
10906305|NCT00594022|FG000|Participant Flow|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
10906306|NCT00594022|FG001|Participant Flow|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
10906307|NCT00594022|OG000|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
10906308|NCT00594022|OG001|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
10906309|NCT00594022|EG000|Reported Event|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
10906310|NCT00594022|EG001|Reported Event|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
10906311|NCT00594035|BG000|Baseline|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
10906312|NCT00594035|BG001|Baseline|Standard of Care|Subjects who receive standard or care meathods of dural sealing
10906313|NCT00594035|BG002|Baseline|Total|Total of all reporting groups
10906314|NCT00594035|FG000|Participant Flow|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
10906315|NCT00594035|FG001|Participant Flow|Standard of Care|Subjects who receive standard or care meathods of dural sealing
10906316|NCT00594035|OG000|Outcome|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
10906317|NCT00594035|OG001|Outcome|Standard of Care|Subjects who receive standard or care meathods of dural sealing
10906318|NCT00594035|EG000|Reported Event|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
10906319|NCT00594035|EG001|Reported Event|Standard of Care|Subjects who receive standard or care meathods of dural sealing
10906320|NCT00594061|BG000|Baseline|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves ashis or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
10906321|NCT00594061|FG000|Participant Flow|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves as his or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
10906322|NCT00594061|OG000|Outcome|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves as his or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
10906323|NCT00594061|EG000|Reported Event|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves ashis or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
10906324|NCT00594100|BG000|Baseline|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
10906325|NCT00594100|FG000|Participant Flow|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
10906326|NCT00594100|OG000|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
10906327|NCT00594100|EG000|Reported Event|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
10906328|NCT00594165|BG000|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10906329|NCT00594165|FG000|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
11172472|NCT02009878|BG000|Baseline|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
11172473|NCT02009878|BG001|Baseline|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
11172474|NCT02009878|BG002|Baseline|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
11172475|NCT02009878|BG003|Baseline|Total|Total of all reporting groups
11172476|NCT02009878|FG000|Participant Flow|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
11172477|NCT02009878|FG001|Participant Flow|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
11172478|NCT02009878|FG002|Participant Flow|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
11172479|NCT02009878|OG000|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
11172480|NCT02009878|OG001|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
11172481|NCT02009878|OG002|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
11172482|NCT02009878|EG000|Reported Event|Tolvaptan 3.75 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
11172483|NCT02009878|EG001|Reported Event|Tolvaptan 7.5 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
11172484|NCT02009878|EG002|Reported Event|Tolvaptan 15 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
11172485|NCT02009930|BG000|Baseline|Coronary Artery Calcium (CAC) / Framingham Risk Score (FRS)|Coronary Artery Calcium (CAC) scores are reported as a numerical value and a percentage for age that is then regarded in terms of risk categories. The Framingham Risk Score (FRS) is a standard of care for estimating risk of a cardiovascular event over the next 10 years
11172486|NCT02009930|FG000|Participant Flow|Coronary Artery Calcium (CAC) / Framingham Risk Score (FRS)|Coronary Artery Calcium (CAC) scores are reported as a numerical value and a percentage for age that is then regarded in terms of risk categories. The Framingham Risk Score (FRS) is a standard of care for estimating risk of a cardiovascular event over the next 10 years
11172487|NCT02009930|OG000|Outcome|Coronary Artery Calcium (CAC)|Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
11172488|NCT02009930|OG000|Outcome|Coronary Artery Calcification (CAC)|Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
11172489|NCT02009930|OG000|Outcome|FRS Risk Category|Compare FRS risk categories (low, moderate, moderate -high, high, and very high) between groups
11172490|NCT02009930|OG001|Outcome|CAC Risk Category|Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
11172491|NCT02009930|OG000|Outcome|FRS Risk Category|Compare FRS risk categories (low, moderate, moderate -high, high, and very high) among groups
11172492|NCT02009930|OG001|Outcome|CAC Risk Category|Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) among groups
11172493|NCT02009930|OG000|Outcome|Coronary Artery Calcification (CAC)|Compare CAC risk categories (low, low-mod, mod-high, high and very high) between groups
11172494|NCT02009930|OG000|Outcome|Coronary Artery Calcification (CAC)|Compare CAC risk categories (low, low-mod, mod-high, high and very high) among groups
11172495|NCT02009930|EG000|Reported Event|Compare CAC and FRS|Coronary Artery Calcium (CAC) scores are reported as a numerical value and a percentage for age that is then regarded in terms of risk categories. The Framingham Risk Score (FRS) is a standard of care for estimating risk of a cardiovascular event over the next 10 years
10906330|NCT00594165|OG000|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10906331|NCT00594165|EG000|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10906332|NCT00594178|BG000|Baseline|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
10906333|NCT00594178|FG000|Participant Flow|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
10906334|NCT00594178|OG000|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
10906335|NCT00594178|EG000|Reported Event|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
10906336|NCT00594204|BG000|Baseline|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
10906337|NCT00594204|BG001|Baseline|Placebo|matching placebo following the same treatment schema as the varenicline group
10906338|NCT00594204|BG002|Baseline|Total|Total of all reporting groups
10906339|NCT00594204|FG000|Participant Flow|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
10906340|NCT00594204|FG001|Participant Flow|Placebo|matching placebo following the same treatment schema as the varenicline group
10906341|NCT00594204|OG000|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
11172496|NCT02010021|BG000|Baseline|No Drug Treatment|Post-menopausal women with stage I-III breast cancer with surgical resection of tumor and tumor tissue will be used to study cell growth signaling pathways ex-vivo.
10906342|NCT00594204|OG001|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
10906343|NCT00594204|EG000|Reported Event|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
10906344|NCT00594204|EG001|Reported Event|Placebo|matching placebo following the same treatment schema as the varenicline group
11172497|NCT02010021|BG001|Baseline|Letrozole-presurgical|Patients received Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue was used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.
11172498|NCT02010021|BG002|Baseline|Total|Total of all reporting groups
10906345|NCT00594230|BG000|Baseline|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
11172499|NCT02010021|FG000|Participant Flow|No Drug Treatment|Post-menopausal women with stage I-III breast cancer with surgical resection of tumor and tumor tissue will be used to study cell growth signaling pathways ex-vivo.
11172500|NCT02010021|FG001|Participant Flow|Letrozole-presurgical|Patients received Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue was used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.
11172501|NCT02010021|OG000|Outcome|No Drug Treatment|Post-menopausal women with stage I-III breast cancer with surgical resection of tumor and tumor tissue will be used to study cell growth signaling pathways ex-vivo.
11172502|NCT02010021|OG001|Outcome|Letrozole-presurgical|Patients received Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue was used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.
11172503|NCT02010021|EG000|Reported Event|No Drug Treatment|Post-menopausal women with stage I-III breast cancer with surgical resection of tumor and tumor tissue will be used to study cell growth signaling pathways ex-vivo.
11172504|NCT02010021|EG001|Reported Event|Letrozole-presurgical|Patients received Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue was used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.
11172505|NCT02010151|BG000|Baseline|Conventional Dispatcher CPR|patients enrolled in period that conventional dispatcher CPR was provided to the patients.
11172506|NCT02010151|BG001|Baseline|NAD-CPR|patients enrolled in period that NAD-CPR was provided to the patients.
11172507|NCT02010151|BG002|Baseline|Total|Total of all reporting groups
11172508|NCT02010151|FG000|Participant Flow|Conventional Dispatcher Assisted CPR|"patients enrolled in period that conventional dispatcher assisted CPR was provided to patient (January 2013 to April 2015).~baseline EMS assessed OHCA: 2,418~Adult~presumed cardiac etiology~Resuscitation attempted~Not witnessed by EMS provider~Eligible for analysis Final population : 1498"
11172509|NCT02010151|FG001|Participant Flow|NAD-CPR|"patients enrolled in period that NAD-CPR was provided to patient (May 2015 to December 2017)~baseline EMS assessed OHCA: 2,611~Adult~presumed cardiac etiology~Resuscitation attempted~Not witnessed by EMS provider~Eligible for analysis Final population : 1,696 (TM sent: 598)"
11172510|NCT02010151|OG000|Outcome|Conventional Dispatcher CPR|patients enrolled in period that conventional dispatcher CPR was provided to the patients.
11172511|NCT02010151|OG001|Outcome|NAD-CPR|patients enrolled in period that NAD-CPR was provided to the patients.
11172512|NCT02010151|EG000|Reported Event|Conventional Dispatcher CPR|patients enrolled in period that conventional dispatcher CPR was provided to the patients.
11172513|NCT02010151|EG001|Reported Event|NAD-CPR|patients enrolled in period that NAD-CPR was provided to the patients.
11172514|NCT02010203|BG000|Baseline|Phase I: HS-410 Low Dose|"In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96"
11172515|NCT02010203|BG001|Baseline|Phase II: HS-410 Low-Dose Plus BCG|"In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96~BCG: Vaccine derived from a live bacterium"
11172516|NCT02010203|BG002|Baseline|Phase II: High-Dose HS-410 Plus BCG|"In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96~BCG: Vaccine derived from a live bacterium"
10906346|NCT00594230|BG001|Baseline|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10906347|NCT00594230|BG002|Baseline|Total|Total of all reporting groups
10906348|NCT00594230|FG000|Participant Flow|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10906349|NCT00594230|FG001|Participant Flow|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10906350|NCT00594230|OG000|Outcome|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10906351|NCT00594230|OG001|Outcome|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10906352|NCT00594230|EG000|Reported Event|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10906353|NCT00594230|EG001|Reported Event|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
10906354|NCT00594256|BG000|Baseline|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
10906355|NCT00594256|FG000|Participant Flow|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
10906356|NCT00594256|OG000|Outcome|Sodium Oxybate|
10906357|NCT00594256|OG000|Outcome|Sodiumn Oxybate|
10906358|NCT00594256|EG000|Reported Event|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
10906359|NCT00594308|BG000|Baseline|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
10906360|NCT00594308|FG000|Participant Flow|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
10906361|NCT00594308|OG000|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
10906362|NCT00594308|EG000|Reported Event|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
10906363|NCT00594399|BG000|Baseline|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
10906364|NCT00594399|BG001|Baseline|Arm 2|Usual care from primary, womens or geriatric clinics
10906365|NCT00594399|BG002|Baseline|Total|Total of all reporting groups
11172517|NCT02010203|BG003|Baseline|Phase II: Placebo Plus BCG|"In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.~Placebo: Injection containing sterile solution but no cells~BCG: Vaccine derived from a live bacterium"
10906366|NCT00594399|FG000|Participant Flow|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
10906367|NCT00594399|FG001|Participant Flow|Arm 2, Usual Care|Usual care from primary, womens or geriatric clinics
10906368|NCT00594399|FG002|Participant Flow|Arm 3, Physical Activity Counseling, Reduced Dose|Upon rerandomization, individuals in this group continued to receive monthly physical activity counseling through 6 months which was then reduced to every other month during months 6-12.
10906369|NCT00594399|OG000|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
11233414|NCT02427646|FG001|Participant Flow|Parkinson Disease Tremor Treatment|IncobotulinumtoxinA: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
11233415|NCT02427646|OG000|Outcome|Essential Tremor Treatment|IncobotulinumtoxinA: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm. There is reduction in the total number of participants at week 96 compared to week 0 due to lost to follow-up (change in medication and other symptoms arose (n=5), and discontinued from intervention (n=3)).
11233416|NCT02427646|OG001|Outcome|Parkinson Disease Tremor Treatment|IncobotulinumtoxinA: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm. There is reduction in the total number of participants at week 96 compared to week 0 due to lost to follow-up (change in medication and other symptoms arose (n=8), and discontinued from intervention (n=6)).
11233417|NCT02427646|OG000|Outcome|ET BoNT-A Treatment|ET participants treated with kinematic-guided BoNT-A injections over 6 injection cycles. We report change in tremor severity using kinematics from week 0 to week 96.
11233418|NCT02427646|OG001|Outcome|PD Tremor BoNT-A Treatment|PD participants treated with kinematic-guided BoNT-A injections over 6 injection cycles. We report change in tremor severity using kinematics from week 0 to week 96.
11233419|NCT02427646|EG000|Reported Event|Essential Tremor Treatment|IncobotulinumtoxinA: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
10906370|NCT00594399|OG001|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
10906371|NCT00594399|EG000|Reported Event|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
10906372|NCT00594399|EG001|Reported Event|Arm 2|Usual care from primary, womens or geriatric clinics
11172518|NCT02010203|BG004|Baseline|Phase II: High-Dose HS-410|"In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96"
10906373|NCT00594425|BG000|Baseline|40 mg/g MAL PDT|
10906374|NCT00594425|BG001|Baseline|80 mg/g MAL PDT|
10906375|NCT00594425|BG002|Baseline|Vehicle PDT|
10906376|NCT00594425|BG003|Baseline|Total|Total of all reporting groups
10906377|NCT00594425|FG000|Participant Flow|40 mg/g MAL PDT|
10906378|NCT00594425|FG001|Participant Flow|80 mg/g MAL PDT|
10906379|NCT00594425|FG002|Participant Flow|Vehicle PDT|
11172519|NCT02010203|BG005|Baseline|Total|Total of all reporting groups
11172520|NCT02010203|FG000|Participant Flow|Phase I: HS-410 Low Dose|"In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96"
11172521|NCT02010203|FG001|Participant Flow|Phase II: HS-410 Low-Dose Plus BCG|"In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96~BCG: Vaccine derived from a live bacterium"
11342161|NCT03699124|FG001|Participant Flow|GP 2: Two Doses of FD MVA-BN--Lot 2|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
10906380|NCT00594425|OG000|Outcome|40 mg/g MAL PDT|
10906381|NCT00594425|OG001|Outcome|80 mg/g MAL PDT|
10906382|NCT00594425|OG002|Outcome|Vehicle PDT|
10906383|NCT00594425|EG000|Reported Event|40 mg/g MAL PDT|
10906384|NCT00594425|EG001|Reported Event|80 mg/g MAL PDT|
10906385|NCT00594425|EG002|Reported Event|Vehicle PDT|
10906386|NCT00594464|BG000|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
10906387|NCT00594464|FG000|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
10906388|NCT00594464|OG000|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
10906389|NCT00594464|OG000|Outcome|Rotigotine 2 mg/24h|
10906390|NCT00594464|OG001|Outcome|Rotigotine 6mg/24h|
10906391|NCT00594464|OG002|Outcome|Rotigotine 8 mg/24h|
10906392|NCT00594464|OG003|Outcome|Rotigotine 12 mg/24h|
10906393|NCT00594464|OG004|Outcome|Rotigotine 14 mg/24h|
10906394|NCT00594464|OG005|Outcome|Rotigotine 16 mg/24h|
10906395|NCT00594464|EG000|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
10906396|NCT00594516|BG000|Baseline|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
10906397|NCT00594516|FG000|Participant Flow|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
10906398|NCT00594516|FG001|Participant Flow|Tapentadol IR to ER|Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase
10906399|NCT00594516|FG002|Participant Flow|Tapentadol ER to IR|Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
10906400|NCT00594516|OG000|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
10906401|NCT00594516|EG000|Reported Event|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) open-label and the double-blind crossover period.
10906402|NCT00594568|BG000|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
10906403|NCT00594568|BG001|Baseline|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
10906404|NCT00594568|BG002|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10906405|NCT00594568|BG003|Baseline|Total|Total of all reporting groups
10906406|NCT00594568|FG000|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
10906407|NCT00594568|FG001|Participant Flow|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
10906408|NCT00594568|FG002|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10906409|NCT00594568|OG000|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
10906410|NCT00594568|OG001|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
10906411|NCT00594568|OG002|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10906412|NCT00594568|OG000|Outcome|LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10906413|NCT00594568|OG000|Outcome|LY450139|Participants received 60 milligram LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10906414|NCT00594568|EG000|Reported Event|Placebo - Initial Treatment Period (NT)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
10906415|NCT00594568|EG001|Reported Event|100 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
10906416|NCT00594568|EG002|Reported Event|140 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10906417|NCT00594568|EG003|Reported Event|Placebo - Delayed Start Period (DO)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
10906418|NCT00594568|EG004|Reported Event|100 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
10906419|NCT00594568|EG005|Reported Event|140 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10906420|NCT00594568|EG006|Reported Event|Placebo- Safety FU Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
10906421|NCT00594568|EG007|Reported Event|100 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.
10906422|NCT00594568|EG008|Reported Event|140 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
10906423|NCT00594646|BG000|Baseline|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
10906424|NCT00594646|FG000|Participant Flow|Group 1|Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.
10906425|NCT00594646|OG000|Outcome|Group 1|TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily
10906426|NCT00594646|OG000|Outcome|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
10906427|NCT00594646|EG000|Reported Event|Group 1|TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily
10906428|NCT00594659|BG000|Baseline|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Nine weekly therapy sessions delivered in weeks 1-8 and week 12~2 times per week urine drug testing~Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
10906429|NCT00594659|BG001|Baseline|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computer delivered nine MET/CBT sessions during weeks 1-8 and week 12. therapist delivered 3 brief supportive counseling sessions during weeks 1, 4, and 12.~2 times per week urine drug testing.~Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
10906430|NCT00594659|BG002|Baseline|3-tMET|"Therapist delivered motivational enhancement therapy (tMET)~Two session treatment with sessions delivered during weeks 1 and 4.~Two times per week urine drug testing.~Non-contingent incentives delivered for attending each urine testing appointment."
10906431|NCT00594659|BG003|Baseline|Total|Total of all reporting groups
10906432|NCT00594659|FG000|Participant Flow|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Psychotherapy : Nine session treatment (wks 1-8 and wk 12)~2x/wk urine drug testing~Contingency Management voucher program"
10906433|NCT00594659|FG001|Participant Flow|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computerized Psychotherapy : Nine session computer delivered treatment~2 times per week urine drug testing"
10906434|NCT00594659|FG002|Participant Flow|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment~2x/wk urine drug testing~non-contingent vouchers"
10906435|NCT00594659|OG000|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment~Psychotherapy : Nine session treatment"
10906436|NCT00594659|OG001|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment~Computerized Psychotherapy : Nine session computer delivered treatment"
10906437|NCT00594659|OG002|Outcome|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment"
10906438|NCT00594659|EG000|Reported Event|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Psychotherapy : Nine session treatment (wks 1-8 and wk 12)~2x/wk urine drug testing~Contingency Management voucher program"
10906439|NCT00594659|EG001|Reported Event|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computerized Psychotherapy : Nine session computer delivered treatment~2 times per week urine drug testing"
10906440|NCT00594659|EG002|Reported Event|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment~2x/wk urine drug testing~non-contingent vouchers"
10906441|NCT00594685|BG000|Baseline|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
10906442|NCT00594685|FG000|Participant Flow|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
10906443|NCT00594685|OG000|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
10906444|NCT00594685|EG000|Reported Event|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
10906445|NCT00594815|BG000|Baseline|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
10906446|NCT00594815|FG000|Participant Flow|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
10906447|NCT00594815|OG000|Outcome|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
10906448|NCT00594815|EG000|Reported Event|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|This is a single-armed pilot study designed to evaluate the safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for participants with newly diagnosed PCNSL.
10906449|NCT00594854|BG000|Baseline|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
10906450|NCT00594854|BG001|Baseline|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
10906451|NCT00594854|BG002|Baseline|Total|Total of all reporting groups
10906452|NCT00594854|FG000|Participant Flow|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
10906453|NCT00594854|FG001|Participant Flow|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
10906454|NCT00594854|OG000|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
10906455|NCT00594854|OG001|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
10906456|NCT00594854|EG000|Reported Event|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
10906457|NCT00594854|EG001|Reported Event|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
10906458|NCT00594880|BG000|Baseline|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
10906459|NCT00594880|BG001|Baseline|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
10906460|NCT00594880|BG002|Baseline|Total|Total of all reporting groups
10906461|NCT00594880|FG000|Participant Flow|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
10906462|NCT00594880|FG001|Participant Flow|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
10906463|NCT00594880|OG000|Outcome|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
10906464|NCT00594880|OG001|Outcome|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
10906465|NCT00594880|OG000|Outcome|180 mcg/Week|Patients receiving 180 micrograms/week of pegylated interferon alpha-2a
10906466|NCT00594880|OG001|Outcome|90 mcg/Week|Patients receiving 90 micrograms/week of pegylated interferon alpha-2a
10906467|NCT00594880|OG000|Outcome|180 mcg/Week|Arm 1 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
10906468|NCT00594880|OG001|Outcome|90 mcg/Week|Arm 2 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
10906469|NCT00594880|EG000|Reported Event|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
10906470|NCT00594880|EG001|Reported Event|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
10906471|NCT00594906|BG000|Baseline|Injection|"30 participants will receive teriparatide (Forteo) injection pens.~Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
10906472|NCT00594906|BG001|Baseline|Placebo|"30 participants will receive placebo injection pens.~Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
10906473|NCT00594906|BG002|Baseline|Total|Total of all reporting groups
10906474|NCT00594906|FG000|Participant Flow|Forteo Injection|"30 participants will receive teriparatide (Forteo) injection pens.~Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
10906475|NCT00594906|FG001|Participant Flow|Placebo Injection|"30 participants will receive placebo injection pens.~Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
10906476|NCT00594906|OG000|Outcome|Placebo Patients|Patients who recieved Placebo injections.
10906477|NCT00594906|OG001|Outcome|Forteo Patients|Patients who recieved Forteo Injections.
10906478|NCT00594906|EG000|Reported Event|Forteo Injection|Patients who randomized to the study drug, Forteo
10906479|NCT00594906|EG001|Reported Event|Placebo Injection|Patients who were randomized to Placebo
10906480|NCT00594932|BG000|Baseline|Patients Who Received MMF for the First 3 Months|13 patients were randomized to receive MMF for the first 3 months. MMF was (blindly) increased to maximal tolerated dose or 3 gms/daily whichever was lowest.
10906481|NCT00594932|BG001|Baseline|Patients Who Received Placebo for the First 3 Months|14 patients were randomized to placebo for the first three months
10906482|NCT00594932|BG002|Baseline|Total|Total of all reporting groups
10906483|NCT00594932|FG000|Participant Flow|Patients Who Received MMF for the First 3 Months|13 patients were randomized to receive MMF for the first 3 months. MMF was (blindly) increased to maximal tolerated dose or 3 gms/daily whichever was lowest.
10906484|NCT00594932|FG001|Participant Flow|Patients Who Received Placebo for the First 3 Months|14 patients were randomized to placebo for the first three months
10906485|NCT00594932|OG000|Outcome|Patients Who Received MMF for the First 3 Months|13 patients were randomized to receive MMF for the first 3 months. MMF was (blindly) increased to maximal tolerated dose or 3 gms/daily whichever was lowest.
10906486|NCT00594932|OG001|Outcome|Patients Who Received Placebo for the First 3 Months|14 patients were randomized to placebo for the first three months
10906487|NCT00594932|EG000|Reported Event|Mycophenolate Mofetil|"Patients receiving mycophenolate mofetil from baseline throughout their participation in the study (up to six months). Mycophenolate is a standard of care treatment for SLE, and the primary endpoint was at three months, after which mycophenolate was given open lable. This trial did not collect adverse events after three months in any formal manner that can be reported here.~However there were no deaths so we can report that for six months. We can also report serious adverse events for all six months. Therefore deaths and serious adverse events are reported for six months and placebo crossovers are included in the at risk population for a total of 24 at risk. However non serious adverse events can only be reported for three months so the population at risk remains at 13 for non serious adverse events."
10906488|NCT00594932|EG001|Reported Event|Placebo|Patients receiving placebo for the first three months. They were then offered mycophenolate mofetil for up to three more months. Since this is a standard of care for SLE formal assessment of adverse events was not performed during the second three months. We cannot provide any data after the first three months on placebo patients since there were no placebo patients after the first three months. Therefore the at risk population on placebo is 14 and the reporting period is 3 months for them. This is true for all types of adverse events since there was no placebo group after 3 months.
10906489|NCT00594945|BG000|Baseline|Intranasal Clonazepam 2 mg|
10906490|NCT00594945|BG001|Baseline|Intranasal Clonazepam 3 mg|
10906491|NCT00594945|BG002|Baseline|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|
10906492|NCT00594945|BG003|Baseline|Total|Total of all reporting groups
10906493|NCT00594945|FG000|Participant Flow|Intranasal Clonazepam 2 mg|Treatment administered to subjects during Cohort 1
10906494|NCT00594945|FG001|Participant Flow|Intranasal Clonazepam 3 mg|Treatment administered to subjects during Cohort 2
10906495|NCT00594945|FG002|Participant Flow|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|Subjects who were administered 2 mg during Cohort 1 and then 3 mg during Cohort 2
10906496|NCT00594945|OG000|Outcome|Intranasal Clonazepam 2 mg|
10906497|NCT00594945|OG001|Outcome|Intranasal Clonazepam 3 mg|
10906498|NCT00594945|EG000|Reported Event|Intranasal Clonazepam 2 mg|
10906499|NCT00594945|EG001|Reported Event|Intranasal Clonazepam 3 mg|
10906500|NCT00594958|BG000|Baseline|IC51 Group A|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906501|NCT00594958|BG001|Baseline|IC51 Group B|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906502|NCT00594958|BG002|Baseline|IC51 Group C|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906503|NCT00594958|BG003|Baseline|Total|Total of all reporting groups
10906504|NCT00594958|FG000|Participant Flow|IC51 Group A|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906505|NCT00594958|FG001|Participant Flow|IC51 Group B|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906506|NCT00594958|FG002|Participant Flow|IC51 Group C|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906507|NCT00594958|OG000|Outcome|IC51 Group A|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906508|NCT00594958|OG001|Outcome|IC51 Group B|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906509|NCT00594958|OG002|Outcome|IC51 Group C|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906510|NCT00594958|EG000|Reported Event|IC51 Group A|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906511|NCT00594958|EG001|Reported Event|IC51 Group B|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906512|NCT00594958|EG002|Reported Event|IC51 Group C|IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
10906513|NCT00594997|BG000|Baseline|Education|"Students who receive an educational intervention which consists of a 45 minute interactive presentation as well as a 30 minute health education entertainment by a juggler.~Education: Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer"
10906514|NCT00594997|BG001|Baseline|Control|"Students who fill out pre and post surveys and receive the intervention after the post-survey~Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls."
10906515|NCT00594997|BG002|Baseline|Total|Total of all reporting groups
10906516|NCT00594997|FG000|Participant Flow|Education|"Students who receive an educational intervention which consists of a 45 minute interactive presentation as well as a 30 minute health education entertainment by a juggler.~Education: Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer"
10906517|NCT00594997|FG001|Participant Flow|Control|"Students who fill out pre and post surveys and receive the intervention after the post-survey~Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls."
10906518|NCT00594997|OG000|Outcome|Education|Number of reported incident cases of Lyme by parents of children who received a 45 minute educational intervention by a health educator.
10906519|NCT00594997|OG001|Outcome|Control|The number of incident cases of Lyme reported by parents of students in the control group. These students did not receive the educational intervention.
10906520|NCT00594997|OG000|Outcome|Education|"Students who receive an educational intervention which consists of a 45 minute interactive presentation as well as a 30 minute health education entertainment by a juggler.~Education: Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer"
10906521|NCT00594997|OG001|Outcome|Control|"Students who fill out pre and post surveys and receive the intervention after the post-survey~Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls."
11342162|NCT03699124|FG002|Participant Flow|GP 3: Two Doses of FD MVA-BN--Lot 3|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
10906522|NCT00594997|EG000|Reported Event|Education|"Students who receive an educational intervention which consists of a 45 minute interactive presentation as well as a 30 minute health education entertainment by a juggler.~Education: Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer"
10906523|NCT00594997|EG001|Reported Event|Control|"Students who fill out pre and post surveys and receive the intervention after the post-survey~Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls."
10906524|NCT00595075|BG000|Baseline|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
10906525|NCT00595075|BG001|Baseline|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
10906526|NCT00595075|BG002|Baseline|Total|Total of all reporting groups
10906527|NCT00595075|FG000|Participant Flow|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
10906528|NCT00595075|FG001|Participant Flow|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
10906529|NCT00595075|OG000|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
10906530|NCT00595075|OG001|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
10906531|NCT00595075|EG000|Reported Event|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
10906532|NCT00595075|EG001|Reported Event|Placebo|Placebo will be given prior to a 2-hour nap
10906533|NCT00595088|BG000|Baseline|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
10906534|NCT00595088|FG000|Participant Flow|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
10906535|NCT00595088|OG000|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
10906536|NCT00595088|EG000|Reported Event|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
10906537|NCT00595101|BG000|Baseline|PF-0318 0.006%|PF-0318 0.006% once daily in the evening
10906538|NCT00595101|BG001|Baseline|PF-0318 0.024%|PF-0318 0.024% once daily in the evening
10906539|NCT00595101|BG002|Baseline|PF-0318 0.04%|PF-0318 0.04% once daily in the evening
10906540|NCT00595101|BG003|Baseline|0.005% Latanoprost|0.005% latanoprost once daily in the evening
10906541|NCT00595101|BG004|Baseline|Total|Total of all reporting groups
10906542|NCT00595101|FG000|Participant Flow|PF-0318 0.006%|PF-0318 0.006% once daily in the evening
10906543|NCT00595101|FG001|Participant Flow|PF-0318 0.024%|PF-0318 0.024% once daily in the evening
10906544|NCT00595101|FG002|Participant Flow|PF-0318 0.04%|PF-0318 0.04% once daily in the evening
10906545|NCT00595101|FG003|Participant Flow|0.005% Latanoprost|0.005% latanoprost once daily in the evening
10906546|NCT00595101|OG000|Outcome|PF-0318 0.006%|PF-0318 0.006% once daily in the evening
10906547|NCT00595101|OG001|Outcome|PF-0318 0.024%|PF-0318 0.024% once daily in the evening
10906548|NCT00595101|OG002|Outcome|PF-0318 0.04%|PF-0318 0.04% once daily in the evening
10906549|NCT00595101|OG003|Outcome|0.005% Latanoprost|0.005% latanoprost once daily in the evening
10906550|NCT00595101|EG000|Reported Event|PF-0318 0.006%|PF-0318 0.006% once daily in the evening
10906551|NCT00595101|EG001|Reported Event|PF-0318 0.024%|PF-0318 0.024% once daily in the evening
10906552|NCT00595101|EG002|Reported Event|PF-0318 0.04%|PF-0318 0.04% once daily in the evening
10906553|NCT00595101|EG003|Reported Event|0.005% Latanoprost|0.005% latanoprost once daily in the evening
10906554|NCT00595114|BG000|Baseline|MIA 1|Participants from the MIA trial with mild asthma
10906555|NCT00595114|BG001|Baseline|KIA 1|Participants from the KIA trial with severe asthma
10906556|NCT00595114|BG002|Baseline|Total|Total of all reporting groups
10906557|NCT00595114|FG000|Participant Flow|MIA 1|Participants from the MIA trial with mild asthma
10906558|NCT00595114|FG001|Participant Flow|KIA 1|Participants from the KIA trial with severe asthma
10906559|NCT00595114|OG000|Outcome|MIA 1|Participants from the MIA trial with mild asthma
10906560|NCT00595114|OG001|Outcome|KIA 1|Participants from the KIA trial with severe asthma
10906561|NCT00595114|EG000|Reported Event|MIA 1|Participants from the MIA trial with mild asthma
10906562|NCT00595114|EG001|Reported Event|KIA 1|Participants from the KIA trial with severe asthma
10906563|NCT00595127|BG000|Baseline|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
10906564|NCT00595127|FG000|Participant Flow|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
10906565|NCT00595127|OG000|Outcome|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
10906566|NCT00595127|EG000|Reported Event|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
10906567|NCT00595153|BG000|Baseline|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
10906568|NCT00595153|BG001|Baseline|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10906569|NCT00595153|BG002|Baseline|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10906570|NCT00595153|BG003|Baseline|Total|Total of all reporting groups
10906571|NCT00595153|FG000|Participant Flow|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
10906572|NCT00595153|FG001|Participant Flow|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10906573|NCT00595153|FG002|Participant Flow|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10906574|NCT00595153|OG000|Outcome|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
10906575|NCT00595153|OG001|Outcome|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10906576|NCT00595153|OG002|Outcome|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10906577|NCT00595153|EG000|Reported Event|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
10906578|NCT00595153|EG001|Reported Event|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10906579|NCT00595153|EG002|Reported Event|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10906580|NCT00595231|BG000|Baseline|Rufinamide|500 mg for 1 week followed by 1000 mg for 7 weeks
10906581|NCT00595231|BG001|Baseline|Placebo|Placebo, 0 mg tablets
10906582|NCT00595231|BG002|Baseline|Total|Total of all reporting groups
10906583|NCT00595231|FG000|Participant Flow|Rufinamide|500 mg 1 week, followed by 1000 mg for 7 weeks
10906584|NCT00595231|FG001|Participant Flow|Placebo|0 mg. tablet
10906585|NCT00595231|OG000|Outcome|Rufinamide|500 mg 1 week, followed by 1000 mg for 7 weeks
10906586|NCT00595231|OG001|Outcome|Placebo|Placebo, 0 mg tablets
10906587|NCT00595231|EG000|Reported Event|Rufinamide|500 mg for 1 week followed by 1000 mg for 7 weeks
10906588|NCT00595231|EG001|Reported Event|Placebo|0 mg tablet
10906589|NCT00595270|BG000|Baseline|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
10906590|NCT00595270|BG001|Baseline|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
10906591|NCT00595270|BG002|Baseline|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
10906592|NCT00595270|BG003|Baseline|Total|Total of all reporting groups
10906593|NCT00595270|FG000|Participant Flow|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
10906594|NCT00595270|FG001|Participant Flow|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
10906595|NCT00595270|FG002|Participant Flow|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
10906596|NCT00595270|OG000|Outcome|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
10906597|NCT00595270|OG001|Outcome|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
10906598|NCT00595270|OG002|Outcome|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
10906599|NCT00595270|EG000|Reported Event|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
10906600|NCT00595270|EG001|Reported Event|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
11342163|NCT03699124|OG000|Outcome|GP 1: Two Doses of FD MVA-BN--Lot 1|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
10906601|NCT00595270|EG002|Reported Event|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
10906602|NCT00595309|BG000|Baseline|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
10906603|NCT00595309|FG000|Participant Flow|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
10906604|NCT00595309|OG000|Outcome|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
10906605|NCT00595309|EG000|Reported Event|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
10906606|NCT00595335|BG000|Baseline|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
10906607|NCT00595335|BG001|Baseline|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
10906608|NCT00595335|BG002|Baseline|Total|Total of all reporting groups
10906609|NCT00595335|FG000|Participant Flow|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
10906610|NCT00595335|FG001|Participant Flow|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
10906611|NCT00595335|OG000|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
10906612|NCT00595335|OG001|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
10906613|NCT00595335|OG000|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
10906614|NCT00595335|OG001|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
10906615|NCT00595335|OG000|Outcome|Rituximab|Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
10906616|NCT00595335|OG001|Outcome|Placebo|Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
10906617|NCT00595335|EG000|Reported Event|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
10906618|NCT00595335|EG001|Reported Event|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
10906619|NCT00595361|BG000|Baseline|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
10906620|NCT00595361|BG001|Baseline|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
10906621|NCT00595361|BG002|Baseline|Total|Total of all reporting groups
10906622|NCT00595361|FG000|Participant Flow|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
10906623|NCT00595361|FG001|Participant Flow|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
10906624|NCT00595361|OG000|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
10906625|NCT00595361|OG001|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
10906626|NCT00595361|EG000|Reported Event|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
10906627|NCT00595361|EG001|Reported Event|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
10906628|NCT00595413|BG000|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
10906629|NCT00595413|BG001|Baseline|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
10906630|NCT00595413|BG002|Baseline|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
10906631|NCT00595413|BG003|Baseline|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
10906632|NCT00595413|BG004|Baseline|Total|Total of all reporting groups
10906633|NCT00595413|FG000|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
10906634|NCT00595413|FG001|Participant Flow|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
10906635|NCT00595413|FG002|Participant Flow|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
10906636|NCT00595413|FG003|Participant Flow|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
10906637|NCT00595413|OG000|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
10906638|NCT00595413|OG001|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
10906639|NCT00595413|OG002|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
10906640|NCT00595413|OG003|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
10906641|NCT00595413|EG000|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
10906642|NCT00595413|EG001|Reported Event|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
10906643|NCT00595413|EG002|Reported Event|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
10906644|NCT00595413|EG003|Reported Event|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
10906645|NCT00595465|BG000|Baseline|IC51 Batch IC51/07E/006A|
10906646|NCT00595465|BG001|Baseline|IC51 Batch IC51/07E/007A|
10906647|NCT00595465|BG002|Baseline|IC51 Batch IC51/07E/008A|
10906648|NCT00595465|BG003|Baseline|Total|Total of all reporting groups
10906649|NCT00595465|FG000|Participant Flow|IC51 Batch IC51/07E/006A|
10906650|NCT00595465|FG001|Participant Flow|IC51 Batch IC51/07E/007A|
10906651|NCT00595465|FG002|Participant Flow|IC51 Batch IC51/07E/008A|
10906652|NCT00595465|OG000|Outcome|IC51 Batch IC51/07E/006A|
10906653|NCT00595465|OG001|Outcome|IC51 Batch IC51/07E/007A|
10906654|NCT00595465|OG002|Outcome|IC51 Batch IC51/07E/008A|
10906655|NCT00595465|EG000|Reported Event|IC51 Batch IC51/07E/006A|
10906656|NCT00595465|EG001|Reported Event|IC51 Batch IC51/07E/007A|
10906657|NCT00595465|EG002|Reported Event|IC51 Batch IC51/07E/008A|
10906658|NCT00595478|BG000|Baseline|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
10906659|NCT00595478|BG001|Baseline|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
10906660|NCT00595478|BG002|Baseline|Total|Total of all reporting groups
10906661|NCT00595478|FG000|Participant Flow|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
10906662|NCT00595478|FG001|Participant Flow|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
10906663|NCT00595478|OG000|Outcome|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
10906664|NCT00595478|OG001|Outcome|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
10906665|NCT00595478|EG000|Reported Event|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
10906666|NCT00595478|EG001|Reported Event|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
10906667|NCT00595504|BG000|Baseline|Ramelteon|
10906668|NCT00595504|BG001|Baseline|Placebo|sugar pill
10906669|NCT00595504|BG002|Baseline|Total|Total of all reporting groups
10906670|NCT00595504|FG000|Participant Flow|Ramelteon|
10906671|NCT00595504|FG001|Participant Flow|Placebo|sugar pill
10906672|NCT00595504|OG000|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
10906673|NCT00595504|OG001|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
10906674|NCT00595504|EG000|Reported Event|Ramelteon|
10906675|NCT00595504|EG001|Reported Event|Placebo|sugar pill
10906676|NCT00595517|BG000|Baseline|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
10906677|NCT00595517|FG000|Participant Flow|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
10906678|NCT00595517|OG000|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
10906679|NCT00595517|EG000|Reported Event|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
10906680|NCT00595530|BG000|Baseline|Protocol for Administering Ketamine to Patients|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
10906681|NCT00595530|FG000|Participant Flow|Procedure for Administering Ketamine to SCDpatients|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
10906682|NCT00595530|OG000|Outcome|Ketamine|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
10906683|NCT00595530|OG000|Outcome|Ketamine|"This group will receive ketamine~ketamine: Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr.~Dosing Regimen:~Patients begin the ketamine infusion at 0.05 mg/kg/hr.~4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if:~patient's pain has not improved to an acceptable level~side effects remain acceptable~4 hrs or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hr~4 hrs or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~Maximum dose of ketamine is limited to 300 mg per 24 hrs~Patient may receive ketamine up to 72 hrs after initiation."
10906684|NCT00595530|EG000|Reported Event|Ketamine|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
10906685|NCT00595556|BG000|Baseline|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
10906686|NCT00595556|BG001|Baseline|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
10906687|NCT00595556|BG002|Baseline|Total|Total of all reporting groups
10906688|NCT00595556|FG000|Participant Flow|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
10906689|NCT00595556|FG001|Participant Flow|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
10906690|NCT00595556|OG000|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
10906691|NCT00595556|OG001|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
10906692|NCT00595556|EG000|Reported Event|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
10906693|NCT00595556|EG001|Reported Event|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
10906694|NCT00595621|BG000|Baseline|"MGP-1 ON"|"Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
10906695|NCT00595621|BG001|Baseline|"MGP-1 OFF"|"Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
10906696|NCT00595621|BG002|Baseline|Total|Total of all reporting groups
10906697|NCT00595621|FG000|Participant Flow|"MGP-1 ON"|"Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
10906698|NCT00595621|FG001|Participant Flow|"MGP-1 OFF"|"Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
10906699|NCT00595621|OG000|Outcome|"MGP-1 ON"|"Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
11172522|NCT02010203|FG002|Participant Flow|Phase II: High-Dose HS-410 Plus BCG|"In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96~BCG: Vaccine derived from a live bacterium"
11172523|NCT02010203|FG003|Participant Flow|Phase II: Placebo Plus BCG|"In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.~Placebo: Injection containing sterile solution but no cells~BCG: Vaccine derived from a live bacterium"
10906700|NCT00595621|OG001|Outcome|"MGP-1 OFF"|"Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
10906701|NCT00595621|EG000|Reported Event|Open Label Run|"Experimental Pacemaker on for 6 weeks during the open label phase (preceding MGP-1 ON and MPG-1 OFF randomization phases).~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
10906702|NCT00595621|EG001|Reported Event|"MGP-1 ON"|"Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase.~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
10906703|NCT00595621|EG002|Reported Event|"MPG-1 OFF"|"Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase.~Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)"
10906704|NCT00595764|BG000|Baseline|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
10906705|NCT00595764|BG001|Baseline|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
10906706|NCT00595764|BG002|Baseline|Total|Total of all reporting groups
10906707|NCT00595764|FG000|Participant Flow|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
10906708|NCT00595764|FG001|Participant Flow|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
10906709|NCT00595764|OG000|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
10906710|NCT00595764|OG001|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
10906711|NCT00595764|EG000|Reported Event|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
10906712|NCT00595764|EG001|Reported Event|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
10906713|NCT00595790|BG000|Baseline|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
10906714|NCT00595790|BG001|Baseline|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
10906715|NCT00595790|BG002|Baseline|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
10906716|NCT00595790|BG003|Baseline|Total|Total of all reporting groups
10906717|NCT00595790|FG000|Participant Flow|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
10906718|NCT00595790|FG001|Participant Flow|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
10906719|NCT00595790|FG002|Participant Flow|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
10906720|NCT00595790|OG000|Outcome|IC51 1 x 12 mcg|
10906721|NCT00595790|OG001|Outcome|IC51 2x6 mcg|
10906722|NCT00595790|OG002|Outcome|IC51 1x6 mcg|
10906723|NCT00595790|EG000|Reported Event|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
10906724|NCT00595790|EG001|Reported Event|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
10906725|NCT00595790|EG002|Reported Event|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
10906726|NCT00595868|BG000|Baseline|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
10906727|NCT00595868|BG001|Baseline|Placebo|Placebo once per day for 2-8 weeks
10906728|NCT00595868|BG002|Baseline|Total|Total of all reporting groups
10906729|NCT00595868|FG000|Participant Flow|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
10906730|NCT00595868|FG001|Participant Flow|Placebo|Placebo once per day for 2-8 weeks
10906731|NCT00595868|OG000|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
10906732|NCT00595868|OG001|Outcome|Placebo|Placebo once per day for 2-8 weeks
10906733|NCT00595868|EG000|Reported Event|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
10906734|NCT00595868|EG001|Reported Event|Placebo|Placebo once per day for 2-8 weeks
10906735|NCT00595881|BG000|Baseline|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
10906736|NCT00595881|FG000|Participant Flow|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
10906737|NCT00595881|OG000|Outcome|Clinical Exam Alone|Patients will have data collected from their clinical examination alone
10906738|NCT00595881|OG001|Outcome|Clinical Exam+ Ultrasound|Patients will have data collected following the addition of a bedside ultrasound performed to the clinical exam.
10906739|NCT00595881|EG000|Reported Event|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
10906740|NCT00595946|BG000|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
10906741|NCT00595946|BG001|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
10906742|NCT00595946|BG002|Baseline|Total|Total of all reporting groups
10906743|NCT00595946|FG000|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for up to 12 weeks
10906744|NCT00595946|FG001|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for up to 12 weeks
10906745|NCT00595946|OG000|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
10906746|NCT00595946|OG001|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
10906747|NCT00595946|EG000|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
10906748|NCT00595946|EG001|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
10906749|NCT00595959|BG000|Baseline|Laser Treatment|CLiRpath Photoablation Atherectomy System
10906750|NCT00595959|FG000|Participant Flow|Laser Treatment|CLiRpath Photoablation Atherectomy System
10906751|NCT00595959|OG000|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
10906752|NCT00595959|EG000|Reported Event|Laser Treatment|CLiRpath Photoablation Atherectomy System
10906753|NCT00596011|BG000|Baseline|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
10906754|NCT00596011|BG001|Baseline|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
10906755|NCT00596011|BG002|Baseline|Total|Total of all reporting groups
10906756|NCT00596011|FG000|Participant Flow|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
10906757|NCT00596011|FG001|Participant Flow|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
10906758|NCT00596011|OG000|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
10906759|NCT00596011|OG001|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
10906760|NCT00596011|EG000|Reported Event|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
10906761|NCT00596011|EG001|Reported Event|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
10906762|NCT00596102|BG000|Baseline|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
10906763|NCT00596102|BG001|Baseline|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
10906764|NCT00596102|BG002|Baseline|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
10906765|NCT00596102|BG003|Baseline|Total|Total of all reporting groups
10906766|NCT00596102|FG000|Participant Flow|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
10906767|NCT00596102|FG001|Participant Flow|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
10906768|NCT00596102|FG002|Participant Flow|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
10906769|NCT00596102|OG000|Outcome|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
10906770|NCT00596102|EG000|Reported Event|IC51 Month 6|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
10906771|NCT00596102|EG001|Reported Event|JE-VAX|no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
10906772|NCT00596102|EG002|Reported Event|Placebo|no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
10906773|NCT00596102|EG003|Reported Event|IC51 Month 60|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60
10906774|NCT00596167|BG000|Baseline|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
10906775|NCT00596167|FG000|Participant Flow|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
10906776|NCT00596167|OG000|Outcome|Intravenous Antibiotic (Vancomycin)|This study will have only one arm. All six participants in the study will receive an intravenous dose of the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
10906777|NCT00596167|EG000|Reported Event|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
10906778|NCT00596271|BG000|Baseline|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
10906779|NCT00596271|BG001|Baseline|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
10906780|NCT00596271|BG002|Baseline|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
10906781|NCT00596271|BG003|Baseline|Total|Total of all reporting groups
10906782|NCT00596271|FG000|Participant Flow|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
10906783|NCT00596271|FG001|Participant Flow|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
10906784|NCT00596271|FG002|Participant Flow|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
10906785|NCT00596271|OG000|Outcome|IC51 and Placebo|
10906786|NCT00596271|OG001|Outcome|IC51 and HAVRIX|
10906787|NCT00596271|OG000|Outcome|HAVRIX + Placebo|
10906788|NCT00596271|OG001|Outcome|IC51 + HAVRIX|
10906789|NCT00596271|EG000|Reported Event|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
10906790|NCT00596271|EG001|Reported Event|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
10906791|NCT00596271|EG002|Reported Event|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
10906792|NCT00596362|BG000|Baseline|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
10915098|NCT00634049|OG000|Outcome|Renally Impaired|Renally Impaired (RI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. Renal impairment was defined as yes for participants who had a baseline eGFR-MDRD < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
10906793|NCT00596362|FG000|Participant Flow|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
10906794|NCT00596362|OG000|Outcome|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
10906795|NCT00596362|EG000|Reported Event|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
10906796|NCT00596427|BG000|Baseline|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
10906797|NCT00596427|BG001|Baseline|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
10906798|NCT00596427|BG002|Baseline|Total|Total of all reporting groups
10906799|NCT00596427|FG000|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
10906800|NCT00596427|FG001|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
10906801|NCT00596427|OG000|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
10906802|NCT00596427|OG001|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
10906803|NCT00596427|OG000|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75grams/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
10906804|NCT00596427|EG000|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
10906805|NCT00596427|EG001|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
10906806|NCT00596440|BG000|Baseline|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
11172524|NCT02010203|FG004|Participant Flow|Phase II: High-Dose HS-410|"In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96"
11172525|NCT02010203|OG000|Outcome|Phase I: HS-410 Low Dose|HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
11172526|NCT02010203|OG000|Outcome|Phase II: HS-410 Low-Dose Plus BCG|"In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96~BCG: Vaccine derived from a live bacterium"
10906807|NCT00596440|BG001|Baseline|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
10906808|NCT00596440|BG002|Baseline|Total|Total of all reporting groups
10906809|NCT00596440|FG000|Participant Flow|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
10906810|NCT00596440|FG001|Participant Flow|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
10906811|NCT00596440|OG000|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
10906812|NCT00596440|OG001|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
10906813|NCT00596440|EG000|Reported Event|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
10906814|NCT00596440|EG001|Reported Event|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
10906815|NCT00596453|BG000|Baseline|Placebo|Placebo: Placebo twice a day for 14 days
10906816|NCT00596453|BG001|Baseline|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
10906817|NCT00596453|BG002|Baseline|Total|Total of all reporting groups
10906818|NCT00596453|FG000|Participant Flow|Placebo|Placebo: Placebo twice a day for 14 days
10906819|NCT00596453|FG001|Participant Flow|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
10906820|NCT00596453|OG000|Outcome|Placebo|Placebo: Placebo twice a day for 14 days
10906821|NCT00596453|OG001|Outcome|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
10906822|NCT00596453|EG000|Reported Event|Placebo|Placebo: Placebo twice a day for 14 days
10906823|NCT00596453|EG001|Reported Event|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
10906824|NCT00596466|BG000|Baseline|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
10906825|NCT00596466|FG000|Participant Flow|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
10906826|NCT00596466|OG000|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
10906827|NCT00596466|EG000|Reported Event|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
10906828|NCT00596622|BG000|Baseline|Bipolar Depressed Subjects Treated With Lithium|"Participants with bipolar depression picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
10906829|NCT00596622|BG001|Baseline|Bipolar Manic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
10906830|NCT00596622|BG002|Baseline|Bipolar Euthymic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
10906831|NCT00596622|BG003|Baseline|Total|Total of all reporting groups
10906832|NCT00596622|FG000|Participant Flow|Bipolar Subjects Who Were Included in Lithium Treatment Arm|"Participants with bipolar disorder who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
10906833|NCT00596622|OG000|Outcome|Bipolar Depressed Participants Treated|"Participants with bipolar depression who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
10906834|NCT00596622|OG001|Outcome|Bipolar Manic Subjects Treated|"Participants with bipolar mania who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
10906835|NCT00596622|OG002|Outcome|Bipolar Euthymic Subjects Treated|"Participants with bipolar euthymia who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
10906836|NCT00596622|OG000|Outcome|Bipolar Manic Subjects Treated|"Bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
10906837|NCT00596622|OG001|Outcome|Bipolar Depressed Subjects Treated|"Bipolar depression picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
10906838|NCT00596622|OG002|Outcome|Bipolar Euthymic Subjects Treated|"Bipolar euthymia picture response before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
10906839|NCT00596622|EG000|Reported Event|Bipolar Participants Treated|"Participants with bipolar disorder who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks.~Adverse Events information was collected irrespective of the sub-grouping"
10906840|NCT00596635|BG000|Baseline|No Cranberry Capsules|Control Group No Cranberry Capsule
10906841|NCT00596635|BG001|Baseline|One Cranberry Capsule|1 650mg cranberry capsule daily
10906842|NCT00596635|BG002|Baseline|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
10906843|NCT00596635|BG003|Baseline|Total|Total of all reporting groups
10906844|NCT00596635|FG000|Participant Flow|No Cranberry Capsules|Control Group No Cranberry Capsule
10906845|NCT00596635|FG001|Participant Flow|One Cranberry Capsule|1 650mg cranberry capsule daily
10906846|NCT00596635|FG002|Participant Flow|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
10906847|NCT00596635|OG000|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
10906848|NCT00596635|OG001|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
10906849|NCT00596635|OG002|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
10906850|NCT00596635|EG000|Reported Event|No Cranberry Capsules|Control Group No Cranberry Capsule
10906851|NCT00596635|EG001|Reported Event|One Cranberry Capsule|1 650mg cranberry capsule daily
10906852|NCT00596635|EG002|Reported Event|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
11342164|NCT03699124|OG001|Outcome|GP 2: Two Doses of FD MVA-BN--Lot 2|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
10906853|NCT00596687|BG000|Baseline|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
10906854|NCT00596687|BG001|Baseline|SSRI|Sliding scale regular insulin four-times daily.
10906855|NCT00596687|BG002|Baseline|Total|Total of all reporting groups
10906856|NCT00596687|FG000|Participant Flow|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine. A total of 0.5 units of insulin/day given, half as basal glargine insulin once a day and the other half as mealtime glulisine given three times a day at meals.
10906857|NCT00596687|FG001|Participant Flow|SSRI|Sliding scale regular insulin four-times daily if blood glucose > 140 before meals and at bedtime. The sliding scale regimen was per the hospital protocol.
10906858|NCT00596687|OG000|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
10906859|NCT00596687|OG001|Outcome|SSRI|Sliding scale regular insulin four-times daily.
10906860|NCT00596687|EG000|Reported Event|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
10906861|NCT00596687|EG001|Reported Event|SSRI|Sliding scale regular insulin four-times daily.
10906862|NCT00596752|BG000|Baseline|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
10906863|NCT00596752|BG001|Baseline|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
10906864|NCT00596752|BG002|Baseline|Total|Total of all reporting groups
10906865|NCT00596752|FG000|Participant Flow|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
10906866|NCT00596752|FG001|Participant Flow|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
10906867|NCT00596752|OG000|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
10906868|NCT00596752|OG001|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
10906869|NCT00596752|EG000|Reported Event|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
10906870|NCT00596752|EG001|Reported Event|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
10915099|NCT00634049|OG001|Outcome|Not Renally Impaired|Not Renally Impaired (NRI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
10915100|NCT00634049|OG000|Outcome|Isavuconazole|Participants received Isavuconazole intravenous (IV) or per oral (PO) over period of 2 days, on days 1 and 2 three doses of 200 mg were administered every 8 hours for a total of six doses. From Day 3 to End of Treatment (EOT) maintenance dose of 200 mg isavuconazole was administered once daily up to 180 days; with an option for extended treatment under specified criteria.
10906871|NCT00594386|BG000|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10906872|NCT00594386|FG000|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10906873|NCT00594386|OG000|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10906874|NCT00594386|EG000|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10906875|NCT00596817|BG000|Baseline|Open-label Period (APTS)|
10906876|NCT00596817|BG001|Baseline|Placebo - Double-blind Period (FAS)|Placebo : capsules, daily, orally
10906877|NCT00596817|BG002|Baseline|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
10906878|NCT00596817|BG003|Baseline|Total|Total of all reporting groups
10906879|NCT00596817|FG000|Participant Flow|Placebo|Placebo : capsules, daily, orally
10906880|NCT00596817|FG001|Participant Flow|Vortioxetine: 5 or 10 mg|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
10906881|NCT00596817|OG000|Outcome|Placebo|capsules, daily, orally
10906882|NCT00596817|OG001|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
10906883|NCT00596817|EG000|Reported Event|Open-label Period (APTS)|
11172527|NCT02010203|OG001|Outcome|Phase II: High-Dose HS-410 Plus BCG|"In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96~BCG: Vaccine derived from a live bacterium"
10906884|NCT00596817|EG001|Reported Event|Placebo - Double-blind Period (FAS)|
10906885|NCT00596817|EG002|Reported Event|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|
10906886|NCT00596830|BG000|Baseline|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
10906887|NCT00596830|BG001|Baseline|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
10906888|NCT00596830|BG002|Baseline|Total|Total of all reporting groups
10906889|NCT00596830|FG000|Participant Flow|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
10906890|NCT00596830|FG001|Participant Flow|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
10906891|NCT00596830|OG000|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
10906892|NCT00596830|OG001|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
10906893|NCT00596830|EG000|Reported Event|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
10906894|NCT00596830|EG001|Reported Event|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
10906895|NCT00596934|BG000|Baseline|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
10906896|NCT00596934|FG000|Participant Flow|NASH02|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
10906897|NCT00596934|OG000|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
10906898|NCT00596934|OG000|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
10906899|NCT00596934|OG000|Outcome|Metreleptin Treatment Group|"Treatment group~metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
10906900|NCT00596934|EG000|Reported Event|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
10906901|NCT00596960|BG000|Baseline|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
10906902|NCT00596960|BG001|Baseline|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
10906903|NCT00596960|BG002|Baseline|Total|Total of all reporting groups
10906904|NCT00596960|FG000|Participant Flow|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
10906905|NCT00596960|FG001|Participant Flow|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
10906906|NCT00596960|OG000|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
10906907|NCT00596960|OG001|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
10906908|NCT00596960|EG000|Reported Event|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
10906909|NCT00596960|EG001|Reported Event|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
10906910|NCT00597012|BG000|Baseline|Arthroscopic Partial Meniscectomy|Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
10906911|NCT00597012|BG001|Baseline|Physical Therapy|Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
10906912|NCT00597012|BG002|Baseline|Total|Total of all reporting groups
10906913|NCT00597012|FG000|Participant Flow|Arthroscopic Partial Meniscectomy (APM)|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
10906914|NCT00597012|FG001|Participant Flow|Physical Therapy (PT)|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
10906915|NCT00597012|OG000|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
10906916|NCT00597012|OG001|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
10906917|NCT00597012|OG000|Outcome|Arthroscopic Partial Meniscectomy (APM)|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
10906918|NCT00597012|OG001|Outcome|Physical Therapy (PT)|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
10906919|NCT00597012|EG000|Reported Event|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
10906920|NCT00597012|EG001|Reported Event|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
10906921|NCT00597038|BG000|Baseline|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
10906922|NCT00597038|BG001|Baseline|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
10906923|NCT00597038|BG002|Baseline|Total|Total of all reporting groups
10906924|NCT00597038|FG000|Participant Flow|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
10906925|NCT00597038|FG001|Participant Flow|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
10906926|NCT00597038|OG000|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC)
10906927|NCT00597038|OG000|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
10906928|NCT00597038|OG000|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
10906929|NCT00597038|OG001|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
10906930|NCT00597038|EG000|Reported Event|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
10906931|NCT00597038|EG001|Reported Event|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
10906932|NCT00597116|BG000|Baseline|Vandetanib|Vandetanib 300 mg/day oral
10906933|NCT00597116|BG001|Baseline|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
10906934|NCT00597116|BG002|Baseline|Total|Total of all reporting groups
10906935|NCT00597116|FG000|Participant Flow|Vandetanib|Vandetanib 300 mg/day oral
10906936|NCT00597116|FG001|Participant Flow|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
10906937|NCT00597116|OG000|Outcome|Vandetanib|Vandetanib 300 mg/day oral
10906938|NCT00597116|OG001|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
10906939|NCT00597116|EG000|Reported Event|Vandetanib|Vandetanib 300 mg/day oral
10906940|NCT00597116|EG001|Reported Event|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
10906941|NCT00597207|BG000|Baseline|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
10906942|NCT00597207|BG001|Baseline|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
10906943|NCT00597207|BG002|Baseline|Total|Total of all reporting groups
10906944|NCT00597207|FG000|Participant Flow|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
10906945|NCT00597207|FG001|Participant Flow|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
10906946|NCT00597207|OG000|Outcome|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
10906947|NCT00597207|OG001|Outcome|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
10906948|NCT00597207|EG000|Reported Event|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
10906949|NCT00597207|EG001|Reported Event|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
10906950|NCT00597246|BG000|Baseline|Participants With Brain Tumors|"FACBC, Methionine: F-18 labeled FACBC is prepared stereo-specifically in a semi-automated, NCA procedure utilizing the General Electric FDG MicroLab, a system employing a quaternary 4-aminopyridinium resin to effect F-18 fluorination. The triflate species is displaced with F-18 fluoride in the MicroLab, and then the 1-t-butyl carbamate-3- trifluoromethane sulfonoxy-1-cyclobutane-1-carboxylic acid methyl ester is hydrolyzed with 1 N HCl. The final product is isotonic and sterile, and has been utilized in animal experiments. The product was obtained in 30% radiochemical yield after 65 minutes from EOB. The radiochemical purity was greater than 95% and no preparative HPLC was required. The procedure could be considered routine, and is performed on the FDG synthetic module without changes either to the programming or to the cassettes.~PET Scan: GE Advance PET scanner for sequential body imaging"
10906951|NCT00597246|FG000|Participant Flow|Participants With Brain Tumors|"FACBC, Methionine: F-18 labeled FACBC is prepared stereo-specifically in a semi-automated, NCA procedure utilizing the General Electric FDG MicroLab, a system employing a quaternary 4-aminopyridinium resin to effect F-18 fluorination. The triflate species is displaced with F-18 fluoride in the MicroLab, and then the 1-t-butyl carbamate-3- trifluoromethane sulfonoxy-1-cyclobutane-1-carboxylic acid methyl ester is hydrolyzed with 1 N HCl. The final product is isotonic and sterile, and has been utilized in animal experiments. The product was obtained in 30% radiochemical yield after 65 minutes from EOB. The radiochemical purity was greater than 95% and no preparative HPLC was required. The procedure could be considered routine, and is performed on the FDG synthetic module without changes either to the programming or to the cassettes.~PET Scan: GE Advance PET scanner for sequential body imaging"
10906952|NCT00597246|OG000|Outcome|Participants With Brain Tumors|"FACBC, Methionine: F-18 labeled FACBC is prepared stereo-specifically in a semi-automated, NCA procedure utilizing the General Electric FDG MicroLab, a system employing a quaternary 4-aminopyridinium resin to effect F-18 fluorination. The triflate species is displaced with F-18 fluoride in the MicroLab, and then the 1-t-butyl carbamate-3- trifluoromethane sulfonoxy-1-cyclobutane-1-carboxylic acid methyl ester is hydrolyzed with 1 N HCl. The final product is isotonic and sterile, and has been utilized in animal experiments. The product was obtained in 30% radiochemical yield after 65 minutes from EOB. The radiochemical purity was greater than 95% and no preparative HPLC was required. The procedure could be considered routine, and is performed on the FDG synthetic module without changes either to the programming or to the cassettes.~PET Scan: GE Advance PET scanner for sequential body imaging"
10906953|NCT00597246|EG000|Reported Event|Participants With Brain Tumors|"FACBC, Methionine: F-18 labeled FACBC is prepared stereo-specifically in a semi-automated, NCA procedure utilizing the General Electric FDG MicroLab, a system employing a quaternary 4-aminopyridinium resin to effect F-18 fluorination. The triflate species is displaced with F-18 fluoride in the MicroLab, and then the 1-t-butyl carbamate-3- trifluoromethane sulfonoxy-1-cyclobutane-1-carboxylic acid methyl ester is hydrolyzed with 1 N HCl. The final product is isotonic and sterile, and has been utilized in animal experiments. The product was obtained in 30% radiochemical yield after 65 minutes from EOB. The radiochemical purity was greater than 95% and no preparative HPLC was required. The procedure could be considered routine, and is performed on the FDG synthetic module without changes either to the programming or to the cassettes.~PET Scan: GE Advance PET scanner for sequential body imaging"
10906954|NCT00597272|BG000|Baseline|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906955|NCT00597272|BG001|Baseline|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906956|NCT00597272|BG002|Baseline|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906957|NCT00597272|BG003|Baseline|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
10906958|NCT00597272|BG004|Baseline|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
10906959|NCT00597272|BG005|Baseline|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
10906960|NCT00597272|BG006|Baseline|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
10906961|NCT00597272|BG007|Baseline|Total|Total of all reporting groups
10906962|NCT00597272|FG000|Participant Flow|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906963|NCT00597272|FG001|Participant Flow|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906964|NCT00597272|FG002|Participant Flow|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906965|NCT00597272|FG003|Participant Flow|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
10906966|NCT00597272|FG004|Participant Flow|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
10906967|NCT00597272|FG005|Participant Flow|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
10906968|NCT00597272|FG006|Participant Flow|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
10906969|NCT00597272|OG000|Outcome|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906970|NCT00597272|OG001|Outcome|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906971|NCT00597272|OG002|Outcome|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906972|NCT00597272|OG003|Outcome|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
10906973|NCT00597272|OG004|Outcome|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
10906974|NCT00597272|OG005|Outcome|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
10906975|NCT00597272|OG006|Outcome|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
10906976|NCT00597272|EG000|Reported Event|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906977|NCT00597272|EG001|Reported Event|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906978|NCT00597272|EG002|Reported Event|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
10906979|NCT00597272|EG003|Reported Event|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
10906980|NCT00597272|EG004|Reported Event|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
10906981|NCT00597272|EG005|Reported Event|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
10906982|NCT00597272|EG006|Reported Event|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
10906983|NCT00597376|BG000|Baseline|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement~Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
10906984|NCT00597376|BG001|Baseline|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement~Cerefolin NAC placebo : Placebo tablet once a day"
10906985|NCT00597376|BG002|Baseline|Total|Total of all reporting groups
10906986|NCT00597376|FG000|Participant Flow|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement~Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
10906987|NCT00597376|FG001|Participant Flow|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement~Cerefolin NAC placebo : Placebo tablet once a day"
10906988|NCT00597376|OG000|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
10906989|NCT00597376|OG001|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
10906990|NCT00597376|EG000|Reported Event|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
10906991|NCT00597376|EG001|Reported Event|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
10906992|NCT00597402|BG000|Baseline|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
10906993|NCT00597402|FG000|Participant Flow|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
10906994|NCT00597402|OG000|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
10915101|NCT00634049|EG000|Reported Event|Renally Impaired (RI)|Renal impairment was defined as yes for participants who have a baseline as eGFR < 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula.
10915102|NCT00634049|EG001|Reported Event|Not Renally Impaired (NRI)|"Not Renally impaired participants were defined as no if they have a baseline eGFR-MDRD~≥ 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula."
10906995|NCT00597402|EG000|Reported Event|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
10906996|NCT00597428|BG000|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
10906997|NCT00597428|BG001|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
10906998|NCT00597428|BG002|Baseline|Total|Total of all reporting groups
10906999|NCT00597428|FG000|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for 12 weeks
10907000|NCT00597428|FG001|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for 12 weeks
10907001|NCT00597428|OG000|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
10907002|NCT00597428|OG001|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
10907003|NCT00597428|EG000|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
10907004|NCT00597428|EG001|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
11172528|NCT02010203|OG002|Outcome|Phase II: Placebo Plus BCG|"In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.~Placebo: Injection containing sterile solution but no cells~BCG: Vaccine derived from a live bacterium"
11172529|NCT02010203|OG003|Outcome|Phase II: High-Dose HS-410|"In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96"
11172530|NCT02010203|EG000|Reported Event|Phase I: HS-410 Low Dose|"In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96"
11172531|NCT02010203|EG001|Reported Event|Phase II: HS-410 Low-Dose Plus BCG|"In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96~BCG: Vaccine derived from a live bacterium"
11172532|NCT02010203|EG002|Reported Event|Phase II: High-Dose HS-410 Plus BCG|"In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96~BCG: Vaccine derived from a live bacterium"
11172533|NCT02010203|EG003|Reported Event|Phase II: Placebo Plus BCG|"In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.~Placebo: Injection containing sterile solution but no cells~BCG: Vaccine derived from a live bacterium"
10907005|NCT00597493|BG000|Baseline|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
11172534|NCT02010203|EG004|Reported Event|Phase II: High-Dose HS-410|"In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.~HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96"
10907006|NCT00597493|FG000|Participant Flow|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
10907007|NCT00597493|OG000|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
10907008|NCT00597493|OG000|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
11172535|NCT02010216|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
10907009|NCT00597493|OG001|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
10907010|NCT00597493|OG002|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
10907011|NCT00597493|OG003|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
10915103|NCT00634088|BG000|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib administered daily in escalating cohorts, beginning with 1000 mg, orally once a day, for 7 to 14 consecutive days in Cycle 1 prior to the first administration of ixabepilone. Then lapatinib administered daily, orally once a day, for a 21-day cycle. After the lapatinib lead-in phase, ixabepilone administered as a 3-hour IV infusion in escalating doses, beginning with 32 mg/m^2.
10907012|NCT00597493|EG000|Reported Event|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
10907013|NCT00597506|BG000|Baseline|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
10907014|NCT00597506|FG000|Participant Flow|Drug: Bevacizumab and Everolimus|Open-label, non-randomized expanded cohort trial of refractory metastatic colorectal cancer subjects treated on 28 day cycles with the following treatment regimen: 10 mg/kg intravenous bevacizumab on days 1 and 15 each cycle and 10 mg everolimus(RAD001) daily by mouth.
10907015|NCT00597506|OG000|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
10907016|NCT00597506|EG000|Reported Event|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
10907017|NCT00597519|BG000|Baseline|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
10907018|NCT00597519|FG000|Participant Flow|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
10907019|NCT00597519|OG000|Outcome|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
10907020|NCT00597519|EG000|Reported Event|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
10907021|NCT00597545|BG000|Baseline|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
11172536|NCT02010216|FG000|Participant Flow|Tocilizumab [RoActemra/Actemra]|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
11172537|NCT02010216|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
11172538|NCT02010216|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
10907022|NCT00597545|BG001|Baseline|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
10907023|NCT00597545|BG002|Baseline|Total|Total of all reporting groups
10907024|NCT00597545|FG000|Participant Flow|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
10907025|NCT00597545|FG001|Participant Flow|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
10907026|NCT00597545|OG000|Outcome|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
10907027|NCT00597545|OG001|Outcome|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
10907028|NCT00597545|EG000|Reported Event|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
11172539|NCT02010255|BG000|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
11172540|NCT02010255|BG001|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
10907029|NCT00597545|EG001|Reported Event|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
10907030|NCT00597558|BG000|Baseline|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
10907031|NCT00597558|FG000|Participant Flow|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
10907032|NCT00597558|OG000|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
10907033|NCT00597558|EG000|Reported Event|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
10907034|NCT00597584|BG000|Baseline|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
10907035|NCT00597584|BG001|Baseline|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
10907036|NCT00597584|BG002|Baseline|Total|Total of all reporting groups
10907037|NCT00597584|FG000|Participant Flow|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
10907038|NCT00597584|FG001|Participant Flow|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
10907039|NCT00597584|OG000|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
10907040|NCT00597584|OG001|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
10907041|NCT00597584|EG000|Reported Event|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
10907042|NCT00597584|EG001|Reported Event|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
10907043|NCT00597675|BG000|Baseline|Placebo|Oat flour taken daily as a placebo
10907044|NCT00597675|BG001|Baseline|Peanut OIT|Peanut flour ingested daily as active OIT treatment
10907045|NCT00597675|BG002|Baseline|Total|Total of all reporting groups
10907046|NCT00597675|FG000|Participant Flow|Placebo|Oat flour taken daily as a placebo
10907047|NCT00597675|FG001|Participant Flow|Peanut OIT|Peanut flour ingested daily as active OIT treatment
10907048|NCT00597675|OG000|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
10907049|NCT00597675|OG000|Outcome|Placebo|Oat flour taken daily as a placebo
10907050|NCT00597675|OG001|Outcome|Peanut OIT|Peanut flour ingested daily as active OIT treatment
10907051|NCT00597675|EG000|Reported Event|Open Label Phase-Peanut OIT|All subjects receiving open-label peanut OIT from the point of unblinding through the end of the treatment phase.
10907052|NCT00597675|EG001|Reported Event|Blinded Phase-Placebo|Patients receiving oat flour as a placebo during the initial 12 months of therapy.
10907053|NCT00597675|EG002|Reported Event|Blinded Phase-Peanut OIT|Patients receiving peanut flour as active OIT during the initial 12 months of therapy.
10907054|NCT00597701|BG000|Baseline|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
10907055|NCT00597701|BG001|Baseline|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
10907056|NCT00597701|BG002|Baseline|Total|Total of all reporting groups
10907057|NCT00597701|FG000|Participant Flow|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
10907058|NCT00597701|FG001|Participant Flow|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
10907059|NCT00597701|OG000|Outcome|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
10907060|NCT00597701|OG001|Outcome|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
10907061|NCT00597701|EG000|Reported Event|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
10907062|NCT00597701|EG001|Reported Event|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
10907063|NCT00597714|BG000|Baseline|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907064|NCT00597714|BG001|Baseline|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907065|NCT00597714|BG002|Baseline|Total|Total of all reporting groups
10907066|NCT00597714|FG000|Participant Flow|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907067|NCT00597714|FG001|Participant Flow|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907068|NCT00597714|FG002|Participant Flow|Donor|"5-6/6 matched sibling who meets the other donor criteria is the first choice,~Matched Unrelated Donor (MUD) is the second choice*, and~3-5/6 partially matched family member (if 5/6 then this donor is not a sibling as that would be first choice) is the third choice for donor type.~Multiple choices for 3-5/6 human leukocyte antigen (HLA) matched family member donors order of choice will be best match, then cytomegalovirus (CMV) negativity, then Killer-cell immunoglobulin-like receptors (KIR) mismatching (for natural killer [NK] cell activity), then history of pregnancy. All subjects without an available matched sibling must have a donor search initiated with the national bank. If potential high resolution matches are found but not utilized, the reason for proceeding with a partially matched family member should be documented (i.e. donor not available, not enough time to allow MUD donor work up and collection due to high risk nature of the subject's disease, etc)."
11172541|NCT02010255|BG002|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
10907069|NCT00597714|OG000|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907070|NCT00597714|OG000|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10915104|NCT00634088|BG001|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg), lapatinib 1250 mg administered orally once a day, every day, for 7 to 14 consecutive days prior to the first administration of ixabepilone. Then lapatinib administered orally once a day, every day, for a 21-day cycle. After lapatinib lead-in period, ixabepilone administered as a 3-hour IV infusion of 32 mg/m^2.
11091110|NCT01533038|FG000|Participant Flow|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
11091111|NCT01533038|FG001|Participant Flow|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
11091112|NCT01533038|OG000|Outcome|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
11091113|NCT01533038|OG001|Outcome|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
11091114|NCT01533038|EG000|Reported Event|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
11091115|NCT01533038|EG001|Reported Event|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
11091116|NCT01533077|BG000|Baseline|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
11091117|NCT01533077|BG001|Baseline|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
11091118|NCT01533077|BG002|Baseline|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
11091119|NCT01533077|BG003|Baseline|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
11091120|NCT01533077|BG004|Baseline|Total|Total of all reporting groups
11091121|NCT01533077|FG000|Participant Flow|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
11091122|NCT01533077|FG001|Participant Flow|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
11091123|NCT01533077|FG002|Participant Flow|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
10907071|NCT00597714|OG000|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. For the myeloid group, the prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907072|NCT00597714|OG000|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907073|NCT00597714|OG000|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907074|NCT00597714|EG000|Reported Event|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907075|NCT00597714|EG001|Reported Event|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
10907076|NCT00597727|BG000|Baseline|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops) at the beginning of the study.
10907077|NCT00597727|BG001|Baseline|Blinded Placebo SLIT|"Blinded subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.~Placebo SLIT: Liquid glycerin without peanut which are dosed under the tongue."
10907078|NCT00597727|BG002|Baseline|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
11091124|NCT01533077|FG003|Participant Flow|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
11091125|NCT01533077|OG000|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
11091126|NCT01533077|OG001|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
10907079|NCT00597727|BG003|Baseline|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
10907080|NCT00597727|BG004|Baseline|Total|Total of all reporting groups
10907081|NCT00597727|FG000|Participant Flow|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
10907082|NCT00597727|FG001|Participant Flow|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
10907083|NCT00597727|FG002|Participant Flow|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
10907084|NCT00597727|FG003|Participant Flow|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
10907085|NCT00597727|FG004|Participant Flow|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
10907086|NCT00597727|OG000|Outcome|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
10907087|NCT00597727|OG001|Outcome|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
10907088|NCT00597727|OG002|Outcome|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
10907089|NCT00597727|OG003|Outcome|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
10907090|NCT00597727|OG000|Outcome|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
10907091|NCT00597727|OG001|Outcome|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
10907092|NCT00597727|OG002|Outcome|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
10907093|NCT00597727|EG000|Reported Event|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
10907094|NCT00597727|EG001|Reported Event|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
10907095|NCT00597727|EG002|Reported Event|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
10907096|NCT00597727|EG003|Reported Event|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
10907097|NCT00597727|EG004|Reported Event|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
10907098|NCT00597753|BG000|Baseline|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
10907099|NCT00597753|BG001|Baseline|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
10907100|NCT00597753|BG002|Baseline|Total|Total of all reporting groups
10907101|NCT00597753|FG000|Participant Flow|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
10907102|NCT00597753|FG001|Participant Flow|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
10907103|NCT00597753|OG000|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
11091127|NCT01533077|OG002|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
11091128|NCT01533077|OG000|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
11091129|NCT01533077|EG000|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg.
11091130|NCT01533077|EG001|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h.
10907104|NCT00597753|OG001|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
10907105|NCT00597753|EG000|Reported Event|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
10907106|NCT00597753|EG001|Reported Event|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
10907107|NCT00597766|BG000|Baseline|20mg Triamcinolone|Low dose group.
10907108|NCT00597766|BG001|Baseline|40mg Triamcinolone|Standard dose group
10907109|NCT00597766|BG002|Baseline|60mg Triamcinolone|High dose group
10907110|NCT00597766|BG003|Baseline|Total|Total of all reporting groups
10907111|NCT00597766|FG000|Participant Flow|20mg Triamcinolone|Low dose group.
10907112|NCT00597766|FG001|Participant Flow|40mg Triamcinolone|Standard dose group
10907113|NCT00597766|FG002|Participant Flow|60mg Triamcinolone|High dose group
10907114|NCT00597766|OG000|Outcome|20mg Triamcinolone|Low dose group.
10907115|NCT00597766|OG001|Outcome|40mg Triamcinolone|Standard dose group
10907116|NCT00597766|OG002|Outcome|60mg Triamcinolone|High dose group
10907117|NCT00597766|EG000|Reported Event|20mg Triamcinolone|Low dose group.
10907118|NCT00597766|EG001|Reported Event|40mg Triamcinolone|Standard dose group
10907119|NCT00597766|EG002|Reported Event|60mg Triamcinolone|High dose group
10907120|NCT00597818|BG000|Baseline|Placebo|Matching placebo
10907121|NCT00597818|BG001|Baseline|Cobiprostone QD|Cobiprostone 18 mcg once daily (QD)
10907122|NCT00597818|BG002|Baseline|Cobiprostone BID|Cobiprostone 18 mcg twice daily (BID)
10907123|NCT00597818|BG003|Baseline|Cobiprostone TID|Cobiprostone 18 mcg three times daily (TID)
10907124|NCT00597818|BG004|Baseline|Total|Total of all reporting groups
10907125|NCT00597818|FG000|Participant Flow|Placebo|Matching placebo
10907126|NCT00597818|FG001|Participant Flow|18 mcg|Cobiprostone 18 mcg once daily (QD)
10907127|NCT00597818|FG002|Participant Flow|36 mcg|Cobiprostone 18 mcg twice daily (BID)
10907128|NCT00597818|FG003|Participant Flow|54 mcg|Cobiprostone 18 mcg three times daily (TID)
10907129|NCT00597818|OG000|Outcome|Placebo|Matching placebo
10907130|NCT00597818|OG001|Outcome|Cobiprostone QD|Cobiprostone 18 mcg once daily (QD)
10907131|NCT00597818|OG002|Outcome|Cobiprostone BID|Cobiprostone 18 mcg twice daily (BID)
10907132|NCT00597818|OG003|Outcome|Cobiprostone TID|Cobiprostone 18 mcg three times daily (TID)
10907133|NCT00597818|EG000|Reported Event|Placebo|Matching placebo
10907134|NCT00597818|EG001|Reported Event|Cobiprostone QD|Cobiprostone 18 mcg once daily (QD)
10907135|NCT00597818|EG002|Reported Event|Cobiprostone BID|Cobiprostone 18 mcg twice daily (BID)
10907136|NCT00597818|EG003|Reported Event|Cobiprostone TID|Cobiprostone 18 mcg three times daily (TID)
10907137|NCT00597896|BG000|Baseline|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
10907138|NCT00597896|BG001|Baseline|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
10907139|NCT00597896|BG002|Baseline|Total|Total of all reporting groups
10907140|NCT00597896|FG000|Participant Flow|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
10907141|NCT00597896|FG001|Participant Flow|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
10907142|NCT00597896|OG000|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
10907143|NCT00597896|OG001|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
10907144|NCT00597896|OG000|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
10907145|NCT00597896|EG000|Reported Event|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
10907146|NCT00597896|EG001|Reported Event|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
10907147|NCT00597935|BG000|Baseline|SSLF+BPMT|Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
10907148|NCT00597935|BG001|Baseline|SSLF+USUAL|Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
10907149|NCT00597935|BG002|Baseline|ULS+BPMT|Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
10907150|NCT00597935|BG003|Baseline|ULS+USUAL|Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
10907151|NCT00597935|BG004|Baseline|Total|Total of all reporting groups
10907152|NCT00597935|FG000|Participant Flow|SSLF+BPMT|Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
10907153|NCT00597935|FG001|Participant Flow|SSLF+USUAL|Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
10907154|NCT00597935|FG002|Participant Flow|ULS+BPMT|Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
10907155|NCT00597935|FG003|Participant Flow|ULS+USUAL|Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
10907156|NCT00597935|OG000|Outcome|SSLF+BPMT|Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
10907157|NCT00597935|OG001|Outcome|SSLF+USUAL|Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
10907158|NCT00597935|OG002|Outcome|ULS+BPMT|Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
10907159|NCT00597935|OG003|Outcome|ULS+USUAL|Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
10907160|NCT00597935|EG000|Reported Event|ULS+BPMT|Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
10907161|NCT00597935|EG001|Reported Event|SSLF+BPMT|Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
10907162|NCT00597935|EG002|Reported Event|ULS+USUAL|Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
10907163|NCT00597935|EG003|Reported Event|SSLF+USUAL|Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
10907164|NCT00598078|BG000|Baseline|All Study Participants|All treated study participants
10907165|NCT00598078|FG000|Participant Flow|Regimen A, Then B, Then C|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2:Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm; Day 3:Placebo at ~8am, ~10am, and ~12pm
10907166|NCT00598078|FG001|Participant Flow|Regimen A, Then C, Then B|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2: Placebo at ~8am, ~10am, and ~12pm; Day 3: Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm;
10907167|NCT00598078|OG000|Outcome|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
10907168|NCT00598078|OG001|Outcome|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
10907169|NCT00598078|OG002|Outcome|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
10907170|NCT00598078|EG000|Reported Event|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
10907171|NCT00598078|EG001|Reported Event|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
10907172|NCT00598078|EG002|Reported Event|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
10907173|NCT00598273|BG000|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10907174|NCT00598273|BG001|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907175|NCT00598273|BG002|Baseline|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907176|NCT00598273|BG003|Baseline|Total|Total of all reporting groups
11091131|NCT01533077|EG002|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly.
11091132|NCT01533077|EG003|Reported Event|Sinemet® 100/25 mg|Sinemet® 100/25 mg.
11091133|NCT01533116|BG000|Baseline|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
10907177|NCT00598273|FG000|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10907178|NCT00598273|FG001|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907179|NCT00598273|FG002|Participant Flow|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907180|NCT00598273|OG000|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10907181|NCT00598273|OG001|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907182|NCT00598273|OG002|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907183|NCT00598273|EG000|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10907184|NCT00598273|EG001|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907185|NCT00598273|EG002|Reported Event|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907186|NCT00598442|BG000|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10907187|NCT00598442|BG001|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907188|NCT00598442|BG002|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907189|NCT00598442|BG003|Baseline|Total|Total of all reporting groups
10907190|NCT00598442|FG000|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10907191|NCT00598442|FG001|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907192|NCT00598442|FG002|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907193|NCT00598442|OG000|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10907194|NCT00598442|OG001|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907195|NCT00598442|OG002|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907196|NCT00598442|EG000|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10907197|NCT00598442|EG001|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907198|NCT00598442|EG002|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10907199|NCT00598481|BG000|Baseline|Gene Therapy (Pivotal)|Infusion of autologous cluster of differentiation (CD)34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan
10907200|NCT00598481|FG000|Participant Flow|Gene Therapy|Infusion of autologous cluster of differentiation (CD)34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan
10907201|NCT00598481|OG000|Outcome|Gene Therapy (Pivotal)|Infusion of autologous cluster of differentiation (CD)34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan
10907202|NCT00598481|OG000|Outcome|Severe Infections (Before Gene Therapy)|This is the rate of severe infections prior to gene therapy.
10907203|NCT00598481|OG001|Outcome|Severe Infections (After Gene Therapy)|This is the rate of severe infections post gene therapy, taken from 3 months post gene therapy to three years post gene therapy.
10907204|NCT00598481|OG000|Outcome|Gene Therapy ITT Population|Included all subjects who were treated with gene therapy and had at least 1 year post therapy during the 0-3 year follow up
10907205|NCT00598481|EG000|Reported Event|Gene Therapy (Pivotal)|Infusion of autologous cluster of differentiation (CD)34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan
10907206|NCT00598507|BG000|Baseline|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
10907207|NCT00598507|FG000|Participant Flow|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
10907208|NCT00598507|OG000|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
10907209|NCT00598507|EG000|Reported Event|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
10907210|NCT00598559|BG000|Baseline|IV Acetaminophen 1g q6h|All Subjects Randomized to Receive IV acetaminophen 1g administered every 6 hours.
10907211|NCT00598559|BG001|Baseline|IV Acetaminophen 650 mg q4h|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
10907212|NCT00598559|BG002|Baseline|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
10907213|NCT00598559|BG003|Baseline|Total|Total of all reporting groups
10907214|NCT00598559|FG000|Participant Flow|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
10907215|NCT00598559|FG001|Participant Flow|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
10907216|NCT00598559|FG002|Participant Flow|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
10907217|NCT00598559|OG000|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
10907218|NCT00598559|OG001|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
10907219|NCT00598559|OG002|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
10907220|NCT00598559|EG000|Reported Event|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
10907221|NCT00598559|EG001|Reported Event|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
10907222|NCT00598559|EG002|Reported Event|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
10907223|NCT00598585|BG000|Baseline|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
10907224|NCT00598585|BG001|Baseline|Placebo|Placebo: Placebo tid for 6 weeks
10907225|NCT00598585|BG002|Baseline|Total|Total of all reporting groups
10907226|NCT00598585|FG000|Participant Flow|Sildenafil|25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
10907227|NCT00598585|FG001|Participant Flow|Placebo|Placebo: Placebo
10907228|NCT00598585|OG000|Outcome|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
10907229|NCT00598585|OG001|Outcome|Placebo|Placebo: Placebo
10907230|NCT00598585|EG000|Reported Event|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
10907231|NCT00598585|EG001|Reported Event|Placebo|Placebo: Placebo
11091134|NCT01533116|BG001|Baseline|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
11091135|NCT01533116|BG002|Baseline|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
11091136|NCT01533116|BG003|Baseline|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
11091137|NCT01533116|BG004|Baseline|Total|Total of all reporting groups
11091138|NCT01533116|FG000|Participant Flow|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
10907232|NCT00598650|BG000|Baseline|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
10907233|NCT00598650|FG000|Participant Flow|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
10907234|NCT00598650|OG000|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
10907235|NCT00598650|OG001|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
10907236|NCT00598650|EG000|Reported Event|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
10907237|NCT00598663|BG000|Baseline|Off/On|"6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]~4 month wash out period~6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]"
10907238|NCT00598663|BG001|Baseline|On/Off|"6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]~4 month wash out period~6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]"
10907239|NCT00598663|BG002|Baseline|Total|Total of all reporting groups
10907240|NCT00598663|FG000|Participant Flow|Off/On|"Sequence Off/On~6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) and Self Monitoring Blood Glucose~Wash out period: 4 months~6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) + personal continuous glucose monitoring (personal CGM)"
10907241|NCT00598663|FG001|Participant Flow|On/Off|"Sequence On/Off~6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) + personal continuous glucose monitoring (personal CGM)~Wash out period: 4 months~6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) and Self Monitoring Blood Glucose"
10907242|NCT00598663|OG000|Outcome|Sensor Off Arm|"6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]~Arms/Groups are reported on a per intervention basis"
10907243|NCT00598663|OG001|Outcome|Sensor ON Arm|"6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]~Arms/Groups are reported on a per intervention basis"
10907244|NCT00598663|OG001|Outcome|Sensor On Arm|"6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]~Arms/Groups are reported on a per intervention basis"
10907245|NCT00598663|OG000|Outcome|Sensor Off|"6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]~Arms/Groups are reported on a per intervention basis"
10907246|NCT00598663|OG001|Outcome|Sensor On|"6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]~Arms/Groups are reported on a per intervention basis"
10907247|NCT00598663|EG000|Reported Event|Sensor Off|6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]
10907248|NCT00598663|EG001|Reported Event|Sensor On|6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]
10907249|NCT00598689|BG000|Baseline|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
10907250|NCT00598689|BG001|Baseline|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
10907251|NCT00598689|BG002|Baseline|Total|Total of all reporting groups
10907252|NCT00598689|FG000|Participant Flow|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
10907253|NCT00598689|FG001|Participant Flow|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
10907254|NCT00598689|OG000|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
10907255|NCT00598689|OG001|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
10907256|NCT00598689|EG000|Reported Event|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
10907257|NCT00598689|EG001|Reported Event|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
10907258|NCT00598702|BG000|Baseline|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
10907259|NCT00598702|BG001|Baseline|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907260|NCT00598702|BG002|Baseline|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907261|NCT00598702|BG003|Baseline|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907262|NCT00598702|BG004|Baseline|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907263|NCT00598702|BG005|Baseline|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907264|NCT00598702|BG006|Baseline|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907265|NCT00598702|BG007|Baseline|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
10907266|NCT00598702|BG008|Baseline|Total|Total of all reporting groups
10907267|NCT00598702|FG000|Participant Flow|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
10907268|NCT00598702|FG001|Participant Flow|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907269|NCT00598702|FG002|Participant Flow|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907270|NCT00598702|FG003|Participant Flow|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907271|NCT00598702|FG004|Participant Flow|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907272|NCT00598702|FG005|Participant Flow|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907273|NCT00598702|FG006|Participant Flow|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907274|NCT00598702|FG007|Participant Flow|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
10907275|NCT00598702|OG000|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
10907276|NCT00598702|OG001|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907277|NCT00598702|OG002|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
11172542|NCT02010255|BG003|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172543|NCT02010255|BG004|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
11172544|NCT02010255|BG005|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
11172545|NCT02010255|BG006|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
11172546|NCT02010255|BG007|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
11172547|NCT02010255|BG008|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
11172548|NCT02010255|BG009|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172549|NCT02010255|BG010|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
11172550|NCT02010255|BG011|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172551|NCT02010255|BG012|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
11172552|NCT02010255|BG013|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11172553|NCT02010255|BG014|Baseline|Total|Total of all reporting groups
11172554|NCT02010255|FG000|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
11172555|NCT02010255|FG001|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172556|NCT02010255|FG002|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
11172557|NCT02010255|FG003|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172558|NCT02010255|FG004|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
11172559|NCT02010255|FG005|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
11172560|NCT02010255|FG006|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
11172561|NCT02010255|FG007|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
11172562|NCT02010255|FG008|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
11172563|NCT02010255|FG009|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172564|NCT02010255|FG010|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
11172565|NCT02010255|FG011|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172566|NCT02010255|FG012|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
11172567|NCT02010255|FG013|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11172568|NCT02010255|OG000|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
11172569|NCT02010255|OG001|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172570|NCT02010255|OG002|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
11172571|NCT02010255|OG003|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172572|NCT02010255|OG004|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
11172573|NCT02010255|OG005|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
11172574|NCT02010255|OG006|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
11172575|NCT02010255|OG007|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
11172576|NCT02010255|OG008|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
11172577|NCT02010255|OG009|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172578|NCT02010255|OG010|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
11172579|NCT02010255|OG011|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172580|NCT02010255|OG012|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
11172581|NCT02010255|OG013|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11172582|NCT02010255|OG000|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
11172583|NCT02010255|OG000|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172584|NCT02010255|OG001|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172585|NCT02010255|OG002|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
10907278|NCT00598702|OG003|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907279|NCT00598702|OG004|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907280|NCT00598702|OG005|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907281|NCT00598702|OG006|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
11172586|NCT02010255|OG003|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
11172587|NCT02010255|OG004|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172588|NCT02010255|OG005|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172589|NCT02010255|OG006|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11172590|NCT02010255|OG000|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
11172591|NCT02010255|OG004|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
11172592|NCT02010255|OG005|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
11172593|NCT02010255|OG006|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
11172594|NCT02010255|OG007|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172595|NCT02010255|OG008|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
10907282|NCT00598702|OG007|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
10907283|NCT00598702|EG000|Reported Event|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
10907284|NCT00598702|EG001|Reported Event|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907285|NCT00598702|EG002|Reported Event|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907286|NCT00598702|EG003|Reported Event|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907287|NCT00598702|EG004|Reported Event|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907288|NCT00598702|EG005|Reported Event|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
10907289|NCT00598702|EG006|Reported Event|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
10907290|NCT00598702|EG007|Reported Event|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
10907291|NCT00598806|BG000|Baseline|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
11172596|NCT02010255|OG009|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172597|NCT02010255|OG000|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11172598|NCT02010255|OG001|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
10907292|NCT00598806|BG001|Baseline|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
10907293|NCT00598806|BG002|Baseline|Total|Total of all reporting groups
10907294|NCT00598806|FG000|Participant Flow|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
10907295|NCT00598806|FG001|Participant Flow|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
10907296|NCT00598806|OG000|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
10907297|NCT00598806|OG001|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
10907298|NCT00598806|EG000|Reported Event|Apaziquone|Apaziquone: TURBT + a single intravesical dose of EOquin® 4mg in 40ml instilled into the bladder post-TURBT
10907299|NCT00598806|EG001|Reported Event|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
10907300|NCT00598819|BG000|Baseline|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
10907301|NCT00598819|FG000|Participant Flow|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
11172599|NCT02010255|OG002|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11172600|NCT02010255|OG003|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
11172601|NCT02010255|OG004|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
10907302|NCT00598819|OG000|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
10907303|NCT00598819|EG000|Reported Event|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
10907304|NCT00598832|BG000|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
10907305|NCT00598832|BG001|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
10907306|NCT00598832|BG002|Baseline|Total|Total of all reporting groups
10907307|NCT00598832|FG000|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
10907308|NCT00598832|FG001|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
10907309|NCT00598832|OG000|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
10907310|NCT00598832|OG001|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
10907311|NCT00598832|EG000|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
10907312|NCT00598832|EG001|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
10907313|NCT00598871|BG000|Baseline|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
10907314|NCT00598871|BG001|Baseline|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
11172602|NCT02010255|OG005|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
10907315|NCT00598871|BG002|Baseline|Total|Total of all reporting groups
10907316|NCT00598871|FG000|Participant Flow|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
10907317|NCT00598871|FG001|Participant Flow|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
10907318|NCT00598871|OG000|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
10907319|NCT00598871|OG001|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
10907320|NCT00598871|EG000|Reported Event|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
10907321|NCT00598871|EG001|Reported Event|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
10907322|NCT00598975|BG000|Baseline|NKTR-102 100 mg/m2 + Cetuximab|All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
10907323|NCT00598975|BG001|Baseline|NKTR-102 125 mg/m2 + Cetuximab|All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
10907324|NCT00598975|BG002|Baseline|Total|Total of all reporting groups
10907325|NCT00598975|FG000|Participant Flow|NKTR-102 100 mg/m2 + Cetuximab|"NKTR-102 100 mg/m2 + Cetuximab Arm~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
10907326|NCT00598975|FG001|Participant Flow|NKTR-102 125 mg/m2 + Cetuximab|"NKTR-102 125 mg/m2 + Cetuximab Arm~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
10907327|NCT00598975|OG000|Outcome|NKTR-102 100 mg/m2 + Cetuximab|"NKTR-102 100 mg/m2 + Cetuximab Arm~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
10907328|NCT00598975|OG001|Outcome|NKTR-102 125 mg/m2 + Cetuximab|"NKTR-102 125 mg/m2 + Cetuximab Arm~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
10907329|NCT00598975|OG002|Outcome|Total|"NKTR-102 Overall Total~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
10907330|NCT00598975|EG000|Reported Event|NKTR-102 100 mg/m2 + Cetuximab|"NKTR-102 100 mg/m2 + Cetuximab Arm~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
10907331|NCT00598975|EG001|Reported Event|NKTR-102 125 mg/m2 + Cetuximab|"NKTR-102 125 mg/m2 + Cetuximab Arm~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
10907332|NCT00598975|EG002|Reported Event|Total|"NKTR-102 Overall Tota~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.l"
10907333|NCT00599014|BG000|Baseline|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
10907334|NCT00599014|FG000|Participant Flow|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
10907335|NCT00599014|OG000|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
10907336|NCT00599014|EG000|Reported Event|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
10907337|NCT00599053|BG000|Baseline|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
11172603|NCT02010255|OG006|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
10907338|NCT00599053|BG001|Baseline|Expectant (Usual) Management|Intervention at the discretion of the attending physician
10907339|NCT00599053|BG002|Baseline|Total|Total of all reporting groups
10907340|NCT00599053|FG000|Participant Flow|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
10907341|NCT00599053|FG001|Participant Flow|Expectant (Usual) Management|Intervention at the discretion of the attending physician
10907342|NCT00599053|OG000|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
10907343|NCT00599053|OG001|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
10907344|NCT00599053|EG000|Reported Event|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
10907345|NCT00599053|EG001|Reported Event|Expectant (Usual) Management|Intervention at the discretion of the attending physician
10907346|NCT00599196|BG000|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10907347|NCT00599196|FG000|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10907348|NCT00599196|OG000|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10907349|NCT00599196|EG000|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
10907350|NCT00599248|BG000|Baseline|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
10907351|NCT00599248|BG001|Baseline|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
10907352|NCT00599248|BG002|Baseline|Total|Total of all reporting groups
10907353|NCT00599248|FG000|Participant Flow|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint administered by single intra-articular injection"
10907354|NCT00599248|FG001|Participant Flow|Active Treatment (TG-C) 2|"TissueGene-C at 1 x 10e7 cells/joint~TissueGene-C: TissueGene-C at 1x10e7 cells/joint administered by single intra-articular injection"
10907355|NCT00599248|FG002|Participant Flow|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint administered by single intra-articular injection"
10907356|NCT00599248|FG003|Participant Flow|Placebo Control (DMEM)|"Placebo Control (DMEM)~Placebo: Placebo control (DMEM) administered by a single intraarticular injection"
10907357|NCT00599248|OG000|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
10907358|NCT00599248|OG001|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint~TissueGene-C: TissueGene-C at 1x107 cells/joint to be administered by a single intra-articular injection"
10907359|NCT00599248|OG002|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
10907360|NCT00599248|OG003|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
10907361|NCT00599248|OG001|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint~TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
10907362|NCT00599248|EG000|Reported Event|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
10907363|NCT00599248|EG001|Reported Event|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
10907364|NCT00599313|BG000|Baseline|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
10907365|NCT00599313|FG000|Participant Flow|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
10907366|NCT00599313|OG000|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
10907367|NCT00599313|EG000|Reported Event|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
10907368|NCT00599326|BG000|Baseline|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
10907369|NCT00599326|FG000|Participant Flow|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
10907370|NCT00599326|OG000|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
10907371|NCT00599326|EG000|Reported Event|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
11172604|NCT02010255|OG007|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
10907372|NCT00599339|BG000|Baseline|Overall|For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
10907373|NCT00599339|FG000|Participant Flow|Overall|For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
10907374|NCT00599339|OG000|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
10907375|NCT00599339|OG001|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
10907376|NCT00599339|OG002|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
10907377|NCT00599339|OG003|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
10907378|NCT00599339|OG004|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
10907379|NCT00599339|OG005|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
10907380|NCT00599339|OG006|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
10907381|NCT00599339|OG007|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
10907382|NCT00599339|OG008|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
10907383|NCT00599339|OG009|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
10907384|NCT00599339|OG010|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
10907385|NCT00599339|OG011|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
10907386|NCT00599339|OG012|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
10907387|NCT00599339|OG013|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
10907388|NCT00599339|OG014|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
10907389|NCT00599339|OG015|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
10907390|NCT00599339|OG000|Outcome|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.~An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
11172605|NCT02010255|OG008|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
10907391|NCT00599339|OG001|Outcome|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.~An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
10907392|NCT00599339|EG000|Reported Event|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.~An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
10907393|NCT00599339|EG001|Reported Event|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.~An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
10907394|NCT00599521|BG000|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
10907395|NCT00599521|BG001|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
10907396|NCT00599521|BG002|Baseline|Total|Total of all reporting groups
10907397|NCT00599521|FG000|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
10907398|NCT00599521|FG001|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
10907399|NCT00599521|OG000|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
10907400|NCT00599521|OG001|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
10907401|NCT00599521|EG000|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
10907402|NCT00599521|EG001|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
10907403|NCT00599638|BG000|Baseline|Pregabalin Then Placebo|Participants received 75 milligram (mg) capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first intervention period followed by placebo matched to Pregabalin twice daily from Day 1 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
10907404|NCT00599638|BG001|Baseline|Placebo Then Pregabalin|Participants received placebo matched to Pregabalin twice daily from Day 1 to Day 14 in first intervention period followed by Pregabalin 75 mg capsule orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
10907405|NCT00599638|BG002|Baseline|Pregabalin + Placebo Then Pregabalin + PF-00489791|Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with placebo matched to PF-00489791 orally once daily from Day 1 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
10907406|NCT00599638|BG003|Baseline|Pregabalin + PF-00489791 Then Pregabalin + Placebo|Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with a placebo matched to PF-00489791 orally once daily from Day 1 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
10907407|NCT00599638|BG004|Baseline|Total|Total of all reporting groups
10907408|NCT00599638|FG000|Participant Flow|Pregabalin Then Placebo|Participants received 75 milligram (mg) capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first intervention period followed by placebo matched to Pregabalin twice daily from Day 1 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
10907409|NCT00599638|FG001|Participant Flow|Placebo Then Pregabalin|Participants received placebo matched to Pregabalin twice daily from Day 1 to Day 14 in first intervention period followed by Pregabalin 75 mg capsule orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
10907410|NCT00599638|FG002|Participant Flow|Pregabalin + Placebo Then Pregabalin + PF-00489791|Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with placebo matched to PF-00489791 orally once daily from Day 1 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
10907411|NCT00599638|FG003|Participant Flow|Pregabalin + PF-00489791 Then Pregabalin + Placebo|Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with a placebo matched to PF-00489791 orally once daily from Day 1 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
10907412|NCT00599638|OG000|Outcome|Pregabalin + PF-00489791|Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.
10907413|NCT00599638|OG001|Outcome|Pregabalin|Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.
10907414|NCT00599638|OG002|Outcome|Placebo|Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
10907415|NCT00599638|EG000|Reported Event|Pregabalin + PF-00489791|Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.
10907416|NCT00599638|EG001|Reported Event|Pregabalin|Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.
10907417|NCT00599638|EG002|Reported Event|Placebo|Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
10907418|NCT00599755|BG000|Baseline|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
10907419|NCT00599755|FG000|Participant Flow|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
10907420|NCT00599755|OG000|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
10907421|NCT00599755|EG000|Reported Event|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
10907422|NCT00599872|BG000|Baseline|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
10907423|NCT00599872|BG001|Baseline|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
10907424|NCT00599872|BG002|Baseline|Total|Total of all reporting groups
10907425|NCT00599872|FG000|Participant Flow|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
10907426|NCT00599872|FG001|Participant Flow|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
10907427|NCT00599872|OG000|Outcome|Active|Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
10907428|NCT00599872|OG001|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
10907429|NCT00599872|OG000|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
10907430|NCT00599872|OG000|Outcome|Ragweed Allergenic Extract|"Standardized Ragweed Allergenic Extract administered via the sublingual oral route (27.6 to 77.3 Amb a 1 Units)~Standardized Ragweed Allergenic Extract: Standardized Ragweed Allergenic Extract, sublingual oral"
10907431|NCT00599872|OG001|Outcome|Placebo|"Standardized Ragweed Allergenic Extract Placebo via the sublingual oral route~Placebo: Placebo, sublingual oral"
10907432|NCT00599872|OG000|Outcome|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
10907433|NCT00599872|EG000|Reported Event|Ragweed Allergenic Extract|Ragweed Allergenic extract administered once daily at 77.3 Units/Amb a 1.
10907434|NCT00599872|EG001|Reported Event|Placebo|Placebo be administered once daily at 0.0 Units/Amb a 1
10907435|NCT00599924|BG000|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907436|NCT00599924|BG001|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907437|NCT00599924|BG002|Baseline|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907438|NCT00599924|BG003|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
10907439|NCT00599924|BG004|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
10907440|NCT00599924|BG005|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
10907441|NCT00599924|BG006|Baseline|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
10907442|NCT00599924|BG007|Baseline|Total|Total of all reporting groups
10907443|NCT00599924|FG000|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907444|NCT00599924|FG001|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907445|NCT00599924|FG002|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907446|NCT00599924|FG003|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
10907447|NCT00599924|FG004|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
10907448|NCT00599924|FG005|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
10907449|NCT00599924|FG006|Participant Flow|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
10907450|NCT00599924|OG000|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907451|NCT00599924|OG001|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907452|NCT00599924|OG002|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907453|NCT00599924|OG003|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
10907454|NCT00599924|OG004|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
10907455|NCT00599924|OG005|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
10907456|NCT00599924|OG006|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
10907457|NCT00599924|OG000|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907458|NCT00599924|OG001|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
11172606|NCT02010255|OG009|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
10907459|NCT00599924|OG002|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907460|NCT00599924|OG003|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
10907461|NCT00599924|OG004|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
10907462|NCT00599924|EG000|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907463|NCT00599924|EG001|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907464|NCT00599924|EG002|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
10907465|NCT00599924|EG003|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
10907466|NCT00599924|EG004|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
10907467|NCT00599924|EG005|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
10907468|NCT00599924|EG006|Reported Event|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
10907469|NCT00600028|BG000|Baseline|Drug Thalidomide First, Then Placebo|Drug thalidomide 50 - 100 mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
11342165|NCT03699124|OG002|Outcome|GP 3: Two Doses of FD MVA-BN--Lot 3|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
10907470|NCT00600028|BG001|Baseline|Placebo First, Then Thalidomide Drug|Placebo was administered in the first intervention period and Thalidomide 50 - 100 mg daily in the second intervention period(After washout period)
10907471|NCT00600028|BG002|Baseline|Total|Total of all reporting groups
10907472|NCT00600028|FG000|Participant Flow|Drug Thalidomide First, Then Placebo|Drug Thalidomide 50-100mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
10907473|NCT00600028|FG001|Participant Flow|Placebo First, Then Thalidomide Drug|Placebo was administered in the first interventional period and Thalidomide 50-100mg daily in the second interventional period (after washout period).
10907474|NCT00600028|OG000|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
10907475|NCT00600028|OG001|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
10907476|NCT00600028|OG002|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50 - 100 mg by mouth daily in the first intervention period
10907477|NCT00600028|OG003|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
10907478|NCT00600028|OG002|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the first intervention period
10907479|NCT00600028|EG000|Reported Event|Thalidomide|Thalidomide : thalidomide 50 - 100 mg by mouth daily
10907480|NCT00600028|EG001|Reported Event|Placebo|Placebo : Placebo 50-100 mg by mouth per day
10907481|NCT00600067|BG000|Baseline|Placebo|
10907482|NCT00600067|BG001|Baseline|Active|PHEN/TPM 15/92
10907483|NCT00600067|BG002|Baseline|Total|Total of all reporting groups
10907484|NCT00600067|FG000|Participant Flow|Placebo|
10907485|NCT00600067|FG001|Participant Flow|VI-0521|phentermine 15 mg/topiramate 92 mg
10907486|NCT00600067|OG000|Outcome|Placebo|
10907487|NCT00600067|OG001|Outcome|VI-0521|phentermine 15mg/topiramate 92 mg
10907488|NCT00600067|OG001|Outcome|VI-0521|phentermine 15mg/topiramate 92mg
10907489|NCT00600067|EG000|Reported Event|Placebo|
10907490|NCT00600067|EG001|Reported Event|Active|PHEN/TPM 15/92
10907491|NCT00600080|BG000|Baseline|All Subjects|All subjects crossed over to use each treatment for one week
10907492|NCT00600080|FG000|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2.
10907493|NCT00600080|FG001|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2.
10907494|NCT00600080|OG000|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
10907495|NCT00600080|OG001|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
10907496|NCT00600080|EG000|Reported Event|Etafilcon A First Nelfilcon A Second|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2
10907497|NCT00600080|EG001|Reported Event|Nelfilcon A First Etafilcon A Second|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2
10907498|NCT00600106|BG000|Baseline|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
11342166|NCT03699124|EG000|Reported Event|GP 1: Two Doses of FD MVA-BN--Lot 1|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
10907499|NCT00600106|BG001|Baseline|Placebo|1 mg placebo.
10907500|NCT00600106|BG002|Baseline|Total|Total of all reporting groups
10907501|NCT00600106|FG000|Participant Flow|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
10907502|NCT00600106|FG001|Participant Flow|Placebo|1 mg placebo.
10907503|NCT00600106|OG000|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
10907504|NCT00600106|OG001|Outcome|Placebo|1 mg placebo.
10907505|NCT00600106|EG000|Reported Event|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
10907506|NCT00600106|EG001|Reported Event|Placebo|1 mg placebo.
10907507|NCT00600119|BG000|Baseline|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
10907508|NCT00600119|BG001|Baseline|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
10907509|NCT00600119|BG002|Baseline|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
10907510|NCT00600119|BG003|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
10907511|NCT00600119|BG004|Baseline|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
10907512|NCT00600119|BG005|Baseline|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
10907513|NCT00600119|BG006|Baseline|Total|Total of all reporting groups
10907514|NCT00600119|FG000|Participant Flow|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
10907515|NCT00600119|FG001|Participant Flow|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
10907516|NCT00600119|FG002|Participant Flow|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
10907517|NCT00600119|FG003|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
10907518|NCT00600119|FG004|Participant Flow|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
10907519|NCT00600119|FG005|Participant Flow|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
10907520|NCT00600119|OG000|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
10907521|NCT00600119|OG001|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
10907522|NCT00600119|OG002|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
10907523|NCT00600119|OG003|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
10907524|NCT00600119|OG004|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
10907525|NCT00600119|OG005|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
10907526|NCT00600119|EG000|Reported Event|NKTR-118 25 mg|
10907527|NCT00600119|EG001|Reported Event|NKTR-118 5 mg|
10907528|NCT00600119|EG002|Reported Event|NKTR-118 50 mg|
10907529|NCT00600119|EG003|Reported Event|Placebo 25 mg|
10907530|NCT00600119|EG004|Reported Event|Placebo 5 mg|
10907531|NCT00600119|EG005|Reported Event|Placebo 50 mg|
10907532|NCT00600171|BG000|Baseline|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907533|NCT00600171|BG001|Baseline|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907534|NCT00600171|BG002|Baseline|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907535|NCT00600171|BG003|Baseline|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907536|NCT00600171|BG004|Baseline|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907537|NCT00600171|BG005|Baseline|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907538|NCT00600171|BG006|Baseline|Total|Total of all reporting groups
10907539|NCT00600171|FG000|Participant Flow|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907540|NCT00600171|FG001|Participant Flow|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907541|NCT00600171|FG002|Participant Flow|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907542|NCT00600171|FG003|Participant Flow|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907543|NCT00600171|FG004|Participant Flow|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907544|NCT00600171|FG005|Participant Flow|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907545|NCT00600171|OG000|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907546|NCT00600171|OG001|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907547|NCT00600171|OG002|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907548|NCT00600171|OG003|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907549|NCT00600171|OG004|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907550|NCT00600171|OG005|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907551|NCT00600171|OG003|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907552|NCT00600171|OG002|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907553|NCT00600171|EG000|Reported Event|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907554|NCT00600171|EG001|Reported Event|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907555|NCT00600171|EG002|Reported Event|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
11172607|NCT02010255|EG000|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
11172608|NCT02010255|EG001|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172609|NCT02010255|EG002|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
11172610|NCT02010255|EG003|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172611|NCT02010255|EG004|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
11172612|NCT02010255|EG005|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
11172613|NCT02010255|EG006|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
11172614|NCT02010255|EG007|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
11172615|NCT02010255|EG008|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
11172616|NCT02010255|EG009|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
11172617|NCT02010255|EG010|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
11172618|NCT02010255|EG011|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
11172619|NCT02010255|EG012|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
11172620|NCT02010255|EG013|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
11172621|NCT02010359|BG000|Baseline|Lovaza|"Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks~Lovaza"
11172622|NCT02010359|BG001|Baseline|Placebo|"An inactive Placebo (2 pills twice daily) will be given for 8 weeks~Placebo"
11172623|NCT02010359|BG002|Baseline|Total|Total of all reporting groups
11172624|NCT02010359|FG000|Participant Flow|Lovaza|"Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks~Lovaza"
11172625|NCT02010359|FG001|Participant Flow|Placebo|"An inactive Placebo (2 pills twice daily) will be given for 8 weeks~Placebo"
11172626|NCT02010359|OG000|Outcome|Lovaza|"Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks~Lovaza"
11172627|NCT02010359|OG001|Outcome|Placebo|"An inactive Placebo (2 pills twice daily) will be given for 8 weeks~Placebo"
11172628|NCT02010359|EG000|Reported Event|Lovaza|"Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks~Lovaza"
11172629|NCT02010359|EG001|Reported Event|Placebo|"An inactive Placebo (2 pills twice daily) will be given for 8 weeks~Placebo"
11172630|NCT02010567|BG000|Baseline|Cohort A, Phase Ib, Dose Level 1|"CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 by mouth two times a day (PO BID), Monday through Friday (M-F) XRT 180 centigray (cGy)/day, M-F for 6 weeks"
10907556|NCT00600171|EG003|Reported Event|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907557|NCT00600171|EG004|Reported Event|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907558|NCT00600171|EG005|Reported Event|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
10907559|NCT00600340|BG000|Baseline|Bevacizumab Plus Paclitaxel|Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
10907560|NCT00600340|BG001|Baseline|Bevacizumab Plus Capecitabine|Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks
10907561|NCT00600340|BG002|Baseline|Total|Total of all reporting groups
10907562|NCT00600340|FG000|Participant Flow|Bevacizumab Plus Paclitaxel|Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
10907563|NCT00600340|FG001|Participant Flow|Bevacizumab Plus Capecitabine|Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks
10907564|NCT00600340|OG000|Outcome|Bevacizumab Plus Paclitaxel|Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
10907565|NCT00600340|OG001|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
10907566|NCT00600340|EG000|Reported Event|Bevacizumab Plus Paclitaxel|Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
10907567|NCT00600340|EG001|Reported Event|Bevacizumab Plus Capecitabine|Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
10907568|NCT00600353|BG000|Baseline|Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion~Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
10907569|NCT00600353|BG001|Baseline|Group B Lymphoma|Includes patients with Hodgkin's Disease and Non-Hodgkin's lymphoma
10907570|NCT00600353|BG002|Baseline|Total|Total of all reporting groups
10907571|NCT00600353|FG000|Participant Flow|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
10907572|NCT00600353|FG001|Participant Flow|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
10907573|NCT00600353|OG000|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
10907574|NCT00600353|OG001|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
10907575|NCT00600353|EG000|Reported Event|Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
10907576|NCT00600353|EG001|Reported Event|Patients With Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
10907577|NCT00600613|BG000|Baseline|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
10907578|NCT00600613|FG000|Participant Flow|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
10907579|NCT00600613|OG000|Outcome|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
10907580|NCT00600613|EG000|Reported Event|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
10907581|NCT00600704|BG000|Baseline|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
10907582|NCT00600704|BG001|Baseline|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
10907583|NCT00600704|BG002|Baseline|Total|Total of all reporting groups
10907584|NCT00600704|FG000|Participant Flow|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
10907585|NCT00600704|FG001|Participant Flow|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
10907586|NCT00600704|OG000|Outcome|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
10907587|NCT00600704|OG001|Outcome|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
10907588|NCT00600704|EG000|Reported Event|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
10907589|NCT00600704|EG001|Reported Event|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
10907590|NCT00600743|BG000|Baseline|1 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
10907591|NCT00600743|BG001|Baseline|2 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
10907592|NCT00600743|BG002|Baseline|4 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
10907593|NCT00600743|BG003|Baseline|4 MG CCK AGONIST BINGE EATING|Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
10907594|NCT00600743|BG004|Baseline|Total|Total of all reporting groups
10907595|NCT00600743|FG000|Participant Flow|1 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
10907596|NCT00600743|FG001|Participant Flow|2 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
10907597|NCT00600743|FG002|Participant Flow|4 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
10907598|NCT00600743|FG003|Participant Flow|4 MG CCK AGONIST BINGE EATING|Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
10907599|NCT00600743|OG000|Outcome|Binge_4mg Drug|Non-bulimic controls Instruction to binge eat (7 subjects) drug
10907600|NCT00600743|OG001|Outcome|Normal_1mg Drug|Eat normally 1 mg dose drug
10907601|NCT00600743|OG002|Outcome|Normal_2mg Drug|Eat normally 2 mg dose drug
10907602|NCT00600743|OG003|Outcome|Normal_4mg Drug|Eat normally 4 mg dose drug
10907603|NCT00600743|OG004|Outcome|Binge - 4mg Placebo|Non-bulimic controls instruction to binge eat - placebo
10907604|NCT00600743|OG005|Outcome|Normal 1 mg Dose Placebo|Eat normally 1 mg dose placebo
10907605|NCT00600743|OG006|Outcome|Normal_2 mg Dose Placebo|Eat normally 2 mg dose placebo
10907606|NCT00600743|OG007|Outcome|Normal_4 mg Dose Placebo|Eat normally 4 mg dose placebo
10907607|NCT00600743|OG000|Outcome|Binge_4mg d|Binge_4mg drug
10907608|NCT00600743|OG001|Outcome|Normal_1mg d|Normal_1mg drug
10907609|NCT00600743|OG002|Outcome|Normal_2mg d|Normal_2mg drug
10907610|NCT00600743|OG003|Outcome|Normal_4mg d|Normal_4mg drug
10907611|NCT00600743|OG004|Outcome|Binge - 4mg Plc|binge - 4mg placebo
10907612|NCT00600743|OG005|Outcome|Normal 1 mg Placebo|Normal 1 mg dose placebo
10907613|NCT00600743|OG006|Outcome|Normal 2mg_placebo|Normal 2mg_dose_placebo
10907614|NCT00600743|OG007|Outcome|Normal_4mg Placebo|Normal_4mg_dose placebo
10907615|NCT00600743|EG000|Reported Event|Normal|Normal control group
10907616|NCT00600756|BG000|Baseline|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
10907617|NCT00600756|BG001|Baseline|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
10907618|NCT00600756|BG002|Baseline|Total|Total of all reporting groups
10907619|NCT00600756|FG000|Participant Flow|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
10907620|NCT00600756|FG001|Participant Flow|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
10907621|NCT00600756|OG000|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
10907622|NCT00600756|OG001|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
10907623|NCT00600756|EG000|Reported Event|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
10907624|NCT00600756|EG001|Reported Event|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
11091139|NCT01533116|FG001|Participant Flow|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
11091140|NCT01533116|FG002|Participant Flow|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
11091141|NCT01533116|FG003|Participant Flow|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
11091142|NCT01533116|OG000|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
10907625|NCT00600821|BG000|Baseline|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
10907626|NCT00600821|BG001|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
10907627|NCT00600821|BG002|Baseline|Total|Total of all reporting groups
10907628|NCT00600821|FG000|Participant Flow|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mg*minute/milliliter (mg*min/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
10907629|NCT00600821|FG001|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
10907630|NCT00600821|OG000|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
10907631|NCT00600821|OG001|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
10907632|NCT00600821|OG000|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
10907633|NCT00600821|OG001|Outcome|Bevacizumab+ Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
10907634|NCT00600821|EG000|Reported Event|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
10907635|NCT00600821|EG001|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
10907636|NCT00600886|BG000|Baseline|Pasireotide LAR|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
10907637|NCT00600886|BG001|Baseline|Octreotide LAR|Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
10907638|NCT00600886|BG002|Baseline|Total|Total of all reporting groups
11172631|NCT02010567|BG001|Baseline|Cohort A, Phase Ib, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
10907639|NCT00600886|FG000|Participant Flow|Pasireotide LAR|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
11172632|NCT02010567|BG002|Baseline|Cohort A, Phase II, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
11172633|NCT02010567|BG003|Baseline|Cohort B, Phase Ib, Dose Level 1, Weekly|"CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
10907640|NCT00600886|FG001|Participant Flow|Octreotide LAR|Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
10907641|NCT00600886|OG000|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
10907642|NCT00600886|OG001|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
10907643|NCT00600886|OG000|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
10907644|NCT00600886|OG001|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
10907645|NCT00600886|OG000|Outcome|Pasireotide LAR 20 mg|Patients in this arm received Pasireotide LAR 20 mg injection prior to PK sample collection.
10907646|NCT00600886|OG001|Outcome|Pasireotide LAR 40 mg|Patients in this arm received Pasireotide LAR 40 mg injection prior to PK sample collection.
10907647|NCT00600886|OG002|Outcome|Pasireotide LAR 60mg|Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
10907648|NCT00600886|OG000|Outcome|Octreotide LAR 10mg|Patients in this arm received Octreotide LAR 10 mg injection prior to PK sample collection.
10907649|NCT00600886|OG001|Outcome|Octreotide LAR 20 mg|Patients in this arm received Octreotide LAR 20 mg injection prior to PK sample collection.
10907650|NCT00600886|OG002|Outcome|Octreotide LAR 30 mg|Patients in this arm received Octreotide LAR 30 mg injection prior to PK sample collection.
10907651|NCT00600886|OG000|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
10907652|NCT00600886|OG001|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
10907653|NCT00600886|EG000|Reported Event|Pasireotide LAR - up to 26 Months|Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.
10907654|NCT00600886|EG001|Reported Event|Octreotide LAR - up to 26 Months|Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment, only data collected before crossover is included.
10907655|NCT00600886|EG002|Reported Event|Crossed Over to Pasireotide LAR - up to 26 Months|Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.
10907656|NCT00600886|EG003|Reported Event|Crossed Over to Octreotide LAR - up to 26 Months|Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Pasireotide LAR in the core to Octreotide LAR treatment in the extension phase.
10907657|NCT00600886|EG004|Reported Event|Pasireotide LAR - up to EOS|"Includes data from both core and extension phase (up to End-of-study date of 11-Mar-2016) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.~Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26."
10907658|NCT00600886|EG005|Reported Event|Crossed Over to Pasireotide LAR - up to EOS|"Includes all data in the extension phase (up to End-of-study date of 11-Mar-2016) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.~Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26."
10907659|NCT00600925|BG000|Baseline|Gentamicin Group Group|"Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin).~gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy"
10907660|NCT00600925|BG001|Baseline|Control Group|Standard of care, ie, no gentamicin-collagen sponge.
10907661|NCT00600925|BG002|Baseline|Total|Total of all reporting groups
10907662|NCT00600925|FG000|Participant Flow|Gentamicin Group|"Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin).~gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy"
10907663|NCT00600925|FG001|Participant Flow|Control|Standard of care, ie, no gentamicin-collagen sponge.
10907664|NCT00600925|OG000|Outcome|Gentamicin Group|"Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin).~gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy"
10907665|NCT00600925|OG001|Outcome|Control|Standard of care, ie, no gentamicin-collagen sponge.
10907666|NCT00600925|EG000|Reported Event|Gentamicin Group Group|"Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin).~gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy"
10907667|NCT00600925|EG001|Reported Event|Control Group|Standard of care, ie, no gentamicin-collagen sponge.
10907668|NCT00600938|BG000|Baseline|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907669|NCT00600938|BG001|Baseline|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
10907670|NCT00600938|BG002|Baseline|Total|Total of all reporting groups
10907671|NCT00600938|FG000|Participant Flow|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907672|NCT00600938|FG001|Participant Flow|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
10907673|NCT00600938|FG002|Participant Flow|DFO to ICL (Deferoxamine to Deferasirox)|"DFO to ICL (patients who switched from DFO to deferasirox in extension)"
10907674|NCT00600938|FG003|Participant Flow|ICL to DFO (Deferasirox to Deferoxamine)|"ICL to DFO (patients who switched from deferasirox to DFO in extension)"
10907675|NCT00600938|OG000|Outcome|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 months.
11172634|NCT02010567|BG004|Baseline|Cohort B, Phase Ib, Dose Level 2, Weekly|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
10907676|NCT00600938|OG001|Outcome|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 months.
10907677|NCT00600938|OG000|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
10907678|NCT00600938|OG001|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
10907679|NCT00600938|OG001|Outcome|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
10907680|NCT00600938|OG000|Outcome|Core; Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
10907681|NCT00600938|OG001|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
10907682|NCT00600938|OG001|Outcome|Core; Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
10907683|NCT00600938|OG000|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907684|NCT00600938|OG000|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907685|NCT00600938|OG000|Outcome|Extension : ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907686|NCT00600938|OG001|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
11172635|NCT02010567|BG005|Baseline|Total|Total of all reporting groups
10907687|NCT00600938|OG002|Outcome|Extension; DFO to ICL|"DFO to ICL (patients who switched from DFO to deferasirox in extension)"
10907688|NCT00600938|OG003|Outcome|Extension: ICL to DFO|"ICL to DFO (patients who switched from deferasirox to DFO in extension)"
10907689|NCT00600938|OG000|Outcome|Extension: ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907690|NCT00600938|OG002|Outcome|Extension: DFO to ICL|"DFO to ICL (patients who switched from DFO to deferasirox in extension)"
10907691|NCT00600938|OG000|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907692|NCT00600938|EG000|Reported Event|Core Phase - ICL670|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907693|NCT00600938|EG001|Reported Event|Core Phase - DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
10907694|NCT00600938|EG002|Reported Event|Extension Phase - ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
10907695|NCT00600938|EG003|Reported Event|Extension Phase - DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
10907696|NCT00600938|EG004|Reported Event|Extension Phase - DFO to ICL|"DFO to ICL (patients who switched from DFO to deferasirox in extension)"
10907697|NCT00600938|EG005|Reported Event|Extension Phase - ICL to DFO|"ICL to DFO (patients who switched from deferasirox to DFO in extension)"
10907698|NCT00601107|BG000|Baseline|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
10907699|NCT00601107|BG001|Baseline|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
10907700|NCT00601107|BG002|Baseline|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
10907701|NCT00601107|BG003|Baseline|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
10907702|NCT00601107|BG004|Baseline|Total|Total of all reporting groups
10907703|NCT00601107|FG000|Participant Flow|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
10907704|NCT00601107|FG001|Participant Flow|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
10907705|NCT00601107|FG002|Participant Flow|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
10907706|NCT00601107|FG003|Participant Flow|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
10907707|NCT00601107|OG000|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
10907708|NCT00601107|OG001|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
10907709|NCT00601107|OG002|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
10907710|NCT00601107|OG003|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
10907711|NCT00601107|EG000|Reported Event|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
10907712|NCT00601107|EG001|Reported Event|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
10907713|NCT00601107|EG002|Reported Event|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
10907714|NCT00601107|EG003|Reported Event|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
10907715|NCT00601146|BG000|Baseline|Low-dose CT Screening|Annual low-dose chest CT screening
10907716|NCT00601146|FG000|Participant Flow|Low-dose CT Screening|Annual low-dose chest CT screening
10907717|NCT00601146|OG000|Outcome|Low-dose CT Screening|Annual low-dose chest CT screening
10907718|NCT00601146|EG000|Reported Event|Low-dose CT Screening|Annual low-dose chest CT screening
10907719|NCT00601172|BG000|Baseline|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
10907720|NCT00601172|BG001|Baseline|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
10907721|NCT00601172|BG002|Baseline|Total|Total of all reporting groups
10907722|NCT00601172|FG000|Participant Flow|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 milligram [mg] twice daily [BID] orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
10907723|NCT00601172|FG001|Participant Flow|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
10907724|NCT00601172|OG000|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
10907725|NCT00601172|OG001|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
11091143|NCT01533116|OG001|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
10907726|NCT00601172|OG000|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
10907727|NCT00601172|EG000|Reported Event|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
10907728|NCT00601172|EG001|Reported Event|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
10907729|NCT00601250|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
10907730|NCT00601250|BG001|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
10907731|NCT00601250|BG002|Baseline|Total|Total of all reporting groups
10907732|NCT00601250|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
10907733|NCT00601250|FG001|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
10907734|NCT00601250|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
10907735|NCT00601250|OG001|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
10907736|NCT00601250|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
10907737|NCT00601250|EG001|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
10907738|NCT00601354|BG000|Baseline|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
10907739|NCT00601354|BG001|Baseline|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
10907740|NCT00601354|BG002|Baseline|Total|Total of all reporting groups
10907741|NCT00601354|FG000|Participant Flow|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
10907742|NCT00601354|FG001|Participant Flow|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
11091144|NCT01533116|OG002|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
10907743|NCT00601354|OG000|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
10907744|NCT00601354|OG001|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
10907745|NCT00601354|EG000|Reported Event|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
10907746|NCT00601354|EG001|Reported Event|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
10907747|NCT00601367|BG000|Baseline|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.~Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.~flibanserin flexible dose: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the pati"
10907748|NCT00601367|FG000|Participant Flow|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site."
10907749|NCT00601367|OG000|Outcome|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
10907750|NCT00601367|EG000|Reported Event|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
10907751|NCT00601419|BG000|Baseline|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907752|NCT00601419|FG000|Participant Flow|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907753|NCT00601419|OG000|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907754|NCT00601419|OG000|Outcome|<65 Years|Participants younger than 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907755|NCT00601419|OG001|Outcome|>=65 Years|Participants older than or equal to 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907756|NCT00601419|OG000|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907757|NCT00601419|OG001|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907758|NCT00601419|OG000|Outcome|Participants With TSH Deficiency|Participants with TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907759|NCT00601419|OG001|Outcome|Participants Without TSH Deficiency|Participants without TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907760|NCT00601419|OG000|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907761|NCT00601419|OG001|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907762|NCT00601419|OG000|Outcome|<0.021 mg/kg/Week|Participants taking an initial dose of less than 0.021 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
10907763|NCT00601419|OG001|Outcome|>=0.021 mg/kg/Week and <0.042 mg/kg/Week|Participants taking an initial dose of 0.021 mg/kg/week or more and less than 0.042 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
10907764|NCT00601419|OG002|Outcome|>=0.042 mg/kg/Week and <=0.084 mg/kg/Week|Participants taking an initial dose of 0.042 mg/kg/week or more and 0.084 mg/kg/week or less of somatropin for adult growth hormone deficiency according to Japanese package insert.
10907765|NCT00601419|OG003|Outcome|>0.084 mg/kg/Week|Participants taking an initial dose of more than 0.084 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
10907766|NCT00601419|OG000|Outcome|<65 Years|Participants younger than 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
11172636|NCT02010567|FG000|Participant Flow|Cohort A, Phase Ib, Dose Level 1|"CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
11172637|NCT02010567|FG001|Participant Flow|Cohort A, Phase Ib, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
11172638|NCT02010567|FG002|Participant Flow|Cohort A, Phase II, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
11172639|NCT02010567|FG003|Participant Flow|Cohort B, Phase Ib, Dose Level 1, Weekly|"CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
11172640|NCT02010567|FG004|Participant Flow|Cohort B, Phase Ib, Dose Level 2, Weekly|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
11172641|NCT02010567|OG000|Outcome|Dose Escalation Phase Ib|Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
11172642|NCT02010567|OG000|Outcome|All Participants|All resectable participants who received CRLX101 + capecitabine (Cape) and radiation therapy (XRT) regardless of dose and timing of treatment
11172643|NCT02010567|OG000|Outcome|Cohort A, Phase II, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
11172644|NCT02010567|EG000|Reported Event|Cohort A, Phase Ib, Level 1|12mg/m^2 CRLX101 every other week + 825mg/m^2 BID Capecitabine + XRT
11172645|NCT02010567|EG001|Reported Event|Cohort A, Phase Ib, Level 2|15mg/m^2 CRLX101 every other week + 825mg/m^2 BID Capecitabine + XRT
11172646|NCT02010567|EG002|Reported Event|Cohort A, Phase II, Level 2|15mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT
11172647|NCT02010567|EG003|Reported Event|Cohort B, Phase Ib, Level 1|12mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT
11172648|NCT02010567|EG004|Reported Event|Cohort B, Phase Ib, Level 2|15mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT
11172649|NCT02010632|BG000|Baseline|All Study Participants|First intervention: Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 Wash out period: 14 days Second intervention: Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
11172650|NCT02010632|FG000|Participant Flow|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
11172651|NCT02010632|FG001|Participant Flow|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
11172652|NCT02010632|OG000|Outcome|Generic Clopidogrel Product|"Apolets® 75 mg tablet~Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
11172653|NCT02010632|OG001|Outcome|Original Clopidogrel Product|"Plavix® 75mg tablet~Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
11172654|NCT02010632|EG000|Reported Event|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
11172655|NCT02010632|EG001|Reported Event|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
10907767|NCT00601419|OG001|Outcome|>=65 Years|Participants older than or equal to 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
11172656|NCT02010645|BG000|Baseline|Eltrombopag + Decitabine|"Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.~Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.~Eltrombopag: Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.~Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle."
11172657|NCT02010645|FG000|Participant Flow|Eltrombopag + Decitabine|"Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.~Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.~Eltrombopag: Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.~Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle."
11174227|NCT02020369|EG000|Reported Event|Coagulation Factor VIIa (Recombinant): 75 µg/kg|"Coagulation Factor VIIa (Recombinant): 75 µg/kg for 3 months~Coagulation Factor VIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX"
10907768|NCT00601419|OG000|Outcome|Participants With ACTH Deficiency|Participants with ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907769|NCT00601419|OG001|Outcome|Participants Without ACTH Deficiency|Participants without ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907770|NCT00601419|EG000|Reported Event|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
10907771|NCT00601458|BG000|Baseline|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
10907772|NCT00601458|BG001|Baseline|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
10907773|NCT00601458|BG002|Baseline|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
11342167|NCT03699124|EG001|Reported Event|GP 2: Two Doses of FD MVA-BN--Lot 2|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
10907774|NCT00601458|BG003|Baseline|Total|Total of all reporting groups
10907775|NCT00601458|FG000|Participant Flow|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
10907776|NCT00601458|FG001|Participant Flow|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
10907777|NCT00601458|FG002|Participant Flow|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
10907778|NCT00601458|OG000|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
10907779|NCT00601458|OG001|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
10907780|NCT00601458|OG002|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
10907781|NCT00601458|EG000|Reported Event|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
10907782|NCT00601458|EG001|Reported Event|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
10907783|NCT00601458|EG002|Reported Event|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
10907784|NCT00601484|BG000|Baseline|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
10907785|NCT00601484|BG001|Baseline|Placebo|A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
10907786|NCT00601484|BG002|Baseline|Total|Total of all reporting groups
10907787|NCT00601484|FG000|Participant Flow|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
10907788|NCT00601484|FG001|Participant Flow|Placebo|A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
10907789|NCT00601484|OG000|Outcome|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
10907790|NCT00601484|OG001|Outcome|Placebo|A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
10907791|NCT00601484|EG000|Reported Event|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
10907792|NCT00601484|EG001|Reported Event|Placebo|A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
10907793|NCT00601523|BG000|Baseline|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
10907794|NCT00601523|BG001|Baseline|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
10907795|NCT00601523|BG002|Baseline|Total|Total of all reporting groups
10907796|NCT00601523|FG000|Participant Flow|Patients From 248.524|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.524 (NCT00479401) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
10907797|NCT00601523|FG001|Participant Flow|Patients From 248.636|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.636 (NCT00558025) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
10907798|NCT00601523|OG000|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
10907799|NCT00601523|OG001|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
10907800|NCT00601523|EG000|Reported Event|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
10907801|NCT00601523|EG001|Reported Event|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
10907802|NCT00601627|BG000|Baseline|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
10907803|NCT00601627|FG000|Participant Flow|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
10907804|NCT00601627|OG000|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
10907805|NCT00601627|EG000|Reported Event|Panitumumab|6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
10907806|NCT00601640|BG000|Baseline|Arm I|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
10907807|NCT00601640|BG001|Baseline|Arm II|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
10907808|NCT00601640|BG002|Baseline|Arm III|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
10907809|NCT00601640|BG003|Baseline|Total|Total of all reporting groups
10907810|NCT00601640|FG000|Participant Flow|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
11091145|NCT01533116|OG003|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
10907811|NCT00601640|FG001|Participant Flow|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
10907812|NCT00601640|FG002|Participant Flow|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
10907813|NCT00601640|OG000|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
10907814|NCT00601640|OG001|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
10907815|NCT00601640|OG002|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
10907816|NCT00601640|OG000|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90
10907817|NCT00601640|OG002|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90
10907818|NCT00601640|EG000|Reported Event|Arm I|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
10907819|NCT00601640|EG001|Reported Event|Arm II|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
10907820|NCT00601640|EG002|Reported Event|Arm III|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
10907821|NCT00601705|BG000|Baseline|Epirubicin, Oxaliplatin, 5-fluorouracil, and Surgery|Subjects received epirubicin (50-mg/m^2), oxaliplatin (130-mg/m^2), 5-fluorouracil (5FU; 200mg/m^2/d), and surgery, which took place 4 to 5 weeks after the completion of preoperative chemotherapy. Epirubicin and oxaliplatin were given on day 1, while 5FU was intravenously infused for 21-days. Surgery was conducted 4 to 5-weeks after chemotherapy. Six to ten-weeks after surgery chemoradiotherapy was initiated. With radiotherapy, patients received two cycles of cisplatin and 5FU during the first and fourth weeks after surgery; they were administered intravenously over 96-hours. Specifically, cisplatin and 5FU total dose was 80-mg/m^2 (20-mg/m^2/d) and 4000 mg/m^2 (1000-mg/m^2/d), respectively.
10907822|NCT00601705|FG000|Participant Flow|Epirubicin, Oxaliplatin, 5-fluorouracil, and Surgery|Subjects received epirubicin (50-mg/m^2), oxaliplatin (130-mg/m^2), 5-fluorouracil (5FU; 200mg/m^2/d), and surgery, which took place 4 to 5 weeks after the completion of preoperative chemotherapy. Epirubicin and oxaliplatin were given on day 1, while 5FU was intravenously infused for 21-days. Surgery was conducted 4 to 5-weeks after chemotherapy. Six to ten-weeks after surgery chemoradiotherapy was initiated. With radiotherapy, patients received two cycles of cisplatin and 5FU during the first and fourth weeks after surgery; they were administered intravenously over 96-hours. Specifically, cisplatin and 5FU total dose was 80-mg/m^2 (20-mg/m^2/d) and 4000 mg/m^2 (1000-mg/m^2/d), respectively.
10907823|NCT00601705|OG000|Outcome|Epirubicin, Oxaliplatin, 5-fluorouracil, and Surgery|Subjects received epirubicin (50-mg/m^2), oxaliplatin (130-mg/m^2), 5-fluorouracil (5FU; 200mg/m^2/d), and surgery, which took place 4 to 5 weeks after the completion of preoperative chemotherapy. Epirubicin and oxaliplatin were given on day 1, while 5FU was intravenously infused for 21-days. Surgery was conducted 4 to 5-weeks after chemotherapy. Six to ten-weeks after surgery chemoradiotherapy was initiated. With radiotherapy, patients received two cycles of cisplatin and 5FU during the first and fourth weeks after surgery; they were administered intravenously over 96-hours. Specifically, cisplatin and 5FU total dose was 80-mg/m^2 (20-mg/m^2/d) and 4000 mg/m^2 (1000-mg/m^2/d), respectively.
10907824|NCT00601705|OG000|Outcome|Epirubicin, Oxaliplatin and Fluorouracil|Epirubicin, Oxaliplatin and Fluorouracil (EOF) followed by Esophagogastrectomy and post-operative concurrent chemoradiotherapy with Fluorouracil and Cisplatin
10907825|NCT00601705|EG000|Reported Event|Epirubicin, Oxaliplatin and Fluorouracil|"cisplatin: 20 mg/m2/day IV continuous infusion over 24 hours for 96 hours.~epirubicin hydrochloride: 50 mg/m2 IV bolus~fluorouracil: 200 mg/m2/day continuous infusion for all 9 weeks, beginning on day 1.~oxaliplatin: 130 mg/m2 IV infusion over 2 hours~adjuvant therapy: At 6-10 weeks after surgery patients will begin postoperative chemoradiotherapy. Daily radiation therapy fractions of 180-200 cGy will be given. Concurrent with this radiation, two cycles of chemotherapy will be given, during the first and fourth weeks of the radiation~neoadjuvant therapy: Three weeks after discontinuing the fluorouracil patients will be fully restaged to assess for a clinical response, and to ensure that there is no contraindication to surgical resection, which will be scheduled for app"
10907826|NCT00601718|BG000|Baseline|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
10907827|NCT00601718|FG000|Participant Flow|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
10907828|NCT00601718|OG000|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
10907829|NCT00601718|EG000|Reported Event|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
10907830|NCT00601731|BG000|Baseline|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907831|NCT00601731|BG001|Baseline|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907832|NCT00601731|BG002|Baseline|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907833|NCT00601731|BG003|Baseline|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
10907834|NCT00601731|BG004|Baseline|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
10907835|NCT00601731|BG005|Baseline|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
10907836|NCT00601731|BG006|Baseline|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
10907837|NCT00601731|BG007|Baseline|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907838|NCT00601731|BG008|Baseline|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
11172658|NCT02010645|OG000|Outcome|Eltrombopag + Decitabine|"Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.~Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.~Eltrombopag: Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.~Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle."
11172659|NCT02010645|EG000|Reported Event|Eltrombopag + Decitabine|"Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.~Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.~Eltrombopag: Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.~Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle."
11172660|NCT02010684|BG000|Baseline|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
11172661|NCT02010684|BG001|Baseline|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants will learn a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
11172662|NCT02010684|BG002|Baseline|Total|Total of all reporting groups
11172663|NCT02010684|FG000|Participant Flow|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
11172664|NCT02010684|FG001|Participant Flow|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. Then participants will learn a diabetes education format grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. Group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.~Empowerment and CBT Classes: Participants will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers Understanding Depression and Diabetes, Module 2 How Thoughts Affect Your Mood and Diabetes Care, Module 3 How Activities Affect Your Mood and Diabetes Care. The Diabetes Empowerment Modu"
11174228|NCT02020369|EG001|Reported Event|Coagulation Factor VIIa (Recombinant): 225 µg/kg|"Coagulation Factor VIIa (Recombinant) : 225 µg/kg for 3 months~Coagulation Factor VIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX"
11233420|NCT02427646|EG001|Reported Event|Parkinson Disease Tremor Treatment|IncobotulinumtoxinA: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
11233421|NCT02427672|BG000|Baseline|Anodal Stimulation|"Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the dorsolateral prefrontal cortex bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 1mA will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.~Transcranial direct current stimulation"
11233422|NCT02427672|BG001|Baseline|Sham Stimulation|"The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.~Sham transcranial direct current stimulation"
11233423|NCT02427672|BG002|Baseline|Total|Total of all reporting groups
11233424|NCT02427672|FG000|Participant Flow|Anodal Stimulation|"Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the dorsolateral prefrontal cortex bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 1mA will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.~Transcranial direct current stimulation"
11233425|NCT02427672|FG001|Participant Flow|Sham Stimulation|"The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.~Sham transcranial direct current stimulation"
11233426|NCT02427672|OG000|Outcome|Anodal Stimulation|"Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the dorsolateral prefrontal cortex bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 1mA will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.~Transcranial direct current stimulation"
11233427|NCT02427672|OG001|Outcome|Sham Stimulation|"The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.~Sham transcranial direct current stimulation"
11233428|NCT02427672|EG000|Reported Event|Anodal Stimulation|"Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the dorsolateral prefrontal cortex bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 1mA will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.~Transcranial direct current stimulation"
11233429|NCT02427672|EG001|Reported Event|Sham Stimulation|"The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.~Sham transcranial direct current stimulation"
11233430|NCT02427737|BG000|Baseline|Comfort Talk® Training OSU|"Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the study.~Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11233431|NCT02427737|BG001|Baseline|Control OSU|Three MRI sites at OSU were not trained in Comfort Talk®.
11233432|NCT02427737|BG002|Baseline|Total|Total of all reporting groups
11233433|NCT02427737|FG000|Participant Flow|Comfort Talk® Training|"MRI clinical sites form the experimental group. Their personnel is trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the study.~Comfort Talk® Training: Personnel of MRI units is trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
10907839|NCT00601731|BG009|Baseline|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
10907840|NCT00601731|BG010|Baseline|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
10907841|NCT00601731|BG011|Baseline|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
10907842|NCT00601731|BG012|Baseline|Total|Total of all reporting groups
10907843|NCT00601731|FG000|Participant Flow|UK Site|UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.
10907844|NCT00601731|FG001|Participant Flow|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
10907845|NCT00601731|FG002|Participant Flow|Canada Sites|Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.
10907846|NCT00601731|FG003|Participant Flow|Canada Control|Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
10907847|NCT00601731|OG000|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907848|NCT00601731|OG001|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907849|NCT00601731|OG002|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907850|NCT00601731|OG003|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
10907851|NCT00601731|OG004|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
10907852|NCT00601731|OG005|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
10907853|NCT00601731|OG006|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
10907854|NCT00601731|OG007|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907855|NCT00601731|OG008|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
10907856|NCT00601731|OG009|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
10907857|NCT00601731|OG010|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
10907858|NCT00601731|OG011|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
10907859|NCT00601731|EG000|Reported Event|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907860|NCT00601731|EG001|Reported Event|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907861|NCT00601731|EG002|Reported Event|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907862|NCT00601731|EG003|Reported Event|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
10907863|NCT00601731|EG004|Reported Event|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
10907864|NCT00601731|EG005|Reported Event|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
11091146|NCT01533116|EG000|Reported Event|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
11233434|NCT02427737|FG001|Participant Flow|Control|"MRI sites are not be trained in Comfort Talk®.~Please note that at OSU both trained and control sites had a baseline and three post-training periods.~At Duke, the data in the initial baseline period became the control data in a pre to post comparison for reasons explained above. Therefore Duke has only 2 time periods with the initial Baseline entered as Control."
11233435|NCT02427737|OG000|Outcome|Comfort Talk® Training|"In the experimental group, MRI personnel is trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the MRI scan.~Comfort Talk® Training: Personnel of MRI units is trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11233436|NCT02427737|OG001|Outcome|Control|MRI sites not trained in Comfort Talk®.
11233437|NCT02427737|OG000|Outcome|Comfort Talk® Training OSU|"Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the study.~Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11233438|NCT02427737|OG001|Outcome|Control OSU|Three MRI sites at OSU were not trained in Comfort Talk®.
11233439|NCT02427737|OG000|Outcome|Baseline (Duke)|Patients who show for their MRI scans prior to team Training in Comfort Talk®
11233440|NCT02427737|OG001|Outcome|Post Comfort Talk® Training|Patient who show for their MRI scans after team training in Comfort Talk®
11233441|NCT02427737|OG000|Outcome|Comfort Talk® Training|"MRI clinical sites form the experimental group. Their personnel is trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the study.~Comfort Talk® Training: Personnel of MRI units is trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11233442|NCT02427737|OG001|Outcome|Control|"MRI sites are not be trained in Comfort Talk®.~Please note that at OSU both trained and control sites had a baseline and three post-training periods.~At Duke, the data in the initial baseline period became the control data in a pre to post comparison for reasons explained above. Therefore Duke has only 2 time period with the initial Baseline entered as Control."
11233443|NCT02427737|EG000|Reported Event|Comfort Talk® Training (OSU)|"Three MRI clinical sites form the experimental group. Their personnel was trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the study.~Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11233444|NCT02427737|EG001|Reported Event|Control (OSU)|Three MRI sites were not trained in Comfort Talk®.
11233445|NCT02427737|EG002|Reported Event|Baseline = Control (Duke)|Data from 6 Duke sites at baseline were used as the control in a pre- to post-training comparison
11233446|NCT02427737|EG003|Reported Event|Comfort Talk® Training (Duke)|The same 6 Duke sites represented at baseline formed the experimental group after Comfort Talk training in a pre- to post- training comparison
11233447|NCT02427750|BG000|Baseline|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
11233448|NCT02427750|BG001|Baseline|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
11091147|NCT01533116|EG001|Reported Event|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
11233449|NCT02427750|BG002|Baseline|Total|Total of all reporting groups
11233450|NCT02427750|FG000|Participant Flow|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
11233451|NCT02427750|FG001|Participant Flow|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
11233452|NCT02427750|OG000|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
11233453|NCT02427750|OG001|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
11233454|NCT02427750|EG000|Reported Event|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
11233455|NCT02427750|EG001|Reported Event|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
11233456|NCT02427750|EG002|Reported Event|Total|
11233457|NCT02427802|BG000|Baseline|Gentamicin Sponge Group|"Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11233458|NCT02427802|BG001|Baseline|Placebo Sponge Group|"Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Placebo: Matching collagen sponge"
11233459|NCT02427802|BG002|Baseline|No Sponge Group|Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
11233460|NCT02427802|BG003|Baseline|Total|Total of all reporting groups
11233461|NCT02427802|FG000|Participant Flow|Gentamicin Sponge Group|"Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11233462|NCT02427802|FG001|Participant Flow|Placebo Sponge Group|"Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Placebo: Matching collagen sponge"
11233463|NCT02427802|FG002|Participant Flow|No Sponge Group|Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
11233464|NCT02427802|OG000|Outcome|Gentamicin Sponge Group|"Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11233465|NCT02427802|OG001|Outcome|Placebo Sponge Group|"Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Placebo: Matching collagen sponge"
11233466|NCT02427802|OG002|Outcome|No Sponge Group|Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
11233467|NCT02427802|EG000|Reported Event|Gentamicin Sponge Group|"Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11233468|NCT02427802|EG001|Reported Event|Placebo Sponge Group|"Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Placebo: Matching collagen sponge"
11233469|NCT02427802|EG002|Reported Event|No Sponge Group|Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
11233470|NCT02427841|BG000|Baseline|Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)|"PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks.~SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation.~POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity.~Fluorouracil: Given IV~Gemcitabine: Given IV~Image Guided Radiation Therapy: Undergo IG-IMRT~Intensity-Modulated Radiation Therapy: Undergo IG-IMRT~Laboratory Biomarker Analysis: Correlative studies~Nab-paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
10907865|NCT00601731|EG006|Reported Event|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
11233471|NCT02427841|FG000|Participant Flow|Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)|"PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks.~SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation.~POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity.~Fluorouracil: Given IV~Gemcitabine: Given IV~Image Guided Radiation Therapy: Undergo IG-IMRT~Intensity-Modulated Radiation Therapy: Undergo IG-IMRT~Laboratory Biomarker Analysis: Correlative studies~Nab-paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
11335640|NCT03554018|EG000|Reported Event|Acetaminophen|"Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.~Acetaminophen: Acetaminophen 500-1000mg every 6 hours~Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10907866|NCT00601731|EG007|Reported Event|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
10907867|NCT00601731|EG008|Reported Event|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
10907868|NCT00601731|EG009|Reported Event|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
10907869|NCT00601731|EG010|Reported Event|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
10907870|NCT00601731|EG011|Reported Event|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
10907871|NCT00601796|BG000|Baseline|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
10907872|NCT00601796|FG000|Participant Flow|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
10907873|NCT00601796|OG000|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
10907874|NCT00601796|EG000|Reported Event|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
10907875|NCT00601835|BG000|Baseline|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
10907876|NCT00601835|BG001|Baseline|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
10907877|NCT00601835|BG002|Baseline|Total|Total of all reporting groups
10907878|NCT00601835|FG000|Participant Flow|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
10907879|NCT00601835|FG001|Participant Flow|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
11172665|NCT02010684|OG000|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
10907880|NCT00601835|OG000|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
10907881|NCT00601835|OG001|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
10907882|NCT00601835|EG000|Reported Event|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
10907883|NCT00601835|EG001|Reported Event|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
10907884|NCT00601926|BG000|Baseline|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
10907885|NCT00601926|FG000|Participant Flow|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
10907886|NCT00601926|OG000|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
11172666|NCT02010684|OG001|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
10907887|NCT00601926|EG000|Reported Event|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
10907888|NCT00601952|BG000|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
10907889|NCT00601952|BG001|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
10907890|NCT00601952|BG002|Baseline|Total|Total of all reporting groups
10907891|NCT00601952|FG000|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
10907892|NCT00601952|FG001|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
10907893|NCT00601952|OG000|Outcome|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
10907894|NCT00601952|OG001|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
10907895|NCT00601952|EG000|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
10907896|NCT00601952|EG001|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
11172667|NCT02010684|EG000|Reported Event|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
10907897|NCT00601965|BG000|Baseline|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
10907898|NCT00601965|BG001|Baseline|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
10907899|NCT00601965|BG002|Baseline|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
10907900|NCT00601965|BG003|Baseline|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
10907901|NCT00601965|BG004|Baseline|Total|Total of all reporting groups
10907902|NCT00601965|FG000|Participant Flow|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
10907903|NCT00601965|FG001|Participant Flow|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
10907904|NCT00601965|FG002|Participant Flow|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
10907905|NCT00601965|FG003|Participant Flow|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
10907906|NCT00601965|OG000|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
10907907|NCT00601965|OG001|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
10907908|NCT00601965|OG002|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
10907909|NCT00601965|OG003|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
10907910|NCT00601965|EG000|Reported Event|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
10907911|NCT00601965|EG001|Reported Event|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
10907912|NCT00601965|EG002|Reported Event|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
10907913|NCT00601965|EG003|Reported Event|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
10907914|NCT00602043|BG000|Baseline|First Line Endocrine Therapy for a Stage IV Disease|
10907915|NCT00602043|FG000|Participant Flow|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
11342168|NCT03699124|EG002|Reported Event|GP 3: Two Doses of FD MVA-BN--Lot 3|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
10907916|NCT00602043|OG000|Outcome|Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.~laboratory biomarker analysis: Correlative studies"
10907917|NCT00602043|OG001|Outcome|Diagnostic FES: Patients With FES Negative Sites of Disease|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan."
10907918|NCT00602043|OG000|Outcome|Diagnostic (FES): Average FES SUVmean >1.5, no Negative Sites|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan."
10907919|NCT00602043|OG000|Outcome|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
10907920|NCT00602043|EG000|Reported Event|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
10907921|NCT00602225|BG000|Baseline|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
10907922|NCT00602225|FG000|Participant Flow|Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
10907923|NCT00602225|OG000|Outcome|Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
10907924|NCT00602225|OG000|Outcome|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
10907925|NCT00602225|EG000|Reported Event|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
10907926|NCT00602290|BG000|Baseline|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
10907927|NCT00602290|BG001|Baseline|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
10907928|NCT00602290|BG002|Baseline|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
10907929|NCT00602290|BG003|Baseline|Total|Total of all reporting groups
10907930|NCT00602290|FG000|Participant Flow|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
10907931|NCT00602290|FG001|Participant Flow|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
10907932|NCT00602290|FG002|Participant Flow|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
10907933|NCT00602290|OG000|Outcome|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
10907934|NCT00602290|OG001|Outcome|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
10907935|NCT00602290|OG002|Outcome|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
10907936|NCT00602290|EG000|Reported Event|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
10907937|NCT00602290|EG001|Reported Event|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
10907938|NCT00602290|EG002|Reported Event|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
10907939|NCT00602355|BG000|Baseline|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific mother-crafting techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
10907940|NCT00602355|BG001|Baseline|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific mother-crafting techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
10907941|NCT00602355|BG002|Baseline|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
10907942|NCT00602355|BG003|Baseline|Total|Total of all reporting groups
10907943|NCT00602355|FG000|Participant Flow|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific mother-crafting techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
10907944|NCT00602355|FG001|Participant Flow|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific mother-crafting techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
10907945|NCT00602355|FG002|Participant Flow|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
10907946|NCT00602355|OG000|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific mother-crafting techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
11091148|NCT01533116|EG002|Reported Event|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
10907947|NCT00602355|OG001|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific mother-crafting techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
10907948|NCT00602355|OG002|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
10907949|NCT00602355|EG000|Reported Event|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific mother-crafting techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
10907950|NCT00602355|EG001|Reported Event|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific mother-crafting techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
10907951|NCT00602355|EG002|Reported Event|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
10907952|NCT00602420|BG000|Baseline|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
10907953|NCT00602420|BG001|Baseline|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
10907954|NCT00602420|BG002|Baseline|Total|Total of all reporting groups
10907955|NCT00602420|FG000|Participant Flow|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
10907956|NCT00602420|FG001|Participant Flow|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
10907957|NCT00602420|OG000|Outcome|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
10907958|NCT00602420|OG001|Outcome|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
10907959|NCT00602420|EG000|Reported Event|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
10907960|NCT00602420|EG001|Reported Event|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
10907961|NCT00602446|BG000|Baseline|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
10907962|NCT00602446|FG000|Participant Flow|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
10907963|NCT00602446|OG000|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
10907964|NCT00602446|EG000|Reported Event|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
10907965|NCT00602472|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
10907966|NCT00602472|BG001|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
10907967|NCT00602472|BG002|Baseline|Total|Total of all reporting groups
10907968|NCT00602472|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
10907969|NCT00602472|FG001|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
10907970|NCT00602472|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
10907971|NCT00602472|OG001|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
10907972|NCT00602472|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
10907973|NCT00602472|EG001|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
10915105|NCT00634088|BG002|Baseline|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg), lapatinib 1250 mg administered orally once a day, every day for 7 to 14 consecutive days prior to the first administration of ixabepilone in Cycle 1. Then lapatinib administered daily, orally once a day, for a 21-day cycle. Ixabepilone administered as a 3-hour IV infusion of 40 mg/m^2 following lapatinib lead-in period.
10907974|NCT00602537|BG000|Baseline|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
10907975|NCT00602537|BG001|Baseline|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
11172668|NCT02010684|EG001|Reported Event|Empowerment and CBT Classes|"Weekly 2-hour group Empowerment and CBT classes for 12 weeks are led by two trained health educators. Cognitive behavioral therapy (CBT) techniques to manage mood and diabetes education, grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood, is presented. Group members monitor their blood sugar levels, blood pressure, and mood on a daily basis. The intervention arm participants receive a manual with 3 CBT modules (Understanding Depression and Diabetes, How Thoughts Affect Your Mood and Diabetes Care, andHow Activities Affect Your Mood and Diabetes Care. and 1 Diabetes Empowerment module. covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources."
11172669|NCT02010697|BG000|Baseline|Messages Targeting Nonsmokers|"Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.~Messages targeting nonsmokers"
11172670|NCT02010697|BG001|Baseline|Messages Targeting Smokers|"Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.~Messages targeting smokers"
11172671|NCT02010697|BG002|Baseline|Usual Care|one time mailing with a self-help quit kit
11172672|NCT02010697|BG003|Baseline|Total|Total of all reporting groups
11172673|NCT02010697|FG000|Participant Flow|Messages Targeting Nonsmokers|"Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.~Messages targeting nonsmokers"
11172674|NCT02010697|FG001|Participant Flow|Messages Targeting Smokers|"Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.~Messages targeting smokers"
11172675|NCT02010697|FG002|Participant Flow|Usual Care|one time mailing with a self-help quit kit
11172676|NCT02010697|OG000|Outcome|Messages Targeting Nonsmokers|"Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.~Messages targeting nonsmokers"
11172677|NCT02010697|OG001|Outcome|Messages Targeting Smokers|"Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.~Messages targeting smokers"
11172678|NCT02010697|OG002|Outcome|Usual Care|one time mailing with a self-help quit kit
11172679|NCT02010697|EG000|Reported Event|Messages Targeting Nonsmokers|"Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.~Messages targeting nonsmokers"
11172680|NCT02010697|EG001|Reported Event|Messages Targeting Smokers|"Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.~Messages targeting smokers"
10907976|NCT00602537|BG002|Baseline|Total|Total of all reporting groups
10907977|NCT00602537|FG000|Participant Flow|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
10907978|NCT00602537|FG001|Participant Flow|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
10907979|NCT00602537|OG000|Outcome|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
10907980|NCT00602537|OG001|Outcome|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
10907981|NCT00602537|EG000|Reported Event|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
10907982|NCT00602537|EG001|Reported Event|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
10907983|NCT00602771|BG000|Baseline|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
11172681|NCT02010697|EG002|Reported Event|Usual Care|one time mailing with a self-help quit kit
11172682|NCT02010775|BG000|Baseline|BOTOX® 96U|Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172683|NCT02010775|BG001|Baseline|BOTOX® 72U|Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172684|NCT02010775|BG002|Baseline|BOTOX® 48U|Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
10907984|NCT00602771|BG001|Baseline|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
10907985|NCT00602771|BG002|Baseline|Total|Total of all reporting groups
10907986|NCT00602771|FG000|Participant Flow|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
10907987|NCT00602771|FG001|Participant Flow|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
10907988|NCT00602771|OG000|Outcome|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
10907989|NCT00602771|OG001|Outcome|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
10907990|NCT00602771|EG000|Reported Event|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
10907991|NCT00602771|EG001|Reported Event|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
10907992|NCT00602797|BG000|Baseline|Treatment (Vinorelbine Tartrate, Paclitaxel)|"Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Vinorelbine Tartrate: Given IV"
10907993|NCT00602797|FG000|Participant Flow|Treatment|This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L).
10907994|NCT00602797|OG000|Outcome|Treatment Group|Patients >70 years with advanced NSCLC treated with weekly paclitaxel and vinorelbine
11172685|NCT02010775|BG003|Baseline|BOTOX® 24U|Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172686|NCT02010775|BG004|Baseline|Placebo|Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172687|NCT02010775|BG005|Baseline|Total|Total of all reporting groups
11172688|NCT02010775|FG000|Participant Flow|BOTOX® 96U|Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172689|NCT02010775|FG001|Participant Flow|BOTOX® 72U|Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172690|NCT02010775|FG002|Participant Flow|BOTOX® 48U|Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172691|NCT02010775|FG003|Participant Flow|BOTOX® 24U|Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172692|NCT02010775|FG004|Participant Flow|Placebo|Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172693|NCT02010775|OG000|Outcome|BOTOX® 96U|Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172694|NCT02010775|OG001|Outcome|BOTOX® 72U|Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172695|NCT02010775|OG002|Outcome|BOTOX® 48U|Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172696|NCT02010775|OG003|Outcome|BOTOX® 24U|Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172697|NCT02010775|OG004|Outcome|Placebo|Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172698|NCT02010775|EG000|Reported Event|BOTOX® 96U|Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172699|NCT02010775|EG001|Reported Event|BOTOX® 72U|Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172700|NCT02010775|EG002|Reported Event|BOTOX® 48U|Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172701|NCT02010775|EG003|Reported Event|BOTOX® 24U|Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
11172702|NCT02010775|EG004|Reported Event|Placebo|Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
10907995|NCT00602797|OG000|Outcome|Treatment|This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L).
10907996|NCT00602797|EG000|Reported Event|Treatment (Vinorelbine Tartrate, Paclitaxel)|"Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Vinorelbine Tartrate: Given IV"
10907997|NCT00602836|BG000|Baseline|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
10907998|NCT00602836|FG000|Participant Flow|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
10907999|NCT00602836|OG000|Outcome|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
10908000|NCT00602836|EG000|Reported Event|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
10908001|NCT00602927|BG000|Baseline|Placebo First, Then Varenicline|Days 1 - 3: 0.5 mg once a day orally Days 4 - 7: 0.5 mg twice a day orally Days 8 - 13: 1 mg twice a day orally
10908002|NCT00602927|BG001|Baseline|Varenicline First, Then Placebo|Days 1 - 3: 0.5 mg once a day orally Days 4 - 7: 0.5 mg twice a day orally Days 8 - 13: 1 mg twice a day orally
10908003|NCT00602927|BG002|Baseline|Total|Total of all reporting groups
10908004|NCT00602927|FG000|Participant Flow|Placebo First, Then Varenicline|Days 1 - 3: 0.5 mg once a day orally Days 4 - 7: 0.5 mg twice a day orally Days 8 - 13: 1 mg twice a day orally
10908005|NCT00602927|FG001|Participant Flow|Varenicline First, Then Placebo|Days 1 - 3: 0.5 mg once a day orally Days 4 - 7: 0.5 mg twice a day orally Days 8 - 13: 1 mg twice a day orally
10908006|NCT00602927|OG000|Outcome|Placebo|Days 1 - 3: 0.5 mg once a day orally Days 4 - 7: 0.5 mg twice a day orally Days 8 - 13: 1 mg twice a day orally
10908007|NCT00602927|OG001|Outcome|Varenicline|Days 1 - 3: 0.5 mg once a day orally Days 4 - 7: 0.5 mg twice a day orally Days 8 - 13: 1 mg twice a day orally
10908008|NCT00602927|EG000|Reported Event|Placebo First, Then Varenicline|Days 1 - 3: 0.5 mg once a day orally Days 4 - 7: 0.5 mg twice a day orally Days 8 - 13: 1 mg twice a day orally
11342169|NCT03700320|BG000|Baseline|Oral SOC Migraine Preventive Medication|Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
10908009|NCT00602927|EG001|Reported Event|Varenicline First, Then Placebo|Days 1 - 3: 0.5 mg once a day orally Days 4 - 7: 0.5 mg twice a day orally Days 8 - 13: 1 mg twice a day orally
10908010|NCT00602953|BG000|Baseline|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908011|NCT00602953|BG001|Baseline|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908012|NCT00602953|BG002|Baseline|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
11342170|NCT03700320|BG001|Baseline|Atogepant 60 mg|Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
10908013|NCT00602953|BG003|Baseline|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908014|NCT00602953|BG004|Baseline|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908015|NCT00602953|BG005|Baseline|Total|Total of all reporting groups
10908016|NCT00602953|FG000|Participant Flow|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908017|NCT00602953|FG001|Participant Flow|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908018|NCT00602953|FG002|Participant Flow|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908019|NCT00602953|FG003|Participant Flow|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908020|NCT00602953|FG004|Participant Flow|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908021|NCT00602953|OG000|Outcome|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908022|NCT00602953|OG001|Outcome|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908023|NCT00602953|OG002|Outcome|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908024|NCT00602953|OG003|Outcome|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908025|NCT00602953|OG004|Outcome|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908026|NCT00602953|EG000|Reported Event|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908027|NCT00602953|EG001|Reported Event|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
11342171|NCT03700320|BG002|Baseline|Total|Total of all reporting groups
10908028|NCT00602953|EG002|Reported Event|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908029|NCT00602953|EG003|Reported Event|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908030|NCT00602953|EG004|Reported Event|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
10908031|NCT00602979|BG000|Baseline|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
10908032|NCT00602979|BG001|Baseline|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
10908033|NCT00602979|BG002|Baseline|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
10908034|NCT00602979|BG003|Baseline|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
10908035|NCT00602979|BG004|Baseline|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
10908036|NCT00602979|BG005|Baseline|Total|Total of all reporting groups
11172703|NCT02010996|BG000|Baseline|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
10908037|NCT00602979|FG000|Participant Flow|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
10908038|NCT00602979|FG001|Participant Flow|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
10908039|NCT00602979|FG002|Participant Flow|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
10908040|NCT00602979|FG003|Participant Flow|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
10908041|NCT00602979|FG004|Participant Flow|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
10908042|NCT00602979|OG000|Outcome|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
10908043|NCT00602979|OG001|Outcome|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
10908044|NCT00602979|OG002|Outcome|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
10908045|NCT00602979|OG003|Outcome|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
10908046|NCT00602979|OG004|Outcome|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
10908047|NCT00602979|EG000|Reported Event|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
10908048|NCT00602979|EG001|Reported Event|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
10908049|NCT00602979|EG002|Reported Event|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
10908050|NCT00602979|EG003|Reported Event|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
10908051|NCT00602979|EG004|Reported Event|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
10908052|NCT00603018|BG000|Baseline|1/Recovered Anorevia|"Recovered anorexia~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
10908053|NCT00603018|FG000|Participant Flow|Participants Recovered From Anorexia Before + After Fluoxetine|"Participants recovered from anorexia~Fluoxetine: before 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
10908054|NCT00603018|OG000|Outcome|1/Recovered Anorexia Before 8 Weeks of Treatment|"1/Recovered anorexia before 8 weeks of treatment~Baseline"
10908055|NCT00603018|OG001|Outcome|1/Recovered Anorexia After 8 Weeks of Treatment|"1/Recovered anorexia after 8 weeks of treatment~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
10908056|NCT00603018|EG000|Reported Event|1/Recovered Anorexia|"Recovered anorexia~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
11174229|NCT02020408|BG000|Baseline|[11C]Raclopride, [11C]DASB, Amphetamine|"healthy control women (CW);~women recovered from restricting type anorexia nervosa (REC AN);~women recovered from bulimic type anorexia nervosa (REC AN-BN)~women recovered from from bulimia nervosa (REC BN)"
10908057|NCT00603044|BG000|Baseline|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
10908058|NCT00603044|BG001|Baseline|No Treatment|Subjects in this arm received no treatment.
10908059|NCT00603044|BG002|Baseline|Total|Total of all reporting groups
10908060|NCT00603044|FG000|Participant Flow|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
10908061|NCT00603044|FG001|Participant Flow|No Treatment|Subjects in this arm received no treatment.
10908062|NCT00603044|OG000|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
10908063|NCT00603044|OG001|Outcome|No Treatment|Subjects in this arm received no treatment.
10908064|NCT00603044|EG000|Reported Event|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
10908065|NCT00603044|EG001|Reported Event|No Treatment|Subjects in this arm received no treatment.
10908066|NCT00603187|BG000|Baseline|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
10908067|NCT00603187|FG000|Participant Flow|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
10908068|NCT00603187|OG000|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
10908069|NCT00603187|EG000|Reported Event|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
10908070|NCT00603239|BG000|Baseline|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
10908071|NCT00603239|BG001|Baseline|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
10908072|NCT00603239|BG002|Baseline|Total|Total of all reporting groups
10908073|NCT00603239|FG000|Participant Flow|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
10908074|NCT00603239|FG001|Participant Flow|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
10908075|NCT00603239|OG000|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
10908076|NCT00603239|OG001|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
10908077|NCT00603239|EG000|Reported Event|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
10908078|NCT00603239|EG001|Reported Event|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
10908079|NCT00603265|BG000|Baseline|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
10908080|NCT00603265|BG001|Baseline|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
10908081|NCT00603265|BG002|Baseline|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
10908082|NCT00603265|BG003|Baseline|Total|Total of all reporting groups
10908083|NCT00603265|FG000|Participant Flow|ADL5859|2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
10908084|NCT00603265|FG001|Participant Flow|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
10908085|NCT00603265|FG002|Participant Flow|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
10908086|NCT00603265|OG000|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
10908087|NCT00603265|OG001|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
10908088|NCT00603265|OG002|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
10908089|NCT00603265|EG000|Reported Event|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
10908090|NCT00603265|EG001|Reported Event|Duloxetine|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
10908091|NCT00603265|EG002|Reported Event|Placebo|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
10908092|NCT00603278|BG000|Baseline|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
10908093|NCT00603278|BG001|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908094|NCT00603278|BG002|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908095|NCT00603278|BG003|Baseline|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908096|NCT00603278|BG004|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908097|NCT00603278|BG005|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908098|NCT00603278|BG006|Baseline|Total|Total of all reporting groups
10908099|NCT00603278|FG000|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
10908100|NCT00603278|FG001|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908101|NCT00603278|FG002|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908102|NCT00603278|FG003|Participant Flow|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908103|NCT00603278|FG004|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908104|NCT00603278|FG005|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908105|NCT00603278|OG000|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
10908106|NCT00603278|OG001|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908107|NCT00603278|OG002|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908108|NCT00603278|OG003|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908109|NCT00603278|OG004|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908110|NCT00603278|OG005|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908111|NCT00603278|EG000|Reported Event|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
10908112|NCT00603278|EG001|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908113|NCT00603278|EG002|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10915106|NCT00634088|BG003|Baseline|Ixabepilone + Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
10908114|NCT00603278|EG003|Reported Event|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908115|NCT00603278|EG004|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908116|NCT00603278|EG005|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908117|NCT00603291|BG000|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
10908118|NCT00603291|BG001|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10908119|NCT00603291|BG002|Baseline|Matching Placebo|matching placebo tablets
10908120|NCT00603291|BG003|Baseline|Total|Total of all reporting groups
10908121|NCT00603291|FG000|Participant Flow|Lorcaserin 10 mg Once Daily (QD)|lorcaserin 10 mg QD tablets
10908122|NCT00603291|FG001|Participant Flow|Lorcaserin 10 mg Twice a Day (BID)|lorcaserin 10 mg BID tablets
10908123|NCT00603291|FG002|Participant Flow|Matching Placebo|matching placebo tablets
10908124|NCT00603291|OG000|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10908125|NCT00603291|OG001|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
10908126|NCT00603291|OG002|Outcome|Matching Placebo|matching placebo tablets
10908127|NCT00603291|EG000|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10908128|NCT00603291|EG001|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
10908129|NCT00603291|EG002|Reported Event|Matching Placebo|matching placebo tablets
10908130|NCT00603304|BG000|Baseline|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
10908131|NCT00603304|BG001|Baseline|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
10908132|NCT00603304|BG002|Baseline|Total|Total of all reporting groups
10908133|NCT00603304|FG000|Participant Flow|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
10908134|NCT00603304|FG001|Participant Flow|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
10908135|NCT00603304|OG000|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
10908136|NCT00603304|OG001|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
10908137|NCT00603304|OG000|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
10908138|NCT00603304|OG001|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
10908139|NCT00603304|EG000|Reported Event|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
10908140|NCT00603304|EG001|Reported Event|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
10908141|NCT00603382|BG000|Baseline|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
10908142|NCT00603382|BG001|Baseline|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908143|NCT00603382|BG002|Baseline|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908144|NCT00603382|BG003|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908145|NCT00603382|BG004|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908146|NCT00603382|BG005|Baseline|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908147|NCT00603382|BG006|Baseline|Total|Total of all reporting groups
10908148|NCT00603382|FG000|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
10915107|NCT00634088|BG004|Baseline|Total|Total of all reporting groups
10908149|NCT00603382|FG001|Participant Flow|GW685698X 25 µg OD|Participants received GW685698X 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908150|NCT00603382|FG002|Participant Flow|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908151|NCT00603382|FG003|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11233472|NCT02427841|OG000|Outcome|Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)|"PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks.~SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation.~POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity.~Fluorouracil: Given IV~Gemcitabine: Given IV~Image Guided Radiation Therapy: Undergo IG-IMRT~Intensity-Modulated Radiation Therapy: Undergo IG-IMRT~Laboratory Biomarker Analysis: Correlative studies~Nab-paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
11233473|NCT02427841|EG000|Reported Event|Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)|"PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks.~SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation.~POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity.~Fluorouracil: Given IV~Gemcitabine: Given IV~Image Guided Radiation Therapy: Undergo IG-IMRT~Intensity-Modulated Radiation Therapy: Undergo IG-IMRT~Laboratory Biomarker Analysis: Correlative studies~Nab-paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
11233474|NCT02427984|BG000|Baseline|Metal on Metal (MoM)|All the patients of our Division with MoM THA
11233475|NCT02427984|BG001|Baseline|Controls|All the patients of our Division for primary THA
11233476|NCT02427984|BG002|Baseline|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
11233477|NCT02427984|BG003|Baseline|Total|Total of all reporting groups
10908152|NCT00603382|FG004|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908153|NCT00603382|FG005|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908154|NCT00603382|OG000|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
10908155|NCT00603382|OG001|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908156|NCT00603382|OG002|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
11233478|NCT02427984|FG000|Participant Flow|Metal on Metal (MoM)|All the patients of our Division with MoM THA
11233479|NCT02427984|FG001|Participant Flow|Controls|
11233480|NCT02427984|FG002|Participant Flow|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
11233481|NCT02427984|OG000|Outcome|Metal on Metal (MoM)|
11233482|NCT02427984|OG001|Outcome|Control|
11233483|NCT02427984|OG000|Outcome|Ceramic on Ceramic (CoC)|
11233484|NCT02427984|OG001|Outcome|Metal on Metal (MoM)|
11233485|NCT02427984|EG000|Reported Event|Metal on Metal (MoM)|
11233486|NCT02427984|EG001|Reported Event|Ceramic on Ceramic (CoC)|
11233487|NCT02427984|EG002|Reported Event|Controls|
11233488|NCT02428296|BG000|Baseline|PIK3CA-Related Overgrowth Spectrum Patients|"Participants were assessed for sirolimus efficacy at week 0 (before the run-in phase), week 26 (after the run-in phase and before treatment), and at week 52 (after 26 weeks of treatment).~Pharmacokinetic data for sirolimus for children and adults with renal transplants informed dosing algorithms. A target sirolimus plasma concentration of 2-6ng/ml was selected based on in vitro preclinical studies off-label clinical experience, and with the aim of minimizing AEs."
10908157|NCT00603382|OG003|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908158|NCT00603382|OG004|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908159|NCT00603382|OG005|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908160|NCT00603382|EG000|Reported Event|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
10908161|NCT00603382|EG001|Reported Event|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908162|NCT00603382|EG002|Reported Event|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908163|NCT00603382|EG003|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908164|NCT00603382|EG004|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908165|NCT00603382|EG005|Reported Event|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
10908166|NCT00603408|BG000|Baseline|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
10908167|NCT00603408|FG000|Participant Flow|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
10908168|NCT00603408|OG000|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
10908169|NCT00603408|OG000|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
10908170|NCT00603408|EG000|Reported Event|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
10908171|NCT00603447|BG000|Baseline|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
11091149|NCT01533116|EG003|Reported Event|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
11091150|NCT01533181|BG000|Baseline|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
11091151|NCT01533181|BG001|Baseline|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
11342172|NCT03700320|FG000|Participant Flow|Oral SOC Migraine Preventive Medication|Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
11342173|NCT03700320|FG001|Participant Flow|Atogepant 60 mg|Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
11091152|NCT01533181|BG002|Baseline|Total|Total of all reporting groups
11091153|NCT01533181|FG000|Participant Flow|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
10908172|NCT00603447|BG001|Baseline|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908173|NCT00603447|BG002|Baseline|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908174|NCT00603447|BG003|Baseline|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
11172704|NCT02010996|BG001|Baseline|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
11172705|NCT02010996|BG002|Baseline|Total|Total of all reporting groups
11172706|NCT02010996|FG000|Participant Flow|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
11172707|NCT02010996|FG001|Participant Flow|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
11172708|NCT02010996|OG000|Outcome|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
11172709|NCT02010996|OG001|Outcome|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
10908175|NCT00603447|BG004|Baseline|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908176|NCT00603447|BG005|Baseline|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10915108|NCT00634088|FG000|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
11172710|NCT02010996|OG002|Outcome|Vacuum Assisted Closure(Shank)|
11172711|NCT02010996|OG003|Outcome|Axillary Dissection(Shank)|
11172712|NCT02010996|EG000|Reported Event|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
11172713|NCT02010996|EG001|Reported Event|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
11172714|NCT02010996|EG002|Reported Event|Vacuum Assisted Closure(Shank)|
11172715|NCT02010996|EG003|Reported Event|Axillary Dissection(Shank)|
11172716|NCT02011113|BG000|Baseline|Pomalidomide Plus Dexamethasone|Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
11172717|NCT02011113|FG000|Participant Flow|Pomalidomide Plus Dexamethasone|Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are > 75 years of age
11342174|NCT03700320|OG000|Outcome|Oral SOC Migraine Preventive Medication|Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
11091154|NCT01533181|FG001|Participant Flow|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
11091155|NCT01533181|OG000|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
11091156|NCT01533181|OG001|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
11091157|NCT01533181|EG000|Reported Event|Arm A: Topotocan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
11091158|NCT01533181|EG001|Reported Event|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
11091159|NCT01533207|BG000|Baseline|Regimen 1|Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
11091160|NCT01533207|BG001|Baseline|Regimen II|Observation
11091161|NCT01533207|BG002|Baseline|Total|Total of all reporting groups
11091162|NCT01533207|FG000|Participant Flow|Regimen 1|Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
11091163|NCT01533207|FG001|Participant Flow|Regimen II|Observation
11091164|NCT01533207|OG000|Outcome|Regimen 1|Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
11091165|NCT01533207|OG001|Outcome|Regimen II|Observation
11091166|NCT01533207|EG000|Reported Event|Regimen 1|Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
11091167|NCT01533207|EG001|Reported Event|Regimen II|Observation
11091168|NCT01533246|BG000|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11091169|NCT01533246|FG000|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
10908177|NCT00603447|BG006|Baseline|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908178|NCT00603447|BG007|Baseline|Total|Total of all reporting groups
10908179|NCT00603447|FG000|Participant Flow|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908180|NCT00603447|FG001|Participant Flow|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908181|NCT00603447|FG002|Participant Flow|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908182|NCT00603447|FG003|Participant Flow|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908183|NCT00603447|FG004|Participant Flow|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908184|NCT00603447|FG005|Participant Flow|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908185|NCT00603447|FG006|Participant Flow|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908186|NCT00603447|OG000|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908187|NCT00603447|OG001|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908188|NCT00603447|OG002|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908189|NCT00603447|OG003|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908190|NCT00603447|OG004|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908191|NCT00603447|OG005|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908192|NCT00603447|OG006|Outcome|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908193|NCT00603447|EG000|Reported Event|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
11091170|NCT01533246|OG000|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11342175|NCT03700320|OG001|Outcome|Atogepant 60 mg|Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
10908194|NCT00603447|EG001|Reported Event|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908195|NCT00603447|EG002|Reported Event|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
11172718|NCT02011113|OG000|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
11172719|NCT02011113|OG000|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
11172720|NCT02011113|EG000|Reported Event|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
11172721|NCT02011386|BG000|Baseline|Treatment|Treatment: Injection Golimumab 50 mg every month on the same date
11172722|NCT02011386|FG000|Participant Flow|Treatment|Treatment: Injection Golimumab 50 mg every month on the same date
11172723|NCT02011386|OG000|Outcome|Treatment|Treatment: Injection Golimumab 50 mg every month on the same date
11172724|NCT02011386|EG000|Reported Event|Treatment|Treatment: Injection Golimumab 50 mg every month on the same date
11172725|NCT02011464|BG000|Baseline|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
11172726|NCT02011464|BG001|Baseline|Control|Saline infiltrated into posterior compartment
11172727|NCT02011464|BG002|Baseline|Total|Total of all reporting groups
11172728|NCT02011464|FG000|Participant Flow|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
11172729|NCT02011464|FG001|Participant Flow|Control|Saline infiltrated into posterior compartment of the knee
11172730|NCT02011464|OG000|Outcome|Exparel Group/Average Pain Scores at 4 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
11172731|NCT02011464|OG001|Outcome|Control Group/Average Pain Scores at 4 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172732|NCT02011464|OG002|Outcome|Exparel Group/Average Pain Scores at 8 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
11172733|NCT02011464|OG003|Outcome|Control Group/Average Pain Scores at 8 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
11172734|NCT02011464|OG004|Outcome|Exparel Group/Average Pain Scores at 12 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172735|NCT02011464|OG005|Outcome|Control Group/Average Pain Scores at 12 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172736|NCT02011464|OG006|Outcome|Exparel Group/Average Pain Scores at 24 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172737|NCT02011464|OG007|Outcome|Control Group/Average Pain Scores at 24 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172738|NCT02011464|OG008|Outcome|Exparel Group/Average Pain Scores at 48 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172739|NCT02011464|OG009|Outcome|Control Group/Average Pain Scores at 48 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172740|NCT02011464|OG010|Outcome|Exparel Group/Average Pain Scores at 72 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172741|NCT02011464|OG011|Outcome|Control Group/Average Pain Scores at 72 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
11172742|NCT02011464|OG000|Outcome|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
11172743|NCT02011464|OG001|Outcome|Control|Saline infiltrated into posterior compartment
11172744|NCT02011464|EG000|Reported Event|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
11172745|NCT02011464|EG001|Reported Event|Control|Saline infiltrated into posterior compartment
11172746|NCT02011490|BG000|Baseline|Severe Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with severe renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
11172747|NCT02011490|BG001|Baseline|Moderate Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with moderate renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
11172748|NCT02011490|BG002|Baseline|Healthy Control Participants: Part 1 + Part 2|This group includes healthy control participants who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
11172749|NCT02011490|BG003|Baseline|Total|Total of all reporting groups
11172750|NCT02011490|FG000|Participant Flow|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an intravenous (IV) bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
10908196|NCT00603447|EG003|Reported Event|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908197|NCT00603447|EG004|Reported Event|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908198|NCT00603447|EG005|Reported Event|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
10908199|NCT00603447|EG006|Reported Event|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
11172751|NCT02011490|FG001|Participant Flow|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
11172752|NCT02011490|FG002|Participant Flow|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
11172753|NCT02011490|FG003|Participant Flow|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172754|NCT02011490|FG004|Participant Flow|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172755|NCT02011490|FG005|Participant Flow|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172756|NCT02011490|OG000|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
11172757|NCT02011490|OG001|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
11172758|NCT02011490|OG002|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
11172759|NCT02011490|OG003|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172760|NCT02011490|OG004|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172761|NCT02011490|OG005|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172762|NCT02011490|EG000|Reported Event|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
11172763|NCT02011490|EG001|Reported Event|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
11172764|NCT02011490|EG002|Reported Event|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
11174230|NCT02020408|FG000|Participant Flow|[11C]Raclopride, [11C]DASB, Amphetamine|"healthy control women (CW);~women recovered from restricting type anorexia nervosa (REC AN);~women recovered from bulimic type anorexia nervosa (REC AN-BN)~women recovered from from bulimia nervosa (REC BN)"
10908200|NCT00603473|BG000|Baseline|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
10908201|NCT00603473|FG000|Participant Flow|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
10908202|NCT00603473|OG000|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
11172765|NCT02011490|EG003|Reported Event|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172766|NCT02011490|EG004|Reported Event|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172767|NCT02011490|EG005|Reported Event|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
11172768|NCT02011516|BG000|Baseline|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
11172769|NCT02011516|BG001|Baseline|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
11172770|NCT02011516|BG002|Baseline|Total|Total of all reporting groups
11172771|NCT02011516|FG000|Participant Flow|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
11172772|NCT02011516|FG001|Participant Flow|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
11172773|NCT02011516|OG000|Outcome|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
11172774|NCT02011516|OG001|Outcome|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
11172775|NCT02011516|EG000|Reported Event|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
11172776|NCT02011516|EG001|Reported Event|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
11172777|NCT02011893|BG000|Baseline|All Subjects|All subjects who were enrolled in the SUNBURST clinical study
11172778|NCT02011893|FG000|Participant Flow|Enrolled|All subjects enrolled through device activation/randomization
11172779|NCT02011893|FG001|Participant Flow|Arm 1|Tonic stimulation first, then Burst
11172780|NCT02011893|FG002|Participant Flow|Arm 2|Burst stimulation first, then Tonic
11172781|NCT02011893|OG000|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
11172782|NCT02011893|OG001|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
11172783|NCT02011893|EG000|Reported Event|All Subjects|All subjects who were enrolled in the SUNBURST clinical study
11172784|NCT02011945|BG000|Baseline|Dasatinib Only|dasatinib 100 mg QD(CP) or 140 mg QD (AP)
11172785|NCT02011945|BG001|Baseline|Dose Level 1|Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
11172786|NCT02011945|BG002|Baseline|Dose Level 2|Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
11172787|NCT02011945|BG003|Baseline|Total|Total of all reporting groups
11172788|NCT02011945|FG000|Participant Flow|Dasatinib Only|dasatinib 100 mg QD(CP) or 140 mg QD (AP)
11172789|NCT02011945|FG001|Participant Flow|Dose Level 1|Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
11172790|NCT02011945|FG002|Participant Flow|Dose Level 2|Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
11172791|NCT02011945|OG000|Outcome|Dasatinib Only|dasatinib 100 mg QD(CP) or 140 mg QD (AP)
11172792|NCT02011945|OG001|Outcome|Dose Level 1|Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
10908203|NCT00603473|EG000|Reported Event|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
10908204|NCT00603512|BG000|Baseline|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
10908205|NCT00603512|BG001|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
10908206|NCT00603512|BG002|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
10908207|NCT00603512|BG003|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
10908208|NCT00603512|BG004|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
10908209|NCT00603512|BG005|Baseline|Total|Total of all reporting groups
10908210|NCT00603512|FG000|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
10908211|NCT00603512|FG001|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
10908212|NCT00603512|FG002|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
10908213|NCT00603512|FG003|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
10908214|NCT00603512|FG004|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
11172793|NCT02011945|OG002|Outcome|Dose Level 2|Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
10908215|NCT00603512|OG000|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
10908216|NCT00603512|OG001|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
10908217|NCT00603512|OG002|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
10908218|NCT00603512|OG003|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
10908219|NCT00603512|OG004|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
10908220|NCT00603512|EG000|Reported Event|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
11172794|NCT02011945|EG000|Reported Event|Dasatinib Only|dasatinib 100 mg QD(CP) or 140 mg QD (AP)
11172795|NCT02011945|EG001|Reported Event|Dose Level 1|Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
10908221|NCT00603512|EG001|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
10908222|NCT00603512|EG002|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
10908223|NCT00603512|EG003|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
10908224|NCT00603512|EG004|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
10908225|NCT00603525|BG000|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10908226|NCT00603525|BG001|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10908227|NCT00603525|BG002|Baseline|Total|Total of all reporting groups
10908228|NCT00603525|FG000|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
10908229|NCT00603525|FG001|Participant Flow|Ofatumumab|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
10908230|NCT00603525|FG002|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
10908231|NCT00603525|OG000|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10908232|NCT00603525|OG001|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10908233|NCT00603525|OG000|Outcome|Placebo|Placebo was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10908234|NCT00603525|OG000|Outcome|Placebo|
11172796|NCT02011945|EG002|Reported Event|Dose Level 2|Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
11172797|NCT02012192|BG000|Baseline|Ganetespib + Paclitaxel|Drug: ganetespib, 150 mg/m², given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle); Drug: paclitaxel, 80 mg/m2, given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle), until progression.
10908235|NCT00603525|OG001|Outcome|Ofatumumab 700 mg|
10908236|NCT00603525|OG002|Outcome|Placebo or OFA 700 mg: FU Period|
10908237|NCT00603525|EG000|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
10908238|NCT00603525|EG001|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
10908239|NCT00603525|EG002|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
10908240|NCT00603538|BG000|Baseline|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908241|NCT00603538|BG001|Baseline|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908242|NCT00603538|BG002|Baseline|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908243|NCT00603538|BG003|Baseline|Total|Total of all reporting groups
10908244|NCT00603538|FG000|Participant Flow|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
11172798|NCT02012192|BG001|Baseline|Paclitaxel|Drug: paclitaxel: 80 mg/m2, given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle), until progression
11172799|NCT02012192|BG002|Baseline|Total|Total of all reporting groups
11172800|NCT02012192|FG000|Participant Flow|Ganetespib + Paclitaxel|"Drug: ganetespib, 150 mg/m², given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle); Drug: paclitaxel, 80 mg/m2, given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle), until progression.~Ganetespib~Paclitaxel"
11172801|NCT02012192|FG001|Participant Flow|Paclitaxel|"Drug: paclitaxel: 80 mg/m2, given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle), until progression~Paclitaxel"
11172802|NCT02012192|OG000|Outcome|Ganetespib + Paclitaxel|Drug: ganetespib, 150 mg/m², given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle); Drug: paclitaxel, 80 mg/m2, given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle), until progression.
11172803|NCT02012192|OG001|Outcome|Paclitaxel|Drug: paclitaxel: 80 mg/m2, given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle), until progression
11172804|NCT02012192|EG000|Reported Event|Ganetespib + Paclitaxel|Drug: ganetespib, 150 mg/m², given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle); Drug: paclitaxel, 80 mg/m2, given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle), until progression.
11172805|NCT02012192|EG001|Reported Event|Paclitaxel|Drug: paclitaxel: 80 mg/m2, given iv once weekly for 3 out of 4 weeks (days 1, 8, 15 of each 4-weeks/28-days cycle), until progression
11172806|NCT02012218|BG000|Baseline|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172807|NCT02012218|BG001|Baseline|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11174231|NCT02020408|OG000|Outcome|[11C]DASB Binding Potential Control Women|[11C] DASB Binding potential (BPND) in control women (healthy controls)
10908245|NCT00603538|FG001|Participant Flow|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908246|NCT00603538|FG002|Participant Flow|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908247|NCT00603538|OG000|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908248|NCT00603538|OG001|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908249|NCT00603538|OG002|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908250|NCT00603538|OG000|Outcome|CP-751,871 6mg/kg in Combination With Chemotherapy Agents|CP-751,871 6mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908251|NCT00603538|OG001|Outcome|CP-751,871 10mg/kg in Combination With Chemotherapy Agents|CP-751,871 10mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908252|NCT00603538|OG002|Outcome|CP-751,871 20mg/kg in Combination With Chemotherapy Agents|CP-751,871 20mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908253|NCT00603538|EG000|Reported Event|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908254|NCT00603538|EG001|Reported Event|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10915109|NCT00634088|FG001|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
11233489|NCT02428296|FG000|Participant Flow|PIK3CA-Related Overgrowth Spectrum Patients|"Participants were assessed for sirolimus efficacy at week 0 (before the run-in phase), week 26 (after the run-in phase and before treatment), and at week 52 (after 26 weeks of treatment).~Pharmacokinetic data for sirolimus for children and adults with renal transplants informed dosing algorithms. A target sirolimus plasma concentration of 2-6ng/ml was selected based on in vitro preclinical studies off-label clinical experience, and with the aim of minimizing AEs."
10908255|NCT00603538|EG002|Reported Event|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
10908256|NCT00603564|BG000|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
10908257|NCT00603564|BG001|Baseline|Venturi|O2 administration via a conventional Venturi mask
10908258|NCT00603564|BG002|Baseline|Total|Total of all reporting groups
10908259|NCT00603564|FG000|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
10908260|NCT00603564|FG001|Participant Flow|Venturi|O2 administration via a conventional Venturi mask
10908261|NCT00603564|OG000|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
10908262|NCT00603564|OG001|Outcome|Venturi|O2 administration via a conventional Venturi mask
10908263|NCT00603564|EG000|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
10908264|NCT00603564|EG001|Reported Event|Venturi|O2 administration via a conventional Venturi mask
10908265|NCT00603590|BG000|Baseline|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
10908266|NCT00603590|BG001|Baseline|Control|Identical placebo tablet
10908267|NCT00603590|BG002|Baseline|Total|Total of all reporting groups
10908268|NCT00603590|FG000|Participant Flow|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
10908269|NCT00603590|FG001|Participant Flow|Control|Identical placebo tablet
10908270|NCT00603590|OG000|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
10908271|NCT00603590|OG001|Outcome|Control|Identical placebo tablet
10908272|NCT00603590|EG000|Reported Event|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
10908273|NCT00603590|EG001|Reported Event|Control|Identical placebo tablet
10908274|NCT00603642|BG000|Baseline|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
11091171|NCT01533246|EG000|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11091172|NCT01533259|BG000|Baseline|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
11091173|NCT01533259|FG000|Participant Flow|Stribild|Switch from existing treatment regimen to Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 48 weeks
11091174|NCT01533259|OG000|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
11091175|NCT01533259|EG000|Reported Event|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
10908275|NCT00603642|BG001|Baseline|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
10908276|NCT00603642|BG002|Baseline|Total|Total of all reporting groups
10908277|NCT00603642|FG000|Participant Flow|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
10908278|NCT00603642|FG001|Participant Flow|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
10908279|NCT00603642|OG000|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
10908280|NCT00603642|OG001|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
10908281|NCT00603642|EG000|Reported Event|Placebo|
10908282|NCT00603642|EG001|Reported Event|Romiplostim|
10908283|NCT00603720|BG000|Baseline|L-Name in Young|"20 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME.~L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging"
10908284|NCT00603720|BG001|Baseline|Phenylephrine|"25 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days~Phenylephrine: alpha agonist; 10 μg/kg/min infusion during PET study"
10908285|NCT00603720|BG002|Baseline|L-arginine in Young|"20 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days~L-Arginine: aids in nitric oxide production"
10908286|NCT00603720|BG003|Baseline|L-arginine in Old|"20 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days~L-Arginine: aids in nitric oxide production"
10908287|NCT00603720|BG004|Baseline|L-NAME in Old|"20 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME~L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging"
10908288|NCT00603720|BG005|Baseline|Total|Total of all reporting groups
10908289|NCT00603720|FG000|Participant Flow|L-Name in Young|"20 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME.~L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging"
10908290|NCT00603720|FG001|Participant Flow|Phenylephrine|"25 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days~Phenylephrine: alpha agonist; 10 μg/kg/min infusion during PET study"
10908291|NCT00603720|FG002|Participant Flow|L-arginine in Young|"20 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days~L-Arginine: aids in nitric oxide production"
10908292|NCT00603720|FG003|Participant Flow|L-arginine in Old|"20 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days~L-Arginine: aids in nitric oxide production"
10908293|NCT00603720|FG004|Participant Flow|L-NAME in Old|"20 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME~L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging"
10908294|NCT00603720|OG000|Outcome|L-Name in Young|"20 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME.~L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging"
10908295|NCT00603720|OG001|Outcome|Phenylephrine|"25 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days~Phenylephrine: alpha agonist; 10 μg/kg/min infusion during PET study"
10908296|NCT00603720|OG002|Outcome|L-arginine in Young|"20 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days~L-Arginine: aids in nitric oxide production"
10908297|NCT00603720|OG003|Outcome|L-arginine in Old|"20 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days~L-Arginine: aids in nitric oxide production"
10908298|NCT00603720|OG004|Outcome|L-NAME in Old|"20 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME~L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging"
10908299|NCT00603720|EG000|Reported Event|L-Name in Young|"10 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME.~L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging"
10908300|NCT00603720|EG001|Reported Event|Phenylephrine|"10 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days~Phenylephrine: alpha agonist; 10 μg/kg/min infusion during PET study"
10908301|NCT00603720|EG002|Reported Event|L-arginine in Young|"12 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days~L-Arginine: aids in nitric oxide production"
10908302|NCT00603720|EG003|Reported Event|L-arginine in Old|"12 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days~L-Arginine: aids in nitric oxide production"
10908303|NCT00603720|EG004|Reported Event|L-NAME in Old|"10 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME~L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging"
10908304|NCT00603733|BG000|Baseline|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
10908305|NCT00603733|BG001|Baseline|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
10908306|NCT00603733|BG002|Baseline|Total|Total of all reporting groups
10908307|NCT00603733|FG000|Participant Flow|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
11091176|NCT01533428|BG000|Baseline|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
10908308|NCT00603733|FG001|Participant Flow|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
10908309|NCT00603733|OG000|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
10908310|NCT00603733|OG001|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
10908311|NCT00603733|EG000|Reported Event|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
10908312|NCT00603733|EG001|Reported Event|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
10908313|NCT00603746|BG000|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908314|NCT00603746|BG001|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908315|NCT00603746|BG002|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908316|NCT00603746|BG003|Baseline|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908317|NCT00603746|BG004|Baseline|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11091177|NCT01533428|BG001|Baseline|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
11091178|NCT01533428|BG002|Baseline|Total|Total of all reporting groups
10908318|NCT00603746|BG005|Baseline|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908319|NCT00603746|BG006|Baseline|Total|Total of all reporting groups
10908320|NCT00603746|FG000|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908321|NCT00603746|FG001|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908322|NCT00603746|FG002|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11091179|NCT01533428|FG000|Participant Flow|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
11091180|NCT01533428|FG001|Participant Flow|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
11233490|NCT02428296|OG000|Outcome|Affected Tissue|Affected sites were defined by clinical observation.
11233491|NCT02428296|OG001|Outcome|Unaffected Tissue|Unaffected sites showed no overgrowth, nor evidence of skin or vascular abnormalities.
11233492|NCT02428296|OG000|Outcome|PIK3CA-Related Overgrowth Spectrum Patients|"Participants were assessed for sirolimus efficacy at week 0 (before the run-in phase), week 26 (after the run-in phase and before treatment), and at week 52 (after 26 weeks of treatment).~Pharmacokinetic data for sirolimus for children and adults with renal transplants informed dosing algorithms. A target sirolimus plasma concentration of 2-6ng/ml was selected based on in vitro preclinical studies off-label clinical experience, and with the aim of minimizing AEs."
11233493|NCT02428296|OG000|Outcome|Patients With PIK3CA Gene Mutation Treated With Sirolimus|"This is a single-arm, non-randomized, open-label study for the treatment of segmental overgrowth disorders (somatic PIK3CA gene mutation) with Sirolimus in thirty-nine patients.~Sirolimus: Low dose sirolimus will be given in daily dosing to achieve trough levels of 2-6 ng/ ml."
11091181|NCT01533428|OG000|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
10908323|NCT00603746|FG003|Participant Flow|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908324|NCT00603746|FG004|Participant Flow|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908325|NCT00603746|FG005|Participant Flow|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the
10908326|NCT00603746|OG000|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908327|NCT00603746|OG001|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908328|NCT00603746|OG002|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908329|NCT00603746|OG003|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
11091182|NCT01533428|OG001|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
11233494|NCT02428296|EG000|Reported Event|PIK3CA-Related Overgrowth Spectrum Patients|"Participants were assessed for sirolimus efficacy at week 0 (before the run-in phase), week 26 (after the run-in phase and before treatment), and at week 52 (after 26 weeks of treatment).~Pharmacokinetic data for sirolimus for children and adults with renal transplants informed dosing algorithms. A target sirolimus plasma concentration of 2-6ng/ml was selected based on in vitro preclinical studies off-label clinical experience, and with the aim of minimizing AEs."
11233495|NCT02428309|BG000|Baseline|Dose 1 (1x10^8)|Participant received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)
11233496|NCT02428309|FG000|Participant Flow|Dose 1 (1x10^8)|Participant received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)
11233497|NCT02428309|OG000|Outcome|Dose 1 (1x10^8)|Participant received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)
10908330|NCT00603746|OG004|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908331|NCT00603746|OG005|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908332|NCT00603746|EG000|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908333|NCT00603746|EG001|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908334|NCT00603746|EG002|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908335|NCT00603746|EG003|Reported Event|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908336|NCT00603746|EG004|Reported Event|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908337|NCT00603746|EG005|Reported Event|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
10908338|NCT00603798|BG000|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908339|NCT00603798|BG001|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908340|NCT00603798|BG002|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
11233498|NCT02428309|OG000|Outcome|Dose 1 (1x10^8)|Participant received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded).
10908341|NCT00603798|BG003|Baseline|Total|Total of all reporting groups
10908342|NCT00603798|FG000|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908343|NCT00603798|FG001|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908344|NCT00603798|FG002|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908345|NCT00603798|OG000|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908346|NCT00603798|OG001|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908347|NCT00603798|OG002|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908348|NCT00603798|EG000|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
11091183|NCT01533428|EG000|Reported Event|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
11091184|NCT01533428|EG001|Reported Event|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
10908349|NCT00603798|EG001|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908350|NCT00603798|EG002|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
10908351|NCT00603837|BG000|Baseline|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
10908352|NCT00603837|BG001|Baseline|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
10908353|NCT00603837|BG002|Baseline|Total|Total of all reporting groups
10908354|NCT00603837|FG000|Participant Flow|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
10908355|NCT00603837|FG001|Participant Flow|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
11233499|NCT02428309|EG000|Reported Event|Dose 1 (1x10^8)|Participant received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)
11233500|NCT02428413|BG000|Baseline|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
11233501|NCT02428413|BG001|Baseline|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
11233502|NCT02428413|BG002|Baseline|Total|Total of all reporting groups
10908356|NCT00603837|OG000|Outcome|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
10908357|NCT00603837|OG001|Outcome|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
10908358|NCT00603837|EG000|Reported Event|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
11233503|NCT02428413|FG000|Participant Flow|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
11233504|NCT02428413|FG001|Participant Flow|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
10908359|NCT00603837|EG001|Reported Event|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
10908360|NCT00603889|BG000|Baseline|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
10908361|NCT00603889|FG000|Participant Flow|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
10908362|NCT00603889|OG000|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
10908363|NCT00603889|EG000|Reported Event|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
10908364|NCT00603902|BG000|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
10908365|NCT00603902|BG001|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10908366|NCT00603902|BG002|Baseline|Matching Placebo|matching placebo tablets
10908367|NCT00603902|BG003|Baseline|Total|Total of all reporting groups
10908368|NCT00603902|FG000|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg once daily (QD) tablets
10908369|NCT00603902|FG001|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg twice a day (BID) tablets
10908370|NCT00603902|FG002|Participant Flow|Matching Placebo|matching placebo tablets
10908371|NCT00603902|OG000|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
10908372|NCT00603902|OG001|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10908373|NCT00603902|OG002|Outcome|Matching Placebo|matching placebo tablets
10908374|NCT00603902|EG000|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
10908375|NCT00603902|EG001|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
10908376|NCT00603902|EG002|Reported Event|Matching Placebo|matching placebo tablets
10908377|NCT00603915|BG000|Baseline|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
10908378|NCT00603915|FG000|Participant Flow|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
10908379|NCT00603915|OG000|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
11233505|NCT02428413|OG000|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
11233506|NCT02428413|OG001|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
11233507|NCT02428413|EG000|Reported Event|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
11233508|NCT02428413|EG001|Reported Event|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
11172808|NCT02012218|BG002|Baseline|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172809|NCT02012218|BG003|Baseline|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172810|NCT02012218|BG004|Baseline|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172811|NCT02012218|BG005|Baseline|Total|Total of all reporting groups
11172812|NCT02012218|FG000|Participant Flow|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172813|NCT02012218|FG001|Participant Flow|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172814|NCT02012218|FG002|Participant Flow|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172815|NCT02012218|FG003|Participant Flow|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172816|NCT02012218|FG004|Participant Flow|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172817|NCT02012218|OG000|Outcome|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172818|NCT02012218|OG001|Outcome|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172819|NCT02012218|OG002|Outcome|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172820|NCT02012218|OG003|Outcome|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172821|NCT02012218|OG004|Outcome|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172822|NCT02012218|EG000|Reported Event|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172823|NCT02012218|EG001|Reported Event|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172824|NCT02012218|EG002|Reported Event|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172825|NCT02012218|EG003|Reported Event|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172826|NCT02012218|EG004|Reported Event|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
11172827|NCT02012283|BG000|Baseline|No Spice First, Then Spice|Subjects consumed each vegetable without spice first and then with spice mix added
11172828|NCT02012283|BG001|Baseline|Spice First, Then No Spice|Subjects consumed each vegetable with spice mix added first and then without spice
11172829|NCT02012283|BG002|Baseline|Total|Total of all reporting groups
11172830|NCT02012283|FG000|Participant Flow|No Spice First, Then Spice|Subjects receiving plain vegetable, then vegetable with spices added
11172831|NCT02012283|FG001|Participant Flow|Spice First, Then no Spice|Subjects receiving vegetable with mixed-spices added, then plain vegetable
11172832|NCT02012283|OG000|Outcome|Vegetable Intake With and Without Spices|The amount of vegetable consumed with or without spices.
10908380|NCT00603915|EG000|Reported Event|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
10908381|NCT00603941|BG000|Baseline|Cohort 1; 0.15 mg CS-7017|Participants who received 0.15 mg BID oral CS-7017 and 135 [Dose Level 1a] or 175 [Dose Level 1b] mg/m^2 IV paclitaxel once every 3 weeks.
10908382|NCT00603941|BG001|Baseline|Cohort 2; 0.30 mg CS-7017|Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
11172833|NCT02012283|OG000|Outcome|Broccoli Intake Among High Restraint Eaters|Broccoli intake with or without spices in high restraint eaters.
11172834|NCT02012283|OG001|Outcome|Broccoli Intake Among Low Restraint Eaters|Broccoli intake with or without spices in low restraint eaters.
11172835|NCT02012283|EG000|Reported Event|Broccoli With Spices|Subjects consumed broccoli with spices added.
11172836|NCT02012283|EG001|Reported Event|Broccoli No Spices|Subjects consumed broccoli without spices.
11172837|NCT02012283|EG002|Reported Event|Cauliflower With Spices|Subjects consumed cauliflower with spices added.
11172838|NCT02012283|EG003|Reported Event|Cauliflower No Spices|Subjects consumed cauliflower without spices.
11172839|NCT02012283|EG004|Reported Event|Spinach With Spices|Subjects consumed spinach with spices added.
11172840|NCT02012283|EG005|Reported Event|Spinach No Spices|Subjects consumed spinach without spices.
11172841|NCT02012348|BG000|Baseline|Control Soap|"Forearms of subjects in this arm will be washed with control (non-antibacterial) soap~Control soap"
10908383|NCT00603941|BG002|Baseline|Cohort 3; 0.50 mg CS-7017|Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
10908384|NCT00603941|BG003|Baseline|Total|Total of all reporting groups
10908385|NCT00603941|FG000|Participant Flow|Cohort 1; 0.15 mg CS-7017|Participants who received 0.15 mg twice daily (BID) oral CS-7017 and 135 [Dose Level 1a] or 175 [Dose Level 1b] mg/m^2 IV paclitaxel once every 3 weeks.
10908386|NCT00603941|FG001|Participant Flow|Cohort 2; 0.30 mg CS-7017|Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
10908387|NCT00603941|FG002|Participant Flow|Cohort 3; 0.50 mg CS-7017|Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
10908388|NCT00603941|OG000|Outcome|All Patients|All patients who received any dose of CS-7017 combined with paclitaxel chemotherapy.
10908389|NCT00603941|OG000|Outcome|Cohort 1; 0.15 mg CS-7017|Participants who received 0.15 mg BID oral CS-7017 and 135 [Dose Level 1a] or 175 [Dose Level 1b] mg/m^2 IV paclitaxel once every 3 weeks.
10908390|NCT00603941|OG001|Outcome|Cohort 2; 0.30 mg CS-7017|Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
10908391|NCT00603941|OG002|Outcome|Cohort 3; 0.50 mg CS-7017|Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
11172842|NCT02012348|BG001|Baseline|Antibacterial Soap With Triclocarban|"The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban~Antibacterial soap with triclocarban"
11172843|NCT02012348|BG002|Baseline|Antibacterial Soap + Benzalkonium Chloride|"The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride~Antibacterial soap + benzalkonium chloride"
11172844|NCT02012348|BG003|Baseline|Total|Total of all reporting groups
11172845|NCT02012348|FG000|Participant Flow|Control Soap|"Forearms of subjects in this arm will be washed with control (non-antibacterial) soap~Control soap"
11172846|NCT02012348|FG001|Participant Flow|Antibacterial Soap With Triclocarban|"The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban~Antibacterial soap with triclocarban"
11172847|NCT02012348|FG002|Participant Flow|Antibacterial Soap + Benzalkonium Chloride|"The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride~Antibacterial soap + benzalkonium chloride"
11172848|NCT02012348|OG000|Outcome|Control Soap|"Forearms of subjects in this arm will be washed with control (non-antibacterial) soap~Control soap"
11172849|NCT02012348|OG001|Outcome|Antibacterial Soap With Triclocarban|"The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban~Antibacterial soap with triclocarban"
11172850|NCT02012348|OG002|Outcome|Antibacterial Soap + Benzalkonium Chloride|"The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride~Antibacterial soap + benzalkonium chloride"
11172851|NCT02012348|EG000|Reported Event|Control Soap|"Forearms of subjects in this arm will be washed with control (non-antibacterial) soap~Control soap"
11172852|NCT02012348|EG001|Reported Event|Antibacterial Soap With Triclocarban|"The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban~Antibacterial soap with triclocarban"
11172853|NCT02012348|EG002|Reported Event|Antibacterial Soap + Benzalkonium Chloride|"The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride~Antibacterial soap + benzalkonium chloride"
11172854|NCT02012452|BG000|Baseline|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
11172855|NCT02012452|BG001|Baseline|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
11172856|NCT02012452|BG002|Baseline|Total|Total of all reporting groups
11172857|NCT02012452|FG000|Participant Flow|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
11172858|NCT02012452|FG001|Participant Flow|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
10908392|NCT00603941|EG000|Reported Event|Cohort 1; 0.15 mg CS-7017|Participants who received 0.15 mg BID oral CS-7017 and 135 [Dose Level 1a] or 175 [Dose Level 1b] mg/m^2 IV paclitaxel once every 3 weeks.
10908393|NCT00603941|EG001|Reported Event|Cohort 2; 0.30 mg CS-7017|Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
10908394|NCT00603941|EG002|Reported Event|Cohort 3; 0.50 mg CS-7017|Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
10908395|NCT00603980|BG000|Baseline|Qualifying Session (Includes Crossover Group)|"All subjects received Placebo and Oral alprazolam 2 mg in a randomized order to Qualify~Each subject was to receive all 7 interventions (Placebo, Oral alprazolam 1, 2 & 3 mg, Inhaled alprazolam 0.5, 1, & 2 mg) in a randomized order in a crossover design"
10908396|NCT00603980|FG000|Participant Flow|All Subjects Entering|All subjects entering the crossover qualification period
10908397|NCT00603980|OG000|Outcome|Placebo|Inhaled Staccato Placebo +oral placebo
10908398|NCT00603980|OG001|Outcome|Oral Alprazolam 1 mg|Oral alprazolam 1 mg + inhaled placebo
10908399|NCT00603980|OG002|Outcome|Oral Alprazolam 2 mg|Oral alprazolam 2 mg + inhaled placebo
10908400|NCT00603980|OG003|Outcome|Oral Alprazolam 4 mg|Oral alprazolam 4 mg + inhaled placebo
10908401|NCT00603980|OG004|Outcome|Inhaled Alprazolam 0.5 mg|Inhaled Staccato alprazolam 0.5 mg + oral placebo
10908402|NCT00603980|OG005|Outcome|Inhaled Alprazolam 1 mg|Inhaled Staccato alprazolam 1 mg + oral placebo
10908403|NCT00603980|OG006|Outcome|Inhaled Alprazolam 2 mg|Inhaled Staccato alprazolam 0.5 mg + oral placebo placebo
10908404|NCT00603980|OG000|Outcome|Oral Alprazolam 1 mg|Oral alprazolam 1 mg + inhaled placebo
10908405|NCT00603980|OG001|Outcome|Placebo|Inhaled Staccato Placebo +oral placebo
10908406|NCT00603980|EG000|Reported Event|Placebo|Inhaled Staccato Placebo +oral placebo
10908407|NCT00603980|EG001|Reported Event|Oral Alprazolam 1 mg|Oral alprazolam 1 mg + inhaled placebo
10908408|NCT00603980|EG002|Reported Event|Oral Alprazolam 2 mg|Oral alprazolam 2 mg + inhaled placebo
10908409|NCT00603980|EG003|Reported Event|Oral Alprazolam 4 mg|Oral alprazolam 4 mg + inhaled placebo
10908410|NCT00603980|EG004|Reported Event|Inhaled Alprazolam 0.5 mg|Inhaled Staccato alprazolam 0.5 mg + oral placebo
10908411|NCT00603980|EG005|Reported Event|Inhaled Alprazolam 1 mg|Inhaled Staccato alprazolam 1 mg + oral placebo
10908412|NCT00603980|EG006|Reported Event|Inhaled Alprazolam 2 mg|Inhaled Staccato alprazolam 0.5 mg + oral placebo placebo
10908413|NCT00603980|EG007|Reported Event|Qualifying Session 2 mg Oral|Qualifying session, 2 mg oral alprazolam
10908414|NCT00603980|EG008|Reported Event|Qualifying Session Oral Placebo|Qualifying session, oral placebo (alprazolam 0 mg)
10908415|NCT00603993|BG000|Baseline|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
10908416|NCT00603993|FG000|Participant Flow|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
10908417|NCT00603993|OG000|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
10908418|NCT00603993|EG000|Reported Event|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
10908419|NCT00604019|BG000|Baseline|Dopamine|Patients that get DA infusion
10908420|NCT00604019|BG001|Baseline|Norepinephrine|Patients that get NE infusion
10908421|NCT00604019|BG002|Baseline|Total|Total of all reporting groups
10908422|NCT00604019|FG000|Participant Flow|Dopamine|Dopaime infusion via central catheter
10908423|NCT00604019|FG001|Participant Flow|Norepinephrine|Norepinephrine infusion via central catheter
10908424|NCT00604019|OG000|Outcome|Dopamine|Patients getting DA infusion
10908425|NCT00604019|OG001|Outcome|Norepinephrine|Patients getting NE infusion
10908426|NCT00604019|EG000|Reported Event|Dopamine|Patients that get DA infusion
10908427|NCT00604019|EG001|Reported Event|Norepinephrine|Patients that get NE infusion
10908428|NCT00604045|BG000|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
10908429|NCT00604045|BG001|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
10908430|NCT00604045|BG002|Baseline|Total|Total of all reporting groups
10908431|NCT00604045|FG000|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
10908432|NCT00604045|FG001|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
11174232|NCT02020408|OG001|Outcome|[11C]DASB Binding Potential in REC AN|[11C]DASB binding potential in women recovered from restricting type anorexia nervosa (REC AN)
10908433|NCT00604045|OG000|Outcome|1 Attention Bias Modification (ABM)|"The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.~be."
10908434|NCT00604045|OG001|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
10908435|NCT00604045|EG000|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
10908436|NCT00604045|EG001|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
10908437|NCT00604162|BG000|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
10908438|NCT00604162|FG000|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
10908439|NCT00604162|OG000|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
10908440|NCT00604162|OG001|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
10908441|NCT00604162|OG000|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
10908442|NCT00604162|EG000|Reported Event|Adverse Events Related to Colonoscopy|AE related to colonoscopy procedure
10908443|NCT00604162|EG001|Reported Event|Adverse Events Related to the Capsule|AE related to the capsule endoscopy procedure
10908444|NCT00604175|BG000|Baseline|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908445|NCT00604175|BG001|Baseline|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908446|NCT00604175|BG002|Baseline|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
11233509|NCT02428478|BG000|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.
11233510|NCT02428478|FG000|Participant Flow|Desipramine First, Placebo Second|Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
10908447|NCT00604175|BG003|Baseline|Total|Total of all reporting groups
10908448|NCT00604175|FG000|Participant Flow|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908449|NCT00604175|FG001|Participant Flow|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908450|NCT00604175|FG002|Participant Flow|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908451|NCT00604175|OG000|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908452|NCT00604175|OG001|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908453|NCT00604175|OG002|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908454|NCT00604175|OG000|Outcome|Stratum A/Baseline HPV6-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV6 at baseline.
10908455|NCT00604175|OG001|Outcome|Stratum B/Baseline HPV6-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV6 at baseline.
10908456|NCT00604175|OG002|Outcome|Stratum C/Baseline HPV6-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV6 at baseline.
10908457|NCT00604175|OG000|Outcome|Stratum A/Baseline HPV11-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV11 at baseline.
10908458|NCT00604175|OG001|Outcome|Stratum B/Baseline HPV11-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV11 at baseline.
10908459|NCT00604175|OG002|Outcome|Stratum C/Baseline HPV11-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV11 at baseline.
10908460|NCT00604175|OG000|Outcome|Stratum A/Baseline HPV16-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV16 at baseline.
10908461|NCT00604175|OG001|Outcome|Stratum B/Baseline HPV16-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV16 at baseline.
10908462|NCT00604175|OG002|Outcome|Stratum C/Baseline HPV16-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV16 at baseline.
10908463|NCT00604175|OG000|Outcome|Stratum A/Baseline HPV18-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV18 at baseline.
11233511|NCT02428478|FG001|Participant Flow|Placebo First, Desipramine Second|Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
11233512|NCT02428478|OG000|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
11233513|NCT02428478|OG001|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
11233514|NCT02428478|EG000|Reported Event|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
11233515|NCT02428478|EG001|Reported Event|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
11233516|NCT02428595|BG000|Baseline|All Subjects|All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
11233517|NCT02428595|FG000|Participant Flow|All Patients|All patients fit with the device, including patients that did not enter treatment. All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
11233518|NCT02428595|OG000|Outcome|Intent to Treat|All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
11233519|NCT02428595|OG000|Outcome|Per Protocol - 3 Months|Per Protocol cohort - 3 months is defined as all subjects who completed 3 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
10908464|NCT00604175|OG001|Outcome|Stratum B/Baseline HPV18-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV18 at baseline.
10908465|NCT00604175|OG002|Outcome|Stratum C/Baseline HPV18-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV18 at baseline.
10908466|NCT00604175|OG000|Outcome|Stratum A/Baseline HPV6+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV6 at baseline.
10908467|NCT00604175|OG001|Outcome|Stratum B/Baseline HPV6+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV6 at baseline.
10908468|NCT00604175|OG002|Outcome|Stratum C/Baseline HPV6+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV6 at baseline.
10908469|NCT00604175|OG000|Outcome|Stratum A/Baseline HPV11+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV11 at baseline.
10908470|NCT00604175|OG001|Outcome|Stratum B/Baseline HPV11+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV11 at baseline.
10908471|NCT00604175|OG002|Outcome|Stratum C/Baseline HPV11+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV11 at baseline.
10908472|NCT00604175|OG000|Outcome|Stratum A/Baseline HPV16+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV16 at baseline.
10908473|NCT00604175|OG001|Outcome|Stratum B/Baseline HPV16+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV16 at baseline.
11233520|NCT02428595|OG001|Outcome|Per Protocol - 6 Months|Per Protocol cohort - 6 months is defined as all subjects who completed 6 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
11233521|NCT02428595|OG002|Outcome|Per Protocol - 12 Months|Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
11233522|NCT02428595|OG000|Outcome|Per Protocol - 12 Months|Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
11233523|NCT02428595|OG002|Outcome|Per Protocol - 9 Months|Per Protocol cohort - 9 months is defined as all subjects who completed 9 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
11233524|NCT02428595|OG003|Outcome|Per Protocol - 12 Months|Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.
11233525|NCT02428595|OG000|Outcome|Treatment|All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
10908474|NCT00604175|OG002|Outcome|Stratum C/Baseline HPV16+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV16 at baseline.
10908475|NCT00604175|OG000|Outcome|Stratum A/Baseline HPV18+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV18 at baseline.
11172859|NCT02012452|OG000|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
11172860|NCT02012452|OG001|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
11172861|NCT02012452|EG000|Reported Event|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
11172862|NCT02012452|EG001|Reported Event|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
11172863|NCT02012491|BG000|Baseline|Misoprostol|"800 micrograms of vaginal misoprostol alone~Misoprostol"
11172864|NCT02012491|BG001|Baseline|Misoprostol Plus Mifepristone|"800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior~Misoprostol~Mifepristone"
11172865|NCT02012491|BG002|Baseline|Total|Total of all reporting groups
11172866|NCT02012491|FG000|Participant Flow|Misoprostol|"800 micrograms of vaginal misoprostol alone~Misoprostol"
11172867|NCT02012491|FG001|Participant Flow|Misoprostol Plus Mifepristone|"800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior~Misoprostol~Mifepristone"
11172868|NCT02012491|OG000|Outcome|Misoprostol|"800 micrograms of vaginal misoprostol alone~Misoprostol"
10908476|NCT00604175|OG001|Outcome|Stratum B/Baseline HPV18+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV18 at baseline.
10908477|NCT00604175|OG002|Outcome|Stratum C/Baseline HPV18+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV18 at baseline.
11172869|NCT02012491|OG001|Outcome|Misoprostol Plus Mifepristone|"800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior~Misoprostol~Mifepristone"
11172870|NCT02012491|EG000|Reported Event|Misoprostol|"800 micrograms of vaginal misoprostol alone~Misoprostol"
11172871|NCT02012491|EG001|Reported Event|Misoprostol Plus Mifepristone|"800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior~Misoprostol~Mifepristone"
11172872|NCT02012582|BG000|Baseline|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
11172873|NCT02012582|BG001|Baseline|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
11172874|NCT02012582|BG002|Baseline|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
11172875|NCT02012582|BG003|Baseline|Placebo|"0.9 % Sodium chloride infusion~Saline"
11172876|NCT02012582|BG004|Baseline|Total|Total of all reporting groups
11172877|NCT02012582|FG000|Participant Flow|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
11172878|NCT02012582|FG001|Participant Flow|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
11172879|NCT02012582|FG002|Participant Flow|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
11172880|NCT02012582|FG003|Participant Flow|Placebo|"0.9 % Sodium chloride infusion~Placebo"
11172881|NCT02012582|OG000|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
11172882|NCT02012582|OG001|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
11172883|NCT02012582|OG002|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
11172884|NCT02012582|OG003|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
11172885|NCT02012582|EG000|Reported Event|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
11172886|NCT02012582|EG001|Reported Event|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
11172887|NCT02012582|EG002|Reported Event|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
11172888|NCT02012582|EG003|Reported Event|Placebo|"0.9 % Sodium chloride infusion~Placebo"
11172889|NCT02012621|BG000|Baseline|Study Cohort|807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
11172890|NCT02012621|FG000|Participant Flow|Study Cohort|807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
11172891|NCT02012621|OG000|Outcome|Study Cohort|807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
11172892|NCT02012621|EG000|Reported Event|Study Cohort|807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
11172893|NCT02012686|BG000|Baseline|Control Group|numerical rating scale of TENS non-applied group
11172894|NCT02012686|BG001|Baseline|TENS Group|numerical rating scale of TENS applied group
11172895|NCT02012686|BG002|Baseline|Total|Total of all reporting groups
11172896|NCT02012686|FG000|Participant Flow|Control Group|numerical rating scale of TENS non-applied group
11172897|NCT02012686|FG001|Participant Flow|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
11172898|NCT02012686|OG000|Outcome|Control Group|numerical rating scale of TENS non-applied group
11172899|NCT02012686|OG001|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
10908478|NCT00604175|EG000|Reported Event|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908479|NCT00604175|EG001|Reported Event|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908480|NCT00604175|EG002|Reported Event|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
10908481|NCT00604188|BG000|Baseline|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
10908482|NCT00604188|BG001|Baseline|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
10908483|NCT00604188|BG002|Baseline|Total|Total of all reporting groups
10908484|NCT00604188|FG000|Participant Flow|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
11172900|NCT02012686|EG000|Reported Event|Control Group|numerical rating scale of TENS non-applied group
11172901|NCT02012686|EG001|Reported Event|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
11172902|NCT02012959|BG000|Baseline|Treatment Phase A|During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 mEq/L by Day 2, treatment was extended one additional day (Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders. Participants who were responders (serum sodium increased by ≥4 mEq/L) continued to Treatment Phase B (Randomization Phase) on Day 3.
11172903|NCT02012959|FG000|Participant Flow|Treatment Phase A|During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 milliequivalent (mEq)/liter (L) by Day 2, treatment was extended one additional day (Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders.
11172904|NCT02012959|FG001|Participant Flow|Treatment Phase B: Responder - Late Withdrawal|Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
11172905|NCT02012959|FG002|Participant Flow|Treatment Phase B: Responder - Early Withdrawal|Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
11172906|NCT02012959|FG003|Participant Flow|Treatment Phase B: Non-responder - Study Drug|Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion and continued tolvaptan for Days 3 and 4.
11172907|NCT02012959|FG004|Participant Flow|Treatment Phase B: Non-responder - Standard of Care|Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion. The participants in this arm discontinued tolvaptan and received the investigator's preferred standard of care for Days 3 and 4.
11172908|NCT02012959|OG000|Outcome|Responder - Late Withdrawal|Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
11172909|NCT02012959|OG001|Outcome|Responder - Early Withdrawal|Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
11174233|NCT02020408|OG002|Outcome|[11C]DASB Binding Potential in REC ANBN|[11C]DASB binding potential in women recovered from bulimic type anorexia nervosa (REC AN-BN)
11174234|NCT02020408|OG003|Outcome|[11C]DASB Binding Potential in REC BN|[11C]DASB binding potential in women recovered from bulimia nervosa (REC BN)
10908485|NCT00604188|FG001|Participant Flow|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
10908486|NCT00604188|OG000|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
10908487|NCT00604188|OG001|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
10908488|NCT00604188|EG000|Reported Event|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
10908489|NCT00604188|EG001|Reported Event|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
10908490|NCT00604214|BG000|Baseline|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
10908491|NCT00604214|BG001|Baseline|Placebo|0.9% sodium chloride, intravenous, 96 hours
10908492|NCT00604214|BG002|Baseline|Total|Total of all reporting groups
10908493|NCT00604214|FG000|Participant Flow|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
10908494|NCT00604214|FG001|Participant Flow|Placebo|0.9% sodium chloride, intravenous, 96 hours
10908495|NCT00604214|OG000|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
10908496|NCT00604214|OG001|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
10908497|NCT00604214|EG000|Reported Event|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
10908498|NCT00604214|EG001|Reported Event|Placebo|0.9% sodium chloride, intravenous, 96 hours
11172910|NCT02012959|OG000|Outcome|Phase A: All Participants|During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 mEq/L by Day 2, treatment was extended one additional day (Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders.
11172911|NCT02012959|EG000|Reported Event|Treatment Phase A|During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 mEq/L by Day 2, treatment was extended one additional day (to Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders.
11172912|NCT02012959|EG001|Reported Event|Treatment Phase B: Responder - Late Withdrawal|Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Late Withdrawal group (continuing tolvaptan treatment for Days 3 and 4).
10908499|NCT00604279|BG000|Baseline|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
10908500|NCT00604279|BG001|Baseline|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
10908501|NCT00604279|BG002|Baseline|Total|Total of all reporting groups
10908502|NCT00604279|FG000|Participant Flow|Paliperidone Palmitate|Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
10908503|NCT00604279|FG001|Participant Flow|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
10908504|NCT00604279|OG000|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
10908505|NCT00604279|OG001|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
10908506|NCT00604279|EG000|Reported Event|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
10908507|NCT00604279|EG001|Reported Event|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
10908508|NCT00604383|BG000|Baseline|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
10908509|NCT00604383|BG001|Baseline|Placebo|1 tablet, orally, daily, for up to 42 months
10908510|NCT00604383|BG002|Baseline|Total|Total of all reporting groups
10908511|NCT00604383|FG000|Participant Flow|Ruboxistaurin|One 32-milligram (mg) tablet, orally, daily, for up to 42 months
10908512|NCT00604383|FG001|Participant Flow|Placebo|1 tablet, orally, daily, for up to 42 months
10908513|NCT00604383|OG000|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
10908514|NCT00604383|OG001|Outcome|Placebo|1 tablet, orally, daily, for 36 months
10908515|NCT00604383|EG000|Reported Event|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
10908516|NCT00604383|EG001|Reported Event|Placebo|1 tablet, orally, daily, for up to 42 months
10908517|NCT00604461|BG000|Baseline|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
10908518|NCT00604461|FG000|Participant Flow|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
10908519|NCT00604461|OG000|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
11172913|NCT02012959|EG002|Reported Event|Treatment Phase B: Responder - Early Withdrawal|Participants who were responders (serum sodium increased by ≥4 mEq/L) from Phase A continued to Treatment Phase B (Randomization Phase) on Day 3 and were randomized to the Early Withdrawal group (not receiving additional tolvaptan on Days 3 or 4). Participants randomized to Early Withdrawal were monitored for any interventions needed to maintain appropriate serum sodium levels. Where sodium levels declined by ≥4 mEq/L, or where the overall clinical condition warranted further intervention to increase serum sodium levels, participants were treated per the investigator's preferred standard of care. Any intervention, including fluid restriction, during the first 48 hours of the Early Withdrawal phase was defined as rescue therapy, and participant data was censored thereafter.
11172914|NCT02012959|EG003|Reported Event|Treatment Phase B: Non-responder - Study Drug|Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion and continued tolvaptan for Days 3 and 4.
11172915|NCT02012959|EG004|Reported Event|Treatment Phase B: Non-responder - Standard of Care|Participants who were non-responders during Phase A were not randomized in Phase B, but were treated per the investigator's discretion. The participants in this arm discontinued tolvaptan and received the investigator's preferred standard of care for Days 3 and 4.
11172916|NCT02013037|BG000|Baseline|Eculizumab|"Eculizumab: At the time of transplantation, 1200mg of Eculizumab will be administered via a 35 minute IV infusion, followed by thymoglobulin 1.5 mg/kg intravenous piggyback (IVPB). The administration of thymoglobulin will be repeated (if blood counts permit) for a total of five doses.~On Day 1 post-transplant, 900 mg of Eculizumab will be given via an IV infusion.~On Day 5 post-transplant, intravenous immunoglobulin (IVIG) 1 gram/kg will be administered daily for two consecutive days.~On post-transplant days 7, 14, and 21 (+/- 2 days) 900mg of Eculizumab will be given via an IV infusion at each scheduled visit.~On post-transplant days 28, 42, and 56 (+/- 2 days) 1200 mg of Eculizumab will be given via an IV infusion at each scheduled visit."
11172917|NCT02013037|FG000|Participant Flow|Eculizumab|"Eculizumab: At the time of transplantation, 1200mg of Eculizumab will be administered via a 35 minute IV infusion, followed by thymoglobulin 1.5 mg/kg intravenous piggyback (IVPB). The administration of thymoglobulin will be repeated (if blood counts permit) for a total of five doses.~On Day 1 post-transplant, 900 mg of Eculizumab will be given via an IV infusion.~On Day 5 post-transplant, intravenous immunoglobulin (IVIG) 1 gram/kg will be administered daily for two consecutive days.~On post-transplant days 7, 14, and 21 (+/- 2 days) 900mg of Eculizumab will be given via an IV infusion at each scheduled visit.~On post-transplant days 28, 42, and 56 (+/- 2 days) 1200 mg of Eculizumab will be given via an IV infusion at each scheduled visit."
11172918|NCT02013037|OG000|Outcome|Eculizumab|"Administration of Eculizumab to heart transplant recipients at Cedars Sinai Medical Center with a panel reactive antibody (PRA) ≥ 70%, for the prevention of antibody-mediated rejection.~Eculizumab: At the time of transplantation, 1200mg of Eculizumab will be administered via a 35 minute IV infusion, followed by thymoglobulin 1.5 mg/kg intravenous piggyback (IVPB). The administration of thymoglobulin will be repeated (if blood counts permit) for a total of five doses.~On Day 1 post-transplant, 900 mg of Eculizumab will be given via an IV infusion.~On Day 5 post-transplant, intravenous immunoglobulin (IVIG) 1 gram/kg will be administered daily for two consecutive days.~On post-transplant days 7, 14, and 21 (+/- 2 days) 900mg of Eculizumab will be given via an IV infusion at each scheduled visit.~On post-transplant days 28, 42, and 56 (+/- 2 days) 1200 mg of Eculizumab will be given via an IV infusion at each scheduled visit."
11172919|NCT02013037|OG000|Outcome|Eculizumab|"Eculizumab: At the time of transplantation, 1200mg of Eculizumab will be administered via a 35 minute IV infusion, followed by thymoglobulin 1.5 mg/kg intravenous piggyback (IVPB). The administration of thymoglobulin will be repeated (if blood counts permit) for a total of five doses.~On Day 1 post-transplant, 900 mg of Eculizumab will be given via an IV infusion.~On Day 5 post-transplant, intravenous immunoglobulin (IVIG) 1 gram/kg will be administered daily for two consecutive days.~On post-transplant days 7, 14, and 21 (+/- 2 days) 900mg of Eculizumab will be given via an IV infusion at each scheduled visit.~On post-transplant days 28, 42, and 56 (+/- 2 days) 1200 mg of Eculizumab will be given via an IV infusion at each scheduled visit."
11174235|NCT02020408|OG000|Outcome|[11C]Raclopride Binding Potential Control Women|[11C]raclopride binding potential in control women after amphetamine administration
11174236|NCT02020408|OG001|Outcome|[11C]Raclopride Binding Potential in REC AN|[11C]raclopride binding potential in women recovered from restricting type anorexia nervosa (REC AN) after amphetamine administration
11174237|NCT02020408|OG002|Outcome|[11C]Raclopride Binding Potential in REC ANBN|[11C]raclopride binding potential in womenrecovered from bulimic type anorexia nervosa (REC ANBN) after amphetamine administration
10908520|NCT00604461|EG000|Reported Event|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
10908521|NCT00604552|BG000|Baseline|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
10908522|NCT00604552|BG001|Baseline|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
10908523|NCT00604552|BG002|Baseline|Total|Total of all reporting groups
10908524|NCT00604552|FG000|Participant Flow|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
10908525|NCT00604552|FG001|Participant Flow|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
10908526|NCT00604552|OG000|Outcome|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
10908527|NCT00604552|OG001|Outcome|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
10908528|NCT00604552|OG000|Outcome|Lifeline Registry|"All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)~AneuRx Stent Graft: Abdominal Aortic Aneurysm Repair"
10908529|NCT00604552|OG001|Outcome|PS Registry|"All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic~AneuRx Stent Graft: Abdominal Aortic Aneurysm Repair"
10908530|NCT00604552|EG000|Reported Event|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
10908531|NCT00604552|EG001|Reported Event|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
10908532|NCT00604565|BG000|Baseline|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
11233526|NCT02428595|OG001|Outcome|Fitting|The period of time where a patient is fitted with the device in order to determine the correct size. All patients in the Treatment group are also present in the Fitting group. Adverse events which occurred in the Treatment phase are not included here.
11342176|NCT03700320|EG000|Reported Event|Oral SOC Migraine Preventive Medication|Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
10908533|NCT00604565|BG001|Baseline|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
10908534|NCT00604565|BG002|Baseline|Total|Total of all reporting groups
10908535|NCT00604565|FG000|Participant Flow|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
10908536|NCT00604565|FG001|Participant Flow|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
10908537|NCT00604565|OG000|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
10908538|NCT00604565|OG001|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
10908539|NCT00604565|EG000|Reported Event|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
10908540|NCT00604565|EG001|Reported Event|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
10908541|NCT00604669|BG000|Baseline|Those Exposed to TPN|
10908542|NCT00604669|FG000|Participant Flow|Those Exposed to TPN|
10908543|NCT00604669|OG000|Outcome|Those Exposed to TPN|
11342177|NCT03700320|EG001|Reported Event|Atogepant 60 mg|Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
10908544|NCT00604669|EG000|Reported Event|Those Exposed to TPN|
10908545|NCT00604695|BG000|Baseline|Active Treatment|Two (4mg) doses of tenecteplase
10908546|NCT00604695|BG001|Baseline|Placebo Control|Two (4mL) doses of sterile saline
10908547|NCT00604695|BG002|Baseline|Total|Total of all reporting groups
10908548|NCT00604695|FG000|Participant Flow|Active Treatment|Two (4mg) doses of tenecteplase
10908549|NCT00604695|FG001|Participant Flow|Placebo Control|Two (4mL) doses of sterile saline
10908550|NCT00604695|OG000|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
10908551|NCT00604695|OG001|Outcome|Placebo Control|Two (4mL) doses of sterile saline
10908552|NCT00604695|EG000|Reported Event|Active Treatment|Two (4mg) doses of tenecteplase
10908553|NCT00604695|EG001|Reported Event|Placebo Control|Two (4mL) doses of sterile saline
10908554|NCT00604708|BG000|Baseline|IC51|IC51
10908555|NCT00604708|BG001|Baseline|JE-VAX|JE-VAX
10908556|NCT00604708|BG002|Baseline|Total|Total of all reporting groups
11172920|NCT02013037|EG000|Reported Event|Eculizumab|"Administration of Eculizumab to heart transplant recipients at Cedars Sinai Medical Center with a panel reactive antibody (PRA) ≥ 70%, for the prevention of antibody-mediated rejection.~Eculizumab: At the time of transplantation, 1200mg of Eculizumab will be administered via a 35 minute IV infusion, followed by thymoglobulin 1.5 mg/kg intravenous piggyback (IVPB). The administration of thymoglobulin will be repeated (if blood counts permit) for a total of five doses.~On Day 1 post-transplant, 900 mg of Eculizumab will be given via an IV infusion.~On Day 5 post-transplant, intravenous immunoglobulin (IVIG) 1 gram/kg will be administered daily for two consecutive days.~On post-transplant days 7, 14, and 21 (+/- 2 days) 900mg of Eculizumab will be given via an IV infusion at each scheduled visit.~On post-transplant days 28, 42, and 56 (+/- 2 days) 1200 mg of Eculizumab will be given via an IV infusion at each scheduled visit.~2 deaths were reported in participants who received eculizumab. There were 6 deaths in participants who did not complete the study and did not receive eculizumab."
11172921|NCT02013050|BG000|Baseline|Placebo|
11172922|NCT02013050|BG001|Baseline|1.5 mg/kg|
11172923|NCT02013050|BG002|Baseline|3.0 mg/kg|
11172924|NCT02013050|BG003|Baseline|6.0 mg/kg|
11172925|NCT02013050|BG004|Baseline|Total|Total of all reporting groups
11172926|NCT02013050|FG000|Participant Flow|Placebo|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
11172927|NCT02013050|FG001|Participant Flow|1.5 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
10908557|NCT00604708|FG000|Participant Flow|IC51|IC51
10908558|NCT00604708|FG001|Participant Flow|JE-VAX|JE-VAX
10908559|NCT00604708|OG000|Outcome|IC51|IC51
10908560|NCT00604708|OG001|Outcome|JE-VAX|JE-VAX
10908561|NCT00604708|EG000|Reported Event|IC51|IC51
10908562|NCT00604708|EG001|Reported Event|JE-VAX|JE-VAX
10908563|NCT00604721|BG000|Baseline|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
11172928|NCT02013050|FG002|Participant Flow|3.0 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
11172929|NCT02013050|FG003|Participant Flow|6.0 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
11172930|NCT02013050|OG000|Outcome|Placebo|
11172931|NCT02013050|OG001|Outcome|1.5 mg/kg|
11172932|NCT02013050|OG002|Outcome|3.0 mg/kg|
11172933|NCT02013050|OG003|Outcome|6.0 mg/kg|
11172934|NCT02013050|EG000|Reported Event|Placebo|
11172935|NCT02013050|EG001|Reported Event|1.5 mg/kg|
11172936|NCT02013050|EG002|Reported Event|3.0 mg/kg|
11172937|NCT02013050|EG003|Reported Event|6.0 mg/kg|
11172938|NCT02013180|BG000|Baseline|Prostate Cancer|prostate adenocarcinoma in pathologic evaluation
11172939|NCT02013180|BG001|Baseline|Control|benign prostatic diseases in pathologic evaluation
11172940|NCT02013180|BG002|Baseline|Total|Total of all reporting groups
11172941|NCT02013180|FG000|Participant Flow|Prostate Cancer|prostate adenocarcinoma in pathologic evaluation
11172942|NCT02013180|FG001|Participant Flow|Control|benign prostatic diseases in pathologic evaluation
11172943|NCT02013180|OG000|Outcome|Prostate Cancer|prostate adenocarcinoma in pathologic evaluation
11172944|NCT02013180|OG001|Outcome|Control|benign prostatic diseases in pathologic evaluation
11172945|NCT02013180|EG000|Reported Event|Prostate Cancer|prostate adenocarcinoma in pathologic evaluation
11172946|NCT02013180|EG001|Reported Event|Control|benign prostatic diseases in pathologic evaluation
11172947|NCT02013206|BG000|Baseline|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
11172948|NCT02013206|BG001|Baseline|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
11172949|NCT02013206|BG002|Baseline|Total|Total of all reporting groups
11172950|NCT02013206|FG000|Participant Flow|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
11172951|NCT02013206|FG001|Participant Flow|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
11172952|NCT02013206|OG000|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
11172953|NCT02013206|OG001|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
10908564|NCT00604721|FG000|Participant Flow|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
10908565|NCT00604721|OG000|Outcome|Safety Cohort: AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was determined by the algorithm presented in the safety cohort."
10908566|NCT00604721|OG000|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
10908567|NCT00604721|EG000|Reported Event|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
10908568|NCT00604786|BG000|Baseline|Active Treatment|"This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~omalizumab: IgE 30-100 int. units/mL: 30-90 kg: 150 mg every 4 weeks >90-150 kg: 300 mg every 4 weeks~IgE >100-200 int. units/mL:~30-90 kg: 300 mg every 4 weeks >90-150 kg: 225 mg every 2 weeks~IgE >200-300 int. units/mL:~30-60 kg: 300 mg every 4 weeks >60-90 kg: 225 mg every 2 weeks >90-150 kg: 300 mg every 2 weeks~IgE >300-400 int. units/mL:~30-70 kg: 225 mg every 2 weeks >70-90 kg: 300 mg every 2 weeks >90 kg: Do not administer dose~IgE >400-500 int. units/mL:~30-70 kg: 300 mg every 2 weeks >70-90 kg: 375 mg every 2 weeks >90 kg: Do not administer dose~IgE >500-600 int. units/mL:~30-60 kg: 300 mg every 2 weeks >60-70 kg: 375 mg every 2 weeks >70 kg: Do not administer dose~IgE >600-700 int. units/mL:~30-60 kg: 375 mg every 2 weeks >60 kg: Do not administer dose"
10908569|NCT00604786|BG001|Baseline|Placebo|"placebo: IgE 30-100 int. units/mL: 30-90 kg: placebo every 4 weeks >90-150 kg: placebo every 4 weeks~IgE >100-200 int. units/mL:~30-90 kg: placebo every 4 weeks >90-150 kg: placebo every 2 weeks~IgE >200-300 int. units/mL:~30-60 kg: placebo every 4 weeks >60-90 kg: placebo every 2 weeks >90-150 kg: placebo every 2 weeks~IgE >300-400 int. units/mL:~30-70 kg: placebo every 2 weeks >70-90 kg: placebo every 2 weeks >90 kg: Do not administer dose~IgE >400-500 int. units/mL:~30-70 kg: placebo every 2 weeks >70-90 kg: placebo every 2 weeks >90 kg: Do not administer dose~IgE >500-600 int. units/mL:~30-60 kg: placebo every 2 weeks >60-70 kg: placebo every 2 weeks >70 kg: Do not administer dose~IgE >600-700 int. units/mL:~30-60 kg: placebo every 2 weeks >60 kg: Do not administer dose"
10908570|NCT00604786|BG002|Baseline|Total|Total of all reporting groups
10908571|NCT00604786|FG000|Participant Flow|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and immunoglobulin E (IgE) based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
10908572|NCT00604786|FG001|Participant Flow|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
11172954|NCT02013206|EG000|Reported Event|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
11172955|NCT02013206|EG001|Reported Event|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
11172956|NCT02013245|BG000|Baseline|Group 1|MTBVAC low dose group (5 x 10^3 CFU MTBVAC)
11172957|NCT02013245|BG001|Baseline|Group 2|MTBVAC intermediate dose group (5 x 10^4 CFU MTBVAC)
11172958|NCT02013245|BG002|Baseline|Group 3|MTBVAC high dose group (5 x 10^5 CFU MTBVAC)
11172959|NCT02013245|BG003|Baseline|BCG Control Group|BCG standard dose group (5 x 10^5 CFU BCG)
11172960|NCT02013245|BG004|Baseline|Total|Total of all reporting groups
11172961|NCT02013245|FG000|Participant Flow|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
11172962|NCT02013245|FG001|Participant Flow|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
11172963|NCT02013245|FG002|Participant Flow|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
11172964|NCT02013245|FG003|Participant Flow|BCG Control Group|Intervention: Commercially available BCG live vaccine (dose 5 x 10^5 CFU)
11172965|NCT02013245|OG000|Outcome|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
11172966|NCT02013245|OG001|Outcome|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
11172967|NCT02013245|OG002|Outcome|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
10908573|NCT00604786|OG000|Outcome|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
11172968|NCT02013245|OG003|Outcome|BCG Control Group|Intervention: Commercially available BCg live vaccine (standard dose 5 x 10^5 CFU)
11172969|NCT02013245|EG000|Reported Event|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
11172970|NCT02013245|EG001|Reported Event|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
11172971|NCT02013245|EG002|Reported Event|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
11172972|NCT02013245|EG003|Reported Event|BCG Control Group|Intervention: Commercially available BCG live vaccine (standard dose 5 x 10^5 CFU)
11172973|NCT02013375|BG000|Baseline|Haploidentical Transplant|All subjects will undergo pre-conditioning treatment with alemtuzumab (0.3 mg/kg Day -5, Day -4, Day -3) and total body irradiation (300cGy), followed by stem cell transplant, and post-transplant treatment with cyclophosphamide (50mg/kg/day) and sirolimus (target trough level of 10-15ng/mL).
11172974|NCT02013375|FG000|Participant Flow|Haploidentical Transplant|All subjects will undergo pre-conditioning treatment with alemtuzumab (0.3 mg/kg) and total body irradiation (300cGy), followed by stem cell transplant, and post-transplant with cyclophosphamide (50mg/kg/day) and sirolimus (target trough level of 10-15ng/mL).
11172975|NCT02013375|OG000|Outcome|Haploidentical Transplant|All subjects will undergo pre-conditioning treatment with alemtuzumab (0.3 mg/kg Day -5, Day -4, Day -3) and total body irradiation (300cGy), followed by stem cell transplant, and post-transplant treatment with cyclophosphamide (50mg/kg/day) and sirolimus (target trough level of 10-15ng/mL).
11172976|NCT02013375|OG000|Outcome|Haploidentical Transplant|All subjects will undergo pre-conditioning treatment with alemtuzumab (0.3 mg/kg) and total body irradiation (300cGy), followed by stem cell transplant, and post-transplant with cyclophosphamide (50mg/kg/day) and sirolimus (target trough level of 10-15ng/mL).
11172977|NCT02013375|EG000|Reported Event|Haploidentical Transplant|All subjects will undergo pre-conditioning treatment with alemtuzumab (0.3 mg/kg Day -5, Day -4, Day -3) and total body irradiation (300cGy), followed by stem cell transplant, and post-transplant treatment with cyclophosphamide (50mg/kg/day) and sirolimus (target trough level of 10-15ng/mL).
11172978|NCT02013388|BG000|Baseline|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
11172979|NCT02013388|BG001|Baseline|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11172980|NCT02013388|BG002|Baseline|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11172981|NCT02013388|BG003|Baseline|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
11172982|NCT02013388|BG004|Baseline|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11172983|NCT02013388|BG005|Baseline|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
11172984|NCT02013388|BG006|Baseline|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
11172985|NCT02013388|BG007|Baseline|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
11172986|NCT02013388|BG008|Baseline|Total|Total of all reporting groups
11172987|NCT02013388|FG000|Participant Flow|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
11172988|NCT02013388|FG001|Participant Flow|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11172989|NCT02013388|FG002|Participant Flow|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11172990|NCT02013388|FG003|Participant Flow|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
11172991|NCT02013388|FG004|Participant Flow|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11172992|NCT02013388|FG005|Participant Flow|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
11172993|NCT02013388|FG006|Participant Flow|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
11172994|NCT02013388|FG007|Participant Flow|Placebo-single Dose|Placebo: Given PO daily for 1 day
11172995|NCT02013388|OG000|Outcome|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
11172996|NCT02013388|OG001|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11172997|NCT02013388|OG002|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11172998|NCT02013388|OG003|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
11172999|NCT02013388|OG004|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11173000|NCT02013388|OG005|Outcome|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
11173001|NCT02013388|OG006|Outcome|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
11173002|NCT02013388|OG007|Outcome|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
11173003|NCT02013388|OG000|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11173004|NCT02013388|OG001|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11173005|NCT02013388|OG002|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
11173006|NCT02013388|OG003|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11173007|NCT02013388|EG000|Reported Event|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
11173008|NCT02013388|EG001|Reported Event|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11173009|NCT02013388|EG002|Reported Event|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11173010|NCT02013388|EG003|Reported Event|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
11173011|NCT02013388|EG004|Reported Event|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
11173012|NCT02013388|EG005|Reported Event|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
11173013|NCT02013388|EG006|Reported Event|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
11173014|NCT02013388|EG007|Reported Event|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
10908574|NCT00604786|OG001|Outcome|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
10908575|NCT00604786|EG000|Reported Event|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
11173015|NCT02013531|BG000|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
11173016|NCT02013531|FG000|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 milligram per day (mg/day) with titration up to 3 mg/day once daily (QD) in addition to their constant-dose ADT (anti-depressant therapy) for 6 weeks.
11173017|NCT02013531|OG000|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
10908576|NCT00604786|EG001|Reported Event|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
11173018|NCT02013531|EG000|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day to 3 mg/day, QD for 6 weeks.
11173019|NCT02013544|BG000|Baseline|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
11173020|NCT02013544|BG001|Baseline|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
11173021|NCT02013544|BG002|Baseline|Total|Total of all reporting groups
11173022|NCT02013544|FG000|Participant Flow|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks
11173023|NCT02013544|FG001|Participant Flow|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
11173024|NCT02013544|OG000|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
11173025|NCT02013544|OG001|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
11173026|NCT02013544|EG000|Reported Event|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
11173027|NCT02013544|EG001|Reported Event|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks
11173028|NCT02013609|BG000|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
11173029|NCT02013609|FG000|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 milligram per day (mg/day) for the first week with titration up to 3 mg/day once daily (QD) in addition to their constant-dose antidepressant therapy (ADT) for 12 weeks.
11173030|NCT02013609|OG000|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
11173031|NCT02013609|EG000|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
11173032|NCT02013622|BG000|Baseline|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
11173033|NCT02013622|FG000|Participant Flow|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.
11173034|NCT02013622|OG000|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
11173035|NCT02013622|EG000|Reported Event|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
11173036|NCT02013674|BG000|Baseline|Group 1: 20 Million Allogeneic hMSCs|"Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10^8 (20 million) Allo-hMSCs.~Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection"
11173037|NCT02013674|BG001|Baseline|Group 2: 100 Million Allogeneic hMSCs|"Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs.~Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection"
11173038|NCT02013674|BG002|Baseline|Total|Total of all reporting groups
10908577|NCT00604825|BG000|Baseline|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
10908578|NCT00604825|BG001|Baseline|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
10908579|NCT00604825|BG002|Baseline|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
11173039|NCT02013674|FG000|Participant Flow|Group 1: 20 Million Allogeneic hMSCs|"Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10^8 (20 million) Allo-hMSCs.~Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection"
11173040|NCT02013674|FG001|Participant Flow|Group 2: 100 Million Allogeneic hMSCs|"Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs.~Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection"
11173041|NCT02013674|OG000|Outcome|Group 1: 20 Million Allogeneic hMSCs|"Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10^8 (20 million) Allo-hMSCs.~Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection"
11173042|NCT02013674|OG001|Outcome|Group 2: 100 Million Allogeneic hMSCs|"Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs.~Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection"
11173043|NCT02013674|EG000|Reported Event|Group 1: 20 Million Allogeneic hMSCs|"Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10^8 (20 million) Allo-hMSCs.~Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection"
11173044|NCT02013674|EG001|Reported Event|Group 2: 100 Million Allogeneic hMSCs|"Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs.~Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection"
11173045|NCT02013687|BG000|Baseline|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173046|NCT02013687|BG001|Baseline|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173047|NCT02013687|BG002|Baseline|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173048|NCT02013687|BG003|Baseline|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173049|NCT02013687|BG004|Baseline|Total|Total of all reporting groups
11173050|NCT02013687|FG000|Participant Flow|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173051|NCT02013687|FG001|Participant Flow|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173052|NCT02013687|FG002|Participant Flow|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173053|NCT02013687|FG003|Participant Flow|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173054|NCT02013687|OG000|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173055|NCT02013687|OG001|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173056|NCT02013687|OG002|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173057|NCT02013687|OG003|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
11173058|NCT02013687|OG000|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
11173059|NCT02013687|OG001|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
11173060|NCT02013687|OG002|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
11173061|NCT02013687|OG003|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
11173062|NCT02013687|EG000|Reported Event|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
11173063|NCT02013687|EG001|Reported Event|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
11173064|NCT02013687|EG002|Reported Event|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
11173065|NCT02013687|EG003|Reported Event|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
11173066|NCT02013765|BG000|Baseline|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
11173067|NCT02013765|FG000|Participant Flow|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
11173068|NCT02013765|OG000|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
11173069|NCT02013765|EG000|Reported Event|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
11173070|NCT02013778|BG000|Baseline|TACE + HCQ|"Subjects will receive HCQ plus standard of care TACE.~HCQ"
11173071|NCT02013778|FG000|Participant Flow|TACE + HCQ|Subjects will receive Hydroxychloroquine (HCQ) plus standard of care Transarterial Chemoembolization (TACE).
11173072|NCT02013778|OG000|Outcome|TACE + HCQ|"Subjects will receive HCQ plus standard of care TACE.~HCQ"
11173073|NCT02013778|EG000|Reported Event|TACE + HCQ|"Subjects will receive HCQ plus standard of care TACE.~HCQ"
11173074|NCT02013791|BG000|Baseline|Stage 1 Cohort 5A|Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
11173075|NCT02013791|BG001|Baseline|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
11173076|NCT02013791|BG002|Baseline|Stage 1 Cohort 6C|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
10908580|NCT00604825|BG003|Baseline|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
10908581|NCT00604825|BG004|Baseline|Total|Total of all reporting groups
10908582|NCT00604825|FG000|Participant Flow|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
10908583|NCT00604825|FG001|Participant Flow|GSK232802 25 mg|Eligible participants received GSK232802 25 milligram (mg) tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
10908584|NCT00604825|FG002|Participant Flow|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
10908585|NCT00604825|FG003|Participant Flow|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
10908586|NCT00604825|OG000|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
10908587|NCT00604825|OG001|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
10908588|NCT00604825|OG002|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
10908589|NCT00604825|OG003|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
10908590|NCT00604825|EG000|Reported Event|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
10908591|NCT00604825|EG001|Reported Event|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
10908592|NCT00604825|EG002|Reported Event|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
10908593|NCT00604825|EG003|Reported Event|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
10908594|NCT00604890|BG000|Baseline|3% BID|3.0% active twice daily (BID)
10908595|NCT00604890|BG001|Baseline|3% QD|3.0% active cream once daily (QD) plus placebo cream QD
10908596|NCT00604890|BG002|Baseline|1.5% QD|1.5% active cream once daily (QD) plus placebo cream QD
10908597|NCT00604890|BG003|Baseline|Placebo|Placebo cream twice daily (BID)
10908598|NCT00604890|BG004|Baseline|Total|Total of all reporting groups
10908599|NCT00604890|FG000|Participant Flow|3% Active Cream BID(Twice Daily)|Topical Treatment 3.0% active cream applied to the lesion twice daily (BID)
10908600|NCT00604890|FG001|Participant Flow|3% Active Cream QD(Once Daily)|Topical treatment 3.0% active cream applied to the lesion once daily (PM) plus placebo cream applied to the lesion once daily (AM)
10908601|NCT00604890|FG002|Participant Flow|1.5% Active Cream QD(Once Daily)|Topical treatment 1.5% active cream applied to the lesion once daily (PM) plus placebo cream applied to the lesion once daily (AM)
10908602|NCT00604890|FG003|Participant Flow|Placebo BID(Twice Daily)|Placebo cream applied to the lesion twice daily
10908603|NCT00604890|OG000|Outcome|3% Active Cream BID|3.0% active cream twice daily (BID)
10908604|NCT00604890|OG001|Outcome|3% Active Cream QD|3.0% active cream once daily (QD) plus placebo cream QD
10908605|NCT00604890|OG002|Outcome|1.5% QD|1.5% active cream once daily (QD) plus placebo cream QD
10908606|NCT00604890|OG003|Outcome|Placebo BID|Placebo cream twice daily (BID)
10908607|NCT00604890|OG001|Outcome|3% QD|3.0% active cream once daily (QD) plus placebo cream QD
10908608|NCT00604890|EG000|Reported Event|3% Active Cream BID|3.0% active cream twice daily (BID)
10908609|NCT00604890|EG001|Reported Event|3% QD|3.0% active cream once daily QD plus placebo cream QD
10908610|NCT00604890|EG002|Reported Event|1.5% QD|1.5% active cream once daily (QD) plus placebo cream QD
10908611|NCT00604890|EG003|Reported Event|Placebo BID|Placebo cream twice daily (BID)
10908612|NCT00604968|BG000|Baseline|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
10908613|NCT00604968|FG000|Participant Flow|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
10908614|NCT00604968|OG000|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
10908615|NCT00604968|EG000|Reported Event|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
10908616|NCT00605033|BG000|Baseline|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
10908617|NCT00605033|BG001|Baseline|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
10908618|NCT00605033|BG002|Baseline|Total|Total of all reporting groups
10908619|NCT00605033|FG000|Participant Flow|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
10908620|NCT00605033|FG001|Participant Flow|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
10908621|NCT00605033|OG000|Outcome|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
10908622|NCT00605033|OG001|Outcome|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
10908623|NCT00605033|EG000|Reported Event|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
10908624|NCT00605033|EG001|Reported Event|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
10908625|NCT00605072|BG000|Baseline|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908626|NCT00605072|BG001|Baseline|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908627|NCT00605072|BG002|Baseline|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908628|NCT00605072|BG003|Baseline|Total|Total of all reporting groups
10908629|NCT00605072|FG000|Participant Flow|Lisinopril|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908630|NCT00605072|FG001|Participant Flow|Candesartan|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908631|NCT00605072|FG002|Participant Flow|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908632|NCT00605072|OG000|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908633|NCT00605072|OG001|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908634|NCT00605072|OG002|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908635|NCT00605072|EG000|Reported Event|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
11173077|NCT02013791|BG003|Baseline|Stage 1 Cohort 3|Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
10908636|NCT00605072|EG001|Reported Event|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908637|NCT00605072|EG002|Reported Event|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
10908638|NCT00605085|BG000|Baseline|IC51|IC51
10908639|NCT00605085|BG001|Baseline|Placebo|Placebo
10908640|NCT00605085|BG002|Baseline|Total|Total of all reporting groups
10908641|NCT00605085|FG000|Participant Flow|IC51|IC51
10908642|NCT00605085|FG001|Participant Flow|Placebo|Placebo
10908643|NCT00605085|OG000|Outcome|IC51|IC51
10908644|NCT00605085|OG001|Outcome|Placebo|Placebo
10908645|NCT00605085|EG000|Reported Event|IC51|IC51
11173078|NCT02013791|BG004|Baseline|Stage 1 Cohort 2|Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
10908646|NCT00605085|EG001|Reported Event|Placebo|Placebo
10908647|NCT00605176|BG000|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908648|NCT00605176|BG001|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908649|NCT00605176|BG002|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908650|NCT00605176|BG003|Baseline|Total|Total of all reporting groups
10908651|NCT00605176|FG000|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908652|NCT00605176|FG001|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908653|NCT00605176|FG002|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908654|NCT00605176|OG000|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908655|NCT00605176|OG001|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908656|NCT00605176|OG002|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908657|NCT00605176|EG000|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908658|NCT00605176|EG001|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908659|NCT00605176|EG002|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
10908660|NCT00605189|BG000|Baseline|VAC NPWT|Powered Suction Pump (VAC Freedom): continuous suction
10908661|NCT00605189|BG001|Baseline|Gauze-Based NPWT|Powered Suction Pump: continuous suction
10908662|NCT00605189|BG002|Baseline|Moist Wound Therapy|MWT: moist wound therapy
10908663|NCT00605189|BG003|Baseline|Total|Total of all reporting groups
10908664|NCT00605189|FG000|Participant Flow|VAC NPWT|Powered Suction Pump (VAC Freedom): continuous suction, foam based negative pressure wound therapy
11173079|NCT02013791|BG005|Baseline|Stage 1 Cohort 6B|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
11173080|NCT02013791|BG006|Baseline|Stage 1 Cohort 6D|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
11173081|NCT02013791|BG007|Baseline|Stage 1 Cohort 6A|Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
10908665|NCT00605189|FG001|Participant Flow|Gauze-Based NPWT|Powered Suction Pump: continuous suction; gauze based negative pressure wound therapy
10908666|NCT00605189|FG002|Participant Flow|Moist Wound Therapy|MWT: moist wound therapy
10908667|NCT00605189|OG000|Outcome|VAC NPWT|Powered Suction Pump (VAC Freedom): continuous suction
10908668|NCT00605189|OG001|Outcome|Gauze-Based NPWT|Powered Suction Pump: continuous suction
10908669|NCT00605189|OG002|Outcome|Moist Wound Therapy|MWT: moist wound therapy
10908670|NCT00605189|EG000|Reported Event|VAC NPWT|Powered Suction Pump (VAC Freedom): continuous suction
10908671|NCT00605189|EG001|Reported Event|Gauze-Based NPWT|Powered Suction Pump: continuous suction
10908672|NCT00605189|EG002|Reported Event|Moist Wound Therapy|MWT: moist wound therapy
10908673|NCT00605202|BG000|Baseline|Entire Study Population|
10908674|NCT00605202|FG000|Participant Flow|Licorice First, Then Licorice and HCTZ|Licorice 32 grams a day in the first intervention period, then licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the second intervention period.
10908675|NCT00605202|FG001|Participant Flow|Licorice and HCTZ First, Then Licorice|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the first intervention period, then licorice 32 grams a day in the second intervention period.
10908676|NCT00605202|OG000|Outcome|Licorice|
10908677|NCT00605202|OG001|Outcome|Licorice and HCTZ|
10908678|NCT00605202|EG000|Reported Event|Licorice|Licorice 32 grams a day
10908679|NCT00605202|EG001|Reported Event|Licorice and HCTZ|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily
10908680|NCT00605267|BG000|Baseline|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
10908681|NCT00605267|BG001|Baseline|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
10908682|NCT00605267|BG002|Baseline|Total|Total of all reporting groups
10908683|NCT00605267|FG000|Participant Flow|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
11173082|NCT02013791|BG008|Baseline|Stage 1 Cohort 1|Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
11173083|NCT02013791|BG009|Baseline|Total|Total of all reporting groups
11173084|NCT02013791|FG000|Participant Flow|Stage 1 Cohort 5A|Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
11173085|NCT02013791|FG001|Participant Flow|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
11173086|NCT02013791|FG002|Participant Flow|Stage 1 Cohort 6C|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
10908684|NCT00605267|FG001|Participant Flow|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
10908685|NCT00605267|OG000|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
10908686|NCT00605267|OG001|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
10908687|NCT00605267|EG000|Reported Event|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
10908688|NCT00605267|EG001|Reported Event|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
10908689|NCT00605280|BG000|Baseline|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
10908690|NCT00605280|BG001|Baseline|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
10908691|NCT00605280|BG002|Baseline|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
10908692|NCT00605280|BG003|Baseline|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
10908693|NCT00605280|BG004|Baseline|Total|Total of all reporting groups
10908694|NCT00605280|FG000|Participant Flow|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
10908695|NCT00605280|FG001|Participant Flow|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks for 2 years or withdrawing from the study.
10908696|NCT00605280|FG002|Participant Flow|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from the study.
10908697|NCT00605280|FG003|Participant Flow|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
11173087|NCT02013791|FG003|Participant Flow|Stage 1 Cohort 3|Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
10908698|NCT00605280|OG000|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
10908699|NCT00605280|OG001|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
10908700|NCT00605280|EG000|Reported Event|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks from baseline up to 2 years. Includes participants randomized to 0.3 mg pegaptanib sodium and participants randomized to lower doses of pegaptanib sodium who then converted to 0.3 mg pegaptanib sodium; for participants who converted to 0.3 mg pegaptanib sodium, only events that occurred while receiving 0.3 mg pegaptanib sodium treatment are reported.
10908701|NCT00605280|EG001|Reported Event|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
10908702|NCT00605280|EG002|Reported Event|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
10908703|NCT00605280|EG003|Reported Event|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe) from baseline up to Year 2. Events reported for participants after start of sham, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
10908704|NCT00605280|EG004|Reported Event|0.3 mg Pegaptanib Sodium (Year 3)|Participants who were originally randomized to pegaptanib sodium, 0.3 mg who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
10908705|NCT00605280|EG005|Reported Event|Sham Conversion (Year 3)|Participants who were originally randomized to Sham who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
10908706|NCT00605293|BG000|Baseline|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
10908707|NCT00605293|BG001|Baseline|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
10908708|NCT00605293|BG002|Baseline|Total|Total of all reporting groups
11233527|NCT02428595|EG000|Reported Event|Fitting|All subjects who underwent the fitting process (interacted with a device), including those who did not enter the treatment period. The fitting process involved an office visit with a pelvic exam, followed by test fittings of the device to determine the correct size. Patients who were successfully fit then took home the Trial Insert device and wore it during the 2 weeks during which they collected diary data (logging bowel movements and incontinence episodes). This trial wear period was allowed to be extended due to scheduling or if the patient chose not to use the device during their menstrual cycle. Patients who did not achieve a successful fit were allowed to change device size and repeat the trial period up to 2 additional times (for a total of 3 fitting cycles).
10908709|NCT00605293|FG000|Participant Flow|C.E.R.A|Participants received starting dose of 120, 200 or 360 micrograms (mcg) of C.E.R.A intravenously (IV) once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
10908710|NCT00605293|FG001|Participant Flow|Epoetin Alfa|Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), and 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
10908711|NCT00605293|OG000|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
10908712|NCT00605293|OG001|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
10908713|NCT00605293|EG000|Reported Event|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
10908714|NCT00605293|EG001|Reported Event|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
10908715|NCT00605306|BG000|Baseline|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
10908716|NCT00605306|BG001|Baseline|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
10908717|NCT00605306|BG002|Baseline|Total|Total of all reporting groups
10908718|NCT00605306|FG000|Participant Flow|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
10908719|NCT00605306|FG001|Participant Flow|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
10908720|NCT00605306|OG000|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
10908721|NCT00605306|OG001|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
11233528|NCT02428595|EG001|Reported Event|Treatment|All subjects who were successfully fit and completed their eligibility diary and who entered the 12 month treatment period. This includes patients who did not complete treatment. In treatment, subjects wore the Eclipse Insert and inflated it 3x per day using the provided Pump. Patients could remove and reinsert the device as needed for cleaning or pelvic rest.
11233529|NCT02428608|BG000|Baseline|Botulinum Toxin, Type A|"DWP-450 (Botulinum toxin, Type A)~DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A"
11233530|NCT02428608|FG000|Participant Flow|Botulinum Toxin, Tyoe A|"DWP-450 (Botulinum toxin, Type A)~DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A"
11233531|NCT02428608|OG000|Outcome|Botulinum Toxin, Tyoe A|"DWP-450 (Botulinum toxin, Type A)~DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A"
11233532|NCT02428608|OG000|Outcome|Botulinum Toxin, Type A|"DWP-450 (Botulinum toxin, Type A)~DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A"
11233533|NCT02428608|EG000|Reported Event|Botulinum Toxin, Type A|"DWP-450 (Botulinum toxin, Type A)~DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A"
11233534|NCT02428699|BG000|Baseline|Overall Study|Test product : 30 mL Scott's Emulsion containing 10% Cod Liver Oil, 10% Cod Oil. Reference product: 5.8 mL of non emulsified free flowing cod liver oil
11233535|NCT02428699|FG000|Participant Flow|Scott's Emulsion Followed by Non Emulsified Cod Liver Oil|Sequence 1: Participants were administered 30 milliliters (mL) of Scott's emulsion (10 percent [%] Cod Liver Oil, 10% Cod Oil) followed by 300 mL of apple juice in period 1. After a washout period of 2 weeks participants were administered 5.8 mL non emulsified cod liver oil, followed by 300 ml apple juice in period 2.
11233536|NCT02428699|FG001|Participant Flow|Non Emulsified Cod Liver Oil Followed by Scott's Emulsion|Sequence 2: Firstly, participants were administered 5.8 mL non emulsified cod liver oil, followed by 300 mL of apple juice in Period 1. After a washout period of 2 weeks participants were administered test product i.e. 30 mL of Scott's emulsion (10 % Cod Liver Oil, 10% Cod Oil) followed by 300 mL apple juice in period 2.
11233537|NCT02428699|OG000|Outcome|Test Product|30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
10908722|NCT00605306|EG000|Reported Event|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
10908723|NCT00605306|EG001|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
11233538|NCT02428699|OG001|Outcome|Reference Product|5.8 mL of non emulsified free flowing cod liver oil
11233539|NCT02428699|OG000|Outcome|Test Product|30 mL Scott's Emulsion containing 10% cod liver Oil, and 10% cod oil
11233540|NCT02428699|OG000|Outcome|Test Product|30 mL Scott's Emulsion containing 10% cod liver oil, and 10% cod oil
11233541|NCT02428699|OG000|Outcome|Test Product|30 mL Scott's Emulsion containing 10% Cod Liver Oil, 10% Cod Oil
11233542|NCT02428699|OG000|Outcome|Test Product|30 mL Scott's Emulsion containing 10% Cod Liver Oil, 10% Cod Oil.
11233543|NCT02428699|OG000|Outcome|Test Product|30 mL Scott's Emulsion containing 10% cod liver oil, 10% cod oil
11233544|NCT02428699|EG000|Reported Event|Test Product|30 mL Scott's Emulsion containing 10% cod liver oil, 10% cod oil
11233545|NCT02428699|EG001|Reported Event|Reference Product|5.8 mL of non emulsified free flowing cod liver oil
11233546|NCT02428855|BG000|Baseline|Dasatinib|"Patients with advanced intrahepatic cholangiocarcinoma who have either IDH1 or IDH2 mutations and have received at least one prior platinum containing regimen~Dasatinib, oral, daily, predetermined dosage per cycle~Radiologic Response Assessment every 2 cycles~Dasatinib"
11233547|NCT02428855|FG000|Participant Flow|Dasatinib|"Patients with advanced intrahepatic cholangiocarcinoma who have either IDH1 or IDH2 mutations and have received at least one prior platinum containing regimen~Dasatinib, oral, daily, predetermined dosage per cycle~Radiologic Response Assessment every 2 cycles~Dasatinib"
11233548|NCT02428855|OG000|Outcome|Dasatinib|"Patients with advanced intrahepatic cholangiocarcinoma who have either IDH1 or IDH2 mutations and have received at least one prior platinum containing regimen~Dasatinib, oral, daily, predetermined dosage per cycle~Radiologic Response Assessment every 2 cycles~Dasatinib"
11233549|NCT02428855|EG000|Reported Event|Dasatinib|"Patients with advanced intrahepatic cholangiocarcinoma who have either IDH1 or IDH2 mutations and have received at least one prior platinum containing regimen~Dasatinib, oral, daily, predetermined dosage per cycle~Radiologic Response Assessment every 2 cycles"
11233550|NCT02429115|BG000|Baseline|Face-to-face Peer Mentoring Patients|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233551|NCT02429115|BG001|Baseline|Online Peer Mentoring Patients|"Will receive 6 months of online peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233552|NCT02429115|BG002|Baseline|Control Patients|Will not receive peer mentoring.
11233553|NCT02429115|BG003|Baseline|Face-to-face Peer Mentoring Caregivers|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233554|NCT02429115|BG004|Baseline|Online Peer Mentoring Caregivers|"Will receive 6 months of online peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233555|NCT02429115|BG005|Baseline|Control Caregivers|Will not receive peer mentoring.
11233556|NCT02429115|BG006|Baseline|Total|Total of all reporting groups
11233557|NCT02429115|FG000|Participant Flow|Face-to-face Peer Mentoring Patients|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233558|NCT02429115|FG001|Participant Flow|Online Peer Mentoring Patients|"Will receive 6 months of online peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233559|NCT02429115|FG002|Participant Flow|Control Patients|Will not receive peer mentoring.
11233560|NCT02429115|FG003|Participant Flow|Face-to-face Peer Mentoring Caregivers|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233561|NCT02429115|FG004|Participant Flow|Online Peer Mentoring Caregivers|"Will receive 6 months of online peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233562|NCT02429115|FG005|Participant Flow|Control Caregivers|Will not receive peer mentoring.
10908724|NCT00605319|BG000|Baseline|Toviaz (Fesoterodine)|"Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908725|NCT00605319|FG000|Participant Flow|Toviaz (Fesoterodine)|"Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908726|NCT00605319|OG000|Outcome|IPSS Obstructive|"Obstructive description~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908727|NCT00605319|OG000|Outcome|IPSS Irritative|"Irritative description~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908728|NCT00605319|OG000|Outcome|IPSS Nocturia|"Nocturia description~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908729|NCT00605319|OG000|Outcome|IPSS QoL|"QoL description~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908730|NCT00605319|OG000|Outcome|Qmax|"Qmax~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908731|NCT00605319|OG000|Outcome|QAvg|"QAvg~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908732|NCT00605319|OG000|Outcome|Post-void Residual Volume (PVR)|"PVR~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908733|NCT00605319|EG000|Reported Event|Toviaz (Fesoterodine)|"Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
10908734|NCT00605345|BG000|Baseline|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
10908735|NCT00605345|BG001|Baseline|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
10908736|NCT00605345|BG002|Baseline|Total|Total of all reporting groups
10908737|NCT00605345|FG000|Participant Flow|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
10908738|NCT00605345|FG001|Participant Flow|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
10908739|NCT00605345|OG000|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
10908740|NCT00605345|OG001|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
10908741|NCT00605345|EG000|Reported Event|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
10908742|NCT00605345|EG001|Reported Event|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
10908743|NCT00605358|BG000|Baseline|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
10908744|NCT00605358|BG001|Baseline|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
10908745|NCT00605358|BG002|Baseline|Total|Total of all reporting groups
10908746|NCT00605358|FG000|Participant Flow|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
10908747|NCT00605358|FG001|Participant Flow|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
10908748|NCT00605358|OG000|Outcome|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
10908749|NCT00605358|OG001|Outcome|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
10908750|NCT00605358|EG000|Reported Event|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
10908751|NCT00605358|EG001|Reported Event|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
10908752|NCT00605384|BG000|Baseline|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
10908753|NCT00605384|BG001|Baseline|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
10908754|NCT00605384|BG002|Baseline|Total|Total of all reporting groups
10908755|NCT00605384|FG000|Participant Flow|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
10908756|NCT00605384|FG001|Participant Flow|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
10908757|NCT00605384|OG000|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
10908758|NCT00605384|OG001|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
10908759|NCT00605384|EG000|Reported Event|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
10908760|NCT00605384|EG001|Reported Event|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
10908761|NCT00605423|BG000|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
10908762|NCT00605423|BG001|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
10908763|NCT00605423|BG002|Baseline|Total|Total of all reporting groups
10908764|NCT00605423|FG000|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
10908765|NCT00605423|FG001|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
10908766|NCT00605423|OG000|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
10908767|NCT00605423|OG001|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
10908768|NCT00605423|EG000|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
10908769|NCT00605423|EG001|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
10908770|NCT00605475|BG000|Baseline|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
10908771|NCT00605475|BG001|Baseline|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
10908772|NCT00605475|BG002|Baseline|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
10908773|NCT00605475|BG003|Baseline|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
10908774|NCT00605475|BG004|Baseline|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
10908775|NCT00605475|BG005|Baseline|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
10908776|NCT00605475|BG006|Baseline|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
10908777|NCT00605475|BG007|Baseline|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
10908778|NCT00605475|BG008|Baseline|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
10908779|NCT00605475|BG009|Baseline|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
10908780|NCT00605475|BG010|Baseline|Total|Total of all reporting groups
10908781|NCT00605475|FG000|Participant Flow|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
10908782|NCT00605475|FG001|Participant Flow|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
10908783|NCT00605475|FG002|Participant Flow|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
10908784|NCT00605475|FG003|Participant Flow|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
10908785|NCT00605475|FG004|Participant Flow|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
10908786|NCT00605475|FG005|Participant Flow|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
10908787|NCT00605475|FG006|Participant Flow|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
10908788|NCT00605475|FG007|Participant Flow|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
10908789|NCT00605475|FG008|Participant Flow|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
10908790|NCT00605475|FG009|Participant Flow|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
10908791|NCT00605475|OG000|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
10908792|NCT00605475|OG001|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
10908793|NCT00605475|OG002|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
10908794|NCT00605475|OG003|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
10908795|NCT00605475|OG004|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
10908796|NCT00605475|OG005|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
10908797|NCT00605475|OG006|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
10908798|NCT00605475|OG001|Outcome|Cohort 2:Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
10908799|NCT00605475|OG005|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
10908800|NCT00605475|OG005|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. ingle dose IV infusion of Placebo
10908801|NCT00605475|OG005|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
10908802|NCT00605475|OG005|Outcome|Pooled (Cohort 3and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
10908803|NCT00605475|OG006|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
10908804|NCT00605475|OG006|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
10908805|NCT00605475|OG005|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo of cohort 3 and 4. Single dose IV infusion of Placebo
10908806|NCT00605475|OG005|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
10908807|NCT00605475|OG003|Outcome|Cohort 3:Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
10908808|NCT00605475|OG004|Outcome|Cohort 3:Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
10908809|NCT00605475|OG005|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
10908810|NCT00605475|OG005|Outcome|Pooled (Cohort 3 and 4) : Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
10908811|NCT00605475|OG006|Outcome|Cohort 4: Anakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
10908812|NCT00605475|OG000|Outcome|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
10908813|NCT00605475|OG001|Outcome|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
10908814|NCT00605475|OG002|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
10908815|NCT00605475|OG003|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
10908816|NCT00605475|OG004|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
10908817|NCT00605475|OG005|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
10908818|NCT00605475|OG006|Outcome|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
10908819|NCT00605475|OG007|Outcome|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
10908820|NCT00605475|OG008|Outcome|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
10908821|NCT00605475|OG009|Outcome|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
10908822|NCT00605475|EG000|Reported Event|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
10908823|NCT00605475|EG001|Reported Event|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
10908824|NCT00605475|EG002|Reported Event|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
10908825|NCT00605475|EG003|Reported Event|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
10908826|NCT00605475|EG004|Reported Event|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
10908827|NCT00605475|EG005|Reported Event|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
10908828|NCT00605475|EG006|Reported Event|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
10908829|NCT00605475|EG007|Reported Event|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
10908830|NCT00605475|EG008|Reported Event|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
10908831|NCT00605475|EG009|Reported Event|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
10908832|NCT00605540|BG000|Baseline|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
10908833|NCT00605540|FG000|Participant Flow|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
10908834|NCT00605540|OG000|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
10908835|NCT00605540|EG000|Reported Event|Chronic Obstructive Pulmonary Disease|
10908836|NCT00605566|BG000|Baseline|Sorafenib Plus Cyclophosphamide|"Patients will receive sorafenib and cyclophosphamide.~sorafenib and cyclophosphamide: During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After run-in period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally."
10908837|NCT00605566|FG000|Participant Flow|Sorafenib and Cyclophosphamide|"Patients will receive sorafenib and cyclophosphamide.~sorafenib and cyclophosphamide: During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After run-in period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally."
10908838|NCT00605566|OG000|Outcome|Sorafenib and Cyclophosphamide|"Patients will receive sorafenib and cyclophosphamide.~sorafenib and cyclophosphamide: During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After run-in period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally."
10908839|NCT00605566|EG000|Reported Event|Sorafenib Plus Cyclophosphamide|"Patients will receive sorafenib and cyclophosphamide.~sorafenib and cyclophosphamide: During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After run-in period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally."
10908840|NCT00605644|BG000|Baseline|Placebo|"Placebo~Placebo: Placebo"
10908841|NCT00605644|BG001|Baseline|150 mg|"MOA-728~MOA-728: Oral Capsules"
10908842|NCT00605644|BG002|Baseline|300 mg|"MOA-728~MOA-728: Oral Capsules"
11173088|NCT02013791|FG004|Participant Flow|Stage 1 Cohort 2|Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
11173089|NCT02013791|FG005|Participant Flow|Stage 1 Cohort 6B|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
11173090|NCT02013791|FG006|Participant Flow|Stage 1 Cohort 6D|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
10908843|NCT00605644|BG003|Baseline|450 mg|"MOA-728~MOA-728: Oral Capsules"
10908844|NCT00605644|BG004|Baseline|600 mg|"MOA-728~MOA-728: Oral Capsules"
10908845|NCT00605644|BG005|Baseline|Total|Total of all reporting groups
11173091|NCT02013791|FG007|Participant Flow|Stage 1 Cohort 6A|Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
11173092|NCT02013791|FG008|Participant Flow|Stage 1 Cohort 1|Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
10908846|NCT00605644|FG000|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
10908847|NCT00605644|FG001|Participant Flow|150 mg|"MOA-728~MOA-728: Oral Capsules"
10908848|NCT00605644|FG002|Participant Flow|300 mg|"MOA-728~MOA-728: Oral Capsules"
10908849|NCT00605644|FG003|Participant Flow|450 mg|"MOA-728~MOA-728: Oral Capsules"
10908850|NCT00605644|FG004|Participant Flow|600 mg|"MOA-728~MOA-728: Oral Capsules"
10908851|NCT00605644|OG000|Outcome|Placebo|"Placebo~Placebo: Placebo"
10908852|NCT00605644|OG001|Outcome|150 mg|"MOA-728~MOA-728: Oral Capsules"
10908853|NCT00605644|OG002|Outcome|300 mg|"MOA-728~MOA-728: Oral Capsules"
10908854|NCT00605644|OG003|Outcome|450 mg|"MOA-728~MOA-728: Oral Capsules"
10908855|NCT00605644|OG004|Outcome|600 mg|"MOA-728~MOA-728: Oral Capsules"
10908856|NCT00605644|EG000|Reported Event|Placebo|"Placebo~Placebo: Placebo"
10908857|NCT00605644|EG001|Reported Event|150 mg|"MOA-728~MOA-728: Oral Capsules"
11173093|NCT02013791|OG000|Outcome|Stage 1 Cohort 5A|Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
11173094|NCT02013791|OG001|Outcome|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
11173095|NCT02013791|OG002|Outcome|Stage 1 Cohort 6C|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
11173096|NCT02013791|OG003|Outcome|Stage 1 Cohort 3|Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
11173097|NCT02013791|OG004|Outcome|Stage 1 Cohort 2|Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
11173098|NCT02013791|OG005|Outcome|Stage 1 Cohort 6B|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
11173099|NCT02013791|OG006|Outcome|Stage 1 Cohort 6D|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
11173100|NCT02013791|OG007|Outcome|Stage 1 Cohort 6A|Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
11173101|NCT02013791|OG008|Outcome|Stage 1 Cohort 1|Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
11173102|NCT02013791|OG000|Outcome|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
11173103|NCT02013791|EG000|Reported Event|Stage 1 Cohort 5A|Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
10908858|NCT00605644|EG002|Reported Event|300 mg|"MOA-728~MOA-728: Oral Capsules"
10908859|NCT00605644|EG003|Reported Event|450 mg|"MOA-728~MOA-728: Oral Capsules"
10908860|NCT00605644|EG004|Reported Event|600 mg|"MOA-728~MOA-728: Oral Capsules"
10908861|NCT00605657|BG000|Baseline|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
10908862|NCT00605657|FG000|Participant Flow|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
10908863|NCT00605657|OG000|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
10908864|NCT00605657|EG000|Reported Event|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
10908865|NCT00605696|BG000|Baseline|Early Insulin Group|"Participants will receive IIT within 6-12 hours after presenting to ED.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
10908866|NCT00605696|BG001|Baseline|Control Group|"Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
10908867|NCT00605696|BG002|Baseline|Total|Total of all reporting groups
10908868|NCT00605696|FG000|Participant Flow|Early Insulin Group|Participants will receive insulin to target glucose of 80-110 mg/dl within 6-12 hours after presenting to ED for up to 48 hours after admission to the ICU.
10908869|NCT00605696|FG001|Participant Flow|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission.
10908870|NCT00605696|OG000|Outcome|Early Insulin Group|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) in the ED and after ICU admission for up to 48 hours.
10908871|NCT00605696|OG001|Outcome|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
10908872|NCT00605696|EG000|Reported Event|Early Insulin Group|"Participants will receive IIT within 6-12 hours after presenting to ED.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
10908873|NCT00605696|EG001|Reported Event|Control Group|"Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
10908874|NCT00605722|BG000|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
10908875|NCT00605722|FG000|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
10908876|NCT00605722|OG000|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
10908877|NCT00605722|EG000|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
10908878|NCT00605813|BG000|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
10908879|NCT00605813|FG000|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
10908880|NCT00605813|OG000|Outcome|Sertraline Hydrochloride|Participants who took Sertraline according to Japanese Package Insert
10908881|NCT00605813|OG000|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
10908882|NCT00605813|OG000|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
10908883|NCT00605813|OG001|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
10908884|NCT00605813|OG000|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
10908885|NCT00605813|OG001|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
10908886|NCT00605813|OG000|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
10908887|NCT00605813|OG001|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
10908888|NCT00605813|OG000|Outcome|Past History of Intentional Suicidal Ideation|Participants with past history of intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
10908889|NCT00605813|OG001|Outcome|Present History of Intentional Suicidal Ideation|Participants with present intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
10908890|NCT00605813|EG000|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert
10908891|NCT00605826|BG000|Baseline|NashaDx/Fecal|NashaDx/Fecal - 4 syringes each containing 1 mL of product
10908892|NCT00605826|BG001|Baseline|Sham|Sham - 4 empty syringes
10908893|NCT00605826|BG002|Baseline|Total|Total of all reporting groups
10908894|NCT00605826|FG000|Participant Flow|NashaDx/Fecal|NashaDx/Fecal - 4 syringes each containing 1 mL of product
10908895|NCT00605826|FG001|Participant Flow|Sham|Sham - 4 empty syringes
10908896|NCT00605826|OG000|Outcome|NashaDx/Fecal|NashaDx/Fecal - 4 syringes each containing 1 mL of product
10908897|NCT00605826|OG001|Outcome|Sham|Sham - 4 empty syringes
10908898|NCT00605826|OG000|Outcome|NASHA/Dx Fecal|NASHA/Dx Fecal - 4 syringes each containing 1 mL of product
10908899|NCT00605826|EG000|Reported Event|Overall|Adverse events were assessed overall and not by randomized treatment group
10908900|NCT00605839|BG000|Baseline|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
10908901|NCT00605839|BG001|Baseline|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
10908902|NCT00605839|BG002|Baseline|Usual Care|Usual care, without cell phone or glucopak
10908903|NCT00605839|BG003|Baseline|Total|Total of all reporting groups
11233563|NCT02429115|OG000|Outcome|Face-to-face Peer Mentoring Patients|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
10908904|NCT00605839|FG000|Participant Flow|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. Participants use the experimental device and are actively monitored by the clinic.
10908905|NCT00605839|FG001|Participant Flow|Cell Phone Only|Cell phone only. Participants are given cell phones and encouraged to keep in contact with the clinic.
10908906|NCT00605839|FG002|Participant Flow|Usual Care|Usual care, without Glucopak or cell phones.
10908907|NCT00605839|OG000|Outcome|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
10908908|NCT00605839|OG001|Outcome|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
10908909|NCT00605839|OG002|Outcome|Usual Care|Usual care, without cell phone or glucopak
10908910|NCT00605839|EG000|Reported Event|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
11233564|NCT02429115|OG001|Outcome|Online Peer Mentoring Patients|"Will receive 6 months of online peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233565|NCT02429115|OG002|Outcome|Control Patients|Will not receive peer mentoring.
11233566|NCT02429115|OG000|Outcome|Face-to-face Peer Mentoring|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
10908911|NCT00605839|EG001|Reported Event|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
10908912|NCT00605839|EG002|Reported Event|Usual Care|Usual care, without cell phone or glucopak
10908913|NCT00605865|BG000|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
10908914|NCT00605865|FG000|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
10908915|NCT00605865|OG000|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
10908916|NCT00605865|OG000|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
10908917|NCT00605865|OG001|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
10908918|NCT00605865|OG000|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
10908919|NCT00605865|OG001|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
10908920|NCT00605865|OG000|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
10908921|NCT00605865|OG001|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
10908922|NCT00605865|OG000|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
10908923|NCT00605865|OG001|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
10908924|NCT00605865|OG000|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
10908925|NCT00605865|OG001|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
10908926|NCT00605865|OG002|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
10908927|NCT00605865|OG003|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
10908928|NCT00605865|OG004|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
10908929|NCT00605865|OG000|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
10908930|NCT00605865|OG001|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
11233567|NCT02429115|OG001|Outcome|Online Peer Mentoring|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
10908931|NCT00605865|OG000|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
10908932|NCT00605865|OG001|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
11233568|NCT02429115|OG002|Outcome|Control|Will not receive peer mentoring.
10908933|NCT00605865|OG000|Outcome|Mild|Participants whose target disease are mild and who took Sertraline according to Japanese Package Insert
10908934|NCT00605865|OG001|Outcome|Moderate|Participants whose target disease are moderate and who took Sertraline according to Japanese Package Insert
10908935|NCT00605865|OG002|Outcome|Severe|Participants whose target disease are severe and who took Sertraline according to Japanese Package Insert
10908936|NCT00605865|OG000|Outcome|With History of Treatment Prior to Sertraline|Participants with history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
10908937|NCT00605865|OG001|Outcome|Without History of Treatment Prior to Sertraline|Participants without history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
11233569|NCT02429115|EG000|Reported Event|Face-to-face Peer Mentoring Patients|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
10908938|NCT00605865|OG000|Outcome|Inpatient|Participants as inpatients who took Sertraline according to Japanese Package Insert
10908939|NCT00605865|OG001|Outcome|Outpatient|Participants as outpatients who took Sertraline according to Japanese Package Insert
10908940|NCT00605865|OG000|Outcome|Under 18 Years of Age|Participants under 18 years of age who took Sertraline according to Japanese Package Insert
10908941|NCT00605865|OG001|Outcome|18-44 Years of Age|Participants from 18 to 44 years of age who took Sertraline according to Japanese Package Insert
10908942|NCT00605865|OG002|Outcome|45-64 Years of Age|Participants from 45 to 64 years of age who took Sertraline according to Japanese Package Insert
10908943|NCT00605865|OG003|Outcome|Over 65 Years of Age|Participants over 65 years of age who took Sertraline according to Japanese Package Insert
10908944|NCT00605865|EG000|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert. All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
10908945|NCT00605904|BG000|Baseline|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
10908946|NCT00605904|BG001|Baseline|Placebo|Subjects received 3 tablets of placebo three times daily
10908947|NCT00605904|BG002|Baseline|Total|Total of all reporting groups
10908948|NCT00605904|FG000|Participant Flow|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
10908949|NCT00605904|FG001|Participant Flow|Placebo|Subjects received 3 tablets of placebo three times daily
10908950|NCT00605904|OG000|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
10908951|NCT00605904|OG001|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
10908952|NCT00605904|EG000|Reported Event|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
10908953|NCT00605904|EG001|Reported Event|Placebo|Subjects received 3 tablets of placebo three times daily
10908954|NCT00605917|BG000|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
10908955|NCT00605917|FG000|Participant Flow|Sertraline|"Participants taking Sertraline according to Japanese Package Insert; This study is Special Investigation of JZOLOFT for panic disorder and one of conditions of this study is patients who are diagnosed with panic disorder. So, all of participants in this study are panic disorder patients."
10908956|NCT00605917|OG000|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
10908957|NCT00605917|OG000|Outcome|25mg|Participants whose starting dose were 25mg
10908958|NCT00605917|OG001|Outcome|50mg|Participants whose starting dose were 50mg
10908959|NCT00605917|OG002|Outcome|75mg|Participants whose starting dose were 75mg
10908960|NCT00605917|OG003|Outcome|100mg|Participants whose starting dose were 100mg
10908961|NCT00605917|OG004|Outcome|Other Than Those Above|Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
10908962|NCT00605917|OG000|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
10908963|NCT00605917|OG001|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
10908964|NCT00605917|OG000|Outcome|With Family History|Participants with family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
10908965|NCT00605917|OG001|Outcome|Without Family History|Participants without family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
10908966|NCT00605917|OG000|Outcome|Don't Smoke at All|Participants who didn't smoke at all and who took Sertraline according to Japanese Package Insert
10908967|NCT00605917|OG001|Outcome|Used to Smoke But do Not Then|Participants who used to smoke but didn't then and who took Sertraline according to Japanese Package Insert
10908968|NCT00605917|OG002|Outcome|Smoke Then|Participants who smoke then and who took Sertraline according to Japanese Package Insert
10908969|NCT00605917|OG000|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
10908970|NCT00605917|OG001|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
10908971|NCT00605917|OG000|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
10908972|NCT00605917|OG001|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
10908973|NCT00605917|OG000|Outcome|With History of Treatment|Participants with history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
10908974|NCT00605917|OG001|Outcome|Without History of Treatment|Participants without history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
10908975|NCT00605917|OG000|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
10908976|NCT00605917|OG001|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
10908977|NCT00605917|OG002|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
10908978|NCT00605917|OG003|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
10908979|NCT00605917|OG004|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
10908980|NCT00605917|OG000|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
10908981|NCT00605917|OG001|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
10908982|NCT00605917|OG001|Outcome|Without Concomitrant|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
10908983|NCT00605917|OG000|Outcome|Didn't Drink Alcohol at All, and Had Never Drunk Alcohol|Participants who didn't drink alcohol at all, and had never drunk alcohol and who took Sertraline according to Japanese Package Insert
10908984|NCT00605917|OG001|Outcome|Drank Alcohol Very Occasionally|Participants who drank alcohol very occasionally and who took Sertraline according to Japanese Package Insert
10908985|NCT00605917|OG002|Outcome|Used to Drink Alcohol But Did Not Then|Participants who used to drink alcohol but did not then and who took Sertraline according to Japanese Package Insert
10908986|NCT00605917|OG003|Outcome|Drank Alcohol Moderately|Participants who drank alcohol moderately and who took Sertraline according to Japanese Package Insert
10908987|NCT00605917|OG004|Outcome|Drank Alcohol Every Day|Participants who drank alcohol every day and who took Sertraline according to Japanese Package Insert
10908988|NCT00605917|EG000|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert.The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
10908989|NCT00606008|BG000|Baseline|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
10908990|NCT00606008|FG000|Participant Flow|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
10908991|NCT00606008|OG000|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
10908992|NCT00606008|OG001|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
10908993|NCT00606008|OG002|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
10908994|NCT00606008|EG000|Reported Event|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
10908995|NCT00606008|EG001|Reported Event|AA Cohort Patients|Recurrent glioblastoma (GB) patients
10908996|NCT00606008|EG002|Reported Event|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
10908997|NCT00606021|BG000|Baseline|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
10908998|NCT00606021|BG001|Baseline|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
10908999|NCT00606021|BG002|Baseline|Total|Total of all reporting groups
10909000|NCT00606021|FG000|Participant Flow|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
10909001|NCT00606021|FG001|Participant Flow|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 (mg/m²), IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
10909002|NCT00606021|FG002|Participant Flow|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
10909003|NCT00606021|OG000|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
10909004|NCT00606021|OG001|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
10909005|NCT00606021|OG002|Outcome|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
10909006|NCT00606021|EG000|Reported Event|Pemetrexed Plus Best Supportive Care - Maintenance Phase|Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
10909007|NCT00606021|EG001|Reported Event|Best Supportive Care - Maintenance Phase|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
10909008|NCT00606021|EG002|Reported Event|Pemetrexed + Cisplatin - Induction Phase|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles.
10909009|NCT00606034|BG000|Baseline|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
10909010|NCT00606034|FG000|Participant Flow|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
10909011|NCT00606034|OG000|Outcome|All Subjects Using U-500 Regular Insulin Via Omnipod|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
10909012|NCT00606034|OG000|Outcome|All Subjects|
10909013|NCT00606034|OG000|Outcome|All Subjects|All subjects will receive the IDRSQ at baseline and at Week 52
10909014|NCT00606034|EG000|Reported Event|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
10909015|NCT00606047|BG000|Baseline|Asymptomatic Patients|"Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI).~Magnetic resonance imaging (MRI): Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints."
10909016|NCT00606047|FG000|Participant Flow|Asymptomatic Patients|"Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI).~Magnetic resonance imaging (MRI): Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints."
10909017|NCT00606047|OG000|Outcome|Asymptomatic Patients|"Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI).~Magnetic resonance imaging (MRI): Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints."
10909018|NCT00606047|EG000|Reported Event|Asymptomatic Patients|"Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI).~Magnetic resonance imaging (MRI): Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints."
10909019|NCT00606086|BG000|Baseline|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
10909020|NCT00606086|BG001|Baseline|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
10909021|NCT00606086|BG002|Baseline|Total|Total of all reporting groups
10909022|NCT00606086|FG000|Participant Flow|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
10909023|NCT00606086|FG001|Participant Flow|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
10909024|NCT00606086|OG000|Outcome|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
10909025|NCT00606086|OG001|Outcome|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
10915110|NCT00634088|FG002|Participant Flow|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
11233570|NCT02429115|EG001|Reported Event|Online Peer Mentoring Patients|"Will receive 6 months of online peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
11233571|NCT02429115|EG002|Reported Event|Control Patients|Will not receive peer mentoring.
11233572|NCT02429115|EG003|Reported Event|Face-to-face Peer Mentoring Caregivers|"Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
10909026|NCT00606086|EG000|Reported Event|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
10909027|NCT00606086|EG001|Reported Event|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
10909028|NCT00606138|BG000|Baseline|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
10909029|NCT00606138|BG001|Baseline|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
10909030|NCT00606138|BG002|Baseline|Total|Total of all reporting groups
10909031|NCT00606138|FG000|Participant Flow|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
10909032|NCT00606138|FG001|Participant Flow|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
10909033|NCT00606138|OG000|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
10909034|NCT00606138|OG001|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
10909035|NCT00606138|EG000|Reported Event|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
10909036|NCT00606138|EG001|Reported Event|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
10909037|NCT00606177|BG000|Baseline|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
10909038|NCT00606177|BG001|Baseline|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
10909039|NCT00606177|BG002|Baseline|Total|Total of all reporting groups
10909040|NCT00606177|FG000|Participant Flow|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
10909041|NCT00606177|FG001|Participant Flow|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
10909042|NCT00606177|OG000|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
10909043|NCT00606177|OG001|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
10909044|NCT00606177|EG000|Reported Event|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
10909045|NCT00606177|EG001|Reported Event|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
10909046|NCT00606229|BG000|Baseline|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
10909047|NCT00606229|FG000|Participant Flow|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
10909048|NCT00606229|OG000|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
10909049|NCT00606229|EG000|Reported Event|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
10909050|NCT00606281|BG000|Baseline|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
10909051|NCT00606281|BG001|Baseline|Placebo|Subjects were administered placebo once daily for 21 days.
10909052|NCT00606281|BG002|Baseline|Total|Total of all reporting groups
10909053|NCT00606281|FG000|Participant Flow|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
10909054|NCT00606281|FG001|Participant Flow|Placebo|Subjects were administered placebo once daily for 21 days.
10909055|NCT00606281|OG000|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
10909056|NCT00606281|OG001|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
10909057|NCT00606281|EG000|Reported Event|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
10909058|NCT00606281|EG001|Reported Event|Placebo|Subjects were administered placebo once daily for 21 days.
10915111|NCT00634088|FG003|Participant Flow|Ixabepilone+ Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
10915112|NCT00634088|OG000|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
10909059|NCT00606294|BG000|Baseline|Cohort 1 (Closed to Accrual)|Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
10909060|NCT00606294|BG001|Baseline|Cohort 2 (Closed to Accrual)|Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
10909061|NCT00606294|BG002|Baseline|Total|Total of all reporting groups
10909062|NCT00606294|FG000|Participant Flow|Cohort 1 (Closed to Accrual)|Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
10909063|NCT00606294|FG001|Participant Flow|Cohort 2 (Closed to Accrual)|Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
10909064|NCT00606294|OG000|Outcome|Cohort 1 (Closed to Accrual)|Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
10909065|NCT00606294|OG001|Outcome|Cohort 2 (Closed to Accrual)|Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
10909066|NCT00606294|EG000|Reported Event|Cohort 1 (Closed to Accrual)|Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
10909067|NCT00606294|EG001|Reported Event|Cohort 2 (Closed to Accrual)|Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
10909068|NCT00606307|BG000|Baseline|ITF2357|"Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.~ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration."
10909069|NCT00606307|FG000|Participant Flow|ITF2357|"Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.~ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration."
10909070|NCT00606307|OG000|Outcome|ITF2357|"Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.~ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration."
10909071|NCT00606307|EG000|Reported Event|ITF2357|"Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.~ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration."
10909072|NCT00606320|BG000|Baseline|Arupiprazole|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
10909073|NCT00606320|FG000|Participant Flow|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
10909074|NCT00606320|OG000|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
10909075|NCT00606320|EG000|Reported Event|Aripiprazole|Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
10909076|NCT00606489|BG000|Baseline|Placebo (250 Milliliters Normal Saline)|
10909077|NCT00606489|BG001|Baseline|800mg Intravenous Ibuprofen|
10909078|NCT00606489|BG002|Baseline|Total|Total of all reporting groups
10909079|NCT00606489|FG000|Participant Flow|Placebo (250 Milliliters Normal Saline)|
10909080|NCT00606489|FG001|Participant Flow|800mg Intravenous Ibuprofen|
10909081|NCT00606489|OG000|Outcome|Placebo (250 Milliliters Normal Saline)|
10909082|NCT00606489|OG001|Outcome|800mg Intravenous Ibuprofen|
11173104|NCT02013791|EG001|Reported Event|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
10909083|NCT00606489|EG000|Reported Event|Placebo (250 Milliliters Normal Saline)|
10909084|NCT00606489|EG001|Reported Event|800mg Intravenous Ibuprofen|
10909085|NCT00606502|BG000|Baseline|Pralatrexate|
10909086|NCT00606502|BG001|Baseline|Erlotinib|
10909087|NCT00606502|BG002|Baseline|Total|Total of all reporting groups
10909088|NCT00606502|FG000|Participant Flow|Pralatrexate|190 or 230 mg/m2 starting dose with increases or decreases to 150 to 270 mg/m2 per protocol, administered as an IV push over 3-5 minutes on days 1 and 15 of a 4-week cycle (ie, every 2 weeks)
10909089|NCT00606502|FG001|Participant Flow|Erlotinib|150 mg tablet taken orally daily
10909090|NCT00606502|OG000|Outcome|Pralatrexate|
10909091|NCT00606502|OG001|Outcome|Erlotinib|
10909092|NCT00606502|EG000|Reported Event|Pralatrexate|
10909093|NCT00606502|EG001|Reported Event|Erlotinib|
10909094|NCT00606554|BG000|Baseline|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
10909095|NCT00606554|BG001|Baseline|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
10909096|NCT00606554|BG002|Baseline|Total|Total of all reporting groups
10909097|NCT00606554|FG000|Participant Flow|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
10909098|NCT00606554|FG001|Participant Flow|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
10909099|NCT00606554|OG000|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
10909100|NCT00606554|OG001|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
10909101|NCT00606554|OG000|Outcome|Computer-assisted Weaning|"Group assigned to the computer-assisted weaning program~Computer-assisted weaning program: Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning."
10909102|NCT00606554|OG001|Outcome|Standard of Care Weaning|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Standard of Care weaning: Evidence-based standard of care weaning process."
10909103|NCT00606554|OG000|Outcome|Computer-assisted Weaning|Group assigned to the computer-assisted weaning program. Intervention Group
10909104|NCT00606554|OG001|Outcome|Standard of Care Weaning|Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
10909105|NCT00606554|EG000|Reported Event|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
10909106|NCT00606554|EG001|Reported Event|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
10909107|NCT00606580|BG000|Baseline|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
11173105|NCT02013791|EG002|Reported Event|Stage 1 Cohort 6C|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
11173106|NCT02013791|EG003|Reported Event|Stage 1 Cohort 3|Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
11173107|NCT02013791|EG004|Reported Event|Stage 1 Cohort 2|Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
11173108|NCT02013791|EG005|Reported Event|Stage 1 Cohort 6B|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
11173109|NCT02013791|EG006|Reported Event|Stage 1 Cohort 6D|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
11173110|NCT02013791|EG007|Reported Event|Stage 1 Cohort 6A|Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
10909108|NCT00606580|BG001|Baseline|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
10909109|NCT00606580|BG002|Baseline|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
10909110|NCT00606580|BG003|Baseline|Total|Total of all reporting groups
10909111|NCT00606580|FG000|Participant Flow|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
10909112|NCT00606580|FG001|Participant Flow|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
10909113|NCT00606580|FG002|Participant Flow|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
10909114|NCT00606580|OG000|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
10909115|NCT00606580|OG001|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
10909116|NCT00606580|OG002|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
10909117|NCT00606580|EG000|Reported Event|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
10909118|NCT00606580|EG001|Reported Event|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
10909119|NCT00606580|EG002|Reported Event|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
10909120|NCT00606593|BG000|Baseline|Patient Flow|The study consisted of a 2-4-week screening phase (including 2 consecutive screening polysomnography (PSG) nights on single blind placebo), a 4- to 8-week treatment phase, and a 28 day safety follow-up. The treatment phase immediately followed randomization and included 5 treatment periods, each consisting of 2 consecutive treatment PSG nights on the assigned study treatment separated by 5 to 12 days of washout. Subjects were randomized to one of 10 treatment sequences.
10909121|NCT00606593|FG000|Participant Flow|Treatment Sequence 200/100/P/50/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.
10909122|NCT00606593|FG001|Participant Flow|Treatment Sequence 100/50/200/25/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.
10909123|NCT00606593|FG002|Participant Flow|Treatment Sequence 50/25/100/P/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.
10909124|NCT00606593|FG003|Participant Flow|Treatment Sequence 25/P/50/200/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.
10909125|NCT00606593|FG004|Participant Flow|Treatment Sequence P/200/25/100/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.
10909126|NCT00606593|FG005|Participant Flow|Treatment Sequence 25/50/P/100/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.
11173111|NCT02013791|EG008|Reported Event|Stage 1 Cohort 1|Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
10909127|NCT00606593|FG006|Participant Flow|Treatment Sequence P/25/200/50/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.
10909128|NCT00606593|FG007|Participant Flow|Treatment Sequence 200/P/100/25/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.
11173112|NCT02013817|BG000|Baseline|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
11173113|NCT02013817|FG000|Participant Flow|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
11173114|NCT02013817|OG000|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
11173115|NCT02013817|EG000|Reported Event|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
11173116|NCT02013830|BG000|Baseline|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
11173117|NCT02013830|FG000|Participant Flow|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
10909129|NCT00606593|FG008|Participant Flow|Treatment Sequence 100/200/50/P/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.
10909130|NCT00606593|FG009|Participant Flow|Treatment Sequence 50/100/25/200/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.
10909131|NCT00606593|OG000|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
10909132|NCT00606593|OG001|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
10909133|NCT00606593|OG002|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
10909134|NCT00606593|OG003|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
10909135|NCT00606593|OG004|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
10909136|NCT00606593|EG000|Reported Event|Single-blind Placebo|Treatment administered during screening period
10909137|NCT00606593|EG001|Reported Event|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
10909138|NCT00606593|EG002|Reported Event|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
10909139|NCT00606593|EG003|Reported Event|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
10909140|NCT00606593|EG004|Reported Event|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
10909141|NCT00606593|EG005|Reported Event|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
10915113|NCT00634088|OG000|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
10915114|NCT00634088|OG001|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
10915115|NCT00634088|OG002|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
10915116|NCT00634088|OG003|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
10915117|NCT00634088|EG000|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for 21-day cycle.
10915118|NCT00634088|EG001|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
10915119|NCT00634088|EG002|Reported Event|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
10915120|NCT00634101|BG000|Baseline|Test (Narafilcon A)|Subjects randomized to receive the Test lens throughout the study
10915121|NCT00634101|BG001|Baseline|Control (Nelfilcon A)|Subjects randomized to receive the Control lens throughout the study
10915122|NCT00634101|BG002|Baseline|Total|Total of all reporting groups
10915123|NCT00634101|FG000|Participant Flow|Test (Narafilcon A)|Subjects randomized to receive the Test lens throughout the study
10915124|NCT00634101|FG001|Participant Flow|Control (Nelfilcon A)|Subjects randomized to receive the Control lens throughout the study
10915125|NCT00634101|OG000|Outcome|Test (Narafilcon A)|Subject that wore the Test lens throughout the study.
10915126|NCT00634101|OG001|Outcome|Control (Nelfilcon A)|Subject that wore the Control lens throughout the study.
10915127|NCT00634101|EG000|Reported Event|Test (Narafilcon A)|Subject that were dispensed the Test lens throughout the study.
10915128|NCT00634101|EG001|Reported Event|Control (Nelfilcon A)|Subject that were dispensed the Control lens throughout the study.
10915129|NCT00634114|BG000|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
10915130|NCT00634114|BG001|Baseline|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
10915131|NCT00634114|BG002|Baseline|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
10915132|NCT00634114|BG003|Baseline|Total|Total of all reporting groups
10915133|NCT00634114|FG000|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
10915134|NCT00634114|FG001|Participant Flow|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
10915135|NCT00634114|FG002|Participant Flow|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
11174238|NCT02020408|EG000|Reported Event|[11C]Raclopride, [11C]DASB, Amphetamine|"healthy control women (CW);~women recovered from restricting type anorexia nervosa (REC AN);~women recovered from bulimic type anorexia nervosa (REC AN-BN)~women recovered from from bulimia nervosa (REC BN)"
10915136|NCT00634114|OG000|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
10915137|NCT00634114|OG001|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
10915138|NCT00634114|OG002|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
10915139|NCT00634114|EG000|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
10915140|NCT00634114|EG001|Reported Event|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
10915141|NCT00634114|EG002|Reported Event|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
11174239|NCT02020512|BG000|Baseline|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
10909142|NCT00606632|BG000|Baseline|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
10909143|NCT00606632|FG000|Participant Flow|PET/CT Versus CT|PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.
10909144|NCT00606632|OG000|Outcome|Sensitivity CT|"Sensitivity of diagnostic CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.~The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
10909145|NCT00606632|OG001|Outcome|Sensitivity PET/CT|"Sensitivity of 124I-cG250 PET/CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.~The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
10909146|NCT00606632|OG002|Outcome|Specificity PET/CT|"Specificity of 124I-cG250 PET/CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.~The specificity of refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
10909147|NCT00606632|OG003|Outcome|Specificity CT|"Specificity of CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.~The specificity refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
10909148|NCT00606632|OG000|Outcome|PET/CT|Patients with 124I-cG250 PET/CT evaluable images.
10909149|NCT00606632|OG001|Outcome|Diagnostic CT|Patients with diagnostic CT images.
10909150|NCT00606632|EG000|Reported Event|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
10909151|NCT00606684|BG000|Baseline|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909152|NCT00606684|BG001|Baseline|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909153|NCT00606684|BG002|Baseline|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909154|NCT00606684|BG003|Baseline|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909155|NCT00606684|BG004|Baseline|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909156|NCT00606684|BG005|Baseline|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909157|NCT00606684|BG006|Baseline|Total|Total of all reporting groups
10909158|NCT00606684|FG000|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning from the novel dual strip dry powder inhaler. In addition, all participants were provided supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used asneeded throughout the study.
10909159|NCT00606684|FG001|Participant Flow|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909160|NCT00606684|FG002|Participant Flow|GW642444M 3 µg|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909161|NCT00606684|FG003|Participant Flow|GW642444M 6.25 µg|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909162|NCT00606684|FG004|Participant Flow|GW642444M 12.5 µg|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909163|NCT00606684|FG005|Participant Flow|GW642444M 25 µg|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909164|NCT00606684|FG006|Participant Flow|GW642444M 50 µg|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909165|NCT00606684|OG000|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909166|NCT00606684|OG001|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909167|NCT00606684|OG002|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
11174240|NCT02020512|FG000|Participant Flow|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
10909168|NCT00606684|OG003|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909169|NCT00606684|OG004|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909170|NCT00606684|OG005|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909171|NCT00606684|EG000|Reported Event|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909172|NCT00606684|EG001|Reported Event|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909173|NCT00606684|EG002|Reported Event|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909174|NCT00606684|EG003|Reported Event|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909175|NCT00606684|EG004|Reported Event|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909176|NCT00606684|EG005|Reported Event|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
10909177|NCT00606801|BG000|Baseline|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
10909178|NCT00606801|BG001|Baseline|Placebo|Placebo given for 10 days.
10909179|NCT00606801|BG002|Baseline|Total|Total of all reporting groups
10909180|NCT00606801|FG000|Participant Flow|Placebo|Placebo given for 10 days.
10909181|NCT00606801|FG001|Participant Flow|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
10909182|NCT00606801|OG000|Outcome|Placebo|Measures on placebo group.
10909183|NCT00606801|OG001|Outcome|Galantamine|Measures on Galantamine group.
10909184|NCT00606801|OG000|Outcome|Placebo|Measures on the placebo group.
10909185|NCT00606801|OG001|Outcome|Galantamine|Measures on the Galantamine group.
10909186|NCT00606801|OG000|Outcome|Placebo|Measures in placebo group.
10909187|NCT00606801|OG001|Outcome|Galantamine|Measures in galantamine group.
10909188|NCT00606801|EG000|Reported Event|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
10909189|NCT00606801|EG001|Reported Event|Placebo|Placebo given for 10 days.
10909190|NCT00606892|BG000|Baseline|Entire Study Population|Includes all subjects who completed the study. (The total number of subjects who were enrolled in both arms of the study.)
10909191|NCT00606892|FG000|Participant Flow|Placebo First, Then Varenicline|Subject received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg). After a minimum washout period of 5 days,then subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).
10909192|NCT00606892|FG001|Participant Flow|Varenicline First, Then Placebo|Subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).After a minimum of washout period of 5 days, then subjects received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg).
10909193|NCT00606892|OG000|Outcome|Placebo, Pre-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and prior to the nicotine infusions.
10909194|NCT00606892|OG001|Outcome|Placebo, Post-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and 30 minutes after the nicotine infusions.
10909195|NCT00606892|OG002|Outcome|Varenicline, Pre-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition prior to the nicotine infusions.
10909196|NCT00606892|OG003|Outcome|Varenicline, Post-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition and 30 minutes after the nicotine infusions.
10909197|NCT00606892|OG000|Outcome|Placebo|The mean cotinine levels for subjects under the placebo condition.
10909198|NCT00606892|OG001|Outcome|Varenicline (1 mg)|The mean cotinine levels for subjects under the varenicline condition.
10909199|NCT00606892|OG000|Outcome|Placebo/ Low Dose Nictoine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the placebo condition.
11174241|NCT02020512|OG000|Outcome|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
10909200|NCT00606892|OG001|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the placebo condition.
10909201|NCT00606892|OG002|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the placebo condition.
10909202|NCT00606892|OG003|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the varenicline condition.
10909203|NCT00606892|OG004|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the varenicline condition.
10909204|NCT00606892|OG005|Outcome|Varenicline/ High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the varenicline condition.
10909205|NCT00606892|OG000|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per70kg) infusion under the placebo condition.
10909206|NCT00606892|OG001|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the placebo condition.
10909207|NCT00606892|OG002|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the placebo condition.
10909208|NCT00606892|OG003|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
10909209|NCT00606892|OG004|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
10909210|NCT00606892|OG005|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
10909211|NCT00606892|OG000|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the placebo condition.
10909212|NCT00606892|OG001|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the placebo condition.
10909213|NCT00606892|OG002|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the placebo condition.
10909214|NCT00606892|OG003|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
10909215|NCT00606892|OG004|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
10909216|NCT00606892|OG005|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
10909217|NCT00606892|EG000|Reported Event|Placebo First, Then Varenicline, First Intervention|Subjects received a placebo tablet once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
10909218|NCT00606892|EG001|Reported Event|Varenicline First, Then Placebo, First Intervention|Subjects received varenicline once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
10909219|NCT00606892|EG002|Reported Event|Adaptation - Placebo First, Then Varenicline|Subjects randomized to the 'Placebo first' condition participated in a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability prior to the study medication intervention.
10909220|NCT00606892|EG003|Reported Event|Adaptation - Varenicline First, Then Placebo|Subjects randomized to the 'Varenicline first' condition first received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability before receiving the study medication.
10909221|NCT00606892|EG004|Reported Event|Placebo First, Then Varenicline, Second Intervention|Subjects crossed-over from the first intervention and received varenicline once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
11174242|NCT02020512|EG000|Reported Event|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
10909222|NCT00606892|EG005|Reported Event|Varenicline First, Then Placebo, Second Intervention|Subjects crossed-over from the first intervention (varenicline) and received placebo once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
10909223|NCT00606905|BG000|Baseline|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
10909224|NCT00606905|BG001|Baseline|Normal Saline|equivalent volume of normal saline
10909225|NCT00606905|BG002|Baseline|Total|Total of all reporting groups
10909226|NCT00606905|FG000|Participant Flow|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
10909227|NCT00606905|FG001|Participant Flow|Normal Saline|equivalent volume of normal saline
10909228|NCT00606905|OG000|Outcome|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
10909229|NCT00606905|OG001|Outcome|Normal Saline|equivalent volume of normal saline
10909230|NCT00606905|EG000|Reported Event|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
10909231|NCT00606905|EG001|Reported Event|Normal Saline|equivalent volume of normal saline
10909232|NCT00606931|BG000|Baseline|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
10909233|NCT00606931|FG000|Participant Flow|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
10909234|NCT00606931|OG000|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
10909235|NCT00606931|EG000|Reported Event|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
10909236|NCT00606944|BG000|Baseline|Control Group|traditional, conventional care group
10909237|NCT00606944|BG001|Baseline|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
10909238|NCT00606944|BG002|Baseline|Total|Total of all reporting groups
10909239|NCT00606944|FG000|Participant Flow|Control Group|traditional, conventional care group
10909240|NCT00606944|FG001|Participant Flow|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
10909241|NCT00606944|OG000|Outcome|Control Group|traditional, conventional care group
10909242|NCT00606944|OG001|Outcome|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
10909243|NCT00606944|EG000|Reported Event|Control Group|traditional, conventional care group
10909244|NCT00606944|EG001|Reported Event|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
10909245|NCT00607022|BG000|Baseline|Immediate Load|"immediate load of dental implant based on the bone quality determined by the insertion torque value~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909246|NCT00607022|BG001|Baseline|6 Week Load|"delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909247|NCT00607022|BG002|Baseline|12 Week Load|"traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909248|NCT00607022|BG003|Baseline|Total|Total of all reporting groups
10909249|NCT00607022|FG000|Participant Flow|Immediate Load|"immediate load of dental implant based on the bone quality determined by the insertion torque value~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909250|NCT00607022|FG001|Participant Flow|6 Week Load|"delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909251|NCT00607022|FG002|Participant Flow|12 Week Load|"traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909252|NCT00607022|OG000|Outcome|Immediate Load|"immediate load of dental implant based on the bone quality determined by the insertion torque value~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909253|NCT00607022|OG001|Outcome|6 Week Load|"delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909254|NCT00607022|OG002|Outcome|12 Week Load|"traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
11173118|NCT02013830|OG000|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
10909255|NCT00607022|EG000|Reported Event|Immediate Load|"immediate load of dental implant based on the bone quality determined by the insertion torque value~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909256|NCT00607022|EG001|Reported Event|6 Week Load|"delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909257|NCT00607022|EG002|Reported Event|12 Week Load|"traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.~dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach."
10909258|NCT00607048|BG000|Baseline|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
10909259|NCT00607048|BG001|Baseline|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
10909260|NCT00607048|BG002|Baseline|Total|Total of all reporting groups
10909261|NCT00607048|FG000|Participant Flow|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
10909262|NCT00607048|FG001|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
10909263|NCT00607048|FG002|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
10909264|NCT00607048|FG003|Participant Flow|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
10909265|NCT00607048|FG004|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
10909266|NCT00607048|FG005|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
10909267|NCT00607048|OG000|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
10909268|NCT00607048|OG001|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
10909269|NCT00607048|OG002|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
10909270|NCT00607048|OG003|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
10909271|NCT00607048|OG004|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
10909272|NCT00607048|OG005|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
10909273|NCT00607048|OG000|Outcome|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
10909274|NCT00607048|OG001|Outcome|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
10909275|NCT00607048|EG000|Reported Event|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
10909276|NCT00607048|EG001|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
10909277|NCT00607048|EG002|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
10909278|NCT00607048|EG003|Reported Event|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
10909279|NCT00607048|EG004|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
10909280|NCT00607048|EG005|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
10909281|NCT00607087|BG000|Baseline|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
10909282|NCT00607087|BG001|Baseline|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
10909283|NCT00607087|BG002|Baseline|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
10909284|NCT00607087|BG003|Baseline|Total|Total of all reporting groups
10909285|NCT00607087|FG000|Participant Flow|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
10909286|NCT00607087|FG001|Participant Flow|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
10909287|NCT00607087|FG002|Participant Flow|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
10909288|NCT00607087|OG000|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
11174243|NCT02020577|BG000|Baseline|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
10909289|NCT00607087|OG001|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
10909290|NCT00607087|OG002|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
10909291|NCT00607087|EG000|Reported Event|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
10909292|NCT00607087|EG001|Reported Event|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
10909293|NCT00607087|EG002|Reported Event|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
10909294|NCT00607113|BG000|Baseline|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
10909295|NCT00607113|BG001|Baseline|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
10909296|NCT00607113|BG002|Baseline|Total|Total of all reporting groups
10909297|NCT00607113|FG000|Participant Flow|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
10909298|NCT00607113|FG001|Participant Flow|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
10909299|NCT00607113|OG000|Outcome|Avastin|Cycle 1 (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV) or RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
10909300|NCT00607113|OG001|Outcome|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
10909301|NCT00607113|EG000|Reported Event|Avastin + RAD001|One agent (RAD001 or Avastin) then adding the second agent (Avastin or RAD001): Avastin 15 mg/kg intravenous (IV) every 3 weeks + RAD001 10 mg orally daily for 21 Days
10909302|NCT00607126|BG000|Baseline|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
10909303|NCT00607126|BG001|Baseline|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
10909304|NCT00607126|BG002|Baseline|Total|Total of all reporting groups
10909305|NCT00607126|FG000|Participant Flow|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
10909306|NCT00607126|FG001|Participant Flow|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
10909307|NCT00607126|OG000|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
10909308|NCT00607126|OG001|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
11174244|NCT02020577|BG001|Baseline|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
11174245|NCT02020577|BG002|Baseline|Total|Total of all reporting groups
10909309|NCT00607126|EG000|Reported Event|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
10909310|NCT00607126|EG001|Reported Event|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
10909311|NCT00607243|BG000|Baseline|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
10909312|NCT00607243|BG001|Baseline|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
10909313|NCT00607243|BG002|Baseline|Total|Total of all reporting groups
10909314|NCT00607243|FG000|Participant Flow|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
10909315|NCT00607243|FG001|Participant Flow|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
10909316|NCT00607243|OG000|Outcome|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
10909317|NCT00607243|OG001|Outcome|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
10909318|NCT00607243|EG000|Reported Event|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
10909319|NCT00607243|EG001|Reported Event|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
10909320|NCT00607269|BG000|Baseline|Control|Control condition receiving minimal incentives for service program attendance and participation.
10909321|NCT00607269|BG001|Baseline|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
10909322|NCT00607269|BG002|Baseline|Total|Total of all reporting groups
10909323|NCT00607269|FG000|Participant Flow|Control|Control condition receiving minimal incentives for service program attendance and participation.
10909324|NCT00607269|FG001|Participant Flow|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
10909325|NCT00607269|OG000|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
10909326|NCT00607269|OG001|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
10909327|NCT00607269|EG000|Reported Event|Control|Control condition receiving minimal incentives for service program attendance and participation.
10909328|NCT00607269|EG001|Reported Event|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
10909329|NCT00607321|BG000|Baseline|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
10909330|NCT00607321|FG000|Participant Flow|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
10909331|NCT00607321|OG000|Outcome|Subjects Receiving Bifurcation Stents|
10909332|NCT00607321|OG000|Outcome|Bifurcation Stent System|
10909333|NCT00607321|OG000|Outcome|Bifurcation Stent System|Evaluable patients within pre-specified follow up window
10909334|NCT00607321|EG000|Reported Event|1. Branch Bifurcation Stent System|All subjects enrolled in the BRANCH study
10909335|NCT00607373|BG000|Baseline|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
10909336|NCT00607373|BG001|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10909337|NCT00607373|BG002|Baseline|Total|Total of all reporting groups
10909338|NCT00607373|FG000|Participant Flow|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
10909339|NCT00607373|FG001|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10909340|NCT00607373|OG000|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
10909341|NCT00607373|OG001|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10909342|NCT00607373|EG000|Reported Event|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
10909343|NCT00607373|EG001|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10909344|NCT00607386|BG000|Baseline|Idursulfase|Open-label treatment with idursulfase
10909345|NCT00607386|FG000|Participant Flow|Idursulfase|Open-label treatment with idursulfase
10909346|NCT00607386|OG000|Outcome|Idursulfase|Open-label treatment with idursulfase
10909347|NCT00607386|EG000|Reported Event|Idursulfase|Open-label treatment with idursulfase
10909348|NCT00607594|BG000|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
10909349|NCT00607594|FG000|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
10909350|NCT00607594|OG000|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
10909351|NCT00607594|OG000|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.~saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
10909352|NCT00607594|OG000|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.~saracatinib~laboratory biomarker analysis: Correlative studies"
10909353|NCT00607594|EG000|Reported Event|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.~saracatinib~laboratory biomarker analysis: Correlative studies"
10909354|NCT00607620|BG000|Baseline|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
10909355|NCT00607620|BG001|Baseline|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
10909356|NCT00607620|BG002|Baseline|Total|Total of all reporting groups
10909357|NCT00607620|FG000|Participant Flow|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
10909358|NCT00607620|FG001|Participant Flow|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
10909359|NCT00607620|OG000|Outcome|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
10909360|NCT00607620|OG001|Outcome|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
10909361|NCT00607620|EG000|Reported Event|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
10909362|NCT00607620|EG001|Reported Event|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
10909363|NCT00607672|BG000|Baseline|Placebo|Patients are randomized to placebo prior to surgery
10909364|NCT00607672|BG001|Baseline|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
10909365|NCT00607672|BG002|Baseline|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
10909366|NCT00607672|BG003|Baseline|Total|Total of all reporting groups
10909367|NCT00607672|FG000|Participant Flow|Placebo|Patients are randomized to placebo prior to surgery
10909368|NCT00607672|FG001|Participant Flow|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
10909369|NCT00607672|FG002|Participant Flow|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
10909370|NCT00607672|OG000|Outcome|Placebo|Placebo group
10909371|NCT00607672|OG001|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
10909372|NCT00607672|OG002|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
11233573|NCT02429115|EG004|Reported Event|Online Peer Mentoring Caregivers|"Will receive 6 months of online peer mentoring by a trained peer mentor.~Mentoring: Six months of peer-mentoring."
10909373|NCT00607672|OG000|Outcome|Placebo|Patients are randomized to placebo prior to surgery
10909374|NCT00607672|OG001|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
10909375|NCT00607672|OG002|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
10909376|NCT00607672|EG000|Reported Event|Placebo|Placebo group
10909377|NCT00607672|EG001|Reported Event|Ramipril (ACEI)|Angiotensin-converting enzyme group
10909378|NCT00607672|EG002|Reported Event|Candesartan (ARB)|Angiotensin receptor blocker group
10909379|NCT00607724|BG000|Baseline|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
10909380|NCT00607724|BG001|Baseline|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
10909381|NCT00607724|BG002|Baseline|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
10909382|NCT00607724|BG003|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
11233574|NCT02429115|EG005|Reported Event|Control Caregivers|Will not receive peer mentoring.
11233575|NCT02429258|BG000|Baseline|Dapagliflozin|Dapagliflozin + Metformin or Insulin
10909383|NCT00607724|BG004|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909384|NCT00607724|BG005|Baseline|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909385|NCT00607724|BG006|Baseline|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability
10909386|NCT00607724|BG007|Baseline|Total|Total of all reporting groups
10909387|NCT00607724|FG000|Participant Flow|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 milligram (mg) on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0), maximum benefit, or intolerability.
10909388|NCT00607724|FG001|Participant Flow|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
10909389|NCT00607724|FG002|Participant Flow|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
10909390|NCT00607724|FG003|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909391|NCT00607724|FG004|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909392|NCT00607724|FG005|Participant Flow|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909393|NCT00607724|FG006|Participant Flow|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909394|NCT00607724|OG000|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
10909395|NCT00607724|OG001|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
10909396|NCT00607724|OG002|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
10909397|NCT00607724|OG003|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909398|NCT00607724|OG004|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909399|NCT00607724|OG005|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909400|NCT00607724|OG006|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909401|NCT00607724|OG003|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909402|NCT00607724|OG000|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
10909403|NCT00607724|OG001|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
10909404|NCT00607724|OG001|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
11233576|NCT02429258|BG001|Baseline|Placebo|Placebo + Metformin or Insulin
10909405|NCT00607724|OG000|Outcome|Stage 1: GDC-0449|Included participants with any tumor who received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg, 270 mg and 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, 270 mg and 540 mg orally, continuing until disease progression, maximum benefit, or intolerability.
10909406|NCT00607724|OG000|Outcome|All Participants|Included all participants from Stage 1 and Stage 2.
10909407|NCT00607724|OG006|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909408|NCT00607724|OG005|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909409|NCT00607724|EG000|Reported Event|Stage 1: GDC-0449 (150 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1, thereafter Day 8 received daily until disease progression, maximum benefit, or intolerability.
10909410|NCT00607724|EG001|Reported Event|Stage 1: GDC-0449 (270 mg)|Stage 1: GDC-0449 (270 mg) Participants received single dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
10909411|NCT00607724|EG002|Reported Event|Stage 1: GDC-0449 (540 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 540 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
10909412|NCT00607724|EG003|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
10909413|NCT00607724|EG004|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1 until disease progression, maximum benefit, or intolerability.
10909414|NCT00607724|EG005|Reported Event|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants with tolerable safety, pharmacokinetic and pharmacodynamic data from Stage 1 received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
10909415|NCT00607724|EG006|Reported Event|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
10909416|NCT00607789|BG000|Baseline|Duloxetine Group|Participants were randomized to 30-120 mg/day of duloxetine for 12 weeks
10909417|NCT00607789|BG001|Baseline|Placebo Group|Participants who were randomized to 30-120 mg/day of sugar pill for 12 weeks
10909418|NCT00607789|BG002|Baseline|Total|Total of all reporting groups
10909419|NCT00607789|FG000|Participant Flow|Duloxetine Group|30-120 mg/day of duloxetine during a 12-week period
10909420|NCT00607789|FG001|Participant Flow|Placebo Group|Placebo tablets (identical to duloxetine tablets), 30-120 mg/d given over 12-week period
10909421|NCT00607789|OG000|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
10909422|NCT00607789|OG001|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
10909423|NCT00607789|EG000|Reported Event|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks.
10909424|NCT00607789|EG001|Reported Event|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
10909425|NCT00607815|BG000|Baseline|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
10909426|NCT00607815|BG001|Baseline|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
10909427|NCT00607815|BG002|Baseline|Total|Total of all reporting groups
10909428|NCT00607815|FG000|Participant Flow|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
10909429|NCT00607815|FG001|Participant Flow|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
10909430|NCT00607815|OG000|Outcome|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
10909431|NCT00607815|OG001|Outcome|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
11233577|NCT02429258|BG002|Baseline|Total|Total of all reporting groups
11173119|NCT02013830|EG000|Reported Event|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
11173120|NCT02014051|BG000|Baseline|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
11173121|NCT02014051|FG000|Participant Flow|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
10909432|NCT00607815|OG000|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
10909433|NCT00607815|OG001|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
10909434|NCT00607815|EG000|Reported Event|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
10909435|NCT00607815|EG001|Reported Event|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
10909436|NCT00607867|BG000|Baseline|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat.
10909437|NCT00607867|BG001|Baseline|Control Diet|A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat
10909438|NCT00607867|BG002|Baseline|Total|Total of all reporting groups
10909439|NCT00607867|FG000|Participant Flow|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
10909440|NCT00607867|FG001|Participant Flow|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
10909441|NCT00607867|OG000|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
10909442|NCT00607867|OG001|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
10909443|NCT00607867|EG000|Reported Event|LoBAG30 Diet|"A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.~LoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat."
10909444|NCT00607867|EG001|Reported Event|Control Diet|"A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks.~Control Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat"
10909445|NCT00607880|BG000|Baseline|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
11173122|NCT02014051|FG001|Participant Flow|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
11173123|NCT02014051|OG000|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
11233578|NCT02429258|FG000|Participant Flow|Dapagliflozin|Dapagliflozin + Metformin or Insulin
11233579|NCT02429258|FG001|Participant Flow|Placebo|Placebo + Metformin or Insulin
10909446|NCT00607880|BG001|Baseline|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
10909447|NCT00607880|BG002|Baseline|Total|Total of all reporting groups
10909448|NCT00607880|FG000|Participant Flow|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
10909449|NCT00607880|FG001|Participant Flow|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
11233580|NCT02429258|OG000|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
10909450|NCT00607880|OG000|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
10909451|NCT00607880|OG001|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
10909452|NCT00607880|EG000|Reported Event|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
10909453|NCT00607880|EG001|Reported Event|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
10909454|NCT00607893|BG000|Baseline|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
10909455|NCT00607893|BG001|Baseline|Sham CPAP|Participants used the Sham CPAP every night for 8 weeks.
10909456|NCT00607893|BG002|Baseline|Total|Total of all reporting groups
10909457|NCT00607893|FG000|Participant Flow|Sham CPAP|"Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.~Sham treatment: Participants will use the lower pressure CPAP every night for 8 weeks."
10909458|NCT00607893|FG001|Participant Flow|Treatment CPAP|"Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.~Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks."
10909459|NCT00607893|OG000|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
10909460|NCT00607893|OG001|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
10909461|NCT00607893|EG000|Reported Event|SHAM CPAP|"Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.~Sham CPAP: Participants will use the lower pressure CPAP every night for 8 weeks."
11173124|NCT02014051|OG001|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
10909462|NCT00607893|EG001|Reported Event|Treatment CPAP|"Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.~Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks."
10909463|NCT00607893|EG002|Reported Event|Run-in/Washout Treatment CPAP|The initial run-in and washout period for study qualification to document CPAP adherence on treatment CPAP.
10909464|NCT00607893|EG003|Reported Event|Run-in/Washout Sham CPAP|The initial run-in and washout period for study qualification to document CPAP adherence on Sham CPAP (negligible pressure).
10909465|NCT00607919|BG000|Baseline|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
10909466|NCT00607919|BG001|Baseline|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
10909467|NCT00607919|BG002|Baseline|Total|Total of all reporting groups
10909468|NCT00607919|FG000|Participant Flow|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
10909469|NCT00607919|FG001|Participant Flow|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
10909470|NCT00607919|OG000|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
10909471|NCT00607919|OG001|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
11233581|NCT02429258|OG001|Outcome|Placebo|Placebo + Metformin or Insulin
11173125|NCT02014051|OG000|Outcome|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
10909472|NCT00607919|OG002|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
10909473|NCT00607919|OG001|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
10909474|NCT00607919|EG000|Reported Event|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine"
10909475|NCT00607919|EG001|Reported Event|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
10909476|NCT00607997|BG000|Baseline|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
10909477|NCT00607997|BG001|Baseline|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
10909478|NCT00607997|BG002|Baseline|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
10909479|NCT00607997|BG003|Baseline|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
10909480|NCT00607997|BG004|Baseline|Total|Total of all reporting groups
10909481|NCT00607997|FG000|Participant Flow|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
10909482|NCT00607997|FG001|Participant Flow|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
10909483|NCT00607997|FG002|Participant Flow|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
10909484|NCT00607997|FG003|Participant Flow|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
10909485|NCT00607997|OG000|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
10909486|NCT00607997|OG001|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
10909487|NCT00607997|OG002|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
10909488|NCT00607997|OG003|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
10909489|NCT00607997|OG004|Outcome|Total|Schedule A, B and C combined
10909490|NCT00607997|OG004|Outcome|Total|Schedule A, B, and C combined
10909491|NCT00607997|OG000|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
10909492|NCT00607997|OG001|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
10909493|NCT00607997|OG002|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
10909494|NCT00607997|EG000|Reported Event|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
10909495|NCT00607997|EG001|Reported Event|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
10909496|NCT00607997|EG002|Reported Event|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
10909497|NCT00607997|EG003|Reported Event|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
10909498|NCT00608062|BG000|Baseline|Pre1|"Premenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
11233582|NCT02429258|EG000|Reported Event|Dapagliflozin|Dapagliflozin + Metformin or Insulin
10909499|NCT00608062|BG001|Baseline|Pre2|"Premenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909500|NCT00608062|BG002|Baseline|Peri1|"Perimenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909501|NCT00608062|BG003|Baseline|Peri2|"Perimenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909502|NCT00608062|BG004|Baseline|Post1|"Postmenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909503|NCT00608062|BG005|Baseline|Post2|"Postmenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909504|NCT00608062|BG006|Baseline|Total|Total of all reporting groups
10909505|NCT00608062|FG000|Participant Flow|Pre1|"Premenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909506|NCT00608062|FG001|Participant Flow|Pre2|"Premenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909507|NCT00608062|FG002|Participant Flow|Peri1|"Perimenopausal (early and late combined) - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909508|NCT00608062|FG003|Participant Flow|Peri2|"Perimenopausal (early and late combined) - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909509|NCT00608062|FG004|Participant Flow|Post1|"Postmenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909510|NCT00608062|FG005|Participant Flow|Post2|"Postmenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909511|NCT00608062|OG000|Outcome|Pre1|"Premenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909512|NCT00608062|OG001|Outcome|Pre2|"Premenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909513|NCT00608062|OG002|Outcome|Peri1|"Perimenopausal (early and late combined) - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909514|NCT00608062|OG003|Outcome|Peri2|"Perimenopausal (early and late combined) - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909515|NCT00608062|OG004|Outcome|Post1|"Postmenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909516|NCT00608062|OG005|Outcome|Post2|"Postmenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
11233583|NCT02429258|EG001|Reported Event|Placebo|Placebo + Metformin or Insulin
10909517|NCT00608062|OG002|Outcome|Peri1|"Perimenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909518|NCT00608062|OG003|Outcome|Peri2|"Perimenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909519|NCT00608062|EG000|Reported Event|Pre1|"Premenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909520|NCT00608062|EG001|Reported Event|Pre2|"Premenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909521|NCT00608062|EG002|Reported Event|Peri1|"Perimenopausal (early and late combined) - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909522|NCT00608062|EG003|Reported Event|Peri2|"Perimenopausal (early and late combined) - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909523|NCT00608062|EG004|Reported Event|Post1|"Postmenopausal - GnRHant plus estradiol~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal estradiol patch: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909524|NCT00608062|EG005|Reported Event|Post2|"Postmenopausal - GnRHant plus placebo~GnRHant - Ganirelix acetate: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7~Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)"
10909525|NCT00608140|BG000|Baseline|1 Medical Therapy Plus Surgical Repair|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
10909526|NCT00608140|BG001|Baseline|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
10909527|NCT00608140|BG002|Baseline|Total|Total of all reporting groups
10909528|NCT00608140|FG000|Participant Flow|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
10909529|NCT00608140|FG001|Participant Flow|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
10909530|NCT00608140|OG000|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
10909531|NCT00608140|OG001|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
10909532|NCT00608140|OG000|Outcome|Optimal Medical Therapy Plus Surgical MV Repair|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering."
10909533|NCT00608140|OG001|Outcome|Optimal Medical Therapy Alone|"Participants will receive optimal medical therapy alone~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
10909534|NCT00608140|OG002|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering."
10909535|NCT00608140|OG000|Outcome|Optimal Medical Therapy Plus Surgical MVR|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or signific"
11233584|NCT02429310|BG000|Baseline|Supervised Exercise Only|This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.
10909536|NCT00608140|OG002|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for rup"
10909537|NCT00608140|OG000|Outcome|Optimal Medical Therapy Plus Surgical MVR|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
10909538|NCT00608140|OG002|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
10909539|NCT00608140|OG000|Outcome|Optimal Medical Therapy Plus Surgical MVR|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
10909540|NCT00608140|OG002|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
10909541|NCT00608140|EG000|Reported Event|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
10909542|NCT00608140|EG001|Reported Event|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
10909543|NCT00608205|BG000|Baseline|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
10909544|NCT00608205|BG001|Baseline|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
11173126|NCT02014051|EG000|Reported Event|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
10909545|NCT00608205|BG002|Baseline|Total|Total of all reporting groups
10909546|NCT00608205|FG000|Participant Flow|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
10909547|NCT00608205|FG001|Participant Flow|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
10909548|NCT00608205|OG000|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
10909549|NCT00608205|OG001|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
10909550|NCT00608205|OG000|Outcome|Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
11173127|NCT02014051|EG001|Reported Event|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
11173128|NCT02014116|BG000|Baseline|Cohort 1|"50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
10909551|NCT00608205|OG001|Outcome|Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
10909552|NCT00608205|EG000|Reported Event|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
10909553|NCT00608205|EG001|Reported Event|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
10909554|NCT00608244|BG000|Baseline|LCP-Tacro|Evaluation of steady state tacrolimus exposure (AUC0-24) and trough levels (C24) in stable liver transplant recipients converted from Prograf to LCP-Tacro in a 3-sequence study design and validate the dose conversion ratio determined in the Phase 1 program.
10909555|NCT00608244|FG000|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.~On Day 22, patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.~LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL."
10909556|NCT00608244|OG000|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
10909557|NCT00608244|OG000|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
10909558|NCT00608244|EG000|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.~59 patients were enrolled into the study and all 59 were dosed with LCP-Tacro."
10909559|NCT00608244|EG001|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.~59 patients were enrolled into the study and all 59 were dosed with Prograf. Adverse Events occurring during the follow up period (Days 22-51) have been counted in the Prograf treatment arm as patients were on Prograf during this period."
10909560|NCT00608322|BG000|Baseline|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
10909561|NCT00608322|BG001|Baseline|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
10909562|NCT00608322|BG002|Baseline|Total|Total of all reporting groups
10909563|NCT00608322|FG000|Participant Flow|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
10909564|NCT00608322|FG001|Participant Flow|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
10909565|NCT00608322|OG000|Outcome|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
10909566|NCT00608322|OG001|Outcome|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
10909567|NCT00608322|EG000|Reported Event|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
10909568|NCT00608322|EG001|Reported Event|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
10909569|NCT00608426|BG000|Baseline|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
10909570|NCT00608426|BG001|Baseline|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
11173129|NCT02014116|BG001|Baseline|Cohort 2|"100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
10909571|NCT00608426|BG002|Baseline|Total|Total of all reporting groups
10909572|NCT00608426|FG000|Participant Flow|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
10909573|NCT00608426|FG001|Participant Flow|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
10909574|NCT00608426|OG000|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
10909575|NCT00608426|OG001|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
10909576|NCT00608426|EG000|Reported Event|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
10909577|NCT00608426|EG001|Reported Event|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
10909578|NCT00608491|BG000|Baseline|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
10909579|NCT00608491|BG001|Baseline|Ultrafiltration|Participants will receive ultrafiltration
10909580|NCT00608491|BG002|Baseline|Total|Total of all reporting groups
11173130|NCT02014116|BG002|Baseline|Cohort 3|"200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
11173131|NCT02014116|BG003|Baseline|Cohort 4|"400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
10909581|NCT00608491|FG000|Participant Flow|Stepped Pharmacologic Care|Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes
10909582|NCT00608491|FG001|Participant Flow|Ultrafiltration|Participants will receive ultrafiltration
11091185|NCT01533493|BG000|Baseline|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
11091186|NCT01533493|BG001|Baseline|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
11091187|NCT01533493|BG002|Baseline|Total|Total of all reporting groups
11091188|NCT01533493|FG000|Participant Flow|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
11173132|NCT02014116|BG004|Baseline|Cohort 5|"500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
11173133|NCT02014116|BG005|Baseline|Cohort 6|"300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
10909583|NCT00608491|OG000|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
10909584|NCT00608491|OG001|Outcome|Ultrafiltration|Participants will receive ultrafiltration
10909585|NCT00608491|EG000|Reported Event|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
10909586|NCT00608491|EG001|Reported Event|Ultrafiltration|Participants will receive ultrafiltration
10909587|NCT00608517|BG000|Baseline|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
10909588|NCT00608517|BG001|Baseline|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
10909589|NCT00608517|BG002|Baseline|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
10909590|NCT00608517|BG003|Baseline|Total|Total of all reporting groups
10909591|NCT00608517|FG000|Participant Flow|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
10909592|NCT00608517|FG001|Participant Flow|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
10909593|NCT00608517|FG002|Participant Flow|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
10909594|NCT00608517|OG000|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
10909595|NCT00608517|OG001|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
10909596|NCT00608517|OG002|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
10909597|NCT00608517|OG000|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours
10909598|NCT00608517|EG000|Reported Event|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
10909599|NCT00608517|EG001|Reported Event|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
10909600|NCT00608517|EG002|Reported Event|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
10909601|NCT00608530|BG000|Baseline|Cognitive Behavioral Therapy-Psychologist-Delivered|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact by a psychologist~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily)."
10909602|NCT00608530|BG001|Baseline|Supportive Psychotherapy-Psychologist-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact by a psychologist~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
10909603|NCT00608530|BG002|Baseline|Cognitive Behavioral Therapy-Nurse-Delivered|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact by a medical nurse~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily)."
10909604|NCT00608530|BG003|Baseline|Supportive Psychotherapy-Nurse-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact by a medical nurse~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
10909605|NCT00608530|BG004|Baseline|Total|Total of all reporting groups
10909606|NCT00608530|FG000|Participant Flow|Cognitive Behavioral Therapy-Psychologist-Dellivered|"10 hours of Cognitive Behavioral Training delivered by a psychologist over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
10909607|NCT00608530|FG001|Participant Flow|Supportive Psychotherapy-Psychologist-Delivered|"10 hours of Rogerian Supportive Psychotherapy delivered by a psychologist over 8 weeks by telephone and face-to-face contact~Rogerian supportive psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach"
10909608|NCT00608530|FG002|Participant Flow|Cognitive Behavioral Therapy-Nurse-Delivered|"10 hours of Cognitive Behavioral Training delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
10909609|NCT00608530|FG003|Participant Flow|Supportive Psychotherapy-Nurse-Delivered|10 hours of Supportive Psychotherapy delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
10909610|NCT00608530|OG000|Outcome|Cognitive Behavioral Therapy Psychol-Delivered Treatment Study|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily)."
10909611|NCT00608530|OG001|Outcome|Supportive Psychotherapy-Psychologist-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
10909612|NCT00608530|OG000|Outcome|Cognitive Behavioral Therapy Nurse-Delivered Treatment Study|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily)."
10909613|NCT00608530|OG001|Outcome|Supportive Psychotherapy Nurse-Delivered Treatment Study|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
10909614|NCT00608530|OG000|Outcome|Cognitive Behavioral Therapy-Psychologist Delivered|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks by a psychologist
10909615|NCT00608530|OG001|Outcome|Supportive Care Psychologist-Delivered|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks by a psychologist
10909616|NCT00608530|OG000|Outcome|Cognitive Behavioral Therapy Nurse-Delivered Treatment Study|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
10909617|NCT00608530|OG001|Outcome|Supportive Psychotherapy Nurse-Delivered Treatment Study|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
10909618|NCT00608530|OG001|Outcome|Supportive Care-Psychologist-Delivered|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks by a psychologist
10909619|NCT00608530|EG000|Reported Event|Cognitive Behavioral Therapy-Psychologist-Delivered|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
10909620|NCT00608530|EG001|Reported Event|Supportive Psychotherapy-Psychologist-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapists encourage individuals to identify goals and solutions using a supportive, reflective, empathic approach rather than a directive or prescriptive approach"
10909621|NCT00608530|EG002|Reported Event|Cognitive Behavioral Therapy-Nurse-Delivered|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
10909622|NCT00608530|EG003|Reported Event|Supportive Psychotherapy Nurse-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapists encourage individuals to identify goals and solutions using a supportive, reflective, empathic approach rather than a directive or prescriptive approach"
10909623|NCT00608543|BG000|Baseline|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
10909624|NCT00608543|FG000|Participant Flow|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
10909625|NCT00608543|OG000|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
10909626|NCT00608543|OG000|Outcome|Spatial Working Memory Between Errors for 6-move Problems|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
10909627|NCT00608543|EG000|Reported Event|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
10909628|NCT00608569|BG000|Baseline|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
10909629|NCT00608569|BG001|Baseline|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
10909630|NCT00608569|BG002|Baseline|Total|Total of all reporting groups
10909631|NCT00608569|FG000|Participant Flow|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
10909632|NCT00608569|FG001|Participant Flow|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
10909633|NCT00608569|OG000|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
10909634|NCT00608569|OG001|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
10909635|NCT00608569|EG000|Reported Event|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
10909636|NCT00608569|EG001|Reported Event|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
10909637|NCT00608582|BG000|Baseline|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
10909638|NCT00608582|BG001|Baseline|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
10909639|NCT00608582|BG002|Baseline|Total|Total of all reporting groups
10909640|NCT00608582|FG000|Participant Flow|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
10909641|NCT00608582|FG001|Participant Flow|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.~The patients then receive a series of 10 Real rTMS treatments.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
10909642|NCT00608582|OG000|Outcome|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
10909643|NCT00608582|OG001|Outcome|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
10909644|NCT00608582|OG000|Outcome|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
11173134|NCT02014116|BG006|Baseline|Cohort A|"300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Confirmation Phase"
11173135|NCT02014116|BG007|Baseline|Cohort B|"300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Confirmation Phase"
11173136|NCT02014116|BG008|Baseline|Cohort C|"300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Confirmation Phase"
10909645|NCT00608582|OG001|Outcome|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.~The patients then receive a series of 10 Real rTMS treatments.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
10909646|NCT00608582|EG000|Reported Event|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
10909647|NCT00608582|EG001|Reported Event|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
10909648|NCT00608634|BG000|Baseline|Arm I|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909649|NCT00608634|BG001|Baseline|Arm II|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909650|NCT00608634|BG002|Baseline|Arm III|Patients apply POH cream (0.76%) as in arm II.
10909651|NCT00608634|BG003|Baseline|Total|Total of all reporting groups
10909652|NCT00608634|FG000|Participant Flow|Placbeo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909653|NCT00608634|FG001|Participant Flow|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909654|NCT00608634|FG002|Participant Flow|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
10909655|NCT00608634|OG000|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909656|NCT00608634|OG001|Outcome|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909657|NCT00608634|OG002|Outcome|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
10909658|NCT00608634|OG001|Outcome|Low Dose 0.30% POH|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909659|NCT00608634|OG002|Outcome|High Dose 0.76% POH|Patients apply POH cream (0.76%) as in arm II.
10909660|NCT00608634|EG000|Reported Event|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909661|NCT00608634|EG001|Reported Event|Low Dose POH 0.3%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909662|NCT00608634|EG002|Reported Event|High Dose POH 0.76%|Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
10909663|NCT00608829|BG000|Baseline|45mm TAG Device Subjects|"The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true line extension, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter."
10909664|NCT00608829|FG000|Participant Flow|45mm TAG Device Subjects|"The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true line extension, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter."
10909665|NCT00608829|OG000|Outcome|45mm TAG Device Subjects|"The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true line extension, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter."
10909666|NCT00608829|EG000|Reported Event|45mm TAG Device Subjects|"The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true line extension, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter."
10909667|NCT00608842|BG000|Baseline|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909668|NCT00608842|BG001|Baseline|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909669|NCT00608842|BG002|Baseline|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909670|NCT00608842|BG003|Baseline|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909671|NCT00608842|BG004|Baseline|Total|Total of all reporting groups
10909672|NCT00608842|FG000|Participant Flow|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
11173137|NCT02014116|BG009|Baseline|Total|Total of all reporting groups
10909673|NCT00608842|FG001|Participant Flow|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909674|NCT00608842|FG002|Participant Flow|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909675|NCT00608842|FG003|Participant Flow|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909676|NCT00608842|OG000|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909677|NCT00608842|OG001|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909678|NCT00608842|OG002|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909679|NCT00608842|OG003|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909680|NCT00608842|EG000|Reported Event|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909681|NCT00608842|EG001|Reported Event|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909682|NCT00608842|EG002|Reported Event|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909683|NCT00608842|EG003|Reported Event|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
10909684|NCT00608868|BG000|Baseline|Gefitinib|gefitinib tablet 250 mg orally
10909685|NCT00608868|FG000|Participant Flow|Gefitinib|gefitinib tablet 250 mg orally
10909686|NCT00608868|OG000|Outcome|Gefitinib|gefitinib tablet 250 mg orally
10909687|NCT00608868|EG000|Reported Event|Gefitinib|gefitinib tablet 250 mg orally
10909688|NCT00608881|BG000|Baseline|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
10909689|NCT00608881|BG001|Baseline|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
10909690|NCT00608881|BG002|Baseline|Total|Total of all reporting groups
10909691|NCT00608881|FG000|Participant Flow|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
10909692|NCT00608881|FG001|Participant Flow|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
10909693|NCT00608881|OG000|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
10909694|NCT00608881|OG001|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
10909695|NCT00608881|EG000|Reported Event|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
10909696|NCT00608881|EG001|Reported Event|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
10909697|NCT00608894|BG000|Baseline|LCP-Tacro|"LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg)~LCP-Tacro (tacrolimus): LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6."
10909698|NCT00608894|BG001|Baseline|Azathioprine|"Azathioprine tablets(50mg)+ prednisone tablets(5mg)~Azathioprine: Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6."
10909699|NCT00608894|BG002|Baseline|Total|Total of all reporting groups
10909700|NCT00608894|FG000|Participant Flow|LCP-Tacro|"LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg)~LCP-Tacro (tacrolimus): LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6."
10909701|NCT00608894|FG001|Participant Flow|Azathioprine|"Azathioprine tablets(50mg)+ prednisone tablets(5mg)~Azathioprine: Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6."
10909702|NCT00608894|OG000|Outcome|LCP-Tacro|"LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg)~LCP-Tacro (tacrolimus): LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6."
10909703|NCT00608894|OG001|Outcome|Azathioprine|"Azathioprine tablets(50mg)+ prednisone tablets(5mg)~Azathioprine: Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6."
11173138|NCT02014116|FG000|Participant Flow|Cohort 1|"50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
11173139|NCT02014116|FG001|Participant Flow|Cohort 2|"100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
10909704|NCT00608894|OG000|Outcome|LCP-Tacro|"LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg)~LCP-Tacro (tacrolimus): LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.~Seven patients were randomized to LCP-Tacro. All 7 (100%) completed the study and no crossovers or early withdrawals occurred."
10909705|NCT00608894|OG001|Outcome|Azathioprine|"Azathioprine tablets(50mg)+ prednisone tablets(5mg)~Azathioprine: Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.~Six patients were randomized to Azathioprine. One patient (16.7%) was granted permission to crossover to LCP-Tacro due to treatment intolerance. Two patients (33.3%) withdrew early, and 4 patients (66.7%) completed the study."
10909706|NCT00608894|EG000|Reported Event|LCP-Tacro|"LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg)~LCP-Tacro (tacrolimus): LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6."
11173140|NCT02014116|FG002|Participant Flow|Cohort 3|"200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
11173141|NCT02014116|FG003|Participant Flow|Cohort 4|"400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
11173142|NCT02014116|FG004|Participant Flow|Cohort 5|"500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
11173143|NCT02014116|FG005|Participant Flow|Cohort 6|"300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Escalation Phase"
11173144|NCT02014116|FG006|Participant Flow|Cohort A|"300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Confirmation Phase"
11173145|NCT02014116|FG007|Participant Flow|Cohort B|"300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose Confirmation Phase"
11173146|NCT02014116|FG008|Participant Flow|Cohort C|"300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.~Dose confirmation Phase"
11173147|NCT02014116|OG000|Outcome|Part A LY3009120|"Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle.~Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle.~Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle.~Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle.~Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle.~Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle."
11173148|NCT02014116|OG000|Outcome|Cohort A|300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle
11173149|NCT02014116|OG001|Outcome|Cohort B|300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173150|NCT02014116|OG002|Outcome|Cohort C|300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173151|NCT02014116|OG000|Outcome|50 mg LY3009120|50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173152|NCT02014116|OG001|Outcome|100 mg LY3009120|100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173153|NCT02014116|OG002|Outcome|200 mg LY3009120|200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173154|NCT02014116|OG003|Outcome|300 mg LY3009120|300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173155|NCT02014116|OG004|Outcome|400 mg LY3009120|400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173156|NCT02014116|OG005|Outcome|500 mg LY3009120|500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173157|NCT02014116|OG005|Outcome|500 mg LY3009120|500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle
11173158|NCT02014116|OG005|Outcome|500 mg LY3009120|500 mg LY3009210 administered orally every 12 hours daily in a 28-day cycle.
11173159|NCT02014116|EG000|Reported Event|Cohort 1|50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173160|NCT02014116|EG001|Reported Event|Cohort 2|100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173161|NCT02014116|EG002|Reported Event|Cohort 3|200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173162|NCT02014116|EG003|Reported Event|Cohort 4|400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173163|NCT02014116|EG004|Reported Event|Cohort 5|500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173164|NCT02014116|EG005|Reported Event|Cohort 6|300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173165|NCT02014116|EG006|Reported Event|Cohort A|300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173166|NCT02014116|EG007|Reported Event|Cohort B|300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173167|NCT02014116|EG008|Reported Event|Cohort C|300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
11173168|NCT02014129|BG000|Baseline|Cohort 1 - 100 mg Abemaciclib|100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
11173169|NCT02014129|BG001|Baseline|Cohort 2 - 150 mg Abemaciclib|150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
11173170|NCT02014129|BG002|Baseline|Cohort 3 - 200 mg Abemaciclib|200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
11173171|NCT02014129|BG003|Baseline|Total|Total of all reporting groups
11173172|NCT02014129|FG000|Participant Flow|Cohort 1 - 100 mg Abemaciclib|100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
11173173|NCT02014129|FG001|Participant Flow|Cohort 2 - 150 mg Abemaciclib|150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
10909707|NCT00608894|EG001|Reported Event|Azathioprine|"Azathioprine tablets(50mg)+ prednisone tablets(5mg)~Azathioprine: Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6."
10909708|NCT00608907|BG000|Baseline|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
10909709|NCT00608907|BG001|Baseline|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
10909710|NCT00608907|BG002|Baseline|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
10909711|NCT00608907|BG003|Baseline|Total|Total of all reporting groups
10909712|NCT00608907|FG000|Participant Flow|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
10909713|NCT00608907|FG001|Participant Flow|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
10909714|NCT00608907|FG002|Participant Flow|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
10909715|NCT00608907|OG000|Outcome|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
10909716|NCT00608907|OG001|Outcome|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
10909717|NCT00608907|OG002|Outcome|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
10909718|NCT00608907|EG000|Reported Event|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
10909719|NCT00608907|EG001|Reported Event|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
10909720|NCT00608907|EG002|Reported Event|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
10909721|NCT00608959|BG000|Baseline|Omiganan 1% Gel (Part 2)|25 subjects were treated with omiganan 1% gel at skin and intravenous (IV) sites in Part 2.
10909722|NCT00608959|BG001|Baseline|Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1)|25 subjects were treated with chlorhexidine 2% and omiganan 1% in Part 1.
10909723|NCT00608959|BG002|Baseline|Total|Total of all reporting groups
10909724|NCT00608959|FG000|Participant Flow|Omiganan 1% Gel and Chlorhexidine|"In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen and chlorhexidine applied to 6 matching sites on the contralateral side.Swab cultures were taken at specified timepoints over 72 hours.~In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Swab cultures were taken at specified timepoints over 7 days.In addition subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period."
10909725|NCT00608959|OG000|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 3 days.
10909726|NCT00608959|OG001|Outcome|Chlorhexidine 2%(Part 1)|Chlorhexidine 2% solution was applied to 6 sites on the chest and/or abdomen. Swab cultures were obtained at specific timepoints over 3 days.
10909727|NCT00608959|OG000|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 7 days.
10909728|NCT00608959|OG000|Outcome|Omiganan 1% Gel (Part 2)|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
10909729|NCT00608959|OG001|Outcome|Chlorhexidine 2%/ Isopropyl Alcohol|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with chlorhexidine/isopropyl alcohol prior to catheter insertion.Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
10909730|NCT00608959|EG000|Reported Event|Omiganan 1% Gel (Part 1)|In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen.
10909731|NCT00608959|EG001|Reported Event|Chlorhexidine|In Part 1 each subject had chlorhexidine 2% applied to 6 sites located across the chest and/or abdomen. In Part 2 subjects had chlorhexidine 2%/isopropyl alcohol applied to one intravenous (IV) catheter site.
10909732|NCT00608959|EG002|Reported Event|Omiganan 1% (Part 2)|In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Omiganan 1% gel was applied to one intravenous (IV) catheter site.
10909733|NCT00608985|BG000|Baseline|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
10909734|NCT00608985|BG001|Baseline|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
10909735|NCT00608985|BG002|Baseline|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
10909736|NCT00608985|BG003|Baseline|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
10909737|NCT00608985|BG004|Baseline|Total|Total of all reporting groups
10909738|NCT00608985|FG000|Participant Flow|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
10909739|NCT00608985|FG001|Participant Flow|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
10909740|NCT00608985|FG002|Participant Flow|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
10909741|NCT00608985|FG003|Participant Flow|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
10909742|NCT00608985|OG000|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
10909743|NCT00608985|OG001|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
10909744|NCT00608985|OG002|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
10909745|NCT00608985|OG003|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
10909746|NCT00608985|EG000|Reported Event|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
10909747|NCT00608985|EG001|Reported Event|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
10909748|NCT00608985|EG002|Reported Event|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
10909749|NCT00608985|EG003|Reported Event|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
10909750|NCT00609128|BG000|Baseline|Olopatadine Treatment (Only One Eye)|one drop olopatadine in one eye only, two times per day at an interval of 6 to 8 hours for 1 week. This allows the untreated eye to be the control.
10909751|NCT00609128|FG000|Participant Flow|Olopatadine|one drop olopatadine in one eye only, two times per day at an interval of 6 to 8 hours for 1 week. This allows the untreated eye to be the control.
10909752|NCT00609128|OG000|Outcome|Tears From Olopatadine Treated Eyes|Allergic subjects treated one eye with olopatadine and did not treat other eye (control). Tears collected from both eyes and incubated with conjunctival epithelial cells. We determined whether tears collected from olopatadine treated eyes of subjects result in more or less purified peripheral blood eosinophil adhesion to conjunctival epithelial cells compared to tears collected from untreated eyes from the same subjects.
10909753|NCT00609128|OG001|Outcome|Tears From Untreated Eyes|Allergic subjects treated one eye with olopatadine and did not treat other eye (control). Tears collected from both eyes and incubated with conjunctival epithelial cells. We determined whether tears collected from olopatadine treated eyes of subjects result in more or less purified peripheral blood eosinophil adhesion to conjunctival epithelial cells compared to tears collected from untreated eyes from the same subjects.
10909754|NCT00609128|EG000|Reported Event|Olopatadine|
10909755|NCT00609167|BG000|Baseline|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
10909756|NCT00609167|BG001|Baseline|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
10909757|NCT00609167|BG002|Baseline|Total|Total of all reporting groups
10909758|NCT00609167|FG000|Participant Flow|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
10909759|NCT00609167|FG001|Participant Flow|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
10909760|NCT00609167|OG000|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
10909761|NCT00609167|OG001|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
10909762|NCT00609167|EG000|Reported Event|CyBorD (Bortezomib 1.3mg/m^2)|Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
10909763|NCT00609167|EG001|Reported Event|CyBorD (Bortezomib 1.5mg/m^2)|Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22
10909764|NCT00609245|BG000|Baseline|Valproate Infusion|"placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.~Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003)."
10909765|NCT00609245|FG000|Participant Flow|Valproate Infusion|"placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.~Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003)."
10909766|NCT00609245|OG000|Outcome|Placebo|Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration.
10909767|NCT00609245|OG001|Outcome|Valproic Acid|The investigators will utilize intravenous sodium valproate. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
10909768|NCT00609245|EG000|Reported Event|Valproic Acid|Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
10909769|NCT00609245|EG001|Reported Event|Placebo|placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
10909770|NCT00609271|BG000|Baseline|Low Carbohydrate Diet|low carbohydrate diet: <40 grams carbohydrate/day
10909771|NCT00609271|BG001|Baseline|Low Fat Diet|low fat diet: <30% fat, <7% saturated fat
10909772|NCT00609271|BG002|Baseline|Total|Total of all reporting groups
10909773|NCT00609271|FG000|Participant Flow|Low Carbohydrate Diet|low carbohydrate diet: <40 grams carbohydrate/day
10909774|NCT00609271|FG001|Participant Flow|Low Fat Diet|low fat diet: <30% fat, <7% saturated fat
10909775|NCT00609271|OG000|Outcome|Low Carbohydrate Diet|low carbohydrate diet: <40 grams carbohydrate/day
10909776|NCT00609271|OG001|Outcome|Low Fat Diet|low fat diet: <30% fat, <7% saturated fat
11091189|NCT01533493|FG001|Participant Flow|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
11091190|NCT01533493|OG000|Outcome|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
11091191|NCT01533493|OG001|Outcome|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
11091192|NCT01533493|EG000|Reported Event|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
11091193|NCT01533493|EG001|Reported Event|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
10909777|NCT00609271|EG000|Reported Event|Low Carbohydrate Diet|low carbohydrate diet: <40 grams carbohydrate/day
10909778|NCT00609271|EG001|Reported Event|Low Fat Diet|low fat diet: <30% fat, <7% saturated fat
10909779|NCT00609336|BG000|Baseline|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
10909780|NCT00609336|FG000|Participant Flow|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~gemcitabine: Given IV~oxaliplatin: Given IV"
10909781|NCT00609336|OG000|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
10909782|NCT00609336|OG000|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~gemcitabine: Given IV~oxaliplatin: Given IV"
11091194|NCT01533597|BG000|Baseline|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
11091195|NCT01533597|BG001|Baseline|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
10909783|NCT00609336|EG000|Reported Event|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~gemcitabine: Given IV~oxaliplatin: Given IV"
10909784|NCT00609362|BG000|Baseline|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
10909785|NCT00609362|BG001|Baseline|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
10909786|NCT00609362|BG002|Baseline|Total|Total of all reporting groups
10909787|NCT00609362|FG000|Participant Flow|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
10909788|NCT00609362|FG001|Participant Flow|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
10909789|NCT00609362|OG000|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
10909790|NCT00609362|OG001|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
10909791|NCT00609362|EG000|Reported Event|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
10909792|NCT00609362|EG001|Reported Event|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
10909793|NCT00609466|BG000|Baseline|CG5503|CG5503 IR 75mg 4-6 hourly
10909794|NCT00609466|BG001|Baseline|Morphine|Morphine IR 30mg 4 to 6 hourly
10909795|NCT00609466|BG002|Baseline|Placebo|Matching Placebo 4 to 6 hourly
10909796|NCT00609466|BG003|Baseline|Total|Total of all reporting groups
10909797|NCT00609466|FG000|Participant Flow|CG5503|CG5503 IR 75mg 4-6 hourly
10909798|NCT00609466|FG001|Participant Flow|Morphine|Morphine IR 30mg 4 to 6 hourly
10909799|NCT00609466|FG002|Participant Flow|Placebo|Matching Placebo 4 to 6 hourly
10909800|NCT00609466|OG000|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
10909801|NCT00609466|OG001|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
10909802|NCT00609466|OG002|Outcome|Placebo|Matching Placebo 4 to 6 hourly
10909803|NCT00609466|EG000|Reported Event|CG5503|CG5503 IR 75mg 4-6 hourly
11233585|NCT02429310|BG001|Baseline|NMES + Supervised Exercise|"This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed.~Revitive IX: This is a neuromuscular electrical stimulation device"
10909804|NCT00609466|EG001|Reported Event|Morphine|Morphine IR 30mg 4 to 6 hourly
10909805|NCT00609466|EG002|Reported Event|Placebo|Matching Placebo 4 to 6 hourly
10909806|NCT00609492|BG000|Baseline|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909807|NCT00609492|BG001|Baseline|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
11233586|NCT02429310|BG002|Baseline|Total|Total of all reporting groups
10909808|NCT00609492|BG002|Baseline|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909809|NCT00609492|BG003|Baseline|Total|Total of all reporting groups
10909810|NCT00609492|FG000|Participant Flow|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909811|NCT00609492|FG001|Participant Flow|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909812|NCT00609492|FG002|Participant Flow|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909813|NCT00609492|OG000|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909814|NCT00609492|OG001|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909815|NCT00609492|OG000|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
11091196|NCT01533597|BG002|Baseline|Total|Total of all reporting groups
10909816|NCT00609492|OG001|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909817|NCT00609492|OG002|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909818|NCT00609492|OG001|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid
10909819|NCT00609492|EG000|Reported Event|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909820|NCT00609492|EG001|Reported Event|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
10909821|NCT00609518|BG000|Baseline|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
10909822|NCT00609518|BG001|Baseline|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
10909823|NCT00609518|BG002|Baseline|Total|Total of all reporting groups
10909824|NCT00609518|FG000|Participant Flow|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
10909825|NCT00609518|FG001|Participant Flow|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
10909826|NCT00609518|OG000|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
10909827|NCT00609518|OG001|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
10909828|NCT00609518|EG000|Reported Event|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
10909829|NCT00609518|EG001|Reported Event|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
10909830|NCT00609609|BG000|Baseline|Corticosteroids|Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
10909831|NCT00609609|BG001|Baseline|ECP + Corticosteroids|Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
10909832|NCT00609609|BG002|Baseline|Total|Total of all reporting groups
10909833|NCT00609609|FG000|Participant Flow|Corticosteroids|Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
10909834|NCT00609609|FG001|Participant Flow|ECP + Corticosteroids|Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
10909835|NCT00609609|OG000|Outcome|Corticosteroids|Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
10909836|NCT00609609|OG001|Outcome|ECP + Corticosteroids|Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
10909837|NCT00609609|EG000|Reported Event|Corticosteroids|Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
10909838|NCT00609609|EG001|Reported Event|ECP + Corticosteroids|Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
11091197|NCT01533597|FG000|Participant Flow|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
11091198|NCT01533597|FG001|Participant Flow|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
11091199|NCT01533597|OG000|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
10909839|NCT00609622|BG000|Baseline|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
10909840|NCT00609622|BG001|Baseline|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
10909841|NCT00609622|BG002|Baseline|Total|Total of all reporting groups
10909842|NCT00609622|FG000|Participant Flow|Sunitinib + mFOLFOX6|Sunitinib 37.5 milligram (mg) capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, lecovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg per square meter (mg/m^2) and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour intravenous (IV) infusion followed by an IV bolus of 5-fluorouracil (5-FU) 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
10909843|NCT00609622|FG001|Participant Flow|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kilogram (mg/kg) administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and a 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
10909844|NCT00609622|OG000|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
10909845|NCT00609622|OG001|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
10909846|NCT00609622|EG000|Reported Event|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
10909847|NCT00609622|EG001|Reported Event|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
10909848|NCT00609674|BG000|Baseline|Placebo|Placebo nasal spray
10909849|NCT00609674|BG001|Baseline|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
10909850|NCT00609674|BG002|Baseline|Total|Total of all reporting groups
10909851|NCT00609674|FG000|Participant Flow|Placebo|Placebo nasal spray
10909852|NCT00609674|FG001|Participant Flow|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
10909853|NCT00609674|OG000|Outcome|Placebo|Placebo nasal spray
10909854|NCT00609674|OG001|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
10909855|NCT00609674|EG000|Reported Event|Placebo|Placebo nasal spray
10909856|NCT00609674|EG001|Reported Event|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
10909857|NCT00609739|BG000|Baseline|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
10909858|NCT00609739|FG000|Participant Flow|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
10909859|NCT00609739|OG000|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
10909860|NCT00609739|EG000|Reported Event|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
10909861|NCT00609804|BG000|Baseline|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909862|NCT00609804|BG001|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909863|NCT00609804|BG002|Baseline|Total|Total of all reporting groups
10909864|NCT00609804|FG000|Participant Flow|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909865|NCT00609804|FG001|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909866|NCT00609804|OG000|Outcome|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909867|NCT00609804|OG001|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909868|NCT00609804|OG000|Outcome|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909869|NCT00609804|OG001|Outcome|Sorafenib|Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909870|NCT00609804|OG000|Outcome|Sorafenib and Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909871|NCT00609804|EG000|Reported Event|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909872|NCT00609804|EG001|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
10909873|NCT00609869|BG000|Baseline|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
10909874|NCT00609869|FG000|Participant Flow|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
10909875|NCT00609869|OG000|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
10909876|NCT00609869|EG000|Reported Event|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
10909877|NCT00609947|BG000|Baseline|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
10909878|NCT00609947|FG000|Participant Flow|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eltuing stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
10909879|NCT00609947|OG000|Outcome|Primary Effectiveness Analysis Endpoint - SVS|The 8-month in-segment diameter stenosis from Endeavor Small Vessel Study (SVS) subects
10909880|NCT00609947|OG000|Outcome|Primary Analysis Endpoint|
10909881|NCT00609947|EG000|Reported Event|Primary Analysis Endpoint|"The first 97 subjects enrolled and implanted with 2.25mm stents~The first 39 subjects enrolled and implanted with 2.5mm stents~The first 40 subjects enrolled and implanted with 2.75mm stents~A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"
10909882|NCT00609973|BG000|Baseline|Cipro|Ciprofloxacin 500 mg bid
10909883|NCT00609973|BG001|Baseline|Placebo|Placebo bid
10909884|NCT00609973|BG002|Baseline|Total|Total of all reporting groups
10909885|NCT00609973|FG000|Participant Flow|Cipro|Ciprofloxacin 500 mg bid
10909886|NCT00609973|FG001|Participant Flow|Placebo|Placebo bid
10909887|NCT00609973|OG000|Outcome|Cipro|Ciprofloxacin 500 mg bid
10909888|NCT00609973|OG001|Outcome|Placebo|Placebo bid
10909889|NCT00609973|EG000|Reported Event|Cipro|Ciprofloxacin 500 mg bid
10909890|NCT00609973|EG001|Reported Event|Placebo|Placebo bid
10909891|NCT00609986|BG000|Baseline|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
10909892|NCT00609986|BG001|Baseline|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
10909893|NCT00609986|BG002|Baseline|Total|Total of all reporting groups
10909894|NCT00609986|FG000|Participant Flow|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
11091200|NCT01533597|OG001|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
11091201|NCT01533597|EG000|Reported Event|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
10909895|NCT00609986|FG001|Participant Flow|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
11233587|NCT02429310|FG000|Participant Flow|Supervised Exercise Only|This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.
11233588|NCT02429310|FG001|Participant Flow|NMES + Supervised Exercise|"This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed.~Revitive IX: This is a neuromuscular electrical stimulation device"
11233589|NCT02429310|OG000|Outcome|Supervised Exercise Only|This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.
11233590|NCT02429310|OG001|Outcome|NMES + Supervised Exercise|"This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed.~Revitive IX: This is a neuromuscular electrical stimulation device"
11233591|NCT02429310|EG000|Reported Event|Supervised Exercise Only|This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.
11233592|NCT02429310|EG001|Reported Event|NMES + Supervised Exercise|"This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed.~Revitive IX: This is a neuromuscular electrical stimulation device"
11233593|NCT02429427|BG000|Baseline|Celecoxib|"Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.~Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice."
11233594|NCT02429427|BG001|Baseline|Placebo|"Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.~Placebo: Two capsules once daily with food"
11233595|NCT02429427|BG002|Baseline|Total|Total of all reporting groups
10909896|NCT00609986|OG000|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
10909897|NCT00609986|OG001|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
11233596|NCT02429427|FG000|Participant Flow|Celecoxib|"Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.~Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice."
11233597|NCT02429427|FG001|Participant Flow|Placebo|"Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.~Placebo: Two capsules once daily with food"
11233598|NCT02429427|OG000|Outcome|Celecoxib|"Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.~Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice."
11233599|NCT02429427|OG001|Outcome|Placebo|"Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.~Placebo: Two capsules once daily with food"
11233600|NCT02429427|EG000|Reported Event|Celecoxib|"Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.~Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice."
11091202|NCT01533597|EG001|Reported Event|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
11233601|NCT02429427|EG001|Reported Event|Placebo|"Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.~Placebo: Two capsules once daily with food"
11233602|NCT02429778|BG000|Baseline|BREATHE|"4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks.~Diaphragmatic Breathing: Deep or diaphragmatic breathing is taught prior to relaxation.~Progressive Muscle Relaxation: Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety."
11233603|NCT02429778|BG001|Baseline|Wait List|8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested.
11233604|NCT02429778|BG002|Baseline|Total|Total of all reporting groups
10909898|NCT00609986|EG000|Reported Event|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
10909899|NCT00609986|EG001|Reported Event|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
10909900|NCT00610116|BG000|Baseline|LV Lead Electronically Repositioning|"Single arm study~Electronic Repositioning: Change of pacing vectors for Cardiac Resynchronization Therapy pacing"
10909901|NCT00610116|FG000|Participant Flow|LV Lead Electronically Repositioning|Single arm study: Electronic Repositioning: Change of pacing vectors for cardiac resynchronization therapy pacing
10909902|NCT00610116|OG000|Outcome|Inducible PNS @ Max Output 7V / 0.5 ms|Patients presenting PNS at implant and subsequent follow up (between 3 and 6 months after implant)
10909903|NCT00610116|EG000|Reported Event|LV Lead Electronically Repositioning|Electronic Repositioning: Change of pacing vectors for CRT pacing
10909904|NCT00610129|BG000|Baseline|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
10909905|NCT00610129|FG000|Participant Flow|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
10909906|NCT00610129|OG000|Outcome|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
10909907|NCT00610129|EG000|Reported Event|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
10909908|NCT00610155|BG000|Baseline|Entire Study Population|Includes all participants enrolled in the study.
10909909|NCT00610155|FG000|Participant Flow|Pregabalin Then Tramadol Then Placebo|Pregabalin (PGB) capsule titrated to 150 milligram (mg) orally twice daily for 7 days in first intervention period; followed by tramadol (TMD) sustained release (SR) capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then matching placebo (PBO) capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
10909910|NCT00610155|FG001|Participant Flow|Tramadol Then Placebo Then Pregabalin|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
10909911|NCT00610155|FG002|Participant Flow|Placebo Then Pregabalin Then Tramadol|Matching placebo capsule orally for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
10909912|NCT00610155|FG003|Participant Flow|Pregabalin Then Placebo Then Tramadol|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
10909913|NCT00610155|FG004|Participant Flow|Placebo Then Tramadol Then Pregabalin|Matching placebo capsule orally for 7 days in first intervention period; followed by tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
10909914|NCT00610155|FG005|Participant Flow|Tramadol Then Pregabalin Then Placebo|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then matching placebo capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
10909915|NCT00610155|OG000|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
10909916|NCT00610155|OG001|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
10909917|NCT00610155|OG002|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
10909918|NCT00610155|EG000|Reported Event|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
10909919|NCT00610155|EG001|Reported Event|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
10909920|NCT00610155|EG002|Reported Event|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
10909921|NCT00610168|BG000|Baseline|Boostrix I Group|Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
10909922|NCT00610168|BG001|Baseline|Boostrix II Group|Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
10909923|NCT00610168|BG002|Baseline|Total|Total of all reporting groups
10909924|NCT00610168|FG000|Participant Flow|Boostrix I Group|Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
11173174|NCT02014129|FG002|Participant Flow|Cohort 3 - 200 mg Abemaciclib|200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
10909925|NCT00610168|FG001|Participant Flow|Boostrix II Group|Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
10909926|NCT00610168|OG000|Outcome|Boostrix I Group|Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
10909927|NCT00610168|OG001|Outcome|Boostrix II Group|Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
10909928|NCT00610168|OG000|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
10909929|NCT00610168|EG000|Reported Event|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
10909930|NCT00610207|BG000|Baseline|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
10909931|NCT00610207|FG000|Participant Flow|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
10909932|NCT00610207|OG000|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
10909933|NCT00610207|EG000|Reported Event|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
10909934|NCT00610311|BG000|Baseline|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
10909935|NCT00610311|FG000|Participant Flow|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
10909936|NCT00610311|OG000|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
10909937|NCT00610311|EG000|Reported Event|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
10909938|NCT00610363|BG000|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
10909939|NCT00610363|BG001|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
10909940|NCT00610363|BG002|Baseline|Total|Total of all reporting groups
10909941|NCT00610363|FG000|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 16.
10909942|NCT00610363|FG001|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
10909943|NCT00610363|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
10909944|NCT00610363|OG001|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
10909945|NCT00610363|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
10909946|NCT00610363|EG000|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
10909947|NCT00610363|EG001|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
10909948|NCT00610428|BG000|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
10909949|NCT00610428|BG001|Baseline|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
10909950|NCT00610428|BG002|Baseline|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
10909951|NCT00610428|BG003|Baseline|Total|Total of all reporting groups
10909952|NCT00610428|FG000|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
10909953|NCT00610428|FG001|Participant Flow|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
10909954|NCT00610428|FG002|Participant Flow|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
10909955|NCT00610428|OG000|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
10909956|NCT00610428|OG001|Outcome|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
10909957|NCT00610428|OG002|Outcome|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
10909958|NCT00610428|EG000|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
10909959|NCT00610428|EG001|Reported Event|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
10909960|NCT00610428|EG002|Reported Event|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
10909961|NCT00610441|BG000|Baseline|MK-8777 FD→PBO|Participants receive a fixed dose FD of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
10909962|NCT00610441|BG001|Baseline|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
10909963|NCT00610441|BG002|Baseline|MK-8777 RD→PBO|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
10909964|NCT00610441|BG003|Baseline|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
10909965|NCT00610441|BG004|Baseline|Total|Total of all reporting groups
10909966|NCT00610441|FG000|Participant Flow|MK-8777 FD→PBO|Participants receive a fixed dose (FD) of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
10909967|NCT00610441|FG001|Participant Flow|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
10909968|NCT00610441|FG002|Participant Flow|MK-8777 RD→PBO|Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
10909969|NCT00610441|FG003|Participant Flow|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
10909970|NCT00610441|OG000|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
10909971|NCT00610441|OG001|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
10909972|NCT00610441|OG002|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
10909973|NCT00610441|OG003|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
10909974|NCT00610441|OG000|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
10909975|NCT00610441|OG001|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
10909976|NCT00610441|OG002|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
10909977|NCT00610441|EG000|Reported Event|Placebo|Participants receive placebo BID for up to 5 weeks.
10909978|NCT00610441|EG001|Reported Event|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for up to 3 weeks.
10909979|NCT00610441|EG002|Reported Event|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for up to 3 weeks.
10909980|NCT00610480|BG000|Baseline|Optive, Then Systane|Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Systane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.
11091203|NCT01533688|BG000|Baseline|Golytely + Placebo|"4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill~Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy"
10909981|NCT00610480|BG001|Baseline|Systane, Then Optive|Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.
10909982|NCT00610480|BG002|Baseline|Total|Total of all reporting groups
10909983|NCT00610480|FG000|Participant Flow|Optive, Then Systane Artificial Tears|Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Systane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.
10909984|NCT00610480|FG001|Participant Flow|Systane, Then Optane Artificial Tears|Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.
10909985|NCT00610480|OG000|Outcome|Optive Artificial Tears|Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Systane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.
10909986|NCT00610480|OG001|Outcome|Systane Artificial Tears|"Artificial Tear~Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later."
10909987|NCT00610480|EG000|Reported Event|Optive Artificial Tears|Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later.
10909988|NCT00610480|EG001|Reported Event|Systane Artificial Tears|Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later.
10909989|NCT00610649|BG000|Baseline|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
10909990|NCT00610649|BG001|Baseline|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
11091204|NCT01533688|BG001|Baseline|Golytely Split + Placebo|"split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill~split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo"
11091205|NCT01533688|BG002|Baseline|Golytely Split + Bisacodyl|"split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg~split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg"
11091206|NCT01533688|BG003|Baseline|Total|Total of all reporting groups
11091207|NCT01533688|FG000|Participant Flow|Golytely + Placebo|"4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill~Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy"
11091208|NCT01533688|FG001|Participant Flow|Golytely Split + Placebo|"split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill~split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo"
11091209|NCT01533688|FG002|Participant Flow|Golytely Split + Bisacodyl|"split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg~split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg"
11091210|NCT01533688|OG000|Outcome|Golytely + Placebo|"4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill~Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy"
11173175|NCT02014129|OG000|Outcome|Cohort 1 - 100 mg Abemaciclib|100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
10909991|NCT00610649|BG002|Baseline|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
10909992|NCT00610649|BG003|Baseline|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
10909993|NCT00610649|BG004|Baseline|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
10909994|NCT00610649|BG005|Baseline|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
10909995|NCT00610649|BG006|Baseline|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
10909996|NCT00610649|BG007|Baseline|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
10909997|NCT00610649|BG008|Baseline|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
10909998|NCT00610649|BG009|Baseline|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
10909999|NCT00610649|BG010|Baseline|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
10910000|NCT00610649|BG011|Baseline|Total|Total of all reporting groups
10910001|NCT00610649|FG000|Participant Flow|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
10910002|NCT00610649|FG001|Participant Flow|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
10910003|NCT00610649|FG002|Participant Flow|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
10910004|NCT00610649|FG003|Participant Flow|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
10910005|NCT00610649|FG004|Participant Flow|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
10910006|NCT00610649|FG005|Participant Flow|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
11173176|NCT02014129|OG001|Outcome|Cohort 2 - 150 mg Abemaciclib|150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
10910007|NCT00610649|FG006|Participant Flow|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
10910008|NCT00610649|FG007|Participant Flow|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
10910009|NCT00610649|FG008|Participant Flow|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg once daily (QD). Participants receive MK-8777 for a total of 28 days.
10910010|NCT00610649|FG009|Participant Flow|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
10910011|NCT00610649|FG010|Participant Flow|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
10910012|NCT00610649|OG000|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
10910013|NCT00610649|OG001|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
10910014|NCT00610649|OG002|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
10910015|NCT00610649|OG003|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
10910016|NCT00610649|OG004|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
10910017|NCT00610649|OG005|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
10910018|NCT00610649|OG006|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
10910019|NCT00610649|OG007|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
10910020|NCT00610649|OG000|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
10910021|NCT00610649|OG001|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
10910022|NCT00610649|OG002|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
10910023|NCT00610649|EG000|Reported Event|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
10910024|NCT00610649|EG001|Reported Event|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
10910025|NCT00610649|EG002|Reported Event|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
10910026|NCT00610649|EG003|Reported Event|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
10910027|NCT00610649|EG004|Reported Event|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
10910028|NCT00610649|EG005|Reported Event|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
10910029|NCT00610649|EG006|Reported Event|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
10910030|NCT00610649|EG007|Reported Event|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
11173177|NCT02014129|OG002|Outcome|Cohort 3 - 200 mg Abemaciclib|200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
11173178|NCT02014129|EG000|Reported Event|Cohort 1 - 100 mg Abemaciclib|100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
11173179|NCT02014129|EG001|Reported Event|Cohort 2 - 150 mg Abemaciclib|150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
10910031|NCT00610649|EG008|Reported Event|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
10910032|NCT00610649|EG009|Reported Event|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
10910033|NCT00610649|EG010|Reported Event|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
10910034|NCT00610675|BG000|Baseline|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
10910035|NCT00610675|FG000|Participant Flow|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
10910036|NCT00610675|OG000|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
10910037|NCT00610675|EG000|Reported Event|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
10910038|NCT00610688|BG000|Baseline|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
10910039|NCT00610688|BG001|Baseline|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
10910040|NCT00610688|BG002|Baseline|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
10910041|NCT00610688|BG003|Baseline|Total|Total of all reporting groups
10910042|NCT00610688|FG000|Participant Flow|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
10910043|NCT00610688|FG001|Participant Flow|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
10910044|NCT00610688|FG002|Participant Flow|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
10910045|NCT00610688|OG000|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
10910046|NCT00610688|OG001|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
10910047|NCT00610688|OG002|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
10910048|NCT00610688|EG000|Reported Event|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
10910049|NCT00610688|EG001|Reported Event|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
10910050|NCT00610688|EG002|Reported Event|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
10910051|NCT00610701|BG000|Baseline|1-anterior Pin Placement|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
10910052|NCT00610701|BG001|Baseline|2-lateral Pin Placement|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
10910053|NCT00610701|BG002|Baseline|Total|Total of all reporting groups
10910054|NCT00610701|FG000|Participant Flow|1 Anterior|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
10910055|NCT00610701|FG001|Participant Flow|2 Lateral|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
10910056|NCT00610701|OG000|Outcome|1-anterior Pin Placement|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
10910057|NCT00610701|OG001|Outcome|2-lateral Pin Placement|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
10910058|NCT00610701|EG000|Reported Event|1 Anterior|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
10910059|NCT00610701|EG001|Reported Event|2 Lateral|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
10910060|NCT00610714|BG000|Baseline|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
10910061|NCT00610714|BG001|Baseline|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
10910062|NCT00610714|BG002|Baseline|Total|Total of all reporting groups
10910063|NCT00610714|FG000|Participant Flow|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
10910064|NCT00610714|FG001|Participant Flow|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
10910065|NCT00610714|OG000|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
10910066|NCT00610714|OG001|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
10910067|NCT00610714|EG000|Reported Event|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
10910068|NCT00610714|EG001|Reported Event|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
11357166|NCT03763929|FG000|Participant Flow|Trans Sodium Crocetinate|"Trans sodium crocetinate (TSC) will be administered intravenously as a bolus to subjects randomized to experimental drug. The bolus dose will consist of 0.25 mg/kg of TSC based on the estimated subject weight.~Trans-Sodium Crocetinate: In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance."
11357167|NCT03763929|FG001|Participant Flow|Placebo|"The placebo consists of commercially available sterile saline. Placebo will be administered intravenously as a bolus to subjects randomized to placebo. The volume of sterile saline will be based on the estimated subject weight.~Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance."
11357168|NCT03763929|OG000|Outcome|Trans Sodium Crocetinate|"Trans sodium crocetinate (TSC) will be administered intravenously as a bolus to subjects randomized to experimental drug. The bolus dose will consist of 0.25 mg/kg of TSC based on the estimated subject weight.~Trans-Sodium Crocetinate: In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance."
11357169|NCT03763929|OG001|Outcome|Placebo|"The placebo consists of commercially available sterile saline. Placebo will be administered intravenously as a bolus to subjects randomized to placebo. The volume of sterile saline will be based on the estimated subject weight.~Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance."
11357170|NCT03763929|EG000|Reported Event|Trans Sodium Crocetinate|"Trans sodium crocetinate (TSC) will be administered intravenously as a bolus to subjects randomized to experimental drug. The bolus dose will consist of 0.25 mg/kg of TSC based on the estimated subject weight.~Trans-Sodium Crocetinate: In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance."
10910069|NCT00610727|BG000|Baseline|Qualification & Crossover, Inhaled Prochlorperazine vs IV|"Prochlorperazine 10 mg IV over 2 min qualification~Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg~ALL SUBJECTS RECEIVED ALL 3 TREATMENTS"
10910070|NCT00610727|BG001|Baseline|Inhaled Prochlorperazine 1.25 mg|"Inhaled Staccato prochlorperazine 1.25 mg~Inhaled prochlorperazine 1.25 mg: Inhaled Staccato Prochlorperazine 1.25 mg"
10910071|NCT00610727|BG002|Baseline|Inhaled Prochlorperazine 2.5 mg|"Inhaled Staccato prochlorperazine 2.5 mg~Inhaled prochlorperazine 2.5 mg: Inhaled Staccato Prochlorperazine 2.5 mg"
10910072|NCT00610727|BG003|Baseline|Inhaled Prochlorperazine 5 mg|"Inhaled Staccato prochlorperazine 5 mg~Inhaled prochlorperazine 5 mg: InhaledStaccato Prochlorperazine 5 mg"
10910073|NCT00610727|BG004|Baseline|Inhaled Prochlorperazine 10 mg|"Inhaled Staccato prochlorperazine 10 mg~Inhaled prochlorperazine 10 mg: InhaledStaccato Prochlorperazine 10 mg"
10910074|NCT00610727|BG005|Baseline|Inhaled Placebo|"inhaled Staccato Placebo (0 mg)~Inhaled placebo: Inhaled Staccato Placebo (0 mg)"
10910075|NCT00610727|BG006|Baseline|Total|Total of all reporting groups
10910076|NCT00610727|FG000|Participant Flow|Qualification & Crossover Arm, Inhaled Prochlorperazine vs IV|"Prochlorperazine 10 mg IV over 2 min qualification~Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg~ALL SUBJECTS RECEIVED ALL TREATMENT"
10910077|NCT00610727|FG001|Participant Flow|Inhaled Prochlorperazine 1.25 mg|"Inhaled Staccato prochlorperazine 1.25 mg~Inhaled prochlorperazine 1.25 mg: Inhaled Staccato Prochlorperazine 1.25 mg"
10910078|NCT00610727|FG002|Participant Flow|Inhaled Prochlorperazine 2.5 mg|"Inhaled Staccato prochlorperazine 2.5 mg~Inhaled prochlorperazine 2.5 mg: Inhaled Staccato Prochlorperazine 2.5 mg"
11091211|NCT01533688|OG001|Outcome|Golytely Split + Placebo|"split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill~split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo"
11091212|NCT01533688|OG002|Outcome|Golytely Split + Bisacodyl|"split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg~split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg"
11091213|NCT01533688|OG001|Outcome|Golytely Split+Placebo|"split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill~split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo"
11091214|NCT01533688|OG002|Outcome|Golytely Split+Bisacodyl|"split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg~split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg"
11091215|NCT01533688|EG000|Reported Event|Golytely + Placebo|"4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill~Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy"
11091216|NCT01533688|EG001|Reported Event|Golytely Split + Placebo|"split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill~split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo"
11091217|NCT01533688|EG002|Reported Event|Golytely Split + Bisacodyl|"split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg~split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg"
10910079|NCT00610727|FG003|Participant Flow|Inhaled Prochlorperazine 5 mg|"Inhaled Staccato prochlorperazine 5 mg~Inhaled prochlorperazine 5 mg: InhaledStaccato Prochlorperazine 5 mg"
10910080|NCT00610727|FG004|Participant Flow|Inhaled Prochlorperazine 10 mg|"Inhaled Staccato prochlorperazine 10 mg~Inhaled prochlorperazine 10 mg: InhaledStaccato Prochlorperazine 10 mg"
10910081|NCT00610727|FG005|Participant Flow|Inhaled Placebo|"inhaled Staccato Placebo (0 mg)~Inhaled placebo: Inhaled Staccato Placebo (0 mg)"
10910082|NCT00610727|OG000|Outcome|0.5 mg 5 Sec IV|0.5 mg 5 sec IV prochlorperazine
10910083|NCT00610727|OG001|Outcome|0.625 mg Inhaled Prochlorperazine|0.625 mg Inhaled prochlorperazine
10910084|NCT00610727|OG002|Outcome|1.25 mg Inhaled|1.25 mg Inhaled Prochlorperazine
10910085|NCT00610727|OG003|Outcome|2.5 mg Inhaled|2.5 mg Inhaled Prochlorperazine
10910086|NCT00610727|OG004|Outcome|5 mg Inhaled|5 mg Inhaled Prochlorperazine
10910087|NCT00610727|OG005|Outcome|10 mg Inhaled|10 mg Inhaled Prochlorperazine
10910088|NCT00610727|OG000|Outcome|Bioavailability Crossover Arm|0.625 mg prochlorperazine crossover 0.5 mg via 5-second IV prochlorperazine
10910089|NCT00610727|OG000|Outcome|All Subjects Receiving Inhaled Prochloperazine|0.625 mg, 8 subjects 1.25 mg, 8 subjects 2.5 mg, 8 subjects 5 mg, 8 subjects 10 mg, 8 subjects
10910090|NCT00610727|EG000|Reported Event|IV Prochlorperazine 10 mg|Intravenous prochlorperazine 10 mg
10910091|NCT00610727|EG001|Reported Event|IV Prochlorperazine 0.5 mg|Intravenous prochlorperazine 0.5 mg
10910092|NCT00610727|EG002|Reported Event|Inhaled Prochlorperazine 0.625|Inhaled prochlorperazine 0.625 mg
10910093|NCT00610727|EG003|Reported Event|Inhaled Prochlorperazine 1.25 mg|Inhaled Staccato prochlorperazine 1.25 mg
10910094|NCT00610727|EG004|Reported Event|Inhaled Prochlorperazine 2.5 mg|Inhaled Staccato prochlorperazine 2.5 mg
10910095|NCT00610727|EG005|Reported Event|Inhaled Prochlorperazine 5 mg|Inhaled Staccato prochlorperazine 5 mg
10910096|NCT00610727|EG006|Reported Event|Inhaled Prochlorperazine 10 mg|Inhaled Staccato prochlorperazine 10 mg
10910097|NCT00610727|EG007|Reported Event|Inhaled Placebo|inhaled Staccato Placebo (0 mg)
10910098|NCT00610740|BG000|Baseline|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
10910099|NCT00610740|FG000|Participant Flow|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
10910100|NCT00610740|OG000|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
10910101|NCT00610740|EG000|Reported Event|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
10910102|NCT00610857|BG000|Baseline|Interferon Alfa-2b + Tremelimumab|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
10910103|NCT00610857|FG000|Participant Flow|Interferon Alfa-2b + Tremelimumab|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy
10910104|NCT00610857|OG000|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
10910105|NCT00610857|EG000|Reported Event|Interferon Alfa-2b + Tremelimumab (Related and Unrelated AEs)|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks per cycle.
10910106|NCT00610883|BG000|Baseline|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
10910107|NCT00610883|FG000|Participant Flow|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
10910108|NCT00610883|OG000|Outcome|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
10910109|NCT00610883|EG000|Reported Event|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
10910110|NCT00610935|BG000|Baseline|Placebo|Placebo intramuscular injection
10910111|NCT00610935|BG001|Baseline|Peramivir|Single intramuscular injection of 300mg peramivir
10910112|NCT00610935|BG002|Baseline|Total|Total of all reporting groups
10910113|NCT00610935|FG000|Participant Flow|Placebo|Placebo intramuscular injection
10910114|NCT00610935|FG001|Participant Flow|Peramivir|Single intramuscular injection of 300mg peramivir
10910115|NCT00610935|OG000|Outcome|Placebo|Placebo intramuscular injection
10910116|NCT00610935|OG001|Outcome|Peramivir|Single intramuscular injection of 300mg peramivir
10910117|NCT00610935|EG000|Reported Event|Placebo|Placebo intramuscular injection
10910118|NCT00610935|EG001|Reported Event|Peramivir|Single intramuscular injection of 300mg peramivir
10910119|NCT00610987|BG000|Baseline|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
10910120|NCT00610987|BG001|Baseline|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
10910121|NCT00610987|BG002|Baseline|Total|Total of all reporting groups
10910122|NCT00610987|FG000|Participant Flow|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
10910123|NCT00610987|FG001|Participant Flow|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
10910124|NCT00610987|OG000|Outcome|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
10910125|NCT00610987|OG001|Outcome|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
10910126|NCT00610987|EG000|Reported Event|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
10910127|NCT00610987|EG001|Reported Event|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
10910128|NCT00611026|BG000|Baseline|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
10910129|NCT00611026|BG001|Baseline|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
10910130|NCT00611026|BG002|Baseline|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
10910131|NCT00611026|BG003|Baseline|Total|Total of all reporting groups
11173180|NCT02014129|EG002|Reported Event|Cohort 3 - 200 mg Abemaciclib|200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
10910132|NCT00611026|FG000|Participant Flow|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
10910133|NCT00611026|FG001|Participant Flow|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
10910134|NCT00611026|FG002|Participant Flow|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
11173181|NCT02014272|BG000|Baseline|Entire Study Population|Includes all participants randomized to receive RIN 150 first and rifampicin and isoniazid first.
10910135|NCT00611026|OG000|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
10910136|NCT00611026|OG001|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
10910137|NCT00611026|OG002|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
10910138|NCT00611026|OG000|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
10910139|NCT00611026|OG001|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
10910140|NCT00611026|EG000|Reported Event|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
10910141|NCT00611026|EG001|Reported Event|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
10910142|NCT00611026|EG002|Reported Event|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
10910143|NCT00611130|BG000|Baseline|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
10910144|NCT00611130|BG001|Baseline|Placebo|Matching Placebo Tablets. 3 tablets bid.
10910145|NCT00611130|BG002|Baseline|Total|Total of all reporting groups
10910146|NCT00611130|FG000|Participant Flow|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
10910147|NCT00611130|FG001|Participant Flow|Placebo|Matching Placebo Tablets. 3 tablets bid.
10910148|NCT00611130|OG000|Outcome|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks, computerized cognitive behavioral therapy plus contingency management.Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin) and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) for efficacy and safety assessments and for treatment during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
10910149|NCT00611130|OG001|Outcome|Matching Placebo Tablets|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
10910150|NCT00611130|OG000|Outcome|Treatment Phase Completers|Up to 12 urine specimens out of 37 collected during the Treatment Phase completers were analyzed for vigabatrin levels.
10910151|NCT00611130|EG000|Reported Event|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
10910152|NCT00611130|EG001|Reported Event|Matching Placebo Tablet|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
11342178|NCT03700372|BG000|Baseline|IOWA Approach Cardiac Ablation|"Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation.~IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System"
10910153|NCT00611247|BG000|Baseline|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910154|NCT00611247|BG001|Baseline|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910155|NCT00611247|BG002|Baseline|Total|Total of all reporting groups
10910156|NCT00611247|FG000|Participant Flow|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910157|NCT00611247|FG001|Participant Flow|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910158|NCT00611247|OG000|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910159|NCT00611247|OG001|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910160|NCT00611247|OG001|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910161|NCT00611247|EG000|Reported Event|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910162|NCT00611247|EG001|Reported Event|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
10910163|NCT00611325|BG000|Baseline|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
10910164|NCT00611325|BG001|Baseline|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
10910165|NCT00611325|BG002|Baseline|Total|Total of all reporting groups
10910166|NCT00611325|FG000|Participant Flow|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
10910167|NCT00611325|FG001|Participant Flow|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
10910168|NCT00611325|OG000|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
10910169|NCT00611325|OG001|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
11173182|NCT02014272|FG000|Participant Flow|RIN 150 First, Then Rifampicin and Isoniazid|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contained 150 milligram [mg] rifampicin and 75 mg isoniazid) on Day 1 in first intervention period, followed by single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
11173183|NCT02014272|FG001|Participant Flow|Rifampicin and Isoniazid First, Then RIN 150|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in first intervention period followed by single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
11173184|NCT02014272|OG000|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
11173185|NCT02014272|OG001|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
11173186|NCT02014272|EG000|Reported Event|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
11173187|NCT02014272|EG001|Reported Event|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
11173188|NCT02014363|BG000|Baseline|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
11173189|NCT02014363|BG001|Baseline|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
11173190|NCT02014363|BG002|Baseline|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
11173191|NCT02014363|BG003|Baseline|Total|Total of all reporting groups
11173192|NCT02014363|FG000|Participant Flow|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
11173193|NCT02014363|FG001|Participant Flow|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
11173194|NCT02014363|FG002|Participant Flow|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
11173195|NCT02014363|OG000|Outcome|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
11173196|NCT02014363|OG001|Outcome|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
10910170|NCT00611325|EG000|Reported Event|EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.~Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 2.5 mg/m2 for patients taking EIAEDs."
10910171|NCT00611325|EG001|Reported Event|Non-EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.~Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 1.7 mg/m2 for patients not taking EIAEDs."
10910172|NCT00611351|BG000|Baseline|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
10910173|NCT00611351|FG000|Participant Flow|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
11173197|NCT02014363|OG002|Outcome|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
11173198|NCT02014363|EG000|Reported Event|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
11173199|NCT02014363|EG001|Reported Event|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
11173200|NCT02014363|EG002|Reported Event|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
11173201|NCT02014376|BG000|Baseline|SD-101 Dermal Cream (6%)|SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
11173202|NCT02014376|BG001|Baseline|SD-101 Dermal Cream (3%)|SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
11173203|NCT02014376|BG002|Baseline|Vehicle (0%)|Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
11173204|NCT02014376|BG003|Baseline|Total|Total of all reporting groups
11173205|NCT02014376|FG000|Participant Flow|SD-101 Dermal Cream (6%)|SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
11173206|NCT02014376|FG001|Participant Flow|SD-101 Dermal Cream (3%)|SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
11173207|NCT02014376|FG002|Participant Flow|Vehicle (0%)|Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
10910174|NCT00611351|OG000|Outcome|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
10910175|NCT00611351|EG000|Reported Event|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
10910176|NCT00611403|BG000|Baseline|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
10910177|NCT00611403|BG001|Baseline|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
10910178|NCT00611403|BG002|Baseline|Total|Total of all reporting groups
10910179|NCT00611403|FG000|Participant Flow|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
10910180|NCT00611403|FG001|Participant Flow|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
10910181|NCT00611403|OG000|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
10910182|NCT00611403|OG001|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
10910183|NCT00611403|EG000|Reported Event|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
10910184|NCT00611403|EG001|Reported Event|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
10910185|NCT00611442|BG000|Baseline|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
10910186|NCT00611442|BG001|Baseline|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
10910187|NCT00611442|BG002|Baseline|Total|Total of all reporting groups
10910188|NCT00611442|FG000|Participant Flow|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
10910189|NCT00611442|FG001|Participant Flow|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
11173208|NCT02014376|OG000|Outcome|SD-101 Dermal Cream (6%)|SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
10910190|NCT00611442|OG000|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
10910191|NCT00611442|OG001|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
11091218|NCT01533922|BG000|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The 5 treatments, administered orally via the respimat inhaler, once daily, in the morning were:~Oral inhalation of placebo~Olodaterol fixed dose 5 µg~Tiotropium fixed dose 5 µg~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
10910192|NCT00611442|EG000|Reported Event|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
10910193|NCT00611442|EG001|Reported Event|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
10910194|NCT00611455|BG000|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10910195|NCT00611455|BG001|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10910196|NCT00611455|BG002|Baseline|Total|Total of all reporting groups
10910197|NCT00611455|FG000|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
10910198|NCT00611455|FG001|Participant Flow|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
10910199|NCT00611455|FG002|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
10910200|NCT00611455|OG000|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10910201|NCT00611455|OG001|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
10910202|NCT00611455|OG000|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
10910203|NCT00611455|OG001|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
11173209|NCT02014376|OG001|Outcome|SD-101 Dermal Cream (3%)|SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
10910204|NCT00611455|OG002|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
10910205|NCT00611455|EG000|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
10910206|NCT00611455|EG001|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
10910207|NCT00611455|EG002|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
10910208|NCT00611468|BG000|Baseline|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
10910209|NCT00611468|FG000|Participant Flow|Dosage Level 1 for MTD Determination|Dosage level 1 was topotecan 0.75 mg/m2 and erlotinib 150 mg.
10910210|NCT00611468|FG001|Participant Flow|Dosage Level 2 for MTD Determination|Dosage level 2 was topotecan 1.0 mg/m2 and erlotinib 150 mg.
10910211|NCT00611468|FG002|Participant Flow|Dosage Level 3 for MTD Determination|Dosage level 3 was topotecan 1.25 mg/m2 and erlotinib 150 mg.
10910212|NCT00611468|FG003|Participant Flow|PK Group for Additional PK Data|Additional patients were enrolled for enhanced PK parameter estimation
10910213|NCT00611468|OG000|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
11091219|NCT01533922|FG000|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg"
11091220|NCT01533922|FG001|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo"
11091221|NCT01533922|FG002|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
11091222|NCT01533922|FG003|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
11091223|NCT01533922|FG004|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg"
11091224|NCT01533922|OG000|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
11091225|NCT01533922|OG001|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091226|NCT01533922|OG002|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091227|NCT01533922|OG003|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10910214|NCT00611468|EG000|Reported Event|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
11173210|NCT02014376|OG002|Outcome|Vehicle (0%)|Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
10910215|NCT00611533|BG000|Baseline|All Study Participants|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
11173211|NCT02014376|EG000|Reported Event|SD-101 Dermal Cream (6%)|SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
10910216|NCT00611533|FG000|Participant Flow|Atomoxetine Then Placebo|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
10910217|NCT00611533|FG001|Participant Flow|Placebo Then Atomoxetine|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
10910218|NCT00611533|OG000|Outcome|Baseline|
10910219|NCT00611533|OG001|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
10910220|NCT00611533|OG002|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
10910221|NCT00611533|EG000|Reported Event|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
10910222|NCT00611533|EG001|Reported Event|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
10910223|NCT00611559|BG000|Baseline|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
10910224|NCT00611559|BG001|Baseline|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
10910225|NCT00611559|BG002|Baseline|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix penta
10910226|NCT00611559|BG003|Baseline|Total|Total of all reporting groups
10910227|NCT00611559|FG000|Participant Flow|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
10910228|NCT00611559|FG001|Participant Flow|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
10910229|NCT00611559|FG002|Participant Flow|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix penta
10910230|NCT00611559|OG000|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
10910231|NCT00611559|OG001|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
10910232|NCT00611559|OG002|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix penta
10910233|NCT00611559|EG000|Reported Event|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
10910234|NCT00611559|EG001|Reported Event|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
10910235|NCT00611559|EG002|Reported Event|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix penta
10910236|NCT00611624|BG000|Baseline|Five Days of Mammosite Therapy|
10910237|NCT00611624|FG000|Participant Flow|Five Days of Mammosite Therapy|Five Days of Mammosite Therapy (Radiotherapy)
10910238|NCT00611624|OG000|Outcome|Five Days of Mammosite Therapy|
10910239|NCT00611624|OG000|Outcome|Patient Characteristics|Twenty-eight women in total were enrolled and had been treated on this trial at the time of analysis (12 additional patients accrued after the initial phase of 16 patients).
10910240|NCT00611624|EG000|Reported Event|Five Days of Mammosite Therapy|
10915142|NCT00634166|BG000|Baseline|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
10915143|NCT00634166|BG001|Baseline|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
10915144|NCT00634166|BG002|Baseline|Total|Total of all reporting groups
11091228|NCT01533922|OG004|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091229|NCT01533922|EG000|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
10910241|NCT00611715|BG000|Baseline|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
10910242|NCT00611715|BG001|Baseline|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
10910243|NCT00611715|BG002|Baseline|Total|Total of all reporting groups
10910244|NCT00611715|FG000|Participant Flow|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
10910245|NCT00611715|FG001|Participant Flow|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
10910246|NCT00611715|OG000|Outcome|Hormone Therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
10910247|NCT00611715|OG001|Outcome|Previous Hormone Therapy|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
10910248|NCT00611715|OG000|Outcome|First Line/Hormone-therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
10910249|NCT00611715|OG001|Outcome|Second-line/Prev Hormone-therapy tx|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
10910250|NCT00611715|OG000|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naive in the metastatic setting and more than 12 months from adjuvant endocrine therapy
10910251|NCT00611715|OG001|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy
10910252|NCT00611715|OG000|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
10910253|NCT00611715|OG001|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
10910254|NCT00611715|EG000|Reported Event|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
10910255|NCT00611715|EG001|Reported Event|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
10910256|NCT00611767|BG000|Baseline|Family History Negative for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
10910257|NCT00611767|BG001|Baseline|Family History Positive for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.
10910258|NCT00611767|BG002|Baseline|Total|Total of all reporting groups
10910259|NCT00611767|FG000|Participant Flow|Family History Negative for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
10910260|NCT00611767|FG001|Participant Flow|Family History Positive for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by The Collaborative Study on the Genetics of Alcoholism (COGA).
10910261|NCT00611767|OG000|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
10910262|NCT00611767|OG001|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
10910263|NCT00611767|EG000|Reported Event|Family History Negative for Alcoholism|"Family History Negative for Alcoholism subjects will receive 2 interventions~Thiopental: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion)."
10910264|NCT00611767|EG001|Reported Event|Family History Positive for Alcoholism|"Family History Positive for Alcoholism subjects will receive 2 interventions~Placebo: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion)."
10910265|NCT00611806|BG000|Baseline|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
10910266|NCT00611806|BG001|Baseline|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
10910267|NCT00611806|BG002|Baseline|Total|Total of all reporting groups
10910268|NCT00611806|FG000|Participant Flow|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
10910269|NCT00611806|FG001|Participant Flow|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
10910270|NCT00611806|OG000|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
10910271|NCT00611806|OG001|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
10910272|NCT00611806|EG000|Reported Event|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
10910273|NCT00611806|EG001|Reported Event|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
10910274|NCT00611858|BG000|Baseline|Cetuximab With Standard 5-FU and Radiation|"Cetuximab: Participants first receive cetuximab at the initial dose of 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Cetuximab is given as single agent during the first 3 weeks on study and then in combination with 5-FU and radiation.~Radiation: Radiation therapy given as standard of care is initiated after the 3rd dose of cetuximab with a total dose of 50.4 Gray (Gy) in 28 fractions over approximately 5.5 weeks.~5-FU: Participants receive 5-Fluorouracil (5-FU) continuous infusion through central venous access at 225 mg/m2/day given 7 days a week starting day 1 of radiation (no later than 3 days) and lasting the duration of radiation therapy.~Duration of neoadjuvant therapy is estimated to be 9 weeks. Surgery follows at week 13-17. Sigmoidoscopy is performed for biopsy prior to the 1st dose and after 3rd dose of cetuximab before the initiation of radiation and/or 5-FU."
10910275|NCT00611858|FG000|Participant Flow|Cetuximab With Standard 5-FU and Radiation|"Cetuximab: Participants first receive cetuximab at the initial dose of 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Cetuximab is given as single agent during the first 3 weeks on study and then in combination with 5-FU and radiation.~Radiation: Radiation therapy given as standard of care is initiated after the 3rd dose of cetuximab with a total dose of 50.4 Gray (Gy) in 28 fractions over approximately 5.5 weeks.~5-FU: Participants receive 5-Fluorouracil (5-FU) continuous infusion through central venous access at 225 mg/m2/day given 7 days a week starting day 1 of radiation (no later than 3 days) and lasting the duration of radiation therapy.~Duration of neoadjuvant therapy is estimated to be 9 weeks. Surgery follows at week 13-17. Sigmoidoscopy is performed for biopsy prior to the 1st dose and after 3rd dose of cetuximab before the initiation of radiation and/or 5-FU."
10910276|NCT00611858|OG000|Outcome|Cetuximab With Standard 5-FU and Radiation|Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
10910277|NCT00611858|OG000|Outcome|Cetuximab With Standard 5-FU and Radiation|"Cetuximab: Participants first receive cetuximab at the initial dose of 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Cetuximab is given as single agent during the first 3 weeks on study and then in combination with 5-FU and radiation.~Radiation: Radiation therapy given as standard of care is initiated after the 3rd dose of cetuximab with a total dose of 50.4 Gray (Gy) in 28 fractions over approximately 5.5 weeks.~5-FU: Participants receive 5-Fluorouracil (5-FU) continuous infusion through central venous access at 225 mg/m2/day given 7 days a week starting day 1 of radiation (no later than 3 days) and lasting the duration of radiation therapy.~Duration of neoadjuvant therapy is estimated to be 9 weeks. Surgery follows at week 13-17. Sigmoidoscopy is performed for biopsy prior to the 1st dose and after 3rd dose of cetuximab before the initiation of radiation and/or 5-FU."
10910278|NCT00611858|OG000|Outcome|Cetuximab, 5-FU and Radiation|"Cetuximab: Participants first receive cetuximab at the initial dose of 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Cetuximab is given as single agent during the first 3 weeks on study and then in combination with 5-FU and radiation.~Radiation: Radiation therapy given as standard of care is initiated after the 3rd dose of cetuximab with a total dose of 50.4 Gray (Gy) in 28 fractions over approximately 5.5 weeks.~5-FU: Participants receive 5-Fluorouracil (5-FU) continuous infusion through central venous access at 225 mg/m2/day given 7 days a week starting day 1 of radiation (no later than 3 days) and lasting the duration of radiation therapy.~Duration of neoadjuvant therapy is estimated to be 9 weeks. Surgery follows at week 13-17. Sigmoidoscopy is performed for biopsy prior to the 1st dose and after 3rd dose of cetuximab before the initiation of radiation and/or 5-FU."
10910279|NCT00611858|EG000|Reported Event|Cetuximab With Standard 5-FU and Radiation|Patients with stage II/III rectal cancer who have received cetuximab with standard 5-FU and radiation as neoadjuvant therapy.
10910280|NCT00611884|BG000|Baseline|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
10910281|NCT00611884|BG001|Baseline|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
10910282|NCT00611884|BG002|Baseline|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
10910283|NCT00611884|BG003|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
10910284|NCT00611884|BG004|Baseline|Total|Total of all reporting groups
10910285|NCT00611884|FG000|Participant Flow|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
10910286|NCT00611884|FG001|Participant Flow|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
10910287|NCT00611884|FG002|Participant Flow|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
10910288|NCT00611884|FG003|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
10910289|NCT00611884|OG000|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
10910290|NCT00611884|OG001|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
10910291|NCT00611884|OG002|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
10910292|NCT00611884|OG003|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
10910293|NCT00611884|EG000|Reported Event|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
10910294|NCT00611884|EG001|Reported Event|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
10910295|NCT00611884|EG002|Reported Event|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
10910296|NCT00611884|EG003|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
10910297|NCT00611897|BG000|Baseline|Overall Sample|This is the group of healthy volunteers that consented to participate in the study.
10910298|NCT00611897|FG000|Participant Flow|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
10910299|NCT00611897|FG001|Participant Flow|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
10910300|NCT00611897|OG000|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
10910301|NCT00611897|OG001|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
10910302|NCT00611897|OG002|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
10910303|NCT00611897|OG003|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
11173212|NCT02014376|EG001|Reported Event|SD-101 Dermal Cream (3%)|SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
10910304|NCT00611897|EG000|Reported Event|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
10910305|NCT00611897|EG001|Reported Event|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
10910306|NCT00611923|BG000|Baseline|Placebo|"Participants will take placebo flutamide~Placebo: Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day."
10910307|NCT00611923|BG001|Baseline|Flutamide|"Participants will take flutamide~Flutamide: Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day."
10910308|NCT00611923|BG002|Baseline|Total|Total of all reporting groups
10910309|NCT00611923|FG000|Participant Flow|Placebo|"Participants will take placebo flutamide~Placebo: Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day."
10910310|NCT00611923|FG001|Participant Flow|Flutamide|"Participants will take flutamide~Flutamide: Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day."
10910311|NCT00611923|OG000|Outcome|Placebo|Placebo: Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
10910312|NCT00611923|OG001|Outcome|Flutamide|Flutamide: Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
10910313|NCT00611923|OG000|Outcome|Placebo|"Participants will take placebo flutamide~Placebo: Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day."
10910314|NCT00611923|OG001|Outcome|Flutamide|"Participants will take flutamide~Flutamide: Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day."
10910315|NCT00611923|EG000|Reported Event|Placebo|Placebo: Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
10910316|NCT00611923|EG001|Reported Event|Flutamide|Flutamide: Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
10910317|NCT00611975|BG000|Baseline|Fluoxetine|"Participants will receive treatment with fluoxetine for 2 months~Fluoxetine: Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine."
11173213|NCT02014376|EG002|Reported Event|Vehicle (0%)|Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
11173214|NCT02014402|BG000|Baseline|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11173215|NCT02014402|BG001|Baseline|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
10910318|NCT00611975|BG001|Baseline|Bupropion|"Participants will receive treatment with bupropion for 2 months~Bupropion: Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion."
10910319|NCT00611975|BG002|Baseline|Total|Total of all reporting groups
10910320|NCT00611975|FG000|Participant Flow|Fluoxetine|"Participants will receive treatment with fluoxetine for 2 months~Fluoxetine: Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine."
10910321|NCT00611975|FG001|Participant Flow|Bupropion|"Participants will receive treatment with bupropion for 2 months~Bupropion: Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion."
10910322|NCT00611975|OG000|Outcome|Fluoxetine|"Participants will receive treatment with fluoxetine for 2 months~Fluoxetine: Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine."
10910323|NCT00611975|OG001|Outcome|Bupropion|"Participants will receive treatment with bupropion for 2 months~Bupropion: Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion."
11173216|NCT02014402|BG002|Baseline|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11173217|NCT02014402|BG003|Baseline|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
10910324|NCT00611975|EG000|Reported Event|Fluoxetine|"Participants will receive treatment with fluoxetine for 2 months~Fluoxetine: Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine."
10910325|NCT00611975|EG001|Reported Event|Bupropion|"Participants will receive treatment with bupropion for 2 months~Bupropion: Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion."
10910326|NCT00612040|BG000|Baseline|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910327|NCT00612040|BG001|Baseline|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910328|NCT00612040|BG002|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910329|NCT00612040|BG003|Baseline|Total|Total of all reporting groups
10910330|NCT00612040|FG000|Participant Flow|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910331|NCT00612040|FG001|Participant Flow|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910332|NCT00612040|FG002|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910333|NCT00612040|OG000|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910334|NCT00612040|OG001|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910335|NCT00612040|OG002|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910336|NCT00612040|EG000|Reported Event|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910337|NCT00612040|EG001|Reported Event|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910338|NCT00612040|EG002|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
10910339|NCT00612066|BG000|Baseline|Rosiglitazone|Rosiglitazone maleate :
10910340|NCT00612066|FG000|Participant Flow|Rosiglitazone|Rosiglitazone maleate :
10910341|NCT00612066|OG000|Outcome|Rosiglitazone|Rosiglitazone maleate :
10910342|NCT00612066|EG000|Reported Event|Rosiglitazone|Rosiglitazone maleate :
10910343|NCT00612105|BG000|Baseline|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
10910344|NCT00612105|BG001|Baseline|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
10910345|NCT00612105|BG002|Baseline|Total|Total of all reporting groups
11091230|NCT01533922|EG001|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091231|NCT01533922|EG002|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11173218|NCT02014402|BG004|Baseline|Total|Total of all reporting groups
10910346|NCT00612105|FG000|Participant Flow|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
10910347|NCT00612105|FG001|Participant Flow|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
10910348|NCT00612105|OG000|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
10910349|NCT00612105|OG001|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
10910350|NCT00612105|EG000|Reported Event|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
10910351|NCT00612105|EG001|Reported Event|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
10910352|NCT00612222|BG000|Baseline|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
10910353|NCT00612222|FG000|Participant Flow|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
10910354|NCT00612222|OG000|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
10910355|NCT00612222|EG000|Reported Event|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
10910356|NCT00612235|BG000|Baseline|1 Lamotrigine Monotherapy|Women with Epilepsy on Lamotrigine Monotherapy
10910357|NCT00612235|BG001|Baseline|2 Levetiracetam Monotherapy|Women with Epilepsy on Levetiracetam Monotherapy
10910358|NCT00612235|BG002|Baseline|3 Carbamazepine Monotherapy|Women with Epilepsy on Carbamazepine Monotherapy
10910359|NCT00612235|BG003|Baseline|5 Normal Control|Normal Control Women(no epilepsy)
10910360|NCT00612235|BG004|Baseline|Total|Total of all reporting groups
10910361|NCT00612235|FG000|Participant Flow|1 Lamotrigine Monotherapy|Women with Epilepsy on Lamotrigine Monotherapy
10910362|NCT00612235|FG001|Participant Flow|2 Levetiracetam Monotherapy|Women with Epilepsy on Levetiracetam Monotherapy
10910363|NCT00612235|FG002|Participant Flow|3 Carbamazepine Monotherapy|Women with Epilepsy on Carbamazepine Monotherapy
10910364|NCT00612235|FG003|Participant Flow|5 Normal Control|Normal Control Women(no epilepsy)
10910365|NCT00612235|OG000|Outcome|3 Carbamazepine Monotherapy|Women with Epilepsy on Carbamazepine Monotherapy
10910366|NCT00612235|OG001|Outcome|2 Levetiracetam Monotherapy|Women with Epilepsy on Levetiracetam Monotherapy
10910367|NCT00612235|OG002|Outcome|1 Lamotrigine Monotherapy|Women with Epilepsy on Lamotrigine Monotherapy
10910368|NCT00612235|OG000|Outcome|Women With Epilepsy|Women with Epilepsy
10910369|NCT00612235|OG001|Outcome|Control Group|Women without Epilepsy
10910370|NCT00612235|EG000|Reported Event|Lamotrigine|Women with Epilepsy on Lamotrigine Monotherapy
10910371|NCT00612235|EG001|Reported Event|Levetiracetam|Women with Epilepsy on Levetiracetam Monotherapy
10910372|NCT00612235|EG002|Reported Event|Carbamazepine|Women with Epilepsy on Carbamazepine Monotherapy
10910373|NCT00612235|EG003|Reported Event|Control|Normal control (no epilepsy)
10910374|NCT00612313|BG000|Baseline|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
10910375|NCT00612313|BG001|Baseline|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants attended 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
10910376|NCT00612313|BG002|Baseline|Total|Total of all reporting groups
10910377|NCT00612313|FG000|Participant Flow|Continued Medication Alone|"n=69 Participants will receive antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
10910378|NCT00612313|FG001|Participant Flow|Continued Medication Plus CBT|"n=75 Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
10910379|NCT00612313|OG000|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
10910380|NCT00612313|OG001|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
10910381|NCT00612313|OG000|Outcome|Continued Medication Alone|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
10910382|NCT00612313|OG001|Outcome|Continued Medication Plus CBT|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
10910383|NCT00612313|OG000|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~n=69"
10910384|NCT00612313|OG001|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~n=75"
10910385|NCT00612313|OG000|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Treatment was uncontrolled after week 30."
10910386|NCT00612313|OG001|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~Treatment was uncontrolled after week 30."
10910387|NCT00612313|EG000|Reported Event|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~N=69"
10910388|NCT00612313|EG001|Reported Event|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~N=75"
10910389|NCT00612339|BG000|Baseline|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
10910390|NCT00612339|FG000|Participant Flow|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
10910391|NCT00612339|OG000|Outcome|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
10910392|NCT00612339|EG000|Reported Event|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
10910393|NCT00612352|BG000|Baseline|Family History Positive|Subjects with a positive family history of alcoholism.
10910394|NCT00612352|BG001|Baseline|Family History Negative|Subjects with no family history of alcoholism.
10910395|NCT00612352|BG002|Baseline|Total|Total of all reporting groups
10910396|NCT00612352|FG000|Participant Flow|Family History Positive|Subjects with a positive family history of alcoholism.
10910397|NCT00612352|FG001|Participant Flow|Family History Negative|Subjects with no family history of alcoholism.
10910398|NCT00612352|OG000|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
10910399|NCT00612352|OG001|Outcome|Family History Negative|Subjects with no family history of alcoholism.
10910400|NCT00612352|EG000|Reported Event|Family History Positive|Subjects with a positive family history of alcoholism.
10910401|NCT00612352|EG001|Reported Event|Family History Negative|Subjects with no family history of alcoholism.
10910402|NCT00612430|BG000|Baseline|Grade III|
10910403|NCT00612430|BG001|Baseline|Grade IV|
10910404|NCT00612430|BG002|Baseline|Total|Total of all reporting groups
10910405|NCT00612430|FG000|Participant Flow|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
10910406|NCT00612430|FG001|Participant Flow|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
10910407|NCT00612430|OG000|Outcome|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
10910408|NCT00612430|OG001|Outcome|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
10910409|NCT00612430|OG000|Outcome|Grade III|
10910410|NCT00612430|OG001|Outcome|Grade IV|
10910411|NCT00612430|EG000|Reported Event|Grade III|
10910412|NCT00612430|EG001|Reported Event|Grade IV|
10910413|NCT00612456|BG000|Baseline|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses..
10910414|NCT00612456|BG001|Baseline|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910415|NCT00612456|BG002|Baseline|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910416|NCT00612456|BG003|Baseline|Total|Total of all reporting groups
10910417|NCT00612456|FG000|Participant Flow|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 milligrams per milliliter (mg/mL) three time daily (TID) for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910418|NCT00612456|FG001|Participant Flow|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910419|NCT00612456|FG002|Participant Flow|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910420|NCT00612456|OG000|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910421|NCT00612456|OG001|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910422|NCT00612456|OG002|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910423|NCT00612456|OG000|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops approximately with a 6-hour interval between daily doses.
10910424|NCT00612456|OG001|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops approximately with a 6-hour interval between daily doses.
10910425|NCT00612456|EG000|Reported Event|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910426|NCT00612456|EG001|Reported Event|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910427|NCT00612456|EG002|Reported Event|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
10910428|NCT00612508|BG000|Baseline|Desogen|oral contraceptive
10910429|NCT00612508|BG001|Baseline|NuvaRing|intravaginal contraception
10910430|NCT00612508|BG002|Baseline|Total|Total of all reporting groups
10910431|NCT00612508|FG000|Participant Flow|Desogen|oral contraceptive
10910432|NCT00612508|FG001|Participant Flow|NuvaRing|intravaginal contraception
10910433|NCT00612508|OG000|Outcome|Desogen|oral contraceptive = P (pill)
10910434|NCT00612508|OG001|Outcome|NuvaRing|intravaginal contraception = R (ring)
10910435|NCT00612508|OG000|Outcome|Oral Contraceptive|Desogen (ethinyl estradiol & desogestrel) = P (pill)
10910436|NCT00612508|OG001|Outcome|Intravaginal Ring Contraceptive|nuvaring (ethinyl estradiol & desogestrel) = R (ring)
10910437|NCT00612508|EG000|Reported Event|Desogen|oral contraceptive
10910438|NCT00612508|EG001|Reported Event|NuvaRing|intravaginal contraception
10910439|NCT00612534|BG000|Baseline|Sufentanil NanoTab 5 Mcg|
10910440|NCT00612534|BG001|Baseline|Sufentanil NanoTab 10 Mcg|
10910441|NCT00612534|BG002|Baseline|Sufentanil NanoTab 15 Mcg|
10910442|NCT00612534|BG003|Baseline|Placebo NanoTab|
10910443|NCT00612534|BG004|Baseline|Total|Total of all reporting groups
10910444|NCT00612534|FG000|Participant Flow|Sufentanil NanoTab 5 Mcg|
10910445|NCT00612534|FG001|Participant Flow|Sufentanil NanoTab 10 Mcg|
10910446|NCT00612534|FG002|Participant Flow|Sufentanil NanoTab 15 Mcg|
10910447|NCT00612534|FG003|Participant Flow|Placebo NanoTab|
10910448|NCT00612534|OG000|Outcome|Sufentanil NanoTab 5 Mcg|
10910449|NCT00612534|OG001|Outcome|Sufentanil NanoTab 10 Mcg|
10910450|NCT00612534|OG002|Outcome|Sufentanil NanoTab 15 Mcg|
10910451|NCT00612534|OG003|Outcome|Placebo NanoTab|
10910452|NCT00612534|EG000|Reported Event|Sufentanil NanoTab 5 Mcg|
10910453|NCT00612534|EG001|Reported Event|Sufentanil NanoTab 10 Mcg|
10910454|NCT00612534|EG002|Reported Event|Sufentanil NanoTab 15 Mcg|
10910455|NCT00612534|EG003|Reported Event|Placebo NanoTab|
10910456|NCT00612560|BG000|Baseline|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
10910457|NCT00612560|BG001|Baseline|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
10910458|NCT00612560|BG002|Baseline|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
10910459|NCT00612560|BG003|Baseline|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
10910460|NCT00612560|BG004|Baseline|Total|Total of all reporting groups
10910461|NCT00612560|FG000|Participant Flow|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
10910462|NCT00612560|FG001|Participant Flow|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
10910463|NCT00612560|FG002|Participant Flow|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
10910464|NCT00612560|FG003|Participant Flow|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
10910465|NCT00612560|OG000|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
10910466|NCT00612560|OG001|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
10910467|NCT00612560|OG002|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
10910468|NCT00612560|OG003|Outcome|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
10910469|NCT00612560|EG000|Reported Event|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
10910470|NCT00612560|EG001|Reported Event|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
10910471|NCT00612560|EG002|Reported Event|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
10910472|NCT00612560|EG003|Reported Event|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
10910473|NCT00612573|BG000|Baseline|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
10910474|NCT00612573|BG001|Baseline|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
10910475|NCT00612573|BG002|Baseline|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
10910476|NCT00612573|BG003|Baseline|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
10910477|NCT00612573|BG004|Baseline|Total|Total of all reporting groups
10910478|NCT00612573|FG000|Participant Flow|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
10910479|NCT00612573|FG001|Participant Flow|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
10910480|NCT00612573|FG002|Participant Flow|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
10910481|NCT00612573|FG003|Participant Flow|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
10910482|NCT00612573|OG000|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
10910483|NCT00612573|OG001|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
10910484|NCT00612573|OG002|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
10910485|NCT00612573|OG003|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
10910486|NCT00612573|EG000|Reported Event|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
10910487|NCT00612573|EG001|Reported Event|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
10910488|NCT00612573|EG002|Reported Event|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
10910489|NCT00612573|EG003|Reported Event|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
10910490|NCT00612586|BG000|Baseline|Enzastaurin + 5-FU/LV + Bev|"Enzastaurin: Loading dose of 1125 mg orally, 3 times during Day 1 of Cycle 1 (14-day cycle); 500 mg orally, twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~LV: 400 mg/m^2 IV on Day 1 of each 14-day cycle, followed by 5-FU 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bev: 5 mg/kg IV.~First-line therapy for metastatic CRC received prior to entering the study: six 14-day cycles (12 weeks) folinic acid, 5-FU, and oxaliplatin (FOLFOX) or folinic acid, 5-FU, and irinotecan (FOLFIRI), plus Bev."
10910491|NCT00612586|BG001|Baseline|Placebo + 5-FU/LV + Bev|"Placebo: administered orally 3 times during Day 1 of Cycle 1 (14 day cycle); placebo administered orally twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~Leucovorin (LV): 400 mg/m^2 administered by IV on Day 1 of each 14 day cycle, followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bevacizumab (Bev): 5 milligrams/kilogram (mg/kg) IV.~First-line therapy for CRC received prior to entering the study: six 14-day cycles (12 weeks) folinic acid, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) or folinic acid, 5-FU, and irinotecan (FOLFIRI), plus Bev."
10910492|NCT00612586|BG002|Baseline|Total|Total of all reporting groups
11091232|NCT01533922|EG003|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10910493|NCT00612586|FG000|Participant Flow|Enzastaurin + 5-FU/LV + Bev|"Enzastaurin: Loading dose of 1125 milligrams (mg) orally, 3 times during Day 1 of Cycle 1 (14-day cycle); 500 mg orally, twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~Leucovorin (LV): 400 mg per meter squared (mg/m^2) intravenously (IV) on Day 1 of each 14-day cycle, followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bevacizumab (Bev): 5 milligrams/kilogram (mg/kg) IV.~First-line therapy for metastatic colorectal cancer (CRC) received prior to entering the study: six 14-day cycles (12 weeks) folinic acid, 5-FU, and oxaliplatin (FOLFOX) or folinic acid, 5-FU, and irinotecan (FOLFIRI), plus Bev."
10910494|NCT00612586|FG001|Participant Flow|Placebo + 5-FU/LV + Bev|"Placebo: Orally 3 times during Day 1 of Cycle 1 (14-day cycle); orally, twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~LV: 400 mg/m^2 IV on Day 1 of each 14-day cycle, followed by 5-FU 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bev: 5 mg/kg IV.~First-line therapy for CRC received prior to entering the study: six 14-day cycles (12 weeks) FOLFOX or FOLFIRI, plus Bev."
10910495|NCT00612586|OG000|Outcome|Enzastaurin + 5-FU/LV + Bev|"Enzastaurin: Loading dose of 1125 mg orally, 3 times during Day 1 of Cycle 1 (14-day cycle); 500 mg orally, twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~LV: 400 mg/m^2 IV on Day 1 of each 14-day cycle, followed by 5-FU 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bev: 5 mg/kg IV.~First-line therapy for metastatic CRC received prior to entering the study: six 14-day cycles (12 weeks) folinic acid, 5-FU, and oxaliplatin (FOLFOX) or folinic acid, 5-FU, and irinotecan (FOLFIRI), plus Bev."
10910496|NCT00612586|OG001|Outcome|Placebo + 5FU/LV + Bev|"Placebo: Orally 3 times during Day 1 of Cycle 1 (14-day cycle); orally, twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~LV: 400 mg/m^2 IV on Day 1 of each 14-day cycle, followed by 5-FU 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bev: 5 mg/kg IV.~First-line therapy for CRC received prior to entering the study: six 14-day cycles (12 weeks) FOLFOX or FOLFIRI, plus Bev."
10910497|NCT00612586|OG001|Outcome|Placebo + 5FU/LV +Bev|"Placebo: Orally 3 times during Day 1 of Cycle 1 (14-day cycle); orally, twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~LV: 400 mg/m^2 IV on Day 1 of each 14-day cycle, followed by 5-FU 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bev: 5 mg/kg IV.~First-line therapy for CRC received prior to entering the study: six 14-day cycles (12 weeks) FOLFOX or FOLFIRI, plus Bev."
10910498|NCT00612586|EG000|Reported Event|Enzastaurin + 5-FU/LV Plus Bevacizumab|"Enzastaurin: loading dose of 1125 mg administered orally 3 times during Day 1 of Cycle 1 (14 day cycle); 500 mg administered orally twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~Leucovorin (LV): 400 mg per meter squared (mg/m^2) administered by IV on Day 1 of each 14 day cycle, followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bevacizumab (Bev): 5 milligrams/kilogram (mg/kg) IV.~First-line therapy for CRC received prior to entering the study: six 14-day cycles (12 weeks) folinic acid, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) or folinic acid, 5-FU, and irinotecan (FOLFIRI), plus Bev."
10910499|NCT00612586|EG001|Reported Event|Placebo + 5FU/LV + Bevacizumab|"Placebo: administered orally 3 times during Day 1 of Cycle 1 (14 day cycle); placebo administered orally twice daily on Day 2 to Day 14 of Cycle 1 and all subsequent cycles.~Leucovorin (LV): 400 mg/m^2 administered by IV on Day 1 of each 14 day cycle, followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus then 2400 mg/m^2 IV over 46 hours, plus Bevacizumab (Bev): 5 milligrams/kilogram (mg/kg) IV.~First-line therapy for CRC received prior to entering the study: six 14-day cycles (12 weeks) folinic acid, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) or folinic acid, 5-FU, and irinotecan (FOLFIRI), plus Bev."
10910500|NCT00612690|BG000|Baseline|Links to Learning|Mental health intervention focused on enhancing the predictors of young children's school success
10910501|NCT00612690|BG001|Baseline|Services As Usual|Referral to nearby community mental heath agencies for clinic-based services where participants received standard care for mental health-related problems.
10910502|NCT00612690|BG002|Baseline|Total|Total of all reporting groups
10910503|NCT00612690|FG000|Participant Flow|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
10910504|NCT00612690|FG001|Participant Flow|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
10910505|NCT00612690|OG000|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
10910506|NCT00612690|OG001|Outcome|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services where participants received standard care for mental health-related problems."
11342179|NCT03700372|FG000|Participant Flow|IOWA Approach Cardiac Ablation|"Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation.~IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System"
10910507|NCT00612690|OG000|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
10910508|NCT00612690|OG001|Outcome|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
10910509|NCT00612690|EG000|Reported Event|Links to Learning|"Participants will undergo the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program includes collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
10910510|NCT00612690|EG001|Reported Event|Services as Usual|"Participants will receive treatment as usual and referrals.~Treatment as usual (TAU) : TAU includes referral to community mental health clinic-based services, where participants will receive standard care for mental health-related problems."
10910511|NCT00612716|BG000|Baseline|Allogeneic Transplantation|Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
10910512|NCT00612716|FG000|Participant Flow|Allogeneic Transplantation|Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
10910513|NCT00612716|OG000|Outcome|Allogeneic Transplantation|Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
10910514|NCT00612716|EG000|Reported Event|Allogeneic Transplantation|Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
10910515|NCT00612768|BG000|Baseline|Sensitive Subjects|Subjects with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.
10910516|NCT00612768|FG000|Participant Flow|Sensitive Subjects|All subjects recruited to this study were to have had previous positive patch test results to one of the allergens tested on the study.
10910517|NCT00612768|OG000|Outcome|Fragrance Mix|Percent agreement between T.R.U.E. Test allergen in PVP vs HPC
10910518|NCT00612768|OG001|Outcome|Thimerosol|Percent agreement between T.R.U.E. Test allergen in PVP vs HPC
10910519|NCT00612768|OG000|Outcome|Sensitivity: Fragrance Mix in HPC|Agreement between positive results for the test and reference allergen
10910520|NCT00612768|OG001|Outcome|Sensitivity: Fragrance Mix in PVP|Agreement between positive results for the test and reference allergen
10910521|NCT00612768|OG002|Outcome|Sensitivity: Thimerosal in HPC|Agreement between positive results for the test and reference allergen
10910522|NCT00612768|OG003|Outcome|Sensitivity: Thimerosol in PVP|Agreement between positive results for the test and reference allergen
10910523|NCT00612768|OG004|Outcome|Specificity: Fragrance Mix in HPC|Agreement between negative results for the test and reference allergen
10910524|NCT00612768|OG005|Outcome|Specificity: Fragrance Mix in PVP|Agreement between negative results for the test and reference allergen
10910525|NCT00612768|OG006|Outcome|Specificity: Thimerosal in HPC|Agreement between negative results for the test and reference allergen
10910526|NCT00612768|OG007|Outcome|Specificity: Thimerosal in PVP|Agreement between negative results for the test and reference allergen
10910527|NCT00612768|OG000|Outcome|Tape Irritation: TRUE Test Panel|Percentage of participants who exhibited tape-induced irritation at visit 2.
10910528|NCT00612768|OG001|Outcome|Incomplete Panel Adhesion: TRUE Test|Percentage of participants whose panels were not 100% adhered at visit 2.
10910529|NCT00612768|OG002|Outcome|Incomplete Panel Adhesion: Reference Allergen|Percentage of participants whose panels were not 100% adhered at visit 2.
10910530|NCT00612768|OG003|Outcome|Itching and Burning|Percentage of participants who reported patch related itching and/or burning at visit 2
10910531|NCT00612768|OG000|Outcome|Late Reactions: Fragrance Mix in HPC|Late reactions occur 7-10 days after patch application
10910532|NCT00612768|OG001|Outcome|Late Reactions: Fragrance Mix in PVP|Late reactions occur 7-10 days after patch application
10910533|NCT00612768|OG002|Outcome|Late Reactions: Thimerosal in HPC|Late reactions occur 7-10 days after patch application
10910534|NCT00612768|OG003|Outcome|Late Reactions: Thimerosol in PVP|Late reactions occur 7-10 days after patch application
10910535|NCT00612768|OG004|Outcome|Persistent Reactions: Fragrance Mix in HPC|Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
10910536|NCT00612768|OG005|Outcome|Persistent Reactions: Fragrance Mix in PVP|Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
10910537|NCT00612768|OG006|Outcome|Persistent Reactions: Thimerosal in HPC|Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
10910538|NCT00612768|OG007|Outcome|Persistent Reactions: Thimerosal in PVP|Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
10910539|NCT00612768|EG000|Reported Event|Sensitives|subjects per allergen with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.
10910540|NCT00612807|BG000|Baseline|Semi-weekly Medication Management|Medication management with a study doctor every other week.
10910541|NCT00612807|BG001|Baseline|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
10910542|NCT00612807|BG002|Baseline|Total|Total of all reporting groups
10910543|NCT00612807|FG000|Participant Flow|Semi-weekly Medication Management|Medication management with a study doctor every other week.
10910544|NCT00612807|FG001|Participant Flow|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
10910545|NCT00612807|OG000|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
10910546|NCT00612807|OG001|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
10910547|NCT00612807|EG000|Reported Event|Semi-weekly Medication Management|Medication management with a study doctor every other week.
10910548|NCT00612807|EG001|Reported Event|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
10910549|NCT00612924|BG000|Baseline|Anaconda|The original protocol identified that the Anaconda™ Stent Graft System would be used throughout the current Phase II study. However, a modified device design became available during the course of the current Phase II study and is called the ONELOK™ Stent Graft System. As the modifications to the device design are considered minor, there are no expected differences in the anticipated safety or effectiveness of the device. The design changes relate primary to a uni-docking zone in the bifurcate body to maximize sizing compatibilities between the bifurcate body and the iliac limbs.
10910550|NCT00612924|BG001|Baseline|ONE-LOK|
10910551|NCT00612924|BG002|Baseline|Total|Total of all reporting groups
10910552|NCT00612924|FG000|Participant Flow|Anaconda|
10910553|NCT00612924|FG001|Participant Flow|ONE-LOK|
10910554|NCT00612924|OG000|Outcome|Anaconda|
10910555|NCT00612924|OG001|Outcome|ONE LOK|
10910556|NCT00612924|OG002|Outcome|Total|
10910557|NCT00612924|EG000|Reported Event|Anaconda|
10910558|NCT00612924|EG001|Reported Event|ONE-LOK|
10910559|NCT00613015|BG000|Baseline|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
10910560|NCT00613015|BG001|Baseline|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
10910561|NCT00613015|BG002|Baseline|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
10910562|NCT00613015|BG003|Baseline|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
10910563|NCT00613015|BG004|Baseline|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
10910564|NCT00613015|BG005|Baseline|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
10910565|NCT00613015|BG006|Baseline|Total|Total of all reporting groups
10910566|NCT00613015|FG000|Participant Flow|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
10910567|NCT00613015|FG001|Participant Flow|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
10910568|NCT00613015|FG002|Participant Flow|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
10910569|NCT00613015|FG003|Participant Flow|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
10910570|NCT00613015|FG004|Participant Flow|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
10910571|NCT00613015|FG005|Participant Flow|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
10910572|NCT00613015|OG000|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
10910573|NCT00613015|OG001|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
10910574|NCT00613015|OG002|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
10910575|NCT00613015|OG003|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
10910576|NCT00613015|OG004|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
10910577|NCT00613015|OG005|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
10910578|NCT00613015|EG000|Reported Event|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
10910579|NCT00613015|EG001|Reported Event|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
10910580|NCT00613015|EG002|Reported Event|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
10910581|NCT00613015|EG003|Reported Event|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
10910582|NCT00613015|EG004|Reported Event|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
10910583|NCT00613015|EG005|Reported Event|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
10910584|NCT00613028|BG000|Baseline|Temozolomide Arm|Pts treated w Bev + Temozolomide
10910585|NCT00613028|BG001|Baseline|Etoposide Arm|Pts treated w Bev + Etoposide
10910586|NCT00613028|BG002|Baseline|Total|Total of all reporting groups
10910587|NCT00613028|FG000|Participant Flow|Temozolomide Arm|Bevacizumab + Temozolomide: Patients who progressed or had grade 3 or greater toxicity related to prior daily etoposide dosing, but have not had prior progression or grade 3 toxicity related to prior daily temozolomide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Temozolomide will be administered ona continuous daily dosing schedule at 50 mg/m^2/day.
10910588|NCT00613028|FG001|Participant Flow|Etoposide Arm|Bevacizumab + Etoposide: Patients who progressed or had grade 3 or greater toxicity related to prior daily temozolomide dosing, but have not had prior progression or grade 3 or greater toxicity related to prior daily etoposide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Etoposide will be administered once daily at 50 mg/m^2/day for the first 21 days of each 28-day cycle.
10910589|NCT00613028|OG000|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
10910590|NCT00613028|OG001|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
10910591|NCT00613028|EG000|Reported Event|Temozolomide Arm|Pts treated w Bev + Temozolomide
10910592|NCT00613028|EG001|Reported Event|Etoposide Arm|Pts treated w Bev + Etoposide
10910593|NCT00613080|BG000|Baseline|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
10910594|NCT00613080|FG000|Participant Flow|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
10910595|NCT00613080|OG000|Outcome|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
10910596|NCT00613080|EG000|Reported Event|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
10910597|NCT00613106|BG000|Baseline|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
10910598|NCT00613106|BG001|Baseline|Ibuprofen|Ibuprofen 800mg
10910599|NCT00613106|BG002|Baseline|Total|Total of all reporting groups
10910600|NCT00613106|FG000|Participant Flow|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
10910601|NCT00613106|FG001|Participant Flow|Ibuprofen|Ibuprofen 800mg
10910602|NCT00613106|OG000|Outcome|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
10910603|NCT00613106|OG001|Outcome|Ibuprofen|Ibuprofen 800mg
10910604|NCT00613106|EG000|Reported Event|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
10910605|NCT00613106|EG001|Reported Event|Ibuprofen|Ibuprofen 800mg
10910606|NCT00613171|BG000|Baseline|STI571|Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
10910607|NCT00613171|FG000|Participant Flow|STI571|Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
10910608|NCT00613171|OG000|Outcome|STI571|Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
10910609|NCT00613171|OG000|Outcome|STI571|Participants received STI571 100 mg tablets, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week24, if well tolerated.
10910610|NCT00613171|EG000|Reported Event|ST1571|Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
10910611|NCT00613301|BG000|Baseline|Pramipexole|The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations.
10910612|NCT00613301|FG000|Participant Flow|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
10910613|NCT00613301|OG000|Outcome|Pramipexole|Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
10910614|NCT00613301|OG000|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
10910615|NCT00613301|EG000|Reported Event|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
10910616|NCT00613314|BG000|Baseline|Telmisartan (Micardis)|
10910617|NCT00613314|FG000|Participant Flow|Telmisartan (Micardis)|
10910618|NCT00613314|OG000|Outcome|Telmisartan (Micardis)|
10910619|NCT00613314|EG000|Reported Event|Telmisartan (Micardis)|
10910620|NCT00613327|BG000|Baseline|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
10910621|NCT00613327|FG000|Participant Flow|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
10910622|NCT00613327|OG000|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
10910623|NCT00613327|EG000|Reported Event|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
10910624|NCT00613366|BG000|Baseline|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
10910625|NCT00613366|BG001|Baseline|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
10910626|NCT00613366|BG002|Baseline|Total|Total of all reporting groups
10910627|NCT00613366|FG000|Participant Flow|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
10910628|NCT00613366|FG001|Participant Flow|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
10910629|NCT00613366|OG000|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
10910630|NCT00613366|OG001|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
10910631|NCT00613366|EG000|Reported Event|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
10910632|NCT00613366|EG001|Reported Event|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
10910633|NCT00613379|BG000|Baseline|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
10910634|NCT00613379|BG001|Baseline|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
10910635|NCT00613379|BG002|Baseline|Arm 3|PBO, one IV dose (N=10)
10910636|NCT00613379|BG003|Baseline|Total|Total of all reporting groups
10910637|NCT00613379|FG000|Participant Flow|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
10910638|NCT00613379|FG001|Participant Flow|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
10910639|NCT00613379|FG002|Participant Flow|Arm 3|PBO, one IV dose (N=10)
10910640|NCT00613379|OG000|Outcome|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
10910641|NCT00613379|OG001|Outcome|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
10910642|NCT00613379|OG002|Outcome|Arm 3|PBO, one IV dose (N=10)
10910643|NCT00613379|EG000|Reported Event|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
10910644|NCT00613379|EG001|Reported Event|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
10910645|NCT00613379|EG002|Reported Event|Arm 3|PBO, one IV dose (N=10)
10910646|NCT00613405|BG000|Baseline|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
10910647|NCT00613405|BG001|Baseline|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
10910648|NCT00613405|BG002|Baseline|Total|Total of all reporting groups
10910649|NCT00613405|FG000|Participant Flow|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
10910650|NCT00613405|FG001|Participant Flow|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
10910651|NCT00613405|OG000|Outcome|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
10910652|NCT00613405|OG001|Outcome|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
10910653|NCT00613405|EG000|Reported Event|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
10910654|NCT00613405|EG001|Reported Event|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
10910655|NCT00613509|BG000|Baseline|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
10910656|NCT00613509|BG001|Baseline|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
10910657|NCT00613509|BG002|Baseline|Total|Total of all reporting groups
10910658|NCT00613509|FG000|Participant Flow|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
10910659|NCT00613509|FG001|Participant Flow|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
10910660|NCT00613509|OG000|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
10910661|NCT00613509|OG001|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
10910662|NCT00613509|EG000|Reported Event|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
10910663|NCT00613509|EG001|Reported Event|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
10910664|NCT00613574|BG000|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
10910665|NCT00613574|FG000|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
10910666|NCT00613574|OG000|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
10910667|NCT00613574|EG000|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
10910668|NCT00613626|BG000|Baseline|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
10910669|NCT00613626|BG001|Baseline|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
10910670|NCT00613626|BG002|Baseline|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
10910671|NCT00613626|BG003|Baseline|Total|Total of all reporting groups
10910672|NCT00613626|FG000|Participant Flow|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
10910673|NCT00613626|FG001|Participant Flow|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
10910674|NCT00613626|FG002|Participant Flow|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
10910675|NCT00613626|OG000|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
11342180|NCT03700372|OG000|Outcome|IOWA Approach Cardiac Ablation|"Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation.~IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System"
10910676|NCT00613626|OG001|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
10910677|NCT00613626|OG001|Outcome|Arm B: ZD6474 + Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
10910678|NCT00613626|EG000|Reported Event|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
10910679|NCT00613626|EG001|Reported Event|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
10910680|NCT00613821|BG000|Baseline|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.~Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
10910681|NCT00613821|BG001|Baseline|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.~Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
10910682|NCT00613821|BG002|Baseline|Total|Total of all reporting groups
10910683|NCT00613821|FG000|Participant Flow|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.~Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
10910684|NCT00613821|FG001|Participant Flow|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.~Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
11173219|NCT02014402|FG000|Participant Flow|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11173220|NCT02014402|FG001|Participant Flow|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
10910685|NCT00613821|OG000|Outcome|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.~Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
10910686|NCT00613821|OG001|Outcome|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.~Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
10910687|NCT00613821|EG000|Reported Event|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.~Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
10910688|NCT00613821|EG001|Reported Event|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.~Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
10910689|NCT00613834|BG000|Baseline|Lidocaine Group|Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization
10910690|NCT00613834|BG001|Baseline|Saline Group|Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
10910691|NCT00613834|BG002|Baseline|Total|Total of all reporting groups
10910692|NCT00613834|FG000|Participant Flow|Lidocaine Group|Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization
10910693|NCT00613834|FG001|Participant Flow|Saline Group|Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
10910694|NCT00613834|OG000|Outcome|Lidocaine Group|Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization
10910695|NCT00613834|OG001|Outcome|Saline Group|Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
10910696|NCT00613834|OG000|Outcome|Lidocaine Group|"Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization~Lidocaine: 5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes"
10910697|NCT00613834|OG001|Outcome|Control Group|"Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization~Sterile Saline: 5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes"
10910698|NCT00613834|EG000|Reported Event|Lidocaine Group|Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization
10910699|NCT00613834|EG001|Reported Event|Saline Group|Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
10910700|NCT00613925|BG000|Baseline|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
10910701|NCT00613925|BG001|Baseline|Explora Group|Women were randomized to the Explora device for endometrial biopsy
10910702|NCT00613925|BG002|Baseline|Total|Total of all reporting groups
10910703|NCT00613925|FG000|Participant Flow|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
10910704|NCT00613925|FG001|Participant Flow|Explora Group|Women were randomized to the Explora device for endometrial biopsy
10910705|NCT00613925|OG000|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
10910706|NCT00613925|OG001|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
10910707|NCT00613925|EG000|Reported Event|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
10910708|NCT00613925|EG001|Reported Event|Explora Group|Women were randomized to the Explora device for endometrial biopsy
10910709|NCT00613938|BG000|Baseline|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
11091233|NCT01533922|EG004|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10910710|NCT00613938|BG001|Baseline|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910711|NCT00613938|BG002|Baseline|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910712|NCT00613938|BG003|Baseline|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910713|NCT00613938|BG004|Baseline|Total|Total of all reporting groups
10910714|NCT00613938|FG000|Participant Flow|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
10910715|NCT00613938|FG001|Participant Flow|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910716|NCT00613938|FG002|Participant Flow|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910717|NCT00613938|FG003|Participant Flow|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910718|NCT00613938|OG000|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
10910719|NCT00613938|OG001|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910720|NCT00613938|OG002|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910721|NCT00613938|OG003|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910722|NCT00613938|EG000|Reported Event|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
10910723|NCT00613938|EG001|Reported Event|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910724|NCT00613938|EG002|Reported Event|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910725|NCT00613938|EG003|Reported Event|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
10910726|NCT00613951|BG000|Baseline|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910727|NCT00613951|BG001|Baseline|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910728|NCT00613951|BG002|Baseline|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910729|NCT00613951|BG003|Baseline|Total|Total of all reporting groups
10910730|NCT00613951|FG000|Participant Flow|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910731|NCT00613951|FG001|Participant Flow|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910732|NCT00613951|FG002|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910733|NCT00613951|OG000|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910734|NCT00613951|OG001|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910735|NCT00613951|OG002|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910736|NCT00613951|OG000|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910737|NCT00613951|OG001|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910738|NCT00613951|OG002|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910739|NCT00613951|EG000|Reported Event|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910740|NCT00613951|EG001|Reported Event|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910741|NCT00613951|EG002|Reported Event|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910742|NCT00614055|BG000|Baseline|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910743|NCT00614055|BG001|Baseline|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910744|NCT00614055|BG002|Baseline|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910745|NCT00614055|BG003|Baseline|Total|Total of all reporting groups
10910746|NCT00614055|FG000|Participant Flow|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910747|NCT00614055|FG001|Participant Flow|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910748|NCT00614055|FG002|Participant Flow|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910749|NCT00614055|OG000|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910750|NCT00614055|OG001|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910751|NCT00614055|OG002|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910752|NCT00614055|OG000|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910753|NCT00614055|OG001|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910754|NCT00614055|OG002|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910755|NCT00614055|EG000|Reported Event|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910756|NCT00614055|EG001|Reported Event|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910757|NCT00614055|EG002|Reported Event|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
10910758|NCT00614120|BG000|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910759|NCT00614120|BG001|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910760|NCT00614120|BG002|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910761|NCT00614120|BG003|Baseline|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
10910762|NCT00614120|BG004|Baseline|Total|Total of all reporting groups
10910763|NCT00614120|FG000|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910764|NCT00614120|FG001|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910765|NCT00614120|FG002|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910766|NCT00614120|FG003|Participant Flow|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
10910767|NCT00614120|OG000|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910768|NCT00614120|OG001|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910769|NCT00614120|OG002|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910770|NCT00614120|OG003|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
10910771|NCT00614120|EG000|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910772|NCT00614120|EG001|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910773|NCT00614120|EG002|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
10910774|NCT00614120|EG003|Reported Event|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
10910775|NCT00614198|BG000|Baseline|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
10910776|NCT00614198|BG001|Baseline|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
10910777|NCT00614198|BG002|Baseline|Total|Total of all reporting groups
10910778|NCT00614198|FG000|Participant Flow|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
10910779|NCT00614198|FG001|Participant Flow|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
10910780|NCT00614198|OG000|Outcome|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
10910781|NCT00614198|OG001|Outcome|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
10910782|NCT00614198|EG000|Reported Event|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
10910783|NCT00614198|EG001|Reported Event|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
10910784|NCT00614315|BG000|Baseline|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
10910785|NCT00614315|FG000|Participant Flow|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
10910786|NCT00614315|OG000|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
10910787|NCT00614315|EG000|Reported Event|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
10910788|NCT00614380|BG000|Baseline|Telmisartan 40mg and Amlodipine 5mg|
10910789|NCT00614380|BG001|Baseline|Telmisartan 80mg and Amlodipine 5mg|
10910790|NCT00614380|BG002|Baseline|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
10910791|NCT00614380|BG003|Baseline|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
10910792|NCT00614380|BG004|Baseline|Total|Total of all reporting groups
10910793|NCT00614380|FG000|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
10910794|NCT00614380|FG001|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
10910795|NCT00614380|FG002|Participant Flow|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
10910796|NCT00614380|FG003|Participant Flow|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
10910797|NCT00614380|OG000|Outcome|Telmisartan 40mg and Amlodipine 5mg|
10910798|NCT00614380|OG001|Outcome|Telmisartan 80mg and Amlodipine 5mg|
10910799|NCT00614380|OG002|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
10910800|NCT00614380|OG003|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
10910801|NCT00614380|OG000|Outcome|Total|
10910802|NCT00614380|OG000|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
10910803|NCT00614380|OG001|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
10910804|NCT00614380|OG002|Outcome|Pre-antihypertensive: Total|
10910805|NCT00614380|OG000|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
10910806|NCT00614380|OG001|Outcome|Pre-titration: No (DBP>=90 mmHg)|
10910807|NCT00614380|OG002|Outcome|Pre-titration: Total|
10910808|NCT00614380|EG000|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
11173221|NCT02014402|FG002|Participant Flow|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11173222|NCT02014402|FG003|Participant Flow|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11173223|NCT02014402|OG000|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
10910809|NCT00614380|EG001|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
10910810|NCT00614393|BG000|Baseline|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
10910811|NCT00614393|BG001|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
10910812|NCT00614393|BG002|Baseline|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
10910813|NCT00614393|BG003|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
10910814|NCT00614393|BG004|Baseline|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
10910815|NCT00614393|BG005|Baseline|Total|Total of all reporting groups
10910816|NCT00614393|FG000|Participant Flow|Dalotuzumab 10 mg/kg Q1W (DB)|In double-blind (DB) Week 1, participants received cetuximab 400 mg/m^2 intravenously (IV) loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV one time each week (Q1W) maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
10910817|NCT00614393|FG001|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the open-label (OL) portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV one time every two weeks (Q2W) for up to 32 months of treatment.
10910818|NCT00614393|FG002|Participant Flow|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
11342181|NCT03700372|EG000|Reported Event|IOWA Approach Cardiac Ablation|"Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation.~IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System"
10910819|NCT00614393|FG003|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
10910820|NCT00614393|FG004|Participant Flow|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received a cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
10910821|NCT00614393|OG000|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
10910822|NCT00614393|OG001|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
10910823|NCT00614393|OG002|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
10910824|NCT00614393|OG003|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
10910825|NCT00614393|OG004|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
10910826|NCT00614393|EG000|Reported Event|Dalotuzumab 10 mg/kg Q1W (BD)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
10910827|NCT00614393|EG001|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
10910828|NCT00614393|EG002|Reported Event|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
10910829|NCT00614393|EG003|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
10910830|NCT00614393|EG004|Reported Event|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
10910831|NCT00614406|BG000|Baseline|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
10910832|NCT00614406|BG001|Baseline|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
10910833|NCT00614406|BG002|Baseline|Total|Total of all reporting groups
10910834|NCT00614406|FG000|Participant Flow|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
10910835|NCT00614406|FG001|Participant Flow|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
10910836|NCT00614406|OG000|Outcome|Active Drug|Active drug(celecoxib 400 mg orally, daily for 1 menstrual cycle) cycle [cycle = length of menstrual cycle]
10910837|NCT00614406|OG001|Outcome|Placebo|Placebo cycle orally, daily x1 menstrual cycle [cycle = length of menstrual cycle]
10910838|NCT00614406|EG000|Reported Event|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
10910839|NCT00614406|EG001|Reported Event|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
10910840|NCT00614432|BG000|Baseline|Women Who Are Anticoagulated|Women who are anticoagulated.
10910841|NCT00614432|BG001|Baseline|Matched Case Controls|Matched case controls.
10910842|NCT00614432|BG002|Baseline|Total|Total of all reporting groups
10910843|NCT00614432|FG000|Participant Flow|Women Who Are Anticoagulated Having Surgical Abortion Below 12|Women who are anticoagulated having surgical abortion below 12 weeks gestation
10910844|NCT00614432|FG001|Participant Flow|Women Who Are Not Anticoagulated Having Surgical Abortion Less|Women who are not anticoagulated having surgical abortion less than 12 weeks gestation
10910845|NCT00614432|OG000|Outcome|Women Who Are Anticoagulated|Women who are anticoagulated.
10910846|NCT00614432|OG001|Outcome|Matched Case Controls|Matched case controls.
10910847|NCT00614432|EG000|Reported Event|Women Who Are Anticoagulated|Women who are anticoagulated.
10910848|NCT00614432|EG001|Reported Event|Matched Case Controls|Matched case controls.
10910849|NCT00614445|BG000|Baseline|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
10910850|NCT00614445|BG001|Baseline|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
10910851|NCT00614445|BG002|Baseline|Total|Total of all reporting groups
10910852|NCT00614445|FG000|Participant Flow|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
10910853|NCT00614445|FG001|Participant Flow|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
10910854|NCT00614445|OG000|Outcome|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
10910855|NCT00614445|OG001|Outcome|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
10910856|NCT00614445|EG000|Reported Event|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
10910857|NCT00614445|EG001|Reported Event|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
10910858|NCT00614458|BG000|Baseline|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
10910859|NCT00614458|FG000|Participant Flow|Effect on Latent HIV of Adding Raltegravir and VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and Valproic acid (VPA) and current antiretroviral therapy (ART) on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
10910860|NCT00614458|OG000|Outcome|Effect on Latent HIV of Adding Raltegravir and VPA to ART|
10910861|NCT00614458|EG000|Reported Event|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
10910862|NCT00614484|BG000|Baseline|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
10910863|NCT00614484|FG000|Participant Flow|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
10910864|NCT00614484|OG000|Outcome|Chemothrapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
10910865|NCT00614484|OG000|Outcome|Chemotherapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
10910866|NCT00614484|EG000|Reported Event|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
10910867|NCT00614523|BG000|Baseline|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
10910868|NCT00614523|BG001|Baseline|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
10910869|NCT00614523|BG002|Baseline|Total|Total of all reporting groups
10910870|NCT00614523|FG000|Participant Flow|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
10910871|NCT00614523|FG001|Participant Flow|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
10910872|NCT00614523|OG000|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
10910873|NCT00614523|OG001|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
10910874|NCT00614523|EG000|Reported Event|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
10910875|NCT00614523|EG001|Reported Event|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
10910876|NCT00614575|BG000|Baseline|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
10910877|NCT00614575|FG000|Participant Flow|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
10910878|NCT00614575|OG000|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
10910879|NCT00614575|EG000|Reported Event|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
10910880|NCT00614614|BG000|Baseline|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
10910881|NCT00614614|BG001|Baseline|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
10910882|NCT00614614|BG002|Baseline|Total|Total of all reporting groups
10910883|NCT00614614|FG000|Participant Flow|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group].
11173224|NCT02014402|OG001|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11173225|NCT02014402|OG002|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11173226|NCT02014402|OG003|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11342182|NCT03700385|BG000|Baseline|IOWA Approach Endocardial Ablation|"Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation.~IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System"
10910884|NCT00614614|FG001|Participant Flow|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
10910885|NCT00614614|FG002|Participant Flow|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910886|NCT00614614|FG003|Participant Flow|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910887|NCT00614614|FG004|Participant Flow|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910888|NCT00614614|OG000|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
10910889|NCT00614614|OG001|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910890|NCT00614614|OG002|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910891|NCT00614614|OG003|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910892|NCT00614614|OG000|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
10910893|NCT00614614|OG001|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
10910894|NCT00614614|OG002|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
10910895|NCT00614614|OG003|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
10910896|NCT00614614|EG000|Reported Event|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
10910897|NCT00614614|EG001|Reported Event|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
10910898|NCT00614614|EG002|Reported Event|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910899|NCT00614614|EG003|Reported Event|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910900|NCT00614614|EG004|Reported Event|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
10910901|NCT00614744|BG000|Baseline|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
10910902|NCT00614744|BG001|Baseline|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
10910903|NCT00614744|BG002|Baseline|Total|Total of all reporting groups
10910904|NCT00614744|FG000|Participant Flow|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
10910905|NCT00614744|FG001|Participant Flow|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
10910906|NCT00614744|OG000|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
10910907|NCT00614744|OG001|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
10910908|NCT00614744|EG000|Reported Event|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
10910909|NCT00614744|EG001|Reported Event|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
10910910|NCT00614822|BG000|Baseline|Carboplatin, Bevacicumab, Premetrexed|Patients (age >18yo) were from 2007 to 2012.. Measurable disease Evaluable disease Stage IV Palliative RT NO brain metastases
10910911|NCT00614822|FG000|Participant Flow|One Arm for Study|"Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease.~Carboplatin, Pemetrexed and Bevacizumab: Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles"
11174246|NCT02020577|FG000|Participant Flow|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
11174247|NCT02020577|FG001|Participant Flow|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
11174248|NCT02020577|OG000|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
10910912|NCT00614822|OG000|Outcome|Carboplatin, Bevacicumab, Premetrexed|Patients (age >18yo) were from 2007 to 2012.. 51 patients with nonsquamous stage IV disease were enrolled over 24 months and followed. The meadian follow up was 49 weeks. Of the 51 patient enrolled, 1 patient was with drawn due to ineligibility. Three other patients were not evaluated for response due to adverse reactions.
10910913|NCT00614822|OG000|Outcome|One Arm for Study|"Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease.~Carboplatin, Pemetrexed and Bevacizumab: Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles"
10910914|NCT00614822|EG000|Reported Event|One Arm for Study|"Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease.~Carboplatin, Pemetrexed and Bevacizumab: Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles"
10910915|NCT00614874|BG000|Baseline|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
10910916|NCT00614874|FG000|Participant Flow|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
10910917|NCT00614874|OG000|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
10910918|NCT00614874|EG000|Reported Event|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
10910919|NCT00614913|BG000|Baseline|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
10910920|NCT00614913|FG000|Participant Flow|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
10910921|NCT00614913|OG000|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
10910922|NCT00614913|EG000|Reported Event|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
10910923|NCT00614926|BG000|Baseline|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
10910924|NCT00614926|BG001|Baseline|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
10910925|NCT00614926|BG002|Baseline|Total|Total of all reporting groups
10910926|NCT00614926|FG000|Participant Flow|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
10910927|NCT00614926|FG001|Participant Flow|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
10910928|NCT00614926|OG000|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
10910929|NCT00614926|OG001|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
10910930|NCT00614926|EG000|Reported Event|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
10910931|NCT00614926|EG001|Reported Event|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
10910932|NCT00614939|BG000|Baseline|Placebo|Placebo
10910933|NCT00614939|BG001|Baseline|Saxa|Saxagliptin 2.5 mg once daily oral dose
10910934|NCT00614939|BG002|Baseline|Total|Total of all reporting groups
10910935|NCT00614939|FG000|Participant Flow|Placebo|Placebo
10910936|NCT00614939|FG001|Participant Flow|Saxa|Saxagliptin 2.5 mg once daily oral dose
10910937|NCT00614939|OG000|Outcome|Placebo|Placebo
10910938|NCT00614939|OG001|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
10910939|NCT00614939|EG000|Reported Event|Placebo|Placebo
10910940|NCT00614939|EG001|Reported Event|Saxa|Saxagliptin 2.5 mg once daily oral dose
10910941|NCT00614991|BG000|Baseline|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
10910942|NCT00614991|BG001|Baseline|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
10910943|NCT00614991|BG002|Baseline|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
10910944|NCT00614991|BG003|Baseline|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
10910945|NCT00614991|BG004|Baseline|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
10910946|NCT00614991|BG005|Baseline|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10910947|NCT00614991|BG006|Baseline|Total|Total of all reporting groups
10910948|NCT00614991|FG000|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
10910949|NCT00614991|FG001|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
10910950|NCT00614991|FG002|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
10910951|NCT00614991|FG003|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
10910952|NCT00614991|FG004|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
10910953|NCT00614991|FG005|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10910954|NCT00614991|OG000|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
10910955|NCT00614991|OG001|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
10910956|NCT00614991|OG002|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
10910957|NCT00614991|OG000|Outcome|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
10910958|NCT00614991|OG001|Outcome|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
10910959|NCT00614991|OG002|Outcome|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
10910960|NCT00614991|OG003|Outcome|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
10910961|NCT00614991|OG004|Outcome|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
10910962|NCT00614991|OG005|Outcome|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10910963|NCT00614991|OG000|Outcome|Group A & B|Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Group B Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
10910964|NCT00614991|OG001|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID"
10910965|NCT00614991|EG000|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
10910966|NCT00614991|EG001|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
10910967|NCT00614991|EG002|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
10910968|NCT00614991|EG003|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
10910969|NCT00614991|EG004|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
10910970|NCT00614991|EG005|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10910971|NCT00615017|BG000|Baseline|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
10910972|NCT00615017|BG001|Baseline|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
10910973|NCT00615017|BG002|Baseline|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
10910974|NCT00615017|BG003|Baseline|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
10910975|NCT00615017|BG004|Baseline|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
10910976|NCT00615017|BG005|Baseline|Placebo|Placebo
10910977|NCT00615017|BG006|Baseline|Total|Total of all reporting groups
10910978|NCT00615017|FG000|Participant Flow|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
10910979|NCT00615017|FG001|Participant Flow|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
10910980|NCT00615017|FG002|Participant Flow|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
10910981|NCT00615017|FG003|Participant Flow|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
11173227|NCT02014402|OG004|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
11173228|NCT02014402|EG000|Reported Event|IG1202-A (Vascular): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173229|NCT02014402|EG001|Reported Event|IG1202-A (Vascular): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173230|NCT02014402|EG002|Reported Event|IG1202-B (Hepatic): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173231|NCT02014402|EG003|Reported Event|IG1202-B (Hepatic): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173232|NCT02014402|EG004|Reported Event|IG1202-C (Soft Tissue): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173233|NCT02014402|EG005|Reported Event|IG1202-C (Soft Tissue): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173234|NCT02014402|EG006|Reported Event|IG1202-D (Spinal): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173235|NCT02014402|EG007|Reported Event|IG1202-D (Spinal): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173236|NCT02014402|EG008|Reported Event|Overall (IG1202-A, -B, -C, and -D): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173237|NCT02014402|EG009|Reported Event|Overall (IG1202-A, -B, -C, and -D): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
11173238|NCT02014441|BG000|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
11173239|NCT02014441|FG000|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
11173240|NCT02014441|OG000|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
11173241|NCT02014441|OG001|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
11173242|NCT02014441|OG002|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
11173243|NCT02014441|EG000|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
11173244|NCT02014467|BG000|Baseline|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
11173245|NCT02014467|BG001|Baseline|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
11173246|NCT02014467|BG002|Baseline|Total|Total of all reporting groups
11173247|NCT02014467|FG000|Participant Flow|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
11173248|NCT02014467|FG001|Participant Flow|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase.Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
11173249|NCT02014467|OG000|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
11173250|NCT02014467|OG001|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
11173251|NCT02014467|EG000|Reported Event|Denosumab 60mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
11173252|NCT02014467|EG001|Reported Event|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
10910982|NCT00615017|FG004|Participant Flow|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
10910983|NCT00615017|FG005|Participant Flow|Placebo|Placebo
10910984|NCT00615017|OG000|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
10910985|NCT00615017|OG001|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
10910986|NCT00615017|OG002|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
10910987|NCT00615017|OG003|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
10910988|NCT00615017|OG004|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
10910989|NCT00615017|OG005|Outcome|Placebo|Placebo
10910990|NCT00615017|EG000|Reported Event|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
10910991|NCT00615017|EG001|Reported Event|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
10910992|NCT00615017|EG002|Reported Event|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
10910993|NCT00615017|EG003|Reported Event|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
10910994|NCT00615017|EG004|Reported Event|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
10910995|NCT00615017|EG005|Reported Event|Placebo|Placebo
10910996|NCT00615030|BG000|Baseline|Total Patients|
10910997|NCT00615030|FG000|Participant Flow|Sequence 1:Indacaterol Morning,Indacaterol Evening, Salmeterol|In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10910998|NCT00615030|FG001|Participant Flow|Sequence 2:Indacaterol Evening,Indacaterol Morning, Placebo|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10910999|NCT00615030|FG002|Participant Flow|Sequence 3: Salmeterol, Placebo, Indacaterol Morning|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911000|NCT00615030|FG003|Participant Flow|Sequence 4: Placebo, Salmeterol, Indacaterol Evening|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911001|NCT00615030|FG004|Participant Flow|Sequence 5: Indacaterol Morning, Placebo, Indacaterol Evening|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10915145|NCT00634166|FG000|Participant Flow|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
10911002|NCT00615030|FG005|Participant Flow|Sequence 6:Indacaterol Evening,Salmeterol, Indacaterol Morning|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911003|NCT00615030|FG006|Participant Flow|Sequence 7: Salmeterol, Indacaterol Evening, Placebo|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911004|NCT00615030|FG007|Participant Flow|Sequence 8: Placebo, Indacaterol Morning, Salmeterol|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911005|NCT00615030|FG008|Participant Flow|Sequence 9:Indacaterol Morning, Salmeterol, Placebo|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911006|NCT00615030|FG009|Participant Flow|Sequence 10: Indacaterol Evening, Placebo, Salmeterol|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911007|NCT00615030|FG010|Participant Flow|Sequence 11:Salmeterol,Indacaterol Morning,Indacaterol Evening|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911008|NCT00615030|FG011|Participant Flow|Sequence 12: Placebo, Indacaterol Evening, Indacaterol Morning|In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911009|NCT00615030|OG000|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via single dose dry powder inhaler (SDDPI) and placebo to salmeterol delivered via dry powder inhaler (DPI). Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911010|NCT00615030|OG001|Outcome|Placebo|During evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911011|NCT00615030|OG000|Outcome|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911012|NCT00615030|OG001|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911013|NCT00615030|OG002|Outcome|Salmeterol Morning|In the morning, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911014|NCT00615030|OG003|Outcome|Salmeterol Evening|In the evening, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911015|NCT00615030|OG004|Outcome|Placebo Morning|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer's proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911016|NCT00615030|OG005|Outcome|Placebo Evening|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer's proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911017|NCT00615030|EG000|Reported Event|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
10911018|NCT00615030|EG001|Reported Event|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
10911019|NCT00615030|EG002|Reported Event|Salmeterol|Salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning along with placebo matching indacaterol delivered by single dose dry powder inhaler (SDDPI). The second dose of salmeterol was administered in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
10911020|NCT00615030|EG003|Reported Event|Placebo|During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
10911021|NCT00615056|BG000|Baseline|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911022|NCT00615056|BG001|Baseline|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911023|NCT00615056|BG002|Baseline|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911024|NCT00615056|BG003|Baseline|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911025|NCT00615056|BG004|Baseline|Total|Total of all reporting groups
11174249|NCT02020577|OG001|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
10911026|NCT00615056|FG000|Participant Flow|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911027|NCT00615056|FG001|Participant Flow|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911028|NCT00615056|FG002|Participant Flow|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911029|NCT00615056|FG003|Participant Flow|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911030|NCT00615056|OG000|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911031|NCT00615056|OG001|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911032|NCT00615056|OG002|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911033|NCT00615056|OG003|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
11174250|NCT02020577|OG002|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
10911034|NCT00615056|EG000|Reported Event|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911035|NCT00615056|EG001|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911036|NCT00615056|EG002|Reported Event|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911037|NCT00615056|EG003|Reported Event|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
10911038|NCT00615069|BG000|Baseline|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment.
10911039|NCT00615069|FG000|Participant Flow|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment. Participant Flow results reflect the final (5 year) data.
10911040|NCT00615069|OG000|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
11174251|NCT02020577|EG000|Reported Event|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
10911041|NCT00615069|EG000|Reported Event|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA).
10911042|NCT00615108|BG000|Baseline|Hypertension Patients|Telmisartan 40mg or 80 mg
10911043|NCT00615108|FG000|Participant Flow|Hypertension Patients|Telmisartan 40mg or 80 mg
10911044|NCT00615108|OG000|Outcome|Micardis 40mg|Telmisartan 40 mg
10911045|NCT00615108|OG001|Outcome|Micardis 80mg|Telmisartan 80 mg
10911046|NCT00615108|OG002|Outcome|Total|Telmisartan 40mg or 80 mg
10911047|NCT00615108|EG000|Reported Event|Hypertension Patients|Telmisartan 40mg or 80 mg
10911048|NCT00615199|BG000|Baseline|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
10911049|NCT00615199|BG001|Baseline|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
10911050|NCT00615199|BG002|Baseline|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
10911051|NCT00615199|BG003|Baseline|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
10911052|NCT00615199|BG004|Baseline|Total|Total of all reporting groups
10911053|NCT00615199|FG000|Participant Flow|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
10911054|NCT00615199|FG001|Participant Flow|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
11174252|NCT02020577|EG001|Reported Event|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
10911055|NCT00615199|FG002|Participant Flow|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
10911056|NCT00615199|FG003|Participant Flow|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
10911057|NCT00615199|OG000|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
10911058|NCT00615199|OG001|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
10911059|NCT00615199|OG002|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
10911060|NCT00615199|OG003|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
10911061|NCT00615199|EG000|Reported Event|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
10911062|NCT00615199|EG001|Reported Event|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
10911063|NCT00615199|EG002|Reported Event|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
10911064|NCT00615199|EG003|Reported Event|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
10911065|NCT00615264|BG000|Baseline|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5mL Lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
10911066|NCT00615264|BG001|Baseline|Placebo|"Mannitol 40 mg in 0.5 mL Lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
10911067|NCT00615264|BG002|Baseline|Total|Total of all reporting groups
10911068|NCT00615264|FG000|Participant Flow|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
10911069|NCT00615264|FG001|Participant Flow|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
10911070|NCT00615264|OG000|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
10911071|NCT00615264|OG001|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
10911072|NCT00615264|EG000|Reported Event|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
10911073|NCT00615264|EG001|Reported Event|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
10911074|NCT00615290|BG000|Baseline|Aptivus|Patients treated by Aptivus in daily practice
10911075|NCT00615290|FG000|Participant Flow|Aptivus|Patients treated by Aptivus in daily practice
10911076|NCT00615290|OG000|Outcome|Aptivus|Patients treated by Aptivus in daily practice
10911077|NCT00615290|EG000|Reported Event|Aptivus|Patients treated by Aptivus in daily practice
10911078|NCT00615420|BG000|Baseline|Honey|"Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed~manuka honey: Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy."
10911079|NCT00615420|BG001|Baseline|Placebo|"Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed~placebo gel: Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy."
10911080|NCT00615420|BG002|Baseline|Total|Total of all reporting groups
10911081|NCT00615420|FG000|Participant Flow|Honey|"Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed~manuka honey: Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy."
10911082|NCT00615420|FG001|Participant Flow|Placebo|"Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed~placebo gel: Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy."
11174253|NCT02020577|EG002|Reported Event|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
10911083|NCT00615420|OG000|Outcome|Honey|"Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed~manuka honey: Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy."
10911084|NCT00615420|OG001|Outcome|Placebo|"Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed~placebo gel: Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy."
10911085|NCT00615420|EG000|Reported Event|Honey|"Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed~manuka honey: Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy."
10911086|NCT00615420|EG001|Reported Event|Placebo|"Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed~placebo gel: Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy."
10911087|NCT00615433|BG000|Baseline|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
10911088|NCT00615433|BG001|Baseline|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
10911089|NCT00615433|BG002|Baseline|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
10911090|NCT00615433|BG003|Baseline|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
10911091|NCT00615433|BG004|Baseline|Total|Total of all reporting groups
10911092|NCT00615433|FG000|Participant Flow|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
10911093|NCT00615433|FG001|Participant Flow|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
10911094|NCT00615433|FG002|Participant Flow|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
10911095|NCT00615433|FG003|Participant Flow|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
10911096|NCT00615433|OG000|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
10911097|NCT00615433|OG001|Outcome|120mg|3 40 mg tablets taken orally once a day.
10911098|NCT00615433|OG002|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
10911099|NCT00615433|OG003|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
10911100|NCT00615433|OG001|Outcome|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
11174254|NCT02020590|BG000|Baseline|ALLOB® Implantation|"One arm: ALLOB® Implantation~ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia."
11174255|NCT02020590|FG000|Participant Flow|ALLOB® Implantation|"One arm: ALLOB® Implantation~ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia."
10911101|NCT00615433|EG000|Reported Event|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
10911102|NCT00615433|EG001|Reported Event|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
10911103|NCT00615433|EG002|Reported Event|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
10911104|NCT00615433|EG003|Reported Event|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
10911105|NCT00615459|BG000|Baseline|Total Patients|The safety population, included all patients who received at least one dose of study drug.
10911106|NCT00615459|FG000|Participant Flow|Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg|In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911107|NCT00615459|FG001|Participant Flow|Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium|In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
10911108|NCT00615459|FG002|Participant Flow|Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo|In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
10911109|NCT00615459|FG003|Participant Flow|Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg|In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
10911110|NCT00615459|OG000|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911111|NCT00615459|OG001|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911112|NCT00615459|OG002|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911113|NCT00615459|OG003|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
10911114|NCT00615459|EG000|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via single dose dry powder inhaler (SDDPI) and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
11174256|NCT02020590|OG000|Outcome|ALLOB® Implantation|"One arm: ALLOB® Implantation~ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia."
11174257|NCT02020590|EG000|Reported Event|ALLOB® Implantation|"One arm: ALLOB® Implantation~ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia."
11174258|NCT02020616|BG000|Baseline|Placebo|Placebo administered SC QW for 12 weeks
10911115|NCT00615459|EG001|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
10911116|NCT00615459|EG002|Reported Event|Tiotropium 18 μg|Tiotropium 18 μg once daily delivered via inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
10911117|NCT00615459|EG003|Reported Event|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
10911118|NCT00615472|BG000|Baseline|Inhaled Anesthesia|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
10911119|NCT00615472|BG001|Baseline|Intravenous Anesthesia|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed"
10911120|NCT00615472|BG002|Baseline|Total|Total of all reporting groups
10911121|NCT00615472|FG000|Participant Flow|Inhaled Anesthesia|Inhaled Anesthesia - isoflurane
10911122|NCT00615472|FG001|Participant Flow|Intravenous Anesthesia|Intravenous Anesthesia - propofol, remifentanil
10911123|NCT00615472|OG000|Outcome|Group 1|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
10911124|NCT00615472|OG001|Outcome|Group 2|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
10911125|NCT00615472|EG000|Reported Event|Group 1|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
10911126|NCT00615472|EG001|Reported Event|Group 2|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
10911127|NCT00615550|BG000|Baseline|Placebo|placebo vaginal gel
10911128|NCT00615550|BG001|Baseline|Prochieve|Progesterone 8% Vaginal Gel
10911129|NCT00615550|BG002|Baseline|Total|Total of all reporting groups
10911130|NCT00615550|FG000|Participant Flow|Placebo|placebo vaginal gel
10911131|NCT00615550|FG001|Participant Flow|Prochieve|Progesterone 8% Vaginal Gel
10911132|NCT00615550|OG000|Outcome|Placebo|placebo vaginal gel
10911133|NCT00615550|OG001|Outcome|Prochieve|Progesterone 8% Vaginal Gel
10911134|NCT00615550|EG000|Reported Event|Placebo|placebo vaginal gel
10911135|NCT00615550|EG001|Reported Event|Prochieve|Progesterone 8% Vaginal Gel
10911136|NCT00615589|BG000|Baseline|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.~The Fludarabine shall be administered prior to the Busulfan each day."
10911137|NCT00615589|FG000|Participant Flow|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily over 4 hours on days -5, -4, -3, and -2.~The Fludarabine shall be administered prior to the Busulfan each day."
10911138|NCT00615589|OG000|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.~The Fludarabine shall be administered prior to the Busulfan each day."
10911139|NCT00615589|OG000|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily over 4 hours on days -5, -4, -3, and -2.~The Fludarabine shall be administered prior to the Busulfan each day."
11174259|NCT02020616|BG001|Baseline|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
10911140|NCT00615589|EG000|Reported Event|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.~The Fludarabine shall be administered prior to the Busulfan each day."
10911141|NCT00615719|BG000|Baseline|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
10911142|NCT00615719|FG000|Participant Flow|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
10911143|NCT00615719|OG000|Outcome|Computed Tomographic Coronary Angiography for Chest Pain Evalu|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA)
10911144|NCT00615719|EG000|Reported Event|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
10911145|NCT00615784|BG000|Baseline|Bexarotene 300mg/m2|Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
10911146|NCT00615784|FG000|Participant Flow|Bexarotene 300mg/m2 Daily|Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
10911147|NCT00615784|OG000|Outcome|Bexarotene 300mg/m2|Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
10911148|NCT00615784|EG000|Reported Event|Bexarotene 300mg/m2|Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
10911149|NCT00615836|BG000|Baseline|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
10911150|NCT00615836|BG001|Baseline|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
10911151|NCT00615836|BG002|Baseline|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
10911152|NCT00615836|BG003|Baseline|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
10911153|NCT00615836|BG004|Baseline|Total|Total of all reporting groups
10911154|NCT00615836|FG000|Participant Flow|Desmopressin Melt 10 μg|"Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31.~During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg)."
10911155|NCT00615836|FG001|Participant Flow|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
10911156|NCT00615836|FG002|Participant Flow|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
10911157|NCT00615836|FG003|Participant Flow|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
10911158|NCT00615836|FG004|Participant Flow|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.
10911159|NCT00615836|OG000|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
10911160|NCT00615836|OG001|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
10911161|NCT00615836|OG002|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
10911162|NCT00615836|OG003|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
10911163|NCT00615836|OG000|Outcome|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt.
10911164|NCT00615836|OG001|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
10911165|NCT00615836|OG002|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
10911166|NCT00615836|OG003|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
10911167|NCT00615836|OG004|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
11091234|NCT01533935|BG000|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were:~Oral inhalation of placebo~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
11091235|NCT01533935|FG000|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg"
11091236|NCT01533935|FG001|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo"
11091237|NCT01533935|FG002|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
11091238|NCT01533935|FG003|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
11091239|NCT01533935|FG004|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg"
11091240|NCT01533935|OG000|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
11091241|NCT01533935|OG001|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091242|NCT01533935|OG002|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091243|NCT01533935|OG003|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091244|NCT01533935|OG004|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091245|NCT01533935|EG000|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
11091246|NCT01533935|EG001|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091247|NCT01533935|EG002|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091248|NCT01533935|EG003|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091249|NCT01533935|EG004|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
11091250|NCT01533948|BG000|Baseline|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
11091251|NCT01533948|FG000|Participant Flow|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
11174260|NCT02020616|BG002|Baseline|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
11174261|NCT02020616|BG003|Baseline|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
11174262|NCT02020616|BG004|Baseline|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
11174263|NCT02020616|BG005|Baseline|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
11173253|NCT02014480|BG000|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
11173254|NCT02014480|FG000|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol trifenatate (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
10911168|NCT00615836|EG000|Reported Event|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt.
10911169|NCT00615836|EG001|Reported Event|Desmopressin Melt 10 μg|Participants received desmopressin melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
10911170|NCT00615836|EG002|Reported Event|Desmopressin Melt 25 μg|Participants received desmopressin melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
10911171|NCT00615836|EG003|Reported Event|Desmopressin Melt 50 μg|Participants received desmopressin melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
10911172|NCT00615836|EG004|Reported Event|Desmopressin Melt 100 μg|Participants received desmopressin melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
10911173|NCT00615901|BG000|Baseline|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
10911174|NCT00615901|FG000|Participant Flow|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
10911175|NCT00615901|OG000|Outcome|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
10911176|NCT00615901|EG000|Reported Event|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
10911177|NCT00615914|BG000|Baseline|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated until symptom control was achieved. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
10911178|NCT00615914|FG000|Participant Flow|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)
10911179|NCT00615914|OG000|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
10911180|NCT00615914|OG000|Outcome|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
10911181|NCT00615914|EG000|Reported Event|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg) was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
10911182|NCT00615927|BG000|Baseline|Astrocytoma|Grade II Astrocytoma
10911183|NCT00615927|BG001|Baseline|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
10911184|NCT00615927|BG002|Baseline|Total|Total of all reporting groups
10911185|NCT00615927|FG000|Participant Flow|Astrocytoma|Grade II Astrocytoma
10911186|NCT00615927|FG001|Participant Flow|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
10911187|NCT00615927|OG000|Outcome|Astrocytoma|Grade II Astrocytoma
10911188|NCT00615927|OG001|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
10911189|NCT00615927|EG000|Reported Event|Astrocytoma|Grade II Astrocytoma
10911190|NCT00615927|EG001|Reported Event|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
10911191|NCT00615992|BG000|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
10911192|NCT00615992|FG000|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
10911193|NCT00615992|OG000|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
10911194|NCT00615992|EG000|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
10911195|NCT00616018|BG000|Baseline|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
10911196|NCT00616018|FG000|Participant Flow|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
10911197|NCT00616018|OG000|Outcome|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
10911198|NCT00616018|OG000|Outcome|Acetaminophen|acetaminophen treatment group
10911199|NCT00616018|EG000|Reported Event|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
10911200|NCT00616109|BG000|Baseline|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
10911201|NCT00616109|FG000|Participant Flow|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
10911202|NCT00616109|OG000|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
10911203|NCT00616109|OG000|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
10911204|NCT00616109|EG000|Reported Event|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
10911205|NCT00616122|BG000|Baseline|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
10911206|NCT00616122|FG000|Participant Flow|Phase I, Dose 1|"One cycle = 21 days~Sunitinib only (12.5 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg twice a day (BID) 2 days/week).~Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level."
10911207|NCT00616122|FG001|Participant Flow|Phase I, Dose 2|"One cycle = 21 days~Sunitinib only (25 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week).~Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level."
10911208|NCT00616122|FG002|Participant Flow|Phase I, Dose 3|"One cycle = 21 days~Sunitinib only (37.5 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week).~Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level."
10911209|NCT00616122|FG003|Participant Flow|Phase II|"37.5mg sunitinib during the 2-week lead-in period followed by either:~37.5mg sunitinib~metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week)(CM)~25mg sunitinib~metronomic CM (50mg/day)~methotrexate (2.5mg BID 2 days/week)"
10911210|NCT00616122|OG000|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
10911211|NCT00616122|EG000|Reported Event|Phase I, Dose 1|"One cycle = 21 days~Sunitinib only (12.5 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week).~Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level."
10911212|NCT00616122|EG001|Reported Event|Phase I, Dose 2|"One cycle = 21 days~Sunitinib only (25 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week).~Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level."
10911213|NCT00616122|EG002|Reported Event|Phase I, Dose 3|"One cycle = 21 days~Sunitinib only (37.5 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week).~Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level."
10911214|NCT00616122|EG003|Reported Event|Phase II|"37.5mg sunitinib during the 2-week lead-in period followed by either:~37.5mg sunitinib~metronomic CM (50mg/day)~methotrexate (2.5mg BID 2 days/week)~or~25mg sunitinib~metronomic CM (50mg/day)~methotrexate (2.5mg BID 2 days/week)~(dose reduction due to a protocol amendment)"
10911215|NCT00616200|BG000|Baseline|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
10911216|NCT00616200|FG000|Participant Flow|Standard Diet Then Very Low Carbohydrate Diet|Two weeks of a carbohydrate rich diet was followed by four weeks of A Very Low Carbohydrate Diet. VLCD = <20g/day of carbohydrates
10911217|NCT00616200|OG000|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
10911218|NCT00616200|EG000|Reported Event|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
10911219|NCT00616239|BG000|Baseline|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
10911220|NCT00616239|FG000|Participant Flow|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
10911221|NCT00616239|OG000|Outcome|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
10911222|NCT00616239|EG000|Reported Event|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
10911223|NCT00616421|BG000|Baseline|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age.
10911224|NCT00616421|BG001|Baseline|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day1.
10911225|NCT00616421|BG002|Baseline|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1.
10911226|NCT00616421|BG003|Baseline|Total|Total of all reporting groups
10911227|NCT00616421|FG000|Participant Flow|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
10911228|NCT00616421|FG001|Participant Flow|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
10911229|NCT00616421|FG002|Participant Flow|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
10911230|NCT00616421|OG000|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
10911231|NCT00616421|OG001|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
10911232|NCT00616421|OG000|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
10911233|NCT00616421|OG001|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age.
10911234|NCT00616421|OG002|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
10911235|NCT00616421|OG003|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
10911236|NCT00616421|OG001|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age
10911237|NCT00616421|OG003|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 6 to 10 years of age
10911238|NCT00616421|OG000|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
10911239|NCT00616421|OG001|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
10911240|NCT00616421|OG000|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 2 to 5 years of age.
10911241|NCT00616421|OG001|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 2 to 5 years of age.
10911242|NCT00616421|OG000|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 6 to 10 years of age.
10911243|NCT00616421|OG001|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 6 to 10 years of age.
10911244|NCT00616421|OG001|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
10911245|NCT00616421|EG000|Reported Event|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
10911246|NCT00616421|EG001|Reported Event|MenACWY-CRM (1 Dose)_2 to 5 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age.
10911247|NCT00616421|EG002|Reported Event|MenACWY-CRM (1 Dose)_6 to 10 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age.
11174264|NCT02020616|BG006|Baseline|2 mg Exenatide ER|2 mg Exenatide ER administered SC QW for 12 weeks
10911248|NCT00616421|EG003|Reported Event|Licensed Polysaccharide Vaccine_2 to 5 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age.
11091252|NCT01533948|OG000|Outcome|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
11091253|NCT01533948|EG000|Reported Event|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11091254|NCT01533974|BG000|Baseline|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
11091255|NCT01533974|BG001|Baseline|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
11091256|NCT01533974|BG002|Baseline|Total|Total of all reporting groups
11091257|NCT01533974|FG000|Participant Flow|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
11091258|NCT01533974|FG001|Participant Flow|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
11091259|NCT01533974|OG000|Outcome|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
11091260|NCT01533974|OG001|Outcome|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
11091261|NCT01533974|EG000|Reported Event|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
11091262|NCT01533974|EG001|Reported Event|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
11091263|NCT01534013|BG000|Baseline|Closed-loop Insulin Delivery|"The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes~The Imperial College Closed-Loop Insulin Delivery System: The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system."
11091264|NCT01534013|BG001|Baseline|Open-loop Insulin Delivery|standard insulin pump therapy
11091265|NCT01534013|BG002|Baseline|Total|Total of all reporting groups
11091266|NCT01534013|FG000|Participant Flow|Closed-loop Insulin Delivery|"The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes~The Imperial College Closed-Loop Insulin Delivery System: The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system."
11091267|NCT01534013|FG001|Participant Flow|Open-loop Insulin Delivery|glucose sensor and insulin pump
11091268|NCT01534013|OG000|Outcome|Closed-loop Insulin Delivery|"The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes~The Imperial College Closed-Loop Insulin Delivery System: The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system."
11091269|NCT01534013|OG001|Outcome|Open-loop Insulin Delivery|sensor augmented pump therapy
11091270|NCT01534013|EG000|Reported Event|Closed-loop Insulin Delivery|"The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes~The Imperial College Closed-Loop Insulin Delivery System: The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system."
11091271|NCT01534013|EG001|Reported Event|Open-loop|sensor augmented pump
11091272|NCT01534052|BG000|Baseline|Enzalutamide|Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
11091273|NCT01534052|FG000|Participant Flow|Enzalutamide|Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
11091274|NCT01534052|OG000|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
11091275|NCT01534052|EG000|Reported Event|Enzalutimide|Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
11091276|NCT01534078|BG000|Baseline|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
11174265|NCT02020616|BG007|Baseline|Total|Total of all reporting groups
11174266|NCT02020616|FG000|Participant Flow|Placebo|Placebo administered by subcutaneous injection (SC) once a week (Q1W) for 12 weeks
11091277|NCT01534078|FG000|Participant Flow|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine (AVD)~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
11091278|NCT01534078|OG000|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
11091279|NCT01534078|EG000|Reported Event|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
11091280|NCT01534182|BG000|Baseline|Fingolimod|Participants received 0.5 mg orally once a day.
11091281|NCT01534182|BG001|Baseline|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
11091282|NCT01534182|BG002|Baseline|Total|Total of all reporting groups
11091283|NCT01534182|FG000|Participant Flow|Fingolimod|Participants received 0.5 mg orally once a day.
11091284|NCT01534182|FG001|Participant Flow|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
11174267|NCT02020616|FG001|Participant Flow|7 mg LY3053102|7 mg LY3053102 administered SC Q1W for 12 weeks.
10911249|NCT00616421|EG004|Reported Event|Licensed Polysaccharide Vaccine_6 to 10 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age.
11091285|NCT01534182|OG000|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
11091286|NCT01534182|OG001|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
11091287|NCT01534182|EG000|Reported Event|Fingolimod|Participants received 0.5 mg orally once a day.
11091288|NCT01534182|EG001|Reported Event|Standard Disease Modifying Therapy (DMT): Interferon Beta-1a|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week
11091289|NCT01534182|EG002|Reported Event|Standard Disease Modifying Therapy: Glatiramer Acetate|Patients who received glatiramer acetate (GA), 20 mg subcutaneously once a day.
11091290|NCT01534195|BG000|Baseline|Prednisolone|"Prednisolone Sodium Phosphate Ophthalmic Solution, 1%~Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days."
11091291|NCT01534195|BG001|Baseline|Placebo|"Tears Naturale II Ophthalmic Solution, 1%~Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days"
11091292|NCT01534195|BG002|Baseline|Total|Total of all reporting groups
11091293|NCT01534195|FG000|Participant Flow|Prednisolone|"Prednisolone Sodium Phosphate Ophthalmic Solution, 1%~Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye four times/day (QID) for 8 days."
11091294|NCT01534195|FG001|Participant Flow|Placebo|"Tears Naturale II Ophthalmic Solution, 1%~Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days"
11091295|NCT01534195|OG000|Outcome|Prednisolone|"Prednisolone Sodium Phosphate Ophthalmic Solution, 1%~Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days."
11091296|NCT01534195|OG001|Outcome|Placebo|"Tears Naturale II Ophthalmic Solution, 1%~Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days"
11091297|NCT01534195|EG000|Reported Event|Prednisolone|"Prednisolone Sodium Phosphate Ophthalmic Solution, 1%~Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 8 days."
11091298|NCT01534195|EG001|Reported Event|Placebo|"Tears Naturale II Ophthalmic Solution, 1%~Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 8 days"
11091299|NCT01534208|BG000|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
11091300|NCT01534208|BG001|Baseline|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
11091301|NCT01534208|BG002|Baseline|Total|Total of all reporting groups
11091302|NCT01534208|FG000|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal, oral, 12.5 mg capsule, taken once daily"
11091303|NCT01534208|FG001|Participant Flow|Androxal 25 mg|"Androxal 25 mg daily~Androxal, oral, 25 mg capsule, taken once daily"
11091304|NCT01534208|OG000|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
11091305|NCT01534208|OG001|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
11091306|NCT01534208|EG000|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
11091307|NCT01534208|EG001|Reported Event|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
11091308|NCT01534260|BG000|Baseline|Phase I Dose Escalating|escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
11091309|NCT01534260|BG001|Baseline|Phase II at MTD|patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
11091310|NCT01534260|BG002|Baseline|Total|Total of all reporting groups
11091311|NCT01534260|FG000|Participant Flow|Phase I Dose Escalating|escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
11091312|NCT01534260|FG001|Participant Flow|Phase II at MTD|patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
11091313|NCT01534260|OG000|Outcome|Phase I Dose Escalating|escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
11091314|NCT01534260|OG000|Outcome|Phase II at MTD|patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
11091315|NCT01534260|EG000|Reported Event|Phase I Dose Escalating|escalating dose cohorts of sorafenib, vorinostat and bortezomib. All cohorts will receive sorafenib from day 1 to 14 and vorinostat from day 1 to 4 and day 8 to 12. Bortezomib will be given on days 1 and 8 for all cohorts, with cohorts 4 and 5 also receiving bortezomib on days 4 and 11 for cycles 1 through 4. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
11091316|NCT01534260|EG001|Reported Event|Phase II at MTD|patients received sorafenib at 400 mg bid from day 1 to 14 and vorinostat 200 mg bid from day 1 to 14. Bortezomib will be given at 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-4, and then on days 1 and 8 for cycle 5 and beyond. Bortezomib will be given on days 1 and 8 beyond 4 cycles to reduce the risk of neurotoxicity.
11091317|NCT01534273|BG000|Baseline|Placebo|Placebo: once daily (QD) oral dosing for 14 consecutive days
11091318|NCT01534273|BG001|Baseline|35 mg LY2886721|Participants received 35 mg LY2886721: oral dosing for 14 consecutive days
11091319|NCT01534273|BG002|Baseline|70 mg LY2886721|Participants received 70 mg LY2886721: single oral dose followed by QD oral dosing for 14 consecutive days or single oral dose.
11091320|NCT01534273|BG003|Baseline|140 mg LY2886721|Participants received 140 mg LY2886721: single oral dose
11091321|NCT01534273|BG004|Baseline|Total|Total of all reporting groups
11091322|NCT01534273|FG000|Participant Flow|Placebo (Cohort A)|Placebo: once daily (QD) oral dosing for 14 consecutive days
11091323|NCT01534273|FG001|Participant Flow|35 mg LY2886721 (Cohort A)|35 milligrams (mg) LY2886721: QD oral dosing for 14 consecutive days
11091324|NCT01534273|FG002|Participant Flow|Placebo (Cohort B)|Placebo: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2)
11091325|NCT01534273|FG003|Participant Flow|70 mg LY2886721 (Cohort B)|70 mg LY2886721: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2)
11091326|NCT01534273|FG004|Participant Flow|Placebo (Cohort C)|Placebo: single oral dose
11091327|NCT01534273|FG005|Participant Flow|70 mg LY2886721 (Cohort C)|70 mg LY2886721: single oral dose
11091328|NCT01534273|FG006|Participant Flow|140 mg LY2886721 (Cohort C)|140 mg LY2886721: single oral dose
11091329|NCT01534273|OG000|Outcome|Placebo|Placebo: QD oral dosing for 14 consecutive days (Cohort A), single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) (Cohort B), or single oral dose (Cohort C)
11091330|NCT01534273|OG001|Outcome|35 mg LY2886721|35 mg LY2886721: QD oral dosing for 14 consecutive days (Cohort A)
11091331|NCT01534273|OG002|Outcome|70 mg LY2886721 Multiple Dose|70 mg LY2886721: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) (Cohort B)
11091332|NCT01534273|OG003|Outcome|70 mg LY2886721 Single Dose|70 mg LY2886721: single oral dose (Cohort B [Period 1] and Cohort C)
11091333|NCT01534273|OG004|Outcome|140 mg LY2886721|140 mg LY2886721: single oral dose (Cohort C)
11091334|NCT01534273|OG000|Outcome|70 mg LY2886721 Single Dose|70 mg LY2886721: single oral dose (Cohort B [Period 1] and Cohort C)
11091335|NCT01534273|OG001|Outcome|140 mg LY2886721|140 mg LY2886721: single oral dose (Cohort C)
11091336|NCT01534273|OG000|Outcome|35 mg LY2886721|35 mg LY2886721: QD oral dosing for 14 consecutive days (Cohort A)
11091337|NCT01534273|OG001|Outcome|70 mg LY2886721 Multiple Dose|70 mg LY2886721: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) (Cohort B)
10911250|NCT00616434|BG000|Baseline|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
11091338|NCT01534273|OG000|Outcome|Placebo (Cohort B)|Placebo: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2)
11091339|NCT01534273|OG001|Outcome|70 mg LY2886721 Multiple Dose (Cohort B)|70 mg LY2886721: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2)
11091340|NCT01534273|OG000|Outcome|Placebo (Cohort C)|Placebo: single oral dose
11091341|NCT01534273|OG001|Outcome|70 mg LY2886721 (Cohort C)|70 mg LY2886721: single oral dose
11091342|NCT01534273|OG002|Outcome|140 mg LY2886721 (Cohort C)|140 mg LY2886721: single oral dose
11091343|NCT01534273|EG000|Reported Event|Placebo|Placebo: QD oral dosing for 14 consecutive days (Cohort A), single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) (Cohort B), or single oral dose (Cohort C)
11091344|NCT01534273|EG001|Reported Event|35 mg LY2886721|35 mg LY2886721: QD oral dosing for 14 consecutive days (Cohort A)
11091345|NCT01534273|EG002|Reported Event|70 mg LY2886721 Multiple Dose|70 mg LY2886721: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) (Cohort B)
11091346|NCT01534273|EG003|Reported Event|70 mg LY2886721 Single Dose|70 mg LY2886721: single oral dose(Cohort B [Period 1] and Cohort C)
11091347|NCT01534273|EG004|Reported Event|140 mg LY2886721|140 mg LY2886721: single oral dose (Cohort C)
11174268|NCT02020616|FG002|Participant Flow|15 mg LY3053102|15 mg LY3053102 administered SC Q1W for 12 weeks.
11091348|NCT01534351|BG000|Baseline|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091349|NCT01534351|BG001|Baseline|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091350|NCT01534351|BG002|Baseline|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091351|NCT01534351|BG003|Baseline|Total|Total of all reporting groups
11091352|NCT01534351|FG000|Participant Flow|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091353|NCT01534351|FG001|Participant Flow|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091354|NCT01534351|FG002|Participant Flow|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091355|NCT01534351|OG000|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091356|NCT01534351|OG001|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091357|NCT01534351|OG002|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091358|NCT01534351|EG000|Reported Event|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091359|NCT01534351|EG001|Reported Event|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091360|NCT01534351|EG002|Reported Event|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
11091361|NCT01534416|BG000|Baseline|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
11091362|NCT01534416|BG001|Baseline|Saline|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
11091363|NCT01534416|BG002|Baseline|Total|Total of all reporting groups
11091364|NCT01534416|FG000|Participant Flow|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
11091365|NCT01534416|FG001|Participant Flow|Saline|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
11091366|NCT01534416|OG000|Outcome|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
11091367|NCT01534416|OG001|Outcome|Saline|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
11091368|NCT01534416|OG000|Outcome|Bupivacaine|"Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision and admitted for pain management.~Participants who requested admission specifically for pain management."
11091369|NCT01534416|OG001|Outcome|Bupivacaine Discharged|Subjects who received bupivacaine and epinephrine and discharged home after surgery. Participants in the Bupivacaine arm who were not admitted.
11091370|NCT01534416|OG002|Outcome|Saline Group|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management. participants in the Saline arm who requested admission specifically for pain management.
11091371|NCT01534416|OG003|Outcome|Saline Discharged Participants|Subjects who received saline and discharged after surgery. Participants in the Saline arm who were discharged after procedure and not admitted.
11091372|NCT01534416|OG000|Outcome|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision and admitted for pain management
11091373|NCT01534416|OG001|Outcome|Saline Group|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management
11091374|NCT01534416|OG000|Outcome|Bupivacaine Narcotics Use|
11091375|NCT01534416|OG001|Outcome|Saline Narcotics Use|
11091376|NCT01534416|OG002|Outcome|Bupivacaine OTC Analgesics Use|OTC - over-the-counter
11091377|NCT01534416|OG003|Outcome|Saline OTC Analgesics Use|
11091378|NCT01534416|EG000|Reported Event|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
11091379|NCT01534416|EG001|Reported Event|Saline|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
11091380|NCT01534520|BG000|Baseline|Group 1: Intravaginal 2% Lidocaine Gel|"4mL of 2% lidocaine gel for vaginal self-administration~)"
11091381|NCT01534520|BG001|Baseline|Group 2: Intravaginal Placebo Gel|4mL placebo gel (K-Y Jelly) for vaginal self-administration
11091382|NCT01534520|BG002|Baseline|Total|Total of all reporting groups
11091383|NCT01534520|FG000|Participant Flow|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
11091384|NCT01534520|FG001|Participant Flow|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
11091385|NCT01534520|OG000|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Placebo: KY Jelly"
11091386|NCT01534520|OG001|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
11091387|NCT01534520|OG000|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
11091388|NCT01534520|OG001|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Placebo: KY Jelly"
11091389|NCT01534520|OG000|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
11091390|NCT01534520|OG001|Outcome|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
11091391|NCT01534520|EG000|Reported Event|Placebo|"Intravaginal insertion of 4mL placebo gel~Placebo: KY Jelly"
11091392|NCT01534520|EG001|Reported Event|Study Drug|"Intravaginal insertion of 4mL 2% lidocaine gel~Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
11091393|NCT01534533|BG000|Baseline|Placebo|starch in hard shell gelatine capsules
11091394|NCT01534533|BG001|Baseline|Lutein Group|20mg lutein per day
11091395|NCT01534533|BG002|Baseline|Lutein and Lycopene Group|lutein plus lycopene group
11091396|NCT01534533|BG003|Baseline|Normal Lutein Group|subjects without early atherosclerosis
11091397|NCT01534533|BG004|Baseline|Total|Total of all reporting groups
11091398|NCT01534533|FG000|Participant Flow|Placebo|starch in hard shell gelatine capsules
11091399|NCT01534533|FG001|Participant Flow|Lutein Group|20mg lutein per day
11091400|NCT01534533|FG002|Participant Flow|Lutein and Lycopene Group|lutein plus lycopene group
11091401|NCT01534533|FG003|Participant Flow|Normal Lutein Group|subjects without early atherosclerosis
11091402|NCT01534533|OG000|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
11091403|NCT01534533|OG001|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
11091404|NCT01534533|OG002|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
11091405|NCT01534533|OG003|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
11091406|NCT01534533|OG002|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
11091407|NCT01534533|OG002|Outcome|Combination Group (LL Group)|early atherosclerosis cases received 20mg lutein and 20mg lycopene
10911251|NCT00616434|BG001|Baseline|Placebo|Placebo IM injection twice weekly for 12 weeks
10911252|NCT00616434|BG002|Baseline|Total|Total of all reporting groups
11091408|NCT01534533|EG000|Reported Event|Placebo|early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day
11091409|NCT01534533|EG001|Reported Event|Lutein Group|early atherosclerosis cases, received 20mg lutein, once a day
11091410|NCT01534533|EG002|Reported Event|Combination Group|early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day
11091411|NCT01534533|EG003|Reported Event|Normal Lutein Control Group|20mg lutein for subjects free from atherosclerosis, once a day
11091412|NCT01534637|BG000|Baseline|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
11091413|NCT01534637|FG000|Participant Flow|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
11091414|NCT01534637|OG000|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
11173255|NCT02014480|FG001|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11174269|NCT02020616|FG003|Participant Flow|50 mg LY3053102|50 mg LY3053102 administered SC Q1W for 12 weeks.
11174270|NCT02020616|FG004|Participant Flow|100 mg LY3053102|100 mg LY3053102 administered SC Q1W for 12 weeks.
11091415|NCT01534637|EG000|Reported Event|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
11091416|NCT01534663|BG000|Baseline|Placebo|"The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.~Placebo: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days."
11091417|NCT01534663|BG001|Baseline|Glutamine/Fishoil|"3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d).~Glutamine and Fish Oil Supplementation: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days."
11091418|NCT01534663|BG002|Baseline|Total|Total of all reporting groups
11091419|NCT01534663|FG000|Participant Flow|Placebo|"The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.~Placebo: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days."
11091420|NCT01534663|FG001|Participant Flow|Glutamine/Fishoil|"3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d).~Glutamine and Fish Oil Supplementation: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days."
11091421|NCT01534663|OG000|Outcome|Placebo|"The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.~Placebo: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days."
11091422|NCT01534663|OG001|Outcome|Glutamine/Fishoil|"3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d).~Glutamine and Fish Oil Supplementation: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days."
11091423|NCT01534663|EG000|Reported Event|Placebo|"The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.~Placebo: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days."
11091424|NCT01534663|EG001|Reported Event|Glutamine/Fishoil|"3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d).~Glutamine and Fish Oil Supplementation: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days."
11091425|NCT01534689|BG000|Baseline|Erchonia FX-405™ Laser|"The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW~Erchonia FX-405™ Laser: The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time."
11091426|NCT01534689|FG000|Participant Flow|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
11091427|NCT01534689|OG000|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
11091428|NCT01534689|EG000|Reported Event|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
11091429|NCT01534897|BG000|Baseline|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
11091430|NCT01534897|FG000|Participant Flow|GSK2118436|"Note: This is a single arm feasibility study.~Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
11091431|NCT01534897|OG000|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
11091432|NCT01534897|OG000|Outcome|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
11091433|NCT01534897|EG000|Reported Event|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
11091434|NCT01534910|BG000|Baseline|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo"
11091435|NCT01534910|BG001|Baseline|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract"
11091436|NCT01534910|BG002|Baseline|Total|Total of all reporting groups
11091437|NCT01534910|FG000|Participant Flow|Sugar Pill|"placebo~placebo: placebo"
11091438|NCT01534910|FG001|Participant Flow|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day"
11091439|NCT01534910|OG000|Outcome|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo No adverse events"
11091440|NCT01534910|OG001|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
11091441|NCT01534910|OG000|Outcome|Sugar Pill|"placebo~placebo: placebo"
11091442|NCT01534910|OG001|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day"
11091443|NCT01534910|EG000|Reported Event|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo No adverse events"
11091444|NCT01534910|EG001|Reported Event|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
11091445|NCT01534962|BG000|Baseline|Ranolazine Low Dose|Ranolazine, low dose, oral, BID
11091446|NCT01534962|BG001|Baseline|Ranolazine Intermediate Dose|Ranolazine, intermediate dose, oral, BID
11091447|NCT01534962|BG002|Baseline|Ranolazin High Dose|Ranolazine, high dose, oral, BID
11091448|NCT01534962|BG003|Baseline|Placebo|Placebo, oral, BID.
11091449|NCT01534962|BG004|Baseline|Total|Total of all reporting groups
11091450|NCT01534962|FG000|Participant Flow|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091451|NCT01534962|FG001|Participant Flow|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091452|NCT01534962|FG002|Participant Flow|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091453|NCT01534962|FG003|Participant Flow|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
11091454|NCT01534962|OG000|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091455|NCT01534962|OG001|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091456|NCT01534962|OG002|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091457|NCT01534962|OG003|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
11091458|NCT01534962|EG000|Reported Event|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091459|NCT01534962|EG001|Reported Event|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091460|NCT01534962|EG002|Reported Event|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
11091461|NCT01534962|EG003|Reported Event|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
11091462|NCT01534975|BG000|Baseline|Iodixanol 320|"group 1 will receive iodixanol 320 as the contrast agent during CT acquisition. this will reflect the intervention of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography"
11091463|NCT01534975|BG001|Baseline|Iohexol 350|"group 2 will receive iohexol 350 as the contrast agent during CT acquisition. this will reflect the intervention of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography"
11091464|NCT01534975|BG002|Baseline|Iopamidol 370|"group 3 will receive iopamidol 370 as the contrast agent during CT acquisition. this will reflect the intervention of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography"
11091465|NCT01534975|BG003|Baseline|Iodixanol 270|"group 4 will receive iodixanol 270 as the contrast agent during CT acquisition. this will reflect the intervention of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography"
11091466|NCT01534975|BG004|Baseline|Total|Total of all reporting groups
11091467|NCT01534975|FG000|Participant Flow|Iodixanol 320|group 1 Iodixanol 320
11091468|NCT01534975|FG001|Participant Flow|Iohexol 350|group 2 iohexol 350
11091469|NCT01534975|FG002|Participant Flow|Iopamidol 370|group 3 iopamidol 370
11091470|NCT01534975|FG003|Participant Flow|Iodixanol 270|group 4 iodixanol 270
11091471|NCT01534975|OG000|Outcome|Iodixanol 320|group 1
11091472|NCT01534975|OG001|Outcome|Iohexol 350|group 2
11091473|NCT01534975|OG002|Outcome|Iopamidol 370|group 3
11091474|NCT01534975|OG003|Outcome|Iodixanol 270|group 4
11091475|NCT01534975|EG000|Reported Event|Iodixanol 320|group 1 iodixanol 320
11091476|NCT01534975|EG001|Reported Event|Iohexol 350|group 2 iohexol 350
11091477|NCT01534975|EG002|Reported Event|Iopamidol 370|group 3 iopamidol 370
11091478|NCT01534975|EG003|Reported Event|Iodixanol 270|group 4 iodixanol 270
11091479|NCT01535001|BG000|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
11091480|NCT01535001|BG001|Baseline|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
11091481|NCT01535001|BG002|Baseline|Total|Total of all reporting groups
11091482|NCT01535001|FG000|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
11091483|NCT01535001|FG001|Participant Flow|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
11091484|NCT01535001|OG000|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
10911253|NCT00616434|FG000|Participant Flow|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
10911254|NCT00616434|FG001|Participant Flow|Placebo|Placebo IM injection twice weekly for 12 weeks
10911255|NCT00616434|OG000|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
10911256|NCT00616434|OG001|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
10911257|NCT00616434|EG000|Reported Event|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
10911258|NCT00616434|EG001|Reported Event|Placebo|Placebo IM injection twice weekly for 12 weeks
10911259|NCT00616629|BG000|Baseline|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
10911260|NCT00616629|BG001|Baseline|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
10911261|NCT00616629|BG002|Baseline|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
10911262|NCT00616629|BG003|Baseline|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
10911263|NCT00616629|BG004|Baseline|Placebo|Corresponding placebo
11091485|NCT01535001|OG001|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
11091486|NCT01535001|EG000|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
11091487|NCT01535001|EG001|Reported Event|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
11091488|NCT01535014|BG000|Baseline|Dietressa 1|Dietressa: 1 tablet 6 times daily
11091489|NCT01535014|BG001|Baseline|Dietressa 2|Dietressa: 2 tablets 3 times daily
11091490|NCT01535014|BG002|Baseline|Placebo 3|Placebo: 1 tablet 6 times daily
11091491|NCT01535014|BG003|Baseline|Placebo 4|Placebo: 2 tablets 3 times daily
11091492|NCT01535014|BG004|Baseline|Total|Total of all reporting groups
11091493|NCT01535014|FG000|Participant Flow|Dietressa 1|Dietressa: 1 tablet 6 times daily
11091494|NCT01535014|FG001|Participant Flow|Dietressa 2|Dietressa: 2 tablets 3 times daily
11091495|NCT01535014|FG002|Participant Flow|Placebo 3|Placebo: 1 tablet 6 times daily
11173256|NCT02014480|FG002|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11173257|NCT02014480|FG003|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11173258|NCT02014480|FG004|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
11173259|NCT02014480|FG005|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
10911264|NCT00616629|BG005|Baseline|Total|Total of all reporting groups
11173260|NCT02014480|OG000|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11173261|NCT02014480|OG001|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11173262|NCT02014480|OG002|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11173263|NCT02014480|EG000|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11173264|NCT02014480|EG001|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11173265|NCT02014480|EG002|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
11173266|NCT02014519|BG000|Baseline|Study Group|Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
11173267|NCT02014519|FG000|Participant Flow|Study Group|Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
11173268|NCT02014519|OG000|Outcome|Study Group|Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
11173269|NCT02014519|OG000|Outcome|18-29 Years Group|Subjects, male and female, aged 18-29 years at the time of enrollment, who had agreed to collection of blood sample.
11173270|NCT02014519|OG001|Outcome|30-44 Years Group|Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.
11173271|NCT02014519|OG002|Outcome|45-59 Years Group|Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.
10911265|NCT00616629|FG000|Participant Flow|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
10911266|NCT00616629|FG001|Participant Flow|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
11173272|NCT02014519|OG003|Outcome|≥ 60 Years Group|Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
11173273|NCT02014519|OG000|Outcome|Female Group|Female subjects aged 18 years and above who had agreed to collection of blood sample.
11173274|NCT02014519|OG001|Outcome|Male Group|Male subjects aged 18 years and above who had agreed to collection of blood sample.
11173275|NCT02014519|OG000|Outcome|Male Group|Male subjects aged 18 years and above who had agreed to collection of blood sample.
11173276|NCT02014519|OG001|Outcome|Female Group|Female subjects aged 18 years and above who had agreed to collection of blood sample.
11173277|NCT02014519|EG000|Reported Event|Study Group|Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
11173278|NCT02014584|BG000|Baseline|Placebo|Participants received placebo administered orally once daily for 24 weeks.
11173279|NCT02014584|BG001|Baseline|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
11173280|NCT02014584|BG002|Baseline|Total|Total of all reporting groups
11173281|NCT02014584|FG000|Participant Flow|Placebo|Participants received placebo administered orally once daily for 24 weeks.
11173282|NCT02014584|FG001|Participant Flow|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
11173283|NCT02014584|FG002|Participant Flow|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
11173284|NCT02014584|FG003|Participant Flow|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
11173285|NCT02014584|FG004|Participant Flow|Targeted F/U: Placebo (DB)/Dutasteride 0.5 mg (OL)|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study treatment administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
11174271|NCT02020616|FG005|Participant Flow|200 mg LY3053102|200 mg LY3053102 administered SC Q1W for 12 weeks.
11173286|NCT02014584|FG005|Participant Flow|Targeted F/U: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study drug administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
11173287|NCT02014584|OG000|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
11173288|NCT02014584|OG001|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
10911267|NCT00616629|FG002|Participant Flow|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
10911268|NCT00616629|FG003|Participant Flow|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
10911269|NCT00616629|FG004|Participant Flow|Placebo|Corresponding placebo
10911270|NCT00616629|OG000|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
10911271|NCT00616629|OG001|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
10911272|NCT00616629|OG002|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
10911273|NCT00616629|OG003|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
10911274|NCT00616629|OG004|Outcome|Placebo|Corresponding placebo
10911275|NCT00616629|EG000|Reported Event|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
10911276|NCT00616629|EG001|Reported Event|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
10911277|NCT00616629|EG002|Reported Event|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
10911278|NCT00616629|EG003|Reported Event|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
10911279|NCT00616629|EG004|Reported Event|Placebo|Corresponding placebo
10911280|NCT00616655|BG000|Baseline|Placebo Arm|Placebo
10911281|NCT00616655|BG001|Baseline|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
10911282|NCT00616655|BG002|Baseline|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
10911283|NCT00616655|BG003|Baseline|Total|Total of all reporting groups
10911284|NCT00616655|FG000|Participant Flow|Placebo Arm|Placebo
10911285|NCT00616655|FG001|Participant Flow|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
10911286|NCT00616655|FG002|Participant Flow|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
10911287|NCT00616655|OG000|Outcome|Placebo Arm|Placebo
10911288|NCT00616655|OG001|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
10911289|NCT00616655|OG002|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
10911290|NCT00616655|EG000|Reported Event|Placebo Arm|Placebo
10911291|NCT00616655|EG001|Reported Event|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
10911292|NCT00616655|EG002|Reported Event|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
10911293|NCT00616772|BG000|Baseline|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
10911294|NCT00616772|BG001|Baseline|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
10911295|NCT00616772|BG002|Baseline|Total|Total of all reporting groups
10911296|NCT00616772|FG000|Participant Flow|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
10911297|NCT00616772|FG001|Participant Flow|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
10911298|NCT00616772|OG000|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
10911299|NCT00616772|OG001|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
10911300|NCT00616772|EG000|Reported Event|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
10911301|NCT00616772|EG001|Reported Event|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
10911302|NCT00616902|BG000|Baseline|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
10911303|NCT00616902|BG001|Baseline|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
10911304|NCT00616902|BG002|Baseline|Total|Total of all reporting groups
10911305|NCT00616902|FG000|Participant Flow|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
10911306|NCT00616902|FG001|Participant Flow|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
10911307|NCT00616902|OG000|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
10911308|NCT00616902|OG001|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
10911309|NCT00616902|EG000|Reported Event|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
10911310|NCT00616902|EG001|Reported Event|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
10915146|NCT00634166|FG001|Participant Flow|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
11091496|NCT01535014|FG003|Participant Flow|Placebo 4|Placebo: 2 tablets 3 times daily
11091497|NCT01535014|OG000|Outcome|Dietressa 1|Dietressa: 1 tablet 6 times daily
11091498|NCT01535014|OG001|Outcome|Dietressa 2|Dietressa: 2 tablets 3 times daily
11091499|NCT01535014|OG002|Outcome|Placebo 3|Placebo: 1 tablet 6 times daily
11091500|NCT01535014|OG003|Outcome|Placebo 4|Placebo: 2 tablets 3 times daily
11091501|NCT01535014|EG000|Reported Event|Dietressa 1+2|Dietressa 1: 1 tablet 6 times daily; Dietressa 2: 2 tablets 3 times daily
11091502|NCT01535014|EG001|Reported Event|Placebo 3+4|Placebo 3: 1 tablet 6 times daily; Placebo 4: 2 tablets 3 times daily
11091503|NCT01535040|BG000|Baseline|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
11091504|NCT01535040|BG001|Baseline|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
11091505|NCT01535040|BG002|Baseline|Total|Total of all reporting groups
11091506|NCT01535040|FG000|Participant Flow|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
11091507|NCT01535040|FG001|Participant Flow|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
11091508|NCT01535040|OG000|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
11091509|NCT01535040|OG001|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
11091510|NCT01535040|EG000|Reported Event|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
11091511|NCT01535040|EG001|Reported Event|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
11091512|NCT01535053|BG000|Baseline|Regimen I (Dactinomycin)|IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
11091513|NCT01535053|BG001|Baseline|Regimen II (Methotrexate)|"institutional preference of either:~IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR~IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days."
11091514|NCT01535053|BG002|Baseline|Total|Total of all reporting groups
11091515|NCT01535053|FG000|Participant Flow|Regimen I (Dactinomycin)|IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
11091516|NCT01535053|FG001|Participant Flow|Regimen II (Methotrexate)|"institutional preference of either:~IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR~IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days."
11091517|NCT01535053|OG000|Outcome|Regimen I (Dactinomycin)|IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
11091518|NCT01535053|OG001|Outcome|Regimen II (Methotrexate)|"institutional preference of either:~IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR~IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days."
11091519|NCT01535053|EG000|Reported Event|Regimen I (Dactinomycin)|IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
11091520|NCT01535053|EG001|Reported Event|Regimen II (Methotrexate)|"institutional preference of either:~IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR~IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days."
11091521|NCT01535118|BG000|Baseline|Adults and Children With ARC|Adults and children with ARC who complete the survey
11091522|NCT01535118|FG000|Participant Flow|Adults and Children With Allergic Rhinoconjunctivitis (ARC)|Adults and children with ARC who complete the survey
11091523|NCT01535118|OG000|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
11091524|NCT01535118|EG000|Reported Event|Adults and Children With ARC|Adults and children with ARC who complete the survey
11091525|NCT01535222|BG000|Baseline|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
11091526|NCT01535222|BG001|Baseline|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
11091527|NCT01535222|BG002|Baseline|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
11091528|NCT01535222|BG003|Baseline|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
11091529|NCT01535222|BG004|Baseline|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
11091530|NCT01535222|BG005|Baseline|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
11091531|NCT01535222|BG006|Baseline|Total|Total of all reporting groups
11091532|NCT01535222|FG000|Participant Flow|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
11091533|NCT01535222|FG001|Participant Flow|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
11091534|NCT01535222|FG002|Participant Flow|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
11091535|NCT01535222|FG003|Participant Flow|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
11091536|NCT01535222|FG004|Participant Flow|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
11173289|NCT02014584|OG000|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
10911311|NCT00616928|BG000|Baseline|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911312|NCT00616928|BG001|Baseline|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911313|NCT00616928|BG002|Baseline|Influenza A (H5N1) >64Y Group|Influenza A (H5N1) >64Y Group Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911314|NCT00616928|BG003|Baseline|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911315|NCT00616928|BG004|Baseline|Total|Total of all reporting groups
10911316|NCT00616928|FG000|Participant Flow|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911317|NCT00616928|FG001|Participant Flow|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911318|NCT00616928|FG002|Participant Flow|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911319|NCT00616928|FG003|Participant Flow|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911320|NCT00616928|OG000|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911321|NCT00616928|OG001|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911322|NCT00616928|OG002|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911323|NCT00616928|OG003|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911324|NCT00616928|OG000|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
10911325|NCT00616928|OG002|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911326|NCT00616928|OG004|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911327|NCT00616928|OG005|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911328|NCT00616928|OG000|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911329|NCT00616928|OG000|Outcome|Influenza A (H5N1) 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911330|NCT00616928|OG001|Outcome|Placebo 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
11233605|NCT02429778|FG000|Participant Flow|BREATHE|"4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks.~Diaphragmatic Breathing: Deep or diaphragmatic breathing is taught prior to relaxation.~Progressive Muscle Relaxation: Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety."
11233606|NCT02429778|FG001|Participant Flow|Wait List|8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested.
11233607|NCT02429778|OG000|Outcome|BREATHE|"4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks.~Diaphragmatic Breathing: Deep or diaphragmatic breathing is taught prior to relaxation.~Progressive Muscle Relaxation: Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety."
11233608|NCT02429778|OG001|Outcome|Wait List|8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested.
11233609|NCT02429778|EG000|Reported Event|BREATHE|"4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks.~Diaphragmatic Breathing: Deep or diaphragmatic breathing is taught prior to relaxation.~Progressive Muscle Relaxation: Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety."
11233610|NCT02429778|EG001|Reported Event|Wait List|8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested.
11233611|NCT02429856|BG000|Baseline|PCS Group|"SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants"
11233612|NCT02429856|BG001|Baseline|PCR Group|"SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants"
11233613|NCT02429856|BG002|Baseline|Total|Total of all reporting groups
11233614|NCT02429856|FG000|Participant Flow|PCS Group|"SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants"
11233615|NCT02429856|FG001|Participant Flow|PCR Group|"SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants"
11233616|NCT02429856|OG000|Outcome|PCS Group|"SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants"
11233617|NCT02429856|OG001|Outcome|PCR Group|"SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants"
11233618|NCT02429856|OG000|Outcome|PCS Group|"SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants"
11233619|NCT02429856|OG001|Outcome|PCR Group|"SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants"
11233620|NCT02429856|EG000|Reported Event|PCS Group|"SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants"
11233621|NCT02429856|EG001|Reported Event|PCR Group|"SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis~SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants"
11233622|NCT02429869|BG000|Baseline|Everolimus|Subjects on mTOR inhibitor (everolimus) for 6 months, added to standard of care immunosuppressive regimen
11233623|NCT02429869|FG000|Participant Flow|Everolimus|Subjects on mTOR inhibitor (everolimus) for 6 months, added to standard of care immunosuppressive regimen
11233624|NCT02429869|OG000|Outcome|Everolimus|This is a single arm study. Subjects on mTOR inhibitor (everolimus) for 6 months, added to standard of care immunosuppressive regimen
11233625|NCT02429869|EG000|Reported Event|Everolimus|Subjects on mTOR inhibitor (everolimus) for 6 months, added to standard of care immunosuppressive regimen
11233626|NCT02429934|BG000|Baseline|Abatacept|abatacept: 125mg injected subcutaneously weekly for 16 weeks
11233627|NCT02429934|BG001|Baseline|Placebo|Placebo subcutaneous injection weekly for 16 weeks
11233628|NCT02429934|BG002|Baseline|Total|Total of all reporting groups
11233629|NCT02429934|FG000|Participant Flow|Abatacept|abatacept: 125mg injected subcutaneously weekly for 16 weeks
11233630|NCT02429934|FG001|Participant Flow|Placebo|Placebo subcutaneous injection weekly for 16 weeks
11233631|NCT02429934|OG000|Outcome|Abatacept|abatacept: 125mg injected subcutaneously weekly for 16 weeks
11233632|NCT02429934|OG001|Outcome|Placebo|Placebo subcutaneous injection weekly for 16 weeks
11233633|NCT02429934|OG001|Outcome|Placebo|Placebo subcutaneous injections weekly for 16 weeks
11233634|NCT02429934|OG001|Outcome|Placebo|placebo injected subcutaneously weekly for 16 weeks
11233635|NCT02429934|EG000|Reported Event|Abatacept|abatacept: 125mg injected subcutaneously weekly for 16 weeks
11233636|NCT02429934|EG001|Reported Event|Placebo|Placebo subcutaneous injection weekly for 16 weeks
11342183|NCT03700385|FG000|Participant Flow|IOWA Approach Endocardial Ablation|"Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation.~IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System"
10911331|NCT00616928|OG002|Outcome|Influenza A (H5N1) >60Y Group|Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911332|NCT00616928|OG003|Outcome|Placebo >60Y Group|Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911333|NCT00616928|OG003|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911334|NCT00616928|OG003|Outcome|Placebo >64Y Group|Subjects aged >64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911335|NCT00616928|OG001|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911336|NCT00616928|EG000|Reported Event|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911337|NCT00616928|EG001|Reported Event|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911338|NCT00616928|EG002|Reported Event|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911339|NCT00616928|EG003|Reported Event|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
10911340|NCT00616941|BG000|Baseline|Cohort 1|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection."
10911341|NCT00616941|BG001|Baseline|Cohort 2|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection."
10911342|NCT00616941|BG002|Baseline|Cohort 3|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections."
10911343|NCT00616941|BG003|Baseline|Total|Total of all reporting groups
10911344|NCT00616941|FG000|Participant Flow|Cohort 1|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 overlapping peptides [OLP4]) once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of 5% dextrose in water (D5W) and administered subcutaneously as a single injection."
10911345|NCT00616941|FG001|Participant Flow|Cohort 2|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 vegetable grade (VG) once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection."
10911346|NCT00616941|FG002|Participant Flow|Cohort 3|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (poly-ICLC) once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections."
10911347|NCT00616941|OG000|Outcome|Cohort 1|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection."
10911348|NCT00616941|OG001|Outcome|Cohort 2|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection."
10911349|NCT00616941|OG002|Outcome|Cohort 3|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections."
10911350|NCT00616941|EG000|Reported Event|Cohort 1|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection."
11091537|NCT01535222|FG005|Participant Flow|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
11091538|NCT01535222|OG000|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
11091539|NCT01535222|OG001|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
11091540|NCT01535222|OG002|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
11091541|NCT01535222|OG003|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
11091542|NCT01535222|OG004|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
11091543|NCT01535222|OG005|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
11091544|NCT01535222|EG000|Reported Event|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
11091545|NCT01535222|EG001|Reported Event|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
11091546|NCT01535222|EG002|Reported Event|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
11091547|NCT01535222|EG003|Reported Event|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
11091548|NCT01535222|EG004|Reported Event|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
11091549|NCT01535222|EG005|Reported Event|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
11091550|NCT01535235|BG000|Baseline|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg Daily x 24 weeks"
11091551|NCT01535235|BG001|Baseline|Placebo|"Placebo group~Placebo: Placebo Daily x24wks"
11091552|NCT01535235|BG002|Baseline|Total|Total of all reporting groups
11091553|NCT01535235|FG000|Participant Flow|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
11091554|NCT01535235|FG001|Participant Flow|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
11091555|NCT01535235|OG000|Outcome|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
11091556|NCT01535235|OG001|Outcome|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
11091557|NCT01535235|EG000|Reported Event|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
11091558|NCT01535235|EG001|Reported Event|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
11091559|NCT01535261|BG000|Baseline|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
11091560|NCT01535261|FG000|Participant Flow|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
11091561|NCT01535261|OG000|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
11091562|NCT01535261|EG000|Reported Event|Ranibizumab 0.5mg|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
11091563|NCT01535287|BG000|Baseline|Dexmedetomidine|"Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.~Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
11091564|NCT01535287|BG001|Baseline|Placebo|"Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.~Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
11091565|NCT01535287|BG002|Baseline|Total|Total of all reporting groups
11091566|NCT01535287|FG000|Participant Flow|Dexmedetomidine|"Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.~Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
11091567|NCT01535287|FG001|Participant Flow|Placebo|"Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.~Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
11091568|NCT01535287|OG000|Outcome|Dexmedetomidine|"Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.~Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
11091569|NCT01535287|OG001|Outcome|Placebo|"Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.~Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
11174272|NCT02020616|FG006|Participant Flow|2 mg Exenatide ER|2 mg exenatide ER administered SC Q1W for 12 weeks.
11174273|NCT02020616|OG000|Outcome|Placebo|Placebo administered SC Q1W for 12 weeks
11174274|NCT02020616|OG001|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC Q1W for 12 weeks
11174275|NCT02020616|OG002|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC Q1W for 12 weeks
11091570|NCT01535287|EG000|Reported Event|Dexmedetomidine|"Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.~Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
11091571|NCT01535287|EG001|Reported Event|Placebo|"Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.~Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
11091572|NCT01535326|BG000|Baseline|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
11091573|NCT01535326|BG001|Baseline|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
11091574|NCT01535326|BG002|Baseline|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
11091575|NCT01535326|BG003|Baseline|Total|Total of all reporting groups
11091576|NCT01535326|FG000|Participant Flow|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
11091577|NCT01535326|FG001|Participant Flow|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
11091578|NCT01535326|FG002|Participant Flow|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
11091579|NCT01535326|OG000|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy~Proportion of no pain: 30%"
11091580|NCT01535326|OG001|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal~Proportion of no pain: 43.3%"
11091581|NCT01535326|OG002|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy~Proportion of no pain: 61.1%"
11091582|NCT01535326|OG000|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
11091583|NCT01535326|OG001|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
11091584|NCT01535326|OG002|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
11091585|NCT01535326|EG000|Reported Event|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
11091586|NCT01535326|EG001|Reported Event|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
11091587|NCT01535326|EG002|Reported Event|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
11091588|NCT01535365|BG000|Baseline|Heat|Application of Heat to site of muscle sprain.
11091589|NCT01535365|BG001|Baseline|Cold|Application of cold to muscle sprain.
11091590|NCT01535365|BG002|Baseline|Total|Total of all reporting groups
11091591|NCT01535365|FG000|Participant Flow|Heat|Application of Heat to site of muscle sprain.
11091592|NCT01535365|FG001|Participant Flow|Cold|Application of cold to muscle sprain.
11091593|NCT01535365|OG000|Outcome|Heat Pack|Application of Heat to site of muscle sprain.
11091594|NCT01535365|OG001|Outcome|Ice Pack|Application of cold to muscle sprain.
11091595|NCT01535365|OG000|Outcome|Heat|Application of heat to site of muscle sprain.
11091596|NCT01535365|OG001|Outcome|Cold|Application of cold to muscle sprain.
11091597|NCT01535365|EG000|Reported Event|Heat|Application of Heat to site of muscle sprain.
11091598|NCT01535365|EG001|Reported Event|Cold|Application of cold to muscle sprain.
11091599|NCT01535443|BG000|Baseline|PRO-155 Ophthalmic Solution 0.09 %|PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..
11091600|NCT01535443|FG000|Participant Flow|PRO-155 Ophthalmic Solution 0.09 %|PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
11091601|NCT01535443|OG000|Outcome|PRO-155 Ophthalmic Solution 0.09 %|PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
11091602|NCT01535443|OG000|Outcome|PRO-155 Ophthalmic Solution 0.09 %|PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..
11091603|NCT01535443|EG000|Reported Event|PRO-155 Ophthalmic Solution 0.09 %|PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..
11091604|NCT01535560|BG000|Baseline|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
11091605|NCT01535560|BG001|Baseline|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
11091606|NCT01535560|BG002|Baseline|Total|Total of all reporting groups
11091607|NCT01535560|FG000|Participant Flow|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
11091608|NCT01535560|FG001|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
11091609|NCT01535560|OG000|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
11091610|NCT01535560|OG001|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
11091611|NCT01535560|EG000|Reported Event|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
11091612|NCT01535560|EG001|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
11091613|NCT01535573|BG000|Baseline|Citalopram Low Dose|"Citalopram 20 mg~Citalopram: 20 mg once per day for 9 weeks"
11091614|NCT01535573|BG001|Baseline|Citalopram High Dose|"Citalopram 40 mg~Citalopram: 40 mg per day for 9 weeks"
11091615|NCT01535573|BG002|Baseline|Placebo|"Placebo~Placebo: 0 mg per day for 9 weeks"
11091616|NCT01535573|BG003|Baseline|Total|Total of all reporting groups
11091617|NCT01535573|FG000|Participant Flow|Citalopram Low Dose|"Citalopram 20 mg~Citalopram: 20 mg once per day for 9 weeks"
11174276|NCT02020616|OG003|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC Q1W for 12 weeks
11174277|NCT02020616|OG004|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC Q1W for 12 weeks
11091618|NCT01535573|FG001|Participant Flow|Citalopram High Dose|"Citalopram 40 mg~Citalopram: 40 mg per day for 9 weeks"
11091619|NCT01535573|FG002|Participant Flow|Placebo|"Placebo~Placebo: 0 mg per day for 9 weeks"
11091620|NCT01535573|OG000|Outcome|Citalopram Low Dose|"Citalopram 20 mg~Citalopram: 20 mg once per day for 9 weeks"
11091621|NCT01535573|OG001|Outcome|Citalopram High Dose|"Citalopram 40 mg~Citalopram: 40 mg per day for 9 weeks"
11091622|NCT01535573|OG002|Outcome|Placebo|"Placebo~Placebo: 0 mg per day for 9 weeks"
11091623|NCT01535573|EG000|Reported Event|Citalopram Low Dose|"Citalopram 20 mg~Citalopram: 20 mg once per day for 9 weeks"
11091624|NCT01535573|EG001|Reported Event|Citalopram High Dose|"Citalopram 40 mg~Citalopram: 40 mg per day for 9 weeks"
11091625|NCT01535573|EG002|Reported Event|Placebo|"Placebo~Placebo: 0 mg per day for 9 weeks"
11091626|NCT01535599|BG000|Baseline|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
11091627|NCT01535599|BG001|Baseline|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
11091628|NCT01535599|BG002|Baseline|Total|Total of all reporting groups
11091629|NCT01535599|FG000|Participant Flow|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
11091630|NCT01535599|FG001|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
11091631|NCT01535599|OG000|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
11091632|NCT01535599|OG001|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
11091633|NCT01535599|EG000|Reported Event|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
11091634|NCT01535599|EG001|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
11091635|NCT01535638|BG000|Baseline|All Subjects|This study was conducted in healthy male subjects as open-label, single-dose, randomised three-way crossover trial to investigate relative bioavailability. Each subject was planned to receive all 3 treatments in a randomly assigned order. The treatments were 3 single doses of 600 mg (3 film-coated tablets à 200 mg each) of Deleobuvir, either as TF II (trial formulation 2) formulation, FF (final formulation) formulation or as FF modified formulation.
11091636|NCT01535638|FG000|Participant Flow|Trial Formulation II / Final Formulation (FF) / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation (TF) II, Final Formulation (FF) and FF modified. There was a wash out period of at least 6 days between each drug administration.
11091637|NCT01535638|FG001|Participant Flow|Trial Formulation II / Final Formulation (FF) Modified / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation II, Final Formulation modified and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
11091638|NCT01535638|FG002|Participant Flow|Final Formulation (FF) / Trial Formulation II / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Trial Formulation II and Final Formulation modified. There was a wash out period of at least 6 days between each drug administration.
11091639|NCT01535638|FG003|Participant Flow|Final Formulation (FF) / FF Modified / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Final Formulation modified and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
11091640|NCT01535638|FG004|Participant Flow|Final Formulation (FF) Modified / Trial Formulation II / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Trial Formulation II and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
11091641|NCT01535638|FG005|Participant Flow|Final Formulation (FF) Modified / FF / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Final Formulation and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
11091642|NCT01535638|OG000|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
11091643|NCT01535638|OG001|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
11091644|NCT01535638|OG002|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
11091645|NCT01535638|EG000|Reported Event|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
11091646|NCT01535638|EG001|Reported Event|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
10911351|NCT00616941|EG001|Reported Event|Cohort 2|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection."
10911352|NCT00616941|EG002|Reported Event|Cohort 3|"Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.~1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections."
10911353|NCT00617058|BG000|Baseline|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
10911354|NCT00617058|BG001|Baseline|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
10911355|NCT00617058|BG002|Baseline|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
10911356|NCT00617058|BG003|Baseline|Total|Total of all reporting groups
10911357|NCT00617058|FG000|Participant Flow|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
10911358|NCT00617058|FG001|Participant Flow|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
10911359|NCT00617058|FG002|Participant Flow|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
10911360|NCT00617058|OG000|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
10911361|NCT00617058|OG001|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
10911362|NCT00617058|OG002|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
10911363|NCT00617058|EG000|Reported Event|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
10911364|NCT00617058|EG001|Reported Event|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
10911365|NCT00617058|EG002|Reported Event|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
10911366|NCT00617084|BG000|Baseline|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
10911367|NCT00617084|BG001|Baseline|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
10911368|NCT00617084|BG002|Baseline|Total|Total of all reporting groups
10911369|NCT00617084|FG000|Participant Flow|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
10911370|NCT00617084|FG001|Participant Flow|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
10911371|NCT00617084|OG000|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
10911372|NCT00617084|OG001|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
10911373|NCT00617084|EG000|Reported Event|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
10911374|NCT00617084|EG001|Reported Event|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
10911375|NCT00617097|BG000|Baseline|Paracervical Block With Lidocaine|Subjects who received pain control with paracervical block with 18mL of 1% lidocaine and 2mL of saline during first trimester surgical abortion
10911376|NCT00617097|BG001|Baseline|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control with paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
10911377|NCT00617097|BG002|Baseline|Total|Total of all reporting groups
10911378|NCT00617097|FG000|Participant Flow|Paracervical Block With Lidocaine|Subjects who received paracervical block with 18 mL of 1% lidocaine and 2 mL of saline for pain control during first trimester surgical abortion
10911379|NCT00617097|FG001|Participant Flow|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control of paracervical block with combined 30mg of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
10911380|NCT00617097|OG000|Outcome|Paracervical Block With Lidocaine|Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
10911381|NCT00617097|OG001|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
10911382|NCT00617097|OG000|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
10911383|NCT00617097|OG001|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
10911384|NCT00617097|EG000|Reported Event|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
10911385|NCT00617097|EG001|Reported Event|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
10911386|NCT00617123|BG000|Baseline|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
10911387|NCT00617123|BG001|Baseline|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
10911388|NCT00617123|BG002|Baseline|Total|Total of all reporting groups
10911389|NCT00617123|FG000|Participant Flow|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
10911390|NCT00617123|FG001|Participant Flow|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
10911391|NCT00617123|OG000|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
10911392|NCT00617123|OG001|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
10911393|NCT00617123|EG000|Reported Event|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
10911394|NCT00617123|EG001|Reported Event|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
10911395|NCT00617175|BG000|Baseline|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
10911396|NCT00617175|BG001|Baseline|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
10911397|NCT00617175|BG002|Baseline|Total|Total of all reporting groups
10911398|NCT00617175|FG000|Participant Flow|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
10911399|NCT00617175|FG001|Participant Flow|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
10911400|NCT00617175|OG000|Outcome|NID 18/24|standard number of interval to detect ventricular arrhythmias
10911401|NCT00617175|OG001|Outcome|NID 30/40|Prolonged number of interval to detect ventricular arrhythmias
10911402|NCT00617175|EG000|Reported Event|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
10911403|NCT00617175|EG001|Reported Event|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
10911404|NCT00617188|BG000|Baseline|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
10911405|NCT00617188|FG000|Participant Flow|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
10911406|NCT00617188|OG000|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
10911407|NCT00617188|EG000|Reported Event|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
10911408|NCT00617201|BG000|Baseline|Placebo|Matched placebo
10911409|NCT00617201|BG001|Baseline|Atomoxetine|Atomoxetine (80 mg/day)
10911410|NCT00617201|BG002|Baseline|Total|Total of all reporting groups
10911411|NCT00617201|FG000|Participant Flow|Atomoxetine (80 mg/Day)|"Active drug~atomoxetine : Once daily oral dosing"
10911412|NCT00617201|FG001|Participant Flow|Matched Placebo|"Matched Placebo~placebo : Once daily oral dosing - matched placebo"
10911413|NCT00617201|OG000|Outcome|Placebo|Matched Placebo
10911414|NCT00617201|OG001|Outcome|Atomoxetine|80 mg/day (after intial 4-day run up)
10911415|NCT00617201|OG000|Outcome|Placebo|Matched placebo
10911416|NCT00617201|OG001|Outcome|Atomoxetine|Atomoxetine (80 mg/day)
10911417|NCT00617201|EG000|Reported Event|Atomoxetine (80 mg/Day)|"Active drug~atomoxetine : Once daily oral dosing"
10911418|NCT00617201|EG001|Reported Event|Matched Placebo|"Matched Placebo~placebo : Once daily oral dosing - matched placebo"
10911419|NCT00617240|BG000|Baseline|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
10911420|NCT00617240|BG001|Baseline|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
10911421|NCT00617240|BG002|Baseline|Total|Total of all reporting groups
10911422|NCT00617240|FG000|Participant Flow|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
10911423|NCT00617240|FG001|Participant Flow|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
10911424|NCT00617240|OG000|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
10911425|NCT00617240|OG001|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
10911426|NCT00617240|EG000|Reported Event|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
10911427|NCT00617240|EG001|Reported Event|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
10911428|NCT00617279|BG000|Baseline|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
11174278|NCT02020616|OG005|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC Q1W for 12 weeks
10911429|NCT00617279|BG001|Baseline|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
10911430|NCT00617279|BG002|Baseline|Total|Total of all reporting groups
10911431|NCT00617279|FG000|Participant Flow|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
10911432|NCT00617279|FG001|Participant Flow|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
10911433|NCT00617279|OG000|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
10911434|NCT00617279|OG001|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
10911435|NCT00617279|EG000|Reported Event|GORE PROPATEN Vascular Graft|GORE PROPATEN Vascular Graft
10911436|NCT00617279|EG001|Reported Event|Disadvantaged Autologous Vein Graft|Disadvantaged Autologous Vein Graft
10911437|NCT00617305|BG000|Baseline|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
10911438|NCT00617305|BG001|Baseline|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
10911439|NCT00617305|BG002|Baseline|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
10911440|NCT00617305|BG003|Baseline|Total|Total of all reporting groups
10911441|NCT00617305|FG000|Participant Flow|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
11173290|NCT02014584|OG001|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
10911442|NCT00617305|FG001|Participant Flow|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
10911443|NCT00617305|FG002|Participant Flow|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
10911444|NCT00617305|OG000|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
10911445|NCT00617305|OG001|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
10911446|NCT00617305|OG002|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
10911447|NCT00617305|OG003|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
10911448|NCT00617305|OG004|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
10911449|NCT00617305|OG001|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
10911450|NCT00617305|EG000|Reported Event|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
10911451|NCT00617305|EG001|Reported Event|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i
10911452|NCT00617305|EG002|Reported Event|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
11174279|NCT02020616|OG006|Outcome|2 mg Exenatide ER|2 mg Exenatide ER administered SC Q1W for 12 weeks
11174280|NCT02020616|OG000|Outcome|Placebo|Placebo administered SC QW for 12 weeks
10911453|NCT00617344|BG000|Baseline|CYD Dengue Vaccine 5555 Formulation|Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911454|NCT00617344|BG001|Baseline|CYD Dengue Vaccine 5553 Formulation|Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911455|NCT00617344|BG002|Baseline|CYD Dengue Vaccine 4444 Formulation|Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911456|NCT00617344|BG003|Baseline|Total|Total of all reporting groups
10911457|NCT00617344|FG000|Participant Flow|CYD Dengue Vaccine 5555 Formulation|Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911458|NCT00617344|FG001|Participant Flow|CYD Dengue Vaccine 5553 Formulation|Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911459|NCT00617344|FG002|Participant Flow|CYD Dengue Vaccine 4444 Formulation|Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911460|NCT00617344|OG000|Outcome|CYD Dengue Vaccine 5555 Formulation|Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911461|NCT00617344|OG001|Outcome|CYD Dengue Vaccine 5553 Formulation|Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911462|NCT00617344|OG002|Outcome|CYD Dengue Vaccine 4444 Formulation|Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911463|NCT00617344|EG000|Reported Event|CYD Dengue Vaccine 5555 Formulation|Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911464|NCT00617344|EG001|Reported Event|CYD Dengue Vaccine 5553 Formulation|Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911465|NCT00617344|EG002|Reported Event|CYD Dengue Vaccine 4444 Formulation|Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
10911466|NCT00617357|BG000|Baseline|One Arm|Strattice Reconstructive Tissue Matrix
10911467|NCT00617357|FG000|Participant Flow|Strattice Tissue Matrix|
10911468|NCT00617357|OG000|Outcome|One Arm|Strattice Reconstructive Tissue Matrix
10911469|NCT00617357|OG000|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
10911470|NCT00617357|EG000|Reported Event|Strattice|
10911471|NCT00617396|BG000|Baseline|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total) 25 subjects were enrolled in this group.
10911472|NCT00617396|FG000|Participant Flow|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. 25 subjects were enrolled in this group.
10911473|NCT00617396|OG000|Outcome|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)30 subjects were enrolled in this group.
10911474|NCT00617396|EG000|Reported Event|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose Quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)29 subjects were enrolled in this group.
10911475|NCT00617409|BG000|Baseline|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
10911476|NCT00617409|BG001|Baseline|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
10911477|NCT00617409|BG002|Baseline|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
10911478|NCT00617409|BG003|Baseline|Total|Total of all reporting groups
10911479|NCT00617409|FG000|Participant Flow|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
10911480|NCT00617409|FG001|Participant Flow|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
10911481|NCT00617409|FG002|Participant Flow|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
10911482|NCT00617409|OG000|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
10911483|NCT00617409|OG001|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
10911484|NCT00617409|OG002|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
10911485|NCT00617409|OG002|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
10911486|NCT00617409|EG000|Reported Event|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
10911487|NCT00617409|EG001|Reported Event|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
10911488|NCT00617409|EG002|Reported Event|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
10911489|NCT00617461|BG000|Baseline|All Participants in the Intent-to-Treat Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment, summarized independent of treatment sequence.
10911490|NCT00617461|FG000|Participant Flow|GEn 1200 mg/Day Followed by GEn 3600 mg/Day|Gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, 1200 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 3600 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 1200 mg/day for 3 days, followed by 600 mg/ day for 3 days.
10911491|NCT00617461|FG001|Participant Flow|GEn 3600 mg/Day Followed by GEn 1200 mg/Day|GEn 3600 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 1200 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days.
10911492|NCT00617461|OG000|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
10911493|NCT00617461|OG001|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
10911494|NCT00617461|OG000|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period only
10911495|NCT00617461|OG001|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period only
10911496|NCT00617461|OG002|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period only
10911497|NCT00617461|OG003|Outcome|GEn 3600 mg in Second Interevention Period|GEn 3600 mg daily in second intervention period only
10911498|NCT00617461|OG000|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
10911499|NCT00617461|OG001|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
10911500|NCT00617461|OG002|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
10911501|NCT00617461|OG003|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
10911502|NCT00617461|OG003|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily either in second intervention period
10911503|NCT00617461|OG000|Outcome|GEn 1200 mg|PK population from GEn 1200 mg treatment daily from either first intervention period or second intervention period
10911504|NCT00617461|OG001|Outcome|GEn 3600 mg|PK population from GEn 3600 mg treatment daily from either first intervention period or second intervention period
10911505|NCT00617461|OG002|Outcome|Gabapentin 1800 mg|PK population from Gabapentin 1800 mg Baseline Treatment period
10911506|NCT00617461|EG000|Reported Event|Baseline Gabapentin 1800 mg|Gabapentin 1800 mg daily for 2 weeks before randomization. Only includes participants who were subsequently randomized.
10911507|NCT00617461|EG001|Reported Event|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
10911508|NCT00617461|EG002|Reported Event|Crossover GEn 2400 mg|GEn 2400 mg daily during 4-day crossover period in between the first intervention period and the second intervention period
10911509|NCT00617461|EG003|Reported Event|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
10911510|NCT00617461|EG004|Reported Event|Down-Titration Period|Participants down- titrated from GEn 3600 mg/day by taking 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days before ending the assigned treatment. Participants down- titrated from GEn 1200 mg/day by taking 1200 mg/day for 3 days, followed by 600 mg/day for 3 days before ending the assigned treatment.
10911511|NCT00617461|EG005|Reported Event|Overall GEn|All participants receiving GEn in any treatment period
10911512|NCT00617539|BG000|Baseline|Irinotecan and Temozolomide|125 mg/m^2 irinotecan hydrochloride administered intravenously on days 1 and 15 of a 28 day cycle 100 mg/m^2 temozolomide orally for seven days on days 1-7 and days 15-21 of a 28 day cycle
10911513|NCT00617539|FG000|Participant Flow|Irinotecan and Temozolomide|"125 mg/m^2 irinotecan hydrochloride administered intravenously on days 1 and 15 of a 28 day cycle~100 mg/m^2 temozolomide orally for seven days on days 1-7 and days 15-21 of a 28 day cycle"
10911514|NCT00617539|OG000|Outcome|Irinotecan and Temozolomide|"irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle~temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle"
10911515|NCT00617539|OG000|Outcome|Irinotecan and Temozolomide|"irinotecan hydrochloride administered intravenously at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle~temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle"
10911516|NCT00617539|EG000|Reported Event|Irinotecan and Temozolomide|irinotecan hydrochloride administered intravenously at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle, and temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 every 28 days.
10911517|NCT00617591|BG000|Baseline|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
10911518|NCT00617591|FG000|Participant Flow|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
10911519|NCT00617591|OG000|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
11173291|NCT02014584|OG000|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
11173292|NCT02014584|EG000|Reported Event|Placebo (DB)|
10911520|NCT00617591|OG000|Outcome|Induction at Initial Full Dose|"Induction Phase for First 29 Participants~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1."
10911521|NCT00617591|EG000|Reported Event|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
10911522|NCT00617604|BG000|Baseline|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
10911523|NCT00617604|BG001|Baseline|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
10911524|NCT00617604|BG002|Baseline|Total|Total of all reporting groups
10911525|NCT00617604|FG000|Participant Flow|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
10911526|NCT00617604|FG001|Participant Flow|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
10911527|NCT00617604|OG000|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
10911528|NCT00617604|OG001|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
10911529|NCT00617604|EG000|Reported Event|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
10911530|NCT00617604|EG001|Reported Event|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
10911531|NCT00617669|BG000|Baseline|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
10911532|NCT00617669|BG001|Baseline|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
10911533|NCT00617669|BG002|Baseline|Total|Total of all reporting groups
10911534|NCT00617669|FG000|Participant Flow|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
10911535|NCT00617669|FG001|Participant Flow|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
10911536|NCT00617669|OG000|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
10911537|NCT00617669|OG001|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
10911538|NCT00617669|EG000|Reported Event|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
10911539|NCT00617669|EG001|Reported Event|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
10911540|NCT00617734|BG000|Baseline|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10911541|NCT00617734|BG001|Baseline|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10911542|NCT00617734|BG002|Baseline|Total|Total of all reporting groups
10911543|NCT00617734|FG000|Participant Flow|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 milligrams per kilogram (mg/kg) dose administered as an intravenous (IV) infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy. (4-week cycle). Treatment was continued until there was evidence of progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
10911544|NCT00617734|FG001|Participant Flow|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 milligrams per square meter (mg/m^2) administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10911545|NCT00617734|OG000|Outcome|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
11173293|NCT02014584|EG001|Reported Event|Dutasteride 0.5 mg (DB)|
11173294|NCT02014584|EG002|Reported Event|Placebo (DB)/Dutasteride 0.5 mg (OL)|
11173295|NCT02014584|EG003|Reported Event|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|
11173296|NCT02014584|EG004|Reported Event|Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|
10911546|NCT00617734|OG001|Outcome|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10911547|NCT00617734|EG000|Reported Event|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10911548|NCT00617734|EG001|Reported Event|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
10911549|NCT00617773|BG000|Baseline|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
10911550|NCT00617773|FG000|Participant Flow|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
10911551|NCT00617773|OG000|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
10911552|NCT00617773|EG000|Reported Event|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
10911553|NCT00617851|BG000|Baseline|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
10911554|NCT00617851|BG001|Baseline|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
10911555|NCT00617851|BG002|Baseline|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
10911556|NCT00617851|BG003|Baseline|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
10911557|NCT00617851|BG004|Baseline|Total|Total of all reporting groups
10911558|NCT00617851|FG000|Participant Flow|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influeza virus vaccine
10911559|NCT00617851|FG001|Participant Flow|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influeza virus vaccine
10911560|NCT00617851|FG002|Participant Flow|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influeza virus vaccine
10911561|NCT00617851|FG003|Participant Flow|Comparator Influenza Vaccine|One injection of the comparator influeza virus vaccine
10911562|NCT00617851|OG000|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
10911563|NCT00617851|OG001|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
10911564|NCT00617851|OG002|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
10911565|NCT00617851|OG000|Outcome|Influenza Virus Vaccine (Strain A/H1N1)|One injection of the investigational influenza virus vaccine-Strain A/H1N1
10911566|NCT00617851|OG001|Outcome|Influenza Virus Vaccine (Strain A/H3N2)|One injection of the investigational influenza virus vaccine-Strain A/H3N2
10911567|NCT00617851|OG002|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine-Strain B
10911568|NCT00617851|OG003|Outcome|Comparator Influenza Vaccine (Strain A/H1N1)|One injection of the comparator influenza virus vaccine-Strain A/H1N1
10911569|NCT00617851|OG004|Outcome|Comparator Influenza Vaccine (Strain A/H3N2)|One injection of the comparator influenza virus vaccine-Strain A/H3N2
10911570|NCT00617851|OG005|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza virus vaccine-Strain B
10911571|NCT00617851|OG003|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
10911572|NCT00617851|OG004|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
10911573|NCT00617851|OG000|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
10911574|NCT00617851|OG001|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
10911575|NCT00617851|OG002|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
10911576|NCT00617851|OG003|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
10911577|NCT00617851|OG004|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
10911578|NCT00617851|EG000|Reported Event|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
10911579|NCT00617851|EG001|Reported Event|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
10911580|NCT00617890|BG000|Baseline|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
10911581|NCT00617890|BG001|Baseline|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
10911582|NCT00617890|BG002|Baseline|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
11173297|NCT02014597|BG000|Baseline|Normal|Normal subjects without glaucoma
11173298|NCT02014597|BG001|Baseline|Glaucoma|Subjects with glaucoma
10911583|NCT00617890|BG003|Baseline|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
10911584|NCT00617890|BG004|Baseline|Total|Total of all reporting groups
10911585|NCT00617890|FG000|Participant Flow|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
10911586|NCT00617890|FG001|Participant Flow|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
10911587|NCT00617890|FG002|Participant Flow|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
10911588|NCT00617890|FG003|Participant Flow|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
10911589|NCT00617890|OG000|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
10911590|NCT00617890|OG000|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
10911591|NCT00617890|OG001|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
11173299|NCT02014597|BG002|Baseline|Total|Total of all reporting groups
10911592|NCT00617890|OG000|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
10911593|NCT00617890|OG002|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
10911594|NCT00617890|OG003|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
10911595|NCT00617890|OG001|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
10911596|NCT00617890|EG000|Reported Event|Group 1: 0.3mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
11091647|NCT01535638|EG002|Reported Event|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
11091648|NCT01535638|EG003|Reported Event|Deleobuvir (Total)|All subjects while on treatment with Deleobuvir, i.e. there is no distinction between the 3 formulations.
11091649|NCT01535664|BG000|Baseline|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
11091650|NCT01535664|FG000|Participant Flow|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
11091651|NCT01535664|OG000|Outcome|Dalfampridine-ER Withdrawn|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
11091652|NCT01535664|OG001|Outcome|Dalfampridine-ER 10 mg|
11091653|NCT01535664|OG000|Outcome|Dalfampridine-ER Withdrawn|
10911597|NCT00617890|EG001|Reported Event|Group 1: 10mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
10911598|NCT00617890|EG002|Reported Event|Group 2: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
10911599|NCT00617890|EG003|Reported Event|Group 3: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
10911600|NCT00617903|BG000|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
10911601|NCT00617903|BG001|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
10911602|NCT00617903|BG002|Baseline|Total|Total of all reporting groups
10911603|NCT00617903|FG000|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
10911604|NCT00617903|FG001|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
10911605|NCT00617903|OG000|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
10911606|NCT00617903|OG001|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
10911607|NCT00617903|EG000|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
10911608|NCT00617903|EG001|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
10911609|NCT00617929|BG000|Baseline|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
10911610|NCT00617929|FG000|Participant Flow|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
10911611|NCT00617929|OG000|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
10911612|NCT00617929|EG000|Reported Event|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
10911613|NCT00617942|BG000|Baseline|Cohort 1|
10911614|NCT00617942|BG001|Baseline|Cohort 2|
10911615|NCT00617942|BG002|Baseline|Total|Total of all reporting groups
10911616|NCT00617942|FG000|Participant Flow|Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16~Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians"
10911617|NCT00617942|FG001|Participant Flow|Cohort 2|"Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16~Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians"
10911618|NCT00617942|OG000|Outcome|Cohort 1|
10911619|NCT00617942|OG001|Outcome|Cohort 2|
10911620|NCT00617942|OG000|Outcome|Neo-adjuvant Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16"
10911621|NCT00617942|OG001|Outcome|Neo-adjuvant Cohort 2|Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
10911622|NCT00617942|OG002|Outcome|Adjuvant Cohort 1|Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
10911623|NCT00617942|OG003|Outcome|Adjuvant Cohort 2|Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
11173300|NCT02014597|FG000|Participant Flow|Normal|Normal subjects without glaucoma
11173301|NCT02014597|FG001|Participant Flow|Glaucoma|Subjects with glaucoma
11173302|NCT02014597|OG000|Outcome|Normal|Normal subjects without glaucoma
10911624|NCT00617942|EG000|Reported Event|Neo-adjuvant Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16"
10911625|NCT00617942|EG001|Reported Event|Neo-adjuvant Cohort 2|Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
10911626|NCT00617942|EG002|Reported Event|Adjuvant Cohort 1|Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
10911627|NCT00617942|EG003|Reported Event|Adjuvant Cohort 2|Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
10911628|NCT00617981|BG000|Baseline|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
10911629|NCT00617981|BG001|Baseline|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
10911630|NCT00617981|BG002|Baseline|Total|Total of all reporting groups
10911631|NCT00617981|FG000|Participant Flow|ThermoDox + RFA|"ThermoDox should be administered at 50 mg/m2. The infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
10911632|NCT00617981|FG001|Participant Flow|Sham + RFA|"Sham infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.~5% Dextrose Solution: Single 30 minute intravenous infusion"
10911633|NCT00617981|OG000|Outcome|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
10911634|NCT00617981|OG001|Outcome|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
10911635|NCT00617981|EG000|Reported Event|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
10911636|NCT00617981|EG001|Reported Event|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
10911637|NCT00618072|BG000|Baseline|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
10911638|NCT00618072|BG001|Baseline|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
10911639|NCT00618072|BG002|Baseline|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
10911640|NCT00618072|BG003|Baseline|Total|Total of all reporting groups
10911641|NCT00618072|FG000|Participant Flow|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
10911642|NCT00618072|FG001|Participant Flow|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
10911643|NCT00618072|FG002|Participant Flow|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
10911644|NCT00618072|OG000|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
10911645|NCT00618072|OG001|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
10911646|NCT00618072|OG002|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
10911647|NCT00618072|EG000|Reported Event|A: EMPOWIR and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
11173303|NCT02014597|OG001|Outcome|Glaucoma|Subjects with glaucoma
10911648|NCT00618072|EG001|Reported Event|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone placebo 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
10911649|NCT00618072|EG002|Reported Event|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
10911650|NCT00618332|BG000|Baseline|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
10911651|NCT00618332|BG001|Baseline|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
10911652|NCT00618332|BG002|Baseline|Total|Total of all reporting groups
10911653|NCT00618332|FG000|Participant Flow|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
10911654|NCT00618332|FG001|Participant Flow|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
10911655|NCT00618332|OG000|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
10911656|NCT00618332|OG001|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
10911657|NCT00618332|EG000|Reported Event|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
11173304|NCT02014597|EG000|Reported Event|Normal|Normal subjects without glaucoma
11173305|NCT02014597|EG001|Reported Event|Glaucoma|Subjects with glaucoma
11173306|NCT02014740|BG000|Baseline|Liraglutide|• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
10911658|NCT00618332|EG001|Reported Event|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
11173307|NCT02014740|BG001|Baseline|Metformin|"M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl~Metformin"
11173308|NCT02014740|BG002|Baseline|Total|Total of all reporting groups
11174281|NCT02020616|OG001|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
10911659|NCT00618371|BG000|Baseline|Group 1|Group receiving raltegravir
11174282|NCT02020616|OG002|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
10911660|NCT00618371|FG000|Participant Flow|Group 1|group to be treated with raltegravir
10911661|NCT00618371|OG000|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification
10911662|NCT00618371|OG000|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification. Samples from 0 participants were analyzed No Patients experienced ≥ 1 log decline in viral RNA, so no samples could be analyzed
10911663|NCT00618371|EG000|Reported Event|Group 1|group treated with raltegravir
10911664|NCT00618410|BG000|Baseline|Entire Study Population|Study population includes subjects receiving interventions in either order.
10911665|NCT00618410|FG000|Participant Flow|Carbon Dioxide, Then Placebo|"Intervention sequence:~Intervention #1: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge~Intervention #2: nasal placebo administered 30 minutes prior to nasal challenge"
10911666|NCT00618410|FG001|Participant Flow|Placebo, Then Carbon Dioxide|"Intervention sequence:~Intervention #1: nasal placebo administered 30 minutes prior to nasal challenge~Intervention #2: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge"
10911667|NCT00618410|OG000|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
10911668|NCT00618410|OG001|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
10911669|NCT00618410|EG000|Reported Event|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
10911670|NCT00618410|EG001|Reported Event|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
10911671|NCT00618436|BG000|Baseline|Levetiracetam|This group will receive treatment with Levetiracetam.
10911672|NCT00618436|BG001|Baseline|Phenytoin|This group will receive treatment with Phenytoin.
10911673|NCT00618436|BG002|Baseline|Total|Total of all reporting groups
10911674|NCT00618436|FG000|Participant Flow|Levetiracetam|This group will receive treatment with Levetiracetam.
10911675|NCT00618436|FG001|Participant Flow|Phenytoin|This group will receive treatment with Phenytoin.
10911676|NCT00618436|OG000|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
10911677|NCT00618436|OG001|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
10911678|NCT00618436|EG000|Reported Event|Levetiracetam|This group will receive treatment with Levetiracetam.
10911679|NCT00618436|EG001|Reported Event|Phenytoin|This group will receive treatment with Phenytoin.
10911680|NCT00618449|BG000|Baseline|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
10911681|NCT00618449|BG001|Baseline|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
11173309|NCT02014740|FG000|Participant Flow|Liraglutide|L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
11173310|NCT02014740|FG001|Participant Flow|Metformin|"M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl~Metformin"
10911682|NCT00618449|BG002|Baseline|Total|Total of all reporting groups
10911683|NCT00618449|FG000|Participant Flow|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
10911684|NCT00618449|FG001|Participant Flow|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
10911685|NCT00618449|OG000|Outcome|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
10911686|NCT00618449|OG001|Outcome|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
10911687|NCT00618449|EG000|Reported Event|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
10911688|NCT00618449|EG001|Reported Event|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
11173311|NCT02014740|OG000|Outcome|Liraglutide|• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
10911689|NCT00618514|BG000|Baseline|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
10911690|NCT00618514|BG001|Baseline|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
10911691|NCT00618514|BG002|Baseline|Total|Total of all reporting groups
11173312|NCT02014740|OG001|Outcome|Metformin|"M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl~Metformin"
11174283|NCT02020616|OG003|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
11174284|NCT02020616|OG004|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
11174285|NCT02020616|OG005|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
11174286|NCT02020616|OG006|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
10911692|NCT00618514|FG000|Participant Flow|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this category had only one limb treated with the Bright tip laser fiber.
10911693|NCT00618514|FG001|Participant Flow|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this arm had only one limb treated with the bare tip laser fiber (control).
10911694|NCT00618514|FG002|Participant Flow|Bright Tip Laser & Bare Tip Laser|Subjects that received testament of both limbs using the investigational device (Bright Tip laser) and the control (bare tip laser)
10911695|NCT00618514|OG000|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
10911696|NCT00618514|OG001|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
10911697|NCT00618514|EG000|Reported Event|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
10911698|NCT00618514|EG001|Reported Event|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
10911699|NCT00618540|BG000|Baseline|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
10911700|NCT00618540|FG000|Participant Flow|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
10911701|NCT00618540|OG000|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
10911702|NCT00618540|OG000|Outcome|Alemtuzumab|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
10911703|NCT00618540|EG000|Reported Event|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
10911704|NCT00618618|BG000|Baseline|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911705|NCT00618618|BG001|Baseline|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911706|NCT00618618|BG002|Baseline|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911707|NCT00618618|BG003|Baseline|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911708|NCT00618618|BG004|Baseline|Total|Total of all reporting groups
10911709|NCT00618618|FG000|Participant Flow|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911710|NCT00618618|FG001|Participant Flow|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
11174287|NCT02020616|OG003|Outcome|50 mg LY3053102|50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
10911711|NCT00618618|FG002|Participant Flow|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911712|NCT00618618|FG003|Participant Flow|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911713|NCT00618618|OG000|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911714|NCT00618618|OG001|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911715|NCT00618618|OG002|Outcome|0Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911716|NCT00618618|OG003|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911717|NCT00618618|OG002|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911718|NCT00618618|EG000|Reported Event|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911719|NCT00618618|EG001|Reported Event|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911720|NCT00618618|EG002|Reported Event|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911721|NCT00618618|EG003|Reported Event|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911722|NCT00618722|BG000|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911723|NCT00618722|BG001|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911724|NCT00618722|BG002|Baseline|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911725|NCT00618722|BG003|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911726|NCT00618722|BG004|Baseline|Total|Total of all reporting groups
10911727|NCT00618722|FG000|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911728|NCT00618722|FG001|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911729|NCT00618722|FG002|Participant Flow|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911730|NCT00618722|FG003|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911731|NCT00618722|OG000|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911732|NCT00618722|OG001|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911733|NCT00618722|OG002|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911734|NCT00618722|OG003|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911735|NCT00618722|EG000|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911736|NCT00618722|EG001|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911737|NCT00618722|EG002|Reported Event|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911738|NCT00618722|EG003|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
10911739|NCT00618748|BG000|Baseline|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
10911740|NCT00618748|BG001|Baseline|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
10911741|NCT00618748|BG002|Baseline|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
10911742|NCT00618748|BG003|Baseline|Total|Total of all reporting groups
10911743|NCT00618748|FG000|Participant Flow|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
10911744|NCT00618748|FG001|Participant Flow|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
10911745|NCT00618748|FG002|Participant Flow|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
10911746|NCT00618748|OG000|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
10911747|NCT00618748|OG001|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
10911748|NCT00618748|OG002|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
10911749|NCT00618748|EG000|Reported Event|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
10911750|NCT00618748|EG001|Reported Event|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
10911751|NCT00618748|EG002|Reported Event|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
10911752|NCT00618774|BG000|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
10911753|NCT00618774|BG001|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
10911754|NCT00618774|BG002|Baseline|Total|Total of all reporting groups
10911755|NCT00618774|FG000|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
10911756|NCT00618774|FG001|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
10911757|NCT00618774|OG000|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
10911758|NCT00618774|OG001|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
10911759|NCT00618774|EG000|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
10911760|NCT00618774|EG001|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
10911761|NCT00618787|BG000|Baseline|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
10911762|NCT00618787|BG001|Baseline|COPA|Regular foam dressing without Polyhexamethylene Biguanide
10911763|NCT00618787|BG002|Baseline|Total|Total of all reporting groups
10911764|NCT00618787|FG000|Participant Flow|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
10911765|NCT00618787|FG001|Participant Flow|COPA|Regular foam dressing without Polyhexamethylene Biguanide
10911766|NCT00618787|OG000|Outcome|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
10911767|NCT00618787|OG001|Outcome|COPA|Regular foam dressing without Polyhexamethylene Biguanide
10911768|NCT00618787|EG000|Reported Event|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
10911769|NCT00618787|EG001|Reported Event|COPA|Regular foam dressing without Polyhexamethylene Biguanide
10911770|NCT00618813|BG000|Baseline|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
10911771|NCT00618813|FG000|Participant Flow|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
10911772|NCT00618813|OG000|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
10911773|NCT00618813|EG000|Reported Event|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
10911774|NCT00618826|BG000|Baseline|Treatment Period|"Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.~Paclitaxel: Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.~Gemcitabine: Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.~Avastin: 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions."
10911775|NCT00618826|FG000|Participant Flow|Paclitaxel + Gemcitabine + Avastin|"Treatment administered once every 2 weeks, 1 cycle will consist of 14 days.~Paclitaxel (administered first) - Patients will be pre-medicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.~Gemcitabine (given after Paclitaxel) - Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.~Avastin - 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions."
11173313|NCT02014740|EG000|Reported Event|Liraglutide|L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
11173314|NCT02014740|EG001|Reported Event|Metformin|"M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl~Metformin"
10911776|NCT00618826|OG000|Outcome|Treatment|Paclitaxel / Gemcitabine
10911777|NCT00618826|OG000|Outcome|Arm 1|all participants
10911778|NCT00618826|EG000|Reported Event|Treatment Period|Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
10911779|NCT00618839|BG000|Baseline|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
10911780|NCT00618839|FG000|Participant Flow|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
10911781|NCT00618839|OG000|Outcome|StrataGraft Skin Tissue|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
10911782|NCT00618839|OG001|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
11174288|NCT02020616|OG006|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC Q1W for 12 weeks
11174289|NCT02020616|OG000|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
11174290|NCT02020616|OG001|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
10911783|NCT00618839|OG000|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
10911784|NCT00618839|OG001|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
10911785|NCT00618839|EG000|Reported Event|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
10911786|NCT00618917|BG000|Baseline|Radiation + MnSOD PL (0.3 mg) + Paclitaxel + Carboplatin|"Radiation + MnSOD PL (0.3 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~1.9-2.1 Gy daily 5 times per week (4-6 hr after the first MnSOD PL dose). The total dose planned at 77.0 Gy with a range of 69-84Gy in 34-38 fractions over 7-8 weeks.~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that contains 0.3 mg of MnSOD PL, given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911787|NCT00618917|BG001|Baseline|Radiation + MnSOD PL (3.0 mg) + Paclitaxel + Carboplatin|"Radiation + MnSOD PL (3.0 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~1.9-2.1 Gy daily 5 times per week (4-6 hr after the first MnSOD PL dose). The total dose planned at 77.0 Gy with a range of 69-84Gy in 34-38 fractions over 7-8 weeks.~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that contains 3.0 mg of MnSOD PL, given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911788|NCT00618917|BG002|Baseline|Radiation + MnSOD PL (30.0 mg) + Paclitaxel + Carboplatin|"Radiation + MnSOD PL (30.0 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~1.9-2.1 Gy daily 5 times per week (4-6 hr after the first MnSOD PL dose). The total dose planned at 77.0 Gy with a range of 69-84Gy in 34-38 fractions over 7-8 weeks.~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that contains 30.0 mg of MnSOD PL, given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911789|NCT00618917|BG003|Baseline|Total|Total of all reporting groups
10911790|NCT00618917|FG000|Participant Flow|MnSOD PL (0.3 mg) + Paclitaxel + Carboplatin|"MnSOD PL (0.3 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that containing 0.3 mg of MnSOD PL, given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~Paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles.~Carboplatin: Chemotherapy to stop the growth of tumor cells."
10911791|NCT00618917|FG001|Participant Flow|MnSOD PL (3.0 mg) + Paclitaxel + Carboplatin|"MnSOD PL (3.0 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that containing 3.0 mg of MnSOD PL, given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~Paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles.~Carboplatin: Chemotherapy to stop the growth of tumor cells."
10911792|NCT00618917|FG002|Participant Flow|MnSOD PL (30.0 mg) + Paclitaxel + Carboplatin|"MnSOD PL (30.0 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that containing 30.0 mg of MnSOD PL, given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~Paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles.~Carboplatin: Chemotherapy to stop the growth of tumor cells."
10911793|NCT00618917|OG000|Outcome|Radiation + MnSOD PL + Paclitaxel + Carboplatin|"Radiation: 1.9-2.1 Gy daily 5 times per week (4-6 hr after the first MnSOD PL dose). The total dose planned at 77.0 Gy with a range of 69-84Gy in 34-38 fractions over 7-8 weeks.~MnSOD PL (0.3, 3, or 30 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that contains either 0.3 mg, 3.0 mg or 30.0 mg (depending on which cohort is open when the subject is entered) of MnSOD PL This will be given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911794|NCT00618917|OG000|Outcome|Radiation + MnSOD PL + Paclitaxel + Carboplatin|"Radiation + MnSOD PL (30 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Radiation: 1.9-2.1 Gy daily 5 times per week (4-6 hr after the first MnSOD PL dose). The total dose planned at 77.0 Gy with a range of 69-84Gy in 34-38 fractions over 7-8 weeks.~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that contains 30.0 mg of MnSOD PL on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911795|NCT00618917|OG000|Outcome|MnSOD PL + Paclitaxel + Carboplatin|"Radiation + MnSOD PL (30 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Radiation: 1.9-2.1 Gy daily 5 times per week (4-6 hr after the first MnSOD PL dose). The total dose planned at 77.0 Gy with a range of 69-84Gy in 34-38 fractions over 7-8 weeks.~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that contains 30.0 mg of MnSOD PL on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911796|NCT00618917|EG000|Reported Event|MnSOD PL (0.3 mg) + Paclitaxel + Carboplatin|"MnSOD PL (0.3 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that containing 0.3 mg of MnSOD PL This will be given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911797|NCT00618917|EG001|Reported Event|MnSOD PL (3.0 mg) + Paclitaxel + Carboplatin|"MnSOD PL (3.0 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that containing 3.0 mg of MnSOD PL This will be given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911798|NCT00618917|EG002|Reported Event|MnSOD PL (30.0 mg) + Paclitaxel + Carboplatin|"MnSOD PL (30.0 mg) + (Paclitaxel + Carboplatin (45mg/m^2))~Manganese Superoxide Dismutase Plasmid Liposome: 15 ml of liquid that containing 30.0 mg of MnSOD PL This will be given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.~carboplatin: Chemotherapy to stop the growth of tumor cells.~paclitaxel: Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles."
10911799|NCT00618956|BG000|Baseline|Placebo|
10911800|NCT00618956|BG001|Baseline|Milnacipran|
10911801|NCT00618956|BG002|Baseline|Total|Total of all reporting groups
10911802|NCT00618956|FG000|Participant Flow|Placebo|ITT N= 93, OC analyzed n=89
10911803|NCT00618956|FG001|Participant Flow|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
10911804|NCT00618956|OG000|Outcome|Placebo|Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
10911805|NCT00618956|OG001|Outcome|Milnacipran|Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
10911806|NCT00618956|OG000|Outcome|Placebo|ITT N= 93, OC analyzed n=89
10911807|NCT00618956|OG001|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
11173315|NCT02015039|BG000|Baseline|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
10911808|NCT00618956|OG000|Outcome|Placebo|Normotensive: ITT N= 42, OC analyzed n=37; hypertensive: ITT N=51, OC analyzed n=47
10911809|NCT00618956|OG001|Outcome|Milnacipran|Normotensive: ITT N= 93, OC analyzed n=82; hypertensive: ITT N=88, OC analyzed n=80
10911810|NCT00618956|OG000|Outcome|Placebo|ITT N=93, OC analyzed n=84
10911811|NCT00618956|OG001|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
10911812|NCT00618956|EG000|Reported Event|Placebo|ITT N= 93, OC analyzed n=89
10911813|NCT00618956|EG001|Reported Event|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
10911814|NCT00618982|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
10911815|NCT00618982|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
10911816|NCT00618982|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
10911817|NCT00618982|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
10911818|NCT00618982|OG001|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
10911819|NCT00618982|OG002|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
11174291|NCT02020616|OG002|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
11174292|NCT02020616|OG003|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
10911820|NCT00618982|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle,600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
10911821|NCT00618995|BG000|Baseline|Totals For Study|All participants in the study.
10911822|NCT00618995|FG000|Participant Flow|Sequence 1: D/C/A/B|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
10911823|NCT00618995|FG001|Participant Flow|Sequence 2: C/B/D/A|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
10911824|NCT00618995|FG002|Participant Flow|Sequence 3: B/A/C/D|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
10911825|NCT00618995|FG003|Participant Flow|Sequence 4: A/D/B/C|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
10911826|NCT00618995|OG000|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
10911827|NCT00618995|OG001|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
10911828|NCT00618995|OG002|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
10911829|NCT00618995|OG003|Outcome|Placebo|Placebo once daily for 7 days
10911830|NCT00618995|EG000|Reported Event|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
10911831|NCT00618995|EG001|Reported Event|ER Niacin|ER Niacin 2 g once daily for 7 days
10911832|NCT00618995|EG002|Reported Event|Laropiprant|Laropiprant 40 mg once daily for 7 days
10911833|NCT00618995|EG003|Reported Event|Placebo|Placebo once daily for 7 days
10911834|NCT00619060|BG000|Baseline|Myristyl, Placebo|"Participants apply topical myristyl nicotinate to the and topical placebo to the other forearm once daily for 4 weeks; Myristyl, Placebo~Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
10911835|NCT00619060|FG000|Participant Flow|Myristyl (Right), Placebo (Left)|"Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left)Topical Myristyl Nicotinate Cream and Placebo~Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
10911836|NCT00619060|FG001|Participant Flow|Myristyl (Left), Placebo (Right)|Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo
10911837|NCT00619060|OG000|Outcome|Myristyl Nicotinate Cream|Participants apply topical myristyl nicotinate to one forearm.
10911838|NCT00619060|OG001|Outcome|Topical Placebo Cream|Participants apply topical placebo cream to one forearm.
10911839|NCT00619060|EG000|Reported Event|Both Forearms|Forearms receiving the Myristyl and Placebo, both arms affected
10911840|NCT00619060|EG001|Reported Event|Placebo Forearm (Only)|Forearms receiving the Placebo
10911841|NCT00619060|EG002|Reported Event|Myristyl Forearm (Only)|Forearms receiving the Myristyl
10911842|NCT00619060|EG003|Reported Event|Other Non-Derm Events|Systemic Other Adverse Events, i.e. Common Cold, Migraine
10911843|NCT00619073|BG000|Baseline|Entire Study Population|Includes groups randomized to receive clopidogrel + aspirin first and placebo + aspirin first
10911844|NCT00619073|FG000|Participant Flow|Clopidogrel Then Placebo|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. placebo) will then be discontinued and aspirin continued for another 45 days.
10911845|NCT00619073|FG001|Participant Flow|Placebo Then Clopidogrel|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. clopidogrel) will then be discontinued and aspirin continued for another 45 days.
10911846|NCT00619073|OG000|Outcome|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
10911847|NCT00619073|OG001|Outcome|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
10911848|NCT00619073|EG000|Reported Event|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
10911849|NCT00619073|EG001|Reported Event|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
10911850|NCT00619099|BG000|Baseline|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
10911851|NCT00619099|BG001|Baseline|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
10911852|NCT00619099|BG002|Baseline|Total|Total of all reporting groups
10911853|NCT00619099|FG000|Participant Flow|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
11174293|NCT02020616|OG004|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
11174294|NCT02020616|EG000|Reported Event|Placebo|Placebo administered by SC QW for 12 weeks
10911854|NCT00619099|FG001|Participant Flow|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
10911855|NCT00619099|OG000|Outcome|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
10911856|NCT00619099|OG001|Outcome|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
10911857|NCT00619099|EG000|Reported Event|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
10911858|NCT00619099|EG001|Reported Event|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
10911859|NCT00619112|BG000|Baseline|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
10911860|NCT00619112|BG001|Baseline|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
10911861|NCT00619112|BG002|Baseline|Total|Total of all reporting groups
11173316|NCT02015039|BG001|Baseline|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
11173317|NCT02015039|BG002|Baseline|Total|Total of all reporting groups
11173318|NCT02015039|FG000|Participant Flow|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
11173319|NCT02015039|FG001|Participant Flow|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
10911862|NCT00619112|FG000|Participant Flow|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
10911863|NCT00619112|FG001|Participant Flow|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
10911864|NCT00619112|OG000|Outcome|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
10911865|NCT00619112|OG001|Outcome|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
10911866|NCT00619112|OG000|Outcome|Glioblastoma With Methylated MGMT|PFS of Glioblastoma patients with methylated MGMT tumors
10911867|NCT00619112|OG001|Outcome|Glioblastoma With Unmethylated MGMT|PFS of Glioblastoma patients with unmethylated MGMT tumors
10911868|NCT00619112|OG002|Outcome|Grade III Glioma With Methylated MGMT|PFS of Grade III Glioma patients with methylated MGMT tumors
10911869|NCT00619112|OG003|Outcome|Grade III Glioma With Unmethylated MGMT|PFS of Grade III Glioma patients with unmethylated MGMT tumors
10911870|NCT00619112|EG000|Reported Event|Temozolomide|
10911871|NCT00619177|BG000|Baseline|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
10911872|NCT00619177|FG000|Participant Flow|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
10911873|NCT00619177|OG000|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
10911874|NCT00619177|EG000|Reported Event|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
10911875|NCT00619190|BG000|Baseline|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
10911876|NCT00619190|BG001|Baseline|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
10911877|NCT00619190|BG002|Baseline|Total|Total of all reporting groups
10911878|NCT00619190|FG000|Participant Flow|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
11174295|NCT02020616|EG001|Reported Event|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
11174296|NCT02020616|EG002|Reported Event|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
11173320|NCT02015039|OG000|Outcome|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
11174297|NCT02020616|EG003|Reported Event|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
11174298|NCT02020616|EG004|Reported Event|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
10911879|NCT00619190|FG001|Participant Flow|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.
10911880|NCT00619190|OG000|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
10911881|NCT00619190|OG001|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
10911882|NCT00619190|EG000|Reported Event|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
10911883|NCT00619190|EG001|Reported Event|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
10911884|NCT00619229|BG000|Baseline|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
10911885|NCT00619229|BG001|Baseline|Placebo|Placebo i.v. for 15 days
10911886|NCT00619229|BG002|Baseline|Total|Total of all reporting groups
10911887|NCT00619229|FG000|Participant Flow|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
10911888|NCT00619229|FG001|Participant Flow|Placebo|Placebo i.v. for 15 days
11174299|NCT02020616|EG005|Reported Event|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
10911889|NCT00619229|OG000|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
10911890|NCT00619229|OG001|Outcome|Placebo|Placebo i.v. for 15 days
10911891|NCT00619229|EG000|Reported Event|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
10911892|NCT00619229|EG001|Reported Event|Placebo|Placebo i.v. for 15 days
10911893|NCT00619255|BG000|Baseline|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
10911894|NCT00619255|BG001|Baseline|Control|Usual Care Control Condition
10911895|NCT00619255|BG002|Baseline|Total|Total of all reporting groups
10911896|NCT00619255|FG000|Participant Flow|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
10911897|NCT00619255|FG001|Participant Flow|Control|Usual Care Control Condition
10911898|NCT00619255|OG000|Outcome|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
10911899|NCT00619255|OG001|Outcome|Control|Usual Care Control Condition
10911900|NCT00619255|EG000|Reported Event|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
10911901|NCT00619255|EG001|Reported Event|Control|Usual Care Control Condition
10911902|NCT00619307|BG000|Baseline|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
10911903|NCT00619307|BG001|Baseline|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
10911904|NCT00619307|BG002|Baseline|Total|Total of all reporting groups
10911905|NCT00619307|FG000|Participant Flow|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
10911906|NCT00619307|FG001|Participant Flow|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
10911907|NCT00619307|OG000|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
11091654|NCT01535664|OG001|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
10911908|NCT00619307|OG001|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
10911909|NCT00619307|EG000|Reported Event|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
10911910|NCT00619307|EG001|Reported Event|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
10911911|NCT00619359|BG000|Baseline|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
10911912|NCT00619359|BG001|Baseline|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
10911913|NCT00619359|BG002|Baseline|Total|Total of all reporting groups
10911914|NCT00619359|FG000|Participant Flow|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
10911915|NCT00619359|FG001|Participant Flow|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
10911916|NCT00619359|OG000|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
10911917|NCT00619359|OG001|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
10911918|NCT00619359|EG000|Reported Event|Fosaprepitant|"Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.~4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
10911919|NCT00619359|EG001|Reported Event|Aprepitant|"Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.~6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
10911920|NCT00619385|BG000|Baseline|Proellex 100 mg|"Proellex 100 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
10911921|NCT00619385|BG001|Baseline|Proellex 150 mg|"Proellex 150 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
10911922|NCT00619385|BG002|Baseline|Proellex 200 mg|"Proellex 200 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
10911923|NCT00619385|BG003|Baseline|Total|Total of all reporting groups
10911924|NCT00619385|FG000|Participant Flow|Proellex 100 mg|Proellex 100 mg daily for 7 days
10911925|NCT00619385|FG001|Participant Flow|Proellex 150 mg|Proellex 150 mg daily for 7 days
10911926|NCT00619385|FG002|Participant Flow|Proellex 200 mg|Proellex 200 mg daily for 7 days
10911927|NCT00619385|OG000|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
10911928|NCT00619385|OG001|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
10911929|NCT00619385|OG002|Outcome|Proellex 200 mg Caps|Proellex 200 mg daily for 7 days capsules
10911930|NCT00619385|OG003|Outcome|Proellex 200 mg Vials|Proellex 200 mg daily for 7 days vials
10911931|NCT00619385|OG002|Outcome|Proellex 200 mg Caps|Proellex 200 mg capsules daily for 7 days
10911932|NCT00619385|OG003|Outcome|Proellex 200 mg Vials|Proellex 200 mg vials daily for 7 days
10911933|NCT00619385|EG000|Reported Event|Proellex 100 mg|Proellex 100 mg daily for 7 days
10911934|NCT00619385|EG001|Reported Event|Proellex 150 mg|Proellex 150 mg daily for 7 days
10911935|NCT00619385|EG002|Reported Event|Proellex 200 mg|Proellex 200 mg daily for 7 days
10911936|NCT00619476|BG000|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
10911937|NCT00619476|BG001|Baseline|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
10911938|NCT00619476|BG002|Baseline|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
10911939|NCT00619476|BG003|Baseline|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
10911940|NCT00619476|BG004|Baseline|Total|Total of all reporting groups
10911941|NCT00619476|FG000|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
10911942|NCT00619476|FG001|Participant Flow|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
10911943|NCT00619476|FG002|Participant Flow|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
10911944|NCT00619476|FG003|Participant Flow|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
10911945|NCT00619476|OG000|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
10911946|NCT00619476|OG001|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
10911947|NCT00619476|OG002|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
10911948|NCT00619476|OG003|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
10911949|NCT00619476|EG000|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
10911950|NCT00619476|EG001|Reported Event|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
10911951|NCT00619476|EG002|Reported Event|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
10911952|NCT00619476|EG003|Reported Event|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
10911953|NCT00619489|BG000|Baseline|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
10911954|NCT00619489|BG001|Baseline|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
10911955|NCT00619489|BG002|Baseline|Total|Total of all reporting groups
10911956|NCT00619489|FG000|Participant Flow|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
10911957|NCT00619489|FG001|Participant Flow|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
10911958|NCT00619489|OG000|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
10911959|NCT00619489|OG001|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
10911960|NCT00619489|EG000|Reported Event|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
10911961|NCT00619489|EG001|Reported Event|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
10911962|NCT00619502|BG000|Baseline|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
11174300|NCT02020616|EG006|Reported Event|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
10911963|NCT00619502|BG001|Baseline|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
10911964|NCT00619502|BG002|Baseline|Total|Total of all reporting groups
10911965|NCT00619502|FG000|Participant Flow|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
10911966|NCT00619502|FG001|Participant Flow|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
10911967|NCT00619502|OG000|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
10911968|NCT00619502|OG001|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
10911969|NCT00619502|OG000|Outcome|DTaP-IPV-HepB-PRP-T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
10911970|NCT00619502|OG001|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
10911971|NCT00619502|EG000|Reported Event|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
10911972|NCT00619502|EG001|Reported Event|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
10911973|NCT00619619|BG000|Baseline|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
10911974|NCT00619619|BG001|Baseline|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
10911975|NCT00619619|BG002|Baseline|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
10911976|NCT00619619|BG003|Baseline|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
10911977|NCT00619619|BG004|Baseline|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
10911978|NCT00619619|BG005|Baseline|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
10911979|NCT00619619|BG006|Baseline|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
10911980|NCT00619619|BG007|Baseline|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
10911981|NCT00619619|BG008|Baseline|Total|Total of all reporting groups
10911982|NCT00619619|FG000|Participant Flow|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
10911983|NCT00619619|FG001|Participant Flow|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
10911984|NCT00619619|FG002|Participant Flow|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
10911985|NCT00619619|FG003|Participant Flow|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
10911986|NCT00619619|FG004|Participant Flow|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
10911987|NCT00619619|FG005|Participant Flow|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
10911988|NCT00619619|FG006|Participant Flow|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
10911989|NCT00619619|FG007|Participant Flow|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
10911990|NCT00619619|OG000|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
10911991|NCT00619619|OG001|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
10911992|NCT00619619|OG002|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
10911993|NCT00619619|OG003|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
10911994|NCT00619619|OG004|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
10911995|NCT00619619|OG005|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
10911996|NCT00619619|OG006|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
11342184|NCT03700385|OG000|Outcome|IOWA Approach Endocardial Ablation|"Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation.~IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System"
10911997|NCT00619619|OG007|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
10911998|NCT00619619|OG000|Outcome|Desvenlafaxine - Combined Children Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels.
10911999|NCT00619619|OG001|Outcome|Desvenlafaxine - Combined Adolescent Cohorts|Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
10912000|NCT00619619|OG000|Outcome|Desvenlafaxine - Combined Children and Adolescent Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels and Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
10912001|NCT00619619|EG000|Reported Event|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
11342185|NCT03700385|EG000|Reported Event|IOWA Approach Endocardial Ablation|"Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation.~IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System"
10912002|NCT00619619|EG001|Reported Event|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
10912003|NCT00619619|EG002|Reported Event|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
10912004|NCT00619619|EG003|Reported Event|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
10912005|NCT00619619|EG004|Reported Event|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
10912006|NCT00619619|EG005|Reported Event|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
10912007|NCT00619619|EG006|Reported Event|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
10912008|NCT00619619|EG007|Reported Event|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
10912009|NCT00619645|BG000|Baseline|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10912010|NCT00619645|FG000|Participant Flow|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10912011|NCT00619645|OG000|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10912012|NCT00619645|EG000|Reported Event|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
10912013|NCT00619684|BG000|Baseline|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
10912014|NCT00619684|FG000|Participant Flow|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
10912015|NCT00619684|OG000|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
10912016|NCT00619684|EG000|Reported Event|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
10912017|NCT00619723|BG000|Baseline|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
10912018|NCT00619723|BG001|Baseline|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
10912019|NCT00619723|BG002|Baseline|Total|Total of all reporting groups
10912020|NCT00619723|FG000|Participant Flow|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
11342186|NCT03700671|BG000|Baseline|High Intensity Interval Training|Perform High intensity interval training twice per week for 8 weeks
10912021|NCT00619723|FG001|Participant Flow|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
10912022|NCT00619723|OG000|Outcome|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
10912023|NCT00619723|OG001|Outcome|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
10912024|NCT00619723|EG000|Reported Event|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
10912025|NCT00619723|EG001|Reported Event|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
10912026|NCT00619762|BG000|Baseline|LTN - Porcine Acellulare Dermal Matrix in Breast Recon|This was a single arm sudy without a control arm LTM used to reinforce weak tissue in breast reconstruction surgery
10912027|NCT00619762|FG000|Participant Flow|LTM - Porcine Acellular Dermal Matrix in Breast Reconstruct|"This was a single arm sudy without a control arm~Use of LTM to reinforce weak tissue in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction."
10912028|NCT00619762|OG000|Outcome|Treatment Arm|all available patients/breasts who completed specified visit
10912029|NCT00619762|OG000|Outcome|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
10912030|NCT00619762|EG000|Reported Event|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
10912031|NCT00619801|BG000|Baseline|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10912032|NCT00619801|BG001|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10912033|NCT00619801|BG002|Baseline|Total|Total of all reporting groups
10912034|NCT00619801|FG000|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10912035|NCT00619801|FG001|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10912036|NCT00619801|OG000|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10912037|NCT00619801|OG001|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10912038|NCT00619801|EG000|Reported Event|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
11342187|NCT03700671|BG001|Baseline|Circuit Training|Perform Circuit training twice per week for 8 weeks
10912039|NCT00619801|EG001|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10912040|NCT00619827|BG000|Baseline|300 IR|300 IR grass pollen allergen extract tablet
10912041|NCT00619827|BG001|Baseline|Placebo|Placebo tablet
10912042|NCT00619827|BG002|Baseline|Total|Total of all reporting groups
10912043|NCT00619827|FG000|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
10912044|NCT00619827|FG001|Participant Flow|Placebo|Placebo tablet
10912045|NCT00619827|OG000|Outcome|300 IR|300 IR grass pollen allergen extract tablet
10912046|NCT00619827|OG001|Outcome|Placebo|Placebo tablet
10912047|NCT00619827|EG000|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
10912048|NCT00619827|EG001|Reported Event|Placebo|Placebo tablet
10912049|NCT00619866|BG000|Baseline|Placebo|Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.
10912050|NCT00619866|BG001|Baseline|Elagolix 150 mg|Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.
10912051|NCT00619866|BG002|Baseline|Elagolix 250 mg|Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
10912052|NCT00619866|BG003|Baseline|Total|Total of all reporting groups
10912053|NCT00619866|FG000|Participant Flow|Placebo|Participants received placebo tablets once a day (QD) for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.
10912054|NCT00619866|FG001|Participant Flow|Elagolix 150 mg|Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.
10912055|NCT00619866|FG002|Participant Flow|Elagolix 250 mg|Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
10912056|NCT00619866|FG003|Participant Flow|Placebo / Elagolix 150 mg|Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.
10912057|NCT00619866|FG004|Participant Flow|Placebo / Elagolix 250 mg|Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
10912058|NCT00619866|OG000|Outcome|Placebo|Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.
10912059|NCT00619866|OG001|Outcome|Elagolix 150 mg|Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.
10912060|NCT00619866|OG002|Outcome|Elagolix 250 mg|Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
10912061|NCT00619866|OG000|Outcome|Elagolix 150 mg|Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.
10912062|NCT00619866|OG001|Outcome|Elagolix 250 mg|Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
10912063|NCT00619866|OG002|Outcome|Placebo / Elagolix 150 mg|Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.
10912064|NCT00619866|OG003|Outcome|Placebo / Elagolix 250 mg|Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
10912065|NCT00619866|EG000|Reported Event|Placebo|Participants received elagolix 150 mg tablets once a day for 12 weeks.
10912066|NCT00619866|EG001|Reported Event|Elagolix 150 mg|"Participants initially randomized to elagolix 150 mg received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.~Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks."
10912067|NCT00619866|EG002|Reported Event|Elagolix 250 mg|"Participants initially randomized to elagolix 250 mg received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.~Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks."
10912068|NCT00619892|BG000|Baseline|Quetiapine|Quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
10912069|NCT00619892|BG001|Baseline|Placebo|Placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
10912070|NCT00619892|BG002|Baseline|Total|Total of all reporting groups
10912071|NCT00619892|FG000|Participant Flow|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
10912072|NCT00619892|FG001|Participant Flow|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
10912073|NCT00619892|OG000|Outcome|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
10912074|NCT00619892|OG001|Outcome|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
11091655|NCT01535664|EG000|Reported Event|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
11091656|NCT01535664|EG001|Reported Event|Dalfampridine-ER Withdrawn|
11342188|NCT03700671|BG002|Baseline|Total|Total of all reporting groups
10912075|NCT00619892|OG000|Outcome|Quetiapine XR|"Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy & the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, & 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).~quetiapine XR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg."
10912076|NCT00619892|OG001|Outcome|Placebo|"Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).~placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication."
10912077|NCT00619892|EG000|Reported Event|Quietapine Group|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
10912078|NCT00619892|EG001|Reported Event|Placebo Group|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
10912079|NCT00619918|BG000|Baseline|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
10912080|NCT00619918|BG001|Baseline|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
10912081|NCT00619918|BG002|Baseline|Total|Total of all reporting groups
10912082|NCT00619918|FG000|Participant Flow|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
11173321|NCT02015039|OG001|Outcome|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
10912083|NCT00619918|FG001|Participant Flow|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
10912084|NCT00619918|OG000|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
10912085|NCT00619918|OG001|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
10912086|NCT00619918|EG000|Reported Event|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
10912087|NCT00619918|EG001|Reported Event|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
10912088|NCT00619957|BG000|Baseline|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
10912089|NCT00619957|BG001|Baseline|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
10912090|NCT00619957|BG002|Baseline|Total|Total of all reporting groups
10912091|NCT00619957|FG000|Participant Flow|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
10912092|NCT00619957|FG001|Participant Flow|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
10912093|NCT00619957|OG000|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
10912094|NCT00619957|OG001|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
10912095|NCT00619957|EG000|Reported Event|Placebo Year 2|Placebo tablet once weekly Years 1 & 2
10912096|NCT00619957|EG001|Reported Event|Risedronate Year 2|Risedronate 35 mg tablet once weekly Years 1 & 2
10912097|NCT00619957|EG002|Reported Event|Placebo-Risedronate Year 4|Placebo once weekly Years 1 & 2 followed by risedronate 35 mg once weekly Years 3 & 4
10912098|NCT00619957|EG003|Reported Event|Risedronate Year 4|Risedronate 35 mg tablet once weekly Years 1 thru 4
10912099|NCT00619970|BG000|Baseline|Healthy Control|Healthy controls
10912100|NCT00619970|BG001|Baseline|Children Receiving Rifaximin|2/3 Patients with CAP
10912101|NCT00619970|BG002|Baseline|Children Receiving Placebo|1/3 patients with CAP
10912102|NCT00619970|BG003|Baseline|Total|Total of all reporting groups
10912103|NCT00619970|FG000|Participant Flow|Healthy Control|Healthy controls
10912104|NCT00619970|FG001|Participant Flow|Children Receiving Rifaximin|2/3 Patients with CAP
10912105|NCT00619970|FG002|Participant Flow|Children Receiving Placebo|1/3 patients with CAP
10912106|NCT00619970|OG000|Outcome|Healthy Control|Healthy controls
10912107|NCT00619970|OG001|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
10912108|NCT00619970|OG002|Outcome|Children Receiving Placebo|1/3 patients with CAP
10912109|NCT00619970|OG000|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
10912110|NCT00619970|OG001|Outcome|Children Receiving Placebo|1/3 patients with CAP
10912111|NCT00619970|EG000|Reported Event|Healthy Control|Healthy controls
10912112|NCT00619970|EG001|Reported Event|Children Receiving Rifaximin|2/3 Patients with CAP
10912113|NCT00619970|EG002|Reported Event|Children Receiving Placebo|1/3 patients with CAP
10912114|NCT00619983|BG000|Baseline|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912115|NCT00619983|BG001|Baseline|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912116|NCT00619983|BG002|Baseline|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
11173322|NCT02015039|EG000|Reported Event|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
11173323|NCT02015039|EG001|Reported Event|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
11173324|NCT02015065|BG000|Baseline|200 mg Vandetanib Adult|Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.
11173325|NCT02015065|BG001|Baseline|300 mg Vandetanib Adult|"Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.~If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose"
11173326|NCT02015065|BG002|Baseline|Dose Level 100mg/m^2 Vandetanib Pediatric|Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
11173327|NCT02015065|BG003|Baseline|Total|Total of all reporting groups
11173328|NCT02015065|FG000|Participant Flow|200 mg Vandetanib Adult|Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.
10912117|NCT00619983|BG003|Baseline|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
11173329|NCT02015065|FG001|Participant Flow|300 mg Vandetanib Adult|"Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.~If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose"
11173330|NCT02015065|FG002|Participant Flow|Dose Level 100mg/m^2 Vandetanib Pediatric|Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
11173331|NCT02015065|OG000|Outcome|200 mg Vandetanib Adult|Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.
11173332|NCT02015065|OG001|Outcome|300 mg Vandetanib Adult|"Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.~If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose"
11173333|NCT02015065|OG002|Outcome|Dose Level 100mg/m^2 Vandetanib Pediatric|Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
10912118|NCT00619983|BG004|Baseline|Total|Total of all reporting groups
10912119|NCT00619983|FG000|Participant Flow|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912120|NCT00619983|FG001|Participant Flow|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
11173334|NCT02015065|EG000|Reported Event|200 mg Vandetanib Adult|Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.
11173335|NCT02015065|EG001|Reported Event|300 mg Vandetanib Adult|"Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.~If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose"
11173336|NCT02015065|EG002|Reported Event|Dose Level 100mg/m^2 Vandetanib Pediatric|Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
11173337|NCT02015104|BG000|Baseline|Bacillus Calmette-Guerin (BCG) + PANVAC|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10^9 pfu SQ at weeks 3, 7, 11, and 15~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis~PANVAC:A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3)."
10912121|NCT00619983|FG002|Participant Flow|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912122|NCT00619983|FG003|Participant Flow|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912123|NCT00619983|OG000|Outcome|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912124|NCT00619983|OG001|Outcome|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912125|NCT00619983|OG002|Outcome|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912126|NCT00619983|OG003|Outcome|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912127|NCT00619983|EG000|Reported Event|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912128|NCT00619983|EG001|Reported Event|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912129|NCT00619983|EG002|Reported Event|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912130|NCT00619983|EG003|Reported Event|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
10912131|NCT00620022|BG000|Baseline|Entire Study Population|The entire study population includes the group of patients who received indacaterol 300 μg in the first treatment period followed by placebo in the second treatment period and the group of patients who received placebo in the first treatment period followed by indacaterol 300 μg in the second treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912132|NCT00620022|FG000|Participant Flow|Indacaterol 300 μg Followed by Placebo|Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912133|NCT00620022|FG001|Participant Flow|Placebo Followed by Indacaterol 300 μg|Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912134|NCT00620022|OG000|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912135|NCT00620022|OG001|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912136|NCT00620022|EG000|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912137|NCT00620022|EG001|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912138|NCT00620061|BG000|Baseline|Lubiprostone|Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks
10912139|NCT00620061|FG000|Participant Flow|Lubiprostone|Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks
10912140|NCT00620061|OG000|Outcome|All Participants|Lubiprostone: 24 mcg capsules twice daily (BID)
10912141|NCT00620061|OG000|Outcome|All Participants|Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
10912142|NCT00620061|EG000|Reported Event|All Participants|Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
10912143|NCT00620074|BG000|Baseline|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
11091657|NCT01535729|BG000|Baseline|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
11091658|NCT01535729|FG000|Participant Flow|Non-small Cell Lung Cancer (NSCLC) Elderly Participants|Elderly Participants (greater than or equal to [≥] 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
11091659|NCT01535729|OG000|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
10912144|NCT00620074|FG000|Participant Flow|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
10912145|NCT00620074|OG000|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
10912146|NCT00620074|EG000|Reported Event|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
10912147|NCT00620113|BG000|Baseline|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912148|NCT00620113|BG001|Baseline|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912149|NCT00620113|BG002|Baseline|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912150|NCT00620113|BG003|Baseline|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912151|NCT00620113|BG004|Baseline|Total|Total of all reporting groups
10912152|NCT00620113|FG000|Participant Flow|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912153|NCT00620113|FG001|Participant Flow|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912154|NCT00620113|FG002|Participant Flow|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912155|NCT00620113|FG003|Participant Flow|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912156|NCT00620113|OG000|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912157|NCT00620113|OG001|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912158|NCT00620113|OG002|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912159|NCT00620113|OG003|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912160|NCT00620113|EG000|Reported Event|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912161|NCT00620113|EG001|Reported Event|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912162|NCT00620113|EG002|Reported Event|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912163|NCT00620113|EG003|Reported Event|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
10912164|NCT00620126|BG000|Baseline|Intervention|UC Home Automated Telemanagement
10912165|NCT00620126|BG001|Baseline|Control|Best Available Care
10912166|NCT00620126|BG002|Baseline|Total|Total of all reporting groups
10912167|NCT00620126|FG000|Participant Flow|UC Home Automated Telemanagement|The UC HAT home unit consists of a netbook computer and an electronic weight scale. Participants answer questions regarding symptoms, side effects, adherence, and receive disease-specific education using the home unit. The home unit automatically transmits the results to the decision support server after each self-testing session. Participants completed self-testing weekly. Updated action plans are automatically transmitted to participant home units if certain criteria are met. If certain clinical conditions are met, email alerts are sent to the nurse coordinator. The coordinator reviews the information and if necessary consults the medical provider and the participant for management changes.
10912168|NCT00620126|FG001|Participant Flow|Best Available Care|The standard of care for participants in this study is modeled after the standard of care at our institution, and based on current evidence-based guidelines including comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. We expanded the care received by controls to make the groups more comparable. First, we provided the control group with all currently available educational fact sheets from the Crohn's and Colitis Foundation at the time of group allocation. Second, we provided the control group with individualized written action plans at the time of group assignment without reinforcement.
10912169|NCT00620126|OG000|Outcome|Intervention|UC Home Automated Telemanagement
10912170|NCT00620126|OG001|Outcome|Control|Best Available Care
10912171|NCT00620126|EG000|Reported Event|Intervention|UC Home Automated Telemanagement
10912172|NCT00620126|EG001|Reported Event|Control|Best Available Care
10912173|NCT00620191|BG000|Baseline|Placebo|"placebo identical to metformin.~placebo: placebo identical to metformin 2 tablets twice a day titrated from one table once a day. Participants remained on the maximum number of tolerated tablets (0,1,2,3,4)."
10912174|NCT00620191|BG001|Baseline|Metformin|"metformin 1000 mg twice a day~metformin: metformin 1000 mg twice a day titrated from 500 mg once a day.Participants remained on the maximum number of tolerated tablets (0,1,2,3,4)."
10912175|NCT00620191|BG002|Baseline|Total|Total of all reporting groups
11173338|NCT02015104|BG001|Baseline|Bacillus Calmette-Guerin (BCG) Alone|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis"
10912176|NCT00620191|FG000|Participant Flow|Placebo|"placebo identical to metformin.~placebo: placebo identical to metformin 2 tablets twice a day titrated from one table once a day"
10912177|NCT00620191|FG001|Participant Flow|Metformin|"metformin 1000 mg twice a day~metformin: metformin 1000 mg twice a day titrated from 500 mg once a day"
10912178|NCT00620191|OG000|Outcome|Placebo|"Placebo identical to metformin.~placebo: placebo identical to metformin 2 tablets twice a day titrated from one tablet once a day. Participants remained on the highest tolerated dose (0,1,2,3,4 tablets)."
10912179|NCT00620191|OG001|Outcome|Metformin|"Metformin 1000 mg twice a day~metformin: metformin 1000 mg twice a day titrated from 500 mg once a day. Participants remained on the highest tolerated dose (0,1,2,3,4 tablets of 500 mg each)."
10912180|NCT00620191|OG000|Outcome|Placebo|"placebo identical to metformin.~placebo: placebo identical to metformin 2 tablets twice a day titrated from one table once a day. Participants were maintained on the highest tolerated dose (0,1,2,3,4 tablets)."
10912181|NCT00620191|OG001|Outcome|Metformin|"metformin 1000 mg twice a day~metformin: metformin 1000 mg twice a day titrated from 500 mg once a day.Participants were maintained on the highest tolerated dose (0,1,2,3,4 tablets of 500 mg each)."
10912182|NCT00620191|OG000|Outcome|Placebo|"Placebo identical to metformin.~placebo: placebo identical to metformin 2 tablets twice a day titrated from one table once a day. Participants remained on the highest tolerated dose (0,1,2,3,4 tablets)."
10912183|NCT00620191|OG000|Outcome|Placebo|"placebo identical to metformin.~placebo: placebo identical to metformin 2 tablets twice a day titrated from one table once a day. Participants remained on the highest tolerated dose (0,1,2,3,4 tablets)."
10912184|NCT00620191|OG001|Outcome|Metformin|"metformin 1000 mg twice a day~metformin: metformin 1000 mg twice a day titrated from 500 mg once a day.Participants remained on the highest tolerated dose (0,1,2,3,4 tablets of 500 mg each)."
10912185|NCT00620191|EG000|Reported Event|Placebo|"Matching placebo~placebo: matching identical to metformin 2 tablets twice a day titrated from one table once a day"
10912186|NCT00620191|EG001|Reported Event|Metformin|"metformin 1000 mg twice a day~metformin: metformin 1000 mg twice a day titrated from 500 mg once a day"
10912187|NCT00620282|BG000|Baseline|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
11173339|NCT02015104|BG002|Baseline|Total|Total of all reporting groups
10912188|NCT00620282|BG001|Baseline|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
10912189|NCT00620282|BG002|Baseline|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
10912190|NCT00620282|BG003|Baseline|Total|Total of all reporting groups
10912191|NCT00620282|FG000|Participant Flow|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
10912192|NCT00620282|FG001|Participant Flow|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
10912193|NCT00620282|FG002|Participant Flow|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
10912194|NCT00620282|OG000|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
10912195|NCT00620282|OG001|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
10912196|NCT00620282|OG002|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
10912197|NCT00620282|EG000|Reported Event|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
10912198|NCT00620282|EG001|Reported Event|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
10912199|NCT00620282|EG002|Reported Event|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
10912200|NCT00620321|BG000|Baseline|LY2181308|750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
10912201|NCT00620321|BG001|Baseline|LY2181308 + Idarubicin + Cytarabine|"LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.~Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.~Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.~Cycle length: 28 days."
10912202|NCT00620321|BG002|Baseline|Total|Total of all reporting groups
10912203|NCT00620321|FG000|Participant Flow|LY2181308|750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
10912204|NCT00620321|FG001|Participant Flow|LY2181308 + Idarubicin + Cytarabine|"LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.~Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.~Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.~Cycle length: 28 days."
10912205|NCT00620321|OG000|Outcome|LY2181308|750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
10912206|NCT00620321|OG001|Outcome|LY2181308 + Idarubicin + Cytarabine|"LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.~Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.~Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.~Cycle length: 28 days."
10912207|NCT00620321|EG000|Reported Event|LY2181308|750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
10912208|NCT00620321|EG001|Reported Event|LY2181308 + Idarubicin + Cytarabine|"LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.~Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.~Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.~Cycle length: 28 days."
10912209|NCT00620373|BG000|Baseline|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
10912210|NCT00620373|FG000|Participant Flow|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
10912211|NCT00620373|OG000|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
10912212|NCT00620373|OG001|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
10912213|NCT00620373|OG002|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
10912214|NCT00620373|OG000|Outcome|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
10912215|NCT00620373|EG000|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
10912216|NCT00620425|BG000|Baseline|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
10912217|NCT00620425|FG000|Participant Flow|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
10912218|NCT00620425|OG000|Outcome|All Participants at -15 Min Pre-dose|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
10912219|NCT00620425|OG001|Outcome|All Participants Immediately Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
10912220|NCT00620425|OG002|Outcome|1 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
10912221|NCT00620425|OG003|Outcome|4 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
10912222|NCT00620425|OG004|Outcome|8 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
10912223|NCT00620425|OG005|Outcome|24 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
10912224|NCT00620425|OG006|Outcome|48 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
10912225|NCT00620425|OG007|Outcome|72 hr Post-dose|Only 3 subjects were required to return on Day 4. Day 4 assessments included a 72 hour assessment for the first and second injections and a 48 hour assessment for the third injection.
10912226|NCT00620425|EG000|Reported Event|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
10912227|NCT00620503|BG000|Baseline|25 mg Proellex|"Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.~Proellex 25 mg capsule, Formulation A, fed state.~Proellex 25 mg Formulation B, fed state.~Proellex 25 mg Formulation B, fasting state."
10912228|NCT00620503|FG000|Participant Flow|TP1: Fed A, TP2: Fasting B, TP3:Fed B|"Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.~Proellex 25 mg capsule, Formulation A, fed state.~Proellex 25 mg Formulation B, fed state.~Proellex 25 mg Formulation B, fasting state."
10912229|NCT00620503|FG001|Participant Flow|TP1: Fed B, TP2: Fed A, TP3: Fasting B|"Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.~Proellex 25 mg capsule, Formulation A, fed state.~Proellex 25 mg Formulation B, fed state.~Proellex 25 mg Formulation B, fasting state."
10912230|NCT00620503|FG002|Participant Flow|TP1: Fasting B, TP2: Fed B, TP3: Fed A|"Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.~Proellex 25 mg capsule, Formulation A, fed state.~Proellex 25 mg Formulation B, fed state.~Proellex 25 mg Formulation B, fasting state."
10912231|NCT00620503|FG003|Participant Flow|TP1: Fed A, TP2: Fed B, TP3: Fasting B|"Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.~Proellex 25 mg capsule, Formulation A, fed state.~Proellex 25 mg Formulation B, fed state.~Proellex 25 mg Formulation B, fasting state."
10912232|NCT00620503|FG004|Participant Flow|TP1: Fasting B, TP2: Fed A, TP3: Fed B|"Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.~Proellex 25 mg capsule, Formulation A, fed state.~Proellex 25 mg Formulation B, fed state.~Proellex 25 mg Formulation B, fasting state."
10912233|NCT00620503|FG005|Participant Flow|TP1: Fed B, TP2: Fasting B, TP3: Fed A|"Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.~Proellex 25 mg capsule, Formulation A, fed state.~Proellex 25 mg Formulation B, fed state.~Proellex 25 mg Formulation B, fasting state."
10912234|NCT00620503|OG000|Outcome|Formulation A Fed|Single dose of Proellex 25 mg formulation A, fed
10912235|NCT00620503|OG001|Outcome|Formulation B Fed|Single dose of Proellex 25 mg formulation B, fed
10912236|NCT00620503|OG002|Outcome|Formulation B Fasted|Single dose of Proellex 25 mg formulation B, fasted
10912237|NCT00620503|EG000|Reported Event|Single Dose of Proellex 25 mg Formulation A, Fed|Formulation A: One Proellex 25 mg formulation A capsule, Fed
10912238|NCT00620503|EG001|Reported Event|Single Dose of Proellex 25 mg Formulation B, Fed|formulation B: One 25 mg Proellex capsule formulation B administered both fed and fasted.
10912239|NCT00620503|EG002|Reported Event|Single Dose of Proellex 25 mg Formulation B, Fasted|Formulation B: One 25 mg Proellex capsule formulation B administered both fed and fasted
10912240|NCT00620542|BG000|Baseline|Rosuvastatin 40 mg|2 years
10912241|NCT00620542|BG001|Baseline|Atorvastatin 80 mg|2 years
10912242|NCT00620542|BG002|Baseline|Total|Total of all reporting groups
10912243|NCT00620542|FG000|Participant Flow|Rosuvastatin 20 mg|2 week run-in period
10912244|NCT00620542|FG001|Participant Flow|Atorvastatin 40 mg|2 week run-in period
10912245|NCT00620542|FG002|Participant Flow|Rosuvastatin 40 mg|2 year core study
10912246|NCT00620542|FG003|Participant Flow|Atorvastatin 80 mg|2 year core study
10912247|NCT00620542|OG000|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
10912248|NCT00620542|OG001|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
10912249|NCT00620542|EG000|Reported Event|Rosuvastatin 20 mg|2 week run-in period
10912250|NCT00620542|EG001|Reported Event|Atorvastatin 40 mg|2 week run-in period
10912251|NCT00620542|EG002|Reported Event|Rosuvastatin 40 mg|2 year core study
10912252|NCT00620542|EG003|Reported Event|Atorvastatin 80 mg|2 year core study
10912253|NCT00620555|BG000|Baseline|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
10915147|NCT00634166|OG000|Outcome|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
10912254|NCT00620555|FG000|Participant Flow|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
10912255|NCT00620555|OG000|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
10912256|NCT00620555|EG000|Reported Event|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
10912257|NCT00620659|BG000|Baseline|All Randomized Participants|All participants randomized in study
10912258|NCT00620659|FG000|Participant Flow|MK0249/Placebo/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
10912259|NCT00620659|FG001|Participant Flow|Placebo/Modafinil/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
10912260|NCT00620659|FG002|Participant Flow|Modafinil/MK0249/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
10912261|NCT00620659|FG003|Participant Flow|MK0249/Modafinil/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
10912262|NCT00620659|FG004|Participant Flow|Placebo/MK0249/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
10912263|NCT00620659|FG005|Participant Flow|Modafinil/Placebo/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
10912264|NCT00620659|OG000|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
11233637|NCT02430090|BG000|Baseline|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
10912265|NCT00620659|OG001|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
10912266|NCT00620659|OG000|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
10912267|NCT00620659|OG001|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
10912268|NCT00620659|OG000|Outcome|MK0249 Top 2 Doses Pooled|"The top 2 doses (the two doses to which most patients were adaptively assigned) were 10 mg and 12 mg.~There were 74 participants who received MK0249 10 and 12 mg over 3 periods (25, 22, and 27 participants for Periods 1, 2, and 3 respectively)."
10912269|NCT00620659|EG000|Reported Event|Placebo|Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
10912270|NCT00620659|EG001|Reported Event|MK0249 5 mg|MK0249 was provided as 1 mg and 5 mg tablets.
10912271|NCT00620659|EG002|Reported Event|MK0249 8 mg|MK0249 was provided as 1 mg and 5 mg tablets.
10912272|NCT00620659|EG003|Reported Event|MK0249 10 mg|MK0249 was provided as 1 mg and 5 mg tablets.
10912273|NCT00620659|EG004|Reported Event|MK0249 12 mg|MK0249 was provided as 1 mg and 5 mg tablets.
10912274|NCT00620659|EG005|Reported Event|Modafinil|Modafinil was provided as 100 mg tablets.
10912275|NCT00620698|BG000|Baseline|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
10912276|NCT00620698|FG000|Participant Flow|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
10912277|NCT00620698|OG000|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
10912278|NCT00620698|EG000|Reported Event|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
10912279|NCT00620711|BG000|Baseline|Preter Infnats With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms. Criteria include Sentinel evnet , Low Apgar, pH less than 7, Neonatal encephalopathy with no other cause and need for mechanical ventialtion~Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
10912280|NCT00620711|FG000|Participant Flow|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
10912281|NCT00620711|OG000|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
10912282|NCT00620711|EG000|Reported Event|Preterm Infants With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.~Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
10912283|NCT00620750|BG000|Baseline|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
10912284|NCT00620750|FG000|Participant Flow|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
10912285|NCT00620750|OG000|Outcome|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
10912286|NCT00620750|EG000|Reported Event|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
10912287|NCT00620763|BG000|Baseline|Entire Study Population|Dietary Intervention: Crossover design, High meat and high potential renal acid load (high PRAL) diet and low meat and low potential renal acid load (low PRAL) diet, consumed in random order.
10912288|NCT00620763|FG000|Participant Flow|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
10912289|NCT00620763|FG001|Participant Flow|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
10912290|NCT00620763|OG000|Outcome|High Meat - High Potential Renal Acid Load|High meat and high potential renal acid load (high PRAL) diet in either the first or second intervention period
10912291|NCT00620763|OG001|Outcome|Low Meat - Low Potential Renal Acid Load|Low meat and low potential renal acid load (low PRAL) diet in either the first or second intervention period
11173340|NCT02015104|FG000|Participant Flow|Bacillus Calmette-Guerin (BCG) + PANVAC|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10^9 pfu SQ at weeks 3, 7, 11, and 15~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis~PANVAC: A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3)."
11173341|NCT02015104|FG001|Participant Flow|Bacillus Calmette-Guerin (BCG) Alone|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis"
11173342|NCT02015104|OG000|Outcome|Bacillus Calmette-Guerin (BCG) + PANVAC|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10^9 pfu SQ at weeks 3, 7, 11, and 15~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis~PANVAC:A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3)."
11173343|NCT02015104|OG001|Outcome|Bacillus Calmette-Guerin (BCG) Alone|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis"
11173344|NCT02015104|OG000|Outcome|Bacillus Calmette-Guerin (BCG) + PANVAC|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10^9 pfu SQ at weeks 3, 7, 11, and 15~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis~PANVAC: A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3)."
10912292|NCT00620763|EG000|Reported Event|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
11173345|NCT02015104|OG000|Outcome|BCG + PANVAC|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10^9 pfu SQ at weeks 3, 7, 11, and 15~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis~PANVAC: A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3)."
11173346|NCT02015104|OG001|Outcome|BCG Alone|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis"
11173347|NCT02015104|EG000|Reported Event|BCG + PANVAC|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10^9 pfu SQ at weeks 3, 7, 11, and 15~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis~PANVAC: A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3)."
11173348|NCT02015104|EG001|Reported Event|BCG Alone|"Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks~TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis"
11173349|NCT02015195|BG000|Baseline|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment~11 males, 5 females treated"
11173350|NCT02015195|BG001|Baseline|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment~8 males, 8 females treated"
10912293|NCT00620763|EG001|Reported Event|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
10912294|NCT00620776|BG000|Baseline|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
10912295|NCT00620776|BG001|Baseline|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
10912296|NCT00620776|BG002|Baseline|Total|Total of all reporting groups
10912297|NCT00620776|FG000|Participant Flow|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
10912298|NCT00620776|FG001|Participant Flow|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
10912299|NCT00620776|OG000|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
10912300|NCT00620776|OG001|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
10912301|NCT00620776|EG000|Reported Event|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
10912302|NCT00620776|EG001|Reported Event|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
10912303|NCT00620815|BG000|Baseline|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
10912304|NCT00620815|BG001|Baseline|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
10912305|NCT00620815|BG002|Baseline|A/S-A|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
11173351|NCT02015195|BG002|Baseline|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment~9 males, 7 females treated"
11173352|NCT02015195|BG003|Baseline|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~1 female treated; adverse local skin reaction; study arm therefore withdrawn"
11173353|NCT02015195|BG004|Baseline|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment~10 males, 6 females treated"
10912306|NCT00620815|BG003|Baseline|Total|Total of all reporting groups
10912307|NCT00620815|FG000|Participant Flow|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
10912308|NCT00620815|FG001|Participant Flow|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
10912309|NCT00620815|FG002|Participant Flow|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
10912310|NCT00620815|OG000|Outcome|T/P-A|One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
10912311|NCT00620815|OG001|Outcome|A/P-T|One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
10912312|NCT00620815|OG002|Outcome|A/S-A|One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
10912313|NCT00620815|OG000|Outcome|T/P-A: In Arm Receiving Tetravalent Vaccine (T)|Local reactions after first vaccination in arm receiving tetravalent influenza vaccine in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
10912314|NCT00620815|OG001|Outcome|T/P-A: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving placebo in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
10912315|NCT00620815|OG002|Outcome|A/P-T: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine(T) on day 22
10912316|NCT00620815|OG003|Outcome|A/P-T: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving Placebo in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
10912317|NCT00620815|OG004|Outcome|A/S-A: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) bon day 22
10912318|NCT00620815|OG005|Outcome|A/S-A: In Arm Receiving Seasonal Influenza Vaccine (S)|Local reactions after first vaccination in arm receiving seasonal influenza vaccination in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
10912319|NCT00620815|OG000|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
10912320|NCT00620815|OG001|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
10912321|NCT00620815|OG002|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
10912322|NCT00620815|OG000|Outcome|T/P-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
10912323|NCT00620815|OG001|Outcome|A/P-T: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
10912324|NCT00620815|OG002|Outcome|A/S-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
10912325|NCT00620815|OG003|Outcome|T/P-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
10912326|NCT00620815|OG004|Outcome|A/P-T: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
10912327|NCT00620815|OG005|Outcome|A/S-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
10912328|NCT00620815|OG002|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
10912329|NCT00620815|EG000|Reported Event|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
10912330|NCT00620815|EG001|Reported Event|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
10912331|NCT00620815|EG002|Reported Event|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
10912332|NCT00620828|BG000|Baseline|Control Group|Subjects receive intra-op saline injection per protocol
10912333|NCT00620828|BG001|Baseline|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
10912334|NCT00620828|BG002|Baseline|Total|Total of all reporting groups
10912335|NCT00620828|FG000|Participant Flow|Control Group|Subjects receive intra-op saline injection per protocol
10912336|NCT00620828|FG001|Participant Flow|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
10912337|NCT00620828|OG000|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
10912338|NCT00620828|OG001|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
10912339|NCT00620828|EG000|Reported Event|Control Group|Subjects receive intra-op saline injection per protocol
10912340|NCT00620828|EG001|Reported Event|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
10912341|NCT00620854|BG000|Baseline|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912342|NCT00620854|BG001|Baseline|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912343|NCT00620854|BG002|Baseline|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912344|NCT00620854|BG003|Baseline|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912345|NCT00620854|BG004|Baseline|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912346|NCT00620854|BG005|Baseline|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912347|NCT00620854|BG006|Baseline|Total|Total of all reporting groups
10912348|NCT00620854|FG000|Participant Flow|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912349|NCT00620854|FG001|Participant Flow|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912350|NCT00620854|FG002|Participant Flow|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912351|NCT00620854|FG003|Participant Flow|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912352|NCT00620854|FG004|Participant Flow|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912353|NCT00620854|FG005|Participant Flow|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912354|NCT00620854|OG000|Outcome|rsCT A|Oral rsCT (150 micrograms)
10912355|NCT00620854|OG001|Outcome|rsCTB|Oral rsCT (200 micrograms)
10912356|NCT00620854|OG002|Outcome|Fortical®|Fortical nasal spray (200 IU)
10912357|NCT00620854|EG000|Reported Event|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912358|NCT00620854|EG001|Reported Event|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912359|NCT00620854|EG002|Reported Event|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912360|NCT00620854|EG003|Reported Event|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912361|NCT00620854|EG004|Reported Event|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912362|NCT00620854|EG005|Reported Event|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
10912363|NCT00620945|BG000|Baseline|Phenoxybenzamine|"Treatment Group~Phenoxybenzamine: Use of Phenoxybenzamine:~Loading dose given at the time of going on CPB:~For patients with obstructing lesions on systemic side:~0.25 mg/kg dose in the bypass circuit~None intravenous~For patients without obstructing left sided lesions:~0.5 mg/kg in the bypass circuit~0.5 mg/kg I.V. at cannulation~Maintenance dose given in the post-operative period:~0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours~0.3 mg/kg P.O. every 8 hours for next 24 hours~0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop~Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group"
10912364|NCT00620945|FG000|Participant Flow|Phenoxybenzamine Treatment|Treatment Group- patients treated with phenoxybenzamine
10912365|NCT00620945|OG000|Outcome|Phenoxybenzamine Treatment|Treatment Group- patients treated with phenoxybenzamine
10912366|NCT00620945|EG000|Reported Event|Phenoxybenzamine|"Treatment Group~Phenoxybenzamine: Use of Phenoxybenzamine:~Loading dose given at the time of going on CPB:~For patients with obstructing lesions on systemic side:~0.25 mg/kg dose in the bypass circuit~None intravenous~For patients without obstructing left sided lesions:~0.5 mg/kg in the bypass circuit~0.5 mg/kg I.V. at cannulation~Maintenance dose given in the post-operative period:~0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours~0.3 mg/kg P.O. every 8 hours for next 24 hours~0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop~Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group"
10912367|NCT00621023|BG000|Baseline|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
10912368|NCT00621023|FG000|Participant Flow|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
10912369|NCT00621023|OG000|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
10912370|NCT00621023|EG000|Reported Event|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
10915148|NCT00634166|OG001|Outcome|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
10915149|NCT00634166|EG000|Reported Event|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
10915150|NCT00634166|EG001|Reported Event|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
10912371|NCT00621049|BG000|Baseline|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
10912372|NCT00621049|BG001|Baseline|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
10912373|NCT00621049|BG002|Baseline|Total|Total of all reporting groups
10912374|NCT00621049|FG000|Participant Flow|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
10912375|NCT00621049|FG001|Participant Flow|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
10912376|NCT00621049|OG000|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
10912377|NCT00621049|OG001|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
10912378|NCT00621049|EG000|Reported Event|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
10912379|NCT00621049|EG001|Reported Event|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
10912380|NCT00621140|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
10912381|NCT00621140|BG001|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
10912382|NCT00621140|BG002|Baseline|Total|Total of all reporting groups
10912383|NCT00621140|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
10912384|NCT00621140|FG001|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
10912385|NCT00621140|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
11173354|NCT02015195|BG005|Baseline|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment~8 makes, 8 females treated"
10912386|NCT00621140|OG001|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
10912387|NCT00621140|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
10912388|NCT00621140|EG001|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
10912389|NCT00621153|BG000|Baseline|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
10912390|NCT00621153|BG001|Baseline|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
10912391|NCT00621153|BG002|Baseline|Total|Total of all reporting groups
10912392|NCT00621153|FG000|Participant Flow|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
10912393|NCT00621153|FG001|Participant Flow|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
10912394|NCT00621153|OG000|Outcome|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
10912395|NCT00621153|OG001|Outcome|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
10912396|NCT00621153|EG000|Reported Event|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
10912397|NCT00621153|EG001|Reported Event|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
10912398|NCT00621179|BG000|Baseline|Group 1|Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization
10912399|NCT00621179|BG001|Baseline|Group 2|"Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization~Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3"
11091660|NCT01535729|EG000|Reported Event|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
10912400|NCT00621179|BG002|Baseline|Group 3|"Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation~Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3"
10912401|NCT00621179|BG003|Baseline|Group 4|Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization.
10912402|NCT00621179|BG004|Baseline|Total|Total of all reporting groups
11233638|NCT02430090|BG001|Baseline|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
11233639|NCT02430090|BG002|Baseline|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
11233640|NCT02430090|BG003|Baseline|Total|Total of all reporting groups
11233641|NCT02430090|FG000|Participant Flow|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
10912403|NCT00621179|FG000|Participant Flow|Group 1|Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol
10912404|NCT00621179|FG001|Participant Flow|Group 2|Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation
10912405|NCT00621179|FG002|Participant Flow|Group 3|Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation
10912406|NCT00621179|FG003|Participant Flow|Group 4|Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol.
10912407|NCT00621179|OG000|Outcome|Group 1|"Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention~No intervention"
10912408|NCT00621179|OG001|Outcome|Group 2|"Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization~Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3"
10912409|NCT00621179|OG002|Outcome|Group 3|"Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation~Leuprolide acetate in depot suspension: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3"
10912410|NCT00621179|OG003|Outcome|Group 4|"Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention~No intervention"
10912411|NCT00621179|EG000|Reported Event|Group 1|Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol
10912412|NCT00621179|EG001|Reported Event|Group 2|Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation
10912413|NCT00621179|EG002|Reported Event|Group 3|Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation
10912414|NCT00621179|EG003|Reported Event|Group 4|Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol.
10912415|NCT00621192|BG000|Baseline|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
10912416|NCT00621192|BG001|Baseline|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
10912417|NCT00621192|BG002|Baseline|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
10912418|NCT00621192|BG003|Baseline|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
10912419|NCT00621192|BG004|Baseline|Total|Total of all reporting groups
10912420|NCT00621192|FG000|Participant Flow|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
10912421|NCT00621192|FG001|Participant Flow|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
10912422|NCT00621192|FG002|Participant Flow|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
10912423|NCT00621192|FG003|Participant Flow|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
10912424|NCT00621192|OG000|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
10912425|NCT00621192|OG001|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
10912426|NCT00621192|OG002|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
10912427|NCT00621192|OG003|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
10912428|NCT00621192|EG000|Reported Event|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
10912429|NCT00621192|EG001|Reported Event|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
10912430|NCT00621192|EG002|Reported Event|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
10912431|NCT00621192|EG003|Reported Event|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
10912432|NCT00621244|BG000|Baseline|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
10912433|NCT00621244|BG001|Baseline|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
10912434|NCT00621244|BG002|Baseline|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
10912435|NCT00621244|BG003|Baseline|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
10912436|NCT00621244|BG004|Baseline|Total|Total of all reporting groups
10912437|NCT00621244|FG000|Participant Flow|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
11173355|NCT02015195|BG006|Baseline|Heated Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Heated Tap Water (40 degrees Celsius)~No treatment~8 males, 8 females treated"
11173356|NCT02015195|BG007|Baseline|Total|Total of all reporting groups
10912438|NCT00621244|FG001|Participant Flow|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
10912439|NCT00621244|FG002|Participant Flow|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
10912440|NCT00621244|FG003|Participant Flow|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
10912441|NCT00621244|OG000|Outcome|Arm 1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912442|NCT00621244|OG001|Outcome|Arm 1, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912443|NCT00621244|OG002|Outcome|Arm 1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912444|NCT00621244|OG003|Outcome|Arm 1, Group X (60 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
10912445|NCT00621244|OG004|Outcome|Arm 1, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912446|NCT00621244|OG005|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912447|NCT00621244|OG006|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912448|NCT00621244|OG007|Outcome|Arm 1, Group Y (40 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912449|NCT00621244|OG008|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912450|NCT00621244|OG000|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912451|NCT00621244|OG001|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912452|NCT00621244|OG002|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912453|NCT00621244|OG003|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912454|NCT00621244|OG004|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912455|NCT00621244|OG005|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912456|NCT00621244|OG006|Outcome|Arm 2, Group Y (60 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912457|NCT00621244|OG000|Outcome|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
10912458|NCT00621244|OG001|Outcome|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
10912459|NCT00621244|OG000|Outcome|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
10912460|NCT00621244|OG001|Outcome|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
10912461|NCT00621244|OG000|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912462|NCT00621244|OG001|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912463|NCT00621244|OG002|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912464|NCT00621244|OG003|Outcome|45 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912465|NCT00621244|OG004|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912466|NCT00621244|OG005|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912467|NCT00621244|OG003|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912468|NCT00621244|OG004|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912469|NCT00621244|OG003|Outcome|Arm 1, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912470|NCT00621244|OG000|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912471|NCT00621244|OG001|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912472|NCT00621244|OG002|Outcome|Arm 1, Group Y (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912473|NCT00621244|OG003|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912474|NCT00621244|OG000|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912475|NCT00621244|OG001|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912476|NCT00621244|OG002|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912477|NCT00621244|OG003|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912478|NCT00621244|OG000|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912479|NCT00621244|OG001|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912480|NCT00621244|OG002|Outcome|Arm 2, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
10912481|NCT00621244|OG000|Outcome|Arm 1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912482|NCT00621244|OG001|Outcome|Arm 1, Group x (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912483|NCT00621244|OG002|Outcome|Arm 1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912484|NCT00621244|OG003|Outcome|Arm 1, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912485|NCT00621244|OG004|Outcome|Arm 1, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912486|NCT00621244|OG005|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912487|NCT00621244|OG006|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912488|NCT00621244|OG007|Outcome|Arm 1, Group Y (40mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912489|NCT00621244|OG008|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912490|NCT00621244|OG000|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
10912491|NCT00621244|OG001|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
10912492|NCT00621244|OG002|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
10912493|NCT00621244|OG003|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
10912494|NCT00621244|OG004|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
10912495|NCT00621244|OG005|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
10912496|NCT00621244|OG006|Outcome|Arm 2, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
10912497|NCT00621244|EG000|Reported Event|Arm1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912498|NCT00621244|EG001|Reported Event|Arm1, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912499|NCT00621244|EG002|Reported Event|Arm1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912500|NCT00621244|EG003|Reported Event|Arm1 GroupX 60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912501|NCT00621244|EG004|Reported Event|Arm1 GroupX 80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912502|NCT00621244|EG005|Reported Event|Arm1 GroupY 20 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912503|NCT00621244|EG006|Reported Event|Arm1 GroupY 30 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912504|NCT00621244|EG007|Reported Event|Arm1 GroupY 40 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912505|NCT00621244|EG008|Reported Event|Arm1 GroupY 60 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912506|NCT00621244|EG009|Reported Event|Arm2 GroupX 30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912507|NCT00621244|EG010|Reported Event|Arm2 GroupX 45 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912508|NCT00621244|EG011|Reported Event|Arm2 GroupX 60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912509|NCT00621244|EG012|Reported Event|Arm2 GroupX 80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
10912510|NCT00621244|EG013|Reported Event|Arm2 GroupY 30 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912511|NCT00621244|EG014|Reported Event|Arm2 GroupY 45 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912512|NCT00621244|EG015|Reported Event|Arm2 GroupY 60 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
10912513|NCT00621257|BG000|Baseline|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
10912514|NCT00621257|BG001|Baseline|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
10912515|NCT00621257|BG002|Baseline|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
10912516|NCT00621257|BG003|Baseline|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
10912517|NCT00621257|BG004|Baseline|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
10912518|NCT00621257|BG005|Baseline|Total|Total of all reporting groups
10912519|NCT00621257|FG000|Participant Flow|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
10912520|NCT00621257|FG001|Participant Flow|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
10912521|NCT00621257|FG002|Participant Flow|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
10912522|NCT00621257|FG003|Participant Flow|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
10912523|NCT00621257|FG004|Participant Flow|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
10912524|NCT00621257|OG000|Outcome|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
10912525|NCT00621257|OG001|Outcome|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
10912526|NCT00621257|OG002|Outcome|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
10912527|NCT00621257|OG000|Outcome|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
10912528|NCT00621257|OG001|Outcome|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
10912529|NCT00621257|EG000|Reported Event|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
10912530|NCT00621257|EG001|Reported Event|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
10912531|NCT00621257|EG002|Reported Event|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
11173357|NCT02015195|FG000|Participant Flow|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
11173358|NCT02015195|FG001|Participant Flow|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
11173359|NCT02015195|FG002|Participant Flow|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
11173360|NCT02015195|FG003|Participant Flow|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
11173361|NCT02015195|FG004|Participant Flow|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
11173362|NCT02015195|FG005|Participant Flow|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment).~No treatment"
11173363|NCT02015195|FG006|Participant Flow|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
11173364|NCT02015195|OG000|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
11173365|NCT02015195|OG001|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
10912532|NCT00621257|EG003|Reported Event|Maintenance A|"400 IU per day of oral vitamin D2~ergocalciferol 8000 IU/ml"
10912533|NCT00621257|EG004|Reported Event|Maintenance B|"1,000 IU of oral vitamin D2 per day from May to October and 2,000 IU of oral vitamin D2 per day of oral vitamin D2 per day from November to April~ergocalciferol 8000 IU/ml"
11173366|NCT02015195|OG002|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
10912534|NCT00621296|BG000|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
10912535|NCT00621296|FG000|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
10912536|NCT00621296|OG000|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
10912537|NCT00621296|EG000|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
10912538|NCT00621309|BG000|Baseline|Cross-Over Trial|Crossover trial, three-armed, randomized. The PXR ligand rifampicin (300 mg/d)was given alone for 7 days in Arm 1, or in daily combination with 450 μmol SFN (Broccoli Sprout extract) in Arm 2; SFN was given alone in arm 3. 29 participants consented, analysis done on 23 who finished all arms.
10912539|NCT00621309|FG000|Participant Flow|Cross-over Trial -Sequence ABC|Three-armed, randomized, crossover trial, 7 days each arm. Arm A: 450 μmol SFN (Broccoli Sprout extract) and Rifampin, then Arm B: 450 μmol SFN (Broccoli Sprout extract), then Arm C: Placebo and Rifampin
10912540|NCT00621309|FG001|Participant Flow|Sequence ACB|Three-armed, randomized, crossover trial, 7 days each arm. Arm A: 450 μmol SFN (Broccoli Sprout extract) and Rifampin then Arm C: Placebo and Rifampin and then Arm B: 450 μmol SFN (Broccoli Sprout extract)
10912541|NCT00621309|FG002|Participant Flow|Sequence BAC|Three-armed, randomized, crossover trial, 7 days each arm. Arm B: 450 μmol SFN (Broccoli Sprout extract) then Arm A: 450 μmol SFN (Broccoli Sprout extract) and Rifampin and then Arm C: Placebo and Rifampin
10912542|NCT00621309|FG003|Participant Flow|Sequence BCA|Three-armed, randomized, crossover trial, 7 days each arm. Arm B: 450 μmol SFN (Broccoli Sprout extract), then Arm C: Placebo and Rifampin, and then Arm A: 450 μmol SFN (Broccoli Sprout extract) and Rifampin
10912543|NCT00621309|FG004|Participant Flow|Sequence CAB|Three-armed, randomized, crossover trial, 7 days each arm. Arm C: Placebo and Rifampin, then Arm A: 450 μmol SFN (Broccoli Sprout extract) and Rifampin and then Arm B: 450 μmol SFN (Broccoli Sprout extract)
10912544|NCT00621309|FG005|Participant Flow|Sequence CBA|Three-armed, randomized, crossover trial, 7 days each arm. Arm C: Placebo and Rifampin, then Arm B: 450 μmol SFN (Broccoli Sprout extract), and then Arm A: 450 μmol SFN (Broccoli Sprout extract) and Rifampin
11173367|NCT02015195|OG003|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
11173368|NCT02015195|OG004|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
11173369|NCT02015195|OG005|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
11173370|NCT02015195|EG000|Reported Event|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
10912545|NCT00621309|OG000|Outcome|Rifampicin Alone|Subjects are given 300 mg / 7 days of rifampicin to induce CYP3A4. Midazolam clearance is measured on the 8th day. Rifampicin: Rifampicin, an antibiotic used to treat TB, is administered at a dose of 300 mg day x 7 days to induce CYP3A5.
10912546|NCT00621309|OG001|Outcome|Broccoli Sprout Extract Plus Rifampin|"Sulforaphane (SFN), a natural product derived from broccoli sprouts, is utilized as a putative inhibitor of ligand (Rifampin) activation of the Pregnane X-receptor. In this arm, both SFN (putative inhibitor of ligand binding to PXR) and Rifampin (strong activating ligand of PXR) are given together.~sulforaphane plus rifampicin: Sulforaphane (SFN) is an isothiocyanate derived from the plant phytochemical, glucoraphinin. It appears to inhibit ligand binding to the ligand activated nuclear transcription factor, Pregnane X-Receptor (PXR). This arm tests the hypothesis that SFN can block ligand binding to the PXR, thereby inhibiting transcriptional activation of PXR-regulated genes. Sulforaphane is administered daily for 7 days as a broccoli sprout extract, at a dose rate of 75 mg (~420 umoles)per day for 7 days. Rifampicin is also administered once per day at a dose rate of 300 mg/day for 7 days."
10912547|NCT00621309|OG002|Outcome|Broccoli Sprout Extract Alone|"This arm involves the administration of Sulforaphane (SFN) alone, in the absence of the PXR ligand, rifampicin. The hypothesis is that SFN will have no effect on the expression of PXR-regulated genes. Alternatively, it is possible that SFN could inhibit as yet unidentified endogenous ligands to the PXR receptor, thereby causing down-regulations of genes regulated wholely or in part by PXR. SFN is administered as a broccoli sprout extract at a dose rate of 75 mg (~420 umoles) per day for 7 days.~sulforaphane alone: Sulforaphane (SFN) is an isothiocyanate derived from the plant phytochemical, glucoraraphinin. It appears to inhibit ligand binding to the ligand activated nuclear transcription factor, Pregnane X-Receptor (PXR). This arm tests the hypothesis that SFN can block ligand binding to the PXR, thereby inhibiting transcriptional activation of PXR-regulated genes"
10912548|NCT00621309|EG000|Reported Event|Cross-over Trial|Randomized, crossover trial. 1: Rifampicin (300 mg/d) given alone for 7 days; 2: daily combination with 450 μmol SFN (Broccoli Sprout extract); 3: SFN alone. 29 participants consented. The powdered broccoli extract imparted a bitter taste to the cheese soup used as vehicle. We had all potential participants try the soup before committing to participate. 3 participants who initially did not object to the taste did dropout and did not finish any of the study arms due to dislike or intolerance of the extract. Two of these participants became nauseated, one also had vomiting but it was determined that the subject was suffering from the flu and thus the response was deemed by our attending physician not to be solely treatment related. Three additional participants did not complete all their study periods (one developed apparent lactose intolerance to the soup, one did not routinely comply with study activities, and one relocated out of state after the second study period).
10912549|NCT00621322|BG000|Baseline|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912550|NCT00621322|BG001|Baseline|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912551|NCT00621322|BG002|Baseline|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912552|NCT00621322|BG003|Baseline|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912553|NCT00621322|BG004|Baseline|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912554|NCT00621322|BG005|Baseline|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912555|NCT00621322|BG006|Baseline|Total|Total of all reporting groups
10912556|NCT00621322|FG000|Participant Flow|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912557|NCT00621322|FG001|Participant Flow|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912558|NCT00621322|FG002|Participant Flow|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912559|NCT00621322|FG003|Participant Flow|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
11173371|NCT02015195|EG001|Reported Event|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
11173372|NCT02015195|EG002|Reported Event|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
11173373|NCT02015195|EG003|Reported Event|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~The first patient treated had an adverse local skin reaction, so this study arm was discontinued"
10912560|NCT00621322|FG004|Participant Flow|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912561|NCT00621322|FG005|Participant Flow|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912562|NCT00621322|OG000|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912563|NCT00621322|OG001|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912564|NCT00621322|OG002|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912565|NCT00621322|OG003|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912566|NCT00621322|OG004|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912567|NCT00621322|OG005|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912568|NCT00621322|EG000|Reported Event|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912569|NCT00621322|EG001|Reported Event|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912570|NCT00621322|EG002|Reported Event|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912571|NCT00621322|EG003|Reported Event|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912572|NCT00621322|EG004|Reported Event|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912573|NCT00621322|EG005|Reported Event|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
10912574|NCT00621348|BG000|Baseline|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
10912575|NCT00621348|BG001|Baseline|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
10912576|NCT00621348|BG002|Baseline|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
10912577|NCT00621348|BG003|Baseline|Total|Total of all reporting groups
10912578|NCT00621348|FG000|Participant Flow|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
10912579|NCT00621348|FG001|Participant Flow|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
10912580|NCT00621348|FG002|Participant Flow|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
10912581|NCT00621348|OG000|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
10912582|NCT00621348|OG001|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
10912583|NCT00621348|OG002|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
10912584|NCT00621348|EG000|Reported Event|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
10912585|NCT00621348|EG001|Reported Event|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
10912586|NCT00621348|EG002|Reported Event|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
10912587|NCT00621504|BG000|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
10912588|NCT00621504|BG001|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
10912589|NCT00621504|BG002|Baseline|Total|Total of all reporting groups
10912590|NCT00621504|FG000|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
10912591|NCT00621504|FG001|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
10912592|NCT00621504|OG000|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
10912593|NCT00621504|OG001|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
10912594|NCT00621504|EG000|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
10912595|NCT00621504|EG001|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
10912596|NCT00621517|BG000|Baseline|Bupropion|Participants will receive 150MG Bupropion nightly.
10912597|NCT00621517|BG001|Baseline|Placebo|Participants will receive matching placebo capsule nightly.
10912598|NCT00621517|BG002|Baseline|Total|Total of all reporting groups
10912599|NCT00621517|FG000|Participant Flow|Bupropion|Participants will receive 150MG Bupropion nightly.
10912600|NCT00621517|FG001|Participant Flow|Placebo|Participants will receive matching placebo capsule nightly.
10912601|NCT00621517|OG000|Outcome|Bupropion|Participants will receive 150MG Bupropion nightly.
10912602|NCT00621517|OG001|Outcome|Placebo|Participants will receive matching placebo capsule nightly.
10912603|NCT00621517|EG000|Reported Event|Bupropion|Participants will receive 150MG Bupropion nightly.
10912604|NCT00621517|EG001|Reported Event|Placebo|Participants will receive matching placebo capsule nightly.
10912605|NCT00621530|BG000|Baseline|Ketorolac|"ketorolac 2 mg~ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
10912606|NCT00621530|BG001|Baseline|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery~placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
10912607|NCT00621530|BG002|Baseline|Total|Total of all reporting groups
10912608|NCT00621530|FG000|Participant Flow|Ketorolac|"ketorolac 2 mg~ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
10912609|NCT00621530|FG001|Participant Flow|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery~placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
10912610|NCT00621530|OG000|Outcome|Ketorolac|"ketorolac 2 mg~ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
10912611|NCT00621530|OG001|Outcome|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery~placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
10912612|NCT00621530|OG000|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
10912613|NCT00621530|OG001|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
10912614|NCT00621530|OG000|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution 2 mg added to the patient's routine spinal anesthetic for surgery
10912615|NCT00621530|EG000|Reported Event|Ketorolac|"ketorolac 2 mg~ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
10912616|NCT00621530|EG001|Reported Event|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery~placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
10912617|NCT00621543|BG000|Baseline|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
10912618|NCT00621543|FG000|Participant Flow|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
10912619|NCT00621543|OG000|Outcome|Single Arm Study|
10912620|NCT00621543|EG000|Reported Event|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
10912621|NCT00621582|BG000|Baseline|Tiotropium Bromide|
10912622|NCT00621582|FG000|Participant Flow|Tiotropium Bromide|
10912623|NCT00621582|OG000|Outcome|Tiotropium Bromide|
10912624|NCT00621582|EG000|Reported Event|Tiotropium Bromide|
10912625|NCT00621621|BG000|Baseline|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
10912626|NCT00621621|BG001|Baseline|Subjects Consented in the Study Not Ablated|Actual Subjects that were consented in the study that did not meet inclusion criteria.
10912627|NCT00621621|BG002|Baseline|Subjects Collected From Published Data|Published evidence about the safety and efficacy of using Medtronic's Freezor® 4 mm CryoCatheter has been reported since the initiation of the CryoFACTS-PAS. The results reported in the literature provide the supplemental data in the same study population as in the PAS and are included to meet the study objectives, as agreed upon with the FDA.
10912628|NCT00621621|BG003|Baseline|Total|Total of all reporting groups
10912629|NCT00621621|FG000|Participant Flow|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
10912630|NCT00621621|FG001|Participant Flow|External Data Supporting the Study|Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.
10912631|NCT00621621|OG000|Outcome|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
10912632|NCT00621621|OG001|Outcome|External Data Supporting the Study|
10912633|NCT00621621|OG000|Outcome|Experimental: Freezor Catheter for AVNRT|Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmiacryoablation
10912634|NCT00621621|OG001|Outcome|External Data Supporting the Study|This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
10912635|NCT00621621|EG000|Reported Event|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
10912636|NCT00621621|EG001|Reported Event|External Data Supporting the Study|"Subjects from publication search with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
10912637|NCT00621686|BG000|Baseline|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912638|NCT00621686|BG001|Baseline|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912639|NCT00621686|BG002|Baseline|Total|Total of all reporting groups
10912640|NCT00621686|FG000|Participant Flow|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912641|NCT00621686|FG001|Participant Flow|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912642|NCT00621686|OG000|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912643|NCT00621686|OG001|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912644|NCT00621686|OG001|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912645|NCT00621686|EG000|Reported Event|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912646|NCT00621686|EG001|Reported Event|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
10912647|NCT00621764|BG000|Baseline|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
10912648|NCT00621764|BG001|Baseline|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
10912649|NCT00621764|BG002|Baseline|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
10912650|NCT00621764|BG003|Baseline|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
10912651|NCT00621764|BG004|Baseline|Total|Total of all reporting groups
10912652|NCT00621764|FG000|Participant Flow|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
10912653|NCT00621764|FG001|Participant Flow|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
10912654|NCT00621764|FG002|Participant Flow|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
10912655|NCT00621764|FG003|Participant Flow|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
10912656|NCT00621764|OG000|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
11173374|NCT02015195|EG004|Reported Event|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
11173375|NCT02015195|EG005|Reported Event|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
10912657|NCT00621764|OG001|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
10912658|NCT00621764|OG002|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
10912659|NCT00621764|OG003|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
10912660|NCT00621764|OG003|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart.
10912661|NCT00621764|EG000|Reported Event|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
10912662|NCT00621764|EG001|Reported Event|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
10912663|NCT00621764|EG002|Reported Event|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
10912664|NCT00621764|EG003|Reported Event|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
10912665|NCT00621777|BG000|Baseline|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.~Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
10912666|NCT00621777|BG001|Baseline|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
10912667|NCT00621777|BG002|Baseline|Total|Total of all reporting groups
10912668|NCT00621777|FG000|Participant Flow|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks.~Double-Blind, Placebo-Controlled, Relapse-Prevention Phase:~Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
10912669|NCT00621777|FG001|Participant Flow|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
10912670|NCT00621777|OG000|Outcome|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.~Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
10912671|NCT00621777|OG001|Outcome|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
10912672|NCT00621777|OG000|Outcome|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks.~Double-Blind, Placebo-Controlled, Relapse-Prevention Phase:~Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
10912673|NCT00621777|EG000|Reported Event|Varenicline Open Label (Open Phase)|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~1. Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks."
10912674|NCT00621777|EG001|Reported Event|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
11173376|NCT02015195|EG006|Reported Event|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
11173377|NCT02015221|BG000|Baseline|ACTitouch|ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
11173378|NCT02015221|BG001|Baseline|Standard Compression Garments|Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
10912675|NCT00621777|EG002|Reported Event|Placebo|2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52
10912676|NCT00621842|BG000|Baseline|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
10912677|NCT00621842|FG000|Participant Flow|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
10912678|NCT00621842|OG000|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
10912679|NCT00621842|EG000|Reported Event|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
10912680|NCT00621855|BG000|Baseline|50mg Dabigatran Etexilate|26 week blinded treatment
10912681|NCT00621855|BG001|Baseline|75mg Dabigatran Etexilate|26 week blinded treatment
10912682|NCT00621855|BG002|Baseline|110mg Dabigatran Etexilate|26 week blinded treatment
10912683|NCT00621855|BG003|Baseline|150mg Dabigatran Etexilate|26 week blinded treatment
10912684|NCT00621855|BG004|Baseline|Placebo|26 week blinded treatment
10912685|NCT00621855|BG005|Baseline|Total|Total of all reporting groups
10912686|NCT00621855|FG000|Participant Flow|50mg Dabigatran Etexilate|26 week blinded treatment
11173379|NCT02015221|BG002|Baseline|Total|Total of all reporting groups
10912687|NCT00621855|FG001|Participant Flow|75mg Dabigatran Etexilate|26 week blinded treatment
10912688|NCT00621855|FG002|Participant Flow|110mg Dabigatran Etexilate|26 week blinded treatment
10912689|NCT00621855|FG003|Participant Flow|150mg Dabigatran Etexilate|26 week blinded treatment
10912690|NCT00621855|FG004|Participant Flow|Placebo|26 week blinded treatment
10912691|NCT00621855|OG000|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
10912692|NCT00621855|OG001|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
10912693|NCT00621855|OG002|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
10912694|NCT00621855|OG003|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
10912695|NCT00621855|OG004|Outcome|Placebo|26 week blinded treatment
10912696|NCT00621855|EG000|Reported Event|50mg Dabigatran Etexilate|26 week blinded treatment
10912697|NCT00621855|EG001|Reported Event|75mg Dabigatran Etexilate|26 week blinded treatment
10912698|NCT00621855|EG002|Reported Event|110mg Dabigatran Etexilate|26 week blinded treatment
10912699|NCT00621855|EG003|Reported Event|150mg Dabigatran Etexilate|26 week blinded treatment
10912700|NCT00621855|EG004|Reported Event|Placebo|26 week blinded treatment
10912701|NCT00621933|BG000|Baseline|All Patients|All patients receiving cataract surgery
10912702|NCT00621933|FG000|Participant Flow|All Patients|All patients receiving cataract surgery
10912703|NCT00621933|OG000|Outcome|All Patients|All patients receiving cataract surgery
10912704|NCT00621933|EG000|Reported Event|All Patients|All patients receiving cataract surgery
10912705|NCT00621946|BG000|Baseline|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
10912706|NCT00621946|BG001|Baseline|Placebo|Placebo Matching Escitalopram taken orally daily.
10912707|NCT00621946|BG002|Baseline|Total|Total of all reporting groups
10912708|NCT00621946|FG000|Participant Flow|Escitalopram|Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
10912709|NCT00621946|FG001|Participant Flow|Matching Placebo|Placebo Matching Escitalopram taken orally daily (for a 12-week duration).
10912710|NCT00621946|OG000|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
10912711|NCT00621946|OG001|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
10912712|NCT00621946|OG001|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
10912713|NCT00621946|EG000|Reported Event|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
10912714|NCT00621946|EG001|Reported Event|Placebo|Placebo Matching Escitalopram taken orally daily.
10912715|NCT00621959|BG000|Baseline|Placebo|Matched placebo tablets once daily
10912716|NCT00621959|BG001|Baseline|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
10912717|NCT00621959|BG002|Baseline|Total|Total of all reporting groups
10912718|NCT00621959|FG000|Participant Flow|Placebo|Matched placebo tablets once daily
10912719|NCT00621959|FG001|Participant Flow|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
10912720|NCT00621959|OG000|Outcome|Placebo|Matched placebo tablets once daily
10912721|NCT00621959|OG001|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
10912722|NCT00621959|EG000|Reported Event|Placebo|Matched placebo tablets once daily
10912723|NCT00621959|EG001|Reported Event|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
10912724|NCT00621985|BG000|Baseline|Experimental Group|These subjects were admitted twice, once while on baseline hydrocortisone and once on dexamethasone.
10912725|NCT00621985|FG000|Participant Flow|Experimental|Baseline hydrocortisone was given at a dose determined by the subject's primary endocrinologist and was given either 2 or 3 times per day as per their home regimen. Experimental therapy with nocturnal dexamethasone given at a dose equivalent to 1/50th of the total daily hydrocortisone dose. This dose was given at 10 PM for three nights with the admission to the hospital occurring on the 3rd day prior to the 3rd evening dose.
10912726|NCT00621985|OG000|Outcome|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
10912727|NCT00621985|OG001|Outcome|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
10912728|NCT00621985|EG000|Reported Event|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
10912729|NCT00621985|EG001|Reported Event|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
10912730|NCT00622180|BG000|Baseline|The Efficacy of Hand NBUVB Vs. Excilite Treatment in Vitiligo|Light therapy with the NBUVB hand-foot box to one hand and the Excilite to the other hand three times a week on non-consecutive days for a total of 12 weeks. The light will be dosed as follows: starting dose for NBUVB will be 200 mJ/cm2 with subsequent dose increases of 15% per treatment as tolerated. For the Excilite device, the starting dose will be 200 mJ with subsequent dose increases of 50 mJ per treatment as tolerated.
10912731|NCT00622180|FG000|Participant Flow|Daavlin Right vs. Excilite Left|Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.
10912732|NCT00622180|FG001|Participant Flow|Excilite Right vs. Daavlin Left|Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light
10912733|NCT00622180|OG000|Outcome|NBUVB|Treatment with NBUVB
10912734|NCT00622180|OG001|Outcome|Monochromatic Excimer Light|One hand treated with monochromatic excimer light
10912735|NCT00622180|EG000|Reported Event|Daavlin vs. Excilite|"Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.~Daavlin Spectra UVB Hand/Foot Box : Narrow-band ultraviolet B hand box~Excilite Focal 308-nm light : Excilite Focal 308-nm light"
10912736|NCT00622180|EG001|Reported Event|Excilite vs. Daavlin|"Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light~Excilite Focal 308-nm light : Excilite Focal 308-nm light~Daavlin Spectra UVB Hand/Foot Box : Narrow-band ultraviolet B hand box"
10912737|NCT00622284|BG000|Baseline|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
10912738|NCT00622284|BG001|Baseline|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
10912739|NCT00622284|BG002|Baseline|Total|Total of all reporting groups
10912740|NCT00622284|FG000|Participant Flow|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
10912741|NCT00622284|FG001|Participant Flow|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
10912742|NCT00622284|OG000|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
10912743|NCT00622284|OG001|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
10912744|NCT00622284|EG000|Reported Event|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
10912745|NCT00622284|EG001|Reported Event|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
10912746|NCT00622336|BG000|Baseline|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
10912747|NCT00622336|FG000|Participant Flow|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
10912748|NCT00622336|OG000|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
10912749|NCT00622336|OG000|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
10912750|NCT00622336|EG000|Reported Event|Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
10912751|NCT00622336|EG001|Reported Event|Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
10912752|NCT00622388|BG000|Baseline|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
10912753|NCT00622388|FG000|Participant Flow|Ofatumumab|Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg
10912754|NCT00622388|OG000|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
10912755|NCT00622388|OG000|Outcome|Overall Study Arm|
10912756|NCT00622388|EG000|Reported Event|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
10912757|NCT00622401|BG000|Baseline|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
10912758|NCT00622401|BG001|Baseline|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
10912759|NCT00622401|BG002|Baseline|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
10912760|NCT00622401|BG003|Baseline|Total|Total of all reporting groups
10912761|NCT00622401|FG000|Participant Flow|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
10912762|NCT00622401|FG001|Participant Flow|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
10912763|NCT00622401|FG002|Participant Flow|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
10912764|NCT00622401|OG000|Outcome|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
10912765|NCT00622401|OG000|Outcome|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
10912766|NCT00622401|OG001|Outcome|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
10912767|NCT00622401|OG002|Outcome|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
10912768|NCT00622401|EG000|Reported Event|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
10912769|NCT00622427|BG000|Baseline|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
10912770|NCT00622427|BG001|Baseline|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
10912771|NCT00622427|BG002|Baseline|Total|Total of all reporting groups
10912772|NCT00622427|FG000|Participant Flow|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
10912773|NCT00622427|FG001|Participant Flow|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
10912774|NCT00622427|OG000|Outcome|Ramelteon|QD for 14 days prior to sleep first
10912775|NCT00622427|OG001|Outcome|Placebo|QD for 14 days prior to sleep first
10912776|NCT00622427|OG000|Outcome|Ramelteon|QD for 14 days prior to sleep
10912777|NCT00622427|OG001|Outcome|Placebo|QD for 14 days prior to sleep
10912778|NCT00622427|EG000|Reported Event|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
10912779|NCT00622427|EG001|Reported Event|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
10912780|NCT00622440|BG000|Baseline|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
10912781|NCT00622440|BG001|Baseline|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
10912782|NCT00622440|BG002|Baseline|Total|Total of all reporting groups
10912783|NCT00622440|FG000|Participant Flow|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
10912784|NCT00622440|FG001|Participant Flow|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
10912785|NCT00622440|OG000|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
10912786|NCT00622440|OG001|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
10912787|NCT00622440|EG000|Reported Event|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
10912788|NCT00622440|EG001|Reported Event|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
10912789|NCT00622466|BG000|Baseline|Sorfenib + Paclitaxel|"Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15~paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma~sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma"
10912790|NCT00622466|FG000|Participant Flow|Sorfenib + Paclitaxel|"Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15~paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma~sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma"
10912791|NCT00622466|OG000|Outcome|Sorfenib + Paclitaxel|"Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15~paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma~sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma"
10912792|NCT00622466|EG000|Reported Event|Sorfenib + Paclitaxel|"Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15~paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma~sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma"
10912793|NCT00622505|BG000|Baseline|Zoledronic Acid Every 12 Weeks|Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( <50 nmol/mmol creatinine).
10912794|NCT00622505|BG001|Baseline|Zoledronic Acid Every 4 Weeks or 12 Weeks|Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or <50 nmol/mmol creatinine, respectively).
10912795|NCT00622505|BG002|Baseline|Total|Total of all reporting groups
10912796|NCT00622505|FG000|Participant Flow|Zoledronic Acid Every 12 Weeks|Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( <50 nmol/mmol creatinine).
10912797|NCT00622505|FG001|Participant Flow|Zoledronic Acid Every 4 Weeks or 12 Weeks|Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or <50 nmol/mmol creatinine, respectively).
10912798|NCT00622505|OG000|Outcome|Zoledronic Acid Every 12 Weeks|Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( <50 nmol/mmol creatinine).
10912799|NCT00622505|OG001|Outcome|Zoledronic Acid Every 4 Weeks or 12 Weeks|Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or <50 nmol/mmol creatinine, respectively).
11173380|NCT02015221|FG000|Participant Flow|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
11173381|NCT02015221|FG001|Participant Flow|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
11173382|NCT02015221|OG000|Outcome|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
11173383|NCT02015221|OG001|Outcome|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
11173384|NCT02015221|EG000|Reported Event|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
11173385|NCT02015221|EG001|Reported Event|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
11173386|NCT02015234|BG000|Baseline|Placebo - TNX-102 SL 2.8 mg|"1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months~TNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime."
11173387|NCT02015234|BG001|Baseline|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|"1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months~TNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime."
11173388|NCT02015234|BG002|Baseline|Total|Total of all reporting groups
11173389|NCT02015234|FG000|Participant Flow|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
11173390|NCT02015234|FG001|Participant Flow|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.
11173391|NCT02015234|OG000|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
11173392|NCT02015234|OG001|Outcome|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.
11173393|NCT02015234|OG001|Outcome|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
11173394|NCT02015234|OG001|Outcome|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
10912800|NCT00622505|EG000|Reported Event|Zoledronic Acid Every 12 Weeks|Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( <50 nmol/mmol creatinine).
11173395|NCT02015234|EG000|Reported Event|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
11173396|NCT02015234|EG001|Reported Event|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
11173397|NCT02015390|BG000|Baseline|Masquelet Defect Reconstruction|"The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect.~The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate."
11342189|NCT03700671|FG000|Participant Flow|High Intensity Interval Training|"High intensity interval training (HIIT) was set at > 85% HRmax. Active recovery was set at 25-50 watts. Sessions were performed using cycle ergometry.~High intensity interval training: Participants performed HIIT twice a week for eight weeks. Findings were compared to moderate intensity continuous training which followed the same exercise frequency and duration"
11173398|NCT02015390|BG001|Baseline|Titanium Cage Reconstruction|"The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft.~After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect."
10912801|NCT00622505|EG001|Reported Event|Zoledronic Acid Every 4 Weeks or 12 Weeks|Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or <50 nmol/mmol creatinine, respectively).
10912802|NCT00622518|BG000|Baseline|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
10912803|NCT00622518|BG001|Baseline|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
10912804|NCT00622518|BG002|Baseline|Total|Total of all reporting groups
10912805|NCT00622518|FG000|Participant Flow|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
10912806|NCT00622518|FG001|Participant Flow|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
10912807|NCT00622518|OG000|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
10912808|NCT00622518|OG001|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
11173399|NCT02015390|BG002|Baseline|Total|Total of all reporting groups
11173400|NCT02015390|FG000|Participant Flow|Masquelet Defect Reconstruction|"The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect.~The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate."
10912809|NCT00622518|EG000|Reported Event|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
10912810|NCT00622518|EG001|Reported Event|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
10912811|NCT00622544|BG000|Baseline|Observational Study: no Arms - One Group|Observational study of urine albumin and protein excretion in untreated boys with Alport syndrome
10912812|NCT00622544|FG000|Participant Flow|Observational Study: no Arms - One Group|Observational study of urine albumin and protein excretion in untreated boys with X-linked Alport syndrome
10912813|NCT00622544|OG000|Outcome|Observational Study: no Arms - One Group|Boys less than 18 years of age with a confirmed diagnosis of Alport syndrome
10912814|NCT00622544|EG000|Reported Event|Observational Study: no Arms - One Group|Observational study of urine albumin and protein excretion in untreated boys with Alport syndrome
10912815|NCT00622635|BG000|Baseline|Entire Study Population|The entire study population included all 6 treatment groups who received indacaterol 300 µg once daily, placebo to indacaterol once daily, and salmeterol 50 µg twice daily via a single-dose (indacaterol and placebo to indacaterol) or multi-dose (salmeterol) dry-powder inhaler in 6 different sequences. Patients received each treatment for 14 days with a 14 day washout between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912816|NCT00622635|FG000|Participant Flow|Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912817|NCT00622635|FG001|Participant Flow|Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912818|NCT00622635|FG002|Participant Flow|Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912819|NCT00622635|FG003|Participant Flow|Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912820|NCT00622635|FG004|Participant Flow|Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912821|NCT00622635|FG005|Participant Flow|Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912822|NCT00622635|OG000|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912823|NCT00622635|OG001|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11174301|NCT02020785|BG000|Baseline|Higher Phosphorus Period Then Lower Phosphorus Period|"Randomized to higher phosphorus period first, then lower phosphorus period second.~Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks~At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives~Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) given for 3 weeks~Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks"
10912824|NCT00622635|OG002|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912825|NCT00622635|EG000|Reported Event|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912826|NCT00622635|EG001|Reported Event|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912827|NCT00622635|EG002|Reported Event|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10912828|NCT00622700|BG000|Baseline|Placebo|Placebo matched to teriflunomide tablet once daily orally.
10912829|NCT00622700|BG001|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
10912830|NCT00622700|BG002|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
10912831|NCT00622700|BG003|Baseline|Total|Total of all reporting groups
10912832|NCT00622700|FG000|Participant Flow|Placebo|Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
10912833|NCT00622700|FG001|Participant Flow|Teriflunomide 7 mg|Core treatment period: Teriflunomide 7 mg tablet once daily orally.
10912834|NCT00622700|FG002|Participant Flow|Teriflunomide 14 mg|Core treatment period: Teriflunomide 14 mg tablet once daily orally.
10912835|NCT00622700|FG003|Participant Flow|Placebo/ Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
11173401|NCT02015390|FG001|Participant Flow|Titanium Cage Reconstruction|"The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft.~After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect."
11173402|NCT02015390|OG000|Outcome|Masquelet Defect Reconstruction|"The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect.~The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate."
11173403|NCT02015390|OG001|Outcome|Titanium Cage Reconstruction|"The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft.~After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect."
11173404|NCT02015390|OG001|Outcome|Titanium Cage Reconstruction|"The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft.~After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provides a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect."
11173405|NCT02015390|EG000|Reported Event|Masquelet Defect Reconstruction|The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane about a poly(methylmethacrylate)(PMMA) cement spacer within the defect and, following cement removal, autogenous bone grafting (harvested using Reamer-Irrigator-Aspirator) or allogeneic bone graft is used to pack the defect while preserving the biomembrane. The typical time interval between the two stages is 6-8 weeks. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect.
11173406|NCT02015390|EG001|Reported Event|Titanium Cage Reconstruction|The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft.
11173407|NCT02015442|BG000|Baseline|All Participants|All participants, cross-over study
11173408|NCT02015442|FG000|Participant Flow|High Sucrose Diet Then Low Sucrose|High sucrose diet for 7 days, then low sucrose diet
11173409|NCT02015442|FG001|Participant Flow|Low Sucrose Diet Then High Sucrose|Low sucrose diet for 7 days for first intervention, then high sucrose
11173410|NCT02015442|OG000|Outcome|High Sucrose Diet|High sucrose diet for 7 days
11173411|NCT02015442|OG001|Outcome|Low Sucrose Diet|Low sucrose diet for 7 days
11173412|NCT02015442|EG000|Reported Event|High Sucrose Diet|High sucrose diet for 7 days
11173413|NCT02015442|EG001|Reported Event|Low Sucrose Diet|Low sucrose diet for 7 days
11173414|NCT02015481|BG000|Baseline|Cabaletta 30gr.|"weekly IV of Cabaletta 30gr.~Cabaletta"
11173415|NCT02015481|FG000|Participant Flow|Cabaletta 30gr|"weekly IV of Cabaletta 30gr~Cabaletta"
11173416|NCT02015481|OG000|Outcome|Cabaletta 30gr.|"weekly IV of Cabaletta 30gr.~Cabaletta"
11173417|NCT02015481|OG000|Outcome|Cabaletta 30gr|"weekly IV of Cabaletta 30gr~Cabaletta"
11173418|NCT02015481|EG000|Reported Event|Cabaletta 30gr|"weekly IV of Cabaletta 30gr~Cabaletta"
11173419|NCT02015520|BG000|Baseline|Placebo + Methotrexate (MTX)|Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
10912836|NCT00622700|FG004|Participant Flow|Teriflunomide 7 mg/7 mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
10912837|NCT00622700|FG005|Participant Flow|Placebo/Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
10912838|NCT00622700|FG006|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
10912839|NCT00622700|OG000|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
10912840|NCT00622700|OG001|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
10912841|NCT00622700|OG002|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
10912842|NCT00622700|OG000|Outcome|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
10912843|NCT00622700|OG001|Outcome|Teriflunomide 7 mg/ 7mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
10912844|NCT00622700|OG002|Outcome|Placebo/ Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
10912845|NCT00622700|OG003|Outcome|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
10912846|NCT00622700|OG001|Outcome|Teriflunomide 7 mg/ 7mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
10912847|NCT00622700|EG000|Reported Event|Placebo|Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
10912848|NCT00622700|EG001|Reported Event|Teriflunomide 7 mg|Core treatment period: Teriflunomide 7 mg tablet once daily orally.
10912849|NCT00622700|EG002|Reported Event|Teriflunomide 14 mg|Core treatment period: Teriflunomide 14 mg tablet once daily orally.
10912850|NCT00622700|EG003|Reported Event|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
10912851|NCT00622700|EG004|Reported Event|Teriflunomide 7 mg/7 mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
10912852|NCT00622700|EG005|Reported Event|Placebo/Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
10912853|NCT00622700|EG006|Reported Event|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
10912854|NCT00622713|BG000|Baseline|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
10912855|NCT00622713|FG000|Participant Flow|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
10912856|NCT00622713|OG000|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
10912857|NCT00622713|EG000|Reported Event|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
10912858|NCT00622726|BG000|Baseline|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
10912859|NCT00622726|BG001|Baseline|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
10912860|NCT00622726|BG002|Baseline|Total|Total of all reporting groups
10912861|NCT00622726|FG000|Participant Flow|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
10912862|NCT00622726|FG001|Participant Flow|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
10912863|NCT00622726|OG000|Outcome|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients/62 eyes had zone I ROP; 39 patients/78 eyes had zone II posterior ROP.
10912864|NCT00622726|OG001|Outcome|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients/66 eyes had zone I ROP; 40 patients/80 eyes had posterior zone II ROP.
10912865|NCT00622726|OG000|Outcome|Bevacizumab-Experimental Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Zone I.
10912866|NCT00622726|OG001|Outcome|Conventional Laser-Control Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Zone I.
10912867|NCT00622726|OG002|Outcome|Bevacizumab Experimental Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Posterior Zone II.
10912868|NCT00622726|OG003|Outcome|Conventional Laser-Control Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Posterior Zone II.
10912869|NCT00622726|EG000|Reported Event|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
10912870|NCT00622726|EG001|Reported Event|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
10912871|NCT00622739|BG000|Baseline|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
10912872|NCT00622739|BG001|Baseline|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
11173420|NCT02015520|BG001|Baseline|Clazakizumab (1 mg) + MTX|Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
10912873|NCT00622739|BG002|Baseline|Total|Total of all reporting groups
10912874|NCT00622739|FG000|Participant Flow|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
11173421|NCT02015520|BG002|Baseline|Clazakizumab (5 mg) + MTX|Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
10912875|NCT00622739|FG001|Participant Flow|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
10912876|NCT00622739|OG000|Outcome|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
10912877|NCT00622739|OG001|Outcome|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
10912878|NCT00622739|OG000|Outcome|Ziprasidone Rapid Dose|Rapid dose titration group
10912879|NCT00622739|OG001|Outcome|Ziprasidone Slow Dose|Slow dose titration group
10912880|NCT00622739|EG000|Reported Event|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
10912881|NCT00622739|EG001|Reported Event|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
10912882|NCT00622869|BG000|Baseline|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
10912883|NCT00622869|BG001|Baseline|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
10912884|NCT00622869|BG002|Baseline|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
10912885|NCT00622869|BG003|Baseline|Total|Total of all reporting groups
10912886|NCT00622869|FG000|Participant Flow|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
10912887|NCT00622869|FG001|Participant Flow|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
10912888|NCT00622869|FG002|Participant Flow|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
10912889|NCT00622869|OG000|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
10912890|NCT00622869|OG001|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
10912891|NCT00622869|OG002|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
10912892|NCT00622869|EG000|Reported Event|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids
11173422|NCT02015520|BG003|Baseline|Clazakizumab (25 mg) + MTX|Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
11173423|NCT02015520|BG004|Baseline|Total|Total of all reporting groups
10912893|NCT00622869|EG001|Reported Event|Tacrolimus Elimination|Low dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids
10912894|NCT00622869|EG002|Reported Event|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids
10912895|NCT00622895|BG000|Baseline|Treatment: Allogeneic HCT After Reduced Intensity Conditioning|"Conditioning regimen~Day -6: cyclophosphamide 50mg/kg. MESNA will be given for bladder prophylaxis .~Day -6, -5, -4: Horse ATG 30mg/kg IV x 3 days.~Days -6, -5, -4, -3 and -2: Fludarabine 40 mg/m2/day IV over one hour x 5 days.~Day -1: TBI 200 cGy at 6-7 cGy/min from a linear accelerator TBI.~Day 0: UCB infusion ( 2 units)~Day -3: Commence tacrolimus at 0.03 mg/kg/day continuous IV infusion until the patient is tolerating oral intake then convert to oral PO b.i.d., continue to day +180 and taper to day +365.~Day 0: After UCB transplant on day 0, mycophenolate mofetil will be given 1gm IV t.i.d. until the patient is tolerating oral intake and can convert to 1 gram PO T.I.D. Stop MMF at Day +30, if no acute GVHD, until day +100, and then taper 11% week over 8 weeks."
10912896|NCT00622895|FG000|Participant Flow|Treatment: Allogeneic HCT After Reduced Intensity Conditioning|"Conditioning regimen~Day -6: cyclophosphamide 50mg/kg. MESNA will be given for bladder prophylaxis .~Day -6, -5, -4: Horse ATG 30mg/kg IV x 3 days.~Days -6, -5, -4, -3 and -2: Fludarabine 40 mg/m2/day IV over one hour x 5 days.~Day -1: TBI 200 cGy at 6-7 cGy/min from a linear accelerator TBI.~Day 0: UCB infusion ( 2 units)~Day -3: Commence tacrolimus at 0.03 mg/kg/day continuous IV infusion until the patient is tolerating oral intake then convert to oral PO b.i.d., continue to day +180 and taper to day +365.~Day 0: After UCB transplant on day 0, mycophenolate mofetil will be given 1gm IV t.i.d. until the patient is tolerating oral intake and can convert to 1 gram PO T.I.D. Stop MMF at Day +30, if no acute GVHD, until day +100, and then taper 11% week over 8 weeks."
10912897|NCT00622895|OG000|Outcome|Treatment: Allogeneic HCT After Reduced Intensity Conditioning|"Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid.~fludarabine phosphate: Given IV~Mycophenolic Acid: Given PO~tacrolimus: Given PO~total-body irradiation: Undergo TBI~bone marrow transplantation: Undergo transplantation~reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~biopsy: Punch biopsy of skin involved with scleroderma~cyclophosphamide: Given IV"
10912898|NCT00622895|OG000|Outcome|Treatment: Allogeneic UCB After Reduced Intensity Conditioning|"Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive hematopoietic cell transplantation on day 0.~fludarabine phosphate: Given IV~Mycophenolic Acid: Given PO~tacrolimus: Given PO~total-body irradiation: Undergo TBI~bone marrow transplantation: Undergo transplantation~reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~biopsy: Punch biopsy of skin involved with scleroderma"
10912899|NCT00622895|OG000|Outcome|Treatment: Allogeneic HCT After Reduced Intensity Conditioning|"Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid.~fludarabine phosphate: Given IV~Mycophenolic Acid: Given PO~tacrolimus: Given PO~total-body irradiation: Undergo TBI~bone marrow transplantation: Undergo transplantation~reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation~cyclophosphamide: Given IV"
10912900|NCT00622895|OG000|Outcome|Treatment: Allogeneic HCT After Reduced Intensity Conditioning|"Conditioning regimen~Day -6: cyclophosphamide 50mg/kg. MESNA will be given for bladder prophylaxis .~Day -6, -5, -4: Horse ATG 30mg/kg IV x 3 days.~Days -6, -5, -4, -3 and -2: Fludarabine 40 mg/m2/day IV over one hour x 5 days.~Day -1: TBI 200 cGy at 6-7 cGy/min from a linear accelerator TBI.~Day 0: UCB infusion ( 2 units)~Day -3: Commence tacrolimus at 0.03 mg/kg/day continuous IV infusion until the patient is tolerating oral intake then convert to oral PO b.i.d., continue to day +180 and taper to day +365.~Day 0: After UCB transplant on day 0, mycophenolate mofetil will be given 1gm IV t.i.d. until the patient is tolerating oral intake and can convert to 1 gram PO T.I.D. Stop MMF at Day +30, if no acute GVHD, until day +100, and then taper 11% week over 8 weeks."
10912901|NCT00622895|EG000|Reported Event|Treatment: Allogeneic HCT After Reduced Intensity Conditioning|"Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid.~fludarabine phosphate: Given IV~Mycophenolic Acid: Given PO~tacrolimus: Given PO~total-body irradiation: Undergo TBI~bone marrow transplantation: Undergo transplantation~reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~biopsy: Punch biopsy of skin involved with scleroderma~cyclophosphamide: Given IV"
10912902|NCT00622908|BG000|Baseline|ISV-403|0.6% ISV-403
11173424|NCT02015520|FG000|Participant Flow|Placebo + Methotrexate (MTX)|Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
10912903|NCT00622908|BG001|Baseline|Vehicle|Vehicle of ISV-403
10912904|NCT00622908|BG002|Baseline|Total|Total of all reporting groups
10912905|NCT00622908|FG000|Participant Flow|ISV-403|0.6% ISV-403
10912906|NCT00622908|FG001|Participant Flow|Vehicle|Vehicle of ISV-403
10912907|NCT00622908|OG000|Outcome|ISV-403|0.6% ISV-403
10912908|NCT00622908|OG001|Outcome|Vehicle|Vehicle of ISV-403
10912909|NCT00622908|EG000|Reported Event|ISV-403|0.6% ISV-403
10912910|NCT00622908|EG001|Reported Event|Vehicle|Vehicle of ISV-403
11173425|NCT02015520|FG001|Participant Flow|Clazakizumab (1 mg) + MTX|Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
10912911|NCT00623012|BG000|Baseline|Rapamycin Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
10912912|NCT00623012|FG000|Participant Flow|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
10912913|NCT00623012|OG000|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
10912914|NCT00623012|EG000|Reported Event|Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
10912915|NCT00623103|BG000|Baseline|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
11173426|NCT02015520|FG002|Participant Flow|Clazakizumab (5 mg) + MTX|Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
10912916|NCT00623103|BG001|Baseline|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
10912917|NCT00623103|BG002|Baseline|Total|Total of all reporting groups
10912918|NCT00623103|FG000|Participant Flow|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
10912919|NCT00623103|FG001|Participant Flow|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
10912920|NCT00623103|OG000|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
10912921|NCT00623103|OG001|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
10912922|NCT00623103|EG000|Reported Event|Exelon Capsule|Exelon Capsule
11173427|NCT02015520|FG003|Participant Flow|Clazakizumab (25 mg) + MTX|Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
11173428|NCT02015520|OG000|Outcome|Placebo + Methotrexate (MTX)|Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
10912923|NCT00623103|EG001|Reported Event|Exelon Patch|Exelon Patch
10912924|NCT00623181|BG000|Baseline|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
11173429|NCT02015520|OG001|Outcome|Clazakizumab (1 mg) + MTX|Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
11173430|NCT02015520|OG002|Outcome|Clazakizumab (5 mg) + MTX|Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
11173431|NCT02015520|OG003|Outcome|Clazakizumab (25 mg) + MTX|Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
10912925|NCT00623181|BG001|Baseline|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
10912926|NCT00623181|BG002|Baseline|Total|Total of all reporting groups
10912927|NCT00623181|FG000|Participant Flow|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
10912928|NCT00623181|FG001|Participant Flow|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
10912929|NCT00623181|OG000|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
10912930|NCT00623181|OG001|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
10912931|NCT00623181|OG000|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0.
10912932|NCT00623181|OG001|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0.
10912933|NCT00623181|OG000|Outcome|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
10912934|NCT00623181|OG001|Outcome|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
10912935|NCT00623181|EG000|Reported Event|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
10912936|NCT00623181|EG001|Reported Event|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
10912937|NCT00623194|BG000|Baseline|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
10912938|NCT00623194|FG000|Participant Flow|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
11091661|NCT01535924|BG000|Baseline|Phase 1 (Dose Levels 1)|"Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV"
11091662|NCT01535924|BG001|Baseline|Phase 1 (Dose Levels 2)|Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10912939|NCT00623194|OG000|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
10912940|NCT00623194|EG000|Reported Event|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
10912941|NCT00623233|BG000|Baseline|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
11091663|NCT01535924|BG002|Baseline|Phase 1 (Dose Levels 3)|Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11091664|NCT01535924|BG003|Baseline|Phase 1 (Dose Levels 4)|Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11091665|NCT01535924|BG004|Baseline|Phase 2 (Dose Levels 5)|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
11091666|NCT01535924|BG005|Baseline|Phase 2|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
11091667|NCT01535924|BG006|Baseline|Total|Total of all reporting groups
10912942|NCT00623233|FG000|Participant Flow|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
10912943|NCT00623233|OG000|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
10912944|NCT00623233|EG000|Reported Event|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
11173432|NCT02015520|EG000|Reported Event|Placebo + Methotrexate (MTX)|Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
10912945|NCT00623363|BG000|Baseline|Placebo|Participants with Parkinson's disease who were administered two 12-hour IV infusions of 0.9% sodium chloride (normal saline) placebo over 2 inpatient days.
10912946|NCT00623363|BG001|Baseline|SUN N4057|Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
10912947|NCT00623363|BG002|Baseline|Total|Total of all reporting groups
10912948|NCT00623363|FG000|Participant Flow|Placebo|Participants with Parkinson's disease who were administered two 12-hour IV infusions of 0.9% sodium chloride (normal saline) placebo over 2 inpatient days.
10912949|NCT00623363|FG001|Participant Flow|SUN N4057|Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
10912950|NCT00623363|OG000|Outcome|Placebo|Participants with Parkinson's disease who were administered two 12-hour IV infusions of 0.9% sodium chloride (normal saline) placebo over 2 inpatient days.
10912951|NCT00623363|OG001|Outcome|SUN N4057|Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
10912952|NCT00623363|OG000|Outcome|SUN N4057|Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
10912953|NCT00623363|EG000|Reported Event|Placebo|Participants with Parkinson's disease who were administered two 12-hour IV infusions of 0.9% sodium chloride (normal saline) placebo over 2 inpatient days.
10912954|NCT00623363|EG001|Reported Event|SUN N4057|Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
10912955|NCT00623428|BG000|Baseline|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
10912956|NCT00623428|BG001|Baseline|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
10912957|NCT00623428|BG002|Baseline|Total|Total of all reporting groups
10912958|NCT00623428|FG000|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
10912959|NCT00623428|FG001|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
10912960|NCT00623428|OG000|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
10912961|NCT00623428|OG001|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
10912962|NCT00623428|EG000|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
10912963|NCT00623428|EG001|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
10912964|NCT00623441|BG000|Baseline|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
10912965|NCT00623441|FG000|Participant Flow|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
10912966|NCT00623441|OG000|Outcome|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
10912967|NCT00623441|EG000|Reported Event|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
10912968|NCT00623467|BG000|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
10912969|NCT00623467|FG000|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
10912970|NCT00623467|OG000|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
10912971|NCT00623467|OG001|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
10912972|NCT00623467|OG000|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
10912973|NCT00623467|EG000|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
10912974|NCT00623480|BG000|Baseline|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
10912975|NCT00623480|BG001|Baseline|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
10912976|NCT00623480|BG002|Baseline|Total|Total of all reporting groups
11091668|NCT01535924|FG000|Participant Flow|Phase 1 (Dose Level 1)|Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10912977|NCT00623480|FG000|Participant Flow|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
10912978|NCT00623480|FG001|Participant Flow|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
10912979|NCT00623480|OG000|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
10912980|NCT00623480|OG001|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
10912981|NCT00623480|EG000|Reported Event|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
10912982|NCT00623480|EG001|Reported Event|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
10912983|NCT00623506|BG000|Baseline|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
10912984|NCT00623506|BG001|Baseline|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
10912985|NCT00623506|BG002|Baseline|Total|Total of all reporting groups
10912986|NCT00623506|FG000|Participant Flow|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
10912987|NCT00623506|FG001|Participant Flow|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
10912988|NCT00623506|OG000|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
10912989|NCT00623506|OG001|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
10912990|NCT00623506|EG000|Reported Event|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
10912991|NCT00623506|EG001|Reported Event|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
10912992|NCT00623545|BG000|Baseline|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcomes are performed before and at the end of treatment. Outcomes are based on the change in the variables.
10912993|NCT00623545|FG000|Participant Flow|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcome variables are made before treatment and again at the end of the1 treatment period made. Outcomes are based on the change in these variables.
10912994|NCT00623545|OG000|Outcome|Exenitide Treatment|There is one treatment arm. Subjects serve as their own controls for the outcome measure. The measures are made before the treatment is started at during the end of the treatment.
10912995|NCT00623545|OG000|Outcome|Exenitide Treatment|
10912996|NCT00623545|EG000|Reported Event|Single Arm Study of Exenatide Treatment|
10912997|NCT00623597|BG000|Baseline|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10912998|NCT00623597|BG001|Baseline|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10912999|NCT00623597|BG002|Baseline|Total|Total of all reporting groups
10913000|NCT00623597|FG000|Participant Flow|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10913001|NCT00623597|FG001|Participant Flow|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10913002|NCT00623597|OG000|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10913003|NCT00623597|OG001|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10913004|NCT00623597|OG002|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10913005|NCT00623597|EG000|Reported Event|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10913006|NCT00623597|EG001|Reported Event|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
11091669|NCT01535924|FG001|Participant Flow|Phase 1 (Dose Level 2)|Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10913007|NCT00623597|EG002|Reported Event|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
10913008|NCT00623623|BG000|Baseline|Tenecteplase (Group A)|Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
10913009|NCT00623623|BG001|Baseline|Primary PCI (Group B)|"Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.~Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines."
10913010|NCT00623623|BG002|Baseline|Total|Total of all reporting groups
10913011|NCT00623623|FG000|Participant Flow|Tenecteplase (Group A)|Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
10913012|NCT00623623|FG001|Participant Flow|Primary PCI (Group B)|"Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.~Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines."
10913013|NCT00623623|OG000|Outcome|Tenecteplase (Group A)|Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
10913014|NCT00623623|OG001|Outcome|Primary PCI (Group B)|"Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.~Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines."
10913015|NCT00623623|EG000|Reported Event|Tenecteplase (Group A)|Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
10913016|NCT00623623|EG001|Reported Event|Primary PCI (Group B)|"Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.~Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines."
10913017|NCT00623636|BG000|Baseline|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
10913018|NCT00623636|BG001|Baseline|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
10913019|NCT00623636|BG002|Baseline|Total|Total of all reporting groups
10913020|NCT00623636|FG000|Participant Flow|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
10913021|NCT00623636|FG001|Participant Flow|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
10913022|NCT00623636|OG000|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
10913023|NCT00623636|OG001|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
10913024|NCT00623636|EG000|Reported Event|Double-blind Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
10913025|NCT00623636|EG001|Reported Event|Double-blind MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
10913026|NCT00623636|EG002|Reported Event|Open-label MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
10913027|NCT00623714|BG000|Baseline|All Patients|All Randomized Patients
10913028|NCT00623714|FG000|Participant Flow|Placebo Then Fluticasone|Days 1-2 Placebo twice a Day (b.i.d.) + Day 3 Placebo single dose, Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
10913029|NCT00623714|FG001|Participant Flow|Fluticasone Then Placebo|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose, Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
10913030|NCT00623714|OG000|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
10913031|NCT00623714|OG001|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
10913032|NCT00623714|EG000|Reported Event|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
10913033|NCT00623714|EG001|Reported Event|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
10913034|NCT00623727|BG000|Baseline|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
11091670|NCT01535924|FG002|Participant Flow|Phase 1 (Dose Level 3)|Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11091671|NCT01535924|FG003|Participant Flow|Phase 1 (Dose Level 4)|Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11173433|NCT02015520|EG001|Reported Event|Clazakizumab (1 mg) + MTX|Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
10913035|NCT00623727|BG001|Baseline|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
10913036|NCT00623727|BG002|Baseline|Total|Total of all reporting groups
10913037|NCT00623727|FG000|Participant Flow|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
10913038|NCT00623727|FG001|Participant Flow|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
10913039|NCT00623727|OG000|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
10913040|NCT00623727|OG001|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
10913041|NCT00623727|EG000|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Double Blind|Reporting Group 1 (RG1): Double Blind Study, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
10913042|NCT00623727|EG001|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Double Blind|Reporting group 2 (RG2): Double Blind Study, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
10913043|NCT00623727|EG002|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Follow-up|Reporting group 3 (RG3): Open Label Follow-up, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
10913044|NCT00623727|EG003|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Extension|Reporting group 4 (RG4): Open Label Extension, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
11091672|NCT01535924|FG004|Participant Flow|Phase 2 (Dose Level 5)|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
10913045|NCT00623766|BG000|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
11091673|NCT01535924|FG005|Participant Flow|Phase 2|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
11091674|NCT01535924|OG000|Outcome|Phase 1 (Dose Levels 1)|"Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV"
11091675|NCT01535924|OG001|Outcome|Phase 1 (Dose Levels 2)|Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10913046|NCT00623766|BG001|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913047|NCT00623766|BG002|Baseline|Total|Total of all reporting groups
11091676|NCT01535924|OG002|Outcome|Phase 1 (Dose Levels 3)|Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10913048|NCT00623766|FG000|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913049|NCT00623766|FG001|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913050|NCT00623766|OG000|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913051|NCT00623766|OG001|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913052|NCT00623766|OG000|Outcome|Ipilimumab 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913053|NCT00623766|OG001|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913054|NCT00623766|OG000|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients|"Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.~Ipilimumab: 10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance"
10913055|NCT00623766|OG001|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
11091677|NCT01535924|OG003|Outcome|Phase 1 (Dose Levels 4)|Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11091678|NCT01535924|OG004|Outcome|Phase 2 (Dose Levels 5)|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
11091679|NCT01535924|OG005|Outcome|Phase 2|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
11091680|NCT01535924|OG005|Outcome|Phase 2|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle
11091681|NCT01535924|EG000|Reported Event|Phase 1 (Dose Levels 1)|"Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gemcitabine hydrochloride: Given IV~bendamustine hydrochloride: Given IV"
11091682|NCT01535924|EG001|Reported Event|Phase 1 (Dose Levels 2)|Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11091683|NCT01535924|EG002|Reported Event|Phase 1 (Dose Levels 3)|Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11091684|NCT01535924|EG003|Reported Event|Phase 1 (Dose Levels 4)|Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11091685|NCT01535924|EG004|Reported Event|Phase 2 (Dose Levels 5)|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
11091686|NCT01535924|EG005|Reported Event|Phase 2|Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
11091687|NCT01535937|BG000|Baseline|Ketamine|"0.5 mg/kg of ketamine IV over 40 minutes~Ketamine: 0.5 mg/kg IV over 40 minutes"
11091688|NCT01535937|BG001|Baseline|Midazolam|"0.025 mg/kg IV over 40 minutes~Midazolam: 0.025 mg/kg IV over 40 minutes"
11091689|NCT01535937|BG002|Baseline|Total|Total of all reporting groups
11091690|NCT01535937|FG000|Participant Flow|Ketamine|"0.5 mg/kg of ketamine IV over 40 minutes~Ketamine: 0.5 mg/kg IV over 40 minutes"
11091691|NCT01535937|FG001|Participant Flow|Midazolam|"0.025 mg/kg IV over 40 minutes~Midazolam: 0.025 mg/kg IV over 40 minutes"
11091692|NCT01535937|OG000|Outcome|Ketamine|"0.5 mg/kg of ketamine IV over 40 minutes~Ketamine: 0.5 mg/kg IV over 40 minutes"
11091693|NCT01535937|OG001|Outcome|Midazolam|"0.025 mg/kg IV over 40 minutes~Midazolam: 0.025 mg/kg IV over 40 minutes"
11091694|NCT01535937|EG000|Reported Event|Ketamine|"0.5 mg/kg of ketamine IV over 40 minutes~Ketamine: 0.5 mg/kg IV over 40 minutes"
11091695|NCT01535937|EG001|Reported Event|Midazolam|"0.025 mg/kg IV over 40 minutes~Midazolam: 0.025 mg/kg IV over 40 minutes"
11091696|NCT01535976|BG000|Baseline|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min"
10913056|NCT00623766|EG000|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913057|NCT00623766|EG001|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
10913058|NCT00623779|BG000|Baseline|AZD0837 150 mg|AZD0837 150 mg
10913059|NCT00623779|BG001|Baseline|AZD0837 300 mg|AZD0837 300 mg
10913060|NCT00623779|BG002|Baseline|Standard Therapy|Standard Therapy
10913061|NCT00623779|BG003|Baseline|Total|Total of all reporting groups
10913062|NCT00623779|FG000|Participant Flow|AZD0837 150 mg|AZD0837 150 mg
10913063|NCT00623779|FG001|Participant Flow|AZD0837 300 mg|AZD0837 300 mg
10913064|NCT00623779|FG002|Participant Flow|Standard Therapy|Standard Therapy
10913065|NCT00623779|OG000|Outcome|AZD0837 150 mg|AZD0837 150 mg
10913066|NCT00623779|OG001|Outcome|AZD0837 300 mg|AZD0837 300 mg
10913067|NCT00623779|OG002|Outcome|Standard Therapy|Standard Therapy
10913068|NCT00623779|EG000|Reported Event|AZD0837 150 mg|AZD0837 150 mg
10913069|NCT00623779|EG001|Reported Event|AZD0837 300 mg|AZD0837 300 mg
10913070|NCT00623779|EG002|Reported Event|Standard Therapy|Standard Therapy
10913071|NCT00623805|BG000|Baseline|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
10913072|NCT00623805|BG001|Baseline|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
10913073|NCT00623805|BG002|Baseline|Total|Total of all reporting groups
10913074|NCT00623805|FG000|Participant Flow|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
10913075|NCT00623805|FG001|Participant Flow|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
10913076|NCT00623805|OG000|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
10913077|NCT00623805|OG001|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
10913078|NCT00623805|EG000|Reported Event|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
10913079|NCT00623805|EG001|Reported Event|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
10913080|NCT00623831|BG000|Baseline|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
10913081|NCT00623831|BG001|Baseline|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
10913082|NCT00623831|BG002|Baseline|Total|Total of all reporting groups
10913083|NCT00623831|FG000|Participant Flow|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a dose-limiting toxicity (DLT) until the desired pyrogenic effect was observed.
11091697|NCT01535976|BG001|Baseline|Placebo|"normal saline infusion~Placebo : Placebo Comparator: Placebo~normal saline infusion along with propofol 100 mcg/kg/min"
11091698|NCT01535976|BG002|Baseline|Total|Total of all reporting groups
11091699|NCT01535976|FG000|Participant Flow|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
10913084|NCT00623831|FG001|Participant Flow|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
10913085|NCT00623831|OG000|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
10913086|NCT00623831|OG001|Outcome|Cohort 2 (Safety Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
10913087|NCT00623831|OG000|Outcome|Cohort 1 (Immune Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
10913088|NCT00623831|OG000|Outcome|Cohort 1 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
10913089|NCT00623831|OG001|Outcome|Cohort 2 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
10913090|NCT00623831|EG000|Reported Event|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
10913091|NCT00623831|EG001|Reported Event|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
10913092|NCT00623935|BG000|Baseline|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
10913093|NCT00623935|FG000|Participant Flow|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
10913094|NCT00623935|OG000|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
10913095|NCT00623935|EG000|Reported Event|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
10913096|NCT00624013|BG000|Baseline|Placebo Comparator: Placebo|Placebo: 50 mg up to 100 mg daily for 6 months
10913097|NCT00624013|BG001|Baseline|Active Comparator: Sertraline|sertraline: 50 mg up to 100 mg daily for 6 months
10913098|NCT00624013|BG002|Baseline|Total|Total of all reporting groups
10913099|NCT00624013|FG000|Participant Flow|Placebo Comparator:Placebo|Placebo: 50 mg up to 100 mg daily for 6 months
10913100|NCT00624013|FG001|Participant Flow|Active Comparator: Sertraline|sertraline: 50 mg up to 100 mg daily for 6 months
10913101|NCT00624013|OG000|Outcome|Placebo|Placebo Comparator: 50 mg up to 100 mg daily for 6 months
10913102|NCT00624013|OG001|Outcome|Sertraline|sertraline: 50 mg up to 100 mg daily for 6 months
10913103|NCT00624013|OG000|Outcome|Placebo|Placebo 50 mg up to 100 mg daily for 6 months
10913104|NCT00624013|OG001|Outcome|Sertraline (Zoloft)|Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months
10913105|NCT00624013|EG000|Reported Event|Placebo|Placebo Comparator: 50 mg up to 100 mg daily for 6 months
10913106|NCT00624013|EG001|Reported Event|Sertraline|sertraline: 50 mg up to 100 mg daily for 6 months
10913107|NCT00624052|BG000|Baseline|Telmisartan 40mg and Amlodipine 10mg|
10913108|NCT00624052|BG001|Baseline|Randomised Telmisartan 80mg and Amlodipine 10mg|
10913109|NCT00624052|BG002|Baseline|Titrated Telmisartan 80mg and Amlodipine 10mg|
10913110|NCT00624052|BG003|Baseline|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
10913111|NCT00624052|BG004|Baseline|Total|Total of all reporting groups
10913112|NCT00624052|FG000|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit
10913113|NCT00624052|FG001|Participant Flow|Randomised Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
10913114|NCT00624052|FG002|Participant Flow|Titrated Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
10913115|NCT00624052|FG003|Participant Flow|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit
10913116|NCT00624052|OG000|Outcome|Telmisartan 40mg and Amlodipine 10mg|
10913117|NCT00624052|OG001|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
10913118|NCT00624052|OG002|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
10913119|NCT00624052|OG003|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
10913120|NCT00624052|OG000|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
10913121|NCT00624052|OG001|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
10913122|NCT00624052|OG002|Outcome|Pre-antihypertensive: Total|
10913123|NCT00624052|OG000|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
10913124|NCT00624052|OG001|Outcome|Pre-titration: No (DBP>=90 mmHg)|
11173434|NCT02015520|EG002|Reported Event|Clazakizumab (5 mg) + MTX|Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
11173435|NCT02015520|EG003|Reported Event|Clazakizumab (25 mg) + MTX|Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
10913125|NCT00624052|OG002|Outcome|Pre-titration: Total|
10913126|NCT00624052|EG000|Reported Event|Telmisartan 40mg and Amlodipine 10mg|The 838 participants in the telmisartan 40mg/amlodipine 10mg group includes all participants
10913127|NCT00624052|EG001|Reported Event|Telmisartan 80mg and Amlodipine 10mg|The 611 participants in the telmisartan 80mg/amlodipine 10mg (T80/A10) group include 436 patients in the randomised T80/A10 group + 91 patients in the uptitrated T80/A10 group + XX patients in the T80/A10 + add-on group
10913128|NCT00624065|BG000|Baseline|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
10913129|NCT00624065|BG001|Baseline|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
10913130|NCT00624065|BG002|Baseline|Total|Total of all reporting groups
10913131|NCT00624065|FG000|Participant Flow|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
10913132|NCT00624065|FG001|Participant Flow|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
10913133|NCT00624065|OG000|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
10913134|NCT00624065|OG001|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
10913135|NCT00624065|EG000|Reported Event|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
10913136|NCT00624065|EG001|Reported Event|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
10913137|NCT00624195|BG000|Baseline|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
10913138|NCT00624195|BG001|Baseline|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
10913139|NCT00624195|BG002|Baseline|Total|Total of all reporting groups
10913140|NCT00624195|FG000|Participant Flow|CNS-targeted|"CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, under dosing).~Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
11173436|NCT02015546|BG000|Baseline|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
11173437|NCT02015546|BG001|Baseline|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
10913141|NCT00624195|FG001|Participant Flow|Non-CNS-targeted|"Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.~Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
10913142|NCT00624195|OG000|Outcome|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
10913143|NCT00624195|OG001|Outcome|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
10913144|NCT00624195|EG000|Reported Event|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
10913145|NCT00624195|EG001|Reported Event|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
10913146|NCT00624221|BG000|Baseline|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
11173438|NCT02015546|BG002|Baseline|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
11173439|NCT02015546|BG003|Baseline|Total|Total of all reporting groups
11173440|NCT02015546|FG000|Participant Flow|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
11173441|NCT02015546|FG001|Participant Flow|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
11173442|NCT02015546|FG002|Participant Flow|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
10913147|NCT00624221|BG001|Baseline|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
10913148|NCT00624221|BG002|Baseline|Total|Total of all reporting groups
10913149|NCT00624221|FG000|Participant Flow|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
10913150|NCT00624221|FG001|Participant Flow|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
10913151|NCT00624221|OG000|Outcome|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
10913152|NCT00624221|OG001|Outcome|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
10913153|NCT00624221|EG000|Reported Event|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
10913154|NCT00624221|EG001|Reported Event|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
10913155|NCT00624286|BG000|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10913156|NCT00624286|BG001|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10913157|NCT00624286|BG002|Baseline|Total|Total of all reporting groups
10913158|NCT00624286|FG000|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10913159|NCT00624286|FG001|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11173443|NCT02015546|OG000|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
11173444|NCT02015546|OG001|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
11173445|NCT02015546|OG002|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
11173446|NCT02015546|EG000|Reported Event|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
10913160|NCT00624286|OG000|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10913161|NCT00624286|OG001|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10913162|NCT00624286|EG000|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11173447|NCT02015546|EG001|Reported Event|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
10913163|NCT00624286|EG001|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10913164|NCT00624338|BG000|Baseline|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913165|NCT00624338|BG001|Baseline|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
11173448|NCT02015546|EG002|Reported Event|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
11173449|NCT02015637|BG000|Baseline|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
11173450|NCT02015637|BG001|Baseline|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
11173451|NCT02015637|BG002|Baseline|Total|Total of all reporting groups
11173452|NCT02015637|FG000|Participant Flow|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
10913166|NCT00624338|BG002|Baseline|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913167|NCT00624338|BG003|Baseline|Total|Total of all reporting groups
10913168|NCT00624338|FG000|Participant Flow|Atacicept 75 mg|75 milligram (mg) atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913169|NCT00624338|FG001|Participant Flow|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913170|NCT00624338|FG002|Participant Flow|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913171|NCT00624338|OG000|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913172|NCT00624338|OG001|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913173|NCT00624338|OG002|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913174|NCT00624338|EG000|Reported Event|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913175|NCT00624338|EG001|Reported Event|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913176|NCT00624338|EG002|Reported Event|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
10913177|NCT00624377|BG000|Baseline|Spiriva 18µg With HandiHaler Device on COPD Patients|
10913178|NCT00624377|FG000|Participant Flow|Spiriva 18µg With HandiHaler Device on COPD Patients|
10913179|NCT00624377|OG000|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
10913180|NCT00624377|EG000|Reported Event|Spiriva 18µg With HandiHaler Device on COPD Patients|
10913181|NCT00624416|BG000|Baseline|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
10913182|NCT00624416|FG000|Participant Flow|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
10913183|NCT00624416|OG000|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
10913184|NCT00624416|EG000|Reported Event|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
10913185|NCT00624442|BG000|Baseline|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
10913186|NCT00624442|BG001|Baseline|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
10913187|NCT00624442|BG002|Baseline|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
10913188|NCT00624442|BG003|Baseline|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
10913189|NCT00624442|BG004|Baseline|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
10913190|NCT00624442|BG005|Baseline|Total|Total of all reporting groups
10913191|NCT00624442|FG000|Participant Flow|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
10913192|NCT00624442|FG001|Participant Flow|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
10913193|NCT00624442|FG002|Participant Flow|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
10913194|NCT00624442|FG003|Participant Flow|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
10913195|NCT00624442|FG004|Participant Flow|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
10913196|NCT00624442|OG000|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
10913197|NCT00624442|OG001|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
10913198|NCT00624442|OG002|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
10913199|NCT00624442|OG003|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
10913200|NCT00624442|OG004|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
10913201|NCT00624442|OG005|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
10913202|NCT00624442|OG000|Outcome|Cohort 1/2: 0.125 mg/kg/h + 0.0625 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.125 mg/kg/h IV for 1 hour (loading) + 0.0625 mg/kg/h IV for 1 hour (maintenance)
10913203|NCT00624442|OG001|Outcome|Cohort 1/2: 0.25 mg/kg/h + 0.125 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.25 mg/kg/h IV for 1 hour (loading) + 0.125 mg/kg/h IV for 1 hour (maintenance)
10913204|NCT00624442|OG002|Outcome|Cohort 1/2: 0.5 mg/kg/h + 0.25 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.5 mg/kg/h IV for 1 hour (loading) + 0.25 mg/kg/h IV for 1 hour (maintenance)
10913205|NCT00624442|OG003|Outcome|Cohort 1/2: 0.75 mg/kg/h + 0.375 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.75 mg/kg/h IV for 1 hour (loading) + 0.375 mg/kg/h IV for 1 hour (maintenance)
10913206|NCT00624442|OG004|Outcome|Cohort 1/2: 1.0 mg/kg/h + 0.5 mg/kg/h|Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour (loading) + 0.5 mg/kg/h IV for 1 hour (maintenance)
10913207|NCT00624442|OG005|Outcome|Cohort 3: 0.25 mg/kg/h + 0.025 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.25 mg/kg/h IV for 1 hour (loading) + 0.025 mg/kg/h IV for 23 hours (maintenance)
10913208|NCT00624442|OG006|Outcome|Cohort 3: 0.5 mg/kg/h + 0.05 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.50 mg/kg/h IV for 1 hour (loading) + 0.05 mg/kg/h IV for 23 hours (maintenance)
10913209|NCT00624442|OG007|Outcome|Cohort 3: 1.0 mg/kg/h + 0.1 mg/kg/h|Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour (loading) + 0.1 mg/kg/h IV for 23 hours (maintenance)
10913210|NCT00624442|OG008|Outcome|Cohort 4: 0.25 mg.kg.h + 0.125 mg/kg/h + 0.025 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.25 mg/kg/h IV for 1 hour + 0.125 mg/kg/h IV for 1 hour + 0.025 mg/kg/h IV for 22 hours
10913211|NCT00624442|OG009|Outcome|Cohort 4: 0.5 mg/kg/h + 0.25 mg/kg/h + 0.05 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.5 mg/kg/h IV for 1 hour + 0.25 mg/kg/h IV for 1 hour + 0.05 mg/kg/h IV for 22 hours
10913212|NCT00624442|OG010|Outcome|Cohort 4: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h|Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 22 hours
10913213|NCT00624442|OG011|Outcome|Cohort 5: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h|Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 70 hours
10913214|NCT00624442|OG012|Outcome|Cohort 5: 0.75 mg/kg/h + 0.375 mg/kg/h + 0.075 mg/kg/h|Subjects received the following CK-1827452 regimen: 0.75 mg/kg/h IV for 1 hour + 0.375 mg/kg/h IV for 1 hour + 0.075 mg/kg/h IV for 70 hours
10913215|NCT00624442|EG000|Reported Event|Placebo|
10913216|NCT00624442|EG001|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr|Loading dose is the first hour of IV infusion.
10913217|NCT00624442|EG002|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr|Loading dose is the first hour of IV infusion.
10913218|NCT00624442|EG003|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr|Loading dose is the first hour of IV infusion.
10913219|NCT00624442|EG004|Reported Event|Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
10913220|NCT00624442|EG005|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr|Loading dose is the first hour of IV infusion.
10913221|NCT00624442|EG006|Reported Event|Cohort 2, Loading Dose of 2.2 mg/kg/hr|Loading dose is first hour of IV infusion. This dose level occurred in 1 patient due to accidental overdose.
10913222|NCT00624442|EG007|Reported Event|Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr|Loading dose is first hour of IV infusion.
10913223|NCT00624442|EG008|Reported Event|Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr|Loading dose is first hour of IV infusion.
10913224|NCT00624442|EG009|Reported Event|Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
10913225|NCT00624442|EG010|Reported Event|Cohort 5, Loading Dose of 0.75 mg/kg/hr|Loading dose is first hour of IV infusion.
10913226|NCT00624442|EG011|Reported Event|Cohort 5, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
10913227|NCT00624468|BG000|Baseline|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
10913228|NCT00624468|BG001|Baseline|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
10913229|NCT00624468|BG002|Baseline|Total|Total of all reporting groups
10913230|NCT00624468|FG000|Participant Flow|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
10913231|NCT00624468|FG001|Participant Flow|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
10913232|NCT00624468|FG002|Participant Flow|Placebo: SFU Period|Subjects who received placebo matched to atacicept in double-blind period were included in safety follow-up (SFU) period (60 weeks) following premature termination of the trial.
10913233|NCT00624468|FG003|Participant Flow|Atacicept: SFU Period|Subjects who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
10913234|NCT00624468|OG000|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
10913235|NCT00624468|OG001|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
10913236|NCT00624468|EG000|Reported Event|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
10913237|NCT00624468|EG001|Reported Event|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
10913238|NCT00624468|EG002|Reported Event|Placebo: SFU Period|Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
10913239|NCT00624468|EG003|Reported Event|Atacicept: SFU Period|Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
10913240|NCT00624520|BG000|Baseline|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
10913241|NCT00624520|BG001|Baseline|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
10913242|NCT00624520|BG002|Baseline|Total|Total of all reporting groups
10913243|NCT00624520|FG000|Participant Flow|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
10913244|NCT00624520|FG001|Participant Flow|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
10913245|NCT00624520|OG000|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
10913246|NCT00624520|OG001|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
10913247|NCT00624520|EG000|Reported Event|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
10913248|NCT00624520|EG001|Reported Event|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
10913249|NCT00624559|BG000|Baseline|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
10913250|NCT00624559|BG001|Baseline|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
10913251|NCT00624559|BG002|Baseline|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
10913252|NCT00624559|BG003|Baseline|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
10913253|NCT00624559|BG004|Baseline|Total|Total of all reporting groups
10913254|NCT00624559|FG000|Participant Flow|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
10913255|NCT00624559|FG001|Participant Flow|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
10913256|NCT00624559|FG002|Participant Flow|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
10913257|NCT00624559|FG003|Participant Flow|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
10913258|NCT00624559|OG000|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
10913259|NCT00624559|OG001|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
10913260|NCT00624559|OG002|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
10913261|NCT00624559|OG003|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
10913262|NCT00624559|EG000|Reported Event|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
11233642|NCT02430090|FG001|Participant Flow|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
11233643|NCT02430090|FG002|Participant Flow|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
11233644|NCT02430090|OG000|Outcome|Levobupivacaine|2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I by intrathecal administration
11233645|NCT02430090|OG001|Outcome|Levobupivacaine + Fentanyl|2 ml of 0.5% levobupivacaine was added to 1 ml of 15 µcg of fentanyl in group II by intrathecal administration
11233646|NCT02430090|OG002|Outcome|Levobupivacaine + Sufentanil|2 ml of 0.5% levobupivacaine was added to 1 ml of 1,5 µcg sufentanil in group III by intrathecal administration
11233647|NCT02430090|EG000|Reported Event|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
11233648|NCT02430090|EG001|Reported Event|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
11233649|NCT02430090|EG002|Reported Event|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
11233650|NCT02430311|BG000|Baseline|Cohort 1|Olaparib 300 mg alone
11233651|NCT02430311|BG001|Baseline|Cohort 2|Olaparib 100 mg bd in combination with paclitaxel
11233652|NCT02430311|BG002|Baseline|Total|Total of all reporting groups
11233653|NCT02430311|FG000|Participant Flow|Cohort 1|Olaparib 300 mg alone
11233654|NCT02430311|FG001|Participant Flow|Cohort 2|Olaparib 100 mg bd in combination with paclitaxel
11233655|NCT02430311|OG000|Outcome|Cohort 1|Olaparib 300 mg alone
11233656|NCT02430311|OG001|Outcome|Cohort 2|Olaparib 100 mg bd in combination with paclitaxel
11233657|NCT02430311|OG000|Outcome|Cohort 2|Olaparib 100 mg bd in combination with paclitaxel
11233658|NCT02430311|OG001|Outcome|Cohort 1|Olaparib 300 mg alone
11233659|NCT02430311|OG001|Outcome|Cohort 2 (Olaparib Alone)|Cohort 2 patients with olaparib 100 mg alone dosed
11233660|NCT02430311|OG001|Outcome|Cohort 2, Olaparib Alone|Cohort 2 patients with olaparib 100 mg alone dosed
11233661|NCT02430311|OG000|Outcome|Cohort 2(Olaparib 100 mg + Paclitaxel)|Cohort 2 patients with Olaparib 100 mg dosed in combination with paclitaxel
11233662|NCT02430311|EG000|Reported Event|Cohort 1 Part A|Part A Olaparib 300 mg alone
10913263|NCT00624559|EG001|Reported Event|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
10913264|NCT00624559|EG002|Reported Event|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
10913265|NCT00624559|EG003|Reported Event|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
11233663|NCT02430311|EG001|Reported Event|Cohort 2 Part A, Olaparib 100 mg|Part A Cohort 2 patients, who have received olaparib 100 mg monotherapy treatment
11233664|NCT02430311|EG002|Reported Event|Cohort 2 Part A, Olaparib 100mg in Combination With Paclitaxel|Part A Cohort 2 patients, who have received olaparib 100 mg + paclitaxel treatment
11233665|NCT02430311|EG003|Reported Event|Cohort 1 Part B|Part B Olaparib 300 mg alone
10913266|NCT00624585|BG000|Baseline|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
10913267|NCT00624585|FG000|Participant Flow|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
10913268|NCT00624585|OG000|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
10913269|NCT00624585|EG000|Reported Event|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
10913270|NCT00624780|BG000|Baseline|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913271|NCT00624780|BG001|Baseline|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
11091700|NCT01535976|FG001|Participant Flow|Placebo|".9 normal saline infusion~Placebo : Placebo Comparator: Placebo~.9 normal saline infusion"
11091701|NCT01535976|OG000|Outcome|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min."
11173453|NCT02015637|FG001|Participant Flow|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
11173454|NCT02015637|OG000|Outcome|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
11173455|NCT02015637|OG001|Outcome|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
11091702|NCT01535976|OG001|Outcome|Placebo|"normal saline infusion~Placebo : Placebo Comparator: Placebo~normal saline infusion along with propofol 100 mcg/kg/min"
11091703|NCT01535976|EG000|Reported Event|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
11091704|NCT01535976|EG001|Reported Event|Placebo|".9 normal saline infusion~Placebo : Placebo Comparator: Placebo~.9 normal saline infusion"
11091705|NCT01536067|BG000|Baseline|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
11091706|NCT01536067|FG000|Participant Flow|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
10913272|NCT00624780|BG002|Baseline|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913273|NCT00624780|BG003|Baseline|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913274|NCT00624780|BG004|Baseline|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913275|NCT00624780|BG005|Baseline|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913276|NCT00624780|BG006|Baseline|Total|Total of all reporting groups
10913277|NCT00624780|FG000|Participant Flow|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913278|NCT00624780|FG001|Participant Flow|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913279|NCT00624780|FG002|Participant Flow|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913280|NCT00624780|FG003|Participant Flow|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913281|NCT00624780|FG004|Participant Flow|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913282|NCT00624780|FG005|Participant Flow|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913283|NCT00624780|OG000|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
10913284|NCT00624780|OG001|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
10913285|NCT00624780|OG002|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
10913286|NCT00624780|OG000|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913287|NCT00624780|OG001|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913288|NCT00624780|OG002|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913289|NCT00624780|OG003|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913290|NCT00624780|OG004|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913291|NCT00624780|OG005|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913292|NCT00624780|EG000|Reported Event|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913293|NCT00624780|EG001|Reported Event|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913294|NCT00624780|EG002|Reported Event|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
10913295|NCT00624780|EG003|Reported Event|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913296|NCT00624780|EG004|Reported Event|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
11091707|NCT01536067|OG000|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
11173456|NCT02015637|EG000|Reported Event|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
10913297|NCT00624780|EG005|Reported Event|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
10913298|NCT00624806|BG000|Baseline|Daily Group|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
10913299|NCT00624806|BG001|Baseline|Weekly Group|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
10913300|NCT00624806|BG002|Baseline|Total|Total of all reporting groups
10913301|NCT00624806|FG000|Participant Flow|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
10913302|NCT00624806|FG001|Participant Flow|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
10913303|NCT00624806|OG000|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
10913304|NCT00624806|OG001|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
10913305|NCT00624806|EG000|Reported Event|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.~No adverse events reported."
10913306|NCT00624806|EG001|Reported Event|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.~No adverse events reported."
10913307|NCT00624819|BG000|Baseline|Synflorix + Infanrix + Havrix and/or Varilrix Group|This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).
10913308|NCT00624819|BG001|Baseline|Prevenar + Infanrix + Havrix and/or Varilrix Group|This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).
10913309|NCT00624819|BG002|Baseline|Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix|This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).
10913310|NCT00624819|BG003|Baseline|Unprimed Group|"This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2).~The Unprimed Group was added only in Year 4 of the study."
10913311|NCT00624819|BG004|Baseline|Total|Total of all reporting groups
10913312|NCT00624819|FG000|Participant Flow|Synflorix + Infanrix + Havrix and/or Varilrix Group|This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).
11173457|NCT02015637|EG001|Reported Event|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
11233666|NCT02430311|EG004|Reported Event|Cohort 2 Part B, Olaparib 300 mg Monotherapy|Part B Cohort 2 patients, who continued on Olaparib 300mg monotherapy after completed combination therapy
11233667|NCT02430311|EG005|Reported Event|Cohort 2 Part B, Olaparib 100mg in Combination With Paclitaxel|Part B Cohort 2 patients, who have received olaparib 100 mg + paclitaxel treatment
10913313|NCT00624819|FG001|Participant Flow|Prevenar + Infanrix + Havrix and/or Varilrix Group|This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).
10913314|NCT00624819|FG002|Participant Flow|Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix|This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).
10913315|NCT00624819|FG003|Participant Flow|Unprimed Group|"This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2).~The Unprimed Group was added only in Year 4 of the study."
10913316|NCT00624819|OG000|Outcome|Synflorix + Infanrix + Havrix and/or Varilrix Group|This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).
10913317|NCT00624819|OG001|Outcome|Prevenar + Infanrix + Havrix and/or Varilrix Group|This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).
10913318|NCT00624819|OG002|Outcome|Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix|This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).
10913319|NCT00624819|OG003|Outcome|Unprimed Group|"This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2).~The Unprimed Group was added only in Year 4 of the study."
10913320|NCT00624819|EG000|Reported Event|Synflorix + Infanrix + Havrix and/or Varilrix Group|This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).
10913321|NCT00624819|EG001|Reported Event|Prevenar + Infanrix + Havrix and/or Varilrix Group|This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).
11233668|NCT02430337|BG000|Baseline|SafeCare-as-usual|"SafeCare as it is usually delivered~SafeCare: SafeCare, an evidence-based home visiting program"
11233669|NCT02430337|BG001|Baseline|Technology-Assisted SafeCare|"A modified version of SafeCare, using a tablet and online program to complete a portion of the session~Technology-Assisted SafeCare: A technology-enhanced version of SafeCare"
11233670|NCT02430337|BG002|Baseline|Total|Total of all reporting groups
10913322|NCT00624819|EG002|Reported Event|Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix|This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).
10913323|NCT00624819|EG003|Reported Event|Unprimed Group|"This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2).~The Unprimed Group was added only in Year 4 of the study."
10913324|NCT00624832|BG000|Baseline|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
10913325|NCT00624832|BG001|Baseline|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
10913326|NCT00624832|BG002|Baseline|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
10913327|NCT00624832|BG003|Baseline|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
10913328|NCT00624832|BG004|Baseline|Total|Total of all reporting groups
10913329|NCT00624832|FG000|Participant Flow|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
10913330|NCT00624832|FG001|Participant Flow|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
10913331|NCT00624832|FG002|Participant Flow|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
10913332|NCT00624832|FG003|Participant Flow|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
10913333|NCT00624832|OG000|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
10913334|NCT00624832|OG001|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
10913335|NCT00624832|OG002|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
10913336|NCT00624832|EG000|Reported Event|Xolair (IgE= 30- 300 IU/mL)|Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
10913337|NCT00624832|EG001|Reported Event|Xolair (IgE= 700- 2000 IU/mL)|Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
10913338|NCT00624832|EG002|Reported Event|Xolair (IgE= 301- 699 IU/mL)|Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
10913339|NCT00624832|EG003|Reported Event|Placebo Comparator|Placebo comparator
11342294|NCT03704376|BG001|Baseline|Adductor Canal Blockade|"Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).~15 ml of 0.2% ropivacaine~100 mcg clonidine~High-frequency linear ultrasound transducer"
10913340|NCT00624910|BG000|Baseline|Bupivacaine Sponges|"A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure~Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision."
10913341|NCT00624910|BG001|Baseline|Collagen Sponges|"A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure~placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision."
10913342|NCT00624910|BG002|Baseline|Standard of Care no Implant|The patient will receive the standard of care, but no implant during surgery
10913343|NCT00624910|BG003|Baseline|Total|Total of all reporting groups
10913344|NCT00624910|FG000|Participant Flow|Bupivacaine Sponges|"A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure~Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision."
10913345|NCT00624910|FG001|Participant Flow|Collagen Sponges|"A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure~placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision."
10913346|NCT00624910|FG002|Participant Flow|Standard of Care no Implant|The patient will receive the standard of care, but no implant during surgery
10913347|NCT00624910|OG000|Outcome|Bupivacaine Sponges|"A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure~Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision."
10913348|NCT00624910|OG001|Outcome|Collagen Sponges|"A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure~placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision."
10913349|NCT00624910|OG002|Outcome|Standard of Care no Implant|The patient will receive the standard of care, but no implant during surgery
10913350|NCT00624910|EG000|Reported Event|Bupivacaine Sponges|"A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure~Bupivacaine Collagen Sponge (CollaRx®): The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision."
10913351|NCT00624910|EG001|Reported Event|Collagen Sponges|"A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure~placebo: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision."
10913352|NCT00624910|EG002|Reported Event|Standard of Care no Implant|The patient will receive the standard of care, but no implant during surgery
10913353|NCT00624923|BG000|Baseline|1- Active Pharmacologic|"Salsalate~Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months"
10913354|NCT00624923|BG001|Baseline|2- Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
10913355|NCT00624923|BG002|Baseline|Total|Total of all reporting groups
10913356|NCT00624923|FG000|Participant Flow|1- Active Pharmacologic|"Salsalate~Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months"
10913357|NCT00624923|FG001|Participant Flow|2- Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
10913358|NCT00624923|OG000|Outcome|1- Active Pharmacologic|"Salsalate~Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months"
10913359|NCT00624923|OG001|Outcome|2-Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
10913360|NCT00624923|OG001|Outcome|2- Placebo|"Placebo~Placebo: Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months"
10913361|NCT00624923|OG001|Outcome|2- Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
10913362|NCT00624923|EG000|Reported Event|1- Active Pharmacologic|"Salsalate~Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months"
10913363|NCT00624923|EG001|Reported Event|2- Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
10913364|NCT00625131|BG000|Baseline|Arm 1|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
10913365|NCT00625131|BG001|Baseline|Arm 2|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
11342295|NCT03704376|BG002|Baseline|Total|Total of all reporting groups
10913366|NCT00625131|BG002|Baseline|Total|Total of all reporting groups
10913367|NCT00625131|FG000|Participant Flow|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
10913368|NCT00625131|FG001|Participant Flow|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
10913369|NCT00625131|FG002|Participant Flow|Not Randomized|This arm includes patients who met screening criteria for entry into the randomization, but withdrew prior to randomization.
10913370|NCT00625131|OG000|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
10913371|NCT00625131|OG001|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
10913372|NCT00625131|EG000|Reported Event|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
10913373|NCT00625131|EG001|Reported Event|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
10913374|NCT00625183|BG000|Baseline|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
10913375|NCT00625183|FG000|Participant Flow|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
10913376|NCT00625183|OG000|Outcome|Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
10913377|NCT00625183|OG000|Outcome|Capecitabine, Oxaliplatin, Selenomethionine,Radiation Therapy|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
10913378|NCT00625183|OG000|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
10913379|NCT00625183|EG000|Reported Event|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
10913380|NCT00625365|BG000|Baseline|DEFINITY (Perflutren Lipid Microsphere)|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
10913381|NCT00625365|FG000|Participant Flow|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
10913382|NCT00625365|OG000|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
10913383|NCT00625365|EG000|Reported Event|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
10913384|NCT00625391|BG000|Baseline|Placebo|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
10913385|NCT00625391|BG001|Baseline|Green Tea Polyphenols (GTP)|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
10913386|NCT00625391|BG002|Baseline|Placebo+Tai Chi|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
11091708|NCT01536067|EG000|Reported Event|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
11091709|NCT01536093|BG000|Baseline|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
11091710|NCT01536093|BG001|Baseline|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
11091711|NCT01536093|BG002|Baseline|Total|Total of all reporting groups
11091712|NCT01536093|FG000|Participant Flow|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
11091713|NCT01536093|FG001|Participant Flow|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
10913387|NCT00625391|BG003|Baseline|GTP+Tai Chi|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
10913388|NCT00625391|BG004|Baseline|Total|Total of all reporting groups
10913389|NCT00625391|FG000|Participant Flow|Placebo Group|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
10913390|NCT00625391|FG001|Participant Flow|Green Tea Polyphenols (GTP) Group|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
10913391|NCT00625391|FG002|Participant Flow|Placebo + Tai Chi Group|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
10913392|NCT00625391|FG003|Participant Flow|GTP + Tai Chi Group|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
10913393|NCT00625391|OG000|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.~Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.~placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.~GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
10913394|NCT00625391|OG001|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
10913395|NCT00625391|OG002|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
10913396|NCT00625391|OG003|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
10913397|NCT00625391|EG000|Reported Event|Placebo|Medicinal starch at 500 mg daily for 24 weeks
10913398|NCT00625391|EG001|Reported Event|Green Tea Polyphenols (GTP)|Green tea polyphenols at 500 mg daily for 24 weeks
10913399|NCT00625391|EG002|Reported Event|Placebo+Tai Chi (TC)|Medicinal starch at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
10913400|NCT00625391|EG003|Reported Event|GTP+TC|Green tea polyphenols at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
10913401|NCT00625404|BG000|Baseline|Truvada Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
10913402|NCT00625404|BG001|Baseline|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
10913403|NCT00625404|BG002|Baseline|Total|Total of all reporting groups
10913404|NCT00625404|FG000|Participant Flow|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
10913405|NCT00625404|FG001|Participant Flow|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
10913406|NCT00625404|OG000|Outcome|Truvada Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
10913407|NCT00625404|OG001|Outcome|Placebo Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
10913408|NCT00625404|OG000|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
11091714|NCT01536093|OG000|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
11091715|NCT01536093|OG001|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
11091716|NCT01536093|EG000|Reported Event|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
11091717|NCT01536093|EG001|Reported Event|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
11091718|NCT01536119|BG000|Baseline|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
11091719|NCT01536119|BG001|Baseline|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
11091720|NCT01536119|BG002|Baseline|Total|Total of all reporting groups
11091721|NCT01536119|FG000|Participant Flow|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
11091722|NCT01536119|FG001|Participant Flow|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
11091723|NCT01536119|OG000|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
11091724|NCT01536119|OG001|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
11091725|NCT01536119|EG000|Reported Event|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
11091726|NCT01536119|EG001|Reported Event|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
10913409|NCT00625404|OG001|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
10913410|NCT00625404|OG000|Outcome|Truvada Arm|The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.
10913411|NCT00625404|OG001|Outcome|Placebo Arm|The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.
10913412|NCT00625404|EG000|Reported Event|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
10913413|NCT00625404|EG001|Reported Event|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
10913414|NCT00625443|BG000|Baseline|Lower 1/3 Avatrombopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913415|NCT00625443|BG001|Baseline|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913416|NCT00625443|BG002|Baseline|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913417|NCT00625443|BG003|Baseline|Total|Total of all reporting groups
10913418|NCT00625443|FG000|Participant Flow|Lower 1/3 Avatromboopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913419|NCT00625443|FG001|Participant Flow|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913420|NCT00625443|FG002|Participant Flow|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913421|NCT00625443|OG000|Outcome|Lower 1/3 Avatrombopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913422|NCT00625443|OG001|Outcome|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913423|NCT00625443|OG002|Outcome|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913424|NCT00625443|OG000|Outcome|Responders|Participants continued on their previous blinded dose in study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
10913425|NCT00625443|OG001|Outcome|Nonresponders|Participants began treatment with open-label 10 mg avatrombopag daily. The maximum possible escalated dose was 40 mg/day open-label. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
11091727|NCT01536145|BG000|Baseline|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
10913426|NCT00625443|OG000|Outcome|Responders|Participants continued on their previous blinded dose study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
10913427|NCT00625443|EG000|Reported Event|Lower 1/3 Avatrombopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913428|NCT00625443|EG001|Reported Event|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
10913429|NCT00625443|EG002|Reported Event|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
11091728|NCT01536145|FG000|Participant Flow|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091729|NCT01536145|FG001|Participant Flow|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091730|NCT01536145|FG002|Participant Flow|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091731|NCT01536145|FG003|Participant Flow|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091732|NCT01536145|FG004|Participant Flow|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091733|NCT01536145|FG005|Participant Flow|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091734|NCT01536145|FG006|Participant Flow|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10913430|NCT00625729|BG000|Baseline|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
11342229|NCT03701061|EG000|Reported Event|Participants That Received AS03 Adjuvant|"Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).~Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study"
10913431|NCT00625729|FG000|Participant Flow|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
10913432|NCT00625729|OG000|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
10913433|NCT00625729|OG000|Outcome|Responder Patients|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy who had a response to treatment (clinical response or partial response).
10913434|NCT00625729|EG000|Reported Event|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
11091735|NCT01536145|FG007|Participant Flow|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
11091736|NCT01536145|FG008|Participant Flow|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091737|NCT01536145|FG009|Participant Flow|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
11091738|NCT01536145|FG010|Participant Flow|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
11091739|NCT01536145|OG000|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
11091740|NCT01536145|OG000|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091741|NCT01536145|OG001|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10913435|NCT00625807|BG000|Baseline|Relaxation Response|"One of the 2 stress reduction courses~Relaxation Response: A well-validated 8 week stress reduction course. Participants will be asked to perform stress reduction techniques from the Relaxation Response Program each night for 20 minutes throughout the entire 8-week course"
10913436|NCT00625807|BG001|Baseline|MBSR|"One of the 2 stress reduction courses~MBSR: A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques from the MBSR program each night for 20 minutes throughout the entire 8-week course"
10913437|NCT00625807|BG002|Baseline|Total|Total of all reporting groups
10913438|NCT00625807|FG000|Participant Flow|Relaxation Response (RR)|"One of the 2 stress reduction courses~A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation"
10913439|NCT00625807|FG001|Participant Flow|Mindfulness Based Stress Reduction (MBSR)|"One of the 2 stress reduction courses~A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness"
10913440|NCT00625807|OG000|Outcome|Relaxation Response (RR)|"One of the 2 stress reduction courses~A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation"
10913441|NCT00625807|OG001|Outcome|Mindfulness Based Stress Reduction (MBSR)|"One of the 2 stress reduction courses~A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness"
10913442|NCT00625807|OG000|Outcome|Relaxation Response|"One of the 2 stress reduction courses~A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing relaxation"
10913443|NCT00625807|OG001|Outcome|MBSR|"One of the 2 stress reduction courses~A well-validated 8 week stress reduction course. Participants were asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Meditation techniques focused on developing mindfulness"
10913444|NCT00625807|EG000|Reported Event|Relaxation Response|"One of the 2 stress reduction courses~Program A: A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course"
10913445|NCT00625807|EG001|Reported Event|MBSR|"One of the 2 stress reduction courses~Program B: A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course"
10913446|NCT00625820|BG000|Baseline|1BH4, BH4 + Vitamin C|"NA~Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
10913447|NCT00625820|FG000|Participant Flow|1BH4, BH4 + Vitamin C|"N/A~Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
10913448|NCT00625820|OG000|Outcome|1BH4, BH4 + Vitamin C|
10913449|NCT00625820|OG000|Outcome|1BH4, BH4 + Vitamin C|"NA~Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
10913450|NCT00625820|EG000|Reported Event|BH4, BH4 + Vit C|
10913451|NCT00625846|BG000|Baseline|Cohort 1 (DTC)|Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913452|NCT00625846|BG001|Baseline|Cohort 2 (MTC)|Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913453|NCT00625846|BG002|Baseline|Cohort 3 (ATC)|Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11342296|NCT03704376|FG000|Participant Flow|Femoral Nerve Blockade|"Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.~30 ml of 0.2% ropivacaine~100 mcg clonidine~High-frequency linear ultrasound transducer"
10913454|NCT00625846|BG003|Baseline|Expansion Cohort (DTC)|Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913455|NCT00625846|BG004|Baseline|Total|Total of all reporting groups
10913456|NCT00625846|FG000|Participant Flow|Cohort 1 (DTC)|Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913457|NCT00625846|FG001|Participant Flow|Cohort 2 (MTC)|Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913458|NCT00625846|FG002|Participant Flow|Cohort 3 (ATC)|Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913459|NCT00625846|FG003|Participant Flow|Expansion Cohort (DTC)|Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913460|NCT00625846|OG000|Outcome|Cohort 1 (DTC)|"Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.> > Laboratory Biomarker Analysis: Correlative studies>~> Pazopanib Hydrochloride: Given PO"
10913461|NCT00625846|OG001|Outcome|Cohort 2 (MTC)|"Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.>~> Pazopanib Hydrochloride: Given PO"
10913462|NCT00625846|OG002|Outcome|Cohort 3 (ATC)|"Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.>~> Laboratory Biomarker Analysis: Correlative studies"
10913463|NCT00625846|OG003|Outcome|Expansion Cohort (DTC)|"Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.> > Laboratory Biomarker Analysis: Correlative studies>~> Pazopanib Hydrochloride: Given PO"
10913464|NCT00625846|OG000|Outcome|Cohort 1 (DTC)|Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913465|NCT00625846|OG001|Outcome|Cohort 2 (MTC)|Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913466|NCT00625846|OG002|Outcome|Cohort 3 (ATC)|Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913467|NCT00625846|OG003|Outcome|Expansion Cohort (DTC)|Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913468|NCT00625846|EG000|Reported Event|Cohort 1 (DTC)|Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913469|NCT00625846|EG001|Reported Event|Cohort 2 (MTC)|Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913470|NCT00625846|EG002|Reported Event|Cohort 3 (ATC)|Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913471|NCT00625846|EG003|Reported Event|Expansion Cohort (DTC)|Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10913472|NCT00625872|BG000|Baseline|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
10913473|NCT00625872|BG001|Baseline|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
10913474|NCT00625872|BG002|Baseline|Total|Total of all reporting groups
10913475|NCT00625872|FG000|Participant Flow|Somatropin|Somatropin 0.035 milligram/kilogram/day (mg/kg/day) was administered subcutaneously (s.c) according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
10913476|NCT00625872|FG001|Participant Flow|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
10913477|NCT00625872|OG000|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
10913478|NCT00625872|OG001|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
10913479|NCT00625872|EG000|Reported Event|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
10913480|NCT00625872|EG001|Reported Event|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
10913481|NCT00625989|BG000|Baseline|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
10913482|NCT00625989|FG000|Participant Flow|Diluent Then Allergen Challenge|"Subjects were screened, then given a 2 week washout period.~Samples collected on day 1 according to protocol. Day 2 diluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.~Two week wash out period.~Samples collected on day 1, after washout, according to protocol. Day 2, after washout, allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
10913483|NCT00625989|FG001|Participant Flow|Allergen Then Diluent Challenge|"Subjects were screened, then given a 2 week washout period.~Samples collected on day 1 according to protocol. Day 2 allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.~Two week wash out period.~Samples collected on day 1, after washout, according to protocol. Day 2, after washout, dilluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
10913484|NCT00625989|OG000|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
10913485|NCT00625989|OG001|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
10913486|NCT00625989|EG000|Reported Event|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
10913487|NCT00626028|BG000|Baseline|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.
10913488|NCT00626028|BG001|Baseline|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
10913489|NCT00626028|BG002|Baseline|Total|Total of all reporting groups
10913490|NCT00626028|FG000|Participant Flow|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.
10913491|NCT00626028|FG001|Participant Flow|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
10913492|NCT00626028|OG000|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.
11173458|NCT02015676|BG000|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, from Week 1. If no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
11173459|NCT02015676|BG001|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
11335641|NCT03554018|EG001|Reported Event|Placebo|"Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.~Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)~Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours"
10913493|NCT00626028|OG001|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
10913494|NCT00626028|EG000|Reported Event|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.
10913495|NCT00626028|EG001|Reported Event|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
10915151|NCT00634179|BG000|Baseline|Treatment (VR-CHOP Regimen)|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.~MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity."
10915152|NCT00634179|FG000|Participant Flow|Treatment (VR-CHOP Regimen)|"Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy regimen.~In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-cell non-Hodgkin's lymphoma (B-NHL)(Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma."
10915153|NCT00634179|OG000|Outcome|MTD of Bortezomib With Vincristine Capped at 1.5 mg|Maximal tolerated dose (MTD) of bortezomib when vincristine is capped at 1.5 mg
10915154|NCT00634179|OG000|Outcome|Phase I: Induction|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
10915155|NCT00634179|OG001|Outcome|Phase II: Maintenance|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.~MAINTENANCE: Patients achieving CR receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or PR receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.~Bortezomib: Bortezomib 1.6 mg/m² given on days 1 and 8~Rituximab: Rituximab 375 mg/m²~Doxorubicin: Doxorubicin 50 mg/m²~Cyclophosphamide: Cyclophosphamide 750 mg/m²~Vincristine: Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1~Prednisone: Prednisone 100 mg/day given orally on"
10915156|NCT00634179|EG000|Reported Event|Phase I: Induction|Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the CHOP chemotherapy regimen.
10915157|NCT00634179|EG001|Reported Event|Phase II: Maintenance|In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-NHL. (Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma.
10913496|NCT00626093|BG000|Baseline|Group 1|
10913497|NCT00626093|FG000|Participant Flow|Cardiac Resynchronization Therapy - Defibrillators (CRT-D)|All patients enrolled were indicated for a CRT-D.
10913498|NCT00626093|OG000|Outcome|CRT-D|
10913499|NCT00626093|EG000|Reported Event|Group 1|
10913500|NCT00626197|BG000|Baseline|OCR 400 mg + SOC|Participants received 400 mg ocrelizumab IV on Days 1 and 15, followed by 400 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913501|NCT00626197|BG001|Baseline|OCR 1000 mg + SOC|Participants received 1000 mg ocrelizumab IV on Days 1 and 15, followed by 1000 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913502|NCT00626197|BG002|Baseline|Placebo + SOC|Participants received placebo matched to ocrelizumab infusion intravenously (IV) on Days 1 and 15, followed by placebo matched to ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or mycophenolate mofetil (MMF) 1 grams per day (g/day) in the first week increased to 3 g/day. Participants also received methylprednisolone 100 milligram (mg) infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of placebo. Participants also received oral prednisone at a starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913503|NCT00626197|BG003|Baseline|Total|Total of all reporting groups
10913504|NCT00626197|FG000|Participant Flow|OCR 400 mg + SOC|Participants received 400 mg ocrelizumab IV on Days 1 and 15, followed by 400 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913505|NCT00626197|FG001|Participant Flow|OCR 1000 mg + SOC|Participants received 1000 mg ocrelizumab IV on Days 1 and 15, followed by 1000 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913506|NCT00626197|FG002|Participant Flow|Placebo + SOC|Participants received placebo matched to ocrelizumab infusion intravenously (IV) on Days 1 and 15, followed by placebo matched to ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or mycophenolate mofetil (MMF) 1 grams per day (g/day) in the first week increased to 3 g/day. Participants also received methylprednisolone 100 milligram (mg) infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of placebo. Participants also received oral prednisone at a starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
11335642|NCT03554486|BG000|Baseline|Fiasp Then Novolog|Following a 2-week run-in period, participants use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks.
10913507|NCT00626197|OG000|Outcome|OCR 400 mg + SOC|Participants received 400 mg ocrelizumab IV on Days 1 and 15, followed by 400 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
11335643|NCT03554486|BG001|Baseline|Novolog Then Fiasp|Following a 2-week run-in period, participants use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks.
11335644|NCT03554486|BG002|Baseline|Total|Total of all reporting groups
10913508|NCT00626197|OG001|Outcome|OCR 1000 mg + SOC|Participants received 1000 mg ocrelizumab IV on Days 1 and 15, followed by 1000 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913509|NCT00626197|OG002|Outcome|Placebo + SOC|Participants received placebo matched to ocrelizumab infusion intravenously (IV) on Days 1 and 15, followed by placebo matched to ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or mycophenolate mofetil (MMF) 1 grams per day (g/day) in the first week increased to 3 g/day. Participants also received methylprednisolone 100 milligram (mg) infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of placebo. Participants also received oral prednisone at a starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913510|NCT00626197|OG000|Outcome|Placebo + SOC|Participants received placebo matched to ocrelizumab infusion intravenously (IV) on Days 1 and 15, followed by placebo matched to ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or mycophenolate mofetil (MMF) 1 grams per day (g/day) in the first week increased to 3 g/day. Participants also received methylprednisolone 100 milligram (mg) infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of placebo. Participants also received oral prednisone at a starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913511|NCT00626197|OG001|Outcome|OCR 400 mg + SOC|Participants received 400 mg ocrelizumab IV on Days 1 and 15, followed by 400 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913512|NCT00626197|OG002|Outcome|OCR 1000 mg + SOC|Participants received 1000 mg ocrelizumab IV on Days 1 and 15, followed by 1000 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913513|NCT00626197|OG003|Outcome|OCR + SOC|This analysis set included all participants who were treated with ocrelizumab (OCR).
10913514|NCT00626197|OG004|Outcome|Placebo-Mycophenolate Mofetil (MMF)|Placebo - MMF group included participants whose SOC treatment included MMF as an immunosuppressant treatment.
10913515|NCT00626197|OG005|Outcome|Placebo-Euro Lupus (EL)|Placebo-EL group included participants whose SOC treatment included Cyclophosphamide (Euro-lupus) as part of the immunosuppressant treatment.
10913516|NCT00626197|EG000|Reported Event|Placebo + SOC|Participants received placebo matched to ocrelizumab infusion intravenously (IV) on Days 1 and 15, followed by placebo matched to ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or mycophenolate mofetil (MMF) 1 grams per day (g/day) in the first week increased to 3 g/day. Participants also received methylprednisolone 100 milligram (mg) infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of placebo. Participants also received oral prednisone at a starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913517|NCT00626197|EG001|Reported Event|OCR 1000 mg + SOC|Participants received 1000 mg ocrelizumab IV on Days 1 and 15, followed by 1000 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10915158|NCT00634244|BG000|Baseline|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
10913518|NCT00626197|EG002|Reported Event|OCR 400 mg + SOC|Participants received 400 mg ocrelizumab IV on Days 1 and 15, followed by 400 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day [mg/kg/day]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day.
10913519|NCT00626210|BG000|Baseline|Modafinil|Open label study in which all participants get modafinil
10913520|NCT00626210|FG000|Participant Flow|Modafinil|daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week
10913521|NCT00626210|OG000|Outcome|Modafinil|
10913522|NCT00626210|EG000|Reported Event|Modafinil|
10913523|NCT00626275|BG000|Baseline|All Treated Participants|All participants who received at least 1 dose of study drug during any sequence of Part A of the study. Baseline measures reported in aggregate for all participants to avoid double counting of Parts A and B.
10913524|NCT00626275|FG000|Participant Flow|Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then ADL5859 200 milligrams (mg), then naproxen 500 mg).~Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose"
10913525|NCT00626275|FG001|Participant Flow|Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then naproxen 500 mg, then placebo).~Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
10913526|NCT00626275|FG002|Participant Flow|Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then placebo, then ADL5859 200 mg).~Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
10913527|NCT00626275|FG003|Participant Flow|Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then ADL5859 200 mg, then placebo).~Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
11091742|NCT01536145|OG002|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10913528|NCT00626275|FG004|Participant Flow|Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then naproxen 500 mg, then ADL5859 200 mg).~Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
10913529|NCT00626275|FG005|Participant Flow|Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then placebo, then naproxen 500 mg).~Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose."
10913530|NCT00626275|FG006|Participant Flow|Part B: ADL5859 100 mg|ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study
10913531|NCT00626275|FG007|Participant Flow|Part B: Placebo|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
10913532|NCT00626275|OG000|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
10913533|NCT00626275|OG001|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
10913534|NCT00626275|OG002|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
11091743|NCT01536145|OG003|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10913535|NCT00626275|OG000|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
10913536|NCT00626275|OG001|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
10913537|NCT00626275|OG000|Outcome|Placebo (Part A)|Matching placebo capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
10913538|NCT00626275|OG002|Outcome|ADL5859 - 200mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
10913539|NCT00626275|EG000|Reported Event|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
10913540|NCT00626275|EG001|Reported Event|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
10913541|NCT00626275|EG002|Reported Event|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
10913542|NCT00626275|EG003|Reported Event|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
10913543|NCT00626275|EG004|Reported Event|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
10913544|NCT00626327|BG000|Baseline|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
11174302|NCT02020785|BG001|Baseline|Lower Phosphorus Period Then Higher Phosphorus Period|"Randomized to higher phosphorus period first, then lower phosphorus period second.~Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks~At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives~Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks~Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) given for 3 weeks"
10913545|NCT00626327|BG001|Baseline|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
10913546|NCT00626327|BG002|Baseline|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
10913547|NCT00626327|BG003|Baseline|Total|Total of all reporting groups
10913548|NCT00626327|FG000|Participant Flow|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
10913549|NCT00626327|FG001|Participant Flow|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
10913550|NCT00626327|FG002|Participant Flow|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
10913551|NCT00626327|OG000|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
10913552|NCT00626327|OG001|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
10913553|NCT00626327|OG001|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
10913554|NCT00626327|OG000|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
10913555|NCT00626327|OG000|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
10913556|NCT00626327|OG001|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
10913557|NCT00626327|OG000|Outcome|MenACWY-CRM + MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
10913558|NCT00626327|OG000|Outcome|MenACWY-CRM +MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
10913559|NCT00626327|OG000|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
10913560|NCT00626327|OG002|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
10913561|NCT00626327|OG002|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
10913562|NCT00626327|EG000|Reported Event|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
10913563|NCT00626327|EG001|Reported Event|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
10913564|NCT00626327|EG002|Reported Event|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
10913565|NCT00626340|BG000|Baseline|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
10913566|NCT00626340|FG000|Participant Flow|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
10913567|NCT00626340|OG000|Outcome|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
10913568|NCT00626340|EG000|Reported Event|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
10913569|NCT00626366|BG000|Baseline|Nasal Spray|"This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.~Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses~Omnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml."
10913570|NCT00626366|BG001|Baseline|Nasal Drops|"This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.~Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses~Omnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml."
10913571|NCT00626366|BG002|Baseline|Total|Total of all reporting groups
10913572|NCT00626366|FG000|Participant Flow|Nasal Spray|"This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.~Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses~Omnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml."
11091744|NCT01536145|OG004|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091745|NCT01536145|OG005|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091746|NCT01536145|OG006|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10913573|NCT00626366|FG001|Participant Flow|Nasal Drops|"This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.~Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses~Omnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml."
10913574|NCT00626366|OG000|Outcome|Nasal Spray|"This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.~Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses~Omnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml."
10913575|NCT00626366|OG001|Outcome|Nasal Drops|"This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.~Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses~Omnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml."
10913576|NCT00626366|EG000|Reported Event|Nasal Spray|"This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.~Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses~Omnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml."
10913577|NCT00626366|EG001|Reported Event|Nasal Drop|"This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.~Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses~Omnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml."
10913578|NCT00626392|BG000|Baseline|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
11091747|NCT01536145|OG007|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
11091748|NCT01536145|OG008|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091749|NCT01536145|OG009|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
11091750|NCT01536145|OG010|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
11174303|NCT02020785|BG002|Baseline|Total|Total of all reporting groups
10913579|NCT00626392|BG001|Baseline|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
10913580|NCT00626392|BG002|Baseline|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
10913581|NCT00626392|BG003|Baseline|NER 1000; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
11173460|NCT02015676|BG002|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II and II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
11173461|NCT02015676|BG003|Baseline|Total|Total of all reporting groups
11173462|NCT02015676|FG000|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
11173463|NCT02015676|FG001|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
11173464|NCT02015676|FG002|Participant Flow|Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
10913582|NCT00626392|BG004|Baseline|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
10913583|NCT00626392|BG005|Baseline|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
10913584|NCT00626392|BG006|Baseline|Total|Total of all reporting groups
10913585|NCT00626392|FG000|Participant Flow|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
10913586|NCT00626392|FG001|Participant Flow|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
11173465|NCT02015676|OG000|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
11173466|NCT02015676|EG000|Reported Event|Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
11335645|NCT03554486|FG000|Participant Flow|All Participants (run-in Period)|Participants entered a 2-week run-in period prior to randomization.
10913587|NCT00626392|FG002|Participant Flow|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
10913588|NCT00626392|FG003|Participant Flow|NER 1000; ASA run-in; ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
10913589|NCT00626392|FG004|Participant Flow|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
10913590|NCT00626392|FG005|Participant Flow|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
10913591|NCT00626392|OG000|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
10913592|NCT00626392|OG001|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
10913593|NCT00626392|EG000|Reported Event|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
10913594|NCT00626392|EG001|Reported Event|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
10913595|NCT00626405|BG000|Baseline|Arm I|"Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.> > bevacizumab: Given IV over 30-90 minutes>~> temozolomide: Oral temozolomide on days 1-5"
10913596|NCT00626405|BG001|Baseline|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.>~> bevacizumab: Given IV over 30-90 minutes>~> carboplatin: Given IV over 30 minutes>~> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes"
10913597|NCT00626405|BG002|Baseline|Total|Total of all reporting groups
10913598|NCT00626405|FG000|Participant Flow|Arm I|"Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.> > bevacizumab: Given IV over 30-90 minutes>~> temozolomide: Oral temozolomide on days 1-5"
10913599|NCT00626405|FG001|Participant Flow|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.>~> bevacizumab: Given IV over 30-90 minutes>~> carboplatin: Given IV over 30 minutes>~> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes"
10913600|NCT00626405|OG000|Outcome|Arm I|"Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.~>~> bevacizumab: Given IV over 30-90 minutes~>~> temozolomide: Oral temozolomide on days 1-5"
10913601|NCT00626405|OG001|Outcome|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.~>~> bevacizumab: Given IV over 30-90 minutes~>~> carboplatin: Given IV over 30 minutes~>~> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes"
10913602|NCT00626405|EG000|Reported Event|Arm I|temozolomide: Oral temozolomide on days 1-5
10913603|NCT00626405|EG001|Reported Event|Arm II|paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
10913604|NCT00626431|BG000|Baseline|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
10913605|NCT00626431|BG001|Baseline|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
10913606|NCT00626431|BG002|Baseline|Total|Total of all reporting groups
10913607|NCT00626431|FG000|Participant Flow|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
10913608|NCT00626431|FG001|Participant Flow|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
10913609|NCT00626431|OG000|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
10913610|NCT00626431|OG000|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
10913611|NCT00626431|EG000|Reported Event|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
10913612|NCT00626431|EG001|Reported Event|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
10913613|NCT00626522|BG000|Baseline|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
10913614|NCT00626522|BG001|Baseline|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
10913615|NCT00626522|BG002|Baseline|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
10913616|NCT00626522|BG003|Baseline|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
10913617|NCT00626522|BG004|Baseline|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
10913618|NCT00626522|BG005|Baseline|Placebo|Placebo once-daily
10913619|NCT00626522|BG006|Baseline|Total|Total of all reporting groups
10913620|NCT00626522|FG000|Participant Flow|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
10913621|NCT00626522|FG001|Participant Flow|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
10913622|NCT00626522|FG002|Participant Flow|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
10913623|NCT00626522|FG003|Participant Flow|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
10913624|NCT00626522|FG004|Participant Flow|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
10913625|NCT00626522|FG005|Participant Flow|Placebo|Placebo once-daily
10913626|NCT00626522|OG000|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
10913627|NCT00626522|OG001|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
10913628|NCT00626522|OG002|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
10913629|NCT00626522|OG003|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
10913630|NCT00626522|OG004|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
10913631|NCT00626522|OG005|Outcome|Placebo|Placebo once-daily
10913632|NCT00626522|EG000|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
10913633|NCT00626522|EG001|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
10913634|NCT00626522|EG002|Reported Event|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
10913635|NCT00626522|EG003|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
10913636|NCT00626522|EG004|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
10913637|NCT00626522|EG005|Reported Event|Placebo|Placebo once-daily
10913638|NCT00626548|BG000|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
10913639|NCT00626548|BG001|Baseline|Placebo|Placebo oral tablet once daily
10913640|NCT00626548|BG002|Baseline|Total|Total of all reporting groups
10913641|NCT00626548|FG000|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
10913642|NCT00626548|FG001|Participant Flow|Placebo|Placebo oral tablet once daily
10913643|NCT00626548|OG000|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
10913644|NCT00626548|OG001|Outcome|Placebo|Placebo oral tablet once daily
10913645|NCT00626548|EG000|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
10913646|NCT00626548|EG001|Reported Event|Placebo|Placebo oral tablet once daily
10913647|NCT00626574|BG000|Baseline|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
10913648|NCT00626574|BG001|Baseline|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
10913649|NCT00626574|BG002|Baseline|Total|Total of all reporting groups
10913650|NCT00626574|FG000|Participant Flow|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
10913651|NCT00626574|FG001|Participant Flow|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
10913652|NCT00626574|OG000|Outcome|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
10913653|NCT00626574|OG001|Outcome|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
10913654|NCT00626574|OG000|Outcome|Group A|"Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.~Epoetin alfa: Intravenous administration of epoetin alfa (40,000 IU) immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose."
10913655|NCT00626574|OG001|Outcome|Group B|"Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).~Saline: 3ml of saline will be administered via an IV push immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose."
10913656|NCT00626574|EG000|Reported Event|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
10913657|NCT00626574|EG001|Reported Event|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
10913658|NCT00626626|BG000|Baseline|Dose Level1|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
10915159|NCT00634244|BG001|Baseline|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
10915160|NCT00634244|BG002|Baseline|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
10913659|NCT00626626|BG001|Baseline|Dose Level 2|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
10913660|NCT00626626|BG002|Baseline|Total|Total of all reporting groups
10913661|NCT00626626|FG000|Participant Flow|"Clofar, Cyclophos, Alemtuzumab"|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
10913662|NCT00626626|FG001|Participant Flow|"Clofar, Cyclophos,Alemtuzumab(Ph II)"|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
10913663|NCT00626626|OG000|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I )|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
10913664|NCT00626626|OG001|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
10913665|NCT00626626|OG000|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
10913666|NCT00626626|EG000|Reported Event|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
10913667|NCT00626626|EG001|Reported Event|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
10913668|NCT00626639|BG000|Baseline|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
10913669|NCT00626639|BG001|Baseline|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
10913670|NCT00626639|BG002|Baseline|Total|Total of all reporting groups
11335646|NCT03554486|FG001|Participant Flow|Fiasp Then Novolog|Following randomization after a 2-week run-in period, participants use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks.
10915161|NCT00634244|BG003|Baseline|Total|Total of all reporting groups
11335647|NCT03554486|FG002|Participant Flow|Novolog Then Fiasp|Following randomization after a 2-week run-in period, participants use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks.
10913671|NCT00626639|FG000|Participant Flow|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
10913672|NCT00626639|FG001|Participant Flow|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
10913673|NCT00626639|OG000|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
10913674|NCT00626639|OG001|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
10913675|NCT00626639|OG000|Outcome|Placebo|Subjects who received placebo during the acute phase of the study.
10913676|NCT00626639|OG001|Outcome|Palifermin|Subjects who received Palifermin during the acute phase of the study.
10913677|NCT00626639|EG000|Reported Event|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
10913678|NCT00626639|EG001|Reported Event|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
10913679|NCT00626743|BG000|Baseline|INJE University Pusan Paik Hospital|
10913680|NCT00626743|BG001|Baseline|Asan Medical Center|
10913681|NCT00626743|BG002|Baseline|Total|Total of all reporting groups
10913682|NCT00626743|FG000|Participant Flow|SK3530|"Active Drug~SK3530 100mg, Placebo, Amlodipine"
10913683|NCT00626743|FG001|Participant Flow|Placebo|"Tablet which has the same appearance and taste but doesn't contain active ingredient~SK3530 100mg, Placebo, Amlodipine"
10913684|NCT00626743|OG000|Outcome|Amlodipine + SK3530|
10913685|NCT00626743|OG001|Outcome|Amlodipine + Placebo|
10913686|NCT00626743|EG000|Reported Event|Amlodipine + SK3530|
10913687|NCT00626743|EG001|Reported Event|Amlodipine + Placebo|
10913688|NCT00626782|BG000|Baseline|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
10913689|NCT00626782|BG001|Baseline|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
11335648|NCT03554486|OG000|Outcome|Fiasp Insulin|Participants use Fiasp insulin for 2 weeks.
10913690|NCT00626782|BG002|Baseline|Total|Total of all reporting groups
10913691|NCT00626782|FG000|Participant Flow|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
10913692|NCT00626782|FG001|Participant Flow|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
10913693|NCT00626782|OG000|Outcome|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
10913694|NCT00626782|OG001|Outcome|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
10913695|NCT00626782|OG000|Outcome|A: Ranibizumab 0.5mg (0.05mL) Injection|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
10913696|NCT00626782|OG001|Outcome|B: Mitomycin C 0.4 mg/ml Sponge|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.~Mitomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
10913697|NCT00626782|EG000|Reported Event|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
11335649|NCT03554486|OG001|Outcome|Novolog Insulin|Participants use Novolog insulin for 2 weeks.
10913698|NCT00626782|EG001|Reported Event|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
10913699|NCT00626795|BG000|Baseline|TD1414 BID|TD1414 2% cream: two times daily (BID) 7 days
10913700|NCT00626795|BG001|Baseline|TD1414 TID|TD1414 2% cream: three times daily (TID) 7 days
10913701|NCT00626795|BG002|Baseline|Bactroban® TID|Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days
10913702|NCT00626795|BG003|Baseline|Total|Total of all reporting groups
10913703|NCT00626795|FG000|Participant Flow|TD1414 BID|TD1414 2% cream: two times daily (BID) 7 days
10913704|NCT00626795|FG001|Participant Flow|TD1414 TID|TD1414 2% cream: three times daily (TID) 7 days
10913705|NCT00626795|FG002|Participant Flow|Bactroban® TID|Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days
10913706|NCT00626795|OG000|Outcome|TD1414 BID|TD1414 2% cream: two times daily (BID) for 7 days
10913707|NCT00626795|OG001|Outcome|TD1414 TID|TD1414 2% cream: three times daily (TID) for 7 days
10913708|NCT00626795|OG002|Outcome|Bactroban® TID|Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
10913709|NCT00626795|EG000|Reported Event|TD1414 TID >=16 Years|Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
10913710|NCT00626795|EG001|Reported Event|TD1414 TID >=12 to <16 Years|Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
10913711|NCT00626795|EG002|Reported Event|TD1414 TID >=6 to <12 Years|Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
10913712|NCT00626795|EG003|Reported Event|TD1414 TID >=2 to <6 Years|Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
10913713|NCT00626795|EG004|Reported Event|TD1414 BID|Blinded treatment TD1414 2% cream: two times daily (BID) for 7 days
10913714|NCT00626795|EG005|Reported Event|TD1414 TID|Blinded treatment TD1414 2% cream: three times daily (TID) for 7 days
10913715|NCT00626795|EG006|Reported Event|Bactroban® TID|Blinded treatment Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
10913716|NCT00626808|BG000|Baseline|Participants Less Than 24 Months of Age|Participants less than 24 months of age
10913717|NCT00626808|BG001|Baseline|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
10913718|NCT00626808|BG002|Baseline|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
10913719|NCT00626808|BG003|Baseline|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
10913720|NCT00626808|BG004|Baseline|Total|Total of all reporting groups
10913721|NCT00626808|FG000|Participant Flow|Participants Less Than 24 Months of Age|Participants less than 24 months of age
10913722|NCT00626808|FG001|Participant Flow|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
10913723|NCT00626808|FG002|Participant Flow|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
10913724|NCT00626808|FG003|Participant Flow|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
10913725|NCT00626808|OG000|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
10913726|NCT00626808|OG001|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
10913727|NCT00626808|OG002|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
10913728|NCT00626808|OG003|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
10913729|NCT00626808|EG000|Reported Event|Participants Less Than 24 Months of Age|Participants less than 24 months of age
10913730|NCT00626808|EG001|Reported Event|Children 24-59 Months With Asthma|
10913731|NCT00626808|EG002|Reported Event|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
10913732|NCT00626808|EG003|Reported Event|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
10913733|NCT00626821|BG000|Baseline|SenSura|Test of SenSura for 6-8 weeks
10913734|NCT00626821|FG000|Participant Flow|SenSura|Test of SenSura for 6-8 weeks
10913735|NCT00626821|OG000|Outcome|SenSura|Participants tested SenSura for 6-8 weeks. Baseline data were informations about pre-study product.
10913736|NCT00626821|EG000|Reported Event|SenSura|Test of SenSura for 6-8 weeks
10913737|NCT00626886|BG000|Baseline|Bupivacaine Collagen Sponge|"Two, 5x5cm bupivacaine collagen sponges implanted during surgery~Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride"
10913738|NCT00626886|BG001|Baseline|Placebo Collagen Sponge|"Placebo collagen sponge implanted during surgery~placebo collagen sponge: collagen"
10913739|NCT00626886|BG002|Baseline|Total|Total of all reporting groups
10913740|NCT00626886|FG000|Participant Flow|Bupivacaine Collagen Sponge|"Two, 5x5cm bupivacaine collagen sponges implanted during surgery~Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride"
10913741|NCT00626886|FG001|Participant Flow|Placebo Collagen Sponge|"Placebo collagen sponge implanted during surgery~placebo collagen sponge: collagen"
10913742|NCT00626886|OG000|Outcome|Bupivacaine Collagen Sponge|"Two, 5x5cm bupivacaine collagen sponges implanted during surgery~Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride"
10913743|NCT00626886|OG001|Outcome|Placebo Collagen Sponge|"Placebo collagen sponge implanted during surgery~placebo collagen sponge: collagen"
10913744|NCT00626886|EG000|Reported Event|Bupivacaine Collagen Sponge|"Two, 5x5cm bupivacaine collagen sponges implanted during surgery~Bupivacaine Collagen Sponge: collagen; Bupivacaine hydrocholoride"
10913745|NCT00626886|EG001|Reported Event|Placebo Collagen Sponge|"Placebo collagen sponge implanted during surgery~placebo collagen sponge: collagen"
10913746|NCT00626912|BG000|Baseline|Platinum Coils|"Endovascular coil embolization with standard platinum coils~endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques"
10913747|NCT00626912|BG001|Baseline|Hydrogel Coils|"Endovascular coil embolization with hydrogel coils~endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques"
10913748|NCT00626912|BG002|Baseline|Total|Total of all reporting groups
10913749|NCT00626912|FG000|Participant Flow|Platinum Coils|Endovascular coil embolization with standard platinum coils
10913750|NCT00626912|FG001|Participant Flow|Hydrogel Coils|Endovascular Coil embolization with Hydrogel Coils
10913751|NCT00626912|OG000|Outcome|Platinum Coils|"platinum coils~endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques"
10913752|NCT00626912|OG001|Outcome|Hydrogel Coils|"hydrogel coils~endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques"
10913753|NCT00626912|EG000|Reported Event|Platinum Coils|"platinum coils~endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques"
10913754|NCT00626912|EG001|Reported Event|Hydrogel Coils|"hydrogel coils~endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques"
10913755|NCT00626925|BG000|Baseline|Total Topiramate Group|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913756|NCT00626925|BG001|Baseline|Total Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913757|NCT00626925|BG002|Baseline|Total|Total of all reporting groups
11335650|NCT03554486|EG000|Reported Event|Run-in Period|Participants with events occurring prior to randomization.
10913758|NCT00626925|FG000|Participant Flow|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913759|NCT00626925|FG001|Participant Flow|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913760|NCT00626925|OG000|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913761|NCT00626925|OG001|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913762|NCT00626925|OG000|Outcome|Total Topiramate Group|"Topiramate capsules beginning at 25 mg/day with gradual increase to a maximum of 200 mg orally)~Topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913763|NCT00626925|OG001|Outcome|Total Placebo Group|"Inactive placebo matched in appearance with topiramate capsules~Placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913764|NCT00626925|OG002|Outcome|3 Month Post Treatment Topiramate Group|Mean Standard Drinks Per Day, 3 months post treatment
10913765|NCT00626925|OG003|Outcome|3 Month Post Treatment Placebo Group|Mean Standard Drinks Per Day, 3 months post treatment
10913766|NCT00626925|OG004|Outcome|6 Month Post Treatment Topiramate Group|Mean Standard Drinks Per Day, 6 months post treatment
10913767|NCT00626925|OG005|Outcome|6 Month Post Treatment Placebo Group|Mean Standard Drinks Per Day, 6 months post treatment
10913768|NCT00626925|OG000|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913769|NCT00626925|OG001|Outcome|Placebo CC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913770|NCT00626925|OG002|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913771|NCT00626925|OG003|Outcome|Placebo AC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913772|NCT00626925|OG004|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913773|NCT00626925|OG005|Outcome|Placebo AA Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913774|NCT00626925|OG000|Outcome|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
11335651|NCT03554486|EG001|Reported Event|Fiasp Insulin|Participants with events occurring during Fiasp insulin treatment.
11335652|NCT03554486|EG002|Reported Event|Novolog Insulin|Participants with events occurring during Novolog insulin treatment.
10913775|NCT00626925|OG001|Outcome|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913776|NCT00626925|EG000|Reported Event|Topiramate Group|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913777|NCT00626925|EG001|Reported Event|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
10913778|NCT00627016|BG000|Baseline|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
10913779|NCT00627016|BG001|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
10913780|NCT00627016|BG002|Baseline|Total|Total of all reporting groups
10913781|NCT00627016|FG000|Participant Flow|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
10913782|NCT00627016|FG001|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
10913783|NCT00627016|OG000|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
10913784|NCT00627016|OG001|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
10913785|NCT00627016|EG000|Reported Event|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
10913786|NCT00627016|EG001|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
10913787|NCT00627042|BG000|Baseline|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
10913788|NCT00627042|FG000|Participant Flow|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
10913789|NCT00627042|OG000|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
10913790|NCT00627042|EG000|Reported Event|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
10913791|NCT00627094|BG000|Baseline|Biatain Ibu|Biatain foam dressing containing ibuprofen
10913792|NCT00627094|BG001|Baseline|Biatain|Biatain foam dressing without ibuprofen - control
10913793|NCT00627094|BG002|Baseline|Total|Total of all reporting groups
10913794|NCT00627094|FG000|Participant Flow|Biatain Ibu|Biatain foam dressing containing Ibuprofen
10913795|NCT00627094|FG001|Participant Flow|Biatain|Biatain Foam dressing without ibuprofen - control
10913796|NCT00627094|OG000|Outcome|Biatain Ibu|Biatain foam dressing containing ibuprofen
10913797|NCT00627094|OG001|Outcome|Biatain|Biatain foam dressing without ibuprofen - control
10913798|NCT00627094|OG000|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
10913799|NCT00627094|OG001|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
10913800|NCT00627094|EG000|Reported Event|Biatain Ibu|Biatain foam dressing containing ibuprofen
10913801|NCT00627094|EG001|Reported Event|Biatain|Biatain foam dressing without ibuprofen
10913802|NCT00627367|BG000|Baseline|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
10913803|NCT00627367|BG001|Baseline|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
10913804|NCT00627367|BG002|Baseline|Total|Total of all reporting groups
10913805|NCT00627367|FG000|Participant Flow|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
10913806|NCT00627367|FG001|Participant Flow|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
10913807|NCT00627367|OG000|Outcome|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
10913808|NCT00627367|OG001|Outcome|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
10913809|NCT00627367|OG001|Outcome|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician. For this subanalysis, only patients who received IV morphine are analyzed"
10913810|NCT00627367|EG000|Reported Event|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
10913811|NCT00627367|EG001|Reported Event|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
10913812|NCT00627393|BG000|Baseline|Control Arm|Received antimicrobial therapy alone.
10913813|NCT00627393|BG001|Baseline|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
10913814|NCT00627393|BG002|Baseline|Total|Total of all reporting groups
10913815|NCT00627393|FG000|Participant Flow|Control Arm|Received antimicrobial therapy alone.
10913816|NCT00627393|FG001|Participant Flow|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
10913817|NCT00627393|OG000|Outcome|Control Arm|Received antimicrobial therapy alone.
10913818|NCT00627393|OG001|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
10913819|NCT00627393|OG000|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone~G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.~Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
10913820|NCT00627393|OG000|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
10913821|NCT00627393|EG000|Reported Event|Control Arm|Received antimicrobial therapy alone.
10913822|NCT00627393|EG001|Reported Event|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
10913823|NCT00627406|BG000|Baseline|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
10913824|NCT00627406|BG001|Baseline|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
10913825|NCT00627406|BG002|Baseline|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
10913826|NCT00627406|BG003|Baseline|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
10913827|NCT00627406|BG004|Baseline|Total|Total of all reporting groups
10913828|NCT00627406|FG000|Participant Flow|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
10913829|NCT00627406|FG001|Participant Flow|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
10913830|NCT00627406|FG002|Participant Flow|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
10913831|NCT00627406|FG003|Participant Flow|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
10913832|NCT00627406|OG000|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
10913833|NCT00627406|OG001|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
10913834|NCT00627406|OG002|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
10913835|NCT00627406|OG003|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
10913836|NCT00627406|EG000|Reported Event|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
10913837|NCT00627406|EG001|Reported Event|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
10913838|NCT00627406|EG002|Reported Event|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
10913839|NCT00627406|EG003|Reported Event|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
10913840|NCT00627445|BG000|Baseline|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
10913841|NCT00627445|BG001|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
10913842|NCT00627445|BG002|Baseline|Total|Total of all reporting groups
10913843|NCT00627445|FG000|Participant Flow|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
10913844|NCT00627445|FG001|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
10913845|NCT00627445|OG000|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
10913846|NCT00627445|OG001|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
10913847|NCT00627445|OG000|Outcome|BIAsp 50-50-30|Individually adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch in combination with metformin (500-2000 mg up to three times daily)
10913848|NCT00627445|OG001|Outcome|BIAsp 30-30|Individually adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin (500-2000 mg up to three times daily)
10913849|NCT00627445|EG000|Reported Event|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
10913850|NCT00627445|EG001|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
10913851|NCT00627458|BG000|Baseline|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913852|NCT00627458|BG001|Baseline|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
11091751|NCT01536145|OG000|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091752|NCT01536145|OG001|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10913853|NCT00627458|BG002|Baseline|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913854|NCT00627458|BG003|Baseline|Total|Total of all reporting groups
10913855|NCT00627458|FG000|Participant Flow|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913856|NCT00627458|FG001|Participant Flow|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913857|NCT00627458|FG002|Participant Flow|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913858|NCT00627458|OG000|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913859|NCT00627458|OG001|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913860|NCT00627458|OG000|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913861|NCT00627458|OG002|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10915162|NCT00634244|FG000|Participant Flow|Arm A (Carboplatin and Topotecan Hydrochloride)|"Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.~carboplatin: Given IV~topotecan hydrochloride: Given IV"
10913862|NCT00627458|EG000|Reported Event|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913863|NCT00627458|EG001|Reported Event|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913864|NCT00627458|EG002|Reported Event|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
10913865|NCT00627497|BG000|Baseline|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
10913866|NCT00627497|BG001|Baseline|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
10913867|NCT00627497|BG002|Baseline|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
10913868|NCT00627497|BG003|Baseline|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
10913869|NCT00627497|BG004|Baseline|Total|Total of all reporting groups
10913870|NCT00627497|FG000|Participant Flow|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
10913871|NCT00627497|FG001|Participant Flow|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
10913872|NCT00627497|FG002|Participant Flow|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
10913873|NCT00627497|FG003|Participant Flow|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
10913874|NCT00627497|OG000|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
10913875|NCT00627497|OG001|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
10913876|NCT00627497|OG002|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
10913877|NCT00627497|OG003|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
10913878|NCT00627497|EG000|Reported Event|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
10913879|NCT00627497|EG001|Reported Event|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
10913880|NCT00627497|EG002|Reported Event|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
10913881|NCT00627497|EG003|Reported Event|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
10913882|NCT00627523|BG000|Baseline|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
10913883|NCT00627523|BG001|Baseline|Control|This group was the untreated control group and was not administered placebo.
10913884|NCT00627523|BG002|Baseline|Total|Total of all reporting groups
10913885|NCT00627523|FG000|Participant Flow|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
10913886|NCT00627523|FG001|Participant Flow|Control|This group was the untreated control group and was not administered placebo.
10913887|NCT00627523|OG000|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
10913888|NCT00627523|OG001|Outcome|Control|This group was the untreated control group and was not administered placebo.
10913889|NCT00627523|EG000|Reported Event|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
10913890|NCT00627523|EG001|Reported Event|Control|This group was the untreated control group and was not administered placebo.
10913891|NCT00627679|BG000|Baseline|All Patients|All patients that were enrolled in the study.
10913892|NCT00627679|FG000|Participant Flow|Treatment A, B, D, C|Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5
10915163|NCT00634244|FG001|Participant Flow|Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)|"Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
11357171|NCT03763929|EG001|Reported Event|Placebo|"The placebo consists of commercially available sterile saline. Placebo will be administered intravenously as a bolus to subjects randomized to placebo. The volume of sterile saline will be based on the estimated subject weight.~Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance."
11357172|NCT03763747|BG000|Baseline|Scoreflex NC Scoring PTCA Catheter|"Single arm with investigational Scoreflex NC Scoring PTCA catheters~Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters"
11357173|NCT03763747|FG000|Participant Flow|Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter|"Single arm with investigational Scoreflex NC Scoring PTCA catheters~Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters"
11357174|NCT03763747|OG000|Outcome|Scoreflex NC Scoring PTCA Catheter|"Single arm with investigational Scoreflex NC Scoring PTCA catheters~Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters"
11357175|NCT03763747|EG000|Reported Event|Scoreflex NC Scoring PTCA Catheter|"Single arm with investigational Scoreflex NC Scoring PTCA catheters~Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters"
11357176|NCT03763175|BG000|Baseline|SYN-010 21 mg|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (21 mg PO QD). Study activities will be the same across all three arms.~SYN-010 21 mg: 21 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11357177|NCT03763175|BG001|Baseline|SYN-010 42 mg|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (42 mg PO QD). Study activities will be the same across all three arms.~SYN-010 42 mg: 42 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11357178|NCT03763175|BG002|Baseline|Placebo|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of placebo. Study activities will be the same across all three arms.~Placebo: A placebo will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11091753|NCT01536145|OG002|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11357179|NCT03763175|BG003|Baseline|Total|Total of all reporting groups
11357180|NCT03763175|FG000|Participant Flow|SYN-010 21 mg|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (21 mg PO QD). Study activities will be the same across all three arms.~SYN-010 21 mg: 21 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11357181|NCT03763175|FG001|Participant Flow|SYN-010 42 mg|"Enrolled subjects will be screened and randomized into the three study arms in a 1:1:1 ratio. 50 subjects with constipation-predominant irritable bowel syndrome (IBS-C) will be administered a 12-week course of lovastatin (42 mg PO QD). Study activities will be the same across all three arms.~SYN-010 42 mg: 42 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels."
11357461|NCT03757234|FG003|Participant Flow|Omadacycline 200 iv/450 po or 100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
10913893|NCT00627679|FG001|Participant Flow|Treatment B, C, A, D|Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
10913894|NCT00627679|FG002|Participant Flow|Treatment C, D, B, A|Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 5
10913895|NCT00627679|FG003|Participant Flow|Treatment D, A, C, B|Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5
10913896|NCT00627679|OG000|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
10913897|NCT00627679|OG001|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
10913898|NCT00627679|OG002|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
10913899|NCT00627679|OG003|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
10913900|NCT00627679|EG000|Reported Event|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
10913901|NCT00627679|EG001|Reported Event|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
11233671|NCT02430337|FG000|Participant Flow|SafeCare- Intervention as Usual (SC-IU)|The SC-IU condition followed the protocol used in standard SafeCare implementation, which includes the following phases: (1) Agency readiness-NSTRC reviews the requisite organizational communication, service system and SafeCare funding plan, implementation requirements, and budgetary information with interested agencies to ensure fit of SafeCare within the organizational context of the agency, (2) SafeCare workshop training-This includes a 4-day classroom-based training that involves didactic presentations, modeling of the instruction, and role-playing for SafeCare trainees as well as structured assessments of the skills taught, (3) SafeCare provider certification process-Providers receive support from NSTRC as they begin SafeCare delivery with families. The support includes the SafeCare trainers listening to audio recordings of the providers' SafeCare sessions, assessing these sessions for fidelity, and then providing a follow-up coaching session to provide feedback to
11335653|NCT03554629|BG000|Baseline|Capnography CO2 Sampling Filterline|Capnography CO2 Sampling Filterline: Use of up to 8 Capnography CO2 Sampling FIlterlines by blinded code name during scripted activities
11335654|NCT03554629|FG000|Participant Flow|Eight Capnography CO2 Sampling Filterline Performance|"Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities for data analysis.~All subjects worn all 8 CCSF devices under test for the four study activities.~1 and 2. Closed mouth breathing with respiration rate of 6 and 24 3 and 4. Open mouth breathing with respiration rate at 6 and 24"
10913902|NCT00627679|EG002|Reported Event|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
10913903|NCT00627679|EG003|Reported Event|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
10913904|NCT00627705|BG000|Baseline|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
10913905|NCT00627705|BG001|Baseline|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
10913906|NCT00627705|BG002|Baseline|Total|Total of all reporting groups
10913907|NCT00627705|FG000|Participant Flow|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
10913908|NCT00627705|FG001|Participant Flow|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
10913909|NCT00627705|OG000|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
10913910|NCT00627705|OG001|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
10913911|NCT00627705|EG000|Reported Event|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
10913912|NCT00627705|EG001|Reported Event|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
10913913|NCT00627861|BG000|Baseline|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
10913914|NCT00627861|FG000|Participant Flow|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
10913915|NCT00627861|OG000|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
10913916|NCT00627861|OG000|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks.
10913917|NCT00627861|OG000|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks
10913918|NCT00627861|EG000|Reported Event|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
10913919|NCT00627926|BG000|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10913920|NCT00627926|BG001|Baseline|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
10913921|NCT00627926|BG002|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
10913922|NCT00627926|BG003|Baseline|Total|Total of all reporting groups
10913923|NCT00627926|FG000|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10913924|NCT00627926|FG001|Participant Flow|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
10913925|NCT00627926|FG002|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
10913926|NCT00627926|OG000|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10913927|NCT00627926|OG001|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
10913928|NCT00627926|OG002|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
10913929|NCT00627926|EG000|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
10913930|NCT00627926|EG001|Reported Event|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
10913931|NCT00627926|EG002|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
10913932|NCT00627978|BG000|Baseline|Ixabepilone|"Participants are treated with Ixabepilone.~ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
10913933|NCT00627978|BG001|Baseline|Control|Participants receive no intervention.
10913934|NCT00627978|BG002|Baseline|Total|Total of all reporting groups
10913935|NCT00627978|FG000|Participant Flow|Ixabepilone|"Participants are treated with Ixabepilone.~ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
10913936|NCT00627978|FG001|Participant Flow|Control|No treatment with Ixabepilone
10913937|NCT00627978|OG000|Outcome|Ixabepilone|"Participants are treated with Ixabepilone.~ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
10913938|NCT00627978|OG001|Outcome|Control|No treatment with Ixabepilone
10913939|NCT00627978|EG000|Reported Event|Ixabepilone|"Participants are treated with Ixabepilone.~ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
10913940|NCT00627978|EG001|Reported Event|Control|Participants are not treated with Ixabepilone.
10913941|NCT00628030|BG000|Baseline|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
10913942|NCT00628030|BG001|Baseline|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
10913943|NCT00628030|BG002|Baseline|Total|Total of all reporting groups
10913944|NCT00628030|FG000|Participant Flow|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
10913945|NCT00628030|FG001|Participant Flow|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
10913946|NCT00628030|OG000|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
10913947|NCT00628030|OG001|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
10913948|NCT00628030|EG000|Reported Event|NOURISH|The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. The interventions differed only in duration. They covered the same concepts which are grounded in Social Cognitive Theory (SCT). Throughout the interventions the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics provided information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
10913949|NCT00628030|EG001|Reported Event|Wellness Group|The placebo control group attended a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, parents received pedometers for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.Followed up for 6 months.
10913950|NCT00628108|BG000|Baseline|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10913951|NCT00628108|BG001|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10913952|NCT00628108|BG002|Baseline|Total|Total of all reporting groups
11335462|NCT03550989|FG001|Participant Flow|Cigarette Smokers|"Each participant can participate in one Non-Exposure Event and one Exposure Event only.~Used at least 100 cigarettes~Smokes cigarettes daily > 1/day~Uses IQOS less than daily~Uses less than 30 HeatSticks/month~Cigarette is > 95% of tobacco/nicotine product (all product use)~Non-Exposure Event: Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.~Exposure Event: Exposure Event to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS)."
10913953|NCT00628108|FG000|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10913954|NCT00628108|FG001|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10913955|NCT00628108|OG000|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10913956|NCT00628108|OG001|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10913957|NCT00628108|EG000|Reported Event|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10913958|NCT00628108|EG001|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
10913959|NCT00628134|BG000|Baseline|Cystic Fibrosis Subjects|"Subjects with cystic fibrosis~isotonic saline aerosol : single inhaled dose, 3ml by nebulizer~calfactant aerosol : single inhaled dose, 3ml by nebulizer"
10913960|NCT00628134|FG000|Participant Flow|Surfactant Aerosol Then Saline Aerosol|cystic fibrosis patients who inhaled surfactant aerosol at the first study visit and saline aerosol at the second study visit
10913961|NCT00628134|FG001|Participant Flow|Saline Aerosol Then Surfactant Aerosol|cystic fibrosis patients who inhaled saline aerosol at the first study visit and surfactant aerosol at the second study visit
10913962|NCT00628134|OG000|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
10913963|NCT00628134|OG001|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
10913964|NCT00628134|EG000|Reported Event|Subjects Inhaling Saline|Subjects with cystic fibrosis
11357462|NCT03757234|FG004|Participant Flow|Levofloxacin 750 iv/750 po or iv|On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
10913965|NCT00628134|EG001|Reported Event|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
10913966|NCT00628147|BG000|Baseline|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
10913967|NCT00628147|BG001|Baseline|White Light|Conventional White Light Examination
10913968|NCT00628147|BG002|Baseline|Total|Total of all reporting groups
10913969|NCT00628147|FG000|Participant Flow|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
10913970|NCT00628147|FG001|Participant Flow|White Light|Conventional White Light Examination
10913971|NCT00628147|OG000|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
10913972|NCT00628147|OG001|Outcome|White Light|Conventional White Light Examination
10913973|NCT00628147|EG000|Reported Event|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
10913974|NCT00628147|EG001|Reported Event|White Light|Conventional White Light Examination
10913975|NCT00628212|BG000|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
10913976|NCT00628212|BG001|Baseline|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
10913977|NCT00628212|BG002|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
10913978|NCT00628212|BG003|Baseline|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
10913979|NCT00628212|BG004|Baseline|Total|Total of all reporting groups
10913980|NCT00628212|FG000|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
10913981|NCT00628212|FG001|Participant Flow|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
10913982|NCT00628212|FG002|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
10913983|NCT00628212|FG003|Participant Flow|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
10913984|NCT00628212|OG000|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
10913985|NCT00628212|OG001|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
10913986|NCT00628212|OG002|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
10913987|NCT00628212|OG003|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
10913988|NCT00628212|EG000|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
10913989|NCT00628212|EG001|Reported Event|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
10913990|NCT00628212|EG002|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
10913991|NCT00628212|EG003|Reported Event|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
10913992|NCT00628251|BG000|Baseline|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
10913993|NCT00628251|BG001|Baseline|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
10913994|NCT00628251|BG002|Baseline|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
10913995|NCT00628251|BG003|Baseline|Total|Total of all reporting groups
10913996|NCT00628251|FG000|Participant Flow|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
10913997|NCT00628251|FG001|Participant Flow|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
11335509|NCT03551743|EG002|Reported Event|Module 4 (800 mg Bolus + 480 mg Infusion)|800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
10913998|NCT00628251|FG002|Participant Flow|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
10913999|NCT00628251|OG000|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
10914000|NCT00628251|OG001|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
10914001|NCT00628251|OG002|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
10914002|NCT00628251|OG002|Outcome|Olaparib 200 mg bd + Olaparib 400 mg bd,|Olaparib (AZD2281) 200 or 400 mg oral capsules twice daily
10914003|NCT00628251|OG003|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
10914004|NCT00628251|EG000|Reported Event|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
10914005|NCT00628251|EG001|Reported Event|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
10914006|NCT00628251|EG002|Reported Event|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
10914007|NCT00628355|BG000|Baseline|Ischemic Compression|Group received TENS plus Ischemic compression
10914008|NCT00628355|BG001|Baseline|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
10914009|NCT00628355|BG002|Baseline|Total|Total of all reporting groups
10914010|NCT00628355|FG000|Participant Flow|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
10914011|NCT00628355|FG001|Participant Flow|Anesthesia Injection|Group received lidocaine injection
10914012|NCT00628355|OG000|Outcome|Ischemic Compression|Group received ischemic compression
10914013|NCT00628355|OG001|Outcome|Anesthesia Injection|Group received lidocaine injection
10914014|NCT00628355|OG000|Outcome|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
10914015|NCT00628355|EG000|Reported Event|Ischemic Compression|Group received Ischemic compression
10914016|NCT00628355|EG001|Reported Event|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
10914017|NCT00628394|BG000|Baseline|Atomox/CR|"Patients are given the drug Atomoxetine and Cognitive Remediation training.~Atomoxetine: 40mg 2po qam"
10914018|NCT00628394|BG001|Baseline|Atomox/Control|"Patients are given the drug Atomoxetine and Remediation Control training.~Atomoxetine: 40mg 2po qam"
10914019|NCT00628394|BG002|Baseline|Placebo/CR|"Patients are given a Placebo and Cognitive Remediation training.~Placebo: 40mg 2po qam"
10914020|NCT00628394|BG003|Baseline|Placebo/Control|"Patients are given Placebo and Remediation Control training.~Placebo: 40mg 2po qam"
10914021|NCT00628394|BG004|Baseline|Total|Total of all reporting groups
10914022|NCT00628394|FG000|Participant Flow|Atomox/CR|"Patients are given the drug Atomoxetine and Cognitive Remediation training.~Atomoxetine: 40mg 2po qam"
10914023|NCT00628394|FG001|Participant Flow|Atomox/Control|"Patients are given the drug Atomoxetine and Remediation Control training.~Atomoxetine: 40mg 2po qam"
10914024|NCT00628394|FG002|Participant Flow|Placebo/CR|"Patients are given a Placebo and Cognitive Remediation training.~Placebo: 40mg 2po qam"
10914025|NCT00628394|FG003|Participant Flow|Placebo/Control|"Patients are given Placebo and Remediation Control training.~Placebo: 40mg 2po qam"
10914026|NCT00628394|OG000|Outcome|Atomox/CR|"Patients are given the drug Atomoxetine and Cognitive Remediation training.~Atomoxetine: 40mg 2po qam"
10914027|NCT00628394|OG001|Outcome|Atomox/Control|"Patients are given the drug Atomoxetine and Remediation Control training.~Atomoxetine: 40mg 2po qam"
10914028|NCT00628394|OG002|Outcome|Placebo/CR|"Patients are given a Placebo and Cognitive Remediation training.~Placebo: 40mg 2po qam"
10914029|NCT00628394|OG003|Outcome|Placebo/Control|"Patients are given Placebo and Remediation Control training.~Placebo: 40mg 2po qam"
10914030|NCT00628394|EG000|Reported Event|Atomox/CR|"Patients are given the drug Atomoxetine and Cognitive Remediation training.~Atomoxetine: 40mg 2po qam"
10914031|NCT00628394|EG001|Reported Event|Atomox/Control|"Patients are given the drug Atomoxetine and Remediation Control training.~Atomoxetine: 40mg 2po qam"
10914032|NCT00628394|EG002|Reported Event|Placebo/CR|"Patients are given a Placebo and Cognitive Remediation training.~Placebo: 40mg 2po qam"
10914033|NCT00628394|EG003|Reported Event|Placebo/Control|"Patients are given Placebo and Remediation Control training.~Placebo: 40mg 2po qam"
10914034|NCT00628407|BG000|Baseline|Sternal Wall Pressure|
10914035|NCT00628407|FG000|Participant Flow|Sternal Wall Pressure|Subjects that received gentle incremental sternal wall pressure.
10914036|NCT00628407|OG000|Outcome|Sternal Wall Pressure|
10914037|NCT00628407|EG000|Reported Event|Sternal Wall Pressure|
10914038|NCT00628498|BG000|Baseline|Defibrotide|Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
10914039|NCT00628498|FG000|Participant Flow|Defibrotide|Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
10914040|NCT00628498|OG000|Outcome|Defibrotide|Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
11335510|NCT03551743|EG003|Reported Event|Module 4 (800 mg)|800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
11335511|NCT03551821|BG000|Baseline|ATI-50002 Topical Solution|"ATI-50002 Topical Solution~ATI-50002: Topical Solution"
11335512|NCT03551821|FG000|Participant Flow|ATI-50002 Topical Solution|ATI-50002 Topical Solution
10914041|NCT00628498|EG000|Reported Event|Defibrotide|Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
10914042|NCT00628589|BG000|Baseline|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
10914043|NCT00628589|BG001|Baseline|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
10914044|NCT00628589|BG002|Baseline|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
10914045|NCT00628589|BG003|Baseline|Total|Total of all reporting groups
10914046|NCT00628589|FG000|Participant Flow|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
10914047|NCT00628589|FG001|Participant Flow|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
10914048|NCT00628589|FG002|Participant Flow|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
10914049|NCT00628589|OG000|Outcome|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
10914050|NCT00628589|OG001|Outcome|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
10914051|NCT00628589|OG002|Outcome|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
10914052|NCT00628589|EG000|Reported Event|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
10914053|NCT00628589|EG001|Reported Event|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
11091754|NCT01536145|OG003|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091755|NCT01536145|OG004|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11357463|NCT03757234|OG000|Outcome|Omadacycline 200 iv/200 iv|On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
10914054|NCT00628589|EG002|Reported Event|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
10914055|NCT00628628|BG000|Baseline|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
10914056|NCT00628628|BG001|Baseline|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
10914057|NCT00628628|BG002|Baseline|Total|Total of all reporting groups
10914058|NCT00628628|FG000|Participant Flow|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
10914059|NCT00628628|FG001|Participant Flow|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
10914060|NCT00628628|OG000|Outcome|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
10914061|NCT00628628|OG001|Outcome|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
10914062|NCT00628628|EG000|Reported Event|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
10914063|NCT00628628|EG001|Reported Event|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
10914064|NCT00628758|BG000|Baseline|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
10914065|NCT00628758|BG001|Baseline|Conventional BP|Conventional Best Practice for Treatment of asthma
10914066|NCT00628758|BG002|Baseline|Total|Total of all reporting groups
10914067|NCT00628758|FG000|Participant Flow|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
10914068|NCT00628758|FG001|Participant Flow|Conventional BP|Conventional Best Practice for Treatment of asthma
10914069|NCT00628758|OG000|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
10914070|NCT00628758|OG001|Outcome|Conventional Best Practice (BP)|Conventional Best Practice for Treatment of asthma
10914071|NCT00628758|OG000|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
10914072|NCT00628758|OG001|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
10914073|NCT00628758|EG000|Reported Event|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
10914074|NCT00628758|EG001|Reported Event|Conventional BP|Conventional Best Practice for Treatment of asthma
10914075|NCT00628862|BG000|Baseline|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
10914076|NCT00628862|BG001|Baseline|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
10914077|NCT00628862|BG002|Baseline|Placebo|Placebo
10914078|NCT00628862|BG003|Baseline|Total|Total of all reporting groups
10914079|NCT00628862|FG000|Participant Flow|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
10914080|NCT00628862|FG001|Participant Flow|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
10914081|NCT00628862|FG002|Participant Flow|Placebo|Placebo
10914082|NCT00628862|OG000|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
10914083|NCT00628862|OG001|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
10914084|NCT00628862|OG002|Outcome|Placebo|Placebo
10914085|NCT00628862|EG000|Reported Event|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
10914086|NCT00628862|EG001|Reported Event|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
10914087|NCT00628862|EG002|Reported Event|Placebo|Placebo
10914088|NCT00628901|BG000|Baseline|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
11091756|NCT01536145|OG005|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
11091757|NCT01536145|OG006|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10914089|NCT00628901|BG001|Baseline|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
10914090|NCT00628901|BG002|Baseline|Total|Total of all reporting groups
10914091|NCT00628901|FG000|Participant Flow|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
10914092|NCT00628901|FG001|Participant Flow|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
10914093|NCT00628901|OG000|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
10914094|NCT00628901|OG001|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
10914095|NCT00628901|EG000|Reported Event|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
10914096|NCT00628901|EG001|Reported Event|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
10914097|NCT00628927|BG000|Baseline|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
10914098|NCT00628927|BG001|Baseline|Normal Control Participants|Normal Control participants recruited from the community
10914099|NCT00628927|BG002|Baseline|Total|Total of all reporting groups
10914100|NCT00628927|FG000|Participant Flow|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
10914101|NCT00628927|FG001|Participant Flow|Normal Control Participants|Normal Control participants recruited from the community
10914102|NCT00628927|OG000|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week
11357464|NCT03757234|OG001|Outcome|Omadacycline 200 iv/100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
10914103|NCT00628927|OG001|Outcome|Stimulant Dependent Treatment Non-Completers|Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for the two ineligible but enrolled participants was removed from the analysis.
10914104|NCT00628927|OG000|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week Data from one participant was excluded from analysis due to lack of completeness
10914105|NCT00628927|OG001|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data from the two ineligible by enrolled participants was removed from the analysis.~Data from 3 other participants was incomplete and therefore removed from the analysis."
10914106|NCT00628927|OG000|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week 3 participant samples were insufficient for analysis
10914107|NCT00628927|OG001|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for 2 participants who were ineligible but enrolled were removed from analysis 1 participant did not complete the blood draw~1 participant sample was insufficient for analysis"
10914108|NCT00628927|OG002|Outcome|Normal Controls|Normal controls recruited from the community.
10914109|NCT00628927|EG000|Reported Event|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
10914110|NCT00628927|EG001|Reported Event|Normal Control Participants|Normal Control participants recruited from the community
10914111|NCT00629018|BG000|Baseline|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
10914112|NCT00629018|BG001|Baseline|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
10914113|NCT00629018|BG002|Baseline|Total|Total of all reporting groups
10914114|NCT00629018|FG000|Participant Flow|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
10914115|NCT00629018|FG001|Participant Flow|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
10914116|NCT00629018|OG000|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
10914117|NCT00629018|OG001|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
10914118|NCT00629018|EG000|Reported Event|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
10914119|NCT00629018|EG001|Reported Event|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
10914120|NCT00629083|BG000|Baseline|Bulkamid Hydrogel Injection|Bulkamid: Bulking injection with Bulkamid injection device
10914121|NCT00629083|BG001|Baseline|Contigen Injection|Contigen: Transurethral bulking injection
10914122|NCT00629083|BG002|Baseline|Total|Total of all reporting groups
10914123|NCT00629083|FG000|Participant Flow|Bulkamid Hydrogel|Bulkamid hydrogel is a proprietary, cross-linked polyacrylamide hydrogel developed for urethral bulking. The hydrogel consists of a backbone of cross-linked polyacrylamide, with water molecules loosely bound to the polymer matrix.
10914124|NCT00629083|FG001|Participant Flow|Contigen Injection|Contigen is a sterile non-pyrogenic implantable device composed of highly purified bovine dermal collagen that was lightly crosslinked with glutaraldehyde and dispersed in phosphate-buffered physiological saline
10914125|NCT00629083|OG000|Outcome|Bulkamid Hydrogel Injection|Bulkamid: Bulking injection with Bulkamid injection device
10914126|NCT00629083|OG001|Outcome|Contigen Injection|Contigen: Transurethral bulking injection
10914127|NCT00629083|OG000|Outcome|Treament|"Bulkamid Hydrogel injection~Bulkamid: Bulking injection with Bulkamid injection device"
10914128|NCT00629083|OG001|Outcome|Control|"Contigen injection~Contigen: Transurethral bulking injection"
10914129|NCT00629083|EG000|Reported Event|Bulkamid Hydrogel Injection|Bulkamid: Bulking injection with Bulkamid injection device
10914130|NCT00629083|EG001|Reported Event|Contigen Injection|Contigen: Transurethral bulking injection
10914131|NCT00629122|BG000|Baseline|Arm A (Tacrolimus and Nystatin)|Sublingual (SL) tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral (PO) tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
10914132|NCT00629122|BG001|Baseline|Arm B (Tacrolimus and Clotrimazole)|Sublingual (SL) tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral (PO) tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
10914133|NCT00629122|BG002|Baseline|Total|Total of all reporting groups
10914134|NCT00629122|FG000|Participant Flow|Arm A (Tacrolimus and Nystatin)|"Sublingual (SL) tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral (PO) tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).~Study day 1: Initiate SL tacrolimus and nystatin suspension x 5 doses. Study day 3: Collection of pharmacokinetic parameters around 5th SL tacrolimus dose.~Study day 3: Start washout period, no drug administration (tacrolimus, nystatin).~Study day 5: End washout period. Study day 6: Initiate PO tacrolimus and nystatin suspension x 5 doses. Study day 8: Collection of pharmacokinetic parameters around the 5th PO tacrolimus dose.~Study day 15: Participants will be contacted by telephone to assess for any adverse effects."
10914135|NCT00629122|FG001|Participant Flow|Arm B (Tacrolimus and Clotrimazole)|"Sublingual (SL) tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral (PO) tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).~Study day 1: Initiate SL tacrolimus and clotrimazole troche x 5 doses. Study day 3: Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose.~Study day 3: Start washout period, no drug administration (tacrolimus, clotrimazole).~Study day 5: End washout period.~Study day 6: Initiate PO tacrolimus and clotrimazole troche x 5 doses. Study day 8: Collection of pharmacokinetic parameters around the 5th PO tacrolimus dose.~Study day 15: Participants will be contacted by telephone to assess for any adverse effects."
10914136|NCT00629122|OG000|Outcome|Arm A (Tacrolimus and Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
10914137|NCT00629122|OG001|Outcome|Arm B (Tacrolimus and Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
10914138|NCT00629122|EG000|Reported Event|Arm A (Tacrolimus + Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
10914139|NCT00629122|EG001|Reported Event|Arm B (Tacrolimus + Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
10914140|NCT00629239|BG000|Baseline|AZD4818|AZD4818 Turbuhaler
10914141|NCT00629239|BG001|Baseline|Placebo|Placebo
10914142|NCT00629239|BG002|Baseline|Total|Total of all reporting groups
10914143|NCT00629239|FG000|Participant Flow|AZD4818|AZD4818 Turbuhaler
10914144|NCT00629239|FG001|Participant Flow|Placebo|Placebo
10914145|NCT00629239|OG000|Outcome|AZD4818|AZD4818 Turbuhaler
10914146|NCT00629239|OG001|Outcome|Placebo|Placebo
10914147|NCT00629239|EG000|Reported Event|AZD4818|AZD4818 Turbuhaler
10914148|NCT00629239|EG001|Reported Event|Placebo|Placebo
10914149|NCT00629265|BG000|Baseline|Active NMES Group|NMES therapy combined with exercise therapy
10914150|NCT00629265|BG001|Baseline|Sham NMES Group|Sham NMES combined with exercise therapy
10914151|NCT00629265|BG002|Baseline|Total|Total of all reporting groups
11335513|NCT03551821|OG000|Outcome|ATI-50002 Topical Solution|ATI-50002 Topical Solution
10914152|NCT00629265|FG000|Participant Flow|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
10914153|NCT00629265|FG001|Participant Flow|Sham NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
10914154|NCT00629265|OG000|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
10914155|NCT00629265|OG001|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
10914156|NCT00629265|EG000|Reported Event|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
10914157|NCT00629265|EG001|Reported Event|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
10914158|NCT00629499|BG000|Baseline|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
10914159|NCT00629499|FG000|Participant Flow|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
10914160|NCT00629499|OG000|Outcome|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
10914161|NCT00629499|EG000|Reported Event|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
10914162|NCT00629525|BG000|Baseline|RAD001|RAD001 at a dose of 10 mg PO daily
10914163|NCT00629525|FG000|Participant Flow|RAD001|RAD001 at a dose of 10 mg PO daily
10914164|NCT00629525|OG000|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
10914165|NCT00629525|EG000|Reported Event|RAD001|RAD001 at a dose of 10 mg PO daily
10914166|NCT00629707|BG000|Baseline|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
10914167|NCT00629707|BG001|Baseline|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
11335514|NCT03551821|EG000|Reported Event|ATI-50002 Topical Solution|ATI-50002 Topical Solution
11335515|NCT03552198|BG000|Baseline|General Public/Usual Health Advice|Healthy participants with a self-reported existing health condition were randomised to receive the usual UK Air Quality Indices health advice.
10914168|NCT00629707|BG002|Baseline|Total|Total of all reporting groups
10914169|NCT00629707|FG000|Participant Flow|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
10914170|NCT00629707|FG001|Participant Flow|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
10914171|NCT00629707|OG000|Outcome|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
10914172|NCT00629707|OG001|Outcome|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
10914173|NCT00629707|EG000|Reported Event|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
10914174|NCT00629707|EG001|Reported Event|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
10914175|NCT00629772|BG000|Baseline|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
10914176|NCT00629772|BG001|Baseline|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
10914177|NCT00629772|BG002|Baseline|Total|Total of all reporting groups
10914178|NCT00629772|FG000|Participant Flow|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
10914179|NCT00629772|FG001|Participant Flow|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
10914180|NCT00629772|OG000|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
10914181|NCT00629772|OG001|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
10914182|NCT00629772|OG000|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
10914183|NCT00629772|EG000|Reported Event|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22 throughout the entire study.
10914184|NCT00629772|EG001|Reported Event|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
10914185|NCT00630032|BG000|Baseline|Docetaxel|"3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)~Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks"
10914186|NCT00630032|BG001|Baseline|Ixabepilone|"3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);~Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks"
10914187|NCT00630032|BG002|Baseline|Total|Total of all reporting groups
10914188|NCT00630032|FG000|Participant Flow|Docetaxel|"3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)~Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks"
10914189|NCT00630032|FG001|Participant Flow|Ixabepilone|"3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);~Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks"
10914190|NCT00630032|OG000|Outcome|Docetaxel|"3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)~Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks"
10914191|NCT00630032|OG001|Outcome|Ixabepilone|"3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);~Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks"
10914192|NCT00630032|EG000|Reported Event|Docetaxel|"3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)~Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks"
10914193|NCT00630032|EG001|Reported Event|Ixabepilone|"3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);~Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks"
10914194|NCT00630058|BG000|Baseline|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
10914195|NCT00630058|BG001|Baseline|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
10914196|NCT00630058|BG002|Baseline|Total|Total of all reporting groups
11091758|NCT01536145|OG007|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
10914197|NCT00630058|FG000|Participant Flow|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
10914198|NCT00630058|FG001|Participant Flow|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
10914199|NCT00630058|OG000|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
10914200|NCT00630058|OG001|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
10914201|NCT00630058|EG000|Reported Event|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
10914202|NCT00630058|EG001|Reported Event|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
10914203|NCT00630253|BG000|Baseline|Marrow Isolex|bone marrow processed using Isolex 300i (for patients enrolled through April 2010)
10914204|NCT00630253|BG001|Baseline|UCB Arm|No processing
10914205|NCT00630253|BG002|Baseline|Marrow Clinimax|bone marrow processed using CliniMACS (for patients enrolled beginning with the August 2010 protocol version)
10914206|NCT00630253|BG003|Baseline|Total|Total of all reporting groups
10914207|NCT00630253|FG000|Participant Flow|Marrow Isolex|bone marrow processed using Isolex 300i (for patients enrolled through April 2010)
10914208|NCT00630253|FG001|Participant Flow|Umbilical Cord Blood (UCB) Arm|No processing
10914209|NCT00630253|FG002|Participant Flow|Marrow Clinimax|bone marrow processed using CliniMACS (for patients enrolled beginning with the August 2010 protocol version)
10914210|NCT00630253|OG000|Outcome|Marrow Isolex|bone marrow processed using Isolex 300i (for patients enrolled through April 2010)
10914211|NCT00630253|OG001|Outcome|UCB Arm|No processing
10914212|NCT00630253|OG002|Outcome|Marrow Clinimax|bone marrow processed using CliniMACS (for patients enrolled beginning with the August 2010 protocol version)
10914213|NCT00630253|EG000|Reported Event|Marrow Isolex|bone marrow processed using Isolex 300i (for patients enrolled through April 2010)
10914214|NCT00630253|EG001|Reported Event|UCB Arm|No processing
10914215|NCT00630253|EG002|Reported Event|Marrow Clinimax|bone marrow processed using CliniMACS (for patients enrolled beginning with the August 2010 protocol version)
10914216|NCT00630305|BG000|Baseline|All Subjects|All subjects who were enrolled, randomized, and assigned to a study arm.
10914217|NCT00630305|FG000|Participant Flow|Overall|subjects were randomized to a session (A, B, C and D) and then to one of four lens sequences. Each subject participated in every session.
10914218|NCT00630305|OG000|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
10914219|NCT00630305|OG001|Outcome|Sequence 2|Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
10914220|NCT00630305|OG002|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
10914221|NCT00630305|OG003|Outcome|Sequence 4|Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
10914222|NCT00630305|OG000|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye.
10914223|NCT00630305|OG001|Outcome|Sequence 2|Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye.
10914224|NCT00630305|OG003|Outcome|Sequence 4|Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye.
10914225|NCT00630305|EG000|Reported Event|Session A|"Open eye session, this session includes the following sequences only:~senofilcon A / alphafilcon A~alphafilcon A / senofilcon A~senofilcon A / senofilcon A~alphafilcon A / alphafilcon A"
11335516|NCT03552198|BG001|Baseline|General Public/Alternative Health Advice|"Generally healthy participants were randomised to receive targeted health advice about the adoption of protective behaviours in an alternative format.~Alternative health advice: These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations."
10914226|NCT00630305|EG001|Reported Event|Session B|"Closed eye session, this session includes the following sequences only:~senofilcon A/ alphafilcon A~alphafilcon A/ senofilcon A~senofilcon A/ senofilcon A~alphafilcon A/ alphafilcon A"
10914227|NCT00630305|EG002|Reported Event|Session C|"Open eye session, this session includes the following sequences only:~senofilcon A/ lotrafilcon B~lotrafilcon B / senofilcon A~senofilcon A/ senofilcon A~lotrafilcon B / lotrafilcon B"
10914228|NCT00630305|EG003|Reported Event|Session D|"Closed eye session, this session includes the following sequences only:~senofilcon A/ lotrafilcon B~lotrafilcon B / senofilcon A~senofilcon A/ senofilcon A~lotrafilcon B / lotrafilcon B"
10914229|NCT00630331|BG000|Baseline|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
10914230|NCT00630331|BG001|Baseline|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
10914231|NCT00630331|BG002|Baseline|Placebo|One dose of phosphate buffered solution (PBS).
10914232|NCT00630331|BG003|Baseline|Total|Total of all reporting groups
10914233|NCT00630331|FG000|Participant Flow|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
10914234|NCT00630331|FG001|Participant Flow|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
10914235|NCT00630331|FG002|Participant Flow|Placebo|One dose of phosphate buffered solution (PBS).
10914236|NCT00630331|OG000|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
10914237|NCT00630331|OG001|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
10914238|NCT00630331|OG002|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
10914239|NCT00630331|EG000|Reported Event|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
10914240|NCT00630331|EG001|Reported Event|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
10914241|NCT00630331|EG002|Reported Event|Placebo|One dose of phosphate buffered solution (PBS).
10914242|NCT00630344|BG000|Baseline|RAD-001 in Combination With Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
10914243|NCT00630344|FG000|Participant Flow|RAD001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
10914244|NCT00630344|OG000|Outcome|RAD-001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
10914245|NCT00630344|OG000|Outcome|RAD001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
10914246|NCT00630344|EG000|Reported Event|RAD-001+ Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
10914247|NCT00630396|BG000|Baseline|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
10914248|NCT00630396|FG000|Participant Flow|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
10914249|NCT00630396|OG000|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
10914250|NCT00630396|EG000|Reported Event|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
11233672|NCT02430337|FG001|Participant Flow|SafeCare Technology-Assisted (SC-TA)|SafeCare providers assigned to the SC-TA condition participated in the standard SafeCare workshop and also received training in the technology-mediated approach to SafeCare delivery. The technology training took approximately 2 hr and focused on how the provider utilizes the technology in each session. Specifically, after greeting the parent, the provider was instructed to connect the parent to the web-based program, during which the parent participates in the multimodal learning (e.g., explanation and modeling of skills) of SafeCare target skills. When the parent completes the web-directed portion of the session, the provider is prompted by the web-based program to take over the session delivery, revisit any explanation and modeling the parent has questions about, and then engage the parent in live practice of the skills presented in the web program. Lastly, the provider offers positive and constructive feedback about the practice and closes the SafeCare session.
10914251|NCT00630409|BG000|Baseline|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
10914252|NCT00630409|FG000|Participant Flow|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
10914253|NCT00630409|OG000|Outcome|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
10914254|NCT00630409|OG000|Outcome|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8 + Doxil: 24 mg/m2 every 21 days IV"
10914255|NCT00630409|EG000|Reported Event|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
10914256|NCT00630539|BG000|Baseline|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
10914257|NCT00630539|BG001|Baseline|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
10914258|NCT00630539|BG002|Baseline|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
10914259|NCT00630539|BG003|Baseline|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
10914260|NCT00630539|BG004|Baseline|Total|Total of all reporting groups
10914261|NCT00630539|FG000|Participant Flow|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
10914262|NCT00630539|FG001|Participant Flow|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
10914263|NCT00630539|FG002|Participant Flow|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
10914264|NCT00630539|FG003|Participant Flow|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
10914265|NCT00630539|OG000|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
10914266|NCT00630539|OG001|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
10914267|NCT00630539|OG002|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
10914268|NCT00630539|OG003|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
10914269|NCT00630539|OG001|Outcome|Subjects on Placebo (Week 12)|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
10914270|NCT00630539|OG002|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
10914271|NCT00630539|OG003|Outcome|Subjects on Ospemifene 5 mg/Day (Week 12)|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
10914272|NCT00630539|OG004|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
10914273|NCT00630539|OG005|Outcome|Subjects on Ospemifine 15 mg/Day (Week 12)|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
10914274|NCT00630539|OG006|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
10914275|NCT00630539|OG007|Outcome|Subjects on Ospemifene 30 mg/Day (Week 12)|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
10914276|NCT00630539|EG000|Reported Event|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
10914277|NCT00630539|EG001|Reported Event|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
10914278|NCT00630539|EG002|Reported Event|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
10914279|NCT00630539|EG003|Reported Event|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
10914280|NCT00630734|BG000|Baseline|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914281|NCT00630734|BG001|Baseline|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914282|NCT00630734|BG002|Baseline|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914283|NCT00630734|BG003|Baseline|Total|Total of all reporting groups
10914284|NCT00630734|FG000|Participant Flow|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914285|NCT00630734|FG001|Participant Flow|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
10914286|NCT00630734|FG002|Participant Flow|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914287|NCT00630734|OG000|Outcome|SLCO1B1 Group 1|SLCO1B1*1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914288|NCT00630734|OG001|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914289|NCT00630734|OG002|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914290|NCT00630734|OG000|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
10914291|NCT00630734|OG001|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
10914292|NCT00630734|EG000|Reported Event|Pravastatin Alone|Pravastatin 40 mg by mouth daily on days 1-4; Includes 32 participants who received at least one dose of pravastatin 40 mg during days 1-4.
10914293|NCT00630734|EG001|Reported Event|Darunavir/Ritonavir Alone|Darunavir/Ritonavir 600/100 mg by mouth twice daily on days 12-14; Includes 31 participants who received at least one dose of darunavir/ritonavir during days 12-14.
10914294|NCT00630734|EG002|Reported Event|Pravastatin + Darunavir/Ritonavir|Darunavir/ritonavir 600/100 mg by mouth twice daily and pravastatin 40 mg by mouth once daily on days 15-18. Includes 28 participants who received at least one dose of darunavir/ritonavir and pravastatin during days 15-18.
10914295|NCT00630747|BG000|Baseline|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
10914296|NCT00630747|FG000|Participant Flow|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered by intravenous (IV) infusion once-weekly.
10914297|NCT00630747|OG000|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
10914298|NCT00630747|EG000|Reported Event|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
10914299|NCT00630786|BG000|Baseline|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
10914300|NCT00630786|BG001|Baseline|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
10914301|NCT00630786|BG002|Baseline|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
10914302|NCT00630786|BG003|Baseline|Total|Total of all reporting groups
10914303|NCT00630786|FG000|Participant Flow|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
10914304|NCT00630786|FG001|Participant Flow|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
11233673|NCT02430337|OG000|Outcome|Technology-Assisted SafeCare|"A modified version of SafeCare, using a tablet and online program to complete a portion of the session~Technology-Assisted SafeCare: A technology-enhanced version of SafeCare"
10914305|NCT00630786|FG002|Participant Flow|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
10914306|NCT00630786|OG000|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
10914307|NCT00630786|OG000|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
10914308|NCT00630786|OG001|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
10914309|NCT00630786|EG000|Reported Event|Panitumumab + AMG 655|
10914310|NCT00630812|BG000|Baseline|Mannitol 400mg|"active treatment~inhaled mannitol: 400 mg BD for 26 + 26 weeks"
10914311|NCT00630812|BG001|Baseline|Control|Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
10914312|NCT00630812|BG002|Baseline|Total|Total of all reporting groups
10914313|NCT00630812|FG000|Participant Flow|Mannitol 400mg|"active treatment~inhaled mannitol: 400 mg twice a day (BD) for 26 + 26 weeks"
10914314|NCT00630812|FG001|Participant Flow|Control|Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
10914315|NCT00630812|OG000|Outcome|Mannitol 400mg|"active treatment~inhaled mannitol: 400 mg BD for 26 + 26 weeks"
10914316|NCT00630812|OG001|Outcome|Control|Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
10914317|NCT00630812|EG000|Reported Event|Mannitol 400mg|"active treatment~inhaled mannitol: 400 mg BD for 26 + 26 weeks"
10914318|NCT00630812|EG001|Reported Event|Control|Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
10914319|NCT00630825|BG000|Baseline|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
10914320|NCT00630825|BG001|Baseline|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
10914321|NCT00630825|BG002|Baseline|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
10914322|NCT00630825|BG003|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
10914323|NCT00630825|BG004|Baseline|Total|Total of all reporting groups
10914324|NCT00630825|FG000|Participant Flow|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
10914325|NCT00630825|FG001|Participant Flow|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
10914326|NCT00630825|FG002|Participant Flow|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
10914327|NCT00630825|FG003|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
10914328|NCT00630825|OG000|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
10914329|NCT00630825|OG001|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
10914330|NCT00630825|OG002|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
10914331|NCT00630825|OG003|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
10914332|NCT00630825|EG000|Reported Event|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
10914333|NCT00630825|EG001|Reported Event|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
10914334|NCT00630825|EG002|Reported Event|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
10914335|NCT00630825|EG003|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
10914336|NCT00630838|BG000|Baseline|VSL#3 Probiotic|"VSL#3 probiotic~VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
10914337|NCT00630838|BG001|Baseline|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
10914338|NCT00630838|BG002|Baseline|Total|Total of all reporting groups
10914339|NCT00630838|FG000|Participant Flow|VSL#3 Probiotic|"VSL#3 probiotic~VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
11233674|NCT02430337|OG001|Outcome|SafeCare-as-usual|"SafeCare as it is usually delivered~SafeCare: SafeCare, an evidence-based home visiting program"
10914340|NCT00630838|FG001|Participant Flow|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
10914341|NCT00630838|OG000|Outcome|VSL#3 Probiotic|"VSL#3: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
10914342|NCT00630838|OG001|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
10914343|NCT00630838|OG000|Outcome|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
10914344|NCT00630838|OG001|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
10914345|NCT00630838|EG000|Reported Event|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
10915164|NCT00634244|FG002|Participant Flow|Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)|"Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV~sirolimus: Given PO~etoposide: Given IV"
10915165|NCT00634244|OG000|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
11233675|NCT02430337|OG000|Outcome|SafeCare-as-usual|"SafeCare as it is usually delivered~SafeCare: SafeCare, an evidence-based home visiting program"
11173467|NCT02015754|BG000|Baseline|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
10914346|NCT00630838|EG001|Reported Event|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
10914347|NCT00630864|BG000|Baseline|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator's discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
10914348|NCT00630864|FG000|Participant Flow|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator's discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
10914349|NCT00630864|OG000|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator's discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
10914350|NCT00630864|EG000|Reported Event|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator's discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
10914351|NCT00630877|BG000|Baseline|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
10914352|NCT00630877|BG001|Baseline|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
10914353|NCT00630877|BG002|Baseline|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
10914354|NCT00630877|BG003|Baseline|Total|Total of all reporting groups
10914355|NCT00630877|FG000|Participant Flow|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
10914356|NCT00630877|FG001|Participant Flow|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
10914357|NCT00630877|FG002|Participant Flow|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
10914358|NCT00630877|OG000|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
10914359|NCT00630877|OG000|Outcome|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
10914360|NCT00630877|OG001|Outcome|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
10914361|NCT00630877|OG002|Outcome|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
10914362|NCT00630877|OG000|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
10914363|NCT00630877|OG000|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
10914364|NCT00630877|OG001|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
10914365|NCT00630877|EG000|Reported Event|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
10914366|NCT00630877|EG001|Reported Event|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
10914367|NCT00630877|EG002|Reported Event|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
10914368|NCT00630916|BG000|Baseline|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
10914369|NCT00630916|FG000|Participant Flow|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
10914370|NCT00630916|OG000|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
10914371|NCT00630916|EG000|Reported Event|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
10914372|NCT00630955|BG000|Baseline|0 mg Memantine|
10914373|NCT00630955|BG001|Baseline|20 mg Memantine|
10914374|NCT00630955|BG002|Baseline|40 mg Memantine|
10914375|NCT00630955|BG003|Baseline|Total|Total of all reporting groups
10914376|NCT00630955|FG000|Participant Flow|0 mg Memantine|Participants who received placebo PO qd
11173468|NCT02015754|FG000|Participant Flow|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
10914377|NCT00630955|FG001|Participant Flow|20 mg Memantine|Participants randomized to 20 mg memantine PO qd
10914378|NCT00630955|FG002|Participant Flow|40 mg Memantine|Participants randomized to 40mg memantine PO qd
10914379|NCT00630955|OG000|Outcome|0 mg Memantine|Participants who received placebo
10914380|NCT00630955|OG001|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
10914381|NCT00630955|OG002|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
10914382|NCT00630955|EG000|Reported Event|0 mg|Participants who received placebo
10914383|NCT00630955|EG001|Reported Event|20 mg|Participants randomized to 20 mg memantine
10914384|NCT00630955|EG002|Reported Event|40 mg|Participants randomized to 40mg memantine
10914385|NCT00630994|BG000|Baseline|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
10914386|NCT00630994|FG000|Participant Flow|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
10914387|NCT00630994|OG000|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
10914388|NCT00630994|EG000|Reported Event|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
11233676|NCT02430337|OG001|Outcome|Technology-Assisted SafeCare|"A modified version of SafeCare, using a tablet and online program to complete a portion of the session~Technology-Assisted SafeCare: A technology-enhanced version of SafeCare"
11233677|NCT02430337|EG000|Reported Event|SafeCare-as-usual|"SafeCare as it is usually delivered~SafeCare: SafeCare, an evidence-based home visiting program"
10914389|NCT00631007|BG000|Baseline|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
10914390|NCT00631007|BG001|Baseline|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
10914391|NCT00631007|BG002|Baseline|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
10914392|NCT00631007|BG003|Baseline|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
10914393|NCT00631007|BG004|Baseline|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
10914394|NCT00631007|BG005|Baseline|Placebo|placebo administered once-daily
10914395|NCT00631007|BG006|Baseline|Total|Total of all reporting groups
10914396|NCT00631007|FG000|Participant Flow|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
10914397|NCT00631007|FG001|Participant Flow|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
10914398|NCT00631007|FG002|Participant Flow|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
10914399|NCT00631007|FG003|Participant Flow|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
10914400|NCT00631007|FG004|Participant Flow|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
10914401|NCT00631007|FG005|Participant Flow|Placebo|placebo administered once-daily
10914402|NCT00631007|OG000|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
10914403|NCT00631007|OG001|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
10914404|NCT00631007|OG002|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
10914405|NCT00631007|OG003|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
10914406|NCT00631007|OG004|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
10914407|NCT00631007|OG005|Outcome|Placebo|placebo administered once-daily
10914408|NCT00631007|EG000|Reported Event|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
10914409|NCT00631007|EG001|Reported Event|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
10914410|NCT00631007|EG002|Reported Event|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
10914411|NCT00631007|EG003|Reported Event|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
10914412|NCT00631007|EG004|Reported Event|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
10914413|NCT00631007|EG005|Reported Event|Placebo|placebo administered once-daily
10914414|NCT00631020|BG000|Baseline|CBME +/- NRT|6 weeks of once a week CBME with optional 4 weeks NRT
10914415|NCT00631020|FG000|Participant Flow|CBME +/- NRT|6 weeks CBME with optional NRT for 4 weeks
10914416|NCT00631020|OG000|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
10914417|NCT00631020|EG000|Reported Event|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
10914418|NCT00631163|BG000|Baseline|Deferasirox|Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
10914419|NCT00631163|FG000|Participant Flow|Deferasirox|Participants received initial dose of 20 milligrams per kilogram (mg/kg) Deferasirox tablets was administered orally once daily (OD) based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
10914420|NCT00631163|OG000|Outcome|Deferasirox|Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
10914421|NCT00631163|OG000|Outcome|All Randomized Participants|Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
11335517|NCT03552198|BG002|Baseline|At Risk Group/Usual Health Advice|Participants with a self-reported pre-existing health condition were randomised to receive the usual UK Air Quality Indices health advice.
10914422|NCT00631163|OG001|Outcome|Japanese Participants|Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
10914423|NCT00631163|OG000|Outcome|Deferasirox (Extension Study)|Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
10914424|NCT00631163|OG000|Outcome|Deferasirox (Core Study)|Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
10914425|NCT00631163|OG001|Outcome|Deferasirox (Extension Study)|Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
10914426|NCT00631163|EG000|Reported Event|Myelodysplastic Syndrome|A group of disorders caused when something disrupts the production of blood cells.
10914427|NCT00631163|EG001|Reported Event|Aplastic Anemia|Aplastic anemia is a condition that occurs when your body stops producing enough new blood cells. The condition leaves you fatigued and more prone to infections and uncontrolled bleeding.
10914428|NCT00631163|EG002|Reported Event|Other|Very rare diseases (e.g. Diamond Blackfan anemia, myelofibrosis, specific enzyme deficiency).
10914429|NCT00631189|BG000|Baseline|Initial Phase|Initial phase (between V1 and V2)
10914430|NCT00631189|BG001|Baseline|Atorvastatin|Atorvastatin 10 mg
10914431|NCT00631189|BG002|Baseline|Pravastatin|Pravastatin 40 mg
10914432|NCT00631189|BG003|Baseline|Rosuvastatin|Rosuvastatin 5 mg
10914433|NCT00631189|BG004|Baseline|Total|Total of all reporting groups
10914434|NCT00631189|FG000|Participant Flow|Initial Phase|Initial phase (between V1 and V2)
10914435|NCT00631189|FG001|Participant Flow|Atorvastatin|Atorvastatin 10 mg
10914436|NCT00631189|FG002|Participant Flow|Pravastatin|Pravastatin 40 mg
10914437|NCT00631189|FG003|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg
10914438|NCT00631189|OG000|Outcome|Initial Phase|Initial phase (between V1 and V2)
10914439|NCT00631189|OG001|Outcome|Atorvastatin|Atorvastatin 10 mg
10914440|NCT00631189|OG002|Outcome|Pravastatin|Pravastatin 40 mg
11233678|NCT02430337|EG001|Reported Event|Technology-Assisted SafeCare|"A modified version of SafeCare, using a tablet and online program to complete a portion of the session~Technology-Assisted SafeCare: A technology-enhanced version of SafeCare"
10914441|NCT00631189|OG003|Outcome|Rosuvastatin|Rosuvastatin 5 mg
10914442|NCT00631189|EG000|Reported Event|Initial Phase|Initial phase (between V1 and V2)
10914443|NCT00631189|EG001|Reported Event|Atorvastatin|Atorvastatin 10 mg
10914444|NCT00631189|EG002|Reported Event|Pravastatin|Pravastatin 40 mg
10914445|NCT00631189|EG003|Reported Event|Rosuvastatin|Rosuvastatin 5 mg
10914446|NCT00631319|BG000|Baseline|OROS Hydromorphone|OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
10914447|NCT00631319|BG001|Baseline|Placebo|Matching placebo tablets orally once daily
10914448|NCT00631319|BG002|Baseline|Total|Total of all reporting groups
10914449|NCT00631319|FG000|Participant Flow|OROS Hydromorphone|OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
10914450|NCT00631319|FG001|Participant Flow|Placebo|Matching placebo tablets orally once daily
10914451|NCT00631319|OG000|Outcome|OROS Hydromorphone|OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64
10914452|NCT00631319|OG001|Outcome|Placebo|Matching placebo tablets orally once daily
10914453|NCT00631319|EG000|Reported Event|Conversion and Titration Phase|OROS hydromorphone 12, 16, 24, 32, 40, 48 or 64 mg
10914454|NCT00631319|EG001|Reported Event|Double-blind Phase - Hydromorphone|OROS hydromorphone 12, 16, 24, 32, 40, 48 or 64 mg
10914455|NCT00631319|EG002|Reported Event|Double-blind Phase - Placebo|Matching placebo tablets orally once daily
10914456|NCT00631358|BG000|Baseline|Maxidex|Maxidex 1 drop in each eye 2 times daily
10914457|NCT00631358|BG001|Baseline|No Treatment|Healthy normal control group receiving no treatment
10914458|NCT00631358|BG002|Baseline|Total|Total of all reporting groups
10914459|NCT00631358|FG000|Participant Flow|Maxidex|Maxidex 1 drop in each eye 2 times daily
10914460|NCT00631358|FG001|Participant Flow|No Treatment|Healthy normal control group receiving no treatment
10914461|NCT00631358|OG000|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
10914462|NCT00631358|OG001|Outcome|No Treatment|Healthy normal control group receiving no treatment
10914463|NCT00631358|EG000|Reported Event|Maxidex|Maxidex 1 drop in each eye 2 times daily
10914464|NCT00631358|EG001|Reported Event|No Treatment|Healthy normal control group receiving no treatment
10914465|NCT00631371|BG000|Baseline|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
10914466|NCT00631371|BG001|Baseline|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
10914467|NCT00631371|BG002|Baseline|Total|Total of all reporting groups
10914468|NCT00631371|FG000|Participant Flow|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
10914469|NCT00631371|FG001|Participant Flow|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
10914470|NCT00631371|OG000|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
10914471|NCT00631371|OG001|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
10914472|NCT00631371|EG000|Reported Event|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
10914473|NCT00631371|EG001|Reported Event|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
10914474|NCT00631410|BG000|Baseline|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
10914475|NCT00631410|BG001|Baseline|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
10914476|NCT00631410|BG002|Baseline|Total|Total of all reporting groups
10914477|NCT00631410|FG000|Participant Flow|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
10914478|NCT00631410|FG001|Participant Flow|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
10914479|NCT00631410|OG000|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
10914480|NCT00631410|OG001|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
10914481|NCT00631410|OG000|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
10914482|NCT00631410|OG000|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
11091759|NCT01536145|OG008|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
10914483|NCT00631410|OG000|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
10914484|NCT00631410|EG000|Reported Event|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
10914485|NCT00631410|EG001|Reported Event|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
10914486|NCT00631449|BG000|Baseline|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
10914487|NCT00631449|BG001|Baseline|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
10914488|NCT00631449|BG002|Baseline|Total|Total of all reporting groups
10914489|NCT00631449|FG000|Participant Flow|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
10914490|NCT00631449|FG001|Participant Flow|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
10914491|NCT00631449|OG000|Outcome|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
10914492|NCT00631449|OG001|Outcome|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
10914493|NCT00631449|OG000|Outcome|Raltegravir|"For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.~Raltegravir: For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines."
10914494|NCT00631449|OG001|Outcome|Placebo|"For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.~Placebo: For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines."
10914495|NCT00631449|EG000|Reported Event|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
10914496|NCT00631449|EG001|Reported Event|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
10914497|NCT00631475|BG000|Baseline|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
10914498|NCT00631475|FG000|Participant Flow|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
10914499|NCT00631475|OG000|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
10914500|NCT00631475|EG000|Reported Event|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
10914501|NCT00631488|BG000|Baseline|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
10914502|NCT00631488|BG001|Baseline|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
11173469|NCT02015754|OG000|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
11335655|NCT03554629|OG000|Outcome|EtCO2 During Mouth Closed Breathing Rate of 6|Patient interface to sample gas for EtCO2 capnography measurement under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm.
10914503|NCT00631488|BG002|Baseline|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
10914504|NCT00631488|BG003|Baseline|Total|Total of all reporting groups
10914505|NCT00631488|FG000|Participant Flow|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
10914506|NCT00631488|FG001|Participant Flow|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
10914507|NCT00631488|FG002|Participant Flow|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
10914508|NCT00631488|OG000|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
10914509|NCT00631488|OG001|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
11233679|NCT02430389|BG000|Baseline|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
11233680|NCT02430389|BG001|Baseline|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
10914510|NCT00631488|OG002|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
10914511|NCT00631488|EG000|Reported Event|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
10914512|NCT00631488|EG001|Reported Event|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
10914513|NCT00631488|EG002|Reported Event|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
10914514|NCT00631540|BG000|Baseline|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
10914515|NCT00631540|FG000|Participant Flow|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
10914516|NCT00631540|OG000|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
10914517|NCT00631540|EG000|Reported Event|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
10914518|NCT00631566|BG000|Baseline|Mupirocin/Hexachlorophene Group|"Participants with MRSA colonization who were randomized to receive:~Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%: BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).~pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.~Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days."
10914519|NCT00631566|BG001|Baseline|Placebo Group|"Participants with MRSA colonization who were randomized to receive:~Placebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days."
10914520|NCT00631566|BG002|Baseline|No MRSA Colonization|Patients who did not have any MRSA colonization.
10914521|NCT00631566|BG003|Baseline|Total|Total of all reporting groups
11233681|NCT02430389|BG002|Baseline|Total|Total of all reporting groups
10914522|NCT00631566|FG000|Participant Flow|Mupirocin/Hexachlorophene Group|"Participants with MRSA colonization who were randomized to receive:~Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%: BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).~pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.~Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days."
10914523|NCT00631566|FG001|Participant Flow|Placebo Group|"Participants with MRSA colonization who were randomized to receive:~Placebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days."
10914524|NCT00631566|FG002|Participant Flow|No MRSA Colonization|Patients who did not have any MRSA colonization.
10914525|NCT00631566|OG000|Outcome|Mupirocin/Hexachlorophene Group|"Participants with MRSA colonization who were randomized to receive:~Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%: BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).~pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.~Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days."
10914526|NCT00631566|OG001|Outcome|Placebo Group|"Participants with MRSA colonization who were randomized to receive:~Placebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days."
10914527|NCT00631566|OG002|Outcome|No MRSA Colonization|Patients who did not have any MRSA colonization.
10914528|NCT00631566|EG000|Reported Event|Mupirocin/Hexachlorophene Group|"Participants with MRSA colonization who were randomized to receive:~Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%: BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).~pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.~Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days."
11173470|NCT02015754|EG000|Reported Event|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
11173471|NCT02015793|BG000|Baseline|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
11173472|NCT02015793|BG001|Baseline|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
11173473|NCT02015793|BG002|Baseline|Total|Total of all reporting groups
11173474|NCT02015793|FG000|Participant Flow|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
11173475|NCT02015793|FG001|Participant Flow|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
11173476|NCT02015793|OG000|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
11173477|NCT02015793|OG001|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
11173478|NCT02015793|OG000|Outcome|Low Induction Dose (Double-blind Period)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
11173479|NCT02015793|OG001|Outcome|Standard Induction Dose (Double-blind Period)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
11173480|NCT02015793|OG002|Outcome|Low Induction Dose (Open-label Extension Period)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
11173481|NCT02015793|OG003|Outcome|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
10914529|NCT00631566|EG001|Reported Event|Placebo Group|"Participants with MRSA colonization who were randomized to receive:~Placebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days."
10914530|NCT00631566|EG002|Reported Event|No MRSA Colonization|Patients who did not have any MRSA colonization.
10914531|NCT00631657|BG000|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
10914532|NCT00631657|BG001|Baseline|Placebo|Participants receive placebo tablets, administered QD for 6 months
11173482|NCT02015793|EG000|Reported Event|Low Induction Dose (Double-blind)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
11173483|NCT02015793|EG001|Reported Event|Standard Induction Dose (Double-blind)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
11173484|NCT02015793|EG002|Reported Event|Low Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
10914533|NCT00631657|BG002|Baseline|Total|Total of all reporting groups
10914534|NCT00631657|FG000|Participant Flow|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered once a day (QD) for 6 months, then participants receive esmirtazapine 4.5 mg tablets, administered QD for 7 days
10914535|NCT00631657|FG001|Participant Flow|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
10914536|NCT00631657|FG002|Participant Flow|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
10914537|NCT00631657|OG000|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
10914538|NCT00631657|OG001|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
10914539|NCT00631657|OG001|Outcome|Placebo|Participants receive placebo tablets, administered QD
10914540|NCT00631657|OG001|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months.
10914541|NCT00631657|OG000|Outcome|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by esmirtazapine 4.5 mg tablets, administered QD for 7 days during the Discontinuation Period
10914542|NCT00631657|OG001|Outcome|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
10914543|NCT00631657|OG002|Outcome|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
10914544|NCT00631657|EG000|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD
10914545|NCT00631657|EG001|Reported Event|Placebo|Participants receive placebo tablets, administered QD
10914546|NCT00631670|BG000|Baseline|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
10914547|NCT00631670|BG001|Baseline|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
10914548|NCT00631670|BG002|Baseline|Total|Total of all reporting groups
10914549|NCT00631670|FG000|Participant Flow|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
10914550|NCT00631670|FG001|Participant Flow|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
10914551|NCT00631670|OG000|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
11173485|NCT02015793|EG003|Reported Event|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
11173486|NCT02015819|BG000|Baseline|Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg)|Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10914552|NCT00631670|OG001|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
10914553|NCT00631670|OG000|Outcome|Single Treatment Group|15 Gy dose in one treatment
10914554|NCT00631670|OG001|Outcome|25 Treatments Grouop|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
10914555|NCT00631670|OG000|Outcome|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
10914556|NCT00631670|OG001|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
10914557|NCT00631670|EG000|Reported Event|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
10914558|NCT00631670|EG001|Reported Event|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
10914559|NCT00631696|BG000|Baseline|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
10914560|NCT00631696|BG001|Baseline|Placebo|Placebo matching pregabalin treatment.
10914561|NCT00631696|BG002|Baseline|Total|Total of all reporting groups
10914562|NCT00631696|FG000|Participant Flow|Pregabalin|Pregabalin 50 milligrams (mg) by mouth (PO) twice a day (BID) starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
10914563|NCT00631696|FG001|Participant Flow|Placebo|Placebo matching pregabalin treatment.
10914564|NCT00631696|OG000|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
10914565|NCT00631696|OG001|Outcome|Placebo|Placebo matching pregabalin treatment.
10914566|NCT00631696|EG000|Reported Event|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
10914567|NCT00631696|EG001|Reported Event|Placebo|Placebo matching pregabalin treatment.
10914568|NCT00631748|BG000|Baseline|Study Drug|Oral quetiapine
10914569|NCT00631748|BG001|Baseline|Placebo|Placebo (sugar pill)
10914570|NCT00631748|BG002|Baseline|Total|Total of all reporting groups
10914571|NCT00631748|FG000|Participant Flow|Study Drug|Oral quetiapine
10914572|NCT00631748|FG001|Participant Flow|Placebo|Placebo (sugar pill)
10914573|NCT00631748|OG000|Outcome|Study Drug|Quetiapine (Seroquel XR)
10914574|NCT00631748|OG001|Outcome|Placebo|matched placebo (sugar pill)
10914575|NCT00631748|OG001|Outcome|Placebo|match placebo (sugar pill)
10914576|NCT00631748|EG000|Reported Event|Study Drug|Oral quetiapine
10914577|NCT00631748|EG001|Reported Event|Placebo|Placebo (sugar pill)
10915166|NCT00634244|OG001|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
10915167|NCT00634244|OG002|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
10915168|NCT00634244|EG000|Reported Event|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
10915169|NCT00634244|EG001|Reported Event|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
10915170|NCT00634244|EG002|Reported Event|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
10915171|NCT00634270|BG000|Baseline|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
10915172|NCT00634270|BG001|Baseline|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
10915173|NCT00634270|BG002|Baseline|Total|Total of all reporting groups
10915174|NCT00634270|FG000|Participant Flow|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
10915175|NCT00634270|FG001|Participant Flow|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
10915176|NCT00634270|OG000|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
10915177|NCT00634270|OG001|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
10915178|NCT00634270|OG000|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
10915179|NCT00634270|OG000|Outcome|Stratum 1|Patients ≥ 3 years old with progressive plexiform neurofibroma(s) with the potential to cause significant morbidity.
10915180|NCT00634270|OG001|Outcome|Stratum 2|Patients ≥ 3 years old and plexiform neurofibroma(s) without documented radiographic progression at trial entry. The endpoint will be radiographic response.
11357465|NCT03757234|OG002|Outcome|Omadacycline 200 iv/300 po or 100 iv|On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
10915181|NCT00634270|OG000|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing."
10915182|NCT00634270|OG000|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
11091760|NCT01536145|OG000|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091761|NCT01536145|OG001|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091762|NCT01536145|OG002|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
11091763|NCT01536145|OG003|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10914578|NCT00631852|BG000|Baseline|American Ginseng Root|"four, 250mg tablets daily 5-14 days prior to surgery~American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery"
10914579|NCT00631852|FG000|Participant Flow|American Ginseng Root|"four, 250mg tablets daily 5-14 days prior to surgery~American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery"
10914580|NCT00631852|OG000|Outcome|American Ginseng Root|"four, 250mg tablets daily 5-14 days prior to surgery~American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery"
10914581|NCT00631852|EG000|Reported Event|American Ginseng Root|"four, 250mg tablets daily 5-14 days prior to surgery~American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery"
10914582|NCT00631917|BG000|Baseline|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
10914583|NCT00631917|BG001|Baseline|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
10914584|NCT00631917|BG002|Baseline|Total|Total of all reporting groups
10914585|NCT00631917|FG000|Participant Flow|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
10914586|NCT00631917|FG001|Participant Flow|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
10914587|NCT00631917|OG000|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
10914588|NCT00631917|OG001|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
10914589|NCT00631917|EG000|Reported Event|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
10914590|NCT00631917|EG001|Reported Event|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
10914591|NCT00631969|BG000|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10914592|NCT00631969|BG001|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10914593|NCT00631969|BG002|Baseline|Total|Total of all reporting groups
11091764|NCT01536145|OG004|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
10914594|NCT00631969|FG000|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10914595|NCT00631969|FG001|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10914596|NCT00631969|OG000|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10914597|NCT00631969|OG001|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10914598|NCT00631969|OG000|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
10914599|NCT00631969|OG001|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
10914600|NCT00631969|EG000|Reported Event|Vardenafil ODT (STAXYN, BAY 38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10914601|NCT00631969|EG001|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10914602|NCT00632021|BG000|Baseline|Control (Usual Care)|Control (usual care) arm
10914603|NCT00632021|BG001|Baseline|Intervention|Intervention arm
10914604|NCT00632021|BG002|Baseline|Total|Total of all reporting groups
10914605|NCT00632021|FG000|Participant Flow|Control (Usual Care)|Control (usual care) arm
10914606|NCT00632021|FG001|Participant Flow|Intervention|Intervention arm
10914607|NCT00632021|OG000|Outcome|Control|Control (usual care) arm
10914608|NCT00632021|OG001|Outcome|Intervention|Intervention arm
10914609|NCT00632021|OG000|Outcome|Control (Usual Care)|Control (usual care) arm
10914610|NCT00632021|EG000|Reported Event|Control (Usual Care)|Control (usual care) arm
10914611|NCT00632021|EG001|Reported Event|Intervention|Intervention arm
10914612|NCT00632099|BG000|Baseline|Matched Placebo|"matched placebo~Placebo: matched placebo"
10914613|NCT00632099|BG001|Baseline|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
11091765|NCT01536145|OG005|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
10914614|NCT00632099|BG002|Baseline|Total|Total of all reporting groups
10914615|NCT00632099|FG000|Participant Flow|Matched Placebo|"matched placebo~Placebo: matched placebo"
10914616|NCT00632099|FG001|Participant Flow|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
10914617|NCT00632099|OG000|Outcome|Matched Placebo|"matched placebo~Placebo: matched placebo"
10914618|NCT00632099|OG001|Outcome|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
10914619|NCT00632099|EG000|Reported Event|Matched Placebo|"matched placebo~Placebo: matched placebo"
10914620|NCT00632099|EG001|Reported Event|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
10914621|NCT00632125|BG000|Baseline|HX575|HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the SmPC
10914622|NCT00632125|FG000|Participant Flow|HX575|HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the summary of product characteristics (SmPC)
10914623|NCT00632125|OG000|Outcome|HX575|HX575 administered i.v. according to the SmPC
10914624|NCT00632125|EG000|Reported Event|HX575|HX575 administered i.v. according to the SmPC
10914625|NCT00632203|BG000|Baseline|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
10914626|NCT00632203|BG001|Baseline|Observation|Observation
10914627|NCT00632203|BG002|Baseline|Total|Total of all reporting groups
10914628|NCT00632203|FG000|Participant Flow|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
10914629|NCT00632203|FG001|Participant Flow|Observation|Observation
10914630|NCT00632203|OG000|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
10914631|NCT00632203|OG001|Outcome|Observation|Observation
10914632|NCT00632203|EG000|Reported Event|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
10914633|NCT00632203|EG001|Reported Event|Observation|Observation
10914634|NCT00632229|BG000|Baseline|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
10914635|NCT00632229|BG001|Baseline|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
10914636|NCT00632229|BG002|Baseline|Total|Total of all reporting groups
10914637|NCT00632229|FG000|Participant Flow|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
10914638|NCT00632229|FG001|Participant Flow|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
10914639|NCT00632229|OG000|Outcome|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
10914640|NCT00632229|OG001|Outcome|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
10914641|NCT00632229|EG000|Reported Event|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
10914642|NCT00632229|EG001|Reported Event|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
10914643|NCT00632281|BG000|Baseline|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
10914644|NCT00632281|FG000|Participant Flow|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
10914645|NCT00632281|OG000|Outcome|All Patients Receiving SBRT to the Thorax|
10914646|NCT00632281|EG000|Reported Event|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
10914647|NCT00632359|BG000|Baseline|Lenalidomide|Lenalidomide 10 mg daily given for 12 months.
10914648|NCT00632359|FG000|Participant Flow|Lenalidomide|Lenalidomide 10 mg daily given for 12 months.
10914649|NCT00632359|OG000|Outcome|Lenalidomide|Lenalidomide 10 mg daily given for 12 months.
10914650|NCT00632359|OG000|Outcome|Assessment at End of Consolidation|Response following 12 months of Lenalidomide 10 mg daily.
10914651|NCT00632359|EG000|Reported Event|Lenalidomide|Lenalidomide 10 mg daily given for 12 months.
10914652|NCT00632411|BG000|Baseline|Proactive Group|"Research study staff will contact participant to initiate sessions.~8 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.~Six sessions will be proactively delivered to the participant.~Phone session 1 will focus on smoking reduction.~Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.~Phone session 3 will focus on the first days after the quit date.~Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.~Phone session 5 will focus on short-term relapse prevention.~Phone session 6 will focus on long-term relapse prevention."
11091766|NCT01536145|OG006|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
10914653|NCT00632411|BG001|Baseline|Reactive Group|"Participant will contact the research study staff to initiate sessions.~2 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.~Six sessions will be delivered to the participant as long as the participant calls to initiate the sessions.~Phone session 1 will focus on smoking reduction.~Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.~Phone session 3 will focus on the first days after the quit date.~Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.~Phone session 5 will focus on short-term relapse prevention.~Phone session 6 will focus on long-term relapse prevention."
10914654|NCT00632411|BG002|Baseline|Total|Total of all reporting groups
10914655|NCT00632411|FG000|Participant Flow|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
10914656|NCT00632411|FG001|Participant Flow|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
10914657|NCT00632411|OG000|Outcome|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
10914658|NCT00632411|OG001|Outcome|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
10914659|NCT00632411|EG000|Reported Event|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
10914660|NCT00632411|EG001|Reported Event|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
10914661|NCT00632424|BG000|Baseline|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
10914662|NCT00632424|BG001|Baseline|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
10914663|NCT00632424|BG002|Baseline|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
10914664|NCT00632424|BG003|Baseline|Total|Total of all reporting groups
10914665|NCT00632424|FG000|Participant Flow|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle.
10914666|NCT00632424|OG000|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
10914667|NCT00632424|OG001|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
10914668|NCT00632424|OG002|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
10914669|NCT00632424|OG000|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
10914670|NCT00632424|OG000|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
10914671|NCT00632424|OG001|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
10914672|NCT00632424|OG002|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
10914673|NCT00632424|OG001|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
10914674|NCT00632424|OG002|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
10914675|NCT00632424|EG000|Reported Event|Ixa 90 mg/Day|
11233682|NCT02430389|FG000|Participant Flow|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
10914676|NCT00632424|EG001|Reported Event|Ixa 120 mg/Day|
10914677|NCT00632424|EG002|Reported Event|Ixa 150 mg/Day|
11233683|NCT02430389|FG001|Participant Flow|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
10914678|NCT00632463|BG000|Baseline|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
10914679|NCT00632463|BG001|Baseline|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
10914680|NCT00632463|BG002|Baseline|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
11174326|NCT02020941|EG000|Reported Event|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
11174327|NCT02020967|BG000|Baseline|Acromegaly Diagnosed|Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.
11174328|NCT02020967|BG001|Baseline|No Acromegaly Diagnosed|Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
11174329|NCT02020967|BG002|Baseline|Total|Total of all reporting groups
11174330|NCT02020967|FG000|Participant Flow|All Participants|"Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages:~Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays.~Stage of examination: Insulin-like growth factor 1 (IGF-1) level was measured. In case of increased IGF-1 level, growth hormone (GH) test before and after oral glucose tolerance test (OGTT) was conducted. If acromegaly was confirmed, pituitary magnetic resonance imaging (MRI) with contrast was made."
11174331|NCT02020967|OG000|Outcome|All Participants|"Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages:~Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays.~Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made."
11174332|NCT02020967|OG000|Outcome|Acromegaly Diagnosed|Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.
11174333|NCT02020967|OG001|Outcome|No Acromegaly Diagnosed|Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
11174334|NCT02020967|EG000|Reported Event|All Participants|Participants did not receive any investigational therapy or special examination methods. Participants were involved in the survey focused on early acromegaly diagnosis.
11174335|NCT02021292|BG000|Baseline|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
11174336|NCT02021292|BG001|Baseline|Placebo|Matching placebo oral tablet, to be taken once daily.
11174337|NCT02021292|BG002|Baseline|Total|Total of all reporting groups
11174338|NCT02021292|FG000|Participant Flow|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
11174339|NCT02021292|FG001|Participant Flow|Placebo|Matching placebo oral tablet, to be taken once daily.
11174340|NCT02021292|OG000|Outcome|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily
11174341|NCT02021292|OG001|Outcome|Placebo|Matching placebo oral tablet, to be taken once daily
11174342|NCT02021292|OG000|Outcome|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
11174343|NCT02021292|OG001|Outcome|Placebo|Matching placebo oral tablet, to be taken once daily.
11174344|NCT02021292|EG000|Reported Event|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
11174345|NCT02021292|EG001|Reported Event|Placebo|Matching placebo oral tablet, to be taken once daily.
11174346|NCT02021318|BG000|Baseline|Roxadustat|Participants received roxadustat orally according to the tiered weight-based approach, with starting dose of 70 mg given TIW to participants weighing between 45 kg up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg up to 160 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for up to a maximum of 104 weeks.
11174347|NCT02021318|BG001|Baseline|Darbepoetin Alfa|Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 μg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 μg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks.
11174348|NCT02021318|BG002|Baseline|Total|Total of all reporting groups
11174349|NCT02021318|FG000|Participant Flow|Roxadustat|Participants received roxadustat orally according to the tiered weight-based approach, with starting dose of 70 milligram (mg) given three times weekly (TIW) to participants weighing between 45 kilogram (kg) up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg up to 160 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for up to a maximum of 104 weeks.
10915222|NCT00634751|BG000|Baseline|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
10915223|NCT00634751|BG001|Baseline|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
10915224|NCT00634751|BG002|Baseline|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
10915225|NCT00634751|BG003|Baseline|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
10915226|NCT00634751|BG004|Baseline|Total|Total of all reporting groups
10915227|NCT00634751|FG000|Participant Flow|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
10915228|NCT00634751|FG001|Participant Flow|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
11174350|NCT02021318|FG001|Participant Flow|Darbepoetin Alfa|Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 microgram per kilogram [μg/kg] of body weight, as a single subcutaneous or intravenous [IV] injection once weekly or 0.75 μg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per European Summary of Product Characteristics (EU SmPC) along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 grams per deciliter (g/dL) and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks.
10915229|NCT00634751|FG002|Participant Flow|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
11191296|NCT02131636|BG000|Baseline|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
11191297|NCT02131636|BG001|Baseline|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
11174351|NCT02021318|OG000|Outcome|Roxadustat|Participants received roxadustat orally according to the tiered weight-based approach, with starting dose of 70 mg given TIW to participants weighing between 45 kg up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg up to 160 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for up to a maximum of 104 weeks.
11174352|NCT02021318|OG001|Outcome|Darbepoetin Alfa|Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks.
11174353|NCT02021318|OG001|Outcome|Darbepoetin Alfa|Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks.
11174354|NCT02021318|EG000|Reported Event|Roxadustat|Participants received roxadustat orally according to the tiered weight-based approach, with starting dose of 70 mg given TIW to participants weighing between 45 kg up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg up to 160 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for up to a maximum of 104 weeks.
11174355|NCT02021318|EG001|Reported Event|Darbepoetin Alfa|Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 μg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 μg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks.
11174356|NCT02021331|BG000|Baseline|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
11174357|NCT02021331|BG001|Baseline|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
11174358|NCT02021331|BG002|Baseline|Total|Total of all reporting groups
11174359|NCT02021331|FG000|Participant Flow|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
11174360|NCT02021331|FG001|Participant Flow|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
11174361|NCT02021331|OG000|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
11174362|NCT02021331|OG001|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
11174363|NCT02021331|EG000|Reported Event|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
11174364|NCT02021331|EG001|Reported Event|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
11174365|NCT02021461|BG000|Baseline|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
11174366|NCT02021461|FG000|Participant Flow|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
11191298|NCT02131636|BG002|Baseline|Total|Total of all reporting groups
11357500|NCT03756506|BG001|Baseline|Control Group: no DuraDerm|"The usual care of pin track sites will be followed as outlined below. All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.~Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.~Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris."
11357501|NCT03756506|BG002|Baseline|Total|Total of all reporting groups
11357502|NCT03756506|FG000|Participant Flow|DuraDerm® Group|"All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.~Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal."
11357503|NCT03756506|FG001|Participant Flow|Control Group: no DuraDerm|"The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.~Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.~Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris."
11357504|NCT03756506|OG000|Outcome|DuraDerm® Patient Group|"All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.~Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal."
11174367|NCT02021461|OG000|Outcome|ESL Banana Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Banana taste"
11174368|NCT02021461|OG001|Outcome|ESL Grape Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Grape taste"
11174369|NCT02021461|OG002|Outcome|ESL Tutti-Frutti Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Tutti-Frutti taste"
11174370|NCT02021461|EG000|Reported Event|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
11174371|NCT02021565|BG000|Baseline|Immediate Intervention Group|"Receives the in-home training intervention immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
11191299|NCT02131636|FG000|Participant Flow|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
11191300|NCT02131636|FG001|Participant Flow|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
11191301|NCT02131636|OG000|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
11357505|NCT03756506|OG001|Outcome|Patient Control Group: no DuraDerm|"The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.~Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.~Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris."
10915230|NCT00634751|FG003|Participant Flow|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
10915231|NCT00634751|OG000|Outcome|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
10915232|NCT00634751|OG001|Outcome|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
10915233|NCT00634751|OG002|Outcome|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
10915234|NCT00634751|OG003|Outcome|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
10915235|NCT00634751|EG000|Reported Event|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
10915236|NCT00634751|EG001|Reported Event|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
11174372|NCT02021565|BG001|Baseline|Delayed Intervention Control Group|"Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
11174373|NCT02021565|BG002|Baseline|Total|Total of all reporting groups
11191302|NCT02131636|OG001|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
11191303|NCT02131636|EG000|Reported Event|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
11191304|NCT02131636|EG001|Reported Event|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
10915237|NCT00634751|EG002|Reported Event|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
10915238|NCT00634751|EG003|Reported Event|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
10915239|NCT00634803|BG000|Baseline|CBT for POD|"Integrated cognitive behavioral therapy for chronic pain and opioid dependence~CBT: Cognitive behavioral therapy~Buprenorphine: buprenorphine/naloxone"
10915240|NCT00634803|BG001|Baseline|Educational Counseling for POD|"Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)~Buprenorphine: buprenorphine/naloxone~Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians"
10915241|NCT00634803|BG002|Baseline|Physician Management|"PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.~Buprenorphine: buprenorphine/naloxone~Physician Management: Brief physician counseling"
10915242|NCT00634803|BG003|Baseline|Total|Total of all reporting groups
10915243|NCT00634803|FG000|Participant Flow|CBT for POD|"Integrated cognitive behavioral therapy for chronic pain and opioid dependence~CBT: Cognitive behavioral therapy~Buprenorphine: buprenorphine/naloxone"
10915244|NCT00634803|FG001|Participant Flow|Educational Counseling for POD|"Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)~Buprenorphine: buprenorphine/naloxone~Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians"
10915245|NCT00634803|FG002|Participant Flow|Physician Management|"PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.~Buprenorphine: buprenorphine/naloxone~Physician Management: Brief physician counseling"
10915246|NCT00634803|OG000|Outcome|CBT for POD|"Integrated cognitive behavioral therapy for chronic pain and opioid dependence~CBT: Cognitive behavioral therapy~Buprenorphine: buprenorphine/naloxone"
10915247|NCT00634803|OG001|Outcome|Educational Counseling for POD|"Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)~Buprenorphine: buprenorphine/naloxone~Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians"
10915248|NCT00634803|OG002|Outcome|Physician Management|"PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.~Buprenorphine: buprenorphine/naloxone~Physician Management: Brief physician counseling"
10915249|NCT00634803|EG000|Reported Event|CBT for POD|"Integrated cognitive behavioral therapy for chronic pain and opioid dependence~CBT: Cognitive behavioral therapy~Buprenorphine: buprenorphine/naloxone"
10915250|NCT00634803|EG001|Reported Event|Educational Counseling for POD|"Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)~Buprenorphine: buprenorphine/naloxone~Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians"
10915251|NCT00634803|EG002|Reported Event|Physician Management|"PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.~Buprenorphine: buprenorphine/naloxone~Physician Management: Brief physician counseling"
10915252|NCT00634842|BG000|Baseline|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
10915253|NCT00634842|BG001|Baseline|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
10915254|NCT00634842|BG002|Baseline|Total|Total of all reporting groups
10915255|NCT00634842|FG000|Participant Flow|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
10915256|NCT00634842|FG001|Participant Flow|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
10915257|NCT00634842|OG000|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
10915258|NCT00634842|OG001|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
10915259|NCT00634842|EG000|Reported Event|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
10915260|NCT00634842|EG001|Reported Event|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
10915261|NCT00634907|BG000|Baseline|Genotype-Based Dosing Arm|Initial warfarin dose calculated according to published Sconce algorithm
10915262|NCT00634907|BG001|Baseline|Control Arm|Standard of care dosing
10915263|NCT00634907|BG002|Baseline|Total|Total of all reporting groups
10964025|NCT00875485|OG001|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
10964026|NCT00875485|EG000|Reported Event|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
10915264|NCT00634907|FG000|Participant Flow|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
10915265|NCT00634907|FG001|Participant Flow|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
10915266|NCT00634907|OG000|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
10915267|NCT00634907|OG001|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
10915268|NCT00634907|EG000|Reported Event|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
10915269|NCT00634907|EG001|Reported Event|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
10915270|NCT00634920|BG000|Baseline|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
10915271|NCT00634920|BG001|Baseline|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
10915272|NCT00634920|BG002|Baseline|Not Randomized Patients|This group included patients in whom a renal TX was performed but who did not qualify for randomization at Visit 2. This group was to be described with respect to treatment, reason for not randomized and outcome variables calculated or measured GFR, whichever was feasible, BPAR, graft loss or death at 12 months (no outcome variables were collected for this population
10915273|NCT00634920|BG003|Baseline|Total|Total of all reporting groups
10915274|NCT00634920|FG000|Participant Flow|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
10915275|NCT00634920|FG001|Participant Flow|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
10964027|NCT00875485|EG001|Reported Event|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
10915276|NCT00634920|FG002|Participant Flow|Pre-Randomized Patients|All patients received induction therapy with 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg at Day 4 post-TX (transplatation), and commenced on an immunosuppressive regimen consisting of: CsA (based on trough levels C0-h 100-250 ng/mL or C2-h 900 1300 ng/mL, according to local method), EC MPS (target dose 1440 mg/day, minimum dose 1080 mg/day at the time of randomization), Corticosteroids (a minimum dose of 10 mg prednisolone or equivalent was given at time of randomization).
10915277|NCT00634920|OG000|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
10915278|NCT00634920|OG001|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
10915279|NCT00634920|EG000|Reported Event|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
10915280|NCT00634920|EG001|Reported Event|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
10915281|NCT00634933|BG000|Baseline|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915282|NCT00634933|BG001|Baseline|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915283|NCT00634933|BG002|Baseline|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915284|NCT00634933|BG003|Baseline|Total|Total of all reporting groups
10915285|NCT00634933|FG000|Participant Flow|Placebo|Placebo infusion, matched to TRU-015 (800 milligram [mg]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
10915286|NCT00634933|FG001|Participant Flow|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 800 mg, IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
11377193|NCT03794089|OG001|Outcome|Usual PC-MHI Care|"Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care~Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic"
10915287|NCT00634933|FG002|Participant Flow|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915288|NCT00634933|FG003|Participant Flow|Placebo/TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915289|NCT00634933|FG004|Participant Flow|Placebo/TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
10915290|NCT00634933|OG000|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915291|NCT00634933|OG001|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915292|NCT00634933|OG002|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915293|NCT00634933|EG000|Reported Event|Placebo (Part A)|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
10915294|NCT00634933|EG001|Reported Event|TRU-015 Single Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-SD in the Part B of the study.
10915295|NCT00634933|EG002|Reported Event|TRU-015 Induction Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-ID in the Part B of the study.
10915296|NCT00634933|EG003|Reported Event|TRU-015 Single Dose (Part B)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
11191305|NCT02131662|BG000|Baseline|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
11191306|NCT02131662|BG001|Baseline|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
11191307|NCT02131662|BG002|Baseline|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915297|NCT00634933|EG004|Reported Event|TRU-015 Induction Dose (Part B)|Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915298|NCT00634933|EG005|Reported Event|Placebo/TRU-015 Single Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 800 mg, IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
10915299|NCT00634933|EG006|Reported Event|Placebo/TRU-015 Induction Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
10915300|NCT00635024|BG000|Baseline|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
10915301|NCT00635024|FG000|Participant Flow|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
10915302|NCT00635024|OG000|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
10915303|NCT00635024|EG000|Reported Event|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
10915304|NCT00635050|BG000|Baseline|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
10915305|NCT00635050|FG000|Participant Flow|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.~Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
10915306|NCT00635050|OG000|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
10915307|NCT00635050|OG000|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
11174374|NCT02021565|FG000|Participant Flow|Immediate Intervention Group|"Receives the in-home training intervention in-person immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology (AT) Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
10915308|NCT00635050|OG000|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin:~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
10964028|NCT00875550|BG000|Baseline|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
11377194|NCT03794089|EG000|Reported Event|Brief Anxiety Intervention|"Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management~Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills"
11377195|NCT03794089|EG001|Reported Event|Usual PC-MHI Care|"Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care~Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic"
11377196|NCT03638011|BG000|Baseline|Standard of Care|These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.
11377197|NCT03638011|BG001|Baseline|Bilateral TAP Block|"These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia.~Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL"
11377198|NCT03638011|BG002|Baseline|Total|Total of all reporting groups
11377199|NCT03638011|FG000|Participant Flow|Standard of Care|These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.
11377200|NCT03638011|FG001|Participant Flow|Bilateral TAP Block|"These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia.~Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL"
11377201|NCT03638011|OG000|Outcome|Standard of Care|These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.
11377202|NCT03638011|OG001|Outcome|Bilateral TAP Block|"These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia.~Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL"
11377203|NCT03638011|EG000|Reported Event|Standard of Care|These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.
11377204|NCT03638011|EG001|Reported Event|Bilateral TAP Block|"These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia.~Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL"
11377205|NCT03631407|BG000|Baseline|Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg)|Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
11377206|NCT03631407|BG001|Baseline|Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg)|Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
11377207|NCT03631407|BG002|Baseline|Total|Total of all reporting groups
11377208|NCT03631407|FG000|Participant Flow|Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg)|Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
11377209|NCT03631407|FG001|Participant Flow|Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg)|Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
11377210|NCT03631407|OG000|Outcome|Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg)|Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
11377211|NCT03631407|OG001|Outcome|Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg)|Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
11377212|NCT03631407|EG000|Reported Event|Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg)|Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
10915309|NCT00635050|OG000|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
10915310|NCT00635050|EG000|Reported Event|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.~Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
10915311|NCT00635089|BG000|Baseline|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
10915312|NCT00635089|FG000|Participant Flow|Open-Label Reslizumab|Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly
10915313|NCT00635089|OG000|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
10915314|NCT00635089|OG000|Outcome|Grade 0|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 0.
10915315|NCT00635089|OG001|Outcome|Grade 1|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 1.
10915316|NCT00635089|OG002|Outcome|Grade 2|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 2.
10915317|NCT00635089|OG003|Outcome|Grade 3|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 3.
10915318|NCT00635089|OG004|Outcome|Grade 4|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 4.
10915319|NCT00635089|OG000|Outcome|Maintained Diet From Beginning of Double-blind Study|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who maintained their diet from the beginning of the double-blind study (NCT00538434).
10915320|NCT00635089|OG001|Outcome|Changed Diet From Beginning of Double-blind Study|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434).
10915321|NCT00635089|OG002|Outcome|Changed by Increasing Consistency of Food|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by increasing the consistency of their food.
10915322|NCT00635089|OG003|Outcome|Changed by Eating Foods That Previously Worsened EoE|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by eating foods that previously worsened EoE.
10915323|NCT00635089|OG000|Outcome|Open-Label Reslizumab: 1 mg/kg|Open-label reslizumab IV infusion at 1 mg/kg monthly
10915324|NCT00635089|OG001|Outcome|Open-Label Reslizumab: 2 mg/kg|Open-label reslizumab IV infusion at 2 mg/kg monthly
11191308|NCT02131662|BG003|Baseline|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
11191309|NCT02131662|BG004|Baseline|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915325|NCT00635089|OG002|Outcome|Open-Label Reslizumab: 3 mg/kg|Open-label reslizumab IV infusion at 3 mg/kg monthly
10915326|NCT00635089|OG003|Outcome|Open-Label Reslizumab: Overall|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly, continued at 1 to 3 mg/kg monthly
10915327|NCT00635089|EG000|Reported Event|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
10915328|NCT00635102|BG000|Baseline|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
10915329|NCT00635102|BG001|Baseline|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
10915330|NCT00635102|BG002|Baseline|Total|Total of all reporting groups
10915331|NCT00635102|FG000|Participant Flow|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet Diagnostic and Statistical manual (DSM) IV criteria for alcohol dependence by structured clinical interview
10915332|NCT00635102|FG001|Participant Flow|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the structured clinical interview (SCID).
11191310|NCT02131662|BG005|Baseline|Total|Total of all reporting groups
11191311|NCT02131662|FG000|Participant Flow|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915333|NCT00635102|OG000|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
11191312|NCT02131662|FG001|Participant Flow|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
11191313|NCT02131662|FG002|Participant Flow|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
11191314|NCT02131662|FG003|Participant Flow|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915334|NCT00635102|OG001|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
10915335|NCT00635102|EG000|Reported Event|Alcoholic Subjects|
10915336|NCT00635102|EG001|Reported Event|Healthy Subjects|
10915337|NCT00635128|BG000|Baseline|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915338|NCT00635128|BG001|Baseline|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915339|NCT00635128|BG002|Baseline|Total|Total of all reporting groups
10915340|NCT00635128|FG000|Participant Flow|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915341|NCT00635128|FG001|Participant Flow|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915342|NCT00635128|OG000|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915343|NCT00635128|OG001|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915344|NCT00635128|OG000|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915345|NCT00635128|OG001|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915346|NCT00635128|EG000|Reported Event|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915347|NCT00635128|EG001|Reported Event|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
10915348|NCT00635154|BG000|Baseline|Anakinra With/Without Dexamethasone|
10915349|NCT00635154|FG000|Participant Flow|Anakinra With/Without Dexamethasone|
10915350|NCT00635154|OG000|Outcome|Anakinra Without Dexamethasone|Patients in this outcome received only Anakinra (100mg daily subcutaneously administered).
10915351|NCT00635154|OG000|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
10915352|NCT00635154|OG000|Outcome|Anakinra With/Without Dexamethasone|
10915353|NCT00635154|EG000|Reported Event|Anakinra With/Without Dexamethasone|
10915354|NCT00635219|BG000|Baseline|Placebo|capsules; daily; orally
10915355|NCT00635219|BG001|Baseline|Vortioxetine 2.5 mg|encapsulated tablets; orally
10915356|NCT00635219|BG002|Baseline|Vortioxetine 5 mg|encapsulated tablets; orally
10915357|NCT00635219|BG003|Baseline|Vortioxetine 10 mg|encapsulated tablets; orally
10915358|NCT00635219|BG004|Baseline|Duloxetine 60 mg|encapsulated capsules; orally
10915359|NCT00635219|BG005|Baseline|Total|Total of all reporting groups
10915360|NCT00635219|FG000|Participant Flow|Placebo|capsules; daily; orally
10915361|NCT00635219|FG001|Participant Flow|Vortioxetine 2.5 mg|encapsulated tablets; orally
10915362|NCT00635219|FG002|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; orally
10915363|NCT00635219|FG003|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; orally
10915364|NCT00635219|FG004|Participant Flow|Duloxetine 60 mg|encapsulated capsules; orally
10915365|NCT00635219|OG000|Outcome|Placebo|capsules; daily; orally
10915366|NCT00635219|OG001|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
10915367|NCT00635219|OG002|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
10915368|NCT00635219|OG003|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
10915369|NCT00635219|OG004|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
10915370|NCT00635219|EG000|Reported Event|Placebo|
10915371|NCT00635219|EG001|Reported Event|Vortioxetine 2.5 mg|
10915372|NCT00635219|EG002|Reported Event|Vortioxetine 5 mg|
10915373|NCT00635219|EG003|Reported Event|Vortioxetine 10 mg|
10915374|NCT00635219|EG004|Reported Event|Duloxetine 60 mg|
10915375|NCT00635232|BG000|Baseline|Irbesartan 300mg|Irbesartan 300 mg once daily
10915376|NCT00635232|BG001|Baseline|Placebo|Blinded Placebo Treatment
10915377|NCT00635232|BG002|Baseline|PS433540 200mg|PS433540 200mg once daily
10915378|NCT00635232|BG003|Baseline|PS433540 400mg|PS433540 400mg once daily
10915379|NCT00635232|BG004|Baseline|PS433540 800mg|PS433540 800mg once daily
10915380|NCT00635232|BG005|Baseline|Total|Total of all reporting groups
10915381|NCT00635232|FG000|Participant Flow|Irbesartan 300mg|Irbesartan 300 mg once daily
10915382|NCT00635232|FG001|Participant Flow|Placebo|Blinded Placebo Treatment
10915383|NCT00635232|FG002|Participant Flow|PS433540 200mg|PS433540 200mg once daily
10915384|NCT00635232|FG003|Participant Flow|PS433540 400mg|PS433540 400mg once daily
10915385|NCT00635232|FG004|Participant Flow|PS433540 800mg|PS433540 800mg once daily
10915386|NCT00635232|OG000|Outcome|Irbesartan 300mg|
10915387|NCT00635232|OG001|Outcome|Placebo|
10915388|NCT00635232|OG002|Outcome|PS433540 200mg|
10915389|NCT00635232|OG003|Outcome|PS433540 400mg|
10915390|NCT00635232|OG004|Outcome|PS433540 800mg|
11191315|NCT02131662|FG004|Participant Flow|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
11191316|NCT02131662|OG000|Outcome|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
11191317|NCT02131662|OG001|Outcome|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915391|NCT00635232|EG000|Reported Event|Irbesartan 300mg|Irbesartan 300 mg once daily
10915392|NCT00635232|EG001|Reported Event|Placebo|Blinded Placebo Treatment
10915393|NCT00635232|EG002|Reported Event|PS433540 200mg|PS433540 200mg once daily
10915394|NCT00635232|EG003|Reported Event|PS433540 400mg|PS433540 400mg once daily
10915395|NCT00635232|EG004|Reported Event|PS433540 800mg|PS433540 800mg once daily
10915396|NCT00635349|BG000|Baseline|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
10915397|NCT00635349|BG001|Baseline|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
10915398|NCT00635349|BG002|Baseline|Total|Total of all reporting groups
10915399|NCT00635349|FG000|Participant Flow|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
10915400|NCT00635349|FG001|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
10915401|NCT00635349|OG000|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
10915402|NCT00635349|OG001|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
10915403|NCT00635349|EG000|Reported Event|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
10915404|NCT00635349|EG001|Reported Event|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
10915405|NCT00635362|BG000|Baseline|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
11191318|NCT02131662|OG002|Outcome|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915406|NCT00635362|BG001|Baseline|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
10915407|NCT00635362|BG002|Baseline|Total|Total of all reporting groups
10915408|NCT00635362|FG000|Participant Flow|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
10915409|NCT00635362|FG001|Participant Flow|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
10915410|NCT00635362|OG000|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
10915411|NCT00635362|OG001|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
10915412|NCT00635362|EG000|Reported Event|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
10915413|NCT00635362|EG001|Reported Event|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
10915414|NCT00635427|BG000|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg)-TKT032)|VPRIV 45 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044.
10915415|NCT00635427|BG001|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625).
10915416|NCT00635427|BG002|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631).
10915417|NCT00635427|BG003|Baseline|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg) HGT-GCB-039|Imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
11191319|NCT02131662|OG003|Outcome|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915418|NCT00635427|BG004|Baseline|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
10915419|NCT00635427|BG005|Baseline|Total|Total of all reporting groups
10915420|NCT00635427|FG000|Participant Flow|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg) -TKT032)|VPRIV 45 U/kg, IV, every other week (EOW) for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044
10915421|NCT00635427|FG001|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625)
11191320|NCT02131662|OG004|Outcome|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915422|NCT00635427|FG002|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)
10915423|NCT00635427|FG003|Participant Flow|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched 60 U/kg VPRIV in HGT-GCB-044
10915424|NCT00635427|FG004|Participant Flow|VPRIV 15-60 U/kg (Parent Study VPRIV(15-60 U/kg)TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647) and continued in HGT-GCB-044 at the same dose as prescribed in TKT034
10915425|NCT00635427|OG000|Outcome|VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039)|This is the overall velaglucerase alfa group consisting of the following population: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)
10915426|NCT00635427|OG001|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
10915427|NCT00635427|OG002|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
10964029|NCT00875550|BG001|Baseline|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
11191321|NCT02131662|OG000|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug. Only subjects with valid data for this assessment were included
11191322|NCT02131662|OG000|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug. Only subjects with valid data for this assessment were included.
10915428|NCT00635427|OG000|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)
10915429|NCT00635427|OG001|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
10915430|NCT00635427|EG000|Reported Event|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
10915431|NCT00635427|EG001|Reported Event|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)
10915432|NCT00635427|EG002|Reported Event|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
10915433|NCT00635453|BG000|Baseline|I, Intervention|"Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the Ten Steps recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions.~Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years."
10915434|NCT00635453|BG001|Baseline|II, Control|Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
10915435|NCT00635453|BG002|Baseline|Total|Total of all reporting groups
10915436|NCT00635453|FG000|Participant Flow|I, Intervention|"Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the Ten Steps recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions.~Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years."
11234012|NCT02431793|BG001|Baseline|EMC2 Strategy|"Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.~A single-page medication information sheet with content from a patients perspective and following health literacy best practices.~Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.~Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed on the prescription."
10915437|NCT00635453|FG001|Participant Flow|II, Control|Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
10915438|NCT00635453|OG000|Outcome|I, Intervention|"Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the Ten Steps recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions.~Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years."
10915439|NCT00635453|OG001|Outcome|II, Control|Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
10915440|NCT00635453|EG000|Reported Event|I, Intervention|"Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the Ten Steps recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions.~Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years."
10964030|NCT00875550|BG002|Baseline|Total|Total of all reporting groups
10915441|NCT00635453|EG001|Reported Event|II, Control|Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
10915442|NCT00635479|BG000|Baseline|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
10915443|NCT00635479|BG001|Baseline|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
10915444|NCT00635479|BG002|Baseline|Total|Total of all reporting groups
10915445|NCT00635479|FG000|Participant Flow|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
10915446|NCT00635479|FG001|Participant Flow|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
10915447|NCT00635479|OG000|Outcome|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
10915448|NCT00635479|OG001|Outcome|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
10915449|NCT00635479|EG000|Reported Event|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
10915450|NCT00635479|EG001|Reported Event|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
10915451|NCT00635492|BG000|Baseline|Exenatide BID|Daily dose ranging from 5-20 ug
10915452|NCT00635492|BG001|Baseline|Insulin|Insulin at a dose selected by the HCP and patient
10915453|NCT00635492|BG002|Baseline|Total|Total of all reporting groups
10915454|NCT00635492|FG000|Participant Flow|Exenatide BID|Daily dose ranging from 5-20 mcg
10915455|NCT00635492|FG001|Participant Flow|Insulin|Insulin at a dose selected by the health care provided (HCP) and patient
10915456|NCT00635492|OG000|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
10915457|NCT00635492|OG001|Outcome|Insulin|insulin at a dose selected by the HCP and patient
10915458|NCT00635492|OG000|Outcome|Exenatide BID|Daily dose ranging from 5-20mcg/day
10915459|NCT00635492|OG001|Outcome|Insulin|Insulin at a dose selected by the HCP and patient
10915460|NCT00635492|OG000|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
10915461|NCT00635492|OG000|Outcome|Insulin Cohort|insulin at a dose selected by the HCP and patient
10915462|NCT00635492|EG000|Reported Event|Exenatide BID|Daily dose ranging from 5-20 ug
10915463|NCT00635492|EG001|Reported Event|Insulin|Insulin at a dose selected by the HCP and patient
10915464|NCT00635570|BG000|Baseline|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
10915465|NCT00635570|BG001|Baseline|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
10915466|NCT00635570|BG002|Baseline|Total|Total of all reporting groups
10915467|NCT00635570|FG000|Participant Flow|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
10915468|NCT00635570|FG001|Participant Flow|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
10915469|NCT00635570|OG000|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
11191323|NCT02131662|OG000|Outcome|Method Interchange Analysis Set|Method interchange analysis set (N=399) for the assessment of the interchangeability of the menstrual pictogram (MP) and the alkaline hematin (AH) method to judge menstrual blood loss (MBL) included subjects with sanitary product data for which there was a matching pair of MP score and AH value available.
10915470|NCT00635570|OG001|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
10915471|NCT00635570|EG000|Reported Event|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
10915472|NCT00635570|EG001|Reported Event|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
10915473|NCT00635609|BG000|Baseline|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
10915474|NCT00635609|BG001|Baseline|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
10915475|NCT00635609|BG002|Baseline|Total|Total of all reporting groups
10915476|NCT00635609|FG000|Participant Flow|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
10915477|NCT00635609|FG001|Participant Flow|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
10915478|NCT00635609|OG000|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
10915479|NCT00635609|OG001|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
10915480|NCT00635609|EG000|Reported Event|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
10915481|NCT00635609|EG001|Reported Event|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
10915482|NCT00635648|BG000|Baseline|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
10915483|NCT00635648|FG000|Participant Flow|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
11191324|NCT02131662|OG000|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug.
10915484|NCT00635648|OG000|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
10915485|NCT00635648|EG000|Reported Event|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
10915486|NCT00635661|BG000|Baseline|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
10915487|NCT00635661|FG000|Participant Flow|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
10915488|NCT00635661|OG000|Outcome|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
10915489|NCT00635661|EG000|Reported Event|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
10915490|NCT00635700|BG000|Baseline|Ziprasidone|ziprasidone: 20-160 mg/d
10915491|NCT00635700|BG001|Baseline|Placebo|placebo: placebo
10915492|NCT00635700|BG002|Baseline|Total|Total of all reporting groups
10915493|NCT00635700|FG000|Participant Flow|Ziprasidone|ziprasidone: 20-160 mg/d
10915494|NCT00635700|FG001|Participant Flow|Placebo|placebo: placebo
10915495|NCT00635700|OG000|Outcome|Ziprasidone|ziprasidone: 20-160 mg/d
10915496|NCT00635700|OG001|Outcome|Placebo|placebo: placebo
10915497|NCT00635700|EG000|Reported Event|Ziprasidone|ziprasidone: 20-160 mg/d
10915498|NCT00635700|EG001|Reported Event|Placebo|placebo: placebo
10915499|NCT00635739|BG000|Baseline|A,1 (Intervention)|Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
10915500|NCT00635739|BG001|Baseline|A,2 (Control)|Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
10915501|NCT00635739|BG002|Baseline|Total|Total of all reporting groups
10915502|NCT00635739|FG000|Participant Flow|Whey Protein|Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
10915503|NCT00635739|FG001|Participant Flow|Placebo|Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
10915504|NCT00635739|OG000|Outcome|Whey Protein|Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
10915505|NCT00635739|OG001|Outcome|Placebo|Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
10915506|NCT00635739|EG000|Reported Event|Whey Protein|Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
10915507|NCT00635739|EG001|Reported Event|Placebo|Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
10915508|NCT00635778|BG000|Baseline|Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg|Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915509|NCT00635778|BG001|Baseline|Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915510|NCT00635778|BG002|Baseline|Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915511|NCT00635778|BG003|Baseline|Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915512|NCT00635778|BG004|Baseline|Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915513|NCT00635778|BG005|Baseline|Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915514|NCT00635778|BG006|Baseline|Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915515|NCT00635778|BG007|Baseline|Total|Total of all reporting groups
10915516|NCT00635778|FG000|Participant Flow|Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg|Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by intravenous (IV) infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
11191325|NCT02131662|EG000|Reported Event|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915517|NCT00635778|FG001|Participant Flow|Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915518|NCT00635778|FG002|Participant Flow|Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915519|NCT00635778|FG003|Participant Flow|Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915520|NCT00635778|FG004|Participant Flow|Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915521|NCT00635778|FG005|Participant Flow|Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915522|NCT00635778|FG006|Participant Flow|Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915523|NCT00635778|OG000|Outcome|Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg|Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915524|NCT00635778|OG001|Outcome|Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915525|NCT00635778|OG002|Outcome|Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915526|NCT00635778|OG003|Outcome|Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915527|NCT00635778|OG004|Outcome|Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915528|NCT00635778|OG005|Outcome|Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915529|NCT00635778|OG006|Outcome|Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915530|NCT00635778|OG000|Outcome|Pooled Participants Who Received Dalotuzumab|Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
10915531|NCT00635778|EG000|Reported Event|Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg|Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
11240612|NCT02480764|BG002|Baseline|Valsartan 160 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks.
10915532|NCT00635778|EG001|Reported Event|Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915533|NCT00635778|EG002|Reported Event|Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915534|NCT00635778|EG003|Reported Event|Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915535|NCT00635778|EG004|Reported Event|Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg|Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
11240613|NCT02480764|BG003|Baseline|Total|Total of all reporting groups
10915536|NCT00635778|EG005|Reported Event|Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915537|NCT00635778|EG006|Reported Event|Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg|Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
10915538|NCT00635804|BG000|Baseline|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
10915539|NCT00635804|BG001|Baseline|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
10915540|NCT00635804|BG002|Baseline|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
10915541|NCT00635804|BG003|Baseline|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
10915542|NCT00635804|BG004|Baseline|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
10915543|NCT00635804|BG005|Baseline|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
10915544|NCT00635804|BG006|Baseline|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
10915545|NCT00635804|BG007|Baseline|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
10915546|NCT00635804|BG008|Baseline|Total|Total of all reporting groups
10915547|NCT00635804|FG000|Participant Flow|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
10915548|NCT00635804|FG001|Participant Flow|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
10915549|NCT00635804|FG002|Participant Flow|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
10915550|NCT00635804|FG003|Participant Flow|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
10915551|NCT00635804|FG004|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
10915552|NCT00635804|FG005|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
10915553|NCT00635804|FG006|Participant Flow|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
10915554|NCT00635804|FG007|Participant Flow|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
10915555|NCT00635804|OG000|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
10915556|NCT00635804|OG001|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
10915557|NCT00635804|OG002|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
10915558|NCT00635804|OG003|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
10915559|NCT00635804|OG004|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
10915560|NCT00635804|OG005|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
10915561|NCT00635804|OG006|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
10915562|NCT00635804|OG007|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
10915563|NCT00635804|OG004|Outcome|Pt 2: MK-3281 800 mg BID (Panels E+F)|GT1/GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
10915564|NCT00635804|OG005|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
10915565|NCT00635804|OG006|Outcome|Placebo|HCV-infected participants in Part II who received dose-matched placebo to MK-03281 orally BID for 7 consecutive days.
10915566|NCT00635804|EG000|Reported Event|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
10915567|NCT00635804|EG001|Reported Event|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
10915568|NCT00635804|EG002|Reported Event|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
10915569|NCT00635804|EG003|Reported Event|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
10915570|NCT00635804|EG004|Reported Event|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
10915571|NCT00635804|EG005|Reported Event|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
11377213|NCT03631407|EG001|Reported Event|Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg)|Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
10915572|NCT00635804|EG006|Reported Event|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
10915573|NCT00635804|EG007|Reported Event|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
10915574|NCT00635817|BG000|Baseline|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
10915575|NCT00635817|BG001|Baseline|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
10915576|NCT00635817|BG002|Baseline|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
10915577|NCT00635817|BG003|Baseline|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
10915578|NCT00635817|BG004|Baseline|Total|Total of all reporting groups
10915579|NCT00635817|FG000|Participant Flow|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
10915580|NCT00635817|FG001|Participant Flow|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
10915581|NCT00635817|FG002|Participant Flow|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
10915582|NCT00635817|FG003|Participant Flow|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
10915583|NCT00635817|OG000|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
10915584|NCT00635817|OG001|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
10915585|NCT00635817|OG002|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
10915586|NCT00635817|OG003|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
10915587|NCT00635817|OG000|Outcome|Leuprolide Acetate 11.25 mg|All subjects from both treatment groups who received 11.25 mg leuprolide acetate, both treatment naive and previously treated, were combined.
10915588|NCT00635817|OG001|Outcome|Leuprolide Acetate 30 mg|All subjects from both treatment groups who received 30 mg leuprolide acetate, both treatment naive and previously treated, were combined.
10915589|NCT00635817|EG000|Reported Event|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
10915590|NCT00635817|EG001|Reported Event|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
10915591|NCT00635817|EG002|Reported Event|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
10915592|NCT00635817|EG003|Reported Event|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
10915593|NCT00635830|BG000|Baseline|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
10915594|NCT00635830|BG001|Baseline|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
10915595|NCT00635830|BG002|Baseline|Total|Total of all reporting groups
10915596|NCT00635830|FG000|Participant Flow|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
10915597|NCT00635830|FG001|Participant Flow|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
10915598|NCT00635830|OG000|Outcome|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
10915599|NCT00635830|OG001|Outcome|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
10915600|NCT00635830|EG000|Reported Event|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
11191326|NCT02131662|EG001|Reported Event|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915601|NCT00635830|EG001|Reported Event|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
10915602|NCT00635999|BG000|Baseline|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
10915603|NCT00635999|BG001|Baseline|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
10915604|NCT00635999|BG002|Baseline|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
10915605|NCT00635999|BG003|Baseline|Total|Total of all reporting groups
10915606|NCT00635999|FG000|Participant Flow|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
10915607|NCT00635999|FG001|Participant Flow|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
10915608|NCT00635999|FG002|Participant Flow|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
10915609|NCT00635999|OG000|Outcome|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
10915610|NCT00635999|OG001|Outcome|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
10915611|NCT00635999|OG002|Outcome|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
10915612|NCT00635999|EG000|Reported Event|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
10915613|NCT00635999|EG001|Reported Event|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
10915614|NCT00635999|EG002|Reported Event|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
10915615|NCT00636077|BG000|Baseline|All Study Participants|
10915616|NCT00636077|FG000|Participant Flow|HD-C4 Big First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Big dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
10915617|NCT00636077|FG001|Participant Flow|HD-C4 Small First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Small dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
10915618|NCT00636077|FG002|Participant Flow|Optiflux F160NR First|Patients in this Arm will receive 3 consecutive treatments with the F160NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
10915619|NCT00636077|FG003|Participant Flow|Optiflux F200NR First|Patients in this Arm will receive 3 consecutive treatments with the F200NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
10915620|NCT00636077|OG000|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
10915621|NCT00636077|OG001|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
10915622|NCT00636077|OG002|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
10915623|NCT00636077|OG003|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
10915624|NCT00636077|EG000|Reported Event|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
10915625|NCT00636077|EG001|Reported Event|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
11191327|NCT02131662|EG002|Reported Event|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915626|NCT00636077|EG002|Reported Event|F160NR|3 consecutive treatments with the F160NR dialyzer.
10915627|NCT00636077|EG003|Reported Event|F200NR|3 consecutive treatments with the F200NR dialyzer.
10915628|NCT00636155|BG000|Baseline|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
10915629|NCT00636155|FG000|Participant Flow|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
10915630|NCT00636155|OG000|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
10915631|NCT00636155|EG000|Reported Event|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
10915632|NCT00636168|BG000|Baseline|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
10915633|NCT00636168|BG001|Baseline|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
11174375|NCT02021565|FG001|Participant Flow|Delayed Intervention Control Group|"Receives the in-home training intervention in-person six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
11174376|NCT02021565|OG000|Outcome|Immediate Intervention Group|"Receives the in-home training intervention immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
10915634|NCT00636168|BG002|Baseline|Total|Total of all reporting groups
10915635|NCT00636168|FG000|Participant Flow|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
10915636|NCT00636168|FG001|Participant Flow|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
10915637|NCT00636168|OG000|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
10915638|NCT00636168|OG001|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
10915639|NCT00636168|EG000|Reported Event|IPILIMUMAB 10 MG/KG|
10915640|NCT00636168|EG001|Reported Event|PLACEBO|
10915641|NCT00636181|BG000|Baseline|Auto Aflex|"auto adjusting positive pressure therapy with AFLEX~Auto AFlex: Positive pressure therapy treatment"
10915642|NCT00636181|BG001|Baseline|Auto CPAP|"auto adjusting positive pressure therapy~Auto CPAP: Positive pressure therapy treatment"
10915643|NCT00636181|BG002|Baseline|CPAP|"continuous positive airway pressure~CPAP: Positive pressure therapy treatment"
10915644|NCT00636181|BG003|Baseline|Total|Total of all reporting groups
10915645|NCT00636181|FG000|Participant Flow|Auto Aflex|"auto adjusting positive pressure therapy with AFLEX~Auto AFlex: Positive pressure therapy treatment"
10915646|NCT00636181|FG001|Participant Flow|Auto CPAP|"auto adjusting positive pressure therapy~Auto CPAP: Positive pressure therapy treatment"
10915647|NCT00636181|FG002|Participant Flow|CPAP|"continuous positive airway pressure~CPAP: Positive pressure therapy treatment"
10915648|NCT00636181|OG000|Outcome|Auto Aflex|"auto adjusting positive pressure therapy with AFLEX~Auto AFlex: Positive pressure therapy treatment"
10851473|NCT00306527|OG006|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
10851474|NCT00306527|OG007|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
10851475|NCT00306527|EG000|Reported Event|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
10851476|NCT00306527|EG001|Reported Event|Adults (cTIV/TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
10851477|NCT00306527|EG002|Reported Event|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
10851478|NCT00306527|EG003|Reported Event|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
10851479|NCT00306592|BG000|Baseline|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
10851480|NCT00306592|FG000|Participant Flow|Natalizumab Study 101-MS-322 (NCT00306592)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
10851481|NCT00306592|FG001|Participant Flow|Natalizumab Study 101-MS-321 (NCT00297232)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).
10851482|NCT00306592|OG000|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
10851483|NCT00306592|EG000|Reported Event|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
10851484|NCT00306670|BG000|Baseline|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
10851485|NCT00306670|BG001|Baseline|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
10851486|NCT00306670|BG002|Baseline|Total|Total of all reporting groups
10851487|NCT00306670|FG000|Participant Flow|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
10851488|NCT00306670|FG001|Participant Flow|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
10851489|NCT00306670|OG000|Outcome|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
10851490|NCT00306670|OG001|Outcome|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
10851491|NCT00306670|EG000|Reported Event|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
10851492|NCT00306670|EG001|Reported Event|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
10851493|NCT00306787|BG000|Baseline|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
10851494|NCT00306787|BG001|Baseline|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
10851495|NCT00306787|BG002|Baseline|Total|Total of all reporting groups
10851496|NCT00306787|FG000|Participant Flow|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
10851497|NCT00306787|FG001|Participant Flow|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
10915649|NCT00636181|OG001|Outcome|Auto CPAP|"auto adjusting positive pressure therapy~Auto CPAP: Positive pressure therapy treatment"
10915650|NCT00636181|OG002|Outcome|CPAP|"continuous positive airway pressure~CPAP: Positive pressure therapy treatment"
10915651|NCT00636181|EG000|Reported Event|Auto Aflex|"auto adjusting positive pressure therapy with AFLEX~Auto AFlex: Positive pressure therapy treatment"
10915652|NCT00636181|EG001|Reported Event|Auto CPAP|"auto adjusting positive pressure therapy~Auto CPAP: Positive pressure therapy treatment"
10915653|NCT00636181|EG002|Reported Event|CPAP|"continuous positive airway pressure~CPAP: Positive pressure therapy treatment"
10915654|NCT00636194|BG000|Baseline|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
10915655|NCT00636194|BG001|Baseline|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
10915656|NCT00636194|BG002|Baseline|Total|Total of all reporting groups
10915657|NCT00636194|FG000|Participant Flow|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
10915658|NCT00636194|FG001|Participant Flow|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
10915659|NCT00636194|OG000|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
10915660|NCT00636194|OG001|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
10915661|NCT00636194|EG000|Reported Event|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
10915662|NCT00636194|EG001|Reported Event|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
10915663|NCT00636207|BG000|Baseline|Part I|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
10915664|NCT00636207|BG001|Baseline|Part II|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) or Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
10915665|NCT00636207|BG002|Baseline|Part III|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
10915666|NCT00636207|BG003|Baseline|Total|Total of all reporting groups
10915667|NCT00636207|FG000|Participant Flow|Part I - Montelukast|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg). Each dose was separated by at least a 3-day washout period.
10915668|NCT00636207|FG001|Participant Flow|Part I - Montelukast and Placebo|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
10915669|NCT00636207|FG002|Participant Flow|Part II - Montelukast|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
10915670|NCT00636207|FG003|Participant Flow|Part II - Placebo|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive QD doses of inhaled Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
11377214|NCT03617926|BG000|Baseline|Test Product|Water-based lotion (medical device)
10915671|NCT00636207|FG004|Participant Flow|Part III - Montelukast|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
10915672|NCT00636207|FG005|Participant Flow|Part III - Montelukast and Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
10915673|NCT00636207|FG006|Participant Flow|Part III - Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
10915674|NCT00636207|OG000|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
10915675|NCT00636207|OG001|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
10915676|NCT00636207|OG002|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
11377215|NCT03617926|BG001|Baseline|Reference|RID Shampoo
10915677|NCT00636207|OG003|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
10915678|NCT00636207|OG004|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
10915679|NCT00636207|OG005|Outcome|Placebo|Participants receiving Placebo inhalation powder
10915680|NCT00636207|OG002|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
10915681|NCT00636207|OG003|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
10915682|NCT00636207|OG004|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
10915683|NCT00636207|OG005|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
10915684|NCT00636207|OG000|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
10915685|NCT00636207|OG001|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
10915686|NCT00636207|OG002|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
10915687|NCT00636207|EG000|Reported Event|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
10915688|NCT00636207|EG001|Reported Event|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
10915689|NCT00636207|EG002|Reported Event|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
11377216|NCT03617926|BG002|Baseline|Total|Total of all reporting groups
10915690|NCT00636207|EG003|Reported Event|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
10915691|NCT00636207|EG004|Reported Event|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
10915692|NCT00636207|EG005|Reported Event|Placebo|Participants receiving Placebo inhalation powder
10915693|NCT00636220|BG000|Baseline|Confirmed HIV Infection|participants with known (clinically or serologically) confirmed HIV infection.
10915694|NCT00636220|FG000|Participant Flow|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
10915695|NCT00636220|OG000|Outcome|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
10915696|NCT00636220|EG000|Reported Event|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
10915697|NCT00636363|BG000|Baseline|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
10915698|NCT00636363|BG001|Baseline|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
10915699|NCT00636363|BG002|Baseline|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
10915700|NCT00636363|BG003|Baseline|Total|Total of all reporting groups
10915701|NCT00636363|FG000|Participant Flow|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
10915702|NCT00636363|FG001|Participant Flow|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
10915703|NCT00636363|FG002|Participant Flow|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
10915704|NCT00636363|OG000|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
10915705|NCT00636363|OG001|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
10915706|NCT00636363|OG002|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
10915707|NCT00636363|EG000|Reported Event|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
10915708|NCT00636363|EG001|Reported Event|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
10915709|NCT00636363|EG002|Reported Event|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
10915710|NCT00636389|BG000|Baseline|All Study Participants|
10915711|NCT00636389|FG000|Participant Flow|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
10915712|NCT00636389|FG001|Participant Flow|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
10915713|NCT00636389|OG000|Outcome|HD-C4|
10915714|NCT00636389|OG001|Outcome|210H|
10915715|NCT00636389|EG000|Reported Event|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
10915716|NCT00636389|EG001|Reported Event|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
10963126|NCT00870363|EG001|Reported Event|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963127|NCT00870363|EG002|Reported Event|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963128|NCT00870363|EG003|Reported Event|HIV Negative Controls Not on ART|HIV-negative
10963129|NCT00870467|BG000|Baseline|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
10963130|NCT00870467|BG001|Baseline|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
10963131|NCT00870467|BG002|Baseline|Total|Total of all reporting groups
10963132|NCT00870467|FG000|Participant Flow|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
11191328|NCT02131662|EG003|Reported Event|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10915717|NCT00636441|BG000|Baseline|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915718|NCT00636441|BG001|Baseline|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915719|NCT00636441|BG002|Baseline|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915720|NCT00636441|BG003|Baseline|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915721|NCT00636441|BG004|Baseline|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915722|NCT00636441|BG005|Baseline|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915723|NCT00636441|BG006|Baseline|Screen Failure|
10915724|NCT00636441|BG007|Baseline|Total|Total of all reporting groups
10915725|NCT00636441|FG000|Participant Flow|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915726|NCT00636441|FG001|Participant Flow|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915727|NCT00636441|FG002|Participant Flow|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915728|NCT00636441|FG003|Participant Flow|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915729|NCT00636441|FG004|Participant Flow|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915730|NCT00636441|FG005|Participant Flow|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915731|NCT00636441|FG006|Participant Flow|Screen Failure|
10915732|NCT00636441|OG000|Outcome|Guided Arm|Genomically-guided treatment allocation.
10915733|NCT00636441|OG001|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
10915734|NCT00636441|EG000|Reported Event|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915735|NCT00636441|EG001|Reported Event|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915736|NCT00636441|EG002|Reported Event|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915737|NCT00636441|EG003|Reported Event|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915738|NCT00636441|EG004|Reported Event|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915739|NCT00636441|EG005|Reported Event|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
10915740|NCT00636441|EG006|Reported Event|Screen Failures|Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
10915741|NCT00636506|BG000|Baseline|AMS 700 IPP 2005 Implant Group|Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction.
10915742|NCT00636506|FG000|Participant Flow|AMS 700 IPP 2005 Implant Group|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
10915743|NCT00636506|OG000|Outcome|AMS 700 IPP 2005 Implant Group at 4-8 Weeks|Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.
10915744|NCT00636506|OG000|Outcome|AMS 700 IPP 2005 Implant Group|"Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.~AMS 700 IPP with MS Pump: AMS 700 Series Inflatable Penile Prosthesis with MS Pump"
10915745|NCT00636506|OG000|Outcome|AMS 700 IPP 2005 Implant Group at 4-8 Weeks Follow-up|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 4-8 weeks follow-up.
10915746|NCT00636506|OG001|Outcome|AMS 700 IPP 2005 Implant Group at 3 Months Follow-up|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.
10915747|NCT00636506|OG002|Outcome|AMS 700 IPP 2005 Implant Group at 6 Months Follow-up|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
10915748|NCT00636506|OG000|Outcome|AMS 700 IPP 2005 Implant Group at 3 Months Follow-up|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
10915749|NCT00636506|OG001|Outcome|AMS 700 IPP 2005 Implant Group at 6 Months Follow-up|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
10915750|NCT00636506|OG000|Outcome|AMS 700 IPP 2005 Implant Group at 3 Months|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 3 month follow-up visit.
10915751|NCT00636506|OG001|Outcome|AMS 700 IPP 2005 Implant Group at 6 Months|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 6 month follow-up visit.
10915752|NCT00636506|OG000|Outcome|AMS 700 IPP 2005 Implant Group|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
10915753|NCT00636506|OG000|Outcome|AMS 700 IPP 2005 Implant Group at 3 Months Follow-up|Subjects implanted with the AMS 700 IPP 2005 who attended the 3 month follow-up visit
10915754|NCT00636506|OG001|Outcome|AMS 700 IPP 2005 Implant Group at 6 Months Follow-up|Subjects implanted with the AMS 700 IPP 2005 who attended the 6 month follow-up visit
10915755|NCT00636506|OG000|Outcome|3 Months - AMS 700 IPP 2005 Implant Group|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 3 month follow-up visit.
10915756|NCT00636506|OG001|Outcome|6 Months - AMS 700 IPP 2005 Implant Group|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 6 month follow-up visit.
10915757|NCT00636506|OG000|Outcome|3 Months - AMS 700 IPP 2005 Implant Group|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction attending the 3 month visit.
10915758|NCT00636506|OG001|Outcome|6 Months - AMS 700 IPP 2005 Implant Group|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction attending the 6 month visit.
10915759|NCT00636506|OG000|Outcome|AMS Tactile Pump|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
10915760|NCT00636506|OG001|Outcome|Standard AMS 700 Pump|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
10915761|NCT00636506|OG000|Outcome|AMS 700 IPP 2005 Implant Group With RTEs|Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction for whom physicians used RTEs.
10915762|NCT00636506|EG000|Reported Event|AMS 700 IPP 2005 Implant Group|Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction.
10915763|NCT00636610|BG000|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
10915764|NCT00636610|BG001|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
10915765|NCT00636610|BG002|Baseline|Total|Total of all reporting groups
10915766|NCT00636610|FG000|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
10915767|NCT00636610|FG001|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
10915768|NCT00636610|OG000|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
10915769|NCT00636610|OG001|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
10915770|NCT00636610|EG000|Reported Event|Placebo With FOLFOX+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
10915771|NCT00636610|EG001|Reported Event|Vismodegib (GDC-0449) With FOLFOX+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
10915772|NCT00636610|EG002|Reported Event|Placebo With FOLFIRI+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
10915773|NCT00636610|EG003|Reported Event|Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
10915774|NCT00636636|BG000|Baseline|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
10915775|NCT00636636|BG001|Baseline|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
10915776|NCT00636636|BG002|Baseline|Total|Total of all reporting groups
10915777|NCT00636636|FG000|Participant Flow|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
11377217|NCT03617926|FG000|Participant Flow|Test Product|"Water-based lotion (internal code (X92001666)~X92001666: the X92001666 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7."
10915778|NCT00636636|FG001|Participant Flow|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
10915779|NCT00636636|OG000|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
10915780|NCT00636636|OG001|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
10915781|NCT00636636|EG000|Reported Event|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
10915782|NCT00636636|EG001|Reported Event|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
11377218|NCT03617926|FG001|Participant Flow|Reference|"Commercial, pyrethrin-based shampoo (RID shampoo)~RID shampoo: Active Comparator: RID shampoo The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7."
11377219|NCT03617926|OG000|Outcome|Test Product|Water-based lotion (internal code (X92001666))
11377220|NCT03617926|OG000|Outcome|Reference Product|RID Shampoo (pyrethrum-based)
11377221|NCT03617926|OG000|Outcome|Test Product|Water-based lotion (medical device)
11377222|NCT03617926|OG000|Outcome|Reference|RID Shampoo
11377223|NCT03617926|OG000|Outcome|Test Product|Water-based lotion (internal code (X92001666)
11377224|NCT03617926|OG001|Outcome|Reference|RID Shampoo
11377225|NCT03617926|OG000|Outcome|Test Product|Evaluation of erythema, paraesthesia, excoriations, pyrodema, puritus and abnormalities
11377226|NCT03617926|EG000|Reported Event|Test Product|"Water-based lotion (internal code (X92001666)~X92001666: the X92001666 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7."
11377227|NCT03617926|EG001|Reported Event|Reference|"Commercial, pyrethrin-based shampoo (RID shampoo)~RID shampoo: Active Comparator: RID shampoo The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7."
11377228|NCT03457129|BG000|Baseline|Fycompa 2 Week Titration Intervals|"Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.~Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures."
11377229|NCT03457129|BG001|Baseline|Fycompa 3 Week Titration Intervals|"Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.~Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures."
11377230|NCT03457129|BG002|Baseline|Total|Total of all reporting groups
11377231|NCT03457129|FG000|Participant Flow|Fycompa 2 Week Titration Intervals|"Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.~Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures."
11377232|NCT03457129|FG001|Participant Flow|Fycompa 3 Week Titration Intervals|"Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.~Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures."
11377233|NCT03457129|OG000|Outcome|Fycompa 2 Week Titration Intervals|"Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.~Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures."
10915783|NCT00636649|BG000|Baseline|Escitalopram|
10915784|NCT00636649|BG001|Baseline|Placebo|
10915785|NCT00636649|BG002|Baseline|Total|Total of all reporting groups
10915786|NCT00636649|FG000|Participant Flow|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
10915787|NCT00636649|FG001|Participant Flow|Placebo|Dosing of matching placebo was identical.
10915788|NCT00636649|OG000|Outcome|Escitalopram|
10915789|NCT00636649|OG001|Outcome|Placebo|
10915790|NCT00636649|OG000|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
10915791|NCT00636649|OG001|Outcome|Placebo|Dosing of matching placebo was identical.
10915792|NCT00636649|OG000|Outcome|Placebo|Dosing of matching placebo was identical.
10915793|NCT00636649|OG001|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
10915794|NCT00636649|EG000|Reported Event|Escitalopram|
10915795|NCT00636649|EG001|Reported Event|Placebo|
10915796|NCT00636675|BG000|Baseline|Falls Qualty Improvement (QI)|"Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.~Falls QI: Falls uses the Falls Management Program; it is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. Falls is delivered over 3 months. Components include:~In-House Falls Coordinator training on content and falls processes.~Case-based modules about fall prevention and tailored for various team members.~Academic Detailing in which researcher consults with staff regarding challenging residents with falls.~Audit and Feedback. Discussions about comparison of nursing home's current practice on fall-related process and outcome measures, and how it compares with the median and the 90th percentile of peer NHs.~Toolbox: Handbook of useful measures and worksheets."
10915797|NCT00636675|BG001|Baseline|Connect & Falls Quality Improviement (QI)|"Connect is delivered, followed by Falls. Behavioral intervention to improve staff interaction for better care planning and execution. Connect will be delivered, followed by the Falls quality improvement intervention.~Connect: Connect, delivered over 12 weeks, helps nursing home staff learn interactions that increase exchange of new information, number and quality of connections among staff, and improve problem-solving about patient care. Protocols:~In-class learning sessions introduce interaction strategies.~Relationship map protocols assist staff to examine existing interaction patterns and agree on goals for improvement. Individuals develop their own relationship maps and use them to practice new horizontal and vertical connections and self-monitoring their own interactions.~Researcher facilitates authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role."
10915798|NCT00636675|BG002|Baseline|Total|Total of all reporting groups
10915799|NCT00636675|FG000|Participant Flow|Fall QI|"Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.~Falls QI: Falls uses the Falls Management Program (AHRQ); it is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. Falls is delivered over 3 months. Components include:~In-House Falls Coordinator training on content and falls processes.~Case-based modules about fall prevention and tailored for various team members.~Academic Detailing in which researcher consults with staff regarding challenging residents with falls.~Audit and Feedback. Discussions about comparison of nursing home's current practice on fall-related process and outcome measures, and how it compares with the median and the 90th percentile of peer NHs.~Toolbox: Handbook of useful measures and worksheets."
10915800|NCT00636675|FG001|Participant Flow|Connect & Falls QI|"Connect is delivered, followed by Falls. Behavioral intervention to improve staff interaction for better care planning and execution. Connect will be delivered, followed by the Falls quality improvement intervention.~Connect: Connect, delivered over 12 weeks, helps nursing home staff learn interactions that increase exchange of new information, number and quality of connections among staff, and improve problem-solving about patient care. Protocols:~In-class learning sessions introduce interaction strategies.~Relationship map protocols assist staff to examine existing interaction patterns and agree on goals for improvement. Individuals develop their own relationship maps and use them to practice new horizontal and vertical connections and self-monitoring their own interactions.~Researcher facilitates authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role."
10915801|NCT00636675|OG000|Outcome|Fall QI|"Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.~Falls QI: Falls uses the Falls Management Program (AHRQ); it is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. Falls is delivered over 3 months. Components include:~In-House Falls Coordinator training on content and falls processes.~Case-based modules about fall prevention and tailored for various team members.~Academic Detailing in which researcher consults with staff regarding challenging residents with falls.~Audit and Feedback. Discussions about comparison of nursing home's current practice on fall-related process and outcome measures, and how it compares with the median and the 90th percentile of peer NHs.~Toolbox: Handbook of useful measures and worksheets."
10915802|NCT00636675|OG001|Outcome|Connect & Falls QI|"Connect is delivered, followed by Falls. Behavioral intervention to improve staff interaction for better care planning and execution. Connect will be delivered, followed by the Falls quality improvement intervention.~Connect: Connect, delivered over 12 weeks, helps nursing home staff learn interactions that increase exchange of new information, number and quality of connections among staff, and improve problem-solving about patient care. Protocols:~In-class learning sessions introduce interaction strategies.~Relationship map protocols assist staff to examine existing interaction patterns and agree on goals for improvement. Individuals develop their own relationship maps and use them to practice new horizontal and vertical connections and self-monitoring their own interactions.~Researcher facilitates authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role."
10915803|NCT00636675|EG000|Reported Event|Fall QI|"Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.~Falls QI: Falls uses the Falls Management Program (AHRQ); it is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. Falls is delivered over 3 months. Components include:~In-House Falls Coordinator training on content and falls processes.~Case-based modules about fall prevention and tailored for various team members.~Academic Detailing in which researcher consults with staff regarding challenging residents with falls.~Audit and Feedback. Discussions about comparison of nursing home's current practice on fall-related process and outcome measures, and how it compares with the median and the 90th percentile of peer NHs.~Toolbox: Handbook of useful measures and worksheets."
10915804|NCT00636675|EG001|Reported Event|Connect & Falls QI|"Connect is delivered, followed by Falls. Behavioral intervention to improve staff interaction for better care planning and execution. Connect will be delivered, followed by the Falls quality improvement intervention.~Connect: Connect, delivered over 12 weeks, helps nursing home staff learn interactions that increase exchange of new information, number and quality of connections among staff, and improve problem-solving about patient care. Protocols:~In-class learning sessions introduce interaction strategies.~Relationship map protocols assist staff to examine existing interaction patterns and agree on goals for improvement. Individuals develop their own relationship maps and use them to practice new horizontal and vertical connections and self-monitoring their own interactions.~Researcher facilitates authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role."
10915805|NCT00636701|BG000|Baseline|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
10915806|NCT00636701|BG001|Baseline|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
10915807|NCT00636701|BG002|Baseline|Total|Total of all reporting groups
10915808|NCT00636701|FG000|Participant Flow|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
10915809|NCT00636701|FG001|Participant Flow|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
10915810|NCT00636701|OG000|Outcome|Number of Participants Who Received Primed rTMS|Number of participants who received 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
10915811|NCT00636701|OG001|Outcome|Number of Participants Who Received Unprimed rTMS|Number of participants who received 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
10915812|NCT00636701|EG000|Reported Event|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
10915813|NCT00636701|EG001|Reported Event|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
10915814|NCT00636792|BG000|Baseline|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
10915815|NCT00636792|FG000|Participant Flow|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
10915816|NCT00636792|OG000|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
10915817|NCT00636792|EG000|Reported Event|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
10915818|NCT00636805|BG000|Baseline|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
10915819|NCT00636805|FG000|Participant Flow|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
10915820|NCT00636805|OG000|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
10915821|NCT00636805|EG000|Reported Event|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
10915822|NCT00636818|BG000|Baseline|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
10915823|NCT00636818|FG000|Participant Flow|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
10915824|NCT00636818|OG000|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
10915825|NCT00636818|EG000|Reported Event|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
10915826|NCT00636961|BG000|Baseline|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
10915827|NCT00636961|BG001|Baseline|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
10915828|NCT00636961|BG002|Baseline|Total|Total of all reporting groups
10915829|NCT00636961|FG000|Participant Flow|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
10915830|NCT00636961|FG001|Participant Flow|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
10915831|NCT00636961|OG000|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
10915832|NCT00636961|OG001|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
10915833|NCT00636961|EG000|Reported Event|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
10915834|NCT00636961|EG001|Reported Event|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
10915835|NCT00636987|BG000|Baseline|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
10915836|NCT00636987|FG000|Participant Flow|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
10915837|NCT00636987|OG000|Outcome|Implanted With Biocor, Biocor Supra, Biocor Mitral Valves|Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
10915838|NCT00636987|OG000|Outcome|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
10915839|NCT00636987|OG000|Outcome|Biocor Valve|Biocor valves: Replacement for a diseased, damaged, malformed aortic heart valve
10915840|NCT00636987|OG001|Outcome|Biocor Supra Valve|
10915841|NCT00636987|OG002|Outcome|Biocor Mitral Valve|
10915842|NCT00636987|EG000|Reported Event|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
10915843|NCT00637000|BG000|Baseline|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
10915844|NCT00637000|BG001|Baseline|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
10915845|NCT00637000|BG002|Baseline|Total|Total of all reporting groups
10915846|NCT00637000|FG000|Participant Flow|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
10915847|NCT00637000|FG001|Participant Flow|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
10915848|NCT00637000|OG000|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
10915849|NCT00637000|OG001|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
10915850|NCT00637000|EG000|Reported Event|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
10915851|NCT00637000|EG001|Reported Event|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
10915852|NCT00637156|BG000|Baseline|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
10915853|NCT00637156|BG001|Baseline|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
10915854|NCT00637156|BG002|Baseline|Total|Total of all reporting groups
10915855|NCT00637156|FG000|Participant Flow|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
10915856|NCT00637156|FG001|Participant Flow|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
11357506|NCT03756506|EG000|Reported Event|DuraDerm® Group|"All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge.~Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal."
10915857|NCT00637156|OG000|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
10915858|NCT00637156|OG001|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
10915859|NCT00637156|EG000|Reported Event|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
10915860|NCT00637156|EG001|Reported Event|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
10915861|NCT00637195|BG000|Baseline|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
10915862|NCT00637195|BG001|Baseline|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
10915863|NCT00637195|BG002|Baseline|Total|Total of all reporting groups
10915864|NCT00637195|FG000|Participant Flow|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
10915865|NCT00637195|FG001|Participant Flow|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
10915866|NCT00637195|OG000|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
10915867|NCT00637195|OG001|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
10915868|NCT00637195|EG000|Reported Event|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
10915869|NCT00637195|EG001|Reported Event|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
10915870|NCT00637247|BG000|Baseline|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
10915871|NCT00637247|BG001|Baseline|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
10915872|NCT00637247|BG002|Baseline|Total|Total of all reporting groups
10915873|NCT00637247|FG000|Participant Flow|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
10915874|NCT00637247|FG001|Participant Flow|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
10915875|NCT00637247|OG000|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
10915876|NCT00637247|OG001|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
11174377|NCT02021565|OG001|Outcome|Delayed Intervention Control Group|"Control group.~Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
11174378|NCT02021565|EG000|Reported Event|Immediate Intervention Group - In-person|"Receives the in-home training intervention in-person immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
11174379|NCT02021565|EG001|Reported Event|Delayed Intervention Control Group - In-person|"Receives the in-home training intervention in-person six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
11174380|NCT02021565|EG002|Reported Event|Immediate Intervention Group - Tele Arm|"Receives the in-home training intervention remotely via a tele-video conference immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
11174381|NCT02021565|EG003|Reported Event|Delayed Intervention Control Group - Tele Arm|"Receives the in-home training intervention remotely via a tele-video conference six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
11174382|NCT02021643|BG000|Baseline|SOF+PEG+RBV 12 Weeks (GT 1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11174383|NCT02021643|BG001|Baseline|SOF+RBV 12 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11174384|NCT02021643|BG002|Baseline|SOF+RBV 16 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
11174385|NCT02021643|BG003|Baseline|SOF+RBV 24 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11174386|NCT02021643|BG004|Baseline|SOF+RBV 12 Weeks (GT2)|Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
10915877|NCT00637247|OG000|Outcome|Imexon + Gemcitabine|"imexon + gemcitabine~imexon in combination with gemcitabine: 875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV"
10915878|NCT00637247|OG001|Outcome|Placebo + Gemcitabine|"Placebo in combination with gemcitabine~imexon placebo + gemcitabine: imexon placebo IV + 1000 mg/m^2 gemcitabine IV"
10915879|NCT00637247|EG000|Reported Event|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
10915880|NCT00637247|EG001|Reported Event|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
10915881|NCT00637273|BG000|Baseline|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
10915882|NCT00637273|BG001|Baseline|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
10915883|NCT00637273|BG002|Baseline|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
10915884|NCT00637273|BG003|Baseline|Total|Total of all reporting groups
10915885|NCT00637273|FG000|Participant Flow|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
10915886|NCT00637273|FG001|Participant Flow|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
10915887|NCT00637273|FG002|Participant Flow|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
10915888|NCT00637273|OG000|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
10915889|NCT00637273|OG001|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
10915890|NCT00637273|OG002|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
10915891|NCT00637273|EG000|Reported Event|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
10915892|NCT00637273|EG001|Reported Event|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
10915893|NCT00637273|EG002|Reported Event|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
10915894|NCT00637299|BG000|Baseline|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
10915895|NCT00637299|BG001|Baseline|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
11174387|NCT02021643|BG005|Baseline|SOF+RBV 24 Weeks (GT3)|Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
10915896|NCT00637299|BG002|Baseline|Total|Total of all reporting groups
10915897|NCT00637299|FG000|Participant Flow|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
10915898|NCT00637299|FG001|Participant Flow|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
10915899|NCT00637299|OG000|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
10915900|NCT00637299|OG001|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
10915901|NCT00637299|EG000|Reported Event|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
10915902|NCT00637299|EG001|Reported Event|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
10915903|NCT00637377|BG000|Baseline|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915904|NCT00637377|BG001|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915905|NCT00637377|BG002|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915906|NCT00637377|BG003|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915907|NCT00637377|BG004|Baseline|Total|Total of all reporting groups
10915908|NCT00637377|FG000|Participant Flow|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915909|NCT00637377|FG001|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915910|NCT00637377|FG002|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915911|NCT00637377|FG003|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915912|NCT00637377|OG000|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915913|NCT00637377|OG001|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915914|NCT00637377|OG002|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10963133|NCT00870467|FG001|Participant Flow|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
11174388|NCT02021643|BG006|Baseline|Total|Total of all reporting groups
10915915|NCT00637377|OG003|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915916|NCT00637377|EG000|Reported Event|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915917|NCT00637377|EG001|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915918|NCT00637377|EG002|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915919|NCT00637377|EG003|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
10915920|NCT00637494|BG000|Baseline|Mifepristone Followed by an Antidepressant|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
10915921|NCT00637494|BG001|Baseline|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
10915922|NCT00637494|BG002|Baseline|Total|Total of all reporting groups
10915923|NCT00637494|FG000|Participant Flow|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
11174389|NCT02021643|FG000|Participant Flow|SOF+PEG+RBV 12 Weeks|Participants with genotype 1 or 6 received Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + Pegylated interferon alfa-2a (PEG) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
10915924|NCT00637494|FG001|Participant Flow|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
10915925|NCT00637494|OG000|Outcome|Active|"Mifepristone followed by an antidepressant~mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days"
10915926|NCT00637494|OG001|Outcome|Placebo|"Placebo followed by an antidepressant~placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days"
11174390|NCT02021643|FG001|Participant Flow|SOF+RBV 12 Weeks|Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
10915927|NCT00637494|EG000|Reported Event|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
10915928|NCT00637494|EG001|Reported Event|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
10915929|NCT00637572|BG000|Baseline|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per as single-dose for 12 weeks
10915930|NCT00637572|BG001|Baseline|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per as single-dose for 12 weeks
10915931|NCT00637572|BG002|Baseline|Total|Total of all reporting groups
10915932|NCT00637572|FG000|Participant Flow|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
10915933|NCT00637572|FG001|Participant Flow|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
11174391|NCT02021643|FG002|Participant Flow|SOF+RBV 16 Weeks|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
11174392|NCT02021643|FG003|Participant Flow|SOF+RBV 24 Weeks|Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
10915934|NCT00637572|OG000|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
10915935|NCT00637572|OG001|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
10915936|NCT00637572|EG000|Reported Event|Megestrol Acetate Oral Suspension NanoCrystal Dispersion|Subjects were treated with 575 mg per day as single dose for 12 weeks
10915937|NCT00637572|EG001|Reported Event|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single dose for 12 weeks
10915938|NCT00637780|BG000|Baseline|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
10915939|NCT00637780|FG000|Participant Flow|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
10915940|NCT00637780|OG000|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
10915941|NCT00637780|EG000|Reported Event|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
10915942|NCT00637923|BG000|Baseline|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
10915943|NCT00637923|BG001|Baseline|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
10915944|NCT00637923|BG002|Baseline|Total|Total of all reporting groups
10915945|NCT00637923|FG000|Participant Flow|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
10915946|NCT00637923|FG001|Participant Flow|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
10915947|NCT00637923|OG000|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
10915948|NCT00637923|OG001|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
10915949|NCT00637923|EG000|Reported Event|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
10915950|NCT00637923|EG001|Reported Event|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
11174393|NCT02021643|OG000|Outcome|SOF+PEG+RBV 12 Weeks (GT 1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
10915951|NCT00638014|BG000|Baseline|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
10915952|NCT00638014|BG001|Baseline|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
10915953|NCT00638014|BG002|Baseline|Total|Total of all reporting groups
10915954|NCT00638014|FG000|Participant Flow|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
10915955|NCT00638014|FG001|Participant Flow|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
11174394|NCT02021643|OG001|Outcome|SOF+RBV 12 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11174395|NCT02021643|OG002|Outcome|SOF+RBV 16 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
10915956|NCT00638014|OG000|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
10915957|NCT00638014|OG001|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
10915958|NCT00638014|EG000|Reported Event|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
10915959|NCT00638014|EG001|Reported Event|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
10915960|NCT00638027|BG000|Baseline|Memantine|Memantine 10 mg bid
10915961|NCT00638027|BG001|Baseline|Placebo|Placebo arm
10915962|NCT00638027|BG002|Baseline|Total|Total of all reporting groups
10915963|NCT00638027|FG000|Participant Flow|Memantine|Memantine 10 mg bid
10915964|NCT00638027|FG001|Participant Flow|Placebo|Placebo arm
10915965|NCT00638027|OG000|Outcome|Memantine|Memantine 10 mg bid
10915966|NCT00638027|OG001|Outcome|Placebo|Placebo arm
10915967|NCT00638027|EG000|Reported Event|Memantine|Memantine 10 mg bid
10915968|NCT00638027|EG001|Reported Event|Placebo|Placebo arm
10915969|NCT00638157|BG000|Baseline|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
10915970|NCT00638157|BG001|Baseline|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
10915971|NCT00638157|BG002|Baseline|Total|Total of all reporting groups
10915972|NCT00638157|FG000|Participant Flow|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
10915973|NCT00638157|FG001|Participant Flow|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
10915974|NCT00638157|OG000|Outcome|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
11174396|NCT02021643|OG003|Outcome|SOF+RBV 24 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11174397|NCT02021643|OG004|Outcome|SOF+RBV 12 Weeks (GT2)|Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11174398|NCT02021643|OG005|Outcome|SOF+RBV 24 Weeks (GT3)|Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11174399|NCT02021643|OG000|Outcome|SOF+PEG+RBV 12 Weeks|Participants with genotype (GT) 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11174400|NCT02021643|OG001|Outcome|SOF+RBV 12 Weeks|Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11174401|NCT02021643|OG002|Outcome|SOF+RBV 16 Weeks|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11174402|NCT02021643|OG003|Outcome|SOF+RBV 24 Weeks|Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11174403|NCT02021643|EG000|Reported Event|SOF+PEG+RBV 12 Weeks|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11174404|NCT02021643|EG001|Reported Event|SOF+RBV 12 Weeks|Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
10915975|NCT00638157|OG001|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
11174405|NCT02021643|EG002|Reported Event|SOF+RBV 16 Weeks|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
10915976|NCT00638157|OG000|Outcome|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
11174406|NCT02021643|EG003|Reported Event|SOF+RBV 24 Weeks|Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11174407|NCT02021656|BG000|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet administered once daily without regard to food for 12 weeks in treatment-experienced and treatment-naive participants in China, Korea, and Taiwan
11174408|NCT02021656|FG000|Participant Flow|LDV/SOF (Overall)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily administered without regard to food for 12 weeks in treatment-experienced and treatment-naive participants in China, Korea, and Taiwan
11174409|NCT02021656|OG000|Outcome|LDV/SOF: China|LDV/SOF (90/400 mg) FDC tablet administered once daily in treatment-experienced and treatment-naive participants in China without regard to food for 12 weeks
11174410|NCT02021656|OG001|Outcome|LDV/SOF: Overall|LDV/SOF (90/400 mg) FDC tablet administered once daily in treatment-experienced and treatment-naive participants in China, Korea, and Taiwan without regard to food for 12 weeks
10915977|NCT00638157|EG000|Reported Event|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
11174411|NCT02021656|OG000|Outcome|LDV/SOF: China|LDV/SOF (90/400 mg) FDC tablet administered once daily in treatment-experienced and treatment-naive participants in China without regard to food for 12 weeks.
11174412|NCT02021656|OG001|Outcome|LDF/SOF: Overall|LDV/SOF (90/400 mg) FDC tablet administered once daily in treatment-experienced and treatment-naive participants in Korea and Taiwan without regard to food for 12 weeks.
11174413|NCT02021656|OG001|Outcome|LDF/SOF: Overall|LDV/SOF (90/400 mg) FDC tablet administered once daily in treatment-experienced and treatment-naive participants in China, Korea, and Taiwan without regard to food for 12 weeks.
11174414|NCT02021656|EG000|Reported Event|LDV/SOF (Overall)|LDV/SOF (90/400 mg) FDC tablet administered once daily without regard to food for 12 weeks in treatment-experienced and treatment-naive participants in China, Korea, and Taiwan
11174415|NCT02021669|BG000|Baseline|Omega-3 Supplement|"Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks~Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks"
10915978|NCT00638157|EG001|Reported Event|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
10915979|NCT00638183|BG000|Baseline|Spiriva Treatment|Daily Therapy
11174416|NCT02021669|BG001|Baseline|Placebo|"Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.~Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks."
11174417|NCT02021669|BG002|Baseline|Total|Total of all reporting groups
11174418|NCT02021669|FG000|Participant Flow|Omega-3 Supplement|"Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks~Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks"
11174419|NCT02021669|FG001|Participant Flow|Placebo|"Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.~Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks."
11174420|NCT02021669|OG000|Outcome|Omega-3 Supplement|"Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks~Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks"
11174421|NCT02021669|OG001|Outcome|Placebo|"Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.~Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks."
11174422|NCT02021669|EG000|Reported Event|Omega-3 Supplement|"Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks~Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks"
11174423|NCT02021669|EG001|Reported Event|Placebo|"Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.~Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks."
10915980|NCT00638183|FG000|Participant Flow|Spiriva Treatment|Daily Therapy
10915981|NCT00638183|OG000|Outcome|Spiriva Treatment|Daily Therapy
10915982|NCT00638183|EG000|Reported Event|Spiriva Treatment|Daily Therapy
10915983|NCT00638235|BG000|Baseline|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
10915984|NCT00638235|BG001|Baseline|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
10915985|NCT00638235|BG002|Baseline|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse
10915986|NCT00638235|BG003|Baseline|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
10915987|NCT00638235|BG004|Baseline|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
10915988|NCT00638235|BG005|Baseline|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
10915989|NCT00638235|BG006|Baseline|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
10915990|NCT00638235|BG007|Baseline|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
10915991|NCT00638235|BG008|Baseline|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
10915992|NCT00638235|BG009|Baseline|Total|Total of all reporting groups
10915993|NCT00638235|FG000|Participant Flow|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
10915994|NCT00638235|FG001|Participant Flow|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
10915995|NCT00638235|FG002|Participant Flow|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
10915996|NCT00638235|FG003|Participant Flow|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
10915997|NCT00638235|FG004|Participant Flow|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
10915998|NCT00638235|FG005|Participant Flow|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
10915999|NCT00638235|FG006|Participant Flow|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
10916000|NCT00638235|FG007|Participant Flow|Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
10916001|NCT00638235|FG008|Participant Flow|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
10916002|NCT00638235|OG000|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
10916003|NCT00638235|OG001|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
10916004|NCT00638235|OG002|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
10916005|NCT00638235|OG003|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
10916006|NCT00638235|OG004|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
10916007|NCT00638235|OG005|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
10916008|NCT00638235|OG006|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
10916009|NCT00638235|OG007|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
11174428|NCT02021929|BG000|Baseline|Sorafenib|"400 mg (2 capsules) taken by mouth once a day~Sorafenib: Sorafenib is a kinase inhibitor indicated for the treatment of:~Unresectable hepatocellular carcinoma~Advanced renal cell carcinoma~Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment"
11174429|NCT02021929|BG001|Baseline|Placebo|"2 capsules taken by mouth once a day~Placebo"
11174430|NCT02021929|BG002|Baseline|Total|Total of all reporting groups
10916010|NCT00638235|OG008|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
10916011|NCT00638235|OG007|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
10916012|NCT00638235|OG002|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
10916013|NCT00638235|OG007|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
10916014|NCT00638235|OG002|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects had their 24M visit because next generation of Perigee was already under trial in Phase III/IV"
10916015|NCT00638235|OG006|Outcome|Phase V (Elevate Posterior InteXen LP, US & Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
10916016|NCT00638235|OG002|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IVmodels"
10916017|NCT00638235|OG007|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, Fot PROPEL Study Use Only)
10916018|NCT00638235|EG000|Reported Event|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
10916019|NCT00638235|EG001|Reported Event|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
10916020|NCT00638235|EG002|Reported Event|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
10916021|NCT00638235|EG003|Reported Event|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
10916022|NCT00638235|EG004|Reported Event|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
10916023|NCT00638235|EG005|Reported Event|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
10916024|NCT00638235|EG006|Reported Event|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
11191329|NCT02131662|EG004|Reported Event|Placebo|Subjects matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
10916025|NCT00638235|EG007|Reported Event|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
10916026|NCT00638235|EG008|Reported Event|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
10916027|NCT00638274|BG000|Baseline|1-AIR|"Air 3 ml used to identify epidural space~Air: 3 mls used for identifying epidural space"
10916028|NCT00638274|BG001|Baseline|2-SALINE|"Saline 3 ml used to identify epidural space~Saline: 3 mls of saline used to identify epidural space"
10916029|NCT00638274|BG002|Baseline|Total|Total of all reporting groups
10916030|NCT00638274|FG000|Participant Flow|1-AIR|"Air 3 ml used to identify epidural space~Air: 3 mls used for identifying epidural space"
10916031|NCT00638274|FG001|Participant Flow|2-SALINE|"Saline 3 ml used to identify epidural space~Saline: 3 mls of saline used to identify epidural space"
10916032|NCT00638274|OG000|Outcome|1-AIR|"Air 3 ml used to identify epidural space~Air: 3 mls used for identifying epidural space"
10916033|NCT00638274|OG001|Outcome|2-SALINE|"Saline 3 ml used to identify epidural space~Saline: 3 mls of saline used to identify epidural space"
10916034|NCT00638274|EG000|Reported Event|1-AIR|"Air 3 ml used to identify epidural space~Air: 3 mls used for identifying epidural space"
10916035|NCT00638274|EG001|Reported Event|2-SALINE|"Saline 3 ml used to identify epidural space~Saline: 3 mls of saline used to identify epidural space"
10916036|NCT00638365|BG000|Baseline|Placebo|
10916037|NCT00638365|BG001|Baseline|KB001, 3 mg/kg|
10916038|NCT00638365|BG002|Baseline|KB001, 10 mg/kg|
10916039|NCT00638365|BG003|Baseline|Total|Total of all reporting groups
10916040|NCT00638365|FG000|Participant Flow|Placebo|
10916041|NCT00638365|FG001|Participant Flow|KB001, 3 mg/kg|
10916042|NCT00638365|FG002|Participant Flow|KB001, 10 mg/kg|
10916043|NCT00638365|OG000|Outcome|Placebo|
10916044|NCT00638365|OG001|Outcome|KB001, 3 mg/kg|
10916045|NCT00638365|OG002|Outcome|KB001, 10 mg/kg|
11174431|NCT02021929|FG000|Participant Flow|Sorafenib|"400 mg (2 capsules) taken by mouth once a day~Sorafenib: Sorafenib is a kinase inhibitor indicated for the treatment of:~Unresectable hepatocellular carcinoma~Advanced renal cell carcinoma~Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment"
10916046|NCT00638365|EG000|Reported Event|Placebo|
10916047|NCT00638365|EG001|Reported Event|KB001, 3 mg/kg|
10916048|NCT00638365|EG002|Reported Event|KB001, 10 mg/kg|
10916049|NCT00638378|BG000|Baseline|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
10916050|NCT00638378|FG000|Participant Flow|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
10916051|NCT00638378|OG000|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
10916052|NCT00638378|EG000|Reported Event|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
10916053|NCT00638404|BG000|Baseline|1-elective Cesarean Sections|Elective Cesarean Sections-this portion completed
10916054|NCT00638404|BG001|Baseline|3-inpatient Gynecologic Procedures|Any in-patient gynecologic procedure- this portion completed
10916055|NCT00638404|BG002|Baseline|Total|Total of all reporting groups
10916056|NCT00638404|FG000|Participant Flow|1-elective Cesarean Section|Elective Cesarean Sections-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively
10916057|NCT00638404|FG001|Participant Flow|3-inpatient Gynecologic Procedures|Any in-patient gynecologic procedure-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively
10916058|NCT00638404|OG000|Outcome|1-elective Cesarean Section|Elective Cesarean Sections-evoked pain score at 24 hours postoperative 0-100mmVAS
10916059|NCT00638404|OG001|Outcome|3-inpatient Gynecologic Procedures|Any in-patient gynecologic procedure-
10916060|NCT00638404|OG000|Outcome|1-elective Cesarean Section|Elective Cesarean Sections-anticipated pain medication required postoperative evaluated during preoperative evaluation
10916061|NCT00638404|OG000|Outcome|1-elective Cesarean Section|Elective Cesarean Sections-anticipated pain postoperative obtained during preoperative evaluation
10916062|NCT00638404|OG000|Outcome|1-elective Cesarean Section|Elective Cesarean Sections preoperatively anxiety level
10916063|NCT00638404|OG001|Outcome|3-inpatient Gynecologic Procedures|Any in-patient gynecologic procedure-preoperative anxiety level on a scale of 0-not anxious at all up to 100=most anxious
10916064|NCT00638404|EG000|Reported Event|1-elective Cesarean Sections|Elective Cesarean Sections-this portion completed
10916065|NCT00638404|EG001|Reported Event|3-inpatient Gynecologic Procedures|Any in-patient gynecologic procedure- this portion completed
10916066|NCT00638443|BG000|Baseline|All Study Participants|"Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days~Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days"
11174432|NCT02021929|FG001|Participant Flow|Placebo|"2 capsules taken by mouth once a day~Placebo"
11357507|NCT03756506|EG001|Reported Event|Control Group: no DuraDerm|"The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.~Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.~Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris."
11357508|NCT03756285|BG000|Baseline|AZD4831|AZD4831 tablets taken orally for for 90 days.
11357509|NCT03756285|BG001|Baseline|Placebo|Placebo tablets taken orally for 90 days.
11357510|NCT03756285|BG002|Baseline|Total|Total of all reporting groups
11357511|NCT03756285|FG000|Participant Flow|AZD4831|AZD4831 tablets taken orally for for 90 days.
11357512|NCT03756285|FG001|Participant Flow|Placebo|Placebo tablets taken orally for 90 days.
11357513|NCT03756285|OG000|Outcome|AZD4831|AZD4831 tablets taken orally for 90 days.
11357514|NCT03756285|OG001|Outcome|Placebo|Placebo tablets taken orally for 90 days.
11357515|NCT03756285|OG000|Outcome|AZD4831|AZD4831 tablets taken orally for for 90 days.
11357516|NCT03756285|EG000|Reported Event|AZD4831|AZD4831 tablets taken orally for for 90 days.
11357517|NCT03756285|EG001|Reported Event|Placebo|Placebo tablets taken orally for 90 days.
11357518|NCT03756129|BG000|Baseline|MIJ821 0.16 mg/kg Weekly|MIJ821 0.16 mg/kg weekly
11357519|NCT03756129|BG001|Baseline|MIJ821 0.16 mg/kg Biweekly|MIJ821 0.16 mg/kg biweekly
11357520|NCT03756129|BG002|Baseline|MIJ821 0.32 mg/kg Weekly|MIJ821 0.32 mg/kg weekly
11357521|NCT03756129|BG003|Baseline|MIJ821 0.32 mg/kg Biweekly|MIJ821 0.32 mg/kg biweekly
11357522|NCT03756129|BG004|Baseline|Ketamine 0.5 mg/kg Weekly|Ketamine 0.5 mg/kg weekly
11357523|NCT03756129|BG005|Baseline|Placebo Weekly|Placebo weekly
11357524|NCT03756129|BG006|Baseline|Total|Total of all reporting groups
11357525|NCT03756129|FG000|Participant Flow|MIJ821 0.16 mg/kg Weekly|MIJ821 0.16 mg/kg weekly
11357526|NCT03756129|FG001|Participant Flow|MIJ821 0.16 mg/kg Biweekly|MIJ821 0.16 mg/kg biweekly
11357527|NCT03756129|FG002|Participant Flow|MIJ821 0.32 mg/kg Weekly|MIJ821 0.32 mg/kg weekly
11357528|NCT03756129|FG003|Participant Flow|MIJ821 0.32 mg/kg Biweekly|MIJ821 0.32 mg/kg biweekly
11357529|NCT03756129|FG004|Participant Flow|Ketamine 0.5 mg/kg Weekly|Ketamine 0.5 mg/kg weekly
11357530|NCT03756129|FG005|Participant Flow|Placebo Weekly|Placebo weekly
11357531|NCT03756129|OG000|Outcome|Pooled MIJ821 0.16 mg/kg|Pooled MIJ821 0.16 mg/kg
11357532|NCT03756129|OG001|Outcome|Pooled MIJ821 0.32 mg/kg|Pooled MIJ821 0.32 mg/kg
11357533|NCT03756129|OG002|Outcome|Ketamine 0.5 mg/kg Weekly|Ketamine 0.5 mg/kg weekly
11357534|NCT03756129|OG003|Outcome|Placebo Weekly|Placebo weekly
11357535|NCT03756129|OG000|Outcome|MIJ821 0.16 mg/kg Weekly|MIJ821 0.16 mg/kg weekly
11357536|NCT03756129|OG001|Outcome|MIJ821 0.16 mg/kg Biweekly|MIJ821 0.16 mg/kg biweekly
11357537|NCT03756129|OG002|Outcome|MIJ821 0.32 mg/kg Weekly|MIJ821 0.32 mg/kg weekly
11357538|NCT03756129|OG003|Outcome|MIJ821 0.32 mg/kg Biweekly|MIJ821 0.32 mg/kg biweekly
11357539|NCT03756129|OG004|Outcome|Ketamine 0.5 mg/kg Weekly|Ketamine 0.5 mg/kg weekly
11357540|NCT03756129|OG005|Outcome|Placebo Weekly|Placebo weekly
11357541|NCT03756129|OG000|Outcome|Koukopoulos|Koukopoulos Mixed Depression Rating Scale
11357542|NCT03756129|OG001|Outcome|Angst|Mixed depression checklist, created by Angst
11357543|NCT03756129|OG002|Outcome|Ghaemi|Melancholia checklist, created by Ghaemi
11357544|NCT03756129|EG000|Reported Event|MIJ821 0.16 mg/kg Weekly*|MIJ821 0.16 mg/kg weekly*
11357545|NCT03756129|EG001|Reported Event|MIJ821 0.16 mg/kg Every Other Week|MIJ821 0.16 mg/kg every other week
11357546|NCT03756129|EG002|Reported Event|MIJ821 0.32 mg/kg Weekly|MIJ821 0.32 mg/kg weekly
11357547|NCT03756129|EG003|Reported Event|MIJ821 0.32 mg/kg Every Other Week|MIJ821 0.32 mg/kg every other week
11357548|NCT03756129|EG004|Reported Event|Ketamine 0.5 mg/kg Weekly|Ketamine 0.5 mg/kg weekly
11357549|NCT03756129|EG005|Reported Event|Placebo Weekly|Placebo weekly
11357550|NCT03756129|EG006|Reported Event|Total|Total
11357551|NCT03756038|BG000|Baseline|Drug: Oral Lorazepam (1mg)|"Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.~Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment."
11357552|NCT03756038|BG001|Baseline|Drug: Oral Placebo|Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
11357553|NCT03756038|BG002|Baseline|Total|Total of all reporting groups
11357554|NCT03756038|FG000|Participant Flow|Drug: Oral Lorazepam (1mg)|"Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.~Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment."
11357555|NCT03756038|FG001|Participant Flow|Drug: Oral Placebo|Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
11357556|NCT03756038|OG000|Outcome|Drug: Oral Lorazepam (1mg)|"Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.~Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment."
11357557|NCT03756038|OG001|Outcome|Drug: Oral Placebo|Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
10916067|NCT00638443|FG000|Participant Flow|Pregabalin First, Diphenhydramine Second|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days; washout 7 days; Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
10916068|NCT00638443|FG001|Participant Flow|Diphenhydramine First, Pregabalin Second|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days; washout 7 days; Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
10916069|NCT00638443|OG000|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
10916070|NCT00638443|OG001|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
10916071|NCT00638443|OG000|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
10916072|NCT00638443|OG001|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
10916073|NCT00638443|EG000|Reported Event|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
10916074|NCT00638443|EG001|Reported Event|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
10916075|NCT00638456|BG000|Baseline|Oral Viscous Budesonide Plus Prevacid|Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
10916076|NCT00638456|BG001|Baseline|Placebo Plus Prevacid|placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
10916077|NCT00638456|BG002|Baseline|Total|Total of all reporting groups
10916078|NCT00638456|FG000|Participant Flow|Oral Viscous Budesonide Plus Prevacid|Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
10916079|NCT00638456|FG001|Participant Flow|Placebo Plus Prevacid|placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
10916080|NCT00638456|OG000|Outcome|Oral Viscous Budesonide Plus Prevacid|Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
10916081|NCT00638456|OG001|Outcome|Placebo Plus Prevacid|placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
10916082|NCT00638456|EG000|Reported Event|Oral Viscous Budesonide Plus Prevacid|Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
10916083|NCT00638456|EG001|Reported Event|Placebo Plus Prevacid|placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
10916084|NCT00638508|BG000|Baseline|Ketorolac|Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
10916085|NCT00638508|BG001|Baseline|Ketorolac With Ropivacaine|Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site.
10916086|NCT00638508|BG002|Baseline|Total|Total of all reporting groups
10916087|NCT00638508|FG000|Participant Flow|Ketorolac|Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
10916088|NCT00638508|FG001|Participant Flow|Ketorolac With Rpopivacaine|Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% via an infusion catheter at the incision siteKetorolac and Ropivacaine
10916089|NCT00638508|OG000|Outcome|Ketorolac|Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
10916090|NCT00638508|OG001|Outcome|Ketorolac With Ropivacaine|Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
10916091|NCT00638508|OG000|Outcome|Ketorolac|"Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day~Ketorolac: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day"
10916092|NCT00638508|OG001|Outcome|Ketorolac With Ropivacaine|Patients will receive Ketorolac 5 mg/hour and Ropivacaine 0.5% via an infusion catheter at the incision site
10916093|NCT00638508|OG001|Outcome|Ketorolac With Ropivacaine|Patients will receive Ketorolac and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site
10916094|NCT00638508|OG001|Outcome|Ketorolac With Ropivacaine|Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site.
10916095|NCT00638508|EG000|Reported Event|Ketorolac|Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
10916096|NCT00638508|EG001|Reported Event|Ketorolac and Ropivacainr|Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site.
10916097|NCT00638651|BG000|Baseline|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
10916098|NCT00638651|FG000|Participant Flow|Laser Treatment With Imiquimod Cream or Placebo|Participants with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
10916099|NCT00638651|OG000|Outcome|Laser Treatment With Imiquimod (Group 1)|"The tattoo will be treated with laser and imiquimod 5% cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy~Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month"
10916100|NCT00638651|OG001|Outcome|Laser Treatment With Placebo Cream (Group 2)|"The tattoo will be treated with laser and placebo topical cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy"
10916101|NCT00638651|EG000|Reported Event|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
10916102|NCT00638690|BG000|Baseline|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
10916103|NCT00638690|BG001|Baseline|Placebo|Placebo plus prednisone/prednisolone
10916104|NCT00638690|BG002|Baseline|Total|Total of all reporting groups
10916105|NCT00638690|FG000|Participant Flow|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
10916106|NCT00638690|FG001|Participant Flow|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
10916107|NCT00638690|OG000|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
10916108|NCT00638690|OG001|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
10916109|NCT00638690|EG000|Reported Event|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
10916110|NCT00638690|EG001|Reported Event|Placebo|Placebo plus prednisone/prednisolone
10916111|NCT00638690|EG002|Reported Event|Placebo to Abiraterone Acetate|Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
10916112|NCT00638716|BG000|Baseline|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
10916113|NCT00638716|BG001|Baseline|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
10916114|NCT00638716|BG002|Baseline|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
10916115|NCT00638716|BG003|Baseline|Total|Total of all reporting groups
10916116|NCT00638716|FG000|Participant Flow|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
10916117|NCT00638716|FG001|Participant Flow|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
10916118|NCT00638716|FG002|Participant Flow|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
10916119|NCT00638716|OG000|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
10916120|NCT00638716|OG001|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
10916121|NCT00638716|OG002|Outcome|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
10916122|NCT00638716|EG000|Reported Event|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
10916123|NCT00638716|EG001|Reported Event|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
10916124|NCT00638716|EG002|Reported Event|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
10916125|NCT00638820|BG000|Baseline|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
10916126|NCT00638820|FG000|Participant Flow|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
10916127|NCT00638820|OG000|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
10916128|NCT00638820|EG000|Reported Event|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
10916129|NCT00638846|BG000|Baseline|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
10916130|NCT00638846|BG001|Baseline|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
10916131|NCT00638846|BG002|Baseline|Total|Total of all reporting groups
10916132|NCT00638846|FG000|Participant Flow|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
10916133|NCT00638846|FG001|Participant Flow|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
10916134|NCT00638846|OG000|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
10916135|NCT00638846|OG001|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
10916136|NCT00638846|EG000|Reported Event|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
10916137|NCT00638846|EG001|Reported Event|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
10916138|NCT00638885|BG000|Baseline|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
10916139|NCT00638885|FG000|Participant Flow|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
10916140|NCT00638885|OG000|Outcome|Vietnam Veteran Twins|Vietnam veteran twins with and without PTSD.
10916141|NCT00638885|EG000|Reported Event|Vietnam Twins With and Without PTSD|
10916142|NCT00638924|BG000|Baseline|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
10916143|NCT00638924|FG000|Participant Flow|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
10916144|NCT00638924|OG000|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
10916145|NCT00638924|EG000|Reported Event|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
10916146|NCT00638937|BG000|Baseline|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
10916147|NCT00638937|FG000|Participant Flow|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: 175mg given PO daily~laboratory biomarker analysis: Correlative studies"
10916148|NCT00638937|OG000|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
10916149|NCT00638937|OG000|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
10916150|NCT00638937|OG000|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: 175mg given PO daily~laboratory biomarker analysis: Correlative studies"
10916151|NCT00638937|EG000|Reported Event|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
10916152|NCT00638963|BG000|Baseline|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
10916153|NCT00638963|BG001|Baseline|Observational|No temozolomide treatment
10916154|NCT00638963|BG002|Baseline|Total|Total of all reporting groups
10916155|NCT00638963|FG000|Participant Flow|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
10916156|NCT00638963|FG001|Participant Flow|Observational|No temozolomide treatment
10916157|NCT00638963|OG000|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
10916158|NCT00638963|OG001|Outcome|Observational|No temozolomide treatment
11174433|NCT02021929|OG000|Outcome|Sorafenib|"400 mg (2 capsules) taken by mouth once a day~Sorafenib: Sorafenib is a kinase inhibitor indicated for the treatment of:~Unresectable hepatocellular carcinoma~Advanced renal cell carcinoma~Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment"
10916159|NCT00638963|EG000|Reported Event|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
10916160|NCT00638963|EG001|Reported Event|Observational|No temozolomide treatment
10916161|NCT00638989|BG000|Baseline|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
10916162|NCT00638989|BG001|Baseline|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
10916163|NCT00638989|BG002|Baseline|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
11174434|NCT02021929|OG001|Outcome|Placebo|"2 capsules taken by mouth once a day~Placebo"
10916164|NCT00638989|BG003|Baseline|Total|Total of all reporting groups
10916165|NCT00638989|FG000|Participant Flow|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
10916166|NCT00638989|FG001|Participant Flow|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
10916167|NCT00638989|FG002|Participant Flow|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
10916168|NCT00638989|OG000|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
10916169|NCT00638989|OG001|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
10916170|NCT00638989|OG000|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
10916171|NCT00638989|OG001|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
10916172|NCT00638989|OG002|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
10916173|NCT00638989|EG000|Reported Event|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
10916174|NCT00638989|EG001|Reported Event|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
10916175|NCT00638989|EG002|Reported Event|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
10916176|NCT00639002|BG000|Baseline|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
10916177|NCT00639002|FG000|Participant Flow|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
10916178|NCT00639002|OG000|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
10916179|NCT00639002|EG000|Reported Event|Ruxolitinib|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days until the following criteria were met: Disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent.
10916180|NCT00639002|EG001|Reported Event|Ruxolitinib + Dexamethasone|Following administration of ruxolitinib 25 mg bid alone, for those patients who had disease progression at any time, stable disease for 3 cycles, did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
10916181|NCT00639093|BG000|Baseline|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
10916182|NCT00639093|BG001|Baseline|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
10916183|NCT00639093|BG002|Baseline|Total|Total of all reporting groups
10916184|NCT00639093|FG000|Participant Flow|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
10916185|NCT00639093|FG001|Participant Flow|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
10916186|NCT00639093|OG000|Outcome|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
10916187|NCT00639093|OG001|Outcome|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
11174435|NCT02021929|EG000|Reported Event|Sorafenib|"400 mg (2 capsules) taken by mouth once a day~Sorafenib: Sorafenib is a kinase inhibitor indicated for the treatment of:~Unresectable hepatocellular carcinoma~Advanced renal cell carcinoma~Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment"
11174436|NCT02021929|EG001|Reported Event|Placebo|"2 capsules taken by mouth once a day~Placebo"
11174437|NCT02021942|BG000|Baseline|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
10916188|NCT00639093|EG000|Reported Event|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
10916189|NCT00639093|EG001|Reported Event|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
10916190|NCT00639158|BG000|Baseline|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
10916191|NCT00639158|BG001|Baseline|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
10916192|NCT00639158|BG002|Baseline|Total|Total of all reporting groups
10916193|NCT00639158|FG000|Participant Flow|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
11174438|NCT02021942|FG000|Participant Flow|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
11174439|NCT02021942|OG000|Outcome|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
11174440|NCT02021942|EG000|Reported Event|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
11174441|NCT02021955|BG000|Baseline|Provider Participants|all primary care providers: demographic information not collected
11174442|NCT02021955|BG001|Baseline|Control Patient Participants|data for all patients discharged under care of a provider in the control group
10916194|NCT00639158|FG001|Participant Flow|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
11174443|NCT02021955|BG002|Baseline|Intervention Patient Participants|data for all patients discharged under care of a provider in the intervention group
10916195|NCT00639158|OG000|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
11174444|NCT02021955|BG003|Baseline|Total|Total of all reporting groups
11174445|NCT02021955|FG000|Participant Flow|Usual Care|Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
10916196|NCT00639158|OG001|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
10916197|NCT00639158|EG000|Reported Event|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
10916198|NCT00639158|EG001|Reported Event|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
10916199|NCT00639223|BG000|Baseline|Pravastatin|
10916200|NCT00639223|BG001|Baseline|Red Yeast Rice|
10916201|NCT00639223|BG002|Baseline|Total|Total of all reporting groups
11357558|NCT03756038|EG000|Reported Event|Drug: Oral Lorazepam (1mg)|"Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.~Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment."
10916202|NCT00639223|FG000|Participant Flow|Pravastatin|
10916203|NCT00639223|FG001|Participant Flow|Red Yeast Rice|
11357559|NCT03756038|EG001|Reported Event|Drug: Oral Placebo|Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
11357560|NCT03756012|BG000|Baseline|Total Patient Population|"This was a case series and all patients received both algorithms; pulse widths <500 µsec and >1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.~Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
10916204|NCT00639223|OG000|Outcome|Pravastatin|
10916205|NCT00639223|OG001|Outcome|Red Yeast Rice|
10916206|NCT00639223|EG000|Reported Event|Pravastatin|
10916207|NCT00639223|EG001|Reported Event|Red Yeast Rice|
10916208|NCT00639379|BG000|Baseline|Total Completed Participants|
10916209|NCT00639379|FG000|Participant Flow|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
10916210|NCT00639379|FG001|Participant Flow|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
10916211|NCT00639379|OG000|Outcome|Senofilcon A Toric|
10916212|NCT00639379|OG001|Outcome|Alphafilcon A Toric|
10916213|NCT00639379|EG000|Reported Event|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
10916214|NCT00639379|EG001|Reported Event|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
10916215|NCT00639418|BG000|Baseline|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age
10916216|NCT00639418|BG001|Baseline|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age
10916217|NCT00639418|BG002|Baseline|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age
10916218|NCT00639418|BG003|Baseline|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
10916219|NCT00639418|BG004|Baseline|Total|Total of all reporting groups
10916220|NCT00639418|FG000|Participant Flow|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age
10916221|NCT00639418|FG001|Participant Flow|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age
10916222|NCT00639418|FG002|Participant Flow|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age
10916223|NCT00639418|FG003|Participant Flow|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
10916224|NCT00639418|OG000|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age
10916225|NCT00639418|OG001|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age
10916226|NCT00639418|OG002|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age
10916227|NCT00639418|OG003|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
10916228|NCT00639418|OG000|Outcome|Staff Attitudes: High-risk Medical Conditions|Number of sites that agreed or somewhat agreed that they strongly recommend seasonal influenza vaccination to patients 5 to 18 years of age with high-risk medical conditions
10916229|NCT00639418|OG001|Outcome|Staff Attitudes: 6 Months to 5 Year Old Patients|Number of sites that strongly recommend that patients 6 months to 5 years of age be vaccinated against influenza each year.
10916230|NCT00639418|OG002|Outcome|Staff Attitudes: 5 to 18 Year Old Patients|Number of sites that agreed or somewhat agreed that they strongly recommend that patients 5 to 18 years of age without high-risk medical conditions be vaccinated against influenza each year
10916231|NCT00639418|OG003|Outcome|Staff Attitudes: Number of Doses|Number of sites that agreed or somewhat agreed that they strongly recommend that previously unvaccinated patients less than 9 years of age receive 2 doses of influenza vaccine
10916232|NCT00639418|EG000|Reported Event|Children 6 to 23 Months|AEs were not collected in this observational study of physician vaccination practices.
10916233|NCT00639418|EG001|Reported Event|Children 24 to 59 Months|AEs were not collected in this observational study of physician vaccination practices.
10916234|NCT00639418|EG002|Reported Event|Children 5 to 8 Years|AEs were not collected in this observational study of physician vaccination practices.
10916235|NCT00639418|EG003|Reported Event|Children 9 to 18 Years|AEs were not collected in this observational study of physician vaccination practices.
10916236|NCT00639457|BG000|Baseline|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
10916237|NCT00639457|BG001|Baseline|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
10916238|NCT00639457|BG002|Baseline|Total|Total of all reporting groups
10916239|NCT00639457|FG000|Participant Flow|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
10916240|NCT00639457|FG001|Participant Flow|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
10916241|NCT00639457|OG000|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
10916242|NCT00639457|OG001|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
10916243|NCT00639457|EG000|Reported Event|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
10916244|NCT00639457|EG001|Reported Event|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
10916245|NCT00639509|BG000|Baseline|IMC-A12|Participants will receive IMC-A12 at a dose of 6mg/kg IV over 1 hour on Day 1 every week.
10916246|NCT00639509|FG000|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
10916247|NCT00639509|OG000|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
10916248|NCT00639509|EG000|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
10916249|NCT00639678|BG000|Baseline|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
10916250|NCT00639678|BG001|Baseline|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
10916251|NCT00639678|BG002|Baseline|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916252|NCT00639678|BG003|Baseline|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916253|NCT00639678|BG004|Baseline|Total|Total of all reporting groups
10916254|NCT00639678|FG000|Participant Flow|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
10916255|NCT00639678|FG001|Participant Flow|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
10916256|NCT00639678|FG002|Participant Flow|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916257|NCT00639678|FG003|Participant Flow|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916258|NCT00639678|OG000|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
10916259|NCT00639678|OG001|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
10916260|NCT00639678|OG002|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916261|NCT00639678|OG003|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916262|NCT00639678|OG000|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916263|NCT00639678|OG000|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916264|NCT00639678|EG000|Reported Event|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
10916265|NCT00639678|EG001|Reported Event|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
10916266|NCT00639678|EG002|Reported Event|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916267|NCT00639678|EG003|Reported Event|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
10916268|NCT00639717|BG000|Baseline|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
10916269|NCT00639717|FG000|Participant Flow|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
10916270|NCT00639717|OG000|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
10916271|NCT00639717|EG000|Reported Event|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
10916272|NCT00639769|BG000|Baseline|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
10916273|NCT00639769|FG000|Participant Flow|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
10916274|NCT00639769|OG000|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
11174446|NCT02021955|FG001|Participant Flow|Guideline Treatment Recommendations|"Primary care clinicians receive treatment recommendations for their patients discharged from hospital for a COPD exacerbation.~guideline treatment recommendations: Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation."
11174447|NCT02021955|OG000|Outcome|Usual Care|Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
11174448|NCT02021955|OG001|Outcome|Guideline Treatment Recommendations|Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
10916275|NCT00639769|EG000|Reported Event|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
11174449|NCT02021955|EG000|Reported Event|Usual Care|Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
10916276|NCT00639860|BG000|Baseline|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
10916277|NCT00639860|FG000|Participant Flow|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
10916278|NCT00639860|OG000|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
10916279|NCT00639860|EG000|Reported Event|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
10916280|NCT00640016|BG000|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916281|NCT00640016|BG001|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916282|NCT00640016|BG002|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916283|NCT00640016|BG003|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916284|NCT00640016|BG004|Baseline|Total|Total of all reporting groups
10916285|NCT00640016|FG000|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916286|NCT00640016|FG001|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916287|NCT00640016|FG002|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916288|NCT00640016|FG003|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916289|NCT00640016|OG000|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916290|NCT00640016|OG001|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916291|NCT00640016|OG000|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916292|NCT00640016|OG001|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916293|NCT00640016|OG002|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916294|NCT00640016|OG002|Outcome|CAT-354 10 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916295|NCT00640016|OG000|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916296|NCT00640016|OG000|Outcome|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916297|NCT00640016|OG001|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916298|NCT00640016|OG002|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916299|NCT00640016|OG003|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916300|NCT00640016|EG000|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56
10916301|NCT00640016|EG001|Reported Event|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916302|NCT00640016|EG002|Reported Event|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916303|NCT00640016|EG003|Reported Event|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
10916304|NCT00640042|BG000|Baseline|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
10916305|NCT00640042|FG000|Participant Flow|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
10916306|NCT00640042|OG000|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
11174450|NCT02021955|EG001|Reported Event|Guideline Treatment Recommendations|Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
11174451|NCT02022007|BG000|Baseline|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
10916307|NCT00640042|EG000|Reported Event|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
10916308|NCT00640146|BG000|Baseline|MNTX|Participants received MNTX 12 mg SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.
10916309|NCT00640146|BG001|Baseline|Placebo|Participants received placebo matched to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.
10916310|NCT00640146|BG002|Baseline|Total|Total of all reporting groups
10916311|NCT00640146|FG000|Participant Flow|MNTX|Participants received methylnaltrexone (MNTX) 12 milligrams (mg) subcutaneously (SC) once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.
10916312|NCT00640146|FG001|Participant Flow|Placebo|Participants received placebo matched to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.
10916313|NCT00640146|OG000|Outcome|MNTX|Participants received MNTX 12 mg SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.
10916314|NCT00640146|OG001|Outcome|Placebo|Participants received placebo matched to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.
10916315|NCT00640146|EG000|Reported Event|MNTX|Participants received MNTX 12 mg SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.
10916316|NCT00640146|EG001|Reported Event|Placebo|Participants received placebo matched to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.
10916317|NCT00640224|BG000|Baseline|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
10916318|NCT00640224|BG001|Baseline|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
10916319|NCT00640224|BG002|Baseline|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
10916320|NCT00640224|BG003|Baseline|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
10916321|NCT00640224|BG004|Baseline|Total|Total of all reporting groups
10916322|NCT00640224|FG000|Participant Flow|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
10916323|NCT00640224|FG001|Participant Flow|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
10916324|NCT00640224|FG002|Participant Flow|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
10916325|NCT00640224|FG003|Participant Flow|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
10916326|NCT00640224|OG000|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
10916327|NCT00640224|OG001|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
10916328|NCT00640224|OG002|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
10916329|NCT00640224|OG003|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
11174452|NCT02022007|BG001|Baseline|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
10916330|NCT00640224|EG000|Reported Event|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
10916331|NCT00640224|EG001|Reported Event|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
10916332|NCT00640224|EG002|Reported Event|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
10916333|NCT00640224|EG003|Reported Event|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
10916334|NCT00640250|BG000|Baseline|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.
10916335|NCT00640250|FG000|Participant Flow|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.
10916336|NCT00640250|OG000|Outcome|Disperse Blue 0.017 mg/cm2|Percentage of positive test responses
10916337|NCT00640250|OG001|Outcome|Disperse Blue 0.050 mg/cm2|Percentage of positive test responses
11174453|NCT02022007|BG002|Baseline|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
11174454|NCT02022007|BG003|Baseline|Total|Total of all reporting groups
11174455|NCT02022007|FG000|Participant Flow|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
10916338|NCT00640250|OG002|Outcome|Disperse Blue 0.150 mg/cm2|Percentage of positive test responses
10916339|NCT00640250|OG003|Outcome|Bronopol 0.125 mg/cm2|Percentage of positive test responses
10916340|NCT00640250|OG004|Outcome|Bronopol 0.250 mg/cm2|Percentage of positive test responses
10916341|NCT00640250|OG005|Outcome|Bronopol 0.500 mg/cm2|Percentage of positive test responses
10916342|NCT00640250|OG006|Outcome|Bronopol 0.750 mg/cm2|Percentage of positive test responses
10916343|NCT00640250|OG000|Outcome|Disperse Blue 0.017 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
10916344|NCT00640250|OG001|Outcome|Disperse Blue 0.050 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
10916345|NCT00640250|OG002|Outcome|Disperse Blue 0.150 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
10916346|NCT00640250|OG003|Outcome|Negative Control Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
10916347|NCT00640250|OG004|Outcome|Disperse Blue 0.017 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
10916348|NCT00640250|OG005|Outcome|Disperse Blue 0.050 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
10916349|NCT00640250|OG006|Outcome|Disperse Blue 0.150 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
10916350|NCT00640250|OG007|Outcome|Negative Control Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
10916351|NCT00640250|OG008|Outcome|Disperse Blue 0.017 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
10916352|NCT00640250|OG009|Outcome|Disperse Blue 0.050 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
10916353|NCT00640250|OG010|Outcome|Disperse Blue 0.150 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
10916354|NCT00640250|OG011|Outcome|Negative Control Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
10916355|NCT00640250|OG012|Outcome|Disperse Blue 0.017 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
10916356|NCT00640250|OG013|Outcome|Disperse Blue 0.050 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
10916357|NCT00640250|OG014|Outcome|Disperse Blue 0.150 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
10916358|NCT00640250|OG015|Outcome|Negative Control Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
10916359|NCT00640250|OG000|Outcome|Disperse Blue 0.017 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
10916360|NCT00640250|OG001|Outcome|Disperse Blue 0.050 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
10916361|NCT00640250|OG002|Outcome|Disperse Blue 0.150 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
10916362|NCT00640250|OG003|Outcome|Negative Control Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
10916363|NCT00640250|OG004|Outcome|Disperse Blue 0.017 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
10916364|NCT00640250|OG005|Outcome|Disperse Blue 0.050 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
10916365|NCT00640250|OG006|Outcome|Disperse Blue 0.150 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
10916366|NCT00640250|OG007|Outcome|Negative Control Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
10916367|NCT00640250|OG008|Outcome|Disperse Blue 0.017 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
10916368|NCT00640250|OG009|Outcome|Disperse Blue 0.050 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
10916369|NCT00640250|OG010|Outcome|Disperse Blue 0.150 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
10916370|NCT00640250|OG011|Outcome|Negative Control Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
10916371|NCT00640250|OG012|Outcome|Disperse Blue 0.017 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
10916372|NCT00640250|OG013|Outcome|Disperse Blue 0.050 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
10916373|NCT00640250|OG014|Outcome|Disperse Blue 0.150 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
10916374|NCT00640250|OG015|Outcome|Negative Control Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
10916375|NCT00640250|OG000|Outcome|Bronopol 0.1 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
10916376|NCT00640250|OG001|Outcome|Bronopol 0.250 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
10916377|NCT00640250|OG002|Outcome|Bronopol 0.500 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
10916378|NCT00640250|OG003|Outcome|Bronopol 0.750 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
10916379|NCT00640250|OG004|Outcome|Bronopol 0.1 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
10916380|NCT00640250|OG005|Outcome|Bronopol 0.250 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
10916381|NCT00640250|OG006|Outcome|Bronopol 0.500 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
10916382|NCT00640250|OG007|Outcome|Bronopol 0.750 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
10916383|NCT00640250|OG008|Outcome|Bronopol 0.1 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
10916384|NCT00640250|OG009|Outcome|Bronopol 0.250 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
10916385|NCT00640250|OG010|Outcome|Bronopol 0.500 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
10916386|NCT00640250|OG011|Outcome|Bronopol 0.750 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
10916387|NCT00640250|OG012|Outcome|Bronopol 0.1 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
10916388|NCT00640250|OG013|Outcome|Bronopol 0.250 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
10916389|NCT00640250|OG014|Outcome|Bronopol 0.500 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
10916390|NCT00640250|OG015|Outcome|Bronopol 0.750 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
10916391|NCT00640250|OG000|Outcome|Bronopol 0.125 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
10916392|NCT00640250|OG001|Outcome|Bronopol 0.250 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
10916393|NCT00640250|OG002|Outcome|Bronopol 0.500 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
10916394|NCT00640250|OG003|Outcome|Bronopol 0.750 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
10916395|NCT00640250|OG004|Outcome|Bronopol 0.125 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
10916396|NCT00640250|OG005|Outcome|Bronopol 0.250 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
10916397|NCT00640250|OG006|Outcome|Bronopol 0.500 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
10916398|NCT00640250|OG007|Outcome|Bronopol 0.750 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
10916399|NCT00640250|OG008|Outcome|Bronopol 0.125 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
10916400|NCT00640250|OG009|Outcome|Bronopol 0.250 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
10916401|NCT00640250|OG010|Outcome|Bronopol 0.500 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
10916402|NCT00640250|OG011|Outcome|Bronopol 0.750 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
10916403|NCT00640250|OG012|Outcome|Bronopol 0.125 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
10916404|NCT00640250|OG013|Outcome|Bronopol 0.250 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
10916405|NCT00640250|OG014|Outcome|Bronopol 0.500 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
10916406|NCT00640250|OG015|Outcome|Bronopol 0.750 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
10916407|NCT00640250|OG000|Outcome|Disperse Blue 0.017 mg/cm2|Concordance between disperse blue and the reference petrolatum allergen
10916408|NCT00640250|OG001|Outcome|Disperse Blue 0.050 mg/cm2|Concordance between disperse blue and the reference petrolatum allergen
10916409|NCT00640250|OG002|Outcome|Disperse Blue 0.150 mg/cm2|Concordance between disperse blue and the reference petrolatum allergen
10916410|NCT00640250|OG003|Outcome|Bronopol 0.125 mg/cm2|Concordance between bronopol and the reference petrolatum allergen
10916411|NCT00640250|OG004|Outcome|Bronopol 0.250 mg/cm2|Concordance between bronopol and the reference petrolatum allergen
10916412|NCT00640250|OG005|Outcome|Bronopol 0.500 mg/cm2|Concordance between bronopol and the reference petrolatum allergen
10916413|NCT00640250|OG006|Outcome|Bronopol 0.750 mg/cm2|Concordance between bronopol and the reference petrolatum allergen
10916414|NCT00640250|OG000|Outcome|Disperse Blue Irritation Reactions|Percentage of subjects who exhibited irritation (tape reactions) to disperse blue panel
10916415|NCT00640250|OG001|Outcome|Bronopol Irritation Reactions|Percentage of subjects who exhibited irritation (tape reactions) to bronopol panel
10916416|NCT00640250|OG002|Outcome|Disperse Blue Itching and/or Burning|Percentage of subjects who exhibited itching and/or burning to disperse blue panel
10916417|NCT00640250|OG003|Outcome|Bronopol Itching and/or Burning|Percentage of subjects who exhibited itching and/or burning to bronopol panel
10916418|NCT00640250|OG004|Outcome|Disperse Blue 0.017 Late Reactions|Percentage of subjects who exhibited late reactions
10916419|NCT00640250|OG005|Outcome|Disperse Blue 0.050 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
10916420|NCT00640250|OG006|Outcome|Disperse Blue 0.150 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
10916421|NCT00640250|OG007|Outcome|Negative Control Late Reactions|Percentage of subjects who exhibited late reactions
10916422|NCT00640250|OG008|Outcome|Disperse Blue 0.017 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
10916423|NCT00640250|OG009|Outcome|Disperse Blue 0.050 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
10916424|NCT00640250|OG010|Outcome|Disperse Blue 0.150 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
10916425|NCT00640250|OG011|Outcome|Negative Control Persistent Reactions|Percentage of subjects who exhibited persistent reactions
10916426|NCT00640250|OG012|Outcome|Bronopol 0.125 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
10916427|NCT00640250|OG013|Outcome|Bronopol 0.250 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
10916428|NCT00640250|OG014|Outcome|Bronopol 0.500 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
10916429|NCT00640250|OG015|Outcome|Bronopol 0.750 mg/cm2 LateReactions|Percentage of subjects who exhibited late reactions
10916430|NCT00640250|OG016|Outcome|Bronopol 0.125 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
10916431|NCT00640250|OG017|Outcome|Bronopol 0.250 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
10916432|NCT00640250|OG018|Outcome|Bronopol 0.500 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
10916433|NCT00640250|OG019|Outcome|Bronopol 0.750 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
10916434|NCT00640250|OG000|Outcome|Adverse Events Related to Investigational Panel|Number of reported adverse events related to investigational or reference allergens.
10916435|NCT00640250|OG001|Outcome|Adverse Events Not Related|Number of adverse events not related to investigational or reference allergens
10916436|NCT00640250|EG000|Reported Event|All Subjects|
10916437|NCT00640289|BG000|Baseline|Factor XIII|
10916438|NCT00640289|FG000|Participant Flow|Factor XIII|Prophylactic dose of Factor XIII Concentrate (Human) was to be 10 to 20 U/kg b.w. administered IV over 5 minutes once every 4 weeks, and later tailored to subjects PK profile.
10916439|NCT00640289|OG000|Outcome|Factor XIII|
10916440|NCT00640289|EG000|Reported Event|Factor XIII|
10916441|NCT00640315|BG000|Baseline|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
10916442|NCT00640315|BG001|Baseline|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
10916443|NCT00640315|BG002|Baseline|Total|Total of all reporting groups
10916444|NCT00640315|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
10916445|NCT00640315|FG001|Participant Flow|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
10916446|NCT00640315|OG000|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
10916447|NCT00640315|OG001|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
10916448|NCT00640315|EG000|Reported Event|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
10916449|NCT00640315|EG001|Reported Event|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
10916450|NCT00640328|BG000|Baseline|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
10963134|NCT00870467|FG002|Participant Flow|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
10916451|NCT00640328|BG001|Baseline|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
10916452|NCT00640328|BG002|Baseline|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
10916453|NCT00640328|BG003|Baseline|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
10916454|NCT00640328|BG004|Baseline|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
10916455|NCT00640328|BG005|Baseline|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
10916456|NCT00640328|BG006|Baseline|Total|Total of all reporting groups
10916457|NCT00640328|FG000|Participant Flow|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916458|NCT00640328|FG001|Participant Flow|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916459|NCT00640328|FG002|Participant Flow|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916460|NCT00640328|FG003|Participant Flow|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916461|NCT00640328|FG004|Participant Flow|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916462|NCT00640328|FG005|Participant Flow|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916463|NCT00640328|OG000|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10963135|NCT00870467|FG003|Participant Flow|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
11174456|NCT02022007|FG001|Participant Flow|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
10916464|NCT00640328|OG001|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916465|NCT00640328|OG002|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916466|NCT00640328|OG003|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916467|NCT00640328|OG004|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916468|NCT00640328|OG005|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916469|NCT00640328|OG004|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before consideAfter completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.ring progression to the 700 mg dose.
10916470|NCT00640328|OG000|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
10916471|NCT00640328|OG001|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
10916472|NCT00640328|OG002|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
10916473|NCT00640328|OG003|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
10916474|NCT00640328|OG004|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
10916475|NCT00640328|OG005|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
10916476|NCT00640328|EG000|Reported Event|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10963136|NCT00870467|FG004|Participant Flow|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
10916477|NCT00640328|EG001|Reported Event|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916478|NCT00640328|EG002|Reported Event|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916479|NCT00640328|EG003|Reported Event|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916480|NCT00640328|EG004|Reported Event|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916481|NCT00640328|EG005|Reported Event|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
10916482|NCT00640341|BG000|Baseline|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
10916483|NCT00640341|BG001|Baseline|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
10916484|NCT00640341|BG002|Baseline|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
10916485|NCT00640341|BG003|Baseline|Total|Total of all reporting groups
10916486|NCT00640341|FG000|Participant Flow|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
10916487|NCT00640341|FG001|Participant Flow|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
10916488|NCT00640341|FG002|Participant Flow|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
11357561|NCT03756012|FG000|Participant Flow|Total Patient Population|This was a case series and all patients received both algorithms; pulse widths <500 µsec and >1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
10916489|NCT00640341|OG000|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
10916490|NCT00640341|OG001|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
10916491|NCT00640341|OG002|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
10916492|NCT00640341|EG000|Reported Event|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
10916493|NCT00640341|EG001|Reported Event|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
10916494|NCT00640341|EG002|Reported Event|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
10916495|NCT00640393|BG000|Baseline|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
10916496|NCT00640393|FG000|Participant Flow|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
10916497|NCT00640393|FG001|Participant Flow|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
10916498|NCT00640393|FG002|Participant Flow|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
10916499|NCT00640393|OG000|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
10916500|NCT00640393|OG001|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
10916501|NCT00640393|OG002|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
10916502|NCT00640393|EG000|Reported Event|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
10916503|NCT00640393|EG001|Reported Event|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
10916504|NCT00640393|EG002|Reported Event|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
10916505|NCT00640510|BG000|Baseline|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
10916506|NCT00640510|BG001|Baseline|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
10916507|NCT00640510|BG002|Baseline|Total|Total of all reporting groups
10916508|NCT00640510|FG000|Participant Flow|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
10916509|NCT00640510|FG001|Participant Flow|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
10916510|NCT00640510|OG000|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
10916511|NCT00640510|OG001|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
10916512|NCT00640510|EG000|Reported Event|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
10916513|NCT00640510|EG001|Reported Event|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
10916514|NCT00640562|BG000|Baseline|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
10916515|NCT00640562|BG001|Baseline|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
10916516|NCT00640562|BG002|Baseline|Total|Total of all reporting groups
10916517|NCT00640562|FG000|Participant Flow|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
10916518|NCT00640562|FG001|Participant Flow|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
10916519|NCT00640562|OG000|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
10916520|NCT00640562|OG001|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
10963137|NCT00870467|FG005|Participant Flow|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
10916521|NCT00640562|EG000|Reported Event|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
10916522|NCT00640562|EG001|Reported Event|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
10916523|NCT00640601|BG000|Baseline|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
10916524|NCT00640601|FG000|Participant Flow|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
10916525|NCT00640601|OG000|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
10916526|NCT00640601|EG000|Reported Event|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
10916527|NCT00640614|BG000|Baseline|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
10916528|NCT00640614|BG001|Baseline|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
10916529|NCT00640614|BG002|Baseline|Total|Total of all reporting groups
10916530|NCT00640614|FG000|Participant Flow|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
10916531|NCT00640614|FG001|Participant Flow|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
10916532|NCT00640614|OG000|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
10916533|NCT00640614|OG000|Outcome|Sensitivity|The agreement between positive results for gold sodium thiosulfate and reference allergen
10916534|NCT00640614|OG001|Outcome|Specificity|The agreement between the negative results for gold sodium thiosulfate and the reference allergen
10916535|NCT00640614|OG000|Outcome|Sensitivity|The agreement between positive results for hydrocortisone-17-butyrate and reference allergen
10916536|NCT00640614|OG001|Outcome|Specificity|The agreement between negative results for hydrocortisone-17-butyrate and the reference allergen
10916537|NCT00640614|OG000|Outcome|Sensitivity|The agreement between positive results for methyldibromo-glutaronitrile and reference allergen
10916538|NCT00640614|OG001|Outcome|Specificity|The agreement between the negative results for methyldibromo-glutaronitrile and the reference allergen
10916539|NCT00640614|OG000|Outcome|Sensitivity|The agreement between positive results for bacitracin and reference allergen
10916540|NCT00640614|OG001|Outcome|Specificity|The agreement between the negative results for bacitracin and the reference allergen
10916541|NCT00640614|OG000|Outcome|Sensitivity|The agreement between positive results for parthenolide and reference allergen
10916542|NCT00640614|OG001|Outcome|Specificity|The agreement between negative results for parthenolide and the reference allergen
10916543|NCT00640614|OG000|Outcome|Sensitivity|The agreement between positive results for disperse blue and the reference allergen
10916544|NCT00640614|OG001|Outcome|Specificity|The agreement between negative results for disperse blue and the reference allergen
10916545|NCT00640614|OG000|Outcome|Sensitivity|The agreement between positive results for bronopol and reference allergen
10916546|NCT00640614|OG001|Outcome|Specificity|The agreement between negative results for bronopol and the reference allergen
10916547|NCT00640614|OG000|Outcome|Panel Irritation|Irritation from the test panel adhesive and/or tape was scored at day 2 following patch removal
10916548|NCT00640614|OG001|Outcome|Itching and Burning|Subject reported sensations of itching and burning were captured at day 2 following patch removal
10916549|NCT00640614|OG002|Outcome|Adhesion|Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.
10916550|NCT00640614|OG000|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
10916551|NCT00640614|OG001|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
10916552|NCT00640614|OG002|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
10916553|NCT00640614|OG003|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
10916554|NCT00640614|OG004|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
10916555|NCT00640614|OG005|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
10916556|NCT00640614|OG006|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
10916557|NCT00640614|EG000|Reported Event|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
10916558|NCT00640614|EG001|Reported Event|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
10916559|NCT00640653|BG000|Baseline|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
10916560|NCT00640653|BG001|Baseline|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
10916561|NCT00640653|BG002|Baseline|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
10916562|NCT00640653|BG003|Baseline|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
10916563|NCT00640653|BG004|Baseline|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
10916564|NCT00640653|BG005|Baseline|Total|Total of all reporting groups
10916565|NCT00640653|FG000|Participant Flow|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
10916566|NCT00640653|FG001|Participant Flow|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
10916567|NCT00640653|FG002|Participant Flow|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
10916568|NCT00640653|FG003|Participant Flow|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
10916569|NCT00640653|FG004|Participant Flow|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
10916570|NCT00640653|OG000|Outcome|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
10916571|NCT00640653|OG001|Outcome|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
10916572|NCT00640653|OG002|Outcome|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
10916573|NCT00640653|OG003|Outcome|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
10916574|NCT00640653|OG004|Outcome|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
10916575|NCT00640653|EG000|Reported Event|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
10916576|NCT00640653|EG001|Reported Event|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
10916577|NCT00640653|EG002|Reported Event|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
10916578|NCT00640653|EG003|Reported Event|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
10916579|NCT00640653|EG004|Reported Event|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
10916580|NCT00640822|BG000|Baseline|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
10916581|NCT00640822|BG001|Baseline|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
10916582|NCT00640822|BG002|Baseline|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
10916583|NCT00640822|BG003|Baseline|Total|Total of all reporting groups
10916584|NCT00640822|FG000|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
10916585|NCT00640822|FG001|Participant Flow|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
10916586|NCT00640822|FG002|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
10916587|NCT00640822|OG000|Outcome|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
11174457|NCT02022007|FG002|Participant Flow|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
11174458|NCT02022007|OG000|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
11174459|NCT02022007|OG001|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
11357562|NCT03756012|OG000|Outcome|Total Patient Population|"This was a case series and all patients received both algorithms; pulse widths <500 µsec and >1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.~Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
10916588|NCT00640822|OG001|Outcome|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
11174460|NCT02022007|OG002|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
10916589|NCT00640822|OG002|Outcome|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
10916590|NCT00640822|EG000|Reported Event|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
10916591|NCT00640822|EG001|Reported Event|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
10916592|NCT00640822|EG002|Reported Event|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
10916593|NCT00640835|BG000|Baseline|Buprenorphine/Naloxone Film Strip Administered Sublingually|
10916594|NCT00640835|BG001|Baseline|Buprenorphine/Naloxone Film Strip Administered Buccally|
10916595|NCT00640835|BG002|Baseline|Total|Total of all reporting groups
10916596|NCT00640835|FG000|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Sublingually|
10916597|NCT00640835|FG001|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Buccally|
10916598|NCT00640835|OG000|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
10916599|NCT00640835|OG001|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
10916600|NCT00640835|EG000|Reported Event|Buprenorphine/Naloxone Film Strip Administered Sublingually|
10916601|NCT00640835|EG001|Reported Event|Buprenorphine/Naloxone Film Strip Administered Buccally|
10916602|NCT00640926|BG000|Baseline|Radezolid 300 mg PO Daily (QD)|
10916603|NCT00640926|BG001|Baseline|Radezolid 450 mg PO Daily (QD)|
10916604|NCT00640926|BG002|Baseline|Radezolid 450 mg PO Twice Daily (BID)|
10916605|NCT00640926|BG003|Baseline|Total|Total of all reporting groups
10916606|NCT00640926|FG000|Participant Flow|Radezolid 300 mg PO Daily (QD)|
10916607|NCT00640926|FG001|Participant Flow|Radezolid 450 mg PO Daily (QD)|
10916608|NCT00640926|FG002|Participant Flow|Radezolid 450 mg PO Twice Daily (BID)|
10916609|NCT00640926|OG000|Outcome|Radezolid 300 mg PO Daily (QD)|
10916610|NCT00640926|OG001|Outcome|Radezolid 450 mg PO Daily (QD)|
10916611|NCT00640926|OG002|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
10916612|NCT00640926|EG000|Reported Event|Radezolid 300 mg PO Daily (QD)|
10916613|NCT00640926|EG001|Reported Event|Radezolid 450 mg PO Daily (QD)|
10916614|NCT00640926|EG002|Reported Event|Radezolid 450 mg PO Twice Daily (BID)|
10916615|NCT00640978|BG000|Baseline|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
10916616|NCT00640978|FG000|Participant Flow|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
10916617|NCT00640978|OG000|Outcome|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
10916618|NCT00640978|EG000|Reported Event|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
10916619|NCT00641043|BG000|Baseline|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
10916620|NCT00641043|BG001|Baseline|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
10916621|NCT00641043|BG002|Baseline|Total|Total of all reporting groups
10916622|NCT00641043|FG000|Participant Flow|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
10916623|NCT00641043|FG001|Participant Flow|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
10916624|NCT00641043|OG000|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
10916625|NCT00641043|OG001|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
10916626|NCT00641043|EG000|Reported Event|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
10916627|NCT00641043|EG001|Reported Event|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
10916628|NCT00641056|BG000|Baseline|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
10916629|NCT00641056|BG001|Baseline|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
10916630|NCT00641056|BG002|Baseline|Total|Total of all reporting groups
10916631|NCT00641056|FG000|Participant Flow|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
10916632|NCT00641056|FG001|Participant Flow|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
10916633|NCT00641056|OG000|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
10916634|NCT00641056|OG001|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
10916635|NCT00641056|OG000|Outcome|Exenatide Once Weekly With SU|Patients assigned to the Exenatide Once Weekly With SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met+SU.
10916636|NCT00641056|OG001|Outcome|Insulin Glargine With SU|Patients assigned to the Insulin Glargine with SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met+SU.
10916637|NCT00641056|OG002|Outcome|Exenatide Once Weekly No SU|Patients assigned to the Exenatide Once Weekly No SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met only.
10916638|NCT00641056|OG003|Outcome|Insulin Glargine No SU|Patients assigned to the Insulin Glargine No SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met only.
10916639|NCT00641056|EG000|Reported Event|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
10916640|NCT00641056|EG001|Reported Event|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
10916641|NCT00641147|BG000|Baseline|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
10916642|NCT00641147|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
10916643|NCT00641147|BG002|Baseline|Total|Total of all reporting groups
10916644|NCT00641147|FG000|Participant Flow|Arm I (Curcumin)|"Patients receive curcumin by mouth (PO) twice a day (BID) for 12 months.~Curcumin: Given PO"
10916645|NCT00641147|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
10916646|NCT00641147|OG000|Outcome|Arm I (Curcumin)|"Patients receive curcumin 3.0 grams PO BID for 12 months.~Curcumin: Given PO"
10916647|NCT00641147|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
10916648|NCT00641147|OG000|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
10916649|NCT00641147|OG000|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10916650|NCT00641147|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO"
10916651|NCT00641147|OG000|Outcome|Arm I (Curcumin)|"Patients receive curcumin by mouth (PO) twice a day (BID) for 12 months.~Curcumin: Given PO"
10916652|NCT00641147|EG000|Reported Event|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
10916653|NCT00641147|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
10916654|NCT00641563|BG000|Baseline|All Study Participants|Both arms combined
10916655|NCT00641563|FG000|Participant Flow|Dex/Remi Followed by Mida/Remi|Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week
10916656|NCT00641563|FG001|Participant Flow|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
10916657|NCT00641563|OG000|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
10916658|NCT00641563|OG001|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
10916659|NCT00641563|EG000|Reported Event|Dex/Remi|Sedation with dexmedetomidine and remifentanil
11357563|NCT03756012|OG000|Outcome|Total Patient Population|This was a case series and all patients received both algorithms; pulse widths <500 µsec and >1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
10916660|NCT00641563|EG001|Reported Event|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
10916661|NCT00641641|BG000|Baseline|Drug Intervention|Tenofovir+emtricitabine+raltegravir
10916662|NCT00641641|FG000|Participant Flow|Drug Intervention|Tenofovir+emtricitabine+raltegravir
10916663|NCT00641641|OG000|Outcome|Drug Intervention|Tenofovir+emtricitabine+raltegravir
10916664|NCT00641641|EG000|Reported Event|Drug Intervention|Tenofovir+emtricitabine+raltegravir
10916665|NCT00641667|BG000|Baseline|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
10916666|NCT00641667|FG000|Participant Flow|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
10916667|NCT00641667|OG000|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
10916668|NCT00641667|EG000|Reported Event|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
10916669|NCT00641706|BG000|Baseline|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
10963138|NCT00870467|OG000|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
10916670|NCT00641706|BG001|Baseline|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery~bortezomib : Given IV~vorinostat : Given orally"
10916671|NCT00641706|BG002|Baseline|Total|Total of all reporting groups
10916672|NCT00641706|FG000|Participant Flow|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
10916673|NCT00641706|FG001|Participant Flow|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery~bortezomib : Given IV~vorinostat : Given orally"
10916674|NCT00641706|OG000|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
10916675|NCT00641706|OG001|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
10916676|NCT00641706|EG000|Reported Event|Arm A (Not Undergoing Surgery)|vorinostat : Given orally
10916677|NCT00641706|EG001|Reported Event|Arm B (Undergoing Surgery)|vorinostat : Given orally
10916678|NCT00641719|BG000|Baseline|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
10916679|NCT00641719|BG001|Baseline|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
10916680|NCT00641719|BG002|Baseline|Total|Total of all reporting groups
10916681|NCT00641719|FG000|Participant Flow|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
10916682|NCT00641719|FG001|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
10916683|NCT00641719|OG000|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
10916684|NCT00641719|OG001|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
10916685|NCT00641719|EG000|Reported Event|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
10916686|NCT00641719|EG001|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
11174461|NCT02022007|EG000|Reported Event|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
11174462|NCT02022007|EG001|Reported Event|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
10916687|NCT00641745|BG000|Baseline|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
10916688|NCT00641745|BG001|Baseline|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
10916689|NCT00641745|BG002|Baseline|Total|Total of all reporting groups
10916690|NCT00641745|FG000|Participant Flow|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
10916691|NCT00641745|FG001|Participant Flow|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
10916692|NCT00641745|OG000|Outcome|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
10916693|NCT00641745|OG001|Outcome|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
10916694|NCT00641745|EG000|Reported Event|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
10916695|NCT00641745|EG001|Reported Event|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
10916696|NCT00641797|BG000|Baseline|Arm 1, Conventional Therapy|"Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).~Meclizine: medication administration 25mg PO one time~Lorazepam: Lorazepam 1 - 5mg PO/IV prn~Diphenhydramine: 25 - 50mg PO/IV once prn~Ondansetron: Ondansetron 4 - 8 mg PO/IV prn"
10916697|NCT00641797|BG001|Baseline|Arm 2, Epley Maneuver|"Patients will receive vestibular rehabilitation (the Epley Maneuver).~Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver."
10916698|NCT00641797|BG002|Baseline|Total|Total of all reporting groups
10916699|NCT00641797|FG000|Participant Flow|Arm 1, Conventional Therapy|"Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).~Meclizine: medication administration 25mg PO one time~Lorazepam: Lorazepam 1 - 5mg PO/IV prn~Diphenhydramine: 25 - 50mg PO/IV once prn~Ondansetron: Ondansetron 4 - 8 mg PO/IV prn"
10916700|NCT00641797|FG001|Participant Flow|Arm 2, Epley Maneuver|"Patients will receive vestibular rehabilitation (the Epley Maneuver).~Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver."
10916701|NCT00641797|OG000|Outcome|Arm 1, Conventional Therapy|"Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).~Meclizine: medication administration 25mg PO one time~Lorazepam: Lorazepam 1 - 5mg PO/IV prn~Diphenhydramine: 25 - 50mg PO/IV once prn~Ondansetron: Ondansetron 4 - 8 mg PO/IV prn"
10916702|NCT00641797|OG001|Outcome|Arm 2, Epley Maneuver|"Patients will receive vestibular rehabilitation (the Epley Maneuver).~Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver."
10963139|NCT00870467|OG001|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
10916703|NCT00641797|EG000|Reported Event|Arm 1, Conventional Therapy|"Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).~Meclizine: medication administration 25mg PO one time~Lorazepam: Lorazepam 1 - 5mg PO/IV prn~Diphenhydramine: 25 - 50mg PO/IV once prn~Ondansetron: Ondansetron 4 - 8 mg PO/IV prn"
10916704|NCT00641797|EG001|Reported Event|Arm 2, Epley Maneuver|"Patients will receive vestibular rehabilitation (the Epley Maneuver).~Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver."
10916705|NCT00641862|BG000|Baseline|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
10916706|NCT00641862|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
10916707|NCT00641862|BG002|Baseline|Total|Total of all reporting groups
10916708|NCT00641862|FG000|Participant Flow|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
10916709|NCT00641862|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
10916710|NCT00641862|OG000|Outcome|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
10916711|NCT00641862|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
10916712|NCT00641862|EG000|Reported Event|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
10916713|NCT00641862|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
10916714|NCT00642018|BG000|Baseline|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
10916715|NCT00642018|BG001|Baseline|LY2181308 + Docetaxel|LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
10916716|NCT00642018|BG002|Baseline|Total|Total of all reporting groups
10916717|NCT00642018|FG000|Participant Flow|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
10916718|NCT00642018|FG001|Participant Flow|LY2181308 + Docetaxel|LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
10916719|NCT00642018|OG000|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
10916720|NCT00642018|OG001|Outcome|LY2181308 + Docetaxel|LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
10916721|NCT00642018|OG001|Outcome|LY2181308|LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first cycle.
10916722|NCT00642018|EG000|Reported Event|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
10916723|NCT00642018|EG001|Reported Event|LY2181308 + Docetaxel|LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
10916724|NCT00642174|BG000|Baseline|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
10916725|NCT00642174|BG001|Baseline|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
10916726|NCT00642174|BG002|Baseline|Total|Total of all reporting groups
10916727|NCT00642174|FG000|Participant Flow|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
10916728|NCT00642174|FG001|Participant Flow|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
10916729|NCT00642174|OG000|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
10916730|NCT00642174|OG001|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
10916731|NCT00642174|EG000|Reported Event|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
10916732|NCT00642174|EG001|Reported Event|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
10916733|NCT00642278|BG000|Baseline|Placebo|Each patient received matching placebo twice daily for 12 weeks.
11174463|NCT02022007|EG002|Reported Event|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
11174464|NCT02022020|BG000|Baseline|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
11174465|NCT02022020|FG000|Participant Flow|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
11174466|NCT02022020|OG000|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
11174467|NCT02022020|EG000|Reported Event|Dabigatran (Pradax® in Canada; Pradaxa® in the United States|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
11174468|NCT02022085|BG000|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
11174469|NCT02022085|FG000|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
11174470|NCT02022085|OG000|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
11174471|NCT02022085|EG000|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
11174472|NCT02022111|BG000|Baseline|Intervention Program of Care|"Includes 4 components:~Patient Education and Behavioral Activation by a Care Coordinator;~Supporting Self-Care;~Psychiatrist and Diabetologist Reviews; and~Decision-support Electronic Health Record System"
11174473|NCT02022111|BG001|Baseline|Control Arm|Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
11174474|NCT02022111|BG002|Baseline|Total|Total of all reporting groups
11174475|NCT02022111|FG000|Participant Flow|Intervention Program of Care|"Includes 4 components:~Patient Education and Behavioral Activation by a Care Coordinator;~Supporting Self-Care;~Psychiatrist and Diabetologist Reviews; and~Decision-support Electronic Health Record System"
11174476|NCT02022111|FG001|Participant Flow|Control Arm|Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
11174477|NCT02022111|OG000|Outcome|Intervention Program of Care|"Includes 4 components:~Patient Education and Behavioral Activation by a Care Coordinator;~Supporting Self-Care;~Psychiatrist and Diabetologist Reviews; and~Decision-support Electronic Health Record System"
11174478|NCT02022111|OG001|Outcome|Control Arm|Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
11174479|NCT02022111|OG000|Outcome|Difference Between Intervention Program of Care Arm and Control Arm|"The Intervention group includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; supporting Self-Care; psychiatrist and diabetologist reviews; and decision-support Electronic Health Record System~The control Group received standard of care and were contacted only at 6 months intervals for assessment by the blinded outcomes assessor."
11174480|NCT02022111|OG000|Outcome|Incremental Cost Utility Ratio|Includes participants in both study groups: Intervention and Control group
11174481|NCT02022111|EG000|Reported Event|Intervention Program of Care|"Includes 4 components:~Patient Education and Behavioral Activation by a Care Coordinator;~Supporting Self-Care;~Psychiatrist and Diabetologist Reviews; and~Decision-support Electronic Health Record System"
11174482|NCT02022111|EG001|Reported Event|Control Arm|Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
11174483|NCT02022657|BG000|Baseline|All Dosing Regimens|Baseline characteristics for all 48 subjects included in analysis. Baseline characteristics not stratified based on dosing regimen.
11174484|NCT02022657|FG000|Participant Flow|100% First, Then 67%|"100% dosing: Dose every day for ~12 weeks 67% holiday dosing regimen: 2 weeks on medication, 1 week off, repeat for ~ 12 weeks 67% intermittent dosing regimen: 2 days on medication, 1 day off, repeat for ~ 12 weeks~67% Intermittent and 67% Holiday dosing combined for analysis."
10916734|NCT00642278|BG001|Baseline|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916735|NCT00642278|BG002|Baseline|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916736|NCT00642278|BG003|Baseline|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916737|NCT00642278|BG004|Baseline|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916738|NCT00642278|BG005|Baseline|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
11174485|NCT02022657|FG001|Participant Flow|100% First, Then 33%|"100% dosing regimen: dosing every day for ~12 weeks 33% holiday dosing regimen: 1 week on medication, 2 weeks off, repeat for ~ 12 weeks 33% intermittent dosing regimen:1 day on medication, 2 days off, repeat for ~ 12 weeks~33% Intermittent and 33% Holiday dosing combined for analysis."
11174486|NCT02022657|FG002|Participant Flow|67% First, Then 100%|"67% holiday dosing regimen: 2 weeks on medication, 1 week off, repeat for ~ 12 weeks 67% intermittent dosing regimen: 2 days on medication, 1 day off, repeat for ~ 12 weeks 100% dosing regimen: dosing every day, repeat for ~12 weeks~67% Intermittent and 67% Holiday dosing combined for analysis."
11174487|NCT02022657|FG003|Participant Flow|67% First, Then 33%|"67% holiday dosing regimen: 2 weeks on medication, 1 week off, repeat for ~ 12 weeks 67% intermittent dosing regimen: 2 days on medication, 1 day off, repeat for ~ 12 weeks 33% holiday dosing regimen: 1 week on medication, 2 weeks off, repeat for ~ 12 weeks 33% intermittent dosing regimen:1 day on medication, 2 days off, repeat for ~ 12 weeks~67% Intermittent and 67% Holiday dosing combined for analysis. 33% Intermittent and 33% Holiday dosing combined for analysis."
11174488|NCT02022657|FG004|Participant Flow|33% First, Then 100%|"33% holiday dosing regimen: 1 week on medication, 2 weeks off, repeat for ~ 12 weeks 33% intermittent dosing regimen:1 day on medication, 2 days off, repeat for ~ 12 weeks 100% dosing: Dose every day for ~12 weeks~33% Intermittent and 33% Holiday dosing combined for analysis."
11174489|NCT02022657|FG005|Participant Flow|33% First, Then 67%|"33% holiday dosing regimen: 1 week on medication, 2 weeks off, repeat for ~ 12 weeks 33% intermittent dosing regimen:1 day on medication, 2 days off, repeat for ~ 12 weeks 67% holiday dosing regimen: 2 weeks on medication, 1 week off, repeat for ~ 12 weeks 67% intermittent dosing regimen: 2 days on medication, 1 day off, repeat for ~ 12 weeks~33% Intermittent and 33% Holiday dosing combined for analysis. 67% Intermittent and 67% Holiday dosing combined for analysis."
11174490|NCT02022657|OG000|Outcome|DOT-DBS Dosing 33%|33%
11174491|NCT02022657|OG001|Outcome|DOT-DBS Dosing 67%|67%
11174492|NCT02022657|OG002|Outcome|DOT-DBS Dosing 100%|
11174493|NCT02022657|EG000|Reported Event|All Dosing Regimens|Overall, the study showed an unremarkable and expected AE profile. At study initiation Truvada was FDA approved for daily dosing (100% daily dosing). Thus, the AE profile was already established for 100% dosing and AE rates in the lower doses (33% and 67%) would not exceed the established rate for daily dosing (100%). This study was not designed to collect new safety data or to update the established AE/Safety profiles for Truvada. Therefore AE data was combined for all dosing regimens since AEs reported per arm/group are not meaningful for research or clinical applications.
10916739|NCT00642278|BG006|Baseline|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916740|NCT00642278|BG007|Baseline|Total|Total of all reporting groups
10916741|NCT00642278|FG000|Participant Flow|Placebo|Each patient received matching placebo twice daily for 12 weeks.
10916742|NCT00642278|FG001|Participant Flow|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916743|NCT00642278|FG002|Participant Flow|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916744|NCT00642278|FG003|Participant Flow|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916745|NCT00642278|FG004|Participant Flow|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916746|NCT00642278|FG005|Participant Flow|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
11174494|NCT02022670|BG000|Baseline|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
11174495|NCT02022670|BG001|Baseline|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
11174496|NCT02022670|BG002|Baseline|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
11174497|NCT02022670|BG003|Baseline|Total|Total of all reporting groups
11174498|NCT02022670|FG000|Participant Flow|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
11174499|NCT02022670|FG001|Participant Flow|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
11174500|NCT02022670|FG002|Participant Flow|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
11174501|NCT02022670|OG000|Outcome|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
11174502|NCT02022670|OG001|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
11174503|NCT02022670|OG002|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
11174504|NCT02022670|OG000|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks~Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
11174505|NCT02022670|EG000|Reported Event|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
11174506|NCT02022670|EG001|Reported Event|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
11174507|NCT02022670|EG002|Reported Event|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
11174508|NCT02022735|BG000|Baseline|All Participants|All participants that completed the 4 arm crossover study design
10916747|NCT00642278|FG006|Participant Flow|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
11174509|NCT02022735|FG000|Participant Flow|All Participants|All participants enrolled in the study completed the 4 arms crossover study design. All participants received and was evaluated for all four interventions: Bilateral Deep Brain Stimulation (DBS), Right Side DBS, Left side DBS and Off/No Stimulation.
11174510|NCT02022735|OG000|Outcome|Bilateral Stimulation|Participants will receive Deep Brain Stimulation Bilaterally.
11174511|NCT02022735|OG001|Outcome|Left Stimulation|Participants will receive Deep Brain Stimulation on the left side only
11174512|NCT02022735|OG002|Outcome|Right Stimulation|Participants will receive Deep Brain Stimulation on the right side only
11174513|NCT02022735|OG003|Outcome|OFF Stimulation|Participants will receive no Deep Brain Stimulation
11174514|NCT02022735|EG000|Reported Event|Bilateral Stimulation|Participants will receive Deep Brain Stimulation Bilaterally.
10916748|NCT00642278|OG000|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
11174515|NCT02022735|EG001|Reported Event|Left Stimulation|Participants will receive Deep Brain Stimulation on the left side only
11174516|NCT02022735|EG002|Reported Event|Right Stimulation|Participants will receive Deep Brain Stimulation on the right side only
11174517|NCT02022735|EG003|Reported Event|OFF Stimulation|Participants will receive no Deep Brain Stimulation
11174518|NCT02022748|BG000|Baseline|HD Subjects|Hemodialysis subjects
10916749|NCT00642278|OG001|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
11174519|NCT02022748|BG001|Baseline|HS Subjects|Healthy subjects
11174520|NCT02022748|BG002|Baseline|Total|Total of all reporting groups
11174521|NCT02022748|FG000|Participant Flow|Sequence 1 (AB)|hemodialysis patients: subjects will receive treatment A (ticagrelor oral 90 mg 1 day following the dialysis session but 2 days before the next dialysis session) in period 1 and treatment B (ticagrelor oral 90 mg just prior to dialysis session) in period 2.
11174522|NCT02022748|FG001|Participant Flow|Sequence 2 (BA)|Hemodialysis patients: subjects will receive treatment B (ticagrelor oral 90 mg just prior to dialysis session) in period 1 and treatment A (ticagrelor oral 90 mg 1 day following the dialysis session but 2 days before the next dialysis session) in period 2.
11174523|NCT02022748|FG002|Participant Flow|Treatment H|Healthy subjects: ticagrelor oral 90 mg on 1 day of treatment
11174524|NCT02022748|OG000|Outcome|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
11174525|NCT02022748|OG001|Outcome|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
11174526|NCT02022748|OG002|Outcome|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
11174527|NCT02022748|EG000|Reported Event|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
11174528|NCT02022748|EG001|Reported Event|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
10916750|NCT00642278|OG002|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
11174529|NCT02022748|EG002|Reported Event|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
11174530|NCT02022826|BG000|Baseline|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
11174531|NCT02022826|FG000|Participant Flow|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
11174532|NCT02022826|OG000|Outcome|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
11174533|NCT02022826|EG000|Reported Event|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
11174534|NCT02023099|BG000|Baseline|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
11174535|NCT02023099|BG001|Baseline|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
11174536|NCT02023099|BG002|Baseline|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
11174537|NCT02023099|BG003|Baseline|Total|Total of all reporting groups
11174538|NCT02023099|FG000|Participant Flow|Substudy 1, Arm A: DB 2-DAA|Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis
11174539|NCT02023099|FG001|Participant Flow|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
11174540|NCT02023099|FG002|Participant Flow|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
11174541|NCT02023099|OG000|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
11174542|NCT02023099|OG001|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
11174543|NCT02023099|EG000|Reported Event|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis.
11174544|NCT02023099|EG001|Reported Event|Substudy 1, Arm B: DB Placebo|DB placebo QD for 12 weeks in participants without cirrhosis
11174545|NCT02023099|EG002|Reported Event|Substudy 1, Arm B: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
11174546|NCT02023099|EG003|Reported Event|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
11174547|NCT02023112|BG000|Baseline|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
11174548|NCT02023112|BG001|Baseline|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
11174549|NCT02023112|BG002|Baseline|Total|Total of all reporting groups
11174550|NCT02023112|FG000|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks
11174551|NCT02023112|FG001|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
11174552|NCT02023112|OG000|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
11174553|NCT02023112|OG001|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
11174554|NCT02023112|EG000|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants
11174555|NCT02023112|EG001|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants
11174556|NCT02023112|EG002|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants
11174557|NCT02023112|EG003|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants
11174558|NCT02023125|BG000|Baseline|Group 1 (Treatment Sequence AB or BA)|Participants in Group 1 were randomly assigned to a two period treatment sequence (AB or BA) in which they received a single, oral dose of 600 mg of alectinib per period separated by at least 10 days. Each participant received single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence.
11174559|NCT02023125|BG001|Baseline|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
11174560|NCT02023125|BG002|Baseline|Total|Total of all reporting groups
11174561|NCT02023125|FG000|Participant Flow|Group 1: Treatment A First, Then Treatment B|Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600 milligrams (mg) oral dose of alectinib was administered. Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Each period was separated by at least 10 days.
11234013|NCT02431793|BG002|Baseline|EMC2 Strategy + SMS Text Reminders|"In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.~EMC2 Strategy: Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.~Short Message Service (SMS) Text Reminders: In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days."
11234014|NCT02431793|BG003|Baseline|Total|Total of all reporting groups
11234015|NCT02431793|FG000|Participant Flow|Usual Care|Employ the standard of care, no intervention
11234016|NCT02431793|FG001|Participant Flow|EMC2 Strategy|"Patients of providers randomized to EMC2 arm will receive educational tool from the Emergency Department (ED) to support the understanding and safe use of opioids.~A single-page medication information sheet with content from a patients perspective, following health literacy best practices.~Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.~Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if in-system PCP) notifying them of ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription."
11234017|NCT02431793|FG002|Participant Flow|EMC2 Strategy + SMS Text Reminders|"In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.~EMC2 Strategy: Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) a single-page medication information sheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via electronic health record (EHR), (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.~SMS Text Reminders: In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days."
11234018|NCT02431793|OG000|Outcome|Usual Care|Employ the standard of care, no intervention
11234019|NCT02431793|OG001|Outcome|EMC2 Strategy|"Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.~A single-page medication information sheet with content from a patients perspective and following health literacy best practices.~Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.~Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed on the prescription."
11234020|NCT02431793|OG002|Outcome|EMC2 Strategy + SMS Text Reminders|"In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.~EMC2 Strategy: Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.~Short Message Service (SMS) Text Reminders: In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days."
11234021|NCT02431793|EG000|Reported Event|Usual Care|Employ the standard of care, no intervention
11234022|NCT02431793|EG001|Reported Event|EMC2 Strategy|"Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.~A single-page medication information sheet with content from a patients perspective and following health literacy best practices.~Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.~Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed on the prescription."
11234023|NCT02431793|EG002|Reported Event|EMC2 Strategy + SMS Text Reminders|"In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.~EMC2 Strategy: Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.~Short Message Service (SMS) Text Reminders: In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days."
10916751|NCT00642278|OG003|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916752|NCT00642278|OG004|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916753|NCT00642278|OG005|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
10916754|NCT00642278|OG006|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916755|NCT00642278|EG000|Reported Event|Placebo|Each patient received matching placebo twice daily for 12 weeks.
10916756|NCT00642278|EG001|Reported Event|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916757|NCT00642278|EG002|Reported Event|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916758|NCT00642278|EG003|Reported Event|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916759|NCT00642278|EG004|Reported Event|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916760|NCT00642278|EG005|Reported Event|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
11174562|NCT02023125|FG001|Participant Flow|Group 1: Treatment B First, Then Treatment A|Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered. Each period was separated by at least 10 days.
10916761|NCT00642278|EG006|Reported Event|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
10916762|NCT00642304|BG000|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
10916763|NCT00642304|FG000|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels.
10916764|NCT00642304|OG000|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
10916765|NCT00642304|EG000|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
10916766|NCT00642356|BG000|Baseline|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
11234024|NCT02431806|BG000|Baseline|Placebo|Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
10916767|NCT00642356|BG001|Baseline|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
10916768|NCT00642356|BG002|Baseline|Total|Total of all reporting groups
10916769|NCT00642356|FG000|Participant Flow|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
10916770|NCT00642356|FG001|Participant Flow|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
10916771|NCT00642356|OG000|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
10916772|NCT00642356|OG001|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
10916773|NCT00642356|EG000|Reported Event|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
10916774|NCT00642356|EG001|Reported Event|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
10916775|NCT00642369|BG000|Baseline|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
10916776|NCT00642369|BG001|Baseline|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
10916777|NCT00642369|BG002|Baseline|Total|Total of all reporting groups
10916778|NCT00642369|FG000|Participant Flow|Quetiapine Fumarate|slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group
10916779|NCT00642369|FG001|Participant Flow|Haloperidol|slow wave sleep% in haloperidol treatment group
10916780|NCT00642369|OG000|Outcome|Quetiapine Fumarate|percentage of slow wave sleep in quetiapine fumarate group
10916781|NCT00642369|OG001|Outcome|Haloperidol|percentage of slow wave sleep in haloperidol group
10916782|NCT00642369|OG000|Outcome|Quetiapine Fumarate|percentage of rapid eye movement sleep in quetiapine fumarate group
10916783|NCT00642369|OG001|Outcome|Haloperidol|percentage of rapid eye movement sleep in haloperidol group
10916784|NCT00642369|EG000|Reported Event|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
10916785|NCT00642369|EG001|Reported Event|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
11174563|NCT02023125|FG002|Participant Flow|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
11174564|NCT02023125|OG000|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
11174565|NCT02023125|OG001|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
11174566|NCT02023125|OG000|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
11174567|NCT02023125|OG001|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
11234025|NCT02431806|BG001|Baseline|Levomilnacipran 40 mg/Day|Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
10916786|NCT00642460|BG000|Baseline|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
10916787|NCT00642460|BG001|Baseline|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
10916788|NCT00642460|BG002|Baseline|Total|Total of all reporting groups
10916789|NCT00642460|FG000|Participant Flow|Tocilizumab_8 mg/kg|"Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
10916790|NCT00642460|FG001|Participant Flow|Tocilizumab_12 mg/kg|"Tocilizumab 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
10916791|NCT00642460|FG002|Participant Flow|Placebo|Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
10916792|NCT00642460|FG003|Participant Flow|Tocilizumab Switchers|"Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
10916793|NCT00642460|FG004|Participant Flow|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
10916794|NCT00642460|FG005|Participant Flow|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
10916795|NCT00642460|OG000|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
10916796|NCT00642460|OG001|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
11174568|NCT02023125|OG001|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Day 16): Participants started the standardized meal 30 minutes prior to administration of alectinib. Participants were to consume this meal in 30 minutes or less. A single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Period 2 (Days 11 to 20): From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40-mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal.
11174569|NCT02023125|EG000|Reported Event|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
10916797|NCT00642460|OG000|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
11174570|NCT02023125|EG001|Reported Event|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
11174571|NCT02023125|EG002|Reported Event|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
11174572|NCT02023125|EG003|Reported Event|Group 2: Period 2 (Esomeprazole Alone)|Period 2: From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast.
11174573|NCT02023125|EG004|Reported Event|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
11174574|NCT02023151|BG000|Baseline|Omalizumab|"Active~Omalizumab"
11174575|NCT02023151|FG000|Participant Flow|Omalizumab|"Active~Omalizumab"
11174576|NCT02023151|OG000|Outcome|Omalizumab|"Active~Omalizumab"
11174577|NCT02023151|EG000|Reported Event|Omalizumab|"Active~Omalizumab"
11174578|NCT02023242|BG000|Baseline|Hydrus Microstent|Subjects underwent 1 Hydrus implantation
11174579|NCT02023242|BG001|Baseline|iStent Trabecular Micro Bypass|Subjects underwent 2 iStents implantation
11174580|NCT02023242|BG002|Baseline|Total|Total of all reporting groups
11174581|NCT02023242|FG000|Participant Flow|Hydrus Microstent|Subjects underwent 1 Hydrus implantation
11174582|NCT02023242|FG001|Participant Flow|iStent Trabecular Micro Bypass|Subjects underwent 2 iStents implantation
11174583|NCT02023242|OG000|Outcome|Hydrus Microstent|Subjects underwent 1 Hydrus implantation
11174584|NCT02023242|OG001|Outcome|iStent Trabecular Micro Bypass|Subjects underwent 2 iStents implantation
11174585|NCT02023242|EG000|Reported Event|Hydrus Microstent|Subjects underwent 1 Hydrus implantation
11174586|NCT02023242|EG001|Reported Event|iStent Trabecular Micro Bypass|Subjects underwent 2 iStents implantation
11174587|NCT02023268|BG000|Baseline|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
11174588|NCT02023268|BG001|Baseline|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
11174589|NCT02023268|BG002|Baseline|Total|Total of all reporting groups
11174590|NCT02023268|FG000|Participant Flow|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
10916798|NCT00642460|OG000|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
11174591|NCT02023268|FG001|Participant Flow|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
11174592|NCT02023268|OG000|Outcome|T2762|T2762: drop in each eye 3 to 6 times daily during 84 days
11174593|NCT02023268|OG001|Outcome|Vismed|Vismed : 1 drop in each eye 3 to 6 times daily during 84 days
11174594|NCT02023268|EG000|Reported Event|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
11174595|NCT02023268|EG001|Reported Event|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
11174596|NCT02023411|BG000|Baseline|Intervention Arm|Teriparatide 20 microgram administered Subcutanoeous daily
11174597|NCT02023411|BG001|Baseline|Placebo|Normal saline administered Subcutanoeous daily
11174598|NCT02023411|BG002|Baseline|Total|Total of all reporting groups
11174599|NCT02023411|FG000|Participant Flow|Teriparatide|Intervention Arm
11174600|NCT02023411|FG001|Participant Flow|Placebo|Normal saline will be subcutaneously administered at 8 pm daily
11174601|NCT02023411|OG000|Outcome|Teriparatide|Intervention arm
11174602|NCT02023411|OG001|Outcome|Placebo|Normal saline subcutaneous injection
10916799|NCT00642460|OG000|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
10916800|NCT00642460|OG001|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
10916801|NCT00642460|OG000|Outcome|All Participants Treated With Tocilizumab|"Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
10916802|NCT00642460|EG000|Reported Event|All Tocilizumab (Part I, Part II and Part III)|Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
10916803|NCT00642473|BG000|Baseline|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
10916804|NCT00642473|BG001|Baseline|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
10916805|NCT00642473|BG002|Baseline|Total|Total of all reporting groups
10916806|NCT00642473|FG000|Participant Flow|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 milligrams (mg) orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
10916807|NCT00642473|FG001|Participant Flow|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
10916808|NCT00642473|OG000|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash .
10916809|NCT00642473|OG001|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
10916810|NCT00642473|OG002|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
10916811|NCT00642473|OG003|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
10916812|NCT00642473|OG000|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash.
10916813|NCT00642473|EG000|Reported Event|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
10963140|NCT00870467|OG000|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
11174603|NCT02023411|OG001|Outcome|Placebo|Placebo normal saline was given
11174604|NCT02023411|EG000|Reported Event|Teriparatide|"10 diabetic patients with inactive Charcot's foot who are calcium and Vit.D sufficient will receive 20 microgram of teriparatide , subcutaneously between 8-9 p.m., daily.~Teriparatide: recombinant human parathyroid hormone (1-34) subcutaneously every day at 8-9 pm"
11174605|NCT02023411|EG001|Reported Event|Placebo|"10 diabetic patients with inactive Charcot's foot who are calcium and Vit.D sufficient will receive placebo , subcutaneously between 8-9 p.m. , daily.~Placebo: Placebo"
10916814|NCT00642473|EG001|Reported Event|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
10916815|NCT00642616|BG000|Baseline|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with Asthma
10916816|NCT00642616|BG001|Baseline|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
10916817|NCT00642616|BG002|Baseline|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with COPD
10916818|NCT00642616|BG003|Baseline|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD.
10916819|NCT00642616|BG004|Baseline|Total|Total of all reporting groups
10916820|NCT00642616|FG000|Participant Flow|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
10916821|NCT00642616|FG001|Participant Flow|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
10916822|NCT00642616|FG002|Participant Flow|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
10916823|NCT00642616|FG003|Participant Flow|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
10916824|NCT00642616|OG000|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
10916825|NCT00642616|OG001|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
10916826|NCT00642616|OG002|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
10916827|NCT00642616|OG003|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
10916828|NCT00642616|OG001|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
10916829|NCT00642616|OG003|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
10916830|NCT00642616|EG000|Reported Event|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
10916831|NCT00642616|EG001|Reported Event|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
10916832|NCT00642616|EG002|Reported Event|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
10916833|NCT00642616|EG003|Reported Event|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
10916834|NCT00642642|BG000|Baseline|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
10916835|NCT00642642|FG000|Participant Flow|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
10916836|NCT00642642|OG000|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
10916837|NCT00642642|OG001|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
10916838|NCT00642642|OG000|Outcome|Autologous Fibroblast Cheeks|Cheeks treated with autologous fibroblasts
10916839|NCT00642642|OG000|Outcome|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
10916840|NCT00642642|OG001|Outcome|Placebo Cheeks|Cheeks randomized to receive placebo treatment
10916841|NCT00642642|EG000|Reported Event|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
10916842|NCT00642642|EG001|Reported Event|Placebo Cheeks|Cheeks randomized to receive placebo treatment
10916843|NCT00642642|EG002|Reported Event|Non-treatment Area Adverse Events|Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group
10916844|NCT00642668|BG000|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
10916845|NCT00642668|FG000|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
10916846|NCT00642668|OG000|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
10916847|NCT00642668|EG000|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
10916848|NCT00642694|BG000|Baseline|Escitalopram + Ramelteon|active augmentation
10916849|NCT00642694|BG001|Baseline|Escitalopram + Placebo|Placebo augmentation
10916850|NCT00642694|BG002|Baseline|Total|Total of all reporting groups
10916851|NCT00642694|FG000|Participant Flow|Escitalopram + Ramelteon|active augmentation
11174606|NCT02023515|BG000|Baseline|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
11174607|NCT02023515|BG001|Baseline|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
11174608|NCT02023515|BG002|Baseline|Total|Total of all reporting groups
10916852|NCT00642694|FG001|Participant Flow|Escitalopram + Placebo|Placebo augmentation
10916853|NCT00642694|OG000|Outcome|Escitalopram + Ramelteon|active augmentation
10916854|NCT00642694|OG001|Outcome|Escitalopram + Placebo|control group
10916855|NCT00642694|EG000|Reported Event|Escitalopram + Ramelteon|active augmentation
10916856|NCT00642694|EG001|Reported Event|Escitalopram + Placebo|Placebo augmentation
10916857|NCT00642707|BG000|Baseline|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
10916858|NCT00642707|BG001|Baseline|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
10916859|NCT00642707|BG002|Baseline|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
10916860|NCT00642707|BG003|Baseline|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
10916861|NCT00642707|BG004|Baseline|Total|Total of all reporting groups
10916862|NCT00642707|FG000|Participant Flow|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
11174609|NCT02023515|FG000|Participant Flow|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
11174610|NCT02023515|FG001|Participant Flow|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
11174611|NCT02023515|OG000|Outcome|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
10916863|NCT00642707|FG001|Participant Flow|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
10916864|NCT00642707|FG002|Participant Flow|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
10916865|NCT00642707|FG003|Participant Flow|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
10916866|NCT00642707|OG000|Outcome|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
10916867|NCT00642707|OG001|Outcome|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
10916868|NCT00642707|OG002|Outcome|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
10916869|NCT00642707|OG003|Outcome|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
10916870|NCT00642707|EG000|Reported Event|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
10916871|NCT00642707|EG001|Reported Event|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
10916872|NCT00642707|EG002|Reported Event|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
10916873|NCT00642707|EG003|Reported Event|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
10963141|NCT00870467|OG001|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
10963142|NCT00870467|OG002|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
10963143|NCT00870467|OG003|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
10963144|NCT00870467|OG000|Outcome|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
10963145|NCT00870467|EG000|Reported Event|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
10963146|NCT00870467|EG001|Reported Event|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
10963147|NCT00870467|EG002|Reported Event|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
11174612|NCT02023515|OG001|Outcome|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
10916874|NCT00642746|BG000|Baseline|FOLFIRI With Erlotinib|
10916875|NCT00642746|BG001|Baseline|FOLFOX With Erlotinib|
10916876|NCT00642746|BG002|Baseline|Total|Total of all reporting groups
10916877|NCT00642746|FG000|Participant Flow|FOLFIRI With Erlotinib|
10916878|NCT00642746|FG001|Participant Flow|FOLFOX With Erlotinib|
10916879|NCT00642746|OG000|Outcome|FOLFIRI With Erlotinib|
10916880|NCT00642746|OG001|Outcome|FOLFOX With Erlotinib|
10916881|NCT00642746|EG000|Reported Event|FOLFIRI With Erlotinib|
10916882|NCT00642746|EG001|Reported Event|FOLFOX With Erlotinib|
10916883|NCT00642759|BG000|Baseline|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
10916884|NCT00642759|FG000|Participant Flow|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
10916885|NCT00642759|OG000|Outcome|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
10916886|NCT00642759|OG000|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab~carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab: IV infusion"
10916887|NCT00642759|EG000|Reported Event|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
10916888|NCT00642772|BG000|Baseline|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
10916889|NCT00642772|FG000|Participant Flow|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
10916890|NCT00642772|OG000|Outcome|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
10916891|NCT00642772|EG000|Reported Event|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
10916892|NCT00642811|BG000|Baseline|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916893|NCT00642811|BG001|Baseline|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916894|NCT00642811|BG002|Baseline|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916895|NCT00642811|BG003|Baseline|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916896|NCT00642811|BG004|Baseline|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916897|NCT00642811|BG005|Baseline|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916898|NCT00642811|BG006|Baseline|Total|Total of all reporting groups
10916899|NCT00642811|FG000|Participant Flow|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
10916900|NCT00642811|FG001|Participant Flow|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
10916901|NCT00642811|FG002|Participant Flow|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; stay on clopidogrel 75 mg once daily (od) for 2 weeks
10916902|NCT00642811|FG003|Participant Flow|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
10916903|NCT00642811|FG004|Participant Flow|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
10916904|NCT00642811|FG005|Participant Flow|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; stay on ticagrelor 90 mg twice daily (bd) for 2 weeks.
10916905|NCT00642811|OG000|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916906|NCT00642811|OG001|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916907|NCT00642811|OG000|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916908|NCT00642811|OG001|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
10916909|NCT00642811|EG000|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Ticagrelor|included non-responders exposed to ticagrelor on Day 1-14, Day 16-28.
10916910|NCT00642811|EG001|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Clopidogrel|included non-responders exposed to clopidogrel on Day 1-14, Day 16-28.
11174613|NCT02023515|EG000|Reported Event|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
11174614|NCT02023515|EG001|Reported Event|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
10916911|NCT00642811|EG002|Reported Event|Clop. Non-Responders/Switching Period:Ticagrelor-Clopidogrel|included non-responders exposed to ticagrelor switching to clopidogrel on Day 15.
10916912|NCT00642811|EG003|Reported Event|Clop. Non-Responders/Switching Period: Clopidogrel-Ticagrelor|included non-responders exposed to clopidogrel switching to ticagrelor on Day 15.
10916913|NCT00642811|EG004|Reported Event|Clop. Responders/Non-Switching Period: Ticagrelor|included responders exposed to ticagrelor on Day 1-14, Day 16-28.
10916914|NCT00642811|EG005|Reported Event|Clop. Responders/Non-Switching Period: Clopidogrel|included responders exposed to clopidogrel on Day 1-14, Day 16-28.
10916915|NCT00642811|EG006|Reported Event|Clop. Responders/Switching Period: Ticagrelor-Clopidogrel|included responders exposed to ticagrelor switching to clopidogrel on Day 15.
10916916|NCT00642811|EG007|Reported Event|Clop. Responders/Switching Period: Clopidogrel-Ticagrelor|included responders exposed to clopidogrel switching to ticagrelor on Day 15.
10916917|NCT00642850|BG000|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
10916918|NCT00642850|FG000|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
10916919|NCT00642850|OG000|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
10916920|NCT00642850|EG000|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
10916921|NCT00642902|BG000|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
10916922|NCT00642902|BG001|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
10916923|NCT00642902|BG002|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
10916924|NCT00642902|BG003|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
10916925|NCT00642902|BG004|Baseline|Total|Total of all reporting groups
10916926|NCT00642902|FG000|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
10916927|NCT00642902|FG001|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
10916928|NCT00642902|FG002|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
10916929|NCT00642902|FG003|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
10916930|NCT00642902|OG000|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
10916931|NCT00642902|OG001|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
10916932|NCT00642902|OG002|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
10916933|NCT00642902|OG003|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
10916934|NCT00642902|EG000|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
10916935|NCT00642902|EG001|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
10916936|NCT00642902|EG002|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
10916937|NCT00642902|EG003|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
11174615|NCT02023697|BG000|Baseline|Radium-223 Dichloride 55 kBq/kg, 6 Doses (Arm A)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride (Xofigo, BAY88-8223) 55 kBq/kg intravenously (IV) every 28 days for up to 6 doses (standard dose). Participants who discontinued study treatment and who did not have an SSE entered an active follow-up period with clinic visits. Participants from the treatment period or the active follow-up period with clinic visits who could no longer travel entered an active follow-up period without clinic visits. All study participants eligible for further follow-up were either in this study or in a separate long term follow-up study for up to 7 years."
10916938|NCT00642941|BG000|Baseline|Cohort 1: Ewings Sarcoma Primary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
10916939|NCT00642941|BG001|Baseline|Cohort 2: Ewings Sarcoma Secondary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
10916940|NCT00642941|BG002|Baseline|Cohort 3: Ewings Sarcoma Expanded Cohort|Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
10916941|NCT00642941|BG003|Baseline|Cohort 4: Osteosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
10916942|NCT00642941|BG004|Baseline|Cohort 5: Synovial Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
10916943|NCT00642941|BG005|Baseline|Cohort 6: Rhabdomyosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
10916944|NCT00642941|BG006|Baseline|Cohort 7a: Alveolar Soft Part Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
10916945|NCT00642941|BG007|Baseline|Cohort 7b: Desmoplastic Small Round Cell Tumors.|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
10916946|NCT00642941|BG008|Baseline|Cohort 7c: Extraskeletal Myxoid Chondrosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
10916947|NCT00642941|BG009|Baseline|Cohort 7d: Clear Cell Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
10916948|NCT00642941|BG010|Baseline|Cohort 7e: Myxoid Liposarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
10916949|NCT00642941|BG011|Baseline|Cohort 8: Diagnosis Not Specified|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
10916950|NCT00642941|BG012|Baseline|Total|Total of all reporting groups
10916951|NCT00642941|FG000|Participant Flow|Cohort 1: Ewings Sarcoma Primary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
10916952|NCT00642941|FG001|Participant Flow|Cohort 2: Ewings Sarcoma Secondary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
10916953|NCT00642941|FG002|Participant Flow|Cohort 3: Ewings Sarcoma Expanded Cohort|Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
10916954|NCT00642941|FG003|Participant Flow|Cohort 4: Osteosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
10916955|NCT00642941|FG004|Participant Flow|Cohort 5: Synovial Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
10916956|NCT00642941|FG005|Participant Flow|Cohort 6: Rhabdomyosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
10916957|NCT00642941|FG006|Participant Flow|Cohort 7a: Alveolar Soft Part Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
10916958|NCT00642941|FG007|Participant Flow|Cohort 7b: Desmoplastic Small Round Cell Tumors.|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
10916959|NCT00642941|FG008|Participant Flow|Cohort 7c: Extraskeletal Myxoid Chondrosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
11174616|NCT02023697|BG001|Baseline|Radium-223 Dichloride 88 kBq/kg, 6 Doses (Arm B)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride (Xofigo, BAY88-8223) 88 kBq/kg IV every 28 days for up to 6 doses (high dose). Participants who discontinued study treatment and who did not have an SSE entered an active follow-up period with clinic visits. Participants from the treatment period or the active follow-up period with clinic visits who could no longer travel entered an active follow-up period without clinic visits. All study participants eligible for further follow-up were either in this study or in a separate long term follow-up study for up to 7 years."
10916960|NCT00642941|FG009|Participant Flow|Cohort 7d: Clear Cell Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
10916961|NCT00642941|FG010|Participant Flow|Cohort 7e: Myxoid Liposarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
10916962|NCT00642941|FG011|Participant Flow|Cohort 8: Diagnosis Not Specified|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
10916963|NCT00642941|OG000|Outcome|Cohort 2: Ewings Sarcoma Secondary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
10916964|NCT00642941|OG001|Outcome|Cohort 3: Ewings Sarcoma Expanded Cohort|Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
10916965|NCT00642941|OG002|Outcome|Cohort 4: Osteosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
10916966|NCT00642941|OG003|Outcome|Cohort 5: Synovial Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
10916967|NCT00642941|OG004|Outcome|Cohort 6: Rhabdomyosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
10916968|NCT00642941|OG005|Outcome|Cohort 7a: Alveolar Soft Part Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
10916969|NCT00642941|OG006|Outcome|Cohort 7b: Desmoplastic Small Round Cell Tumors.|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
10916970|NCT00642941|OG007|Outcome|Cohort 7c: Extraskeletal Myxoid Chondrosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
10916971|NCT00642941|OG008|Outcome|Cohort 7d: Clear Cell Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
10916972|NCT00642941|OG009|Outcome|Cohort 7e: Myxoid Liposarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
10916973|NCT00642941|OG010|Outcome|Cohort 8: Diagnosis Not Specified|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
10916974|NCT00642941|OG000|Outcome|Cohort 1: Ewings Sarcoma Primary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
10916975|NCT00642941|OG001|Outcome|Cohort 2: Ewings Sarcoma Secondary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
10916976|NCT00642941|OG008|Outcome|Cohort 7e: Myxoid Liposarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
10916977|NCT00642941|OG009|Outcome|Cohort 7d: Clear Cell Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
10916978|NCT00642941|OG000|Outcome|Cohort 3: Ewings Sarcoma Expanded Cohort|Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
10916979|NCT00642941|OG001|Outcome|Cohort 4: Osteosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
10916980|NCT00642941|OG002|Outcome|Cohort 5: Synovial Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
10916981|NCT00642941|OG003|Outcome|Cohort 6: Rhabdomyosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
10916982|NCT00642941|OG004|Outcome|Cohort 7a: Alveolar Soft Part Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
10916983|NCT00642941|OG005|Outcome|Cohort 7b: Desmoplastic Small Round Cell Tumors.|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
10916984|NCT00642941|OG006|Outcome|Cohort 7c: Extraskeletal Myxoid Chondrosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
10916985|NCT00642941|OG007|Outcome|Cohort 7d: Clear Cell Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
10916986|NCT00642941|OG009|Outcome|Cohort 8: Diagnosis Not Specified|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
10916987|NCT00642941|OG002|Outcome|Cohort 3: Ewings Sarcoma Expanded Cohort|Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
10916988|NCT00642941|OG003|Outcome|Cohort 4: Osteosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
10916989|NCT00642941|OG004|Outcome|Cohort 5: Synovial Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
10916990|NCT00642941|OG005|Outcome|Cohort 6: Rhabdomyosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
10964031|NCT00875550|FG000|Participant Flow|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
10916991|NCT00642941|OG006|Outcome|Cohort 7a: Alveolar Soft Part Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
10916992|NCT00642941|OG007|Outcome|Cohort 7b: Desmoplastic Small Round Cell Tumors.|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
10916993|NCT00642941|OG008|Outcome|Cohort 7c: Extraskeletal Myxoid Chondrosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
10916994|NCT00642941|OG010|Outcome|Cohort 7e: Myxoid Liposarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
10916995|NCT00642941|OG011|Outcome|Cohort 8: Diagnosis Not Specified|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
10916996|NCT00642941|EG000|Reported Event|Cohort 1: Ewings Sarcoma Primary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
10916997|NCT00642941|EG001|Reported Event|Cohort 2: Ewings Sarcoma Secondary Cohort|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
10916998|NCT00642941|EG002|Reported Event|Cohort 3: Ewings Sarcoma Expanded Cohort|Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
10916999|NCT00642941|EG003|Reported Event|Cohort 4: Osteosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
10917000|NCT00642941|EG004|Reported Event|Cohort 5: Synovial Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
10917001|NCT00642941|EG005|Reported Event|Cohort 6: Rhabdomyosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
10917002|NCT00642941|EG006|Reported Event|Cohort 7a: Alveolar Soft Part Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
10917003|NCT00642941|EG007|Reported Event|Cohort 7b: Desmoplastic Small Round Cell Tumors|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
10917004|NCT00642941|EG008|Reported Event|Cohort 7c: Extraskeletal Myxoid Chondrosarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
10917005|NCT00642941|EG009|Reported Event|Cohort 7d: Clear Cell Sarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
10917006|NCT00642941|EG010|Reported Event|Cohort 7e: Myxoid Liposarcoma|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
10917007|NCT00642941|EG011|Reported Event|Cohort 8: Diagnosis Not Specified|Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
10917008|NCT00642954|BG000|Baseline|Level 1: Vorinostat 300 mg + Lenalidomide 10 mg|Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917009|NCT00642954|BG001|Baseline|Level 2: Vorinostat 400 mg + Lenalidomide 10 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917010|NCT00642954|BG002|Baseline|Level 3: Vorinostat 400 mg + Lenalidomide 15 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917011|NCT00642954|BG003|Baseline|Level 4: Vorinostat 400 mg + Lenalidomide 20 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917012|NCT00642954|BG004|Baseline|Level 5: Vorinostat 400 mg + Lenalidomide 25 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
10917013|NCT00642954|BG005|Baseline|Total|Total of all reporting groups
10917014|NCT00642954|FG000|Participant Flow|Level 1: Vorinostat 300 mg + Lenalidomide 10 mg|Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917015|NCT00642954|FG001|Participant Flow|Level 2: Vorinostat 400 mg + Lenalidomide 10 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917016|NCT00642954|FG002|Participant Flow|Level 3: Vorinostat 400 mg + Lenalidomide 15 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917017|NCT00642954|FG003|Participant Flow|Level 4: Vorinostat 400 mg + Lenalidomide 20 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917018|NCT00642954|FG004|Participant Flow|Level 5: Vorinostat 400 mg + Lenalidomide 25 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
10917019|NCT00642954|OG000|Outcome|Level 1: Vorinostat 300 mg + Lenalidomide 10 mg|Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917020|NCT00642954|OG001|Outcome|Level 2: Vorinostat 400 mg + Lenalidomide 10 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917021|NCT00642954|OG002|Outcome|Level 3: Vorinostat 400 mg + Lenalidomide 15 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
11234026|NCT02431806|BG002|Baseline|Levomilnacipran 80 mg/Day|Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
10917022|NCT00642954|OG003|Outcome|Level 4: Vorinostat 400 mg + Lenalidomide 20 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917023|NCT00642954|OG004|Outcome|Level 5: Vorinostat 400 mg + Lenalidomide 25 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
10917024|NCT00642954|EG000|Reported Event|Level 1: Vorinostat 300 mg + Lenalidomide 10 mg|Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917025|NCT00642954|EG001|Reported Event|Level 2: Vorinostat 400 mg + Lenalidomide 10 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917026|NCT00642954|EG002|Reported Event|Level 3: Vorinostat 400 mg + Lenalidomide 15 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917027|NCT00642954|EG003|Reported Event|Level 4: Vorinostat 400 mg + Lenalidomide 20 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
10917028|NCT00642954|EG004|Reported Event|Level 5: Vorinostat 400 mg + Lenalidomide 25 mg|Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
10917029|NCT00642993|BG000|Baseline|SCH 497079|SCH 497079, administered orally, once daily
10917030|NCT00642993|BG001|Baseline|Placebo|Placebo capsules, administered orally, once daily
10917031|NCT00642993|BG002|Baseline|Total|Total of all reporting groups
10917032|NCT00642993|FG000|Participant Flow|SCH 497079|SCH 497079, administered orally, once daily
10917033|NCT00642993|FG001|Participant Flow|Placebo|Placebo capsules, administered orally, once daily
10917034|NCT00642993|OG000|Outcome|SCH 497079|SCH 497079, administered orally, once daily
10917035|NCT00642993|OG001|Outcome|Placebo|Placebo capsules, administered orally, once daily
10917036|NCT00642993|EG000|Reported Event|SCH 497079|SCH 497079, administered orally, once daily
10917037|NCT00642993|EG001|Reported Event|Placebo|Placebo capsules, administered orally, once daily
10917038|NCT00643006|BG000|Baseline|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
11191854|NCT02134587|FG000|Participant Flow|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
10917039|NCT00643006|BG001|Baseline|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
10917040|NCT00643006|BG002|Baseline|Total|Total of all reporting groups
10917041|NCT00643006|FG000|Participant Flow|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
10917042|NCT00643006|FG001|Participant Flow|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
10917043|NCT00643006|OG000|Outcome|Arm A. Exercise|The intervention group participated in Nordic walking
10917044|NCT00643006|OG001|Outcome|Arm B. Active Comparator|The active comparison group participated in low-intensive walks.
10917045|NCT00643006|OG000|Outcome|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
10917046|NCT00643006|OG001|Outcome|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
10917047|NCT00643006|EG000|Reported Event|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
10917048|NCT00643006|EG001|Reported Event|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
10917049|NCT00643097|BG000|Baseline|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
10917050|NCT00643097|BG001|Baseline|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
10917051|NCT00643097|BG002|Baseline|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
10917052|NCT00643097|BG003|Baseline|Total|Total of all reporting groups
10917053|NCT00643097|FG000|Participant Flow|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
10917054|NCT00643097|FG001|Participant Flow|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
10917055|NCT00643097|FG002|Participant Flow|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
10917056|NCT00643097|OG000|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
10917057|NCT00643097|OG001|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
10917058|NCT00643097|OG002|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
10917059|NCT00643097|EG000|Reported Event|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
10917060|NCT00643097|EG001|Reported Event|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
10917061|NCT00643097|EG002|Reported Event|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
10917062|NCT00643123|BG000|Baseline|Allopurinol|Allopurinol: 300-600 mg/day over a 6 week period
10917063|NCT00643123|BG001|Baseline|Placebo|Placebo: Inactive substance
10917064|NCT00643123|BG002|Baseline|Total|Total of all reporting groups
10917065|NCT00643123|FG000|Participant Flow|Allopurinol|Allopurinol: 300-600 mg/day over a 6 week period
10917066|NCT00643123|FG001|Participant Flow|Placebo|Placebo: Inactive substance
10917067|NCT00643123|OG000|Outcome|Allopurinol|Allopurinol: 300-600 mg/day over a 6 week period
10917068|NCT00643123|OG001|Outcome|Placebo|Placebo: Inactive substance
10917069|NCT00643123|EG000|Reported Event|Placebo|Placebo: Inactive substance
10917070|NCT00643123|EG001|Reported Event|Allopurinol|Allopurinol: 300-600 mg/day over a 6 week period
10917071|NCT00643162|BG000|Baseline|Swedish Massage|"Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression.~Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants.~Massage: Massage twice a week, for 8 weeks."
10917072|NCT00643162|BG001|Baseline|Light-Touch|"Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression.~Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants.~Light touch: Light touch twice a week, for 8 weeks"
10917073|NCT00643162|BG002|Baseline|Total|Total of all reporting groups
10917074|NCT00643162|FG000|Participant Flow|Swedish Massage|"Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression.~Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants.~Massage: Massage twice a week, for 8 weeks."
10917075|NCT00643162|FG001|Participant Flow|Light-Touch|"Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression.~Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants.~Light touch: Light touch twice a week, for 8 weeks"
10917076|NCT00643162|OG000|Outcome|Swedish Massage|"Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression.~Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants.~Massage: Massage twice a week, for 8 weeks."
10917077|NCT00643162|OG001|Outcome|Light-Touch|"Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression.~Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants.~Light touch: Light touch twice a week, for 8 weeks"
10917078|NCT00643162|EG000|Reported Event|Swedish Massage|"Adding massage twice a week, for 8 weeks, and Lexapro in the treatment of depression.~Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants.~Massage: Massage twice a week, for 8 weeks."
10917079|NCT00643162|EG001|Reported Event|Light-Touch|"Adding light touch twice a week, for 8 weeks, and Lexapro in the treatment of depression.~Lexapro: 5mg-10mg of lexapro, daily, for 9 weeks for all study participants.~Light touch: Light touch twice a week, for 8 weeks"
10917080|NCT00643201|BG000|Baseline|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.~Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham International normalized ratio (INR) greater than, equal to ( ≥) 2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
10917081|NCT00643201|BG001|Baseline|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
10917082|NCT00643201|BG002|Baseline|Total|Total of all reporting groups
10917083|NCT00643201|FG000|Participant Flow|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.~Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham international normalized ratio (INR) greater than, equal to ( ≥) 2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
10917084|NCT00643201|FG001|Participant Flow|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.~Warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
10917085|NCT00643201|OG000|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
10917086|NCT00643201|OG001|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
10917087|NCT00643201|OG000|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
10917088|NCT00643201|OG000|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
10917089|NCT00643201|EG000|Reported Event|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
10917090|NCT00643201|EG001|Reported Event|Enoxaparin/Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
10917091|NCT00643279|BG000|Baseline|Treatment|Physicians have access to device-based hemodynamic monitor information to guide patient management
10917092|NCT00643279|BG001|Baseline|Control|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
10917093|NCT00643279|BG002|Baseline|Total|Total of all reporting groups
10917094|NCT00643279|FG000|Participant Flow|Treatment|Physicians have access to device-based hemodynamic monitor information to guide patient management
10917095|NCT00643279|FG001|Participant Flow|Control|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
11234027|NCT02431806|BG003|Baseline|Fluoxetine 20 mg/Day|Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
10917096|NCT00643279|OG000|Outcome|All Subjects With Attempted Implant|All subjects with an attempted implant of a Chronicle IHM.
10917097|NCT00643279|OG000|Outcome|All Subjects Successfully Implanted|All subjects successfully implanted with a Chronicle IHM system
10917098|NCT00643279|OG000|Outcome|Treatment|Physicians have access to device-based hemodynamic monitor information to guide patient management
10917099|NCT00643279|OG001|Outcome|Control|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
10917100|NCT00643279|EG000|Reported Event|Treatment|Physicians have access to device-based hemodynamic monitor information to guide patient management
10917101|NCT00643279|EG001|Reported Event|Control|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
10917102|NCT00643448|BG000|Baseline|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917103|NCT00643448|BG001|Baseline|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917104|NCT00643448|BG002|Baseline|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
10917105|NCT00643448|BG003|Baseline|Total|Total of all reporting groups
10917106|NCT00643448|FG000|Participant Flow|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917107|NCT00643448|FG001|Participant Flow|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917108|NCT00643448|FG002|Participant Flow|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
10917109|NCT00643448|OG000|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917110|NCT00643448|OG001|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
10917111|NCT00643448|OG000|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917112|NCT00643448|OG001|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917113|NCT00643448|OG002|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
10917114|NCT00643448|EG000|Reported Event|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917115|NCT00643448|EG001|Reported Event|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
10917116|NCT00643448|EG002|Reported Event|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
10917117|NCT00643487|BG000|Baseline|All Participants|No new arms or groups were associated with this observational study
10917118|NCT00643487|FG000|Participant Flow|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
10917119|NCT00643487|OG000|Outcome|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
10917120|NCT00643487|EG000|Reported Event|All Participants|observation of the behavior of the infrapatellar plica: Local anesthesia using bupivicaine will be initiated. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, will be injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization will be verified and the knee taken through a full range of passive and active exercises. Active quadriceps contraction in the subject will be performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP will be videotaped and recorded on lateral fluoroscopy.
10917121|NCT00643565|BG000|Baseline|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
10917122|NCT00643565|BG001|Baseline|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
10917123|NCT00643565|BG002|Baseline|Total|Total of all reporting groups
10917124|NCT00643565|FG000|Participant Flow|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
10917125|NCT00643565|FG001|Participant Flow|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
10964032|NCT00875550|FG001|Participant Flow|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
11174617|NCT02023697|BG002|Baseline|Radium-223 Dichloride 55 kBq/kg, 12 Doses (Arm C)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride (Xofigo, BAY88-8223) 55 kBq/kg IV every 28 days for up to 12 doses (extended dose). Participants who discontinued study treatment and who did not have an SSE entered an active follow-up period with clinic visits. Participants from the treatment period or the active follow-up period with clinic visits who could no longer travel entered an active follow-up period without clinic visits. All study participants eligible for further follow-up were either in this study or in a separate long term follow-up study for up to 7 years."
11174618|NCT02023697|BG003|Baseline|Total|Total of all reporting groups
11234028|NCT02431806|BG004|Baseline|Total|Total of all reporting groups
10917126|NCT00643565|OG000|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
10917127|NCT00643565|OG001|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
10917128|NCT00643565|OG000|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
10917129|NCT00643565|EG000|Reported Event|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
10917130|NCT00643565|EG001|Reported Event|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
10917131|NCT00643578|BG000|Baseline|All Participants|A single dose of 12 mcg and 24 mcg, on separate days, of formoterol were given.
10917132|NCT00643578|FG000|Participant Flow|Formoterol 12 First|a single dose of 12 mcg of formoterol was given first, then 24 mcg of formoterol
10917133|NCT00643578|FG001|Participant Flow|Formoterol 24 First|a single dose of 24 mcg of formoterol was given first, then 12 mcg of formoterol
10917134|NCT00643578|OG000|Outcome|12 Mcg Formoterol|low dose
11191855|NCT02134587|OG000|Outcome|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
10917135|NCT00643578|OG001|Outcome|24 Mcg Formoterol|high dose
10917136|NCT00643578|OG000|Outcome|12 Mcg of Formoterol|low dose
10917137|NCT00643578|OG001|Outcome|24 Mcg of Formoterol|high dose
10917138|NCT00643578|EG000|Reported Event|Formoterol 12|A single dose of 12 mcg of formoterol was administered.
10917139|NCT00643578|EG001|Reported Event|Formoterol 24|A single dose of 24 mcg of formoterol was administered.
10917140|NCT00643604|BG000|Baseline|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
10917141|NCT00643604|FG000|Participant Flow|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
10917142|NCT00643604|OG000|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
10917143|NCT00643604|EG000|Reported Event|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
10917144|NCT00643682|BG000|Baseline|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
10917145|NCT00643682|BG001|Baseline|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
10917146|NCT00643682|BG002|Baseline|Total|Total of all reporting groups
10917147|NCT00643682|FG000|Participant Flow|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
10917148|NCT00643682|FG001|Participant Flow|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
10917149|NCT00643682|OG000|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
10917150|NCT00643682|OG001|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
10917151|NCT00643682|EG000|Reported Event|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
10917152|NCT00643682|EG001|Reported Event|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
10917153|NCT00643760|BG000|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
10917154|NCT00643760|BG001|Baseline|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917155|NCT00643760|BG002|Baseline|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
11174619|NCT02023697|FG000|Participant Flow|Radium-223 Dichloride 55 kBq/kg, 6 Doses (Arm A)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride (Xofigo, BAY88-8223) 55 kBq/kg intravenously (IV) every 28 days for up to 6 doses (standard dose). Participants who discontinued study treatment and who did not have an SSE entered an active follow-up period with clinic visits. Participants from the treatment period or the active follow-up period with clinic visits who could no longer travel entered an active follow-up period without clinic visits. All study participants eligible for further follow-up were either in this study or in a separate long term follow-up study for up to 7 years."
11174620|NCT02023697|FG001|Participant Flow|Radium-223 Dichloride 88 kBq/kg, 6 Doses (Arm B)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride (Xofigo, BAY88-8223) 88 kBq/kg IV every 28 days for up to 6 doses (high dose). Participants who discontinued study treatment and who did not have an SSE entered an active follow-up period with clinic visits. Participants from the treatment period or the active follow-up period with clinic visits who could no longer travel entered an active follow-up period without clinic visits. All study participants eligible for further follow-up were either in this study or in a separate long term follow-up study for up to 7 years."
11174621|NCT02023697|FG002|Participant Flow|Radium-223 Dichloride 55 kBq/kg, 12 Doses (Arm C)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride (Xofigo, BAY88-8223) 55 kBq/kg IV every 28 days for up to 12 doses (extended dose). Participants who discontinued study treatment and who did not have an SSE entered an active follow-up period with clinic visits. Participants from the treatment period or the active follow-up period with clinic visits who could no longer travel entered an active follow-up period without clinic visits. All study participants eligible for further follow-up were either in this study or in a separate long term follow-up study for up to 7 years."
10917156|NCT00643760|BG003|Baseline|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917157|NCT00643760|BG004|Baseline|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
10917158|NCT00643760|BG005|Baseline|Total|Total of all reporting groups
10917159|NCT00643760|FG000|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
10917160|NCT00643760|FG001|Participant Flow|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917161|NCT00643760|FG002|Participant Flow|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917162|NCT00643760|FG003|Participant Flow|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917163|NCT00643760|FG004|Participant Flow|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
10917164|NCT00643760|OG000|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
10917165|NCT00643760|OG001|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917166|NCT00643760|OG002|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917167|NCT00643760|OG003|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917168|NCT00643760|OG004|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
10917169|NCT00643760|EG000|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
10917170|NCT00643760|EG001|Reported Event|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917171|NCT00643760|EG002|Reported Event|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917172|NCT00643760|EG003|Reported Event|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
10917173|NCT00643760|EG004|Reported Event|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
10917174|NCT00643851|BG000|Baseline|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
10917175|NCT00643851|BG001|Baseline|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
11174622|NCT02023697|OG000|Outcome|Radium-223 88 kBq/kg, 6 Doses (Arm B)|"Participants who were randomized in a 1:1:1 fashion received radium-223 dichloride 88 kBq/kg IV every 28 days for up to 6 doses (high dose)."
11174623|NCT02023697|OG001|Outcome|Pooled Radium-223 55 kBq/kg (Arms A and C)|Pooled Arms A and C, participants who were randomized in a 1:1:1 fashion received radium-223 dichloride 55 kBq/kg IV every 28 days for up to 6 and 12 doses, respectively.
11174624|NCT02023697|OG000|Outcome|Radium-223 55 kBq/kg, 6 Doses (Arm A)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride 55 kBq/kg IV every 28 days for up to 6 doses (standard dose)."
11174625|NCT02023697|OG001|Outcome|Radium-223 88 kBq/kg, 12 Doses (Arm C)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride 55 kBq/kg IV every 28 days for up to 12 doses (extended dose)."
10917176|NCT00643851|BG002|Baseline|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
10917177|NCT00643851|BG003|Baseline|Total|Total of all reporting groups
10917178|NCT00643851|FG000|Participant Flow|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
10917179|NCT00643851|FG001|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
11174626|NCT02023697|OG001|Outcome|Radium-223 88 kBq/kg, 6 Doses (Arm C)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride 55 kBq/kg IV every 28 days for up to 12 doses (extended dose)."
11174627|NCT02023697|OG001|Outcome|Radium-223 88 kBq/kg, 6 Doses (Arm B)|"Participants who were randomized in a 1:1:1 fashion received radium-223 dichloride 88 kBq/kg IV every 28 days for up to 6 doses (high dose)."
10917180|NCT00643851|FG002|Participant Flow|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
10917181|NCT00643851|OG000|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
10917182|NCT00643851|OG001|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
10917183|NCT00643851|OG002|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
10917184|NCT00643851|EG000|Reported Event|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
11174628|NCT02023697|OG002|Outcome|Radium-223 55 kBq/kg, 12 Doses (Arm C)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride 55 kBq/kg IV every 28 days for up to 12 doses (extended dose)."
11174629|NCT02023697|OG000|Outcome|Radium-223 Dichloride 55 kBq/kg, 6 Doses (Arm A)|"Participants who were randomized in a 1:1:1 fashion received Xofigo (Radium-223 dichloride, BAY88-8223) 55 kBq/kg intravenously (IV) every 28 days for up to 6 doses (standard dose)."
10917185|NCT00643851|EG001|Reported Event|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
10917186|NCT00643851|EG002|Reported Event|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
10917187|NCT00643916|BG000|Baseline|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
10917188|NCT00643916|BG001|Baseline|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
10917189|NCT00643916|BG002|Baseline|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
10917190|NCT00643916|BG003|Baseline|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
10917191|NCT00643916|BG004|Baseline|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
10917192|NCT00643916|BG005|Baseline|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
10917193|NCT00643916|BG006|Baseline|Total|Total of all reporting groups
10917194|NCT00643916|FG000|Participant Flow|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
10917195|NCT00643916|FG001|Participant Flow|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
10917196|NCT00643916|FG002|Participant Flow|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
10917197|NCT00643916|FG003|Participant Flow|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
10917198|NCT00643916|FG004|Participant Flow|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
10917199|NCT00643916|FG005|Participant Flow|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
10917200|NCT00643916|OG000|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
10917201|NCT00643916|OG001|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
10917202|NCT00643916|OG002|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
11174630|NCT02023697|OG001|Outcome|Radium-223 Dichloride 55 kBq/kg, 12 Doses (Arm C)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride 55 kBq/kg IV every 28 days for up to 12 doses (extended dose)."
11174631|NCT02023697|OG002|Outcome|Radium-223 Dichloride 55 kBq/kg, 12 Doses (Arm C)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride 55 kBq/kg IV every 28 days for up to 12 doses (extended dose)."
10917203|NCT00643916|OG003|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
10917204|NCT00643916|OG004|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
10917205|NCT00643916|OG005|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
10917206|NCT00643916|EG000|Reported Event|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
10917207|NCT00643916|EG001|Reported Event|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
10917208|NCT00643916|EG002|Reported Event|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
10917209|NCT00643916|EG003|Reported Event|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
10917210|NCT00643916|EG004|Reported Event|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
10917211|NCT00643916|EG005|Reported Event|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
10917212|NCT00644059|BG000|Baseline|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917213|NCT00644059|BG001|Baseline|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917214|NCT00644059|BG002|Baseline|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917215|NCT00644059|BG003|Baseline|Total|Total of all reporting groups
10917216|NCT00644059|FG000|Participant Flow|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917217|NCT00644059|FG001|Participant Flow|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917218|NCT00644059|FG002|Participant Flow|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine
10917219|NCT00644059|OG000|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
10917220|NCT00644059|OG001|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917221|NCT00644059|OG000|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917222|NCT00644059|OG001|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917223|NCT00644059|OG001|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917224|NCT00644059|OG002|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917225|NCT00644059|OG003|Outcome|Flu-control (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917226|NCT00644059|OG004|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917227|NCT00644059|OG005|Outcome|Non-Flu-control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917228|NCT00644059|OG001|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917229|NCT00644059|OG002|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917230|NCT00644059|OG003|Outcome|TIV-adj (6 to <72 Months )|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917231|NCT00644059|OG004|Outcome|Flu-control (6 to <72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917232|NCT00644059|OG005|Outcome|Non-Flu-control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917233|NCT00644059|OG000|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917234|NCT00644059|OG002|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917235|NCT00644059|OG003|Outcome|TIV-adj (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917236|NCT00644059|OG004|Outcome|Non-flu Control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917237|NCT00644059|OG005|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917238|NCT00644059|OG001|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917239|NCT00644059|OG002|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917240|NCT00644059|OG003|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917241|NCT00644059|OG004|Outcome|Non-flu Control (36 to < 72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917242|NCT00644059|OG000|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917243|NCT00644059|OG001|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917244|NCT00644059|OG002|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917245|NCT00644059|OG000|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
10917246|NCT00644059|OG002|Outcome|Flu-control (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
11174632|NCT02023697|EG000|Reported Event|Radium-223 55 kBq/kg Arm A (6 Doses)|"Participants who were randomized in a 1:1:1 fashion received Xofigo (Radium-223 dichloride, BAY88-8223) 55 kBq/kg intravenously (IV) every 28 days for up to 6 doses (standard dose)."
10917247|NCT00644059|OG003|Outcome|TIV-adj (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917248|NCT00644059|OG004|Outcome|Non-flu Control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917249|NCT00644059|OG005|Outcome|Flu Control (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917250|NCT00644059|OG001|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917251|NCT00644059|OG002|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917252|NCT00644059|OG000|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917253|NCT00644059|OG001|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917254|NCT00644059|OG002|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917255|NCT00644059|OG001|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917256|NCT00644059|OG000|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
10917257|NCT00644059|OG002|Outcome|Non-flu Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
10917258|NCT00644059|OG002|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917259|NCT00644059|OG002|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of
10917260|NCT00644059|EG000|Reported Event|TIV-adj_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
10917261|NCT00644059|EG001|Reported Event|TIV-adj_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
11174633|NCT02023697|EG001|Reported Event|Radium-223 88 kBq/kg Arm B (6 Doses)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride (Xofigo, BAY88-8223) 88 kBq/kg IV every 28 days for up to 6 doses (high dose)."
10917262|NCT00644059|EG002|Reported Event|Flu-control_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917263|NCT00644059|EG003|Reported Event|Flu-control_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
10917264|NCT00644059|EG004|Reported Event|Non-Flu-control (TBE/Men C Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917265|NCT00644059|EG005|Reported Event|Non-Flu-control (TBE Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
10917266|NCT00644189|BG000|Baseline|Clofarabine Phase I|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
10917267|NCT00644189|FG000|Participant Flow|Clofarabine 1 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
10917268|NCT00644189|FG001|Participant Flow|Clofarabine 2 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
10917269|NCT00644189|FG002|Participant Flow|Clofarabine 4 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
10917270|NCT00644189|FG003|Participant Flow|Clofarabine: 3 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
10917271|NCT00644189|OG000|Outcome|Phase I-II|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
10917272|NCT00644189|OG000|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
11174634|NCT02023697|EG002|Reported Event|Radium-223 55 kBq/kg Arm C (12 Doses)|"Participants who were randomized in a 1:1:1 fashion received Radium-223 dichloride (Xofigo, BAY88-8223) 55 kBq/kg IV every 28 days for up to 12 doses (extended dose)."
11174635|NCT02023801|BG000|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
10917273|NCT00644189|OG000|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
10917274|NCT00644189|EG000|Reported Event|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
10917275|NCT00644280|BG000|Baseline|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
10917276|NCT00644280|BG001|Baseline|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
10917277|NCT00644280|BG002|Baseline|Total|Total of all reporting groups
11174636|NCT02023801|FG000|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
10917278|NCT00644280|FG000|Participant Flow|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
10917279|NCT00644280|FG001|Participant Flow|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
10917280|NCT00644280|OG000|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
10917281|NCT00644280|OG001|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
10917282|NCT00644280|EG000|Reported Event|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
10917283|NCT00644280|EG001|Reported Event|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
10917284|NCT00644332|BG000|Baseline|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
10917285|NCT00644332|FG000|Participant Flow|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
10964033|NCT00875550|OG000|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
11174637|NCT02023801|OG000|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
11174638|NCT02023801|EG000|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
11191856|NCT02134587|OG001|Outcome|Subjects Prior to Educational Intervention|Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
10917286|NCT00644332|OG000|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
10917287|NCT00644332|EG000|Reported Event|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
10917288|NCT00644358|BG000|Baseline|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
10917289|NCT00644358|FG000|Participant Flow|Vilazodone|Vilazodone titrated up to 40 milligrams (mg)/day for 1 year.
10917290|NCT00644358|OG000|Outcome|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
10917291|NCT00644358|EG000|Reported Event|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
10917292|NCT00644423|BG000|Baseline|Omega-3 Fatty Acid|Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
10917293|NCT00644423|BG001|Baseline|Placebo|Placebo: Matching Placebo
10917294|NCT00644423|BG002|Baseline|Total|Total of all reporting groups
10917295|NCT00644423|FG000|Participant Flow|Omega-3 Fatty Acid|Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
10917296|NCT00644423|FG001|Participant Flow|Placebo|Placebo: Matching Placebo
11174639|NCT02023866|BG000|Baseline|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
11174640|NCT02023866|FG000|Participant Flow|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
10917297|NCT00644423|OG000|Outcome|Omega-3 Fatty Acid|Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
11174641|NCT02023866|OG000|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
10917298|NCT00644423|OG001|Outcome|Placebo|Placebo: Matching Placebo
10917299|NCT00644423|EG000|Reported Event|Omega-3 Fatty Acid|Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
10917300|NCT00644423|EG001|Reported Event|Placebo|Placebo: Matching Placebo
11174642|NCT02023866|EG000|Reported Event|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
11234029|NCT02431806|FG000|Participant Flow|Placebo|Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
10917301|NCT00644592|BG000|Baseline|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
10917302|NCT00644592|BG001|Baseline|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
10917303|NCT00644592|BG002|Baseline|Total|Total of all reporting groups
10917304|NCT00644592|FG000|Participant Flow|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
10917305|NCT00644592|FG001|Participant Flow|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
10917306|NCT00644592|OG000|Outcome|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
10917307|NCT00644592|OG001|Outcome|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
10917308|NCT00644592|EG000|Reported Event|1-Fenofibrate|4 weeks of drug at 160 mg orally per day
10917309|NCT00644592|EG001|Reported Event|2 Placebo|4 weeks of placebo.
10917310|NCT00644657|BG000|Baseline|Clopidogrel|All 27 subjects received a 300 mg loading dose of clopidogrel
10917311|NCT00644657|FG000|Participant Flow|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
10917312|NCT00644657|OG000|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
10917313|NCT00644657|EG000|Reported Event|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
10917314|NCT00644787|BG000|Baseline|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
10917315|NCT00644787|FG000|Participant Flow|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
10917316|NCT00644787|FG001|Participant Flow|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
10917317|NCT00644787|FG002|Participant Flow|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
10917318|NCT00644787|OG000|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
10917319|NCT00644787|OG000|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
10917320|NCT00644787|OG001|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
10917321|NCT00644787|EG000|Reported Event|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
10917322|NCT00644787|EG001|Reported Event|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
10917323|NCT00644787|EG002|Reported Event|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
11174643|NCT02023879|BG000|Baseline|Placebo Q2W|"Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.~Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed."
11234030|NCT02431806|FG001|Participant Flow|Levomilnacipran 40 mg/Day|Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
10917324|NCT00644878|BG000|Baseline|Nilotinib|Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
10917325|NCT00644878|FG000|Participant Flow|Nilotinib|Participants orally received a total of 600 milligram (mg) dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules twice daily (BID) for 12 cycles (each cycle = 28 days).
10917326|NCT00644878|OG000|Outcome|Nilotinib|Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
10917327|NCT00644878|EG000|Reported Event|Nilotinib|Participants orally received a total of 600 mg dose of Nilotinib as a as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
10917328|NCT00644917|BG000|Baseline|Xenaderm vs. Vehicle - Subjects Acted as Own Comparator|Subjects received duplicate 20 mg applications of Xenaderm Ointment and Xenaderm vehicle contained in Finn Chambers, to the left sides of their backs
10917329|NCT00644917|FG000|Participant Flow|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
10917330|NCT00644917|OG000|Outcome|Xenaderm Ointment - Irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - then irradiated
10917331|NCT00644917|OG001|Outcome|Xenaderm Vehicle - Irradiated|20 mg sample of Vehicle applied in Finn Chamber to test site on the left side of each subject's back - then irradiated
10917332|NCT00644917|OG002|Outcome|Control - Irradiated|test site was covered with an empty Finn Chamber as a control site - then irradiated
10917333|NCT00644917|OG003|Outcome|Xenaderm Ointment - Non-irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
10917334|NCT00644917|OG004|Outcome|Xenaderm Vehicle - Non-irradiated|20 mg samples of Xenaderm Vehicle applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
10917335|NCT00644917|EG000|Reported Event|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
10917336|NCT00644969|BG000|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
10917337|NCT00644969|BG001|Baseline|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
10917338|NCT00644969|BG002|Baseline|Total|Total of all reporting groups
10917339|NCT00644969|FG000|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
10917340|NCT00644969|FG001|Participant Flow|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
10917341|NCT00644969|OG000|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
10917342|NCT00644969|OG001|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
10917343|NCT00644969|EG000|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
10917344|NCT00644969|EG001|Reported Event|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
10917345|NCT00644995|BG000|Baseline|Usual Care|Advice to quit smoking and referral to standard care
10917346|NCT00644995|BG001|Baseline|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity (PA)
10917347|NCT00644995|BG002|Baseline|Total|Total of all reporting groups
10917348|NCT00644995|FG000|Participant Flow|Usual Care|Advice to quit and referral to standard care
10917349|NCT00644995|FG001|Participant Flow|Step Up|proactive phone counseling addressing smoking, depression, and PA
10917350|NCT00644995|OG000|Outcome|Usual Care|Advice to quit and referral to standard care
10917351|NCT00644995|OG001|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and physical activity
10917352|NCT00644995|OG001|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and PA
10917353|NCT00644995|OG001|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
10917354|NCT00644995|EG000|Reported Event|Usual Care|Advice to quit and referral to standard care
10917355|NCT00644995|EG001|Reported Event|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity
10917356|NCT00645047|BG000|Baseline|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
10917357|NCT00645047|BG001|Baseline|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
10917358|NCT00645047|BG002|Baseline|Total|Total of all reporting groups
10917359|NCT00645047|FG000|Participant Flow|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
10917360|NCT00645047|FG001|Participant Flow|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
10917361|NCT00645047|OG000|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
10917362|NCT00645047|OG001|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
10917363|NCT00645047|EG000|Reported Event|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
10917364|NCT00645047|EG001|Reported Event|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
10917365|NCT00645099|BG000|Baseline|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
10917366|NCT00645099|BG001|Baseline|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
10917367|NCT00645099|BG002|Baseline|Total|Total of all reporting groups
10917368|NCT00645099|FG000|Participant Flow|Paliperidone Extended Release (ER)|6-mg or 9-mg tablet once daily flexible dosing for 6 months
10917369|NCT00645099|FG001|Participant Flow|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
10917370|NCT00645099|OG000|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
10917371|NCT00645099|OG001|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
10917372|NCT00645099|EG000|Reported Event|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
10917373|NCT00645099|EG001|Reported Event|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
10917374|NCT00645164|BG000|Baseline|Xenaderm|Subject serves as own control
10917375|NCT00645164|FG000|Participant Flow|Xenaderm|Subject serves as own control
10917376|NCT00645164|OG000|Outcome|Xenaderm|Subject serves as own control
10917377|NCT00645164|EG000|Reported Event|Xenaderm|Subject serves as own control
10917378|NCT00645333|BG000|Baseline|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
10917379|NCT00645333|FG000|Participant Flow|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
10917380|NCT00645333|OG000|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
10917381|NCT00645333|EG000|Reported Event|MK-0752|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
10917382|NCT00645411|BG000|Baseline|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
10917383|NCT00645411|BG001|Baseline|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
10917384|NCT00645411|BG002|Baseline|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
10917385|NCT00645411|BG003|Baseline|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
10917386|NCT00645411|BG004|Baseline|Total|Total of all reporting groups
10917387|NCT00645411|FG000|Participant Flow|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
10917388|NCT00645411|FG001|Participant Flow|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
10917389|NCT00645411|FG002|Participant Flow|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
10917390|NCT00645411|FG003|Participant Flow|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
10917391|NCT00645411|OG000|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
10917392|NCT00645411|OG001|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg - derived trivalent influenza vaccine.
10917393|NCT00645411|OG001|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
10917394|NCT00645411|OG000|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine
10917395|NCT00645411|OG001|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
10917396|NCT00645411|OG000|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
10917397|NCT00645411|OG000|Outcome|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
10917398|NCT00645411|OG001|Outcome|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
10917399|NCT00645411|OG001|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg- derived trivalent influenza vaccine.
10917400|NCT00645411|EG000|Reported Event|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
10917401|NCT00645411|EG001|Reported Event|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
10917402|NCT00645411|EG002|Reported Event|Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
10917403|NCT00645411|EG003|Reported Event|Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
10917404|NCT00645411|EG004|Reported Event|Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
10917405|NCT00645411|EG005|Reported Event|Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
10917406|NCT00645450|BG000|Baseline|Propranolol|Weekly doses of short and long acting propranolol following recollection of traumatic memory
10917407|NCT00645450|BG001|Baseline|Placebo|Weekly doses of placebo following recollection of traumatic memory
10917408|NCT00645450|BG002|Baseline|Total|Total of all reporting groups
10917409|NCT00645450|FG000|Participant Flow|Propranolol|Weekly doses of short and long acting propranolol following recollection of traumatic memory
10917410|NCT00645450|FG001|Participant Flow|Placebo|Weekly doses of placebo following recollection of traumatic memory
10917411|NCT00645450|OG000|Outcome|Propranolol|Weekly doses of short and long acting propranolol following recollection of traumatic memory
10917412|NCT00645450|OG001|Outcome|Placebo|Weekly doses of placebo following recollection of traumatic memory
10917413|NCT00645450|EG000|Reported Event|Propranolol|Weekly doses of short and long acting propranolol following recollection of traumatic memory
10917414|NCT00645450|EG001|Reported Event|Placebo|Weekly doses of placebo following recollection of traumatic memory
10917415|NCT00645528|BG000|Baseline|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
10917416|NCT00645528|FG000|Participant Flow|Insulin Education Class Participants|"Subjects attended two group visits, two weeks apart, during which they received education regarding goals of therapy, insulin use, and hypoglycemia. Self-monitored blood glucose values were reviewed and insulin was initiated, if felt appropriate by the physician investigator and if accepted by the subject. The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit.The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment.~Additionally, at the second visit, proportion of blood glucose readings below 70 mg/dl were recorded. All patients were asked how many times in the two weeks they experienced symptoms/signs of low blood sugar, how many times they required sugar intake for the these symptoms, and how many times they required another person to assist them."
10917417|NCT00645528|OG000|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
10917418|NCT00645528|EG000|Reported Event|Arm 1|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
10917419|NCT00645593|BG000|Baseline|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
10917420|NCT00645593|BG001|Baseline|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
10917421|NCT00645593|BG002|Baseline|Total|Total of all reporting groups
10917422|NCT00645593|FG000|Participant Flow|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
10917423|NCT00645593|FG001|Participant Flow|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
10917424|NCT00645593|OG000|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
10917425|NCT00645593|OG001|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
10917426|NCT00645593|EG000|Reported Event|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
10917427|NCT00645593|EG001|Reported Event|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
10917428|NCT00645671|BG000|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
10917429|NCT00645671|BG001|Baseline|Vehicle|Vehicle of loteprednol etabonate ointment
10917430|NCT00645671|BG002|Baseline|Total|Total of all reporting groups
10917431|NCT00645671|FG000|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
10917432|NCT00645671|FG001|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ointment
10917433|NCT00645671|OG000|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
10917434|NCT00645671|OG001|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
10917435|NCT00645671|EG000|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
10917436|NCT00645671|EG001|Reported Event|Vehicle|Vehicle of loteprednol etabonate ointment
10963148|NCT00870545|BG000|Baseline|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND~Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
10917437|NCT00645710|BG000|Baseline|Dose Level 1 - FUdR 0.10 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917438|NCT00645710|BG001|Baseline|Dose Level 2 - FUdR 0.15 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917439|NCT00645710|BG002|Baseline|Dose Level 3 - FUdR 0.20 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917440|NCT00645710|BG003|Baseline|Total|Total of all reporting groups
10917441|NCT00645710|FG000|Participant Flow|Dose Level 1- FUdR 0.10 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917442|NCT00645710|FG001|Participant Flow|Dose Level 2 - FUdR 0.15 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917443|NCT00645710|FG002|Participant Flow|Dose Level 3 - FUdR 0.20 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917444|NCT00645710|OG000|Outcome|Dose Level 1- FUdR 0.10 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
11174644|NCT02023879|BG001|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|"Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.~Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed."
11174645|NCT02023879|BG002|Baseline|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|"Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.~Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed."
11174646|NCT02023879|BG003|Baseline|Total|Total of all reporting groups
11174647|NCT02023879|FG000|Participant Flow|Placebo Q2W|"Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.~Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed."
11191857|NCT02134587|OG000|Outcome|Subjects Post Educational Intervention|"Knowledge of health professionals after multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
10917445|NCT00645710|OG001|Outcome|Dose Level 2 - FUdR 0.15 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917446|NCT00645710|OG002|Outcome|Dose Level 3 - FUdR 0.20 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917447|NCT00645710|OG000|Outcome|RIT/Gemcitabine/FUdR|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917448|NCT00645710|EG000|Reported Event|Dose Level 1- FUdR 0.10 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917449|NCT00645710|EG001|Reported Event|Dose Level 2- FUdR 0.15 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917450|NCT00645710|EG002|Reported Event|Dose Level 3- FUdR 0.20 mg/kg/Day|"Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician."
10917451|NCT00645762|BG000|Baseline|Balloon Dilation|
10917452|NCT00645762|FG000|Participant Flow|FinESS Sisnus System Balloon Dilation|Transantral balloon dilation ofthe maxillary sinuses with the FinESS Sinus System.
10917453|NCT00645762|OG000|Outcome|Treatment Group (ALL)|FinESS Balloon Dilation
10917454|NCT00645762|OG000|Outcome|FinESS Balloon Dilation|
10917455|NCT00645762|OG000|Outcome|FinESS Balloon Arm|Subjects completing 12 month post-procedure follow-up
10917456|NCT00645762|EG000|Reported Event|Treatment Group (ALL)|
10917457|NCT00645788|BG000|Baseline|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
10917458|NCT00645788|BG001|Baseline|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
10917459|NCT00645788|BG002|Baseline|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
10917460|NCT00645788|BG003|Baseline|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
10917461|NCT00645788|BG004|Baseline|Total|Total of all reporting groups
10917462|NCT00645788|FG000|Participant Flow|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
10917463|NCT00645788|FG001|Participant Flow|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
10917464|NCT00645788|FG002|Participant Flow|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
10917465|NCT00645788|FG003|Participant Flow|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
10917466|NCT00645788|OG000|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
10917467|NCT00645788|OG001|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
10917468|NCT00645788|OG002|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
10917469|NCT00645788|OG003|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
11191858|NCT02134587|OG001|Outcome|Subjects Prior to Educational Intervention|Knowledge of health professionals before the educational intervention regarding pharmacovigilance
10917470|NCT00645788|EG000|Reported Event|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
10917471|NCT00645788|EG001|Reported Event|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
10917472|NCT00645788|EG002|Reported Event|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
10917473|NCT00645788|EG003|Reported Event|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
10917474|NCT00645827|BG000|Baseline|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
10917475|NCT00645827|BG001|Baseline|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
10917476|NCT00645827|BG002|Baseline|Total|Total of all reporting groups
10917477|NCT00645827|FG000|Participant Flow|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
10917478|NCT00645827|FG001|Participant Flow|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
10917479|NCT00645827|OG000|Outcome|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
10917480|NCT00645827|OG001|Outcome|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
11234031|NCT02431806|FG002|Participant Flow|Levomilnacipran 80 mg/Day|Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
10917481|NCT00645827|EG000|Reported Event|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
10917482|NCT00645827|EG001|Reported Event|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
10917483|NCT00645840|BG000|Baseline|Anakinra|"Patients at Children's Medical Center Dallas between ages 6 and 18 years with Type 1 diabetes within one week of diagnosis were eligible.~Diabetes care. At diagnosis, all subjects were placed on a basal-bolus insulin regimen with glargine and either lispro or aspart. For the duration of the study, insulin doses were adjusted per standard clinic protocol with target glucose of 80-140 mg/dL fasting and 80-180 mg/dL before meals. At each study visit, we recorded the subject's current insulin doses and weight to allow calculation of the total daily dose (units/kg/day).~Anakinra. After study enrollment, all subjects started anakinra (Kineret; Amgen, Thousand Oaks, CA) as a subcutaneous daily injection. Subjects weighing more than 25 kg at the time of enrollment received 100 mg daily whereas those weighing 25 kg or less received 50 mg daily. Anakinra was continued for a total of 28 days with no dose adjustment."
10917484|NCT00645840|FG000|Participant Flow|Anakinra|Patients at Children's Medical Center Dallas between ages 6 and 18 yr with type 1 diabetes within 1 wk of diagnosis were eligible. Exclusion criteria included treatment with systemic or inhaled corticosteroids or any other immunomodulatory drug, active infection, history of mycobacterial disease, pregnancy, live vaccine administration within 90 d of enrollment, and severe comorbidities. Patients were excluded if it was uncertain whether they had type 1 or type 2 diabetes.
10917485|NCT00645840|OG000|Outcome|Anakinra|12 autoantibody positive subjects with newly diagnosed type 1 diabetes who were treated with anakinra
10917486|NCT00645840|EG000|Reported Event|Anakinra|Patients at Children's Medical Center Dallas between ages 6 and 18 yr with type 1 diabetes within 1 wk of diagnosis were eligible. Exclusion criteria included treatment with systemic or inhaled corticosteroids or any other immunomodulatory drug, active infection, history of mycobacterial disease, pregnancy, live vaccine administration within 90 d of enrollment, and severe comorbidities. Patients were excluded if it was uncertain whether they had type 1 or type 2 diabetes.
10917487|NCT00645853|BG000|Baseline|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
10917488|NCT00645853|BG001|Baseline|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
11234032|NCT02431806|FG003|Participant Flow|Fluoxetine 20 mg/Day|Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
10917489|NCT00645853|BG002|Baseline|Total|Total of all reporting groups
10917490|NCT00645853|FG000|Participant Flow|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
10917491|NCT00645853|FG001|Participant Flow|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
10917492|NCT00645853|OG000|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
10917493|NCT00645853|OG001|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
10917494|NCT00645853|EG000|Reported Event|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
10917495|NCT00645853|EG001|Reported Event|VKA INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
10917496|NCT00645944|BG000|Baseline|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
10917497|NCT00645944|BG001|Baseline|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
10917498|NCT00645944|BG002|Baseline|Total|Total of all reporting groups
10917499|NCT00645944|FG000|Participant Flow|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
10917500|NCT00645944|FG001|Participant Flow|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
10917501|NCT00645944|OG000|Outcome|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
10917502|NCT00645944|OG001|Outcome|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
11174648|NCT02023879|FG001|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|"Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.~Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed."
11174649|NCT02023879|FG002|Participant Flow|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|"Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.~Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed."
11174650|NCT02023879|OG000|Outcome|Placebo Q2W|Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
11174651|NCT02023879|OG001|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
11174652|NCT02023879|OG002|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
11174653|NCT02023879|OG001|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
11174654|NCT02023879|OG000|Outcome|Alirocumab 150 mg Q4W (After Placebo Q2W)|Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received placebo (for Alirocumab) Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
11174655|NCT02023879|OG001|Outcome|Alirocumab 150 mg QW4 (After Alirocumab 75 Q2W/Up 150 Q2W)|Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received Alirocumab 75 mg Q2W/Up to 150 mg Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
11174656|NCT02023879|OG002|Outcome|Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up 150 Q2W)|Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received 150 mg Q4W/Up to 150 mg Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
10917503|NCT00645944|EG000|Reported Event|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
10917504|NCT00645944|EG001|Reported Event|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
11174657|NCT02023879|EG000|Reported Event|Placebo Q2W|Participants exposed to placebo SC injection Q2W added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
11174658|NCT02023879|EG001|Reported Event|Alirocumab 75 mg Q2W/Up150 mg Q2W|Participants exposed to alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
11174659|NCT02023879|EG002|Reported Event|Alirocumab 150 mg Q4W/Up150 mg Q2W|Participants exposed to alirocumab 150 mg Q4W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 22 weeks).
11174660|NCT02023879|EG003|Reported Event|Alirocumab 150 mg Q4W (After Placebo Q2W)|Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 128 weeks) after having received Placebo Q2W for 24 weeks.
11174661|NCT02023879|EG004|Reported Event|Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)|Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 117 weeks) after having received Alirocumab 75 mg Q2W/Up to 150 mg Q2W for 24 weeks.
11174662|NCT02023879|EG005|Reported Event|Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)|Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 119 weeks) after having received Alirocumab 150 mg Q4W/Up to 150 mg Q2W for 24 weeks.
11174663|NCT02023918|BG000|Baseline|Pegvisomant Arm|pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
11174664|NCT02023918|FG000|Participant Flow|Pegvisomant Arm|"Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.~pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study."
11174665|NCT02023918|OG000|Outcome|Pegvisomant Arm|Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
11174666|NCT02023918|EG000|Reported Event|Pegvisomant Arm|pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
11174667|NCT02023944|BG000|Baseline|Intervention|"12-week course on aging~Memory and Aging Course: This is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older."
11174668|NCT02023944|BG001|Baseline|Control, No Intervention|"No Intervention, considered treatment as usual"
11174669|NCT02023944|BG002|Baseline|Total|Total of all reporting groups
11357564|NCT03756012|EG000|Reported Event|Total Patient Population|"This was a case series and all patients received both algorithms; pulse widths <500 µsec and >1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.~Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.~Adverse Events were not collected. Study was ended prematurely and results were only provided for total population instead of separate arms since subjects received both interventions."
11174670|NCT02023944|FG000|Participant Flow|Intervention|"12-week course on aging~Memory and Aging Course: This is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older."
11174671|NCT02023944|FG001|Participant Flow|Control, No Intervention|"No Intervention; considered treatment as usual"
11174672|NCT02023944|OG000|Outcome|Intervention|"12-week course on aging~Memory and Aging Course: This is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older."
11174673|NCT02023944|OG001|Outcome|Control, No Intervention|"No Intervention, considered treatment as usual"
11174674|NCT02023944|OG000|Outcome|Intervention|"12-week course on memory and aging~Memory and Aging Course: This is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older."
11174675|NCT02023944|EG000|Reported Event|Intervention|"12-week course on aging~Memory and Aging Course: This is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older."
11174676|NCT02023944|EG001|Reported Event|Control, No Intervention|"No Intervention, considered treatment as usual"
11174677|NCT02023983|BG000|Baseline|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
11357565|NCT03755882|BG000|Baseline|Total|All subjects dispensed a study lens
11174678|NCT02023983|BG001|Baseline|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
11174679|NCT02023983|BG002|Baseline|Total|Total of all reporting groups
11174680|NCT02023983|FG000|Participant Flow|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
11174681|NCT02023983|FG001|Participant Flow|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
11174682|NCT02023983|OG000|Outcome|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
11174683|NCT02023983|OG001|Outcome|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
11174684|NCT02023983|EG000|Reported Event|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
11174685|NCT02023983|EG001|Reported Event|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
11357566|NCT03755882|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
11174686|NCT02024087|BG000|Baseline|Dalantercept 0.6 mg/kg Plus Sorafenib 400 mg|Cohort 1: participants were administered dalantercept 0.6 mg/kg by subcutaneous injection once every 3 weeks plus sorafenib 400 mg orally once daily
11174687|NCT02024087|BG001|Baseline|Dalantercept 0.4 mg/kg Plus Sorafenib 400 mg|Cohort 2: participants were administered dalantercept 0.4 mg/kg by subcutaneous injection once every 3 weeks plus sorafenib 400 mg orally once daily
11174688|NCT02024087|BG002|Baseline|Total|Total of all reporting groups
11174689|NCT02024087|FG000|Participant Flow|Dalantercept 0.6 mg/kg Plus Sorafenib 400 mg|Cohort 1: Participants were administered dalantercept 0.6 mg/kg by subcutaneous injection once every 3 weeks and sorafenib 400 mg orally once daily
11174690|NCT02024087|FG001|Participant Flow|Dalantercept 0.4 mg/kg Plus Sorafenib 400 mg|Cohort 2: Participants were administered dalantercept 0.4 mg/kg by subcutaneous injection once every 3 weeks and sorafenib 400 mg orally once daily
11174691|NCT02024087|OG000|Outcome|Dalantercept 0.4 mg/kg Plus Sorafenib|Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
10917505|NCT00645970|BG000|Baseline|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
10917506|NCT00645970|BG001|Baseline|Registry|Participants recruited from the OEF/OIF/OND registry
10917507|NCT00645970|BG002|Baseline|Total|Total of all reporting groups
10917508|NCT00645970|FG000|Participant Flow|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
10917509|NCT00645970|FG001|Participant Flow|Registry|Participants recruited from the OEF/OIF/OND registry
11174692|NCT02024087|OG001|Outcome|Dalantercept 0.6 mg/kg Plus Sorafenib|Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
11174693|NCT02024087|OG001|Outcome|Dalantercept 0.6 mg/kg Plus Sorafenib|Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks
11174694|NCT02024087|EG000|Reported Event|Dalantercept 0.4 mg/kg Plus Sorafenib|Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
11174695|NCT02024087|EG001|Reported Event|Dalantercept 0.6 mg/kg Plus Sorafenib|Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
11174696|NCT02024165|BG000|Baseline|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and Ultrasound
11174697|NCT02024165|FG000|Participant Flow|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE and Ultrasound
11174698|NCT02024165|OG000|Outcome|Electrode Sensor, FSE|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE
11174699|NCT02024165|OG001|Outcome|Electrode Sensor, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or Ultrasound
11174700|NCT02024165|EG000|Reported Event|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and ultrasound
11174701|NCT02024204|BG000|Baseline|Visit 1 Uncontrolled LRS|"Patients who have uncontrolled LRS (ACT < 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.~Fluticasone propionate 230mcg for 3 Months~Salmeterol 21mcg for 3 Months"
11174702|NCT02024204|BG001|Baseline|Visit 1 Controlled LRS|"Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.~Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications."
11174703|NCT02024204|BG002|Baseline|Total|Total of all reporting groups
10917510|NCT00645970|OG000|Outcome|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
10917511|NCT00645970|OG001|Outcome|Registry|Participants recruited from the OEF/OIF/OND registry
10917512|NCT00645970|EG000|Reported Event|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
10917513|NCT00645970|EG001|Reported Event|Registry|Participants recruited from the OEF/OIF/OND registry
10917514|NCT00646048|BG000|Baseline|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
10917515|NCT00646048|FG000|Participant Flow|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
10917516|NCT00646048|OG000|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
10917517|NCT00646048|EG000|Reported Event|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
10917518|NCT00646113|BG000|Baseline|OsseoSpeed™ TX 3.0S|OsseoSpeed™ TX 3.0 mm diameter
10917519|NCT00646113|FG000|Participant Flow|OsseoSpeed™ TX 3.0|OsseoSpeed™ TX 3.0 mm diameter implants (lengths 11 mm, 13 mm and 15 mm).
10917520|NCT00646113|OG000|Outcome|OsseoSpeed™|OsseoSpeed™ TX 3.0 mm diameter
10917521|NCT00646113|EG000|Reported Event|OsseoSpeed™ TX 3.0S|OsseoSpeed™ TX 3.0 mm diameter
10917522|NCT00646399|BG000|Baseline|Pagibaximab|
10917523|NCT00646399|BG001|Baseline|Placebo|
10917524|NCT00646399|BG002|Baseline|Total|Total of all reporting groups
10917525|NCT00646399|FG000|Participant Flow|Pagibaximab|
10917526|NCT00646399|FG001|Participant Flow|Placebo|
10917527|NCT00646399|OG000|Outcome|Pagibaximab|
10917528|NCT00646399|OG001|Outcome|Placebo|
10917529|NCT00646399|EG000|Reported Event|Pagibaximab|
10917530|NCT00646399|EG001|Reported Event|Placebo|
10917531|NCT00646451|BG000|Baseline|All Participants|Demographics and clinical characteristics of participants at study initiation are listed in Table 1 of the paper. Sixteen of 20 patients completed the study and were included in the analysis of drug efficacy (Table 2).
10917532|NCT00646451|FG000|Participant Flow|Pregabalin First, Then Placebo|Pregabalin: 75 mg bid to 300 mg bid based on per subject tolerability. Study crossover design. Patients were randomized for treatment with PGB or placebo, titrated over 6 weeks.
10917533|NCT00646451|FG001|Participant Flow|Placebo First, Then Pregabalin|Placebo capsules: up to 4 capsules bid as tolerated. Study crossover design. Patients were randomized for treatment with PGB or placebo, titrated over 6 weeks.
10917534|NCT00646451|OG000|Outcome|1-Pregabalin|pregabalin : 75 mg bid to 300 mg bid based on per subject tolerability. Crossover study design and measure change in TRS Pregabalin group versus placebo group.
10917535|NCT00646451|OG001|Outcome|2-Placebo|placebo capsules : up to 4 capsules bid as tolerated. Crossover study design and measure change in TRS Pregabalin group versus placebo group.
10917536|NCT00646451|OG000|Outcome|Pregabalin|"Patients received the study drug at an initial dose of 75 mg twice daily, with upward titration to a target dose of 150 mg twice daily. Patients were given the option to increase the study drug to as high as 300 mg twice daily if inadequate benefit was perceived after 3 weeks of treatment. The study drug was increased at a rate of 150 mg/day/week. All patients in both periods were contacted by phone after two weeks of treatment to facilitate drug titration and address any adverse events. Patients were permitted to return to a lower dose if side effects occurred during drug titration.~After assessment protocols were completed, patients were titrated off the study drug at a rate of 150 mg every 2 days until discontinuation."
10917537|NCT00646451|OG001|Outcome|Placebo|"Patients received the study drug/matching placebo at an initial dose of 75 mg twice daily, with upward titration to a target dose of 150 mg twice daily. Patients were given the option to increase the study drug to as high as 300 mg twice daily if inadequate benefit was perceived after 3 weeks of treatment. The study drug was increased at a rate of 150 mg/day/week. All patients in both periods were contacted by phone after two weeks of treatment to facilitate drug titration and address any adverse events. Patients were permitted to return to a lower dose if side effects occurred during drug titration.~After assessment protocols were completed, patients were titrated off the study drug at a rate of 150 mg every 2 days until discontinuation."
10917538|NCT00646451|EG000|Reported Event|Pregabalin|pregabalin: 75 mg bid to 300 mg bid based on per subject tolerability
10917539|NCT00646451|EG001|Reported Event|Placebo|placebo capsules: up to 4 capsules bid as tolerated
10917540|NCT00646581|BG000|Baseline|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
10917541|NCT00646581|BG001|Baseline|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
10917542|NCT00646581|BG002|Baseline|Total|Total of all reporting groups
10917543|NCT00646581|FG000|Participant Flow|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
10917544|NCT00646581|FG001|Participant Flow|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
10917545|NCT00646581|OG000|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
10917546|NCT00646581|OG001|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
10917547|NCT00646581|EG000|Reported Event|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
10917548|NCT00646581|EG001|Reported Event|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
10917549|NCT00646646|BG000|Baseline|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
10917550|NCT00646646|BG001|Baseline|Midazolam|"Sedative~Midazolam : sedative"
10917551|NCT00646646|BG002|Baseline|Placebo|"placebo control~saline placebo : saline placebo"
10917552|NCT00646646|BG003|Baseline|Propofol|"active drug~propofol : sedative"
10917553|NCT00646646|BG004|Baseline|Total|Total of all reporting groups
10917554|NCT00646646|FG000|Participant Flow|Dexmedetomidine|Sedative Drug 1
10917555|NCT00646646|FG001|Participant Flow|Midazolam|Sedative Drug 2
10917556|NCT00646646|FG002|Participant Flow|Placebo|Placebo Control
10917557|NCT00646646|FG003|Participant Flow|Propofol|Sedative Drug 3
10917558|NCT00646646|OG000|Outcome|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
10917559|NCT00646646|OG001|Outcome|Midazolam|"Sedative~Midazolam : sedative"
10917560|NCT00646646|OG002|Outcome|Propofol|"active drug~propofol : sedative"
10917561|NCT00646646|OG003|Outcome|Placebo|placebo
10917562|NCT00646646|EG000|Reported Event|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
10917563|NCT00646646|EG001|Reported Event|Midazolam|"Sedative~Midazolam : sedative"
10917564|NCT00646646|EG002|Reported Event|Placebo|"placebo control~saline placebo : saline placebo"
10917565|NCT00646646|EG003|Reported Event|Propofol|"active drug~propofol : sedative"
10917566|NCT00646763|BG000|Baseline|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
10917567|NCT00646763|BG001|Baseline|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
10917568|NCT00646763|BG002|Baseline|Total|Total of all reporting groups
10917569|NCT00646763|FG000|Participant Flow|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
10917570|NCT00646763|FG001|Participant Flow|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
10917571|NCT00646763|OG000|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
10917572|NCT00646763|OG001|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
10917573|NCT00646763|EG000|Reported Event|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
10917574|NCT00646763|EG001|Reported Event|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
10917575|NCT00646776|BG000|Baseline|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
10917576|NCT00646776|BG001|Baseline|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
10917577|NCT00646776|BG002|Baseline|Total|Total of all reporting groups
10917578|NCT00646776|FG000|Participant Flow|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
10917579|NCT00646776|FG001|Participant Flow|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
10917580|NCT00646776|OG000|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
10917581|NCT00646776|OG001|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
10917582|NCT00646776|OG000|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
11174704|NCT02024204|FG000|Participant Flow|Visit 1 Uncontrolled LRS|"Patients who have uncontrolled LRS (ACT < 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.~Fluticasone propionate 230mcg for 3 Months~Salmeterol 21mcg for 3 Months"
10917583|NCT00646776|OG001|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QAD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
10917584|NCT00646776|OG002|Outcome|RIB 300 mg QD|AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD.
10917585|NCT00646776|EG000|Reported Event|ATV/RTV 300/100mg+RIB 150mg|
10917586|NCT00646776|EG001|Reported Event|RIB 150mg|
10917587|NCT00646906|BG000|Baseline|Phase 1a: Acetaminophen 1000mg / Aspirin|"All subjects in this arm (smokers (n=8) and non-smokers (n=8) will receive 81 mg aspirin at approximately 8 am followed by 1000 mg acetaminophen at approximately 10 am during one treatment phase (see Aspirin first intervention). During the other treatment phase, beginning after a 2 week washout, the order will be reversed and the subjects will receive 1000 mg acetaminophen at 8 am followed by 81 mg aspirin at 10 am (see Aspirin last intervention). The occurrence of the two study phases (interventions) will be randomized by order. Smokers and non-smokers will be matched for age and gender.~Aspirin first: Subjects will receive 81 mg aspirin at approximately 8 am followed by 1000 or 2000 mg acetaminophen at approximately 10 am during this intervention phase.~Aspirin last: Subjects will receive 1000 or 2000 mg acetaminophen at approximately 8am followed by 81 mg aspirin at approximately 10 am during this intervention phase."
10963149|NCT00870545|FG000|Participant Flow|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
11174705|NCT02024204|FG001|Participant Flow|Visit 1 Controlled LRS|"Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.~Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications."
10917588|NCT00646906|BG001|Baseline|Phase 1a: Acetaminophen 2000mg / Aspirin|"All subjects in this arm (smokers (n=8) and non-smoking volunteers (n=8)) will receive 81 mg aspirin at approximately 8 am followed by 2000 mg acetaminophen at approximately 10 am during one treatment phase (see Aspirin first intervention). During the other treatment phase, beginning after a 2 week washout, the order will be reversed and the subjects will receive 2000 mg acetaminophen at 8 am followed by 81 mg aspirin at 10 am (see Aspirin last intervention). The occurrence of the two study phases (interventions) will be randomized by order. Smokers and non-smokers will be matched for age and gender.~Aspirin first: Subjects will receive 81 mg aspirin at approximately 8 am followed by 1000 or 2000 mg acetaminophen at approximately 10 am during this intervention phase.~Aspirin last: Subjects will receive 1000 or 2000 mg acetaminophen at approximately 8am followed by 81 mg aspirin at approximately 10 am during this intervention phase."
10917589|NCT00646906|BG002|Baseline|Phase 1b: Acetaminophen 1000 mg Alone|"Eight male and non-pregnant female subjects who are healthy and non-smoking will be recruited. They will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM (see Acetaminophen 1000 mg/d intervention). Study assessments will be performed on day 1 and on day 6.~Acetaminophen 1000 mg/d: They will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM."
10917590|NCT00646906|BG003|Baseline|Phase 2: Acetaminophen vs. Ibuprofen|"Eight male and non-pregnant female subjects who are healthy and non-smoking will be recruited. In one treatment period of this cross-over study acetaminophen (1000 mg p.o.) will be administered orally at 8 AM, 2 PM, 8 PM and 2 AM for 3 days (see Acetaminophen 4000 mg/d intervention). The last dose will be administered on day four at 8 AM In the other treatment period, after a washout period of at least 14 days, the subjects will receive ibuprofen (200 mg) orally at at 8 AM, 2 PM, 8 PM and 2 AM for 3 days (see Ibuprofen 800 mg/d intervention). The last dose will be administered on day four at 8 AM.~Acetaminophen 4000 mg/d: Acetaminophen (1000 mg p.o.) orally at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. The last dose will be administered on day four at 8 AM.~Ibuprofen 800 mg/d: Ibuprofen (200 mg) orally at at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. The last dose will be administered on day four at 8 AM."
10917591|NCT00646906|BG004|Baseline|Total|Total of all reporting groups
10917592|NCT00646906|FG000|Participant Flow|Phase 1a: Aspirin 81 mg / Acetaminophen 1000 mg Sequence 1|"All subjects in this arm of the study termed Phase 1a (smokers (n=8) and non-smokers (n=8) will receive 81 mg aspirin at 8 am followed by 1000 mg acetaminophen at 10 am each day, for six days during the first crossover period (Aspirin first). During the second crossover period, beginning after a 2 week washout, the order will be reversed and the subjects will receive 1000 mg acetaminophen at 8 am followed by 81 mg aspirin at 10 am each day, for six days (Aspirin last). The occurrence of the two crossover periods (interventions) will be randomized by order. Smokers and non-smokers will be matched for age and gender."
10917593|NCT00646906|FG001|Participant Flow|Phase 1a: Aspirin 81 mg / Acetaminophen 1000 mg Sequence 2|"All subjects in this arm of the study termed Phase 1a (smokers (n=8) and non-smokers (n=8) will receive 1000 mg acetaminophen at 8 am followed by 81 mg aspirin at 10 am each day, for six days during the first crossover period (Aspirin last). During the second crossover period, beginning after a 2 week washout, the order will be reversed and the subjects will receive 81 mg aspirin at 8 am followed by 1000 mg acetaminophen at 10 am each day, for six days (Aspirin first). The occurrence of the two crossover periods (interventions) will be randomized by order. Smokers and non-smokers will be matched for age and gender."
10917594|NCT00646906|FG002|Participant Flow|Phase 1a: Aspirin 81 mg / Acetaminophen 2000 mg Sequence 1|"All subjects in this arm of the study termed Phase 1a (smokers (n=8) and non-smokers (n=8) will receive 81 mg aspirin at 8 am followed by 2000 mg acetaminophen at 10 am each day, for six days during the first crossover period (Aspirin first). During the second crossover period, beginning after a 2 week washout, the order will be reversed and the subjects will receive 2000 mg acetaminophen at 8 am followed by 81 mg aspirin at 10 am each day, for six days (Aspirin last). The occurrence of the two crossover periods (interventions) will be randomized by order. Smokers and non-smokers will be matched for age and gender."
10917595|NCT00646906|FG003|Participant Flow|Phase 1a: Aspirin 81 mg / Acetaminophen 2000 mg Sequence 2|"All subjects in this arm of the study termed Phase 1a (smokers (n=8) and non-smokers (n=8) will receive 2000 mg acetaminophen at 8 am followed by 81 mg aspirin at 10 am each day, for six days during the first crossover period (Aspirin last). During the second crossover period, beginning after a 2 week washout, the order will be reversed and the subjects will receive 81 mg aspirin at 8 am followed by 2000 mg acetaminophen at 10 am each day, for six days (Aspirin first). The occurrence of the two crossover periods (interventions) will be randomized by order. Smokers and non-smokers will be matched for age and gender."
10917596|NCT00646906|FG004|Participant Flow|Phase 1b: Acetaminophen 1000mg Alone: 4 Days|"Eight healthy, non-smoking subjects will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM. Study assessments will be performed on day 1 and on day 6.~Phase 1b is not a crossover design. Phase 1b will end after the first treatment period, which will be identical for all subjects."
10917597|NCT00646906|FG005|Participant Flow|Phase 2: Acetaminophen 4000 mg/d / Ibuprofen 800 mg/d|"In the first period of this arm of the crossover study termed Phase 2, healthy non-smoking subjects will be administered acetaminophen (1000 mg) orally at 8 AM, 2 PM, 8 PM and 2 AM (4000 mg/d) for 3 days. The last dose will be administered on day four at 8 AM In the other crossover period, after a washout period of at least 14 days, the subjects will receive ibuprofen (200 mg) orally at 8 AM, 2 PM, 8 PM and 2 AM (800 mg/d) for 3 days. The last dose will be administered on day four at 8 AM. The treatment periods will be randomized by order."
10917598|NCT00646906|FG006|Participant Flow|Phase 2: Ibuprofen 800 mg/d / Acetaminophen 4000 mg/d|"In the first period of this arm of the crossover study termed Phase 2, healthy non-smoking subjects will be administered ibuprofen (200 mg) orally at 8 AM, 2 PM, 8 PM and 2 AM (800 mg/d) for 3 days. The last dose will be administered on day four at 8 AM In the other crossover period, after a washout period of at least 14 days, the subjects will receive acetaminophen (1000 mg) orally at 8 AM, 2 PM, 8 PM and 2 AM (4000 mg/d) for 3 days. The last dose will be administered on day four at 8 AM. The treatment periods will be randomized by order."
10917599|NCT00646906|OG000|Outcome|Phase 1a: Acetaminophen 1000 mg / Aspirin First|81 mg aspirin at 8 am followed by 1000 mg acetaminophen at 10 am.
10917600|NCT00646906|OG001|Outcome|Phase 1a: Acetaminophen 1000 mg / Aspirin Last|1000 mg acetaminophen at 8am followed by 81 mg aspirin at 10 am.
10917601|NCT00646906|OG002|Outcome|Phase 1a: Acetaminophen 2000 mg / Aspirin First|81 mg aspirin at 8 am followed by 2000 mg acetaminophen at 10 am.
10917602|NCT00646906|OG003|Outcome|Phase 1a: Acetaminophen 2000 mg / Aspirin Last|2000 mg acetaminophen at 8am followed by 81 mg aspirin at 10 am.
10917603|NCT00646906|OG004|Outcome|Phase 1b: Acetaminophen 1000 mg/d|"Eight male and non-pregnant female subjects who are healthy and non-smoking will be recruited. They will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM (see Acetaminophen 1000 mg/d intervention). Study assessments will be performed on day 1 and on day 6.~Acetaminophen 1000 mg/d: They will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM."
10917604|NCT00646906|OG005|Outcome|Phase 2: Acetaminophen 4000 mg/d|Acetaminophen (1000 mg p.o.) orally at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. Last dose on day four at 8 AM.
10917605|NCT00646906|OG006|Outcome|Phase 2: Ibuprofen 800 mg/d|Ibuprofen (200 mg) orally at at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. Last dose on day four at 8 AM.
10917606|NCT00646906|EG000|Reported Event|Phase 1a: Acetaminophen 1000mg / Aspirin|"All subjects in this arm (smokers (n=8) and non-smokers (n=8) will receive 81 mg aspirin at approximately 8 am followed by 1000 mg acetaminophen at approximately 10 am during one treatment phase (see Aspirin first intervention). During the other treatment phase, beginning after a 2 week washout, the order will be reversed and the subjects will receive 1000 mg acetaminophen at 8 am followed by 81 mg aspirin at 10 am (see Aspirin last intervention). The occurrence of the two study phases (interventions) will be randomized by order. Smokers and non-smokers will be matched for age and gender.~Aspirin first: Subjects will receive 81 mg aspirin at approximately 8 am followed by 1000 or 2000 mg acetaminophen at approximately 10 am during this intervention phase.~Aspirin last: Subjects will receive 1000 or 2000 mg acetaminophen at approximately 8am followed by 81 mg aspirin at approximately 10 am during this intervention phase."
10917607|NCT00646906|EG001|Reported Event|Phase 1a: Acetaminophen 2000mg / Aspirin|"All subjects in this arm (smokers (n=8) and non-smoking volunteers (n=8)) will receive 81 mg aspirin at approximately 8 am followed by 2000 mg acetaminophen at approximately 10 am during one treatment phase (see Aspirin first intervention). During the other treatment phase, beginning after a 2 week washout, the order will be reversed and the subjects will receive 2000 mg acetaminophen at 8 am followed by 81 mg aspirin at 10 am (see Aspirin last intervention). The occurrence of the two study phases (interventions) will be randomized by order. Smokers and non-smokers will be matched for age and gender.~Aspirin first: Subjects will receive 81 mg aspirin at approximately 8 am followed by 1000 or 2000 mg acetaminophen at approximately 10 am during this intervention phase.~Aspirin last: Subjects will receive 1000 or 2000 mg acetaminophen at approximately 8am followed by 81 mg aspirin at approximately 10 am during this intervention phase."
10917608|NCT00646906|EG002|Reported Event|Phase 1b: Acetaminophen 1000 mg Alone|"Eight male and non-pregnant female subjects who are healthy and non-smoking will be recruited. They will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM (see Acetaminophen 1000 mg/d intervention). Study assessments will be performed on day 1 and on day 6.~Acetaminophen 1000 mg/d: They will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM."
10917609|NCT00646906|EG003|Reported Event|Phase 2: Acetaminophen vs. Ibuprofen|"Eight male and non-pregnant female subjects who are healthy and non-smoking will be recruited. In one treatment period of this cross-over study acetaminophen (1000 mg p.o.) will be administered orally at 8 AM, 2 PM, 8 PM and 2 AM for 3 days (see Acetaminophen 4000 mg/d intervention). The last dose will be administered on day four at 8 AM In the other treatment period, after a washout period of at least 14 days, the subjects will receive ibuprofen (200 mg) orally at at 8 AM, 2 PM, 8 PM and 2 AM for 3 days (see Ibuprofen 800 mg/d intervention). The last dose will be administered on day four at 8 AM.~Acetaminophen 4000 mg/d: Acetaminophen (1000 mg p.o.) orally at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. The last dose will be administered on day four at 8 AM.~Ibuprofen 800 mg/d: Ibuprofen (200 mg) orally at at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. The last dose will be administered on day four at 8 AM."
10917610|NCT00646958|BG000|Baseline|Radezolid QD|450 mg by mouth (PO) once daily (QD)
11234033|NCT02431806|OG000|Outcome|Placebo|Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
11357567|NCT03755882|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
10917611|NCT00646958|BG001|Baseline|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
10917612|NCT00646958|BG002|Baseline|Linezolid BID|600 mg by mouth (PO) BID
10917613|NCT00646958|BG003|Baseline|Total|Total of all reporting groups
10917614|NCT00646958|FG000|Participant Flow|Radezolid QD|450 mg by mouth (PO) once daily (QD)
10917615|NCT00646958|FG001|Participant Flow|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
10917616|NCT00646958|FG002|Participant Flow|Linezolid BID|600 mg by mouth (PO) BID
10917617|NCT00646958|OG000|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
10917618|NCT00646958|OG001|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
10917619|NCT00646958|OG002|Outcome|Linezolid BID|600 mg by mouth (PO) BID
10917620|NCT00646958|EG000|Reported Event|Radezolid QD|450 mg by mouth (PO) once daily (QD)
10917621|NCT00646958|EG001|Reported Event|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
10917622|NCT00646958|EG002|Reported Event|Linezolid BID|600 mg by mouth (PO) BID
10917623|NCT00647270|BG000|Baseline|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
10917624|NCT00647270|BG001|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
10917625|NCT00647270|BG002|Baseline|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
10917626|NCT00647270|BG003|Baseline|Total|Total of all reporting groups
10917627|NCT00647270|FG000|Participant Flow|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
10917628|NCT00647270|FG001|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
10917629|NCT00647270|FG002|Participant Flow|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
10917630|NCT00647270|OG000|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
10917631|NCT00647270|OG001|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
10917632|NCT00647270|OG002|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
10917633|NCT00647270|EG000|Reported Event|Placebo Every Other Week (Eow)-Period 1|Placebo eow for 12 weeks for Period 1 Adalimumab 40 mg eow for remaining 12 weeks for Period 2
10917634|NCT00647270|EG001|Reported Event|Adalimumab 40 mg Eow -Period 1|Adalimumab 40 mg eow for Period 1 and Period 2
10917635|NCT00647270|EG002|Reported Event|Adalimumab 80 mg Monthly-Period 1|Adalimumab 80 mg monthly for Period 1 and Period 2
10917636|NCT00647270|EG003|Reported Event|Placebo/Adalimumab 40 mg Eow-Period 2|Placebo 40 mg eow for Period 1 (weeks 1-12) Subjects switched to Adalimumab 40 mg eow for remaining 12 weeks for Period 2
10917637|NCT00647270|EG004|Reported Event|Adalimumab 40 mg Eow-Period 2|Adalimumab 40 mg eow for Period 1 and Period 2
10917638|NCT00647270|EG005|Reported Event|Adalimumab 80 mg Monthly - Period 2|Adalimumab 80 mg monthly for Period 1 and Period 2
10917639|NCT00647296|BG000|Baseline|Placebo|PBO BID for 12 weeks
10917640|NCT00647296|BG001|Baseline|50 mg/Day|25 mg BID for 12 weeks
10917641|NCT00647296|BG002|Baseline|150 mg/Day|75 mg BID for 12 weeks
10917642|NCT00647296|BG003|Baseline|300 mg/Day|150 mg BID for 12 weeks
10917643|NCT00647296|BG004|Baseline|Total|Total of all reporting groups
10917644|NCT00647296|FG000|Participant Flow|Placebo Twice Daily|Placebo (PBO) BID (twice daily)
10917645|NCT00647296|FG001|Participant Flow|50 mg/Day Dexpramipexole|dexpramipexole 25 mg BID (twice daily)
10917646|NCT00647296|FG002|Participant Flow|150 mg/Day Dexpramipexole|dexpramipexole 75 mg BID (twice daily)
10917647|NCT00647296|FG003|Participant Flow|300 mg/Day Dexpramipexole|dexpramipexole 150 mg BID (twice daily)
10917648|NCT00647296|OG000|Outcome|Placebo|PBO BID for 12 weeks
10917649|NCT00647296|OG001|Outcome|50 mg/Day|25 mg dexpramipexole BID for 12 weeks
10917650|NCT00647296|OG002|Outcome|150 mg/Day|75 mg dexpramipexole BID for 12 weeks
10917651|NCT00647296|OG003|Outcome|300 mg/Day|150 mg dexpramipexole BID for 12 weeks
10917652|NCT00647296|OG000|Outcome|Placebo|Two matching PBO tablets taken orally twice daily for 12 weeks
10917653|NCT00647296|OG001|Outcome|Dexpramipexole (50 mg/Day)|Two 12.5 mg tablets taken orally twice daily for 12 weeks
10917654|NCT00647296|OG002|Outcome|Dexpramipexole (150 mg/Day)|Two 37.5 mg tablets taken orally twice daily for 12 weeks
10917655|NCT00647296|OG003|Outcome|Dexpramipexole (300 mg/Day)|Two 75 mg tablets taken orally twice daily for 12 weeks
10917656|NCT00647296|OG000|Outcome|Placebo|Part 2: 4-week placebo washout
10917657|NCT00647296|OG000|Outcome|50 mg/Day|25 mg BID for 12 weeks
10917658|NCT00647296|OG001|Outcome|300 mg/Day|150 mg BID for 12 weeks
10917659|NCT00647296|OG000|Outcome|Dexpramipexole (50 mg/Day)|Two 12.5 mg tablets taken orally twice daily for 12 weeks
10917660|NCT00647296|OG001|Outcome|Dexpramipexole (300 mg/Day)|Two 75 mg tablets taken orally twice daily for 12 weeks
10917661|NCT00647296|EG000|Reported Event|Part 1: Placebo|Two matching PBO tablets taken orally twice daily for 12 weeks
10917662|NCT00647296|EG001|Reported Event|Part 1: Dexpramipexole (50 mg/Day)|Two 12.5 mg tablets taken orally twice daily for 12 weeks
10917663|NCT00647296|EG002|Reported Event|Part 1: Dexpramipexole (150 mg/Day)|Two 37.5 mg tablets taken orally twice daily for 12 weeks
10917664|NCT00647296|EG003|Reported Event|Part 1: Dexpramipexole (300 mg/Day)|Two 75 mg tablets taken orally twice daily for 12 weeks
10917665|NCT00647296|EG004|Reported Event|Part 2: Placebo Washout|Two matching PBO tablets taken orally twice daily for 4 weeks
10917666|NCT00647296|EG005|Reported Event|Part 2: Dexpramipexole (50 mg/Day)|Two 12.5 mg tablets taken orally twice daily for up to 18 months
10917667|NCT00647296|EG006|Reported Event|Part 2: Dexpramipexole (300 mg/Day)|Two 75 mg tablets taken orally twice daily for up to 18 months
10917668|NCT00647348|BG000|Baseline|Simvastatin 80mg OD|Simvastatin: 80mg simvastatin oral once daily for 24 months
10917669|NCT00647348|BG001|Baseline|Placebo|Placebo: Oral placebo tablet once daily for 24 months
10917670|NCT00647348|BG002|Baseline|Total|Total of all reporting groups
10917671|NCT00647348|FG000|Participant Flow|Simvastatin 80mg OD|Simvastatin: 80mg simvastatin oral once daily for 24 months
10917672|NCT00647348|FG001|Participant Flow|Placebo|Placebo: Oral placebo tablet once daily for 24 months
10917673|NCT00647348|OG000|Outcome|Simvastatin 80mg OD|Simvastatin: 80mg simvastatin oral once daily for 24 months
10917674|NCT00647348|OG001|Outcome|Placebo|Placebo: Oral placebo tablet once daily for 24 months
10917675|NCT00647348|EG000|Reported Event|Simvastatin 80mg OD|Simvastatin: 80mg simvastatin oral once daily for 24 months
10917676|NCT00647348|EG001|Reported Event|Placebo|Placebo: Oral placebo tablet once daily for 24 months
10917677|NCT00647400|BG000|Baseline|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
10917678|NCT00647400|BG001|Baseline|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
10917679|NCT00647400|BG002|Baseline|Total|Total of all reporting groups
10917680|NCT00647400|FG000|Participant Flow|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
11357568|NCT03755882|OG000|Outcome|Test (Etafilcon A)|Subjects that wore the Test lens in either the first or second period of the study.
10917681|NCT00647400|FG001|Participant Flow|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
10917682|NCT00647400|OG000|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
10917683|NCT00647400|OG001|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
10917684|NCT00647400|EG000|Reported Event|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
10917685|NCT00647400|EG001|Reported Event|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
10917686|NCT00647556|BG000|Baseline|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
10917687|NCT00647556|BG001|Baseline|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
10917688|NCT00647556|BG002|Baseline|Total|Total of all reporting groups
10917689|NCT00647556|FG000|Participant Flow|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
10917690|NCT00647556|FG001|Participant Flow|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
10917691|NCT00647556|OG000|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
10917692|NCT00647556|OG001|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
10917693|NCT00647556|EG000|Reported Event|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
10917694|NCT00647556|EG001|Reported Event|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
10917695|NCT00647699|BG000|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
10917696|NCT00647699|BG001|Baseline|Control Group|riboflavin ophthalmic solution without UVA irradiation
10917697|NCT00647699|BG002|Baseline|Total|Total of all reporting groups
10917698|NCT00647699|FG000|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
11357569|NCT03755882|OG001|Outcome|Control (Hefilcon A)|Subjects that wore the Control lens in either the first or second period of the study.
10917699|NCT00647699|FG001|Participant Flow|Control Group|riboflavin ophthalmic solution without UVA irradiation
10917700|NCT00647699|OG000|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
10917701|NCT00647699|OG001|Outcome|Control Group|riboflavin ophthalmic solution without UVA irradiation
10917702|NCT00647699|EG000|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
10917703|NCT00647699|EG001|Reported Event|Control Group|riboflavin ophthalmic solution without UVA irradiation
10917704|NCT00647998|BG000|Baseline|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
10917705|NCT00647998|BG001|Baseline|Standard Care|No darbepoetin
10917706|NCT00647998|BG002|Baseline|Total|Total of all reporting groups
10917707|NCT00647998|FG000|Participant Flow|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
10917708|NCT00647998|FG001|Participant Flow|Standard Care|No darbepoetin
10917709|NCT00647998|OG000|Outcome|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
10917710|NCT00647998|OG001|Outcome|Standard Care|No darbepoetin
10917711|NCT00647998|OG000|Outcome|Darbepoetin|"Patients received 1mg/kg IV Darbepoetin immediately prior to surgery~Darbepoetin alfa: Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery~Standard care"
10917712|NCT00647998|OG001|Outcome|Standard Care|"No Darbepoetin~Standard care"
10917713|NCT00647998|EG000|Reported Event|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
10917714|NCT00647998|EG001|Reported Event|Standard Care|No darbepoetin
10917715|NCT00648037|BG000|Baseline|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
10917716|NCT00648037|FG000|Participant Flow|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
10917717|NCT00648037|OG000|Outcome|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
10917718|NCT00648037|EG000|Reported Event|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
10917719|NCT00648115|BG000|Baseline|Basic Vocational Services|Basic vocational services but no manualized vocational program
11357570|NCT03755882|EG000|Reported Event|Test (Etafilcon A)|Subjects that wore the Test lens in either the first or second period of the study.
11357571|NCT03755882|EG001|Reported Event|Control (Hefilcon A)|Subjects that wore the Control lens in either the first or second period of the study.
10917720|NCT00648115|BG001|Baseline|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
10917721|NCT00648115|BG002|Baseline|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
10917722|NCT00648115|BG003|Baseline|Total|Total of all reporting groups
10917723|NCT00648115|FG000|Participant Flow|Basic Vocational Services|Basic vocational services but no manualized vocational program
10917724|NCT00648115|FG001|Participant Flow|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
10917725|NCT00648115|FG002|Participant Flow|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
10917726|NCT00648115|OG000|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
10917727|NCT00648115|OG001|Outcome|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
10917728|NCT00648115|OG002|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
10917729|NCT00648115|EG000|Reported Event|Arm 1|Basic vocational services but no manualized vocational program
10917730|NCT00648115|EG001|Reported Event|Arm 2|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
10917731|NCT00648115|EG002|Reported Event|Arm 3|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
10917732|NCT00648167|BG000|Baseline|KRX-0502|Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)
10917733|NCT00648167|FG000|Participant Flow|KRX-0502|Ferric Citrate
10917734|NCT00648167|OG000|Outcome|KRX-0502 (Ferric Citrate)|Patients starting dose of 4.5 grams per day (n=34) and those starting on 6.0 grams per day (n=21)- immediate roll over from previous phosphate binder(s)
11234034|NCT02431806|OG001|Outcome|Levomilnacipran 40 mg/Day|Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
10917735|NCT00648167|EG000|Reported Event|KRX-0502|"Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)~Intent-to-Treat (ITT)"
10917736|NCT00648375|BG000|Baseline|Propranolol|"Participants will take propranolol for 14 weeks.~Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.~Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day."
10964034|NCT00875550|OG001|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
10917737|NCT00648375|BG001|Baseline|Placebo|"Participants will take placebo for 14 weeks.~Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.~Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day."
10917738|NCT00648375|BG002|Baseline|Total|Total of all reporting groups
10917739|NCT00648375|FG000|Participant Flow|Propranolol|"Participants will take propranolol for 14 weeks.~Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.~Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day."
10917740|NCT00648375|FG001|Participant Flow|Placebo|"Participants will take placebo for 14 weeks.~Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.~Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day."
10917741|NCT00648375|OG000|Outcome|Propranolol|"Participants will take propranolol for 14 weeks.~Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.~Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day."
10917742|NCT00648375|OG001|Outcome|Placebo|"Participants will take placebo for 14 weeks.~Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.~Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day."
10917743|NCT00648375|EG000|Reported Event|Propranolol|"Participants will take propranolol for 14 weeks.~Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.~Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day."
10917744|NCT00648375|EG001|Reported Event|Placebo|"Participants will take placebo for 14 weeks.~Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.~Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day."
10917745|NCT00648648|BG000|Baseline|MK-1775 325 mg Single Dose|Participants received MK-1775 325 mg, orally, on Day 1.
10917746|NCT00648648|BG001|Baseline|MK-1775 650 mg Single Dose|Participants received MK-1775 650 mg, orally, on Day 1.
10917747|NCT00648648|BG002|Baseline|MK-1775 1300 mg Single Dose|Participants received MK-1775 1300 mg, orally, on Day 1.
10917748|NCT00648648|BG003|Baseline|MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2|Participants received gemcitabine 1000 mg/m^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
10917749|NCT00648648|BG004|Baseline|MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
10917750|NCT00648648|BG005|Baseline|MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
11174706|NCT02024204|OG000|Outcome|Visit 1 Uncontrolled LRS|"Patients who have uncontrolled LRS (ACT < 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.~Fluticasone propionate 230mcg for 3 Months~Salmeterol 21mcg for 3 Months"
11357572|NCT03755661|BG000|Baseline|Intervention|"This intervention arm is a combined in-person text messaging intervention~MI&TXT4MSM: brief in-person intervention followed by text messaging"
10917751|NCT00648648|BG006|Baseline|MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
10917752|NCT00648648|BG007|Baseline|MK-1775 100 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
10917753|NCT00648648|BG008|Baseline|MK-1775 200 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
10917754|NCT00648648|BG009|Baseline|MK-1775 325 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
10917755|NCT00648648|BG010|Baseline|MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
10964035|NCT00875550|OG000|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
11174707|NCT02024204|OG001|Outcome|Visit 1 Controlled LRS|"Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.~Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications."
11174708|NCT02024204|EG000|Reported Event|Uncontrolled LRS|"Patients who have uncontrolled lower respiratory symptoms (ACT < 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.~Fluticasone propionate 230mcg for 3 Months~Salmeterol 21mcg for 3 Months"
11174709|NCT02024204|EG001|Reported Event|Controlled LRS|"Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.~Current Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications."
11174710|NCT02024386|BG000|Baseline|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
11174711|NCT02024386|BG001|Baseline|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
11174712|NCT02024386|BG002|Baseline|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
11174713|NCT02024386|BG003|Baseline|Total|Total of all reporting groups
11174714|NCT02024386|FG000|Participant Flow|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
11174715|NCT02024386|FG001|Participant Flow|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
11174716|NCT02024386|FG002|Participant Flow|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
11174717|NCT02024386|OG000|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
11174718|NCT02024386|OG001|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
11174719|NCT02024386|OG002|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
11174720|NCT02024386|OG000|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
11174721|NCT02024386|EG000|Reported Event|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period. A second VO2 max test will be repeated at altitude."
11174722|NCT02024386|EG001|Reported Event|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period. A second VO2 max test will be repeated at altitude."
11174723|NCT02024386|EG002|Reported Event|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
11174724|NCT02024477|BG000|Baseline|Placebo|Placebo: 1 tablet daily for 12 weeks
11174725|NCT02024477|BG001|Baseline|Saxagliptin|Saxagliptin: 5 mg tablet once daily for 12 weeks
11174726|NCT02024477|BG002|Baseline|Total|Total of all reporting groups
11174727|NCT02024477|FG000|Participant Flow|Placebo|Placebo: 1 tablet daily for 12 weeks
11174728|NCT02024477|FG001|Participant Flow|Saxagliptin|Saxagliptin: 5 mg tablet once daily for 12 weeks
11174729|NCT02024477|OG000|Outcome|Placebo|Placebo: 1 tablet daily for 12 weeks
11174730|NCT02024477|OG001|Outcome|Saxagliptin|Saxagliptin: 5 mg tablet once daily for 12 weeks
11174731|NCT02024477|EG000|Reported Event|Placebo|Placebo: 1 tablet daily for 12 weeks
11174732|NCT02024477|EG001|Reported Event|Saxagliptin|Saxagliptin 5mg once daily for 12 weeks
11357573|NCT03755661|BG001|Baseline|Assessment Only Control|The is the assessment only comparison condition
10917756|NCT00648648|BG011|Baseline|MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
10917757|NCT00648648|BG012|Baseline|MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
10917758|NCT00648648|BG013|Baseline|MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917759|NCT00648648|BG014|Baseline|MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917760|NCT00648648|BG015|Baseline|MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917761|NCT00648648|BG016|Baseline|MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917762|NCT00648648|BG017|Baseline|MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917763|NCT00648648|BG018|Baseline|MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917764|NCT00648648|BG019|Baseline|MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917765|NCT00648648|BG020|Baseline|MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917766|NCT00648648|BG021|Baseline|MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917767|NCT00648648|BG022|Baseline|MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917768|NCT00648648|BG023|Baseline|MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917769|NCT00648648|BG024|Baseline|MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917770|NCT00648648|BG025|Baseline|MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917771|NCT00648648|BG026|Baseline|MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917772|NCT00648648|BG027|Baseline|MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
11174733|NCT02024646|BG000|Baseline|210 mg Brodalumab|"Administered via subcutaneous injections.~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection."
11174734|NCT02024646|BG001|Baseline|140 mg Brodalumab|"Administered via subcutaneous injection.~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection."
10917773|NCT00648648|BG028|Baseline|Total|Total of all reporting groups
10917774|NCT00648648|FG000|Participant Flow|MK-1775 325 mg Single Dose|Participants received MK-1775 325 mg, orally, on Day 1.
10917775|NCT00648648|FG001|Participant Flow|MK-1775 650 mg Single Dose|Participants received MK-1775 650 mg, orally, on Day 1.
10917776|NCT00648648|FG002|Participant Flow|MK-1775 1300 mg Single Dose|Participants received MK-1775 1300 mg, orally, on Day 1.
11174735|NCT02024646|BG002|Baseline|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
11174736|NCT02024646|BG003|Baseline|Total|Total of all reporting groups
11174737|NCT02024646|FG000|Participant Flow|210 mg Brodalumab|"Administered via subcutaneous injections.~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection."
11357574|NCT03755661|BG002|Baseline|Total|Total of all reporting groups
10917777|NCT00648648|FG003|Participant Flow|MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2|Participants received gemcitabine 1000 mg/m^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
10917778|NCT00648648|FG004|Participant Flow|MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
10917779|NCT00648648|FG005|Participant Flow|MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
10917780|NCT00648648|FG006|Participant Flow|MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
10917781|NCT00648648|FG007|Participant Flow|MK-1775 100 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
11174738|NCT02024646|FG001|Participant Flow|140 mg Brodalumab|"Administered via subcutaneous injection.~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection."
10917782|NCT00648648|FG008|Participant Flow|MK-1775 200 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
10917783|NCT00648648|FG009|Participant Flow|MK-1775 325 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
10917784|NCT00648648|FG010|Participant Flow|MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
10917785|NCT00648648|FG011|Participant Flow|MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
10917786|NCT00648648|FG012|Participant Flow|MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
10917787|NCT00648648|FG013|Participant Flow|MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917788|NCT00648648|FG014|Participant Flow|MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917789|NCT00648648|FG015|Participant Flow|MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917790|NCT00648648|FG016|Participant Flow|MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917791|NCT00648648|FG017|Participant Flow|MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917792|NCT00648648|FG018|Participant Flow|MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917793|NCT00648648|FG019|Participant Flow|MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917794|NCT00648648|FG020|Participant Flow|MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917795|NCT00648648|FG021|Participant Flow|MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917796|NCT00648648|FG022|Participant Flow|MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917797|NCT00648648|FG023|Participant Flow|MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
11174739|NCT02024646|FG002|Participant Flow|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
10917798|NCT00648648|FG024|Participant Flow|MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917799|NCT00648648|FG025|Participant Flow|MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917800|NCT00648648|FG026|Participant Flow|MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917801|NCT00648648|FG027|Participant Flow|MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917802|NCT00648648|OG000|Outcome|MK-1775 325 mg Single Dose|Participants received MK-1775 325 mg, orally, on Day 1.
10917803|NCT00648648|OG001|Outcome|MK-1775 650 mg Single Dose|Participants received MK-1775 650 mg, orally, on Day 1.
10917804|NCT00648648|OG002|Outcome|MK-1775 1300 mg Single Dose|Participants received MK-1775 1300 mg, orally, on Day 1.
10917805|NCT00648648|OG003|Outcome|MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2|Participants received gemcitabine 1000 mg/m^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
10917806|NCT00648648|OG004|Outcome|MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
10917807|NCT00648648|OG005|Outcome|MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
10917808|NCT00648648|OG006|Outcome|MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
10917809|NCT00648648|OG007|Outcome|MK-1775 100 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
10917810|NCT00648648|OG008|Outcome|MK-1775 200 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
10917811|NCT00648648|OG009|Outcome|MK-1775 325 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
10917812|NCT00648648|OG010|Outcome|MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
10917813|NCT00648648|OG011|Outcome|MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
10917814|NCT00648648|OG012|Outcome|MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
10917815|NCT00648648|OG013|Outcome|MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917816|NCT00648648|OG014|Outcome|MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917817|NCT00648648|OG015|Outcome|MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917818|NCT00648648|OG016|Outcome|MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917819|NCT00648648|OG017|Outcome|MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917820|NCT00648648|OG018|Outcome|MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917821|NCT00648648|OG019|Outcome|MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917822|NCT00648648|OG020|Outcome|MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917823|NCT00648648|OG021|Outcome|MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917824|NCT00648648|OG022|Outcome|MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917825|NCT00648648|OG023|Outcome|MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917826|NCT00648648|OG024|Outcome|MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917827|NCT00648648|OG025|Outcome|MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917828|NCT00648648|OG026|Outcome|MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917829|NCT00648648|OG027|Outcome|MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917830|NCT00648648|EG000|Reported Event|MK-1775 325 mg Single Dose|Participants received MK-1775 325 mg, orally, on Day 1.
10917831|NCT00648648|EG001|Reported Event|MK-1775 650 mg Single Dose|Participants received MK-1775 650 mg, orally
10917832|NCT00648648|EG002|Reported Event|MK-1775 1300 mg Single Dose|Participants received MK-1775 1300 mg, orally, on Day 1.
10917833|NCT00648648|EG003|Reported Event|MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
11357575|NCT03755661|FG000|Participant Flow|Intervention|"This intervention arm is a combined in-person text messaging intervention~MI&TXT4MSM: brief in-person intervention followed by text messaging"
10917834|NCT00648648|EG004|Reported Event|MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
10917835|NCT00648648|EG005|Reported Event|MK-1775 100 mg Single Dose + Cisplatin 75 mg/m2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
10917836|NCT00648648|EG006|Reported Event|MK-1775 200 mg Single Dose + Cisplatin 75 mg/m2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
10917837|NCT00648648|EG007|Reported Event|MK-1775 100 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
10917838|NCT00648648|EG008|Reported Event|MK-1775 200 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
10917839|NCT00648648|EG009|Reported Event|MK-1775 325 mg Single Dose + Carboplatin AUC 5|Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
10917840|NCT00648648|EG010|Reported Event|MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
10917841|NCT00648648|EG011|Reported Event|MK-1775 50/25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
10917842|NCT00648648|EG012|Reported Event|MK-1775 50 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
11357576|NCT03755661|FG001|Participant Flow|Assessment Only Control|This condition includes only assessment measures. It is used as the comparison condition to the intervention under study.
11357577|NCT03755661|OG000|Outcome|Intervention|"This intervention arm is a combined in-person text messaging intervention~MI&TXT4MSM: brief in-person intervention followed by text messaging"
10917843|NCT00648648|EG013|Reported Event|MK-1775 100 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917844|NCT00648648|EG014|Reported Event|MK-1775 125 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917845|NCT00648648|EG015|Reported Event|MK-1775 150 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917846|NCT00648648|EG016|Reported Event|MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917847|NCT00648648|EG017|Reported Event|MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2|Participants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
10917848|NCT00648648|EG018|Reported Event|MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917849|NCT00648648|EG019|Reported Event|MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917850|NCT00648648|EG020|Reported Event|MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917851|NCT00648648|EG021|Reported Event|MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917852|NCT00648648|EG022|Reported Event|MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917853|NCT00648648|EG023|Reported Event|MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2|Participants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917854|NCT00648648|EG024|Reported Event|MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
11357578|NCT03755661|OG001|Outcome|Assessment Only Control|The is the assessment only comparison condition
10917855|NCT00648648|EG025|Reported Event|MK-1775 150 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917856|NCT00648648|EG026|Reported Event|MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917857|NCT00648648|EG027|Reported Event|MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5|Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
10917858|NCT00648739|BG000|Baseline|Samalizumab|All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917859|NCT00648739|FG000|Participant Flow|Samalizumab 50 mg/m^2|Participants assigned to this dose cohort received a single intravenous (IV) dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917860|NCT00648739|FG001|Participant Flow|Samalizumab 100 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917861|NCT00648739|FG002|Participant Flow|Samalizumab 200 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
11174740|NCT02024646|OG000|Outcome|210 mg Brodalumab|"Administered via subcutaneous injections.~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection."
11174741|NCT02024646|OG001|Outcome|140 mg Brodalumab|"Administered via subcutaneous injection.~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection."
10917862|NCT00648739|FG003|Participant Flow|Samalizumab 300 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917863|NCT00648739|FG004|Participant Flow|Samalizumab 400 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917864|NCT00648739|FG005|Participant Flow|Samalizumab 500 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917865|NCT00648739|FG006|Participant Flow|Samalizumab 600 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917866|NCT00648739|OG000|Outcome|Samalizumab|All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917867|NCT00648739|OG000|Outcome|Samalizumab 50 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917868|NCT00648739|OG001|Outcome|Samalizumab 100 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917869|NCT00648739|OG002|Outcome|Samalizumab 200 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917870|NCT00648739|OG003|Outcome|Samalizumab 300 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917871|NCT00648739|OG004|Outcome|Samalizumab 400 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917872|NCT00648739|OG005|Outcome|Samalizumab 500 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917873|NCT00648739|OG006|Outcome|Samalizumab 600 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917874|NCT00648739|OG007|Outcome|Overall|All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917875|NCT00648739|OG003|Outcome|Samalizumab 300 mg/m^2|Participants assigned to this dose cohort received a single IV 300 mg/m^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917876|NCT00648739|OG000|Outcome|Samalizumab 500 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917877|NCT00648739|OG001|Outcome|Samalizumab 600 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
11174742|NCT02024646|OG002|Outcome|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
11357579|NCT03755661|EG000|Reported Event|Intervention|"This intervention arm is a combined in-person text messaging intervention~MI&TXT4MSM: brief in-person intervention followed by text messaging~No adverse events"
11357580|NCT03755661|EG001|Reported Event|Assessment Only Control|"The is the assessment only comparison condition~No adverse events"
10917878|NCT00648739|EG000|Reported Event|Samalizumab 50 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917879|NCT00648739|EG001|Reported Event|Samalizumab 100 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917880|NCT00648739|EG002|Reported Event|Samalizumab 200 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917881|NCT00648739|EG003|Reported Event|Samalizumab 300 mg/m^2|Participants assigned to this dose cohort received a single IV 300 mg/m^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917882|NCT00648739|EG004|Reported Event|Samalizumab 400 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917883|NCT00648739|EG005|Reported Event|Samalizumab 500 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917884|NCT00648739|EG006|Reported Event|Samalizumab 600 mg/m^2|Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
10917885|NCT00648908|BG000|Baseline|Fampridine-SR|Tablets, 10mg twice daily
10917886|NCT00648908|FG000|Participant Flow|Fampridine-SR|Tablets, 10mg twice daily
10917887|NCT00648908|OG000|Outcome|Fampridine-SR 10mg (Twice a Day)|
10917888|NCT00648908|OG000|Outcome|Fampridine-SR|Tablets, 10mg twice daily
10917889|NCT00648908|EG000|Reported Event|Fampridine-SR|Tablets, 10mg twice daily
10917890|NCT00649220|BG000|Baseline|Memantine|Memantine tablets, twice a day (bid).
10917891|NCT00649220|FG000|Participant Flow|Memantine|Memantine tablets, twice a day (bid).
10917892|NCT00649220|OG000|Outcome|Memantine|Memantine tablets, twice a day (bid).
10917893|NCT00649220|EG000|Reported Event|Memantine|Memantine tablets, twice a day (bid).
10917894|NCT00649389|BG000|Baseline|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
10917895|NCT00649389|BG001|Baseline|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
10917896|NCT00649389|BG002|Baseline|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
10917897|NCT00649389|BG003|Baseline|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
10917898|NCT00649389|BG004|Baseline|Total|Total of all reporting groups
10917899|NCT00649389|FG000|Participant Flow|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
10917900|NCT00649389|FG001|Participant Flow|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
10917901|NCT00649389|FG002|Participant Flow|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
10917902|NCT00649389|FG003|Participant Flow|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
10917903|NCT00649389|OG000|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
10917904|NCT00649389|OG001|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
10917905|NCT00649389|OG002|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
10917906|NCT00649389|OG003|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
10917907|NCT00649389|EG000|Reported Event|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
10917908|NCT00649389|EG001|Reported Event|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
10917909|NCT00649389|EG002|Reported Event|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
10917910|NCT00649389|EG003|Reported Event|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
10917911|NCT00649428|BG000|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
10917912|NCT00649428|BG001|Baseline|Placebo|Patients treated with placebo solution
10917913|NCT00649428|BG002|Baseline|Total|Total of all reporting groups
10917914|NCT00649428|FG000|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
10917915|NCT00649428|FG001|Participant Flow|Placebo|Patients treated with placebo solution
10917916|NCT00649428|OG000|Outcome|Autologous Fibroblast|Patients treated with autologous fibroblasts (azficel-T).
10917917|NCT00649428|OG001|Outcome|Placebo|Patients treated with placebo solution.
10917918|NCT00649428|OG000|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
10917919|NCT00649428|EG000|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
10917920|NCT00649428|EG001|Reported Event|Placebo|Patients treated with placebo solution.
10917921|NCT00649792|BG000|Baseline|Fampridine-SR|Tablets, 10 mg, BID
10917922|NCT00649792|FG000|Participant Flow|Fampridine-SR|Tablets, 10 mg, BID
10917923|NCT00649792|OG000|Outcome|Fampridine-SR|Tablets, 10 mg, BID
10917924|NCT00649792|EG000|Reported Event|Fampridine-SR|Tablets, 10 mg, BID
10917925|NCT00649961|BG000|Baseline|Single Arm|Open label dose finding study in infants born before 31 weeks gestation and less than 7 days of age
10917926|NCT00649961|FG000|Participant Flow|Melatonin Open Label Single Arm|Open label single arm study, infant born less than 31 weeks gestation and less than 7 days old
10917927|NCT00649961|OG000|Outcome|Single Arm|open label dose finding study
10917928|NCT00649961|EG000|Reported Event|Single Arm|open label dose finding study
10917929|NCT00650078|BG000|Baseline|NP01|Modified Release (MR) prednisone 5 mg
10917930|NCT00650078|BG001|Baseline|Placebo|
10917931|NCT00650078|BG002|Baseline|Total|Total of all reporting groups
10917932|NCT00650078|FG000|Participant Flow|NP01|Modified Release (MR) prednisone 5 mg
10917933|NCT00650078|FG001|Participant Flow|Placebo|
10917934|NCT00650078|OG000|Outcome|NP01|Modified Release (MR) prednisone 5 mg
10917935|NCT00650078|OG001|Outcome|Placebo|
10917936|NCT00650078|EG000|Reported Event|NP01|Modified Release (MR) prednisone 5 mg
10917937|NCT00650078|EG001|Reported Event|Placebo|
10917938|NCT00650091|BG000|Baseline|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
10917939|NCT00650091|BG001|Baseline|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
10917940|NCT00650091|BG002|Baseline|Total|Total of all reporting groups
10917941|NCT00650091|FG000|Participant Flow|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
10917942|NCT00650091|FG001|Participant Flow|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
10917943|NCT00650091|FG002|Participant Flow|Pred/AZA/NAC|"The prednisone dose was started at 0.5 mg per kilo- gram of ideal body weight and was tapered to 0.15 mg per kilogram during a period of 25 weeks.~The azathioprine dose (maximum, 150 mg per day) was based on the patient's ideal weight, concurrent use of allopurinol, and thiopurine methyl-transferase (TPMT) activity. NAC was prescribed at 600 mg orally three times a day."
10917944|NCT00650091|OG000|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
10917945|NCT00650091|OG001|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
10917946|NCT00650091|EG000|Reported Event|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
10917947|NCT00650091|EG001|Reported Event|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
10917948|NCT00650091|EG002|Reported Event|Initial Study: Pred/AZA/NAC|Participants will receive prednisone, azathioprine, and N-acetylcysteine (NAC) for 60 weeks.
10917949|NCT00650091|EG003|Reported Event|Initial Study: Placebo|Placebo: Participants will receive placebo each day.
10917950|NCT00650104|BG000|Baseline|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
10917951|NCT00650104|FG000|Participant Flow|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
10963150|NCT00870545|OG000|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
10917952|NCT00650104|OG000|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
10917953|NCT00650104|EG000|Reported Event|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
10917954|NCT00650260|BG000|Baseline|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
10917955|NCT00650260|BG001|Baseline|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
10917956|NCT00650260|BG002|Baseline|Total|Total of all reporting groups
10917957|NCT00650260|FG000|Participant Flow|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
10917958|NCT00650260|FG001|Participant Flow|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
10917959|NCT00650260|OG000|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
10917960|NCT00650260|OG001|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
10963151|NCT00870545|EG000|Reported Event|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND~Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
11174743|NCT02024646|EG000|Reported Event|210 mg Brodalumab|"Administered via subcutaneous injections.~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection."
10917961|NCT00650260|EG000|Reported Event|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
10917962|NCT00650260|EG001|Reported Event|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
10917963|NCT00650546|BG000|Baseline|Open-labeled Prospective Case Series|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide: 5 mcg twice a day titrated to 10 mcg twice a day"
10917964|NCT00650546|FG000|Participant Flow|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
10917965|NCT00650546|OG000|Outcome|Treatment With Exenatide|eight adult patients with known type 2 DM and biopsy proven NAFLD
10917966|NCT00650546|OG000|Outcome|Individuals Who Recieved Treatment With Exenatide|change of NAS score in eight adult patients with known type 2 DM and biopsy proven NAFLD after treatment with exenatide
10917967|NCT00650546|EG000|Reported Event|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
10917968|NCT00650585|BG000|Baseline|Control Group|School did not receive Project ALERT, a substance use prevention program
10917969|NCT00650585|BG001|Baseline|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
10917970|NCT00650585|BG002|Baseline|Total|Total of all reporting groups
10917971|NCT00650585|FG000|Participant Flow|Control Group|School did not receive Project ALERT, a substance use prevention program
10917972|NCT00650585|FG001|Participant Flow|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
10917973|NCT00650585|OG000|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
10917974|NCT00650585|OG001|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
10917975|NCT00650585|EG000|Reported Event|Control Group|School did not receive Project ALERT, a substance use prevention program
10917976|NCT00650585|EG001|Reported Event|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
10917977|NCT00650767|BG000|Baseline|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
10917978|NCT00650767|BG001|Baseline|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917979|NCT00650767|BG002|Baseline|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917980|NCT00650767|BG003|Baseline|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917981|NCT00650767|BG004|Baseline|Total|Total of all reporting groups
10917982|NCT00650767|FG000|Participant Flow|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
10917983|NCT00650767|FG001|Participant Flow|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917984|NCT00650767|FG002|Participant Flow|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917985|NCT00650767|FG003|Participant Flow|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917986|NCT00650767|OG000|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
10917987|NCT00650767|OG001|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917988|NCT00650767|OG002|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917989|NCT00650767|OG003|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917990|NCT00650767|EG000|Reported Event|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
10917991|NCT00650767|EG001|Reported Event|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917992|NCT00650767|EG002|Reported Event|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917993|NCT00650767|EG003|Reported Event|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
10917994|NCT00650806|BG000|Baseline|Placebo|Each patient received matching placebo once daily for 12 weeks.
10917995|NCT00650806|BG001|Baseline|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
11174744|NCT02024646|EG001|Reported Event|140 mg Brodalumab|"Administered via subcutaneous injection.~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection."
10917996|NCT00650806|BG002|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10917997|NCT00650806|BG003|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10917998|NCT00650806|BG004|Baseline|Total|Total of all reporting groups
10917999|NCT00650806|FG000|Participant Flow|Placebo|Each patient received matching placebo once daily for 12 weeks.
10918000|NCT00650806|FG001|Participant Flow|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918001|NCT00650806|FG002|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918002|NCT00650806|FG003|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canaliflozin (JNJ-28431754) once daily for 12 weeks.
10918003|NCT00650806|OG000|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
11174745|NCT02024646|EG002|Reported Event|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
10918004|NCT00650806|OG001|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918005|NCT00650806|OG002|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918006|NCT00650806|OG003|Outcome|Canaglifloziin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918007|NCT00650806|OG003|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918008|NCT00650806|OG001|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918009|NCT00650806|EG000|Reported Event|Placebo|Each patient received matching placebo once daily for 12 weeks.
10918010|NCT00650806|EG001|Reported Event|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918011|NCT00650806|EG002|Reported Event|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918012|NCT00650806|EG003|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
10918013|NCT00650845|BG000|Baseline|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
10918014|NCT00650845|BG001|Baseline|Non-enhanced MRI|non-enhanced MRI: non injected MRI
10918015|NCT00650845|BG002|Baseline|Total|Total of all reporting groups
10918016|NCT00650845|FG000|Participant Flow|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
10918017|NCT00650845|FG001|Participant Flow|Non-enhanced MRI|non-enhanced MRI: non injected MRI
10918018|NCT00650845|OG000|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
10918019|NCT00650845|OG001|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
10918020|NCT00650845|OG000|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
10918021|NCT00650845|EG000|Reported Event|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
10918022|NCT00650845|EG001|Reported Event|Non-enhanced MRI|non-enhanced MRI: non injected MRI
10918023|NCT00650858|BG000|Baseline|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
10918024|NCT00650858|BG001|Baseline|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
10918025|NCT00650858|BG002|Baseline|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
10918026|NCT00650858|BG003|Baseline|Total|Total of all reporting groups
10918027|NCT00650858|FG000|Participant Flow|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
10918028|NCT00650858|FG001|Participant Flow|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
10918029|NCT00650858|FG002|Participant Flow|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
10918030|NCT00650858|OG000|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
10918031|NCT00650858|OG001|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
10918032|NCT00650858|OG002|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
10918033|NCT00650858|EG000|Reported Event|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
10918034|NCT00650858|EG001|Reported Event|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
10918035|NCT00650858|EG002|Reported Event|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
10918036|NCT00650936|BG000|Baseline|AMPLATZER Septal Occluder|The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
10918037|NCT00650936|FG000|Participant Flow|AMPLATZER Septal Occluder|The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
10918038|NCT00650936|OG000|Outcome|AMPLATZER Septal Occluder|The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
10918039|NCT00650936|EG000|Reported Event|AMPLATZER Septal Occluder|"Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).~AMPLATZER Septal Occluder: AMPLATZER Septal Occluder"
10918040|NCT00651040|BG000|Baseline|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
11174746|NCT02024698|BG000|Baseline|Overall Study Group|Study participants are randomized to wear omafilcon A or etafilcon A pair of study lenses then crossover to the alternate pair.
11174747|NCT02024698|FG000|Participant Flow|Etafilcon A First, Then Omafilcon A|Study participants are randomized to wear etafilcon A pair of study lenses then crossover to the alternate pair.
11174748|NCT02024698|FG001|Participant Flow|Omafilcon A First, Then Etafilcon A|Study participants are randomized to wear omafilcon A pair of study lenses then crossover to the alternate pair.
11174749|NCT02024698|OG000|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
10963152|NCT00870584|BG000|Baseline|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
10963153|NCT00870584|BG001|Baseline|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
11174750|NCT02024698|OG001|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
10918041|NCT00651040|BG001|Baseline|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
10918042|NCT00651040|BG002|Baseline|Total|Total of all reporting groups
10918043|NCT00651040|FG000|Participant Flow|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
10918044|NCT00651040|FG001|Participant Flow|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
10918045|NCT00651040|OG000|Outcome|Prednison1|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
10918046|NCT00651040|OG001|Outcome|Prednison Methotrexate 2|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
10918047|NCT00651040|EG000|Reported Event|1 Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
10918048|NCT00651040|EG001|Reported Event|2 Prednison Methotrexate|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
10918049|NCT00651118|BG000|Baseline|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
10918050|NCT00651118|BG001|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
10918051|NCT00651118|BG002|Baseline|Azelastine HCl|azelastine HCl nasal spray nasal spray
10918052|NCT00651118|BG003|Baseline|Placebo|placebo nasal spray
10918053|NCT00651118|BG004|Baseline|Total|Total of all reporting groups
10918054|NCT00651118|FG000|Participant Flow|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
10918055|NCT00651118|FG001|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
10918056|NCT00651118|FG002|Participant Flow|Azelastine HCl|azelastine HCl nasal spray nasal spray
10918057|NCT00651118|FG003|Participant Flow|Placebo|placebo nasal spray
10918058|NCT00651118|OG000|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
10918059|NCT00651118|OG001|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
10918060|NCT00651118|OG002|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
10918061|NCT00651118|OG003|Outcome|Placebo|placebo nasal spray
10918062|NCT00651118|OG000|Outcome|MP29-02|fluticasone propionate 50 mcg / azelastine HCl 137 mcg nasal spray
10918063|NCT00651118|OG002|Outcome|Azelastine HCl|azelastine HCl nasal spray
10918064|NCT00651118|OG003|Outcome|Placebo|Placebo nasal spray
10918065|NCT00651118|EG000|Reported Event|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
10918066|NCT00651118|EG001|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
10918067|NCT00651118|EG002|Reported Event|Azelastine HCl|azelastine HCl nasal spray nasal spray
10918068|NCT00651118|EG003|Reported Event|Placebo|placebo nasal spray
10918069|NCT00651157|BG000|Baseline|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV administered at a dose of 3 x 10^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10918070|NCT00651157|FG000|Participant Flow|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10918071|NCT00651157|OG000|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10918072|NCT00651157|EG000|Reported Event|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10918073|NCT00651183|BG000|Baseline|Early PD|Early Parkinson's Disease (PD) patients
10918074|NCT00651183|BG001|Baseline|Advanced PD|Advanced Parkinson's Disease (PD) patients
10918075|NCT00651183|BG002|Baseline|Total|Total of all reporting groups
10918076|NCT00651183|FG000|Participant Flow|Early (PD)|Early Parkinson's Disease (PD) patients
10918077|NCT00651183|FG001|Participant Flow|Advanced PD|Advanced Parkinson's Disease (PD) patients
10918078|NCT00651183|OG000|Outcome|Early PD|Early Parkinson's Disease (PD) patients
10918079|NCT00651183|OG001|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
10918080|NCT00651183|EG000|Reported Event|Early PD|Early Parkinson's Disease (PD) patients
10918081|NCT00651183|EG001|Reported Event|Advanced PD|Advanced Parkinson's Disease (PD) patients
10918082|NCT00651261|BG000|Baseline|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
10918083|NCT00651261|BG001|Baseline|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
10918084|NCT00651261|BG002|Baseline|Total|Total of all reporting groups
10918085|NCT00651261|FG000|Participant Flow|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
10918086|NCT00651261|FG001|Participant Flow|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
10918087|NCT00651261|OG000|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
10918088|NCT00651261|OG001|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
10918089|NCT00651261|EG000|Reported Event|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
10918090|NCT00651261|EG001|Reported Event|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
10918091|NCT00651313|BG000|Baseline|Active|Lidocaine 10% (150mg) vaginal gel
10918092|NCT00651313|BG001|Baseline|Placebo|Placebo vaginal gel
10918093|NCT00651313|BG002|Baseline|Total|Total of all reporting groups
10918094|NCT00651313|FG000|Participant Flow|Active|Lidocaine 10% (150mg) vaginal gel
10918095|NCT00651313|FG001|Participant Flow|Placebo|Placebo vaginal gel
10918096|NCT00651313|OG000|Outcome|Lidocaine 10%|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
10918097|NCT00651313|OG001|Outcome|Placebo Gel|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
10918098|NCT00651313|EG000|Reported Event|Active|Lidocaine 10% (150mg) vaginal gel
10918099|NCT00651313|EG001|Reported Event|Placebo|Placebo vaginal gel
10963154|NCT00870584|BG002|Baseline|Total|Total of all reporting groups
10963155|NCT00870584|FG000|Participant Flow|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
10963156|NCT00870584|FG001|Participant Flow|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
10963157|NCT00870584|OG000|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
10963158|NCT00870584|OG001|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
11174751|NCT02024698|EG000|Reported Event|Omafilcon A|Study participants are randomized to wear omafilcon A lenses.
11174752|NCT02024698|EG001|Reported Event|Etafilcon A|Study participants are randomized to wear etafilcon A lenses.
10918100|NCT00651482|BG000|Baseline|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
10918101|NCT00651482|FG000|Participant Flow|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
10918102|NCT00651482|OG000|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
10918103|NCT00651482|OG000|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
10918104|NCT00651482|EG000|Reported Event|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
10918105|NCT00651573|BG000|Baseline|Blood Transfusion Triggers of 24% Hematocrit Value|Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
10918106|NCT00651573|BG001|Baseline|Blood Transfusion Triggers of 28% Hematocrit Value|Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
10918107|NCT00651573|BG002|Baseline|Total|Total of all reporting groups
11174753|NCT02024711|BG000|Baseline|EYEFILL® C.-US Viscoelastic|"EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.~EYEFILL® C.-US Viscoelastic: EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries."
10918108|NCT00651573|FG000|Participant Flow|Blood Transfusion Triggers of 24% Hematocrit Value|Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
10918109|NCT00651573|FG001|Participant Flow|Blood Transfusion Triggers of 28% Hematocrit Value|Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
10918110|NCT00651573|OG000|Outcome|Blood Transfusion Triggers of 24% Hematocrit Value|Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
10918111|NCT00651573|OG001|Outcome|Blood Transfusion Triggers of 28% Hematocrit Value|Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
10918112|NCT00651573|EG000|Reported Event|Blood Transfusion Triggers of 24% Hematocrit Value|Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
10918113|NCT00651573|EG001|Reported Event|Blood Transfusion Triggers of 28% Hematocrit Value|Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
10918114|NCT00651625|BG000|Baseline|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
10918115|NCT00651625|BG001|Baseline|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
10918116|NCT00651625|BG002|Baseline|Total|Total of all reporting groups
10918117|NCT00651625|FG000|Participant Flow|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
10918118|NCT00651625|FG001|Participant Flow|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
10918119|NCT00651625|OG000|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
10918120|NCT00651625|OG001|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
10918121|NCT00651625|EG000|Reported Event|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
10918122|NCT00651625|EG001|Reported Event|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
10918123|NCT00651664|BG000|Baseline|Alisertib 5 mg QD 7D|Alisertib 5 mg, capsules, orally, once daily (QD) for 7 days (D) followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles).
10918124|NCT00651664|BG001|Baseline|Alisertib 80 mg QD 7D|Alisertib 80 mg, capsules, orally, QD for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).
10918125|NCT00651664|BG002|Baseline|Alisertib 150 mg QD 7D|Alisertib 150 mg, capsules, orally, QD for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10918126|NCT00651664|BG003|Baseline|Alisertib 50 mg BID 7D|Alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 29 cycles).
10918127|NCT00651664|BG004|Baseline|Alisertib 60 mg BID 7D|Alisertib 60 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
11174754|NCT02024711|BG001|Baseline|Healon® Viscoelastic (CONTROL)|"Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.~Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries."
11174755|NCT02024711|BG002|Baseline|Total|Total of all reporting groups
11174756|NCT02024711|FG000|Participant Flow|EYEFILL® C.-US Viscoelastic|"EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.~EYEFILL® C.-US Viscoelastic: EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries."
11174757|NCT02024711|FG001|Participant Flow|Healon® Viscoelastic (CONTROL)|"Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.~Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries."
10918128|NCT00651664|BG005|Baseline|Alisertib 75 mg BID 7D|Alisertib 75 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).
10918129|NCT00651664|BG006|Baseline|Alisertib 100 mg BID 7D|Alisertib 100 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 21 cycles).
10918130|NCT00651664|BG007|Baseline|Alisertib 50 mg QD 14D|Alisertib 50 mg, capsules, orally, QD for 14 days followed by a 14-day recovery period in each 28-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 25 cycles).
10918131|NCT00651664|BG008|Baseline|Alisertib 50 mg QD 21D|Alisertib 50 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 10 cycles).
10918132|NCT00651664|BG009|Baseline|Alisertib 70 mg QD 21D|Alisertib 70 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10918133|NCT00651664|BG010|Baseline|Total|Total of all reporting groups
10918134|NCT00651664|FG000|Participant Flow|Alisertib 5 mg QD 7D|Alisertib 5 mg, capsules, orally, once daily (QD) for 7 days (D) followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles).
10918135|NCT00651664|FG001|Participant Flow|Alisertib 80 mg QD 7D|Alisertib 80 mg, capsules, orally, QD for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).
10918136|NCT00651664|FG002|Participant Flow|Alisertib 150 mg QD 7D|Alisertib 150 mg, capsules, orally, QD for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10918137|NCT00651664|FG003|Participant Flow|Alisertib 50 mg BID 7D|Alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 29 cycles).
11174758|NCT02024711|OG000|Outcome|EYEFILL® C.-US Viscoelastic|"EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.~EYEFILL® C.-US Viscoelastic: EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries."
11174759|NCT02024711|OG001|Outcome|Healon® Viscoelastic (CONTROL)|"Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.~Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries."
11174760|NCT02024711|EG000|Reported Event|EYEFILL® C.-US Viscoelastic|"EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.~EYEFILL® C.-US Viscoelastic: EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries."
11174761|NCT02024711|EG001|Reported Event|Healon® Viscoelastic (CONTROL)|"Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.~Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries."
11174762|NCT02024724|BG000|Baseline|Group 2|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
11174763|NCT02024724|BG001|Baseline|Group 1|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
11174764|NCT02024724|BG002|Baseline|Total|Total of all reporting groups
11174765|NCT02024724|FG000|Participant Flow|Group 2|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
11174766|NCT02024724|FG001|Participant Flow|Group 1|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
11174767|NCT02024724|OG000|Outcome|Group 1|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
11174768|NCT02024724|OG001|Outcome|Group 2|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
11174769|NCT02024724|EG000|Reported Event|Group 1|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
11174770|NCT02024724|EG001|Reported Event|Group 2|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
11174771|NCT02024750|BG000|Baseline|Tailored Resources|Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey
10918138|NCT00651664|FG004|Participant Flow|Alisertib 60 mg BID 7D|Alisertib 60 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10918139|NCT00651664|FG005|Participant Flow|Alisertib 75 mg BID 7D|Alisertib 75 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).
10918140|NCT00651664|FG006|Participant Flow|Alisertib 100 mg BID 7D|Alisertib 100 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 21 cycles).
10918141|NCT00651664|FG007|Participant Flow|Alisertib 50 mg QD 14D|Alisertib 50 mg, capsules, orally, QD for 14 days followed by a 14-day recovery period in each 28-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 25 cycles).
10918142|NCT00651664|FG008|Participant Flow|Alisertib 50 mg QD 21D|Alisertib 50 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 10 cycles).
10918143|NCT00651664|FG009|Participant Flow|Alisertib 70 mg QD 21D|Alisertib 70 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10918144|NCT00651664|OG000|Outcome|Alisertib 5 mg QD 7D|Alisertib 5 mg, capsules, orally, once daily (QD) for 7 days (D) followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles).
10918145|NCT00651664|OG001|Outcome|Alisertib 80 mg QD 7D|Alisertib 80 mg, capsules, orally, QD for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).
10918146|NCT00651664|OG002|Outcome|Alisertib 150 mg QD 7D|Alisertib 150 mg, capsules, orally, QD for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10918147|NCT00651664|OG003|Outcome|Alisertib 50 mg BID 7D|Alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 29 cycles).
10918148|NCT00651664|OG004|Outcome|Alisertib 60 mg BID 7D|Alisertib 60 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10918149|NCT00651664|OG005|Outcome|Alisertib 75 mg BID 7D|Alisertib 75 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).
10918150|NCT00651664|OG006|Outcome|Alisertib 100 mg BID 7D|Alisertib 100 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 21 cycles).
10918151|NCT00651664|OG007|Outcome|Alisertib 50 mg QD 14D|Alisertib 50 mg, capsules, orally, QD for 14 days followed by a 14-day recovery period in each 28-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 25 cycles).
10918152|NCT00651664|OG008|Outcome|Alisertib 50 mg QD 21D|Alisertib 50 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 10 cycles).
11174772|NCT02024750|BG001|Baseline|Usual Care|Routine multidisciplinary diabetes care
10918153|NCT00651664|OG009|Outcome|Alisertib 70 mg QD 21D|Alisertib 70 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10918154|NCT00651664|OG000|Outcome|Alisertib|Alisertib 5, 80 or 150 mg, capsules, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 50, 60, 75 or 100 mg, capsules, orally, twice daily (BID) for 7 days, followed by a 14-day recovery period or alisertib 50 mg, capsules, orally, QD for 14 days followed by a 14-day recovery period or alisertib 50 or 70 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 29 cycles).
10918155|NCT00651664|OG000|Outcome|Alisertib 50 mg QD 14D|Alisertib 50 mg, capsules, orally, QD for 14 days followed by a 14-day recovery period in each 28-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 25 cycles).
10918156|NCT00651664|OG000|Outcome|Alisertib 50 mg QD 21D|Alisertib 50 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 10 cycles).
10918157|NCT00651664|OG001|Outcome|Alisertib 70 mg QD 21D|Alisertib 70 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10918158|NCT00651664|EG000|Reported Event|Alisertib 5 mg QD 7D|Alisertib 5 mg, capsules, orally, once daily (QD) for 7 days (D) followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles).
11174773|NCT02024750|BG002|Baseline|Total|Total of all reporting groups
11174774|NCT02024750|FG000|Participant Flow|Tailored Resources|Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey
11174775|NCT02024750|FG001|Participant Flow|Usual Care|Routine multidisciplinary diabetes care
11174776|NCT02024750|OG000|Outcome|Usual Care|Participants who received usual care.
10918159|NCT00651664|EG001|Reported Event|Alisertib 80 mg QD 7D|Alisertib 80 mg, capsules, orally, QD for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).
10918160|NCT00651664|EG002|Reported Event|Alisertib 150 mg QD 7D|Alisertib 150 mg, capsules, orally, QD for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10918161|NCT00651664|EG003|Reported Event|Alisertib 50 mg BID 7D|Alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 29 cycles).
10918162|NCT00651664|EG004|Reported Event|Alisertib 60 mg BID 7D|Alisertib 60 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).
10918163|NCT00651664|EG005|Reported Event|Alisertib 75 mg BID 7D|Alisertib 75 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).
10918164|NCT00651664|EG006|Reported Event|Alisertib 100 mg BID 7D|Alisertib 100 mg, capsules, orally, BID for 7 days followed by a 14-day recovery period in each 21-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 21 cycles).
11174777|NCT02024750|OG001|Outcome|Tailored Resources|Participants who received tailored resources.
10918165|NCT00651664|EG007|Reported Event|Alisertib 50 mg QD 14D|Alisertib 50 mg, capsules, orally, QD for 14 days followed by a 14-day recovery period in each 28-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 25 cycles).
10918166|NCT00651664|EG008|Reported Event|Alisertib 50 mg QD 21D|Alisertib 50 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 10 cycles).
10918167|NCT00651664|EG009|Reported Event|Alisertib 70 mg QD 21D|Alisertib 70 mg, capsules, orally, QD for 21 days followed by a 14-day recovery period in each 35-day cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10918168|NCT00651755|BG000|Baseline|Entire Study Population|Participants randomized to Aprepitant or control (Standard of Care) in Cycle 1 crossover for different treatment in Cycle 2.
10918169|NCT00651755|FG000|Participant Flow|First Aprepitant Cycle 1 Then No Aprepitant Cycle 2|"First Aprepitant with CHOP or R-CHOP (CHOP plus Rituximab 375 mg/m^2 intravenous Day 1) then No Aprepitant in Cycle 2.~Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above]."
10918170|NCT00651755|FG001|Participant Flow|First No Aprepritant Cycle 1, Then Aprepitant Cycle 2|First No Aprepitant in Cycle 1, then Aprepitant 125 mg oral (PO) Day 1 of Cycle 2 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above].
10918171|NCT00651755|OG000|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
10918172|NCT00651755|OG001|Outcome|Control Group|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
10918173|NCT00651755|OG001|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
10918174|NCT00651755|EG000|Reported Event|Aprepitant|Aprepitant 125 mg oral (PO) Day 1 (Cycle 1 or Cycle 2) to include treated study population.
10918175|NCT00651755|EG001|Reported Event|Control|Standard of Care
10918176|NCT00651794|BG000|Baseline|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
10918177|NCT00651794|BG001|Baseline|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
10918178|NCT00651794|BG002|Baseline|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
10918179|NCT00651794|BG003|Baseline|Total|Total of all reporting groups
10918180|NCT00651794|FG000|Participant Flow|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
10918181|NCT00651794|FG001|Participant Flow|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
10918182|NCT00651794|FG002|Participant Flow|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
10918183|NCT00651794|OG000|Outcome|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
10918184|NCT00651794|OG001|Outcome|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
10918185|NCT00651794|OG002|Outcome|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
10918186|NCT00651794|EG000|Reported Event|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
10918187|NCT00651794|EG001|Reported Event|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
10918188|NCT00651794|EG002|Reported Event|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
10918189|NCT00651820|BG000|Baseline|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
10918190|NCT00651820|FG000|Participant Flow|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
10918191|NCT00651820|OG000|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
10918192|NCT00651820|OG001|Outcome|Vehicle Rate to Complete Wound Healing|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
10918193|NCT00651820|OG001|Outcome|Vehicle Rate of Wound Closure|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
10918194|NCT00651820|EG000|Reported Event|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
10918195|NCT00651924|BG000|Baseline|Phase 1|Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are.
10918196|NCT00651924|BG001|Baseline|Phase 2|Pilot IVR-based Cognitive-behavior therapy: Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
10918197|NCT00651924|BG002|Baseline|Total|Total of all reporting groups
10918198|NCT00651924|FG000|Participant Flow|Phase 1|Review of materials and provide feedback regarding how understandable, engaging, and informative the materials are. Revisions will be made based on this feedback.
10918199|NCT00651924|FG001|Participant Flow|Phase 2|Undergo IVR-based Cognitive Behavioral Therapy treatment using the new materials.
10918200|NCT00651924|OG000|Outcome|Phase 1|Qualitative interviews
11174778|NCT02024750|EG000|Reported Event|Tailored Resources|Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey.
11174779|NCT02024750|EG001|Reported Event|Usual Care|Routine multidisciplinary diabetes care
11174780|NCT02024867|BG000|Baseline|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
11174781|NCT02024867|BG001|Baseline|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
10918201|NCT00651924|OG001|Outcome|Phase 2|Pilot IVR-based CBT treatment
10918202|NCT00651924|EG000|Reported Event|Phase 1|Review of newly created materials and provide feedback regarding how understandable, engaging, and informative the materials are.
10918203|NCT00651924|EG001|Reported Event|Phase 2|Pilot the newly developed materials during a 10-week course of cognitive behavioral therapy for chronic pain
10918204|NCT00651937|BG000|Baseline|Standard Dose Stem Cell Group|Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive either a standard (4-6×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
10918205|NCT00651937|BG001|Baseline|High Dose Stem Cell Group|Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive high dose (10-15×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
10918206|NCT00651937|BG002|Baseline|Total|Total of all reporting groups
11174782|NCT02024867|BG002|Baseline|Total|Total of all reporting groups
11174783|NCT02024867|FG000|Participant Flow|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
10918207|NCT00651937|FG000|Participant Flow|Standard Dose Stem Cell Group|Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive either a standard (4-6×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
10918208|NCT00651937|FG001|Participant Flow|High Dose Stem Cell Group|Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive high dose (10-15×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
10918209|NCT00651937|OG000|Outcome|Standard Dose Stem Cell Group|Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive either a standard (4-6×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
10918210|NCT00651937|OG001|Outcome|High Dose Stem Cell Group|Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive high dose (10-15×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
10918211|NCT00651937|EG000|Reported Event|Standard Dose Stem Cell Group|Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive either a standard (4-6×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
11174784|NCT02024867|FG001|Participant Flow|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
11174785|NCT02024867|OG000|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
10918212|NCT00651937|EG001|Reported Event|High Dose Stem Cell Group|Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive high dose (10-15×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
10918213|NCT00652028|BG000|Baseline|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
10918214|NCT00652028|BG001|Baseline|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
10918215|NCT00652028|BG002|Baseline|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
10918216|NCT00652028|BG003|Baseline|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
10918217|NCT00652028|BG004|Baseline|Total|Total of all reporting groups
10918218|NCT00652028|FG000|Participant Flow|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
10918219|NCT00652028|FG001|Participant Flow|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
10918220|NCT00652028|FG002|Participant Flow|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
10918221|NCT00652028|FG003|Participant Flow|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
10918222|NCT00652028|OG000|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
10918223|NCT00652028|OG001|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
11174786|NCT02024867|OG001|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
11174787|NCT02024867|EG000|Reported Event|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
11174788|NCT02024867|EG001|Reported Event|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
10918224|NCT00652028|OG002|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
10918225|NCT00652028|OG003|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
10918226|NCT00652028|EG000|Reported Event|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
10918227|NCT00652028|EG001|Reported Event|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
10918228|NCT00652028|EG002|Reported Event|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
10918229|NCT00652028|EG003|Reported Event|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
10918230|NCT00652080|BG000|Baseline|API 31510 Topical Cream|"Active Cream 3%; AM & PM~API 31510: Topical Cream; 3% active; AM & PM application"
10918231|NCT00652080|FG000|Participant Flow|API 31510 Topical Cream|"Active Cream 3%; AM & PM~API 31510: Topical Cream; 3% active; AM & PM application"
10918232|NCT00652080|OG000|Outcome|Safety Population|"Active Cream 3%; AM & PM~API 31510: Topical Cream; 3% active; AM & PM application"
10918233|NCT00652080|OG000|Outcome|ITT Population|"Active Cream 3%; AM & PM~API 31510: Topical Cream; 3% active; AM & PM application"
11174789|NCT02024932|BG000|Baseline|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
10918234|NCT00652080|OG001|Outcome|PP Population|"Active Cream 3%; AM & PM~API 31510: Topical Cream; 3% active; AM & PM application"
10918235|NCT00652080|EG000|Reported Event|1 Safety Population|"Active Cream 3%; AM & PM~API 31510: Topical Cream; 3% active; AM & PM application"
10918236|NCT00652093|BG000|Baseline|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
10918237|NCT00652093|BG001|Baseline|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
10918238|NCT00652093|BG002|Baseline|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
10918239|NCT00652093|BG003|Baseline|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
10918240|NCT00652093|BG004|Baseline|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
10918241|NCT00652093|BG005|Baseline|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
10918242|NCT00652093|BG006|Baseline|Total|Total of all reporting groups
10918243|NCT00652093|FG000|Participant Flow|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
10918244|NCT00652093|FG001|Participant Flow|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
10918245|NCT00652093|FG002|Participant Flow|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
10918246|NCT00652093|FG003|Participant Flow|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
10918247|NCT00652093|FG004|Participant Flow|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
10918248|NCT00652093|FG005|Participant Flow|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
11174790|NCT02024932|BG001|Baseline|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
11174791|NCT02024932|BG002|Baseline|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
10918249|NCT00652093|OG000|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
10918250|NCT00652093|OG001|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
10918251|NCT00652093|OG002|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
10918252|NCT00652093|OG003|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
10918253|NCT00652093|OG004|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
10918254|NCT00652093|OG005|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
10918255|NCT00652093|EG000|Reported Event|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
10918256|NCT00652093|EG001|Reported Event|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
10918257|NCT00652093|EG002|Reported Event|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
10918258|NCT00652093|EG003|Reported Event|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
10918259|NCT00652093|EG004|Reported Event|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
10918260|NCT00652093|EG005|Reported Event|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
10918261|NCT00652145|BG000|Baseline|Increase Mesalamine Dose|Participants were randomized to increase dose of mesalamine by 2.4 gm per day over their baseline dose
10918262|NCT00652145|BG001|Baseline|Maintain Mesalamine Dose|Participants were randomized to maintain their baseline mesalamine dose
10918263|NCT00652145|BG002|Baseline|Total|Total of all reporting groups
10918264|NCT00652145|FG000|Participant Flow|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
10918265|NCT00652145|FG001|Participant Flow|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
10918266|NCT00652145|OG000|Outcome|Increase Mesalamine Dose by 2.4g/Day|"Increase dose of mesalamine by 2.4 gm per day~mesalamine: Increase dose by 2.4gm per day over baseline dose"
10918267|NCT00652145|OG001|Outcome|Maintain Mesalmine Dose|Maintain current mesalamine dose at 2.4 g/day
10918268|NCT00652145|OG000|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
10918269|NCT00652145|OG001|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
10918270|NCT00652145|EG000|Reported Event|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
10918271|NCT00652145|EG001|Reported Event|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
10918272|NCT00652314|BG000|Baseline|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
10918273|NCT00652314|BG001|Baseline|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
10918274|NCT00652314|BG002|Baseline|Total|Total of all reporting groups
10918275|NCT00652314|FG000|Participant Flow|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
10918276|NCT00652314|FG001|Participant Flow|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
10918277|NCT00652314|OG000|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
10918278|NCT00652314|OG001|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
10918279|NCT00652314|EG000|Reported Event|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
10918280|NCT00652314|EG001|Reported Event|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
10918281|NCT00652340|BG000|Baseline|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
10918282|NCT00652340|BG001|Baseline|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
10918283|NCT00652340|BG002|Baseline|Total|Total of all reporting groups
10918284|NCT00652340|FG000|Participant Flow|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
10918285|NCT00652340|FG001|Participant Flow|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
10918286|NCT00652340|OG000|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
10918287|NCT00652340|OG001|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
10918288|NCT00652340|EG000|Reported Event|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
10918289|NCT00652340|EG001|Reported Event|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
10918290|NCT00652366|BG000|Baseline|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918291|NCT00652366|BG001|Baseline|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
10918292|NCT00652366|BG002|Baseline|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918293|NCT00652366|BG003|Baseline|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918294|NCT00652366|BG004|Baseline|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
10918295|NCT00652366|BG005|Baseline|Total|Total of all reporting groups
10918296|NCT00652366|FG000|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918297|NCT00652366|FG001|Participant Flow|G+E Standard Dose: Rash Grade Less Than (<) 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
10918298|NCT00652366|FG002|Participant Flow|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 milligrams per day (mg/day), PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade ≥ 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
11174792|NCT02024932|BG003|Baseline|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
11174793|NCT02024932|BG004|Baseline|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
10918299|NCT00652366|FG003|Participant Flow|G+E: No Rash Non-Eligibl|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918300|NCT00652366|FG004|Participant Flow|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
10918301|NCT00652366|OG000|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
10918302|NCT00652366|OG001|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918303|NCT00652366|OG000|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months
10918304|NCT00652366|OG000|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918305|NCT00652366|OG001|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
10918306|NCT00652366|OG002|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918307|NCT00652366|OG000|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918308|NCT00652366|EG000|Reported Event|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
11174794|NCT02024932|BG005|Baseline|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
10918309|NCT00652366|EG001|Reported Event|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
10918310|NCT00652366|EG002|Reported Event|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918311|NCT00652366|EG003|Reported Event|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
10918312|NCT00652366|EG004|Reported Event|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
10918313|NCT00652626|BG000|Baseline|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
10918314|NCT00652626|BG001|Baseline|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
10918315|NCT00652626|BG002|Baseline|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
11174795|NCT02024932|BG006|Baseline|Total|Total of all reporting groups
11174796|NCT02024932|FG000|Participant Flow|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
11174797|NCT02024932|FG001|Participant Flow|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
11174798|NCT02024932|FG002|Participant Flow|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
11174799|NCT02024932|FG003|Participant Flow|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
11174800|NCT02024932|FG004|Participant Flow|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
11174801|NCT02024932|FG005|Participant Flow|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
11174802|NCT02024932|OG000|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
11174803|NCT02024932|OG001|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
11174804|NCT02024932|OG002|Outcome|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
11174805|NCT02024932|OG003|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
11174806|NCT02024932|OG004|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
11174807|NCT02024932|OG005|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
11174808|NCT02024932|OG000|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
11174809|NCT02024932|OG001|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
11174810|NCT02024932|OG000|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
11174811|NCT02024932|OG000|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
11174812|NCT02024932|OG002|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
11174813|NCT02024932|OG003|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
10918316|NCT00652626|BG003|Baseline|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
10918317|NCT00652626|BG004|Baseline|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918318|NCT00652626|BG005|Baseline|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
10918319|NCT00652626|BG006|Baseline|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
10918320|NCT00652626|BG007|Baseline|Total|Total of all reporting groups
10918321|NCT00652626|FG000|Participant Flow|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
10918322|NCT00652626|FG001|Participant Flow|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
10918323|NCT00652626|FG002|Participant Flow|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918324|NCT00652626|FG003|Participant Flow|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
10918325|NCT00652626|FG004|Participant Flow|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918326|NCT00652626|FG005|Participant Flow|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
10918327|NCT00652626|FG006|Participant Flow|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
10918328|NCT00652626|OG000|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
10918329|NCT00652626|OG001|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
10918330|NCT00652626|OG002|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918331|NCT00652626|OG003|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
10918332|NCT00652626|OG000|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918333|NCT00652626|OG001|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918334|NCT00652626|OG004|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918335|NCT00652626|OG005|Outcome|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
10918336|NCT00652626|OG006|Outcome|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
10918337|NCT00652626|EG000|Reported Event|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
10918338|NCT00652626|EG001|Reported Event|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
10918339|NCT00652626|EG002|Reported Event|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918340|NCT00652626|EG003|Reported Event|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
10918341|NCT00652626|EG004|Reported Event|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
10918342|NCT00652626|EG005|Reported Event|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
10918343|NCT00652626|EG006|Reported Event|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
10918344|NCT00652743|BG000|Baseline|GSK1562902A M6 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918345|NCT00652743|BG001|Baseline|GSK1562902A M12 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918346|NCT00652743|BG002|Baseline|GSK1562902A M36 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918347|NCT00652743|BG003|Baseline|Total|Total of all reporting groups
10918348|NCT00652743|FG000|Participant Flow|GSK1562902A M6 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918349|NCT00652743|FG001|Participant Flow|GSK1562902A M12 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918350|NCT00652743|FG002|Participant Flow|GSK1562902A M36 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918351|NCT00652743|OG000|Outcome|GSK1562902A M12 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918352|NCT00652743|OG000|Outcome|GSK1562902A M36 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918353|NCT00652743|OG000|Outcome|GSK1562902A M6 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918354|NCT00652743|OG001|Outcome|GSK1562902A M12 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918355|NCT00652743|OG002|Outcome|GSK1562902A M36 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918356|NCT00652743|OG001|Outcome|GSK1562902A M36 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918357|NCT00652743|EG000|Reported Event|GSK1562902A M6 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918358|NCT00652743|EG001|Reported Event|GSK1562902A M12 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918359|NCT00652743|EG002|Reported Event|GSK1562902A M36 Group|Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
10918360|NCT00652834|BG000|Baseline|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
10918361|NCT00652834|FG000|Participant Flow|Kidney Transplant Recipients With GI Symptoms|"Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
10918362|NCT00652834|OG000|Outcome|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
10918363|NCT00652834|EG000|Reported Event|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
10918364|NCT00652899|BG000|Baseline|All Patients Enrolled|This group includes all patients consented to participate in this study.
10918365|NCT00652899|FG000|Participant Flow|All Patients Enrolled|This group includes all patients consented to participate in this study.
10918366|NCT00652899|OG000|Outcome|Ovarian/Fallopian Tube/Peritoneal Cancer Patients|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and/or total body irradiation per protocol (200 Gy on Day 1 preceding natural killer cell infusion).
10918367|NCT00652899|OG000|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
10918368|NCT00652899|OG001|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
10918369|NCT00652899|OG000|Outcome|Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and total body irradiation per protocol.
10918370|NCT00652899|OG001|Outcome|No Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and no total body irradiation per protocol.
10918371|NCT00652899|EG000|Reported Event|All Patients Enrolled|This group includes all patients consented to participate in this study.
10918372|NCT00652938|BG000|Baseline|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
10918373|NCT00652938|BG001|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
10918374|NCT00652938|BG002|Baseline|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
10918375|NCT00652938|BG003|Baseline|Total|Total of all reporting groups
10918376|NCT00652938|FG000|Participant Flow|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
10918377|NCT00652938|FG001|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
10918378|NCT00652938|FG002|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
10918379|NCT00652938|OG000|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
10918380|NCT00652938|OG001|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
10918381|NCT00652938|OG002|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
10918382|NCT00652938|EG000|Reported Event|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
10918383|NCT00652938|EG001|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
10918384|NCT00652938|EG002|Reported Event|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
10918385|NCT00652951|BG000|Baseline|Synflorix + Infanrix Hexa Group|Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
10918386|NCT00652951|BG001|Baseline|Synflorix + Pediacel Group|Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
11174814|NCT02024932|EG000|Reported Event|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
11174815|NCT02024932|EG001|Reported Event|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
10918387|NCT00652951|BG002|Baseline|Prevenar + Pediacel Group|Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
10918388|NCT00652951|BG003|Baseline|Total|Total of all reporting groups
10918389|NCT00652951|FG000|Participant Flow|Synflorix + Infanrix Hexa Group|Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
10918390|NCT00652951|FG001|Participant Flow|Synflorix + Pediacel Group|Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
11174816|NCT02024932|EG002|Reported Event|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
10918391|NCT00652951|FG002|Participant Flow|Prevenar + Pediacel Group|Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
10918392|NCT00652951|OG000|Outcome|Synflorix + Infanrix Hexa Group|Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
10918393|NCT00652951|OG001|Outcome|Synflorix + Pediacel Group|Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
10918394|NCT00652951|OG002|Outcome|Prevenar + Pediacel Group|Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
10918395|NCT00652951|EG000|Reported Event|Synflorix + Infanrix Hexa Group|Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
10918396|NCT00652951|EG001|Reported Event|Synflorix + Pediacel Group|Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
11174817|NCT02024932|EG003|Reported Event|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
11174818|NCT02024932|EG004|Reported Event|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
11174819|NCT02024932|EG005|Reported Event|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
11174820|NCT02024971|BG000|Baseline|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
11174821|NCT02024971|FG000|Participant Flow|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
11174822|NCT02024971|OG000|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
11174823|NCT02024971|EG000|Reported Event|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
10918397|NCT00652951|EG002|Reported Event|Prevenar + Pediacel Group|Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
11174824|NCT02025075|BG000|Baseline|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
11174825|NCT02025075|BG001|Baseline|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
11174826|NCT02025075|BG002|Baseline|Total|Total of all reporting groups
11174827|NCT02025075|FG000|Participant Flow|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
11174828|NCT02025075|FG001|Participant Flow|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
11174829|NCT02025075|OG000|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
11174830|NCT02025075|OG001|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
11174831|NCT02025075|OG002|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
11174832|NCT02025075|OG003|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
11174833|NCT02025075|OG004|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
11174834|NCT02025075|OG005|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
10918398|NCT00653133|BG000|Baseline|USPNB|ultrasound imaging guided peripheral nerve block
10918399|NCT00653133|BG001|Baseline|NSPNB|Stimulator guided nerve block
10918400|NCT00653133|BG002|Baseline|Total|Total of all reporting groups
10918401|NCT00653133|FG000|Participant Flow|USPNB|ultrasound imaging guided peripheral nerve block
10918402|NCT00653133|FG001|Participant Flow|NSPNB|Stimulator guided nerve block
10918403|NCT00653133|OG000|Outcome|USPNB|Ultrasound imaging guided peripheral nerve block
10918404|NCT00653133|OG001|Outcome|NSPNB|Nerve Stimulator guided peripheral nerve block
10918405|NCT00653133|EG000|Reported Event|USPNB|ultrasound imaging guided peripheral nerve block
10918406|NCT00653133|EG001|Reported Event|NSPNB|Stimulator guided nerve block
10918407|NCT00653159|BG000|Baseline|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
10918408|NCT00653159|BG001|Baseline|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
10918409|NCT00653159|BG002|Baseline|Total|Total of all reporting groups
10918410|NCT00653159|FG000|Participant Flow|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
10918411|NCT00653159|FG001|Participant Flow|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
10918412|NCT00653159|OG000|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
10918413|NCT00653159|OG001|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
10918414|NCT00653159|EG000|Reported Event|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
10918415|NCT00653159|EG001|Reported Event|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
10918416|NCT00653224|BG000|Baseline|Placebo|Matching oral placebo tablet daily for 14 days
10918417|NCT00653224|BG001|Baseline|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
10918418|NCT00653224|BG002|Baseline|Total|Total of all reporting groups
10918419|NCT00653224|FG000|Participant Flow|Placebo|Matching oral placebo tablet daily for 14 days
10918420|NCT00653224|FG001|Participant Flow|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
10918421|NCT00653224|OG000|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
10918422|NCT00653224|OG001|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
10918423|NCT00653224|EG000|Reported Event|Placebo|Matching oral placebo tablet daily for 14 days
10918424|NCT00653224|EG001|Reported Event|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
10918425|NCT00653263|BG000|Baseline|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
10918426|NCT00653263|FG000|Participant Flow|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
10918427|NCT00653263|OG000|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
10918428|NCT00653263|EG000|Reported Event|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
10918429|NCT00653328|BG000|Baseline|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
10918430|NCT00653328|FG000|Participant Flow|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
10918431|NCT00653328|OG000|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
10918432|NCT00653328|EG000|Reported Event|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
10918433|NCT00653432|BG000|Baseline|Monovisc®|"Injectable Hyaluronic Acid Gel~Monovisc®: Intra-articular injection"
10918434|NCT00653432|BG001|Baseline|Saline|"0.9% Sterile Saline~Saline: 0.9% Sterile Saline"
10918435|NCT00653432|BG002|Baseline|Total|Total of all reporting groups
10918436|NCT00653432|FG000|Participant Flow|Monovisc®|"Injectable Hyaluronic Acid Gel~Monovisc®: Intra-articular injection"
10918437|NCT00653432|FG001|Participant Flow|Saline|"0.9% Sterile Saline~Saline: 0.9% Sterile Saline"
10918438|NCT00653432|OG000|Outcome|Monovisc®|"Injectable Hyaluronic Acid Gel~Monovisc®: Intra-articular injection"
10918439|NCT00653432|OG001|Outcome|Saline|"0.9% Sterile Saline~Saline: 0.9% Sterile Saline"
10918440|NCT00653432|EG000|Reported Event|Monovisc®|"Injectable Hyaluronic Acid Gel~Monovisc®: Intra-articular injection"
10918441|NCT00653432|EG001|Reported Event|Saline|"0.9% Sterile Saline~Saline: 0.9% Sterile Saline"
10918442|NCT00653861|BG000|Baseline|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
10918443|NCT00653861|FG000|Participant Flow|Total Study Participants|Subjects who received Juvederm with Lidocaine in one nasolabial fold and Juvederm without Lidocaine in the other nasolabial fold
10918444|NCT00653861|OG000|Outcome|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
10918445|NCT00653861|OG001|Outcome|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
10918446|NCT00653861|OG000|Outcome|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
10918447|NCT00653861|OG000|Outcome|Juvéderm Lidocaine NLFs|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
10918448|NCT00653861|OG001|Outcome|Juvéderm NLFs|Nasolabial folds on the corresponding side of the face injected with Juvederm
10918449|NCT00653861|EG000|Reported Event|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
10918450|NCT00653861|EG001|Reported Event|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
10963159|NCT00870584|EG000|Reported Event|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
10918451|NCT00653939|BG000|Baseline|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918452|NCT00653939|BG001|Baseline|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918453|NCT00653939|BG002|Baseline|Total|Total of all reporting groups
10918454|NCT00653939|FG000|Participant Flow|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918455|NCT00653939|FG001|Participant Flow|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918456|NCT00653939|OG000|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918457|NCT00653939|OG001|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918458|NCT00653939|OG000|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918459|NCT00653939|OG001|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918460|NCT00653939|EG000|Reported Event|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10963160|NCT00870584|EG001|Reported Event|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
10963161|NCT00870727|BG000|Baseline|Arm 1. Aripiprazole Oral Product|"Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.~Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment."
10918461|NCT00653939|EG001|Reported Event|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
10918462|NCT00653991|BG000|Baseline|SOLVE-IT|"Participants will receive the intervention SOLVE-IT. The SOLVE-IT intervention is a videogame designed to optimize self-regulation, reduce shame, and reduce risky choices for young men who have sex with men (YMSM).~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918463|NCT00653991|BG001|Baseline|Waitlist Control|"Participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM, after a 6-month waitlist period.~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918464|NCT00653991|BG002|Baseline|Total|Total of all reporting groups
10918465|NCT00653991|FG000|Participant Flow|SOLVE-IT|"Participants will receive the intervention SOLVE-IT. The SOLVE-IT intervention is a videogame designed to optimize self-regulation, reduce shame, and reduce risky choices for young men who have sex with men (YMSM).~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918466|NCT00653991|FG001|Participant Flow|Waitlist Control|"Participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM, after a 6-month waitlist period.~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918467|NCT00653991|OG000|Outcome|SOLVE-IT|"Participants will receive the intervention SOLVE-IT. The SOLVE-IT intervention is a videogame designed to optimize self-regulation, reduce shame, and reduce risky choices for young men who have sex with men (YMSM).~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918468|NCT00653991|OG001|Outcome|Waitlist Control|"After a 3-month waitlist period, participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM.~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918469|NCT00653991|OG001|Outcome|Waitlist Control|"After a 6-month waitlist period, participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM.~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918470|NCT00653991|OG001|Outcome|Waitlist Control|"Participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM, after a 6-month waitlist period.~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918471|NCT00653991|EG000|Reported Event|SOLVE-IT|"Participants will receive the intervention SOLVE-IT. The SOLVE-IT intervention is a videogame designed to optimize self-regulation, reduce shame, and reduce risky choices for young men who have sex with men (YMSM).~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918472|NCT00653991|EG001|Reported Event|Waitlist Control|"Participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM, after a 6-month waitlist period.~SOLVE-IT: SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context."
10918473|NCT00654004|BG000|Baseline|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
10918474|NCT00654004|BG001|Baseline|Controls|Subjects do not have a fatty acid oxidation disorder.
10918475|NCT00654004|BG002|Baseline|Total|Total of all reporting groups
10918476|NCT00654004|FG000|Participant Flow|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
10918477|NCT00654004|FG001|Participant Flow|Controls|Subjects do not have a fatty acid oxidation disorder.
10918478|NCT00654004|OG000|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
10918479|NCT00654004|OG001|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
10918480|NCT00654004|EG000|Reported Event|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
10918481|NCT00654004|EG001|Reported Event|Controls|Subjects do not have a fatty acid oxidation disorder.
10918482|NCT00654030|BG000|Baseline|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
10918483|NCT00654030|FG000|Participant Flow|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
10918484|NCT00654030|OG000|Outcome|1650-G ARM|2 immunizations of 1650-G given 4 weeks apart
10918485|NCT00654030|EG000|Reported Event|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
10918486|NCT00654069|BG000|Baseline|Placebo|2x Placebo Tablets
10918487|NCT00654069|BG001|Baseline|Acurox 5/30|2x oxycodone/niacin 5/30mg tablets
10918488|NCT00654069|BG002|Baseline|Acurox 7.5/30|2x oxycodone/niacin 7.5/30mg tablets
10918489|NCT00654069|BG003|Baseline|Total|Total of all reporting groups
10918490|NCT00654069|FG000|Participant Flow|Placebo|2 Tablets Every 6 Hours
10918491|NCT00654069|FG001|Participant Flow|Acurox 5/30mg|2x oxycodone 5mg/naicin 30mg every 6 hours
10918492|NCT00654069|FG002|Participant Flow|Acurox 7.5/30mg|2x oxycodone 7.5mg/naicin 30mg every 6 hours
10918493|NCT00654069|OG000|Outcome|Placebo|Placebo Tablet
10918494|NCT00654069|OG001|Outcome|Acurox 5/30|oxycodone 5mg/niacin 30mg
10918495|NCT00654069|OG002|Outcome|Acurox 7.5/30|oxycodone 7.5mg/niacin 30mg
10918496|NCT00654069|EG000|Reported Event|Placebo|Placebo Pill
10918497|NCT00654069|EG001|Reported Event|Acurox 5/30|oxycodone 5mg/niacin 30mg
10918498|NCT00654069|EG002|Reported Event|Acurox 7.5/30|oxycodone 7.5mg/niacin 30mg
10918499|NCT00654147|BG000|Baseline|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet every 12 hours for 48 & Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
10918500|NCT00654147|BG001|Baseline|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours for 48 weeks & emtricitabine 200mg/ tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
10918501|NCT00654147|BG002|Baseline|Total|Total of all reporting groups
10918502|NCT00654147|FG000|Participant Flow|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
10918503|NCT00654147|FG001|Participant Flow|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
10918504|NCT00654147|OG000|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
10918505|NCT00654147|OG001|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
10918506|NCT00654147|EG000|Reported Event|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
10918507|NCT00654147|EG001|Reported Event|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
10918508|NCT00654186|BG000|Baseline|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
10918509|NCT00654186|FG000|Participant Flow|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
10918510|NCT00654186|OG000|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
10918511|NCT00654186|EG000|Reported Event|Revlimid Orally for 21 Days|Revlimid: 25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
10918512|NCT00654238|BG000|Baseline|Sorafenib|"This is a single arm study.~sorafenib: 400mg PO BID daily"
10918513|NCT00654238|FG000|Participant Flow|Sorafenib|"This is a single arm study.~sorafenib: 400mg PO BID daily"
10918514|NCT00654238|OG000|Outcome|Sorafenib|"This is a single arm study.~sorafenib: 400mg PO BID daily"
10918515|NCT00654238|OG000|Outcome|Progression Free Survival For Entire Study (55 Total Patients)|This is based on Kaplan Meier estimate
10918516|NCT00654238|EG000|Reported Event|Sorafenib|"This is a single arm study.~sorafenib: 400mg PO BID daily"
10918517|NCT00654329|BG000|Baseline|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
10918518|NCT00654329|BG001|Baseline|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
10918519|NCT00654329|BG002|Baseline|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
10918520|NCT00654329|BG003|Baseline|Normal Saline Placebo|Normal saline placebo intranasal
10918521|NCT00654329|BG004|Baseline|Total|Total of all reporting groups
10918522|NCT00654329|FG000|Participant Flow|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
10918523|NCT00654329|FG001|Participant Flow|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
10918524|NCT00654329|FG002|Participant Flow|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
10918525|NCT00654329|FG003|Participant Flow|Normal Saline Placebo|Normal saline placebo intranasal
10918526|NCT00654329|OG000|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
10918527|NCT00654329|OG001|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
10918528|NCT00654329|OG002|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
10918529|NCT00654329|OG003|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
10918530|NCT00654329|EG000|Reported Event|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
10918531|NCT00654329|EG001|Reported Event|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
10918532|NCT00654329|EG002|Reported Event|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
10918533|NCT00654329|EG003|Reported Event|Normal Saline Placebo|Normal saline placebo intranasal
10918534|NCT00654355|BG000|Baseline|Control Group|Group only had visits at Baseline and Week 4.
10918535|NCT00654355|BG001|Baseline|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
10918536|NCT00654355|BG002|Baseline|Total|Total of all reporting groups
10918537|NCT00654355|FG000|Participant Flow|Control Group|Group only had visits at Baseline and Week 4.
10918538|NCT00654355|FG001|Participant Flow|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
10918539|NCT00654355|OG000|Outcome|Control Group|Group only had visits at Baseline and Week 4.
10918540|NCT00654355|OG001|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
10918541|NCT00654355|EG000|Reported Event|Control Group|Group only had visits at Baseline and Week 4.
10918542|NCT00654355|EG001|Reported Event|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
10918543|NCT00654368|BG000|Baseline|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
10918544|NCT00654368|BG001|Baseline|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
10918545|NCT00654368|BG002|Baseline|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
10918546|NCT00654368|BG003|Baseline|Total|Total of all reporting groups
10918547|NCT00654368|FG000|Participant Flow|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
10918548|NCT00654368|FG001|Participant Flow|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
10918549|NCT00654368|FG002|Participant Flow|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
10918550|NCT00654368|OG000|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
10918551|NCT00654368|OG001|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
10918552|NCT00654368|EG000|Reported Event|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
10918553|NCT00654368|EG001|Reported Event|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
10918554|NCT00654368|EG002|Reported Event|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
10918555|NCT00654381|BG000|Baseline|Placebo|The patients with placebo at the start of randomised study medication
10918556|NCT00654381|BG001|Baseline|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
10918557|NCT00654381|BG002|Baseline|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
10918558|NCT00654381|BG003|Baseline|Voglibose|The patients with voglibose at the start of randomised study medication
10918559|NCT00654381|BG004|Baseline|Total|Total of all reporting groups
10918560|NCT00654381|FG000|Participant Flow|Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg|Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
10918561|NCT00654381|FG001|Participant Flow|Placebo - Linagliptin 5mg - Linagliptin 10mg|Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
10918562|NCT00654381|FG002|Participant Flow|Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg|5 mg in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
10918563|NCT00654381|FG003|Participant Flow|Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg|10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
10918564|NCT00654381|FG004|Participant Flow|Voglibose - Voglibose - Linagliptin 5mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3
10918565|NCT00654381|FG005|Participant Flow|Voglibose - Voglibose - Linagliptin 10mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
10918566|NCT00654381|OG000|Outcome|Placebo|The patients with placebo at the start of randomised study medication
10918567|NCT00654381|OG001|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
10918568|NCT00654381|OG002|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
10918569|NCT00654381|OG000|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
10918570|NCT00654381|OG001|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
10918571|NCT00654381|OG002|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
10918572|NCT00654381|OG001|Outcome|Linagliptin 10mg|The patients with linagliptin 10 mg at the start of randomised study medication
10918573|NCT00654381|EG000|Reported Event|Placebo (1st Stage)|
10918574|NCT00654381|EG001|Reported Event|Linagliptin 5mg (2nd-Extension Stage After Placebo)|
10918575|NCT00654381|EG002|Reported Event|Linagliptin 10mg (2nd-Extension Stage After Placebo)|
10918576|NCT00654381|EG003|Reported Event|Linagliptin 5mg (1st-2nd-Extension Stage)|
11174835|NCT02025075|OG000|Outcome|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
10918577|NCT00654381|EG004|Reported Event|Linagliptin 10mg (1st-2nd-Extension Stage)|
10918578|NCT00654381|EG005|Reported Event|Voglibose (1st-2nd Stage)|
10918579|NCT00654381|EG006|Reported Event|Linagliptin 5mg (Extension Stage After Voglibose)|
10918580|NCT00654381|EG007|Reported Event|Linagliptin 10mg (Extension Stage After Voglibose)|
10918581|NCT00654420|BG000|Baseline|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
10918582|NCT00654420|BG001|Baseline|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
10918583|NCT00654420|BG002|Baseline|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
10918584|NCT00654420|BG003|Baseline|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
10918585|NCT00654420|BG004|Baseline|Total|Total of all reporting groups
10918586|NCT00654420|FG000|Participant Flow|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab intravenously (IV) at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
10918587|NCT00654420|FG001|Participant Flow|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
10918588|NCT00654420|FG002|Participant Flow|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
10918589|NCT00654420|FG003|Participant Flow|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
10918590|NCT00654420|OG000|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
10918591|NCT00654420|OG001|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
10918592|NCT00654420|OG002|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
10918593|NCT00654420|OG003|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
10918594|NCT00654420|EG000|Reported Event|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
10918595|NCT00654420|EG001|Reported Event|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
10918596|NCT00654420|EG002|Reported Event|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
10918597|NCT00654420|EG003|Reported Event|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
10918598|NCT00654498|BG000|Baseline|Pramipexole|
10918599|NCT00654498|BG001|Baseline|Placebo|
10918600|NCT00654498|BG002|Baseline|Total|Total of all reporting groups
10918601|NCT00654498|FG000|Participant Flow|Pramipexole|4 weeks of individual dose titration starting with 0.125 mg pramipexole, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily
10918602|NCT00654498|FG001|Participant Flow|Placebo|1 tablet (Pramipexole 0.125 mg matching placebo tablet), or 1 or 2 or 3 tablets (Pramipexole 0.25 mg matching placebo tablet), once daily
10918603|NCT00654498|OG000|Outcome|Pramipexole|
10918604|NCT00654498|OG001|Outcome|Placebo|
10918605|NCT00654498|EG000|Reported Event|Pramipexole|
10918606|NCT00654498|EG001|Reported Event|Placebo|
10918607|NCT00654511|BG000|Baseline|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
10918608|NCT00654511|BG001|Baseline|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
10918609|NCT00654511|BG002|Baseline|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
10918610|NCT00654511|BG003|Baseline|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
10918611|NCT00654511|BG004|Baseline|Total|Total of all reporting groups
10918612|NCT00654511|FG000|Participant Flow|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
10918613|NCT00654511|FG001|Participant Flow|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
10918614|NCT00654511|FG002|Participant Flow|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
10918615|NCT00654511|FG003|Participant Flow|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
10918616|NCT00654511|OG000|Outcome|Fentanyl 1 Microgram/Kilogram IV|
10918617|NCT00654511|OG001|Outcome|Fentanyl 2 Micrograms/Kilogram IV|
10918618|NCT00654511|OG002|Outcome|Dexmedetomidine 2 Microgram/Kilogram IV|
10918619|NCT00654511|OG003|Outcome|Dexmedetomidine 4 Micrograms/Kilogram IV|
10918620|NCT00654511|OG000|Outcome|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
10918621|NCT00654511|OG001|Outcome|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
10918622|NCT00654511|OG002|Outcome|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
10918623|NCT00654511|OG003|Outcome|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
10918624|NCT00654511|EG000|Reported Event|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
10918625|NCT00654511|EG001|Reported Event|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
10918626|NCT00654511|EG002|Reported Event|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
10918627|NCT00654511|EG003|Reported Event|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
10918628|NCT00654615|BG000|Baseline|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
10963162|NCT00870727|BG001|Baseline|Arm 2. Placebo Oral Capsule|"Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.~Placebo oral capsule: Placebo will identical in size and appearance to study drug."
10963163|NCT00870727|BG002|Baseline|Total|Total of all reporting groups
10963164|NCT00870727|FG000|Participant Flow|Arm 1. Aripiprazole Oral Product|"Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.~Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment."
10918629|NCT00654615|BG001|Baseline|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
10918630|NCT00654615|BG002|Baseline|Total|Total of all reporting groups
10918631|NCT00654615|FG000|Participant Flow|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
10918632|NCT00654615|FG001|Participant Flow|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
10918633|NCT00654615|OG000|Outcome|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
10918634|NCT00654615|OG001|Outcome|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
10918635|NCT00654615|EG000|Reported Event|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
10963165|NCT00870727|FG001|Participant Flow|Arm 2. Placebo Oral Capsule|"Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.~Placebo oral capsule: Placebo will identical in size and appearance to study drug."
10963166|NCT00870727|OG000|Outcome|Arm 1. Aripiprazole Oral Product|"Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.~Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment."
11234035|NCT02431806|OG002|Outcome|Levomilnacipran 80 mg/Day|Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
10918636|NCT00654615|EG001|Reported Event|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
10918637|NCT00654641|BG000|Baseline|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
10918638|NCT00654641|BG001|Baseline|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
10918639|NCT00654641|BG002|Baseline|Total|Total of all reporting groups
10918640|NCT00654641|FG000|Participant Flow|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
10918641|NCT00654641|FG001|Participant Flow|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
10918642|NCT00654641|OG000|Outcome|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
10918643|NCT00654641|OG001|Outcome|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
10918644|NCT00654641|EG000|Reported Event|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
10918645|NCT00654641|EG001|Reported Event|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
10918646|NCT00654654|BG000|Baseline|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
10918647|NCT00654654|FG000|Participant Flow|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
10918648|NCT00654654|OG000|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
10918649|NCT00654654|EG000|Reported Event|Active|Patients treated with autologous human fibroblasts
10918650|NCT00654732|BG000|Baseline|RABVD|Rituximab Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine
10918651|NCT00654732|BG001|Baseline|ABVD|Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine
10918652|NCT00654732|BG002|Baseline|Total|Total of all reporting groups
10918653|NCT00654732|FG000|Participant Flow|RABVD|Rituximab Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine
10918654|NCT00654732|FG001|Participant Flow|ABVD|Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine
10918655|NCT00654732|OG000|Outcome|RABVD|Experimental Arm Rituximab, Adriamycin, Bleomycin, Vinblastine, and Dacarbazine
10918656|NCT00654732|OG001|Outcome|ABVD|Control Arm (Adriamycin, Bleomycin, Vinblastine, and Dacarbazine)
10918657|NCT00654732|EG000|Reported Event|RABVD|Rituximab chemotherapy
10918658|NCT00654732|EG001|Reported Event|ABVD|Chemotherapy only
10918659|NCT00654745|BG000|Baseline|Aml + Olm + Hctz|amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.
10918660|NCT00654745|FG000|Participant Flow|Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide|Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
10918661|NCT00654745|OG000|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
10918662|NCT00654745|EG000|Reported Event|ALL - Aml + Olm + Hctz|Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
10918663|NCT00654745|EG001|Reported Event|Start - Amlodipine 5 mg|All participants started trial on Amlodipine 5 mg.
10918664|NCT00654745|EG002|Reported Event|Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
10918665|NCT00654745|EG003|Reported Event|Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
10918666|NCT00654745|EG004|Reported Event|Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
10918667|NCT00654745|EG005|Reported Event|Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
10918668|NCT00654745|EG006|Reported Event|Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
10918669|NCT00654784|BG000|Baseline|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
10918670|NCT00654784|BG001|Baseline|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
10918671|NCT00654784|BG002|Baseline|Total|Total of all reporting groups
10918672|NCT00654784|FG000|Participant Flow|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
10918673|NCT00654784|FG001|Participant Flow|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
10918674|NCT00654784|OG000|Outcome|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
11174836|NCT02025075|OG001|Outcome|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
11174837|NCT02025075|EG000|Reported Event|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
11174838|NCT02025075|EG001|Reported Event|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
11174839|NCT02025179|BG000|Baseline|Teriparatide|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
11174840|NCT02025179|BG001|Baseline|Vibration|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
11174841|NCT02025179|BG002|Baseline|Teriparatide and Vibration|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Teriparatide with vibration applied in conjunction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
11174842|NCT02025179|BG003|Baseline|Total|Total of all reporting groups
11174843|NCT02025179|FG000|Participant Flow|Teriparatide|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
11174844|NCT02025179|FG001|Participant Flow|Vibration|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
11174845|NCT02025179|FG002|Participant Flow|Teriparatide and Vibration|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Teriparatide with vibration applied in conjunction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
11174846|NCT02025179|OG000|Outcome|Teriparatide|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
11174847|NCT02025179|OG001|Outcome|Vibration|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
11174848|NCT02025179|OG002|Outcome|Teriparatide and Vibration|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Teriparatide with vibration applied in conjunction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
11174849|NCT02025179|EG000|Reported Event|Teriparatide|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
11174850|NCT02025179|EG001|Reported Event|Vibration|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
11174851|NCT02025179|EG002|Reported Event|Teriparatide and Vibration|"Experimental: Teriparatide and vibration~Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months~Device: Vibration 10 min/day for 12 months~Completed in previously enrolled study (STU00033380),~Teriparatide with vibration applied in conjunction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
11174852|NCT02025205|BG000|Baseline|ELVR With Endobronchial Valves|"Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve~Endobronchial Valve: Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve"
11174853|NCT02025205|BG001|Baseline|Standard of Care|Patients will receive optimal drug therapy and medical management according to clinical practice.
11174854|NCT02025205|BG002|Baseline|Total|Total of all reporting groups
11174855|NCT02025205|FG000|Participant Flow|BLVR With Zephyr Endobronchial Valves|"Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves~Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve"
11174856|NCT02025205|FG001|Participant Flow|Standard of Care|Patients will receive optimal drug therapy and medical management according to clinical practice.
11174857|NCT02025205|OG000|Outcome|BLVR With Zephyr Endobronchial Valves|"Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves~Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve"
11174858|NCT02025205|OG001|Outcome|Standard of Care|Patients will receive optimal drug therapy and medical management according to clinical practice.
11174859|NCT02025205|EG000|Reported Event|BLVR With Zephyr Endobronchial Valves|"Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves~Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve"
10918675|NCT00654784|OG001|Outcome|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
10918676|NCT00654784|EG000|Reported Event|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
10918677|NCT00654784|EG001|Reported Event|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
10918678|NCT00654836|BG000|Baseline|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
10918679|NCT00654836|FG000|Participant Flow|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
10918680|NCT00654836|OG000|Outcome|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
10918681|NCT00654836|EG000|Reported Event|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
10918682|NCT00654875|BG000|Baseline|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
10918683|NCT00654875|BG001|Baseline|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
10918684|NCT00654875|BG002|Baseline|Total|Total of all reporting groups
10918685|NCT00654875|FG000|Participant Flow|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
10918686|NCT00654875|FG001|Participant Flow|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
10918687|NCT00654875|OG000|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
10918688|NCT00654875|OG001|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
10918689|NCT00654875|EG000|Reported Event|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
11174860|NCT02025205|EG001|Reported Event|Standard of Care|Patients will receive optimal drug therapy and medical management according to clinical practice.
11174861|NCT02025426|BG000|Baseline|Phenylephrine|"Phenylephrine for maintaining blood pressure within 10 % of baseline~Phenylephrine"
11174862|NCT02025426|BG001|Baseline|Ephedrine|"Ephedrine for maintaining blood pressure within 10 % of baseline~Ephedrine"
11174863|NCT02025426|BG002|Baseline|Total|Total of all reporting groups
11174864|NCT02025426|FG000|Participant Flow|Phenylephrine|"Phenylephrine for maintaining blood pressure within 10 % of baseline~Phenylephrine"
11174865|NCT02025426|FG001|Participant Flow|Ephedrine|"Ephedrine for maintaining blood pressure within 10 % of baseline~Ephedrine"
11174866|NCT02025426|OG000|Outcome|Phenylephrine|"Phenylephrine for maintaining blood pressure within 10 % of baseline~Phenylephrine"
10918690|NCT00654875|EG001|Reported Event|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
10918691|NCT00654901|BG000|Baseline|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918692|NCT00654901|BG001|Baseline|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918693|NCT00654901|BG002|Baseline|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918694|NCT00654901|BG003|Baseline|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
11174867|NCT02025426|OG001|Outcome|Ephedrine|"Ephedrine for maintaining blood pressure within 10 % of baseline~Ephedrine"
11174868|NCT02025426|EG000|Reported Event|Phenylephrine|"Phenylephrine for maintaining blood pressure within 10 % of baseline~Phenylephrine"
11174869|NCT02025426|EG001|Reported Event|Ephedrine|"Ephedrine for maintaining blood pressure within 10 % of baseline~Ephedrine"
11174870|NCT02025439|BG000|Baseline|rTMS First|"Subjects assigned to rTMS Alone will receive 30 sessions of rTMS. Two rTMS sessions will be provided per day, four days per week.~rTMS"
11174871|NCT02025439|BG001|Baseline|Amantadine First|"Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days.~Amantadine"
10918695|NCT00654901|BG004|Baseline|Total|Total of all reporting groups
11174872|NCT02025439|BG002|Baseline|Total|Total of all reporting groups
11174873|NCT02025439|FG000|Participant Flow|rTMS Alone Followed by rTMS+AMA|"Subjects assigned to rTMS Alone will receive 30 sessions of rTMS. Two rTMS sessions will be provided per day, four days per week.upon completion of assigned treatment order, the subject will then receive 30 sessions of combination therapy of rTMS + Amantadine~rTMS"
11174874|NCT02025439|FG001|Participant Flow|AMA Alone Followed by rTMS+AMA|"Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days. upon completion of assigned treatment order, the subject will then receive 30 sessions of combination therapy of rTMS + Amantadine~Amantadine"
11174875|NCT02025439|OG000|Outcome|rTMS Alone|Subjects assigned to start with rTMS Alone
11174876|NCT02025439|OG001|Outcome|rTMS+AMA|All subjects that received rTMS plus Amantadine. A total of 30 rTMS sessions are provided, 2 rTMS sessions per day, four days per week, while receiving 200mg of Amantadine daily.
11174877|NCT02025439|OG002|Outcome|AMA Alone|Subjects assigned to start with amantadine alone
11174878|NCT02025439|EG000|Reported Event|rTMS Alone|Subjects assigned to rTMS Alone 30 sessions of rTMS. Two rTMS sessions will be provided per day, four days per week.
11174879|NCT02025439|EG001|Reported Event|rTMS+AMA|Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days.Then, A total of 30 rTMS sessions are provided, 2 rTMS sessions per day, four days per week, while receiving 200mg of Amantadine daily.
11174880|NCT02025439|EG002|Reported Event|AMA Alone|Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days.
11174881|NCT02025530|BG000|Baseline|Cases (Stillbirth)|"A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality.~Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls.~Clinical information was obtained from maternal case notes following the interview."
10918696|NCT00654901|FG000|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
11174882|NCT02025530|BG001|Baseline|Controls (Live Pregnancy)|"A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality.~Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls.~Clinical information was obtained from maternal case notes following the interview."
11174883|NCT02025530|BG002|Baseline|Total|Total of all reporting groups
10918697|NCT00654901|FG001|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918698|NCT00654901|FG002|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918699|NCT00654901|FG003|Participant Flow|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
10918700|NCT00654901|OG000|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918701|NCT00654901|OG001|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918702|NCT00654901|OG002|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918703|NCT00654901|OG003|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
10918704|NCT00654901|EG000|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918705|NCT00654901|EG001|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918706|NCT00654901|EG002|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
10918707|NCT00654901|EG003|Reported Event|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
10918708|NCT00654927|BG000|Baseline|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
10918709|NCT00654927|FG000|Participant Flow|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
10918710|NCT00654927|OG000|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
10918711|NCT00654927|EG000|Reported Event|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
10918712|NCT00654940|BG000|Baseline|Pregabalin Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
10918713|NCT00654940|BG001|Baseline|Placebo Then Pregabalin|Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
10918714|NCT00654940|BG002|Baseline|Total|Total of all reporting groups
10918715|NCT00654940|FG000|Participant Flow|Pregabalin First Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
10918716|NCT00654940|FG001|Participant Flow|Placebo First Then Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14.
10918717|NCT00654940|OG000|Outcome|Period 1: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
10918718|NCT00654940|OG001|Outcome|Period 1: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
10918719|NCT00654940|OG002|Outcome|Period 2: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
10918720|NCT00654940|OG003|Outcome|Period 2: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
10918721|NCT00654940|OG000|Outcome|Pregabalin/Placebo|Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
10918722|NCT00654940|OG001|Outcome|Placebo/Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
10918723|NCT00654940|OG000|Outcome|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
10918724|NCT00654940|OG001|Outcome|Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
10918725|NCT00654940|EG000|Reported Event|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
10918726|NCT00654940|EG001|Reported Event|Placebo|Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
10963167|NCT00870727|OG001|Outcome|Arm 2. Placebo Oral Capsule|"Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.~Placebo oral capsule: Placebo will be identical in size and appearance to study drug."
10963168|NCT00870727|EG000|Reported Event|Arm 1. Aripiprazole Oral Product|"Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.~Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment."
10963169|NCT00870727|EG001|Reported Event|Arm 2. Placebo Oral Capsule|"Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.~Placebo oral capsule: Placebo will identical in size and appearance to study drug."
10963170|NCT00870740|BG000|Baseline|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
10963171|NCT00870740|BG001|Baseline|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
10963172|NCT00870740|BG002|Baseline|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
10963173|NCT00870740|BG003|Baseline|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
10963174|NCT00870740|BG004|Baseline|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
10963175|NCT00870740|BG005|Baseline|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
10963176|NCT00870740|BG006|Baseline|Total|Total of all reporting groups
10963177|NCT00870740|FG000|Participant Flow|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
10963178|NCT00870740|FG001|Participant Flow|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
10963179|NCT00870740|FG002|Participant Flow|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
10963180|NCT00870740|FG003|Participant Flow|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
10963181|NCT00870740|FG004|Participant Flow|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
10963182|NCT00870740|FG005|Participant Flow|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
10963183|NCT00870740|OG000|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
10963184|NCT00870740|OG001|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
10963185|NCT00870740|OG002|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
10963186|NCT00870740|OG003|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
10918727|NCT00654953|BG000|Baseline|Placebo Group|Placebo capsules
11174884|NCT02025530|FG000|Participant Flow|Cases|"A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality.~Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls.~Clinical information was obtained from maternal case notes following the interview."
11174885|NCT02025530|FG001|Participant Flow|Controls|"A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality.~Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls.~Clinical information was obtained from maternal case notes following the interview."
11174886|NCT02025530|OG000|Outcome|Cases (Stillbirth)|"A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality.~Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls.~Clinical information was obtained from maternal case notes following the interview."
11174887|NCT02025530|OG001|Outcome|Controls (Live Pregnancy)|"A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality.~Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls.~Clinical information was obtained from maternal case notes following the interview."
11174888|NCT02025530|EG000|Reported Event|Cases (Stillbirth)|"A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality.~Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls.~Clinical information was obtained from maternal case notes following the interview."
11174889|NCT02025530|EG001|Reported Event|Controls (Live Pregnancy)|"A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality.~Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls.~Clinical information was obtained from maternal case notes following the interview."
11174890|NCT02025621|BG000|Baseline|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
11174891|NCT02025621|BG001|Baseline|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
11174892|NCT02025621|BG002|Baseline|Total|Total of all reporting groups
11174893|NCT02025621|FG000|Participant Flow|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
11174894|NCT02025621|FG001|Participant Flow|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
10918728|NCT00654953|BG001|Baseline|Active Group: Sertraline Alone|sertraline (200 mg/day)
11174895|NCT02025621|OG000|Outcome|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
11174896|NCT02025621|OG001|Outcome|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
11174897|NCT02025621|EG000|Reported Event|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
10918729|NCT00654953|BG002|Baseline|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
10918730|NCT00654953|BG003|Baseline|Total|Total of all reporting groups
11174898|NCT02025621|EG001|Reported Event|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
11174899|NCT02025634|BG000|Baseline|Intravenous Acetaminophen|"Infusion of Intravenous acetaminophen (Ofirmev)~Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."
11174900|NCT02025634|BG001|Baseline|Placebo (0.9% Normal Saline Infusion)|"Infusion of 100 ml of 0.9 NS Normal Saline~Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS"
11174901|NCT02025634|BG002|Baseline|Total|Total of all reporting groups
11174902|NCT02025634|FG000|Participant Flow|Intravenous Acetaminophen|"Infusion of Intravenous acetaminophen (Ofirmev)~Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."
11174903|NCT02025634|FG001|Participant Flow|Placebo (0.9% Normal Saline Infusion)|"Infusion of 100 ml of 0.9 NS Normal Saline~Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS"
11174904|NCT02025634|OG000|Outcome|Intravenous Acetaminophen|"Infusion of Intravenous acetaminophen (Ofirmev)~Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."
11174905|NCT02025634|OG001|Outcome|Placebo (0.9% Normal Saline Infusion)|"Infusion of 100 ml of 0.9 NS Normal Saline~Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS"
10918731|NCT00654953|FG000|Participant Flow|Placebo Group|Placebo capsules
10918732|NCT00654953|FG001|Participant Flow|Active Group: Sertraline Alone|sertraline (200 mg/day)
10918733|NCT00654953|FG002|Participant Flow|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
10918734|NCT00654953|OG000|Outcome|Placebo|
11174906|NCT02025634|EG000|Reported Event|Intravenous Acetaminophen|"Infusion of Intravenous acetaminophen (Ofirmev)~Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."
11174907|NCT02025634|EG001|Reported Event|Placebo (0.9% Normal Saline Infusion)|"Infusion of 100 ml of 0.9 NS Normal Saline~Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS"
11174908|NCT02025647|BG000|Baseline|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
11174909|NCT02025647|FG000|Participant Flow|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
11174910|NCT02025647|OG000|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
11174911|NCT02025647|EG000|Reported Event|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
11174912|NCT02025725|BG000|Baseline|10 mg Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks~Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide"
11174913|NCT02025725|BG001|Baseline|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks~Placebo Nasal Spray: nasal spray formulation with vehicle only"
11174914|NCT02025725|BG002|Baseline|Total|Total of all reporting groups
11174915|NCT02025725|FG000|Participant Flow|10 mg Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks~Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide"
11174916|NCT02025725|FG001|Participant Flow|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks~Placebo Nasal Spray: nasal spray formulation with vehicle only"
11174917|NCT02025725|OG000|Outcome|10 mg Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime for 4 weeks~Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide"
11174918|NCT02025725|OG001|Outcome|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime for 4 weeks~Placebo Nasal Spray: nasal spray formulation with vehicle only"
11174919|NCT02025725|OG000|Outcome|10 mg Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks~Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide"
11174920|NCT02025725|OG001|Outcome|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks~Placebo Nasal Spray: nasal spray formulation with vehicle only"
11174921|NCT02025725|EG000|Reported Event|10 mg Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime for 4 weeks~Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide"
11174922|NCT02025725|EG001|Reported Event|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime for 4 weeks~Placebo Nasal Spray: nasal spray formulation with vehicle only"
11174923|NCT02025751|BG000|Baseline|Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks~Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)"
11174924|NCT02025751|BG001|Baseline|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks~Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)"
11174925|NCT02025751|BG002|Baseline|Total|Total of all reporting groups
11174926|NCT02025751|FG000|Participant Flow|Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks~Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)"
11174927|NCT02025751|FG001|Participant Flow|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks~Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)"
11174928|NCT02025751|OG000|Outcome|Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks~Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)"
11174929|NCT02025751|OG001|Outcome|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks~Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)"
11174930|NCT02025751|EG000|Reported Event|Metoclopramide Nasal Spray|"Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks~Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)"
10918735|NCT00654953|OG001|Outcome|Sertraline|
11174931|NCT02025751|EG001|Reported Event|Placebo Nasal Spray|"Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks~Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)"
11174932|NCT02025829|BG000|Baseline|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
11174933|NCT02025829|BG001|Baseline|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
11174934|NCT02025829|BG002|Baseline|Total|Total of all reporting groups
11174935|NCT02025829|FG000|Participant Flow|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
11174936|NCT02025829|FG001|Participant Flow|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
11174937|NCT02025829|OG000|Outcome|Begining of Exacerbation|Study volunteer at the beginning of IV antibiotic treatment for a pulmonary exacerbation
11174938|NCT02025829|OG001|Outcome|End of Exacerbation|Study volunteer at the completion of 2 weeks IV antibiotic treatment for a pulmonary exacerbation
11174939|NCT02025829|OG000|Outcome|Clinically Stable Cohort|Clinically stable subjects
11174940|NCT02025829|EG000|Reported Event|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
11174941|NCT02025829|EG001|Reported Event|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
11174942|NCT02025907|BG000|Baseline|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
11174943|NCT02025907|BG001|Baseline|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
11174944|NCT02025907|BG002|Baseline|Total|Total of all reporting groups
11174945|NCT02025907|FG000|Participant Flow|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
11174946|NCT02025907|FG001|Participant Flow|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
11174947|NCT02025907|OG000|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
11174948|NCT02025907|OG001|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
11174949|NCT02025907|EG000|Reported Event|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
11174950|NCT02025907|EG001|Reported Event|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
11174951|NCT02025985|BG000|Baseline|Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174952|NCT02025985|BG001|Baseline|Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174953|NCT02025985|BG002|Baseline|Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174954|NCT02025985|BG003|Baseline|Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174955|NCT02025985|BG004|Baseline|Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174956|NCT02025985|BG005|Baseline|Total|Total of all reporting groups
11174957|NCT02025985|FG000|Participant Flow|Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 milligram per meter square (mg/m^2) of selinexor oral tablets twice weekly (BIW) (doses at least 36 hours apart) with light meal and 120 milliliters (mL) of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 once weekly (QW). This treatment continued until progression of disease (PD) or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174958|NCT02025985|FG001|Participant Flow|Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
10918736|NCT00654953|OG002|Outcome|Sertraline Plus Gabapentin|
10918737|NCT00654953|EG000|Reported Event|Placebo Group|Placebo capsules
10918738|NCT00654953|EG001|Reported Event|Active Group: Sertraline Alone|sertraline (200 mg/day)
10918739|NCT00654953|EG002|Reported Event|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
10918740|NCT00655083|BG000|Baseline|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
10918741|NCT00655083|BG001|Baseline|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
10918742|NCT00655083|BG002|Baseline|Total|Total of all reporting groups
10918743|NCT00655083|FG000|Participant Flow|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
10918744|NCT00655083|FG001|Participant Flow|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
10918745|NCT00655083|OG000|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
10918746|NCT00655083|OG001|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
10918747|NCT00655083|EG000|Reported Event|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
10918748|NCT00655083|EG001|Reported Event|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
10918749|NCT00655356|BG000|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
10918750|NCT00655356|BG001|Baseline|Placebo|Patients treated with placebo solution
10918751|NCT00655356|BG002|Baseline|Total|Total of all reporting groups
10918752|NCT00655356|FG000|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
10918753|NCT00655356|FG001|Participant Flow|Placebo|Patients treated with placebo solution
10918754|NCT00655356|OG000|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
10918755|NCT00655356|OG001|Outcome|Placebo|Patients treated with placebo solution.
10918756|NCT00655356|EG000|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
10918757|NCT00655356|EG001|Reported Event|Placebo|Patients treated with placebo solution.
10918758|NCT00655473|BG000|Baseline|Dalcetrapib (RO4607381)|Dalcetrapib (RO4607381): 600mg po daily for 24 months
10918759|NCT00655473|BG001|Baseline|Placebo|Placebo: po daily for 24 months
10918760|NCT00655473|BG002|Baseline|Total|Total of all reporting groups
10918761|NCT00655473|FG000|Participant Flow|Dalcetrapib (RO4607381)|Dalcetrapib (RO4607381): 600mg po daily for 24 months
10918762|NCT00655473|FG001|Participant Flow|Placebo|Placebo: po daily for 24 months
10918763|NCT00655473|OG000|Outcome|Dalcetrapib (RO4607381)|Dalcetrapib (RO4607381): 600mg po daily for 24 months
10918764|NCT00655473|OG001|Outcome|Placebo|Placebo: po daily for 24 months
10918765|NCT00655473|EG000|Reported Event|Dalcetrapib (RO4607381)|Dalcetrapib (RO4607381): 600mg po daily for 24 months
10918766|NCT00655473|EG001|Reported Event|Placebo|Placebo: po daily for 24 months
10918767|NCT00655486|BG000|Baseline|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
10918768|NCT00655486|FG000|Participant Flow|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
10918769|NCT00655486|OG000|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
10918770|NCT00655486|EG000|Reported Event|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
10918771|NCT00655499|BG000|Baseline|Panitumumab Combined With Irinotecan|1cycle every 14 days (J1=J15). Panitumumab : 6mg/kg in IV infusion over 60 minutes on day 1. Irinotecan : 180mg/m² in IV infusion over 90 minutes on day 1 just after panitumumab administration
10918772|NCT00655499|FG000|Participant Flow|Panitumumab Combined With Irinotecan|65 patients were eligible (69 patients were enrolled and 4 patients were not eligible).
10918773|NCT00655499|OG000|Outcome|Panitumumab Combined With Irinotecan|69 patients were enrolled in the study. 4 patients were not eligible. 65 eligible patients were analysed
10918774|NCT00655499|OG000|Outcome|Panitumumab Combined With Irinotecan|1cycle every 14 days (J1=J15). Panitumumab : 6mg/kg in IV infusion over 60 minutes on day 1. Irinotecan : 180mg/m² in IV infusion over 90 minutes on day 1 just after panitumumab administration
10918775|NCT00655499|EG000|Reported Event|Panitumumab + CPT11|"1 cycle every 14 days (J1= J15)~panitumumab: Panitumumab : 6mg/kg~irinotecan hydrochloride: 180mg/kg~chromogenic in situ hybridization~fluorescence in situ hybridization~gene expression analysis~laboratory biomarker analysis"
10918776|NCT00655538|BG000|Baseline|Dalcetrapib|dalcetrapib: 600mg po daily for 36 weeks
10918777|NCT00655538|BG001|Baseline|Placebo|Placebo: po daily for 36 weeks
10918778|NCT00655538|BG002|Baseline|Total|Total of all reporting groups
10918779|NCT00655538|FG000|Participant Flow|Dalcetrapib|dalcetrapib: 600mg po daily for 36 weeks
10918780|NCT00655538|FG001|Participant Flow|Placebo|Placebo: po daily for 36 weeks
10918781|NCT00655538|OG000|Outcome|Dalcetrapib|dalcetrapib: 600mg po daily for 36 weeks
10918782|NCT00655538|OG001|Outcome|Placebo|Placebo: po daily for 36 weeks
10918783|NCT00655538|EG000|Reported Event|Dalcetrapib|dalcetrapib: 600mg po daily for 36 weeks
10918784|NCT00655538|EG001|Reported Event|Placebo|Placebo: po daily for 36 weeks
10918785|NCT00655551|BG000|Baseline|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
10918786|NCT00655551|BG001|Baseline|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
10918787|NCT00655551|BG002|Baseline|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
10918788|NCT00655551|BG003|Baseline|Total|Total of all reporting groups
10918789|NCT00655551|FG000|Participant Flow|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
10918790|NCT00655551|FG001|Participant Flow|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
10918791|NCT00655551|FG002|Participant Flow|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
10918792|NCT00655551|OG000|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
10918793|NCT00655551|OG001|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
10918794|NCT00655551|OG002|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
10918795|NCT00655551|EG000|Reported Event|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
10918796|NCT00655551|EG001|Reported Event|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
10918797|NCT00655551|EG002|Reported Event|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
10918798|NCT00655564|BG000|Baseline|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
10918799|NCT00655564|FG000|Participant Flow|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
10918800|NCT00655564|OG000|Outcome|Alefacept|Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
10918801|NCT00655564|OG000|Outcome|Alefacept|All subjects received alefacept injections per FDA dosing guidelines for the duration of the 52 weeks study
10918802|NCT00655564|EG000|Reported Event|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
10918803|NCT00655629|BG000|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10918804|NCT00655629|BG001|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10918805|NCT00655629|BG002|Baseline|Total|Total of all reporting groups
10918806|NCT00655629|FG000|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
11234036|NCT02431806|OG003|Outcome|Fluoxetine 20 mg/Day|Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
10918807|NCT00655629|FG001|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10918808|NCT00655629|OG000|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10918809|NCT00655629|OG001|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10918810|NCT00655629|EG000|Reported Event|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10918811|NCT00655629|EG001|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
10918812|NCT00655642|BG000|Baseline|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
10918813|NCT00655642|BG001|Baseline|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
10918814|NCT00655642|BG002|Baseline|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
10918815|NCT00655642|BG003|Baseline|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
10918816|NCT00655642|BG004|Baseline|Total|Total of all reporting groups
10918817|NCT00655642|FG000|Participant Flow|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
10918818|NCT00655642|FG001|Participant Flow|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
10918819|NCT00655642|FG002|Participant Flow|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
10918820|NCT00655642|FG003|Participant Flow|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
10918821|NCT00655642|OG000|Outcome|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
10918822|NCT00655642|OG001|Outcome|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
10918823|NCT00655642|OG002|Outcome|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
10918824|NCT00655642|OG003|Outcome|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
10918825|NCT00655642|EG000|Reported Event|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
10918826|NCT00655642|EG001|Reported Event|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
10918827|NCT00655642|EG002|Reported Event|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
10918828|NCT00655642|EG003|Reported Event|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
10918829|NCT00655668|BG000|Baseline|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
10918830|NCT00655668|FG000|Participant Flow|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
10918831|NCT00655668|OG000|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
10918832|NCT00655668|EG000|Reported Event|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
10918833|NCT00655707|BG000|Baseline|Autologous CD34+ Cells|Patients enrolled in the study underwent 5 days of treatment with G-CSF to mobilise CD34+ cells, followed by leukapheresis to obtain CD34+ cells.
10918834|NCT00655707|FG000|Participant Flow|Treatment|"Autologous CD34+ cells~Autologous Expanded CD34+ Haemopoietic cells: Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein."
10918835|NCT00655707|OG000|Outcome|Autologous CD34+ Cells|Autologous Expanded CD34+ Haemopoietic cells: Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
10918836|NCT00655707|OG000|Outcome|Treatment|"Autologous CD34+ cells~Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein."
10918837|NCT00655707|EG000|Reported Event|Autologous CD34+ Cells|Autologous Expanded CD34+ Haemopoietic cells: Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
10918838|NCT00655733|BG000|Baseline|HMPL-004|Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.
10918839|NCT00655733|BG001|Baseline|Placebo|Subjects who fulfilled all entry criteria and randomized Placebo arm will receive matching placebo 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.
10918840|NCT00655733|BG002|Baseline|Total|Total of all reporting groups
10918841|NCT00655733|FG000|Participant Flow|HMPL-004|Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.
10918842|NCT00655733|FG001|Participant Flow|Placebo|Subjects who fulfilled all entry criteria and randomized Placebo arm will receive matching placebo 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.
10918843|NCT00655733|OG000|Outcome|HMPL-004|Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.
10918844|NCT00655733|OG001|Outcome|Placebo|Subjects who fulfilled all entry criteria and randomized Placebo arm will receive matching placebo 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.
10918845|NCT00655733|OG000|Outcome|HMPL-004|"Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.~HMPL-004: HMPL-004 1200 mg/d"
10918846|NCT00655733|OG001|Outcome|Placebo|"Subjects who fulfilled all entry criteria and randomized Placebo arm will receive matching placebo 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.~Placebo: Placebo 1200 mg/d"
10918847|NCT00655733|EG000|Reported Event|HMPL-004|Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.
10918848|NCT00655733|EG001|Reported Event|Placebo|Subjects who fulfilled all entry criteria and randomized Placebo arm will receive matching placebo 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.
10918849|NCT00655746|BG000|Baseline|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
10918850|NCT00655746|FG000|Participant Flow|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
10918851|NCT00655746|OG000|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
10918852|NCT00655746|OG001|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
10918853|NCT00655746|OG001|Outcome|Omeprazole (Days 2-5)|40-mg oral omeprazole
10918854|NCT00655746|OG002|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
10918855|NCT00655746|OG003|Outcome|All Participants|
10918856|NCT00655746|EG000|Reported Event|BMS-354825 + Omeprazole|
10918857|NCT00655811|BG000|Baseline|Capsaicin and Placebo|"0.1% Topical Capsaicin cream was appled to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10963187|NCT00870740|OG004|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
10918858|NCT00655811|FG000|Participant Flow|Capsaicin and Placebo|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918859|NCT00655811|OG000|Outcome|African Americans|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918860|NCT00655811|OG001|Outcome|Caucasians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918861|NCT00655811|OG002|Outcome|East Asians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918862|NCT00655811|OG003|Outcome|Hispanics|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918863|NCT00655811|OG000|Outcome|Capsaicin|"0.1% Topical Capsaicin cream was applied to one forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918864|NCT00655811|OG001|Outcome|Placebo|"A placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918865|NCT00655811|EG000|Reported Event|Capsaicin|"0.1% Topical Capsaicin cream was applied to one forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918866|NCT00655811|EG001|Reported Event|Placebo|"A placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
10918867|NCT00655850|BG000|Baseline|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
10918868|NCT00655850|FG000|Participant Flow|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
10918869|NCT00655850|OG000|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
10918870|NCT00655850|OG000|Outcome|Paclitaxel and Gemcitabine + Avastin|Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
10918871|NCT00655850|OG000|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
10918872|NCT00655850|EG000|Reported Event|Paclitaxel and Gemcitabine + Avastin|Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
10918873|NCT00655863|BG000|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
10918874|NCT00655863|BG001|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
10918875|NCT00655863|BG002|Baseline|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
10918876|NCT00655863|BG003|Baseline|Total|Total of all reporting groups
10918877|NCT00655863|FG000|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
10918878|NCT00655863|FG001|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
10918879|NCT00655863|FG002|Participant Flow|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
10918880|NCT00655863|OG000|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
10918881|NCT00655863|OG001|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
10918882|NCT00655863|OG002|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
10918883|NCT00655863|EG000|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
10918884|NCT00655863|EG001|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
10918885|NCT00655863|EG002|Reported Event|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
10918886|NCT00655889|BG000|Baseline|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
10918887|NCT00655889|FG000|Participant Flow|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
10918888|NCT00655889|OG000|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
10918889|NCT00655889|EG000|Reported Event|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study (IT-G-002, no NCT identification number).
10918890|NCT00655928|BG000|Baseline|N-acetylcysteine|"Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively~N-acetylcysteine: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively"
10918891|NCT00655928|BG001|Baseline|Placebo|"Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively~0.9% saline: 0.9% saline 1 litre intravenous over 12 hours pre-operatively"
10918892|NCT00655928|BG002|Baseline|Total|Total of all reporting groups
10918893|NCT00655928|FG000|Participant Flow|N-acetylcysteine|"Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively~N-acetylcysteine: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively"
10918894|NCT00655928|FG001|Participant Flow|Placebo|"Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively~0.9% saline: 0.9% saline 1 litre intravenous over 12 hours pre-operatively"
10918895|NCT00655928|OG000|Outcome|N-acetylcysteine|"Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively~N-acetylcysteine: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively"
10918896|NCT00655928|OG001|Outcome|Placebo|"Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively~0.9% saline: 0.9% saline 1 litre intravenous over 12 hours pre-operatively"
10963188|NCT00870740|OG005|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
10918897|NCT00655928|EG000|Reported Event|N-acetylcysteine|"Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively~N-acetylcysteine: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively"
10918898|NCT00655928|EG001|Reported Event|Placebo|"Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively~0.9% saline: 0.9% saline 1 litre intravenous over 12 hours pre-operatively"
10918899|NCT00655980|BG000|Baseline|Treatment|"Vitamin B12 and folic acid~Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion"
10918900|NCT00655980|BG001|Baseline|Comparator|"Nitrous oxide and placebo~Nitrous oxide and placebo"
10918901|NCT00655980|BG002|Baseline|Standard of Care|"standard of care~standard of care"
10918902|NCT00655980|BG003|Baseline|Total|Total of all reporting groups
10918903|NCT00655980|FG000|Participant Flow|Treatment|"Vitamin B12 and folic acid~Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion"
10918904|NCT00655980|FG001|Participant Flow|Comparator|"Nitrous oxide and placebo~Nitrous oxide and placebo"
10918905|NCT00655980|FG002|Participant Flow|Standard of Care|"standard of care~standard of care"
10918906|NCT00655980|OG000|Outcome|B-Vitamin Group|"Vitamin B12 and folic acid~Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion"
10918907|NCT00655980|OG001|Outcome|Comparator|"Nitrous oxide and placebo~Nitrous oxide and placebo"
10918908|NCT00655980|OG002|Outcome|Standard of Care|Patients did neither receive nitrous oxide nor B-vitmamins
10918909|NCT00655980|OG000|Outcome|B-Vitamin Group|Vitamin B12 and folic acid
10918910|NCT00655980|OG001|Outcome|Comparator|Nitrous oxide and placebo
10918911|NCT00655980|OG002|Outcome|Standard of Care|No nitrous oxide No B-vitamins
10918912|NCT00655980|EG000|Reported Event|Treatment|"Vitamin B12 and folic acid~Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion"
10918913|NCT00655980|EG001|Reported Event|Comparator|"Nitrous oxide and placebo~Nitrous oxide and placebo"
10918914|NCT00655980|EG002|Reported Event|Standard of Care|"standard of care~standard of care"
10918915|NCT00656019|BG000|Baseline|No Intervention (No Vitamin D)|Patients with breast cancer detected by biopsy
10918916|NCT00656019|BG001|Baseline|2000 UI Vitamin D|Patients with breast cancer detected by biopsy
10918917|NCT00656019|BG002|Baseline|4000 UI Vitamin D|Patients with breast cancer detected by biopsy
10918918|NCT00656019|BG003|Baseline|6000 UI Vitamin D|Patients with breast cancer detected by biopsy
10918919|NCT00656019|BG004|Baseline|Total|Total of all reporting groups
10918920|NCT00656019|FG000|Participant Flow|Normal Vitamin D Levels|No additional Vitamin D administered
10918921|NCT00656019|FG001|Participant Flow|Low-normal Vitamin D Levels|2000 IU dose of Vitamin D per day administered orally
10918922|NCT00656019|FG002|Participant Flow|Low Vitamin D Levels|4000 IU dose of Vitamin D per day administered orally
10918923|NCT00656019|FG003|Participant Flow|Very-low Vitamin D Levels|6000 IU dose of Vitamin D per day administered orally
10918924|NCT00656019|OG000|Outcome|Normal Vitamin D Levels|No additional Vitamin D administered
10918925|NCT00656019|OG001|Outcome|Low-normal Vitamin D Levels|2000 IU dose of Vitamin D per day administered orally
10918926|NCT00656019|OG002|Outcome|Low Vitamin D Levels|4000 IU dose of Vitamin D per day administered orally
10918927|NCT00656019|OG003|Outcome|Very-low Vitamin D Levels|6000 IU dose of Vitamin D per day administered orally
10918928|NCT00656019|EG000|Reported Event|Vitamin D Normal|No Additional Vitamin D will be given (these patients have normal Vitamin D levels).
10918929|NCT00656019|EG001|Reported Event|Vitamin D Low-normal|"2000 IU dose of vitamin D per day (these patients have slightly low vitamin D levels).~Vitamin D: 2000 IU per day orally"
10918930|NCT00656019|EG002|Reported Event|Vitamin D Low|"4000 IU dose of vitamin D per day (these patients have low vitamin D levels).~Vitamin D: 4000 IU per day orally"
10918931|NCT00656019|EG003|Reported Event|Vitamin D Very Low|"6000 IU dose of vitamin D per day (these patients have very low vitamin D levels).~Vitamin D: 6000 IU per day orally"
10918932|NCT00656058|BG000|Baseline|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
10918933|NCT00656058|FG000|Participant Flow|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
10918934|NCT00656058|OG000|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
10918935|NCT00656058|EG000|Reported Event|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
10918936|NCT00656084|BG000|Baseline|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
10918937|NCT00656084|FG000|Participant Flow|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
10918938|NCT00656084|OG000|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
10918939|NCT00656084|EG000|Reported Event|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
10918940|NCT00656136|BG000|Baseline|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
10918941|NCT00656136|BG001|Baseline|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
10918942|NCT00656136|BG002|Baseline|Total|Total of all reporting groups
10918943|NCT00656136|FG000|Participant Flow|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
10918944|NCT00656136|FG001|Participant Flow|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus Best Supportive Care (BSC) or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
10918945|NCT00656136|OG000|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
10918946|NCT00656136|OG001|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
10918947|NCT00656136|EG000|Reported Event|Placebo|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
10918948|NCT00656136|EG001|Reported Event|Afatinib 50 mg/Day|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
10918949|NCT00656175|BG000|Baseline|Immediate|Immediate switch of PI or NNRTI to Raltegravir
10918950|NCT00656175|BG001|Baseline|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
10918951|NCT00656175|BG002|Baseline|Total|Total of all reporting groups
10918952|NCT00656175|FG000|Participant Flow|Immediate|Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily)
10918953|NCT00656175|FG001|Participant Flow|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)
10918954|NCT00656175|OG000|Outcome|Immediate|Immediate switch of PI or NNRTI to Raltegravir
10918955|NCT00656175|OG001|Outcome|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
10918956|NCT00656175|EG000|Reported Event|Immediate|Immediate switch of PI or NNRTI to Raltegravir
10918957|NCT00656175|EG001|Reported Event|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
10918958|NCT00656201|BG000|Baseline|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
10918959|NCT00656201|BG001|Baseline|Intramuscular Progesterone|"Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.~."
10918960|NCT00656201|BG002|Baseline|Total|Total of all reporting groups
10918961|NCT00656201|FG000|Participant Flow|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
10918962|NCT00656201|FG001|Participant Flow|Intramuscular Progesterone|"Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.~."
10918963|NCT00656201|OG000|Outcome|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
10918964|NCT00656201|OG001|Outcome|Intramuscular Progesterone|"Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.~."
10918965|NCT00656201|EG000|Reported Event|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
10918966|NCT00656201|EG001|Reported Event|Intramuscular Progesterone|"Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.~."
10918967|NCT00656292|BG000|Baseline|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
10918968|NCT00656292|BG001|Baseline|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
10918969|NCT00656292|BG002|Baseline|Total|Total of all reporting groups
10963189|NCT00870740|OG000|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
10918970|NCT00656292|FG000|Participant Flow|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
10918971|NCT00656292|FG001|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
10918972|NCT00656292|OG000|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
10918973|NCT00656292|OG001|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
10918974|NCT00656292|EG000|Reported Event|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
10918975|NCT00656292|EG001|Reported Event|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
10918976|NCT00656305|BG000|Baseline|ExAblate Treatment Arm|ExAblate 2000: MR guided focused ultrasound
10918977|NCT00656305|BG001|Baseline|ExAblate Sham Control Arm|ExAblate 2000: MR guided focused ultrasound sham
10918978|NCT00656305|BG002|Baseline|Total|Total of all reporting groups
10918979|NCT00656305|FG000|Participant Flow|ExAblate Treatment Arm|ExAblate 2000: MR guided focused ultrasound
10918980|NCT00656305|FG001|Participant Flow|ExAblate Sham Control Arm|ExAblate 2000: MR guided focused ultrasound sham
10918981|NCT00656305|OG000|Outcome|ExAblate Treatment Arm|ExAblate 2000: MR guided focused ultrasound
10918982|NCT00656305|OG001|Outcome|ExAblate Sham Control Arm|ExAblate 2000: MR guided focused ultrasound sham
10918983|NCT00656305|EG000|Reported Event|ExAblate Treatment Arm|ExAblate 2000: MR guided focused ultrasound
10918984|NCT00656305|EG001|Reported Event|ExAblate Sham Control Arm|ExAblate 2000: MR guided focused ultrasound sham
10918985|NCT00656370|BG000|Baseline|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
10918986|NCT00656370|FG000|Participant Flow|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
10918987|NCT00656370|OG000|Outcome|NS Infusion Group|"Normal Saline (NS) and Hylenex~recombinant human hyaluronidase: 150 Units in 1mL"
10918988|NCT00656370|OG001|Outcome|LR Infusion Group|"Lactated Ringer's (LR) and Hylenex~recombinant human hyaluronidase: 150 Units in 1mL"
10918989|NCT00656370|OG000|Outcome|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
10963190|NCT00870740|OG001|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
11234037|NCT02431806|EG000|Reported Event|Placebo|Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
10918990|NCT00656370|EG000|Reported Event|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
10918991|NCT00656448|BG000|Baseline|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
10918992|NCT00656448|BG001|Baseline|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
10918993|NCT00656448|BG002|Baseline|Total|Total of all reporting groups
10918994|NCT00656448|FG000|Participant Flow|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
10918995|NCT00656448|FG001|Participant Flow|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
10918996|NCT00656448|OG000|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
10918997|NCT00656448|OG001|Outcome|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
10918998|NCT00656448|OG001|Outcome|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
10918999|NCT00656448|EG000|Reported Event|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
10919000|NCT00656448|EG001|Reported Event|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
10919001|NCT00656474|BG000|Baseline|GLYC-101 and Placebo|Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
10919002|NCT00656474|FG000|Participant Flow|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.~GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
11174959|NCT02025985|FG002|Participant Flow|Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
10919003|NCT00656474|OG000|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
10919004|NCT00656474|OG001|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
10919005|NCT00656474|EG000|Reported Event|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.~GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
10919006|NCT00656487|BG000|Baseline|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
11191859|NCT02134587|OG000|Outcome|Subjects Post Educational Intervention|"Skills of health professionals in fill correctly the adverse drug events form after multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
10919007|NCT00656487|BG001|Baseline|Placebo|Participants were cannabis dependent and received matched placebo.
10919008|NCT00656487|BG002|Baseline|Control|Participants were non-cannabis using controls.
10919009|NCT00656487|BG003|Baseline|Total|Total of all reporting groups
10919010|NCT00656487|FG000|Participant Flow|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
10919011|NCT00656487|FG001|Participant Flow|Placebo|Participants were cannabis dependent and received matched placebo.
10919012|NCT00656487|FG002|Participant Flow|Control|Participants were non-cannabis using controls.
10919013|NCT00656487|OG000|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
10919014|NCT00656487|OG001|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
10919015|NCT00656487|OG002|Outcome|Control|Participants were non-cannabis using controls.
10919016|NCT00656487|EG000|Reported Event|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
10919017|NCT00656487|EG001|Reported Event|Placebo|Participants were cannabis dependent and received matched placebo.
10919018|NCT00656487|EG002|Reported Event|Control|Participants were non-cannabis using controls.
10919019|NCT00656513|BG000|Baseline|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
10919020|NCT00656513|BG001|Baseline|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
10919021|NCT00656513|BG002|Baseline|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
10919022|NCT00656513|BG003|Baseline|Total|Total of all reporting groups
10919023|NCT00656513|FG000|Participant Flow|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
10919024|NCT00656513|FG001|Participant Flow|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
10919025|NCT00656513|FG002|Participant Flow|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
10919026|NCT00656513|OG000|Outcome|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
10919027|NCT00656513|OG000|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
10919028|NCT00656513|OG001|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
10919029|NCT00656513|EG000|Reported Event|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
10919030|NCT00656513|EG001|Reported Event|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
10919031|NCT00656513|EG002|Reported Event|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
10919032|NCT00656617|BG000|Baseline|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
10919033|NCT00656617|FG000|Participant Flow|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
10919034|NCT00656617|OG000|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
10919035|NCT00656617|EG000|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 1)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
10919036|NCT00656617|EG001|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 2)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
10919037|NCT00656630|BG000|Baseline|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
10919038|NCT00656630|BG001|Baseline|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
10919039|NCT00656630|BG002|Baseline|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
10919040|NCT00656630|BG003|Baseline|Total|Total of all reporting groups
10919041|NCT00656630|FG000|Participant Flow|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
10919042|NCT00656630|FG001|Participant Flow|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
10919043|NCT00656630|FG002|Participant Flow|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
10919044|NCT00656630|OG000|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
10919045|NCT00656630|OG001|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
10919046|NCT00656630|OG002|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
10919047|NCT00656630|EG000|Reported Event|Acamprosate|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
10919048|NCT00656630|EG001|Reported Event|Naltrexone|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
10919049|NCT00656630|EG002|Reported Event|Placebo|Placebo: Double-dummy placebo capsules, 1 week duration
10919050|NCT00656656|BG000|Baseline|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
10919051|NCT00656656|FG000|Participant Flow|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
10919052|NCT00656656|OG000|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
10919053|NCT00656656|EG000|Reported Event|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
10919054|NCT00656669|BG000|Baseline|Overall Study|These patients are for the patients who were into the trial.
11191860|NCT02134587|OG001|Outcome|Subjects Prior to Educational Intervention|Skills of health professionals in fill correctly the adverse drug events form before educational intervention
11191861|NCT02134587|EG000|Reported Event|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
10919055|NCT00656669|FG000|Participant Flow|Segment Information|This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.
10919056|NCT00656669|OG000|Outcome|Sunitinib Monotherapy|Patients who completed the Sunitinib monotherapy segment
10919057|NCT00656669|OG000|Outcome|Paclitaxel Plus Sunitinib|Patients who finished the paclitaxel plus sunitinib segment
10919058|NCT00656669|OG000|Outcome|AC Dosing|Patients who finished the AC dosing segment
10919059|NCT00656669|OG000|Outcome|Paclitaxel Plus Sunitinib|Patients who were in the paclitaxel plus sunitinib segment
10919060|NCT00656669|EG000|Reported Event|Single Agent Sunitinib|Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.
10919061|NCT00656669|EG001|Reported Event|Paclitaxel/Sunitinib|4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
10919062|NCT00656669|EG002|Reported Event|AC Dosing|4 cycles (8 weeks) of neoadjuvant treatment with AC.
10919063|NCT00656799|BG000|Baseline|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
10919064|NCT00656799|FG000|Participant Flow|Sugammadex|Intravenous (IV) single bolus dose of 4.0 mg/kg sugammadex
10919065|NCT00656799|OG000|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
10919066|NCT00656799|EG000|Reported Event|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
10919067|NCT00656851|BG000|Baseline|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
10919068|NCT00656851|BG001|Baseline|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
10919069|NCT00656851|BG002|Baseline|Total|Total of all reporting groups
10919070|NCT00656851|FG000|Participant Flow|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
10919071|NCT00656851|FG001|Participant Flow|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
10919072|NCT00656851|OG000|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
10919073|NCT00656851|OG001|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
10919074|NCT00656851|EG000|Reported Event|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
10919075|NCT00656851|EG001|Reported Event|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
10919076|NCT00656968|BG000|Baseline|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
10919077|NCT00656968|BG001|Baseline|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
10919078|NCT00656968|BG002|Baseline|Total|Total of all reporting groups
10919079|NCT00656968|FG000|Participant Flow|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
10919080|NCT00656968|FG001|Participant Flow|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
10919081|NCT00656968|OG000|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
10919082|NCT00656968|OG001|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
10919083|NCT00656968|EG000|Reported Event|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
10919084|NCT00656968|EG001|Reported Event|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
10919085|NCT00657020|BG000|Baseline|All Randomized Participants|All randomized participants who receive study treatments.
10919086|NCT00657020|FG000|Participant Flow|4 mg Nicotine Lozenge Then Placebo Lozenge|Participants received nicotine lozenge containing 4 milligrams (mg) of nicotine in Period I and placebo lozenge in Period II.
10919087|NCT00657020|FG001|Participant Flow|Placebo Lozenge Then 4 mg Nicotine Lozenge|Participants received placebo lozenge in Period I and nicotine 4 mg lozenge in Period II.
10919088|NCT00657020|OG000|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
10919089|NCT00657020|OG001|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
10919090|NCT00657020|OG002|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
10919091|NCT00657020|OG003|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
10919092|NCT00657020|OG000|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
10919093|NCT00657020|OG001|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
10919094|NCT00657020|OG002|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
10919095|NCT00657020|OG003|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
10919096|NCT00657020|EG000|Reported Event|Nicotine Lozenge|Participants in safety population received 4 mg of nicotine lozenge.
10919097|NCT00657020|EG001|Reported Event|Placebo Lozenge|Participants in safety population received placebo lozenge.
10919098|NCT00657046|BG000|Baseline|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919099|NCT00657046|BG001|Baseline|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919100|NCT00657046|BG002|Baseline|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919101|NCT00657046|BG003|Baseline|Total|Total of all reporting groups
10919102|NCT00657046|FG000|Participant Flow|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919103|NCT00657046|FG001|Participant Flow|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919104|NCT00657046|FG002|Participant Flow|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919105|NCT00657046|OG000|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919106|NCT00657046|OG001|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919107|NCT00657046|OG002|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919108|NCT00657046|EG000|Reported Event|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919109|NCT00657046|EG001|Reported Event|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919110|NCT00657046|EG002|Reported Event|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
10919111|NCT00657150|BG000|Baseline|Dabigatran 220mg|qd (once daily) oral
10919112|NCT00657150|BG001|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
10919113|NCT00657150|BG002|Baseline|Total|Total of all reporting groups
10919114|NCT00657150|FG000|Participant Flow|Dabigatran 220mg|qd (once daily) oral
10919115|NCT00657150|FG001|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
10919116|NCT00657150|OG000|Outcome|Dabigatran 220mg|qd (once daily) oral
10919117|NCT00657150|OG001|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
10919118|NCT00657150|EG000|Reported Event|Dabigatran 220mg|qd (once daily) oral
10919119|NCT00657150|EG001|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
10919120|NCT00657267|BG000|Baseline|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
10919121|NCT00657267|FG000|Participant Flow|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
10919122|NCT00657267|OG000|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
10919123|NCT00657267|OG000|Outcome|Partial Response|Partial Responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
10919124|NCT00657267|OG001|Outcome|Complete Response|Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
10919125|NCT00657267|EG000|Reported Event|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|All 58 participants who started treatment: Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets
10963191|NCT00870740|OG002|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
10963192|NCT00870740|OG001|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
10963193|NCT00870740|OG002|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
10963194|NCT00870740|OG001|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
11191862|NCT02134756|BG000|Baseline|NutraStem Active|"Daily supplementation with NutraStem Active; 2 capsules per day for 28 days~NutraStem Active"
11191863|NCT02134756|BG001|Baseline|Placebo|"Daily supplementation with placebo; 2 capsules per day for 28 days~NutraStem Active"
11191864|NCT02134756|BG002|Baseline|Total|Total of all reporting groups
11191865|NCT02134756|FG000|Participant Flow|NutraStem Active|2 capsules per day for 28 days
10919126|NCT00657280|BG000|Baseline|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
10919127|NCT00657280|FG000|Participant Flow|Sitagliptin|There is only one group. All the participants took Sitagliptin 100mg daily and acted as their own controls
10919128|NCT00657280|OG000|Outcome|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
10919129|NCT00657280|EG000|Reported Event|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
10919130|NCT00657358|BG000|Baseline|Lidocaine|Healthy Volunteers receiving Lidocaine
10919131|NCT00657358|FG000|Participant Flow|Lidocaine|Healthy Volunteers receiving Lidocaine
10919132|NCT00657358|OG000|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
10919133|NCT00657358|OG000|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.infused within 20 minutes.
10919134|NCT00657358|EG000|Reported Event|Lidocaine|Healthy Volunteers receiving Lidocaine
10919135|NCT00657371|BG000|Baseline|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
10919136|NCT00657371|FG000|Participant Flow|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
10919137|NCT00657371|OG000|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
10919138|NCT00657371|EG000|Reported Event|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
10919139|NCT00657540|BG000|Baseline|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
10919140|NCT00657540|BG001|Baseline|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
10919141|NCT00657540|BG002|Baseline|Total|Total of all reporting groups
10919142|NCT00657540|FG000|Participant Flow|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
10919143|NCT00657540|FG001|Participant Flow|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
10919144|NCT00657540|OG000|Outcome|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
10919145|NCT00657540|OG001|Outcome|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
10919146|NCT00657540|EG000|Reported Event|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
10919147|NCT00657540|EG001|Reported Event|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
10919148|NCT00657605|BG000|Baseline|Recombinant Methionyl Human Leptin|Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
10919149|NCT00657605|FG000|Participant Flow|Recombinant Methionyl Human Leptin|Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
10919150|NCT00657605|OG000|Outcome|Recombinant Methionyl Human Leptin|Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
10919151|NCT00657605|EG000|Reported Event|Recombinant Methionyl Human Leptin|Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
10919152|NCT00657618|BG000|Baseline|Sodium Stibogluconate (SSG)|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
10919153|NCT00657618|FG000|Participant Flow|Sodium Stibogluconate (SSG)|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
10919154|NCT00657618|OG000|Outcome|Treatment Only|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
11191866|NCT02134756|FG001|Participant Flow|Placebo|2 capsules per day for 28 days
11191867|NCT02134756|OG000|Outcome|NutraStem Active|"Daily supplementation with NutraStem Active; 2 capsules per day for 28 days~NutraStem Active"
11191868|NCT02134756|OG001|Outcome|Placebo|"Daily supplementation with placebo; 2 capsules per day for 28 days~NutraStem Active"
11191869|NCT02134756|EG000|Reported Event|NutraStem Active|Daily supplementation with NutraStem Active; 2 capsules per day for 28 days
10919155|NCT00657618|EG000|Reported Event|Treatment Only|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
10919156|NCT00657657|BG000|Baseline|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
10919157|NCT00657657|FG000|Participant Flow|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
10919158|NCT00657657|OG000|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
10919159|NCT00657657|EG000|Reported Event|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
10919160|NCT00657709|BG000|Baseline|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919161|NCT00657709|BG001|Baseline|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919162|NCT00657709|BG002|Baseline|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919163|NCT00657709|BG003|Baseline|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
10919164|NCT00657709|BG004|Baseline|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
10919165|NCT00657709|BG005|Baseline|Total|Total of all reporting groups
10919166|NCT00657709|FG000|Participant Flow|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919167|NCT00657709|FG001|Participant Flow|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919168|NCT00657709|FG002|Participant Flow|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919169|NCT00657709|FG003|Participant Flow|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
10919170|NCT00657709|FG004|Participant Flow|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
10919171|NCT00657709|OG000|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919172|NCT00657709|OG001|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919173|NCT00657709|OG002|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919174|NCT00657709|OG000|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919175|NCT00657709|OG001|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
10919176|NCT00657709|OG003|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
10919177|NCT00657709|OG000|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919178|NCT00657709|OG003|Outcome|rMenB All|Subjects received one injection fo rMenB+OMV NZ (Lot1, or Lot 2, or Lot 3) at 2, 4, and 6months of age concomitantly with the routinely administered infant vaccines.
10919179|NCT00657709|OG004|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
10919180|NCT00657709|OG000|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ(Lot1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919181|NCT00657709|OG002|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ(Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919182|NCT00657709|OG003|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot2, or Lot3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919183|NCT00657709|OG001|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ(Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919184|NCT00657709|OG003|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919185|NCT00657709|OG001|Outcome|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
10919186|NCT00657709|EG000|Reported Event|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919187|NCT00657709|EG001|Reported Event|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919188|NCT00657709|EG002|Reported Event|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
10919189|NCT00657709|EG003|Reported Event|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
10919190|NCT00657709|EG004|Reported Event|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
10919191|NCT00657917|BG000|Baseline|Paromomycin +Gentamicin Topical Cream|"WR279,396 topically twice a day for 20 days~Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy."
10919192|NCT00657917|FG000|Participant Flow|Paromomycin +Gentamicin Topical Cream|"WR279,396 topically twice a day for 20 days~Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy."
10919193|NCT00657917|OG000|Outcome|Paromomycin +Gentamicin Topical Cream|"WR279,396 topically twice a day for 20 days~Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy."
10919194|NCT00657917|EG000|Reported Event|Paromomycin +Gentamicin Topical Cream|"WR279,396 topically twice a day for 20 days~Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy."
10919195|NCT00658021|BG000|Baseline|Exenatide 5 mcg|Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919196|NCT00658021|BG001|Baseline|Exenatide 10 mcg|Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919197|NCT00658021|BG002|Baseline|Placebo|Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919198|NCT00658021|BG003|Baseline|Total|Total of all reporting groups
10919199|NCT00658021|FG000|Participant Flow|Exenatide 5 mcg|Adolescent participants received exenatide 5 mcg subcutaneous (SC) injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 millimeter (mm) between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919200|NCT00658021|FG001|Participant Flow|Exenatide 10 mcg|Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919201|NCT00658021|FG002|Participant Flow|Placebo|Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919202|NCT00658021|OG000|Outcome|Total Exenatide Twice Daily (EBID)|"Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo.~Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks."
10919203|NCT00658021|OG001|Outcome|Placebo|Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919204|NCT00658021|OG000|Outcome|Exenatide 5 mcg|Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919205|NCT00658021|OG001|Outcome|Exenatide 10 mcg|Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919206|NCT00658021|OG002|Outcome|Placebo|Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
10919207|NCT00658021|EG000|Reported Event|Exenatide 5 mcg|Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks.
10919208|NCT00658021|EG001|Reported Event|Exenatide 10 mcg|Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks.
10919209|NCT00658021|EG002|Reported Event|Placebo|Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks.
10963195|NCT00870740|OG002|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
10919210|NCT00658112|BG000|Baseline|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
10919211|NCT00658112|FG000|Participant Flow|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
10919212|NCT00658112|OG000|Outcome|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
10919213|NCT00658112|EG000|Reported Event|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
10919214|NCT00658138|BG000|Baseline|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
10919215|NCT00658138|FG000|Participant Flow|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
10919216|NCT00658138|OG000|Outcome|Scotchbond SE|3M ESPE Adper Scotchbond SE
10919217|NCT00658138|OG001|Outcome|Scotchbond 1XT|3M ESPE Adper Scotchbond 1XT
10919218|NCT00658138|EG000|Reported Event|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
10919219|NCT00658320|BG000|Baseline|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
10919220|NCT00658320|BG001|Baseline|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
10919221|NCT00658320|BG002|Baseline|Total|Total of all reporting groups
10919222|NCT00658320|FG000|Participant Flow|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
10919223|NCT00658320|FG001|Participant Flow|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
10963196|NCT00870740|OG003|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
11191870|NCT02134756|EG001|Reported Event|Placebo|Daily supplementation with placebo; 2 capsules per day for 28 days
10919224|NCT00658320|OG000|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
10919225|NCT00658320|OG001|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
10919226|NCT00658320|OG000|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
10919227|NCT00658320|OG001|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
10919228|NCT00658320|EG000|Reported Event|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
10919229|NCT00658320|EG001|Reported Event|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
10919230|NCT00658333|BG000|Baseline|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
10919231|NCT00658333|BG001|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
10919232|NCT00658333|BG002|Baseline|Total|Total of all reporting groups
10919233|NCT00658333|FG000|Participant Flow|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
10919234|NCT00658333|FG001|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
10919235|NCT00658333|OG000|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
10919236|NCT00658333|OG001|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
10919237|NCT00658333|EG000|Reported Event|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
10919238|NCT00658333|EG001|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
10919239|NCT00658359|BG000|Baseline|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
11191871|NCT02134951|BG000|Baseline|Ketamine|randomized to ketamine
11191872|NCT02134951|BG001|Baseline|Placebo|randomized to placebo
11191873|NCT02134951|BG002|Baseline|Total|Total of all reporting groups
10919240|NCT00658359|BG001|Baseline|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919241|NCT00658359|BG002|Baseline|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919242|NCT00658359|BG003|Baseline|Total|Total of all reporting groups
10919243|NCT00658359|FG000|Participant Flow|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919244|NCT00658359|FG001|Participant Flow|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919245|NCT00658359|FG002|Participant Flow|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919246|NCT00658359|OG000|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
11174960|NCT02025985|FG003|Participant Flow|Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIWmg/m^2|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174961|NCT02025985|FG004|Participant Flow|Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174962|NCT02025985|OG000|Outcome|Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11191874|NCT02134951|FG000|Participant Flow|Ketamine|"IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes~Ketamine: intravenous infusion of saline solution with ketamine"
11191875|NCT02134951|FG001|Participant Flow|Placebo|"Placebo group will receive normal saline~Normal saline: Normal saline will be used for placebo in this group"
11191876|NCT02134951|OG000|Outcome|Ketamine|"IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes~Ketamine: intravenous infusion of saline solution with ketamine"
10919247|NCT00658359|OG001|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919248|NCT00658359|OG002|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919249|NCT00658359|OG000|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919250|NCT00658359|OG001|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919251|NCT00658359|EG000|Reported Event|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919252|NCT00658359|EG001|Reported Event|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919253|NCT00658359|EG002|Reported Event|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
10919254|NCT00658385|BG000|Baseline|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
10919255|NCT00658385|FG000|Participant Flow|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
10963197|NCT00870740|OG004|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
10919256|NCT00658385|OG000|Outcome|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
10919257|NCT00658385|EG000|Reported Event|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
10919258|NCT00658411|BG000|Baseline|All Patients|Deferoxamine prior to stem cells
10919259|NCT00658411|FG000|Participant Flow|All Patients|Deferoxamine for >= 2 weeks prior to stem cells
10919260|NCT00658411|OG000|Outcome|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
11174963|NCT02025985|OG001|Outcome|Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
10919261|NCT00658411|OG000|Outcome|Transplant-Related Mortality (Deferoxamine)|Patients who received Deferoxamine and passed away as a result of transplant or study treatment without prior relapse at 1 year.
10919262|NCT00658411|OG001|Outcome|Relapse (Deferoxamine)|Patients who received Deferoxamine and relapsed post transplant at 1 year.
10919263|NCT00658411|OG002|Outcome|Disease-Free Survival (Deferoxamine)|Patients who received Deferoxamine and are currently alive without incidence of relapse at 1 year.
10919264|NCT00658411|OG003|Outcome|Overall Survival (Deferoxamine)|Patients who received Deferoxamine and have relapsed and is alive at 1 year.
10919265|NCT00658411|EG000|Reported Event|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
10919266|NCT00658515|BG000|Baseline|Dalcetrapib (RO4607381)|"Dalcetrapib (RO4607381): 600mg po daily~Evidence-based medical care for Acute Coronary Syndrome: As prescribed"
10919267|NCT00658515|BG001|Baseline|Placebo|"Evidence-based medical care for Acute Coronary Syndrome: As prescribed~Placebo: po daily"
10919268|NCT00658515|BG002|Baseline|Total|Total of all reporting groups
10919269|NCT00658515|FG000|Participant Flow|Dalcetrapib (RO4607381)|"Dalcetrapib (RO4607381): 600mg po daily~Evidence-based medical care for Acute Coronary Syndrome: As prescribed"
10919270|NCT00658515|FG001|Participant Flow|Placebo|"Evidence-based medical care for Acute Coronary Syndrome: As prescribed~Placebo: po daily"
10919271|NCT00658515|OG000|Outcome|Dalcetrapib (RO4607381)|"Dalcetrapib (RO4607381): 600mg po daily~Evidence-based medical care for Acute Coronary Syndrome: As prescribed"
10919272|NCT00658515|OG001|Outcome|Placebo|"Evidence-based medical care for Acute Coronary Syndrome: As prescribed~Placebo: po daily"
10919273|NCT00658515|EG000|Reported Event|Dalcetrapib (RO4607381)|"Dalcetrapib (RO4607381): 600mg po daily~Evidence-based medical care for Acute Coronary Syndrome: As prescribed"
10919274|NCT00658515|EG001|Reported Event|Placebo|"Evidence-based medical care for Acute Coronary Syndrome: As prescribed~Placebo: po daily"
10919275|NCT00658528|BG000|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
10919276|NCT00658528|BG001|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
10919277|NCT00658528|BG002|Baseline|Total|Total of all reporting groups
10919278|NCT00658528|FG000|Participant Flow|ESO 40 mg|Esomeprazole (ESO) 40 mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50 mg capsule), once daily for 4 to 8 weeks.
10919279|NCT00658528|FG001|Participant Flow|RAB ER 50 mg|Rabeprazole (RAB) Extended Release (ER) 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
10919280|NCT00658528|OG000|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
11191877|NCT02134951|OG001|Outcome|Placebo|"Placebo group will receive normal saline~Normal saline: Normal saline will be used for placebo in this group"
11191878|NCT02134951|EG000|Reported Event|Ketamine|
11191879|NCT02134951|EG001|Reported Event|Placebo|
11191880|NCT02134977|BG000|Baseline|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
10919281|NCT00658528|OG001|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
10919282|NCT00658528|EG000|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
10919283|NCT00658528|EG001|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
10919284|NCT00658541|BG000|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
10919285|NCT00658541|FG000|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 following an an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
10919286|NCT00658541|FG001|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
10919287|NCT00658541|OG000|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
10919288|NCT00658541|OG001|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
10919289|NCT00658541|EG000|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
10919290|NCT00658541|EG001|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
10919291|NCT00658567|BG000|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
10919292|NCT00658567|BG001|Baseline|10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
11234038|NCT02431806|EG001|Reported Event|Levomilnacipran 40 mg/Day|Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
10919293|NCT00658567|BG002|Baseline|20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
10919294|NCT00658567|BG003|Baseline|Total|Total of all reporting groups
10919295|NCT00658567|FG000|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
10919296|NCT00658567|FG001|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
10919297|NCT00658567|FG002|Participant Flow|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
10919298|NCT00658567|OG000|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
10919299|NCT00658567|OG001|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
10919300|NCT00658567|OG002|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
10919301|NCT00658567|EG000|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
10919302|NCT00658567|EG001|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
10919303|NCT00658567|EG002|Reported Event|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
10919304|NCT00658606|BG000|Baseline|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
10919305|NCT00658606|BG001|Baseline|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
10919306|NCT00658606|BG002|Baseline|Total|Total of all reporting groups
10919307|NCT00658606|FG000|Participant Flow|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
10919308|NCT00658606|FG001|Participant Flow|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
10919309|NCT00658606|OG000|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
10919310|NCT00658606|OG001|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
10919311|NCT00658606|EG000|Reported Event|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
10919312|NCT00658606|EG001|Reported Event|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
10919313|NCT00658619|BG000|Baseline|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919314|NCT00658619|BG001|Baseline|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919315|NCT00658619|BG002|Baseline|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919316|NCT00658619|BG003|Baseline|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919317|NCT00658619|BG004|Baseline|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
10919318|NCT00658619|BG005|Baseline|Total|Total of all reporting groups
10919319|NCT00658619|FG000|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919320|NCT00658619|FG001|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919321|NCT00658619|FG002|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919322|NCT00658619|FG003|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919323|NCT00658619|FG004|Participant Flow|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
10919324|NCT00658619|OG000|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919325|NCT00658619|OG001|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919326|NCT00658619|OG002|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
10919327|NCT00658619|OG001|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
10919328|NCT00658619|EG000|Reported Event|400 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919329|NCT00658619|EG001|Reported Event|200 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
10919330|NCT00658619|EG002|Reported Event|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
10919331|NCT00658632|BG000|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
10919332|NCT00658632|BG001|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
10919333|NCT00658632|BG002|Baseline|Total|Total of all reporting groups
10919334|NCT00658632|FG000|Participant Flow|Esomeprazole (ESO) 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
10919335|NCT00658632|FG001|Participant Flow|Rabeprazole (RAB) Extended Release (ER) 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
10919336|NCT00658632|OG000|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
10919337|NCT00658632|OG001|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
10919338|NCT00658632|EG000|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
10919339|NCT00658632|EG001|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
10919340|NCT00658658|BG000|Baseline|Age 12-17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919341|NCT00658658|BG001|Baseline|Age 12-17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919342|NCT00658658|BG002|Baseline|Age 12-17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919343|NCT00658658|BG003|Baseline|Age 1-11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919344|NCT00658658|BG004|Baseline|Age 1-11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919345|NCT00658658|BG005|Baseline|Total|Total of all reporting groups
10919346|NCT00658658|FG000|Participant Flow|Age 12-17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919347|NCT00658658|FG001|Participant Flow|Age 12-17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919348|NCT00658658|FG002|Participant Flow|Age 12-17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919349|NCT00658658|FG003|Participant Flow|Age 1-11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919350|NCT00658658|FG004|Participant Flow|Age 1-11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919351|NCT00658658|OG000|Outcome|Age 12-17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919352|NCT00658658|OG001|Outcome|Age 12-17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919353|NCT00658658|OG002|Outcome|Age 12-17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919354|NCT00658658|OG003|Outcome|Age 1-11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919355|NCT00658658|OG004|Outcome|Age 1-11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919356|NCT00658658|EG000|Reported Event|Age 12-17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919357|NCT00658658|EG001|Reported Event|Age 12-17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919358|NCT00658658|EG002|Reported Event|Age 12-17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919359|NCT00658658|EG003|Reported Event|Age 1-11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919360|NCT00658658|EG004|Reported Event|Age 1-11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
10919361|NCT00658684|BG000|Baseline|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
10919362|NCT00658684|BG001|Baseline|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
10919363|NCT00658684|BG002|Baseline|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
10919364|NCT00658684|BG003|Baseline|Total|Total of all reporting groups
10919365|NCT00658684|FG000|Participant Flow|Total|All subjects
10919366|NCT00658684|FG001|Participant Flow|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
10919367|NCT00658684|FG002|Participant Flow|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
10919368|NCT00658684|FG003|Participant Flow|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
10919369|NCT00658684|OG000|Outcome|Total|All subjects
10919370|NCT00658684|OG001|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
10919371|NCT00658684|OG002|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
10919372|NCT00658684|OG003|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
10919373|NCT00658684|EG000|Reported Event|Total|All subjects
10919374|NCT00658684|EG001|Reported Event|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
10919375|NCT00658684|EG002|Reported Event|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
10919376|NCT00658684|EG003|Reported Event|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
10963198|NCT00870740|OG005|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
10919377|NCT00658697|BG000|Baseline|Docetaxel, Bevacizumab, and Androgen Deprivation Therapy (ADT)|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~Androgen deprivation therapy (ADT) or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
10919378|NCT00658697|FG000|Participant Flow|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
10919379|NCT00658697|OG000|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
10919380|NCT00658697|OG000|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
10919381|NCT00658697|OG000|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
10919382|NCT00658697|EG000|Reported Event|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
10919383|NCT00658723|BG000|Baseline|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
10919384|NCT00658723|BG001|Baseline|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
10919385|NCT00658723|BG002|Baseline|Total|Total of all reporting groups
10919386|NCT00658723|FG000|Participant Flow|Fibrin Pad Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
11234039|NCT02431806|EG002|Reported Event|Levomilnacipran 80 mg/Day|Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
10919387|NCT00658723|FG001|Participant Flow|SURGICEL™ Randomized|"SURGICEL™ Absorbable Hemostat~SURGICEL™: Absorbable hemostat"
10919388|NCT00658723|FG002|Participant Flow|Fibrin Pad Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). (Non - Randomized)
11234040|NCT02431806|EG003|Reported Event|Fluoxetine 20 mg/Day|Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
10919389|NCT00658723|OG000|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
10919390|NCT00658723|OG001|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
10919391|NCT00658723|OG002|Outcome|Fibrin Pad - Non-Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
10919392|NCT00658723|OG002|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
10919393|NCT00658723|OG002|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
10919394|NCT00658723|OG000|Outcome|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
10919395|NCT00658723|OG001|Outcome|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
10919396|NCT00658723|EG000|Reported Event|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
10919397|NCT00658723|EG001|Reported Event|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
10919398|NCT00658736|BG000|Baseline|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
10919399|NCT00658736|BG001|Baseline|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
10919400|NCT00658736|BG002|Baseline|Total|Total of all reporting groups
10919401|NCT00658736|FG000|Participant Flow|Bupivicaine Alone|EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution.
10919402|NCT00658736|FG001|Participant Flow|Bupivicaine Plus Triamcinolone|EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution mixed with 80 mg Triamcinolone.
10919403|NCT00658736|OG000|Outcome|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
10919404|NCT00658736|OG001|Outcome|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
10919405|NCT00658736|EG000|Reported Event|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
10919406|NCT00658736|EG001|Reported Event|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
10919407|NCT00658775|BG000|Baseline|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
10919408|NCT00658775|BG001|Baseline|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
10919409|NCT00658775|BG002|Baseline|Total|Total of all reporting groups
10919410|NCT00658775|FG000|Participant Flow|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
10919411|NCT00658775|FG001|Participant Flow|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
10919412|NCT00658775|OG000|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
10919413|NCT00658775|OG001|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
10919414|NCT00658775|EG000|Reported Event|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
10919415|NCT00658775|EG001|Reported Event|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
10919416|NCT00658788|BG000|Baseline|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
10919417|NCT00658788|FG000|Participant Flow|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
10919418|NCT00658788|OG000|Outcome|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
10919419|NCT00658788|OG000|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919420|NCT00658788|OG001|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919421|NCT00658788|OG002|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919422|NCT00658788|OG003|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919423|NCT00658788|OG000|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919424|NCT00658788|OG001|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919425|NCT00658788|OG002|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919426|NCT00658788|OG003|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919427|NCT00658788|OG004|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
10919428|NCT00658788|EG000|Reported Event|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
10919429|NCT00658879|BG000|Baseline|Somavert (Pegvisomant)|Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
10919430|NCT00658879|FG000|Participant Flow|Somavert (Pegvisomant)|Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
10919431|NCT00658879|OG000|Outcome|Somavert (Pegvisomant)|Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
10919432|NCT00658879|EG000|Reported Event|Somavert (Pegvisomant)|Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
10919433|NCT00658996|BG000|Baseline|Entire Study Population|Population enrolled at start of study
10919434|NCT00658996|FG000|Participant Flow|SofLens DD Toric First, Then Focus Dailies Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens
10919435|NCT00658996|FG001|Participant Flow|Focus Dailies Toric First, Then SofLens DD Toric|Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
10919436|NCT00658996|OG000|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
10919437|NCT00658996|OG001|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
10919438|NCT00658996|EG000|Reported Event|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
10919439|NCT00658996|EG001|Reported Event|Ciba Vision Toric Lens|Ciba Vision Focus Dailies Toric Lens
10919440|NCT00659165|BG000|Baseline|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
10919441|NCT00659165|BG001|Baseline|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
10919442|NCT00659165|BG002|Baseline|Total|Total of all reporting groups
10919443|NCT00659165|FG000|Participant Flow|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
10919444|NCT00659165|FG001|Participant Flow|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
10919445|NCT00659165|OG000|Outcome|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
10919446|NCT00659165|OG001|Outcome|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
10919447|NCT00659165|EG000|Reported Event|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
10919448|NCT00659165|EG001|Reported Event|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
10919449|NCT00659230|BG000|Baseline|Placebo|"Arm 1~Placebo: 100-800mg placebo"
10919450|NCT00659230|BG001|Baseline|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
10919451|NCT00659230|BG002|Baseline|Total|Total of all reporting groups
10919452|NCT00659230|FG000|Participant Flow|Placebo|"Arm 1~Placebo: 100-800mg placebo"
10919453|NCT00659230|FG001|Participant Flow|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
10919454|NCT00659230|OG000|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
10919455|NCT00659230|OG001|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
10919456|NCT00659230|EG000|Reported Event|Placebo|"Arm 1~Placebo: 100-800mg placebo"
10919457|NCT00659230|EG001|Reported Event|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
10919458|NCT00659269|BG000|Baseline|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
10919459|NCT00659269|BG001|Baseline|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
10919460|NCT00659269|BG002|Baseline|Total|Total of all reporting groups
10919461|NCT00659269|FG000|Participant Flow|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
10963199|NCT00870740|OG001|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
10919462|NCT00659269|FG001|Participant Flow|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
10919463|NCT00659269|OG000|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
10919464|NCT00659269|OG001|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400"
10919465|NCT00659269|OG002|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Cumulative doses for chemotherapy (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
10919466|NCT00659269|OG003|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
10919467|NCT00659269|OG004|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Cumulative doses for chemotherapy (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
10919468|NCT00659269|OG005|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
11174964|NCT02025985|OG002|Outcome|Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174965|NCT02025985|OG003|Outcome|Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11191881|NCT02134977|FG000|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
11357581|NCT03754582|BG000|Baseline|Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received maintenance dose of perampanel 8 to 12 mg, tablets, orally, once daily for 28 days (Day -28 to Day -1) in Pretreatment Phase followed by 8 to 12 mg maintenance dose of perampanel equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily from Day 1 to Day 4 in Treatment Phase, and then 8 to 12 mg maintenance dose of perampanel, tablets, orally, once daily from Day 5 to Day 11 (Follow-up Visit) in Follow-up Phase as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
10919469|NCT00659269|OG001|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
10919470|NCT00659269|OG002|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
10919471|NCT00659269|OG004|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
10919472|NCT00659269|OG001|Outcome|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
10919473|NCT00659269|OG000|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, abraxane, 1200-1800"
10919474|NCT00659269|EG000|Reported Event|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
10919475|NCT00659269|EG001|Reported Event|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
10919476|NCT00659295|BG000|Baseline|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
10919477|NCT00659295|BG001|Baseline|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
10919478|NCT00659295|BG002|Baseline|Total|Total of all reporting groups
10919479|NCT00659295|FG000|Participant Flow|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
10919480|NCT00659295|FG001|Participant Flow|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
10919481|NCT00659295|OG000|Outcome|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
11191330|NCT02131766|BG000|Baseline|USS Virginia Closed Loop Control vs SAP|"This is a cross-over trial in which each subject participates in two phases: USS Virginia Closed Loop Control (CLC) and Sensor Augmented Pump Therapy (SAP) and is randomized to order.~During CLC: The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The DiAs (CLC controller) will be initiated by 11:00 PM and will be discontinued before breakfast.~During SAP: The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods). The subject will follow their usual regimen.~A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission."
10919482|NCT00659295|OG001|Outcome|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
10919483|NCT00659295|EG000|Reported Event|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
10919484|NCT00659295|EG001|Reported Event|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
10919485|NCT00659334|BG000|Baseline|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
10919486|NCT00659334|BG001|Baseline|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
10919487|NCT00659334|BG002|Baseline|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
11234041|NCT02432040|BG000|Baseline|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
10919488|NCT00659334|BG003|Baseline|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
10919489|NCT00659334|BG004|Baseline|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
10919490|NCT00659334|BG005|Baseline|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
10919491|NCT00659334|BG006|Baseline|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
10919492|NCT00659334|BG007|Baseline|Total|Total of all reporting groups
10919493|NCT00659334|FG000|Participant Flow|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
10919494|NCT00659334|FG001|Participant Flow|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
10919495|NCT00659334|FG002|Participant Flow|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
10919496|NCT00659334|FG003|Participant Flow|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
10919497|NCT00659334|FG004|Participant Flow|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
10919498|NCT00659334|FG005|Participant Flow|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
10919499|NCT00659334|FG006|Participant Flow|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
10919500|NCT00659334|OG000|Outcome|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
10919501|NCT00659334|OG001|Outcome|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
11234042|NCT02432040|BG001|Baseline|Placebo|Placebo tablets But patients are still asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
10919502|NCT00659334|OG002|Outcome|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
10919503|NCT00659334|OG003|Outcome|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
10919504|NCT00659334|OG004|Outcome|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
10919505|NCT00659334|OG005|Outcome|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
10919506|NCT00659334|OG006|Outcome|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
10919507|NCT00659334|EG000|Reported Event|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
11234043|NCT02432040|BG002|Baseline|Total|Total of all reporting groups
11234044|NCT02432040|FG000|Participant Flow|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
10919508|NCT00659334|EG001|Reported Event|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
10919509|NCT00659334|EG002|Reported Event|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
10919510|NCT00659334|EG003|Reported Event|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
10919511|NCT00659334|EG004|Reported Event|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
10919512|NCT00659334|EG005|Reported Event|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
10919513|NCT00659334|EG006|Reported Event|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
10919514|NCT00659360|BG000|Baseline|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
10919515|NCT00659360|FG000|Participant Flow|Arm I AZD0530|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
10919516|NCT00659360|OG000|Outcome|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
10919517|NCT00659360|OG000|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
10919518|NCT00659360|OG000|Outcome|Arm I AZD0530|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
11234045|NCT02432040|FG001|Participant Flow|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
10919519|NCT00659360|EG000|Reported Event|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
10919520|NCT00659373|BG000|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
10919521|NCT00659373|BG001|Baseline|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation).~Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
10919522|NCT00659373|BG002|Baseline|Total|Total of all reporting groups
10919523|NCT00659373|FG000|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
10919524|NCT00659373|FG001|Participant Flow|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10919525|NCT00659373|OG000|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
10919526|NCT00659373|OG001|Outcome|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)~Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
10919527|NCT00659373|EG000|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
10919528|NCT00659373|EG001|Reported Event|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10919529|NCT00659425|BG000|Baseline|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919530|NCT00659425|BG001|Baseline|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919531|NCT00659425|BG002|Baseline|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919532|NCT00659425|BG003|Baseline|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919533|NCT00659425|BG004|Baseline|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919534|NCT00659425|BG005|Baseline|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919535|NCT00659425|BG006|Baseline|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919536|NCT00659425|BG007|Baseline|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919537|NCT00659425|BG008|Baseline|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919538|NCT00659425|BG009|Baseline|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919539|NCT00659425|BG010|Baseline|Total|Total of all reporting groups
10919540|NCT00659425|FG000|Participant Flow|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919541|NCT00659425|FG001|Participant Flow|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919542|NCT00659425|FG002|Participant Flow|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919543|NCT00659425|FG003|Participant Flow|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919544|NCT00659425|FG004|Participant Flow|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11234046|NCT02432040|OG000|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
11234047|NCT02432040|OG001|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
10919545|NCT00659425|FG005|Participant Flow|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919546|NCT00659425|FG006|Participant Flow|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919547|NCT00659425|FG007|Participant Flow|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919548|NCT00659425|FG008|Participant Flow|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919549|NCT00659425|FG009|Participant Flow|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919550|NCT00659425|OG000|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919551|NCT00659425|OG001|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11174966|NCT02025985|OG004|Outcome|Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174967|NCT02025985|OG001|Outcome|Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
10919552|NCT00659425|OG002|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
11174968|NCT02025985|OG002|Outcome|Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
10919553|NCT00659425|OG003|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919554|NCT00659425|OG004|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919555|NCT00659425|OG005|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919556|NCT00659425|OG006|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919557|NCT00659425|OG007|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919558|NCT00659425|OG008|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919559|NCT00659425|OG000|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919560|NCT00659425|OG001|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10963200|NCT00870740|EG000|Reported Event|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
10919561|NCT00659425|OG002|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919562|NCT00659425|OG003|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919563|NCT00659425|OG004|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919564|NCT00659425|OG005|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919565|NCT00659425|OG006|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919566|NCT00659425|OG007|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919567|NCT00659425|OG008|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919568|NCT00659425|OG009|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919569|NCT00659425|OG002|Outcome|20 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919570|NCT00659425|OG003|Outcome|30 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919571|NCT00659425|OG004|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919572|NCT00659425|OG006|Outcome|50 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919573|NCT00659425|EG000|Reported Event|5 UG/KG SCHEMA A|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919574|NCT00659425|EG001|Reported Event|10 UG/KG SCHEMA A|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919575|NCT00659425|EG002|Reported Event|20 UG/KG SCHEMA A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919576|NCT00659425|EG003|Reported Event|20 UG/KG SCHEMA B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919577|NCT00659425|EG004|Reported Event|30 UG/KG SCHEMA A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919578|NCT00659425|EG005|Reported Event|30 UG/KG SCHEMA B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919579|NCT00659425|EG006|Reported Event|40 UG/KG SCHEMA B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919580|NCT00659425|EG007|Reported Event|32 UG/KG SCHEMA C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919581|NCT00659425|EG008|Reported Event|50 UG/KG SCHEMA B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10919582|NCT00659425|EG009|Reported Event|50 UG/KG SCHEMA C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
10919583|NCT00659438|BG000|Baseline|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
10919584|NCT00659438|BG001|Baseline|Placebo|Bicalutamide 150mg + placebo
10919585|NCT00659438|BG002|Baseline|Total|Total of all reporting groups
11191882|NCT02134977|OG000|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
10919586|NCT00659438|FG000|Participant Flow|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
10919587|NCT00659438|FG001|Participant Flow|Placebo|Bicalutamide 150mg + placebo
10919588|NCT00659438|OG000|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
10919589|NCT00659438|OG001|Outcome|Placebo|Bicalutamide 150mg + placebo
10919590|NCT00659438|EG000|Reported Event|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
10919591|NCT00659438|EG001|Reported Event|Placebo|Bicalutamide 150mg + placebo
10919592|NCT00659490|BG000|Baseline|AZD1940|AZD1940 800ug given predose
10919593|NCT00659490|BG001|Baseline|Placebo|Placebo given pre-surgery
10919594|NCT00659490|BG002|Baseline|Naproxen|Naproxen 500mg given pre-surgery
10919595|NCT00659490|BG003|Baseline|Total|Total of all reporting groups
10919596|NCT00659490|FG000|Participant Flow|AZD1940|AZD1940 800ug given predose
10919597|NCT00659490|FG001|Participant Flow|Placebo|Placebo given pre-surgery
10919598|NCT00659490|FG002|Participant Flow|Naproxen|Naproxen 500mg given pre-surgery
10919599|NCT00659490|OG000|Outcome|AZD1940|AZD1940 800ug given predose
10919600|NCT00659490|OG001|Outcome|Placebo|Placebo given pre-surgery
10919601|NCT00659490|OG002|Outcome|Naproxen|Naproxen 500mg given pre-surgery
10919602|NCT00659490|EG000|Reported Event|AZD1940|AZD1940 800ug given predose
11191883|NCT02134977|EG000|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
11191884|NCT02135016|BG000|Baseline|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
11191885|NCT02135016|BG001|Baseline|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
10919603|NCT00659490|EG001|Reported Event|Placebo|Placebo given pre-surgery
10919604|NCT00659490|EG002|Reported Event|Naproxen|Naproxen 500mg given pre-surgery
10919605|NCT00659529|BG000|Baseline|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
10919606|NCT00659529|FG000|Participant Flow|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
10919607|NCT00659529|OG000|Outcome|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
10919608|NCT00659529|EG000|Reported Event|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
10919609|NCT00659581|BG000|Baseline|Telmisartan|
10919610|NCT00659581|FG000|Participant Flow|Telmisartan|
10919611|NCT00659581|OG000|Outcome|Telmisartan|
10919612|NCT00659581|EG000|Reported Event|Telmisartan|
10919613|NCT00659607|BG000|Baseline|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
10919614|NCT00659607|FG000|Participant Flow|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
10919615|NCT00659607|OG000|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
10919616|NCT00659607|OG000|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
10919617|NCT00659607|OG000|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
10919618|NCT00659607|EG000|Reported Event|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
10919619|NCT00659633|BG000|Baseline|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
10919620|NCT00659633|FG000|Participant Flow|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
10919621|NCT00659633|OG000|Outcome|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
10919622|NCT00659633|EG000|Reported Event|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
10919623|NCT00659724|BG000|Baseline|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
10919624|NCT00659724|FG000|Participant Flow|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
10919625|NCT00659724|OG000|Outcome|Revaclear MAX|
10919626|NCT00659724|OG001|Outcome|Optiflux F180NR|
10919627|NCT00659724|OG002|Outcome|Optiflux F200NR|
10919628|NCT00659724|EG000|Reported Event|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
10919629|NCT00659737|BG000|Baseline|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
11357582|NCT03754582|FG000|Participant Flow|Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day|Participants with partial onset-seizures (POS) with or without secondarily generalized seizures or primary generalized tonic clonic (PGTC) seizures received perampanel 8 milligram (mg) up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant antiepileptic drugs (AEDs). Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
10919630|NCT00659737|BG001|Baseline|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
10919631|NCT00659737|BG002|Baseline|Total|Total of all reporting groups
11191886|NCT02135016|BG002|Baseline|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
11357583|NCT03754582|FG001|Participant Flow|Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
11357584|NCT03754582|FG002|Participant Flow|Follow-up Phase: Oral Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
11357585|NCT03754582|OG000|Outcome|Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
11357586|NCT03754582|OG001|Outcome|Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
11357587|NCT03754582|OG002|Outcome|Follow-up Phase: Oral Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
11357588|NCT03754582|OG000|Outcome|Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
11357589|NCT03754582|OG001|Outcome|Follow-up Phase: Oral Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
11357590|NCT03754582|OG000|Outcome|Pretreatment Phase: Oral Perampanel 8 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
11357591|NCT03754582|OG001|Outcome|Pretreatment Phase: Oral Perampanel 10 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 10 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
11357592|NCT03754582|OG002|Outcome|Pretreatment Phase: Oral Perampanel 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
11357593|NCT03754582|OG003|Outcome|Treatment Phase: Intravenous Perampanel 8 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
11357594|NCT03754582|OG004|Outcome|Treatment Phase: Intravenous Perampanel 10 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
11357595|NCT03754582|OG005|Outcome|Treatment Phase: Intravenous Perampanel 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
11357596|NCT03754582|EG000|Reported Event|Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
10919632|NCT00659737|FG000|Participant Flow|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
10919633|NCT00659737|FG001|Participant Flow|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure.
10919634|NCT00659737|OG000|Outcome|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
10919635|NCT00659737|OG001|Outcome|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
10919636|NCT00659737|EG000|Reported Event|Aprepiatnt|"Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.~Emend (Aprepitant) + Placebo: 40mg tablet"
10919637|NCT00659737|EG001|Reported Event|Scopolamine|"Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.~Scopolamine + Emend (Aprepitant): 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days"
10919638|NCT00659789|BG000|Baseline|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
10919639|NCT00659789|BG001|Baseline|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
10919640|NCT00659789|BG002|Baseline|Total|Total of all reporting groups
10919641|NCT00659789|FG000|Participant Flow|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
10919642|NCT00659789|FG001|Participant Flow|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
10919643|NCT00659789|OG000|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
10919644|NCT00659789|OG001|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
10919645|NCT00659789|EG000|Reported Event|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
10919646|NCT00659789|EG001|Reported Event|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
10919647|NCT00659802|BG000|Baseline|High Dose HMPL-004 (1800 mg/Day)|HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.
10919648|NCT00659802|BG001|Baseline|Low Dose HMPL-004 (1200 mg/Day)|HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
10919649|NCT00659802|BG002|Baseline|Placebo|Placebo, t.i.d.
10919650|NCT00659802|BG003|Baseline|Total|Total of all reporting groups
10919651|NCT00659802|FG000|Participant Flow|High Dose HMPL-004 (1800 mg/Day)|HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.
10919652|NCT00659802|FG001|Participant Flow|Low Dose HMPL-004 (1200 mg/Day)|HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
10919653|NCT00659802|FG002|Participant Flow|Placebo|Placebo, t.i.d.
11191887|NCT02135016|BG003|Baseline|Total|Total of all reporting groups
11191888|NCT02135016|FG000|Participant Flow|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
10919654|NCT00659802|OG000|Outcome|Low Dose HMPL-004 (1200 mg/Day)|HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
10919655|NCT00659802|OG001|Outcome|High Dose HMPL-004 (1800 mg/Day)|HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.
10919656|NCT00659802|OG002|Outcome|Placebo|Placebo, t.i.d.
10919657|NCT00659802|EG000|Reported Event|Low Dose HMPL-004 (1200 mg/Day)|HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
10919658|NCT00659802|EG001|Reported Event|High Dose HMPL-004 (1800 mg/Day)|HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.
10919659|NCT00659802|EG002|Reported Event|Placebo|Placebo, t.i.d.
10919660|NCT00659815|BG000|Baseline|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
10919661|NCT00659815|BG001|Baseline|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
10919662|NCT00659815|BG002|Baseline|Total|Total of all reporting groups
10919663|NCT00659815|FG000|Participant Flow|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
10919664|NCT00659815|FG001|Participant Flow|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
10919665|NCT00659815|OG000|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
10919666|NCT00659815|OG001|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
10919667|NCT00659815|EG000|Reported Event|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
10919668|NCT00659815|EG001|Reported Event|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
10919669|NCT00659828|BG000|Baseline|Recombinant Methionyl Human Leptin|Recombinant methionyl human leptin: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss).
10963201|NCT00870740|EG001|Reported Event|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
10919670|NCT00659828|FG000|Participant Flow|Recombinant Methionyl Human Leptin|Recombinant methionyl human leptin: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss).
10919671|NCT00659828|OG000|Outcome|Recombinant Methionyl Human Leptin|Recombinant methionyl human leptin: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss).
10919672|NCT00659828|EG000|Reported Event|Recombinant Methionyl Human Leptin|Recombinant methionyl human leptin: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss).
10919673|NCT00659880|BG000|Baseline|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
10919674|NCT00659880|FG000|Participant Flow|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
10919675|NCT00659880|OG000|Outcome|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
10919676|NCT00659880|OG000|Outcome|Meniscal Allograft Integration|The MRI were assessed for the integration of the posterior and anterior horns as well as the body of the meniscus.
10919677|NCT00659880|EG000|Reported Event|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
10919678|NCT00659945|BG000|Baseline|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
10919679|NCT00659945|BG001|Baseline|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
11191889|NCT02135016|FG001|Participant Flow|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
10919680|NCT00659945|BG002|Baseline|Total|Total of all reporting groups
10919681|NCT00659945|FG000|Participant Flow|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
10919682|NCT00659945|FG001|Participant Flow|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
10919683|NCT00659945|OG000|Outcome|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
10919684|NCT00659945|OG001|Outcome|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
10919685|NCT00659945|EG000|Reported Event|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
10919686|NCT00659945|EG001|Reported Event|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
10919687|NCT00659984|BG000|Baseline|Ultratrace™ Iobenguane I 131|Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Therapeutic dosing began at 12.0 mCi/kg and escalated to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.
10919688|NCT00659984|FG000|Participant Flow|Ultratrace™ Iobenguane I 131|"Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 within 7 days (d) of enrollment, followed by 3 dosimetry scans over 3-6 days. For the imaging dose, 0.1 mCi/kg (3.7 MBq/kg), at a min dose of 1 mCi (37 MBq) but not to exceed 5 mCi (185 MBq) of Ultratrace™ Iobenguane I 131 was administered 7-28 d prior to the therapeutic dose on Day 0. If the imaging dose demonstrated NL biodistribution/tumor uptake, pts received a therapeutic dose within 7-28 d of the imaging dose followed by a single imaging scan on Day 7 post therapy.~Therapeutic dosing was to begin at 12.0 mCi/kg and escalate to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. Based on actual doses administered, pts were grouped into 3 mean dose groups: 11.2, 15.5, and 18.2 mCi/kg.~The dosimetry dose was administered over 1-3 mins by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused over 30 to 60 mins."
10919689|NCT00659984|OG000|Outcome|Ultratrace™ Iobenguane I 131|Following therapeutic dosing at the 12.0, 15.0, and 18.0 mCi/kg cohorts, 4 patients who were to receive the 21.0 mCi/kg therapeutic dose were required to have their planned dose reduced below the dose that was calculated based on the patient's dosimetry results, in order to meet the protocol guidelines for maximal dosage allowed to normal organs described above. Because of the differences between the planned and actual therapeutic doses that were administered to several patients, patients were grouped and the study data were presented and analyzed by actual doses rather than by the planned dose cohorts of 12.0, 15.0, 18.0, and 21.0 mCi/kg. Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
10919690|NCT00659984|OG000|Outcome|11.2 mCi Group|11.2 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
10919691|NCT00659984|OG001|Outcome|15.5 mCi Group|15.5 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
10919692|NCT00659984|OG002|Outcome|18.2 mCi Group|18.2 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
10919693|NCT00659984|OG000|Outcome|Ultratrace™ Iobenguane I 131|The proportion of patients who were considered successful defined as a patient achieving a Complete Response, Very Good Partial Response or Partial Response as determined by the Independent Reviewers.
10919694|NCT00659984|OG000|Outcome|Over Tumor Response|The proportion of patients who were considered successful defined as a patient achieving a Complete Response, Very Good Partial Response or Partial Response as determined by the Independent Reviewers.
10919695|NCT00659984|OG000|Outcome|Ultratrace™ Iobenguane I 131|Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
10963202|NCT00870740|EG002|Reported Event|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
11191890|NCT02135016|FG002|Participant Flow|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
11191891|NCT02135016|OG000|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
10919696|NCT00659984|EG000|Reported Event|Ultratrace™ Iobenguane I 131|Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Mean therapeutic dosing groups were 11.2 mCi/kg, 15.5 nCi/kg and 18.2 mCi/kg. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.
10919697|NCT00660010|BG000|Baseline|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
10919698|NCT00660010|FG000|Participant Flow|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
10919699|NCT00660010|OG000|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
10919700|NCT00660010|EG000|Reported Event|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
10919701|NCT00660023|BG000|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
10919702|NCT00660023|FG000|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.0 and 12.0 grams per deciliter (g/dL).
10919703|NCT00660023|OG000|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
10919704|NCT00660023|EG000|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
10919705|NCT00660049|BG000|Baseline|Open Label Single Arm Study|Eligible participants
10919706|NCT00660049|FG000|Participant Flow|SNaP Application|"This is an open label pilot study of SMart Negative Pressure (SNaP) Advanced Wound Care System~SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions~SNaP: Daily use~SNaP: Daily application per protocol"
10919707|NCT00660049|OG000|Outcome|Open Label Single Arm Study|All participants who use the device
10919708|NCT00660049|EG000|Reported Event|Eligible Participants|"This is an open label pilot study of SNaP Advanced Wound Care System~SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions~SNaP: Daily use~SNaP: Daily application per protocol"
10919709|NCT00660075|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
10919710|NCT00660075|BG001|Baseline|Placebo|Placebo for 6 weeks
10919711|NCT00660075|BG002|Baseline|Total|Total of all reporting groups
10919712|NCT00660075|FG000|Participant Flow|Placebo First, Then Sitagliptin|Participants were first administered placebo for 6 weeks followed by a washout period of 4 weeks and were then switched over to Sitagliptin 100 mg/d for 6 weeks.
10919713|NCT00660075|FG001|Participant Flow|Sitagliptin First, Then Placebo|Participants were first administered Sitagliptin 100 mg/d for 6 weeks followed by a washout period of 4 weeks and were then switched over to placebo for 6 weeks.
10919714|NCT00660075|OG000|Outcome|Placebo|Placebo for 6 weeks
10919715|NCT00660075|OG001|Outcome|Sitagliptin 100 mg/d|Sitagliptin 100 mg/d for 6 weeks
10919716|NCT00660075|EG000|Reported Event|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
10919717|NCT00660075|EG001|Reported Event|Placebo|Placebo for 6 weeks
10919718|NCT00660179|BG000|Baseline|Placebo|Matching ACT-064992 placebo tablet, once daily
10919719|NCT00660179|BG001|Baseline|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
10919720|NCT00660179|BG002|Baseline|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
10919721|NCT00660179|BG003|Baseline|Total|Total of all reporting groups
10919722|NCT00660179|FG000|Participant Flow|Placebo|Matching ACT-064992 placebo tablet, once daily
10919723|NCT00660179|FG001|Participant Flow|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
10919724|NCT00660179|FG002|Participant Flow|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
10919725|NCT00660179|OG000|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
10919726|NCT00660179|OG001|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
10919727|NCT00660179|OG002|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
10919728|NCT00660179|EG000|Reported Event|Placebo|Matching ACT-064992 placebo tablet, once daily
10919729|NCT00660179|EG001|Reported Event|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
10919730|NCT00660179|EG002|Reported Event|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
10919731|NCT00660192|BG000|Baseline|Placebo|
10919732|NCT00660192|BG001|Baseline|Botox|
10919733|NCT00660192|BG002|Baseline|Total|Total of all reporting groups
10919734|NCT00660192|FG000|Participant Flow|Placebo|Subjects randomized to placebo ho receive injections of 2cc's to 3cc's of saline solution. into muscle of the scalp and neck.
10919735|NCT00660192|FG001|Participant Flow|Botox|Subjects randomized to receive 200-300units of onobotulinumtoxinA by injections into the scalp and neck muscles
10919736|NCT00660192|OG000|Outcome|Placebo|Inactive Saline
10919737|NCT00660192|OG001|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
10919738|NCT00660192|EG000|Reported Event|Saline|
10919739|NCT00660192|EG001|Reported Event|Botox|
10919740|NCT00660309|BG000|Baseline|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
10919741|NCT00660309|BG001|Baseline|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
10919742|NCT00660309|BG002|Baseline|Total|Total of all reporting groups
11191892|NCT02135016|OG001|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
10919743|NCT00660309|FG000|Participant Flow|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
10919744|NCT00660309|FG001|Participant Flow|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
10919745|NCT00660309|OG000|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
10919746|NCT00660309|OG001|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
10919747|NCT00660309|EG000|Reported Event|Captopril 25 mg|On Day 1 participants received a single oral dose of 25 mg captopril.
10919748|NCT00660309|EG001|Reported Event|Aliskiren 300 mg|Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
10919749|NCT00660309|EG002|Reported Event|Irbesartan 300 mg|Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
10919750|NCT00660387|BG000|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
10919751|NCT00660387|BG001|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
10919752|NCT00660387|BG002|Baseline|Total|Total of all reporting groups
10919753|NCT00660387|FG000|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
10919754|NCT00660387|FG001|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
10919755|NCT00660387|OG000|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
10919756|NCT00660387|OG001|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
10919757|NCT00660387|EG000|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
10919758|NCT00660387|EG001|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
10919759|NCT00660400|BG000|Baseline|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
10919760|NCT00660400|FG000|Participant Flow|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
10919761|NCT00660400|OG000|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
10919762|NCT00660400|EG000|Reported Event|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
10919763|NCT00660504|BG000|Baseline|Amrubicin, Anticancer, Injection|
10919764|NCT00660504|BG001|Baseline|Etoposide, Anticancer, Injection|
10919765|NCT00660504|BG002|Baseline|Total|Total of all reporting groups
10919766|NCT00660504|FG000|Participant Flow|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
10919767|NCT00660504|FG001|Participant Flow|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
10919768|NCT00660504|OG000|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
10919769|NCT00660504|OG001|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
10919770|NCT00660504|EG000|Reported Event|Amrubicin, Anticancer, Injection|
10919771|NCT00660504|EG001|Reported Event|Etoposide, Anticancer, Injection|
10919772|NCT00660517|BG000|Baseline|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
10919773|NCT00660517|BG001|Baseline|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
10919774|NCT00660517|BG002|Baseline|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
10919775|NCT00660517|BG003|Baseline|Placebo|nasal spray
10919776|NCT00660517|BG004|Baseline|Total|Total of all reporting groups
10919777|NCT00660517|FG000|Participant Flow|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
10919778|NCT00660517|FG001|Participant Flow|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
11357597|NCT03754582|EG001|Reported Event|Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
10919779|NCT00660517|FG002|Participant Flow|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
10919780|NCT00660517|FG003|Participant Flow|Placebo|nasal spray
10919781|NCT00660517|OG000|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
10919782|NCT00660517|OG001|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
10919783|NCT00660517|OG002|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
10919784|NCT00660517|OG003|Outcome|Placebo|nasal spray
10919785|NCT00660517|OG003|Outcome|Placebo|placebo nasal spray one spray per nostril two times a day
10919786|NCT00660517|EG000|Reported Event|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
10919787|NCT00660517|EG001|Reported Event|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
10919788|NCT00660517|EG002|Reported Event|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
10919789|NCT00660517|EG003|Reported Event|Placebo|nasal spray
10919790|NCT00660530|BG000|Baseline|Chewed or Crushed Lanthanum Carbonate|Lanthanum carbonate 1 g to be chewed or crushed, three times daily with meals
10919791|NCT00660530|FG000|Participant Flow|Chewed or Crushed Lanthanum Carbonate|Lanthanum carbonate 1 g to be chewed or crushed, three times daily with meals, after 1-week washout period, then Lanthanum carbonate 1 g to be chewed crushed, three times daily with meals (the treatment that the subject did not receive in the initial treatment).
10919792|NCT00660530|OG000|Outcome|Chewed Lanthanum Carbonate|Lanthanum carbonate 1 g to be chewed, three times daily with meals
10919793|NCT00660530|OG001|Outcome|Crushed Lanthanum Carbonate|"Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal~Lanthanum carbonate: Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal"
10919794|NCT00660530|EG000|Reported Event|Chewed Lanthanum Carbonate|Lanthanum carbonate 1 g to be chewed, three times daily with meals
10919795|NCT00660530|EG001|Reported Event|Crushed Lanthanum Carbonate|Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal
10919796|NCT00660543|BG000|Baseline|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
10919797|NCT00660543|FG000|Participant Flow|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
10919798|NCT00660543|OG000|Outcome|Ferumoxytol|Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
10919799|NCT00660543|OG001|Outcome|Gadoteridol|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
10919800|NCT00660543|OG002|Outcome|Gadoteridol Leakage Correction|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
10919801|NCT00660543|OG000|Outcome|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).
10919802|NCT00660543|EG000|Reported Event|Ferumoxytol|Subjects all received ferumoxytol enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
10919803|NCT00660543|EG001|Reported Event|Gadoteridol|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
11357598|NCT03754582|EG002|Reported Event|Follow-up Phase: Oral Perampanel 8 to 12 mg/Day|Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
10919804|NCT00660543|EG002|Reported Event|Gadoteridol With Leakage Correction|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
10919805|NCT00660660|BG000|Baseline|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
10919806|NCT00660660|BG001|Baseline|Placebo|Capsule once daily (QD)
10919807|NCT00660660|BG002|Baseline|Total|Total of all reporting groups
10919808|NCT00660660|FG000|Participant Flow|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
10919809|NCT00660660|FG001|Participant Flow|Placebo|Capsule once daily (QD)
10919810|NCT00660660|OG000|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
10919811|NCT00660660|OG001|Outcome|Placebo|Capsule once daily (QD)
10919812|NCT00660660|EG000|Reported Event|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
11191893|NCT02135016|OG002|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
10919813|NCT00660660|EG001|Reported Event|Placebo|Capsule once daily (QD)
10919814|NCT00660699|BG000|Baseline|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
10919815|NCT00660699|FG000|Participant Flow|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
10919816|NCT00660699|OG000|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
10919817|NCT00660699|EG000|Reported Event|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
10919818|NCT00660790|BG000|Baseline|Patients With Type 2 Diabetes|"patients with type 2 diabetes~Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines"
10919819|NCT00660790|FG000|Participant Flow|Patients With Type 2 Diabetes|"diabetic subjects, above targets~Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines"
10919820|NCT00660790|OG000|Outcome|Patients With Type 2 Diabetes|"diabetic subjects, above targets~Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines"
11234048|NCT02432040|EG000|Reported Event|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
10919821|NCT00660790|EG000|Reported Event|Patients With Type 2 Diabetes|"diabetic subjects, above targets~Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines"
10919822|NCT00660816|BG000|Baseline|Active Comparator|Alimta or Taxotere alone
10919823|NCT00660816|BG001|Baseline|Experimental|Alimta or Taxotere and Tarceva
10919824|NCT00660816|BG002|Baseline|Total|Total of all reporting groups
10919825|NCT00660816|FG000|Participant Flow|Active Comparator|Alimta or Taxotere alone
10919826|NCT00660816|FG001|Participant Flow|Experimental|Alimta or Taxotere and Tarceva
10919827|NCT00660816|OG000|Outcome|Active Comparator|Alimta or Taxotere alone
10919828|NCT00660816|OG001|Outcome|Experimental|Alimta or Taxotere and Tarceva
10919829|NCT00660816|EG000|Reported Event|Active Comparator|Alimta or Taxotere alone
10919830|NCT00660816|EG001|Reported Event|Experimental|Alimta or Taxotere and Tarceva
10919831|NCT00660829|BG000|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
10919832|NCT00660829|BG001|Baseline|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
10919833|NCT00660829|BG002|Baseline|Total|Total of all reporting groups
10919834|NCT00660829|FG000|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
10919835|NCT00660829|FG001|Participant Flow|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
11191894|NCT02135016|EG000|Reported Event|Group A|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
11191895|NCT02135016|EG001|Reported Event|Group B|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
11191896|NCT02135016|EG002|Reported Event|Group C|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
11234049|NCT02432040|EG001|Reported Event|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
10919836|NCT00660829|OG000|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
10919837|NCT00660829|OG001|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
10919838|NCT00660829|EG000|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
10919839|NCT00660829|EG001|Reported Event|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
10919840|NCT00660907|BG000|Baseline|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
10919841|NCT00660907|BG001|Baseline|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
10919842|NCT00660907|BG002|Baseline|Total|Total of all reporting groups
10919843|NCT00660907|FG000|Participant Flow|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
11174969|NCT02025985|EG000|Reported Event|Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11191897|NCT02135094|BG000|Baseline|Active Ultrasound Therapy Device|"Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity~Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day"
10919844|NCT00660907|FG001|Participant Flow|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
11234050|NCT02432105|BG000|Baseline|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
10919845|NCT00660907|OG000|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
10919846|NCT00660907|OG001|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
10919847|NCT00660907|EG000|Reported Event|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
10919848|NCT00660907|EG001|Reported Event|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
10919849|NCT00660985|BG000|Baseline|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
10919850|NCT00660985|BG001|Baseline|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
10919851|NCT00660985|BG002|Baseline|Total|Total of all reporting groups
10919852|NCT00660985|FG000|Participant Flow|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
10919853|NCT00660985|FG001|Participant Flow|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
10919854|NCT00660985|OG000|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
10919855|NCT00660985|OG001|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
10919856|NCT00660985|EG000|Reported Event|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
10919857|NCT00660985|EG001|Reported Event|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
10919858|NCT00661037|BG000|Baseline|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
10919859|NCT00661037|BG001|Baseline|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
10919860|NCT00661037|BG002|Baseline|Total|Total of all reporting groups
10919861|NCT00661037|FG000|Participant Flow|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
10919862|NCT00661037|FG001|Participant Flow|no VF Induction|"Patients not having VF induction at implant or during follow-up~Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock."
10919863|NCT00661037|OG000|Outcome|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
10919864|NCT00661037|OG001|Outcome|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
10919865|NCT00661037|OG000|Outcome|VF Induction|Patients having VF induction with shock termination at implant
10919866|NCT00661037|OG001|Outcome|No- VF Induction|Patients not having VF induction at implant or during follow-up
10919867|NCT00661037|EG000|Reported Event|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
10919868|NCT00661037|EG001|Reported Event|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
10919869|NCT00661089|BG000|Baseline|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
10919870|NCT00661089|BG001|Baseline|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
10919871|NCT00661089|BG002|Baseline|Total|Total of all reporting groups
10919872|NCT00661089|FG000|Participant Flow|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
10919873|NCT00661089|FG001|Participant Flow|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
10919874|NCT00661089|OG000|Outcome|Placebo|Group recieved saline injections intramuscularly of equivalent volume
10919875|NCT00661089|OG001|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
10919876|NCT00661089|OG000|Outcome|Placebo|Group received saline injections intramuscularly of equivalent volume
10919877|NCT00661089|EG000|Reported Event|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
10919878|NCT00661089|EG001|Reported Event|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
10919879|NCT00661141|BG000|Baseline|Antizol 1.0 mg/kg and Placebo|Participants received alternating study treatment (oral Antizol 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919880|NCT00661141|BG001|Baseline|Antizol 3.0 mg/kg and Placebo|Participants receive alternating study treatment (oral Antizol 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919881|NCT00661141|BG002|Baseline|Antizol 5.0 mg/kg and Placebo|Participants receive alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919882|NCT00661141|BG003|Baseline|Total|Total of all reporting groups
10919883|NCT00661141|FG000|Participant Flow|Antizol 1.0 mg/kg, Then Placebo|Participants received Antizol 1.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919884|NCT00661141|FG001|Participant Flow|Placebo, Then Antizol 1.0 mg/kg|Participants received placebo treatment then Antizol 1.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919885|NCT00661141|FG002|Participant Flow|Antizol 3.0 mg/kg, Then Placebo|Participants received Antizol 3.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919886|NCT00661141|FG003|Participant Flow|Placebo, Then Antizol 3.0 mg/kg|Participants received placebo treatment then Antizol 3.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919887|NCT00661141|FG004|Participant Flow|Antizol 5.0 mg/kg, Then Placebo|Participants received Antizol 5.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
10919888|NCT00661141|FG005|Participant Flow|Placebo, Then Antizol 5.0 mg/kg|Participants received placebo treatment then Antizol 5.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
10919889|NCT00661141|OG000|Outcome|Antizol 1.0 mg/kg|Participants received alternating study treatment (oral Antizol 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919890|NCT00661141|OG001|Outcome|Antizol 3.0 mg/kg|Participants received alternating study treatment (oral Antizol 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919891|NCT00661141|OG002|Outcome|Antizol 5.0 mg/kg|Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
10919892|NCT00661141|OG003|Outcome|Pooled Placebo|Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.
10919893|NCT00661141|OG004|Outcome|Overall|Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
10919894|NCT00661141|OG000|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
10919895|NCT00661141|OG001|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
10919896|NCT00661141|OG002|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
10919897|NCT00661141|OG003|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
11234051|NCT02432105|BG001|Baseline|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
10919898|NCT00661141|OG004|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
10919899|NCT00661141|OG005|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
10919900|NCT00661141|OG006|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
10919901|NCT00661141|EG000|Reported Event|Antizol 1.0 mg/kg|Participants received alternating study treatment (oral Antizol 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919902|NCT00661141|EG001|Reported Event|Antizol 3.0 mg/kg|Participants received alternating study treatment (oral Antizol 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
10919903|NCT00661141|EG002|Reported Event|Antizol 5.0 mg/kg|Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
10919904|NCT00661141|EG003|Reported Event|Pooled Placebo|Participants received placebo on either Study Day 1 or Study Day 2), administered 30 minutes prior to ethanol.
10919905|NCT00661141|EG004|Reported Event|Overall|Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
10919906|NCT00661193|BG000|Baseline|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10919907|NCT00661193|BG001|Baseline|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10919908|NCT00661193|BG002|Baseline|Total|Total of all reporting groups
11234052|NCT02432105|BG002|Baseline|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
11234053|NCT02432105|BG003|Baseline|Total|Total of all reporting groups
10919909|NCT00661193|FG000|Participant Flow|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10919910|NCT00661193|FG001|Participant Flow|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10919911|NCT00661193|OG000|Outcome|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10919912|NCT00661193|OG001|Outcome|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10919913|NCT00661193|EG000|Reported Event|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10919914|NCT00661193|EG001|Reported Event|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10919915|NCT00661258|BG000|Baseline|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
10919916|NCT00661258|BG001|Baseline|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
10919917|NCT00661258|BG002|Baseline|Total|Total of all reporting groups
10919918|NCT00661258|FG000|Participant Flow|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
10919919|NCT00661258|FG001|Participant Flow|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
10919920|NCT00661258|OG000|Outcome|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
10919921|NCT00661258|OG001|Outcome|Control|The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for
10919922|NCT00661258|EG000|Reported Event|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
10919923|NCT00661258|EG001|Reported Event|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
10919924|NCT00661271|BG000|Baseline|MBSR Program|"mindfulness-based stress reduction program~Mindfulness-based stress reduction (MBSR): 8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session."
10919925|NCT00661271|BG001|Baseline|HT Program|"Health education program.~Healthy topics (HT): 8-week health education program with one retreat session"
10919926|NCT00661271|BG002|Baseline|Total|Total of all reporting groups
10919927|NCT00661271|FG000|Participant Flow|MBSR Program|"mindfulness-based stress reduction program~Mindfulness-based stress reduction (MBSR): 8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session."
11191898|NCT02135094|BG001|Baseline|Placebo Ultrasound Therapy Device|"Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound."
10919928|NCT00661271|FG001|Participant Flow|HT Program|"Health education program.~Healthy topics: 8-week health education program with one retreat session"
10919929|NCT00661271|OG000|Outcome|MBSR Program|"8 week mindfulness-based stress reduction program~Mindfulness-based stress reduction (MBSR): 8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice."
10919930|NCT00661271|OG001|Outcome|HT Program|"Health education group--8 weekly sessions of age-appropriate health topics.~Healthy topics (HT): 8 week health education program"
10919931|NCT00661271|EG000|Reported Event|MBSR Program|"mindfulness-based stress reduction program~Mindfulness-based stress reduction (MBSR): 9 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice."
10919932|NCT00661271|EG001|Reported Event|HT Program|"Health education program~Healthy topics: 9 week health education program"
10919933|NCT00661362|BG000|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
10919934|NCT00661362|BG001|Baseline|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
10919935|NCT00661362|BG002|Baseline|Total|Total of all reporting groups
10919936|NCT00661362|FG000|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
10919937|NCT00661362|FG001|Participant Flow|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
10919938|NCT00661362|OG000|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
10919939|NCT00661362|OG001|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
10919940|NCT00661362|EG000|Reported Event|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
10919941|NCT00661362|EG001|Reported Event|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
10919942|NCT00661388|BG000|Baseline|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
10919943|NCT00661388|FG000|Participant Flow|C.E.R.A|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A) subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 micrograms (mcg)/kilogram (kg). Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) within the target range of 10.0 and 12.0 grams (g)/ deciliter (dL).
10919944|NCT00661388|OG000|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
10919945|NCT00661388|EG000|Reported Event|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
10919946|NCT00661427|BG000|Baseline|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
10919947|NCT00661427|BG001|Baseline|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
10919948|NCT00661427|BG002|Baseline|Total|Total of all reporting groups
10919949|NCT00661427|FG000|Participant Flow|Cetuximab Infusion at 500 mg/m^2|Cetuximab infusion at 500 mg/m^2 over 2 hours every other week.
10919950|NCT00661427|FG001|Participant Flow|Cetuximab Infusion at 750 mg/m^2|Cetuximab infusion at 750 mg/m^2 over 3 hours every other week.
10919951|NCT00661427|OG000|Outcome|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
10919952|NCT00661427|OG001|Outcome|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
11191899|NCT02135094|BG002|Baseline|Total|Total of all reporting groups
11191900|NCT02135094|FG000|Participant Flow|Active Ultrasound Therapy Device|"Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity~Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day"
10919953|NCT00661427|EG000|Reported Event|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
10919954|NCT00661427|EG001|Reported Event|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
10919955|NCT00661453|BG000|Baseline|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
10919956|NCT00661453|FG000|Participant Flow|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
10919957|NCT00661453|OG000|Outcome|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
10919958|NCT00661453|EG000|Reported Event|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
10919959|NCT00661479|BG000|Baseline|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919960|NCT00661479|BG001|Baseline|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919961|NCT00661479|BG002|Baseline|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919962|NCT00661479|BG003|Baseline|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919963|NCT00661479|BG004|Baseline|Total|Total of all reporting groups
10919964|NCT00661479|FG000|Participant Flow|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919965|NCT00661479|FG001|Participant Flow|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919966|NCT00661479|FG002|Participant Flow|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919967|NCT00661479|FG003|Participant Flow|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919968|NCT00661479|OG000|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919969|NCT00661479|OG001|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919970|NCT00661479|OG002|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919971|NCT00661479|OG003|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919972|NCT00661479|EG000|Reported Event|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919973|NCT00661479|EG001|Reported Event|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919974|NCT00661479|EG002|Reported Event|100 µg Brimonidine Tartrate Implant Groups A and B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
10919975|NCT00661492|BG000|Baseline|Arm 1|Novantrone+Erbitux
10919976|NCT00661492|BG001|Baseline|Arm 2|Novantrone
10919977|NCT00661492|BG002|Baseline|Total|Total of all reporting groups
10919978|NCT00661492|FG000|Participant Flow|Arm 1|Novantrone+Erbitux
10919979|NCT00661492|FG001|Participant Flow|Arm 2|Novantrone
10919980|NCT00661492|OG000|Outcome|Arm 1|Novantrone+Erbitux
10919981|NCT00661492|OG001|Outcome|Arm 2|Novantrone
10919982|NCT00661492|EG000|Reported Event|Arm 1|Novantrone+Erbitux
10919983|NCT00661492|EG001|Reported Event|Arm 2|Novantrone
10919984|NCT00661505|BG000|Baseline|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
10919985|NCT00661505|FG000|Participant Flow|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
10919986|NCT00661505|OG000|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
10919987|NCT00661505|OG000|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
10919988|NCT00661505|EG000|Reported Event|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
10919989|NCT00661531|BG000|Baseline|Estrace & Anastrozole|Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
10919990|NCT00661531|FG000|Participant Flow|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
10919991|NCT00661531|OG000|Outcome|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
10963203|NCT00870740|EG003|Reported Event|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
10919992|NCT00661531|EG000|Reported Event|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
10919993|NCT00661544|BG000|Baseline|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
10919994|NCT00661544|FG000|Participant Flow|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
10919995|NCT00661544|OG000|Outcome|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
10919996|NCT00661544|EG000|Reported Event|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
10919997|NCT00661557|BG000|Baseline|Mencevax Primed Group|Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
10919998|NCT00661557|BG001|Baseline|Mencevax Naive Group|Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
11174970|NCT02025985|EG001|Reported Event|Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174971|NCT02025985|EG002|Reported Event|Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW|Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
10919999|NCT00661557|BG002|Baseline|Total|Total of all reporting groups
10920000|NCT00661557|FG000|Participant Flow|Mencevax Primed Group|Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
10920001|NCT00661557|FG001|Participant Flow|Mencevax Naive Group|Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
10920002|NCT00661557|OG000|Outcome|Mencevax Primed Group|Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
10920003|NCT00661557|OG001|Outcome|Mencevax Naive Group|Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
10920004|NCT00661557|EG000|Reported Event|Mencevax Primed Group|Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
10920005|NCT00661557|EG001|Reported Event|Mencevax Naive Group|Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
10920006|NCT00661570|BG000|Baseline|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
10920007|NCT00661570|FG000|Participant Flow|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
10920008|NCT00661570|OG000|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
10920009|NCT00661570|EG000|Reported Event|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
10920010|NCT00661583|BG000|Baseline|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
10920011|NCT00661583|BG001|Baseline|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
10920012|NCT00661583|BG002|Baseline|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
10920013|NCT00661583|BG003|Baseline|Total|Total of all reporting groups
11174972|NCT02025985|EG003|Reported Event|Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174973|NCT02025985|EG004|Reported Event|Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW|Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
11174974|NCT02026011|BG000|Baseline|Asn40Asn Genotype|Group that is homozygotes for the Asn40 allele
10920014|NCT00661583|FG000|Participant Flow|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
10920015|NCT00661583|FG001|Participant Flow|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
10920016|NCT00661583|FG002|Participant Flow|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
10920017|NCT00661583|OG000|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
10920018|NCT00661583|OG001|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
10920019|NCT00661583|OG002|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
10920020|NCT00661583|EG000|Reported Event|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
10920021|NCT00661583|EG001|Reported Event|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
10920022|NCT00661583|EG002|Reported Event|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
10920023|NCT00661609|BG000|Baseline|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
10920024|NCT00661609|FG000|Participant Flow|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
11174975|NCT02026011|BG001|Baseline|Asn40asp/Asp40Asp Genotype|Group that is a carrier of the Asp40 allele
11174976|NCT02026011|BG002|Baseline|Total|Total of all reporting groups
11174977|NCT02026011|FG000|Participant Flow|Allocated to Naltrexone|Group that was randomly assigned to receive Naltrexone first.
11174978|NCT02026011|FG001|Participant Flow|Allocated to Placebo|Group that was randomly assigned to receive Placebo first
11174979|NCT02026011|OG000|Outcome|Naltrexone - Asn40Asn|Group that was randomized to receive Naltrexone (50 mg/d) and is homozygote for the Asn40 allele.
10920025|NCT00661609|OG000|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
10920026|NCT00661609|EG000|Reported Event|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
10920027|NCT00661622|BG000|Baseline|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
10920028|NCT00661622|BG001|Baseline|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
10920029|NCT00661622|BG002|Baseline|Total|Total of all reporting groups
10920030|NCT00661622|FG000|Participant Flow|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
10920031|NCT00661622|FG001|Participant Flow|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
10920032|NCT00661622|OG000|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
10920033|NCT00661622|OG001|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
10920034|NCT00661622|OG001|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
10920035|NCT00661622|EG000|Reported Event|Immunoembolization|Liver embolization treatment with injection of GM-CSF.
10920036|NCT00661622|EG001|Reported Event|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
10920037|NCT00661661|BG000|Baseline|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
10920038|NCT00661661|BG001|Baseline|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
10920039|NCT00661661|BG002|Baseline|Total|Total of all reporting groups
10920040|NCT00661661|FG000|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
10920041|NCT00661661|FG001|Participant Flow|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
10920042|NCT00661661|OG000|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
10920043|NCT00661661|OG001|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
10920044|NCT00661661|OG002|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
10920045|NCT00661661|EG000|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
11174980|NCT02026011|OG001|Outcome|Naltrexone - Asn40Asp/Asp40Asp|Group that was randomized to receive Naltrexone (50mg/d) and carries at least one copy of the Asp40 allele.
11174981|NCT02026011|OG002|Outcome|Placebo - Asn40Asn|The group that was randomized to receive placebo and is homozygote for the Asn40 allele.
11174982|NCT02026011|OG003|Outcome|Placebo - Asn40Asp/Asp40Asp|Group that was randomized to receive Placebo and carries at least one copy of the Asp40 allele.
11174983|NCT02026011|OG002|Outcome|Placebo - Asn40Asn|The group that was randomized to receive placebo first and is homozygote for the Asn40 allele.
11174984|NCT02026011|EG000|Reported Event|Naltrexone|"Naltrexone 50 mg/day~Naltrexone: Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors"
11174985|NCT02026011|EG001|Reported Event|Sugar Pill|"Matched placebo~Placebo: Sugar pill, matched to the active study medication in capsule size and color"
10920046|NCT00661661|EG001|Reported Event|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
10920047|NCT00661661|EG002|Reported Event|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
10920048|NCT00661674|BG000|Baseline|Overall Study|Over three study sessions each spaced one week apart participants received either placebo IV + PO, Palonosetron IV (0.75 mg) + placebo PO, or Palonosetron IV (0.75 mg) + Hydroxyzine PO (100mg).
10920049|NCT00661674|FG000|Participant Flow|Sequence 1: Placebo, Combo, Palonosetron|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Placebo~Week 2: Combo~Week 3: Palonosetron"
10920050|NCT00661674|FG001|Participant Flow|Sequence 2: Palonosetron, Combo, Placebo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Palonosetron~Week 2: Combo~Week 3: Placebo"
10920051|NCT00661674|FG002|Participant Flow|Sequence 3: Combo, Placebo, Palonosetron|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Combo~Week 2: Placebo~Week 3: Palonosetron"
10920052|NCT00661674|FG003|Participant Flow|Sequence 4: Placebo, Palonosetron, Combo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Placebo~Week 2: Palonosetron~Week 3: Combo"
10920053|NCT00661674|FG004|Participant Flow|Sequence 5: Combo, Palonosetron, Placebo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Combo~Week 2: Palonosetron~Week 3: Placebo"
10920054|NCT00661674|FG005|Participant Flow|Sequence 6: Palonosetron, Placebo, Combo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Palonosetron~Week 2: Placebo~Week 3: Combo"
10920055|NCT00661674|OG000|Outcome|Placebo|Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
10920056|NCT00661674|OG001|Outcome|Palonosetron|Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
10920057|NCT00661674|OG002|Outcome|Palonosetron + Hydroxyzine|Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
10920058|NCT00661674|EG000|Reported Event|Placebo|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with placebo (0.9% normal saline) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
10920059|NCT00661674|EG001|Reported Event|Palonosetron + Placebo|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study drug combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
10920060|NCT00661674|EG002|Reported Event|Palonosetron + Hydroxyzine|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
10920061|NCT00661687|BG000|Baseline|PureVision Contact Lens|PureVision Contact Lens Original Design and New Design.
10920062|NCT00661687|FG000|Participant Flow|PureVision Contact Lens|PureVision Contact Lens, Original Design and Alternate Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
10920063|NCT00661687|OG000|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
10920064|NCT00661687|OG001|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
10920065|NCT00661687|EG000|Reported Event|PureVision Contact Lens Design #1|PureVision Contact Lens, Original Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
10920066|NCT00661687|EG001|Reported Event|PureVision Contact Lens Design #2|PureVision Contact Lens Test Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye
10920067|NCT00661713|BG000|Baseline|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
10920068|NCT00661713|BG001|Baseline|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
10920069|NCT00661713|BG002|Baseline|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
10920070|NCT00661713|BG003|Baseline|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
10920071|NCT00661713|BG004|Baseline|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
10920072|NCT00661713|BG005|Baseline|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
10920073|NCT00661713|BG006|Baseline|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
10920074|NCT00661713|BG007|Baseline|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
10920075|NCT00661713|BG008|Baseline|Total|Total of all reporting groups
10920076|NCT00661713|FG000|Participant Flow|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
10920077|NCT00661713|FG001|Participant Flow|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
10920078|NCT00661713|FG002|Participant Flow|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
10920079|NCT00661713|FG003|Participant Flow|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
10920080|NCT00661713|FG004|Participant Flow|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
10920081|NCT00661713|FG005|Participant Flow|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
10920082|NCT00661713|FG006|Participant Flow|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
10920083|NCT00661713|FG007|Participant Flow|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
10920084|NCT00661713|OG000|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
10920085|NCT00661713|OG001|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
10920086|NCT00661713|OG002|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
10920087|NCT00661713|OG003|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
10920088|NCT00661713|OG004|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
10920089|NCT00661713|OG005|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
10920090|NCT00661713|OG006|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
10920091|NCT00661713|OG007|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
10920092|NCT00661713|OG000|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
10920093|NCT00661713|OG001|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
10920094|NCT00661713|EG000|Reported Event|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
10920095|NCT00661713|EG001|Reported Event|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
10920096|NCT00661713|EG002|Reported Event|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
10920097|NCT00661713|EG003|Reported Event|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
10920098|NCT00661713|EG004|Reported Event|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
10920099|NCT00661713|EG005|Reported Event|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
10920100|NCT00661713|EG006|Reported Event|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
10920101|NCT00661713|EG007|Reported Event|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
10963204|NCT00870740|EG004|Reported Event|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
10963205|NCT00870740|EG005|Reported Event|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
10964036|NCT00875550|OG001|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
10920102|NCT00661726|BG000|Baseline|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
10920103|NCT00661726|FG000|Participant Flow|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
10920104|NCT00661726|OG000|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
10920105|NCT00661726|EG000|Reported Event|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
10920106|NCT00661778|BG000|Baseline|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
10920107|NCT00661778|FG000|Participant Flow|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
10920108|NCT00661778|OG000|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
10920109|NCT00661778|EG000|Reported Event|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
10920110|NCT00661830|BG000|Baseline|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
10920111|NCT00661830|BG001|Baseline|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
10920112|NCT00661830|BG002|Baseline|Total|Total of all reporting groups
10920113|NCT00661830|FG000|Participant Flow|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
10920114|NCT00661830|FG001|Participant Flow|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
10920115|NCT00661830|OG000|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
10920116|NCT00661830|OG001|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
10920117|NCT00661830|EG000|Reported Event|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
10920118|NCT00661830|EG001|Reported Event|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
10920119|NCT00661895|BG000|Baseline|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
10920120|NCT00661895|BG001|Baseline|Control|No intervention
10920121|NCT00661895|BG002|Baseline|Total|Total of all reporting groups
10920122|NCT00661895|FG000|Participant Flow|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
10920123|NCT00661895|FG001|Participant Flow|Control|No intervention
10920124|NCT00661895|OG000|Outcome|Intervention|Free antihypertensive medications, in-depth HTN and healthy living education, behavior change counseling, and Therapeutic Lifestyle Change following JNC-VII guidelines.
10920125|NCT00661895|OG001|Outcome|Control|Free antihypertensive medications, basic hypertension education and usual clinical care.
10920126|NCT00661895|EG000|Reported Event|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
10920127|NCT00661895|EG001|Reported Event|Control|No intervention
10920128|NCT00661960|BG000|Baseline|Negative Volunteers|HIV Negative volunteers
10920129|NCT00661960|BG001|Baseline|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
10920130|NCT00661960|BG002|Baseline|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
10920131|NCT00661960|BG003|Baseline|Total|Total of all reporting groups
10920132|NCT00661960|FG000|Participant Flow|Negative Volunteers|HIV Negative volunteers
10920133|NCT00661960|FG001|Participant Flow|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
10920134|NCT00661960|FG002|Participant Flow|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
10920135|NCT00661960|OG000|Outcome|Negative Volunteers|HIV Negative volunteers
10920136|NCT00661960|OG001|Outcome|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
11174986|NCT02026063|BG000|Baseline|Telotristat Etiprate 250 mg|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study.
11174987|NCT02026063|BG001|Baseline|Telotristat Etiprate 500 mg|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study.
11174988|NCT02026063|BG002|Baseline|Total|Total of all reporting groups
11174989|NCT02026063|FG000|Participant Flow|Telotristat Etiprate 250 mg|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study.
11174990|NCT02026063|FG001|Participant Flow|Telotristat Etiprate 500 mg|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study.
11174991|NCT02026063|OG000|Outcome|Telotristat Etiprate 250 mg|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study.
11174992|NCT02026063|OG001|Outcome|Telotristat Etiprate 500 mg|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study.
11174993|NCT02026063|OG000|Outcome|Telotristat Etiprate (All Participants)|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Telotristat etiprate (250 or 500 mg) one or two tablets administered tid up to an additional 228 weeks (250 mg) or up to an additional 204 weeks (500 mg) in this long-term extension study.
11174994|NCT02026063|EG000|Reported Event|Telotristat Etiprate 250 mg|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study.
11174995|NCT02026063|EG001|Reported Event|Telotristat Etiprate 500 mg|Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study.
11174996|NCT02026141|BG000|Baseline|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr~Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation as defined by ASA.~Dexmedetomidine"
11174997|NCT02026141|BG001|Baseline|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
11174998|NCT02026141|BG002|Baseline|Total|Total of all reporting groups
11174999|NCT02026141|FG000|Participant Flow|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
11357599|NCT03754556|BG000|Baseline|Women With IUD|Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.
10920137|NCT00661960|OG002|Outcome|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
11234054|NCT02432105|FG000|Participant Flow|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
10920138|NCT00661960|EG000|Reported Event|Negative Volunteers|HIV Negative volunteers
10920139|NCT00661960|EG001|Reported Event|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
10920140|NCT00661960|EG002|Reported Event|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
10920141|NCT00661999|BG000|Baseline|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920142|NCT00661999|BG001|Baseline|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920143|NCT00661999|BG002|Baseline|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920144|NCT00661999|BG003|Baseline|Total|Total of all reporting groups
10920145|NCT00661999|FG000|Participant Flow|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920146|NCT00661999|FG001|Participant Flow|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920147|NCT00661999|FG002|Participant Flow|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920148|NCT00661999|OG000|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920149|NCT00661999|OG001|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920150|NCT00661999|OG002|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920151|NCT00661999|EG000|Reported Event|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920152|NCT00661999|EG001|Reported Event|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
11175000|NCT02026141|FG001|Participant Flow|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
10920153|NCT00661999|EG002|Reported Event|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
10920154|NCT00662012|BG000|Baseline|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
10920155|NCT00662012|FG000|Participant Flow|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
10920156|NCT00662012|OG000|Outcome|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
10920157|NCT00662012|EG000|Reported Event|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
10920158|NCT00662025|BG000|Baseline|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
10920159|NCT00662025|FG000|Participant Flow|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
10920160|NCT00662025|OG000|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
11175001|NCT02026141|OG000|Outcome|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
10920161|NCT00662025|EG000|Reported Event|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
10920162|NCT00662038|BG000|Baseline|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
10920163|NCT00662038|FG000|Participant Flow|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
10920164|NCT00662038|OG000|Outcome|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
10920165|NCT00662038|EG000|Reported Event|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
10920166|NCT00662129|BG000|Baseline|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10920167|NCT00662129|FG000|Participant Flow|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10920168|NCT00662129|OG000|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10920169|NCT00662129|EG000|Reported Event|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10920170|NCT00662155|BG000|Baseline|QHS-10|nightly dosing with 10 mg zolpidem
10920171|NCT00662155|BG001|Baseline|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
10920172|NCT00662155|BG002|Baseline|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
10920173|NCT00662155|BG003|Baseline|QHS-5|nightly dosing with 5mg zolpidem
10920174|NCT00662155|BG004|Baseline|Total|Total of all reporting groups
10920175|NCT00662155|FG000|Participant Flow|QHS-10|nightly dosing with 10 mg zolpidem
10920176|NCT00662155|FG001|Participant Flow|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
10920177|NCT00662155|FG002|Participant Flow|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
10920178|NCT00662155|FG003|Participant Flow|QHS-5|nightly dosing with 5mg zolpidem
10920179|NCT00662155|OG000|Outcome|QHS-10|nightly dosing with 10 mg zolpidem
10920180|NCT00662155|OG001|Outcome|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
10920181|NCT00662155|OG002|Outcome|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
10920182|NCT00662155|OG003|Outcome|QHS-5|nightly dosing with 5mg zolpidem
10920183|NCT00662155|EG000|Reported Event|QHS-10|nightly dosing with 10 mg zolpidem
10920184|NCT00662155|EG001|Reported Event|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
10920185|NCT00662155|EG002|Reported Event|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
10920186|NCT00662155|EG003|Reported Event|QHS-5|nightly dosing with 5mg zolpidem
10920187|NCT00662207|BG000|Baseline|All Participants|
10920188|NCT00662207|FG000|Participant Flow|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
10920189|NCT00662207|OG000|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
10920190|NCT00662207|EG000|Reported Event|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
10920191|NCT00662259|BG000|Baseline|Alprazolam|"Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.~Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks)."
10920192|NCT00662259|BG001|Baseline|Placebo|"A placebo comparator will be administered to 12 patients with generalized anxiety disorder~Placebo: Placebo, bid, p.o. for 28 +/- 2 days."
10920193|NCT00662259|BG002|Baseline|Total|Total of all reporting groups
10920194|NCT00662259|FG000|Participant Flow|Alprazolam|"Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.~Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks)."
10920195|NCT00662259|FG001|Participant Flow|Placebo|"A placebo comparator will be administered to 12 patients with generalized anxiety disorder~Placebo: Placebo, bid, p.o. for 28 +/- 2 days."
10920196|NCT00662259|OG000|Outcome|Alprazolam|"Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.~Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks)."
10920197|NCT00662259|OG001|Outcome|Placebo|"A placebo comparator will be administered to 12 patients with generalized anxiety disorder~Placebo: Placebo, bid, p.o. for 28 +/- 2 days."
10920198|NCT00662259|EG000|Reported Event|Alprazolam|"Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.~Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks)."
10920199|NCT00662259|EG001|Reported Event|Placebo|"A placebo comparator will be administered to 12 patients with generalized anxiety disorder~Placebo: Placebo, bid, p.o. for 28 +/- 2 days."
10920200|NCT00662298|BG000|Baseline|Severe Asthma|prednisolone: 40mg of prednisolone once a day for 14 days
11357600|NCT03754556|FG000|Participant Flow|Women With IUD|Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.
10920201|NCT00662298|FG000|Participant Flow|Severe Asthma|prednisolone: 40mg of prednisolone once a day for 14 days
10920202|NCT00662298|OG000|Outcome|Severe Asthma|prednisolone: 40mg of prednisolone once a day for 14 days
10920203|NCT00662298|EG000|Reported Event|Severe Asthma|prednisolone: 40mg of prednisolone once a day for 14 days
10920204|NCT00662311|BG000|Baseline|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920205|NCT00662311|BG001|Baseline|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920206|NCT00662311|BG002|Baseline|Vorinostat 400 mg|"Cohort 3: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920207|NCT00662311|BG003|Baseline|Total|Total of all reporting groups
10920208|NCT00662311|FG000|Participant Flow|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920209|NCT00662311|FG001|Participant Flow|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920210|NCT00662311|FG002|Participant Flow|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920211|NCT00662311|OG000|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920212|NCT00662311|OG001|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920213|NCT00662311|OG002|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920214|NCT00662311|EG000|Reported Event|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920215|NCT00662311|EG001|Reported Event|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920216|NCT00662311|EG002|Reported Event|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
10920217|NCT00662363|BG000|Baseline|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
10920218|NCT00662363|BG001|Baseline|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
10920219|NCT00662363|BG002|Baseline|Total|Total of all reporting groups
10920220|NCT00662363|FG000|Participant Flow|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
10920221|NCT00662363|FG001|Participant Flow|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
10920222|NCT00662363|OG000|Outcome|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
11234055|NCT02432105|FG001|Participant Flow|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
11234056|NCT02432105|FG002|Participant Flow|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
10920223|NCT00662363|OG001|Outcome|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
10920224|NCT00662363|OG000|Outcome|Lubiprostone|change in PAC-QOL
10920225|NCT00662363|OG001|Outcome|Senna|Change in PAC-QOL
10920226|NCT00662363|EG000|Reported Event|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
10920227|NCT00662363|EG001|Reported Event|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
10920228|NCT00662532|BG000|Baseline|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
10920229|NCT00662532|BG001|Baseline|No Intervention|Control group receiving no drug intervention
10920230|NCT00662532|BG002|Baseline|Total|Total of all reporting groups
10920231|NCT00662532|FG000|Participant Flow|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
10920232|NCT00662532|FG001|Participant Flow|No Intervention|Control group receiving no drug intervention
10920233|NCT00662532|OG000|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
10920234|NCT00662532|OG001|Outcome|No Intervention|Control group receiving no drug intervention
10920235|NCT00662532|EG000|Reported Event|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
10920236|NCT00662532|EG001|Reported Event|No Intervention|Control group receiving no drug intervention
10920237|NCT00662545|BG000|Baseline|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
10920238|NCT00662545|BG001|Baseline|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
10920239|NCT00662545|BG002|Baseline|Total|Total of all reporting groups
10920240|NCT00662545|FG000|Participant Flow|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
10920241|NCT00662545|FG001|Participant Flow|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
10920242|NCT00662545|OG000|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
10920243|NCT00662545|OG001|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
10920244|NCT00662545|EG000|Reported Event|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
10920245|NCT00662545|EG001|Reported Event|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
10920246|NCT00662558|BG000|Baseline|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
10920247|NCT00662558|BG001|Baseline|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
10920248|NCT00662558|BG002|Baseline|Total|Total of all reporting groups
10920249|NCT00662558|FG000|Participant Flow|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
10920250|NCT00662558|FG001|Participant Flow|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
10920251|NCT00662558|OG000|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
10920252|NCT00662558|OG001|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
10920253|NCT00662558|EG000|Reported Event|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
10920254|NCT00662558|EG001|Reported Event|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
10920255|NCT00662649|BG000|Baseline|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
10920256|NCT00662649|BG001|Baseline|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
10920257|NCT00662649|BG002|Baseline|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
10920258|NCT00662649|BG003|Baseline|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
10920259|NCT00662649|BG004|Baseline|Total|Total of all reporting groups
11234057|NCT02432105|OG000|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
11234058|NCT02432105|OG001|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
11234059|NCT02432105|OG002|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
11234060|NCT02432105|EG000|Reported Event|Pretreatment|All AEs reported prior to randomization
11234061|NCT02432105|EG001|Reported Event|EXE844 7 Days|All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion
10920260|NCT00662649|FG000|Participant Flow|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
10920261|NCT00662649|FG001|Participant Flow|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
10920262|NCT00662649|FG002|Participant Flow|Placebo|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
10920263|NCT00662649|FG003|Participant Flow|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
10920264|NCT00662649|FG004|Participant Flow|Placebo-fingolimod 0.5|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
10920265|NCT00662649|OG000|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
10920266|NCT00662649|OG001|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
10920267|NCT00662649|OG002|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
10920268|NCT00662649|OG002|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
10920269|NCT00662649|OG003|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
10920270|NCT00662649|OG002|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the Core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
10920271|NCT00662649|OG002|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod (either 1.25 or 0.5 mg/day) in the Extension study.
10920272|NCT00662649|OG002|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
10920273|NCT00662649|EG000|Reported Event|Fingolimod 1.25mg|Patients randomized to fingolimod 1.25 mg/day in the Core study. These patients continued the same dose in the Extension study.
10920274|NCT00662649|EG001|Reported Event|Fingolimod 0.5mg|Patients randomized to fingolimod 0.5 mg/day in the Core study. These patients continued the same dose in the Extension study.
10920275|NCT00662649|EG002|Reported Event|Placebo-Fingolimod 1.25mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 1.25 mg/day in the Extension study.
10920276|NCT00662649|EG003|Reported Event|Placebo-Fingolimod 0.5mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 0.5 mg/day in the Extension study.
10920277|NCT00662675|BG000|Baseline|Placebo|Matching placebo capsules taken by mouth per meal or snack
10920278|NCT00662675|BG001|Baseline|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
10920279|NCT00662675|BG002|Baseline|Total|Total of all reporting groups
10920280|NCT00662675|FG000|Participant Flow|Placebo|Matching placebo capsules taken by mouth per meal or snack
10920281|NCT00662675|FG001|Participant Flow|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
10920282|NCT00662675|OG000|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
10920283|NCT00662675|OG001|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
10920284|NCT00662675|EG000|Reported Event|Placebo|Matching placebo capsules taken by mouth per meal or snack
10920285|NCT00662675|EG001|Reported Event|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
10920286|NCT00662818|BG000|Baseline|Telcagepant 300 mg→APAP 1000 mg|Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
10920287|NCT00662818|BG001|Baseline|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
10920288|NCT00662818|BG002|Baseline|Total|Total of all reporting groups
10920289|NCT00662818|FG000|Participant Flow|Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg|Participants receive up to 12 doses of telcagepant (300 mg capsule/280 mg tablet), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
10920290|NCT00662818|FG001|Participant Flow|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
10920291|NCT00662818|OG000|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
10920292|NCT00662818|OG001|Outcome|Placebo|Participants receiving placebo
10920293|NCT00662818|OG001|Outcome|Acetaminophen/Paracetamol (APAP)|Participants receiving APAP
10920294|NCT00662818|OG001|Outcome|APAP|Participants receiving APAP
10920295|NCT00662818|EG000|Reported Event|Telcagepant|Participants receiving telcagepant
10920296|NCT00662818|EG001|Reported Event|Acetaminophen/Paracetamol|Participants receiving acetaminophen/paracetamol
10920297|NCT00662831|BG000|Baseline|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
10920298|NCT00662831|BG001|Baseline|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
10920299|NCT00662831|BG002|Baseline|Total|Total of all reporting groups
10920300|NCT00662831|FG000|Participant Flow|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 milliliter [mL]) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
10920301|NCT00662831|FG001|Participant Flow|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
10920302|NCT00662831|OG000|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
10920303|NCT00662831|OG001|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
10920304|NCT00662831|EG000|Reported Event|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
10920305|NCT00662831|EG001|Reported Event|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
10920306|NCT00662857|BG000|Baseline|Safety Population|Any subject that received at least one treatment with TI inhalation powder
10920307|NCT00662857|FG000|Participant Flow|TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
10920308|NCT00662857|FG001|Participant Flow|TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
10920309|NCT00662857|OG000|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
10920310|NCT00662857|OG001|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
10920311|NCT00662857|OG000|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
10920312|NCT00662857|OG001|Outcome|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
10920313|NCT00662857|EG000|Reported Event|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
10920314|NCT00662857|EG001|Reported Event|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
10920315|NCT00662857|EG002|Reported Event|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
10920316|NCT00662909|BG000|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
10920317|NCT00662909|BG001|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
10920318|NCT00662909|BG002|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
10920319|NCT00662909|BG003|Baseline|Total|Total of all reporting groups
10920320|NCT00662909|FG000|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
10920321|NCT00662909|FG001|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
10920322|NCT00662909|FG002|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
10920323|NCT00662909|OG000|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
10920324|NCT00662909|OG001|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
10920325|NCT00662909|OG002|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
10920326|NCT00662909|EG000|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
10920327|NCT00662909|EG001|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
10920328|NCT00662909|EG002|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
10920329|NCT00663026|BG000|Baseline|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
10920330|NCT00663026|BG001|Baseline|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
10920331|NCT00663026|BG002|Baseline|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
10920332|NCT00663026|BG003|Baseline|Total|Total of all reporting groups
10920333|NCT00663026|FG000|Participant Flow|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
10920334|NCT00663026|FG001|Participant Flow|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
10920335|NCT00663026|FG002|Participant Flow|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
10920336|NCT00663026|OG000|Outcome|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
10920337|NCT00663026|OG001|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
10920338|NCT00663026|OG002|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
10920339|NCT00663026|OG000|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
10920340|NCT00663026|OG001|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
10920341|NCT00663026|EG000|Reported Event|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
10920342|NCT00663026|EG001|Reported Event|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
10920343|NCT00663026|EG002|Reported Event|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
10920344|NCT00663039|BG000|Baseline|All Study Participants|Participants who were screened and met inclusion/exclusion criteria for the study.
10920345|NCT00663039|FG000|Participant Flow|Oxytocin, Then Placebo|Participants first received 24IU of Oxytocin administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received placebo.
10920346|NCT00663039|FG001|Participant Flow|Placebo, Then Oxytocin|Participants first received a placebo (saline nasal spray) administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received Oxytocin.
10920347|NCT00663039|OG000|Outcome|Oxytocin|Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.
10920348|NCT00663039|OG001|Outcome|Placebo|Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
10920349|NCT00663039|EG000|Reported Event|Oxytocin|Oxytocin administered on study
10920350|NCT00663039|EG001|Reported Event|Placebo|Placebo administered on study day
10920351|NCT00663117|BG000|Baseline|Placebo Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
10920352|NCT00663117|BG001|Baseline|Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
10920353|NCT00663117|BG002|Baseline|Total|Total of all reporting groups
10920354|NCT00663117|FG000|Participant Flow|Placebo Then Naltrexone 4.5 mg Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
10920355|NCT00663117|FG001|Participant Flow|Naltrexone Then Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
10920356|NCT00663117|OG000|Outcome|Placebo|Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
10920357|NCT00663117|OG001|Outcome|Naltrexone 4.5 mg po Daily|Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
10920358|NCT00663117|OG000|Outcome|Placebo|Quality of life in subjects on placebo treatment for 12 weeks
10920359|NCT00663117|OG001|Outcome|Naltrexone 4.5 mg po Daily|Quality of life on naltrexone treatment 12 weeks
10920360|NCT00663117|OG000|Outcome|Placebo|Placebo for 12 weeks blinded followed by naltrexone 4.5mg open labeled
10920361|NCT00663117|OG001|Outcome|Naltrexone 4.5 mg|naltrexone 4.5 mg for 12 weeks blinded followed by naltrexone 4.5 mg open labeled
10920362|NCT00663117|OG000|Outcome|Placebo|Subjects who received placebo for 3 months
10920363|NCT00663117|OG001|Outcome|Naltrexone 4.5 mg po Daily|Subjects who received naltrexone 4.5 mg by mouth once a day for 3 months
10920364|NCT00663117|EG000|Reported Event|Placebo|Participants who received placebo for the first 12 weeks.
10920365|NCT00663117|EG001|Reported Event|Naltrexone 4.5 mg|All participants who received naltrexone either for 12 or 24 weeks.
10920366|NCT00663169|BG000|Baseline|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
10920367|NCT00663169|BG001|Baseline|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
10920368|NCT00663169|BG002|Baseline|Total|Total of all reporting groups
10920369|NCT00663169|FG000|Participant Flow|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
10920370|NCT00663169|FG001|Participant Flow|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
10920371|NCT00663169|OG000|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
10920372|NCT00663169|OG001|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
10920373|NCT00663169|EG000|Reported Event|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
10920374|NCT00663169|EG001|Reported Event|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
10920375|NCT00663208|BG000|Baseline|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920376|NCT00663208|BG001|Baseline|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920377|NCT00663208|BG002|Baseline|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920378|NCT00663208|BG003|Baseline|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920379|NCT00663208|BG004|Baseline|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920380|NCT00663208|BG005|Baseline|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920381|NCT00663208|BG006|Baseline|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
10920382|NCT00663208|BG007|Baseline|Total|Total of all reporting groups
10920383|NCT00663208|FG000|Participant Flow|Daclatasvir (1 mg) QD|Participants received once daily (QD) dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920384|NCT00663208|FG001|Participant Flow|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920385|NCT00663208|FG002|Participant Flow|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920386|NCT00663208|FG003|Participant Flow|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920387|NCT00663208|FG004|Participant Flow|Daclatasvir (30 mg) BID|Participants received twice daily (BID) dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920388|NCT00663208|FG005|Participant Flow|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920389|NCT00663208|FG006|Participant Flow|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
10920390|NCT00663208|OG000|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920391|NCT00663208|OG001|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920392|NCT00663208|OG002|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920393|NCT00663208|OG003|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920394|NCT00663208|OG004|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
11234062|NCT02432105|EG002|Reported Event|EXE844 3 Days|All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 3 days after Tympanostomy Tube Insertion
11234063|NCT02432105|EG003|Reported Event|Tubes Only|All participants treated with bilateral myringotomy and tympanostomy tube insertion only
11234064|NCT02432144|BG000|Baseline|UX003|4 mg/kg UX003 QOW
10920395|NCT00663208|OG005|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920396|NCT00663208|OG006|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
10920397|NCT00663208|OG003|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182..
10920398|NCT00663208|OG000|Outcome|All Daclatasvir Treated Participants|All participants who received daclatasvir during 14 day treatment period.
10920399|NCT00663208|EG000|Reported Event|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received Daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920400|NCT00663208|EG001|Reported Event|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920401|NCT00663208|EG002|Reported Event|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920402|NCT00663208|EG003|Reported Event|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920403|NCT00663208|EG004|Reported Event|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920404|NCT00663208|EG005|Reported Event|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
10920405|NCT00663208|EG006|Reported Event|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
10920406|NCT00663234|BG000|Baseline|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
10920407|NCT00663234|FG000|Participant Flow|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4.
10920408|NCT00663234|OG000|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
10920409|NCT00663234|OG000|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
11234065|NCT02432144|FG000|Participant Flow|UX003|4 mg/kg UX003 every other week (QOW)
11234066|NCT02432144|OG000|Outcome|UX003|4 mg/kg UX003 QOW
11234067|NCT02432144|EG000|Reported Event|UX003|4 mg/kg UX003 QOW
11234068|NCT02432183|BG000|Baseline|Football Players|Football players of the first grade of high school are recruited from the topsportschool in Leuven.
11234069|NCT02432183|BG001|Baseline|Swimmers|Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation
11234070|NCT02432183|BG002|Baseline|Basketball Players|Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.
11234071|NCT02432183|BG003|Baseline|Control Group|Age-matched controls are recruited (exercising at a recreational level, >4 hours).
11234072|NCT02432183|BG004|Baseline|Total|Total of all reporting groups
11234073|NCT02432183|FG000|Participant Flow|Football Players|Football players of the first grade of high school are recruited from the topsportschool in Leuven.
10920410|NCT00663234|OG001|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
10920411|NCT00663234|OG000|Outcome|NNRTI-exposed|Participant was on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
10920412|NCT00663234|OG001|Outcome|NNRTI-unexposed|Participant was not on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
10920413|NCT00663234|EG000|Reported Event|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
10920414|NCT00663260|BG000|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
10920415|NCT00663260|BG001|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
10920416|NCT00663260|BG002|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
10920417|NCT00663260|BG003|Baseline|Total|Total of all reporting groups
10920418|NCT00663260|FG000|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
10920419|NCT00663260|FG001|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
10920420|NCT00663260|FG002|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
10920421|NCT00663260|OG000|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
10920422|NCT00663260|OG001|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
10920423|NCT00663260|OG002|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
10920424|NCT00663260|EG000|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
10920425|NCT00663260|EG001|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
10920426|NCT00663260|EG002|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
10920427|NCT00663403|BG000|Baseline|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
10920428|NCT00663403|FG000|Participant Flow|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
10920429|NCT00663403|OG000|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
10920430|NCT00663403|EG000|Reported Event|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
10920431|NCT00663702|BG000|Baseline|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
10920432|NCT00663702|BG001|Baseline|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
10920433|NCT00663702|BG002|Baseline|Total|Total of all reporting groups
11234074|NCT02432183|FG001|Participant Flow|Swimmers|Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation
10920434|NCT00663702|FG000|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
10920435|NCT00663702|FG001|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
10920436|NCT00663702|OG000|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
10920437|NCT00663702|OG000|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
10920438|NCT00663702|OG001|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
10920439|NCT00663702|EG000|Reported Event|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
10920440|NCT00663793|BG000|Baseline|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
10920441|NCT00663793|BG001|Baseline|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
10920442|NCT00663793|BG002|Baseline|Total|Total of all reporting groups
10920443|NCT00663793|FG000|Participant Flow|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
10920444|NCT00663793|FG001|Participant Flow|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
10920445|NCT00663793|OG000|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
10920446|NCT00663793|OG001|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
10920447|NCT00663793|EG000|Reported Event|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
10920448|NCT00663793|EG001|Reported Event|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
10920449|NCT00663819|BG000|Baseline|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
10920450|NCT00663819|BG001|Baseline|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
10920451|NCT00663819|BG002|Baseline|Total|Total of all reporting groups
10920452|NCT00663819|FG000|Participant Flow|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
10920453|NCT00663819|FG001|Participant Flow|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
10920454|NCT00663819|OG000|Outcome|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
10920455|NCT00663819|OG001|Outcome|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
10920456|NCT00663819|OG000|Outcome|Device|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
10920457|NCT00663819|OG001|Outcome|Procedure/Surgery|Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
10920458|NCT00663819|EG000|Reported Event|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
10920459|NCT00663819|EG001|Reported Event|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
10920460|NCT00663858|BG000|Baseline|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
10920461|NCT00663858|BG001|Baseline|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
10920462|NCT00663858|BG002|Baseline|Placebo|Placebo on Week 0, 2, 26 and 28.
10920463|NCT00663858|BG003|Baseline|Total|Total of all reporting groups
10920464|NCT00663858|FG000|Participant Flow|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
10920465|NCT00663858|FG001|Participant Flow|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
10920466|NCT00663858|FG002|Participant Flow|Placebo|Placebo on Week 0, 2, 26 and 28.
10920467|NCT00663858|OG000|Outcome|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
10920468|NCT00663858|OG001|Outcome|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
10920469|NCT00663858|OG002|Outcome|Placebo|Placebo on Week 0, 2, 26 and 28.
10920470|NCT00663858|EG000|Reported Event|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
10920471|NCT00663858|EG001|Reported Event|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
10920472|NCT00663858|EG002|Reported Event|Placebo|Placebo on Week 0, 2, 26 and 28.
10920473|NCT00663871|BG000|Baseline|Fish Oil|"Participants will take fish oil supplements daily for 4 months.~Fish Oil: Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis."
10920474|NCT00663871|BG001|Baseline|Placebo|"Participants will take soybean oil (placebo) supplements daily for 4 months.~Soybean Oil (Placebo): Participants will take 2 grams of soybean oil supplements on a daily basis."
10920475|NCT00663871|BG002|Baseline|Total|Total of all reporting groups
10920476|NCT00663871|FG000|Participant Flow|Fish Oil|"Participants will take fish oil supplements daily for 4 months.~Fish Oil: Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis."
10920477|NCT00663871|FG001|Participant Flow|Placebo|"Participants will take soybean oil (placebo) supplements daily for 4 months.~Soybean Oil (Placebo): Participants will take 2 grams of soybean oil supplements on a daily basis."
10920478|NCT00663871|OG000|Outcome|Fish Oil|"Participants will take fish oil supplements daily for 4 months.~Fish Oil: Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis."
10920479|NCT00663871|OG001|Outcome|Placebo|"Participants will take soybean oil (placebo) supplements daily for 4 months.~Soybean Oil (Placebo): Participants will take 2 grams of soybean oil supplements on a daily basis."
10920480|NCT00663871|OG000|Outcome|Fish Oil|
10920481|NCT00663871|OG001|Outcome|Placebo|
10920482|NCT00663871|EG000|Reported Event|Fish Oil|"Participants will take fish oil supplements daily for 4 months.~Fish Oil: Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis."
11234075|NCT02432183|FG002|Participant Flow|Basketball Players|Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.
10920483|NCT00663871|EG001|Reported Event|Placebo|"Participants will take soybean oil (placebo) supplements daily for 4 months.~Soybean Oil (Placebo): Participants will take 2 grams of soybean oil supplements on a daily basis."
10920484|NCT00663923|BG000|Baseline|Photorefractive Keratectomy( PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .In single method the steepest meridian is treated by elliptical ablation to match the flattest meridian.
10920485|NCT00663923|FG000|Participant Flow|Photorefractivekeratectomy(PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .in single method,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
10920486|NCT00663923|OG000|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
10920487|NCT00663923|OG001|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
10920488|NCT00663923|EG000|Reported Event|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
10920489|NCT00663923|EG001|Reported Event|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
10920490|NCT00663962|BG000|Baseline|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
10920491|NCT00663962|BG001|Baseline|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
10920492|NCT00663962|BG002|Baseline|Total|Total of all reporting groups
10920493|NCT00663962|FG000|Participant Flow|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
10920494|NCT00663962|FG001|Participant Flow|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
10920495|NCT00663962|OG000|Outcome|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
10920496|NCT00663962|OG001|Outcome|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
10920497|NCT00663962|EG000|Reported Event|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
10920498|NCT00663962|EG001|Reported Event|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
10920499|NCT00664105|BG000|Baseline|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
10920500|NCT00664105|FG000|Participant Flow|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
10920501|NCT00664105|OG000|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
10920502|NCT00664105|OG000|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
10920503|NCT00664105|EG000|Reported Event|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
10920504|NCT00664209|BG000|Baseline|Active|H. Pylori positive participants screened for eligibility to a treatment assignment.
10920505|NCT00664209|FG000|Participant Flow|Active|"Those with significant wearing-off were to be assigned to arms, and received open-label triple eradication therapy (standard of care) per physician decision because the screen yield was too low to test effect size between arms.~---- Clarithromycin 500mg - i PO BID x10 days; Amoxicillin 1gm - i PO BID x10 days; Omeprazole 10mg - i PO BID x10 days"
10920506|NCT00664209|OG000|Outcome|Active|Standard treatment with active triple therapy
10920507|NCT00664209|OG000|Outcome|Active|standard treatment with active triple therapy
10920508|NCT00664209|EG000|Reported Event|Active|Standard treatment with active triple therapy
10920509|NCT00664326|BG000|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
10920510|NCT00664326|FG000|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
10920511|NCT00664326|OG000|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
10920512|NCT00664326|EG000|Reported Event|Regorafenib (BAY73-4506)|Subjects received regorafenib 160 mg po qd for 3 weeks of every 4 week cycle (3 weeks on, 1 week off).
10920513|NCT00664430|BG000|Baseline|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
10920514|NCT00664430|FG000|Participant Flow|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
10920515|NCT00664430|OG000|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
10920516|NCT00664430|EG000|Reported Event|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
10920517|NCT00664521|BG000|Baseline|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
10920518|NCT00664521|BG001|Baseline|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
10920519|NCT00664521|BG002|Baseline|Total|Total of all reporting groups
10920520|NCT00664521|FG000|Participant Flow|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
10920521|NCT00664521|FG001|Participant Flow|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
10920522|NCT00664521|OG000|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
10920523|NCT00664521|OG001|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
10920524|NCT00664521|EG000|Reported Event|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
10920525|NCT00664521|EG001|Reported Event|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
10920526|NCT00664534|BG000|Baseline|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
10920527|NCT00664534|BG001|Baseline|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
10920528|NCT00664534|BG002|Baseline|Total|Total of all reporting groups
10920529|NCT00664534|FG000|Participant Flow|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
10920530|NCT00664534|FG001|Participant Flow|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
10920531|NCT00664534|OG000|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
10920532|NCT00664534|OG001|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
10920533|NCT00664534|EG000|Reported Event|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs
10920534|NCT00664534|EG001|Reported Event|Glargine|Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs
10920535|NCT00664560|BG000|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
10920536|NCT00664560|BG001|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
10920537|NCT00664560|BG002|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
10920538|NCT00664560|BG003|Baseline|Total|Total of all reporting groups
10920539|NCT00664560|FG000|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
10920540|NCT00664560|FG001|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
10920541|NCT00664560|FG002|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
10920542|NCT00664560|OG000|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
10920543|NCT00664560|OG001|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
10920544|NCT00664560|OG002|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
10920545|NCT00664560|EG000|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
10920546|NCT00664560|EG001|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
10920547|NCT00664560|EG002|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
10920548|NCT00664742|BG000|Baseline|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
10920549|NCT00664742|FG000|Participant Flow|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
10920550|NCT00664742|OG000|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
10920551|NCT00664742|EG000|Reported Event|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
10920552|NCT00664755|BG000|Baseline|Varenicline|"Participant randomized to receive active varenicline and placebo transdermal nicotine patch.~varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID~Varenicline is taken for a duration of 4 weeks in this study."
10920553|NCT00664755|BG001|Baseline|Transdermal Nicotine Patch|"Participant randomized to receive active transdermal nicotine patch and placebo varenicline.~transdermal nicotine patch: Weeks 0-3: 21mg patch~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
10920554|NCT00664755|BG002|Baseline|Total|Total of all reporting groups
10920555|NCT00664755|FG000|Participant Flow|Varenicline|"Participant randomized to receive active varenicline and placebo transdermal nicotine patch.~varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID~Varenicline is taken for a duration of 4 weeks in this study."
10920556|NCT00664755|FG001|Participant Flow|Transdermal Nicotine Patch|"Participant randomized to receive active transdermal nicotine patch and placebo varenicline.~transdermal nicotine patch: Weeks 0-3: 21mg patch~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
10920557|NCT00664755|OG000|Outcome|Varenicline|"Participant randomized to receive active varenicline and placebo transdermal nicotine patch.~varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID~Varenicline is taken for a duration of 4 weeks in this study."
10920558|NCT00664755|OG001|Outcome|Transdermal Nicotine Patch|"Participant randomized to receive active transdermal nicotine patch and placebo varenicline.~transdermal nicotine patch: Weeks 0-3: 21mg patch~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
10920559|NCT00664755|EG000|Reported Event|Varenicline|"Participant randomized to receive active varenicline and placebo transdermal nicotine patch.~varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID~Varenicline is taken for a duration of 4 weeks in this study."
10920560|NCT00664755|EG001|Reported Event|Transdermal Nicotine Patch|"Participant randomized to receive active transdermal nicotine patch and placebo varenicline.~transdermal nicotine patch: Weeks 0-3: 21mg patch~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
10920561|NCT00664859|BG000|Baseline|LCP-AtorFen 40/100mg|Data presented by previous double-blind study assignment
10920562|NCT00664859|BG001|Baseline|Atorvastatin 40 mg|Data presented by previous double-blind study assignment
10920563|NCT00664859|BG002|Baseline|Fenofibrate 145 mg|Data presented by previous double-blind study assignment
10920564|NCT00664859|BG003|Baseline|Total|Total of all reporting groups
10920565|NCT00664859|FG000|Participant Flow|LCP-AtorFen 40/100 mg|Subjects randomized to LCP-AtorFen 40/100 mg/day in the DB portion of the study
10920566|NCT00664859|FG001|Participant Flow|Atorvastatin 40 mg|Subjects randomized to Atorvastatin 40 mg/day in the DB portion of the study
10920567|NCT00664859|FG002|Participant Flow|Fenofibrate 145 mg|Subjects randomized to Fenofibrate 145 mg/day in the DB portion of the study
10920568|NCT00664859|OG000|Outcome|LCP-AtorFen 40/100mg|Data presented by previous double-blind study assignment
10920569|NCT00664859|OG001|Outcome|Atorvastatin 40 mg|Data presented by previous double-blind study assignment
10920570|NCT00664859|OG002|Outcome|Fenofibrate 145 mg|Data presented by previous double-blind study assignment
10920571|NCT00664859|EG000|Reported Event|LCP-AtorFen 40/100mg|Data presented by previous double-blind study assignment
10920572|NCT00664859|EG001|Reported Event|Atorvastatin 40 mg|Data presented by previous double-blind study assignment
10920573|NCT00664859|EG002|Reported Event|Fenofibrate 145 mg|Data presented by previous double-blind study assignment
10920574|NCT00665002|BG000|Baseline|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
10920575|NCT00665002|FG000|Participant Flow|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
10920576|NCT00665002|OG000|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
10920577|NCT00665002|EG000|Reported Event|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks.
10920578|NCT00665132|BG000|Baseline|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
10920579|NCT00665132|FG000|Participant Flow|StimRouter Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Patient is Implanted with StimRouter System lead and receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
10920580|NCT00665132|OG000|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
10920581|NCT00665132|EG000|Reported Event|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
10920582|NCT00665353|BG000|Baseline|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
11234076|NCT02432183|FG003|Participant Flow|Control Group|Age-matched controls are recruited (exercising at a recreational level, >4 hours).
10920583|NCT00665353|FG000|Participant Flow|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
10920584|NCT00665353|OG000|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
10920585|NCT00665353|EG000|Reported Event|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
10920586|NCT00665366|BG000|Baseline|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
10920587|NCT00665366|BG001|Baseline|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
10920588|NCT00665366|BG002|Baseline|Total|Total of all reporting groups
10920589|NCT00665366|FG000|Participant Flow|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
10920590|NCT00665366|FG001|Participant Flow|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
11175002|NCT02026141|OG001|Outcome|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
10920591|NCT00665366|OG000|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
10920592|NCT00665366|OG001|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
10920593|NCT00665366|EG000|Reported Event|Aripiprazole|
10920594|NCT00665366|EG001|Reported Event|Placebo|
10920595|NCT00665392|BG000|Baseline|Cetuximab|"cisplatin: 75 mg/m², day 1. 3 cycles~docetaxel: 75 mg/m² Day 1. 3 cycles~fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles~Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles."
10920596|NCT00665392|FG000|Participant Flow|ETPF Adminstration|"cisplatin: 75 mg/m², day 1. 3 cycles~docetaxel: 75 mg/m² Day 1. 3 cycles~fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles~Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles."
10920597|NCT00665392|OG000|Outcome|ETPF Administration|"cisplatin: 75 mg/m², day 1. 3 cycles~docetaxel: 75 mg/m² Day 1. 3 cycles~fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles~Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles."
10920598|NCT00665392|OG000|Outcome|ETPF Administration|"Treatment consisted of cetuximab by intravenous (IV) infusion over 1-2 h on days 1, 8, and 15 (loading dose of 400 mg/m2 on day 1, then 250 mg/m2 weekly) followed the same day by docetaxel and cisplatin both given as a~1h IV infusion (at a 75 mg/m2 dose) and by 5-FU IV infusion on days 1-5 (at a 750 mg/m2 dose per day). Treatment was given every 3 weeks for a maximum of three cycles."
10920599|NCT00665392|EG000|Reported Event|ETPF Administration|"cisplatin: 75 mg/m², day 1. 3 cycles~docetaxel: 75 mg/m² Day 1. 3 cycles~fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles~Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles."
10920600|NCT00665431|BG000|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
10920601|NCT00665431|BG001|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
10920602|NCT00665431|BG002|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
10920603|NCT00665431|BG003|Baseline|Total|Total of all reporting groups
10920604|NCT00665431|FG000|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
10920605|NCT00665431|FG001|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
10920606|NCT00665431|FG002|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
10920607|NCT00665431|OG000|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
10920608|NCT00665431|OG001|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
10920609|NCT00665431|OG002|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
10920610|NCT00665431|EG000|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
10920611|NCT00665431|EG001|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
10920612|NCT00665431|EG002|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
10920613|NCT00665457|BG000|Baseline|Celecoxib|"•Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.~Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery.~•Surgery: standard of care"
10920614|NCT00665457|FG000|Participant Flow|Celecoxib|"•Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.~Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery.~•Surgery: standard of care"
10920615|NCT00665457|OG000|Outcome|Celecoxib|"•Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.~Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery.~•Surgery: standard of care"
10920616|NCT00665457|EG000|Reported Event|Celecoxib|"•Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.~Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery.~•Surgery: standard of care"
10920617|NCT00665470|BG000|Baseline|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
10920618|NCT00665470|BG001|Baseline|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
10920619|NCT00665470|BG002|Baseline|Total|Total of all reporting groups
10920620|NCT00665470|FG000|Participant Flow|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
10920621|NCT00665470|FG001|Participant Flow|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
10920622|NCT00665470|OG000|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
10920623|NCT00665470|OG001|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
10920624|NCT00665470|EG000|Reported Event|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
10920625|NCT00665470|EG001|Reported Event|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
10920626|NCT00665561|BG000|Baseline|Maraviroc Exposed|Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
10920627|NCT00665561|BG001|Baseline|Maraviroc Unexposed|HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
10920628|NCT00665561|BG002|Baseline|Total|Total of all reporting groups
10920629|NCT00665561|FG000|Participant Flow|Maraviroc Exposed|Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
10920630|NCT00665561|FG001|Participant Flow|Maraviroc Unexposed|HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
10920631|NCT00665561|OG000|Outcome|Maraviroc Exposed|Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
10920632|NCT00665561|OG001|Outcome|Maraviroc Unexposed|HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
10920633|NCT00665561|EG000|Reported Event|Maraviroc Exposed|Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
10920634|NCT00665561|EG001|Reported Event|Maraviroc Unexposed|HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
10920635|NCT00665626|BG000|Baseline|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
10920636|NCT00665626|BG001|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
10920637|NCT00665626|BG002|Baseline|Total|Total of all reporting groups
10920638|NCT00665626|FG000|Participant Flow|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
10920639|NCT00665626|FG001|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
11234077|NCT02432183|OG000|Outcome|Football Players|Football players of the first grade of high school are recruited from the topsportschool in Leuven.
10920640|NCT00665626|OG000|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
10920641|NCT00665626|OG001|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
10920642|NCT00665626|EG000|Reported Event|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
10920643|NCT00665626|EG001|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
10920644|NCT00665652|BG000|Baseline|Lenalidomide|Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
10920645|NCT00665652|FG000|Participant Flow|Lenalidomide|Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
10920646|NCT00665652|OG000|Outcome|Lenalidomide|Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
10920647|NCT00665652|EG000|Reported Event|Lenalidomide|Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
10920648|NCT00665704|BG000|Baseline|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
10920649|NCT00665704|FG000|Participant Flow|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
10920650|NCT00665704|OG000|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
10920651|NCT00665704|EG000|Reported Event|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
10920652|NCT00665847|BG000|Baseline|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
10920653|NCT00665847|FG000|Participant Flow|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
10920654|NCT00665847|OG000|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
10920655|NCT00665847|EG000|Reported Event|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
10920656|NCT00665925|BG000|Baseline|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
10920657|NCT00665925|BG001|Baseline|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
10920658|NCT00665925|BG002|Baseline|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
10920659|NCT00665925|BG003|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
10920660|NCT00665925|BG004|Baseline|Total|Total of all reporting groups
10920661|NCT00665925|FG000|Participant Flow|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
10920662|NCT00665925|FG001|Participant Flow|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
10920663|NCT00665925|FG002|Participant Flow|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
10920664|NCT00665925|FG003|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
10920665|NCT00665925|OG000|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
10920666|NCT00665925|OG001|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
10920667|NCT00665925|OG002|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
10920668|NCT00665925|OG003|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
10920669|NCT00665925|OG004|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
10920670|NCT00665925|EG000|Reported Event|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
10920671|NCT00665925|EG001|Reported Event|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
10920672|NCT00665925|EG002|Reported Event|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
10920673|NCT00665925|EG003|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
11234078|NCT02432183|OG001|Outcome|Basketball Players|Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.
11234079|NCT02432183|OG002|Outcome|Swimmers|Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation
10920674|NCT00666029|BG000|Baseline|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L - a cardinal lipid abnormality of the syndrome."
10920675|NCT00666029|BG001|Baseline|Placebo|"Placebo arm dummy pill~placebo: Placebo Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L - a cardinal lipid abnormality of the syndrome."
10920676|NCT00666029|BG002|Baseline|Total|Total of all reporting groups
10920677|NCT00666029|FG000|Participant Flow|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
10920678|NCT00666029|FG001|Participant Flow|Placebo|"Placebo arm dummy pill~placebo: Placebo"
10920679|NCT00666029|OG000|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months"
10920680|NCT00666029|OG001|Outcome|Placebo|"Placebo arm dummy pill~placebo: Placebo"
10920681|NCT00666029|OG000|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
10920682|NCT00666029|EG000|Reported Event|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months"
10920683|NCT00666029|EG001|Reported Event|Placebo|"Placebo arm dummy pill~placebo: Placebo"
10920684|NCT00666198|BG000|Baseline|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
10920685|NCT00666198|FG000|Participant Flow|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
10920686|NCT00666198|OG000|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
10920687|NCT00666198|EG000|Reported Event|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
10920688|NCT00666211|BG000|Baseline|Standard of Care|Standard pain control drugs.
10920689|NCT00666211|BG001|Baseline|Opioid Titration|Pain will be Monitored and Medication Titrated
10920690|NCT00666211|BG002|Baseline|Total|Total of all reporting groups
10920691|NCT00666211|FG000|Participant Flow|Standard of Care|Standard pain control drugs.
10920692|NCT00666211|FG001|Participant Flow|Opioid Titration|Pain will be Monitored and Medication Titrated
10920693|NCT00666211|OG000|Outcome|Standard of Care|Standard pain control drugs.
10920694|NCT00666211|OG001|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
10920695|NCT00666211|EG000|Reported Event|Standard of Care|Standard pain control drugs.
10920696|NCT00666211|EG001|Reported Event|Opioid Titration|Pain will be Monitored and Medication Titrated
10920697|NCT00666224|BG000|Baseline|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
10920698|NCT00666224|BG001|Baseline|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
10920699|NCT00666224|BG002|Baseline|Total|Total of all reporting groups
10920700|NCT00666224|FG000|Participant Flow|Glatiramer Acetate|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection during the double-blind period. Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Participants in this treatment arm continued taking glatiramer acetate 20 mg once daily by subcutaneous injection during the open-label (OL) period.
10920701|NCT00666224|FG001|Participant Flow|Placebo (DB) to GA (OL)|Placebo matching glatiramer acetate given once daily by subcutaneous injection during the double-blind period (DB). Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Glatiramer acetate (GA) given 20 mg once daily by subcutaneous injection during the open-label period (OL).
10920702|NCT00666224|OG000|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
10920703|NCT00666224|OG001|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
10920704|NCT00666224|EG000|Reported Event|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
10920705|NCT00666224|EG001|Reported Event|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period. This subset of the GA treatment experience allows for comparison to the Placebo Double-blind Period data.
10920706|NCT00666224|EG002|Reported Event|Glatiramer Acetate (Entire Study)|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection. GA adverse experiences from both the double-blind and open-label periods are combined in this column.
10920707|NCT00666263|BG000|Baseline|All Study Participants|Each participant was to complete 5 study parts (3 stabilization phases of open label treatment with IGIV, 10%, and 1 cross-over period each of double-blind treatment with IGIV, 10% and placebo according to a randomized sequence). Each study part lasted 12 weeks and comprised 3, 4 or 6 infusion cycles depending on treatment interval. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) for all participants Study Part 2: Participants were randomized to 1 of 2 sequences of double-blind treatment (either: IGIV, 10% or placebo) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Participants were crossed-over to second sequence of double-blind treatment (IGIV, 10% or placebo) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
11234080|NCT02432183|OG003|Outcome|Control Group|Age-matched controls are recruited (exercising at a recreational level, >4 hours).
10920708|NCT00666263|FG000|Participant Flow|IGIV, 10% Then Placebo (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
10920709|NCT00666263|FG001|Participant Flow|Placebo Then IGIV, 10% (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
10920710|NCT00666263|OG000|Outcome|Before Stabilization 1|Baseline Measurements
10920711|NCT00666263|OG001|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
10920712|NCT00666263|OG002|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
10920713|NCT00666263|OG003|Outcome|End of Stabilization 2|IGIV, 10%
10920714|NCT00666263|OG004|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
10920715|NCT00666263|OG005|Outcome|End of Stabilization 3|IGIV, 10%
10920716|NCT00666263|OG006|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
10920717|NCT00666263|OG000|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920718|NCT00666263|OG001|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920719|NCT00666263|OG002|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920720|NCT00666263|OG003|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920721|NCT00666263|OG000|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, but not after the placebo
10920722|NCT00666263|OG001|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following the placebo, but not after IGIV, 10%
10920723|NCT00666263|OG002|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
10920724|NCT00666263|OG003|Outcome|No Decline During Placebo or IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
10964037|NCT00875550|EG000|Reported Event|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
10920725|NCT00666263|OG000|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920726|NCT00666263|OG001|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920727|NCT00666263|OG002|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920728|NCT00666263|OG003|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920729|NCT00666263|OG000|Outcome|Accelerated Switch During IGIV, 10% and Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, and placebo
10920730|NCT00666263|OG001|Outcome|Accelerated Switch During Placebo, But Not IGIV, 10%|Participants who required a switch to open label IGIV, 10% when receiving the placebo, but not during IGIV, 10%
10920731|NCT00666263|OG002|Outcome|Accelerated Switch During IGIV, 10%, But Not Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, but not during placebo
10920732|NCT00666263|OG003|Outcome|No Accelerated Switch During IGIV, 10% or Placebo|Participants who did not require a switch to open label IGIV, 10% when receiving IGIV, 10%, or placebo
10920733|NCT00666263|OG000|Outcome|End of Stabilization 1|(IGIV, 10%)
10920734|NCT00666263|OG001|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
10920735|NCT00666263|OG002|Outcome|End of Stabilization 2|(IGIV, 10%)
10920736|NCT00666263|OG003|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
10920737|NCT00666263|OG004|Outcome|End of Stabilization 3|(IGIV, 10%)
10920738|NCT00666263|OG005|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
10920739|NCT00666263|OG000|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, but not after the placebo
10920740|NCT00666263|OG001|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following the placebo, but not after IGIV, 10%
10920741|NCT00666263|OG002|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
10920742|NCT00666263|OG003|Outcome|No Decline During Placebo and IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
10920743|NCT00666263|OG000|Outcome|Deterioration After IGIV, 10% and Placebo|Participants with deterioration in GNDS scores after IGIV, 10% and placebo
10920744|NCT00666263|OG001|Outcome|Deterioration After Placebo, But Not IGIV, 10%|Participants with deterioration in GNDS scores after Placebo, but not IGIV, 10%
10920745|NCT00666263|OG002|Outcome|Deterioration After IGIV, 10%, But Not Placebo|Participants with deterioration in GNDS scores after IGIV, 10%, but not Placebo
10920746|NCT00666263|OG003|Outcome|No Deterioration After IGIV, 10% or Placebo|Participants with no deterioration in GNDS scores after IGIV, 10% or Placebo
10920747|NCT00666263|OG000|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
11234081|NCT02432183|EG000|Reported Event|Football Players|Football players of the first grade of high school are recruited from the topsportschool in Leuven.
10920748|NCT00666263|OG001|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920749|NCT00666263|OG002|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920750|NCT00666263|OG003|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
10920751|NCT00666263|EG000|Reported Event|IGIV, 10%|Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)
10920752|NCT00666263|EG001|Reported Event|Placebo|0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used)
10920753|NCT00666276|BG000|Baseline|Linezolid|Participants who have been treated with Linezolid.
10920754|NCT00666276|FG000|Participant Flow|Linezolid|Participants who have been treated with Linezolid.
10920755|NCT00666276|OG000|Outcome|Linezolid|Participants who have been treated with Linezolid.
10920756|NCT00666276|OG000|Outcome|Linezolid-male|Male participants who have been treated with Linezolid.
11357601|NCT03754556|OG000|Outcome|Women With IUD|Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.
10920757|NCT00666276|OG001|Outcome|Linezolid-female|Female participants who have been treated with Linezolid.
10920758|NCT00666276|OG000|Outcome|Linezolid-over 65|Participants with over 65 years old who have been treated with Linezolid.
10920759|NCT00666276|OG001|Outcome|Linezolid-less Than 65|Participants with less than 65 years old who have been treated with Linezolid.
10920760|NCT00666276|OG000|Outcome|Linezolid-without Hepatic Dysfunctions|Participants with or without Hepatic dysfunctions who have been treated with Linezolid.
10920761|NCT00666276|OG001|Outcome|Linezolid- With Hepatic Dysfunctions|Participants with Hepatic dysfunctions who have been treated with Linezolid.
10920762|NCT00666276|OG000|Outcome|Linezolid Without Renal Dysfunctions|Participants without Renal dysfunctions who have been treated with Linezolid.
10920763|NCT00666276|OG001|Outcome|Linezolid- With Renal Dysfunctions|Participants with Renal dysfunctions who have been treated with Linezolid.
10920764|NCT00666276|OG000|Outcome|Linezolid-administrated Over 15 Days|Participants who have been treated with Linezolid.with Duration of drug administration over 15 days
10920765|NCT00666276|OG001|Outcome|Linezolid-administrated Less Than 15 Days|Participants with who have been treated with Linezolid.with Duration of drug administration less than 15 days
10920766|NCT00666276|OG000|Outcome|Linezolid-oral|Participants with who have been orally treated with Linezolid.
10920767|NCT00666276|OG001|Outcome|Linezolid-injection|Participants with who have been treated with Linezolid by injection.
10920768|NCT00666276|OG002|Outcome|Linezolid-oral From Injection|Participants with who have been treated with Linezolid by orally from injection .
10920769|NCT00666276|OG000|Outcome|Linezolid -Over 40kg|Participants over 40kg who have been treated with Linezolid.
10920770|NCT00666276|OG001|Outcome|Linezolid -Less Than 40kg|Participants less than 40kg who have been treated with Linezolid.
10920771|NCT00666276|OG000|Outcome|Linezolid-without Concomitant Drugs|Participants without Concomitant drugs who have been treated with Linezolid.
10920772|NCT00666276|OG001|Outcome|Linezolid-with Concomitant Drugs|Participants with Concomitant drugs who have been treated with Linezolid.
10920773|NCT00666276|OG000|Outcome|Linezolid-without Non-drug Therapies|Participants without Non-drug therapies who have been treated with Linezolid.
10920774|NCT00666276|OG001|Outcome|Linezolid-with Non-drug Therapies|Participants with Non-drug therapies who have been treated with Linezolid.
10920775|NCT00666276|EG000|Reported Event|Linezolid|Participants who have been treated with Linezolid.
10920776|NCT00666328|BG000|Baseline|Clevidipine|"mITT (Modified Intent To Treat) Population (n=33): This population is the primary population for the efficacy analyses.~Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
11234082|NCT02432183|EG001|Reported Event|Swimmers|Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation
10920777|NCT00666328|FG000|Participant Flow|Clevidipine|Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours.
10920778|NCT00666328|OG000|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
10920779|NCT00666328|OG000|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for 30 minutes to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.
10920780|NCT00666328|OG000|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours
10920781|NCT00666328|EG000|Reported Event|Clevidipine|"Safety Population (n=35): This population is the primary population for the safety analyses.~Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
10920782|NCT00666406|BG000|Baseline|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
10920783|NCT00666406|FG000|Participant Flow|Advate rAHF-PFM Then Recombinate rAHF|First infusion - Advate Antihemophilic Factor (Recombinant)-Plasma/Albumin Free Method (rAHF-PFM): Infusion of 50 +/- 5 IU/kg bodyweight Second infusion - Recombinate Antihemophilic Factor (Recombinant) (rAHF): Infusion of 50 +/- 5 IU/kg bodyweight
10920784|NCT00666406|FG001|Participant Flow|Recombinate rAHF Then Advate rAHF-PFM|First infusion - Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight Second infusion - Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
10920785|NCT00666406|OG000|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
10920786|NCT00666406|OG001|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
10920787|NCT00666406|EG000|Reported Event|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
10920788|NCT00666458|BG000|Baseline|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
10920789|NCT00666458|BG001|Baseline|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
10920790|NCT00666458|BG002|Baseline|Total|Total of all reporting groups
10920791|NCT00666458|FG000|Participant Flow|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
10920792|NCT00666458|FG001|Participant Flow|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
10920793|NCT00666458|OG000|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
10920794|NCT00666458|OG001|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
10920795|NCT00666458|EG000|Reported Event|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
10920796|NCT00666458|EG001|Reported Event|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
10920797|NCT00666536|BG000|Baseline|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
10920798|NCT00666536|BG001|Baseline|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
10920799|NCT00666536|BG002|Baseline|Total|Total of all reporting groups
10920800|NCT00666536|FG000|Participant Flow|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
10920801|NCT00666536|FG001|Participant Flow|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
10920802|NCT00666536|OG000|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
10920803|NCT00666536|OG001|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
11234083|NCT02432183|EG002|Reported Event|Basketball Players|Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.
10920804|NCT00666536|EG000|Reported Event|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
10920805|NCT00666536|EG001|Reported Event|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
10920806|NCT00666562|BG000|Baseline|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920807|NCT00666562|BG001|Baseline|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920808|NCT00666562|BG002|Baseline|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920809|NCT00666562|BG003|Baseline|Total|Total of all reporting groups
10920810|NCT00666562|FG000|Participant Flow|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920811|NCT00666562|FG001|Participant Flow|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920812|NCT00666562|FG002|Participant Flow|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920813|NCT00666562|OG000|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920814|NCT00666562|OG001|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920815|NCT00666562|OG002|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920816|NCT00666562|OG000|Outcome|Glycine/Glycine|G to G transition in the COMT gene
10920817|NCT00666562|OG001|Outcome|Alanine/Glycine|A to G transition in the COMT gene
10920818|NCT00666562|OG002|Outcome|Alanine/Alanine|A to A transition in the COMT gene
10920819|NCT00666562|OG000|Outcome|5/6 Genotype|Genotype of the UGT in EGCG
10920820|NCT00666562|OG001|Outcome|6/6 Genotype|Genotype of the UGT in EGCG
10920821|NCT00666562|OG002|Outcome|6/7 Genotype|Genotype of the UGT in EGCG
10920822|NCT00666562|OG003|Outcome|7/7 Genotype|Genotype of the UGT in EGCG
10920823|NCT00666562|EG000|Reported Event|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920824|NCT00666562|EG001|Reported Event|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10920825|NCT00666562|EG002|Reported Event|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10964038|NCT00875550|EG001|Reported Event|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
10920826|NCT00666588|BG000|Baseline|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
10920827|NCT00666588|BG001|Baseline|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920828|NCT00666588|BG002|Baseline|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920829|NCT00666588|BG003|Baseline|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920830|NCT00666588|BG004|Baseline|Total|Total of all reporting groups
10920831|NCT00666588|FG000|Participant Flow|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
10920832|NCT00666588|FG001|Participant Flow|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920833|NCT00666588|FG002|Participant Flow|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920834|NCT00666588|FG003|Participant Flow|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920835|NCT00666588|OG000|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
11234084|NCT02432183|EG003|Reported Event|Control Group|Age-matched controls are recruited (exercising at a recreational level, >4 hours).
10920836|NCT00666588|OG001|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920837|NCT00666588|OG002|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920838|NCT00666588|OG003|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920839|NCT00666588|EG000|Reported Event|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
10920840|NCT00666588|EG001|Reported Event|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920841|NCT00666588|EG002|Reported Event|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920842|NCT00666588|EG003|Reported Event|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10920843|NCT00666666|BG000|Baseline|AT101 (R-(-)-Gossypol Acetic Acid)|
10920844|NCT00666666|FG000|Participant Flow|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
10964039|NCT00875563|BG000|Baseline|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
11175003|NCT02026141|EG000|Reported Event|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
11234085|NCT02432235|BG000|Baseline|3 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10920845|NCT00666666|OG000|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
10920846|NCT00666666|EG000|Reported Event|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
10920847|NCT00666679|BG000|Baseline|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
10920848|NCT00666679|BG001|Baseline|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
10920849|NCT00666679|BG002|Baseline|Total|Total of all reporting groups
10920850|NCT00666679|FG000|Participant Flow|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
10920851|NCT00666679|FG001|Participant Flow|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
10920852|NCT00666679|OG000|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
10920853|NCT00666679|OG001|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
10920854|NCT00666679|EG000|Reported Event|Montelukast + Mometasone|Inhaled montelukast 1 mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
10920855|NCT00666679|EG001|Reported Event|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
10920856|NCT00666705|BG000|Baseline|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:~Days 1-3: raltegravir 400 mg every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
10920857|NCT00666705|FG000|Participant Flow|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:~Days 1-3: raltegravir 400 milligrams (mg) every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
10920858|NCT00666705|OG000|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
10920859|NCT00666705|OG001|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
10920860|NCT00666705|OG000|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
11175004|NCT02026141|EG001|Reported Event|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
10920861|NCT00666705|OG001|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
10920862|NCT00666705|EG000|Reported Event|Maraviroc|300 milligrams (mg) every 12 hours on Study Days 6-11
10920863|NCT00666705|EG001|Reported Event|Maraviroc + Raltegravir|On Study Days 12-14: Raltegravir 400 milligrams (mg) every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
10920864|NCT00666705|EG002|Reported Event|Raltegravir|400 milligrams (mg) every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
10920865|NCT00666718|BG000|Baseline|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
10920866|NCT00666718|BG001|Baseline|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
10920867|NCT00666718|BG002|Baseline|Total|Total of all reporting groups
10920868|NCT00666718|FG000|Participant Flow|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
10920869|NCT00666718|FG001|Participant Flow|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
10920870|NCT00666718|OG000|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
10920871|NCT00666718|OG001|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
10920872|NCT00666718|EG000|Reported Event|Glargine/Lispro|Glargine plus Insulin Lispro (2-3 injections) plus metformin
10920873|NCT00666718|EG001|Reported Event|Lispro/Metformin|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
10920874|NCT00666757|BG000|Baseline|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
10920875|NCT00666757|BG001|Baseline|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
10920876|NCT00666757|BG002|Baseline|Total|Total of all reporting groups
10920877|NCT00666757|FG000|Participant Flow|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
10920878|NCT00666757|FG001|Participant Flow|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
10920879|NCT00666757|OG000|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
10920880|NCT00666757|OG001|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
10920881|NCT00666757|EG000|Reported Event|Duloxetine|30-120 mg orally daily for 12 weeks
11175005|NCT02026193|BG000|Baseline|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
11175006|NCT02026193|BG001|Baseline|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
10920882|NCT00666757|EG001|Reported Event|Citalopram|20-40 mg orally daily for 12 weeks
10920883|NCT00666757|EG002|Reported Event|Fluoxetine|20-80 mg orally daily for 12 weeks
10920884|NCT00666757|EG003|Reported Event|Paroxetine|20-50 mg orally daily for 12 weeks
10920885|NCT00666757|EG004|Reported Event|Sertraline|50-200 mg orally daily for 12 weeks
10920886|NCT00666835|BG000|Baseline|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
10920887|NCT00666835|BG001|Baseline|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag intravenously in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
10920888|NCT00666835|BG002|Baseline|Total|Total of all reporting groups
10920889|NCT00666835|FG000|Participant Flow|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to epoetin alfa HX575 Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
10920890|NCT00666835|FG001|Participant Flow|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated intravenously with ERYPO®, Janssen-Cilag in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
10920891|NCT00666835|OG000|Outcome|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
10920892|NCT00666835|OG001|Outcome|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO®, Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
10920893|NCT00666835|OG001|Outcome|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated intravenously with ERYPO® Janssen-Cilag in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
10920894|NCT00666835|EG000|Reported Event|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1 to be intravenously (solution for injection i.v.) treated with HX575 in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
11175007|NCT02026193|BG002|Baseline|Total|Total of all reporting groups
11175008|NCT02026193|FG000|Participant Flow|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
11175009|NCT02026193|FG001|Participant Flow|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
11175010|NCT02026193|OG000|Outcome|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
11175011|NCT02026193|OG001|Outcome|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
11175012|NCT02026193|EG000|Reported Event|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
10920895|NCT00666835|EG001|Reported Event|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO®, Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
10920896|NCT00666848|BG000|Baseline|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
10920897|NCT00666848|BG001|Baseline|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
10920898|NCT00666848|BG002|Baseline|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
10920899|NCT00666848|BG003|Baseline|Total|Total of all reporting groups
10920900|NCT00666848|FG000|Participant Flow|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
10920901|NCT00666848|FG001|Participant Flow|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
10920902|NCT00666848|FG002|Participant Flow|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
11175013|NCT02026193|EG001|Reported Event|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
10920903|NCT00666848|OG000|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
10920904|NCT00666848|OG001|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
10920905|NCT00666848|OG002|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
10920906|NCT00666848|EG000|Reported Event|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
10920907|NCT00666848|EG001|Reported Event|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
10920908|NCT00666848|EG002|Reported Event|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
10920909|NCT00666926|BG000|Baseline|Entire Study Population|PF-00562271 dose escalation administered as 5 mg PO BID up to 150 mg PO BID or 125 mg PO QD up to 225 mg PO QD. Participants in the PF-00562271125 mg BID US E1 cohort administered MDZ 2 mg/mL as a single dose on C1.D1 and C1.D21 prior to PF-00562271 dosing.
10920910|NCT00666926|FG000|Participant Flow|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
10920911|NCT00666926|FG001|Participant Flow|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
10920912|NCT00666926|FG002|Participant Flow|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
10920913|NCT00666926|FG003|Participant Flow|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
10920914|NCT00666926|FG004|Participant Flow|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
10920915|NCT00666926|FG005|Participant Flow|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
10920916|NCT00666926|FG006|Participant Flow|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
10920917|NCT00666926|FG007|Participant Flow|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).~As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
10920918|NCT00666926|FG008|Participant Flow|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
10920919|NCT00666926|FG009|Participant Flow|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
10920920|NCT00666926|FG010|Participant Flow|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
10964040|NCT00875563|FG000|Participant Flow|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
10964041|NCT00875563|OG000|Outcome|Zenith® Fenestrated AAA Endovascular Graft|
11234086|NCT02432235|BG001|Baseline|5 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10920921|NCT00666926|FG011|Participant Flow|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 (C1.D21) simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.~Escalation and expansion cohorts were combined for reporting."
10920922|NCT00666926|FG012|Participant Flow|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
10920923|NCT00666926|FG013|Participant Flow|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
10920924|NCT00666926|FG014|Participant Flow|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
10920925|NCT00666926|FG015|Participant Flow|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
10920926|NCT00666926|OG000|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
10920927|NCT00666926|OG001|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
10920928|NCT00666926|OG002|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
10920929|NCT00666926|OG003|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
10920930|NCT00666926|OG004|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
10920931|NCT00666926|OG005|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
10920932|NCT00666926|OG006|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
10920933|NCT00666926|OG007|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
10920934|NCT00666926|OG008|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
10920935|NCT00666926|OG009|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
10920936|NCT00666926|OG010|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
10920937|NCT00666926|OG011|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
10920938|NCT00666926|OG012|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
10920939|NCT00666926|OG013|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
10920940|NCT00666926|OG014|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
10920941|NCT00666926|OG015|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
10920942|NCT00666926|OG000|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
10920943|NCT00666926|OG007|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
10920944|NCT00666926|OG008|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
10920945|NCT00666926|OG009|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
10920946|NCT00666926|OG010|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
10920947|NCT00666926|OG011|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
10920948|NCT00666926|OG012|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
10920949|NCT00666926|OG013|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
10920950|NCT00666926|OG014|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
10920951|NCT00666926|OG015|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
10920952|NCT00666926|OG016|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
10920953|NCT00666926|OG017|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
10920954|NCT00666926|OG010|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
10920955|NCT00666926|OG008|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
10920956|NCT00666926|OG011|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
10920957|NCT00666926|OG012|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
10920958|NCT00666926|OG013|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
10920959|NCT00666926|EG000|Reported Event|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
10920960|NCT00666926|EG001|Reported Event|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
10920961|NCT00666926|EG002|Reported Event|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
10920962|NCT00666926|EG003|Reported Event|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
10920963|NCT00666926|EG004|Reported Event|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
10920964|NCT00666926|EG005|Reported Event|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
10920965|NCT00666926|EG006|Reported Event|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
10920966|NCT00666926|EG007|Reported Event|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).~As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
10920967|NCT00666926|EG008|Reported Event|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
10920968|NCT00666926|EG009|Reported Event|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
10920969|NCT00666926|EG010|Reported Event|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
10963206|NCT00870870|BG000|Baseline|Gemcitabine/Carboplatin/Cetuximab (GCC)|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10920970|NCT00666926|EG011|Reported Event|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.~Escalation and expansion cohorts were combined for reporting."
10920971|NCT00666926|EG012|Reported Event|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
10920972|NCT00666926|EG013|Reported Event|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
10920973|NCT00666926|EG014|Reported Event|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
10920974|NCT00666926|EG015|Reported Event|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
10920975|NCT00666965|BG000|Baseline|Placebo|placebo transdermal patch
10920976|NCT00666965|BG001|Baseline|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
10920977|NCT00666965|BG002|Baseline|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
10920978|NCT00666965|BG003|Baseline|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
10920979|NCT00666965|BG004|Baseline|Total|Total of all reporting groups
10920980|NCT00666965|FG000|Participant Flow|Placebo|placebo transdermal patch
10920981|NCT00666965|FG001|Participant Flow|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
10920982|NCT00666965|FG002|Participant Flow|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
10920983|NCT00666965|FG003|Participant Flow|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
10920984|NCT00666965|OG000|Outcome|Placebo|placebo transdermal patch
10920985|NCT00666965|OG001|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
10920986|NCT00666965|OG002|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
10920987|NCT00666965|OG003|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
11234087|NCT02432235|BG002|Baseline|8 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10920988|NCT00666965|EG000|Reported Event|Placebo|placebo transdermal patch
10920989|NCT00666965|EG001|Reported Event|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
10920990|NCT00666965|EG002|Reported Event|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
10920991|NCT00666965|EG003|Reported Event|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
10920992|NCT00666978|BG000|Baseline|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
10920993|NCT00666978|BG001|Baseline|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
10920994|NCT00666978|BG002|Baseline|Total|Total of all reporting groups
10920995|NCT00666978|FG000|Participant Flow|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
10920996|NCT00666978|FG001|Participant Flow|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
10920997|NCT00666978|OG000|Outcome|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
10920998|NCT00666978|OG001|Outcome|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
10920999|NCT00666978|OG000|Outcome|All Study Participants|All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
10921000|NCT00666978|OG000|Outcome|Bupropion Arm|270 African American adults received bupropion (150mg bid)for 7 weeks in addition to health education counseling.
10921001|NCT00666978|EG000|Reported Event|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
10921002|NCT00666978|EG001|Reported Event|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
10921003|NCT00667004|BG000|Baseline|Ecabet Ophthalmic Solution|"ecabet ophthalmic solution~ecabet ophthalmic solution: sterile ophthalmic solution"
10921004|NCT00667004|BG001|Baseline|Vehicle|"Placebo comparator~placebo: sterile ophthalmic solution"
10921005|NCT00667004|BG002|Baseline|Total|Total of all reporting groups
10921006|NCT00667004|FG000|Participant Flow|Ecabet Ophthalmic Solution|"ecabet ophthalmic solution~ecabet ophthalmic solution: sterile ophthalmic solution"
10921007|NCT00667004|FG001|Participant Flow|Vehicle|"Placebo comparator~placebo: sterile ophthalmic solution"
10921008|NCT00667004|OG000|Outcome|Ecabet Ophthalmic Solution|"ecabet ophthalmic solution~ecabet ophthalmic solution: sterile ophthalmic solution"
10921009|NCT00667004|OG001|Outcome|Vehicle|"Placebo comparator~placebo: sterile ophthalmic solution"
10921010|NCT00667004|EG000|Reported Event|Ecabet Ophthalmic Solution|"ecabet ophthalmic solution~ecabet ophthalmic solution: sterile ophthalmic solution"
10921011|NCT00667004|EG001|Reported Event|Vehicle|"Placebo comparator~placebo: sterile ophthalmic solution"
10921012|NCT00667095|BG000|Baseline|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
11234088|NCT02432235|BG003|Baseline|13 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921013|NCT00667095|BG001|Baseline|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
10921014|NCT00667095|BG002|Baseline|Total|Total of all reporting groups
10921015|NCT00667095|FG000|Participant Flow|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
10921016|NCT00667095|FG001|Participant Flow|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
10921017|NCT00667095|OG000|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
10921018|NCT00667095|OG001|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
10921019|NCT00667095|EG000|Reported Event|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
10921020|NCT00667095|EG001|Reported Event|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
10921021|NCT00667186|BG000|Baseline|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
10921022|NCT00667186|BG001|Baseline|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
10921023|NCT00667186|BG002|Baseline|Total|Total of all reporting groups
10921024|NCT00667186|FG000|Participant Flow|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
10921025|NCT00667186|FG001|Participant Flow|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
10921026|NCT00667186|OG000|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
10921027|NCT00667186|OG001|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
10921028|NCT00667186|EG000|Reported Event|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
10921029|NCT00667186|EG001|Reported Event|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
10964042|NCT00875563|EG000|Reported Event|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
10964043|NCT00875589|BG000|Baseline|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
11175014|NCT02026206|BG000|Baseline|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
11175015|NCT02026206|BG001|Baseline|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
11175016|NCT02026206|BG002|Baseline|Total|Total of all reporting groups
10921030|NCT00667225|BG000|Baseline|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
10921031|NCT00667225|BG001|Baseline|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
10921032|NCT00667225|BG002|Baseline|Total|Total of all reporting groups
11175017|NCT02026206|FG000|Participant Flow|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
11175018|NCT02026206|FG001|Participant Flow|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
11175019|NCT02026206|OG000|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
11175020|NCT02026206|OG001|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
10921033|NCT00667225|FG000|Participant Flow|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
10921034|NCT00667225|FG001|Participant Flow|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
11175021|NCT02026206|EG000|Reported Event|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
11175022|NCT02026206|EG001|Reported Event|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
11191901|NCT02135094|FG001|Participant Flow|Placebo Ultrasound Therapy Device|"Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound."
10964044|NCT00875589|BG001|Baseline|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
10964045|NCT00875589|BG002|Baseline|Total|Total of all reporting groups
10921035|NCT00667225|OG000|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
10921036|NCT00667225|OG001|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
10921037|NCT00667225|EG000|Reported Event|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
10921038|NCT00667225|EG001|Reported Event|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
10921039|NCT00667277|BG000|Baseline|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
10921040|NCT00667277|FG000|Participant Flow|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
10921041|NCT00667277|OG000|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
10921042|NCT00667277|EG000|Reported Event|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
10921043|NCT00667342|BG000|Baseline|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
10921044|NCT00667342|BG001|Baseline|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
10921045|NCT00667342|BG002|Baseline|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
10921046|NCT00667342|BG003|Baseline|Total|Total of all reporting groups
11175023|NCT02026258|BG000|Baseline|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
10921047|NCT00667342|FG000|Participant Flow|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
10921048|NCT00667342|FG001|Participant Flow|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
10921049|NCT00667342|FG002|Participant Flow|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
10921050|NCT00667342|OG000|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
10921051|NCT00667342|OG001|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
10921052|NCT00667342|OG000|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
10921053|NCT00667342|OG000|Outcome|All Participants|All the 42 evaluable participants in this study had osteosarcoma, of which 22 had events and 20 had no event.
10921054|NCT00667342|OG000|Outcome|All Participants|All 42 evaluable participants were included in this analysis
10921055|NCT00667342|OG000|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
10921056|NCT00667342|OG000|Outcome|All Participants|Thirty-two participants with osteosarcoma were evaluated in this study. The analysis for this outcome measure included 23 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 8 Stratum C participants who had metastatic tumors.
10921057|NCT00667342|OG000|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
10921058|NCT00667342|OG001|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
10921059|NCT00667342|OG002|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
10921060|NCT00667342|EG000|Reported Event|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
10921061|NCT00667342|EG001|Reported Event|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
10921062|NCT00667355|BG000|Baseline|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
11175024|NCT02026258|BG001|Baseline|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
11175025|NCT02026258|BG002|Baseline|Total|Total of all reporting groups
11175026|NCT02026258|FG000|Participant Flow|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
11175027|NCT02026258|FG001|Participant Flow|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. Time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The de"
11175028|NCT02026258|OG000|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
10921063|NCT00667355|FG000|Participant Flow|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
10921064|NCT00667355|OG000|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
10921065|NCT00667355|EG000|Reported Event|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
10921066|NCT00667368|BG000|Baseline|Control|Bi-monthly testing for BV without treatment.
10921067|NCT00667368|BG001|Baseline|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
10921068|NCT00667368|BG002|Baseline|Total|Total of all reporting groups
10921069|NCT00667368|FG000|Participant Flow|Control|Bi-monthly testing for BV without treatment.
10921070|NCT00667368|FG001|Participant Flow|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
10921071|NCT00667368|OG000|Outcome|Control|Bi-monthly testing for BV without treatment.
10921072|NCT00667368|OG001|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
10921073|NCT00667368|EG000|Reported Event|Control|Bi-monthly testing for BV without treatment.
10921074|NCT00667368|EG001|Reported Event|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
10921075|NCT00667381|BG000|Baseline|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
10921076|NCT00667381|BG001|Baseline|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
10921077|NCT00667381|BG002|Baseline|Total|Total of all reporting groups
10964046|NCT00875589|FG000|Participant Flow|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
10921078|NCT00667381|FG000|Participant Flow|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
10921079|NCT00667381|FG001|Participant Flow|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
10921080|NCT00667381|OG000|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
10921081|NCT00667381|OG001|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
11175029|NCT02026258|OG001|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
11175030|NCT02026258|OG000|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
11175031|NCT02026258|EG000|Reported Event|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
11191902|NCT02135094|OG000|Outcome|Active Ultrasound Therapy Device|"Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity~Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day"
10921082|NCT00667381|EG000|Reported Event|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
10921083|NCT00667381|EG001|Reported Event|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
10921084|NCT00667394|BG000|Baseline|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
10921085|NCT00667394|BG001|Baseline|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
10921086|NCT00667394|BG002|Baseline|Total|Total of all reporting groups
10921087|NCT00667394|FG000|Participant Flow|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
10921088|NCT00667394|FG001|Participant Flow|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
10921089|NCT00667394|OG000|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
10921090|NCT00667394|OG001|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
10921091|NCT00667394|EG000|Reported Event|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
10921092|NCT00667394|EG001|Reported Event|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
10921093|NCT00667420|BG000|Baseline|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
10921094|NCT00667420|FG000|Participant Flow|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
10921095|NCT00667420|OG000|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
10921096|NCT00667420|OG000|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
10921097|NCT00667420|EG000|Reported Event|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
10921098|NCT00667446|BG000|Baseline|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
10921099|NCT00667446|BG001|Baseline|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
10921100|NCT00667446|BG002|Baseline|Total|Total of all reporting groups
10921101|NCT00667446|FG000|Participant Flow|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
10921102|NCT00667446|FG001|Participant Flow|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
10921103|NCT00667446|OG000|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
10921104|NCT00667446|OG001|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
11191903|NCT02135094|OG001|Outcome|Placebo Ultrasound Therapy Device|"Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound."
10921105|NCT00667446|EG000|Reported Event|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
10921106|NCT00667446|EG001|Reported Event|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
10921107|NCT00667459|BG000|Baseline|Investigational|PRESTIGE® LP Cervical Disc
10921108|NCT00667459|BG001|Baseline|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
10921109|NCT00667459|BG002|Baseline|Total|Total of all reporting groups
10921110|NCT00667459|FG000|Participant Flow|Investigational|PRESTIGE® LP Cervical Disc
10921111|NCT00667459|FG001|Participant Flow|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876)
10921112|NCT00667459|OG000|Outcome|Investigational|PRESTIGE® LP Cervical Disc
10921113|NCT00667459|OG001|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
10921114|NCT00667459|EG000|Reported Event|Investigational|PRESTIGE® LP Cervical Disc
10921115|NCT00667459|EG001|Reported Event|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
10921116|NCT00667511|BG000|Baseline|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.~Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period."
10921117|NCT00667511|FG000|Participant Flow|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.~Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period.~In this prospective, two treatment, cross-over study, 58 End Stage Renal Disease patients >18 years of age who were currently stable on home DHD were enrolled. Enrolled patients performed Intervention 1 as the first phase of the cross-over study. Fifty-one patients completed Intervention 1 and seven patients dropped out. Forty-three patients completed the training/transition period and performed Intervention 2 as the second phase of the cross-over study. Thirty-nine patients completed Intervention 2 and four patients dropped out."
10921118|NCT00667511|OG000|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
10921119|NCT00667511|OG001|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
10921120|NCT00667511|EG000|Reported Event|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
10921121|NCT00667511|EG001|Reported Event|Nocturnal Home Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
10963207|NCT00870870|BG001|Baseline|GCC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10964047|NCT00875589|FG001|Participant Flow|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
11234089|NCT02432235|BG004|Baseline|20 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921122|NCT00667563|BG000|Baseline|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
10921123|NCT00667563|FG000|Participant Flow|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
10921124|NCT00667563|OG000|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
10921125|NCT00667563|EG000|Reported Event|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
10921126|NCT00667576|BG000|Baseline|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
10921127|NCT00667576|BG001|Baseline|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
10921128|NCT00667576|BG002|Baseline|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
10921129|NCT00667576|BG003|Baseline|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
10921130|NCT00667576|BG004|Baseline|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
11175032|NCT02026258|EG001|Reported Event|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone."
10921131|NCT00667576|BG005|Baseline|Total|Total of all reporting groups
10921132|NCT00667576|FG000|Participant Flow|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
10921133|NCT00667576|FG001|Participant Flow|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
10921134|NCT00667576|FG002|Participant Flow|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
10921135|NCT00667576|FG003|Participant Flow|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
10921136|NCT00667576|FG004|Participant Flow|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
10921137|NCT00667576|OG000|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
10921138|NCT00667576|OG001|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
10921139|NCT00667576|OG002|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
10921140|NCT00667576|OG003|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
10921141|NCT00667576|OG004|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
10921142|NCT00667576|EG000|Reported Event|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
10921143|NCT00667576|EG001|Reported Event|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
10921144|NCT00667576|EG002|Reported Event|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
10921145|NCT00667576|EG003|Reported Event|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
10921146|NCT00667576|EG004|Reported Event|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
10921147|NCT00667589|BG000|Baseline|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
10921148|NCT00667589|BG001|Baseline|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
10921149|NCT00667589|BG002|Baseline|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
10921150|NCT00667589|BG003|Baseline|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
10921151|NCT00667589|BG004|Baseline|Total|Total of all reporting groups
10921152|NCT00667589|FG000|Participant Flow|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
10921153|NCT00667589|FG001|Participant Flow|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
10921154|NCT00667589|FG002|Participant Flow|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
10921155|NCT00667589|FG003|Participant Flow|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
10921156|NCT00667589|OG000|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
10921157|NCT00667589|OG000|Outcome|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
10921158|NCT00667589|OG001|Outcome|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
10921159|NCT00667589|OG002|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
10921160|NCT00667589|EG000|Reported Event|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
10921161|NCT00667589|EG001|Reported Event|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
10921162|NCT00667589|EG002|Reported Event|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
10921163|NCT00667589|EG003|Reported Event|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
10921164|NCT00667602|BG000|Baseline|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921165|NCT00667602|BG001|Baseline|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921166|NCT00667602|BG002|Baseline|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921167|NCT00667602|BG003|Baseline|Total|Total of all reporting groups
10921168|NCT00667602|FG000|Participant Flow|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921169|NCT00667602|FG001|Participant Flow|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921170|NCT00667602|FG002|Participant Flow|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921171|NCT00667602|OG000|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921172|NCT00667602|OG001|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921173|NCT00667602|OG000|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921174|NCT00667602|OG000|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921175|NCT00667602|OG001|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and concomitant dose of PCV7 and DTPa-IPV-HepBHib at 12 months.
10921176|NCT00667602|OG002|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921177|NCT00667602|OG001|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921178|NCT00667602|OG002|Outcome|MenC(1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921179|NCT00667602|EG000|Reported Event|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921180|NCT00667602|EG001|Reported Event|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921181|NCT00667602|EG002|Reported Event|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
10921182|NCT00667615|BG000|Baseline|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
10921183|NCT00667615|FG000|Participant Flow|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
10921184|NCT00667615|OG000|Outcome|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
10921185|NCT00667615|EG000|Reported Event|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
10921186|NCT00667693|BG000|Baseline|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
10921187|NCT00667693|BG001|Baseline|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
10921188|NCT00667693|BG002|Baseline|Total|Total of all reporting groups
10921189|NCT00667693|FG000|Participant Flow|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
10921190|NCT00667693|FG001|Participant Flow|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
10921191|NCT00667693|OG000|Outcome|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
10921192|NCT00667693|OG001|Outcome|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
10921193|NCT00667693|EG000|Reported Event|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
10921194|NCT00667693|EG001|Reported Event|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
10921195|NCT00667719|BG000|Baseline|Aliskiren /Amlodipine/Hydrochlorothiazide|Participants received aliskiren 300 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
10921196|NCT00667719|FG000|Participant Flow|Aliskiren /Amlodipine/Hydrochlorothiazide|Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
10921197|NCT00667719|OG000|Outcome|Aliskiren/Hydrochlorothiazide 300/12.5 mg|Participants received aliskiren 300 mg plus hydrochlorothiazide 12.5 mg, orally with water, once daily in the morning, for one week, at Week 1.
10921198|NCT00667719|OG001|Outcome|Aliskiren/Amlodipine/Hydrochlorothiazide 300/5/12.5 mg|Following Week 1, participants received combination of aliskiren 300 mg plus amolodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. All study medications were taken orally with water, once daily in the morning.
10921199|NCT00667719|OG002|Outcome|Aliskiren/Amlodipine/Hydrochlorothiazide 300/10/25 mg|Following Week 2, participants were force titrated up to aliskiren 300 mg plus amolodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
10921200|NCT00667719|OG000|Outcome|Aliskiren/Amlodipine/Hydrochlorothiazide|Participants received aliskiren 300 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
10921201|NCT00667719|EG000|Reported Event|Aliskiren/Hydrochlorothiazide 300/12.5 mg|Participants received aliskiren 300 mg plus hydrochlorothiazide 12.5 mg, orally with water, once daily in the morning, for one week, at Week 1.
10921202|NCT00667719|EG001|Reported Event|Aliskiren/Amlodipine/Hydrochlorothiazide 300/5/12.5 mg|Following Week 1, participants received combination of aliskiren 300 mg plus amolodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. All study medications were taken orally with water, once daily in the morning.
11175033|NCT02026297|BG000|Baseline|Control, Low Risk PPH|"Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.~Placebo; Normal Saline: 0.9% Normal Saline"
10921203|NCT00667719|EG002|Reported Event|Aliskiren/Amlodipine/Hydrochlorothiazide 300/10/25 mg|Following Week 2, participants were force titrated up to aliskiren 300 mg plus amolodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
10921204|NCT00667732|BG000|Baseline|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
10921205|NCT00667732|BG001|Baseline|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
10921206|NCT00667732|BG002|Baseline|Total|Total of all reporting groups
10921207|NCT00667732|FG000|Participant Flow|Run-In Group|"All participants took exenatide twice daily in addition to their Metformin dose.~A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time."
10921208|NCT00667732|FG001|Participant Flow|Exenatide Group|"After run-in participants were randomized to exenatide.~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks~metformin: continued at same dose participant entered study on.~Lantus Insulin: titrated per protocol depending on blood sugar levels~In extension period, participants continued regular regimen with open label exenatide"
10921209|NCT00667732|FG002|Participant Flow|Placebo Group|"After run-in participants were randomized to placebo.~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks~metformin: continued at same dose participant entered study on.~Lantus Insulin: titrated per protocol depending on blood sugar levels~In extension period, participants continued regular regimen with open label exenatide instead of placebo"
10921210|NCT00667732|OG000|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
10921211|NCT00667732|OG001|Outcome|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
10921212|NCT00667732|OG001|Outcome|Placebo Group|
10921213|NCT00667732|EG000|Reported Event|Run-In Group|All participants took exenatide twice daily in addition to their Metformin dose.
10921214|NCT00667732|EG001|Reported Event|Exenatide Randomization Group|After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
11175034|NCT02026297|BG001|Baseline|Treated, Low Risk PPH|"Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.~Tranexamic Acid: 1 gram IV over 10 minutes"
11175035|NCT02026297|BG002|Baseline|Total|Total of all reporting groups
11175036|NCT02026297|FG000|Participant Flow|Control, Low Risk PPH|"Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.~Placebo; Normal Saline: 0.9% Normal Saline"
11175037|NCT02026297|FG001|Participant Flow|Treated, Low Risk PPH|"Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.~Tranexamic Acid: 1 gram IV over 10 minutes"
11175038|NCT02026297|OG000|Outcome|Control, Low Risk PPH|"Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.~Placebo; Normal Saline: 0.9% Normal Saline"
10921215|NCT00667732|EG002|Reported Event|Placebo Randomization Period|After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
10921216|NCT00667732|EG003|Reported Event|Exenatide Open-Label (Previous Exenatide)|Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
10921217|NCT00667732|EG004|Reported Event|Exenatide Open-Label (Previous Placebo)|Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
10921218|NCT00667745|BG000|Baseline|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10921219|NCT00667745|BG001|Baseline|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10921220|NCT00667745|BG002|Baseline|Total|Total of all reporting groups
10921221|NCT00667745|FG000|Participant Flow|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10921222|NCT00667745|FG001|Participant Flow|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10921223|NCT00667745|OG000|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10921224|NCT00667745|OG001|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10921225|NCT00667745|OG000|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed. Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10921226|NCT00667745|EG000|Reported Event|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10921227|NCT00667745|EG001|Reported Event|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
10964048|NCT00875589|OG000|Outcome|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
10921228|NCT00667810|BG000|Baseline|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921229|NCT00667810|BG001|Baseline|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921230|NCT00667810|BG002|Baseline|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921231|NCT00667810|BG003|Baseline|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921232|NCT00667810|BG004|Baseline|Total|Total of all reporting groups
10921233|NCT00667810|FG000|Participant Flow|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by intravenous (IV) infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921234|NCT00667810|FG001|Participant Flow|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921235|NCT00667810|FG002|Participant Flow|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921236|NCT00667810|FG003|Participant Flow|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921237|NCT00667810|OG000|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921238|NCT00667810|OG001|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921239|NCT00667810|OG002|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921240|NCT00667810|OG003|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined to form the Pooled Bapineuzumab group.
10921241|NCT00667810|OG003|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined
10921242|NCT00667810|OG000|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
10921243|NCT00667810|OG001|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
10921244|NCT00667810|OG000|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the DAD total score, results are presented from a REML-based MMRM.
10921245|NCT00667810|OG001|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the DAD total score, results are presented from a REML)-based MMRM.
10921246|NCT00667810|EG000|Reported Event|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921247|NCT00667810|EG001|Reported Event|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921248|NCT00667810|EG002|Reported Event|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921249|NCT00667810|EG003|Reported Event|Bapineuzumab 2.0 mg/kg|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
10921250|NCT00667849|BG000|Baseline|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
10921251|NCT00667849|BG001|Baseline|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound).~Sham: sham device identical to active device with the exception of administration of ultrasound"
10921252|NCT00667849|BG002|Baseline|Total|Total of all reporting groups
10921253|NCT00667849|FG000|Participant Flow|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
10921254|NCT00667849|FG001|Participant Flow|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: sham device identical to active device with the exception of administration of ultrasound"
10921255|NCT00667849|OG000|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
10921256|NCT00667849|OG001|Outcome|Sham|Single arm, sham (identical to active device with the exception of administration of ultrasound)
10921257|NCT00667849|OG001|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: device identical to active device with the exception of administration of ultrasound"
10921258|NCT00667849|OG000|Outcome|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
10921259|NCT00667849|OG001|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~sham: sham device identical to active device with the exception of administration of ultrasound"
10921260|NCT00667849|EG000|Reported Event|Exogen 4000+|"Single arm, active Exogen 4000+ ultrasound bone healing system~Low-intensity pulsed ultrasound (LIPUS)"
10921261|NCT00667849|EG001|Reported Event|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: device identical to active device with the exception of administration of ultrasound"
10921262|NCT00667862|BG000|Baseline|Panobinostat|Participants with metastatic hormone refractory prostate cancer received 20 mg/m^2 of panobinostat i.v. on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.
10921263|NCT00667862|FG000|Participant Flow|Panobinostat|Participants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.
10921264|NCT00667862|OG000|Outcome|Panobinostat|Participants with metastatic hormone refractory prostate cancer received 20 mg/m^2 of panobinostat i.v. on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.
10921265|NCT00667862|EG000|Reported Event|Panobinostat|Participants with metastatic hormone refractory prostate cancer received 20 mg/m^2 of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.
10921266|NCT00667875|BG000|Baseline|1 Placebo|Placebo : placebo
10921267|NCT00667875|BG001|Baseline|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
10921268|NCT00667875|BG002|Baseline|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
10921269|NCT00667875|BG003|Baseline|Total|Total of all reporting groups
10921270|NCT00667875|FG000|Participant Flow|1 Placebo|Placebo : placebo
10921271|NCT00667875|FG001|Participant Flow|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
10921272|NCT00667875|FG002|Participant Flow|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
10921273|NCT00667875|OG000|Outcome|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
10921274|NCT00667875|OG001|Outcome|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
10921275|NCT00667875|OG002|Outcome|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
11175039|NCT02026297|OG001|Outcome|Treated, Low Risk PPH|"Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.~Tranexamic Acid: 1 gram IV over 10 minutes"
11175040|NCT02026297|EG000|Reported Event|Control, Low Risk PPH|"Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.~Placebo; Normal Saline: 0.9% Normal Saline"
10921276|NCT00667875|OG000|Outcome|Placebo: Placebo|Placebo naltrexone and placebo aripiprazole
11175041|NCT02026297|EG001|Reported Event|Treated, Low Risk PPH|"Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.~Tranexamic Acid: 1 gram IV over 10 minutes"
11175042|NCT02026453|BG000|Baseline|Usual Care|Physicians and nurses obtain admission medication history.
10921277|NCT00667875|OG001|Outcome|Naltrexone: Placebo Aripiprazole|"Naltrexone~Naltrexone: Naltrexone (25mg or 50 mg per titration schedule): placebo aripiprazole"
10921278|NCT00667875|OG002|Outcome|Naltrexone:Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
10921279|NCT00667875|OG000|Outcome|1 Placebo|Placebo : placebo
10921280|NCT00667875|OG001|Outcome|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
10921281|NCT00667875|OG002|Outcome|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
10921282|NCT00667875|EG000|Reported Event|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
10921283|NCT00667875|EG001|Reported Event|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
10921284|NCT00667875|EG002|Reported Event|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
10921285|NCT00667888|BG000|Baseline|Arm 1: (CIMRT) Conventional Radiotherapy|Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
10921286|NCT00667888|BG001|Baseline|Arm 2: (HIMRT) Hypofractionated Radiotherapy|Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
10921287|NCT00667888|BG002|Baseline|Total|Total of all reporting groups
10921288|NCT00667888|FG000|Participant Flow|Arm 1: (CIMRT) Conventional Radiotherapy|Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
10921289|NCT00667888|FG001|Participant Flow|Arm 2: (HIMRT) Hypofractionated Radiotherapy|Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
10921290|NCT00667888|OG000|Outcome|Arm 1: (CIMRT) Conventional Radiotherapy|Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
10921291|NCT00667888|OG001|Outcome|Arm 2: (HIMRT) Hypofractionated Radiotherapy|Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
10921292|NCT00667888|EG000|Reported Event|Arm 1: (CIMRT) Conventional Radiotherapy|Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
10921293|NCT00667888|EG001|Reported Event|Arm 2: (HIMRT) Hypofractionated Radiotherapy|Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
10921294|NCT00667992|BG000|Baseline|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily, First then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
10964049|NCT00875589|OG001|Outcome|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
10964050|NCT00875589|EG000|Reported Event|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
11175043|NCT02026453|BG001|Baseline|Pharmacist Obtains Home Med hx|Pharmacist obtains admission medication history, although usual care practices may also continue.
10921295|NCT00667992|BG001|Baseline|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
10921296|NCT00667992|BG002|Baseline|Total|Total of all reporting groups
10921297|NCT00667992|FG000|Participant Flow|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily First, Wash out, then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
10921298|NCT00667992|FG001|Participant Flow|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, Wash out, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
10921299|NCT00667992|OG000|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
10921300|NCT00667992|OG001|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
10921301|NCT00667992|OG002|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
10921302|NCT00667992|OG003|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
10921303|NCT00667992|OG002|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
10921304|NCT00667992|OG000|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
10921305|NCT00667992|OG002|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
10921306|NCT00667992|OG002|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
10921307|NCT00667992|OG000|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
11234090|NCT02432235|BG005|Baseline|30 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921308|NCT00667992|OG000|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
10921309|NCT00667992|EG000|Reported Event|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
10921310|NCT00667992|EG001|Reported Event|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
10921311|NCT00667992|EG002|Reported Event|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
10921312|NCT00667992|EG003|Reported Event|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
10921313|NCT00668148|BG000|Baseline|Entire Study Population|"IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Participants were stratified into 5 arms according to the disease condition: Ewing's Sarcoma/PNET, rhabdomyosarcoma, leiomyosarcoma, adipocytic sarcoma, and synovial sarcoma.~Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent."
10921314|NCT00668148|FG000|Participant Flow|Entire Study Population|"IMC-A12 (cixutumumab) 10 milligrams per kilogram (mg/kg) dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Participants were stratified into 5 arms according to the disease condition: Ewing's Sarcoma/peripheral neuroectodermal tumor (PNET), rhabdomyosarcoma, leiomyosarcoma, adipocytic sarcoma, and synovial sarcoma.~Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent."
10921315|NCT00668148|OG000|Outcome|Ewing's Sarcoma/PNET|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent.
10921316|NCT00668148|OG001|Outcome|Rhabdomyosarcoma|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent.
10921317|NCT00668148|OG002|Outcome|Leiomyosarcoma|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent.
10921318|NCT00668148|OG003|Outcome|Adipocytic Sarcoma|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent.
10921319|NCT00668148|OG004|Outcome|Synovial Sarcoma|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent.
10921320|NCT00668148|OG005|Outcome|Total|Total of all reporting groups.
10921321|NCT00668148|OG000|Outcome|Ewing's Sarcoma/PNET|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent.
10921322|NCT00668148|OG001|Outcome|Rhabdomyosarcoma|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent.
10921323|NCT00668148|OG002|Outcome|Leiomyosarcoma|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent.
10921324|NCT00668148|OG003|Outcome|Adipocytic Sarcoma|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent.
11234091|NCT02432235|BG006|Baseline|45 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921325|NCT00668148|OG004|Outcome|Synovial Sarcoma|IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent.
10921326|NCT00668148|OG000|Outcome|Entire Study Population|"IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Participants were stratified into 5 arms according to the disease condition: Ewing's Sarcoma/PNET, rhabdomyosarcoma, leiomyosarcoma, adipocytic sarcoma, and synovial sarcoma.~Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent."
10921327|NCT00668148|EG000|Reported Event|Entire Study Population|"IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Participants were stratified into 5 arms according to the disease condition: Ewing's sarcoma/PNET, rhabdomyosarcoma, leiomyosarcoma, adipocytic sarcoma, and synovial sarcoma.~Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent."
10921328|NCT00668200|BG000|Baseline|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
10921329|NCT00668200|FG000|Participant Flow|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
11175044|NCT02026453|BG002|Baseline|Pharm Tech Obtains Home Med hx|Pharmacy technician obtains admission medication history, although usual care practices may also continue.
11175045|NCT02026453|BG003|Baseline|Total|Total of all reporting groups
11175046|NCT02026453|FG000|Participant Flow|Usual Care|Physicians and nurses obtain admission medication history.
11175047|NCT02026453|FG001|Participant Flow|Pharmacist Obtains Home Med hx|"Pharmacist obtains admission medication history, although usual care practices may also continue.~Pharmacist obtains admission medication history"
11175048|NCT02026453|FG002|Participant Flow|Pharm Tech Obtains Home Med hx|"Pharmacy technician obtains admission medication history, although usual care practices may also continue.~Pharmacy technician obtains admission medication history"
11175049|NCT02026453|OG000|Outcome|Usual Care|Physicians and nurses obtain admission medication history.
10921330|NCT00668200|OG000|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
10921331|NCT00668200|EG000|Reported Event|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
10921332|NCT00668317|BG000|Baseline|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
11175050|NCT02026453|OG001|Outcome|Pharmacist Obtains Home Med hx|"Pharmacist obtains admission medication history, although usual care practices may also continue.~Pharmacist obtains admission medication history"
11175051|NCT02026453|OG002|Outcome|Pharm Tech Obtains Home Med hx|"Pharmacy technician obtains admission medication history, although usual care practices may also continue.~Pharmacy technician obtains admission medication history"
11175052|NCT02026453|EG000|Reported Event|Usual Care|Physicians and nurses obtain admission medication history.
11175053|NCT02026453|EG001|Reported Event|Pharmacist Obtains Home Med hx|"Pharmacist obtains admission medication history, although usual care practices may also continue.~Pharmacist obtains admission medication history"
11175054|NCT02026453|EG002|Reported Event|Pharm Tech Obtains Home Med hx|"Pharmacy technician obtains admission medication history, although usual care practices may also continue.~Pharmacy technician obtains admission medication history"
10921333|NCT00668317|FG000|Participant Flow|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
10921334|NCT00668317|OG000|Outcome|Omeprazole and Ranitidine|Therapy with omeprazole 20 mg twice a day (BD) and Ranitidine 300mg once a day (od) at night (nocte)
10921335|NCT00668317|EG000|Reported Event|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
10921336|NCT00668382|BG000|Baseline|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
10921337|NCT00668382|FG000|Participant Flow|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
10921338|NCT00668382|OG000|Outcome|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
10921339|NCT00668382|EG000|Reported Event|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
10921340|NCT00668395|BG000|Baseline|CYP2B6*1/*1|Normal metabolizer
10921341|NCT00668395|BG001|Baseline|CYP2B6*1/*6|Intermediate metabolizer
11175055|NCT02026687|BG000|Baseline|Epidural Analgesia|"The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour.~Epidural"
11175056|NCT02026687|BG001|Baseline|Intrathecal Analgesia|"The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.~Intrathecal"
11175057|NCT02026687|BG002|Baseline|Total|Total of all reporting groups
11234092|NCT02432235|BG007|Baseline|60 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921342|NCT00668395|BG002|Baseline|CYP2B6*6/*6|Slow metabolizer
10921343|NCT00668395|BG003|Baseline|Total|Total of all reporting groups
10921344|NCT00668395|FG000|Participant Flow|CYP2B6*1/*1 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
10921345|NCT00668395|FG001|Participant Flow|CYP2B6*1/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
10921346|NCT00668395|FG002|Participant Flow|CYP2B6*6/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
10921347|NCT00668395|OG000|Outcome|CYP2B6*1/*1|Normal metabolizer
10921348|NCT00668395|OG001|Outcome|CYP2B6*1/*6|Intermediate metabolizer
10921349|NCT00668395|OG002|Outcome|CYP2B6*6/*6|Slow metabolizer
10921350|NCT00668395|EG000|Reported Event|CYP2B6*1/*1|Normal metabolizer
10921351|NCT00668395|EG001|Reported Event|CYP2B6*1/*6|Intermediate metabolizer
10921352|NCT00668395|EG002|Reported Event|CYP2B6*6/*6|Slow metabolizer
10921353|NCT00668434|BG000|Baseline|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
10921354|NCT00668434|BG001|Baseline|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
10921355|NCT00668434|BG002|Baseline|Total|Total of all reporting groups
10921356|NCT00668434|FG000|Participant Flow|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
10921357|NCT00668434|FG001|Participant Flow|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
10921358|NCT00668434|OG000|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
10921359|NCT00668434|OG001|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
10921360|NCT00668434|EG000|Reported Event|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
10921361|NCT00668434|EG001|Reported Event|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
10921362|NCT00668525|BG000|Baseline|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921363|NCT00668525|BG001|Baseline|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921364|NCT00668525|BG002|Baseline|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921365|NCT00668525|BG003|Baseline|Total|Total of all reporting groups
10921366|NCT00668525|FG000|Participant Flow|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921367|NCT00668525|FG001|Participant Flow|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10964051|NCT00875589|EG001|Reported Event|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
10921368|NCT00668525|FG002|Participant Flow|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921369|NCT00668525|OG000|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921370|NCT00668525|OG001|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921371|NCT00668525|OG002|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921372|NCT00668525|EG000|Reported Event|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921373|NCT00668525|EG001|Reported Event|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921374|NCT00668525|EG002|Reported Event|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
10921375|NCT00668564|BG000|Baseline|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
10921376|NCT00668564|FG000|Participant Flow|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
11234093|NCT02432235|BG008|Baseline|80 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921377|NCT00668564|OG000|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
10921378|NCT00668564|EG000|Reported Event|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
10921379|NCT00668707|BG000|Baseline|Treatment|"To receive 20 mg of melatonin nightly for 1 year~melatonin: 20 mgs ingested nightly"
10921380|NCT00668707|BG001|Baseline|Placebo|"To receive matched supplement to the experimental arm in same schedule~placebo: similar to experimental in all ways except for lack of active ingredient"
10921381|NCT00668707|BG002|Baseline|Total|Total of all reporting groups
10921382|NCT00668707|FG000|Participant Flow|Treatment|"To receive 20 mg of melatonin nightly for 1 year~melatonin: 20 mg ingested nightly"
10921383|NCT00668707|FG001|Participant Flow|Placebo|"To receive matched supplement to the experimental arm in same schedule~placebo: similar to experimental in all ways except for lack of active ingredient"
10921384|NCT00668707|OG000|Outcome|Melatonin|To receive 20 mg of melatonin nightly for 1 year following surgery.
10921385|NCT00668707|OG001|Outcome|Placebo|"To receive 20 mg placebo nightly for 1 year following surgery~placebo: similar to experimental in all ways except for lack of active ingredient"
10921386|NCT00668707|OG000|Outcome|Melatonin|To receive 20 mg of melatonin nightly for 1 year post surgery
10921387|NCT00668707|OG001|Outcome|Placebo|"To receive 20 mg placebo nightly for 1 year post surgery~placebo: similar to experimental in all ways except for lack of active ingredient"
10921388|NCT00668707|OG000|Outcome|Melatonin|To receive 20 mg of melatonin nightly for 1 year post-surgery
10921389|NCT00668707|OG001|Outcome|Placebo|"To receive 20 mg placebo nightly for 1 year post-surgery~placebo: similar to experimental in all ways except for lack of active ingredient"
10921390|NCT00668707|OG000|Outcome|Melatonin|To receive 20 mg of melatonin nightly for 1 year following surgery
10921391|NCT00668707|EG000|Reported Event|Melatonin|To receive 20 mg of melatonin nightly for 1 year post-surgery
10921392|NCT00668707|EG001|Reported Event|Placebo|"To receive 20 mg placebo nightly for 1 year post-surgery~placebo: similar to experimental in all ways except for lack of active ingredient"
10921393|NCT00668733|BG000|Baseline|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
10921394|NCT00668733|BG001|Baseline|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
10921395|NCT00668733|BG002|Baseline|Total|Total of all reporting groups
10921396|NCT00668733|FG000|Participant Flow|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
10921397|NCT00668733|FG001|Participant Flow|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
10921398|NCT00668733|OG000|Outcome|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
10921399|NCT00668733|OG001|Outcome|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
10921400|NCT00668733|EG000|Reported Event|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
10921401|NCT00668733|EG001|Reported Event|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
10921402|NCT00668746|BG000|Baseline|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
10921403|NCT00668746|BG001|Baseline|No Drug Intervention|A control consisting of no drug intervention
10921404|NCT00668746|BG002|Baseline|Total|Total of all reporting groups
10921405|NCT00668746|FG000|Participant Flow|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
10921406|NCT00668746|FG001|Participant Flow|No Drug Intervention|A control consisting of no drug intervention
10921407|NCT00668746|OG000|Outcome|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
10921408|NCT00668746|OG001|Outcome|No Drug Intervention|A control consisting of no drug intervention
10921409|NCT00668746|OG000|Outcome|Minocycline Group at Baseline|
10921410|NCT00668746|OG001|Outcome|Minocycline Group at 30 Days|
10921411|NCT00668746|OG002|Outcome|Micocycline Group at 180 Days|
10921412|NCT00668746|OG003|Outcome|Control Group at Baseline|
11175058|NCT02026687|FG000|Participant Flow|Epidural Analgesia|"The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour.~Epidural"
11175059|NCT02026687|FG001|Participant Flow|Intrathecal Analgesia|"The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.~Intrathecal"
11175060|NCT02026687|OG000|Outcome|Epidural|The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the
11234094|NCT02432235|BG009|Baseline|100 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921413|NCT00668746|OG004|Outcome|Control Group at 30 Days|
10921414|NCT00668746|OG005|Outcome|Control Group at 180 Days|
10921415|NCT00668746|OG001|Outcome|Minocycline Group at Day 30|
10921416|NCT00668746|OG002|Outcome|Minocycline Group at Day 180|
10921417|NCT00668746|OG004|Outcome|Control Group at Day 30|
10921418|NCT00668746|OG005|Outcome|Control Group at Day 180|
10921419|NCT00668746|EG000|Reported Event|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
10921420|NCT00668746|EG001|Reported Event|No Drug Intervention|A control consisting of no drug intervention
10921421|NCT00668811|BG000|Baseline|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
10921422|NCT00668811|FG000|Participant Flow|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
10921423|NCT00668811|OG000|Outcome|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
10921424|NCT00668811|EG000|Reported Event|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
10921425|NCT00668863|BG000|Baseline|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
10921426|NCT00668863|FG000|Participant Flow|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
10921427|NCT00668863|OG000|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
10921428|NCT00668863|EG000|Reported Event|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
10921429|NCT00668902|BG000|Baseline|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
11175061|NCT02026687|OG001|Outcome|Spinal|The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
11234095|NCT02432235|BG010|Baseline|150 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921430|NCT00668902|BG001|Baseline|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921431|NCT00668902|BG002|Baseline|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921432|NCT00668902|BG003|Baseline|Total|Total of all reporting groups
10921433|NCT00668902|FG000|Participant Flow|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921434|NCT00668902|FG001|Participant Flow|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921435|NCT00668902|FG002|Participant Flow|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921436|NCT00668902|OG000|Outcome|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921437|NCT00668902|OG001|Outcome|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921438|NCT00668902|OG002|Outcome|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921439|NCT00668902|EG000|Reported Event|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921440|NCT00668902|EG001|Reported Event|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921441|NCT00668902|EG002|Reported Event|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
10921442|NCT00669019|BG000|Baseline|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
10921443|NCT00669019|FG000|Participant Flow|Saracatinib|Patients receive saracatinib 175 mg oral, once daily in the absence of disease progression or unacceptable toxicity.
10921444|NCT00669019|OG000|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
10921445|NCT00669019|EG000|Reported Event|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
10921446|NCT00669032|BG000|Baseline|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
10921447|NCT00669032|BG001|Baseline|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
10921448|NCT00669032|BG002|Baseline|Total|Total of all reporting groups
10921449|NCT00669032|FG000|Participant Flow|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
10921450|NCT00669032|FG001|Participant Flow|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
10921451|NCT00669032|OG000|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
10921452|NCT00669032|OG001|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
10921453|NCT00669032|EG000|Reported Event|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
10921454|NCT00669032|EG001|Reported Event|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
10921455|NCT00669071|BG000|Baseline|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
10921456|NCT00669071|FG000|Participant Flow|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
10921457|NCT00669071|OG000|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
11191904|NCT02135094|EG000|Reported Event|Active Ultrasound Therapy Device|"Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity~Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day"
10921458|NCT00669071|OG001|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
10921459|NCT00669071|OG000|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
10921460|NCT00669071|EG000|Reported Event|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
10921461|NCT00669110|BG000|Baseline|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
10921462|NCT00669110|BG001|Baseline|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
10921463|NCT00669110|BG002|Baseline|Total|Total of all reporting groups
10921464|NCT00669110|FG000|Participant Flow|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
11175062|NCT02026687|EG000|Reported Event|Epidural|The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the
11175063|NCT02026687|EG001|Reported Event|Spinal|The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
11175064|NCT02027025|BG000|Baseline|SPARC1103 Low Dose|Age: 50.5 (9.12)
11175065|NCT02027025|BG001|Baseline|SPARC1103 High Dose|Age: 52.3 (9.33)
11175066|NCT02027025|BG002|Baseline|SPARC Placebo|Age: 50.2 (10.43)
11175067|NCT02027025|BG003|Baseline|Total|Total of all reporting groups
11175068|NCT02027025|FG000|Participant Flow|SPARC1103 Low Dose|"SPARC1103 low dose dosing regimen:~1 capsule orally, approximately 30 minutes"
11175069|NCT02027025|FG001|Participant Flow|SPARC1103 High Dose|"SPARC1103 high dose dosing regimen~1 capsule orally, approximately 30 minutes"
11175070|NCT02027025|FG002|Participant Flow|SPARC Placebo|"SPARC Placebo dosing regimen~1 capsule orally, approximately 30 minutes"
11175071|NCT02027025|OG000|Outcome|SPARC1103 Low Dose|Least square mean difference (Placebo versus SPARC 1103 low dose) in change from baseline in total modified Ashworth score on day 24
11175072|NCT02027025|OG001|Outcome|SPARC1103 High Dose|Least square mean difference (Placebo versus SPARC 1103 high dose) in change from baseline in total modified Ashworth score on day 24
11175073|NCT02027025|OG000|Outcome|SPARC1103 Low Dose|Least square mean difference (Placebo versus SPARC 1103 low dose) in change from baseline in nighttime awakening score on day 24
11175074|NCT02027025|OG001|Outcome|SPARC1103 High Dose|Least square mean difference (Placebo versus SPARC 1103 high dose) in change from baseline in nighttime awakening score on day 24
11175075|NCT02027025|OG002|Outcome|SPARC Placebo|Change from baseline for nighttime awakening score on day 24
11175076|NCT02027025|OG000|Outcome|SPARC1103 Low Dose|Least square mean difference (Placebo versus SPARC 1103 low dose) in change from baseline in spasm frequency on day 24
10921465|NCT00669110|FG001|Participant Flow|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
10921466|NCT00669110|OG000|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
10921467|NCT00669110|OG001|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
11175077|NCT02027025|OG001|Outcome|SPARC1103 High Dose|Least square mean difference (Placebo versus SPARC 1103 high dose) in change from baseline in spasm frequency on day 24
11175078|NCT02027025|OG002|Outcome|SPARC Placebo|Least square mean change from baseline in spasm frequency on day 24
10921468|NCT00669110|EG000|Reported Event|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
11175079|NCT02027025|OG000|Outcome|SPARC1103 Low Dose|Clinical global impression of change results at 24 hours post dose on Day 24
11175080|NCT02027025|OG001|Outcome|SPARC1103 High Dose|Clinical global impression of change results at 24 hours post dose on Day 24
11175081|NCT02027025|OG002|Outcome|SPARC Placebo|Clinical global impression of change results at 24 hours post dose on Day 24
11175082|NCT02027025|OG000|Outcome|SPARC1103 Low Dose|Subject's global impression of severity of spasticity at Day 24
11175083|NCT02027025|OG001|Outcome|SPARC1103 High Dose|Subject's global impression of severity of spasticity at Day 24
11175084|NCT02027025|OG002|Outcome|SPARC Placebo|Subject's global impression of severity of spasticity at Day 24
11175085|NCT02027025|EG000|Reported Event|SPARC1103 Low Dose|Subjects with treatment emergent adverse events
11175086|NCT02027025|EG001|Reported Event|SPARC1103 High Dose|Subjects with treatment emergent adverse events
11175087|NCT02027025|EG002|Reported Event|SPARC Placebo|Subjects with treatment emergent adverse events
10921469|NCT00669110|EG001|Reported Event|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
10921470|NCT00669162|BG000|Baseline|RT, Docetaxel, Hormonal Therapy|"Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)~Docetaxel: 20mg/m2 IV weekly for 7 weeks~Radiation Therapy: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx~Casodex and Zoladex (or Lupron): Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)"
10921471|NCT00669162|FG000|Participant Flow|RT, Docetaxel, Hormonal Therapy|"Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)~Docetaxel: 20mg/m2 IV weekly for 7 weeks~Radiation Therapy: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx~Casodex and Zoladex (or Lupron): Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)"
10921472|NCT00669162|OG000|Outcome|RT, Docetaxel, Hormonal Therapy|"Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)~Docetaxel: 20mg/m2 IV weekly for 7 weeks~Radiation Therapy: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx~Casodex and Zoladex (or Lupron): Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)"
10921473|NCT00669162|EG000|Reported Event|RT, Docetaxel, Hormonal Therapy|"Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)~Docetaxel: 20mg/m2 IV weekly for 7 weeks~Radiation Therapy: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx~Casodex and Zoladex (or Lupron): Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)"
10921474|NCT00669214|BG000|Baseline|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
10921475|NCT00669214|BG001|Baseline|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
10921476|NCT00669214|BG002|Baseline|Total|Total of all reporting groups
10921477|NCT00669214|FG000|Participant Flow|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
10921478|NCT00669214|FG001|Participant Flow|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
10921479|NCT00669214|OG000|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
10921480|NCT00669214|OG001|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
10921481|NCT00669214|EG000|Reported Event|Placebo: Double-Blind Period|All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
10921482|NCT00669214|EG001|Reported Event|Efalizumab: Double-Blind Period|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
10921483|NCT00669214|EG002|Reported Event|Placebo: Open-Label Period|
10921484|NCT00669214|EG003|Reported Event|Efalizumab: Open-Label Period|
10921485|NCT00669214|EG004|Reported Event|Placebo: Follow-Up Period|
11175088|NCT02027311|BG000|Baseline|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11234096|NCT02432235|BG011|Baseline|300 μg/kg|"A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).~Camidanlumab tesirine: Intravenous (IV) infusion."
11234097|NCT02432235|BG012|Baseline|Total|Total of all reporting groups
10921486|NCT00669214|EG005|Reported Event|Efalizumab: Follow-Up Period|
10964052|NCT00875615|BG000|Baseline|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
11175089|NCT02027311|BG001|Baseline|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11175090|NCT02027311|BG002|Baseline|Total|Total of all reporting groups
11175091|NCT02027311|FG000|Participant Flow|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11234098|NCT02432235|FG000|Participant Flow|3 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11175092|NCT02027311|FG001|Participant Flow|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11175093|NCT02027311|OG000|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11175094|NCT02027311|OG001|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11175095|NCT02027311|OG000|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11234099|NCT02432235|FG001|Participant Flow|5 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11175096|NCT02027311|OG001|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11175097|NCT02027311|EG000|Reported Event|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11191905|NCT02135094|EG001|Reported Event|Placebo Ultrasound Therapy Device|"Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound."
11357602|NCT03754556|EG000|Reported Event|Women With IUD|Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.
11357603|NCT03753113|BG000|Baseline|Treatment Group|"The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.~Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.~Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks."
11357604|NCT03753113|BG001|Baseline|Control Group|"The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks~Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks."
11357605|NCT03753113|BG002|Baseline|Total|Total of all reporting groups
11357606|NCT03753113|FG000|Participant Flow|Treatment Group|"The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.~Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.~Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks."
11357607|NCT03753113|FG001|Participant Flow|Control Group|"The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.~Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks."
11357608|NCT03753113|OG000|Outcome|Treatment Group|"The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks~Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months~Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months"
11357609|NCT03753113|OG001|Outcome|Control Group|"The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks~Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months"
11357610|NCT03753113|EG000|Reported Event|Treatment Group|"The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks~Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months~Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months"
11357611|NCT03753113|EG001|Reported Event|Control Group|"The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks~Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months"
11357612|NCT03752567|BG000|Baseline|Group Study|Enrolled patients include people with reduced glucose tolerance, or impaired fasting blood sugar, or type 2 diabetes free of organ complications, or type 2 diabetes with chronic complications.
11357613|NCT03752567|FG000|Participant Flow|Group Study|"Follow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, fundus oculi, ankle arm index) and self analysis (glycated hemoglobin, lipid profile, uric acid microalbuminuria).~Follow up: like group descriptions"
11357614|NCT03752567|OG000|Outcome|Group Study|"The patients enrolled were 40.~Based on the staging of diabetic disease, the enrolled population was made up as follows:~reduced glucose tolerance~impaired fasting blood sugar~type 2 diabetes free of organ complications~type 2 diabetes with chronic complications"
11357615|NCT03752567|EG000|Reported Event|Group Study|"The 40 patients enrolled were 50% men and 50% women. The average age was 64.5 years. The median of the comorbidities presented by the participants was two, and in 33% (n = 13) of the cases there were more than 2 comorbidities per patient.~Based on the staging of diabetic disease, the enrolled population was made up as follows:~reduced glucose tolerance 15%~impaired fasting blood sugar 5%~type 2 diabetes free of organ complications 38%~type 2 diabetes with chronic complications 42%"
11357616|NCT03752528|BG000|Baseline|All Study Participants|All study participants who enrolled into the Part A Cohort. These participants previously participated in study RB-US-13-0003 or both studies RB-US-13-0003 and INDV-6000-301 and who received at least 2 doses of SUBLOCADE 12-36 months prior. Some of the participants continued into study Part B after completing Part A.
11357617|NCT03752528|FG000|Participant Flow|All Study Participants|All study participants who enrolled into the Part A Cohort. These participants previously participated in study RB-US-13-0003 or both studies RB-US-13-0003 and INDV-6000-301 and who received at least 2 doses of SUBLOCADE 12-36 months prior. Some of the participants continued into study Part B after completing Part A.
11357618|NCT03752528|OG000|Outcome|Part A Cohort: Visit 1|Representative data set of participants from study RB-US-13-0003 or both studies RB-US-13-0003 and INDV-6000-301 who received at least 2 doses of SUBLOCADE 12-36 months prior. Part A consists of a single visit (Visit 1) for both screening and collection of blood and urine samples.
11357619|NCT03752528|OG001|Outcome|Part B Cohort: Visit 1|Part A participants with a quantifiable (i.e. positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e. negative) result for naloxone continue in the study for two additional visits (Part B, Visits 2 and 3). This cohort reports Visit 1 results for those participants who continued into Part B of the study.
11357620|NCT03752528|OG002|Outcome|Part B Cohort: Visit 2|Part A participants with a quantifiable (i.e. positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e. negative) result for naloxone continue in the study for two additional visits (Part B, Visits 2 and 3). This cohort reports Visit 2 (Day 30) results for those participants who continued into Part B of the study.
10921487|NCT00669240|BG000|Baseline|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
10921488|NCT00669240|FG000|Participant Flow|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
10921489|NCT00669240|OG000|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
10964053|NCT00875615|FG000|Participant Flow|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
11175098|NCT02027311|EG001|Reported Event|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
11191906|NCT02135107|BG000|Baseline|Rabeprazole: 10 mg Twice Daily|Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
10921490|NCT00669240|EG000|Reported Event|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
10921491|NCT00669279|BG000|Baseline|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
10921492|NCT00669279|BG001|Baseline|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
10921493|NCT00669279|BG002|Baseline|Total|Total of all reporting groups
10921494|NCT00669279|FG000|Participant Flow|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
10921495|NCT00669279|FG001|Participant Flow|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
10921496|NCT00669279|OG000|Outcome|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
10921497|NCT00669279|OG001|Outcome|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
10921498|NCT00669279|EG000|Reported Event|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
10921499|NCT00669279|EG001|Reported Event|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
10921500|NCT00669318|BG000|Baseline|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
10921501|NCT00669318|FG000|Participant Flow|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
10921502|NCT00669318|OG000|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
11191907|NCT02135107|BG001|Baseline|Rabeprazole: 20 mg Twice Daily|Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
10921503|NCT00669318|EG000|Reported Event|Treatment (Pentostatin, Alemtuzumab, Rituximab)|sargramostim
10921504|NCT00669331|BG000|Baseline|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
10921505|NCT00669331|BG001|Baseline|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
10921506|NCT00669331|BG002|Baseline|Total|Total of all reporting groups
10921507|NCT00669331|FG000|Participant Flow|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
10921508|NCT00669331|FG001|Participant Flow|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
10921509|NCT00669331|OG000|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
10921510|NCT00669331|OG001|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
10921511|NCT00669331|OG000|Outcome|Mannitol|"Inhaled mannitol 400mg~Inhaled mannitol: 400mg dose of Mannitol BD for 52 weeks"
10921512|NCT00669331|OG001|Outcome|Control|"Matched control - inhaled mannitol 50mg~Matched control: 50mg dose of Mannitol BD for 52 weeks"
10921513|NCT00669331|EG000|Reported Event|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
10921514|NCT00669331|EG001|Reported Event|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
10921515|NCT00669383|BG000|Baseline|A (Betamethasone)|"Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses~betamethasone: 12 mg IM q 24 hours x 2 doses"
10921516|NCT00669383|BG001|Baseline|B (Placebo)|"Placebo dose IM q 24 hours x 2 doses~placebo: Placebo IM q 24 hours x 2 doses"
10921517|NCT00669383|BG002|Baseline|Total|Total of all reporting groups
11191908|NCT02135107|BG002|Baseline|Total|Total of all reporting groups
11191909|NCT02135107|FG000|Participant Flow|Rabeprazole: 10 mg Twice Daily|Rabeprazole (10 mg) was administered orally twice daily during the treatment period for 8 weeks (unblinded).
10921518|NCT00669383|FG000|Participant Flow|A (Betamethasone)|Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
10921519|NCT00669383|FG001|Participant Flow|B (Placebo)|Placebo dose IM q 24 hours x 2 doses
10921520|NCT00669383|OG000|Outcome|A (Betamethasone)|Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
10921521|NCT00669383|OG001|Outcome|B (Placebo)|Placebo dose IM q 24 hours x 2 doses
10921522|NCT00669383|EG000|Reported Event|A (Betamethasone)|Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
10921523|NCT00669383|EG001|Reported Event|B (Placebo)|Placebo dose IM q 24 hours x 2 doses
10921524|NCT00669396|BG000|Baseline|Copper T380 IUD|IUD
10921525|NCT00669396|BG001|Baseline|Levonorgestrel|Oral levonorgestrel
10921526|NCT00669396|BG002|Baseline|Total|Total of all reporting groups
10921527|NCT00669396|FG000|Participant Flow|Copper T380 IUD|IUD
10921528|NCT00669396|FG001|Participant Flow|Levonorgestrel|Oral levonorgestrel
10921529|NCT00669396|OG000|Outcome|Copper T380 IUD|IUD
10921530|NCT00669396|OG001|Outcome|Levonorgestrel|Oral levonorgestrel
10921531|NCT00669396|EG000|Reported Event|Copper T380 IUD|IUD
10921532|NCT00669396|EG001|Reported Event|Levonorgestrel|Oral levonorgestrel
10921533|NCT00669409|BG000|Baseline|Tanezumab 10 mcg/kg|Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921534|NCT00669409|BG001|Baseline|Tanezumab 25 mcg/kg|Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921535|NCT00669409|BG002|Baseline|Tanezumab 50 mcg/kg|Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921536|NCT00669409|BG003|Baseline|Tanezumab 100 mcg/kg|Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921537|NCT00669409|BG004|Baseline|Tanezumab 200 mcg/kg|Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.
10921538|NCT00669409|BG005|Baseline|Placebo|Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
10921539|NCT00669409|BG006|Baseline|Total|Total of all reporting groups
10921540|NCT00669409|FG000|Participant Flow|Tanezumab 10 mcg/kg - Part 1|Single intravenous infusion of tanezumab 10 microgram/kilogram (mcg/kg) over 10 minutes on Day 1 during Part 1.
10921541|NCT00669409|FG001|Participant Flow|Tanezumab 25 mcg/kg - Part 1|Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1.
10921542|NCT00669409|FG002|Participant Flow|Tanezumab 50 mcg/kg - Part 1|Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1.
10921543|NCT00669409|FG003|Participant Flow|Tanezumab 100 mcg/kg - Part 1|Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1.
10921544|NCT00669409|FG004|Participant Flow|Tanezumab 200 mcg/kg - Part 1|Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.
10921545|NCT00669409|FG005|Participant Flow|Placebo - Part 1|Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1.
10921546|NCT00669409|FG006|Participant Flow|Tanezumab 10 mcg/kg - Part 2|Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 2.
10921547|NCT00669409|FG007|Participant Flow|Tanezumab 25 mcg/kg - Part 2|Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 2.
10921548|NCT00669409|FG008|Participant Flow|Tanezumab 50 mcg/kg - Part 2|Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 2.
10921549|NCT00669409|FG009|Participant Flow|Tanezumab 100 mcg/kg - Part 2|Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 2.
10921550|NCT00669409|FG010|Participant Flow|Placebo - Part 2|Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 2.
10921551|NCT00669409|OG000|Outcome|Tanezumab 10 mcg/kg|Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921552|NCT00669409|OG001|Outcome|Tanezumab 25 mcg/kg|Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921553|NCT00669409|OG002|Outcome|Tanezumab 50 mcg/kg|Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921554|NCT00669409|OG003|Outcome|Tanezumab 100 mcg/kg|Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921555|NCT00669409|OG004|Outcome|Tanezumab 200 mcg/kg|Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.
10921556|NCT00669409|OG005|Outcome|Placebo|Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
10921557|NCT00669409|OG000|Outcome|Tanezumab 10 mcg/kg|Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and 2.
10921558|NCT00669409|OG001|Outcome|Tanezumab 25 mcg/kg|Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and 2.
10921559|NCT00669409|OG002|Outcome|Tanezumab 50 mcg/kg|Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and 2.
10921560|NCT00669409|OG003|Outcome|Tanezumab 100 mcg/kg|Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and 2.
10921561|NCT00669409|OG005|Outcome|Placebo|Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and 2.
10921562|NCT00669409|OG000|Outcome|Tanezumab 10 mcg/kg|Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1.
10921563|NCT00669409|OG001|Outcome|Tanezumab 25 mcg/kg|Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1.
10921564|NCT00669409|OG002|Outcome|Tanezumab 50 mcg/kg|Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1.
10921565|NCT00669409|OG003|Outcome|Tanezumab 100 mcg/kg|Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1.
10921566|NCT00669409|OG005|Outcome|Placebo|Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1.
10921567|NCT00669409|OG000|Outcome|Tanezumab 100 mcg/kg|Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921568|NCT00669409|OG001|Outcome|Tanezumab 200 mcg/kg|Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.
10921569|NCT00669409|OG002|Outcome|Placebo|Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
10921570|NCT00669409|EG000|Reported Event|Tanezumab 10 mcg/kg|Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921571|NCT00669409|EG001|Reported Event|Tanezumab 25 mcg/kg|Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921572|NCT00669409|EG002|Reported Event|Tanezumab 50 mcg/kg|Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921573|NCT00669409|EG003|Reported Event|Tanezumab 100 mcg/kg|Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.
10921574|NCT00669409|EG004|Reported Event|Tanezumab 200 mcg/kg|Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.
10921575|NCT00669409|EG005|Reported Event|Placebo|Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
10921576|NCT00669539|BG000|Baseline|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
10921577|NCT00669539|BG001|Baseline|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
10921578|NCT00669539|BG002|Baseline|Total|Total of all reporting groups
10921579|NCT00669539|FG000|Participant Flow|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
10921580|NCT00669539|FG001|Participant Flow|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
10921581|NCT00669539|OG000|Outcome|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
10921582|NCT00669539|OG001|Outcome|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
10921583|NCT00669539|EG000|Reported Event|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
10921584|NCT00669539|EG001|Reported Event|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
10921585|NCT00669552|BG000|Baseline|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
10921586|NCT00669552|FG000|Participant Flow|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
10921587|NCT00669552|OG000|Outcome|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
10921588|NCT00669552|EG000|Reported Event|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
10921589|NCT00669578|BG000|Baseline|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
10921590|NCT00669578|BG001|Baseline|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
10921591|NCT00669578|BG002|Baseline|Total|Total of all reporting groups
10921592|NCT00669578|FG000|Participant Flow|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
10921593|NCT00669578|FG001|Participant Flow|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
10921594|NCT00669578|OG000|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
10921595|NCT00669578|OG001|Outcome|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
10921596|NCT00669578|OG000|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
10921597|NCT00669578|OG001|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
10921598|NCT00669578|EG000|Reported Event|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
10921599|NCT00669617|BG000|Baseline|Total Population|Participants were randomized to one of five treatment sequences. Each treatment sequence comprised 5 double-blind, single dose treatment periods (Periods I to V), separated by a washout period of 4-7 days. Participants received each of the 5 blinded-treatments: indacaterol 150 μg, indacaterol 300 μg, salmeterol/fluticasone 50/500 μg, salbutamol 200 μg and placebo.
10921600|NCT00669617|FG000|Participant Flow|Ind 150μg, Salm/Flut, Ind 300μg, Placebo, Salbut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921601|NCT00669617|FG001|Participant Flow|Ind 300μg, Ind 150μg, Salbut, Salm/Flut, Placebo|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921602|NCT00669617|FG002|Participant Flow|Salm/Flut, Placebo, Ind 150μg, Salbut, Ind 300μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921603|NCT00669617|FG003|Participant Flow|Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/Flut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921604|NCT00669617|FG004|Participant Flow|Placebo, Salbut, Salm/Flut , Ind 300μg, Ind 150μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/Flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921605|NCT00669617|OG000|Outcome|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921606|NCT00669617|OG001|Outcome|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and a placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921607|NCT00669617|OG002|Outcome|Placebo|Participants received placebo to indacaterol delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous one by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11191910|NCT02135107|FG001|Participant Flow|Rabeprazole: 20 mg Twice Daily|Rabeprazole (20 mg) was administered orally twice daily during the treatment period for 8 weeks (unblinded).
10921608|NCT00669617|OG003|Outcome|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921609|NCT00669617|OG004|Outcome|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921610|NCT00669617|EG000|Reported Event|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921611|NCT00669617|EG001|Reported Event|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921612|NCT00669617|EG002|Reported Event|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921613|NCT00669617|EG003|Reported Event|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921614|NCT00669617|EG004|Reported Event|Placebo|Participants received placebo to indacaterol delivered via SDDPI, a placebo to salmeterol/fluticasone delivered via MDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10921615|NCT00669682|BG000|Baseline|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
10921616|NCT00669682|FG000|Participant Flow|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
10921617|NCT00669682|OG000|Outcome|Positive Optivol Status|These patients have transthoracic impedance measurements that suggest fluid overload
10921618|NCT00669682|OG001|Outcome|Negative Optivol Status|These patients have transthoracic impedance measurements that do not suggest fluid overload
10921619|NCT00669682|EG000|Reported Event|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
10921620|NCT00669864|BG000|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
10921621|NCT00669864|FG000|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
10921622|NCT00669864|OG000|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
10921623|NCT00669864|EG000|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
10921624|NCT00669877|BG000|Baseline|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
11175099|NCT02027376|BG000|Baseline|LDE225 (Sonidegib) in Combination With Docetaxel|"Eligible patients will be included and treated with docetaxel intravenously (75mg/m2) in every three weeks cycles and LDE225 will be administered orally at three dose levels 400, 600 and 800mg QD. Treatment will be repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.~Dose Level 1: 5 patients were included (2 of them were replaced due to progression before completing cycle 2)~Dose Level 2: 4 patients were included (1 of them were replaced due to progression before completing cycle 2)~Dose Level 3: 3 patients were included"
11175100|NCT02027376|FG000|Participant Flow|LDE225 (Sonidegib) 400mg in Combination With Docetaxel|Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
10921625|NCT00669877|FG000|Participant Flow|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
10921626|NCT00669877|OG000|Outcome|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
10921627|NCT00669877|EG000|Reported Event|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
10921628|NCT00669903|BG000|Baseline|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
10921629|NCT00669903|BG001|Baseline|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
10921630|NCT00669903|BG002|Baseline|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
10921631|NCT00669903|BG003|Baseline|Placebo|Placebo
10921632|NCT00669903|BG004|Baseline|Total|Total of all reporting groups
10921633|NCT00669903|FG000|Participant Flow|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
11175101|NCT02027376|FG001|Participant Flow|LDE225 (Sonidegib) 600mg in Combination With Docetaxel|Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
11175102|NCT02027376|FG002|Participant Flow|LDE225 (Sonidegib) 800mg in Combination With Docetaxel|Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
10921634|NCT00669903|FG001|Participant Flow|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
10921635|NCT00669903|FG002|Participant Flow|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
10921636|NCT00669903|FG003|Participant Flow|Placebo|Placebo
10921637|NCT00669903|OG000|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
10921638|NCT00669903|OG001|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
10921639|NCT00669903|OG002|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
10921640|NCT00669903|OG003|Outcome|Placebo|Placebo
10921641|NCT00669903|EG000|Reported Event|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
10921642|NCT00669903|EG001|Reported Event|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
10921643|NCT00669903|EG002|Reported Event|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
10921644|NCT00669903|EG003|Reported Event|Placebo|Placebo
10921645|NCT00669916|BG000|Baseline|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
10921646|NCT00669916|BG001|Baseline|Placebo|Placebo was administered intravenously as a single dose.
10921647|NCT00669916|BG002|Baseline|Total|Total of all reporting groups
10921648|NCT00669916|FG000|Participant Flow|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
10921649|NCT00669916|FG001|Participant Flow|Placebo|Placebo was administered intravenously as a single dose.
10921650|NCT00669916|OG000|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
10921651|NCT00669916|OG001|Outcome|Placebo|Placebo was administered intravenously as a single dose.
10921652|NCT00669916|EG000|Reported Event|AIN457A|AIN457A 3mg/kg was administered intravenously as a single dose.
10921653|NCT00669916|EG001|Reported Event|Placebo|Placebo was administered intravenously as a single dose.
10921654|NCT00669942|BG000|Baseline|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
10921655|NCT00669942|BG001|Baseline|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
10921656|NCT00669942|BG002|Baseline|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
11234100|NCT02432235|FG002|Participant Flow|8 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10921657|NCT00669942|BG003|Baseline|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
10921658|NCT00669942|BG004|Baseline|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
10921659|NCT00669942|BG005|Baseline|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921660|NCT00669942|BG006|Baseline|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921661|NCT00669942|BG007|Baseline|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921662|NCT00669942|BG008|Baseline|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921663|NCT00669942|BG009|Baseline|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
10921664|NCT00669942|BG010|Baseline|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
10921665|NCT00669942|BG011|Baseline|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
10921666|NCT00669942|BG012|Baseline|Total|Total of all reporting groups
10921667|NCT00669942|FG000|Participant Flow|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
10921668|NCT00669942|FG001|Participant Flow|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
10921669|NCT00669942|FG002|Participant Flow|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
10921670|NCT00669942|FG003|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
10921671|NCT00669942|FG004|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
10921672|NCT00669942|FG005|Participant Flow|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921673|NCT00669942|FG006|Participant Flow|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921674|NCT00669942|FG007|Participant Flow|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921675|NCT00669942|FG008|Participant Flow|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921676|NCT00669942|FG009|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
10921677|NCT00669942|FG010|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
10921678|NCT00669942|FG011|Participant Flow|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
10921679|NCT00669942|OG000|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921680|NCT00669942|OG001|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921681|NCT00669942|OG000|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
10921682|NCT00669942|OG001|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
10921683|NCT00669942|OG002|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
10921684|NCT00669942|OG003|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
10921685|NCT00669942|OG000|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921686|NCT00669942|OG001|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921687|NCT00669942|OG002|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921688|NCT00669942|EG000|Reported Event|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
10921689|NCT00669942|EG001|Reported Event|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
10921690|NCT00669942|EG002|Reported Event|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
10921691|NCT00669942|EG003|Reported Event|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
10921692|NCT00669942|EG004|Reported Event|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
10921693|NCT00669942|EG005|Reported Event|Parts 2 and 3 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921694|NCT00669942|EG006|Reported Event|Parts 2 and 3 - AIN457 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921695|NCT00669942|EG007|Reported Event|Parts 2 and 3 - AIN457 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921696|NCT00669942|EG008|Reported Event|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10921697|NCT00669942|EG009|Reported Event|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
10921698|NCT00669942|EG010|Reported Event|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
10921699|NCT00669942|EG011|Reported Event|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
10921700|NCT00669955|BG000|Baseline|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
10921701|NCT00669955|BG001|Baseline|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
10921702|NCT00669955|BG002|Baseline|Total|Total of all reporting groups
10921703|NCT00669955|FG000|Participant Flow|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
10921704|NCT00669955|FG001|Participant Flow|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
10921705|NCT00669955|OG000|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
10921706|NCT00669955|OG001|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
10921707|NCT00669955|EG000|Reported Event|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
10921708|NCT00669955|EG001|Reported Event|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
10921709|NCT00670007|BG000|Baseline|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight intravenously once per week
10921710|NCT00670007|FG000|Participant Flow|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight administered intravenously once per week
10921711|NCT00670007|OG000|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
10921712|NCT00670007|OG001|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
10921713|NCT00670007|EG000|Reported Event|Zemaira®|The safety population comprised all subjects enrolled in study CE1226_3001 and who received at least 1 administration of Zemaira® during study CE1226_3001.
10921714|NCT00670046|BG000|Baseline|Arm I (Standard of Care)|"Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.~standard of care follow-up: participant follow the standard of care for patient with metastatic prostate cancer"
10921715|NCT00670046|BG001|Baseline|Arm II (Valproic Acid)|"Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.~valproic acid: given orally"
10921716|NCT00670046|BG002|Baseline|Total|Total of all reporting groups
10921717|NCT00670046|FG000|Participant Flow|Arm I (Standard of Care)|"Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.~standard of care follow-up: participant follow the standard of care for patient with metastatic prostate cancer"
10921718|NCT00670046|FG001|Participant Flow|Arm II (Valproic Acid)|"Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.~valproic acid: given orally"
10921719|NCT00670046|OG000|Outcome|Arm I (Standard of Care)|"Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.~standard of care follow-up: participant follow the standard of care for patient with metastatic prostate cancer"
10921720|NCT00670046|OG001|Outcome|Arm II (Valproic Acid)|"Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.~valproic acid: given orally"
10921721|NCT00670046|EG000|Reported Event|Arm I (Standard of Care)|"Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.~standard of care follow-up: participant follow the standard of care for patient with metastatic prostate cancer"
10921722|NCT00670046|EG001|Reported Event|Arm II (Valproic Acid)|"Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.~valproic acid: given orally"
10921723|NCT00670111|BG000|Baseline|Rate Adaptive Pacing (RAP) On Then Off|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
11175103|NCT02027376|OG000|Outcome|LDE225 (Sonidegib) 400mg in Combination With Docetaxel|Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
10921724|NCT00670111|BG001|Baseline|Rate Adaptive Pacing (RAP) Off Then On|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
10921725|NCT00670111|BG002|Baseline|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group.
10921726|NCT00670111|BG003|Baseline|Total|Total of all reporting groups
10921727|NCT00670111|FG000|Participant Flow|Rate Adaptive Pacing (RAP) On Then Off|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
10921728|NCT00670111|FG001|Participant Flow|Rate Adaptive Pacing (RAP) Off Then On|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
10921729|NCT00670111|FG002|Participant Flow|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group.
10921730|NCT00670111|OG000|Outcome|Rate Adaptive Pacing (RAP) On at One Month|Rate Adaptive Pacing (RAP) On for cardiopulmonary exercise test (CPX) at one month.
10921731|NCT00670111|OG001|Outcome|Rate Adaptive Pacing (RAP) Off at One Month|Rate Adaptive Pacing (RAP) Off for cardiopulmonary exercise test (CPX) at one month.
10921732|NCT00670111|OG000|Outcome|Rate Adaptive Pacing (RAP) On at Six Months|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
10921733|NCT00670111|OG001|Outcome|Rate Adaptive Pacing (RAP) Off at One Month|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
10921734|NCT00670111|EG000|Reported Event|All Implanted Patients|All patients from the RAP On then Off group and from the RAP Off then On group.
10921735|NCT00670111|EG001|Reported Event|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group. Adverse events were collected for all subjects, also for non-randomized patients.
10921736|NCT00670202|BG000|Baseline|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
10921737|NCT00670202|BG001|Baseline|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
10921738|NCT00670202|BG002|Baseline|Total|Total of all reporting groups
10921739|NCT00670202|FG000|Participant Flow|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
10921740|NCT00670202|FG001|Participant Flow|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
10921741|NCT00670202|OG000|Outcome|Drug: Fasudil Hydrochloride|"Fasudil hydrochloride 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
10921742|NCT00670202|OG001|Outcome|Drug: Placebo Oral Tablet|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days"
11175104|NCT02027376|OG001|Outcome|LDE225 (Sonidegib) 600mg in Combination With Docetaxel|Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
10921743|NCT00670202|EG000|Reported Event|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
10921744|NCT00670202|EG001|Reported Event|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
11175105|NCT02027376|OG002|Outcome|LDE225 (Sonidegib) 800mg in Combination With Docetaxel|Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
10921745|NCT00670228|BG000|Baseline|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
10921746|NCT00670228|BG001|Baseline|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
10921747|NCT00670228|BG002|Baseline|Total|Total of all reporting groups
10921748|NCT00670228|FG000|Participant Flow|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
10921749|NCT00670228|FG001|Participant Flow|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
10921750|NCT00670228|OG000|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
10921751|NCT00670228|OG001|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
10921752|NCT00670228|EG000|Reported Event|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
10921753|NCT00670228|EG001|Reported Event|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
10921754|NCT00670241|BG000|Baseline|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
10921755|NCT00670241|BG001|Baseline|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
10921756|NCT00670241|BG002|Baseline|Gel Vehicle|Gel Vehicle for up to 8 weeks
10921757|NCT00670241|BG003|Baseline|Total|Total of all reporting groups
10921758|NCT00670241|FG000|Participant Flow|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
10921759|NCT00670241|FG001|Participant Flow|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
10921760|NCT00670241|FG002|Participant Flow|Gel Vehicle|Gel Vehicle for up to 8 weeks
10921761|NCT00670241|OG000|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
10921762|NCT00670241|OG001|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
10921763|NCT00670241|OG002|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
10921764|NCT00670241|EG000|Reported Event|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
10921765|NCT00670241|EG001|Reported Event|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
10921766|NCT00670241|EG002|Reported Event|Gel Vehicle|Gel Vehicle for up to 8 weeks
10921767|NCT00670267|BG000|Baseline|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
10921768|NCT00670267|FG000|Participant Flow|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
10921769|NCT00670267|OG000|Outcome|Open Label Treatment With Oral Nadolol|"Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.~nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in."
10921770|NCT00670267|OG000|Outcome|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
10921771|NCT00670267|OG000|Outcome|Open Label Treatment With Oral Nadolol|
10921772|NCT00670267|EG000|Reported Event|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
10921773|NCT00670306|BG000|Baseline|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
10921774|NCT00670306|FG000|Participant Flow|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
10921775|NCT00670306|OG000|Outcome|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
10921776|NCT00670306|EG000|Reported Event|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
10921777|NCT00670449|BG000|Baseline|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
10921778|NCT00670449|BG001|Baseline|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
10921779|NCT00670449|BG002|Baseline|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
10921780|NCT00670449|BG003|Baseline|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
10921781|NCT00670449|BG004|Baseline|Total|Total of all reporting groups
10921782|NCT00670449|FG000|Participant Flow|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
10921783|NCT00670449|FG001|Participant Flow|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
10921784|NCT00670449|FG002|Participant Flow|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
10921785|NCT00670449|FG003|Participant Flow|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
10921786|NCT00670449|OG000|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
10921787|NCT00670449|OG001|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
10921788|NCT00670449|OG002|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
10921789|NCT00670449|EG000|Reported Event|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
10921790|NCT00670449|EG001|Reported Event|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
10921791|NCT00670449|EG002|Reported Event|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
10921792|NCT00670449|EG003|Reported Event|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
10921793|NCT00670462|BG000|Baseline|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
10921794|NCT00670462|BG001|Baseline|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
10921795|NCT00670462|BG002|Baseline|Total|Total of all reporting groups
11191911|NCT02135107|FG002|Participant Flow|Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily|Rabeprazole 10 mg or 20 mg was administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
10921796|NCT00670462|FG000|Participant Flow|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
10921797|NCT00670462|FG001|Participant Flow|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
10921798|NCT00670462|OG000|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
10921799|NCT00670462|OG001|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
10921800|NCT00670462|OG000|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
10921801|NCT00670462|OG001|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
10921802|NCT00670462|EG000|Reported Event|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
10921803|NCT00670462|EG001|Reported Event|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
10921804|NCT00670488|BG000|Baseline|MK-2206 30 mg QOD|Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
10921805|NCT00670488|BG001|Baseline|MK-2206 60 mg QOD|Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921806|NCT00670488|BG002|Baseline|MK-2206 75 mg QOD|Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921807|NCT00670488|BG003|Baseline|MK-2206 90 mg QOD|Participants receive 90 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921808|NCT00670488|BG004|Baseline|MK-2206 90 mg QW|Participants receive 90 mg oral MK-2206 every week (QW) in repeating 4-week treatment cycles.
11175106|NCT02027376|OG000|Outcome|LDE225 (Sonidegib) in Combination With Docetaxel|Eligible patients were included and treated with docetaxel intravenously (75mg/m2)in every three weeks cycles and LDE225 will be administered orally at three dose levels 400, 600 and 800mg QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
10921809|NCT00670488|BG005|Baseline|MK-2206 135 mg QW|Participants receive 135 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921810|NCT00670488|BG006|Baseline|MK-2206 200 mg QW|Participants receive 200 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921811|NCT00670488|BG007|Baseline|MK-2206 300 mg QW|Participants receive 300 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921812|NCT00670488|BG008|Baseline|MK-2206 250 mg QW|Participants receive 250 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921813|NCT00670488|BG009|Baseline|MK-2206 150 mg QW|Participants receive 150 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921814|NCT00670488|BG010|Baseline|Total|Total of all reporting groups
10921815|NCT00670488|FG000|Participant Flow|MK-2206 30 mg QOD|Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
10921816|NCT00670488|FG001|Participant Flow|MK-2206 60 mg QOD|Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921817|NCT00670488|FG002|Participant Flow|MK-2206 75 mg QOD|Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921818|NCT00670488|FG003|Participant Flow|MK-2206 90 mg QOD|Participants receive 90 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921819|NCT00670488|FG004|Participant Flow|MK-2206 90 mg QW|Participants receive 90 mg oral MK-2206 every week (QW) in repeating 4-week treatment cycles.
11191912|NCT02135107|FG003|Participant Flow|Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily|Rabeprazole 10 mg or 20 mg was administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
10921820|NCT00670488|FG005|Participant Flow|MK-2206 135 mg QW|Participants receive 135 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921821|NCT00670488|FG006|Participant Flow|MK-2206 200 mg QW|Participants receive 200 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921822|NCT00670488|FG007|Participant Flow|MK-2206 300 mg QW|Participants receive 300 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921823|NCT00670488|FG008|Participant Flow|MK-2206 250 mg QW|Participants receive 250 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921824|NCT00670488|FG009|Participant Flow|MK-2206 150 mg QW|Participants receive 150 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921825|NCT00670488|OG000|Outcome|MK-2206 30 mg QOD|Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
10921826|NCT00670488|OG001|Outcome|MK-2206 60 mg QOD|Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921827|NCT00670488|OG002|Outcome|MK-2206 75 mg QOD|Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921828|NCT00670488|OG003|Outcome|MK-2206 90 mg QOD|Participants receive 90 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921829|NCT00670488|OG004|Outcome|MK-2206 90 mg QW|Participants receive 90 mg oral MK-2206 every week (QW) in repeating 4-week treatment cycles.
10921830|NCT00670488|OG005|Outcome|MK-2206 135 mg QW|Participants receive 135 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921831|NCT00670488|OG006|Outcome|MK-2206 200 mg QW|Participants receive 200 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921832|NCT00670488|OG007|Outcome|MK-2206 300 mg QW|Participants receive 300 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921833|NCT00670488|OG008|Outcome|MK-2206 250 mg QW|Participants receive 250 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921834|NCT00670488|OG009|Outcome|MK-2206 150 mg QW|Participants receive 150 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921835|NCT00670488|EG000|Reported Event|MK-2206 30 mg QOD|Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
10921836|NCT00670488|EG001|Reported Event|MK-2206 60 mg QOD|Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921837|NCT00670488|EG002|Reported Event|MK-2206 75 mg QOD|Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921838|NCT00670488|EG003|Reported Event|MK-2206 90 mg QOD|Participants receive 90 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
10921839|NCT00670488|EG004|Reported Event|MK-2206 90 mg QW|Participants receive 90 mg oral MK-2206 every week (QW) in repeating 4-week treatment cycles.
10921840|NCT00670488|EG005|Reported Event|MK-2206 135 mg QW|Participants receive 135 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921841|NCT00670488|EG006|Reported Event|MK-2206 200 mg QW|Participants receive 200 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921842|NCT00670488|EG007|Reported Event|MK-2206 300 mg QW|Participants receive 300 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921843|NCT00670488|EG008|Reported Event|MK-2206 250 mg QW|Participants receive 250 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921844|NCT00670488|EG009|Reported Event|MK-2206 150 mg QW|Participants receive 150 mg oral MK-2206 QW in repeating 4-week treatment cycles.
10921845|NCT00670540|BG000|Baseline|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
10921846|NCT00670540|FG000|Participant Flow|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
10921847|NCT00670540|OG000|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
10921848|NCT00670540|EG000|Reported Event|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
10921849|NCT00670709|BG000|Baseline|Huntington Disease|Subjects with mild or moderate Huntington's Disease
10921850|NCT00670709|BG001|Baseline|Healthy Controls|Healthy control subjects
10921851|NCT00670709|BG002|Baseline|Total|Total of all reporting groups
10921852|NCT00670709|FG000|Participant Flow|Huntington Disease|Subjects with mild or moderate Huntington's Disease
10921853|NCT00670709|FG001|Participant Flow|Healthy Controls|Healthy control subjects
10921854|NCT00670709|OG000|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
10921855|NCT00670709|OG001|Outcome|Healthy Controls|Healthy control subjects
10921856|NCT00670709|EG000|Reported Event|Huntington Disease|Subjects with mild or moderate Huntington's Disease
10921857|NCT00670709|EG001|Reported Event|Healthy Controls|Healthy control subjects
10921858|NCT00670748|BG000|Baseline|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
10921859|NCT00670748|BG001|Baseline|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
10921860|NCT00670748|BG002|Baseline|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
10921861|NCT00670748|BG003|Baseline|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
10921862|NCT00670748|BG004|Baseline|Total|Total of all reporting groups
10921863|NCT00670748|FG000|Participant Flow|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
10921864|NCT00670748|FG001|Participant Flow|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
10921865|NCT00670748|FG002|Participant Flow|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
10964054|NCT00875615|OG000|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
10921866|NCT00670748|FG003|Participant Flow|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
11175107|NCT02027376|OG000|Outcome|LDE225 (Sonidegib) in Combination With Docetaxel|Eligible patients will be included and treated with docetaxel intravenously (75mg/m2)in every three weeks cycles and LDE225 will be administered orally at three dose levels 400, 600 and 800mg QD. Treatment will be repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
11175108|NCT02027376|EG000|Reported Event|LDE225 (Sonidegib) 400mg in Combination With Docetaxel|Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally one a day. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
11175109|NCT02027376|EG001|Reported Event|LDE225 (Sonidegib) 600mg in Combination With Docetaxel|Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally one a day. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
11175110|NCT02027376|EG002|Reported Event|LDE225 (Sonidegib) 800mg in Combination With Docetaxel|Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally one a day. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
11175111|NCT02027402|BG000|Baseline|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
11175112|NCT02027402|BG001|Baseline|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
11175113|NCT02027402|BG002|Baseline|Total|Total of all reporting groups
11175114|NCT02027402|FG000|Participant Flow|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
11175115|NCT02027402|FG001|Participant Flow|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
11175116|NCT02027402|OG000|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
11175117|NCT02027402|OG001|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
11175118|NCT02027402|OG000|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
11175119|NCT02027402|OG001|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
11175120|NCT02027402|EG000|Reported Event|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
11175121|NCT02027402|EG001|Reported Event|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
11175122|NCT02027428|BG000|Baseline|Nab-Paclitaxel + Best Supportive Care (BSC)|Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.
11175123|NCT02027428|BG001|Baseline|Best Supportive Care (BSC)|Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
11175124|NCT02027428|BG002|Baseline|Total|Total of all reporting groups
11175125|NCT02027428|FG000|Participant Flow|All Participants - Induction|During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had radiological or clinical progressive disease (PD), they were discontinued from the study and not followed. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she were eligible to be randomised to the maintenance phase
11175126|NCT02027428|FG001|Participant Flow|Nab-Paclitaxel + Best Supportive Care (BSC)|Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.
11175127|NCT02027428|FG002|Participant Flow|Best Supportive Care (BSC)|Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
11175128|NCT02027428|OG000|Outcome|Nab-Paclitaxel + Best Supportive Care (BSC)|Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.
11175129|NCT02027428|OG001|Outcome|Best Supportive Care (BSC)|Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
11175130|NCT02027428|OG000|Outcome|Nab-Paclitaxel + BSC: Induction + Maintenance|Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.
11175131|NCT02027428|OG001|Outcome|BSC: Induction + Maintenance|Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
11175132|NCT02027428|OG000|Outcome|All Participants - Induction|During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had radiological or clinical progressive disease (PD), they were discontinued from the study and not followed. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she were eligible to be randomised to the maintenance phase
11175133|NCT02027428|OG001|Outcome|Nab-Paclitaxel + BSC: Induction + Maintenance|Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.
11191913|NCT02135107|OG000|Outcome|Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily|Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
10921867|NCT00670748|OG000|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
10921868|NCT00670748|OG001|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
10921869|NCT00670748|OG002|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
10921870|NCT00670748|OG003|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
10921871|NCT00670748|EG000|Reported Event|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
10921872|NCT00670748|EG001|Reported Event|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
10921873|NCT00670748|EG002|Reported Event|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
10921874|NCT00670748|EG003|Reported Event|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
10921875|NCT00670774|BG000|Baseline|Eculizumab|Patients received eculizumab intravenously according to details provided in the intervention description.
10921876|NCT00670774|FG000|Participant Flow|Eculizumab|Patients received eculizumab intravenously according to details provided in the intervention description.
10921877|NCT00670774|OG000|Outcome|Eculizumab|Patients received eculizumab intravenously according to details provided in the intervention description.
10921878|NCT00670774|EG000|Reported Event|Eculizumab|Patients received eculizumab intravenously according to details provided in the intervention description.
10921879|NCT00670800|BG000|Baseline|PCOS Affected Women - Metformin|Right handed women who don't smoke and who drink very little will be considered eligible. Women with the following conditions (exclusion criteria) may not participate: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics).
10921880|NCT00670800|BG001|Baseline|Normal Controls|Normal controls are matched for age and education and screened for insulin resistance. Controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles, and lack hirsutism and acne. Exclusion criteria: Left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, claustrophobia, contraindications to MRI (including pacemakers, pumps, surgical clips or metallic surgical devices), smoking within the last 6 months, use of hormones or insulin sensitizing mediation within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids, cardiac or pulmonary insufficiency, active liver disease and transaminases elevations >2.5 X normal values, renal insufficiency (plasma creatinine level ≥1.4 mg/dl), use of centrally acting medications, allergy to any opioid medication, 300 lbs maximum weight limit (which is the max
10921881|NCT00670800|BG002|Baseline|Total|Total of all reporting groups
10921882|NCT00670800|FG000|Participant Flow|Women Affected With PCOS - Metformin|The Polycystic Ovary Syndrome (PCOS) affected group is comprised of subjects with insulin resistant PCOS, defined as having irregular menstrual cycles and hyperandrogenism with other causes ruled out. Insulin resistance will be identified as fasting homeostasis model assessment insulin resistance (HOMA2-IR) of 60%S or less.
11191914|NCT02135107|OG001|Outcome|Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily|Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
10921883|NCT00670800|FG001|Participant Flow|Women Controls Without PCOS|"Control group is comprised of subjects without PCOS. These women have normal menstrual cycles and no evidence of insulin resistance (fasting HOMA2 IR of 80%S or more).~.~Exclusion criteria: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics)."
10921884|NCT00670800|OG000|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
10921885|NCT00670800|OG001|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
10921886|NCT00670800|OG002|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
10921887|NCT00670800|OG002|Outcome|Normal Control Women|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
10921888|NCT00670800|EG000|Reported Event|Normal Controls|Women without PCOS
10921889|NCT00670800|EG001|Reported Event|PCOS Affected Women on Metformin|Women with PCOS and insulin resistance
10921890|NCT00670930|BG000|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
10921891|NCT00670930|BG001|Baseline|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
10921892|NCT00670930|BG002|Baseline|Total|Total of all reporting groups
10921893|NCT00670930|FG000|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
10921894|NCT00670930|FG001|Participant Flow|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
10921895|NCT00670930|OG000|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
10921896|NCT00670930|OG001|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
10921897|NCT00670930|EG000|Reported Event|Omalizumab|Omalizumab
10921898|NCT00670930|EG001|Reported Event|Placebo|Placebo
10921899|NCT00670956|BG000|Baseline|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
10921900|NCT00670956|FG000|Participant Flow|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
10921901|NCT00670956|OG000|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
10921902|NCT00670956|EG000|Reported Event|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
10921903|NCT00670982|BG000|Baseline|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
10921904|NCT00670982|BG001|Baseline|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
10921905|NCT00670982|BG002|Baseline|Total|Total of all reporting groups
10921906|NCT00670982|FG000|Participant Flow|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every 2 weeks and vinorelbine(25mg/m2) intravenously once per week, and trastuzumab (4 mg/kg) intravenously once per week
10921907|NCT00670982|FG001|Participant Flow|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every two weeks, vinorelbine (25mg/m2) intravenously once per week, and trastuzumab(4 mg/kg) intravenously once per week.
10921908|NCT00670982|OG000|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
10921909|NCT00670982|OG001|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
10921910|NCT00670982|EG000|Reported Event|All Study Participants|All participants received the same study treatment, so cumulative adverse events are reported here.
10921911|NCT00671034|BG000|Baseline|Arm I (Calaspargase Pegol 2100)|calaspargase pegol 2100
10921912|NCT00671034|BG001|Baseline|Arm II (Calaspargase Pegol 2500)|calaspargase pegol 2500
10921913|NCT00671034|BG002|Baseline|Arm III (Pegaspargase 2500)|pegaspargase 2500
10921914|NCT00671034|BG003|Baseline|Total|Total of all reporting groups
10921915|NCT00671034|FG000|Participant Flow|Arm I (Calaspargase Pegol 2100)|Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
10921916|NCT00671034|FG001|Participant Flow|Arm II (Calaspargase Pegol 2500)|Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
11191915|NCT02135107|OG000|Outcome|Rabeprazole: 10 mg Twice Daily|Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
10921917|NCT00671034|FG002|Participant Flow|Arm III (Pegaspargase 2500)|Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
10921918|NCT00671034|OG000|Outcome|Arm I (Calaspargase Pegol 2100)|Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
10921919|NCT00671034|OG001|Outcome|Arm II ( Calaspargase Pegol 2500)|Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
10921920|NCT00671034|OG002|Outcome|Arm III (Pegaspargase 2500)|Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
10921921|NCT00671034|OG001|Outcome|Arm II (Calaspargase Pegol 2500)|Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
10921922|NCT00671034|EG000|Reported Event|Arm I (Calaspargase Pegol 2100)|calaspargase pegol 2100
10921923|NCT00671034|EG001|Reported Event|Arm II (Calaspargase Pegol 2500)|calaspargase pegol 2500
10921924|NCT00671034|EG002|Reported Event|Arm III (Pegaspargase 2500)|pegaspargase 2500
10921925|NCT00671060|BG000|Baseline|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
10921926|NCT00671060|BG001|Baseline|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
10921927|NCT00671060|BG002|Baseline|Total|Total of all reporting groups
10921928|NCT00671060|FG000|Participant Flow|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
10921929|NCT00671060|FG001|Participant Flow|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
11191916|NCT02135107|OG001|Outcome|Rabeprazole: 20 mg Twice Daily|Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
10921930|NCT00671060|OG000|Outcome|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
10921931|NCT00671060|OG001|Outcome|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
10921932|NCT00671060|EG000|Reported Event|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
10921933|NCT00671060|EG001|Reported Event|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
10921934|NCT00671177|BG000|Baseline|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
10921935|NCT00671177|BG001|Baseline|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
10921936|NCT00671177|BG002|Baseline|Total|Total of all reporting groups
10921937|NCT00671177|FG000|Participant Flow|Water Immersion Colonoscopy|"Water Immersion Colonoscopy~water immersion colonoscopy: instillation of 300cc of water in the rectum"
10921938|NCT00671177|FG001|Participant Flow|Standard Air Colonoscopy|"Standard Air Colonoscopy~standard air colonoscopy: air instillation in colon for visualization"
10921939|NCT00671177|OG000|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
10921940|NCT00671177|OG001|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
10921941|NCT00671177|EG000|Reported Event|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
10921942|NCT00671177|EG001|Reported Event|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
10921943|NCT00671437|BG000|Baseline|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
10921944|NCT00671437|FG000|Participant Flow|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
10921945|NCT00671437|OG000|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
11191917|NCT02135107|OG002|Outcome|Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C|Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
10921946|NCT00671437|OG000|Outcome|Partial Metabolic Response (Overall PET Response)|
10921947|NCT00671437|OG001|Outcome|Stable Metabolic Disease (Overall PET Response)|
10921948|NCT00671437|OG002|Outcome|Progressive Metabolic Disease (Overall PET Response)|
10921949|NCT00671437|OG003|Outcome|Total (Overall PET Response)|
10921950|NCT00671437|OG000|Outcome|Disease Control by CT and PET/CT|
10921951|NCT00671437|OG001|Outcome|Disease Control by CT and Progressive Disease by PET/CT|
10921952|NCT00671437|OG002|Outcome|Progressive Disease by Both CT and PET/CT|
10921953|NCT00671437|OG000|Outcome|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
10921954|NCT00671437|EG000|Reported Event|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
10921955|NCT00671502|BG000|Baseline|Carisoprodol 700mg|tablet experimental formulation
11191918|NCT02135107|OG003|Outcome|Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily|Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
10921956|NCT00671502|BG001|Baseline|Carisoprodol 500mg Tablet|tablet experimental formulation
10921957|NCT00671502|BG002|Baseline|Placebo Tablet|tablet placebo no experimental formulation
10921958|NCT00671502|BG003|Baseline|Total|Total of all reporting groups
10921959|NCT00671502|FG000|Participant Flow|Carisoprodol 700mg|tablet experimental formulation
10921960|NCT00671502|FG001|Participant Flow|Carisoprodol 500mg Tablet|tablet experimental formulation
10921961|NCT00671502|FG002|Participant Flow|Placebo Tablet|tablet placebo no experimental formulation
10921962|NCT00671502|OG000|Outcome|Carisoprodol 500mg Tablets|carisoprodol 500mg tablets treatment arm
10921963|NCT00671502|OG001|Outcome|Carisoprodol 700mg Tablets|carisoprodol 700mg tablets treatment arm
10921964|NCT00671502|OG002|Outcome|Placebo Tablets|placebo tablets treatment arm
10921965|NCT00671502|EG000|Reported Event|Carisoprodol 700mg|tablet experimental formulation
10921966|NCT00671502|EG001|Reported Event|Carisoprodol 500mg Tablet|tablet experimental formulation
10921967|NCT00671502|EG002|Reported Event|Placebo Tablet|tablet placebo no experimental formulation
10921968|NCT00671515|BG000|Baseline|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
10921969|NCT00671515|FG000|Participant Flow|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
10921970|NCT00671515|OG000|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
10921971|NCT00671515|EG000|Reported Event|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
10921972|NCT00671554|BG000|Baseline|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
10921973|NCT00671554|FG000|Participant Flow|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG). Four 1 ml doses of 250,000 dendritomas Subcutaneous (SQ) at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
10921974|NCT00671554|OG000|Outcome|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
10921975|NCT00671554|OG000|Outcome|Melaxin and BCG|"Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration~Melaxin (autologous dendritoma vaccine) and BCG: Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration."
10921976|NCT00671554|EG000|Reported Event|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
10921977|NCT00671658|BG000|Baseline|HYPER-CVAD|Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide (CTX) 300 mg/m^2 IV, Doxorubicin 50 mg/m^2 IV, Vincristine 2 mg IV, Dexamethasone 40 mg IV or oral (PO). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m^2 IV followed by 800 mg/m^2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m^2 IV for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m^2 a day IV, Pegylated asparaginase 2000 International units/m^2 IV. Pegfilgrastim 6 mg (flat dose) within 72 hours after completion of chemotherapy. Solumedrol 40 mg IV for Courses 2,4,6,8.
10921978|NCT00671658|FG000|Participant Flow|HYPER-CVAD|Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide (CTX) 300 mg/m^2 IV, Doxorubicin 50 mg/m^2 IV, Vincristine 2 mg IV, Dexamethasone 40 mg IV or oral (PO). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m^2 IV followed by 800 mg/m^2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m^2 IV for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m^2 a day IV, Pegylated asparaginase 2000 International units/m^2 IV. Pegfilgrastim 6 mg (flat dose) within 72 hours after completion of chemotherapy. Solumedrol 40 mg IV for Courses 2,4,6,8.
10921979|NCT00671658|OG000|Outcome|HYPER-CVAD|Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide (CTX) 300 mg/m^2 IV, Doxorubicin 50 mg/m^2 IV, Vincristine 2 mg IV, Dexamethasone 40 mg IV or oral (PO). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m^2 IV followed by 800 mg/m^2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m^2 IV for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m^2 a day IV, Pegylated asparaginase 2000 International units/m^2 IV. Pegfilgrastim 6 mg (flat dose) within 72 hours after completion of chemotherapy. Solumedrol 40 mg IV for Courses 2,4,6,8.
10921980|NCT00671658|EG000|Reported Event|HYPER-CVAD|Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide (CTX) 300 mg/m^2 IV, Doxorubicin 50 mg/m^2 IV, Vincristine 2 mg IV, Dexamethasone 40 mg IV or oral (PO). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m^2 IV followed by 800 mg/m^2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m^2 IV for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m^2 a day IV, Pegylated asparaginase 2000 International units/m^2 IV. Pegfilgrastim 6 mg (flat dose) within 72 hours after completion of chemotherapy. Solumedrol 40 mg IV for Courses 2,4,6,8.
10921981|NCT00671671|BG000|Baseline|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
11191919|NCT02135107|EG000|Reported Event|Rabeprazole: 10 mg Twice Daily|Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
11191920|NCT02135107|EG001|Reported Event|Rabeprazole: 20 mg Twice Daily|Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
11191921|NCT02135107|EG002|Reported Event|Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily|Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
10921982|NCT00671671|BG001|Baseline|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
10921983|NCT00671671|BG002|Baseline|Total|Total of all reporting groups
10921984|NCT00671671|FG000|Participant Flow|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
10921985|NCT00671671|FG001|Participant Flow|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
10921986|NCT00671671|OG000|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
10921987|NCT00671671|OG000|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
10921988|NCT00671671|OG001|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
10921989|NCT00671671|EG000|Reported Event|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
10921990|NCT00671671|EG001|Reported Event|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
10921991|NCT00671723|BG000|Baseline|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10921992|NCT00671723|BG001|Baseline|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10921993|NCT00671723|BG002|Baseline|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10921994|NCT00671723|BG003|Baseline|Total|Total of all reporting groups
11175134|NCT02027428|OG002|Outcome|BSC: Induction + Maintenance|Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
11175135|NCT02027428|OG001|Outcome|Nab-Paclitaxel + BSC: Induction + Maintenance|Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.
11175136|NCT02027428|OG001|Outcome|TEAE Specific to Nab-Paclitaxel|TEAE categories specific to nab-paclitaxel intervention as determined by the investigator.
10921995|NCT00671723|FG000|Participant Flow|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10921996|NCT00671723|FG001|Participant Flow|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10921997|NCT00671723|FG002|Participant Flow|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10921998|NCT00671723|OG000|Outcome|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10921999|NCT00671723|OG001|Outcome|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10922000|NCT00671723|OG002|Outcome|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
11175137|NCT02027428|OG002|Outcome|TEAE Specific to Carboplatin|TEAE categories specific to carboplatin intervention as determined by the investigator.
11175138|NCT02027428|OG000|Outcome|Nab-Paclitaxel + BSC: Induction + Maintenance|Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.
11175139|NCT02027428|OG001|Outcome|Nab-Paclitaxel + BSC: TEAE Specific to Nab-Paclitaxel|TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. Nab-paclitaxel was administered during Induction and Maintenance.
11175140|NCT02027428|OG002|Outcome|Nab-Paclitaxel + BSC: TEAE Specific to Carboplatin|TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. Carboplatin was administered during Induction.
11175141|NCT02027428|OG003|Outcome|Nab-Paclitaxel + BSC: TEAE Specific to BSC|TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.
11175142|NCT02027428|OG004|Outcome|BSC: Induction + Maintenance|Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
11175143|NCT02027428|OG005|Outcome|BSC: TEAE Specific to Nab-Paclitaxel|TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.
11175144|NCT02027428|OG006|Outcome|BSC: TEAE Specific to Carboplatin|TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.
11175145|NCT02027428|OG007|Outcome|BSC: TEAE Specific to BSC|TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
11175146|NCT02027428|EG000|Reported Event|All Participants - Induction|During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had radiological or clinical progressive disease (PD), they were discontinued from the study and not followed. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she were eligible to be randomised to the maintenance phase
11175147|NCT02027428|EG001|Reported Event|Nab-Paclitaxel + Best Supportive Care (Maintenance)|Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.
11357621|NCT03752528|OG003|Outcome|Part B Cohort: Visit 3|Part A participants with a quantifiable (i.e. positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e. negative) result for naloxone continue in the study for two additional visits (Part B, Visits 2 and 3). This cohort reports Visit 3 (Day 60) results for those participants who continued into Part B of the study.
10922001|NCT00671723|EG000|Reported Event|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
11175148|NCT02027428|EG002|Reported Event|Best Supportive Care (Maintenance)|Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
11175149|NCT02027545|BG000|Baseline|Decision Aid|"Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.~A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.~The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.~Providers were given information about recent data on the benefits and harms of screening & how these data fit in with existing population-centered guidelines."
10922002|NCT00671723|EG001|Reported Event|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10922003|NCT00671723|EG002|Reported Event|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
10922004|NCT00671749|BG000|Baseline|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
10922005|NCT00671749|FG000|Participant Flow|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
10922006|NCT00671749|OG000|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
10922007|NCT00671749|EG000|Reported Event|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
10922008|NCT00671788|BG000|Baseline|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
10922009|NCT00671788|FG000|Participant Flow|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
10922010|NCT00671788|OG000|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
10922011|NCT00671788|EG000|Reported Event|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
11175150|NCT02027545|BG001|Baseline|No Decision Aid|"Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3) provider education.~A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.~The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.~Providers were given information about recent data on the benefits and harms of screening & how these data fit in with existing population-centered guidelines."
11175151|NCT02027545|BG002|Baseline|Total|Total of all reporting groups
11175152|NCT02027545|FG000|Participant Flow|Decision Aid|"Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.~A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.~The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.~Providers were given information about recent data on the benefits and harms of screening & how these data fit in with existing population-centered guidelines."
11191922|NCT02135107|EG003|Reported Event|Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily|Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
11191923|NCT02135146|BG000|Baseline|Plasmalyte 3ml/kg/hr Group|Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
10922012|NCT00671853|BG000|Baseline|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
10922013|NCT00671853|BG001|Baseline|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
10922014|NCT00671853|BG002|Baseline|Total|Total of all reporting groups
10922015|NCT00671853|FG000|Participant Flow|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
10922016|NCT00671853|FG001|Participant Flow|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
10922017|NCT00671853|OG000|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
10922018|NCT00671853|OG001|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
10922019|NCT00671853|OG000|Outcome|Quetiapine XR|
10922020|NCT00671853|OG001|Outcome|Placebo for Quetiapine XR|
10922021|NCT00671853|EG000|Reported Event|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
10922022|NCT00671853|EG001|Reported Event|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
10922023|NCT00671879|BG000|Baseline|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
10922024|NCT00671879|BG001|Baseline|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
10922025|NCT00671879|BG002|Baseline|Placebo|Placebo treatment arm
10922026|NCT00671879|BG003|Baseline|Total|Total of all reporting groups
10922027|NCT00671879|FG000|Participant Flow|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
10922028|NCT00671879|FG001|Participant Flow|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
10922029|NCT00671879|FG002|Participant Flow|Placebo|Placebo treatment arm
10922030|NCT00671879|OG000|Outcome|Carisprodol SR 700 mg|Carisoprodol SR 700 mg twice daily
10922031|NCT00671879|OG001|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
10922032|NCT00671879|OG002|Outcome|Placebo|Placebo treatment arm
10922033|NCT00671879|OG000|Outcome|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
10922034|NCT00671879|EG000|Reported Event|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
11191924|NCT02135146|BG001|Baseline|Plasmalyte 6ml/kg/hr Group|Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
10922035|NCT00671879|EG001|Reported Event|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
10922036|NCT00671879|EG002|Reported Event|Placebo|Placebo treatment arm
10922037|NCT00671918|BG000|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
10922038|NCT00671918|FG000|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc-99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
10922039|NCT00671918|OG000|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
10922040|NCT00671918|OG000|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
10922041|NCT00671918|EG000|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
10922042|NCT00671931|BG000|Baseline|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922043|NCT00671931|BG001|Baseline|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922044|NCT00671931|BG002|Baseline|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10964055|NCT00875615|EG000|Reported Event|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
11191925|NCT02135146|BG002|Baseline|Total|Total of all reporting groups
11191926|NCT02135146|FG000|Participant Flow|Plasmalyte 3ml/kg/hr Group|Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
10922045|NCT00671931|BG003|Baseline|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922046|NCT00671931|BG004|Baseline|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922047|NCT00671931|BG005|Baseline|Total|Total of all reporting groups
10922048|NCT00671931|FG000|Participant Flow|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922049|NCT00671931|FG001|Participant Flow|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922050|NCT00671931|FG002|Participant Flow|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922051|NCT00671931|FG003|Participant Flow|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922052|NCT00671931|FG004|Participant Flow|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922053|NCT00671931|OG000|Outcome|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
11191927|NCT02135146|FG001|Participant Flow|Plasmalyte 6ml/kg/hr Group|Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
10922054|NCT00671931|OG001|Outcome|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922055|NCT00671931|OG002|Outcome|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922056|NCT00671931|OG003|Outcome|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922057|NCT00671931|OG004|Outcome|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922058|NCT00671931|EG000|Reported Event|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922059|NCT00671931|EG001|Reported Event|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922060|NCT00671931|EG002|Reported Event|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922061|NCT00671931|EG003|Reported Event|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
11191928|NCT02135146|OG000|Outcome|Plasmalyte 3ml/kg/hr Group|Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
11191929|NCT02135146|OG001|Outcome|Plasmalyte 6ml/kg/hr Group|Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
11191930|NCT02135146|EG000|Reported Event|Plasmalyte 3ml/kg/hr Group|Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
10922062|NCT00671931|EG004|Reported Event|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
10922063|NCT00671970|BG000|Baseline|Who Grade III|Who Grade III Malignant Glioma
10922064|NCT00671970|BG001|Baseline|WHO Grade IV|WHO Grade IV Malignant Glioma
10922065|NCT00671970|BG002|Baseline|Total|Total of all reporting groups
10922066|NCT00671970|FG000|Participant Flow|WHO Grade III|"WHO Grade III Malignant Glioma~Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
10922067|NCT00671970|FG001|Participant Flow|WHO Grade IV|"WHO Grade IV Malignant Glioma~Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
10922068|NCT00671970|OG000|Outcome|Who Grade III|Who Grade III Malignant Glioma
10922069|NCT00671970|OG001|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
10922070|NCT00671970|OG000|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
10922071|NCT00671970|OG000|Outcome|Positive Expression|EGFR positive expression
10922072|NCT00671970|OG001|Outcome|Negative Expression|EGFR negative expression
10922073|NCT00671970|OG000|Outcome|Positive Expression|EGFR vIII positive expression
10922074|NCT00671970|OG001|Outcome|Negative Expression|EGFR vIII negative expression
10922075|NCT00671970|OG000|Outcome|Intact|PTEN Intact
10922076|NCT00671970|OG001|Outcome|Loss|PTEN Loss
10922077|NCT00671970|OG000|Outcome|Positive Expression|pAKT positive expression
10922078|NCT00671970|OG001|Outcome|Negative Expression|pAKT negative expression
10922079|NCT00671970|OG000|Outcome|Positive Expression|pMAPK positive expression
10922080|NCT00671970|OG001|Outcome|Negative Expression|pMAPK negative expression
10922081|NCT00671970|OG000|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
11175153|NCT02027545|FG001|Participant Flow|No Decision Aid|"Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.~A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.~The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.~Providers were given information about recent data on the benefits and harms of screening & how these data fit in with existing population-centered guidelines."
11191931|NCT02135146|EG001|Reported Event|Plasmalyte 6ml/kg/hr Group|Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
11191932|NCT02135432|BG000|Baseline|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
10922082|NCT00671970|OG001|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
10922083|NCT00671970|EG000|Reported Event|All Patients|All Patients
10922084|NCT00672100|BG000|Baseline|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922085|NCT00672100|BG001|Baseline|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922086|NCT00672100|BG002|Baseline|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922087|NCT00672100|BG003|Baseline|Total|Total of all reporting groups
10922088|NCT00672100|FG000|Participant Flow|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922089|NCT00672100|FG001|Participant Flow|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922090|NCT00672100|FG002|Participant Flow|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
11191933|NCT02135432|BG001|Baseline|Placebo|"matching placebo~Placebo"
11191934|NCT02135432|BG002|Baseline|Total|Total of all reporting groups
10922091|NCT00672100|OG000|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922092|NCT00672100|OG001|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922093|NCT00672100|OG002|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922094|NCT00672100|OG000|Outcome|Ropivacaine 5 mL|
10922095|NCT00672100|OG001|Outcome|Ropivacaine 10 mL|
10922096|NCT00672100|OG002|Outcome|Ropivacaine 20 mL|
10922097|NCT00672100|OG000|Outcome|All Study Participants|All study participants who received Interscalene block (ISB) using 5-20 mL of local anesthetic.
10922098|NCT00672100|EG000|Reported Event|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922099|NCT00672100|EG001|Reported Event|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922100|NCT00672100|EG002|Reported Event|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
10922101|NCT00672139|BG000|Baseline|Methylnaltrexone Bromide 8 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
10922102|NCT00672139|BG001|Baseline|Methylnaltrexone Bromide 12 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
10922103|NCT00672139|BG002|Baseline|Total|Total of all reporting groups
10922104|NCT00672139|FG000|Participant Flow|Methylnaltrexone Bromide 8 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
10922105|NCT00672139|FG001|Participant Flow|Methylnaltrexone Bromide 12 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
10922106|NCT00672139|OG000|Outcome|Methylnaltrexone Bromide 8 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
10922107|NCT00672139|OG001|Outcome|Methylnaltrexone Bromide 12 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
10922108|NCT00672139|EG000|Reported Event|Methylnaltrexone Bromide 8 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
10922109|NCT00672139|EG001|Reported Event|Methylnaltrexone Bromide 12 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
10922110|NCT00672204|BG000|Baseline|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
11191935|NCT02135432|FG000|Participant Flow|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
11191936|NCT02135432|FG001|Participant Flow|Placebo|"matching placebo~Placebo"
11191937|NCT02135432|OG000|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
11191938|NCT02135432|OG001|Outcome|Placebo|"matching placebo~Placebo"
11191939|NCT02135432|OG000|Outcome|Ivacaftor|patients randomized to ivacaftor twice daily
11191940|NCT02135432|EG000|Reported Event|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
11191941|NCT02135432|EG001|Reported Event|Placebo|"matching placebo~Placebo"
10922111|NCT00672204|FG000|Participant Flow|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
10922112|NCT00672204|OG000|Outcome|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
10922113|NCT00672204|EG000|Reported Event|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
10922114|NCT00672243|BG000|Baseline|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
11175154|NCT02027545|OG000|Outcome|Decision Aid|"Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.~A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.~The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.~Providers were given information about recent data on the benefits and harms of screening & how these data fit in with existing population-centered guidelines."
11175155|NCT02027545|OG001|Outcome|No Decision Aid|"Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.~A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.~The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.~Providers were given information about recent data on the benefits and harms of screening & how these data fit in with existing population-centered guidelines."
11175156|NCT02027545|EG000|Reported Event|Decision Aid|"Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.~A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.~The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.~Providers were given information about recent data on the benefits and harms of screening & how these data fit in with existing population-centered guidelines."
11175157|NCT02027545|EG001|Reported Event|No Decision Aid|"Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.~A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.~The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.~Providers were given information about recent data on the benefits and harms of screening & how these data fit in with existing population-centered guidelines."
11175158|NCT02027558|BG000|Baseline|Behavioral Treatment|Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence education program provided by allied health personnel in individual sessions.
11175159|NCT02027558|BG001|Baseline|Active Control|Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
11175160|NCT02027558|BG002|Baseline|Total|Total of all reporting groups
11175161|NCT02027558|FG000|Participant Flow|Behavioral Treatment|Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
11175162|NCT02027558|FG001|Participant Flow|Active Control|Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
11175163|NCT02027558|OG000|Outcome|Behavioral Treatment|"Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.~."
11175164|NCT02027558|OG001|Outcome|Active Control|"Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.~."
11175165|NCT02027558|OG000|Outcome|Behavioral Treatment|Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
11357622|NCT03752528|EG000|Reported Event|All Study Participants|All study participants who enrolled into the Part A Cohort. These participants previously participated in study RB-US-13-0003 or both studies RB-US-13-0003 and INDV-6000-301 and who received at least 2 doses of SUBLOCADE 12-36 months prior. Some of the participants continued into study Part B after completing Part A.
11175166|NCT02027558|OG001|Outcome|Active Control|Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
11175167|NCT02027558|EG000|Reported Event|Behavioral Treatment|Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
11175168|NCT02027558|EG001|Reported Event|Active Control|Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
11175169|NCT02027623|BG000|Baseline|Motor Skill Training|"The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.~Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed."
11175170|NCT02027623|BG001|Baseline|Strength and Flexibility Exercise|"The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.~Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed."
11175171|NCT02027623|BG002|Baseline|Total|Total of all reporting groups
11175172|NCT02027623|FG000|Participant Flow|Motor Skill Training|"The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.~Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed."
11175173|NCT02027623|FG001|Participant Flow|Strength and Flexibility Exercise|"The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.~Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed."
11175174|NCT02027623|OG000|Outcome|Motor Skill Training|"The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.~Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed."
11175175|NCT02027623|OG001|Outcome|Strength and Flexibility Exercise|"The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.~Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed."
11191942|NCT02135445|BG000|Baseline|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
11191943|NCT02135445|BG001|Baseline|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
11191944|NCT02135445|BG002|Baseline|Total|Total of all reporting groups
10922115|NCT00672243|FG000|Participant Flow|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3, subfamily A (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
10922116|NCT00672243|OG000|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
10922117|NCT00672243|OG000|Outcome|Tarceva and Rapamycin|
10922118|NCT00672243|EG000|Reported Event|Tarceva and Rapamycin|
10922119|NCT00672256|BG000|Baseline|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
10922120|NCT00672256|FG000|Participant Flow|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
10922121|NCT00672256|OG000|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
11175176|NCT02027623|OG000|Outcome|Motor Skill Training|"The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.~Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. The conditions of practice will vary based on 1) ability to perform the activity, and 2)level of challenge the participant is faced with performing the activity during his day. Equipment will be provided as needed."
10922122|NCT00672256|EG000|Reported Event|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
10922123|NCT00672438|BG000|Baseline|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil prior to a saline placebo infusion. All other procedures were identical in both groups.
10922124|NCT00672438|BG001|Baseline|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil. All other procedures were identical in both groups.
10922125|NCT00672438|BG002|Baseline|Total|Total of all reporting groups
10922126|NCT00672438|FG000|Participant Flow|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil via a computer-controlled infusion targeting steady-state plasma concentration of 100ng/ml prior to a saline placebo infusion. All other procedures were identical in both groups.
10922127|NCT00672438|FG001|Participant Flow|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil via a computer-controlled infusion pump targeting a steady-state plasma concentration of 100ng/ml. All other procedures were identical in both groups.
10922128|NCT00672438|OG000|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
10922129|NCT00672438|OG001|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
10922130|NCT00672438|OG001|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
10922131|NCT00672438|EG000|Reported Event|Alfentanil|Intravenous infusion of Alfentanil
11175177|NCT02027623|EG000|Reported Event|Motor Skill Training|"The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.~Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed."
11175178|NCT02027623|EG001|Reported Event|Strength and Flexibility Exercise|"The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.~Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed."
10922132|NCT00672451|BG000|Baseline|Rhubarb Extract|"will receive rhubarb extract~rhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth"
10922133|NCT00672451|BG001|Baseline|Placebo|"receive placebo~placebo: placebo titrated up to 6 pills daily as patient tolerates"
10922134|NCT00672451|BG002|Baseline|Total|Total of all reporting groups
10922135|NCT00672451|FG000|Participant Flow|Rhubarb Extract|"will receive rhubarb extract~rhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth"
10922136|NCT00672451|FG001|Participant Flow|Placebo|"receive placebo~placebo: placebo titrated up to 6 pills daily as patient tolerates"
10922137|NCT00672451|OG000|Outcome|Rhubarb Extract|"will receive rhubarb extract~rhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth"
10922138|NCT00672451|OG001|Outcome|Placebo|"receive placebo~placebo: placebo titrated up to 6 pills daily as patient tolerates"
10922139|NCT00672451|EG000|Reported Event|Rhubarb Extract|"will receive rhubarb extract~rhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth"
10922140|NCT00672451|EG001|Reported Event|Placebo|"receive placebo~placebo: placebo titrated up to 6 pills daily as patient tolerates"
10922141|NCT00672477|BG000|Baseline|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
10922142|NCT00672477|BG001|Baseline|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
10922143|NCT00672477|BG002|Baseline|Total|Total of all reporting groups
10922144|NCT00672477|FG000|Participant Flow|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
10922145|NCT00672477|FG001|Participant Flow|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
10922146|NCT00672477|OG000|Outcome|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
10922147|NCT00672477|OG001|Outcome|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
10922148|NCT00672477|EG000|Reported Event|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
10922149|NCT00672477|EG001|Reported Event|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
10922150|NCT00672490|BG000|Baseline|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
10922151|NCT00672490|BG001|Baseline|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
10922152|NCT00672490|BG002|Baseline|Total|Total of all reporting groups
10922153|NCT00672490|FG000|Participant Flow|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
10922154|NCT00672490|FG001|Participant Flow|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
10922155|NCT00672490|OG000|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
10922156|NCT00672490|OG001|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
10922157|NCT00672490|EG000|Reported Event|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
10922158|NCT00672490|EG001|Reported Event|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
10922159|NCT00672555|BG000|Baseline|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
10922160|NCT00672555|FG000|Participant Flow|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
10922161|NCT00672555|OG000|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
10922162|NCT00672555|EG000|Reported Event|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
10922163|NCT00672594|BG000|Baseline|Treatment|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
10922164|NCT00672594|FG000|Participant Flow|50mg Sunitinib Malate|Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
10922165|NCT00672594|OG000|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
10922166|NCT00672594|EG000|Reported Event|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
10963208|NCT00870870|BG002|Baseline|Gemcitabine/Cisplatin/Cetuximab (GCiC)|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963209|NCT00870870|BG003|Baseline|GCiC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycle).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963210|NCT00870870|BG004|Baseline|Total|Total of all reporting groups
10963211|NCT00870870|FG000|Participant Flow|Gemcitabine/Carboplatin/Cetuximab (GCC)|"Gemcitabine: 1000 milligrams per square meter (mg/m^2) on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 once every week (Q1W) of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 once every 2 weeks (Q2W) in the subsequent cycles (2-week cycles).~Carboplatin: Area under the curve (AUC) = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10964056|NCT00875641|BG000|Baseline|HRV Cohort|HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).
10922167|NCT00672620|BG000|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
10922168|NCT00672620|BG001|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
10922169|NCT00672620|BG002|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
10922170|NCT00672620|BG003|Baseline|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
10922171|NCT00672620|BG004|Baseline|Total|Total of all reporting groups
10922172|NCT00672620|FG000|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
10922173|NCT00672620|FG001|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
10922174|NCT00672620|FG002|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
10922175|NCT00672620|FG003|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period
10922176|NCT00672620|OG000|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
10922177|NCT00672620|OG001|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
10922178|NCT00672620|OG002|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
10922179|NCT00672620|OG003|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
10922180|NCT00672620|EG000|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
10922181|NCT00672620|EG001|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
11175179|NCT02027701|BG000|Baseline|IgPro20|20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg.
10922182|NCT00672620|EG002|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
10922183|NCT00672620|EG003|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
10922184|NCT00672633|BG000|Baseline|Lovaza|Treatment Arm
10922185|NCT00672633|BG001|Baseline|Placebo|Corn oil placebo
10922186|NCT00672633|BG002|Baseline|Total|Total of all reporting groups
10922187|NCT00672633|FG000|Participant Flow|Lovaza|Treatment Arm: 4 grams/day orally for 6 months
10922188|NCT00672633|FG001|Participant Flow|Placebo|Corn oil placebo: 4 pills/day orally for 6 months
10922189|NCT00672633|OG000|Outcome|Lovaza|Treatment Arm
11175180|NCT02027701|FG000|Participant Flow|IgPro20|20% liquid formulation (200 mg/mL) of human normal immunoglobulin administered SC weekly at 0.2 g/kg, and subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20.
11175181|NCT02027701|OG000|Outcome|IgPro20|20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
10922190|NCT00672633|OG001|Outcome|Placebo|Corn oil placebo
10922191|NCT00672633|EG000|Reported Event|Lovaza|Treatment Arm
10922192|NCT00672633|EG001|Reported Event|Placebo|Corn oil placebo
10922193|NCT00672646|BG000|Baseline|AZD1386|AZD1386 95 mg oral solution
10922194|NCT00672646|BG001|Baseline|Naproxen|Naproxen 500 mg capsule
10922195|NCT00672646|BG002|Baseline|Placebo|AZD1386 Placebo oral solution
10922196|NCT00672646|BG003|Baseline|Total|Total of all reporting groups
10922197|NCT00672646|FG000|Participant Flow|AZD1386|AZD1386 95 mg oral solution
10922198|NCT00672646|FG001|Participant Flow|Naproxen|Naproxen 500 mg capsule
10922199|NCT00672646|FG002|Participant Flow|Placebo|AZD1386 Placebo oral solution
10922200|NCT00672646|OG000|Outcome|AZD1386|AZD1386 95 mg oral solution
10922201|NCT00672646|OG001|Outcome|Naproxen|Naproxen 500 mg capsule
10922202|NCT00672646|OG002|Outcome|Placebo|AZD1386 Placebo oral solution
10922203|NCT00672646|EG000|Reported Event|AZD1386|AZD1386 95 mg oral solution
10922204|NCT00672646|EG001|Reported Event|Naproxen|Naproxen 500 mg capsule
10922205|NCT00672646|EG002|Reported Event|Placebo|AZD1386 Placebo oral solution
10922206|NCT00672737|BG000|Baseline|Male Volunteers at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
11175182|NCT02027701|OG000|Outcome|IgPro20|20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
11175183|NCT02027701|OG000|Outcome|IgPro20|20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg for up to 49 weeks.
11175184|NCT02027701|EG000|Reported Event|IgPro20|20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
10922207|NCT00672737|FG000|Participant Flow|Male Volunteers at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
10922208|NCT00672737|OG000|Outcome|at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
10922209|NCT00672737|OG000|Outcome|Males at Risk for OSA|"Males at risk for obstructive sleep apnea were invited to have a sleep study either at home or at Stanford Sleep Center.~A week after their sleep study (Polysomnography), all volunteers underwent quantitative sensory testing in the laboratory, during which their pain thresholds and tolerances to heat (Heat pain threshold and tolerance) and cold (Cold pain threshold and tolerance) stimuli were assessed, under two different concentrations (1 and 2 mcg/mL, in randomized order) of remifentanil, a short-acting opioid, given as a computer-controlled infusion.~Remifentanil: Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order."
10922210|NCT00672737|EG000|Reported Event|at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
10922211|NCT00672841|BG000|Baseline|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
10922212|NCT00672841|BG001|Baseline|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
10922213|NCT00672841|BG002|Baseline|Total|Total of all reporting groups
10922214|NCT00672841|FG000|Participant Flow|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
10922215|NCT00672841|FG001|Participant Flow|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy (i.e., intravenous anidulafungin 200mg on day one, then 100mg daily x 14 days) initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
10922216|NCT00672841|OG000|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
10922217|NCT00672841|OG001|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
10922218|NCT00672841|OG000|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
10922219|NCT00672841|OG001|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan (BDG) test for the presumptive early treatment of invasive candidiasis
10922220|NCT00672841|OG001|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
10922221|NCT00672841|EG000|Reported Event|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
10922222|NCT00672841|EG001|Reported Event|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
11175185|NCT02027844|BG000|Baseline|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
11175186|NCT02027844|BG001|Baseline|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
11175187|NCT02027844|BG002|Baseline|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
10922223|NCT00672854|BG000|Baseline|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
10922224|NCT00672854|BG001|Baseline|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
10922225|NCT00672854|BG002|Baseline|Total|Total of all reporting groups
10922226|NCT00672854|FG000|Participant Flow|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
10922227|NCT00672854|FG001|Participant Flow|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
11175188|NCT02027844|BG003|Baseline|Total|Total of all reporting groups
10922228|NCT00672854|OG000|Outcome|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"Total Parenteral Nutrition (TPN) subjects receive Intralipid 20% (soybean-based)~Intralipid: TPN with Intralipid (20%)"
10922229|NCT00672854|OG001|Outcome|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"Total Parenteral Nutrition (TPN) subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
10922230|NCT00672854|OG000|Outcome|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
10922231|NCT00672854|OG001|Outcome|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
10922232|NCT00672854|EG000|Reported Event|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)~Intralipid: TPN with Intralipid (20%)"
10922233|NCT00672854|EG001|Reported Event|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
10922234|NCT00672932|BG000|Baseline|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
10922235|NCT00672932|BG001|Baseline|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
10922236|NCT00672932|BG002|Baseline|Total|Total of all reporting groups
10922237|NCT00672932|FG000|Participant Flow|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
10922238|NCT00672932|FG001|Participant Flow|No Augmented Treatment Then Optional Rollover|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen. After 12 weeks, subjects in this group have the option to rollover into the raltegravir group for 12 weeks.
10922239|NCT00672932|OG000|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
10922240|NCT00672932|OG001|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
11357623|NCT03752151|BG000|Baseline|MARVEL 2 Monitor Mode Then MARVEL 2 Adaptive|Participants were programmed to MARVEL 2 algorithm monitor mode which provides standard VVI pacing for approximately 20 minutes. Then the MARVEL 2 algorithm was programmed to adaptive mode which provides VDD pacing for approximately 2 hours.
10922241|NCT00672932|EG000|Reported Event|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
10922242|NCT00672932|EG001|Reported Event|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
10922243|NCT00672958|BG000|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
10922244|NCT00672958|BG001|Baseline|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
10922245|NCT00672958|BG002|Baseline|Total|Total of all reporting groups
10922246|NCT00672958|FG000|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
10922247|NCT00672958|FG001|Participant Flow|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
10922248|NCT00672958|OG000|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
10922249|NCT00672958|OG001|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
10922250|NCT00672958|EG000|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
10922251|NCT00672958|EG001|Reported Event|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
10922252|NCT00672984|BG000|Baseline|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
10922253|NCT00672984|BG001|Baseline|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
10922254|NCT00672984|BG002|Baseline|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
10922255|NCT00672984|BG003|Baseline|Total|Total of all reporting groups
10922256|NCT00672984|FG000|Participant Flow|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
10922257|NCT00672984|FG001|Participant Flow|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
10922258|NCT00672984|FG002|Participant Flow|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
10922259|NCT00672984|OG000|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
10922260|NCT00672984|OG001|Outcome|Moxifloxacin|400 mg Avelox, positive control
10922261|NCT00672984|OG002|Outcome|Placebo (Guanfacine)|
10922262|NCT00672984|OG003|Outcome|Placebo (Moxifloxacin)|
10922263|NCT00672984|OG000|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
10922264|NCT00672984|EG000|Reported Event|Guanfacine|Immediate-release Guanfacine HCl
10922265|NCT00672984|EG001|Reported Event|Moxifloxacin|Avelox, positive control
10922266|NCT00672984|EG002|Reported Event|Placebo|
10922267|NCT00673049|BG000|Baseline|Figitumumab + Erlotinib (as Randomized)|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
10922268|NCT00673049|BG001|Baseline|Erlotinib (as Randomized)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
10922269|NCT00673049|BG002|Baseline|Total|Total of all reporting groups
10922270|NCT00673049|FG000|Participant Flow|Figitumumab + Erlotinib (Randomized to and Treated With)|Figitumumab ( [CP-751,871], figi) was given in combination with erlotinib (erlo) in 3-week cycles. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 milligram (mg) daily at least 1 hour before or 2 hours after the ingestion of food.
10922271|NCT00673049|FG001|Participant Flow|Erlotinib (Randomized to and Treated With)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
10922272|NCT00673049|FG002|Participant Flow|Randomized to Figi + Erlo Arm But Treated Only With Erlo|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
10922273|NCT00673049|FG003|Participant Flow|Erlotinib, Then Figitumumab|Figitumumab 20 mg/kg was given as a single-agent therapy to participants who had disease progression on erlotinib alone. Figitumumab was administered in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
10922274|NCT00673049|OG000|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
10922275|NCT00673049|OG001|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
10922276|NCT00673049|OG000|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
10922277|NCT00673049|EG000|Reported Event|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycle. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every three weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
10922278|NCT00673049|EG001|Reported Event|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
10922279|NCT00673049|EG002|Reported Event|Erlotinib, Then Figitumumab|Figitumumab (20 mg/kg) was given as a single agent after participants had disease progression on erlotinib alone. Figitumumab was given in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
10922280|NCT00673075|BG000|Baseline|Nebivolol|Encapsulated Nebivolol
10922281|NCT00673075|BG001|Baseline|Carvedilol|Encapsulated Carvedilol
10922282|NCT00673075|BG002|Baseline|Total|Total of all reporting groups
10922283|NCT00673075|FG000|Participant Flow|Nebivolol|Encapsulated Nebivolol
10922284|NCT00673075|FG001|Participant Flow|Carvedilol|Encapsulated Carvedilol
10922285|NCT00673075|OG000|Outcome|Nebivolol|Encapsulated Nebivolol
10922286|NCT00673075|OG001|Outcome|Carvedilol|Encapsulated Carvedilol
10922287|NCT00673075|EG000|Reported Event|Nebivolol Combined Up-Titration and Stable-dose|Encapsulated Nebivolol Combined Up-Titration and Stable-Dose Periods
10922288|NCT00673075|EG001|Reported Event|Carvedilol Combined Up-Titration and Stable-dose|Encapsulated Carvedilol Combined Up-Titration and Stable-Dose Periods
10922289|NCT00673075|EG002|Reported Event|Nebivolol Down-Titration|Encapsulated Nebivolol Down-Titration Period
10922290|NCT00673075|EG003|Reported Event|Carvedilol Down-Titration|Encapsulated Carvedilol Down-Titration Period
10922291|NCT00673114|BG000|Baseline|Transplant Recipients|single arm study
10922292|NCT00673114|FG000|Participant Flow|Transplant Recipients|Transplant Recipients
10922293|NCT00673114|OG000|Outcome|Transplant Recipients|single arm study
10922294|NCT00673114|EG000|Reported Event|Transplant Recipients|single arm study
10922295|NCT00673127|BG000|Baseline|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
10922296|NCT00673127|FG000|Participant Flow|KHAD|KHAD; ketoconazole, hydrocortisone and dutasteride for CRPC
10922297|NCT00673127|OG000|Outcome|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
10922298|NCT00673127|OG000|Outcome|KHAD|KHAD: ketoconazole, hydrocortisone and dutasteride for CRPC
10922299|NCT00673127|EG000|Reported Event|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
10922300|NCT00673153|BG000|Baseline|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
11175189|NCT02027844|FG000|Participant Flow|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
11175190|NCT02027844|FG001|Participant Flow|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
11175191|NCT02027844|FG002|Participant Flow|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
10922301|NCT00673153|FG000|Participant Flow|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
10922302|NCT00673153|OG000|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
10922303|NCT00673153|EG000|Reported Event|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
10922304|NCT00673231|BG000|Baseline|Placebo|Placebo
10922305|NCT00673231|BG001|Baseline|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
10922306|NCT00673231|BG002|Baseline|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
10922307|NCT00673231|BG003|Baseline|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
10922308|NCT00673231|BG004|Baseline|Total|Total of all reporting groups
10922309|NCT00673231|FG000|Participant Flow|Placebo|Placebo
10922310|NCT00673231|FG001|Participant Flow|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
10922311|NCT00673231|FG002|Participant Flow|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
10922312|NCT00673231|FG003|Participant Flow|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
10922313|NCT00673231|OG000|Outcome|Placebo|Placebo
10922314|NCT00673231|OG001|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
10922315|NCT00673231|OG002|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
10922316|NCT00673231|OG003|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
10922317|NCT00673231|EG000|Reported Event|Placebo|Placebo
10922318|NCT00673231|EG001|Reported Event|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
10922319|NCT00673231|EG002|Reported Event|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
10922320|NCT00673231|EG003|Reported Event|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
10922321|NCT00673244|BG000|Baseline|Did Not Progress to AKIN Stage III|Subject did not require RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of FST.
11175192|NCT02027844|OG000|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
11175193|NCT02027844|OG001|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
11175194|NCT02027844|OG002|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
10922322|NCT00673244|BG001|Baseline|Progressed to AKIN Stage III|Subject required RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of FST.
10922323|NCT00673244|BG002|Baseline|Total|Total of all reporting groups
10922324|NCT00673244|FG000|Participant Flow|Did Not Progress to AKIN Stage III|Did not meet the following criteria within 14 days of furosemide stress test (FST): Need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours
10922325|NCT00673244|FG001|Participant Flow|Progressed to AKIN Stage III|Meet the following criteria within 14 days of Furosemide stress test (FST): need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours
10922326|NCT00673244|OG000|Outcome|Progressed to AKIN Stage III|Need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test.
10922327|NCT00673244|OG001|Outcome|Did Not Progress to AKIN Stage-III|Did not need RRT, have increase in serum creatinine of 300% over baseline, or have urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test.
10922328|NCT00673244|EG000|Reported Event|Progressed to AKIN III|RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test
10922329|NCT00673244|EG001|Reported Event|Did Not Progress to AKIN III|No RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test
10922330|NCT00673257|BG000|Baseline|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
10922331|NCT00673257|FG000|Participant Flow|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
10922332|NCT00673257|OG000|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
10922333|NCT00673257|EG000|Reported Event|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
10922334|NCT00673387|BG000|Baseline|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
10922335|NCT00673387|BG001|Baseline|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922336|NCT00673387|BG002|Baseline|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
10922337|NCT00673387|BG003|Baseline|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
10922338|NCT00673387|BG004|Baseline|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
11175195|NCT02027844|EG000|Reported Event|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
11175196|NCT02027844|EG001|Reported Event|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
11175197|NCT02027844|EG002|Reported Event|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
10922339|NCT00673387|BG005|Baseline|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922340|NCT00673387|BG006|Baseline|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922341|NCT00673387|BG007|Baseline|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922342|NCT00673387|BG008|Baseline|Total|Total of all reporting groups
10922343|NCT00673387|FG000|Participant Flow|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
10922344|NCT00673387|FG001|Participant Flow|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922345|NCT00673387|FG002|Participant Flow|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
10922346|NCT00673387|FG003|Participant Flow|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
10922347|NCT00673387|FG004|Participant Flow|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
10922348|NCT00673387|FG005|Participant Flow|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922349|NCT00673387|FG006|Participant Flow|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922350|NCT00673387|FG007|Participant Flow|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922351|NCT00673387|OG000|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
10922352|NCT00673387|OG001|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922353|NCT00673387|OG002|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
10922354|NCT00673387|OG003|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
11175198|NCT02027883|BG000|Baseline|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
10922355|NCT00673387|OG004|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
10922356|NCT00673387|OG005|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922357|NCT00673387|OG006|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922358|NCT00673387|OG007|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922359|NCT00673387|OG000|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
10922360|NCT00673387|OG001|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
10922361|NCT00673387|OG002|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
11175199|NCT02027883|BG001|Baseline|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
11175200|NCT02027883|BG002|Baseline|Total|Total of all reporting groups
11175201|NCT02027883|FG000|Participant Flow|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
11175202|NCT02027883|FG001|Participant Flow|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
11175203|NCT02027883|OG000|Outcome|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
11175204|NCT02027883|OG001|Outcome|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
10922362|NCT00673387|OG003|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922363|NCT00673387|OG004|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922364|NCT00673387|OG005|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922365|NCT00673387|OG004|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
10922366|NCT00673387|OG000|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922367|NCT00673387|OG002|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
10922368|NCT00673387|OG000|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
10922369|NCT00673387|EG000|Reported Event|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
10922370|NCT00673387|EG001|Reported Event|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
11175205|NCT02027883|OG000|Outcome|Nominal Parameter|Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust.
10922371|NCT00673387|EG002|Reported Event|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
10922372|NCT00673387|EG003|Reported Event|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
10922373|NCT00673387|EG004|Reported Event|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
10922374|NCT00673387|EG005|Reported Event|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922375|NCT00673387|EG006|Reported Event|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922376|NCT00673387|EG007|Reported Event|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
10922377|NCT00673400|BG000|Baseline|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
10922378|NCT00673400|FG000|Participant Flow|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
10922379|NCT00673400|OG000|Outcome|Before Surgery|outcome measured within one month before surgery
10922380|NCT00673400|OG001|Outcome|6 Months After Surgery|outcome measured within one month before surgery
10922381|NCT00673400|OG000|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
10922382|NCT00673400|OG001|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
10922383|NCT00673400|OG002|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
10922384|NCT00673400|OG003|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
10922385|NCT00673400|OG001|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
10922386|NCT00673400|EG000|Reported Event|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
10922387|NCT00673439|BG000|Baseline|Fondaparinux|daily subcutaneous injection of fondaparinux (7.5-10 mg)
10922388|NCT00673439|FG000|Participant Flow|Fondaparinux|daily subcutaneous injection of fondaparinux (7.5-10 mg)
10922389|NCT00673439|OG000|Outcome|Fondaparinux|daily subcutaneous injection of fondaparinux (7.5-10 mg)
10922390|NCT00673439|OG000|Outcome|Fondaparinux|"daily subcutaneous injection of fondaparinux (7.5-10 mg)~fondaparinux: Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2~warfarin: Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks"
10922391|NCT00673439|EG000|Reported Event|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
10922392|NCT00673452|BG000|Baseline|Duloxetine|60-120 mg, oral, daily, 12 weeks
10922393|NCT00673452|BG001|Baseline|Placebo|oral, daily, 12 weeks
10922394|NCT00673452|BG002|Baseline|Total|Total of all reporting groups
10922395|NCT00673452|FG000|Participant Flow|Duloxetine|60-120 mg, oral, daily, 12 weeks
11175206|NCT02027883|OG001|Outcome|Experimental Parameter|Educated T shock setting: Experimental Parameter Set 2 Programming Values.
11357624|NCT03752151|FG000|Participant Flow|MARVEL 2 Monitor Mode Then MARVEL 2 Adaptive Mode|Participants were programmed to MARVEL 2 algorithm monitor mode which provides standard VVI pacing for approximately 20 minutes. Then the MARVEL 2 algorithm was programmed to adaptive mode which provides VDD pacing for approximately 2 hours.
10922396|NCT00673452|FG001|Participant Flow|Placebo|oral, daily, 12 weeks
10922397|NCT00673452|OG000|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
10922398|NCT00673452|OG001|Outcome|Placebo|oral, daily, 12 weeks
10922399|NCT00673452|EG000|Reported Event|Duloxetine|60-120 mg, oral, daily, 12 weeks
10922400|NCT00673452|EG001|Reported Event|Placebo|oral, daily, 12 weeks
10922401|NCT00673465|BG000|Baseline|All Treated Participants|All participants received SCH 497079 for 4 weeks, placebo for 4 weeks, and metformin for 4 weeks during one of three parts of the study.
10922402|NCT00673465|FG000|Participant Flow|Part 1/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
10922403|NCT00673465|FG001|Participant Flow|Part 1/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2)followed by SCH 497079 daily for 4 weeks (Period 3).
10922404|NCT00673465|FG002|Participant Flow|Part 1/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2)followed by placebo daily for 4 weeks (Period 3).
10922405|NCT00673465|FG003|Participant Flow|Part 1/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
10922406|NCT00673465|FG004|Participant Flow|Part 1/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
10922407|NCT00673465|FG005|Participant Flow|Part 1/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
10922408|NCT00673465|FG006|Participant Flow|Part 2/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
10922409|NCT00673465|FG007|Participant Flow|Part 2/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
10922410|NCT00673465|FG008|Participant Flow|Part 2/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
10922411|NCT00673465|FG009|Participant Flow|Part 2/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
10922412|NCT00673465|FG010|Participant Flow|Part 2/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
10922413|NCT00673465|FG011|Participant Flow|Part 2/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks(Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
10922414|NCT00673465|OG000|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
10922415|NCT00673465|OG001|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
10922416|NCT00673465|OG002|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
10922417|NCT00673465|EG000|Reported Event|Placebo|Participants received placebo daily for 4 weeks during one of 3 parts of the study.
10922418|NCT00673465|EG001|Reported Event|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
10922419|NCT00673465|EG002|Reported Event|Metformin|Participants received metformin daily for 4 weeks during one of 3 parts of the study.
10922420|NCT00673660|BG000|Baseline|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922421|NCT00673660|FG000|Participant Flow|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922422|NCT00673660|OG000|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922423|NCT00673660|OG000|Outcome|Compliant With Statin Treatment|Participants with dyslipidemia who were compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922424|NCT00673660|OG001|Outcome|Non-compliant With Statin Treatment|Participants with dyslipidemia who were non-compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922425|NCT00673660|EG000|Reported Event|Statins at Visit 2|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922426|NCT00673660|EG001|Reported Event|Statins at Visit 3|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922427|NCT00673660|EG002|Reported Event|Statins at Visit 4|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922428|NCT00673660|EG003|Reported Event|Statins Visit 5|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
10922429|NCT00673673|BG000|Baseline|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
10922430|NCT00673673|FG000|Participant Flow|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
10922431|NCT00673673|OG000|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
10922432|NCT00673673|EG000|Reported Event|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
10922433|NCT00673712|BG000|Baseline|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
10922434|NCT00673712|BG001|Baseline|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
10922435|NCT00673712|BG002|Baseline|Total|Total of all reporting groups
10922436|NCT00673712|FG000|Participant Flow|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
11175207|NCT02027883|OG000|Outcome|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust~The standard T-Shock method was successful in 76% of the patients. 38 out of 50 patients Ventricular Fibrillation was induced with the nominal T shock method. In contrast, 87 % or 13 out of 15 that failed to induce Ventricular Fibrillation using the educated T-Shock method was successfully induced when crossed to the nominal T-shock method."
10922437|NCT00673712|FG001|Participant Flow|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
10922438|NCT00673712|OG000|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
10922439|NCT00673712|OG001|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
10922440|NCT00673712|EG000|Reported Event|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
11191945|NCT02135445|FG000|Participant Flow|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
10922441|NCT00673712|EG001|Reported Event|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
10922442|NCT00673738|BG000|Baseline|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
10922443|NCT00673738|FG000|Participant Flow|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
10922444|NCT00673738|OG000|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
10922445|NCT00673738|EG000|Reported Event|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
10922446|NCT00673764|BG000|Baseline|Overall Study|Overall Study
10922447|NCT00673764|FG000|Participant Flow|Systane Ultra, Then Optive|Systane Ultra Lubricant Eye Drops first, then cross-over to Optive.
10922448|NCT00673764|FG001|Participant Flow|Optive, Then Systane Ultra|Optive Lubricant Eye Drops first, then cross-over to Systane Ultra.
10922449|NCT00673764|OG000|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
10922450|NCT00673764|OG001|Outcome|Optive|Optive Lubricant Eye Drops
10922451|NCT00673764|EG000|Reported Event|Systane Ultra|Systane Ultra Lubricant Eye Drops.
10922452|NCT00673764|EG001|Reported Event|Optive|Optive Lubricant Eye Drops
10922453|NCT00673790|BG000|Baseline|Nebivolol|Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
10922454|NCT00673790|BG001|Baseline|Hydrochlorothiazide (HCTZ)|Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922455|NCT00673790|BG002|Baseline|Placebo|Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922456|NCT00673790|BG003|Baseline|Total|Total of all reporting groups
10922457|NCT00673790|FG000|Participant Flow|Nebivolol|Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
10922458|NCT00673790|FG001|Participant Flow|Hydrochlorothiazide (HCTZ)|Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922459|NCT00673790|FG002|Participant Flow|Placebo|Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922460|NCT00673790|OG000|Outcome|Nebivolol|Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
10922461|NCT00673790|OG001|Outcome|Placebo|Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922462|NCT00673790|OG001|Outcome|Hydrochlorothiazide (HCTZ)|Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922463|NCT00673790|OG002|Outcome|Placebo|Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922464|NCT00673790|EG000|Reported Event|Nebivolol|Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
11175208|NCT02027883|OG001|Outcome|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values~The educated T shock setting method was successful in 70% of the patients. 35 out of 50 patients Ventricular Fibrillation was induced with the educated T- shock method. Of the 12 patients that were did not have Ventricular fibrillation induced with the nominal T-shock method, they were all successfully induced with the educated T-Shock method."
11175209|NCT02027883|EG000|Reported Event|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
11175210|NCT02027883|EG001|Reported Event|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
11175211|NCT02028065|BG000|Baseline|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
11175212|NCT02028065|BG001|Baseline|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
10922465|NCT00673790|EG001|Reported Event|Hydrochlorothiazide (HCTZ)|Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922466|NCT00673790|EG002|Reported Event|Placebo|Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
10922467|NCT00673816|BG000|Baseline|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
10922468|NCT00673816|FG000|Participant Flow|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
10922469|NCT00673816|OG000|Outcome|Left Eye|
10922470|NCT00673816|OG001|Outcome|Right Eye|
10922471|NCT00673816|EG000|Reported Event|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
10922472|NCT00673855|BG000|Baseline|Overall Study|
10922473|NCT00673855|FG000|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received lubricant Drops first, then received Optive Drops
10922474|NCT00673855|FG001|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
10922475|NCT00673855|OG000|Outcome|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
10922476|NCT00673855|OG001|Outcome|Lubricant Eye Drops|Lubricant Eye Drops
10922477|NCT00673855|EG000|Reported Event|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
10922478|NCT00673855|EG001|Reported Event|Lubricant Eye Drops|Lubricant Eye Drops
10922479|NCT00673881|BG000|Baseline|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
10922480|NCT00673881|FG000|Participant Flow|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
10922481|NCT00673881|OG000|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
10922482|NCT00673881|EG000|Reported Event|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
10922483|NCT00673894|BG000|Baseline|First Received Sitagliptin, Then Placebo|Participants first received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks
10922484|NCT00673894|BG001|Baseline|First Received Placebo, Then Sitagliptin|Participants first received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d +Sitagliptin (100 mg) for 4 weeks
10922485|NCT00673894|BG002|Baseline|Total|Total of all reporting groups
11175213|NCT02028065|BG002|Baseline|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
11175214|NCT02028065|BG003|Baseline|Total|Total of all reporting groups
10922486|NCT00673894|FG000|Participant Flow|Sitagliptin, Then Placebo|Participants first received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks
10922487|NCT00673894|FG001|Participant Flow|Placebo, Then Sitagliptin|Participants first received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks
10922488|NCT00673894|OG000|Outcome|Glutamine+Sitagliptin|"Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin~Sitagliptin: Glutamine 30g +sitagliptin 100mg"
10922489|NCT00673894|OG001|Outcome|Glutamine+Placebo|"Glutamine 30 g/d (15 g with breakfast and dinner) + placebo~Placebo: Glutamine 30g +placebo"
10922490|NCT00673894|EG000|Reported Event|Sitagliptin|Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin
10922491|NCT00673894|EG001|Reported Event|Placebo|Glutamine 30 g/d (15 g with breakfast and dinner) + Placebo
10922492|NCT00673920|BG000|Baseline|Placebo|"Participants received matching placebo:~on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)~on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)"
10922493|NCT00673920|BG001|Baseline|Ocrelizumab 400mg|Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
10922494|NCT00673920|BG002|Baseline|Ocrelizumab 200mg|Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
10922495|NCT00673920|BG003|Baseline|Ocrelizumab 200mg/ Ocrelizumab 200mg|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
10922496|NCT00673920|BG004|Baseline|Ocrelizumab 200mg/ Ocrelizumab 400mg|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922497|NCT00673920|BG005|Baseline|Ocrelizumab 400mg/ Ocrelizumab 400mg|Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922498|NCT00673920|BG006|Baseline|Placebo/ Ocrelizumab 200mg|Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
10922499|NCT00673920|BG007|Baseline|Placebo/ Ocrelizumab 400mg|Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922500|NCT00673920|BG008|Baseline|Total|Total of all reporting groups
11175215|NCT02028065|FG000|Participant Flow|Placebo|Administration of 3 single intravenous (IV) doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
11175216|NCT02028065|FG001|Participant Flow|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
11175217|NCT02028065|FG002|Participant Flow|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
11175218|NCT02028065|OG000|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
11175219|NCT02028065|OG001|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
10922501|NCT00673920|FG000|Participant Flow|Placebo|"Participants received matching placebo:~on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)~on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)"
10922502|NCT00673920|FG001|Participant Flow|Ocrelizumab 400mg|Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
10922503|NCT00673920|FG002|Participant Flow|Ocrelizumab 200mg|Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
10922504|NCT00673920|FG003|Participant Flow|Ocrelizumab 200mg/ Ocrelizumab 200mg|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
10922505|NCT00673920|FG004|Participant Flow|Ocrelizumab 200mg/ Ocrelizumab 400mg|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922506|NCT00673920|FG005|Participant Flow|Ocrelizumab 400mg/ Ocrelizumab 400mg|Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922507|NCT00673920|FG006|Participant Flow|Placebo/ Ocrelizumab 200mg|Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
10922508|NCT00673920|FG007|Participant Flow|Placebo/ Ocrelizumab 400mg|Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922509|NCT00673920|OG000|Outcome|Placebo|"Participants received matching placebo:~on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)~on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)"
10922510|NCT00673920|OG001|Outcome|Ocrelizumab 400mg|Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
10922511|NCT00673920|OG002|Outcome|Ocrelizumab 200mg - Cycle 1|Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
10922512|NCT00673920|OG003|Outcome|Ocrelizumab 200mg/ Ocrelizumab 200mg|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
10922513|NCT00673920|OG004|Outcome|Ocrelizumab 200mg/ Ocrelizumab 400mg|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922514|NCT00673920|OG005|Outcome|Ocrelizumab 400mg/ Ocrelizumab 400mg|Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922515|NCT00673920|OG006|Outcome|Placebo/ Ocrelizumab 200mg|Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
10922516|NCT00673920|OG007|Outcome|Placebo/ Ocrelizumab 400mg|Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922517|NCT00673920|OG000|Outcome|Ocrelizumab 200mg - Cycle 1|Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
10922518|NCT00673920|OG001|Outcome|Ocrelizumab 200mg - Cycle 2|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate in Cycle 2
10922519|NCT00673920|OG002|Outcome|Ocrelizumab 400mg - Cycle 1|Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
10922520|NCT00673920|OG003|Outcome|Ocrelizumab 400mg - Cycle 2|Participants who received a single infusion of 400 mg Ocrelizumab + Methotraxate in Cycle 2
10922521|NCT00673920|EG000|Reported Event|Placebo|"Participants received matching placebo:~on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)~on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)"
11175220|NCT02028065|OG002|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
10922522|NCT00673920|EG001|Reported Event|Ocrelizumab 400mg|Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
10922523|NCT00673920|EG002|Reported Event|Ocrelizumab 200mg|Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
10922524|NCT00673920|EG003|Reported Event|Ocrelizumab 200mg/ Ocrelizumab 200mg|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
10922525|NCT00673920|EG004|Reported Event|Ocrelizumab 200mg/ Ocrelizumab 400mg|Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922526|NCT00673920|EG005|Reported Event|Ocrelizumab 400mg/ Ocrelizumab 400mg|Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922527|NCT00673920|EG006|Reported Event|Placebo/ Ocrelizumab 200mg|Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
10922528|NCT00673920|EG007|Reported Event|Placebo/ Ocrelizumab 400mg|Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
10922529|NCT00673933|BG000|Baseline|Visonac and Vehicle Cream With PDT|Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.
10922530|NCT00673933|FG000|Participant Flow|Visonac Cream With PDT and Vehicle and PDT|Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
10922531|NCT00673933|OG000|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
10922532|NCT00673933|OG001|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
10922533|NCT00673933|EG000|Reported Event|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
10922534|NCT00673933|EG001|Reported Event|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
10922535|NCT00673959|BG000|Baseline|Overall Study|
10922536|NCT00673959|FG000|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received Lubricant Drops first, then received Optive Drops
11175221|NCT02028065|EG000|Reported Event|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
10922537|NCT00673959|FG001|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
10922538|NCT00673959|OG000|Outcome|Lubricant Eye Drop FID 111421|
10922539|NCT00673959|OG001|Outcome|Optive Lubricant Eye Drop|
10922540|NCT00673959|EG000|Reported Event|Lubricant Eye Drop FID 111421|
10922541|NCT00673959|EG001|Reported Event|Optive Lubricant Eye Drop|
10922542|NCT00674115|BG000|Baseline|Entire Study Population|
10922543|NCT00674115|FG000|Participant Flow|Zegerid, Prilosec, Sodium Bicarbonate|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention, Prilosec over-the-counter (OTC) Tablets (omeprazole 20 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
10922544|NCT00674115|FG001|Participant Flow|Prilosec, Zegerid, Sodium Bicarbonate|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention, Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
11175222|NCT02028065|EG001|Reported Event|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
11175223|NCT02028065|EG002|Reported Event|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
10922545|NCT00674115|FG002|Participant Flow|Zegerid, Prilosec|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
10922546|NCT00674115|FG003|Participant Flow|Prilosec, Zegerid|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period)
10922547|NCT00674115|OG000|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
10922548|NCT00674115|OG001|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
10922549|NCT00674115|EG000|Reported Event|Zegerid (7-Day Dosing)|
10922550|NCT00674115|EG001|Reported Event|Prilosec (7-Day Dosing)|
10922551|NCT00674115|EG002|Reported Event|Sodium Bicarbonate (1-Day Dosing)|Following completion of the 1-day dosing 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate 1680 mg.
10922552|NCT00674115|EG003|Reported Event|Zegerid (1-Day Dosing)|
10922553|NCT00674115|EG004|Reported Event|Prilosec (1-Day Dosing)|
10922554|NCT00674128|BG000|Baseline|Adhesive|Cyanoacrylate tissue adhesive.
11175224|NCT02028169|BG000|Baseline|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
11175225|NCT02028169|FG000|Participant Flow|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed psoriatic arthritis (PsA) for which the physician has initiated treatment with an anti-tumor necrosis factor (TNF).
10922555|NCT00674128|BG001|Baseline|Suture|Polyglactin 910 suture.
10922556|NCT00674128|BG002|Baseline|Total|Total of all reporting groups
10922557|NCT00674128|FG000|Participant Flow|Adhesive|Cyanoacrylate tissue adhesive.
10922558|NCT00674128|FG001|Participant Flow|Suture|Polyglactin 910 suture.
10922559|NCT00674128|OG000|Outcome|Adhesive|Cyanoacrylate tissue adhesive.
10922560|NCT00674128|OG001|Outcome|Suture|Polyglactin 910 suture.
11175226|NCT02028169|OG000|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
10922561|NCT00674128|EG000|Reported Event|Adhesive|Cyanoacrylate tissue adhesive.
10922562|NCT00674128|EG001|Reported Event|Suture|Polyglactin 910 suture
10922563|NCT00674154|BG000|Baseline|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
10922564|NCT00674154|BG001|Baseline|Placebo|Placebo, two tablets daily in 52 weeks.
10922565|NCT00674154|BG002|Baseline|Total|Total of all reporting groups
10922566|NCT00674154|FG000|Participant Flow|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
10922567|NCT00674154|FG001|Participant Flow|Placebo|Placebo, two tablets daily in 52 weeks.
10922568|NCT00674154|OG000|Outcome|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
10922569|NCT00674154|OG001|Outcome|Placebo|Placebo, two tablets daily in 52 weeks.
10922570|NCT00674154|EG000|Reported Event|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
10922571|NCT00674154|EG001|Reported Event|Placebo|Placebo, two tablets daily in 52 weeks.
10922572|NCT00674206|BG000|Baseline|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
10922573|NCT00674206|FG000|Participant Flow|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
10922574|NCT00674206|OG000|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
10922575|NCT00674206|EG000|Reported Event|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
10922576|NCT00674219|BG000|Baseline|OCD Group|Persons meeting inclusion criteria for a diagnosis of obsessive-compulsive disorder
10922577|NCT00674219|BG001|Baseline|GAD Group|Persons meeting inclusion criteria for a diagnosis of generalized anxiety disorder
10922578|NCT00674219|BG002|Baseline|Total|Total of all reporting groups
10922579|NCT00674219|FG000|Participant Flow|OCD Group|Persons meeting inclusion criteria for a diagnosis of obsessive-compulsive disorder.
10922580|NCT00674219|FG001|Participant Flow|GAD Group|Persons meeting inclusion criteria for a diagnosis of generalized anxiety disorder.
10922581|NCT00674219|OG000|Outcome|OCD Group|Persons meeting inclusion criteria for a diagnosis of OCD.
10922582|NCT00674219|OG001|Outcome|GAD Group|Persons meeting inclusion criteria for a diagnosis of GAD.
10922583|NCT00674219|EG000|Reported Event|OCD Group|"OCD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication.~Memantine: Namenda 10mg BID for 12 weeks"
10922584|NCT00674219|EG001|Reported Event|GAD Group|"GAD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication.~Memantine: Namenda 10mg BID for 12 weeks"
10922585|NCT00674297|BG000|Baseline|Fluvastatin|"All patients will take Fluvastatin 40 mg daily for 3 months.~Fluvastatin: Fluvastatin 40 mg daily for 3 months"
10922586|NCT00674297|FG000|Participant Flow|PAPS|Primary APS
10922587|NCT00674297|FG001|Participant Flow|SLE/APS|SLE with APS
10922588|NCT00674297|FG002|Participant Flow|Primary aPL|Persistant aPL positivity without SLE or APS.
10922589|NCT00674297|FG003|Participant Flow|SLE/aPL|Persistent aPL positivity with SLE but no APS.
10922590|NCT00674297|OG000|Outcome|PAPS|Primary APS
10922591|NCT00674297|OG001|Outcome|SLE/APS|SLE with APS
10922592|NCT00674297|OG002|Outcome|Primary aPL|Persistant aPL positivity without SLE or APS.
10922593|NCT00674297|OG003|Outcome|SLE/aPL|Persistent aPL positivity with SLE but no APS.
10922594|NCT00674297|EG000|Reported Event|aPL Positive Patients|Patients with aPL positivity
10922595|NCT00674323|BG000|Baseline|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922596|NCT00674323|BG001|Baseline|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922597|NCT00674323|BG002|Baseline|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922598|NCT00674323|BG003|Baseline|Total|Total of all reporting groups
10922599|NCT00674323|FG000|Participant Flow|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922600|NCT00674323|FG001|Participant Flow|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922601|NCT00674323|FG002|Participant Flow|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922602|NCT00674323|OG000|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922603|NCT00674323|OG001|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922604|NCT00674323|OG002|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
10922605|NCT00674323|EG000|Reported Event|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
11175227|NCT02028169|EG000|Reported Event|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
11175228|NCT02028182|BG000|Baseline|Positive Reactions, Concordance With Reference Allergen|"Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and a negative control. A second panel containing 20 mg of 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application.~Allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and negative control"
11175229|NCT02028182|FG000|Participant Flow|Positive Reactions, Concordance With Reference Allergen|"Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application.~Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control"
11175230|NCT02028182|OG000|Outcome|Positive Reactions, Concordance With Reference Allergen|"Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application.~Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control"
11175231|NCT02028182|OG000|Outcome|Positive Reactions, Concordance With Reference Allergen|"Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and a negative control. A second panel containing 20 mg of 5% Lyral in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application.~Lyral®: Alergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control"
11175232|NCT02028182|EG000|Reported Event|Positive Reactions, Concordance With Reference Allergen|Subjects were patch tested with an experimental allergen panel containing all doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. It is not possible to discern specific dose relative to adverse events.
11175233|NCT02028208|BG000|Baseline|Ammoniated Mercury|"Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.~Ammoniated mercury: Metal allergen panel containing ascending doses of ammoniated mercury and a negative control."
10964057|NCT00875641|BG001|Baseline|Concurrent Control Cohort|Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).
11175234|NCT02028208|BG001|Baseline|Aluminum Chloride and Aluminum Lactate|"Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.~Aluminum chloride and aluminum lactate: Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control."
10922606|NCT00674323|EG001|Reported Event|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
10922607|NCT00674323|EG002|Reported Event|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
10922608|NCT00674362|BG000|Baseline|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
10922609|NCT00674362|BG001|Baseline|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
10922610|NCT00674362|BG002|Baseline|Total|Total of all reporting groups
10922611|NCT00674362|FG000|Participant Flow|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
10922612|NCT00674362|FG001|Participant Flow|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
10922613|NCT00674362|OG000|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
10922614|NCT00674362|OG001|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
10922615|NCT00674362|EG000|Reported Event|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
10922616|NCT00674362|EG001|Reported Event|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
10922617|NCT00674362|EG002|Reported Event|Open Label Phase|At Week 24 subjects are evaluated. Non-remitters are discontinued from the study with the opportunity to enter another open label (OL) study. Remitters stop randomized treatment and are followed up until Week 52. Remitters who flare up between Week 24 and Week 52 will be re-treated with (3 administrations of 400 mg CZP, given every other week, followed by 200 mg CZP given every other week) up to and including Week 50. Of the 27 subjects in the OL phase 15 were retreated and 12 were not retreated.
10922618|NCT00674466|BG000|Baseline|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
10922619|NCT00674466|BG001|Baseline|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
11191946|NCT02135445|FG001|Participant Flow|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
10922620|NCT00674466|BG002|Baseline|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
10922621|NCT00674466|BG003|Baseline|Total|Total of all reporting groups
10922622|NCT00674466|FG000|Participant Flow|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
10922623|NCT00674466|FG001|Participant Flow|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
10922624|NCT00674466|FG002|Participant Flow|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
10922625|NCT00674466|OG000|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
10922626|NCT00674466|OG001|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
10922627|NCT00674466|OG002|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
10922628|NCT00674466|EG000|Reported Event|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
10922629|NCT00674466|EG001|Reported Event|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
10922630|NCT00674466|EG002|Reported Event|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
10922631|NCT00674479|BG000|Baseline|INCB018424|"The starting dose of INCB018424 will be 25 mg by mouth twice daily.~INCB018424: Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks."
10922632|NCT00674479|FG000|Participant Flow|INCB018424|"The starting dose of INCB018424 will be 25 mg by mouth twice daily.~INCB018424: Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks."
10922633|NCT00674479|OG000|Outcome|INCB018424|"The starting dose of INCB018424 will be 25 mg by mouth twice daily.~INCB018424: Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks."
10922634|NCT00674479|EG000|Reported Event|INCB018424|"The starting dose of INCB018424 will be 25 mg by mouth twice daily.~INCB018424: Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks."
10922635|NCT00674492|BG000|Baseline|Group 1|patients who initiated antiviral treatment for hepatitis C
10922636|NCT00674492|FG000|Participant Flow|Group 1|patients who initiated antiviral treatment for hepatitis C
10922637|NCT00674492|OG000|Outcome|Group 1|patients who initiated antiviral treatment for hepatitis C
10922638|NCT00674492|EG000|Reported Event|Group 1|patients who initiated antiviral treatment for hepatitis C
10922639|NCT00674570|BG000|Baseline|Arm 1: Hydrocortisone|"Hydrocortisone~Hydrocortisone: 25 mg/oral one hour prior to extinction task"
10922640|NCT00674570|BG001|Baseline|Arm 2: D-Cycloserine|"D-Cycloserine~D-Cycloserine: 50 mg/oral one hour prior to extinction task"
10922641|NCT00674570|BG002|Baseline|Arm 3: Placebo|"Placebo~Placebo: One hour prior to extinction task"
10922642|NCT00674570|BG003|Baseline|Total|Total of all reporting groups
10922643|NCT00674570|FG000|Participant Flow|Arm 1: Hydrocortisone|"Hydrocortisone~Hydrocortisone: 25 mg/oral one hour prior to extinction task"
10922644|NCT00674570|FG001|Participant Flow|Arm 2: D-Cycloserine|"D-Cycloserine~D-Cycloserine: 50 mg/oral one hour prior to extinction task"
10922645|NCT00674570|FG002|Participant Flow|Arm 3: Placebo|"Placebo~Placebo: One hour prior to extinction task"
10922646|NCT00674570|OG000|Outcome|Arm 1: Hydrocortisone|"Hydrocortisone~Hydrocortisone: 25 mg/oral one hour prior to extinction task"
10922647|NCT00674570|OG001|Outcome|Arm 2: D-Cycloserine|"D-Cycloserine~D-Cycloserine: 50 mg/oral one hour prior to extinction task"
10922648|NCT00674570|OG002|Outcome|Arm 3: Placebo|"Placebo~Placebo: One hour prior to extinction task"
10922649|NCT00674570|EG000|Reported Event|Arm 1: Hydrocortisone|"Hydrocortisone~Hydrocortisone: 25 mg/oral one hour prior to extinction task"
10922650|NCT00674570|EG001|Reported Event|Arm 2: D-Cycloserine|"D-Cycloserine~D-Cycloserine: 50 mg/oral one hour prior to extinction task"
10922651|NCT00674570|EG002|Reported Event|Arm 3: Placebo|"Placebo~Placebo: One hour prior to extinction task"
10922652|NCT00674583|BG000|Baseline|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
10922653|NCT00674583|BG001|Baseline|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
10922654|NCT00674583|BG002|Baseline|Total|Total of all reporting groups
10922655|NCT00674583|FG000|Participant Flow|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
10922656|NCT00674583|FG001|Participant Flow|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
10922657|NCT00674583|OG000|Outcome|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
11175235|NCT02028208|BG002|Baseline|Sodium Tetrachloropalladaate (Palladium)|"Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.~Sodium tetrachloropalladate: Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control."
11175236|NCT02028208|BG003|Baseline|Total|Total of all reporting groups
11175237|NCT02028208|FG000|Participant Flow|Ammoniated Mercury|"Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.~Ammoniated mercury: Metal allergen panel containing ascending doses of ammoniated mercury and a negative control."
10922658|NCT00674583|OG001|Outcome|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
10922659|NCT00674583|OG000|Outcome|Nimenrix Group (< 6 Years)|Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
10922660|NCT00674583|OG001|Outcome|Menjugate Group (< 6 Years)|Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
10922661|NCT00674583|OG000|Outcome|Nimenrix Group (≥ 6 Years)|Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
10922662|NCT00674583|OG001|Outcome|Menjugate Group (≥ 6 Years)|Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
10922663|NCT00674583|EG000|Reported Event|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
10922664|NCT00674583|EG001|Reported Event|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
10922665|NCT00674609|BG000|Baseline|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
10922666|NCT00674609|BG001|Baseline|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
10922667|NCT00674609|BG002|Baseline|Placebo|Each 100 uL actuation contained colourant and excipients
10922668|NCT00674609|BG003|Baseline|Total|Total of all reporting groups
10922669|NCT00674609|FG000|Participant Flow|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
10922670|NCT00674609|FG001|Participant Flow|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
10922671|NCT00674609|FG002|Participant Flow|Placebo|Each 100 uL actuation contained colourant and excipients
10922672|NCT00674609|OG000|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
10922673|NCT00674609|OG001|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
10922674|NCT00674609|OG002|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
10922675|NCT00674609|EG000|Reported Event|Sativex|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD
10922676|NCT00674609|EG001|Reported Event|THC Alone|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC
10922677|NCT00674609|EG002|Reported Event|Placebo|Maximum number of daily sprays was 48
10922678|NCT00674622|BG000|Baseline|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
10922679|NCT00674622|BG001|Baseline|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
10922680|NCT00674622|BG002|Baseline|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
10922681|NCT00674622|BG003|Baseline|Total|Total of all reporting groups
10922682|NCT00674622|FG000|Participant Flow|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
10922683|NCT00674622|FG001|Participant Flow|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
10922684|NCT00674622|FG002|Participant Flow|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
10922685|NCT00674622|OG000|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
10922686|NCT00674622|OG001|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
10922687|NCT00674622|OG002|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
10922688|NCT00674622|EG000|Reported Event|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
10922689|NCT00674622|EG001|Reported Event|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
10922690|NCT00674622|EG002|Reported Event|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
10922691|NCT00674661|BG000|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
10922692|NCT00674661|BG001|Baseline|Control Group|riboflavin opthalmic solution without UVA irradiation
10922693|NCT00674661|BG002|Baseline|Total|Total of all reporting groups
10922694|NCT00674661|FG000|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
10922695|NCT00674661|FG001|Participant Flow|Control Group|riboflavin opthalmic solution without UVA irradiation
10922696|NCT00674661|OG000|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
10922697|NCT00674661|OG001|Outcome|Control Group|riboflavin opthalmic solution without UVA irradiation
10922698|NCT00674661|EG000|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
10922699|NCT00674661|EG001|Reported Event|Control Group|riboflavin opthalmic solution without UVA irradiation
10922700|NCT00674700|BG000|Baseline|300 IR|300 IR house dust mites allergen extract tablet
10922701|NCT00674700|BG001|Baseline|500 IR|500 IR house dust mites allergen extract tablet
10922702|NCT00674700|BG002|Baseline|Placebo|Placebo tablet
10922703|NCT00674700|BG003|Baseline|Total|Total of all reporting groups
10922704|NCT00674700|FG000|Participant Flow|300 IR|300 IR house dust mites allergen extract tablet
10922705|NCT00674700|FG001|Participant Flow|500 IR|500 IR house dust mites allergen extract tablet
11175238|NCT02028208|FG001|Participant Flow|Aluminum Chloride and Aluminum Lactate|"Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.~Aluminum chloride and aluminum lactate: Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control."
11191947|NCT02135445|OG000|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
11191948|NCT02135445|OG001|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
10922706|NCT00674700|FG002|Participant Flow|Placebo|Placebo tablet
10922707|NCT00674700|OG000|Outcome|300 IR|300 IR house dust mites allergen extract tablet
10922708|NCT00674700|OG001|Outcome|500 IR|500 IR house dust mites allergen extract tablet
10922709|NCT00674700|OG002|Outcome|Placebo|Placebo tablet
10922710|NCT00674700|EG000|Reported Event|300 IR|300 IR house dust mites allergen extract tablet
10922711|NCT00674700|EG001|Reported Event|500 IR|500 IR house dust mites allergen extract tablet
10922712|NCT00674700|EG002|Reported Event|Placebo|Placebo tablet
10922713|NCT00674739|BG000|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
10922714|NCT00674739|BG001|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
10922715|NCT00674739|BG002|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
10922716|NCT00674739|BG003|Baseline|Total|Total of all reporting groups
10922717|NCT00674739|FG000|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
10922718|NCT00674739|FG001|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
10922719|NCT00674739|FG002|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
10922720|NCT00674739|OG000|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
10922721|NCT00674739|OG001|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
10922722|NCT00674739|OG002|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
10922723|NCT00674739|EG000|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
10922724|NCT00674739|EG001|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
10922725|NCT00674739|EG002|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
10922726|NCT00674765|BG000|Baseline|Seroquel|"Seroquel~Seroquel: 400 mg/day"
10922727|NCT00674765|BG001|Baseline|Placebo|"Placebo~Placebo: 400 mg/day"
10922728|NCT00674765|BG002|Baseline|Total|Total of all reporting groups
10922729|NCT00674765|FG000|Participant Flow|Seroquel|"Seroquel~Seroquel: 400 mg/day"
10922730|NCT00674765|FG001|Participant Flow|Placebo|"Placebo~Placebo: 400 mg/day"
10922731|NCT00674765|OG000|Outcome|Seroquel (Quetiapine)|"Seroquel (quetiapine)~Seroquel: 400 mg/day"
10922732|NCT00674765|OG001|Outcome|Placebo Sugar Pill|"Placebo~Placebo: 400 mg/day"
10922733|NCT00674765|EG000|Reported Event|Seroquel|"Seroquel~Seroquel: 400 mg/day"
10922734|NCT00674765|EG001|Reported Event|Placebo|"Placebo~Placebo: 400 mg/day"
11175239|NCT02028208|FG002|Participant Flow|Sodium Tetrachloropalladaate (Palladium)|"Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.~Sodium tetrachloropalladate: Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control."
11175240|NCT02028208|OG000|Outcome|Ammoniated Mercury|"Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.~Ammoniated mercury: Metal allergen panel containing ascending doses of ammoniated mercury and a negative control."
11191949|NCT02135445|EG000|Reported Event|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
10922735|NCT00674817|BG000|Baseline|Total Population|Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
10922736|NCT00674817|FG000|Participant Flow|Total Population|Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
10922737|NCT00674817|OG000|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
10922738|NCT00674817|OG001|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
10922739|NCT00674817|OG002|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
10922740|NCT00674817|OG003|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
10922741|NCT00674817|OG004|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
10922742|NCT00674817|OG005|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
10922743|NCT00674817|EG000|Reported Event|400 Microgrammes GSK961081 and Salbutamol|400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
10922744|NCT00674817|EG001|Reported Event|1200 Microgrammes GSK961081 and Salbutamol|1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
10922745|NCT00674817|EG002|Reported Event|400 Microgrammes GSK961081 and Ipratropium Bromide|400 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
10922746|NCT00674817|EG003|Reported Event|1200 Microgrammes of GSK961081 and Ipratropium Bromide|1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
10922747|NCT00674817|EG004|Reported Event|400 Microgrammes of GSK961081 and Placebo|400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
10922748|NCT00674817|EG005|Reported Event|1200 Microgrammes of GSK961081 and Placebo|1200 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
10922749|NCT00674973|BG000|Baseline|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
10922750|NCT00674973|BG001|Baseline|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
10922751|NCT00674973|BG002|Baseline|Total|Total of all reporting groups
11175241|NCT02028208|OG001|Outcome|Aluminum Chloride and Aluminum Lactate|"Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.~Aluminum chloride and aluminum lactate: Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control."
11175242|NCT02028208|OG002|Outcome|Sodium Tetrachloropalladaate (Palladium)|"Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.~Sodium tetrachloropalladate: Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control."
11175243|NCT02028208|EG000|Reported Event|Ammoniated Mercury|"Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.~It was impossible to know which allergen dose was associated with a related adverse event"
11175244|NCT02028208|EG001|Reported Event|Aluminum Chloride and Aluminum Lactate|"Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.~It was impossible to know which allergen dose was associated with a related adverse event"
11175245|NCT02028208|EG002|Reported Event|Sodium Tetrachloropalladaate (Palladium)|"Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.~It was impossible to know which allergen dose was associated with a related adverse event"
11175246|NCT02028221|BG000|Baseline|Placebo|"1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)~Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)"
11175247|NCT02028221|BG001|Baseline|Metformin|"metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.~Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period."
11175248|NCT02028221|BG002|Baseline|Total|Total of all reporting groups
11175249|NCT02028221|FG000|Participant Flow|Placebo|"1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)~Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)"
11175250|NCT02028221|FG001|Participant Flow|Metformin|"metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.~Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period."
11175251|NCT02028221|OG000|Outcome|Placebo|"1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)~Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)"
11175252|NCT02028221|OG001|Outcome|Metformin|"metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.~Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period."
11175253|NCT02028221|EG000|Reported Event|Placebo|"1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)~Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)"
11191950|NCT02135445|EG001|Reported Event|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
11191951|NCT02135614|BG000|Baseline|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
11191952|NCT02135614|BG001|Baseline|Placebo|Single dose of placebo tablets
11191953|NCT02135614|BG002|Baseline|Total|Total of all reporting groups
11191954|NCT02135614|FG000|Participant Flow|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
11191955|NCT02135614|FG001|Participant Flow|Placebo|Single dose of placebo tablets
11191956|NCT02135614|OG000|Outcome|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
11191957|NCT02135614|OG001|Outcome|Placebo|Single dose of placebo tablets
11191958|NCT02135614|EG000|Reported Event|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
11191959|NCT02135614|EG001|Reported Event|Placebo|Single dose of placebo tablets
11191960|NCT02135653|BG000|Baseline|Feasibility/Phase II: Radiotherapy and Eischens Yoga|Radiotherapy and Eischens Yoga
11191961|NCT02135653|BG001|Baseline|Phase II: Radiotherapy Without Eischens Yoga|Radiotherapy without Eischens Yoga
11191962|NCT02135653|BG002|Baseline|Total|Total of all reporting groups
11191963|NCT02135653|FG000|Participant Flow|Feasibility/Phase II: Radiotherapy and Eischens Yoga|Radiotherapy and Eischens Yoga
11191964|NCT02135653|FG001|Participant Flow|Phase II: Radiotherapy Without Eischens Yoga|Radiotherapy without Eischens Yoga
11191965|NCT02135653|OG000|Outcome|Feasibility/Phase II: Radiotherapy and Eischens Yoga|Radiotherapy with Eischens Yoga
11191966|NCT02135653|OG001|Outcome|Phase II: Radiotherapy Without Eischens Yoga|Radiotherapy without Eischens Yoga
11191967|NCT02135653|OG001|Outcome|Phase II: Radiotherapy Without Eischens Yoga|Radiotherapy
11191968|NCT02135653|OG001|Outcome|Phase II: Radiotherapy Without Eischens Yoga|"Radiotherapy~Without Eischens Yoga"
11191969|NCT02135653|EG000|Reported Event|Feasibility/Phase II: Radiotherapy and Eischens Yoga|Radiotherapy and Eischens Yoga
11191970|NCT02135653|EG001|Reported Event|Phase II: Radiotherapy Wihtout Eischens Yoga|Radiotherapy without Eischens Yoga
11191971|NCT02135692|BG000|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
11191972|NCT02135692|FG000|Participant Flow|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
11191973|NCT02135692|OG000|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
11191974|NCT02135692|EG000|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
11191975|NCT02135848|BG000|Baseline|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
11191976|NCT02135848|BG001|Baseline|Placebo|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
11191977|NCT02135848|BG002|Baseline|Total|Total of all reporting groups
11191978|NCT02135848|FG000|Participant Flow|GSK1278863|Eligible participants received an initial single high dose of 300 milligram (mg) GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
11191979|NCT02135848|FG001|Participant Flow|Placebo|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
11191980|NCT02135848|OG000|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
11191981|NCT02135848|OG001|Outcome|Placebo Matched With GSK1278863 300 mg|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally.
11191982|NCT02135848|OG002|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
11191983|NCT02135848|OG003|Outcome|Placebo Matched With GSK1278863 15 mg|Eligible participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
11191984|NCT02135848|OG000|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
11191985|NCT02135848|OG001|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
11191986|NCT02135848|OG001|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
11191987|NCT02135848|EG000|Reported Event|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
11191988|NCT02135848|EG001|Reported Event|Placebo Matched With GSK1278863 300 mg|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally.
11191989|NCT02135848|EG002|Reported Event|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
11191990|NCT02135848|EG003|Reported Event|Placebo Matched With GSK1278863 15 mg|Eligible participants received placebo matched with 15 mg GSK1278863 tablets orally for 14 days.
11234101|NCT02432235|FG003|Participant Flow|13 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234102|NCT02432235|FG004|Participant Flow|20 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10922752|NCT00674973|FG000|Participant Flow|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
10922753|NCT00674973|FG001|Participant Flow|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
10922754|NCT00674973|OG000|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
10922755|NCT00674973|OG001|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
10922756|NCT00674973|EG000|Reported Event|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
10922757|NCT00674973|EG001|Reported Event|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
10922758|NCT00674986|BG000|Baseline|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
10922759|NCT00674986|BG001|Baseline|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
10922760|NCT00674986|BG002|Baseline|Total|Total of all reporting groups
10922761|NCT00674986|FG000|Participant Flow|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
10922762|NCT00674986|FG001|Participant Flow|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
10922763|NCT00674986|OG000|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
10922764|NCT00674986|OG001|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
10922765|NCT00674986|OG000|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
10922766|NCT00674986|EG000|Reported Event|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
10922767|NCT00674986|EG001|Reported Event|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
10922768|NCT00675025|BG000|Baseline|Prior Donepezil-DB|Participants who received donepezil in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42.
10922769|NCT00675025|BG001|Baseline|Prior Placebo-DB|Participants who received matched placebo in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42.
10922770|NCT00675025|BG002|Baseline|Total|Total of all reporting groups
10922771|NCT00675025|FG000|Participant Flow|Prior Donepezil-DB|Participants who received donepezil in the double-blind study E2020-A001-219 (NCT00570128) were continued in this open label extension (OLE) study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 milligram per kilogram per day (mg/kg/day) using liquid formulated at 5 mg/5 milliliter (mL) for up to approximately Week 42.
10922772|NCT00675025|FG001|Participant Flow|Prior Placebo-DB|Participants who received matched placebo in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42.
10922773|NCT00675025|OG000|Outcome|Prior Donepezil-DB|Participants who received donepezil in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42.
10922774|NCT00675025|OG001|Outcome|Prior Placebo-DB|Participants who received matched placebo in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42.
11234103|NCT02432235|FG005|Participant Flow|30 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234104|NCT02432235|FG006|Participant Flow|45 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234105|NCT02432235|FG007|Participant Flow|60 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234106|NCT02432235|FG008|Participant Flow|80 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234107|NCT02432235|FG009|Participant Flow|100 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10922775|NCT00675025|EG000|Reported Event|Prior Donepezil-DB|Participants who received donepezil in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42.
10922776|NCT00675025|EG001|Reported Event|Prior Placebo-DB|Participants who received matched placebo in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL up to approximately Week 42.
10922777|NCT00675103|BG000|Baseline|Pegloticase 8 mg Every 2 Wks|
10922778|NCT00675103|FG000|Participant Flow|Pegloticase 8 mg Every 2 Wks|
11234108|NCT02432235|FG010|Participant Flow|150 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10922779|NCT00675103|OG000|Outcome|Pegloticase 8 mg Every 2 Wks|
10922780|NCT00675103|EG000|Reported Event|Pegloticase 8 mg Every 2 Wks|
11234109|NCT02432235|FG011|Participant Flow|300 μg/kg|"A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).~Camidanlumab tesirine: Intravenous (IV) infusion."
11234110|NCT02432235|OG000|Outcome|3 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234111|NCT02432235|OG001|Outcome|5 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234112|NCT02432235|OG002|Outcome|8 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234113|NCT02432235|OG003|Outcome|13 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234114|NCT02432235|OG004|Outcome|20 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10922781|NCT00675259|BG000|Baseline|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
11234115|NCT02432235|OG005|Outcome|30 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234116|NCT02432235|OG006|Outcome|45 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234117|NCT02432235|OG007|Outcome|60 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234118|NCT02432235|OG008|Outcome|80 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234119|NCT02432235|OG009|Outcome|100 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234120|NCT02432235|OG010|Outcome|150 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234121|NCT02432235|OG011|Outcome|300 μg/kg|"A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).~Camidanlumab tesirine: Intravenous (IV) infusion."
10922782|NCT00675259|FG000|Participant Flow|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
10922783|NCT00675259|OG000|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
10922784|NCT00675259|OG000|Outcome|Adjuvant Bevacizumab|Patients received 6 months of adjuvant bevacizumab therapy
10922785|NCT00675259|OG000|Outcome|Patients With TNBC|Women with triple negative breast cancer (TNBC)
10922786|NCT00675259|OG001|Outcome|Patients With pCR|Pathologic complete response (pCR)
10922787|NCT00675259|OG002|Outcome|Patients With Hormone-responsive BC|Hormone-responsive breast cancer (BC)
10922788|NCT00675259|EG000|Reported Event|Toxicities During Neoadjuvant Chemotherapy|
10922789|NCT00675415|BG000|Baseline|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
10922790|NCT00675415|BG001|Baseline|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
10922791|NCT00675415|BG002|Baseline|Total|Total of all reporting groups
10922792|NCT00675415|FG000|Participant Flow|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
10922793|NCT00675415|FG001|Participant Flow|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
11175254|NCT02028221|EG001|Reported Event|Metformin|"metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.~Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period."
10922794|NCT00675415|OG000|Outcome|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
11175255|NCT02028247|BG000|Baseline|Personalized Cognitive-behavioral Therapy|"Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.~Personalized Cognitive-behavioral therapy"
11175256|NCT02028247|BG001|Baseline|Standard Practice Cognitive-behavioral Therapy|"Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.~Standard Practice Cognitive-behavioral therapy"
10922795|NCT00675415|OG001|Outcome|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
10922796|NCT00675415|EG000|Reported Event|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
10922797|NCT00675415|EG001|Reported Event|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
10922798|NCT00675428|BG000|Baseline|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
10922799|NCT00675428|BG001|Baseline|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
10922800|NCT00675428|BG002|Baseline|Total|Total of all reporting groups
10922801|NCT00675428|FG000|Participant Flow|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
10922802|NCT00675428|FG001|Participant Flow|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
10922803|NCT00675428|OG000|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
10922804|NCT00675428|OG001|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
10922805|NCT00675428|EG000|Reported Event|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
10922806|NCT00675428|EG001|Reported Event|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
10922807|NCT00675441|BG000|Baseline|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
10922808|NCT00675441|FG000|Participant Flow|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
10922809|NCT00675441|OG000|Outcome|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
11175257|NCT02028247|BG002|Baseline|Treatment as Usual|"Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as Usual"
11175258|NCT02028247|BG003|Baseline|Total|Total of all reporting groups
10922810|NCT00675441|EG000|Reported Event|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
10922811|NCT00675506|BG000|Baseline|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
10922812|NCT00675506|BG001|Baseline|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
10922813|NCT00675506|BG002|Baseline|Total|Total of all reporting groups
10922814|NCT00675506|FG000|Participant Flow|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
10922815|NCT00675506|FG001|Participant Flow|Placebo|"Participants received treatment with placebo medication.~Placebo : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
10922816|NCT00675506|OG000|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
10922817|NCT00675506|OG001|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
10922818|NCT00675506|OG000|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
10922819|NCT00675506|EG000|Reported Event|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
10922820|NCT00675506|EG001|Reported Event|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
10922821|NCT00675558|BG000|Baseline|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
10922822|NCT00675558|BG001|Baseline|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
10922823|NCT00675558|BG002|Baseline|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
10922824|NCT00675558|BG003|Baseline|Total|Total of all reporting groups
10922825|NCT00675558|FG000|Participant Flow|Non-Obese (NO)|Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
10922826|NCT00675558|FG001|Participant Flow|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
10922827|NCT00675558|FG002|Participant Flow|Super-morbidly Obese (SMO)|"Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.~10 subjects of the original 30 subjects enrolled into this group received a second bariatric procedure. The remaining 20 subjects of the original 30 subjects did not continue on to the second phase (initial bariatric surgery) of the study."
10922828|NCT00675558|OG000|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
10922829|NCT00675558|OG001|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
10922830|NCT00675558|OG002|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
10922831|NCT00675558|EG000|Reported Event|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
10922832|NCT00675558|EG001|Reported Event|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
11175259|NCT02028247|FG000|Participant Flow|Personalized Cognitive-behavioral Therapy|"Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.~Personalized Cognitive-behavioral therapy"
10922833|NCT00675558|EG002|Reported Event|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
10922834|NCT00675584|BG000|Baseline|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
10922835|NCT00675584|BG001|Baseline|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
10922836|NCT00675584|BG002|Baseline|Total|Total of all reporting groups
10922837|NCT00675584|FG000|Participant Flow|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
10922838|NCT00675584|FG001|Participant Flow|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
10922839|NCT00675584|OG000|Outcome|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
10922840|NCT00675584|OG001|Outcome|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
10922841|NCT00675584|EG000|Reported Event|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
10922842|NCT00675584|EG001|Reported Event|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
10922843|NCT00675597|BG000|Baseline|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
11357625|NCT03752151|OG000|Outcome|MARVEL 2 Monitor Mode Then MARVEL 2 Adaptive|Participants were programmed to MARVEL 2 algorithm monitor mode which provides standard VVI pacing for approximately 20 minutes. Then the MARVEL 2 algorithm was programmed to adaptive mode which provides VDD pacing for approximately 2 hours.
10922844|NCT00675597|FG000|Participant Flow|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
10922845|NCT00675597|OG000|Outcome|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
10922846|NCT00675597|EG000|Reported Event|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
10922847|NCT00675766|BG000|Baseline|Group 1|HIV-positive adults 50 and older
10922848|NCT00675766|BG001|Baseline|Group 2|HIV-positive adults 18-40 years old
10922849|NCT00675766|BG002|Baseline|Group 3|HIV-negative controls 50 and older
10922850|NCT00675766|BG003|Baseline|Group 4|HIV-negative controls 18-40 years old
10922851|NCT00675766|BG004|Baseline|Total|Total of all reporting groups
10922852|NCT00675766|FG000|Participant Flow|Group 1|HIV-positive adults 50 and older
10922853|NCT00675766|FG001|Participant Flow|Group 2|HIV-positive adults 18-40 years old
10922854|NCT00675766|FG002|Participant Flow|Group 3|HIV-negative controls 50 and older
10922855|NCT00675766|FG003|Participant Flow|Group 4|HIV-negative controls 18-40 years old
10922856|NCT00675766|OG000|Outcome|Group 1|HIV-positive adults 50 and older
10922857|NCT00675766|OG001|Outcome|Group 2|HIV-positive adults 18-40 years old
10922858|NCT00675766|OG002|Outcome|Group 3|HIV-negative controls 50 and older
10922859|NCT00675766|OG003|Outcome|Group 4|HIV-negative controls 18-40 years old
10922860|NCT00675766|EG000|Reported Event|Group 1|HIV-positive adults 50 and older
10922861|NCT00675766|EG001|Reported Event|Group 2|HIV-positive adults 18-40 years old
10922862|NCT00675766|EG002|Reported Event|Group 3|HIV-negative controls 50 and older
10922863|NCT00675766|EG003|Reported Event|Group 4|HIV-negative controls 18-40 years old
10922864|NCT00675792|BG000|Baseline|Sugammadex|4 mg/kg sugammadex
10922865|NCT00675792|BG001|Baseline|Neostigmine|50 µg/kg neostigmine
10922866|NCT00675792|BG002|Baseline|Total|Total of all reporting groups
10922867|NCT00675792|FG000|Participant Flow|Sugammadex|4 mg/kg sugammadex
10922868|NCT00675792|FG001|Participant Flow|Neostigmine|50 µg/kg neostigmine
10922869|NCT00675792|OG000|Outcome|Sugammadex|4 mg/kg sugammadex
11191991|NCT02135861|BG000|Baseline|Healthy Volunteers|Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10922870|NCT00675792|OG001|Outcome|Neostigmine|50 µg/kg neostigmine
10922871|NCT00675792|EG000|Reported Event|Sugammadex|4 mg/kg sugammadex
10922872|NCT00675792|EG001|Reported Event|Neostigmine|50 µg/kg neostigmine
10922873|NCT00675909|BG000|Baseline|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
10922874|NCT00675909|BG001|Baseline|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
10922875|NCT00675909|BG002|Baseline|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
10922876|NCT00675909|BG003|Baseline|Total|Total of all reporting groups
10922877|NCT00675909|FG000|Participant Flow|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
10922878|NCT00675909|FG001|Participant Flow|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
10922879|NCT00675909|FG002|Participant Flow|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
10922880|NCT00675909|OG000|Outcome|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
10922881|NCT00675909|OG001|Outcome|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
10922882|NCT00675909|OG002|Outcome|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
10922883|NCT00675909|EG000|Reported Event|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
10922884|NCT00675909|EG001|Reported Event|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
10922885|NCT00675909|EG002|Reported Event|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
10922886|NCT00675922|BG000|Baseline|Sulfamylon vs Silver Nitrate Solution|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
10922887|NCT00675922|FG000|Participant Flow|Sulfamylon Solution 5% and Silver Nitrate Soaks|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
10922888|NCT00675922|OG000|Outcome|Percent Infections:Sulfamylon Site|Percent of sites that developed infections with Sulfamylon soaks
10922889|NCT00675922|OG001|Outcome|Percent Infections: Silver Nitrate Site|Percent of sites that developed infections with Silver Nitrate soaks
10922890|NCT00675922|EG000|Reported Event|Sulfamylon Soaks, Silver Nitrate Soaks|Patients receive both treatments and each treated site is compared.
10922891|NCT00675948|BG000|Baseline|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
10922892|NCT00675948|BG001|Baseline|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
10922893|NCT00675948|BG002|Baseline|Total|Total of all reporting groups
10922894|NCT00675948|FG000|Participant Flow|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
10922895|NCT00675948|FG001|Participant Flow|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
10922896|NCT00675948|OG000|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)
10922897|NCT00675948|OG001|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
10922898|NCT00675948|OG000|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
10922899|NCT00675948|EG000|Reported Event|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
10922900|NCT00675948|EG001|Reported Event|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
10922901|NCT00675987|BG000|Baseline|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
10922902|NCT00675987|BG001|Baseline|Placebo 1 Tab po QD|Placebo 1 tab po QD
10922903|NCT00675987|BG002|Baseline|Total|Total of all reporting groups
10922904|NCT00675987|FG000|Participant Flow|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
10922905|NCT00675987|FG001|Participant Flow|Placebo 1 Tab po QD|Placebo 1 tab po QD
11175260|NCT02028247|FG001|Participant Flow|Standard Practice Cognitive-behavioral Therapy|"Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.~Standard Practice Cognitive-behavioral therapy"
11175261|NCT02028247|FG002|Participant Flow|Treatment as Usual|"Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as Usual"
11175262|NCT02028247|OG000|Outcome|Personalized Cognitive-behavioral Therapy|"Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.~Personalized Cognitive-behavioral therapy"
11175263|NCT02028247|OG001|Outcome|Standard Practice Cognitive-behavioral Therapy|"Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.~Standard Practice Cognitive-behavioral therapy"
10922906|NCT00675987|OG000|Outcome|Placebo|Placebo 1 tab po QD
10922907|NCT00675987|OG001|Outcome|Losartan|Losartan 100 mg 1 tab po QD
11175264|NCT02028247|OG002|Outcome|Treatment as Usual|"Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as Usual"
10922908|NCT00675987|OG000|Outcome|Placebo|"Placebo 1 tab po QD~Placebo control: Placebo 1 po QD"
10922909|NCT00675987|OG001|Outcome|Losartan|"Losartan 100 mg 1 tab po QD~losartan: losartan 100 mg tablets 1 tab po QD"
10922910|NCT00675987|EG000|Reported Event|Losartan|Losartan 100 mg 1 tab po QD
10922911|NCT00675987|EG001|Reported Event|Placebo|Placebo 1 tab po QD
10922912|NCT00676013|BG000|Baseline|Alloderm, Integra, Homograft, and/or Autograft|Grafting with alloderm, integra, homograft and/or autograft. Various treatment sites were then compared.
10922913|NCT00676013|FG000|Participant Flow|Alloderm, Integra, Homograft, Autograft|Grafting with alloderm, Integra, Homograft, and/or Autograft on each patient. Different sites were then compared.
10922914|NCT00676013|OG000|Outcome|AlloDerm|Surgery using alloDerm. Various treatment sites were then compared.
10922915|NCT00676013|OG001|Outcome|Integra|Surgery with Integra grafting followed with autografting
10922916|NCT00676013|OG002|Outcome|Homograft|Surgery using Homograft followed with autografting
10922917|NCT00676013|OG003|Outcome|Autograft|Surgery with Autografting
10922918|NCT00676013|EG000|Reported Event|AlloDerm, Integra, Homograft, Autograft|Skin product used on each of the four test sites on each patient
10922919|NCT00676052|BG000|Baseline|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
10922920|NCT00676052|BG001|Baseline|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
10922921|NCT00676052|BG002|Baseline|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
10922922|NCT00676052|BG003|Baseline|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
10922923|NCT00676052|BG004|Baseline|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
10922924|NCT00676052|BG005|Baseline|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
10922925|NCT00676052|BG006|Baseline|Total|Total of all reporting groups
10922926|NCT00676052|FG000|Participant Flow|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
10922927|NCT00676052|FG001|Participant Flow|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 micrograms (mcg) administered once daily via a novel dry powder inhaler.
10922928|NCT00676052|FG002|Participant Flow|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
10922929|NCT00676052|FG003|Participant Flow|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
10922930|NCT00676052|FG004|Participant Flow|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
11175265|NCT02028247|EG000|Reported Event|Personalized Cognitive-behavioral Therapy|"Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.~Personalized Cognitive-behavioral therapy"
11175266|NCT02028247|EG001|Reported Event|Standard Practice Cognitive-behavioral Therapy|"Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.~Standard Practice Cognitive-behavioral therapy"
11175267|NCT02028247|EG002|Reported Event|Treatment as Usual|"Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as Usual"
11175268|NCT02028325|BG000|Baseline|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
11175269|NCT02028325|FG000|Participant Flow|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
11175270|NCT02028325|OG000|Outcome|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
10922931|NCT00676052|FG005|Participant Flow|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
10922932|NCT00676052|OG000|Outcome|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
10922933|NCT00676052|OG001|Outcome|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
10922934|NCT00676052|OG002|Outcome|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
10922935|NCT00676052|OG003|Outcome|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
10922936|NCT00676052|OG004|Outcome|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
10922937|NCT00676052|OG005|Outcome|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
10922938|NCT00676052|EG000|Reported Event|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
10922939|NCT00676052|EG001|Reported Event|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
10922940|NCT00676052|EG002|Reported Event|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
10922941|NCT00676052|EG003|Reported Event|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
10922942|NCT00676052|EG004|Reported Event|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
10922943|NCT00676052|EG005|Reported Event|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
10922944|NCT00676065|BG000|Baseline|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
10922945|NCT00676065|BG001|Baseline|OC-LNG|Users of oral contraceptives containing levonorgestrel
11175271|NCT02028325|EG000|Reported Event|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
10922946|NCT00676065|BG002|Baseline|OC-other|Users of oral contraceptives containing other progestogens
10922947|NCT00676065|BG003|Baseline|Total|Total of all reporting groups
10922948|NCT00676065|FG000|Participant Flow|Yasmin|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
10922949|NCT00676065|FG001|Participant Flow|OC-LNG|Users of oral contraceptives containing levonorgestrel
10922950|NCT00676065|FG002|Participant Flow|OC-other|Users of oral contraceptives containing other progestogens
10922951|NCT00676065|OG000|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
10922952|NCT00676065|OG001|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
10922953|NCT00676065|OG002|Outcome|OC-other|Users of oral contraceptives containing other progestogens
11191992|NCT02135861|BG001|Baseline|Heart Failure Participants|Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10922954|NCT00676065|EG000|Reported Event|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
10922955|NCT00676065|EG001|Reported Event|OC-LNG|Users of oral contraceptives containing levonorgestrel
10922956|NCT00676065|EG002|Reported Event|OC-other|Users of oral contraceptives containing other progestogens
10922957|NCT00676091|BG000|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10922958|NCT00676091|BG001|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10922959|NCT00676091|BG002|Baseline|Total|Total of all reporting groups
10922960|NCT00676091|FG000|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10922961|NCT00676091|FG001|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10922962|NCT00676091|OG000|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10922963|NCT00676091|OG001|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10922964|NCT00676091|EG000|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
10922965|NCT00676091|EG001|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
10922966|NCT00676091|EG002|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
10922967|NCT00676091|EG003|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
10922968|NCT00676091|EG004|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=81; systematic (solicited) Systemic Events N=84. Total N at Risk=155: 1 participant had no record of safety information during the Toddler dose period and was not included in the Safety population."
10922969|NCT00676091|EG005|Reported Event|Toddler Dose 7vPnC|"7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=64; systematic (solicited) Local Reactions N=67; systematic (solicited) Systemic Events N=86."
10922970|NCT00676130|BG000|Baseline|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
10922971|NCT00676130|BG001|Baseline|Placebo|Cephalexin plus placebo
10922972|NCT00676130|BG002|Baseline|Total|Total of all reporting groups
10922973|NCT00676130|FG000|Participant Flow|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
10922974|NCT00676130|FG001|Participant Flow|Placebo|Cephalexin plus placebo
10922975|NCT00676130|OG000|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
10922976|NCT00676130|OG001|Outcome|Placebo|Cephalexin plus placebo
10922977|NCT00676130|EG000|Reported Event|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
10922978|NCT00676130|EG001|Reported Event|Placebo|Cephalexin plus placebo
10922979|NCT00676143|BG000|Baseline|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
10922980|NCT00676143|BG001|Baseline|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
10922981|NCT00676143|BG002|Baseline|Total|Total of all reporting groups
10922982|NCT00676143|FG000|Participant Flow|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
10922983|NCT00676143|FG001|Participant Flow|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
10922984|NCT00676143|OG000|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
10922985|NCT00676143|OG001|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
10922986|NCT00676143|OG001|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
10922987|NCT00676143|EG000|Reported Event|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
10922988|NCT00676143|EG001|Reported Event|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
10922989|NCT00676182|BG000|Baseline|Telerehabilitation TBI|"Telerehabilitation TBI~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI"
10922990|NCT00676182|BG001|Baseline|Telerehabilitation TBI/PTSD|"Telerehabilitation TBI/PTSD~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI and comorbid PTSD"
10922991|NCT00676182|BG002|Baseline|Total|Total of all reporting groups
10922992|NCT00676182|FG000|Participant Flow|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
10922993|NCT00676182|OG000|Outcome|Telerehabilitation|"Telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects"
10922994|NCT00676182|OG000|Outcome|Telerehabilitation Baseline|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
10922995|NCT00676182|OG001|Outcome|Telerehabilitation 6 Months|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
10922996|NCT00676182|OG002|Outcome|Telerehabilitation 12 Months|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
10922997|NCT00676182|OG000|Outcome|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
10922998|NCT00676182|OG000|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for TBI/PTSD"
10922999|NCT00676182|OG000|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
10923000|NCT00676182|EG000|Reported Event|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
10923001|NCT00676195|BG000|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
10923002|NCT00676195|FG000|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
10923003|NCT00676195|OG000|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
10923004|NCT00676195|OG000|Outcome|Open-Label|
10923005|NCT00676195|EG000|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
10923006|NCT00676208|BG000|Baseline|SMA Participants|Medical Students who were assigned to observe Shared Medical Appointments (SMA).
10923007|NCT00676208|BG001|Baseline|Comparison|Medical students who do not experience Shared Medical Appointments.
10923008|NCT00676208|BG002|Baseline|Total|Total of all reporting groups
10923009|NCT00676208|FG000|Participant Flow|Intervention|Medical Students who are assigned to observe Shared Medical Appointments.
10923010|NCT00676208|FG001|Participant Flow|Comparison|Medical students who do not experience Shared Medical Appointments during the study period April to August 2008.
10923011|NCT00676208|OG000|Outcome|SMA Participants|Medical students who are assigned to observe Shared Medical Appointments (SMA).
10923012|NCT00676208|OG001|Outcome|Comparison|Medical Students who do not experience Shared Medical Appointments.
10923013|NCT00676208|OG000|Outcome|SMA Particiants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
10923014|NCT00676208|OG001|Outcome|Comparison|Medical students who do not experience Shared Medical Appointments (SMA).
11175272|NCT02028676|BG000|Baseline|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
11175273|NCT02028676|BG001|Baseline|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
11175274|NCT02028676|BG002|Baseline|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923015|NCT00676208|EG000|Reported Event|SMA Participants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
10923016|NCT00676208|EG001|Reported Event|Comparison|Medical students who do not experience Shared Medical Appointments.
10923017|NCT00676338|BG000|Baseline|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
10923018|NCT00676338|BG001|Baseline|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
10923019|NCT00676338|BG002|Baseline|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
10923020|NCT00676338|BG003|Baseline|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
10923021|NCT00676338|BG004|Baseline|Total|Total of all reporting groups
10923022|NCT00676338|FG000|Participant Flow|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
10923023|NCT00676338|FG001|Participant Flow|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
10923024|NCT00676338|FG002|Participant Flow|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
10923025|NCT00676338|FG003|Participant Flow|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
10923026|NCT00676338|OG000|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
10923027|NCT00676338|OG001|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
10923028|NCT00676338|OG002|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
10923029|NCT00676338|OG003|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
10923030|NCT00676338|EG000|Reported Event|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
10923031|NCT00676338|EG001|Reported Event|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
10923032|NCT00676338|EG002|Reported Event|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
10923033|NCT00676338|EG003|Reported Event|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
10923034|NCT00676364|BG000|Baseline|ControI Group Receiving Placebo Cream Before Venipuncture|Experimential group receiving medicated topical cream prior to venipuncture
10923035|NCT00676364|BG001|Baseline|Investigational Group|Investigational group receiving blinded 4% lidocaine cream
10923036|NCT00676364|BG002|Baseline|Total|Total of all reporting groups
10923037|NCT00676364|FG000|Participant Flow|ControI Group Receiving Placebo Cream|Control group receiving blinded placebo cream under occlusive dressing prior to venipuncture
10923038|NCT00676364|FG001|Participant Flow|Investigational Group Receiving 4% Lidocaine|Investigational group receiving blinded 4% lidocaine cream under occlusive dressing for 15 mins prior to venipuncture
10923039|NCT00676364|OG000|Outcome|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
10923040|NCT00676364|OG001|Outcome|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
10923041|NCT00676364|OG000|Outcome|ControI Group Receiving Placebo Cream|The control group received blinded placebo cream under occlusive dressing for 15 minutes prior to venipuncture.
10923042|NCT00676364|OG001|Outcome|Investigational Group Receiving 4% Lidocaine Cream|The investigational group received blinded 4% lidocaine cream under occlusive dressing for 15 minutes prior to venipuncture.
10923043|NCT00676364|EG000|Reported Event|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
10923044|NCT00676364|EG001|Reported Event|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
10923045|NCT00676403|BG000|Baseline|Placebo|Single daily oral dose.
10923046|NCT00676403|BG001|Baseline|Pregabalin 50 mg|Single daily 50 mg oral dose.
10923047|NCT00676403|BG002|Baseline|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
10923048|NCT00676403|BG003|Baseline|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
10923049|NCT00676403|BG004|Baseline|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
10923050|NCT00676403|BG005|Baseline|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
10923051|NCT00676403|BG006|Baseline|Total|Total of all reporting groups
10923052|NCT00676403|FG000|Participant Flow|Placebo|Single daily oral dose.
10923053|NCT00676403|FG001|Participant Flow|Pregabalin 50 mg|Single daily 50 mg oral dose.
10923054|NCT00676403|FG002|Participant Flow|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
10923055|NCT00676403|FG003|Participant Flow|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
10923056|NCT00676403|FG004|Participant Flow|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
10923057|NCT00676403|FG005|Participant Flow|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
10923058|NCT00676403|OG000|Outcome|Placebo|Single daily oral dose.
10923059|NCT00676403|OG001|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
10923060|NCT00676403|OG002|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
10923061|NCT00676403|OG003|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
10923062|NCT00676403|OG004|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
10923063|NCT00676403|OG005|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
10923064|NCT00676403|OG000|Outcome|Placebo|
10923065|NCT00676403|OG001|Outcome|Pregabalin 50 mg/Day|
10923066|NCT00676403|OG002|Outcome|Pregabalin 100 mg/Day|
10923067|NCT00676403|OG003|Outcome|Pregabalin 150 mg/Day|
10923068|NCT00676403|OG004|Outcome|Pregabalin 300 mg/Day|
10923069|NCT00676403|OG005|Outcome|Pregablin 450 mg/Day|
10923070|NCT00676403|EG000|Reported Event|Placebo|Single daily oral dose.
10923071|NCT00676403|EG001|Reported Event|Pregabalin 50 mg|Single daily 50 mg oral dose.
10923072|NCT00676403|EG002|Reported Event|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
10923073|NCT00676403|EG003|Reported Event|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
10923074|NCT00676403|EG004|Reported Event|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
10923075|NCT00676403|EG005|Reported Event|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
10923076|NCT00676520|BG000|Baseline|Subjects Receiving the XIENCE V EECSS|
10923077|NCT00676520|FG000|Participant Flow|Subjects Receiving the XIENCE V EECSS|
10923078|NCT00676520|OG000|Outcome|Subjects Receiving the XIENCE V EECSS|
10923079|NCT00676520|OG000|Outcome|Physical Limitations|
10923080|NCT00676520|OG001|Outcome|Angina Stability|
10923081|NCT00676520|OG002|Outcome|Angina Frequency|
10923082|NCT00676520|OG003|Outcome|Treatment Satisfaction|
10923083|NCT00676520|OG004|Outcome|Perception of Disease/Quality of Life|
10923084|NCT00676520|EG000|Reported Event|Subjects Receiving the XIENCE V EECSS|
10923085|NCT00676572|BG000|Baseline|Severe Asthma|Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
10923086|NCT00676572|BG001|Baseline|Non-severe Asthma|Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
10923087|NCT00676572|BG002|Baseline|Total|Total of all reporting groups
10923088|NCT00676572|FG000|Participant Flow|Severe Asthma|Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
10923089|NCT00676572|FG001|Participant Flow|Non-severe Asthma|Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
10923090|NCT00676572|OG000|Outcome|Severe Asthma|Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
10923091|NCT00676572|OG001|Outcome|Non-severe Asthma|Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
10923092|NCT00676572|EG000|Reported Event|Severe Asthma|Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
10923093|NCT00676572|EG001|Reported Event|Non-severe Asthma|Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
10923094|NCT00676585|BG000|Baseline|Control|Normal Saline
10923095|NCT00676585|BG001|Baseline|Intervention|Hydrocortisone
10923096|NCT00676585|BG002|Baseline|Total|Total of all reporting groups
10923097|NCT00676585|FG000|Participant Flow|Control|Normal Saline
10923098|NCT00676585|FG001|Participant Flow|Intervention|Hydrocortisone
10923099|NCT00676585|OG000|Outcome|Control|Normal Saline
11175275|NCT02028676|BG003|Baseline|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
11191993|NCT02135861|BG002|Baseline|Acute Decompensated Heart Failure Participants|Acute Decompensated Heart Failure participants following hospitalization due to pulmonary oedema was placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
11191994|NCT02135861|BG003|Baseline|Total|Total of all reporting groups
10923100|NCT00676585|OG001|Outcome|Intervention|Hydrocortisone
10923101|NCT00676585|EG000|Reported Event|Control|Normal Saline
10923102|NCT00676585|EG001|Reported Event|Intervention|Hydrocortisone
10923103|NCT00676650|BG000|Baseline|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
10923104|NCT00676650|BG001|Baseline|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
10923105|NCT00676650|BG002|Baseline|Total|Total of all reporting groups
10923106|NCT00676650|FG000|Participant Flow|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
10923107|NCT00676650|FG001|Participant Flow|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
10923108|NCT00676650|OG000|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
10923109|NCT00676650|OG001|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
10923110|NCT00676650|EG000|Reported Event|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
10923111|NCT00676650|EG001|Reported Event|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
10923112|NCT00676676|BG000|Baseline|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
10923113|NCT00676676|FG000|Participant Flow|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
10923114|NCT00676676|OG000|Outcome|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
10923115|NCT00676676|EG000|Reported Event|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
10923116|NCT00676689|BG000|Baseline|SAPIEN THV|
10923117|NCT00676689|FG000|Participant Flow|SAPIEN THV|
10923118|NCT00676689|OG000|Outcome|SAPIEN THV|
10923119|NCT00676689|EG000|Reported Event|SAPIEN THV|
10923120|NCT00676780|BG000|Baseline|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
10923121|NCT00676780|FG000|Participant Flow|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
10923122|NCT00676780|OG000|Outcome|ECGC Extract|Single arm for a phase II study of the effects of Epigallocatechin Gallate (ECGC) polyphenol extract from green tea on biomarkers in patients with prostate cancer.
10923123|NCT00676780|OG000|Outcome|ECGC Extract|Single arm for a phase II study of the effects of ECGC polyphenol extract from green tea on biomarkers in patients with prostate cancer.
10923124|NCT00676780|OG000|Outcome|ECGC Extract|Epigallocatechin Gallate (ECGC) Single arm for a phase II study.
10923125|NCT00676780|EG000|Reported Event|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
10923126|NCT00676793|BG000|Baseline|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
10923127|NCT00676793|FG000|Participant Flow|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
10923128|NCT00676793|OG000|Outcome|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
11175276|NCT02028676|BG004|Baseline|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923129|NCT00676793|OG000|Outcome|ECGC and Breast Cancer|The effect of ECGC extract on biomarkers in breast cancer.
10923130|NCT00676793|EG000|Reported Event|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
10923131|NCT00676806|BG000|Baseline|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
10923132|NCT00676806|BG001|Baseline|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
10923133|NCT00676806|BG002|Baseline|Total|Total of all reporting groups
10923134|NCT00676806|FG000|Participant Flow|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
10923135|NCT00676806|FG001|Participant Flow|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
11175277|NCT02028676|BG005|Baseline|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
10923136|NCT00676806|OG000|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.~2/2 evaluable subjects engrafted at +45 and +90 days."
10923137|NCT00676806|OG001|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~1/2 evaluable subjects engrafted at +45 and +90 days."
10923138|NCT00676806|OG000|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
10923139|NCT00676806|OG001|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
10923140|NCT00676806|OG000|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.~2/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity."
10923141|NCT00676806|OG001|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~1/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity."
10923142|NCT00676806|EG000|Reported Event|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
10923143|NCT00676806|EG001|Reported Event|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
10923144|NCT00676897|BG000|Baseline|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
10923145|NCT00676897|BG001|Baseline|Placebo Group|Placebo: Corn Starch
10923146|NCT00676897|BG002|Baseline|Total|Total of all reporting groups
10923147|NCT00676897|FG000|Participant Flow|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
11175278|NCT02028676|BG006|Baseline|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
11175279|NCT02028676|BG007|Baseline|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
11175280|NCT02028676|BG008|Baseline|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
11175281|NCT02028676|BG009|Baseline|Total|Total of all reporting groups
11175282|NCT02028676|FG000|Participant Flow|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
11175283|NCT02028676|FG001|Participant Flow|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
11357626|NCT03752151|OG000|Outcome|MARVEL 2 Monitor Mode Then MARVEL 2 Adaptive Mode|Participants were programmed to MARVEL 2 algorithm monitor mode which provides standard VVI pacing for approximately 20 minutes. Then the MARVEL 2 algorithm was programmed to adaptive mode which provides VDD pacing for approximately 2 hours.
10923148|NCT00676897|FG001|Participant Flow|Placebo Group|Placebo: Corn Starch
10923149|NCT00676897|OG000|Outcome|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
10923150|NCT00676897|OG001|Outcome|Placebo Group|Placebo: Corn Starch
10923151|NCT00676897|EG000|Reported Event|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
10923152|NCT00676897|EG001|Reported Event|Placebo Group|Placebo: Corn Starch
10923153|NCT00677014|BG000|Baseline|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
10923154|NCT00677014|BG001|Baseline|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
10923155|NCT00677014|BG002|Baseline|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
10923156|NCT00677014|BG003|Baseline|Total|Total of all reporting groups
10923157|NCT00677014|FG000|Participant Flow|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
10923158|NCT00677014|FG001|Participant Flow|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
10923159|NCT00677014|FG002|Participant Flow|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
10923160|NCT00677014|OG000|Outcome|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
10923161|NCT00677014|OG001|Outcome|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
10923162|NCT00677014|OG002|Outcome|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
10923163|NCT00677014|EG000|Reported Event|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
10923164|NCT00677014|EG001|Reported Event|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
10923165|NCT00677014|EG002|Reported Event|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
10923166|NCT00677040|BG000|Baseline|Subjects|patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment
10923167|NCT00677040|FG000|Participant Flow|Subjects|patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment
10923168|NCT00677040|OG000|Outcome|Subjects|patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment
10923169|NCT00677040|OG000|Outcome|Subjects|patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment. No adverse events were detected.
10923170|NCT00677040|EG000|Reported Event|Subjects|patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment. No adverse events were detected.
10923171|NCT00677092|BG000|Baseline|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
10923172|NCT00677092|FG000|Participant Flow|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if participant developed gastrointestinal intolerance or alopecia.
10923173|NCT00677092|OG000|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 milligrams (mg) orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
10923174|NCT00677092|OG000|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
10923175|NCT00677092|EG000|Reported Event|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
10923176|NCT00677235|BG000|Baseline|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
10923177|NCT00677235|BG001|Baseline|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
10923178|NCT00677235|BG002|Baseline|Total|Total of all reporting groups
10923179|NCT00677235|FG000|Participant Flow|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
10923180|NCT00677235|FG001|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty (PTA): Treatment of stenoses with PTA only
10923181|NCT00677235|OG000|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
10923182|NCT00677235|OG001|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
10923183|NCT00677235|EG000|Reported Event|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
10923184|NCT00677235|EG001|Reported Event|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
10923185|NCT00677352|BG000|Baseline|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
10923186|NCT00677352|BG001|Baseline|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
10923187|NCT00677352|BG002|Baseline|Total|Total of all reporting groups
10923188|NCT00677352|FG000|Participant Flow|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
10923189|NCT00677352|FG001|Participant Flow|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
10923190|NCT00677352|OG000|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
10964058|NCT00875641|BG002|Baseline|Recent Historical Control Cohort|Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
10923191|NCT00677352|OG001|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
10923192|NCT00677352|EG000|Reported Event|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
10923193|NCT00677352|EG001|Reported Event|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
10963212|NCT00870870|FG001|Participant Flow|GCC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cixutumumab: 6 milligrams per kilogram (mg/kg) intravenous (IV) infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963213|NCT00870870|FG002|Participant Flow|Gemcitabine/Cisplatin/Cetuximab (GCiC)|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963214|NCT00870870|FG003|Participant Flow|GCiC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963215|NCT00870870|OG000|Outcome|Gemcitabine/Cisplatin/Cetuximab (GCiC)|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963216|NCT00870870|OG001|Outcome|GCiC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963217|NCT00870870|OG000|Outcome|GCiC|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963218|NCT00870870|OG000|Outcome|Gemcitabine/Carboplatin/Cetuximab (GCC)|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10964059|NCT00875641|BG003|Baseline|Total|Total of all reporting groups
11234122|NCT02432235|OG000|Outcome|Dose-Limiting Toxicity (DLT) Evaluable Set Analysis Set|DLT Evaluable Analysis Set: The DLT-evaluable analysis set consisted of participants who completed two cycles of ADCT-301 if enrolled prior to protocol amendment 4 and participants who completed one cycle of ADCT-301 if enrolled after protocol amendment 4. The participants with completed DLT information were included even if they discontinued early before the end of cycle 2 or cycle 1 respectively.
10923194|NCT00677365|BG000|Baseline|Placebo|Placebo Group
10923195|NCT00677365|BG001|Baseline|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
10923196|NCT00677365|BG002|Baseline|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
10923197|NCT00677365|BG003|Baseline|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
10923198|NCT00677365|BG004|Baseline|Total|Total of all reporting groups
10923199|NCT00677365|FG000|Participant Flow|Placebo|Placebo Group
10923200|NCT00677365|FG001|Participant Flow|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
10923201|NCT00677365|FG002|Participant Flow|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
10923202|NCT00677365|FG003|Participant Flow|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
10923203|NCT00677365|OG000|Outcome|Placebo|Placebo Group
10923204|NCT00677365|OG001|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
10923205|NCT00677365|OG002|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
10923206|NCT00677365|OG003|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
10923207|NCT00677365|EG000|Reported Event|Placebo|Placebo Group
10923208|NCT00677365|EG001|Reported Event|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
10923209|NCT00677365|EG002|Reported Event|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
10923210|NCT00677365|EG003|Reported Event|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
10923211|NCT00677534|BG000|Baseline|Cholecalciferol 50,000 U|Vitamin D
10923212|NCT00677534|FG000|Participant Flow|Cholecalciferol 50,000 U|Vitamin D
10923213|NCT00677534|OG000|Outcome|Cholecalciferol 50,000 U|Vitamin D
10923214|NCT00677534|EG000|Reported Event|Cholecalciferol 50,000 U|Vitamin D
10923215|NCT00677690|BG000|Baseline|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
10923216|NCT00677690|BG001|Baseline|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
10923217|NCT00677690|BG002|Baseline|Total|Total of all reporting groups
10923218|NCT00677690|FG000|Participant Flow|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
10923219|NCT00677690|FG001|Participant Flow|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
10923220|NCT00677690|OG000|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
10923221|NCT00677690|OG001|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
10923222|NCT00677690|EG000|Reported Event|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
10923223|NCT00677690|EG001|Reported Event|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
10923224|NCT00677807|BG000|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923225|NCT00677807|BG001|Baseline|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923226|NCT00677807|BG002|Baseline|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923227|NCT00677807|BG003|Baseline|Total|Total of all reporting groups
10923228|NCT00677807|FG000|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923229|NCT00677807|FG001|Participant Flow|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923230|NCT00677807|FG002|Participant Flow|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923231|NCT00677807|OG000|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923232|NCT00677807|OG001|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923233|NCT00677807|OG002|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923234|NCT00677807|EG000|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923235|NCT00677807|EG001|Reported Event|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923236|NCT00677807|EG002|Reported Event|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
10923237|NCT00677820|BG000|Baseline|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
10923238|NCT00677820|BG001|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
10923239|NCT00677820|BG002|Baseline|Total|Total of all reporting groups
10923240|NCT00677820|FG000|Participant Flow|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
10923241|NCT00677820|FG001|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
10923242|NCT00677820|OG000|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
10923243|NCT00677820|OG001|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
10923244|NCT00677820|EG000|Reported Event|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
10923245|NCT00677820|EG001|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
10923246|NCT00677833|BG000|Baseline|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between >=5 years of age and <=12 years of age.
11175284|NCT02028676|FG002|Participant Flow|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
11191995|NCT02135861|FG000|Participant Flow|Healthy Volunteers|Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923247|NCT00677833|BG001|Baseline|Cohort 1: Artemether + Lumefantrine|"Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2.~Cohort 1 included participants between >=5 years of age and <=12 years of age."
10923248|NCT00677833|BG002|Baseline|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
10923249|NCT00677833|BG003|Baseline|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
10923250|NCT00677833|BG004|Baseline|Total|Total of all reporting groups
10923251|NCT00677833|FG000|Participant Flow|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (>=) 5 years of age and less than or equal to (<=) 12 years of age.
10923252|NCT00677833|FG001|Participant Flow|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
10923253|NCT00677833|FG002|Participant Flow|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
10923254|NCT00677833|FG003|Participant Flow|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
10964060|NCT00875641|FG000|Participant Flow|HRV Cohort|HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).
10923255|NCT00677833|OG000|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
10923256|NCT00677833|OG001|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
10923257|NCT00677833|EG000|Reported Event|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between >=5 years of age and <=12 years of age.
10923258|NCT00677833|EG001|Reported Event|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
10923259|NCT00677833|EG002|Reported Event|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
10923260|NCT00677833|EG003|Reported Event|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
10923261|NCT00677898|BG000|Baseline|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
10923262|NCT00677898|BG001|Baseline|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
10923263|NCT00677898|BG002|Baseline|Total|Total of all reporting groups
10923264|NCT00677898|FG000|Participant Flow|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
10923265|NCT00677898|FG001|Participant Flow|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
11191996|NCT02135861|FG001|Participant Flow|Heart Failure Participants|Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923266|NCT00677898|OG000|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
10923267|NCT00677898|OG001|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
10923268|NCT00677898|EG000|Reported Event|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
10923269|NCT00677898|EG001|Reported Event|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
10923270|NCT00677924|BG000|Baseline|Zalatumumab 8 mg/kg|
10923271|NCT00677924|BG001|Baseline|Zalutumumab 16 mg/kg|
10923272|NCT00677924|BG002|Baseline|Total|Total of all reporting groups
10923273|NCT00677924|FG000|Participant Flow|Zalatumumab 8 mg/kg|
10923274|NCT00677924|FG001|Participant Flow|Zalutumumab 16 mg/kg|
10923275|NCT00677924|OG000|Outcome|Zalatumumab 8 mg/kg|
10923276|NCT00677924|OG001|Outcome|Zalutumumab 16 mg/kg|
10923277|NCT00677924|EG000|Reported Event|Zalatumumab 8 mg/kg|
10923278|NCT00677924|EG001|Reported Event|Zalutumumab 16 mg/kg|
10923279|NCT00678015|BG000|Baseline|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
10923280|NCT00678015|FG000|Participant Flow|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
10923281|NCT00678015|OG000|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
10923282|NCT00678015|EG000|Reported Event|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
10923283|NCT00678080|BG000|Baseline|Metformin|"Metformin therapy~Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily"
10923284|NCT00678080|BG001|Baseline|Insulin|"Insulin~Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day"
10923285|NCT00678080|BG002|Baseline|Total|Total of all reporting groups
10923286|NCT00678080|FG000|Participant Flow|Metformin|"Metformin therapy~Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily"
10923287|NCT00678080|FG001|Participant Flow|Insulin|"Insulin~Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day"
10923288|NCT00678080|OG000|Outcome|Metformin|"Metformin therapy~Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily"
10923289|NCT00678080|OG001|Outcome|Insulin|"Insulin~Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day"
10923290|NCT00678080|EG000|Reported Event|Metformin|"Metformin therapy~Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily"
10923291|NCT00678080|EG001|Reported Event|Insulin|"Insulin~Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day"
10923292|NCT00678210|BG000|Baseline|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
10923293|NCT00678210|BG001|Baseline|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
10923294|NCT00678210|BG002|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
10923295|NCT00678210|BG003|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
11191997|NCT02135861|FG002|Participant Flow|Acute Decompensated Heart Failure Participants|Acute Decompensated Heart Failure participants following hospitalization due to pulmonary oedema was placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923296|NCT00678210|BG004|Baseline|Total|Total of all reporting groups
10923297|NCT00678210|FG000|Participant Flow|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 milligram (mg) orally twice daily for 12 weeks.
10923298|NCT00678210|FG001|Participant Flow|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
10923299|NCT00678210|FG002|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
10923300|NCT00678210|FG003|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
10923301|NCT00678210|OG000|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
10923302|NCT00678210|OG001|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
10923303|NCT00678210|OG002|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
10923304|NCT00678210|OG003|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
10923305|NCT00678210|EG000|Reported Event|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
10923306|NCT00678210|EG001|Reported Event|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
10923307|NCT00678210|EG002|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
10923308|NCT00678210|EG003|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
10923309|NCT00678249|BG000|Baseline|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
10923310|NCT00678249|BG001|Baseline|PTA Only|Percutaneous Transluminal Angioplasty
10923311|NCT00678249|BG002|Baseline|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
10923312|NCT00678249|BG003|Baseline|Total|Total of all reporting groups
10923313|NCT00678249|FG000|Participant Flow|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
10923314|NCT00678249|FG001|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty
10923315|NCT00678249|FG002|Participant Flow|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
10923316|NCT00678249|OG000|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
10923317|NCT00678249|OG001|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
10923318|NCT00678249|OG002|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
10923319|NCT00678249|EG000|Reported Event|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
10923320|NCT00678249|EG001|Reported Event|PTA Only|Percutaneous Transluminal Angioplasty
10923321|NCT00678249|EG002|Reported Event|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
10923322|NCT00678301|BG000|Baseline|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
10923323|NCT00678301|BG001|Baseline|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
10923324|NCT00678301|BG002|Baseline|Total|Total of all reporting groups
11234123|NCT02432235|OG000|Outcome|Efficacy Analysis Set|Participants received an intravenous (IV) infusion of camidanlumab tesirine at any dose (doses ranging from 3 μg/kg to 300 μg/kg) on Day 1 of each 3-week treatment cycle. The maximum number of cycles received was 15.
10923325|NCT00678301|FG000|Participant Flow|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
10923326|NCT00678301|FG001|Participant Flow|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
10923327|NCT00678301|OG000|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
10923328|NCT00678301|OG001|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
10923329|NCT00678301|EG000|Reported Event|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
10923330|NCT00678301|EG001|Reported Event|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
10923331|NCT00678379|BG000|Baseline|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
10923332|NCT00678379|BG001|Baseline|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
10923333|NCT00678379|BG002|Baseline|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
10923334|NCT00678379|BG003|Baseline|Total|Total of all reporting groups
10923335|NCT00678379|FG000|Participant Flow|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
10923336|NCT00678379|FG001|Participant Flow|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
10923337|NCT00678379|FG002|Participant Flow|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
10923338|NCT00678379|OG000|Outcome|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
10923339|NCT00678379|OG001|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
10923340|NCT00678379|OG002|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
10923341|NCT00678379|EG000|Reported Event|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
10923342|NCT00678379|EG001|Reported Event|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
10923343|NCT00678379|EG002|Reported Event|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
10923344|NCT00678392|BG000|Baseline|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
10923345|NCT00678392|BG001|Baseline|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
10923346|NCT00678392|BG002|Baseline|Total|Total of all reporting groups
11234124|NCT02432235|EG000|Reported Event|3 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10923347|NCT00678392|FG000|Participant Flow|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
10923348|NCT00678392|FG001|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
10923349|NCT00678392|OG000|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
10923350|NCT00678392|OG001|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
10923351|NCT00678392|EG000|Reported Event|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
10923352|NCT00678392|EG001|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
10923353|NCT00678418|BG000|Baseline|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
10923354|NCT00678418|BG001|Baseline|Placebo|Single intramuscular (IM) injection administered every 4 weeks
10923355|NCT00678418|BG002|Baseline|Total|Total of all reporting groups
10923356|NCT00678418|FG000|Participant Flow|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
11191998|NCT02135861|OG000|Outcome|Healthy Volunteers|Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
11234125|NCT02432235|EG001|Reported Event|5 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10923357|NCT00678418|FG001|Participant Flow|Placebo|Single intramuscular (IM) injection administered every 4 weeks
10923358|NCT00678418|OG000|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
10923359|NCT00678418|OG001|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
10923360|NCT00678418|EG000|Reported Event|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
10923361|NCT00678418|EG001|Reported Event|Placebo|Single intramuscular (IM) injection administered every 4 weeks
10923362|NCT00678444|BG000|Baseline|Randomized to Not Watch Educational Video|Randomized to not watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
10923363|NCT00678444|BG001|Baseline|Randomized to Watch Pre-operative Educational Video About Clea|Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
10923364|NCT00678444|BG002|Baseline|Total|Total of all reporting groups
10923365|NCT00678444|FG000|Participant Flow|Arm 1: Non-educational Video Self-catheterization|Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery
10923366|NCT00678444|FG001|Participant Flow|Arm 2: Educational Video Self-catheterization Group|Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
10923367|NCT00678444|OG000|Outcome|Arm 1: Education Without Video Tutorial|Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery
10923368|NCT00678444|OG001|Outcome|Randomized to Watch Educational Video About Clean Intermittent|Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
10923369|NCT00678444|EG000|Reported Event|Arm 1: Non-educational Video Self-catheterization Group|Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery
10923370|NCT00678444|EG001|Reported Event|Arm 2: Educational Video Self-catheterization Group|Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
10923371|NCT00678470|BG000|Baseline|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
10923372|NCT00678470|FG000|Participant Flow|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
10923373|NCT00678470|OG000|Outcome|Single Arm|"Investigational intervention without random assignment~Intralesional Alefacept: Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks."
10923374|NCT00678470|EG000|Reported Event|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
10923375|NCT00678496|BG000|Baseline|CBT Software|CBT using 'Beating the Blues'® software (Ultrasis Ltd). Beating the Blues® consists of eight computer-interactive sessions, of approximately 50 minutes each in duration, designed to be taken weekly. Each session consists of a mix of cognitive and behavioural strategies, which the user customises to their individual problems.
10923376|NCT00678496|BG001|Baseline|Treatment as Usual|Treatment as usual. The research protocol did not manualise or restrict treatment as usual, but a client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
10923377|NCT00678496|BG002|Baseline|Total|Total of all reporting groups
10923378|NCT00678496|FG000|Participant Flow|Computerised CBT Using 'Beating the Blues'® (Ultrasis Ltd)|CBT software (n=12). Beating the Blues® consists of eight computer-interactive sessions, of approximately 50 minutes each in duration, designed to be taken weekly.
10923379|NCT00678496|FG001|Participant Flow|Treatment as Usual|Treatment as usual (n=12). The research protocol did not manualise or restrict treatment as usual, but a client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
10923380|NCT00678496|OG000|Outcome|CCBT|Ultrasis - Beating the Blues® is a computer-interactive programme for the treatment of anxiety and depression. It is based on cognitive behavioural therapy (CBT), which helps patients to identify and change unhelpful ways of thinking and to learn more effective ways of solving problems.
10923381|NCT00678496|OG001|Outcome|Treatment as Usual|The research protocol did not manualise or restrict treatment as usual. A client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
10923382|NCT00678496|OG000|Outcome|CCBT|CCBT using 'Beating the Blues'® (Ultrasis Ltd). Beating the Blues® consists of eight computer-interactive sessions, of approximately 50 minutes each in duration, designed to be taken weekly. Each session consists of a mix of cognitive and behavioural strategies, which the user customises to their individual problems.
10923383|NCT00678496|OG001|Outcome|Treatment as Usual|Treatment as usual. The research protocol did not manualise or restrict treatment as usual, but a client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
10923384|NCT00678496|EG000|Reported Event|CCBT Using 'Beating the Blues'® (Ultrasis Ltd)|CBT software (n=12). Beating the Blues® consists of eight computer-interactive sessions, of approximately 50 minutes each in duration, designed to be taken weekly.
10923385|NCT00678496|EG001|Reported Event|Treatment as Usual|Treatment as usual (n=12). The research protocol did not manualise or restrict treatment as usual, but a client service receipt inventory was used at baseline, 8 weeks and 21 weeks to identify concomitant medication and service use in both arms.
10923386|NCT00678535|BG000|Baseline|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
10923387|NCT00678535|BG001|Baseline|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
10923388|NCT00678535|BG002|Baseline|Total|Total of all reporting groups
10923389|NCT00678535|FG000|Participant Flow|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
10923390|NCT00678535|FG001|Participant Flow|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
10923391|NCT00678535|OG000|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
10923392|NCT00678535|OG001|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
10923393|NCT00678535|EG000|Reported Event|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
10923394|NCT00678535|EG001|Reported Event|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
10923395|NCT00678561|BG000|Baseline|2% CP-690,550 Once Daily|CP-690,550 2.0 percent (%) (50 microgram per square centimeter [mcg/cm^2]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
11175285|NCT02028676|FG003|Participant Flow|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923396|NCT00678561|BG001|Baseline|0.2% CP-690,550 Once Daily|CP-690,550 0.2% (5 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923397|NCT00678561|BG002|Baseline|0.02% CP-690,550 Once Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923398|NCT00678561|BG003|Baseline|Placebo Once Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.
10923399|NCT00678561|BG004|Baseline|2% CP-690,550 Twice Daily|CP-690,550 2.0% (50 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923400|NCT00678561|BG005|Baseline|0.2% CP-690,550 Twice Daily|CP-690,550 0.2% (5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923401|NCT00678561|BG006|Baseline|0.02% CP-690,550 Twice Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923402|NCT00678561|BG007|Baseline|Placebo Twice Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.
10923403|NCT00678561|BG008|Baseline|Total|Total of all reporting groups
10923404|NCT00678561|FG000|Participant Flow|2% CP-690,550 Once Daily|CP-690,550 2.0 percent (%) (50 microgram per square centimeter [mcg/cm^2]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923405|NCT00678561|FG001|Participant Flow|0.2% CP-690,550 Once Daily|CP-690,550 0.2% (5 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923406|NCT00678561|FG002|Participant Flow|0.02% CP-690,550 Once Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923407|NCT00678561|FG003|Participant Flow|Placebo Once Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.
10923408|NCT00678561|FG004|Participant Flow|2% CP-690,550 Twice Daily|CP-690,550 2.0% (50 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923409|NCT00678561|FG005|Participant Flow|0.2% CP-690,550 Twice Daily|CP-690,550 0.2% (5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923410|NCT00678561|FG006|Participant Flow|0.02% CP-690,550 Twice Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923411|NCT00678561|FG007|Participant Flow|Placebo Twice Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.
10923412|NCT00678561|OG000|Outcome|2% CP-690,550 Once Daily|CP-690,550 2.0 percent (%) (50 microgram per square centimeter [mcg/cm^2]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923413|NCT00678561|OG001|Outcome|0.2% CP-690,550 Once Daily|CP-690,550 0.2% (5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923414|NCT00678561|OG002|Outcome|0.02% CP-690,550 Once Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923415|NCT00678561|OG003|Outcome|Placebo Once Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas once daily up to Day 28.
10923416|NCT00678561|OG004|Outcome|2% CP-690,550 Twice Daily|CP-690,550 2.0% (50 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923417|NCT00678561|OG005|Outcome|0.2% CP-690,550 Twice Daily|CP-690,550 0.2% (5 mcg/cm^2) gel applied topically on 1 target plaque area, along with matching placebo gel on another target plaque area, twice daily up to Day 28.
10923418|NCT00678561|OG006|Outcome|0.02% CP-690,550 Twice Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923419|NCT00678561|OG007|Outcome|Placebo Twice Daily|Matching placebo gel applied topically on 2 target plaque areas twice daily up to Day 28.
10923420|NCT00678561|OG001|Outcome|0.2% CP-690,550 Once Daily|CP-690,550 0.2% (5 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923421|NCT00678561|OG003|Outcome|Placebo Once Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.
10923422|NCT00678561|OG005|Outcome|0.2% CP-690,550 Twice Daily|CP-690,550 0.2% (5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923423|NCT00678561|OG007|Outcome|Placebo Twice Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.
10923424|NCT00678561|OG000|Outcome|2% CP-690,550 Twice Daily|CP-690,550 2.0% (50 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923425|NCT00678561|OG001|Outcome|0.2% CP-690,550 Twice Daily|CP-690,550 0.2% (5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923426|NCT00678561|OG002|Outcome|0.02% CP-690,550 Twice Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923427|NCT00678561|EG000|Reported Event|2% CP-690,550 Once Daily|CP-690,550 2.0 percent (%) (50 microgram per square centimeter [mcg/cm^2]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923428|NCT00678561|EG001|Reported Event|0.2% CP-690,550 Once Daily|CP-690,550 0.2% (5 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923429|NCT00678561|EG002|Reported Event|0.02% CP-690,550 Once Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.
10923430|NCT00678561|EG003|Reported Event|Placebo Once Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.
10923431|NCT00678561|EG004|Reported Event|2% CP-690,550 Twice Daily|CP-690,550 2.0% (50 mcg/cm^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923432|NCT00678561|EG005|Reported Event|0.2% CP-690,550 Twice Daily|CP-690,550 0.2% (5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923433|NCT00678561|EG006|Reported Event|0.02% CP-690,550 Twice Daily|CP-690,550 0.02% (0.5 mcg/cm^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.
10923434|NCT00678561|EG007|Reported Event|Placebo Twice Daily|CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.
10923435|NCT00678587|BG000|Baseline|Placebo|Matching placebo
10923436|NCT00678587|BG001|Baseline|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
11175286|NCT02028676|FG004|Participant Flow|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
11175287|NCT02028676|FG005|Participant Flow|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
11175288|NCT02028676|FG006|Participant Flow|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
11175289|NCT02028676|FG007|Participant Flow|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
11175290|NCT02028676|FG008|Participant Flow|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
11191999|NCT02135861|OG001|Outcome|Heart Failure Participants|Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923437|NCT00678587|BG002|Baseline|Total|Total of all reporting groups
10923438|NCT00678587|FG000|Participant Flow|Placebo|Matching placebo
10923439|NCT00678587|FG001|Participant Flow|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
10923440|NCT00678587|OG000|Outcome|Placebo|Matching placebo
10923441|NCT00678587|OG001|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
10923442|NCT00678587|OG000|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
10923443|NCT00678587|EG000|Reported Event|Placebo|Matching placebo
10923444|NCT00678587|EG001|Reported Event|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
10923445|NCT00678639|BG000|Baseline|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
10923446|NCT00678639|BG001|Baseline|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
10923447|NCT00678639|BG002|Baseline|Total|Total of all reporting groups
10923448|NCT00678639|FG000|Participant Flow|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
10923449|NCT00678639|FG001|Participant Flow|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
10923450|NCT00678639|OG000|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
10923451|NCT00678639|OG001|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
10923452|NCT00678639|OG000|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit- Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
10923453|NCT00678639|EG000|Reported Event|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
10923454|NCT00678639|EG001|Reported Event|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
10923455|NCT00678652|BG000|Baseline|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923456|NCT00678652|BG001|Baseline|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923457|NCT00678652|BG002|Baseline|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923458|NCT00678652|BG003|Baseline|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923459|NCT00678652|BG004|Baseline|Total|Total of all reporting groups
11175291|NCT02028676|OG000|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
11175292|NCT02028676|OG001|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
11175293|NCT02028676|OG000|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
11175294|NCT02028676|OG001|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
11175295|NCT02028676|OG002|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
11192000|NCT02135861|OG000|Outcome|Heart Failure Participants|Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923460|NCT00678652|FG000|Participant Flow|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923461|NCT00678652|FG001|Participant Flow|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923462|NCT00678652|FG002|Participant Flow|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923463|NCT00678652|FG003|Participant Flow|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923464|NCT00678652|OG000|Outcome|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923465|NCT00678652|OG001|Outcome|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
11175296|NCT02028676|OG002|Outcome|ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
11175297|NCT02028676|OG000|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
10923466|NCT00678652|OG002|Outcome|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923467|NCT00678652|OG003|Outcome|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923468|NCT00678652|EG000|Reported Event|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923469|NCT00678652|EG001|Reported Event|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923470|NCT00678652|EG002|Reported Event|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923471|NCT00678652|EG003|Reported Event|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
10923472|NCT00678691|BG000|Baseline|A,1 Armodafinil Study Drug|armodafinil
10923473|NCT00678691|BG001|Baseline|A,2 Matching Placebo|placebo
10923474|NCT00678691|BG002|Baseline|Total|Total of all reporting groups
10923475|NCT00678691|FG000|Participant Flow|A,1 Armodafinil Study Drug 50-250mg Flexible Dose|armodafinil
11175298|NCT02028676|OG001|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
10923476|NCT00678691|FG001|Participant Flow|A,2 Matching Placebo|placebo
10923477|NCT00678691|OG000|Outcome|A,1 Armodafinil Study Drug|armodafinil
10923478|NCT00678691|OG001|Outcome|A,2 Matching Placebo|placebo
10923479|NCT00678691|EG000|Reported Event|A,1 Armodafinil Study Drug|armodafinil
10923480|NCT00678691|EG001|Reported Event|A,2 Matching Placebo|placebo
10923481|NCT00678795|BG000|Baseline|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
10923482|NCT00678795|BG001|Baseline|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
10923483|NCT00678795|BG002|Baseline|Total|Total of all reporting groups
10923484|NCT00678795|FG000|Participant Flow|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
10923485|NCT00678795|FG001|Participant Flow|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
10923486|NCT00678795|OG000|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
10923487|NCT00678795|OG001|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
10923488|NCT00678795|EG000|Reported Event|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
10923489|NCT00678795|EG001|Reported Event|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
10923490|NCT00678834|BG000|Baseline|Arm 1- Surgical + Tocotrienol 200 mg|Surgical Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
10923491|NCT00678834|BG001|Baseline|Arm 2 - Surgical + Tocopherol 200 mg|Surgical Subjects will recieve Tocopherol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
10923492|NCT00678834|BG002|Baseline|Arm 3- Healthy + Tocotrienol 200 mg|Healthy Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
10923493|NCT00678834|BG003|Baseline|Total|Total of all reporting groups
10923494|NCT00678834|FG000|Participant Flow|Arm 1- Surgery + Tocotrienol 200 mg|Surgery Patients to take Tocotrienol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
10923495|NCT00678834|FG001|Participant Flow|Arm 2- Surgery + Tocopherol 200 mg|Surgery Patients to take Tocopherol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
10923496|NCT00678834|FG002|Participant Flow|Arm 3- Healthy +Tocotrienol 400 mg|Healthy patients to take Tocotrienol: 400 mg to take orally (two 200 mg capsules) two times a day.
10923497|NCT00678834|OG000|Outcome|Arm 1: Surgical, Adipose|adipose aTE levels after supplementation (400mg/d)
10923498|NCT00678834|OG001|Outcome|Arm 1: Surgical, Brain|brain aTE levels after supplementation (400mg/d)
10923499|NCT00678834|OG002|Outcome|Arm 1: Surgical, Heart|heart aTE levels after supplementation (400mg/d)
10923500|NCT00678834|OG003|Outcome|Arm 1: Surgical, Liver|liver aTE levels after supplementation (400mg/d)
10923501|NCT00678834|OG004|Outcome|Arm 2: Surgical, Adipose|adipose aTCP levels after supplementation (400mg/d)
10923502|NCT00678834|OG005|Outcome|Arm 2: Surgical, Brain|brain aTCP levels after supplementation (400mg/d)
10923503|NCT00678834|OG006|Outcome|Arm 2: Surgical, Heart|heart aTCP levels after supplementation (400mg/d)
10923504|NCT00678834|OG007|Outcome|Arm 2: Surgical, Liver|liver aTCP levels after supplementation (400mg/d)
10923505|NCT00678834|OG008|Outcome|Arm 3: Healthy, Blood, Week 0|Baseline blood levels of aTE prior to supplementation
10923506|NCT00678834|OG009|Outcome|Arm 3: Healthy, Blood, Week 6|Blood levels of aTE after 6 weeks of supplementation (400mg/d)
10923507|NCT00678834|OG010|Outcome|Arm 3: Healthy, Skin, Week 12|skin levels of aTE after 12 weeks of supplementation (400mg/d)
10923508|NCT00678834|OG011|Outcome|Arm 3: Healthy, Skin, Week 0|baseline skin levels of aTE prior to supplementation
10923509|NCT00678834|OG012|Outcome|Arm 3: Healthy, Blood, Week 12|Blood levels of aTE after 12 weeks of supplementation (400mg/d)
10923510|NCT00678834|EG000|Reported Event|Arm 1|Surgery patients to take Tocotrienol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
10923511|NCT00678834|EG001|Reported Event|Arm 2|Surgery patients to take Tocopherol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
10923512|NCT00678834|EG002|Reported Event|Arm 3|Healthy patients to take either Tocotrienol or Tocopherol: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
10923513|NCT00678886|BG000|Baseline|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
10923514|NCT00678886|BG001|Baseline|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
10923515|NCT00678886|BG002|Baseline|Total|Total of all reporting groups
10923516|NCT00678886|FG000|Participant Flow|Adolescent (Placebo)|Eligible adolescent participants received matching placebo to Otelixizumab administered as intravenous (IV) infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
10923517|NCT00678886|FG001|Participant Flow|Adolescent (Otelixizumab)|Eligible adolescent participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 milligram [mg], second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
10923518|NCT00678886|FG002|Participant Flow|Adult (Placebo)|Eligible adult participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive Days. Participants were followed-up for 24 months after the last dose.
11175299|NCT02028676|OG000|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
11175300|NCT02028676|OG001|Outcome|Stopped Cotrimoxazole Prophylaxis|
11175301|NCT02028676|OG002|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923519|NCT00678886|FG003|Participant Flow|Adult (Otelixizumab)|Eligible adult participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg), second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
10923520|NCT00678886|OG000|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
10923521|NCT00678886|OG001|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
10923522|NCT00678886|OG000|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose
10923523|NCT00678886|OG000|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
10923524|NCT00678886|OG001|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions (as first dose-day 1 of 0.1 mg, second dose-day 2 of 0.2 mg, third dose-day 3 of 0.3 mg, fourth, fifth, sixth, seventh and eight dose on days 4,5,6,7,8 of 0.5 mg per day) 1 infusion per day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg.
11234126|NCT02432235|EG002|Reported Event|8 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10923525|NCT00678886|EG000|Reported Event|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
10923526|NCT00678886|EG001|Reported Event|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
10923527|NCT00678899|BG000|Baseline|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
10923528|NCT00678899|FG000|Participant Flow|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
10923529|NCT00678899|OG000|Outcome|6 Months Postactivation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
10923530|NCT00678899|OG000|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
10923531|NCT00678899|EG000|Reported Event|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
10923532|NCT00679029|BG000|Baseline|Arm I|"AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.~TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.~Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.~N=Growth factor pegfilgastrim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles."
10923533|NCT00679029|FG000|Participant Flow|Chemotherapy With Bevacizumab|"AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.~TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.~Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.~N=Growth factor pegfilgastrim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles."
10923534|NCT00679029|OG000|Outcome|Arm I|"AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.~TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.~Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.~N=Growth factor pegfilgastrim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles."
10923535|NCT00679029|EG000|Reported Event|Arm I|"AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.~TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.~Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.~N=Growth factor pegfilgastrim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles."
10923536|NCT00679042|BG000|Baseline|Treatment|"All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.~Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:~Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant"
11175302|NCT02028676|OG003|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923537|NCT00679042|FG000|Participant Flow|Treatment|"All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.~Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:~Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant"
10923538|NCT00679042|OG000|Outcome|Treatment|"All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.~Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:~Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant"
10964061|NCT00875641|FG001|Participant Flow|Concurrent Control Cohort|Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).
10923539|NCT00679042|EG000|Reported Event|Treatment|"All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.~Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:~Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant"
10923540|NCT00679055|BG000|Baseline|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
10923541|NCT00679055|BG001|Baseline|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
10923542|NCT00679055|BG002|Baseline|Total|Total of all reporting groups
10923543|NCT00679055|FG000|Participant Flow|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
10923544|NCT00679055|FG001|Participant Flow|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
10923545|NCT00679055|OG000|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
10923546|NCT00679055|OG001|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
10923547|NCT00679055|EG000|Reported Event|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
10923548|NCT00679055|EG001|Reported Event|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
10923549|NCT00679081|BG000|Baseline|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
10923550|NCT00679081|FG000|Participant Flow|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
10923551|NCT00679081|OG000|Outcome|CelTx Site|Adverse events occurring at the CelTx site
10923552|NCT00679081|OG001|Outcome|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
10923553|NCT00679081|OG002|Outcome|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
10923554|NCT00679081|EG000|Reported Event|CelTx Site|Adverse events occurring at the CelTx site
10923555|NCT00679081|EG001|Reported Event|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
10923556|NCT00679081|EG002|Reported Event|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
10923557|NCT00679172|BG000|Baseline|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
11192001|NCT02135861|OG001|Outcome|Healthy Volunteers|Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923558|NCT00679172|BG001|Baseline|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923559|NCT00679172|BG002|Baseline|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923560|NCT00679172|BG003|Baseline|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923561|NCT00679172|BG004|Baseline|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
10923562|NCT00679172|BG005|Baseline|Total|Total of all reporting groups
10923563|NCT00679172|FG000|Participant Flow|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923564|NCT00679172|FG001|Participant Flow|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923565|NCT00679172|FG002|Participant Flow|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923566|NCT00679172|FG003|Participant Flow|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923567|NCT00679172|FG004|Participant Flow|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
10923568|NCT00679172|OG000|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923569|NCT00679172|OG001|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923570|NCT00679172|OG002|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923571|NCT00679172|OG003|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923572|NCT00679172|OG004|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
10923573|NCT00679172|OG003|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC- ssaV-) ZH9.
10923574|NCT00679172|OG000|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923575|NCT00679172|OG001|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
10923576|NCT00679172|EG000|Reported Event|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923577|NCT00679172|EG001|Reported Event|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923578|NCT00679172|EG002|Reported Event|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923579|NCT00679172|EG003|Reported Event|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
10923580|NCT00679172|EG004|Reported Event|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
10923581|NCT00679211|BG000|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
10923582|NCT00679211|FG000|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
10923583|NCT00679211|OG000|Outcome|6 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
10923584|NCT00679211|OG001|Outcome|9 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
10923585|NCT00679211|OG000|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
10923586|NCT00679211|EG000|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
10923587|NCT00679263|BG000|Baseline|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
10923588|NCT00679263|BG001|Baseline|Placebo|MN-221 Placebo continuous infusion
10923589|NCT00679263|BG002|Baseline|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
10923590|NCT00679263|BG003|Baseline|Total|Total of all reporting groups
11357627|NCT03752151|EG000|Reported Event|MARVEL 2 Monitor Mode Then MARVEL 2 Adaptive Mode|Participants were programmed to MARVEL 2 algorithm monitor mode which provides standard VVI pacing for approximately 20 minutes. Then the MARVEL 2 algorithm was programmed to adaptive mode which provides VDD pacing for approximately 2 hours.
10923591|NCT00679263|FG000|Participant Flow|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
10923592|NCT00679263|FG001|Participant Flow|Placebo|MN-221 Placebo continuous infusion
10923593|NCT00679263|FG002|Participant Flow|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
10923594|NCT00679263|OG000|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
10923595|NCT00679263|OG001|Outcome|Placebo|MN-221 Placebo continuous infusion
10923596|NCT00679263|OG002|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
10923597|NCT00679263|EG000|Reported Event|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
10923598|NCT00679263|EG001|Reported Event|Placebo|MN-221 Placebo continuous infusion
10923599|NCT00679263|EG002|Reported Event|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
10923600|NCT00679289|BG000|Baseline|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923601|NCT00679289|BG001|Baseline|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923602|NCT00679289|BG002|Baseline|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923603|NCT00679289|BG003|Baseline|Total|Total of all reporting groups
10923604|NCT00679289|FG000|Participant Flow|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923605|NCT00679289|FG001|Participant Flow|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923606|NCT00679289|FG002|Participant Flow|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923607|NCT00679289|OG000|Outcome|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923608|NCT00679289|OG001|Outcome|Total|All evaluable patients in Cohorts 1, 2, and 3 combined
10923609|NCT00679289|OG000|Outcome|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923610|NCT00679289|OG001|Outcome|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923611|NCT00679289|OG002|Outcome|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923612|NCT00679289|EG000|Reported Event|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923613|NCT00679289|EG001|Reported Event|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923614|NCT00679289|EG002|Reported Event|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
10923615|NCT00679302|BG000|Baseline|Placebo Group|Maalox and bitter mixture
10923616|NCT00679302|BG001|Baseline|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
10923617|NCT00679302|BG002|Baseline|Total|Total of all reporting groups
10923618|NCT00679302|FG000|Participant Flow|Placebo Group|Maalox and bitter mixture
10923619|NCT00679302|FG001|Participant Flow|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
10923620|NCT00679302|OG000|Outcome|Placebo Group|Maalox and bitter mixture
10923621|NCT00679302|OG001|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
10923622|NCT00679302|EG000|Reported Event|Placebo Group|Maalox and bitter mixture
10923623|NCT00679302|EG001|Reported Event|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
10923624|NCT00679341|BG000|Baseline|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
10923625|NCT00679341|BG001|Baseline|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
10923626|NCT00679341|BG002|Baseline|Total|Total of all reporting groups
10923627|NCT00679341|FG000|Participant Flow|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
10923628|NCT00679341|FG001|Participant Flow|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
10923629|NCT00679341|OG000|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
10923630|NCT00679341|OG001|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
10923631|NCT00679341|OG000|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
10923632|NCT00679341|EG000|Reported Event|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
10923633|NCT00679341|EG001|Reported Event|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
10923634|NCT00679354|BG000|Baseline|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10923635|NCT00679354|FG000|Participant Flow|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10923636|NCT00679354|OG000|Outcome|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10923637|NCT00679354|OG000|Outcome|Treatment (Cilengitide)|Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10923638|NCT00679354|EG000|Reported Event|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10923639|NCT00679367|BG000|Baseline|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
10923640|NCT00679367|FG000|Participant Flow|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
10923641|NCT00679367|OG000|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
10923642|NCT00679367|OG000|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day days 1-21~melphalan: 5 mg/m2 days 1-4"
10923643|NCT00679367|EG000|Reported Event|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
10923644|NCT00679380|BG000|Baseline|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
10923645|NCT00679380|BG001|Baseline|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
10923646|NCT00679380|BG002|Baseline|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
10923647|NCT00679380|BG003|Baseline|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
10923648|NCT00679380|BG004|Baseline|Total|Total of all reporting groups
10923649|NCT00679380|FG000|Participant Flow|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
10923650|NCT00679380|FG001|Participant Flow|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
10923651|NCT00679380|FG002|Participant Flow|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
10923652|NCT00679380|FG003|Participant Flow|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
10923653|NCT00679380|OG000|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
10923654|NCT00679380|OG001|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
10923655|NCT00679380|OG002|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
10923656|NCT00679380|OG003|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
10923657|NCT00679380|EG000|Reported Event|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
10923658|NCT00679380|EG001|Reported Event|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
10923659|NCT00679380|EG002|Reported Event|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
10923660|NCT00679380|EG003|Reported Event|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
11175303|NCT02028676|OG004|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923661|NCT00679432|BG000|Baseline|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923662|NCT00679432|BG001|Baseline|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
10923663|NCT00679432|BG002|Baseline|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923664|NCT00679432|BG003|Baseline|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
11192002|NCT02135861|OG000|Outcome|Acute Decompensated Heart Failure Participants|Acute Decompensated Heart Failure participants following hospitalization due to pulmonary oedema was placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923665|NCT00679432|BG004|Baseline|Total|Total of all reporting groups
10923666|NCT00679432|FG000|Participant Flow|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923667|NCT00679432|FG001|Participant Flow|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
10923668|NCT00679432|FG002|Participant Flow|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923669|NCT00679432|FG003|Participant Flow|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
11234127|NCT02432235|EG003|Reported Event|13 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10923670|NCT00679432|OG000|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923671|NCT00679432|OG001|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
10923672|NCT00679432|OG002|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923673|NCT00679432|OG003|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923674|NCT00679432|EG000|Reported Event|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923675|NCT00679432|EG001|Reported Event|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
10923676|NCT00679432|EG002|Reported Event|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923677|NCT00679432|EG003|Reported Event|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
10923678|NCT00679549|BG000|Baseline|DEVICE|"Provided CPAP as an inpatient~CPAP Therapy: CPAP therapy is provided as an inpatient."
10923679|NCT00679549|BG001|Baseline|Control|No device provided
10923680|NCT00679549|BG002|Baseline|Total|Total of all reporting groups
10923681|NCT00679549|FG000|Participant Flow|DEVICE|"Provided CPAP as an inpatient~CPAP Therapy: CPAP therapy is provided as an inpatient."
10923682|NCT00679549|FG001|Participant Flow|Control|No device provided
10923683|NCT00679549|OG000|Outcome|DEVICE|"Provided CPAP as an inpatient~CPAP Therapy: CPAP therapy is provided as an inpatient."
10923684|NCT00679549|OG001|Outcome|Control|No device provided
10923685|NCT00679549|EG000|Reported Event|DEVICE|"Provided CPAP as an inpatient~CPAP Therapy: CPAP therapy is provided as an inpatient."
11192003|NCT02135861|EG000|Reported Event|Healthy Volunteers|Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923686|NCT00679549|EG001|Reported Event|Control|No device provided
10923687|NCT00679627|BG000|Baseline|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
10923688|NCT00679627|BG001|Baseline|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
10923689|NCT00679627|BG002|Baseline|Total|Total of all reporting groups
10923690|NCT00679627|FG000|Participant Flow|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
10923691|NCT00679627|FG001|Participant Flow|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
10923692|NCT00679627|OG000|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
10923693|NCT00679627|OG001|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
10923694|NCT00679627|EG000|Reported Event|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
10923695|NCT00679627|EG001|Reported Event|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
10923696|NCT00679913|BG000|Baseline|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
10923697|NCT00679913|BG001|Baseline|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
10923698|NCT00679913|BG002|Baseline|Total|Total of all reporting groups
10923699|NCT00679913|FG000|Participant Flow|Standard Pancreatoduodenectomy|standard pancreatoduodenectomy Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)
10923700|NCT00679913|FG001|Participant Flow|Extended Pancreatoduodenectomy|extended pancreatoduodenectomy Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.
10923701|NCT00679913|OG000|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
10923702|NCT00679913|OG001|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
10923703|NCT00679913|OG001|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized"
10923704|NCT00679913|EG000|Reported Event|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
10923705|NCT00679913|EG001|Reported Event|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized."
10923706|NCT00679939|BG000|Baseline|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
11192004|NCT02135861|EG001|Reported Event|Heart Failure Patients|Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923707|NCT00679939|BG001|Baseline|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923708|NCT00679939|BG002|Baseline|Total|Total of all reporting groups
10923709|NCT00679939|FG000|Participant Flow|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923710|NCT00679939|FG001|Participant Flow|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923711|NCT00679939|OG000|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923712|NCT00679939|OG001|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923713|NCT00679939|OG000|Outcome|Rosiglitazone|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923714|NCT00679939|OG001|Outcome|Metformin|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923715|NCT00679939|EG000|Reported Event|Rosiglitazone: DB|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4 in the 52-week Double-Blind (DB) Period.
10923716|NCT00679939|EG001|Reported Event|Metformin: DB|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4 in the 52-week DB Period.
10923717|NCT00679939|EG002|Reported Event|Rosiglitazone: MET OL|At Week 52, all participants receiving RSG in the DB Period were switched to open-label Metformin (MET) therapy for 24 weeks during the Open-label (OL) Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923718|NCT00679939|EG003|Reported Event|Metformin: MET OL|At Week 52, all participants receiving MET in the DB Period were switched to open-label MET therapy for 24 weeks during the OL Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
10923719|NCT00679952|BG000|Baseline|Closed Suction Drainage Group|closed suction drainage group (CD group)
10923720|NCT00679952|BG001|Baseline|Natural Drainage Group|natural drainage group (ND group)
10923721|NCT00679952|BG002|Baseline|Total|Total of all reporting groups
10923722|NCT00679952|FG000|Participant Flow|Closed Suction Drainage Group|closed suction drainage group (CD group)
10923723|NCT00679952|FG001|Participant Flow|Natural Drainage Group|natural drainage group (ND group)
10923724|NCT00679952|OG000|Outcome|Closed Suction Drainage Group|closed suction drainage group (CD group)
10923725|NCT00679952|OG001|Outcome|Natural Drainage Group|natural drainage group (ND group)
10923726|NCT00679952|EG000|Reported Event|Closed Suction Drainage Group|closed suction drainage group (CD group)
10923727|NCT00679952|EG001|Reported Event|Natural Drainage Group|natural drainage group (ND group)
10923728|NCT00680017|BG000|Baseline|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
10923729|NCT00680017|BG001|Baseline|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
10923730|NCT00680017|BG002|Baseline|Total|Total of all reporting groups
10923731|NCT00680017|FG000|Participant Flow|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
10923732|NCT00680017|FG001|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
10923733|NCT00680017|OG000|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
10923734|NCT00680017|OG001|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
10923735|NCT00680017|EG000|Reported Event|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
10923736|NCT00680017|EG001|Reported Event|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
10923737|NCT00680043|BG000|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10923738|NCT00680043|BG001|Baseline|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10923739|NCT00680043|BG002|Baseline|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10923740|NCT00680043|BG003|Baseline|Total|Total of all reporting groups
10923741|NCT00680043|FG000|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10923742|NCT00680043|FG001|Participant Flow|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10923743|NCT00680043|FG002|Participant Flow|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10923744|NCT00680043|OG000|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10923745|NCT00680043|OG001|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10923746|NCT00680043|OG002|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10923747|NCT00680043|EG000|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
10923748|NCT00680043|EG001|Reported Event|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10923749|NCT00680043|EG002|Reported Event|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
10923750|NCT00680056|BG000|Baseline|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
10923751|NCT00680056|BG001|Baseline|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
10923752|NCT00680056|BG002|Baseline|Total|Total of all reporting groups
10923753|NCT00680056|FG000|Participant Flow|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
10923754|NCT00680056|FG001|Participant Flow|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
10923755|NCT00680056|OG000|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
10923756|NCT00680056|OG001|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in either first intervention period or second intervention period.
10923757|NCT00680056|OG001|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
10923758|NCT00680056|EG000|Reported Event|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
10923759|NCT00680056|EG001|Reported Event|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
10923760|NCT00680121|BG000|Baseline|Control Group|Placebo; identically matched to Benfotiamine capsules
10923761|NCT00680121|BG001|Baseline|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
10923762|NCT00680121|BG002|Baseline|Total|Total of all reporting groups
10923763|NCT00680121|FG000|Participant Flow|Control Group|Placebo; identically matched to Benfotiamine capsules
10923764|NCT00680121|FG001|Participant Flow|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
10923765|NCT00680121|OG000|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
10923766|NCT00680121|OG001|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
10923767|NCT00680121|EG000|Reported Event|Control Group|Placebo; identically matched to Benfotiamine capsules
10923768|NCT00680121|EG001|Reported Event|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
10923769|NCT00680186|BG000|Baseline|Dabigatran 150 mg|bid oral
10923770|NCT00680186|BG001|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
10923771|NCT00680186|BG002|Baseline|Total|Total of all reporting groups
10923772|NCT00680186|FG000|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
10923773|NCT00680186|FG001|Participant Flow|Warfarin|PRN (as needed) to maintain an INR (international normalised ratio) of 2.0-3.0
10923774|NCT00680186|OG000|Outcome|Dabigatran 150 mg|bid oral
10923775|NCT00680186|OG001|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
10923776|NCT00680186|EG000|Reported Event|Dabigatran 150 mg|bid oral
10923777|NCT00680186|EG001|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
10923778|NCT00680225|BG000|Baseline|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
10923779|NCT00680225|FG000|Participant Flow|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
10923780|NCT00680225|OG000|Outcome|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
10923781|NCT00680225|EG000|Reported Event|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
10923782|NCT00680368|BG000|Baseline|Physician Residents and Attending Physicians|includes physician residents and attending physicians who were asked to sit through a face to face interview with a research assistant following a clinical encounter with a patient
10923783|NCT00680368|FG000|Participant Flow|Group 1|The study began with 112 responders: 75 physician residents and 37 attending physicians. Only 60 of the 75 residents had been supervised by one of the 37 participating attending physicians. Thus, 15 residents were dropped from study. Both resident and their attending physician were surveyed to report total supervision time for each of 148 clinical encounters with 143 patients. There were more clinical encounters than patients because some patients had more than one encounter. There were more physician residents than attending physicians because attending physicians may have supervised more than one resident. There were more clinical encounters than residents because a resident may be involved in more than one clinical encounter with a patient.
10923784|NCT00680368|OG000|Outcome|Physician Residents and Attending Physicians|Sample included 112, including 60 physician residents and 37 attending physicians
10923785|NCT00680368|OG000|Outcome|Physician Residents|Includes physician residents who had a supervising attending physician participating in the study, and who received a face to face interview with a research assistant
10923786|NCT00680368|OG000|Outcome|Attending Physicians|Results reported only for the 37 attending physicians in the study sample
10923787|NCT00680368|EG000|Reported Event|Group 1|Sample included 75 resident physicians. No adverse events noted.
10923788|NCT00680407|BG000|Baseline|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
10923789|NCT00680407|BG001|Baseline|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
10923790|NCT00680407|BG002|Baseline|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
10923791|NCT00680407|BG003|Baseline|Total|Total of all reporting groups
10923792|NCT00680407|FG000|Participant Flow|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
10923793|NCT00680407|FG001|Participant Flow|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
10923794|NCT00680407|FG002|Participant Flow|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
10923795|NCT00680407|OG000|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
10923796|NCT00680407|OG001|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
10923797|NCT00680407|OG002|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
10923798|NCT00680407|EG000|Reported Event|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
10923799|NCT00680407|EG001|Reported Event|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
10923800|NCT00680407|EG002|Reported Event|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
10923801|NCT00680459|BG000|Baseline|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
10923802|NCT00680459|BG001|Baseline|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
10923803|NCT00680459|BG002|Baseline|Total|Total of all reporting groups
10923804|NCT00680459|FG000|Participant Flow|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
10923805|NCT00680459|FG001|Participant Flow|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
10923806|NCT00680459|OG000|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
10923807|NCT00680459|OG001|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
10923808|NCT00680459|EG000|Reported Event|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
10923809|NCT00680459|EG001|Reported Event|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
10923810|NCT00680524|BG000|Baseline|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
10923811|NCT00680524|FG000|Participant Flow|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
10923812|NCT00680524|OG000|Outcome|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
10923813|NCT00680524|EG000|Reported Event|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
10923814|NCT00680628|BG000|Baseline|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
10923815|NCT00680628|BG001|Baseline|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
10923816|NCT00680628|BG002|Baseline|Total|Total of all reporting groups
10923817|NCT00680628|FG000|Participant Flow|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
10923818|NCT00680628|FG001|Participant Flow|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
10923819|NCT00680628|OG000|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
10923820|NCT00680628|OG001|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
11192005|NCT02135861|EG002|Reported Event|Acute Decompensated Heart Failure|Acute Decompensated Heart Failure participants following hospitalization due to pulmonary oedema was placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
10923821|NCT00680628|EG000|Reported Event|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
10923822|NCT00680628|EG001|Reported Event|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
10923823|NCT00680706|BG000|Baseline|Thiamine|Receives thiamine
10923824|NCT00680706|BG001|Baseline|Control|Receives placebo
10923825|NCT00680706|BG002|Baseline|Total|Total of all reporting groups
10923826|NCT00680706|FG000|Participant Flow|Thiamine|Receives thiamine, 100 mg intravenously at baseline (time 0-hour) and again at time 24-hour.
10923827|NCT00680706|FG001|Participant Flow|Control|Receives placebo
10923828|NCT00680706|OG000|Outcome|Control|Placebo
10923829|NCT00680706|OG001|Outcome|Thiamine|
10923830|NCT00680706|EG000|Reported Event|Thiamine|Receives thiamine
10923831|NCT00680706|EG001|Reported Event|Control|Receives placebo
10923832|NCT00680745|BG000|Baseline|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
10923833|NCT00680745|BG001|Baseline|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
10923834|NCT00680745|BG002|Baseline|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
10923835|NCT00680745|BG003|Baseline|Placebo + Glimepiride|Placebo comparator plus glimepiride
10923836|NCT00680745|BG004|Baseline|Total|Total of all reporting groups
10923837|NCT00680745|FG000|Participant Flow|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
10923838|NCT00680745|FG001|Participant Flow|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
10923839|NCT00680745|FG002|Participant Flow|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
11175304|NCT02028676|EG000|Reported Event|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
11175305|NCT02028676|EG001|Reported Event|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
11192006|NCT02135900|BG000|Baseline|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
11234128|NCT02432235|EG004|Reported Event|20 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10923840|NCT00680745|FG003|Participant Flow|Placebo + Glimepiride|Placebo comparator plus glimepiride
10923841|NCT00680745|OG000|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
10923842|NCT00680745|OG001|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
10923843|NCT00680745|OG002|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
10923844|NCT00680745|OG003|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
10923845|NCT00680745|OG002|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
10923846|NCT00680745|EG000|Reported Event|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
10923847|NCT00680745|EG001|Reported Event|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
10923848|NCT00680745|EG002|Reported Event|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
10923849|NCT00680745|EG003|Reported Event|Placebo + Glimepiride|Placebo comparator plus glimepiride
10923850|NCT00680771|BG000|Baseline|Primary Insomnia|patients meeting criteria for primary insomnia.
10923851|NCT00680771|BG001|Baseline|Good Sleepers|participants meetoing criteira for Good Sleepers
10923852|NCT00680771|BG002|Baseline|Total|Total of all reporting groups
10923853|NCT00680771|FG000|Participant Flow|Primary Insomnia|Subjects meeting criteria for primary insomnia.
10923854|NCT00680771|FG001|Participant Flow|Good Sleepers|Subjects meeting criteira for Good Sleepers
10923855|NCT00680771|OG000|Outcome|Primary Insomnia|patients meeting criteria for primary insomnia.
10923856|NCT00680771|OG001|Outcome|Good Sleepers|participants meetoing criteira for Good Sleepers
10923857|NCT00680771|EG000|Reported Event|Primary Insomnia|patients meeting criteria for primary insomnia.
10923858|NCT00680771|EG001|Reported Event|Good Sleepers|participants meetoing criteira for Good Sleepers
10923859|NCT00680797|BG000|Baseline|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
10923860|NCT00680797|BG001|Baseline|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
10923861|NCT00680797|BG002|Baseline|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
10923862|NCT00680797|BG003|Baseline|-T -E|-Testosterone, -Estrogen
10923863|NCT00680797|BG004|Baseline|Total|Total of all reporting groups
10923864|NCT00680797|FG000|Participant Flow|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
10923865|NCT00680797|FG001|Participant Flow|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
10923866|NCT00680797|FG002|Participant Flow|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
10923867|NCT00680797|FG003|Participant Flow|-T -E|-Testosterone, -Estrogen
10923868|NCT00680797|OG000|Outcome|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
10923869|NCT00680797|OG001|Outcome|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
10923870|NCT00680797|OG002|Outcome|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
10923871|NCT00680797|OG003|Outcome|-T -E|-Testosterone, -Estrogen
10923872|NCT00680797|EG000|Reported Event|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
10923873|NCT00680797|EG001|Reported Event|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
10923874|NCT00680797|EG002|Reported Event|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
10923875|NCT00680797|EG003|Reported Event|-T -E|-Testosterone, -Estrogen
10923876|NCT00680823|BG000|Baseline|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
10923877|NCT00680823|BG001|Baseline|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
10923878|NCT00680823|BG002|Baseline|Observation|Observation for 30 minutes.
10923879|NCT00680823|BG003|Baseline|Total|Total of all reporting groups
10923880|NCT00680823|FG000|Participant Flow|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
10923881|NCT00680823|FG001|Participant Flow|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
10923882|NCT00680823|FG002|Participant Flow|Observation|Observation for 30 minutes.
10923883|NCT00680823|OG000|Outcome|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
10923884|NCT00680823|OG001|Outcome|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
10923885|NCT00680823|OG002|Outcome|Observation|Observation for 30 minutes.
10923886|NCT00680823|EG000|Reported Event|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
10923887|NCT00680823|EG001|Reported Event|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
10923888|NCT00680823|EG002|Reported Event|Observation|Observation for 30 minutes.
10923889|NCT00680836|BG000|Baseline|Placebo|These patients have Irritable Bowel syndrome (IBS) and are receiving the placebo twice a day
10923890|NCT00680836|BG001|Baseline|Treatment|These patients have Irritable Bowel syndrome (IBS) and are receiving the rifaximin 550mg twice a day
10923891|NCT00680836|BG002|Baseline|Total|Total of all reporting groups
10923892|NCT00680836|FG000|Participant Flow|Placebo Group|These patients have Irritable Bowel syndrome and are receiving the placebo twice a day
10923893|NCT00680836|FG001|Participant Flow|Active Group|These patients have Irritable Bowel syndrome and are receiving rifaximin 550mg twice a day
10923894|NCT00680836|OG000|Outcome|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
10923895|NCT00680836|OG001|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
10923896|NCT00680836|OG000|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
10923897|NCT00680836|EG000|Reported Event|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
10923898|NCT00680836|EG001|Reported Event|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
10923899|NCT00680862|BG000|Baseline|Group 1|VA employees
10923900|NCT00680862|FG000|Participant Flow|Group 1|VA employees
10923901|NCT00680862|OG000|Outcome|Group 1|VA employees
10923902|NCT00680862|EG000|Reported Event|Group 1|VA employees
10923903|NCT00680914|BG000|Baseline|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
10923904|NCT00680914|BG001|Baseline|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
10923905|NCT00680914|BG002|Baseline|Total|Total of all reporting groups
10923906|NCT00680914|FG000|Participant Flow|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
10923907|NCT00680914|FG001|Participant Flow|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
10923908|NCT00680914|OG000|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
10923909|NCT00680914|OG001|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
10923910|NCT00680914|EG000|Reported Event|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
10923911|NCT00680914|EG001|Reported Event|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
10923912|NCT00680953|BG000|Baseline|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
10923913|NCT00680953|BG001|Baseline|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
10923914|NCT00680953|BG002|Baseline|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
10923915|NCT00680953|BG003|Baseline|Total|Total of all reporting groups
10923916|NCT00680953|FG000|Participant Flow|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
10923917|NCT00680953|FG001|Participant Flow|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
10923918|NCT00680953|FG002|Participant Flow|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
10923919|NCT00680953|OG000|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
10923920|NCT00680953|OG001|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
10923921|NCT00680953|OG002|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
10923922|NCT00680953|EG000|Reported Event|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
10923923|NCT00680953|EG001|Reported Event|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
10923924|NCT00680953|EG002|Reported Event|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
10923925|NCT00680992|BG000|Baseline|Cohort 1 (Denosumab 120 mg Q4W)|Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
10923926|NCT00680992|BG001|Baseline|Cohort 2 (Denosumab 120 mg Q4W)|Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
10923927|NCT00680992|BG002|Baseline|Cohort 3 (Denosumab 120 mg Q4W)|Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
10923928|NCT00680992|BG003|Baseline|Total|Total of all reporting groups
10923929|NCT00680992|FG000|Participant Flow|Cohort 1 (Denosumab 120 mg Q4W)|Participants with surgically unsalvageable disease (eg, sacral, spinal giant cell tumor of bone (GCTB), or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 milligrams (mg) subcutaneously (SC) once every 4 weeks (Q4W), starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
11175306|NCT02028676|EG002|Reported Event|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923930|NCT00680992|FG001|Participant Flow|Cohort 2 (Denosumab 120 mg Q4W)|Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
10923931|NCT00680992|FG002|Participant Flow|Cohort 3 (Denosumab 120 mg Q4W)|Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
10923932|NCT00680992|OG000|Outcome|Cohort 1 (Denosumab 120 mg Q4W)|Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
10923933|NCT00680992|OG001|Outcome|Cohort 2 (Denosumab 120 mg Q4W)|Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
10923934|NCT00680992|OG002|Outcome|Cohort 3 (Denosumab 120 mg Q4W)|Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
10923935|NCT00680992|OG000|Outcome|Cohort 2 (Denosumab 120 mg Q4W)|Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
10923936|NCT00680992|OG000|Outcome|Adolescent PK Subset (Denosumab 120 mg Q4W)|Adolescent participants enrolled in the PK substudy who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement were included in the adolescent PK analysis set. Participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
10923937|NCT00680992|OG001|Outcome|Adult PK Subset (Denosumab 120 mg Q4W)|Adult participants enrolled in the PK substudy who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement were included in the adult PK analysis set. Participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
10923938|NCT00680992|EG000|Reported Event|Denosumab 120 mg Q4W (All Cohorts)|All participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
11175307|NCT02028676|EG003|Reported Event|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923939|NCT00681031|BG000|Baseline|All Enrolled|Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
10923940|NCT00681031|FG000|Participant Flow|All Enrolled|Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
10923941|NCT00681031|OG000|Outcome|All Enrolled|Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
10923942|NCT00681031|EG000|Reported Event|V211|All enrolled participants who received vaccination
10923943|NCT00681083|BG000|Baseline|All Study Participants|All Study participants. Note: participants took part in both arms as it was a cross over trial
10923944|NCT00681083|FG000|Participant Flow|Heated Breathing Tube|Heated breathing tube (CPAP with ThermoSmart): CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
10923945|NCT00681083|FG001|Participant Flow|Non Heated Breathing Tube|Non heated breathing tube (CPAP with conventional humidification): CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
11192007|NCT02135900|FG000|Participant Flow|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
11192008|NCT02135900|OG000|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
10923946|NCT00681083|OG000|Outcome|Heated Breathing Tube|Heated breathing tube (CPAP with ThermoSmart): CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
10923947|NCT00681083|OG001|Outcome|Non Heated Breathing Tube|Non heated breathing tube (CPAP with conventional humidification): CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
10923948|NCT00681083|EG000|Reported Event|Heated Breathing Tube|Heated breathing tube (CPAP with ThermoSmart): CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
10923949|NCT00681083|EG001|Reported Event|Non Heated Breathing Tube|Non heated breathing tube (CPAP with conventional humidification): CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
10923950|NCT00681109|BG000|Baseline|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
10923951|NCT00681109|BG001|Baseline|Placebo|Artificial Tear Topical Ophthalmic Solution
10923952|NCT00681109|BG002|Baseline|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
10923953|NCT00681109|BG003|Baseline|Total|Total of all reporting groups
10923954|NCT00681109|FG000|Participant Flow|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
10923955|NCT00681109|FG001|Participant Flow|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
10923956|NCT00681109|FG002|Participant Flow|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
10923957|NCT00681109|OG000|Outcome|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
10923958|NCT00681109|OG001|Outcome|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
10923959|NCT00681109|OG002|Outcome|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
10923960|NCT00681109|OG000|Outcome|Anakinra 2.5% Topical Ophthalmic Solution|In this study, the OSDI was assessed for patients taking Anakinra (KINERET) 2.5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
10923961|NCT00681109|OG001|Outcome|Artificial Tear Topical Ophthalmic Solution|The OSDI was assessed for patients taking placebo. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
10923962|NCT00681109|OG002|Outcome|Anakinra 5% Topical Ophthalmic Solution|The OSDI was assessed for patients taking Anakinra (KINERET) 5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
10923963|NCT00681109|EG000|Reported Event|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
10923964|NCT00681109|EG001|Reported Event|Placebo|Artificial Tear Topical Ophthalmic Solution
10923965|NCT00681109|EG002|Reported Event|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
10923966|NCT00681187|BG000|Baseline|Group 1 Self or Partner First Then HCP Administration|Self or partner administration followed by HCP administration.
10923967|NCT00681187|BG001|Baseline|Group 2 HCP Then Self or Partner Administration|Administration by HCP then self or partner administration.
10923968|NCT00681187|BG002|Baseline|Total|Total of all reporting groups
10964062|NCT00875641|FG002|Participant Flow|Recent Historical Control Cohort|Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
10923969|NCT00681187|FG000|Participant Flow|Group 1 Self or Partner First Then HCP Administration|Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (HCP) at a healthcare provider facility. The training injections were followed by a self administration block of three subsequent unsupervised injections every 28th day at the subject's home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day.
10923970|NCT00681187|FG001|Participant Flow|Group 2 HCP Then Self or Partner Administration|Started with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject's home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection.
10923971|NCT00681187|OG000|Outcome|Group 1 Self or Partner First Then HCP Administration|Self or Partner Administration followed by HCP Administration.
10923972|NCT00681187|OG001|Outcome|Group 2 HCP Then Self or Partner Administration|Administration by HCP then Self or Partner Administration.
10923973|NCT00681187|OG000|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
10923974|NCT00681187|OG001|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
10923975|NCT00681187|OG002|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
10923976|NCT00681187|OG000|Outcome|Self or Partner Administration|The self or partner administration block (after the training period) included three unsupervised injections every 28th day at the subject's home.
10923977|NCT00681187|OG001|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
11175308|NCT02028676|EG004|Reported Event|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
10923978|NCT00681187|OG000|Outcome|Self or Partner Administration|The self or partner administration block (after the training) included three unsupervised injections every 28th day at the subject's home.
10923979|NCT00681187|OG000|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
10923980|NCT00681187|OG000|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
10923981|NCT00681187|OG001|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
10923982|NCT00681187|OG002|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
10923983|NCT00681187|OG003|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
10923984|NCT00681187|OG000|Outcome|Overall Study Group|One HCP from each site who enrolled participants answered the questions
10923985|NCT00681187|EG000|Reported Event|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
10923986|NCT00681187|EG001|Reported Event|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
10923987|NCT00681187|EG002|Reported Event|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
10923988|NCT00681265|BG000|Baseline|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
10923989|NCT00681265|FG000|Participant Flow|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
10923990|NCT00681265|OG000|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
10923991|NCT00681265|OG001|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
10923992|NCT00681265|EG000|Reported Event|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
10923993|NCT00681265|EG001|Reported Event|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
10923994|NCT00681291|BG000|Baseline|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
10923995|NCT00681291|BG001|Baseline|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
10923996|NCT00681291|BG002|Baseline|Total|Total of all reporting groups
10923997|NCT00681291|FG000|Participant Flow|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
10923998|NCT00681291|FG001|Participant Flow|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
11234129|NCT02432235|EG005|Reported Event|30 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234130|NCT02432235|EG006|Reported Event|45 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
10923999|NCT00681291|OG000|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
10924000|NCT00681291|OG001|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
10924001|NCT00681291|EG000|Reported Event|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
10924002|NCT00681291|EG001|Reported Event|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
10924003|NCT00681473|BG000|Baseline|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
10924004|NCT00681473|FG000|Participant Flow|Proton Radiation Therapy|Proton Radiation Therapy daily (Monday through Friday) for six weeks. This is a single arm study.
10924005|NCT00681473|OG000|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
10924006|NCT00681473|EG000|Reported Event|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
10924007|NCT00681538|BG000|Baseline|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
10924008|NCT00681538|BG001|Baseline|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
10924009|NCT00681538|BG002|Baseline|Total|Total of all reporting groups
10924010|NCT00681538|FG000|Participant Flow|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
10924011|NCT00681538|FG001|Participant Flow|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
10924012|NCT00681538|OG000|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
10924013|NCT00681538|OG001|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
10924014|NCT00681538|EG000|Reported Event|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
10924015|NCT00681538|EG001|Reported Event|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
10964063|NCT00875641|OG000|Outcome|HRV Cohort|HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).
11234131|NCT02432235|EG007|Reported Event|60 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234132|NCT02432235|EG008|Reported Event|80 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234133|NCT02432235|EG009|Reported Event|100 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234134|NCT02432235|EG010|Reported Event|150 μg/kg|"Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.~Camidanlumab tesirine: Intravenous (IV) infusion."
11234135|NCT02432235|EG011|Reported Event|300 μg/kg|"A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).~Camidanlumab tesirine: Intravenous (IV) infusion."
11240614|NCT02480764|FG000|Participant Flow|Azilsartan Medoxomil 40 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks.
10924016|NCT00681564|BG000|Baseline|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
10924017|NCT00681564|BG001|Baseline|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
10924018|NCT00681564|BG002|Baseline|Total|Total of all reporting groups
10924019|NCT00681564|FG000|Participant Flow|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
10924020|NCT00681564|FG001|Participant Flow|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
10924021|NCT00681564|OG000|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
10924022|NCT00681564|OG001|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
10924023|NCT00681564|EG000|Reported Event|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
10924024|NCT00681564|EG001|Reported Event|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
10924025|NCT00681590|BG000|Baseline|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
10924026|NCT00681590|BG001|Baseline|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
10924027|NCT00681590|BG002|Baseline|Total|Total of all reporting groups
10924028|NCT00681590|FG000|Participant Flow|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
10924029|NCT00681590|FG001|Participant Flow|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
10924030|NCT00681590|OG000|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
10924031|NCT00681590|OG001|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
10924032|NCT00681590|EG000|Reported Event|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
10924033|NCT00681590|EG001|Reported Event|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
10924034|NCT00681668|BG000|Baseline|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
10924035|NCT00681668|FG000|Participant Flow|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
10924036|NCT00681668|OG000|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
10924037|NCT00681668|EG000|Reported Event|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
10924038|NCT00681811|BG000|Baseline|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
10924039|NCT00681811|BG001|Baseline|200 U/kg|Participants received 200 U/kg of HGT1111 IV infusion every other week.
10924040|NCT00681811|BG002|Baseline|Total|Total of all reporting groups
10924041|NCT00681811|FG000|Participant Flow|100 U/kg HGT-1111|Participants received 100 units per kilogram (U/kg) of HGT1111 intravenous (IV) infusion every other week.
10924042|NCT00681811|FG001|Participant Flow|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
10924043|NCT00681811|OG000|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
10924044|NCT00681811|OG001|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
11240615|NCT02480764|FG001|Participant Flow|Azilsartan Medoxomil 80 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks.
10924045|NCT00681811|OG002|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
10924046|NCT00681811|OG003|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
10924047|NCT00681811|OG004|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
10924048|NCT00681811|OG005|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
10924049|NCT00681811|OG006|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
10924050|NCT00681811|OG007|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
10924051|NCT00681811|OG001|Outcome|200 U/Kg-HGT-1111(Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
10924052|NCT00681811|OG002|Outcome|100 U/kg- HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
10924053|NCT00681811|OG004|Outcome|100 U/kg- HGT-1111(Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
10924054|NCT00681811|OG000|Outcome|100 U/kg HGT-1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
10924055|NCT00681811|OG001|Outcome|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
10924056|NCT00681811|EG000|Reported Event|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
10924057|NCT00681811|EG001|Reported Event|200 U/kg HGT1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
10924058|NCT00681824|BG000|Baseline|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
10924059|NCT00681824|BG001|Baseline|FS VH S/D 500 S-apr (Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group only includes the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
10924060|NCT00681824|BG002|Baseline|FS VH S/D 500 S-apr (Non Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
10924061|NCT00681824|BG003|Baseline|Total|Total of all reporting groups
10924062|NCT00681824|FG000|Participant Flow|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
10924063|NCT00681824|FG001|Participant Flow|Run-in Participants: FS VH S/D 500 S-apr|One initial
10924064|NCT00681824|FG002|Participant Flow|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes.
10924065|NCT00681824|OG000|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
10924066|NCT00681824|OG001|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
10924067|NCT00681824|OG000|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
10924068|NCT00681824|OG001|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
10924069|NCT00681824|EG000|Reported Event|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
10924070|NCT00681824|EG001|Reported Event|FS VH S/D 500 S-apr|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
10924071|NCT00681863|BG000|Baseline|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
10924072|NCT00681863|FG000|Participant Flow|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
10924073|NCT00681863|OG000|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
10924074|NCT00681863|EG000|Reported Event|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
10924075|NCT00681889|BG000|Baseline|Treatment Arm|"10 Patients will receive treatment (Ranibizumab)~Ranibizumab : 10 Patients will receive treatment (Ranibizumab)"
10924076|NCT00681889|FG000|Participant Flow|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)~Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
10924077|NCT00681889|OG000|Outcome|Treatment Arm|"9 Patients will receive treatment (Ranibizumab)~Ranibizumab : 9 Patients will receive treatment (Ranibizumab)"
10924078|NCT00681889|EG000|Reported Event|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)~Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
10924079|NCT00682357|BG000|Baseline|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
10924080|NCT00682357|BG001|Baseline|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
10924081|NCT00682357|BG002|Baseline|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
10924082|NCT00682357|BG003|Baseline|Total|Total of all reporting groups
10924083|NCT00682357|FG000|Participant Flow|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
10924084|NCT00682357|FG001|Participant Flow|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
10924085|NCT00682357|FG002|Participant Flow|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
10924086|NCT00682357|OG000|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
10924087|NCT00682357|OG001|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
10924088|NCT00682357|OG002|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
10924089|NCT00682357|EG000|Reported Event|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
10924090|NCT00682357|EG001|Reported Event|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
10924091|NCT00682357|EG002|Reported Event|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
10924092|NCT00682435|BG000|Baseline|Hydromorphone|"1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later~Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
11175309|NCT02028676|EG005|Reported Event|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
10924093|NCT00682435|FG000|Participant Flow|Hydromorphone|"1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later~Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
10924094|NCT00682435|OG000|Outcome|Hydromorphone|"1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later~Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
10924095|NCT00682435|EG000|Reported Event|1 mg Hydromorphone|"1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later~Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
10924096|NCT00682448|BG000|Baseline|Metformin|"Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months.~Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months."
10924097|NCT00682448|BG001|Baseline|Placebo|"Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.~Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months."
10924098|NCT00682448|BG002|Baseline|Total|Total of all reporting groups
10924099|NCT00682448|FG000|Participant Flow|Metformin|"Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months.~Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months."
10924100|NCT00682448|FG001|Participant Flow|Placebo|"Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.~Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months."
10924101|NCT00682448|OG000|Outcome|Metformin|"Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months.~Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months."
10924102|NCT00682448|OG001|Outcome|Placebo|"Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.~Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months."
10924103|NCT00682448|EG000|Reported Event|Metformin|"Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months.~Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months."
10924104|NCT00682448|EG001|Reported Event|Placebo|"Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.~Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months."
10924105|NCT00682539|BG000|Baseline|Avastin|After a loading dose of three monthly injections of 2.5mg Avastin, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
10964064|NCT00875641|OG001|Outcome|Concurrent Control Cohort|Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).
10924106|NCT00682539|BG001|Baseline|Triamciolone|Baseline injection of 8mg intravitreally applied triamcinolone was followed by two sham injections at month 1 and 2. Sham injections were only mimicked without penetration of the ocular globe after the same pre-injection procedure. Beginning at month 3 patients were treated as needed (PRN) based on predefined morphological and functional retreatment criteria, that were reassessed monthly. Triamcinolone was injected no more than every three months intermitted by sham injections to maintain patient masking.
10924107|NCT00682539|BG002|Baseline|Lucentis|After a loading dose of three monthly injections of 0.5mg Lucentis, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
10924108|NCT00682539|BG003|Baseline|Total|Total of all reporting groups
10924109|NCT00682539|FG000|Participant Flow|Avastin|15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.
10924110|NCT00682539|FG001|Participant Flow|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
10924111|NCT00682539|FG002|Participant Flow|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.
10924112|NCT00682539|OG000|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
10924113|NCT00682539|OG001|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
10924114|NCT00682539|OG002|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
10924115|NCT00682539|EG000|Reported Event|Avastin|Patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed as needed.
10924116|NCT00682539|EG001|Reported Event|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if needed. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
10924117|NCT00682539|EG002|Reported Event|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if needed.
10924118|NCT00682565|BG000|Baseline|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924119|NCT00682565|BG001|Baseline|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924120|NCT00682565|BG002|Baseline|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924121|NCT00682565|BG003|Baseline|Total|Total of all reporting groups
10924122|NCT00682565|FG000|Participant Flow|Mid Dose CK-1827452|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
11175310|NCT02028676|EG006|Reported Event|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
10924123|NCT00682565|FG001|Participant Flow|High Dose CK-1827452|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924124|NCT00682565|FG002|Participant Flow|Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924125|NCT00682565|OG000|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924126|NCT00682565|OG001|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924127|NCT00682565|OG002|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924128|NCT00682565|EG000|Reported Event|Cohort 1 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924129|NCT00682565|EG001|Reported Event|Cohort 2 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924130|NCT00682565|EG002|Reported Event|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
10924131|NCT00682565|EG003|Reported Event|Total|All Patients
10924132|NCT00682461|BG000|Baseline|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
10924133|NCT00682461|BG001|Baseline|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
10924134|NCT00682461|BG002|Baseline|Total|Total of all reporting groups
10924135|NCT00682461|FG000|Participant Flow|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
10924136|NCT00682461|FG001|Participant Flow|Nicotine Lozenge (2.0 mg)|Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
10924137|NCT00682461|OG000|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day
10924138|NCT00682461|OG001|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
10924139|NCT00682461|OG000|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
10924140|NCT00682461|EG000|Reported Event|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
10924141|NCT00682461|EG001|Reported Event|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum of 15 per day
10924142|NCT00682617|BG000|Baseline|Waitlist Control|Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2
10924143|NCT00682617|BG001|Baseline|3 Month Exercise Program|Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
10924144|NCT00682617|BG002|Baseline|Total|Total of all reporting groups
10924145|NCT00682617|FG000|Participant Flow|Waitlist Control|Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2
10924146|NCT00682617|FG001|Participant Flow|3 Month Exercise Program|Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
10924147|NCT00682617|OG000|Outcome|Waitlist Control|Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2
10924148|NCT00682617|OG001|Outcome|3 Month Exercise Program|Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
10924149|NCT00682617|EG000|Reported Event|Waitlist Control|Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2
10924150|NCT00682617|EG001|Reported Event|3 Month Exercise Program|Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
10924151|NCT00682643|BG000|Baseline|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
10924152|NCT00682643|BG001|Baseline|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
10924153|NCT00682643|BG002|Baseline|Total|Total of all reporting groups
10924154|NCT00682643|FG000|Participant Flow|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
10924155|NCT00682643|FG001|Participant Flow|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
10924156|NCT00682643|OG000|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
10924157|NCT00682643|OG001|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
10924158|NCT00682643|OG000|Outcome|Placebo|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
10924159|NCT00682643|EG000|Reported Event|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
10924160|NCT00682643|EG001|Reported Event|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
10924161|NCT00682734|BG000|Baseline|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
10924162|NCT00682734|BG001|Baseline|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
10924163|NCT00682734|BG002|Baseline|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
10924164|NCT00682734|BG003|Baseline|Total|Total of all reporting groups
10924165|NCT00682734|FG000|Participant Flow|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous
10924166|NCT00682734|FG001|Participant Flow|Metoclopramide 20 mg Intravenous|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
10924167|NCT00682734|FG002|Participant Flow|Metoclopramide 40 mg Intravenous|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
10924168|NCT00682734|OG000|Outcome|Metoclopramide 10 mg Intravenous|Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous
10924169|NCT00682734|OG001|Outcome|Metoclopramide 20 mg|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
10924170|NCT00682734|OG002|Outcome|Metoclopramide 40 mg|Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous
10924171|NCT00682734|EG000|Reported Event|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
10924172|NCT00682734|EG001|Reported Event|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
10924173|NCT00682734|EG002|Reported Event|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
10924174|NCT00682786|BG000|Baseline|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924175|NCT00682786|BG001|Baseline|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924176|NCT00682786|BG002|Baseline|Total|Total of all reporting groups
10924177|NCT00682786|FG000|Participant Flow|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924178|NCT00682786|FG001|Participant Flow|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924179|NCT00682786|OG000|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924180|NCT00682786|OG001|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924181|NCT00682786|OG000|Outcome|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924182|NCT00682786|OG001|Outcome|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924183|NCT00682786|OG000|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924184|NCT00682786|OG001|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924185|NCT00682786|OG000|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924186|NCT00682786|OG001|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924187|NCT00682786|EG000|Reported Event|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924188|NCT00682786|EG001|Reported Event|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
10924189|NCT00682838|BG000|Baseline|Self-management|"Active Intervention~Self-management: Self-management"
10924190|NCT00682838|BG001|Baseline|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
10924191|NCT00682838|BG002|Baseline|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
10924192|NCT00682838|BG003|Baseline|Usual Care|Usual care- control group
10924193|NCT00682838|BG004|Baseline|Total|Total of all reporting groups
10924194|NCT00682838|FG000|Participant Flow|Self-Management (SM)|"Active Intervention~Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective"
10924195|NCT00682838|FG001|Participant Flow|Telemonitored Care (TC)|"Active Comparator~Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol"
10924196|NCT00682838|FG002|Participant Flow|SM + TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care~Combination of both SM + TC intervention"
10924197|NCT00682838|FG003|Participant Flow|Usual Care|Usual care- control group
10924198|NCT00682838|OG000|Outcome|Self-management|"Active Intervention~Self-management: Self-management"
10924199|NCT00682838|OG001|Outcome|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
10924200|NCT00682838|OG002|Outcome|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
10924201|NCT00682838|OG003|Outcome|Usual Care|Usual care- control group
10924202|NCT00682838|EG000|Reported Event|Self-management|"Active Intervention~Self-management: Self-management"
10924203|NCT00682838|EG001|Reported Event|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
10924204|NCT00682838|EG002|Reported Event|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
10924205|NCT00682838|EG003|Reported Event|Usual Care|Control Group
10924206|NCT00682851|BG000|Baseline|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
10924207|NCT00682851|BG001|Baseline|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
10924208|NCT00682851|BG002|Baseline|Total|Total of all reporting groups
10924209|NCT00682851|FG000|Participant Flow|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
10924210|NCT00682851|FG001|Participant Flow|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
10924211|NCT00682851|OG000|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
10924212|NCT00682851|OG001|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
10924213|NCT00682851|EG000|Reported Event|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
10924214|NCT00682851|EG001|Reported Event|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
10924215|NCT00682890|BG000|Baseline|Placebo|Placebo tablet and birth control pill daily
10924216|NCT00682890|BG001|Baseline|Metformin|metformin 2000 mg and birth control pill daily
10924217|NCT00682890|BG002|Baseline|Total|Total of all reporting groups
10924218|NCT00682890|FG000|Participant Flow|Placebo|Placebo tablet and birth control pill daily
10924219|NCT00682890|FG001|Participant Flow|Metformin|metformin 2000 mg and birth control pill daily
10924220|NCT00682890|OG000|Outcome|Placebo|Placebo tablet and birth control pill daily
10924221|NCT00682890|OG001|Outcome|Metformin|metformin 2000 mg and birth control pill daily
10924222|NCT00682890|EG000|Reported Event|Placebo|Placebo tablet and birth control pill daily
10924223|NCT00682890|EG001|Reported Event|Metformin|metformin 2000 mg and birth control pill daily
10924224|NCT00682929|BG000|Baseline|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
10924225|NCT00682929|BG001|Baseline|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
10924226|NCT00682929|BG002|Baseline|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
10924227|NCT00682929|BG003|Baseline|Total|Total of all reporting groups
10924228|NCT00682929|FG000|Participant Flow|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
10924229|NCT00682929|FG001|Participant Flow|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
10924230|NCT00682929|FG002|Participant Flow|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
10924231|NCT00682929|OG000|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
11175311|NCT02028676|EG007|Reported Event|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
10924232|NCT00682929|OG001|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
10924233|NCT00682929|OG002|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
10924234|NCT00682929|EG000|Reported Event|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
10924235|NCT00682929|EG001|Reported Event|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
10924236|NCT00682929|EG002|Reported Event|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
10924237|NCT00683020|BG000|Baseline|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
10924238|NCT00683020|BG001|Baseline|WAIT LIST Control|WAIT LIST Control: six month Wait List.
10924239|NCT00683020|BG002|Baseline|Total|Total of all reporting groups
10924240|NCT00683020|FG000|Participant Flow|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
11175312|NCT02028676|EG008|Reported Event|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
11175313|NCT02028715|BG000|Baseline|Experimental (Normal Saline)|"Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.~Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay."
11175314|NCT02028715|BG001|Baseline|Experimental (IV Acetaminophen)|"IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.~Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay."
11175315|NCT02028715|BG002|Baseline|Total|Total of all reporting groups
11175316|NCT02028715|FG000|Participant Flow|Experimental (Normal Saline)|"Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.~Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay."
11175317|NCT02028715|FG001|Participant Flow|Experimental (IV Acetaminophen)|"IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.~Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay."
10924241|NCT00683020|FG001|Participant Flow|WAIT LIST Control|WAIT LIST Control: six month Wait List.
10924242|NCT00683020|OG000|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
10924243|NCT00683020|OG001|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
10924244|NCT00683020|EG000|Reported Event|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
10924245|NCT00683020|EG001|Reported Event|WAIT LIST Control|WAIT LIST Control: six month Wait List.
10924246|NCT00683046|BG000|Baseline|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
10924247|NCT00683046|FG000|Participant Flow|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
10924248|NCT00683046|OG000|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
11192009|NCT02135900|EG000|Reported Event|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
10924249|NCT00683046|EG000|Reported Event|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
10963219|NCT00870870|OG001|Outcome|GCC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963220|NCT00870870|OG002|Outcome|Gemcitabine/Cisplatin/Cetuximab (GCiC)|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963221|NCT00870870|OG003|Outcome|GCiC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963222|NCT00870870|OG000|Outcome|GCC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963223|NCT00870870|OG001|Outcome|GCiC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycle).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg Q2W in the subsequent cycles (2-week cycle).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963224|NCT00870870|EG000|Reported Event|Gemcitabine/Carboplatin/Cetuximab (GCC)|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963225|NCT00870870|EG001|Reported Event|GCC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963226|NCT00870870|EG002|Reported Event|Gemcitabine/Cisplatin/Cetuximab (GCiC)|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10963227|NCT00870870|EG003|Reported Event|GCiC Plus Cixutumumab|"Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).~Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles).~Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).~Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met."
10964065|NCT00875641|OG002|Outcome|Recent Historical Control Cohort|Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
10924250|NCT00683085|BG000|Baseline|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
10924251|NCT00683085|FG000|Participant Flow|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
10924252|NCT00683085|OG000|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
10924253|NCT00683085|EG000|Reported Event|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
10924254|NCT00683163|BG000|Baseline|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
10924255|NCT00683163|BG001|Baseline|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
10924256|NCT00683163|BG002|Baseline|Total|Total of all reporting groups
10924257|NCT00683163|FG000|Participant Flow|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily parathyroid hormone (PTH) 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
10924258|NCT00683163|FG001|Participant Flow|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
10924259|NCT00683163|OG000|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
10924260|NCT00683163|OG001|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
10924261|NCT00683163|EG000|Reported Event|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
10924262|NCT00683163|EG001|Reported Event|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
10924263|NCT00683293|BG000|Baseline|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
10924264|NCT00683293|BG001|Baseline|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
10924265|NCT00683293|BG002|Baseline|Total|Total of all reporting groups
10924266|NCT00683293|FG000|Participant Flow|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
10924267|NCT00683293|FG001|Participant Flow|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
10924268|NCT00683293|OG000|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
10924269|NCT00683293|OG001|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
10924270|NCT00683293|EG000|Reported Event|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
10924271|NCT00683293|EG001|Reported Event|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
10924272|NCT00683332|BG000|Baseline|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
10924273|NCT00683332|FG000|Participant Flow|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
10924274|NCT00683332|OG000|Outcome|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
10924275|NCT00683332|EG000|Reported Event|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
10924276|NCT00683384|BG000|Baseline|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
10924277|NCT00683384|FG000|Participant Flow|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
10924278|NCT00683384|OG000|Outcome|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
10924279|NCT00683384|EG000|Reported Event|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
10924280|NCT00683410|BG000|Baseline|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
10924281|NCT00683410|FG000|Participant Flow|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
10924282|NCT00683410|OG000|Outcome|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
10924283|NCT00683410|EG000|Reported Event|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
11175318|NCT02028715|OG000|Outcome|Experimental (Normal Saline)|"Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.~Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay."
11175319|NCT02028715|OG001|Outcome|Experimental (IV Acetaminophen)|"IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.~Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay."
11175320|NCT02028715|EG000|Reported Event|Experimental (Normal Saline)|"Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.~Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay."
10924284|NCT00683449|BG000|Baseline|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject's signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
10924285|NCT00683449|BG001|Baseline|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
10924286|NCT00683449|BG002|Baseline|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
10924287|NCT00683449|BG003|Baseline|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
10924288|NCT00683449|BG004|Baseline|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
10924289|NCT00683449|BG005|Baseline|Total|Total of all reporting groups
10964066|NCT00875641|EG000|Reported Event|HRV Cohort|HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).
10964067|NCT00875641|EG001|Reported Event|Concurrent Control Cohort|Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).
10964068|NCT00875641|EG002|Reported Event|Recent Historical Control Cohort|Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
11175321|NCT02028715|EG001|Reported Event|Experimental (IV Acetaminophen)|"IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.~Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay."
11175322|NCT02028754|BG000|Baseline|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
11175323|NCT02028754|BG001|Baseline|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
11175324|NCT02028754|BG002|Baseline|Total|Total of all reporting groups
11175325|NCT02028754|FG000|Participant Flow|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
11175326|NCT02028754|FG001|Participant Flow|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
11175327|NCT02028754|OG000|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
11175328|NCT02028754|OG001|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
11175329|NCT02028754|EG000|Reported Event|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
11175330|NCT02028754|EG001|Reported Event|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
11175331|NCT02028767|BG000|Baseline|Fixed Dose Combination vs. Separate Tablets|12.5 mg Empagliflozin / 500mg metformin fixed dose combination vs. free combination of 2.5 mg tablet Empagliflozin, 10 mg tablet Empagliflozin and 500 mg tablet Metformin
11175332|NCT02028767|FG000|Participant Flow|Fixed Dose Combination (FDC) First, Then Separate Tablets|"Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin first,~then free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet~Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
11175333|NCT02028767|FG001|Participant Flow|Separate Tablets First, Then Fixed Dose Combination (FDC)|"free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet first,~then Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin~Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
11175334|NCT02028767|OG000|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
11175335|NCT02028767|OG001|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
11175336|NCT02028767|EG000|Reported Event|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
11175337|NCT02028767|EG001|Reported Event|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
11175338|NCT02028780|BG000|Baseline|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
11175339|NCT02028780|BG001|Baseline|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
11175340|NCT02028780|BG002|Baseline|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
11175341|NCT02028780|BG003|Baseline|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
11175342|NCT02028780|BG004|Baseline|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
11175343|NCT02028780|BG005|Baseline|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
11175344|NCT02028780|BG006|Baseline|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
11192010|NCT02136004|BG000|Baseline|Closer VSS - Diagnostic Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases.~Closer VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
11175345|NCT02028780|BG007|Baseline|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175346|NCT02028780|BG008|Baseline|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175347|NCT02028780|BG009|Baseline|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175348|NCT02028780|BG010|Baseline|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175349|NCT02028780|BG011|Baseline|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924290|NCT00683449|FG000|Participant Flow|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject's signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
10924291|NCT00683449|FG001|Participant Flow|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
10924292|NCT00683449|FG002|Participant Flow|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
10924293|NCT00683449|FG003|Participant Flow|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
11175350|NCT02028780|BG012|Baseline|Total|Total of all reporting groups
11175351|NCT02028780|FG000|Participant Flow|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
11175352|NCT02028780|FG001|Participant Flow|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
11175353|NCT02028780|FG002|Participant Flow|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
11175354|NCT02028780|FG003|Participant Flow|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
11175355|NCT02028780|FG004|Participant Flow|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
11175356|NCT02028780|FG005|Participant Flow|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
11175357|NCT02028780|FG006|Participant Flow|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
11175358|NCT02028780|FG007|Participant Flow|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924294|NCT00683449|FG004|Participant Flow|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
10924295|NCT00683449|OG000|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject's signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
10924296|NCT00683449|OG001|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
10924297|NCT00683449|OG002|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
10924298|NCT00683449|OG003|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
10924299|NCT00683449|OG004|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
10924300|NCT00683449|OG000|Outcome|MN-221 at 16.0 μg/Min for 15 Min (Total 240 μg)|The dosing scheme that consisted of a 15-minute infusion was based on PK (pharmacokinetic) modeling performed using data from the previous MN-221 studies that enrolled either healthy volunteers or subjects with stable mild to moderate asthma.
10924301|NCT00683449|OG001|Outcome|Placebo Administered Intravenously|Initial dose group received MN-221 placebo intravenously for 15 minutes. For a subsequent dose group that was scheduled for a longer intravenous infusion of the study drug, subjects received MN-221 placebo intravenously for 15 minutes followed by MN-221 intravenously for 105 minutes.
10924302|NCT00683449|OG002|Outcome|450 μg MN-221 Given i.v.|The Data Safety Monitoring Board convened and recommended that the next highest scheduled can be administered to subjects. They received MN-221 at 30 μg/minute for 15 minutes (total dose 450 μg).
10924303|NCT00683449|OG003|Outcome|1,000-1,080 μg MN-221 Given i.v. for 15 Minutes|The Data Safety Monitoring Board recommended that subjects can receive MN-221 at 16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose 1000-1080 μg).
10924304|NCT00683449|OG004|Outcome|1,995 MN-221 Administered i.v. for 15 Minutes and 25 Minutes|One subject that was randomized to receive 450 MN-221 intravenously for 15 minutes was administered 1995 micrograms. Another subject that was randomized to receive 450 micrograms for 15 minutes actually received a dose of 1995 micrograms MN-221 intravenously for 25 minutes.
10924305|NCT00683449|EG000|Reported Event|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject's signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
10924306|NCT00683449|EG001|Reported Event|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
11175359|NCT02028780|FG008|Participant Flow|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924307|NCT00683449|EG002|Reported Event|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
10924308|NCT00683449|EG003|Reported Event|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
10924309|NCT00683449|EG004|Reported Event|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
10924310|NCT00683475|BG000|Baseline|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
10924311|NCT00683475|BG001|Baseline|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
10924312|NCT00683475|BG002|Baseline|Total|Total of all reporting groups
10924313|NCT00683475|FG000|Participant Flow|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
10924314|NCT00683475|FG001|Participant Flow|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
10924315|NCT00683475|OG000|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
10924316|NCT00683475|OG001|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
11175360|NCT02028780|FG009|Participant Flow|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924317|NCT00683475|OG000|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
10924318|NCT00683475|EG000|Reported Event|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
10924319|NCT00683475|EG001|Reported Event|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
11175361|NCT02028780|FG010|Participant Flow|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11192011|NCT02136004|BG001|Baseline|Closer VSS - Interventional Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases.~Closer VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
10924320|NCT00683592|BG000|Baseline|Vilazodone (ITT Population)|Vilazodone, 40 mg
10924321|NCT00683592|BG001|Baseline|Placebo (ITT Population)|placebo to match vilazodone
10924322|NCT00683592|BG002|Baseline|Total|Total of all reporting groups
10924323|NCT00683592|FG000|Participant Flow|Vilazodone|Vilazodone titrated to 40mg. Two tablets per day.
10924324|NCT00683592|FG001|Participant Flow|Placebo|Placebo to match vilazodone. Two tablets per day.
10924325|NCT00683592|OG000|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
10924326|NCT00683592|OG001|Outcome|Placebo (ITT Population)|placebo to match vilazodone
10924327|NCT00683592|EG000|Reported Event|Vilazodone (Safety Population)|Vilazodone, 40mg
10924328|NCT00683592|EG001|Reported Event|Placebo (Safety Population)|placebo to match vilazodone
10924329|NCT00683618|BG000|Baseline|Rosuvastatin 5mg|Taken orally once daily
10924330|NCT00683618|BG001|Baseline|Rosuvastatin 10mg|Taken orally once daily
10924331|NCT00683618|BG002|Baseline|Atorvastatin 10mg|Taken orally once daily
10924332|NCT00683618|BG003|Baseline|Total|Total of all reporting groups
10924333|NCT00683618|FG000|Participant Flow|Rosuvastatin 5mg|Taken orally once daily
10924334|NCT00683618|FG001|Participant Flow|Rosuvastatin 10mg|Taken orally once daily
10924335|NCT00683618|FG002|Participant Flow|Atorvastatin 10mg|Taken orally once daily
10924336|NCT00683618|OG000|Outcome|Rosuvastatin 5mg|Taken orally once daily
10924337|NCT00683618|OG001|Outcome|Atorvastatin 10mg|Taken orally once daily
10924338|NCT00683618|OG000|Outcome|Rosuvastatin 10mg|Taken orally once daily
10924339|NCT00683618|OG001|Outcome|Rosuvastatin 10mg|Taken orally once daily
10924340|NCT00683618|OG002|Outcome|Atorvastatin 10mg|Taken orally once daily
10924341|NCT00683618|EG000|Reported Event|Rosuvastatin 5mg|Taken orally once daily
10924342|NCT00683618|EG001|Reported Event|Rosuvastatin 10mg|Taken orally once daily
10924343|NCT00683618|EG002|Reported Event|Atorvastatin 10mg|Taken orally once daily
10924344|NCT00683644|BG000|Baseline|Group 1 Zinc First|Zinc sulfate 220 mg capsules, (corresponding to 50 mg of elemental zinc) administered once a day for 4 months. Washout period of 30 days. Placebo capsules administered once a day for 4 months.
10924345|NCT00683644|BG001|Baseline|Group 2 Placebo First|Placebo capsules administered once a day for 4 months. Washout period of 30 days. Zinc sulfate 220 mg capsules, (corresponding to 50 mg of elemental zinc) administered once a day for 4 months.
10924346|NCT00683644|BG002|Baseline|Total|Total of all reporting groups
10924347|NCT00683644|FG000|Participant Flow|Group 1 Zinc First|Zinc sulfate (50 mg elemental zinc) taken once daily for 4 months ZINC 4 MONTHS WASHOUT 1 MONTH PLACEBO 4 MONTHS
10924348|NCT00683644|FG001|Participant Flow|Group 2 Placebo First|"Placebo capsules taken once a day for 4 months~PLACEBO 4 MONTHS WASHOUT 1 MONTH ZINC 4 MONTHS"
11175362|NCT02028780|FG011|Participant Flow|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175363|NCT02028780|OG000|Outcome|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
10924349|NCT00683644|OG000|Outcome|Zinc|Participants that completed 4 months taking Zinc (50 mg) daily, either from baseline to month 4, or after washout period, from month 5 to 9).
10924350|NCT00683644|OG001|Outcome|Placebo|Participants that completed 4 months taking placebo capsules daily, either from baseline to month 4 or after a washout period of 1 month (from month 5 to month 9).
10924351|NCT00683644|OG000|Outcome|Zinc|Participants who completed 4 months taking Zinc (50 mg) daily, either from baseline to month 4, or after washout period, from month 5 to 9).
10924352|NCT00683644|OG001|Outcome|Placebo|Participants who completed 4 months taking placebo capsules daily, either from baseline to month 4, or after washout period of 1 month (from month 5 to 9).
10924353|NCT00683644|OG000|Outcome|Zinc|Zinc sulfate: Zinc sulfate capsules corresponding to 50 mg of elemental zinc, taken once daily. Period of use: 4 months, either on baseline or month 5 (after a washout period: 1 month)
10924354|NCT00683644|OG001|Outcome|Placebo|Placebo taken once daily. Period of use: 4 months, either on baseline or month 5 (after a washout period of 1 month)
10924355|NCT00683644|EG000|Reported Event|Zinc|54 participants received Zinc first and 45 participants received Zinc after 1 month washout. The total number of participants at risk to Zinc is 99.
10924356|NCT00683644|EG001|Reported Event|Placebo|55 participants received Placebo first and 46 participants received Placebo after 1 month washout. The total number of participants at risk to Placebo is 101.
10924357|NCT00683657|BG000|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
10924358|NCT00683657|BG001|Baseline|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
10924359|NCT00683657|BG002|Baseline|Total|Total of all reporting groups
10924360|NCT00683657|FG000|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
10924361|NCT00683657|FG001|Participant Flow|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
10924362|NCT00683657|OG000|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
10924363|NCT00683657|OG001|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
10924364|NCT00683657|EG000|Reported Event|PLACEBO + MET|
10924365|NCT00683657|EG001|Reported Event|SAXA 5MG + MET|
10924366|NCT00683696|BG000|Baseline|CRT=ON|Cardiac Resynchronization Therapy activated.
10924367|NCT00683696|BG001|Baseline|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
10924368|NCT00683696|BG002|Baseline|Total|Total of all reporting groups
10924369|NCT00683696|FG000|Participant Flow|CRT=ON|"Cardiac Resynchronization Therapy activated.~Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=ON."
10924370|NCT00683696|FG001|Participant Flow|CRT=OFF|"Cardiac Resynchronization Therapy deactivated.~Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=OFF."
10924371|NCT00683696|OG000|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
10924372|NCT00683696|OG001|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
10924373|NCT00683696|OG000|Outcome|Subjects That Underwent an Implant Attempt|
10924374|NCT00683696|EG000|Reported Event|CRT=ON|Cardiac Resynchronization Therapy activated.
10924375|NCT00683696|EG001|Reported Event|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
10924376|NCT00683774|BG000|Baseline|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
10924377|NCT00683774|BG001|Baseline|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
10924378|NCT00683774|BG002|Baseline|Total|Total of all reporting groups
10924379|NCT00683774|FG000|Participant Flow|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
10924380|NCT00683774|FG001|Participant Flow|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
10924381|NCT00683774|OG000|Outcome|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
11192012|NCT02136004|BG002|Baseline|Total|Total of all reporting groups
10924382|NCT00683774|OG001|Outcome|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
10924383|NCT00683774|EG000|Reported Event|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
10924384|NCT00683774|EG001|Reported Event|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
10924385|NCT00683800|BG000|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
10924386|NCT00683800|BG001|Baseline|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
10924387|NCT00683800|BG002|Baseline|Total|Total of all reporting groups
10924388|NCT00683800|FG000|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
10924389|NCT00683800|FG001|Participant Flow|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
10924390|NCT00683800|OG000|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
10924391|NCT00683800|OG001|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
10924392|NCT00683800|EG000|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
10924393|NCT00683800|EG001|Reported Event|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
10924394|NCT00683826|BG000|Baseline|Leucine 4 Grams|Initial intervention.
10924395|NCT00683826|BG001|Baseline|Leucine 8 Grams|Initial intervention.
10924396|NCT00683826|BG002|Baseline|Leucine 0 Grams-control|Initial intervention.
10924397|NCT00683826|BG003|Baseline|Total|Total of all reporting groups
10924398|NCT00683826|FG000|Participant Flow|All Study Participants|This will be a three-way crossover design, where subjects will be randomized into three groups. All subjects will receive all interventions (0g leucine, 4g leucine, 8g leucine) in a randomized order.
10924399|NCT00683826|OG000|Outcome|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
10924400|NCT00683826|OG001|Outcome|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
10924401|NCT00683826|OG002|Outcome|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
10924402|NCT00683826|EG000|Reported Event|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
10924403|NCT00683826|EG001|Reported Event|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
10924404|NCT00683826|EG002|Reported Event|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
10924405|NCT00683852|BG000|Baseline|ADAPT Drug/Drug Group|patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase.
10924406|NCT00683852|BG001|Baseline|ADAPT Placebo Group (Placebo/Placebo & Placebo/Drug Groups)|This data was analyzed for the study by comparing placebo vs. drug. Therefore the two groups (placebo/placebo and placebo/drug) that started with placebo during the first phase of the study are combined as one group. Patients in the placebo/placebo sequence received a placebo treatment during the first phase of the study, and a placebo treatment in the second phase. Patients in the placebo/drug sequence received a placebo treatment during the first phase of the study and they received the aripiprazole drug at a dose of 2 mg/day in the second phase of the study.
10924407|NCT00683852|BG002|Baseline|Total|Total of all reporting groups
10924408|NCT00683852|FG000|Participant Flow|ADAPT Drug/Drug Group|Patients randomly assigned to the drug/drug sequence: the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase.
10924409|NCT00683852|FG001|Participant Flow|ADAPT Placebo/Placebo Group|Patients randomly assigned to the placebo/placebo sequence: the patients will receive a placebo treatment during the first phase of the study, and a placebo treatment in the second phase.
10924410|NCT00683852|FG002|Participant Flow|ADAPT Placebo/Drug Group|Patients will be randomly assigned to placebo during the first phase of the study. In the second phase of the study, they will receive the aripiprazole drug at a dose of 2 mg/day.
10924411|NCT00683852|OG000|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
10924412|NCT00683852|OG001|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
10924413|NCT00683852|OG002|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
10924414|NCT00683852|OG003|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
10924415|NCT00683852|OG000|Outcome|ADAPT Drug Group|Aripiprazole patient-phases from the Drug/Drug and Placebo/Drug Groups
10924416|NCT00683852|OG001|Outcome|ADAPT Placebo Group|Placebo patient-phases from Placebo/Placebo and Placebo/Drug groups.
10924417|NCT00683852|OG000|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
10924418|NCT00683852|OG001|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
10924419|NCT00683852|OG000|Outcome|ADAPT Drug/Drug Group|patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase
10924420|NCT00683852|OG001|Outcome|ADAPT Placebo/Placebo Group|Patients in the placebo/placebo sequence received a placebo treatment during the first phase of the study, and a placebo treatment in the second phase.
10924421|NCT00683852|EG000|Reported Event|Drug/Drug Group|Aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase for drug/drug group.
10924422|NCT00683852|EG001|Reported Event|Placebo/Placebo Group|Patients on placebo in phases 1 and 2
10924423|NCT00683852|EG002|Reported Event|Placebo/Drug Group|Patients on placebo in Phase 1 who are on drug in phase 2 (Aripiprazole 2 mg/day)
10924424|NCT00683878|BG000|Baseline|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924425|NCT00683878|BG001|Baseline|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924426|NCT00683878|BG002|Baseline|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924427|NCT00683878|BG003|Baseline|Total|Total of all reporting groups
10924428|NCT00683878|FG000|Participant Flow|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924429|NCT00683878|FG001|Participant Flow|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924430|NCT00683878|FG002|Participant Flow|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924431|NCT00683878|OG000|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924432|NCT00683878|OG001|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924433|NCT00683878|OG002|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924434|NCT00683878|EG000|Reported Event|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924435|NCT00683878|EG001|Reported Event|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924436|NCT00683878|EG002|Reported Event|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
10924437|NCT00683904|BG000|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
10924438|NCT00683904|BG001|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
10924439|NCT00683904|BG002|Baseline|Total|Total of all reporting groups
10924440|NCT00683904|FG000|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
10924441|NCT00683904|FG001|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL. infused over 30 minutes on Day 1 of each 21-day cycle.
10924442|NCT00683904|OG000|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
10924443|NCT00683904|OG001|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
11175364|NCT02028780|OG001|Outcome|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
11175365|NCT02028780|OG002|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
11175366|NCT02028780|OG003|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
11175367|NCT02028780|OG004|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
10924444|NCT00683904|OG000|Outcome|All Treated|All subjects who received at least 1 dose of either ixabepilone or carboplatin
10924445|NCT00683904|OG000|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
10924446|NCT00683904|OG001|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
11175368|NCT02028780|OG005|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
10924447|NCT00683904|OG000|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
10924448|NCT00683904|OG001|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
10924449|NCT00683904|OG001|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
10924450|NCT00683904|EG000|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
10924451|NCT00683904|EG001|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
10924452|NCT00683930|BG000|Baseline|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
10924453|NCT00683930|BG001|Baseline|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
10924454|NCT00683930|BG002|Baseline|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
10924455|NCT00683930|BG003|Baseline|Total|Total of all reporting groups
10924456|NCT00683930|FG000|Participant Flow|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
10924457|NCT00683930|FG001|Participant Flow|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
10924458|NCT00683930|FG002|Participant Flow|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
10924459|NCT00683930|OG000|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
10924460|NCT00683930|OG001|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
10924461|NCT00683930|OG002|Outcome|Mycophenolate Mofetil 2 g/Day|MMF 500 mg tablets; 4 tablets twice daily for 52 weeks
10924462|NCT00683930|OG003|Outcome|Mycophenolate Mofetil 3 g/Day|MMF 500 mg tablets; 6 tablets twice daily for 52 weeks
10924463|NCT00683930|EG000|Reported Event|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
10924464|NCT00683930|EG001|Reported Event|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
10924465|NCT00683930|EG002|Reported Event|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
10924466|NCT00684021|BG000|Baseline|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
10924467|NCT00684021|BG001|Baseline|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
10924468|NCT00684021|BG002|Baseline|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
10924469|NCT00684021|BG003|Baseline|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
10924470|NCT00684021|BG004|Baseline|Total|Total of all reporting groups
11175369|NCT02028780|OG006|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
10924471|NCT00684021|FG000|Participant Flow|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
10924472|NCT00684021|FG001|Participant Flow|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
11175370|NCT02028780|OG007|Outcome|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11192013|NCT02136004|FG000|Participant Flow|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
10924473|NCT00684021|FG002|Participant Flow|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
10924474|NCT00684021|FG003|Participant Flow|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
10924475|NCT00684021|OG000|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
10924476|NCT00684021|OG001|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
10924477|NCT00684021|OG002|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
10924478|NCT00684021|OG003|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
10924479|NCT00684021|EG000|Reported Event|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
10924480|NCT00684021|EG001|Reported Event|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
10924481|NCT00684021|EG002|Reported Event|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
10924482|NCT00684021|EG003|Reported Event|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
10924483|NCT00684047|BG000|Baseline|FS Grifols Preliminary Part (I)|Subjects treated during FS Grifols Preliminary Part (I) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
10924484|NCT00684047|BG001|Baseline|FS Grifols Primary Part (II)|Subjects treated during FS Grifols Primary Part (II) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
10924485|NCT00684047|BG002|Baseline|Manual Compression Primary Part (II)|Subjects treated with manual compression were analyzed.
10924486|NCT00684047|BG003|Baseline|Total|Total of all reporting groups
10924487|NCT00684047|FG000|Participant Flow|FS Grifols Preliminary Part (I)|FS Grifols was applied in all subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
10924488|NCT00684047|FG001|Participant Flow|FS Grifols Primary Part (II)|FS Grifol was applied in subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
10924489|NCT00684047|FG002|Participant Flow|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
10924490|NCT00684047|OG000|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
10924491|NCT00684047|OG001|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
10924492|NCT00684047|OG000|Outcome|FS Grifols Primary Part (II)|FS Grifol was applied in subjects. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
10924493|NCT00684047|OG001|Outcome|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
10924494|NCT00684047|EG000|Reported Event|FS Grifols [Pooled Preliminary Part (I) + Primary Part (II)]|"The safety population included all subjects treated with FS Grifols in Preliminary Part (I) and Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols): Preliminary Part (I): 72 subjects and Primary Part (II): 110 subjects.~The safety population included five additional subjects treated with FS Grifols instead of manual compression who were not included in the baseline and efficacy outcome analyses."
10924495|NCT00684047|EG001|Reported Event|Manual Compression Primary Part (II)|The safety population included all subjects treated with manual compression in the Manual Compression Primary Part (II). Five subjects randomized to this arm were treated with FS Grifols and thus were removed from this arm for the safety analyses.
10924496|NCT00684060|BG000|Baseline|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
10924497|NCT00684060|BG001|Baseline|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
10924498|NCT00684060|BG002|Baseline|Total|Total of all reporting groups
10924499|NCT00684060|FG000|Participant Flow|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
10924500|NCT00684060|FG001|Participant Flow|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
10924501|NCT00684060|OG000|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
10924502|NCT00684060|OG001|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
11175371|NCT02028780|OG008|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175372|NCT02028780|OG009|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175373|NCT02028780|OG010|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175374|NCT02028780|OG011|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924503|NCT00684060|EG000|Reported Event|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
10924504|NCT00684060|EG001|Reported Event|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
10924505|NCT00684073|BG000|Baseline|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
10924506|NCT00684073|FG000|Participant Flow|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
10924507|NCT00684073|OG000|Outcome|Day 1 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
10924508|NCT00684073|OG001|Outcome|Day 2 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
10924509|NCT00684073|OG002|Outcome|Day 3 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
10924510|NCT00684073|OG003|Outcome|Day 4 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
10924511|NCT00684073|OG004|Outcome|Day 5 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
10924512|NCT00684073|EG000|Reported Event|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
10924513|NCT00684138|BG000|Baseline|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
10924514|NCT00684138|BG001|Baseline|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
10924515|NCT00684138|BG002|Baseline|Total|Total of all reporting groups
10924516|NCT00684138|FG000|Participant Flow|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
10924517|NCT00684138|FG001|Participant Flow|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
10924518|NCT00684138|OG000|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
10924519|NCT00684138|OG001|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
10924520|NCT00684138|EG000|Reported Event|ACRYSOF® ReSTOR® +3.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted only
10924521|NCT00684138|EG001|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted only
10924522|NCT00684138|EG002|Reported Event|ACRYSOF® ReSTOR® +3.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted only
10924523|NCT00684138|EG003|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only
10924524|NCT00684177|BG000|Baseline|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
10924525|NCT00684177|BG001|Baseline|Placebo|Matching placebo
10924526|NCT00684177|BG002|Baseline|Total|Total of all reporting groups
10924527|NCT00684177|FG000|Participant Flow|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
10924528|NCT00684177|FG001|Participant Flow|Placebo|Matching placebo
10924529|NCT00684177|OG000|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
10924530|NCT00684177|OG001|Outcome|Placebo|Matching placebo
10924531|NCT00684177|EG000|Reported Event|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
10924532|NCT00684177|EG001|Reported Event|Placebo|Matching placebo
10924533|NCT00684203|BG000|Baseline|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924534|NCT00684203|BG001|Baseline|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924535|NCT00684203|BG002|Baseline|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924536|NCT00684203|BG003|Baseline|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
10924537|NCT00684203|BG004|Baseline|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924538|NCT00684203|BG005|Baseline|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924539|NCT00684203|BG006|Baseline|Total|Total of all reporting groups
10924540|NCT00684203|FG000|Participant Flow|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924541|NCT00684203|FG001|Participant Flow|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924542|NCT00684203|FG002|Participant Flow|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
11175375|NCT02028780|OG000|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
11175376|NCT02028780|OG001|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924543|NCT00684203|FG003|Participant Flow|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
10924544|NCT00684203|FG004|Participant Flow|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924545|NCT00684203|FG005|Participant Flow|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924546|NCT00684203|OG000|Outcome|Vorapaxar 20 mg Loading Dose PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924547|NCT00684203|OG001|Outcome|Vorapaxar 40 mg Loading Dose PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924548|NCT00684203|OG002|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924549|NCT00684203|OG000|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924550|NCT00684203|OG001|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924551|NCT00684203|OG002|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924552|NCT00684203|OG003|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924553|NCT00684203|OG004|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924554|NCT00684203|OG000|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924555|NCT00684203|OG001|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924556|NCT00684203|OG001|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924557|NCT00684203|OG000|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924558|NCT00684203|OG001|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924559|NCT00684203|OG002|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924560|NCT00684203|EG000|Reported Event|Vorapaxar 20 mg/1 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924561|NCT00684203|EG001|Reported Event|Vorapaxar 20 mg/2.5 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924562|NCT00684203|EG002|Reported Event|Vorapaxar 40 mg/1 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924563|NCT00684203|EG003|Reported Event|Vorapaxar 40 mg/2.5 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924564|NCT00684203|EG004|Reported Event|Placebo/Placebo|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
10924565|NCT00684242|BG000|Baseline|Lenalidomide|10 mg by mouth daily
10924566|NCT00684242|FG000|Participant Flow|Lenalidomide|10 mg by mouth daily
10924567|NCT00684242|OG000|Outcome|Lenalidomide|10 mg by mouth daily
10924568|NCT00684242|EG000|Reported Event|Lenalidomide|10 mg by mouth daily
10924569|NCT00684307|BG000|Baseline|150 mg od|AZD0837 150 mg od
10924570|NCT00684307|BG001|Baseline|300 mg od|AZD0837 300 mg od
10924571|NCT00684307|BG002|Baseline|450 mg od|AZD0837 450 mg od
10924572|NCT00684307|BG003|Baseline|200 mg bd|AZD0837 200 mg bd
10924573|NCT00684307|BG004|Baseline|VKA INR 2-3|
10924574|NCT00684307|BG005|Baseline|Total|Total of all reporting groups
10924575|NCT00684307|FG000|Participant Flow|150 mg od|AZD0837 150 mg od
10924576|NCT00684307|FG001|Participant Flow|300 mg od|AZD0837 300 mg od
10924577|NCT00684307|FG002|Participant Flow|450 mg od|AZD0837 450 mg od
10924578|NCT00684307|FG003|Participant Flow|200 mg bd|AZD0837 200 mg bd
10924579|NCT00684307|FG004|Participant Flow|VKA INR 2-3|
10924580|NCT00684307|OG000|Outcome|150 mg od|AZD0837 150 mg od
10924581|NCT00684307|OG001|Outcome|300 mg od|AZD0837 300 mg od
10924582|NCT00684307|OG002|Outcome|450 mg od|AZD0837 450 mg od
10924583|NCT00684307|OG003|Outcome|200 mg bd|AZD0837 200 mg bd
10924584|NCT00684307|OG004|Outcome|VKA INR 2-3|
10924585|NCT00684307|EG000|Reported Event|AZD0837 150 mg od|
10924586|NCT00684307|EG001|Reported Event|AZD0837 300 mg od|
10924587|NCT00684307|EG002|Reported Event|AZD0837 450 mg od|
10924588|NCT00684307|EG003|Reported Event|AZD0837 200 mg bd|
10924589|NCT00684307|EG004|Reported Event|VKA INR 2-3|
10924590|NCT00684320|BG000|Baseline|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
10924591|NCT00684320|BG001|Baseline|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
10924592|NCT00684320|BG002|Baseline|Total|Total of all reporting groups
10964069|NCT00875667|BG000|Baseline|Lenalidomide|Participants received lenalidomide 25 mg capsules orally every day for 21 days of each 28-day treatment cycle until disease progression or unacceptable toxicity. Participants with moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but < 60mL/min received 10 mg lenalidomide for 21 days of each 28-day cycle (Cycles 1 and 2). After Cycle 2, if the participant remained free of Grade 3 or Grade 4 toxicity, the dose was increased to 15 mg lenalidomide for 21 days of each 28-day treatment cycle until disease progression or unacceptable toxicity.
10924593|NCT00684320|FG000|Participant Flow|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
10924594|NCT00684320|FG001|Participant Flow|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
10924595|NCT00684320|OG000|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
10924596|NCT00684320|OG001|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
10924597|NCT00684320|EG000|Reported Event|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
10924598|NCT00684320|EG001|Reported Event|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
10924599|NCT00684411|BG000|Baseline|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
10924600|NCT00684411|FG000|Participant Flow|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
10924601|NCT00684411|OG000|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
11175377|NCT02028780|OG002|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924602|NCT00684411|EG000|Reported Event|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
10924603|NCT00684424|BG000|Baseline|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
10924604|NCT00684424|FG000|Participant Flow|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
10924605|NCT00684424|OG000|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
10924606|NCT00684424|OG000|Outcome|Pregabalin|
10924607|NCT00684424|EG000|Reported Event|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
10924608|NCT00684515|BG000|Baseline|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
10924609|NCT00684515|BG001|Baseline|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
10924610|NCT00684515|BG002|Baseline|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
10924611|NCT00684515|BG003|Baseline|Total|Total of all reporting groups
10924612|NCT00684515|FG000|Participant Flow|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
10924613|NCT00684515|FG001|Participant Flow|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
10924614|NCT00684515|FG002|Participant Flow|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
10924615|NCT00684515|OG000|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
10924616|NCT00684515|OG001|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
10924617|NCT00684515|OG002|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
10924618|NCT00684515|EG000|Reported Event|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
10924619|NCT00684515|EG001|Reported Event|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
10924620|NCT00684515|EG002|Reported Event|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
10924621|NCT00684541|BG000|Baseline|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
10924622|NCT00684541|BG001|Baseline|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
10924623|NCT00684541|BG002|Baseline|Total|Total of all reporting groups
10924624|NCT00684541|FG000|Participant Flow|Interpretation Modification Program (IMP)|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except that participants received feedback about their responses. Specifically, participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials. Participants received negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials (76 social and 34 nonsocial) in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Thus, participants were assessed with different materials than those seen during the IMP. Each IMP session lasted approximately 20 min.
10924625|NCT00684541|FG001|Participant Flow|Interpretation Control Condition (ICC)|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
10924626|NCT00684541|OG000|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
11192014|NCT02136004|OG000|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
10924627|NCT00684541|OG001|Outcome|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
10924628|NCT00684541|OG001|Outcome|Interpretation Control Condition|"The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.~Interpretation Control Condition: Participants assigned to the PC completed an identical procedure to the IMP procedure except that feedback about participants' performance was not contingent on the type of interpretation (i.e., non-threat or threat) endorsed. Thus, participants in the PC received positive feedback 50% of the time when viewing a threat interpretation and 50% of the time when viewing a non-threat interpretation."
10924629|NCT00684541|EG000|Reported Event|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
10924630|NCT00684541|EG001|Reported Event|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
10924631|NCT00684554|BG000|Baseline|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
10924632|NCT00684554|BG001|Baseline|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
10924633|NCT00684554|BG002|Baseline|Total|Total of all reporting groups
10924634|NCT00684554|FG000|Participant Flow|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
10924635|NCT00684554|FG001|Participant Flow|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
10924636|NCT00684554|OG000|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
10924637|NCT00684554|OG001|Outcome|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
10924638|NCT00684554|EG000|Reported Event|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
10924639|NCT00684554|EG001|Reported Event|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
10924640|NCT00684567|BG000|Baseline|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
10924641|NCT00684567|FG000|Participant Flow|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
10924642|NCT00684567|OG000|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
10924643|NCT00684567|EG000|Reported Event|Radiotherapy/Temozolomide|
10924644|NCT00684593|BG000|Baseline|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
10924645|NCT00684593|BG001|Baseline|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
10924646|NCT00684593|BG002|Baseline|Total|Total of all reporting groups
10924647|NCT00684593|FG000|Participant Flow|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
10924648|NCT00684593|FG001|Participant Flow|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
10924649|NCT00684593|OG000|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
10924650|NCT00684593|OG001|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
10924651|NCT00684593|EG000|Reported Event|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
10924652|NCT00684593|EG001|Reported Event|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
10924653|NCT00684645|BG000|Baseline|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
10924654|NCT00684645|FG000|Participant Flow|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
10924655|NCT00684645|OG000|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
10924656|NCT00684645|EG000|Reported Event|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
10924657|NCT00684671|BG000|Baseline|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
10924658|NCT00684671|BG001|Baseline|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
10924659|NCT00684671|BG002|Baseline|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
10924660|NCT00684671|BG003|Baseline|Total|Total of all reporting groups
10924661|NCT00684671|FG000|Participant Flow|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
10924662|NCT00684671|FG001|Participant Flow|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
10924663|NCT00684671|FG002|Participant Flow|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
10924664|NCT00684671|OG000|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
10924665|NCT00684671|OG001|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
10924666|NCT00684671|OG002|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
10924667|NCT00684671|EG000|Reported Event|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
10924668|NCT00684671|EG001|Reported Event|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
10924669|NCT00684671|EG002|Reported Event|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
10924670|NCT00684723|BG000|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
10924671|NCT00684723|FG000|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
10924672|NCT00684723|FG001|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
10924673|NCT00684723|OG000|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
10924674|NCT00684723|OG001|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
10924675|NCT00684723|EG000|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
10924676|NCT00684723|EG001|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high- calorie breakfast.
10924677|NCT00684749|BG000|Baseline|Total Population|All surgical patients
10924678|NCT00684749|FG000|Participant Flow|Total Population|All surgical patients
11175378|NCT02028780|OG003|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924679|NCT00684749|OG000|Outcome|Total Population|All surgical patients
10924680|NCT00684749|EG000|Reported Event|Total Population|All surgical patients
10924681|NCT00684762|BG000|Baseline|Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
11175379|NCT02028780|OG004|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175380|NCT02028780|OG000|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
11175381|NCT02028780|OG001|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
11175382|NCT02028780|OG002|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
10924682|NCT00684762|FG000|Participant Flow|Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours.
10924683|NCT00684762|FG001|Participant Flow|Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
10924684|NCT00684762|OG000|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
10924685|NCT00684762|OG001|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
10924686|NCT00684762|EG000|Reported Event|Cilostazol 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
10924687|NCT00684762|EG001|Reported Event|Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
10924688|NCT00684775|BG000|Baseline|1 Work Plus Naltrexone Prescription|"Work Plus Naltrexone Prescription~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
10924689|NCT00684775|BG001|Baseline|2 Work Plus Naltrexone Contingency|"Work Plus Naltrexone Contingency~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
10924690|NCT00684775|BG002|Baseline|Total|Total of all reporting groups
10924691|NCT00684775|FG000|Participant Flow|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Prescription condition could work and earn salary independent of whether or not they took depot naltrexone injections."
10924692|NCT00684775|FG001|Participant Flow|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Work Plus Naltrexone Contingency participants were required to take monthly depot naltrexone injections to work and earn salary."
10924693|NCT00684775|OG000|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the Work Plus Naltrexone Prescription condition could work and earn wages independent of whether or not the took scheduled injections."
10924694|NCT00684775|OG001|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
10924695|NCT00684775|OG000|Outcome|Work Plus Naltrexone Prescription|Participants could work and earn vouchers but did not to take naltrexone to work and earn vouchers.
11175383|NCT02028780|OG003|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
11175384|NCT02028780|OG004|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175385|NCT02028780|OG005|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175386|NCT02028780|OG006|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924696|NCT00684775|OG001|Outcome|Work Plus Naltrexone Contingency|"Participants could work and earn vouchers and had to take naltrexone to work and earn vouchers: employment-based reinforcement.~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
10924697|NCT00684775|OG000|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone injections for 6 months. Participants in the Work Plus Naltrexone Prescription condition could work and earn wages independent of whether or not the took scheduled injections."
10924698|NCT00684775|OG000|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone monthly, but access to working and earning salary was not contingent on doing so."
10924699|NCT00684775|OG000|Outcome|Work Plus Naltrexone Prescription|Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.
10924700|NCT00684775|OG001|Outcome|Work Plus Naltrexone Contingency|"Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.~Work Plus Naltrexone Contingency: Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
10924701|NCT00684775|OG000|Outcome|Work Plus Naltrexone Prescription|"Participants who complete the oral naltrexone induction (N=38)were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months.Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone monthly, but access to working and earning salary was not contingent on doing so."
10924702|NCT00684775|OG001|Outcome|Work Plus Naltrexone Contingency|"Participants who complete the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
11175387|NCT02028780|OG007|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175388|NCT02028780|OG003|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175389|NCT02028780|OG004|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924703|NCT00684775|EG000|Reported Event|1 Work Plus Naltrexone Prescription|"Work Plus Naltrexone Prescription~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
11175390|NCT02028780|OG005|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175391|NCT02028780|OG006|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175392|NCT02028780|OG000|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
11175393|NCT02028780|EG000|Reported Event|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
11175394|NCT02028780|EG001|Reported Event|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
11175395|NCT02028780|EG002|Reported Event|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
11175396|NCT02028780|EG003|Reported Event|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
10924704|NCT00684775|EG001|Reported Event|2 Work Plus Naltrexone Contingency|"Work Plus Naltrexone Contingency~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
10924705|NCT00684788|BG000|Baseline|Work Plus Naltrexone Prescription|"An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who complete the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
10924706|NCT00684788|BG001|Baseline|Work Plus Naltrexone Contingency|"An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who complete the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months."
10924707|NCT00684788|BG002|Baseline|Total|Total of all reporting groups
10924708|NCT00684788|FG000|Participant Flow|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
10924709|NCT00684788|FG001|Participant Flow|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months."
10924710|NCT00684788|OG000|Outcome|Work Plus Naltrexone Prescription|"An extended-release depot formulation of naltrexone was used. Participants will be offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
10924711|NCT00684788|OG001|Outcome|Work Plus Naltrexone Contingency|"Participants will be offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
11175397|NCT02028780|EG004|Reported Event|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
10924712|NCT00684788|OG000|Outcome|Work Plus Naltrexone Prescription|Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
10924713|NCT00684788|OG001|Outcome|Work Plus Naltrexone Contingency|Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
10924714|NCT00684788|OG000|Outcome|Work Plus Naltrexone Prescription|"Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone, but access to working and earning salary will not be contingent on doing so."
10924715|NCT00684788|OG001|Outcome|Work Plus Naltrexone Contingency|"Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections."
10924716|NCT00684788|OG000|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
10924717|NCT00684788|OG001|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months."
11175398|NCT02028780|EG005|Reported Event|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
11175399|NCT02028780|EG006|Reported Event|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
11175400|NCT02028780|EG007|Reported Event|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924718|NCT00684788|EG000|Reported Event|Work Plus Naltrexone Prescription|"An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months."
10924719|NCT00684788|EG001|Reported Event|Work Plus Naltrexone Contingency|"An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. "
10924720|NCT00684814|BG000|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours.
10924721|NCT00684814|FG000|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
10924722|NCT00684814|FG001|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
10924723|NCT00684814|OG000|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
10924724|NCT00684814|OG001|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
10924725|NCT00684814|EG000|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
10924726|NCT00684814|EG001|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
10924727|NCT00684983|BG000|Baseline|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
10924728|NCT00684983|BG001|Baseline|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
10924729|NCT00684983|BG002|Baseline|Total|Total of all reporting groups
10924730|NCT00684983|FG000|Participant Flow|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
10924731|NCT00684983|FG001|Participant Flow|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
10924732|NCT00684983|OG000|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
10924733|NCT00684983|OG001|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
10924734|NCT00684983|OG000|Outcome|Arm I (Lapatinib Ditosylate, Capecitabine)|"Patients receive capecitabine PO BID on days 1-14 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Lapatinib Ditosylate: Given PO~Quality-of-Life Assessment: Ancillary studies"
10924735|NCT00684983|OG001|Outcome|Arm II (Cixutumumab, Lapatinib Ditosylate, Capecitabine)|"Patients receive capecitabine and lapatinib ditosylate as in Arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Cixutumumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lapatinib Ditosylate: Given PO~Quality-of-Life Assessment: Ancillary studies"
10924736|NCT00684983|EG000|Reported Event|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
10924737|NCT00684983|EG001|Reported Event|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
10924738|NCT00684996|BG000|Baseline|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
10924739|NCT00684996|FG000|Participant Flow|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
10924740|NCT00684996|OG000|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
10924741|NCT00684996|OG000|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
10924742|NCT00684996|OG001|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
11175401|NCT02028780|EG008|Reported Event|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175402|NCT02028780|EG009|Reported Event|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175403|NCT02028780|EG010|Reported Event|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
10924743|NCT00684996|OG000|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity un til the recommended phase II dose (RPTD) of bevacizumab is determined.
10924744|NCT00684996|EG000|Reported Event|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
10924745|NCT00685035|BG000|Baseline|All Study Participants|"Half patients randomly assigned to HFCWC therapy first with a higher-pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period~VEST Airway Clearance System, Model 205 : Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects"
10924746|NCT00685035|FG000|Participant Flow|Higher Pressure/Variable-freq, Then Lower Pressure/Mid-freq|HFCWC therapy first with a higher pressure/variable frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol (2nd Intervention).
10924747|NCT00685035|FG001|Participant Flow|Lower Pressure/Mid-freq, Then Higher Pressure/Variable-freq|HFCWC therapy first with a lower pressure/mid-frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the higher-pressure/variable frequency HFCWC protocol (2nd Intervention).
11175404|NCT02028780|EG011|Reported Event|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
11175405|NCT02028871|BG000|Baseline|Placebo|Placebo first
11175406|NCT02028871|BG001|Baseline|Intranasal Insulin Arm|Active treatment first
11175407|NCT02028871|BG002|Baseline|Total|Total of all reporting groups
11175408|NCT02028871|FG000|Participant Flow|Intranasal Insulin Arm|Active Treatment First
11175409|NCT02028871|FG001|Participant Flow|Placebo|Placebo treatment first
11175410|NCT02028871|OG000|Outcome|Intranasal Insulin Arm|Active Treatment
10924748|NCT00685035|OG000|Outcome|Sputum Wet Weight Higher Pressure/Variable Frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
10924749|NCT00685035|OG001|Outcome|Sputum Wet Weight Lower Pressure/Mid-frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
10924750|NCT00685035|OG002|Outcome|Sputum Dry Weight Higher Pressure/Variable Frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum dry weight was calculated after re-weighing the container."
10924751|NCT00685035|OG003|Outcome|Sputum Dry Weight Lower Pressure/Mid-frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum dry weight was calculated after re-weighing the container."
10924752|NCT00685035|OG000|Outcome|Change in FEV1 Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
10924753|NCT00685035|OG001|Outcome|Change in FEV1 Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
10924754|NCT00685035|OG002|Outcome|Change in FVC Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
10924755|NCT00685035|OG003|Outcome|Change in FVC Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
10924756|NCT00685035|OG000|Outcome|G' Storage Modulus at 1 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
10924757|NCT00685035|OG001|Outcome|G' Storage Modulus at 1 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
10924758|NCT00685035|OG002|Outcome|G' Storage Modulus 100 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
11175411|NCT02028871|OG001|Outcome|Placebo|Placebo treatment
11175412|NCT02028871|OG000|Outcome|Placebo|Placebo
10924759|NCT00685035|OG003|Outcome|G' Storage Modulus 100 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
10924760|NCT00685035|OG004|Outcome|"G Loss Modulus 1 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
10924761|NCT00685035|OG005|Outcome|"G Loss Modulus 1 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
10924762|NCT00685035|OG006|Outcome|"G Loss Modulus 100 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
10924763|NCT00685035|OG007|Outcome|"G Loss Modulus 100 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
10924764|NCT00685035|OG000|Outcome|Perceived Comfort Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
10924765|NCT00685035|OG001|Outcome|Perceived Comfort Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
10924766|NCT00685035|OG002|Outcome|Perceived Effectiveness Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
10924767|NCT00685035|OG003|Outcome|Perceived Effectiveness Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
10924768|NCT00685035|EG000|Reported Event|Lower Pressure/Mid-frequency|
10924769|NCT00685035|EG001|Reported Event|Higher Pressure/Variable Frequency|
11175413|NCT02028871|OG001|Outcome|Intranasal Insulin Arm|Active treatment
11175414|NCT02028871|EG000|Reported Event|Intranasal Insulin|Group Receiving Intranasal Insulin
11175415|NCT02028871|EG001|Reported Event|Placebo|Group Receiving Placebo
11175416|NCT02028871|EG002|Reported Event|Follow up|Total Participants Completed Study
11192015|NCT02136004|EG000|Reported Event|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
11192016|NCT02136238|BG000|Baseline|Non-amputee Control Group|non-amputee healthy controls
10924770|NCT00685139|BG000|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
10924771|NCT00685139|FG000|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast.
10924772|NCT00685139|FG001|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast.
10924773|NCT00685139|OG000|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
10924774|NCT00685139|OG001|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
10924775|NCT00685139|EG000|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran 100 mg following an overnight fast.
11175417|NCT02029040|BG000|Baseline|3% Hypertonic Saline Group|"Once consented, the study drug (in this arm: 3% Hypertonic Saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.~Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments m"
11175418|NCT02029040|BG001|Baseline|0.9% Normal Saline Group|"Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.~Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may"
11175419|NCT02029040|BG002|Baseline|Total|Total of all reporting groups
10924776|NCT00685139|EG001|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
10924777|NCT00685165|BG000|Baseline|Primidone 50 mg Tablets and Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast of at least 10 hours.
10924778|NCT00685165|FG000|Participant Flow|Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, primidone 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours.
10924779|NCT00685165|FG001|Participant Flow|Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the test formulation, Primidone 50 mg, after an overnight fast of at least 10 hours.
10924780|NCT00685165|OG000|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
11175420|NCT02029040|FG000|Participant Flow|0.9% Normal Saline Group|"Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.~3% Hypertonic Saline versus 0.9 % normal saline: Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED)."
11192017|NCT02136238|BG001|Baseline|Experimental Group: Unilateral TR or Wrist-disartic Amputees|Includes groups randomized to receive either TRS Grip 3 voluntary close device or Hosmer 5XA voluntary open device first.
11192018|NCT02136238|BG002|Baseline|Total|Total of all reporting groups
10924781|NCT00685165|OG001|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
10924782|NCT00685165|EG000|Reported Event|Primidone 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
10924783|NCT00685165|EG001|Reported Event|Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
10924784|NCT00685178|BG000|Baseline|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
10924785|NCT00685178|BG001|Baseline|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial"
10924786|NCT00685178|BG002|Baseline|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
10924787|NCT00685178|BG003|Baseline|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
10924788|NCT00685178|BG004|Baseline|Total|Total of all reporting groups
10924789|NCT00685178|FG000|Participant Flow|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
11175421|NCT02029040|FG001|Participant Flow|Hypertonic Saline Group|"Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.~3% Hypertonic Saline versus 0.9 % normal saline: Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED)."
11175422|NCT02029040|OG000|Outcome|3% Hypertonic Saline Group|"Once consented, the study drug (in this arm: 3% Hypertonic Saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.~Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments m"
11175423|NCT02029040|OG001|Outcome|0.9% Normal Saline Group|"Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.~Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may"
11192019|NCT02136238|FG000|Participant Flow|Voluntary Open Device First Then Voluntary Close Device|Voluntary open device (Hosmer 5X hook terminal device) first then voluntary close device (TRS Grip 3 terminal device)
10924790|NCT00685178|FG001|Participant Flow|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial"
10924791|NCT00685178|FG002|Participant Flow|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
11192020|NCT02136238|FG001|Participant Flow|Voluntary Close Device First Then Voluntary Open Device|Voluntary close device (TRS Grip 3 terminal device) first then voluntary open device (Hosmer 5X hook terminal device)
10924792|NCT00685178|FG003|Participant Flow|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
10924793|NCT00685178|OG000|Outcome|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
10924794|NCT00685178|OG001|Outcome|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial"
10924795|NCT00685178|OG002|Outcome|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
10924796|NCT00685178|OG003|Outcome|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
10924797|NCT00685178|EG000|Reported Event|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day."
10924798|NCT00685178|EG001|Reported Event|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day."
10924799|NCT00685178|EG002|Reported Event|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
10924800|NCT00685178|EG003|Reported Event|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
10924801|NCT00685295|BG000|Baseline|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
10924802|NCT00685295|BG001|Baseline|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
10924803|NCT00685295|BG002|Baseline|Total|Total of all reporting groups
10924804|NCT00685295|FG000|Participant Flow|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
10924805|NCT00685295|FG001|Participant Flow|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
10924806|NCT00685295|OG000|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
10924807|NCT00685295|OG001|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
10924808|NCT00685295|OG000|Outcome|Arm 1 / Fentora|"Intervention Group:~Subject receives:~placebo oral/swallowed pill~Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet~Fentanyl: Fentanyl rapid dissolving tablet 100mcg"
10924809|NCT00685295|OG001|Outcome|Arm 2 / Percocet/Prevacid|"Active Comparator Group:~Subject receives:~Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill~Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet~Lansoprazole: lansoprazole 15mg rapidly dissolving tablet~Oxycodone: Oxycodone 5/325 mg tablet"
10924810|NCT00685295|EG000|Reported Event|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
10924811|NCT00685295|EG001|Reported Event|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
10924812|NCT00685334|BG000|Baseline|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
10924813|NCT00685334|BG001|Baseline|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
10924814|NCT00685334|BG002|Baseline|Total|Total of all reporting groups
10924815|NCT00685334|FG000|Participant Flow|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
10924816|NCT00685334|FG001|Participant Flow|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
10924817|NCT00685334|OG000|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
10924818|NCT00685334|OG001|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
10924819|NCT00685334|EG000|Reported Event|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
10924820|NCT00685334|EG001|Reported Event|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
10924821|NCT00685373|BG000|Baseline|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
10924822|NCT00685373|FG000|Participant Flow|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
10924823|NCT00685373|OG000|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
10924824|NCT00685373|EG000|Reported Event|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
10924825|NCT00685399|BG000|Baseline|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
10924826|NCT00685399|BG001|Baseline|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
10924827|NCT00685399|BG002|Baseline|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
10924828|NCT00685399|BG003|Baseline|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
10924829|NCT00685399|BG004|Baseline|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
10924830|NCT00685399|BG005|Baseline|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
10924831|NCT00685399|BG006|Baseline|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
10924832|NCT00685399|BG007|Baseline|Total|Total of all reporting groups
10924833|NCT00685399|FG000|Participant Flow|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22.
10924834|NCT00685399|FG001|Participant Flow|Cohort 2|Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
10924835|NCT00685399|FG002|Participant Flow|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
11192021|NCT02136238|FG002|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
10924836|NCT00685399|FG003|Participant Flow|Cohort 4|Participants who experienced a remission of their uveitis within 8 weeks after receiving their final dose of AIN457 while enrolled in Cohorts 1, 2, 3, 5 or 6 were administered with AIN457 10 mg/kg, i.v. infusion (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
10924837|NCT00685399|FG004|Participant Flow|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
10924838|NCT00685399|FG005|Participant Flow|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
10924839|NCT00685399|FG006|Participant Flow|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
11192022|NCT02136238|OG000|Outcome|Prosthetic Hand 1 (Hosmer 5XA)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1~Hosmer 5XA voluntary opening hook: Voluntary opening prosthetic terminal device (hand)"
10924840|NCT00685399|FG007|Participant Flow|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
10924841|NCT00685399|OG000|Outcome|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
10924842|NCT00685399|OG001|Outcome|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
10924843|NCT00685399|OG002|Outcome|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
10924844|NCT00685399|OG003|Outcome|Cohort 4|Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
10924845|NCT00685399|OG004|Outcome|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
10924846|NCT00685399|OG005|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
10924847|NCT00685399|OG006|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
10924848|NCT00685399|OG007|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
10924849|NCT00685399|OG003|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
10924850|NCT00685399|OG004|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
10924851|NCT00685399|OG005|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
10924852|NCT00685399|OG000|Outcome|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
10924853|NCT00685399|OG001|Outcome|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
10924854|NCT00685399|OG002|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
10924855|NCT00685399|OG003|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
10924856|NCT00685399|OG004|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
10924857|NCT00685399|OG000|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
10924858|NCT00685399|EG000|Reported Event|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
10924859|NCT00685399|EG001|Reported Event|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22.
10924860|NCT00685399|EG002|Reported Event|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
11192023|NCT02136238|OG001|Outcome|Prosthetic Hand 2 (TRS Grip 3)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2~TRS Grip 3 voluntary closing hook: Voluntary closing prosthetic terminal device (hand)"
11192024|NCT02136238|OG002|Outcome|Non-amputee Controls|This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
10924861|NCT00685399|EG003|Reported Event|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
10924862|NCT00685399|EG004|Reported Event|Cohort 6 - Arm 1|Participants were administered with AIN457 300 mg s.c.and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
10924863|NCT00685399|EG005|Reported Event|Cohort 6 - Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
10924864|NCT00685399|EG006|Reported Event|Cohort 6 - Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
10924865|NCT00685399|EG007|Reported Event|Cohort 4 (Extension)|Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
10924866|NCT00685477|BG000|Baseline|All Study Participants|CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments.
10924867|NCT00685477|FG000|Participant Flow|Experimental Sequence ABC|Drug given over 15 minutes infusion followed by infusion over 30 minutes, followed by infusion over 60 minutes
10924868|NCT00685477|FG001|Participant Flow|Experimental Sequence ACB|Drug given over 15 minutes infusion followed by infusion over 60 minutes, followed by infusion over 30 minutes
10924869|NCT00685477|FG002|Participant Flow|Experimental Sequence BAC|Drug given over 30 minutes infusion followed by infusion over 15 minutes, followed by infusion over 60 minutes
10924870|NCT00685477|FG003|Participant Flow|Experimental Sequence BCA|Drug given over 30 minutes infusion followed by infusion over 60 minutes, followed by infusion over 15 minutes
10924871|NCT00685477|FG004|Participant Flow|Experimental Sequence CAB|Drug given over 60 minutes infusion followed by infusion over 15 minutes, followed by infusion over 30 minutes
10924872|NCT00685477|FG005|Participant Flow|Experimental Sequence CBA|Drug given over 60 minutes infusion followed by infusion over 30 minutes, followed by infusion over 15 minutes
10924873|NCT00685477|OG000|Outcome|15min Infusion|Drug given over 15 minutes infusion
10924874|NCT00685477|OG001|Outcome|30 Min Infusion|Drug given over 30 minutes infusion
10924875|NCT00685477|OG002|Outcome|60 Min Infusion|Drug given over 60 minutes infusion
10924876|NCT00685477|OG000|Outcome|15 Minute Infusion|Drug given over 15 minutes
10924877|NCT00685477|OG001|Outcome|30 Minute Infusion|Drug given over 30 minutes
10924878|NCT00685477|OG002|Outcome|60 Minute Infusion|Drug given over 60 minutes
10924879|NCT00685477|EG000|Reported Event|All Study Participants|Drug given over 15 minute infusion to look at lowest coefficient of variation in infusion, followed by infusion over 30 minutes, followed by infusion over 60 minutes
10924880|NCT00685516|BG000|Baseline|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
10924881|NCT00685516|BG001|Baseline|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
10924882|NCT00685516|BG002|Baseline|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
10924883|NCT00685516|BG003|Baseline|Total|Total of all reporting groups
10924884|NCT00685516|FG000|Participant Flow|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
10924885|NCT00685516|FG001|Participant Flow|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
10924886|NCT00685516|FG002|Participant Flow|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
10924887|NCT00685516|OG000|Outcome|Arm I - Green Tea|Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
10924888|NCT00685516|OG001|Outcome|Arm II - Water|Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
10924889|NCT00685516|OG002|Outcome|Arm III - Decaffeinated Black Tea|Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
10924890|NCT00685516|OG000|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
10924891|NCT00685516|OG001|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
10924892|NCT00685516|OG002|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
10924893|NCT00685516|EG000|Reported Event|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
10924894|NCT00685516|EG001|Reported Event|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
10924895|NCT00685516|EG002|Reported Event|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
10924896|NCT00685659|BG000|Baseline|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
10924897|NCT00685659|BG001|Baseline|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
10924898|NCT00685659|BG002|Baseline|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
10924899|NCT00685659|BG003|Baseline|Total|Total of all reporting groups
10924900|NCT00685659|FG000|Participant Flow|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
10924901|NCT00685659|FG001|Participant Flow|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
10924902|NCT00685659|FG002|Participant Flow|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
10924903|NCT00685659|OG000|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
10924904|NCT00685659|OG001|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
10924905|NCT00685659|OG002|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
10924906|NCT00685659|EG000|Reported Event|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
10924907|NCT00685659|EG001|Reported Event|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
10924908|NCT00685659|EG002|Reported Event|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
10924909|NCT00685685|BG000|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
10924910|NCT00685685|FG000|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours.
11175424|NCT02029040|EG000|Reported Event|3% Hypertonic Saline Group|"Once consented, the study drug (in this arm: 3% Hypertonic Saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.~Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete."
11175425|NCT02029040|EG001|Reported Event|0.9% Normal Saline Group|"Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.~Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete."
10924911|NCT00685685|FG001|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mevacor® 40 mg after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours.
10924912|NCT00685685|OG000|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
10924913|NCT00685685|OG001|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
10924914|NCT00685685|EG000|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
10924915|NCT00685685|EG001|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
10924916|NCT00685698|BG000|Baseline|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924917|NCT00685698|FG000|Participant Flow|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924918|NCT00685698|OG000|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924919|NCT00685698|OG000|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924920|NCT00685698|OG001|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924921|NCT00685698|OG000|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924922|NCT00685698|OG001|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924923|NCT00685698|OG000|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924924|NCT00685698|OG001|Outcome|Nemonoxacin (at Test of Cure Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
11175426|NCT02029196|BG000|Baseline|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
10924925|NCT00685698|OG002|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924926|NCT00685698|OG000|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924927|NCT00685698|OG001|Outcome|Nemonoxacin (at Test of Cure Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924928|NCT00685698|OG001|Outcome|Nemonoxacin (at EOT/ET Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924929|NCT00685698|OG002|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924930|NCT00685698|OG001|Outcome|Nemonoxacin (at EOT/ET Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924931|NCT00685698|EG000|Reported Event|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
10924932|NCT00685750|BG000|Baseline|Melanoma 1 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment
10924933|NCT00685750|BG001|Baseline|Melanoma 2 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only
10924934|NCT00685750|BG002|Baseline|Melanoma 3 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment
10924935|NCT00685750|BG003|Baseline|Melanoma 4 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions
10924936|NCT00685750|BG004|Baseline|Melanoma 5 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod
10924937|NCT00685750|BG005|Baseline|Melanoma 6 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab
10924938|NCT00685750|BG006|Baseline|Non-Small Cell Group|Non-small cell lung cancer patients nothing other than any standard of care treatment.
10924939|NCT00685750|BG007|Baseline|Total|Total of all reporting groups
10924940|NCT00685750|FG000|Participant Flow|Melanoma 1 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment
11175427|NCT02029196|BG001|Baseline|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
11175428|NCT02029196|BG002|Baseline|Total|Total of all reporting groups
10924941|NCT00685750|FG001|Participant Flow|Melanoma 2 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only
10924942|NCT00685750|FG002|Participant Flow|Melanoma 3 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment
10924943|NCT00685750|FG003|Participant Flow|Melanoma 4 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions
10924944|NCT00685750|FG004|Participant Flow|Melanoma 5 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod
10924945|NCT00685750|FG005|Participant Flow|Melanoma 6 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab
10924946|NCT00685750|FG006|Participant Flow|Non-Small Cell Group|Non-small cell lung cancer patients nothing other than any standard of care treatment.
10924947|NCT00685750|OG000|Outcome|Melanoma 1 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment
10924948|NCT00685750|OG001|Outcome|Melanoma 2 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only
10924949|NCT00685750|OG002|Outcome|Melanoma 3 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment
10924950|NCT00685750|OG003|Outcome|Melanoma 4 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions
10924951|NCT00685750|OG004|Outcome|Melanoma 5 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod
10924952|NCT00685750|OG005|Outcome|Melanoma 6 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab
10924953|NCT00685750|OG006|Outcome|Non-Small Cell Group|Non-small cell lung cancer patients nothing other than any standard of care treatment.
10924954|NCT00685750|OG000|Outcome|Overall Study Group|
10924955|NCT00685750|OG000|Outcome|GS-positive Group|Patients with cutaneous metastatic melanoma receiving ipilimumab and who tested positive for Gene Signature expression at Visit 1.
10924956|NCT00685750|OG001|Outcome|GS-negative Group|Patients with cutaneous metastatic melanoma receiving ipilimumab and who tested negative for Gene Signature expression at Visit 1.
10924957|NCT00685750|OG002|Outcome|GS-invalid Group|Patients with cutaneous metastatic melanoma receiving ipilimumab and who had invalid tests for Gene Signature expression at Visit 1.
10924958|NCT00685750|EG000|Reported Event|Melanoma 1 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment
10924959|NCT00685750|EG001|Reported Event|Melanoma 2 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only
10924960|NCT00685750|EG002|Reported Event|Melanoma 3 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment
10924961|NCT00685750|EG003|Reported Event|Melanoma 4 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions
10924962|NCT00685750|EG004|Reported Event|Melanoma 5 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod
10924963|NCT00685750|EG005|Reported Event|Melanoma 6 Group|Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab
10924964|NCT00685750|EG006|Reported Event|Non-Small Cell Group|Non-small cell lung cancer patients nothing other than any standard of care treatment.
10924965|NCT00685763|BG000|Baseline|Proton Radiation and Chemotherapy|Unresectable Carcinoma of the Pancreas
10924966|NCT00685763|FG000|Participant Flow|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
10924967|NCT00685763|OG000|Outcome|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
11175429|NCT02029196|FG000|Participant Flow|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
11175430|NCT02029196|FG001|Participant Flow|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
11175431|NCT02029196|OG000|Outcome|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
11175432|NCT02029196|OG001|Outcome|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
10924968|NCT00685763|EG000|Reported Event|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
10924969|NCT00685802|BG000|Baseline|Cilostazol 50 mg Tablets and Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either Cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
10924970|NCT00685802|FG000|Participant Flow|Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours.
10924971|NCT00685802|FG001|Participant Flow|Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours.
10924972|NCT00685802|OG000|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
10924973|NCT00685802|OG001|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
10924974|NCT00685802|EG000|Reported Event|Cilostazol 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
10924975|NCT00685802|EG001|Reported Event|Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
10924976|NCT00685932|BG000|Baseline|Control|This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
10924977|NCT00685932|BG001|Baseline|Mobius|This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
10924978|NCT00685932|BG002|Baseline|Total|Total of all reporting groups
10924979|NCT00685932|FG000|Participant Flow|Control|Conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
10924980|NCT00685932|FG001|Participant Flow|Mobius|Subjects underwent cesarean delivery and the Mobius self-retaining retractor was used as the primary method of retraction during hysterotomy, delivery of infant, hysterotomy repair as well as inspection and irrigation. Other conventional retraction was used for the remainder of the procedure as needed. Decision to abandon use of the Mobius was at the discretion of the primary surgeon.
10924981|NCT00685932|OG000|Outcome|Control|This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
10924982|NCT00685932|OG001|Outcome|Mobius|This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
10924983|NCT00685932|EG000|Reported Event|Control|This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
10924984|NCT00685932|EG001|Reported Event|Mobius|This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
10924985|NCT00685945|BG000|Baseline|All Participants|Subjects characteristics for all 24 participants
10924986|NCT00685945|FG000|Participant Flow|All Participants|24 subjects received a bradykinin infusion and then a bradykinin + L-NMMA infusion. Subjects were then randomized to receive either isosorbide (N=12) or sildenafil (N=12). The infusion of bradykinin + L-NMMA was then repeated.
11175433|NCT02029196|EG000|Reported Event|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
10924987|NCT00685945|OG000|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
10924988|NCT00685945|OG001|Outcome|L-NMMA + Control|After the intial bradykinin infusion subjects then received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
10924989|NCT00685945|OG002|Outcome|Isosorbide + L-NMMA + Control|Eleven of the twenty-four subjects were randomized to isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
10924990|NCT00685945|OG003|Outcome|Sildenafil + L-NMMA + Control|Twelve of the twenty-four subjects were randomized to sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
11175434|NCT02029196|EG001|Reported Event|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
11175435|NCT02029235|BG000|Baseline|Acetaminophen/Ibuprofen (AIBU) Group|"Postoperatively, subjects were given:~Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free."
10924991|NCT00685945|OG001|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
10924992|NCT00685945|OG002|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
10924993|NCT00685945|OG003|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
11175436|NCT02029235|BG001|Baseline|Acetaminophen/Hydrocodone (AH) Group|"Postoperatively, subjects were given:~Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free."
11175437|NCT02029235|BG002|Baseline|Total|Total of all reporting groups
11175438|NCT02029235|FG000|Participant Flow|Acetaminophen/Ibuprofen (AIBU) Group|"Postoperatively, subjects were given:~Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free."
11175439|NCT02029235|FG001|Participant Flow|Acetaminophen/Hydrocodone (AH) Group|"Postoperatively, subjects were given:~Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free."
11175440|NCT02029235|OG000|Outcome|Acetaminophen/Ibuprofen (AIBU) Group|"Postoperatively, subjects were given:~Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free."
11175441|NCT02029235|OG001|Outcome|Acetaminophen/Hydrocodone (AH) Group|"Postoperatively, subjects were given:~Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free."
11175442|NCT02029235|EG000|Reported Event|Acetaminophen/Ibuprofen (AIBU) Group|"Acetaminophen 500 mg and Ibuprofen 400 mg~Acetaminophen/Ibuprofen: Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free"
11175443|NCT02029235|EG001|Reported Event|Acetaminophen/Hydrocodone (AH) Group|"Acetaminophen 325 mg and Hydrocodone 5 mg~Acetaminophen/Hydrocodone: Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free"
11175444|NCT02029274|BG000|Baseline|BAF312 0.5mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175445|NCT02029274|BG001|Baseline|BAF312 2mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175446|NCT02029274|BG002|Baseline|BAF312 10 mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175447|NCT02029274|BG003|Baseline|Placebo|During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175448|NCT02029274|BG004|Baseline|Total|Total of all reporting groups
11175449|NCT02029274|FG000|Participant Flow|BAF312 0.5mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
10924994|NCT00685945|EG000|Reported Event|All Participants|Subjects characteristics for all 24 participants
10924995|NCT00686075|BG000|Baseline|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
10924996|NCT00686075|BG001|Baseline|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10924997|NCT00686075|BG002|Baseline|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10924998|NCT00686075|BG003|Baseline|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10924999|NCT00686075|BG004|Baseline|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
10925000|NCT00686075|BG005|Baseline|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
10925001|NCT00686075|BG006|Baseline|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925002|NCT00686075|BG007|Baseline|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
11175450|NCT02029274|FG001|Participant Flow|BAF312 2mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175451|NCT02029274|FG002|Participant Flow|BAF312 10 mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175452|NCT02029274|FG003|Participant Flow|Placebo|During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11192025|NCT02136238|OG000|Outcome|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
10925003|NCT00686075|BG008|Baseline|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925004|NCT00686075|BG009|Baseline|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925005|NCT00686075|BG010|Baseline|Total|Total of all reporting groups
10925006|NCT00686075|FG000|Participant Flow|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
10925007|NCT00686075|FG001|Participant Flow|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925008|NCT00686075|FG002|Participant Flow|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925009|NCT00686075|FG003|Participant Flow|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925010|NCT00686075|FG004|Participant Flow|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
10925011|NCT00686075|FG005|Participant Flow|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
10925012|NCT00686075|FG006|Participant Flow|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925013|NCT00686075|FG007|Participant Flow|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925014|NCT00686075|FG008|Participant Flow|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925015|NCT00686075|FG009|Participant Flow|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925016|NCT00686075|OG000|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
10925017|NCT00686075|OG001|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925018|NCT00686075|OG002|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925019|NCT00686075|OG003|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
11175453|NCT02029274|OG000|Outcome|BAF312 0.5mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175454|NCT02029274|OG001|Outcome|BAF312 2mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175455|NCT02029274|OG002|Outcome|BAF312 10 mg|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175456|NCT02029274|OG003|Outcome|Placebo|During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
10925020|NCT00686075|OG004|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
10925021|NCT00686075|OG005|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
10925022|NCT00686075|OG006|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925023|NCT00686075|OG007|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925024|NCT00686075|OG008|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925025|NCT00686075|OG009|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925026|NCT00686075|EG000|Reported Event|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
10925027|NCT00686075|EG001|Reported Event|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925028|NCT00686075|EG002|Reported Event|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925029|NCT00686075|EG003|Reported Event|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925030|NCT00686075|EG004|Reported Event|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
10925031|NCT00686075|EG005|Reported Event|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
10925032|NCT00686075|EG006|Reported Event|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
11175457|NCT02029274|EG000|Reported Event|Period 1 Placebo|During period 1, participants received matching placebo daily for up to 24 weeks.
11175458|NCT02029274|EG001|Reported Event|Period 1 BAF312 0.5 mg/Day|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks.
10925033|NCT00686075|EG007|Reported Event|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
10925034|NCT00686075|EG008|Reported Event|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925035|NCT00686075|EG009|Reported Event|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
10925036|NCT00686127|BG000|Baseline|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
10925037|NCT00686127|BG001|Baseline|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
10925038|NCT00686127|BG002|Baseline|Total|Total of all reporting groups
10925039|NCT00686127|FG000|Participant Flow|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.
10925040|NCT00686127|FG001|Participant Flow|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
10925041|NCT00686127|OG000|Outcome|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
11175459|NCT02029274|EG002|Reported Event|Period 1 BAF312 2 mg/Day|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
10925042|NCT00686127|OG001|Outcome|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
10925043|NCT00686127|EG000|Reported Event|Lidocaine Patch|Lidocaine patch One patch is changed every twenty-four hours
10925044|NCT00686127|EG001|Reported Event|Placebo Patch|Placebo patch: Patch is changed every 24 hours
10925045|NCT00686166|BG000|Baseline|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
10925046|NCT00686166|FG000|Participant Flow|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
10925047|NCT00686166|OG000|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
10925048|NCT00686166|OG000|Outcome|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
11175460|NCT02029274|EG003|Reported Event|Period 1 BAF312 10 mg/Day|During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks.
11175461|NCT02029274|EG004|Reported Event|Period 2 Placebo /BAF312 2 mg/Day|During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
10925049|NCT00686166|OG001|Outcome|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
10925050|NCT00686166|OG002|Outcome|Tumor Resection|Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
10925051|NCT00686166|EG000|Reported Event|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
10925052|NCT00686166|EG001|Reported Event|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
10925053|NCT00686166|EG002|Reported Event|Tumor Resection|Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
11175462|NCT02029274|EG005|Reported Event|Period 2 BAF312 0.5 mg/Day/BAF312 2 mg/Day|During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
10925054|NCT00686205|BG000|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
10925055|NCT00686205|BG001|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
10925056|NCT00686205|BG002|Baseline|Total|Total of all reporting groups
10925057|NCT00686205|FG000|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
10925058|NCT00686205|FG001|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
11175463|NCT02029274|EG006|Reported Event|Period 2 BAF312 2 mg/Day/BAF312 2 mg/Day|During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175464|NCT02029274|EG007|Reported Event|Period 2 BAF312 10 mg/Day/BAF312 2 mg/Day|During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
11175465|NCT02029417|BG000|Baseline|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
11175466|NCT02029417|FG000|Participant Flow|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
10925059|NCT00686205|OG000|Outcome|HIV Negative Donors|Donors with HIV-1/2 negative results using reference test and negative by HIV-1 RNA test
10925060|NCT00686205|OG000|Outcome|HIV Positive Samples|Known HIV-1 or HIV-2 positive samples were used. Samples were determined to be positive by HIV-1 or HIV-2 western blot.
10925061|NCT00686205|EG000|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
10925062|NCT00686205|EG001|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
10925063|NCT00686231|BG000|Baseline|Overall Study|Healthy subjects older than 18 years were recruited and randomly assigned to one of two study arms on each of two separate study visits. Visit 1: 15mg Nitroglycerin vs. 30 mg Nitroglycerin on one wrist and placebo on the other wrist. Visit 2: 20mg Lidocaine vs. 40mg Lidocaine in combination with Nitroglycerin on one wrist and with placebo on the other wrist.
10925064|NCT00686231|FG000|Participant Flow|Dose-test 15mg|15mg Nitroglycerin on one wrist and Placebo on the other
10925065|NCT00686231|FG001|Participant Flow|Dose-test 30mg|30mg Nitroglycerin on one wrist and Placebo on the other
10925066|NCT00686231|FG002|Participant Flow|Combination Test 20mg|30mg Nitroglycerin + 20mg Lidocaine on one wrist, and Placebo + 20mg Lidocaine on the other wrist
10925067|NCT00686231|FG003|Participant Flow|Combination Test 40mg|30mg Nitroglycerin + 40mg Lidocaine on one wrist, and Placebo + 40mg Lidocaine on the other
10925068|NCT00686231|OG000|Outcome|Placebo|Moisturizing skin cream as a matching placebo was topically applied to one wrist, where 15mg or 30mg (by random assignment) Nitroglycerin was applied to the other wrist
10925069|NCT00686231|OG001|Outcome|15mg Nitroglycerin|15mg of nitroglycerin was administered topically on one wrist (where matching placebo was applied to the other wrist)
10925070|NCT00686231|OG002|Outcome|30mg Nitroglycerin|30mg of nitroglycerin was administered topically on one wrist (where matching placebo was applied to the other wrist)
10925071|NCT00686231|OG000|Outcome|Lidocaine 20mg + Placebo|20mg combination test: lidocaine + placebo
10925072|NCT00686231|OG001|Outcome|Lidocaine 20mg + Nitroglycerin 30mg|20mg combination test: lidocaine + nitroglycerin
10925073|NCT00686231|OG002|Outcome|Lidocaine 40mg + Placebo|40mg combination test: lidocaine + placebo
10925074|NCT00686231|OG003|Outcome|Lidocaine 40mg + Nitroglycerin 30mg|40mg combination test: lidocaine + nitroglycerin
10925075|NCT00686231|EG000|Reported Event|Study|Healthy subjects older than 18 years were recruited and randomly assigned to one of two study arms on each of two separate study visits. Visit 1: 15mg Nitroglycerin vs. 30 mg Nitroglycerin on one wrist and placebo on the other wrist. Visit 2: 20mg Lidocaine vs. 40mg Lidocaine in combination with Nitroglycerin on one wrist and with placebo on the other wrist.
10925076|NCT00686257|BG000|Baseline|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
10925077|NCT00686257|BG001|Baseline|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
10925078|NCT00686257|BG002|Baseline|Total|Total of all reporting groups
10925079|NCT00686257|FG000|Participant Flow|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
10925080|NCT00686257|FG001|Participant Flow|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
10925081|NCT00686257|OG000|Outcome|Control|Received standard face mask
10925082|NCT00686257|OG001|Outcome|Total Face Mask|Received Total Face Mask
10925083|NCT00686257|OG000|Outcome|Oronosal Mask|Standard oronosal mask
10925084|NCT00686257|OG001|Outcome|Total Face Mask|Total Face Mask
10925085|NCT00686257|EG000|Reported Event|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
10925086|NCT00686257|EG001|Reported Event|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
10925087|NCT00686335|BG000|Baseline|Safety Population|all patients that started the run-in period with Cortancyl®
10925088|NCT00686335|FG000|Participant Flow|Safety Population|all patients that started the run-in period with Cortancyl®
10925089|NCT00686335|OG000|Outcome|Lodotra|modified release prednisone
11175467|NCT02029417|OG000|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
11175468|NCT02029417|EG000|Reported Event|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
11175469|NCT02029495|BG000|Baseline|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
10925090|NCT00686335|OG001|Outcome|Cortancyl|immediate release prednisone
10925091|NCT00686335|EG000|Reported Event|Lodotra|modified release prednisone
11175470|NCT02029495|BG001|Baseline|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
10925092|NCT00686335|EG001|Reported Event|Cortancyl|immediate release prednisone
10925093|NCT00686517|BG000|Baseline|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
10925094|NCT00686517|BG001|Baseline|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
10925095|NCT00686517|BG002|Baseline|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
10925096|NCT00686517|BG003|Baseline|Total|Total of all reporting groups
10925097|NCT00686517|FG000|Participant Flow|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
10925098|NCT00686517|FG001|Participant Flow|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
10925099|NCT00686517|FG002|Participant Flow|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
10925100|NCT00686517|OG000|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
10925101|NCT00686517|OG001|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
10925102|NCT00686517|OG002|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
10925103|NCT00686517|EG000|Reported Event|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
10925104|NCT00686517|EG001|Reported Event|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
10925105|NCT00686517|EG002|Reported Event|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
10925106|NCT00686543|BG000|Baseline|Not Randomized|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8).
10925107|NCT00686543|BG001|Baseline|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
10925108|NCT00686543|BG002|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
10925109|NCT00686543|BG003|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
10925110|NCT00686543|BG004|Baseline|Total|Total of all reporting groups
10925111|NCT00686543|FG000|Participant Flow|Not Randomized|Posaconazole oral suspension (POS) 200 mg Three Times a Day (TID) on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8)
10925112|NCT00686543|FG001|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
10925113|NCT00686543|FG002|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg Twice a Day (BID) on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
10925114|NCT00686543|FG003|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
10925115|NCT00686543|OG000|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
10925116|NCT00686543|OG000|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
10925117|NCT00686543|OG001|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
10925118|NCT00686543|OG002|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
10925119|NCT00686543|EG000|Reported Event|POS 200 mg TID on Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements.
10925120|NCT00686543|EG001|Reported Event|POS 200 mg TID on Days 9-15|POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements.
10925121|NCT00686543|EG002|Reported Event|POS 400 mg BID on Days 9-15|POS 400 mg on Days 9-15, administered with food or oral nutritional supplements.
10925122|NCT00686543|EG003|Reported Event|POS 400 mg TID on Days 9-15|POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.
10925123|NCT00686582|BG000|Baseline|Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose|"Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)~1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50"
10925124|NCT00686582|BG001|Baseline|Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose|"Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)~1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50"
10925125|NCT00686582|BG002|Baseline|Vaccinia Experienced, Boosted, Blood Draw Only|"Group 4 Vaccinia Experienced~1 booster dose of MVA-BN in prior study (POX-MVA-005) Blood draw, Screening Visit only (POX-MVA-023)"
10925126|NCT00686582|BG003|Baseline|Total|Total of all reporting groups
10925127|NCT00686582|FG000|Participant Flow|Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose|"Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)~1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50"
10925128|NCT00686582|FG001|Participant Flow|Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose|"Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)~1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50"
10925129|NCT00686582|FG002|Participant Flow|Vaccinia Experienced, Boosted, Blood Draw Only|"Group 4 Vaccinia Experienced~1 booster dose of MVA-BN in prior study (POX-MVA-005) Blood draw, Screening Visit only (POX-MVA-023)"
10925130|NCT00686582|OG000|Outcome|Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose|"Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)~1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50"
10925131|NCT00686582|OG001|Outcome|Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose|"Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)~1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50"
10925132|NCT00686582|EG000|Reported Event|Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose|"Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)~1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50"
11175471|NCT02029495|BG002|Baseline|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
10925133|NCT00686582|EG001|Reported Event|Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose|"Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)~1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50"
10925134|NCT00686595|BG000|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
10925135|NCT00686595|FG000|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
10925136|NCT00686595|OG000|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
10925137|NCT00686595|EG000|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
10925138|NCT00686634|BG000|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg once daily
10925139|NCT00686634|FG000|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg orally once daily
10925140|NCT00686634|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg daily
10925141|NCT00686634|OG000|Outcome|Sitagliptin|Any adverse events while receiving sitagliptin
10925142|NCT00686634|EG000|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg once daily
10925143|NCT00686647|BG000|Baseline|AngioSculpt Device|
10925144|NCT00686647|FG000|Participant Flow|AngioSculpt Device|
10925145|NCT00686647|OG000|Outcome|Overall Study|
10925146|NCT00686647|OG000|Outcome|AngioSculpt Device|
10925147|NCT00686647|EG000|Reported Event|AngioSculpt Device|
10925148|NCT00686686|BG000|Baseline|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
10925149|NCT00686686|FG000|Participant Flow|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
10925150|NCT00686686|OG000|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
10925151|NCT00686686|EG000|Reported Event|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
11175472|NCT02029495|BG003|Baseline|Total|Total of all reporting groups
10925152|NCT00686699|BG000|Baseline|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule BID for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
10925153|NCT00686699|BG001|Baseline|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
10925154|NCT00686699|BG002|Baseline|Total|Total of all reporting groups
10925155|NCT00686699|FG000|Participant Flow|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
10925156|NCT00686699|FG001|Participant Flow|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
10925157|NCT00686699|OG000|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
10925158|NCT00686699|OG001|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
10925159|NCT00686699|EG000|Reported Event|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
10925160|NCT00686699|EG001|Reported Event|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
10925161|NCT00686712|BG000|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
10925162|NCT00686712|BG001|Baseline|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
10925163|NCT00686712|BG002|Baseline|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
10925164|NCT00686712|BG003|Baseline|Total|Total of all reporting groups
10925165|NCT00686712|FG000|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
10925166|NCT00686712|FG001|Participant Flow|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
10925167|NCT00686712|FG002|Participant Flow|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
10925168|NCT00686712|OG000|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
10925169|NCT00686712|OG001|Outcome|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
10925170|NCT00686712|OG002|Outcome|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
10925171|NCT00686712|OG000|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
10925172|NCT00686712|OG001|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
10925173|NCT00686712|OG002|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
10925174|NCT00686712|EG000|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
10925175|NCT00686712|EG001|Reported Event|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
10925176|NCT00686712|EG002|Reported Event|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
10925177|NCT00686725|BG000|Baseline|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
10925178|NCT00686725|BG001|Baseline|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
10925179|NCT00686725|BG002|Baseline|Total|Total of all reporting groups
11175473|NCT02029495|FG000|Participant Flow|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
10925180|NCT00686725|FG000|Participant Flow|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
11175474|NCT02029495|FG001|Participant Flow|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
10925181|NCT00686725|FG001|Participant Flow|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
10925182|NCT00686725|OG000|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
10925183|NCT00686725|OG001|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
10925184|NCT00686725|EG000|Reported Event|Temozolomide Radiation|Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
10925185|NCT00686725|EG001|Reported Event|Temozolomide Alone, Then Temozolomide Radiation|Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
10925186|NCT00686777|BG000|Baseline|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
10925187|NCT00686777|FG000|Participant Flow|Pegylated Interferon Alfa-2b (PEG-IFN) + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
10925188|NCT00686777|OG000|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
10925189|NCT00686777|EG000|Reported Event|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
10925190|NCT00686790|BG000|Baseline|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
10925191|NCT00686790|FG000|Participant Flow|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
10925192|NCT00686790|OG000|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
10925193|NCT00686790|EG000|Reported Event|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
10925194|NCT00686803|BG000|Baseline|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
10925195|NCT00686803|BG001|Baseline|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
10925196|NCT00686803|BG002|Baseline|Placebo|Placebo
11175475|NCT02029495|FG002|Participant Flow|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
10925197|NCT00686803|BG003|Baseline|Total|Total of all reporting groups
10925198|NCT00686803|FG000|Participant Flow|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
10925199|NCT00686803|FG001|Participant Flow|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
10925200|NCT00686803|FG002|Participant Flow|Placebo|Placebo
10925201|NCT00686803|OG000|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
10925202|NCT00686803|OG001|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
10925203|NCT00686803|OG002|Outcome|Placebo|Placebo
10925204|NCT00686803|EG000|Reported Event|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
10925205|NCT00686803|EG001|Reported Event|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
10925206|NCT00686803|EG002|Reported Event|Placebo|Placebo
10925207|NCT00686829|BG000|Baseline|VCV 30 mg|Participants took VCV 30 mg once daily.
10925208|NCT00686829|FG000|Participant Flow|VCV 30 mg|Participants took VCV 30 mg once daily.
10925209|NCT00686829|OG000|Outcome|VCV 30 mg|Participants took VCV 30 mg once daily.
10925210|NCT00686829|EG000|Reported Event|VCV 30 mg|Participants took VCV 30 mg once daily.
10925211|NCT00686842|BG000|Baseline|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
10925212|NCT00686842|FG000|Participant Flow|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
10925213|NCT00686842|OG000|Outcome|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
10925214|NCT00686842|EG000|Reported Event|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
10925215|NCT00686855|BG000|Baseline|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
10925216|NCT00686855|BG001|Baseline|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
10925217|NCT00686855|BG002|Baseline|Total|Total of all reporting groups
10925218|NCT00686855|FG000|Participant Flow|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
10925219|NCT00686855|FG001|Participant Flow|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
10925220|NCT00686855|OG000|Outcome|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
10925221|NCT00686855|OG001|Outcome|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
10925222|NCT00686855|EG000|Reported Event|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
10925223|NCT00686855|EG001|Reported Event|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
10925224|NCT00686881|BG000|Baseline|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
10925225|NCT00686881|BG001|Baseline|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
10925226|NCT00686881|BG002|Baseline|Total|Total of all reporting groups
10925227|NCT00686881|FG000|Participant Flow|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
11175476|NCT02029495|OG000|Outcome|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
10925228|NCT00686881|FG001|Participant Flow|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
10925229|NCT00686881|OG000|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
11175477|NCT02029495|OG001|Outcome|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
10925230|NCT00686881|OG001|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
10925231|NCT00686881|OG000|Outcome|PegIFN-2b|Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
10925232|NCT00686881|OG001|Outcome|SNMC|Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
10925233|NCT00686881|EG000|Reported Event|PegIFN-2b|"Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for~up to 156 weeks."
10925234|NCT00686881|EG001|Reported Event|SNMC|"Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up~to 156 weeks."
10925235|NCT00686894|BG000|Baseline|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
10925236|NCT00686894|FG000|Participant Flow|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
10925237|NCT00686894|OG000|Outcome|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
10925238|NCT00686894|EG000|Reported Event|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
10925239|NCT00686920|BG000|Baseline|New Rifaximin|Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
10925240|NCT00686920|BG001|Baseline|Continuing Rifaximin|Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
10925241|NCT00686920|BG002|Baseline|Total|Total of all reporting groups
10925242|NCT00686920|FG000|Participant Flow|New Rifaximin|Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
10925243|NCT00686920|FG001|Participant Flow|Continuing Rifaximin|Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
10925244|NCT00686920|OG000|Outcome|New Rifaximin|Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
10925245|NCT00686920|OG001|Outcome|Continuing Rifaximin|Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
10925246|NCT00686920|EG000|Reported Event|New Rifaximin|Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
11175478|NCT02029495|OG002|Outcome|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
10925247|NCT00686920|EG001|Reported Event|Continuing Rifaximin|Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
10925248|NCT00686959|BG000|Baseline|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
10925249|NCT00686959|BG001|Baseline|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase) for two 28-day cycles, followed by a 3-5 week Recovery Period, then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
10925250|NCT00686959|BG002|Baseline|Total|Total of all reporting groups
10925251|NCT00686959|FG000|Participant Flow|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.~Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
10925252|NCT00686959|FG001|Participant Flow|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase) for two 28-day cycles, followed by a 3-5 week Recovery Period, then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
10925253|NCT00686959|OG000|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
10925254|NCT00686959|OG001|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase) for two 28-day cycles, followed by a 3-5 week Recovery Period, then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
10925255|NCT00686959|EG000|Reported Event|Arm A:|"Arm A: Participants were treated with pemetrexed plus cisplatin and concurrent thoracic radiation TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles."
10925256|NCT00686959|EG001|Reported Event|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase) for two 28-day cycles, followed by a 3-5 week Recovery Period, then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase"
10925257|NCT00686998|BG000|Baseline|AZD2624|AZD2624 40 mg
10925258|NCT00686998|BG001|Baseline|Placebo|Matching Placebo
11175479|NCT02029495|EG000|Reported Event|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
11175480|NCT02029495|EG001|Reported Event|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
10925259|NCT00686998|BG002|Baseline|Olanzapine|Olanzapine 15 mg
10925260|NCT00686998|BG003|Baseline|Total|Total of all reporting groups
10925261|NCT00686998|FG000|Participant Flow|AZD2624|AZD2624 40 mg
10925262|NCT00686998|FG001|Participant Flow|Placebo|Matching Placebo
10925263|NCT00686998|FG002|Participant Flow|Olanzapine|Olanzapine 15 mg
10925264|NCT00686998|OG000|Outcome|AZD2624|AZD2624 40 mg
10925265|NCT00686998|OG001|Outcome|Placebo|Placebo
10925266|NCT00686998|OG002|Outcome|Olanzapine|Olanzapine 15 mg
10925267|NCT00686998|EG000|Reported Event|AZD2624|AZD2624 40 mg
10925268|NCT00686998|EG001|Reported Event|Placebo|Matching Placebo
10925269|NCT00686998|EG002|Reported Event|Olanzapine|Olanzapine 15 mg
10925270|NCT00687076|BG000|Baseline|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
11175481|NCT02029495|EG002|Reported Event|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
10925271|NCT00687076|BG001|Baseline|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
10925272|NCT00687076|BG002|Baseline|Total|Total of all reporting groups
10925273|NCT00687076|FG000|Participant Flow|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
10925274|NCT00687076|FG001|Participant Flow|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
10925275|NCT00687076|OG000|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
10925276|NCT00687076|OG001|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
10925277|NCT00687076|EG000|Reported Event|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
11175482|NCT02029521|BG000|Baseline|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
11175483|NCT02029521|BG001|Baseline|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
11175484|NCT02029521|BG002|Baseline|Total|Total of all reporting groups
10925278|NCT00687076|EG001|Reported Event|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
10925279|NCT00687102|BG000|Baseline|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
10925280|NCT00687102|BG001|Baseline|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
10925281|NCT00687102|BG002|Baseline|Total|Total of all reporting groups
10925282|NCT00687102|FG000|Participant Flow|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
10925283|NCT00687102|FG001|Participant Flow|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
10925284|NCT00687102|OG000|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
10925285|NCT00687102|OG001|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
10925286|NCT00687102|EG000|Reported Event|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
10925287|NCT00687102|EG001|Reported Event|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
10925288|NCT00687167|BG000|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
10925289|NCT00687167|FG000|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast.
10925290|NCT00687167|FG001|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast.
10925291|NCT00687167|OG000|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
11175485|NCT02029521|FG000|Participant Flow|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
11175486|NCT02029521|FG001|Participant Flow|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
10925292|NCT00687167|OG001|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
10925293|NCT00687167|EG000|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
10925294|NCT00687167|EG001|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
10925295|NCT00687193|BG000|Baseline|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
10925296|NCT00687193|BG001|Baseline|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
10925297|NCT00687193|BG002|Baseline|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
10925298|NCT00687193|BG003|Baseline|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
10925299|NCT00687193|BG004|Baseline|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
10925300|NCT00687193|BG005|Baseline|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
10925301|NCT00687193|BG006|Baseline|Total|Total of all reporting groups
10925302|NCT00687193|FG000|Participant Flow|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
10925303|NCT00687193|FG001|Participant Flow|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
10925304|NCT00687193|FG002|Participant Flow|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
10925305|NCT00687193|FG003|Participant Flow|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
10925306|NCT00687193|FG004|Participant Flow|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
10925307|NCT00687193|FG005|Participant Flow|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
10925308|NCT00687193|OG000|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
10925309|NCT00687193|OG001|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
10925310|NCT00687193|OG002|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
10925311|NCT00687193|OG003|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
10925312|NCT00687193|OG004|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
10925313|NCT00687193|OG005|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
10925314|NCT00687193|OG000|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Missing values were not imputed.
10925315|NCT00687193|OG000|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks
10925316|NCT00687193|OG002|Outcome|CP-690,550 5 mg BID|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
10925317|NCT00687193|EG000|Reported Event|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
10925318|NCT00687193|EG001|Reported Event|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
10925319|NCT00687193|EG002|Reported Event|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
10925320|NCT00687193|EG003|Reported Event|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
10925321|NCT00687193|EG004|Reported Event|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
10925322|NCT00687193|EG005|Reported Event|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
10925323|NCT00687219|BG000|Baseline|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
10925324|NCT00687219|FG000|Participant Flow|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
10925325|NCT00687219|OG000|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
10925326|NCT00687219|EG000|Reported Event|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
10925327|NCT00687271|BG000|Baseline|MK-6213 160 mg + Atorvastatin 20 mg|1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
10925328|NCT00687271|BG001|Baseline|Atorvastatin 20 mg|1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
10925329|NCT00687271|BG002|Baseline|MK-6213 160 mg|1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
10925330|NCT00687271|BG003|Baseline|Placebo|1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
10925331|NCT00687271|BG004|Baseline|Total|Total of all reporting groups
10925332|NCT00687271|FG000|Participant Flow|MK-6213 160 mg + Atorvastatin 20 mg|1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
10925333|NCT00687271|FG001|Participant Flow|Atorvastatin 20 mg|1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
10925334|NCT00687271|FG002|Participant Flow|MK-6213 160 mg|1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
10925335|NCT00687271|FG003|Participant Flow|Placebo|1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
10925336|NCT00687271|OG000|Outcome|MK-6213 160 mg + Atorvastatin 20 mg|1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
10925337|NCT00687271|OG001|Outcome|Atorvastatin 20 mg|1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
10925338|NCT00687271|OG002|Outcome|MK-6213 160 mg|1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
10925339|NCT00687271|OG003|Outcome|Placebo|1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
10925340|NCT00687271|EG000|Reported Event|MK-6213 160 mg + Atorvastatin 20 mg|1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
10925341|NCT00687271|EG001|Reported Event|Atorvastatin 20 mg|1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
10925342|NCT00687271|EG002|Reported Event|MK-6213 160 mg|1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
10925343|NCT00687271|EG003|Reported Event|Placebo|1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
10925344|NCT00687297|BG000|Baseline|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
10925345|NCT00687297|BG001|Baseline|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
10925346|NCT00687297|BG002|Baseline|Total|Total of all reporting groups
10925347|NCT00687297|FG000|Participant Flow|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
10925348|NCT00687297|FG001|Participant Flow|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
10925349|NCT00687297|OG000|Outcome|All Randomized Patients|All patients enrolled in the study
10925350|NCT00687297|OG000|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
10925351|NCT00687297|OG001|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
10925352|NCT00687297|EG000|Reported Event|Treated on Vandetanib Maintenance|Adverse events among patients receiving Vandetanib using the maintenance phase of the study
10925353|NCT00687297|EG001|Reported Event|Treated on Placebo Maintenance|Adverse events among patients receiving placebo during the maintenance phase of the study
10925354|NCT00687297|EG002|Reported Event|All Treated Patients - Induction|Adverse events occurring during induction among all treated patients
10963228|NCT00870896|BG000|Baseline|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
10963229|NCT00870896|FG000|Participant Flow|Group 1|Capsaicin Inhalation challenge (CIH): Each solution of capsaicin administered to a subject will be quantified by HPLC. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until two or more coughs (C2) and five or more coughs (C5) are reached. The different concentrations are delivered at 2 minute intervals. CIH is administered at baseline one and 3 months following treatment with Spiriva
10963230|NCT00870896|OG000|Outcome|Group 1|Capsaicin Inhalation Challenge Testing (CICT) will follow the protocol of Dicpinigaitis et al (Chest 2003; 123:685-8). CICT will be performed at baseline before beginning treatment with tiotropium and at 4 weeks after initiation of treatment. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until five or more coughs (C5) are reached. We measured the change in the number of coughs at baseline and following 30 days of treatment with spiriva
10963231|NCT00870896|OG000|Outcome|Spirometry|We measured the change in FEV1 (in liters) at baseline and following 30 days of treatment with Spiriva.Spirometry will be performed with a KoKO Spirometer, which uses a pneumotachograph to provide Flow/Volume Loops and Volume/Time graphics and multiple incentive graphics for patient coaching. Spirometry will be performed at baseline and at 4 weeks. Normal values will be those of Hankinson, et al (Am J Respir Crit Care Med 159:179-187). Spirometry will also be performed after each dose of inhaled capsaicin. If there is a drop of 20% or more in FEV1 at any time after inhalation of capsaicin, the protocol will be ended at that point.
10963232|NCT00870896|OG000|Outcome|Change in FEV1/FVC|We measured the change in FEV1/FVC ratio before and after treatment with Spiriva. Change in ratio reflects the percentage value at 30 days minus the percentage value at baseline
10925355|NCT00687323|BG000|Baseline|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
10925356|NCT00687323|FG000|Participant Flow|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
10925357|NCT00687323|OG000|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
10925358|NCT00687323|EG000|Reported Event|TEMOZOLOMIDE|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
10925359|NCT00687362|BG000|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
10925360|NCT00687362|FG000|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
10925361|NCT00687362|OG000|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
10925362|NCT00687362|EG000|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
10925363|NCT00687401|BG000|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
10925364|NCT00687401|FG000|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
10925365|NCT00687401|OG000|Outcome|Intent to Treat Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
10925366|NCT00687401|OG001|Outcome|Per Protocol Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
10925367|NCT00687401|EG000|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
10925368|NCT00687440|BG000|Baseline|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
10925369|NCT00687440|FG000|Participant Flow|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
10925370|NCT00687440|OG000|Outcome|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
10925371|NCT00687440|EG000|Reported Event|Caelyx, Docetaxel, Trastuzumab|
10925372|NCT00687453|BG000|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
10925373|NCT00687453|BG001|Baseline|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
10925374|NCT00687453|BG002|Baseline|Total|Total of all reporting groups
10925375|NCT00687453|FG000|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
10925376|NCT00687453|FG001|Participant Flow|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
10925377|NCT00687453|OG000|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
10925378|NCT00687453|OG001|Outcome|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
10925379|NCT00687453|EG000|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
10925380|NCT00687453|EG001|Reported Event|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
10925381|NCT00687544|BG000|Baseline|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
10925382|NCT00687544|FG000|Participant Flow|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
10925383|NCT00687544|OG000|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
10925384|NCT00687544|EG000|Reported Event|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
10925385|NCT00687609|BG000|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
10925386|NCT00687609|FG000|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
10925387|NCT00687609|OG000|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
10925388|NCT00687609|EG000|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
10925389|NCT00687674|BG000|Baseline|Sorafenib + Lenalidomide + Dexamethasone|
10925390|NCT00687674|FG000|Participant Flow|Sorafenib + Lenalidomide + Dexamethasone|
10925391|NCT00687674|OG000|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
10925392|NCT00687674|EG000|Reported Event|Sorafenib + Lenalidomide + Dexamethasone|
11175487|NCT02029521|OG000|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
11175488|NCT02029521|OG001|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
11175489|NCT02029521|OG000|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
10925393|NCT00687713|BG000|Baseline|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
10925394|NCT00687713|BG001|Baseline|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
10925395|NCT00687713|BG002|Baseline|Total|Total of all reporting groups
10925396|NCT00687713|FG000|Participant Flow|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
10925397|NCT00687713|FG001|Participant Flow|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
10925398|NCT00687713|OG000|Outcome|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
10925399|NCT00687713|OG001|Outcome|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
10925400|NCT00687713|OG000|Outcome|Bupropion|"Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
10925401|NCT00687713|OG001|Outcome|Placebo|"Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
10925402|NCT00687713|EG000|Reported Event|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
10925403|NCT00687713|EG001|Reported Event|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
10925404|NCT00687739|BG000|Baseline|GnRH Agonist + Placebo|"GnRH agonist + placebo~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months"
10925405|NCT00687739|BG001|Baseline|GnRH Agonist + Placebo + Exercise|"GnRH agonist + placebo + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
10925406|NCT00687739|BG002|Baseline|GnRH Agonist + Estradiol|"GnRH agonist + Estradiol~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months"
10925407|NCT00687739|BG003|Baseline|GnRH Agonist + Estradiol + Exercise|"GnRH agonist + Estradiol + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
10925408|NCT00687739|BG004|Baseline|Total|Total of all reporting groups
10925409|NCT00687739|FG000|Participant Flow|GnRH Agonist + Placebo|"GnRH agonist + placebo~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months"
10925410|NCT00687739|FG001|Participant Flow|GnRH Agonist + Placebo + Exercise|"GnRH agonist + placebo + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
10925411|NCT00687739|FG002|Participant Flow|GnRH Agonist + Estradiol|"GnRH agonist + Estradiol~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months"
11175490|NCT02029521|OG001|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
11175491|NCT02029521|OG000|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
10925412|NCT00687739|FG003|Participant Flow|GnRH Agonist + Estradiol + Exercise|"GnRH agonist + Estradiol + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
10925413|NCT00687739|OG000|Outcome|GnRHag+PL|"GnRH agonist + placebo~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months"
10925414|NCT00687739|OG001|Outcome|GnRHag+PL+ex|"GnRH agonist + placebo + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
10925415|NCT00687739|OG002|Outcome|GnRHag+E2|"GnRH agonist + Estradiol~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months"
10925416|NCT00687739|OG003|Outcome|GnRHag+E2+ex|"GnRH agonist + Estradiol + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
11175492|NCT02029521|EG000|Reported Event|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
11175493|NCT02029521|EG001|Reported Event|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
11175494|NCT02029638|BG000|Baseline|Enrolled, Screen Failure|Participants were consented and enrolled in the study, but did not receive a full evaluation of all criteria for study participation. These participants were terminated during the screening process due to a decision by study sponsor.
11175495|NCT02029638|BG001|Baseline|Enrolled, Not Transplanted|Participants were consented and enrolled in the study, fulfilling all criteria for study participation. The participants initiated protocol specified pre-transplant treatment, but did not receive a renal transplantation followed by bone marrow infusion, per protocol.
11192026|NCT02136238|OG001|Outcome|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
11192027|NCT02136238|OG002|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
10925417|NCT00687739|OG001|Outcome|GnRHag+E2|"GnRH agonist + estradiol~euprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months"
10925418|NCT00687739|OG003|Outcome|GnRHag+E2+Ex|"GnRH agonist + Estradiol + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
10925419|NCT00687739|EG000|Reported Event|GnRH Agonist + Placebo|"GnRH agonist + placebo~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months"
10925420|NCT00687739|EG001|Reported Event|GnRH Agonist + Placebo + Exercise|"GnRH agonist + placebo + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
10925421|NCT00687739|EG002|Reported Event|GnRH Agonist + Estradiol|"GnRH agonist + Estradiol~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months"
10925422|NCT00687739|EG003|Reported Event|GnRH Agonist + Estradiol + Exercise|"GnRH agonist + Estradiol + exercise~leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months~Estradiol Transdermal: 0.075 mg patch per day for 5 months~progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months"
10925423|NCT00687804|BG000|Baseline|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
10925424|NCT00687804|BG001|Baseline|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
10925425|NCT00687804|BG002|Baseline|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
10925426|NCT00687804|BG003|Baseline|Total|Total of all reporting groups
10925427|NCT00687804|FG000|Participant Flow|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925428|NCT00687804|FG001|Participant Flow|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925429|NCT00687804|FG002|Participant Flow|Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925430|NCT00687804|OG000|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
10925431|NCT00687804|OG001|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
10925432|NCT00687804|OG002|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
11175496|NCT02029638|BG002|Baseline|Enrolled, Transplanted|Participants were consented, enrolled, fulfilling all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks.
10925433|NCT00687804|OG000|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
11175497|NCT02029638|BG003|Baseline|Total|Total of all reporting groups
11175498|NCT02029638|FG000|Participant Flow|Enrolled, Screen Failure|Participants were consented and enrolled in the study, but did not receive a full evaluation of all criteria for study participation. These participants were terminated during the screening process due to a decision by study sponsor
10925434|NCT00687804|OG001|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925435|NCT00687804|OG002|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925436|NCT00687804|OG003|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925437|NCT00687804|OG002|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925438|NCT00687804|EG000|Reported Event|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925439|NCT00687804|EG001|Reported Event|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy"
11175499|NCT02029638|FG001|Participant Flow|Enrolled, Not Transplanted|Participants were consented and enrolled in the study, fulfilling all criteria for study participation. The participants initiated protocol specified pre-transplant treatment, but did not receive a renal transplantation followed by bone marrow infusion, per protocol.
11192028|NCT02136238|EG000|Reported Event|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
11192029|NCT02136238|EG001|Reported Event|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
10925440|NCT00687804|EG002|Reported Event|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925441|NCT00687804|EG003|Reported Event|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
10925442|NCT00687830|BG000|Baseline|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
10925443|NCT00687830|BG001|Baseline|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
10925444|NCT00687830|BG002|Baseline|Total|Total of all reporting groups
10925445|NCT00687830|FG000|Participant Flow|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
10925446|NCT00687830|FG001|Participant Flow|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
10925447|NCT00687830|OG000|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
10925448|NCT00687830|OG001|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
10925449|NCT00687830|EG000|Reported Event|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
10925450|NCT00687830|EG001|Reported Event|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
10925451|NCT00687856|BG000|Baseline|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
10925452|NCT00687856|FG000|Participant Flow|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
10925453|NCT00687856|OG000|Outcome|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
10925454|NCT00687856|EG000|Reported Event|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
10925455|NCT00687908|BG000|Baseline|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
10925456|NCT00687908|BG001|Baseline|Vehicle|Vehicle Gel
10925457|NCT00687908|BG002|Baseline|Total|Total of all reporting groups
10925458|NCT00687908|FG000|Participant Flow|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
10925459|NCT00687908|FG001|Participant Flow|Vehicle|Vehicle Gel
10925460|NCT00687908|OG000|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
10925461|NCT00687908|OG001|Outcome|Vehicle|Vehicle Gel
10925462|NCT00687908|EG000|Reported Event|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
10925463|NCT00687908|EG001|Reported Event|Vehicle|Vehicle Gel
10925464|NCT00687973|BG000|Baseline|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
10925465|NCT00687973|BG001|Baseline|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
10925466|NCT00687973|BG002|Baseline|Total|Total of all reporting groups
10925467|NCT00687973|FG000|Participant Flow|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
10925468|NCT00687973|FG001|Participant Flow|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
11175500|NCT02029638|FG002|Participant Flow|Enrolled, Transplanted|Participants were consented, enrolled, fulfilling all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks.
11175501|NCT02029638|OG000|Outcome|Enrolled, Transplanted|Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks.
11175502|NCT02029638|OG000|Outcome|Enrolled, Transplanted|.Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks.
11175503|NCT02029638|OG000|Outcome|Enrolled, Not Transplanted|Participants were consented and enrolled in the study, but did not receive a full evaluation of all criteria for study participation. These participants were terminated during the screening process due to a decision by study sponsor.
10925469|NCT00687973|OG000|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
10925470|NCT00687973|OG001|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
10925471|NCT00687973|EG000|Reported Event|Amlodipine 5 mg|Run-in: Amlodipine 5 mg
11192030|NCT02136238|EG002|Reported Event|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
10925472|NCT00687973|EG001|Reported Event|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
10925473|NCT00687973|EG002|Reported Event|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
10925474|NCT00688064|BG000|Baseline|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
10925475|NCT00688064|BG001|Baseline|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
10925476|NCT00688064|BG002|Baseline|Total|Total of all reporting groups
10925477|NCT00688064|FG000|Participant Flow|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
10925478|NCT00688064|FG001|Participant Flow|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
10925479|NCT00688064|OG000|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
10925480|NCT00688064|OG001|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
10925481|NCT00688064|EG000|Reported Event|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
10925482|NCT00688064|EG001|Reported Event|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
10925483|NCT00688103|BG000|Baseline|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
10925484|NCT00688103|BG001|Baseline|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
10925485|NCT00688103|BG002|Baseline|Total|Total of all reporting groups
10925486|NCT00688103|FG000|Participant Flow|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
10925487|NCT00688103|FG001|Participant Flow|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
10925488|NCT00688103|OG000|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
10925489|NCT00688103|OG001|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
10925490|NCT00688103|OG000|Outcome|ETN Alone|"etanercept (25mg, twice/week, s.c.)~ETN Alone: etanercept (25 mg, twice/week, s.c.)"
10925491|NCT00688103|OG001|Outcome|ETN+MTX|"etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)~ETN+MTX: etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)"
10925492|NCT00688103|EG000|Reported Event|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
10925493|NCT00688103|EG001|Reported Event|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
10925494|NCT00688155|BG000|Baseline|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
10925495|NCT00688155|BG001|Baseline|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond yes to study words and no to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
10925496|NCT00688155|BG002|Baseline|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
10925497|NCT00688155|BG003|Baseline|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
10925498|NCT00688155|BG004|Baseline|Total|Total of all reporting groups
10925499|NCT00688155|FG000|Participant Flow|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
10925500|NCT00688155|FG001|Participant Flow|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond yes to study words and no to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
10925501|NCT00688155|FG002|Participant Flow|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
10925502|NCT00688155|FG003|Participant Flow|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; Lifestyle Interventions and Independence for Elders, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
10925503|NCT00688155|OG000|Outcome|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
10925504|NCT00688155|OG001|Outcome|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond yes to study words and no to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
10925505|NCT00688155|OG002|Outcome|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
10925506|NCT00688155|OG003|Outcome|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
10925507|NCT00688155|EG000|Reported Event|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
10925508|NCT00688155|EG001|Reported Event|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond yes to study words and no to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
10925509|NCT00688155|EG002|Reported Event|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
10925510|NCT00688155|EG003|Reported Event|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
10925511|NCT00688181|BG000|Baseline|Subjects Treated With the Prefyx PPS System|All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use.
10925512|NCT00688181|FG000|Participant Flow|Subjects Treated With the Prefyx PPS System|All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI) and treated using the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use.
10925513|NCT00688181|OG000|Outcome|Subjects Treated With the Prefyx PPS System|All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use.
10925514|NCT00688181|OG000|Outcome|Subjects Treated With the Prefyx PPS System|All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI), excluding those patients meeting any of the contraindications as noted in the Directions For Use.
10925515|NCT00688181|OG000|Outcome|Subjects Treated With the Prefyx PPS System|All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI), excluding those patients meeting any of the contraindications as noted in the Directions For Use.
10925516|NCT00688181|EG000|Reported Event|Subjects Treated With the Prefyx PPS System|All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use.
10925517|NCT00688259|BG000|Baseline|Cognitive Behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
10925518|NCT00688259|BG001|Baseline|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
10925519|NCT00688259|BG002|Baseline|Total|Total of all reporting groups
10925520|NCT00688259|FG000|Participant Flow|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
10925521|NCT00688259|FG001|Participant Flow|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
10925522|NCT00688259|OG000|Outcome|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
10925523|NCT00688259|OG001|Outcome|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
10925524|NCT00688259|EG000|Reported Event|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
10925525|NCT00688259|EG001|Reported Event|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
10925526|NCT00688324|BG000|Baseline|Baseline Screening|All subjects will have baseline measures
10925527|NCT00688324|FG000|Participant Flow|Single Arm|"All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated.~Acamprosate: Acamprosate 333mg, ii tablets PO tid x 2 weeks"
10925528|NCT00688324|OG000|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
10925529|NCT00688324|OG001|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
10925530|NCT00688324|EG000|Reported Event|Single Arm|"All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated.~Acamprosate: Acamprosate 333mg, ii tablets PO tid x 2 weeks"
10925531|NCT00688467|BG000|Baseline|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
11192031|NCT02136420|BG000|Baseline|Tilt Perception, Training, Placebo|"placebo~Hyper gravity training: Subject receives hypergravity training before testing~Placebo: Placebo"
10925532|NCT00688467|BG001|Baseline|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
11192032|NCT02136420|BG001|Baseline|Manual Control, Training, Placebo|"placebo~Hyper gravity training: Subject receives hypergravity training before testing~Placebo: Placebo"
10925533|NCT00688467|BG002|Baseline|Total|Total of all reporting groups
10925534|NCT00688467|FG000|Participant Flow|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
10925535|NCT00688467|FG001|Participant Flow|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
10925536|NCT00688467|OG000|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
10925537|NCT00688467|OG001|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
10925538|NCT00688467|EG000|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
10925539|NCT00688467|EG001|Reported Event|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
10925540|NCT00688519|BG000|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925541|NCT00688519|BG001|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925542|NCT00688519|BG002|Baseline|Total|Total of all reporting groups
10925543|NCT00688519|FG000|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925544|NCT00688519|FG001|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925545|NCT00688519|OG000|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925546|NCT00688519|OG001|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925547|NCT00688519|EG000|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925548|NCT00688519|EG001|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925549|NCT00688545|BG000|Baseline|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925550|NCT00688545|BG001|Baseline|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925551|NCT00688545|BG002|Baseline|Total|Total of all reporting groups
10925552|NCT00688545|FG000|Participant Flow|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925553|NCT00688545|FG001|Participant Flow|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925554|NCT00688545|OG000|Outcome|Celecoxib|Participants who received celecoxib at any time during the study. Treatment assignment as per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925555|NCT00688545|OG001|Outcome|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925556|NCT00688545|OG000|Outcome|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity
10925557|NCT00688545|OG001|Outcome|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925558|NCT00688545|EG000|Reported Event|Celecoxib|Participants who were prescribed celecoxib at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925559|NCT00688545|EG001|Reported Event|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
10925560|NCT00688597|BG000|Baseline|Cohort 1|Regimen 1: Low-dose duvoglustat (2.5 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks.
10925561|NCT00688597|BG001|Baseline|Cohort 2|Regimen 1: High-dose duvoglustat (5.0 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks.
10925562|NCT00688597|BG002|Baseline|Cohort 3|Regimen 2: High-dose duvoglustat (5.0 g) QD for 7 days, followed by no drug for 7 days, for 11 weeks.
10925563|NCT00688597|BG003|Baseline|Total|Total of all reporting groups
10925564|NCT00688597|FG000|Participant Flow|Cohort 1|Regimen 1: Low-dose duvoglustat (2.5 grams [g]) once a day (QD) for 3 days, followed by no drug for 4 days, for 11 weeks.
10925565|NCT00688597|FG001|Participant Flow|Cohort 2|Regimen 1: High-dose duvoglustat (5.0 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks.
10925566|NCT00688597|FG002|Participant Flow|Cohort 3|Regimen 2: High-dose duvoglustat (5.0 g) QD for 7 days, followed by no drug for 7 days, for 11 weeks.
10925567|NCT00688597|OG000|Outcome|Cohort 1|Regimen 1: Low-dose duvoglustat (2.5 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks.
10925568|NCT00688597|OG001|Outcome|Cohort 2|Regimen 1: High-dose duvoglustat (5.0 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks.
10925569|NCT00688597|OG002|Outcome|Cohort 3|Regimen 2: High-dose duvoglustat (5.0 g) QD for 7 days, followed by no drug for 7 days, for 11 weeks.
10925570|NCT00688597|EG000|Reported Event|Cohort 1|Regimen 1: Low-dose duvoglustat (2.5 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks.
10925571|NCT00688597|EG001|Reported Event|Cohort 2|Regimen 1: High-dose duvoglustat (5.0 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks.
10925572|NCT00688597|EG002|Reported Event|Cohort 3|Regimen 2: High-dose duvoglustat (5.0 g) QD for 7 days, followed by no drug for 7 days, for 11 weeks.
10925573|NCT00688623|BG000|Baseline|Everolimus|10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
11240616|NCT02480764|FG002|Participant Flow|Valsartan 160 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks.
10925574|NCT00688623|FG000|Participant Flow|Everolimus|10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
10925575|NCT00688623|OG000|Outcome|Everolimus|10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
10925576|NCT00688623|EG000|Reported Event|Everolimus|Everolimus
10925577|NCT00688636|BG000|Baseline|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
10925578|NCT00688636|BG001|Baseline|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
10925579|NCT00688636|BG002|Baseline|Total|Total of all reporting groups
10925580|NCT00688636|FG000|Participant Flow|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
10925581|NCT00688636|FG001|Participant Flow|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
10925582|NCT00688636|OG000|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
10925583|NCT00688636|OG001|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
10925584|NCT00688636|EG000|Reported Event|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
10925585|NCT00688636|EG001|Reported Event|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
10925586|NCT00688662|BG000|Baseline|1. ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincter manometry and biliary and/or pancreatic sphincterotomy and pancreatic stenting
10925587|NCT00688662|BG001|Baseline|2. ERCP Without Sphincterotomy|Endoscopic Retrograde CholangioPancreatography(ERCP) with sphincter manometry and pancreatic stenting, but without sphincterotomy
10925588|NCT00688662|BG002|Baseline|Total|Total of all reporting groups
10925589|NCT00688662|FG000|Participant Flow|1.ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with biliary and/or pancreatic sphincterotomy
10925590|NCT00688662|FG001|Participant Flow|2. ERCP Without Sphincterotomy:|Endoscopic Retrograde CholangioPancreatography (ERCP) without biliary and/or pancreatic sphincterotomy
10925591|NCT00688662|OG000|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
10925592|NCT00688662|OG001|Outcome|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
10925593|NCT00688662|OG001|Outcome|2.ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
10925594|NCT00688662|EG000|Reported Event|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
10925595|NCT00688662|EG001|Reported Event|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
10925596|NCT00688688|BG000|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
10925597|NCT00688688|BG001|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
10925598|NCT00688688|BG002|Baseline|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
10925599|NCT00688688|BG003|Baseline|Total|Total of all reporting groups
10925600|NCT00688688|FG000|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
11175504|NCT02029638|OG001|Outcome|Enrolled, Transplanted|Participants were consented, enrolled, fulfilling all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks.
11175505|NCT02029638|EG000|Reported Event|Enrolled, Not Transplanted|Participants were consented and enrolled in the study, but did not receive a full evaluation of all criteria for study participation. These participants were terminated during the screening process due to a decision by study sponsor.
11175506|NCT02029638|EG001|Reported Event|Enrolled, Transplanted|Participants were consented, enrolled, fulfilling all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks.
11175507|NCT02029703|BG000|Baseline|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
10925601|NCT00688688|FG001|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
10925602|NCT00688688|FG002|Participant Flow|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
10925603|NCT00688688|OG000|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
10925604|NCT00688688|OG001|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
11175508|NCT02029703|BG001|Baseline|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
10925605|NCT00688688|OG002|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
11175509|NCT02029703|BG002|Baseline|Total|Total of all reporting groups
11175510|NCT02029703|FG000|Participant Flow|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
11175511|NCT02029703|FG001|Participant Flow|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
11192033|NCT02136420|BG002|Baseline|Perceptual Thresholds,Drug Then Placebo|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.~Promethazine: Subject receives promethazine~Placebo: Placebo"
10925606|NCT00688688|EG000|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
10925607|NCT00688688|EG001|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
10925608|NCT00688688|EG002|Reported Event|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
10925609|NCT00688701|BG000|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
10925610|NCT00688701|BG001|Baseline|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
10925611|NCT00688701|BG002|Baseline|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
10925612|NCT00688701|BG003|Baseline|Total|Total of all reporting groups
10925613|NCT00688701|FG000|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
10925614|NCT00688701|FG001|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
10925615|NCT00688701|FG002|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
10925616|NCT00688701|FG003|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
10925617|NCT00688701|OG000|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
10925618|NCT00688701|OG001|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
10925619|NCT00688701|OG002|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
10925620|NCT00688701|EG000|Reported Event|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo.
10925621|NCT00688701|EG001|Reported Event|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo.
10925622|NCT00688701|EG002|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
10925623|NCT00688701|EG003|Reported Event|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
10925624|NCT00688701|EG004|Reported Event|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
10925625|NCT00688701|EG005|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
11192034|NCT02136420|BG003|Baseline|Perceptual Thresholds,Placebo Then Drug|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.~Promethazine: Subject receives promethazine~Placebo: Placebo"
10925626|NCT00688740|BG000|Baseline|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
10925627|NCT00688740|BG001|Baseline|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
10925628|NCT00688740|BG002|Baseline|Total|Total of all reporting groups
10925629|NCT00688740|FG000|Participant Flow|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
10925630|NCT00688740|FG001|Participant Flow|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
10925631|NCT00688740|OG000|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
10925632|NCT00688740|OG001|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
10925633|NCT00688740|EG000|Reported Event|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
10925634|NCT00688740|EG001|Reported Event|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
10925635|NCT00688753|BG000|Baseline|RAD001 10 mg|two 5 mg tablets of everolimus orally, once daily
10925636|NCT00688753|FG000|Participant Flow|RAD001|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
10925637|NCT00688753|OG000|Outcome|RAD001|10 mg/day
10925638|NCT00688753|EG000|Reported Event|All Patients|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
10925639|NCT00688844|BG000|Baseline|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
10925640|NCT00688844|FG000|Participant Flow|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
10925641|NCT00688844|OG000|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
10925642|NCT00688844|EG000|Reported Event|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
10925643|NCT00688870|BG000|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925644|NCT00688870|BG001|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925645|NCT00688870|BG002|Baseline|Total|Total of all reporting groups
10925646|NCT00688870|FG000|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925647|NCT00688870|FG001|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925648|NCT00688870|OG000|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925649|NCT00688870|OG001|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925650|NCT00688870|EG000|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925651|NCT00688870|EG001|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925652|NCT00688870|EG002|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925653|NCT00688870|EG003|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
10925654|NCT00688870|EG004|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 15 months of age (toddler dose).
10925655|NCT00688870|EG005|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).
10925656|NCT00688909|BG000|Baseline|Letrozole|Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
10925657|NCT00688909|FG000|Participant Flow|Letrozole|Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
10925658|NCT00688909|OG000|Outcome|Letrozole|Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
10925659|NCT00688909|OG000|Outcome|Letrozole|"Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.~letrozole: 2.5 mg daily by mouth for 6 months"
10925660|NCT00688909|EG000|Reported Event|Letrozole 2.5 mg|Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
10925661|NCT00689026|BG000|Baseline|Experimental|PEG plus lubiprostone colon cleansing
10925662|NCT00689026|BG001|Baseline|Control|PEG colon cleansing
10925663|NCT00689026|BG002|Baseline|Total|Total of all reporting groups
10925664|NCT00689026|FG000|Participant Flow|Experimental|Experimental group received one dose of polyethylene glycol electrolyte (PEG) and one does of lubiprostone two hours prior to and two hours after PED completion on the evening prior to the colonoscopy.
10925665|NCT00689026|FG001|Participant Flow|Control|Control group received the standard treatment of polyethylene glycol electrolytes the evening prior to the colonoscopy.
10925666|NCT00689026|OG000|Outcome|Experimental|Lubiprostone: Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4 Liters PEG prep (before and after the 4 Liters PEG prep).
10925667|NCT00689026|OG001|Outcome|Control|All patients in the control will receive a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy.
10925668|NCT00689026|EG000|Reported Event|Treatment|Patients who were given a two doses of lubiprostone with the PEG colon cleansing solution on the day prior the recorded colonoscopy for cleansing grading
10925669|NCT00689026|EG001|Reported Event|Control|Patients received a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy
11192035|NCT02136420|BG004|Baseline|Total|Total of all reporting groups
10925670|NCT00689078|BG000|Baseline|Pred Forte|Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
10925671|NCT00689078|BG001|Baseline|Pred Mild|Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
10925672|NCT00689078|BG002|Baseline|Alrex|Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
10925673|NCT00689078|BG003|Baseline|Tears Naturale (Placebo)|Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
10925674|NCT00689078|BG004|Baseline|Total|Total of all reporting groups
10925675|NCT00689078|FG000|Participant Flow|Pred Forte|1 drop in each eye up to 4 times daily for up to 4 weeks
10925676|NCT00689078|FG001|Participant Flow|Pred Mild|1 drop in each eye up to 4 times daily for up to 4 weeks
10925677|NCT00689078|FG002|Participant Flow|Alrex|1 drop in each eye up to 4 times daily for up to 4 weeks
10925678|NCT00689078|FG003|Participant Flow|Tears Naturale|1 drop in each eye up to 4 times daily for up to 4 weeks
11192036|NCT02136420|FG000|Participant Flow|Tilt Perception, Training, Placebo|placebo
10925679|NCT00689078|OG000|Outcome|Pred Forte|1 drop in each eye up to 4 times daily for up to 4 weeks
10925680|NCT00689078|OG001|Outcome|Pred Mild|1 drop in each eye up to 4 times daily for up to 4 weeks
10925681|NCT00689078|OG002|Outcome|Alrex|1 drop in each eye up to 4 times daily for up to 4 weeks
10925682|NCT00689078|OG003|Outcome|Tears Naturale|1 drop in each eye up to 4 times daily for up to 4 weeks
10925683|NCT00689078|EG000|Reported Event|Pred Forte|1 drop in each eye up to 4 times daily during a 4 week period
10925684|NCT00689078|EG001|Reported Event|Pred Mild|1 drop in each eye up to 4 times daily during a 4 week period
10925685|NCT00689078|EG002|Reported Event|Alrex|1 drop in each eye up to 4 times daily during a 4 week period
10925686|NCT00689078|EG003|Reported Event|Tears Naturale|1 drop in each eye up to 4 times daily during a 4 week period
10925687|NCT00689091|BG000|Baseline|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925688|NCT00689091|BG001|Baseline|Minimum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925689|NCT00689091|BG002|Baseline|Total|Total of all reporting groups
10925690|NCT00689091|FG000|Participant Flow|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925691|NCT00689091|FG001|Participant Flow|Minimum Anesthesia Contration Alert|"This group will receive an alert if total MAC (Minimum Anesthesia Concenration) (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925692|NCT00689091|OG000|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925693|NCT00689091|OG001|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925694|NCT00689091|OG000|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925695|NCT00689091|OG001|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925696|NCT00689091|OG000|Outcome|Spontaneous Reporting|any time up to 30 days
10925697|NCT00689091|OG001|Outcome|Formal Interview Report|at 30 days
10925698|NCT00689091|EG000|Reported Event|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925699|NCT00689091|EG001|Reported Event|Miniumum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
10925700|NCT00689104|BG000|Baseline|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
10925701|NCT00689104|BG001|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
10925702|NCT00689104|BG002|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
10925703|NCT00689104|BG003|Baseline|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
10925704|NCT00689104|BG004|Baseline|Total|Total of all reporting groups
11192037|NCT02136420|FG001|Participant Flow|Tilt Perception, No Training, Placebo|subject does test with no hypergravity training and placebo drug only
11192038|NCT02136420|FG002|Participant Flow|Tilt Perception, Training, Promethazine|promethazine 25 mg, one time 120 minutes prior to experiment
10925705|NCT00689104|FG000|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
10925706|NCT00689104|FG001|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
10925707|NCT00689104|FG002|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
10925708|NCT00689104|FG003|Participant Flow|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
10925709|NCT00689104|OG000|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
10925710|NCT00689104|OG001|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
10925711|NCT00689104|OG002|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
10925712|NCT00689104|OG003|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
10925713|NCT00689104|EG000|Reported Event|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
10925714|NCT00689104|EG001|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
10925715|NCT00689104|EG002|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
10925716|NCT00689104|EG003|Reported Event|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
10925717|NCT00689117|BG000|Baseline|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925718|NCT00689117|BG001|Baseline|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925719|NCT00689117|BG002|Baseline|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925720|NCT00689117|BG003|Baseline|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925721|NCT00689117|BG004|Baseline|Total|Total of all reporting groups
10925722|NCT00689117|FG000|Participant Flow|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925723|NCT00689117|FG001|Participant Flow|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925724|NCT00689117|FG002|Participant Flow|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925725|NCT00689117|FG003|Participant Flow|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925726|NCT00689117|OG000|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925727|NCT00689117|OG001|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925728|NCT00689117|OG002|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925729|NCT00689117|OG003|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925730|NCT00689117|EG000|Reported Event|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925731|NCT00689117|EG001|Reported Event|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925732|NCT00689117|EG002|Reported Event|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925733|NCT00689117|EG003|Reported Event|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
10925734|NCT00689221|BG000|Baseline|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10925735|NCT00689221|BG001|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
10925736|NCT00689221|BG002|Baseline|Total|Total of all reporting groups
11192039|NCT02136420|FG003|Participant Flow|Tilt Perception,No Training,Promethazine|promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training
11192040|NCT02136420|FG004|Participant Flow|Manual Control, Training, Placebo|placebo
10925737|NCT00689221|FG000|Participant Flow|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10925738|NCT00689221|FG001|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
10925739|NCT00689221|OG000|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10925740|NCT00689221|OG001|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
10925741|NCT00689221|EG000|Reported Event|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 will be optional in participants without disease progression, If cilengitide treatment considered beneficial in the opinion of the Investigator,
10925742|NCT00689221|EG001|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
10925743|NCT00689260|BG000|Baseline|Log Aware|Dose Log Aware and Daily Diary Enabled
10925744|NCT00689260|BG001|Baseline|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
10925745|NCT00689260|BG002|Baseline|Total|Total of all reporting groups
10925746|NCT00689260|FG000|Participant Flow|Log Aware|Dose Log Aware and Daily Diary Enabled
10925747|NCT00689260|FG001|Participant Flow|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
10925748|NCT00689260|OG000|Outcome|Log Aware|Dose Log Aware and Daily Diary Enabled
10925749|NCT00689260|OG001|Outcome|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
10925750|NCT00689260|OG002|Outcome|Total|
10925751|NCT00689260|OG000|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
10925752|NCT00689260|OG001|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
10925753|NCT00689260|EG000|Reported Event|Log Aware|Dose Log Aware and Daily Diary Enabled
10925754|NCT00689260|EG001|Reported Event|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
10925755|NCT00689273|BG000|Baseline|PF-04136309|Participants with osteoarthritis of knee received four 125 milligram (mg) capsules of PF-04136309, orally twice daily for 13 days and single morning dose on Day 14.
10925756|NCT00689273|BG001|Baseline|Placebo|Participants with osteoarthritis of knee received placebo matched to four PF-04136309 125 mg capsules, orally twice daily for 13 days and single morning dose on Day 14.
10925757|NCT00689273|BG002|Baseline|Total|Total of all reporting groups
10925758|NCT00689273|FG000|Participant Flow|PF-04136309|Participants with osteoarthritis of knee received four 125 milligram (mg) capsules of PF-04136309, orally twice daily for 13 days and single morning dose on Day 14.
10925759|NCT00689273|FG001|Participant Flow|Placebo|Participants with osteoarthritis of knee received placebo matched to four PF-04136309 125 mg capsules, orally twice daily for 13 days and single morning dose on Day 14.
10925760|NCT00689273|OG000|Outcome|PF-04136309|Participants with osteoarthritis of knee received four 125 milligram (mg) capsules of PF-04136309, orally twice daily for 13 days and single morning dose on Day 14.
10925761|NCT00689273|OG001|Outcome|Placebo|Participants with osteoarthritis of knee received placebo matched to four PF-04136309 125 mg capsules, orally twice daily for 13 days and single morning dose on Day 14.
10925762|NCT00689273|EG000|Reported Event|PF-04136309|Participants with osteoarthritis of knee received four 125 milligram (mg) capsules of PF-04136309, orally twice daily for 13 days and single morning dose on Day 14.
10925763|NCT00689273|EG001|Reported Event|Placebo|Participants with osteoarthritis of knee received placebo matched to four PF-04136309 125 mg capsules, orally twice daily for 13 days and single morning dose on Day 14.
10925764|NCT00689299|BG000|Baseline|Placebo|Placebo - Dose Group C
10925765|NCT00689299|BG001|Baseline|0.21 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (|Active Dose Group A
10925766|NCT00689299|BG002|Baseline|2.1 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (F|Active Dose Group B
10925767|NCT00689299|BG003|Baseline|Total|Total of all reporting groups
10925768|NCT00689299|FG000|Participant Flow|Placebo|Maintenance dose of 0.15 mL of liquid placebo administered as a daily oral liquid via sublingual route.
10925769|NCT00689299|FG001|Participant Flow|2.1 Units Fel d 1|"Active Dose Group B~From a concentration of 14.0 Units/mL of Fel d 1, a maintenance dose of 0.15 mL (2.1 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
10925770|NCT00689299|FG002|Participant Flow|0.21 Units Fel d 1|"Active Dose Group A~From a concentration of 14.0 Units/mL of Fel d 1 diluted 1:10 v/v, a maintenance dose of 0.15 mL (0.21 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
10925771|NCT00689299|OG000|Outcome|Placebo|Dose Group C: placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
10925772|NCT00689299|OG001|Outcome|0.21 Units Standardized Allergenic Extract, Cat Hair|Dose Group A
10925773|NCT00689299|OG002|Outcome|2.1 Units Standardized Allergenic Extract, Cat Hair|Dose Group B
10925774|NCT00689299|EG000|Reported Event|Dose Group C|placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
10925775|NCT00689299|EG001|Reported Event|Dose Group A|0.21 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
10925776|NCT00689299|EG002|Reported Event|Dose Group B|2.1 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
10925777|NCT00689338|BG000|Baseline|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
10925778|NCT00689338|FG000|Participant Flow|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
10925779|NCT00689338|OG000|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
10925780|NCT00689338|EG000|Reported Event|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
10925781|NCT00689351|BG000|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10925782|NCT00689351|BG001|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10925783|NCT00689351|BG002|Baseline|Total|Total of all reporting groups
10925784|NCT00689351|FG000|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10925785|NCT00689351|FG001|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10925786|NCT00689351|OG000|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10925787|NCT00689351|OG001|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
10925788|NCT00689351|EG000|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
10925789|NCT00689351|EG001|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
10925790|NCT00689351|EG002|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
10925791|NCT00689351|EG003|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
10925792|NCT00689351|EG004|Reported Event|Toddler Dose 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered IM at 12 months of age (toddler dose).
10925793|NCT00689351|EG005|Reported Event|Toddler Dose 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC ) 0.5mL dose administered IM at 12 months of age (toddler dose).
10925794|NCT00689390|BG000|Baseline|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
10925795|NCT00689390|BG001|Baseline|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
10925796|NCT00689390|BG002|Baseline|Total|Total of all reporting groups
10925797|NCT00689390|FG000|Participant Flow|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
11192041|NCT02136420|FG005|Participant Flow|Manual Control, No Training, Placebo|subject does test with no hyper gravity training and placebo drug only
11192042|NCT02136420|FG006|Participant Flow|Manual Control, Training, Promethazine|promethazine 25 mg, one time 120 minutes prior to experiment
10925798|NCT00689390|FG001|Participant Flow|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
10925799|NCT00689390|OG000|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
10925800|NCT00689390|OG001|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
10925801|NCT00689390|OG002|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
10925802|NCT00689390|OG000|Outcome|Participants From Boceprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
10925803|NCT00689390|OG001|Outcome|Participants From Narlaprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
10925804|NCT00689390|OG000|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
11192043|NCT02136420|FG007|Participant Flow|Manual Control,No Training,Promethazine|promethazine 25 mg, one time 120 minutes prior to experiment
10925805|NCT00689390|OG001|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
10925806|NCT00689390|EG000|Reported Event|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
10925807|NCT00689390|EG001|Reported Event|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
10925808|NCT00689481|BG000|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925809|NCT00689481|BG001|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925810|NCT00689481|BG002|Baseline|Total|Total of all reporting groups
10925811|NCT00689481|FG000|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925812|NCT00689481|FG001|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925813|NCT00689481|OG000|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925814|NCT00689481|OG001|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925815|NCT00689481|EG000|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925816|NCT00689481|EG001|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
10925817|NCT00689572|BG000|Baseline|Ondansetron|"Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy~Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy"
10925818|NCT00689572|BG001|Baseline|Placebo|"Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy~Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy"
10925819|NCT00689572|BG002|Baseline|Total|Total of all reporting groups
10925820|NCT00689572|FG000|Participant Flow|Ondansetron|"Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy~Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy"
10925821|NCT00689572|FG001|Participant Flow|Placebo|"Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy~Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy"
10925822|NCT00689572|OG000|Outcome|Ondansetron|"Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy~Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy"
10925823|NCT00689572|OG001|Outcome|Placebo|"Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy~Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy"
10925824|NCT00689572|EG000|Reported Event|Ondansetron|"Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy~Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy"
10925825|NCT00689572|EG001|Reported Event|Placebo|"Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy~Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy"
10925826|NCT00689611|BG000|Baseline|Placebo|"participants received placebo for 9 weeks.~Placebo: Placebo"
10925827|NCT00689611|BG001|Baseline|Bupropion|"participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
10925828|NCT00689611|BG002|Baseline|Total|Total of all reporting groups
10925829|NCT00689611|FG000|Participant Flow|Placebo|Participants received placebo for 9 weeks.
10925830|NCT00689611|FG001|Participant Flow|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks."
10925831|NCT00689611|OG000|Outcome|Placebo|Participants received placebo for 9 weeks.
10925832|NCT00689611|OG001|Outcome|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
10925833|NCT00689611|EG000|Reported Event|Placebo|Participants received placebo for 9 weeks.
11175512|NCT02029703|OG000|Outcome|Sham Injection|Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.
11175513|NCT02029703|OG001|Outcome|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
10925834|NCT00689611|EG001|Reported Event|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
10925835|NCT00689728|BG000|Baseline|30 mg LY2127399|30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925836|NCT00689728|BG001|Baseline|80 mg LY2127399|80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925837|NCT00689728|BG002|Baseline|Placebo|Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925838|NCT00689728|BG003|Baseline|Total|Total of all reporting groups
10925839|NCT00689728|FG000|Participant Flow|30 mg LY2127399|"Double-blind: 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.~Rescue: either remain on 30 mg LY2127399 or receive 80 mg LY2127399 up to Week 24.~Optional Follow-up: assessing safety after Week 24, if needed."
11192044|NCT02136420|FG008|Participant Flow|Perceptual Thresholds,Drug Then Placebo|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.~This arm corresponds to results published in Diaz-Artiles et al 2017."
10925840|NCT00689728|FG001|Participant Flow|80 mg LY2127399|"Double-blind: 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.~Rescue: remain on 80 mg LY2127399 up to Week 24. Optional Follow-up: assessing safety after Week 24, if needed."
10925841|NCT00689728|FG002|Participant Flow|Placebo|"Double-blind: Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.~Rescue: either remain on placebo or receive 80 mg LY2127399 up to Week 24. Optional Follow-up: assessing safety after Week 24, if needed."
10925842|NCT00689728|OG000|Outcome|30 mg LY2127399|30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925843|NCT00689728|OG001|Outcome|80 mg LY2127399|80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925844|NCT00689728|OG002|Outcome|Placebo|Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925845|NCT00689728|OG000|Outcome|30 mg LY2127399 - Treatment|30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925846|NCT00689728|OG001|Outcome|80 mg LY2127399 - Treatment|80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925847|NCT00689728|OG002|Outcome|Placebo - Treatment|Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925848|NCT00689728|OG003|Outcome|30 mg LY2127399 - Without Rescue Treatment|30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925849|NCT00689728|OG004|Outcome|30 mg LY2127399 - With Rescue Treatment|Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
10925850|NCT00689728|OG005|Outcome|80 mg LY2127399 - Without Rescue Treatment|80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925851|NCT00689728|OG006|Outcome|80 mg LY2127399 - With Rescue Treatment|Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
10925852|NCT00689728|OG007|Outcome|Placebo - Without Rescue Treatment|Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925853|NCT00689728|OG008|Outcome|Placebo - With Rescue Treatment|Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
10925854|NCT00689728|OG009|Outcome|30 mg LY2127399 - Follow Up|Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
10925855|NCT00689728|OG010|Outcome|80 mg LY2127399 - Follow Up|Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
10925856|NCT00689728|OG011|Outcome|Placebo - Follow Up|Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
10925857|NCT00689728|EG000|Reported Event|30 mg LY2127399 - Treatment|30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925858|NCT00689728|EG001|Reported Event|80 mg LY2127399 - Treatment|80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925859|NCT00689728|EG002|Reported Event|Placebo - Treatment|Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925860|NCT00689728|EG003|Reported Event|30 mg LY2127399 - Without Rescue Treatment|30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925861|NCT00689728|EG004|Reported Event|30 mg LY2127399 - With Rescue Treatment|Participants who were randomized to 30 mg LY2127399 during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.
10925862|NCT00689728|EG005|Reported Event|80 mg LY2127399 - Without Rescue Treatment|80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925863|NCT00689728|EG006|Reported Event|80 mg LY2127399 - With Rescue Treatment|Participants who were randomized to 80 mg LY2127399 during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.
10925864|NCT00689728|EG007|Reported Event|Placebo - Without Rescue Treatment|Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.
10925865|NCT00689728|EG008|Reported Event|Placebo - With Rescue Treatment|Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.
10925866|NCT00689728|EG009|Reported Event|30 mg LY2127399 - Follow-up|Participants who were randomized to 30 mg LY2127399 during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.
10925867|NCT00689728|EG010|Reported Event|80 mg LY2127399 - Follow-up|Participants who were randomized to 80 mg LY2127399 during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.
10925868|NCT00689728|EG011|Reported Event|Placebo - Follow-up|Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.
10925869|NCT00689793|BG000|Baseline|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
10925870|NCT00689793|BG001|Baseline|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
10925871|NCT00689793|BG002|Baseline|Total|Total of all reporting groups
10925872|NCT00689793|FG000|Participant Flow|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
10925873|NCT00689793|FG001|Participant Flow|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
10925874|NCT00689793|OG000|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
10925875|NCT00689793|OG001|Outcome|Placebo|One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
10925876|NCT00689793|OG000|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily), during one month.
10925877|NCT00689793|OG001|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
10925878|NCT00689793|EG000|Reported Event|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
10925879|NCT00689793|EG001|Reported Event|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
10925880|NCT00689819|BG000|Baseline|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
10925881|NCT00689819|BG001|Baseline|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
10925882|NCT00689819|BG002|Baseline|Total|Total of all reporting groups
10925883|NCT00689819|FG000|Participant Flow|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
10925884|NCT00689819|FG001|Participant Flow|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
10925885|NCT00689819|OG000|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
10925886|NCT00689819|OG001|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
10925887|NCT00689819|EG000|Reported Event|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
10925888|NCT00689819|EG001|Reported Event|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
10925889|NCT00689871|BG000|Baseline|Primary Augmentation|All women implanted for an indication of primary breast augmentation
10925890|NCT00689871|BG001|Baseline|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
10925891|NCT00689871|BG002|Baseline|Revision-augmentation|All women implanted for revision of a breast augmentation
10925892|NCT00689871|BG003|Baseline|Revision-reconstruction|All women implanted for revision of a breast reconstruction
10925893|NCT00689871|BG004|Baseline|Total|Total of all reporting groups
10925894|NCT00689871|FG000|Participant Flow|Primary Augmentation|All women implanted for an indication of primary breast augmentation
10925895|NCT00689871|FG001|Participant Flow|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
10925896|NCT00689871|FG002|Participant Flow|Revision-augmentation|All women implanted for revision of a breast augmentation
10925897|NCT00689871|FG003|Participant Flow|Revision-reconstruction|All women implanted for revision of a breast reconstruction
10925898|NCT00689871|OG000|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
10925899|NCT00689871|OG001|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
10925900|NCT00689871|OG002|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
10925901|NCT00689871|OG003|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
10925902|NCT00689871|EG000|Reported Event|Primary Augmentation|All women implanted for an indication of primary breast augmentation
10925903|NCT00689871|EG001|Reported Event|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
10925904|NCT00689871|EG002|Reported Event|Revision-augmentation|All women implanted for revision of a breast augmentation
10925905|NCT00689871|EG003|Reported Event|Revision-reconstruction|All women implanted for revision of a breast reconstruction
10925906|NCT00689936|BG000|Baseline|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
10925907|NCT00689936|BG001|Baseline|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
11175514|NCT02029703|EG000|Reported Event|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
10925908|NCT00689936|BG002|Baseline|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
10925909|NCT00689936|BG003|Baseline|Total|Total of all reporting groups
10925910|NCT00689936|FG000|Participant Flow|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
10925911|NCT00689936|FG001|Participant Flow|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
10925912|NCT00689936|FG002|Participant Flow|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
10925913|NCT00689936|OG000|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
10925914|NCT00689936|OG001|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
10925915|NCT00689936|OG002|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
10925916|NCT00689936|EG000|Reported Event|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
11175515|NCT02029703|EG001|Reported Event|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
10925917|NCT00689936|EG001|Reported Event|Lenalidomide and Dexamethasone (Rd18)|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
10925918|NCT00689936|EG002|Reported Event|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
10925919|NCT00690040|BG000|Baseline|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
10925920|NCT00690040|BG001|Baseline|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
10925921|NCT00690040|BG002|Baseline|Total|Total of all reporting groups
10925922|NCT00690040|FG000|Participant Flow|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
10925923|NCT00690040|FG001|Participant Flow|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
10925924|NCT00690040|OG000|Outcome|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
10925925|NCT00690040|OG001|Outcome|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
10925926|NCT00690040|EG000|Reported Event|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
10925927|NCT00690040|EG001|Reported Event|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
10925928|NCT00690235|BG000|Baseline|Pramlintide|"Volunteers are given 180mg of pramlintide, twice daily~Pramlintide: 180mg subcutaneous injections, twice daily"
10925929|NCT00690235|BG001|Baseline|Placebo|"Patients will be given the Placebo for injection twice daily~Placebo: 180mg subcutaneous injections, twice daily"
10925930|NCT00690235|BG002|Baseline|Total|Total of all reporting groups
10925931|NCT00690235|FG000|Participant Flow|Pramlintide|"volunteers are given 180mg of pramlintide, twice daily~Pramlintide: 180mg subcutaneous injections, twice daily"
10925932|NCT00690235|FG001|Participant Flow|Placebo|"Patients will be given the Placebo for injection twice daily~Placebo: 180mg subcutaneous saline injections, twice daily"
10925933|NCT00690235|OG000|Outcome|Pramlintide|"Volunteers are given 180mg of pramlintide, twice daily~Pramlintide: 180mg subcutaneous injections, twice daily"
10925934|NCT00690235|OG001|Outcome|Placebo|"Volunteers will be given the Placebo for injection twice daily~Placebo: 180mg subcutaneous injections, twice daily"
10925935|NCT00690235|EG000|Reported Event|Pramlintide|"volunteers are given 180mg of pramlintide, twice daily~Pramlintide: 180mg subcutaneous injections, twice daily"
10925936|NCT00690235|EG001|Reported Event|Placebo|"Patients will be given the Placebo for injection twice daily~Placebo: 180mg subcutaneous injections, twice daily"
10925937|NCT00690274|BG000|Baseline|Placebo|"Volunteers are given Placebo, up to 20mg per day~Placebo: up to 20mg per day"
10925938|NCT00690274|BG001|Baseline|BF2.649|"Volunteers are given BF2.649, up to 20mg per day~BF2.649: up to 20mg per day"
10925939|NCT00690274|BG002|Baseline|Total|Total of all reporting groups
10925940|NCT00690274|FG000|Participant Flow|Placebo|"Volunteers are given Placebo, up to 20mg per day~Placebo: up to 20mg per day"
10925941|NCT00690274|FG001|Participant Flow|BF2.649|"Volunteers are given BF2.649, up to 20mg per day~BF2.649: up to 20mg per day"
10925942|NCT00690274|OG000|Outcome|Placebo|"Volunteers are given Placebo, up to 20mg per day~Placebo: up to 20mg per day"
10925943|NCT00690274|OG001|Outcome|BF2.649|"Volunteers are given BF2.649, up to 20mg per day~BF2.649: up to 20mg per day"
10925944|NCT00690274|EG000|Reported Event|Placebo|"Volunteers are given Placebo, up to 20mg per day~Placebo: up to 20mg per day"
10925945|NCT00690274|EG001|Reported Event|BF2.649|"Volunteers are given BF2.649, up to 20mg per day~BF2.649: up to 20mg per day"
10925946|NCT00690339|BG000|Baseline|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925947|NCT00690339|BG001|Baseline|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925948|NCT00690339|BG002|Baseline|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925949|NCT00690339|BG003|Baseline|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925950|NCT00690339|BG004|Baseline|Total|Total of all reporting groups
10925951|NCT00690339|FG000|Participant Flow|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925952|NCT00690339|FG001|Participant Flow|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925953|NCT00690339|FG002|Participant Flow|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925954|NCT00690339|FG003|Participant Flow|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925955|NCT00690339|OG000|Outcome|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925956|NCT00690339|OG001|Outcome|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925957|NCT00690339|OG002|Outcome|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925958|NCT00690339|OG003|Outcome|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925959|NCT00690339|EG000|Reported Event|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925960|NCT00690339|EG001|Reported Event|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925961|NCT00690339|EG002|Reported Event|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
10925962|NCT00690339|EG003|Reported Event|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
11175516|NCT02029755|BG000|Baseline|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
10925963|NCT00690378|BG000|Baseline|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
10925964|NCT00690378|BG001|Baseline|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
10925965|NCT00690378|BG002|Baseline|Total|Total of all reporting groups
10925966|NCT00690378|FG000|Participant Flow|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
10925967|NCT00690378|FG001|Participant Flow|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
10925968|NCT00690378|OG000|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
10925969|NCT00690378|OG001|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
10925970|NCT00690378|EG000|Reported Event|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
10925971|NCT00690378|EG001|Reported Event|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
10925972|NCT00690430|BG000|Baseline|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
10925973|NCT00690430|BG001|Baseline|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
10925974|NCT00690430|BG002|Baseline|Total|Total of all reporting groups
10925975|NCT00690430|FG000|Participant Flow|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
10925976|NCT00690430|FG001|Participant Flow|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
10925977|NCT00690430|FG002|Participant Flow|Extension: Octreotide LAR/Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
10925978|NCT00690430|OG000|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
10925979|NCT00690430|OG001|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
10925980|NCT00690430|EG000|Reported Event|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
11192045|NCT02136420|FG009|Participant Flow|Perceptual Thresholds,Placebo Then Drug|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.~This arm corresponds to results published in Diaz-Artiles et al 2017."
10925981|NCT00690430|EG001|Reported Event|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
10925982|NCT00690430|EG002|Reported Event|Extension Phase Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
10925983|NCT00690430|EG003|Reported Event|Extension Phase Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
10925984|NCT00690430|EG004|Reported Event|Crossover to Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
10925985|NCT00690443|BG000|Baseline|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
10925986|NCT00690443|BG001|Baseline|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
10925987|NCT00690443|BG002|Baseline|Total|Total of all reporting groups
10925988|NCT00690443|FG000|Participant Flow|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
10925989|NCT00690443|FG001|Participant Flow|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
10925990|NCT00690443|OG000|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
10925991|NCT00690443|OG001|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
10925992|NCT00690443|EG000|Reported Event|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
10925993|NCT00690443|EG001|Reported Event|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
10925994|NCT00690482|BG000|Baseline|AZD1981|AZD1981 Oral tablet, twice daily
10925995|NCT00690482|BG001|Baseline|Placebo|Placebo Oral tablet, twice daily
10925996|NCT00690482|BG002|Baseline|Total|Total of all reporting groups
10925997|NCT00690482|FG000|Participant Flow|AZD1981|AZD1981 Oral tablet, twice daily
10925998|NCT00690482|FG001|Participant Flow|Placebo|Placebo Oral tablet, twice daily
10925999|NCT00690482|OG000|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
10926000|NCT00690482|OG001|Outcome|Placebo|Placebo Oral tablet, twice daily
10926001|NCT00690482|EG000|Reported Event|AZD1981|AZD1981 Oral tablet, twice daily
10926002|NCT00690482|EG001|Reported Event|Placebo|Placebo Oral tablet, twice daily
10926003|NCT00690495|BG000|Baseline|Modified Propofol|Modified propofol (Propofol 0.5%)
10926004|NCT00690495|BG001|Baseline|Propofol 1%|Propofol 1%
10926005|NCT00690495|BG002|Baseline|Total|Total of all reporting groups
10926006|NCT00690495|FG000|Participant Flow|Modified Propofol|Modified propofol (Propofol 0.5%)
10926007|NCT00690495|FG001|Participant Flow|Propofol 1%|Propofol 1%
10926008|NCT00690495|OG000|Outcome|Modified Propofol|Modified propofol (Propofol 0.5%)
10926009|NCT00690495|OG001|Outcome|Propofol 1%|Propofol 1%
10926010|NCT00690495|EG000|Reported Event|Modified Propofol|Modified propofol (Propofol 0.5%)
10926011|NCT00690495|EG001|Reported Event|Propofol 1%|Propofol 1%
10926012|NCT00690573|BG000|Baseline|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
10926013|NCT00690573|FG000|Participant Flow|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
10926014|NCT00690573|OG000|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
10926015|NCT00690573|EG000|Reported Event|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
10926016|NCT00690612|BG000|Baseline|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
10926017|NCT00690612|FG000|Participant Flow|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
10926018|NCT00690612|OG000|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
10926019|NCT00690612|EG000|Reported Event|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
10926020|NCT00690755|BG000|Baseline|Group 1|Type 2 diabetic
10926021|NCT00690755|BG001|Baseline|Group 2|Type 1 Diabetic
10926022|NCT00690755|BG002|Baseline|Group 3|Control (non-diabetic)
10926023|NCT00690755|BG003|Baseline|Group 4|Non-Diabetic Overweight
10926024|NCT00690755|BG004|Baseline|Group 5|Non-Diabetic and Type 2 Diabetic subjected to exercise study
10926025|NCT00690755|BG005|Baseline|Group 6|Impaired glucose tolerance (IGT)
10926026|NCT00690755|BG006|Baseline|Group 7|Non-Diabetic treated with Metformin
10926027|NCT00690755|BG007|Baseline|Total|Total of all reporting groups
10926028|NCT00690755|FG000|Participant Flow|Group 1|Type 2 diabetic
10926029|NCT00690755|FG001|Participant Flow|Group 2|Type 1 diabetic
10926030|NCT00690755|FG002|Participant Flow|Group 3|Control (non-diabetic)
10926031|NCT00690755|FG003|Participant Flow|Group 4|Non-diabetic overweight
10926032|NCT00690755|FG004|Participant Flow|Group 5|Non-diabetic and Type 2 diabetic
10926033|NCT00690755|FG005|Participant Flow|Group 6|Impaired glucose tolerance (IGT)
10926034|NCT00690755|FG006|Participant Flow|Group 7|Non-diabetic treated with Metformin
10926035|NCT00690755|OG000|Outcome|Group 1|Type 2 diabetic
10926036|NCT00690755|OG001|Outcome|Group 2|Type 1 diabetic
10926037|NCT00690755|OG002|Outcome|Group 3|Control (non-diabetic)
10926038|NCT00690755|OG003|Outcome|Group 4|Non-diabetic overweight
10926039|NCT00690755|OG004|Outcome|Group 5|Non-diabetic and Type 2 diabetic
10926040|NCT00690755|OG005|Outcome|Group 6|Impaired glucose tolerance (IGT)
10926041|NCT00690755|OG006|Outcome|Group 7|Non-diabetic treated with Metformin
10926042|NCT00690755|EG000|Reported Event|Group 1|Diabetics
10926043|NCT00690755|EG001|Reported Event|Group 2|Type 1 diabetes
10926044|NCT00690755|EG002|Reported Event|Group 3|Control (non-diabetic)
10926045|NCT00690755|EG003|Reported Event|Group 4|Non-diabetic overweight
10926046|NCT00690755|EG004|Reported Event|Group 5|Non-diabetic and Type 2 diabetic
10926047|NCT00690755|EG005|Reported Event|Group 6|Impaired glucose tolerance (IGT)
10926048|NCT00690755|EG006|Reported Event|Group 7|Non-diabetic treated with Metformin
10926049|NCT00690794|BG000|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
10926050|NCT00690794|BG001|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
10926051|NCT00690794|BG002|Baseline|Total|Total of all reporting groups
10926052|NCT00690794|FG000|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
10926053|NCT00690794|FG001|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
10926054|NCT00690794|OG000|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
10926055|NCT00690794|OG001|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
10926056|NCT00690794|EG000|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
10926057|NCT00690794|EG001|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
10926058|NCT00690820|BG000|Baseline|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
10926059|NCT00690820|BG001|Baseline|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
10926060|NCT00690820|BG002|Baseline|Total|Total of all reporting groups
10926061|NCT00690820|FG000|Participant Flow|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
10926062|NCT00690820|FG001|Participant Flow|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
10926063|NCT00690820|OG000|Outcome|Placebo|Placebo treatment
10926064|NCT00690820|OG001|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
10926065|NCT00690820|EG000|Reported Event|Placebo|Placebo treatment
10926066|NCT00690820|EG001|Reported Event|Pancrelipase|Pancrelipase delayed release 12000 units treatment
10926067|NCT00690833|BG000|Baseline|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
10926068|NCT00690833|FG000|Participant Flow|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
10926069|NCT00690833|OG000|Outcome|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
10926070|NCT00690833|EG000|Reported Event|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
10926071|NCT00690898|BG000|Baseline|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
10926072|NCT00690898|FG000|Participant Flow|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
10926073|NCT00690898|OG000|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
10926074|NCT00690898|EG000|Reported Event|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
10926075|NCT00690924|BG000|Baseline|Calcitriol|"calcitriol: Oral~laboratory biomarker analysis: Correlative Study~pharmacological study: Correlative Study"
10926076|NCT00690924|FG000|Participant Flow|Calcitriol|"calcitriol: Oral~laboratory biomarker analysis: Correlative Study~pharmacological study: Correlative Study"
10926077|NCT00690924|OG000|Outcome|Calcitriol|"calcitriol: Oral~laboratory biomarker analysis: Correlative Study~pharmacological study: Correlative Study"
10926078|NCT00690924|EG000|Reported Event|Calcitriol|"calcitriol: Oral~laboratory biomarker analysis: Correlative Study~pharmacological study: Correlative Study"
10926079|NCT00691002|BG000|Baseline|LEO 80190|Once daily application Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)
10926080|NCT00691002|BG001|Baseline|Calcipotriol|Once daily application Calcipotriol 25 mcg/g in the ointment vehicle
11175517|NCT02029755|BG001|Baseline|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11175518|NCT02029755|BG002|Baseline|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11175519|NCT02029755|BG003|Baseline|Total|Total of all reporting groups
11175520|NCT02029755|FG000|Participant Flow|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11175521|NCT02029755|FG001|Participant Flow|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11175522|NCT02029755|FG002|Participant Flow|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11175523|NCT02029755|OG000|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11175524|NCT02029755|OG001|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11175525|NCT02029755|OG002|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11175526|NCT02029755|EG000|Reported Event|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
11192046|NCT02136420|OG000|Outcome|Training, Placebo|"placebo~Hyper gravity training: Subject receives hypergravity training before testing~Placebo: Placebo"
10926081|NCT00691002|BG002|Baseline|Hydrocortisone|Once daily application Hydrocortisone 10 mg/g in the ointment vehicle
10926082|NCT00691002|BG003|Baseline|LEO 80190 Vehicle|Once daily application Ointment Vehicle
10926083|NCT00691002|BG004|Baseline|Total|Total of all reporting groups
10926084|NCT00691002|FG000|Participant Flow|LEO 80190|Once daily application Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)
10926085|NCT00691002|FG001|Participant Flow|Calcipotriol|"Once daily application~Calcipotriol 25 mcg/g in the ointment vehicle"
10926086|NCT00691002|FG002|Participant Flow|Hydrocortisone|"Once daily application~Hydrocortisone 10 mg/g in the ointment vehicle"
10926087|NCT00691002|FG003|Participant Flow|LEO 80190 Vehicle|"Once daily application~Ointment Vehicle"
10926088|NCT00691002|FG004|Participant Flow|Open-label Phase|LEO 80190 ointment : calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment
10926089|NCT00691002|OG000|Outcome|LEO 80190|Once daily application Calcipotriol plus hydrocortisone (LEO 80190)
10926090|NCT00691002|OG001|Outcome|Calcipotriol|Once daily application Calcipotriol 25 mcg/g in the ointment vehicle
10926091|NCT00691002|OG002|Outcome|Hydrocortisone|Once daily application Hydrocortisone 10 mg/g in the ointment vehicle
10926092|NCT00691002|OG003|Outcome|LEO 80190 Vehicle|Once daily application Ointment Vehicle
10926093|NCT00691002|EG000|Reported Event|LEO 80190|Once daily application Calcipotriol plus hydrocortisone (LEO 80190)
10926094|NCT00691002|EG001|Reported Event|Calcipotriol|Once daily application Calcipotriol 25 mcg/g in the ointment vehicle
10926095|NCT00691002|EG002|Reported Event|Hydrocortisone|Once daily application Hydrocortisone 10 mg/g in the ointment vehicle
10926096|NCT00691002|EG003|Reported Event|LEO 80190 Vehicle|Once daily application Ointment Vehicle
10926097|NCT00691002|EG004|Reported Event|Open-label Phase|LEO 80190 ointment : calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment
10926098|NCT00691015|BG000|Baseline|All Participants|"All regimens were analyzed together.~Standard of Care (SOC) Chemotherapy or Standard of Care (SOC) Chemotherapy + total body irradiation~SOC chemotherapy or SOC chemotherapy + total body irradiation (TBI) of one of the following regimens:~Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.~Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.~Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.~Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.~Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.~Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
10926099|NCT00691015|FG000|Participant Flow|Conditioning Regimen|"Chemotherapy or chemotherapy + total body irradiation~Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens:~Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.~Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.~Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.~Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.~Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.~Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
10926100|NCT00691015|OG000|Outcome|All Participants|All regimens were analyzed together.
10926101|NCT00691015|EG000|Reported Event|Conditioning Regimen|"Chemotherapy or chemotherapy + total body irradiation~Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens:~Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.~Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.~Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.~Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.~Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.~Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
10926102|NCT00691028|BG000|Baseline|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
10926103|NCT00691028|BG001|Baseline|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
10926104|NCT00691028|BG002|Baseline|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
10926105|NCT00691028|BG003|Baseline|Total|Total of all reporting groups
10926106|NCT00691028|FG000|Participant Flow|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
10926107|NCT00691028|FG001|Participant Flow|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
10926108|NCT00691028|FG002|Participant Flow|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
10926109|NCT00691028|FG003|Participant Flow|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
10926110|NCT00691028|OG000|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
10926111|NCT00691028|OG001|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
10926112|NCT00691028|OG002|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
10926113|NCT00691028|OG002|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14..
10926114|NCT00691028|OG001|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14..
10926115|NCT00691028|OG000|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14..
10926116|NCT00691028|EG000|Reported Event|TA-650 3 mg/kg (Double-blind)|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
10926117|NCT00691028|EG001|Reported Event|TA-650 6 mg/kg (Double-blind)|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
10926118|NCT00691028|EG002|Reported Event|TA-650 10 mg/kg (Double-blind)|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
10926119|NCT00691028|EG003|Reported Event|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
10926120|NCT00691054|BG000|Baseline|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
10926121|NCT00691054|FG000|Participant Flow|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
10926122|NCT00691054|OG000|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
10926123|NCT00691054|OG000|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
10926124|NCT00691054|OG000|Outcome|Single Arm|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
10926125|NCT00691054|EG000|Reported Event|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
10926126|NCT00691093|BG000|Baseline|Fesoterodine 4 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
10926127|NCT00691093|FG000|Participant Flow|Fesoterodine 4 mg or 8 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
10926128|NCT00691093|OG000|Outcome|Fesoterodine 4 mg|
10926129|NCT00691093|OG001|Outcome|Fesoterodine 8 mg|
10926130|NCT00691093|OG002|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
10926131|NCT00691093|OG000|Outcome|All Subjects|Fesoterodine 4 or 8 mg
10926132|NCT00691093|OG000|Outcome|All Subjects|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
10926133|NCT00691093|OG000|Outcome|All Subjects|Fesoterodine 4 mg or 8 mg
10926134|NCT00691093|EG000|Reported Event|Fesoterodine 4 mg or 8 mg|All Subjects
10926135|NCT00691132|BG000|Baseline|PEITC - Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
10926136|NCT00691132|BG001|Baseline|Placebo - PEITC (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
10926137|NCT00691132|BG002|Baseline|Total|Total of all reporting groups
10926138|NCT00691132|FG000|Participant Flow|PEITC - Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
10926139|NCT00691132|FG001|Participant Flow|Placebo - PEITC (Short-term Trial)|"Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
10926140|NCT00691132|OG000|Outcome|PEITC-Placebo|Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 1 and oral placebo four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.
10926141|NCT00691132|OG001|Outcome|Placebo - PEITC|Participants receive oral placebo four times daily for 5 days in Period 1 and oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.
10926142|NCT00691132|OG000|Outcome|Placebo|Participants receive oral placebo four times daily for 5 days in either Period 1 or Period 2.
10926143|NCT00691132|OG001|Outcome|PEITC|Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in either Period 1 or Period 2.
10926144|NCT00691132|OG000|Outcome|GSTM1 Null|GSTM1 Null: gene for glutathione-S-transferase (GST) M1 (GSTM1), the homozygous deletion of the gene (GSTM1 null), leading to a lack of corresponding enzymatic activity.
10926145|NCT00691132|OG001|Outcome|GSTM1 Present|GSTM1 Present: gene for glutathione-S-transferase (GST) M1 (GSTM1), present in one or both alleles, leading to a enzymatic activity.
10926146|NCT00691132|OG000|Outcome|GSTT1 Null|GSTT1 Null: gene for glutathione-S-transferase (GST) T1 (GSTT1), the homozygous deletion of the gene (GSTT1 null), leading to a lack of corresponding enzymatic activity.
10926147|NCT00691132|OG001|Outcome|GSTT1 Present|GSTT1 Present: gene for glutathione-S-transferase (GST) T1 (GSTT1), present in one or both alleles, leading to a enzymatic activity.
10926148|NCT00691132|OG000|Outcome|GSTM1 and GSTT1 Both Genes Null|GSTM1 & GSTT1 Null: genes for glutathione-S-transferase (GST) M1 & T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.
10926149|NCT00691132|OG001|Outcome|GSTM1 and GSTT1 Only One Gene Present|GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.
10926150|NCT00691132|OG002|Outcome|GSTM1 and GSTT1 Both Genes Present|GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.
10926151|NCT00691132|EG000|Reported Event|Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
10926152|NCT00691132|EG001|Reported Event|Washout|9 days between treatments
10926153|NCT00691132|EG002|Reported Event|PEITC (Short-term Trial)|"Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
10926154|NCT00691197|BG000|Baseline|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
10926155|NCT00691197|BG001|Baseline|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
10926156|NCT00691197|BG002|Baseline|Total|Total of all reporting groups
10926157|NCT00691197|FG000|Participant Flow|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
10926158|NCT00691197|FG001|Participant Flow|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
10926159|NCT00691197|OG000|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
10926160|NCT00691197|OG001|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
10926161|NCT00691197|EG000|Reported Event|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
10926162|NCT00691197|EG001|Reported Event|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
10926163|NCT00691210|BG000|Baseline|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926164|NCT00691210|BG001|Baseline|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
11175527|NCT02029755|EG001|Reported Event|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
10926165|NCT00691210|BG002|Baseline|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926166|NCT00691210|BG003|Baseline|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926167|NCT00691210|BG004|Baseline|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926168|NCT00691210|BG005|Baseline|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926169|NCT00691210|BG006|Baseline|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926170|NCT00691210|BG007|Baseline|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926171|NCT00691210|BG008|Baseline|Total|Total of all reporting groups
10926172|NCT00691210|FG000|Participant Flow|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926173|NCT00691210|FG001|Participant Flow|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926174|NCT00691210|FG002|Participant Flow|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926175|NCT00691210|FG003|Participant Flow|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926176|NCT00691210|FG004|Participant Flow|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926177|NCT00691210|FG005|Participant Flow|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926178|NCT00691210|FG006|Participant Flow|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926179|NCT00691210|FG007|Participant Flow|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926180|NCT00691210|OG000|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926181|NCT00691210|OG001|Outcome|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926182|NCT00691210|OG002|Outcome|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926183|NCT00691210|OG003|Outcome|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926184|NCT00691210|OG004|Outcome|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926185|NCT00691210|OG005|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926186|NCT00691210|OG006|Outcome|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926187|NCT00691210|OG000|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1-5|"Vorinostat: 400mg Niacinamide: 20-100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926188|NCT00691210|OG001|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1-2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25-50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926189|NCT00691210|EG000|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926190|NCT00691210|EG001|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926191|NCT00691210|EG002|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926192|NCT00691210|EG003|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926193|NCT00691210|EG004|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
10926194|NCT00691210|EG005|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926195|NCT00691210|EG006|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
10926196|NCT00691301|BG000|Baseline|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
10926197|NCT00691301|FG000|Participant Flow|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
10926198|NCT00691301|OG000|Outcome|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
10926199|NCT00691301|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10926200|NCT00691301|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10926201|NCT00691301|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10926202|NCT00691301|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10926203|NCT00691301|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10926204|NCT00691301|OG005|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10926205|NCT00691301|EG000|Reported Event|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
10926206|NCT00691327|BG000|Baseline|Reconstruction|Women who have undergone Breast Reconstruction
10926207|NCT00691327|BG001|Baseline|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
10926208|NCT00691327|BG002|Baseline|Total|Total of all reporting groups
10926209|NCT00691327|FG000|Participant Flow|Reconstruction|Women who have undergone Breast Reconstruction
10926210|NCT00691327|FG001|Participant Flow|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
10926211|NCT00691327|OG000|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
10926212|NCT00691327|OG001|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
10926213|NCT00691327|EG000|Reported Event|Reconstruction|Women who have undergone Breast Reconstruction
10926214|NCT00691327|EG001|Reported Event|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
10926215|NCT00691483|BG000|Baseline|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
10926216|NCT00691483|BG001|Baseline|Placebo|Placebo matched to varenicline.
10926217|NCT00691483|BG002|Baseline|Total|Total of all reporting groups
10926218|NCT00691483|FG000|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
10926219|NCT00691483|FG001|Participant Flow|Placebo|Placebo matched to varenicline.
10926220|NCT00691483|OG000|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
10926221|NCT00691483|OG001|Outcome|Placebo|Placebo matched to varenicline.
10926222|NCT00691483|EG000|Reported Event|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
10926223|NCT00691483|EG001|Reported Event|Placebo|Placebo matched to varenicline.
10926224|NCT00691600|BG000|Baseline|Oral Trimethoprim/Sulfamethoxazole|"subjects with abscesses less than 5cm will be randomized to study medication, oral trimethoprim/sulfamethoxazole:~80 mg caps or 8 mg/ml suspension every 12 hours for 10 days"
10926225|NCT00691600|BG001|Baseline|Placebo After Incision and Drainage|"Patients with abscesses less than 5cm will be randomized to receive placebo.~Placebo: Placebo capsules every 12 hours for 10 days"
10926226|NCT00691600|BG002|Baseline|Total|Total of all reporting groups
10926227|NCT00691600|FG000|Participant Flow|Antibiotic Arm|subjects with abscesses less than 5cm will be randomized to oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
10926228|NCT00691600|FG001|Participant Flow|Placebo Arm|Patients with abscesses < 5cm randomized to placebo tablets or suspension twice a day for 10 days
10926229|NCT00691600|OG000|Outcome|Antibiotic Arm|oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
10926230|NCT00691600|OG001|Outcome|Placebo Arm|Receipt of placebo in either capsule or suspension formulation twice daily for 10 days
10926231|NCT00691600|EG000|Reported Event|Antibiotic Arm|subjects with abscesses less than 5cm who received oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
10926232|NCT00691600|EG001|Reported Event|Placebo Arm|subjects with abscesses less than 5cm who received placebo capsules or suspension every 12 hours for 10 days
10926233|NCT00691665|BG000|Baseline|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
10926234|NCT00691665|BG001|Baseline|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
10926235|NCT00691665|BG002|Baseline|Total|Total of all reporting groups
10926236|NCT00691665|FG000|Participant Flow|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
10926237|NCT00691665|FG001|Participant Flow|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
10926238|NCT00691665|OG000|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
10926239|NCT00691665|OG001|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
10926240|NCT00691665|EG000|Reported Event|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
11175528|NCT02029755|EG002|Reported Event|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
10926241|NCT00691665|EG001|Reported Event|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
10926242|NCT00691704|BG000|Baseline|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Maintenance Therapy: Subjects who achieve >partial response (PR) after induction will receive repeating triplet 28-day cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance:~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on Days 1-7~Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21."
10926243|NCT00691704|FG000|Participant Flow|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
10926244|NCT00691704|OG000|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
11192047|NCT02136420|OG000|Outcome|Perceptual Thresholds,Drug Then Placebo|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.~Promethazine: Subject receives promethazine~Placebo: Placebo"
10926245|NCT00691704|EG000|Reported Event|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
10926246|NCT00691808|BG000|Baseline|High Dose|240 mg LX6171 oral suspension administered once per day
10926247|NCT00691808|BG001|Baseline|Low Dose|120 mg LX6171 oral suspension administered once per day
10926248|NCT00691808|BG002|Baseline|Placebo|Placebo dosing volume-matched and administered once per day
10926249|NCT00691808|BG003|Baseline|Total|Total of all reporting groups
10926250|NCT00691808|FG000|Participant Flow|High Dose|240 mg LX6171 oral suspension administered once per day
10926251|NCT00691808|FG001|Participant Flow|Low Dose|120 mg LX6171 oral suspension administered once per day
10926252|NCT00691808|FG002|Participant Flow|Placebo|Placebo dosing volume-matched and administered once per day
10926253|NCT00691808|OG000|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
10926254|NCT00691808|OG001|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
10926255|NCT00691808|OG002|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
10926256|NCT00691808|EG000|Reported Event|High Dose|240 mg LX6171 oral suspension administered once per day
10926257|NCT00691808|EG001|Reported Event|Low Dose|120 mg LX6171 oral suspension administered once per day
10926258|NCT00691808|EG002|Reported Event|Placebo|Placebo dosing volume-matched and administered once per day
10926259|NCT00691938|BG000|Baseline|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926260|NCT00691938|BG001|Baseline|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926261|NCT00691938|BG002|Baseline|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926262|NCT00691938|BG003|Baseline|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926263|NCT00691938|BG004|Baseline|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926264|NCT00691938|BG005|Baseline|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926265|NCT00691938|BG006|Baseline|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926266|NCT00691938|BG007|Baseline|Total|Total of all reporting groups
10926267|NCT00691938|FG000|Participant Flow|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926268|NCT00691938|FG001|Participant Flow|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926269|NCT00691938|FG002|Participant Flow|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926270|NCT00691938|FG003|Participant Flow|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926271|NCT00691938|FG004|Participant Flow|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926272|NCT00691938|FG005|Participant Flow|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926273|NCT00691938|FG006|Participant Flow|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926274|NCT00691938|OG000|Outcome|Phase I (Includes Levels 1-5)|
10926275|NCT00691938|OG000|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
10926276|NCT00691938|EG000|Reported Event|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926277|NCT00691938|EG001|Reported Event|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926278|NCT00691938|EG002|Reported Event|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926279|NCT00691938|EG003|Reported Event|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926280|NCT00691938|EG004|Reported Event|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926281|NCT00691938|EG005|Reported Event|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926282|NCT00691938|EG006|Reported Event|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
10926283|NCT00692185|BG000|Baseline|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.
10926284|NCT00692185|BG001|Baseline|Placebo|Participants will take matched placebo for 8 weeks.
10926285|NCT00692185|BG002|Baseline|Total|Total of all reporting groups
10926286|NCT00692185|FG000|Participant Flow|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.
10926287|NCT00692185|FG001|Participant Flow|Placebo|Participants will take matched placebo for 8 weeks.
10926288|NCT00692185|OG000|Outcome|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.
10926289|NCT00692185|OG001|Outcome|Placebo|Participants will take matched placebo for 8 weeks.Dosing of placebo began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg . All subjects received 8 weeks of assigned medication.
10926290|NCT00692185|OG000|Outcome|Olanzapine|"Participants will take olanzapine.~Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication"
10926291|NCT00692185|OG001|Outcome|Placebo|"Participants will take matched placebo.~Placebo: Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks."
11175529|NCT02029872|BG000|Baseline|Individual Alone|"Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
10926292|NCT00692185|EG000|Reported Event|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.
10926293|NCT00692185|EG001|Reported Event|Placebo|Participants will take matched placebo for 8 weeks.
10926294|NCT00692198|BG000|Baseline|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
10926295|NCT00692198|BG001|Baseline|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest).
10926296|NCT00692198|BG002|Baseline|Total|Total of all reporting groups
10926297|NCT00692198|FG000|Participant Flow|Supplemental Oxygen Therapy (LTOT)|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
10926298|NCT00692198|FG001|Participant Flow|No Supplemental Oxygen Therapy (No LTOT)|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
10926299|NCT00692198|OG000|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
10926300|NCT00692198|OG001|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
10926301|NCT00692198|EG000|Reported Event|Supplemental Oxygen Therapy|Participants will receive treatment with supplemental oxygen therapy. Supplemental oxygen therapy: oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep.
10926302|NCT00692198|EG001|Reported Event|Patients Crossing Over to Supplemental Oxygen Therapy|Participants in the No supplemental oxygen therapy group who receive supplemental oxygen therapy during their participation in the trial due to prescription of supplemental oxygen outside the trial or development of severe resting or exercise hypoxemia
10926303|NCT00692198|EG002|Reported Event|No Supplemental Oxygen|Participants in the No supplemental oxygen who did not receive home oxygen during their participation in the trial.
10926304|NCT00692211|BG000|Baseline|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
10926305|NCT00692211|BG001|Baseline|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
10926306|NCT00692211|BG002|Baseline|Total|Total of all reporting groups
10926307|NCT00692211|FG000|Participant Flow|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
10926308|NCT00692211|FG001|Participant Flow|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
10926309|NCT00692211|OG000|Outcome|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
10926310|NCT00692211|OG001|Outcome|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
10926311|NCT00692211|EG000|Reported Event|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
10926312|NCT00692211|EG001|Reported Event|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
10926313|NCT00692237|BG000|Baseline|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
10926314|NCT00692237|BG001|Baseline|Placebo|Placebo 100 mg/day (50 + 25 + 25)
10926315|NCT00692237|BG002|Baseline|Total|Total of all reporting groups
10926316|NCT00692237|FG000|Participant Flow|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
10926317|NCT00692237|FG001|Participant Flow|Placebo|Placebo 100 mg/day (50 + 25 + 25)
10926318|NCT00692237|OG000|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
10926319|NCT00692237|OG001|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
10926320|NCT00692237|EG000|Reported Event|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
10926321|NCT00692237|EG001|Reported Event|Placebo|Placebo 100 mg/day (50 + 25 + 25)
10926322|NCT00692276|BG000|Baseline|1 - Study Treatment|Superion™ Interspinous Spacer
10926323|NCT00692276|BG001|Baseline|2 - Active Control Treatment|X-STOP® IPD® Device
10926324|NCT00692276|BG002|Baseline|Total|Total of all reporting groups
10926325|NCT00692276|FG000|Participant Flow|1 - Study Treatment|"Interspinous Process Spacer Device~Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis"
10926326|NCT00692276|FG001|Participant Flow|2 - Active Control Treatment|"Interspinous Process Spacer Device~X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis"
10926327|NCT00692276|OG000|Outcome|1 - Study Treatment|"Interspinous Process Spacer Device~Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis"
10926328|NCT00692276|OG001|Outcome|2 - Active Control Treatment|"Interspinous Process Spacer Device~X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis"
10926329|NCT00692276|EG000|Reported Event|1 - Study Treatment|"Interspinous Process Spacer Device~Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis"
10926330|NCT00692276|EG001|Reported Event|2 - Active Control Treatment|"Interspinous Process Spacer Device~X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis"
10926331|NCT00692341|BG000|Baseline|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
10926332|NCT00692341|BG001|Baseline|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
10926333|NCT00692341|BG002|Baseline|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
10926334|NCT00692341|BG003|Baseline|Total|Total of all reporting groups
10926335|NCT00692341|FG000|Participant Flow|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
10926336|NCT00692341|FG001|Participant Flow|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
10926337|NCT00692341|FG002|Participant Flow|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
10926338|NCT00692341|OG000|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
10926339|NCT00692341|OG001|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
10926340|NCT00692341|OG002|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
10926341|NCT00692341|EG000|Reported Event|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
10926342|NCT00692341|EG001|Reported Event|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
10926343|NCT00692341|EG002|Reported Event|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
10926344|NCT00692406|BG000|Baseline|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
10926345|NCT00692406|FG000|Participant Flow|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
10926346|NCT00692406|OG000|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
10926347|NCT00692406|EG000|Reported Event|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
10926348|NCT00692419|BG000|Baseline|Symptom Management Intervention|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
10926349|NCT00692419|BG001|Baseline|Feedback Intervention|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
10926350|NCT00692419|BG002|Baseline|Total|Total of all reporting groups
10926351|NCT00692419|FG000|Participant Flow|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
11175530|NCT02029872|BG001|Baseline|Individual Plus Household|"Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
11175531|NCT02029872|BG002|Baseline|Total|Total of all reporting groups
11192048|NCT02136420|OG001|Outcome|Perceptual Thresholds,Placebo Then Drug|Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.
11192049|NCT02136420|EG000|Reported Event|Tilt Perception, Training, Placebo|
10926352|NCT00692419|FG001|Participant Flow|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
10926353|NCT00692419|OG000|Outcome|Management Arm Change in Pain Score|Management arm change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
10926354|NCT00692419|OG001|Outcome|Feedback Group - Change in Pain Score|Feedback group - change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
10926355|NCT00692419|OG002|Outcome|Management Group - Change in ED Score|Management group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
10926356|NCT00692419|OG003|Outcome|Feedback Group - Change in ED Score|Feedback group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
10926357|NCT00692419|OG004|Outcome|Management Group - Change in Depression Score|Management group - change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
10926358|NCT00692419|OG005|Outcome|Feedback Arm Change in Depression Score|Feedback arm change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
10926359|NCT00692419|EG000|Reported Event|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
10926360|NCT00692419|EG001|Reported Event|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
10926361|NCT00692692|BG000|Baseline|Both Arms|
10926362|NCT00692692|FG000|Participant Flow|DermaMatrix|experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
10926363|NCT00692692|FG001|Participant Flow|Standard of Care|standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
10926364|NCT00692692|OG000|Outcome|DermaMatrix|experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
10926365|NCT00692692|OG001|Outcome|Standard of Care|standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
10926366|NCT00692692|EG000|Reported Event|DermaMatrix|experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
10926367|NCT00692692|EG001|Reported Event|Standard of Care|standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
11192050|NCT02136420|EG001|Reported Event|Tilt Perception, No Training, Placebo|
10926368|NCT00692770|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
10926369|NCT00692770|BG001|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
10926370|NCT00692770|BG002|Baseline|Total|Total of all reporting groups
10926371|NCT00692770|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
10926372|NCT00692770|FG001|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
10926373|NCT00692770|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
10926374|NCT00692770|OG001|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
10926375|NCT00692770|OG000|Outcome|ANG-2 High Expression Group|ANG-2 high expression group included participants with the ANG-2 expression higher than 4009.765 pg/mL.
10926376|NCT00692770|OG001|Outcome|ANG-2 Low Expression Group|ANG-2 low expression group included participants with the ANG-2 expression lower than 4009.765 pg/mL.
10926377|NCT00692770|OG000|Outcome|AFP High Expression Group|AFP high expression group included participants with the AFP expression higher than 3.899 ng/mL.
10926378|NCT00692770|OG001|Outcome|AFP Low Expression Group|AFP low expression group included participants with the AFP expression lower than 3.899 ng/mL.
10926379|NCT00692770|OG000|Outcome|MET High Expression Group|MET high expression group included participants with the MET expression higher than 182.444 ng/mL.
10926380|NCT00692770|OG001|Outcome|MET Low Expression Group|MET low expression group included participants with the MET expression lower than 182.444 ng/mL.
10926381|NCT00692770|EG000|Reported Event|Placebo|Subjects received 2 tablets of placebo orally twice daily.
11192051|NCT02136420|EG002|Reported Event|Tilt Perception, Training, Promethazine|
11192052|NCT02136420|EG003|Reported Event|Tilt Perception, No Training, Promethazine|
10926382|NCT00692770|EG001|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Subjects received 2 tablets of Sorafenib [2*200 milligram (mg)] orally twice daily.
10926383|NCT00692978|BG000|Baseline|Asthma Patients|Recruited Asthma patients
10926384|NCT00692978|BG001|Baseline|Healthy Volunteers|Recruited healthy volunteers
10926385|NCT00692978|BG002|Baseline|Total|Total of all reporting groups
10926386|NCT00692978|FG000|Participant Flow|Asthma Patients|Monodisperse aerosols (MO) inhaled of Fluticasone Propionate (FP) 50micrograms dose
11175532|NCT02029872|FG000|Participant Flow|Individual Alone|"Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
11175533|NCT02029872|FG001|Participant Flow|Individual Plus Household|"Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
11175534|NCT02029872|OG000|Outcome|Individual Alone|"Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
11175535|NCT02029872|OG001|Outcome|Individual Plus Household|"Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
11175536|NCT02029872|EG000|Reported Event|Individual Alone|"Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
11175537|NCT02029872|EG001|Reported Event|Individual Plus Household|"Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
10926387|NCT00692978|FG001|Participant Flow|Healthy Volunteers|Monodisperse aerosols (MO) inhaled of Fluticasone Propionate (FP) 50micrograms dose
10926388|NCT00692978|OG000|Outcome|FP From Active 250 ug MDI Inhaler Asthma|Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler with Asthma participants
10926389|NCT00692978|OG001|Outcome|FP 50ug 1.5um Asthma|Monodisperse aerosols inhaled of Fluticasone Propionate 1.5 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
11175538|NCT02029911|BG000|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
11175539|NCT02029911|FG000|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
11175540|NCT02029911|OG000|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
10926390|NCT00692978|OG002|Outcome|FP 50ug 3um Asthma|Monodisperse aerosols inhaled of Fluticasone Propionate 3 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
10926391|NCT00692978|OG003|Outcome|FP 50ug 6um Asthma|Monodisperse aerosols inhaled of Fluticasone Propionate 6 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
10926392|NCT00692978|OG004|Outcome|FP From Active 250 ug MDI Inhaler HV|Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler with Healthy participants
10926393|NCT00692978|OG005|Outcome|FP 50ug 1.5um HV|Monodisperse aerosols inhaled of Fluticasone Propionate 1.5microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy volunteers
10926394|NCT00692978|OG006|Outcome|FP 50ug 3um HV|Monodisperse aerosols inhaled of Fluticasone Propionate 3microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy volunteers
10926395|NCT00692978|OG007|Outcome|FP 50ug 6um HV|Monodisperse aerosols inhaled of Fluticasone Propionate 3microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy volunteers
10926396|NCT00692978|EG000|Reported Event|FP From Active 250 ug MDI Inhaler Asthma|Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler with Asthma participants
10926397|NCT00692978|EG001|Reported Event|FP 50ug 1.5um Asthma|Monodisperse aerosols inhaled of Fluticasone Propionate 1.5 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
10926398|NCT00692978|EG002|Reported Event|FP 50ug 3um Asthma|Monodisperse aerosols inhaled of Fluticasone Propionate 3 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
10926399|NCT00692978|EG003|Reported Event|FP 50ug 6um Asthma|Monodisperse aerosols inhaled of Fluticasone Propionate 6 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
10926400|NCT00692978|EG004|Reported Event|FP From Active 250 ug MDI Inhaler Healthy|Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler with Healthy participants
10926401|NCT00692978|EG005|Reported Event|FP 50ug 1.5um Healthy|Monodisperse aerosols inhaled of Fluticasone Propionate 1.5 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy participants
10926402|NCT00692978|EG006|Reported Event|FP 50ug 3um Healthy|Monodisperse aerosols inhaled of Fluticasone Propionate 3 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy participants
10926403|NCT00692978|EG007|Reported Event|FP 50ug 6um Healthy|Monodisperse aerosols inhaled of Fluticasone Propionate 6 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy participants
10926404|NCT00693160|BG000|Baseline|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
10926405|NCT00693160|BG001|Baseline|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
10926406|NCT00693160|BG002|Baseline|Total|Total of all reporting groups
10926407|NCT00693160|FG000|Participant Flow|Intrathecal Ketorolac|"In the presence of a remifentanil infusion subjects received a single intrathecal injection of ketorolac 2 mg.~The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.~The remifentanil infusion was titrated based on the subjects' pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
10926408|NCT00693160|FG001|Participant Flow|Placebo Intrathecal Injection|"In the presence of remifentanil subjects received a single intrathecal injection of placebo (preservative-free normal saline).~The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.~The remifentanil infusion was titrated based on the subjects' pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
10926409|NCT00693160|OG000|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
10926410|NCT00693160|OG001|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
10926411|NCT00693160|EG000|Reported Event|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
10926412|NCT00693160|EG001|Reported Event|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
10963233|NCT00870896|EG000|Reported Event|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
10963234|NCT00871000|BG000|Baseline|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
10963235|NCT00871000|BG001|Baseline|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
10963236|NCT00871000|BG002|Baseline|Total|Total of all reporting groups
10963237|NCT00871000|FG000|Participant Flow|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
11175541|NCT02029911|EG000|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
10926413|NCT00693225|BG000|Baseline|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
10926414|NCT00693225|BG001|Baseline|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
10926415|NCT00693225|BG002|Baseline|Total|Total of all reporting groups
10926416|NCT00693225|FG000|Participant Flow|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
10926417|NCT00693225|FG001|Participant Flow|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
10926418|NCT00693225|OG000|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
10926419|NCT00693225|OG001|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
10926420|NCT00693225|EG000|Reported Event|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
10926421|NCT00693225|EG001|Reported Event|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
10926422|NCT00693303|BG000|Baseline|My Scrivener Training|Children received My Scrivenor training
10926423|NCT00693303|FG000|Participant Flow|My Scrivener Training|Subjects practiced writing letters and words for 20 minutes two times per week using the My Scrivenor device.
10926424|NCT00693303|OG000|Outcome|My Scrivener Training|Children received My Scrivenor training
10926425|NCT00693303|EG000|Reported Event|My Scrivener Training|Children received My Scrivenor training
10926426|NCT00693420|BG000|Baseline|Bimatoprost 0.03% Solution|
10926427|NCT00693420|BG001|Baseline|Vehicle Solution|
10926428|NCT00693420|BG002|Baseline|Total|Total of all reporting groups
10926429|NCT00693420|FG000|Participant Flow|Bimatoprost 0.03% Solution|
10926430|NCT00693420|FG001|Participant Flow|Vehicle Solution|
10926431|NCT00693420|OG000|Outcome|Bimatoprost 0.03% Solution|
10926432|NCT00693420|OG001|Outcome|Vehicle Solution|
10926433|NCT00693420|EG000|Reported Event|Bimatoprost 0.03% Solution|
10926434|NCT00693420|EG001|Reported Event|Vehicle Solution|
10926435|NCT00693472|BG000|Baseline|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
10926436|NCT00693472|BG001|Baseline|Part 1: Placebo|Placebo every 12 hours for 13 days
10926437|NCT00693472|BG002|Baseline|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
10926438|NCT00693472|BG003|Baseline|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
10926439|NCT00693472|BG004|Baseline|Total|Total of all reporting groups
10926440|NCT00693472|FG000|Participant Flow|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
10926441|NCT00693472|FG001|Participant Flow|Part 1: Placebo|Placebo every 12 hours for 13 days
10926442|NCT00693472|FG002|Participant Flow|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
10926443|NCT00693472|FG003|Participant Flow|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
11192053|NCT02136420|EG004|Reported Event|Perceptual Threshold Testing: Promethazine|
10926444|NCT00693472|OG000|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
10926445|NCT00693472|OG001|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
10926446|NCT00693472|OG000|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
10926447|NCT00693472|OG001|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
10926448|NCT00693472|EG000|Reported Event|Part 1: Placebo|Placebo every 12 hours for 13 days
10926449|NCT00693472|EG001|Reported Event|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
10926450|NCT00693472|EG002|Reported Event|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
10926451|NCT00693472|EG003|Reported Event|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
10926452|NCT00693485|BG000|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926453|NCT00693485|BG001|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926454|NCT00693485|BG002|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926455|NCT00693485|BG003|Baseline|Total|Total of all reporting groups
10926456|NCT00693485|FG000|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926457|NCT00693485|FG001|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926458|NCT00693485|FG002|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926459|NCT00693485|OG000|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926460|NCT00693485|OG001|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926461|NCT00693485|OG002|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926462|NCT00693485|EG000|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926463|NCT00693485|EG001|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
10926464|NCT00693485|EG002|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
11192054|NCT02136420|EG005|Reported Event|Perceptual Motion Threshold Testing: Placebo|
10926465|NCT00693498|BG000|Baseline|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
10926466|NCT00693498|BG001|Baseline|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
10926467|NCT00693498|BG002|Baseline|Total|Total of all reporting groups
10926468|NCT00693498|FG000|Participant Flow|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
10926469|NCT00693498|FG001|Participant Flow|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
10926470|NCT00693498|OG000|Outcome|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
10926471|NCT00693498|OG001|Outcome|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
10926472|NCT00693498|EG000|Reported Event|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
10926473|NCT00693498|EG001|Reported Event|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
10926474|NCT00693654|BG000|Baseline|Active|Active Medicated Lotion (Sarna)
10926475|NCT00693654|BG001|Baseline|Placebo|Placebo lotion (Cetaphil)
10926476|NCT00693654|BG002|Baseline|Total|Total of all reporting groups
10926477|NCT00693654|FG000|Participant Flow|Pramoxine Lotion|Active Medicated Pramoxine Lotion (Sarna) applied topically twice daily to areas of pruritus
10926478|NCT00693654|FG001|Participant Flow|Placebo Cetaphil Lotion|Placebo lotion (Cetaphil) applied twice daily to areas of pruritus
10926479|NCT00693654|OG000|Outcome|Active|Active Medicated Pramoxine Lotion (Sarna)
11175542|NCT02029976|BG000|Baseline|Attention Control Condition|Child and parent participants randomized to the attention control condition will receive a Newsletter Program or mailed monthly newsletter with general family-focused health information.
11192055|NCT02136420|EG006|Reported Event|Manual Control, Training, Placebo|
10926480|NCT00693654|OG001|Outcome|Placebo|Placebo lotion (Cetaphil)
10926481|NCT00693654|OG000|Outcome|Active|Active Medicated Lotion (Sarna)
10926482|NCT00693654|EG000|Reported Event|Active|Active Medicated Lotion (Sarna)
10926483|NCT00693654|EG001|Reported Event|Placebo|Placebo lotion (Cetaphil)
10926484|NCT00693693|BG000|Baseline|Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
10926485|NCT00693693|BG001|Baseline|Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
10926486|NCT00693693|BG002|Baseline|Lipocream|topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily
10926487|NCT00693693|BG003|Baseline|Total|Total of all reporting groups
10926488|NCT00693693|FG000|Participant Flow|Ointment|topical hydrocortisone 17-butyrate 0.1% preparation ointment
10926489|NCT00693693|FG001|Participant Flow|Lipocream|topical hydrocortisone 17-butyrate 0.1% preparation lipocream
10926490|NCT00693693|FG002|Participant Flow|Cream|topical hydrocortisone 17-butyrate 0.1% preparation cream
10926491|NCT00693693|OG000|Outcome|Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily to all areas of atopic dermatitis
10926492|NCT00693693|OG001|Outcome|Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily to all areas of atopic dermatitis
10926493|NCT00693693|OG002|Outcome|Lipocream|topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily to all areas of atopic dermatitis
10926494|NCT00693693|EG000|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
10926495|NCT00693693|EG001|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
10926496|NCT00693693|EG002|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Lipocream|topical hydrocortisone 17-butyrate 0.1% lipocream applied twice daily
10926497|NCT00693706|BG000|Baseline|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10926498|NCT00693706|BG001|Baseline|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10926499|NCT00693706|BG002|Baseline|Total|Total of all reporting groups
10926500|NCT00693706|FG000|Participant Flow|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10926501|NCT00693706|FG001|Participant Flow|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10926502|NCT00693706|OG000|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10926503|NCT00693706|OG001|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10926504|NCT00693706|EG000|Reported Event|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10926505|NCT00693706|EG001|Reported Event|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10926506|NCT00693719|BG000|Baseline|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
10926507|NCT00693719|FG000|Participant Flow|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
10926508|NCT00693719|OG000|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
10926509|NCT00693719|EG000|Reported Event|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
10926510|NCT00693784|BG000|Baseline|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
10926511|NCT00693784|FG000|Participant Flow|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
10926512|NCT00693784|OG000|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
10926513|NCT00693784|EG000|Reported Event|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
10926514|NCT00693992|BG000|Baseline|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
10926515|NCT00693992|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
10926516|NCT00693992|BG002|Baseline|Total|Total of all reporting groups
10926517|NCT00693992|FG000|Participant Flow|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
10926518|NCT00693992|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
10926519|NCT00693992|OG000|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
10926520|NCT00693992|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
10926521|NCT00693992|EG000|Reported Event|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
11175543|NCT02029976|BG001|Baseline|After School Weight Management Program|The 9-month after school weight management program called SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together), with a focus on healthy food and activity practices will be directed by a school nurse and will include: 1) quarterly parent/child coaching sessions with the school nurse held in the participant's home; 2) 14 child group sessions led by the school nurse, held in a school setting 1-2 times a month; 3) 5 parent group sessions led by a school nurse held in a school setting.
10926522|NCT00693992|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
11175544|NCT02029976|BG002|Baseline|Total|Total of all reporting groups
11175545|NCT02029976|FG000|Participant Flow|Attention Control Condition|Child and parent participants randomized to the attention control condition will receive a Newsletter Program or mailed monthly newsletter with general family-focused health information.
11192056|NCT02136420|EG007|Reported Event|Manual Control, No Training, Placebo|
10926523|NCT00694018|BG000|Baseline|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
10926524|NCT00694018|BG001|Baseline|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
10926525|NCT00694018|BG002|Baseline|Total|Total of all reporting groups
10926526|NCT00694018|FG000|Participant Flow|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
10926527|NCT00694018|FG001|Participant Flow|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
10926528|NCT00694018|OG000|Outcome|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
10926529|NCT00694018|OG001|Outcome|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
10926530|NCT00694018|EG000|Reported Event|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
10926531|NCT00694018|EG001|Reported Event|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
10926532|NCT00694070|BG000|Baseline|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
10926533|NCT00694070|FG000|Participant Flow|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
10926534|NCT00694070|OG000|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
10926535|NCT00694070|EG000|Reported Event|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
10926536|NCT00694096|BG000|Baseline|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
10926537|NCT00694096|FG000|Participant Flow|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
10926538|NCT00694096|OG000|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
10926539|NCT00694096|EG000|Reported Event|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
10926540|NCT00694109|BG000|Baseline|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
10926541|NCT00694109|FG000|Participant Flow|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
10926542|NCT00694109|OG000|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
10926543|NCT00694109|OG000|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) once a week subcutaneously for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
10926544|NCT00694109|EG000|Reported Event|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
10926545|NCT00694122|BG000|Baseline|All Study Participants|"Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied.~If the participant entered the study on NPH, NPH insulin given twice per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on once per day Lantus. Upon the second overnight visit, Lantus insulin and blood glucose outcomes was studied"
11175546|NCT02029976|FG001|Participant Flow|After School Weight Management Program|The 9-month after school weight management program called SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together), with a focus on healthy food and activity practices will be directed by a school nurse and will include: 1) quarterly parent/child coaching sessions with the school nurse held in the participant's home; 2) 14 child group sessions led by the school nurse, held in a school setting 1-2 times a month; 3) 5 parent group sessions led by a school nurse held in a school setting;
11175547|NCT02029976|OG000|Outcome|Attention Control Condition|Child and parent participants randomized to the attention control condition will receive a Newsletter Program or mailed monthly newsletter with general family-focused health information.
11175548|NCT02029976|OG001|Outcome|After School Weight Management Program|The 9-month after school weight management program called SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together), with a focus on healthy food and activity practices will be directed by a school nurse and will include: 1) quarterly parent/child coaching sessions with the school nurse held in the participant's home; 2) 14 child group sessions led by the school nurse, held in a school setting 1-2 times a month; 3) 5 parent group sessions led by a school nurse held in a school setting.
10926546|NCT00694122|FG000|Participant Flow|Lantus First, Then NPH|Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied
10926547|NCT00694122|FG001|Participant Flow|NPH First, Then Lantus|NPH was given twice per day in the first intervention period for 3-4 weeks and .Lantus was given once per day in second intervention period for 3-4 weeks.
10926548|NCT00694122|OG000|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
10926549|NCT00694122|OG001|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
10926550|NCT00694122|OG000|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
10926551|NCT00694122|OG001|Outcome|NPH Insulin|NPH was the given at 22:00 on the evening of the overnight admission.
11175549|NCT02029976|EG000|Reported Event|Attention Control Condition|Child and parent participants randomized to the attention control condition will receive a Newsletter Program or mailed monthly newsletter with general family-focused health information.
11192057|NCT02136420|EG008|Reported Event|Manual Control, Training, Promethazine|
11192058|NCT02136420|EG009|Reported Event|Manual Control, No Training, Promethazine|
10926552|NCT00694122|OG000|Outcome|Glargine (Lantus)|glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
10926553|NCT00694122|OG000|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given at 22:00 on the evening of the overnight admission.
10926554|NCT00694122|OG000|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission. .
10926555|NCT00694122|EG000|Reported Event|NPH Insulin|Individuals on NPH insuling as long acting insulin.
10926556|NCT00694122|EG001|Reported Event|Lantus Insulin|Individuals on Lantus insulin as long acting insulin.
10926557|NCT00694161|BG000|Baseline|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
10926558|NCT00694161|FG000|Participant Flow|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
10926559|NCT00694161|OG000|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
10926560|NCT00694161|EG000|Reported Event|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
10926561|NCT00694304|BG000|Baseline|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
10926562|NCT00694304|FG000|Participant Flow|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
10926563|NCT00694304|OG000|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
10926564|NCT00694304|EG000|Reported Event|Vortioxetine 2.5, 5, or 10 mg/Day|
10926565|NCT00694356|BG000|Baseline|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926566|NCT00694356|BG001|Baseline|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926567|NCT00694356|BG002|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926568|NCT00694356|BG003|Baseline|Total|Total of all reporting groups
10926569|NCT00694356|FG000|Participant Flow|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up.
10926570|NCT00694356|FG001|Participant Flow|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926571|NCT00694356|FG002|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926572|NCT00694356|OG000|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926573|NCT00694356|OG001|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926574|NCT00694356|OG002|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926575|NCT00694356|EG000|Reported Event|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926576|NCT00694356|EG001|Reported Event|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926577|NCT00694356|EG002|Reported Event|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
10926578|NCT00694473|BG000|Baseline|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
10926579|NCT00694473|FG000|Participant Flow|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
10926580|NCT00694473|OG000|Outcome|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
10926581|NCT00694473|EG000|Reported Event|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
10926582|NCT00694551|BG000|Baseline|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926583|NCT00694551|BG001|Baseline|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926584|NCT00694551|BG002|Baseline|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926585|NCT00694551|BG003|Baseline|Total|Total of all reporting groups
10926586|NCT00694551|FG000|Participant Flow|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926587|NCT00694551|FG001|Participant Flow|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926588|NCT00694551|FG002|Participant Flow|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926589|NCT00694551|OG000|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926590|NCT00694551|OG001|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926591|NCT00694551|OG002|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926592|NCT00694551|OG000|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926593|NCT00694551|EG000|Reported Event|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
11175550|NCT02029976|EG001|Reported Event|After School Weight Management Program|The 9-month after school weight management program called SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together), with a focus on healthy food and activity practices will be directed by a school nurse and will include: 1) quarterly parent/child coaching sessions with the school nurse held in the participant's home; 2) 14 child group sessions led by the school nurse, held in a school setting 1-2 times a month; 3) 5 parent group sessions led by a school nurse held in a school setting;
11192059|NCT02136498|BG000|Baseline|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
10926594|NCT00694551|EG001|Reported Event|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926595|NCT00694551|EG002|Reported Event|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
10926596|NCT00694564|BG000|Baseline|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
10926597|NCT00694564|FG000|Participant Flow|SAM-e|"This an open-labeled study. All participants received SAM-e.~S-adenosyl methionine : All participants received oral SAM-e which was initiated at a dose of 200 mg daily and escalated by 200 mg every week to a maximum dose of 1400 mg daily if patients did not report significant resolution of abdominal pain (defined as reduction in reported pain and to a maximum frequency of once weekly)."
10926598|NCT00694564|OG000|Outcome|SAM-e|"This an open-labeled study. All participants will receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
10926599|NCT00694564|EG000|Reported Event|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
10926600|NCT00694603|BG000|Baseline|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
10926601|NCT00694603|FG000|Participant Flow|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
10926602|NCT00694603|OG000|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
10926603|NCT00694603|EG000|Reported Event|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
10926604|NCT00694707|BG000|Baseline|Placebo|Participants received placebo orally once a day for 6 weeks.
10926605|NCT00694707|BG001|Baseline|Cariprazine 1.5 mg|Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
10926606|NCT00694707|BG002|Baseline|Cariprazine 3.0 mg|Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
10926607|NCT00694707|BG003|Baseline|Cariprazine 4.5 mg|Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
10926608|NCT00694707|BG004|Baseline|Risperidone 4.0 mg|Participants received risperidone 4.0 mg orally once a day for 6 weeks.
10926609|NCT00694707|BG005|Baseline|Total|Total of all reporting groups
10926610|NCT00694707|FG000|Participant Flow|Placebo|Participants received placebo orally once a day for 6 weeks.
10926611|NCT00694707|FG001|Participant Flow|Cariprazine 1.5 mg|Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
10926612|NCT00694707|FG002|Participant Flow|Cariprazine 3.0 mg|Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
10926613|NCT00694707|FG003|Participant Flow|Cariprazine 4.5 mg|Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
10926614|NCT00694707|FG004|Participant Flow|Risperidone 4.0 mg|Participants received risperidone 4.0 mg orally once a day for 6 weeks.
10926615|NCT00694707|OG000|Outcome|Placebo|Participants received placebo orally once a day for 6 weeks.
10926616|NCT00694707|OG001|Outcome|Cariprazine 1.5 mg|Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
10926617|NCT00694707|OG002|Outcome|Cariprazine 3.0 mg|Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
10926618|NCT00694707|OG003|Outcome|Cariprazine 4.5 mg|Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
10926619|NCT00694707|OG004|Outcome|Risperidone 4.0 mg|Participants received risperidone 4.0 mg orally once a day for 6 weeks.
10926620|NCT00694707|EG000|Reported Event|Placebo|Participants received placebo orally once a day for 6 weeks.
10926621|NCT00694707|EG001|Reported Event|Cariprazine 1.5 mg|Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
10926622|NCT00694707|EG002|Reported Event|Cariprazine 3.0 mg|Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
10926623|NCT00694707|EG003|Reported Event|Cariprazine 4.5 mg|Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
10926624|NCT00694707|EG004|Reported Event|Risperidone 4.0 mg|Participants received risperidone 4.0 mg orally once a day for 6 weeks.
10926625|NCT00695019|BG000|Baseline|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
10926626|NCT00695019|BG001|Baseline|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
10926627|NCT00695019|BG002|Baseline|Placebo|placebo lozenges taken 3 times per day
10926628|NCT00695019|BG003|Baseline|Total|Total of all reporting groups
10926629|NCT00695019|FG000|Participant Flow|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
10926630|NCT00695019|FG001|Participant Flow|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
10926631|NCT00695019|FG002|Participant Flow|Placebo|placebo lozenges taken 3 times per day
10926632|NCT00695019|OG000|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
10926633|NCT00695019|OG001|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
10926634|NCT00695019|OG002|Outcome|Placebo|placebo lozenges taken 3 times per day
10926635|NCT00695019|EG000|Reported Event|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
10926636|NCT00695019|EG001|Reported Event|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
10926637|NCT00695019|EG002|Reported Event|Placebo|placebo lozenges taken 3 times per day
10926638|NCT00695097|BG000|Baseline|Rituximab Group|Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed monthly for 1 year.
10926639|NCT00695097|BG001|Baseline|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only followed up monthly for 1 year.
10926640|NCT00695097|BG002|Baseline|Total|Total of all reporting groups
10926641|NCT00695097|FG000|Participant Flow|Rituximab Group|Rituximab Group: Rituximab dose is 1000 mg given as an IV infusion every 2 weeks (day 1 and 15) and followed monthly for 1 year.
10926642|NCT00695097|FG001|Participant Flow|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only and being followed monthly for 1 year.
10926643|NCT00695097|OG000|Outcome|Rituximab Group|Rituximab infusion day 1 and 15
10926644|NCT00695097|OG001|Outcome|Control Group|No Rituximab infusion
10926645|NCT00695097|EG000|Reported Event|Rituximab Group|Rituximab Group: Rituximab infusion day 1 and day 14.
10926646|NCT00695097|EG001|Reported Event|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only.
10926647|NCT00695110|BG000|Baseline|All Study Participants|"Repeat dose, sequential cross-over study including 4 treatment periods with a 7-14 day washout between successive periods:~Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.~Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.~Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting.~Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days."
10926648|NCT00695110|FG000|Participant Flow|All Study Participants|"Repeat dose, single-group study including 4 treatment periods with a 7-14 day washout between successive periods:~Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.~Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.~Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting.~Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days."
10926649|NCT00695110|OG000|Outcome|Treatment Period 1|Oral testosterone undecanoate (TU) (300 mg T equivalents/dose): Three capsules each containing 100 mg testosterone (T) as TU, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
10926650|NCT00695110|OG001|Outcome|Treatment Period 2|Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose): Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
10926651|NCT00695110|OG002|Outcome|Treatment Period 3|Oral testosterone undecanoate (TU) (200 mg T equivalents/dose) with and without food): Two capsules each containing 100 mg T as TU, BID for 8 days 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.
10926652|NCT00695110|OG003|Outcome|Treatment Period 4|Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose): Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
10926653|NCT00695110|EG000|Reported Event|All Study Participants|"Single group, repeat dose study including 4 treatment periods (7-8 days) and a 7-14 day washout between successive periods:~Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.~Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.~Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting.~Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.~The primary purpose of the study was to evaluate the pharmacokinetics of T following short-term, repeat-dose administration of various T doses in the form of TU or as a combination of TU + TE (7-8 days). Consequently, the AEs represent the integrated sum over all of the treatment groups in what was short-term T exposure compared to long-term efficacy and safety evaluations. Due to the short-term exposure to each intervention, changes in laboratory parameters were assessed at the end of the overall study and not the end of each treatment intervention."
10926654|NCT00695136|BG000|Baseline|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
10926655|NCT00695136|FG000|Participant Flow|Open Label Single Arm|"The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Those whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks. That ends their participation in the study.~Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a higher dose (2.5 mg) for 2 to 4 weeks. Those whose REM sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4 weeks. Children whose REM sleep does not increase to normal on 5 mg of donepezil stop the medication and end their participation in the study."
10926656|NCT00695136|OG000|Outcome|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
10926657|NCT00695136|EG000|Reported Event|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
10926658|NCT00695188|BG000|Baseline|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
10926659|NCT00695188|BG001|Baseline|High Dose|Start with 25 mg MTX per week, administered orally
10926660|NCT00695188|BG002|Baseline|Total|Total of all reporting groups
10926661|NCT00695188|FG000|Participant Flow|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
11192060|NCT02136498|BG001|Baseline|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
11192061|NCT02136498|BG002|Baseline|Total|Total of all reporting groups
10926662|NCT00695188|FG001|Participant Flow|High Dose|Start with 25 mg MTX per week, administered orally
10926663|NCT00695188|OG000|Outcome|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
10926664|NCT00695188|OG001|Outcome|High Dose|Start with 25 mg MTX per week, administered orally
10926665|NCT00695188|EG000|Reported Event|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
10926666|NCT00695188|EG001|Reported Event|High Dose|Start with 25 mg MTX per week, administered orally
10926667|NCT00695253|BG000|Baseline|There Are no Study Arms.|All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the inclusion/exclusion criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms.
10926668|NCT00695253|FG000|Participant Flow|Talent Endoluminal Spring Graft System|All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the inclusion/exclusion criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms.
10926669|NCT00695253|OG000|Outcome|Number of Successful Exclusion of Abdominal Aortic Aneurysms|The safety and effectiveness of the endoluminal device was determined by the number of abdominal aortic aneurysms (AAA) that were successfully excluded.
10926670|NCT00695253|OG000|Outcome|Number of Successful Device Delivery and Deployment|All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the entry criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms.
10926671|NCT00695253|EG000|Reported Event|Talent Endoluminal Spring Stent Graft System|Endoluminal treatment of abdominal aortic aneurysms using the Medtronic/Talent Stent Graft: Stent-graft for all patients with abdominal aortic lesions who signed consent into this Physician - Sponsored IDE.
10926672|NCT00695292|BG000|Baseline|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
10926673|NCT00695292|FG000|Participant Flow|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
10926674|NCT00695292|OG000|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
10926675|NCT00695292|EG000|Reported Event|Intervention|Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
10926676|NCT00695318|BG000|Baseline|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye"
10926677|NCT00695318|BG001|Baseline|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye"
10926678|NCT00695318|BG002|Baseline|Total|Total of all reporting groups
10926679|NCT00695318|FG000|Participant Flow|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day"
11192062|NCT02136498|FG000|Participant Flow|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
10926680|NCT00695318|FG001|Participant Flow|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day"
10926681|NCT00695318|OG000|Outcome|A, 2, I Sham|
10926682|NCT00695318|OG001|Outcome|A, 2, I 0.2 µg/Day|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day"
10926683|NCT00695318|OG002|Outcome|A, 2, II Sham|
10926684|NCT00695318|OG003|Outcome|A, 2, II 0.5 µg/Day|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day"
10926685|NCT00695318|EG000|Reported Event|Sham Injection|"Sham Injection~Sham Injection: Sham injection~Ocular AEs"
10926686|NCT00695318|EG001|Reported Event|0.2 ug/Day|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day~Ocular AEs"
10926687|NCT00695318|EG002|Reported Event|0.5 ug/Day|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day~Ocular AEs"
10926688|NCT00695318|EG003|Reported Event|0.2 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection~Systemic AEs"
10926689|NCT00695318|EG004|Reported Event|0.5 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection~Systemic AEs"
10926690|NCT00695396|BG000|Baseline|Placebo|(1ml or 2 mL) subcutaneously once every week
10926691|NCT00695396|BG001|Baseline|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
10926692|NCT00695396|BG002|Baseline|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
10926693|NCT00695396|BG003|Baseline|Total|Total of all reporting groups
10926694|NCT00695396|FG000|Participant Flow|Placebo|(1ml or 2 mL) subcutaneously once every week
10926695|NCT00695396|FG001|Participant Flow|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
10926696|NCT00695396|FG002|Participant Flow|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
10926697|NCT00695396|OG000|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
10926698|NCT00695396|OG001|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
10926699|NCT00695396|OG002|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
10926700|NCT00695396|EG000|Reported Event|Placebo|(1ml or 2 mL) subcutaneously once every week
10926701|NCT00695396|EG001|Reported Event|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
10926702|NCT00695396|EG002|Reported Event|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
10926703|NCT00695409|BG000|Baseline|Treatment (RIT, ZBEAM, ASCT)|"RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8*. NOTE: * Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~carmustine: Given IV~cytarabine: Given IV~etoposide: Given IV~melphalan: Given IV~ASCT: Undergo autologous peripheral blood stem cell transplant~yttrium Y 90 ibritumomab tiuxetan: Given IV"
10926704|NCT00695409|FG000|Participant Flow|Treatment (RIT, ZBEAM, ASCT)|"RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8*. NOTE: * Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~carmustine: Given IV~cytarabine: Given IV~etoposide: Given IV~melphalan: Given IV~ASCT: Undergo autologous peripheral blood stem cell transplant~yttrium Y 90 ibritumomab tiuxetan: Given IV"
10926705|NCT00695409|OG000|Outcome|Treatment (RIT, ZBEAM, ASCT)|"RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8*. NOTE: * Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~carmustine: Given IV~cytarabine: Given IV~etoposide: Given IV~melphalan: Given IV~ASCT: Undergo autologous peripheral blood stem cell transplant~yttrium Y 90 ibritumomab tiuxetan: Given IV"
10926706|NCT00695409|OG000|Outcome|Patients With Active Disease at ASCT|Patients receiving the full treatment (RIT/ZBEAM) with active disease at time of ASCT
10926707|NCT00695409|EG000|Reported Event|Treatment (RIT, ZBEAM, ASCT)|"RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8*. NOTE: * Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~carmustine: Given IV~cytarabine: Given IV~etoposide: Given IV~melphalan: Given IV~ASCT: Undergo autologous peripheral blood stem cell transplant~yttrium Y 90 ibritumomab tiuxetan: Given IV"
10926708|NCT00695435|BG000|Baseline|Overall Study|Overall Study
10926709|NCT00695435|FG000|Participant Flow|TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX|Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX
10926710|NCT00695435|FG001|Participant Flow|Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX|Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX
10926711|NCT00695435|FG002|Participant Flow|TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05%|Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05%
10926712|NCT00695435|OG000|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
10926713|NCT00695435|OG001|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
10926714|NCT00695435|OG002|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
10926715|NCT00695435|EG000|Reported Event|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
10926716|NCT00695435|EG001|Reported Event|TOBREX®|TOBREX® Ophthalmic Solution
10926717|NCT00695435|EG002|Reported Event|TOBRADEX®|TOBRADEX® Ophthalmic Suspension
10926718|NCT00695500|BG000|Baseline|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
10926719|NCT00695500|BG001|Baseline|Placebo|Placebo tablets, 0 mg per day for 3 weeks
10926720|NCT00695500|BG002|Baseline|Total|Total of all reporting groups
10926721|NCT00695500|FG000|Participant Flow|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
10926722|NCT00695500|FG001|Participant Flow|Placebo|Placebo tablets, 0 mg per day for 3 weeks
10926723|NCT00695500|OG000|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
10926724|NCT00695500|OG001|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
10926725|NCT00695500|EG000|Reported Event|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
10926726|NCT00695500|EG001|Reported Event|Placebo|Placebo tablets, 0 mg per day for 3 weeks
10926727|NCT00695565|BG000|Baseline|Placebo Gel|Placebo Gel is vehicle without clonidine
10926728|NCT00695565|BG001|Baseline|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
10926729|NCT00695565|BG002|Baseline|Total|Total of all reporting groups
10926730|NCT00695565|FG000|Participant Flow|Placebo Gel|Placebo Gel is vehicle without clonidine
10926731|NCT00695565|FG001|Participant Flow|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
10926732|NCT00695565|OG000|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
10926733|NCT00695565|OG001|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
10926734|NCT00695565|EG000|Reported Event|Placebo Gel|Placebo Gel is vehicle without clonidine
10926735|NCT00695565|EG001|Reported Event|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
10926736|NCT00695578|BG000|Baseline|Biafin on Left|"Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.~Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.~Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds"
10926737|NCT00695578|BG001|Baseline|Biafin on Right|"Subjects were randomized to apply Biafine® to wounds on the right forearm and polysporin (standard of care) to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.~Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.~Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds"
10926738|NCT00695578|BG002|Baseline|Total|Total of all reporting groups
10926739|NCT00695578|FG000|Participant Flow|Biafin on Left|"Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.~Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.~Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds"
10926740|NCT00695578|FG001|Participant Flow|Biafin on Right|"Subjects were randomized to apply Biafine® to wounds on the right forearm and polysporin (standard of care) to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.~Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.~Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds"
10926741|NCT00695578|OG000|Outcome|Biafine Treatment Group|"This group includes the forearm of the subjects that was randomized to apply Biafine® to wounds (either the left forearm or right forearm). Biafine was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.~Drug: Biafine Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.~Other Names:~• Biafine"
10926742|NCT00695578|OG001|Outcome|Polysporin Treatment Group|"This group includes the forearm of the subjects that was randomized to apply Polysporin (standard of care) to wounds (either the left forearm or right forearm). Polysporin was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.~Drug: Polysporin over the counter Polysporin ointment 3 times daily for 4 weeks to wounds~Other Names:~• Bacitracin"
10926743|NCT00695578|EG000|Reported Event|Biafin Treatment Group|"Experimental: Biafine Treatment Group~This group includes the forearm of the subjects that was randomized to apply Biafine® to wounds (either the left forearm or right forearm). Biafine was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.~Drug: Biafine Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.~Other Names:~• Biafine"
10926744|NCT00695578|EG001|Reported Event|Polysporin Treatment Group|"Active Comparator: Polysporin Treatment Group~This group includes the forearm of the subjects that was randomized to apply Polysporin (standard of care) to wounds (either the left forearm or right forearm). Polysporin was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.~Drug: Polysporin over the counter Polysporin ointment 3 times daily for 4 weeks to wounds~Other Names:~• Bacitracin"
10926745|NCT00695669|BG000|Baseline|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
11175551|NCT02029989|BG000|Baseline|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
10926746|NCT00695669|BG001|Baseline|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926747|NCT00695669|BG002|Baseline|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926748|NCT00695669|BG003|Baseline|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926749|NCT00695669|BG004|Baseline|Total|Total of all reporting groups
10926750|NCT00695669|FG000|Participant Flow|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926751|NCT00695669|FG001|Participant Flow|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926752|NCT00695669|FG002|Participant Flow|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926753|NCT00695669|FG003|Participant Flow|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926754|NCT00695669|OG000|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926755|NCT00695669|OG001|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926756|NCT00695669|OG002|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926757|NCT00695669|OG003|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
11175552|NCT02029989|BG001|Baseline|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
11175553|NCT02029989|BG002|Baseline|Total|Total of all reporting groups
11175554|NCT02029989|FG000|Participant Flow|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
10926758|NCT00695669|OG000|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926759|NCT00695669|OG000|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926760|NCT00695669|OG000|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926761|NCT00695669|EG000|Reported Event|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926762|NCT00695669|EG001|Reported Event|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926763|NCT00695669|EG002|Reported Event|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926764|NCT00695669|EG003|Reported Event|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
10926765|NCT00695786|BG000|Baseline|Other Histology|Other Histology
10926766|NCT00695786|BG001|Baseline|Follicular Lymphoma|Follicular Lymphoma
10926767|NCT00695786|BG002|Baseline|Marginal Zone Lymphoma|Marginal Zone Lymphoma
10926768|NCT00695786|BG003|Baseline|Small Lymphocytic Lymphoma|Small Lymphocytic Lymphoma
10926769|NCT00695786|BG004|Baseline|Total|Total of all reporting groups
10926770|NCT00695786|FG000|Participant Flow|Other Histology|Other Histology
10926771|NCT00695786|FG001|Participant Flow|Follicular Lymphoma|Follicular Lymphoma
10926772|NCT00695786|FG002|Participant Flow|Marginal Zone Lymphoma|Marginal Zone Lymphoma
10926773|NCT00695786|FG003|Participant Flow|Small Lymphocytic Lymphoma|Small Lymphocytic Lymphoma
10926774|NCT00695786|OG000|Outcome|Other Histology|Other Histology
10926775|NCT00695786|OG001|Outcome|Follicular Lymphoma|Follicular Lymphoma
10926776|NCT00695786|OG002|Outcome|Marginal Zone Lymphoma|Marginal Zone Lymphoma
10926777|NCT00695786|OG003|Outcome|Small Lymphocytic Lymphoma|Small Lymphocytic Lymphoma
10926778|NCT00695786|EG000|Reported Event|Other Histology|Other Histology
10926779|NCT00695786|EG001|Reported Event|Follicular Lymphoma|Follicular Lymphoma
10926780|NCT00695786|EG002|Reported Event|Marginal Zone Lymphoma|Marginal Zone Lymphoma
11175555|NCT02029989|FG001|Participant Flow|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
11192063|NCT02136498|FG001|Participant Flow|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
10926781|NCT00695786|EG003|Reported Event|Small Lymphocytic Lymphoma|Small Lymphocytic Lymphoma
10926782|NCT00695864|BG000|Baseline|Placebo Then Ondansetron|"Dosage and form:~Placebo - tablet Odansetron - 8 mg oral tablet~Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron."
10926783|NCT00695864|FG000|Participant Flow|Placebo Then Ondansetron|"Dosage and form:~Placebo - tablet Odansetron - 8 mg oral tablet~Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron."
10926784|NCT00695864|OG000|Outcome|Placebo - Sugar Pill|"Placebo - sugar pill~Ondansetron and Placebo crossover"
10926785|NCT00695864|OG001|Outcome|Ondansetron|"Ondansetron~Ondansetron and Placebo crossover"
10926786|NCT00695864|EG000|Reported Event|Placebo - Sugar Pill|"Placebo - sugar pill~Ondansetron and Placebo crossover"
10926787|NCT00695864|EG001|Reported Event|Ondansetron|"Ondansetron~Ondansetron and Placebo crossover"
10926788|NCT00695903|BG000|Baseline|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
10926789|NCT00695903|BG001|Baseline|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
10926790|NCT00695903|BG002|Baseline|Total|Total of all reporting groups
10926791|NCT00695903|FG000|Participant Flow|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
10926792|NCT00695903|FG001|Participant Flow|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
10926793|NCT00695903|OG000|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
10926794|NCT00695903|OG001|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
10926795|NCT00695903|EG000|Reported Event|Daptomycin|Daptomycin 10 mg/kg i.v.q24hr
10926796|NCT00695903|EG001|Reported Event|Vancomycin|Vancomycin 15 mg/kg i.v., dosed to maintain trough serum concentrations of 15 to 20 ug/mL
10926797|NCT00695955|BG000|Baseline|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.~Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
10926798|NCT00695955|FG000|Participant Flow|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.~Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
10926799|NCT00695955|OG000|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
10926800|NCT00695955|OG000|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
10926801|NCT00695955|EG000|Reported Event|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
10926802|NCT00695955|EG001|Reported Event|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
10926803|NCT00696020|BG000|Baseline|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926804|NCT00696020|BG001|Baseline|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926805|NCT00696020|BG002|Baseline|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926806|NCT00696020|BG003|Baseline|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926807|NCT00696020|BG004|Baseline|Total|Total of all reporting groups
10926808|NCT00696020|FG000|Participant Flow|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926809|NCT00696020|FG001|Participant Flow|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926810|NCT00696020|FG002|Participant Flow|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926811|NCT00696020|FG003|Participant Flow|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926812|NCT00696020|OG000|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926813|NCT00696020|OG001|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926814|NCT00696020|OG002|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926815|NCT00696020|OG003|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926816|NCT00696020|OG000|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926817|NCT00696020|OG001|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926818|NCT00696020|EG000|Reported Event|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926819|NCT00696020|EG001|Reported Event|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926820|NCT00696020|EG002|Reported Event|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926821|NCT00696020|EG003|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10926822|NCT00696072|BG000|Baseline|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg"
10926823|NCT00696072|BG001|Baseline|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
10926824|NCT00696072|BG002|Baseline|Total|Total of all reporting groups
10926825|NCT00696072|FG000|Participant Flow|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg Tablets, once daily up to 2 years. If a participant experienced intolerable toxicity related to dasatinib, they had the option to crossover to letrozole arm."
10926826|NCT00696072|FG001|Participant Flow|Letrozole|Participants received letrozole 2.5 mg tablets, once daily, up to 2 years. If the participant developed progressive disease while on the single agent, the participant had the option to add dasatinib to their treatment regimen.
10926827|NCT00696072|OG000|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
10926828|NCT00696072|OG001|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
10926829|NCT00696072|OG000|Outcome|Crossed Over From Letrozole to Letrozole + Dasatinib|These participants were randomized to receive letrozole 2.5 mg PO once daily. After developing progressive disease they continued letrozole, and were permitted to add 100 mg PO once daily dasatinib to their treatment regimen.
10926830|NCT00696072|EG000|Reported Event|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg"
10926831|NCT00696072|EG001|Reported Event|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
10926832|NCT00696137|BG000|Baseline|BEMA Fentanyl|"BEMA Fentanyl~BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily"
10926833|NCT00696137|FG000|Participant Flow|BEMA Fentanyl|"BEMA Fentanyl~BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily"
10926834|NCT00696137|OG000|Outcome|BEMA Fentanyl|"BEMA Fentanyl~BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily"
10926835|NCT00696137|EG000|Reported Event|BEMA Fentanyl|"BEMA Fentanyl~BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily"
10926836|NCT00696241|BG000|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
10926837|NCT00696241|BG001|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
10926838|NCT00696241|BG002|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
10926839|NCT00696241|BG003|Baseline|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
10926840|NCT00696241|BG004|Baseline|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
10926841|NCT00696241|BG005|Baseline|Total|Total of all reporting groups
10926842|NCT00696241|FG000|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
10926843|NCT00696241|FG001|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
10926844|NCT00696241|FG002|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
10926845|NCT00696241|FG003|Participant Flow|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
10926846|NCT00696241|FG004|Participant Flow|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
10926847|NCT00696241|OG000|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
10926848|NCT00696241|OG001|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
10926849|NCT00696241|OG002|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
10926850|NCT00696241|OG003|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
10926851|NCT00696241|OG004|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
10926852|NCT00696241|EG000|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
10926853|NCT00696241|EG001|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
10926854|NCT00696241|EG002|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
10926855|NCT00696241|EG003|Reported Event|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
10926856|NCT00696241|EG004|Reported Event|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
10926857|NCT00696293|BG000|Baseline|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
10926858|NCT00696293|FG000|Participant Flow|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
10926859|NCT00696293|OG000|Outcome|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
10926860|NCT00696293|OG000|Outcome|Duloxetine + Clinical Management|"Duloxetine + clinical management~NOTE -- THIS WORK WAS CONDUCTED AS PART OF A CAREER DEVELOPMENT AWARD. THE CLINICALTRIALS.GOV DESCRIPTION OF THE STUDY WAS UPDATED 1/5/16 TO UPDATE THE OPEN LABEL NATURE OF THIS WORK. THIS IS WHAT IS REPORTED HERE AND HAS BEEN PEER REVIEWED AND PUBLISHED.~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
10926861|NCT00696293|EG000|Reported Event|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
10926862|NCT00696384|BG000|Baseline|Azilsartan Medoxomil QD - Open Label Phase|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks. Study medication could have been up-titrated only after participant had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up or down-titrated by 1 dose level per scheduled or unscheduled visit. Baseline characteristics of this Open Label phase population are described in the table below.
10926863|NCT00696384|FG000|Participant Flow|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
10926864|NCT00696384|FG001|Participant Flow|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks.
10926865|NCT00696384|FG002|Participant Flow|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg, orally once daily or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
10926866|NCT00696384|OG000|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
10926867|NCT00696384|OG001|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
10926868|NCT00696384|OG000|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
10926869|NCT00696384|OG000|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed and other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
10926870|NCT00696384|EG000|Reported Event|Azilsartan Medoxomil QD - Open Label|"Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily.. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
10926871|NCT00696384|EG001|Reported Event|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil current dose (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other antihypertensive medications as needed for 6 weeks.
10926872|NCT00696384|EG002|Reported Event|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for up to 6 weeks.
10926873|NCT00696410|BG000|Baseline|Zinc Acetate|The intervention group consisted of patients with heart failure. Patients were given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
10926874|NCT00696410|BG001|Baseline|Controls|"The control group consistent of 10 persons without any known health conditions who provided laboratory samples at a single encounter to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls."
10926875|NCT00696410|BG002|Baseline|Total|Total of all reporting groups
10926876|NCT00696410|FG000|Participant Flow|Zinc Acetate|The intervention group consisted of patients with heart failure. Patients were given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
10926877|NCT00696410|FG001|Participant Flow|Control|"The control group consistent of 10 persons without any known health conditions who provided laboratory samples at a single encounter to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls."
10926878|NCT00696410|OG000|Outcome|CHF Patients With Zinc Acetate|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
10926879|NCT00696410|OG001|Outcome|Healthy Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup."
10926880|NCT00696410|OG000|Outcome|CHF Treated With Zinc Acetate|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months.
10926881|NCT00696410|OG001|Outcome|Health Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup."
10926882|NCT00696410|OG000|Outcome|CHF Patients With Zinc Acetate|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months.
10926883|NCT00696410|OG001|Outcome|Healthy Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls."
10926884|NCT00696410|OG001|Outcome|Health Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls."
10926885|NCT00696410|EG000|Reported Event|HF Group|The zinc intervention group consisted of patients with heart failure who were provided zinc acetate for 10 months
10926886|NCT00696410|EG001|Reported Event|Healthy Controls|"The control group consisted of 10 persons without any known health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls"
10926887|NCT00696423|BG000|Baseline|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
10926888|NCT00696423|BG001|Baseline|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix and one of Hiberix.
10926889|NCT00696423|BG002|Baseline|Total|Total of all reporting groups
10926890|NCT00696423|FG000|Participant Flow|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
10926891|NCT00696423|FG001|Participant Flow|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix and one of Hiberix.
10926892|NCT00696423|OG000|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
10926893|NCT00696423|OG001|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix and one of Hiberix.
10926894|NCT00696423|EG000|Reported Event|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
10926895|NCT00696423|EG001|Reported Event|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
10926896|NCT00696436|BG000|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
10926897|NCT00696436|BG001|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
10926898|NCT00696436|BG002|Baseline|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
10926899|NCT00696436|BG003|Baseline|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
10926900|NCT00696436|BG004|Baseline|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
10926901|NCT00696436|BG005|Baseline|Total|Total of all reporting groups
10926902|NCT00696436|FG000|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
10926903|NCT00696436|FG001|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
10926904|NCT00696436|FG002|Participant Flow|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
10926905|NCT00696436|FG003|Participant Flow|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
10926906|NCT00696436|FG004|Participant Flow|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
10926907|NCT00696436|OG000|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
10926908|NCT00696436|OG001|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
10926909|NCT00696436|OG002|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
10926910|NCT00696436|OG003|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
10926911|NCT00696436|OG004|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
10926912|NCT00696436|EG000|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
10926913|NCT00696436|EG001|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
10926914|NCT00696436|EG002|Reported Event|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
10926915|NCT00696436|EG003|Reported Event|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
10926916|NCT00696436|EG004|Reported Event|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
10926917|NCT00696449|BG000|Baseline|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
10926918|NCT00696449|BG001|Baseline|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
10926919|NCT00696449|BG002|Baseline|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
10926920|NCT00696449|BG003|Baseline|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
10926921|NCT00696449|BG004|Baseline|Total|Total of all reporting groups
10926922|NCT00696449|FG000|Participant Flow|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
10926923|NCT00696449|FG001|Participant Flow|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
10926924|NCT00696449|FG002|Participant Flow|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
10926925|NCT00696449|FG003|Participant Flow|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
10926926|NCT00696449|OG000|Outcome|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
10926927|NCT00696449|OG001|Outcome|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
10926928|NCT00696449|OG002|Outcome|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
10926929|NCT00696449|OG003|Outcome|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
10926930|NCT00696449|EG000|Reported Event|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
10926931|NCT00696449|EG001|Reported Event|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
10926932|NCT00696449|EG002|Reported Event|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
10926933|NCT00696449|EG003|Reported Event|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
10926934|NCT00696488|BG000|Baseline|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
10926935|NCT00696488|FG000|Participant Flow|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
10926936|NCT00696488|OG000|Outcome|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
11192064|NCT02136498|OG000|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
10926937|NCT00696488|EG000|Reported Event|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
10926938|NCT00696618|BG000|Baseline|Tap Water/Normosol-R/Fleet|"Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
10926939|NCT00696618|BG001|Baseline|Normosol-R/Fleet/Tap Water|"Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
10926940|NCT00696618|BG002|Baseline|Fleet/Tap Water/Normosol-R|"Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
10926941|NCT00696618|BG003|Baseline|Total|Total of all reporting groups
10926942|NCT00696618|FG000|Participant Flow|Tap Water/Normosol-R/Fleet|"Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
10926943|NCT00696618|FG001|Participant Flow|Normosol-R/Fleet/Tap Water|"Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
10926944|NCT00696618|FG002|Participant Flow|Fleet/Tap Water/Normosol-R|"Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
10926945|NCT00696618|OG000|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
11192065|NCT02136498|OG001|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
10926946|NCT00696618|OG001|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
10926947|NCT00696618|OG002|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
10926948|NCT00696618|EG000|Reported Event|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
10926949|NCT00696618|EG001|Reported Event|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
10926950|NCT00696618|EG002|Reported Event|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
10926951|NCT00696657|BG000|Baseline|Placebo|Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926952|NCT00696657|BG001|Baseline|Semaglutide 0.1 mg|Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926953|NCT00696657|BG002|Baseline|Semaglutide 0.2 mg|Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926954|NCT00696657|BG003|Baseline|Semaglutide 0.4 mg|Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
11175556|NCT02029989|OG000|Outcome|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
11192066|NCT02136498|EG000|Reported Event|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
10926955|NCT00696657|BG004|Baseline|Semaglutide 0.8 mg|Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926956|NCT00696657|BG005|Baseline|Semaglutide 0.8 mg (With Titration)|Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926957|NCT00696657|BG006|Baseline|Semaglutide 1.6 mg (With Titration)|Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926958|NCT00696657|BG007|Baseline|Liraglutide 1.2 mg|Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926959|NCT00696657|BG008|Baseline|Liraglutide 1.8 mg|Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926960|NCT00696657|BG009|Baseline|Total|Total of all reporting groups
10926961|NCT00696657|FG000|Participant Flow|Placebo|Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected subcutaneously (s.c.; under the skin) in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926962|NCT00696657|FG001|Participant Flow|Semaglutide 0.1 mg|Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926963|NCT00696657|FG002|Participant Flow|Semaglutide 0.2 mg|Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926964|NCT00696657|FG003|Participant Flow|Semaglutide 0.4 mg|Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926965|NCT00696657|FG004|Participant Flow|Semaglutide 0.8 mg|Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926966|NCT00696657|FG005|Participant Flow|Semaglutide 0.8 mg (With Titration)|Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926967|NCT00696657|FG006|Participant Flow|Semaglutide 1.6 mg (With Titration)|Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926968|NCT00696657|FG007|Participant Flow|Liraglutide 1.2 mg|Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926969|NCT00696657|FG008|Participant Flow|Liraglutide 1.8 mg|Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926970|NCT00696657|OG000|Outcome|Placebo|Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926971|NCT00696657|OG001|Outcome|Semaglutide 0.1 mg|Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926972|NCT00696657|OG002|Outcome|Semaglutide 0.2 mg|Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926973|NCT00696657|OG003|Outcome|Semaglutide 0.4 mg|Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926974|NCT00696657|OG004|Outcome|Semaglutide 0.8 mg|Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926975|NCT00696657|OG005|Outcome|Semaglutide 0.8 mg (With Titration)|Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926976|NCT00696657|OG006|Outcome|Semaglutide 1.6 mg (With Titration)|Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926977|NCT00696657|OG007|Outcome|Liraglutide 1.2 mg|Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926978|NCT00696657|OG008|Outcome|Liraglutide 1.8 mg|Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
11192067|NCT02136498|EG001|Reported Event|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
10926979|NCT00696657|EG000|Reported Event|Placebo|Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926980|NCT00696657|EG001|Reported Event|Semaglutide 0.1 mg|Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926981|NCT00696657|EG002|Reported Event|Semaglutide 0.2 mg|Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926982|NCT00696657|EG003|Reported Event|Semaglutide 0.4 mg|Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926983|NCT00696657|EG004|Reported Event|Semaglutide 0.8 mg|Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926984|NCT00696657|EG005|Reported Event|Semaglutide 0.8 mg (With Titration)|Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11-week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926985|NCT00696657|EG006|Reported Event|Semaglutide 1.6 mg (With Titration)|Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926986|NCT00696657|EG007|Reported Event|Liraglutide 1.2 mg|Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926987|NCT00696657|EG008|Reported Event|Liraglutide 1.8 mg|Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
10926988|NCT00696696|BG000|Baseline|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
10926989|NCT00696696|FG000|Participant Flow|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
10926990|NCT00696696|OG000|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
10926991|NCT00696696|EG000|Reported Event|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
10926992|NCT00696709|BG000|Baseline|Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine|Participants received an 0.65 mL subcutaneous injection of heat-treated VZV vaccine A; 4-dose regimen administered ~30 days apart.
10926993|NCT00696709|BG001|Baseline|Part 1: Gamma-Irradiated VZV Vaccine A|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart.
10926994|NCT00696709|BG002|Baseline|Part 1: Placebo|Participants received a 4-dose placebo regimen administered ~30 days apart.
10926995|NCT00696709|BG003|Baseline|Part 2: Gamma-Irradiated VZV Vaccine B|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart.
10926996|NCT00696709|BG004|Baseline|Part 2: Gamma-Irradiated VZV Vaccine C|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered ~30 days apart.
10926997|NCT00696709|BG005|Baseline|Total|Total of all reporting groups
10926998|NCT00696709|FG000|Participant Flow|Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine|Participants received an 0.65 mL subcutaneous injection of heat-treated VZV vaccine A; 4-dose regimen administered ~30 days apart.
10926999|NCT00696709|FG001|Participant Flow|Part 1: Gamma-Irradiated VZV Vaccine A|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart.
10927000|NCT00696709|FG002|Participant Flow|Part 1: Placebo|Participants received a 4-dose placebo regimen administered ~30 days apart.
10927001|NCT00696709|FG003|Participant Flow|Part 2: Gamma-Irradiated VZV Vaccine B|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart.
10927002|NCT00696709|FG004|Participant Flow|Part 2: Gamma-Irradiated VZV Vaccine C|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered ~30 days apart.
10927003|NCT00696709|OG000|Outcome|Part 1: Gamma- Irradiated VZV Vaccine A|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart.
10927004|NCT00696709|OG000|Outcome|Part 2: Gamma-Irradiated VZV Vaccine B|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart.
10927005|NCT00696709|OG000|Outcome|Part 2: Gamma-Irradiated VZV Vaccine C|Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart.
10927006|NCT00696709|OG000|Outcome|Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine|Participants received an 0.65 mL subcutaneous injection of heat-treated VZV vaccine A; 4-dose regimen administered ~30 days apart.
10927007|NCT00696709|OG001|Outcome|Part 1: Gamma-Irradiated VZV Vaccine A|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart.
10927008|NCT00696709|OG002|Outcome|Part 1: Placebo|Participants received a 4-dose placebo regimen administered ~30 days apart.
10927009|NCT00696709|OG003|Outcome|Part 2: Gamma-Irradiated VZV Vaccine B|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart.
10927010|NCT00696709|OG004|Outcome|Part 2: Gamma-Irradiated VZV Vaccine C|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered ~30 days apart.
10927011|NCT00696709|OG001|Outcome|Part 1: Gamma-Irradiated VZV Vaccine A|Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart
11175557|NCT02029989|OG001|Outcome|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
10927012|NCT00696709|EG000|Reported Event|Part 1 Heat-treated VZV Vaccine|Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart.
10927013|NCT00696709|EG001|Reported Event|Gamma-irradiated VZV Vaccine A|Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart.
10927014|NCT00696709|EG002|Reported Event|Placebo|Participants received a 4-dose placebo regimen administered ~30 days apart.
10927015|NCT00696709|EG003|Reported Event|Part 2 Gamma-irradiated VZV Vaccine B|Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart.
10927016|NCT00696709|EG004|Reported Event|Gamma-irradiated VZV Vaccine C|Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart.
10927017|NCT00696761|BG000|Baseline|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
10927018|NCT00696761|BG001|Baseline|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
10927019|NCT00696761|BG002|Baseline|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
10927020|NCT00696761|BG003|Baseline|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
10927021|NCT00696761|BG004|Baseline|Total|Total of all reporting groups
10927022|NCT00696761|FG000|Participant Flow|BOOI≥20, BCI≥ 100|"Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100~alfuzosin : 10mg, once daily, 12months"
10927023|NCT00696761|FG001|Participant Flow|BOOI≥20, BCI< 100|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
10927024|NCT00696761|FG002|Participant Flow|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
10927025|NCT00696761|FG003|Participant Flow|BOOI<20, BCI< 100|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
10927026|NCT00696761|OG000|Outcome|BOOI≥ 20, BCI≥100|"Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
10927027|NCT00696761|OG001|Outcome|BOOI≥ 20, BCI<100|"BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
10927028|NCT00696761|OG002|Outcome|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
10927029|NCT00696761|OG003|Outcome|BOOI<20, BCI<100|"BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12 months"
10927030|NCT00696761|OG000|Outcome|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
10927031|NCT00696761|OG001|Outcome|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
10927032|NCT00696761|OG002|Outcome|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
10927033|NCT00696761|OG003|Outcome|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
10927034|NCT00696761|OG000|Outcome|group1|"Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~Alfuzosin: 10mg, once daily, 12months"
10927035|NCT00696761|OG001|Outcome|group2|"BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~Alfuzosin: 10mg, once daily, 12months"
10927036|NCT00696761|OG002|Outcome|Group 3|"BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~Alfuzosin: 10mg, once daily, 12months"
10927037|NCT00696761|OG003|Outcome|Group 4|"BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~Alfuzosin: 10mg, once daily, 12months"
10927038|NCT00696761|EG000|Reported Event|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
10927039|NCT00696761|EG001|Reported Event|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
10927040|NCT00696761|EG002|Reported Event|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
10927041|NCT00696761|EG003|Reported Event|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
10927042|NCT00696774|BG000|Baseline|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
10927043|NCT00696774|BG001|Baseline|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
10927044|NCT00696774|BG002|Baseline|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
10927045|NCT00696774|BG003|Baseline|Total|Total of all reporting groups
10927046|NCT00696774|FG000|Participant Flow|Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
10927047|NCT00696774|FG001|Participant Flow|Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
10927048|NCT00696774|FG002|Participant Flow|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
10927049|NCT00696774|OG000|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
10927050|NCT00696774|OG001|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
10927051|NCT00696774|OG000|Outcome|Duloxetine|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks. Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
11192068|NCT02136576|BG000|Baseline|Sensodyne|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study."
10927052|NCT00696774|EG000|Reported Event|Duloxetine Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
10927053|NCT00696774|EG001|Reported Event|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
10927054|NCT00696774|EG002|Reported Event|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
10927055|NCT00696787|BG000|Baseline|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
10927056|NCT00696787|BG001|Baseline|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
10927057|NCT00696787|BG002|Baseline|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
10927058|NCT00696787|BG003|Baseline|Total|Total of all reporting groups
10927059|NCT00696787|FG000|Participant Flow|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
10927060|NCT00696787|FG001|Participant Flow|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
10927061|NCT00696787|FG002|Participant Flow|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
10927062|NCT00696787|OG000|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
10927063|NCT00696787|OG001|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
10927064|NCT00696787|OG002|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
10927065|NCT00696787|EG000|Reported Event|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
10927066|NCT00696787|EG001|Reported Event|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
10927067|NCT00696787|EG002|Reported Event|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
10927068|NCT00697073|BG000|Baseline|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
10927069|NCT00697073|FG000|Participant Flow|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
10927070|NCT00697073|OG000|Outcome|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
10927071|NCT00697073|EG000|Reported Event|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
10927072|NCT00697112|BG000|Baseline|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
10927073|NCT00697112|FG000|Participant Flow|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
10927074|NCT00697112|OG000|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
10927075|NCT00697112|EG000|Reported Event|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
10927076|NCT00697190|BG000|Baseline|All Completed Subjects|All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town.
10927077|NCT00697190|FG000|Participant Flow|Senofilcon A/Galyfilcon A|senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
10927078|NCT00697190|FG001|Participant Flow|Galyfilcon A/Senofilcon A|galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
10927079|NCT00697190|OG000|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
10927080|NCT00697190|OG001|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
10927081|NCT00697190|OG000|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
10927082|NCT00697190|OG001|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
10927083|NCT00697190|OG000|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
10927084|NCT00697190|OG001|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
10927085|NCT00697190|EG000|Reported Event|Senofilcon A|senofilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
10927086|NCT00697190|EG001|Reported Event|Galyfilcon A|galyfilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
10927087|NCT00697203|BG000|Baseline|Dalcetrapib 300mg|"Pravastatin: 40mg po daily for 12 weeks~dalcetrapib: 300mg po daily for 12 weeks"
10927088|NCT00697203|BG001|Baseline|Dalcetrapib 600mg|"Pravastatin: 40mg po daily for 12 weeks~dalcetrapib: 600mg po daily for 12 weeks"
10927089|NCT00697203|BG002|Baseline|Dalcetrapib 900mg|"Pravastatin: 40mg po daily for 12 weeks~dalcetrapib: 900mg po daily for 12 weeks"
10927090|NCT00697203|BG003|Baseline|Placebo|"Placebo: po daily for 12 weeks~Pravastatin: 40mg po daily for 12 weeks"
10927091|NCT00697203|BG004|Baseline|Total|Total of all reporting groups
10927092|NCT00697203|FG000|Participant Flow|Dalcetrapib 300mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 300mg po daily for 12 weeks"
10927093|NCT00697203|FG001|Participant Flow|Dalcetrapib 600mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 600mg po daily for 12 weeks"
10927094|NCT00697203|FG002|Participant Flow|Dalcetrapib 900mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 900mg po daily for 12 weeks"
10927095|NCT00697203|FG003|Participant Flow|Placebo|"Placebo: po daily for 12 weeks~Pravastatin: 40mg po daily for 12 weeks"
10927096|NCT00697203|OG000|Outcome|Dalcetrapib 300mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 300mg po daily for 12 weeks"
10927097|NCT00697203|OG001|Outcome|Dalcetrapib 600mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 600mg po daily for 12 weeks"
10927098|NCT00697203|OG002|Outcome|Dalcetrapib 900mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 900mg po daily for 12 weeks"
10927099|NCT00697203|OG003|Outcome|Placebo|"Placebo: po daily for 12 weeks~Pravastatin: 40mg po daily for 12 weeks"
10927100|NCT00697203|EG000|Reported Event|Dalcetrapib 300mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 300mg po daily for 12 weeks"
10927101|NCT00697203|EG001|Reported Event|Dalcetrapib 600mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 600mg po daily for 12 weeks"
10927102|NCT00697203|EG002|Reported Event|Dalcetrapib 900mg|"Pravastatin: 40mg po daily for 12 weeks~Dalcetrapib: 900mg po daily for 12 weeks"
10927103|NCT00697203|EG003|Reported Event|Placebo|"Placebo: po daily for 12 weeks~Pravastatin: 40mg po daily for 12 weeks"
10927104|NCT00697346|BG000|Baseline|Part 1: PIC Dose Escalation|Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
10927105|NCT00697346|BG001|Baseline|Part 1: ECT Dose Escalation|Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
10927106|NCT00697346|BG002|Baseline|Part 2: PTCL|Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10927107|NCT00697346|BG003|Baseline|Total|Total of all reporting groups
10927108|NCT00697346|FG000|Participant Flow|Part 1: PIC Dose Escalation|Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
10927109|NCT00697346|FG001|Participant Flow|Part 1: ECT Dose Escalation|Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
10927110|NCT00697346|FG002|Participant Flow|Part 2: PTCL|Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10927111|NCT00697346|OG000|Outcome|Alisertib 25mg PIC QD 21D|Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927112|NCT00697346|OG001|Outcome|Alisertib 35 mg PIC QD 21D|Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927113|NCT00697346|OG002|Outcome|Alisertib 35 mg PIC QD 14D|Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927114|NCT00697346|OG003|Outcome|Alisertib 45 mg PIC QD 14D|Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927115|NCT00697346|OG004|Outcome|Alisertib 65 mg PIC QD 14D|Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927116|NCT00697346|OG005|Outcome|Alisertib 90 mg PIC QD 14D|Alisertib 90 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927117|NCT00697346|OG006|Outcome|Alisertib 40 mg ECT QD 14D|Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927118|NCT00697346|OG007|Outcome|Alisertib 30 mg ECT BID 7D|Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927119|NCT00697346|OG008|Outcome|Alisertib 40 mg ECT BID 7D|alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927120|NCT00697346|OG009|Outcome|Alisertib 50 mg ECT BID 7D|Alisertib 50 mg ECT, orally BID for 7 Ddays followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10963238|NCT00871000|FG001|Participant Flow|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
10927121|NCT00697346|OG000|Outcome|Alisertib|Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927122|NCT00697346|OG000|Outcome|Alisertib 35 mg PIC QD 14D|Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927123|NCT00697346|OG001|Outcome|Alisertib 45 mg PIC QD 14D|Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927124|NCT00697346|OG002|Outcome|Alisertib 65 mg PIC QD 14D|Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927125|NCT00697346|OG003|Outcome|Alisertib 90 mg PIC QD 14D|Alisertib 90 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927126|NCT00697346|OG000|Outcome|Alisertib 40 mg ECT QD 14D|Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927127|NCT00697346|OG000|Outcome|Alisertib 30 mg ECT BID 7D|Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927128|NCT00697346|OG001|Outcome|Alisertib 40 mg ECT BID 7D|alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927129|NCT00697346|OG002|Outcome|Alisertib 50 mg ECT BID 7D|Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
10927130|NCT00697346|OG000|Outcome|Part 1: PIC Dose Escalation|Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
10927131|NCT00697346|OG001|Outcome|Part 1: ECT Dose Escalation|Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
10927132|NCT00697346|OG002|Outcome|Part 2: PTCL|Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10927133|NCT00697346|EG000|Reported Event|Part 1 PIC Dose Escalation|Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
10927134|NCT00697346|EG001|Reported Event|Part 1 ECT Dose Escalation|Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
10927135|NCT00697346|EG002|Reported Event|Part 2 PTCL|Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
10927136|NCT00697463|BG000|Baseline|Women With Idiopathic Osteoporosis (IOP)|"Each subject will receive 20 micrograms of teriparatide subcutaneously daily.~Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18-24 months"
10927137|NCT00697463|FG000|Participant Flow|Women With Idiopathic Osteoporosis (IOP)|"Each subject will receive 20 micrograms of teriparatide subcutaneously daily.~Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18- 24 months"
10927138|NCT00697463|OG000|Outcome|Women With Idiopathic Osteoporosis (IOP)|"Each subject will receive 20 micrograms of teriparatide subcutaneously daily.~Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18-24 months"
10927139|NCT00697463|EG000|Reported Event|Women With Idiopathic Osteoporosis (IOP)|"Each subject will receive 20 micrograms of teriparatide subcutaneously daily.~Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18-24 months"
10927140|NCT00697515|BG000|Baseline|Entire Study Population|
10927141|NCT00697515|FG000|Participant Flow|SPD489 First|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
10927142|NCT00697515|FG001|Participant Flow|Placebo First|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
10927143|NCT00697515|OG000|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
10927144|NCT00697515|OG001|Outcome|Placebo|Placebo is administered once-daily
10927145|NCT00697515|EG000|Reported Event|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
10927146|NCT00697515|EG001|Reported Event|Placebo|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
10927147|NCT00697541|BG000|Baseline|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.~First intervention (1 day), washout (1 day), Second intervention (1 day)"
10927148|NCT00697541|BG001|Baseline|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically~First intervention (1 day), washout (1 day), Second intervention (1 day)"
10927149|NCT00697541|BG002|Baseline|Total|Total of all reporting groups
10927150|NCT00697541|FG000|Participant Flow|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.~First intervention (1 day), washout (1 day), Second intervention (1 day)"
10927151|NCT00697541|FG001|Participant Flow|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically~First intervention (1 day), washout (1 day), Second intervention (1 day)"
10927152|NCT00697541|OG000|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
10927153|NCT00697541|OG001|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
10927154|NCT00697541|OG000|Outcome|Treatment A - COL-118 Gel + Saline Drops|COL-118 gel + saline drops
10927155|NCT00697541|EG000|Reported Event|Treatment A|COL-118 gel + saline drops
10927156|NCT00697541|EG001|Reported Event|Treatment B|Vehicle gel + brimonidine drops
10927157|NCT00697593|BG000|Baseline|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
10927158|NCT00697593|FG000|Participant Flow|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
10927159|NCT00697593|OG000|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
10927160|NCT00697593|EG000|Reported Event|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
10927161|NCT00697619|BG000|Baseline|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
10927162|NCT00697619|BG001|Baseline|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
10927163|NCT00697619|BG002|Baseline|Total|Total of all reporting groups
10927164|NCT00697619|FG000|Participant Flow|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
10927165|NCT00697619|FG001|Participant Flow|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
10927166|NCT00697619|OG000|Outcome|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
10927167|NCT00697619|OG001|Outcome|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
10927168|NCT00697619|EG000|Reported Event|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
10927169|NCT00697619|EG001|Reported Event|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
10927170|NCT00697697|BG000|Baseline|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
10927171|NCT00697697|BG001|Baseline|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
10927172|NCT00697697|BG002|Baseline|Total|Total of all reporting groups
10927173|NCT00697697|FG000|Participant Flow|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
10927174|NCT00697697|FG001|Participant Flow|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
10927175|NCT00697697|OG000|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
10927176|NCT00697697|OG001|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
10927177|NCT00697697|EG000|Reported Event|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
10927178|NCT00697697|EG001|Reported Event|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
10927179|NCT00697788|BG000|Baseline|Ascending Dose Study|"Ascending doses of dexmedetomidine (as per protocol)~Dexmedetomidine: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5."
10927180|NCT00697788|FG000|Participant Flow|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes.
10927181|NCT00697788|FG001|Participant Flow|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dose and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study.
10927182|NCT00697788|FG002|Participant Flow|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2.
10927183|NCT00697788|FG003|Participant Flow|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3.
10927184|NCT00697788|FG004|Participant Flow|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4.
10927185|NCT00697788|FG005|Participant Flow|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5.
10927186|NCT00697788|FG006|Participant Flow|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6.
10927187|NCT00697788|FG007|Participant Flow|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7.
10927188|NCT00697788|OG000|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|
10927189|NCT00697788|OG001|Outcome|Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion|
10927190|NCT00697788|OG002|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|
10927191|NCT00697788|OG003|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|
10927192|NCT00697788|OG004|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|
10927193|NCT00697788|OG005|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|
10927194|NCT00697788|OG006|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|
10927195|NCT00697788|OG007|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|
10927196|NCT00697788|OG000|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|"Ascending doses of dexmedetomidine (as per protocol)~Dexmedetomidine: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5."
10927197|NCT00697788|OG000|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes.
10927198|NCT00697788|OG001|Outcome|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dexmedetomidine and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study.
10927199|NCT00697788|OG002|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2.
10927200|NCT00697788|OG003|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3.
10927201|NCT00697788|OG004|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4.
10927202|NCT00697788|OG005|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5.
10927203|NCT00697788|OG006|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6.
10927204|NCT00697788|OG007|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7.
10927205|NCT00697788|EG000|Reported Event|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus dose of 1 microgram/kilogram over 10 minutes IV
10927206|NCT00697788|EG001|Reported Event|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes
10927207|NCT00697788|EG002|Reported Event|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes
10927208|NCT00697788|EG003|Reported Event|Cohort 4: Dexmedetomidine 1.3 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr
10927209|NCT00697788|EG004|Reported Event|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes
10927210|NCT00697788|EG005|Reported Event|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes
10927211|NCT00697788|EG006|Reported Event|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes
10927212|NCT00697788|EG007|Reported Event|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes
10927213|NCT00697801|BG000|Baseline|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
10927214|NCT00697801|BG001|Baseline|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
10927215|NCT00697801|BG002|Baseline|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
10927216|NCT00697801|BG003|Baseline|Total|Total of all reporting groups
10927217|NCT00697801|FG000|Participant Flow|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
10927218|NCT00697801|FG001|Participant Flow|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
10927219|NCT00697801|FG002|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
10927220|NCT00697801|OG000|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
11192069|NCT02136576|BG001|Baseline|Crest Cavity Protection & MI Paste Plus|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Crest Cavity Protection & MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger."
10927221|NCT00697801|OG001|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
10927222|NCT00697801|OG002|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
10927223|NCT00697801|EG000|Reported Event|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
10927224|NCT00697801|EG001|Reported Event|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
10927225|NCT00697801|EG002|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
10927226|NCT00697827|BG000|Baseline|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
10927227|NCT00697827|BG001|Baseline|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
10927228|NCT00697827|BG002|Baseline|Total|Total of all reporting groups
10927229|NCT00697827|FG000|Participant Flow|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
10927230|NCT00697827|FG001|Participant Flow|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
10927231|NCT00697827|OG000|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
10927232|NCT00697827|OG001|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
10927233|NCT00697827|EG000|Reported Event|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
10927234|NCT00697827|EG001|Reported Event|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
10927235|NCT00698035|BG000|Baseline|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
10927236|NCT00698035|BG001|Baseline|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
10927237|NCT00698035|BG002|Baseline|Total|Total of all reporting groups
10927238|NCT00698035|FG000|Participant Flow|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
10927239|NCT00698035|FG001|Participant Flow|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
10927240|NCT00698035|OG000|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
10927241|NCT00698035|OG001|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
10927242|NCT00698035|OG000|Outcome|E2 by LC/MS|A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range <10 pg/ml)
10927243|NCT00698035|OG001|Outcome|E2 by RIA|Additional measurement of baseline and week 4 E2 by RIA
10927244|NCT00698035|OG000|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
10927245|NCT00698035|EG000|Reported Event|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
10927246|NCT00698035|EG001|Reported Event|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
10927247|NCT00698139|BG000|Baseline|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
10927248|NCT00698139|BG001|Baseline|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
10927249|NCT00698139|BG002|Baseline|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
10927250|NCT00698139|BG003|Baseline|Total|Total of all reporting groups
10927251|NCT00698139|FG000|Participant Flow|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
10927252|NCT00698139|FG001|Participant Flow|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
10927253|NCT00698139|FG002|Participant Flow|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
10927254|NCT00698139|OG000|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
10927255|NCT00698139|OG001|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
11175558|NCT02029989|EG000|Reported Event|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
10927256|NCT00698139|OG002|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
10927257|NCT00698139|EG000|Reported Event|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
10927258|NCT00698139|EG001|Reported Event|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
10927259|NCT00698139|EG002|Reported Event|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
10927260|NCT00698204|BG000|Baseline|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
10927261|NCT00698204|BG001|Baseline|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
10927262|NCT00698204|BG002|Baseline|Total|Total of all reporting groups
10927263|NCT00698204|FG000|Participant Flow|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
10927264|NCT00698204|FG001|Participant Flow|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
10927265|NCT00698204|OG000|Outcome|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
10927266|NCT00698204|OG001|Outcome|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
10927267|NCT00698204|OG000|Outcome|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
10927268|NCT00698204|OG001|Outcome|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
10927269|NCT00698204|EG000|Reported Event|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
10927270|NCT00698204|EG001|Reported Event|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
10927271|NCT00698451|BG000|Baseline|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
10927272|NCT00698451|FG000|Participant Flow|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
10927273|NCT00698451|OG000|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
10927274|NCT00698451|EG000|Reported Event|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
10927275|NCT00698516|BG000|Baseline|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
10927276|NCT00698516|FG000|Participant Flow|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
10927277|NCT00698516|OG000|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
10927278|NCT00698516|OG000|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
10927279|NCT00698516|OG001|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
11175559|NCT02029989|EG001|Reported Event|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
11175560|NCT02030002|BG000|Baseline|All Participants|This is a single-arm study. Participants receive both treatments at the same time. All participants are counted as one group at baseline.
11175561|NCT02030002|FG000|Participant Flow|All Participants|This is a single-arm, split-mouth study. Participants receive both treatments at the same time. Participants had APC Flash-Free Adhesive Appliance System on one side of their mouth and APCII Adhesive Appliance System on the other side. The side allocation was randomized as follows. A randomization scheme with equal distribution of the two side allocations was generated using the online randomization tool at http://www.graphpad.com/quickcalcs. Allocation concealment was achieved with sequentially numbered, opaque sealed envelopes (SNOSE) containing the side allocation of the adhesives, which were prepared before the trial. An independent third party was responsible for opening the next envelope in sequence and implementing the randomization process.
11175562|NCT02030002|OG000|Outcome|APC Flash-Free Adhesive Coated Appliance System|"APC Flash-Free Adhesive Coated Appliance System~APC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System"
11175563|NCT02030002|OG001|Outcome|APC II Adhesive Coated Appliance System|"APC II Adhesive Coated Appliance System~APC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System"
11175564|NCT02030002|EG000|Reported Event|APC Flash-Free Adhesive Coated Appliance System|"APC Flash-Free Adhesive Coated Appliance System~APC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System~Only the 45 participants who received treatment are included in the adverse event reporting."
11175565|NCT02030002|EG001|Reported Event|APC II Adhesive Coated Appliance System|"APC II Adhesive Coated Appliance System~APC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System~Only the 45 participants who received treatment are included in the adverse event reporting."
11175566|NCT02030041|BG000|Baseline|Simvastatin and Placebo|Participants took simvastatin 40 mg once daily and performed exercise for 12 weeks
11175567|NCT02030041|BG001|Baseline|Simvastatin and Vitamin D|Participants took simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
11175568|NCT02030041|BG002|Baseline|Vitamin D and Placebo|Participants took vitamin D 60000 units once weekly and performed exercise for 12 weeks
11175569|NCT02030041|BG003|Baseline|Total|Total of all reporting groups
11175570|NCT02030041|FG000|Participant Flow|Simvastatin and Placebo|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and placebo once weekly , and will exercise for twelve weeks
11175571|NCT02030041|FG001|Participant Flow|Simvastatin and Vitamin D|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and vitamin D 60000 units once weekly, and will exercise for twelve weeks
11175572|NCT02030041|FG002|Participant Flow|Vitamin D and Placebo|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks
11175573|NCT02030041|OG000|Outcome|Simvastatin and Placebo|Participants received simvastatin 40 mg once daily and performed exercise for 12 weeks
11175574|NCT02030041|OG001|Outcome|Simvastatin and Vitamin D|Participants received simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
11175575|NCT02030041|OG002|Outcome|Vitamin D and Placebo|Participants received vitamin D 60,000 units once weekly and performed exercise for 12 weeks
10927280|NCT00698516|OG002|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
10927281|NCT00698516|OG001|Outcome|Topotecan and Bevacizumab: Sensistive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
10927282|NCT00698516|EG000|Reported Event|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 mg/m^2/day for 5 consecutive days (Days 1 to 5) and IV bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GSK's study physician was needed for subjects who required treatment beyond 8 cycles.
10927283|NCT00698581|BG000|Baseline|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
10927284|NCT00698581|BG001|Baseline|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
10927285|NCT00698581|BG002|Baseline|Total Title|
10927286|NCT00698581|FG000|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
10927287|NCT00698581|FG001|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
10927288|NCT00698581|OG000|Outcome|Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
10927289|NCT00698581|OG000|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
10927290|NCT00698581|OG001|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
10927291|NCT00698581|EG000|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
10927292|NCT00698581|EG001|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
10927293|NCT00698646|BG000|Baseline|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
11175576|NCT02030041|EG000|Reported Event|Simvastatin and Placebo|"Eleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will exercise for twelve weeks~Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants~Placebo: Placebo will be provided to the study participants"
11192070|NCT02136576|BG002|Baseline|Clinpro 5000|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study."
10927294|NCT00698646|BG001|Baseline|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
10927295|NCT00698646|BG002|Baseline|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
10927296|NCT00698646|BG003|Baseline|Total|Total of all reporting groups
10927297|NCT00698646|FG000|Participant Flow|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
10927298|NCT00698646|FG001|Participant Flow|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
10927299|NCT00698646|FG002|Participant Flow|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
10927300|NCT00698646|OG000|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
10927301|NCT00698646|OG001|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
10927302|NCT00698646|OG002|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
11192071|NCT02136576|BG003|Baseline|Total|Total of all reporting groups
10927303|NCT00698646|EG000|Reported Event|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
10927304|NCT00698646|EG001|Reported Event|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
10927305|NCT00698646|EG002|Reported Event|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
10927306|NCT00698685|BG000|Baseline|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
10927307|NCT00698685|FG000|Participant Flow|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
10927308|NCT00698685|OG000|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
10927309|NCT00698685|EG000|Reported Event|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
10927310|NCT00698841|BG000|Baseline|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
10927311|NCT00698841|FG000|Participant Flow|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
10927312|NCT00698841|OG000|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
10927313|NCT00698841|EG000|Reported Event|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
10927314|NCT00698867|BG000|Baseline|Discovery™ Elbow|Discovery™ Elbow minimally constrained
10927315|NCT00698867|FG000|Participant Flow|Discovery™ Elbow|Discovery™ Elbow minimally constrained
10927316|NCT00698867|OG000|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
10927317|NCT00698867|EG000|Reported Event|Discovery™ Elbow|Discovery™ Elbow minimally constrained
10927318|NCT00698932|BG000|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
10927319|NCT00698932|BG001|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
10927320|NCT00698932|BG002|Baseline|Total|Total of all reporting groups
10927321|NCT00698932|FG000|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
10927322|NCT00698932|FG001|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
10927323|NCT00698932|OG000|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
10927324|NCT00698932|OG001|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
10927325|NCT00698932|EG000|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
10927326|NCT00698932|EG001|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
10927327|NCT00698997|BG000|Baseline|Early Start Denver Model|"Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching & coaching parents to use the ESDM in all natural caretaking routines & play periods with their child. Parents are taught & coached on 1 aspect of the ESDM each week in the clinic session, & then practice it at home daily in natural family routines & play.~Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines & play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week."
10927328|NCT00698997|BG001|Baseline|Standard Care Available in the Community|Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
10927329|NCT00698997|BG002|Baseline|Total|Total of all reporting groups
10963239|NCT00871000|OG000|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
10927330|NCT00698997|FG000|Participant Flow|1 Early Start Denver Model|"Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching & coaching parents to use the ESDM in all natural caretaking routines & play periods with their child. Parents are taught & coached on 1 aspect of the ESDM each week in the clinic session, & then practice it at home daily in natural family routines & play.~Phase 2: each child in the ESDM was assigned to receive 20 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years by trained interventionists (ITs). Parents delivered ESDM in natural family routines & play activities as they chose. In addition, children received additional public and or private services as their families chose.~Both phases followed published treatment manuals and all treatment was supervised by professionals with ESDM certification."
10927331|NCT00698997|FG001|Participant Flow|2 Standard Care Available in the Community|Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
10927332|NCT00698997|OG000|Outcome|1 Early Start Denver Model|"Early Start Denver Model: Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching & coaching parents to use the ESDM in all natural caretaking routines & play periods with their child. Parents are taught & coached on 1 aspect of the ESDM each week in the clinic session, & then practice it at home daily in natural family routines & play.~Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines & play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week."
10927333|NCT00698997|OG001|Outcome|Standard Care Available in the Community|Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
10927334|NCT00698997|OG001|Outcome|2Standard Care Available in the Community|"Standard Care available in the Community~Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD"
11175577|NCT02030041|EG001|Reported Event|Simvastatin and Vitamin D|"Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and vitamin D 60,000 units once weekly , and will exercise for twelve weeks~Vitamin D: Vitamin D will be given to achieve normal serum levels~Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants"
11175578|NCT02030041|EG002|Reported Event|Vitamin D and Placebo|"Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks~Vitamin D: Vitamin D will be given to achieve normal serum levels~Placebo: Placebo will be provided to the study participants"
11175579|NCT02030080|BG000|Baseline|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175580|NCT02030080|BG001|Baseline|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175581|NCT02030080|BG002|Baseline|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175582|NCT02030080|BG003|Baseline|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175583|NCT02030080|BG004|Baseline|Total|Total of all reporting groups
11175584|NCT02030080|FG000|Participant Flow|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175585|NCT02030080|FG001|Participant Flow|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175586|NCT02030080|FG002|Participant Flow|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11192072|NCT02136576|FG000|Participant Flow|Sensodyne|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study."
11240617|NCT02480764|OG000|Outcome|Azilsartan Medoxomil 40 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks.
10927335|NCT00698997|EG000|Reported Event|1 Early Start Denver Model|"Early Start Denver Model: Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching & coaching parents to use the ESDM in all natural caretaking routines & play periods with their child. Parents are taught & coached on 1 aspect of the ESDM each week in the clinic session, & then practice it at home daily in natural family routines & play.~Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines & play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week."
10927336|NCT00698997|EG001|Reported Event|Standard Care Available in the Community|Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
10927337|NCT00699010|BG000|Baseline|Acurox 5/30mg Taken First|Oxycodone HCL/Niacin 5/30mg; 8 tablet dose followed by Oxycodone 5mg with 48 hour washout
10927338|NCT00699010|BG001|Baseline|Oxycodone 5mg Taken First|Oxycodone HCL 5mg; 8 tablet dose followed by Acurox 5/30mg with 48 hour washout
10927339|NCT00699010|BG002|Baseline|Total|Total of all reporting groups
10927340|NCT00699010|FG000|Participant Flow|Acurox 5/30mg Taken First|Oxycodone HCl/Niacin 5/30mg; 8 tablet dose followed by oxycodone 5mg with 48 hour washout
10927341|NCT00699010|FG001|Participant Flow|Oxycodone 5mg Taken First|Oxycodone Hcl 5mg; 8 tablet dose follwed by Acurox 5/30mg with 48 hour washout
10927342|NCT00699010|OG000|Outcome|Acurox 5/30mg|Oxycodone HCL/Niacin 5/30mg; 8 tablet dose
10927343|NCT00699010|OG001|Outcome|Oxycodone 5mg|Oxycodone 5mg; 8 tablet dose
10927344|NCT00699010|EG000|Reported Event|Acurox 5/30mg|Oxycodone HCL/Niacin 5/30mg; 8 tablet dose
10927345|NCT00699010|EG001|Reported Event|Oxycodone 5mg|Oxycodone HCl 5mg; 8 tablet dose
10927346|NCT00699140|BG000|Baseline|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
10927347|NCT00699140|FG000|Participant Flow|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
10927348|NCT00699140|OG000|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
10927349|NCT00699140|OG000|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols. IGIV3I Grifols: Immune Globulin Intravenous (Human). All adverse events (AEs) are tabulated and summarized. Incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of MedDRA.~The frequency of patients and infusions associated with at least one AE are estimated as the primary safety endpoint."
10927350|NCT00699140|OG000|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
10927351|NCT00699140|OG000|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.~IGIV3I Grifols: Immune Globulin Intravenous (Human)"
10927352|NCT00699140|OG000|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
10927353|NCT00699140|EG000|Reported Event|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)"
10927354|NCT00699153|BG000|Baseline|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
10927355|NCT00699153|BG001|Baseline|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
10927356|NCT00699153|BG002|Baseline|Total|Total of all reporting groups
10927357|NCT00699153|FG000|Participant Flow|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
10927358|NCT00699153|FG001|Participant Flow|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
10927359|NCT00699153|OG000|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
10927360|NCT00699153|OG001|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
10927361|NCT00699153|EG000|Reported Event|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
10927362|NCT00699153|EG001|Reported Event|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
10927363|NCT00699192|BG000|Baseline|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
10927364|NCT00699192|BG001|Baseline|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
10927365|NCT00699192|BG002|Baseline|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
10927366|NCT00699192|BG003|Baseline|Total|Total of all reporting groups
10927367|NCT00699192|FG000|Participant Flow|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
10927368|NCT00699192|FG001|Participant Flow|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
10927369|NCT00699192|FG002|Participant Flow|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
10927370|NCT00699192|OG000|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
10927371|NCT00699192|OG001|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
10927372|NCT00699192|OG002|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
10927373|NCT00699192|EG000|Reported Event|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
10927374|NCT00699192|EG001|Reported Event|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
10927375|NCT00699192|EG002|Reported Event|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
10927376|NCT00699218|BG000|Baseline|Experimental|"Active rTMS treatment~Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks"
10927377|NCT00699218|FG000|Participant Flow|Experimental|"Active rTMS treatment~Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks"
10927378|NCT00699218|OG000|Outcome|Experimental|"Active rTMS treatment~Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks"
10927379|NCT00699218|EG000|Reported Event|rTMS Treatment|"Active rTMS treatment~Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks"
10927380|NCT00699283|BG000|Baseline|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
10927381|NCT00699283|BG001|Baseline|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
10927382|NCT00699283|BG002|Baseline|Total Title|
10927383|NCT00699283|FG000|Participant Flow|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
10927384|NCT00699283|FG001|Participant Flow|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
10927385|NCT00699283|OG000|Outcome|Efficacy Set (Brivaracetam 50 mg Treated Subjects)|"50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).~The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs."
10927386|NCT00699283|EG000|Reported Event|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
10927387|NCT00699283|EG001|Reported Event|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
10927388|NCT00699335|BG000|Baseline|Matrifen®|All patients enrolled
10927389|NCT00699335|FG000|Participant Flow|Matrifen®|All patients enrolled
10927390|NCT00699335|OG000|Outcome|Matrifen®|All patients with valid values at first and last visit
10927391|NCT00699335|OG000|Outcome|Matrifen®|All patients with valid values ('as observed')
10927392|NCT00699335|OG000|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
10927393|NCT00699335|OG001|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
10927394|NCT00699335|EG000|Reported Event|Matrifen®|Patients included and treated with at least one application of Matrifen®
10927395|NCT00699348|BG000|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
10927396|NCT00699348|FG000|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period [Week -4 to Week 0]) intravenous methoxy polyethylene glycolepoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
10927397|NCT00699348|OG000|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
10927398|NCT00699348|EG000|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
10927399|NCT00699374|BG000|Baseline|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
10927400|NCT00699374|BG001|Baseline|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
10927401|NCT00699374|BG002|Baseline|Total|Total of all reporting groups
10927402|NCT00699374|FG000|Participant Flow|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
10927403|NCT00699374|FG001|Participant Flow|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
10927404|NCT00699374|OG000|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
10927405|NCT00699374|OG001|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
10927406|NCT00699374|EG000|Reported Event|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
10927407|NCT00699374|EG001|Reported Event|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
10927408|NCT00699400|BG000|Baseline|Slow Freeze|Subjects that participated in one or more slow-freeze cycles
10927409|NCT00699400|BG001|Baseline|Vitrification|Subjects that participated in one or more vitrification cycles
10927410|NCT00699400|BG002|Baseline|Pre-Freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
10927411|NCT00699400|BG003|Baseline|Total|Total of all reporting groups
10927412|NCT00699400|FG000|Participant Flow|Slow Freeze (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
10927413|NCT00699400|FG001|Participant Flow|Slow Freeze (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
10927414|NCT00699400|FG002|Participant Flow|Vitrification (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
10927415|NCT00699400|FG003|Participant Flow|Vitrification (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
10927416|NCT00699400|FG004|Participant Flow|Both (Slow Freeze and Vitrification)|Participants who underwent both slow freezing and vitrification cycles (one cycle of each freezing technique).
10927417|NCT00699400|FG005|Participant Flow|Pre-freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
10927418|NCT00699400|OG000|Outcome|Slow Freezing|
10927419|NCT00699400|OG001|Outcome|Vitrification|
10927420|NCT00699400|OG002|Outcome|All Participants|
10927421|NCT00699400|EG000|Reported Event|Slow Freezing|
10927422|NCT00699400|EG001|Reported Event|Vitrification|
10927423|NCT00699400|EG002|Reported Event|All Participants|
10927424|NCT00699491|BG000|Baseline|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927425|NCT00699491|BG001|Baseline|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927426|NCT00699491|BG002|Baseline|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927427|NCT00699491|BG003|Baseline|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927428|NCT00699491|BG004|Baseline|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927429|NCT00699491|BG005|Baseline|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927430|NCT00699491|BG006|Baseline|Total|Total of all reporting groups
10927431|NCT00699491|FG000|Participant Flow|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927432|NCT00699491|FG001|Participant Flow|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927433|NCT00699491|FG002|Participant Flow|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927434|NCT00699491|FG003|Participant Flow|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927435|NCT00699491|FG004|Participant Flow|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927436|NCT00699491|FG005|Participant Flow|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927437|NCT00699491|OG000|Outcome|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927438|NCT00699491|OG001|Outcome|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927439|NCT00699491|OG002|Outcome|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927440|NCT00699491|OG003|Outcome|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927441|NCT00699491|OG004|Outcome|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927442|NCT00699491|OG000|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10927443|NCT00699491|EG000|Reported Event|Dose Level 1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10927444|NCT00699491|EG001|Reported Event|Dose Level -1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10927445|NCT00699491|EG002|Reported Event|Dose Level -2|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10927446|NCT00699491|EG003|Reported Event|Dose Level -2A|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10927447|NCT00699491|EG004|Reported Event|Dose Level -2B|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10927448|NCT00699491|EG005|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
10927449|NCT00699556|BG000|Baseline|Nicotine Patch + Nicotine Spray; Nicotine Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)~The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.~Or~Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale."
10927450|NCT00699556|FG000|Participant Flow|Nicotine Patch+Spray First, Then Nicotine Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)~The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.~Or~Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale."
11192073|NCT02136576|FG001|Participant Flow|Crest Cavity Protection & MI Paste Plus|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Crest Cavity Protection & MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger."
10927451|NCT00699556|FG001|Participant Flow|Nicotine Patch+Placebo Spray First, Then Nicotine Patch+Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)~The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.~Or~Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale."
10927452|NCT00699556|OG000|Outcome|Nicotine Patch+Nicotine Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol."
10927453|NCT00699556|OG001|Outcome|Nicotine Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital."
10927454|NCT00699556|OG000|Outcome|Nicotine Patch+ Nicotine Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol."
10927455|NCT00699556|EG000|Reported Event|Patch+Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol."
10927456|NCT00699556|EG001|Reported Event|Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital."
10963240|NCT00871000|OG001|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
10963241|NCT00871000|EG000|Reported Event|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
10963242|NCT00871000|EG001|Reported Event|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
10963243|NCT00871117|BG000|Baseline|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
10963244|NCT00871117|BG001|Baseline|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
10963245|NCT00871117|BG002|Baseline|Total|Total of all reporting groups
10963246|NCT00871117|FG000|Participant Flow|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
10963247|NCT00871117|FG001|Participant Flow|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
10963248|NCT00871117|OG000|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
10963249|NCT00871117|OG001|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
10963250|NCT00871117|OG001|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
10963251|NCT00871117|EG000|Reported Event|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm, and one dose of Varivax subcutaneously in the deltoid region of the right lower arm.
10927457|NCT00699582|BG000|Baseline|Placebo|
10927458|NCT00699582|BG001|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
10927459|NCT00699582|BG002|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
10927460|NCT00699582|BG003|Baseline|Total|Total of all reporting groups
10927461|NCT00699582|FG000|Participant Flow|Placebo|
10927462|NCT00699582|FG001|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
10927463|NCT00699582|FG002|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
10927464|NCT00699582|OG000|Outcome|Placebo|
10927465|NCT00699582|OG001|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
10927466|NCT00699582|OG002|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
10927467|NCT00699582|EG000|Reported Event|Placebo|
10927468|NCT00699582|EG001|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
10927469|NCT00699582|EG002|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
10927470|NCT00699608|BG000|Baseline|Entire Study Population|
10927471|NCT00699608|FG000|Participant Flow|Eszopiclone First, Zopiclone Second, Placebo Third|3 mg eszopiclone during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
10927472|NCT00699608|FG001|Participant Flow|Eszopiclone First, Placebo Second, Zopiclone Third|3 mg eszopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
10927473|NCT00699608|FG002|Participant Flow|Zopiclone First, Eszopiclone Second, Placebo Third|7.5 mg zopiclone during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
10927474|NCT00699608|FG003|Participant Flow|Zopiclone First, Placebo Second, Eszopiclone Third|7.5 mg zopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
10927475|NCT00699608|FG004|Participant Flow|Placebo First, Eszopiclone Second, Zopiclone Third|Placebo during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
10927476|NCT00699608|FG005|Participant Flow|Placebo First, Zopiclone Second, Eszopiclone Third|Placebo during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
10927477|NCT00699608|OG000|Outcome|Placebo|Placebo
10927478|NCT00699608|OG001|Outcome|Eszopiclone|3 mg Eszopiclone
10927479|NCT00699608|OG002|Outcome|Zopiclone|7.5 mg Zopiclone
10927480|NCT00699608|EG000|Reported Event|Placebo|Placebo
10927481|NCT00699608|EG001|Reported Event|Eszopiclone|3 mg Eszopiclone
10927482|NCT00699608|EG002|Reported Event|Zopiclone|7.5 mg Zopiclone
10927483|NCT00699660|BG000|Baseline|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
10927484|NCT00699660|BG001|Baseline|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
10927485|NCT00699660|BG002|Baseline|Total|Total of all reporting groups
10927486|NCT00699660|FG000|Participant Flow|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
10927487|NCT00699660|FG001|Participant Flow|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
10927488|NCT00699660|OG000|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
10927489|NCT00699660|OG001|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
10927490|NCT00699660|EG000|Reported Event|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
10927491|NCT00699660|EG001|Reported Event|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
10927492|NCT00699699|BG000|Baseline|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
10927493|NCT00699699|FG000|Participant Flow|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
10927494|NCT00699699|OG000|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
10927495|NCT00699699|EG000|Reported Event|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
10927496|NCT00699751|BG000|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
10927497|NCT00699751|BG001|Baseline|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
10927498|NCT00699751|BG002|Baseline|Total|Total of all reporting groups
10927499|NCT00699751|FG000|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received BSoC plus radium223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
10927500|NCT00699751|FG001|Participant Flow|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
10927501|NCT00699751|OG000|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
10927502|NCT00699751|OG001|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
10927503|NCT00699751|EG000|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Subjects received BSoC plus radium-223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
10927504|NCT00699751|EG001|Reported Event|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase.
10927505|NCT00699751|EG002|Reported Event|Placebo Randomized, Then Switched to Radium-223 Dichloride|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
10927506|NCT00699803|BG000|Baseline|T-Pred|"Tobramycin prednisolone acetate combination~T-PRED: sterile ophthalmic solution"
10927507|NCT00699803|BG001|Baseline|Pred Forte|"Prednisolone acetate~Pred Forte: sterile ophthalmic solution"
10927508|NCT00699803|BG002|Baseline|Total|Total of all reporting groups
10927509|NCT00699803|FG000|Participant Flow|T-Pred|"Tobramycin prednisolone acetate combination~T-PRED: sterile ophthalmic solution"
10927510|NCT00699803|FG001|Participant Flow|Pred Forte|"Prednisolone acetate~Pred Forte: sterile ophthalmic solution"
10927511|NCT00699803|OG000|Outcome|T-Pred|"Tobramycin prednisolone acetate combination~T-PRED: sterile ophthalmic solution"
10927512|NCT00699803|OG001|Outcome|Pred Forte|"Prednisolone acetate~T-PRED: sterile ophthalmic solution"
10927513|NCT00699803|EG000|Reported Event|T-Pred|"Tobramycin prednisolone acetate combination~T-PRED: sterile ophthalmic solution at the first time point~Pred Forte: sterile ophthalmic solution at the first time point"
10927514|NCT00699803|EG001|Reported Event|Pred Forte|"Prednisolone acetate~T-PRED: sterile ophthalmic solution at the second time point~Pred Forte: sterile ophthalmic solution at the second time point"
10927515|NCT00699816|BG000|Baseline|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
10927516|NCT00699816|BG001|Baseline|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
10927517|NCT00699816|BG002|Baseline|Total|Total of all reporting groups
10927518|NCT00699816|FG000|Participant Flow|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
10927519|NCT00699816|FG001|Participant Flow|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
10927520|NCT00699816|OG000|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
10927521|NCT00699816|OG001|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
10927522|NCT00699816|EG000|Reported Event|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
10927523|NCT00699816|EG001|Reported Event|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
10927524|NCT00699907|BG000|Baseline|Treatment Arm|"Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.~flutamide: Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity."
10927525|NCT00699907|BG001|Baseline|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
10927526|NCT00699907|BG002|Baseline|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
10927527|NCT00699907|BG003|Baseline|Total|Total of all reporting groups
10927528|NCT00699907|FG000|Participant Flow|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
10927529|NCT00699907|FG001|Participant Flow|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
10927530|NCT00699907|FG002|Participant Flow|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
10927531|NCT00699907|OG000|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
10927532|NCT00699907|OG001|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
10927533|NCT00699907|OG002|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
11175587|NCT02030080|FG003|Participant Flow|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175588|NCT02030080|OG000|Outcome|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
10927534|NCT00699907|EG000|Reported Event|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
10927535|NCT00699907|EG001|Reported Event|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
10927536|NCT00699907|EG002|Reported Event|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
10927537|NCT00699972|BG000|Baseline|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
10927538|NCT00699972|BG001|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
10927539|NCT00699972|BG002|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
10927540|NCT00699972|BG003|Baseline|Total|Total of all reporting groups
10927541|NCT00699972|FG000|Participant Flow|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
10927542|NCT00699972|FG001|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
10927543|NCT00699972|FG002|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
10927544|NCT00699972|OG000|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
10927545|NCT00699972|OG001|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
10927546|NCT00699972|OG002|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
10927547|NCT00699972|EG000|Reported Event|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
10927548|NCT00699972|EG001|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
10927549|NCT00699972|EG002|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
10927550|NCT00699998|BG000|Baseline|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
10927551|NCT00699998|BG001|Baseline|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
10927552|NCT00699998|BG002|Baseline|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
10927553|NCT00699998|BG003|Baseline|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
10927554|NCT00699998|BG004|Baseline|Total|Total of all reporting groups
10963252|NCT00871117|EG001|Reported Event|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
10927555|NCT00699998|FG000|Participant Flow|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
10927556|NCT00699998|FG001|Participant Flow|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study."
10927557|NCT00699998|FG002|Participant Flow|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
10927558|NCT00699998|FG003|Participant Flow|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
10927559|NCT00699998|OG000|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
10927560|NCT00699998|OG001|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
10927561|NCT00699998|OG002|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
10927562|NCT00699998|OG003|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
10927563|NCT00699998|OG000|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
10927564|NCT00699998|OG000|Outcome|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
10927565|NCT00699998|OG001|Outcome|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
10927566|NCT00699998|OG000|Outcome|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
10927567|NCT00699998|OG001|Outcome|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg orally, once daily as maintenance dose through end of study."
10927568|NCT00699998|OG002|Outcome|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study~Clopidogrel : 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
10927569|NCT00699998|OG003|Outcome|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
10927570|NCT00699998|EG000|Reported Event|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
10927571|NCT00699998|EG001|Reported Event|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
10927572|NCT00700011|BG000|Baseline|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
10927573|NCT00700011|BG001|Baseline|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
10927574|NCT00700011|BG002|Baseline|Total|Total of all reporting groups
10927575|NCT00700011|FG000|Participant Flow|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
10927576|NCT00700011|FG001|Participant Flow|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
11175589|NCT02030080|OG001|Outcome|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175590|NCT02030080|OG002|Outcome|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175591|NCT02030080|OG003|Outcome|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175592|NCT02030080|EG000|Reported Event|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175593|NCT02030080|EG001|Reported Event|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
10927577|NCT00700011|OG000|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
10927578|NCT00700011|OG001|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
10927579|NCT00700011|EG000|Reported Event|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
10927580|NCT00700011|EG001|Reported Event|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
10927581|NCT00700063|BG000|Baseline|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
10927582|NCT00700063|BG001|Baseline|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
10927583|NCT00700063|BG002|Baseline|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
10927584|NCT00700063|BG003|Baseline|4. Vehicle Gel|Two days treatment, day 1, 2
10927585|NCT00700063|BG004|Baseline|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
10927586|NCT00700063|BG005|Baseline|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
10927587|NCT00700063|BG006|Baseline|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
10927588|NCT00700063|BG007|Baseline|8. Vehicle Gel|Three days treatment, day 1, 2, 3
10927589|NCT00700063|BG008|Baseline|Total|Total of all reporting groups
10927590|NCT00700063|FG000|Participant Flow|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
10927591|NCT00700063|FG001|Participant Flow|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
10927592|NCT00700063|FG002|Participant Flow|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
10927593|NCT00700063|FG003|Participant Flow|4. Vehicle Gel|Two days treatment, day 1, 2
10927594|NCT00700063|FG004|Participant Flow|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
11175594|NCT02030080|EG002|Reported Event|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
10927595|NCT00700063|FG005|Participant Flow|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
10927596|NCT00700063|FG006|Participant Flow|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
10927597|NCT00700063|FG007|Participant Flow|8. Vehicle Gel|Three days treatment, day 1, 2, 3
10927598|NCT00700063|OG000|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
10927599|NCT00700063|OG001|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
10927600|NCT00700063|OG002|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
10927601|NCT00700063|OG003|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
10927602|NCT00700063|OG004|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
10927603|NCT00700063|OG005|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
10927604|NCT00700063|OG006|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
10927605|NCT00700063|OG007|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
10927606|NCT00700063|EG000|Reported Event|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
10927607|NCT00700063|EG001|Reported Event|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
10927608|NCT00700063|EG002|Reported Event|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
11175595|NCT02030080|EG003|Reported Event|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
11175596|NCT02030119|BG000|Baseline|Control|"The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
11175597|NCT02030119|BG001|Baseline|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
11175598|NCT02030119|BG002|Baseline|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
11175599|NCT02030119|BG003|Baseline|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
11175600|NCT02030119|BG004|Baseline|Total|Total of all reporting groups
11175601|NCT02030119|FG000|Participant Flow|Control|"The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
11175602|NCT02030119|FG001|Participant Flow|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
10927609|NCT00700063|EG003|Reported Event|4. Vehicle Gel|Two days treatment, day 1, 2
10927610|NCT00700063|EG004|Reported Event|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
10927611|NCT00700063|EG005|Reported Event|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
10927612|NCT00700063|EG006|Reported Event|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
10927613|NCT00700063|EG007|Reported Event|8. Vehicle Gel|Three days treatment, day 1, 2, 3
10927614|NCT00700102|BG000|Baseline|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed"
10927615|NCT00700102|BG001|Baseline|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed~Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
10927616|NCT00700102|BG002|Baseline|Total|Total of all reporting groups
10927617|NCT00700102|FG000|Participant Flow|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed"
10927618|NCT00700102|FG001|Participant Flow|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed~Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
10927619|NCT00700102|OG000|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
10927620|NCT00700102|OG001|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
10927621|NCT00700102|EG000|Reported Event|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
10927622|NCT00700102|EG001|Reported Event|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
10927623|NCT00700115|BG000|Baseline|Kaletra + Isentress|switched to Kaletra + Isentress
10927624|NCT00700115|BG001|Baseline|Standard HAART|Pre-study standard HAART regimen
10927625|NCT00700115|BG002|Baseline|Total|Total of all reporting groups
10927626|NCT00700115|FG000|Participant Flow|Kaletra + Isentress|Switched to Kaletra + Isentress
10927627|NCT00700115|FG001|Participant Flow|Standard HAART|Pre-study standard HAART regimen
10927628|NCT00700115|OG000|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
10927629|NCT00700115|OG001|Outcome|Standard HAART|Pre-study standard HAART regimen
10927630|NCT00700115|EG000|Reported Event|Kaletra + Isentress|switched to Kaletra + Isentress
10927631|NCT00700115|EG001|Reported Event|Standard HAART|Pre-study standard HAART regimen
10927632|NCT00700141|BG000|Baseline|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
10927633|NCT00700141|FG000|Participant Flow|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
10927634|NCT00700141|OG000|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
10927635|NCT00700141|EG000|Reported Event|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
10927636|NCT00700180|BG000|Baseline|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
10927637|NCT00700180|BG001|Baseline|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
10927638|NCT00700180|BG002|Baseline|Total|Total of all reporting groups
10927639|NCT00700180|FG000|Participant Flow|Bevacizumab 7.5 Milligrams (mg) Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg per kilogram (mg/kg) intravenously (IV) on Day 1; either carboplatin at a dose required to achieve an area under the concentration-time curve (AUC) of 6 mg per milliliter (mg/mL) IV and paclitaxel 200 mg per square meter (mg/m^2) IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
10927640|NCT00700180|FG001|Participant Flow|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
11175603|NCT02030119|FG002|Participant Flow|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
10927641|NCT00700180|OG000|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
10927642|NCT00700180|OG001|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
10927643|NCT00700180|EG000|Reported Event|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
10927644|NCT00700180|EG001|Reported Event|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
10927645|NCT00700271|BG000|Baseline|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
10927646|NCT00700271|BG001|Baseline|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
10927647|NCT00700271|BG002|Baseline|Total|Total of all reporting groups
10927648|NCT00700271|FG000|Participant Flow|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
10927649|NCT00700271|FG001|Participant Flow|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
10927650|NCT00700271|OG000|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
11192074|NCT02136576|FG002|Participant Flow|Clinpro 5000|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study."
10927651|NCT00700271|OG001|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
10927652|NCT00700271|EG000|Reported Event|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
10927653|NCT00700271|EG001|Reported Event|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
10927654|NCT00700310|BG000|Baseline|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
10927655|NCT00700310|BG001|Baseline|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
10927656|NCT00700310|BG002|Baseline|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
10927657|NCT00700310|BG003|Baseline|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
10927658|NCT00700310|BG004|Baseline|Total|Total of all reporting groups
10927659|NCT00700310|FG000|Participant Flow|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
10927660|NCT00700310|FG001|Participant Flow|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
10927661|NCT00700310|FG002|Participant Flow|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
10927662|NCT00700310|FG003|Participant Flow|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
10927663|NCT00700310|OG000|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
11175604|NCT02030119|FG003|Participant Flow|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
10927664|NCT00700310|OG001|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
10927665|NCT00700310|OG002|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
10927666|NCT00700310|OG003|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
10927667|NCT00700310|EG000|Reported Event|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
10927668|NCT00700310|EG001|Reported Event|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
10927669|NCT00700310|EG002|Reported Event|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
10927670|NCT00700310|EG003|Reported Event|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
10927671|NCT00700336|BG000|Baseline|Pemetrexed, Cisplatin, and CBP501: Phase 2|"pemetrexed, cisplatin and CBP501~pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.~Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
10927672|NCT00700336|BG001|Baseline|Pemetrexed and Cisplatin: Phase 2|"pemetrexed and cisplatin~pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
10927673|NCT00700336|BG002|Baseline|Pemetrexed, Cisplatin, and CBP501: Phase 1|DL1: CBP501 16mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2
10927674|NCT00700336|BG003|Baseline|Total|Total of all reporting groups
11175605|NCT02030119|OG000|Outcome|Control|"The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
10927675|NCT00700336|FG000|Participant Flow|Pemetrexed, Cisplatin and CBP501: Phase 2|"pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.~Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
10927676|NCT00700336|FG001|Participant Flow|Pemetrexed and Cisplatin: Phase 2|"pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
10927677|NCT00700336|FG002|Participant Flow|Pemetrexed, Cisplatin and CBP501: Phase 1|DL1: CBP501 16mg/m2, pemetrexed 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, pemetrexed 500mg/m2, cisplatin 75mg/m2
10927678|NCT00700336|OG000|Outcome|Pemetrexed, Cisplatin, and CBP501|Pemetrexed, Cisplatin, and CBP501 administered once every 3 weeks
10927679|NCT00700336|OG001|Outcome|Pemetrexed and Cisplatin|Pemetrexed and Cisplatin every three weeks
10927680|NCT00700336|EG000|Reported Event|Pemetrexed, Cisplatin, and CBP501: Phase 2|"pemetrexed, cisplatin and CBP501~pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.~Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
10927681|NCT00700336|EG001|Reported Event|Pemetrexed and Cisplatin: Phase 2|"pemetrexed and cisplatin~pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
10927682|NCT00700336|EG002|Reported Event|Pemetrexed, Cisplatin, and CBP501: Phase 1|DL1: CBP501 16mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2
10927683|NCT00700375|BG000|Baseline|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
10927684|NCT00700375|BG001|Baseline|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
10927685|NCT00700375|BG002|Baseline|Total|Total of all reporting groups
10927686|NCT00700375|FG000|Participant Flow|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
10927687|NCT00700375|FG001|Participant Flow|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
10963253|NCT00871143|BG000|Baseline|CBT Specific for BDD|This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.
10927688|NCT00700375|OG000|Outcome|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
10927689|NCT00700375|OG001|Outcome|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
10927690|NCT00700375|EG000|Reported Event|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
10927691|NCT00700375|EG001|Reported Event|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
10927692|NCT00700401|BG000|Baseline|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
10927693|NCT00700401|FG000|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
10927694|NCT00700401|OG000|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
10927695|NCT00700401|EG000|Reported Event|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
10927696|NCT00700427|BG000|Baseline|Atomoxetine (40-100 mg)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment period (Study Period 2).
10927697|NCT00700427|FG000|Participant Flow|Atomoxetine (Study Period 2)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).
10927698|NCT00700427|FG001|Participant Flow|Atomoxetine (Study Period 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind randomized withdrawal phase (Study Period 3).
10927699|NCT00700427|FG002|Participant Flow|Atomoxetine (Study Period 3B)|80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
10927700|NCT00700427|FG003|Participant Flow|Placebo (Study Period 3B)|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
10927701|NCT00700427|FG004|Participant Flow|Atomoxetine (Study Period 4)|Participants who received either atomoxetine or placebo and completed the last visit of Study Period 3 who were in countries where the adult ADHD indication for atomoxetine was not approved were allowed to participant in Study Period 4 (Open-label Extension). Participants received 40 mg/day atomoxetine orally for at least 7 days after which it was increased to 80-100 mg/day atomoxetine orally for up to 2.3 years.
11175606|NCT02030119|OG001|Outcome|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
10927702|NCT00700427|OG000|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
10927703|NCT00700427|OG001|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
10927704|NCT00700427|EG000|Reported Event|Atomoxetine (Study Periods 2 and 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).
10927705|NCT00700427|EG001|Reported Event|Atomoxetine (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).~Followed by 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
11175607|NCT02030119|OG002|Outcome|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
11175608|NCT02030119|OG003|Outcome|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
11175609|NCT02030119|EG000|Reported Event|Control|"The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
10927706|NCT00700427|EG002|Reported Event|Placebo (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).~Followed by Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
10927707|NCT00700427|EG003|Reported Event|Atomoxetine (Study Period 4; Open-Label Extension)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A) and for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B), followed by a 2 year open label extension (Study Period 4). The open-label extension was optional and only offered to participants living in countries where atomoxetine for the adult ADHD indication had not been approved who had completed the Study Period 3B and were receiving benefit from the drug.
10927708|NCT00700440|BG000|Baseline|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
10927709|NCT00700440|FG000|Participant Flow|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
10927710|NCT00700440|OG000|Outcome|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
10927711|NCT00700440|EG000|Reported Event|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
10927712|NCT00700570|BG000|Baseline|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
10927713|NCT00700570|BG001|Baseline|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
10927714|NCT00700570|BG002|Baseline|Total|Total of all reporting groups
11175610|NCT02030119|EG001|Reported Event|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
11175611|NCT02030119|EG002|Reported Event|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
10927715|NCT00700570|FG000|Participant Flow|Resected|Participants with unresectable liver metastases secondary to colorectal cancer (CRC) were assigned to receive neoadjuvant treatment of intravenous (IV) bevacizumab with oral (PO) capecitabine and IV oxaliplatin (XELOX). Bevacizumab was given as 5 milligrams per kilogram (mg/kg) on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 milligrams per meter-squared (mg/m^2) on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
10927716|NCT00700570|FG001|Participant Flow|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, repeated neoadjuvant treatment until documented resectability or progressive disease (PD). Participants could be withdrawn at any point for unacceptable toxicity.
10927717|NCT00700570|OG000|Outcome|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
10927718|NCT00700570|OG000|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
10927719|NCT00700570|OG001|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
10927720|NCT00700570|EG000|Reported Event|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
10927721|NCT00700622|BG000|Baseline|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
10927722|NCT00700622|BG001|Baseline|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
10927723|NCT00700622|BG002|Baseline|Total|Total of all reporting groups
10927724|NCT00700622|FG000|Participant Flow|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
10927725|NCT00700622|FG001|Participant Flow|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
10927726|NCT00700622|OG000|Outcome|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
10927727|NCT00700622|OG001|Outcome|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
10927728|NCT00700622|EG000|Reported Event|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
10927729|NCT00700622|EG001|Reported Event|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
10927730|NCT00700635|BG000|Baseline|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
10927731|NCT00700635|BG001|Baseline|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
10927732|NCT00700635|BG002|Baseline|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
10927733|NCT00700635|BG003|Baseline|Total|Total of all reporting groups
10927734|NCT00700635|FG000|Participant Flow|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
10927735|NCT00700635|FG001|Participant Flow|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
10927736|NCT00700635|FG002|Participant Flow|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
10927737|NCT00700635|OG000|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
10927738|NCT00700635|OG001|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
10927739|NCT00700635|OG002|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
10927740|NCT00700635|EG000|Reported Event|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
11175612|NCT02030119|EG003|Reported Event|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
11175613|NCT02030288|BG000|Baseline|Relational Agent Plus Treatment As Usual|"Relational Agent Intervention plus Treatment as Usual~Relational Agent Intervention: Relational Agents are on-screen characters that speak to the patient and establish a relationship with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change."
11175614|NCT02030288|BG001|Baseline|Treatment as Usual|"Treatment as Usual~Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment."
11175615|NCT02030288|BG002|Baseline|Total|Total of all reporting groups
10927741|NCT00700635|EG001|Reported Event|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
10927742|NCT00700635|EG002|Reported Event|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
10927743|NCT00700713|BG000|Baseline|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
10927744|NCT00700713|BG001|Baseline|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26
10927745|NCT00700713|BG002|Baseline|Menactra-naïve Group|Participants had never received Menactra® vaccine.
10927746|NCT00700713|BG003|Baseline|Total|Total of all reporting groups
10927747|NCT00700713|FG000|Participant Flow|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
10927748|NCT00700713|FG001|Participant Flow|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
10927749|NCT00700713|FG002|Participant Flow|Menactra-naïve Group|Participants had never received Menactra® vaccine.
10927750|NCT00700713|OG000|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
10927751|NCT00700713|OG001|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
10927752|NCT00700713|OG002|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
11192075|NCT02136576|OG000|Outcome|Sensodyne|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study."
10927753|NCT00700713|EG000|Reported Event|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
10927754|NCT00700713|EG001|Reported Event|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
10927755|NCT00700713|EG002|Reported Event|Menactra-naïve Group|Participants had never received Menactra® vaccine.
10927756|NCT00700739|BG000|Baseline|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
10927757|NCT00700739|BG001|Baseline|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
10927758|NCT00700739|BG002|Baseline|Total|Total of all reporting groups
10927759|NCT00700739|FG000|Participant Flow|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
10927760|NCT00700739|FG001|Participant Flow|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
10927761|NCT00700739|OG000|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
10927762|NCT00700739|OG001|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
10927763|NCT00700739|OG000|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
10927764|NCT00700739|EG000|Reported Event|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
10927765|NCT00700739|EG001|Reported Event|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
10927766|NCT00700752|BG000|Baseline|Overall|Completed study population
10927767|NCT00700752|FG000|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
10927768|NCT00700752|FG001|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
10927769|NCT00700752|OG000|Outcome|Senofilcon A|silicone hydrogel contact lens worn daily with a 2-week replacement regimen.
10927770|NCT00700752|OG001|Outcome|Balafilcon A|silicone hydrogel contact lens worn daily with a 4-week replacement regimen
10927771|NCT00700752|EG000|Reported Event|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
10927772|NCT00700752|EG001|Reported Event|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
10927773|NCT00700804|BG000|Baseline|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
10927774|NCT00700804|BG001|Baseline|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
10927775|NCT00700804|BG002|Baseline|Total|Total of all reporting groups
10927776|NCT00700804|FG000|Participant Flow|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
10927777|NCT00700804|FG001|Participant Flow|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
10927778|NCT00700804|OG000|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
10927779|NCT00700804|OG001|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
10927780|NCT00700804|EG000|Reported Event|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
10927781|NCT00700804|EG001|Reported Event|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
10927782|NCT00700817|BG000|Baseline|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
10927783|NCT00700817|BG001|Baseline|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
10927784|NCT00700817|BG002|Baseline|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
10927785|NCT00700817|BG003|Baseline|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
10927786|NCT00700817|BG004|Baseline|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
10927787|NCT00700817|BG005|Baseline|Total|Total of all reporting groups
10927788|NCT00700817|FG000|Participant Flow|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
10927789|NCT00700817|FG001|Participant Flow|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
10927790|NCT00700817|FG002|Participant Flow|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
10927791|NCT00700817|FG003|Participant Flow|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
10927792|NCT00700817|FG004|Participant Flow|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
10927793|NCT00700817|OG000|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
10927794|NCT00700817|OG001|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
10927795|NCT00700817|OG002|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
10927796|NCT00700817|OG003|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
10927797|NCT00700817|OG004|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
10927798|NCT00700817|EG000|Reported Event|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
10927799|NCT00700817|EG001|Reported Event|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
10927800|NCT00700817|EG002|Reported Event|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
10927805|NCT00700973|BG000|Baseline|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
10927806|NCT00700973|BG001|Baseline|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
10927807|NCT00700973|BG002|Baseline|Total|Total of all reporting groups
10927808|NCT00700973|FG000|Participant Flow|Usual Care|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
10927809|NCT00700973|FG001|Participant Flow|IPV-P|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
10927810|NCT00700973|OG000|Outcome|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
10927811|NCT00700973|OG001|Outcome|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
10927812|NCT00700973|EG000|Reported Event|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
10927813|NCT00700973|EG001|Reported Event|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
10927814|NCT00700999|BG000|Baseline|Treatment Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
10927815|NCT00700999|BG001|Baseline|Combat Exposed Controls|veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
10927816|NCT00700999|BG002|Baseline|Total|Total of all reporting groups
10927817|NCT00700999|FG000|Participant Flow|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD. Completed 12 weeks of treatment with paroxetine (20-40mg QD)
10927818|NCT00700999|FG001|Participant Flow|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
10927819|NCT00700999|OG000|Outcome|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
10927820|NCT00700999|OG001|Outcome|Combat Exposed Control|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD.
10927821|NCT00700999|EG000|Reported Event|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
10927822|NCT00700999|EG001|Reported Event|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
10927823|NCT00701038|BG000|Baseline|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
10927824|NCT00701038|BG001|Baseline|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
10927825|NCT00701038|BG002|Baseline|Total|Total of all reporting groups
10927826|NCT00701038|FG000|Participant Flow|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
10927827|NCT00701038|FG001|Participant Flow|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
10927828|NCT00701038|OG000|Outcome|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
10927829|NCT00701038|OG001|Outcome|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
10927830|NCT00701038|EG000|Reported Event|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
10927831|NCT00701038|EG001|Reported Event|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
10927832|NCT00701051|BG000|Baseline|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
10927833|NCT00701051|BG001|Baseline|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
10927834|NCT00701051|BG002|Baseline|Total|Total of all reporting groups
10927835|NCT00701051|FG000|Participant Flow|Older Adults|
10927836|NCT00701051|FG001|Participant Flow|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance. Participants assigned to group after Period 1: Screening
10927837|NCT00701051|FG002|Participant Flow|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance. Participants assigned to group after Period 1: Screening
10927838|NCT00701051|OG000|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
10927839|NCT00701051|OG001|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
10927840|NCT00701051|OG000|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
10927841|NCT00701051|EG000|Reported Event|Older Adults|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm); thus, data are reported for the entire group of participants.
10927842|NCT00701064|BG000|Baseline|Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
10927843|NCT00701064|BG001|Baseline|Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
10927844|NCT00701064|BG002|Baseline|Total|Total of all reporting groups
10927845|NCT00701064|FG000|Participant Flow|Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
10927846|NCT00701064|FG001|Participant Flow|Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
10927847|NCT00701064|OG000|Outcome|Arm 1: Bright Light|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
10927848|NCT00701064|OG001|Outcome|Arm 2: Placebo Negative Ion Generator|"Negative Ion Generator (30 min/day)~Inactivated Negative Ion Generator: Administered via Negative Ion Generator"
10927849|NCT00701064|EG000|Reported Event|Arm 1: Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
10927850|NCT00701064|EG001|Reported Event|Arm 2: Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
10927851|NCT00701090|BG000|Baseline|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
10927852|NCT00701090|BG001|Baseline|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
10927853|NCT00701090|BG002|Baseline|Total|Total of all reporting groups
10927854|NCT00701090|FG000|Participant Flow|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
11175616|NCT02030288|FG000|Participant Flow|Relational Agent|"Relational Agent Intervention~Relational Agent Intervention: Relational Agents are on-screen characters that speak to the patient and establish a relationship with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change."
11175617|NCT02030288|FG001|Participant Flow|Treatment as Usual|Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.
10927855|NCT00701090|FG001|Participant Flow|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
10927856|NCT00701090|OG000|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
10927857|NCT00701090|OG001|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
10927858|NCT00701090|EG000|Reported Event|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
10927859|NCT00701090|EG001|Reported Event|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
10927860|NCT00701103|BG000|Baseline|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
10927861|NCT00701103|BG001|Baseline|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
10927862|NCT00701103|BG002|Baseline|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
10927863|NCT00701103|BG003|Baseline|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
10927864|NCT00701103|BG004|Baseline|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
10927865|NCT00701103|BG005|Baseline|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
10927866|NCT00701103|BG006|Baseline|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
10927867|NCT00701103|BG007|Baseline|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
10927868|NCT00701103|BG008|Baseline|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
10927869|NCT00701103|BG009|Baseline|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
10927870|NCT00701103|BG010|Baseline|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
10927871|NCT00701103|BG011|Baseline|Total|Total of all reporting groups
10927872|NCT00701103|FG000|Participant Flow|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
10927873|NCT00701103|FG001|Participant Flow|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
10927874|NCT00701103|FG002|Participant Flow|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
10927875|NCT00701103|FG003|Participant Flow|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
10927876|NCT00701103|FG004|Participant Flow|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
10927877|NCT00701103|FG005|Participant Flow|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
10927878|NCT00701103|FG006|Participant Flow|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
10927879|NCT00701103|FG007|Participant Flow|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
10927880|NCT00701103|FG008|Participant Flow|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
10927881|NCT00701103|FG009|Participant Flow|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
10927882|NCT00701103|FG010|Participant Flow|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
10927883|NCT00701103|OG000|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
10927884|NCT00701103|OG001|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
10927885|NCT00701103|OG002|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
10927886|NCT00701103|OG003|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
11175618|NCT02030288|OG000|Outcome|Relational Agent Plus Treatment as Usual|"Relational Agent Intervention~Relational Agent Intervention: Relational Agents are on-screen characters that speak to the patient and establish a relationship with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change."
11175619|NCT02030288|OG001|Outcome|Treatment as Usual|"Treatment as Usual~Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment."
11175620|NCT02030288|OG001|Outcome|Treatment as Usual (TAU)|In this primary care setting, Treatment as Usual follows an annual screening for unhealthy alcohol use. If the participant screens positive for unhealthy alcohol use, the primary care provider is required to provide a brief intervention (i.e., brief counseling) based on a a guided interview and checklist of items to discuss. The provider also should refer participants to specialty care based on the severity of their alcohol use.
11175621|NCT02030288|OG000|Outcome|Relational Agent|"Relational Agent Intervention~Relational Agent Intervention: Relational Agents are on-screen characters that speak to the patient and establish a relationship with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change."
11175622|NCT02030288|OG001|Outcome|Treatment as Usual|Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.
10927887|NCT00701103|OG004|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
10927888|NCT00701103|OG005|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
10927889|NCT00701103|OG006|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
10927890|NCT00701103|OG007|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
10927891|NCT00701103|OG008|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
10927892|NCT00701103|OG009|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
10927893|NCT00701103|OG010|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
10927894|NCT00701103|OG003|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
10927895|NCT00701103|OG004|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
10927896|NCT00701103|OG005|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
10927897|NCT00701103|OG006|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
10927898|NCT00701103|EG000|Reported Event|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
10927899|NCT00701103|EG001|Reported Event|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
10927900|NCT00701103|EG002|Reported Event|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
10927901|NCT00701103|EG003|Reported Event|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
10927902|NCT00701103|EG004|Reported Event|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
10927903|NCT00701103|EG005|Reported Event|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
10927904|NCT00701103|EG006|Reported Event|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.
10927905|NCT00701103|EG007|Reported Event|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
10927906|NCT00701103|EG008|Reported Event|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.
10927907|NCT00701103|EG009|Reported Event|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
10927908|NCT00701103|EG010|Reported Event|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
10927909|NCT00701129|BG000|Baseline|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
10927910|NCT00701129|FG000|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 milligrams per kilogram (mg/kg) intravenous (IV) infusion every other week (qow) (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was less than (<) 6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 milligrams per square meter (mg/m^2) (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
10927911|NCT00701129|OG000|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
10927912|NCT00701129|EG000|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
10927913|NCT00701311|BG000|Baseline|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
10927914|NCT00701311|FG000|Participant Flow|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
10927915|NCT00701311|OG000|Outcome|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
10927916|NCT00701311|EG000|Reported Event|Treatment Arm|Open label, one arm study.
10927917|NCT00701363|BG000|Baseline|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
10927918|NCT00701363|BG001|Baseline|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
10927919|NCT00701363|BG002|Baseline|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
10927920|NCT00701363|BG003|Baseline|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
10927921|NCT00701363|BG004|Baseline|Total|Total of all reporting groups
10927922|NCT00701363|FG000|Participant Flow|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
10927923|NCT00701363|FG001|Participant Flow|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
10927924|NCT00701363|FG002|Participant Flow|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
10927925|NCT00701363|FG003|Participant Flow|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
10927926|NCT00701363|OG000|Outcome|Overall Study|
10927927|NCT00701363|OG000|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
10927928|NCT00701363|OG001|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
10927929|NCT00701363|OG002|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
10927930|NCT00701363|OG000|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|Only 15 subjects participated only in phase 1 and did not move on to phase 2. The other entered in phase 2 according to IGF-1 level. Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
10927931|NCT00701363|OG001|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
10927932|NCT00701363|OG002|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
10927933|NCT00701363|OG003|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
10927934|NCT00701363|OG000|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
10927935|NCT00701363|OG001|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
10927936|NCT00701363|OG002|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
10927937|NCT00701363|OG003|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
10927938|NCT00701363|OG004|Outcome|Overall Study|
10927939|NCT00701363|OG000|Outcome|Overall Study|Lanreotide Autogel 120 mg injections every 6 weeks, then depending on IGF-1 results at Week 24
10927940|NCT00701363|EG000|Reported Event|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
10927941|NCT00701363|EG001|Reported Event|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
10927942|NCT00701363|EG002|Reported Event|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
10927943|NCT00701363|EG003|Reported Event|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
10927944|NCT00701376|BG000|Baseline|Roux-en-Y Gastric Bypass (RYGB)|Before the treatment of RYGB surgery, eligible patients had preoperative liver function assessment including biochemical testing: AST, ALT, ALK, total bilirubin, albumin, and prothrombin (PT). During RYGB, a core liver biopsy was conducted. Serum lipid profiles and HbA1c values were medially optimized. Patients were asked to refrain from alcohol use for several preoperative days and discontinue hepatotoxic medications. Once patients lost 60% of their preoperative excess weight or weight loss had plateaued after RYGB surgery, they were reassessed on liver function(same as preoperative) and histology. Patients who had stable weight loss and were found to have clinically important liver damage as determined by liver biopsy at the time of RYGB were offered with repeat percutaneous ultrasound-guided liver biopsies after RYGB.
10927945|NCT00701376|FG000|Participant Flow|Roux-en-Y Gastric Bypass (RYGB)|Before the treatment of RYGB surgery, eligible patients had preoperative liver function assessment including biochemical testing: AST, ALT, ALK, total bilirubin, albumin, and prothrombin (PT). During RYGB, a core liver biopsy was conducted. Serum lipid profiles and HbA1c values were medially optimized. Patients were asked to refrain from alcohol use for several preoperative days and discontinue hepatotoxic medications. Once patients lost 60% of their preoperative excess weight or weight loss had plateaued after RYGB surgery, they were reassessed on liver function(same as preoperative) and histology. Patients who had stable weight loss and were found to have clinically important liver damage as determined by liver biopsy at the time of RYGB were offered with repeat percutaneous ultrasound-guided liver biopsies after RYGB.
10927946|NCT00701376|OG000|Outcome|Roux-en-Y Gastric Bypass (RYGB)|Before the treatment of RYGB surgery, eligible patients had preoperative liver function assessment including biochemical testing: AST, ALT, ALK, total bilirubin, albumin, and prothrombin (PT). During RYGB, a core liver biopsy was conducted. Serum lipid profiles and HbA1c values were medially optimized. Patients were asked to refrain from alcohol use for several preoperative days and discontinue hepatotoxic medications.
10927947|NCT00701376|OG000|Outcome|Roux-en-Y Gastric Bypass (RYGB)|Before the treatment of RYGB surgery, eligible patients had preoperative liver function assessment including biochemical testing: AST, ALT, ALK, total bilirubin, albumin, and prothrombin (PT). During RYGB, a core liver biopsy was conducted. Serum lipid profiles and HbA1c values were medially optimized. Patients were asked to refrain from alcohol use for several preoperative days and discontinue hepatotoxic medications. Once patients lost 60% of their preoperative excess weight or weight loss had plateaued after RYGB surgery, they were reassessed on liver function(same as preoperative) and histology. Patients who had stable weight loss and were found to have clinically important liver damage as determined by liver biopsy at the time of RYGB were offered with repeat percutaneous ultrasound-guided liver biopsies after RYGB.
10927948|NCT00701376|EG000|Reported Event|Liver Function|"Subjects undergoing laparoscopic gastric surgery will be evaluated for liver function by comparing liver tissue biopsied during surgery with tissue biopsied after 60% weight loss~liver biopsy: Subjects undergoing laparoscopic gastric surgery will be evaluated for liver function by comparing liver tissue biopsied during surgery with tissue biopsied after 60% weight loss"
10927949|NCT00701389|BG000|Baseline|All Enrolled Participants|All participants enrolled in the study
10927950|NCT00701389|FG000|Participant Flow|Sequence 1: A→C→D→B|Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout.
10927951|NCT00701389|FG001|Participant Flow|Sequence 2: B→D→C→A|Participants receive the following: Period 1:single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout.
10927952|NCT00701389|FG002|Participant Flow|Sequence 3: C→B→A→D|Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout.
11175623|NCT02030288|OG000|Outcome|Relational Agent Plus Treatment as Usual|"Relational Agent Intervention: Relational Agents are on-screen characters that speak to the patient and establish a relationship with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change."
11175624|NCT02030288|EG000|Reported Event|Relational Agent|"Relational Agent Intervention~Relational Agent Intervention: Relational Agents are on-screen characters that speak to the patient and establish a relationship with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change."
11175625|NCT02030288|EG001|Reported Event|Treatment as Usual|"Treatment as Usual~Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment."
11175626|NCT02030405|BG000|Baseline|Ixazomib (MLN9708)|Participants receive ixazomib (orally) PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10927953|NCT00701389|FG003|Participant Flow|Sequence 4: D→A→B→C|Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.
10927954|NCT00701389|OG000|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
10927955|NCT00701389|OG001|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
10927956|NCT00701389|OG000|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
10927957|NCT00701389|OG001|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
10927958|NCT00701389|OG002|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
10927959|NCT00701389|OG003|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
10927960|NCT00701389|OG002|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of generic placebo/600 mg telcagepant in either Period 1, 2, 3, or 4 in the crossover
11175627|NCT02030405|FG000|Participant Flow|Ixazomib (MLN9708)|Participants receive ixazomib (orally) PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11175628|NCT02030405|OG000|Outcome|Ixazomib (MLN9708)|Participants receive ixazomib (orally) PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11175629|NCT02030405|OG000|Outcome|Ixazomib (MLN9708)|"Participants receive ixazomib PO (orally) on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Ixazomib: Given orally (PO)"
11175630|NCT02030405|EG000|Reported Event|Ixazomib (MLN9708)|Participants receive ixazomib (orally) PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11175631|NCT02030535|BG000|Baseline|Overall Study|Total number of patients randomised and treated in the study.
10927961|NCT00701389|OG003|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of generic placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
10927962|NCT00701389|EG000|Reported Event|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
10927963|NCT00701389|EG001|Reported Event|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
10927964|NCT00701389|EG002|Reported Event|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
10927965|NCT00701389|EG003|Reported Event|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
10927966|NCT00701415|BG000|Baseline|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
10927967|NCT00701415|BG001|Baseline|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
10927968|NCT00701415|BG002|Baseline|Total|Total of all reporting groups
10927969|NCT00701415|FG000|Participant Flow|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
10927970|NCT00701415|FG001|Participant Flow|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
10927971|NCT00701415|OG000|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
10927972|NCT00701415|OG001|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
10927973|NCT00701415|EG000|Reported Event|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
10927974|NCT00701415|EG001|Reported Event|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
10927975|NCT00701441|BG000|Baseline|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
10927976|NCT00701441|BG001|Baseline|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
10927977|NCT00701441|BG002|Baseline|Total|Total of all reporting groups
10927978|NCT00701441|FG000|Participant Flow|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
10927979|NCT00701441|FG001|Participant Flow|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
10927980|NCT00701441|OG000|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment
10927981|NCT00701441|OG001|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure
10927982|NCT00701441|OG002|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(% dilation change from baseline)
10927983|NCT00701441|OG000|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment(Stain Density Units)
10927984|NCT00701441|OG001|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure(Stain Density Units)
10927985|NCT00701441|OG002|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(Stain Density Units)
10927986|NCT00701441|EG000|Reported Event|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
10927987|NCT00701441|EG001|Reported Event|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
10927988|NCT00701558|BG000|Baseline|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
10927989|NCT00701558|FG000|Participant Flow|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
10927990|NCT00701558|OG000|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
10927991|NCT00701558|EG000|Reported Event|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
10927992|NCT00701636|BG000|Baseline|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
10927993|NCT00701636|BG001|Baseline|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
10927994|NCT00701636|BG002|Baseline|Total|Total of all reporting groups
10927995|NCT00701636|FG000|Participant Flow|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
10927996|NCT00701636|FG001|Participant Flow|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
11175632|NCT02030535|FG000|Participant Flow|Overall Study|Total number of patients randomised and treated in the study. (This is a cross-over trial consisting of a minimum two-week screening period. After screening, eligible patients were randomly assigned to one of 12 treatment sequences. Each patient received all three treatments as single doses on the three test days. Between test days with single dose administration there are 3-week washout periods.)
11175633|NCT02030535|OG000|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
11175634|NCT02030535|OG001|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
11175635|NCT02030535|OG002|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
11175636|NCT02030535|OG001|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
11175637|NCT02030535|OG002|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
10927997|NCT00701636|OG000|Outcome|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis for CABG.
10927998|NCT00701636|EG000|Reported Event|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
10927999|NCT00701636|EG001|Reported Event|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
10928000|NCT00701662|BG000|Baseline|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
10928001|NCT00701662|FG000|Participant Flow|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
10928002|NCT00701662|OG000|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
10928003|NCT00701662|EG000|Reported Event|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
10928004|NCT00701675|BG000|Baseline|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
10928005|NCT00701675|BG001|Baseline|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
10928006|NCT00701675|BG002|Baseline|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
10928007|NCT00701675|BG003|Baseline|Total|Total of all reporting groups
10928008|NCT00701675|FG000|Participant Flow|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
10928009|NCT00701675|FG001|Participant Flow|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
10928010|NCT00701675|FG002|Participant Flow|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
10928011|NCT00701675|OG000|Outcome|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
10928012|NCT00701675|OG001|Outcome|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
10928013|NCT00701675|OG002|Outcome|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
10928014|NCT00701675|EG000|Reported Event|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
10928015|NCT00701675|EG001|Reported Event|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
10928016|NCT00701675|EG002|Reported Event|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
11175638|NCT02030535|OG000|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations ante meridiem (a.m.) dosing."
11175639|NCT02030535|OG001|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler."
11175640|NCT02030535|OG002|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler."
10928017|NCT00701701|BG000|Baseline|Regimen A: Alglucosidase Alfa and Cyclophosphamide|Participants exhibiting clinical decline since starting alglucosidase alfa (Myozyme®) therapy and having inhibitory antibodies and/or a sustained high rhGAA antibody titer (defined as at least 2 titers >=25,600 obtained at least 1 month apart), regardless of their CRIM status, were assigned to Regimen A. In Regimen A, participants received alglucosidase alfa (Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or, until the participant reached the age of 2 years (if the participant was <6 months of age at the time of enrollment). In addition, cyclophosphamide 250 mg/m^2 IV infusion was administered q4w after Myozyme® infusion for 6 months.
10928018|NCT00701701|BG001|Baseline|Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate|CRIM-negative participants were assigned to Regimen B if they either(1)exhibited clinical decline since starting alglucosidase alfa (Myozyme®)therapy and did not have inhibitory antibodies and/or a sustained rhGAA antibody titer(defined as at least 2 titers >=25,600 obtained at least 1 month apart),or(2) did not exhibit clinical decline since starting alglucosidase alfa(Myozyme®) therapy, regardless of their anti-rhGAA or inhibitory antibody status. Regimen B participants with CRIM-negative status received alglucosidase alfa(Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or,until participant reached the age of 2 years (if participant was <6 months of age at time of enrollment). In addition,rituximab 375 mg/m^2 IV was administered weekly beginning the day after Myozyme® infusion for 4 weeks(an optional 2nd cycle could be administered at the discretion of the investigator) and biweekly methotrexate 15 mg/m^2 subcutaneous on the day after Myozyme® infusion for 6 months.
10928019|NCT00701701|BG002|Baseline|Total|Total of all reporting groups
10928020|NCT00701701|FG000|Participant Flow|Regimen A: Alglucosidase Alfa and Cyclophosphamide|Participants exhibiting clinical decline since starting alglucosidase alfa (Myozyme®) therapy and having inhibitory antibodies and/or a sustained high recombinant human acid alpha-glucosidase (rhGAA) antibody titer (defined as at least 2 titers greater than or equal to [>=] 25,600 obtained at least 1 month apart), regardless of their cross-reacting immunologic material (CRIM) status, were assigned to Regimen A. In Regimen A, participants received alglucosidase alfa (Myozyme®) Intravenous (IV) infusion of 20 milligram per kilogram (mg/kg) every other week (qow) for a minimum of 18 months or, until the participant reached the age of 2 years (if the participant was less than [<6] months of age at the time of enrollment). In addition, cyclophosphamide 250 milligram per square meter (mg/m^2) IV infusion was administered every 4 weeks (q4w) after Myozyme® infusion for 6 months.
10928021|NCT00701701|FG001|Participant Flow|Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate|CRIM-negative participants were assigned to Regimen B if they either(1)exhibited clinical decline since starting alglucosidase alfa (Myozyme®)therapy and did not have inhibitory antibodies and/or a sustained rhGAA antibody titer(defined as at least 2 titers >=25,600 obtained at least 1 month apart),or(2) did not exhibit clinical decline since starting alglucosidase alfa(Myozyme®) therapy, regardless of their anti-rhGAA or inhibitory antibody status. Regimen B participants with CRIM-negative status received alglucosidase alfa(Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or,until participant reached the age of 2 years (if participant was <6 months of age at time of enrollment). In addition,rituximab 375 mg/m^2 IV was administered weekly beginning the day after Myozyme® infusion for 4 weeks(an optional 2nd cycle could be administered at the discretion of the investigator) and biweekly methotrexate 15 mg/m^2 subcutaneous on the day after Myozyme® infusion for 6 months.
10928022|NCT00701701|OG000|Outcome|Regimen A: Alglucosidase Alfa and Cyclophosphamide|Participants exhibiting clinical decline since starting alglucosidase alfa (Myozyme®) therapy and having inhibitory antibodies and/or a sustained high rhGAA antibody titer (defined as at least 2 titers >=25,600 obtained at least 1 month apart), regardless of their CRIM status, were assigned to Regimen A. In Regimen A, participants received alglucosidase alfa (Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or, until the participant reached the age of 2 years (if the participant was <6 months of age at the time of enrollment). In addition, cyclophosphamide 250 mg/m^2 IV infusion was administered q4w after Myozyme® infusion for 6 months.
10928023|NCT00701701|OG001|Outcome|Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate|CRIM-negative participants were assigned to Regimen B if they either(1)exhibited clinical decline since starting alglucosidase alfa (Myozyme®)therapy and did not have inhibitory antibodies and/or a sustained rhGAA antibody titer(defined as at least 2 titers >=25,600 obtained at least 1 month apart),or(2) did not exhibit clinical decline since starting alglucosidase alfa(Myozyme®) therapy, regardless of their anti-rhGAA or inhibitory antibody status. Regimen B participants with CRIM-negative status received alglucosidase alfa(Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or,until participant reached the age of 2 years (if participant was <6 months of age at time of enrollment). In addition,rituximab 375 mg/m^2 IV was administered weekly beginning the day after Myozyme® infusion for 4 weeks(an optional 2nd cycle could be administered at the discretion of the investigator) and biweekly methotrexate 15 mg/m^2 subcutaneous on the day after Myozyme® infusion for 6 months.
10928024|NCT00701701|OG000|Outcome|Regimen A: Alglucosidase Alfa and Cyclophosphamide|Participants exhibiting clinical decline since starting alglucosidase alfa (Myozyme®) therapy and having inhibitory antibodies and/or a sustained high rhGAA antibody titer (defined as at least 2 titers >= 25,600 obtained at least 1 month apart), regardless of their CRIM status, were assigned to Regimen A. In Regimen A, participants received alglucosidase alfa (Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or, until the participant reached the age of 2 years (if the participant was <6 months of age at the time of enrollment). In addition, cyclophosphamide 250 mg/m^2 IV infusion was administered q4w after Myozyme® infusion for 6 months.
11175641|NCT02030535|OG002|Outcome|Tiotropium 5μg + Olodaterol 5μg|Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination) Olodaterol: 5 μg (2.5 μg per actuation) Tiotropium: 5 μg (2.5 μg per actuation) 2 inhalations a.m. dosing via RESPIMAT® inhaler
11175642|NCT02030535|EG000|Reported Event|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
11175643|NCT02030535|EG001|Reported Event|Tio+Olo FDC|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation via RESPIMAT inhaler.~2 inhalations a.m. dosing."
10928025|NCT00701701|EG000|Reported Event|Regimen A: Alglucosidase Alfa and Cyclophosphamide|Participants exhibiting clinical decline since starting alglucosidase alfa (Myozyme®) therapy and having inhibitory antibodies and/or a sustained high rhGAA antibody titer (defined as at least 2 titers >=25,600 obtained at least 1 month apart), regardless of their CRIM status, were assigned to Regimen A. In Regimen A, participants received alglucosidase alfa (Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or, until the participant reached the age of 2 years (if the participant was <6 months of age at the time of enrollment). In addition, cyclophosphamide 250 mg/m^2 IV infusion was administered q4w after Myozyme® infusion for 6 months.
10928026|NCT00701701|EG001|Reported Event|Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate|CRIM-negative participants were assigned to Regimen B if they either(1)exhibited clinical decline since starting alglucosidase alfa (Myozyme®)therapy and did not have inhibitory antibodies and/or a sustained rhGAA antibody titer(defined as at least 2 titers >=25,600 obtained at least 1 month apart),or(2) did not exhibit clinical decline since starting alglucosidase alfa(Myozyme®) therapy, regardless of their anti-rhGAA or inhibitory antibody status. Regimen B participants with CRIM-negative status received alglucosidase alfa(Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or,until participant reached the age of 2 years (if participant was <6 months of age at time of enrollment). In addition,rituximab 375 mg/m^2 IV was administered weekly beginning the day after Myozyme® infusion for 4 weeks(an optional 2nd cycle could be administered at the discretion of the investigator) and biweekly methotrexate 15 mg/m^2 subcutaneous on the day after Myozyme® infusion for 6 months.
10928027|NCT00701714|BG000|Baseline|Treatmen HX575 EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
10928028|NCT00701714|BG001|Baseline|Treatment ERYPO|ERYPO: Solution for injection (s.c.)
10928029|NCT00701714|BG002|Baseline|Total|Total of all reporting groups
10928030|NCT00701714|FG000|Participant Flow|HX575, EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
10928031|NCT00701714|FG001|Participant Flow|ERYPO|ERYPO: Solution for injection (s.c.)
10928032|NCT00701714|OG000|Outcome|HX575, EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
10928033|NCT00701714|OG001|Outcome|ERYPO|ERYPO: Solution for injection (s.c.)
10928034|NCT00701714|OG000|Outcome|Treatmen HX575 EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
10928035|NCT00701714|OG001|Outcome|Treatment ERYPO|ERYPO: Solution for injection (s.c.)
10928036|NCT00701714|EG000|Reported Event|Treatment HX575, EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
10928037|NCT00701714|EG001|Reported Event|Treatment ERYPO|ERYPO: Solution for injection (s.c.)
10928038|NCT00701714|EG002|Reported Event|Safety Follow-up HX575, EPO HEXAL|Patients received HX575, EPO HEXAL during Treatment Period
10928039|NCT00701714|EG003|Reported Event|Safety Follow-up ERYPO|Patients received ERYPO during Treatment Period
10928040|NCT00701727|BG000|Baseline|Entire Study Population|Includes groups randomized to receive ezetimibe first and placebo first
10928041|NCT00701727|FG000|Participant Flow|Ezetimibe First, Placebo Second|Ezetimibe first for 7 weeks, followed by placebo for 7 weeks
10928042|NCT00701727|FG001|Participant Flow|Placebo First, Ezetimibe Second|Placebo first for 7 weeks,followed by ezetimibe for 7 weeks
10928043|NCT00701727|OG000|Outcome|Placebo|placebo daily,7 weeks
10928044|NCT00701727|OG001|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
10928045|NCT00701727|EG000|Reported Event|Placebo|Placebo, 10 mg/day, for 7 weeks
10928046|NCT00701727|EG001|Reported Event|Ezetimibe|ezetimibe, 10 mg/day, for 7 weeks
10928047|NCT00701779|BG000|Baseline|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
10928048|NCT00701779|FG000|Participant Flow|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
10928049|NCT00701779|OG000|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
10928050|NCT00701779|EG000|Reported Event|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
10928051|NCT00701805|BG000|Baseline|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928052|NCT00701805|BG001|Baseline|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928053|NCT00701805|BG002|Baseline|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928054|NCT00701805|BG003|Baseline|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928055|NCT00701805|BG004|Baseline|Total|Total of all reporting groups
10928056|NCT00701805|FG000|Participant Flow|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928057|NCT00701805|FG001|Participant Flow|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928058|NCT00701805|FG002|Participant Flow|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928059|NCT00701805|FG003|Participant Flow|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928060|NCT00701805|OG000|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928061|NCT00701805|OG001|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928062|NCT00701805|OG002|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928063|NCT00701805|OG003|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
11175644|NCT02030535|EG002|Reported Event|Tiotropium and Olodaterol FC|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination FC (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing."
11175645|NCT02030574|BG000|Baseline|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
10928064|NCT00701805|EG000|Reported Event|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928065|NCT00701805|EG001|Reported Event|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928066|NCT00701805|EG002|Reported Event|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928067|NCT00701805|EG003|Reported Event|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
10928068|NCT00701896|BG000|Baseline|Nicotine Replacement Plus Motivational Interviewing|"PLWH who smoke~12 week intervention with telephone counseling plus:~Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)"
10928069|NCT00701896|BG001|Baseline|Varenicline Plus Motivational Interviewing|"PLWH who smoke~12 week intervention with telephone counseling plus:~Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily"
10928070|NCT00701896|BG002|Baseline|Total|Total of all reporting groups
10928071|NCT00701896|FG000|Participant Flow|Nicotine Replacement Plus Motivational Interviewing|"PLWH who smoke~12 week intervention with telephone counseling plus:~Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)"
10928072|NCT00701896|FG001|Participant Flow|Varenicline Plus Motivational Interviewing|"PLWH who smoke~12 week intervention with telephone counseling plus:~Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily"
10928073|NCT00701896|OG000|Outcome|Nicotine Replacement Plus Motivational Interviewing|"PLWH who smoke~12 week intervention with telephone counseling plus:~Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)"
10928074|NCT00701896|OG001|Outcome|Varenicline Plus Motivational Interviewing|"PLWH who smoke~12 week intervention with telephone counseling plus:~Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily"
10928075|NCT00701896|EG000|Reported Event|Nicotine Replacement Plus Motivational Interviewing|"PLWH who smoke~12 week intervention with telephone counseling plus:~Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)"
10928076|NCT00701896|EG001|Reported Event|Varenicline Plus Motivational Interviewing|"PLWH who smoke~12 week intervention with telephone counseling plus:~Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily"
10928077|NCT00701935|BG000|Baseline|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
10928078|NCT00701935|BG001|Baseline|Placebo|Subcutaneous injection of placebo twice a day for 6 months
10928079|NCT00701935|BG002|Baseline|Total|Total of all reporting groups
10928080|NCT00701935|FG000|Participant Flow|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
10928081|NCT00701935|FG001|Participant Flow|Placebo|Subcutaneous injection of placebo twice a day for 6 months
10928082|NCT00701935|OG000|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
10928083|NCT00701935|OG001|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
10928084|NCT00701935|EG000|Reported Event|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
10928085|NCT00701935|EG001|Reported Event|Placebo|Subcutaneous injection of placebo twice a day for 6 months
10928086|NCT00702052|BG000|Baseline|Everolimus|Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
10928087|NCT00702052|FG000|Participant Flow|Everolimus|Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
10928088|NCT00702052|OG000|Outcome|Everolimus|Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
10928089|NCT00702052|EG000|Reported Event|Everolimus|Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
10928090|NCT00702143|BG000|Baseline|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
10928091|NCT00702143|BG001|Baseline|MCI Subjects|MCI (mild cognitive impairment)
10928092|NCT00702143|BG002|Baseline|Healthy Controls|cognitively normal (healthy) controls
10928093|NCT00702143|BG003|Baseline|Total|Total of all reporting groups
10928094|NCT00702143|FG000|Participant Flow|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
10928095|NCT00702143|FG001|Participant Flow|MCI Subjects|MCI (mild cognitive impairment)
10928096|NCT00702143|FG002|Participant Flow|Healthy Controls|cognitively normal (healthy) controls
10928097|NCT00702143|OG000|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
10928098|NCT00702143|OG001|Outcome|MCI Subjects|MCI (mild cognitive impairment)
10928099|NCT00702143|OG002|Outcome|Healthy Controls|cognitively normal (healthy) controls
10928100|NCT00702143|EG000|Reported Event|All Subjects|All subjects receiving florbetapir F 18 injection
10928101|NCT00702208|BG000|Baseline|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
10928102|NCT00702208|FG000|Participant Flow|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)~All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
10928103|NCT00702208|OG000|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
10928104|NCT00702208|OG000|Outcome|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)~All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
10928105|NCT00702208|EG000|Reported Event|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
10928106|NCT00702221|BG000|Baseline|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
10928107|NCT00702221|BG001|Baseline|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
10928108|NCT00702221|BG002|Baseline|Total|Total of all reporting groups
10928109|NCT00702221|FG000|Participant Flow|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
10928110|NCT00702221|FG001|Participant Flow|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
10928111|NCT00702221|OG000|Outcome|Angiotensin Therapeutic Vaccine + CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
10928112|NCT00702221|OG001|Outcome|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
10928113|NCT00702221|EG000|Reported Event|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
10928114|NCT00702221|EG001|Reported Event|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
10928115|NCT00702299|BG000|Baseline|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
10928116|NCT00702299|FG000|Participant Flow|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
10928117|NCT00702299|OG000|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
10928118|NCT00702299|OG000|Outcome|Pemetrexed Dose 500mg/m2|Level 3 Pemetrexed dose 500mg/m2
10928119|NCT00702299|OG001|Outcome|Pemetrexed Dose 750 mg/m2|Level 4 Pemetrexed dose 750 mg/m2
10928120|NCT00702299|OG002|Outcome|Pemetrexed Dose 1,000mg/m2|Level 5 Pemetrexed dose 1,000mg/m2
10928121|NCT00702299|EG000|Reported Event|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
10928122|NCT00702325|BG000|Baseline|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
10928123|NCT00702325|BG001|Baseline|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
10928124|NCT00702325|BG002|Baseline|Total|Total of all reporting groups
10928125|NCT00702325|FG000|Participant Flow|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
10928126|NCT00702325|FG001|Participant Flow|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
10928127|NCT00702325|OG000|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
10928128|NCT00702325|OG001|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
10928129|NCT00702325|EG000|Reported Event|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
10928130|NCT00702325|EG001|Reported Event|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
10928131|NCT00702364|BG000|Baseline|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
10928132|NCT00702364|BG001|Baseline|Placebo|"Placebo twice a day for two weeks~placebo :"
10928133|NCT00702364|BG002|Baseline|Total|Total of all reporting groups
10928134|NCT00702364|FG000|Participant Flow|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
10928135|NCT00702364|FG001|Participant Flow|Placebo|"Placebo twice a day for two weeks~placebo :"
10928136|NCT00702364|OG000|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
10928137|NCT00702364|OG001|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
10928138|NCT00702364|EG000|Reported Event|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
10928139|NCT00702364|EG001|Reported Event|Placebo|"Placebo twice a day for two weeks~placebo :"
10928140|NCT00702377|BG000|Baseline|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
10928141|NCT00702377|BG001|Baseline|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
10928142|NCT00702377|BG002|Baseline|Total|Total of all reporting groups
10928143|NCT00702377|FG000|Participant Flow|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
10928144|NCT00702377|FG001|Participant Flow|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
10928145|NCT00702377|OG000|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
10928146|NCT00702377|OG001|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
10928147|NCT00702377|EG000|Reported Event|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
10928148|NCT00702377|EG001|Reported Event|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
10928149|NCT00702403|BG000|Baseline|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
10928150|NCT00702403|FG000|Participant Flow|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
10928151|NCT00702403|OG000|Outcome|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
10928152|NCT00702403|OG000|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
10928153|NCT00702403|OG000|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|"Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.~nilotinib: Given PO~imatinib mesylate: Given PO~pharmacological study: Correlative studies"
10928154|NCT00702403|OG000|Outcome|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood counts recover (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood counts recover until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
10928155|NCT00702403|EG000|Reported Event|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
10928156|NCT00702468|BG000|Baseline|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
10928157|NCT00702468|BG001|Baseline|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
10928158|NCT00702468|BG002|Baseline|Total|Total of all reporting groups
10928159|NCT00702468|FG000|Participant Flow|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
10928160|NCT00702468|FG001|Participant Flow|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
10928161|NCT00702468|OG000|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
10928162|NCT00702468|OG001|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
10928163|NCT00702468|EG000|Reported Event|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
10928164|NCT00702468|EG001|Reported Event|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
10928165|NCT00702507|BG000|Baseline|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
10928166|NCT00702507|FG000|Participant Flow|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
10928167|NCT00702507|OG000|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
10928168|NCT00702507|EG000|Reported Event|Vusion Initial Treatment Phase|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14.
10928169|NCT00702507|EG001|Reported Event|Vusion Follow-up Phase|After the Initial Treatment Phase participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment containing 0.25 percent miconazole nitrate.
10928170|NCT00702650|BG000|Baseline|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
10928171|NCT00702650|FG000|Participant Flow|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
10928172|NCT00702650|OG000|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
10928173|NCT00702650|EG000|Reported Event|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
10928174|NCT00702689|BG000|Baseline|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
10928175|NCT00702689|FG000|Participant Flow|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
10928176|NCT00702689|OG000|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
10928177|NCT00702689|EG000|Reported Event|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
10928178|NCT00702715|BG000|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
10928179|NCT00702715|BG001|Baseline|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
10928180|NCT00702715|BG002|Baseline|Total|Total of all reporting groups
10928181|NCT00702715|FG000|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 post-tetanic counts (PTC). Severe renal impairment was defined as creatinine clearance <30mL/min.
10928182|NCT00702715|FG001|Participant Flow|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
10928183|NCT00702715|OG000|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
10928184|NCT00702715|OG001|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
10928185|NCT00702715|EG000|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
10928186|NCT00702715|EG001|Reported Event|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
10928187|NCT00702754|BG000|Baseline|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
10928188|NCT00702754|FG000|Participant Flow|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
10928189|NCT00702754|OG000|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
10928190|NCT00702754|EG000|Reported Event|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
10928191|NCT00702780|BG000|Baseline|Escitalopram|escitalopram 20mg qd
10928192|NCT00702780|BG001|Baseline|Placebo|placebo 20mg qd
10928193|NCT00702780|BG002|Baseline|Total|Total of all reporting groups
10928194|NCT00702780|FG000|Participant Flow|Escitalopram|escitalopram 20mg qd
10928195|NCT00702780|FG001|Participant Flow|Placebo|placebo 20mg qd
10928196|NCT00702780|OG000|Outcome|Escitalopram|escitalopram 20mg qd
10928197|NCT00702780|OG001|Outcome|Placebo|placebo 20mg qd
10928198|NCT00702780|EG000|Reported Event|Escitalopram|Escitalopram 20mg qd
10928199|NCT00702780|EG001|Reported Event|Placebo|Placebo 20mg qd
10928200|NCT00702884|BG000|Baseline|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
10928201|NCT00702884|FG000|Participant Flow|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
10928202|NCT00702884|OG000|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
10928203|NCT00702884|OG000|Outcome|Grade 1 and 2 Adverse Events|"Grade 1=Mild; asymptomatic or mild symptoms~Grade 2=Moderate; minimal, local or noninvasive intervention indicated"
10928204|NCT00702884|OG001|Outcome|Grade 3 Adverse Events|Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated
10928205|NCT00702884|OG002|Outcome|Grade 4 Adverse Events|Grade 4=Life-threatening consequences; urgent intervention indicated
10928206|NCT00702884|EG000|Reported Event|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
10928207|NCT00702923|BG000|Baseline|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
10928208|NCT00702923|FG000|Participant Flow|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
10928209|NCT00702923|OG000|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
10928210|NCT00702923|OG001|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
10928211|NCT00702923|EG000|Reported Event|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
10928212|NCT00702949|BG000|Baseline|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
10928213|NCT00702949|BG001|Baseline|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
10928214|NCT00702949|BG002|Baseline|Placebo|Patients receive oral placebo twice daily for 6 weeks.
10928215|NCT00702949|BG003|Baseline|Total|Total of all reporting groups
10928216|NCT00702949|FG000|Participant Flow|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
10928217|NCT00702949|FG001|Participant Flow|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
10928218|NCT00702949|FG002|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 weeks.
10928219|NCT00702949|OG000|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
10928220|NCT00702949|OG001|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
10928221|NCT00702949|OG000|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
10928222|NCT00702949|OG001|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
10928223|NCT00702949|OG002|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
10928224|NCT00702949|EG000|Reported Event|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
10928225|NCT00702949|EG001|Reported Event|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
10928226|NCT00702949|EG002|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 weeks.
10928227|NCT00703053|BG000|Baseline|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928228|NCT00703053|BG001|Baseline|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928229|NCT00703053|BG002|Baseline|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928230|NCT00703053|BG003|Baseline|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928231|NCT00703053|BG004|Baseline|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
10928232|NCT00703053|BG005|Baseline|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928233|NCT00703053|BG006|Baseline|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928234|NCT00703053|BG007|Baseline|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928235|NCT00703053|BG008|Baseline|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928236|NCT00703053|BG009|Baseline|Total|Total of all reporting groups
10928237|NCT00703053|FG000|Participant Flow|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928238|NCT00703053|FG001|Participant Flow|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928239|NCT00703053|FG002|Participant Flow|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928240|NCT00703053|FG003|Participant Flow|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928241|NCT00703053|FG004|Participant Flow|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
10928242|NCT00703053|FG005|Participant Flow|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928243|NCT00703053|FG006|Participant Flow|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928244|NCT00703053|FG007|Participant Flow|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928245|NCT00703053|FG008|Participant Flow|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928246|NCT00703053|OG000|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928247|NCT00703053|OG001|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928248|NCT00703053|OG002|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928249|NCT00703053|OG003|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928250|NCT00703053|OG004|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
10928251|NCT00703053|OG005|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928252|NCT00703053|OG006|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928253|NCT00703053|OG007|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928254|NCT00703053|OG008|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928255|NCT00703053|OG007|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928256|NCT00703053|OG002|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928257|NCT00703053|EG000|Reported Event|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928258|NCT00703053|EG001|Reported Event|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928259|NCT00703053|EG002|Reported Event|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928260|NCT00703053|EG003|Reported Event|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928261|NCT00703053|EG004|Reported Event|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
10928262|NCT00703053|EG005|Reported Event|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928263|NCT00703053|EG006|Reported Event|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
10928264|NCT00703053|EG007|Reported Event|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928265|NCT00703053|EG008|Reported Event|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
10928266|NCT00703118|BG000|Baseline|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928267|NCT00703118|BG001|Baseline|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928268|NCT00703118|BG002|Baseline|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928269|NCT00703118|BG003|Baseline|Total|Total of all reporting groups
11175646|NCT02030574|FG000|Participant Flow|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
10928270|NCT00703118|FG000|Participant Flow|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928271|NCT00703118|FG001|Participant Flow|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928272|NCT00703118|FG002|Participant Flow|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928273|NCT00703118|OG000|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928274|NCT00703118|OG001|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928275|NCT00703118|OG002|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
10928276|NCT00703118|EG000|Reported Event|T12/PR48 - TVR/PBO TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
10928277|NCT00703118|EG001|Reported Event|T12(DS)/PR48 - TVR/PBO TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
10928278|NCT00703118|EG002|Reported Event|Pbo/PR48 - TVR/PBO TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
10928279|NCT00703118|EG003|Reported Event|T12/PR48 - OVERALL TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
10928280|NCT00703118|EG004|Reported Event|T12(DS)/PR48 - OVERALL TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
10928281|NCT00703118|EG005|Reported Event|Pbo/PR48 - OVERALL TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
10928282|NCT00703157|BG000|Baseline|Catheter|Catheter Ablation
10928283|NCT00703157|BG001|Baseline|Surgery|Surgical Ablation
10928284|NCT00703157|BG002|Baseline|Total|Total of all reporting groups
10928285|NCT00703157|FG000|Participant Flow|Catheter|Catheter Ablation
11175647|NCT02030574|OG000|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
11175648|NCT02030574|EG000|Reported Event|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
11175649|NCT02030600|BG000|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
10928286|NCT00703157|FG001|Participant Flow|Surgery|Surgical Ablation
10928287|NCT00703157|OG000|Outcome|Catheter|Catheter Ablation
10928288|NCT00703157|OG001|Outcome|Surgery|Surgical Ablation
10928289|NCT00703157|OG002|Outcome|All Subjects|All Subjects, regardless of randomization group
10928290|NCT00703157|EG000|Reported Event|Catheter|Catheter Ablation
10928291|NCT00703157|EG001|Reported Event|Surgery|Surgical Ablation
10928292|NCT00703157|EG002|Reported Event|All Randomized Subjects|All Randomized Subjects, regardless of randomization group
10928293|NCT00703261|BG000|Baseline|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
10928294|NCT00703261|BG001|Baseline|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
10928295|NCT00703261|BG002|Baseline|Total|Total of all reporting groups
10928296|NCT00703261|FG000|Participant Flow|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
10928297|NCT00703261|FG001|Participant Flow|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
10928298|NCT00703261|OG000|Outcome|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one matching 80 mg atorvastatin placebo tablet orally once daily for 12 weeks.
10928299|NCT00703261|OG001|Outcome|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one matching 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
10928300|NCT00703261|OG000|Outcome|Statin-Naive Participants|Participants self-administered one 10 mg or 80 mg atorvastatin tablet and one matching 80 mg or 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
10928301|NCT00703261|EG000|Reported Event|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
10928302|NCT00703261|EG001|Reported Event|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
10928303|NCT00703391|BG000|Baseline|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
10928304|NCT00703391|BG001|Baseline|Placebo|Matched placebo tablets twice daily (bid) for 14 days
10928305|NCT00703391|BG002|Baseline|Total|Total of all reporting groups
10928306|NCT00703391|FG000|Participant Flow|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
10928307|NCT00703391|FG001|Participant Flow|Placebo|Matched placebo tablets twice daily (bid) for 14 days
10928308|NCT00703391|OG000|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
10928309|NCT00703391|OG001|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
11175650|NCT02030600|BG001|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11175651|NCT02030600|BG002|Baseline|Total|Total of all reporting groups
10928310|NCT00703391|EG000|Reported Event|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
10928311|NCT00703391|EG001|Reported Event|Placebo|Matched placebo tablets twice daily (bid) for 14 days
10928312|NCT00703508|BG000|Baseline|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
10928313|NCT00703508|FG000|Participant Flow|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
10928314|NCT00703508|OG000|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
10928315|NCT00703508|OG001|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
10928316|NCT00703508|OG002|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
10928317|NCT00703508|EG000|Reported Event|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
10928318|NCT00703664|BG000|Baseline|Treatment: Cohort A - MCL; No Prior Bortezomib|Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically.
10928319|NCT00703664|BG001|Baseline|Treatment: Cohort B - MCL; Prior Bortezomib|Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically.
10928320|NCT00703664|BG002|Baseline|Treatment: Cohort C - DLBCL; No Prior Bortezomib|Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically.
10928321|NCT00703664|BG003|Baseline|Total|Total of all reporting groups
10928322|NCT00703664|FG000|Participant Flow|Treatment: Cohort A - MCL; No Prior Bortezomib|Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically.
10928323|NCT00703664|FG001|Participant Flow|Treatment: Cohort B - MCL; Prior Bortezomib|Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically.
10928324|NCT00703664|FG002|Participant Flow|Treatment: Cohort C - DLBCL; No Prior Bortezomib|Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically.
10928325|NCT00703664|OG000|Outcome|Cohort A - MCL|Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib).
10928326|NCT00703664|OG001|Outcome|Cohort B - MCL|Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib).
10928327|NCT00703664|OG002|Outcome|Cohort C - DLBCL|Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib).
10928328|NCT00703664|EG000|Reported Event|Cohort A - MCL|Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib).
10928329|NCT00703664|EG001|Reported Event|Cohort B - MCL|Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib).
11192076|NCT02136576|OG001|Outcome|Crest Cavity Protection & MI Paste Plus|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Crest Cavity Protection & MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger."
10928330|NCT00703664|EG002|Reported Event|Cohort C - DLBCL|Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib).
10928331|NCT00703677|BG000|Baseline|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
10928332|NCT00703677|FG000|Participant Flow|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
10928333|NCT00703677|OG000|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
10928334|NCT00703677|EG000|Reported Event|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
10928335|NCT00703729|BG000|Baseline|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
11175652|NCT02030600|FG000|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting self-measured plasma glucose (SMPG) values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11175653|NCT02030600|FG001|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11175654|NCT02030600|OG000|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
10928336|NCT00703729|BG001|Baseline|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
10928337|NCT00703729|BG002|Baseline|Total|Total of all reporting groups
10928338|NCT00703729|FG000|Participant Flow|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
10928339|NCT00703729|FG001|Participant Flow|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
10928340|NCT00703729|OG000|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
10928341|NCT00703729|OG001|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
10928342|NCT00703729|EG000|Reported Event|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
10928343|NCT00703729|EG001|Reported Event|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
10928344|NCT00703781|BG000|Baseline|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
10928345|NCT00703781|BG001|Baseline|Placebo|Placebo, Dosed 1 Drop Daily
10928346|NCT00703781|BG002|Baseline|Total|Total of all reporting groups
10928347|NCT00703781|FG000|Participant Flow|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
10928348|NCT00703781|FG001|Participant Flow|Placebo|Placebo, Dosed 1 Drop Daily
10928349|NCT00703781|OG000|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
10928350|NCT00703781|OG001|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
10928351|NCT00703781|EG000|Reported Event|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
10928352|NCT00703781|EG001|Reported Event|Placebo|Placebo, Dosed 1 Drop Daily
10928353|NCT00703820|BG000|Baseline|Cytarabine+Daunorubicin+Etoposide|Participants receive Cytarabine + Daunorubicin + Etoposide as a first course followed by risk-adapted therapy.
10928354|NCT00703820|BG001|Baseline|Clofarabine+Cytarabine|Participants receive Clofarabine + Cytarabine as a first course followed by risk-adapted therapy.
10928355|NCT00703820|BG002|Baseline|Total|Total of all reporting groups
10928356|NCT00703820|FG000|Participant Flow|Cytarabine+Daunorubicin+Etoposide|Participants receive Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
10928357|NCT00703820|FG001|Participant Flow|Clofarabine+Cytarabine|Participants receive Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
10928358|NCT00703820|OG000|Outcome|Cytarabine+Daunorubicin+Etoposide|Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
10928359|NCT00703820|OG001|Outcome|Clofarabine+Cytarabine|Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
10928360|NCT00703820|OG001|Outcome|Clofarabine+Cytarabine|Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk- adapted.
10928361|NCT00703820|EG000|Reported Event|Cytarabine+Daunorubicin+Etoposide|Participants received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
10928362|NCT00703820|EG001|Reported Event|Clofarabine+Cytarabine|Participants received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
10928363|NCT00703820|EG002|Reported Event|Stem Cell Donors|This group enrolled in the study to provide donor cells to participants. Donors did not receive therapy.
10928364|NCT00703846|BG000|Baseline|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
10928365|NCT00703846|FG000|Participant Flow|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. The maximum treatment period was 12 months.
10928366|NCT00703846|OG000|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
10928367|NCT00703846|EG000|Reported Event|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
10928368|NCT00703911|BG000|Baseline|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
10928369|NCT00703911|FG000|Participant Flow|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
10928370|NCT00703911|OG000|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
10928371|NCT00703911|EG000|Reported Event|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
10928372|NCT00703924|BG000|Baseline|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
10928373|NCT00703924|BG001|Baseline|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
10928374|NCT00703924|BG002|Baseline|Total|Total of all reporting groups
10928375|NCT00703924|FG000|Participant Flow|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
10928376|NCT00703924|FG001|Participant Flow|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
10928377|NCT00703924|OG000|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
10928378|NCT00703924|OG001|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
10928379|NCT00703924|OG000|Outcome|Day 20|100% Re-epithelialization by day 20
10928380|NCT00703924|OG001|Outcome|Day 50|100% Re-epithelialization by day 50
10928381|NCT00703924|OG002|Outcome|Day 100|100% Re-epithelialization by day 100
10928382|NCT00703924|OG003|Outcome|Day 180 (+7 Days)|100% Re-epithelialization by day 180 (+7 days)
10928383|NCT00703924|EG000|Reported Event|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
10928384|NCT00703924|EG001|Reported Event|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
10928385|NCT00703937|BG000|Baseline|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
10928386|NCT00703937|BG001|Baseline|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
11192077|NCT02136576|OG002|Outcome|Clinpro 5000|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study."
10928387|NCT00703937|BG002|Baseline|Total|Total of all reporting groups
10928388|NCT00703937|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
10928389|NCT00703937|FG001|Participant Flow|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
10928390|NCT00703937|OG000|Outcome|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
10928391|NCT00703937|OG001|Outcome|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
10928392|NCT00703937|EG000|Reported Event|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
10928393|NCT00703937|EG001|Reported Event|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
10928394|NCT00703963|BG000|Baseline|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
11192078|NCT02136576|EG000|Reported Event|Sensodyne|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study."
10928395|NCT00703963|BG001|Baseline|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
10928396|NCT00703963|BG002|Baseline|Total|Total of all reporting groups
10928397|NCT00703963|FG000|Participant Flow|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
10928398|NCT00703963|FG001|Participant Flow|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
10928399|NCT00703963|OG000|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
10928400|NCT00703963|OG001|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
10928401|NCT00703963|EG000|Reported Event|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
11175655|NCT02030600|OG001|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11175656|NCT02030600|OG000|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11175657|NCT02030600|OG001|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
10928402|NCT00703963|EG001|Reported Event|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
10928403|NCT00703976|BG000|Baseline|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
10928404|NCT00703976|BG001|Baseline|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
10928405|NCT00703976|BG002|Baseline|Total|Total of all reporting groups
10928406|NCT00703976|FG000|Participant Flow|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
10928407|NCT00703976|FG001|Participant Flow|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
10928408|NCT00703976|OG000|Outcome|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
10928409|NCT00703976|OG001|Outcome|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
10928410|NCT00703976|OG000|Outcome|All Participants (Overall Study)|
10928411|NCT00703976|OG001|Outcome|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
10928412|NCT00703976|OG002|Outcome|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
10928413|NCT00703976|EG000|Reported Event|All Participants (Overall Study)|
10928414|NCT00704028|BG000|Baseline|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
10928415|NCT00704028|BG001|Baseline|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
10928416|NCT00704028|BG002|Baseline|Total|Total of all reporting groups
10928417|NCT00704028|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
10928418|NCT00704028|FG001|Participant Flow|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
10928419|NCT00704028|OG000|Outcome|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
10928420|NCT00704028|OG001|Outcome|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
10928421|NCT00704028|EG000|Reported Event|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
10928422|NCT00704028|EG001|Reported Event|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
10928423|NCT00704132|BG000|Baseline|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
10928424|NCT00704132|BG001|Baseline|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
10928425|NCT00704132|BG002|Baseline|Total|Total of all reporting groups
10928426|NCT00704132|FG000|Participant Flow|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
10928427|NCT00704132|FG001|Participant Flow|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
10928428|NCT00704132|OG000|Outcome|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
10928429|NCT00704132|OG001|Outcome|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
10928430|NCT00704132|EG000|Reported Event|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
10928431|NCT00704132|EG001|Reported Event|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
10928432|NCT00704171|BG000|Baseline|PleuraSeal|PleuraSeal Lung Sealant System
10928433|NCT00704171|BG001|Baseline|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
10928434|NCT00704171|BG002|Baseline|Total|Total of all reporting groups
10928435|NCT00704171|FG000|Participant Flow|PleuraSeal|PleuraSeal Lung Sealant System
10928436|NCT00704171|FG001|Participant Flow|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
10928437|NCT00704171|OG000|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
10928438|NCT00704171|OG001|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
10928439|NCT00704171|EG000|Reported Event|PleuraSeal|PleuraSeal Lung Sealant System
11192079|NCT02136576|EG001|Reported Event|Crest Cavity Protection & MI Paste Plus|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Crest Cavity Protection & MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger."
10928440|NCT00704171|EG001|Reported Event|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
10928441|NCT00704184|BG000|Baseline|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928442|NCT00704184|BG001|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928443|NCT00704184|BG002|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928444|NCT00704184|BG003|Baseline|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928445|NCT00704184|BG004|Baseline|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928446|NCT00704184|BG005|Baseline|Total|Total of all reporting groups
10928447|NCT00704184|FG000|Participant Flow|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928448|NCT00704184|FG001|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928449|NCT00704184|FG002|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928450|NCT00704184|FG003|Participant Flow|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928451|NCT00704184|FG004|Participant Flow|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928452|NCT00704184|OG000|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928453|NCT00704184|OG001|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928454|NCT00704184|OG002|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928455|NCT00704184|OG003|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928456|NCT00704184|OG004|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928457|NCT00704184|EG000|Reported Event|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928458|NCT00704184|EG001|Reported Event|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928459|NCT00704184|EG002|Reported Event|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928460|NCT00704184|EG003|Reported Event|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928461|NCT00704184|EG004|Reported Event|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
10928462|NCT00704262|BG000|Baseline|Calcipotriol Plus Hydrocortisone (LEO 80190)|Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
10928463|NCT00704262|FG000|Participant Flow|Calcipotriol Plus Hydrocortisone (LEO 80190)|"Calcipotriol plus hydrocortisone (LEO 80190) ointment applied topically once daily for either 28 or 56 consecutive days on psoriasis vulgaris affected skin on the face and on the intertriginous areas.~The ointment was not to be applied in the 24-hour period before Day 28 and Day 56 to avoid interference from the hydrocortisone with the adrenocorticotrophic hormone (ACTH) challenge test. Treatment was to be resumed after Visit 3, where applicable.~The face was defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead was to be estimated considering the standard or previous hairline. The intertriginous areas were defined as the axillae, the genito-femoral and inguinal folds, the inframammary folds, the intergluteal folds, and scrotum."
10928464|NCT00704262|OG000|Outcome|Calcipotriol Plus Hydrocortisone (LEO 80190)|Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
10928465|NCT00704262|EG000|Reported Event|Calcipotriol Plus Hydrocortisone (LEO 80190)|Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
10928466|NCT00704340|BG000|Baseline|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
10928467|NCT00704340|BG001|Baseline|Control|Standard of Care (control)
10928468|NCT00704340|BG002|Baseline|Total|Total of all reporting groups
10928469|NCT00704340|FG000|Participant Flow|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
10928470|NCT00704340|FG001|Participant Flow|Control|Standard of Care (control)
10928471|NCT00704340|OG000|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
10928472|NCT00704340|OG001|Outcome|Control|Standard of Care (control)
10928473|NCT00704340|EG000|Reported Event|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
10928474|NCT00704340|EG001|Reported Event|Control|Standard of Care (control)
10928475|NCT00704353|BG000|Baseline|Ferric Carboxymaltose (FCM)|Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
10928476|NCT00704353|BG001|Baseline|Standard Medical Care|Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
10928477|NCT00704353|BG002|Baseline|Total|Total of all reporting groups
10928478|NCT00704353|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
10928479|NCT00704353|FG001|Participant Flow|Standard Medical Care|Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
10928480|NCT00704353|OG000|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
10928481|NCT00704353|OG001|Outcome|Standard Medical Care|Received standard medical care (as determined by the Investigator) of IDA.
10928482|NCT00704353|EG000|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
10928483|NCT00704353|EG001|Reported Event|Standard Medical Care|Received standard medical care (as determined by the Investigator) of IDA.
10963254|NCT00871143|BG001|Baseline|Non Specific CBT|Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.
10963255|NCT00871143|BG002|Baseline|Total|Total of all reporting groups
10963256|NCT00871143|FG000|Participant Flow|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
10963257|NCT00871143|FG001|Participant Flow|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits of anxiety management were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
10963258|NCT00871143|OG000|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
10963259|NCT00871143|OG001|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
10963260|NCT00871143|EG000|Reported Event|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
11192080|NCT02136576|EG002|Reported Event|Clinpro 5000|"There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.~Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study."
10928484|NCT00704379|BG000|Baseline|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
10928485|NCT00704379|BG001|Baseline|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
10928486|NCT00704379|BG002|Baseline|Total|Total of all reporting groups
10928487|NCT00704379|FG000|Participant Flow|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
10928488|NCT00704379|FG001|Participant Flow|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
10928489|NCT00704379|OG000|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
10928490|NCT00704379|OG001|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
10928491|NCT00704379|OG000|Outcome|Patients Who Developped a Mood or Anxiety Disorder|
10928492|NCT00704379|OG001|Outcome|Patients Who Did Not Developped a Mood or Anxiety Disorder|
10928493|NCT00704379|EG000|Reported Event|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
10928494|NCT00704379|EG001|Reported Event|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
10928495|NCT00704405|BG000|Baseline|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
10928496|NCT00704405|BG001|Baseline|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
10928497|NCT00704405|BG002|Baseline|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
10928498|NCT00704405|BG003|Baseline|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
10928499|NCT00704405|BG004|Baseline|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928500|NCT00704405|BG005|Baseline|Total|Total of all reporting groups
10928501|NCT00704405|FG000|Participant Flow|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
10928502|NCT00704405|FG001|Participant Flow|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
10928503|NCT00704405|FG002|Participant Flow|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
10928504|NCT00704405|FG003|Participant Flow|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
10928505|NCT00704405|FG004|Participant Flow|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928506|NCT00704405|OG000|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
10928507|NCT00704405|OG001|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
10928508|NCT00704405|OG002|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928509|NCT00704405|OG003|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928510|NCT00704405|OG002|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928511|NCT00704405|OG003|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928512|NCT00704405|OG004|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928513|NCT00704405|OG000|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928514|NCT00704405|OG001|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928515|NCT00704405|OG001|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928516|NCT00704405|OG002|Outcome|PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928517|NCT00704405|EG000|Reported Event|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
10928518|NCT00704405|EG001|Reported Event|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
10928519|NCT00704405|EG002|Reported Event|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
11175658|NCT02030600|EG000|Reported Event|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11175659|NCT02030600|EG001|Reported Event|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
11175660|NCT02030821|BG000|Baseline|Tranexamic Acid (TXA) - Total Hip Arthroplasty|"TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~TXA: Subjects randomized to receive TXA will receive this during surgical intervention"
11175661|NCT02030821|BG001|Baseline|Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty|"Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention"
10928520|NCT00704405|EG003|Reported Event|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
10928521|NCT00704405|EG004|Reported Event|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
10928522|NCT00704418|BG000|Baseline|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
10928523|NCT00704418|BG001|Baseline|Placebo|Placebo, dosed 1 drop daily
10928524|NCT00704418|BG002|Baseline|Total|Total of all reporting groups
10928525|NCT00704418|FG000|Participant Flow|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
10928526|NCT00704418|FG001|Participant Flow|Placebo|Placebo, dosed 1 drop daily
10928527|NCT00704418|OG000|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
10928528|NCT00704418|OG001|Outcome|Placebo|Placebo, dosed 1 drop daily
10928529|NCT00704418|EG000|Reported Event|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
10928530|NCT00704418|EG001|Reported Event|Placebo|Placebo, dosed 1 drop daily
10928531|NCT00704522|BG000|Baseline|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
10928532|NCT00704522|BG001|Baseline|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
10928533|NCT00704522|BG002|Baseline|Total|Total of all reporting groups
10928534|NCT00704522|FG000|Participant Flow|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
10928535|NCT00704522|FG001|Participant Flow|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
10928536|NCT00704522|OG000|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
11175662|NCT02030821|BG002|Baseline|Tranexamic Acid (TXA) - Total Knee Arthroplasty|"TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~TXA: Subjects randomized to receive TXA will receive this during surgical intervention"
11175663|NCT02030821|BG003|Baseline|Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty|"Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention"
11175664|NCT02030821|BG004|Baseline|Total|Total of all reporting groups
11175665|NCT02030821|FG000|Participant Flow|Tranexamic Acid (TXA) - Total Hip Arthroplasty|"TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~TXA: Subjects randomized to receive TXA will receive this during surgical intervention"
11175666|NCT02030821|FG001|Participant Flow|Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty|"Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention"
11175667|NCT02030821|FG002|Participant Flow|Tranexamic Acid (TXA) - Total Knee Arthroplasty|"TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~TXA: Subjects randomized to receive TXA will receive this during surgical intervention"
10928537|NCT00704522|OG001|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
10928538|NCT00704522|EG000|Reported Event|PegIntron Pen/Rebetol|
10928539|NCT00704717|BG000|Baseline|All Treated Patients|All patients participating in the study.
10928540|NCT00704717|FG000|Participant Flow|All Treated Patients|All patients participating in the study.
10928541|NCT00704717|OG000|Outcome|All Treated Patients|All patients participating in the study.
10928542|NCT00704717|EG000|Reported Event|All Treated Patients|All patients participating in the study.
10928543|NCT00704730|BG000|Baseline|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
10928544|NCT00704730|BG001|Baseline|Placebo|oral capsules once daily
10928545|NCT00704730|BG002|Baseline|Total|Total of all reporting groups
10928546|NCT00704730|FG000|Participant Flow|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
10928547|NCT00704730|FG001|Participant Flow|Placebo|oral capsules once daily
10928548|NCT00704730|OG000|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
10928549|NCT00704730|OG001|Outcome|Placebo|Oral capsules once daily
10928550|NCT00704730|OG000|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
10928551|NCT00704730|EG000|Reported Event|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
10928552|NCT00704730|EG001|Reported Event|Placebo|oral capsules once daily
10928553|NCT00704808|BG000|Baseline|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
10928554|NCT00704808|FG000|Participant Flow|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
10928555|NCT00704808|OG000|Outcome|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
10928556|NCT00704808|EG000|Reported Event|Temozolomide|
10928557|NCT00704847|BG000|Baseline|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
10928558|NCT00704847|BG001|Baseline|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
10928559|NCT00704847|BG002|Baseline|Total|Total of all reporting groups
10928560|NCT00704847|FG000|Participant Flow|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
10928561|NCT00704847|FG001|Participant Flow|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
10928562|NCT00704847|OG000|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
10928563|NCT00704847|OG001|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
10928564|NCT00704847|EG000|Reported Event|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
10928565|NCT00704847|EG001|Reported Event|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
10928566|NCT00704912|BG000|Baseline|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
10928567|NCT00704912|BG001|Baseline|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
10928568|NCT00704912|BG002|Baseline|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
10928569|NCT00704912|BG003|Baseline|Total|Total of all reporting groups
10928570|NCT00704912|FG000|Participant Flow|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
10928571|NCT00704912|FG001|Participant Flow|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
10928572|NCT00704912|FG002|Participant Flow|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
10928573|NCT00704912|OG000|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
10928574|NCT00704912|OG001|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
10928575|NCT00704912|OG002|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
10928576|NCT00704912|EG000|Reported Event|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
10928577|NCT00704912|EG001|Reported Event|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
10928578|NCT00704912|EG002|Reported Event|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
10928579|NCT00704938|BG000|Baseline|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
10928580|NCT00704938|BG001|Baseline|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
10928581|NCT00704938|BG002|Baseline|Total|Total of all reporting groups
10928582|NCT00704938|FG000|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
11192081|NCT02136680|BG000|Baseline|Patients at Intervention Site|Staff receives CASA Education: Basic palliative competencies for outpatient use.
11192082|NCT02136680|BG001|Baseline|Patients at CONTROL Site|Staff does not receive CASA Education: Patients at this site receive their usual care.
11192083|NCT02136680|BG002|Baseline|Total|Total of all reporting groups
10928583|NCT00704938|FG001|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
10928584|NCT00704938|OG000|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
10928585|NCT00704938|OG001|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
10928586|NCT00704938|EG000|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
10928587|NCT00704938|EG001|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
10928588|NCT00704964|BG000|Baseline|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
10928589|NCT00704964|FG000|Participant Flow|All Participants|"Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.~Completers are considered those with documentation who finished the study on time."
10928590|NCT00704964|OG000|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
10928591|NCT00704964|EG000|Reported Event|All Participants|
10928592|NCT00705003|BG000|Baseline|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
10928593|NCT00705003|BG001|Baseline|BCI-024|Buspirone 15 mg QD
10928594|NCT00705003|BG002|Baseline|Placebo|Placebo QD
10928595|NCT00705003|BG003|Baseline|Total|Total of all reporting groups
10928596|NCT00705003|FG000|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|1 over-encapsulated tablet of buspirone 15 mg and 1 over-encapsulated tablet of melatonin 3 mg QD
10928597|NCT00705003|FG001|Participant Flow|BCI-024 (Buspirone)|1 over-encapsulated tablet of buspirone 15 mg QD
10928598|NCT00705003|FG002|Participant Flow|Placebo|Matching placebo QD
10928599|NCT00705003|OG000|Outcome|BCI-024+BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
10928600|NCT00705003|OG001|Outcome|BCI-024|Buspirone 15 mg QD
10928601|NCT00705003|OG002|Outcome|Placebo|Placebo QD
10928602|NCT00705003|OG000|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
10928603|NCT00705003|EG000|Reported Event|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
10928604|NCT00705003|EG001|Reported Event|BCI-024|Buspirone 15 mg QD
10928605|NCT00705003|EG002|Reported Event|Placebo|Placebo QD
10928606|NCT00705016|BG000|Baseline|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928607|NCT00705016|BG001|Baseline|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928608|NCT00705016|BG002|Baseline|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928609|NCT00705016|BG003|Baseline|Total|Total of all reporting groups
10928610|NCT00705016|FG000|Participant Flow|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
11175668|NCT02030821|FG003|Participant Flow|Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty|"Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention"
10928611|NCT00705016|FG001|Participant Flow|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928612|NCT00705016|FG002|Participant Flow|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928613|NCT00705016|OG000|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928614|NCT00705016|OG001|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928615|NCT00705016|OG002|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928616|NCT00705016|EG000|Reported Event|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928617|NCT00705016|EG001|Reported Event|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928618|NCT00705016|EG002|Reported Event|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
10928619|NCT00705107|BG000|Baseline|All Treated Patients|
10928620|NCT00705107|FG000|Participant Flow|All Treated Patients|
11175669|NCT02030821|OG000|Outcome|Tranexamic Acid (TXA) - Total Hip Arthroplasty|"TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~TXA: Subjects randomized to receive TXA will receive this during surgical intervention"
10928621|NCT00705107|OG000|Outcome|All Treated Patients|
10928622|NCT00705107|EG000|Reported Event|All Treated Patients|
10928623|NCT00705133|BG000|Baseline|Treprostinil-treated|"Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion~Treprostinil: For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated"
10928624|NCT00705133|FG000|Participant Flow|Treprostinil-treated|"Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion~Treprostinil: For both subcutaneous (SQ) and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated"
10928625|NCT00705133|OG000|Outcome|Treprostinil-treated|"Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion~Treprostinil: For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated"
10928626|NCT00705133|EG000|Reported Event|Treprostinil-treated|"Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion~Treprostinil: For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated"
10928627|NCT00705146|BG000|Baseline|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
10928628|NCT00705146|BG001|Baseline|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
10928629|NCT00705146|BG002|Baseline|Total|Total of all reporting groups
10928630|NCT00705146|FG000|Participant Flow|Hybrid Splint 4 Weeks, 1 Week Washout, Then Comfort Cool Splin|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
10928631|NCT00705146|FG001|Participant Flow|Comfort Cool Splint 4 Weeks, 1 Week Washout, Then Hybrid Splin|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
10928632|NCT00705146|OG000|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
10928633|NCT00705146|OG001|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
10928634|NCT00705146|EG000|Reported Event|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
10928635|NCT00705146|EG001|Reported Event|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
10928636|NCT00705159|BG000|Baseline|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
10928637|NCT00705159|BG001|Baseline|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
10928638|NCT00705159|BG002|Baseline|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
10928639|NCT00705159|BG003|Baseline|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
10928640|NCT00705159|BG004|Baseline|Total|Total of all reporting groups
10928641|NCT00705159|FG000|Participant Flow|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
10928642|NCT00705159|FG001|Participant Flow|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
10928643|NCT00705159|FG002|Participant Flow|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
11357628|NCT03751657|BG000|Baseline|Insulin 287|Participants were to receive once weekly s.c. injection of insulin 287 using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once daily placebo for 26 weeks. The insulin dose was then adjusted once weekly to reach the glycaemic target of 3.9-6.0 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 3.0 mmol/L- dose reduced by 28 U, and 3.0-3.8- dose reduced by 14 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was: 3.9-6.0 mmol/L- no adjustment; 6.1-7.0 mmol/L- dose increased by 14U, and >7.0 mmol/L- dose increased by 28U. All participants used metformin with or without DPP4i at the stable, pre-trial dose and at the same frequency unless due to safety concerns.
11357629|NCT03751657|BG001|Baseline|Insulin Glargine|Participants were to receive once daily s.c injection of Insulin glargine using 10 ml vial and syringe at a starting dose of 10 U and once weekly placebo for 26 weeks. The insulin dose was then adjusted to reach the glycaemic target of 3.9-6.0 mmol/L based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 3.0 mmol/L- dose reduced by 4 U, and 3.0-3.8 dose reduced by 2 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was: 3.9-6.0 mmol/L- no adjustment; 6.1-7.0 mmol/L- dose increased by 2 U, and >7.0 mmol/L- dose increased by 4 U. All participants used metformin with or without DPP4i at the stable, pre-trial dose and at the same frequency unless due to safety concerns.
11357630|NCT03751657|BG002|Baseline|Total|Total of all reporting groups
11357631|NCT03751657|FG000|Participant Flow|Insulin 287|Participants were to receive once weekly s.c. injection of insulin 287 using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once daily placebo for 26 weeks. The insulin dose was then adjusted once weekly to reach the glycaemic target of 3.9-6.0 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 3.0 mmol/L- dose reduced by 28 U, and 3.0-3.8- dose reduced by 14 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was: 3.9-6.0 mmol/L- no adjustment; 6.1-7.0 mmol/L- dose increased by 14U, and >7.0 mmol/L- dose increased by 28U. All participants used metformin with or without DPP4i at the stable, pre-trial dose and at the same frequency unless due to safety concerns.
11357632|NCT03751657|FG001|Participant Flow|Insulin Glargine|Participants were to receive once daily s.c injection of Insulin glargine using 10 ml vial and syringe at a starting dose of 10 U and once weekly placebo for 26 weeks. The insulin dose was then adjusted to reach the glycaemic target of 3.9-6.0 mmol/L based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 3.0 mmol/L- dose reduced by 4 U, and 3.0-3.8 dose reduced by 2 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was: 3.9-6.0 mmol/L- no adjustment; 6.1-7.0 mmol/L- dose increased by 2 U, and >7.0 mmol/L- dose increased by 4 U. All participants used metformin with or without DPP4i at the stable, pre-trial dose and at the same frequency unless due to safety concerns.
10928644|NCT00705159|FG003|Participant Flow|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
10928645|NCT00705159|OG000|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
10928646|NCT00705159|OG001|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
10928647|NCT00705159|OG002|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
10928648|NCT00705159|OG003|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
10928649|NCT00705159|EG000|Reported Event|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
10928650|NCT00705159|EG001|Reported Event|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
10928651|NCT00705159|EG002|Reported Event|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
10928652|NCT00705159|EG003|Reported Event|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
10928653|NCT00705224|BG000|Baseline|Pegylated Interferon and Ribavirin|"Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
10928654|NCT00705224|FG000|Participant Flow|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C."
10928655|NCT00705224|OG000|Outcome|Pegylated Interferon and Ribavirin|Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
10928656|NCT00705224|OG000|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
10928657|NCT00705224|OG001|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
10928658|NCT00705224|OG000|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and a stage of hepatitis C.
10928659|NCT00705224|EG000|Reported Event|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
10928660|NCT00705250|BG000|Baseline|All Participants|
10928661|NCT00705250|FG000|Participant Flow|All Participants|Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion.
10928662|NCT00705250|OG000|Outcome|All Participants|
10928663|NCT00705250|EG000|Reported Event|All Participants|
10928664|NCT00705263|BG000|Baseline|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
10928665|NCT00705263|FG000|Participant Flow|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
10928666|NCT00705263|OG000|Outcome|Patients Treated With PegIntron Pen Plus Rebetol|
10928667|NCT00705263|EG000|Reported Event|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
10928668|NCT00705289|BG000|Baseline|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
10928669|NCT00705289|FG000|Participant Flow|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
10928670|NCT00705289|OG000|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
10928671|NCT00705289|OG001|Outcome|Male|
10928672|NCT00705289|OG002|Outcome|Female|
10928673|NCT00705289|OG000|Outcome|Austria|
10928674|NCT00705289|OG001|Outcome|Belgium|
10928675|NCT00705289|OG002|Outcome|Denmark|
10928676|NCT00705289|OG003|Outcome|France|
10928677|NCT00705289|OG004|Outcome|Germany|
10928678|NCT00705289|OG005|Outcome|Greece|
10928679|NCT00705289|OG006|Outcome|Italy|
10928680|NCT00705289|OG007|Outcome|Netherlands|
10928681|NCT00705289|OG008|Outcome|Norway|
10928682|NCT00705289|OG009|Outcome|Poland|
10928683|NCT00705289|OG010|Outcome|Portugal|
10928684|NCT00705289|OG011|Outcome|Sweden|
10928685|NCT00705289|OG001|Outcome|Early RA, Not Treated With Anti-TNF|Subjects with early RA not yet treated with an anti-TNF.
10928686|NCT00705289|OG002|Outcome|Established RA, Not Treated With Anti-TNF|Subjects with established RA not yet treated with an anti-TNF.
10928687|NCT00705289|OG003|Outcome|Established RA, Failed/Did Not Tolerate Another Anti-TNF|Subjects with established RA having failed or not tolerated another anti-TNF.
10928688|NCT00705289|EG000|Reported Event|Infliximab 3 mg/kg|
10928689|NCT00705341|BG000|Baseline|Nonasthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
10928690|NCT00705341|BG001|Baseline|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
10928691|NCT00705341|BG002|Baseline|Total|Total of all reporting groups
10928692|NCT00705341|FG000|Participant Flow|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
10928693|NCT00705341|FG001|Participant Flow|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
10928694|NCT00705341|FG002|Participant Flow|Low Dose, Then High Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2.
10928695|NCT00705341|FG003|Participant Flow|High Dose, Then Low Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2.
10928696|NCT00705341|OG000|Outcome|4 Weeks of High Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
10928697|NCT00705341|OG001|Outcome|4 Weeks of Low Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 250 mcg once daily
10928698|NCT00705341|OG000|Outcome|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
10928699|NCT00705341|OG001|Outcome|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
10928700|NCT00705341|EG000|Reported Event|Low Dose for phase1|4 weeks of Fluticasone (Flovent diskus) 250 mcg twice daily (500 mcg/day)
10928701|NCT00705341|EG001|Reported Event|High Dose for Phase 2|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
10928702|NCT00705367|BG000|Baseline|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
10928703|NCT00705367|BG001|Baseline|Placebo|Infusion, Intravenous, single dose, 24 hours
10928704|NCT00705367|BG002|Baseline|Total|Total of all reporting groups
10928705|NCT00705367|FG000|Participant Flow|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
10928706|NCT00705367|FG001|Participant Flow|Placebo/Abatacept,10 mg/kg|Short-term period: Participants received a single dose of placebo intravenously Long-term period: Placebo arm discontinued. All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
10928707|NCT00705367|OG000|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
10928708|NCT00705367|OG001|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
10928709|NCT00705367|OG000|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
10928710|NCT00705367|OG000|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
10928711|NCT00705367|EG000|Reported Event|Abatacept 30 mg/kg|
10928712|NCT00705367|EG001|Reported Event|Placebo|
10928713|NCT00705406|BG000|Baseline|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
10928714|NCT00705406|BG001|Baseline|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
10928715|NCT00705406|BG002|Baseline|Total|Total of all reporting groups
10928716|NCT00705406|FG000|Participant Flow|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
10928717|NCT00705406|FG001|Participant Flow|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
10928718|NCT00705406|OG000|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
10928719|NCT00705406|OG001|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
10928720|NCT00705406|OG001|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection
10928721|NCT00705406|EG000|Reported Event|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
10928722|NCT00705406|EG001|Reported Event|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
10928723|NCT00705432|BG000|Baseline|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928724|NCT00705432|BG001|Baseline|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
10928725|NCT00705432|BG002|Baseline|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928726|NCT00705432|BG003|Baseline|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928727|NCT00705432|BG004|Baseline|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
10928728|NCT00705432|BG005|Baseline|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928729|NCT00705432|BG006|Baseline|Total|Total of all reporting groups
10928730|NCT00705432|FG000|Participant Flow|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
11175670|NCT02030821|OG001|Outcome|Epsilon-aminocaproic Acid (Amicar)|"Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention"
10928731|NCT00705432|FG001|Participant Flow|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
10928732|NCT00705432|FG002|Participant Flow|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928733|NCT00705432|FG003|Participant Flow|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928734|NCT00705432|FG004|Participant Flow|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
10928735|NCT00705432|FG005|Participant Flow|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928736|NCT00705432|OG000|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
11240618|NCT02480764|OG001|Outcome|Azilsartan Medoxomil 80 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks.
10963261|NCT00871143|EG001|Reported Event|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
10928737|NCT00705432|OG001|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
10928738|NCT00705432|OG002|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928739|NCT00705432|OG003|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928740|NCT00705432|OG004|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
10928741|NCT00705432|OG005|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928742|NCT00705432|EG000|Reported Event|PEG + RBV|Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10928743|NCT00705432|EG001|Reported Event|BOCEPREVIR + PEG + RBV - 24 WEEKS|"Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
10928744|NCT00705432|EG002|Reported Event|BOCEPRIVIR + PEG + RBV - 44 WEEKS|Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
11175671|NCT02030821|OG002|Outcome|Tranexamic Acid (TXA) - Total Knee Arthroplasty|"TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~TXA: Subjects randomized to receive TXA will receive this during surgical intervention"
10928745|NCT00705484|BG000|Baseline|Remicade Group|Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion.
10928746|NCT00705484|BG001|Baseline|Standard Therapy Group|Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition.
10928747|NCT00705484|BG002|Baseline|Total|Total of all reporting groups
10928748|NCT00705484|FG000|Participant Flow|Remicade Group|Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion.
10928749|NCT00705484|FG001|Participant Flow|Standard Therapy Group|Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for Ulcerative Colitis (UC) or any other condition.
10928750|NCT00705484|OG000|Outcome|Remicade Group|Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion.
10928751|NCT00705484|OG001|Outcome|Standard Therapy Group|Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition.
10928752|NCT00705484|OG002|Outcome|Switched to Remicade Group|Participants who started the registry on standard therapy but subsequently switched to Remicade. AEs were counted after the switch to Remicade.
10928753|NCT00705484|EG000|Reported Event|Remicade Group|Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion.
10928754|NCT00705484|EG001|Reported Event|Standard Therapy Group|Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition.
10928755|NCT00705484|EG002|Reported Event|Switched to Remicade Group|Participants who started in the Standard Therapy Group but switched over to Remicade. AEs were counted after the switch to Remicade.
10928756|NCT00705523|BG000|Baseline|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
10928757|NCT00705523|BG001|Baseline|Placebo|placebo : BID 12 weeks
10928758|NCT00705523|BG002|Baseline|Total|Total of all reporting groups
10928759|NCT00705523|FG000|Participant Flow|Varenicline|varenicline : 1.0 mg BID for 12 weeks
10928760|NCT00705523|FG001|Participant Flow|Placebo|placebo : BID 12 weeks
10928761|NCT00705523|OG000|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
11175672|NCT02030821|OG003|Outcome|Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty|"Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention"
10928762|NCT00705523|OG001|Outcome|Placebo|placebo : BID 12 weeks
10928763|NCT00705523|EG000|Reported Event|Varenicline|varenicline : 1.0 mg BID for 12 weeks
10928764|NCT00705523|EG001|Reported Event|Placebo|placebo : BID 12 weeks
10928765|NCT00705536|BG000|Baseline|Stage 1: Humalog Alone or Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone or 20 U Humalog + 300 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
10928766|NCT00705536|BG001|Baseline|Stage 2: Humulin-R Alone or Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone or 20 U Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
10928767|NCT00705536|BG002|Baseline|Total|Total of all reporting groups
10928768|NCT00705536|FG000|Participant Flow|Stage 1: Humalog First, Then Humalog + rHuPH20|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog alone on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20).
10928769|NCT00705536|FG001|Participant Flow|Stage 1: Humalog + rHuPH20 First, Then Humalog|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog alone.
10928770|NCT00705536|FG002|Participant Flow|Stage 2: Humulin-R First, Then Humulin-R + rHuPH20|Stage 2 of the study: A single subcutaneous (SC) injection of 20 units (U) Humulin-R alone on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20).
10928771|NCT00705536|FG003|Participant Flow|Stage 2: Humulin-R + rHuPH20 First, Then Humulin-R|Stage 2 of the study. A single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R alone.
10928772|NCT00705536|OG000|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
10928773|NCT00705536|OG001|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
10928774|NCT00705536|OG002|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
10928775|NCT00705536|OG003|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
10928776|NCT00705536|OG000|Outcome|Stage 1. Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
10928777|NCT00705536|OG001|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) : A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U rHuPH20
10928778|NCT00705536|OG001|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
10928779|NCT00705536|OG002|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
10928780|NCT00705536|OG003|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
10928781|NCT00705536|OG000|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humalog and 300 U of rHuPH20
10928782|NCT00705536|OG001|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humulin-R and 240 U of rHuPH20
10928783|NCT00705536|OG002|Outcome|Stage 2: Humulin Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
10928784|NCT00705536|OG002|Outcome|Stage 2: Humulin-R Alone|Humulin: A single subcutaneous (SC) injection of 20 units (U)
10928785|NCT00705536|EG000|Reported Event|Stage 1: Humalog Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone during Stage 1 of the study
10928786|NCT00705536|EG001|Reported Event|Stage 1: Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase (rHuPH20) during Stage 1 of the study
10928787|NCT00705536|EG002|Reported Event|Stage 2: Humulin-R Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone during Stage 2 of the study
10928788|NCT00705536|EG003|Reported Event|Stage 2: Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20) during Stage 2 of the study
10928789|NCT00705575|BG000|Baseline|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
10928790|NCT00705575|BG001|Baseline|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
10928791|NCT00705575|BG002|Baseline|Total|Total of all reporting groups
10928792|NCT00705575|FG000|Participant Flow|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
10928793|NCT00705575|FG001|Participant Flow|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
10928794|NCT00705575|OG000|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
10928795|NCT00705575|OG001|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
10928796|NCT00705575|EG000|Reported Event|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
11240619|NCT02480764|OG002|Outcome|Valsartan 160 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks.
10928797|NCT00705575|EG001|Reported Event|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
10928798|NCT00705614|BG000|Baseline|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
10928799|NCT00705614|BG001|Baseline|Standard Therapy Group|The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
10928800|NCT00705614|BG002|Baseline|Total|Total of all reporting groups
10928801|NCT00705614|FG000|Participant Flow|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
10928802|NCT00705614|FG001|Participant Flow|Standard Therapy Group|"Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.~Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter."
10928803|NCT00705614|OG000|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
10928804|NCT00705614|OG001|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
10928805|NCT00705614|OG002|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
10928806|NCT00705614|EG000|Reported Event|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
10928807|NCT00705614|EG001|Reported Event|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
10928808|NCT00705614|EG002|Reported Event|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
10928809|NCT00705653|BG000|Baseline|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
10928810|NCT00705653|FG000|Participant Flow|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
10928811|NCT00705653|OG000|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
10928812|NCT00705653|EG000|Reported Event|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
10928813|NCT00705666|BG000|Baseline|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
10928814|NCT00705666|FG000|Participant Flow|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
10928815|NCT00705666|OG000|Outcome|PegIntron as Monotherapy or in Combination With Ribavirin|"Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.~The recommended treatment duration was 24 weeks for genotypes 2 and 3 and 48 weeks for genotype 1 according to the French 2002 consensus meeting.~The start and end dates of the treatment were collected in the questionnaire, so the actual treatment duration was calculated for each participant and compared to the theoretical treatment duration reported at Day 0 by the investigators."
10928816|NCT00705666|EG000|Reported Event|PegIntron as Monotherapy or in Combination With Ribavirin|
10928817|NCT00705679|BG000|Baseline|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
10928818|NCT00705679|BG001|Baseline|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
10928819|NCT00705679|BG002|Baseline|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
10928820|NCT00705679|BG003|Baseline|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
10928821|NCT00705679|BG004|Baseline|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
10928822|NCT00705679|BG005|Baseline|Total|Total of all reporting groups
10928823|NCT00705679|FG000|Participant Flow|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
10928824|NCT00705679|FG001|Participant Flow|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
10928825|NCT00705679|FG002|Participant Flow|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
10928826|NCT00705679|FG003|Participant Flow|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
10928827|NCT00705679|FG004|Participant Flow|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
10928828|NCT00705679|OG000|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
10928829|NCT00705679|OG001|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
10928830|NCT00705679|OG000|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
10928831|NCT00705679|OG001|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
10928832|NCT00705679|OG002|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
10928833|NCT00705679|OG003|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
10928834|NCT00705679|OG004|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
10928835|NCT00705679|OG000|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
10928836|NCT00705679|OG001|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
10928837|NCT00705679|OG000|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
10928838|NCT00705679|EG000|Reported Event|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
10928839|NCT00705679|EG001|Reported Event|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
10928840|NCT00705679|EG002|Reported Event|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
10928841|NCT00705679|EG003|Reported Event|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
10928842|NCT00705679|EG004|Reported Event|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
10928843|NCT00705718|BG000|Baseline|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
10928844|NCT00705718|BG001|Baseline|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
10928845|NCT00705718|BG002|Baseline|Total|Total of all reporting groups
10928846|NCT00705718|FG000|Participant Flow|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
10928847|NCT00705718|FG001|Participant Flow|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
10928848|NCT00705718|OG000|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
10928849|NCT00705718|OG001|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
11175673|NCT02030821|EG000|Reported Event|Tranexamic Acid (TXA) - Total Hip Arthroplasty|"TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~TXA: Subjects randomized to receive TXA will receive this during surgical intervention"
11175674|NCT02030821|EG001|Reported Event|Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty|"Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention"
11175675|NCT02030821|EG002|Reported Event|Tranexamic Acid (TXA) - Total Knee Arthroplasty|"TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~TXA: Subjects randomized to receive TXA will receive this during surgical intervention"
11175676|NCT02030821|EG003|Reported Event|Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty|"Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.~All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.~Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention"
11175677|NCT02030834|BG000|Baseline|Cohort A|"murine CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
10928850|NCT00705718|EG000|Reported Event|1. Endurant AUI Arm|Endurant Stent Graft System - Endurant AUI arm
10928851|NCT00705718|EG001|Reported Event|2. Endurant Bifurcated Arm|Endurant Stent Graft System - Endurant Bifurcated arm
10928852|NCT00705757|BG000|Baseline|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
10928853|NCT00705757|BG001|Baseline|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
11175678|NCT02030834|BG001|Baseline|Cohort B|"T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
11175679|NCT02030834|BG002|Baseline|Cohort C|"Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
11175680|NCT02030834|BG003|Baseline|Total|Total of all reporting groups
11175681|NCT02030834|FG000|Participant Flow|Cohort A|"murine CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
11175682|NCT02030834|FG001|Participant Flow|Cohort B|"T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
10928854|NCT00705757|BG002|Baseline|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
10928855|NCT00705757|BG003|Baseline|Total|Total of all reporting groups
10928856|NCT00705757|FG000|Participant Flow|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
10928857|NCT00705757|FG001|Participant Flow|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
10928858|NCT00705757|FG002|Participant Flow|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
10928859|NCT00705757|OG000|Outcome|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s).
10928860|NCT00705757|OG001|Outcome|Xalatan|Participants were assigned to use Xalatan ophthalmic solution one drop qhs for one year in affected eye(s).
10928861|NCT00705757|OG002|Outcome|Travatan|Participants were assigned to use Travatan ophthalmic solution one drop qhs for one year in affected eye(s).
10928862|NCT00705757|EG000|Reported Event|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
10928863|NCT00705757|EG001|Reported Event|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
10928864|NCT00705757|EG002|Reported Event|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
10928865|NCT00705783|BG000|Baseline|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
10928866|NCT00705783|BG001|Baseline|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
10928867|NCT00705783|BG002|Baseline|Total|Total of all reporting groups
10928868|NCT00705783|FG000|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the Depot Stabilization Phase, patients were stabilized on aripiprazole depot.
10928869|NCT00705783|FG001|Participant Flow|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
10928870|NCT00705783|FG002|Participant Flow|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
10928871|NCT00705783|OG000|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
10928872|NCT00705783|OG001|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
10928873|NCT00705783|EG000|Reported Event|Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
10928874|NCT00705783|EG001|Reported Event|Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
10928875|NCT00705783|EG002|Reported Event|Depot Stabilization Phase|During the IM Depot Stabilization Phase, patients were stabilized on aripiprazole IM depot.
10928876|NCT00705783|EG003|Reported Event|Aripiprazole Depot - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
10928877|NCT00705783|EG004|Reported Event|Placebo Depot - Depot Maintenance Phase|Patients received placebo intramuscularly every 28 days for 52 weeks.
10928878|NCT00705874|BG000|Baseline|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
10928879|NCT00705874|BG001|Baseline|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
10928880|NCT00705874|BG002|Baseline|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
10928881|NCT00705874|BG003|Baseline|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
10928882|NCT00705874|BG004|Baseline|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
10928883|NCT00705874|BG005|Baseline|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
10928884|NCT00705874|BG006|Baseline|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
10928885|NCT00705874|BG007|Baseline|Total|Total of all reporting groups
11175683|NCT02030834|FG002|Participant Flow|Cohort C|"Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
11175684|NCT02030834|OG000|Outcome|Cohort A|"murine CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
10928886|NCT00705874|FG000|Participant Flow|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
10928887|NCT00705874|FG001|Participant Flow|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
10928888|NCT00705874|FG002|Participant Flow|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
10928889|NCT00705874|FG003|Participant Flow|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
10928890|NCT00705874|FG004|Participant Flow|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
10928891|NCT00705874|FG005|Participant Flow|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
10928892|NCT00705874|FG006|Participant Flow|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
10928893|NCT00705874|OG000|Outcome|PG11047/Gemcitabine|PG-11047 in combination with Gemcitabine
10928894|NCT00705874|OG001|Outcome|PG11047/Docetaxel|PG-11047 in combination with Docetaxel
10928895|NCT00705874|OG002|Outcome|PG11047/Bevacizumab|PG-11047 in combination with Bevacizumab
10928896|NCT00705874|OG003|Outcome|PG11047/Erlotinib|PG-11047 in combination with Erlotinib
10928897|NCT00705874|OG004|Outcome|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
10928898|NCT00705874|OG005|Outcome|PG11047/5-Flurouracil|CGC-11047 in combination with 5-Flurouracil / Leucovorin
10928899|NCT00705874|OG006|Outcome|PG11047/Sunitinib|"PG-11047 in combination with Sunitinib.~The MTD of PG-11047 was undetermineable due to only 2 evaluable patients in this treatment group"
10928900|NCT00705874|EG000|Reported Event|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
10928901|NCT00705874|EG001|Reported Event|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
11175685|NCT02030834|OG001|Outcome|Cohort B|"T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
11175686|NCT02030834|OG002|Outcome|Cohort C|"Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
11175687|NCT02030834|EG000|Reported Event|Cohort A|"murine CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
11175688|NCT02030834|EG001|Reported Event|Cohort B|"T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
11175689|NCT02030834|EG002|Reported Event|Cohort C|"Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19~CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells)."
10928902|NCT00705874|EG002|Reported Event|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
10928903|NCT00705874|EG003|Reported Event|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
10928904|NCT00705874|EG004|Reported Event|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
10928905|NCT00705874|EG005|Reported Event|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
10928906|NCT00705874|EG006|Reported Event|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
10928907|NCT00705939|BG000|Baseline|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
10928908|NCT00705939|BG001|Baseline|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
10928909|NCT00705939|BG002|Baseline|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
10928910|NCT00705939|BG003|Baseline|Total|Total of all reporting groups
10928911|NCT00705939|FG000|Participant Flow|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
10928912|NCT00705939|FG001|Participant Flow|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
10928913|NCT00705939|FG002|Participant Flow|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
10928914|NCT00705939|OG000|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
10928915|NCT00705939|OG001|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
10928916|NCT00705939|OG002|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
10928917|NCT00705939|OG002|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
10928918|NCT00705939|EG000|Reported Event|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
10928919|NCT00705939|EG001|Reported Event|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
10928920|NCT00705939|EG002|Reported Event|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
10928921|NCT00706004|BG000|Baseline|Lubiprostone|24 micrograms twice daily
10928922|NCT00706004|FG000|Participant Flow|Lubiprostone|24 micrograms twice daily
10928923|NCT00706004|OG000|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
11175690|NCT02030847|BG000|Baseline|Arm1|"phase II study to determine the efficacy & safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART-19 cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.~CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10^8 transduced CAR T cells~CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10^7 CART-19 cells.~CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.~CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10^7), 30% on Day 2 (3x10^7-1.5x10^8), 60% on Day 3 (6x10^7-3x10^8"
11240620|NCT02480764|EG000|Reported Event|Azilsartan Medoxomil 40 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks.
10928924|NCT00706004|OG000|Outcome|Lubiprostone 24 Mcg Twice Daily|
10928925|NCT00706004|EG000|Reported Event|Lubiprostone|24 micrograms twice daily
10928926|NCT00706030|BG000|Baseline|Neratinib 160 mg + Vinorelbine 25 mg/m²|Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
10928927|NCT00706030|BG001|Baseline|Neratinib 240 mg + Vinorelbine 25 mg/m²|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
10928928|NCT00706030|BG002|Baseline|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
10928929|NCT00706030|BG003|Baseline|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
10928930|NCT00706030|BG004|Baseline|Total|Total of all reporting groups
10928931|NCT00706030|FG000|Participant Flow|Neratinib 160 mg + Vinorelbine 25 mg/m²|Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
10928932|NCT00706030|FG001|Participant Flow|Neratinib 240 mg + Vinorelbine 25 mg/m²|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
10928933|NCT00706030|FG002|Participant Flow|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
10928934|NCT00706030|FG003|Participant Flow|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
10928935|NCT00706030|OG000|Outcome|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
10928936|NCT00706030|OG001|Outcome|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
10928937|NCT00706030|OG000|Outcome|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure.
10928938|NCT00706030|OG001|Outcome|Neratinib 20 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure.
10928939|NCT00706030|OG000|Outcome|Part 1|Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with Vinorelbine 25 mg/m2 IV on days 1 and 8 every 3 weeks, associated with the dose limiting toxicity data.
10928940|NCT00706030|EG000|Reported Event|Neratinib 160 mg + Vinorelbine 25 mg/m²|Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks.
10928941|NCT00706030|EG001|Reported Event|Neratinib 240 mg + Vinorelbine 25 mg/m²|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks.
10928942|NCT00706030|EG002|Reported Event|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure.
10928943|NCT00706030|EG003|Reported Event|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure.
10928944|NCT00706095|BG000|Baseline|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
10928945|NCT00706095|BG001|Baseline|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
10928946|NCT00706095|BG002|Baseline|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
10928947|NCT00706095|BG003|Baseline|Total|Total of all reporting groups
10928948|NCT00706095|FG000|Participant Flow|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
10928949|NCT00706095|FG001|Participant Flow|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
10928950|NCT00706095|FG002|Participant Flow|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
10928951|NCT00706095|OG000|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
10928952|NCT00706095|OG001|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
10928953|NCT00706095|OG002|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
10928954|NCT00706095|EG000|Reported Event|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
10928955|NCT00706095|EG001|Reported Event|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
10928956|NCT00706095|EG002|Reported Event|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
10928957|NCT00706121|BG000|Baseline|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10928958|NCT00706121|BG001|Baseline|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10928959|NCT00706121|BG002|Baseline|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
10928960|NCT00706121|BG003|Baseline|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10928961|NCT00706121|BG004|Baseline|Total|Total of all reporting groups
10928962|NCT00706121|FG000|Participant Flow|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10928963|NCT00706121|FG001|Participant Flow|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10928964|NCT00706121|FG002|Participant Flow|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
10928965|NCT00706121|FG003|Participant Flow|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10928966|NCT00706121|OG000|Outcome|Active Selenium|Active Selenium +/- Vitamin E
10928967|NCT00706121|OG001|Outcome|Selenium Placebo|Selenium Placebo +/- Vitamin E
10928968|NCT00706121|OG000|Outcome|Active Selenium|Active selenium +/- Vitamin E
10928969|NCT00706121|OG001|Outcome|Selenium Placebo|Selenium placebo +/- Vitamin E
10928970|NCT00706121|OG000|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
10928971|NCT00706121|OG001|Outcome|Selenium|Selenium + matching placebo for vitamin E
10928972|NCT00706121|OG002|Outcome|Combination|Vitamin E + selenium
10928973|NCT00706121|OG003|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
10928974|NCT00706121|OG000|Outcome|Active Selenium|Active selenium +/- vitamin E
10928975|NCT00706121|OG001|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
10928976|NCT00706121|OG000|Outcome|Active Vitamin E|Active vitamin E +/- selenium
10928977|NCT00706121|OG001|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
10928978|NCT00706121|EG000|Reported Event|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10928979|NCT00706121|EG001|Reported Event|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10928980|NCT00706121|EG002|Reported Event|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
10928981|NCT00706121|EG003|Reported Event|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10928982|NCT00706134|BG000|Baseline|Placebo|Placebo tablet taken once daily in the morning with a light meal.
10928983|NCT00706134|BG001|Baseline|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
10928984|NCT00706134|BG002|Baseline|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
10928985|NCT00706134|BG003|Baseline|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
10928986|NCT00706134|BG004|Baseline|Total|Total of all reporting groups
10928987|NCT00706134|FG000|Participant Flow|Placebo|Placebo tablet taken once daily in the morning with a light meal.
10928988|NCT00706134|FG001|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
10928989|NCT00706134|FG002|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
10928990|NCT00706134|FG003|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
10928991|NCT00706134|OG000|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
10928992|NCT00706134|OG001|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
10928993|NCT00706134|OG002|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
10928994|NCT00706134|OG003|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
10928995|NCT00706134|EG000|Reported Event|Placebo|Placebo tablet taken once daily in the morning with a light meal.
10928996|NCT00706134|EG001|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
10928997|NCT00706134|EG002|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
10928998|NCT00706134|EG003|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
10928999|NCT00706238|BG000|Baseline|GSK1203486A Group|Patients received 4 cycles of MAGE-A3 product as follows: - Cycle 1: 6 doses, each given at a 2-week interval, - Cycle 2: 6 doses, each given at a 3-week interval - Cycle 3: 4 doses, each given at a 6-week interval - Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval. The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
10929000|NCT00706238|FG000|Participant Flow|GSK1203486A Group|Patients received 4 cycles of MAGE-A3 product as follows: - Cycle 1: 6 doses, each given at a 2-week interval, - Cycle 2: 6 doses, each given at a 3-week interval - Cycle 3: 4 doses, each given at a 6-week interval - Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval. The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
10929001|NCT00706238|OG000|Outcome|GSK1203486A Group|Patients received 4 cycles of MAGE-A3 product as follows: - Cycle 1: 6 doses, each given at a 2-week interval, - Cycle 2: 6 doses, each given at a 3-week interval - Cycle 3: 4 doses, each given at a 6-week interval - Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval. The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
10929002|NCT00706238|EG000|Reported Event|GSK1203486A Group|Patients received 4 cycles of MAGE-A3 product as follows: - Cycle 1: 6 doses, each given at a 2-week interval, - Cycle 2: 6 doses, each given at a 3-week interval - Cycle 3: 4 doses, each given at a 6-week interval - Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval. The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
10929003|NCT00706264|BG000|Baseline|Expectant Management|Both groups were seen by the clinical team of the trial at each centre every month until delivery. Transabdominal ultrasonography was done for fetal biometries and wellbeing, clinical questionnaire was administered for confi rmation of correct device placement in the pessary group (fi gure 2), vaginal swab was taken for study of bacteriological infection, and transvaginal ultra sonography was done to measure cervical length (fi gure 3)
10929004|NCT00706264|BG001|Baseline|Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks|The pessary was removed during the 37th week of gestation. Indications for pessary removal before this time were active vaginal bleeding, risk of preterm labour with persistent contractions despite tocolysis, or severe patient discomfort.
10929005|NCT00706264|BG002|Baseline|Total|Total of all reporting groups
10929006|NCT00706264|FG000|Participant Flow|Expectant Management|Expectant management: Current conventional management.
10929007|NCT00706264|FG001|Participant Flow|Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks|"Placement of arabin pessary since 23 weeks until 37 weeks~Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix."
10929008|NCT00706264|OG000|Outcome|No Intervention: No Pessary|No pessary will be used. Subjects will receive standard obstetrical care and management.
10929009|NCT00706264|OG001|Outcome|Experimental: Pessary|Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
10929010|NCT00706264|OG000|Outcome|Expectant Management|Expectant management: usual management
10929011|NCT00706264|OG001|Outcome|Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks|Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.
10929012|NCT00706264|EG000|Reported Event|Expectant Management|Expectant management: usual management
10929013|NCT00706264|EG001|Reported Event|Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks|Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.
10929014|NCT00706342|BG000|Baseline|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
11175691|NCT02030847|FG000|Participant Flow|Arm1|"Phase II study to determine the efficacy & safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART-19 cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.~CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10^8 transduced CAR T cells~CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10^7 CART-19 cells.~CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.~CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10^7), 30% on Day 2 (3x10^7-1.5x10^8), 60% on Day 3 (6x10^7-3x10^8"
10929015|NCT00706342|FG000|Participant Flow|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
10929016|NCT00706342|OG000|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
11240621|NCT02480764|EG001|Reported Event|Azilsartan Medoxomil 80 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks.
10929017|NCT00706342|EG000|Reported Event|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
10929018|NCT00706355|BG000|Baseline|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929019|NCT00706355|BG001|Baseline|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929020|NCT00706355|BG002|Baseline|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929021|NCT00706355|BG003|Baseline|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929022|NCT00706355|BG004|Baseline|Total|Total of all reporting groups
10929023|NCT00706355|FG000|Participant Flow|PF-04217903 50 mg|Two tablets 25 milligram (mg) PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929024|NCT00706355|FG001|Participant Flow|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929025|NCT00706355|FG002|Participant Flow|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929026|NCT00706355|FG003|Participant Flow|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929027|NCT00706355|OG000|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
10929028|NCT00706355|OG000|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929029|NCT00706355|OG001|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929030|NCT00706355|OG002|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929031|NCT00706355|OG003|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929032|NCT00706355|OG002|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929033|NCT00706355|EG000|Reported Event|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929034|NCT00706355|EG001|Reported Event|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929035|NCT00706355|EG002|Reported Event|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929036|NCT00706355|EG003|Reported Event|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
10929037|NCT00706381|BG000|Baseline|1: Carb Meal, Fat Meal, Sincalide, Placebo, Urso|Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, and IV placebo + PO Ursodiol 15mg/kg day 5
10929038|NCT00706381|BG001|Baseline|2: Fat Meal, Carb Meal, Sincalide, Placebo, Urso|Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5
10929039|NCT00706381|BG002|Baseline|3: Carb Meal, Fat Meal, Placebo, Sincalide, Urso|Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5
10929040|NCT00706381|BG003|Baseline|4: Fat Meal, Carb Meal, Placebo, Sincalide, Urso|Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, the IV placebo + PO Ursodiol 15mg/kg day 5
10929041|NCT00706381|BG004|Baseline|Total|Total of all reporting groups
10929042|NCT00706381|FG000|Participant Flow|1: Carb Meal, Fat Meal, Sincalide, Placebo, Urso|Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, and IV placebo + PO Ursodiol 15mg/kg day 5
10929043|NCT00706381|FG001|Participant Flow|2: Fat Meal, Carb Meal, Sincalide, Placebo, Urso|Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5
10929044|NCT00706381|FG002|Participant Flow|3: Carb Meal, Fat Meal, Placebo, Sincalide, Urso|Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5
10929045|NCT00706381|FG003|Participant Flow|4: Fat Meal, Carb Meal, Placebo, Sincalide, Urso|Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, the IV placebo + PO Ursodiol 15mg/kg day 5
10929046|NCT00706381|OG000|Outcome|Carb Meal|All participants who completed the carbohydrate meal and placebo portions of the study
10929047|NCT00706381|OG001|Outcome|Fat Meal|All participants who completed the high fat meal and placebo portions of the study
10929048|NCT00706381|OG002|Outcome|Sincalide|All participants who completed the sincalide and placebo portions of the study
10929049|NCT00706381|OG003|Outcome|Ursodiol|All participants who completed the ursodiol and placebo portions of the study
10929050|NCT00706381|OG004|Outcome|Placebo|All participants who completed the sincalide portion of the study
10929051|NCT00706381|OG004|Outcome|Placebo|All participants who completed the placebo portion of the study
10929052|NCT00706381|EG000|Reported Event|Carb Meal|All participants who completed the carbohydrate meal portion of the study
10929053|NCT00706381|EG001|Reported Event|Fat Meall|All participants who completed the high fat meal portion of the study
10929054|NCT00706381|EG002|Reported Event|Sincalide|All participants who completed the sincalide portion of the study
10929055|NCT00706381|EG003|Reported Event|Ursodiol|all participants who completed the ursodiol portion of the study
10929056|NCT00706381|EG004|Reported Event|Placebo|Oral and IV Placebo
10929057|NCT00706394|BG000|Baseline|Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy|"Powerlink 34mm cuff stent graft~Endologix Powerlink 34 mm stent graft cuff: Endovascular abdominal aortic aneurysm repair"
10929058|NCT00706394|FG000|Participant Flow|Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy|"Powerlink 34mm cuff stent graft~Endologix Powerlink 34 mm stent graft cuff: Endovascular abdominal aortic aneurysm repair"
10929059|NCT00706394|OG000|Outcome|Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy|"Powerlink 34mm cuff stent graft~Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair"
10929060|NCT00706394|EG000|Reported Event|Powerlink 34mm Cuff Stent Graft|"Powerlink 34mm cuff stent graft~Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair"
10929061|NCT00706407|BG000|Baseline|Obstructed|All patients who had data analyzed
10929062|NCT00706407|BG001|Baseline|Unobstructed|Patients with obstruction
10929063|NCT00706407|BG002|Baseline|Total|Total of all reporting groups
10929064|NCT00706407|FG000|Participant Flow|Fully Integrated Uro-NIRS:UDS|As part of standard care subjects will be undergoing a standard bladder pressure diagnostic procedure. This standard procedure will involve the insertion of a catheter (a plastic tube) into the urethra and the measurement of pressure within the bladder. For subjects taking part in this study, the health of the bladder will measured by using light instead of pressure. A patch, the size of cell phone or deck of playing cards, will be taped to the skin in the middle of the abdomen, above the bladder. Using laser light that is 300 billion times weaker than the light from a regular household 100-Watt light bulb, the Laborie and Urodynamic device will take measurements through the skin without inserting anything into the body.
10929065|NCT00706407|OG000|Outcome|Number Obstructed|Free Flow and pressure flow NIRS patterns
10929066|NCT00706407|OG001|Outcome|Number Unobstructed|Free Flow and Pressure flow NIRS patterns
10929067|NCT00706407|OG002|Outcome|Totals|Total number of participants included
10929068|NCT00706407|EG000|Reported Event|Obstructed|Those with BOO
10929069|NCT00706407|EG001|Reported Event|Unobstructed|Those without BOO
10929070|NCT00706433|BG000|Baseline|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
10929071|NCT00706433|BG001|Baseline|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
10929072|NCT00706433|BG002|Baseline|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
10929073|NCT00706433|BG003|Baseline|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
10929074|NCT00706433|BG004|Baseline|Total|Total of all reporting groups
10929075|NCT00706433|FG000|Participant Flow|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
10929076|NCT00706433|FG001|Participant Flow|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
10929077|NCT00706433|FG002|Participant Flow|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
10929078|NCT00706433|FG003|Participant Flow|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
10929079|NCT00706433|OG000|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
11175692|NCT02030847|OG000|Outcome|Arm1|"phase II study to determine the efficacy & safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART-19 cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.~CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10^8 transduced CAR T cells~CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10^7 CART-19 cells.~CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.~CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10^7), 30% on Day 2 (3x10^7-1.5x10^8), 60% on Day 3 (6x10^7-3x10^8"
10929080|NCT00706433|OG001|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
10929081|NCT00706433|OG002|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
10929082|NCT00706433|OG003|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
10929083|NCT00706433|EG000|Reported Event|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
10929084|NCT00706433|EG001|Reported Event|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
10929085|NCT00706433|EG002|Reported Event|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
10929086|NCT00706433|EG003|Reported Event|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
10929087|NCT00706446|BG000|Baseline|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
10929088|NCT00706446|BG001|Baseline|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
10929089|NCT00706446|BG002|Baseline|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
10929090|NCT00706446|BG003|Baseline|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929091|NCT00706446|BG004|Baseline|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929092|NCT00706446|BG005|Baseline|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929093|NCT00706446|BG006|Baseline|Total|Total of all reporting groups
10929094|NCT00706446|FG000|Participant Flow|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
10929095|NCT00706446|FG001|Participant Flow|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
10929096|NCT00706446|FG002|Participant Flow|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
10963262|NCT00871169|BG000|Baseline|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
11240622|NCT02480764|EG002|Reported Event|Valsartan 160 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks.
10929097|NCT00706446|FG003|Participant Flow|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929098|NCT00706446|FG004|Participant Flow|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929099|NCT00706446|FG005|Participant Flow|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929100|NCT00706446|OG000|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
10929101|NCT00706446|OG001|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
10929102|NCT00706446|OG002|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
10963263|NCT00871169|FG000|Participant Flow|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
11240623|NCT02480920|BG000|Baseline|Study Population|"This multicenter cross-sectional study was consisted of patients who with non-valvular atrial fibrillation (NVAF) receiving Non-vitamin K antagonist oral anticoagulants NOACs), older than 18 years, who were followed up in cardiology clinics, and who received dabigatran (110-150 mg), rivaroxaban (15-20 mg), or apixaban (2.5-5 mg) for the last 3 months with >30 days of supply due to NVAF.~The patients were categorized into 2 groups as adherent patients who had high and medium adherence (Morisky score 6 or more) and non-adherent patients who had low adherence (Morisky score 5 or less)."
10929103|NCT00706446|OG003|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929104|NCT00706446|OG004|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929105|NCT00706446|OG005|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
10929106|NCT00706446|EG000|Reported Event|1 - Tio/ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
10929107|NCT00706446|EG001|Reported Event|2 - Tio/ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
10929108|NCT00706446|EG002|Reported Event|3 - Tio/ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
10929109|NCT00706446|EG003|Reported Event|4 - LABA/ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
10929110|NCT00706446|EG004|Reported Event|5 - LABA/ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
10929111|NCT00706446|EG005|Reported Event|6 - LABA/ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
10929112|NCT00706485|BG000|Baseline|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
10929113|NCT00706485|FG000|Participant Flow|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
10929114|NCT00706485|OG000|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
10929115|NCT00706485|EG000|Reported Event|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
10929116|NCT00706511|BG000|Baseline|Men With OSA|"Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.~CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks"
10929117|NCT00706511|BG001|Baseline|Women With OSA|"Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.~CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks"
10929118|NCT00706511|BG002|Baseline|Men Without OSA|Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
10929119|NCT00706511|BG003|Baseline|Women Without OSA|Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
10929120|NCT00706511|BG004|Baseline|Total|Total of all reporting groups
10929121|NCT00706511|FG000|Participant Flow|Men With OSA|"Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.~CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks"
10929122|NCT00706511|FG001|Participant Flow|Women With OSA|"Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.~CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks"
10929123|NCT00706511|FG002|Participant Flow|Men Without OSA|Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
10929124|NCT00706511|FG003|Participant Flow|Women Without OSA|Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
10929125|NCT00706511|OG000|Outcome|Men With OSA|"Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.~CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks"
10929126|NCT00706511|OG001|Outcome|Women With OSA|"Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.~CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks"
10929127|NCT00706511|OG002|Outcome|Men Without OSA|Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
10929128|NCT00706511|OG003|Outcome|Women Without OSA|Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
10929129|NCT00706511|EG000|Reported Event|Group With OSA|"Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.~CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks"
10929130|NCT00706511|EG001|Reported Event|Group Without OSA|Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
10929131|NCT00706550|BG000|Baseline|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
10929132|NCT00706550|BG001|Baseline|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
10929133|NCT00706550|BG002|Baseline|Total|Total of all reporting groups
10929134|NCT00706550|FG000|Participant Flow|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
10929135|NCT00706550|FG001|Participant Flow|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
10929136|NCT00706550|OG000|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
10929137|NCT00706550|OG001|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
10929138|NCT00706550|OG000|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
10929139|NCT00706550|EG000|Reported Event|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
10929140|NCT00706550|EG001|Reported Event|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
10929141|NCT00706563|BG000|Baseline|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
10929142|NCT00706563|BG001|Baseline|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
10929143|NCT00706563|BG002|Baseline|Total|Total of all reporting groups
10929144|NCT00706563|FG000|Participant Flow|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
10929145|NCT00706563|FG001|Participant Flow|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
10929146|NCT00706563|OG000|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
10929147|NCT00706563|OG001|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
10929148|NCT00706563|EG000|Reported Event|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
10929149|NCT00706563|EG001|Reported Event|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
10929150|NCT00706589|BG000|Baseline|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
11240624|NCT02480920|FG000|Participant Flow|Study Popülation: Who Received NOAC for More Than 3 Months|This multicenter cross-sectional study was conducted between September 2015 and February 2016 in 45 centers encompassing all the geographical regions of Turkey. A total of 3150 patients were evaluated in this study. The 163 patients with a sociocultural level inadequate to fill the questionnaire and the 249 patients who received new oral anticoagulant for less than 3 months were excluded from the study. This study was conducted with the remaining 2738 patients.
10929151|NCT00706589|BG001|Baseline|Placebo|Placebo 2mg,5mg,10mg,15mg
10929152|NCT00706589|BG002|Baseline|Total|Total of all reporting groups
10929153|NCT00706589|FG000|Participant Flow|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O
10929154|NCT00706589|FG001|Participant Flow|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O
10929155|NCT00706589|OG000|Outcome|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg
10929156|NCT00706589|OG001|Outcome|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg
10929157|NCT00706589|EG000|Reported Event|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
10929158|NCT00706589|EG001|Reported Event|Placebo|Placebo 2mg,5mg,10mg,15mg
10929159|NCT00706628|BG000|Baseline|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
10929160|NCT00706628|BG001|Baseline|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
10929161|NCT00706628|BG002|Baseline|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
10929162|NCT00706628|BG003|Baseline|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
10929163|NCT00706628|BG004|Baseline|Total|Total of all reporting groups
10929164|NCT00706628|FG000|Participant Flow|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
10929165|NCT00706628|FG001|Participant Flow|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
10929166|NCT00706628|FG002|Participant Flow|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
10929167|NCT00706628|FG003|Participant Flow|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events (AE) reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
10929168|NCT00706628|OG000|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
10929169|NCT00706628|OG001|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
10929170|NCT00706628|OG002|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
10929171|NCT00706628|OG003|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle. The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged. Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
10929172|NCT00706628|OG002|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
10929173|NCT00706628|OG003|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
10929174|NCT00706628|OG000|Outcome|Combination Therapy of BIBF 1120 and BIBW 2992|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~C12,14 values of BIBF 1120 BS after sequential alternating 7-days administration of 250 mg BIBF 1120 bid;~C24,7, C24,14 and C24,42 values of BIBW 2992 BS after sequential alternating 7-days administration of 40 mg BIBW 2992 qd"
11175693|NCT02030847|OG000|Outcome|Arm1|"Phase II study to determine the efficacy & safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART-19 cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.~CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10^8 transduced CAR T cells~CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10^7 CART-19 cells.~CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.~CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10^7), 30% on Day 2 (3x10^7-1.5x10^8), 60% on Day 3 (6x10^7-3x10^8)."
10929175|NCT00706628|EG000|Reported Event|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
10929176|NCT00706628|EG001|Reported Event|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
10929177|NCT00706628|EG002|Reported Event|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
10929178|NCT00706628|EG003|Reported Event|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
10929179|NCT00706641|BG000|Baseline|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
10929180|NCT00706641|FG000|Participant Flow|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
10929181|NCT00706641|OG000|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
10929182|NCT00706641|EG000|Reported Event|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
10929183|NCT00706654|BG000|Baseline|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
10929184|NCT00706654|BG001|Baseline|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
10929185|NCT00706654|BG002|Baseline|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
10929186|NCT00706654|BG003|Baseline|Total|Total of all reporting groups
10929187|NCT00706654|FG000|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy and during the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
10929188|NCT00706654|FG001|Participant Flow|Aripiprazole Depot 300 or 400 mg|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
10929189|NCT00706654|FG002|Participant Flow|Aripiprazole 10-30 mg Orally|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
10929190|NCT00706654|FG003|Participant Flow|Aripiprazole Depot 25 or 50 mg|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
10929191|NCT00706654|OG000|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
10929192|NCT00706654|OG001|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
10929193|NCT00706654|OG002|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
10929194|NCT00706654|EG000|Reported Event|All Patients - Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
10929195|NCT00706654|EG001|Reported Event|All Patients - Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
10929196|NCT00706654|EG002|Reported Event|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
10929197|NCT00706654|EG003|Reported Event|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
10929198|NCT00706654|EG004|Reported Event|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
10929199|NCT00706706|BG000|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
10929200|NCT00706706|FG000|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
10929201|NCT00706706|OG000|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
10929202|NCT00706706|EG000|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
10929203|NCT00706719|BG000|Baseline|Group A Testim|1% Testim gel applied daily
10929204|NCT00706719|BG001|Baseline|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
10929205|NCT00706719|BG002|Baseline|Group C Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
10929206|NCT00706719|BG003|Baseline|Total|Total of all reporting groups
10929207|NCT00706719|FG000|Participant Flow|Group A Testim (Topical Testosterone)|1% Testim gel applied once daily
10929208|NCT00706719|FG001|Participant Flow|Group B Androxal no Washout|25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone
10929209|NCT00706719|FG002|Participant Flow|Group C Androxal With Wash Out|25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone
10929210|NCT00706719|OG000|Outcome|Group A Testim|1% Testim gel applied daily
10929211|NCT00706719|OG001|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
10929212|NCT00706719|EG000|Reported Event|Group A Testim|1% Testim gel applied daily
11377043|NCT00346164|BG003|Baseline|Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
10929213|NCT00706719|EG001|Reported Event|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
10929214|NCT00706719|EG002|Reported Event|Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
10929215|NCT00706784|BG000|Baseline|18 mg Leuprolide for 3 Days|
10929216|NCT00706784|BG001|Baseline|36 mg Leuprolide for 3 Days|
10929217|NCT00706784|BG002|Baseline|Total|Total of all reporting groups
10929218|NCT00706784|FG000|Participant Flow|18 mg Leuprolide for 3 Days|
10929219|NCT00706784|FG001|Participant Flow|36 mg Leuprolide for 3 Days|
10929220|NCT00706784|OG000|Outcome|18 mg Leuprolide for 3 Days|
10929221|NCT00706784|OG001|Outcome|36 mg Leuprolide for 3 Days|
10929222|NCT00706784|EG000|Reported Event|18 mg Leuprolide for 3 Days|
10929223|NCT00706784|EG001|Reported Event|36 mg Leuprolide for 3 Days|
10929224|NCT00706810|BG000|Baseline|All Groups|
10929225|NCT00706810|FG000|Participant Flow|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
10929226|NCT00706810|OG000|Outcome|All Groups|
10929227|NCT00706810|OG000|Outcome|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
10929228|NCT00706810|EG000|Reported Event|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
10929229|NCT00706823|BG000|Baseline|I-gel-SGA|Patients who received i-gel SGA for intubation
10929230|NCT00706823|BG001|Baseline|LMA-Unique|Patients who received LMA-Unique for intubation
10929231|NCT00706823|BG002|Baseline|Total|Total of all reporting groups
10929232|NCT00706823|FG000|Participant Flow|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
10929233|NCT00706823|FG001|Participant Flow|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
10929234|NCT00706823|OG000|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
10929235|NCT00706823|OG001|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
10929236|NCT00706823|EG000|Reported Event|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
10929237|NCT00706823|EG001|Reported Event|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
10929238|NCT00706836|BG000|Baseline|All 3 Treatments (Cross-Over Design)|"Pregabalin oral tablets (50 mg) Pregabalin oral tables (200 mg) Placebo~All subjects received all 3 treatments on different days.~Sequence data not available."
10929239|NCT00706836|FG000|Participant Flow|All Study Participants|"Pregabalin oral tablets (50 mg) Pregabalin oral tablets (200 mg) Placebo~All participants received all 3 treatments on different days.~Sequence not available."
10929240|NCT00706836|OG000|Outcome|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)~pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
10929241|NCT00706836|OG001|Outcome|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)~pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
10929242|NCT00706836|OG002|Outcome|Placebo (Crossover)|"Placebo~placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
10929243|NCT00706836|EG000|Reported Event|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)~pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
10929244|NCT00706836|EG001|Reported Event|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)~pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
10929245|NCT00706836|EG002|Reported Event|Placebo (Crossover)|"Placebo~placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
10929246|NCT00706849|BG000|Baseline|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
11377044|NCT00346164|BG004|Baseline|Total|Total of all reporting groups
10929247|NCT00706849|BG001|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10929248|NCT00706849|BG002|Baseline|Total|Total of all reporting groups
10929249|NCT00706849|FG000|Participant Flow|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
10929250|NCT00706849|FG001|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10929251|NCT00706849|OG000|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
10929252|NCT00706849|OG001|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10929253|NCT00706849|EG000|Reported Event|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
10929254|NCT00706849|EG001|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10929255|NCT00706901|BG000|Baseline|Arm 1 GMI|Group Motivational Interviewing
10929256|NCT00706901|BG001|Baseline|Arm 2 IHMD|In-Home-Messaging Device
10929257|NCT00706901|BG002|Baseline|Arm 3 TCC|Treatment Control condition
10929258|NCT00706901|BG003|Baseline|Total|Total of all reporting groups
10929259|NCT00706901|FG000|Participant Flow|Arm 1 GMI|Participants in GMI first completed a baseline assessment, then returned 1 week later to attend four GMI sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
10929260|NCT00706901|FG001|Participant Flow|Arm 2 IHMD|Participants in IHMD first completed a baseline assessment, then received within a 1 week period their IHMD CCHT device to be used on a daily basis for 27 days in their home. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
10929261|NCT00706901|FG002|Participant Flow|Arm 3 TCC|Participants in TCC first completed a baseline assessment, then returned 1 week later to attend four TCC sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
10929262|NCT00706901|OG000|Outcome|Arm 1 GMI|Group Motivational Interviewing
10929263|NCT00706901|OG001|Outcome|Arm 2 IHMD|In Home Messaging Device
10929264|NCT00706901|OG002|Outcome|Arm 3 TCC|Treatment Control Condition
10929265|NCT00706901|OG001|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
10929266|NCT00706901|EG000|Reported Event|Arm 1 GMI|Group Motivational Interviewing
10929267|NCT00706901|EG001|Reported Event|Arm 2 IHMD|In Home Messaging Device
10929268|NCT00706901|EG002|Reported Event|Arm 3 TCC|Treatment Control Condition
10929269|NCT00706914|BG000|Baseline|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
10929270|NCT00706914|BG001|Baseline|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
10929271|NCT00706914|BG002|Baseline|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
10929272|NCT00706914|BG003|Baseline|Total|Total of all reporting groups
10929273|NCT00706914|FG000|Participant Flow|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
10929274|NCT00706914|FG001|Participant Flow|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
10929275|NCT00706914|FG002|Participant Flow|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
10929276|NCT00706914|OG000|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
10929277|NCT00706914|OG001|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
10929278|NCT00706914|OG002|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
10929279|NCT00706914|EG000|Reported Event|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
10929280|NCT00706914|EG001|Reported Event|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
10929281|NCT00706914|EG002|Reported Event|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
10929282|NCT00706966|BG000|Baseline|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
10929283|NCT00706966|FG000|Participant Flow|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
10929284|NCT00706966|OG000|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
10929285|NCT00706966|OG000|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at Baseline.
10929286|NCT00706966|OG001|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
10929287|NCT00706966|OG002|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
10929288|NCT00706966|OG003|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
10929289|NCT00706966|OG000|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at baseline.
10929290|NCT00706966|OG001|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 1 month.
10929291|NCT00706966|OG002|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 3 months.
10929292|NCT00706966|OG003|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 6 months.
10929293|NCT00706966|OG000|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at Baseline.
10929294|NCT00706966|OG001|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 1 month.
10929295|NCT00706966|OG002|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 3 months.
10929296|NCT00706966|OG003|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 6 months.
10929297|NCT00706966|OG000|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at Baseline.
10929298|NCT00706966|OG001|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 1 month.
10929299|NCT00706966|OG002|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 3 months.
10929300|NCT00706966|OG003|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 6 months.
10929301|NCT00706966|OG000|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at Baseline.
10929302|NCT00706966|OG001|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 1 month.
10929303|NCT00706966|OG002|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 3 months.
10929304|NCT00706966|OG003|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 6 months.
10929305|NCT00706966|OG000|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at Baseline.
10929306|NCT00706966|OG001|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 1 month.
10929307|NCT00706966|OG002|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 3 months.
10929308|NCT00706966|OG003|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 6 months.
11240625|NCT02480920|OG000|Outcome|Study Popülation: Who Received NOAC for More Than 3 Months|In order to identify the independent predictive variables that could affect the medication adherence of the patients with logistic regression analysis, the patients were categorized into 2 groups as adherent patients who had high and medium adherence (Morisky score 6 or more) and nonadherent patients who had low adherence (Morisky score 5 or less).
10929309|NCT00706966|OG000|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at Baseline.
10929310|NCT00706966|OG001|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 1 month.
10929311|NCT00706966|OG002|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 3 months.
10929312|NCT00706966|OG003|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 6 months.
10929313|NCT00706966|EG000|Reported Event|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride: 6 months of dutasteride 3.5 mg daily"
10929314|NCT00706979|BG000|Baseline|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
10929315|NCT00706979|BG001|Baseline|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
10929316|NCT00706979|BG002|Baseline|Total|Total of all reporting groups
10929317|NCT00706979|FG000|Participant Flow|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
10929318|NCT00706979|FG001|Participant Flow|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
10929319|NCT00706979|OG000|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
10929320|NCT00706979|OG001|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
10929321|NCT00706979|EG000|Reported Event|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
10929322|NCT00706979|EG001|Reported Event|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
10929323|NCT00706992|BG000|Baseline|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
10929324|NCT00706992|BG001|Baseline|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
10929325|NCT00706992|BG002|Baseline|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
10929326|NCT00706992|BG003|Baseline|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
10929327|NCT00706992|BG004|Baseline|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
10929328|NCT00706992|BG005|Baseline|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
11240626|NCT02480920|EG000|Reported Event|Advers Events|The adverse effects, stroke, and any bleeding complication during NOAC treatment. Major bleeding was defined as a hemorrhage leading to a reduction in hemoglobin concentration of 2 g/dL, necessitating the transfusion of 2 or more units of blood, or symptomatic bleeding into a critical area or organ.
10929329|NCT00706992|BG006|Baseline|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
10929330|NCT00706992|BG007|Baseline|Total|Total of all reporting groups
10929331|NCT00706992|FG000|Participant Flow|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
10929332|NCT00706992|FG001|Participant Flow|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
10929333|NCT00706992|FG002|Participant Flow|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
10929334|NCT00706992|FG003|Participant Flow|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
10929335|NCT00706992|FG004|Participant Flow|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
10929336|NCT00706992|FG005|Participant Flow|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
10929337|NCT00706992|FG006|Participant Flow|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
10929338|NCT00706992|OG000|Outcome|Arm I - 6|Arm I - Adj-4 A2 F5 cells Arm II-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide Arm III-Adj-4 A2 F5 cells + SQ IL-2 Arm IV-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide+SQ IL-2 Arm V-Adj-4 A2 F5 cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 cells + ALVAC MART-1 Vaccine + SQ IL-2
10929339|NCT00706992|OG000|Outcome|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
10929340|NCT00706992|OG001|Outcome|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
10929341|NCT00706992|OG002|Outcome|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
10929342|NCT00706992|OG003|Outcome|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
10929343|NCT00706992|OG004|Outcome|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
10929344|NCT00706992|OG005|Outcome|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
10929345|NCT00706992|OG006|Outcome|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
10929346|NCT00706992|EG000|Reported Event|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
10929347|NCT00706992|EG001|Reported Event|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
10929348|NCT00706992|EG002|Reported Event|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
11240627|NCT02480998|BG000|Baseline|IL-YANG Flu Vaccine QIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine QIV 0.5mL"
11240628|NCT02480998|BG001|Baseline|IL-YANG Flu Vaccine TIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine TIV 0.5mL"
10929349|NCT00706992|EG003|Reported Event|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
11240629|NCT02480998|BG002|Baseline|Total|Total of all reporting groups
11240630|NCT02480998|FG000|Participant Flow|IL-YANG Flu Vaccine QIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine QIV 0.5mL"
11240631|NCT02480998|FG001|Participant Flow|IL-YANG Flu Vaccine TIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine TIV 0.5mL"
10929350|NCT00706992|EG004|Reported Event|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
10929351|NCT00706992|EG005|Reported Event|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
10929352|NCT00706992|EG006|Reported Event|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
10929353|NCT00707031|BG000|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10929354|NCT00707031|BG001|Baseline|Exenatide|1-step initiation regimen of exenatide: 5 mcg BID subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
10929355|NCT00707031|BG002|Baseline|Total|Total of all reporting groups
10929356|NCT00707031|FG000|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10929357|NCT00707031|FG001|Participant Flow|Exenatide|1-step initiation regimen of exenatide: 5 mcg twice daily (BID) subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
10929358|NCT00707031|OG000|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
10929359|NCT00707031|OG001|Outcome|Exenatide|1-step initiation regimen of exenatide.
10929360|NCT00707031|OG001|Outcome|Exenatide|2-step initiation regimen of exenatide.
10929361|NCT00707031|EG000|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
10929362|NCT00707031|EG001|Reported Event|Exenatide|1-step initiation regimen of exenatide.
10929363|NCT00707057|BG000|Baseline|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
10929364|NCT00707057|BG001|Baseline|Placebo|Participants received placebo tablet twice daily (BID)
10929365|NCT00707057|BG002|Baseline|Total|Total of all reporting groups
10929366|NCT00707057|FG000|Participant Flow|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
10929367|NCT00707057|FG001|Participant Flow|Placebo|Participants received placebo tablet twice daily (BID)
10929368|NCT00707057|OG000|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
10929369|NCT00707057|OG001|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
10929370|NCT00707057|EG000|Reported Event|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
10929371|NCT00707057|EG001|Reported Event|Placebo|Participants received placebo tablet twice daily (BID)
10929372|NCT00707174|BG000|Baseline|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
10929373|NCT00707174|BG001|Baseline|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
10929374|NCT00707174|BG002|Baseline|Total|Total of all reporting groups
10929375|NCT00707174|FG000|Participant Flow|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
10929376|NCT00707174|FG001|Participant Flow|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
10929377|NCT00707174|OG000|Outcome|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
10929378|NCT00707174|OG001|Outcome|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
10929379|NCT00707174|EG000|Reported Event|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
10929380|NCT00707174|EG001|Reported Event|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
10929381|NCT00707239|BG000|Baseline|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
10929382|NCT00707239|BG001|Baseline|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
10929383|NCT00707239|BG002|Baseline|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
10929384|NCT00707239|BG003|Baseline|Total|Total of all reporting groups
10929385|NCT00707239|FG000|Participant Flow|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
10929386|NCT00707239|FG001|Participant Flow|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
10929387|NCT00707239|FG002|Participant Flow|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
10929388|NCT00707239|OG000|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
10929389|NCT00707239|OG001|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
10929390|NCT00707239|OG002|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
10929391|NCT00707239|OG000|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
10929392|NCT00707239|OG000|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
10929393|NCT00707239|OG000|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously every 12 hrs at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
10929394|NCT00707239|EG000|Reported Event|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
10929395|NCT00707239|EG001|Reported Event|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
10929396|NCT00707239|EG002|Reported Event|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
10929397|NCT00707343|BG000|Baseline|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
10929398|NCT00707343|FG000|Participant Flow|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
10929399|NCT00707343|OG000|Outcome|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
10929400|NCT00707343|EG000|Reported Event|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
10929401|NCT00707447|BG000|Baseline|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
10929402|NCT00707447|BG001|Baseline|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
10929403|NCT00707447|BG002|Baseline|Total|Total of all reporting groups
10929404|NCT00707447|FG000|Participant Flow|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
10929405|NCT00707447|FG001|Participant Flow|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
10929406|NCT00707447|OG000|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
10929407|NCT00707447|OG001|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
10929408|NCT00707447|EG000|Reported Event|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
10929409|NCT00707447|EG001|Reported Event|2/PREDIAS|Intervention consists of a group programme (PRAEDIAS) aiming at modification of lifestyle
10929410|NCT00707486|BG000|Baseline|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
10929411|NCT00707486|FG000|Participant Flow|Hemcon Dental Dressing With Pressure|Subjects served as their own control. Subject had both the HemCon Dental Dressing and one of two controls: Gelfoam or Gauze with pressure. Subjects had paired extractions; each extraction site within the pair were randomized to the HemCon Dental Dressing or to a control.
10929412|NCT00707486|OG000|Outcome|HemCon|Experimental
10929413|NCT00707486|OG001|Outcome|Control: Gauze|
10929414|NCT00707486|OG002|Outcome|Total|
10929415|NCT00707486|EG000|Reported Event|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
10929416|NCT00707577|BG000|Baseline|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
10929417|NCT00707577|BG001|Baseline|Control|No maintenance program provided
10929418|NCT00707577|BG002|Baseline|Total|Total of all reporting groups
10929419|NCT00707577|FG000|Participant Flow|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
10929420|NCT00707577|FG001|Participant Flow|Control|No maintenance program provided
10929421|NCT00707577|OG000|Outcome|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
10929422|NCT00707577|OG001|Outcome|Control|No maintenance program provided
10963264|NCT00871169|OG000|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
10929423|NCT00707577|EG000|Reported Event|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
10929424|NCT00707577|EG001|Reported Event|Control|No maintenance program provided
10929425|NCT00707655|BG000|Baseline|Zalutumumab 4 mg/kg|8 weekly infusions
10929426|NCT00707655|BG001|Baseline|Zalutumumab 8 mg/kg|8 weekly infusions
10929427|NCT00707655|BG002|Baseline|Total|Total of all reporting groups
10929428|NCT00707655|FG000|Participant Flow|Zalutumumab 4 mg/kg|8 weekly infusions
10929429|NCT00707655|FG001|Participant Flow|Zalutumumab 8 mg/kg|8 weekly infusions
10929430|NCT00707655|OG000|Outcome|Zalutumumab 4 mg/kg|
10929431|NCT00707655|OG001|Outcome|Zalutumumab 8 mg/kg|
10929432|NCT00707655|OG000|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
10929433|NCT00707655|OG001|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
10929434|NCT00707655|EG000|Reported Event|Zalutumumab 4 mg/kg|8 weekly infusions
10929435|NCT00707655|EG001|Reported Event|Zalutumumab 8 mg/kg|8 weekly infusions
10929436|NCT00707746|BG000|Baseline|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
10929437|NCT00707746|BG001|Baseline|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
10929438|NCT00707746|BG002|Baseline|Total|Total of all reporting groups
10929439|NCT00707746|FG000|Participant Flow|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
10929440|NCT00707746|FG001|Participant Flow|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
10929441|NCT00707746|OG000|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
10929442|NCT00707746|OG001|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
10929443|NCT00707746|EG000|Reported Event|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
10929444|NCT00707746|EG001|Reported Event|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
10929445|NCT00707759|BG000|Baseline|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
10929446|NCT00707759|BG001|Baseline|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
10929447|NCT00707759|BG002|Baseline|Total|Total of all reporting groups
10929448|NCT00707759|FG000|Participant Flow|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
10929449|NCT00707759|FG001|Participant Flow|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
10929450|NCT00707759|OG000|Outcome|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
10929451|NCT00707759|OG001|Outcome|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
10929452|NCT00707759|EG000|Reported Event|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
10929453|NCT00707759|EG001|Reported Event|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
10929454|NCT00707863|BG000|Baseline|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
10929455|NCT00707863|BG001|Baseline|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
10929456|NCT00707863|BG002|Baseline|Total|Total of all reporting groups
10929457|NCT00707863|FG000|Participant Flow|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
10929458|NCT00707863|FG001|Participant Flow|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
10929459|NCT00707863|OG000|Outcome|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
10929460|NCT00707863|OG001|Outcome|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
10929461|NCT00707863|EG000|Reported Event|Subjects Age: 18 - 25|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
10929462|NCT00707863|EG001|Reported Event|Subjects Age: 26 - 50|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth per day for 8 weeks"
10929463|NCT00707915|BG000|Baseline|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
10929464|NCT00707915|FG000|Participant Flow|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
10929465|NCT00707915|OG000|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
10929466|NCT00707915|EG000|Reported Event|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
10929467|NCT00707954|BG000|Baseline|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929468|NCT00707954|BG001|Baseline|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929469|NCT00707954|BG002|Baseline|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929470|NCT00707954|BG003|Baseline|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929471|NCT00707954|BG004|Baseline|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929472|NCT00707954|BG005|Baseline|Total|Total of all reporting groups
10929473|NCT00707954|FG000|Participant Flow|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929474|NCT00707954|FG001|Participant Flow|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929475|NCT00707954|FG002|Participant Flow|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929476|NCT00707954|FG003|Participant Flow|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929477|NCT00707954|FG004|Participant Flow|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929478|NCT00707954|OG000|Outcome|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929479|NCT00707954|OG001|Outcome|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929480|NCT00707954|OG002|Outcome|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929481|NCT00707954|OG003|Outcome|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929482|NCT00707954|OG004|Outcome|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929483|NCT00707954|EG000|Reported Event|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929484|NCT00707954|EG001|Reported Event|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929485|NCT00707954|EG002|Reported Event|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929486|NCT00707954|EG003|Reported Event|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929487|NCT00707954|EG004|Reported Event|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
10929488|NCT00707967|BG000|Baseline|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929489|NCT00707967|BG001|Baseline|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929490|NCT00707967|BG002|Baseline|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929491|NCT00707967|BG003|Baseline|Total|Total of all reporting groups
10929492|NCT00707967|FG000|Participant Flow|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929493|NCT00707967|FG001|Participant Flow|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929494|NCT00707967|FG002|Participant Flow|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929495|NCT00707967|OG000|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929496|NCT00707967|OG001|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929497|NCT00707967|OG002|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929498|NCT00707967|EG000|Reported Event|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929499|NCT00707967|EG001|Reported Event|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929500|NCT00707967|EG002|Reported Event|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
10929501|NCT00707980|BG000|Baseline|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
10929502|NCT00707980|FG000|Participant Flow|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
10929503|NCT00707980|OG000|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
10929504|NCT00707980|EG000|Reported Event|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
10929505|NCT00707993|BG000|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
10929506|NCT00707993|BG001|Baseline|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
10929507|NCT00707993|BG002|Baseline|Total|Total of all reporting groups
10929508|NCT00707993|FG000|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
10929509|NCT00707993|FG001|Participant Flow|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
10929510|NCT00707993|OG000|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
10929511|NCT00707993|OG001|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
10929512|NCT00707993|EG000|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
11240632|NCT02480998|OG000|Outcome|IL-YANG Flu Vaccine QIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine QIV 0.5mL"
10929513|NCT00707993|EG001|Reported Event|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
10929514|NCT00708019|BG000|Baseline|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
10929515|NCT00708019|BG001|Baseline|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
10929516|NCT00708019|BG002|Baseline|Total|Total of all reporting groups
10929517|NCT00708019|FG000|Participant Flow|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
10929518|NCT00708019|FG001|Participant Flow|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
10929519|NCT00708019|OG000|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
10929520|NCT00708019|OG001|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
10929521|NCT00708019|EG000|Reported Event|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
11240633|NCT02480998|OG001|Outcome|IL-YANG Flu Vaccine TIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine TIV 0.5mL"
11240634|NCT02480998|OG000|Outcome|IL-YANG Flu Vaccine QIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine QIV 0.5mL~56"
11240635|NCT02480998|OG001|Outcome|IL-YANG Flu Vaccine TIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine TIV 0.5mL~28"
10929522|NCT00708019|EG001|Reported Event|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
10929523|NCT00708032|BG000|Baseline|Spectacles|spectacles worn daily for 12 months
10929524|NCT00708032|BG001|Baseline|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
10929525|NCT00708032|BG002|Baseline|Total|Total of all reporting groups
10929526|NCT00708032|FG000|Participant Flow|Spectacles|spectacles worn daily for 12 months
10929527|NCT00708032|FG001|Participant Flow|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
10929528|NCT00708032|OG000|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
10929529|NCT00708032|OG001|Outcome|Spectacles|habitual spectacles worn daily for 12 months
10929530|NCT00708032|EG000|Reported Event|Spectacles|spectacles worn daily for 12 months
10929531|NCT00708032|EG001|Reported Event|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
10929532|NCT00708071|BG000|Baseline|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
10929533|NCT00708071|FG000|Participant Flow|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
10929534|NCT00708071|OG000|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
10929535|NCT00708071|OG001|Outcome|Participants With Less Ecchymosis Treated With SoC|
10929536|NCT00708071|OG002|Outcome|Participants With Equal Ecchymosis On Both Sides|
10929537|NCT00708071|OG003|Outcome|Participants With No Ecchymosis on Either Side|
10929538|NCT00708071|OG000|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
11240636|NCT02480998|EG000|Reported Event|IL-YANG Flu Vaccine QIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine QIV 0.5mL"
10929539|NCT00708071|OG000|Outcome|Complete Resolution of Ecchymosis With FS VH S/D 4 But Not SoC|
10929540|NCT00708071|OG001|Outcome|Complete Resolution of Ecchymosis With SoC But Not FS VH S/D 4|
10929541|NCT00708071|OG002|Outcome|Participants With Complete Resolution on Both Sides|
10929542|NCT00708071|OG003|Outcome|Participants With No Resolution on Either Side|
10929543|NCT00708071|OG000|Outcome|Complete Resolution of Edema With FS VH S/D 4 But Not SoC|
10929544|NCT00708071|OG001|Outcome|Complete Resolution of Edema With SoC But Not FS VH S/D 4|
10929545|NCT00708071|OG000|Outcome|Standard of Care (SoC)|
10929546|NCT00708071|OG001|Outcome|FS VH S/D 4|
10929547|NCT00708071|OG000|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 Side|
10929548|NCT00708071|OG001|Outcome|Participants With Hematoma/Seroma on SoC Side|
10929549|NCT00708071|OG002|Outcome|Participants With Hematoma/Seroma on Both Sides|
10929550|NCT00708071|OG003|Outcome|Participants With No Hematoma/Seroma on Either Side|
10929551|NCT00708071|OG000|Outcome|FS VH S/D 4 - Day3|
10929552|NCT00708071|OG001|Outcome|SoC - Day 3|
10929553|NCT00708071|OG002|Outcome|FS VH S/D 4 - Day 7|
10929554|NCT00708071|OG003|Outcome|SoC - Day 7|
10929555|NCT00708071|OG004|Outcome|FS VH S/D 4 - Day 10|
10929556|NCT00708071|OG005|Outcome|SoC - Day 10|
10929557|NCT00708071|OG006|Outcome|FS VH S/D 4 - Day 14|
10929558|NCT00708071|OG007|Outcome|SoC - Day 14|
10929559|NCT00708071|OG000|Outcome|Facelift Participants|
10929560|NCT00708071|OG000|Outcome|No Difference|
10929561|NCT00708071|OG001|Outcome|FS VH S/D 4 Looks Better|
10929562|NCT00708071|OG002|Outcome|SoC Looks Better|
10929563|NCT00708071|EG000|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care.
10929564|NCT00708071|EG001|Reported Event|Localized to FS VH S/D 4 Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4.
10929565|NCT00708071|EG002|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
10929566|NCT00708097|BG000|Baseline|All Randomized Participants|All randomized participants who received at least one of the treatment dentifrices during the study and had at least one safety assessment after using the treatment dentifrice.
10929567|NCT00708097|FG000|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929568|NCT00708097|FG001|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
11240637|NCT02480998|EG001|Reported Event|IL-YANG Flu Vaccine TIV 0.5mL|"A single 0.5mL dose administrated as an intramuscular injection.~IL-YANG Flu Vaccine TIV 0.5mL"
11377045|NCT00346164|FG000|Participant Flow|Arm A: No Adjuvant Treatment|"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery"
10929569|NCT00708097|FG002|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929570|NCT00708097|FG003|Participant Flow|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929571|NCT00708097|FG004|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929572|NCT00708097|OG000|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929573|NCT00708097|OG001|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929574|NCT00708097|OG000|Outcome|NaF/Carbopol Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929575|NCT00708097|OG001|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929576|NCT00708097|OG002|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929577|NCT00708097|OG003|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929578|NCT00708097|OG004|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929579|NCT00708097|OG000|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929580|NCT00708097|OG002|Outcome|NaMFP/ NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929581|NCT00708097|EG000|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929582|NCT00708097|EG001|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929583|NCT00708097|EG002|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929584|NCT00708097|EG003|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929585|NCT00708097|EG004|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
10929586|NCT00708097|EG005|Reported Event|Overall|All participants received all treatments during the study
10929587|NCT00708110|BG000|Baseline|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
10929588|NCT00708110|BG001|Baseline|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
10929589|NCT00708110|BG002|Baseline|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
10929590|NCT00708110|BG003|Baseline|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
10929591|NCT00708110|BG004|Baseline|Total|Total of all reporting groups
10929592|NCT00708110|FG000|Participant Flow|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
10929593|NCT00708110|FG001|Participant Flow|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
10929594|NCT00708110|FG002|Participant Flow|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
10929595|NCT00708110|FG003|Participant Flow|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
10929596|NCT00708110|OG000|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
10929597|NCT00708110|OG001|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
10929598|NCT00708110|OG002|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
10929599|NCT00708110|OG003|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
10929600|NCT00708110|EG000|Reported Event|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
10929601|NCT00708110|EG001|Reported Event|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
10929602|NCT00708110|EG002|Reported Event|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
10929603|NCT00708110|EG003|Reported Event|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
10929604|NCT00708123|BG000|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
10929605|NCT00708123|FG000|Participant Flow|Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929606|NCT00708123|FG001|Participant Flow|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929607|NCT00708123|FG002|Participant Flow|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929608|NCT00708123|FG003|Participant Flow|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929609|NCT00708123|FG004|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
10929610|NCT00708123|OG000|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929611|NCT00708123|OG001|Outcome|NaF Toothpaste (1350 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929612|NCT00708123|OG002|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
10929613|NCT00708123|OG000|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929614|NCT00708123|OG001|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929615|NCT00708123|OG002|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929616|NCT00708123|OG003|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929617|NCT00708123|OG004|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
10929618|NCT00708123|OG000|Outcome|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929619|NCT00708123|EG000|Reported Event|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929620|NCT00708123|EG001|Reported Event|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929621|NCT00708123|EG002|Reported Event|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929622|NCT00708123|EG003|Reported Event|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
10929623|NCT00708123|EG004|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
10929624|NCT00708162|BG000|Baseline|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
10929625|NCT00708162|BG001|Baseline|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
10929626|NCT00708162|BG002|Baseline|Total|Total of all reporting groups
10929627|NCT00708162|FG000|Participant Flow|Elvitegravir|Elvitegravir (EVG) 85 or 150 mg tablet once daily plus raltegravir (RAL) placebo plus background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
10929628|NCT00708162|FG001|Participant Flow|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
10929629|NCT00708162|OG000|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
10929630|NCT00708162|OG001|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
10929631|NCT00708162|EG000|Reported Event|Elvitegravir|"Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during the Randomized Phase~EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
10929632|NCT00708162|EG001|Reported Event|Raltegravir|"Adverse events in this reporting group are those experienced by participants in the Raltegravir group during the Randomized Phase~RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
10929633|NCT00708162|EG002|Reported Event|All Elvitegravir|Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during both the Randomized Phase and Open-Label Phase, and those experienced by participants in the Raltegravir group following switch to EVG in the Open-Label Phase only.
10929634|NCT00708175|BG000|Baseline|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
10929635|NCT00708175|BG001|Baseline|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
10929636|NCT00708175|BG002|Baseline|Total|Total of all reporting groups
10929637|NCT00708175|FG000|Participant Flow|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
10929638|NCT00708175|FG001|Participant Flow|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
10929639|NCT00708175|OG000|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
10929640|NCT00708175|OG001|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
10929641|NCT00708175|EG000|Reported Event|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
10929642|NCT00708175|EG001|Reported Event|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
10929643|NCT00708201|BG000|Baseline|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
10929644|NCT00708201|BG001|Baseline|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
10929645|NCT00708201|BG002|Baseline|Total|Total of all reporting groups
10929646|NCT00708201|FG000|Participant Flow|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
10929647|NCT00708201|FG001|Participant Flow|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
10929648|NCT00708201|OG000|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
10929649|NCT00708201|OG001|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
10929650|NCT00708201|EG000|Reported Event|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
10929651|NCT00708201|EG001|Reported Event|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
10929652|NCT00708214|BG000|Baseline|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929653|NCT00708214|BG001|Baseline|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929654|NCT00708214|BG002|Baseline|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929655|NCT00708214|BG003|Baseline|Total|Total of all reporting groups
10929656|NCT00708214|FG000|Participant Flow|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929657|NCT00708214|FG001|Participant Flow|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929658|NCT00708214|FG002|Participant Flow|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929659|NCT00708214|OG000|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929660|NCT00708214|OG001|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929661|NCT00708214|OG002|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929662|NCT00708214|OG000|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929663|NCT00708214|OG001|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929664|NCT00708214|OG000|Outcome|Afatinib Overall, With Letrozole 2.5 mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929665|NCT00708214|OG000|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929666|NCT00708214|OG000|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929667|NCT00708214|EG000|Reported Event|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929668|NCT00708214|EG001|Reported Event|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929669|NCT00708214|EG002|Reported Event|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
10929670|NCT00708227|BG000|Baseline|Whites ADRB2:ARG16ARG|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~fluticasone: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
10929671|NCT00708227|BG001|Baseline|Whites ADRB2:GLY16GLY|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~Salmeterol: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
10929672|NCT00708227|BG002|Baseline|African Americans ADRB2:ARG16ARG|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~fluticasone: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
10929673|NCT00708227|BG003|Baseline|African Americans ADRB2:GLY16GLY|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~fluticasone: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
10929674|NCT00708227|BG004|Baseline|Total|Total of all reporting groups
10929675|NCT00708227|FG000|Participant Flow|Whites ADRB2:ARG16ARG|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~fluticasone: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
10929676|NCT00708227|FG001|Participant Flow|Whites ADRb2:GLY16GLY|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~Salmeterol: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
10929677|NCT00708227|FG002|Participant Flow|African Americans ADRB2:ARG16ARG|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~Salmeterol: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
10929678|NCT00708227|FG003|Participant Flow|African Americans ADRB2:GLY16GlY|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~Salmeterol: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
10929679|NCT00708227|OG000|Outcome|Whites ADRB2:ARG16ARG|Log10 methacholine PC20 data in Whites with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent.
10929680|NCT00708227|OG001|Outcome|Whites ADRB2:Gly16Gly|Log10 methacholine PC20 data in Whites with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent.
10929681|NCT00708227|OG002|Outcome|African Americans ADRB2:ARG16ARG|Log10 methacholine PC20 data in African Americans with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent.
10929682|NCT00708227|OG003|Outcome|African Americans ADRB2:GLY16GLY|Log10 methacholine PC20 data in African Americans with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent.
10929683|NCT00708227|OG000|Outcome|Whites ADRB2:ARG16ARG|Visit 3 log10 methacholine PC20 data in Whites with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Advair.
10929684|NCT00708227|OG001|Outcome|Whites ADRB2:Gly16Gly|Visit 3 log10 methacholine PC20 data in Whites with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Advair.
10929685|NCT00708227|OG002|Outcome|African Americans ADRB2:ARG16ARG|Visit 3 log10 methacholine PC20 data in African Americans with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Advair.
10929686|NCT00708227|OG003|Outcome|African Americans ADRB2:GLY16GLY|Visit 3 log10 methacholine PC20 data in African Americans with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Advair.
10929687|NCT00708227|OG000|Outcome|Whites ADRB2:ARG16ARG|Visit 4 log10 methacholine PC20 data in Whites with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent.
10929688|NCT00708227|OG001|Outcome|Whites ADRB2:Gly16Gly|Visit 4 log10 methacholine PC20 data in Whites with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent.
10929689|NCT00708227|OG002|Outcome|African Americans ADRB2:ARG16ARG|Visit 4 log10 methacholine PC20 data in African Americans with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent.
10929690|NCT00708227|OG003|Outcome|African Americans ADRB2:GLY16GLY|Visit 4 log10 methacholine PC20 data in African Americans with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent.
10929691|NCT00708227|OG000|Outcome|Whites ADRB2:ARG16ARG|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Flovent for 2 weeks at Visit 2.
10929692|NCT00708227|OG001|Outcome|Whites ADRB2:Gly16Gly|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Flovent for 2 weeks at Visit 2.
10929693|NCT00708227|OG002|Outcome|African Americans ADRB2:ARG16ARG|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Flovent for 2 weeks at Visit 2.
10929694|NCT00708227|OG003|Outcome|African Americans ADRB2:GLY16GLY|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Flovent for 2 weeks at Visit 2.
10929695|NCT00708227|OG000|Outcome|Whites ADRB2:ARG16ARG|All participants who had received Advair for 2 weeks at Visit 3.
10929696|NCT00708227|OG001|Outcome|Whites ADRB2:GLY16GLY|All participants who had received Advair for 2 weeks at Visit 3.
10929697|NCT00708227|OG002|Outcome|African Americans ADRB2:ARG16ARG|All participants who had received Advair for 2 weeks at Visit 3.
10929698|NCT00708227|OG003|Outcome|African Americans ADRB2:GLY16GLY|All participants who had received Advair for 2 weeks at Visit 3.
10929699|NCT00708227|OG000|Outcome|Whites ADRB2:ARG16ARG|Participants had discontinued Advair for 36 hours.
10929700|NCT00708227|OG001|Outcome|Whites ADRB2:GLY16GLY|Participants had discontinued Advair for 36 hours.
10929701|NCT00708227|OG002|Outcome|African Americans ADRB2:ARG16ARG|Participants had discontinued Advair for 36 hours.
10929702|NCT00708227|OG003|Outcome|African Americans ADRB2:GLY16GLY|Participants had discontinued Advair for 36 hours.
10929703|NCT00708227|EG000|Reported Event|Whites ADRB2:ARG16ARG|All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
10929704|NCT00708227|EG001|Reported Event|Whites ADRB2:GLY16GLY|All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
10929705|NCT00708227|EG002|Reported Event|African American ADRB2:ARG16ARG|All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
10929706|NCT00708227|EG003|Reported Event|African American ADRB2:GLY16GLY|All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
10963265|NCT00871169|EG000|Reported Event|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
10963266|NCT00871234|BG000|Baseline|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
10963267|NCT00871234|FG000|Participant Flow|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
10963268|NCT00871234|OG000|Outcome|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
10963269|NCT00871234|EG000|Reported Event|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
10963270|NCT00871260|BG000|Baseline|Healthy Patients|Due to low enrollment, twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery. All analyzes were based upon current enrollment.
10963271|NCT00871260|FG000|Participant Flow|Healthy Patients|Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
10963272|NCT00871260|OG000|Outcome|Healthy Patients|Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
10963273|NCT00871260|EG000|Reported Event|Healthy Patients|Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
10963274|NCT00871286|BG000|Baseline|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
10963275|NCT00871286|BG001|Baseline|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
10963276|NCT00871286|BG002|Baseline|Total|Total of all reporting groups
10963277|NCT00871286|FG000|Participant Flow|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
10963278|NCT00871286|FG001|Participant Flow|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
10963279|NCT00871286|OG000|Outcome|CT Scan (Sinus) Pre-tx|
10963280|NCT00871286|OG001|Outcome|CT Scan (Sinus) Post-tx|
10963281|NCT00871286|EG000|Reported Event|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
10963282|NCT00871286|EG001|Reported Event|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
10964070|NCT00875667|BG001|Baseline|Investigators Choice|Participants received a single agent investigators choice (IC) of chlorambucil 40 mg/m^2 PO every 28 days until progressive disease (PD) or toxicity, OR rituximab 375 mg/m^2 by intravenous (IV) infusion on days 1, 8, 15 and 22 of each 56-day treatment cycle until PD or toxicity, OR cytarabine 1-2 g/m^2 by IV infusion on days 1 and 2 of each 28 day treatment cycle; up to 6 cycles, OR gemcitabine 1000 mg/m^2 by IV infusion on days 1, 8 and 15 of each 28 day treatment cycle; up to 6 cycles OR oral fludarabine 40 mg/m^2 or IV fludarabine 25 mg/m^2 on days 1 through 5 of each 28-day cycle; up to 6 cycles. Participants were given the option to enter into the lenalidomide crossover phase if PD occurred and received lenalidomide 25 mg capsules daily on days 1 to 21 of each 28 day treatment cycle until PD or toxicity.
10964071|NCT00875667|BG002|Baseline|Total|Total of all reporting groups
10929707|NCT00708305|BG000|Baseline|Overall Study|All randomized participants
10929708|NCT00708305|FG000|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929709|NCT00708305|FG001|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929710|NCT00708305|FG002|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929711|NCT00708305|FG003|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929712|NCT00708305|OG000|Outcome|NaF Toothpaste(1450 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929713|NCT00708305|OG001|Outcome|NaF Toothpaste (1400 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929714|NCT00708305|OG000|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929715|NCT00708305|OG001|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929716|NCT00708305|OG002|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929717|NCT00708305|OG003|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929718|NCT00708305|OG000|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds
10929719|NCT00708305|EG000|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929720|NCT00708305|EG001|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929721|NCT00708305|EG002|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929722|NCT00708305|EG003|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
10929723|NCT00708422|BG000|Baseline|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
10929724|NCT00708422|BG001|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
10929725|NCT00708422|BG002|Baseline|Total|Total of all reporting groups
10929726|NCT00708422|FG000|Participant Flow|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
10929727|NCT00708422|FG001|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
10929728|NCT00708422|OG000|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
10929729|NCT00708422|OG001|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
10929730|NCT00708422|EG000|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
10929731|NCT00708422|EG001|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
10929732|NCT00708435|BG000|Baseline|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
10929733|NCT00708435|BG001|Baseline|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
10929734|NCT00708435|BG002|Baseline|Total|Total of all reporting groups
10929735|NCT00708435|FG000|Participant Flow|Beriplex® P/N|Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.
10929736|NCT00708435|FG001|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.
10929737|NCT00708435|OG000|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
10929738|NCT00708435|OG001|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
10929739|NCT00708435|OG000|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
10929740|NCT00708435|OG001|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
10929741|NCT00708435|EG000|Reported Event|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
10929742|NCT00708435|EG001|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
10929743|NCT00708461|BG000|Baseline|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
10929744|NCT00708461|BG001|Baseline|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
10929745|NCT00708461|BG002|Baseline|Total|Total of all reporting groups
10929746|NCT00708461|FG000|Participant Flow|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
10929747|NCT00708461|FG001|Participant Flow|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
10929748|NCT00708461|OG000|Outcome|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
10929749|NCT00708461|OG001|Outcome|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
10929750|NCT00708461|EG000|Reported Event|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
10929751|NCT00708461|EG001|Reported Event|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
10929752|NCT00708500|BG000|Baseline|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10929753|NCT00708500|BG001|Baseline|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
10929754|NCT00708500|BG002|Baseline|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10929755|NCT00708500|BG003|Baseline|Total|Total of all reporting groups
10929756|NCT00708500|FG000|Participant Flow|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10929757|NCT00708500|FG001|Participant Flow|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
10929758|NCT00708500|FG002|Participant Flow|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10929759|NCT00708500|OG000|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10929760|NCT00708500|OG001|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
10929761|NCT00708500|OG002|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10929762|NCT00708500|EG000|Reported Event|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10929763|NCT00708500|EG001|Reported Event|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
10929764|NCT00708500|EG002|Reported Event|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
10929765|NCT00708526|BG000|Baseline|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
10929766|NCT00708526|BG001|Baseline|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
10929767|NCT00708526|BG002|Baseline|Total|Total of all reporting groups
10929768|NCT00708526|FG000|Participant Flow|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
10929769|NCT00708526|FG001|Participant Flow|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
10929770|NCT00708526|OG000|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
10929771|NCT00708526|OG001|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
10929772|NCT00708526|EG000|Reported Event|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
10929773|NCT00708526|EG001|Reported Event|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
10929774|NCT00708552|BG000|Baseline|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
10929775|NCT00708552|BG001|Baseline|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929776|NCT00708552|BG002|Baseline|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929777|NCT00708552|BG003|Baseline|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
10929778|NCT00708552|BG004|Baseline|Total|Total of all reporting groups
10929779|NCT00708552|FG000|Participant Flow|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
10929780|NCT00708552|FG001|Participant Flow|SB-742457-15mg|Participants received one tablet of SB-742457-15 milligrams (mg) and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929781|NCT00708552|FG002|Participant Flow|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929782|NCT00708552|FG003|Participant Flow|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
10929783|NCT00708552|OG000|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
10929784|NCT00708552|OG001|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929785|NCT00708552|OG002|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929786|NCT00708552|OG003|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
10929787|NCT00708552|OG000|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929788|NCT00708552|OG001|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929789|NCT00708552|OG000|Outcome|Donepezil 5 mg|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
10929790|NCT00708552|OG001|Outcome|Donepezil 10 mg|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
10929791|NCT00708552|EG000|Reported Event|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
10929792|NCT00708552|EG001|Reported Event|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929793|NCT00708552|EG002|Reported Event|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
10929794|NCT00708552|EG003|Reported Event|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
10929795|NCT00708643|BG000|Baseline|Habitual Silicone Hydrogel|Habitual contact lens wear.
10929796|NCT00708643|BG001|Baseline|Narafilcon A|Silicone hydrogel daily disposable contact lens
10929797|NCT00708643|BG002|Baseline|Total|Total of all reporting groups
10929798|NCT00708643|FG000|Participant Flow|Habitual Silicone Hydrogel|Habitual contact lens wear.
10929799|NCT00708643|FG001|Participant Flow|Narafilcon A|Silicone hydrogel daily disposable contact lens
11240638|NCT02481050|BG000|Baseline|Eribulin Mesylate 1.4 mg/m^2|Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
10929800|NCT00708643|OG000|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
10929801|NCT00708643|OG001|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
10929802|NCT00708643|EG000|Reported Event|Habitual Silicone Hydrogel|Habitual contact lens wear.
10929803|NCT00708643|EG001|Reported Event|Narafilcon A|Silicone hydrogel daily disposable contact lens
10929804|NCT00708682|BG000|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
10929805|NCT00708682|FG000|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
10929806|NCT00708682|OG000|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
10929807|NCT00708682|EG000|Reported Event|Infant Series 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).~Other Adverse Events (AEs) (non-serious events): the number affected (n) for non-systematic (non-solicited) Other Adverse Events n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively."
10929808|NCT00708682|EG001|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
10929809|NCT00708682|EG002|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96."
10929810|NCT00708708|BG000|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
10929811|NCT00708708|FG000|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
10963283|NCT00871338|BG000|Baseline|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh.
10929812|NCT00708708|OG000|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
10929813|NCT00708708|OG000|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
10929814|NCT00708708|OG001|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
10929815|NCT00708708|OG002|Outcome|Remaining Participants|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
10929816|NCT00708708|EG000|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
10929817|NCT00708721|BG000|Baseline|All Groups|
10929818|NCT00708721|FG000|Participant Flow|Cohort 1: 5 mg/Day for 10 Days|5 mg/day for 10 out of 28 days
10929819|NCT00708721|FG001|Participant Flow|Cohort 2: 1 mg/Day for 10 Days|1 mg/day for 10/28 days and for cycle 1 and then 1 mg/day for 7/28 days for cycle 2 onward
10929820|NCT00708721|FG002|Participant Flow|Cohort 3: 1 mg/Day for 7 Days|1 mg/day for 7/28 days
10929821|NCT00708721|FG003|Participant Flow|Not Evaluable|
10929822|NCT00708721|OG000|Outcome|Cohort 1: 10 mg/Day for 10 Days|
10929823|NCT00708721|OG001|Outcome|Cohort 2: 1 mg/Day for 10 Days|
10929824|NCT00708721|OG002|Outcome|Cohort 3: 1 mg/Day for 7 Days|
10929825|NCT00708721|OG003|Outcome|Not Evaluable|
10929826|NCT00708721|OG000|Outcome|All Evaluable Patients|"All participants enrolled.~Clofarabine: Clofarabine is a rationally designed, second generation purine nucleoside analogue. Clofarabine was designed as a hybrid molecule to overcome the limitations and incorporate the best qualities of both fludarabine (F-ara-A) and cladribine (2-CdA, CdA) both of which are currently approved by various regulatory authorities for treatment of hematologic malignancies."
10929827|NCT00708721|OG000|Outcome|All Evaluable Patients|Only nine of the eleven patients were evaluable for this outcome measure.
10929828|NCT00708721|OG000|Outcome|All Evaluable Patients|All evaluable patients. Eleven patients were enrolled, but only nine were evaluable.
10929829|NCT00708721|OG000|Outcome|All Patients|All participants enrolled.
10929830|NCT00708721|EG000|Reported Event|All Groups|All patients who received study treatment.
10929831|NCT00708851|BG000|Baseline|NB-UVB Alone|"One leg receives NB-UVB Alone: NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week~Opposite leg receives: LCD therapy 2 applications/day and NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy 3 light exposures / week"
10929832|NCT00708851|FG000|Participant Flow|NB-UVB and NB-UVB+LCD|"NB-UVB Alone: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week~NB-UVB+LCD: 2 applications of LCD/day + NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy 3 light exposures / week"
10929833|NCT00708851|OG000|Outcome|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
10929834|NCT00708851|OG001|Outcome|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
10929835|NCT00708851|EG000|Reported Event|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
10929836|NCT00708851|EG001|Reported Event|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
10929837|NCT00708877|BG000|Baseline|Transplant|All patients enrolled in study.
10929838|NCT00708877|FG000|Participant Flow|Transplant|All patients enrolled in study.
10929839|NCT00708877|OG000|Outcome|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
10929840|NCT00708877|EG000|Reported Event|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
10929841|NCT00708942|BG000|Baseline|Arm 1: HAL Suppository, Laser Illumination|
10929842|NCT00708942|BG001|Baseline|Arm 2: Placebo Suppository, Laser Illumination|
10929843|NCT00708942|BG002|Baseline|Arm 3: No Intervention|
10929844|NCT00708942|BG003|Baseline|Arm 4: HAL Ointment, LED Diode Illumination|
10929845|NCT00708942|BG004|Baseline|Arm 5: Placebo Ointment, no Illumination|
10929846|NCT00708942|BG005|Baseline|Total|Total of all reporting groups
10929847|NCT00708942|FG000|Participant Flow|Arm 1: HAL Suppository, Laser Illumination|
10929848|NCT00708942|FG001|Participant Flow|Arm 2: Placebo Suppository, Laser Illumination|
10929849|NCT00708942|FG002|Participant Flow|Arm 3: No Intervention|
10929850|NCT00708942|FG003|Participant Flow|Arm 4: HAL Ointment, LED Diode Illumination|
10929851|NCT00708942|FG004|Participant Flow|Arm 5: Placebo Ointment, no Illumination|
10929852|NCT00708942|OG000|Outcome|Arm 1: HAL Suppository, Laser Illumination|
10929853|NCT00708942|OG001|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
10929854|NCT00708942|OG002|Outcome|Arm 3: No Intervention|
10929855|NCT00708942|OG003|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
10929856|NCT00708942|OG004|Outcome|Arm 5: Placebo Ointment, no Illumination|
10929857|NCT00708942|EG000|Reported Event|Arm 1: HAL Suppository, Laser Illumination|
10929858|NCT00708942|EG001|Reported Event|Arm 2: Placebo Suppository, Laser Illumination|
10929859|NCT00708942|EG002|Reported Event|Arm 3: No Intervention|
10929860|NCT00708942|EG003|Reported Event|Arm 4: HAL Ointment, LED Diode Illumination|
10929861|NCT00708942|EG004|Reported Event|Arm 5: Placebo Ointment, no Illumination|
10929862|NCT00709059|BG000|Baseline|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
10929863|NCT00709059|FG000|Participant Flow|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
10929864|NCT00709059|OG000|Outcome|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
10929865|NCT00709059|EG000|Reported Event|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
10929866|NCT00709098|BG000|Baseline|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
10929867|NCT00709098|BG001|Baseline|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
10929868|NCT00709098|BG002|Baseline|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
10929869|NCT00709098|BG003|Baseline|Total|Total of all reporting groups
10929870|NCT00709098|FG000|Participant Flow|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
10929871|NCT00709098|FG001|Participant Flow|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
10929872|NCT00709098|FG002|Participant Flow|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
10929873|NCT00709098|OG000|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
10929874|NCT00709098|OG001|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
10929875|NCT00709098|OG002|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
10929876|NCT00709098|OG000|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 6 disc
10929877|NCT00709098|EG000|Reported Event|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
10929878|NCT00709098|EG001|Reported Event|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
10929879|NCT00709098|EG002|Reported Event|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
10929880|NCT00709111|BG000|Baseline|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
10929881|NCT00709111|FG000|Participant Flow|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
10929882|NCT00709111|OG000|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
10929883|NCT00709111|EG000|Reported Event|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
10929884|NCT00709124|BG000|Baseline|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
10929885|NCT00709124|BG001|Baseline|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
10929886|NCT00709124|BG002|Baseline|Total|Total of all reporting groups
10929887|NCT00709124|FG000|Participant Flow|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
10929888|NCT00709124|FG001|Participant Flow|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
10929889|NCT00709124|OG000|Outcome|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
10929890|NCT00709124|OG001|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
10929891|NCT00709124|OG000|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
10929892|NCT00709124|OG001|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
10929893|NCT00709124|OG000|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
10929894|NCT00709124|OG001|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
10929895|NCT00709124|EG000|Reported Event|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
10929896|NCT00709124|EG001|Reported Event|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
10929897|NCT00709202|BG000|Baseline|Betahistine|"Subjects assigned to this arm will receive Betahistine.~Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID."
10929898|NCT00709202|BG001|Baseline|Placebo|"Subjects in this group will received placebo.~Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID."
10929899|NCT00709202|BG002|Baseline|Total|Total of all reporting groups
10929900|NCT00709202|FG000|Participant Flow|Betahistine|"Subjects assigned to this arm will receive Betahistine.~Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID."
10929901|NCT00709202|FG001|Participant Flow|Placebo|"Subjects in this group will received placebo.~Placebo: Subjects will be receive placebo tablets matched in number to betahistine tablets"
10929902|NCT00709202|OG000|Outcome|Betahistine|"Subjects assigned to this arm will receive Betahistine.~Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID."
10929903|NCT00709202|OG001|Outcome|Placebo|"Subjects in this group will received placebo.~Placebo Oral Tablet"
10929904|NCT00709202|OG001|Outcome|Placebo|"Subjects in this group will received placebo.~Placebo: Subjects will be receive placebo tablets matched in number to betahistine tablets"
10929905|NCT00709202|EG000|Reported Event|Betahistine|"Subjects assigned to this arm will receive Betahistine.~Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID."
10929906|NCT00709202|EG001|Reported Event|Placebo|"Subjects in this group will received placebo.~Placebo Oral Tablet"
10929907|NCT00709228|BG000|Baseline|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative HCV-RNA at Week 4 and at Week 24 (n = 170)
10929908|NCT00709228|FG000|Participant Flow|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
10929909|NCT00709228|OG000|Outcome|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
10929910|NCT00709228|EG000|Reported Event|PegInton Plus Rebetol|
10929911|NCT00709306|BG000|Baseline|Educational Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
10929912|NCT00709306|BG001|Baseline|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
10929913|NCT00709306|BG002|Baseline|UV-detect Photos|"Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage. Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average."
10929914|NCT00709306|BG003|Baseline|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
10929915|NCT00709306|BG004|Baseline|Total|Total of all reporting groups
10929916|NCT00709306|FG000|Participant Flow|Education Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
10929917|NCT00709306|FG001|Participant Flow|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
10929918|NCT00709306|FG002|Participant Flow|UV-detect Photos|"Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage. Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average."
10929919|NCT00709306|FG003|Participant Flow|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
10929920|NCT00709306|OG000|Outcome|Education Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
10929921|NCT00709306|OG001|Outcome|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
10929922|NCT00709306|OG002|Outcome|UV-detect Photos|"Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage. Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average."
10929923|NCT00709306|OG003|Outcome|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
10929924|NCT00709306|EG000|Reported Event|Education Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
10929925|NCT00709306|EG001|Reported Event|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
10929926|NCT00709306|EG002|Reported Event|UV-detect Photos|"Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage. Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average."
10929927|NCT00709306|EG003|Reported Event|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
10929928|NCT00709319|BG000|Baseline|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year. Only one eye per participant could be enrolled.
10929929|NCT00709319|FG000|Participant Flow|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
10929930|NCT00709319|OG000|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
10929931|NCT00709319|EG000|Reported Event|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year. Only one eye per participant could be enrolled.
10929932|NCT00709592|BG000|Baseline|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
10929933|NCT00709592|BG001|Baseline|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
10929934|NCT00709592|BG002|Baseline|Total|Total of all reporting groups
10929935|NCT00709592|FG000|Participant Flow|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
10929936|NCT00709592|FG001|Participant Flow|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
10929937|NCT00709592|OG000|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
10929938|NCT00709592|OG001|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
10929939|NCT00709592|EG000|Reported Event|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
10929940|NCT00709592|EG001|Reported Event|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
10929941|NCT00709618|BG000|Baseline|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
10929942|NCT00709618|FG000|Participant Flow|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 milligrams per meters squared [mg/m^2]) intravenously (IV) once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
10929943|NCT00709618|OG000|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
10929944|NCT00709618|EG000|Reported Event|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
10929945|NCT00709696|BG000|Baseline|Placebo Varenicline|"Placebo Varenicline~Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
10929946|NCT00709696|BG001|Baseline|Varenicline|"Varenicline~Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
10929947|NCT00709696|BG002|Baseline|Total|Total of all reporting groups
10929948|NCT00709696|FG000|Participant Flow|Placebo|"Placebo Varenicline~Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
10929949|NCT00709696|FG001|Participant Flow|Varenicline|"Varenicline~Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
10929950|NCT00709696|OG000|Outcome|Placebo Varenicline|"Placebo Varenicline~Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
10929951|NCT00709696|OG001|Outcome|Varenicline|"Varenicline~Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
10929952|NCT00709696|EG000|Reported Event|Placebo Varenicline|"Placebo Varenicline~Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
10929953|NCT00709696|EG001|Reported Event|Varenicline|"Varenicline~Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
10929954|NCT00709722|BG000|Baseline|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
10929955|NCT00709722|FG000|Participant Flow|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
10929956|NCT00709722|OG000|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
10929957|NCT00709722|EG000|Reported Event|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
10929958|NCT00709735|BG000|Baseline|Non-Reactivation Propranolol (NRP)|"0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a script preparation session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences."
10929959|NCT00709735|BG001|Baseline|Reactivation Propranolol (RP)|"0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a script preparation session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences."
10929960|NCT00709735|BG002|Baseline|Total|Total of all reporting groups
10929961|NCT00709735|FG000|Participant Flow|Non-Reactivation Propranolol (NRP)|"0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a script preparation session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences."
10929962|NCT00709735|FG001|Participant Flow|Reactivation Propranolol (RP)|"0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a script preparation session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences."
10929963|NCT00709735|OG000|Outcome|Non-Reactivation Propranolol (NRP)|"0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a script preparation session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences."
10929964|NCT00709735|OG001|Outcome|Reactivation Propranolol (RP)|"0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a script preparation session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences."
10929965|NCT00709735|EG000|Reported Event|Non-Reactivation Propranolol (NRP)|"0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a script preparation session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences."
10929966|NCT00709735|EG001|Reported Event|Reactivation Propranolol (RP)|"0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a script preparation session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences."
10929967|NCT00709761|BG000|Baseline|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
10929968|NCT00709761|FG000|Participant Flow|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
10929969|NCT00709761|OG000|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
10929970|NCT00709761|EG000|Reported Event|Lapatinib (1000mg) + + Nab-Pacl|Participants received Lapatinib 1000 milligram (mg) tablets orally daily hour before or after a meal along with a Nabpaclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
10929971|NCT00709826|BG000|Baseline|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
10929972|NCT00709826|BG001|Baseline|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
10847135|NCT00281840|FG000|Participant Flow|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
10847136|NCT00281840|OG000|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
10847137|NCT00281840|OG000|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|"bevacizumab: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.~docetaxel: docetaxel IV over 1 hour once a week for 8 weeks~conventional surgery: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection~radiation therapy: radiotherapy once daily, 5 days a week, for 8 weeks"
10847138|NCT00281840|EG000|Reported Event|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
10847139|NCT00281918|BG000|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
10847140|NCT00281918|BG001|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
10847141|NCT00281918|BG002|Baseline|Total|Total of all reporting groups
10847142|NCT00281918|FG000|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
10847143|NCT00281918|FG001|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
10847144|NCT00281918|OG000|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
10847145|NCT00281918|OG001|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
10847146|NCT00281918|EG000|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
10847147|NCT00281918|EG001|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
10847148|NCT00281957|BG000|Baseline|Arm I: Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
10847149|NCT00281957|BG001|Baseline|Arm II: Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
10847150|NCT00281957|BG002|Baseline|Total|Total of all reporting groups
10847151|NCT00281957|FG000|Participant Flow|Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
10847152|NCT00281957|FG001|Participant Flow|Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
10847153|NCT00281957|OG000|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
10847154|NCT00281957|OG001|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
10847155|NCT00281957|OG000|Outcome|Sorafenib+Temsirolimus|Sorafenib and Temsirolimus
10847156|NCT00281957|OG001|Outcome|Sorafenib+Tipifarnib|Sorafenib and Tipifarnib
10847157|NCT00281957|EG000|Reported Event|Arm I|Sorafenib and Temsirolimu
11175694|NCT02030847|EG000|Reported Event|Arm1|"Phase II study to determine the efficacy & safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ & 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART-19 cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.~CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10^8 transduced CAR T cells.~CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10^7 CART-19 cells.~CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.~CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10^7), 30% on Day 2 (3x10^7-1.5x10^8), 60% on Day 3 (6x10^7-3x10^8)."
11175695|NCT02030886|BG000|Baseline|Ocular Hypertension Non Converters|Stable ocular hypertension patients monitored by TF for 24 hours.
11175696|NCT02030886|BG001|Baseline|Ocular Hypertension Converters|Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours.
11175697|NCT02030886|BG002|Baseline|Total|Total of all reporting groups
11175698|NCT02030886|FG000|Participant Flow|Ocular Hypertension Non Converters|Stable ocular hypertension patients monitored by Triggerfish (TF) for 24 hours.
11175699|NCT02030886|FG001|Participant Flow|Ocular Hypertension Converters|Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
11175700|NCT02030886|OG000|Outcome|Ocular Hypertension Non Converters|Stable ocular hypertension patients monitored by TF for 24 hours
11175701|NCT02030886|OG001|Outcome|Ocular Hypertension Converters|Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
11175702|NCT02030886|OG000|Outcome|Ocular Hypertension Non Converters|Stable ocular hypertension patients
11175703|NCT02030886|OG001|Outcome|Ocular Hypertension Converters|Ocular hypertension patients who progressed to glaucoma
10847158|NCT00281957|EG001|Reported Event|Arm II|Sorafenib and Tipifarnib
10847159|NCT00282048|BG000|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
10847160|NCT00282048|FG000|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
10847161|NCT00282048|OG000|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
10847162|NCT00282048|EG000|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
10847163|NCT00282087|BG000|Baseline|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
10847164|NCT00282087|FG000|Participant Flow|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.
10847165|NCT00282087|OG000|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
10847166|NCT00282087|OG000|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Number of major toxicity events
10847167|NCT00282087|EG000|Reported Event|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
10847168|NCT00282113|BG000|Baseline|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
10847169|NCT00282113|BG001|Baseline|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
10847170|NCT00282113|BG002|Baseline|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
10847171|NCT00282113|BG003|Baseline|Total|Total of all reporting groups
10847172|NCT00282113|FG000|Participant Flow|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
10847173|NCT00282113|FG001|Participant Flow|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
10847174|NCT00282113|FG002|Participant Flow|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
10847175|NCT00282113|OG000|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
10847176|NCT00282113|OG001|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
10847177|NCT00282113|OG002|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
10847178|NCT00282113|EG000|Reported Event|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
10847179|NCT00282113|EG001|Reported Event|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
10847180|NCT00282113|EG002|Reported Event|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
10847181|NCT00282152|BG000|Baseline|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
10849998|NCT00299494|EG003|Reported Event|Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 Follicular|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
10847182|NCT00282152|BG001|Baseline|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
10847183|NCT00282152|BG002|Baseline|Total|Total of all reporting groups
10847184|NCT00282152|FG000|Participant Flow|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
10847185|NCT00282152|FG001|Participant Flow|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
10847186|NCT00282152|OG000|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
10847187|NCT00282152|OG001|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
10847188|NCT00282152|OG001|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
10847189|NCT00282152|EG000|Reported Event|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
10847190|NCT00282152|EG001|Reported Event|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
10847191|NCT00282243|BG000|Baseline|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
10851498|NCT00306787|OG000|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
11175704|NCT02030886|EG000|Reported Event|Ocular Hypertension Non Converters|Stable ocular hypertension patients monitored by TF for 24 hours. One subject was removed from the analysis because of invalid TF output.
10929973|NCT00709826|BG002|Baseline|Total|Total of all reporting groups
10929974|NCT00709826|FG000|Participant Flow|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
10929975|NCT00709826|FG001|Participant Flow|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
10929976|NCT00709826|OG000|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
10929977|NCT00709826|OG001|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
10929978|NCT00709826|EG000|Reported Event|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
10929979|NCT00709826|EG001|Reported Event|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
10929980|NCT00709852|BG000|Baseline|Entire Study Population|Includes participants who received either treatment
10929981|NCT00709852|FG000|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
10929982|NCT00709852|FG001|Participant Flow|Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
10929983|NCT00709852|OG000|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
10929984|NCT00709852|OG001|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
10929985|NCT00709852|OG001|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
10929986|NCT00709852|OG000|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
10929987|NCT00709852|OG000|Outcome|Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
10929988|NCT00709852|OG001|Outcome|Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous). Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Unenhanced MRI.
10929989|NCT00709852|OG000|Outcome|Unenhanced Compared to Gadoteridol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
10929990|NCT00709852|OG001|Outcome|Gadoteridol-enhanced Compared to Unenhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Unenhanced MRI.
10929991|NCT00709852|OG000|Outcome|Gadobutrol-enhanced Compared to Gadoteridol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
10929992|NCT00709852|OG001|Outcome|Gadoteridol-enhanced Compared to Gadobutrol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
11175705|NCT02030886|EG001|Reported Event|Ocular Hypertension Converters|Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
10929993|NCT00709852|OG000|Outcome|Combined Gadobutrol vs. Combined Gadoteridol|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
10929994|NCT00709852|EG000|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
10929995|NCT00709852|EG001|Reported Event|Gadoteridol (ProHance)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
10929996|NCT00709878|BG000|Baseline|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
10929997|NCT00709878|BG001|Baseline|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
10929998|NCT00709878|BG002|Baseline|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
10929999|NCT00709878|BG003|Baseline|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
10930000|NCT00709878|BG004|Baseline|Total|Total of all reporting groups
10930001|NCT00709878|FG000|Participant Flow|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
10930002|NCT00709878|FG001|Participant Flow|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
10930003|NCT00709878|FG002|Participant Flow|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
10930004|NCT00709878|FG003|Participant Flow|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
11175706|NCT02031146|BG000|Baseline|Lumbar Puncture Group|Underwent lumbar puncture
11175707|NCT02031146|BG001|Baseline|No Lumbar Puncture Group|Did not undergo lumbar puncture
11175708|NCT02031146|BG002|Baseline|Total|Total of all reporting groups
11175709|NCT02031146|FG000|Participant Flow|Randomized, Lumbar Puncture (LP)|Randomized to lumbar puncture (LP) arm
11175710|NCT02031146|FG001|Participant Flow|Reenrolled, Randomized, LP|Randomised after a second enrollment, underwent LP
10930005|NCT00709878|OG000|Outcome|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
10930006|NCT00709878|OG001|Outcome|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
10930007|NCT00709878|OG002|Outcome|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
10930008|NCT00709878|OG003|Outcome|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
10930009|NCT00709878|EG000|Reported Event|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
10930010|NCT00709878|EG001|Reported Event|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
10930011|NCT00709878|EG002|Reported Event|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
10930012|NCT00709878|EG003|Reported Event|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
10930013|NCT00709891|BG000|Baseline|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
10930014|NCT00709891|FG000|Participant Flow|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
10930015|NCT00709891|OG000|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
10930016|NCT00709891|EG000|Reported Event|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
10930017|NCT00709956|BG000|Baseline|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
10930018|NCT00709956|BG001|Baseline|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
10930019|NCT00709956|BG002|Baseline|Total|Total of all reporting groups
10930020|NCT00709956|FG000|Participant Flow|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
10930021|NCT00709956|FG001|Participant Flow|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
10930022|NCT00709956|OG000|Outcome|6MWD After Placebo Treatment|
10930023|NCT00709956|OG001|Outcome|6MWD After Iloprost (5 µg) Treatment|
10930024|NCT00709956|OG000|Outcome|Borg Dyspnea Score After Placebo Treatment|
10930025|NCT00709956|OG001|Outcome|Borg Dyspnea Score After Iloprost (5 µg) Treatment|
10930026|NCT00709956|EG000|Reported Event|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
10930027|NCT00709956|EG001|Reported Event|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
10930028|NCT00709995|BG000|Baseline|Modified Regimen A (Cohort 1)|On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
10930029|NCT00709995|BG001|Baseline|Regimen A (Cohort 2)|"Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.~Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42."
10930030|NCT00709995|BG002|Baseline|Total|Total of all reporting groups
10930031|NCT00709995|FG000|Participant Flow|Modified Regimen A (Cohort 1)|"On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.~Sunitinib 50 mg was administered orally, (QD) once daily, Days 1-28, then rest (no drug given) Days 29-42."
10930032|NCT00709995|FG001|Participant Flow|Regimen A (Cohort 2)|"Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.~Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42."
10930033|NCT00709995|OG000|Outcome|Enzastaurin + Sunitinib|"Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, (TID) three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle.~Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42."
10930034|NCT00709995|OG001|Outcome|Sunitinib + Placebo|"Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42.~Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, Days 2-42."
10930035|NCT00709995|OG000|Outcome|Enzastaurin + Sunitinib|"Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle.~Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42."
10930036|NCT00709995|OG000|Outcome|Modified Regimen A (Cohort 1)|"On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle~Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42."
10930037|NCT00709995|OG001|Outcome|Regimen A (Cohort 2)|"Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.~Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42."
10930038|NCT00709995|EG000|Reported Event|Modified Regimen A (Cohort 1)|"On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.~Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42."
10930039|NCT00709995|EG001|Reported Event|Regimen A (Cohort 2)|"Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason~Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42."
10930040|NCT00710021|BG000|Baseline|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
10930041|NCT00710021|BG001|Baseline|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
10930042|NCT00710021|BG002|Baseline|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10930043|NCT00710021|BG003|Baseline|Total|Total of all reporting groups
10930044|NCT00710021|FG000|Participant Flow|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
10930045|NCT00710021|FG001|Participant Flow|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
10930046|NCT00710021|FG002|Participant Flow|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10930047|NCT00710021|OG000|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
10930048|NCT00710021|OG001|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
10930049|NCT00710021|OG002|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
11175711|NCT02031146|FG002|Participant Flow|Randomized, no LP|Randomized and did not undergo LP. Includes one person for whom LP was unsuccessful.
10930050|NCT00710021|OG003|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
10930051|NCT00710021|EG000|Reported Event|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
10930052|NCT00710021|EG001|Reported Event|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
10930053|NCT00710021|EG002|Reported Event|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10930054|NCT00710034|BG000|Baseline|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
10930055|NCT00710034|BG001|Baseline|Snus|"Oral tobacco~Oral tobacco: Snus"
10930056|NCT00710034|BG002|Baseline|Total|Total of all reporting groups
10930057|NCT00710034|FG000|Participant Flow|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
11175712|NCT02031146|FG003|Participant Flow|Not Randomized, LP|Not randomized and underwent LP.
10930058|NCT00710034|FG001|Participant Flow|Snus|"Oral tobacco~Oral tobacco: Snus"
10930059|NCT00710034|OG000|Outcome|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
10930060|NCT00710034|OG001|Outcome|Snus|"Oral tobacco~Oral tobacco: Snus"
10930061|NCT00710034|EG000|Reported Event|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
10930062|NCT00710034|EG001|Reported Event|Snus|"Oral tobacco~Oral tobacco: Snus"
10930063|NCT00710203|BG000|Baseline|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
10930064|NCT00710203|FG000|Participant Flow|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
10930065|NCT00710203|OG000|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
10930066|NCT00710203|OG001|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
11175713|NCT02031146|FG004|Participant Flow|Not Randomized, no LP|Not randomized and did not undergo LP.
11175714|NCT02031146|FG005|Participant Flow|Reenrolled, Not Randomized, no LP|Not randomized during another episode of syphilis. Did not undergo LP.
11175715|NCT02031146|FG006|Participant Flow|Reenrolled, Not Randomized, LP|Not randomized with a new episode of syphilis, underwent LP
10930067|NCT00710203|OG002|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
10930068|NCT00710203|OG003|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
10930069|NCT00710203|EG000|Reported Event|Pulsed Dye Laser|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
10930070|NCT00710203|EG001|Reported Event|Curettage|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
10930071|NCT00710203|EG002|Reported Event|Electrodesiccation|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
10930072|NCT00710203|EG003|Reported Event|No Treatment|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
10930073|NCT00710385|BG000|Baseline|Challenge Doses|This study employs a within-subjects design, all participant experience all challenge doses.
10930074|NCT00710385|FG000|Participant Flow|Intravenous Challenge Doses|This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
11175716|NCT02031146|OG000|Outcome|Lumbar Puncture (LP), Treatment Based on Cerebrospinal Fluid (CSF ) Results|Underwent lumbar puncture and treatment based on the results of cerebrospinal fluid findings. Specifically, those with abnormal CSF were treated for neurosyphilis and those without CSF abnormalities were treated for uncomplicated syphilis. The number of participants with late syphilis was too small to allow for separate analysis of early and late stages.
11175717|NCT02031146|OG001|Outcome|No Lumbar Puncture Group|Did not undergo lumbar puncture. All were treated for uncomplicated syphilis. The number of participants with late syphilis was too small to allow for separate analysis of early and late stages.
10930075|NCT00710385|OG000|Outcome|Heroin|Intravenous heroin 25 mg
10930076|NCT00710385|OG001|Outcome|Naloxone|Intravenous Naloxone HCl
10930077|NCT00710385|OG002|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
10930078|NCT00710385|OG003|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
10930079|NCT00710385|OG004|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
10930080|NCT00710385|OG005|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
10930081|NCT00710385|OG006|Outcome|Placebo|Control intravenous placebo drug administration.
10930082|NCT00710385|EG000|Reported Event|Combined for All Study Conditions|This study employed a within-subjects design, all participants experienced all study conditions.
10930083|NCT00710424|BG000|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
10930084|NCT00710424|BG001|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
10930085|NCT00710424|BG002|Baseline|Total|Total of all reporting groups
10930086|NCT00710424|FG000|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
10930087|NCT00710424|FG001|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
10930088|NCT00710424|OG000|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
10930089|NCT00710424|OG001|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
10930090|NCT00710424|EG000|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
10930091|NCT00710424|EG001|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
10930092|NCT00710554|BG000|Baseline|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
10930093|NCT00710554|BG001|Baseline|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
10930094|NCT00710554|BG002|Baseline|Total|Total of all reporting groups
10930095|NCT00710554|FG000|Participant Flow|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
10930096|NCT00710554|FG001|Participant Flow|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
10930097|NCT00710554|OG000|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
10930098|NCT00710554|OG001|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
10930099|NCT00710554|EG000|Reported Event|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
10930100|NCT00710554|EG001|Reported Event|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
10930101|NCT00710593|BG000|Baseline|Group A|Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy(HAART) for at least the six months prior to study entry.
10930102|NCT00710593|BG001|Baseline|Group B|Participants who have been receiving highly active retroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
10930103|NCT00710593|BG002|Baseline|Total|Total of all reporting groups
10930104|NCT00710593|FG000|Participant Flow|ART/HAART NAIVE|Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
10930105|NCT00710593|FG001|Participant Flow|HAART|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
10930106|NCT00710593|OG000|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-6 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
10930107|NCT00710593|OG000|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
10930108|NCT00710593|OG000|Outcome|All Study Participants|All study participants who were administered vaccine doses #1, 2, and/or 3.
10930109|NCT00710593|OG000|Outcome|All Study Participants|The results are reported for all study participants in both Group A and Group B.
10930110|NCT00710593|OG000|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
10930111|NCT00710593|OG000|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-11 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
10930112|NCT00710593|OG000|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-16 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
10930113|NCT00710593|OG000|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-18 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
10930114|NCT00710593|OG000|Outcome|Group A|Antiretroviral therapy (ART) naïve or if ART exposed, have not received highlight active antiretroviral (HAART) for at least the six months prior to study entry.
10930115|NCT00710593|OG001|Outcome|Group B|Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
10930116|NCT00710593|OG000|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
10930117|NCT00710593|OG001|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
10930118|NCT00710593|OG000|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
10930119|NCT00710593|OG000|Outcome|Lower NSSB|Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
10930120|NCT00710593|OG001|Outcome|Higher NSSB|Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).
10930121|NCT00710593|OG000|Outcome|Telephone Response System (TRS)|Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
10930122|NCT00710593|OG001|Outcome|Vaccine Report Card (VRC)|Participants at sites randomized to the VRC recorded any of their side effects. Participants were directed to call the clinical site staff or return to the clinic for evaluation if they were concerned about their signs or symptoms or if any symptoms appeared severe. Participants brought their VRC with them to all of their study visits. The completed cards were collected after all vaccine study visits were completed.
10930123|NCT00710593|OG001|Outcome|Vaccine Report Card (VRC)|Participants at sites randomized to the VRC recorded any of their side effects.
10930124|NCT00710593|EG000|Reported Event|Group A: HAART naïve or, if HAART Exposed, Has Not Received HA|Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
10930125|NCT00710593|EG001|Reported Event|Group B: Has Been Receiving HAART for > 6 Months, With Two HIV|Participants who have been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
10930126|NCT00710606|BG000|Baseline|Obese Subjects|Obese subjects (BMI 30-39.9)
10930127|NCT00710606|BG001|Baseline|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
10930128|NCT00710606|BG002|Baseline|Total|Total of all reporting groups
10930129|NCT00710606|FG000|Participant Flow|Obese Subjects|Obese subjects (BMI 30-39.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
10930130|NCT00710606|FG001|Participant Flow|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
10930131|NCT00710606|OG000|Outcome|Normal Weight|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
10930132|NCT00710606|OG001|Outcome|Obese|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
10930133|NCT00710606|OG000|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
10930134|NCT00710606|OG001|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
10930135|NCT00710606|EG000|Reported Event|Obese Subjects|Obese subjects (BMI 30-39.9)
10930136|NCT00710606|EG001|Reported Event|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
10930137|NCT00710684|BG000|Baseline|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930138|NCT00710684|BG001|Baseline|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
11175718|NCT02031146|OG000|Outcome|Lumbar Puncture (LP), Treatment Based on Cerebrospinal Fluid (CSF ) Results|Underwent lumbar puncture and treatment based on the results of cerebrospinal fluid findings. Specifically, those with abnormal CSF were treated for neurosyphilis and those without CSF abnormalities were treated for uncomplicated syphilis.
10930139|NCT00710684|BG002|Baseline|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930140|NCT00710684|BG003|Baseline|Total|Total of all reporting groups
10930141|NCT00710684|FG000|Participant Flow|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930142|NCT00710684|FG001|Participant Flow|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930143|NCT00710684|FG002|Participant Flow|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930144|NCT00710684|OG000|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930145|NCT00710684|OG001|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930146|NCT00710684|OG002|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930147|NCT00710684|OG000|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930148|NCT00710684|OG001|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
11175719|NCT02031146|OG001|Outcome|No Lumbar Puncture Group|Did not undergo lumbar puncture. All were treated for uncomplicated syphilis.
10930149|NCT00710684|OG000|Outcome|Donepezil 5 mg|Participants received a stable dose of donepezil 5 mg at least for 6 months and a stable regimen for at least 2 months. The participants received SB742457 15 mg or 35 mg or placebo matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy.
10930150|NCT00710684|OG001|Outcome|Donepezil 7.5 mg|Participants received a stable dose of donepezil 7.5 mg at least for 6 months and a stable regimen for at least 2 months. The participants received SB742457 15 mg or 35 mg or placebo matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy.
10930151|NCT00710684|OG002|Outcome|Donepezil 10 mg|Participants received a stable dose of donepezil 10 mg at least for 6 months and a stable regimen for at least 2 months. The participants received SB742457 15 mg or 35 mg or placebo matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy.
10930152|NCT00710684|OG003|Outcome|Donepezil 15 mg|Participants received a stable dose of donepezil 15 mg at least for 6 months and a stable regimen for at least 2 months. The participants received SB742457 15 mg or 35 mg or placebo matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy.
10930153|NCT00710684|EG000|Reported Event|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930154|NCT00710684|EG001|Reported Event|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930155|NCT00710684|EG002|Reported Event|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
10930156|NCT00710749|BG000|Baseline|Entire Study Population|Includes groups randomized to use the Disposable device first and the Digital device first.
10930157|NCT00710749|FG000|Participant Flow|Disposable Device First, Then Digital Device|12 voidings recorded with the disposable device in the first intervention period, followed by 12 voidings recorded with the digital device in the second intervention period.
10930158|NCT00710749|FG001|Participant Flow|Digital Device First, Then Disposable Device|12 voidings recorded with the digital device in the first intervention period, followed by 12 voidings recorded with the disposable device in the second intervention period.
10930159|NCT00710749|OG000|Outcome|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
10930160|NCT00710749|OG001|Outcome|Clinic|Voidings recorded with the clinic gold standard.
10930161|NCT00710749|OG002|Outcome|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
10930162|NCT00710749|EG000|Reported Event|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
10930163|NCT00710749|EG001|Reported Event|Clinic|Voidings recorded with the clinic gold standard.
10930164|NCT00710749|EG002|Reported Event|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
10930165|NCT00710762|BG000|Baseline|Nintedanib|Patients were treated with 250mg nintedanib twice daily
10930166|NCT00710762|BG001|Baseline|Placebo|Patients were treated with matching placebo twice daily
10930167|NCT00710762|BG002|Baseline|Total|Total of all reporting groups
10930168|NCT00710762|FG000|Participant Flow|Nintedanib|Patients were treated with 250mg nintedanib twice daily
10930169|NCT00710762|FG001|Participant Flow|Placebo|Patients were treated with matching placebo twice daily
10930170|NCT00710762|OG000|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
10930171|NCT00710762|OG001|Outcome|Placebo|Patients were treated with matching placebo twice daily
10930172|NCT00710762|EG000|Reported Event|Nintedanib|Patients were treated with 250mg nintedanib twice daily.
10930173|NCT00710762|EG001|Reported Event|Placebo|Patients were treated with matching placebo twice daily.
10930174|NCT00710814|BG000|Baseline|Leptin - Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
10930175|NCT00710814|BG001|Baseline|Placebo - Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
10930176|NCT00710814|BG002|Baseline|Total|Total of all reporting groups
10930177|NCT00710814|FG000|Participant Flow|Leptin-Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
10930178|NCT00710814|FG001|Participant Flow|Placebo-Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
10930179|NCT00710814|OG000|Outcome|Leptin Intervention|"Participants in the Leptin-Placebo arm were randomized to first receive Leptin for the first 16 weeks, and participants in the Placebo-Leptin arm were randomized to receive Leptin for the second 16 weeks.~Both Leptin and placebo were self-administered subcutaneously twice per day."
10930180|NCT00710814|OG001|Outcome|Placebo Intervention|"Participants in the Placebo-Leptin arm were randomized to receive placebo for the first 16 weeks, and participants in the Leptin-Placebo arm were randomized to receive placebo for the second 16 weeks.~Both Leptin and placebo were self-administered subcutaneously twice per day."
10930181|NCT00710814|EG000|Reported Event|Leptin Intervention|"This group Leptin Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Leptin only."
10930182|NCT00710814|EG001|Reported Event|Placebo Intervention|"This group Placebo Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Placebo only."
10930183|NCT00710840|BG000|Baseline|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
10930184|NCT00710840|BG001|Baseline|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
10930185|NCT00710840|BG002|Baseline|Total|Total of all reporting groups
10930186|NCT00710840|FG000|Participant Flow|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
10930187|NCT00710840|FG001|Participant Flow|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
10930188|NCT00710840|OG000|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
10930189|NCT00710840|OG001|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
10930190|NCT00710840|EG000|Reported Event|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
10930191|NCT00710840|EG001|Reported Event|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
10930192|NCT00710866|BG000|Baseline|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
10930193|NCT00710866|BG001|Baseline|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
10930194|NCT00710866|BG002|Baseline|Total|Total of all reporting groups
10930195|NCT00710866|FG000|Participant Flow|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
10930196|NCT00710866|FG001|Participant Flow|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
10930197|NCT00710866|OG000|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
10930198|NCT00710866|OG001|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
10930199|NCT00710866|EG000|Reported Event|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
10930200|NCT00710866|EG001|Reported Event|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
10930201|NCT00710879|BG000|Baseline|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
10930202|NCT00710879|BG001|Baseline|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
10930203|NCT00710879|BG002|Baseline|Total|Total of all reporting groups
10930204|NCT00710879|FG000|Participant Flow|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
10930205|NCT00710879|FG001|Participant Flow|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
10930206|NCT00710879|OG000|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
10930207|NCT00710879|OG001|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
10930208|NCT00710879|EG000|Reported Event|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
10930209|NCT00710879|EG001|Reported Event|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
10930210|NCT00710905|BG000|Baseline|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
10930211|NCT00710905|FG000|Participant Flow|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
10930212|NCT00710905|OG000|Outcome|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
10930213|NCT00710905|EG000|Reported Event|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
10930214|NCT00710931|BG000|Baseline|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
10930215|NCT00710931|FG000|Participant Flow|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
10930216|NCT00710931|OG000|Outcome|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
10930217|NCT00710931|EG000|Reported Event|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
10930218|NCT00710944|BG000|Baseline|Extraction Sockets|"Immediate loading of implants placed in extraction sockets.~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
10930219|NCT00710944|BG001|Baseline|Healed Ridges|"Immediate loading of implants placed in healed ridges.~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
10930220|NCT00710944|BG002|Baseline|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
10930221|NCT00710944|BG003|Baseline|Total|Total of all reporting groups
10930222|NCT00710944|FG000|Participant Flow|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
10930223|NCT00710944|FG001|Participant Flow|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
10930224|NCT00710944|FG002|Participant Flow|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
10930225|NCT00710944|OG000|Outcome|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
10930226|NCT00710944|OG001|Outcome|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
10930227|NCT00710944|OG002|Outcome|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
10930228|NCT00710944|EG000|Reported Event|Extractions Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
10930229|NCT00710944|EG001|Reported Event|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
10930230|NCT00710944|EG002|Reported Event|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
10930231|NCT00710996|BG000|Baseline|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
10930232|NCT00710996|BG001|Baseline|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
10930233|NCT00710996|BG002|Baseline|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
10930234|NCT00710996|BG003|Baseline|Total|Total of all reporting groups
10930235|NCT00710996|FG000|Participant Flow|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
10930236|NCT00710996|FG001|Participant Flow|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
10930237|NCT00710996|FG002|Participant Flow|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
10930238|NCT00710996|OG000|Outcome|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
10930239|NCT00710996|OG001|Outcome|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
10930240|NCT00710996|OG002|Outcome|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
10930241|NCT00710996|EG000|Reported Event|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
10930242|NCT00710996|EG001|Reported Event|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
10930243|NCT00710996|EG002|Reported Event|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
10930244|NCT00711009|BG000|Baseline|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
10930245|NCT00711009|BG001|Baseline|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
10930246|NCT00711009|BG002|Baseline|Total|Total of all reporting groups
10930247|NCT00711009|FG000|Participant Flow|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
10930248|NCT00711009|FG001|Participant Flow|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
10930249|NCT00711009|OG000|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
10930250|NCT00711009|OG001|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
10930251|NCT00711009|EG000|Reported Event|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
10930252|NCT00711009|EG001|Reported Event|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
10930253|NCT00711022|BG000|Baseline|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
10930254|NCT00711022|FG000|Participant Flow|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
10930255|NCT00711022|OG000|Outcome|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
10930256|NCT00711022|EG000|Reported Event|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
10930257|NCT00711100|BG000|Baseline|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
10930258|NCT00711100|FG000|Participant Flow|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
10930259|NCT00711100|OG000|Outcome|Camel Snus|Number of participants who sampled Camel Snus
11175720|NCT02031146|OG000|Outcome|Underwent Lumbar Puncture (LP), Abnormal Cerebrospinal Fluid (CSF), Treated for Neurosyphilis (NS)|Cerebrospinal fluid (CSF) white cells above 5/ul, supporting the diagnosis of neurosyphilis, and treated for neurosyphilis with antibiotics.
10930260|NCT00711100|OG001|Outcome|Marlboro Snus|Number of participants who sampled Marlboro Snus
10930261|NCT00711100|OG002|Outcome|Stonewall|Number of participants who sampled Stonewall
10930262|NCT00711100|OG003|Outcome|Ariva|Number of participants who sampled Ariva
10930263|NCT00711100|OG004|Outcome|General Snus|Number of partiicipants who sampled General Snus
10930264|NCT00711100|OG000|Outcome|Camel Snus|Number of participants who preferred this product during abstinence phase
11175721|NCT02031146|OG001|Outcome|No LP or Normal CSF and Not Treated for Neurosyphilis|Combination of participants who didn't undergo LP and those who did but had CSF white cells less than or equal to 5/ul and nonreactive cerebrospinal fluid Venereal Disease Research Laboratory (CSF-VDRL) test, and weren't treated for neurosyphilis. In other words, those who didn't undergo LP and those who did have an LP but didn't meet diagnostic criteria for neurosyphilis.
10930265|NCT00711100|OG001|Outcome|Marlboro Snus|Number of participants who preferred this product during abstinence phase
10930266|NCT00711100|OG002|Outcome|Stonewall|Number of participants who preferred this product during abstinence phase
11175722|NCT02031146|EG000|Reported Event|Underwent Lumbar Puncture|Participants who underwent lumbar puncture.
10930267|NCT00711100|OG003|Outcome|Ariva|Number of participants who preferred this product during abstinence phase
10930268|NCT00711100|EG000|Reported Event|Camel Snus|Participant who sampled Camel Snus
10930269|NCT00711100|EG001|Reported Event|Marlboro Snus|Participants who sampled Marlboro Snus
10930270|NCT00711100|EG002|Reported Event|Stonewall|Participants who sampled Stonewall
10930271|NCT00711100|EG003|Reported Event|Ariva|Participants who sampled Ariva
10930272|NCT00711100|EG004|Reported Event|General Snus|Participants who sampled General Snus
10930273|NCT00711113|BG000|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
10930274|NCT00711113|FG000|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
10930275|NCT00711113|OG000|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
10930276|NCT00711113|EG000|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
10930277|NCT00711191|BG000|Baseline|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
10930278|NCT00711191|BG001|Baseline|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
10930279|NCT00711191|BG002|Baseline|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
10930280|NCT00711191|BG003|Baseline|Total|Total of all reporting groups
10930281|NCT00711191|FG000|Participant Flow|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
10930282|NCT00711191|FG001|Participant Flow|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
11175723|NCT02031146|EG001|Reported Event|Did Not Undergo Lumbar Puncture|Participants who did not undergo lumbar puncture.
10930283|NCT00711191|FG002|Participant Flow|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
10930284|NCT00711191|OG000|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
10930285|NCT00711191|OG001|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
10930286|NCT00711191|OG002|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
10930287|NCT00711191|OG000|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
10930288|NCT00711191|OG000|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
10930289|NCT00711191|OG000|Outcome|CP-870893 Combined Dose Cohorts|"Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.~Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.~Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles."
10930290|NCT00711191|EG000|Reported Event|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
10930291|NCT00711191|EG001|Reported Event|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
10930292|NCT00711191|EG002|Reported Event|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
10930293|NCT00711243|BG000|Baseline|Cohort 1a|"Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930294|NCT00711243|BG001|Baseline|Cohort 2a|"Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930295|NCT00711243|BG002|Baseline|Cohort 3a|"Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930296|NCT00711243|BG003|Baseline|Cohort 4a|"Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930297|NCT00711243|BG004|Baseline|Cohort 5a|"Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930298|NCT00711243|BG005|Baseline|Phase II|"Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930299|NCT00711243|BG006|Baseline|Total|Total of all reporting groups
10930300|NCT00711243|FG000|Participant Flow|Cohort 1a|"Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930301|NCT00711243|FG001|Participant Flow|Cohort 2a|"Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930302|NCT00711243|FG002|Participant Flow|Cohort 3a|"Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930303|NCT00711243|FG003|Participant Flow|Cohort 4a|"Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930304|NCT00711243|FG004|Participant Flow|Cohort 5a|"Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930305|NCT00711243|FG005|Participant Flow|Phase II|"Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930306|NCT00711243|OG000|Outcome|Phase I|"Docetaxel + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. Dose for cohorts is as follows: Cohort 1a = Docetaxel 25mg/m2 Cohort 2a = Docetaxel 30mg/m2 Cohort 3a = Docetaxel 40mg/m2 Cohort 4a = Docetaxel 50mg/m2 Cohort 5a = Docetaxel 60mg/m2~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930307|NCT00711243|OG000|Outcome|Phase II|"Docetaxel 50mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~Docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~Fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~Oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930308|NCT00711243|OG000|Outcome|Cohort 1a|"Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930309|NCT00711243|OG001|Outcome|Cohort 2a|"Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930310|NCT00711243|OG002|Outcome|Cohort 3a|"Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930311|NCT00711243|OG003|Outcome|Cohort 4a|"Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930312|NCT00711243|OG004|Outcome|Cohort 5a|"Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930313|NCT00711243|OG000|Outcome|Phase I and Phase II|"Docetaxel (between 25 mg/m2 and 60mg/m2) + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930314|NCT00711243|EG000|Reported Event|Cohort 1a|"Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930315|NCT00711243|EG001|Reported Event|Cohort 2a|"Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930316|NCT00711243|EG002|Reported Event|Cohort 3a|"Docetaxel 40 mg/m2+ oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930317|NCT00711243|EG003|Reported Event|Cohort 4a|"Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930318|NCT00711243|EG004|Reported Event|Cohort 5a|"Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930319|NCT00711243|EG005|Reported Event|Phase II|"Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2~docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.~fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.~oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel"
10930320|NCT00711347|BG000|Baseline|DisCoVisc|Alcon's DisCoVisc used at time of surgery
10930321|NCT00711347|BG001|Baseline|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
10930322|NCT00711347|BG002|Baseline|Total|Total of all reporting groups
10930323|NCT00711347|FG000|Participant Flow|DisCoVisc|Alcon's DisCoVisc used at time of surgery
10930324|NCT00711347|FG001|Participant Flow|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
10930325|NCT00711347|OG000|Outcome|DisCoVisc|Alcon's DisCoVisc used at time of surgery
10930326|NCT00711347|OG001|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
10930327|NCT00711347|EG000|Reported Event|DisCoVisc|Alcon's DisCoVisc used at time of surgery
10930328|NCT00711347|EG001|Reported Event|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
10963284|NCT00871338|BG001|Baseline|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh.
10930329|NCT00711412|BG000|Baseline|Induction and Combination Treatment|"Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:~Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.~Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.~Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:~Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.~Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.~Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.~4-6 weeks later subjects will undergo evaluation for response and surgical resection."
10930330|NCT00711412|FG000|Participant Flow|Induction and Combination Treatment|"Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:~Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.~Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.~Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:~Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.~Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.~Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.~4-6 weeks later subjects will undergo evaluation for response and surgical resection."
10930331|NCT00711412|OG000|Outcome|Induction, Combination and Surgery|"Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:~Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.~Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.~Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:~Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.~Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.~Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.~4-6 weeks later subjects will undergo evaluation for response and surgical resection."
10930332|NCT00711412|OG000|Outcome|Induction and Combination Treatment|"Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:~Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.~Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.~Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:~Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.~Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.~Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.~4-6 weeks later subjects will undergo evaluation for response and surgical resection."
10930333|NCT00711412|EG000|Reported Event|Induction and Combination Treatment|"Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:~Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.~Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.~Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:~Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.~Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.~Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.~4-6 weeks later subjects will undergo evaluation for response and surgical resection."
10930334|NCT00711425|BG000|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
10930335|NCT00711425|FG000|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
10930336|NCT00711425|OG000|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
10930337|NCT00711425|EG000|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
10930338|NCT00711464|BG000|Baseline|All Participants|modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose, and placebo, in random sequence.
10930339|NCT00711464|FG000|Participant Flow|All Participants|modafinil 100 milligrams oral dose, 200 milligrams oral dose, 400 milligrams oral dose, and placebo, in randomly sequenced dosing periods.
10930340|NCT00711464|OG000|Outcome|100 mg|"modafinil 100 milligrams oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
10930341|NCT00711464|OG001|Outcome|200 mg|"modafinil 200 mg oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
10930342|NCT00711464|OG002|Outcome|400 mg|"modafinil 400 mg oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
10930343|NCT00711464|OG003|Outcome|Placebo|"Single oral placebo capsule~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
10930344|NCT00711464|EG000|Reported Event|100 mg|modafinil 100 milligrams oral dose
10930345|NCT00711464|EG001|Reported Event|200 mg|modafinil 200 mg oral dose
10930346|NCT00711464|EG002|Reported Event|400 mg|modafinil 400 mg oral dose
10930347|NCT00711464|EG003|Reported Event|Placebo|Single oral placebo capsule
10963285|NCT00871338|BG002|Baseline|Total|Total of all reporting groups
11175724|NCT02031237|BG000|Baseline|Stereotactic Radiosurgery (SRS)|"Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series.~Single Fraction Stereotactic Radiosurgery (SRS): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.~Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series."
10930348|NCT00711477|BG000|Baseline|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930349|NCT00711477|BG001|Baseline|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930350|NCT00711477|BG002|Baseline|Total|Total of all reporting groups
10930351|NCT00711477|FG000|Participant Flow|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
11357633|NCT03751657|OG000|Outcome|Insulin 287|Participants were to receive once weekly s.c. injection of insulin 287 using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once daily placebo for 26 weeks. The insulin dose was then adjusted once weekly to reach the glycaemic target of 3.9-6.0 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 3.0 mmol/L- dose reduced by 28 U, and 3.0-3.8- dose reduced by 14 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was: 3.9-6.0 mmol/L- no adjustment; 6.1-7.0 mmol/L- dose increased by 14U, and >7.0 mmol/L- dose increased by 28U. All participants used metformin with or without DPP4i at the stable, pre-trial dose and at the same frequency unless due to safety concerns.
10930352|NCT00711477|FG001|Participant Flow|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930353|NCT00711477|OG000|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930354|NCT00711477|OG001|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930355|NCT00711477|OG000|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930356|NCT00711477|OG001|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930357|NCT00711477|EG000|Reported Event|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930358|NCT00711477|EG001|Reported Event|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
10930359|NCT00711490|BG000|Baseline|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
10930360|NCT00711490|FG000|Participant Flow|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
10930361|NCT00711490|OG000|Outcome|Study Eye|The study eye was treated with sirolimus.
10930362|NCT00711490|OG001|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
10930363|NCT00711490|EG000|Reported Event|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
10930364|NCT00711516|BG000|Baseline|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
11175725|NCT02031237|BG001|Baseline|Whole Brain Radiation Therapy|"Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series.~Fractionated Whole Brain Radiation Therapy (WBRT): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.~Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series."
11175726|NCT02031237|BG002|Baseline|Total|Total of all reporting groups
11175727|NCT02031237|FG000|Participant Flow|Stereotactic Radiosurgery (SRS)|"Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series.~Single Fraction Stereotactic Radiosurgery (SRS): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.~Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series."
11175728|NCT02031237|FG001|Participant Flow|Whole Brain Radiation Therapy|"Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series.~Fractionated Whole Brain Radiation Therapy (WBRT): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.~Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series."
11175729|NCT02031237|FG002|Participant Flow|Stereotactic Radiation Therapy|Patients with brain metastases receiving fractionated (spread out over time) Stereotactic Radiation Therapy (FSRT). This intervention has not been assigned by the investigator. Treatment is decided prior to enrollment.
10930365|NCT00711516|BG001|Baseline|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
10930366|NCT00711516|BG002|Baseline|Total|Total of all reporting groups
10930367|NCT00711516|FG000|Participant Flow|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
10930368|NCT00711516|FG001|Participant Flow|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
10930369|NCT00711516|OG000|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
10930370|NCT00711516|OG001|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
10930371|NCT00711516|EG000|Reported Event|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
10930372|NCT00711516|EG001|Reported Event|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
10930373|NCT00711529|BG000|Baseline|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
10930374|NCT00711529|BG001|Baseline|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
10930375|NCT00711529|BG002|Baseline|Total|Total of all reporting groups
10930376|NCT00711529|FG000|Participant Flow|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
10930377|NCT00711529|FG001|Participant Flow|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
10930378|NCT00711529|OG000|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
10930379|NCT00711529|OG001|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
10930380|NCT00711529|EG000|Reported Event|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
10930381|NCT00711529|EG001|Reported Event|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
10930382|NCT00711594|BG000|Baseline|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
10930383|NCT00711594|BG001|Baseline|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
10930384|NCT00711594|BG002|Baseline|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930385|NCT00711594|BG003|Baseline|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930386|NCT00711594|BG004|Baseline|Total|Total of all reporting groups
10930387|NCT00711594|FG000|Participant Flow|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
10930388|NCT00711594|FG001|Participant Flow|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
10930389|NCT00711594|FG002|Participant Flow|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930390|NCT00711594|FG003|Participant Flow|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930391|NCT00711594|OG000|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
10930392|NCT00711594|OG001|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
10930393|NCT00711594|OG002|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930394|NCT00711594|OG000|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930395|NCT00711594|OG000|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
10930396|NCT00711594|OG002|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930397|NCT00711594|EG000|Reported Event|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
10930398|NCT00711594|EG001|Reported Event|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
10930399|NCT00711594|EG002|Reported Event|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930400|NCT00711594|EG003|Reported Event|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
10930401|NCT00711646|BG000|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
10930402|NCT00711646|BG001|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
10930403|NCT00711646|BG002|Baseline|Total|Total of all reporting groups
10930404|NCT00711646|FG000|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
10930405|NCT00711646|FG001|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
10930406|NCT00711646|OG000|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
10930407|NCT00711646|OG001|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
10930408|NCT00711646|EG000|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
10930409|NCT00711646|EG001|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
10930410|NCT00711711|BG000|Baseline|Manual Lymphatic Drainage|"This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery~Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery"
10930411|NCT00711711|BG001|Baseline|Relaxation|"This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery~Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery"
10930412|NCT00711711|BG002|Baseline|Total|Total of all reporting groups
10930413|NCT00711711|FG000|Participant Flow|Manual Lymphatic Drainage|"This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery~Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery"
10930414|NCT00711711|FG001|Participant Flow|Relaxation|"This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery~Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery"
10930415|NCT00711711|OG000|Outcome|Placebo|Patients who received relaxation as placebo intervention
10930416|NCT00711711|OG001|Outcome|Manual Lymphatic Drainage|Patients who received manual lymphatic drainage as the study intervention
10930417|NCT00711711|OG000|Outcome|Manual Lymphatic Drainage|"This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery~Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery"
10930418|NCT00711711|OG001|Outcome|Relaxation|"This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery~Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery"
10930419|NCT00711711|EG000|Reported Event|Manual Lymphatic Drainage|"This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery~Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery"
10930420|NCT00711711|EG001|Reported Event|Relaxation|"This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery~Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery"
10930421|NCT00711802|BG000|Baseline|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
10930422|NCT00711802|BG001|Baseline|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
10930423|NCT00711802|BG002|Baseline|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
10930424|NCT00711802|BG003|Baseline|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
10930425|NCT00711802|BG004|Baseline|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
10930426|NCT00711802|BG005|Baseline|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
10930427|NCT00711802|BG006|Baseline|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
10930428|NCT00711802|BG007|Baseline|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
10930429|NCT00711802|BG008|Baseline|Total|Total of all reporting groups
10930430|NCT00711802|FG000|Participant Flow|Age Group 1: Daptomycin|"Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
10930431|NCT00711802|FG001|Participant Flow|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
10930432|NCT00711802|FG002|Participant Flow|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
10930433|NCT00711802|FG003|Participant Flow|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
10930434|NCT00711802|FG004|Participant Flow|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
10930435|NCT00711802|FG005|Participant Flow|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
10930436|NCT00711802|FG006|Participant Flow|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
10930437|NCT00711802|FG007|Participant Flow|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
10930438|NCT00711802|OG000|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
10930439|NCT00711802|OG001|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
10930440|NCT00711802|OG002|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
10930441|NCT00711802|OG003|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
10930442|NCT00711802|OG004|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
10930443|NCT00711802|OG005|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
10930444|NCT00711802|OG006|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
10930445|NCT00711802|OG007|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
10930446|NCT00711802|OG001|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
10930447|NCT00711802|OG002|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
10930448|NCT00711802|OG003|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
10930449|NCT00711802|EG000|Reported Event|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
10930450|NCT00711802|EG001|Reported Event|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
10930451|NCT00711802|EG002|Reported Event|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
10930452|NCT00711802|EG003|Reported Event|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
10930453|NCT00711802|EG004|Reported Event|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
10930454|NCT00711802|EG005|Reported Event|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
10930455|NCT00711802|EG006|Reported Event|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
10930456|NCT00711802|EG007|Reported Event|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
10930457|NCT00711828|BG000|Baseline|Treatment|Rituximab 375 mg/m2 IV on day 1> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22> Dexamethasone 40 mg PO on days 1, 8, 15, 22
10930458|NCT00711828|FG000|Participant Flow|Treatment|Rituximab 375 mg/m2 IV on day 1> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22> Dexamethasone 40 mg PO on days 1, 8, 15, 22
10930459|NCT00711828|OG000|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
10930460|NCT00711828|EG000|Reported Event|Treatment|Dexamethasone 40 mg PO on days 1, 8, 15, 22
10930461|NCT00711867|BG000|Baseline|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
10930462|NCT00711867|BG001|Baseline|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
10930463|NCT00711867|BG002|Baseline|Total|Total of all reporting groups
10930464|NCT00711867|FG000|Participant Flow|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
10930465|NCT00711867|FG001|Participant Flow|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
10930466|NCT00711867|OG000|Outcome|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
10930467|NCT00711867|OG001|Outcome|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
10930468|NCT00711867|EG000|Reported Event|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
10930469|NCT00711867|EG001|Reported Event|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
10930470|NCT00711880|BG000|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
10930471|NCT00711880|BG001|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
10930472|NCT00711880|BG002|Baseline|Total|Total of all reporting groups
10930473|NCT00711880|FG000|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
10930474|NCT00711880|FG001|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
10930475|NCT00711880|OG000|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
10930476|NCT00711880|OG001|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
10930477|NCT00711880|EG000|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
10930478|NCT00711880|EG001|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
10930479|NCT00711958|BG000|Baseline|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
10930480|NCT00711958|BG001|Baseline|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
10930481|NCT00711958|BG002|Baseline|Total|Total of all reporting groups
10930482|NCT00711958|FG000|Participant Flow|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
10930483|NCT00711958|FG001|Participant Flow|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
10930484|NCT00711958|OG000|Outcome|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
10930485|NCT00711958|OG001|Outcome|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
10930486|NCT00711958|EG000|Reported Event|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
10930487|NCT00711958|EG001|Reported Event|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
10930488|NCT00711971|BG000|Baseline|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement~EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
10930489|NCT00711971|BG001|Baseline|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement~DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
10930490|NCT00711971|BG002|Baseline|Soy Oil Placebo|placebo: control arm
10930491|NCT00711971|BG003|Baseline|Total|Total of all reporting groups
10930492|NCT00711971|FG000|Participant Flow|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
10930493|NCT00711971|FG001|Participant Flow|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
10930494|NCT00711971|FG002|Participant Flow|Soy Oil Placebo|Soy oil placebo: control arm
10930495|NCT00711971|OG000|Outcome|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement~EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
10930496|NCT00711971|OG001|Outcome|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement~DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
10930497|NCT00711971|OG002|Outcome|Soy Oil Placebo|placebo: control arm
10930498|NCT00711971|OG002|Outcome|Soy Oil Placebo|"Soy oil~placebo: control arm"
10930499|NCT00711971|OG000|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
10930500|NCT00711971|OG001|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
10930501|NCT00711971|OG002|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
10930502|NCT00711971|EG000|Reported Event|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
10930503|NCT00711971|EG001|Reported Event|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
10930504|NCT00711971|EG002|Reported Event|Soy Oil Placebo|Soy oil placebo: control arm
10930505|NCT00711997|BG000|Baseline|BC-819 4 mg|
10930506|NCT00711997|BG001|Baseline|BC-819 8 mg|
10930507|NCT00711997|BG002|Baseline|Total|Total of all reporting groups
10930508|NCT00711997|FG000|Participant Flow|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
10930509|NCT00711997|FG001|Participant Flow|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
10930510|NCT00711997|OG000|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
10930511|NCT00711997|OG001|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
10930512|NCT00711997|OG000|Outcome|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
10930513|NCT00711997|OG001|Outcome|BC-819 8 mg|2 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
10930514|NCT00711997|EG000|Reported Event|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
10930515|NCT00711997|EG001|Reported Event|BC-819 8 mg|2 mL of 4 mg/mL for a total of 8 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
10930516|NCT00712010|BG000|Baseline|Entire Study Population|Includes groups randomized to receive 7 products in a randomized series
10930517|NCT00712010|FG000|Participant Flow|7 Proteins Were Tested Randomly|"Seven high-protein meal replacement (MR) were tested. These high-protein MR contained 29% total energy intake (TEI) of protein, 28% TEI lipids and 43% TEI glucides in 400mL meal, were iso-nitrogenous and differed in their protein quality. The proteins were:~intact whey protein~whey protein micelles~exhaustively hydrolyzed whey protein~intact casein protein~exhaustively hydrolyzed casein protein~total milk protein~exhaustively hydrolyzed milk protein The high-protein MR were a 430g liquid meal containing 30g of the tested protein."
10930518|NCT00712010|OG000|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930519|NCT00712010|OG001|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930520|NCT00712010|OG002|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930521|NCT00712010|OG003|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930522|NCT00712010|OG004|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930523|NCT00712010|OG005|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930524|NCT00712010|OG006|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930525|NCT00712010|EG000|Reported Event|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930526|NCT00712010|EG001|Reported Event|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930527|NCT00712010|EG002|Reported Event|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930528|NCT00712010|EG003|Reported Event|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930529|NCT00712010|EG004|Reported Event|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930530|NCT00712010|EG005|Reported Event|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930531|NCT00712010|EG006|Reported Event|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
10930532|NCT00712075|BG000|Baseline|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
10930533|NCT00712075|BG001|Baseline|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
10930534|NCT00712075|BG002|Baseline|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
10930535|NCT00712075|BG003|Baseline|Total|Total of all reporting groups
10930536|NCT00712075|FG000|Participant Flow|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
10930537|NCT00712075|FG001|Participant Flow|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
10930538|NCT00712075|FG002|Participant Flow|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
10930539|NCT00712075|OG000|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
10930540|NCT00712075|OG001|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
10930541|NCT00712075|OG002|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
10930542|NCT00712075|EG000|Reported Event|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
10963286|NCT00871338|FG000|Participant Flow|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh.
10930543|NCT00712075|EG001|Reported Event|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
10930544|NCT00712075|EG002|Reported Event|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
10930545|NCT00712166|BG000|Baseline|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
10930546|NCT00712166|BG001|Baseline|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
10930547|NCT00712166|BG002|Baseline|Total|Total of all reporting groups
10930548|NCT00712166|FG000|Participant Flow|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
10930549|NCT00712166|FG001|Participant Flow|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
10930550|NCT00712166|OG000|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
10930551|NCT00712166|OG001|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
10930552|NCT00712166|OG000|Outcome|Placebo TID|"Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.~Day 0: number of isolates = 104; Day 28: number of isolates = 108"
10930553|NCT00712166|OG001|Outcome|AZLI 75 mg TID|"AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.~Day 0: number of isolates = 104; Day 28: number of isolates = 76"
10930554|NCT00712166|EG000|Reported Event|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
10930555|NCT00712166|EG001|Reported Event|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
10930556|NCT00712179|BG000|Baseline|Stroke Survivors|Cross-sectional study with a single group of stroke survivors
10930557|NCT00712179|FG000|Participant Flow|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
10930558|NCT00712179|OG000|Outcome|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
10930559|NCT00712179|EG000|Reported Event|Stroke Survivors|Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions.
10930560|NCT00712244|BG000|Baseline|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
10930561|NCT00712244|BG001|Baseline|DUOVISC|DUOVISC® Viscoelastic system
10930562|NCT00712244|BG002|Baseline|Healon5|Healon5 Ophthalmic Viscosurgical Device
10930563|NCT00712244|BG003|Baseline|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
10930564|NCT00712244|BG004|Baseline|Total|Total of all reporting groups
10930565|NCT00712244|FG000|Participant Flow|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
10930566|NCT00712244|FG001|Participant Flow|DUOVISC|DUOVISC® Viscoelastic system
10930567|NCT00712244|FG002|Participant Flow|Healon5|Healon5 Ophthalmic Viscosurgical Device
10930568|NCT00712244|FG003|Participant Flow|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
10930569|NCT00712244|OG000|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
10930570|NCT00712244|OG001|Outcome|DUOVISC|DUOVISC® Viscoelastic system
10930571|NCT00712244|OG002|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
10930572|NCT00712244|OG003|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
10930573|NCT00712244|EG000|Reported Event|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
10930574|NCT00712244|EG001|Reported Event|DUOVISC|DUOVISC® Viscoelastic system
10930575|NCT00712244|EG002|Reported Event|Healon5|Healon5 Ophthalmic Viscosurgical Device
10930576|NCT00712244|EG003|Reported Event|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
10930577|NCT00712270|BG000|Baseline|Standard of Care|Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate.
10930578|NCT00712270|BG001|Baseline|Drug: Aripiprazole|"Screening and Baseline Procedures followed by 16 weeks of treatment with aripiprazole, followed by repeat of baseline procedures and referral to community care.~Aripiprazole: Target dose = 15mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible)."
10930579|NCT00712270|BG002|Baseline|Risperidone|"Screening and Baseline Procedures followed by 16 weeks of treatment with Risperidone,followed by repeat of baseline procedures and referral to community care.~Risperidone: Target Dose = 2mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible)."
10930580|NCT00712270|BG003|Baseline|Total|Total of all reporting groups
10930581|NCT00712270|FG000|Participant Flow|Entire Study Population|The study was pre-maturely terminated and limited data is available for reporting, since none of the study team members currently work in the organization, and are not able to be contacted. The randomization coding is not available, therefore, results cannot be reported per-Arm.
10930582|NCT00712270|OG000|Outcome|Standard of Care|Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate.
10930583|NCT00712270|OG001|Outcome|Drug: Aripiprazole|"Screening and Baseline Procedures followed by 16 weeks of treatment with aripiprazole, followed by repeat of baseline procedures and referral to community care.~Aripiprazole: Target dose = 15mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible)."
10930584|NCT00712270|OG002|Outcome|Risperidone|"Screening and Baseline Procedures followed by 16 weeks of treatment with Risperidone,followed by repeat of baseline procedures and referral to community care.~Risperidone: Target Dose = 2mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible)."
10930585|NCT00712270|OG000|Outcome|QTc Pre-treatment for Entire Study Population|QTc measurement via ECG prior to treatment initiation.
10930586|NCT00712270|OG001|Outcome|QTc Post-treat for Entire Study Population|QTc measurement via ECG after treatment initiation
10930587|NCT00712270|OG000|Outcome|Entire Study Population|The study was pre-maturely terminated and limited data is available for reporting, since none of the study team members currently work in the organization, and are not able to be contacted. The randomization coding is not available, therefore, results cannot be reported per-Arm.
10930588|NCT00712270|EG000|Reported Event|Entire Study Population|Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study.
10930589|NCT00712296|BG000|Baseline|Active, Phase I|Patients received 3 daily doses in which 2, 4, or 6 ASHMI capsules were administered twice a day for 7 days.
10930590|NCT00712296|BG001|Baseline|Placebo, Phase I|Patients received placebo.
10930591|NCT00712296|BG002|Baseline|Active, Phase II (ASHMI 4 Caps )|Patients received active drug, 4 caps twice a day
10930592|NCT00712296|BG003|Baseline|Active, Phase II (ASHMI 12 Caps)|Patients received active drug, 12 caps twice a day
10930593|NCT00712296|BG004|Baseline|Placebo, Phase II|Patients received placebo.
10930594|NCT00712296|BG005|Baseline|Total|Total of all reporting groups
10930595|NCT00712296|FG000|Participant Flow|Active, Phase I|Patients received 3 daily doses in which 2, 4 or 6 ASHMI capsules were administered twice a day for 7 days.
10930596|NCT00712296|FG001|Participant Flow|Placebo, Phase I|Patients received placebo. (phase I)
10930597|NCT00712296|FG002|Participant Flow|Active Phase II (ASHMI 4 Caps)|Patients received active drug. 4 caps twice a day.
10930598|NCT00712296|FG003|Participant Flow|Active, Phase II (ASHMI 12 Caps )|Patients received active drug. 12 caps twice a day.
10930599|NCT00712296|FG004|Participant Flow|Placebo, Phase II|Patients received placebo. (phase II)
10930600|NCT00712296|OG000|Outcome|Active Phase I Baseline|Baseline results for patients on ASHMI.
10930601|NCT00712296|OG001|Outcome|Active Phase I Post Treatment|Post Treatment results after 1 week for patients on ASHMI.
10930602|NCT00712296|OG002|Outcome|Placebo Phase I Baseline|Baseline results for participants who received placebo.
10930603|NCT00712296|OG003|Outcome|Placebo Phase I Post Treatment|Post Treatment results for participants who received placebo.
10930604|NCT00712296|OG000|Outcome|Placebo Phase II Baseline|Patients received placebo. at baseline.
10930605|NCT00712296|OG001|Outcome|Active Phase II (ASHMI 4 Caps) Baseline|Patients received active drug. 4 caps twice a day. at baseline.
10930606|NCT00712296|OG002|Outcome|Active Phase II (ASHMI 12 Caps) Baseline|Patients received active drug. 12 caps twice a day. at baseline.
10930607|NCT00712296|OG003|Outcome|Placebo Phase II Visit 5|Patients received placebo. at visit 5.
10930608|NCT00712296|OG004|Outcome|Active Phase II (ASHMI 4 Caps) Visit 5|Patients received active drug. 4 caps twice a day. at visit 5.
10930609|NCT00712296|OG005|Outcome|Active Phase II (ASHMI 12 Caps) Visit 5|Patients received active drug. 12 caps twice a day. at visit 5.
10930610|NCT00712296|OG006|Outcome|Placebo Phase II Visit 10|Patients received placebo. at visit 10.
10930611|NCT00712296|OG007|Outcome|Active Phase II (ASHMI 4 Caps) Visit 10|Patients received active drug. 4 caps twice a day. at visit 10.
10930612|NCT00712296|OG008|Outcome|Active Phase II (ASHMI 12 Caps) Visit 10|Patients received active drug. 12 caps twice a day. at visit 10.
10930613|NCT00712296|OG000|Outcome|Placebo Phase II Baseline|Patients received placebo at baseline
10930614|NCT00712296|OG001|Outcome|Active Phase II (ASHMI 4 Caps ) Baseline|Patients received active drug. 4 caps twice a day at baseline
10930615|NCT00712296|OG002|Outcome|Active Phase II (ASHMI 12 Caps) Baseline|Patients received active drug. 12 caps twice a day. Baseline
10930616|NCT00712296|OG008|Outcome|Active Phase II (ASHMI 12 Caps) Visit 10|Patients received active drug. 12 caps a day. at visit 10.
10930617|NCT00712296|OG002|Outcome|Active Phase II (ASHMI 12 Caps) Baseline|Patients received active drug.12 caps twice a day. at baseline.
10930618|NCT00712296|OG006|Outcome|Placebo Phase II Visit 10|Patients received placebo. at day 10.
10930619|NCT00712296|OG008|Outcome|Active Phase II (ASHMI 12 Caps) Visit 10|Patients received active drug.12 caps twice a day. at visit 10.
10930620|NCT00712296|EG000|Reported Event|Active Phase I (ASHMI 2 Caps Twice a Day)|Patients received 2, 4, or 6 ASHMI capsules were administered twice daily for 7 days.
10930621|NCT00712296|EG001|Reported Event|Placebo Phase I (2 Caps Twice a Day)|Patients received placebo. 2 caps twice a day.
10930622|NCT00712296|EG002|Reported Event|Active Phase I (ASHMI 4 Caps)|Patients received active drug. 4 caps twice a day.
10930623|NCT00712296|EG003|Reported Event|Placebo Phase I (4 Caps Twice a Day)|Patients received placebo. 4 caps twice a day.
10930624|NCT00712296|EG004|Reported Event|Active Phase I (ASHMI 6 Caps)|Patients received active drug. 6 caps twice a day.
10930625|NCT00712296|EG005|Reported Event|Placebo Phase I|Patients received placebo.
10930626|NCT00712296|EG006|Reported Event|Active Phase II (ASHMI 4 Caps Twice a Day)|Patients received active drug.Based on revised adverse event criteria on January 2010.
10930627|NCT00712296|EG007|Reported Event|Active Phase II (ASHMI 12 Caps)|Patients received active drug. 12 caps twice a day.
10930628|NCT00712296|EG008|Reported Event|Placebo Phase II|Patients received placebo.
10930629|NCT00712335|BG000|Baseline|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
10930630|NCT00712335|BG001|Baseline|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
10930631|NCT00712335|BG002|Baseline|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
10930632|NCT00712335|BG003|Baseline|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
10930633|NCT00712335|BG004|Baseline|Normal Controls|Normal controls did not receive any treatment.
10930634|NCT00712335|BG005|Baseline|Total|Total of all reporting groups
10930635|NCT00712335|FG000|Participant Flow|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
10930636|NCT00712335|FG001|Participant Flow|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
10930637|NCT00712335|FG002|Participant Flow|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
10930638|NCT00712335|FG003|Participant Flow|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
10930639|NCT00712335|FG004|Participant Flow|Normal Controls|Normal controls did not receive any treatment.
10930640|NCT00712335|OG000|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
10930641|NCT00712335|OG001|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
10930642|NCT00712335|OG002|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
10930643|NCT00712335|OG003|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
10930644|NCT00712335|OG004|Outcome|Normal Controls|Normal controls did not receive any treatment.
10930645|NCT00712335|EG000|Reported Event|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
10930646|NCT00712335|EG001|Reported Event|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
10930647|NCT00712335|EG002|Reported Event|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
10930648|NCT00712335|EG003|Reported Event|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
10930649|NCT00712335|EG004|Reported Event|Normal Controls|Normal controls did not receive any treatment.
10930650|NCT00712348|BG000|Baseline|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
10930651|NCT00712348|FG000|Participant Flow|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
10930652|NCT00712348|OG000|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
10930653|NCT00712348|EG000|Reported Event|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
10930654|NCT00712530|BG000|Baseline|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
10930655|NCT00712530|BG001|Baseline|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
10930656|NCT00712530|BG002|Baseline|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
10930657|NCT00712530|BG003|Baseline|Total|Total of all reporting groups
10930658|NCT00712530|FG000|Participant Flow|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
10930659|NCT00712530|FG001|Participant Flow|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
10930660|NCT00712530|FG002|Participant Flow|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
10930661|NCT00712530|OG000|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
10930662|NCT00712530|OG001|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
10930663|NCT00712530|OG002|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
10930664|NCT00712530|EG000|Reported Event|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
10930665|NCT00712530|EG001|Reported Event|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
10930666|NCT00712530|EG002|Reported Event|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
10930667|NCT00712543|BG000|Baseline|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
10930668|NCT00712543|BG001|Baseline|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
10930669|NCT00712543|BG002|Baseline|Total|Total of all reporting groups
10930670|NCT00712543|FG000|Participant Flow|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
10930671|NCT00712543|FG001|Participant Flow|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
10930672|NCT00712543|OG000|Outcome|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
10930673|NCT00712543|OG001|Outcome|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
10930674|NCT00712543|EG000|Reported Event|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
10930675|NCT00712543|EG001|Reported Event|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
10930676|NCT00712673|BG000|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
10930677|NCT00712673|BG001|Baseline|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
10930678|NCT00712673|BG002|Baseline|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
10930679|NCT00712673|BG003|Baseline|Total|Total of all reporting groups
10930680|NCT00712673|FG000|Participant Flow|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
10930681|NCT00712673|FG001|Participant Flow|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
10930682|NCT00712673|FG002|Participant Flow|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
10930683|NCT00712673|FG003|Participant Flow|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
10930684|NCT00712673|OG000|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
10930685|NCT00712673|OG001|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
10930686|NCT00712673|OG002|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
10930687|NCT00712673|OG000|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
10930688|NCT00712673|OG000|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
10930689|NCT00712673|OG000|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
10930690|NCT00712673|OG001|Outcome|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
10930691|NCT00712673|OG002|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
10930692|NCT00712673|OG003|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
10930693|NCT00712673|OG004|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
10930694|NCT00712673|OG005|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of lixisenatide.
10930695|NCT00712673|EG000|Reported Event|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
10930696|NCT00712673|EG001|Reported Event|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
10930697|NCT00712673|EG002|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
10930698|NCT00712673|EG003|Reported Event|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
10930699|NCT00712673|EG004|Reported Event|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
10930700|NCT00712673|EG005|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation morning and evening regimen of lixisenatide.
10930701|NCT00712712|BG000|Baseline|Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases|Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
10930702|NCT00712712|FG000|Participant Flow|Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases Localized Causing Pain|Bone metastases refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
10930703|NCT00712712|OG000|Outcome|Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases|Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
10930704|NCT00712712|EG000|Reported Event|Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases|Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
10930705|NCT00712725|BG000|Baseline|Placebo|"Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
10930706|NCT00712725|BG001|Baseline|MK3207 2.5 mg|"MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
10930707|NCT00712725|BG002|Baseline|MK3207 5 mg|"MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
10930708|NCT00712725|BG003|Baseline|MK3207 10 mg|"MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
10930709|NCT00712725|BG004|Baseline|MK3207 20 mg|"MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
10930710|NCT00712725|BG005|Baseline|MK3207 50 mg|"MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
10930711|NCT00712725|BG006|Baseline|MK3207 100 mg|"MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
10930712|NCT00712725|BG007|Baseline|MK3207 200 mg|"MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
10930713|NCT00712725|BG008|Baseline|Total|Total of all reporting groups
10930714|NCT00712725|FG000|Participant Flow|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930715|NCT00712725|FG001|Participant Flow|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930716|NCT00712725|FG002|Participant Flow|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930717|NCT00712725|FG003|Participant Flow|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930718|NCT00712725|FG004|Participant Flow|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930719|NCT00712725|FG005|Participant Flow|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930720|NCT00712725|FG006|Participant Flow|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930721|NCT00712725|FG007|Participant Flow|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930722|NCT00712725|OG000|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930723|NCT00712725|OG001|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930724|NCT00712725|OG002|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930725|NCT00712725|OG003|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930726|NCT00712725|OG004|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930727|NCT00712725|OG005|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930728|NCT00712725|OG006|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930729|NCT00712725|OG007|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930730|NCT00712725|EG000|Reported Event|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930731|NCT00712725|EG001|Reported Event|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930732|NCT00712725|EG002|Reported Event|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930733|NCT00712725|EG003|Reported Event|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930734|NCT00712725|EG004|Reported Event|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930735|NCT00712725|EG005|Reported Event|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930736|NCT00712725|EG006|Reported Event|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930737|NCT00712725|EG007|Reported Event|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
10930738|NCT00712920|BG000|Baseline|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930739|NCT00712920|BG001|Baseline|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930740|NCT00712920|BG002|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930741|NCT00712920|BG003|Baseline|Total|Total of all reporting groups
10930742|NCT00712920|FG000|Participant Flow|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930743|NCT00712920|FG001|Participant Flow|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930744|NCT00712920|FG002|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930745|NCT00712920|OG000|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930746|NCT00712920|OG001|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930747|NCT00712920|OG002|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930748|NCT00712920|EG000|Reported Event|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930749|NCT00712920|EG001|Reported Event|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930750|NCT00712920|EG002|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
10930751|NCT00712959|BG000|Baseline|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
10930752|NCT00712959|BG001|Baseline|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
10930753|NCT00712959|BG002|Baseline|Total|Total of all reporting groups
10930754|NCT00712959|FG000|Participant Flow|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
10930755|NCT00712959|FG001|Participant Flow|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
10930756|NCT00712959|OG000|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
10930757|NCT00712959|OG001|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
10930758|NCT00712959|EG000|Reported Event|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
10930759|NCT00712959|EG001|Reported Event|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
10930760|NCT00712985|BG000|Baseline|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
10930761|NCT00712985|FG000|Participant Flow|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
10930762|NCT00712985|OG000|Outcome|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
10930763|NCT00712985|EG000|Reported Event|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
10930764|NCT00713219|BG000|Baseline|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
10930765|NCT00713219|FG000|Participant Flow|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
10930766|NCT00713219|OG000|Outcome|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
10930767|NCT00713219|EG000|Reported Event|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
10930768|NCT00713284|BG000|Baseline|Sirolimus Conversion|All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.
10930769|NCT00713284|FG000|Participant Flow|Sirolimus Conversion|All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.
10930770|NCT00713284|OG000|Outcome|Sirolimus Conversion|All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.
10930771|NCT00713284|EG000|Reported Event|Sirolimus Conversion|All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.
10930772|NCT00713310|BG000|Baseline|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
10930773|NCT00713310|BG001|Baseline|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
10930774|NCT00713310|BG002|Baseline|Total|Total of all reporting groups
10930775|NCT00713310|FG000|Participant Flow|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
10930776|NCT00713310|FG001|Participant Flow|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
10930777|NCT00713310|OG000|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
10930778|NCT00713310|OG001|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
10930779|NCT00713310|EG000|Reported Event|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
10930780|NCT00713310|EG001|Reported Event|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
10930781|NCT00713323|BG000|Baseline|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
10930782|NCT00713323|FG000|Participant Flow|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
10930783|NCT00713323|OG000|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
10930784|NCT00713323|EG000|Reported Event|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
10930785|NCT00713349|BG000|Baseline|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator~Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.~White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days~Each subject acting as their own control"
10930786|NCT00713349|FG000|Participant Flow|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator~Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.~White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days~Each subject acting as their own control"
10930787|NCT00713349|OG000|Outcome|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
10930788|NCT00713349|OG001|Outcome|Placebo Control|White Petrolatum : each subject acting as their own control
10930789|NCT00713349|EG000|Reported Event|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
10930790|NCT00713349|EG001|Reported Event|Placebo Control|White Petrolatum : each subject acting as their own control
10930791|NCT00713427|BG000|Baseline|WallFlex Stent|"All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.~WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent."
10930792|NCT00713427|FG000|Participant Flow|WallFlex Stent|"All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.~WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent."
10930793|NCT00713427|OG000|Outcome|WallFlex Stent|"All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.~WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent."
10930794|NCT00713427|EG000|Reported Event|WallFlex Stent|"All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.~WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent."
10963287|NCT00871338|FG001|Participant Flow|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh.
10963288|NCT00871338|OG000|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
10963289|NCT00871338|OG001|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
10963290|NCT00871338|EG000|Reported Event|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh.
10963291|NCT00871338|EG001|Reported Event|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh.
10963292|NCT00871377|BG000|Baseline|Baseline|The study began on Visit 1 when baseline data was collected and Intervention 1 was initiated.
10963293|NCT00871377|FG000|Participant Flow|P L H|Placebo, then Low Dose, then High Dose
10963294|NCT00871377|FG001|Participant Flow|P H L|Placebo, then High Dose, then Low Dose
10963295|NCT00871377|FG002|Participant Flow|L H P|Low Dose, then High Dose, then Placebo
10963296|NCT00871377|FG003|Participant Flow|L P H|Low Dose, then Placebo, then High Dose
10963297|NCT00871377|FG004|Participant Flow|H L P|High Dose, then Low Dose, then Placebo
10963298|NCT00871377|FG005|Participant Flow|H P L|High Dose, then Placebo, then Low Dose
10963299|NCT00871377|OG000|Outcome|Placebo|Corn Oil - 6 capsules per day
10963300|NCT00871377|OG001|Outcome|Fish Oil Low Dose|Fish Oil - 3 capsules per day Corn Oil - 3 capsules per day EPA+DHA = 1080 mg/day
10963301|NCT00871377|OG002|Outcome|Fish OIl High Dose|Fish Oil - 6 capsules per day EPA+DHA = 2160 mg/day
10963302|NCT00871377|EG000|Reported Event|High Dose|High Dose Fish Oil Intervention
10963303|NCT00871377|EG001|Reported Event|Low Dose|Low Dose Fish Oil Intervention
10963304|NCT00871377|EG002|Reported Event|Placebo|Corn Oil Placebo
11240639|NCT02481050|FG000|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Participants with histologically confirmed human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 milligram per square meter (mg/m^2), intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
10963305|NCT00871403|BG000|Baseline|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
10963306|NCT00871403|BG001|Baseline|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
10963307|NCT00871403|BG002|Baseline|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
10963308|NCT00871403|BG003|Baseline|Total|Total of all reporting groups
10963309|NCT00871403|FG000|Participant Flow|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
10930795|NCT00713479|BG000|Baseline|Total Sample|Includes only subjects who completed both components of the trial.
10930796|NCT00713479|FG000|Participant Flow|Placebo, Then Varenicline|Placebo drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the varenicline condition is started. Varenicline is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
10930797|NCT00713479|FG001|Participant Flow|Varenicline, Then Placebo|Varenicline dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the placebo condition is started. Placebo is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
10930798|NCT00713479|OG000|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
10930799|NCT00713479|OG001|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
10930800|NCT00713479|OG000|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
10930801|NCT00713479|OG001|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
10930802|NCT00713479|EG000|Reported Event|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
10930803|NCT00713479|EG001|Reported Event|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
10930804|NCT00713544|BG000|Baseline|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
10930805|NCT00713544|BG001|Baseline|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
10930806|NCT00713544|BG002|Baseline|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
10930807|NCT00713544|BG003|Baseline|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
10930808|NCT00713544|BG004|Baseline|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
10930809|NCT00713544|BG005|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
10930810|NCT00713544|BG006|Baseline|Total|Total of all reporting groups
10930811|NCT00713544|FG000|Participant Flow|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
10930812|NCT00713544|FG001|Participant Flow|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
10930813|NCT00713544|FG002|Participant Flow|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
10930814|NCT00713544|FG003|Participant Flow|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
10930815|NCT00713544|FG004|Participant Flow|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
10930816|NCT00713544|FG005|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
10930817|NCT00713544|OG000|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
10930818|NCT00713544|OG001|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
10930819|NCT00713544|OG002|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
10930820|NCT00713544|OG003|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
10930821|NCT00713544|OG004|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
10930822|NCT00713544|OG005|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
10930823|NCT00713544|EG000|Reported Event|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
10930824|NCT00713544|EG001|Reported Event|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
10930825|NCT00713544|EG002|Reported Event|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
10930826|NCT00713544|EG003|Reported Event|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
10930827|NCT00713544|EG004|Reported Event|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
10930828|NCT00713544|EG005|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
10930829|NCT00713583|BG000|Baseline|Levodopa Pharmacotherapy|Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
10930830|NCT00713583|BG001|Baseline|Placebo|Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
10930831|NCT00713583|BG002|Baseline|Total|Total of all reporting groups
10930832|NCT00713583|FG000|Participant Flow|Levodopa Pharmacotherapy|Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
10930833|NCT00713583|FG001|Participant Flow|Placebo|Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
11175730|NCT02031237|OG000|Outcome|Stereotactic Radiosurgery (SRS)|"Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed prior to SRS, at 1-2 weeks post SRS, and 1 month after SRS. The MRI scan will include a routine clinical MRI series.~Single Fraction Stereotactic Radiosurgery (SRS): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.~Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series."
11175731|NCT02031237|OG001|Outcome|Whole Brain Radiation Therapy (High Leaky Lesions)|"43 Lesions from 21 Patients were highly leaky.~Participants with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed prior to RT, at 1-2 weeks post RT and 1 month after RT. The MRI scan will include a routine clinical MRI series.~An in-house program developed to estimate vascular permeability voxel-by voxel was used to classify this WBRT group as  High Leaky (more permeable) based upon their baseline MRI scan."
11175732|NCT02031237|OG002|Outcome|Whole Brain Radiation Therapy (Low Leaky Lesions)|"7 Lesions from 21 Patients were classified as low leaky.~Participants with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed prior to RT, at 1-2 weeks post RT and 1 month after RT. The MRI scan will include a routine clinical MRI series.~An in-house program developed to estimate vascular permeability voxel-by voxel was used to classify this WBRT group as  High Leaky (more permeable) based upon their baseline MRI scan."
11175733|NCT02031237|EG000|Reported Event|Stereotactic Radiosurgery (SRS)|"Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series.~Single Fraction Stereotactic Radiosurgery (SRS): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.~Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series."
10930834|NCT00713583|OG000|Outcome|Levodopa Pharmacotherapy|Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
10930835|NCT00713583|OG001|Outcome|Placebo|Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
10930836|NCT00713583|EG000|Reported Event|Levodopa Pharmacotherapy|Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
10930837|NCT00713583|EG001|Reported Event|Placebo|Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
10930838|NCT00713609|BG000|Baseline|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face
10930839|NCT00713609|BG001|Baseline|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930840|NCT00713609|BG002|Baseline|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930841|NCT00713609|BG003|Baseline|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
11175734|NCT02031237|EG001|Reported Event|Whole Brain Radiation Therapy|"Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.~MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series.~Fractionated Whole Brain Radiation Therapy (WBRT): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.~Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series."
11175735|NCT02031276|BG000|Baseline|Double-blind Placebo IV|Participants randomized in Period 1 to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
11175736|NCT02031276|BG001|Baseline|Double-blind Risankizumab 200 mg IV|Participants randomized in Period 1 to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
11175737|NCT02031276|BG002|Baseline|Double-blind Risankizumab 600 mg IV|Participants randomized in Period 1 to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
11175738|NCT02031276|BG003|Baseline|Total|Total of all reporting groups
11175739|NCT02031276|FG000|Participant Flow|Double-blind Placebo IV|Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
11175740|NCT02031276|FG001|Participant Flow|Double-blind Risankizumab 200 mg IV|Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
11175741|NCT02031276|FG002|Participant Flow|Double-blind Risankizumab 600 mg IV|Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
11175742|NCT02031276|OG000|Outcome|Double-blind Placebo IV (Period 1)|Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.
10930842|NCT00713609|BG004|Baseline|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930843|NCT00713609|BG005|Baseline|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930844|NCT00713609|BG006|Baseline|Total|Total of all reporting groups
10930845|NCT00713609|FG000|Participant Flow|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face
10930846|NCT00713609|FG001|Participant Flow|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930847|NCT00713609|FG002|Participant Flow|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930848|NCT00713609|FG003|Participant Flow|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930849|NCT00713609|FG004|Participant Flow|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930850|NCT00713609|FG005|Participant Flow|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930851|NCT00713609|OG000|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
11175743|NCT02031276|OG001|Outcome|Double-blind Risankizumab 200 mg IV (Period 1)|Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.
11175744|NCT02031276|OG002|Outcome|Double-blind Risankizumab 600 mg IV (Period 1)|Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.
11175745|NCT02031276|OG003|Outcome|Double-blind Risankizumab 200 + 600 mg IV (Period 1)|Participants randomized to receive double-blind risankizumab 200 mg and 600 mg by intravenous (IV) injection for 12 weeks.
11175746|NCT02031276|EG000|Reported Event|Double-blind Placebo IV (Period 1)|Participants received double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.
11175747|NCT02031276|EG001|Reported Event|Double-blind Risankizumab 200 mg IV (Period 1)|Participants received double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.
11175748|NCT02031276|EG002|Reported Event|Double-blind Risankizumab 600 mg IV (Period 1)|Participants administered double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.
11175749|NCT02031276|EG003|Reported Event|Open-label Risankizumab 600 mg IV (Period 2)|Participants administered open-label risankizumab 600 mg by intravenous (IV) injection for 12 weeks.
11175750|NCT02031276|EG004|Reported Event|Open-label Risankizumab 180 mg SC (Period 3)|Participants administered open-label risankizumab 600 mg by subcutaneous (SC) injection for 12 weeks.
11175751|NCT02031276|EG005|Reported Event|All Risankizumab|Participants administered at least one dose of risankizumab.
10930852|NCT00713609|OG001|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930853|NCT00713609|OG002|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930854|NCT00713609|OG003|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930855|NCT00713609|OG004|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930856|NCT00713609|OG005|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930857|NCT00713609|EG000|Reported Event|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930858|NCT00713609|EG001|Reported Event|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930859|NCT00713609|EG002|Reported Event|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930860|NCT00713609|EG003|Reported Event|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930861|NCT00713609|EG004|Reported Event|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
10930862|NCT00713609|EG005|Reported Event|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
11175752|NCT02031302|BG000|Baseline|Lotus Valve|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement."
10930863|NCT00713648|BG000|Baseline|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
10930864|NCT00713648|FG000|Participant Flow|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
10930865|NCT00713648|OG000|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
10930866|NCT00713648|EG000|Reported Event|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
10930867|NCT00713661|BG000|Baseline|Group 1: Open Surgery Lower|
10930868|NCT00713661|BG001|Baseline|Group 2: Open Surgery Middle/Upper|
10930869|NCT00713661|BG002|Baseline|Group 3: Laparoscopic Surgery Lower|
10930870|NCT00713661|BG003|Baseline|Group 4: Laparoscopic Surgery Middle/Upper|
10930871|NCT00713661|BG004|Baseline|Total|Total of all reporting groups
10851499|NCT00306787|OG001|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
10851500|NCT00306787|EG000|Reported Event|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
10851501|NCT00306787|EG001|Reported Event|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
10851502|NCT00306852|BG000|Baseline|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
10851503|NCT00306852|BG001|Baseline|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
10851504|NCT00306852|BG002|Baseline|Total|Total of all reporting groups
10851505|NCT00306852|FG000|Participant Flow|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
10851506|NCT00306852|FG001|Participant Flow|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
10851507|NCT00306852|OG000|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
10851508|NCT00306852|OG001|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
10851509|NCT00306852|EG000|Reported Event|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
10851510|NCT00306852|EG001|Reported Event|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
10851511|NCT00306891|BG000|Baseline|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
10851512|NCT00306891|BG001|Baseline|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
10851513|NCT00306891|BG002|Baseline|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
10851514|NCT00306891|BG003|Baseline|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
10851515|NCT00306891|BG004|Baseline|Total|Total of all reporting groups
10851516|NCT00306891|FG000|Participant Flow|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
10851517|NCT00306891|FG001|Participant Flow|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
10851518|NCT00306891|FG002|Participant Flow|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
10851519|NCT00306891|FG003|Participant Flow|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
10851520|NCT00306891|OG000|Outcome|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
10851521|NCT00306891|OG001|Outcome|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
10851522|NCT00306891|OG000|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
10851523|NCT00306891|OG001|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
10851524|NCT00306891|OG000|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
10851525|NCT00306891|OG001|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
10851526|NCT00306891|EG000|Reported Event|Cediranib 45 mg Part A|Part A: Cediranib 45 mg
10851527|NCT00306891|EG001|Reported Event|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
10851528|NCT00306891|EG002|Reported Event|Cediranib 30 - 90 mg Dose Escalation|Cediranib 30 - 90 mg Dose Escalation
10851529|NCT00306917|BG000|Baseline|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
10851530|NCT00306917|BG001|Baseline|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
10851531|NCT00306917|BG002|Baseline|Total|Total of all reporting groups
10930872|NCT00713661|FG000|Participant Flow|Group 1: Open Surgery Lower|Open colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
10930873|NCT00713661|FG001|Participant Flow|Group 2: Open Surgery Middle/Upper|Open colorectal resection. The anastomotic line in the middle/upper segment 5-12 cm from the anal verge.
10930874|NCT00713661|FG002|Participant Flow|Group 3: Laparoscopic Surgery Lower|Laparoscopic colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
10930875|NCT00713661|FG003|Participant Flow|Group 4: Laparoscopic Surgery Middle/Upper|Laparasocopic colorectal resection. The anastomotic line in the mid/upper segment 5-12 cm from the anal verge.
10930876|NCT00713661|OG000|Outcome|Group 1: Open Surgery Lower|
10930877|NCT00713661|OG001|Outcome|Group 2: Open Surgery Middle/Upper|
10930878|NCT00713661|OG002|Outcome|Group 3: Laparoscopic Surgery Lower|
10930879|NCT00713661|OG003|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
10930880|NCT00713661|EG000|Reported Event|Group 1: Open Surgery Lower|
10930881|NCT00713661|EG001|Reported Event|Group 2: Open Surgery Middle/Upper|
10930882|NCT00713661|EG002|Reported Event|Group 3: Laparoscopic Surgery Lower|
10930883|NCT00713661|EG003|Reported Event|Group 4: Laparoscopic Surgery Middle/Upper|
11357634|NCT03751657|OG001|Outcome|Insulin Glargine|Participants were to receive once daily s.c injection of Insulin glargine using 10 ml vial and syringe at a starting dose of 10 U and once weekly placebo for 26 weeks. The insulin dose was then adjusted to reach the glycaemic target of 3.9-6.0 mmol/L based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 3.0 mmol/L- dose reduced by 4 U, and 3.0-3.8 dose reduced by 2 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was: 3.9-6.0 mmol/L- no adjustment; 6.1-7.0 mmol/L- dose increased by 2 U, and >7.0 mmol/L- dose increased by 4 U. All participants used metformin with or without DPP4i at the stable, pre-trial dose and at the same frequency unless due to safety concerns.
11357635|NCT03751657|EG000|Reported Event|Insulin 287|Participants were to receive once weekly s.c. injection of insulin 287 using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once daily placebo for 26 weeks. The insulin dose was then adjusted once weekly to reach the glycaemic target of 3.9-6.0 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 3.0 mmol/L- dose reduced by 28 U, and 3.0-3.8- dose reduced by 14 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was: 3.9-6.0 mmol/L- no adjustment; 6.1-7.0 mmol/L- dose increased by 14U, and >7.0 mmol/L- dose increased by 28U. All participants used metformin with or without DPP4i at the stable, pre-trial dose and at the same frequency unless due to safety concerns.
11377046|NCT00346164|FG001|Participant Flow|Arm B: Low Risk; Adjuvant Radiotherapy|"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy"
10930884|NCT00713700|BG000|Baseline|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
10930885|NCT00713700|FG000|Participant Flow|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
10930886|NCT00713700|OG000|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
10930887|NCT00713700|EG000|Reported Event|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
10930888|NCT00713817|BG000|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
10930889|NCT00713817|BG001|Baseline|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
10930890|NCT00713817|BG002|Baseline|Total|Total of all reporting groups
10930891|NCT00713817|FG000|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
10930892|NCT00713817|FG001|Participant Flow|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
10930893|NCT00713817|OG000|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
10930894|NCT00713817|OG001|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
10930895|NCT00713817|EG000|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
10930896|NCT00713817|EG001|Reported Event|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
10930897|NCT00713830|BG000|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10930898|NCT00713830|BG001|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10930899|NCT00713830|BG002|Baseline|Total|Total of all reporting groups
10930900|NCT00713830|FG000|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10930901|NCT00713830|FG001|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10930902|NCT00713830|OG000|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
10930903|NCT00713830|OG001|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
10930904|NCT00713830|EG000|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
10930905|NCT00713830|EG001|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
10930906|NCT00714051|BG000|Baseline|Falls Prevention Training Group|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
10930907|NCT00714051|BG001|Baseline|Control Group|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
10930908|NCT00714051|BG002|Baseline|Total|Total of all reporting groups
10930909|NCT00714051|FG000|Participant Flow|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
10930910|NCT00714051|FG001|Participant Flow|Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
10930911|NCT00714051|OG000|Outcome|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
10930912|NCT00714051|OG001|Outcome|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
10930913|NCT00714051|EG000|Reported Event|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
11175753|NCT02031302|BG001|Baseline|Lotus With Depth Guard|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement."
11175754|NCT02031302|BG002|Baseline|Total|Total of all reporting groups
11175755|NCT02031302|FG000|Participant Flow|Lotus Valve|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.~These are the 1 year outcome."
11175756|NCT02031302|FG001|Participant Flow|Lotus With Depth Guard|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.~These are the 30 days outcome. Study ended at 30 days. No 1 year data collected."
11175757|NCT02031302|OG000|Outcome|Lotus Valve|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement."
11175758|NCT02031302|OG001|Outcome|Lotus With Depth Guard|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement."
11175759|NCT02031302|EG000|Reported Event|Lotus Valve (30 Day Follow Up)|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement."
11175760|NCT02031302|EG001|Reported Event|Lotus Valve (1 Year Follow Up)|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement."
11175761|NCT02031302|EG002|Reported Event|Lotus With Depth Guard (30 Day Follow Up)|"All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard.~Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement."
11175762|NCT02031432|BG000|Baseline|Cebranopadol|Cebranopadol: Cebranopadol 200 µg to 1000 µg per day taken once a day in the morning.
11175763|NCT02031432|FG000|Participant Flow|Cebranopadol|Cebranopadol: Cebranopadol 200 µg to 1000 µg per day taken once a day in the morning.
11175764|NCT02031432|OG000|Outcome|Cebranopadol|Cebranopadol (GRT6005) 200 µg to 1000 µg per day taken once a day in the morning.
10930914|NCT00714051|EG001|Reported Event|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
10930915|NCT00714168|BG000|Baseline|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
11175765|NCT02031432|EG000|Reported Event|Cebranopadol|"Cebranopadol: Cebranopadol 200 µg to 1000 µg per day taken once a day in the morning.~Subjects who completed the treatment in KF6005/07 and were willing to participate in this trial went into a Titration Phase (approximately 2 weeks). During the Titration Phase, the subjects were titrated to their individual optimal daily dose of cebranopadol, defined as a balance between self-reported analgesia and side effects."
10930916|NCT00714168|BG001|Baseline|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
10930917|NCT00714168|BG002|Baseline|Total|Total of all reporting groups
11175766|NCT02031458|BG000|Baseline|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
11175767|NCT02031458|BG001|Baseline|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
11175768|NCT02031458|BG002|Baseline|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
11175769|NCT02031458|BG003|Baseline|Total|Total of all reporting groups
11175770|NCT02031458|FG000|Participant Flow|Cohort 1: First Line Atezolizumab|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
10930918|NCT00714168|FG000|Participant Flow|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
10930919|NCT00714168|FG001|Participant Flow|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
10930920|NCT00714168|OG000|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
10930921|NCT00714168|OG001|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
11175771|NCT02031458|FG001|Participant Flow|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in Eastern Cooperative Oncology Group (ECOG) performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
11175772|NCT02031458|FG002|Participant Flow|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
11175773|NCT02031458|OG000|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
11175774|NCT02031458|OG001|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
10930922|NCT00714168|EG000|Reported Event|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
10930923|NCT00714168|EG001|Reported Event|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
10930924|NCT00714233|BG000|Baseline|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
10930925|NCT00714233|BG001|Baseline|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
10930926|NCT00714233|BG002|Baseline|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
10930927|NCT00714233|BG003|Baseline|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
10930928|NCT00714233|BG004|Baseline|Total|Total of all reporting groups
10930929|NCT00714233|FG000|Participant Flow|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
10930930|NCT00714233|FG001|Participant Flow|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
10930931|NCT00714233|FG002|Participant Flow|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
10930932|NCT00714233|FG003|Participant Flow|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
10930933|NCT00714233|OG000|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
10930934|NCT00714233|OG001|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
10930935|NCT00714233|OG002|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
10930936|NCT00714233|OG003|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
10930937|NCT00714233|OG000|Outcome|Lifestyle Program|Subjects enrolled in a nutrition and exercise program
10930938|NCT00714233|OG000|Outcome|Metformin|Group assigned to metformin with free androgen index measured
10930939|NCT00714233|OG001|Outcome|Oral Contraceptive|group assigned to oral contraceptive for 24 weeks
10930940|NCT00714233|OG002|Outcome|Lifestle|Those assigned to a nutrition and exercise program
10930941|NCT00714233|OG003|Outcome|Placebo to Metformin|Matched to metformin pill
10930942|NCT00714233|EG000|Reported Event|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
10930943|NCT00714233|EG001|Reported Event|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
10930944|NCT00714233|EG002|Reported Event|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
10930945|NCT00714233|EG003|Reported Event|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
10930946|NCT00714259|BG000|Baseline|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
10930947|NCT00714259|FG000|Participant Flow|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
10930948|NCT00714259|OG000|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
10930949|NCT00714259|EG000|Reported Event|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
10930950|NCT00714272|BG000|Baseline|A - Verum, Granulocytapheresis|"Granulocytapheresis treatment~Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks."
10930951|NCT00714272|BG001|Baseline|B - Control, Sham Treatment|"Sham device treatment~Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks."
10930952|NCT00714272|BG002|Baseline|Total|Total of all reporting groups
10930953|NCT00714272|FG000|Participant Flow|A - Verum, Granulocytapheresis|"Granulocytapheresis treatment~Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks."
10930954|NCT00714272|FG001|Participant Flow|B - Control, Sham Treatment|"Sham device treatment~Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks."
10930955|NCT00714272|OG000|Outcome|A - Verum, Granulocytapheresis|"Granulocytapheresis treatment~Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks."
10930956|NCT00714272|OG001|Outcome|B - Control, Sham Treatment|"Sham device treatment~Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks."
10930957|NCT00714272|EG000|Reported Event|A - Verum, Granulocytapheresis|"Granulocytapheresis treatment~Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks."
10930958|NCT00714272|EG001|Reported Event|B - Control, Sham Treatment|"Sham device treatment~Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks."
10930959|NCT00714285|BG000|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930960|NCT00714285|BG001|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930961|NCT00714285|BG002|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930962|NCT00714285|BG003|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930963|NCT00714285|BG004|Baseline|Total|Total of all reporting groups
10930964|NCT00714285|FG000|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930965|NCT00714285|FG001|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930966|NCT00714285|FG002|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930967|NCT00714285|FG003|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930968|NCT00714285|OG000|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930969|NCT00714285|OG001|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
11240640|NCT02481050|OG000|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
10930970|NCT00714285|OG002|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
10930971|NCT00714285|OG003|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930972|NCT00714285|OG002|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930973|NCT00714285|OG003|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930974|NCT00714285|EG000|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930975|NCT00714285|EG001|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930976|NCT00714285|EG002|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930977|NCT00714285|EG003|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
10930978|NCT00714311|BG000|Baseline|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
10930979|NCT00714311|BG001|Baseline|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
10930980|NCT00714311|BG002|Baseline|Total|Total of all reporting groups
10930981|NCT00714311|FG000|Participant Flow|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
10930982|NCT00714311|FG001|Participant Flow|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
10930983|NCT00714311|OG000|Outcome|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
10930984|NCT00714311|OG001|Outcome|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
10930985|NCT00714311|EG000|Reported Event|Transference-Focused Psychotherapy|"Transference-Focused Psychotherapy (TFP)~Transference-Focused Psychotherapy: Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week"
10930986|NCT00714311|EG001|Reported Event|Treatment by Experienced Community Psychotherapists|"treatment by experienced community psychotherapists (ECP)~treatment by experienced community psychotherapists: Outpatient psychotherapy in private practices or outpatient units of psychiatric hospitals. Licensed psychotherapists with experience and special interest in the treatment of borderline patients are treating according to the method they have learned."
10930987|NCT00714389|BG000|Baseline|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
10930988|NCT00714389|FG000|Participant Flow|Spontaneous Uroflow Measurements|Spontaneous voids of volunteers working in the care facility will recorded by uroflowmetry.
10930989|NCT00714389|OG000|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
10930990|NCT00714389|EG000|Reported Event|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
10930991|NCT00714415|BG000|Baseline|BeneFIX: On Demand|Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
10930992|NCT00714415|BG001|Baseline|BeneFIX: Prophylaxis|Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
10930993|NCT00714415|BG002|Baseline|Total|Total of all reporting groups
10930994|NCT00714415|FG000|Participant Flow|BeneFIX: On-Demand|Participants were treated with intravenous (IV) injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 8.7 years in this study.
10930995|NCT00714415|FG001|Participant Flow|BeneFIX: Prophylaxis|Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
10930996|NCT00714415|OG000|Outcome|BeneFIX: On Demand|Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
10930997|NCT00714415|OG001|Outcome|BeneFIX: Prophylaxis|Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
10930998|NCT00714415|EG000|Reported Event|BeneFIX: On Demand|Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
10930999|NCT00714415|EG001|Reported Event|BeneFIX: Prophylaxis|Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
10931000|NCT00714493|BG000|Baseline|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
10931001|NCT00714493|FG000|Participant Flow|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
10931002|NCT00714493|OG000|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
10931003|NCT00714493|EG000|Reported Event|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
10931004|NCT00714571|BG000|Baseline|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
10931005|NCT00714571|BG001|Baseline|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
10931006|NCT00714571|BG002|Baseline|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
10931007|NCT00714571|BG003|Baseline|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
10931008|NCT00714571|BG004|Baseline|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
10931009|NCT00714571|BG005|Baseline|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
10931010|NCT00714571|BG006|Baseline|Total|Total of all reporting groups
10931011|NCT00714571|FG000|Participant Flow|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
10931012|NCT00714571|FG001|Participant Flow|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
10931013|NCT00714571|FG002|Participant Flow|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
10931014|NCT00714571|FG003|Participant Flow|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
10931015|NCT00714571|FG004|Participant Flow|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
10931016|NCT00714571|FG005|Participant Flow|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
10931017|NCT00714571|OG000|Outcome|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
10931018|NCT00714571|OG001|Outcome|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
10931019|NCT00714571|OG002|Outcome|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
10931020|NCT00714571|OG003|Outcome|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
10931021|NCT00714571|OG004|Outcome|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
10931022|NCT00714571|OG005|Outcome|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
10931023|NCT00714571|EG000|Reported Event|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
10931024|NCT00714571|EG001|Reported Event|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
10931025|NCT00714571|EG002|Reported Event|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
10931026|NCT00714571|EG003|Reported Event|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
10931027|NCT00714571|EG004|Reported Event|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
10931028|NCT00714571|EG005|Reported Event|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
10931029|NCT00714688|BG000|Baseline|Placebo|2 tablets placebo once daily for 13 weeks
10931030|NCT00714688|BG001|Baseline|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
10931031|NCT00714688|BG002|Baseline|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
10931032|NCT00714688|BG003|Baseline|Total|Total of all reporting groups
10931033|NCT00714688|FG000|Participant Flow|Placebo|2 tablets placebo once daily for 13 weeks
10931034|NCT00714688|FG001|Participant Flow|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
10931035|NCT00714688|FG002|Participant Flow|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
10931036|NCT00714688|OG000|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
10931037|NCT00714688|OG001|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
10931038|NCT00714688|OG002|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
10931039|NCT00714688|EG000|Reported Event|Placebo|2 tablets placebo once daily for 13 weeks
10931040|NCT00714688|EG001|Reported Event|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
10931041|NCT00714688|EG002|Reported Event|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
10931042|NCT00714714|BG000|Baseline|Combined Arms|All subjects received treatment with both gels in a split-face model
10931043|NCT00714714|FG000|Participant Flow|Combined Arms|All subjects received treatment with both gels in a split-face model
10931044|NCT00714714|OG000|Outcome|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
10931045|NCT00714714|OG001|Outcome|Tretinoin|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
10931046|NCT00714714|EG000|Reported Event|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
10931047|NCT00714714|EG001|Reported Event|Tretinion|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
10931048|NCT00714753|BG000|Baseline|Arm 1 (HDR ± EBRT)|Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
10931049|NCT00714753|FG000|Participant Flow|Arm 1 (HDR ± EBRT)|Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
10931050|NCT00714753|OG000|Outcome|Arm 1 (HDR ± EBRT)|Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
10931051|NCT00714753|EG000|Reported Event|Arm 1 (HDR ± EBRT)|Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
10931052|NCT00714792|BG000|Baseline|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
10931053|NCT00714792|BG001|Baseline|Control Subjects|Control subjects
10931054|NCT00714792|BG002|Baseline|Total|Total of all reporting groups
10931055|NCT00714792|FG000|Participant Flow|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
10931056|NCT00714792|FG001|Participant Flow|Control Subjects|Control subjects
10931057|NCT00714792|OG000|Outcome|Overactive Bladder Subjects|
10931058|NCT00714792|OG001|Outcome|Control Subjects|
10931059|NCT00714792|EG000|Reported Event|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
10931060|NCT00714792|EG001|Reported Event|Control Subjects|Control subjects
10931061|NCT00714870|BG000|Baseline|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
10931062|NCT00714870|BG001|Baseline|Control Group|control group: this group will not attend the nutrition and exercise program
10931063|NCT00714870|BG002|Baseline|Total|Total of all reporting groups
10931064|NCT00714870|FG000|Participant Flow|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
11377047|NCT00346164|FG002|Participant Flow|Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
10931065|NCT00714870|FG001|Participant Flow|Control Group: Standard of Care at Pediatrician's Office|control group: this group will not attend the nutrition and exercise program
10931066|NCT00714870|OG000|Outcome|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
10931067|NCT00714870|OG001|Outcome|Control|Control group received the standard of care at pediatrician's office
10931068|NCT00714870|EG000|Reported Event|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
10931069|NCT00714870|EG001|Reported Event|Control|
10931070|NCT00715026|BG000|Baseline|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
10931071|NCT00715026|FG000|Participant Flow|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
10931072|NCT00715026|OG000|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
10931073|NCT00715026|EG000|Reported Event|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
10931074|NCT00715078|BG000|Baseline|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931075|NCT00715078|BG001|Baseline|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931076|NCT00715078|BG002|Baseline|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931077|NCT00715078|BG003|Baseline|Total|Total of all reporting groups
10931078|NCT00715078|FG000|Participant Flow|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931079|NCT00715078|FG001|Participant Flow|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931080|NCT00715078|FG002|Participant Flow|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931081|NCT00715078|OG000|Outcome|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931082|NCT00715078|OG001|Outcome|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931083|NCT00715078|OG002|Outcome|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10931084|NCT00715078|EG000|Reported Event|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL
10931085|NCT00715078|EG001|Reported Event|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
10931086|NCT00715078|EG002|Reported Event|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
10931087|NCT00715104|BG000|Baseline|Sipuleucel-T With Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
10931088|NCT00715104|BG001|Baseline|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
10931089|NCT00715104|BG002|Baseline|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase(received no further sipuleucel-T treatment).
10931090|NCT00715104|BG003|Baseline|Total|Total of all reporting groups
10931091|NCT00715104|FG000|Participant Flow|Sipuleucel-T With Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
10931092|NCT00715104|FG001|Participant Flow|Sipuleucel-T Without Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
10931093|NCT00715104|FG002|Participant Flow|Sipuleucel-T Without Randomization to Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
10931094|NCT00715104|OG000|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
10931095|NCT00715104|OG001|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
10931096|NCT00715104|OG002|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
10931097|NCT00715104|OG003|Outcome|Post-RP Tumor Interface|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
10931098|NCT00715104|OG003|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
10931099|NCT00715104|OG000|Outcome|Baseline|ELISPOT for PA2024 at baseline
10931100|NCT00715104|OG001|Outcome|Pre-RP Visit|ELISPOT for PA2024 at Pre-RP Visit
10931101|NCT00715104|OG002|Outcome|6 Weeks Post-RP|ELISPOT for PA2024 at 6 Weeks post-RP
10931102|NCT00715104|OG003|Outcome|12 Weeks Post-RP|ELISPOT for PA2024 at 12 Weeks post-RP
10931103|NCT00715104|OG000|Outcome|Baseline|ELISPOT for PAP at baseline
10931104|NCT00715104|OG001|Outcome|Pre-RP Visit|ELISPOT for PAP at pre-RP visit
10931105|NCT00715104|OG002|Outcome|6 Weeks Post-RP|ELISPOT for PAP at 6 Weeks post-RP
10931106|NCT00715104|OG003|Outcome|12 Weeks Post-RP|ELISPOT for PAP at 12 Weeks post-RP
10931107|NCT00715104|OG000|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
10931108|NCT00715104|OG001|Outcome|24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
10931109|NCT00715104|OG002|Outcome|48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
10931110|NCT00715104|OG003|Outcome|72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
10931111|NCT00715104|OG000|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
10931112|NCT00715104|OG001|Outcome|24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
10931113|NCT00715104|OG002|Outcome|48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
10931114|NCT00715104|OG003|Outcome|72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
10931115|NCT00715104|OG000|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
10931116|NCT00715104|OG001|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
10931117|NCT00715104|OG002|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
10931118|NCT00715104|OG003|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to no booster
10931119|NCT00715104|OG004|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
10931120|NCT00715104|OG005|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
10931121|NCT00715104|OG006|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
10931122|NCT00715104|OG007|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
10931123|NCT00715104|OG000|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
10931124|NCT00715104|OG001|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
10931125|NCT00715104|OG002|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
10931126|NCT00715104|OG003|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to no booster
10931127|NCT00715104|OG004|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
10931128|NCT00715104|OG005|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to no booster
10931129|NCT00715104|OG006|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
10931130|NCT00715104|OG007|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to no booster
10931131|NCT00715104|EG000|Reported Event|Sipuleucel-T With Booster|Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP.
10931132|NCT00715104|EG001|Reported Event|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
10931133|NCT00715104|EG002|Reported Event|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
10931134|NCT00715117|BG000|Baseline|A: Placebo Control Group|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug for the last 8 weeks
10931135|NCT00715117|BG001|Baseline|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 16 weeks
10931136|NCT00715117|BG002|Baseline|Total|Total of all reporting groups
10931137|NCT00715117|FG000|Participant Flow|A: Placebo Then Naltrexone|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug naltrexone for the last 8 weeks
10931138|NCT00715117|FG001|Participant Flow|B: Naltrexone Then Naltrexone|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 weeks followed by the same treatment for an additional 8 weeks
10931139|NCT00715117|OG000|Outcome|All Participants Pretreament|All participants prior to receiving placebo or naltrexone at week 0
10931140|NCT00715117|OG001|Outcome|Placebo|Patients were treated with a placebo (sugar pill)for 8 weeks.
10931141|NCT00715117|OG002|Outcome|Naltrexone|Includes all Naltrexone treated participants 8 weeks of treatment.
10931142|NCT00715117|OG000|Outcome|Baseline|Quality of life values in all subjects at baseline before receiving placebo or naltrexone.
10931143|NCT00715117|OG001|Outcome|Week 16|Quality of life survey values in all subjects determined at week 16 after all 12 participants had received naltrexone for either 8 or 16 weeks.
10931144|NCT00715117|OG000|Outcome|Placebo|These subjects received placebo for 8 weeks by mouth daily.
10931145|NCT00715117|OG001|Outcome|Naltrexone|These subjects were treated with naltrexone at a dose 0.1 mg/kg not to exceed 4.5 mg po daily for either 8 or 16 weeks.
10931146|NCT00715117|EG000|Reported Event|A: Placebo Control Group|Subjects will receive placebo for 8weeks
10931147|NCT00715117|EG001|Reported Event|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 or 16 weeks
10931148|NCT00715208|BG000|Baseline|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
10931149|NCT00715208|BG001|Baseline|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
10931150|NCT00715208|BG002|Baseline|Total|Total of all reporting groups
10931151|NCT00715208|FG000|Participant Flow|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
10931152|NCT00715208|FG001|Participant Flow|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
10931153|NCT00715208|OG000|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
10931154|NCT00715208|OG001|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
10931155|NCT00715208|EG000|Reported Event|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
10931156|NCT00715208|EG001|Reported Event|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
10931157|NCT00715299|BG000|Baseline|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
10931158|NCT00715299|FG000|Participant Flow|Total Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
10931159|NCT00715299|OG000|Outcome|Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.~18 responded with a walking speed greater than 0.16 m/s, while 9 has a change < 0.16 m/s."
10931160|NCT00715299|EG000|Reported Event|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
10931161|NCT00715390|BG000|Baseline|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
10931162|NCT00715390|FG000|Participant Flow|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
10931163|NCT00715390|OG000|Outcome|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
10931164|NCT00715390|EG000|Reported Event|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
10931165|NCT00715403|BG000|Baseline|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
10931166|NCT00715403|BG001|Baseline|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
10931167|NCT00715403|BG002|Baseline|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
10931168|NCT00715403|BG003|Baseline|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
10931169|NCT00715403|BG004|Baseline|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
10931170|NCT00715403|BG005|Baseline|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
10931171|NCT00715403|BG006|Baseline|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
10931172|NCT00715403|BG007|Baseline|Total|Total of all reporting groups
10931173|NCT00715403|FG000|Participant Flow|50mg QD|Patients were treated with 50 mg Nintedanib once daily (QD) in the morning.
10931174|NCT00715403|FG001|Participant Flow|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
10931175|NCT00715403|FG002|Participant Flow|100mg BID|Patients were treated with 100 mg Nintedanib twice daily (BID).
10931176|NCT00715403|FG003|Participant Flow|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
10931177|NCT00715403|FG004|Participant Flow|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
10931178|NCT00715403|FG005|Participant Flow|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
10931179|NCT00715403|FG006|Participant Flow|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
10931180|NCT00715403|OG000|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
10931181|NCT00715403|OG001|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
10931182|NCT00715403|OG002|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
10931183|NCT00715403|OG003|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
10931184|NCT00715403|OG004|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
10931185|NCT00715403|OG005|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
10931186|NCT00715403|OG006|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
10931187|NCT00715403|EG000|Reported Event|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
10931188|NCT00715403|EG001|Reported Event|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
10931189|NCT00715403|EG002|Reported Event|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
10931190|NCT00715403|EG003|Reported Event|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
10931191|NCT00715403|EG004|Reported Event|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
10931192|NCT00715403|EG005|Reported Event|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
10931193|NCT00715403|EG006|Reported Event|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
10931194|NCT00715429|BG000|Baseline|Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks|"Vitamin D arm~vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks."
10931195|NCT00715429|BG001|Baseline|Placebo x 10d, + Placebo Weekly 7 Wks|"placebo~placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks."
10931196|NCT00715429|BG002|Baseline|Total|Total of all reporting groups
10931197|NCT00715429|FG000|Participant Flow|Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks|"Vitamin D arm~vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks."
10931198|NCT00715429|FG001|Participant Flow|Placebo x 10d, + Placebo Weekly 7 Wks|"placebo~placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks."
10931199|NCT00715429|OG000|Outcome|Vitamin D|"Vitamin D~vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks."
10931200|NCT00715429|OG001|Outcome|Placebo|"Placebo~placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks."
10931201|NCT00715429|EG000|Reported Event|Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks|"Vitamin D arm~vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks."
10931202|NCT00715429|EG001|Reported Event|Placebo x 10d, + Placebo Weekly 7 Wks|"placebo~placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks."
10931203|NCT00715520|BG000|Baseline|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
10931204|NCT00715520|BG001|Baseline|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
10931205|NCT00715520|BG002|Baseline|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
11175775|NCT02031458|OG002|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
11175776|NCT02031458|OG003|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
11175777|NCT02031458|OG000|Outcome|Pharmacokinetic Evaluable Population|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
11175778|NCT02031458|EG000|Reported Event|Cohort 1: First Line Atezolizumab|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
11175779|NCT02031458|EG001|Reported Event|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in Eastern Cooperative Oncology Group (ECOG) performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
10931206|NCT00715520|BG003|Baseline|Total|Total of all reporting groups
10931207|NCT00715520|FG000|Participant Flow|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
10931208|NCT00715520|FG001|Participant Flow|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
10931209|NCT00715520|FG002|Participant Flow|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
10931210|NCT00715520|OG000|Outcome|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
10931211|NCT00715520|OG000|Outcome|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
11175780|NCT02031458|EG002|Reported Event|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
10931212|NCT00715520|OG000|Outcome|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
10931213|NCT00715520|EG000|Reported Event|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
10931214|NCT00715520|EG001|Reported Event|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
10931215|NCT00715520|EG002|Reported Event|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
10931216|NCT00715559|BG000|Baseline|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
10931217|NCT00715559|FG000|Participant Flow|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
10931218|NCT00715559|OG000|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
10931219|NCT00715559|EG000|Reported Event|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
10931220|NCT00715624|BG000|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10931221|NCT00715624|BG001|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10931222|NCT00715624|BG002|Baseline|Total|Total of all reporting groups
10931223|NCT00715624|FG000|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10931224|NCT00715624|FG001|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
11175781|NCT02031471|BG000|Baseline|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
11175782|NCT02031471|FG000|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. Participants entered 8 weeks of follow-up either at the end of the 24-week open-label core study or after completion of the LTE. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
11175783|NCT02031471|OG000|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
11175784|NCT02031471|EG000|Reported Event|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
11175785|NCT02031536|BG000|Baseline|Arm A (Everolimus)|"Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~everolimus: Given PO"
11175786|NCT02031536|BG001|Baseline|Arm B (Placebo)|"Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~placebo: Given PO"
11175787|NCT02031536|BG002|Baseline|Total|Total of all reporting groups
11175788|NCT02031536|FG000|Participant Flow|Arm A (Everolimus)|"Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~everolimus: Given PO"
11175789|NCT02031536|FG001|Participant Flow|Arm B (Placebo)|"Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~placebo: Given PO"
11175790|NCT02031536|OG000|Outcome|Arm A (Everolimus)|"Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~everolimus: Given PO"
11175791|NCT02031536|OG001|Outcome|Arm B (Placebo)|"Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~placebo: Given PO"
11175792|NCT02031536|EG000|Reported Event|Arm A (Everolimus)|"Patients receive everolimus PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~everolimus: Given PO"
11175793|NCT02031536|EG001|Reported Event|Arm B (Placebo)|"Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~placebo: Given PO"
11175794|NCT02031627|BG000|Baseline|Group A|12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
11175795|NCT02031627|BG001|Baseline|Group B|5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
11175796|NCT02031627|BG002|Baseline|Group C|5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
10931225|NCT00715624|OG000|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
10931226|NCT00715624|OG001|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
10931227|NCT00715624|EG000|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
10931228|NCT00715624|EG001|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
11175797|NCT02031627|BG003|Baseline|Total|Total of all reporting groups
11175798|NCT02031627|FG000|Participant Flow|Group A|12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
11175799|NCT02031627|FG001|Participant Flow|Group B|5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
11175800|NCT02031627|FG002|Participant Flow|Group C|5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
11175801|NCT02031627|OG000|Outcome|Group A|12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
11175802|NCT02031627|OG001|Outcome|Group B|5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
11175803|NCT02031627|OG002|Outcome|Group C|5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
11175804|NCT02031627|EG000|Reported Event|Group A|12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
11175805|NCT02031627|EG001|Reported Event|Group B|5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
11175806|NCT02031627|EG002|Reported Event|Group C|5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
11175807|NCT02031640|BG000|Baseline|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175808|NCT02031640|BG001|Baseline|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
10931229|NCT00715650|BG000|Baseline|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
10931230|NCT00715650|BG001|Baseline|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
10931231|NCT00715650|BG002|Baseline|Total|Total of all reporting groups
10931232|NCT00715650|FG000|Participant Flow|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
11175809|NCT02031640|BG002|Baseline|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175810|NCT02031640|BG003|Baseline|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175811|NCT02031640|BG004|Baseline|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175812|NCT02031640|BG005|Baseline|Total|Total of all reporting groups
11175813|NCT02031640|FG000|Participant Flow|Consented Patients - Standard ICS and Placebo|"Consented patients were placed on a standard inhaled corticosteroids (ICS) of fluticasone propionate through the Screening and Run-In Periods. The assigned total daily dose was 440 mcg/day or 880 mcg/day dependent upon prestudy asthma treatment.~In addition to standard ICS, participants were provided with single-blind placebo BAI and single-blind placebo MDI device for twice-daily use during the Run-In period.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms"
10931233|NCT00715650|FG001|Participant Flow|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
11175814|NCT02031640|FG001|Participant Flow|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
10931234|NCT00715650|OG000|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
10931235|NCT00715650|OG001|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
10931236|NCT00715650|EG000|Reported Event|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
10931237|NCT00715650|EG001|Reported Event|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
10931238|NCT00715676|BG000|Baseline|Placebo|Placebo soft gel capsules, oral, once daily
10931239|NCT00715676|BG001|Baseline|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
10931240|NCT00715676|BG002|Baseline|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
10931241|NCT00715676|BG003|Baseline|Total|Total of all reporting groups
10931242|NCT00715676|FG000|Participant Flow|Placebo|Placebo soft gel capsules, oral, once daily
10931243|NCT00715676|FG001|Participant Flow|220 ng of Vitamin D Analog (DP001)|220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3.
10931244|NCT00715676|FG002|Participant Flow|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
10931245|NCT00715676|OG000|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
10931246|NCT00715676|OG001|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
10931247|NCT00715676|OG002|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
10931248|NCT00715676|EG000|Reported Event|Placebo|Placebo soft gel capsules, oral, once daily
10931249|NCT00715676|EG001|Reported Event|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
10931250|NCT00715676|EG002|Reported Event|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
10931251|NCT00715728|BG000|Baseline|Bair Hugger Forced Air System|Patients were warmed with the Bair Hugger forced air system during surgery.
11175815|NCT02031640|FG002|Participant Flow|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
11175816|NCT02031640|FG003|Participant Flow|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
11175817|NCT02031640|FG004|Participant Flow|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
11175818|NCT02031640|FG005|Participant Flow|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
11175819|NCT02031640|OG000|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175820|NCT02031640|OG001|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175821|NCT02031640|OG002|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175822|NCT02031640|OG003|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175823|NCT02031640|OG004|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175824|NCT02031640|OG000|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175825|NCT02031640|OG002|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175826|NCT02031640|OG003|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175827|NCT02031640|OG004|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175828|NCT02031640|OG001|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175829|NCT02031640|OG000|Outcome|Placebo BAI or MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
11175830|NCT02031640|EG000|Reported Event|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
11175831|NCT02031640|EG001|Reported Event|BAI 640 mcg/Day|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
11175832|NCT02031640|EG002|Reported Event|MDI 320 mcg/Day|Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. Placebo BAI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
11175833|NCT02031640|EG003|Reported Event|MDI 640 mcg/Day|Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. Placebo BAI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
11175834|NCT02031640|EG004|Reported Event|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
11175835|NCT02031640|EG005|Reported Event|Run-in Period Experience for Randomized Participants|Experience of randomized participants during the Run-In Period when they were administered standard ICS (fluticasone propionate) as well as single-blind placebo BAI and single-blind placebo MDI devices for twice-daily use.
11175836|NCT02031679|BG000|Baseline|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
11175837|NCT02031679|BG001|Baseline|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
11175838|NCT02031679|BG002|Baseline|Total|Total of all reporting groups
11175839|NCT02031679|FG000|Participant Flow|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
11175840|NCT02031679|FG001|Participant Flow|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
11175841|NCT02031679|OG000|Outcome|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
11175842|NCT02031679|OG001|Outcome|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
11175843|NCT02031679|EG000|Reported Event|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
11175844|NCT02031679|EG001|Reported Event|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
11175845|NCT02031770|BG000|Baseline|Study Participants|"Patients will start with sodium bicarbonate treatment then switch to control (no treatment)~Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.~Control: subjects will receive no treatment"
11175846|NCT02031770|FG000|Participant Flow|A: Treatment/Control|"Patients will start with sodium bicarbonate treatment then switch to control (no treatment)~Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.~Control: subjects will receive no treatment"
10931252|NCT00715728|BG001|Baseline|Hot Dog Resistive Heating System|Patients were warmed with the Hot Dog resistive heating system during surgery.
11175847|NCT02031770|FG001|Participant Flow|B: Control/Treatment|"Patients will start with control (no treatment) then switch to sodium bicarbonate treatment~Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.~Control: subjects will receive no treatment"
11175848|NCT02031770|OG000|Outcome|Treatment|
11175849|NCT02031770|OG001|Outcome|Control|
11175850|NCT02031770|EG000|Reported Event|Treatment|
10931253|NCT00715728|BG002|Baseline|Total|Total of all reporting groups
11175851|NCT02031770|EG001|Reported Event|Control|
11175852|NCT02032173|BG000|Baseline|Ranibizumab|Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
11175853|NCT02032173|FG000|Participant Flow|Ranibizumab|Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
11175854|NCT02032173|OG000|Outcome|Ranibizumab|Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
11175855|NCT02032173|EG000|Reported Event|Ranibizumab|Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
11175856|NCT02032212|BG000|Baseline|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
11175857|NCT02032212|BG001|Baseline|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the Nicotine inhalator on Day 4.
11175858|NCT02032212|BG002|Baseline|Sequence 3|Subjects in this arm used the Nicotine inhalator on Day 1 and the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
11175859|NCT02032212|BG003|Baseline|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the Nicotine inhalator on Day 2, the flavoured EVP on Day 3, the unflavoured EVP on Day 4.
11175860|NCT02032212|BG004|Baseline|Total|Total of all reporting groups
11175861|NCT02032212|FG000|Participant Flow|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
11175862|NCT02032212|FG001|Participant Flow|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
10931254|NCT00715728|FG000|Participant Flow|Intra-operative Rewarming With Bair Hugger Heating|Intra-operative rewarming with Bair Hugger heating system
10931255|NCT00715728|FG001|Participant Flow|Intraoperative Rewarming With Hot Dog Resistive Heating|Intraoperative rewarming with Hot Dog resistive heating system
10931256|NCT00715728|OG000|Outcome|Intra-operative Rewarming With Hot Dog|Intraoperative warming with Bair Hugger forced air system
10931257|NCT00715728|OG001|Outcome|Intra-operative Rewarming With Forced-air Heating|Intraoperative warming with forced-air heating system
10931258|NCT00715728|OG000|Outcome|Intraoperative Warming With Bair Hugger Forced Air System|Intraoperative temperature warming with Bair Hugger forced air system
10931259|NCT00715728|OG001|Outcome|Intraoperative Warming With Hot Dog Resistive Heating System|Intraoperative temperature warming with Hot Dog resistive heating system
10931260|NCT00715728|EG000|Reported Event|Bair Hugger Forced Air System|Patients were warmed with the Bair Hugger forced air system during surgery.
10931261|NCT00715728|EG001|Reported Event|Hot Dog Resistive Heating System|Patients were warmed with the Hot Dog resistive heating system during surgery.
10931262|NCT00715741|BG000|Baseline|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
10931263|NCT00715741|BG001|Baseline|Fi02 0.3 Without PEEP|30% oxygen without PEEP
10931264|NCT00715741|BG002|Baseline|Fi02 0.9 With PEEP|90% oxygen plus PEEP
10931265|NCT00715741|BG003|Baseline|Fi02 0.9 Without PEEP|90% oxygen without PEEP
10931266|NCT00715741|BG004|Baseline|Total|Total of all reporting groups
10931267|NCT00715741|FG000|Participant Flow|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
10931268|NCT00715741|FG001|Participant Flow|Fi02 0.3 Without PEEP|30% oxygen without PEEP
10931269|NCT00715741|FG002|Participant Flow|Fi02 0.9 With PEEP|90% oxygen plus PEEP
10931270|NCT00715741|FG003|Participant Flow|Fi02 0.9 Without PEEP|90% oxygen without PEEP
10931271|NCT00715741|OG000|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
10931272|NCT00715741|OG001|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
10931273|NCT00715741|OG002|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
10931274|NCT00715741|OG003|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
10931275|NCT00715741|EG000|Reported Event|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
10931276|NCT00715741|EG001|Reported Event|Fi02 0.3 Without PEEP|30% oxygen without PEEP
10931277|NCT00715741|EG002|Reported Event|Fi02 0.9 With PEEP|90% oxygen plus PEEP
10931278|NCT00715741|EG003|Reported Event|Fi02 0.9 Without PEEP|90% oxygen without PEEP
10931279|NCT00715754|BG000|Baseline|Infants|
10931280|NCT00715754|FG000|Participant Flow|All Infants|One group comprised all infants evaluated.
10931281|NCT00715754|OG000|Outcome|Newborn Infants|Newborn Infants
10931282|NCT00715754|EG000|Reported Event|All Infants|One group comprised all infants evaluated.
10931283|NCT00715793|BG000|Baseline|All Study Participants DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy, or, have progressed despite prior therapies, who were treated with DAC 0.15 mg/kg intravenously daily × 5 days/week for 2 weeks + TMZ orally 75 mg/m^2 qd for weeks 2-5 of a 6-week cycle).
10931284|NCT00715793|FG000|Participant Flow|DAC (Decitabine) 0.075 mg/kg + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with DAC 0.075 mg/kg intravenously daily × 5 days/week for 2 weeks, TMZ orally 75 mg/m^2 qd for weeks 2-5 of a 6-week cycle.
10931285|NCT00715793|FG001|Participant Flow|DAC (Decitabine) 0.15 mg/kg + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with DAC 0.15 mg/kg intravenously daily × 5 days/week for 2 weeks, TMZ orally 75 mg/m^2 qd for weeks 2-5 of a 6-week cycle.
10931286|NCT00715793|OG000|Outcome|Dose Level 1:DAC (Decitabine) 0.075 mg/kg + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with DAC 0.075 mg/kg intravenously daily × 5 days/week for 2 weeks, TMZ orally 75 mg/m^2 qd for weeks 2-5 of a 6-week cycle.
10931287|NCT00715793|OG001|Outcome|Dose Level 2:DAC (Decitabine) 0.15 mg/kg + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with DAC 0.15 mg/kg intravenously daily × 5 days/week for 2 weeks, TMZ orally 75 mg/m^2 qd for weeks 2-5 of a 6-week cycle.
10931288|NCT00715793|OG000|Outcome|DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with Intravenous DAC of 0.15 mg/kg daily for 5 days a week for the first 2 weeks of a 6-week cycle who received TMZ orally at 75 mg/m^2 daily for 4 weeks (weeks 2-5) of a 6-week cycle.
10931289|NCT00715793|OG000|Outcome|Single Arm|"Decitabine: In Part I patients will be treated on a standard 3+3 phase I dose-escalation design starting at 0.075 mg/kg until a decitabine dose level of 0.15 mg/kg is reached, or, in case unacceptable toxicities are observed, at the maximum tolerated dose (Phase II recommended dose). Decitabine will be administered at the specified dose level, intravenously, daily 5 days a week for the first 2 weeks of a 6-week cycle.~Temozolomide: Temozolomide is available in 25 mg and 100 mg tablets that will be administered orally; doses will be rounded to the nearest 25 mg. Temozolomide will be administered orally at 75 mg/m2 daily for 4 weeks starting on week 2 of a 6-week cycle.~biopsy: Fine needle aspirates (FNA) and/or core biopsies of tumor samples will be obtained from consenting patients with accessible, evaluable disease, on days 1, 8, 15, and 29 of the first cycle and when patients go off study. Biopsies are optional in Phase I and required for all consenting subjects in Phase II."
10931290|NCT00715793|EG000|Reported Event|DAC (Decitabine) + TMZ (Temozolomide)|Comprehensive listing of adverse events are presented in total (includes events from both Phase 1 and and Phase 2 of study).
10931291|NCT00715884|BG000|Baseline|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
10931292|NCT00715884|BG001|Baseline|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
10931293|NCT00715884|BG002|Baseline|Total|Total of all reporting groups
10931294|NCT00715884|FG000|Participant Flow|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
10931295|NCT00715884|FG001|Participant Flow|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
10931296|NCT00715884|OG000|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
10931297|NCT00715884|OG001|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
10931298|NCT00715884|EG000|Reported Event|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
10931299|NCT00715884|EG001|Reported Event|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
10931300|NCT00715910|BG000|Baseline|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
10931301|NCT00715910|BG001|Baseline|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
10931302|NCT00715910|BG002|Baseline|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
10931303|NCT00715910|BG003|Baseline|Nimenrix naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931304|NCT00715910|BG004|Baseline|Total|Total of all reporting groups
10931305|NCT00715910|FG000|Participant Flow|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
10931306|NCT00715910|FG001|Participant Flow|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
10931307|NCT00715910|FG002|Participant Flow|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
10931308|NCT00715910|FG003|Participant Flow|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931309|NCT00715910|FG004|Participant Flow|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931310|NCT00715910|FG005|Participant Flow|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931311|NCT00715910|OG000|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
10931312|NCT00715910|OG001|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
10931313|NCT00715910|OG002|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
10931314|NCT00715910|OG000|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931315|NCT00715910|OG001|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931316|NCT00715910|OG002|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5
10931317|NCT00715910|OG002|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931318|NCT00715910|OG002|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931319|NCT00715910|EG000|Reported Event|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
10931320|NCT00715910|EG001|Reported Event|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
10931321|NCT00715910|EG002|Reported Event|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
10931322|NCT00715910|EG003|Reported Event|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931323|NCT00715910|EG004|Reported Event|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
11175863|NCT02032212|FG002|Participant Flow|Sequence 3|Subjects in this arm used the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
11175864|NCT02032212|FG003|Participant Flow|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
11175865|NCT02032212|OG000|Outcome|EVP Unflavoured|Unflavoured e-vapour product
11175866|NCT02032212|OG001|Outcome|EVP Flavoured|Flavoured e-vapour product
11175867|NCT02032212|OG002|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
10931324|NCT00715910|EG005|Reported Event|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
10931325|NCT00715949|BG000|Baseline|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
10931326|NCT00715949|FG000|Participant Flow|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury participating in computerized neurocognitive testing
10931327|NCT00715949|OG000|Outcome|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
10931328|NCT00715949|EG000|Reported Event|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
10931329|NCT00715962|BG000|Baseline|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
10931330|NCT00715962|BG001|Baseline|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
10931331|NCT00715962|BG002|Baseline|Total|Total of all reporting groups
10931332|NCT00715962|FG000|Participant Flow|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
10931333|NCT00715962|FG001|Participant Flow|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
10931334|NCT00715962|OG000|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus a behavioral intervention that encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
10931335|NCT00715962|OG001|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
10931336|NCT00715962|OG000|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
10931337|NCT00715962|EG000|Reported Event|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
10931338|NCT00715962|EG001|Reported Event|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
10931339|NCT00716079|BG000|Baseline|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
10931340|NCT00716079|BG001|Baseline|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
10931341|NCT00716079|BG002|Baseline|Total|Total of all reporting groups
10931342|NCT00716079|FG000|Participant Flow|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
10931343|NCT00716079|FG001|Participant Flow|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
10931344|NCT00716079|OG000|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
10931345|NCT00716079|OG001|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
10931346|NCT00716079|EG000|Reported Event|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
10931347|NCT00716079|EG001|Reported Event|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
10931348|NCT00716092|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
10931349|NCT00716092|BG001|Baseline|BI1356|Patients randomized to receive treatment with BI1356 5 mg
10931350|NCT00716092|BG002|Baseline|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
11175868|NCT02032212|OG003|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
10931351|NCT00716092|BG003|Baseline|Total|Total of all reporting groups
10931352|NCT00716092|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
10931353|NCT00716092|FG001|Participant Flow|BI1356|Patients randomized to receive treatment with BI1356 5 mg
10931354|NCT00716092|FG002|Participant Flow|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
10931355|NCT00716092|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
10931356|NCT00716092|OG001|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
10931357|NCT00716092|OG002|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
10931358|NCT00716092|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
10931359|NCT00716092|EG001|Reported Event|BI1356|Patients randomized to receive treatment with BI1356 5 mg
10931360|NCT00716092|EG002|Reported Event|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
11175869|NCT02032212|EG000|Reported Event|EVP Unflavoured|Unflavoured e-vapour product
11175870|NCT02032212|EG001|Reported Event|EVP Flavoured|Flavoured e-vapour product
11175871|NCT02032212|EG002|Reported Event|Nicotine Inhalator|Nicotine inhalator 15mg
11175872|NCT02032212|EG003|Reported Event|Conventional Cigarette|Conventional cigarette (commercially available)
10931361|NCT00716144|BG000|Baseline|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931362|NCT00716144|BG001|Baseline|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931363|NCT00716144|BG002|Baseline|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931364|NCT00716144|BG003|Baseline|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931365|NCT00716144|BG004|Baseline|Total|Total of all reporting groups
10931366|NCT00716144|FG000|Participant Flow|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931367|NCT00716144|FG001|Participant Flow|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 milligram (mg) orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931368|NCT00716144|FG002|Participant Flow|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931369|NCT00716144|FG003|Participant Flow|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931370|NCT00716144|OG000|Outcome|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931371|NCT00716144|OG001|Outcome|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931372|NCT00716144|OG002|Outcome|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931373|NCT00716144|OG003|Outcome|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931374|NCT00716144|EG000|Reported Event|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931375|NCT00716144|EG001|Reported Event|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931376|NCT00716144|EG002|Reported Event|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931377|NCT00716144|EG003|Reported Event|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
10931378|NCT00716274|BG000|Baseline|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
10931379|NCT00716274|BG001|Baseline|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
10931380|NCT00716274|BG002|Baseline|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
10931381|NCT00716274|BG003|Baseline|Total|Total of all reporting groups
10931382|NCT00716274|FG000|Participant Flow|Atomoxetine|Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III).
10931383|NCT00716274|FG001|Participant Flow|Placebo|Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
10931384|NCT00716274|FG002|Participant Flow|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931385|NCT00716274|FG003|Participant Flow|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931386|NCT00716274|FG004|Participant Flow|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931387|NCT00716274|FG005|Participant Flow|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study.
10931388|NCT00716274|OG000|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
10931389|NCT00716274|OG001|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
10931390|NCT00716274|OG000|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
10931391|NCT00716274|OG000|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931392|NCT00716274|OG001|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931393|NCT00716274|OG002|Outcome|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931394|NCT00716274|OG002|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931395|NCT00716274|OG003|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
10931396|NCT00716274|OG004|Outcome|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931397|NCT00716274|OG000|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
10931398|NCT00716274|EG000|Reported Event|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
10931399|NCT00716274|EG001|Reported Event|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
10931400|NCT00716274|EG002|Reported Event|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931401|NCT00716274|EG003|Reported Event|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931402|NCT00716274|EG004|Reported Event|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
10931403|NCT00716417|BG000|Baseline|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931404|NCT00716417|BG001|Baseline|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931405|NCT00716417|BG002|Baseline|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931406|NCT00716417|BG003|Baseline|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931407|NCT00716417|BG004|Baseline|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931408|NCT00716417|BG005|Baseline|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931409|NCT00716417|BG006|Baseline|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931410|NCT00716417|BG007|Baseline|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931411|NCT00716417|BG008|Baseline|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931412|NCT00716417|BG009|Baseline|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931413|NCT00716417|BG010|Baseline|Total|Total of all reporting groups
10931414|NCT00716417|FG000|Participant Flow|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931415|NCT00716417|FG001|Participant Flow|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931416|NCT00716417|FG002|Participant Flow|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931417|NCT00716417|FG003|Participant Flow|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931418|NCT00716417|FG004|Participant Flow|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931419|NCT00716417|FG005|Participant Flow|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931420|NCT00716417|FG006|Participant Flow|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931421|NCT00716417|FG007|Participant Flow|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931422|NCT00716417|FG008|Participant Flow|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931423|NCT00716417|FG009|Participant Flow|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931424|NCT00716417|OG000|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931425|NCT00716417|OG001|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931426|NCT00716417|OG002|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931427|NCT00716417|OG003|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931428|NCT00716417|OG004|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931429|NCT00716417|OG005|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931430|NCT00716417|OG006|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931431|NCT00716417|OG007|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931432|NCT00716417|OG008|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931433|NCT00716417|OG009|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
11175873|NCT02032238|BG000|Baseline|Combination With Navigated Laser|"Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner~Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner~Anti-VEGF Injections: Monotherapy"
10931434|NCT00716417|OG000|Outcome|Pac + Cis + Afatinib (Regimen A)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
11175874|NCT02032238|BG001|Baseline|Monotherapy|"patients receive Anti-VEGF Monotherapy~Anti-VEGF Injections: Monotherapy"
11175875|NCT02032238|BG002|Baseline|Total|Total of all reporting groups
11175876|NCT02032238|FG000|Participant Flow|Laser Photocoagulation With Bevacizumab|Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner
10931435|NCT00716417|OG001|Outcome|5FU + Cis + Afatinib (Regimen B)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
10931436|NCT00716417|EG000|Reported Event|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931437|NCT00716417|EG001|Reported Event|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931438|NCT00716417|EG002|Reported Event|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931439|NCT00716417|EG003|Reported Event|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931440|NCT00716417|EG004|Reported Event|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931441|NCT00716417|EG005|Reported Event|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931442|NCT00716417|EG006|Reported Event|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931443|NCT00716417|EG007|Reported Event|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931444|NCT00716417|EG008|Reported Event|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931445|NCT00716417|EG009|Reported Event|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
10931446|NCT00716443|BG000|Baseline|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
10931447|NCT00716443|FG000|Participant Flow|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
10931448|NCT00716443|OG000|Outcome|Pliaglis® Cream|Pliaglis® Cream
10931449|NCT00716443|OG001|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
10931450|NCT00716443|EG000|Reported Event|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
10931451|NCT00716456|BG000|Baseline|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
10931452|NCT00716456|BG001|Baseline|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
10931453|NCT00716456|BG002|Baseline|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
10931454|NCT00716456|BG003|Baseline|Total|Total of all reporting groups
10931455|NCT00716456|FG000|Participant Flow|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
10931456|NCT00716456|FG001|Participant Flow|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
10931457|NCT00716456|FG002|Participant Flow|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
10931458|NCT00716456|OG000|Outcome|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
10931459|NCT00716456|OG001|Outcome|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
10931460|NCT00716456|OG002|Outcome|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
10931461|NCT00716456|EG000|Reported Event|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
10931462|NCT00716456|EG001|Reported Event|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
10931463|NCT00716456|EG002|Reported Event|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
10931464|NCT00716482|BG000|Baseline|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
10931465|NCT00716482|FG000|Participant Flow|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
10931466|NCT00716482|OG000|Outcome|Specificity|Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
11175877|NCT02032238|FG001|Participant Flow|Bevacizumab, no Laser Photocoagulation|patients receive Anti-VEGF injections (Bevacizumab) only
10931467|NCT00716482|OG001|Outcome|Sensitivity|Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
10931468|NCT00716482|OG000|Outcome|Very Homogeneous|The Elastography image of the lesion has a smooth and consistent color appearance throughout, or very subtle color differences relating to small changes on the color scale are observed.
10931469|NCT00716482|OG001|Outcome|Reasonably Homogeneous|"The Elastography image of the lesion has a slightly patchy appearance. The image may consist of larger (2-5mm) sub-regions within the lesion boundary that are homogenous, or the color differences between adjacent areas within the lesion are small."
10931470|NCT00716482|OG002|Outcome|Not Homogeneous|"The Elastography image of the lesion is inhomogeneous and has a mottled or patchy appearance throughout."
10931471|NCT00716482|OG000|Outcome|Overall (All Masses)|614 benign and 144 malignant masses
10931472|NCT00716482|OG000|Outcome|Overall (All Masses)|Benign and malignant lesions
10931473|NCT00716482|EG000|Reported Event|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
10931474|NCT00716586|BG000|Baseline|Topical Form of Carbonic Anhydrase Inhibitor.|"Participants 18 years or older with cystoid macular edema and retinal degeneration will be treated with Trusopt.~dorzolamide: 2% dorzolamide- 1 Gtt TID"
10931475|NCT00716586|FG000|Participant Flow|Trusopt (2 % Dorzolamide).|Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day.
10931476|NCT00716586|OG000|Outcome|Trusopt (2% Dorzolamide)|Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day
10931477|NCT00716586|OG000|Outcome|Trusopt (2% Dorzolamide)|Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide ), 1 drop three times per day.
10931478|NCT00716586|EG000|Reported Event|Topical Form of Carbonic Anhydrase Inhibitor|"Participants 18 years or older with cystoid macular edema and retinal degeneration will be treated with Trusopt.~dorzolamide: 2% dorzolamide- 1 Gtt TID"
10931479|NCT00716625|BG000|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
10931480|NCT00716625|FG000|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
10931481|NCT00716625|OG000|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
10931482|NCT00716625|OG000|Outcome|Pediatric|Participants aged ˂15 years who received sunitinib malate according to Japanese package insert
10931483|NCT00716625|OG001|Outcome|Adult|Participants aged ˃=15 years who received sunitinib malate according to Japanese package insert
10931484|NCT00716625|OG002|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
10931485|NCT00716625|OG000|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
10931486|NCT00716625|OG001|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
10931487|NCT00716625|OG000|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
10931488|NCT00716625|OG001|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
10931489|NCT00716625|OG002|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
10931490|NCT00716625|OG000|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
10931491|NCT00716625|OG001|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
10931492|NCT00716625|OG002|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
10931493|NCT00716625|OG000|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
10931494|NCT00716625|OG001|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
10931495|NCT00716625|OG002|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
10931496|NCT00716625|EG000|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
10931497|NCT00716742|BG000|Baseline|Lumigan®|bimatoprost 0.03%
10931498|NCT00716742|BG001|Baseline|Travatan®|travoprost 0.004%
10931499|NCT00716742|BG002|Baseline|Xalatan®|latanoprost 0.005%
10931500|NCT00716742|BG003|Baseline|Total|Total of all reporting groups
10931501|NCT00716742|FG000|Participant Flow|Lumigan®|bimatoprost 0.03%
10931502|NCT00716742|FG001|Participant Flow|Travatan®|travoprost 0.004%
10931503|NCT00716742|FG002|Participant Flow|Xalatan®|latanoprost 0.005%
10931504|NCT00716742|OG000|Outcome|Lumigan®|bimatoprost 0.03%
10931505|NCT00716742|OG001|Outcome|Travatan®|travoprost 0.004%
10931506|NCT00716742|OG002|Outcome|Xalatan®|latanoprost 0.005%
10931507|NCT00716742|EG000|Reported Event|Lumigan®|bimatoprost 0.03%
10931508|NCT00716742|EG001|Reported Event|Travatan®|travoprost 0.004%
10931509|NCT00716742|EG002|Reported Event|Xalatan®|latanoprost 0.005%
10931510|NCT00716820|BG000|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
10931511|NCT00716820|FG000|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
10931512|NCT00716820|OG000|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
10931513|NCT00716820|OG000|Outcome|KIT Positive|Participants with positive KIT expression who received sunitinib malate according to Japanese package insert
10931514|NCT00716820|OG001|Outcome|KIT Negative|Participants with negative KIT expression who received sunitinib malate according to Japanese package insert
10931515|NCT00716820|OG002|Outcome|Unknown|Participants with unknown KIT expression status who received sunitinib malate according to Japanese package insert
10931516|NCT00716820|OG000|Outcome|c-Kit With Mutation|Participants with c-kit mutation who received sunitinib malate according to Japanese package insert
10931517|NCT00716820|OG001|Outcome|c-Kit Without Mutation|Participants without c-kit mutation who received sunitinib malate according to Japanese package insert
10931518|NCT00716820|OG002|Outcome|Unknown|Participants with unknown c-kit mutation status who received sunitinib malate according to Japanese package insert
10931519|NCT00716820|OG000|Outcome|PDGFRα With Mutation|Participants with PDGFRα mutation who received sunitinib malate according to Japanese package insert
10931520|NCT00716820|OG001|Outcome|PDGFRα Without Mutation|Participants without PDGFRα mutation who received sunitinib malate according to Japanese package insert
10931521|NCT00716820|OG002|Outcome|Unknown|Participants with unknown PDGFRα mutation status who received sunitinib malate according to Japanese package insert
10931522|NCT00716820|OG000|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
10931523|NCT00716820|OG001|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
10931524|NCT00716820|OG002|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
10931525|NCT00716820|OG000|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
10931526|NCT00716820|OG001|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
10931527|NCT00716820|OG002|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
10931528|NCT00716820|OG000|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
10931529|NCT00716820|OG001|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
10931530|NCT00716820|OG002|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
10931531|NCT00716820|OG000|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
10931532|NCT00716820|OG001|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
10931533|NCT00716820|OG002|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
10931534|NCT00716820|EG000|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
10931535|NCT00716859|BG000|Baseline|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
10931536|NCT00716859|BG001|Baseline|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
10931537|NCT00716859|BG002|Baseline|Total|Total of all reporting groups
10931538|NCT00716859|FG000|Participant Flow|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
10931539|NCT00716859|FG001|Participant Flow|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
10931540|NCT00716859|OG000|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
10931541|NCT00716859|OG001|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
10931542|NCT00716859|EG000|Reported Event|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
10931543|NCT00716859|EG001|Reported Event|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
10931544|NCT00716963|BG000|Baseline|Screening/Baseline Participants|
10931545|NCT00716963|FG000|Participant Flow|Fluticasone/Budesonide/Placebo|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
10931546|NCT00716963|FG001|Participant Flow|Fluticasone/Placebo/Budesonide|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
10931547|NCT00716963|FG002|Participant Flow|Budesonide/Fluticasone/Placebo|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
10931548|NCT00716963|FG003|Participant Flow|Budesonide/Placebo/Fluticasone|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
10931549|NCT00716963|FG004|Participant Flow|Placebo/Fluticasone/Budesonide|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
10931550|NCT00716963|FG005|Participant Flow|Placebo/Budesonide/Fluticasone|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
10931551|NCT00716963|OG000|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
10931552|NCT00716963|OG001|Outcome|Budesonide 400mcg|
10931553|NCT00716963|OG002|Outcome|Placebo|
10931554|NCT00716963|EG000|Reported Event|Fluticasone Propionate (Flovent Diskus) 250 mcg|
10931555|NCT00716963|EG001|Reported Event|Budesonide 400mcg|
10931556|NCT00716963|EG002|Reported Event|Placebo|
10931557|NCT00716976|BG000|Baseline|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
10931558|NCT00716976|BG001|Baseline|Observation Arm|No sodium thiosulfate treatment.
10931559|NCT00716976|BG002|Baseline|Total|Total of all reporting groups
10931560|NCT00716976|FG000|Participant Flow|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
10931561|NCT00716976|FG001|Participant Flow|Observation Arm|No sodium thiosulfate treatment.
10931562|NCT00716976|OG000|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
10931563|NCT00716976|OG001|Outcome|Observation Arm|No sodium thiosulfate treatment.
10931564|NCT00716976|OG000|Outcome|STS Arm (Sodium Thiosulfate Treatment)|"Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.~sodium thiosulfate: Given IV~examination: Patients undergo audiological assessments periodically"
10931565|NCT00716976|OG001|Outcome|Observation Arm (No Sodium Thiosulfate Treatment)|"Patients do not receive sodium thiosulfate.~examination: Patients undergo audiological assessments periodically"
10931566|NCT00716976|EG000|Reported Event|STS Arm (Sodium Thiosulfate Treatment)|
10931567|NCT00716976|EG001|Reported Event|Observation Arm|
10931568|NCT00717041|BG000|Baseline|Presenting to the ED|Patients who present to the ED
10931569|NCT00717041|FG000|Participant Flow|Presenting to the ED|Patients who present to the ED
10931570|NCT00717041|OG000|Outcome|Presenting to the ED|Patients who present to the ED
10931571|NCT00717041|OG000|Outcome|Depressed in the ED|Patients who present to the ED who test positive for depression
10931572|NCT00717041|OG001|Outcome|Cognitively Impaired in the ED|Patients presenting to the ED who have cognitive impairment
10931573|NCT00717041|EG000|Reported Event|Presenting to the ED|Patients who present to the ED
10931574|NCT00717054|BG000|Baseline|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931575|NCT00717054|BG001|Baseline|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931576|NCT00717054|BG002|Baseline|Total|Total of all reporting groups
10931577|NCT00717054|FG000|Participant Flow|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931578|NCT00717054|FG001|Participant Flow|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931579|NCT00717054|OG000|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931580|NCT00717054|OG001|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931581|NCT00717054|OG001|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931582|NCT00717054|EG000|Reported Event|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931583|NCT00717054|EG001|Reported Event|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
10931584|NCT00717067|BG000|Baseline|Healthy Subjects|Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min)
10931585|NCT00717067|BG001|Baseline|Mild Renal Impairment|Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)
10931586|NCT00717067|BG002|Baseline|Moderate Renal Impairment|Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
10931587|NCT00717067|BG003|Baseline|Severe Renal Impairment|Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)
10931588|NCT00717067|BG004|Baseline|ESRD on Hemodialysis|Subjects with End Stage Renal Disease Requiring Regular Hemodialysis 3 Times a Week for at Least 6 Weeks Prior to Screening (Creatinine Clearance <30 mL/min)
10931589|NCT00717067|BG005|Baseline|Total|Total of all reporting groups
11175878|NCT02032238|OG000|Outcome|Combination With Navigated Laser|"Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner~Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner~Anti-VEGF Injections: Monotherapy"
10931590|NCT00717067|FG000|Participant Flow|Healthy Subjects|(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
10931591|NCT00717067|FG001|Participant Flow|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
10931592|NCT00717067|FG002|Participant Flow|Moderate Renal Impairment|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
10931593|NCT00717067|FG003|Participant Flow|Severe Renal Impairment|Maraviroc 300 mg single dose.
10931594|NCT00717067|FG004|Participant Flow|ESRD: Single Dose|(I) Maraviroc single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc single dose three hours prior to start of hemodialysis.
10931595|NCT00717067|OG000|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
10931596|NCT00717067|OG001|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
10931597|NCT00717067|OG002|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
10931598|NCT00717067|OG003|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
10931599|NCT00717067|OG004|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
10931600|NCT00717067|OG005|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
10931601|NCT00717067|OG006|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
10931602|NCT00717067|OG005|Outcome|ESRD|(I) Maraviroc 300 mg single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
10931603|NCT00717067|OG000|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
10931604|NCT00717067|OG001|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
11175879|NCT02032238|OG001|Outcome|Monotherapy|"patients receive Anti-VEGF Monotherapy~Anti-VEGF Injections: Monotherapy"
11175880|NCT02032238|EG000|Reported Event|Laser Photocoagulation With Bevacizumab|Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner
11175881|NCT02032238|EG001|Reported Event|Bevacizumab, no Laser Photocoagulation|patients receive Anti-VEGF injections (Bevacizumab) only
11175882|NCT02032407|BG000|Baseline|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
10931605|NCT00717067|OG002|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
10931606|NCT00717067|OG003|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
10931607|NCT00717067|OG000|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis
10931608|NCT00717067|EG000|Reported Event|Healthy Subjects|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
10931609|NCT00717067|EG001|Reported Event|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
10931610|NCT00717067|EG002|Reported Event|Moderate Renal Impairment|Maraviroc 150 milligrams (mg) every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
10931611|NCT00717067|EG003|Reported Event|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
10931612|NCT00717067|EG004|Reported Event|Severe Renal Impairment:|Maraviroc 300 mg single dose.
10931613|NCT00717067|EG005|Reported Event|ESRD: Dosing After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
10931614|NCT00717067|EG006|Reported Event|ESRD: Dosing Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
11175883|NCT02032407|FG000|Participant Flow|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
11175884|NCT02032407|OG000|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
10931615|NCT00717093|BG000|Baseline|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
10931616|NCT00717093|BG001|Baseline|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
10931617|NCT00717093|BG002|Baseline|Total|Total of all reporting groups
10931618|NCT00717093|FG000|Participant Flow|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
10931619|NCT00717093|FG001|Participant Flow|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
10931620|NCT00717093|OG000|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
10931621|NCT00717093|OG001|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
10931622|NCT00717093|EG000|Reported Event|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
10931623|NCT00717093|EG001|Reported Event|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
10931624|NCT00717197|BG000|Baseline|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
10931625|NCT00717197|FG000|Participant Flow|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
10931626|NCT00717197|OG000|Outcome|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
10931627|NCT00717197|EG000|Reported Event|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
10931628|NCT00717236|BG000|Baseline|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
10931629|NCT00717236|BG001|Baseline|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
10931630|NCT00717236|BG002|Baseline|Total|Total of all reporting groups
10931631|NCT00717236|FG000|Participant Flow|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
11175885|NCT02032407|EG000|Reported Event|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
11175886|NCT02032420|BG000|Baseline|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
11175887|NCT02032420|BG001|Baseline|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
11175888|NCT02032420|BG002|Baseline|Total|Total of all reporting groups
11175889|NCT02032420|FG000|Participant Flow|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
10931632|NCT00717236|FG001|Participant Flow|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
10931633|NCT00717236|OG000|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
10931634|NCT00717236|OG001|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
10931635|NCT00717236|OG000|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
10931636|NCT00717236|EG000|Reported Event|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
10931637|NCT00717236|EG001|Reported Event|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg certolizumab pegol (CZP) given as 1 subcutaneous injection every other week for a minimum 16 additional weeks until CZP is commercially available.
10931638|NCT00717236|EG002|Reported Event|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
10931639|NCT00717249|BG000|Baseline|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
10931640|NCT00717249|BG001|Baseline|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
10931641|NCT00717249|BG002|Baseline|Total|Total of all reporting groups
10931642|NCT00717249|FG000|Participant Flow|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
10931643|NCT00717249|FG001|Participant Flow|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
11175890|NCT02032420|FG001|Participant Flow|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
10931644|NCT00717249|OG000|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
10931645|NCT00717249|OG001|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
10931646|NCT00717249|EG000|Reported Event|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
10931647|NCT00717249|EG001|Reported Event|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
10931648|NCT00717288|BG000|Baseline|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
10931649|NCT00717288|BG001|Baseline|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
10931650|NCT00717288|BG002|Baseline|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
10931651|NCT00717288|BG003|Baseline|Total|Total of all reporting groups
11175891|NCT02032420|OG000|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
10931652|NCT00717288|FG000|Participant Flow|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
10931653|NCT00717288|FG001|Participant Flow|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
10931654|NCT00717288|FG002|Participant Flow|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
10931655|NCT00717288|OG000|Outcome|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
10931656|NCT00717288|OG001|Outcome|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
10931657|NCT00717288|OG002|Outcome|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
10931658|NCT00717288|OG000|Outcome|50% Conversion Factor|Number of subjects with a BG value <65 mg/dl
10931659|NCT00717288|OG001|Outcome|65% Conversion Factor|Number of subjects with a BG value <65 mg/dl
10931660|NCT00717288|OG002|Outcome|80% Conversion Factor|Number of subjects with a BG value <65 mg/dl
10931661|NCT00717288|OG000|Outcome|50% Conversion Factor|Number of subjects that reverted back to an insulin drip
10931662|NCT00717288|OG001|Outcome|65% Conversion Factor|Number of subjects that reverted back to an insulin drip
10931663|NCT00717288|OG002|Outcome|80% Conversion Factor|Number of subjects that reverted back to an insulin drip
10931664|NCT00717288|EG000|Reported Event|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
11175892|NCT02032420|OG001|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
11175893|NCT02032420|EG000|Reported Event|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
10931665|NCT00717288|EG001|Reported Event|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
10931666|NCT00717288|EG002|Reported Event|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
10931667|NCT00717314|BG000|Baseline|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
10931668|NCT00717314|BG001|Baseline|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
10931669|NCT00717314|BG002|Baseline|Total|Total of all reporting groups
10931670|NCT00717314|FG000|Participant Flow|Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI)|Participants received MMF capsules, 1.5 to 2.0 grams (g), orally (PO), twice daily (BID) up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50 percent (%) through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
10931671|NCT00717314|FG001|Participant Flow|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
10931672|NCT00717314|OG000|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
10931673|NCT00717314|OG001|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
10931674|NCT00717314|EG000|Reported Event|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
10931675|NCT00717314|EG001|Reported Event|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
10931676|NCT00717366|BG000|Baseline|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
10931677|NCT00717366|BG001|Baseline|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
10931678|NCT00717366|BG002|Baseline|Total|Total of all reporting groups
11175894|NCT02032420|EG001|Reported Event|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
11175895|NCT02032433|BG000|Baseline|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
11175896|NCT02032433|BG001|Baseline|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
11175897|NCT02032433|BG002|Baseline|Total|Total of all reporting groups
10931679|NCT00717366|FG000|Participant Flow|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received methoxy polyethylene glycol-epoetin beta (MIRCERA) intravenous (IV) injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-Stimulating Agent (ESA) dose (4 * previous weekly epoetin dose [international units {IU}]/250 or 4 * previous weekly darbepoetin alfa dose [micrograms {mcg}]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
10931680|NCT00717366|FG001|Participant Flow|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
10931681|NCT00717366|OG000|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
10931682|NCT00717366|OG001|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
10931683|NCT00717366|EG000|Reported Event|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
10931684|NCT00717366|EG001|Reported Event|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
10931685|NCT00717405|BG000|Baseline|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
10931686|NCT00717405|FG000|Participant Flow|Bevacizumab + Trastuzumab Chemotherapy|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 milligrams per kilogram (mg/kg) intravenous (IV) bevacizumab every 3 weeks (q3w) for 8 cycles, 4 cycles of 500 milligrams per squared-meter (mg/m^2) IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
10931687|NCT00717405|OG000|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
10963310|NCT00871403|FG001|Participant Flow|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
10931688|NCT00717405|EG000|Reported Event|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
10931689|NCT00717418|BG000|Baseline|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
10931690|NCT00717418|BG001|Baseline|Artificial Tears Alone|
10931691|NCT00717418|BG002|Baseline|Combination Treatments|
10931692|NCT00717418|BG003|Baseline|Missing Treatment Information|
10931693|NCT00717418|BG004|Baseline|Total|Total of all reporting groups
10931694|NCT00717418|FG000|Participant Flow|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
10931695|NCT00717418|FG001|Participant Flow|Artificial Tears Alone|
10931696|NCT00717418|FG002|Participant Flow|Combination Treatments|
10931697|NCT00717418|FG003|Participant Flow|Missing Treatment Information|
10931698|NCT00717418|OG000|Outcome|All Patients|
10931699|NCT00717418|EG000|Reported Event|All Patients|
10931700|NCT00717522|BG000|Baseline|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
10931701|NCT00717522|FG000|Participant Flow|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
10931702|NCT00717522|OG000|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
10931703|NCT00717522|EG000|Reported Event|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
10931704|NCT00717574|BG000|Baseline|Sevoflurane Group|"Sevoflurane based general anesthesia~Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
10931705|NCT00717574|BG001|Baseline|Propofol Group|"Propofol based general anesthesia~Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
10931706|NCT00717574|BG002|Baseline|Total|Total of all reporting groups
10931707|NCT00717574|FG000|Participant Flow|Sevoflurane Group|"Sevoflurane based general anesthesia~Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
10931708|NCT00717574|FG001|Participant Flow|Propofol Group|"Propofol based general anesthesia~Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
10931709|NCT00717574|OG000|Outcome|Sevoflurane Group|"Sevoflurane based general anesthesia~Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
10931710|NCT00717574|OG001|Outcome|Propofol Group|"Propofol based general anesthesia~Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
10931711|NCT00717574|EG000|Reported Event|Sevoflurane Group|"Sevoflurane based general anesthesia~Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
10931712|NCT00717574|EG001|Reported Event|Propofol Group|"Propofol based general anesthesia~Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
10931713|NCT00717626|BG000|Baseline|Daily Administration of Low Dose FVIII|"Low dose daily prophylaxis using FVIII products (e.g.Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS)~Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS: Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is < 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII."
10931714|NCT00717626|FG000|Participant Flow|Daily Administration of Low Dose FVIII|"Low dose daily prophylaxis using FVIII products (e.g.Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS)~Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS: Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is < 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII."
10931715|NCT00717626|OG000|Outcome|Daily Administration of Low Dose FVIII|"Low dose daily prophylaxis using FVIII products (e.g.Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS)~Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS: Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is < 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII."
10931716|NCT00717626|EG000|Reported Event|Daily Administration of Low Dose FVIII|"Low dose daily prophylaxis using FVIII products (e.g.Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS)~Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS: Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is < 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII."
10931717|NCT00717756|BG000|Baseline|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
10931718|NCT00717756|FG000|Participant Flow|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
10931719|NCT00717756|OG000|Outcome|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
10931720|NCT00717756|EG000|Reported Event|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
10931721|NCT00717769|BG000|Baseline|Placebo|Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.
11175898|NCT02032433|FG000|Participant Flow|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
10931722|NCT00717769|BG001|Baseline|SUN13834 50 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg;(2×50 mg) orally tid for 28 days.
10931723|NCT00717769|BG002|Baseline|SUN13834 200 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) orally tid for 28 days.
10931724|NCT00717769|BG003|Baseline|Total|Total of all reporting groups
10931725|NCT00717769|FG000|Participant Flow|Placebo|Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.
10931726|NCT00717769|FG001|Participant Flow|SUN13834 50 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.
10931727|NCT00717769|FG002|Participant Flow|SUN13834 200 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
10931728|NCT00717769|OG000|Outcome|Placebo|Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.
10931729|NCT00717769|OG001|Outcome|SUN13834 50 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.
10931730|NCT00717769|OG002|Outcome|SUN13834 200 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
10931731|NCT00717769|OG000|Outcome|SUN13834 50 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.
10931732|NCT00717769|OG001|Outcome|SUN13834 200 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
11175899|NCT02032433|FG001|Participant Flow|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
11175900|NCT02032433|OG000|Outcome|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
11175901|NCT02032433|OG001|Outcome|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
10931733|NCT00717769|EG000|Reported Event|Placebo|Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.
10931734|NCT00717769|EG001|Reported Event|SUN13834 50 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) tid orally 3 times a day (tid) for 28 days.
10931735|NCT00717769|EG002|Reported Event|SUN13834 200 mg Tid|Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) tid orally 3 times a day (tid) for 28 days.
10931736|NCT00717860|BG000|Baseline|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
10931737|NCT00717860|BG001|Baseline|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
10931738|NCT00717860|BG002|Baseline|Total|Total of all reporting groups
10931739|NCT00717860|FG000|Participant Flow|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
10931740|NCT00717860|FG001|Participant Flow|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
10931741|NCT00717860|OG000|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
10931742|NCT00717860|OG001|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
10931743|NCT00717860|EG000|Reported Event|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
10931744|NCT00717860|EG001|Reported Event|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
10931745|NCT00717873|BG000|Baseline|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
10931746|NCT00717873|BG001|Baseline|CPT Arm|Airway clearance provided by manual CPT
10931747|NCT00717873|BG002|Baseline|Total|Total of all reporting groups
10931748|NCT00717873|FG000|Participant Flow|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
10931749|NCT00717873|FG001|Participant Flow|CPT Arm|Airway clearance provided by manual CPT
10931750|NCT00717873|OG000|Outcome|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
10931751|NCT00717873|OG001|Outcome|CPT Arm|Airway clearance provided by manual CPT
10931752|NCT00717873|EG000|Reported Event|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
10931753|NCT00717873|EG001|Reported Event|CPT Arm|Airway clearance provided by manual CPT
10931754|NCT00717886|BG000|Baseline|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
10931755|NCT00717886|FG000|Participant Flow|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
11175902|NCT02032433|EG000|Reported Event|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
11175903|NCT02032433|EG001|Reported Event|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
11175904|NCT02032550|BG000|Baseline|Preference Based Decision Aid|"The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.~Preference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes."
11175905|NCT02032550|BG001|Baseline|Usual Care|Participants randomized into this group will have usual care from their doctors without any intervention
11175906|NCT02032550|BG002|Baseline|Total|Total of all reporting groups
11175907|NCT02032550|FG000|Participant Flow|Preference Based Decision Aid|"The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.~Preference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes."
10931756|NCT00717886|OG000|Outcome|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
10931757|NCT00717886|EG000|Reported Event|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
10931758|NCT00717912|BG000|Baseline|All Participants|Each subject received the study products in different order according to the randomization list
10931759|NCT00717912|FG000|Participant Flow|Arm 1|Classical sugar syrup/ Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup
10931760|NCT00717912|FG001|Participant Flow|Arm 2|Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup
11175908|NCT02032550|FG001|Participant Flow|Usual Care|Participants randomized into this group will have usual care from their doctors without any intervention
10931761|NCT00717912|FG002|Participant Flow|Arm 3|Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup
10931762|NCT00717912|FG003|Participant Flow|Arm 4|Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup
10931763|NCT00717912|FG004|Participant Flow|Arm 5|Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup
10931764|NCT00717912|FG005|Participant Flow|Arm 6|Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup
10931765|NCT00717912|OG000|Outcome|Classical Sugar Syrup|The subjects consumed three time this product
10931766|NCT00717912|OG001|Outcome|Experimental Sweetener Syrup|The subjects consumed three times this product
10931767|NCT00717912|OG002|Outcome|Classical Sweetener Syrup|The subjects consumed once this product
10931768|NCT00717912|OG000|Outcome|Classical Sugar Syrup|The subjects consumed three times this product
10931769|NCT00717912|EG000|Reported Event|Classical Sugar Syrup|The subjects consumed three times this product
10931770|NCT00717912|EG001|Reported Event|Experimental Sweetener Syrup|The subjects consumed three times this product
10931771|NCT00717912|EG002|Reported Event|Classical Sweetener Syrup|The subjects consumed once this product
10931772|NCT00717977|BG000|Baseline|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
10931773|NCT00717977|FG000|Participant Flow|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
10931774|NCT00717977|OG000|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
10931775|NCT00717977|EG000|Reported Event|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
10931776|NCT00718042|BG000|Baseline|ABBOTT PRISM Chagas Specificity|All subject's blood tested by the investigational Chagas screening test.
11175909|NCT02032550|OG000|Outcome|Preference Based Decision Aid|"The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.~Preference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes."
11175910|NCT02032550|OG001|Outcome|Usual Care|Participants randomized into this group will have usual care from their doctors without any intervention
10931777|NCT00718042|BG001|Baseline|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
10931778|NCT00718042|BG002|Baseline|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
10931779|NCT00718042|BG003|Baseline|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
10931780|NCT00718042|BG004|Baseline|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
10931781|NCT00718042|BG005|Baseline|Chagas Extended Evaluation|All subject's blood tested by the investigational Chagas screening test.
10931782|NCT00718042|BG006|Baseline|Total|Total of all reporting groups
10931783|NCT00718042|FG000|Participant Flow|ABBOTT PRISM Chagas Specificity|All blood donor specimens tested by the investigational Chagas screening test in design validation phase.
10931784|NCT00718042|FG001|Participant Flow|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
10931785|NCT00718042|FG002|Participant Flow|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
10931786|NCT00718042|FG003|Participant Flow|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
10931787|NCT00718042|FG004|Participant Flow|Chagas Extended Evaluation|US blood donor specimen were tested with investigational Chagas screening assay to identify repeatedly reactive specimens.
10931788|NCT00718042|FG005|Participant Flow|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
10931789|NCT00718042|OG000|Outcome|ABBOTT PRISM Chagas Specificity|Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
10931790|NCT00718042|OG000|Outcome|Reactivity T Cruzi Antibody Positive|Specimen positive for T cruzi antibody collected in South America (85) under separate specimen collection protocol and unidentified US blood donor specimens repeatedly reactive by T cruzi antibody licensed screening assay (202) were tested with investigational PRISM Chagas screening assay.
10931791|NCT00718042|OG000|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay.
10931792|NCT00718042|OG000|Outcome|PRISM Chagas Reactivity Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
10931793|NCT00718042|OG000|Outcome|ESA Chagas US Donor Specimen Testing|A total of 58 PRISM Chagas repeatedly reactive US blood donor specimens tested with both ESA Chagas and RIPA.
10931794|NCT00718042|OG000|Outcome|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
10931795|NCT00718042|OG000|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South or Central America under separate specimen collection protocols were tested with investigational with ESA Chagas.
10931796|NCT00718042|OG000|Outcome|ESA Chagas Non-US Serologically Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols.
10931797|NCT00718042|OG000|Outcome|Reactivity in Chagas Endemic Population|Specimen from Chagas endemic area in South or Central America (524) under separate specimen collection protocol were tested with investigational ESA Chagas.
10931798|NCT00718042|EG000|Reported Event|Donor Follow-up Specimen Collection|Blood donors
10931799|NCT00718081|BG000|Baseline|Sufentanil NanoTab 10 mcg|
10931800|NCT00718081|BG001|Baseline|Sufentanil NanoTab 15 mcg|
10931801|NCT00718081|BG002|Baseline|Placebo NanoTab|
10931802|NCT00718081|BG003|Baseline|Total|Total of all reporting groups
10931803|NCT00718081|FG000|Participant Flow|Sufentanil NanoTab 10 mcg|
10931804|NCT00718081|FG001|Participant Flow|Sufentanil NanoTab 15 mcg|
10931805|NCT00718081|FG002|Participant Flow|Placebo NanoTab|
10931806|NCT00718081|OG000|Outcome|Sufentanil NanoTab 10 mcg|
10931807|NCT00718081|OG001|Outcome|Sufentanil NanoTab 15 mcg|
10931808|NCT00718081|OG002|Outcome|Placebo NanoTab|
10931809|NCT00718081|EG000|Reported Event|Sufentanil NanoTab 10 mcg|
10931810|NCT00718081|EG001|Reported Event|Sufentanil NanoTab 15 mcg|
10931811|NCT00718081|EG002|Reported Event|Placebo NanoTab|
10931812|NCT00718094|BG000|Baseline|Polyphenon E Treatment|Polyphenon E®: Oral capsules
10931813|NCT00718094|BG001|Baseline|Placebo|"Oral Placebo~Placebo Oral Tablet: Oral tablet: placebo"
10931814|NCT00718094|BG002|Baseline|Total|Total of all reporting groups
10931815|NCT00718094|FG000|Participant Flow|Polyphenon Treatment|Polyphenon E®: Oral capsules for 56 days
10931816|NCT00718094|FG001|Participant Flow|Placebo|Placebo Oral Tablet: Oral tablet: placebo
10931817|NCT00718094|OG000|Outcome|Polyphenon E Treatment|Polyphenon E®: Oral capsules
10931818|NCT00718094|OG001|Outcome|Placebo|Placebo Oral Tablet: Oral tablet: placebo
10931819|NCT00718094|EG000|Reported Event|Polyphenon E Treatment|Polyphenon E®: Oral capsules
10931820|NCT00718094|EG001|Reported Event|Placebo|Placebo Oral Tablet: Oral tablet: placebo
10931821|NCT00718120|BG000|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
10931822|NCT00718120|BG001|Baseline|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
10931823|NCT00718120|BG002|Baseline|Total|Total of all reporting groups
10931824|NCT00718120|FG000|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
10931825|NCT00718120|FG001|Participant Flow|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
10931826|NCT00718120|OG000|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
10931827|NCT00718120|OG001|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
10931828|NCT00718120|EG000|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
10931829|NCT00718120|EG001|Reported Event|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
10931830|NCT00718159|BG000|Baseline|Cmax 250 μg/mL (AML)|Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
10931831|NCT00718159|BG001|Baseline|Cmax 300 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931832|NCT00718159|BG002|Baseline|Cmax 350 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931833|NCT00718159|BG003|Baseline|Cmax 400 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931834|NCT00718159|BG004|Baseline|AUCalb 5500 µg*hr/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms*hour per milliliter (µg*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
10931835|NCT00718159|BG005|Baseline|AUCalb 7000 µg*hr/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
10931836|NCT00718159|BG006|Baseline|AUCalb 5500 µg*hr/mL (ET)|Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
10931837|NCT00718159|BG007|Baseline|Total|Total of all reporting groups
10931838|NCT00718159|FG000|Participant Flow|Cmax 250 μg/mL (AML)|Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
10931839|NCT00718159|FG001|Participant Flow|Cmax 300 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931840|NCT00718159|FG002|Participant Flow|Cmax 350 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931841|NCT00718159|FG003|Participant Flow|Cmax 400 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931842|NCT00718159|FG004|Participant Flow|AUCalb 5500 µg*hr/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms*hour per milliliter (µg*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
10931843|NCT00718159|FG005|Participant Flow|AUCalb 7000 µg*hr/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
10931844|NCT00718159|FG006|Participant Flow|AUCalb 5500 µg*hr/mL (ET)|Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
10931845|NCT00718159|OG000|Outcome|Cmax 250 μg/mL (AML)|Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
10931846|NCT00718159|OG001|Outcome|Cmax 300 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931847|NCT00718159|OG002|Outcome|Cmax 350 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931848|NCT00718159|OG003|Outcome|Cmax 400 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931849|NCT00718159|OG004|Outcome|AUCalb 5500 µg*hr/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms*hour per milliliter (µg*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.
10931850|NCT00718159|OG005|Outcome|AUCalb 7000 µg*hr/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
10931851|NCT00718159|OG006|Outcome|AUCalb 5500 µg*hr/mL (ET)|Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle.
10931852|NCT00718159|OG000|Outcome|LY573636|LY573636 dose was based on an albumin-corrected exposure (AUCalb) to target a specific exposure range. Intravenous dosing is done on Day 1 of Cycle 1. Data are pooled together from all treatment groups.
10931853|NCT00718159|EG000|Reported Event|Cmax 250 μg/mL (AML)|Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle.
10931854|NCT00718159|EG001|Reported Event|Cmax 300 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931855|NCT00718159|EG002|Reported Event|Cmax 350 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931856|NCT00718159|EG003|Reported Event|Cmax 400 μg/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle.
10931857|NCT00718159|EG004|Reported Event|AUCalb 5500 µg*hr/mL (AML and ET)|"Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms*hour per milliliter (µg*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle.~Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle."
10931858|NCT00718159|EG005|Reported Event|AUCalb 7000 µg*hr/mL (AML)|Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle.
10931859|NCT00718237|BG000|Baseline|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10931860|NCT00718237|BG001|Baseline|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
10931861|NCT00718237|BG002|Baseline|Total|Total of all reporting groups
10931862|NCT00718237|FG000|Participant Flow|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10931863|NCT00718237|FG001|Participant Flow|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
10931864|NCT00718237|OG000|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
10931865|NCT00718237|OG001|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
10931866|NCT00718237|OG000|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10931867|NCT00718237|OG001|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study
10931868|NCT00718237|EG000|Reported Event|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
10931869|NCT00718237|EG001|Reported Event|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
10931870|NCT00718302|BG000|Baseline|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws.
10931871|NCT00718302|BG001|Baseline|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
11240641|NCT02481050|EG000|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
10931872|NCT00718302|BG002|Baseline|Total|Total of all reporting groups
10931873|NCT00718302|FG000|Participant Flow|Antiglide Plate|Antiglide Plate: A plate is placed behind the broken ankle and secured with screws
10931874|NCT00718302|FG001|Participant Flow|Lateral Plate|Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws
10931875|NCT00718302|OG000|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
10931876|NCT00718302|OG001|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
10931877|NCT00718302|OG000|Outcome|Randomized Treatment; Antiglide Plate|"Randomized treatment; antiglide plate~Antiglide Plate: A plate is placed behind the broken ankle and secured with screws"
10931878|NCT00718302|OG001|Outcome|Randomized Treatment; Lateral Plate|"Randomized treatment; lateral plate~Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws"
10931879|NCT00718302|EG000|Reported Event|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
10931880|NCT00718302|EG001|Reported Event|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
10931881|NCT00718315|BG000|Baseline|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931882|NCT00718315|BG001|Baseline|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931883|NCT00718315|BG002|Baseline|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931884|NCT00718315|BG003|Baseline|Total|Total of all reporting groups
10931885|NCT00718315|FG000|Participant Flow|Fisiogel|Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931886|NCT00718315|FG001|Participant Flow|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931887|NCT00718315|FG002|Participant Flow|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931888|NCT00718315|OG000|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931889|NCT00718315|OG001|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931890|NCT00718315|OG002|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
10931891|NCT00718315|EG000|Reported Event|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931892|NCT00718315|EG001|Reported Event|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
10931893|NCT00718315|EG002|Reported Event|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
10931894|NCT00718328|BG000|Baseline|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
10931895|NCT00718328|BG001|Baseline|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
10931896|NCT00718328|BG002|Baseline|Total|Total of all reporting groups
10931897|NCT00718328|FG000|Participant Flow|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
10931898|NCT00718328|FG001|Participant Flow|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
11175911|NCT02032550|EG000|Reported Event|Preference Based Decision Aid|"The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.~Preference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes."
11175912|NCT02032550|EG001|Reported Event|Usual Care|Participants randomized into this group will have usual care from their doctors without any intervention
10931899|NCT00718328|OG000|Outcome|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
10931900|NCT00718328|OG001|Outcome|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
10931901|NCT00718328|EG000|Reported Event|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
10931902|NCT00718328|EG001|Reported Event|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
10931903|NCT00718419|BG000|Baseline|Multiple Myeloma (MM)|Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
10931904|NCT00718419|BG001|Baseline|Waldenstrom's Macroglobulinemia (WM)|Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
10931905|NCT00718419|BG002|Baseline|Total|Total of all reporting groups
10931906|NCT00718419|FG000|Participant Flow|Multiple Myeloma (MM)|Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
10931907|NCT00718419|FG001|Participant Flow|Waldenstrom's Macroglobulinemia (WM)|Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
10931908|NCT00718419|OG000|Outcome|Multiple Myeloma (MM)|Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
10931909|NCT00718419|OG001|Outcome|Waldenstrom's Macroglobulinemia (WM)|Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
10931910|NCT00718419|EG000|Reported Event|Multiple Myeloma (MM)|Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
10931911|NCT00718419|EG001|Reported Event|Waldenstrom's Macroglobulinemia (WM)|Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
10931912|NCT00718510|BG000|Baseline|L-arginine Treatment First, Placebo Treatment Second|The trial participants received 6 g p.o. (3 g twice per day at 0800h and 2000h) of L-arginine 500mg capsules for 3 weeks in addition to their antipsychotic treatment as usual. After a 5 day washout period, they then received placebo capsules (matching L-arginine 500mg) 6g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual.
10931913|NCT00718510|BG001|Baseline|Placebo Treatment First, L-arginine Treatment Second|The trial participants received the placebo capsules (matching L-arginine 500mg) 6 g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual. After a 5 day washout period, they then received L-arginine (500mg capsules) 6g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual.
10931914|NCT00718510|BG002|Baseline|Total|Total of all reporting groups
10931915|NCT00718510|FG000|Participant Flow|L-arginine Treatment First, Placebo Treatment Second|The trial participants received 6 g p.o. (3 g twice per day at 0800h and 2000h) of L-arginine 500mg capsules for 3 weeks in addition to their antipsychotic treatment as usual. After a 5 day washout period, they then received placebo capsules (matching L-arginine 500mg) 6g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual.
10931916|NCT00718510|FG001|Participant Flow|Placebo Treatment First, L-arginine Treatment Second|The trial participants received the placebo capsules (matching L-arginine 500mg) 6 g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual. After a 5 day washout period, they then received L-arginine (500mg capsules) 6g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual.
10931917|NCT00718510|OG000|Outcome|L-arginine|Participants who received L-arginine 6 g (500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study
10931918|NCT00718510|OG001|Outcome|Placebo|Participants who received Placebo 6 g (matching L-arginine 500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study.
10931919|NCT00718510|EG000|Reported Event|L-arginine|Participants who received L-arginine 6 g (500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study
10931920|NCT00718510|EG001|Reported Event|Placebo|Participants who received Placebo 6 g (matching L-arginine 500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study.
11240642|NCT02481141|BG000|Baseline|5-ALA-SFC|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks~5-ALA-SFC: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA - SFC"
10931921|NCT00718523|BG000|Baseline|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
10931922|NCT00718523|BG001|Baseline|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
10931923|NCT00718523|BG002|Baseline|Total|Total of all reporting groups
10931924|NCT00718523|FG000|Participant Flow|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
10931925|NCT00718523|FG001|Participant Flow|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
10931926|NCT00718523|OG000|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
10931927|NCT00718523|OG001|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
10931928|NCT00718523|EG000|Reported Event|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
10931929|NCT00718523|EG001|Reported Event|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
10931930|NCT00718549|BG000|Baseline|Induction: Rituximab, Cladribine, Cyclophosphamide|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1, cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 in Cycle 1. Then, rituximab at a dose of 500 mg/m^2 as IV infusion on Day 1, cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 were administered in Cycles 2-6. Each cycle was of 28 days in duration.
10963311|NCT00871403|FG002|Participant Flow|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
10931931|NCT00718549|FG000|Participant Flow|Induction: Rituximab, Cladribine, Cyclophosphamide|Participants received rituximab at a dose of 375 milligrams per meter squared (mg/m^2) as intravenous (IV) infusion on Day 1, cladribine at a dose of 0.12 milligrams per kilogram per day (mg/kg/day) as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 minutes (min) on Days 2-4 in Cycle 1. Then, rituximab at a dose of 500 mg/m^2 as IV infusion on Day 1, cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 were administered in Cycles 2-6. Each cycle was of 28 days in duration.
10931932|NCT00718549|FG001|Participant Flow|Maintenance Arm: Rituximab|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6, along with cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 of each 28-days cycle for 6 cycles during induction phase. Participants with PR or CR after induction phase who were randomized to maintenance arm received rituximab treatment for 8 cycles. Twelve weeks after the last induction cycle, participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle until disease progression (up to approximately 96 weeks).
10931933|NCT00718549|FG002|Participant Flow|Observation Arm: No Intervention|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6, along with cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 of each 28-days cycle for 6 cycles during induction phase. Participants with PR or CR after induction phase who were randomized to observation arm did not receive any intervention. Participants were assessed every 4-weeks for the first 12 weeks and every 12-weeks afterwards up to 96 weeks.
10931934|NCT00718549|OG000|Outcome|Maintenance Arm: Rituximab|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6, along with cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 of each 28-days cycle for 6 cycles during induction phase. Participants with PR or CR after induction phase who were randomized to maintenance arm received rituximab treatment for 8 cycles. Twelve weeks after the last induction cycle, participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle until disease progression (up to approximately 96 weeks).
10931935|NCT00718549|OG001|Outcome|Observation Arm: No Intervention|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6, along with cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 of each 28-days cycle for 6 cycles during induction phase. Participants with PR or CR after induction phase who were randomized to observation arm did not receive any intervention. Participants were assessed every 4-weeks for the first 12 weeks and every 12-weeks afterwards up to 96 weeks.
10931936|NCT00718549|OG002|Outcome|All Randomized Participants|Participants with PR or CR after induction phase were randomized to observation arm (received no intervention) or to maintenance arm (12 weeks after the last induction cycle, participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle for 8 cycles or until disease progression [up to approximately 96 weeks]).
10931937|NCT00718549|OG002|Outcome|Overall Population|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6, along with cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 of each 28-days cycle for 6 cycles during induction phase. Participants with PR or CR after induction phase were randomized to observation arm (received no intervention) or to maintenance arm (12 weeks after the last induction cycle, participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle for 8 cycles or until disease progression [up to approximately 96 weeks]).
10931938|NCT00718549|OG000|Outcome|All Randomized Participants|Participants with PR or CR after induction phase were randomized to observation arm (received no intervention) or to maintenance arm (12 weeks after the last induction cycle, participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle for 8 cycles or until disease progression [up to approximately 96 weeks]).
10931939|NCT00718549|OG000|Outcome|Overall Population|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6, along with cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 of each 28-days cycle for 6 cycles during induction phase. Participants with PR or CR after induction phase were randomized to observation arm (received no intervention) or to maintenance arm (12 weeks after the last induction cycle, participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle for 8 cycles or until disease progression [up to approximately 96 weeks]).
10931940|NCT00718549|OG000|Outcome|All Randomized Participants|Participants with PR or CR after induction phase were randomized to either observation arm (received no intervention) or to maintenance arm (received maintenance treatment with rituximab administered at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle for 8 cycles until disease progression for up to approximately 96 weeks).
10931941|NCT00718549|EG000|Reported Event|Induction (Excluding Maintenance/ Observation)|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1, cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 in Cycle 1. Then, rituximab at a dose of 500 mg/m^2 as IV infusion on Day 1, cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 were administered in Cycles 2-6. Each cycle was of 28 days in duration. Only participants who were not randomized to maintenance or observation arm were included.
10963312|NCT00871403|OG000|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
10931942|NCT00718549|EG001|Reported Event|Maintenance Arm: Rituximab|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6, along with cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 of each 28-days cycle for 6 cycles during induction phase. Participants with PR or CR after induction phase who were randomized to maintenance arm received rituximab treatment for 8 cycles. Twelve weeks after the last induction cycle, participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle until disease progression (up to approximately 96 weeks).
10931943|NCT00718549|EG002|Reported Event|Observation Arm: No Intervention|Participants received rituximab at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6, along with cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m^2/day as IV infusion over 15-30 min on Days 2-4 of each 28-days cycle for 6 cycles during induction phase. Participants with PR or CR after induction phase who were randomized to observation arm did not receive any intervention. Participants were assessed every 4-weeks for the first 12 weeks and every 12-weeks afterwards up to 96 weeks.
10931944|NCT00718549|EG003|Reported Event|All Participants|All enrolled participants who received at least one dose of study medication were included in the analysis.
10931945|NCT00718666|BG000|Baseline|Nimenrix 1 Group Y1|Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.
10931946|NCT00718666|BG001|Baseline|Nimenrix 2 Group Y1|Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
10931947|NCT00718666|BG002|Baseline|Nimenrix Naive Group|Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
10931948|NCT00718666|BG003|Baseline|Total|Total of all reporting groups
10931949|NCT00718666|FG000|Participant Flow|Nimenrix 1 Group|Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.
10931950|NCT00718666|FG001|Participant Flow|Nimenrix 2 Group|Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
10931951|NCT00718666|FG002|Participant Flow|Nimenrix Naive Group|Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
10931952|NCT00718666|OG000|Outcome|Nimenrix 1 Group Y1|Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.
10931953|NCT00718666|OG001|Outcome|Nimenrix 2 Group Y1|Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
11175913|NCT02032641|BG000|Baseline|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.~Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
10931954|NCT00718666|OG000|Outcome|Nimenrix 1 Group Y3|Subjects from Year 3 Period who received 1 dose on Nimenrix vaccine at 12 months of age.
10931955|NCT00718666|OG001|Outcome|Nimenrix 2 Group Y3|Subjects from Year 3 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
10931956|NCT00718666|OG000|Outcome|Nimenrix 1 Group Y5|Subjects from Year 5 Period who received 1 dose on Nimenrix vaccine at 12 months of age.
10931957|NCT00718666|OG001|Outcome|Nimenrix 2 Group Y5|Subjects from Year 5 period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
10931958|NCT00718666|OG001|Outcome|Nimenrix 2 Group Y5|Subjects from Year 5 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
10931959|NCT00718666|OG000|Outcome|Nimenrix 1 Group Y3|Subjects who received 1 dose on Nimenrix vaccine at 12 months of age.
10931960|NCT00718666|OG001|Outcome|Nimenrix 2 Group Y3|Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
10931961|NCT00718666|OG000|Outcome|Nimenrix Naive Group|Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
10931962|NCT00718666|OG000|Outcome|Nimenrix 1 Booster Group Y5|Subjects who received 1 dose on Nimenrix vaccine at 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination).
10931963|NCT00718666|OG001|Outcome|Nimenrix 2 Booster Group Y5|Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age and a booster dose of Nimenrix vaccine at Year 5 (60 months post-primary vacccination).
10931964|NCT00718666|OG002|Outcome|Nimenrix Naive Group Y5|Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
10931965|NCT00718666|EG000|Reported Event|Nimenrix 1 Group|Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.
10931966|NCT00718666|EG001|Reported Event|Nimenrix 2 Group|Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
10931967|NCT00718666|EG002|Reported Event|Nimenrix Naive Group|Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
10931968|NCT00718718|BG000|Baseline|Part A: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
10931969|NCT00718718|BG001|Baseline|Part A: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Week 12 and q2w through week 22.
10931970|NCT00718718|BG002|Baseline|Part B: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
10931971|NCT00718718|BG003|Baseline|Part B: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
10931972|NCT00718718|BG004|Baseline|Part B: Sirukumab 100 mg q4 Weeks|Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931973|NCT00718718|BG005|Baseline|Part B: Sirukumab 50 mg q4 Weeks|Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931974|NCT00718718|BG006|Baseline|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931975|NCT00718718|BG007|Baseline|Total|Total of all reporting groups
10931976|NCT00718718|FG000|Participant Flow|Part A - Placebo (Wk 0-Wk 12)|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks.
10931977|NCT00718718|FG001|Participant Flow|Part A - Placebo Then Sirukumab (Wk 12 to End of Study)|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
10931978|NCT00718718|FG002|Participant Flow|Part A - Sirukumab (Wk 0-Wk 12)|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
10931979|NCT00718718|FG003|Participant Flow|Part A - Sirukumab Then Placebo (Wk 12 to End of Study)|Participants received placebo at Weeks 12 and q2w through Week 22.
10931980|NCT00718718|FG004|Participant Flow|Part B - Placebo (Wk 0-Wk 12)|Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
10931981|NCT00718718|FG005|Participant Flow|Part B - Placebo Then Sirukumab 100 mg q2 Weeks|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
11175914|NCT02032641|FG000|Participant Flow|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.~Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
10931982|NCT00718718|FG006|Participant Flow|Part B - Sirukumab 100mg q2w|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
10931983|NCT00718718|FG007|Participant Flow|Part B - Sirukumab 100mg q4w|Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
10931984|NCT00718718|FG008|Participant Flow|Part B - Sirukumab 50mg q4w|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
10931985|NCT00718718|FG009|Participant Flow|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931986|NCT00718718|OG000|Outcome|Part B: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
10931987|NCT00718718|OG001|Outcome|Part B: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
10931988|NCT00718718|OG002|Outcome|Part B: Sirukumab 100 mg q4 Weeks|Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931989|NCT00718718|OG003|Outcome|Part B: Sirukumab 50 mg q4 Weeks|Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931990|NCT00718718|OG004|Outcome|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931991|NCT00718718|OG000|Outcome|Part A: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
10931992|NCT00718718|OG001|Outcome|Part A: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
10931993|NCT00718718|OG002|Outcome|Part B: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
10931994|NCT00718718|OG003|Outcome|Part B: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
10931995|NCT00718718|OG004|Outcome|Part B: Sirukumab 100 mg q4 Weeks|Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931996|NCT00718718|OG005|Outcome|Part B: Sirukumab 50 mg q4 Weeks|Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931997|NCT00718718|OG006|Outcome|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
10931998|NCT00718718|OG005|Outcome|Part A: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
10931999|NCT00718718|OG006|Outcome|Part A: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
10932000|NCT00718718|EG000|Reported Event|Part A - Placebo (Wk 0-Wk 12)|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks
10932001|NCT00718718|EG001|Reported Event|Part A - Placebo Then Sirukumab (Wk 12 to End of Study)|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
10932002|NCT00718718|EG002|Reported Event|Part A - Sirukumab (Wk 0-Wk 12)|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
10932003|NCT00718718|EG003|Reported Event|Part A - Sirukumab Then Placebo (Wk 12 to End of Study)|Participants received placebo at Weeks 12 and q2w through Week 22.
10932004|NCT00718718|EG004|Reported Event|Part B - Placebo (Wk 0-Wk 12)|Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
10932005|NCT00718718|EG005|Reported Event|Part B - Placebo Then Sirukumab 100 mg q2 Weeks|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
10932006|NCT00718718|EG006|Reported Event|Part B - Sirukumab 100mg q2w|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
10932007|NCT00718718|EG007|Reported Event|Part B - Sirukumab 100mg q4w|Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
10932008|NCT00718718|EG008|Reported Event|Part B - Sirukumab 50mg q4w|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
10932009|NCT00718718|EG009|Reported Event|Part B - Sirukumab 25mg q4w|Participants received 25 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
11175915|NCT02032641|OG000|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
10932010|NCT00718770|BG000|Baseline|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
10932011|NCT00718770|FG000|Participant Flow|Bexarotene|"Open label - all patients received the intervention~Bexarotene : Bexarotene was given by mouth once a day every day for 1 year. The dose used was 300 mg/m2."
10932012|NCT00718770|OG000|Outcome|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
10932013|NCT00718770|EG000|Reported Event|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
10963313|NCT00871403|OG001|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
10963314|NCT00871403|EG000|Reported Event|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
10963315|NCT00871403|EG001|Reported Event|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
10963316|NCT00871403|EG002|Reported Event|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
10963317|NCT00871429|BG000|Baseline|Cancer Patients Using Lindi Skin Products|
10963318|NCT00871429|FG000|Participant Flow|Lindi Skin Participant Flow|
10963319|NCT00871429|OG000|Outcome|Lindi Skin Soothing Balm (Product A)|
10963320|NCT00871429|OG001|Outcome|Lindi Skin Face Wash (Product C)|
10963321|NCT00871429|OG002|Outcome|Lindi Skin Face Serum (Product B)|
10963322|NCT00871429|EG000|Reported Event|Lindi Skin Soothing Balm (Product A)|
10963323|NCT00871429|EG001|Reported Event|Lindi Skin Face Wash (Product C)|
10963324|NCT00871429|EG002|Reported Event|Lindi Skin Face Serum (Product B)|
10963325|NCT00871494|BG000|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
10963326|NCT00871494|FG000|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
10963327|NCT00871494|OG000|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
10932014|NCT00718809|BG000|Baseline|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10932015|NCT00718809|BG001|Baseline|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10932016|NCT00718809|BG002|Baseline|Total|Total of all reporting groups
10932017|NCT00718809|FG000|Participant Flow|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10932018|NCT00718809|FG001|Participant Flow|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10932019|NCT00718809|OG000|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10932020|NCT00718809|OG001|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10932021|NCT00718809|EG000|Reported Event|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10932022|NCT00718809|EG001|Reported Event|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10932023|NCT00718861|BG000|Baseline|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
10932024|NCT00718861|BG001|Baseline|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
10932025|NCT00718861|BG002|Baseline|Total|Total of all reporting groups
10932026|NCT00718861|FG000|Participant Flow|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
10932027|NCT00718861|FG001|Participant Flow|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
10932028|NCT00718861|OG000|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
10932029|NCT00718861|OG001|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
10932030|NCT00718861|EG000|Reported Event|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
10932031|NCT00718861|EG001|Reported Event|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
10932032|NCT00718887|BG000|Baseline|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
11175916|NCT02032641|OG001|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
10932033|NCT00718887|BG001|Baseline|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
11175917|NCT02032641|EG000|Reported Event|Laser Right, Non-laser Left|Group which had the right post-operative scar assigned to receive laser treatment
10932034|NCT00718887|BG002|Baseline|Total|Total of all reporting groups
10932035|NCT00718887|FG000|Participant Flow|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
10932036|NCT00718887|FG001|Participant Flow|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
10932037|NCT00718887|OG000|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD) for a maximum of 52 weeks.
10932038|NCT00718887|OG001|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
10932039|NCT00718887|OG000|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
10932040|NCT00718887|OG001|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
10932041|NCT00718887|OG001|Outcome|Adeforvi, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
10932042|NCT00718887|OG000|Outcome|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
10932043|NCT00718887|OG001|Outcome|Adefovir, 10 mg QD/Entecavir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
10932044|NCT00718887|OG001|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
10932045|NCT00718887|EG000|Reported Event|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
10932046|NCT00718887|EG001|Reported Event|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
10932047|NCT00719043|BG000|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932048|NCT00719043|BG001|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932049|NCT00719043|BG002|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932050|NCT00719043|BG003|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932051|NCT00719043|BG004|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932052|NCT00719043|BG005|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932053|NCT00719043|BG006|Baseline|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
10932054|NCT00719043|BG007|Baseline|Total|Total of all reporting groups
10932055|NCT00719043|FG000|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10963328|NCT00871494|EG000|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
10963329|NCT00871572|BG000|Baseline|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
10963330|NCT00871572|BG001|Baseline|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
10932056|NCT00719043|FG001|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932057|NCT00719043|FG002|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932058|NCT00719043|FG003|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932059|NCT00719043|FG004|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932060|NCT00719043|FG005|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932061|NCT00719043|FG006|Participant Flow|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
10932062|NCT00719043|OG000|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932063|NCT00719043|OG001|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932064|NCT00719043|OG002|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932065|NCT00719043|OG003|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10963331|NCT00871572|BG002|Baseline|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
10963332|NCT00871572|BG003|Baseline|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
10963333|NCT00871572|BG004|Baseline|Total|Total of all reporting groups
10932066|NCT00719043|OG000|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
10932067|NCT00719043|OG000|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932068|NCT00719043|OG001|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932069|NCT00719043|OG002|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932070|NCT00719043|OG003|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932071|NCT00719043|OG004|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932072|NCT00719043|OG005|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
11175918|NCT02032641|EG001|Reported Event|Laser Left, Non-laser RIght|Group which had the right post-operative scar assigned to receive laser treatment
10932073|NCT00719043|OG006|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
10932074|NCT00719043|OG000|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
10932075|NCT00719043|OG002|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
10932076|NCT00719043|OG000|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932077|NCT00719043|OG001|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932078|NCT00719043|OG002|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932079|NCT00719043|OG003|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932080|NCT00719043|OG004|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
10932081|NCT00719043|EG000|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932082|NCT00719043|EG001|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932083|NCT00719043|EG002|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932084|NCT00719043|EG003|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932085|NCT00719043|EG004|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932086|NCT00719043|EG005|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
10932087|NCT00719043|EG006|Reported Event|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
11240643|NCT02481141|BG001|Baseline|Placebo|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks~Placebo"
10932088|NCT00719134|BG000|Baseline|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
10932089|NCT00719134|FG000|Participant Flow|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
10932090|NCT00719134|OG000|Outcome|All Participants|
10932091|NCT00719134|EG000|Reported Event|Maxalt|
10932092|NCT00719134|EG001|Reported Event|Placebo|
10932093|NCT00719160|BG000|Baseline|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
10932094|NCT00719160|FG000|Participant Flow|Intervention Esomeprazole First/Placebo Second|In this group this group received the intervention first and then the placebo
10932095|NCT00719160|FG001|Participant Flow|Intervention Placebo First/Esomeprazole Second|In this group this group received the placebo first and then the intervention
10932096|NCT00719160|OG000|Outcome|Esomeprazole|Esomeprazoled administered twice daily in either first or second intervention period
10932097|NCT00719160|OG001|Outcome|Placebo|Placebo administered twice daily in either first or second intervention
10932098|NCT00719160|OG000|Outcome|Esomeprazole Study Drug|Esomeprazole 20 mg twice daily given as either the first or second intervention
10932099|NCT00719160|OG001|Outcome|Placebo|Placebo 20 mg twice a day given as either the first or second intervention.
10932100|NCT00719160|EG000|Reported Event|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
10932101|NCT00719186|BG000|Baseline|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
10932102|NCT00719186|BG001|Baseline|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
10932103|NCT00719186|BG002|Baseline|Total|Total of all reporting groups
10932104|NCT00719186|FG000|Participant Flow|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
10932105|NCT00719186|FG001|Participant Flow|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
10932106|NCT00719186|OG000|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
10932107|NCT00719186|OG001|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
10932108|NCT00719186|EG000|Reported Event|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
10932109|NCT00719186|EG001|Reported Event|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
10932110|NCT00719212|BG000|Baseline|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
10932111|NCT00719212|FG000|Participant Flow|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
10932112|NCT00719212|OG000|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
10932113|NCT00719212|EG000|Reported Event|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
10932114|NCT00719264|BG000|Baseline|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
10932115|NCT00719264|BG001|Baseline|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
10932116|NCT00719264|BG002|Baseline|Total|Total of all reporting groups
10932117|NCT00719264|FG000|Participant Flow|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
10932118|NCT00719264|FG001|Participant Flow|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
10932119|NCT00719264|OG000|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
10932120|NCT00719264|OG001|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
10932121|NCT00719264|EG000|Reported Event|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
10963334|NCT00871572|FG000|Participant Flow|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
10932122|NCT00719264|EG001|Reported Event|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
10932123|NCT00719329|BG000|Baseline|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
10932124|NCT00719329|BG001|Baseline|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
10932125|NCT00719329|BG002|Baseline|Dry Cord Care|Dry cord care, as recommended by WHO
10932126|NCT00719329|BG003|Baseline|Total|Total of all reporting groups
10932127|NCT00719329|FG000|Participant Flow|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
10932128|NCT00719329|FG001|Participant Flow|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
10932129|NCT00719329|FG002|Participant Flow|Dry Cord Care|Dry cord care, as recommended by WHO
10932130|NCT00719329|OG000|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing to the cord
10932131|NCT00719329|OG001|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing to the cord
10932132|NCT00719329|OG002|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord
10932133|NCT00719329|OG000|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
10932134|NCT00719329|OG001|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
10932135|NCT00719329|OG002|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
10932136|NCT00719329|EG000|Reported Event|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
10932137|NCT00719329|EG001|Reported Event|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
10932138|NCT00719329|EG002|Reported Event|Dry Cord Care|Dry cord care, as recommended by WHO
10932139|NCT00719355|BG000|Baseline|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
10932140|NCT00719355|BG001|Baseline|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
10932141|NCT00719355|BG002|Baseline|Total|Total of all reporting groups
10932142|NCT00719355|FG000|Participant Flow|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
10932143|NCT00719355|FG001|Participant Flow|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
10932144|NCT00719355|OG000|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
10932145|NCT00719355|OG001|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
10932146|NCT00719355|EG000|Reported Event|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
10932147|NCT00719355|EG001|Reported Event|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
10932148|NCT00719472|BG000|Baseline|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
10932149|NCT00719472|FG000|Participant Flow|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
10932150|NCT00719472|OG000|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
10932151|NCT00719472|EG000|Reported Event|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
10932152|NCT00719537|BG000|Baseline|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
10932153|NCT00719537|BG001|Baseline|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
10932154|NCT00719537|BG002|Baseline|Total|Total of all reporting groups
10932155|NCT00719537|FG000|Participant Flow|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
10932156|NCT00719537|FG001|Participant Flow|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
10932157|NCT00719537|OG000|Outcome|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
10932158|NCT00719537|OG001|Outcome|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
10932159|NCT00719537|EG000|Reported Event|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo
10932160|NCT00719537|EG001|Reported Event|Aspirin and Progesterone|Aspirin and progesterone: aspirin 81 mg once a day oral progesterone 200mg twice daily
10932161|NCT00719563|BG000|Baseline|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
10932162|NCT00719563|BG001|Baseline|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
10932163|NCT00719563|BG002|Baseline|Total|Total of all reporting groups
10932164|NCT00719563|FG000|Participant Flow|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
10932165|NCT00719563|FG001|Participant Flow|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
10932166|NCT00719563|OG000|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
10932167|NCT00719563|OG001|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
10932168|NCT00719563|OG001|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..
10932169|NCT00719563|EG000|Reported Event|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
10932170|NCT00719563|EG001|Reported Event|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
10932171|NCT00719576|BG000|Baseline|MACI|autologous cultured chondrocytes on porcine collagen membrane
10932172|NCT00719576|BG001|Baseline|Microfracture|Microfracture
10932173|NCT00719576|BG002|Baseline|Total|Total of all reporting groups
10932174|NCT00719576|FG000|Participant Flow|MACI|autologous cultured chondrocytes on porcine collagen membrane
10932175|NCT00719576|FG001|Participant Flow|Microfracture|"Microfracture~Microfracture: Microfracture"
10932176|NCT00719576|OG000|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane
10932177|NCT00719576|OG001|Outcome|Microfracture|"Microfracture~Microfracture: Microfracture"
10932178|NCT00719576|OG001|Outcome|Microfracture|Microfracture: Microfracture
10932179|NCT00719576|OG001|Outcome|Microfracture|Microfracture
10932180|NCT00719576|EG000|Reported Event|MACI|autologous cultured chondrocytes on porcine collagen membrane
10932181|NCT00719576|EG001|Reported Event|Microfracture|Microfracture
10932182|NCT00719615|BG000|Baseline|Thyroid Nodules|
10932183|NCT00719615|BG001|Baseline|Thyroid Cancer in Remission|
10932184|NCT00719615|BG002|Baseline|Active Thyroid Cancer|
10932185|NCT00719615|BG003|Baseline|Total|Total of all reporting groups
11240644|NCT02481141|BG002|Baseline|Total|Total of all reporting groups
10932186|NCT00719615|FG000|Participant Flow|Thyroid Nodules|
10932187|NCT00719615|FG001|Participant Flow|Thyroid Cancer in Remission|
10932188|NCT00719615|FG002|Participant Flow|Active Thyroid Cancer|
10932189|NCT00719615|OG000|Outcome|Thyroid Nodules|
10932190|NCT00719615|OG001|Outcome|Thyroid Cancer in Remission|
10932191|NCT00719615|OG002|Outcome|Active Thyroid Cancer|
10932192|NCT00719615|EG000|Reported Event|Thyroid Nodules|
10932193|NCT00719615|EG001|Reported Event|Thyroid Cancer in Remission|
10932194|NCT00719615|EG002|Reported Event|Active Thyroid Cancer|
10932195|NCT00719680|BG000|Baseline|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
10932196|NCT00719680|FG000|Participant Flow|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
10932197|NCT00719680|OG000|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
10932198|NCT00719680|EG000|Reported Event|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
10932199|NCT00719706|BG000|Baseline|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
10932200|NCT00719706|BG001|Baseline|Placebo|Participants taking placebo.
10932201|NCT00719706|BG002|Baseline|Total|Total of all reporting groups
10932202|NCT00719706|FG000|Participant Flow|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
10932203|NCT00719706|FG001|Participant Flow|Placebo|Participants taking placebo.
10932204|NCT00719706|OG000|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
10932205|NCT00719706|OG001|Outcome|Placebo|Participants taking placebo.
10932206|NCT00719706|EG000|Reported Event|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
10932207|NCT00719706|EG001|Reported Event|Placebo|Participants taking placebo.
10932208|NCT00719732|BG000|Baseline|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
10932209|NCT00719732|FG000|Participant Flow|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
10963335|NCT00871572|FG001|Participant Flow|10 mg LY2409021|10 milligram (mg) LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
10932210|NCT00719732|OG000|Outcome|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
10932211|NCT00719732|EG000|Reported Event|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
10932212|NCT00719810|BG000|Baseline|Delafloxacin 300 mg IV q12h|
10932213|NCT00719810|BG001|Baseline|Delafloxacin 450 mg IV q12h|
10932214|NCT00719810|BG002|Baseline|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
10932215|NCT00719810|BG003|Baseline|Total|Total of all reporting groups
10932216|NCT00719810|FG000|Participant Flow|Delafloxacin 300 mg IV q12h|
10932217|NCT00719810|FG001|Participant Flow|Delafloxacin 450 mg IV q12h|
10932218|NCT00719810|FG002|Participant Flow|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
10932219|NCT00719810|OG000|Outcome|Delafloxacin 300 mg IV q12h|
10932220|NCT00719810|OG001|Outcome|Delafloxacin 450 mg IV q12h|
10932221|NCT00719810|OG002|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
10932222|NCT00719810|EG000|Reported Event|Delafloxacin 300 mg IV q12h|
10932223|NCT00719810|EG001|Reported Event|Delafloxacin 450 mg IV q12h|
10932224|NCT00719810|EG002|Reported Event|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
10932225|NCT00719849|BG000|Baseline|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day -6~Fludarabine 40mg/m2 Days -6 to -2~TBI 200 cGy Day -1~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
10932226|NCT00719849|BG001|Baseline|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.~Cyclophosphamide 50 mg/Kg Day -6~Fludarabine 40mg/m2 Days -6 to -2~TBI 200 cGy Day -1~Equine ATG 30mg/Kg Days -6 to -4~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
10932227|NCT00719849|BG002|Baseline|Total|Total of all reporting groups
10932228|NCT00719849|FG000|Participant Flow|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day -6~Fludarabine 40mg/m2 Days -6 to -2~TBI 200 cGy Day -1~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
10932229|NCT00719849|FG001|Participant Flow|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.~Cyclophosphamide 50 mg/Kg Day -6~Fludarabine 40mg/m2 Days -6 to -2~TBI 200 cGy Day -1~Equine ATG 30mg/Kg Days -6 to -4~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
10932230|NCT00719849|OG000|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day -6~Fludarabine 40mg/m2 Days -6 to -2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
10932231|NCT00719849|OG001|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day -6~Fludarabine 40mg/m2 Days -6 to -2~TBI 200 cGy Day -1~Equine ATG 30mg/Kg Days -6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
10932232|NCT00719849|EG000|Reported Event|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day -6~Fludarabine 40mg/m2 Days -6 to -2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
10932233|NCT00719849|EG001|Reported Event|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day -6~Fludarabine 40mg/m2 Days -6 to -2~TBI 200 cGy Day -1~Equine ATG 30mg/Kg Days -6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
10932234|NCT00719862|BG000|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
10932235|NCT00719862|BG001|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
10932236|NCT00719862|BG002|Baseline|Total|Total of all reporting groups
10932237|NCT00719862|FG000|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
10932238|NCT00719862|FG001|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
10932239|NCT00719862|OG000|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
10932240|NCT00719862|OG001|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
10932241|NCT00719862|EG000|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
10932242|NCT00719862|EG001|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
10932243|NCT00719901|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10932244|NCT00719901|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10932245|NCT00719901|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10932246|NCT00719901|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10932247|NCT00719953|BG000|Baseline|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
10932248|NCT00719953|FG000|Participant Flow|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
10932249|NCT00719953|OG000|Outcome|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
10932250|NCT00719953|EG000|Reported Event|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
10932251|NCT00720057|BG000|Baseline|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
10932252|NCT00720057|BG001|Baseline|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
10932253|NCT00720057|BG002|Baseline|Total|Total of all reporting groups
10932254|NCT00720057|FG000|Participant Flow|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
10932255|NCT00720057|FG001|Participant Flow|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
10932256|NCT00720057|OG000|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
10932257|NCT00720057|OG001|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
10932258|NCT00720057|EG000|Reported Event|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
10932259|NCT00720057|EG001|Reported Event|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
10932260|NCT00720096|BG000|Baseline|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
10932261|NCT00720096|BG001|Baseline|Topotecan|Topotecan - Chemotherapy single agent systemic.
10932262|NCT00720096|BG002|Baseline|Total|Total of all reporting groups
10932263|NCT00720096|FG000|Participant Flow|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
10932264|NCT00720096|FG001|Participant Flow|Topotecan|Topotecan - Chemotherapy single agent systemic.
10932265|NCT00720096|OG000|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
10932266|NCT00720096|OG001|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
10932267|NCT00720096|EG000|Reported Event|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
10932268|NCT00720096|EG001|Reported Event|Topotecan|Topotecan - Chemotherapy single agent systemic.
10932269|NCT00720109|BG000|Baseline|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
10932270|NCT00720109|FG000|Participant Flow|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
10932271|NCT00720109|FG001|Participant Flow|Standard-risk|Based on Minimal Residual Disease, less than 1%.
10932272|NCT00720109|FG002|Participant Flow|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
10932273|NCT00720109|OG000|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
10932274|NCT00720109|OG001|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
10932275|NCT00720109|OG002|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
10932276|NCT00720109|OG000|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|Feasibility measured by DLT rates in safety phase, Toxicities define DLTs and are summarized and reviewed to assess feasibility of administering the combination therapy with dasatinib
10932277|NCT00720109|EG000|Reported Event|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
10932278|NCT00720109|EG001|Reported Event|Standard-risk|Based on Minimal Residual Disease, less than 1%.
10932279|NCT00720109|EG002|Reported Event|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
10932280|NCT00720122|BG000|Baseline|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
10932281|NCT00720122|FG000|Participant Flow|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
10932282|NCT00720122|OG000|Outcome|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
10932283|NCT00720122|EG000|Reported Event|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
10932284|NCT00720213|BG000|Baseline|All Study Participants|Participants who signed the informed consent
10932285|NCT00720213|FG000|Participant Flow|Screening Phase|All participants that signed a consent form.
10932286|NCT00720213|FG001|Participant Flow|BiPap Auto SV2 Device First, BiPap Auto SV3 Device Second|BiPAP auto servo ventilation (SV) 2 Device. This arm used the BiPAP AutoSV2 overnight first overnight, followed by the BiPAP auto servo ventilation (SV) 3 Device. This arm used the BiPAP AutoSV3 for the second overnight.
10932287|NCT00720213|FG002|Participant Flow|BiPap Auto SV3 Device First, BiPap AutoSV2 Device Second|BiPAP auto servo ventilation (SV) 3 Device. This arm used the BiPAP AutoSV3 for the first overnight. The second overnight participants used the BiPap Auto Servo Ventilation 2 Device.
10932288|NCT00720213|OG000|Outcome|Respironics BiPAP autoSV2|Respironics BiPAP autoSV2
10932289|NCT00720213|OG001|Outcome|Respironics BiPAP autoSV3|Respironics BiPAP autoSV3
10932290|NCT00720213|OG000|Outcome|Treatment Group 1|Respironics BiPAP autoSV2
10932291|NCT00720213|OG001|Outcome|Treatment Group 2|Respironics BiPAP autoSV3
10932292|NCT00720213|EG000|Reported Event|Treatment Group 1|BiPAP autoSV2 Device
10932293|NCT00720213|EG001|Reported Event|Treatment Group 2|BiPAP autoSV3 Device
10932294|NCT00720226|BG000|Baseline|Losartan|Losartan 100 mg daily
10932295|NCT00720226|BG001|Baseline|Placebo|Placebo 1 tablet daily
10932296|NCT00720226|BG002|Baseline|Total|Total of all reporting groups
10932297|NCT00720226|FG000|Participant Flow|Losartan|"Losartan 100 mg daily~Losartan: Losartan 100 mg daily"
10932298|NCT00720226|FG001|Participant Flow|Placebo|"Placebo 1 pill daily~Placebo: Placebo pill daily"
11175919|NCT02032680|BG000|Baseline|Web-based Family Psycho-education Treatment|"The e-health/web-based intervention provides: three therapist facilitated on-line group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials.~Web-based multi-family psychoeducational treatment: This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters."
10932299|NCT00720226|OG000|Outcome|Losartan|Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)
10932300|NCT00720226|OG001|Outcome|Placebo|Placebo: Placebo pill daily (Participants with 5-35% emphysema)
10932301|NCT00720226|EG000|Reported Event|Losartan 100 mg Daily|"Losartan 100 mg daily~Losartan: Losartan 100 mg daily"
10932302|NCT00720226|EG001|Reported Event|Placebo|"Placebo 1 pill daily~Placebo: Placebo pill daily"
10932303|NCT00720278|BG000|Baseline|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932304|NCT00720278|BG001|Baseline|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932305|NCT00720278|BG002|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932306|NCT00720278|BG003|Baseline|Total|Total of all reporting groups
10932307|NCT00720278|FG000|Participant Flow|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932308|NCT00720278|FG001|Participant Flow|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932309|NCT00720278|FG002|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932310|NCT00720278|OG000|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932311|NCT00720278|OG001|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932312|NCT00720278|OG002|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932313|NCT00720278|EG000|Reported Event|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932314|NCT00720278|EG001|Reported Event|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932315|NCT00720278|EG002|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
10932316|NCT00720330|BG000|Baseline|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
10932317|NCT00720330|BG001|Baseline|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
10932318|NCT00720330|BG002|Baseline|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
10932319|NCT00720330|BG003|Baseline|Total|Total of all reporting groups
10932320|NCT00720330|FG000|Participant Flow|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
11240645|NCT02481141|FG000|Participant Flow|5-ALA-SFC|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks~5-ALA-SFC: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA - SFC"
10932321|NCT00720330|FG001|Participant Flow|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
10932322|NCT00720330|FG002|Participant Flow|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
10932323|NCT00720330|OG000|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
10932324|NCT00720330|OG001|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
10932325|NCT00720330|OG002|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
10932326|NCT00720330|EG000|Reported Event|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
10932327|NCT00720330|EG001|Reported Event|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
10932328|NCT00720330|EG002|Reported Event|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
10932329|NCT00720356|BG000|Baseline|Treatment|"Erlotinib and bevacizumab~Bevacizumab: 10mg/kg administered intravenously every 2 weeks~Erlotinib hydrochloride: 150 mg/daily orally"
10932330|NCT00720356|FG000|Participant Flow|Erlotinib and Bevacizumab Combination Treatment|"Erlotinib and bevacizumab~Bevacizumab: 10mg/kg administered intravenously every 2 weeks~Erlotinib hydrochloride: 150 mg/daily orally"
10932331|NCT00720356|OG000|Outcome|Erlotinib and Bevacizumab Combination Treatment|"Erlotinib and bevacizumab~Bevacizumab: 10mg/kg administered intravenously every 2 weeks~Erlotinib hydrochloride: 150 mg/daily orally"
10932332|NCT00720356|EG000|Reported Event|Erlotinib and Bevacizumab Combination Treatment|"Erlotinib and bevacizumab~Bevacizumab: 10mg/kg administered intravenously every 2 weeks~Erlotinib hydrochloride: 150 mg/daily orally"
10932333|NCT00720369|BG000|Baseline|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
10932334|NCT00720369|BG001|Baseline|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
10932335|NCT00720369|BG002|Baseline|Total|Total of all reporting groups
10932336|NCT00720369|FG000|Participant Flow|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
10932337|NCT00720369|FG001|Participant Flow|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
10932338|NCT00720369|OG000|Outcome|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated.
10932339|NCT00720369|OG001|Outcome|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group.
10932340|NCT00720369|OG000|Outcome|CoQ10|Open Label Study
10932341|NCT00720369|OG001|Outcome|Healthy Controls|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.
11240646|NCT02481141|FG001|Participant Flow|Placebo|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks~Placebo"
10932342|NCT00720369|EG000|Reported Event|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
10932343|NCT00720369|EG001|Reported Event|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
10932344|NCT00720382|BG000|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
10932345|NCT00720382|BG001|Baseline|Nasonex®|Mometasone furoate 200 mcg
10932346|NCT00720382|BG002|Baseline|Total|Total of all reporting groups
10932347|NCT00720382|FG000|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
10932348|NCT00720382|FG001|Participant Flow|Nasonex®|Mometasone furoate 200 mcg
10932349|NCT00720382|OG000|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
10932350|NCT00720382|OG001|Outcome|Nasonex®|Mometasone furoate 200 mcg
10932351|NCT00720382|EG000|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
10932352|NCT00720382|EG001|Reported Event|Nasonex®|Mometasone furoate 200 mcg
10932353|NCT00720434|BG000|Baseline|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
10932354|NCT00720434|BG001|Baseline|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932355|NCT00720434|BG002|Baseline|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932356|NCT00720434|BG003|Baseline|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932357|NCT00720434|BG004|Baseline|Total|Total of all reporting groups
10932358|NCT00720434|FG000|Participant Flow|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
10932359|NCT00720434|FG001|Participant Flow|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932360|NCT00720434|FG002|Participant Flow|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932361|NCT00720434|FG003|Participant Flow|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932362|NCT00720434|OG000|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
10932363|NCT00720434|OG001|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932364|NCT00720434|OG002|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932365|NCT00720434|OG003|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932366|NCT00720434|EG000|Reported Event|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
10932367|NCT00720434|EG001|Reported Event|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932368|NCT00720434|EG002|Reported Event|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932369|NCT00720434|EG003|Reported Event|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
10932370|NCT00720473|BG000|Baseline|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
10932371|NCT00720473|BG001|Baseline|Control Subjects|Age matched controls without BPD
10932372|NCT00720473|BG002|Baseline|Total|Total of all reporting groups
10932373|NCT00720473|FG000|Participant Flow|A: BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
10932374|NCT00720473|FG001|Participant Flow|B: Healthy Control|No Intervention
10932375|NCT00720473|OG000|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
10932376|NCT00720473|OG001|Outcome|Control Subjects|Age matched controls without BPD
10932377|NCT00720473|OG000|Outcome|A: Other|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
10932378|NCT00720473|EG000|Reported Event|Control Subjects|Age matched controls without BPD
10932379|NCT00720473|EG001|Reported Event|BPD Subjects|
10932380|NCT00720499|BG000|Baseline|Overall Study|"A randomised, double-blind, 2-way cross-over study. The two treatment periods were separated by a wash-out period of 14 days during which they received open-label Tiotropium 5 mcg. The 2 treatments, administered once daily in the morning via the respimat inhaler, were :~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
10932381|NCT00720499|FG000|Participant Flow|Tio+Olo 5/2µg / Tio+Olo5/5µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg.~Both treatments were administered once daily in the morning via the respimat inhaler."
10932382|NCT00720499|FG001|Participant Flow|Tio+Olo5/5µg / Tio+Olo5/2µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg.~Both treatments were administered once daily in the morning via the respimat inhaler."
10932383|NCT00720499|OG000|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10932384|NCT00720499|OG001|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10932385|NCT00720499|OG001|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10932386|NCT00720499|EG000|Reported Event|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10932387|NCT00720499|EG001|Reported Event|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
10932388|NCT00720629|BG000|Baseline|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
10932389|NCT00720629|FG000|Participant Flow|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
10932390|NCT00720629|OG000|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
10932391|NCT00720629|OG000|Outcome|2 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
10932392|NCT00720629|OG001|Outcome|5 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
10932393|NCT00720629|EG000|Reported Event|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
10932394|NCT00720759|BG000|Baseline|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
10932395|NCT00720759|BG001|Baseline|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
10932396|NCT00720759|BG002|Baseline|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
10932397|NCT00720759|BG003|Baseline|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
10932398|NCT00720759|BG004|Baseline|Total|Total of all reporting groups
10932399|NCT00720759|FG000|Participant Flow|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
10932400|NCT00720759|FG001|Participant Flow|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
10932401|NCT00720759|FG002|Participant Flow|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
10932402|NCT00720759|FG003|Participant Flow|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
10932403|NCT00720759|OG000|Outcome|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
10932404|NCT00720759|OG001|Outcome|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
10932405|NCT00720759|OG002|Outcome|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
10932406|NCT00720759|OG003|Outcome|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
10932407|NCT00720759|EG000|Reported Event|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
10932408|NCT00720759|EG001|Reported Event|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
10932409|NCT00720759|EG002|Reported Event|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
10932410|NCT00720759|EG003|Reported Event|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
10932411|NCT00720798|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
10932412|NCT00720798|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
10932413|NCT00720798|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
10932414|NCT00720798|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
10932415|NCT00720876|BG000|Baseline|Vorinostat and Rituximab|"Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .~rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.~vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle."
10932416|NCT00720876|FG000|Participant Flow|Vorinostat and Rituximab|"Vorinostat by mouth two times (2X) per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .~rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.~vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle."
10932417|NCT00720876|OG000|Outcome|Vorinostat and Rituximab|"Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .~rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.~vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle."
10932418|NCT00720876|EG000|Reported Event|Vorinostat and Rituximab|"Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .~rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.~vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle."
10932419|NCT00720941|BG000|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
10932420|NCT00720941|BG001|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
10932421|NCT00720941|BG002|Baseline|Total|Total of all reporting groups
10932422|NCT00720941|FG000|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
10932423|NCT00720941|FG001|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
10932424|NCT00720941|OG000|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
10932425|NCT00720941|OG001|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
10932426|NCT00720941|EG000|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
10932427|NCT00720941|EG001|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
10963336|NCT00871572|FG002|Participant Flow|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
10932428|NCT00721110|BG000|Baseline|Lidocaine/Ketamine|"Intravenous Lidocaine and Ketamine Group -~Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters."
10932429|NCT00721110|BG001|Baseline|Lidocaine|"Intravenous lidocaine Group - A lidocaine is administered intravenously through out surgery and 24 hours after surgery.~Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours."
10932430|NCT00721110|BG002|Baseline|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
10932431|NCT00721110|BG003|Baseline|Placebo|"A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine or Lidocaine not given"
10932432|NCT00721110|BG004|Baseline|Total|Total of all reporting groups
10932433|NCT00721110|FG000|Participant Flow|Lidocaine/Ketamine|"Intravenous Lidocaine + Ketamine Group~Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.~Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours.~Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters"
10932434|NCT00721110|FG001|Participant Flow|Lidocaine|Intravenous lidocaine Group - Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
10932435|NCT00721110|FG002|Participant Flow|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
10932436|NCT00721110|FG003|Participant Flow|Placebo|"A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine or lidocaine not given"
10932437|NCT00721110|OG000|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery~Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
10932438|NCT00721110|OG001|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.~Placebo boluses and infusions will be substituted for the lidocaine"
10932439|NCT00721110|OG002|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
10932440|NCT00721110|OG003|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine not given"
11240647|NCT02481141|OG000|Outcome|5-ALA-SFC Through Week 2 (50 mg 2x/Day)|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks"
10932441|NCT00721110|EG000|Reported Event|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery~Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
10932442|NCT00721110|EG001|Reported Event|Placebo|placebo is administered intravenously through out surgery and 24 hours after surgery.
10932443|NCT00721110|EG002|Reported Event|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
10932444|NCT00721110|EG003|Reported Event|Ketamine + Lidocaine|both ketamine and Lidocaine administered intravenously throughout surgery and during the 24 hours after surgery.
10932445|NCT00721123|BG000|Baseline|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10932446|NCT00721123|FG000|Participant Flow|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
10932447|NCT00721123|OG000|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48.
10932448|NCT00721123|OG001|Outcome|Months 13 - 24|Participants with scores during Months 13 - 24, which equates to Weeks 49-96.
10932449|NCT00721123|OG002|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144.
10932450|NCT00721123|OG003|Outcome|Months 37 - 48|Participants with scores during Months 37 - 48, which equates to Weeks 145-192.
10932451|NCT00721123|OG004|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264.
10932452|NCT00721123|OG000|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
10932453|NCT00721123|OG001|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
10932454|NCT00721123|OG002|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
10932455|NCT00721123|OG003|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
10932456|NCT00721123|OG004|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
10932457|NCT00721123|OG005|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
10932458|NCT00721123|OG000|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48 (Total PY=486.34).
10932459|NCT00721123|OG001|Outcome|Months 13 - 24|Participants with scores during Months 13 - 24, which equates to Weeks 49-96 (Total PY=444.49).
10932460|NCT00721123|OG002|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144 (Total PY=410.93).
10932461|NCT00721123|OG003|Outcome|Months 37 - 48|Participants with scores during Months 37 - 48, which equates to Weeks 145-192 (Total PY=388.25).
10932462|NCT00721123|OG004|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264 (Total PY=731.93).
10932463|NCT00721123|OG000|Outcome|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
10932464|NCT00721123|EG000|Reported Event|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
10932465|NCT00721136|BG000|Baseline|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932466|NCT00721136|BG001|Baseline|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
10932467|NCT00721136|BG002|Baseline|High Risk Continuing Warfarin|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue coumadin at the usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932468|NCT00721136|BG003|Baseline|High Risk Holding Warfarin|These high risk patients randomized to holding coumadin for 4-5 days and using a heparin transition for bridging.
10932469|NCT00721136|BG004|Baseline|Total|Total of all reporting groups
10932470|NCT00721136|FG000|Participant Flow|Moderate Risk Continuing Warfarin (Coumadin)|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932471|NCT00721136|FG001|Participant Flow|Moderate Risk Holding Warfarin (Coumadin)|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
10932472|NCT00721136|FG002|Participant Flow|High Risk Continuing Warfarin (Coumadin)|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932473|NCT00721136|FG003|Participant Flow|High Risk Holding Warfarin (Coumadin)|These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
10932474|NCT00721136|OG000|Outcome|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure:The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932475|NCT00721136|OG001|Outcome|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
10932476|NCT00721136|OG002|Outcome|High Risk Continuing Warfarin|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.~These patients continue warfarin through the procedure: The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932477|NCT00721136|OG003|Outcome|High Risk Holding Warfarin|These high risk patients randomized to holding warfarin for 4-
10932478|NCT00721136|OG000|Outcome|Moderate Risk Continuing Warfarin (Coumadin)|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932479|NCT00721136|OG001|Outcome|Moderate Risk Holding Warfarin (Coumadin)|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
10932480|NCT00721136|OG002|Outcome|High Risk Continuing Warfarin (Coumadin)|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932481|NCT00721136|OG003|Outcome|High Risk Holding Warfarin (Coumadin)|These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
10963337|NCT00871572|FG003|Participant Flow|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
10932482|NCT00721136|EG000|Reported Event|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
10932483|NCT00721136|EG001|Reported Event|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
10932484|NCT00721136|EG002|Reported Event|High Risk Continuing Warfarin|High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
10932485|NCT00721136|EG003|Reported Event|High Risk Holding Warfarin|"These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.~These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging."
10932486|NCT00721149|BG000|Baseline|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
10932487|NCT00721149|FG000|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
10932488|NCT00721149|OG000|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
10932489|NCT00721149|EG000|Reported Event|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
11175920|NCT02032680|BG001|Baseline|In-persons Multi-family Psycho-educational Treatment|"This arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group (MFG) that is the standard of care in the VA.~In-persons multi-family psycho-educational treatment: This intervention will provide the VA's evidence-based, in-person delivered, multi-family psychoeducational treatment, termed Multi-Family group (MFG). This intervention is delivered to Veterans and their families or other supporters using an in-person format."
10932490|NCT00721162|BG000|Baseline|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
10932491|NCT00721162|FG000|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
10932492|NCT00721162|OG000|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
10932493|NCT00721162|EG000|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
10932494|NCT00721175|BG000|Baseline|SEMS|self-expandable metal stent group
10932495|NCT00721175|BG001|Baseline|Plastic Stent|plastic stent group
10932496|NCT00721175|BG002|Baseline|Total|Total of all reporting groups
10932497|NCT00721175|FG000|Participant Flow|SEMS|self-expandable metal stent group
10932498|NCT00721175|FG001|Participant Flow|Plastic Stent|plastic stent group
10932499|NCT00721175|OG000|Outcome|SEMS|SEMS (Self-expandable metal stent group)
10932500|NCT00721175|OG001|Outcome|Plastic Stent|Plastic stent group
10932501|NCT00721175|EG000|Reported Event|SEMS|self-expandable metal stent group
10932502|NCT00721175|EG001|Reported Event|Plastic Stent|plastic stent group
10932503|NCT00721188|BG000|Baseline|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
10932504|NCT00721188|FG000|Participant Flow|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
10932505|NCT00721188|OG000|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
10932506|NCT00721188|EG000|Reported Event|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
10932507|NCT00721214|BG000|Baseline|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
10932508|NCT00721214|FG000|Participant Flow|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
10932509|NCT00721214|OG000|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
10963338|NCT00871572|OG000|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
10932510|NCT00721214|EG000|Reported Event|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
10932511|NCT00721227|BG000|Baseline|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
10932512|NCT00721227|BG001|Baseline|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
10932513|NCT00721227|BG002|Baseline|Total|Total of all reporting groups
10932514|NCT00721227|FG000|Participant Flow|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
10932515|NCT00721227|FG001|Participant Flow|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
10932516|NCT00721227|OG000|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
10932517|NCT00721227|OG001|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
10932518|NCT00721227|EG000|Reported Event|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
10932519|NCT00721227|EG001|Reported Event|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
10932520|NCT00721253|BG000|Baseline|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
10932521|NCT00721253|BG001|Baseline|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
10932522|NCT00721253|BG002|Baseline|Total|Total of all reporting groups
10932523|NCT00721253|FG000|Participant Flow|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
10932524|NCT00721253|FG001|Participant Flow|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
10932525|NCT00721253|FG002|Participant Flow|Tecnis MF|Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
10932526|NCT00721253|OG000|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
10932527|NCT00721253|OG001|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
10932528|NCT00721253|EG000|Reported Event|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
10932529|NCT00721253|EG001|Reported Event|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
11175921|NCT02032680|BG002|Baseline|Total|Total of all reporting groups
11240648|NCT02481141|OG001|Outcome|5-ALA-SFC Through Week 4 (75 mg 2x/Day)|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
10932530|NCT00721279|BG000|Baseline|De-novo Patients|Patients that had not been treated for RLS at baseline
10932531|NCT00721279|BG001|Baseline|Pre-treated Patients|Patients that had been treated for RLS at baseline
10932532|NCT00721279|BG002|Baseline|Total|Total of all reporting groups
10932533|NCT00721279|FG000|Participant Flow|De-novo Patients|Patients that had not been treated for RLS at baseline
10932534|NCT00721279|FG001|Participant Flow|Pre-treated Patients|Patients that had been treated for RLS at baseline
10932535|NCT00721279|OG000|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
10932536|NCT00721279|OG001|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
10932537|NCT00721279|OG000|Outcome|Overall|All Patients
10932538|NCT00721279|EG000|Reported Event|De-novo Patients|Patients that had not been treated for RLS at baseline
10932539|NCT00721279|EG001|Reported Event|Pre-treated Patients|Patients that had been treated for RLS at baseline
10932540|NCT00721357|BG000|Baseline|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932541|NCT00721357|BG001|Baseline|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932542|NCT00721357|BG002|Baseline|Total|Total of all reporting groups
10932543|NCT00721357|FG000|Participant Flow|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932544|NCT00721357|FG001|Participant Flow|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932545|NCT00721357|OG000|Outcome|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932546|NCT00721357|OG001|Outcome|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932547|NCT00721357|OG000|Outcome|Stroke|"Stroke subjects~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932548|NCT00721357|OG001|Outcome|Control|"neurologically healthy subjects~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
11175922|NCT02032680|FG000|Participant Flow|Web-based Family Psycho-education Treatment|"The e-health/web-based intervention provides: three therapist facilitated group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials.~Web-based multi-family psychoeducational treatment: This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters."
11240649|NCT02481141|OG002|Outcome|5-ALA-SFC Through Week 12 (100 mg 2x/Day)|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
10932549|NCT00721357|EG000|Reported Event|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932550|NCT00721357|EG001|Reported Event|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
10932551|NCT00721396|BG000|Baseline|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
10932552|NCT00721396|BG001|Baseline|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
10932553|NCT00721396|BG002|Baseline|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
10932554|NCT00721396|BG003|Baseline|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
10932555|NCT00721396|BG004|Baseline|Total|Total of all reporting groups
10932556|NCT00721396|FG000|Participant Flow|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
11240650|NCT02481141|OG003|Outcome|Placebo Through Week 2|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks"
10932557|NCT00721396|FG001|Participant Flow|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
10932558|NCT00721396|FG002|Participant Flow|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
10932559|NCT00721396|FG003|Participant Flow|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
10932560|NCT00721396|OG000|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
10932561|NCT00721396|OG001|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
10932562|NCT00721396|OG002|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
10932563|NCT00721396|OG003|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
10932564|NCT00721396|OG000|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations.
10932565|NCT00721396|OG001|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age.
10932566|NCT00721396|OG002|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.
10932567|NCT00721396|OG000|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
10932568|NCT00721396|OG001|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
11240651|NCT02481141|OG004|Outcome|Placebo Through Week 4|"Study matching placebo administration will be as follows:~Beginning Week 2: 1 capsule twice per day for 2 weeks"
10932569|NCT00721396|EG000|Reported Event|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
10932570|NCT00721396|EG001|Reported Event|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
10932571|NCT00721396|EG002|Reported Event|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
10932572|NCT00721396|EG003|Reported Event|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
10932573|NCT00721409|BG000|Baseline|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
10932574|NCT00721409|BG001|Baseline|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
10932575|NCT00721409|BG002|Baseline|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
10932576|NCT00721409|BG003|Baseline|Total|Total of all reporting groups
10932577|NCT00721409|FG000|Participant Flow|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
10932578|NCT00721409|FG001|Participant Flow|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
10932579|NCT00721409|FG002|Participant Flow|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
10932580|NCT00721409|OG000|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
10932581|NCT00721409|OG000|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
10932582|NCT00721409|OG001|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
10932583|NCT00721409|OG002|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive Letrozole plus Palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and Letrozole 2.5 mg/d orally in a continuous regimen.
11175923|NCT02032680|FG001|Participant Flow|In-persons Multi-family Psycho-educational Treatment|"This arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group (MFG) that is the standard of care in the VA.~In-persons multi-family psycho-educational treatment: This intervention will provide the VA's evidence-based, in-person delivered, multi-family psychoeducational treatment, termed Multi-Family group (MFG). This intervention is delivered to Veterans and their families or other supporters using an in-person format."
11175924|NCT02032680|OG000|Outcome|Web-based Family Psycho-education Treatment|"The e-health/web-based intervention provides: three therapist facilitated group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials.~Web-based multi-family psychoeducational treatment: This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters."
11175925|NCT02032680|OG001|Outcome|In-persons Multi-family Psycho-educational Treatment|"This arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group (MFG) that is the standard of care in the VA.~In-persons multi-family psycho-educational treatment: This intervention will provide the VA's evidence-based, in-person delivered, multi-family psychoeducational treatment, termed Multi-Family group (MFG). This intervention is delivered to Veterans and their families or other supporters using an in-person format."
11175926|NCT02032680|EG000|Reported Event|Web-based Family Psycho-education Treatment|"The e-health/web-based intervention provides: three therapist facilitated group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials.~Web-based multi-family psychoeducational treatment: This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters."
11175927|NCT02032680|EG001|Reported Event|In-persons Multi-family Psycho-educational Treatment|"This arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group (MFG) that is the standard of care in the VA.~In-persons multi-family psycho-educational treatment: This intervention will provide the VA's evidence-based, in-person delivered, multi-family psychoeducational treatment, termed Multi-Family group (MFG). This intervention is delivered to Veterans and their families or other supporters using an in-person format."
10932584|NCT00721409|OG003|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive Letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
10932585|NCT00721409|OG004|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive Letrozole plus Palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and Letrozole 2.5 mg/d orally in a continuous regimen.
10932586|NCT00721409|OG005|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive Letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
11175928|NCT02032706|BG000|Baseline|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
11175929|NCT02032706|FG000|Participant Flow|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
11175930|NCT02032706|OG000|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
11175931|NCT02032706|EG000|Reported Event|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
11175932|NCT02032758|BG000|Baseline|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
11240652|NCT02481141|OG005|Outcome|Placebo Through Week 12|"Study matching placebo administration will be as follows:~Beginning Week 4: 1 capsule twice per day for 8 weeks"
10932587|NCT00721409|OG000|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
10932588|NCT00721409|OG001|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
10932589|NCT00721409|OG000|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
10932590|NCT00721409|OG001|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
10932591|NCT00721409|OG000|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive Letrozole plus Palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and Letrozole 2.5 mg/d orally in a continuous regimen.
10932592|NCT00721409|OG001|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive Letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
10932593|NCT00721409|OG002|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive Letrozole plus Palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and Letrozole 2.5 mg/d orally in a continuous regimen.
10932594|NCT00721409|OG003|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive Letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
10932595|NCT00721409|EG000|Reported Event|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
10932596|NCT00721409|EG001|Reported Event|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
10932597|NCT00721409|EG002|Reported Event|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
10932598|NCT00721409|EG003|Reported Event|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive Letrozole plus Palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and Letrozole 2.5 mg/d orally in a continuous regimen.
10932599|NCT00721409|EG004|Reported Event|Ph2P1 (Letrozole)|Participants were randomized to receive Letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
10932600|NCT00721409|EG005|Reported Event|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive Letrozole plus Palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and Letrozole 2.5 mg/d orally in a continuous regimen.
10932601|NCT00721409|EG006|Reported Event|Ph2P2 (Letrozole)|Participants were randomized to receive Letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
11175933|NCT02032758|BG001|Baseline|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
10932602|NCT00721500|BG000|Baseline|All Subjects|All subjects who enrolled and completed study.
10932603|NCT00721500|FG000|Participant Flow|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
10932604|NCT00721500|FG001|Participant Flow|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
10932605|NCT00721500|FG002|Participant Flow|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
10932606|NCT00721500|FG003|Participant Flow|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
10932607|NCT00721500|OG000|Outcome|Narafilcon A (Bilateral)|narafilcon A contact lens worn in both eyes.
10932608|NCT00721500|OG001|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
10932609|NCT00721500|OG002|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
10932610|NCT00721500|OG003|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
10932611|NCT00721500|OG000|Outcome|Narafilcon A|Narafilcon A contact lens worn in both eyes.
10932612|NCT00721500|OG000|Outcome|Narafilcon A (Bilateral)|Narafilcon A contact lens worn in both eyes.
10932613|NCT00721500|EG000|Reported Event|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
10932614|NCT00721500|EG001|Reported Event|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
10932615|NCT00721500|EG002|Reported Event|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
10932616|NCT00721500|EG003|Reported Event|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
10932617|NCT00721513|BG000|Baseline|TPFChemotherapy + Concomitant Cetuximab & RT|"Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy~cetuximab~cisplatin~docetaxel~fluorouracil~computed tomography~positron emission tomography~quality-of-life assessment~3-dimensional conformal radiation therapy~intensity-modulated radiation therapy"
10932618|NCT00721513|FG000|Participant Flow|TPFChemotherapy + Concomitant Cetuximab & RT|"Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy~cetuximab~cisplatin~docetaxel~fluorouracil~computed tomography~positron emission tomography~quality-of-life assessment~3-dimensional conformal radiation therapy~intensity-modulated radiation therapy"
10932619|NCT00721513|OG000|Outcome|TPFChemotherapy + Concomitant Cetuximab & RT|"Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy~cetuximab~cisplatin~docetaxel~fluorouracil~computed tomography~positron emission tomography~quality-of-life assessment~3-dimensional conformal radiation therapy~intensity-modulated radiation therapy"
10932620|NCT00721513|EG000|Reported Event|TPFChemotherapy + Concomitant Cetuximab & RT|"Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy~cetuximab~cisplatin~docetaxel~fluorouracil~computed tomography~positron emission tomography~quality-of-life assessment~3-dimensional conformal radiation therapy~intensity-modulated radiation therapy"
10932621|NCT00721539|BG000|Baseline|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
10932622|NCT00721539|FG000|Participant Flow|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
10932623|NCT00721539|OG000|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
10932624|NCT00721539|EG000|Reported Event|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
10932625|NCT00721578|BG000|Baseline|Entire Study Population|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
10932626|NCT00721578|FG000|Participant Flow|Voriconazole Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
11175934|NCT02032758|BG002|Baseline|Total|Total of all reporting groups
10932627|NCT00721578|FG001|Participant Flow|Other Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
10932628|NCT00721578|OG000|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
10932629|NCT00721578|OG000|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
10932630|NCT00721578|OG000|Outcome|Therapy for Systemic Fungal Infection|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
10932631|NCT00721578|EG000|Reported Event|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
10932632|NCT00721617|BG000|Baseline|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h.
10932633|NCT00721617|FG000|Participant Flow|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
10932634|NCT00721617|OG000|Outcome|Healthy Subjects|Subjects received either IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) in a random order.
10932635|NCT00721617|OG000|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
10932636|NCT00721617|EG000|Reported Event|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
11175935|NCT02032758|FG000|Participant Flow|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
10932637|NCT00721630|BG000|Baseline|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
10932638|NCT00721630|FG000|Participant Flow|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
10932639|NCT00721630|OG000|Outcome|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
10932640|NCT00721630|EG000|Reported Event|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
10932641|NCT00721734|BG000|Baseline|Carfilzomib - Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932642|NCT00721734|BG001|Baseline|Carfilzomib - Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932643|NCT00721734|BG002|Baseline|Carfilzomib - Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932644|NCT00721734|BG003|Baseline|Carfilzomib - Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932645|NCT00721734|BG004|Baseline|Carfilzomib - Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
11240653|NCT02481141|OG000|Outcome|5-ALA-SFC Through Week 2 (50 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks"
10932646|NCT00721734|BG005|Baseline|Total|Total of all reporting groups
10932647|NCT00721734|FG000|Participant Flow|Carfilzomib - Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932648|NCT00721734|FG001|Participant Flow|Carfilzomib - Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10963339|NCT00871572|OG001|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
10963340|NCT00871572|OG002|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
10932649|NCT00721734|FG002|Participant Flow|Carfilzomib - Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932650|NCT00721734|FG003|Participant Flow|Carfilzomib - Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932651|NCT00721734|FG004|Participant Flow|Carfilzomib - Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932652|NCT00721734|OG000|Outcome|Carfilzomib - Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932653|NCT00721734|OG001|Outcome|Carfilzomib - Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932654|NCT00721734|OG002|Outcome|Carfilzomib - Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932655|NCT00721734|OG003|Outcome|Carfilzomib - Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932656|NCT00721734|OG004|Outcome|Carfilzomib - Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932657|NCT00721734|EG000|Reported Event|Carfilzomib - Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932658|NCT00721734|EG001|Reported Event|Carfilzomib - Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
11175936|NCT02032758|FG001|Participant Flow|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
10932659|NCT00721734|EG002|Reported Event|Carfilzomib - Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932660|NCT00721734|EG003|Reported Event|Carfilzomib - Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932661|NCT00721734|EG004|Reported Event|Carfilzomib - Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
10932662|NCT00721799|BG000|Baseline|FLT PET|"Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.~F-18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]"
10932663|NCT00721799|FG000|Participant Flow|FLT PET|"Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.~F-18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]"
10963341|NCT00871572|OG003|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
10963342|NCT00871572|EG000|Reported Event|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
10932664|NCT00721799|OG000|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
10932665|NCT00721799|EG000|Reported Event|FLT PET|"Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.~F-18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]"
10932666|NCT00721955|BG000|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
10932667|NCT00721955|BG001|Baseline|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
10932668|NCT00721955|BG002|Baseline|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
10932669|NCT00721955|BG003|Baseline|Total|Total of all reporting groups
10932670|NCT00721955|FG000|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
10932671|NCT00721955|FG001|Participant Flow|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
10932672|NCT00721955|FG002|Participant Flow|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
10932673|NCT00721955|OG000|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
10932674|NCT00721955|OG001|Outcome|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
10932675|NCT00721955|OG002|Outcome|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
10932676|NCT00721955|EG000|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
10932677|NCT00721955|EG001|Reported Event|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
10932678|NCT00721955|EG002|Reported Event|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
10932679|NCT00721968|BG000|Baseline|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
10932680|NCT00721968|BG001|Baseline|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
10932681|NCT00721968|BG002|Baseline|Total|Total of all reporting groups
10932682|NCT00721968|FG000|Participant Flow|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
10932683|NCT00721968|FG001|Participant Flow|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
10932684|NCT00721968|OG000|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
10932685|NCT00721968|OG001|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
10932686|NCT00721968|EG000|Reported Event|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
10932687|NCT00721968|EG001|Reported Event|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
10932688|NCT00722007|BG000|Baseline|Cormet Hip Resurfacing Post-PMA Group|Cormet Resurfacing Hip System implanted after pre-market approval
10932689|NCT00722007|FG000|Participant Flow|Post-PMA Study|Implanted with Cormet Hip Resurfacing System after pre-market approval.
10932690|NCT00722007|OG000|Outcome|Cormet Hip Resurfacing Post-PMA Group|
10932691|NCT00722007|OG000|Outcome|Cormet Hip Resurfacing Post-PMA Group|"hip resurfacing~Cormet Hip Resurfacing: Cormet Hip Resurfacing implant"
10932692|NCT00722007|EG000|Reported Event|Cormet Hip Resurfacing Post-PMA Group|
10932693|NCT00722020|BG000|Baseline|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
10932694|NCT00722020|BG001|Baseline|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
10932695|NCT00722020|BG002|Baseline|Total|Total of all reporting groups
10932696|NCT00722020|FG000|Participant Flow|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.~High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
10932697|NCT00722020|FG001|Participant Flow|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.~Regular nebulized bronchodilator treatment.: Sham Vest treatment."
10932698|NCT00722020|OG000|Outcome|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.~High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
10932699|NCT00722020|OG001|Outcome|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.~Regular nebulized bronchodilator treatment.: Sham Vest treatment."
10932700|NCT00722020|OG000|Outcome|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
10932701|NCT00722020|OG001|Outcome|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
10932702|NCT00722020|EG000|Reported Event|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
10932703|NCT00722020|EG001|Reported Event|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
10932704|NCT00722072|BG000|Baseline|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
10932705|NCT00722072|FG000|Participant Flow|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
10932706|NCT00722072|OG000|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
10932707|NCT00722072|EG000|Reported Event|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
11175937|NCT02032758|OG000|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
11175938|NCT02032758|OG001|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
11175939|NCT02032758|EG000|Reported Event|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
11175940|NCT02032758|EG001|Reported Event|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
11175941|NCT02032875|BG000|Baseline|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
11175942|NCT02032875|BG001|Baseline|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
11175943|NCT02032875|BG002|Baseline|Total|Total of all reporting groups
10932708|NCT00722111|BG000|Baseline|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
10932709|NCT00722111|BG001|Baseline|Lingual Pressure Norms|Normative values for lingual pressures
10932710|NCT00722111|BG002|Baseline|Total|Total of all reporting groups
10932711|NCT00722111|FG000|Participant Flow|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
10932712|NCT00722111|FG001|Participant Flow|Lingual Pressure Norms|Normative values for lingual pressures
10932713|NCT00722111|OG000|Outcome|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
10932714|NCT00722111|OG001|Outcome|Lingual Pressure Norms|Normative values for lingual pressures
10932715|NCT00722111|EG000|Reported Event|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
10932716|NCT00722111|EG001|Reported Event|Lingual Pressure Norms|Normative values for lingual pressures
10932717|NCT00722124|BG000|Baseline|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
10932718|NCT00722124|BG001|Baseline|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
10932719|NCT00722124|BG002|Baseline|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
10932720|NCT00722124|BG003|Baseline|Total|Total of all reporting groups
10932721|NCT00722124|FG000|Participant Flow|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
10932722|NCT00722124|FG001|Participant Flow|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
11175944|NCT02032875|FG000|Participant Flow|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
11175945|NCT02032875|FG001|Participant Flow|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
10932723|NCT00722124|FG002|Participant Flow|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
10932724|NCT00722124|OG000|Outcome|SAMe 800|
10932725|NCT00722124|OG001|Outcome|SAMe 1600|
10932726|NCT00722124|OG002|Outcome|Placebo|
10932727|NCT00722124|EG000|Reported Event|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
10932728|NCT00722124|EG001|Reported Event|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
10932729|NCT00722124|EG002|Reported Event|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
10932730|NCT00722137|BG000|Baseline|R-CHOP|Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
10932731|NCT00722137|BG001|Baseline|VcR-CAP|Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
10932732|NCT00722137|BG002|Baseline|Total|Total of all reporting groups
10932733|NCT00722137|FG000|Participant Flow|R-CHOP|Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
10932734|NCT00722137|FG001|Participant Flow|VcR-CAP|Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
10932735|NCT00722137|OG000|Outcome|R-CHOP|Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
10932736|NCT00722137|OG001|Outcome|VcR-CAP|Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
10932737|NCT00722137|EG000|Reported Event|R-CHOP|Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
10932738|NCT00722137|EG001|Reported Event|VcR-CAP|Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
10932739|NCT00722371|BG000|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
10932740|NCT00722371|BG001|Baseline|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932741|NCT00722371|BG002|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
11240654|NCT02481141|OG001|Outcome|5-ALA-SFC Through Week 4 (75 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
11240655|NCT02481141|OG002|Outcome|5-ALA-SFC Through Wk 12 (100 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks"
10932742|NCT00722371|BG003|Baseline|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932743|NCT00722371|BG004|Baseline|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
10932744|NCT00722371|BG005|Baseline|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
10932745|NCT00722371|BG006|Baseline|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
10932746|NCT00722371|BG007|Baseline|Total|Total of all reporting groups
10932747|NCT00722371|FG000|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
10932748|NCT00722371|FG001|Participant Flow|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932749|NCT00722371|FG002|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932750|NCT00722371|FG003|Participant Flow|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932751|NCT00722371|FG004|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
10932752|NCT00722371|FG005|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
11240656|NCT02481141|OG003|Outcome|Placebo Through Week 2 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks"
10932753|NCT00722371|FG006|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
10932754|NCT00722371|OG000|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
10932755|NCT00722371|OG001|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932756|NCT00722371|OG002|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932757|NCT00722371|OG003|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932758|NCT00722371|OG004|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
10932759|NCT00722371|OG005|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
10932760|NCT00722371|OG006|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
10932761|NCT00722371|EG000|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
10932762|NCT00722371|EG001|Reported Event|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932763|NCT00722371|EG002|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932764|NCT00722371|EG003|Reported Event|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
10932765|NCT00722371|EG004|Reported Event|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
10932766|NCT00722371|EG005|Reported Event|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
11240657|NCT02481141|OG004|Outcome|Placebo Through Week 4 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 2: 1 capsule twice per day for 2 weeks"
10932767|NCT00722371|EG006|Reported Event|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
10932768|NCT00722423|BG000|Baseline|Integrated Care Model|Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.
10932769|NCT00722423|BG001|Baseline|Usucal Care Model|
10932770|NCT00722423|BG002|Baseline|Total|Total of all reporting groups
10932771|NCT00722423|FG000|Participant Flow|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
10932772|NCT00722423|FG001|Participant Flow|Usual Care Model|"Patients randomized to usual care (UC) received standard of care required for HCV patients consistent with current VA treatment guidelines and clinic structures."
10932773|NCT00722423|OG000|Outcome|Integrated Care Model|"integrated care~Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals."
10932774|NCT00722423|OG001|Outcome|Usual Care Model|"usual care~Patients receive care as usual in their HCV clinic. This care does not include the co-located mental health provider."
11240658|NCT02481141|OG005|Outcome|Placebo Through Week 12 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 4: 1 capsule twice per day for 8 weeks"
10932775|NCT00722423|OG000|Outcome|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
10932776|NCT00722423|OG001|Outcome|Usual Care Model|"Patients randomized to usual care (UC) received standard of care required for HCV patients consistent with current VA treatment guidelines and clinic structures."
10932777|NCT00722423|EG000|Reported Event|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
10932778|NCT00722423|EG001|Reported Event|Usual Care Model|"Patients randomized to usual care (UC) received standard of care required for HCV patients consistent with current VA treatment guidelines and clinic structures."
10932779|NCT00722436|BG000|Baseline|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
10932780|NCT00722436|BG001|Baseline|Placebo|"Saline~saline: Placebo"
10932781|NCT00722436|BG002|Baseline|Total|Total of all reporting groups
11240659|NCT02481141|OG002|Outcome|5-ALA-SFC Through Week 12 (100 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks"
10932782|NCT00722436|FG000|Participant Flow|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
10932783|NCT00722436|FG001|Participant Flow|Placebo|"Saline~saline: Placebo"
10932784|NCT00722436|OG000|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
10932785|NCT00722436|OG001|Outcome|Placebo|"Saline~saline: Placebo"
10932786|NCT00722436|EG000|Reported Event|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
11240660|NCT02481141|OG000|Outcome|5-ALA-SFC Through Week 6 Change From Baseline|Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
10932787|NCT00722436|EG001|Reported Event|Placebo|"Saline~saline: Placebo"
10932788|NCT00722553|BG000|Baseline|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
10932789|NCT00722553|FG000|Participant Flow|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
10932790|NCT00722553|OG000|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed transitional cell carcinoma (TCC) (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
10932791|NCT00722553|OG000|Outcome|Evaluable Patients|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
10932792|NCT00722553|OG000|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
10932793|NCT00722553|EG000|Reported Event|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
10932794|NCT00722566|BG000|Baseline|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932795|NCT00722566|BG001|Baseline|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932796|NCT00722566|BG002|Baseline|Total|Total of all reporting groups
10932797|NCT00722566|FG000|Participant Flow|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932798|NCT00722566|FG001|Participant Flow|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932799|NCT00722566|OG000|Outcome|VELCADE Subcutaneuous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932800|NCT00722566|OG001|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932801|NCT00722566|OG000|Outcome|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932802|NCT00722566|OG001|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932803|NCT00722566|EG000|Reported Event|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932804|NCT00722566|EG001|Reported Event|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
10932805|NCT00722722|BG000|Baseline|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932806|NCT00722722|BG001|Baseline|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932807|NCT00722722|BG002|Baseline|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932808|NCT00722722|BG003|Baseline|Total|Total of all reporting groups
10932809|NCT00722722|FG000|Participant Flow|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932810|NCT00722722|FG001|Participant Flow|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932811|NCT00722722|FG002|Participant Flow|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932812|NCT00722722|OG000|Outcome|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932813|NCT00722722|OG001|Outcome|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932814|NCT00722722|OG002|Outcome|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932815|NCT00722722|EG000|Reported Event|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932816|NCT00722722|EG001|Reported Event|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932817|NCT00722722|EG002|Reported Event|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
10932818|NCT00722761|BG000|Baseline|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
10932819|NCT00722761|BG001|Baseline|Placebo Tablet|Placebo tablet once a day
10932820|NCT00722761|BG002|Baseline|Total|Total of all reporting groups
10932821|NCT00722761|FG000|Participant Flow|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
10932822|NCT00722761|FG001|Participant Flow|Placebo Tablet|Placebo tablet once a day
10932823|NCT00722761|OG000|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
10932824|NCT00722761|OG001|Outcome|Placebo Tablet|Placebo tablet once a day
10932825|NCT00722761|EG000|Reported Event|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
10932826|NCT00722761|EG001|Reported Event|Placebo Tablet|Placebo tablet once a day
10932827|NCT00722800|BG000|Baseline|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
10932828|NCT00722800|BG001|Baseline|Placebo Tablets|Placebo tablet once a day for 6 months
10932829|NCT00722800|BG002|Baseline|Total|Total of all reporting groups
10932830|NCT00722800|FG000|Participant Flow|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
10932831|NCT00722800|FG001|Participant Flow|Placebo Tablets|Placebo tablet once a day for 6 months
10932832|NCT00722800|OG000|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
10932833|NCT00722800|OG001|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
10932834|NCT00722800|EG000|Reported Event|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
10932835|NCT00722800|EG001|Reported Event|Placebo Tablets|Placebo tablet once a day for 6 months
10932836|NCT00722865|BG000|Baseline|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
10932837|NCT00722865|FG000|Participant Flow|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
10932838|NCT00722865|OG000|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
10932839|NCT00722865|EG000|Reported Event|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
10932840|NCT00723008|BG000|Baseline|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
10932841|NCT00723008|BG001|Baseline|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
10932842|NCT00723008|BG002|Baseline|Total|Total of all reporting groups
10932843|NCT00723008|FG000|Participant Flow|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
10932844|NCT00723008|FG001|Participant Flow|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
11175946|NCT02032875|OG000|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
11175947|NCT02032875|OG000|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
10932845|NCT00723008|OG000|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
10932846|NCT00723008|OG001|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
11175948|NCT02032875|OG001|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
11175949|NCT02032875|EG000|Reported Event|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
11175950|NCT02032875|EG001|Reported Event|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
10932847|NCT00723008|OG000|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
10932848|NCT00723008|OG001|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
10932849|NCT00723008|OG002|Outcome|Group B: BEFORE Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
10932850|NCT00723008|OG003|Outcome|Group B: AFTER Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
10932851|NCT00723008|OG002|Outcome|Group B: BEFORE Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
10932852|NCT00723008|OG003|Outcome|Group B: AFTER Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
10932853|NCT00723008|EG000|Reported Event|Group A: Blinded Phase|Subjects receiving double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) for one hour daily.
10932854|NCT00723008|EG001|Reported Event|Group A: Unblinded Phase|Subjects using Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6).
10932855|NCT00723008|EG002|Reported Event|Group B: Blinded Phase|Subjects receiving sham CES treatment for 1 hour daily for 4 weeks.
10932856|NCT00723008|EG003|Reported Event|Group B: Unblinded Phase|Subjects Previously receiving sham device, now using active Alpha Stim device with settings at the patient's preference (1 to 6/6), one hour per day for 5 days per week for 4 weeks.
10932857|NCT00723021|BG000|Baseline|All Participants|Participants receiving any of the 5 treatments (PF-04191834 30 mg, PF-04191834 100 mg, PF-04191834 2000 mg, Zileuton CR 1200 mg and Placebo) in a randomized fashion first
10932858|NCT00723021|FG000|Participant Flow|Treatment Sequence 1|Placebo/Zileuton CR 1200 mg/PF-04191834 30 mg/PF-04191834 2000 mg/PF-04191834 100 mg
10932859|NCT00723021|FG001|Participant Flow|Treatment Sequence 2|PF-04191834 100 mg/PF-04191834 30 mg/PF-04191834 2000 mg/Placebo/Zileuton CR 1200 mg
10932860|NCT00723021|FG002|Participant Flow|Treatment Sequence 3|PF-04191834 2000 mg/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 30 mg/Placebo
10932861|NCT00723021|FG003|Participant Flow|Treatment Sequence 4|PF-04191834 30 mg/Placebo/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 2000 mg
10932862|NCT00723021|FG004|Participant Flow|Treatment Sequence 5|Zileuton CR 1200 mg/PF-04191834 2000 mg/Placebo/PF-04191834 100 mg/PF-04191834 30 mg
10932863|NCT00723021|OG000|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
10932864|NCT00723021|OG001|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
10932865|NCT00723021|OG002|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
10932866|NCT00723021|OG003|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
10932867|NCT00723021|OG004|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
10932868|NCT00723021|OG000|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
10932869|NCT00723021|OG001|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
10932870|NCT00723021|OG002|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
10932871|NCT00723021|OG004|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
10932872|NCT00723021|OG000|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
10932873|NCT00723021|OG001|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
10932874|NCT00723021|OG002|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
10932875|NCT00723021|EG000|Reported Event|Placebo|Participants received single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
10932876|NCT00723021|EG001|Reported Event|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
10932877|NCT00723021|EG002|Reported Event|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
10932878|NCT00723021|EG003|Reported Event|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
10932879|NCT00723021|EG004|Reported Event|Zileuton CR 1200 mg|Paticipants received single oral dose of zileuton CR1200 mg (2 x 600 mg tablets) in any treatment period
10932880|NCT00723073|BG000|Baseline|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
10932881|NCT00723073|BG001|Baseline|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
10932882|NCT00723073|BG002|Baseline|Total|Total of all reporting groups
10932883|NCT00723073|FG000|Participant Flow|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
10932884|NCT00723073|FG001|Participant Flow|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
10932885|NCT00723073|OG000|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
10932886|NCT00723073|OG001|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
10932887|NCT00723073|EG000|Reported Event|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
10932888|NCT00723073|EG001|Reported Event|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
10932889|NCT00723099|BG000|Baseline|Treatment (Chemotherapy, Transplant)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6.~ARM 1(patients at low risk for graft failure) - patients receive 200cGy TBI ARM 2 (patients at high risk for graft failure) - patients receive 300cGy TBI~UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.~IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo single or double umbilical cord blood transplant"
10932890|NCT00723099|FG000|Participant Flow|Arm 1 and 2 Treatment|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6.~Arm 1 (patients with lower risk of graft failure-have received multi-agent chemotherapy in the prior 2 months or history of prior autologous transplant): Patients undergo 200 cGy TBI on day -1.~Arm 2 (patients at higher risk of graft failure-have not received multi agent chemotherapy in the prior 2 months and no history of prior autologous transplant): Patients undergo 300 cGy TBI on day -1~UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.~IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96."
10932891|NCT00723099|OG000|Outcome|Treatment (Chemotherapy, Transplant)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.~UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.~IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant"
10932892|NCT00723099|OG000|Outcome|Treatment (Chemotherapy, Transplant)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.~UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.~IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Total-Body Irradiation: Undergo TBI~Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant"
10932893|NCT00723099|EG000|Reported Event|Treatment (Chemotherapy, Transplant)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6.~Patients with low risk of graft failure receive 200 cGy TBI on day -1.~Patients with high risk of graft failure receive 300 cGy TBI on day -1.~UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.~IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96."
10932894|NCT00723125|BG000|Baseline|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
10932895|NCT00723125|BG001|Baseline|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
10932896|NCT00723125|BG002|Baseline|Total|Total of all reporting groups
10932897|NCT00723125|FG000|Participant Flow|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
10932898|NCT00723125|FG001|Participant Flow|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
10932899|NCT00723125|OG000|Outcome|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
11240661|NCT02481141|OG001|Outcome|5-ALA-SFC Through Week 12 Change From Baseline|Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
11240662|NCT02481141|OG002|Outcome|Placebo Through Week 6 Change From Baseline|Week 6: 1 placebo capsule twice per day
11240663|NCT02481141|OG003|Outcome|Placebo Through Week 12 Change From Baseline|Week 12: 1 placebo capsule twice per day
10932900|NCT00723125|OG001|Outcome|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
10932901|NCT00723125|OG000|Outcome|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14~Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10~Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles~Definitive surgery~Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Abraxane: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks~Carboplatin: Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10~Avastin: Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
10932902|NCT00723125|OG001|Outcome|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7~Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7~Definitive surgery~Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Abraxane: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks~Carboplatin: Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10~Avastin: Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
10932903|NCT00723125|EG000|Reported Event|Cohort 1 Neo-adjuvant|Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10
10932904|NCT00723125|EG001|Reported Event|Cohort 2 Neo-adjuvant|Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)
10932905|NCT00723125|EG002|Reported Event|Cohort 1 DDAC|Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
10932906|NCT00723125|EG003|Reported Event|Cohort 2 DDAC|Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
10932907|NCT00723125|EG004|Reported Event|Cohort 1 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
10932908|NCT00723125|EG005|Reported Event|Cohort 2 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
10932909|NCT00723177|BG000|Baseline|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932910|NCT00723177|BG001|Baseline|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932911|NCT00723177|BG002|Baseline|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932912|NCT00723177|BG003|Baseline|Total|Total of all reporting groups
10932913|NCT00723177|FG000|Participant Flow|Placebo|"This group received placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
10932914|NCT00723177|FG001|Participant Flow|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
10932915|NCT00723177|FG002|Participant Flow|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
10932916|NCT00723177|OG000|Outcome|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932917|NCT00723177|OG001|Outcome|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932918|NCT00723177|OG002|Outcome|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932919|NCT00723177|EG000|Reported Event|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932920|NCT00723177|EG001|Reported Event|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932921|NCT00723177|EG002|Reported Event|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
10932922|NCT00723190|BG000|Baseline|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
10932923|NCT00723190|FG000|Participant Flow|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
10932924|NCT00723190|OG000|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
10932925|NCT00723190|EG000|Reported Event|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
10932926|NCT00723203|BG000|Baseline|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
10932927|NCT00723203|FG000|Participant Flow|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
10932928|NCT00723203|OG000|Outcome|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
10932929|NCT00723203|EG000|Reported Event|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
10932930|NCT00723229|BG000|Baseline|No Medication|
10932931|NCT00723229|BG001|Baseline|Acyclovir 400 mg Twice Daily|
10932932|NCT00723229|BG002|Baseline|Total|Total of all reporting groups
10932933|NCT00723229|FG000|Participant Flow|No Medication First, Then Standard-dose Acyclovir|No medication for 4 weeks, then 1 week washout, followed by acyclovir 400 mg twice daily for 4 weeks
10932934|NCT00723229|FG001|Participant Flow|Acyclovir 400 mg Twice Daily First, Followed by no Medication|Acyclovir 400 mg twice daily for 4 weeks, then 1 week washout, followed by no medication for 4 weeks
10932935|NCT00723229|OG000|Outcome|No Medication|
10932936|NCT00723229|OG001|Outcome|Acyclovir 400 mg Twice Daily|
10932937|NCT00723229|EG000|Reported Event|No Medication|
10932938|NCT00723229|EG001|Reported Event|Acyclovir 400 mg Twice Daily|
10932939|NCT00723255|BG000|Baseline|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
10932940|NCT00723255|FG000|Participant Flow|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
10932941|NCT00723255|OG000|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
10932942|NCT00723255|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10932943|NCT00723255|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10932944|NCT00723255|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10932945|NCT00723255|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10932946|NCT00723255|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10932947|NCT00723255|OG005|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10932948|NCT00723255|OG000|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
10932949|NCT00723255|OG001|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
10932950|NCT00723255|OG000|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
10932951|NCT00723255|OG001|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
10932952|NCT00723255|OG000|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
10932953|NCT00723255|OG001|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
10932954|NCT00723255|EG000|Reported Event|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
10932955|NCT00723294|BG000|Baseline|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
10932956|NCT00723294|FG000|Participant Flow|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
10932957|NCT00723294|OG000|Outcome|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
10932958|NCT00723294|EG000|Reported Event|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
10932959|NCT00723398|BG000|Baseline|Group 1: Control|Control, no intervention
10932960|NCT00723398|BG001|Baseline|Group 2: Raloxifene 60 mg|Raloxifene 60 mg Orally Daily
10932961|NCT00723398|BG002|Baseline|Group 3: Raloxifene 30 mg|Raloxifene 30 mg Orally Daily
10932962|NCT00723398|BG003|Baseline|Group 4: Lovaza 4 gm|Lovaza 4 gm/day Orally with Meals
10932963|NCT00723398|BG004|Baseline|Group 5: Lovaza 4 gm and Raloxifene 30 mg|Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
10932964|NCT00723398|BG005|Baseline|Total|Total of all reporting groups
10932965|NCT00723398|FG000|Participant Flow|Group 1: Control|Control, no intervention
10932966|NCT00723398|FG001|Participant Flow|Group 2: Raloxifene 60 mg|Raloxifene 60 mg Orally Daily
10932967|NCT00723398|FG002|Participant Flow|Group 3: Raloxifene 30 mg|Raloxifene 30 mg Orally Daily
10932968|NCT00723398|FG003|Participant Flow|Group 4: Lovaza 4 gm|Lovaza 4 gm/day Orally with Meals
10932969|NCT00723398|FG004|Participant Flow|Group 5: Lovaza 4 gm and Raloxifene 30 mg|Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
10932970|NCT00723398|OG000|Outcome|Group 1: Control|Control, no intervention
10932971|NCT00723398|OG001|Outcome|Group 2: Raloxifene 60 mg|Raloxifene 60 mg Orally Daily
10932972|NCT00723398|OG002|Outcome|Group 3: Raloxifene 30 mg|Raloxifene 30 mg Orally Daily
10932973|NCT00723398|OG003|Outcome|Group 4: Lovaza 4 gm|Lovaza 4 gm/day Orally with Meals
10932974|NCT00723398|OG004|Outcome|Group 5: Lovaza 4 gm and Raloxifene 30 mg|Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
10932975|NCT00723398|EG000|Reported Event|Group 1: Control|Control, no intervention
10932976|NCT00723398|EG001|Reported Event|Group 2: Raloxifene 60 mg|Raloxifene 60 mg Orally Daily
10932977|NCT00723398|EG002|Reported Event|Group 3: Raloxifene 30 mg|Raloxifene 30 mg Orally Daily
10932978|NCT00723398|EG003|Reported Event|Group 4: Lovaza 4 gm|Lovaza 4 gm/day Orally with Meals
10932979|NCT00723398|EG004|Reported Event|Group 5: Lovaza 4 gm and Raloxifene 30 mg|Lovaza 4 gm/day orally with meals plus Raloxifene 30 mg orally daily
10932980|NCT00723450|BG000|Baseline|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
10932981|NCT00723450|BG001|Baseline|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
10932982|NCT00723450|BG002|Baseline|Total|Total of all reporting groups
10932983|NCT00723450|FG000|Participant Flow|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
10932984|NCT00723450|FG001|Participant Flow|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
10932985|NCT00723450|FG002|Participant Flow|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
10932986|NCT00723450|OG000|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
10932987|NCT00723450|OG001|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
11240664|NCT02481141|OG001|Outcome|5-ALA-SFC Through 4 (75 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
10932988|NCT00723450|OG000|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
10932989|NCT00723450|OG000|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
10932990|NCT00723450|EG000|Reported Event|Open-Label and Open-Label Taper Phases: LTG|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks. Participants discontinuing from the study during the Open-Label Phase entered an open Taper and Follow-up Phase.The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Open-Label Phase.
10932991|NCT00723450|EG001|Reported Event|Randomized and Double-blind Taper Phases: Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks. The participant received Placebo during this Phase.
10932992|NCT00723450|EG002|Reported Event|Randomized and Double-blind Taper Phases: LTG|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Randomized Phase.
10932993|NCT00723489|BG000|Baseline|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
10932994|NCT00723489|BG001|Baseline|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
11240665|NCT02481141|OG002|Outcome|5-ALA-SFC Through 12 (100 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks"
11240666|NCT02481141|EG000|Reported Event|5-ALA-SFC Through Week 2|Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks
10932995|NCT00723489|BG002|Baseline|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
10932996|NCT00723489|BG003|Baseline|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
10932997|NCT00723489|BG004|Baseline|Total|Total of all reporting groups
10932998|NCT00723489|FG000|Participant Flow|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
10932999|NCT00723489|FG001|Participant Flow|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
10933000|NCT00723489|FG002|Participant Flow|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
10933001|NCT00723489|FG003|Participant Flow|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
10933002|NCT00723489|OG000|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
10933003|NCT00723489|OG001|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
10933004|NCT00723489|OG000|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
10933005|NCT00723489|OG001|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
10933006|NCT00723489|EG000|Reported Event|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
10933007|NCT00723489|EG001|Reported Event|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
10933008|NCT00723489|EG002|Reported Event|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
10933009|NCT00723489|EG003|Reported Event|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
10933010|NCT00723528|BG000|Baseline|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
10933011|NCT00723528|BG001|Baseline|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
10933012|NCT00723528|BG002|Baseline|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
11240667|NCT02481141|EG001|Reported Event|5-ALA-SFC Through Week 4|Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks
10933013|NCT00723528|BG003|Baseline|Total|Total of all reporting groups
10933014|NCT00723528|FG000|Participant Flow|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
10933015|NCT00723528|FG001|Participant Flow|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
10933016|NCT00723528|FG002|Participant Flow|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
10933017|NCT00723528|FG003|Participant Flow|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
10963343|NCT00871572|EG001|Reported Event|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
10933018|NCT00723528|FG004|Participant Flow|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
10933019|NCT00723528|FG005|Participant Flow|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
10933020|NCT00723528|FG006|Participant Flow|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
10933021|NCT00723528|OG000|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
10933022|NCT00723528|OG001|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
10933023|NCT00723528|OG002|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
10933024|NCT00723528|OG000|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
10933025|NCT00723528|OG001|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
11175951|NCT02032888|BG000|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
11175952|NCT02032888|BG001|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
10933026|NCT00723528|OG002|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
10933027|NCT00723528|OG003|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
10933028|NCT00723528|EG000|Reported Event|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
10933029|NCT00723528|EG001|Reported Event|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
10933030|NCT00723528|EG002|Reported Event|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
11175953|NCT02032888|BG002|Baseline|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
11175954|NCT02032888|BG003|Baseline|Total|Total of all reporting groups
10933031|NCT00723528|EG003|Reported Event|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
10933032|NCT00723528|EG004|Reported Event|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
10933033|NCT00723528|EG005|Reported Event|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
11175955|NCT02032888|FG000|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily, for 12 weeks of treatment and 24 weeks of follow-up.
10933034|NCT00723528|EG006|Reported Event|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
11175956|NCT02032888|FG001|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
11175957|NCT02032888|FG002|Participant Flow|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
11175958|NCT02032888|OG000|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
11175959|NCT02032888|OG000|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
10933035|NCT00723554|BG000|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
10933036|NCT00723554|FG000|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
10933037|NCT00723554|OG000|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
10933038|NCT00723554|OG000|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
10933039|NCT00723554|OG000|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
10933040|NCT00723554|EG000|Reported Event|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
10933041|NCT00723580|BG000|Baseline|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
10933042|NCT00723580|FG000|Participant Flow|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
10933043|NCT00723580|OG000|Outcome|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
10933044|NCT00723580|EG000|Reported Event|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
10933045|NCT00723606|BG000|Baseline|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
10933046|NCT00723606|BG001|Baseline|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
10933047|NCT00723606|BG002|Baseline|Total|Total of all reporting groups
11175960|NCT02032888|OG000|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
11240668|NCT02481141|EG002|Reported Event|5-ALA-SFC Through Week 12|Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks
10933048|NCT00723606|FG000|Participant Flow|Ziprasidone|An initial intramuscular (IM) injection of ziprasidone 10 or 20 milligram (mg). Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours possible treatment.
10933049|NCT00723606|FG001|Participant Flow|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
10933050|NCT00723606|OG000|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
11175961|NCT02032888|OG000|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
10933051|NCT00723606|OG001|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
10933052|NCT00723606|EG000|Reported Event|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
10933053|NCT00723606|EG001|Reported Event|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
10963344|NCT00871572|EG002|Reported Event|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
10963345|NCT00871572|EG003|Reported Event|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
10963346|NCT00871624|BG000|Baseline|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
10963347|NCT00871624|BG001|Baseline|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
10963348|NCT00871624|BG002|Baseline|Total|Total of all reporting groups
10963349|NCT00871624|FG000|Participant Flow|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
11175962|NCT02032888|OG001|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
11175963|NCT02032888|OG002|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
11175964|NCT02032888|OG000|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
11175965|NCT02032888|OG001|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
11175966|NCT02032888|OG002|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
11175967|NCT02032888|OG000|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
10963350|NCT00871624|FG001|Participant Flow|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
10963351|NCT00871624|OG000|Outcome|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
10963352|NCT00871624|OG001|Outcome|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
11175968|NCT02032888|OG001|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
10963353|NCT00871624|OG000|Outcome|Dexmedetomidine|"Subjects received active dexmedetomidine 0.2 -0.7 mcg/kg/hr~Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4."
10963354|NCT00871624|OG001|Outcome|Placebo|"Subjects received placebo saline solution 0.2-0.7 mcg/kg/hr~Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4."
10963355|NCT00871624|EG000|Reported Event|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
10963356|NCT00871624|EG001|Reported Event|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
10963357|NCT00871689|BG000|Baseline|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
11175969|NCT02032888|OG002|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvi,r 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
11175970|NCT02032888|EG000|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
11175971|NCT02032888|EG001|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
11175972|NCT02032888|EG002|Reported Event|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
11240669|NCT02481141|EG003|Reported Event|Placebo Through Week 2|Beginning Week 0: 1 placebo capsule twice per day for 2 weeks
10933054|NCT00723632|BG000|Baseline|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
10933055|NCT00723632|FG000|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
10933056|NCT00723632|OG000|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
10933057|NCT00723632|EG000|Reported Event|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
10933058|NCT00723645|BG000|Baseline|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
10933059|NCT00723645|FG000|Participant Flow|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
10933060|NCT00723645|OG000|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
10933061|NCT00723645|EG000|Reported Event|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
10933062|NCT00723697|BG000|Baseline|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
10933063|NCT00723697|FG000|Participant Flow|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
10933064|NCT00723697|OG000|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
10933065|NCT00723697|OG000|Outcome|Patients at First Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
10933066|NCT00723697|OG001|Outcome|Patients at 6 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
10933067|NCT00723697|OG002|Outcome|Patients at 12 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
10933068|NCT00723697|EG000|Reported Event|Patients|
10933069|NCT00723710|BG000|Baseline|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
11240670|NCT02481141|EG004|Reported Event|Placebo Through Week 4|Beginning Week 2: 1 placebo capsule twice per day for 2 weeks
10933070|NCT00723710|FG000|Participant Flow|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
10933071|NCT00723710|OG000|Outcome|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
10933072|NCT00723710|EG000|Reported Event|Intron-A|
10933073|NCT00723749|BG000|Baseline|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
10933074|NCT00723749|FG000|Participant Flow|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
10933075|NCT00723749|OG000|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
11240671|NCT02481141|EG005|Reported Event|Placebo Through Week 12|Beginning Week 4: 1 placebo capsule twice per day for 8 weeks
10933076|NCT00723749|EG000|Reported Event|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
10933077|NCT00723788|BG000|Baseline|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
10933078|NCT00723788|FG000|Participant Flow|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
10933079|NCT00723788|OG000|Outcome|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
10933080|NCT00723788|OG001|Outcome|US of the Abdomen|All patients enrolled received an MRI followed in some cases by ultrasund.
10933081|NCT00723788|OG002|Outcome|CT of the Abdomen|All patients enrolled received an MRI followed in some cases by computed tomography.
10933082|NCT00723788|EG000|Reported Event|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
10933083|NCT00723801|BG000|Baseline|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
10933084|NCT00723801|BG001|Baseline|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
10933085|NCT00723801|BG002|Baseline|Total|Total of all reporting groups
10933086|NCT00723801|FG000|Participant Flow|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
11240672|NCT02481206|BG000|Baseline|Wearable Cardioverter Defibrillator|End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.
10933087|NCT00723801|FG001|Participant Flow|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
10933088|NCT00723801|OG000|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
10933089|NCT00723801|OG001|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
10933090|NCT00723801|EG000|Reported Event|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
10933091|NCT00723801|EG001|Reported Event|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
10933092|NCT00723827|BG000|Baseline|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
10933093|NCT00723827|FG000|Participant Flow|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
10933094|NCT00723827|OG000|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
10933095|NCT00723827|EG000|Reported Event|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
10933096|NCT00723840|BG000|Baseline|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
10933097|NCT00723840|FG000|Participant Flow|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
10933098|NCT00723840|OG000|Outcome|Baseline|Costs per participant at baseline in Euros
10933099|NCT00723840|OG001|Outcome|6 Months|Costs per participant at 6 months in Euros
10933100|NCT00723840|OG002|Outcome|12 Months|Costs per participant at 12 months in Euros
10933101|NCT00723840|OG003|Outcome|18 Months|Costs per participant at 18 months in Euros
10933102|NCT00723840|OG000|Outcome|Baseline|QoL scores per participant at baseline
10933103|NCT00723840|OG001|Outcome|6 Months|QoL scores per participant at 6 months
10933104|NCT00723840|OG002|Outcome|12 Months|QoL scores per participant at 12 months
10933105|NCT00723840|OG003|Outcome|18 Months|QoL scores per participant at 18 months
10933106|NCT00723840|EG000|Reported Event|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
10933107|NCT00723892|BG000|Baseline|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
10933108|NCT00723892|BG001|Baseline|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
10933109|NCT00723892|BG002|Baseline|Total|Total of all reporting groups
10933110|NCT00723892|FG000|Participant Flow|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
11240673|NCT02481206|BG001|Baseline|Conventional Treatment|Conventional treatment during hemodialysis initiation will be applied to this arm.
10933111|NCT00723892|FG001|Participant Flow|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
10933112|NCT00723892|OG000|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
10933113|NCT00723892|OG001|Outcome|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
10933114|NCT00723892|OG001|Outcome|PegIntron/Rebetol Alone (no Psychotherapy|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
10933115|NCT00723892|EG000|Reported Event|All Enrolled Participants|
10933116|NCT00723931|BG000|Baseline|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
10933117|NCT00723931|FG000|Participant Flow|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
10933118|NCT00723931|OG000|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
10933119|NCT00723931|EG000|Reported Event|Pegintron/Pegintron Redipen Injection|
10933120|NCT00723957|BG000|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
10933121|NCT00723957|BG001|Baseline|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
10933122|NCT00723957|BG002|Baseline|Total|Total of all reporting groups
10933123|NCT00723957|FG000|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
10933124|NCT00723957|FG001|Participant Flow|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
10933125|NCT00723957|OG000|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
10933126|NCT00723957|OG001|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
10933127|NCT00723957|EG000|Reported Event|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
10933128|NCT00723957|EG001|Reported Event|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
10933129|NCT00724009|BG000|Baseline|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
10933130|NCT00724009|FG000|Participant Flow|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
10933131|NCT00724009|OG000|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
10963358|NCT00871689|FG000|Participant Flow|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
11240674|NCT02481206|BG002|Baseline|Total|Total of all reporting groups
10933132|NCT00724009|EG000|Reported Event|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
10933133|NCT00724061|BG000|Baseline|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
10933134|NCT00724061|FG000|Participant Flow|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
10933135|NCT00724061|OG000|Outcome|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
10933136|NCT00724061|EG000|Reported Event|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
10933137|NCT00724126|BG000|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10933138|NCT00724126|BG001|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10933139|NCT00724126|BG002|Baseline|Total|Total of all reporting groups
10933140|NCT00724126|FG000|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10933141|NCT00724126|FG001|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10933142|NCT00724126|OG000|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10933143|NCT00724126|OG001|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10933144|NCT00724126|EG000|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
11240675|NCT02481206|FG000|Participant Flow|Wearable Cardioverter Defibrillator|End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.
10933145|NCT00724126|EG001|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10933146|NCT00724152|BG000|Baseline|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp randomize.
10933147|NCT00724152|BG001|Baseline|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
10933148|NCT00724152|BG002|Baseline|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp randomize.
10933149|NCT00724152|BG003|Baseline|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
10933150|NCT00724152|BG004|Baseline|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
10933151|NCT00724152|BG005|Baseline|Total|Total of all reporting groups
10963359|NCT00871689|OG000|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
11240676|NCT02481206|FG001|Participant Flow|Conventional Treatment|End Stage Renal Disease (ESRD) patients beginning hemodialysis will get conventional treatment only.
10933152|NCT00724152|FG000|Participant Flow|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
10933153|NCT00724152|FG001|Participant Flow|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.~Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources."
10933154|NCT00724152|FG002|Participant Flow|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
10933155|NCT00724152|OG000|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
10933156|NCT00724152|OG001|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
10933157|NCT00724152|OG002|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
10933158|NCT00724152|OG003|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
10933159|NCT00724152|OG004|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
10933160|NCT00724152|EG000|Reported Event|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
11175973|NCT02032901|BG000|Baseline|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
11175974|NCT02032901|BG001|Baseline|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
11175975|NCT02032901|BG002|Baseline|Total|Total of all reporting groups
11175976|NCT02032901|FG000|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
11240677|NCT02481206|OG000|Outcome|Wearable Cardioverter Defibrillator|End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.
10933161|NCT00724152|EG001|Reported Event|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.~Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment."
10933162|NCT00724152|EG002|Reported Event|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
10933163|NCT00724243|BG000|Baseline|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
10933164|NCT00724243|FG000|Participant Flow|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
10933165|NCT00724243|OG000|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
10933166|NCT00724243|EG000|Reported Event|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
11175977|NCT02032901|FG001|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
11175978|NCT02032901|OG000|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
11175979|NCT02032901|OG001|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
11175980|NCT02032901|OG001|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
11175981|NCT02032901|OG001|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
11175982|NCT02032901|OG000|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
10933167|NCT00724308|BG000|Baseline|Arm 1 - VA Counseling|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
10933168|NCT00724308|BG001|Baseline|Arm 2 - Quitline Counseling|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
10933169|NCT00724308|BG002|Baseline|Total|Total of all reporting groups
10933170|NCT00724308|FG000|Participant Flow|Arm 1 - VA Counselling|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
10933171|NCT00724308|FG001|Participant Flow|Arm 2 - Quitline Counseling|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
10933172|NCT00724308|OG000|Outcome|Arm 1 - VA Counseling|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
10933173|NCT00724308|OG001|Outcome|Arm 2 - Quitline Counseling|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
11175983|NCT02032901|EG000|Reported Event|Daclatasvir + Sofosbuvir|All participants infected with hepatitis C virus (HCV) genotype-3 received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks during the study.
11175984|NCT02033005|BG000|Baseline|Breastfed Infants|>80% of feeds consisting of breast milk at both scanning points
11175985|NCT02033005|BG001|Baseline|Mixed-fed Infants|20%-80% of feeds consisting of breast milk.
11175986|NCT02033005|BG002|Baseline|Formula-fed Infants|>80% of feeds consisting of formula milk at both scanning points
11175987|NCT02033005|BG003|Baseline|Total|Total of all reporting groups
10933174|NCT00724308|EG000|Reported Event|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
10933175|NCT00724308|EG001|Reported Event|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
10933176|NCT00724347|BG000|Baseline|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
10933177|NCT00724347|FG000|Participant Flow|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
10933178|NCT00724347|OG000|Outcome|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
10933179|NCT00724347|EG000|Reported Event|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
10933180|NCT00724373|BG000|Baseline|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
10933181|NCT00724373|FG000|Participant Flow|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
10933182|NCT00724373|OG000|Outcome|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
10933183|NCT00724373|EG000|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
10933184|NCT00724451|BG000|Baseline|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
10933185|NCT00724451|FG000|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy.
10933186|NCT00724451|OG000|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
10933187|NCT00724451|EG000|Reported Event|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
10933188|NCT00724464|BG000|Baseline|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
10933189|NCT00724464|FG000|Participant Flow|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
10933190|NCT00724464|OG000|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
10933191|NCT00724464|OG000|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
10933192|NCT00724464|EG000|Reported Event|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
10933193|NCT00724503|BG000|Baseline|mFOLFOX6 Plus SIRT|A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
10933194|NCT00724503|BG001|Baseline|mFOLFOX6 Alone|Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
10933195|NCT00724503|BG002|Baseline|Total|Total of all reporting groups
10933196|NCT00724503|FG000|Participant Flow|mFOLFOX6 Plus SIRT|A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
10933197|NCT00724503|FG001|Participant Flow|mFOLFOX6 Alone|systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
10933198|NCT00724503|OG000|Outcome|mFOLFOX6 Plus SIRT|A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
10933199|NCT00724503|OG001|Outcome|mFOLFOX6 Alone|Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
11175988|NCT02033005|FG000|Participant Flow|Breastfed Infants|>80% of feeds consisting of breast milk at both scanning points
11175989|NCT02033005|FG001|Participant Flow|Mixed-fed Infants|20%-80% of feeds consisting of breast milk.
10933200|NCT00724503|OG000|Outcome|B: FOLFOX + SIR-Spheres|"A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)~SIR-Spheres yttrium-90 microspheres: SIR-Spheres microspheres implanted once on the 3rd or 4th day of the first week of the first chemotherapy cycle~Systemic chemotherapy (FOLFOX): Oxaliplatin 60 mg/m2,IV infusion, q two weeks for first 3 cycles~Oxaliplatin 85 mg/m2, IV infusion, q two weeks from cycle 4 onwards~Leucovorin 200 mg/m2, IV infusion, q two weeks~5-Fluorouracil 400 mg/m2, IV bolus, q two weeks~5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks"
10933201|NCT00724503|OG001|Outcome|A: FOLFOX Alone|"Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX)~Systemic chemotherapy (FOLFOX): Oxaliplatin 85 mg/m2, IV infusion, q two weeks~Leucovorin 200 mg/m2, IV infusion, q two weeks~5-Fluorouracil 400 mg/m2, IV bolus, q two weeks~5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks"
10933202|NCT00724503|EG000|Reported Event|mFOLFOX6 Plus SIRT|A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
10933203|NCT00724503|EG001|Reported Event|mFOLFOX6 Alone|systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
10933204|NCT00724568|BG000|Baseline|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
10933205|NCT00724568|FG000|Participant Flow|Phase I|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
10933206|NCT00724568|FG001|Participant Flow|Phase II|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
10933207|NCT00724568|OG000|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
10933208|NCT00724568|EG000|Reported Event|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
10933209|NCT00724594|BG000|Baseline|NAC Infant|Infants treated with N-acetylcysteine
10933210|NCT00724594|BG001|Baseline|Control Infant|Infants treated with saline
10933211|NCT00724594|BG002|Baseline|NAC Maternal|Mothers of infants treated with N-acetylcysteine
10933212|NCT00724594|BG003|Baseline|Control Maternal|Mothers of infants treated with saline
10933213|NCT00724594|BG004|Baseline|Total|Total of all reporting groups
10933214|NCT00724594|FG000|Participant Flow|NAC Infant|Infants treated with N-acetylcysteine
10933215|NCT00724594|FG001|Participant Flow|Control Infant|Infants treated with saline
10933216|NCT00724594|FG002|Participant Flow|NAC Maternal|Mothers of infants treated with N-acetylcysteine
10933217|NCT00724594|FG003|Participant Flow|Control Maternal|Mothers of infants treated with saline
10933218|NCT00724594|OG000|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
10933219|NCT00724594|OG001|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
10933220|NCT00724594|OG002|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
10933221|NCT00724594|OG000|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
10933222|NCT00724594|OG000|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to birth
10933223|NCT00724594|OG000|Outcome|NAC Infants|Infants treated with N-acetylcysteine
10933224|NCT00724594|OG001|Outcome|Control Infants|Infants treated with saline
10933225|NCT00724594|OG002|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
10933226|NCT00724594|OG003|Outcome|Control Maternal|Mothers treated with saline prior to delivery
10933227|NCT00724594|OG000|Outcome|NAC Term Infants|Term Infants treated with N-acetylcysteine
10933228|NCT00724594|OG001|Outcome|Control Term Infants|Term Infants treated with saline
10933229|NCT00724594|OG002|Outcome|NAC Preterm Infants|Preterm Infants treated with N-acetylcysteine
10933230|NCT00724594|OG003|Outcome|Control Preterm Infants|Preterm Infants treated with saline
10933231|NCT00724594|OG000|Outcome|NAC Infant|Infants treated with N-acetylcysteine
10933232|NCT00724594|OG001|Outcome|Control Infant|Infants treated with saline
10933233|NCT00724594|OG002|Outcome|NAC Maternal|Mothers of infants treated with N-acetylcysteine
10933234|NCT00724594|OG003|Outcome|Control Maternal|Mothers of infants treated with saline
10933235|NCT00724594|OG000|Outcome|NAC Infants|
10933236|NCT00724594|OG001|Outcome|Control Infants|
10933237|NCT00724594|EG000|Reported Event|NAC Infant|Infants treated with N-acetylcysteine
10933238|NCT00724594|EG001|Reported Event|Control Infant|Infants treated with saline
10933239|NCT00724594|EG002|Reported Event|NAC Maternal|Mothers of infants treated with N-acetylcysteine
10933240|NCT00724594|EG003|Reported Event|Control Maternal|Mothers of infants treated with saline
10933241|NCT00724711|BG000|Baseline|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
10933242|NCT00724711|BG001|Baseline|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
10933243|NCT00724711|BG002|Baseline|Total|Total of all reporting groups
10933244|NCT00724711|FG000|Participant Flow|FTC/TDF (Truvada [TVD]) + PI/r (Ritonavir-boosted PI Regimen)|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
10933245|NCT00724711|FG001|Participant Flow|Abacavir (ABC) /Lamivudine (3TC) + PI/r (Ritonavir-boosted PI)|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
10933246|NCT00724711|OG000|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
10933247|NCT00724711|OG001|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
10933248|NCT00724711|EG000|Reported Event|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
10933249|NCT00724711|EG001|Reported Event|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
10933250|NCT00724750|BG000|Baseline|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
10933251|NCT00724750|BG001|Baseline|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
10933252|NCT00724750|BG002|Baseline|Total|Total of all reporting groups
10933253|NCT00724750|FG000|Participant Flow|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
10933254|NCT00724750|FG001|Participant Flow|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
10933255|NCT00724750|OG000|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
10933256|NCT00724750|OG001|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
10933257|NCT00724750|EG000|Reported Event|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
10933258|NCT00724750|EG001|Reported Event|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
10933259|NCT00724815|BG000|Baseline|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
10933260|NCT00724815|BG001|Baseline|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
10933261|NCT00724815|BG002|Baseline|Total|Total of all reporting groups
10933262|NCT00724815|FG000|Participant Flow|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
10933263|NCT00724815|FG001|Participant Flow|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
10933264|NCT00724815|OG000|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
10933265|NCT00724815|OG001|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
10933266|NCT00724815|EG000|Reported Event|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
10933267|NCT00724815|EG001|Reported Event|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
10933268|NCT00724854|BG000|Baseline|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
10933269|NCT00724854|BG001|Baseline|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
10933270|NCT00724854|BG002|Baseline|Total|Total of all reporting groups
10933271|NCT00724854|FG000|Participant Flow|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
10933272|NCT00724854|FG001|Participant Flow|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
10933273|NCT00724854|OG000|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
10933274|NCT00724854|OG001|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
10933275|NCT00724854|EG000|Reported Event|Mono-Infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
10933276|NCT00724854|EG001|Reported Event|Co-Infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
10933277|NCT00724854|EG002|Reported Event|Not Evaluated|
10933278|NCT00724867|BG000|Baseline|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
10933279|NCT00724867|FG000|Participant Flow|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
10933280|NCT00724867|OG000|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
10933281|NCT00724867|OG000|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
10933282|NCT00724867|OG000|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
10933283|NCT00724867|OG001|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
10933284|NCT00724867|EG000|Reported Event|Belimumab 10 mg/kg IV|Belimumab 10 mg/kg IV every 28 days
10933285|NCT00724893|BG000|Baseline|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
10933286|NCT00724893|BG001|Baseline|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
10933287|NCT00724893|BG002|Baseline|Total|Total of all reporting groups
10933288|NCT00724893|FG000|Participant Flow|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
10933289|NCT00724893|FG001|Participant Flow|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
10933290|NCT00724893|OG000|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
11175990|NCT02033005|FG002|Participant Flow|Formula-fed Infants|>80% of feeds consisting of formula milk at both scanning points
11175991|NCT02033005|OG000|Outcome|Breastfed|>80% of feeds consisting of breastmilk at both scanning points
11175992|NCT02033005|OG001|Outcome|Mixed-fed Infants|20%-80% of feeds consisting of breast milk.
10933291|NCT00724893|OG000|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
10933292|NCT00724893|OG001|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
10933293|NCT00724893|OG000|Outcome|Stage F0|Participants with Fibrosis Stage F0
11175993|NCT02033005|OG002|Outcome|Formula-fed Infants|>80% of feeds consisting of formula milk at both scanning points
11175994|NCT02033005|OG000|Outcome|Breastfed Infants|>80% of feeds consisting of breastmilk at both scanning points
11175995|NCT02033005|EG000|Reported Event|Breastfed Infants|>80% of feeds consisting of breast milk at both scanning points
11175996|NCT02033005|EG001|Reported Event|Mixed-fed Infants|20%-80% of feeds consisting of breast milk.
10933294|NCT00724893|OG001|Outcome|Stage F1|Participants with Fibrosis Stage F1
10933295|NCT00724893|OG002|Outcome|Stage F2|Participants with Fibrosis Stage F2
10933296|NCT00724893|OG003|Outcome|Stage F3|Participants with Fibrosis Stage F4
10933297|NCT00724893|OG004|Outcome|Stage F4|Participants with Fibrosis Stage F4
10933298|NCT00724893|OG005|Outcome|Unknown Stage|Participants with unknown Fibrosis Stage
10933299|NCT00724893|OG000|Outcome|Viral Load High|Participants with viral load xxxx
10933300|NCT00724893|OG001|Outcome|Viral Load Low|Participants with viral load xxxx
10933301|NCT00724893|OG002|Outcome|Viral Load Missing|Participants with viral load missing
11175997|NCT02033005|EG002|Reported Event|Formula-fed Infants|>80% of feeds consisting of formula milk at both scanning points
11175998|NCT02033083|BG000|Baseline|Laminaria|"Patients in this arm will receive laminaria cervical dilators one day before D&E procedure.~Laminaria"
11175999|NCT02033083|BG001|Baseline|Dilapan-S|"Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure.~Dilapan-S"
11176000|NCT02033083|BG002|Baseline|Total|Total of all reporting groups
11176001|NCT02033083|FG000|Participant Flow|Laminaria|"Patients in this arm will receive laminaria cervical dilators one day before D&E procedure.~Laminaria"
10933302|NCT00724893|OG000|Outcome|40 to <50 kg|Participants with weight 40 to <50 kg
10933303|NCT00724893|OG001|Outcome|50 to <64 kg|Participants with weight 50 to <64 kg
10933304|NCT00724893|OG002|Outcome|64 to <75 kg|Participants with weight 64 to <75 kg
10933305|NCT00724893|OG003|Outcome|75 to <85 kg|Participants with weight 75 to <85 kg
10933306|NCT00724893|OG004|Outcome|>85 kg|Participants with weight >85 kg
10933307|NCT00724893|EG000|Reported Event|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
10933308|NCT00724893|EG001|Reported Event|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
10933309|NCT00724932|BG000|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
10933310|NCT00724932|BG001|Baseline|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
10933311|NCT00724932|BG002|Baseline|Total|Total of all reporting groups
10933312|NCT00724932|FG000|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 Post Tetanic Count (PTC)
10933313|NCT00724932|FG001|Participant Flow|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of the second twitch (T2)
10933314|NCT00724932|OG000|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
10933315|NCT00724932|OG001|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
10933316|NCT00724932|OG000|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
10933317|NCT00724932|OG000|Outcome|Neostigmine Only|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
10933318|NCT00724932|EG000|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
10933319|NCT00724932|EG001|Reported Event|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of T2
10933320|NCT00724945|BG000|Baseline|Overall|The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials.
10933321|NCT00724945|FG000|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
10933322|NCT00724945|FG001|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
10933323|NCT00724945|OG000|Outcome|Senofilcon A|multifocal contact lens
10933324|NCT00724945|OG001|Outcome|Balafilcon A|multifocal contact lens
10933325|NCT00724945|EG000|Reported Event|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
10933326|NCT00724945|EG001|Reported Event|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
10933327|NCT00724958|BG000|Baseline|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion.
10933328|NCT00724958|FG000|Participant Flow|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
10933329|NCT00724958|OG000|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
10933330|NCT00724958|EG000|Reported Event|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
10933331|NCT00724971|BG000|Baseline|CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2|"Participants were treated with intravenous rituximab (375 mg/m^2) followed by intravenous CMC-544 (1.8 mg/m^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least stable disease (SD) after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent."
11176002|NCT02033083|FG001|Participant Flow|Dilapan-S|"Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure.~Dilapan-S"
11176003|NCT02033083|OG000|Outcome|Laminaria|"Patients in this arm will receive laminaria cervical dilators one day before D&E procedure.~Laminaria"
11176004|NCT02033083|OG001|Outcome|Dilapan-S|"Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure.~Dilapan-S"
11176005|NCT02033083|EG000|Reported Event|Laminaria|"Patients in this arm will receive laminaria cervical dilators one day before D&E procedure.~Laminaria"
10933332|NCT00724971|FG000|Participant Flow|CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2|"Participants were treated with intravenous rituximab (375 mg/m^2) followed by intravenous CMC-544 (1.8 mg/m^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least stable disease (SD) after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent."
10933333|NCT00724971|OG000|Outcome|CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2|"Participants were treated with intravenous rituximab (375 mg/m^2) followed by intravenous CMC-544 (1.8 mg/m^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least stable disease (SD) after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent."
10933334|NCT00724971|EG000|Reported Event|CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2|"Participants were treated with intravenous rituximab (375 mg/m^2) followed by intravenous CMC-544 (1.8 mg/m^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least stable disease (SD) after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent."
10933335|NCT00724984|BG000|Baseline|Cohort 1(30 mg/m2, 5days/wk)/Phase 1|
10933336|NCT00724984|BG001|Baseline|Cohort 2(45 mg/m2, 5days/wk)/Phase 1|
10933337|NCT00724984|BG002|Baseline|Cohort 3(45 mg/m2, 7days/wk)/Phase 1|
10933338|NCT00724984|BG003|Baseline|Cohort 4(60 mg/m2,7days/wk)/Phase 1|
10933339|NCT00724984|BG004|Baseline|Follicular/Phase II|
10933340|NCT00724984|BG005|Baseline|Mantle Cell Lymphoma/Phase II|
10933341|NCT00724984|BG006|Baseline|Total|Total of all reporting groups
10933342|NCT00724984|FG000|Participant Flow|Cohort 1(30mg/m2,5days/wk)/Phase 1|
10933343|NCT00724984|FG001|Participant Flow|Cohort 2(45mg/m2,5days/wk)/Phase 1|
11176006|NCT02033083|EG001|Reported Event|Dilapan-S|"Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure.~Dilapan-S"
11176007|NCT02033174|BG000|Baseline|All Participants|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
10933344|NCT00724984|FG002|Participant Flow|Cohort 3(45mg/m2,7days/wk)/Phase 1|
11240678|NCT02481206|OG001|Outcome|Conventional Treatment|Conventional treatment during hemodialysis initiation will be applied to this arm.
10933345|NCT00724984|FG003|Participant Flow|Cohort 4(60mg/m2,7days/wk)/Phase 1|
10933346|NCT00724984|FG004|Participant Flow|Follicular/Phase II|
10933347|NCT00724984|FG005|Participant Flow|Mantle Cell Lymphoma/Phase II|
10933348|NCT00724984|OG000|Outcome|Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I|
10933349|NCT00724984|OG001|Outcome|Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I|
10933350|NCT00724984|OG002|Outcome|Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I|
10933351|NCT00724984|OG003|Outcome|Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I|
10933352|NCT00724984|OG000|Outcome|Follicular/Phase II (Efficacy)|
10933353|NCT00724984|OG001|Outcome|Mantle Cell Lymphoma/Phase II (Efficacy)|
10933354|NCT00724984|EG000|Reported Event|Cohort 1(30 mg/m2, 5days/wk)/Phase I|
10933355|NCT00724984|EG001|Reported Event|Cohort 2(45 mg/m2, 5days/wk)/Phase I|
10933356|NCT00724984|EG002|Reported Event|Cohort 3(45 mg/m2, 7days/wk)/Phase I|
10933357|NCT00724984|EG003|Reported Event|Cohort 4(60 mg/m2,7days/wk)/Phase I|
10933358|NCT00724984|EG004|Reported Event|Follicular/Phase II|
10933359|NCT00724984|EG005|Reported Event|Mantle Cell Lymphoma/Phase II|
10933360|NCT00725010|BG000|Baseline|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
10933361|NCT00725010|FG000|Participant Flow|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
10933362|NCT00725010|OG000|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
10933363|NCT00725010|OG001|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
10933364|NCT00725010|EG000|Reported Event|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
10933365|NCT00725010|EG001|Reported Event|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
10933366|NCT00725075|BG000|Baseline|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
10933367|NCT00725075|BG001|Baseline|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
10933368|NCT00725075|BG002|Baseline|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
10933369|NCT00725075|BG003|Baseline|Total|Total of all reporting groups
10933370|NCT00725075|FG000|Participant Flow|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
10933371|NCT00725075|FG001|Participant Flow|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
10933372|NCT00725075|FG002|Participant Flow|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
10933373|NCT00725075|OG000|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
10933374|NCT00725075|OG001|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
11176008|NCT02033174|FG000|Participant Flow|Alcohol First, Then Sugar Water|Participants first received an oral fat-enriched diet (1486 kcal/m2) and a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days. Then, they received equivalent caloric intakes as sugar with water in the control group for 5 days.
10933375|NCT00725075|OG002|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
10933376|NCT00725075|EG000|Reported Event|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
10933377|NCT00725075|EG001|Reported Event|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
10933378|NCT00725075|EG002|Reported Event|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
10933379|NCT00725101|BG000|Baseline|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
10933380|NCT00725101|FG000|Participant Flow|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
10933381|NCT00725101|OG000|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
11176009|NCT02033174|FG001|Participant Flow|Sugar Water First ,Then Alcohol|Participants first received an oral fat-enriched diet (1486 kcal/m2) and sugar with water for 5 days. They then received a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days.
10933382|NCT00725101|EG000|Reported Event|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
10933383|NCT00725153|BG000|Baseline|Overall|All enrolled participants
10933384|NCT00725153|FG000|Participant Flow|PureVision / Acuvue 2|PureVision lenses worn in Period One, Acuvue 2 lenses worn in Period Two. Both products worn for 10 hours each.
10933385|NCT00725153|FG001|Participant Flow|Acuvue 2 / PureVision|Acuvue 2 lenses worn in Period One, PureVision lenses worn in Period Two. Both products worn for 10 hours each.
10933386|NCT00725153|OG000|Outcome|PureVision Contact Lenses|PureVision lenses worn 10 hours
10933387|NCT00725153|OG001|Outcome|Acuvue 2 Contact Lenses|Acuvue 2 lenses worn 10 hours
10933388|NCT00725153|EG000|Reported Event|PureVision Lenses Worn 10 Hours|PureVision lenses worn 10 hours
10933389|NCT00725153|EG001|Reported Event|Acuvue 2 Lenses Worn 10 Hours|Acuvue 2 lenses worn 10 hours
10933390|NCT00725205|BG000|Baseline|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
10933391|NCT00725205|FG000|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Previously untreated Chronic Hepatitis C (CHC) participants treated with a treatment regimen of 1.5 micgrograms (mcg)/killogram (kg) Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
10933392|NCT00725205|OG000|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
10933393|NCT00725205|EG000|Reported Event|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
10933394|NCT00725270|BG000|Baseline|Placebo|Patients will be randomized to placebo
10933395|NCT00725270|BG001|Baseline|Mifepristone|Patients will be randomized to mifepristone
10933396|NCT00725270|BG002|Baseline|Total|Total of all reporting groups
10933397|NCT00725270|FG000|Participant Flow|Placebo|Patients will be randomized to placebo
10933398|NCT00725270|FG001|Participant Flow|Mifepristone|Patients will be randomized to mifepristone
10933399|NCT00725270|OG000|Outcome|Placebo|Patients will be randomized to placebo
10933400|NCT00725270|OG001|Outcome|Mifepristone|Patients will be randomized to mifepristone
10933401|NCT00725270|EG000|Reported Event|Placebo|Patients will be randomized to placebo
10933402|NCT00725270|EG001|Reported Event|Mifepristone|Patients will be randomized to mifepristone
10933403|NCT00725283|BG000|Baseline|GSK2130579A Group|Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
10933404|NCT00725283|FG000|Participant Flow|GSK2130579A Group|Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
10933405|NCT00725283|OG000|Outcome|GSK2130579A Group|Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
10933406|NCT00725283|EG000|Reported Event|GSK2130579A Group|Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
10933407|NCT00725296|BG000|Baseline|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
10933408|NCT00725296|FG000|Participant Flow|Infliximab|Participants with active and progressive psoriatic arthritis (PsA) who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
10933409|NCT00725296|OG000|Outcome|Infliximab|Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
10933410|NCT00725296|OG000|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
10933411|NCT00725296|EG000|Reported Event|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
10933412|NCT00725322|BG000|Baseline|Placebo Then Botox|"Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma~Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue"
10933413|NCT00725322|BG001|Baseline|Botox Then Placebo|"Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue~Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma"
10933414|NCT00725322|BG002|Baseline|Total|Total of all reporting groups
10933415|NCT00725322|FG000|Participant Flow|Placebo Then Botox|"Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma~Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin."
10933416|NCT00725322|FG001|Participant Flow|Botox Then Placebo|"Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue~Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin."
10933417|NCT00725322|OG000|Outcome|Placebo|Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma
10933418|NCT00725322|OG001|Outcome|Botox|Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
10933419|NCT00725322|EG000|Reported Event|Placebo Then Botox|"Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma~Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin."
10933420|NCT00725322|EG001|Reported Event|Botox Then Placebo|"Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma~Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin."
10933421|NCT00725361|BG000|Baseline|Active|"Ambrisentan~Ambrisentan"
10933422|NCT00725361|FG000|Participant Flow|Ambrisentan|5 mg orally daily X 4 weeks then 10 mg daily as tolerated
10933423|NCT00725361|OG000|Outcome|Active|"Ambrisentan~Ambrisentan"
10933424|NCT00725361|EG000|Reported Event|Active|"Ambrisentan~Ambrisentan"
10933425|NCT00725452|BG000|Baseline|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
10933426|NCT00725452|FG000|Participant Flow|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
10933427|NCT00725452|OG000|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
10933428|NCT00725452|EG000|Reported Event|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
10933429|NCT00725504|BG000|Baseline|Lidocaine Infusion|"Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.~Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml"
10933430|NCT00725504|FG000|Participant Flow|Lidocaine Infusion|"Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.~Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml"
10933431|NCT00725504|OG000|Outcome|Baseline|Each participant was tested at the zero infusion rate.
10933432|NCT00725504|OG001|Outcome|Placebo|Each participant received a placebo-saline infusion.
10933433|NCT00725504|OG002|Outcome|Lidocaine 3 µg/ml|Each participant received an intravenous infusion of 3 µg/ml of lidocaine.
10933434|NCT00725504|OG003|Outcome|Lidocaine 5 µg/ml|Each participant received an intravenous infusion of 5 µg/ml of lidocaine.
10933435|NCT00725504|EG000|Reported Event|Lidocaine Infusion|Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.
10933436|NCT00725530|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
10933437|NCT00725530|FG000|Participant Flow|Balafilcon A / Etafilcon A|Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
10933438|NCT00725530|FG001|Participant Flow|Etafilcon A / Balafilcon A|Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
10933439|NCT00725530|OG000|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
10933440|NCT00725530|OG001|Outcome|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
10933441|NCT00725530|EG000|Reported Event|Balafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
10933442|NCT00725530|EG001|Reported Event|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
10933443|NCT00725543|BG000|Baseline|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
10933444|NCT00725543|FG000|Participant Flow|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
10933445|NCT00725543|OG000|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
10933446|NCT00725543|EG000|Reported Event|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
10933447|NCT00725608|BG000|Baseline|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
10933448|NCT00725608|FG000|Participant Flow|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
10933449|NCT00725608|OG000|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
10933450|NCT00725608|EG000|Reported Event|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
10933451|NCT00725621|BG000|Baseline|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
11176010|NCT02033174|OG000|Outcome|Alcoholic Beverages (Red Wine Intake)|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine
10933452|NCT00725621|FG000|Participant Flow|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
10933453|NCT00725621|OG000|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
11176011|NCT02033174|OG001|Outcome|Oral Fat Diet|The fat-enriched diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
11176012|NCT02033174|EG000|Reported Event|Alcoholic Beverages|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
11176013|NCT02033174|EG001|Reported Event|Oral Fat Diet|Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
11176014|NCT02033200|BG000|Baseline|Active|Stendra 200 mg
10933454|NCT00725621|OG001|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
10933455|NCT00725621|OG002|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
10933456|NCT00725621|OG000|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
10933457|NCT00725621|OG001|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
10933458|NCT00725621|EG000|Reported Event|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
10933459|NCT00725712|BG000|Baseline|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
10933460|NCT00725712|BG001|Baseline|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
10933461|NCT00725712|BG002|Baseline|Total|Total of all reporting groups
10933462|NCT00725712|FG000|Participant Flow|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 milligram (mg) per dosing day orally, on 5 days on and 9 days off cycle every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose
10933463|NCT00725712|FG001|Participant Flow|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
10933464|NCT00725712|OG000|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
11176015|NCT02033200|BG001|Baseline|Placebo|placebo
10933465|NCT00725712|OG001|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
10933466|NCT00725712|OG000|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200 mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
10933467|NCT00725712|OG001|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 and 9 dosing arm.
11176016|NCT02033200|BG002|Baseline|Total|Total of all reporting groups
11176017|NCT02033200|FG000|Participant Flow|Active|Stendra 200 mg
10933468|NCT00725712|OG000|Outcome|GSK1363089, Intermittent 5 & 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
11176018|NCT02033200|FG001|Participant Flow|Placebo|placebo
11176019|NCT02033200|OG000|Outcome|Active|Stendra 200 mg
11176020|NCT02033200|OG001|Outcome|Placebo|placebo
11176021|NCT02033200|EG000|Reported Event|Active|Stendra 200 mg
11176022|NCT02033200|EG001|Reported Event|Placebo|placebo
10933469|NCT00725712|OG001|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm
10933470|NCT00725712|EG000|Reported Event|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally ( viz. foretinib solid capsules of 20, 100 and 200 mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
10933471|NCT00725712|EG001|Reported Event|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 and 9 dosing arm.
10933472|NCT00725725|BG000|Baseline|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
10933473|NCT00725725|BG001|Baseline|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
10933474|NCT00725725|BG002|Baseline|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
10933475|NCT00725725|BG003|Baseline|Total|Total of all reporting groups
10933476|NCT00725725|FG000|Participant Flow|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
10933477|NCT00725725|FG001|Participant Flow|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
10933478|NCT00725725|FG002|Participant Flow|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
11176023|NCT02033213|BG000|Baseline|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
10933479|NCT00725725|OG000|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
10933480|NCT00725725|OG001|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
10933481|NCT00725725|OG002|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
10933482|NCT00725725|EG000|Reported Event|Org 25935 4 mg|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
10933483|NCT00725725|EG001|Reported Event|Org 25935 12 mg|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
10933484|NCT00725725|EG002|Reported Event|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
10933485|NCT00725751|BG000|Baseline|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
10933486|NCT00725751|BG001|Baseline|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
10933487|NCT00725751|BG002|Baseline|Total|Total of all reporting groups
10933488|NCT00725751|FG000|Participant Flow|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
10933489|NCT00725751|FG001|Participant Flow|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
10933490|NCT00725751|OG000|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
10933491|NCT00725751|OG001|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
10933492|NCT00725751|OG000|Outcome|All Participants|"Participants who received at least one dose of antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)~Participants who received at least one dose of antiviral treatment and did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)"
10933493|NCT00725751|EG000|Reported Event|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
10933494|NCT00725751|EG001|Reported Event|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
10933495|NCT00725764|BG000|Baseline|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
10933496|NCT00725764|FG000|Participant Flow|Foretinib 240 mg|In each treatment period, participants received foretinib 240 milligram (mg) capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of progressive disease (PD) and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
10933497|NCT00725764|OG000|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
10933498|NCT00725764|OG000|Outcome|Foretinib 240 mg|This study consisted of a pre-treatment Period (screening and baseline evaluations), 8 week study treatment period, an optional treatment extension period, and a post-treatment period (including an end-of-treatment visit and an extended follow-up period). In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
10933499|NCT00725764|EG000|Reported Event|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
10933500|NCT00725842|BG000|Baseline|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
10933501|NCT00725842|FG000|Participant Flow|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
10933502|NCT00725842|OG000|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
10933503|NCT00725842|EG000|Reported Event|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
10933504|NCT00725920|BG000|Baseline|Topiramate|patients receiving the active drug: topiramate
10933505|NCT00725920|BG001|Baseline|Control Group|patients received pills content placebo, that were identical to the pills content active drug
10933506|NCT00725920|BG002|Baseline|Total|Total of all reporting groups
10933507|NCT00725920|FG000|Participant Flow|Topiramate|patients receiving the active drug: topiramate. Patients will receive topiramate pills, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
10933508|NCT00725920|FG001|Participant Flow|Control Group|patients receiving placebo pills, that were identical to the pills content active drug, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
10933509|NCT00725920|OG000|Outcome|Topiramate|patients receiving the active drug: topiramate
10933510|NCT00725920|OG001|Outcome|Control Group|patients received pills content placebo, that were identical to the pills content active drug
10933511|NCT00725920|EG000|Reported Event|Topiramate|patients receiving the active drug: topiramate
10933512|NCT00725920|EG001|Reported Event|Control Group|patients received pills content placebo, that were identical to the pills content active drug
10933513|NCT00725959|BG000|Baseline|Arm 1|Group exposed to dynamic content on Facebook re: HIV Prevention
10933514|NCT00725959|BG001|Baseline|Arm 2|Attention Control exposed to a current events Facebook page
10933515|NCT00725959|BG002|Baseline|Total|Total of all reporting groups
10933516|NCT00725959|FG000|Participant Flow|Intervention Arm|Group exposed to dynamic content on Facebook re: HIV Prevention
10933517|NCT00725959|FG001|Participant Flow|Control Arm|Attention Control exposed to a current events Facebook page
10933518|NCT00725959|OG000|Outcome|Arm 1|Group exposed to dynamic content on Facebook re: HIV Prevention
10933519|NCT00725959|OG001|Outcome|Arm 2|
10933520|NCT00725959|EG000|Reported Event|Arm 1|Group exposed to dynamic content on Facebook re: HIV Prevention
10933521|NCT00725959|EG001|Reported Event|Arm 2|Attention Control exposed to a current events Facebook page
11240679|NCT02481206|OG000|Outcome|Wearable Cardioverter Defibrillator Used|Time during which a wearable defibrillator was actually worn, whether in the intention to treat wearable defibrillator arm or the control arm (crossovers). All other time will be analyzed as part of the control group.
10933522|NCT00726232|BG000|Baseline|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933523|NCT00726232|BG001|Baseline|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933524|NCT00726232|BG002|Baseline|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933525|NCT00726232|BG003|Baseline|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933526|NCT00726232|BG004|Baseline|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933527|NCT00726232|BG005|Baseline|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933528|NCT00726232|BG006|Baseline|Total|Total of all reporting groups
10933529|NCT00726232|FG000|Participant Flow|Polycythemia Vera (PV): Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933530|NCT00726232|FG001|Participant Flow|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933531|NCT00726232|FG002|Participant Flow|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933532|NCT00726232|FG003|Participant Flow|Essential Thrombocythemia (ET): Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933533|NCT00726232|FG004|Participant Flow|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933534|NCT00726232|FG005|Participant Flow|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933535|NCT00726232|FG006|Participant Flow|PV: Ruxolitinib All Doses Combined- Expansion Phase|After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 10 mg BID for subjects with PV. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
10933536|NCT00726232|FG007|Participant Flow|ET: Ruxolitinib All Doses Combined-expansion Phase|After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 25 mg BID for subjects with ET. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
10933537|NCT00726232|OG000|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933538|NCT00726232|OG001|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933539|NCT00726232|OG002|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933540|NCT00726232|OG000|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933541|NCT00726232|OG001|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933542|NCT00726232|OG002|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933543|NCT00726232|OG003|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933544|NCT00726232|OG004|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933545|NCT00726232|OG005|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933546|NCT00726232|EG000|Reported Event|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933547|NCT00726232|EG001|Reported Event|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933548|NCT00726232|EG002|Reported Event|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
11240680|NCT02481206|OG001|Outcome|Wearable Cardioverter Defibrillator Not Used|Time during which a wearable defibrillator was not worn, whether in the intention to treat wearable defibrillator arm (crossovers) or the control arm.
10933549|NCT00726232|EG003|Reported Event|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933550|NCT00726232|EG004|Reported Event|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933551|NCT00726232|EG005|Reported Event|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
10933552|NCT00726232|EG006|Reported Event|PV: Ruxolitinib All Doses Combined- Expansion Phase|After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 10 mg BID for subjects with PV. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
10933553|NCT00726232|EG007|Reported Event|ET: Ruxolitinib All Doses Combined-expansion Phase|After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 25 mg BID for subjects with ET. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety.
10933554|NCT00726323|BG000|Baseline|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
10933555|NCT00726323|BG001|Baseline|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
10933556|NCT00726323|BG002|Baseline|Total|Total of all reporting groups
10933557|NCT00726323|FG000|Participant Flow|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 milligrams (mg) on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
10933558|NCT00726323|FG001|Participant Flow|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
10933559|NCT00726323|OG000|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
10933560|NCT00726323|OG001|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
10933561|NCT00726323|EG000|Reported Event|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up every 8 weeks for tumor assessment, while the participant remained in the treatment extension period.
11176024|NCT02033213|BG001|Baseline|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
11176025|NCT02033213|BG002|Baseline|Total|Total of all reporting groups
10933562|NCT00726323|EG001|Reported Event|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up every 8 weeks for tumor assessment, while the participant remained in the treatment extension period.
11176026|NCT02033213|FG000|Participant Flow|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
11240681|NCT02481206|EG000|Reported Event|Wearable Cardioverter Defibrillator|End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.
10933563|NCT00726375|BG000|Baseline|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
10933564|NCT00726375|FG000|Participant Flow|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
10933565|NCT00726375|OG000|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
10933566|NCT00726375|EG000|Reported Event|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
10933567|NCT00726388|BG000|Baseline|DIC075V|Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
10933568|NCT00726388|FG000|Participant Flow|DIC075V|Participants weighing greater than or equal to (>=) 95 kg received DIC075V 50 milligram (mg) IV bolus once every 6 hours. Participants with more than 1 non-steroidal anti-inflammatory drug (NSAIDS) related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
10933569|NCT00726388|OG000|Outcome|DIC075V|Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
10933570|NCT00726388|EG000|Reported Event|DIC075V|Participants weighing >=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing <95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V.
10933571|NCT00726414|BG000|Baseline|Quinine Sulfate Under Fed and Fasted Conditions|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast or 30 minutes following a standardized, high fat breakfast.
10933572|NCT00726414|FG000|Participant Flow|Quinine Sulfate Under Fasted Then Fed Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast.
10933573|NCT00726414|FG001|Participant Flow|Quinine Sulfate Under Fed Then Fasted Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
10933574|NCT00726414|OG000|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
11176027|NCT02033213|FG001|Participant Flow|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
10933575|NCT00726414|OG001|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
10933576|NCT00726414|EG000|Reported Event|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
10933577|NCT00726414|EG001|Reported Event|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
10933578|NCT00726453|BG000|Baseline|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
10933579|NCT00726453|BG001|Baseline|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed. This sub-study completed the primary endpoint in March 2012 results not yet available.
10933580|NCT00726453|BG002|Baseline|Total|Total of all reporting groups
10933581|NCT00726453|FG000|Participant Flow|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
10933582|NCT00726453|FG001|Participant Flow|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
10933583|NCT00726453|OG000|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
10933584|NCT00726453|EG000|Reported Event|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study and are collectively referred to as the Primary Enrollment Group (PEG)."
10933585|NCT00726453|EG001|Reported Event|38 mm Length Sub-Study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
10933586|NCT00726557|BG000|Baseline|PegIntron + Rebetol|Baseline measures only available for the 118 participants who completed.
10933587|NCT00726557|FG000|Participant Flow|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
10933588|NCT00726557|OG000|Outcome|Participants With Negative HCV-RNA at End of Treatment|End of treatment is 24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4
10933589|NCT00726557|OG000|Outcome|Participants Who Tolerated Treatment|Those who completed treatment.
10933590|NCT00726557|EG000|Reported Event|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
10933591|NCT00726609|BG000|Baseline|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
10933592|NCT00726609|FG000|Participant Flow|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
10933593|NCT00726609|OG000|Outcome|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
10933594|NCT00726609|EG000|Reported Event|Posaconazole (Assigned by Physician in Normal Practice)|
10933595|NCT00726622|BG000|Baseline|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
10933596|NCT00726622|BG001|Baseline|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
10933597|NCT00726622|BG002|Baseline|Total|Total of all reporting groups
11240682|NCT02481206|EG001|Reported Event|Conventional Treatment|Conventional treatment during hemodialysis initiation will be applied to this arm.
11240683|NCT02481219|BG000|Baseline|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
10933598|NCT00726622|FG000|Participant Flow|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
10933599|NCT00726622|FG001|Participant Flow|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
10933600|NCT00726622|OG000|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
10933601|NCT00726622|OG001|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
10933602|NCT00726622|EG000|Reported Event|Arm 1: Open Laparotomy and Rectal Resection|Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection.
10933603|NCT00726622|EG001|Reported Event|Arm 2: Laparoscopic-assisted Rectal Resection|Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.
10933604|NCT00726661|BG000|Baseline|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
10933605|NCT00726661|BG001|Baseline|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
11176028|NCT02033213|OG000|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
10933606|NCT00726661|BG002|Baseline|Total|Total of all reporting groups
10933607|NCT00726661|FG000|Participant Flow|Chemotherapy Cohort|Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
10933608|NCT00726661|FG001|Participant Flow|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
10933609|NCT00726661|OG000|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
10933610|NCT00726661|OG001|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
10933611|NCT00726661|OG000|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
10933612|NCT00726661|EG000|Reported Event|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
10933613|NCT00726661|EG001|Reported Event|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
10933614|NCT00726713|BG000|Baseline|Metanx|Metanx one tablet twice a day
10933615|NCT00726713|BG001|Baseline|Placebo|Placebo one tablet twice a day
10933616|NCT00726713|BG002|Baseline|Total|Total of all reporting groups
10933617|NCT00726713|FG000|Participant Flow|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
10933618|NCT00726713|FG001|Participant Flow|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
10933619|NCT00726713|OG000|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
10933620|NCT00726713|OG001|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
10933621|NCT00726713|OG001|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
10933622|NCT00726713|EG000|Reported Event|Metanx|Metanx one tablet twice a day
10933623|NCT00726713|EG001|Reported Event|Placebo|Placebo one tablet twice a day
10933624|NCT00726739|BG000|Baseline|Arm I and III Crossover Group - LMI + Aldesleukin|"Includes 6 patients who progressed and crossed over from Arm II."
10933625|NCT00726739|BG001|Baseline|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
10933626|NCT00726739|BG002|Baseline|Total|Total of all reporting groups
10933627|NCT00726739|FG000|Participant Flow|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
10933628|NCT00726739|FG001|Participant Flow|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
10933629|NCT00726739|OG000|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
10933630|NCT00726739|OG001|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
10933631|NCT00726739|OG000|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II. Both KLH and DTH are tests assessing the ability to respond to immune therapy. These are independent tests and there is no bearing of KLH response on DTH response."
10933632|NCT00726739|EG000|Reported Event|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
10933633|NCT00726739|EG001|Reported Event|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on arm I.
10933634|NCT00726752|BG000|Baseline|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
10933635|NCT00726752|FG000|Participant Flow|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
10933636|NCT00726752|OG000|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
10933637|NCT00726752|EG000|Reported Event|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
10933638|NCT00726882|BG000|Baseline|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333.~Participants received no treatment in this follow-up study."
10933639|NCT00726882|FG000|Participant Flow|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333.~Participants received no treatment in this follow-up study."
10933640|NCT00726882|OG000|Outcome|Participants From Study M10-380|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00851890/M10-380) involving ABT-333.~Participants received no treatment in this follow-up study."
10933641|NCT00726882|OG001|Outcome|Participants From Study M10-351|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00696904/M10-351) involving ABT-333.~Participants received no treatment in this follow-up study."
10933642|NCT00726882|OG000|Outcome|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333.~Participants received no treatment in this follow-up study."
10933643|NCT00726882|EG000|Reported Event|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333.~Participants received no treatment in this follow-up study."
10933644|NCT00726895|BG000|Baseline|Entire Study Population|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received either one Quinine Sulfate 324 mg capsule or two Quinine Sulfate 324 mg capsules following an overnight fast of at least 10 hours.
10933645|NCT00726895|FG000|Participant Flow|Quinine Sulfate Capsules 1 x 324 mg Dose Then 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933646|NCT00726895|FG001|Participant Flow|Quinine Sulfate Capsules 2 x 324 mg Dose Then 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933647|NCT00726895|OG000|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
10933648|NCT00726895|OG001|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
10933649|NCT00726895|OG002|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
10933650|NCT00726895|EG000|Reported Event|Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933651|NCT00726895|EG001|Reported Event|Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933652|NCT00726986|BG000|Baseline|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
10933653|NCT00726986|FG000|Participant Flow|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
11176029|NCT02033213|OG001|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
11176030|NCT02033213|OG000|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
11240684|NCT02481219|BG001|Baseline|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
11240685|NCT02481219|BG002|Baseline|Total|Total of all reporting groups
10933654|NCT00726986|OG000|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
10933655|NCT00726986|EG000|Reported Event|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
10933656|NCT00726999|BG000|Baseline|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
10933657|NCT00726999|BG001|Baseline|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
10933658|NCT00726999|BG002|Baseline|Total|Total of all reporting groups
10933659|NCT00726999|FG000|Participant Flow|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
10933660|NCT00726999|FG001|Participant Flow|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
10933661|NCT00726999|OG000|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
10933662|NCT00726999|OG001|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
10933663|NCT00726999|OG000|Outcome|Gabapentin Group|"Gabapentin~Gabapentin: oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge~Morphine: Administered as needed"
10933664|NCT00726999|OG001|Outcome|Placebo Group|"Placebo Comparator -- pill matched in appearance to gabapentin~Placebo~Morphine: Administered as needed"
10933665|NCT00726999|EG000|Reported Event|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
10933666|NCT00726999|EG001|Reported Event|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
11176031|NCT02033213|OG001|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
11176032|NCT02033213|EG000|Reported Event|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
11176033|NCT02033213|EG001|Reported Event|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
11176034|NCT02033317|BG000|Baseline|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
11176035|NCT02033317|FG000|Participant Flow|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
11176036|NCT02033317|OG000|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
10933667|NCT00727025|BG000|Baseline|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
11176037|NCT02033317|EG000|Reported Event|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally.
10933668|NCT00727025|FG000|Participant Flow|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
11176038|NCT02033369|BG000|Baseline|MDD Patients|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day"
11176039|NCT02033369|BG001|Baseline|Healthy Control Patients|Healthy control patients did not receive study medication and only have baseline measures.
11176040|NCT02033369|BG002|Baseline|Total|Total of all reporting groups
11176041|NCT02033369|FG000|Participant Flow|MDD Patients|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day"
11176042|NCT02033369|FG001|Participant Flow|Healthy Controls|Individuals without depression
11176043|NCT02033369|OG000|Outcome|Pramipexole|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day"
11176044|NCT02033369|EG000|Reported Event|MDD Patients|Only patients with MDD received treatment. There was only one arm.
11176045|NCT02033382|BG000|Baseline|Healthy Controls|Age and gender matched healthy controls
11176046|NCT02033382|BG001|Baseline|Patients|Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
11176047|NCT02033382|BG002|Baseline|Total|Total of all reporting groups
11176048|NCT02033382|FG000|Participant Flow|Healthy Controls|Age and gender matched healthy controls
11176049|NCT02033382|FG001|Participant Flow|Patients|Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
11176050|NCT02033382|OG000|Outcome|Healthy Controls|Age and gender matched healthy controls
11176051|NCT02033382|OG001|Outcome|Patients|Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
11176052|NCT02033382|OG000|Outcome|Baseline|Biomarkers at baseline prior to risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects.
11176053|NCT02033382|OG001|Outcome|Week 8|Biomarkers at week 8 of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects.
11176054|NCT02033382|OG000|Outcome|Baseline|salivary cortisol at baseline prior to risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects.
11176055|NCT02033382|OG001|Outcome|Week 8|salivary cortisol at week 8 of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects.
11176056|NCT02033382|EG000|Reported Event|Healthy Controls|Age and gender matched healthy controls
11176057|NCT02033382|EG001|Reported Event|Patients|Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
11176058|NCT02033499|BG000|Baseline|No Testing|No SMBG testing
11176059|NCT02033499|BG001|Baseline|SMBG Standard Messaging|Daily SMBG with standard messaging
11176060|NCT02033499|BG002|Baseline|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
11176061|NCT02033499|BG003|Baseline|Total|Total of all reporting groups
11176062|NCT02033499|FG000|Participant Flow|No Testing|No SMBG testing
11176063|NCT02033499|FG001|Participant Flow|SMBG Standard Messaging|Daily SMBG with standard messaging
10933669|NCT00727025|OG000|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
11176064|NCT02033499|FG002|Participant Flow|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
11176065|NCT02033499|OG000|Outcome|No Testing|No Self-Monitoring of Blood Glucose (SMBG) testing
11176066|NCT02033499|OG001|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
10933670|NCT00727025|OG001|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
10933671|NCT00727025|OG000|Outcome|Steri-strip Closure|
10933672|NCT00727025|OG001|Outcome|Suture Closure|
10933673|NCT00727025|EG000|Reported Event|Wounds Closed With Device|segment of wounds closed with steri-strip device
10933674|NCT00727025|EG001|Reported Event|Wounds Closed With Suture|wound segments closed with traditional suture
10933675|NCT00727064|BG000|Baseline|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
10933676|NCT00727064|BG001|Baseline|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
10933677|NCT00727064|BG002|Baseline|Total|Total of all reporting groups
10933678|NCT00727064|FG000|Participant Flow|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
10933679|NCT00727064|FG001|Participant Flow|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
10933680|NCT00727064|OG000|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
11176067|NCT02033499|OG002|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
11176068|NCT02033499|OG000|Outcome|No Testing|No SMBG testing
11176069|NCT02033499|EG000|Reported Event|No Testing|No SMBG testing
11176070|NCT02033499|EG001|Reported Event|SMBG Standard Messaging|Daily SMBG with standard messaging
11176071|NCT02033499|EG002|Reported Event|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
11176072|NCT02033694|BG000|Baseline|Participants With 2 Year Follow up|Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
11176073|NCT02033694|FG000|Participant Flow|Participants With 2 Year Follow up|Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
10933681|NCT00727064|OG001|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
10933682|NCT00727064|EG000|Reported Event|Desvenlafaxine Succinate Sustained-Release (DVS SR)|SAE or AE reported on DVS SR regardless of which arm or period of trial.
10933683|NCT00727064|EG001|Reported Event|Venlafaxine Extended Release (VEN ER)|SAE or AE reported on VEN ER regardless of which arm or period of trial.
10933684|NCT00727194|BG000|Baseline|Overall Study|"Eculizumab:~Eculizumab [600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)].~Period 1: patients received eculizumab for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received placebo for 16 weeks.~Placebo:~Matching placebo [IV weekly (4 doses) followed by IV every other week (7 doses)] Period 1: patients received placebo for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received eculizumab for 16 weeks."
11176074|NCT02033694|OG000|Outcome|Participants With 2 Year Follow up|Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
11176075|NCT02033694|OG000|Outcome|Participants With 2 Year Follow up|Participants with NIRS-IVUS imaging at baseline and follow up for 2 years
11176076|NCT02033694|EG000|Reported Event|All Patients With Baseline NIRS-IVUS Imaging|Participants with NIRS-IVUS imaging at baseline
10933685|NCT00727194|FG000|Participant Flow|Eculizumab to Placebo Sequence|"Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)~Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses)~Period 1: patients received eculizumab for 16 weeks.~Wash-out period for 5 weeks.~Period 2 (cross-over treatment period): patients received placebo for 16 weeks."
10933686|NCT00727194|FG001|Participant Flow|Placebo to Eculizumab Sequence|"Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses).~Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses).~Period 1: patients received placebo for 16 weeks.~Wash-out period for 5 weeks.~Period 2 (cross-over treatment period): patients received eculizumab for 16 weeks."
10933687|NCT00727194|FG002|Participant Flow|Not Randomized/Screen Failures|Not randomized; not treatment cohort
10933688|NCT00727194|OG000|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
10933689|NCT00727194|OG001|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
10933690|NCT00727194|OG002|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
10933691|NCT00727194|OG003|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
10933692|NCT00727194|OG002|Outcome|Eculizumab Period 2|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
11176077|NCT02033759|BG000|Baseline|Traditional Circumferential Measurements|"Traditional screening with volumetric analysis Patient Anxiety Questionnaire~Anxiety Questionnaire: 21 item questionnaire~Traditional Circumferential Measurements~Traditional screening involved circumferential measurements using a tape measure, every 4cm from the wrist to the axilla, after which a standardized computer algorithm calculated limb volume in milliliters. Significant changes were defined as >3% volume increase when compared with the preoperative baseline limb measurements, without other clear explanation (commonly accepted unilateral volume change according to the International Society of Lymphology)."
11240686|NCT02481219|FG000|Participant Flow|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
10933693|NCT00727194|OG003|Outcome|Placebo Period 2|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
10933694|NCT00727194|OG000|Outcome|Eculizumab Period 1|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
10933695|NCT00727194|OG002|Outcome|Eculizumab Both Periods|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
10933696|NCT00727194|OG000|Outcome|Eculizumab|All patients who received study treatment(s)
10933697|NCT00727194|OG001|Outcome|Placebo|All patients who received study treatment(s)
10933698|NCT00727194|EG000|Reported Event|Placebo|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses~Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
10933699|NCT00727194|EG001|Reported Event|Eculizumab|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses~Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
10933700|NCT00727220|BG000|Baseline|Insulin Pump Therapy|
10933701|NCT00727220|BG001|Baseline|Insulin Injections|
10933702|NCT00727220|BG002|Baseline|Total|Total of all reporting groups
10933703|NCT00727220|FG000|Participant Flow|Insulin Pump Therapy|
10933704|NCT00727220|FG001|Participant Flow|Insulin Injections|
10933705|NCT00727220|OG000|Outcome|Insulin Pump Therapy|
10933706|NCT00727220|OG001|Outcome|Insulin Injections|
10933707|NCT00727220|EG000|Reported Event|Insulin Pump Therapy|
11176078|NCT02033759|BG001|Baseline|Bio-Impedance Testing|"Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire~Bio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.~Anxiety Questionnaire: 21 item questionnaire~BIS measurements involved the placement of adhesive electrodes on each wrist and the right ankle, followed by connection of the electrodes to the BIS machine (L-Dex U-400, ImpediMed Ltd). The L-Dex uses a painless electrical impulse to measure impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2 upper limbs.6, 9-13 This tool compares readings to normative data to determine if significant asymmetry exists, or if the current reading is >2 standard deviations from the baseline reading for that individual."
11176079|NCT02033759|BG002|Baseline|Total|Total of all reporting groups
10933708|NCT00727220|EG001|Reported Event|Insulin Injections|
10933709|NCT00727246|BG000|Baseline|Participants With TBI Who Received CDP-Choline|Participants with TBI who were randomized to receive the CDP-Choline
10933710|NCT00727246|BG001|Baseline|Participants With TBI Who Received Placebo|Participants with TBI who were randomized to receive Placebo
10933711|NCT00727246|BG002|Baseline|Control Participants Who Received CDP-Choline|Participants without a history of TBI who were randomized to receive CDP-Choline
10933712|NCT00727246|BG003|Baseline|Control Participants Who Received Placebo|Participants without a history of TBI who were randomized to receive placebo
10933713|NCT00727246|BG004|Baseline|Total|Total of all reporting groups
10933714|NCT00727246|FG000|Participant Flow|Participants With TBI Who Received CDP-Choline|Participants who have experienced a TBI and were randomly assigned to receive the study supplement
10933715|NCT00727246|FG001|Participant Flow|Participants With TBI Who Received Placebo|Participants with a history of TBI who were randomly assigned to the placebo group
10933716|NCT00727246|FG002|Participant Flow|Control Participants Who Received CDP-Choline|Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline
10933717|NCT00727246|FG003|Participant Flow|Control Participants Who Received Placebo|Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
10933718|NCT00727246|OG000|Outcome|Participants With TBI Who Received CDP-Choline|Participants with TBI who were randomized to receive the CDP-Choline
10933719|NCT00727246|OG001|Outcome|Participants With TBI Who Received Placebo|Participants with TBI who were randomized to receive Placebo
10933720|NCT00727246|OG002|Outcome|Control Participants Who Received CDP-Choline|Participants without a history of TBI who were randomized to receive CDP-Choline
10933721|NCT00727246|OG003|Outcome|Control Participants Who Received Placebo|Participants without a history of TBI who were randomized to receive placebo
10933722|NCT00727246|EG000|Reported Event|Participants With TBI Who Received CDP-Choline|Participants who have experienced a TBI and were randomly assigned to receive the study supplement
10933723|NCT00727246|EG001|Reported Event|Participants With TBI Who Received Placebo|Participants with a history of TBI who were randomly assigned to the placebo group
10933724|NCT00727246|EG002|Reported Event|Control Participants Who Received CDP-Choline|Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline
10933725|NCT00727246|EG003|Reported Event|Control Participants Who Received Placebo|Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
10933726|NCT00727259|BG000|Baseline|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940).
10933727|NCT00727259|FG000|Participant Flow|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
10933728|NCT00727259|OG000|Outcome|After 1 Month of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
10933729|NCT00727259|OG001|Outcome|After 3 Months of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
10933730|NCT00727259|EG000|Reported Event|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
10933731|NCT00727272|BG000|Baseline|Entire Study Population|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under Fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
11176080|NCT02033759|FG000|Participant Flow|Traditional Circumferential Measurements|"Traditional screening with volumetric analysis Patient Anxiety Questionnaire~Anxiety Questionnaire: 21 item questionnaire~Traditional Circumferential Measurements"
10933732|NCT00727272|FG000|Participant Flow|Treatment Sequence ABC|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933733|NCT00727272|FG001|Participant Flow|Treatment Sequence BCA|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933734|NCT00727272|FG002|Participant Flow|Treatment Sequence CAB|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933735|NCT00727272|OG000|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
10933736|NCT00727272|OG001|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
10933737|NCT00727272|OG002|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
10933738|NCT00727272|OG003|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
10933739|NCT00727272|OG003|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg 30 minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
10933740|NCT00727272|EG000|Reported Event|Treatment A - Quinine Sulfate Capsules 324 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933741|NCT00727272|EG001|Reported Event|Treatment B - Quinine Sulphate Tablets 300 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
10933742|NCT00727272|EG002|Reported Event|Treatment C - Quinine Sulfate Capsules 324 mg - Fed|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
11176081|NCT02033759|FG001|Participant Flow|Bio-Impedance Testing|"Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire~Bio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.~Anxiety Questionnaire: 21 item questionnaire~Traditional Circumferential Measurements"
10933743|NCT00727298|BG000|Baseline|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
11176082|NCT02033759|OG000|Outcome|Traditional Circumferential Measurements|"Traditional screening with volumetric analysis Patient Anxiety Questionnaire~Anxiety Questionnaire: 21 item questionnaire~Traditional Circumferential Measurements"
11176083|NCT02033759|OG001|Outcome|Bio-Impedance Testing|"Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire~Bio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.~Anxiety Questionnaire: 21 item questionnaire~Traditional Circumferential Measurements"
10933744|NCT00727298|FG000|Participant Flow|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
10933745|NCT00727298|OG000|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
10933746|NCT00727298|EG000|Reported Event|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
10933747|NCT00727311|BG000|Baseline|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
10933748|NCT00727311|FG000|Participant Flow|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
10933749|NCT00727311|OG000|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
10933750|NCT00727311|EG000|Reported Event|All Participants|
10933751|NCT00727337|BG000|Baseline|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
10933752|NCT00727337|BG001|Baseline|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
10933753|NCT00727337|BG002|Baseline|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
10933754|NCT00727337|BG003|Baseline|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
10933755|NCT00727337|BG004|Baseline|Total|Total of all reporting groups
10933756|NCT00727337|FG000|Participant Flow|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
10933757|NCT00727337|FG001|Participant Flow|LACE - COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
10933758|NCT00727337|FG002|Participant Flow|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
10933759|NCT00727337|FG003|Participant Flow|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
10933760|NCT00727337|OG000|Outcome|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
10933761|NCT00727337|OG001|Outcome|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
10933762|NCT00727337|OG002|Outcome|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
10933763|NCT00727337|OG003|Outcome|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
10933764|NCT00727337|OG000|Outcome|LACE-DVD|"Participants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode~Lace-DVD: DVD based Auditory Training"
10933765|NCT00727337|OG001|Outcome|LACE-COMPUTER|"Participants will complete a computer-based auditory training program (i.e., LACE)~LACE-computer: Computerized Auditory Training"
10933766|NCT00727337|OG002|Outcome|PLACEBO-DIRECTED LISTENING|"Participants will complete a directed listening to books on CD treatment~PLACEBO-Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
10933767|NCT00727337|OG003|Outcome|CONTROL|"Participants will be provided with hearing aids~CONTROL: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
10933768|NCT00727337|OG001|Outcome|LACE - COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
10933769|NCT00727337|EG000|Reported Event|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
10933770|NCT00727337|EG001|Reported Event|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
10933771|NCT00727337|EG002|Reported Event|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
10933772|NCT00727337|EG003|Reported Event|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
10933773|NCT00727402|BG000|Baseline|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
10933774|NCT00727402|FG000|Participant Flow|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
10933775|NCT00727402|OG000|Outcome|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
10933776|NCT00727402|EG000|Reported Event|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
10933777|NCT00727415|BG000|Baseline|Phase I-II Lenalidomide|"The phase I of the study, carried out at a single center (Hematology, Sapienza University of Rome) was focused at defining the MTD of lenalidomide given in combination with the FC regimen according to a 3 + 3 patient design. During the first course of treatment, lenalidomide was given to all patients at the starting dose of 2.5 mg daily (d1-d14). For the subsequent courses, the dose of lenalidomide was progressively escalated at each course, according to a 3 + 3 patient design. In 3 cohorts of 3 patients each, a daily dose of 5, 10, and 15 mg of lenalidomide was tested unless a dose limiting toxicity (DLT) was experienced.~The presence of a persistent and severe hematologic toxicity, grade 2 tumor lysis syndrome (TLS), grade 3 tumor flare reaction (TFR), or other grade 3 toxicities was defined as DLT.~In the second phase of the study, FC was given in combination with lenalidomide escalated from 2.5 mg to reach the MTD or the maximum planned dose of 15 mg."
10933778|NCT00727415|FG000|Participant Flow|Phase I-II Lenalidomide|"The phase I of the study, carried out at a single center (Hematology, Sapienza University of Rome) was focused at defining the MTD of lenalidomide given in combination with the FC regimen according to a 3 + 3 patient design. During the first course of treatment, lenalidomide was given to all patients at the starting dose of 2.5 mg daily (d1-d14). For the subsequent courses, the dose of lenalidomide was progressively escalated at each course, according to a 3 + 3 patient design. In 3 cohorts of 3 patients each, a daily dose of 5, 10, and 15 mg of lenalidomide was tested unless a dose limiting toxicity (DLT) was experienced.~The presence of a persistent and severe hematologic toxicity, grade 2 tumor lysis syndrome (TLS), grade 3 tumor flare reaction (TFR), or other grade 3 toxicities was defined as DLT.~In the second phase of the study, FC was given in combination with lenalidomide escalated from 2.5 mg to reach the MTD or the maximum planned dose of 15 mg."
10933779|NCT00727415|OG000|Outcome|Phase I-II Lenalidomide|"The phase I of the study, carried out at a single center (Hematology, Sapienza University of Rome) was focused at defining the MTD of lenalidomide given in combination with the FC regimen according to a 3 + 3 patient design. During the first course of treatment, lenalidomide was given to all patients at the starting dose of 2.5 mg daily (d1-d14). For the subsequent courses, the dose of lenalidomide was progressively escalated at each course, according to a 3 + 3 patient design. In 3 cohorts of 3 patients each, a daily dose of 5, 10, and 15 mg of lenalidomide was tested unless a dose limiting toxicity (DLT) was experienced.~The presence of a persistent and severe hematologic toxicity, grade 2 tumor lysis syndrome (TLS), grade 3 tumor flare reaction (TFR), or other grade 3 toxicities was defined as DLT.~In the second phase of the study, FC was given in combination with lenalidomide escalated from 2.5 mg to reach the MTD or the maximum planned dose of 15 mg."
10933780|NCT00727415|EG000|Reported Event|Phase I-II Lenalidomide|"The phase I of the study, carried out at a single center (Hematology, Sapienza University of Rome) was focused at defining the MTD of lenalidomide given in combination with the FC regimen according to a 3 + 3 patient design. During the first course of treatment, lenalidomide was given to all patients at the starting dose of 2.5 mg daily (d1-d14). For the subsequent courses, the dose of lenalidomide was progressively escalated at each course, according to a 3 + 3 patient design. In 3 cohorts of 3 patients each, a daily dose of 5, 10, and 15 mg of lenalidomide was tested unless a dose limiting toxicity (DLT) was experienced.~The presence of a persistent and severe hematologic toxicity, grade 2 tumor lysis syndrome (TLS), grade 3 tumor flare reaction (TFR), or other grade 3 toxicities was defined as DLT.~In the second phase of the study, FC was given in combination with lenalidomide escalated from 2.5 mg to reach the MTD or the maximum planned dose of 15 mg."
10933781|NCT00727441|BG000|Baseline|Arm A - GVAX Vaccine Without Cyclophosphamide|"Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally"
10933782|NCT00727441|BG001|Baseline|Arm B - GVAX Vaccine With IV Cyclophosphamide|"Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles..~GVAX pancreatic cancer vaccine: Given intradermally~cyclophosphamide: Given IV (Arm B), given orally (Arm C)"
10933783|NCT00727441|BG002|Baseline|Arm C - GVAX Vaccine With PO Cyclophosphamide|"Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral (PO) cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally~cyclophosphamide: Given IV (Arm B), given orally (Arm C)"
10933784|NCT00727441|BG003|Baseline|Total|Total of all reporting groups
10933785|NCT00727441|FG000|Participant Flow|Arm A - GVAX Vaccine Without Cyclophosphamide|"Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally"
10933786|NCT00727441|FG001|Participant Flow|Arm B - GVAX Vaccine With IV Cyclophosphamide|"Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles..~GVAX pancreatic cancer vaccine: Given intradermally~Cyclophosphamide: Given IV"
10933787|NCT00727441|FG002|Participant Flow|Arm C - GVAX Vaccine With PO Cyclophosphamide|"Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally~Cyclophosphamide: Given orally"
10933788|NCT00727441|OG000|Outcome|Arm A - GVAX Vaccine Without Cyclophosphamide|"Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally"
10933789|NCT00727441|OG001|Outcome|Arm B - GVAX Vaccine With IV Cyclophosphamide|"Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles..~GVAX pancreatic cancer vaccine: Given intradermally~Cyclophosphamide: Given IV"
10933790|NCT00727441|OG002|Outcome|Arm C - GVAX Vaccine With PO Cyclophosphamide|"Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally~Cyclophosphamide: Given orally"
10933791|NCT00727441|OG000|Outcome|Arm A|"Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally"
10933792|NCT00727441|OG001|Outcome|Arm B|"Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles..~GVAX pancreatic cancer vaccine: Given intradermally~cyclophosphamide: Given IV (Arm B), given orally (Arm C)"
10933793|NCT00727441|OG002|Outcome|Arm C|"Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally~cyclophosphamide: Given IV (Arm B), given orally (Arm C)"
10933794|NCT00727441|EG000|Reported Event|Arm A - GVAX Vaccine Without Cyclophosphamide|"Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally"
10933795|NCT00727441|EG001|Reported Event|Arm B - GVAX Vaccine With IV Cyclophosphamide|"Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles..~GVAX pancreatic cancer vaccine: Given intradermally~cyclophosphamide: Given IV (Arm B), given orally (Arm C)"
11176084|NCT02033759|EG000|Reported Event|Traditional Circumferential Measurements|"Traditional screening with volumetric analysis Patient Anxiety Questionnaire~Anxiety Questionnaire: 21 item questionnaire~Traditional Circumferential Measurements"
11176085|NCT02033759|EG001|Reported Event|Bio-Impedance Testing|"Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire~Bio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.~Anxiety Questionnaire: 21 item questionnaire~Traditional Circumferential Measurements"
10933796|NCT00727441|EG002|Reported Event|Arm C - GVAX Vaccine With PO Cyclophosphamide|"Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles.~GVAX pancreatic cancer vaccine: Given intradermally~cyclophosphamide: Given IV (Arm B), given orally (Arm C)"
10933797|NCT00727506|BG000|Baseline|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
11176086|NCT02033850|BG000|Baseline|APT-II Group|"Intervention: rehabilitation of attention using the Attention Process Training-II.~Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks."
11176087|NCT02033850|BG001|Baseline|Standard Care Group|Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
11176088|NCT02033850|BG002|Baseline|Total|Total of all reporting groups
11176089|NCT02033850|FG000|Participant Flow|APT-II Group|"Intervention: rehabilitation of attention using the Attention Process Training-II.~Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks."
11176090|NCT02033850|FG001|Participant Flow|Standard Care Group|Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
11176091|NCT02033850|OG000|Outcome|APT-II Group|"Intervention: rehabilitation of attention using the Attention Process Training-II.~Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks."
11176092|NCT02033850|OG001|Outcome|Standard Care Group|Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
11176093|NCT02033850|EG000|Reported Event|APT-II Group|"Intervention: rehabilitation of attention using the Attention Process Training-II.~Participants in the APT-II group will receive overall up to 40 hours of individual attention process training. Therapy will be administered in one two-hour session each week over a total of 20 weeks."
11176094|NCT02033850|EG001|Reported Event|Standard Care Group|Participants in the standard care group will not receive cognitive training or rehabilitation interventions, will be instructed to have an usual lifestyle, and will be conventionally provided of medication and clinic consultations
10933798|NCT00727506|BG001|Baseline|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933799|NCT00727506|BG002|Baseline|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
11176095|NCT02033876|BG000|Baseline|Ursodiol|"Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily~Ursodiol"
11176096|NCT02033876|BG001|Baseline|Placebo|"matching placebo capsules to be taken twice daily~Ursodiol"
11176097|NCT02033876|BG002|Baseline|Total|Total of all reporting groups
11176098|NCT02033876|FG000|Participant Flow|Ursodiol|"Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily~Ursodiol"
11176099|NCT02033876|FG001|Participant Flow|Placebo|"matching placebo capsules to be taken twice daily~Ursodiol"
11176100|NCT02033876|OG000|Outcome|Ursodiol|"Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily~Ursodiol"
11176101|NCT02033876|OG001|Outcome|Placebo|"matching placebo capsules to be taken twice daily~Ursodiol"
11176102|NCT02033876|EG000|Reported Event|Ursodiol|"Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily~Ursodiol"
11176103|NCT02033876|EG001|Reported Event|Placebo|"matching placebo capsules to be taken twice daily~Ursodiol"
11176104|NCT02033889|BG000|Baseline|Placebo/Glimepiride|Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176105|NCT02033889|BG001|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176106|NCT02033889|BG002|Baseline|Ertugliflozin 15 mg|Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176107|NCT02033889|BG003|Baseline|Total|Total of all reporting groups
10933800|NCT00727506|BG003|Baseline|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
10933801|NCT00727506|BG004|Baseline|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
10933802|NCT00727506|BG005|Baseline|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
10933803|NCT00727506|BG006|Baseline|Total|Total of all reporting groups
10933804|NCT00727506|FG000|Participant Flow|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933805|NCT00727506|FG001|Participant Flow|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933806|NCT00727506|FG002|Participant Flow|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933807|NCT00727506|FG003|Participant Flow|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
10933808|NCT00727506|FG004|Participant Flow|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
10933809|NCT00727506|FG005|Participant Flow|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
10933810|NCT00727506|OG000|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933811|NCT00727506|OG001|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933812|NCT00727506|OG002|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933813|NCT00727506|OG000|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
10933814|NCT00727506|OG001|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
10933815|NCT00727506|OG002|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
10933816|NCT00727506|OG000|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of temozolomide).
10933817|NCT00727506|OG001|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of temozolomide).
10933818|NCT00727506|OG000|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
10933819|NCT00727506|OG001|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
10933820|NCT00727506|OG000|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
10933821|NCT00727506|OG001|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
10933822|NCT00727506|EG000|Reported Event|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933823|NCT00727506|EG001|Reported Event|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933824|NCT00727506|EG002|Reported Event|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
10933825|NCT00727506|EG003|Reported Event|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
10933826|NCT00727506|EG004|Reported Event|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
10933827|NCT00727506|EG005|Reported Event|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part.
10933828|NCT00727532|BG000|Baseline|Sorafenib|Sorafenib 400mg orally twice daily on days 1-28
10933829|NCT00727532|FG000|Participant Flow|Sorafenib|"Sorafenib 400mg orally twice daily on days 1-28~sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days~diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment"
10933830|NCT00727532|OG000|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily on days 1-28~sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days~diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment"
10933831|NCT00727532|EG000|Reported Event|Sorafenib|"Sorafenib 400mg orally twice daily on days 1-28~sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days~diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment"
10933832|NCT00727558|BG000|Baseline|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
10933833|NCT00727558|BG001|Baseline|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
10933834|NCT00727558|BG002|Baseline|Total|Total of all reporting groups
10933835|NCT00727558|FG000|Participant Flow|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
10933836|NCT00727558|FG001|Participant Flow|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
10933837|NCT00727558|OG000|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
10933838|NCT00727558|OG001|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
10933839|NCT00727558|EG000|Reported Event|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
10933840|NCT00727558|EG001|Reported Event|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
10933841|NCT00727571|BG000|Baseline|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933842|NCT00727571|BG001|Baseline|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933843|NCT00727571|BG002|Baseline|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933844|NCT00727571|BG003|Baseline|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933845|NCT00727571|BG004|Baseline|Total|Total of all reporting groups
10933846|NCT00727571|FG000|Participant Flow|No CKD or Anemia|Chronic kidney disease (CKD) is based on an estimated Glomerular Filtration Rate (GFR), calculated by the Modification of Diet in Renal Disease (MDRD) method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per World Health Organization (WHO) criteria. Participants completed the study after Week 1; data contributed to prevalence estimates.
10933847|NCT00727571|FG001|Participant Flow|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments.
11240687|NCT02481219|FG001|Participant Flow|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
10933848|NCT00727571|FG002|Participant Flow|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed mobility and physical performance assessments.
10933849|NCT00727571|FG003|Participant Flow|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
10933850|NCT00727571|OG000|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933851|NCT00727571|OG001|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933852|NCT00727571|OG000|Outcome|All Enrolled Participants|
10933853|NCT00727571|OG001|Outcome|No CKD But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933854|NCT00727571|EG000|Reported Event|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933855|NCT00727571|EG001|Reported Event|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933856|NCT00727571|EG002|Reported Event|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
10933857|NCT00727571|EG003|Reported Event|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
10933858|NCT00727597|BG000|Baseline|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
10933859|NCT00727597|BG001|Baseline|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
10933860|NCT00727597|BG002|Baseline|Total|Total of all reporting groups
10933861|NCT00727597|FG000|Participant Flow|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
10933862|NCT00727597|FG001|Participant Flow|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
10933863|NCT00727597|OG000|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
10933864|NCT00727597|OG001|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
10933865|NCT00727597|EG000|Reported Event|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
10933866|NCT00727597|EG001|Reported Event|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
10933867|NCT00727636|BG000|Baseline|Prospective Cohort|Received Gardasil as part of study
10933868|NCT00727636|BG001|Baseline|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
10933869|NCT00727636|BG002|Baseline|Total|Total of all reporting groups
10933870|NCT00727636|FG000|Participant Flow|Prospective Cohort|Received Gardasil as part of study
10933871|NCT00727636|FG001|Participant Flow|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
10933872|NCT00727636|OG000|Outcome|Prospective Cohort|Received Gardasil as part of study
10933873|NCT00727636|OG001|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
10933874|NCT00727636|EG000|Reported Event|Prospective Cohort|Received Gardasil as part of study
10933875|NCT00727636|EG001|Reported Event|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
10933876|NCT00727649|BG000|Baseline|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 2 mg placebo daily with weekly dose adjustments for side-effects and/or efficacy"
10933877|NCT00727649|BG001|Baseline|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg pill~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
10933878|NCT00727649|BG002|Baseline|Total|Total of all reporting groups
10933879|NCT00727649|FG000|Participant Flow|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
10933880|NCT00727649|FG001|Participant Flow|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
10933881|NCT00727649|OG000|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
10933882|NCT00727649|OG001|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
10933883|NCT00727649|EG000|Reported Event|P1L2 (Psyllium First); 1st 4-weeks|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
10933884|NCT00727649|EG001|Reported Event|L1P2 (Loperamide First): 1st 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
10933885|NCT00727649|EG002|Reported Event|P1L2 (Loperamide Second); 2nd 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
10933886|NCT00727649|EG003|Reported Event|L1P2 (Psyllium Second); 2nd 4-weeks|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
10933887|NCT00727714|BG000|Baseline|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
10933888|NCT00727714|FG000|Participant Flow|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
10933889|NCT00727714|OG000|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
10933890|NCT00727714|EG000|Reported Event|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
10933891|NCT00727740|BG000|Baseline|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
10933892|NCT00727740|BG001|Baseline|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
10933893|NCT00727740|BG002|Baseline|Total|Total of all reporting groups
10933894|NCT00727740|FG000|Participant Flow|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
10933895|NCT00727740|FG001|Participant Flow|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
10933896|NCT00727740|OG000|Outcome|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
10933897|NCT00727740|OG001|Outcome|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
10933898|NCT00727740|EG000|Reported Event|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
10933899|NCT00727740|EG001|Reported Event|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
10933900|NCT00727844|BG000|Baseline|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
10933901|NCT00727844|BG001|Baseline|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
10933902|NCT00727844|BG002|Baseline|Total|Total of all reporting groups
10933903|NCT00727844|FG000|Participant Flow|Initial Randomization: Immediate Start Linezolid|Upon completion of entry criteria, subjects immediately added linezolid 600 mg once daily to their ongoing TB treatment regimen.
10933904|NCT00727844|FG001|Participant Flow|Initial Randomization: Delayed Start Linezolid|Subjects continued their existing treatment regimen for 2 additional months after which linezolid 600 mg once daily was added.
10933905|NCT00727844|FG002|Participant Flow|2nd Randomization: Linezolid 600 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
10933906|NCT00727844|FG003|Participant Flow|2nd Randomization: Linezolid 300 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
10933907|NCT00727844|OG000|Outcome|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
10933908|NCT00727844|OG001|Outcome|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
10933909|NCT00727844|EG000|Reported Event|Clinically Significant AEs|All clinically significant adverse events, regardless of relationship to linezolid. This includes all SAEs, all AEs grade 3 and above, and all neuropathies grade 2 and above.
10933910|NCT00727857|BG000|Baseline|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
10933911|NCT00727857|BG001|Baseline|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
10933912|NCT00727857|BG002|Baseline|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
10933913|NCT00727857|BG003|Baseline|Total|Total of all reporting groups
10933914|NCT00727857|FG000|Participant Flow|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
10933915|NCT00727857|FG001|Participant Flow|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
10933916|NCT00727857|FG002|Participant Flow|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
10933917|NCT00727857|OG000|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
10933918|NCT00727857|OG001|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
10933919|NCT00727857|OG002|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
10933920|NCT00727857|OG000|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg/Metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
10933921|NCT00727857|EG000|Reported Event|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
10933922|NCT00727857|EG001|Reported Event|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
10933923|NCT00727857|EG002|Reported Event|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
10963360|NCT00871689|EG000|Reported Event|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
10963361|NCT00871715|BG000|Baseline|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
10963362|NCT00871715|BG001|Baseline|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
10963363|NCT00871715|BG002|Baseline|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
10963364|NCT00871715|BG003|Baseline|Total|Total of all reporting groups
10963365|NCT00871715|FG000|Participant Flow|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
10933924|NCT00727909|BG000|Baseline|All Study Participants|All study participants received all three hearing aid treatments (TC, RITA, RITE). The sequence of treatments was counter-balanced to prevent an order effect. Each hearing aid treatment lasted two months. Each treatment period was followed by the administration of a series of outcome measures before the next treatment was begun. At the conclusion of the third treatment, in addition to administration of the outcome measures, the participants were asked to rank the three hearing aid treatments in order of preference, and to provide subjective comments regarding the rationale for their rank-ordering.
10933925|NCT00727909|FG000|Participant Flow|TC RITE RITA|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Ear (RITE), followed by Receiver in the Aid (RITA). The length of each hearing aid treatment condition was 2 months.
10933926|NCT00727909|FG001|Participant Flow|TC RITA RITE|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Aid (RITA), followed by Receiver in the Ear (RITE). The length of each hearing aid treatment condition was 2 months.
10933927|NCT00727909|FG002|Participant Flow|RITE RITA TC|Participants received the Receiver in the Ear (RITE) hearing aid first, followed by Receiver in the Aid (RITA), followed by Traditional Custom hearing aid (TC). The length of each hearing aid treatment condition was 2 months.
10933928|NCT00727909|FG003|Participant Flow|RITA RITE TC|Participants received the Receiver in the Aid (RITA) hearing aid first, followed by Receiver in the Ear (RITE), followed by Traditional Custom (TC). The length of each hearing aid treatment condition was 2 months.
10933929|NCT00727909|OG000|Outcome|All Participants|All participants received all three hearing aid treatments.
10933930|NCT00727909|EG000|Reported Event|All Study Participants|All participants received all three hearing aid treatments.
10933931|NCT00727961|BG000|Baseline|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
10933932|NCT00727961|FG000|Participant Flow|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
10933933|NCT00727961|OG000|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
10933934|NCT00727961|EG000|Reported Event|Caelyx Intravenous|
10933935|NCT00728130|BG000|Baseline|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
10933936|NCT00728130|FG000|Participant Flow|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
10933937|NCT00728130|OG000|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
10933938|NCT00728130|EG000|Reported Event|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
10933939|NCT00728182|BG000|Baseline|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
10933940|NCT00728182|BG001|Baseline|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
10933941|NCT00728182|BG002|Baseline|Total|Total of all reporting groups
10933942|NCT00728182|FG000|Participant Flow|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
10933943|NCT00728182|FG001|Participant Flow|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
10933944|NCT00728182|OG000|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
10933945|NCT00728182|OG001|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
10933946|NCT00728182|OG000|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
10933947|NCT00728182|OG001|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
10933948|NCT00728182|EG000|Reported Event|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
10933949|NCT00728182|EG001|Reported Event|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
10933950|NCT00728260|BG000|Baseline|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
10933951|NCT00728260|FG000|Participant Flow|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
10933952|NCT00728260|OG000|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
10933953|NCT00728260|EG000|Reported Event|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
10933954|NCT00728468|BG000|Baseline|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
10933955|NCT00728468|FG000|Participant Flow|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
10933956|NCT00728468|OG000|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
10933957|NCT00728468|EG000|Reported Event|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
10933958|NCT00728481|BG000|Baseline|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
10933959|NCT00728481|BG001|Baseline|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
10933960|NCT00728481|BG002|Baseline|Total|Total of all reporting groups
10933961|NCT00728481|FG000|Participant Flow|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
10933962|NCT00728481|FG001|Participant Flow|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
10933963|NCT00728481|OG000|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
10933964|NCT00728481|OG001|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
10933965|NCT00728481|EG000|Reported Event|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
10933966|NCT00728481|EG001|Reported Event|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
10933967|NCT00728494|BG000|Baseline|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
10933968|NCT00728494|BG001|Baseline|Treatment Alone|PegIntron/Rebetol treatment only
10933969|NCT00728494|BG002|Baseline|Total|Total of all reporting groups
10933970|NCT00728494|FG000|Participant Flow|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
10933971|NCT00728494|FG001|Participant Flow|Treatment Alone|PegIntron/Rebetol treatment only
10933972|NCT00728494|OG000|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
10933973|NCT00728494|OG001|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
10933974|NCT00728494|EG000|Reported Event|Treatment and Patient Assistance Program|
10933975|NCT00728494|EG001|Reported Event|Treatment Alone|
10933976|NCT00728507|BG000|Baseline|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
11176108|NCT02033889|FG000|Participant Flow|Placebo/Glimepiride|Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
10933977|NCT00728507|BG001|Baseline|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
10933978|NCT00728507|BG002|Baseline|Total|Total of all reporting groups
10933979|NCT00728507|FG000|Participant Flow|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
10933980|NCT00728507|FG001|Participant Flow|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
10933981|NCT00728507|OG000|Outcome|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
10933982|NCT00728507|OG001|Outcome|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
10933983|NCT00728507|EG000|Reported Event|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
10933984|NCT00728507|EG001|Reported Event|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
10933985|NCT00728689|BG000|Baseline|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
10933986|NCT00728689|BG001|Baseline|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
11176109|NCT02033889|FG001|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
10933987|NCT00728689|BG002|Baseline|Total|Total of all reporting groups
10933988|NCT00728689|FG000|Participant Flow|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
10933989|NCT00728689|FG001|Participant Flow|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
10933990|NCT00728689|OG000|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
10933991|NCT00728689|OG001|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
10933992|NCT00728689|OG000|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
10933993|NCT00728689|OG001|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
10933994|NCT00728689|EG000|Reported Event|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
10933995|NCT00728689|EG001|Reported Event|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
10933996|NCT00728728|BG000|Baseline|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
10933997|NCT00728728|BG001|Baseline|Arm 2: Placebo|Placebo control group
10933998|NCT00728728|BG002|Baseline|Total|Total of all reporting groups
10933999|NCT00728728|FG000|Participant Flow|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
10934000|NCT00728728|FG001|Participant Flow|Arm 2: Placebo|Placebo control group
10934001|NCT00728728|OG000|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
10934002|NCT00728728|OG001|Outcome|Arm 2: Placebo|Placebo control group
10934003|NCT00728728|OG001|Outcome|Arm 2: Placebo|Placebo: Placebo
10934004|NCT00728728|EG000|Reported Event|Arm 1: Pregnenolone|"Pregnenolone~Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial."
10934005|NCT00728728|EG001|Reported Event|Arm 2: Placebo|"Placebo~Placebo: Placebo"
10934006|NCT00728819|BG000|Baseline|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
10934007|NCT00728819|BG001|Baseline|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
10934008|NCT00728819|BG002|Baseline|Total|Total of all reporting groups
10934009|NCT00728819|FG000|Participant Flow|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
10934010|NCT00728819|FG001|Participant Flow|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
10934011|NCT00728819|OG000|Outcome|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
10934012|NCT00728819|OG001|Outcome|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
10934013|NCT00728819|EG000|Reported Event|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
10934014|NCT00728819|EG001|Reported Event|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
10934015|NCT00728910|BG000|Baseline|Group 1|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks.
11240688|NCT02481219|OG000|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
10934016|NCT00728910|FG000|Participant Flow|Atorvastatin/ABT335/Niaspan|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks, for a total study duration of 22 weeks
10934017|NCT00728910|OG000|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
10934018|NCT00728910|OG001|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
10934019|NCT00728910|OG002|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
10934020|NCT00728910|OG000|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by an oral fat tolerance test
10934021|NCT00728910|OG001|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks followed by an oral fat tolerance test.
10934022|NCT00728910|OG002|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks followed by an oral fat tolerance test.
10934023|NCT00728910|EG000|Reported Event|Atorvastatin/ABT335/Niaspan|Subjects received atorvastatin 10 mg/day for 4 weeks, followed by addition of ABT335 135 mg/day for a further 8 weeks followed by the addition of Niaspan 2000 mg/day for a further 10 weeks.
10934024|NCT00728923|BG000|Baseline|Minocycline|minocycline 100mg bid for 12 weeks
10934025|NCT00728923|FG000|Participant Flow|Minocycline|minocycline 100mg bid for 12 weeks
10934026|NCT00728923|OG000|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
10934027|NCT00728923|EG000|Reported Event|Minocycline|minocycline 100mg bid for 12 weeks
10934028|NCT00728936|BG000|Baseline|Placebo|"Weekly saline placebo~Saline placebo: saline placebo given subcutaneously"
10934029|NCT00728936|BG001|Baseline|IMO-2125 0.04 mg/kg q Week|"IMO-2125 given weekly at 0.04 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934030|NCT00728936|BG002|Baseline|IMO-2125 0.08 mg/kg q Week|"IMO-2125 given weekly at 0.08 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934031|NCT00728936|BG003|Baseline|IMO-2125 0.16 mg/kg q Week|"IMO-2125 given weekly at 0.16 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934032|NCT00728936|BG004|Baseline|IMO-2125 0.32 mg/kg q Week|"IMO-2125 given weekly at 0.32 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934033|NCT00728936|BG005|Baseline|IMO-2125 0.48 mg/kg q Week|"IMO-2125 given weekly at 0.48 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934034|NCT00728936|BG006|Baseline|IMO-2125 0.16 mg/kg Twice a Week|"IMO-2125 given twice a week at 0.16 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934035|NCT00728936|BG007|Baseline|Total|Total of all reporting groups
10934036|NCT00728936|FG000|Participant Flow|Placebo|"Weekly saline placebo~Saline placebo: saline placebo given subcutaneously"
10934037|NCT00728936|FG001|Participant Flow|IMO-2125 0.04 mg/kg q Week|"IMO-2125 given weekly at 0.04 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934038|NCT00728936|FG002|Participant Flow|IMO-2125 0.08 mg/kg q Week|"IMO-2125 given weekly at 0.08 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934039|NCT00728936|FG003|Participant Flow|IMO-2125 0.16 mg/kg q Week|"IMO-2125 given weekly at 0.16 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934040|NCT00728936|FG004|Participant Flow|IMO-2125 0.32 mg/kg q Week|"IMO-2125 given weekly at 0.32 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934041|NCT00728936|FG005|Participant Flow|IMO-2125 0.48 mg/kg q Week|"IMO-2125 given weekly at 0.48 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934042|NCT00728936|FG006|Participant Flow|IMO-2125 0.16 mg/kg Twice a Week|"IMO-2125 given twice a week at 0.16 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934043|NCT00728936|OG000|Outcome|Placebo|"Weekly saline placebo~Saline placebo: saline placebo given subcutaneously"
10934044|NCT00728936|OG001|Outcome|IMO-2125 0.04 mg/kg q Week|"IMO-2125 given weekly at 0.04 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934045|NCT00728936|OG002|Outcome|IMO-2125 0.08 mg/kg q Week|"IMO-2125 given weekly at 0.08 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934046|NCT00728936|OG003|Outcome|IMO-2125 0.16 mg/kg q Week|"IMO-2125 given weekly at 0.16 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934047|NCT00728936|OG004|Outcome|IMO-2125 0.32 mg/kg q Week|"IMO-2125 given weekly at 0.32 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934048|NCT00728936|OG005|Outcome|IMO-2125 0.48 mg/kg q Week|"IMO-2125 given weekly at 0.48 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934049|NCT00728936|OG006|Outcome|IMO-2125 0.16 mg/kg Twice a Week|"IMO-2125 given twice a week at 0.16 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934050|NCT00728936|EG000|Reported Event|Placebo|"Weekly saline placebo~Saline placebo: saline placebo given subcutaneously"
10934051|NCT00728936|EG001|Reported Event|IMO-2125 0.04 mg/kg q Week|"IMO-2125 given weekly at 0.04 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934052|NCT00728936|EG002|Reported Event|IMO-2125 0.08 mg/kg q Week|"IMO-2125 given weekly at 0.08 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934053|NCT00728936|EG003|Reported Event|IMO-2125 0.16 mg/kg q Week|"IMO-2125 given weekly at 0.16 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934054|NCT00728936|EG004|Reported Event|IMO-2125 0.32 mg/kg q Week|"IMO-2125 given weekly at 0.32 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934055|NCT00728936|EG005|Reported Event|IMO-2125 0.48 mg/kg q Week|"IMO-2125 given weekly at 0.48 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934056|NCT00728936|EG006|Reported Event|IMO-2125 0.16 mg/kg Twice a Week|"IMO-2125 given twice a week at 0.16 mg/kg~IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system"
10934057|NCT00728949|BG000|Baseline|IMC-A12 (Cixutumumab) + Antiestrogen Therapy|Participants will receive intravenous IMC-A12 10 mg/kg over 1 hour every 2 weeks, as well as the same dose and schedule of the last antiestrogen therapy to which their disease became refractory.
10934058|NCT00728949|BG001|Baseline|IMC-A12 (Cixutumumab)|Participants will receive only IMC-A12 (10 mg/kg over 1 hour every 2 weeks).
10934059|NCT00728949|BG002|Baseline|Total|Total of all reporting groups
10934060|NCT00728949|FG000|Participant Flow|IMC-A12 (Cixutumumab) + Antiestrogen Therapy|Participants will receive intravenous IMC-A12 10 mg/kg over 1 hour every 2 weeks, as well as the same dose and schedule of the last antiestrogen therapy to which their disease became refractory.
10934061|NCT00728949|FG001|Participant Flow|IMC-A12 (Cixutumumab)|Participants will receive only IMC-A12 (10 mg/kg over 1 hour every 2 weeks).
10934062|NCT00728949|OG000|Outcome|IMC-A12 (Cixutumumab) + Antiestrogen Therapy|Participants will receive intravenous IMC-A12 10 mg/kg over 1 hour every 2 weeks, as well as the same dose and schedule of the last antiestrogen therapy to which their disease became refractory.
10934063|NCT00728949|OG001|Outcome|IMC-A12 (Cixutumumab)|Participants will receive only IMC-A12 (10 mg/kg over 1 hour every 2 weeks).
10934064|NCT00728949|EG000|Reported Event|IMC-A12 (Cixutumumab) + Antiestrogen Therapy|Participants will receive intravenous IMC-A12 10 mg/kg over 1 hour every 2 weeks, as well as the same dose and schedule of the last antiestrogen therapy to which their disease became refractory.
10934065|NCT00728949|EG001|Reported Event|IMC-A12 (Cixutumumab)|Participants will receive only IMC-A12 (10 mg/kg over 1 hour every 2 weeks).
10934066|NCT00728988|BG000|Baseline|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
10934067|NCT00728988|BG001|Baseline|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
10934068|NCT00728988|BG002|Baseline|Total|Total of all reporting groups
10934069|NCT00728988|FG000|Participant Flow|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
10934070|NCT00728988|FG001|Participant Flow|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
10934071|NCT00728988|OG000|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
10934072|NCT00728988|OG001|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
10934073|NCT00728988|OG000|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
10934074|NCT00728988|EG000|Reported Event|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
10934075|NCT00728988|EG001|Reported Event|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
10934076|NCT00729053|BG000|Baseline|Previous Treatment, 0.16mg/kg|"Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934077|NCT00729053|BG001|Baseline|Previous Treatment, 0.64mg/kg|"Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934078|NCT00729053|BG002|Baseline|Treatment Naive, 0.16mg/kg|"Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934079|NCT00729053|BG003|Baseline|Treatment Naive, 0.64mg/kg|"Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934080|NCT00729053|BG004|Baseline|Total|Total of all reporting groups
10934081|NCT00729053|FG000|Participant Flow|Previous Treatment, 0.16mg/kg|"Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934082|NCT00729053|FG001|Participant Flow|Previous Treatment, 0.64mg/kg|"Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934083|NCT00729053|FG002|Participant Flow|Treatment Naive, 0.16mg/kg|"Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934084|NCT00729053|FG003|Participant Flow|Treatment Naive, 0.64mg/kg|"Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934085|NCT00729053|OG000|Outcome|Previous Treatment, 0.16mg/kg|"Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934086|NCT00729053|OG001|Outcome|Previous Treatment, 0.64mg/kg|"Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934087|NCT00729053|OG002|Outcome|Treatment Naive, 0.16mg/kg|"Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934088|NCT00729053|OG003|Outcome|Treatment Naive, 0.64mg/kg|"Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934089|NCT00729053|EG000|Reported Event|Previous Treatment, 0.16mg/kg|"Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934090|NCT00729053|EG001|Reported Event|Previous Treatment, 0.64mg/kg|"Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934091|NCT00729053|EG002|Reported Event|Treatment Naive, 0.16mg/kg|"Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg~IMO-2055: immunostimulatory oligonucleotide"
11176110|NCT02033889|FG002|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176111|NCT02033889|OG000|Outcome|Placebo/Glimepiride|Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176112|NCT02033889|OG001|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176113|NCT02033889|OG002|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
10934092|NCT00729053|EG003|Reported Event|Treatment Naive, 0.64mg/kg|"Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg~IMO-2055: immunostimulatory oligonucleotide"
10934093|NCT00729157|BG000|Baseline|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
10934094|NCT00729157|FG000|Participant Flow|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
10934095|NCT00729157|OG000|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
11176114|NCT02033889|EG000|Reported Event|Placebo/Glimepiride|Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176115|NCT02033889|EG001|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176116|NCT02033889|EG002|Reported Event|Ertugliflozin 15 mg|Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
11176117|NCT02033993|BG000|Baseline|Arm 1|"Nab-Paclitaxel - 260mg/m2: q21 days~Nab-Paclitaxel"
11176118|NCT02033993|BG001|Baseline|Arm 2|"Paclitaxel - 175mg/m2: q21 days~Paclitaxel"
11176119|NCT02033993|BG002|Baseline|Total|Total of all reporting groups
11176120|NCT02033993|FG000|Participant Flow|Arm 1|"Nab-Paclitaxel - 260mg/m2: q21 days~Nab-Paclitaxel"
10934096|NCT00729157|EG000|Reported Event|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
10934097|NCT00729183|BG000|Baseline|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
10934098|NCT00729183|BG001|Baseline|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
10934099|NCT00729183|BG002|Baseline|Total|Total of all reporting groups
10934100|NCT00729183|FG000|Participant Flow|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
10934101|NCT00729183|FG001|Participant Flow|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
10934102|NCT00729183|OG000|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
10934103|NCT00729183|OG001|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
10934104|NCT00729183|EG000|Reported Event|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
10934105|NCT00729183|EG001|Reported Event|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
10934106|NCT00729248|BG000|Baseline|All Participants|"All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:~Recipient PMBC + Donor PBMC + No drug Recipient PMBC + Donor PBMC + Tacrolimus (TAC) Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
10934107|NCT00729248|FG000|Participant Flow|Participants|12 participants were recruited/consented for the study. 2 subjects (donor/recipient pair) were withdrawn from the study. Ten participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
10934108|NCT00729248|OG000|Outcome|MLRs in the Presence of TAC|"All participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:~REcipient PMBC + Donor PBMC + Tacrolimus (TAC)"
10934109|NCT00729248|OG001|Outcome|MLRs in the Presence of SRL|"All participants (5 donors, 5 recipietns) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in teh following combination:~Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
10934110|NCT00729248|EG000|Reported Event|All Participants|All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
10934111|NCT00729326|BG000|Baseline|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
10934112|NCT00729326|BG001|Baseline|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
10934113|NCT00729326|BG002|Baseline|Total|Total of all reporting groups
10934114|NCT00729326|FG000|Participant Flow|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
10934115|NCT00729326|FG001|Participant Flow|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
10934116|NCT00729326|OG000|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
10934117|NCT00729326|OG001|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
10934118|NCT00729326|EG000|Reported Event|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
10934119|NCT00729326|EG001|Reported Event|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
11176121|NCT02033993|FG001|Participant Flow|Arm 2|"Paclitaxel - 175mg/m2: q21 days~Paclitaxel"
11176122|NCT02033993|OG000|Outcome|Arm 1|"Nab-Paclitaxel - 260mg/m2: q21 days~Nab-Paclitaxel"
11176123|NCT02033993|OG001|Outcome|Arm 2|"Paclitaxel - 175mg/m2: q21 days~Paclitaxel"
10934120|NCT00729378|BG000|Baseline|Exercise Intervention|"Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
10934121|NCT00729378|BG001|Baseline|Control|Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
10934122|NCT00729378|BG002|Baseline|Total|Total of all reporting groups
10934123|NCT00729378|FG000|Participant Flow|Exercise Intervention|"Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
10934124|NCT00729378|FG001|Participant Flow|Control|Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
10934125|NCT00729378|OG000|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
10934126|NCT00729378|OG001|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
10934127|NCT00729378|OG000|Outcome|Exercise Intervention Group|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
10934128|NCT00729378|OG001|Outcome|Control Group|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
10934129|NCT00729378|OG000|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).~."
10934130|NCT00729378|EG000|Reported Event|Exercise Intervention Arm|"Implementation of intervention program designed to provide skeletal loading through high impact activities.~Skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities will be introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years."
10934131|NCT00729378|EG001|Reported Event|Control Arm|Participants in this arm will not take part in intervention exercises. All activities performed by subjects in control arm will be assessed by physical activity questionnaire and use of pedometer.
10934132|NCT00729430|BG000|Baseline|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
10934133|NCT00729430|BG001|Baseline|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
10934134|NCT00729430|BG002|Baseline|Total|Total of all reporting groups
10934135|NCT00729430|FG000|Participant Flow|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
10934136|NCT00729430|FG001|Participant Flow|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
10934137|NCT00729430|OG000|Outcome|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
10934138|NCT00729430|OG001|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
10934139|NCT00729430|OG000|Outcome|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
11176124|NCT02033993|EG000|Reported Event|Arm 1|"Nab-Paclitaxel - 260mg/m2: q21 days~Nab-Paclitaxel"
11176125|NCT02033993|EG001|Reported Event|Arm 2|"Paclitaxel - 175mg/m2: q21 days~Paclitaxel"
10934140|NCT00729430|EG000|Reported Event|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
10934141|NCT00729430|EG001|Reported Event|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
10934142|NCT00729469|BG000|Baseline|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
10934143|NCT00729469|BG001|Baseline|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
10934144|NCT00729469|BG002|Baseline|Total|Total of all reporting groups
10934145|NCT00729469|FG000|Participant Flow|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
10934146|NCT00729469|FG001|Participant Flow|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
10934147|NCT00729469|OG000|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
10934148|NCT00729469|OG001|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
10934149|NCT00729469|EG000|Reported Event|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
10934150|NCT00729469|EG001|Reported Event|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
10934151|NCT00729482|BG000|Baseline|RAD001|Treatment Arm (RAD001)
10934152|NCT00729482|FG000|Participant Flow|RAD001|Treatment Arm (RAD001) take RAD001 10mg/day dose (two 5mg tablets) orally evert day with a glass of water at the same time each day in a fasting state or with a light fat-free meal.
10934153|NCT00729482|OG000|Outcome|RAD001|Treatment Arm (RAD001)
10934154|NCT00729482|EG000|Reported Event|RAD001|Treatment Arm (RAD001)
10934155|NCT00729521|BG000|Baseline|Control|a control group of 10 communities and their residents over 65 years of age receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
10934156|NCT00729521|BG001|Baseline|Standard Program|"a Standard Program group of five communities and their residents over 65 years of age receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
10934157|NCT00729521|BG002|Baseline|Facilitative System|"a Facilitative System group of five communities and their residents over 65 years of age receiving support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
10934158|NCT00729521|BG003|Baseline|Total|Total of all reporting groups
10934159|NCT00729521|FG000|Participant Flow|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
10934160|NCT00729521|FG001|Participant Flow|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
10934161|NCT00729521|FG002|Participant Flow|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
10934162|NCT00729521|OG000|Outcome|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
10934163|NCT00729521|OG001|Outcome|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
10934164|NCT00729521|OG002|Outcome|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
10934165|NCT00729521|EG000|Reported Event|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
10934166|NCT00729521|EG001|Reported Event|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
10934167|NCT00729521|EG002|Reported Event|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
10934168|NCT00729586|BG000|Baseline|Arm 1: Temsirolimus|Temsirolimus IV 25 mg (flat dose) weekly
10934169|NCT00729586|BG001|Baseline|Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus|Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
10934170|NCT00729586|BG002|Baseline|Total|Total of all reporting groups
10934171|NCT00729586|FG000|Participant Flow|Arm 1: Temsirolimus|Temsirolimus IV 25 mg (flat dose) weekly
10934172|NCT00729586|FG001|Participant Flow|Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus|Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
11176126|NCT02034006|BG000|Baseline|Ranibizumab: Treated Once|Patients treated only once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection.
10934173|NCT00729586|OG000|Outcome|Arm 1: Temsirolimus|Temsirolimus IV 25 mg (flat dose) weekly
10934174|NCT00729586|OG001|Outcome|Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus|Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
10934175|NCT00729586|OG000|Outcome|Receptor Analysis|Eligible and treated patients with primary tumor specimen
10934176|NCT00729586|EG000|Reported Event|Arm 1: Temsirolimus|Temsirolimus IV 25 mg (flat dose) weekly
10934177|NCT00729586|EG001|Reported Event|Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus|Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
10934178|NCT00729612|BG000|Baseline|Treatment (Nab-paclitaxel, Carboplatin)|"Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~carboplatin~paclitaxel albumin-stabilized nanoparticle formulation~protein expression analysis~immunoenzyme technique~immunohistochemistry staining method~laboratory biomarker analysis"
10934179|NCT00729612|FG000|Participant Flow|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10934180|NCT00729612|OG000|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10934181|NCT00729612|EG000|Reported Event|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11176127|NCT02034006|BG001|Baseline|Ranibizumab: Re-treated Once|Patients treated more than once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection.
11176128|NCT02034006|BG002|Baseline|Total|Total of all reporting groups
11176129|NCT02034006|FG000|Participant Flow|Ranibizumab|All subjects who received at least one dose of ranibizumab
11176130|NCT02034006|OG000|Outcome|Ranibizumab: Treated Once|Patients treated only once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection.
11176131|NCT02034006|OG001|Outcome|Ranibizumab: Re-treated Once|Patients treated more than once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection.
11176132|NCT02034006|OG000|Outcome|Ranibizumab|Patients treated with a single ranibizumab 0.5 mg/0.05ml intravitreal injection. Further injections might be required when monitoring reveals disease activity.
10934182|NCT00729677|BG000|Baseline|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
10934183|NCT00729677|FG000|Participant Flow|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
10934184|NCT00729677|OG000|Outcome|Females|females starting chemotherapy for stage 3 or 4 colorectal cancer with regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
10934185|NCT00729677|OG001|Outcome|Males|males starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
10934186|NCT00729677|OG002|Outcome|Transgender|transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
10934187|NCT00729677|OG000|Outcome|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
10934188|NCT00729677|OG000|Outcome|Participants With History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had history of nausea.
11176133|NCT02034006|OG000|Outcome|Ranibizumab: Re-treated Once|Patients treated more than once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection.
10934189|NCT00729677|OG001|Outcome|Participants With No History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had no history of nausea.
10934190|NCT00729677|OG000|Outcome|Participants on 2-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
10934191|NCT00729677|OG001|Outcome|Participants on 3-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
10934192|NCT00729677|EG000|Reported Event|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
10934193|NCT00729690|BG000|Baseline|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
10934194|NCT00729690|BG001|Baseline|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
10934195|NCT00729690|BG002|Baseline|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
10934196|NCT00729690|BG003|Baseline|Total|Total of all reporting groups
10934197|NCT00729690|FG000|Participant Flow|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
10934198|NCT00729690|FG001|Participant Flow|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
10934199|NCT00729690|FG002|Participant Flow|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
10934200|NCT00729690|OG000|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
10934201|NCT00729690|OG001|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
10934202|NCT00729690|OG002|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
10934203|NCT00729690|EG000|Reported Event|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
10934204|NCT00729690|EG001|Reported Event|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
11176134|NCT02034006|EG000|Reported Event|Ranibizumab|All subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment.
10934205|NCT00729690|EG002|Reported Event|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
10934206|NCT00729781|BG000|Baseline|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
10934207|NCT00729781|FG000|Participant Flow|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
10934208|NCT00729781|OG000|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
11176135|NCT02034019|BG000|Baseline|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone~Dexamethasone~Punctum Plug"
10934209|NCT00729781|EG000|Reported Event|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
10934210|NCT00729807|BG000|Baseline|Treatment Arm|Patients will receive 4 mg/kg/day IV pentamidine isethionate infused slowly over 2 hours on each treatment day. Each treatment cycle will consist of 2 weeks of therapy, five days per week, followed by 2 weeks of observation.
10934211|NCT00729807|FG000|Participant Flow|Treatment Arm|Pentamidine isethionate will be administered at a dose of 4 mg/kg/day over 120 minutes each day, Monday - Friday for two weeks followed by a drug free period of 2 weeks.
10934212|NCT00729807|OG000|Outcome|Pentamidine|Pentamidine isethionate will be administered at a dose of 4 mg/kg/day over 120 minutes each day, Monday - Friday for two weeks followed by a drug free period of 2 weeks.
10934213|NCT00729807|EG000|Reported Event|Treatment Arm|Pentamidine isethionate will be administered at a dose of 4 mg/kg/day over 120 minutes each day, Monday - Friday for two weeks followed by a drug free period of 2 weeks.
10934214|NCT00729833|BG000|Baseline|Figitumumab + Sunitinib (All Combined)|All participants who received at least one dose of figitumumab plus sunitinib.
10934215|NCT00729833|FG000|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab (CP-751,871) 10 milligram/kilogram (mg/kg) intravenous (IV) on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participant experienced a dose-limiting toxicity (DLT).
10934216|NCT00729833|FG001|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
10934217|NCT00729833|FG002|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
10934218|NCT00729833|FG003|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of continuous daily dosing followed by 1 week off, until disease progression or unacceptable toxicity.
10934219|NCT00729833|OG000|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
10934220|NCT00729833|OG001|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
10934221|NCT00729833|OG002|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
10934222|NCT00729833|OG003|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
10934223|NCT00729833|OG000|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
10934224|NCT00729833|EG000|Reported Event|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
10934225|NCT00729833|EG001|Reported Event|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
10934226|NCT00729833|EG002|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
10934227|NCT00729833|EG003|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
10934228|NCT00729846|BG000|Baseline|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
10934229|NCT00729846|BG001|Baseline|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
10934230|NCT00729846|BG002|Baseline|Total|Total of all reporting groups
10934231|NCT00729846|FG000|Participant Flow|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
10934232|NCT00729846|FG001|Participant Flow|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
10934233|NCT00729846|OG000|Outcome|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
11176136|NCT02034019|BG001|Baseline|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug~Punctum Plug"
10934234|NCT00729846|OG001|Outcome|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
10934235|NCT00729846|EG000|Reported Event|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
10934236|NCT00729846|EG001|Reported Event|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
10934237|NCT00729859|BG000|Baseline|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
10934238|NCT00729859|BG001|Baseline|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
10934239|NCT00729859|BG002|Baseline|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
10934240|NCT00729859|BG003|Baseline|Total|Total of all reporting groups
10934241|NCT00729859|FG000|Participant Flow|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
10934242|NCT00729859|FG001|Participant Flow|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
10934243|NCT00729859|FG002|Participant Flow|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
10934244|NCT00729859|OG000|Outcome|Group 1: Acyline + Placebo Gel + Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
10934245|NCT00729859|OG001|Outcome|Group 2: Acyline + T-gel 10g/Day + Placebo Pill|Acyline SQ inj. Day 0 & 14 + T-gel and placebo pill for 28 days
10934246|NCT00729859|OG002|Outcome|Group 3: Acyline + T-gel + Oral Anastrozole 1mg|Acyline SQ inj. Day 0 & 14 + T-gel and anastrozole for 28 days
10934247|NCT00729859|OG000|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
10934248|NCT00729859|OG001|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
10934249|NCT00729859|OG002|Outcome|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrazole pill 1 mg for 28 days
10934250|NCT00729859|OG002|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
10934251|NCT00729859|OG002|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
10934252|NCT00729859|OG002|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
10934253|NCT00729859|OG001|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
10934254|NCT00729859|OG002|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
11176137|NCT02034019|BG002|Baseline|Total|Total of all reporting groups
11176138|NCT02034019|FG000|Participant Flow|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone~Dexamethasone~Punctum Plug"
11176139|NCT02034019|FG001|Participant Flow|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug~Punctum Plug"
10934255|NCT00729859|EG000|Reported Event|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
10934256|NCT00729859|EG001|Reported Event|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
10934257|NCT00729859|EG002|Reported Event|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
10934258|NCT00729924|BG000|Baseline|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
10934259|NCT00729924|FG000|Participant Flow|Raltegravir 400mg Orally Every 12 Hours for 7 Days.|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
10934260|NCT00729924|OG000|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
10934261|NCT00729924|OG001|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
10934262|NCT00729924|OG000|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
10934263|NCT00729924|OG001|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
11176140|NCT02034019|OG000|Outcome|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone~Dexamethasone~Punctum Plug"
11176141|NCT02034019|OG001|Outcome|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug~Punctum Plug"
10934264|NCT00729924|EG000|Reported Event|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
10934265|NCT00729937|BG000|Baseline|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
10934266|NCT00729937|BG001|Baseline|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
10934267|NCT00729937|BG002|Baseline|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
10934268|NCT00729937|BG003|Baseline|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
10934269|NCT00729937|BG004|Baseline|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
10934270|NCT00729937|BG005|Baseline|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
10934271|NCT00729937|BG006|Baseline|Total|Total of all reporting groups
10934272|NCT00729937|FG000|Participant Flow|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
10934273|NCT00729937|FG001|Participant Flow|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
10934274|NCT00729937|FG002|Participant Flow|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
10934275|NCT00729937|FG003|Participant Flow|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
10934276|NCT00729937|FG004|Participant Flow|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
10934277|NCT00729937|FG005|Participant Flow|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
10934278|NCT00729937|OG000|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
10934279|NCT00729937|OG001|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
10934280|NCT00729937|OG002|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
10934281|NCT00729937|OG003|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
10934282|NCT00729937|OG004|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
10934283|NCT00729937|OG005|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
10934284|NCT00729937|EG000|Reported Event|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
10934285|NCT00729937|EG001|Reported Event|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
10934286|NCT00729937|EG002|Reported Event|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
10934287|NCT00729937|EG003|Reported Event|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
10934288|NCT00729937|EG004|Reported Event|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
10934289|NCT00729937|EG005|Reported Event|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
10934290|NCT00730015|BG000|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
10934291|NCT00730015|BG001|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
10934292|NCT00730015|BG002|Baseline|Placebo|Dose matched placebo, oral administration, once per day
10934293|NCT00730015|BG003|Baseline|Total|Total of all reporting groups
10934294|NCT00730015|FG000|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
10934295|NCT00730015|FG001|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
10934296|NCT00730015|FG002|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day
10934297|NCT00730015|OG000|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
10934298|NCT00730015|OG001|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
11176142|NCT02034019|EG000|Reported Event|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone~Dexamethasone~Punctum Plug"
11176143|NCT02034019|EG001|Reported Event|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug~Punctum Plug"
11176144|NCT02034058|BG000|Baseline|Stenting|Prospective, single-arm, consecutive enrollment, post market surveillance study of patients who have a Wingspan stent procedure attempted.
11176145|NCT02034058|FG000|Participant Flow|Stenting|Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
10934299|NCT00730015|OG002|Outcome|Placebo|Dose matched placebo, oral administration, once per day
10934300|NCT00730015|EG000|Reported Event|Linaclotide 145μg|Linaclotide, 145μg dose, oral administration, once per day
10934301|NCT00730015|EG001|Reported Event|Linaclotide 290μg|Linaclotide, 290μg dose, oral administration, once per day
10934302|NCT00730015|EG002|Reported Event|Placebo|Dose matched placebo, oral administration, once per day
10934303|NCT00730015|EG003|Reported Event|Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period|Dose-matched placebo, oral administration, once per day or Linaclotide 290μg, oral administration, once per day.
10934304|NCT00730015|EG004|Reported Event|Linaclotide 145μg to Placebo RW Period|Linaclotide 145μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
10934305|NCT00730015|EG005|Reported Event|Linaclotide 145μg to Linaclotide 145μg RW Period|Linaclotide 145μg, oral administration, once per day to Linaclotide 145μg, oral administration, once per day
10934306|NCT00730015|EG006|Reported Event|Linaclotide 290μg to Placebo RW Period|Linaclotide 290μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
11176146|NCT02034058|OG000|Outcome|Stenting|Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
10934307|NCT00730015|EG007|Reported Event|Linaclotide 290μg to Linaclotide 290μg RW Period|Linaclotide 290μg, oral administration, once per day to Linaclotide 290μg, oral administration, once per day
10934308|NCT00730028|BG000|Baseline|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
10934309|NCT00730028|BG001|Baseline|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
10934310|NCT00730028|BG002|Baseline|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
10934311|NCT00730028|BG003|Baseline|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
10934312|NCT00730028|BG004|Baseline|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
10934313|NCT00730028|BG005|Baseline|Total|Total of all reporting groups
10934314|NCT00730028|FG000|Participant Flow|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
10934315|NCT00730028|FG001|Participant Flow|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
11176147|NCT02034058|EG000|Reported Event|Stenting|Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
11176148|NCT02034162|BG000|Baseline|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
11176149|NCT02034162|BG001|Baseline|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
11176150|NCT02034162|BG002|Baseline|Total|Total of all reporting groups
11176151|NCT02034162|FG000|Participant Flow|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
11176152|NCT02034162|FG001|Participant Flow|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
11176153|NCT02034162|FG002|Participant Flow|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
10934316|NCT00730028|FG002|Participant Flow|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
10934317|NCT00730028|FG003|Participant Flow|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
10934318|NCT00730028|FG004|Participant Flow|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
10934319|NCT00730028|OG000|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
10934320|NCT00730028|OG001|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
10934321|NCT00730028|OG002|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
10934322|NCT00730028|OG003|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
10934323|NCT00730028|OG004|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
10934324|NCT00730028|EG000|Reported Event|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
10934325|NCT00730028|EG001|Reported Event|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
10934326|NCT00730028|EG002|Reported Event|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
10934327|NCT00730028|EG003|Reported Event|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
10934328|NCT00730028|EG004|Reported Event|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.
10934329|NCT00730041|BG000|Baseline|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
10934330|NCT00730041|BG001|Baseline|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
10934331|NCT00730041|BG002|Baseline|Total|Total of all reporting groups
10934332|NCT00730041|FG000|Participant Flow|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
10934333|NCT00730041|FG001|Participant Flow|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
10934334|NCT00730041|OG000|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
10934335|NCT00730041|OG001|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
10934336|NCT00730041|EG000|Reported Event|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
10934337|NCT00730041|EG001|Reported Event|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
10934338|NCT00730158|BG000|Baseline|Irinotecan+ KD018|"KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.~Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m²."
10934339|NCT00730158|BG001|Baseline|Irinotecan + Placebo|"Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².~Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks."
10934340|NCT00730158|BG002|Baseline|Total|Total of all reporting groups
10934341|NCT00730158|FG000|Participant Flow|Irinotecan+ KD018|"KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.~Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m²."
10934342|NCT00730158|FG001|Participant Flow|Irinotecan + Placebo|"Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².~Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks."
10934343|NCT00730158|OG000|Outcome|Arm A - Irinotecan + KD018|"KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.~Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m²."
10934344|NCT00730158|OG001|Outcome|Arm B - Irinotecan + Placebo|"Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².~Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks."
10934345|NCT00730158|OG000|Outcome|Arm A - Irinotecan + KD018|"Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.~Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m²."
10934346|NCT00730158|OG001|Outcome|Arm B - Irinotecan + Placebo|"Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m²..~Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks."
10934347|NCT00730158|OG001|Outcome|Arm B - Irinotecan + Placebo|"Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².~Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks."
10934348|NCT00730158|OG000|Outcome|Arm A - Irinotecan+ KD018|"KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.~Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m²."
10934349|NCT00730158|EG000|Reported Event|Arm A - Irinotecan + KD018|"KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.~Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m²."
10934350|NCT00730158|EG001|Reported Event|Arm B - Irinotecan + Placebo|"Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².~Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks."
10934351|NCT00730171|BG000|Baseline|Overall Safety Population|All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
11176154|NCT02034162|OG000|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
11176155|NCT02034162|OG001|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
11176156|NCT02034162|OG000|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
11176157|NCT02034162|OG001|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
11176158|NCT02034162|OG002|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
11176159|NCT02034162|OG000|Outcome|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
10934352|NCT00730171|FG000|Participant Flow|Overal Safey Population: Total|All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
10934353|NCT00730171|OG000|Outcome|CC Safety Population: Total|RI and RO participants who met the Rome II criteria for CC and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
10934354|NCT00730171|OG001|Outcome|IBS-C Safety Population: Total|RI and RO participants who met the Rome II criteria for IBS-C and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
10934355|NCT00730171|OG002|Outcome|Overall Safety Population: Total|All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
10934356|NCT00730171|EG000|Reported Event|CC Safety Population: Total|RI and RO participants who met the modified Rome II criteria for CC and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
10934357|NCT00730171|EG001|Reported Event|IBS-C Safety Population: Total|RI and RO participants who met the modified Rome II criteria for IBS-C and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
10934358|NCT00730171|EG002|Reported Event|Overall Safety Population: Total|All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
10934359|NCT00730236|BG000|Baseline|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
10934360|NCT00730236|FG000|Participant Flow|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
11176160|NCT02034162|EG000|Reported Event|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
10934361|NCT00730236|OG000|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
10934362|NCT00730236|EG000|Reported Event|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
10934363|NCT00730275|BG000|Baseline|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
10934364|NCT00730275|BG001|Baseline|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
11176161|NCT02034162|EG001|Reported Event|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
10934365|NCT00730275|BG002|Baseline|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
10934366|NCT00730275|BG003|Baseline|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
10934367|NCT00730275|BG004|Baseline|Total|Total of all reporting groups
10934368|NCT00730275|FG000|Participant Flow|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
10934369|NCT00730275|FG001|Participant Flow|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
10934370|NCT00730275|FG002|Participant Flow|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
10934371|NCT00730275|FG003|Participant Flow|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
10934372|NCT00730275|OG000|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
10934373|NCT00730275|OG001|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
10934374|NCT00730275|OG002|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
10934375|NCT00730275|OG003|Outcome|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
10934376|NCT00730275|OG003|Outcome|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
10934377|NCT00730275|EG000|Reported Event|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
10934378|NCT00730275|EG001|Reported Event|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
10934379|NCT00730275|EG002|Reported Event|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
10934380|NCT00730275|EG003|Reported Event|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
11176162|NCT02034162|EG002|Reported Event|OL Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
11176163|NCT02034175|BG000|Baseline|SomnaPatch and PSG Simultaneously|All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
10934381|NCT00730327|BG000|Baseline|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
10934382|NCT00730327|BG001|Baseline|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
10934383|NCT00730327|BG002|Baseline|Total|Total of all reporting groups
10934384|NCT00730327|FG000|Participant Flow|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
10934385|NCT00730327|FG001|Participant Flow|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
10934386|NCT00730327|OG000|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
10934387|NCT00730327|OG001|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
10934388|NCT00730327|EG000|Reported Event|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
10934389|NCT00730327|EG001|Reported Event|Control|Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
10934390|NCT00730353|BG000|Baseline|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
10934391|NCT00730353|FG000|Participant Flow|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
10934392|NCT00730353|OG000|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
10934393|NCT00730353|EG000|Reported Event|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
10934394|NCT00730405|BG000|Baseline|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934395|NCT00730405|BG001|Baseline|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934396|NCT00730405|BG002|Baseline|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10964072|NCT00875667|FG000|Participant Flow|Lenalidomide|Participants received lenalidomide 25 mg capsules orally every day for 21 days of each 28-day treatment cycle until disease progression or unacceptable toxicity. Participants with moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but < 60mL/min received 10 mg lenalidomide for 21 days of each 28-day cycle (Cycles 1 and 2). After Cycle 2, if the participant remained free of Grade 3 or Grade 4 toxicity, the dose was increased to 15 mg lenalidomide for 21 days of each 28-day treatment cycle until disease progression or unacceptable toxicity.
10934397|NCT00730405|BG003|Baseline|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934398|NCT00730405|BG004|Baseline|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934399|NCT00730405|BG005|Baseline|Total|Total of all reporting groups
10934400|NCT00730405|FG000|Participant Flow|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 milligrams (mg) of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934401|NCT00730405|FG001|Participant Flow|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934402|NCT00730405|FG002|Participant Flow|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934403|NCT00730405|FG003|Participant Flow|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934404|NCT00730405|FG004|Participant Flow|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934405|NCT00730405|OG000|Outcome|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934406|NCT00730405|OG001|Outcome|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934407|NCT00730405|OG002|Outcome|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934408|NCT00730405|OG003|Outcome|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
11176164|NCT02034175|FG000|Participant Flow|SomnaPatch and PSG Simultaneously|All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
11176165|NCT02034175|OG000|Outcome|SomnaPatch and PSG Simultaneously|All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
10934409|NCT00730405|OG004|Outcome|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934410|NCT00730405|OG000|Outcome|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934411|NCT00730405|OG001|Outcome|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934412|NCT00730405|EG000|Reported Event|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934413|NCT00730405|EG001|Reported Event|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934414|NCT00730405|EG002|Reported Event|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934415|NCT00730405|EG003|Reported Event|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934416|NCT00730405|EG004|Reported Event|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
10934417|NCT00730483|BG000|Baseline|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
10934418|NCT00730483|FG000|Participant Flow|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
10934419|NCT00730483|OG000|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
10934420|NCT00730483|OG000|Outcome|Single Arm|PVA microporous hydrospheres/doxorubicin hydrochloride
10934421|NCT00730483|EG000|Reported Event|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
10934422|NCT00730522|BG000|Baseline|Vigabatrin|"CPP-109 vigabatrin tablets~CPP-109 vigabatrin: tablets, bid for 12 weeks"
10934423|NCT00730522|BG001|Baseline|Matching Placebo|"Matching Placebo Tablets~Matching Placebo: tablets, bid, 12 weeks"
10934424|NCT00730522|BG002|Baseline|Total|Total of all reporting groups
10934425|NCT00730522|FG000|Participant Flow|Vigabatrin Tablets|"CPP-109 vigabatrin tablets (3.0 gm/day) for 12 weeks including 2 week dose escalation~CPP-109 vigabatrin: tablets, bid for 12 weeks"
10934426|NCT00730522|FG001|Participant Flow|Matching Placebo Tablets|"Matching Placebo Tablets for 12 weeks on a schedule to match active arm~Matching Placebo: tablets, bid"
10934427|NCT00730522|OG000|Outcome|Vigabatrin|"CPP-109 vigabatrin tablets~CPP-109 vigabatrin: tablets, bid for 12 weeks"
10934428|NCT00730522|OG001|Outcome|Placebo|"Matching Placebo Tablets~Matching Placebo: tablets, bid, 12 weeks"
10934429|NCT00730522|OG000|Outcome|CPP-109 Vigabatrin Treated Group|"Participants who received CPP-109 (vigabatrin) tablets~CPP-109 vigabatrin: tablets, bid for 12 weeks"
10934430|NCT00730522|OG001|Outcome|Matching Placebo Treated Group|"Participants who received Matching Placebo Tablets~Matching Placebo: tablets, bid, 12 weeks"
10934431|NCT00730522|EG000|Reported Event|Vigabatrin|"CPP-109 vigabatrin tablets~CPP-109 vigabatrin: tablets, bid for 12 weeks"
10934432|NCT00730522|EG001|Reported Event|Placebo|"Matching Placebo Tablets~Matching Placebo: tablets, bid, 12 weeks"
10934433|NCT00730691|BG000|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
10934434|NCT00730691|BG001|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
10934435|NCT00730691|BG002|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
10934436|NCT00730691|BG003|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
10934437|NCT00730691|BG004|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
10934438|NCT00730691|BG005|Baseline|Total|Total of all reporting groups
10934439|NCT00730691|FG000|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
11176166|NCT02034175|EG000|Reported Event|SomnaPatch and PSG Simultaneously|All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
10934440|NCT00730691|FG001|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
10934441|NCT00730691|FG002|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
10934442|NCT00730691|FG003|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
10934443|NCT00730691|FG004|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
10934444|NCT00730691|OG000|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
10934445|NCT00730691|OG001|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
10934446|NCT00730691|OG002|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
10934447|NCT00730691|OG003|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
10934448|NCT00730691|OG004|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
10934449|NCT00730691|EG000|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
10934450|NCT00730691|EG001|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
10934451|NCT00730691|EG002|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
10934452|NCT00730691|EG003|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
10934453|NCT00730691|EG004|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
10934454|NCT00730730|BG000|Baseline|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
10934455|NCT00730730|FG000|Participant Flow|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
10934456|NCT00730730|OG000|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
10934457|NCT00730730|EG000|Reported Event|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
10934458|NCT00730756|BG000|Baseline|Placebo|Vehicle placebo nasal spray once daily
10934459|NCT00730756|BG001|Baseline|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
10934460|NCT00730756|BG002|Baseline|Total|Total of all reporting groups
10934461|NCT00730756|FG000|Participant Flow|Placebo|Vehicle placebo nasal spray once daily
10934462|NCT00730756|FG001|Participant Flow|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
10934463|NCT00730756|OG000|Outcome|Placebo|Vehicle placebo nasal spray once daily
11176167|NCT02034409|BG000|Baseline|Sham|"Treatment to index knee with sham device for 48 weeks~Sham Comparator: 20 minutes daily for 48 weeks"
11176168|NCT02034409|BG001|Baseline|PLIUS|"Treatment to index knee with PLIUS device for 48 weeks~Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks"
11176169|NCT02034409|BG002|Baseline|Total|Total of all reporting groups
11176170|NCT02034409|FG000|Participant Flow|Sham|"Treatment to index knee with sham device for 48 weeks~ShamComparator: 20 minutes daily for 48 weeks"
10934464|NCT00730756|OG001|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
10934465|NCT00730756|EG000|Reported Event|Placebo|Vehicle placebo nasal spray once daily
10934466|NCT00730756|EG001|Reported Event|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
10934467|NCT00730847|BG000|Baseline|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
10934468|NCT00730847|FG000|Participant Flow|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
10934469|NCT00730847|OG000|Outcome|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
10934470|NCT00730847|EG000|Reported Event|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
10934471|NCT00730912|BG000|Baseline|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
10934472|NCT00730912|BG001|Baseline|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
10934473|NCT00730912|BG002|Baseline|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
10934474|NCT00730912|BG003|Baseline|Total|Total of all reporting groups
10934475|NCT00730912|FG000|Participant Flow|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
11176171|NCT02034409|FG001|Participant Flow|PLIUS (Pulsed Low Intensity UltraSound)|"Treatment to index knee with PLIUS device for 48 weeks~PLIUS device: 20 minutes daily for 48 weeks"
10934476|NCT00730912|FG001|Participant Flow|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
10934477|NCT00730912|FG002|Participant Flow|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
10934478|NCT00730912|OG000|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
10934479|NCT00730912|OG001|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
10934480|NCT00730912|OG002|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
10934481|NCT00730912|EG000|Reported Event|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
10934482|NCT00730912|EG001|Reported Event|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
10934483|NCT00730912|EG002|Reported Event|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
10934484|NCT00730925|BG000|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
10934485|NCT00730925|FG000|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
10934486|NCT00730925|OG000|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
10934487|NCT00730925|EG000|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
11176172|NCT02034409|OG000|Outcome|Sham|"Treatment to index knee with sham device for 48 weeks~Sham Comparator: 20 minutes daily for 48 weeks"
11176173|NCT02034409|OG001|Outcome|PLIUS|"Treatment to index knee with PLIUS device for 48 weeks~Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks"
10934488|NCT00730964|BG000|Baseline|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
10934489|NCT00730964|FG000|Participant Flow|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
10934490|NCT00730964|OG000|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product.
10934491|NCT00730964|OG000|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
10934492|NCT00730964|EG000|Reported Event|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
10934493|NCT00731042|BG000|Baseline|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
10934494|NCT00731042|BG001|Baseline|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
10934495|NCT00731042|BG002|Baseline|Total|Total of all reporting groups
10934496|NCT00731042|FG000|Participant Flow|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
10934497|NCT00731042|FG001|Participant Flow|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
10934498|NCT00731042|OG000|Outcome|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
10934499|NCT00731042|OG001|Outcome|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
10934500|NCT00731042|EG000|Reported Event|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
10934501|NCT00731042|EG001|Reported Event|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
10934502|NCT00731055|BG000|Baseline|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
11176174|NCT02034409|EG000|Reported Event|Sham|"Treatment to index knee with sham device for 48 weeks~Sham Comparator: 20 minutes daily for 48 weeks"
10934503|NCT00731055|FG000|Participant Flow|Study Participants|This is a within-group study design, all participant who completed the study receive all 4 experimental treatments
10934504|NCT00731055|OG000|Outcome|Placebo|The outcome of the session during which participant received placebo
10934505|NCT00731055|OG001|Outcome|Varenicline 0.5 mg|The outcome of the session during which participant received varenicline 0.5 mg
10934506|NCT00731055|OG002|Outcome|Varenicline 1.0 mg|The outcome of the session during which participant received varenicline 1.0 mg
10934507|NCT00731055|OG003|Outcome|Varenicline 2.0 mg|The outcome of the session during which participant received varenicline 2.0 mg
10934508|NCT00731055|EG000|Reported Event|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
10934509|NCT00731094|BG000|Baseline|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
10934510|NCT00731094|BG001|Baseline|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
10934511|NCT00731094|BG002|Baseline|Total|Total of all reporting groups
10934512|NCT00731094|FG000|Participant Flow|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
10934513|NCT00731094|FG001|Participant Flow|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
10934514|NCT00731094|OG000|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
10934515|NCT00731094|OG001|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
10934516|NCT00731094|EG000|Reported Event|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
10934517|NCT00731094|EG001|Reported Event|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
10934518|NCT00731120|BG000|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10934519|NCT00731120|BG001|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
10934520|NCT00731120|BG002|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
10934521|NCT00731120|BG003|Baseline|Total|Total of all reporting groups
10934522|NCT00731120|FG000|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10934523|NCT00731120|FG001|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
10934524|NCT00731120|FG002|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
10934525|NCT00731120|OG000|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10934526|NCT00731120|OG001|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
10934527|NCT00731120|OG002|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
10934528|NCT00731120|EG000|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10934529|NCT00731120|EG001|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
10934530|NCT00731120|EG002|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
10934531|NCT00731133|BG000|Baseline|Disulfiram|Disulfiram at 250 mg daily
10934532|NCT00731133|FG000|Participant Flow|Disulfiram|Disulfiram at 250 mg daily
10934533|NCT00731133|OG000|Outcome|Disulfiram 250 mg|
11176175|NCT02034409|EG001|Reported Event|PLIUS|"Treatment to index knee with PLIUS device for 48 weeks~Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks"
11176176|NCT02034435|BG000|Baseline|Aim 1|Low Sodium and High Sodium diet crossover
10934534|NCT00731133|EG000|Reported Event|Disulfiram|Disulfiram at 250 mg daily
10934535|NCT00731198|BG000|Baseline|Experimental|Drotaverine hydrochloride
10934536|NCT00731198|BG001|Baseline|Active Comparator|Hyoscine-N-butylbromide
10934537|NCT00731198|BG002|Baseline|Total|Total of all reporting groups
10934538|NCT00731198|FG000|Participant Flow|Experimental|Drotaverine hydrochloride
10934539|NCT00731198|FG001|Participant Flow|Active Comparator|Hyoscine-N-butylbromide
11176177|NCT02034435|BG001|Baseline|Aim 2|Eplerenone and Amlodipine crossover
11176178|NCT02034435|BG002|Baseline|Total|Total of all reporting groups
10934540|NCT00731198|OG000|Outcome|Experimental|Drotaverine hydrochloride
10934541|NCT00731198|OG001|Outcome|Active Comparator|Hyoscine-N-butylbromide
10934542|NCT00731198|EG000|Reported Event|Experimental|Drotaverine hydrochloride
10934543|NCT00731198|EG001|Reported Event|Active Comparator|Hyoscine-N-butylbromide
10934544|NCT00731211|BG000|Baseline|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
10934545|NCT00731211|FG000|Participant Flow|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
10934546|NCT00731211|OG000|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
11176179|NCT02034435|FG000|Participant Flow|Aim1-Low Sodium Then High Sodium|"Subjects will be provided with a low sodium diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.~Participants will be given low sodium diet (50mEq/d) and Placebo tablets for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Salt tables (150mEq) for 8days and assessments will be made.~Low Salt diet plus Placebo tablet~Low Sodium diet plus Salt tablet"
11176180|NCT02034435|FG001|Participant Flow|Aim 1-High Sodium Then Low Sodium|"Subjects will be provided with a diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.~Participants will be given low sodium diet (50mEq/d) and Salt tables (150mEq) for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Placebo tablets for 8days and assessments will be made.~Low Salt diet plus Placebo tablet~Low Sodium diet plus Salt tablet"
11176181|NCT02034435|FG002|Participant Flow|Aim2- Low Sodium Diet and Epleronone Then Amlodipine|"Subjects on a low salt diet will receive Epleronone 50mg for 8 days and assessments will be made, then cross over to a low salt diet with Amlodipine 5mg for 8days and assessments will be made.~Low Salt diet plus Placebo tablet~Epleronone: 50mg daily~Amlodipine: 5mg daily"
11176182|NCT02034435|FG003|Participant Flow|Aim2- Low Sodium Diet and Amlodipine Then Epleronone|"Subjects on a low salt diet will receive Amlodipine 5mg for 8 days and assessments will be made, then cross over to a low salt diet with Epleronone 50mg for 8days and assessments will be made.~Low Salt diet plus Placebo tablet~Epleronone: 50mg daily~Amlodipine: 5mg daily"
11176183|NCT02034435|OG000|Outcome|Aim 1- Low Sodium|Low Sodium diet (50mEq/d)
11176184|NCT02034435|OG001|Outcome|Aim 1- High Sodium|Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d)
11176185|NCT02034435|OG002|Outcome|Aim 2- Eplerenone|Low sodium diet (50mEq/d) plus Eplerenone
10934547|NCT00731211|EG000|Reported Event|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
10934548|NCT00731341|BG000|Baseline|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
10934549|NCT00731341|FG000|Participant Flow|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
11176186|NCT02034435|OG003|Outcome|Aim 2- Amlodipine|Low sodium diet (50mEq/d) plus Amlodipine
11176187|NCT02034435|EG000|Reported Event|Aim 1- Low Sodium|Low Sodium diet (50mEq/d)
11176188|NCT02034435|EG001|Reported Event|Aim 1- High Sodium|Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d)
11176189|NCT02034435|EG002|Reported Event|Aim 2- Eplerenone|Low sodium diet (50mEq/d) plus Eplerenone
11176190|NCT02034435|EG003|Reported Event|Aim 2- Amlodipine|Low sodium diet (50mEq/d) plus Amlodipine
10934550|NCT00731341|OG000|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
10934551|NCT00731341|EG000|Reported Event|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
10934552|NCT00731484|BG000|Baseline|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
10934553|NCT00731484|FG000|Participant Flow|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
10934554|NCT00731484|OG000|Outcome|General Population|Subjects were recruited from patients presenting for a routine visit at the physician office study sites
11176191|NCT02034474|BG000|Baseline|Placebo|Placebo-receiving group
11176192|NCT02034474|BG001|Baseline|Tocilizumab|Tocilizumab-receiving group
11176193|NCT02034474|BG002|Baseline|Total|Total of all reporting groups
11176194|NCT02034474|FG000|Participant Flow|Tocilizumab|Tocilizumab (N=19)
11176195|NCT02034474|FG001|Participant Flow|Placebo|Placebo (N=17)
11176196|NCT02034474|OG000|Outcome|Placebo|Patients on placebo
11176197|NCT02034474|OG001|Outcome|Tocilizumab|Patients on Tocilizumab
11176198|NCT02034474|OG000|Outcome|Tocilizumab|"Tocilizumab will be administered at day 0, week 4 and week 8 via an iv drip over 60 min. Dose is 8mg/kg but may be reduced to 4mg/kg if intolerable. Maximum dose will be 800mg.~Tocilizumab: 8mg/kg intravenously via iv drip over 60 min"
10934555|NCT00731484|EG000|Reported Event|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
10934556|NCT00731549|BG000|Baseline|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
10934557|NCT00731549|FG000|Participant Flow|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
10934558|NCT00731549|OG000|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
10934559|NCT00731549|EG000|Reported Event|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
10934560|NCT00731588|BG000|Baseline|PPG1A - Adults|"Phase I completed: Healthy male and post-menopausal female volunteers between the ages of 18 and 65. Volunteers must not have donated blood in the previous 8 weeks.~Transfused Biotin RBCs - Adults Phase I: A 3 mL venous blood sample is obtained. 250 mL of blood will be drawn to a blood collection bag containing the anticoagulant CPD. Separate equal volumes of RBCs are labeled with up to five different densities of biotin. The biotinylated RBCs are resuspended in autologous plasma to achieve a 60 to 70% hematocrit. An IV is inserted for the reinfusion of the biotinylated RBCs. Three mL aliquots of blood are sampled at 5, 10, 20, and 60 minutes after infusion. The subject returns ~24 hours and 3 days after the RBC infusion to obtain a 3 mL venous blood sample. Subjects return for weekly 3 mL blood sampling."
10934561|NCT00731588|BG001|Baseline|PPG1B - Infants|"Phase II in progress: Newborns >= 24 weeks gestation who are patients in the Neonatal Intensive Care Unit at the University of Iowa Hospitals and Clinics that are being treated with the expectation of survival.~Transfused Biotin RBCs - Infants Phase II: After the infant's clinical care team decides that a RBC transfusion is needed, a 15mL/kilogram of body weight is ordered. Transfusion will be given in 2 parts: 1) approximately 80% of the total transfusion to be transfused over 3-4 hours and 2) approximately 20% of the total transfusion will be marked with biotin to be transfused upon completion of the first part. The bedside nurse maintains constant observation of the infant as appropriate for the infant's condition, assessing for signs and symptoms of a transfusion reaction.~Transfused Biotin RBCs - Infants Phase III: Phase III (infants) to be determined upon completion of Phase II (infants)."
10934562|NCT00731588|BG002|Baseline|Total|Total of all reporting groups
10934563|NCT00731588|FG000|Participant Flow|PPG1A - Adults|"Phase I completed: Healthy male and post-menopausal female volunteers between the ages of 18 and 65. Volunteers must not have donated blood in the previous 8 weeks.~Transfused Biotin RBCs - Adults Phase I: A 3 mL venous blood sample is obtained. 250 mL of blood will be drawn to a blood collection bag containing the anticoagulant CPD. Separate equal volumes of RBCs are labeled with up to five different densities of biotin. The biotinylated RBCs are resuspended in autologous plasma to achieve a 60 to 70% hematocrit. An IV is inserted for the reinfusion of the biotinylated RBCs. Three mL aliquots of blood are sampled at 5, 10, 20, and 60 minutes after infusion. The subject returns ~24 hours and 3 days after the RBC infusion to obtain a 3 mL venous blood sample. Subjects return for weekly 3 mL blood sampling."
10934564|NCT00731588|FG001|Participant Flow|PPG1B - Infants|"Phase II in progress: Newborns >= 24 weeks gestation who are patients in the Neonatal Intensive Care Unit at the University of Iowa Hospitals and Clinics that are being treated with the expectation of survival.~Transfused Biotin RBCs - Infants Phase II: After the infant's clinical care team decides that a RBC transfusion is needed, a 15mL/kilogram of body weight is ordered. Transfusion will be given in 2 parts: 1) approximately 80% of the total transfusion to be transfused over 3-4 hours and 2) approximately 20% of the total transfusion will be marked with biotin to be transfused upon completion of the first part. The bedside nurse maintains constant observation of the infant as appropriate for the infant's condition, assessing for signs and symptoms of a transfusion reaction.~Transfused Biotin RBCs - Infants Phase III: Phase III (infants) to be determined upon completion of Phase II (infants)."
10934565|NCT00731588|OG000|Outcome|PPG1A - Adults|"Phase I completed: Healthy male and post-menopausal female volunteers between the ages of 18 and 65. Volunteers must not have donated blood in the previous 8 weeks.~Transfused Biotin RBCs - Adults Phase I: A 3 mL venous blood sample is obtained. 250 mL of blood will be drawn to a blood collection bag containing the anticoagulant CPD. Separate equal volumes of RBCs are labeled with up to five different densities of biotin. The biotinylated RBCs are resuspended in autologous plasma to achieve a 60 to 70% hematocrit. An IV is inserted for the reinfusion of the biotinylated RBCs. Three mL aliquots of blood are sampled at 5, 10, 20, and 60 minutes after infusion. The subject returns ~24 hours and 3 days after the RBC infusion to obtain a 3 mL venous blood sample. Subjects return for weekly 3 mL blood sampling."
10934566|NCT00731588|OG001|Outcome|PPG1B - Infants|"Phase II in progress: Newborns >= 24 weeks gestation who are patients in the Neonatal Intensive Care Unit at the University of Iowa Hospitals and Clinics that are being treated with the expectation of survival.~Transfused Biotin RBCs - Infants Phase II: After the infant's clinical care team decides that a RBC transfusion is needed, a 15mL/kilogram of body weight is ordered. Transfusion will be given in 2 parts: 1) approximately 80% of the total transfusion to be transfused over 3-4 hours and 2) approximately 20% of the total transfusion will be marked with biotin to be transfused upon completion of the first part. The bedside nurse maintains constant observation of the infant as appropriate for the infant's condition, assessing for signs and symptoms of a transfusion reaction.~Transfused Biotin RBCs - Infants Phase III: Phase III (infants) to be determined upon completion of Phase II (infants)."
11176199|NCT02034474|OG001|Outcome|Placebo|"Placebo will be administered intravenously via an iv drip over 60 min~Placebo: intravenously via iv drip over 60 min"
11176200|NCT02034474|EG000|Reported Event|Placebo|Subjects who received placebo
11176201|NCT02034474|EG001|Reported Event|Tocilizumab|Subjects who received tocilizumab
10934567|NCT00731588|OG000|Outcome|PPG1B - Infants|"Phase II in progress: Newborns >= 24 weeks gestation who are patients in the Neonatal Intensive Care Unit at the University of Iowa Hospitals and Clinics that are being treated with the expectation of survival.~Transfused Biotin RBCs - Infants Phase II: After the infant's clinical care team decides that a RBC transfusion is needed, a 15mL/kilogram of body weight is ordered. Transfusion will be given in 2 parts: 1) approximately 80% of the total transfusion to be transfused over 3-4 hours and 2) approximately 20% of the total transfusion will be marked with biotin to be transfused upon completion of the first part. The bedside nurse maintains constant observation of the infant as appropriate for the infant's condition, assessing for signs and symptoms of a transfusion reaction.~Transfused Biotin RBCs - Infants Phase III: Phase III (infants) to be determined upon completion of Phase II (infants)."
10934568|NCT00731588|EG000|Reported Event|PPG1A - Adults|"Phase I completed: Healthy male and post-menopausal female volunteers between the ages of 18 and 65. Volunteers must not have donated blood in the previous 8 weeks.~Transfused Biotin RBCs - Adults Phase I: A 3 mL venous blood sample is obtained. 250 mL of blood will be drawn to a blood collection bag containing the anticoagulant CPD. Separate equal volumes of RBCs are labeled with up to five different densities of biotin. The biotinylated RBCs are resuspended in autologous plasma to achieve a 60 to 70% hematocrit. An IV is inserted for the reinfusion of the biotinylated RBCs. Three mL aliquots of blood are sampled at 5, 10, 20, and 60 minutes after infusion. The subject returns ~24 hours and 3 days after the RBC infusion to obtain a 3 mL venous blood sample. Subjects return for weekly 3 mL blood sampling."
10934569|NCT00731588|EG001|Reported Event|PPG1B - Infants|"Phase II in progress: Newborns >= 24 weeks gestation who are patients in the Neonatal Intensive Care Unit at the University of Iowa Hospitals and Clinics that are being treated with the expectation of survival.~Transfused Biotin RBCs - Infants Phase II: After the infant's clinical care team decides that a RBC transfusion is needed, a 15mL/kilogram of body weight is ordered. Transfusion will be given in 2 parts: 1) approximately 80% of the total transfusion to be transfused over 3-4 hours and 2) approximately 20% of the total transfusion will be marked with biotin to be transfused upon completion of the first part. The bedside nurse maintains constant observation of the infant as appropriate for the infant's condition, assessing for signs and symptoms of a transfusion reaction.~Transfused Biotin RBCs - Infants Phase III: Phase III (infants) to be determined upon completion of Phase II (infants)."
10934570|NCT00731614|BG000|Baseline|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
10934571|NCT00731614|BG001|Baseline|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
10934572|NCT00731614|BG002|Baseline|Total|Total of all reporting groups
10934573|NCT00731614|FG000|Participant Flow|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
11176202|NCT02034513|BG000|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
10934574|NCT00731614|FG001|Participant Flow|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
10934575|NCT00731614|OG000|Outcome|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
10934576|NCT00731614|OG001|Outcome|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
10934577|NCT00731614|EG000|Reported Event|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
10934578|NCT00731614|EG001|Reported Event|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
10934579|NCT00731640|BG000|Baseline|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
10934580|NCT00731640|BG001|Baseline|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
10934581|NCT00731640|BG002|Baseline|Total|Total of all reporting groups
10934582|NCT00731640|FG000|Participant Flow|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
10934583|NCT00731640|FG001|Participant Flow|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
10934584|NCT00731640|OG000|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
10934585|NCT00731640|OG001|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
10934586|NCT00731640|EG000|Reported Event|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
11176203|NCT02034513|BG001|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
11176204|NCT02034513|BG002|Baseline|Total|Total of all reporting groups
10934587|NCT00731640|EG001|Reported Event|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
10934588|NCT00731653|BG000|Baseline|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
10934589|NCT00731653|FG000|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
10934590|NCT00731653|OG000|Outcome|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
10934591|NCT00731653|EG000|Reported Event|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
10934592|NCT00731666|BG000|Baseline|Titan® IPP|Subjects implanted with Titan® IPP
10934593|NCT00731666|FG000|Participant Flow|Titan® IPP|Subjects implanted with Titan® IPP
10934594|NCT00731666|OG000|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
10934595|NCT00731666|EG000|Reported Event|Titan® IPP|Subjects implanted with Titan® IPP
10934596|NCT00731679|BG000|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10934597|NCT00731679|BG001|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10934598|NCT00731679|BG002|Baseline|Total|Total of all reporting groups
10934599|NCT00731679|FG000|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10934600|NCT00731679|FG001|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10934601|NCT00731679|OG000|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10934602|NCT00731679|OG001|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10934603|NCT00731679|EG000|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10934604|NCT00731679|EG001|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
10934605|NCT00731692|BG000|Baseline|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
10934606|NCT00731692|BG001|Baseline|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
10934607|NCT00731692|BG002|Baseline|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
10934608|NCT00731692|BG003|Baseline|Total|Total of all reporting groups
10934609|NCT00731692|FG000|Participant Flow|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
10934610|NCT00731692|FG001|Participant Flow|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
10934611|NCT00731692|FG002|Participant Flow|Placebo to -FTY 0.5 mg|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
10934612|NCT00731692|OG000|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
10934613|NCT00731692|OG001|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
10934614|NCT00731692|OG000|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
10934615|NCT00731692|OG001|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
10934616|NCT00731692|OG002|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
10934617|NCT00731692|OG001|Outcome|FTY720 1.25mg to 0.5 mg|fingolimod 1.25mg/0.5 mg group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg
10934618|NCT00731692|OG002|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
10934619|NCT00731692|OG000|Outcome|FTY720 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
11176205|NCT02034513|FG000|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered subcutaneously (s.c.; under the skin) in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken once daily (OD) at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast self measured plasma glucose(SMPG) values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L)
11176206|NCT02034513|FG001|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
11176207|NCT02034513|OG000|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
11176208|NCT02034513|OG001|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
10934620|NCT00731692|EG000|Reported Event|Core: FTY720 1.25 mg|Patients who received FTY720 1.25 mg during core
10934621|NCT00731692|EG001|Reported Event|Core: FTY720 0.5 mg|Patients who received FTY720 0.5 mg during core
10934622|NCT00731692|EG002|Reported Event|Core: Placebo|Patients who received Placebo during core
10934623|NCT00731692|EG003|Reported Event|Extension: FTY1.25-0.5|Patients who received FTY20 1.25 mg in core and received 0.5 mg of FTY during Extension
10934624|NCT00731692|EG004|Reported Event|Extension: FTY0.5-0.5|Patients who received FTY20 0.5 mg in core and received 0.5 mg of FTY during Extension
10934625|NCT00731692|EG005|Reported Event|Extension: Placebo-FTY0.5|Patients who received Placebo in core and received 0.5 mg of FTY during Extension
10934626|NCT00731783|BG000|Baseline|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
10934627|NCT00731783|BG001|Baseline|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
10934628|NCT00731783|BG002|Baseline|Total|Total of all reporting groups
10934629|NCT00731783|FG000|Participant Flow|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
10934630|NCT00731783|FG001|Participant Flow|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
10934631|NCT00731783|OG000|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
10934632|NCT00731783|OG001|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
10934633|NCT00731783|EG000|Reported Event|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
10934634|NCT00731783|EG001|Reported Event|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
10934635|NCT00731822|BG000|Baseline|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
10934636|NCT00731822|BG001|Baseline|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
10934637|NCT00731822|BG002|Baseline|Total|Total of all reporting groups
10934638|NCT00731822|FG000|Participant Flow|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
10934639|NCT00731822|FG001|Participant Flow|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
10934640|NCT00731822|OG000|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
10934641|NCT00731822|OG001|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
10934642|NCT00731822|EG000|Reported Event|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
10934643|NCT00731822|EG001|Reported Event|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
10934644|NCT00731874|BG000|Baseline|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
10934645|NCT00731874|BG001|Baseline|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
10934646|NCT00731874|BG002|Baseline|Total|Total of all reporting groups
10934647|NCT00731874|FG000|Participant Flow|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
10934648|NCT00731874|FG001|Participant Flow|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
10934649|NCT00731874|OG000|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
10934650|NCT00731874|OG001|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
11176209|NCT02034513|OG000|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
10934651|NCT00731874|EG000|Reported Event|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
10934652|NCT00731874|EG001|Reported Event|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
10934653|NCT00731939|BG000|Baseline|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
10934654|NCT00731939|FG000|Participant Flow|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
10934655|NCT00731939|OG000|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
10934656|NCT00731939|EG000|Reported Event|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
10934657|NCT00732030|BG000|Baseline|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
10934658|NCT00732030|FG000|Participant Flow|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
10934659|NCT00732030|OG000|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
10934660|NCT00732030|EG000|Reported Event|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
10934661|NCT00732069|BG000|Baseline|All Study Participants|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
10934662|NCT00732069|FG000|Participant Flow|Placebo, Then Ramipril, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
10934663|NCT00732069|FG001|Participant Flow|Placebo, Valsartan, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
10934664|NCT00732069|FG002|Participant Flow|Ramipril, Then Placebo, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
10934665|NCT00732069|FG003|Participant Flow|Valsartan, Then Placebo, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
10934666|NCT00732069|FG004|Participant Flow|Ramipril, Valsartan, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
10934667|NCT00732069|FG005|Participant Flow|Valsartan, Ramipril, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
10934668|NCT00732069|OG000|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
10934669|NCT00732069|OG001|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
10934670|NCT00732069|OG002|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
10934671|NCT00732069|EG000|Reported Event|Ramipril|All subjects receiving ramipril
10934672|NCT00732069|EG001|Reported Event|Valsartan|All subjects receiving valsartan
10934673|NCT00732069|EG002|Reported Event|Placebo|All subjects receiving placebo
10934674|NCT00732160|BG000|Baseline|HS-V/A; LS-V/A|High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
10934675|NCT00732160|BG001|Baseline|HS-A/V; LS-A/V|High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
11176210|NCT02034513|OG001|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
11176211|NCT02034513|EG000|Reported Event|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
11176212|NCT02034513|EG001|Reported Event|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
11176213|NCT02034552|BG000|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
11176214|NCT02034552|BG001|Baseline|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
11176215|NCT02034552|BG002|Baseline|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
11176216|NCT02034552|BG003|Baseline|Total|Total of all reporting groups
11176217|NCT02034552|FG000|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
11176218|NCT02034552|FG001|Participant Flow|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
10934676|NCT00732160|BG002|Baseline|LS-V/A; HS-V/A|Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
10934677|NCT00732160|BG003|Baseline|LS-A/V; HS-A/V|Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
10934678|NCT00732160|BG004|Baseline|Total|Total of all reporting groups
10934679|NCT00732160|FG000|Participant Flow|HS-V/A; LS-V/A|High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
10934680|NCT00732160|FG001|Participant Flow|HS-A/V; LS-A/V|High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
10934681|NCT00732160|FG002|Participant Flow|LS-V/A; HS-V/A|Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
10934682|NCT00732160|FG003|Participant Flow|LS-A/V; HS-A/V|Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
10934683|NCT00732160|OG000|Outcome|Vehicle, HS|Vehicle Infusion, High Salt diet
10934684|NCT00732160|OG001|Outcome|Vehicle, LS|Vehicle Infusion, Low Salt diet
10934685|NCT00732160|OG002|Outcome|Aldosterone, HS|Aldosterone Infusion, High Salt diet
10934686|NCT00732160|OG003|Outcome|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
10934687|NCT00732160|EG000|Reported Event|Vehicle, HS|Vehicle Infusion, High Salt diet
10934688|NCT00732160|EG001|Reported Event|Vehicle, LS|Vehicle Infusion, Low Salt diet
10934689|NCT00732160|EG002|Reported Event|Aldosterone, HS|Aldosterone Infusion, High Salt diet
10934690|NCT00732160|EG003|Reported Event|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
10934691|NCT00732199|BG000|Baseline|Health Young Adults|"Health Young adults, age 18-50 yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
10934692|NCT00732199|BG001|Baseline|Healthy Older Adults|"Healthy Older adults, age >55-60yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
10934693|NCT00732199|BG002|Baseline|Total|Total of all reporting groups
11176219|NCT02034552|FG002|Participant Flow|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
11176220|NCT02034552|OG000|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
11176221|NCT02034552|OG001|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
11176222|NCT02034552|OG002|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
11176223|NCT02034552|EG000|Reported Event|Radium-223|Radium-223
11176224|NCT02034552|EG001|Reported Event|Radium-223 + Abiraterone Acetate + Prednisone|Radium-223 + Abiraterone Acetate + Prednisone
10934694|NCT00732199|FG000|Participant Flow|Arm 1|"Young adults, age 18-59yrs~hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation"
10934695|NCT00732199|FG001|Participant Flow|Arm 2|"Older adults, age >/=60 yrs~hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation"
10934696|NCT00732199|OG000|Outcome|Healthy Young Adults|"Young adults, age 18-50 yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
10934697|NCT00732199|OG001|Outcome|Healthy Old Adults|"Older adults, age >60 yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
10934698|NCT00732199|OG000|Outcome|Healthy Older Adults|Older adults
10934699|NCT00732199|OG000|Outcome|Healthy Young Adults|Young adults
10934700|NCT00732199|OG001|Outcome|Healthy Older Adults|Older adults
10934701|NCT00732199|EG000|Reported Event|Healthy Young Adults|"Young adults, age 18-50 yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
10934702|NCT00732199|EG001|Reported Event|Healthy Older Adults|"Older adults, age >55-60 years~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
10934703|NCT00732225|BG000|Baseline|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
10934704|NCT00732225|BG001|Baseline|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
10934705|NCT00732225|BG002|Baseline|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
10934706|NCT00732225|BG003|Baseline|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
10934707|NCT00732225|BG004|Baseline|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
10934708|NCT00732225|BG005|Baseline|Total|Total of all reporting groups
10934709|NCT00732225|FG000|Participant Flow|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
10934710|NCT00732225|FG001|Participant Flow|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
10934711|NCT00732225|FG002|Participant Flow|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
10934712|NCT00732225|FG003|Participant Flow|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
10934713|NCT00732225|FG004|Participant Flow|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
10934714|NCT00732225|OG000|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
10934715|NCT00732225|OG001|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
11176225|NCT02034552|EG002|Reported Event|Radium-223 + Enzalutamide|Radium-223 + Enzalutamide
11176226|NCT02034565|BG000|Baseline|All Treatment Groups|All Randomized Participants
11176227|NCT02034565|FG000|Participant Flow|Treatment A, Then Treatment B|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.~Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally~Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
11176228|NCT02034565|FG001|Participant Flow|Treatment B, Then Treatment A|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.~Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally~Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
11176229|NCT02034565|OG000|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
10934716|NCT00732225|OG002|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
10934717|NCT00732225|OG003|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
10934718|NCT00732225|OG004|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
10934719|NCT00732225|EG000|Reported Event|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
10934720|NCT00732225|EG001|Reported Event|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
10934721|NCT00732225|EG002|Reported Event|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
10934722|NCT00732225|EG003|Reported Event|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
10934723|NCT00732225|EG004|Reported Event|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
10934724|NCT00732238|BG000|Baseline|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
10934725|NCT00732238|BG001|Baseline|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
10934726|NCT00732238|BG002|Baseline|Total|Total of all reporting groups
10934727|NCT00732238|FG000|Participant Flow|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
10934728|NCT00732238|FG001|Participant Flow|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
10934729|NCT00732238|OG000|Outcome|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
10934730|NCT00732238|OG001|Outcome|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
10934731|NCT00732238|OG000|Outcome|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
10934732|NCT00732238|OG001|Outcome|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
10934733|NCT00732238|EG000|Reported Event|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
10934734|NCT00732238|EG001|Reported Event|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
10934735|NCT00732251|BG000|Baseline|Allopurinol|Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
10934736|NCT00732251|FG000|Participant Flow|Allopurinol|Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
11176230|NCT02034565|OG001|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
10934737|NCT00732251|OG000|Outcome|Allopurinol|Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
10934738|NCT00732251|EG000|Reported Event|Allopurinol|Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
10934739|NCT00732303|BG000|Baseline|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
11176231|NCT02034565|OG000|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
10934740|NCT00732303|FG000|Participant Flow|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
10934741|NCT00732303|OG000|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
10934742|NCT00732303|EG000|Reported Event|Pemetrexed\Radiation|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
10934743|NCT00732472|BG000|Baseline|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
10934744|NCT00732472|BG001|Baseline|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
10934745|NCT00732472|BG002|Baseline|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
10934746|NCT00732472|BG003|Baseline|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
11176232|NCT02034565|OG001|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
11176233|NCT02034565|EG000|Reported Event|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
11176234|NCT02034565|EG001|Reported Event|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
10934747|NCT00732472|BG004|Baseline|Total|Total of all reporting groups
10934748|NCT00732472|FG000|Participant Flow|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
10934749|NCT00732472|FG001|Participant Flow|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
10934750|NCT00732472|FG002|Participant Flow|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
10934751|NCT00732472|FG003|Participant Flow|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
10934752|NCT00732472|OG000|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
10934753|NCT00732472|OG001|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
10934754|NCT00732472|OG002|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
10934755|NCT00732472|OG003|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
11176235|NCT02034578|BG000|Baseline|5mg Apixaban|After a 10 hour fast, participants were randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) administered over 3 periods. Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in the next period.
11240689|NCT02481219|OG001|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
10934756|NCT00732472|OG002|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC19 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
10934757|NCT00732472|EG000|Reported Event|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
10934758|NCT00732472|EG001|Reported Event|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
10934759|NCT00732472|EG002|Reported Event|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
10934760|NCT00732472|EG003|Reported Event|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
10934761|NCT00732498|BG000|Baseline|ESHAP Followed by Zevalin and Rituximab|"Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.~Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin"
10934762|NCT00732498|FG000|Participant Flow|ESHAP Followed by Zevalin and Rituximab|"Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.~Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin"
10934763|NCT00732498|OG000|Outcome|ESHAP Followed by Zevalin and Rituximab|"Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.~Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin"
10934764|NCT00732498|EG000|Reported Event|ESHAP Followed by Zevalin and Rituximab|"Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.~Methylprednisolone: 250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Etoposide: 40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Cytarabine: 2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.~Cisplatin: 25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be admin"
10934765|NCT00732615|BG000|Baseline|Placebo|Matching Placebo: Placebo for subcutaneous injection
11240690|NCT02481219|OG000|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
10934766|NCT00732615|BG001|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
10934767|NCT00732615|BG002|Baseline|Total|Total of all reporting groups
10934768|NCT00732615|FG000|Participant Flow|Placebo|Matching Placebo: Placebo for subcutaneous injection
10934769|NCT00732615|FG001|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
10934770|NCT00732615|OG000|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
10934771|NCT00732615|OG001|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
10934772|NCT00732615|OG001|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
10934773|NCT00732615|EG000|Reported Event|Placebo|Matching Placebo: Placebo for subcutaneous injection
10934774|NCT00732615|EG001|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
10934775|NCT00732641|BG000|Baseline|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
10934776|NCT00732641|BG001|Baseline|No Treatment|Participants were observed and received no treatment
10934777|NCT00732641|BG002|Baseline|Total|Total of all reporting groups
10934778|NCT00732641|FG000|Participant Flow|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
10934779|NCT00732641|FG001|Participant Flow|No Treatment|Participants were observed and received no treatment
10934780|NCT00732641|OG000|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
10934781|NCT00732641|OG001|Outcome|No Treatment|Participants were observed and received no treatment
10934782|NCT00732641|EG000|Reported Event|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
10934783|NCT00732641|EG001|Reported Event|No Treatment|Participants were observed and received no treatment
10934784|NCT00732654|BG000|Baseline|OITA Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
10934785|NCT00732654|BG001|Baseline|OITB Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
10934786|NCT00732654|BG002|Baseline|SLIT Group|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
10934787|NCT00732654|BG003|Baseline|Total|Total of all reporting groups
10934788|NCT00732654|FG000|Participant Flow|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
10934789|NCT00732654|FG001|Participant Flow|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
10934790|NCT00732654|FG002|Participant Flow|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
10934791|NCT00732654|OG000|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
10934792|NCT00732654|OG001|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
10934793|NCT00732654|OG002|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
10934794|NCT00732654|EG000|Reported Event|OITA Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
10934795|NCT00732654|EG001|Reported Event|OITB Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
10934796|NCT00732654|EG002|Reported Event|SLIT Group|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
10934797|NCT00732758|BG000|Baseline|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
10934798|NCT00732758|BG001|Baseline|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
10934799|NCT00732758|BG002|Baseline|Total|Total of all reporting groups
10934800|NCT00732758|FG000|Participant Flow|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
10934801|NCT00732758|FG001|Participant Flow|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
10934802|NCT00732758|OG000|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
11176236|NCT02034578|FG000|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
11176237|NCT02034578|FG001|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
11176238|NCT02034578|FG002|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
10934803|NCT00732758|OG001|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
10934804|NCT00732758|EG000|Reported Event|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
10934805|NCT00732758|EG001|Reported Event|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
10934806|NCT00732875|BG000|Baseline|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
10934807|NCT00732875|FG000|Participant Flow|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
10934808|NCT00732875|OG000|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
10934809|NCT00732875|EG000|Reported Event|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
10934810|NCT00732901|BG000|Baseline|A (Escitalopram)|Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28
10934811|NCT00732901|BG001|Baseline|B (Placebo)|Placebo once daily for days 1-28
10934812|NCT00732901|BG002|Baseline|Total|Total of all reporting groups
10934813|NCT00732901|FG000|Participant Flow|A (Escitalopram)|"Escitalopram~Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28"
10934814|NCT00732901|FG001|Participant Flow|B (Placebo)|"Placebo~Placebo: once daily for days 1-28"
10934815|NCT00732901|OG000|Outcome|A (Escitalopram)|"Escitalopram~Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
10934816|NCT00732901|OG001|Outcome|B (Placebo)|"Placebo~Placebo: daily for days 1-28"
10934817|NCT00732901|EG000|Reported Event|A (Escitalopram)|"Escitalopram~Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28"
10934818|NCT00732901|EG001|Reported Event|B (Placebo)|"Placebo~Placebo: once daily for days 1-28"
10934819|NCT00732940|BG000|Baseline|Belimumab SC Q2WKS|
10934820|NCT00732940|BG001|Baseline|Belimumab SC 3X/WK|
10934821|NCT00732940|BG002|Baseline|Total|Total of all reporting groups
10934822|NCT00732940|FG000|Participant Flow|Belimumab SC Q2WKS|100 mg of belimumab (1 subcutaneous injection) on days 0, 7, and 14, then every other week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
10934823|NCT00732940|FG001|Participant Flow|Belimumab SC 3X/WK|200 mg of belimumab (2 subcutaneous injections of 100 mg each) on days 0, 2, and 4 then 100 mg three times a week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
10934824|NCT00732940|OG000|Outcome|Belimumab SC Q2WKS|
10934825|NCT00732940|OG001|Outcome|Belimumab SC 3X/WK|
10934826|NCT00732940|EG000|Reported Event|Belimumab SC Q2WKS|The Q2wk group will receive 100 mg of belimumab (1 injection) plus standard therapy on Days 0, 7, 14, and then every 2 weeks thereafter.
10934827|NCT00732940|EG001|Reported Event|Belimumab SC 3X/WK|The 3x/wk group will receive 200 mg of belimumab (2 injections of 100 mg each) plus standard therapy on Days 0, 2, and 4 and then 100 mg (1 injection) 3 times per week thereafter.
10934828|NCT00732992|BG000|Baseline|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
10934829|NCT00732992|BG001|Baseline|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
10934830|NCT00732992|BG002|Baseline|Total|Total of all reporting groups
10934831|NCT00732992|FG000|Participant Flow|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
10934832|NCT00732992|FG001|Participant Flow|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
10934833|NCT00732992|OG000|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
10934834|NCT00732992|OG001|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
10934835|NCT00732992|OG000|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
10934836|NCT00732992|EG000|Reported Event|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
10934837|NCT00732992|EG001|Reported Event|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
10934838|NCT00733096|BG000|Baseline|Steroid|Two epidural steroid injections
10934839|NCT00733096|BG001|Baseline|Etanercept|Two epidural etanercept injections
10934840|NCT00733096|BG002|Baseline|Saline|Two epidural saline injections
10934841|NCT00733096|BG003|Baseline|Total|Total of all reporting groups
10934842|NCT00733096|FG000|Participant Flow|Steroid|Two epidural steroid injections
10934843|NCT00733096|FG001|Participant Flow|Etanercept|Two epidural etanercept injections
10934844|NCT00733096|FG002|Participant Flow|Saline|Two epidural saline injections
10934845|NCT00733096|OG000|Outcome|Steroid|Two epidural steroid injections
10934846|NCT00733096|OG001|Outcome|Etanercept|Two epidural etanercept injections
10934847|NCT00733096|OG002|Outcome|Saline|Two epidural saline injections
10934848|NCT00733096|EG000|Reported Event|Steroid|Two epidural steroid injections
10934849|NCT00733096|EG001|Reported Event|Etanercept|Two epidural etanercept injections
10934850|NCT00733096|EG002|Reported Event|Saline|Two epidural saline injections
10934851|NCT00733135|BG000|Baseline|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
10934852|NCT00733135|FG000|Participant Flow|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
10934853|NCT00733135|OG000|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
10934854|NCT00733135|OG000|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk™ plaque excision systems with the SpiderFX™ embolic protection device placed distally.
10934855|NCT00733135|OG000|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
10934856|NCT00733135|EG000|Reported Event|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
10934857|NCT00733226|BG000|Baseline|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
10934858|NCT00733226|BG001|Baseline|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
10934859|NCT00733226|BG002|Baseline|Total|Total of all reporting groups
10934860|NCT00733226|FG000|Participant Flow|Broncho-Vaxom Group|The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
10934861|NCT00733226|FG001|Participant Flow|Placebo Group|The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
10934862|NCT00733226|OG000|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
10934863|NCT00733226|OG001|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
10934864|NCT00733226|EG000|Reported Event|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
10934865|NCT00733226|EG001|Reported Event|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
10934866|NCT00733278|BG000|Baseline|IUD Placement|
10934867|NCT00733278|FG000|Participant Flow|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
10934868|NCT00733278|OG000|Outcome|IUD Placement|IUD placement following removal of placenta at time of elective C-section
10934869|NCT00733278|OG000|Outcome|IUD Strings|Visibility of IUD strings within the vagina at all times.
10934870|NCT00733278|EG000|Reported Event|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
10963366|NCT00871715|FG001|Participant Flow|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
10963367|NCT00871715|FG002|Participant Flow|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
11192084|NCT02136680|FG000|Participant Flow|Patients at Intervention Site|"Staff receives CASA Education:~The intervention is to deliver staff education and training for early integration of palliative skills with ongoing HIV management. Palliative skills for individuals who have little, or no, formal training in palliative care focus on care strategies to relieve suffering and promote quality of life for persons with any chronic illness regardless of the life expectancy. The educational intervention is based upon 8 years' experience in training clinicians how to care for HIV patients using a Train the Trainer method and quality improvement to integrate palliative skills with HIV care and treatment. The model used for this training is standard in chronic disease management and was used by the University of Maryland, Baltimore research team for 8 years in African settings. These skills can be applied to any chronic illness."
10963368|NCT00871715|OG000|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
10963369|NCT00871715|OG001|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
10963370|NCT00871715|OG002|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
10934871|NCT00733291|BG000|Baseline|Nelfilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
10934872|NCT00733291|BG001|Baseline|Etafilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
10934873|NCT00733291|BG002|Baseline|Total|Total of all reporting groups
10934874|NCT00733291|FG000|Participant Flow|Nelfilcon A Soak / Nelfilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
10934875|NCT00733291|FG001|Participant Flow|Nelfilcon A no Soak / Nelfilcon A Soak|Nelfilcon A contact lenses inserted directly out of the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
10934876|NCT00733291|FG002|Participant Flow|Etafilcon A Soak / Etafilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
10934877|NCT00733291|FG003|Participant Flow|Etafilcon A no Soak / Etafilcon Soak|Etafilcon A contact lenses inserted directly out of the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
10934878|NCT00733291|OG000|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
10934879|NCT00733291|OG001|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
10934880|NCT00733291|OG002|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
10934881|NCT00733291|OG003|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
10934882|NCT00733291|OG001|Outcome|Nelfilcon A / No Soak|Nelfilcon A contact lenses inserted directly out of the blister package
10934883|NCT00733291|EG000|Reported Event|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
11192085|NCT02136680|FG001|Participant Flow|Patients at CONTROL Site|"Staff does not receive CASA Education:~Patients at this site receive their usual care."
11192086|NCT02136680|OG000|Outcome|Patients at Intervention Site|Staff receives CASA Education: Basic palliative competencies for outpatient use.
11192087|NCT02136680|OG001|Outcome|Patients at CONTROL Site|Staff does not receive CASA Education: Patients at this site receive their usual care.
10934884|NCT00733291|EG001|Reported Event|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
10934885|NCT00733291|EG002|Reported Event|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
10934886|NCT00733291|EG003|Reported Event|Etafilcon / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
10934887|NCT00733304|BG000|Baseline|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
10934888|NCT00733304|BG001|Baseline|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
10934889|NCT00733304|BG002|Baseline|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
10934890|NCT00733304|BG003|Baseline|Total|Total of all reporting groups
10934891|NCT00733304|FG000|Participant Flow|5 mg/mL TID|Eligible participants received 5 milligram/milliliter (mg/mL) Pazopanib eye drops three times daily for a treatment period of five months.
10934892|NCT00733304|FG001|Participant Flow|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
10934893|NCT00733304|FG002|Participant Flow|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
10934894|NCT00733304|OG000|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
10934895|NCT00733304|OG001|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
10934896|NCT00733304|OG002|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
10934897|NCT00733304|EG000|Reported Event|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
10934898|NCT00733304|EG001|Reported Event|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
10934899|NCT00733304|EG002|Reported Event|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
10934900|NCT00733330|BG000|Baseline|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
10934901|NCT00733330|BG001|Baseline|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
10934902|NCT00733330|BG002|Baseline|Total|Total of all reporting groups
10934903|NCT00733330|FG000|Participant Flow|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
10934904|NCT00733330|FG001|Participant Flow|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
10934905|NCT00733330|OG000|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
11192088|NCT02136680|EG000|Reported Event|Patients at Intervention Site|"Staff receives CASA Education~CASA Education: Basic palliative competencies for outpatient use."
11192089|NCT02136680|EG001|Reported Event|Patients at CONTROL Site|Staff does not receive CASA Education
10934906|NCT00733330|OG001|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
10934907|NCT00733330|OG000|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
10934908|NCT00733330|OG001|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
10934909|NCT00733330|EG000|Reported Event|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
10934910|NCT00733330|EG001|Reported Event|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
10934911|NCT00733343|BG000|Baseline|Treatment Group|"treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)~Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time"
10934912|NCT00733343|BG001|Baseline|Control Group|standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
10934913|NCT00733343|BG002|Baseline|Total|Total of all reporting groups
10934914|NCT00733343|FG000|Participant Flow|Treatment Group|"treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC-american college of cardiology/AHA)~Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time"
10934915|NCT00733343|FG001|Participant Flow|Control Group|standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
10934916|NCT00733343|OG000|Outcome|Treatment Group|"treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)~Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time"
10934917|NCT00733343|OG001|Outcome|Control Group|standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
10934918|NCT00733343|OG000|Outcome|Treatment Group|"treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC-american college of cardiology/AHA)~Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time"
10934919|NCT00733343|EG000|Reported Event|Treatment Group|"treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)~Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time"
11192090|NCT02136810|BG000|Baseline|Included Participants|A convenience sample of 200 ambulatory patients scheduled for surgery was recruited during their preadmission visit at Yale-New Haven Hospital between November 2015 and December 2016. Inclusion criteria were age ≥21 years and a screening BP ≥ 130/85 mm Hg.
10934920|NCT00733343|EG001|Reported Event|Control Group|standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
10934921|NCT00733356|BG000|Baseline|ADHD With Vyvanse Treatment|All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
10934922|NCT00733356|FG000|Participant Flow|ADHD With Vyvanse Treatment|All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
10934923|NCT00733356|OG000|Outcome|ADHD With Vyvanse Treatment|All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
10934924|NCT00733356|EG000|Reported Event|ADHD With Vyvanse Treatment|All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
10934925|NCT00733369|BG000|Baseline|PFC Sigma RP-F|"125 patients to be allocated to this arm according to blinding envelopes~PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing"
10934926|NCT00733369|BG001|Baseline|PFC Sigma RP|"125 patients to be allocated to this arm according to blinding envelopes~PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing"
10934927|NCT00733369|BG002|Baseline|Total|Total of all reporting groups
10934928|NCT00733369|FG000|Participant Flow|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
10934929|NCT00733369|FG001|Participant Flow|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
10934930|NCT00733369|OG000|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
10934931|NCT00733369|OG001|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
10934932|NCT00733369|EG000|Reported Event|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
10934933|NCT00733369|EG001|Reported Event|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
10934934|NCT00733408|BG000|Baseline|Tx (Chemo, MoAb, and Enzyme Inhibitor)|"INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~bevacizumab: Given IV~erlotinib hydrochloride: Given PO"
10934935|NCT00733408|FG000|Participant Flow|Tx (Chemo, MoAb, and Enzyme Inhibitor)|"INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~bevacizumab: Given IV~erlotinib hydrochloride: Given PO"
10934936|NCT00733408|OG000|Outcome|Tx (Chemo, MoAb, and Enzyme Inhibitor)|"INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~bevacizumab: Given IV~erlotinib hydrochloride: Given PO"
11192091|NCT02136810|FG000|Participant Flow|Included Participants|A convenience sample of 200 ambulatory patients scheduled for surgery was recruited during their preadmission visit at Yale-New Haven Hospital between November 2015 and December 2016. Inclusion criteria were age ≥21 years and a screening BP ≥ 130/85 mm Hg.
11192092|NCT02136810|OG000|Outcome|Included Participants|A convenience sample of 200 ambulatory patients scheduled for surgery was recruited during their preadmission visit at Yale-New Haven Hospital between November 2015 and December 2016. Inclusion criteria were age ≥21 years and a screening BP ≥ 130/85 mm Hg.
11192093|NCT02136810|EG000|Reported Event|Included Participants|A convenience sample of 200 ambulatory patients scheduled for surgery was recruited during their preadmission visit at Yale-New Haven Hospital between November 2015 and December 2016. Inclusion criteria were age ≥21 years and a screening BP ≥ 130/85 mm Hg.
11192094|NCT02136914|BG000|Baseline|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
11192095|NCT02136914|BG001|Baseline|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
11192096|NCT02136914|BG002|Baseline|Total|Total of all reporting groups
11192097|NCT02136914|FG000|Participant Flow|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
11192098|NCT02136914|FG001|Participant Flow|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine hydrochloride [HCl] extended release): oral capsules administered once nightly at bedtime for 25 weeks
11192099|NCT02136914|OG000|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
11192100|NCT02136914|OG001|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
11192101|NCT02136914|EG000|Reported Event|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
11192102|NCT02136914|EG001|Reported Event|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
11192103|NCT02137226|BG000|Baseline|BI 695501|Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution for injection, administered by subcutaneous (SC) injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
11192104|NCT02137226|BG001|Baseline|US-licensed Humira®|Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
11192105|NCT02137226|BG002|Baseline|Total|Total of all reporting groups
11192106|NCT02137226|FG000|Participant Flow|BI 695501|Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution for injection, administered by subcutaneous (SC) injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
11192107|NCT02137226|FG001|Participant Flow|US-licensed Humira®|Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
11192108|NCT02137226|FG002|Participant Flow|BI 695501 to BI 695501|Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2. Each patient received 40 mg/0.8 mL BI 695501 solution for injection, administered by SC injection every 2 weeks from Week 24 to Week 48.
11192109|NCT02137226|FG003|Participant Flow|US-licensed Humira® to US-licensed Humira®|Patients initially randomized to US-licensed Humira® in Period 1 and re-randomized to US-licensed Humira® in Period 2. Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks from Week 24 to Week 48.
11192110|NCT02137226|FG004|Participant Flow|US-licensed Humira® to BI 695501|Patients initially randomized to US-licensed Humira® in Period 1 and re-randomized to BI 695501 in Period 2. Each patient received 40 mg/0.8 mL US-licenced Humira® in period 1 and 40 mg/0.8 mL BI 695501 solution for injection, administered by SC injection every 2 weeks from Week 24 to Week 48.
11192111|NCT02137226|OG000|Outcome|BI 695501|Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution for injection, administered by subcutaneous (SC) injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
11192112|NCT02137226|OG001|Outcome|US-licensed Humira®|Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
11192113|NCT02137226|OG000|Outcome|BI 695501 Continuously|BI 695501 continuously comprised all patients randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 (or not re randomized at Week 24). This group represents all patients who were to receive BI 695501 from Day 1 to Week 48. Each patient received 40 mg/0.8 mL BI 695501 solution for injection, administered by SC injection every 2 weeks.
11192114|NCT02137226|OG001|Outcome|US-licensed Humira® Continuously|Humira® US continuously comprised all patients randomized to US-licensed Humira® in Period 1 and re-randomized to US-licensed Humira® in Period 2 or not re randomized at Week 24 (e.g. patients who discontinued treatment prior to Week 24). This group represents all patients who were to receive US-licensed Humira® from Day 1 to Week 48. Each patient received 40 mg/0.8 mL US-licensed Humira® solution for injection, administered by SC injection every 2 weeks.
11192115|NCT02137226|EG000|Reported Event|BI 695501 Continuously|BI 695501 continuously comprised all patients randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 (or not re randomized at Week 24). This group represents all patients who were to receive BI 695501 from Day 1 to Week 48. Each patient received 40 mg/0.8 mL BI 695501 solution for injection, administered by SC injection every 2 weeks.
10934937|NCT00733408|EG000|Reported Event|Tx (Chemo, MoAb, and Enzyme Inhibitor)|"INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~bevacizumab: Given IV~erlotinib hydrochloride: Given PO"
10934938|NCT00733421|BG000|Baseline|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
10934939|NCT00733421|BG001|Baseline|Control Tramadol|Tramadol 100 mg slow release twice daily
10934940|NCT00733421|BG002|Baseline|Total|Total of all reporting groups
10934941|NCT00733421|FG000|Participant Flow|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
10934942|NCT00733421|FG001|Participant Flow|Control Tramadol|Tramadol 100 mg slow release twice daily
10934943|NCT00733421|OG000|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
10934944|NCT00733421|OG001|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
11176239|NCT02034578|FG003|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
11176240|NCT02034578|FG004|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
11176241|NCT02034578|FG005|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
10934945|NCT00733421|EG000|Reported Event|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
10934946|NCT00733421|EG001|Reported Event|Control Tramadol|Tramadol 100 mg slow release twice daily
10934947|NCT00733499|BG000|Baseline|LCS Complete Duofix|LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
10934948|NCT00733499|BG001|Baseline|LCS Complete Porocoat|LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
10934949|NCT00733499|BG002|Baseline|Total|Total of all reporting groups
10934950|NCT00733499|FG000|Participant Flow|LCS Complete Duofix|LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
10934951|NCT00733499|FG001|Participant Flow|LCS Complete Porocoat|LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
10934952|NCT00733499|OG000|Outcome|LCS Complete Duofix|LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
10934953|NCT00733499|OG001|Outcome|LCS Complete Porocoat|LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
10934954|NCT00733499|EG000|Reported Event|LCS Complete Duofix|LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
10934955|NCT00733499|EG001|Reported Event|LCS Complete Porocoat|LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
10934956|NCT00733512|BG000|Baseline|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
10934957|NCT00733512|FG000|Participant Flow|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
10934958|NCT00733512|OG000|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
10934959|NCT00733512|EG000|Reported Event|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
11176242|NCT02034578|OG000|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
11176243|NCT02034578|OG001|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
10934960|NCT00733746|BG000|Baseline|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
10934961|NCT00733746|FG000|Participant Flow|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
10934962|NCT00733746|OG000|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
10934963|NCT00733746|EG000|Reported Event|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
10934964|NCT00733824|BG000|Baseline|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934965|NCT00733824|BG001|Baseline|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934966|NCT00733824|BG002|Baseline|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934967|NCT00733824|BG003|Baseline|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934968|NCT00733824|BG004|Baseline|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934969|NCT00733824|BG005|Baseline|Total|Total of all reporting groups
11176244|NCT02034578|OG002|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
10934970|NCT00733824|FG000|Participant Flow|Phase I - Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934971|NCT00733824|FG001|Participant Flow|Phase I - Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934972|NCT00733824|FG002|Participant Flow|Phase I - Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
11176245|NCT02034578|OG000|Outcome|5mg Apixaban|After a 10 hour fast, participants were randomized on Day 1 of Period 1 to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in Period 2 and Period 3.
10934973|NCT00733824|FG003|Participant Flow|Phase I - Cohort 4|240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
10934974|NCT00733824|FG004|Participant Flow|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934975|NCT00733824|OG000|Outcome|Phase 1 (Dose Levels 1-4)|
10934976|NCT00733824|OG000|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934977|NCT00733824|OG001|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934978|NCT00733824|OG002|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934979|NCT00733824|OG003|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934980|NCT00733824|OG000|Outcome|Phase 1 and Phase 2 Participants|
10934981|NCT00733824|OG004|Outcome|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)~AMD3100~G-CSF~Apheresis"
10934982|NCT00733824|EG000|Reported Event|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934983|NCT00733824|EG001|Reported Event|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
11192116|NCT02137226|EG001|Reported Event|US-licensed Humira® Continuously|Humira® US continuously comprised all patients randomized to US-licensed Humira® in Period 1 and re-randomized to US-licensed Humira® in Period 2 or not re randomized at Week 24 (e.g. patients who discontinued treatment prior to Week 24). This group represents all patients who were to receive US-licensed Humira® from Day 1 to Week 48. Each patient received 40 mg/0.8 mL US-licensed Humira® solution for injection, administered by SC injection every 2 weeks.
10934984|NCT00733824|EG002|Reported Event|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934985|NCT00733824|EG003|Reported Event|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934986|NCT00733824|EG004|Reported Event|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
10934987|NCT00733902|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934988|NCT00733902|BG001|Baseline|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934989|NCT00733902|BG002|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934990|NCT00733902|BG003|Baseline|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934991|NCT00733902|BG004|Baseline|Total|Total of all reporting groups
10934992|NCT00733902|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934993|NCT00733902|FG001|Participant Flow|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934994|NCT00733902|FG002|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934995|NCT00733902|FG003|Participant Flow|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934996|NCT00733902|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934997|NCT00733902|OG001|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934998|NCT00733902|OG002|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10934999|NCT00733902|OG003|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10935000|NCT00733902|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10935001|NCT00733902|EG001|Reported Event|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10935002|NCT00733902|EG002|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10935003|NCT00733902|EG003|Reported Event|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10935004|NCT00733954|BG000|Baseline|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
10935005|NCT00733954|BG001|Baseline|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
10935006|NCT00733954|BG002|Baseline|Total|Total of all reporting groups
10935007|NCT00733954|FG000|Participant Flow|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
10935008|NCT00733954|FG001|Participant Flow|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
10935009|NCT00733954|OG000|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
10935010|NCT00733954|OG001|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
10935011|NCT00733954|EG000|Reported Event|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
10935012|NCT00733954|EG001|Reported Event|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
10935013|NCT00733980|BG000|Baseline|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
10935014|NCT00733980|BG001|Baseline|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
10935015|NCT00733980|BG002|Baseline|Total|Total of all reporting groups
10935016|NCT00733980|FG000|Participant Flow|GSK561679|The participants in this arm received GSK561679, 350 milligram (mg) orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks.
10935017|NCT00733980|FG001|Participant Flow|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening.
10935018|NCT00733980|OG000|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
10935019|NCT00733980|OG001|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
10935020|NCT00733980|OG000|Outcome|GSK561679|The participants in this arm received GSK561679, 350 milligram (mg) orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
10935021|NCT00733980|EG000|Reported Event|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
10935022|NCT00733980|EG001|Reported Event|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
10935023|NCT00733993|BG000|Baseline|Cocaine Users|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
10935024|NCT00733993|BG001|Baseline|Control Participants|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
10935025|NCT00733993|BG002|Baseline|Total|Total of all reporting groups
10935026|NCT00733993|FG000|Participant Flow|Cocaine Users|"Cocaine users were allocated to different sequence orders for the 5 interventions~Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
10935027|NCT00733993|FG001|Participant Flow|Control Participants|"Control participants were allocated to different sequence orders for the 5 interventions~Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
10935028|NCT00733993|OG000|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
10935029|NCT00733993|OG001|Outcome|Caffeine 150 Mg|150 MG of Caffeine
10935030|NCT00733993|OG002|Outcome|Caffeine 300 mg|Caffeine 300 mg
10935031|NCT00733993|OG003|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
10935032|NCT00733993|OG002|Outcome|Caffeine 300 mg|Caffeine 300mg
10935033|NCT00733993|OG003|Outcome|Amphetamine 20mg|Amphetamine 20mg
10935034|NCT00733993|EG000|Reported Event|1 Caffeine|"Caffeine~Caffeine: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
10935035|NCT00733993|EG001|Reported Event|2 Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
10935036|NCT00733993|EG002|Reported Event|3 Amphetamine|Amphetamine: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
10935037|NCT00734032|BG000|Baseline|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935038|NCT00734032|BG001|Baseline|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935039|NCT00734032|BG002|Baseline|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935040|NCT00734032|BG003|Baseline|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935041|NCT00734032|BG004|Baseline|Total|Total of all reporting groups
10935042|NCT00734032|FG000|Participant Flow|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935043|NCT00734032|FG001|Participant Flow|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935044|NCT00734032|FG002|Participant Flow|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935045|NCT00734032|FG003|Participant Flow|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935046|NCT00734032|OG000|Outcome|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935047|NCT00734032|OG001|Outcome|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935048|NCT00734032|OG002|Outcome|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935049|NCT00734032|OG003|Outcome|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935050|NCT00734032|EG000|Reported Event|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935051|NCT00734032|EG001|Reported Event|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935052|NCT00734032|EG002|Reported Event|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935053|NCT00734032|EG003|Reported Event|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
10935054|NCT00734071|BG000|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10935055|NCT00734071|BG001|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
10935056|NCT00734071|BG002|Baseline|Total|Total of all reporting groups
10935057|NCT00734071|FG000|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10935058|NCT00734071|FG001|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
10935059|NCT00734071|OG000|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10935060|NCT00734071|OG001|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
10935061|NCT00734071|EG000|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10935062|NCT00734071|EG001|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
10935063|NCT00734097|BG000|Baseline|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
10935064|NCT00734097|FG000|Participant Flow|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
10935065|NCT00734097|OG000|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
10935066|NCT00734097|EG000|Reported Event|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
10935067|NCT00734149|BG000|Baseline|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
10935068|NCT00734149|FG000|Participant Flow|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
10935069|NCT00734149|OG000|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
10935070|NCT00734149|OG000|Outcome|Bortezomib+Melphalan+Prednisone: Non-ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients did not proceed to autologous stem cell transplant (ASCT).
10935071|NCT00734149|OG001|Outcome|Bortezomib+Melphalan+Prednisone: ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients proceeded to autologous stem cell transplant (ASCT).
10935072|NCT00734149|EG000|Reported Event|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
10935073|NCT00734162|BG000|Baseline|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935074|NCT00734162|BG001|Baseline|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935075|NCT00734162|BG002|Baseline|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935076|NCT00734162|BG003|Baseline|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935077|NCT00734162|BG004|Baseline|Total|Total of all reporting groups
10935078|NCT00734162|FG000|Participant Flow|TDF 12-14 Years|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935079|NCT00734162|FG001|Participant Flow|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935080|NCT00734162|FG002|Participant Flow|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935081|NCT00734162|FG003|Participant Flow|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935082|NCT00734162|OG000|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
11176246|NCT02034578|EG000|Reported Event|5mg Apixaban Via Oral Syringe (A)|"After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences administered over 3 Periods (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3.~In Treatment A the single dose of 5 mg apixaban was administered via oral syringe."
11176247|NCT02034578|EG001|Reported Event|5mg Apixaban Via NGT Followed by D5W (B)|In Treatment B the single dose of 5 mg apixaban was administered via nasogastric tube (NGT) followed by 60 mL of dextrose, water (D5W) via the NGT.
11176248|NCT02034578|EG002|Reported Event|5 mg Apixaban Via NGT Followed by Infant Formula (C)|In Treatment C, the single dose of 5 mg apixaban was administered via NGT, followed by 60 mL of infant formula via the NGT.
11176249|NCT02034591|BG000|Baseline|All Treatment Groups|All Randomized Participants
11176250|NCT02034591|FG000|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
11176251|NCT02034591|FG001|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
11176252|NCT02034591|FG002|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
11176253|NCT02034591|FG003|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
11176254|NCT02034591|FG004|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
11176255|NCT02034591|FG005|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
11176256|NCT02034591|OG000|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
11176257|NCT02034591|OG001|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
11176258|NCT02034591|OG001|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
11176259|NCT02034591|OG002|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
11176260|NCT02034591|EG000|Reported Event|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
11176261|NCT02034591|EG001|Reported Event|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
11176262|NCT02034591|EG002|Reported Event|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
11176263|NCT02034708|BG000|Baseline|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
10935083|NCT00734162|OG001|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935084|NCT00734162|OG002|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935085|NCT00734162|OG003|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935086|NCT00734162|OG004|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935087|NCT00734162|OG005|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
11176264|NCT02034708|BG001|Baseline|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
11176265|NCT02034708|BG002|Baseline|Total|Total of all reporting groups
11176266|NCT02034708|FG000|Participant Flow|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
11176267|NCT02034708|FG001|Participant Flow|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
11176268|NCT02034708|OG000|Outcome|Gadovist® (Reader 1)|Patients who received Gadovist® Results for reader 1
11176269|NCT02034708|OG001|Outcome|Dotarem® (Reader 1)|Patients who received Dotarem® Results for reader 1
11176270|NCT02034708|OG002|Outcome|Gadovist® (Reader 2)|Patients who received Gadovist® Results for reader 2
11176271|NCT02034708|OG003|Outcome|Dotarem® (Reader 2)|Patients who received Dotarem® Results for reader 2
11176272|NCT02034708|OG004|Outcome|Gadovist® (Reader 3)|Patients who received Gadovist® Results for reader 3
11176273|NCT02034708|OG005|Outcome|Dotarem® (Reader 3)|Patients who received Dotarem® Results for reader 3
10935088|NCT00734162|OG000|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935089|NCT00734162|OG001|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
10935090|NCT00734162|EG000|Reported Event|Double-Blind TDF|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received double-blind TDF during the Randomized Phase of the study.
10935091|NCT00734162|EG001|Reported Event|Double-Blind Placebo|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received placebo during the Randomized Phase of the study.
10935092|NCT00734162|EG002|Reported Event|Open-Label TDF-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received double-blind TDF during the Randomized Phase of the study and continued to the Open-Label Phase.
10935093|NCT00734162|EG003|Reported Event|Open-Label Placebo-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received placebo during the Randomized Phase of the study and continued to the Open-Label Phase.
10935094|NCT00734214|BG000|Baseline|0.9% NaCl|
10935095|NCT00734214|BG001|Baseline|0.45% NaCl|
10935096|NCT00734214|BG002|Baseline|Total|Total of all reporting groups
10935097|NCT00734214|FG000|Participant Flow|0.9% NaCl|
10935098|NCT00734214|FG001|Participant Flow|0.45% NaCl|
10935099|NCT00734214|OG000|Outcome|0.9% NaCl|
10935100|NCT00734214|OG001|Outcome|0.45% NaCl|
10935101|NCT00734214|EG000|Reported Event|0.9% NaCl|
10935102|NCT00734214|EG001|Reported Event|0.45% NaCl|
10935103|NCT00734305|BG000|Baseline|MM-121 Dose Escalation|MM-121: Dose escalation Frequency - once weekly IV
10935104|NCT00734305|BG001|Baseline|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
10935105|NCT00734305|BG002|Baseline|Total|Total of all reporting groups
10935106|NCT00734305|FG000|Participant Flow|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
10935107|NCT00734305|FG001|Participant Flow|Dose Escalation: Cohort 2|MM-121: 6 mg/kg IV QW
10935108|NCT00734305|FG002|Participant Flow|Dose Escalation: Cohort 3|MM-121: 10 mg/kg IV QW
10935109|NCT00734305|FG003|Participant Flow|Dose Escalation: Cohort 4|MM-121: 15 mg/kg IV QW
10935110|NCT00734305|FG004|Participant Flow|Dose Escalation: Cohort 5|MM-121: 20 mg/kg IV QW
11176274|NCT02034708|EG000|Reported Event|Dotarem®|Patients who received Dotarem®
11176275|NCT02034708|EG001|Reported Event|Gadovist®|Patients who received Gadovist®
11176276|NCT02034708|EG002|Reported Event|Total|Patients who received at least one injection of contrast agent
11176277|NCT02034799|BG000|Baseline|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH). Standard of Care (SoC)
11176278|NCT02034799|BG001|Baseline|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen Bioseal Fibrin Sealant
11176279|NCT02034799|BG002|Baseline|Total|Total of all reporting groups
11176280|NCT02034799|FG000|Participant Flow|Standard of Care (SoC)|SoC include Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
11176281|NCT02034799|FG001|Participant Flow|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
11176282|NCT02034799|OG000|Outcome|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
10935111|NCT00734305|FG005|Participant Flow|Dose Escalation: Cohort 6|MM-121: 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
10935112|NCT00734305|FG006|Participant Flow|Expansion Cohort|(Highest tested dose in absence of reaching maximum tolerated dose) 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
10935113|NCT00734305|OG000|Outcome|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
10935114|NCT00734305|OG001|Outcome|Dose Escalation: Cohort 2|MM-121 6 mg/kg IV QW
11176283|NCT02034799|OG001|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
10935115|NCT00734305|OG002|Outcome|Dose Escalation: Cohort 3|MM-121 10 mg/kg IV QW
10935116|NCT00734305|OG003|Outcome|Dose Escalation: Cohort 4|MM-121 15 mg/kg IV QW
10935117|NCT00734305|OG004|Outcome|Dose Escalation: Cohort 5|MM-121 20 mg/kg IV QW
10935118|NCT00734305|OG005|Outcome|Dose Escalation: Cohort 6|MM-121 40 mg/kg IV loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV weekly maintenance doses
10935119|NCT00734305|OG006|Outcome|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
10935120|NCT00734305|OG000|Outcome|Dose Escalation: All Participants|MM-121: Dose escalation Frequency - once weekly
11176284|NCT02034799|EG000|Reported Event|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
10935121|NCT00734305|OG000|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
10935122|NCT00734305|OG001|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
10935123|NCT00734305|OG002|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
10935124|NCT00734305|OG003|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
10935125|NCT00734305|OG004|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
10935126|NCT00734305|OG005|Outcome|Cohort 6|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses
10935127|NCT00734305|OG005|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
10935128|NCT00734305|EG000|Reported Event|All Participatants|Dose Escalation cohort participants + Expansion cohort participants
10935129|NCT00734344|BG000|Baseline|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
10935130|NCT00734344|BG001|Baseline|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
10935131|NCT00734344|BG002|Baseline|Total|Total of all reporting groups
10935132|NCT00734344|FG000|Participant Flow|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
10935133|NCT00734344|FG001|Participant Flow|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
10935134|NCT00734344|OG000|Outcome|Raltegravir Plus Truvada|Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
10935135|NCT00734344|OG001|Outcome|Efavirenz Plus Truvada|Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
10935136|NCT00734344|OG000|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
10935137|NCT00734344|OG001|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
10935138|NCT00734344|EG000|Reported Event|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
10935139|NCT00734344|EG001|Reported Event|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
10935140|NCT00734409|BG000|Baseline|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
10935141|NCT00734409|BG001|Baseline|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
10935142|NCT00734409|BG002|Baseline|Total|Total of all reporting groups
10935143|NCT00734409|FG000|Participant Flow|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
10935144|NCT00734409|FG001|Participant Flow|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
10935145|NCT00734409|OG000|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
10935146|NCT00734409|OG001|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
10935147|NCT00734409|EG000|Reported Event|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
10935148|NCT00734409|EG001|Reported Event|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
10935149|NCT00734474|BG000|Baseline|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
11176285|NCT02034799|EG001|Reported Event|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
11176286|NCT02034877|BG000|Baseline|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
11176287|NCT02034877|BG001|Baseline|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
10935150|NCT00734474|BG001|Baseline|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
10935151|NCT00734474|BG002|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935152|NCT00734474|BG003|Baseline|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
10935153|NCT00734474|BG004|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935154|NCT00734474|BG005|Baseline|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
10935155|NCT00734474|BG006|Baseline|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
10935156|NCT00734474|BG007|Baseline|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935157|NCT00734474|BG008|Baseline|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935158|NCT00734474|BG009|Baseline|Total|Total of all reporting groups
10935159|NCT00734474|FG000|Participant Flow|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
10935160|NCT00734474|FG001|Participant Flow|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
10935161|NCT00734474|FG002|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935162|NCT00734474|FG003|Participant Flow|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
10935163|NCT00734474|FG004|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935164|NCT00734474|FG005|Participant Flow|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
10935165|NCT00734474|FG006|Participant Flow|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
10935166|NCT00734474|FG007|Participant Flow|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935167|NCT00734474|FG008|Participant Flow|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935168|NCT00734474|OG000|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935169|NCT00734474|OG001|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935170|NCT00734474|OG002|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935171|NCT00734474|OG000|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
10935172|NCT00734474|OG001|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
10935173|NCT00734474|OG002|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935174|NCT00734474|OG003|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
10935175|NCT00734474|OG004|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935176|NCT00734474|OG005|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
10935177|NCT00734474|OG006|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
10935178|NCT00734474|OG007|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935179|NCT00734474|OG008|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935180|NCT00734474|OG003|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935181|NCT00734474|OG000|Outcome|LY2189265|"LY2189265 (Dulaglutide): 3.0, 2.0, 1.5, 1.0, 0.75, 0.5, or 0.25 milligrams (mg), subcutaneous (SC), once weekly for up to 104 weeks.~Placebo: tablet, administered orally, once daily for up to 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks"
10935182|NCT00734474|OG009|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935183|NCT00734474|EG000|Reported Event|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
10935184|NCT00734474|EG001|Reported Event|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
10935185|NCT00734474|EG002|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935186|NCT00734474|EG003|Reported Event|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
10935187|NCT00734474|EG004|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally, for 104 weeks"
11176288|NCT02034877|BG002|Baseline|Total|Total of all reporting groups
11176289|NCT02034877|FG000|Participant Flow|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
11176290|NCT02034877|FG001|Participant Flow|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
10935188|NCT00734474|EG005|Reported Event|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
11176291|NCT02034877|OG000|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
11176292|NCT02034877|OG001|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
11176293|NCT02034877|EG000|Reported Event|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
11176294|NCT02034877|EG001|Reported Event|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
11176295|NCT02034916|BG000|Baseline|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
11176296|NCT02034916|BG001|Baseline|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
11176297|NCT02034916|BG002|Baseline|Total|Total of all reporting groups
11176298|NCT02034916|FG000|Participant Flow|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 milligram (mg) orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
11176299|NCT02034916|FG001|Participant Flow|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
11176300|NCT02034916|OG000|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
11176301|NCT02034916|OG001|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
11176302|NCT02034916|OG000|Outcome|Cohort 1 + Cohort 2: Talazoparib 1 mg|Participants, who either responded to a prior platinum-containing treatment for metastatic breast cancer or had more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. For the participants with non-platinum chemotherapy, prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
11176303|NCT02034916|EG000|Reported Event|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
11192117|NCT02137369|BG000|Baseline|SSRI|Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily, for 12 weeks
11192118|NCT02137369|BG001|Baseline|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour standardized sessions provided over 12 weeks.
11192119|NCT02137369|BG002|Baseline|Total|Total of all reporting groups
11192120|NCT02137369|FG000|Participant Flow|SSRI|Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily for 12 weeks.
10935189|NCT00734474|EG006|Reported Event|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
10935190|NCT00734474|EG007|Reported Event|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935191|NCT00734474|EG008|Reported Event|Placebo/Sitagliptin (Baseline Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily, for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
10935192|NCT00734500|BG000|Baseline|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
10935193|NCT00734500|FG000|Participant Flow|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
10935194|NCT00734500|OG000|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
10935195|NCT00734500|EG000|Reported Event|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
10935196|NCT00734539|BG000|Baseline|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
10935197|NCT00734539|BG001|Baseline|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
10935198|NCT00734539|BG002|Baseline|Total|Total of all reporting groups
10935199|NCT00734539|FG000|Participant Flow|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
10935200|NCT00734539|FG001|Participant Flow|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
10935201|NCT00734539|OG000|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
10935202|NCT00734539|OG001|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
10935203|NCT00734539|OG000|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
10935204|NCT00734539|OG001|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly for a total of up to 12-13 doses"
10935205|NCT00734539|OG001|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for a total of up to 12-13 doses"
10935206|NCT00734539|EG000|Reported Event|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
10935207|NCT00734539|EG001|Reported Event|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
10935208|NCT00734578|BG000|Baseline|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
10935209|NCT00734578|BG001|Baseline|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
10935210|NCT00734578|BG002|Baseline|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
10935211|NCT00734578|BG003|Baseline|Total|Total of all reporting groups
10935212|NCT00734578|FG000|Participant Flow|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
10935213|NCT00734578|FG001|Participant Flow|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
10935214|NCT00734578|FG002|Participant Flow|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
10935215|NCT00734578|OG000|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
11176304|NCT02034916|EG001|Reported Event|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
10935216|NCT00734578|OG001|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
10935217|NCT00734578|OG002|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
10935218|NCT00734578|EG000|Reported Event|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
10935219|NCT00734578|EG001|Reported Event|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
10935220|NCT00734578|EG002|Reported Event|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
10935221|NCT00734591|BG000|Baseline|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
10935222|NCT00734591|BG001|Baseline|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
10935223|NCT00734591|BG002|Baseline|Total|Total of all reporting groups
10935224|NCT00734591|FG000|Participant Flow|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
10935225|NCT00734591|FG001|Participant Flow|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
10935226|NCT00734591|OG000|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
10935227|NCT00734591|OG001|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
10935228|NCT00734591|EG000|Reported Event|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
10935229|NCT00734591|EG001|Reported Event|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
10935230|NCT00734604|BG000|Baseline|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
10935231|NCT00734604|BG001|Baseline|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
10935232|NCT00734604|BG002|Baseline|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
10935233|NCT00734604|BG003|Baseline|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
10935234|NCT00734604|BG004|Baseline|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
11192121|NCT02137369|FG001|Participant Flow|Cognitive Behavioral Therapy|"Cognitive Behavioral Therapy (CBT)~Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 1-hour sessions over 12 weeks."
11176305|NCT02035202|BG000|Baseline|CBT2go|"Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.~CBT2go: CBT administered using mobile intervention.~Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm."
11176306|NCT02035202|BG001|Baseline|EMA-only|"Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.~Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm."
11176307|NCT02035202|BG002|Baseline|Standard Care|Participants assigned to this condition will only participate in the assessments.
11176308|NCT02035202|BG003|Baseline|Total|Total of all reporting groups
11176309|NCT02035202|FG000|Participant Flow|CBT2go|"Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.~CBT2go: CBT administered using mobile intervention.~Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm."
11176310|NCT02035202|FG001|Participant Flow|EMA-only|"Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.~Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm."
11176311|NCT02035202|FG002|Participant Flow|Standard Care|Participants assigned to this condition will only participate in the assessments.
11176312|NCT02035202|OG000|Outcome|CBT2go|"Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.~CBT2go: CBT administered using mobile intervention.~Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm."
11176313|NCT02035202|OG001|Outcome|EMA-only|"Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.~Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm."
11176314|NCT02035202|OG002|Outcome|Standard Care|Participants assigned to this condition will only participate in the assessments.
11176315|NCT02035202|EG000|Reported Event|CBT2go|"Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.~CBT2go: CBT administered using mobile intervention.~Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm."
11176316|NCT02035202|EG001|Reported Event|EMA-only|"Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.~Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm."
11176317|NCT02035202|EG002|Reported Event|Standard Care|Participants assigned to this condition will only participate in the assessments.
11176318|NCT02035267|BG000|Baseline|ATX-101 (Deoxycholic Acid) Injection - Grade 1|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176319|NCT02035267|BG001|Baseline|Placebo Injection - Grade 1|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176320|NCT02035267|BG002|Baseline|ATX-101 (Deoxycholic Acid) Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176321|NCT02035267|BG003|Baseline|Placebo Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176322|NCT02035267|BG004|Baseline|Total|Total of all reporting groups
11176323|NCT02035267|FG000|Participant Flow|ATX-101 (Deoxycholic Acid) Injection - Grade 1|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176324|NCT02035267|FG001|Participant Flow|Placebo Injection - Grade 1|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10935235|NCT00734604|BG005|Baseline|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
10935236|NCT00734604|BG006|Baseline|Total|Total of all reporting groups
10935237|NCT00734604|FG000|Participant Flow|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
10935238|NCT00734604|FG001|Participant Flow|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
10935239|NCT00734604|FG002|Participant Flow|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
10935240|NCT00734604|FG003|Participant Flow|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
10935241|NCT00734604|FG004|Participant Flow|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
10935242|NCT00734604|FG005|Participant Flow|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
10935243|NCT00734604|OG000|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
10935244|NCT00734604|OG001|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
10935245|NCT00734604|OG001|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
10935246|NCT00734604|OG002|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
10935247|NCT00734604|OG001|Outcome|Tadalafil as Needed [T(PRN)]|tadalafil 20 mg as needed [T(PRN)]
10935248|NCT00734604|OG002|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
10935249|NCT00734604|EG000|Reported Event|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
10935250|NCT00734604|EG001|Reported Event|Sildenafil Citrate as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
10935251|NCT00734604|EG002|Reported Event|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
10935252|NCT00734617|BG000|Baseline|Less Dependent|
10935253|NCT00734617|BG001|Baseline|More Dependent|
10935254|NCT00734617|BG002|Baseline|Total|Total of all reporting groups
10935255|NCT00734617|FG000|Participant Flow|Less Dependent|
10935256|NCT00734617|FG001|Participant Flow|More Dependent|
10935257|NCT00734617|OG000|Outcome|Less Dependent|
10935258|NCT00734617|OG001|Outcome|More Dependent|
10935259|NCT00734617|EG000|Reported Event|Less Dependent|
10935260|NCT00734617|EG001|Reported Event|More Dependent|
10935261|NCT00734630|BG000|Baseline|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
10935262|NCT00734630|BG001|Baseline|Placebo|Matching placebo tablets, oral administration
10935263|NCT00734630|BG002|Baseline|Total|Total of all reporting groups
10935264|NCT00734630|FG000|Participant Flow|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
10935265|NCT00734630|FG001|Participant Flow|Placebo|Matching placebo tablets, oral administration
10935266|NCT00734630|OG000|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
10935267|NCT00734630|OG001|Outcome|Placebo|Matching placebo tablets, oral administration
10935268|NCT00734630|EG000|Reported Event|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
10935269|NCT00734630|EG001|Reported Event|Placebo|Matching placebo tablets, oral administration
10935270|NCT00734656|BG000|Baseline|All Study Participants|All study participants enrolled in Lab Session 1
10935271|NCT00734656|FG000|Participant Flow|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
10935272|NCT00734656|FG001|Participant Flow|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
10935273|NCT00734656|FG002|Participant Flow|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
10935274|NCT00734656|FG003|Participant Flow|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
10935275|NCT00734656|OG000|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
10935276|NCT00734656|OG001|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
10935277|NCT00734656|OG002|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
10935278|NCT00734656|OG003|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
10935279|NCT00734656|EG000|Reported Event|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
10935280|NCT00734656|EG001|Reported Event|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
10935281|NCT00734656|EG002|Reported Event|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
10935282|NCT00734656|EG003|Reported Event|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
11234181|NCT02432287|BG000|Baseline|Metformin FIRST, Then Placebo|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~In the metformin first group, individuals took 1700mg/day metformin in 2 doses for 6 weeks, followed by 2 weeks of washout, and concluding with placebo capsules that matched the metformin for 6 weeks."
11234182|NCT02432287|BG001|Baseline|Placebo FIRST, Then Metformin|In the placebo first group, individuals took placebo capsules that matched metformin for 6 weeks, followed by 2 weeks of washout, and concluding with metformin 1700mg/day (in 2 doses) for 6 weeks.
11234183|NCT02432287|BG002|Baseline|Total|Total of all reporting groups
11234184|NCT02432287|FG000|Participant Flow|Metformin First, Then Placebo|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~Participants in the metformin first group took 1-2 metformin capsules 2 times daily for 6 weeks, followed by a 2 week washout period, concluding with 6 weeks of 1-2 placebo capsules (which matched metformin capsules) 2 x daily."
11234185|NCT02432287|FG001|Participant Flow|Placebo First, Then Metformin|Participants in the placebo first group took 1-2 placebo capsules 2 x daily (which matched metformin capsules) for 6 weeks, followed by a 2 week washout period, concluding with 6 weeks of 1-2 metformin capsules 2x daily.
11234186|NCT02432287|OG000|Outcome|Metformin Treatment|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~Participants took metformin (1700 mg/day) for 6 weeks, followed by a 2 week washout, concluding with placebo pills (that matched metformin) for 6 weeks."
11234187|NCT02432287|OG001|Outcome|Placebo Treatment|Participants took placebo that matched metformin for 6 weeks.
11234188|NCT02432287|OG000|Outcome|Metformin Treatment|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~During metformin treatment, individuals took 1700mg/day metformin in 2 doses for 6 weeks."
11234189|NCT02432287|OG001|Outcome|Placebo Treatment|During the placebo treatment, individuals took placebo capsules that matched metformin for 6 weeks.
11234190|NCT02432287|EG000|Reported Event|Metformin|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~Participants took metformin capsules 2 times daily for 6 weeks."
11234191|NCT02432287|EG001|Reported Event|Placebo|All participants took placebo capsules 2 x daily for 6 weeks.
10935283|NCT00734734|BG000|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
10935284|NCT00734734|FG000|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
11234192|NCT02432300|BG000|Baseline|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
11234193|NCT02432300|FG000|Participant Flow|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
11234194|NCT02432300|OG000|Outcome|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
11234195|NCT02432300|EG000|Reported Event|Treatment Group (Emotion Builder)|8 sessions of a web-based treatment, each lasting 60-90 minutes, twice per week over 4 weeks with a clinician research assistant. This treatment aimed to improve emotional awareness and labeling.
11234196|NCT02432456|BG000|Baseline|Placebo Infusion|Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
11234197|NCT02432456|BG001|Baseline|Ketamine Infusion|Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
11234198|NCT02432456|BG002|Baseline|Total|Total of all reporting groups
11234199|NCT02432456|FG000|Participant Flow|Placebo Infusion|Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
10935285|NCT00734734|OG000|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
10935286|NCT00734734|OG000|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
10935287|NCT00734734|EG000|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
10935288|NCT00734747|BG000|Baseline|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
10935289|NCT00734747|FG000|Participant Flow|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~Medigus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
10935290|NCT00734747|OG000|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
10935291|NCT00734747|EG000|Reported Event|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
10935292|NCT00734799|BG000|Baseline|Wait List|Usual Care/Wait-List Control
10935293|NCT00734799|BG001|Baseline|Intervention|Sleep Intervention for PTSD (SIP)
10935294|NCT00734799|BG002|Baseline|Total|Total of all reporting groups
10935295|NCT00734799|FG000|Participant Flow|Wait List|Usual Care/Wait-List Control
10935296|NCT00734799|FG001|Participant Flow|Intervention|Sleep Intervention for PTSD (SIP)
10935297|NCT00734799|OG000|Outcome|Wait List|Usual Care/Wait-List Control
10935298|NCT00734799|OG001|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
10935299|NCT00734799|EG000|Reported Event|Wait List|Usual Care/Wait-List Control
10935300|NCT00734799|EG001|Reported Event|Intervention|Sleep Intervention for PTSD (SIP)
10935301|NCT00734851|BG000|Baseline|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
10935302|NCT00734851|FG000|Participant Flow|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
10935303|NCT00734851|OG000|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
10935304|NCT00734851|EG000|Reported Event|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
10935305|NCT00734903|BG000|Baseline|A Woman's Path to Recovery (WPR)|A gender-focused approach to addiction recovery
10935306|NCT00734903|BG001|Baseline|12-Step Facilitation (TSF)|An evidence-based, non-gender-focused approach to addiction recovery
10935307|NCT00734903|BG002|Baseline|Total|Total of all reporting groups
10935308|NCT00734903|FG000|Participant Flow|A Woman's Path to Recovery (WPR)|A gender-focused approach to addiction recovery
10935309|NCT00734903|FG001|Participant Flow|12-Step Facilitation (TSF)|An evidence-based, non-gender-focused approach to addiction recovery
10935310|NCT00734903|OG000|Outcome|A Woman's Path to Recovery (WPR)|A gender-focused approach to addiction recovery
10935311|NCT00734903|OG001|Outcome|12-Step Facilitation (TSF)|An evidence-based, non-gender-focused approach to addiction recovery
10935312|NCT00734903|EG000|Reported Event|A Woman's Path to Recovery (WPR)|A gender-focused approach to addiction recovery
10935313|NCT00734903|EG001|Reported Event|12-Step Facilitation (TSF)|An evidence-based, non-gender-focused approach to addiction recovery
10935314|NCT00734929|BG000|Baseline|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
10935315|NCT00734929|BG001|Baseline|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
10935316|NCT00734929|BG002|Baseline|Total|Total of all reporting groups
10935317|NCT00734929|FG000|Participant Flow|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
10935318|NCT00734929|FG001|Participant Flow|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
10935319|NCT00734929|OG000|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
10935320|NCT00734929|OG001|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
10935321|NCT00734929|OG000|Outcome|Aprepitant + Dexamethasone|"Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia~Aprepitant + Dexamethasone: Aprepitant 40 mg + Dexamethasone 10 mg"
10935322|NCT00734929|OG001|Outcome|Ondansetron + Dexamethasone|"Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia~Ondansetron + Dexamethasone: Ondansetron 4 mg + Dexamethasone 10 mg"
10935323|NCT00734929|EG000|Reported Event|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
10935324|NCT00734929|EG001|Reported Event|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
10935325|NCT00734968|BG000|Baseline|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
10935326|NCT00734968|BG001|Baseline|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
10935327|NCT00734968|BG002|Baseline|Total|Total of all reporting groups
10935328|NCT00734968|FG000|Participant Flow|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO twice a day (BID) x 3 days post-operatively. The incidence of urinary tract infection (UTI) in this group will be compared with group one (1).~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100 mg tablets."
10935329|NCT00734968|FG001|Participant Flow|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
10935330|NCT00734968|OG000|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
10935331|NCT00734968|OG001|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
10935332|NCT00734968|EG000|Reported Event|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
10935333|NCT00734968|EG001|Reported Event|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
10935334|NCT00734994|BG000|Baseline|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
10935335|NCT00734994|FG000|Participant Flow|Mitomycin C With Hyperthermia and Recurrent Bladder Cancer|Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer
10935336|NCT00734994|OG000|Outcome|Hyperthermia System, Mitomycin C|"Pilot study single arm study to test the safety, tolerability and clinical benefit of regional hyperthermia and mitomycin-C intravesical chemotherapy to treat non-invasive Transitional Cell carcinoma (TCC) of the bladder that has recurred after standard resection and adjuvant therapy.~Hyperthermia System: Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence~Mitomycin C: 40 mg in 40 ml sterile water instilled into bladder"
10935337|NCT00734994|OG000|Outcome|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
10935338|NCT00734994|EG000|Reported Event|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
10935339|NCT00735007|BG000|Baseline|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
11234200|NCT02432456|FG001|Participant Flow|Ketamine Infusion|Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
10935340|NCT00735007|FG000|Participant Flow|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
10935341|NCT00735007|OG000|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
10935342|NCT00735007|EG000|Reported Event|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
10935343|NCT00735072|BG000|Baseline|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
10935344|NCT00735072|BG001|Baseline|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
10935345|NCT00735072|BG002|Baseline|Total|Total of all reporting groups
10935346|NCT00735072|FG000|Participant Flow|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
10935347|NCT00735072|FG001|Participant Flow|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
10935348|NCT00735072|OG000|Outcome|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
10935349|NCT00735072|OG001|Outcome|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
10935350|NCT00735072|OG000|Outcome|Maraviroc|"Maraviroc (dose based on current medications in regimen: 150mg orally (PO) twice daily (BID) for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).~Maraviroc: Dose based on current medications in regimen: 150mg orally (PO) twice daily (BID) for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens."
11234201|NCT02432456|OG000|Outcome|Placebo Infusion|Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
11234202|NCT02432456|OG001|Outcome|Ketamine Infusion|Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
11234203|NCT02432456|EG000|Reported Event|Placebo Infusion|Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
10935351|NCT00735072|OG001|Outcome|Placebo|"Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).~Placebo: Dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens."
10935352|NCT00735072|EG000|Reported Event|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
10935353|NCT00735072|EG001|Reported Event|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
10935354|NCT00735306|BG000|Baseline|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
10935355|NCT00735306|FG000|Participant Flow|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
10935356|NCT00735306|OG000|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
10935357|NCT00735306|OG000|Outcome|Single Arm Avastin, Tarceva and Radiation Therapy|"Avastin, Tarceva and Radiation Therapy~Avastin: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy~Tarceva: Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy~Radiation Therapy: Radiation to the pancreas Monday through Friday for 28 treatments"
10935358|NCT00735306|EG000|Reported Event|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
10935359|NCT00735371|BG000|Baseline|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
11176325|NCT02035267|FG002|Participant Flow|ATX-101 (Deoxycholic Acid) Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176326|NCT02035267|FG003|Participant Flow|Placebo Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176327|NCT02035267|OG000|Outcome|ATX-101 (Deoxycholic Acid) Injection - Grade 1|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176328|NCT02035267|OG001|Outcome|Placebo Injection - Grade 1|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10935360|NCT00735371|BG001|Baseline|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935361|NCT00735371|BG002|Baseline|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935362|NCT00735371|BG003|Baseline|Placebo|Placebo
10935363|NCT00735371|BG004|Baseline|Total|Total of all reporting groups
10935364|NCT00735371|FG000|Participant Flow|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
11176329|NCT02035267|OG002|Outcome|ATX-101 (Deoxycholic Acid) Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176330|NCT02035267|OG003|Outcome|Placebo Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176331|NCT02035267|OG000|Outcome|ATX-101 (Deoxycholic Acid) Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176332|NCT02035267|OG001|Outcome|Placebo Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176333|NCT02035267|EG000|Reported Event|ATX-101 (Deoxycholic Acid) Injection - Grade 1|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11192122|NCT02137369|OG000|Outcome|SSRI|"Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks, OR~Sertraline, [pill form, 50-150 mg, daily for 12 weeks"
10935365|NCT00735371|FG001|Participant Flow|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935366|NCT00735371|FG002|Participant Flow|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935367|NCT00735371|FG003|Participant Flow|Placebo|Placebo
10935368|NCT00735371|OG000|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935369|NCT00735371|OG001|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935370|NCT00735371|OG002|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935371|NCT00735371|OG003|Outcome|Placebo|Placebo
10935372|NCT00735371|EG000|Reported Event|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935373|NCT00735371|EG001|Reported Event|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935374|NCT00735371|EG002|Reported Event|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
10935375|NCT00735371|EG003|Reported Event|Placebo|Placebo
10935376|NCT00735397|BG000|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
10935377|NCT00735397|FG000|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
10935378|NCT00735397|OG000|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
10935379|NCT00735397|OG000|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
10935380|NCT00735397|OG001|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
10935381|NCT00735397|OG002|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
10935382|NCT00735397|EG000|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
10935383|NCT00735436|BG000|Baseline|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
10935384|NCT00735436|FG000|Participant Flow|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an enzyme-inducing anti-epileptic drugs (EIAED), the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
10935385|NCT00735436|OG000|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
10935386|NCT00735436|OG000|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
10935387|NCT00735436|EG000|Reported Event|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
10935388|NCT00735449|BG000|Baseline|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
10935389|NCT00735449|BG001|Baseline|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
10935390|NCT00735449|BG002|Baseline|Total|Total of all reporting groups
10935391|NCT00735449|FG000|Participant Flow|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
10935392|NCT00735449|FG001|Participant Flow|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
10935393|NCT00735449|OG000|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
10935394|NCT00735449|OG001|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
10935395|NCT00735449|EG000|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
10935396|NCT00735449|EG001|Reported Event|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
10935397|NCT00735462|BG000|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
10935398|NCT00735462|BG001|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
10935399|NCT00735462|BG002|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
10935400|NCT00735462|BG003|Baseline|Total|Total of all reporting groups
10935401|NCT00735462|FG000|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
10935402|NCT00735462|FG001|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
10935403|NCT00735462|FG002|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
10935404|NCT00735462|OG000|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
10935405|NCT00735462|OG001|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
10935406|NCT00735462|OG002|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
10935407|NCT00735462|EG000|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
10935408|NCT00735462|EG001|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
10935409|NCT00735462|EG002|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
10935410|NCT00735475|BG000|Baseline|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
10935411|NCT00735475|BG001|Baseline|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
10935412|NCT00735475|BG002|Baseline|Total|Total of all reporting groups
10935413|NCT00735475|FG000|Participant Flow|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
10935414|NCT00735475|FG001|Participant Flow|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
10935415|NCT00735475|OG000|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
10935416|NCT00735475|OG001|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
10935417|NCT00735475|EG000|Reported Event|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
10935418|NCT00735475|EG001|Reported Event|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
10935419|NCT00735618|BG000|Baseline|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
10935420|NCT00735618|FG000|Participant Flow|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
10935421|NCT00735618|OG000|Outcome|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program and summed ESAS scores
10935422|NCT00735618|EG000|Reported Event|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
10935423|NCT00735644|BG000|Baseline|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
10935424|NCT00735644|BG001|Baseline|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
10935425|NCT00735644|BG002|Baseline|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
10935426|NCT00735644|BG003|Baseline|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
10935427|NCT00735644|BG004|Baseline|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
10935428|NCT00735644|BG005|Baseline|Total|Total of all reporting groups
10935429|NCT00735644|FG000|Participant Flow|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.
10935430|NCT00735644|FG001|Participant Flow|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
10935431|NCT00735644|FG002|Participant Flow|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3
10935432|NCT00735644|FG003|Participant Flow|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
10935433|NCT00735644|FG004|Participant Flow|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis A vaccine
10935434|NCT00735644|OG000|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
10935435|NCT00735644|OG001|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
10935436|NCT00735644|OG002|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
10935437|NCT00735644|OG003|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
10935438|NCT00735644|OG004|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
11192123|NCT02137369|OG001|Outcome|Cognitive Behavioral Therapy|"Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided over 12 weeks.~Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks."
10935439|NCT00735644|OG000|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
11234204|NCT02432456|EG001|Reported Event|Ketamine Infusion|Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
11240691|NCT02481219|OG000|Outcome|Bowel Preparation Regimen - Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
11240692|NCT02481219|OG001|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure- Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
11240693|NCT02481219|OG000|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure- Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
11240694|NCT02481219|EG000|Reported Event|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
11240695|NCT02481219|EG001|Reported Event|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
11240696|NCT02481258|BG000|Baseline|Ataciguat (HMR1766)|"200mg taken daily for 12 months~Ataciguat (HMR1766)"
11240697|NCT02481258|BG001|Baseline|Matching Placebo|"Taken Daily for 12 months~Placebo Comparator: Matching Placebo"
11240698|NCT02481258|BG002|Baseline|Total|Total of all reporting groups
11240699|NCT02481258|FG000|Participant Flow|Ataciguat (HMR1766)|"200mg taken daily for 6 months~Ataciguat (HMR1766)"
11240700|NCT02481258|FG001|Participant Flow|Matching Placebo|"Taken Daily for 6 months~Placebo Comparator: Matching Placebo"
11240701|NCT02481258|OG000|Outcome|Ataciguat (HMR1766)|"200mg taken daily for 12 months~Ataciguat (HMR1766)"
11240702|NCT02481258|OG001|Outcome|Matching Placebo|"Taken Daily for 12 months~Placebo Comparator: Matching Placebo"
11240703|NCT02481258|OG000|Outcome|Ataciguat (HMR1766)|"200mg taken daily for 6 months~Ataciguat (HMR1766)"
11240704|NCT02481258|OG001|Outcome|Matching Placebo|"Taken Daily for 6 months~Placebo Comparator: Matching Placebo"
10935440|NCT00735644|OG000|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
10935441|NCT00735644|OG001|Outcome|JE-CV MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 2 subcutaneously
10935442|NCT00735644|OG002|Outcome|JE-CV MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 3 subcutaneously
10935443|NCT00735644|OG003|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE CV from Acambis at WRAIR subcutaneously
11240705|NCT02481258|EG000|Reported Event|Ataciguat (HMR1766)|"200mg taken daily for 6 months~Ataciguat (HMR1766)"
11240706|NCT02481258|EG001|Reported Event|Matching Placebo|"Taken Daily for 6 months~Placebo Comparator: Matching Placebo"
11240707|NCT02481297|BG000|Baseline|Cohort 1: Refractory/Relapsed After Prior Therapy|"Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12."
11240708|NCT02481297|BG001|Baseline|Cohort 2: Untreated With High-rRisk mMolecular Features|"Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12."
11240709|NCT02481297|BG002|Baseline|Total|Total of all reporting groups
11240710|NCT02481297|FG000|Participant Flow|Cohort 1: Refractory/Relapsed After Prior Therapy|"Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12."
10935444|NCT00735644|OG004|Outcome|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis vaccine intramuscularly
10935445|NCT00735644|OG000|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
10935446|NCT00735644|EG000|Reported Event|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
10935447|NCT00735644|EG001|Reported Event|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
10935448|NCT00735644|EG002|Reported Event|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
10935449|NCT00735644|EG003|Reported Event|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
10935450|NCT00735644|EG004|Reported Event|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
10935451|NCT00735670|BG000|Baseline|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
10935452|NCT00735670|BG001|Baseline|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
10935453|NCT00735670|BG002|Baseline|Total|Total of all reporting groups
10935454|NCT00735670|FG000|Participant Flow|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
10935455|NCT00735670|FG001|Participant Flow|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
10935456|NCT00735670|OG000|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
11176334|NCT02035267|EG001|Reported Event|Placebo Injection - Grade 1|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176335|NCT02035267|EG002|Reported Event|ATX-101 (Deoxycholic Acid) Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
10935457|NCT00735670|OG001|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
10935458|NCT00735670|EG000|Reported Event|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
10935459|NCT00735670|EG001|Reported Event|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
10935460|NCT00735696|BG000|Baseline|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks."
10935461|NCT00735696|FG000|Participant Flow|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
10935462|NCT00735696|OG000|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
10935463|NCT00735696|EG000|Reported Event|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
10935464|NCT00735709|BG000|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10935465|NCT00735709|BG001|Baseline|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
11176336|NCT02035267|EG003|Reported Event|Placebo Injection - Grade 4|Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11176337|NCT02035332|BG000|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
11176338|NCT02035332|FG000|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
11176339|NCT02035332|OG000|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
11176340|NCT02035332|EG000|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
11176341|NCT02035345|BG000|Baseline|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
11176342|NCT02035345|FG000|Participant Flow|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
11176343|NCT02035345|OG000|Outcome|Carboplain Slowed Infusion Group Reactors|Patients that received carboplatin via slowed infusion that developed a reaction
11176344|NCT02035345|OG000|Outcome|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
11176345|NCT02035345|EG000|Reported Event|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
11176346|NCT02035475|BG000|Baseline|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
11176347|NCT02035475|FG000|Participant Flow|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
11176348|NCT02035475|OG000|Outcome|EndoWrist 1 Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side."
11176349|NCT02035475|OG001|Outcome|Fenestrated Maryland BiPolar Instrument|The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.
11176350|NCT02035475|OG000|Outcome|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
11176351|NCT02035475|EG000|Reported Event|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
11176352|NCT02035553|BG000|Baseline|Placebo|Placebo, two tablets, once daily by mouth
11176353|NCT02035553|BG001|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
11176354|NCT02035553|BG002|Baseline|Total|Total of all reporting groups
10935466|NCT00735709|BG002|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935467|NCT00735709|BG003|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935468|NCT00735709|BG004|Baseline|Total|Total of all reporting groups
10935469|NCT00735709|FG000|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10935470|NCT00735709|FG001|Participant Flow|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935471|NCT00735709|FG002|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935472|NCT00735709|FG003|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935473|NCT00735709|OG000|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10935474|NCT00735709|OG001|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935475|NCT00735709|OG002|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935476|NCT00735709|OG003|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935477|NCT00735709|EG000|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10935478|NCT00735709|EG001|Reported Event|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935479|NCT00735709|EG002|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935480|NCT00735709|EG003|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
10935481|NCT00735787|BG000|Baseline|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
10935482|NCT00735787|BG001|Baseline|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
10935483|NCT00735787|BG002|Baseline|Total|Total of all reporting groups
10935484|NCT00735787|FG000|Participant Flow|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
10935485|NCT00735787|FG001|Participant Flow|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
10935486|NCT00735787|OG000|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
10935487|NCT00735787|OG001|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
10935488|NCT00735787|EG000|Reported Event|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
10935489|NCT00735787|EG001|Reported Event|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
10935490|NCT00735826|BG000|Baseline|Vorinostat|Vorinostat group
10935491|NCT00735826|FG000|Participant Flow|Vorinostat|Vorinostat 400mg one daily administered orally for 7 to 10 days prior to a second biopsy/ thoracotomy.
10935492|NCT00735826|OG000|Outcome|Vorinostat|Vorinostat 400 mg once daily orally for 7 to 10 days prior to a second biopsy/ thoracotomy.
10935493|NCT00735826|OG000|Outcome|Vorinostat Intratumoral Concentrations|Vorinostat 400mg one daily administered orally for 7 days prior to a second biopsy/ thoracotomy.
10935494|NCT00735826|OG000|Outcome|Necrosis|Vorinostat 400mg one daily administered orally for 7 days prior to a second biopsy/ thoracotomy.
10935495|NCT00735826|EG000|Reported Event|Vorinostat|Vorinostat group
10935496|NCT00735839|BG000|Baseline|V710|V710 vaccination (60 mcg) single dose on Day 1
10935497|NCT00735839|BG001|Baseline|Placebo|Placebo single dose on Day 1
10935498|NCT00735839|BG002|Baseline|Total|Total of all reporting groups
11176355|NCT02035553|FG000|Participant Flow|Placebo|Placebo, two tablets, once daily by mouth
11176356|NCT02035553|FG001|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
11176357|NCT02035553|OG000|Outcome|Placebo|Placebo, two tablets, once daily by mouth
11176358|NCT02035553|OG001|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
10935499|NCT00735839|FG000|Participant Flow|V710|V710 vaccination (60 mcg) single dose on Day 1
10935500|NCT00735839|FG001|Participant Flow|Placebo|Placebo single dose on Day 1
10935501|NCT00735839|OG000|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
10935502|NCT00735839|OG001|Outcome|Placebo|Placebo single dose on Day 1
10935503|NCT00735839|EG000|Reported Event|V710|V710 vaccination (60 mcg) single dose on Day 1
10935504|NCT00735839|EG001|Reported Event|Placebo|Placebo single dose on Day 1
10935505|NCT00735878|BG000|Baseline|100 mg|Maximum Tolerated Dose Determination Phase
10935506|NCT00735878|BG001|Baseline|125 mg|Maximum Tolerated Dose Determination Phase
10935507|NCT00735878|BG002|Baseline|150 mg|Maximum Tolerated Dose Determination Phase
10935508|NCT00735878|BG003|Baseline|Total|Total of all reporting groups
10935509|NCT00735878|FG000|Participant Flow|100 mg|Maximum Tolerated Dose Determination Phase
10935510|NCT00735878|FG001|Participant Flow|125 mg|Maximum Tolerated Dose Determination Phase
10935511|NCT00735878|FG002|Participant Flow|150 mg|Maximum Tolerated Dose Determination Phase
10935512|NCT00735878|OG000|Outcome|Group 1/ Dose Escalating ABT-751 in Combination With Carboplat|Oral dose escalating of ABT-871 given BID on Day 1 of each cycle for 7 days in combination with Carboplatin given on a 21-day schedule. There will be up to 7 Cohorts(Dose Levels) from 100 to 200 mg/m2 of ABT-751 mg BID with Carboplatin AUC 4.5 for the first two cohorts, and AUC 6 for the remaining.
11176359|NCT02035553|EG000|Reported Event|Placebo|Placebo, two tablets, once daily by mouth
11176360|NCT02035553|EG001|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
11176361|NCT02035696|BG000|Baseline|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
11176362|NCT02035696|BG001|Baseline|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
10851548|NCT00306995|FG002|Participant Flow|SB218352_4 Group:|Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851549|NCT00306995|FG003|Participant Flow|SB218352_2 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851550|NCT00306995|FG004|Participant Flow|SB218352_8AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851551|NCT00306995|FG005|Participant Flow|SB218352_4AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851552|NCT00306995|FG006|Participant Flow|SB218352_2AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
10851553|NCT00306995|OG000|Outcome|SB218352_15 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851554|NCT00306995|OG001|Outcome|SB218352_8 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851555|NCT00306995|OG002|Outcome|SB218352_4 Group:|Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851556|NCT00306995|OG003|Outcome|SB218352_2 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851557|NCT00306995|OG004|Outcome|SB218352_8AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851558|NCT00306995|OG005|Outcome|SB218352_4AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851559|NCT00306995|OG006|Outcome|SB218352_2AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851560|NCT00306995|OG000|Outcome|SB218352_15 Subset 1|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
10851561|NCT00306995|OG001|Outcome|SB218352_8 Subset 1|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
10851562|NCT00306995|OG002|Outcome|SB218352_4 Subset 1|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
10851563|NCT00306995|OG003|Outcome|SB218352_2 Subset 1|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
10851564|NCT00306995|OG004|Outcome|SB218352_8AL Subset 1|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
10851565|NCT00306995|OG005|Outcome|SB218352_4AL Subset 1|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
10935513|NCT00735878|OG000|Outcome|Group 1/ Dose Escalating ABT-751 in Combination With Carboplat|Oral dose escalating of ABT-871 given BID on Day 1 of each cycle for 7 days in combination with Carboplatin given on a 21-day schedule. There will be up to 7 Cohorts(Dose Levels) from 100 t0 200 mg/m2 of ABT-751 mg BID
10935514|NCT00735878|OG000|Outcome|All Participants Treated at MTD|Median overall survival of all patients (Ph I and Ph II) treated at MTD.
10935515|NCT00735878|OG000|Outcome|Group 1/ Dose Escalating ABT-751 in Combination With Carboplat|Oral dose escalating of ABT-871 given BID on Day 1 of each cycle for 7 days in combination with Carboplatin given on a 21-day schedule. There will be up to 7 Cohorts(Dose Levels) from 100 to 200 mg/m2 of ABT-751 mg BID
10935516|NCT00735878|OG001|Outcome|Group 2/ Phase II|Phase 2 participants treated at MTD.
10935517|NCT00735878|OG000|Outcome|Phase II/Group 2|Number of participants evaluated for buccal mucosa cells
10935518|NCT00735878|EG000|Reported Event|100 mg|Maximum Tolerated Dose Determination Phase
10935519|NCT00735878|EG001|Reported Event|125 mg|Maximum Tolerated Dose Determination Phase
10935520|NCT00735878|EG002|Reported Event|150 mg|Maximum Tolerated Dose Determination Phase
10935521|NCT00735904|BG000|Baseline|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
10935522|NCT00735904|FG000|Participant Flow|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
10935523|NCT00735904|OG000|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
10935524|NCT00735904|EG000|Reported Event|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
10935525|NCT00735917|BG000|Baseline|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
10935526|NCT00735917|FG000|Participant Flow|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
10935527|NCT00735917|OG000|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
10935528|NCT00735917|EG000|Reported Event|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
10935529|NCT00735943|BG000|Baseline|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
10935530|NCT00735943|FG000|Participant Flow|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
10935531|NCT00735943|OG000|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
10935532|NCT00735943|EG000|Reported Event|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
10935533|NCT00735969|BG000|Baseline|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
10935534|NCT00735969|FG000|Participant Flow|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and assigned to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
10935535|NCT00735969|OG000|Outcome|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
10935536|NCT00735969|EG000|Reported Event|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
10935537|NCT00736034|BG000|Baseline|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
10935538|NCT00736034|FG000|Participant Flow|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
10935539|NCT00736034|OG000|Outcome|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
10935540|NCT00736034|EG000|Reported Event|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
10935541|NCT00736073|BG000|Baseline|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935542|NCT00736073|BG001|Baseline|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935543|NCT00736073|BG002|Baseline|Total|Total of all reporting groups
10935544|NCT00736073|FG000|Participant Flow|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935545|NCT00736073|FG001|Participant Flow|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935546|NCT00736073|OG000|Outcome|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935547|NCT00736073|OG001|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935548|NCT00736073|OG000|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935549|NCT00736073|EG000|Reported Event|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935550|NCT00736073|EG001|Reported Event|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
10935551|NCT00736099|BG000|Baseline|Old Lina|Patients pre-treated with linagliptin
10935552|NCT00736099|BG001|Baseline|New Lina|Patients pre-treated with placebo
10935553|NCT00736099|BG002|Baseline|Total|Total of all reporting groups
10935554|NCT00736099|FG000|Participant Flow|Old Lina|Patients pre-treated with linagliptin (BI 1356)
10935555|NCT00736099|FG001|Participant Flow|New Lina|Patients pre-treated with placebo
10935556|NCT00736099|OG000|Outcome|Old Lina|Patients pre-treated with linagliptin
10935557|NCT00736099|OG001|Outcome|New Lina|Patients pre-treated with placebo
10935558|NCT00736099|EG000|Reported Event|Old Lina|Patients pre-treated with linagliptin
10935559|NCT00736099|EG001|Reported Event|New Lina|Patients pre-treated with placebo
10935560|NCT00736125|BG000|Baseline|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
10935561|NCT00736125|BG001|Baseline|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
10935562|NCT00736125|BG002|Baseline|Total|Total of all reporting groups
10935563|NCT00736125|FG000|Participant Flow|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
10935564|NCT00736125|FG001|Participant Flow|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
10935565|NCT00736125|OG000|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
10935566|NCT00736125|OG001|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
10935567|NCT00736125|EG000|Reported Event|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
10935568|NCT00736125|EG001|Reported Event|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
10935569|NCT00736190|BG000|Baseline|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
10935570|NCT00736190|FG000|Participant Flow|A: TDF|Tenofovir disoproxil fumarate (TDF) 300 mg by mouth daily
10935571|NCT00736190|OG000|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
10935572|NCT00736190|EG000|Reported Event|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
10935573|NCT00736229|BG000|Baseline|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
10935574|NCT00736229|BG001|Baseline|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
10935575|NCT00736229|BG002|Baseline|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
10935576|NCT00736229|BG003|Baseline|Total|Total of all reporting groups
10935577|NCT00736229|FG000|Participant Flow|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
10935578|NCT00736229|FG001|Participant Flow|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
11176363|NCT02035696|BG002|Baseline|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
11176364|NCT02035696|BG003|Baseline|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
10935579|NCT00736229|FG002|Participant Flow|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
10935580|NCT00736229|OG000|Outcome|Exenatide|Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.
10935581|NCT00736229|OG001|Outcome|Moderate|In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
10935582|NCT00736229|OG002|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
10935583|NCT00736229|OG000|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
10935584|NCT00736229|OG001|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
10935585|NCT00736229|OG002|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
10935586|NCT00736229|EG000|Reported Event|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
10935587|NCT00736242|BG000|Baseline|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
10935588|NCT00736242|FG000|Participant Flow|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus ribavirin (RBV) according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
10935589|NCT00736242|OG000|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
10935590|NCT00736242|EG000|Reported Event|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
10935591|NCT00736255|BG000|Baseline|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
10935592|NCT00736255|BG001|Baseline|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
10935593|NCT00736255|BG002|Baseline|Total|Total of all reporting groups
10935594|NCT00736255|FG000|Participant Flow|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
10935595|NCT00736255|FG001|Participant Flow|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
10935596|NCT00736255|OG000|Outcome|LDX and NRT|"• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.~Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch: Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week."
10935597|NCT00736255|OG001|Outcome|NRT and Placebo|"The second group will receive matching placebo and NRT after the quit date.~Placebo and transdermal nicotine patch: Subjects on this arm will receive matching placebo and NRT."
10935598|NCT00736255|EG000|Reported Event|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
10935599|NCT00736255|EG001|Reported Event|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
10935600|NCT00736333|BG000|Baseline|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
10935601|NCT00736333|FG000|Participant Flow|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
10935602|NCT00736333|OG000|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
10935603|NCT00736333|EG000|Reported Event|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
10935604|NCT00736450|BG000|Baseline|Arm I|"Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).~oblimersen sodium: Given IV~rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV~prednisone: Given orally"
10935605|NCT00736450|FG000|Participant Flow|Arm I|"Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).~oblimersen sodium: Given IV~rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV~prednisone: Given orally"
10935606|NCT00736450|OG000|Outcome|Arm I|"Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).~oblimersen sodium: Given IV~rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV~prednisone: Given orally"
10935607|NCT00736450|EG000|Reported Event|Arm I|"Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).~oblimersen sodium: Given IV~rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV~prednisone: Given orally"
10935608|NCT00736476|BG000|Baseline|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
10935609|NCT00736476|BG001|Baseline|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months
10935610|NCT00736476|BG002|Baseline|Total|Total of all reporting groups
10935611|NCT00736476|FG000|Participant Flow|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months, followed by H.pylori challenge(oral administration of infectious HP inoculum)1 month later.
10935612|NCT00736476|FG001|Participant Flow|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months,followed by H.pylori challenge (oral administration of infectious HP inoculum)1 month later.
10935613|NCT00736476|OG000|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
10935614|NCT00736476|OG001|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
11176365|NCT02035696|BG004|Baseline|Total|Total of all reporting groups
11176366|NCT02035696|FG000|Participant Flow|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
10935615|NCT00736476|OG000|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
10935616|NCT00736476|OG001|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
10935617|NCT00736476|OG000|Outcome|Group I (HP Vaccine) Infected|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
10935618|NCT00736476|OG001|Outcome|Group I (HP Vaccine) Non-Infected|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
10935619|NCT00736476|OG002|Outcome|Group II (Placebo) Infected|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
10935620|NCT00736476|OG003|Outcome|Group II (Placebo) Non-Infected|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
10935621|NCT00736476|EG000|Reported Event|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
10935622|NCT00736476|EG001|Reported Event|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months
10935623|NCT00736489|BG000|Baseline|Baseline Total|Total number of patients randomized and treated in the study
10935624|NCT00736489|FG000|Participant Flow|APCDEBa|AZD3199 120 Mcg followed by Placebo followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg.
10935625|NCT00736489|FG001|Participant Flow|BADEPCa|AZD3199 480 Mcg followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 1920 Mcg.
10935626|NCT00736489|FG002|Participant Flow|CBEPADa|AZD3199 1920 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg .
10935627|NCT00736489|FG003|Participant Flow|DCPABEa|Formoterol 9 Mcg followed by AZD3199 1920 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg.
10935628|NCT00736489|FG004|Participant Flow|EDABCPa|Formoterol 36 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Placebo.
10935629|NCT00736489|FG005|Participant Flow|PEBCDAa|Placebo followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg.
10935630|NCT00736489|OG000|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
10935631|NCT00736489|OG001|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
10935632|NCT00736489|OG002|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
10935633|NCT00736489|OG003|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
10935634|NCT00736489|OG004|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
10935635|NCT00736489|OG005|Outcome|Placebo|Placebo inhaled via Turbuhaler
10935636|NCT00736489|EG000|Reported Event|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
10935637|NCT00736489|EG001|Reported Event|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
10935638|NCT00736489|EG002|Reported Event|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
10935639|NCT00736489|EG003|Reported Event|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
10935640|NCT00736489|EG004|Reported Event|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
10935641|NCT00736489|EG005|Reported Event|Placebo|Placebo inhaled via Turbuhaler
10935642|NCT00736502|BG000|Baseline|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
10935643|NCT00736502|FG000|Participant Flow|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
10935644|NCT00736502|OG000|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
10935645|NCT00736502|EG000|Reported Event|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
10935646|NCT00736580|BG000|Baseline|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
10935647|NCT00736580|BG001|Baseline|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
10935648|NCT00736580|BG002|Baseline|Total|Total of all reporting groups
10935649|NCT00736580|FG000|Participant Flow|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
10935650|NCT00736580|FG001|Participant Flow|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
10935651|NCT00736580|OG000|Outcome|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
10935652|NCT00736580|OG001|Outcome|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
10935653|NCT00736580|EG000|Reported Event|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
10935654|NCT00736580|EG001|Reported Event|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
10935655|NCT00736632|BG000|Baseline|Placebo|"Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.~Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily"
10935656|NCT00736632|BG001|Baseline|Vitamin D|"Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.~Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily"
10935657|NCT00736632|BG002|Baseline|Non-intervention Blood Collection|Patients received no intervention. This is a one-time blood collection only.
10935658|NCT00736632|BG003|Baseline|Total|Total of all reporting groups
10935659|NCT00736632|FG000|Participant Flow|Placebo|"Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.~Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily"
10935660|NCT00736632|FG001|Participant Flow|Vitamin D|"Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.~Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily"
10935661|NCT00736632|FG002|Participant Flow|Non-Intervention Blood Collection|Subjects without intervention will give a one-time blood sample for analysis of monocytes.
10935662|NCT00736632|OG000|Outcome|Placebo|"Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.~Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily"
10935663|NCT00736632|OG001|Outcome|Vitamin D|"Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.~Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily"
10935664|NCT00736632|EG000|Reported Event|Placebo|"Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.~Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily"
10935665|NCT00736632|EG001|Reported Event|Vitamin D|"Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.~Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily"
10935666|NCT00736645|BG000|Baseline|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
10935667|NCT00736645|BG001|Baseline|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
10935668|NCT00736645|BG002|Baseline|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
10935669|NCT00736645|BG003|Baseline|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
10935670|NCT00736645|BG004|Baseline|Total|Total of all reporting groups
10935671|NCT00736645|FG000|Participant Flow|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
10935672|NCT00736645|FG001|Participant Flow|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
10935673|NCT00736645|FG002|Participant Flow|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
10935674|NCT00736645|FG003|Participant Flow|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
11176367|NCT02035696|FG001|Participant Flow|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
11176368|NCT02035696|FG002|Participant Flow|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
11176369|NCT02035696|FG003|Participant Flow|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
10935675|NCT00736645|OG000|Outcome|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
10935676|NCT00736645|OG001|Outcome|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
10935677|NCT00736645|OG002|Outcome|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
10935678|NCT00736645|OG003|Outcome|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
10935679|NCT00736645|EG000|Reported Event|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
10935680|NCT00736645|EG001|Reported Event|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
10935681|NCT00736645|EG002|Reported Event|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
10935682|NCT00736645|EG003|Reported Event|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
10935683|NCT00736723|BG000|Baseline|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
10935684|NCT00736723|BG001|Baseline|Postoperative/Posttraumatic Patients With Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
10935685|NCT00736723|BG002|Baseline|Total|Total of all reporting groups
10935686|NCT00736723|FG000|Participant Flow|Patients With Non-septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing non-septic shock
10935687|NCT00736723|FG001|Participant Flow|Patients With Septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock
10935688|NCT00736723|OG000|Outcome|Patients Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
10935689|NCT00736723|OG001|Outcome|Patients Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
10935690|NCT00736723|EG000|Reported Event|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
10935691|NCT00736723|EG001|Reported Event|Postoperative/Posttraumatic Patients With Septi|Postoperative/posttraumatic critically ill patients with septic shock
10935692|NCT00736840|BG000|Baseline|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
11176370|NCT02035696|OG000|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
11176371|NCT02035696|OG001|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
11176372|NCT02035696|OG002|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
11176373|NCT02035696|OG003|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
11176374|NCT02035696|OG000|Outcome|TIVc-High Dose-TIVe|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
11176375|NCT02035696|OG001|Outcome|TIVc-Full Dose-TIVe|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
11176376|NCT02035696|OG002|Outcome|TIVc- Half Dose-TIVe|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
11176377|NCT02035696|EG000|Reported Event|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
10935693|NCT00736840|FG000|Participant Flow|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
10935694|NCT00736840|OG000|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
10935695|NCT00736840|EG000|Reported Event|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
10935696|NCT00736853|BG000|Baseline|Entire Study Population|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets) during the open-label period. Participants received placebo or fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg (same dose which was used in second week of open-label period) in double-blind period.
10935697|NCT00736853|FG000|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
10935698|NCT00736853|FG001|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
10935699|NCT00736853|FG002|Participant Flow|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
10935700|NCT00736853|OG000|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
10935701|NCT00736853|OG001|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
10935702|NCT00736853|OG000|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
11176378|NCT02035696|EG001|Reported Event|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
11176379|NCT02035696|EG002|Reported Event|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
11176380|NCT02035696|EG003|Reported Event|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
11176381|NCT02035696|EG004|Reported Event|Total|Total number of subjects
11176382|NCT02035748|BG000|Baseline|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
11176383|NCT02035748|FG000|Participant Flow|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
11176384|NCT02035748|OG000|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
11176385|NCT02035748|EG000|Reported Event|Pretreatment|All subjects consented to participate in the study prior to the initiation of study treatment
11176386|NCT02035748|EG001|Reported Event|Ocriplasmin|All subjects exposed to the investigational product
11176387|NCT02036294|BG000|Baseline|Usual Care|"Usual Care: Standard healthcare services will be received. Study participants in this arm will not receive any additional study interventions.~Usual Care: Standard Healthcare Services"
11176388|NCT02036294|BG001|Baseline|BREATHE Program|"Study participants randomized to this arm will be offered the BREATHE program an integrated multifaceted intervention that includes comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services .~BREATHE program: A patient and family- centered transitional care intervention that includes a comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services ."
11176389|NCT02036294|BG002|Baseline|Total|Total of all reporting groups
10935703|NCT00736853|OG000|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
10935704|NCT00736853|EG000|Reported Event|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
10935705|NCT00736853|EG001|Reported Event|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
10935706|NCT00736853|EG002|Reported Event|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
10935707|NCT00736879|BG000|Baseline|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935708|NCT00736879|BG001|Baseline|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935709|NCT00736879|BG002|Baseline|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
11176390|NCT02036294|FG000|Participant Flow|Usual Care|"Usual Care: Standard healthcare services will be received. Study participants in this arm will not receive any additional study interventions.~Usual Care: Standard Healthcare Services"
11176391|NCT02036294|FG001|Participant Flow|BREATHE Program|"Study participants randomized to this arm will be offered the BREATHE program an integrated multifaceted intervention that includes comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services .~BREATHE program: A patient and family- centered transitional care intervention that includes a comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services ."
11176392|NCT02036294|OG000|Outcome|Usual Care|"Usual Care: Standard healthcare services will be received. Study participants in this arm will not receive any additional study interventions.~Usual Care: Standard Healthcare Services"
11176393|NCT02036294|OG001|Outcome|BREATHE Program|"Study participants randomized to this arm will be offered the BREATHE program an integrated multifaceted intervention that includes comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services .~BREATHE program: A patient and family- centered transitional care intervention that includes a comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services ."
11176394|NCT02036294|EG000|Reported Event|Usual Care|"Usual Care: Standard healthcare services will be received. Study participants in this arm will not receive any additional study interventions.~Usual Care: Standard Healthcare Services"
11176395|NCT02036294|EG001|Reported Event|BREATHE Program|"Study participants randomized to this arm will be offered the BREATHE program an integrated multifaceted intervention that includes comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services .~BREATHE program: A patient and family- centered transitional care intervention that includes a comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services ."
11176396|NCT02036320|BG000|Baseline|Overall|All subjects that were dispensed a test article during the study.
11176397|NCT02036320|FG000|Participant Flow|Test 1/Test 2|Subjects who received test lens 1 first and then received test lens 2.
11176398|NCT02036320|FG001|Participant Flow|Test 2/Test 1|Subjects who received test lens 2 first and then received test lens 1.
10935710|NCT00736879|BG003|Baseline|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935711|NCT00736879|BG004|Baseline|Total|Total of all reporting groups
10935712|NCT00736879|FG000|Participant Flow|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935713|NCT00736879|FG001|Participant Flow|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935714|NCT00736879|FG002|Participant Flow|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935715|NCT00736879|FG003|Participant Flow|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935716|NCT00736879|OG000|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935717|NCT00736879|OG001|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935718|NCT00736879|OG002|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935719|NCT00736879|OG003|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935720|NCT00736879|OG001|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
11176399|NCT02036320|OG000|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
11176400|NCT02036320|OG001|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
11176401|NCT02036320|EG000|Reported Event|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
10935721|NCT00736879|OG002|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935722|NCT00736879|OG003|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935723|NCT00736879|EG000|Reported Event|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935724|NCT00736879|EG001|Reported Event|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935725|NCT00736879|EG002|Reported Event|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935726|NCT00736879|EG003|Reported Event|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
10935727|NCT00736944|BG000|Baseline|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
10935728|NCT00736944|FG000|Participant Flow|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
10935729|NCT00736944|OG000|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
10935730|NCT00736944|OG000|Outcome|Clinical Examination|
10935731|NCT00736944|OG001|Outcome|CT Scan|
10935732|NCT00736944|OG002|Outcome|FDG-PET/CT|
11176402|NCT02036320|EG001|Reported Event|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
11176403|NCT02036424|BG000|Baseline|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
11176404|NCT02036424|BG001|Baseline|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
11176405|NCT02036424|BG002|Baseline|Total|Total of all reporting groups
11176406|NCT02036424|FG000|Participant Flow|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
10935733|NCT00736944|EG000|Reported Event|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
10935734|NCT00736957|BG000|Baseline|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
10935735|NCT00736957|FG000|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
10935736|NCT00736957|OG000|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
10935737|NCT00736957|EG000|Reported Event|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
10935738|NCT00736996|BG000|Baseline|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
10935739|NCT00736996|BG001|Baseline|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
10935740|NCT00736996|BG002|Baseline|Placebo|Placebo: Matching oral tablet daily for 6 months
10935741|NCT00736996|BG003|Baseline|Total|Total of all reporting groups
10935742|NCT00736996|FG000|Participant Flow|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
10935743|NCT00736996|FG001|Participant Flow|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
10935744|NCT00736996|FG002|Participant Flow|Placebo|Placebo: Matching oral tablet daily for 6 months
10935745|NCT00736996|OG000|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
10935746|NCT00736996|OG001|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
10935747|NCT00736996|OG002|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
10935748|NCT00736996|EG000|Reported Event|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
11176407|NCT02036424|FG001|Participant Flow|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
11176408|NCT02036424|OG000|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
10935749|NCT00736996|EG001|Reported Event|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
10935750|NCT00736996|EG002|Reported Event|Placebo|Placebo: Matching oral tablet daily for 6 months
10935751|NCT00737048|BG000|Baseline|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935752|NCT00737048|BG001|Baseline|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935753|NCT00737048|BG002|Baseline|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935754|NCT00737048|BG003|Baseline|Total|Total of all reporting groups
10935755|NCT00737048|FG000|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
11176409|NCT02036424|OG001|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
10935756|NCT00737048|FG001|Participant Flow|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935757|NCT00737048|FG002|Participant Flow|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935758|NCT00737048|OG000|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935759|NCT00737048|OG001|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935760|NCT00737048|OG002|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935761|NCT00737048|EG000|Reported Event|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935762|NCT00737048|EG001|Reported Event|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935763|NCT00737048|EG002|Reported Event|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
10935764|NCT00737061|BG000|Baseline|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
10935765|NCT00737061|FG000|Participant Flow|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
10935766|NCT00737061|OG000|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
11176410|NCT02036424|EG000|Reported Event|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
10935767|NCT00737061|EG000|Reported Event|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
10935768|NCT00737100|BG000|Baseline|Placebo|Patients randomised to receive matching placebo
10935769|NCT00737100|BG001|Baseline|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
10935770|NCT00737100|BG002|Baseline|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
10935771|NCT00737100|BG003|Baseline|Total|Total of all reporting groups
10935772|NCT00737100|FG000|Participant Flow|Placebo|Patients randomised to receive matching placebo
10935773|NCT00737100|FG001|Participant Flow|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
10935774|NCT00737100|FG002|Participant Flow|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
10935775|NCT00737100|OG000|Outcome|Placebo|Patients randomised to receive matching placebo
10935776|NCT00737100|OG001|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
10935777|NCT00737100|OG002|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
10935778|NCT00737100|OG000|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
10935779|NCT00737100|OG001|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
10935780|NCT00737100|EG000|Reported Event|Placebo|Patients randomised to receive matching placebo
10935781|NCT00737100|EG001|Reported Event|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
10935782|NCT00737100|EG002|Reported Event|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
10935783|NCT00737178|BG000|Baseline|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
10935784|NCT00737178|BG001|Baseline|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
10935785|NCT00737178|BG002|Baseline|Total|Total of all reporting groups
10935786|NCT00737178|FG000|Participant Flow|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
10935787|NCT00737178|FG001|Participant Flow|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
11176411|NCT02036424|EG001|Reported Event|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
11192124|NCT02137369|OG000|Outcome|SSRI|Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks, OR Sertraline, pill form, 50-150 mg, daily, for 12 weeks
10935788|NCT00737178|OG000|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
10935789|NCT00737178|OG001|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
10935790|NCT00737178|EG000|Reported Event|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
10935791|NCT00737178|EG001|Reported Event|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
10935792|NCT00737204|BG000|Baseline|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
10935793|NCT00737204|BG001|Baseline|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
10935794|NCT00737204|BG002|Baseline|Total|Total of all reporting groups
10935795|NCT00737204|FG000|Participant Flow|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day.
10935796|NCT00737204|FG001|Participant Flow|Placebo|Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day.
10935797|NCT00737204|OG000|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
10935798|NCT00737204|OG001|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
11176412|NCT02036502|BG000|Baseline|Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg|Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
11176413|NCT02036502|BG001|Baseline|Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg|Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176414|NCT02036502|BG002|Baseline|Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
10935799|NCT00737204|EG000|Reported Event|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
10935800|NCT00737204|EG001|Reported Event|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
10935801|NCT00737243|BG000|Baseline|Patients With Tumor Assays Performed|Of 289 patients initially enrolled, 252 had successful assays performed. 37 patients had insufficient tissue for assay and came off study.
10935802|NCT00737243|FG000|Participant Flow|All Patients With a Successful Tumor Assays Performed|Subjects in this group had a successful molecular assay of biopsy tissue
10935803|NCT00737243|OG000|Outcome|More Treatment Responsive|Patients who received assay-directed therapy for tumor types with a predicted median survival ≥ 12 months.
10935804|NCT00737243|OG001|Outcome|Less Treatment Responsive|Patients who received assay-directed therapy for tumors with a predicted median survival ≤ 12 months
10935805|NCT00737243|OG000|Outcome|Patients With Successful Tumor Assays Performed|In 252 participants successful assays were performed. In 29 participants the amount of tumour and/or viable RNA present in the biopsy specimen was inadequate.
10935806|NCT00737243|EG000|Reported Event|All Treated Patients|
10935807|NCT00737360|BG000|Baseline|TAS-106|
10935808|NCT00737360|FG000|Participant Flow|TAS-106|
10935809|NCT00737360|OG000|Outcome|TAS-106|
10935810|NCT00737360|EG000|Reported Event|TAS-106|
10935811|NCT00737438|BG000|Baseline|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
10935812|NCT00737438|FG000|Participant Flow|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
10935813|NCT00737438|OG000|Outcome|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
10935814|NCT00737438|EG000|Reported Event|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
10935815|NCT00737464|BG000|Baseline|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
10935816|NCT00737464|FG000|Participant Flow|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
10935817|NCT00737464|OG000|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
10935818|NCT00737464|EG000|Reported Event|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
10935819|NCT00737477|BG000|Baseline|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
10935820|NCT00737477|FG000|Participant Flow|Mircera in Chronic Kidney Disease (CKD)-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the dose adaptation period (DAP) to maintain target hemoglobin (Hb) concentrations within 10 to 12 grams per deciliter (g/dL). Treatment continued during a designated efficacy evaluation period (EEP) from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
10935821|NCT00737477|OG000|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
10935822|NCT00737477|EG000|Reported Event|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
10935823|NCT00737529|BG000|Baseline|Lenalidomide|Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
10935824|NCT00737529|FG000|Participant Flow|Lenalidomide|Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
10935825|NCT00737529|OG000|Outcome|Lenalidomide|Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
10935826|NCT00737529|EG000|Reported Event|Lenalidomide|Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
10935827|NCT00737568|BG000|Baseline|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
10935828|NCT00737568|BG001|Baseline|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
10935829|NCT00737568|BG002|Baseline|Total|Total of all reporting groups
10935830|NCT00737568|FG000|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily
10935831|NCT00737568|FG001|Participant Flow|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
10935832|NCT00737568|OG000|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
10935833|NCT00737568|OG001|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
10935834|NCT00737568|EG000|Reported Event|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
11176415|NCT02036502|BG003|Baseline|Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
10935835|NCT00737568|EG001|Reported Event|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
10935836|NCT00737633|BG000|Baseline|16-week Population|subjects who were randomized to placebo in previous study
10935837|NCT00737633|BG001|Baseline|72-week Population|subjects who were randomized to active during previous study
10935838|NCT00737633|BG002|Baseline|Total|Total of all reporting groups
10935839|NCT00737633|FG000|Participant Flow|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
10935840|NCT00737633|FG001|Participant Flow|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
10935841|NCT00737633|OG000|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
10935842|NCT00737633|OG001|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
10935843|NCT00737633|EG000|Reported Event|16-week Population|subjects who were randomized to placebo in previous study
10935844|NCT00737633|EG001|Reported Event|72-week Population|subjects who were randomized to active during previous study
11192125|NCT02137369|EG000|Reported Event|SSRI|Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily, for 12 weeks
10935845|NCT00737672|BG000|Baseline|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm.~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis."
10935846|NCT00737672|BG001|Baseline|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm.~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis."
10935847|NCT00737672|BG002|Baseline|Total|Total of all reporting groups
10935848|NCT00737672|FG000|Participant Flow|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
10935849|NCT00737672|FG001|Participant Flow|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
10935850|NCT00737672|OG000|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
10935851|NCT00737672|OG001|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
10935852|NCT00737672|EG000|Reported Event|VIABAHN Treatment Group|Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
10935853|NCT00737672|EG001|Reported Event|PTA Treatment Group|Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
10935854|NCT00737698|BG000|Baseline|Exercise|"Exercise~Exercise: Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks"
10935855|NCT00737698|BG001|Baseline|Repetitive Magnetic Stimulation|"Repetitive magnetic stimulation~Repetitive magnetic stimulation: Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks"
10935856|NCT00737698|BG002|Baseline|Control|No active treatment
10935857|NCT00737698|BG003|Baseline|Total|Total of all reporting groups
10935858|NCT00737698|FG000|Participant Flow|Exercise|"Exercise~Exercise: Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks"
10935859|NCT00737698|FG001|Participant Flow|Repetitive Magnetic Stimulation|"Repetitive magnetic stimulation~Repetitive magnetic stimulation: Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks"
10935860|NCT00737698|FG002|Participant Flow|Control|No active treatment
10935861|NCT00737698|OG000|Outcome|Exercise|"Exercise~Exercise: Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks"
10935862|NCT00737698|OG001|Outcome|Repetitive Magnetic Stimulation|"Repetitive magnetic stimulation~Repetitive magnetic stimulation: Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks"
10935863|NCT00737698|OG002|Outcome|Control|No active treatment
10935864|NCT00737698|EG000|Reported Event|Exercise|"Exercise~Exercise: Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks"
10935865|NCT00737698|EG001|Reported Event|Repetitive Magnetic Stimulation|"Repetitive magnetic stimulation~Repetitive magnetic stimulation: Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks"
10935866|NCT00737698|EG002|Reported Event|Control|No active treatment
10935867|NCT00737711|BG000|Baseline|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
10935868|NCT00737711|FG000|Participant Flow|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
10935869|NCT00737711|OG000|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
10935870|NCT00737711|EG000|Reported Event|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
10935871|NCT00737737|BG000|Baseline|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
10935872|NCT00737737|BG001|Baseline|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
10935873|NCT00737737|BG002|Baseline|Total|Total of all reporting groups
10935874|NCT00737737|FG000|Participant Flow|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
10935875|NCT00737737|FG001|Participant Flow|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
10851566|NCT00306995|OG006|Outcome|SB218352_2AL Subset 1|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
10851567|NCT00306995|OG007|Outcome|SB218352_15 Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851568|NCT00306995|OG008|Outcome|SB218352_8 Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851569|NCT00306995|OG009|Outcome|SB218352_4 Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851570|NCT00306995|OG010|Outcome|SB218352_2 Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851571|NCT00306995|OG011|Outcome|SB218352_8AL Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851572|NCT00306995|OG012|Outcome|SB218352_4AL Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851573|NCT00306995|OG013|Outcome|SB218352_2AL Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851574|NCT00306995|OG002|Outcome|SB218352_4 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851575|NCT00306995|OG000|Outcome|SB218352_15 Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851576|NCT00306995|OG001|Outcome|SB218352_8 Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851577|NCT00306995|OG002|Outcome|SB218352_4 Group|Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851578|NCT00306995|OG003|Outcome|SB218352_2 Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851579|NCT00306995|OG004|Outcome|SB218352_8AL Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851580|NCT00306995|OG005|Outcome|SB218352_4AL Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851581|NCT00306995|OG006|Outcome|SB218352_2AL Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
10851582|NCT00306995|OG000|Outcome|SB218352_15 Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851583|NCT00306995|OG001|Outcome|SB218352_8 Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
11176416|NCT02036502|BG004|Baseline|Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176417|NCT02036502|BG005|Baseline|Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg|Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
10935876|NCT00737737|OG000|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
10935877|NCT00737737|OG001|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
10935878|NCT00737737|EG000|Reported Event|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
10935879|NCT00737737|EG001|Reported Event|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
10935880|NCT00737893|BG000|Baseline|Erythropoietin (EPO)|"20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.~Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery."
10935881|NCT00737893|BG001|Baseline|Placebo|"Placebo doses given the day before surgery, the day of surgery, and the day after surgery.~Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery."
10935882|NCT00737893|BG002|Baseline|Total|Total of all reporting groups
10935883|NCT00737893|FG000|Participant Flow|Erythropoietin (EPO)|"20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.~Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery."
10935884|NCT00737893|FG001|Participant Flow|Placebo|"Placebo doses given the day before surgery, the day of surgery, and the day after surgery.~Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery."
10935885|NCT00737893|OG000|Outcome|Erythropoietin (EPO)|"20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.~Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery."
10935886|NCT00737893|OG001|Outcome|Placebo|"Placebo doses given the day before surgery, the day of surgery, and the day after surgery.~Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery."
10935887|NCT00737893|EG000|Reported Event|Erythropoietin (EPO)|"20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.~Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery."
10935888|NCT00737893|EG001|Reported Event|Placebo|"Placebo doses given the day before surgery, the day of surgery, and the day after surgery.~Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery."
10935889|NCT00738023|BG000|Baseline|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
10935890|NCT00738023|BG001|Baseline|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
11176418|NCT02036502|BG006|Baseline|Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg|Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
11176419|NCT02036502|BG007|Baseline|Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg|Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
11176420|NCT02036502|BG008|Baseline|Total|Total of all reporting groups
11192126|NCT02137369|EG001|Reported Event|Cognitive Behavioral Therapy|"Cognitive Behavioral Therapy (CBT)~Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 1-hour sessions over 12 weeks."
10935891|NCT00738023|BG002|Baseline|Total|Total of all reporting groups
10935892|NCT00738023|FG000|Participant Flow|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
10935893|NCT00738023|FG001|Participant Flow|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
10935894|NCT00738023|OG000|Outcome|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
10935895|NCT00738023|OG001|Outcome|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
10935896|NCT00738023|OG000|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours~Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks~Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours~Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
10935897|NCT00738023|EG000|Reported Event|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
10935898|NCT00738023|EG001|Reported Event|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
10935899|NCT00738049|BG000|Baseline|Group 1|Group 1 received oral Darusentan 100mg during Phase 1 then placebo during Phase 2.
10935900|NCT00738049|BG001|Baseline|Group 2|Group 2 received placebo during Phase 1 then oral Darusentan 100 mg during Phase 2.
10935901|NCT00738049|BG002|Baseline|Total|Total of all reporting groups
10935902|NCT00738049|FG000|Participant Flow|Darusentan Then Placebo,|Patients were randomized to oral Darusentan 100mg for 14 days and then underwent cardiac PET imaging. They then received placebo for 14 days and underwent PET imaging, followed by a washout period of 14 days and completed the final cardiac PET scan. Patients and physicians were blinded to medication assignment.
10935903|NCT00738049|FG001|Participant Flow|Placebo, Then Darusentan 100mg|Patients were randomized to oral placebo for 14 days, then underwent PET imaging. Study patients then received Darusentan 100mg for 14 days. The patients underwent cardiac PET imaging followed by a 14 day washout period and final PET scan. Patients and physicians were blinded to medication assignment.
10935904|NCT00738049|OG000|Outcome|Baseline|All patients underwent a baseline assessment of Markovian homogeneity before receiving darusentan or placebo
10935905|NCT00738049|OG001|Outcome|Darusentan 100mg|All patients underwent a baseline assessment of Markovian homogeneity while taking darusentan
10935906|NCT00738049|OG000|Outcome|Darusentan 100mg at Rest|All patients underwent assessment of rest flow while receiving darusentan
10935907|NCT00738049|OG001|Outcome|Darusentan 100mg at Hyperemia|All patients underwent assessment of hyperemic flow while receiving darusentan
10935908|NCT00738049|OG002|Outcome|Baseline at Rest|All patients underwent a baseline assessment of resting flow before receiving darusentan or placebo
10935909|NCT00738049|OG003|Outcome|Baseline at Hyperemia|All patients underwent a baseline assessment of hyperemic flow before receiving darusentan or placebo
10935910|NCT00738049|OG000|Outcome|Baseline|All patients underwent a baseline assessment of CFR before receiving darusentan or placebo
11176421|NCT02036502|FG000|Participant Flow|Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg|Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
10935911|NCT00738049|OG001|Outcome|Darusentan 100mg|All patients underwent a assessment of CFR while receiving darusentan
10935912|NCT00738049|EG000|Reported Event|Group 1|Darusentan 100mg during Phase 1, Placebo during Phase 2
10935913|NCT00738049|EG001|Reported Event|Group 2|Received placebo during Phase 1, Darusentan 100mg during Phase 2
10935914|NCT00738062|BG000|Baseline|Open-Label Droxidopa|Only participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
10935915|NCT00738062|BG001|Baseline|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
11176422|NCT02036502|FG001|Participant Flow|Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg|Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
10935916|NCT00738062|BG002|Baseline|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10935917|NCT00738062|BG003|Baseline|Total|Total of all reporting groups
10935918|NCT00738062|FG000|Participant Flow|Open-Label Droxidopa|3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
10935919|NCT00738062|FG001|Participant Flow|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10935920|NCT00738062|FG002|Participant Flow|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
11176423|NCT02036502|FG002|Participant Flow|Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
10935921|NCT00738062|OG000|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10935922|NCT00738062|OG001|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10935923|NCT00738062|EG000|Reported Event|Three Month Open-Label Droxidopa|all patients who participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
10935924|NCT00738062|EG001|Reported Event|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10935925|NCT00738062|EG002|Reported Event|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10935926|NCT00738062|EG003|Reported Event|Long-Term Follow-up|Open-label treatment with droxidopa (t.i.d) following the double-blind randomization phase.
10935927|NCT00738062|EG004|Reported Event|Total Droxidopa|All Patients exposed to droxidopa
10935928|NCT00738101|BG000|Baseline|Fish Oil Emulsion Arm|"In infants who meet the eligibility criteria for Fish Oil Emulsion arm received Fish Oil Emulsion (Omegaven) after enrollment under the study.~Therapy with Fish Oil Emulsion (Omegaven) was provided at a dose of 1 gm/kg/day (by continuous infusion) and was infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If previously on Intralipid, it was stopped prior to initiation of Fish Oil Emulsion.Fish oil emulsion. Treatment was given for as long as the child needed any TPN. If the infant no longer required any TPN, then the Omegaven was stopped. Omegaven was continued even after resolution of cholestasis, as long as the need for parenteral nutrition persisted."
10935929|NCT00738101|FG000|Participant Flow|Fish Oil Emulsion Arm|"In infants who meet the eligibility criteria for Fish Oil Emulsion arm received Fish Oil Emulsion (Omegaven) after enrollment under the study.~Therapy with Fish Oil Emulsion (Omegaven) was provided at a dose of 1 gm/kg/day (by continuous infusion) and was infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If previously on Intralipid, it was stopped prior to initiation of Fish Oil Emulsion.Fish oil emulsion. Treatment was given for as long as the child needed any TPN. If the infant no longer required any TPN, then the Omegaven was stopped. Omegaven was continued even after resolution of cholestasis, as long as the need for parenteral nutrition persisted."
10935930|NCT00738101|OG000|Outcome|Fish Oil Emulsion Arm|Once eligible, Soybean Oil Emulsion was discontinued and Fish Oil Emulsion was commenced at 1 g/kg/d. Fish Oil Emulsion was provided as an infusion over 18-24 hours a day. Fish Oil Emulsion was provided in a dedicated peripheral or central venous access.
10935931|NCT00738101|EG000|Reported Event|Fish Oil Emulsion Arm|"Once eligible, Soybean Oil Emulsion was discontinued and Fish Oil Emulsion was commenced at 1 g/kg/d. Fish Oil Emulsion was provided as an infusion over 18-24 hours a day. Fish Oil Emulsion was provided in a dedicated peripheral or central venous access.~Any cause mortality prior to the End of Study"
10935932|NCT00738283|BG000|Baseline|Observational Group|Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
10935933|NCT00738283|FG000|Participant Flow|Observational Group|Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
10935934|NCT00738283|OG000|Outcome|Observational Group|Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
10935935|NCT00738283|EG000|Reported Event|Observational Group|Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
10935936|NCT00738361|BG000|Baseline|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
10935937|NCT00738361|FG000|Participant Flow|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
10935938|NCT00738361|OG000|Outcome|Nab-paclitaxel|"Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.~nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days."
10935939|NCT00738361|OG000|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
10935940|NCT00738361|EG000|Reported Event|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
10935941|NCT00738374|BG000|Baseline|CLB + R: Not Randomized|Participants began a 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants who completed the induction treatment with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
10935942|NCT00738374|BG001|Baseline|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
10935943|NCT00738374|BG002|Baseline|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
10935944|NCT00738374|BG003|Baseline|Total|Total of all reporting groups
10935945|NCT00738374|FG000|Participant Flow|Chlorambucil (CLB) Plus (+) Rituximab (R): Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 milligrams per square meter (mg/m^2), orally (PO) as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, intravenously (IV), on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with complete response (CR), complete response with incomplete bone marrow recovery (CRi), or partial response (PR) were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
10935946|NCT00738374|FG001|Participant Flow|CLB + R: Completed Induction Treament But Not Randomized|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants were not randomized to receive further treatment or observation.
10935947|NCT00738374|FG002|Participant Flow|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
10935948|NCT00738374|FG003|Participant Flow|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
10935949|NCT00738374|OG000|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
10935950|NCT00738374|OG000|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
10935951|NCT00738374|OG001|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
10935952|NCT00738374|OG000|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
10935953|NCT00738374|EG000|Reported Event|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
10935954|NCT00738374|EG001|Reported Event|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
10935955|NCT00738374|EG002|Reported Event|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
10935956|NCT00738400|BG000|Baseline|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
10935957|NCT00738400|BG001|Baseline|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
10935958|NCT00738400|BG002|Baseline|Total|Total of all reporting groups
10935959|NCT00738400|FG000|Participant Flow|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
10935960|NCT00738400|FG001|Participant Flow|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
10935961|NCT00738400|OG000|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
10935962|NCT00738400|OG001|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
10935963|NCT00738400|EG000|Reported Event|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
10935964|NCT00738400|EG001|Reported Event|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
10935965|NCT00738426|BG000|Baseline|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
10935966|NCT00738426|BG001|Baseline|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
10935967|NCT00738426|BG002|Baseline|Total|Total of all reporting groups
10935968|NCT00738426|FG000|Participant Flow|Erchonia ML Scanner (MLS)|"red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
10935969|NCT00738426|FG001|Participant Flow|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
10935970|NCT00738426|OG000|Outcome|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
10935971|NCT00738426|OG001|Outcome|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
10935972|NCT00738426|EG000|Reported Event|Erchonia ML Scanner (MLS)|"red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
10935973|NCT00738426|EG001|Reported Event|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
10935974|NCT00738530|BG000|Baseline|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
11176424|NCT02036502|FG003|Participant Flow|Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
11192127|NCT02137382|BG000|Baseline|Sequence Creon N/Creon® or Creon®/Creon N|Participants who were randomized to receive either Creon N or Creon.
10935975|NCT00738530|BG001|Baseline|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
10935976|NCT00738530|BG002|Baseline|Total|Total of all reporting groups
10935977|NCT00738530|FG000|Participant Flow|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) was administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
10935978|NCT00738530|FG001|Participant Flow|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
10935979|NCT00738530|OG000|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
10935980|NCT00738530|OG001|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
10935981|NCT00738530|EG000|Reported Event|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
10935982|NCT00738530|EG001|Reported Event|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
10935983|NCT00738543|BG000|Baseline|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
10935984|NCT00738543|FG000|Participant Flow|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
10935985|NCT00738543|OG000|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
10935986|NCT00738543|EG000|Reported Event|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
10935987|NCT00738673|BG000|Baseline|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
10935988|NCT00738673|BG001|Baseline|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
10935989|NCT00738673|BG002|Baseline|Total|Total of all reporting groups
10935990|NCT00738673|FG000|Participant Flow|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
10935991|NCT00738673|FG001|Participant Flow|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
10935992|NCT00738673|OG000|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
10935993|NCT00738673|OG001|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
10935994|NCT00738673|EG000|Reported Event|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
10935995|NCT00738673|EG001|Reported Event|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
10935996|NCT00738699|BG000|Baseline|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
10935997|NCT00738699|BG001|Baseline|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
10935998|NCT00738699|BG002|Baseline|Total|Total of all reporting groups
10935999|NCT00738699|FG000|Participant Flow|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
10936000|NCT00738699|FG001|Participant Flow|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
10936001|NCT00738699|OG000|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
10936002|NCT00738699|OG001|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
10936003|NCT00738699|EG000|Reported Event|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
11234205|NCT02432703|BG000|Baseline|Placebo|Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.
11176425|NCT02036502|FG004|Participant Flow|Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176426|NCT02036502|FG005|Participant Flow|Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg|Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
11176427|NCT02036502|FG006|Participant Flow|Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg|Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
11176428|NCT02036502|FG007|Participant Flow|Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg|Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
11176429|NCT02036502|OG000|Outcome|Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg|Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
11176430|NCT02036502|OG001|Outcome|Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg|Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176431|NCT02036502|OG002|Outcome|Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176432|NCT02036502|OG003|Outcome|Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
11176433|NCT02036502|OG004|Outcome|Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176434|NCT02036502|OG005|Outcome|Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg|Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
11176435|NCT02036502|OG006|Outcome|Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg|Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
11176436|NCT02036502|OG007|Outcome|Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg|Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
11176437|NCT02036502|OG008|Outcome|Pooled rrMM Cohort|Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
11176438|NCT02036502|OG009|Outcome|Pooled rMM Cohort|Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
11176439|NCT02036502|EG000|Reported Event|Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg|Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
11176440|NCT02036502|EG001|Reported Event|Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg|Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176441|NCT02036502|EG002|Reported Event|Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176442|NCT02036502|EG003|Reported Event|Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
11176443|NCT02036502|EG004|Reported Event|Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg|Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
11176444|NCT02036502|EG005|Reported Event|Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg|Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
11176445|NCT02036502|EG006|Reported Event|Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg|Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
11176446|NCT02036502|EG007|Reported Event|Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg|Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
10936004|NCT00738699|EG001|Reported Event|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
10936005|NCT00738881|BG000|Baseline|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
10936006|NCT00738881|BG001|Baseline|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
10936007|NCT00738881|BG002|Baseline|Total|Total of all reporting groups
10936008|NCT00738881|FG000|Participant Flow|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
10936009|NCT00738881|FG001|Participant Flow|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
10936010|NCT00738881|OG000|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
10936011|NCT00738881|OG001|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
10936012|NCT00738881|EG000|Reported Event|Arm I|erlotinib hydrochloride: Given orally
10936013|NCT00738881|EG001|Reported Event|Arm II|pemetrexed disodium: Given IV
10936014|NCT00738894|BG000|Baseline|Device Closure|"PFO closure with study septal occluder device plus antiplatelet medical therapy~Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder~Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol"
10936015|NCT00738894|BG001|Baseline|Medical Management|"Antiplatelet medical therapy alone~Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol"
10936016|NCT00738894|BG002|Baseline|Total|Total of all reporting groups
10936017|NCT00738894|FG000|Participant Flow|Device Closure|"PFO closure with study septal occluder device plus antiplatelet medical therapy~Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder~Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol"
10936018|NCT00738894|FG001|Participant Flow|Medical Management|"Antiplatelet medical therapy alone~Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol"
10936019|NCT00738894|OG000|Outcome|Device Closure|"PFO closure with study septal occluder device plus antiplatelet medical therapy~Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder~Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol"
10936020|NCT00738894|OG001|Outcome|Medical Management|"Antiplatelet medical therapy alone~Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol"
10936021|NCT00738894|EG000|Reported Event|Device Closure|"PFO closure with study septal occluder device plus antiplatelet medical therapy~Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder~Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol"
10936022|NCT00738894|EG001|Reported Event|Medical Management|"Antiplatelet medical therapy alone~Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol"
10936023|NCT00739102|BG000|Baseline|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
10936024|NCT00739102|FG000|Participant Flow|S.M.A.R.T.® Nitinol Stent System|The Cordis S.M.A.R.T. ®Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
10936025|NCT00739102|OG000|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
10936026|NCT00739102|EG000|Reported Event|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
10936027|NCT00739297|BG000|Baseline|All Participants|Combined participants from all arms.
10936028|NCT00739297|FG000|Participant Flow|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
11176447|NCT02036515|BG000|Baseline|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
11176448|NCT02036515|BG001|Baseline|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
10936029|NCT00739297|FG001|Participant Flow|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936030|NCT00739297|FG002|Participant Flow|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936031|NCT00739297|FG003|Participant Flow|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936032|NCT00739297|FG004|Participant Flow|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936033|NCT00739297|FG005|Participant Flow|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936034|NCT00739297|FG006|Participant Flow|Total|"Consistent with the incomplete-block design of this study, 6 treatments (placebo and 5 active-dose levels) were administered during only 4 treatment periods. In other words, in this 4-period crossover design, no patient received all 6 treatments and thus some treatments were not~received by all of the patients. Therefore, the TOTAL number of participants across ALL the dose levels provides the best metric to follow the consistency of patient flow from one treatment period to the next treatment period."
10936035|NCT00739297|OG000|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936036|NCT00739297|OG001|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936037|NCT00739297|OG002|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936038|NCT00739297|OG003|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936039|NCT00739297|OG004|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936040|NCT00739297|OG005|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936041|NCT00739297|OG000|Outcome|Montelukast+Albuterol|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Albuterol (data for each patient are pooled across all 3 administrations of active albuterol, as added to active montelukast)
10936042|NCT00739297|OG001|Outcome|Montelukast+ Placebo|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Placebo for Albuterol (data for each patient are pooled across all 3 administrations of placebo for albuterol, as added to active montelukast)
10936043|NCT00739297|EG000|Reported Event|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
11176449|NCT02036515|BG002|Baseline|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
11176450|NCT02036515|BG003|Baseline|Total|Total of all reporting groups
10851584|NCT00306995|OG002|Outcome|SB218352_4 Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10936044|NCT00739297|EG001|Reported Event|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
11176451|NCT02036515|FG000|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
10851585|NCT00306995|OG003|Outcome|SB218352_2 Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851586|NCT00306995|OG004|Outcome|SB218352_8AL Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851587|NCT00306995|OG005|Outcome|SB218352_4AL Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851588|NCT00306995|OG006|Outcome|SB218352_2AL Subset 2|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
10851589|NCT00306995|EG000|Reported Event|SB218352_15 Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851590|NCT00306995|EG001|Reported Event|SB218352_8 Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851591|NCT00306995|EG002|Reported Event|SB218352_4 Group|Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851592|NCT00306995|EG003|Reported Event|SB218352_2 Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851593|NCT00306995|EG004|Reported Event|SB218352_8AL Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851594|NCT00306995|EG005|Reported Event|SB218352_4AL Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851595|NCT00306995|EG006|Reported Event|SB218352_2AL Group|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
10851596|NCT00307034|BG000|Baseline|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
10851597|NCT00307034|BG001|Baseline|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
10851598|NCT00307034|BG002|Baseline|Total|Total of all reporting groups
10851599|NCT00307034|FG000|Participant Flow|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
10851722|NCT00307736|BG000|Baseline|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib.
10851723|NCT00307736|FG000|Participant Flow|Phase 1 (Erlotinib 50mg)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
11176452|NCT02036515|FG001|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
11176453|NCT02036515|FG002|Participant Flow|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
11176454|NCT02036515|OG000|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
10851686|NCT00307437|OG000|Outcome|Group I: Placebo|Placebo partcipants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
10851687|NCT00307437|OG002|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
10851688|NCT00307437|OG001|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
10851689|NCT00307437|OG002|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
10851690|NCT00307437|OG000|Outcome|Group 1: Ustekinumab 45mg Every 8 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28, 36 and 44.
10851691|NCT00307437|OG001|Outcome|Group 2: Ustekinumab 45mg Every 12 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
10851692|NCT00307437|OG002|Outcome|Group 3: Ustekinumab 90 mg Every 8 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16., 28, 36 and 44.
10851693|NCT00307437|OG003|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
10851694|NCT00307437|OG004|Outcome|Group 5: Combined (8 Week Dosing)|Combined Groups 1 and 3 (dosing every 8 weeks)
10851695|NCT00307437|OG005|Outcome|Group 6: Combined (12 Week Dosing)|Combined Groups 2 and 4 (dosing every 12 weeks)
10851696|NCT00307437|EG000|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
10851697|NCT00307437|EG001|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
10851698|NCT00307437|EG002|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
10851699|NCT00307437|EG003|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
10851700|NCT00307437|EG004|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
10851701|NCT00307437|EG005|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) - patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
10851702|NCT00307437|EG006|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) - patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
10851703|NCT00307489|BG000|Baseline|Tenofovir DF|tenofovir DF 300 mg QD
10851704|NCT00307489|BG001|Baseline|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
10851705|NCT00307489|BG002|Baseline|Total|Total of all reporting groups
10851706|NCT00307489|FG000|Participant Flow|Tenofovir DF|tenofovir DF 300 mg QD
10851707|NCT00307489|FG001|Participant Flow|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
10851708|NCT00307489|OG000|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
10851709|NCT00307489|OG001|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
10851710|NCT00307489|EG000|Reported Event|Tenofovir DF|tenofovir DF 300 mg QD
10851711|NCT00307489|EG001|Reported Event|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
10851712|NCT00307684|BG000|Baseline|Overall Study Population|Prolonged release (PR) Osmotic Release Oral Systems (OROS) MPH 18 to 90 mg once daily during the OL phase. Subjects who had received at 52 weeks of uninterrupted treatment with PR OROS MPH and provided consent for the DB phase were randomly assigned to placebo or their previous dose of PR OROS MPH (18 to 90 mg once daily)
10851713|NCT00307684|FG000|Participant Flow|Active|PR OROS MPH 18 to 90 mg once daily
10851714|NCT00307684|FG001|Participant Flow|Placebo|matching placebo
10851715|NCT00307684|FG002|Participant Flow|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
10851716|NCT00307684|OG000|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
10851717|NCT00307684|OG001|Outcome|Placebo|matching placebo
10851718|NCT00307684|OG002|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
10851719|NCT00307684|EG000|Reported Event|Active|PR OROS MPH 18 to 90 mg once daily
10851720|NCT00307684|EG001|Reported Event|Placebo|matching placebo
10851721|NCT00307684|EG002|Reported Event|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
10851724|NCT00307736|FG001|Participant Flow|Phase 1 (100mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
10851725|NCT00307736|FG002|Participant Flow|Phase 1 (150mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
10851726|NCT00307736|FG003|Participant Flow|Phase II (100mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
10851727|NCT00307736|OG000|Outcome|5-FU, Bevacizumab, Erlotinib and Radiation|All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
10851728|NCT00307736|OG000|Outcome|Grade 3|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
10851729|NCT00307736|OG001|Outcome|Grade 4|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
10851730|NCT00307736|OG000|Outcome|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
10851731|NCT00307736|OG000|Outcome|Surgery, 5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Patients undergoing R0 resection following chemotherapy and radiation.~Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
10851732|NCT00307736|OG000|Outcome|Completed Study Therapy|"Patients who had pathologic complete response following completion of study therapy.~All patients receive chemo-radiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib."
10851733|NCT00307736|OG001|Outcome|Underwent Resection|"Patients who underwent R0 resection following study therapy~All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib."
10851734|NCT00307736|OG002|Outcome|Treated at MTD|"Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.~All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib."
10851735|NCT00307736|EG000|Reported Event|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
10851736|NCT00307801|BG000|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
10851737|NCT00307801|BG001|Baseline|Placebo|Matching placebo to be taken orally daily.
10851738|NCT00307801|BG002|Baseline|Total|Total of all reporting groups
10851739|NCT00307801|FG000|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
10851740|NCT00307801|FG001|Participant Flow|Placebo|Matching placebo to be taken orally daily
10851741|NCT00307801|OG000|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
10851742|NCT00307801|OG001|Outcome|Placebo|Matching placebo to be taken orally daily
10851743|NCT00307801|OG001|Outcome|Placebo|Matching placebo to be taken orally daily.
10851744|NCT00307801|EG000|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
10851745|NCT00307801|EG001|Reported Event|Placebo|Matching placebo to be taken orally daily
10936045|NCT00739297|EG002|Reported Event|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936046|NCT00739297|EG003|Reported Event|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936047|NCT00739297|EG004|Reported Event|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936048|NCT00739297|EG005|Reported Event|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
10936049|NCT00739310|BG000|Baseline|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
10936050|NCT00739310|FG000|Participant Flow|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
10936051|NCT00739310|OG000|Outcome|Pre-Treatment|Prior to Vest Treatment
10936052|NCT00739310|OG001|Outcome|Post Vest Treatment|12 months of intervention 2 x daily Vest Therapy
10936053|NCT00739310|EG000|Reported Event|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
10936054|NCT00739336|BG000|Baseline|Intervention|"A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.~Diabetes Prevention and Control: The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings."
10936055|NCT00739336|BG001|Baseline|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
10936056|NCT00739336|BG002|Baseline|Total|Total of all reporting groups
10936057|NCT00739336|FG000|Participant Flow|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
10936058|NCT00739336|FG001|Participant Flow|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
10936059|NCT00739336|OG000|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
10936060|NCT00739336|OG001|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
10936061|NCT00739336|EG000|Reported Event|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
10936062|NCT00739336|EG001|Reported Event|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
10936063|NCT00739583|BG000|Baseline|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
10936064|NCT00739583|BG001|Baseline|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
10936065|NCT00739583|BG002|Baseline|Total|Total of all reporting groups
10936066|NCT00739583|FG000|Participant Flow|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
10936067|NCT00739583|FG001|Participant Flow|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
10936068|NCT00739583|OG000|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
10936069|NCT00739583|OG001|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
10936070|NCT00739583|EG000|Reported Event|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
10936071|NCT00739583|EG001|Reported Event|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
10936072|NCT00739596|BG000|Baseline|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
10936073|NCT00739596|BG001|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
10936074|NCT00739596|BG002|Baseline|Total|Total of all reporting groups
10936075|NCT00739596|FG000|Participant Flow|Aliskiren Hydrochlorothiazide (HCTZ)|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
10936076|NCT00739596|FG001|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
10936077|NCT00739596|OG000|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
10936078|NCT00739596|OG001|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
10936079|NCT00739596|EG000|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks.
10936080|NCT00739596|EG001|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks.
10936081|NCT00739648|BG000|Baseline|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
10936082|NCT00739648|BG001|Baseline|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
10936083|NCT00739648|BG002|Baseline|Total|Total of all reporting groups
10936084|NCT00739648|FG000|Participant Flow|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
10936085|NCT00739648|FG001|Participant Flow|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
10936086|NCT00739648|OG000|Outcome|Placebo|Placebo inhaled twice daily (BID) via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
10936087|NCT00739648|OG001|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily (BID)via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
10936088|NCT00739648|OG000|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
10936089|NCT00739648|OG001|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
10936090|NCT00739648|OG000|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
10936091|NCT00739648|OG001|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
10936092|NCT00739648|EG000|Reported Event|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
10936093|NCT00739648|EG001|Reported Event|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
10936094|NCT00739661|BG000|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
10936095|NCT00739661|BG001|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
10936096|NCT00739661|BG002|Baseline|Total|Total of all reporting groups
10936097|NCT00739661|FG000|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
10936098|NCT00739661|FG001|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
10936099|NCT00739661|OG000|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
10936100|NCT00739661|OG001|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
10936101|NCT00739661|EG000|Reported Event|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
10936102|NCT00739661|EG001|Reported Event|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
10936103|NCT00739752|BG000|Baseline|Non-Framed-Offered|"Non-Framed, Information Only Condition. Vaccine Offered.~Non-Framed-Offered: Subjects received information only and are offered the vaccine."
10936104|NCT00739752|BG001|Baseline|Non-Framed-Recommended|"Non-Framed, Information Only Condition. Vaccine Recommended.~Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine."
10936105|NCT00739752|BG002|Baseline|Gain-Framed-Offered|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.~Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine."
10936106|NCT00739752|BG003|Baseline|Gain-Framed-Recommended|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.~Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine."
10936107|NCT00739752|BG004|Baseline|Loss-Framed-Offered|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.~Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine."
10936108|NCT00739752|BG005|Baseline|Loss-Framed-Recommended|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.~Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine."
10936109|NCT00739752|BG006|Baseline|Total|Total of all reporting groups
10936110|NCT00739752|FG000|Participant Flow|Non-Framed-Offered|"Non-Framed, Information Only Condition. Vaccine Offered.~Non-Framed-Offered: Subjects received information only and are offered the vaccine."
10936111|NCT00739752|FG001|Participant Flow|Non-Framed-Recommended|"Non-Framed, Information Only Condition. Vaccine Recommended.~Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine."
10936112|NCT00739752|FG002|Participant Flow|Gain-Framed-Offered|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.~Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine."
10936113|NCT00739752|FG003|Participant Flow|Gain-Framed-Recommended|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.~Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine."
10936114|NCT00739752|FG004|Participant Flow|Loss-Framed-Offered|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.~Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine."
10936115|NCT00739752|FG005|Participant Flow|Loss-Framed-Recommended|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.~Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine."
10936116|NCT00739752|OG000|Outcome|Non-Framed-Offered|"Non-Framed, Information Only Condition. Vaccine Offered.~Non-Framed-Offered: Subjects received information only and are offered the vaccine."
10936117|NCT00739752|OG001|Outcome|Non-Framed-Recommended|"Non-Framed, Information Only Condition. Vaccine Recommended.~Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine."
10936118|NCT00739752|OG002|Outcome|Gain-Framed-Offered|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.~Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine."
10936119|NCT00739752|OG003|Outcome|Gain-Framed-Recommended|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.~Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine."
10936120|NCT00739752|OG004|Outcome|Loss-Framed-Offered|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.~Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine."
10936121|NCT00739752|OG005|Outcome|Loss-Framed-Recommended|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.~Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine."
10936122|NCT00739752|EG000|Reported Event|Non-Framed-Offered|"Non-Framed, Information Only Condition. Vaccine Offered.~Non-Framed-Offered: Subjects received information only and are offered the vaccine."
10936123|NCT00739752|EG001|Reported Event|Non-Framed-Recommended|"Non-Framed, Information Only Condition. Vaccine Recommended.~Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine."
10936124|NCT00739752|EG002|Reported Event|Gain-Framed-Offered|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.~Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine."
10936125|NCT00739752|EG003|Reported Event|Gain-Framed-Recommended|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.~Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine."
10936126|NCT00739752|EG004|Reported Event|Loss-Framed-Offered|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.~Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine."
10936127|NCT00739752|EG005|Reported Event|Loss-Framed-Recommended|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.~Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine."
10936128|NCT00739765|BG000|Baseline|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
10936129|NCT00739765|BG001|Baseline|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
10936130|NCT00739765|BG002|Baseline|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
10936131|NCT00739765|BG003|Baseline|Total|Total of all reporting groups
10936132|NCT00739765|FG000|Participant Flow|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
10936133|NCT00739765|FG001|Participant Flow|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
10936134|NCT00739765|FG002|Participant Flow|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
10936135|NCT00739765|OG000|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
10936136|NCT00739765|OG001|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
10936137|NCT00739765|OG002|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
10936138|NCT00739765|EG000|Reported Event|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
10936139|NCT00739765|EG001|Reported Event|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
10936140|NCT00739765|EG002|Reported Event|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
10936141|NCT00739908|BG000|Baseline|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
10936142|NCT00739908|BG001|Baseline|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
10936143|NCT00739908|BG002|Baseline|Total|Total of all reporting groups
10936144|NCT00739908|FG000|Participant Flow|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
10936145|NCT00739908|FG001|Participant Flow|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
10936146|NCT00739908|OG000|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational Reversible Monoamine Oxidase Inhibitor (MAOI)
10936147|NCT00739908|OG001|Outcome|Oral Placebo TID|No active medication, the same as a Sugar Pill
10936148|NCT00739908|OG000|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
10936149|NCT00739908|OG001|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
10936150|NCT00739908|EG000|Reported Event|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
10936151|NCT00739908|EG001|Reported Event|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
10936152|NCT00739934|BG000|Baseline|All Participants|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
10936153|NCT00739934|FG000|Participant Flow|All Participants|Voriconazole intravenous (IV) multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
10936154|NCT00739934|OG000|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
10936155|NCT00739934|OG000|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
10936156|NCT00739934|OG000|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
10936157|NCT00739934|OG000|Outcome|All Treatments|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
10936158|NCT00739934|OG000|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
10936159|NCT00739934|EG000|Reported Event|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
10936160|NCT00739934|EG001|Reported Event|Voriconazole Oral|Voriconazole oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
10936161|NCT00739960|BG000|Baseline|Open Label|Open label for Abatacept
10936162|NCT00739960|FG000|Participant Flow|Abatacept|Abatacept: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
10936163|NCT00739960|OG000|Outcome|Abatacept|Abatacept: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
10936164|NCT00739960|EG000|Reported Event|Abatacept|Abatacept: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
10936165|NCT00739973|BG000|Baseline|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
10936166|NCT00739973|BG001|Baseline|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936167|NCT00739973|BG002|Baseline|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936168|NCT00739973|BG003|Baseline|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936169|NCT00739973|BG004|Baseline|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
10936170|NCT00739973|BG005|Baseline|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936171|NCT00739973|BG006|Baseline|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936172|NCT00739973|BG007|Baseline|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936173|NCT00739973|BG008|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936174|NCT00739973|BG009|Baseline|Total|Total of all reporting groups
10936175|NCT00739973|FG000|Participant Flow|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
10936176|NCT00739973|FG001|Participant Flow|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936177|NCT00739973|FG002|Participant Flow|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936178|NCT00739973|FG003|Participant Flow|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936179|NCT00739973|FG004|Participant Flow|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
10936180|NCT00739973|FG005|Participant Flow|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936181|NCT00739973|FG006|Participant Flow|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936182|NCT00739973|FG007|Participant Flow|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
11176455|NCT02036515|OG001|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
11176456|NCT02036515|OG002|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
11176457|NCT02036515|EG000|Reported Event|Ertugliflozin 5 mg (Phase A+B)|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
10936183|NCT00739973|FG008|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936184|NCT00739973|OG000|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936185|NCT00739973|OG001|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936186|NCT00739973|OG000|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936187|NCT00739973|OG000|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
10936188|NCT00739973|OG001|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936189|NCT00739973|OG000|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
10936190|NCT00739973|OG000|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936191|NCT00739973|OG001|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936192|NCT00739973|OG001|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936193|NCT00739973|OG001|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936194|NCT00739973|OG002|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936195|NCT00739973|OG003|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936196|NCT00739973|OG004|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
10936197|NCT00739973|OG005|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
11176458|NCT02036515|EG001|Reported Event|Ertugliflozin 15 mg (Phase A+B)|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
11176459|NCT02036515|EG002|Reported Event|Placebo (Phase A+B)|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
11176460|NCT02036541|BG000|Baseline|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
11176461|NCT02036541|FG000|Participant Flow|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
11176462|NCT02036541|OG000|Outcome|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
11176463|NCT02036541|EG000|Reported Event|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
11176464|NCT02036580|BG000|Baseline|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
11176465|NCT02036580|BG001|Baseline|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
11176466|NCT02036580|BG002|Baseline|Placebo|Placebo Q4W intravenously dosed for 24 weeks
11176467|NCT02036580|BG003|Baseline|Total|Total of all reporting groups
11176468|NCT02036580|FG000|Participant Flow|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
11176469|NCT02036580|FG001|Participant Flow|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
11176470|NCT02036580|FG002|Participant Flow|Placebo|Placebo Q4W intravenously dosed for 24 weeks
11176471|NCT02036580|OG000|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
11176472|NCT02036580|OG001|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
11176473|NCT02036580|OG002|Outcome|Placebo|Placebo Q4W intravenously dosed for 24 weeks
11176474|NCT02036580|EG000|Reported Event|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
11176475|NCT02036580|EG001|Reported Event|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
11176476|NCT02036580|EG002|Reported Event|Placebo|Placebo Q4W intravenously dosed for 24 weeks
11176477|NCT02036645|BG000|Baseline|Placebo: SAD|Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
11176478|NCT02036645|BG001|Baseline|Medi1814 25 mg IV: SAD|Medi1814 25 mg IV: SAD cohort 1
11176479|NCT02036645|BG002|Baseline|Medi1814 100 mg IV: SAD|Medi1814 100 mg IV: SAD cohort 2
11176480|NCT02036645|BG003|Baseline|Medi1814 300 mg IV: SAD|Medi1814 300 mg IV: SAD cohort 3
11176481|NCT02036645|BG004|Baseline|Medi1814 900 mg IV: SAD|Medi1814 900 mg IV: SAD cohort 4
11176482|NCT02036645|BG005|Baseline|Medi1814 1800 mg IV: SAD|Medi1814 1800 mg IV: SAD cohort 5
11176483|NCT02036645|BG006|Baseline|Medi1814 100 mg SC: SAD|Medi1814 100 mg SC: CAD cohort 6
11176484|NCT02036645|BG007|Baseline|Placebo: MAD|Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
11176485|NCT02036645|BG008|Baseline|Medi1814 300 mg IV: MAD|Medi1814 300 mg IV: MAD cohort 7
11176486|NCT02036645|BG009|Baseline|Medi 1814 900 mg IV: MAD|Medi1814 900 mg IV: MAD cohort 8
11176487|NCT02036645|BG010|Baseline|Medi1814 1800 mg IV: MAD|Medi1814 1800 mg IV: MAD cohort 9
11176488|NCT02036645|BG011|Baseline|Medi1814 200 mg SC: MAD|Medi1814 200 mg SC: MAD cohort 10
11176489|NCT02036645|BG012|Baseline|Total|Total of all reporting groups
11176490|NCT02036645|FG000|Participant Flow|Placebo: SAD|Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
11176491|NCT02036645|FG001|Participant Flow|Medi1814 25 mg IV: SAD|Medi1814 25 mg IV: SAD cohort 1
11176492|NCT02036645|FG002|Participant Flow|Medi1814 100 mg IV: SAD|Medi1814 100 mg IV: SAD cohort 2
11176493|NCT02036645|FG003|Participant Flow|Medi1814 300 mg IV: SAD|Medi1814 300 mg IV: SAD cohort 3
11176494|NCT02036645|FG004|Participant Flow|Medi1814 900 mg IV: SAD|Medi1814 900 mg IV: SAD cohort 4
11176495|NCT02036645|FG005|Participant Flow|Medi1814 1800 mg IV: SAD|Medi1814 1800 mg IV: SAD cohort 5
11176496|NCT02036645|FG006|Participant Flow|Medi1814 100 mg SC: SAD|Medi1814 100 mg SC: CAD cohort 6
11176497|NCT02036645|FG007|Participant Flow|Placebo: MAD|Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
11176498|NCT02036645|FG008|Participant Flow|Medi1814 300 mg IV: MAD|Medi1814 300 mg IV: MAD cohort 7
11176499|NCT02036645|FG009|Participant Flow|Medi1814 900 mg IV: MAD|Medi1814 900 mg IV: MAD cohort 8
11176500|NCT02036645|FG010|Participant Flow|Medi1814 1800 mg IV: MAD|Medi1814 1800 mg IV: MAD cohort 9
11176501|NCT02036645|FG011|Participant Flow|Medi1814 200 mg SC: MAD|Medi1814 200 mg SC: MAD cohort 10
11176502|NCT02036645|OG000|Outcome|Placebo: SAD|Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
11176503|NCT02036645|OG001|Outcome|Medi1814 25 mg IV: SAD|Medi1814 25 mg IV: SAD cohort 1
11176504|NCT02036645|OG002|Outcome|Medi1814 100 mg IV: SAD|Medi1814 100 mg IV: SAD cohort 2
11176505|NCT02036645|OG003|Outcome|Medi1814 300 mg IV: SAD|Medi1814 300 mg IV: SAD cohort 3
11176506|NCT02036645|OG004|Outcome|Medi1814 900 mg IV: SAD|Medi1814 900 mg IV: SAD cohort 4
11176507|NCT02036645|OG005|Outcome|Medi1814 1800 mg IV: SAD|Medi1814 1800 mg IV: SAD cohort 5
11176508|NCT02036645|OG006|Outcome|Medi1814 100 mg SC : SAD|Medi1814 100 mg SC: SAD cohort 6
11176509|NCT02036645|OG007|Outcome|Placebo: MAD|Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
11176510|NCT02036645|OG008|Outcome|Medi1814 300 mg IV: MAD|Medi1814 300 mg IV: MAD cohort 7
11176511|NCT02036645|OG009|Outcome|Medi1814 900 mg IV: MAD|Medi1814 900 mg IV: MAD cohort 8
11176512|NCT02036645|OG010|Outcome|Medi1814 1800 mg IV: MAD|Medi1814 1800 mg IV: MAD cohort 9
11176513|NCT02036645|OG011|Outcome|Medi1814 200 mg SC: MAD|Medi1814 200 mg SC: MAD cohort 10
11176514|NCT02036645|OG000|Outcome|Medi1814 25 mg IV: SAD|Medi1814 25 mg IV: SAD cohort 1
11176515|NCT02036645|OG001|Outcome|Medi1814 100 mg IV: SAD|Medi1814 100 mg IV: SAD cohort 2
11176516|NCT02036645|OG002|Outcome|Medi1814 300 mg IV: SAD|Medi1814 300 mg IV: SAD cohort 3
11176517|NCT02036645|OG003|Outcome|Medi1814 900 mg IV: SAD|Medi1814 900 mg IV: SAD cohort 4
11176518|NCT02036645|OG004|Outcome|Medi1814 1800 mg IV: SAD|Medi1814 1800 mg IV: SAD cohort 5
11176519|NCT02036645|OG005|Outcome|Medi1814 100 mg SC: SAD|Medi1814 100 mg SC: CAD cohort 6
11176520|NCT02036645|OG006|Outcome|Medi1814 300 mg IV: MAD|Medi1814 300 mg IV: MAD cohort 7
11176521|NCT02036645|OG007|Outcome|Medi1814 900 mg IV: MAD|Medi1814 900 mg IV: MAD cohort 8
11176522|NCT02036645|OG008|Outcome|Medi1814 1800 mg IV: MAD|Medi1814 1800 mg IV: MAD cohort 9
11176523|NCT02036645|OG009|Outcome|Medi1814 200 mg SC: MAD|Medi1814 200 mg SC: MAD cohort 10
10936198|NCT00739973|OG006|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936199|NCT00739973|OG007|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936200|NCT00739973|OG008|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936201|NCT00739973|EG000|Reported Event|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
10936202|NCT00739973|EG001|Reported Event|Aliskiren 150 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936203|NCT00739973|EG002|Reported Event|Aliskiren 300 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936204|NCT00739973|EG003|Reported Event|Amlodipine 5 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936205|NCT00739973|EG004|Reported Event|Amlodipine 10 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
10936206|NCT00739973|EG005|Reported Event|Aliskiren/Amlodipine 150/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936207|NCT00739973|EG006|Reported Event|Aliskiren/Amlodipine 150/10 mg Tablet|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936208|NCT00739973|EG007|Reported Event|Aliskiren/Amlodipine 300/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936209|NCT00739973|EG008|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
10936210|NCT00739999|BG000|Baseline|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
10936211|NCT00739999|BG001|Baseline|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
10936212|NCT00739999|BG002|Baseline|Total|Total of all reporting groups
10936213|NCT00739999|FG000|Participant Flow|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Age 6 - 10 years, at Tanner Stage 1. Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target low-density lipoprotein cholesterol (LDL-C) was not attained.
10936214|NCT00739999|FG001|Participant Flow|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Age 10 - 17 years, at Tanner Stage 2+. Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained.
10936215|NCT00739999|OG000|Outcome|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
10936216|NCT00739999|OG001|Outcome|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
10936217|NCT00739999|OG000|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
10936218|NCT00739999|OG001|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
10936219|NCT00739999|OG002|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
10936220|NCT00739999|OG003|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
10936221|NCT00739999|OG000|Outcome|Atorvastatin (5 mg, 10 mg, 20 mg): Tanner Stages 1 and 2+|Tanner Stage 1: Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated; Tanner Stage 2+: Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
10936222|NCT00739999|EG000|Reported Event|All Subjects (5 mg, 10 mg): Tanner Stage 1|Atorvastatin: subjects who stayed at initial dose of 5 mg/day for duration of study and subjects who titrated after Week 4 to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
10936223|NCT00739999|EG001|Reported Event|All Subjects (10 mg, 20 mg): Tanner Stage 2+|Atorvastatin: subjects who stayed at initial dose of 10 mg/day for duration of study and subjects who titrated to 20 mg/day after Week 4 if target LDL-C was not attained and study drug was well tolerated.
10936224|NCT00740051|BG000|Baseline|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
10936225|NCT00740051|BG001|Baseline|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
10936226|NCT00740051|BG002|Baseline|Total|Total of all reporting groups
10936227|NCT00740051|FG000|Participant Flow|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
10936228|NCT00740051|FG001|Participant Flow|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
10936229|NCT00740051|OG000|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
10936230|NCT00740051|OG001|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
10936231|NCT00740051|OG000|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
10936232|NCT00740051|EG000|Reported Event|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
10936233|NCT00740051|EG001|Reported Event|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
11176524|NCT02036645|OG006|Outcome|Medi1814 100 mg SC: SAD|Medi1814 100 mg SC: CAD cohort 6
10936234|NCT00740129|BG000|Baseline|Zoledronic Acid 5 mg|Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion.
10936235|NCT00740129|FG000|Participant Flow|Zoledronic Acid 5 mg|Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion.
10936236|NCT00740129|OG000|Outcome|Zoledronic Acid 5 mg|Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion.
10936237|NCT00740129|OG000|Outcome|Zoledronic Acid 5 mg|Participants received single re-treatment dose of zoledronic acid 5 mg by IV infusion.
10936238|NCT00740129|EG000|Reported Event|Zoledronic Acid 5 mg|Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion.
10936239|NCT00740207|BG000|Baseline|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936240|NCT00740207|BG001|Baseline|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936241|NCT00740207|BG002|Baseline|Total|Total of all reporting groups
10936242|NCT00740207|FG000|Participant Flow|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936243|NCT00740207|FG001|Participant Flow|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936244|NCT00740207|OG000|Outcome|VAS Score Prior to Injection of ISOVUE 250|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
10936245|NCT00740207|OG001|Outcome|VAS Score After Injection of ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936246|NCT00740207|OG002|Outcome|VAS Score Prior to Injection of VISIPAQUE 270|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
11176525|NCT02036645|OG009|Outcome|Medi1814 900 mg: MAD|Medi1814 900 mg IV: MAD cohort
10936247|NCT00740207|OG003|Outcome|VAS Score After Injection of VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936248|NCT00740207|OG000|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936249|NCT00740207|OG001|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936250|NCT00740207|EG000|Reported Event|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936251|NCT00740207|EG001|Reported Event|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
10936252|NCT00740220|BG000|Baseline|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
10936253|NCT00740220|FG000|Participant Flow|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
10936254|NCT00740220|OG000|Outcome|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
10936255|NCT00740220|EG000|Reported Event|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
10936256|NCT00740376|BG000|Baseline|Uniglide Mobile Bearing Unicondylar Knee System (MBK)|"Uniglide Mobile Bearing Unicondylar Knee System (MBK)~Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert)."
10936257|NCT00740376|BG001|Baseline|Uniglide Fixed Bearing Unicondylar Knee System (FBK)|"Uniglide Fixed Bearing Unicondylar Knee System (FBK)~Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764)."
10936258|NCT00740376|BG002|Baseline|Total|Total of all reporting groups
10936259|NCT00740376|FG000|Participant Flow|Uniglide Mobile Bearing Unicondylar Knee System (MBK)|"Uniglide Mobile Bearing Unicondylar Knee System (MBK)~Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert)."
10936260|NCT00740376|FG001|Participant Flow|Uniglide Fixed Bearing Unicondylar Knee System (FBK)|"Uniglide Fixed Bearing Unicondylar Knee System (FBK)~Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764)."
10936261|NCT00740376|OG000|Outcome|Uniglide Mobile Bearing Unicondylar Knee System (MBK)|"Uniglide Mobile Bearing Unicondylar Knee System (MBK)~Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert)."
10936262|NCT00740376|OG001|Outcome|Uniglide Fixed Bearing Unicondylar Knee System (FBK)|"Uniglide Fixed Bearing Unicondylar Knee System (FBK)~Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764)."
10936263|NCT00740376|EG000|Reported Event|Uniglide Mobile Bearing Unicondylar Knee System (MBK)|"Uniglide Mobile Bearing Unicondylar Knee System (MBK)~Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert)."
10936264|NCT00740376|EG001|Reported Event|Uniglide Fixed Bearing Unicondylar Knee System (FBK)|"Uniglide Fixed Bearing Unicondylar Knee System (FBK)~Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764)."
10936265|NCT00740584|BG000|Baseline|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
10936266|NCT00740584|FG000|Participant Flow|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
10936267|NCT00740584|OG000|Outcome|Open Label Active|
10936268|NCT00740584|OG000|Outcome|Open Label, Only Arm|"3%w/w SPL7013 vaginal gel (VivaGel)~3% SPL7013 Gel (VivaGel): A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days."
10936269|NCT00740584|EG000|Reported Event|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
10936270|NCT00740636|BG000|Baseline|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
10936271|NCT00740636|BG001|Baseline|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
10936272|NCT00740636|BG002|Baseline|Total|Total of all reporting groups
10936273|NCT00740636|FG000|Participant Flow|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
10936274|NCT00740636|FG001|Participant Flow|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
10936275|NCT00740636|OG000|Outcome|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
10936276|NCT00740636|OG001|Outcome|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
10936277|NCT00740636|EG000|Reported Event|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
10936278|NCT00740636|EG001|Reported Event|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
10936279|NCT00740714|BG000|Baseline|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
10936280|NCT00740714|BG001|Baseline|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
10936281|NCT00740714|BG002|Baseline|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
10936282|NCT00740714|BG003|Baseline|Total|Total of all reporting groups
10936283|NCT00740714|FG000|Participant Flow|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
10936284|NCT00740714|FG001|Participant Flow|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
10936285|NCT00740714|FG002|Participant Flow|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
10936286|NCT00740714|OG000|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
10936287|NCT00740714|OG001|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
10936288|NCT00740714|OG002|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
10936289|NCT00740714|EG000|Reported Event|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
10936290|NCT00740714|EG001|Reported Event|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
10936291|NCT00740714|EG002|Reported Event|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
10936292|NCT00740779|BG000|Baseline|Silodosin 4 mg|Silodosin 4 mg daily
10936293|NCT00740779|BG001|Baseline|Silodosin 8 mg|Silodosin 8 mg daily
10936294|NCT00740779|BG002|Baseline|Placebo|1 placebo capsule daily
10936295|NCT00740779|BG003|Baseline|Total|Total of all reporting groups
10936296|NCT00740779|FG000|Participant Flow|Silodosin 4 mg|Silodosin 4 mg daily
10936297|NCT00740779|FG001|Participant Flow|Silodosin 8 mg|Silodosin 8 mg daily
10936298|NCT00740779|FG002|Participant Flow|Placebo|1 placebo capsule daily
10936299|NCT00740779|OG000|Outcome|Silodosin 4 mg|Silodosin 4 mg daily
10936300|NCT00740779|OG001|Outcome|Silodosin 8 mg|Silodosin 8 mg daily
10936301|NCT00740779|OG002|Outcome|Placebo|1 placebo capsule daily
10936302|NCT00740779|EG000|Reported Event|Silodosin 4 mg|Silodosin 4 mg daily
10936303|NCT00740779|EG001|Reported Event|Silodosin 8 mg|Silodosin 8 mg daily
10936304|NCT00740779|EG002|Reported Event|Placebo|1 placebo capsule daily
10936305|NCT00740792|BG000|Baseline|MP29-02|azelastine HCl/fluticasone propionate
10936306|NCT00740792|BG001|Baseline|Azelastine HCL|active comparator of azelastine HCl
10936307|NCT00740792|BG002|Baseline|Fluticasone Propionate|active comparator of fluticasone propionate
10936308|NCT00740792|BG003|Baseline|Placebo|placebo control
10936309|NCT00740792|BG004|Baseline|Total|Total of all reporting groups
10936310|NCT00740792|FG000|Participant Flow|MP29-02|azelastine HCl/fluticasone propionate
10936311|NCT00740792|FG001|Participant Flow|Azelastine HCL|active comparator of azelastine HCl
10936312|NCT00740792|FG002|Participant Flow|Fluticasone Propionate|active comparator of fluticasone propionate
10936313|NCT00740792|FG003|Participant Flow|Placebo|placebo control
10936314|NCT00740792|OG000|Outcome|MP29-02|azelastine HCl/fluticasone propionate
10936315|NCT00740792|OG001|Outcome|Azelastine HCL|active comparator of azelastine HCl
10936316|NCT00740792|OG002|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
10936317|NCT00740792|OG003|Outcome|Placebo|placebo control
10936318|NCT00740792|EG000|Reported Event|MP29-02|azelastine HCl/fluticasone propionate
10936319|NCT00740792|EG001|Reported Event|Azelastine HCL|active comparator of azelastine HCl
10936320|NCT00740792|EG002|Reported Event|Fluticasone Propionate|active comparator of fluticasone propionate
10936321|NCT00740792|EG003|Reported Event|Placebo|placebo control
10936322|NCT00740831|BG000|Baseline|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
10936323|NCT00740831|BG001|Baseline|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
10936324|NCT00740831|BG002|Baseline|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
10936325|NCT00740831|BG003|Baseline|Total|Total of all reporting groups
11176526|NCT02036645|EG000|Reported Event|Placebo: SAD|Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
10936326|NCT00740831|FG000|Participant Flow|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
10936327|NCT00740831|FG001|Participant Flow|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
10936328|NCT00740831|FG002|Participant Flow|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
10936329|NCT00740831|OG000|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
10936330|NCT00740831|OG001|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
10936331|NCT00740831|OG002|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
10936332|NCT00740831|EG000|Reported Event|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
10936333|NCT00740831|EG001|Reported Event|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
11176527|NCT02036645|EG001|Reported Event|Medi1814 25 mg IV: SAD|Medi1814 25 mg IV: SAD cohort 1
11176528|NCT02036645|EG002|Reported Event|Medi1814 100 mg IV: SAD|Medi1814 100 mg IV: SAD cohort 2
11176529|NCT02036645|EG003|Reported Event|Medi1814 300 mg IV: SAD|Medi1814 300 mg IV: SAD cohort 3
11176530|NCT02036645|EG004|Reported Event|Medi1814 900 mg IV: SAD|Medi1814 900 mg IV: SAD cohort 4
10936334|NCT00740831|EG002|Reported Event|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
10936335|NCT00740857|BG000|Baseline|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
10936336|NCT00740857|BG001|Baseline|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
10936337|NCT00740857|BG002|Baseline|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
10936338|NCT00740857|BG003|Baseline|Total|Total of all reporting groups
10936339|NCT00740857|FG000|Participant Flow|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
10936340|NCT00740857|FG001|Participant Flow|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
10936341|NCT00740857|FG002|Participant Flow|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
10936342|NCT00740857|OG000|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
10936343|NCT00740857|OG001|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
10936344|NCT00740857|OG002|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
10936345|NCT00740857|EG000|Reported Event|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
10936346|NCT00740857|EG001|Reported Event|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
10936347|NCT00740857|EG002|Reported Event|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
10936348|NCT00740870|BG000|Baseline|Enrolled Cohort|All subjects enrolled
10936349|NCT00740870|FG000|Participant Flow|Enrolled|All subjects enrolled (n=171)
10936350|NCT00740870|OG000|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
10936351|NCT00740870|OG000|Outcome|Attempted Implant Cohort|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
10936352|NCT00740870|OG000|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
10936353|NCT00740870|OG000|Outcome|Implanted Cohort|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
10936354|NCT00740870|EG000|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
10936355|NCT00741013|BG000|Baseline|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
10936356|NCT00741013|BG001|Baseline|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
10936357|NCT00741013|BG002|Baseline|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
10936358|NCT00741013|BG003|Baseline|Total|Total of all reporting groups
10936359|NCT00741013|FG000|Participant Flow|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
10936360|NCT00741013|FG001|Participant Flow|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
10936361|NCT00741013|FG002|Participant Flow|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
10936362|NCT00741013|OG000|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
10936363|NCT00741013|OG001|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
10936364|NCT00741013|OG002|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
10936365|NCT00741013|EG000|Reported Event|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
10936366|NCT00741013|EG001|Reported Event|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
10936367|NCT00741013|EG002|Reported Event|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
10936368|NCT00741026|BG000|Baseline|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.~OR~Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days."
10936369|NCT00741026|FG000|Participant Flow|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.~OR~Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days.~Randomization information not available."
10936370|NCT00741026|OG000|Outcome|Placebo|
10936371|NCT00741026|OG001|Outcome|Olanzapine|
10936372|NCT00741026|EG000|Reported Event|Placebo|Placebo : (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
10936373|NCT00741026|EG001|Reported Event|Olanzapine|
10936374|NCT00741039|BG000|Baseline|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
10936375|NCT00741039|BG001|Baseline|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
10936376|NCT00741039|BG002|Baseline|Total|Total of all reporting groups
10936377|NCT00741039|FG000|Participant Flow|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
10936378|NCT00741039|FG001|Participant Flow|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
10936379|NCT00741039|OG000|Outcome|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
10936380|NCT00741039|OG001|Outcome|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
10936381|NCT00741039|EG000|Reported Event|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
10936382|NCT00741039|EG001|Reported Event|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
10936383|NCT00741091|BG000|Baseline|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
10936384|NCT00741091|FG000|Participant Flow|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
10936385|NCT00741091|OG000|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
10936386|NCT00741091|EG000|Reported Event|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
10936387|NCT00741104|BG000|Baseline|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
10936388|NCT00741104|FG000|Participant Flow|RA Patients|Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for >= the past 12 months.
10936389|NCT00741104|OG000|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
10936390|NCT00741104|EG000|Reported Event|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
10936391|NCT00741156|BG000|Baseline|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
10936392|NCT00741156|FG000|Participant Flow|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
10936393|NCT00741156|OG000|Outcome|Systemic Blood Flow Baseline|Systemic blood flow in baseline condition
10936394|NCT00741156|OG001|Outcome|Systemic Blood Flow After Enalaprilat|Systemic blood flow 20 minutes after enalaprilat
10936395|NCT00741156|OG002|Outcome|Pulmonary Blood Flow Baseline|Pulmonary blood flow baseline condition
10936396|NCT00741156|OG003|Outcome|Pulmonary Blood Flow After Enaliprilat|Pulmonary blood flow 20 minutes after enalaprilat
10936397|NCT00741156|OG004|Outcome|Cerebral Blood Flow Baseline|Cerebral blood flow at baseline
10936398|NCT00741156|OG005|Outcome|Cerebral Blood Flow After Enalaprilat|Cerebral blood flow 20 minutes after enalaprilat
10936399|NCT00741156|OG000|Outcome|Systemic Resistance at Baseline|systemic resistance in baseline condition
10936400|NCT00741156|OG001|Outcome|Systemic Resistance After Enalaprilat|systemic resistance is measured after enalaprilat
10936401|NCT00741156|OG002|Outcome|Pulmonary Resistance at Baseline|pulmonary resistance at baseline is measured
10936402|NCT00741156|OG003|Outcome|Pulmonary Resistance After Enalaprilat|pulmonary resistance is measured after enalaprilat
10936403|NCT00741156|OG004|Outcome|Cerebral Resistance at Baseline|cerebral resistance is measured in baseline condition
10936404|NCT00741156|OG005|Outcome|Cerebral Resistance After Enalaprilat|cerebral resistance is measured after enalaprilat
10936405|NCT00741156|EG000|Reported Event|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
10936406|NCT00741260|BG000|Baseline|N160 + C1500|Neratinib 160 mg + Capecitabine 1500 mg/sq m
10936407|NCT00741260|BG001|Baseline|N240 + C1500|Neratinib 240 mg + Capecitabine 1500 mg/sq m
11176531|NCT02036645|EG005|Reported Event|Medi1814 1800 mg IV: SAD|Medi1814 1800 mg IV: SAD cohort 5
10936408|NCT00741260|BG002|Baseline|N240 + C2000|Neratinib 240 mg + Capecitabine 2000 mg/sq m
11176532|NCT02036645|EG006|Reported Event|Medi1814 100 mg SC: SAD|Medi1814 100 mg SC: CAD cohort 6
11176533|NCT02036645|EG007|Reported Event|Placebo: MAD|Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
11176534|NCT02036645|EG008|Reported Event|Medi1814 300 mg IV: MAD|Medi1814 300 mg IV: MAD cohort 7
11176535|NCT02036645|EG009|Reported Event|Medi1814 900 mg IV: MAD|Medi1814 900 mg IV: MAD cohort 8
11176536|NCT02036645|EG010|Reported Event|Medi1814 1800 mg IV: MAD|Medi1814 1800 mg IV: MAD cohort 9
11176537|NCT02036645|EG011|Reported Event|Medi1814 200 mg SC: MAD|Medi1814 200 mg SC: MAD cohort 10
11176538|NCT02036775|BG000|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~Each subject received one treatment per treatment period. Each of the three treatment phases was 6 days long, where study drug was administered on day 1-5 during each treatment."
11176539|NCT02036775|FG000|Participant Flow|Lasolvan 75mg / Lasolvan 30mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
11176540|NCT02036775|FG001|Participant Flow|Lasolvan 60mg / Lasolvan 75mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
11176541|NCT02036775|FG002|Participant Flow|Lasolvan 30mg / Lasolvan 60mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
11176542|NCT02036775|FG003|Participant Flow|Lasolvan 60mg / Lasolvan 30mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
11176543|NCT02036775|FG004|Participant Flow|Lasolvan 30mg / Lasolvan 75mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
11176544|NCT02036775|FG005|Participant Flow|Lasolvan 75mg / Lasolvan 60mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
11176545|NCT02036775|OG000|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
11176546|NCT02036775|OG001|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
11176547|NCT02036775|OG002|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
11176548|NCT02036775|EG000|Reported Event|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
11176549|NCT02036775|EG001|Reported Event|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
11176550|NCT02036775|EG002|Reported Event|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
11176551|NCT02036840|BG000|Baseline|Penicillin Allergy|Antibiotic
10936409|NCT00741260|BG003|Baseline|N200 + C2000|Neratinib 200 mg + Capecitabine 2000 mg/sq m
10936410|NCT00741260|BG004|Baseline|N160 + C2000|Neratinib 160 mg + Capecitabine 2000 mg/sq m
10936411|NCT00741260|BG005|Baseline|N + C MTD - No Prior Lap|Neratinib + Capecitabine MTD (No prior Lapatinib)
10936412|NCT00741260|BG006|Baseline|N + C MTD - Prior Lap|Neratinib + Capecitabine MTD (Prior Lapatinib)
10936413|NCT00741260|BG007|Baseline|Total|Total of all reporting groups
10936414|NCT00741260|FG000|Participant Flow|N160 + C1500|Neratinib 160 mg + Capecitabine 1500 mg/sq m
11176552|NCT02036840|FG000|Participant Flow|Penicillin Allergy|Antibiotic
11176553|NCT02036840|OG000|Outcome|Penicillin Allergy|Antibiotic
11176554|NCT02036840|EG000|Reported Event|Penicillin Allergy|Antibiotic
11192128|NCT02137382|FG000|Participant Flow|Sequence: Creon N/Creon®|Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
11234206|NCT02432703|BG001|Baseline|JNJ-42165279 25 mg|Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
10936415|NCT00741260|FG001|Participant Flow|N240 + C1500|Neratinib 240 mg + Capecitabine 1500 mg/sq m
10936416|NCT00741260|FG002|Participant Flow|N240 + C2000|Neratinib 240 mg + Capecitabine 2000 mg/sq m
10936417|NCT00741260|FG003|Participant Flow|N200 + C2000|Neratinib 200 mg + Capecitabine 2000 mg/sq m
10936418|NCT00741260|FG004|Participant Flow|N160 + C2000|Neratinib 160 mg + Capecitabine 2000 mg/sq m
10936419|NCT00741260|FG005|Participant Flow|N + C MTD - No Prior Lap|Neratinib + Capecitabine MTD (No prior Lapatinib)
10936420|NCT00741260|FG006|Participant Flow|N + C MTD - Prior Lap|Neratinib + Capecitabine MTD (Prior Lapatinib)
11176555|NCT02036853|BG000|Baseline|Schedule A|"Subjects previously treated with triheptanoin~Triheptanoin: Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
10936421|NCT00741260|OG000|Outcome|N160 + C1500|Neratinib 160 mg + Capecitabine 1500 mg/m2
10936422|NCT00741260|OG001|Outcome|N160 + C2000|Neratinib 160 mg + Capecitabine 2000 mg/m2
10936423|NCT00741260|OG002|Outcome|N200 + C2000|Neratinib 200 mg + Capecitabine 2000 mg/m2
10936424|NCT00741260|OG003|Outcome|N240 + C1500|Neratinib 240 mg + Capecitabine 1500 mg/m2
10936425|NCT00741260|OG004|Outcome|N240 + C2000|Neratinib 240 mg + Capecitabine 2000 mg/m2
11176556|NCT02036853|BG001|Baseline|Schedule B|"Naïve to triheptanoin~Triheptanoin: Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
10936426|NCT00741260|OG005|Outcome|N + C MTD - No Prior Lap|Neratinib + Capecitabine MTD (No prior Lapatinib)
10936427|NCT00741260|OG006|Outcome|N + C MTD - Prior Lap|Neratinib + Capecitabine MTD (Prior Lapatinib)
10936428|NCT00741260|OG000|Outcome|Prior Lapatinib Subjects|MTD (Part 2), Subjects with Prior Lapatinib Experience
10936429|NCT00741260|OG001|Outcome|Lapatinib Naive Subjects P1|MTD (Part 2), Subjects without Prior Lapatinib Experience
10936430|NCT00741260|OG002|Outcome|Lapatinib Naive Subjects Part 2 + Part 1|MTD (Part 2 + Part 1), Subjects without Prior Lapatinib Experience
10936431|NCT00741260|OG000|Outcome|Neratinib in Combination With Capecitabine|Oral Neratinib administered daily in combination with capecitabine orally on days 1-14 of each 21 day cycle
10936432|NCT00741260|OG000|Outcome|Capecitabine in Combination With Neratinib|Oral Neratinib administered daily in combination with capecitabine orally on days 1-14 of each 21 day cycle
10936433|NCT00741260|EG000|Reported Event|N160 + C1500|Neratinib 160 mg + Capecitabine 1500 mg/m2
10936434|NCT00741260|EG001|Reported Event|N240 + C1500|Neratinib 240 mg + Capecitabine 1500 mg/m2
10936435|NCT00741260|EG002|Reported Event|N240 + C2000|Neratinib 240 mg + Capecitabine 2000 mg/m2
10936436|NCT00741260|EG003|Reported Event|N200 + C2000|Neratinib 200 mg + Capecitabine 2000 mg/m2
10936437|NCT00741260|EG004|Reported Event|N160 + C2000|Neratinib 160 mg + Capecitabine 2000 mg/m2
10936438|NCT00741260|EG005|Reported Event|N + C MTD - No Prior Lap|Neratinib + Capecitabine MTD (No prior Lapatinib)
10936439|NCT00741260|EG006|Reported Event|N + C MTD - Prior Lap|Neratinib + Capecitabine MTD (Prior Lapatinib)
10936440|NCT00741273|BG000|Baseline|Healthy|Healthy females
10936441|NCT00741273|BG001|Baseline|Mpaired|Hepatically impaired females
10936442|NCT00741273|BG002|Baseline|Total|Total of all reporting groups
10936443|NCT00741273|FG000|Participant Flow|Healthy|Proellex single dose each of 25 mg and 50 mg in healthy females
10936444|NCT00741273|FG001|Participant Flow|Impaired|Proellex single dose each of 25 mg and 50 mg in hepatically impaired females
10936445|NCT00741273|OG000|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
10936446|NCT00741273|OG001|Outcome|Proellex 25 mg Impaired|"Proellex 50 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
10936447|NCT00741273|OG002|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
10936448|NCT00741273|OG003|Outcome|Proellex 50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
10936449|NCT00741273|OG001|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
10936450|NCT00741273|OG003|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
10936451|NCT00741273|EG000|Reported Event|Proellex Healthy|"Proellex 25 mg and 50 mg in healthy females~Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
10936452|NCT00741273|EG001|Reported Event|Proellex Impaired|"Proellex 25 mg and 50 mg in hepatically impaired females~Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
10936453|NCT00741286|BG000|Baseline|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
10936454|NCT00741286|BG001|Baseline|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
10936455|NCT00741286|BG002|Baseline|Total|Total of all reporting groups
10936456|NCT00741286|FG000|Participant Flow|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
10936457|NCT00741286|FG001|Participant Flow|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
10936458|NCT00741286|OG000|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
10936459|NCT00741286|OG001|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
10936460|NCT00741286|EG000|Reported Event|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
10936461|NCT00741286|EG001|Reported Event|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
11176557|NCT02036853|BG002|Baseline|Total|Total of all reporting groups
11176558|NCT02036853|FG000|Participant Flow|Schedule A|"Subjects previously treated with triheptanoin~Triheptanoin: Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
10936462|NCT00741338|BG000|Baseline|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
10936463|NCT00741338|BG001|Baseline|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
10936464|NCT00741338|BG002|Baseline|Total|Total of all reporting groups
10936465|NCT00741338|FG000|Participant Flow|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
10936466|NCT00741338|FG001|Participant Flow|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
10936467|NCT00741338|OG000|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
10936468|NCT00741338|OG001|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
10936469|NCT00741338|EG000|Reported Event|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
11176559|NCT02036853|FG001|Participant Flow|Schedule B|"Naïve to triheptanoin~Triheptanoin: Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
11176560|NCT02036853|OG000|Outcome|Schedule A|"Subjects previously treated with triheptanoin~Triheptanoin: Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
10936470|NCT00741338|EG001|Reported Event|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low- dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
10936471|NCT00741390|BG000|Baseline|Entire Study Population|
10936472|NCT00741390|FG000|Participant Flow|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G. The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm A are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips. For Visit 2 only the BD/33G and OTM/28G were used.
10936473|NCT00741390|FG001|Participant Flow|Arm B|Visit 1 (V1):BD/33G,OTM/33G,OTU/28G; Visit 2 (V2):BD/33G, OTU/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing).The lancet/lancing device combinations assigned to Arm B are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTU/28G (OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the BD/33G and OTU/28G were used.
10936474|NCT00741390|FG002|Participant Flow|Arm C|Visit 1 (V1): BD/33G, OTM/33G,ACC/28G Visit 2 (V2): BD/33G, ACC/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm C are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: ACC/28G (Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip). For Visit 2 only the BD/33G and ACC/28G were used.
10936475|NCT00741390|FG003|Participant Flow|Arm D|Visit1 (V1): BD/33G,OTM/33G,OTM/28G; V2: OTM/33G, OTM/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm D are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the OTM/33G and OTM/28G were used.
10936476|NCT00741390|OG000|Outcome|BD/33G|"BD Lancet Device / BD 33 Gauge Lancet.~In Study Visit 1 each subject was randomly assigned to one of four groups, each subject evaluated three different lancet device/lancet combinations. The order of evaluation of the three systems was randomly assigned for each subject. Subjects started at the middle depth setting of each lancet device. The lowest depth setting for each system yielding sufficient volume for each system was recorded for that subject and used during Visit 2. All subjects whom obtained adequate sample volumes were selected to participate in Study Visit 2."
10936477|NCT00741390|OG001|Outcome|OTM/33G|"OneTouch Mini Device / BD 33 Gauge Lancet~See description for BD/33G."
10936478|NCT00741390|OG002|Outcome|OTM/28G|"OneTouch Mini Device / OneTouch UltraSoft 28G Lancet~See description for BD/33G."
10936479|NCT00741390|OG003|Outcome|OTU/28G|"OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet~See description for BD/33G."
10936480|NCT00741390|OG004|Outcome|ACC/28G|"Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet~See description for BD/33G."
10936481|NCT00741390|OG000|Outcome|OTM/28G - BD/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
10936482|NCT00741390|OG001|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
10936483|NCT00741390|OG002|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device/Accu-Chek Softclix 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
10936484|NCT00741390|OG000|Outcome|OTM/28G - OTM/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to OneTouch Mini Device / BD 33G Lancet
10936485|NCT00741390|OG000|Outcome|OTM/28G - BD/33G|OneTouch Mini Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
10936486|NCT00741390|OG001|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
10936487|NCT00741390|OG002|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
10936488|NCT00741390|OG003|Outcome|OTM/28G - OTM/33G|OneTouch MiniDevice / OneTouch 28g Lancet - OneTouch MiniDevice /BD 33 Gauge Lancet
10936489|NCT00741390|EG000|Reported Event|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G
10936490|NCT00741390|EG001|Reported Event|Arm B|Visit 1 (V1) Device: BD/33G,OTM/33G,OTU/28G; Visit 2 (V2) Device: BD/33G,OTU/28G
10936491|NCT00741390|EG002|Reported Event|Arm C|Visit 1 (V1) Device: BD/33G,OTM/33G,ACC/28G; Visit 2 (V2)-BD/33G,ACC/28G
10936492|NCT00741390|EG003|Reported Event|Arm D|Visit 1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit (V2) Device: OTM/33G,OTM/28G
11234207|NCT02432703|BG002|Baseline|Total|Total of all reporting groups
10936493|NCT00741455|BG000|Baseline|Study Treatment|"Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate~Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be > 5 x 106 CD34+cells/kg of recipient.~Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.~Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.~G-CSF: 10 mcg/k"
10936494|NCT00741455|FG000|Participant Flow|Study Treatment|"Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate~Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be > 5 x 106 CD34+cells/kg of recipient.~Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.~Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.~G-CSF: 10 mcg/k"
10936495|NCT00741455|OG000|Outcome|Study Treatment|"Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate~Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be > 5 x 106 CD34+cells/kg of recipient.~Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.~Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.~G-CSF: 10 mcg/k"
10936496|NCT00741455|EG000|Reported Event|Study Treatment|"Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate~Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be > 5 x 106 CD34+cells/kg of recipient.~Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.~Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.~G-CSF: 10 mcg/k"
10936497|NCT00741468|BG000|Baseline|All Subjects|"Proellex 50 mg~Proellex: 2, 25 mg Proellex capsules administered daily"
10936498|NCT00741468|FG000|Participant Flow|All Participants|CYP1A2, Day 8 relative to Day 1 AUC (caffeine probe) CYP2C19, Day 8 relative to Day 1 AUC (omeprazole probe) CYP 2C9, Day 8 relative to Day 1 AUC (tolbutamide probe) CYP2D6, Day 8 relative to Day 1 AUC (dextromethorphan probe) CYP3A4, Day 8 relative to Day 1 AUC (midazolam probe)
10936499|NCT00741468|OG000|Outcome|CYP1A2|Day 8 relative to Day 1 AUC (caffeine probe)
10936500|NCT00741468|OG001|Outcome|CYP2C9|Day 8 relative to Day 1 AUC (tolbutamide probe)
10936501|NCT00741468|OG002|Outcome|CYP2C19|Day 8 relative to Day 1 AUC (omeprazole probe)
10936502|NCT00741468|OG003|Outcome|CYP2D6|Day 8 relative to Day 1 AUC (dextromethorphan probe)
10936503|NCT00741468|OG004|Outcome|CYP3A4|Day 8 relative to Day 1 AUC (midazolam probe)
10936504|NCT00741468|EG000|Reported Event|All Subjects|"Proellex 50 mg~Proellex: 2, 25 mg Proellex capsules administered daily"
10936505|NCT00741598|BG000|Baseline|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
11176561|NCT02036853|OG001|Outcome|Schedule B|"Naïve to triheptanoin~Triheptanoin: Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
11176562|NCT02036853|EG000|Reported Event|Schedule A|"Subjects previously treated with triheptanoin~Triheptanoin: Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
11192129|NCT02137382|FG001|Participant Flow|Sequence: Creon®/Creon N|Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
11192130|NCT02137382|OG000|Outcome|Creon®|Creon®: active comparator
10936506|NCT00741598|BG001|Baseline|Placebo|placebo equivalent
10936507|NCT00741598|BG002|Baseline|Total|Total of all reporting groups
10936508|NCT00741598|FG000|Participant Flow|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
11192131|NCT02137382|OG001|Outcome|Creon N|Creon N: experimental drug
11357636|NCT03751657|EG001|Reported Event|Insulin Glargine|Participants were to receive once daily s.c injection of Insulin glargine using 10 ml vial and syringe at a starting dose of 10 U and once weekly placebo for 26 weeks. The insulin dose was then adjusted to reach the glycaemic target of 3.9-6.0 mmol/L based on 3 pre-breakfast SMPG values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 3.0 mmol/L- dose reduced by 4 U, and 3.0-3.8 dose reduced by 2 U. Otherwise, the dose adjustment was based on the mean of SMPG values. If the mean was: 3.9-6.0 mmol/L- no adjustment; 6.1-7.0 mmol/L- dose increased by 2 U, and >7.0 mmol/L- dose increased by 4 U. All participants used metformin with or without DPP4i at the stable, pre-trial dose and at the same frequency unless due to safety concerns.
10936509|NCT00741598|FG001|Participant Flow|Placebo|placebo equivalent
10936510|NCT00741598|OG000|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
10936511|NCT00741598|OG001|Outcome|Placebo|16-week treatment with flexible doses of placebo equivalent
10936512|NCT00741598|OG001|Outcome|Placebo|placebo equivalent
10936513|NCT00741598|EG000|Reported Event|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
10936514|NCT00741598|EG001|Reported Event|Placebo|placebo equivalent
10936515|NCT00741611|BG000|Baseline|Mesh|Ablation with HD Mesh Ablation System
10936516|NCT00741611|BG001|Baseline|Drug|Treatment with anti-arrhythmic drugs
10936517|NCT00741611|BG002|Baseline|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
10936518|NCT00741611|BG003|Baseline|Total|Total of all reporting groups
10936519|NCT00741611|FG000|Participant Flow|Mesh|Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur.
10936520|NCT00741611|FG001|Participant Flow|Drug|Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
10936521|NCT00741611|FG002|Participant Flow|Roll-ins|Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization.
10936522|NCT00741611|OG000|Outcome|Mesh|Ablation with HD Mesh Ablation System
10936523|NCT00741611|OG001|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
10936524|NCT00741611|OG001|Outcome|Drug|Treatment with anti-arrhythmic drugs
10936525|NCT00741611|OG002|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
10936526|NCT00741611|EG000|Reported Event|Mesh|Ablation with HD Mesh Ablation System
10936527|NCT00741611|EG001|Reported Event|Drug|Treatment with anti-arrhythmic drugs
10936528|NCT00741611|EG002|Reported Event|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
10936529|NCT00741819|BG000|Baseline|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
10936530|NCT00741819|FG000|Participant Flow|Inhaled Treprostinil|Inhaled treprostinil was given four times daily at doses titrated up to 12 breaths.
10936531|NCT00741819|OG000|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily
10936532|NCT00741819|OG000|Outcome|Inhaled Treprostinil|Up to 12 breaths four times daily.
10936533|NCT00741819|OG000|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
10936534|NCT00741819|EG000|Reported Event|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
10936535|NCT00741858|BG000|Baseline|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
10936536|NCT00741858|BG001|Baseline|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
10936537|NCT00741858|BG002|Baseline|Total|Total of all reporting groups
10936538|NCT00741858|FG000|Participant Flow|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
10936539|NCT00741858|FG001|Participant Flow|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
10936540|NCT00741858|OG000|Outcome|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
10936541|NCT00741858|OG001|Outcome|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
10936542|NCT00741858|EG000|Reported Event|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
11192132|NCT02137382|OG000|Outcome|Creon®|Creon® : active comparator
10936543|NCT00741858|EG001|Reported Event|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
10936544|NCT00741936|BG000|Baseline|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10936545|NCT00741936|BG001|Baseline|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10936546|NCT00741936|BG002|Baseline|Total|Total of all reporting groups
10936547|NCT00741936|FG000|Participant Flow|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10936548|NCT00741936|FG001|Participant Flow|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10936549|NCT00741936|OG000|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10936550|NCT00741936|OG001|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10936551|NCT00741936|EG000|Reported Event|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10936552|NCT00741936|EG001|Reported Event|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10936553|NCT00742001|BG000|Baseline|Mirasol Illumination Dose #1 (A1)|"Whole blood units treated with Mirasol at Illumination dose #1: 22 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936554|NCT00742001|BG001|Baseline|Mirasol Illumination Dose #2 (A2)|"Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936555|NCT00742001|BG002|Baseline|Mirasol Illumination Dose #3 (A3)|"Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936556|NCT00742001|BG003|Baseline|Total|Total of all reporting groups
10936557|NCT00742001|FG000|Participant Flow|Mirasol Illumination Dose #1 (A1)|"Whole blood units treated with Mirasol at Illumination dose #1: 22 Joules per milliliter of red blood cells (J/mL RBC)~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936558|NCT00742001|FG001|Participant Flow|Mirasol Illumination Dose #2 (A2)|"Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936559|NCT00742001|FG002|Participant Flow|Mirasol Illumination Dose #3 (A3)|"Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936560|NCT00742001|OG000|Outcome|Mirasol Illumination Dose #1 (A1)|"Whole blood units treated with Mirasol at Illumination dose #1: 22 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936561|NCT00742001|OG001|Outcome|Mirasol Illumination Dose #2 (A2)|"Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936562|NCT00742001|OG002|Outcome|Mirasol Illumination Dose #3 (A3)|"Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936563|NCT00742001|OG000|Outcome|Mirasol Illumination Dose #1 (A1)|"Whole blood units treated with Mirasol at Illumination dose #1.~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936564|NCT00742001|OG001|Outcome|Mirasol Illumination Dose #2 (A2)|"Whole Blood units treated with Mirasol at Illumination dose #2.~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936565|NCT00742001|OG002|Outcome|Mirasol Illumination Dose #3 (A3)|"Whole Blood units treated with Mirasol at Illumination dose #3.~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936566|NCT00742001|EG000|Reported Event|Mirasol Illumination Dose #1 (A1)|"Whole blood units treated with Mirasol at Illumination dose #1: 22 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936567|NCT00742001|EG001|Reported Event|Mirasol Illumination Dose #2 (A2)|"Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
11192133|NCT02137382|EG000|Reported Event|Creon®|Creon®: active comparator
11192134|NCT02137382|EG001|Reported Event|Creon N|Creon N: experimental drug
10936568|NCT00742001|EG002|Reported Event|Mirasol Illumination Dose #3 (A3)|"Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC~Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects"
10936569|NCT00742027|BG000|Baseline|Panobinostat|Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
10936570|NCT00742027|FG000|Participant Flow|Panobinostat|Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
10936571|NCT00742027|OG000|Outcome|Panobinostat|Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
10936572|NCT00742027|EG000|Reported Event|Panobinostat|Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
10936573|NCT00742053|BG000|Baseline|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
10936574|NCT00742053|FG000|Participant Flow|PICC Insertion|All patients, aged 18 to 80 years, who required Peripherally inserted central catheter (PICC) insertion for their standard care will be studied.
10936575|NCT00742053|OG000|Outcome|PICC Placement|Patients who require PICC placement
10936576|NCT00742053|EG000|Reported Event|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
10936577|NCT00742079|BG000|Baseline|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
10936578|NCT00742079|BG001|Baseline|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
10936579|NCT00742079|BG002|Baseline|Total|Total of all reporting groups
10936580|NCT00742079|FG000|Participant Flow|1 D-cycloserine First, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
10936581|NCT00742079|FG001|Participant Flow|2 Placebo First, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
10936582|NCT00742079|OG000|Outcome|D-cycloserine|Participants receive 50 mg of D-cycloserine
10936583|NCT00742079|OG001|Outcome|Placebo|Participants receive 50 mg of placebo
10936584|NCT00742079|EG000|Reported Event|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
10936585|NCT00742079|EG001|Reported Event|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
10936586|NCT00742170|BG000|Baseline|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
10936587|NCT00742170|BG001|Baseline|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
10936588|NCT00742170|BG002|Baseline|Total|Total of all reporting groups
10936589|NCT00742170|FG000|Participant Flow|Active Electroacupuncture Condition|"Active electroacupuncture condition~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
10936590|NCT00742170|FG001|Participant Flow|Sham Electroacupuncture Condition|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
11192135|NCT02137447|BG000|Baseline|Treatment Group|Negative Pressure treatment
10936591|NCT00742170|OG000|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
10936592|NCT00742170|OG001|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
10936593|NCT00742170|EG000|Reported Event|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
10936594|NCT00742170|EG001|Reported Event|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
10936595|NCT00742183|BG000|Baseline|Mepilex® Ag|The dressing to be used Mepilex® Ag, consists of an absorbent polyurethane foam pad containing silver sulphate with a silicone contact layer with the Safetac® technology. The silver ions are hydro activated in presence of fluid or wound exudates.
10936596|NCT00742183|BG001|Baseline|Silvadene® Cream 1%|Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second-and third-degree burns.
10936597|NCT00742183|BG002|Baseline|Total|Total of all reporting groups
11234208|NCT02432703|FG000|Participant Flow|Placebo|Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.
10936598|NCT00742183|FG000|Participant Flow|Mepilex Ag|"Treatment period will be a maximum of three weeks with Silvadene® or Mepilex® Ag.~Dressing changes of Mepilex® Ag will be performed every 5-7 day, depending on the status of the burn"
10936599|NCT00742183|FG001|Participant Flow|Silvadene|Silver sulfadiazine 1% cream treatment period will be a maximum of three weeks. Dressing changes of Silvadene® will be performed at least once per day.
10936600|NCT00742183|OG000|Outcome|Mepilex Ag|Patients with a second degree burn covering 5% to 20% BSA. TBSA covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the Second degree burn should be treated).
10936601|NCT00742183|OG001|Outcome|Silvadene|Patients with a second degree burn covering 5% to 20% BSA. TBSA covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the Second degree burn should be treated).
10936602|NCT00742183|EG000|Reported Event|Mepilex Ag|Mepilex® Ag is an antimicrobial soft silicone foam dressing that absorbs exudate and maintains a moist wound environment.
10936603|NCT00742183|EG001|Reported Event|Silvadene|Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug.
10936604|NCT00742209|BG000|Baseline|Placebo|Oral GEn (XP13512) placebo on Weeks 1-17
10936605|NCT00742209|BG001|Baseline|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
10936606|NCT00742209|BG002|Baseline|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day.
10936607|NCT00742209|BG003|Baseline|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day.
10936608|NCT00742209|BG004|Baseline|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
10936609|NCT00742209|BG005|Baseline|Total|Total of all reporting groups
10936610|NCT00742209|FG000|Participant Flow|Placebo|Oral GEn (XP13512) placebo
10936611|NCT00742209|FG001|Participant Flow|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
10936612|NCT00742209|FG002|Participant Flow|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
10936613|NCT00742209|FG003|Participant Flow|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
10936614|NCT00742209|FG004|Participant Flow|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
10936615|NCT00742209|OG000|Outcome|Placebo|Oral GEn (XP13512) placebo
10936616|NCT00742209|OG001|Outcome|Average of GEn 1800/2400 mg|Average of GEn 1800 mg group and GEn 2400 mg group
10936617|NCT00742209|OG002|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
10936618|NCT00742209|OG003|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
10936619|NCT00742209|OG001|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
10936620|NCT00742209|OG004|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
10936621|NCT00742209|EG000|Reported Event|Placebo|Oral GEn (XP13512) placebo
10936622|NCT00742209|EG001|Reported Event|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
10936623|NCT00742209|EG002|Reported Event|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
10936624|NCT00742209|EG003|Reported Event|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
10936625|NCT00742209|EG004|Reported Event|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
10936626|NCT00742235|BG000|Baseline|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
10936627|NCT00742235|BG001|Baseline|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
10936628|NCT00742235|BG002|Baseline|Total|Total of all reporting groups
10936629|NCT00742235|FG000|Participant Flow|Vitamin D Sufficient|Subjects not treated with ergocalciferol and who had 25-OH vitamin D > 32 ng/ml.
10936630|NCT00742235|FG001|Participant Flow|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL who were offered ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total)
10936631|NCT00742235|OG000|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
10936632|NCT00742235|OG001|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
10936633|NCT00742235|EG000|Reported Event|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
10936634|NCT00742235|EG001|Reported Event|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
10936635|NCT00742274|BG000|Baseline|TAG Device + Best Medical Therapy (BMT)|
10936636|NCT00742274|BG001|Baseline|BEST MEDICAL THERAPY (BMT) Alone|
10936637|NCT00742274|BG002|Baseline|Total|Total of all reporting groups
10936638|NCT00742274|FG000|Participant Flow|TAG Device + Best Medical Therapy (BMT)|TAG+BMT
10936639|NCT00742274|FG001|Participant Flow|Best Medical Therapy (BMT) Alone|BMT alone
10936640|NCT00742274|OG000|Outcome|TAG Device + Best Medical Therapy (BMT)|
10936641|NCT00742274|OG001|Outcome|BEST MEDICAL THERAPY (BMT) Alone|
10936642|NCT00742274|EG000|Reported Event|TAG Device + Best Medical Therapy (BMT)|
10936643|NCT00742274|EG001|Reported Event|BEST MEDICAL THERAPY (BMT) Alone|
10936644|NCT00742313|BG000|Baseline|FloSeal|Arm A has FloSeal Matrix applied to EVH wound bed.
10936645|NCT00742313|BG001|Baseline|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
10936646|NCT00742313|BG002|Baseline|Total|Total of all reporting groups
10936647|NCT00742313|FG000|Participant Flow|FloSeal Matrix|FloSeal Matrix applied to EVH wound bed.
10936648|NCT00742313|FG001|Participant Flow|Non-FloSeal Matrix|FloSeal Matrix was not added to the wound bed
10936649|NCT00742313|OG000|Outcome|FloSeal Matrix|Arm A has FloSeal Matrix applied to EVH wound bed.
10936650|NCT00742313|OG001|Outcome|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
10936651|NCT00742313|EG000|Reported Event|Arm A|Arm A has FloSeal Matrix applied to EVH wound bed.
10936652|NCT00742313|EG001|Reported Event|Arm B|Arm B does not have FloSeal Matrix applied to EVH wound bed.
10936653|NCT00742326|BG000|Baseline|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
10936654|NCT00742326|BG001|Baseline|Placebo|Placebo once daily for 48 weeks
10936655|NCT00742326|BG002|Baseline|Total|Total of all reporting groups
10936656|NCT00742326|FG000|Participant Flow|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
10936657|NCT00742326|FG001|Participant Flow|Placebo|Placebo once daily for 48 weeks
10936658|NCT00742326|OG000|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
10936659|NCT00742326|OG001|Outcome|Placebo|Placebo once daily for 48 weeks
10936660|NCT00742326|EG000|Reported Event|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
10936661|NCT00742326|EG001|Reported Event|Placebo|Placebo once daily for 48 weeks
10936662|NCT00742391|BG000|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10936663|NCT00742391|BG001|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
10936664|NCT00742391|BG002|Baseline|Total|Total of all reporting groups
10936665|NCT00742391|FG000|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10936666|NCT00742391|FG001|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
10936667|NCT00742391|OG000|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10936668|NCT00742391|OG001|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
10936669|NCT00742391|EG000|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10936670|NCT00742391|EG001|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
10936671|NCT00742417|BG000|Baseline|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
10936672|NCT00742417|BG001|Baseline|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
10936673|NCT00742417|BG002|Baseline|Total|Total of all reporting groups
10936674|NCT00742417|FG000|Participant Flow|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
10936675|NCT00742417|FG001|Participant Flow|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
10936676|NCT00742417|OG000|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
10936677|NCT00742417|OG001|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
10936678|NCT00742417|OG001|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
10936679|NCT00742417|OG000|Outcome|Albutein 5%|"Patients allocated to this arm will undergo plasma exchange with Albutein 5%.~Albutein 5%: 18 Plasma Exchanges using~Albutein 5% or~Sham Procedure~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
10936680|NCT00742417|EG000|Reported Event|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
10936681|NCT00742417|EG001|Reported Event|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
10936682|NCT00742469|BG000|Baseline|Treatment Arm 1|Rifaximin 600 MG QD
10936683|NCT00742469|BG001|Baseline|Placebo Arm|Matching Placebo 600MG QD
10936684|NCT00742469|BG002|Baseline|Total|Total of all reporting groups
10936685|NCT00742469|FG000|Participant Flow|Treatment Arm 1|Rifaximin 600 MG QD
10936686|NCT00742469|FG001|Participant Flow|Placebo Arm|Matching Placebo 600MG QD
10936687|NCT00742469|OG000|Outcome|Treatment Arm|"Rifaximin~Rifaximin"
10936688|NCT00742469|OG001|Outcome|Placebo Arm|"Placebo~Placebo"
10936689|NCT00742469|EG000|Reported Event|Treatment Arm|Rifaximin 600 MG QD
10936690|NCT00742469|EG001|Reported Event|Placebo|Matching Placebo 600MG QD
10936691|NCT00742508|BG000|Baseline|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
10936692|NCT00742508|BG001|Baseline|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
10936693|NCT00742508|BG002|Baseline|Total|Total of all reporting groups
10936694|NCT00742508|FG000|Participant Flow|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
10936695|NCT00742508|FG001|Participant Flow|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
10936696|NCT00742508|OG000|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
10936697|NCT00742508|OG001|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
10936698|NCT00742508|EG000|Reported Event|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
10936699|NCT00742508|EG001|Reported Event|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
10936700|NCT00742560|BG000|Baseline|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936701|NCT00742560|BG001|Baseline|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936702|NCT00742560|BG002|Baseline|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936703|NCT00742560|BG003|Baseline|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936704|NCT00742560|BG004|Baseline|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936705|NCT00742560|BG005|Baseline|Total|Total of all reporting groups
10936706|NCT00742560|FG000|Participant Flow|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936707|NCT00742560|FG001|Participant Flow|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936708|NCT00742560|FG002|Participant Flow|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936709|NCT00742560|FG003|Participant Flow|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936710|NCT00742560|FG004|Participant Flow|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936711|NCT00742560|OG000|Outcome|Phase 1 Elotuzumab + Lenalidomide and Dexamethasone|Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936712|NCT00742560|OG000|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
10936713|NCT00742560|OG001|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936714|NCT00742560|OG002|Outcome|Total (Phase 2)|Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936715|NCT00742560|OG000|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
11234209|NCT02432703|FG001|Participant Flow|JNJ-42165279 25 mg|Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
10936716|NCT00742560|OG001|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936717|NCT00742560|OG002|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
10936718|NCT00742560|OG003|Outcome|Total (Phase 1)|Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936719|NCT00742560|OG002|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936720|NCT00742560|OG003|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936721|NCT00742560|OG004|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936722|NCT00742560|OG000|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
10936723|NCT00742560|OG001|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
10936724|NCT00742560|OG002|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
10936725|NCT00742560|OG000|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
10936726|NCT00742560|OG001|Outcome|Elotuzumab 5 mg/kg Administered as an IV Infusion in Combinati|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
10936727|NCT00742560|OG004|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936728|NCT00742560|OG005|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
11357637|NCT03751280|BG000|Baseline|PEAR-004|Eligible participants were to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life.
10936729|NCT00742560|OG006|Outcome|Total (Phase 2)|Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
10936730|NCT00742560|OG006|Outcome|Total (Phase 2)|Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936731|NCT00742560|OG005|Outcome|Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936732|NCT00742560|OG000|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936733|NCT00742560|OG001|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936734|NCT00742560|OG002|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936735|NCT00742560|EG000|Reported Event|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936736|NCT00742560|EG001|Reported Event|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936737|NCT00742560|EG002|Reported Event|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936738|NCT00742560|EG003|Reported Event|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936739|NCT00742560|EG004|Reported Event|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
10936740|NCT00742573|BG000|Baseline|1 Texas Medication Algorithm|"Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression~Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine."
10936741|NCT00742573|BG001|Baseline|2 Patient Choice|"Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression~Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.~Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems."
10936742|NCT00742573|BG002|Baseline|Total|Total of all reporting groups
10936743|NCT00742573|FG000|Participant Flow|1 Texas Medication Algorithm|"Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression~Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine."
10936744|NCT00742573|FG001|Participant Flow|2 Patient Choice|"Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression~Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.~Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems."
10936745|NCT00742573|OG000|Outcome|1 Texas Medication Algorithm|"Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression~Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine."
10936746|NCT00742573|OG001|Outcome|2 Patient Choice|"Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression~Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.~Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems."
10936747|NCT00742573|EG000|Reported Event|1 Texas Medication Algorithm|"Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression~Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine."
10936748|NCT00742573|EG001|Reported Event|2 Patient Choice|"Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression~Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.~Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems."
10936749|NCT00742625|BG000|Baseline|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
10936750|NCT00742625|FG000|Participant Flow|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
10936751|NCT00742625|OG000|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
10936752|NCT00742625|OG000|Outcome|Bortezomib (0.7 mg/m^2) + Int-DAC|Bortezomib (0.7 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
10936753|NCT00742625|OG001|Outcome|Bortezomib (1.0 mg/m^2) + Int-DAC|Bortezomib (1.0 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
10936754|NCT00742625|OG002|Outcome|Bortezomib (1.3 mg/m^2) + Int-DAC|Bortezomib (1.3 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
10936755|NCT00742625|EG000|Reported Event|Bortezomib + Daunorubicin + Cytarabine|Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
10936756|NCT00742781|BG000|Baseline|Vitamin D Supplementation|
10936757|NCT00742781|FG000|Participant Flow|Vitamin D Supplementation|
10936758|NCT00742781|OG000|Outcome|Baseline|
10936759|NCT00742781|OG001|Outcome|Vitamin D Supplemented|
10936760|NCT00742781|EG000|Reported Event|Vitamin D Supplemented|
10936761|NCT00742859|BG000|Baseline|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
10936762|NCT00742859|BG001|Baseline|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
10936763|NCT00742859|BG002|Baseline|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
10936764|NCT00742859|BG003|Baseline|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
10936765|NCT00742859|BG004|Baseline|Total|Total of all reporting groups
10936766|NCT00742859|FG000|Participant Flow|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
10936767|NCT00742859|FG001|Participant Flow|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
10936768|NCT00742859|FG002|Participant Flow|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
10936769|NCT00742859|FG003|Participant Flow|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
10936770|NCT00742859|OG000|Outcome|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
10936771|NCT00742859|OG001|Outcome|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
10936772|NCT00742859|OG002|Outcome|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
10936773|NCT00742859|OG003|Outcome|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
10936774|NCT00742859|EG000|Reported Event|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
10936775|NCT00742859|EG001|Reported Event|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
10936776|NCT00742859|EG002|Reported Event|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
10936777|NCT00742859|EG003|Reported Event|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
10936778|NCT00742872|BG000|Baseline|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
10936779|NCT00742872|BG001|Baseline|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
10936780|NCT00742872|BG002|Baseline|Total|Total of all reporting groups
10936781|NCT00742872|FG000|Participant Flow|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
10936782|NCT00742872|FG001|Participant Flow|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
10936783|NCT00742872|OG000|Outcome|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
10936784|NCT00742872|OG001|Outcome|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
10936785|NCT00742872|EG000|Reported Event|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
10936786|NCT00742872|EG001|Reported Event|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
10936787|NCT00742885|BG000|Baseline|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936788|NCT00742885|BG001|Baseline|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936789|NCT00742885|BG002|Baseline|Total|Total of all reporting groups
10936790|NCT00742885|FG000|Participant Flow|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936791|NCT00742885|FG001|Participant Flow|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936792|NCT00742885|OG000|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936793|NCT00742885|OG001|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936794|NCT00742885|OG000|Outcome|Influenza A (H5N1) 20-40 Years Group.|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936795|NCT00742885|OG001|Outcome|Influenza A (H5N1) 41-64 Years Group.|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936796|NCT00742885|OG001|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm
10936797|NCT00742885|EG000|Reported Event|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936798|NCT00742885|EG001|Reported Event|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
10936799|NCT00742924|BG000|Baseline|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936800|NCT00742924|BG001|Baseline|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936801|NCT00742924|BG002|Baseline|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936802|NCT00742924|BG003|Baseline|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936803|NCT00742924|BG004|Baseline|Total|Total of all reporting groups
10936804|NCT00742924|FG000|Participant Flow|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936805|NCT00742924|FG001|Participant Flow|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936806|NCT00742924|FG002|Participant Flow|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936807|NCT00742924|FG003|Participant Flow|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
11234210|NCT02432703|OG000|Outcome|Placebo|Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.
10936808|NCT00742924|OG000|Outcome|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936809|NCT00742924|OG001|Outcome|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936810|NCT00742924|OG002|Outcome|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936811|NCT00742924|OG003|Outcome|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936812|NCT00742924|EG000|Reported Event|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936813|NCT00742924|EG001|Reported Event|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936814|NCT00742924|EG002|Reported Event|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
11234211|NCT02432703|OG001|Outcome|JNJ-42165279 25 mg|Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
10936815|NCT00742924|EG003|Reported Event|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
10936816|NCT00742963|BG000|Baseline|TH-302 in Combination With Doxorubicin|"75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.~TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Dose escalation dose levels:~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
10936817|NCT00742963|FG000|Participant Flow|TH-302 in Combination With Doxorubicin|"75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.~TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Dose escalation dose levels:~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
10936818|NCT00742963|OG000|Outcome|TH-302 in Combination With Doxorubicin|"75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.~TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Dose escalation dose levels:~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
10936819|NCT00742963|EG000|Reported Event|TH-302 in Combination With Doxorubicin|"75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.~TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Dose escalation dose levels:~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
10936820|NCT00743093|BG000|Baseline|Acetaminophen Arm|acetaminophen 500 mg
10936821|NCT00743093|BG001|Baseline|Placebo Arm|placebo
10936822|NCT00743093|BG002|Baseline|Total|Total of all reporting groups
10936823|NCT00743093|FG000|Participant Flow|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
10936824|NCT00743093|FG001|Participant Flow|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
10936825|NCT00743093|OG000|Outcome|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
10936826|NCT00743093|OG001|Outcome|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
10936827|NCT00743093|EG000|Reported Event|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
10936828|NCT00743093|EG001|Reported Event|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
10936829|NCT00743106|BG000|Baseline|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
10936830|NCT00743106|BG001|Baseline|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
10936831|NCT00743106|BG002|Baseline|Total|Total of all reporting groups
10936832|NCT00743106|FG000|Participant Flow|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
10936833|NCT00743106|FG001|Participant Flow|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
10936834|NCT00743106|OG000|Outcome|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
10936835|NCT00743106|OG001|Outcome|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
10936836|NCT00743106|EG000|Reported Event|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
10936837|NCT00743106|EG001|Reported Event|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
10936838|NCT00743119|BG000|Baseline|Overall Number of Baseline Participants|34 participants were enrolled, but only 30 participants completed. Out of the additional 4 volunteers, 1 discontinued for personal reasons and three were unreliable.
10936839|NCT00743119|FG000|Participant Flow|Placebo/Dronabinol + Marijuana|During each session, one capsule containing placebo or dronabinol (10 mg or 20 mg) was administered to the participant 45 min before marijuana was smoked (0, 1.98, or 3.56% THC marijuana). Only one active dose of marijuana or dronabinol was administered within a session. A within-subject design was used in which all participants received all strengths of dronabinol and marijuana. The order was randomized.
10936840|NCT00743119|OG000|Outcome|High Dose Dronabinol + Inactive Marijuana|Dronabinol 20 mg + inactive marijuana (0%THC)
10936841|NCT00743119|OG001|Outcome|Low Dose Dronabinol + Inactive Marijuana|10mg Dronabinol + inactive Marijuana (0% THC)
10936842|NCT00743119|OG002|Outcome|Placebo + Low THC Marijuana|Placebo + Marijuana (1.98% THC)
10936843|NCT00743119|OG003|Outcome|Placebo + High THC Marijuana|Placebo + high dose Marijuana (3.56% THC)
10936844|NCT00743119|OG004|Outcome|Placebo + Inactive Marijuana 0% THC|Placebo + inactive marijuana (0% THC)
10936845|NCT00743119|EG000|Reported Event|Placebo + Marijuana (0% THC)|Adverse events recorded during Placebo (PBO) + Marijuana (0% THC) treatment
10936846|NCT00743119|EG001|Reported Event|Dronabinol 10 mg + Marijuana (0% THC)|Adverse events recorded during Dronabinol 10 mg + Marijuana (0% THC) treatment
10936847|NCT00743119|EG002|Reported Event|Dronabinol 20mg + Marijuana (0% THC)|Adverse events recorded during Dronabinol 20mg + Marijuana (0% THC) treatment
10936848|NCT00743119|EG003|Reported Event|Placebo + Marijuana (1.98% THC)|Adverse events recorded during placebo + Marijuana (1.98% THC) treatment
10936849|NCT00743119|EG004|Reported Event|Placebo + Marijuana (3.56% THC)|Adverse events recorded during Placebo + Marijuana (3.56% THC) treatment
10936850|NCT00743145|BG000|Baseline|Placebo, Naltrexone, Marijuana|During each of the 8 outpatient sessions, participants smoked a total of 6 puffs from 3 marijuana cigarettes (2 puffs from each cigarette). Marijuana administration occurred 45 minutes after capsule administration. The number of active versus inactive cigarettes smoked during each session varied, according to active puff conditions (i.e., 0 puffs = 3 inactive cigarettes; 2 puffs = 1 active + 2 inactive cigarette; 4 puffs = 2 active + 1 inactive cigarette; 6 puffs = 3 active + 0 inactive cigarette). Cigarettes were color coded, indicating the order in which they were to be smoked and active cigarettes were always smoked before inactive. A within-subject design was used in which all participants were exposed to each of the puff conditions in combination with naltrexone or placebo. The order of naltrexone dosing and puff condition was randomized within the session and across participants.
10936851|NCT00743145|FG000|Participant Flow|Placebo, Naltrexone, Marijuana|A total of 23 participants enrolled but only 19 completed. All patients participated in all conditions; they were randomized to placebo or naltrexone treatment in a counterbalanced fashion, and underwent all smoking conditions in separate, counterbalanced sessions.
10936852|NCT00743145|OG000|Outcome|Placebo Naltrexone + Inactive Marijuana|"Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.~Inactive Marijuana (0% THC): Marijuana cigarette containing 0% THC~Placebo naltrexone: Naltrexone (0mg)"
10936853|NCT00743145|OG001|Outcome|Placebo Naltrexone + Active Marijuana (5.5% THC)|"Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.~Active Marijuana (5.5% THC): Marijuana cigarette containing 5.5% THC~Placebo naltrexone: Naltrexone (0mg)"
10936854|NCT00743145|OG002|Outcome|Placebo Naltrexone + Active Marijuana (6.2% THC)|"Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.~Active Marijuana (6.2% THC): Marijuana cigarette containing 6.2% THC~Placebo naltrexone: Naltrexone (0mg)"
10936855|NCT00743145|OG003|Outcome|Naltrexone + Active Marijuana (5.5% THC)|"Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.~Active Marijuana (5.5% THC): Marijuana cigarette containing 5.5% THC~Naltrexone: Naltrexone (12mg/70kg)"
10936856|NCT00743145|OG004|Outcome|Naltrexone + Active Marijuana (6.2% THC)|"Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.~Active Marijuana (6.2% THC): Marijuana cigarette containing 6.2% THC~Naltrexone: Naltrexone (12mg/70kg)"
10936857|NCT00743145|OG005|Outcome|Naltrexone + Inactive Marijuana|"Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.~Inactive Marijuana (0% THC): Marijuana cigarette containing 0% THC~Naltrexone: Naltrexone (12mg/70kg)"
10936858|NCT00743145|EG000|Reported Event|Placebo Naltrexone + Inactive Marijuana (0.0% THC)|0mg naltrexone + 0.0% THC marijuana
10936859|NCT00743145|EG001|Reported Event|Placebo Naltrexone + Active Marijuana (5.5% THC)|0mg naltrexone + 5.5% THC marijuana
10936860|NCT00743145|EG002|Reported Event|Placebo Naltrexone + Active Marijuana (6.2% THC)|0mg naltrexone + 6.2% THC marijuana
10936861|NCT00743145|EG003|Reported Event|Naltrexone + Inactive Marijuana (0.0% THC)|12mg naltrexone + 0.0% THC marijuana
10936862|NCT00743145|EG004|Reported Event|Naltrexone + Active Marijuana (5.5% THC)|12mg naltrexone + 5.5% THC marijuana
10936863|NCT00743145|EG005|Reported Event|Naltrexone + Active Marijuana (6.2% THC)|12mg naltrexone + 6.2% THC marijuana
10936864|NCT00743249|BG000|Baseline|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
10936865|NCT00743249|BG001|Baseline|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
10936866|NCT00743249|BG002|Baseline|Total|Total of all reporting groups
10936867|NCT00743249|FG000|Participant Flow|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
10936868|NCT00743249|FG001|Participant Flow|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
10936869|NCT00743249|OG000|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
10936870|NCT00743249|OG001|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
10936871|NCT00743249|EG000|Reported Event|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
10936872|NCT00743249|EG001|Reported Event|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
10936873|NCT00743262|BG000|Baseline|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
10936874|NCT00743262|FG000|Participant Flow|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
10936875|NCT00743262|OG000|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
10936876|NCT00743262|EG000|Reported Event|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
10936877|NCT00743275|BG000|Baseline|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
10936878|NCT00743275|BG001|Baseline|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
10936879|NCT00743275|BG002|Baseline|Total|Total of all reporting groups
10936880|NCT00743275|FG000|Participant Flow|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
10936881|NCT00743275|FG001|Participant Flow|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
10936882|NCT00743275|OG000|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
10936883|NCT00743275|OG001|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
10936884|NCT00743275|EG000|Reported Event|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
10936885|NCT00743275|EG001|Reported Event|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
10936886|NCT00743288|BG000|Baseline|Melphalan and Panobinostat (LBH589)|"Schedule A: 10mg/daily of LBH589 per orem (PO) on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
10936887|NCT00743288|FG000|Participant Flow|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
10936888|NCT00743288|FG001|Participant Flow|Melphalan and Panobinostat Schedule B1|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
10936889|NCT00743288|FG002|Participant Flow|Melphalan and Panobinostat Schedule B2|20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
10936890|NCT00743288|FG003|Participant Flow|Melphalan and Panobinostat Schedule C|20 mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
10936891|NCT00743288|FG004|Participant Flow|Melphalan and Panobinostat Schedule D1|15 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
10936892|NCT00743288|FG005|Participant Flow|Melphalan and Panobinostat Schedule D2|15 mg/daily of LBH589 PO and melphalan PO at 0.10 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
10936893|NCT00743288|FG006|Participant Flow|Melphalan and Panobinostat Schedule D3|20 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
10936894|NCT00743288|OG000|Outcome|Melphalan and Panobinostat Schedule B|"B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.~B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1."
10936895|NCT00743288|OG000|Outcome|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
10936896|NCT00743288|OG000|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
10936897|NCT00743288|OG000|Outcome|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
10936898|NCT00743288|OG001|Outcome|Melphalan and Panobinostat Schedule B|"Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.~B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1"
10936899|NCT00743288|OG002|Outcome|Melphalan and Panobinostat Schedule C|0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
10936900|NCT00743288|OG003|Outcome|Melphalan and Panobinostat Schedule D|"Schedules D1, D2 and D3~D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1"
10936901|NCT00743288|OG004|Outcome|Melphalan and Panobinostat All Patients|Data for all patients irrespective of dosage
10936902|NCT00743288|EG000|Reported Event|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
10936903|NCT00743340|BG000|Baseline|Emtricitabine|Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
10936904|NCT00743340|FG000|Participant Flow|Emtricitabine|Emtricitabine (FTC) 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
10936905|NCT00743340|OG000|Outcome|Emtricitabine|Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
10936906|NCT00743340|EG000|Reported Event|Emtricitabine|Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
10936907|NCT00743366|BG000|Baseline|Overall Number of Baseline Participants|
10936908|NCT00743366|FG000|Participant Flow|Quetiapine (200mg/Day), Placebo|Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
10936909|NCT00743366|FG001|Participant Flow|Placebo, Quetiapine (200mg/Day)|Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
10936910|NCT00743366|OG000|Outcome|Quetiapine, Marijuana|"quetiapine's effects on marijuana withdrawal and relapse~Marijuana: 0,6.9% THC~Quetiapine: 0, 200 mg/day"
10936911|NCT00743366|OG001|Outcome|Placebo, Marijuana|
10936912|NCT00743366|EG000|Reported Event|Quetiapine (200mg/Day), Placebo|Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
10936913|NCT00743366|EG001|Reported Event|Placebo, Quetiapine (200mg/Day)|Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
10963371|NCT00871715|EG000|Reported Event|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
10963372|NCT00871715|EG001|Reported Event|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
10963373|NCT00871715|EG002|Reported Event|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
10963374|NCT00871715|EG003|Reported Event|Screened But Not Randomized|Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
11234212|NCT02432703|EG000|Reported Event|Placebo|Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.
10963375|NCT00871728|BG000|Baseline|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
10963376|NCT00871728|FG000|Participant Flow|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
10963377|NCT00871728|OG000|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
10963378|NCT00871728|EG000|Reported Event|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
10963379|NCT00871741|BG000|Baseline|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
10963380|NCT00871741|BG001|Baseline|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
10963381|NCT00871741|BG002|Baseline|Total|Total of all reporting groups
10963382|NCT00871741|FG000|Participant Flow|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
10963383|NCT00871741|FG001|Participant Flow|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
10963384|NCT00871741|OG000|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
10936914|NCT00743431|BG000|Baseline|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
10936915|NCT00743431|FG000|Participant Flow|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
10936916|NCT00743431|OG000|Outcome|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
10936917|NCT00743431|EG000|Reported Event|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
11176563|NCT02036853|EG001|Reported Event|Schedule B|"Naïve to triheptanoin~Triheptanoin: Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
11176564|NCT02037061|BG000|Baseline|Normal Saline|"Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.~Normal Saline"
11176565|NCT02037061|BG001|Baseline|Bupivacaine|"Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.~Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament."
11176566|NCT02037061|BG002|Baseline|Total|Total of all reporting groups
11176567|NCT02037061|FG000|Participant Flow|Normal Saline|"Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.~Normal Saline"
11176568|NCT02037061|FG001|Participant Flow|Bupivacaine|"Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.~Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament."
11176569|NCT02037061|OG000|Outcome|Normal Saline|"Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.~Normal Saline"
10936918|NCT00743444|BG000|Baseline|Entire Study Population|Includes groups randomized to received Drug first and Placebo first.
10936919|NCT00743444|FG000|Participant Flow|AZD3355 First, Then Placebo|65 mg drug or placebo capsules, oral, 3 single doses
10936920|NCT00743444|FG001|Participant Flow|Placebo First, Then AZD3355|65 mg drug or placebo capsules, oral, 3 single doses
10936921|NCT00743444|OG000|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
10936922|NCT00743444|OG001|Outcome|Placebo|placebo capsules, oral, 3 single doses
10936923|NCT00743444|EG000|Reported Event|AZD3355|65 mg drug capsules, oral, 3 single doses
10936924|NCT00743444|EG001|Reported Event|Placebo|placebo capsules, oral, 3 single doses
10936925|NCT00743483|BG000|Baseline|BSSL|Bucelipase alfa (INN): oral suspension, 170 mg BSSL, 3 times daily for 5-6 days
10936926|NCT00743483|FG000|Participant Flow|rhBSSL|Oral suspension, 170 mg rhBSSL, 3 times daily for 5-6 days
10936927|NCT00743483|OG000|Outcome|rhBSSL|oral suspension, 170 mg, 3 times daily for 5-6 days
10936928|NCT00743483|EG000|Reported Event|BSSL|Oral suspension, 170 mg, 3 times daily for 5-6 days
10936929|NCT00743509|BG000|Baseline|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
10936930|NCT00743509|FG000|Participant Flow|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
10936931|NCT00743509|OG000|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
11176570|NCT02037061|OG001|Outcome|Bupivacaine|"Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.~Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament."
11176571|NCT02037061|OG000|Outcome|Normal Saline|
11176572|NCT02037061|OG001|Outcome|Bupivicaine|
11176573|NCT02037061|EG000|Reported Event|Normal Saline|"Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.~Normal Saline"
11176574|NCT02037061|EG001|Reported Event|Bupivacaine|"Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.~Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament."
11176575|NCT02037165|BG000|Baseline|50mg BI1026706/ 200mg BI1026706/Placebo/200mg Cele/150mg Preg|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence A: 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS), placebo (matching placebo to BI 1026706), 200mg Celecoxib (Cele, hard capsule), 150mg Pregabalin (Preg, hard capsule). Mode of admin.: oral with 200 mL of water.
11176576|NCT02037165|BG001|Baseline|200mg BI1026706/50mg BI1026706/200mg Cele/150mg Preg/Placebo|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence B: 200mg BI 1026706 (PfOS), 50mg BI 1026706 (PfOS), 200mg Cele (hard capsule), 150mg Preg (hard capsule), placebo (matching placebo). Mode of admin.: oral with 200 mL of water.
11176577|NCT02037165|BG002|Baseline|Placebo/150mg Preg/50mg BI1026706/200mg BI1026706/200mg Cele|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence C: placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS), 200mg Cele (hard capsule). Mode of admin.: oral with 200 mL of water.
11234213|NCT02432703|EG001|Reported Event|JNJ-42165279 25 mg|Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
10936932|NCT00743509|EG000|Reported Event|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
10936933|NCT00743574|BG000|Baseline|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
10936934|NCT00743574|FG000|Participant Flow|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
10936935|NCT00743574|OG000|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
10936936|NCT00743574|EG000|Reported Event|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
10936937|NCT00743652|BG000|Baseline|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
10936938|NCT00743652|BG001|Baseline|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
10936939|NCT00743652|BG002|Baseline|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
10936940|NCT00743652|BG003|Baseline|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
10936941|NCT00743652|BG004|Baseline|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
10936942|NCT00743652|BG005|Baseline|Total|Total of all reporting groups
10936943|NCT00743652|FG000|Participant Flow|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
10936944|NCT00743652|FG001|Participant Flow|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
10936945|NCT00743652|FG002|Participant Flow|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
10936946|NCT00743652|FG003|Participant Flow|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
10936947|NCT00743652|FG004|Participant Flow|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
10936948|NCT00743652|OG000|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
10936949|NCT00743652|OG001|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
10936950|NCT00743652|OG002|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
10936951|NCT00743652|OG000|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
10936952|NCT00743652|OG001|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
10936953|NCT00743652|OG000|Outcome|13vPnC (All Participants)|All participants 6 weeks to <5 years of age who received at least one single IM 0.5 mL dose of 13vPnC in either the infant series or the toddler dose.
10936954|NCT00743652|EG000|Reported Event|Group 1 (Infant Series)|Participants 6 weeks to <10 months of age with 0 prior doses of Prevnar received 3 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series).
10936955|NCT00743652|EG001|Reported Event|Group 2 (Infant Series)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series)
10936956|NCT00743652|EG002|Reported Event|Group 3 (Infant Series)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series)
10936957|NCT00743652|EG003|Reported Event|Group 1 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
10936958|NCT00743652|EG004|Reported Event|Group 2 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
10936959|NCT00743652|EG005|Reported Event|Group 3 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
10936960|NCT00743652|EG006|Reported Event|Group 4 (2 Catch-Up Doses)|Participants ≥12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
10936961|NCT00743652|EG007|Reported Event|Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
10936962|NCT00743717|BG000|Baseline|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
10936963|NCT00743717|BG001|Baseline|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
10936964|NCT00743717|BG002|Baseline|Total|Total of all reporting groups
10936965|NCT00743717|FG000|Participant Flow|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
10936966|NCT00743717|FG001|Participant Flow|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
10936967|NCT00743717|OG000|Outcome|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
10936968|NCT00743717|OG001|Outcome|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
11176578|NCT02037165|BG003|Baseline|200mg Cele/Placebo/150mg Preg/50mg BI1026706/200mg BI1026706|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence D: 200mg Cele (hard capsule), placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
11176579|NCT02037165|BG004|Baseline|150mg Preg/200mg Cele/200mg BI1026706/Placebo/50mg BI1026706|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence E: 150mg Preg (hard capsule), 200mg Cele (hard capsule), 200mg BI 1026706 (hard capsule), placebo (matching placebo), 50mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
11176580|NCT02037165|BG005|Baseline|Total|Total of all reporting groups
10936969|NCT00743717|EG000|Reported Event|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
10936970|NCT00743717|EG001|Reported Event|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
11357638|NCT03751280|BG001|Baseline|Sham|Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
11357639|NCT03751280|BG002|Baseline|Total|Total of all reporting groups
10936971|NCT00743730|BG000|Baseline|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10936972|NCT00743730|BG001|Baseline|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10936973|NCT00743730|BG002|Baseline|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
10936974|NCT00743730|BG003|Baseline|Total|Total of all reporting groups
10936975|NCT00743730|FG000|Participant Flow|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10936976|NCT00743730|FG001|Participant Flow|PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10963385|NCT00871741|OG001|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
10936977|NCT00743730|FG002|Participant Flow|Medication as Needed|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
10936978|NCT00743730|OG000|Outcome|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10936979|NCT00743730|OG001|Outcome|PNCA Without Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10936980|NCT00743730|OG002|Outcome|Intermittent Opioid on as Needed Basis|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
10936981|NCT00743730|OG002|Outcome|PRN Intermittent Opioids|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
11176581|NCT02037165|FG000|Participant Flow|50mg BI1026706/200mg BI1026706/Placebo/200mg Cele/150mg Preg|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence A: 50mg BI 1026706 (powder for oral solution [PfOS]), 200mg BI 1026706 (PfOS), placebo (matching placebo to BI 1026706), 200mg Celecoxib (Cele, hard capsule), 150mg Pregabalin (Preg, hard capsule). Mode of admin.: oral with 200 mL of water.
11176582|NCT02037165|FG001|Participant Flow|200mg BI1026706/50mg BI1026706/200mg Cele/150mg Preg/Placebo|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence B: 200mg BI 1026706 (PfOS), 50mg BI 1026706 (PfOS), 200mg Cele (hard capsule), 150mg Preg (hard capsule), placebo (matching placebo).Mode of admin.: oral with 200 mL of water.
11176583|NCT02037165|FG002|Participant Flow|Placebo/150mg Preg/50mg BI1026706/200mg BI1026706/200mg Cele|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence C: placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS), 200mg Cele (hard capsule). Mode of admin.: oral with 200 mL of water.
11176584|NCT02037165|FG003|Participant Flow|200mg Cele/Placebo/150mg Preg/50mg BI1026706/200mg BI1026706|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence D: 200mg Cele (hard capsule), placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
11176585|NCT02037165|FG004|Participant Flow|150mg Preg/200mg Cele/200mg BI1026706/Placebo/50mg BI1026706|Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence E: 150mg Preg (hard capsule), 200mg Cele (hard capsule), 200mg BI 1026706 (PfOS), placebo (matching placebo), 50mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
11176586|NCT02037165|OG000|Outcome|Placebo|Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
11176587|NCT02037165|OG001|Outcome|50 mg BI 1026706|treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
11176588|NCT02037165|OG002|Outcome|200 mg BI 1026706|treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
10936982|NCT00743730|OG000|Outcome|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10936983|NCT00743730|OG001|Outcome|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
11176589|NCT02037165|OG003|Outcome|200 mg Celecoxib (Cele)|200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
11176590|NCT02037165|OG003|Outcome|150 mg Pregabalin (Prega)|150 mg pregabalin (prega) hard capsule, single dose, mode of admin.: oral with 200 mL of water.,
11176591|NCT02037165|OG003|Outcome|200 mg Celecoxib (Cele)|200 mg celecoxib (cele) hard capsule, single dose, mode of admin.: oral with 200 mL of water.
10936984|NCT00743730|OG002|Outcome|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
10936985|NCT00743730|EG000|Reported Event|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10936986|NCT00743730|EG001|Reported Event|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
10936987|NCT00743730|EG002|Reported Event|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
10936988|NCT00744042|BG000|Baseline|Asfotase Alfa|All enrolled patients receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients begin thrice weekly SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for the remaining 23 weeks of the study.
10936989|NCT00744042|FG000|Participant Flow|Asfotase Alfa|All patients received an initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa for the first week followed by regular administration of subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times/week (total 3 mg/kg/week).
10936990|NCT00744042|OG000|Outcome|Asfotase Alfa|All HPP affected infants will receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients will then begin every other day SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for 23 weeks. End of Study will be at 24 weeks.
10936991|NCT00744042|OG000|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
10936992|NCT00744042|OG001|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
10936993|NCT00744042|OG002|Outcome|Study Week 3 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
10936994|NCT00744042|OG002|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
11176592|NCT02037165|OG003|Outcome|150 mg Pregabalin (Prega)|150 mg pregabalin (prega) hard capsule, single dose, mode of admin.: oral with 200 mL of water.
11176593|NCT02037165|OG003|Outcome|200 mg Celecoxib (Cele)|200 mg celecoxib (cele) hard capsule, single dose, Mode of Admin.: oral with 200 mL of water.
11176594|NCT02037165|OG003|Outcome|150 mg Pregabalin (Prega)|150 mg pregabalin (prega) hard capsule, single dose, Mode of Admin.: oral with 200 mL of water.
11176595|NCT02037165|EG000|Reported Event|Placebo|Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
11176596|NCT02037165|EG001|Reported Event|50 mg BI 1026706|treatment group: 50 mg BI 1026706
10936995|NCT00744042|OG000|Outcome|Study Week 1 Intravenous Dose (2mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2mg/mg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
10936996|NCT00744042|OG001|Outcome|Study Week 2 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
10936997|NCT00744042|EG000|Reported Event|Asfotase Alfa|All patients who received any asfotase alfa treatment, regardless of whether they were lost to follow-up or dropped out of the trial.
10936998|NCT00744055|BG000|Baseline|Prazosin|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
11176597|NCT02037165|EG002|Reported Event|200 mg BI 1026706|treatment group: 200 BI 1026706
11176598|NCT02037165|EG003|Reported Event|200 mg Celecoxib|treatment group: 200 mg celecoxib
11176599|NCT02037165|EG004|Reported Event|150 mg Pregabalin|treatment group: 150 mg pregabalin
11176600|NCT02037204|BG000|Baseline|Cartilage Repair Surgery|"Single-stage cartilage repair surgery using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.~Cartilage repair surgery: Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs"
11176601|NCT02037204|FG000|Participant Flow|Cartilage Repair Surgery|All 35 patients received a single-stage cartilage repair treatment using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
11176602|NCT02037204|OG000|Outcome|Cartilage Repair Surgery|Single-stage cartilage repair surgery in 35 patients, using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
10936999|NCT00744055|BG001|Baseline|Placebo|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
10937000|NCT00744055|BG002|Baseline|Total|Total of all reporting groups
10937001|NCT00744055|FG000|Participant Flow|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
10937002|NCT00744055|FG001|Participant Flow|Placebo|"Placebo in identical looking capsule blister packs~Placebo: Placebo"
10937003|NCT00744055|OG000|Outcome|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
10937004|NCT00744055|OG001|Outcome|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
11176603|NCT02037204|OG000|Outcome|Cartilage Repair Surgery|To evaluate the clinical status of the patients treated with the IMPACT therapy, the included patients were asked to complete the Knee injury and Osteoarthritis Outcome Scoring (KOOS), The visual analog scale (VAS) for pain and the EuroQoL 5-Dimension Health Questionnaire (EQ5D) at baseline (before IMPACT therapy) and at 3, 6, and 12 months follow-up.
11176604|NCT02037204|EG000|Reported Event|Cartilage Repair Surgery|All 35 patients received a single-stage cartilage repair treatment using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
11176605|NCT02037230|BG000|Baseline|AZD-1775 100 mg|"AZD-1775 (MK-1775) 100 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176606|NCT02037230|BG001|Baseline|AZD-1775 125 mg|"AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
10937005|NCT00744055|EG000|Reported Event|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
10937006|NCT00744055|EG001|Reported Event|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
11176607|NCT02037230|BG002|Baseline|AZD-1775 150 mg|"AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176608|NCT02037230|BG003|Baseline|AZD-1775 175 mg|"AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176609|NCT02037230|BG004|Baseline|Total|Total of all reporting groups
11176610|NCT02037230|FG000|Participant Flow|AZD-1775 100 mg|"AZD-1775 (MK-1775) 100 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176611|NCT02037230|FG001|Participant Flow|AZD-1775 125 mg|"AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11357640|NCT03751280|FG000|Participant Flow|PEAR-004|Eligible participants were to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life.
10937007|NCT00744211|BG000|Baseline|Vehicle|Saline, intravenous bolus
10937008|NCT00744211|BG001|Baseline|ET-ARA 1mg/kg|1mg/kg sitaxsentan sodium
10937009|NCT00744211|BG002|Baseline|ET-ARA 2mg/kg|2mg/kg sitaxsentan sodium
10937010|NCT00744211|BG003|Baseline|Total|Total of all reporting groups
10937011|NCT00744211|FG000|Participant Flow|Vehicle|Saline intravenous bolus
10937012|NCT00744211|FG001|Participant Flow|ET-ARA 1mg/kg|1mg/kg sitaxsentan sodium intravenous bolus
10937013|NCT00744211|FG002|Participant Flow|ET-ARA 2mg/kg|2mg/kg sitaxsentan sodium intravenous bolus
10937014|NCT00744211|OG000|Outcome|Vehicle|Vehicle group
10937015|NCT00744211|OG001|Outcome|1mg/kg ET-ARA|1 mg/kg ET-ARA
10937016|NCT00744211|OG002|Outcome|2mg/kg ET-ARA|2 mg/kg ET-ARA
10937017|NCT00744211|OG000|Outcome|Vehicle|Vehicle Group
10937018|NCT00744211|OG000|Outcome|1mg/kg ET-ARA|1 mg/kg ET-ARA
10937019|NCT00744211|OG001|Outcome|2mg/kg ET-ARA|2 mg/kg ET-ARA
10937020|NCT00744211|EG000|Reported Event|Vehicle|Vehicle Group
10937021|NCT00744211|EG001|Reported Event|ET-ARA 1mg/kg|ET - ARA 1 mg / kg
10937022|NCT00744211|EG002|Reported Event|ET-ARA 2mg/kg|ET - ARA 2 mg / kg
10937023|NCT00744237|BG000|Baseline|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
10937024|NCT00744237|BG001|Baseline|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
10937025|NCT00744237|BG002|Baseline|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
10937026|NCT00744237|BG003|Baseline|Total|Total of all reporting groups
10937027|NCT00744237|FG000|Participant Flow|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
10937028|NCT00744237|FG001|Participant Flow|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
10937029|NCT00744237|FG002|Participant Flow|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
10937030|NCT00744237|OG000|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
10937031|NCT00744237|OG001|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
10937032|NCT00744237|OG002|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
10937033|NCT00744237|EG000|Reported Event|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
10937034|NCT00744237|EG001|Reported Event|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
10937035|NCT00744237|EG002|Reported Event|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
10937036|NCT00744263|BG000|Baseline|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
10937037|NCT00744263|BG001|Baseline|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
10937038|NCT00744263|BG002|Baseline|Total|Total of all reporting groups
10937039|NCT00744263|FG000|Participant Flow|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
10937040|NCT00744263|FG001|Participant Flow|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
10937041|NCT00744263|OG000|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
10937042|NCT00744263|OG001|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
10937043|NCT00744263|EG000|Reported Event|13vPnC Safety Set|All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
10937044|NCT00744263|EG001|Reported Event|Placebo Safety Set|All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
10937045|NCT00744263|EG002|Reported Event|13vPnC Immunogenicity Subset|Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
10937046|NCT00744263|EG003|Reported Event|Placebo Immunogenicity Subset|Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
10937047|NCT00744328|BG000|Baseline|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
10937048|NCT00744328|BG001|Baseline|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
10937049|NCT00744328|BG002|Baseline|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
10937050|NCT00744328|BG003|Baseline|Total|Total of all reporting groups
10937051|NCT00744328|FG000|Participant Flow|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
10937052|NCT00744328|FG001|Participant Flow|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
10937053|NCT00744328|FG002|Participant Flow|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
10937054|NCT00744328|OG000|Outcome|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
10937055|NCT00744328|OG001|Outcome|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
10937056|NCT00744328|OG002|Outcome|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
10937057|NCT00744328|EG000|Reported Event|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
10937058|NCT00744328|EG001|Reported Event|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
10937059|NCT00744328|EG002|Reported Event|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
10937060|NCT00744380|BG000|Baseline|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
10937061|NCT00744380|BG001|Baseline|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
10937062|NCT00744380|BG002|Baseline|Total|Total of all reporting groups
10937063|NCT00744380|FG000|Participant Flow|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
10937064|NCT00744380|FG001|Participant Flow|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
10937065|NCT00744380|OG000|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
10937066|NCT00744380|OG001|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
10937067|NCT00744380|OG001|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
10937068|NCT00744380|EG000|Reported Event|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
11176612|NCT02037230|FG002|Participant Flow|AZD-1775 150 mg|"AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176613|NCT02037230|FG003|Participant Flow|AZD-1775 175 mg|"AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176614|NCT02037230|OG000|Outcome|AZD1775 (MK-1775), Gemcitabine, Radiation Therapy|"AZD1775 (MK-1775) will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy."
10937069|NCT00744380|EG001|Reported Event|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
10937070|NCT00744471|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937071|NCT00744471|BG001|Baseline|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937072|NCT00744471|BG002|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937073|NCT00744471|BG003|Baseline|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937074|NCT00744471|BG004|Baseline|Total|Total of all reporting groups
10937075|NCT00744471|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937076|NCT00744471|FG001|Participant Flow|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937077|NCT00744471|FG002|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937078|NCT00744471|FG003|Participant Flow|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937079|NCT00744471|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937080|NCT00744471|OG001|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937081|NCT00744471|OG002|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937082|NCT00744471|OG003|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937083|NCT00744471|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937084|NCT00744471|EG001|Reported Event|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937085|NCT00744471|EG002|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937086|NCT00744471|EG003|Reported Event|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
10937087|NCT00744497|BG000|Baseline|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
10937088|NCT00744497|BG001|Baseline|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
10937089|NCT00744497|BG002|Baseline|Total|Total of all reporting groups
10937090|NCT00744497|FG000|Participant Flow|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
10937091|NCT00744497|FG001|Participant Flow|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
10937092|NCT00744497|OG000|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
10937093|NCT00744497|OG001|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
10937094|NCT00744497|EG000|Reported Event|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
10937095|NCT00744497|EG001|Reported Event|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
10937096|NCT00744523|BG000|Baseline|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937097|NCT00744523|BG001|Baseline|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937098|NCT00744523|BG002|Baseline|Total|Total of all reporting groups
10937099|NCT00744523|FG000|Participant Flow|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937100|NCT00744523|FG001|Participant Flow|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937101|NCT00744523|OG000|Outcome|MO.MA Training Cases (Roll-In)|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937102|NCT00744523|OG001|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
10937103|NCT00744523|OG000|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937104|NCT00744523|OG001|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937105|NCT00744523|EG000|Reported Event|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937106|NCT00744523|EG001|Reported Event|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
10937107|NCT00744627|BG000|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10937108|NCT00744627|BG001|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
10937109|NCT00744627|BG002|Baseline|Total|Total of all reporting groups
10937110|NCT00744627|FG000|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10937111|NCT00744627|FG001|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
10937112|NCT00744627|OG000|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10937113|NCT00744627|OG001|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
10937114|NCT00744627|EG000|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
10937115|NCT00744627|EG001|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
10937116|NCT00744653|BG000|Baseline|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
10937117|NCT00744653|FG000|Participant Flow|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
10937118|NCT00744653|OG000|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
10937119|NCT00744653|OG000|Outcome|Electrochemotherapy|All patients treated with electrochemotherapy
10937120|NCT00744653|EG000|Reported Event|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
10937121|NCT00744692|BG000|Baseline|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
10937122|NCT00744692|FG000|Participant Flow|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
10937123|NCT00744692|OG000|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
10937124|NCT00744692|EG000|Reported Event|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
10937125|NCT00744757|BG000|Baseline|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
10937126|NCT00744757|FG000|Participant Flow|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
10937127|NCT00744757|OG000|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
10937128|NCT00744757|EG000|Reported Event|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
10937129|NCT00744796|BG000|Baseline|DSAEK Group|Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
10937130|NCT00744796|FG000|Participant Flow|DSAEK Group|Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
10937131|NCT00744796|OG000|Outcome|DSAEK Group|Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
10937132|NCT00744796|EG000|Reported Event|DSAEK Group|Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s).
10937133|NCT00744848|BG000|Baseline|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
10937134|NCT00744848|BG001|Baseline|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
10937135|NCT00744848|BG002|Baseline|Total|Total of all reporting groups
10937136|NCT00744848|FG000|Participant Flow|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
10937137|NCT00744848|FG001|Participant Flow|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
10937138|NCT00744848|OG000|Outcome|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
10937139|NCT00744848|OG001|Outcome|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
10937140|NCT00744848|EG000|Reported Event|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
10937141|NCT00744848|EG001|Reported Event|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
10937142|NCT00744861|BG000|Baseline|Exogen 4000+ Sham|Inactive LIPUS sham (single transducer)
10937143|NCT00744861|BG001|Baseline|Exogen 4000+|Active LIPUS device (single transducer)
10937144|NCT00744861|BG002|Baseline|Exospine Sham|Inactive LIPUS device (dual transducer)
10937145|NCT00744861|BG003|Baseline|Exospine|Active LIPUS device (dual transducer)
10937146|NCT00744861|BG004|Baseline|Total|Total of all reporting groups
10937147|NCT00744861|FG000|Participant Flow|Exogen 4000+ Sham|Inactive LIPUS sham (single transducer)
10937148|NCT00744861|FG001|Participant Flow|Exogen 4000+|Active LIPUS device (single transducer)
10937149|NCT00744861|FG002|Participant Flow|Exospine|Active LIPUS device (dual transducers)
10937150|NCT00744861|FG003|Participant Flow|Exospine Sham|Inactive Exospine device (dual transducers)
10937151|NCT00744861|OG000|Outcome|Exospine Sham|Exospine Inactive: dual transducers
10937152|NCT00744861|OG001|Outcome|Exospine Active|Exospine active: dual transducers
10937153|NCT00744861|EG000|Reported Event|Exogen 4000+ Sham|Stage 1 Feasibility: Exogen 4000+ sham, inactive single transducer
10937154|NCT00744861|EG001|Reported Event|Exogen 4000+|Stage 1 Feasibility: Exogen 4000+, active single transducer
10937155|NCT00744861|EG002|Reported Event|Exospine Sham|Stage 2 Pivotal: Exospine sham dual transducers
10937156|NCT00744861|EG003|Reported Event|Exospine|Stage 2 Pivotal: Exospine active dual transducers
10937157|NCT00744874|BG000|Baseline|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
10937158|NCT00744874|FG000|Participant Flow|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
10937159|NCT00744874|OG000|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
10937160|NCT00744874|OG000|Outcome|Ablated Patients Symptom Severity Score at Baseline|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at baseline.
10937161|NCT00744874|OG001|Outcome|Ablated Patients Symptom Severity Score at 3 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.
11357641|NCT03751280|FG001|Participant Flow|Sham|Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
10937162|NCT00744874|OG002|Outcome|Ablated Patients Symptom Severity Score at 6 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
10937163|NCT00744874|OG000|Outcome|Baseline Quality of Life Scores|Quality of life scores at baseline or before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
10937164|NCT00744874|OG001|Outcome|Quality of Life Scores at 3 Months|Quality of life scores at 3 months or 3 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
10937165|NCT00744874|OG002|Outcome|Quality of Life Scores at 6 Months|Quality of life scores at 6 months or 6 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
10937166|NCT00744874|OG000|Outcome|Cumulative Radio Frequency Time for PV Isolation|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
10937167|NCT00744874|EG000|Reported Event|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
10937168|NCT00744939|BG000|Baseline|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
10937169|NCT00744939|BG001|Baseline|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
10937170|NCT00744939|BG002|Baseline|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
10937171|NCT00744939|BG003|Baseline|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
10937172|NCT00744939|BG004|Baseline|Total|Total of all reporting groups
10937173|NCT00744939|FG000|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
10937174|NCT00744939|OG000|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
10937175|NCT00744939|OG001|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
10937176|NCT00744939|OG002|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
10937177|NCT00744939|OG003|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
10937178|NCT00744939|OG000|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
10937179|NCT00744939|OG001|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
10937180|NCT00744939|EG000|Reported Event|Mild Renal Impairment|Participants with eGFR >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
10937181|NCT00744939|EG001|Reported Event|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
10937182|NCT00744939|EG002|Reported Event|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
10937183|NCT00744939|EG003|Reported Event|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
10937184|NCT00744965|BG000|Baseline|Glyburide|"Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.~Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control."
10937185|NCT00744965|BG001|Baseline|Placebo|"Women with mild gestational diabetes will be started ADA diet and placebo.~Placebo: Sham dose adjustments of the placebo will be made."
10937186|NCT00744965|BG002|Baseline|Total|Total of all reporting groups
10937187|NCT00744965|FG000|Participant Flow|Placebo|"Women with mild gestational diabetes will be started ADA diet and placebo.~Placebo: Sham dose adjustments of the placebo will be made."
10937188|NCT00744965|FG001|Participant Flow|Glyburide|"Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.~Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control."
11176615|NCT02037230|OG000|Outcome|AZD-1775 100 mg|"AZD-1775 (MK-1775) 100 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
10937189|NCT00744965|OG000|Outcome|Placebo|"Women with mild gestational diabetes will be started ADA diet and placebo.~Placebo: Sham dose adjustments of the placebo will be made."
10937190|NCT00744965|OG001|Outcome|Glyburide|"Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.~Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control."
10937191|NCT00744965|EG000|Reported Event|Placebo|"Women with mild gestational diabetes will be started ADA diet and placebo.~Placebo: Sham dose adjustments of the placebo will be made."
10937192|NCT00744965|EG001|Reported Event|Glyburide|"Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.~Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control."
10937193|NCT00744978|BG000|Baseline|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
10937194|NCT00744978|BG001|Baseline|Placebo Then Varenicline|Placebo twice a day (BID) initiated with a 2-week titration regimen (Week 1: once a day [QD]; Week 2: BID), followed by varenicline 1 mg BID initiated with a 2-week titration regimen (Week 1: 0.5 mg QD; Week 2: 0.5 mg BID).
10937195|NCT00744978|BG002|Baseline|Total|Total of all reporting groups
10937196|NCT00744978|FG000|Participant Flow|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
10937197|NCT00744978|FG001|Participant Flow|Placebo Then Varenicline|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks; then varenicline 0.5 mg once daily for 1 week followed by 0.5 mg BID for 1 week followed by 1 mg BID for 4 weeks.
10937198|NCT00744978|OG000|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
10937199|NCT00744978|OG001|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
10937200|NCT00744978|EG000|Reported Event|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
10937201|NCT00744978|EG001|Reported Event|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
10937202|NCT00744991|BG000|Baseline|Enzastaurin|Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10937203|NCT00744991|FG000|Participant Flow|Enzastaurin|Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10937204|NCT00744991|OG000|Outcome|Mycosis Fungoides (MF)|Participants with histologically confirmed MF received enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10937205|NCT00744991|OG001|Outcome|Sezary Syndrome (SS)|Participants with histologically confirmed SS received enzastaurin 1125 mg loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10937206|NCT00744991|OG000|Outcome|Enzastaurin|Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-g) tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10937207|NCT00744991|OG000|Outcome|Enzastaurin|Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10937208|NCT00744991|EG000|Reported Event|Enzastaurin|Enzastaurin 1125 milligrams (mg) loading dose (total 9 tablets; three 125-mg tablets administered orally 3 times) on Day 1 followed by 500 mg enzastaurin (total 4 tablets; two 125-mg tablets administered orally twice daily) with a minimum of 8 hours between the 2 doses starting on Day 2 until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10937209|NCT00745095|BG000|Baseline|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)
10937210|NCT00745095|BG001|Baseline|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937211|NCT00745095|BG002|Baseline|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
10937212|NCT00745095|BG003|Baseline|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937213|NCT00745095|BG004|Baseline|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
10937214|NCT00745095|BG005|Baseline|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
10937215|NCT00745095|BG006|Baseline|Total|Total of all reporting groups
10937216|NCT00745095|FG000|Participant Flow|SCI MoviPrep® (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50 and SCI, GFR>=50) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (without neostigmine plus glycopyrrolate [NG])
10937217|NCT00745095|FG001|Participant Flow|SCI MoviPrep® (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50ml/min and SCI, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (with neostigmine plus glycopyrrolate [NG])~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937218|NCT00745095|FG002|Participant Flow|SCI PIEE (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate [NG])
10937219|NCT00745095|FG003|Participant Flow|SCI PIEE (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate [NG])~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937220|NCT00745095|FG004|Participant Flow|Control MoviPrep® Only|(Control, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] only (no neostigmine plus glycopyrrolate [NG])
10937221|NCT00745095|FG005|Participant Flow|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate [NG])
10937222|NCT00745095|OG000|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50 and GFR >=50) MoviPrep® (without NG)
11357642|NCT03751280|OG000|Outcome|PEAR-004|Eligible participants were to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life.
10937223|NCT00745095|OG001|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (withNG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937224|NCT00745095|OG002|Outcome|SCI PIEE (Without NG)|"(SCI, GFR>=50ml/min) PIEE (without NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937225|NCT00745095|OG003|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937226|NCT00745095|OG004|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
10937227|NCT00745095|OG005|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
10937228|NCT00745095|OG000|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® ( without NG)
10937229|NCT00745095|OG001|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937230|NCT00745095|OG002|Outcome|SCI PIEE ( Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
10937231|NCT00745095|EG000|Reported Event|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (without NG)
10937232|NCT00745095|EG001|Reported Event|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937233|NCT00745095|EG002|Reported Event|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
10937234|NCT00745095|EG003|Reported Event|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
10937235|NCT00745095|EG004|Reported Event|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
10937236|NCT00745095|EG005|Reported Event|SCI PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
10937237|NCT00745121|BG000|Baseline|Group-A, Osteoporosis/Osteopenia|Patients with osteoporosis/osteopenia.
10937238|NCT00745121|BG001|Baseline|Group-B, Control|Control (non-osteoporotic/-osteopenic patients).
10937239|NCT00745121|BG002|Baseline|Total|Total of all reporting groups
10937240|NCT00745121|FG000|Participant Flow|Group-A, Osteoporosis/Osteopenia|"Patients with osteoporosis/osteopenia.~Receiving OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm"
10937241|NCT00745121|FG001|Participant Flow|Group-B, Control|"Control (non-osteoporotic/-osteopenic patients).~Receiving OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm"
10937242|NCT00745121|OG000|Outcome|Group-A, Osteoporosis/Osteopenia|Patients with osteoporosis/osteopenia.
10937243|NCT00745121|OG001|Outcome|Group-B, Control|Control (non-osteoporotic/-osteopenic patients).
10937244|NCT00745121|EG000|Reported Event|Group-A, Osteoporosis/Osteopenia|Patients with osteoporosis/osteopenia.
10937245|NCT00745121|EG001|Reported Event|Group-B, Control|Control (non-osteoporotic/-osteopenic patients).
10937246|NCT00745251|BG000|Baseline|Placebo|
10937247|NCT00745251|BG001|Baseline|Top Dose|PHEN/TPM 15mg/92mg
10937248|NCT00745251|BG002|Baseline|Total|Total of all reporting groups
10937249|NCT00745251|FG000|Participant Flow|Placebo|
10937250|NCT00745251|FG001|Participant Flow|Top Dose|PHEN/TPM 15mg/92mg
10937251|NCT00745251|OG000|Outcome|Placebo|
10937252|NCT00745251|OG001|Outcome|Top Dose|PHEN/TPM 15mg/92mg
10937253|NCT00745251|EG000|Reported Event|Placebo|
10937254|NCT00745251|EG001|Reported Event|Top Dose|PHEN/TPM 15mg/92mg
10937255|NCT00745290|BG000|Baseline|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
10937256|NCT00745290|BG001|Baseline|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
10937257|NCT00745290|BG002|Baseline|Total|Total of all reporting groups
10937258|NCT00745290|FG000|Participant Flow|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
10937259|NCT00745290|FG001|Participant Flow|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
10937260|NCT00745290|OG000|Outcome|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
10937261|NCT00745290|OG001|Outcome|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
10937262|NCT00745290|EG000|Reported Event|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
10937263|NCT00745290|EG001|Reported Event|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
10937264|NCT00745368|BG000|Baseline|Raltegravir|Raltegravir 400 mg tablets twice daily
10937265|NCT00745368|FG000|Participant Flow|Raltegravir|Raltegravir 400 mg tablets twice daily
10937266|NCT00745368|OG000|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
10937267|NCT00745368|EG000|Reported Event|Raltegravir|Raltegravir 400 mg tablets twice daily
10937268|NCT00745420|BG000|Baseline|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
10937269|NCT00745420|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
10937270|NCT00745420|OG000|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
10937271|NCT00745420|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
10937272|NCT00745498|BG000|Baseline|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
10937273|NCT00745498|BG001|Baseline|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
10937274|NCT00745498|BG002|Baseline|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
10937275|NCT00745498|BG003|Baseline|Total|Total of all reporting groups
10937276|NCT00745498|FG000|Participant Flow|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
10937277|NCT00745498|FG001|Participant Flow|Introp IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
10937278|NCT00745498|FG002|Participant Flow|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
10937279|NCT00745498|OG000|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
10937280|NCT00745498|OG001|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
10937281|NCT00745498|OG002|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
10937282|NCT00745498|EG000|Reported Event|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
10937283|NCT00745498|EG001|Reported Event|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
10937284|NCT00745498|EG002|Reported Event|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
10937285|NCT00745615|BG000|Baseline|Double-Blind: Laquinimod 0.3 mg|Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
10937286|NCT00745615|BG001|Baseline|Double-Blind: Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
10937287|NCT00745615|BG002|Baseline|Double-Blind: Placebo/Laquinimod 0.3 mg|Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
10937288|NCT00745615|BG003|Baseline|Double-Blind: Placebo/Laquinimod 0.6 mg|Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
10937289|NCT00745615|BG004|Baseline|Total|Total of all reporting groups
10937290|NCT00745615|FG000|Participant Flow|Double-Blind: Laquinimod 0.3 mg|Participants who were receiving laquinimod 0.3 milligram (mg) tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
10937291|NCT00745615|FG001|Participant Flow|Double-Blind: Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
10937292|NCT00745615|FG002|Participant Flow|Double-Blind: Placebo/Laquinimod 0.3 mg|Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
10937293|NCT00745615|FG003|Participant Flow|Double-Blind: Placebo/Laquinimod 0.6 mg|Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
10937294|NCT00745615|FG004|Participant Flow|Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for relapsing-remitting multiple sclerosis [RRMS]) or early discontinuation (up to approximately 10.5 years).
10937295|NCT00745615|FG005|Participant Flow|Open Label: Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
10937296|NCT00745615|OG000|Outcome|Double-Blind: Laquinimod 0.3 mg|Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
10937297|NCT00745615|OG001|Outcome|Double-Blind: Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
10937298|NCT00745615|OG002|Outcome|Double-Blind: Placebo/Laquinimod 0.3 mg|Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
10937299|NCT00745615|OG003|Outcome|Double-Blind: Placebo/Laquinimod 0.6 mg|Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
10937300|NCT00745615|OG000|Outcome|Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
10937301|NCT00745615|OG001|Outcome|Open Label: Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
10937302|NCT00745615|EG000|Reported Event|Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg|Participants who were receiving either laquinimod 0.3 mg or placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
10937303|NCT00745615|EG001|Reported Event|Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) or placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
10963386|NCT00871741|EG000|Reported Event|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
10937304|NCT00745615|EG002|Reported Event|Open Label: Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
10937305|NCT00745615|EG003|Reported Event|Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg|Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
10937306|NCT00745823|BG000|Baseline|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
10937307|NCT00745823|BG001|Baseline|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
10937308|NCT00745823|BG002|Baseline|Total|Total of all reporting groups
10937309|NCT00745823|FG000|Participant Flow|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
10937310|NCT00745823|FG001|Participant Flow|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
10937311|NCT00745823|OG000|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
10937312|NCT00745823|OG001|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
10937313|NCT00745823|OG000|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg PO q.d. plus placebo to raltegravir PO b.i.d. plus one tablet of TRUVADA™ for 96 weeks
10937314|NCT00745823|OG001|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg b.i.d. administered with TRUVADA™
10937315|NCT00745823|EG000|Reported Event|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
10937316|NCT00745823|EG001|Reported Event|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
10937317|NCT00745849|BG000|Baseline|Entire Study Population|37 patients were included in Data Analysis. Study subjects were randomized to esomeprazole 40mg tablet twice daily or placebo for eight weeks each, with a two week washout crossover period in between treatment arms.
10937318|NCT00745849|FG000|Participant Flow|Placebo First, Then Esomeprazole|Placebo twice daily for 8 weeks, then two week washout, then Esomeprazole 40mg twice daily for 8 weeks
10937319|NCT00745849|FG001|Participant Flow|Esomeprazole First, Then Placebo|Esomeprazole 40mg twice daily for 8 weeks, then two week washout, then Placebo twice daily for 8 weeks
10937320|NCT00745849|OG000|Outcome|Esomeprazole Arm|esomeprazole: 40mg by mouth twice daily for 8 weeks
10937321|NCT00745849|OG001|Outcome|Placebo Arm|placebo twice daily for 8 weeks
10937322|NCT00745849|EG000|Reported Event|Events Occurring While Subject Was on Placebo|This arm includes all patients in the study, but focuses on the time period when they were on Placebo only.
10937323|NCT00745849|EG001|Reported Event|Events Occurring While Subject Was on Esomeprazole|This arm includes all patients in the study, but focuses on the time period when they were on Esomeprazole only.
11176616|NCT02037230|OG001|Outcome|AZD-1775 125 mg|"AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
10937324|NCT00745875|BG000|Baseline|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
10937325|NCT00745875|BG001|Baseline|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
10937326|NCT00745875|BG002|Baseline|Total|Total of all reporting groups
10937327|NCT00745875|FG000|Participant Flow|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
10937328|NCT00745875|FG001|Participant Flow|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
10937329|NCT00745875|OG000|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
10937330|NCT00745875|OG001|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
10937331|NCT00745875|EG000|Reported Event|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
10937332|NCT00745875|EG001|Reported Event|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
10937333|NCT00745901|BG000|Baseline|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
10937334|NCT00745901|BG001|Baseline|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
10937335|NCT00745901|BG002|Baseline|Total|Total of all reporting groups
10937336|NCT00745901|FG000|Participant Flow|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
10937337|NCT00745901|FG001|Participant Flow|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
10937338|NCT00745901|OG000|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
10937339|NCT00745901|OG001|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
10937340|NCT00745901|EG000|Reported Event|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
10937341|NCT00745901|EG001|Reported Event|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
10937342|NCT00745940|BG000|Baseline|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
10937343|NCT00745940|BG001|Baseline|MBCT Control Group|Control group waited.
10937344|NCT00745940|BG002|Baseline|Total|Total of all reporting groups
10937345|NCT00745940|FG000|Participant Flow|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
10937346|NCT00745940|FG001|Participant Flow|MBCT Control Group|Control group waited.
10937347|NCT00745940|OG000|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
10937348|NCT00745940|OG001|Outcome|MBCT Control Group|Control group waited.
10937349|NCT00745940|EG000|Reported Event|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
10937350|NCT00745940|EG001|Reported Event|MBCT Control Group|Control group waited.
10937351|NCT00746096|BG000|Baseline|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
10937352|NCT00746096|BG001|Baseline|Placebo|Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
10937353|NCT00746096|BG002|Baseline|Total|Total of all reporting groups
10937354|NCT00746096|FG000|Participant Flow|IKH-01|"Patient received IKH-01 orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.~The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
10937355|NCT00746096|FG001|Participant Flow|Placebo|"Patient received placebo orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.~The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
10937356|NCT00746096|OG000|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
10937357|NCT00746096|OG001|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
10937358|NCT00746096|EG000|Reported Event|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
10937359|NCT00746096|EG001|Reported Event|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
10937360|NCT00746122|BG000|Baseline|Open Repair|"Immediate Open Surgery~Open repair: Standard treatment of emergency open surgery"
10937361|NCT00746122|BG001|Baseline|Endovascular Strategy|"Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR~EVAR: Emergency endovascular aneurysm repair"
10937362|NCT00746122|BG002|Baseline|Total|Total of all reporting groups
10937363|NCT00746122|FG000|Participant Flow|Open Repair|"Immediate Open Surgery~Open repair: Standard treatment of emergency open surgery"
10937364|NCT00746122|FG001|Participant Flow|Endovascular Strategy|"Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR~EVAR: Emergency endovascular aneurysm repair"
10937365|NCT00746122|OG000|Outcome|Open Repair|"Immediate Open Surgery~Open repair: Standard treatment of emergency open surgery"
10937366|NCT00746122|OG001|Outcome|Endovascular Strategy|"Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR~EVAR: Emergency endovascular aneurysm repair"
10937367|NCT00746122|EG000|Reported Event|Open Repair|"Immediate Open Surgery~Open repair: Standard treatment of emergency open surgery"
10937368|NCT00746122|EG001|Reported Event|Endovascular Strategy|"Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR~EVAR: Emergency endovascular aneurysm repair"
10937369|NCT00746187|BG000|Baseline|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
10937370|NCT00746187|BG001|Baseline|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
10937371|NCT00746187|BG002|Baseline|Total|Total of all reporting groups
10937372|NCT00746187|FG000|Participant Flow|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
10937373|NCT00746187|FG001|Participant Flow|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
10937374|NCT00746187|OG000|Outcome|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
10937375|NCT00746187|OG001|Outcome|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
10937376|NCT00746187|EG000|Reported Event|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
11176617|NCT02037230|OG002|Outcome|AZD-1775 150 mg|"AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176618|NCT02037230|OG003|Outcome|AZD-1775 175 mg|"AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176619|NCT02037230|EG000|Reported Event|AZD-1775 100 mg|"AZD-1775 (MK-1775) 100 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
10937377|NCT00746187|EG001|Reported Event|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
11176620|NCT02037230|EG001|Reported Event|AZD-1775 125 mg|"AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176621|NCT02037230|EG002|Reported Event|AZD-1775 150 mg|"AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11176622|NCT02037230|EG003|Reported Event|AZD-1775 175 mg|"AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .~Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.~Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3"
11234214|NCT02432716|BG000|Baseline|All Study Participants|"Participants first receive either one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril) or placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril). After a washout period of 2 weeks, they then receive the opposite.~Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study~Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study"
10937378|NCT00746252|BG000|Baseline|Risperidone|"risperidone~risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing."
10937379|NCT00746252|BG001|Baseline|Aripiprazole|"aripiprazole~aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months."
10937380|NCT00746252|BG002|Baseline|Total|Total of all reporting groups
10937381|NCT00746252|FG000|Participant Flow|Risperidone|"risperidone~risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing."
10937382|NCT00746252|FG001|Participant Flow|Aripiprazole|"aripiprazole~aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months."
10937383|NCT00746252|OG000|Outcome|Risperidone|"risperidone~risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing."
10937384|NCT00746252|OG001|Outcome|Aripiprazole|"aripiprazole~aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months."
10937385|NCT00746252|EG000|Reported Event|Risperidone|"risperidone~risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing."
10937386|NCT00746252|EG001|Reported Event|Aripiprazole|"aripiprazole~aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months."
11176623|NCT02037256|BG000|Baseline|Arm A|"Pts. receive filgrastim SC on days 1-9 & begin apheresis on day 5. Pts. undergo apheresis for up to 2 days, & receive bortezomib intravenously (IV) over 3-5 seconds after target collection is obtained with filgrastim alone or on the 1st day of collection with the Bortezomib plus filgrastim mobilization, prior to receiving the administration of filgrastim. 2nd apheresis will continue until target stem cell dose is reached or for maximum 4 days. Pts. undergo autologous hematopoietic stem cell transplantation after receiving high dose chemotherapy & peripheral blood stem cell (PBSC) infusion following standard of care procedures.~bortezomib: Given IV~filgrastim: Given SC~autologous hematopoietic stem cell transplantation: Under"
11176624|NCT02037256|BG001|Baseline|Arm B|Pts. receive filgrastim SC on days 1-8 & receive bortezomib IV over 3-5 seconds on days 4 & day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8
11176625|NCT02037256|BG002|Baseline|Total|Total of all reporting groups
11176626|NCT02037256|FG000|Participant Flow|A. Standard of Care Mobilization|GROUP A: Standard of care mobiliation: Bortezomib (1.3 mg/m2) in the evening after completion of mobilization with G-CSF
11176627|NCT02037256|FG001|Participant Flow|GROUP B: Alternative Mobilization|GROUP B: Bortezomib (1.3 mg/m2) IV on days 4 and 7 (if needed)
11176628|NCT02037256|OG000|Outcome|Group A: Bortezomib 1.3 mg/m2|Group A: Bortezomib 1.3 mg/m2 in the evening after completion of 5 day mobilization with G-CSF
11176629|NCT02037256|OG001|Outcome|Group B Bortezomib 1/3 mg/m2|Group B Bortezomib 1/3 mg/m2 on day 4 of 5 day GCSF mobilizati
11176630|NCT02037256|OG000|Outcome|Arm A Standard of Care Mobilization|G-CSF 16 mcg/kg/day for 9 days; Bortezomib 1.3 mg/m2 IV on day 6. Blood draws and apheresis on days 5-9.
11176631|NCT02037256|OG001|Outcome|Arm B Alternative Mobilization|G-CSF16 mcg/kg/day for 8 days; Bortezomib on days 4 and 7. Blood collection on days 4 & 8, apheresis on days 5-8.
11176632|NCT02037256|EG000|Reported Event|A Treatment (Bortezomib and Filgrastim)|"GROUP A Pts. receive filgrastim SC on days 1-8 & receive bortezomib IV over 3-5 seconds on days 4 & day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8~bortezomib: Given IV~filgrastim: Given SC~autologous hematopoietic stem cell transplantation: Under"
11176633|NCT02037256|EG001|Reported Event|B Treatment (Bortezomib and Filgrastim)|Group B Pts receive filgrastim SC on days 1-8 and receive bortezomib IV over 3-5 seconds on days 4 and day 7 before administraioin of filgrastim. Pts undergo apheresis on days 5-8.
11176634|NCT02037295|BG000|Baseline|OF_UF Vancomycin|"Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin~Vancomycin: Vancomycin 125mg orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11176635|NCT02037295|BG001|Baseline|OF_UF Placebo|"Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo~Placebo oral tablet: Placebo pills orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11176636|NCT02037295|BG002|Baseline|UF_OF Vancomycin|"Healthy volunteers assigned underfeeding diet, overfeeding diet, and then vancomycin~Vancomycin: Vancomycin 125mg orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
10963387|NCT00871741|EG001|Reported Event|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
11176637|NCT02037295|BG003|Baseline|UF_OF Placebo|"Healthy volunteers assigned underfeeding diet, overfeeding diet, and then placebo~Placebo oral tablet: Placebo pills orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11176638|NCT02037295|BG004|Baseline|Total|Total of all reporting groups
11176639|NCT02037295|FG000|Participant Flow|OF_UF Vancomycin|"Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin~Vancomycin: Vancomycin 125mg orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11176640|NCT02037295|FG001|Participant Flow|OF_UF Placebo|"Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo~Placebo oral tablet: Placebo pills orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11176641|NCT02037295|FG002|Participant Flow|UF_OF Vancomycin|"Healthy volunteers assigned underfeeding diet, overfeeding diet, and then vancomycin~Vancomycin: Vancomycin 125mg orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11176642|NCT02037295|FG003|Participant Flow|UF_OF Placebo|"Healthy volunteers assigned underfeeding diet, overfeeding diet, and then placebo~Placebo oral tablet: Placebo pills orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11176643|NCT02037295|OG000|Outcome|Overfeeding|"Healthy volunteers assigned overfeeding diet~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements"
11176644|NCT02037295|OG001|Outcome|Underfeeding|"Healthy volunteers assigned underfeeding diet~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11234215|NCT02432716|FG000|Participant Flow|Insulin (Glulisine), Then Placebo|Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril).
10963388|NCT00871780|BG000|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
10937387|NCT00746330|BG000|Baseline|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
10937388|NCT00746330|BG001|Baseline|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
10937389|NCT00746330|BG002|Baseline|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
10937390|NCT00746330|BG003|Baseline|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
10937391|NCT00746330|BG004|Baseline|Total|Total of all reporting groups
10937392|NCT00746330|FG000|Participant Flow|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via Pressurized Metered Dose Inhaler (pMDI) + placebo to formoterol fumarate via Dry Powder Inhaler (DPI); Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
10937393|NCT00746330|FG001|Participant Flow|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
10937394|NCT00746330|FG002|Participant Flow|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
10937395|NCT00746330|FG003|Participant Flow|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
10937396|NCT00746330|OG000|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
10937397|NCT00746330|OG001|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
10937398|NCT00746330|OG002|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
10937399|NCT00746330|OG003|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
10937400|NCT00746330|OG002|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
10937401|NCT00746330|EG000|Reported Event|F12M|Formoterol Fumarate 12 μg Via pMDI/ Placebo Via DPI
10937402|NCT00746330|EG001|Reported Event|F12D|Placebo Via pMDI/ Formoterol Fumarate 12 μg Via DPI
10937403|NCT00746330|EG002|Reported Event|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
10937404|NCT00746330|EG003|Reported Event|Placebo|Placebo via pMDI/ Placebo via DPI
10937405|NCT00746356|BG000|Baseline|All Patients|All patients enrolled in the study
10937406|NCT00746356|FG000|Participant Flow|CRT-D Device Patients|All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.
10937407|NCT00746356|FG001|Participant Flow|ICD Device Patients|All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.
10937408|NCT00746356|OG000|Outcome|Participants Successfully Implanted With Devices|All participants successfully implanted with an ICD or CRT-D
10937409|NCT00746356|OG000|Outcome|Participants With Dual Chamber ICDs or CRTD Devices|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold
10937410|NCT00746356|OG000|Outcome|Participants With Single or Dual Chamber ICDs|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold in the right ventricle
10937411|NCT00746356|OG000|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle
10937412|NCT00746356|OG000|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle.
10937413|NCT00746356|EG000|Reported Event|All Patients|All patients enrolled in the study
10937414|NCT00746395|BG000|Baseline|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
10937415|NCT00746395|BG001|Baseline|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
10937416|NCT00746395|BG002|Baseline|Total|Total of all reporting groups
10937417|NCT00746395|FG000|Participant Flow|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
10937418|NCT00746395|FG001|Participant Flow|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
10937419|NCT00746395|OG000|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
10937420|NCT00746395|OG001|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
10937421|NCT00746395|EG000|Reported Event|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
10937422|NCT00746395|EG001|Reported Event|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
10937423|NCT00746421|BG000|Baseline|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
10937424|NCT00746421|BG001|Baseline|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
10937425|NCT00746421|BG002|Baseline|Total|Total of all reporting groups
10937426|NCT00746421|FG000|Participant Flow|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
10937427|NCT00746421|FG001|Participant Flow|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
10937428|NCT00746421|OG000|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
10937429|NCT00746421|OG001|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
10937430|NCT00746421|EG000|Reported Event|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
10937431|NCT00746421|EG001|Reported Event|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
10937432|NCT00746512|BG000|Baseline|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
10937433|NCT00746512|BG001|Baseline|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
10937434|NCT00746512|BG002|Baseline|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
10937435|NCT00746512|BG003|Baseline|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
10937436|NCT00746512|BG004|Baseline|Total|Total of all reporting groups
10937437|NCT00746512|FG000|Participant Flow|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
10937438|NCT00746512|FG001|Participant Flow|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
10937439|NCT00746512|FG002|Participant Flow|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
10937440|NCT00746512|FG003|Participant Flow|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
10937441|NCT00746512|OG000|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
10937442|NCT00746512|OG001|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
10937443|NCT00746512|OG002|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
10937444|NCT00746512|OG003|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
10937445|NCT00746512|EG000|Reported Event|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
10937446|NCT00746512|EG001|Reported Event|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
10937447|NCT00746512|EG002|Reported Event|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
11176645|NCT02037295|OG000|Outcome|Vancomycin|"Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin~Vancomycin: Vancomycin 125mg orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
11176646|NCT02037295|OG001|Outcome|Placebo|"Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo~Placebo oral tablet: Placebo pills orally four times per day for 12 days~Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements~Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements"
10937448|NCT00746512|EG003|Reported Event|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
11176647|NCT02037295|OG000|Outcome|Vancomycin|Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin Vancomycin: Vancomycin 125mg orally four times per day for 12 days Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
11176648|NCT02037295|OG001|Outcome|Placebo|Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo Placebo oral tablet: Placebo pills orally four times per day for 12 days Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
11176649|NCT02037295|EG000|Reported Event|Overfeeding|Healthy volunteers assigned overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
11176650|NCT02037295|EG001|Reported Event|Underfeeding|Healthy volunteers assigned underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
11176651|NCT02037295|EG002|Reported Event|Vancomycin|Healthy volunteers assigned Vancomycin: Vancomycin 125mg orally four times per day for 12 days
11176652|NCT02037295|EG003|Reported Event|Placebo|Healthy volunteers assigned Placebo oral tablet: Placebo pills orally four times per day for 12 days
11176653|NCT02037347|BG000|Baseline|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
11176654|NCT02037347|FG000|Participant Flow|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
11176655|NCT02037347|OG000|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
11176656|NCT02037347|EG000|Reported Event|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
10963389|NCT00871780|FG000|Participant Flow|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
11176657|NCT02037425|BG000|Baseline|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days). A total of 30 subjects were used in data analysis as 2 subjects did not complete any outcome measures once enrolled in the study.
11176658|NCT02037425|FG000|Participant Flow|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
11176659|NCT02037425|OG000|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
11176660|NCT02037425|OG001|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
11176661|NCT02037425|OG002|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
11176662|NCT02037425|EG000|Reported Event|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
11176663|NCT02037438|BG000|Baseline|CONV Arm|"Conventional (CONV) care for the diagnosis and treatment of sleep disorders~CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center"
11176664|NCT02037438|BG001|Baseline|PCCM ARM|"Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders~PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications."
10963390|NCT00871780|OG000|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
10963391|NCT00871780|OG000|Outcome|Natalizumab: Baseline EDSS 0 to 2.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS of 0 to 2.5
10963392|NCT00871780|OG001|Outcome|Natalizumab: Baseline EDSS 3.0 to 4.0|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS 3.0 to 4.0
11357643|NCT03751280|OG001|Outcome|Sham|Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
11357644|NCT03751280|EG000|Reported Event|PEAR-004|Eligible participants were to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life.
11357645|NCT03751280|EG001|Reported Event|Sham|Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
11357646|NCT03751280|EG002|Reported Event|Total|Total
11357647|NCT03751020|BG000|Baseline|Control|"Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days.~Control: Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies."
11357648|NCT03751020|BG001|Baseline|Expressive Writing (EW)|"Expressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.~Expressive Writing (EW) Intervention: The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered."
11357649|NCT03751020|BG002|Baseline|Self-Affirmation (SA)|"Self-Affirmation (SA) interventions prompt individuals to write advice to a (hypothetical) similarly stigmatized person regarding how best to cope with stigma-related stress. By affirming one's own stigmatized identity through the process of helping another similarly stigmatized person.~Self-Affirmation (SA) Intervention: The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences."
10937449|NCT00746551|BG000|Baseline|Iron Sucrose, Venofer, Intravenous Drug|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
10963393|NCT00871780|OG002|Outcome|Natalizumab: Baseline EDSS >= 4.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS >= 4.5
10963394|NCT00871780|EG000|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
11357650|NCT03751020|BG003|Baseline|Total|Total of all reporting groups
11357651|NCT03751020|FG000|Participant Flow|Control|"Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days.~Control: Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies."
11357652|NCT03751020|FG001|Participant Flow|Expressive Writing (EW)|"Expressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.~Expressive Writing (EW) Intervention: The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered."
11357653|NCT03751020|FG002|Participant Flow|Self-Affirmation (SA)|"Self-Affirmation (SA) interventions prompt individuals to write advice to a (hypothetical) similarly stigmatized person regarding how best to cope with stigma-related stress. By affirming one's own stigmatized identity through the process of helping another similarly stigmatized person.~Self-Affirmation (SA) Intervention: The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences."
11357654|NCT03751020|OG000|Outcome|Control|"Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days.~Control: Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies."
10937450|NCT00746551|BG001|Baseline|Ferrous Fumarate, Ferri-6, Oral Tablet|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
10937451|NCT00746551|BG002|Baseline|Total|Total of all reporting groups
10937452|NCT00746551|FG000|Participant Flow|Iron Sucrose, Venofer®, Intravenous Drug|Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
10937453|NCT00746551|FG001|Participant Flow|Ferrous Fumarate, Ferri-6®, Oral Tablet|In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
10937454|NCT00746551|OG000|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
10937455|NCT00746551|OG001|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
10937456|NCT00746551|EG000|Reported Event|Iron Sucrose, Venofer®, Intravenous Drug|"In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
10937457|NCT00746551|EG001|Reported Event|Ferrous Fumarate, Ferri-6®, Oral Tablet|Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
10937458|NCT00746564|BG000|Baseline|Open Label|All patients who were implanted with the SJM Confirm device.
10937459|NCT00746564|FG000|Participant Flow|SJM Confirm Device|All patients in this study received the St. Jude Medical (SJM Confirm device.
10937460|NCT00746564|OG000|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
10937461|NCT00746564|OG000|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
10937462|NCT00746564|OG000|Outcome|SJM Confirm Device|All patients implanted with the SJM Confirm device.
10937463|NCT00746564|EG000|Reported Event|SJM Confirm Device|All patients in this study received the SJM Confirm device.
10937464|NCT00746668|BG000|Baseline|All Study Participants|All subjects' reading performances were initially assessed before training began. Reading performance were assessed using sentences displayed on a computer monitor. Two lines of text were presented at the center of the monitor with each subject seated at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test.
10937465|NCT00746668|FG000|Participant Flow|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
10937466|NCT00746668|FG001|Participant Flow|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
10937467|NCT00746668|FG002|Participant Flow|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
10963395|NCT00871819|BG000|Baseline|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
10963396|NCT00871819|FG000|Participant Flow|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
10963397|NCT00871819|OG000|Outcome|All Subjects|All enrolled subjects
11234216|NCT02432716|FG001|Participant Flow|Placebo, Then Insulin (Glulisine)|Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril).
11234217|NCT02432716|OG000|Outcome|Insulin (Glulisine), Then Placebo|"Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril).~Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study~Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study"
11234218|NCT02432716|OG001|Outcome|Placebo, Then Insulin (Glulisine)|"Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril).~Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study~Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study"
11234219|NCT02432716|OG000|Outcome|Post- Placebo|"Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After receiving intranasal dose, participants completed the Fuld Object-Memory Evaluation.~Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study"
11234220|NCT02432716|OG001|Outcome|Post-Insulin (Glulisine)|"Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After receiving intranasal dose, participants completed the Fuld Object-Memory Evaluation.~Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study"
10937468|NCT00746668|FG003|Participant Flow|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
10963398|NCT00871819|EG000|Reported Event|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
11234221|NCT02432716|EG000|Reported Event|Post-Placebo|"Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After receiving intranasal dose, participants completed the Fuld Object-Memory Evaluation.~Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study"
11234222|NCT02432716|EG001|Reported Event|Post-Insulin (Glulisine)|"Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After receiving intranasal dose, participants completed the Fuld Object-Memory Evaluation.~Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study"
11234223|NCT02432729|BG000|Baseline|Enrolled|The Enrolled population included all subjects in the Full Safety Population, except 22 subjects enrolled at a site that was closed due to findings during a monitoring visit.
11234224|NCT02432729|FG000|Participant Flow|Abstinence3m Set|Enrolled subjects, who were abstinent from smoking from their actual quit date to at least Month 3, were included in the Abstinence3m set.
11234225|NCT02432729|OG000|Outcome|Abstinence3m|The Abstinence3m Set refers to enrolled subjects who were abstinent from smoking from their actual quit date to Month 3 (V8) or later.
11234226|NCT02432729|OG000|Outcome|Abstinence3m Set|Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
11234227|NCT02432729|EG000|Reported Event|Enrolled Population|The Enrolled Population included 1184 subjects enrolled from the screened population.
11234228|NCT02432742|BG000|Baseline|Restylane Perlane in One NLF and Restylane in the Other NLF|"Single injection and optional touch up injection with Restylane Perlane in one NLF and single injection and optional touch up injection with Restylane in the other NLF (split-face design).~Restylane Perlane: Intradermal injection, Restylane: Intradermal injection"
11234229|NCT02432742|FG000|Participant Flow|Restylane Perlane in One NLF and Restylane in the Other NLF|"Single injection and optional touch up injection with Restylane Perlane in one nasolabial fold (NLF) and single injection and optional touch up injection with Restylane in the other NLF (split-face design).~Restylane Perlane: Intradermal injection Restylane: Intradermal injection"
11234230|NCT02432742|OG000|Outcome|Restylane Perlane NLFs|"Single injection and optional touch up injection with Restylane Perlane in NLF~Restylane Perlane: Intradermal injection"
10963399|NCT00871845|BG000|Baseline|Lean|Lean (BMI<25)
11234231|NCT02432742|OG001|Outcome|Restylane NLFs|"Single injection and optional touch up injection with Restylane in NLF~Restylane: Intradermal injection"
11234232|NCT02432742|EG000|Reported Event|Restylane Perlane in One NLF and Restylane in the Other NLF|"Single injection and optional touch up injection with Restylane Perlane in one NLF and single injection and optional touch up injection with Restylane in the other NLF (split-face design).~Restylane Perlane: Intradermal injection, Restylane: Intradermal injection"
10963400|NCT00871845|BG001|Baseline|Overweight|Overweight (BMI>=25)
10963401|NCT00871845|BG002|Baseline|Total|Total of all reporting groups
10963402|NCT00871845|FG000|Participant Flow|Lean|Treatment naive HCV Genotype 1 infected patients with BMI<25
10963403|NCT00871845|FG001|Participant Flow|Overweight|Treatment naive HCV Genotype 1 infected patients with BMI >=25
11240711|NCT02481297|FG001|Participant Flow|Cohort 2: Untreated With High-rRisk mMolecular Features|"Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12."
10937469|NCT00746668|FG004|Participant Flow|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
10937470|NCT00746668|FG005|Participant Flow|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
10937471|NCT00746668|FG006|Participant Flow|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
10937472|NCT00746668|OG000|Outcome|Arm 1: Pre-Training|Baseline Assessment prior to training.
10937473|NCT00746668|OG001|Outcome|Arm 2: Assessment After Module 1|Assessment after six-weeks of training in Module 1 (PRL Awareness Training).
10937474|NCT00746668|OG002|Outcome|Arm 3: Assessment After Module 2|Assessment after six-weeks of training in Module 2 (Eye Movement Training).
10937475|NCT00746668|OG003|Outcome|Arm 4: Assessment After Module 3|Assessment after six-weeks of training in Module 3 (RSVP Reading).
10937476|NCT00746668|EG000|Reported Event|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
10937477|NCT00746668|EG001|Reported Event|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)~."
10937478|NCT00746668|EG002|Reported Event|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
10937479|NCT00746668|EG003|Reported Event|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
10937480|NCT00746668|EG004|Reported Event|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
10937481|NCT00746668|EG005|Reported Event|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
10937482|NCT00746668|EG006|Reported Event|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
10937483|NCT00746694|BG000|Baseline|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
11176665|NCT02037438|BG002|Baseline|Total|Total of all reporting groups
10963404|NCT00871845|OG000|Outcome|Lean|Lean (BMI<25)
10963405|NCT00871845|OG001|Outcome|Overweight|Overweight (BMI>=25)
10937484|NCT00746694|FG000|Participant Flow|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
10937485|NCT00746694|OG000|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
10937486|NCT00746694|EG000|Reported Event|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
10937487|NCT00746733|BG000|Baseline|Entire Study Population|
10937488|NCT00746733|FG000|Participant Flow|Vyvanse First|Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention.
10937489|NCT00746733|FG001|Participant Flow|Adderall XR First|Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention.
10937490|NCT00746733|OG000|Outcome|Vyvanse|
10937491|NCT00746733|OG001|Outcome|Adderall XR|
10937492|NCT00746733|OG002|Outcome|Vyvanse + Prilosec OTC|
10937493|NCT00746733|OG003|Outcome|Adderall XR + Prilosec OTC|
10937494|NCT00746733|OG000|Outcome|Vyvanse + Prilosec OTC|
10937495|NCT00746733|OG001|Outcome|Adderall XR + Prilosec OTC|
10937496|NCT00746733|OG000|Outcome|Adderall XR|
10937497|NCT00746733|EG000|Reported Event|Vyvanse|
10937498|NCT00746733|EG001|Reported Event|Adderall XR|
10937499|NCT00746733|EG002|Reported Event|Vyvanse + Prilosec OTC|
10937500|NCT00746733|EG003|Reported Event|Adderall XR + Prilosec OTC|
10937501|NCT00746785|BG000|Baseline|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
10937502|NCT00746785|BG001|Baseline|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
10937503|NCT00746785|BG002|Baseline|C - Placebo|placebo : placebo
10937504|NCT00746785|BG003|Baseline|Total|Total of all reporting groups
10937505|NCT00746785|FG000|Participant Flow|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
10937506|NCT00746785|FG001|Participant Flow|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
10937507|NCT00746785|FG002|Participant Flow|C - Placebo|placebo : placebo
10937508|NCT00746785|OG000|Outcome|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
10937509|NCT00746785|OG001|Outcome|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
10937510|NCT00746785|OG002|Outcome|C - Placebo|placebo : placebo
10937511|NCT00746785|EG000|Reported Event|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
10937512|NCT00746785|EG001|Reported Event|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
10937513|NCT00746785|EG002|Reported Event|C - Placebo|placebo : placebo
10937514|NCT00746798|BG000|Baseline|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
10937515|NCT00746798|BG001|Baseline|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
10937516|NCT00746798|BG002|Baseline|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
10937517|NCT00746798|BG003|Baseline|Placebo|Participants who received placebo (saline) given one time subcutaneously
10937518|NCT00746798|BG004|Baseline|Total|Total of all reporting groups
10937519|NCT00746798|FG000|Participant Flow|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
10937520|NCT00746798|FG001|Participant Flow|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
10937521|NCT00746798|FG002|Participant Flow|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
10937522|NCT00746798|FG003|Participant Flow|Placebo|Participants who received placebo (saline) given one time subcutaneously
10937523|NCT00746798|OG000|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
10937524|NCT00746798|OG001|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
10937525|NCT00746798|OG002|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
10937526|NCT00746798|OG003|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
10937527|NCT00746798|EG000|Reported Event|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
10937528|NCT00746798|EG001|Reported Event|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
10937529|NCT00746798|EG002|Reported Event|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
10937530|NCT00746798|EG003|Reported Event|Placebo|Participants who received placebo (saline) given one time subcutaneously
10937531|NCT00746863|BG000|Baseline|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
10963406|NCT00871845|OG000|Outcome|Lean|Lean (BMI < 25)
10937532|NCT00746863|BG001|Baseline|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
10937533|NCT00746863|BG002|Baseline|Total|Total of all reporting groups
10937534|NCT00746863|FG000|Participant Flow|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
10937535|NCT00746863|FG001|Participant Flow|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
10937536|NCT00746863|OG000|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
10937537|NCT00746863|OG001|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
10937538|NCT00746863|EG000|Reported Event|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
10937539|NCT00746863|EG001|Reported Event|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
10937540|NCT00746889|BG000|Baseline|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
10937541|NCT00746889|BG001|Baseline|Placebo|Intraarticular injection of 0.9% saline
10937542|NCT00746889|BG002|Baseline|Total|Total of all reporting groups
10937543|NCT00746889|FG000|Participant Flow|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
10937544|NCT00746889|FG001|Participant Flow|Placebo|Intraarticular injection of 0.9% saline
10937545|NCT00746889|OG000|Outcome|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
10937546|NCT00746889|OG001|Outcome|Placebo|Intraarticular injection of 0.9% saline
10937547|NCT00746889|OG000|Outcome|Inflammatory Patients Who Received Corticosteroid Injections|Patients with inflammatory characteristics on ultrsaound who were treated with corticosteroid knee injections
10937548|NCT00746889|OG001|Outcome|Noninflammatory Patients Who Received Corticosteroid Injection|Patients with noninflammatory characteristics on ultrasound who received saline placebo knee injections
10937549|NCT00746889|EG000|Reported Event|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
10937550|NCT00746889|EG001|Reported Event|Placebo|Intraarticular injection of 0.9% saline
10937551|NCT00746941|BG000|Baseline|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
10937552|NCT00746941|BG001|Baseline|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
10937553|NCT00746941|BG002|Baseline|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
10937554|NCT00746941|BG003|Baseline|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
10937555|NCT00746941|BG004|Baseline|Total|Total of all reporting groups
10937556|NCT00746941|FG000|Participant Flow|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
10937557|NCT00746941|FG001|Participant Flow|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
10937558|NCT00746941|FG002|Participant Flow|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
10963407|NCT00871845|OG001|Outcome|Overweight|Overweight (BMI >=25)
10937559|NCT00746941|FG003|Participant Flow|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
10937560|NCT00746941|OG000|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
10937561|NCT00746941|OG001|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
10937562|NCT00746941|OG001|Outcome|Local Standard of Care Plus Mefloquine 250 mg|"Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.~Also includes participants who were randomized to receive local standard of care (only) and added mefloquine at Week 4 or Week 8."
10937563|NCT00746941|EG000|Reported Event|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Weeks 4 or 8 to their standard of care treatment are counted in this treatment arm until the time of switching to mefloquine treatment."
10937564|NCT00746941|EG001|Reported Event|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Week 4 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
10937565|NCT00746941|EG002|Reported Event|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Week 8 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
10937566|NCT00746941|EG003|Reported Event|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
10937567|NCT00746954|BG000|Baseline|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
10937568|NCT00746954|FG000|Participant Flow|Arm 1 Control to ACET to BUS|Each patient will act as their own control, with comparisons over three nights, this is placebo
10937569|NCT00746954|FG001|Participant Flow|Arm 2 Acet to Placebo to Bus|Each patient will act as their own control, with comparisons over three nights, each night given actetazolamide (Acet 250mg), or placebo or buspirone (Bus 20mg),
10937570|NCT00746954|FG002|Participant Flow|Arm 3 BUS to ACET to PLA|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
10937571|NCT00746954|OG000|Outcome|BUSPIRONE|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
11176666|NCT02037438|FG000|Participant Flow|CONV Arm|"Conventional (CONV) care for the diagnosis and treatment of sleep disorders~CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center"
10937572|NCT00746954|OG001|Outcome|ACETAZOLAMIDE|Each patient will act as their own control, with comparisons over three nights
10937573|NCT00746954|OG002|Outcome|PLACEBO|Each patient will act as their own control, with comparisons over three nights
10937574|NCT00746954|EG000|Reported Event|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
10937575|NCT00747006|BG000|Baseline|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
10937576|NCT00747006|BG001|Baseline|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
10937577|NCT00747006|BG002|Baseline|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
10937578|NCT00747006|BG003|Baseline|Total|Total of all reporting groups
10937579|NCT00747006|FG000|Participant Flow|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
10937580|NCT00747006|FG001|Participant Flow|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
10937581|NCT00747006|FG002|Participant Flow|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
10937582|NCT00747006|OG000|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
10937583|NCT00747006|OG001|Outcome|0% Carbohydrate Load|Fasting state
10937584|NCT00747006|OG002|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
10937585|NCT00747006|OG003|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
10937586|NCT00747006|OG004|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
10937587|NCT00747006|EG000|Reported Event|TI Original Protocol Type 1 DM|Original protocol type 1 diabetes mellitus subjects
10937588|NCT00747006|EG001|Reported Event|TI Original Protocol Type 2 DM|Original protocol type 2 diabetes mellitus subjects
10937589|NCT00747006|EG002|Reported Event|TI Amendment 1 Type 2 DM|Technosphere Insulin treated subjects in protocol amendment 1
10937590|NCT00747006|EG003|Reported Event|Humalog Amendment 1 Type 2 DM|Humalog treated subjects in protocol amendment 1
10937591|NCT00747149|BG000|Baseline|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
10937592|NCT00747149|BG001|Baseline|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
10937593|NCT00747149|BG002|Baseline|Total|Total of all reporting groups
10937594|NCT00747149|FG000|Participant Flow|Rosuvastatin Titrated|10 mg rosuvastatin (RSV) as initial dose followed by 20 mg RSV as titrated dose or 20 mg rosuvastatin (RSV) as initial dose followed by 40 mg RSV as titrated dose
10937595|NCT00747149|FG001|Participant Flow|Rosuvastatin Non-titrated|10 mg RSV or 20 mg RSV
10937596|NCT00747149|OG000|Outcome|Rosuvastatin 10 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
10937597|NCT00747149|OG001|Outcome|Rosuvastatin 20 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
10937598|NCT00747149|OG002|Outcome|Rosuvastatin 20 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
10937599|NCT00747149|OG003|Outcome|Rosuvastatin 40 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
10937600|NCT00747149|EG000|Reported Event|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
10937601|NCT00747149|EG001|Reported Event|Rosuvastatin 10 mg (Continued, Non-titrated)|10 mg RSV as a continued, non-titrated dose
10937602|NCT00747149|EG002|Reported Event|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
10937603|NCT00747149|EG003|Reported Event|Rosuvastatin 20 mg (Continued, Non-titrated)|20 mg RSV as continued, non-titrated dose
10937604|NCT00747149|EG004|Reported Event|Rosuvastatin 20 mg (Titrated)|20 mg RSV as titrated dose
10937605|NCT00747149|EG005|Reported Event|Rosuvastatin 40 mg (Titrated)|20 mg RSV as titrated dose
10937606|NCT00747214|BG000|Baseline|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
10937607|NCT00747214|BG001|Baseline|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
10937608|NCT00747214|BG002|Baseline|Total|Total of all reporting groups
10937609|NCT00747214|FG000|Participant Flow|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone)~Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
10937610|NCT00747214|FG001|Participant Flow|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
10937611|NCT00747214|OG000|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
10937612|NCT00747214|OG001|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
10937613|NCT00747214|EG000|Reported Event|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) or placebo equivalent Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone) or placebo equivalent"
10937614|NCT00747214|EG001|Reported Event|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
10937615|NCT00747227|BG000|Baseline|ZV9003 Intraocular Lens|modified light transmission intraocular lens
10937616|NCT00747227|BG001|Baseline|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
10937617|NCT00747227|BG002|Baseline|Total|Total of all reporting groups
10937618|NCT00747227|FG000|Participant Flow|ZV9003 Intraocular Lens|modified light transmission intraocular lens
10937619|NCT00747227|FG001|Participant Flow|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
10937620|NCT00747227|OG000|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
10937621|NCT00747227|OG001|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
10937622|NCT00747227|EG000|Reported Event|ZV9003 Intraocular Lens|modified light transmission intraocular lens
10937623|NCT00747227|EG001|Reported Event|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
11240712|NCT02481297|OG000|Outcome|Cohort 1: Refractory/Relapsed After Prior Therapy|"Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12."
10937624|NCT00747344|BG000|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10937625|NCT00747344|BG001|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
10937626|NCT00747344|BG002|Baseline|Total|Total of all reporting groups
10937627|NCT00747344|FG000|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10937628|NCT00747344|FG001|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
10937629|NCT00747344|FG002|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
10937630|NCT00747344|FG003|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
10937631|NCT00747344|OG000|Outcome|Placebo|
10937632|NCT00747344|OG001|Outcome|Ustekinumab 45 mg|
10937633|NCT00747344|EG000|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
10937634|NCT00747344|EG001|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
10937635|NCT00747344|EG002|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
10937636|NCT00747344|EG003|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
10937637|NCT00747435|BG000|Baseline|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
10937638|NCT00747435|FG000|Participant Flow|Original Audiological Criteria|"Originally the study was designed to have two ARMs, but the second study ARM did not fully enroll. At the time of submission, the data for both ARMs was collapsed and data analysis was completed on all subjects as one group. The below inclusion criteria represents both ARMs as one group.~Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
10937639|NCT00747435|OG000|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
10937640|NCT00747435|EG000|Reported Event|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
10937641|NCT00747474|BG000|Baseline|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
10937642|NCT00747474|FG000|Participant Flow|Cohort 1 (1.5 mg/m^2)|Participants received 1.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937643|NCT00747474|FG001|Participant Flow|Cohort 2 (3 mg/m^2)|Participants received 3 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937644|NCT00747474|FG002|Participant Flow|Cohort 3 (6 mg/m^2)|Participants received 6 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937645|NCT00747474|FG003|Participant Flow|Cohort 4 (9 mg/m^2)|Participants received 9 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937646|NCT00747474|FG004|Participant Flow|Cohort 5 (13.5 mg/m^2)|Participants received 13.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937647|NCT00747474|FG005|Participant Flow|Cohort 6 (20 mg/m^2)|Participants received 20 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937648|NCT00747474|FG006|Participant Flow|Cohort 7 (30 mg/m^2)|Participants received 30 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937649|NCT00747474|FG007|Participant Flow|Cohort 8 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937650|NCT00747474|FG008|Participant Flow|Cohort 9 (35 mg/m^2)|Participants received 35 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937651|NCT00747474|FG009|Participant Flow|Cohort 10 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937652|NCT00747474|FG010|Participant Flow|Cohort 11 (50 mg/m^2)|Participants received 50 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937653|NCT00747474|FG011|Participant Flow|Cohort 12 (60 mg/m^2)|Participants received 60 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
10937654|NCT00747474|OG000|Outcome|All Participants|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle according to the dose assigned.
10937655|NCT00747474|OG000|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
10937656|NCT00747474|EG000|Reported Event|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
10937657|NCT00747552|BG000|Baseline|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
10937658|NCT00747552|FG000|Participant Flow|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
10937659|NCT00747552|OG000|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
10937660|NCT00747552|EG000|Reported Event|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
10937661|NCT00747565|BG000|Baseline|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
10937662|NCT00747565|BG001|Baseline|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
10937663|NCT00747565|BG002|Baseline|Total|Total of all reporting groups
10937664|NCT00747565|FG000|Participant Flow|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
10937665|NCT00747565|FG001|Participant Flow|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
10937666|NCT00747565|OG000|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
10937667|NCT00747565|OG001|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
10937668|NCT00747565|EG000|Reported Event|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. One additional multifocal subject was enrolled but received an incorrect lens; this subject is included for adverse event reporting for a total of 348 (347 +1) multifocal subjects.
10937669|NCT00747565|EG001|Reported Event|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
10937670|NCT00747617|BG000|Baseline|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
10937671|NCT00747617|BG001|Baseline|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
10937672|NCT00747617|BG002|Baseline|Total|Total of all reporting groups
10937673|NCT00747617|FG000|Participant Flow|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
10937674|NCT00747617|FG001|Participant Flow|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
10937675|NCT00747617|OG000|Outcome|PCOS|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
11192136|NCT02137447|FG000|Participant Flow|Negative Pressure Wound Therapy|"After the completion of the operation, incisional skin closure was performed using sutures or staples and the wound was then covered with the Negative Pressure Wound therapy Prevena Incision Management System (Kinetic Concepts Inc) as per the manufacturer's instructions of use. Continuous negative pressure was applied at 125 mm Hg.~For inpatients, wounds were assessed every 48 hours by inspection and palpation. The dressing was not routinely removed, but the surrounding skin was assessed for cellulitis. The NPWT dressing was removed between post-operative day 5 and 7."
10937676|NCT00747617|OG001|Outcome|Normal|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
10937677|NCT00747617|EG000|Reported Event|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
10937678|NCT00747617|EG001|Reported Event|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
10937679|NCT00747643|BG000|Baseline|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
10937680|NCT00747643|BG001|Baseline|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
10937681|NCT00747643|BG002|Baseline|Total|Total of all reporting groups
10937682|NCT00747643|FG000|Participant Flow|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
10937683|NCT00747643|FG001|Participant Flow|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
10937684|NCT00747643|OG000|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
10937685|NCT00747643|OG001|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
10937686|NCT00747643|EG000|Reported Event|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
10937687|NCT00747643|EG001|Reported Event|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
10937688|NCT00747747|BG000|Baseline|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
10937689|NCT00747747|BG001|Baseline|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
10937690|NCT00747747|BG002|Baseline|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
10937691|NCT00747747|BG003|Baseline|Total|Total of all reporting groups
10937692|NCT00747747|FG000|Participant Flow|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
10937693|NCT00747747|FG001|Participant Flow|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
10937694|NCT00747747|FG002|Participant Flow|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
10937695|NCT00747747|OG000|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
10937696|NCT00747747|OG001|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
10937697|NCT00747747|OG002|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
10937698|NCT00747747|EG000|Reported Event|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
10937699|NCT00747747|EG001|Reported Event|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
10937700|NCT00747747|EG002|Reported Event|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
10963408|NCT00871845|OG000|Outcome|Overweight Achieving >= 3% Weight Loss|Overweight subjects who achieved significant weight loss (>=3%)
10937701|NCT00747812|BG000|Baseline|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
10937702|NCT00747812|BG001|Baseline|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
10937703|NCT00747812|BG002|Baseline|Total|Total of all reporting groups
10937704|NCT00747812|FG000|Participant Flow|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
10937705|NCT00747812|FG001|Participant Flow|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
10937706|NCT00747812|OG000|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
10937707|NCT00747812|OG001|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
10937708|NCT00747812|EG000|Reported Event|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
10937709|NCT00747812|EG001|Reported Event|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
10937710|NCT00748033|BG000|Baseline|LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours|"All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.~After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds.~Then the next test catheter was used, LoFric POBE Hydro-Kit II, activation time 24 hours."
10937711|NCT00748033|BG001|Baseline|LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds|"All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.~After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 24 hours.~Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds."
10937712|NCT00748033|BG002|Baseline|Total|Total of all reporting groups
10937713|NCT00748033|FG000|Participant Flow|LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours|"Catheterizasion order:~Reference Catheter, then washout for 2 hours~LoFric POBE Hydro-Kit II activation time 5 seconds, then washout for 2 hours~LoFric POBE Hydro-Kit II activation time 24 hours"
10937714|NCT00748033|FG001|Participant Flow|LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds|"Catheterizasion order:~Reference Catheter, then washout for 2 hours~LoFric POBE Hydro-Kit II activation time 24 hours, then washout for 2 hours~LoFric POBE Hydro-Kit II activation time 5 seconds"
10937715|NCT00748033|OG000|Outcome|LoFric POBE Hydro-Kit II, 5 Seconds|"All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.~The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours."
10937716|NCT00748033|OG000|Outcome|LoFric POBE Hydro-Kit II, 24 Hours|All subjects were first catheterizised with the reference catheter then in a randomized order with the two test catheters.
10937717|NCT00748033|OG000|Outcome|LoFric POBE Hydro-Kit II, 5 Seconds Hours|"All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.~The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours."
10937718|NCT00748033|OG000|Outcome|LoFric POBE Hydro-Kit II, 24 Hours|"All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.~The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours."
10937719|NCT00748033|OG000|Outcome|LoFric POBE Hydro-Kit II, 5 Seconds|"All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.~After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.~After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds."
10937720|NCT00748033|OG001|Outcome|LoFric POBE Hydro-Kit II, 24 Hours|"All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.~After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.~After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds."
10937721|NCT00748033|OG000|Outcome|5s Followed by 24h|"Both groups were first catheterizied with the reference catheter. One group was then randomised to start with the catheter activated for 5 seconds followed by the catheter activated for 24 hours.~The other group was randomised to start with the the catheter activated for 24 hours followed by the catheter activated for 5 seconds."
10937722|NCT00748033|OG001|Outcome|24h Followed by 5s|"Both groups were first catheterizied with the reference catheter. One group was then randomised to start with the catheter activated for 5 seconds followed by the catheter activated for 24 hours.~The other group was randomised to start with the the catheter activated for 24 hours followed by the catheter activated for 5 seconds."
11192137|NCT02137447|OG000|Outcome|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
11192138|NCT02137447|EG000|Reported Event|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
10937723|NCT00748033|OG000|Outcome|MEAN Friction Value|Tension test system at withdrawal
10937724|NCT00748033|OG000|Outcome|Mean Friction Value|Mean Tension test system at withdrawal
10937725|NCT00748033|EG000|Reported Event|LoFric POBE Hydro-Kit II, 5 Seconds|"All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.~After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.~After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds."
10937726|NCT00748033|EG001|Reported Event|LoFric POBE Hydro-Kit II, 24 Hours|"All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.~After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.~After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds."
10937727|NCT00748072|BG000|Baseline|Saline Solution|patients treated with 1 ml of s.c. saline solution
10937728|NCT00748072|BG001|Baseline|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
10937729|NCT00748072|BG002|Baseline|Total|Total of all reporting groups
10937730|NCT00748072|FG000|Participant Flow|Saline Solution|patients treated with 1 ml of s.c. saline solution
10937731|NCT00748072|FG001|Participant Flow|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
10937732|NCT00748072|OG000|Outcome|Saline Solution|patients treated with 1 ml of s.c. saline solution
10937733|NCT00748072|OG001|Outcome|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
10937734|NCT00748072|EG000|Reported Event|Saline Solution|patients treated with 1 ml of s.c. saline solution
10937735|NCT00748072|EG001|Reported Event|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
10937736|NCT00748098|BG000|Baseline|All Participants in the Intent-to-Treat (ITT) Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline polysomnography (PSG) efficacy assessment
10937737|NCT00748098|FG000|Participant Flow|Placebo Followed by GEn 1200 mg/Day|Participants randomized to matching placebo administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period and the 7-day First Taper Period. No treatment was given during the 7-day Washout. Gabapentin enacarbil (GEn) 1200 mg/day administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day Second Taper Period. No treatment was given during Follow-up.
10937738|NCT00748098|FG001|Participant Flow|GEn 1200 mg/Day Followed by Placebo|Participants randomized to GEn 1200 mg/day administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day First Taper Period. No treatment was given during 7-day Washout. Matching placebo administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period and the 7-day Second Taper Period. No treatment was given during Follow-up.
10937739|NCT00748098|OG000|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
10937740|NCT00748098|OG001|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
10937741|NCT00748098|OG000|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
10937742|NCT00748098|EG000|Reported Event|Placebo|Participants who took at least one dose of placebo in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 132 took at least one dose of placebo.
10937743|NCT00748098|EG001|Reported Event|GEn 1200 mg|Participants who took at least one dose of GEn 1200 mg in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 127 took at least one dose of GEn 1200 mg.
10937744|NCT00748189|BG000|Baseline|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937745|NCT00748189|BG001|Baseline|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937746|NCT00748189|BG002|Baseline|Total|Total of all reporting groups
10937747|NCT00748189|FG000|Participant Flow|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937748|NCT00748189|FG001|Participant Flow|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937749|NCT00748189|OG000|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937750|NCT00748189|OG001|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937751|NCT00748189|OG000|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
11192139|NCT02137486|BG000|Baseline|Sequential Ballooning|treated with drug eluting stent or bare metal stent.
10937752|NCT00748189|OG001|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
10937753|NCT00748189|OG000|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937754|NCT00748189|OG001|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin's lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
10937755|NCT00748189|EG000|Reported Event|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937756|NCT00748189|EG001|Reported Event|Ofatumumab 1000 mg + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
10937757|NCT00748189|EG002|Reported Event|Total|All patients.
10937758|NCT00748215|BG000|Baseline|Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD)|Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.
10937759|NCT00748215|BG001|Baseline|Arm II: Placebo|Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
10937760|NCT00748215|BG002|Baseline|Total|Total of all reporting groups
10937761|NCT00748215|FG000|Participant Flow|Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD)|Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.
10937762|NCT00748215|FG001|Participant Flow|Arm II: Placebo|Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
10937763|NCT00748215|OG000|Outcome|Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD)|Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.
10937764|NCT00748215|OG001|Outcome|Arm II: Placebo|Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
10937765|NCT00748215|EG000|Reported Event|Arm I: Calcium Aluminosilicate Anti-Diarrheal (CASAD)|Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.
10937766|NCT00748215|EG001|Reported Event|Arm II: Placebo|Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
10937767|NCT00748241|BG000|Baseline|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
10937768|NCT00748241|FG000|Participant Flow|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
10937769|NCT00748241|OG000|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
10937770|NCT00748241|EG000|Reported Event|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
10937771|NCT00748410|BG000|Baseline|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
10937772|NCT00748410|BG001|Baseline|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
11176667|NCT02037438|FG001|Participant Flow|PCCM ARM|"Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders~PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications."
10937773|NCT00748410|BG002|Baseline|Total|Total of all reporting groups
10937774|NCT00748410|FG000|Participant Flow|SB656933 20 Milligram (mg)|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 milliliter(mL) of tepid water on every morning of Day 1 to 7 of the treatment period.
10937775|NCT00748410|FG001|Participant Flow|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
10937776|NCT00748410|OG000|Outcome|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
10937777|NCT00748410|OG001|Outcome|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
10963409|NCT00871845|OG001|Outcome|Overweight Not Achieving >=3% Weight Loss|Overweight subjects who did NOT achieve significant weight loss (>=3%)
10937778|NCT00748410|EG000|Reported Event|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
10937779|NCT00748410|EG001|Reported Event|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
10937780|NCT00748540|BG000|Baseline|Implanted|"Implanted with Vibrant Soundbridge~Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation"
10937781|NCT00748540|FG000|Participant Flow|Implanted|"Implanted with Vibrant Soundbridge~Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation"
10937782|NCT00748540|OG000|Outcome|Implanted|"Implanted with Vibrant Soundbridge~Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation"
10937783|NCT00748540|EG000|Reported Event|Implanted|"Implanted with Vibrant Soundbridge~Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation"
10937784|NCT00748553|BG000|Baseline|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
10937785|NCT00748553|BG001|Baseline|Phase I|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle~Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
10937786|NCT00748553|BG002|Baseline|Total|Total of all reporting groups
10937787|NCT00748553|FG000|Participant Flow|Phase 1|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle~Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
10937788|NCT00748553|FG001|Participant Flow|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
10937789|NCT00748553|OG000|Outcome|Phase 1|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle~Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
10937790|NCT00748553|OG000|Outcome|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
10937791|NCT00748553|EG000|Reported Event|Phase I and II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
10937792|NCT00748566|BG000|Baseline|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
10937793|NCT00748566|FG000|Participant Flow|Ziprasidone|Ziprasidone 40 milligram (mg) capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
10937794|NCT00748566|OG000|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
10937795|NCT00748566|EG000|Reported Event|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
10937796|NCT00748657|BG000|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
10937797|NCT00748657|FG000|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
10937798|NCT00748657|OG000|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
10937799|NCT00748657|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE (adverse event).
10937800|NCT00748657|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10937801|NCT00748657|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10937802|NCT00748657|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10937803|NCT00748657|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10937804|NCT00748657|OG005|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10937805|NCT00748657|EG000|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
10937806|NCT00748709|BG000|Baseline|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
10937807|NCT00748709|FG000|Participant Flow|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
10937808|NCT00748709|OG000|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
10937809|NCT00748709|EG000|Reported Event|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
10937810|NCT00748826|BG000|Baseline|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
10963410|NCT00871845|EG000|Reported Event|Lean|Lean (BMI < 25)
10963411|NCT00871845|EG001|Reported Event|Overweight|Overweight (BMI>=25)
10937811|NCT00748826|FG000|Participant Flow|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
10937812|NCT00748826|OG000|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
10937813|NCT00748826|EG000|Reported Event|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
10937814|NCT00748865|BG000|Baseline|Overall Study|
10937815|NCT00748865|FG000|Participant Flow|Systane Ultra Drops, Then Systane Drops|Patients received Systane Ultra Drops first, then received Systane Drops.
10937816|NCT00748865|FG001|Participant Flow|Systane Drops, Then Systane Ultra Drops|Patients first received Systane Drops, then received Systane Ultra Drops
10937817|NCT00748865|OG000|Outcome|Systane Ultra|Systane Ultra
10937818|NCT00748865|OG001|Outcome|Systane|Systane
10937819|NCT00748865|EG000|Reported Event|Systane Ultra|Systane Ultra
10937820|NCT00748865|EG001|Reported Event|Systane|Systane
10937821|NCT00748956|BG000|Baseline|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
10937822|NCT00748956|BG001|Baseline|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
10937823|NCT00748956|BG002|Baseline|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
10937824|NCT00748956|BG003|Baseline|Total|Total of all reporting groups
10937825|NCT00748956|FG000|Participant Flow|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
10937826|NCT00748956|FG001|Participant Flow|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
10937827|NCT00748956|FG002|Participant Flow|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
10937828|NCT00748956|OG000|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
10937829|NCT00748956|OG001|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
10937830|NCT00748956|OG002|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
10937831|NCT00748956|EG000|Reported Event|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
10937832|NCT00748956|EG001|Reported Event|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
10937833|NCT00748956|EG002|Reported Event|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
10937834|NCT00748969|BG000|Baseline|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
10937835|NCT00748969|BG001|Baseline|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
10937836|NCT00748969|BG002|Baseline|Total|Total of all reporting groups
10937837|NCT00748969|FG000|Participant Flow|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
10937838|NCT00748969|FG001|Participant Flow|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
10937839|NCT00748969|OG000|Outcome|Growth Hormone Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
10937840|NCT00748969|OG001|Outcome|No Growth Hormone Treatment|Observation only: no growth hormone treatment and no placebo.
10937841|NCT00748969|EG000|Reported Event|GH Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
10937842|NCT00748969|EG001|Reported Event|No GH Treatment|No placebo/no treatment
11192140|NCT02137486|BG001|Baseline|Final Kissing Ballooning|treated with drug eluting stent or bare metal stent.
11192141|NCT02137486|BG002|Baseline|Total|Total of all reporting groups
10937843|NCT00748982|BG000|Baseline|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
10937844|NCT00748982|BG001|Baseline|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
10937845|NCT00748982|BG002|Baseline|Total|Total of all reporting groups
10937846|NCT00748982|FG000|Participant Flow|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
10937847|NCT00748982|FG001|Participant Flow|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
10937848|NCT00748982|OG000|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
10937849|NCT00748982|OG001|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
10937850|NCT00748982|EG000|Reported Event|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
10937851|NCT00748982|EG001|Reported Event|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
10937852|NCT00749073|BG000|Baseline|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
10937853|NCT00749073|FG000|Participant Flow|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
10937854|NCT00749073|OG000|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
10937855|NCT00749073|OG000|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. The mean change and standard deviation between baseline (pretreatment) and Month 6 are reported, where a positive value represents the baseline value minus the 6 month value.
10937856|NCT00749073|EG000|Reported Event|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
10937857|NCT00749125|BG000|Baseline|1 Lexapro|"The depressed participants in this arm will be given Lexapro.~Lexapro: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day.~At both the initial and follow-up fMRI (functional magnetic resonance imaging) study visits, images of brain function and anatomy will be recorded."
10937858|NCT00749125|BG001|Baseline|2 Control|"The nondepressed participants in this arm will not be given any intervention for depression.~At both the initial and follow-up fMRI (functional magnetic resonance imaging) study visits, images of brain function and anatomy will be recorded."
10937859|NCT00749125|BG002|Baseline|Total|Total of all reporting groups
10937860|NCT00749125|FG000|Participant Flow|Control Participants|"The nondepressed participants in this arm will not be given any intervention for depression.~At both the initial (baseline) and follow-up (8 weeks following baseline visit) study visits, images of brain function and anatomy will be recorded."
10937861|NCT00749125|FG001|Participant Flow|Depressed Participants|"Following completion of their baseline study visit, the depressed participants will be given 8 weeks of antidepressant treatment as an intervention for depression.~At both the initial (baseline) and follow-up (post-intervention) study visits, images of brain function and anatomy will be recorded."
10937862|NCT00749125|OG000|Outcome|1 Lexapro|"The depressed participants in this arm will be given Lexapro.~Lexapro: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day"
10937863|NCT00749125|OG001|Outcome|2 Control|The nondepressed participants in this arm will not be given any intervention for depression.
10937864|NCT00749125|EG000|Reported Event|1 Lexapro|"The depressed participants in this arm will be given Lexapro.~Lexapro: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day.~At both the initial and follow-up fMRI (functional magnetic resonance imaging) study visits, images of brain function and anatomy will be recorded."
10937865|NCT00749125|EG001|Reported Event|2 Control|"The nondepressed participants in this arm will not be given any intervention for depression.~At both the initial and follow-up fMRI (functional magnetic resonance imaging) study visits, images of brain function and anatomy will be recorded."
10937866|NCT00749190|BG000|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
10937867|NCT00749190|BG001|Baseline|Empa 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
10937868|NCT00749190|BG002|Baseline|Empa 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10937869|NCT00749190|BG003|Baseline|Empa 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
11176668|NCT02037438|OG000|Outcome|CONV Arm|"Conventional (CONV) care for the diagnosis and treatment of sleep disorders~CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center"
11176669|NCT02037438|OG001|Outcome|PCCM ARM|"Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders~PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications."
10937870|NCT00749190|BG004|Baseline|Empa 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10937871|NCT00749190|BG005|Baseline|Empa 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
10937872|NCT00749190|BG006|Baseline|Sitag|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
10937873|NCT00749190|BG007|Baseline|Total|Total of all reporting groups
11176670|NCT02037438|EG000|Reported Event|CONV Arm|"Conventional (CONV) care for the diagnosis and treatment of sleep disorders~CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center"
11176671|NCT02037438|EG001|Reported Event|PCCM ARM|"Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders~PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications."
11176672|NCT02037477|BG000|Baseline|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
11176673|NCT02037477|BG001|Baseline|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
11176674|NCT02037477|BG002|Baseline|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
11176675|NCT02037477|BG003|Baseline|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
10937874|NCT00749190|FG000|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
10937875|NCT00749190|FG001|Participant Flow|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
10937876|NCT00749190|FG002|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
11176676|NCT02037477|BG004|Baseline|Total|Total of all reporting groups
11176677|NCT02037477|FG000|Participant Flow|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
11176678|NCT02037477|FG001|Participant Flow|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
11176679|NCT02037477|FG002|Participant Flow|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
11176680|NCT02037477|FG003|Participant Flow|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
11176681|NCT02037477|OG000|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
11176682|NCT02037477|OG001|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
11176683|NCT02037477|OG002|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
11176684|NCT02037477|OG003|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
10937877|NCT00749190|FG003|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10937878|NCT00749190|FG004|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
11176685|NCT02037477|EG000|Reported Event|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
11176686|NCT02037477|EG001|Reported Event|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
11176687|NCT02037477|EG002|Reported Event|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
11176688|NCT02037477|EG003|Reported Event|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
11176689|NCT02037555|BG000|Baseline|AT-III (Human)|"Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:~AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4"
11176690|NCT02037555|BG001|Baseline|Placebo|"Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.~Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia"
11176691|NCT02037555|BG002|Baseline|Total|Total of all reporting groups
10937879|NCT00749190|FG005|Participant Flow|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
10937880|NCT00749190|FG006|Participant Flow|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
10937881|NCT00749190|OG000|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
10937882|NCT00749190|OG001|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
10937883|NCT00749190|OG002|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10937884|NCT00749190|OG003|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10937885|NCT00749190|OG004|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10937886|NCT00749190|OG005|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
10937887|NCT00749190|OG006|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
10937888|NCT00749190|OG000|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
10937889|NCT00749190|OG001|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10937890|NCT00749190|OG002|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10937891|NCT00749190|OG003|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10937892|NCT00749190|OG004|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
10937893|NCT00749190|EG000|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
10937894|NCT00749190|EG001|Reported Event|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
10937895|NCT00749190|EG002|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10937896|NCT00749190|EG003|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10937897|NCT00749190|EG004|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
11176692|NCT02037555|FG000|Participant Flow|AT-III (Human)|"Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:~AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4"
10937898|NCT00749190|EG005|Reported Event|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
10937899|NCT00749190|EG006|Reported Event|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
10937900|NCT00749203|BG000|Baseline|Ketamine Then Midazolam|Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on Day 1, then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
10937901|NCT00749203|BG001|Baseline|Midazolam the Ketamine|Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on Day 1, then 2 weeks later Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
10937902|NCT00749203|BG002|Baseline|Total|Total of all reporting groups
11176693|NCT02037555|FG001|Participant Flow|Placebo|"Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.~Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia"
10937903|NCT00749203|FG000|Participant Flow|Ketamine Then Midazolam|"Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on day 1,~then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes"
10937904|NCT00749203|FG001|Participant Flow|Midazolam Then Ketamine|Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on day 1, then 2 weeks later, Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
10937905|NCT00749203|OG000|Outcome|Ketamine|"Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes~Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes"
10937906|NCT00749203|OG001|Outcome|Midazolam|"single dose 0.045 mg/kg IV infused over 40 minutes~Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes"
10937907|NCT00749203|EG000|Reported Event|Ketamine|Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes,
10937908|NCT00749203|EG001|Reported Event|Midazolam|Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
10937909|NCT00749268|BG000|Baseline|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
10937910|NCT00749268|BG001|Baseline|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
10937911|NCT00749268|BG002|Baseline|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
10937912|NCT00749268|BG003|Baseline|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
10937913|NCT00749268|BG004|Baseline|Total|Total of all reporting groups
10937914|NCT00749268|FG000|Participant Flow|Inguinal Arm|Patients with inguinal hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
10937915|NCT00749268|FG001|Participant Flow|Ventral Arm|Patients with ventral hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
10937916|NCT00749268|OG000|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
10937917|NCT00749268|OG001|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
10937918|NCT00749268|OG002|Outcome|Ventral Arm - Absorbatack|
10937919|NCT00749268|OG003|Outcome|Ventral Arm - ProTack|
10937920|NCT00749268|EG000|Reported Event|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
10937921|NCT00749268|EG001|Reported Event|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
10937922|NCT00749268|EG002|Reported Event|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
10937923|NCT00749268|EG003|Reported Event|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
11176694|NCT02037555|OG000|Outcome|AT-III (Human)|"Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:~AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4"
10937924|NCT00749398|BG000|Baseline|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
10937925|NCT00749398|FG000|Participant Flow|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
10937926|NCT00749398|OG000|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
10937927|NCT00749398|EG000|Reported Event|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
10937928|NCT00749411|BG000|Baseline|Placebo|Eligible participants received oral inhalation of matching Placebo via DPI once daily for 28 days.
10937929|NCT00749411|BG001|Baseline|GSK233705/GW642444|Eligible participants received oral inhalation of GSK233705 100 mcg / GW642444 25 mcg via DPI once daily for 28 days.
10937930|NCT00749411|BG002|Baseline|Total|Total of all reporting groups
10937931|NCT00749411|FG000|Participant Flow|Placebo|Eligible participants received oral inhalation of matching Placebo via dry powder inhaler (DPI) once daily for 28 days.
10937932|NCT00749411|FG001|Participant Flow|GSK233705/GW642444|Eligible participants received oral inhalation of GSK233705 100 microgram (mcg)/GW642444 25 mcg via DPI once daily for 28 days.
10937933|NCT00749411|OG000|Outcome|Placebo|Eligible participants received oral inhalation of matching Placebo via DPI once daily for 28 days.
10937934|NCT00749411|OG001|Outcome|GSK233705/GW642444|Eligible participants received oral inhalation of GSK233705 100 mcg / GW642444 25 mcg via DPI once daily for 28 days.
10937935|NCT00749411|EG000|Reported Event|Placebo|Eligible participants received oral inhalation of matching Placebo via DPI once daily for 28 days.
10937936|NCT00749411|EG001|Reported Event|GSK233705/GW642444|Eligible participants received oral inhalation of GSK233705 100 mcg / GW642444 25 mcg via DPI once daily for 28 days.
10963412|NCT00871858|BG000|Baseline|Arm A (ANA)|"Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.~anastrozole: Given orally"
10963413|NCT00871858|BG001|Baseline|Arm B (FULV)|"Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.~fulvestrant: Given intramuscularly"
10963414|NCT00871858|BG002|Baseline|Total|Total of all reporting groups
10963415|NCT00871858|FG000|Participant Flow|Arm A (ANA)|"Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.~anastrozole: Given orally"
10963416|NCT00871858|FG001|Participant Flow|Arm B (FULV)|"Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.~fulvestrant: Given intramuscularly"
10963417|NCT00871858|OG000|Outcome|Arm A (ANA)|"Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.~anastrozole: Given orally"
10963418|NCT00871858|OG001|Outcome|Arm B (FULV)|"Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.~fulvestrant: Given intramuscularly"
10963419|NCT00871858|EG000|Reported Event|Arm A (ANA)|"Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.~anastrozole: Given orally"
10963420|NCT00871858|EG001|Reported Event|Arm B (FULV)|"Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.~fulvestrant: Given intramuscularly"
10963421|NCT00871871|BG000|Baseline|All Part I Participants|Part I Overall: Hydrochlorothiazide (HCTZ) in Period 1 followed by Placebo in Period 2 or Placebo in Period 1, followed by HCTZ in Period 2
10963422|NCT00871871|BG001|Baseline|All Part II Participants|Part II Overall: Isosorbide mononitrate (ISMN)in Period 1, followed by placebo in Period 2 or placebo in Period 1, followed by ISMN in Period 2
10963423|NCT00871871|BG002|Baseline|Total|Total of all reporting groups
10963424|NCT00871871|FG000|Participant Flow|HCTZ First, Then HCTZ Placebo|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
10963425|NCT00871871|FG001|Participant Flow|HCTZ Placebo First, Then HCTZ|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
10963426|NCT00871871|FG002|Participant Flow|ISMN First, Then ISMN Placebo|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
10963427|NCT00871871|FG003|Participant Flow|ISMN Placebo First, Then ISMN|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
10963428|NCT00871871|OG000|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
10963429|NCT00871871|OG001|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
10963430|NCT00871871|OG000|Outcome|Isosorbide Mononitrate (ISMN)|Part II: Participants on ISMN in either Period 1 or Period 2
10963431|NCT00871871|OG001|Outcome|Isosorbide Mononitrate (ISMN) Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
10963432|NCT00871871|EG000|Reported Event|HCTZ|Part I: Participants on HCTZ in either Period 1 or Period 2
10963433|NCT00871871|EG001|Reported Event|HCTZ Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
10963434|NCT00871871|EG002|Reported Event|ISMN|Part II: Participants on ISMN in either Period 1 or Period 2
10963435|NCT00871871|EG003|Reported Event|ISMN Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
10963436|NCT00871923|BG000|Baseline|Phase II Tarceva for Brain Metastases in NSCLC|Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
10963437|NCT00871923|FG000|Participant Flow|Phase II Tarceva for Brain Metastases in NSCLC|Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
10937937|NCT00749463|BG000|Baseline|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
10937938|NCT00749463|BG001|Baseline|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
10937939|NCT00749463|BG002|Baseline|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
10937940|NCT00749463|BG003|Baseline|Total|Total of all reporting groups
10937941|NCT00749463|FG000|Participant Flow|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
10937942|NCT00749463|FG001|Participant Flow|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
10937943|NCT00749463|FG002|Participant Flow|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
10937944|NCT00749463|OG000|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
10937945|NCT00749463|OG001|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
10937946|NCT00749463|OG002|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
10937947|NCT00749463|EG000|Reported Event|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
10937948|NCT00749463|EG001|Reported Event|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
10937949|NCT00749463|EG002|Reported Event|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
10937950|NCT00749515|BG000|Baseline|Inadequate Responders|Patients having a rising ferritin trend over 3 consecutive months, at least one higher than 1500ng/mL (1500 µg/L) or rising liver iron documented by biopsy or change in T2 or Ferriscan magnetic resonance imaging (MRI) and on a dose of more than 30img/kg per day of deferasirox.
10937951|NCT00749515|BG001|Baseline|Adequate Responders (Control)|Patients having a ferritin trend below 1000 ng/mL (1000 µg/L) or documented declining liver iron burden by MRI or biopsy and on a dose of 30img/kg per day or less of deferasirox.
10937952|NCT00749515|BG002|Baseline|Total|Total of all reporting groups
10937953|NCT00749515|FG000|Participant Flow|Inadequate Responders|Patients having a rising ferritin trend over 3 consecutive months, at least one higher than 1500ng/mL (1500 µg/L) or rising liver iron documented by biopsy or change in T2 or Ferriscan magnetic resonance imaging (MRI) and on a dose of more than 30img/kg per day of deferasirox.
10937954|NCT00749515|FG001|Participant Flow|Adequate Responders (Control)|Patients having a ferritin trend below 1000 ng/mL (1000 µg/L) or documented declining liver iron burden by MRI or biopsy and on a dose of 30img/kg per day or less of deferasirox.
10937955|NCT00749515|OG000|Outcome|Inadequate Responders|Patients having a rising ferritin trend over 3 consecutive months, at least one higher than 1500ng/mL (1500 µg/L) or rising liver iron documented by biopsy or change in T2 or Ferriscan magnetic resonance imaging (MRI) and on a dose of more than 30img/kg per day of deferasirox.
10937956|NCT00749515|OG001|Outcome|Adequate Responders (Control)|Patients having a ferritin trend below 1000 ng/mL (1000 µg/L) or documented declining liver iron burden by MRI or biopsy and on a dose of 30img/kg per day or less of deferasirox.
10937957|NCT00749515|EG000|Reported Event|Inadequate Responders|Patients having a rising ferritin trend over 3 consecutive months, at least one higher than 1500ng/mL (1500 µg/L) or rising liver iron documented by biopsy or change in T2 or Ferriscan magnetic resonance imaging (MRI) and on a dose of more than 30img/kg per day of deferasirox.
10937958|NCT00749515|EG001|Reported Event|Adequate Responders (Control)|Patients having a ferritin trend below 1000 ng/mL (1000 µg/L) or documented declining liver iron burden by MRI or biopsy and on a dose of 30img/kg per day or less of deferasirox.
10937959|NCT00749580|BG000|Baseline|1: Boosted PI+RAL|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
10937960|NCT00749580|BG001|Baseline|2: Boosted PI+NRTIs|Group 2 Continue the same regimen without change
10937961|NCT00749580|BG002|Baseline|Total|Total of all reporting groups
10937962|NCT00749580|FG000|Participant Flow|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
10937963|NCT00749580|FG001|Participant Flow|Controlled|Group 2 Continue the same regimen without change
10937964|NCT00749580|OG000|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
10937965|NCT00749580|OG001|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
10937966|NCT00749580|EG000|Reported Event|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
10937967|NCT00749580|EG001|Reported Event|Controlled|Group 2 Continue the same regimen without change
10937968|NCT00749606|BG000|Baseline|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937969|NCT00749606|BG001|Baseline|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937970|NCT00749606|BG002|Baseline|Total|Total of all reporting groups
10937971|NCT00749606|FG000|Participant Flow|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10963438|NCT00871923|OG000|Outcome|Phase II Tarceva for Brain Metastases in NSCLC|Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
10937972|NCT00749606|FG001|Participant Flow|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937973|NCT00749606|OG000|Outcome|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937974|NCT00749606|OG001|Outcome|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937975|NCT00749606|OG000|Outcome|Individual Telephone Intervention|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937976|NCT00749606|OG001|Outcome|Group Telephone Intervention|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937977|NCT00749606|EG000|Reported Event|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937978|NCT00749606|EG001|Reported Event|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
10937979|NCT00749671|BG000|Baseline|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
10937980|NCT00749671|BG001|Baseline|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
10937981|NCT00749671|BG002|Baseline|Total|Total of all reporting groups
10937982|NCT00749671|FG000|Participant Flow|Bispectral Index Monitoring|Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.
10937983|NCT00749671|FG001|Participant Flow|Ramsey Scale Monitoring|Group assigned to sedation monitoring using the Ramsey Scale for ICD testing
10937984|NCT00749671|OG000|Outcome|ICD Testing|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
10937985|NCT00749671|OG001|Outcome|ICD testing2|"Ramsey Sedation Scale~Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
10937986|NCT00749671|OG000|Outcome|ICD Testing BIS|"Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.~Bispectral index monitoring: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
10937987|NCT00749671|OG001|Outcome|ICD Testing Ramsey|"Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT~Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
10937988|NCT00749671|EG000|Reported Event|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
10937989|NCT00749671|EG001|Reported Event|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
10937990|NCT00749684|BG000|Baseline|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
10937991|NCT00749684|FG000|Participant Flow|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
10937992|NCT00749684|OG000|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
10937993|NCT00749684|EG000|Reported Event|Interferon Alfa-2b|
10937994|NCT00749749|BG000|Baseline|Bupivacaine Collagen Sponge|"Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.~Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride"
10937995|NCT00749749|BG001|Baseline|ON-ON-Q PainBuster Post-op Pain Relief SystemQ System|"Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.~ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])"
10937996|NCT00749749|BG002|Baseline|Total|Total of all reporting groups
10937997|NCT00749749|FG000|Participant Flow|Bupivacaine Collagen Sponge|"Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.~Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride"
10937998|NCT00749749|FG001|Participant Flow|ON-ON-Q PainBuster Post-op Pain Relief SystemQ System|"Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.~ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])"
10937999|NCT00749749|OG000|Outcome|Bupivacaine Collagen Sponge|"Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.~Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride"
10938000|NCT00749749|OG001|Outcome|ON-ON-Q PainBuster Post-op Pain Relief SystemQ System|"Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.~ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])"
10938001|NCT00749749|EG000|Reported Event|Bupivacaine Collagen Sponge|"Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.~Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride"
10938002|NCT00749749|EG001|Reported Event|ON-ON-Q PainBuster Post-op Pain Relief SystemQ System|"Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.~ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])"
10938003|NCT00749775|BG000|Baseline|Selara|Participants taking Selara according to Japanese Package Insert.
10938004|NCT00749775|FG000|Participant Flow|Selara|Participants taking Selara according to Japanese Package Insert.
10938005|NCT00749775|OG000|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
10938006|NCT00749775|OG000|Outcome|At Baseline|Mean systolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
10938007|NCT00749775|OG001|Outcome|At 4 Weeks|Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
10938008|NCT00749775|OG002|Outcome|At 8 Weeks|Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
10938009|NCT00749775|OG003|Outcome|At 12 Weeks|Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
10938010|NCT00749775|OG004|Outcome|At Last Evaluation Date|Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
10938011|NCT00749775|OG000|Outcome|At Baseline|Mean diastolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
10938012|NCT00749775|OG001|Outcome|At 4 Weeks|Mean diastolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
10938013|NCT00749775|OG002|Outcome|At 8 Weeks|Mean diastolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
10938014|NCT00749775|OG003|Outcome|At 12 Weeks|Mean diastolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
10938015|NCT00749775|OG004|Outcome|At Last Evaluation Date|Mean diastolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
10938016|NCT00749775|EG000|Reported Event|Selara|Participants taking Selara according to Japanese Package Insert.
11176695|NCT02037555|OG001|Outcome|Placebo|"Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.~Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia"
10938017|NCT00749879|BG000|Baseline|All Subjects|All subjects enrolled
10938018|NCT00749879|FG000|Participant Flow|Proellex|in randomly assigned sequences, all study participants received 5 open-label treatments of Proellex: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State Proellex; 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
10938019|NCT00749879|OG000|Outcome|25 mg AMCC Fed|25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
10938020|NCT00749879|OG001|Outcome|25 mg AMCC Fasting|25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State
10938021|NCT00749879|OG002|Outcome|50 mg AMCC Fed|Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
10938022|NCT00749879|OG003|Outcome|50 mg AMCC Fasting|Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
10938023|NCT00749879|OG004|Outcome|50 mg SMCC Fasting|Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
10938024|NCT00749879|EG000|Reported Event|25 mg AMCC Fed|25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
10938025|NCT00749879|EG001|Reported Event|25 mg AMCC Fasting|25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State
10938026|NCT00749879|EG002|Reported Event|50 mg AMCC Fed|Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
10938027|NCT00749879|EG003|Reported Event|50 mg AMCC Fasting|Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
10938028|NCT00749879|EG004|Reported Event|50 mg SMCC Fasting|Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
10938029|NCT00749892|BG000|Baseline|Pre-surgical Erlotinib Treatment|Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
10938030|NCT00749892|FG000|Participant Flow|Pre-surgical Erlotinib Treatment|Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
10938031|NCT00749892|OG000|Outcome|Pre-surgical Erlotinib Treatment|Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
10938032|NCT00749892|EG000|Reported Event|Pre-surgical Erlotinib Treatment|Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
10938033|NCT00749931|BG000|Baseline|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
10938034|NCT00749931|BG001|Baseline|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
10938035|NCT00749931|BG002|Baseline|Total|Total of all reporting groups
10938036|NCT00749931|FG000|Participant Flow|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
10938037|NCT00749931|FG001|Participant Flow|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
10938038|NCT00749931|FG002|Participant Flow|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
10938039|NCT00749931|OG000|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
10938040|NCT00749931|OG001|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
10938041|NCT00749931|EG000|Reported Event|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
10938042|NCT00749931|EG001|Reported Event|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
10938043|NCT00749931|EG002|Reported Event|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
10938044|NCT00749944|BG000|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
10938045|NCT00749944|BG001|Baseline|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
10938046|NCT00749944|BG002|Baseline|Total|Total of all reporting groups
10938047|NCT00749944|FG000|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
10938048|NCT00749944|FG001|Participant Flow|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
10938049|NCT00749944|OG000|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
10938050|NCT00749944|OG001|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
10938051|NCT00749944|EG000|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
10938052|NCT00749944|EG001|Reported Event|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
10938053|NCT00749957|BG000|Baseline|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938054|NCT00749957|BG001|Baseline|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938055|NCT00749957|BG002|Baseline|Total|Total of all reporting groups
10938056|NCT00749957|FG000|Participant Flow|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938057|NCT00749957|FG001|Participant Flow|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938058|NCT00749957|OG000|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938059|NCT00749957|OG001|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938060|NCT00749957|OG000|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938061|NCT00749957|OG001|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938062|NCT00749957|EG000|Reported Event|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938063|NCT00749957|EG001|Reported Event|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
10938064|NCT00749996|BG000|Baseline|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
10938065|NCT00749996|BG001|Baseline|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
10938066|NCT00749996|BG002|Baseline|Total|Total of all reporting groups
10938067|NCT00749996|FG000|Participant Flow|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
10938068|NCT00749996|FG001|Participant Flow|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
10938069|NCT00749996|OG000|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
10938070|NCT00749996|OG001|Outcome|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
10938071|NCT00749996|EG000|Reported Event|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
10938072|NCT00749996|EG001|Reported Event|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
10938073|NCT00750061|BG000|Baseline|Placebo|"Placebo~Placebo: Matching placebo"
10938074|NCT00750061|BG001|Baseline|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
11240713|NCT02481297|OG001|Outcome|Cohort 2: Untreated With High-rRisk mMolecular Features|"Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12."
10938075|NCT00750061|BG002|Baseline|Total|Total of all reporting groups
10938076|NCT00750061|FG000|Participant Flow|Placebo|Placebo: Matching placebo
10938077|NCT00750061|FG001|Participant Flow|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
10938078|NCT00750061|OG000|Outcome|Placebo|"Placebo~Placebo: Matching placebo"
10938079|NCT00750061|OG001|Outcome|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
10938080|NCT00750061|EG000|Reported Event|Placebo|Placebo: Matching placebo
10938081|NCT00750061|EG001|Reported Event|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
10938082|NCT00750139|BG000|Baseline|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
10938083|NCT00750139|BG001|Baseline|Placebo 2-wks|Placebo applied daily for 2-weeks
10938084|NCT00750139|BG002|Baseline|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
10938085|NCT00750139|BG003|Baseline|Placebo 4-wks|Placebo cream applied daily for 4 weeks
10938086|NCT00750139|BG004|Baseline|Total|Total of all reporting groups
10938087|NCT00750139|FG000|Participant Flow|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
10938088|NCT00750139|FG001|Participant Flow|Placebo 2-wks|Placebo applied daily for 2-weeks
10938089|NCT00750139|FG002|Participant Flow|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
10938090|NCT00750139|FG003|Participant Flow|Placebo 4-wks|Placebo cream applied daily for 4 weeks
10938091|NCT00750139|OG000|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
10938092|NCT00750139|OG001|Outcome|Placebo 2-weeks|Placebo Control cream applied daily for 2-weeks
10938093|NCT00750139|OG002|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
10938094|NCT00750139|OG003|Outcome|Placebo 4-wks|Placebo control cream applied daily for 4 weeks
10938095|NCT00750139|OG001|Outcome|Placebo 2-wks|Placebo applied daily for 2-weeks
10938096|NCT00750139|OG003|Outcome|Placebo 4-wks|Placebo cream applied daily for 4 weeks
10938097|NCT00750139|EG000|Reported Event|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
10938098|NCT00750139|EG001|Reported Event|Placebo 2-wks|Placebo applied daily for 2-weeks
10938099|NCT00750139|EG002|Reported Event|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
10938100|NCT00750139|EG003|Reported Event|Placebo 4-wks|Placebo cream applied daily for 4 weeks
10938101|NCT00750152|BG000|Baseline|NAFT-500|Naftin 2% cream applied daily for 2 weeks
10938102|NCT00750152|BG001|Baseline|Placebo-2wks|Placebo cream applied daily for 2 weeks
10938103|NCT00750152|BG002|Baseline|Total|Total of all reporting groups
10938104|NCT00750152|FG000|Participant Flow|NAFT-500|Naftin 2% cream applied daily for 2 weeks
10938105|NCT00750152|FG001|Participant Flow|Placebo-2wks|Placebo cream applied daily for 2 weeks
10938106|NCT00750152|OG000|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
10938107|NCT00750152|OG001|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
10938108|NCT00750152|EG000|Reported Event|NAFT-500|Naftin 2% cream applied daily for 2 weeks
10938109|NCT00750152|EG001|Reported Event|Placebo-2wks|Placebo cream applied daily for 2 weeks
10938110|NCT00750165|BG000|Baseline|Titration Night|"Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device~SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine"
10938111|NCT00750165|FG000|Participant Flow|Titration Night|"Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device~SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine"
10938112|NCT00750165|OG000|Outcome|Titration Night|"Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device~SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine"
10938113|NCT00750165|EG000|Reported Event|Titration Night|"Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device~SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine"
10938114|NCT00750191|BG000|Baseline|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
10938115|NCT00750191|BG001|Baseline|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
10938116|NCT00750191|BG002|Baseline|Total|Total of all reporting groups
10938117|NCT00750191|FG000|Participant Flow|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
10938118|NCT00750191|FG001|Participant Flow|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
10938119|NCT00750191|OG000|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
10938120|NCT00750191|OG001|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
10963439|NCT00871923|EG000|Reported Event|Phase II Tarceva for Brain Metastases in NSCLC|Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
11176696|NCT02037555|EG000|Reported Event|AT-III (Human)|"Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:~AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4"
10938121|NCT00750191|EG000|Reported Event|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
10938122|NCT00750191|EG001|Reported Event|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
10938123|NCT00750282|BG000|Baseline|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938124|NCT00750282|BG001|Baseline|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938125|NCT00750282|BG002|Baseline|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938126|NCT00750282|BG003|Baseline|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938127|NCT00750282|BG004|Baseline|Total|Total of all reporting groups
10938128|NCT00750282|FG000|Participant Flow|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 megabequerel (MBq) single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions.
10938129|NCT00750282|FG001|Participant Flow|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938130|NCT00750282|FG002|Participant Flow|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938131|NCT00750282|FG003|Participant Flow|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938132|NCT00750282|OG000|Outcome|AD (Sensitivity) Group|All evaluated subjects with Alzheimer's disease
10938133|NCT00750282|OG001|Outcome|HV (Specificity) Group|All evaluated healthy volunteers
10938134|NCT00750282|OG000|Outcome|AD (Sensitivity) Group|All subjects evaluated as probable AD by consensus panel
10938135|NCT00750282|OG001|Outcome|HV (Specificity) Group|All subjects evaluated as healthy volunteer by consensus panel
10938136|NCT00750282|OG000|Outcome|AD (Sensitivity) Group (Part A)|All evaluated subjects with Alzheimer's disease from Part A
10938137|NCT00750282|OG001|Outcome|HV (Specificity) Group (Part A)|All evaluated healthy volunteers from Part A
10938138|NCT00750282|OG002|Outcome|AD (Sensitivity) Group (Part B)|All evaluated subjects with probable Alzheimer's disease from part B
10938139|NCT00750282|OG003|Outcome|HV (Specificity) Group (Part B)|All evaluated healthy volunteers from Part B
10938140|NCT00750282|OG000|Outcome|Imaging Window 45-60 Min Part A|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part A
10938141|NCT00750282|OG001|Outcome|Imaging Window 90-110 Min Part A|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part A
10938142|NCT00750282|OG002|Outcome|Imaging Window 110-130 Min Part A|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part A.
10938143|NCT00750282|OG003|Outcome|Imaging Window 45-60 Min Part B|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part B
10938144|NCT00750282|OG004|Outcome|Imaging Window 90-110 Min Part B|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B
10938145|NCT00750282|OG005|Outcome|Imaging Window 110-130 Min Part B|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
10938146|NCT00750282|OG000|Outcome|Alzheimer's (AD) Group (Part A)|All evaluated subjects with Alzheimer's disease
10938147|NCT00750282|OG001|Outcome|Healthy Volunteer (HV) Group (Part A)|All evaluated healthy volunteers
10938148|NCT00750282|OG002|Outcome|Alzheimer's (AD) Group (Part B)|"All subjects with consensus panel based diagnosis of probable AD"
10938149|NCT00750282|OG003|Outcome|Healthy Volunteer (HV) Group (Part B)|All subjects that were confirmed by consensus panel as healthy volunteers
10938150|NCT00750282|EG000|Reported Event|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938151|NCT00750282|EG001|Reported Event|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938152|NCT00750282|EG002|Reported Event|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938153|NCT00750282|EG003|Reported Event|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
10938154|NCT00750308|BG000|Baseline|Completed Subjects|Subjects who completed all four treatment arms.
10938155|NCT00750308|FG000|Participant Flow|Tadalafil, Ramipril, Combo, Placebo|
10938156|NCT00750308|FG001|Participant Flow|Ramipril, Tadalafil, Placebo, Combo|
10938157|NCT00750308|FG002|Participant Flow|Combo, Placebo, Tadalafil, Ramipril|
10938158|NCT00750308|FG003|Participant Flow|Placebo, Combo, Ramipril, Tadalafil|
10938159|NCT00750308|FG004|Participant Flow|Tadalafil, Placebo, Ramipril, Combo|
10938160|NCT00750308|FG005|Participant Flow|Ramipril, Combo, Tadalafil, Placebo|
10938161|NCT00750308|FG006|Participant Flow|Combo, Ramipril, Placebo, Tadalafil|
10938162|NCT00750308|FG007|Participant Flow|Placebo, Tadalafil, Combo, Ramipril|
10938163|NCT00750308|FG008|Participant Flow|Tadalafil, Combo, Placebo, Ramipril|
10938164|NCT00750308|FG009|Participant Flow|Ramipril, Placebo, Combo, Tadalafil|
10938165|NCT00750308|FG010|Participant Flow|Combo, Tadalafil, Ramipril, Placebo|
10938166|NCT00750308|FG011|Participant Flow|Placebo, Ramipril, Tadalafil, Combo|
10938167|NCT00750308|OG000|Outcome|Placeb Treatment|Measurements during placebo treatment for all 18 subjects who completed the protocol
10938168|NCT00750308|OG001|Outcome|Ramipril Treatment|Measurements during ramipril treatment for all 18 subjects who completed the protocol
10938169|NCT00750308|OG002|Outcome|Tadalafil Treatment|Measurements during tadalafil treatment for all 18 subjects who completed the protocol
10938170|NCT00750308|OG003|Outcome|Combination Treatment|Measurements during combination (ramipril and tadalafil) for all 18 subjects who completed the protocol
10938171|NCT00750308|OG000|Outcome|Placebo Treatment|Measured during placebo treatment in all 18 subjects who completed the study
10938172|NCT00750308|OG001|Outcome|Ramipril Treatment|Measured during ramipril treatment in all 18 subjects who completed the protocol
10938173|NCT00750308|OG002|Outcome|Tadalafil Treatment|Measured during tadalafil in all 18 subjects who completed the protocol
10938174|NCT00750308|OG003|Outcome|Combination Treatment|Measured during combination (ramipril and tadalafil) in all 18 subjects who completed treatment
10938175|NCT00750308|EG000|Reported Event|Placebo Treatment|Any adverse event that occurred during placebo treatment in anyone who received placebo treatment
10938176|NCT00750308|EG001|Reported Event|Ramipril Treatment|Any adverse event that occured durng ramipril treatment in anyone who received ramipril treatment
11240714|NCT02481297|EG000|Reported Event|Cohort 1: Refractory/Relapsed After Prior Therapy|"Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12."
10938177|NCT00750308|EG002|Reported Event|Tadalafil Tretament|Any adverse event that occurred during tadalafil treatment in anyone who received tadalafil treatment
10938178|NCT00750308|EG003|Reported Event|Combination Treatment|Any adverse event that occurred during combination (ramipril and tadalafil) treatment in anyone who received combination treatment
10938179|NCT00750360|BG000|Baseline|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
10938180|NCT00750360|BG001|Baseline|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
10938181|NCT00750360|BG002|Baseline|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
10938182|NCT00750360|BG003|Baseline|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
10938183|NCT00750360|BG004|Baseline|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
10938184|NCT00750360|BG005|Baseline|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
10938185|NCT00750360|BG006|Baseline|Total|Total of all reporting groups
10938186|NCT00750360|FG000|Participant Flow|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
10938187|NCT00750360|FG001|Participant Flow|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
10938188|NCT00750360|FG002|Participant Flow|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
10938189|NCT00750360|FG003|Participant Flow|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
10938190|NCT00750360|FG004|Participant Flow|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
10938191|NCT00750360|FG005|Participant Flow|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
10938192|NCT00750360|OG000|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
10938193|NCT00750360|OG001|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
10938194|NCT00750360|OG002|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
10938195|NCT00750360|OG003|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
10938196|NCT00750360|OG004|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
10938197|NCT00750360|OG005|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
10938198|NCT00750360|OG000|Outcome|Group B (Unprimed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
10938199|NCT00750360|OG001|Outcome|Group A (Primed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
10938200|NCT00750360|OG000|Outcome|Group B (Unprimed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
10938201|NCT00750360|OG001|Outcome|Group A (Primed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
10938202|NCT00750360|OG002|Outcome|Group A (Primed), ≥ 108 Months to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
10938203|NCT00750360|OG003|Outcome|Group A (Primed), ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
10938204|NCT00750360|EG000|Reported Event|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
10938205|NCT00750360|EG001|Reported Event|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
10938206|NCT00750360|EG002|Reported Event|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
10938207|NCT00750360|EG003|Reported Event|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
10938208|NCT00750360|EG004|Reported Event|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
10938209|NCT00750360|EG005|Reported Event|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
10938210|NCT00750373|BG000|Baseline|Conventional|Conventional Treatment based on current guidelines
10938211|NCT00750373|BG001|Baseline|Surgery|Early surgery within 48 hours of randomization
10938212|NCT00750373|BG002|Baseline|Total|Total of all reporting groups
10938213|NCT00750373|FG000|Participant Flow|Conventional|Conventional Treatment based on current guidelines
11176697|NCT02037555|EG001|Reported Event|Placebo|"Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.~Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia"
11176698|NCT02037568|BG000|Baseline|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
11176699|NCT02037568|BG001|Baseline|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
10938214|NCT00750373|FG001|Participant Flow|Surgery|Early surgery within 48 hours of randomization
10938215|NCT00750373|OG000|Outcome|Conventional|Conventional Treatment based on current guidelines
10938216|NCT00750373|OG001|Outcome|Surgery|Early surgery within 48 hours of randomization
11176700|NCT02037568|BG002|Baseline|Total|Total of all reporting groups
10938217|NCT00750373|EG000|Reported Event|Conventional|Conventional Treatment based on current guidelines
10938218|NCT00750373|EG001|Reported Event|Surgery|Early surgery within 48 hours of randomization
10938219|NCT00750438|BG000|Baseline|Inulin-control|Participants received inulin
10938220|NCT00750438|BG001|Baseline|Inulin-propionate Ester|Participants received inulin-propionate ester
10938221|NCT00750438|BG002|Baseline|Total|Total of all reporting groups
10938222|NCT00750438|FG000|Participant Flow|Inulin-control|Participants received inulin
10938223|NCT00750438|FG001|Participant Flow|Inulin-propionate Ester|Participants received inulin-propionate ester
10938224|NCT00750438|OG000|Outcome|Inulin-control|Participants received inulin
10938225|NCT00750438|OG001|Outcome|Inulin-propionate Ester|Participants received inulin-propionate ester
11176701|NCT02037568|FG000|Participant Flow|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
11192142|NCT02137486|FG000|Participant Flow|Sequential Ballooning|the stent is placed in the MV and dilated, and then a second balloon just proximal to the opening of the SB is dilated in order to widen the diameter of the MV at the SV opening to allow more blood to be diverted into the SB; then treated with drug eluting stent or bare metal stent.
10938226|NCT00750438|EG000|Reported Event|Inulin-control|Participants received inulin
10938227|NCT00750438|EG001|Reported Event|Inulin-propionate Ester|Participants received inulin-propionate ester
10938228|NCT00750737|BG000|Baseline|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
10938229|NCT00750737|BG001|Baseline|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
10938230|NCT00750737|BG002|Baseline|Total|Total of all reporting groups
10938231|NCT00750737|FG000|Participant Flow|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
10938232|NCT00750737|FG001|Participant Flow|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
10938233|NCT00750737|OG000|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
10938234|NCT00750737|OG001|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
10938235|NCT00750737|EG000|Reported Event|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
10938236|NCT00750737|EG001|Reported Event|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
10938237|NCT00750815|BG000|Baseline|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
10938238|NCT00750815|BG001|Baseline|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at the MPD at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
10938239|NCT00750815|BG002|Baseline|Total|Total of all reporting groups
10938240|NCT00750815|FG000|Participant Flow|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
10938241|NCT00750815|FG001|Participant Flow|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
10938242|NCT00750815|OG000|Outcome|A. Phase I Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
10938243|NCT00750815|OG000|Outcome|All Participants|"Arm A:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
10938244|NCT00750815|OG000|Outcome|High-Risk Myeloma|"Participants eligible for risk stratification with High-Risk Myeloma.~Arm A:~Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as Arm A."
10938245|NCT00750815|OG001|Outcome|Standard-Risk Myeloma|"Participants eligible for risk stratification with Standard-Risk Myeloma.~Arm A:~Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule Arm A."
10938246|NCT00750815|EG000|Reported Event|Dose Level 1|Participants at Dose Level 1
10938247|NCT00750815|EG001|Reported Event|Dose Level 2|Participants at Dose Level 2
10938248|NCT00750815|EG002|Reported Event|Dose Level 3|Participants at Dose Level 3
10938249|NCT00750815|EG003|Reported Event|Maximum Tolerated Dose|Participants at Dose Level 4
10938250|NCT00750867|BG000|Baseline|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
10938251|NCT00750867|FG000|Participant Flow|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
10938252|NCT00750867|OG000|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
10938253|NCT00750867|EG000|Reported Event|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
10938254|NCT00750880|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
11176702|NCT02037568|FG001|Participant Flow|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
11176703|NCT02037568|OG000|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
11176704|NCT02037568|OG001|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
11176705|NCT02037568|EG000|Reported Event|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
10938255|NCT00750880|FG000|Participant Flow|Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 20 weeks (total of 6 infusions).
10938256|NCT00750880|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
10938257|NCT00750880|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
10938258|NCT00750880|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
10938259|NCT00750893|BG000|Baseline|Rotarix Group|Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
10938260|NCT00750893|FG000|Participant Flow|Rotarix Group|Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
10938261|NCT00750893|OG000|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
10938262|NCT00750893|EG000|Reported Event|Rotarix Group|Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
10938263|NCT00750919|BG000|Baseline|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
10938264|NCT00750919|FG000|Participant Flow|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
10938265|NCT00750919|OG000|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
10938266|NCT00750919|EG000|Reported Event|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
10938267|NCT00751023|BG000|Baseline|Modafinil|"Modafinil 400 mg daily~Modafinil: 400 mg daily for four weeks"
10938268|NCT00751023|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo 2 tablets daily for 4 weeks"
10938269|NCT00751023|BG002|Baseline|Total|Total of all reporting groups
10938270|NCT00751023|FG000|Participant Flow|Modafinil|"Modafinil 400 mg daily~Modafinil: 400 mg daily for four weeks"
10938271|NCT00751023|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo 2 tablets daily for 4 weeks"
10938272|NCT00751023|OG000|Outcome|Modafinil|"Modafinil 400 mg daily~Modafinil: 400 mg daily for four weeks"
10938273|NCT00751023|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo 2 tablets daily for 4 weeks"
10938274|NCT00751023|EG000|Reported Event|Modafinil|Modafinil: 400 mg daily for four weeks
10938275|NCT00751023|EG001|Reported Event|Placebo|Placebo: 2 tablets daily for four weeks
10938276|NCT00751036|BG000|Baseline|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
10938277|NCT00751036|BG001|Baseline|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
10938278|NCT00751036|BG002|Baseline|Total|Total of all reporting groups
10938279|NCT00751036|FG000|Participant Flow|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
10938280|NCT00751036|FG001|Participant Flow|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
10938281|NCT00751036|OG000|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
10938282|NCT00751036|OG001|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
10938283|NCT00751036|EG000|Reported Event|Nilotinib 800 mg|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
10938284|NCT00751036|EG001|Reported Event|Imatinib 800 mg|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
10938285|NCT00751101|BG000|Baseline|Arm A: Prior to Initiation of Capecitabine|Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938286|NCT00751101|BG001|Baseline|Arm B: After Hand-foot Syndrome Symptoms Appear|Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938287|NCT00751101|BG002|Baseline|Total|Total of all reporting groups
10938288|NCT00751101|FG000|Participant Flow|Arm A: Prior to Initiation of Capecitabine|Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938289|NCT00751101|FG001|Participant Flow|Arm B: After Hand-foot Syndrome (HFS) Symptoms Appear|Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938290|NCT00751101|OG000|Outcome|Arm A: Prior to Initiation of Capecitabine|Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938291|NCT00751101|OG001|Outcome|Arm B: After Hand-foot Syndrome Symptoms Appear|Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938292|NCT00751101|OG000|Outcome|Arm A|Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938293|NCT00751101|OG001|Outcome|Arm B|Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938294|NCT00751101|OG000|Outcome|Arm A: Prior to Initiation of Capecitabine|"Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.~Nicotine patch: Nicotine patch applied prior to and concurrently with capecitabine chemotherapy or beginning during the first course of capecitabine after the onset of hand-foot syndrome symptoms"
10938295|NCT00751101|OG001|Outcome|Arm B: After Hand-foot Syndrome Symptoms Appear|"Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.~Nicotine patch: Nicotine patch applied prior to and concurrently with capecitabine chemotherapy or beginning during the first course of capecitabine after the onset of hand-foot syndrome symptoms"
10938296|NCT00751101|EG000|Reported Event|Arm A: Prior to Initiation of Capecitabine|Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938297|NCT00751101|EG001|Reported Event|Arm B: After Hand-foot Syndrome Symptoms Appear|Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
10938298|NCT00751114|BG000|Baseline|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
10938299|NCT00751114|BG001|Baseline|Sitagliptin|Dose of 100 mg once a day administered with or without food
10938300|NCT00751114|BG002|Baseline|Total|Total of all reporting groups
10938301|NCT00751114|FG000|Participant Flow|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the Fasting Plasma Glucose (FPG) target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
10938302|NCT00751114|FG001|Participant Flow|Sitagliptin|Dose of 100 mg once a day administered with or without food
10938303|NCT00751114|OG000|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
10938304|NCT00751114|OG001|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
10938305|NCT00751114|EG000|Reported Event|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
10938306|NCT00751114|EG001|Reported Event|Sitagliptin|Dose of 100 mg once a day administered with or without food
10938307|NCT00751140|BG000|Baseline|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
10938308|NCT00751140|FG000|Participant Flow|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
10938309|NCT00751140|OG000|Outcome|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
10938310|NCT00751140|OG000|Outcome|Total Lymph Node Count|Total Lymph Node Count for All Participants
10938311|NCT00751140|OG001|Outcome|Open RNU Lymph Node Count|Lymph Node Count for Open RNU Procedure Group
10938312|NCT00751140|OG002|Outcome|Laparoscopic RNU Lymph Node Count|Lymph Node Count for Laparoscopic RNU Procedure Group
10938313|NCT00751140|OG003|Outcome|Robot-assisted RNU Lymph Node Count|Lymph Node Count for Robot-assisted RNU Procedure Group
10938314|NCT00751140|EG000|Reported Event|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
10938315|NCT00751179|BG000|Baseline|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
10938316|NCT00751179|BG001|Baseline|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
10938317|NCT00751179|BG002|Baseline|Total|Total of all reporting groups
10938318|NCT00751179|FG000|Participant Flow|Rocuronium - Sugammadex|An intubation dose of rocuronium (roc) was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex (sug) was administered for reversal of neuromuscular blockade.
10938319|NCT00751179|FG001|Participant Flow|Succinylcholine|An intubation dose of succinylcholine (suc) was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
10938320|NCT00751179|OG000|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
10938321|NCT00751179|OG001|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
10938322|NCT00751179|OG000|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
10938323|NCT00751179|EG000|Reported Event|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
10938324|NCT00751179|EG001|Reported Event|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
10938325|NCT00751296|BG000|Baseline|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles)."
10938326|NCT00751296|FG000|Participant Flow|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
10938327|NCT00751296|OG000|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
10938328|NCT00751296|EG000|Reported Event|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
10938329|NCT00751348|BG000|Baseline|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
10938330|NCT00751348|BG001|Baseline|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
10938331|NCT00751348|BG002|Baseline|Total|Total of all reporting groups
10938332|NCT00751348|FG000|Participant Flow|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
10938333|NCT00751348|FG001|Participant Flow|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
10938334|NCT00751348|OG000|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
10938335|NCT00751348|OG001|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
10938336|NCT00751348|EG000|Reported Event|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
10938337|NCT00751348|EG001|Reported Event|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
10938338|NCT00751400|BG000|Baseline|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
10938339|NCT00751400|FG000|Participant Flow|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
10938340|NCT00751400|OG000|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
10938341|NCT00751400|EG000|Reported Event|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
10938342|NCT00751530|BG000|Baseline|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
10938343|NCT00751530|BG001|Baseline|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
10938344|NCT00751530|BG002|Baseline|Total|Total of all reporting groups
10938345|NCT00751530|FG000|Participant Flow|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
10938346|NCT00751530|FG001|Participant Flow|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
10938347|NCT00751530|OG000|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
10938348|NCT00751530|OG001|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
10938349|NCT00751530|EG000|Reported Event|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
10938350|NCT00751530|EG001|Reported Event|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
10938351|NCT00751621|BG000|Baseline|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
10938352|NCT00751621|FG000|Participant Flow|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
10938353|NCT00751621|OG000|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
10938354|NCT00751621|OG000|Outcome|IgPro20 - At Baseline|SF-36 score at baseline.
10938355|NCT00751621|OG001|Outcome|IgPro20 - At End of Study|SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
10938356|NCT00751621|EG000|Reported Event|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
10938357|NCT00751634|BG000|Baseline|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
10938358|NCT00751634|FG000|Participant Flow|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
10938359|NCT00751634|OG000|Outcome|Treatment Group at 0, 1, 2, 6 Hours|Application of the Gaymar Rapr-Round device per approved use
10938360|NCT00751634|OG000|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
10938361|NCT00751634|EG000|Reported Event|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
10938362|NCT00751777|BG000|Baseline|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
10938363|NCT00751777|BG001|Baseline|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
10938364|NCT00751777|BG002|Baseline|Total|Total of all reporting groups
10938365|NCT00751777|FG000|Participant Flow|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
10938366|NCT00751777|FG001|Participant Flow|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
10938367|NCT00751777|OG000|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
10938368|NCT00751777|OG001|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
10938369|NCT00751777|EG000|Reported Event|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
10938370|NCT00751777|EG001|Reported Event|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
10938371|NCT00751790|BG000|Baseline|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
10938372|NCT00751790|FG000|Participant Flow|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
10938373|NCT00751790|OG000|Outcome|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
10938374|NCT00751790|EG000|Reported Event|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
10938375|NCT00751881|BG000|Baseline|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938376|NCT00751881|BG001|Baseline|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938377|NCT00751881|BG002|Baseline|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938378|NCT00751881|BG003|Baseline|Total|Total of all reporting groups
10938379|NCT00751881|FG000|Participant Flow|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938380|NCT00751881|FG001|Participant Flow|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938381|NCT00751881|FG002|Participant Flow|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938382|NCT00751881|OG000|Outcome|Placebo|Placebo once daily
10938383|NCT00751881|OG001|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
10938384|NCT00751881|OG002|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
10938385|NCT00751881|OG000|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938386|NCT00751881|OG001|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938387|NCT00751881|OG002|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
11192143|NCT02137486|FG001|Participant Flow|Final Kissing Ballooning|a balloon that extends from a position in the MV just proximal to the SB into a portion of the SB is inflated at the same time as the MV balloon; then treated with drug eluting stent or bare metal stent.
11192144|NCT02137486|OG000|Outcome|Sequential Ballooning|treated with drug eluting stent or bare metal stent.
10938388|NCT00751881|EG000|Reported Event|Placebo|Placebo once daily
10938389|NCT00751881|EG001|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
10938390|NCT00751881|EG002|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
10938391|NCT00751881|EG003|Reported Event|Placebo / 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily
10938392|NCT00751881|EG004|Reported Event|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938393|NCT00751881|EG005|Reported Event|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10938394|NCT00751972|BG000|Baseline|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
10938395|NCT00751972|BG001|Baseline|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS (NCT00119834) during the same enrollment period.
10938396|NCT00751972|BG002|Baseline|Total|Total of all reporting groups
10938397|NCT00751972|FG000|Participant Flow|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
10938398|NCT00751972|FG001|Participant Flow|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
10938399|NCT00751972|OG000|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
10938400|NCT00751972|OG001|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
10938401|NCT00751972|EG000|Reported Event|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
10938402|NCT00751998|BG000|Baseline|Arm 1|Test of SpyGlass device
10938403|NCT00751998|FG000|Participant Flow|Arm 1|Test of SpyGlass device
10938404|NCT00751998|OG000|Outcome|Arm 1|Test of SpyGlass device
10938405|NCT00751998|EG000|Reported Event|Arm 1|Test of SpyGlass device
10938406|NCT00752089|BG000|Baseline|Overall Study Participants|All randomized participants who received all four treatments NaF/ KNO3/ 2% isopentane Dentifrice, NaF/KNO3/ 0% isopentane Dentifrice, NaF Dentifrice, and placebo were included in the baseline assessment.
10938407|NCT00752089|FG000|Participant Flow|Overall Study|This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods.
10938408|NCT00752089|OG000|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
10938409|NCT00752089|OG001|Outcome|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
11192145|NCT02137486|OG001|Outcome|Final Kissing Ballooning|treated with drug eluting stent or bare metal stent.
10938410|NCT00752089|OG002|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
10938411|NCT00752089|OG003|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
10938412|NCT00752089|OG001|Outcome|NaF/ KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
10938413|NCT00752089|EG000|Reported Event|NaF/ KNO3/ 2 % Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
10938414|NCT00752089|EG001|Reported Event|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
10938415|NCT00752089|EG002|Reported Event|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
10938416|NCT00752089|EG003|Reported Event|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
10938417|NCT00752102|BG000|Baseline|Calcitriol|Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
10938418|NCT00752102|BG001|Baseline|Paricalcitol|Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
10938419|NCT00752102|BG002|Baseline|Total|Total of all reporting groups
10938420|NCT00752102|FG000|Participant Flow|Calcitriol|Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
10938421|NCT00752102|FG001|Participant Flow|Paricalcitol|Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
10938422|NCT00752102|OG000|Outcome|Calcitriol|Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
10938423|NCT00752102|OG001|Outcome|Paricalcitol|Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
10938424|NCT00752102|EG000|Reported Event|Calcitriol|Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
10938425|NCT00752102|EG001|Reported Event|Paricalcitol|Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
10938426|NCT00752128|BG000|Baseline|Resolute Drug-Eluting Stent|
10938427|NCT00752128|FG000|Participant Flow|Resolute Drug-Eluting Stent|
10938428|NCT00752128|OG000|Outcome|Cardiac Death or Target Vessel MI|Percentage of participants that had either Cardiac Death or Myocardial Infarction (not clearly attributable to a non-target vessel)
10938429|NCT00752128|OG000|Outcome|Overall Stent Thrombosis (Definite and Probable-ARC)|Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition
10938430|NCT00752128|EG000|Reported Event|Resolute Drug-Eluting Stent|
10938431|NCT00752206|BG000|Baseline|Saracatinib|"Saracatinib: Oral Agent~Administered once daily, oral dose of 175 mg for a 28 day cycle."
10938432|NCT00752206|BG001|Baseline|Placebo|"Placebo~Administered once daily, oral dose of 175 mg for a 28 day cycle."
10938433|NCT00752206|BG002|Baseline|Total|Total of all reporting groups
10938434|NCT00752206|FG000|Participant Flow|Saracatinib|"Saracatinib: Oral Agent~Administered once daily, oral dose of 175 mg for a 28 day cycle."
10938435|NCT00752206|FG001|Participant Flow|Placebo|"Placebo~Administered once daily, oral dose of 175 mg for a 28 day cycle."
10938436|NCT00752206|OG000|Outcome|Saracatinib|"Saracatinib: Oral Agent~Administered once daily, oral dose of 175 mg for a 28 day cycle."
10938437|NCT00752206|OG001|Outcome|Placebo|"Placebo~Administered once daily, oral dose of 175 mg for a 28 day cycle."
10938438|NCT00752206|EG000|Reported Event|Saracatinib|"Saracatinib: Oral Agent~Administered once daily, oral dose of 175 mg for a 28 day cycle."
10938439|NCT00752206|EG001|Reported Event|Placebo|Administered once daily, oral dose of 175 mg for a 28 day cycle.
10938440|NCT00752219|BG000|Baseline|NXL104/Ceftazidime + Metronidazole|Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
10938441|NCT00752219|BG001|Baseline|Meropenem|Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
10938442|NCT00752219|BG002|Baseline|Total|Total of all reporting groups
10938443|NCT00752219|FG000|Participant Flow|NXL104/Ceftazidime + Metronidazole|Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
10938444|NCT00752219|FG001|Participant Flow|Meropenem|Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
10938445|NCT00752219|OG000|Outcome|NXL104/Ceftazidime + Metronidazole|Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
10938446|NCT00752219|OG001|Outcome|Meropenem|Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
10938447|NCT00752219|EG000|Reported Event|NXL104/Ceftazidime + Metronidazole|Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
10938448|NCT00752219|EG001|Reported Event|Meropenem|Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy.
10938449|NCT00752232|BG000|Baseline|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938450|NCT00752232|BG001|Baseline|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
10938451|NCT00752232|BG002|Baseline|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
10938452|NCT00752232|BG003|Baseline|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
10938453|NCT00752232|BG004|Baseline|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10938454|NCT00752232|BG005|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938455|NCT00752232|BG006|Baseline|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
10938456|NCT00752232|BG007|Baseline|Total|Total of all reporting groups
10938457|NCT00752232|FG000|Participant Flow|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938458|NCT00752232|FG001|Participant Flow|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
10938459|NCT00752232|FG002|Participant Flow|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
10938460|NCT00752232|FG003|Participant Flow|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
10938461|NCT00752232|FG004|Participant Flow|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10938462|NCT00752232|FG005|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938463|NCT00752232|FG006|Participant Flow|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
10938464|NCT00752232|OG000|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938465|NCT00752232|OG001|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
10938466|NCT00752232|OG002|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
10938467|NCT00752232|OG003|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
10938468|NCT00752232|OG004|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10938469|NCT00752232|OG005|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938470|NCT00752232|OG006|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
10938471|NCT00752232|OG002|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938472|NCT00752232|EG000|Reported Event|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938473|NCT00752232|EG001|Reported Event|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
10938474|NCT00752232|EG002|Reported Event|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
10938475|NCT00752232|EG003|Reported Event|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 3, 6, 9 and 12
10938476|NCT00752232|EG004|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
10938477|NCT00752232|EG005|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
10938478|NCT00752232|EG006|Reported Event|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
10938479|NCT00752557|BG000|Baseline|Standard of Care Control|Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
10938480|NCT00752557|BG001|Baseline|rhBMP-2/CPM 1.0 mg/mL|Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938481|NCT00752557|BG002|Baseline|rhBMP-2/CPm 2.0 mg/mL|Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938482|NCT00752557|BG003|Baseline|Total|Total of all reporting groups
10938483|NCT00752557|FG000|Participant Flow|Standard of Care Control|Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
10938484|NCT00752557|FG001|Participant Flow|rhBMP-2/CPM 1.0 mg/mL|Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938485|NCT00752557|FG002|Participant Flow|rhBMP-2/CPM 2.0mg/mL|Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in both injected treatment groups additionally received SOC treatment for OP.
10938486|NCT00752557|OG000|Outcome|Standard of Care Control|Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
10938487|NCT00752557|OG001|Outcome|rhBMP-2/CPM 1.0 mg/mL|Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938488|NCT00752557|OG002|Outcome|rhBMP-2/CPm 2.0 mg/mL|Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938489|NCT00752557|OG000|Outcome|rhBMP-2/CPM 1.0 mg/mL|Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938490|NCT00752557|OG001|Outcome|rhBMP-2/CPm 2.0 mg/mL|Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938491|NCT00752557|EG000|Reported Event|Standard of Care Control|Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
10938492|NCT00752557|EG001|Reported Event|rhBMP-2/CPM 1.0 mg/mL|Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938493|NCT00752557|EG002|Reported Event|rhBMP-2/CPm 2.0 mg/mL|Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
10938494|NCT00752609|BG000|Baseline|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938495|NCT00752609|BG001|Baseline|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938496|NCT00752609|BG002|Baseline|Total|Total of all reporting groups
10938497|NCT00752609|FG000|Participant Flow|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938498|NCT00752609|FG001|Participant Flow|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938499|NCT00752609|OG000|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938500|NCT00752609|OG001|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938501|NCT00752609|OG000|Outcome|IV Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide intravenous (IV) injection once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938502|NCT00752609|OG001|Outcome|SC Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous (SC) injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938503|NCT00752609|OG002|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938504|NCT00752609|EG000|Reported Event|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938505|NCT00752609|EG001|Reported Event|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938506|NCT00752622|BG000|Baseline|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
10938507|NCT00752622|FG000|Participant Flow|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
10938508|NCT00752622|OG000|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
10938509|NCT00752622|EG000|Reported Event|Infliximab 5 mg/kg Then Not Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants who were further randomized into the interventional phase are not included in this reporting group; therefore, of the 100 enrolled participants, 92 participants were included in this safety reporting group.
10938510|NCT00752622|EG001|Reported Event|Infliximab 5 mg/kg Then Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants were then randomized to receive 5 mg/kg every 6 weeks (shortened interval group) or 7 mg/kg every 8 weeks (increased dose group) at entry into the interventional phase. This reporting group included 3 participants randomized into the shortened interval group and 5 participants randomized into the increased dose group.
10938511|NCT00752726|BG000|Baseline|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures.
10938512|NCT00752726|BG001|Baseline|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures.
10938513|NCT00752726|BG002|Baseline|Total|Total of all reporting groups
10938514|NCT00752726|FG000|Participant Flow|Orlistat 60 Milligram (mg)|Orlistat 60 mg capsules taken orally with meals 3 times per day
10938515|NCT00752726|FG001|Participant Flow|Placebo|Placebo to match orlistat 60 mg capsules taken orally with meals 3 times per day
10938516|NCT00752726|OG000|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
10938517|NCT00752726|OG001|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
10938518|NCT00752726|EG000|Reported Event|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
10938519|NCT00752726|EG001|Reported Event|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
10938520|NCT00752791|BG000|Baseline|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938521|NCT00752791|FG000|Participant Flow|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938522|NCT00752791|OG000|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938523|NCT00752791|EG000|Reported Event|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
10938524|NCT00752856|BG000|Baseline|1 - Kaletra + Isentress Taken Twice Daily|"Kaletra (lopinavir/ritonavir 400/100 mg) + Isentress (Raltegravir 400 mg) twice-daily~Kaletra + Isentress: kaletra 2 tabs twice a day + Raltegravir 1 tab twice a day"
10938525|NCT00752856|BG001|Baseline|2 - Atripla Taken Once Daily|"Sustiva (EFV 600 mg), Viread (TDF 300 mg) and Emtriva (FTC 200 mg) taken as Atripla® once-daily~Atripla: Atripla 1 tab once a day"
10938526|NCT00752856|BG002|Baseline|Total|Total of all reporting groups
10938527|NCT00752856|FG000|Participant Flow|1 - Kaletra + Isentress Taken Twice Daily|"Kaletra (lopinavir/ritonavir 400/100 mg) + Isentress (Raltegravir 400 mg) twice-daily~Kaletra + Isentress: kaletra 2 tabs twice a day + Raltegravir 1 tab twice a day"
10938528|NCT00752856|FG001|Participant Flow|2 - Atripla Taken Once Daily|"Sustiva (EFV 600 mg), Viread (TDF 300 mg) and Emtriva (FTC 200 mg) taken as Atripla® once-daily~Atripla: Atripla 1 tab once a day"
10938529|NCT00752856|OG000|Outcome|1 - Kaletra + Isentress Taken Twice Daily|"Kaletra (lopinavir/ritonavir 400/100 mg) + Isentress (Raltegravir 400 mg) twice-daily~Kaletra + Isentress: kaletra 2 tabs twice a day + Raltegravir 1 tab twice a day"
10938530|NCT00752856|OG001|Outcome|2 - Atripla Taken Once Daily|"Sustiva (EFV 600 mg), Viread (TDF 300 mg) and Emtriva (FTC 200 mg) taken as Atripla® once-daily~Atripla: Atripla 1 tab once a day"
10938531|NCT00752856|EG000|Reported Event|1 - Kaletra + Isentress Taken Twice Daily|"Kaletra (lopinavir/ritonavir 400/100 mg) + Isentress (Raltegravir 400 mg) twice-daily~Kaletra + Isentress: kaletra 2 tabs twice a day + Raltegravir 1 tab twice a day"
10938532|NCT00752856|EG001|Reported Event|2 - Atripla Taken Once Daily|"Sustiva (EFV 600 mg), Viread (TDF 300 mg) and Emtriva (FTC 200 mg) taken as Atripla® once-daily~Atripla: Atripla 1 tab once a day"
10938533|NCT00752895|BG000|Baseline|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
10938534|NCT00752895|BG001|Baseline|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
10938535|NCT00752895|BG002|Baseline|Total|Total of all reporting groups
10938536|NCT00752895|FG000|Participant Flow|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
10938537|NCT00752895|FG001|Participant Flow|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
10938538|NCT00752895|OG000|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
10938539|NCT00752895|OG001|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
10938540|NCT00752895|EG000|Reported Event|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
10938541|NCT00752895|EG001|Reported Event|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
10938542|NCT00752908|BG000|Baseline|Obese Patients|Obese patients
10938543|NCT00752908|BG001|Baseline|Normal Weight Patients and Volunteers|Normal weight patients and volunteers
10938544|NCT00752908|BG002|Baseline|Total|Total of all reporting groups
10938545|NCT00752908|FG000|Participant Flow|Obese Patients|Obese patients
10938546|NCT00752908|FG001|Participant Flow|Normal Weight Patients and Volunteers|Normal weight patients and volunteers
10938547|NCT00752908|OG000|Outcome|Obese Patients|Obese patients
10938548|NCT00752908|OG001|Outcome|Normal Weight Patients and Volunteers|Normal weight patients and volunteers
10938549|NCT00752908|EG000|Reported Event|Obese Patients|Obese patients
10938550|NCT00752908|EG001|Reported Event|Normal Weight Patients and Volunteers|Normal weight patients and volunteers
10938551|NCT00752973|BG000|Baseline|MALG Treatment Arm|"MALG treatment~MALG (malathion) Treatment: MALG applied for 30 minutes"
10938552|NCT00752973|FG000|Participant Flow|Malathion Gel 0.5% Treatment Arm|"Malathion Gel 0.5% treatment~MALG (Malathion Gel 0.5%) Treatment: MALG applied for 30 minutes"
10938553|NCT00752973|OG000|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
10938554|NCT00752973|OG000|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~A subject had out of range (low) RBC cholinesterase value 1 h post treatment. This value was considered to be not clinically significant by the investigator."
10938555|NCT00752973|OG000|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
10938556|NCT00752973|EG000|Reported Event|MALG Treatment Arm|"MALG treatment~MALG (malathion) Treatment: MALG applied for 30 minutes"
10938557|NCT00753012|BG000|Baseline|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
10938558|NCT00753012|BG001|Baseline|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
10938559|NCT00753012|BG002|Baseline|Total|Total of all reporting groups
10938560|NCT00753012|FG000|Participant Flow|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
10938561|NCT00753012|FG001|Participant Flow|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
10938562|NCT00753012|OG000|Outcome|Normotensive Adults With ADHD|
10938563|NCT00753012|OG001|Outcome|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
10938564|NCT00753012|OG001|Outcome|Primary Hypertensive Adults With ADHD|
10938565|NCT00753012|EG000|Reported Event|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
10938566|NCT00753012|EG001|Reported Event|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
10938567|NCT00753142|BG000|Baseline|Ketosis-prone Diabetics|Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938568|NCT00753142|BG001|Baseline|Ketosis-resistant Diabetics|Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938569|NCT00753142|BG002|Baseline|Non-diabetic Control Group|Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938570|NCT00753142|BG003|Baseline|Total|Total of all reporting groups
11176706|NCT02037568|EG001|Reported Event|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
11176707|NCT02037607|BG000|Baseline|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound within 48 hours prior to surgery and a repeat within 72 hours after surgery.
10938571|NCT00753142|FG000|Participant Flow|Ketosis-prone Diabetics|Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938572|NCT00753142|FG001|Participant Flow|Ketosis-resistant Diabetics|Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938573|NCT00753142|FG002|Participant Flow|Non-diabetic Control Group|Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938574|NCT00753142|OG000|Outcome|Ketosis-prone Diabetics|Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938575|NCT00753142|OG001|Outcome|Ketosis-resistant Diabetics|Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938576|NCT00753142|OG002|Outcome|Non-diabetic Control Group|Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938577|NCT00753142|EG000|Reported Event|Ketosis-prone Diabetics|Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938578|NCT00753142|EG001|Reported Event|Ketosis-resistant Diabetics|Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938579|NCT00753142|EG002|Reported Event|Non-diabetic Control Group|Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m^2/min for 20 hours.
10938580|NCT00753220|BG000|Baseline|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
10938581|NCT00753220|FG000|Participant Flow|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
10938582|NCT00753220|OG000|Outcome|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
10938583|NCT00753220|EG000|Reported Event|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
10938584|NCT00753272|BG000|Baseline|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
10938585|NCT00753272|BG001|Baseline|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
10938586|NCT00753272|BG002|Baseline|Total|Total of all reporting groups
10938587|NCT00753272|FG000|Participant Flow|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
10938588|NCT00753272|FG001|Participant Flow|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
10938589|NCT00753272|OG000|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
10938590|NCT00753272|OG001|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
10938591|NCT00753272|OG000|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
10938592|NCT00753272|OG001|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
10938593|NCT00753272|OG002|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
10938594|NCT00753272|EG000|Reported Event|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
10938595|NCT00753272|EG001|Reported Event|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
10938596|NCT00753298|BG000|Baseline|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
10938597|NCT00753298|BG001|Baseline|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
10938598|NCT00753298|BG002|Baseline|Total|Total of all reporting groups
10938599|NCT00753298|FG000|Participant Flow|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
10938600|NCT00753298|FG001|Participant Flow|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
10938601|NCT00753298|OG000|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
10938602|NCT00753298|OG001|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
10938603|NCT00753298|EG000|Reported Event|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
10938604|NCT00753298|EG001|Reported Event|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
10938605|NCT00753337|BG000|Baseline|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
10938606|NCT00753337|FG000|Participant Flow|Assurant Cobalt Iliac Stent|Cobalt stent implanted using standard percutaneous intervention technique.
10938607|NCT00753337|OG000|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
10938608|NCT00753337|OG000|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting.
10938609|NCT00753337|EG000|Reported Event|Assurant Cobalt Iliac Stent|Treatment with Iliac stenting system
10938610|NCT00753363|BG000|Baseline|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
10938611|NCT00753363|BG001|Baseline|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
11176708|NCT02037607|FG000|Participant Flow|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
11176709|NCT02037607|OG000|Outcome|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
10938612|NCT00753363|BG002|Baseline|Total|Total of all reporting groups
10938613|NCT00753363|FG000|Participant Flow|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
10938614|NCT00753363|FG001|Participant Flow|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
10938615|NCT00753363|OG000|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
10938616|NCT00753363|OG001|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
10938617|NCT00753363|EG000|Reported Event|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
10938618|NCT00753363|EG001|Reported Event|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
10938619|NCT00753415|BG000|Baseline|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
10938620|NCT00753415|BG001|Baseline|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
10938621|NCT00753415|BG002|Baseline|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
10938622|NCT00753415|BG003|Baseline|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
10938623|NCT00753415|BG004|Baseline|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
10938624|NCT00753415|BG005|Baseline|Total|Total of all reporting groups
10938625|NCT00753415|FG000|Participant Flow|Part A: V935 LD|Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
10938626|NCT00753415|FG001|Participant Flow|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
10938627|NCT00753415|FG002|Participant Flow|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
10938628|NCT00753415|FG003|Participant Flow|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
10938629|NCT00753415|FG004|Participant Flow|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
10938630|NCT00753415|FG005|Participant Flow|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
10938631|NCT00753415|FG006|Participant Flow|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938632|NCT00753415|FG007|Participant Flow|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938633|NCT00753415|FG008|Participant Flow|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938634|NCT00753415|FG009|Participant Flow|Part B: V934 HD(5)+V934 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938635|NCT00753415|OG000|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
10938636|NCT00753415|OG001|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
10938637|NCT00753415|OG002|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
10938638|NCT00753415|OG003|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
10938639|NCT00753415|OG004|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
10938640|NCT00753415|OG005|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938641|NCT00753415|OG006|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938642|NCT00753415|OG007|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938643|NCT00753415|OG008|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938644|NCT00753415|OG009|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938645|NCT00753415|OG005|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938646|NCT00753415|OG007|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.
10938647|NCT00753415|EG000|Reported Event|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
10938648|NCT00753415|EG001|Reported Event|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
10938649|NCT00753415|EG002|Reported Event|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
10938650|NCT00753415|EG003|Reported Event|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
10938651|NCT00753415|EG004|Reported Event|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
10938652|NCT00753415|EG005|Reported Event|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938653|NCT00753415|EG006|Reported Event|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938654|NCT00753415|EG007|Reported Event|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938655|NCT00753415|EG008|Reported Event|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938656|NCT00753415|EG009|Reported Event|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
10938657|NCT00753454|BG000|Baseline|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
11176710|NCT02037607|EG000|Reported Event|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
11176711|NCT02037776|BG000|Baseline|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
10938658|NCT00753454|FG000|Participant Flow|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
11176712|NCT02037776|BG001|Baseline|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
11176713|NCT02037776|BG002|Baseline|Total|Total of all reporting groups
10938659|NCT00753454|OG000|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
10938660|NCT00753454|EG000|Reported Event|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
10938661|NCT00753506|BG000|Baseline|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
10938662|NCT00753506|BG001|Baseline|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
10938663|NCT00753506|BG002|Baseline|Total|Total of all reporting groups
10938664|NCT00753506|FG000|Participant Flow|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
10938665|NCT00753506|FG001|Participant Flow|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
10938666|NCT00753506|OG000|Outcome|Artemisinin|100 mg capsule of artemisinin taken twice per day.
10938667|NCT00753506|OG001|Outcome|Placebo|100 mg artemisinin identical placebo capsule taken twice per day.
10938668|NCT00753506|EG000|Reported Event|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
10938669|NCT00753506|EG001|Reported Event|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
10938670|NCT00753519|BG000|Baseline|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
10938671|NCT00753519|BG001|Baseline|Sham iTBS|Sham iTBS
10938672|NCT00753519|BG002|Baseline|Total|Total of all reporting groups
10938673|NCT00753519|FG000|Participant Flow|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
10938674|NCT00753519|FG001|Participant Flow|Sham iTBS|Sham iTBS
10938675|NCT00753519|OG000|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
10938676|NCT00753519|OG001|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
10938677|NCT00753519|OG002|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
10938678|NCT00753519|OG003|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
10938679|NCT00753519|EG000|Reported Event|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
10938680|NCT00753519|EG001|Reported Event|Sham iTBS|Sham iTBS
10938681|NCT00753623|BG000|Baseline|Placebo Phase I; Ramelteon Phase II|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.~Ramelteon : ramelteon (8 mg)"
10938682|NCT00753623|BG001|Baseline|Ramelton Phase I; Placebo Phase II|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.~Ramelteon : ramelteon (8 mg)"
10938683|NCT00753623|BG002|Baseline|Total|Total of all reporting groups
10938684|NCT00753623|FG000|Participant Flow|Placebo Phase I; Ramelteon Phase II|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.~Ramelteon : ramelteon (8 mg)"
10938685|NCT00753623|FG001|Participant Flow|Ramelton Phase I; Placebo Phase II|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.~Ramelteon : ramelteon (8 mg)"
10938686|NCT00753623|OG000|Outcome|Ramelteon|Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
10938687|NCT00753623|OG001|Outcome|Placebo|Participants who received placebo medication during the first or last 2 weeks of the study.
10938688|NCT00753623|EG000|Reported Event|Ramelteon|Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
10938689|NCT00753623|EG001|Reported Event|Placebo|Participants who received placebo medication during the first or last 2 weeks of the study.
10938690|NCT00753636|BG000|Baseline|Isradipine 20mg, 15mg, 10mg or 5 mg|
10938691|NCT00753636|FG000|Participant Flow|Isradipine 20mg, 15mg, 10mg or 5 mg|
10938692|NCT00753636|OG000|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
10938693|NCT00753636|EG000|Reported Event|Isradipine 20mg, 15mg, 10mg or 5 mg|A group is defined by the highest dose received by the subject. Subjects are started at 5mg dose, and may end at the highest dose of 20mg, depending on how they tolerate the drug. Thus, assignment to a group is not randomized but relies on the last/highest dose received.
10938694|NCT00753649|BG000|Baseline|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
10938695|NCT00753649|BG001|Baseline|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
10938696|NCT00753649|BG002|Baseline|Total|Total of all reporting groups
10938697|NCT00753649|FG000|Participant Flow|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
10938698|NCT00753649|FG001|Participant Flow|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
10938699|NCT00753649|OG000|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
10938700|NCT00753649|OG001|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
10938701|NCT00753649|EG000|Reported Event|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
10938702|NCT00753649|EG001|Reported Event|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
10938703|NCT00753675|BG000|Baseline|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
10938704|NCT00753675|BG001|Baseline|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
10938705|NCT00753675|BG002|Baseline|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
10938706|NCT00753675|BG003|Baseline|Total|Total of all reporting groups
10938707|NCT00753675|FG000|Participant Flow|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
10938708|NCT00753675|FG001|Participant Flow|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
10938709|NCT00753675|FG002|Participant Flow|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
10938710|NCT00753675|OG000|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
10938711|NCT00753675|OG001|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
10938712|NCT00753675|OG002|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
10938713|NCT00753675|EG000|Reported Event|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
10938714|NCT00753675|EG001|Reported Event|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
10938715|NCT00753675|EG002|Reported Event|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
10938716|NCT00753688|BG000|Baseline|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
10938717|NCT00753688|BG001|Baseline|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
10938718|NCT00753688|BG002|Baseline|Total|Total of all reporting groups
10938719|NCT00753688|FG000|Participant Flow|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
10938720|NCT00753688|FG001|Participant Flow|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
10938721|NCT00753688|OG000|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
10938722|NCT00753688|OG001|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
10938723|NCT00753688|EG000|Reported Event|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
10938724|NCT00753688|EG001|Reported Event|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
10938725|NCT00753714|BG000|Baseline|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
10938726|NCT00753714|BG001|Baseline|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
10938727|NCT00753714|BG002|Baseline|Total|Total of all reporting groups
10938728|NCT00753714|FG000|Participant Flow|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
10938729|NCT00753714|FG001|Participant Flow|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
11176714|NCT02037776|FG000|Participant Flow|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
11176715|NCT02037776|FG001|Participant Flow|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
11176716|NCT02037776|OG000|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
10938730|NCT00753714|OG000|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
10938731|NCT00753714|OG001|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
10938732|NCT00753714|OG000|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
10938733|NCT00753714|OG000|Outcome|ZD6474 ( (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
10938734|NCT00753714|OG001|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
10938735|NCT00753714|EG000|Reported Event|ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
10938736|NCT00753714|EG001|Reported Event|Placebo to Match ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
10938737|NCT00753766|BG000|Baseline|Multifactorial Intervention|Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
10938738|NCT00753766|BG001|Baseline|Usual Care|Control group
10938739|NCT00753766|BG002|Baseline|Total|Total of all reporting groups
10938740|NCT00753766|FG000|Participant Flow|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
10938741|NCT00753766|FG001|Participant Flow|Usual Care|Control group
10938742|NCT00753766|OG000|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
10938743|NCT00753766|OG001|Outcome|Usual Care|Control group
10938744|NCT00753766|OG000|Outcome|Multifactorial Intervention|"Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.~Multifactorial Intervention"
10938745|NCT00753766|EG000|Reported Event|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
10938746|NCT00753766|EG001|Reported Event|Usual Care|Control group
10938747|NCT00753896|BG000|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
10938748|NCT00753896|FG000|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
10938749|NCT00753896|OG000|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
11176717|NCT02037776|OG001|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
10938750|NCT00753896|EG000|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
10938751|NCT00753922|BG000|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
10938752|NCT00753922|BG001|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
10938753|NCT00753922|BG002|Baseline|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
11176718|NCT02037776|EG000|Reported Event|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
10938754|NCT00753922|BG003|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
10938755|NCT00753922|BG004|Baseline|Total|Total of all reporting groups
10938756|NCT00753922|FG000|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
10938757|NCT00753922|FG001|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
10938758|NCT00753922|FG002|Participant Flow|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
10938759|NCT00753922|FG003|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
10938760|NCT00753922|OG000|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
10938761|NCT00753922|OG001|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
10938762|NCT00753922|OG002|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
10938763|NCT00753922|OG003|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
10938764|NCT00753922|EG000|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
10938765|NCT00753922|EG001|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
10938766|NCT00753922|EG002|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
10938767|NCT00753922|EG003|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
10938768|NCT00753935|BG000|Baseline|Enteric-coated Aspirin|patients with coronary artery disease received enteric-coated aspirin 81 mg qd for 2 weeks
10938769|NCT00753935|BG001|Baseline|Chewable Aspirin|Patients with coronary artery disease received chewable aspirin 81 mg qd for 2 weeks
10938770|NCT00753935|BG002|Baseline|Total|Total of all reporting groups
10938771|NCT00753935|FG000|Participant Flow|Enteric-coated Aspirin|"patients received enteric-coated aspirin 81 mg qd for 2 weeks~enteric-coated aspirin: enteric-coated aspirin 81mg daily for 2 weeks"
11176719|NCT02037776|EG001|Reported Event|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
10938772|NCT00753935|FG001|Participant Flow|Chewable Aspirin|"Patients received chewable aspirin 81 mg qd for 2 weeks~Chewable aspirin: chewable aspirin 81mg daily for 2 weeks"
10938773|NCT00753935|OG000|Outcome|Enteric-coated Aspirin|"patients received enteric-coated aspirin 81 mg qd for 2 weeks~enteric-coated aspirin: enteric-coated aspirin 81mg daily for 2 weeks"
10938774|NCT00753935|OG001|Outcome|Chewable Aspirin|"Patients received chewable aspirin 81 mg qd for 2 weeks~Chewable aspirin: chewable aspirin 81mg daily for 2 weeks"
10938775|NCT00753935|EG000|Reported Event|Enteric-coated Aspirin|patients with coronary artery disease received enteric-coated aspirin 81 mg qd for 2 weeks
10938776|NCT00753935|EG001|Reported Event|Chewable Aspirin|Patients with coronary artery disease received chewable aspirin 81 mg qd for 2 weeks
10938777|NCT00753948|BG000|Baseline|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938778|NCT00753948|BG001|Baseline|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938779|NCT00753948|BG002|Baseline|Healthy Controls|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938780|NCT00753948|BG003|Baseline|Total|Total of all reporting groups
10938781|NCT00753948|FG000|Participant Flow|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938782|NCT00753948|FG001|Participant Flow|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938783|NCT00753948|FG002|Participant Flow|Healthy Control|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938784|NCT00753948|OG000|Outcome|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938785|NCT00753948|OG001|Outcome|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938786|NCT00753948|OG002|Outcome|Healthy Controls|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938787|NCT00753948|EG000|Reported Event|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938788|NCT00753948|EG001|Reported Event|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938789|NCT00753948|EG002|Reported Event|Healthy Control|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
10938790|NCT00754065|BG000|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
10938791|NCT00754065|BG001|Baseline|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
10938792|NCT00754065|BG002|Baseline|Total|Total of all reporting groups
10938793|NCT00754065|FG000|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
10938794|NCT00754065|FG001|Participant Flow|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
10938795|NCT00754065|OG000|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
10938796|NCT00754065|OG001|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
10938797|NCT00754065|EG000|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated)
10938798|NCT00754065|EG001|Reported Event|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
10938799|NCT00754130|BG000|Baseline|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
10938800|NCT00754130|BG001|Baseline|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
10938801|NCT00754130|BG002|Baseline|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
10938802|NCT00754130|BG003|Baseline|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
10938803|NCT00754130|BG004|Baseline|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
10938804|NCT00754130|BG005|Baseline|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
10938805|NCT00754130|BG006|Baseline|Total|Total of all reporting groups
10938806|NCT00754130|FG000|Participant Flow|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
10938807|NCT00754130|FG001|Participant Flow|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
10938808|NCT00754130|FG002|Participant Flow|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
10938809|NCT00754130|FG003|Participant Flow|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
10938810|NCT00754130|FG004|Participant Flow|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
10938811|NCT00754130|FG005|Participant Flow|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
10938812|NCT00754130|OG000|Outcome|Placebo|Participants receiving Placebo doses three times daily
10938813|NCT00754130|OG001|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
10938814|NCT00754130|OG002|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
10938815|NCT00754130|OG003|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
10938816|NCT00754130|OG004|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
10938817|NCT00754130|OG000|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
10938818|NCT00754130|OG001|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
10938819|NCT00754130|OG002|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
10938820|NCT00754130|OG003|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
10938821|NCT00754130|EG000|Reported Event|Placebo|Participants receiving Placebo doses three times daily
10938822|NCT00754130|EG001|Reported Event|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
10938823|NCT00754130|EG002|Reported Event|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
10938824|NCT00754130|EG003|Reported Event|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
10938825|NCT00754130|EG004|Reported Event|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
10938826|NCT00754156|BG000|Baseline|1 ABRA Plus V.A.C or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy
10938827|NCT00754156|BG001|Baseline|V.A.C. or ABThera|V.A.C. or ABThera Therapy alone
10938828|NCT00754156|BG002|Baseline|Total|Total of all reporting groups
10938829|NCT00754156|FG000|Participant Flow|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
10938830|NCT00754156|FG001|Participant Flow|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
10938831|NCT00754156|OG000|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
10938832|NCT00754156|OG001|Outcome|2 ABThera|ABThera V.A.C. Therapy alone
10938833|NCT00754156|OG000|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C or ABThera V.A.C. Therapy
10938834|NCT00754156|OG001|Outcome|2 ABThera|V.A.C. or ABThera V.A.C. Therapy alone
10938835|NCT00754156|OG000|Outcome|1 ABRA Plus V.A.C. or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or ABThera V.A.C. Therapy
10938836|NCT00754156|OG001|Outcome|2 V.A.C. or ABThera Alone|V.A.C. or ABThera V.A.C. Therapy alone
10938837|NCT00754156|OG000|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
10938838|NCT00754156|OG001|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
10938839|NCT00754156|EG000|Reported Event|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
10938840|NCT00754156|EG001|Reported Event|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
10938841|NCT00754208|BG000|Baseline|Ritalin LA for ADHD|4 and 5 year old subjects with ADHD
10938842|NCT00754208|FG000|Participant Flow|Ritalin LA for ADHD|Subjects treated with Ritalin LA for ADHD
10938843|NCT00754208|OG000|Outcome|Group 1|All subjects treated with open-label methylphenidate (Ritalin LA)
10938844|NCT00754208|OG000|Outcome|Group 1|All subjects treated with open-label methylphenidate
10938845|NCT00754208|EG000|Reported Event|Methylpehnidate|"open-label treatment with methylphenidate~methylphenidate: Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day."
10938846|NCT00754234|BG000|Baseline|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
10938847|NCT00754234|FG000|Participant Flow|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
10938848|NCT00754234|OG000|Outcome|MyPyramid Menu|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
10938849|NCT00754234|EG000|Reported Event|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
10938850|NCT00754247|BG000|Baseline|0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )|"0.5% hydrocortisone, silicone, vitamin E lotion~0.5% hydrocortisone, silicone, vitamin E lotion: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing."
10938851|NCT00754247|BG001|Baseline|Onion Extract Gel (OE)|"Onion extract gel~Onion extract gel: Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks."
10938852|NCT00754247|BG002|Baseline|Cetearyl Alcohol Lotion (Placebo)|"Cetearyl alcohol lotion~Cetearyl alcohol lotion: Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion."
10938853|NCT00754247|BG003|Baseline|Total|Total of all reporting groups
10938854|NCT00754247|FG000|Participant Flow|0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )|"0.5% hydrocortisone, silicone, vitamin E lotion~0.5% hydrocortisone, silicone, vitamin E lotion: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing."
10938855|NCT00754247|FG001|Participant Flow|Onion Extract Gel (OE)|"Onion extract gel~Onion extract gel: Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks."
10938856|NCT00754247|FG002|Participant Flow|Cetearyl Alcohol Lotion (Placebo)|"Cetearyl alcohol lotion~Cetearyl alcohol lotion: Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion."
10938857|NCT00754247|OG000|Outcome|0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )|"0.5% hydrocortisone, silicone, vitamin E lotion~0.5% hydrocortisone, silicone, vitamin E lotion: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing."
10938858|NCT00754247|OG001|Outcome|Onion Extract Gel (OE)|"Onion extract gel~Onion extract gel: Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks."
10938859|NCT00754247|OG002|Outcome|Cetearyl Alcohol Lotion (Placebo)|"Cetearyl alcohol lotion~Cetearyl alcohol lotion: Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion."
10938860|NCT00754247|EG000|Reported Event|0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )|"0.5% hydrocortisone, silicone, vitamin E lotion~0.5% hydrocortisone, silicone, vitamin E lotion: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing."
10938861|NCT00754247|EG001|Reported Event|Onion Extract Gel (OE)|"Onion extract gel~Onion extract gel: Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks."
10938862|NCT00754247|EG002|Reported Event|Cetearyl Alcohol Lotion (Placebo)|"Cetearyl alcohol lotion~Cetearyl alcohol lotion: Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion."
10938863|NCT00754325|BG000|Baseline|Fulvestrant and Dasatinib|"Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
10938864|NCT00754325|BG001|Baseline|Fulvestrant|"Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
10938865|NCT00754325|BG002|Baseline|Total|Total of all reporting groups
10938866|NCT00754325|FG000|Participant Flow|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
10938867|NCT00754325|FG001|Participant Flow|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
10938868|NCT00754325|OG000|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
10938869|NCT00754325|OG001|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
10938870|NCT00754325|EG000|Reported Event|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
10938871|NCT00754325|EG001|Reported Event|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
10938872|NCT00754325|EG002|Reported Event|Fulvestrant Crossover to Fulvestrant and Dasatinib|"Arm 2b: Participants in this group started on the Fulvestrant only arm and later started receiving a drug regimen that consisted of both fulvestrant and dasatinib. These participants are all inclusive and not limited to Fulvestrant or Fulvestrant and Dasatinib treatment only. The timeframe for when these events occurred were not immediately available and may have been caused by previous exposure to Fulvestrant only (pre-crossover), therefore the events for this patient population are also reported separately.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
10938873|NCT00754338|BG000|Baseline|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
10938874|NCT00754338|BG001|Baseline|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
10938875|NCT00754338|BG002|Baseline|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
10938876|NCT00754338|BG003|Baseline|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
10938877|NCT00754338|BG004|Baseline|Total|Total of all reporting groups
10938878|NCT00754338|FG000|Participant Flow|Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
10938879|NCT00754338|FG001|Participant Flow|Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
10938880|NCT00754338|FG002|Participant Flow|Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
10938881|NCT00754338|FG003|Participant Flow|Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
10938882|NCT00754338|OG000|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
10938883|NCT00754338|OG001|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
10938884|NCT00754338|OG002|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
10938885|NCT00754338|OG003|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
10938886|NCT00754338|OG000|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
10938887|NCT00754338|OG001|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
10938888|NCT00754338|EG000|Reported Event|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
10938889|NCT00754338|EG001|Reported Event|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
10938890|NCT00754338|EG002|Reported Event|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
10938891|NCT00754338|EG003|Reported Event|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
10938892|NCT00754377|BG000|Baseline|PBLI Curriculum Group|Received PBLI curriculum to evaluate and develop tools.
10938893|NCT00754377|BG001|Baseline|Comparison Group|Didn't receive intervention
10938894|NCT00754377|BG002|Baseline|Total|Total of all reporting groups
10938895|NCT00754377|FG000|Participant Flow|PBL Curriculum Group|"To evaluate preliminary data on a PBLI curriculum grounded on QI system projects.~PBLI curriculum comparison: The design is a pre-post comparison of PBLI curriculum participants versus non-participants. Data will come from the closed-ended items on the questionnaire given before the rotation and at the end of the rotation. PBLI curriculum was offered on alternate rotations (residents on alternate month were involved with a different curriculum). Preliminary data is available from 11 blocks, 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42) during the previous academic year. Closed-ended items assessed beliefs about different aspects of Continuous Quality Improvement (CQI) project development and implementation (6 items). In addition, there were 5 short definition items to address knowledge. Finally, content analysis methods will be used to evaluate responses to the open-ended item which asked respondents to develop a project to improve patient care."
10938896|NCT00754377|FG001|Participant Flow|Comparison Group|Alternate rotations and didn't receive intervention
10938897|NCT00754377|OG000|Outcome|PBLI Curriculum Group|Received the intervention and used to evaluate and develop PBLI tools
10938898|NCT00754377|OG001|Outcome|Comparison Group|Didn't receive intervention
10938899|NCT00754377|OG000|Outcome|PBLI Curriclum Group|Received the intervention and evaluate and develop PBLI tools
10938900|NCT00754377|OG001|Outcome|Comparison Group|Didn't receive the intervention.
10938901|NCT00754377|EG000|Reported Event|PBLI Curriculum Group|Received the intervention. To evaluate and develop PBLI tools.
10938902|NCT00754377|EG001|Reported Event|Comparison Group|Didn't receive the intervention
10938903|NCT00754390|BG000|Baseline|Entire Study Population|Includes all subjects randomized to the 4 treatments. Treatments were assigned in randomized order so the number of subjects starting the study does not equal the starting number for a given treatment
10938904|NCT00754390|FG000|Participant Flow|Calcium and Phytate Interactions|Subjects consumed 4 test meals (Moderate Calcium (Ca),Low Phytate; Moderate Ca,High Phytate; High Ca,Low Phytate; High Ca,High Phytate) in random order
10938905|NCT00754390|OG000|Outcome|Moderate Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 440 milligrams of phytate per day
10938906|NCT00754390|OG001|Outcome|Moderate Calcium, High Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 1800 milligrams of phytate per day
10938907|NCT00754390|OG002|Outcome|High Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day
10938908|NCT00754390|OG003|Outcome|High Calcium, High Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day
10938909|NCT00754390|EG000|Reported Event|Overall Study|Participants consumed 4 dietary treatments in randomized order
10938910|NCT00754442|BG000|Baseline|Controls|controls with normal PTH
10938911|NCT00754442|BG001|Baseline|Patient Group|patients with secondary hyperparathyroidism
10938912|NCT00754442|BG002|Baseline|Total|Total of all reporting groups
10938913|NCT00754442|FG000|Participant Flow|Controls|controls with normal PTH
10938914|NCT00754442|FG001|Participant Flow|Patient Group|patients with secondary hyperparathyroidism
10938915|NCT00754442|OG000|Outcome|Group 1|"patients with secondary hyperparathyroidism"
10938916|NCT00754442|OG001|Outcome|Controls|Controls without secondary hyperparathyroidism
10938917|NCT00754442|OG000|Outcome|Patients|patients with idiopathic secondary hyperparathyroidism
11176720|NCT02037893|BG000|Baseline|Antipyrine and Benzocaine Otic Solution|"antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176721|NCT02037893|BG001|Baseline|Antipyrine Otic Solution|"Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176722|NCT02037893|BG002|Baseline|Benzocaine Otic Solution|"benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176723|NCT02037893|BG003|Baseline|Placebo|"Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176724|NCT02037893|BG004|Baseline|Total|Total of all reporting groups
11176725|NCT02037893|FG000|Participant Flow|Antipyrine and Benzocaine Otic Solution|"antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176726|NCT02037893|FG001|Participant Flow|Antipyrine Otic Solution|"Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176727|NCT02037893|FG002|Participant Flow|Benzocaine Otic Solution|"benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176728|NCT02037893|FG003|Participant Flow|Placebo|"Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176729|NCT02037893|OG000|Outcome|Antipyrine and Benzocaine Otic Solution|"antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176730|NCT02037893|OG001|Outcome|Antipyrine Otic Solution|"Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176731|NCT02037893|OG002|Outcome|Benzocaine Otic Solution|"benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176732|NCT02037893|OG003|Outcome|Placebo|"Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176733|NCT02037893|EG000|Reported Event|Antipyrine and Benzocaine Otic Solution|"antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Antipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176734|NCT02037893|EG001|Reported Event|Antipyrine Otic Solution|"Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Antipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176735|NCT02037893|EG002|Reported Event|Benzocaine Otic Solution|"benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Benzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176736|NCT02037893|EG003|Reported Event|Placebo|"Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping~Placebo Otic solution: Placebo otic solution will be glycerin that is dehydrated"
11176737|NCT02037984|BG000|Baseline|Adult V114: 1x:1x:1x|On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
11176738|NCT02037984|BG001|Baseline|Adult V114: 2x.2x.2x|On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
10938918|NCT00754442|EG000|Reported Event|Controls|controls with normal PTH
10938919|NCT00754442|EG001|Reported Event|Patient Group|patients with secondary hyperparathyroidism
10938920|NCT00754468|BG000|Baseline|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
10938921|NCT00754468|BG001|Baseline|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
10938922|NCT00754468|BG002|Baseline|Total|Total of all reporting groups
10938923|NCT00754468|FG000|Participant Flow|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
10938924|NCT00754468|FG001|Participant Flow|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
10938925|NCT00754468|OG000|Outcome|Group 1: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds~Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment"
10938926|NCT00754468|OG001|Outcome|Group 2: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 2 cycles x20 seconds~Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds"
10938927|NCT00754468|OG000|Outcome|Group 1: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment
10938928|NCT00754468|OG001|Outcome|Group 2: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds
10938929|NCT00754468|EG000|Reported Event|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
10938930|NCT00754468|EG001|Reported Event|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
10938931|NCT00754494|BG000|Baseline|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11176739|NCT02037984|BG002|Baseline|Infant V114: 1x:1x:1x|Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
10938932|NCT00754494|BG001|Baseline|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10938933|NCT00754494|BG002|Baseline|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10938934|NCT00754494|BG003|Baseline|Total|Total of all reporting groups
10938935|NCT00754494|FG000|Participant Flow|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10938936|NCT00754494|FG001|Participant Flow|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10938937|NCT00754494|FG002|Participant Flow|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10938938|NCT00754494|OG000|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
10938939|NCT00754494|OG001|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
10938940|NCT00754494|OG002|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
10938941|NCT00754494|EG000|Reported Event|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10938942|NCT00754494|EG001|Reported Event|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10938943|NCT00754494|EG002|Reported Event|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10938944|NCT00754546|BG000|Baseline|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:~Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
10938945|NCT00754546|FG000|Participant Flow|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:~Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
10938946|NCT00754546|OG000|Outcome|Treadmill Exercise With the Active Comparator|
10938947|NCT00754546|OG001|Outcome|Cycle Exercise With the Active Comparator|
10938948|NCT00754546|OG002|Outcome|Treadmill Exercise With the Placebo Comparator|
10938949|NCT00754546|OG003|Outcome|Cycle Exercise With the Placebo Comparator|
11176740|NCT02037984|BG003|Baseline|Infant V114: 2x:1x:2x|Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
10938950|NCT00754546|EG000|Reported Event|Treadmill Exercise With the Active Comparator|
10938951|NCT00754546|EG001|Reported Event|Cycle Exercise With the Active Comparator|
10938952|NCT00754546|EG002|Reported Event|Treadmill Exercise With the Placebo Comparator|
10938953|NCT00754546|EG003|Reported Event|Cycle Exercise With the Placebo Comparator|
10938954|NCT00754559|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
10938955|NCT00754559|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks for a total of 6 infusions.
10938956|NCT00754559|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
10938957|NCT00754559|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
10938958|NCT00754559|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
10938959|NCT00754559|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8mg /kg iv every 4 weeks for a total of 6 infusions.
10938960|NCT00754559|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
10938961|NCT00754572|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
10938962|NCT00754572|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (iv), once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throuhgout the study.
10938963|NCT00754572|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
10938964|NCT00754572|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
11176741|NCT02037984|BG004|Baseline|Infant V114: 2x:2x:2x|Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
10938965|NCT00754624|BG000|Baseline|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
10938966|NCT00754624|FG000|Participant Flow|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
10938967|NCT00754624|OG000|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
10938968|NCT00754624|EG000|Reported Event|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
10938969|NCT00754650|BG000|Baseline|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
10938970|NCT00754650|FG000|Participant Flow|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
10938971|NCT00754650|OG000|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
10938972|NCT00754650|EG000|Reported Event|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
10938973|NCT00754741|BG000|Baseline|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
10938974|NCT00754741|BG001|Baseline|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
10938975|NCT00754741|BG002|Baseline|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
10938976|NCT00754741|BG003|Baseline|Total|Total of all reporting groups
10938977|NCT00754741|FG000|Participant Flow|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
10938978|NCT00754741|FG001|Participant Flow|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
10938979|NCT00754741|FG002|Participant Flow|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
10938980|NCT00754741|OG000|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
10938981|NCT00754741|OG001|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
10938982|NCT00754741|OG002|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
10938983|NCT00754741|EG000|Reported Event|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
10938984|NCT00754741|EG001|Reported Event|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
10938985|NCT00754741|EG002|Reported Event|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
10938986|NCT00754832|BG000|Baseline|Intent to Treat Study Population|all participants who received at least one dose of either placebo or ginseng in this crossover trial
10938987|NCT00754832|FG000|Participant Flow|Ginseng First Then Placebo|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks followed by 2 weeks washout, then placebo 1 cap daily escalating to 4 caps daily for 6 weeks
10938988|NCT00754832|FG001|Participant Flow|Placebo First Then Ginseng|placebo 1 cap daily escalating to 4 caps daily for 6 weeks followed by 2 weeks washout, then ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
11176742|NCT02037984|BG005|Baseline|Infant V114: 0.5x:0.5x:2x|Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
10938989|NCT00754832|OG000|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
10938990|NCT00754832|OG001|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
10938991|NCT00754832|EG000|Reported Event|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
10938992|NCT00754832|EG001|Reported Event|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
10938993|NCT00754845|BG000|Baseline|Letrozole|"Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~letrozole: Given orally"
10938994|NCT00754845|BG001|Baseline|Placebo|"Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~placebo: Given orally"
10938995|NCT00754845|BG002|Baseline|Total|Total of all reporting groups
10938996|NCT00754845|FG000|Participant Flow|Letrozole|"Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~letrozole: Given orally"
10938997|NCT00754845|FG001|Participant Flow|Placebo|"Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~placebo: Given orally"
10938998|NCT00754845|OG000|Outcome|Letrozole|"Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~letrozole: Given orally"
10938999|NCT00754845|OG001|Outcome|Placebo|"Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~placebo: Given orally"
10939000|NCT00754845|OG000|Outcome|Arm I|"Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~letrozole: Given orally"
10939001|NCT00754845|OG001|Outcome|Arm II|"Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~placebo: Given orally"
10939002|NCT00754845|EG000|Reported Event|Arm I|"Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~letrozole: Given orally"
10939003|NCT00754845|EG001|Reported Event|Arm II|"Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.~placebo: Given orally"
10939004|NCT00754923|BG000|Baseline|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
10939005|NCT00754923|FG000|Participant Flow|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
10939006|NCT00754923|OG000|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
11176743|NCT02037984|BG006|Baseline|Infant V114: 1x:1x:2x|Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176744|NCT02037984|BG007|Baseline|Infant Prevnar 13®|Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
10939007|NCT00754923|EG000|Reported Event|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
10939008|NCT00754936|BG000|Baseline|Escitalopram|"12 week open label with 2 week placebo period (14 weeks total)~Escitalopram: 20 mg by mouth daily"
10939009|NCT00754936|FG000|Participant Flow|Escitalopram|"12 week open label with 2 week placebo period (14 weeks total)~Escitalopram: 20 mg by mouth daily"
10939010|NCT00754936|OG000|Outcome|Escitalopram|"12 week open label with 2 week placebo period (14 weeks total)~Escitalopram: 20 mg by mouth daily"
10939011|NCT00754936|EG000|Reported Event|Escitalopram|"12 week open label with 2 week placebo period (14 weeks total)~Escitalopram: 20 mg by mouth daily"
10939012|NCT00755040|BG000|Baseline|Ocular Cyclosporine (Restasis)|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
10939013|NCT00755040|BG001|Baseline|Placebo|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
10939014|NCT00755040|BG002|Baseline|Total|Total of all reporting groups
10939015|NCT00755040|FG000|Participant Flow|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
10939016|NCT00755040|FG001|Participant Flow|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
10939017|NCT00755040|OG000|Outcome|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
10939018|NCT00755040|OG001|Outcome|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
10939019|NCT00755040|EG000|Reported Event|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
10939020|NCT00755040|EG001|Reported Event|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
10939021|NCT00755079|BG000|Baseline|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
10939022|NCT00755079|BG001|Baseline|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
10939023|NCT00755079|BG002|Baseline|Total|Total of all reporting groups
10939024|NCT00755079|FG000|Participant Flow|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
10939025|NCT00755079|FG001|Participant Flow|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
10939026|NCT00755079|OG000|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
10939027|NCT00755079|OG001|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
10939028|NCT00755079|EG000|Reported Event|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
10939029|NCT00755079|EG001|Reported Event|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
10939030|NCT00755105|BG000|Baseline|Male Subjects Having Consumed Iron-55 Tracer|
10939031|NCT00755105|BG001|Baseline|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
10939032|NCT00755105|BG002|Baseline|Postmenopausal Women Having Consumed Iron-55 Tracer|
10939033|NCT00755105|BG003|Baseline|Total|Total of all reporting groups
10939034|NCT00755105|FG000|Participant Flow|Male Subjects Having Consumed Iron-55 Tracer|
10939035|NCT00755105|FG001|Participant Flow|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
10939036|NCT00755105|FG002|Participant Flow|Postmenopausal Women Having Consumed Iron-55 Tracer|
10939037|NCT00755105|OG000|Outcome|Male Subjects Having Consumed Iron-55 Tracer|
10939038|NCT00755105|OG001|Outcome|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
10939039|NCT00755105|OG002|Outcome|Postmenopausal Women Having Consumed Iron-55 Tracer|
10939040|NCT00755105|EG000|Reported Event|Male Subjects Having Consumed Iron-55 Tracer|
10939041|NCT00755105|EG001|Reported Event|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
10939042|NCT00755105|EG002|Reported Event|Postmenopausal Women Having Consumed Iron-55 Tracer|
10939043|NCT00755131|BG000|Baseline|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
10939044|NCT00755131|BG001|Baseline|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
10939045|NCT00755131|BG002|Baseline|Total|Total of all reporting groups
10939046|NCT00755131|FG000|Participant Flow|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
11176745|NCT02037984|BG008|Baseline|Total|Total of all reporting groups
10939047|NCT00755131|FG001|Participant Flow|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
10939048|NCT00755131|OG000|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
10939049|NCT00755131|OG001|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
10939050|NCT00755131|EG000|Reported Event|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
10939051|NCT00755131|EG001|Reported Event|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
10939052|NCT00755183|BG000|Baseline|Testosterone Ophthalmic Solution|"testosterone ophthalmic solution 0.03%~Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days."
10939053|NCT00755183|BG001|Baseline|Vehicle|"vehicle of testosterone ophthalmic solution~Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days."
10939054|NCT00755183|BG002|Baseline|Total|Total of all reporting groups
10939055|NCT00755183|FG000|Participant Flow|Testosterone Ophthalmic Solution|"testosterone ophthalmic solution 0.03%~Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days."
10939056|NCT00755183|FG001|Participant Flow|Vehicle|"vehicle of testosterone ophthalmic solution~Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days."
10939057|NCT00755183|OG000|Outcome|Testosterone Ophthalmic Solution|"testosterone ophthalmic solution 0.03%~testosterone ophthalmic solution: testosterone ophthalmic solution for 128 days"
10939058|NCT00755183|OG001|Outcome|Vehicle|"vehicle of testosterone ophthalmic solution~vehicle of testosterone ophthalmic solution: vehicle of testosterone ophthalmic solution for 128 days"
11176746|NCT02037984|FG000|Participant Flow|Adult V114: 1x:1x:1x|On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant [APA]).
11176747|NCT02037984|FG001|Participant Flow|Adult V114: 2x.2x.2x|On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
11176748|NCT02037984|FG002|Participant Flow|Infant V114: 1x:1x:1x|Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
10939059|NCT00755183|OG000|Outcome|Testosterone Ophthalmic Solution|"testosterone ophthalmic solution 0.03%~Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days."
10939060|NCT00755183|OG001|Outcome|Vehicle|"vehicle of testosterone ophthalmic solution~Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days."
10939061|NCT00755183|EG000|Reported Event|Testosterone Ophthalmic Solution|"testosterone ophthalmic solution 0.03%~Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days."
10939062|NCT00755183|EG001|Reported Event|Vehicle|"vehicle of testosterone ophthalmic solution~Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days."
10939063|NCT00755196|BG000|Baseline|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939064|NCT00755196|FG000|Participant Flow|AN2728 5 Percent (%) Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939065|NCT00755196|OG000|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939066|NCT00755196|OG000|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment- targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939067|NCT00755196|EG000|Reported Event|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939068|NCT00755222|BG000|Baseline|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
10939069|NCT00755222|BG001|Baseline|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
10939070|NCT00755222|BG002|Baseline|Total|Total of all reporting groups
10939071|NCT00755222|FG000|Participant Flow|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
10939072|NCT00755222|FG001|Participant Flow|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
10939073|NCT00755222|OG000|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
10939074|NCT00755222|OG001|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
10939075|NCT00755222|EG000|Reported Event|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
10939076|NCT00755222|EG001|Reported Event|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
10939077|NCT00755235|BG000|Baseline|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
10939078|NCT00755235|BG001|Baseline|Usual Care|Participants will receive their usual care, with no additional education or care management services.
10939079|NCT00755235|BG002|Baseline|Total|Total of all reporting groups
10939080|NCT00755235|FG000|Participant Flow|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
10939081|NCT00755235|FG001|Participant Flow|Usual Care|Participants will receive their usual care, with no additional education or care management services.
10939082|NCT00755235|OG000|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
10939083|NCT00755235|OG001|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
10939084|NCT00755235|EG000|Reported Event|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
11176749|NCT02037984|FG003|Participant Flow|Infant V114: 2x:1x:2x|Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176750|NCT02037984|FG004|Participant Flow|Infant V114: 2x:2x:2x|Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176751|NCT02037984|FG005|Participant Flow|Infant V114: 0.5x:0.5x:2x|Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176752|NCT02037984|FG006|Participant Flow|Infant V114: 1x:1x:2x|Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176753|NCT02037984|FG007|Participant Flow|Infant Prevnar 13®|Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176754|NCT02037984|OG000|Outcome|Adult V114: 1x:1x:1x|On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
11176755|NCT02037984|OG001|Outcome|Adult V114: 2x.2x.2x|On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
11176756|NCT02037984|OG000|Outcome|Infant V114: 1x:1x:1x|Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176757|NCT02037984|OG001|Outcome|Infant V114: 2x:1x:2x|Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176758|NCT02037984|OG002|Outcome|Infant V114: 2x:2x:2x|Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176759|NCT02037984|OG003|Outcome|Infant V114: 0.5x:0.5x:2x|Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176760|NCT02037984|OG004|Outcome|Infant V114: 1x:1x:2x|Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176761|NCT02037984|OG005|Outcome|Infant Prevnar 13®|Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176762|NCT02037984|OG001|Outcome|Infant Prevnar 13®|Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176763|NCT02037984|OG000|Outcome|Infant V114: 2x:1x:2x|Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 μg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176764|NCT02037984|OG000|Outcome|Infant V114: 2x:2x:2x|Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 μg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176765|NCT02037984|OG000|Outcome|Infant V114: 0.5x:0.5x:2x|Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 μg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176766|NCT02037984|OG000|Outcome|Infant V114: 1x:1x:2x|Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 μg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176767|NCT02037984|OG001|Outcome|Infant Prevnar 13®|Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age
11176768|NCT02037984|OG000|Outcome|All Infant Participants|Infant participants in the V114 treatment arms are included.
11176769|NCT02037984|OG000|Outcome|Infant V114: 0.5x:0.5x:2x|Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176770|NCT02037984|OG003|Outcome|Infant V114: 1x:1x:2x|Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176771|NCT02037984|OG000|Outcome|All V114 Infant Participants|All infant participants in the V114 treatment arms are included.
10939085|NCT00755235|EG001|Reported Event|Usual Care|Participants will receive their usual care, with no additional education or care management services.
10939086|NCT00755274|BG000|Baseline|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
10939087|NCT00755274|BG001|Baseline|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
10939088|NCT00755274|BG002|Baseline|Total|Total of all reporting groups
10939089|NCT00755274|FG000|Participant Flow|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
10939090|NCT00755274|FG001|Participant Flow|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
11176772|NCT02037984|EG000|Reported Event|Adult: V114-1x:1x:1x|On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA).
11176773|NCT02037984|EG001|Reported Event|Adult: V114-2x:2x:2x|On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA).
10939091|NCT00755274|OG000|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
10939092|NCT00755274|OG001|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
10939093|NCT00755274|EG000|Reported Event|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
10939094|NCT00755274|EG001|Reported Event|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
10939095|NCT00755326|BG000|Baseline|HLXL|"Active herb~HLXL: Two daily dosages will be investigated. The lowest dosage condition will be 10 capsules (4000 mg) daily for the first two weeks to evaluate safety, followed by an escalation to the 14 capsule condition (5,600 mg). Participants will be treated for 8 weeks."
11176774|NCT02037984|EG002|Reported Event|Infant: V114-1x:1x:1x|Infants receive 4 total V114: 1x:1x:1x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176775|NCT02037984|EG003|Reported Event|Infant: V114-2x:1x:2x|Infants receive 4 total V114: 2x:1x:2x (containing 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176776|NCT02037984|EG004|Reported Event|Infant: V114-2x:2x:2x|Infants receive 4 total V114: 2x:2x:2x (containing 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
10939096|NCT00755326|BG001|Baseline|Placebo|"Placebo~Placebo: Subjects in the placebo group received an equal number of placebo capsule."
10939097|NCT00755326|BG002|Baseline|Total|Total of all reporting groups
10939098|NCT00755326|FG000|Participant Flow|HLXL|"Active herb~HLXL: Three daily dosages will be investigated. The lowest dosage condition will be 6 capsules (2,400 mg) daily, followed by an escalation to the 10 capsule condition (4,000 mg), and then to the 14 capsule (5,600 mg) condition. Participants will be treated for 6 weeks"
10939099|NCT00755326|FG001|Participant Flow|Placebo|"Placebo~The placebo was made from a list of FDA approved ingredients/excipient that matched the color and taste of the real HLXL herbal extract, instead of just white powder used in other placebo trials. Same size and color of capsules were used for the placebo and herbal extract. The equivalent number of capsules used in the treatment group at each dose level were administered to patients assigned to the control group."
10939100|NCT00755326|OG000|Outcome|HLXL|"Active herb~HLXL: Two daily dosages will be investigated. The subjects in the HLXL group received the medium dose of HLXL (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/day) for the subsequent 6 weeks."
10939101|NCT00755326|OG001|Outcome|Placebo|"Placebo HLXL~Placebo: Subjects in the placebo group received an equal number of placebo capsule."
10939102|NCT00755326|OG001|Outcome|Placebo|"Placebo HLXL~HLXL: Subjects in the placebo group received an equal number of placebo capsule."
10939103|NCT00755326|EG000|Reported Event|HLXL|"Active herb~HLXL: Two daily dosages will be investigated. The subjects in the HLXL group received the medium dose of HLXL (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/ day) for the subsequent 6 weeks."
10939104|NCT00755326|EG001|Reported Event|Placebo|"Placebo HLXL~Subjects in the placebo group received an equal number of placebo capsule."
10939105|NCT00755417|BG000|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
10939106|NCT00755417|BG001|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
10939107|NCT00755417|BG002|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
10939108|NCT00755417|BG003|Baseline|Total|Total of all reporting groups
10939109|NCT00755417|FG000|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
10939110|NCT00755417|FG001|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
10939111|NCT00755417|FG002|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
10939112|NCT00755417|OG000|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
10939113|NCT00755417|OG001|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
10939114|NCT00755417|OG002|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
10939115|NCT00755417|EG000|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
10939116|NCT00755417|EG001|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
10939117|NCT00755417|EG002|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
10939118|NCT00755716|BG000|Baseline|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill): patients receive"
10939119|NCT00755716|BG001|Baseline|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
10939120|NCT00755716|BG002|Baseline|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
10939121|NCT00755716|BG003|Baseline|Total|Total of all reporting groups
10939122|NCT00755716|FG000|Participant Flow|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill):"
10939123|NCT00755716|FG001|Participant Flow|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
10939124|NCT00755716|FG002|Participant Flow|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
10939125|NCT00755716|OG000|Outcome|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill): patients receive"
10939126|NCT00755716|OG001|Outcome|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
10939127|NCT00755716|OG002|Outcome|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
10939128|NCT00755716|EG000|Reported Event|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill): patients receive"
10939129|NCT00755716|EG001|Reported Event|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
10939130|NCT00755716|EG002|Reported Event|Topiramate & Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
10939131|NCT00755755|BG000|Baseline|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939132|NCT00755755|BG001|Baseline|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939133|NCT00755755|BG002|Baseline|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939134|NCT00755755|BG003|Baseline|Total|Total of all reporting groups
10939135|NCT00755755|FG000|Participant Flow|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939136|NCT00755755|FG001|Participant Flow|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939137|NCT00755755|FG002|Participant Flow|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939138|NCT00755755|OG000|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939139|NCT00755755|OG001|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939140|NCT00755755|OG002|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939141|NCT00755755|EG000|Reported Event|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939142|NCT00755755|EG001|Reported Event|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939143|NCT00755755|EG002|Reported Event|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
10939144|NCT00755807|BG000|Baseline|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
10939145|NCT00755807|BG001|Baseline|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
10939146|NCT00755807|BG002|Baseline|Total|Total of all reporting groups
10939147|NCT00755807|FG000|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
10939148|NCT00755807|FG001|Participant Flow|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
10939149|NCT00755807|OG000|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
10939150|NCT00755807|OG001|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
10939151|NCT00755807|OG001|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
10939152|NCT00755807|OG000|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
10939153|NCT00755807|OG000|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
10939154|NCT00755807|EG000|Reported Event|Duloxetine - Double-Blind Acute Phase|60 mg oral (po), once daily (QD) for 6 weeks (acute phase)
10939155|NCT00755807|EG001|Reported Event|Placebo - Double-Blind Acute Phase|Oral, QD for 6 weeks
10939156|NCT00755807|EG002|Reported Event|Duloxetine - Open-label Extension Phase|Participants previously receiving duloxetine or placebo in the double-blind acute phase received duloxetine 60, 90, or 120 mg QD for 12 weeks (open label extension phase)
10939157|NCT00755846|BG000|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
10939158|NCT00755846|BG001|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
10939159|NCT00755846|BG002|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
10939160|NCT00755846|BG003|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
10939161|NCT00755846|BG004|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
10939162|NCT00755846|BG005|Baseline|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
10939163|NCT00755846|BG006|Baseline|Total|Total of all reporting groups
10939164|NCT00755846|FG000|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
10939165|NCT00755846|FG001|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
10939166|NCT00755846|FG002|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
10939167|NCT00755846|FG003|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
10939168|NCT00755846|FG004|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
10939169|NCT00755846|FG005|Participant Flow|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
10939170|NCT00755846|OG000|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
10939171|NCT00755846|OG001|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
10939172|NCT00755846|OG002|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
10939173|NCT00755846|OG003|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
10939174|NCT00755846|OG004|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
10939175|NCT00755846|OG005|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
10939176|NCT00755846|EG000|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
10939177|NCT00755846|EG001|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
10939178|NCT00755846|EG002|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
10939179|NCT00755846|EG003|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
10939180|NCT00755846|EG004|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
10939181|NCT00755846|EG005|Reported Event|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
10939182|NCT00755911|BG000|Baseline|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
10939183|NCT00755911|BG001|Baseline|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
10939184|NCT00755911|BG002|Baseline|Total|Total of all reporting groups
10939185|NCT00755911|FG000|Participant Flow|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
10939186|NCT00755911|FG001|Participant Flow|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
10939187|NCT00755911|OG000|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
10939188|NCT00755911|OG001|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
10939189|NCT00755911|EG000|Reported Event|Experimental: Tissue Repair Cell (TRC)|Subjects will receive TRC therapy plus Gelfoam carrier
10939190|NCT00755911|EG001|Reported Event|Sham Comparator: Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
10939191|NCT00755937|BG000|Baseline|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
10939192|NCT00755937|FG000|Participant Flow|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
10939193|NCT00755937|OG000|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
10939194|NCT00755937|EG000|Reported Event|Subjects Receiving Remicade|
10939195|NCT00756002|BG000|Baseline|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
10939196|NCT00756002|BG001|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
10939197|NCT00756002|BG002|Baseline|Total|Total of all reporting groups
10939198|NCT00756002|FG000|Participant Flow|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
10939199|NCT00756002|FG001|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
11341650|NCT03686033|FG004|Participant Flow|Sequence 5: E2082 2.5 mg + Placebo + E2082 25 mg + E2082 40 mg|Participants received, E2082 2.5 mg (Treatment B) tablet, orally, once on Day 1 in Treatment Period 1, followed by E2082-matched placebo (Treatment A) tablet, orally, once on Day 1 in Treatment Period 2, followed by E2082 25 mg (Treatment C) tablet, orally, once on Day 1 in Treatment Period 3, followed by E2082 40 mg tablet, orally, once on Day 1 in Treatment Period 4 (Open-label). A washout phase of at least 2 weeks was maintained between the treatment periods.
10939200|NCT00756002|OG000|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
10939201|NCT00756002|OG001|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
10939202|NCT00756002|EG000|Reported Event|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
10939203|NCT00756002|EG001|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
10939204|NCT00756093|BG000|Baseline|Overall Study|
10939205|NCT00756093|FG000|Participant Flow|Systane, Then Optive, Then Blink Tears, Then GenTeal Moderate|Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last.
10939206|NCT00756093|FG001|Participant Flow|Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane|Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane
10939207|NCT00756093|FG002|Participant Flow|Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive|Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last
10939208|NCT00756093|FG003|Participant Flow|GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears|Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last
10939209|NCT00756093|OG000|Outcome|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
10939210|NCT00756093|OG001|Outcome|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
10939211|NCT00756093|OG002|Outcome|Blink Tears|Blink Tears
10939212|NCT00756093|OG003|Outcome|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
10939213|NCT00756093|EG000|Reported Event|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
10939214|NCT00756093|EG001|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
10939215|NCT00756093|EG002|Reported Event|Blink Tears|Blink Tears
10939216|NCT00756093|EG003|Reported Event|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
10939217|NCT00756106|BG000|Baseline|Temozolomide and Radiation Therapy|"temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.~Imaging biomarker analysis: MRI~Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions."
10939218|NCT00756106|FG000|Participant Flow|Temozolomide and Radiation Therapy|"temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.~Imaging biomarker analysis: MRI~Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions."
10939219|NCT00756106|OG000|Outcome|Temozolomide and Radiation Therapy|"temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.~Imaging biomarker analysis: MRI~Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions."
10939220|NCT00756106|EG000|Reported Event|Temozolomide and Radiation Therapy|"temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.~Imaging biomarker analysis: MRI~Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions."
10939221|NCT00756236|BG000|Baseline|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.~Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
10939222|NCT00756236|BG001|Baseline|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.~Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
10939223|NCT00756236|BG002|Baseline|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.~P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
10939224|NCT00756236|BG003|Baseline|Total|Total of all reporting groups
10939225|NCT00756236|FG000|Participant Flow|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.~Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
10939226|NCT00756236|FG001|Participant Flow|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.~Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
10939227|NCT00756236|FG002|Participant Flow|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.~P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
10939228|NCT00756236|OG000|Outcome|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.~Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
10939229|NCT00756236|OG001|Outcome|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.~Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
10939230|NCT00756236|OG002|Outcome|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.~P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
10939231|NCT00756236|EG000|Reported Event|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.~Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
10939232|NCT00756236|EG001|Reported Event|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.~Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
10939233|NCT00756236|EG002|Reported Event|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.~P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
10939234|NCT00756275|BG000|Baseline|Nicotine Replacement + PLA Pill|"Nicotine Replacement Treatment (NRT): Nicotine replacement treatment (NRT) will follow the clinical practice guidelines for nicotine patch for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use (tapering recommended for people with AUDs by Hughes et al., 2003b): 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3"
10939235|NCT00756275|BG001|Baseline|Varenicline + PLA Patch|"varenicline: Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day.~Pl"
10939236|NCT00756275|BG002|Baseline|Total|Total of all reporting groups
10939237|NCT00756275|FG000|Participant Flow|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use: 21mg/day for 4 weeks, 14mg/day for 4 weeks, 7mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
11176777|NCT02037984|EG005|Reported Event|Infant: V114-0.5x:0.5x:2x|Infants receive 4 total V114 0.5x:0.5x:2x (containing 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176778|NCT02037984|EG006|Reported Event|Infant: V114-1x:1x:2x|Infants receive 4 total V114 1x:1x:2x (containing 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA) total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
10939238|NCT00756275|FG001|Participant Flow|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~varenicline: Varenicline (VAR, 2mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
10939239|NCT00756275|OG000|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
11176779|NCT02037984|EG007|Reported Event|Infant: Prevnar 13|Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age.
11176780|NCT02038010|BG000|Baseline|BYL719 and T-DM1 Treatment|"Patients receive either 250 mg (Cohort -1) or 300 mg (Cohort 1) PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176781|NCT02038010|FG000|Participant Flow|Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)|"Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176782|NCT02038010|FG001|Participant Flow|Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)|"Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176783|NCT02038010|FG002|Participant Flow|Cohort 2 (350mg BYL719, 3.6mg/kg T-DM1)|"Patients receive 350 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176784|NCT02038010|FG003|Participant Flow|Cohort 3 (400mg BYL719, 3.6mg/kg T-DM1)|"Patients receive 400 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176785|NCT02038010|OG000|Outcome|Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)|"Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176786|NCT02038010|OG001|Outcome|Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)|"Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176787|NCT02038010|OG000|Outcome|250mg or 300mg BYL719, 3.6mg/kg T-DM1|"Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 in Cohort -1 and 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 in Cohort 1~All patients also received 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176788|NCT02038010|OG000|Outcome|BYL719 and T-DM1 Treatment|"Patients receive either 250 mg (Cohort -1) or 300 mg (Cohort 1) PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176789|NCT02038010|EG000|Reported Event|Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)|"Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
10939240|NCT00756275|OG001|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
10939241|NCT00756275|EG000|Reported Event|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
10939242|NCT00756275|EG001|Reported Event|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
10939243|NCT00756314|BG000|Baseline|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
10939244|NCT00756314|BG001|Baseline|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
10939245|NCT00756314|BG002|Baseline|Total|Total of all reporting groups
10939246|NCT00756314|FG000|Participant Flow|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
10939247|NCT00756314|FG001|Participant Flow|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
10939248|NCT00756314|OG000|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
10939249|NCT00756314|OG001|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
10939250|NCT00756314|EG000|Reported Event|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
10939251|NCT00756314|EG001|Reported Event|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
10939252|NCT00756444|BG000|Baseline|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
10939253|NCT00756444|BG001|Baseline|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
10939254|NCT00756444|BG002|Baseline|Total|Total of all reporting groups
10939255|NCT00756444|FG000|Participant Flow|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
10939256|NCT00756444|FG001|Participant Flow|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
11192146|NCT02137486|OG000|Outcome|Sequential Ballooning|the stent is placed in the MV and dilated, and then a second balloon just proximal to the opening of the SB is dilated in order to widen the diameter of the MV at the SV opening to allow more blood to be diverted into the SB; then treated with drug eluting stent or bare metal stent.
10939257|NCT00756444|OG000|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
10939258|NCT00756444|OG001|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
10939259|NCT00756444|EG000|Reported Event|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
10939260|NCT00756444|EG001|Reported Event|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
10939261|NCT00756444|EG002|Reported Event|Total|
10939262|NCT00756457|BG000|Baseline|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
10939263|NCT00756457|BG001|Baseline|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
10939264|NCT00756457|BG002|Baseline|Total|Total of all reporting groups
10939265|NCT00756457|FG000|Participant Flow|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
10939266|NCT00756457|FG001|Participant Flow|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
10939267|NCT00756457|OG000|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
10939268|NCT00756457|OG001|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
10939269|NCT00756457|OG002|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
10939270|NCT00756457|OG003|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
10939271|NCT00756457|OG004|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
10939272|NCT00756457|OG005|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
11192147|NCT02137486|OG001|Outcome|Final Kissing Ballooning|a balloon that extends from a position in the MV just proximal to the SB into a portion of the SB is inflated at the same time as the MV balloon; then treated with drug eluting stent or bare metal stent.
10939273|NCT00756457|OG000|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
10939274|NCT00756457|OG001|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
10939275|NCT00756457|OG002|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
10939276|NCT00756457|OG003|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
10939277|NCT00756457|OG004|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
10939278|NCT00756457|OG005|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
10939279|NCT00756457|OG001|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
10939280|NCT00756457|OG003|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
10939281|NCT00756457|OG005|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
10939282|NCT00756457|OG000|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
10939283|NCT00756457|OG002|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
10939284|NCT00756457|OG004|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
10939285|NCT00756457|EG000|Reported Event|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
11176790|NCT02038010|EG001|Reported Event|Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)|"Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor BYL719: Given PO~Ado-trastuzumab emtansine: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Optional correlative studies"
11176791|NCT02038023|BG000|Baseline|Intravenous Iron|As oral iron intolerant iron deficient 2nd and 3rd trimester gravidas defined by a ferritin of <20 ng/mL and TSAT ,19%. All were anemic by ACOG criteria of Hb <10.5 g/dL in 2nd trimester or, 11g/dL in 3rd, who received 1000 mg IV low molecular weight iron dextran in one hour
11176792|NCT02038023|FG000|Participant Flow|IV Iron|"Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron.~Intravaneous iron(low molecular weight iron dextran): 1000 mg of Iron dextran administered over one hour"
11176793|NCT02038023|OG000|Outcome|Iron Deficient Gravidas|This has been described twice before. Iron deficient pregnant women in the 2nd and 3rd trimester
11176794|NCT02038023|OG000|Outcome|Intravenous Iron|As oral iron intolerant iron deficient 2nd and 3rd trimester gravidas defined by a ferritin of <20 ng/mL and TSAT, 19%. All were anemic by ACOG criteria of Hb <10.5 g/dL in 2nd trimester or, 11g/dL in 3rd, who received 1000 mg IV low molecular weight iron dextran in one hour
11176795|NCT02038023|OG000|Outcome|Only One Group[|Post treatment hemoglobin in 73/74 gravidas
11176796|NCT02038023|EG000|Reported Event|IV Iron|"Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron.~Intravaneous iron(low molecular weight iron dextran): 1000 mg of Iron dextran administered over one hour"
11176797|NCT02038036|BG000|Baseline|Ruxolitinib|Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
11176798|NCT02038036|BG001|Baseline|Best Available Therapy (BAT)|Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
11176799|NCT02038036|BG002|Baseline|Total|Total of all reporting groups
11176800|NCT02038036|FG000|Participant Flow|Ruxolitinib|Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
11176801|NCT02038036|FG001|Participant Flow|Best Available Therapy (BAT)|Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
11176802|NCT02038036|OG000|Outcome|Ruxolitinib|Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
11176803|NCT02038036|OG001|Outcome|Best Available Therapy (BAT)|Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
11176804|NCT02038036|OG000|Outcome|All Crossover Patients|Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib
11176805|NCT02038036|OG000|Outcome|Best Available Therapy (BAT)|Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib
11176806|NCT02038036|EG000|Reported Event|Ruxolitinib|Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
11176807|NCT02038036|EG001|Reported Event|Best Available Therapy|Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
11176808|NCT02038036|EG002|Reported Event|All Crossover Patients|Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib
11176809|NCT02038049|BG000|Baseline|VAY736|Intravenous infusion of VAY736
11176810|NCT02038049|BG001|Baseline|Placebo to VAY736|Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
11176811|NCT02038049|BG002|Baseline|Total|Total of all reporting groups
11176812|NCT02038049|FG000|Participant Flow|VAY736|Intravenous infusion of VAY736
11176813|NCT02038049|FG001|Participant Flow|Placebo to VAY736|Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
11176814|NCT02038049|OG000|Outcome|VAY736|Intravenous infusion of VAY736
11176815|NCT02038049|OG001|Outcome|Placebo to VAY736|Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
11176816|NCT02038049|OG000|Outcome|VAY736 Administered at Visit 2 (Day 1)|Intravenous infusion of VAY736 at Visit 2 (Day 1)
11176817|NCT02038049|OG001|Outcome|VAY736 Administered at Visit 7 (Week 16 - Week 17)|Intravenous infusion of VAY736 at Visit 7 (Week 16 - Week 17)
11176818|NCT02038049|OG002|Outcome|Placebo Administered at Visit 2|Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
11176819|NCT02038049|EG000|Reported Event|VAY736 Administered at Visit 2 (Day 1)|Intravenous infusion of VAY736 at Visit 2 (Day 1)
11176820|NCT02038049|EG001|Reported Event|VAY736 Administered at Visit 7 (Week 16 - Week 17)|Intravenous infusion of VAY736 at Visit 7 (Week 16 - Week 17)
11176821|NCT02038049|EG002|Reported Event|Placebo Administered at Visit 2|Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
11192148|NCT02137486|OG000|Outcome|Sequential Ballooning|include BMS or DES
11192149|NCT02137486|OG001|Outcome|Final Kissing Ballooning|include BMS or DES
11192150|NCT02137486|EG000|Reported Event|Sequential Ballooning|treated with drug eluting stent or bare metal stent.
10939286|NCT00756457|EG001|Reported Event|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
10939287|NCT00756470|BG000|Baseline|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
10939288|NCT00756470|FG000|Participant Flow|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil (5FU), Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
10939289|NCT00756470|OG000|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
10939290|NCT00756470|EG000|Reported Event|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
10939291|NCT00756496|BG000|Baseline|FFDM Mammography Examination|Screening or diagnostic mammography exam.
10939292|NCT00756496|FG000|Participant Flow|Mammography Exam|Full Field Digital Mammography exam
10939293|NCT00756496|OG000|Outcome|FFDM Mammography Exam - LIP Algorithm|Screening or diagnostic Full Field Digital Mammography (FFDM) exam
10939294|NCT00756496|OG001|Outcome|FFDM Mammography Exam - SIP Algorithm|The same 130 raw data images were externally reprocessed with the Siemens processing algorithm.
10939295|NCT00756496|EG000|Reported Event|Mammography Exam|FFDM screening or diagnostic mammography exam
10939296|NCT00756548|BG000|Baseline|BLI850|
10939297|NCT00756548|BG001|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
10939298|NCT00756548|BG002|Baseline|Total|Total of all reporting groups
10939299|NCT00756548|FG000|Participant Flow|BLI850|single administration oral preparation - split dose
10939300|NCT00756548|FG001|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|single administration oral preparation - split dose
10939301|NCT00756548|OG000|Outcome|BLI850|
10939302|NCT00756548|OG001|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
10939303|NCT00756548|OG000|Outcome|BLI850|multi-dose preparation for oral administration
10939304|NCT00756548|OG001|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
10939305|NCT00756548|EG000|Reported Event|BLI850|
10939306|NCT00756548|EG001|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
10939307|NCT00756561|BG000|Baseline|Healthy Normal Males|Men, 18-50 years of age, in good health
10939308|NCT00756561|FG000|Participant Flow|Healthy Normal Males|Men, 18-50 years of age, in good health
10939309|NCT00756561|OG000|Outcome|Intratesticular Concentration|Average intratesticular hormone concentration between right and left testis in 10 normal men
10939310|NCT00756561|OG001|Outcome|Serum Concentration|Serum hormone concentration in 10 normal men
10939311|NCT00756561|EG000|Reported Event|Healthy Normal Males|Men, 18-50 years of age, in good health
10939312|NCT00756600|BG000|Baseline|Regional Anesthesia|Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
10939313|NCT00756600|BG001|Baseline|General Anesthesia|General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
10939314|NCT00756600|BG002|Baseline|Total|Total of all reporting groups
10939315|NCT00756600|FG000|Participant Flow|Regional Anesthesia|Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
10939316|NCT00756600|FG001|Participant Flow|General Anesthesia|General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
10939317|NCT00756600|OG000|Outcome|Regional Anesthesia|Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
10939318|NCT00756600|OG001|Outcome|General Anesthesia|General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
10939319|NCT00756600|OG000|Outcome|Regional Anesthesia1|Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
11234233|NCT02433080|BG000|Baseline|Shape-Up Following Cancer Treatment|"In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called Shape-Up following cancer treatment: a self-help programme on eating well and being active. Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group.~Shape-Up following cancer treatment: The programme is based on Social Cognitive Theory and Control Theory. The focus of the programme lies on self-control, self-efficacy, and relapse prevention."
11234234|NCT02433080|BG001|Baseline|Control Intervention|"Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.~During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet Healthy living after cancer; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards."
11234235|NCT02433080|BG002|Baseline|Total|Total of all reporting groups
11234236|NCT02433080|FG000|Participant Flow|Shape-Up Following Cancer Treatment|"In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called Shape-Up following cancer treatment: a self-help programme on eating well and being active. Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group.~Shape-Up following cancer treatment: The programme is based on Social Cognitive Theory and Control Theory. The focus of the programme lies on self-control, self-efficacy, and relapse prevention."
11234237|NCT02433080|FG001|Participant Flow|Control Intervention|"Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.~During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet Healthy living after cancer; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards."
11234238|NCT02433080|OG000|Outcome|Both Arms Combined|Recruitment to the trial overall
10939320|NCT00756600|EG000|Reported Event|Regional Anesthesia|Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
10939321|NCT00756600|EG001|Reported Event|General Anesthesia|General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
11234239|NCT02433080|OG000|Outcome|Shape-Up Following Cancer Treatment|"In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called Shape-Up following cancer treatment: a self-help programme on eating well and being active. Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group.~Shape-Up following cancer treatment: The programme is based on Social Cognitive Theory and Control Theory. The focus of the programme lies on self-control, self-efficacy, and relapse prevention."
11234240|NCT02433080|OG001|Outcome|Control Intervention|"Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.~During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet Healthy living after cancer; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards."
10939322|NCT00756613|BG000|Baseline|465 VADT Participants - Standard|The participants had previously participated in the VADT CSP #465 study
10939323|NCT00756613|BG001|Baseline|465 VADT Participants -Intensive|The participants had previously participated in the VADT CSP #465 study
10939324|NCT00756613|BG002|Baseline|Total|Total of all reporting groups
10939325|NCT00756613|FG000|Participant Flow|465 VADT Participants - Standard|The participants had previously participated in the VADT trial in the standard of care group.
10939326|NCT00756613|FG001|Participant Flow|465 VADT Participants - Intensive|The participants had previously participated in the VADT CSP #465 study in the intensive treatment group.
10939327|NCT00756613|OG000|Outcome|465 VADT Participants - Standard|The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
11234241|NCT02433080|EG000|Reported Event|Shape-Up Following Cancer Treatment|"In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called Shape-Up following cancer treatment: a self-help programme on eating well and being active. Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group.~Shape-Up following cancer treatment: The programme is based on Social Cognitive Theory and Control Theory. The focus of the programme lies on self-control, self-efficacy, and relapse prevention."
11234242|NCT02433080|EG001|Reported Event|Control Intervention|"Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.~During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet Healthy living after cancer; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards."
11234243|NCT02433288|BG000|Baseline|Active Group|receive the smart phone-based patient support tool
11234244|NCT02433288|BG001|Baseline|Control Group|provided only the control application and not the smart phone-based patient support tool
10939328|NCT00756613|OG001|Outcome|465 VADT Participants -Intensive|The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
10939329|NCT00756613|OG000|Outcome|465 VADT Participants - Standard|The participants had only participated in the VADT Cooperative Studies Program Follow-up #465-F study in standard treatment group.
10939330|NCT00756613|OG001|Outcome|465 VADT Participants -Intensive|The participants had only participated in the VADT Cooperative Studies Program Follow-up #465-F study in the intensive group.
11234245|NCT02433288|BG002|Baseline|Total|Total of all reporting groups
11234246|NCT02433288|FG000|Participant Flow|Active Group|receive the smart phone-based patient support tool
11234247|NCT02433288|FG001|Participant Flow|Control Group|provided only the control application and not the smart phone-based patient support tool
11234248|NCT02433288|OG000|Outcome|Active Group|receive the smart phone-based patient support tool
11234249|NCT02433288|OG001|Outcome|Control Group|provided only the control application and not the smart phone-based patient support tool
11234250|NCT02433288|EG000|Reported Event|Active Group|receive the smart phone-based patient support tool
11234251|NCT02433288|EG001|Reported Event|Control Group|provided only the control application and not the smart phone-based patient support tool
11234252|NCT02433340|BG000|Baseline|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234253|NCT02433340|BG001|Baseline|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234254|NCT02433340|BG002|Baseline|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234255|NCT02433340|BG003|Baseline|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
10939331|NCT00756613|EG000|Reported Event||serious and other [non-serious] adverse events were not collected or assessed as part of the study
10939332|NCT00756652|BG000|Baseline|Original Phase - MemoryGel Participants|Subjects implanted with MemoryGel breast implants
10939333|NCT00756652|BG001|Baseline|Original Phase - Saline Breast Implant Control Participants|Subjects implanted with saline filled breast implants
10939334|NCT00756652|BG002|Baseline|Total|Total of all reporting groups
10939335|NCT00756652|FG000|Participant Flow|MemoryGel Breast Implant Participants|Subjects who received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery
11234256|NCT02433340|BG004|Baseline|Total|Total of all reporting groups
11234257|NCT02433340|FG000|Participant Flow|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind Adalimumab (ADA) 40 mg every other week (EOW) for 11 weeks. Open-label ABT-122 120 mg EOW.
11234258|NCT02433340|FG001|Participant Flow|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234259|NCT02433340|FG002|Participant Flow|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234260|NCT02433340|FG003|Participant Flow|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
10939336|NCT00756652|FG001|Participant Flow|Saline Breast Implant Control Participants|Subjects who received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery
10939337|NCT00756652|OG000|Outcome|MemoryGel Participants|Subjects who received MemoryGel breast implants
10939338|NCT00756652|EG000|Reported Event|Overall Study|Subjects in either the MemoryGel group or the saline breast implant control group
10939339|NCT00756678|BG000|Baseline|All Patients|All patients
10939340|NCT00756678|FG000|Participant Flow|All Patients|All patients
10939341|NCT00756678|OG000|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
10939342|NCT00756678|OG001|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
10939343|NCT00756678|EG000|Reported Event|All Patients|All patients
10939344|NCT00756717|BG000|Baseline|MK-0752|"Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days~MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days."
10939345|NCT00756717|FG000|Participant Flow|MK-0752|"Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days~MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days."
10939346|NCT00756717|OG000|Outcome|MK-0752|"Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days~MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days."
10939347|NCT00756717|EG000|Reported Event|MK-0752|"Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days~MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days."
10939348|NCT00756730|BG000|Baseline|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
10939349|NCT00756730|BG001|Baseline|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
10939350|NCT00756730|BG002|Baseline|Total|Total of all reporting groups
10939351|NCT00756730|FG000|Participant Flow|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
10939352|NCT00756730|FG001|Participant Flow|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
10939353|NCT00756730|OG000|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
10939354|NCT00756730|OG001|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
10939355|NCT00756730|EG000|Reported Event|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
10939356|NCT00756730|EG001|Reported Event|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
10939357|NCT00756886|BG000|Baseline|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
10939358|NCT00756886|BG001|Baseline|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
10939359|NCT00756886|BG002|Baseline|Total|Total of all reporting groups
10939360|NCT00756886|FG000|Participant Flow|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
10939361|NCT00756886|FG001|Participant Flow|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
10939362|NCT00756886|OG000|Outcome|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
10939363|NCT00756886|OG001|Outcome|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
10939364|NCT00756886|EG000|Reported Event|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
10939365|NCT00756886|EG001|Reported Event|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
10939366|NCT00756964|BG000|Baseline|Rasburicase Group|The drug rasburicase was used in this group.
10939367|NCT00756964|BG001|Baseline|Placebo Group|This group received an identical placebo of rasburicase.
10939368|NCT00756964|BG002|Baseline|Total|Total of all reporting groups
10939369|NCT00756964|FG000|Participant Flow|Rasburicase Group|The drug rasburicase was used in this group.
10939370|NCT00756964|FG001|Participant Flow|Placebo Group|This group received an identical placebo of rasburicase.
10939371|NCT00756964|OG000|Outcome|Rasburicase Group|The patients received the drug rasburicase 7.5mg in 50mL of normal saline over 30 minutes period
10939372|NCT00756964|OG001|Outcome|Placebo Group|The patients which received a placebo identical to rasburicase.
10939373|NCT00756964|EG000|Reported Event|Rasburicase Group|The drug rasburicase was used in this group.
10939374|NCT00756964|EG001|Reported Event|Placebo Group|This group received an identical placebo of rasburicase.
10939375|NCT00756977|BG000|Baseline|BLI850|
10939376|NCT00756977|BG001|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
10939377|NCT00756977|BG002|Baseline|Total|Total of all reporting groups
10939378|NCT00756977|FG000|Participant Flow|BLI850|Single administration oral preparation
10939379|NCT00756977|FG001|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Single administration oral preparation
10939380|NCT00756977|OG000|Outcome|BLI850|
10939381|NCT00756977|OG001|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
10939382|NCT00756977|EG000|Reported Event|BLI850|
10939383|NCT00756977|EG001|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
10939384|NCT00757003|BG000|Baseline|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
10939385|NCT00757003|FG000|Participant Flow|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
10939386|NCT00757003|OG000|Outcome|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
10939387|NCT00757003|OG000|Outcome|Treatment Arm - Placement of TAG Device|"A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta~Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta"
10939388|NCT00757003|EG000|Reported Event|Treatment Arm - Placement of TAG Device|"A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta~Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta"
10939389|NCT00757172|BG000|Baseline|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
10939390|NCT00757172|FG000|Participant Flow|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
10939391|NCT00757172|OG000|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
10939392|NCT00757172|EG000|Reported Event|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
10939393|NCT00757237|BG000|Baseline|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
10939394|NCT00757237|BG001|Baseline|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
10939395|NCT00757237|BG002|Baseline|Total|Total of all reporting groups
10939396|NCT00757237|FG000|Participant Flow|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
10939397|NCT00757237|FG001|Participant Flow|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
10939398|NCT00757237|OG000|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
10939399|NCT00757237|OG001|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
10939400|NCT00757237|EG000|Reported Event|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
10939401|NCT00757237|EG001|Reported Event|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
10939402|NCT00757484|BG000|Baseline|Women Who Underwent Gyneologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
10939403|NCT00757484|FG000|Participant Flow|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
10939404|NCT00757484|OG000|Outcome|Women Who Underwent Scheduled Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
10939405|NCT00757484|OG000|Outcome|Women Who Underwent GYN Surgery|All women who underwent inpatient GYN surgery between Jan 2007 and 2008.
10939406|NCT00757484|OG000|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
10939407|NCT00757484|EG000|Reported Event|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient gynecologic surgery between Jan 2007 and 2008.
10939408|NCT00757588|BG000|Baseline|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
10939409|NCT00757588|BG001|Baseline|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
10939410|NCT00757588|BG002|Baseline|Total|Total of all reporting groups
10939411|NCT00757588|FG000|Participant Flow|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
10939412|NCT00757588|FG001|Participant Flow|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
10939413|NCT00757588|OG000|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
10939414|NCT00757588|OG001|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
10939415|NCT00757588|EG000|Reported Event|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
10939416|NCT00757588|EG001|Reported Event|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
10939417|NCT00757601|BG000|Baseline|All Participants|Participants were treated with MK1006 or dose-matched placebo over 5 treatment periods.
10939418|NCT00757601|FG000|Participant Flow|15mg MK1006/Placebo/45mg MK1006/60mg MK1006/Placebo (Fed)|Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
10939419|NCT00757601|FG001|Participant Flow|Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)|Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
10939420|NCT00757601|FG002|Participant Flow|15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
10939421|NCT00757601|FG003|Participant Flow|15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
10939422|NCT00757601|FG004|Participant Flow|60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo|Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
10939423|NCT00757601|FG005|Participant Flow|Placebo/80mg MK1006/100mg MK1006/120mg MK1006/140mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
10939424|NCT00757601|FG006|Participant Flow|60mg MK1006/80mg MK1006/Placebo/120mg MK1006/140mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
10939425|NCT00757601|FG007|Participant Flow|60 mg MK1006/80 mg MK1006/100 mg MK1006/Placebo/140 mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
10939426|NCT00757601|FG008|Participant Flow|140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo|Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5
10939427|NCT00757601|FG009|Participant Flow|Placebo/170mg MK1006/200mg MK1006/230mg MK1006/260mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
10939428|NCT00757601|FG010|Participant Flow|140mg MK1006/170mg MK1006/Placebo/230mg MK1006/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
10939429|NCT00757601|FG011|Participant Flow|140mg MK1006/170mg MK1006/200mg MK1006/Placebo/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
10939430|NCT00757601|OG000|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
10939431|NCT00757601|OG001|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
10939432|NCT00757601|OG002|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
10939433|NCT00757601|OG003|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
10939434|NCT00757601|OG004|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
10939435|NCT00757601|OG005|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
10939436|NCT00757601|OG006|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
10939437|NCT00757601|OG007|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
10939438|NCT00757601|OG008|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
11192151|NCT02137486|EG001|Reported Event|Final Kissing Ballooning|treated with drug eluting stent or bare metal stent.
10939439|NCT00757601|OG009|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
10939440|NCT00757601|OG010|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
10939441|NCT00757601|OG011|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
10939442|NCT00757601|OG012|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
10939443|NCT00757601|OG013|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
10939444|NCT00757601|EG000|Reported Event|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
10939445|NCT00757601|EG001|Reported Event|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
10939446|NCT00757601|EG002|Reported Event|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
10939447|NCT00757601|EG003|Reported Event|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
10939448|NCT00757601|EG004|Reported Event|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
10939449|NCT00757601|EG005|Reported Event|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
10939450|NCT00757601|EG006|Reported Event|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
10939451|NCT00757601|EG007|Reported Event|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
10939452|NCT00757601|EG008|Reported Event|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
10939453|NCT00757601|EG009|Reported Event|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
10939454|NCT00757601|EG010|Reported Event|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
10939455|NCT00757601|EG011|Reported Event|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
10939456|NCT00757601|EG012|Reported Event|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
10939457|NCT00757601|EG013|Reported Event|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
10939458|NCT00757666|BG000|Baseline|Accelerometer|Accelerometer
10939459|NCT00757666|BG001|Baseline|Minute Ventilation|Minute ventilation
10939460|NCT00757666|BG002|Baseline|Total|Total of all reporting groups
10939461|NCT00757666|FG000|Participant Flow|Accelerometer|Accelerometer
10939462|NCT00757666|FG001|Participant Flow|Minute Ventilation|Minute ventilation
10939463|NCT00757666|OG000|Outcome|Minute Ventilation|
10939464|NCT00757666|OG001|Outcome|Accelerometer|
10939465|NCT00757666|OG000|Outcome|Accelerometer|"Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.~Rate adaptive pacemaker: Accelerometer sensor"
10939466|NCT00757666|OG001|Outcome|Minute Ventilation|"Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.~Rate adaptive pacemaker: Minute ventilation sensor"
10939467|NCT00757666|OG000|Outcome|Accelerometer|Accelerometer
10939468|NCT00757666|OG001|Outcome|Minute Ventilation|Minute ventilation
10939469|NCT00757666|EG000|Reported Event|Accelerometer|Accelerometer
10939470|NCT00757666|EG001|Reported Event|Minute Ventilation|Minute ventilation
10939471|NCT00757705|BG000|Baseline|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug.
10939472|NCT00757705|FG000|Participant Flow|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug.
10939473|NCT00757705|OG000|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug.
10939474|NCT00757705|EG000|Reported Event|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug.
10939475|NCT00757783|BG000|Baseline|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
10939476|NCT00757783|BG001|Baseline|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
10939477|NCT00757783|BG002|Baseline|Total|Total of all reporting groups
10939478|NCT00757783|FG000|Participant Flow|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
10939479|NCT00757783|FG001|Participant Flow|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
11192152|NCT02137499|BG000|Baseline|Healthy Subjects|Healthy participants treated with Small transcutaneous electrical stimulator
10939480|NCT00757783|OG000|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
11176822|NCT02038075|BG000|Baseline|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
11176823|NCT02038075|BG001|Baseline|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
11176824|NCT02038075|BG002|Baseline|Total|Total of all reporting groups
11176825|NCT02038075|FG000|Participant Flow|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
11176826|NCT02038075|FG001|Participant Flow|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
11176827|NCT02038075|OG000|Outcome|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
11176828|NCT02038075|OG001|Outcome|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
11176829|NCT02038075|EG000|Reported Event|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
11176830|NCT02038075|EG001|Reported Event|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
11176831|NCT02038179|BG000|Baseline|Overall|"Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.~Placebo: The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks."
11176832|NCT02038179|FG000|Participant Flow|Allopurinol Then Placebo|"Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.~The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol (300 mg per day PO) or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol (300 mg per day PO) or placebo for an additional 4 weeks."
11192153|NCT02137499|BG001|Baseline|Superficial Venous Insufficiency|Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator
11192154|NCT02137499|BG002|Baseline|Deep Venous Insufficiency|Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator
10939481|NCT00757783|OG001|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
10939482|NCT00757783|EG000|Reported Event|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
10939483|NCT00757783|EG001|Reported Event|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
11176833|NCT02038179|FG001|Participant Flow|Placebo Then Allopurinol|"Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.~The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol (300 mg per day PO) or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol (300 mg per day PO) or placebo for an additional 4 weeks."
11176834|NCT02038179|OG000|Outcome|Allopurinol Phase|Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received 300 mg, per day (PO) of allopurinol for approximately four weeks.
10939484|NCT00757822|BG000|Baseline|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
10939485|NCT00757822|BG001|Baseline|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
10939486|NCT00757822|BG002|Baseline|Total|Total of all reporting groups
10939487|NCT00757822|FG000|Participant Flow|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 30-60 min prior start of surgery."
10939488|NCT00757822|FG001|Participant Flow|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4 mg) will be administered iv 20-30 min prior to end of surgery in those patients not receiving Dronabinol."
10939489|NCT00757822|OG000|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
10939490|NCT00757822|OG001|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
11176835|NCT02038179|OG001|Outcome|Placebo Phase|Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received placebo, daily (PO) for approximately four weeks.
11176836|NCT02038179|EG000|Reported Event|Allopurinol|"Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.~The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth."
11176837|NCT02038179|EG001|Reported Event|Placebo|"Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.~The subjects will be randomized to receive placebo once daily by mouth."
10939491|NCT00757822|OG000|Outcome|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
10939492|NCT00757822|OG001|Outcome|Arm 2: Ondnasetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
10939493|NCT00757822|OG001|Outcome|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
10939494|NCT00757822|EG000|Reported Event|Dronabinol- Experimental Therapy|Dronabinol (5mg) was administered po 30-60 min prior to start of elective abdominal surgery scheduled for same day discharge to home.
10939495|NCT00757822|EG001|Reported Event|Ondansetron-control Therapy|Ondansetron (4 mg) was administered iv 20-30 min prior to end of elective abdominal surgery scheduled for same day discharge to home.
10939496|NCT00757848|BG000|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
10939497|NCT00757848|BG001|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
10939498|NCT00757848|BG002|Baseline|Total|Total of all reporting groups
10939499|NCT00757848|FG000|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
10939500|NCT00757848|FG001|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
10939501|NCT00757848|OG000|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
10939502|NCT00757848|OG001|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
10939503|NCT00757848|EG000|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
10939504|NCT00757848|EG001|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
10939505|NCT00758043|BG000|Baseline|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
10939506|NCT00758043|BG001|Baseline|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
10939507|NCT00758043|BG002|Baseline|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
10939508|NCT00758043|BG003|Baseline|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
10939509|NCT00758043|BG004|Baseline|Total|Total of all reporting groups
10939510|NCT00758043|FG000|Participant Flow|T12PR24 (eRVR+)|Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
10939511|NCT00758043|FG001|Participant Flow|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
11176838|NCT02038218|BG000|Baseline|ARM 1|"Arm-1: Patients with without liver involvement or history of liver disease, will be treated at a dose of 98.7 mg/m2.~Patients will be treated every once every 21 days with a single infusion of DM-CHOC-PEN as an out-patient.~4-Demethyl-4-cholestryloxycarbonylpenclomedine: This will be an open-label, uncontrolled two-arm, multi-center study in patients with CNS involvement from melanoma, breast, lung cancers or primary malignancies of the CNS."
11176839|NCT02038218|BG001|Baseline|ARM 2|"Arm-2: Patients with liver involvement or history of liver disease, will be treated at a dose of 85.8mg/m2.~Patients will be treated every once every 21 days with a single infusion of DM-CHOC-PEN as an out-patient.~4-Demethyl-4-cholestryloxycarbonylpenclomedine: This will be an open-label, uncontrolled two-arm, multi-center study in patients with CNS involvement from melanoma, breast, lung cancers or primary malignancies of the CNS."
11176840|NCT02038218|BG002|Baseline|Total|Total of all reporting groups
11176841|NCT02038218|FG000|Participant Flow|DM-CHOC-PEN - Arm 1|"Cohort 1: Patients without liver involvement or history of liver disease, will be treated at a dose of 98.7 mg/m2.~Patients in both Arms 1 & 2 will discontinue dosing with DM-CHOC-PEN when there are any unacceptable toxicities, progression of cancer or patient compliance.~4-Demethyl-4-cholestryloxycarbonylpenclomedine: This will be an open-label, uncontrolled two-arm, multi-center study in patients with CNS involvement from melanoma, breast, lung cancers or primary malignancies of the CNS. Patients can be previously treated with radiation and systemic therapies and are eligible if they also have other sites of cancer involvement.~Two Cohorts of patients will be treated every 21 days with a single infusion of"
11176842|NCT02038218|FG001|Participant Flow|DM-CHOC-PEN - Arm 2|Cohort 2: Patients with liver involvement or history of disease will be treated at a dose of 85.8 mg/m2; 5 patients were in this group
11176843|NCT02038218|OG000|Outcome|DM-CHOC-PEN - Arm 1|"Cohort 1: Patients without liver involvement or history of liver disease, will be treated at a dose of 98.7 mg/m2.~Patients will discontinue dosing with DM-CHOC-PEN when there are any unacceptable toxicities, progression of cancer or patient compliance.~4-Demethyl-4-cholestryloxycarbonylpenclomedine: This will be an open-label, uncontrolled two-arm, multi-center study in patients with CNS involvement from melanoma, breast, lung cancers or primary malignancies of the CNS. Patients can be previously treated with radiation and systemic therapies and are eligible if they also have other sites of cancer involvement."
11176844|NCT02038218|OG001|Outcome|DM-CHOC-PEN - Arm 2|"Cohort 2: Patients with liver involvement or history of disease will be treated at a dose of 85.8 mg/m2.~Patients will discontinue dosing with DM-CHOC-PEN when there are any unacceptable toxicities, progression of cancer or patient compliance.~4-Demethyl-4-cholestryloxycarbonylpenclomedine: This will be an open-label, uncontrolled multi-center study in patients with CNS involvement from melanoma, breast, lung cancers or primary malignancies of the CNS. Patients can be previously treated with radiation and systemic therapies and are eligible if they also have other sites of cancer involvement."
11176845|NCT02038218|EG000|Reported Event|ARM 1|Patients without liver involvement
11176846|NCT02038218|EG001|Reported Event|ARM 2|Patients with liver involvement
11176847|NCT02038543|BG000|Baseline|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
11176848|NCT02038543|BG001|Baseline|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
11176849|NCT02038543|BG002|Baseline|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
11176850|NCT02038543|BG003|Baseline|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified a PH types 1, 2, or 3.
11176851|NCT02038543|BG004|Baseline|Total|Total of all reporting groups
11176852|NCT02038543|FG000|Participant Flow|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
11176853|NCT02038543|FG001|Participant Flow|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
11176854|NCT02038543|FG002|Participant Flow|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
11176855|NCT02038543|FG003|Participant Flow|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as primary hyperoxaluria (PH) types 1, 2, or 3.
11176856|NCT02038543|OG000|Outcome|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
11176857|NCT02038543|OG001|Outcome|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
11176858|NCT02038543|OG002|Outcome|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
11176859|NCT02038543|OG003|Outcome|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as PH types 1, 2, or 3.
11176860|NCT02038543|EG000|Reported Event|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
11176861|NCT02038543|EG001|Reported Event|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
11176862|NCT02038543|EG002|Reported Event|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
11192155|NCT02137499|BG003|Baseline|Deep Venous Obstruction|Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
10939512|NCT00758043|FG002|Participant Flow|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
10939513|NCT00758043|FG003|Participant Flow|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
10939514|NCT00758043|OG000|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
10939515|NCT00758043|OG001|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
10939516|NCT00758043|OG002|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
11234261|NCT02433340|OG000|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234262|NCT02433340|OG001|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234263|NCT02433340|OG002|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234264|NCT02433340|OG003|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
11234265|NCT02433340|OG004|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
10939517|NCT00758043|OG003|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
10939518|NCT00758043|OG000|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
10939519|NCT00758043|OG001|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
10939520|NCT00758043|OG002|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
10939521|NCT00758043|OG003|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
10939522|NCT00758043|OG000|Outcome|T12PR24 (eRVR+)|Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
10939523|NCT00758043|OG003|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen
10939524|NCT00758043|EG000|Reported Event|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
10939525|NCT00758043|EG001|Reported Event|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
10939526|NCT00758043|EG002|Reported Event|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
11234266|NCT02433340|EG000|Reported Event|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234267|NCT02433340|EG001|Reported Event|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234268|NCT02433340|EG002|Reported Event|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
11234269|NCT02433340|EG003|Reported Event|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
11234270|NCT02433340|EG004|Reported Event|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
11234271|NCT02433366|BG000|Baseline|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
11234272|NCT02433366|BG001|Baseline|Patients|AF patients on treatment with Pradaxa®.
11234273|NCT02433366|BG002|Baseline|Total|Total of all reporting groups
11234274|NCT02433366|FG000|Participant Flow|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
11234275|NCT02433366|FG001|Participant Flow|Patients|AF patients on treatment with Pradaxa®.
11234276|NCT02433366|OG000|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
11234277|NCT02433366|OG001|Outcome|Patients|AF patients on treatment with Pradaxa®.
11234278|NCT02433366|EG000|Reported Event|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
11234279|NCT02433366|EG001|Reported Event|Patients|AF patients on treatment with Pradaxa®.
11234280|NCT02433379|BG000|Baseline|UNTOUCHED Implanted/Attempted Subjects|"UNTOUCHED Study subjects who were implanted or attempted for implant with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.~EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp."
10939527|NCT00758043|EG003|Reported Event|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
10939528|NCT00758069|BG000|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
10939529|NCT00758069|BG001|Baseline|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
10939530|NCT00758069|BG002|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
10939531|NCT00758069|BG003|Baseline|Total|Total of all reporting groups
10939532|NCT00758069|FG000|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
10939533|NCT00758069|FG001|Participant Flow|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
10939534|NCT00758069|FG002|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
10939535|NCT00758069|OG000|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
10939536|NCT00758069|OG001|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
10939537|NCT00758069|OG002|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
10939538|NCT00758069|EG000|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
10939539|NCT00758069|EG001|Reported Event|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
10939540|NCT00758069|EG002|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
10939541|NCT00758160|BG000|Baseline|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
10939542|NCT00758160|FG000|Participant Flow|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
10939543|NCT00758160|OG000|Outcome|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
10939544|NCT00758160|OG000|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
10939545|NCT00758160|EG000|Reported Event|OROS MPH-Baseline|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
10939546|NCT00758160|EG001|Reported Event|OROS MPH-Week 2|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
10939547|NCT00758160|EG002|Reported Event|OROS MPH-Week 4|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
11176863|NCT02038543|EG003|Reported Event|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified a PH types 1, 2, or 3.
11176864|NCT02038569|BG000|Baseline|LEO 80185 Gel|LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.
11176865|NCT02038569|FG000|Participant Flow|LEO 80185 Gel|LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
11176866|NCT02038569|OG000|Outcome|LEO 80185 Gel|LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
11176867|NCT02038569|OG000|Outcome|LEO 80185 Gel|LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.
11176868|NCT02038569|EG000|Reported Event|LEO 80185 Gel|LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.
11176869|NCT02038647|BG000|Baseline|Alisertib + Paclitaxel|Alisertib 40 mg, tablets, orally, twice a day, 3 days on/4 days off for 3 weeks on Days 1-3, 8-10, and 15-17 in a 28-day cycle along with paclitaxel 60 mg/m^2 intravenously (IV) once a week for 3 weeks on Days 1, 8, and 15 in a 28-day cycle until disease progression (Up to 17 Cycles).
11192156|NCT02137499|BG004|Baseline|Total|Total of all reporting groups
11192157|NCT02137499|FG000|Participant Flow|Healthy Subjects|Healthy participants treated with Small transcutaneous electrical stimulator
11176870|NCT02038647|BG001|Baseline|Placebo + Paclitaxel|Alisertib placebo-matching tablets, orally, twice a day, 3 days on/4 days off for 3 weeks on Days 1-3, 8-10, and 15-17 in a 28-day cycle along with paclitaxel 80 mg/m^2 IV once a week for 3 weeks on Days 1, 8, and 15 in a 28-day cycle until disease progression (Up to 22 Cycles).
11176871|NCT02038647|BG002|Baseline|Total|Total of all reporting groups
11176872|NCT02038647|FG000|Participant Flow|Alisertib + Paclitaxel|Alisertib 40 mg, tablets, orally, twice a day, 3 days on/4 days off for 3 weeks on Days 1-3, 8-10, and 15-17 in a 28-day cycle along with paclitaxel 60 mg/m^2 intravenously (IV) once a week for 3 weeks on Days 1, 8, and 15 in a 28-day cycle until disease progression (Up to 17 Cycles).
11176873|NCT02038647|FG001|Participant Flow|Placebo + Paclitaxel|Alisertib placebo-matching tablets, orally, twice a day, 3 days on/4 days off for 3 weeks on Days 1-3, 8-10, and 15-17 in a 28-day cycle along with paclitaxel 80 mg/m^2 IV once a week for 3 weeks on Days 1, 8, and 15 in a 28-day cycle until disease progression (Up to 22 Cycles).
11176874|NCT02038647|OG000|Outcome|Alisertib + Paclitaxel|Alisertib 40 mg, tablets, orally, twice a day, 3 days on/4 days off for 3 weeks on Days 1-3, 8-10, and 15-17 in a 28-day cycle along with paclitaxel 60 mg/m^2 intravenously (IV) once a week for 3 weeks on Days 1, 8, and 15 in a 28-day cycle until disease progression (Up to 17 Cycles).
11176875|NCT02038647|OG001|Outcome|Placebo + Paclitaxel|Alisertib placebo-matching tablets, orally, twice a day, 3 days on/4 days off for 3 weeks on Days 1-3, 8-10, and 15-17 in a 28-day cycle along with paclitaxel 80 mg/m^2 IV once a week for 3 weeks on Days 1, 8, and 15 in a 28-day cycle until disease progression (Up to 22 Cycles).
11176876|NCT02038647|EG000|Reported Event|Alisertib + Paclitaxel|Alisertib 40 mg, tablets, orally, twice a day, 3 days on/4 days off for 3 weeks on Days 1-3, 8-10, and 15-17 in a 28-day cycle along with paclitaxel 60 mg/m^2 intravenously (IV) once a week for 3 weeks on Days 1, 8, and 15 in a 28-day cycle until disease progression (Up to 17 Cycles).
11176877|NCT02038647|EG001|Reported Event|Placebo + Paclitaxel|Alisertib placebo-matching tablets, orally, twice a day, 3 days on/4 days off for 3 weeks on Days 1-3, 8-10, and 15-17 in a 28-day cycle along with paclitaxel 80 mg/m^2 IV once a week for 3 weeks on Days 1, 8, and 15 in a 28-day cycle until disease progression (Up to 22 Cycles).
11176878|NCT02038764|BG000|Baseline|Placebo|Participants were randomly assigned to placebo in a 2/8 ratio in Cohorts 1 through 3 and a 1/4 ratio in Cohort 4. The treatment was given as a subcutaneous injection(s)
11176879|NCT02038764|BG001|Baseline|PF-06342674 1 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176880|NCT02038764|BG002|Baseline|PF-06342674 3 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176881|NCT02038764|BG003|Baseline|PF-06342674 6 mg/kg|Participants received their dose as a subcutaneous injection(s) once a week (q1w) up to 12 doses.
11176882|NCT02038764|BG004|Baseline|PF-06342674 8 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176883|NCT02038764|BG005|Baseline|Total|Total of all reporting groups
11176884|NCT02038764|FG000|Participant Flow|Placebo|Participants were randomly assigned to placebo in a 2/8 ratio in Cohorts 1 through 3 and a 1/4 ratio in Cohort 4. The treatment was given as a subcutaneous injection(s)
11176885|NCT02038764|FG001|Participant Flow|PF-06342674 1 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176886|NCT02038764|FG002|Participant Flow|PF-06342674 3 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176887|NCT02038764|FG003|Participant Flow|PF-06342674 6 mg/kg|Participants received their dose as a subcutaneous injection(s) once a week (q1w) up to 12 doses.
11176888|NCT02038764|FG004|Participant Flow|PF-06342674 8 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176889|NCT02038764|OG000|Outcome|Placebo|Participants were randomly assigned to placebo in a 2/8 ratio in Cohorts 1 through 3 and a 1/4 ratio in Cohort 4. The treatment was given as a subcutaneous injection(s)
11176890|NCT02038764|OG001|Outcome|Cohort 1 PF-06342674 1 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176891|NCT02038764|OG002|Outcome|Cohort 2 PF-06342674 3 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176892|NCT02038764|OG003|Outcome|Cohort 4 PF-06342674 6 mg/kg|Participants received their dose as a subcutaneous injection(s) once a week (q1w) up to 12 doses.
11176893|NCT02038764|OG004|Outcome|Cohort 3 PF-06342674 8 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176894|NCT02038764|OG000|Outcome|Cohort 1 PF-06342674 1 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176895|NCT02038764|OG001|Outcome|Cohort 2 PF-06342674 3 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176896|NCT02038764|OG002|Outcome|Cohort 4 PF-06342674 6 mg/kg|Participants received their dose as a subcutaneous injection(s) once a week (q1w) up to 12 doses.
11176897|NCT02038764|OG003|Outcome|Cohort 3 PF-06342674 8 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176898|NCT02038764|EG000|Reported Event|Placebo|Participants were randomly assigned to placebo in a 2/8 ratio in Cohorts 1 through 3 and a 1/4 ratio in Cohort 4. The treatment was given as a subcutaneous injection(s)
11176899|NCT02038764|EG001|Reported Event|PF-06342674 1 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
10939548|NCT00758160|EG003|Reported Event|OROS MPH-Week 8|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
10939549|NCT00758264|BG000|Baseline|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939550|NCT00758264|BG001|Baseline|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939551|NCT00758264|BG002|Baseline|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939552|NCT00758264|BG003|Baseline|Total|Total of all reporting groups
11176900|NCT02038764|EG002|Reported Event|PF-06342674 3 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176901|NCT02038764|EG003|Reported Event|PF-06342674 6 mg/kg|Participants received their dose as a subcutaneous injection(s) once a week (q1w) up to 12 doses.
11176902|NCT02038764|EG004|Reported Event|PF-06342674 8 mg/kg|Participants received their dose as a subcutaneous injection(s) once every two weeks (q2w) up to 6 doses.
11176903|NCT02038790|BG000|Baseline|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
11176904|NCT02038790|FG000|Participant Flow|Suboxone - Zubsolv|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1.
11176905|NCT02038790|FG001|Participant Flow|Zubsolv - Suboxone|Participants received Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 0 and Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 1.
11176906|NCT02038790|OG000|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
11176907|NCT02038790|OG000|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
11176908|NCT02038790|OG001|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
11176909|NCT02038790|EG000|Reported Event|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
11176910|NCT02038790|EG001|Reported Event|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
11176911|NCT02038829|BG000|Baseline|Total|Total of all participants
11176912|NCT02038829|FG000|Participant Flow|Treatment Group 1|Participants received SUN-101 50mcg; Aclidinium 400mcg; Placebo; SUN-101 6,25mcg; SUN-101 3mcg; SUN-101 12.5mcg
11176913|NCT02038829|FG001|Participant Flow|Treatment Group 2|Participants received Placebo; SUN-101 50mcg; SUN-101 3mcg Aclidinium 400mcg; SUN-101 12.5 mcg; SUN-101 6mcg
11176914|NCT02038829|FG002|Participant Flow|Treatment Group 3|Participants received SUN-101 3mcg Placebo; SUN-101 12.5 mcg; SUN-101 50mcg; SUN-101 6.25mcg Aclidinium 400mcg;
11176915|NCT02038829|FG003|Participant Flow|Treatment Group 4|Participants received SUN-101 12.5 mcg; SUN-101 3mcg Placebo; SUN-101 50mcg; Aclidinium 400mcg; SUN-101 6.25mcg
11176916|NCT02038829|FG004|Participant Flow|Treatment Group 5|"Participants received SUN-101 6.25mcg SUN-101 12.5 mcg; Aclidinium 400mcg; SUN-101 3mcg SUN-101 50mcg Placebo;~Aclidinium 400mcg; SUN-101 6.25mcg"
11176917|NCT02038829|FG005|Participant Flow|Treatment Group 6|"Participants received Aclidinium 400mcg; SUN-101 6.25mcg SUN-101 50mcg SUN-101 12.5 mcg; Placebo; SUN-101 3mcg~Placebo;"
11176918|NCT02038829|FG006|Participant Flow|Treatment Group 7|"Participants received SUN-101 3mcg SUN-101 50mcg Aclidinium 400mcg; Placebo; SUN-101 6.25mcg SUN-101 12.5 mcg;~SUN-101 3mcg"
11176919|NCT02038829|FG007|Participant Flow|Treatment Group 8|Participants received Aclidinium 400mcg; SUN-101 3mcg SUN-101 6.25mcg SUN-101 50mcg SUN-101 12.5 mcg; Placebo;
11176920|NCT02038829|FG008|Participant Flow|Treatment Group 9|Participants received SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 12.5 mcg SUN-101 3mcg Placebo; SUN-101 50mcg
10939553|NCT00758264|FG000|Participant Flow|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939554|NCT00758264|FG001|Participant Flow|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939555|NCT00758264|FG002|Participant Flow|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
11176921|NCT02038829|FG009|Participant Flow|Treatment Group 10|Participants received SUN-101 12.5 mcg SUN-101 6.25mcg Placebo; Aclidinium 400mcg; SUN-101 50 mcg SUN-101 3mcg
11176922|NCT02038829|FG010|Participant Flow|Treatment Group 11|Participants received Placebo; SUN-101 12.5 mcg SUN-101 50 mcg SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 3mcg
10939556|NCT00758264|OG000|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939557|NCT00758264|OG001|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939558|NCT00758264|OG002|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939559|NCT00758264|EG000|Reported Event|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939560|NCT00758264|EG001|Reported Event|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939561|NCT00758264|EG002|Reported Event|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
10939562|NCT00758342|BG000|Baseline|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
11176923|NCT02038829|FG011|Participant Flow|Treatment Group 12|Participants received SUN-101 50 mcg Placebo; SUN-101 3mcg SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 12.5 mcg
11176924|NCT02038829|OG000|Outcome|Placebo|"Placebo bid~Placebo: Placebo"
11176925|NCT02038829|OG001|Outcome|SUN-101 3 mcg|"SUN-101 3 mcg bid~SUN101 3 mcg: SUN-101 3 mcg bid"
11176926|NCT02038829|OG002|Outcome|SUN-101 6.25 mcg|"SUN-101 6.25 mcg bid~SUN-101 6.25 mcg: SUN-101 6.25 mcg bid"
11176927|NCT02038829|OG003|Outcome|SUN-101 12.5 mcg|"SUN-101 12.5 mcg bid~SUN-101 12.5 mcg: SUN-101 12.5 mcg bid"
11176928|NCT02038829|OG004|Outcome|SUN-101 50 mcg|"SUN-101 50 mcg bid~SUN-101 50 mcg: SUN-101 50 mcg bid"
11176929|NCT02038829|OG005|Outcome|Aclidinium 400 mcg|"Aclidinium 400 mcg bid~Aclidinium: Aclidinium 400 mcg bid"
11176930|NCT02038829|OG006|Outcome|TOTAL|Total number of study participants
11176931|NCT02038829|EG000|Reported Event|Placebo|"Placebo bid~Placebo: Placebo"
11176932|NCT02038829|EG001|Reported Event|SUN-101 3 mcg|"SUN-101 3 mcg bid~SUN101 3 mcg: SUN-101 3 mcg bid"
11176933|NCT02038829|EG002|Reported Event|SUN-101 6.25 mcg|"SUN-101 6.25 mcg bid~SUN-101 6.25 mcg: SUN-101 6.25 mcg bid"
11176934|NCT02038829|EG003|Reported Event|SUN-101 12.5 mcg|"SUN-101 12.5 mcg bid~SUN-101 12.5 mcg: SUN-101 12.5 mcg bid"
11176935|NCT02038829|EG004|Reported Event|SUN-101 50 mcg|"SUN-101 50 mcg bid~SUN-101 50 mcg: SUN-101 50 mcg bid"
11176936|NCT02038829|EG005|Reported Event|Aclidinium 400 mcg|"Aclidinium 400 mcg bid~Aclidinium: Aclidinium 400 mcg bid"
11176937|NCT02038881|BG000|Baseline|Group 1 (Standard Regimen)|"One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
10939563|NCT00758342|BG001|Baseline|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
10939564|NCT00758342|BG002|Baseline|Total|Total of all reporting groups
10939565|NCT00758342|FG000|Participant Flow|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
10939566|NCT00758342|FG001|Participant Flow|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
10939567|NCT00758342|OG000|Outcome|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
10939568|NCT00758342|OG001|Outcome|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
10939569|NCT00758342|EG000|Reported Event|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
10939570|NCT00758342|EG001|Reported Event|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
11176938|NCT02038881|BG001|Baseline|Group 2 (Double Dose Regimen)|"Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176939|NCT02038881|BG002|Baseline|Group 3 (Booster Regimen)|"One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176940|NCT02038881|BG003|Baseline|Total|Total of all reporting groups
11176941|NCT02038881|FG000|Participant Flow|Group 1 (Standard Regimen)|"One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176942|NCT02038881|FG001|Participant Flow|Group 2 (Double Dose Regimen)|"Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176943|NCT02038881|FG002|Participant Flow|Group 3 (Booster Regimen)|"One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176944|NCT02038881|OG000|Outcome|Group 1 (Standard Regimen)|"One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176945|NCT02038881|OG001|Outcome|Group 2 (Double Dose Regimen)|"Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
10939571|NCT00758394|BG000|Baseline|Fluoride - A|Negative control
10939572|NCT00758394|BG001|Baseline|Fluoride/Triclosan - B|Positive control comparator
11176946|NCT02038881|OG002|Outcome|Group 3 (Booster Regimen)|"One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176947|NCT02038881|OG000|Outcome|Group 1 and 3 Combined|Pooling of Groups 1 and 3 (same dose/regimen before booster vaccination in Group 3)
11176948|NCT02038881|OG001|Outcome|Group 2|Double dose regimen
11176949|NCT02038881|EG000|Reported Event|Group 1 (Standard Regimen)|"One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176950|NCT02038881|EG001|Reported Event|Group 2 (Double Dose Regimen)|"Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11176951|NCT02038881|EG002|Reported Event|Group 3 (Booster Regimen)|"One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)~IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml"
11192158|NCT02137499|FG001|Participant Flow|Superficial Venous Insufficiency|Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator
10939573|NCT00758394|BG002|Baseline|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
10939574|NCT00758394|BG003|Baseline|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
10939575|NCT00758394|BG004|Baseline|Total|Total of all reporting groups
10939576|NCT00758394|FG000|Participant Flow|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
10939577|NCT00758394|FG001|Participant Flow|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
10939578|NCT00758394|FG002|Participant Flow|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
11176952|NCT02038894|BG000|Baseline|Intubated With Sevoflurane (IS)|"Anesthetic technique during (EGD)~Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia."
11176953|NCT02038894|BG001|Baseline|Intubated With Propofol (IP)|"Anesthetic technique during (EGD)~Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia."
11176954|NCT02038894|BG002|Baseline|Native Airway - no Intubation|"Anesthetic technique during (EGD)~Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.~Propofol"
11176955|NCT02038894|BG003|Baseline|Total|Total of all reporting groups
11176956|NCT02038894|FG000|Participant Flow|Intubated With Sevoflurane (IS)|"Anesthetic technique during (EGD)~Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia."
11192159|NCT02137499|FG002|Participant Flow|Deep Venous Insufficiency|Participant with Deep venous insufficiency treated with Small transcutaneous electrical stimulator
11192160|NCT02137499|FG003|Participant Flow|Deep Venous Obstruction|Participant with Deep venous obstruction treated with Small transcutaneous electrical stimulator
10939579|NCT00758394|FG003|Participant Flow|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
10939580|NCT00758394|OG000|Outcome|Fluoride - A|Negative control
10939581|NCT00758394|OG001|Outcome|Fluoride/Triclosan - B|Positive control comparator
10939582|NCT00758394|OG002|Outcome|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
10939583|NCT00758394|OG003|Outcome|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
10939584|NCT00758394|EG000|Reported Event|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
10939585|NCT00758394|EG001|Reported Event|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
10939586|NCT00758394|EG002|Reported Event|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
10939587|NCT00758394|EG003|Reported Event|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
10939588|NCT00758420|BG000|Baseline|Placebo|Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
10939589|NCT00758420|BG001|Baseline|Polidocanol Injectable Foam, 1.0%|Polidocanol injectable foam 1%, up to 15 mL, one treatment session
10939590|NCT00758420|BG002|Baseline|Total|Total of all reporting groups
10939591|NCT00758420|FG000|Participant Flow|Active Treatment|polidocanol injectiable foam 1%, up to 15 mL, one treatment session
10939592|NCT00758420|FG001|Participant Flow|Placebo|"Agitated saline~Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session"
10939593|NCT00758420|OG000|Outcome|Placebo|agitated saline
10939594|NCT00758420|OG001|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
10939595|NCT00758420|EG000|Reported Event|Placebo|agitated saline
10939596|NCT00758420|EG001|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
10939597|NCT00758459|BG000|Baseline|AZD1236|AZD1236
10939598|NCT00758459|BG001|Baseline|Placebo|Placebo
10939599|NCT00758459|BG002|Baseline|Total|Total of all reporting groups
10939600|NCT00758459|FG000|Participant Flow|AZD1236|AZD1236
10939601|NCT00758459|FG001|Participant Flow|Placebo|Placebo
10939602|NCT00758459|OG000|Outcome|AZD1236|AZD1236
10939603|NCT00758459|OG001|Outcome|Placebo|Placebo
10939604|NCT00758459|EG000|Reported Event|AZD1236|AZD1236
10939605|NCT00758459|EG001|Reported Event|Placebo|Placebo
10939606|NCT00758485|BG000|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
10939607|NCT00758485|BG001|Baseline|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
10939608|NCT00758485|BG002|Baseline|Total|Total of all reporting groups
10939609|NCT00758485|FG000|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
10939610|NCT00758485|FG001|Participant Flow|Placebo|Participants receiving Placebo (0.9% sodium chloride[NaCl]) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
10939611|NCT00758485|OG000|Outcome|Sugammadex|Participants receiving 4.0 mg/kg-1 Sugammadex at a target depth of NMB of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
10939612|NCT00758485|OG001|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
10939613|NCT00758485|OG000|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
10939614|NCT00758485|EG000|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
10939615|NCT00758485|EG001|Reported Event|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
10939616|NCT00758498|BG000|Baseline|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939617|NCT00758498|BG001|Baseline|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939618|NCT00758498|BG002|Baseline|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939619|NCT00758498|BG003|Baseline|Total|Total of all reporting groups
10939620|NCT00758498|FG000|Participant Flow|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939621|NCT00758498|FG001|Participant Flow|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939622|NCT00758498|FG002|Participant Flow|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939623|NCT00758498|OG000|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939624|NCT00758498|OG001|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939625|NCT00758498|OG002|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939626|NCT00758498|EG000|Reported Event|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939627|NCT00758498|EG001|Reported Event|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939628|NCT00758498|EG002|Reported Event|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
10939629|NCT00758524|BG000|Baseline|Core Period: LCI699 0.25 mg QD|Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939630|NCT00758524|BG001|Baseline|Core Period: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939631|NCT00758524|BG002|Baseline|Core Period: LCI699 1.0 mg QD|Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939632|NCT00758524|BG003|Baseline|Core Period: LCI699 0.5 mg BID|Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
10939633|NCT00758524|BG004|Baseline|Core Period: Eplerenone 50 mg BID|Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
10939634|NCT00758524|BG005|Baseline|Core Period: Placebo|Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
10939635|NCT00758524|BG006|Baseline|Total|Total of all reporting groups
10939636|NCT00758524|FG000|Participant Flow|Core Period: LCI699 0.25 mg QD|Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.
10939637|NCT00758524|FG001|Participant Flow|Core Period: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939638|NCT00758524|FG002|Participant Flow|Core Period: LCI699 1.0 mg QD|Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939639|NCT00758524|FG003|Participant Flow|Core Period: LCI699 0.5 mg BID|Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
10939640|NCT00758524|FG004|Participant Flow|Core Period: Eplerenone 50 mg BID|Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
10939641|NCT00758524|FG005|Participant Flow|Core Period: Placebo|Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
10939642|NCT00758524|FG006|Participant Flow|Withdrawal Period: LCI699 0.25 mg QD|Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939643|NCT00758524|FG007|Participant Flow|Withdrawal Period: LCI699 0.25 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939644|NCT00758524|FG008|Participant Flow|Withdrawal Period: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939645|NCT00758524|FG009|Participant Flow|Withdrawal Period: LCI699 0.5 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939646|NCT00758524|FG010|Participant Flow|Withdrawal Period: LCI699 1.0 mg QD|Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
11176957|NCT02038894|FG001|Participant Flow|Intubated With Propofol (IP)|"Anesthetic technique during (EGD)~Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia."
10939647|NCT00758524|FG011|Participant Flow|Withdrawal Period: LCI699 1.0 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939648|NCT00758524|FG012|Participant Flow|Withdrawal Period: LCI699 0.5 mg BID|Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939649|NCT00758524|FG013|Participant Flow|Withdrawal Period: LCI699 0.5 mg BID Placebo|Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939650|NCT00758524|FG014|Participant Flow|Withdrawal Period: Eplerenone 50 mg BID|Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939651|NCT00758524|FG015|Participant Flow|Withdrawal Period: Eplerenone 50 mg BID Placebo|Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
11176958|NCT02038894|FG002|Participant Flow|Native Airway - no Intubation|"Anesthetic technique during (EGD)~Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.~Propofol"
11192161|NCT02137499|OG000|Outcome|Healthy Subjects|Healthy participants treated with Small transcutaneous electrical stimulator
10939652|NCT00758524|FG016|Participant Flow|Withdrawal Period: Placebo|Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
10939653|NCT00758524|OG000|Outcome|Core Period: LCI699 0.25 mg QD|Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939654|NCT00758524|OG001|Outcome|Core Period: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939655|NCT00758524|OG002|Outcome|Core Period: LCI699 1.0 mg QD|Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939656|NCT00758524|OG003|Outcome|Core Period: LCI699 0.5 mg BID|Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
10939657|NCT00758524|OG004|Outcome|Core Period: Eplerenone 50 mg BID|Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
10939658|NCT00758524|OG005|Outcome|Core Period: Placebo|Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
10939659|NCT00758524|OG000|Outcome|Core Period: LCI699 0.25 mg QD|Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.
10939660|NCT00758524|OG003|Outcome|Core Period: LCI699 0.5 mg BID|Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
10939661|NCT00758524|OG000|Outcome|Withdrawal Period: LCI699 0.25 mg QD|Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939662|NCT00758524|OG001|Outcome|Withdrawal Period: LCI699 0.25 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939663|NCT00758524|OG002|Outcome|Withdrawal Period: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939664|NCT00758524|OG003|Outcome|Withdrawal Period: LCI699 0.5 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939665|NCT00758524|OG004|Outcome|Withdrawal Period: LCI699 1.0 mg QD|Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939666|NCT00758524|OG005|Outcome|Withdrawal Period: LCI699 1.0 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939667|NCT00758524|OG006|Outcome|Withdrawal Period: LCI699 0.5 mg BID|Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939668|NCT00758524|OG007|Outcome|Withdrawal Period: LCI699 0.5 mg BID Placebo|Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939669|NCT00758524|OG008|Outcome|Withdrawal Period: Eplerenone 50 mg BID|Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939670|NCT00758524|OG009|Outcome|Withdrawal Period: Eplerenone 50 mg BID Placebo|Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939671|NCT00758524|OG010|Outcome|Withdrawal Period: Placebo|Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
10939672|NCT00758524|EG000|Reported Event|Core Period: LCI699 0.25 mg QD|Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939673|NCT00758524|EG001|Reported Event|Core Period: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939674|NCT00758524|EG002|Reported Event|Core Period: LCI699 1.0 mg QD|Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
10939675|NCT00758524|EG003|Reported Event|Core Period: LCI699 0.5 mg BID|Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
10939676|NCT00758524|EG004|Reported Event|Core Period: Eplerenone 50 mg BID|Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
11234281|NCT02433379|FG000|Participant Flow|UNTOUCHED Study Participants|There were 1173 patients who were consented for participation in the UNTOUCHED Study. Of the 1173 participants enrolled 1116 were implanted or attempted for implant with an EMBLEM S-ICD and programmed with rate zones set at 200 bpm and 250 bpm per protocol. There were 57 enrolled subjects who were determined to be screen failures or were not attempted for implant. These subjects were not followed for the study and therefore not included in the study analyses/results.
10939677|NCT00758524|EG005|Reported Event|Core Period: Placebo|Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
10939678|NCT00758524|EG006|Reported Event|Withdrawal Period: LCI699 0.25 mg QD|Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939679|NCT00758524|EG007|Reported Event|Withdrawal Period: LCI699 0.25 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939680|NCT00758524|EG008|Reported Event|Withdrawal Period: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939681|NCT00758524|EG009|Reported Event|Withdrawal Period: LCI699 0.5 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939682|NCT00758524|EG010|Reported Event|Withdrawal Period: LCI699 1.0 mg QD|Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939683|NCT00758524|EG011|Reported Event|Withdrawal Period: LCI699 1.0 mg QD Placebo|Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
10939684|NCT00758524|EG012|Reported Event|Withdrawal Period: LCI699 0.5 mg BID|Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939685|NCT00758524|EG013|Reported Event|Withdrawal Period: LCI699 0.5 mg BID Placebo|Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939686|NCT00758524|EG014|Reported Event|Withdrawal Period: Eplerenone 50 mg BID|Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939687|NCT00758524|EG015|Reported Event|Withdrawal Period: Eplerenone 50 mg BID Placebo|Participants received eplerenone-matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
10939688|NCT00758524|EG016|Reported Event|Withdrawal Period: Placebo|Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
10939689|NCT00758550|BG000|Baseline|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
10939690|NCT00758550|BG001|Baseline|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
10939691|NCT00758550|BG002|Baseline|Total|Total of all reporting groups
10939692|NCT00758550|FG000|Participant Flow|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
10939693|NCT00758550|FG001|Participant Flow|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
10939694|NCT00758550|OG000|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
10939695|NCT00758550|OG001|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
10939696|NCT00758550|EG000|Reported Event|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
10939697|NCT00758550|EG001|Reported Event|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
10939698|NCT00758576|BG000|Baseline|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
10939699|NCT00758576|FG000|Participant Flow|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
10939700|NCT00758576|OG000|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
10939701|NCT00758576|EG000|Reported Event|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
10939702|NCT00758589|BG000|Baseline|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
10939703|NCT00758589|BG001|Baseline|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
10939704|NCT00758589|BG002|Baseline|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
10939705|NCT00758589|BG003|Baseline|Placebo|placebo oral tablet, twice daily
10939706|NCT00758589|BG004|Baseline|Total|Total of all reporting groups
10939707|NCT00758589|FG000|Participant Flow|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
10939708|NCT00758589|FG001|Participant Flow|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
10939709|NCT00758589|FG002|Participant Flow|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
10939710|NCT00758589|FG003|Participant Flow|Placebo|placebo oral tablet, twice daily
10939711|NCT00758589|OG000|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
10939712|NCT00758589|OG001|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
10939713|NCT00758589|OG002|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
10939714|NCT00758589|OG003|Outcome|Placebo|placebo oral tablet, twice daily
10939715|NCT00758589|EG000|Reported Event|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
10939716|NCT00758589|EG001|Reported Event|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
10939717|NCT00758589|EG002|Reported Event|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
10939718|NCT00758589|EG003|Reported Event|Placebo|placebo oral tablet, twice daily
10939719|NCT00758602|BG000|Baseline|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939720|NCT00758602|BG001|Baseline|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939721|NCT00758602|BG002|Baseline|Total|Total of all reporting groups
10939722|NCT00758602|FG000|Participant Flow|Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939723|NCT00758602|FG001|Participant Flow|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939724|NCT00758602|OG000|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939725|NCT00758602|OG001|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939726|NCT00758602|OG001|Outcome|MMFl, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939727|NCT00758602|EG000|Reported Event|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939728|NCT00758602|EG001|Reported Event|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
10939729|NCT00758667|BG000|Baseline|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
10939730|NCT00758667|BG001|Baseline|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
10939731|NCT00758667|BG002|Baseline|Total|Total of all reporting groups
10939732|NCT00758667|FG000|Participant Flow|Standard|Standard procedure or capsulectomy for removal of capsule;
10939733|NCT00758667|FG001|Participant Flow|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
10939734|NCT00758667|OG000|Outcome|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
10939735|NCT00758667|OG001|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
10939736|NCT00758667|OG000|Outcome|Standard|Standard procedure or capsulectomy for removal of capsule;
10939737|NCT00758667|EG000|Reported Event|Standard|Standard procedure or capsulectomy for removal of capsule;
10939738|NCT00758667|EG001|Reported Event|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
10939739|NCT00758680|BG000|Baseline|All Treated Participants|After a 2-week run-in/wash-off period, participants received doses of MK-1006 or matching placebo over a multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
10939740|NCT00758680|FG000|Participant Flow|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
10939741|NCT00758680|FG001|Participant Flow|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939742|NCT00758680|FG002|Participant Flow|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939743|NCT00758680|FG003|Participant Flow|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
11176959|NCT02038894|OG000|Outcome|Intubated With Sevoflurane (IS)|"Anesthetic technique during (EGD)~Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia."
11176960|NCT02038894|OG001|Outcome|Intubated With Propofol (IP)|"Anesthetic technique during (EGD)~Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia."
11176961|NCT02038894|OG002|Outcome|Native Airway - no Intubation|"Anesthetic technique during (EGD)~Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.~Propofol"
10939744|NCT00758680|FG004|Participant Flow|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939745|NCT00758680|FG005|Participant Flow|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939746|NCT00758680|FG006|Participant Flow|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939747|NCT00758680|FG007|Participant Flow|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
10939748|NCT00758680|FG008|Participant Flow|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
10939749|NCT00758680|FG009|Participant Flow|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
10939750|NCT00758680|OG000|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
10939751|NCT00758680|OG001|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939752|NCT00758680|OG002|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939753|NCT00758680|OG003|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939754|NCT00758680|OG004|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939755|NCT00758680|OG005|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939756|NCT00758680|OG006|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939757|NCT00758680|OG007|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
10939758|NCT00758680|OG008|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
10939759|NCT00758680|OG009|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
10939760|NCT00758680|OG007|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
10939761|NCT00758680|EG000|Reported Event|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
10939762|NCT00758680|EG001|Reported Event|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939763|NCT00758680|EG002|Reported Event|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939764|NCT00758680|EG003|Reported Event|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939765|NCT00758680|EG004|Reported Event|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939766|NCT00758680|EG005|Reported Event|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939767|NCT00758680|EG006|Reported Event|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
10939768|NCT00758680|EG007|Reported Event|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
10939769|NCT00758680|EG008|Reported Event|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
10939770|NCT00758680|EG009|Reported Event|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
10939771|NCT00758706|BG000|Baseline|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
10939772|NCT00758706|BG001|Baseline|Placebo|Placebo to AZD1236 twice daily(bid)
10939773|NCT00758706|BG002|Baseline|Total|Total of all reporting groups
10939774|NCT00758706|FG000|Participant Flow|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
10939775|NCT00758706|FG001|Participant Flow|Placebo|Placebo to AZD1236 twice daily(bid)
10939776|NCT00758706|OG000|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
10939777|NCT00758706|OG001|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
10939778|NCT00758706|EG000|Reported Event|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
10939779|NCT00758706|EG001|Reported Event|Placebo|Placebo to AZD1236 twice daily(bid)
10939780|NCT00758745|BG000|Baseline|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
10939781|NCT00758745|BG001|Baseline|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
10939782|NCT00758745|BG002|Baseline|Total|Total of all reporting groups
10939783|NCT00758745|FG000|Participant Flow|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
10939784|NCT00758745|FG001|Participant Flow|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
10939785|NCT00758745|OG000|Outcome|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
10939786|NCT00758745|OG001|Outcome|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
10939787|NCT00758745|EG000|Reported Event|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
10939788|NCT00758745|EG001|Reported Event|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
10939789|NCT00758758|BG000|Baseline|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
10939790|NCT00758758|BG001|Baseline|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
10939791|NCT00758758|BG002|Baseline|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
10939792|NCT00758758|BG003|Baseline|Autograft Only - Illiac Crest|Autograft only - Illiac crest
10939793|NCT00758758|BG004|Baseline|Autograft With Plate|Autograft with plate
10939794|NCT00758758|BG005|Baseline|Allograft With Plate|Allograft with plate
10939795|NCT00758758|BG006|Baseline|Autograft 2 Levels With Plate|Autograft 2 levels with plate
10939796|NCT00758758|BG007|Baseline|Allograft 2 Levels With Plate|Allograft 2 levels with plate
10939797|NCT00758758|BG008|Baseline|Total|Total of all reporting groups
10939798|NCT00758758|FG000|Participant Flow|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
10939799|NCT00758758|FG001|Participant Flow|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
10939800|NCT00758758|FG002|Participant Flow|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
10939801|NCT00758758|FG003|Participant Flow|Autograft Only - Illiac Crest|Autograft only - illiac crest
10939802|NCT00758758|FG004|Participant Flow|Autograft 1 Level With Plate|Autograft 1 level plated
10939803|NCT00758758|FG005|Participant Flow|Allograft 1 Level With Plate|Allograft 1 level plated
10939804|NCT00758758|FG006|Participant Flow|Allograft 2 Levels With Plate|Allograft 2 levels with plate
10939805|NCT00758758|FG007|Participant Flow|Autograft 2 Levels With Plate|Autograft 2 levels with plate
10939806|NCT00758758|OG000|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel with out plate
10939807|NCT00758758|OG001|Outcome|One Level Hedrocel With Plate|Hedrocel with a plate
10939808|NCT00758758|OG002|Outcome|Two Levels Plated Hedrocel|2 Levels Plated Hedrocel
10939809|NCT00758758|OG003|Outcome|Illiac Crest Autograft - no Plate|Iliac Crest Autograft
10939810|NCT00758758|OG004|Outcome|Plated Autograft|Plated Autograft
10939811|NCT00758758|OG005|Outcome|Plated Allograft|Plated Allograft
10939812|NCT00758758|OG006|Outcome|2 Levels Plated Autograft|2 Levels with plated Autograft
10939813|NCT00758758|OG007|Outcome|2 Levels With Plated Allograft|2 Levels with plated Allograft
10939814|NCT00758758|OG000|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel without plate
10939815|NCT00758758|OG001|Outcome|Hedrocel With Plate|Hedrocel with a plate
10939816|NCT00758758|OG002|Outcome|2 Levels Hedrocel With Plate|2 Levels Plated Hedrocel
10939817|NCT00758758|OG003|Outcome|Illiac Crest Autograft|Iliac Crest Autograft
10939818|NCT00758758|OG004|Outcome|Autograft With Plate|Plated Autograft
10939819|NCT00758758|OG005|Outcome|Allograft With Plate|Plated Allograft
10939820|NCT00758758|OG006|Outcome|Autograft With 2 Plates|2 Levels with plated Autograft
10939821|NCT00758758|OG007|Outcome|Allograft With 2 Plates|2 Levels with plated Allograft
10939822|NCT00758758|EG000|Reported Event|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
10939823|NCT00758758|EG001|Reported Event|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
10939824|NCT00758758|EG002|Reported Event|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
10939825|NCT00758758|EG003|Reported Event|Autograft Only - Illiac Crest|Autograft only - Illiac crest
10939826|NCT00758758|EG004|Reported Event|Autograft With Plate|Autograft with plate
10939827|NCT00758758|EG005|Reported Event|Allograft With Plate|Allograft with plate
10939828|NCT00758758|EG006|Reported Event|Autograft 2 Levels With Plate|Autograft 2 levels with plate
10939829|NCT00758758|EG007|Reported Event|Allograft 2 Levels With Plate|Allograft 2 levels with plate
10939830|NCT00758771|BG000|Baseline|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
10939831|NCT00758771|BG001|Baseline|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
10939832|NCT00758771|BG002|Baseline|Total|Total of all reporting groups
10939833|NCT00758771|FG000|Participant Flow|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
10939834|NCT00758771|FG001|Participant Flow|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
10939835|NCT00758771|OG000|Outcome|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
10939836|NCT00758771|OG001|Outcome|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
10939837|NCT00758771|EG000|Reported Event|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
10939838|NCT00758771|EG001|Reported Event|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
10939839|NCT00758784|BG000|Baseline|Bromfenac Ophthalmic Solution 0.06%|bromfenac ophthalmic solution 0.06% bilaterally twice a day
10939840|NCT00758784|FG000|Participant Flow|Bromfenac Ophthalmic Solution 0.06%|bromfenac ophthalmic solution 0.06% bilaterally twice a day
10939841|NCT00758784|OG000|Outcome|Bromfenac Ophthalmic Solution 0.06%|bromfenac ophthalmic solution 0.06% bilaterally twice a day
10939842|NCT00758784|EG000|Reported Event|Bromfenac Ophthalmic Solution 0.06%|bromfenac ophthalmic solution 0.06% bilaterally twice a day
10939843|NCT00758836|BG000|Baseline|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
10939844|NCT00758836|BG001|Baseline|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
10939845|NCT00758836|BG002|Baseline|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
10939846|NCT00758836|BG003|Baseline|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
10939847|NCT00758836|BG004|Baseline|Total|Total of all reporting groups
10939848|NCT00758836|FG000|Participant Flow|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
10939849|NCT00758836|FG001|Participant Flow|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
10939850|NCT00758836|FG002|Participant Flow|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
10939851|NCT00758836|FG003|Participant Flow|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
10939852|NCT00758836|OG000|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
10939853|NCT00758836|OG001|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
10939854|NCT00758836|OG002|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
10939855|NCT00758836|OG003|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
10939856|NCT00758836|EG000|Reported Event|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
10939857|NCT00758836|EG001|Reported Event|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
10939858|NCT00758836|EG002|Reported Event|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
10939859|NCT00758836|EG003|Reported Event|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
10939860|NCT00758862|BG000|Baseline|TD1414|2% TD1414 Cream: Application 3 times daily for 7 days
10939861|NCT00758862|FG000|Participant Flow|TD1414|2% TD1414 Cream: Application 3 times on lesions area(s) daily for 7 days. A maximum of 0.5g of cream on a 100 cm2 lesion area was to be used per application.
10939862|NCT00758862|OG000|Outcome|TD1414|2% TD1414 Cream: Application 3 times daily for 7 days
10939863|NCT00758862|EG000|Reported Event|TD1414|2% TD1414 Cream: Application 3 times daily for 7 days
10939864|NCT00759031|BG000|Baseline|Fluoride 1st, Then Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
10939865|NCT00759031|BG001|Baseline|Triclosan + Fluoride 1st, Then Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
10939866|NCT00759031|BG002|Baseline|Total|Total of all reporting groups
10939867|NCT00759031|FG000|Participant Flow|Fluoride 1st, Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
10939868|NCT00759031|FG001|Participant Flow|Triclosan + Fluoride 1st, Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
10939869|NCT00759031|OG000|Outcome|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
10939870|NCT00759031|OG001|Outcome|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
10939871|NCT00759031|EG000|Reported Event|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
10939872|NCT00759031|EG001|Reported Event|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
10939873|NCT00759096|BG000|Baseline|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
10939874|NCT00759096|FG000|Participant Flow|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
10939875|NCT00759096|OG000|Outcome|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
11234282|NCT02433379|OG000|Outcome|S-ICD|"Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.~EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp"
11234283|NCT02433379|OG000|Outcome|S-ICD (EMBLEM Model A209)|"The first 200 subjects implanted with an EMBLEM S-ICD (Model A209) S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.~EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp"
10939876|NCT00759096|EG000|Reported Event|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
10939877|NCT00759109|BG000|Baseline|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
10939878|NCT00759109|BG001|Baseline|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
10939879|NCT00759109|BG002|Baseline|Total|Total of all reporting groups
10939880|NCT00759109|FG000|Participant Flow|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
10939881|NCT00759109|FG001|Participant Flow|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
10939882|NCT00759109|OG000|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
10939883|NCT00759109|OG001|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
10939884|NCT00759109|EG000|Reported Event|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
10939885|NCT00759109|EG001|Reported Event|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
10939886|NCT00759148|BG000|Baseline|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
10939887|NCT00759148|BG001|Baseline|Vehicle|Moxifloxacin AF Vehicle, 1 drop in each eye twice daily for 3 days
10939888|NCT00759148|BG002|Baseline|Total|Total of all reporting groups
10939889|NCT00759148|FG000|Participant Flow|Moxifloxacin AF|Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
10939890|NCT00759148|FG001|Participant Flow|Vehicle|Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
10939891|NCT00759148|OG000|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
10939892|NCT00759148|OG001|Outcome|Vehicle|Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
10939893|NCT00759148|EG000|Reported Event|Moxifloxacin AF|Subjects exposed to Moxifloxacin AF
10939894|NCT00759148|EG001|Reported Event|Vehicle|Subjects exposed to Moxifloxacin AF Vehicle
10939895|NCT00759161|BG000|Baseline|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939896|NCT00759161|FG000|Participant Flow|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
11176962|NCT02038894|OG003|Outcome|IS and IP|Grouping the intubated with sevoflurane group (IS) with the intubated with propofol group (IP) since the airway management is the same for both groups (endotracheal intubation) Table 2
11176963|NCT02038894|OG004|Outcome|IP and NA|Grouping the intubated propofol group (IP) with the native airway group (NA) since they received the same medication during the procedure (propofol). Table 2
11176964|NCT02038894|OG003|Outcome|IS and IP|Grouped together by the same airway management during anesthesia (Endotracheal intubation). Table 2
11176965|NCT02038894|OG004|Outcome|IP and NA|Grouped together by the same medication use for anesthesia maintenance (propofol). Table 2
11176966|NCT02038894|EG000|Reported Event|Intubated With Sevoflurane (IS)|"Anesthetic technique during (EGD)~Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia."
11176967|NCT02038894|EG001|Reported Event|Intubated With Propofol (IP)|"Anesthetic technique during (EGD)~Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia."
11176968|NCT02038894|EG002|Reported Event|Native Airway - no Intubation|"Anesthetic technique during (EGD)~Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.~Propofol"
10939897|NCT00759161|OG000|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
11176969|NCT02038907|BG000|Baseline|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
10939898|NCT00759161|OG000|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
11176970|NCT02038907|BG001|Baseline|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11176971|NCT02038907|BG002|Baseline|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11176972|NCT02038907|BG003|Baseline|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11176973|NCT02038907|BG004|Baseline|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
11176974|NCT02038907|BG005|Baseline|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11176975|NCT02038907|BG006|Baseline|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11176976|NCT02038907|BG007|Baseline|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11176977|NCT02038907|BG008|Baseline|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11176978|NCT02038907|BG009|Baseline|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11176979|NCT02038907|BG010|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
11176980|NCT02038907|BG011|Baseline|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11176981|NCT02038907|BG012|Baseline|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11176982|NCT02038907|BG013|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11176983|NCT02038907|BG014|Baseline|Total|Total of all reporting groups
11176984|NCT02038907|FG000|Participant Flow|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
11176985|NCT02038907|FG001|Participant Flow|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11176986|NCT02038907|FG002|Participant Flow|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
10939899|NCT00759161|OG001|Outcome|AN2728 Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939900|NCT00759161|OG001|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939901|NCT00759161|EG000|Reported Event|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
10939902|NCT00759174|BG000|Baseline|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
10939903|NCT00759174|BG001|Baseline|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
10939904|NCT00759174|BG002|Baseline|Total|Total of all reporting groups
10939905|NCT00759174|FG000|Participant Flow|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
10939906|NCT00759174|FG001|Participant Flow|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
10939907|NCT00759174|OG000|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
10939908|NCT00759174|OG001|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
10939909|NCT00759174|OG000|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the week preceding the symptom onset day.
10939910|NCT00759174|OG001|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 7 weeks preceding the case window.
11176987|NCT02038907|FG003|Participant Flow|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11176988|NCT02038907|FG004|Participant Flow|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
11176989|NCT02038907|FG005|Participant Flow|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
10939911|NCT00759174|EG000|Reported Event|Potential NAION Cases|All participants who met pre-defined potential acute NAION criteria and were either exposed or not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
11176990|NCT02038907|FG006|Participant Flow|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
10939912|NCT00759187|BG000|Baseline|Fluoride|
10939913|NCT00759187|BG001|Baseline|Fluoride/Triclosan|
10939914|NCT00759187|BG002|Baseline|Chlorhexidine Gluconate|
10939915|NCT00759187|BG003|Baseline|Total|Total of all reporting groups
10939916|NCT00759187|FG000|Participant Flow|Fluoride|
10939917|NCT00759187|FG001|Participant Flow|Fluoride/Triclosan|
10939918|NCT00759187|FG002|Participant Flow|Chlorhexidine Gluconate|
10939919|NCT00759187|OG000|Outcome|Fluoride|
10939920|NCT00759187|OG001|Outcome|Fluoride/Triclosan|
10939921|NCT00759187|OG002|Outcome|Chlorhexidine Gluconate|
10939922|NCT00759187|EG000|Reported Event|Fluoride|
10939923|NCT00759187|EG001|Reported Event|Fluoride/Triclosan|
10939924|NCT00759187|EG002|Reported Event|Chlorhexidine Gluconate|
10939925|NCT00759330|BG000|Baseline|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
10939926|NCT00759330|BG001|Baseline|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
10939927|NCT00759330|BG002|Baseline|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
10939928|NCT00759330|BG003|Baseline|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
10939929|NCT00759330|BG004|Baseline|Total|Total of all reporting groups
10939930|NCT00759330|FG000|Participant Flow|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
10939931|NCT00759330|FG001|Participant Flow|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
10939932|NCT00759330|FG002|Participant Flow|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
10939933|NCT00759330|FG003|Participant Flow|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
10939934|NCT00759330|OG000|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
10939935|NCT00759330|OG001|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
11176991|NCT02038907|FG007|Participant Flow|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11176992|NCT02038907|FG008|Participant Flow|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11176993|NCT02038907|FG009|Participant Flow|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11176994|NCT02038907|FG010|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
11176995|NCT02038907|FG011|Participant Flow|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
10939936|NCT00759330|OG002|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
10939937|NCT00759330|OG003|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
10939938|NCT00759330|OG003|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
10939939|NCT00759330|EG000|Reported Event|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
10939940|NCT00759330|EG001|Reported Event|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
10939941|NCT00759330|EG002|Reported Event|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
10939942|NCT00759330|EG003|Reported Event|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
10939943|NCT00759356|BG000|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
10939944|NCT00759356|BG001|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
10939945|NCT00759356|BG002|Baseline|Total|Total of all reporting groups
11176996|NCT02038907|FG012|Participant Flow|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11176997|NCT02038907|FG013|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11192162|NCT02137499|OG001|Outcome|Superficial Venous Insufficiency|Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator
10939946|NCT00759356|FG000|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
10939947|NCT00759356|FG001|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
10939948|NCT00759356|OG000|Outcome|Morphine Sulfate SR 200 mg Capsule|
10939949|NCT00759356|OG001|Outcome|KADIAN® 200 mg Capsule|
10939950|NCT00759356|EG000|Reported Event|Arm 1: Treatment A Followed by Treatment B|
10939951|NCT00759356|EG001|Reported Event|Arm 2: Treatment B Followed by Treatment A|
11176998|NCT02038907|OG000|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
11176999|NCT02038907|OG001|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11177000|NCT02038907|OG002|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11177001|NCT02038907|OG003|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
10939952|NCT00759395|BG000|Baseline|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
10939953|NCT00759395|BG001|Baseline|Placebo|Placebo BID, Tablet, Oral, Daily
11177002|NCT02038907|OG004|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
11177003|NCT02038907|OG005|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
10939954|NCT00759395|BG002|Baseline|Total|Total of all reporting groups
10939955|NCT00759395|FG000|Participant Flow|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
10939956|NCT00759395|FG001|Participant Flow|Placebo|Placebo BID, Tablet, Oral, Daily
10939957|NCT00759395|OG000|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
10939958|NCT00759395|OG001|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
10939959|NCT00759395|EG000|Reported Event|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
10939960|NCT00759395|EG001|Reported Event|Placebo|Placebo BID, Tablet, Oral, Daily
11177004|NCT02038907|OG006|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
10939961|NCT00759408|BG000|Baseline|BQ-123|BQ-123 (6-120 µg/min) will be administered intravenously.
10939962|NCT00759408|FG000|Participant Flow|BQ-123|BQ-123 (6-120 µg/min) will be administered intravenously.
11177005|NCT02038907|OG007|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11177006|NCT02038907|OG008|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11177007|NCT02038907|OG009|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11177008|NCT02038907|OG010|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
10939963|NCT00759408|OG000|Outcome|BQ-123|BQ-123 (6-120 µg/min) will be administered intravenously.
10939964|NCT00759408|EG000|Reported Event|BQ-123|BQ-123 (6-120 µg/min) will be administered intravenously.
10939965|NCT00759473|BG000|Baseline|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
10939966|NCT00759473|BG001|Baseline|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
10939967|NCT00759473|BG002|Baseline|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
10939968|NCT00759473|BG003|Baseline|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
10939969|NCT00759473|BG004|Baseline|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue expsosure sessions, and at the one-week follow-up session. Participants also received cognitive skills training.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
10939970|NCT00759473|BG005|Baseline|Total|Total of all reporting groups
10939971|NCT00759473|FG000|Participant Flow|DCS/DCS/DCS/ Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) for each of 3 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
10939972|NCT00759473|FG001|Participant Flow|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
10939973|NCT00759473|FG002|Participant Flow|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
10939974|NCT00759473|FG003|Participant Flow|DCS/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at 2 cue cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
10939975|NCT00759473|FG004|Participant Flow|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session. Participants also received cognitive skills training. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
10939976|NCT00759473|OG000|Outcome|DCS Only|Participants received 50 mg of DCS at each of 3 cue exposure sessions and placebo at the one-week follow-up session.
10939977|NCT00759473|OG001|Outcome|Placebo Only|Participants received a placebo at each of 3 cue exposure sessions and at the one-week follow-up session.
10939978|NCT00759473|OG002|Outcome|DCS/ Placebo/DCS|Participants received 50 mg of DCS at the 1st and 3rd cue exposure sessions, and placebo at the 2nd cue exposure session and the one-week follow-up session.
10939979|NCT00759473|OG003|Outcome|DCS Plus Cognitive Skills Training|Participants received 50 mg of DCS at 2 cue extinction sessions and placebo at the one-week follow-up session. Participants also received cognitive skills training.
10939980|NCT00759473|OG004|Outcome|Placebo Plus Cognitive Skills Training|Participants received a placebo at 2 cue extinction sessions and at the one-week follow-up session. Participants also received cognitive skills training.
10939981|NCT00759473|EG000|Reported Event|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.
10939982|NCT00759473|EG001|Reported Event|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.
10939983|NCT00759473|EG002|Reported Event|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.
10939984|NCT00759473|EG003|Reported Event|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session.
10939985|NCT00759473|EG004|Reported Event|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session.
10939986|NCT00759525|BG000|Baseline|All Study Participants|
10939987|NCT00759525|FG000|Participant Flow|Glycyrrhetinic Acid First, Then Placebo|Glycyrrhetic Acid-130 mg/day for 14 days followed by placebo
10939988|NCT00759525|FG001|Participant Flow|Placebo First, Then Glycyrrhetinic Acid|Placebo followed by Glycyrrhetic Acid-130 mg/day for 14 days
10939989|NCT00759525|OG000|Outcome|Glycyrrhinitic Acid|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
10939990|NCT00759525|OG001|Outcome|Placebo|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
10939991|NCT00759525|EG000|Reported Event|Glycyrrhetinic Acid First, Then Placebo|Healthy subjects without medical condition.
10939992|NCT00759525|EG001|Reported Event|Placebo First, Then Glycyrrhetinic Acid|Healthy subjects without medical condition.
10939993|NCT00759564|BG000|Baseline|CP-70,429 (800 mg) + PF-03709270: Normal Renal Impairment|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10939994|NCT00759564|BG001|Baseline|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10939995|NCT00759564|BG002|Baseline|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP--70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10939996|NCT00759564|BG003|Baseline|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10939997|NCT00759564|BG004|Baseline|CP-70,429 (200 mg) + PF-03709270: Severe Renal Function|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP--70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF--03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10939998|NCT00759564|BG005|Baseline|Total|Total of all reporting groups
10939999|NCT00759564|FG000|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Normal Renal Function|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10940000|NCT00759564|FG001|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10940001|NCT00759564|FG002|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP--70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10940002|NCT00759564|FG003|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10940003|NCT00759564|FG004|Participant Flow|CP-70,429 (200 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP--70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF--03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
10940004|NCT00759564|OG000|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
10940005|NCT00759564|OG001|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
10940006|NCT00759564|OG002|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
10940007|NCT00759564|OG003|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
11177009|NCT02038907|OG011|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11177010|NCT02038907|OG012|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
10940008|NCT00759564|OG000|Outcome|PF--03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF--03709270 1000 mg tablet in second intervention period.
10940009|NCT00759564|OG001|Outcome|PF--03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF--03709270 1000 mg tablet in second intervention period.
10940010|NCT00759564|OG002|Outcome|PF--03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF--03709270 1000 mg tablet in second intervention period.
10940011|NCT00759564|OG003|Outcome|PF--03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF--03709270 1000 mg tablet in second intervention period.
10940012|NCT00759564|OG001|Outcome|PF--03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940013|NCT00759564|OG000|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF--03709270 1000 mg tablet in second intervention period.
11177011|NCT02038907|OG013|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11177012|NCT02038907|OG000|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
11177013|NCT02038907|OG001|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
10940014|NCT00759564|OG003|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940015|NCT00759564|OG000|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940016|NCT00759564|OG001|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940017|NCT00759564|OG003|Outcome|PF--03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF--03709270 1000 mg tablet in second intervention period.
10940018|NCT00759564|OG002|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940019|NCT00759564|OG003|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
10940020|NCT00759564|OG004|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
10940021|NCT00759564|OG005|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940022|NCT00759564|OG006|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940023|NCT00759564|OG007|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940024|NCT00759564|OG008|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940025|NCT00759564|EG000|Reported Event|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
10940026|NCT00759564|EG001|Reported Event|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
10940027|NCT00759564|EG002|Reported Event|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
10940028|NCT00759564|EG003|Reported Event|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
10940029|NCT00759564|EG004|Reported Event|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
10940030|NCT00759564|EG005|Reported Event|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940031|NCT00759564|EG006|Reported Event|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940032|NCT00759564|EG007|Reported Event|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
10940033|NCT00759564|EG008|Reported Event|PF-03709270 (1000 mg): Severe Renal|Participants with severe renal impairment received a single oral dose of PF-03709270 1000 mg tablet under fasted condition in second intervention period.
10940034|NCT00759603|BG000|Baseline|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
10940035|NCT00759603|FG000|Participant Flow|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
10940036|NCT00759603|OG000|Outcome|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
10940037|NCT00759603|EG000|Reported Event|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
10940038|NCT00759642|BG000|Baseline|Lapatinib|"lapatinib~lapatinib: lapatinib 1500 mg PO daily"
11192163|NCT02137499|OG002|Outcome|Deep Venous Insufficiency|Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator
10940039|NCT00759642|FG000|Participant Flow|Lapatinib|"lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)~lapatinib: lapatinib 1500 mg PO daily"
10940040|NCT00759642|OG000|Outcome|Lapatinib|"lapatinib + Endocrine therapy~lapatinib: lapatinib 1500 mg PO daily"
10940041|NCT00759642|EG000|Reported Event|Lapatinib|"lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)~lapatinib: lapatinib 1500 mg PO daily"
10940042|NCT00759668|BG000|Baseline|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
10940043|NCT00759668|BG001|Baseline|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
10940044|NCT00759668|BG002|Baseline|Total|Total of all reporting groups
10940045|NCT00759668|FG000|Participant Flow|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
10940046|NCT00759668|FG001|Participant Flow|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
10940047|NCT00759668|OG000|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
10940048|NCT00759668|OG001|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
10940049|NCT00759668|EG000|Reported Event|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
11177014|NCT02038907|EG000|Reported Event|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
10940050|NCT00759668|EG001|Reported Event|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
10940051|NCT00759681|BG000|Baseline|Control|Control Treatment: Gelfoam and Thrombin
10940052|NCT00759681|BG001|Baseline|Investigational Device|Investigational Treatment: ArterX Surgical Sealant
10940053|NCT00759681|BG002|Baseline|Total|Total of all reporting groups
10940054|NCT00759681|FG000|Participant Flow|Control: Gelfoam and Thrombin|Gelfoam PlusTM is used to seal suture lines of arterial grafts or patches made from PTFE and Dacron. Gelfoam is a sterile compressed sponge and Thrombin is the last enzyme in the clotting cascade.
10940055|NCT00759681|FG001|Participant Flow|Investigational Device: ArterX Surgical Sealant|ArterX is a two-component sealant provided in a double barreled syringe. The main components are bovine serum albumin and a polyaldehyde formed from polymerized glutaraldehyde. The solutions are dispensed through a double plunger, mixing the two components in a 1:1 ratio by passing them through a specially designed mixing tip, delivering up to 2 ml volume of each component.
10940056|NCT00759681|OG000|Outcome|Control Treatment|Control Treatment: Gelfoam and Thrombin
10940057|NCT00759681|OG001|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
10940058|NCT00759681|OG000|Outcome|Control Treatment|Control Treatment with Gelfoam and Thrombin
10940059|NCT00759681|EG000|Reported Event|2. Gelfoam and Thrombin|Gelfoam and Thrombin
10940060|NCT00759681|EG001|Reported Event|1. ArterX Surgical Sealant|ArterX Surgical Sealant
10940061|NCT00759707|BG000|Baseline|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
11177015|NCT02038907|EG001|Reported Event|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
10940062|NCT00759707|FG000|Participant Flow|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
10940063|NCT00759707|OG000|Outcome|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
10940064|NCT00759707|EG000|Reported Event|Study Population|All 19 study subjects. Each subject qualified for the study on the basis of a continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein.
10940065|NCT00759759|BG000|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
10940066|NCT00759759|BG001|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
10940067|NCT00759759|BG002|Baseline|Total|Total of all reporting groups
10940068|NCT00759759|FG000|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
10940069|NCT00759759|FG001|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
10940070|NCT00759759|OG000|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
10940071|NCT00759759|OG001|Outcome|KADIAN® 100mg Caps by Alpharma|
10940072|NCT00759759|EG000|Reported Event|Arm 1: Treatment A Followed by Treatment B|
10940073|NCT00759759|EG001|Reported Event|Arm 2: Treatment B Followed by Treatment A|
10963440|NCT00871975|BG000|Baseline|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
10963441|NCT00871975|FG000|Participant Flow|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
10940074|NCT00759772|BG000|Baseline|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
10940075|NCT00759772|BG001|Baseline|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
10940076|NCT00759772|BG002|Baseline|Total|Total of all reporting groups
10940077|NCT00759772|FG000|Participant Flow|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
10940078|NCT00759772|FG001|Participant Flow|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
10940079|NCT00759772|OG000|Outcome|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
10940080|NCT00759772|OG001|Outcome|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
10940081|NCT00759772|EG000|Reported Event|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
10940082|NCT00759772|EG001|Reported Event|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
10940083|NCT00759785|BG000|Baseline|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
10940084|NCT00759785|BG001|Baseline|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
10940085|NCT00759785|BG002|Baseline|Total|Total of all reporting groups
10940086|NCT00759785|FG000|Participant Flow|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
10940087|NCT00759785|FG001|Participant Flow|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
10940088|NCT00759785|OG000|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
10940089|NCT00759785|OG001|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
10940090|NCT00759785|EG000|Reported Event|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
10940091|NCT00759785|EG001|Reported Event|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
10940092|NCT00759798|BG000|Baseline|Fludarabine, Cyclophosphamide, Rituximab|"Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)~Fludarabine: 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.~Cyclophosphamide: 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.~Rituximab: 375 mg/m2 given intravenously on Day 1 of Course 1~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)"
10940093|NCT00759798|FG000|Participant Flow|Fludarabine, Cyclophosphamide, Rituximab|"Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)~Fludarabine: 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.~Cyclophosphamide: 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.~Rituximab: 375 mg/m2 given intravenously on Day 1 of Course 1~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)"
10940094|NCT00759798|OG000|Outcome|Fludarabine, Cyclophosphamide, Rituximab|"Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)~Fludarabine: 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.~Cyclophosphamide: 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.~Rituximab: 375 mg/m2 given intravenously on Day 1 of Course 1~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)"
10940095|NCT00759798|EG000|Reported Event|Fludarabine, Cyclophosphamide, Rituximab|"Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)~Fludarabine: 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.~Cyclophosphamide: 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.~Rituximab: 375 mg/m2 given intravenously on Day 1 of Course 1~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)"
10940096|NCT00759811|BG000|Baseline|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
10940097|NCT00759811|BG001|Baseline|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
10940098|NCT00759811|BG002|Baseline|Total|Total of all reporting groups
10940099|NCT00759811|FG000|Participant Flow|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
10940100|NCT00759811|FG001|Participant Flow|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
10940101|NCT00759811|OG000|Outcome|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
10940102|NCT00759811|OG001|Outcome|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
10940103|NCT00759811|EG000|Reported Event|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
10940104|NCT00759811|EG001|Reported Event|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
10940105|NCT00759863|BG000|Baseline|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
10940106|NCT00759863|BG001|Baseline|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
10940107|NCT00759863|BG002|Baseline|Total|Total of all reporting groups
10940108|NCT00759863|FG000|Participant Flow|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
10940109|NCT00759863|FG001|Participant Flow|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
10940110|NCT00759863|OG000|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
10940111|NCT00759863|OG001|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
10940112|NCT00759863|EG000|Reported Event|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
10940113|NCT00759863|EG001|Reported Event|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
10940114|NCT00759876|BG000|Baseline|Ataluren|Participants received ataluren 3 times per day with meals at doses of 20 mg/kg (breakfast), 20 mg/kg (lunch), and 40 mg/kg (dinner) for up to 89 weeks.
10940115|NCT00759876|FG000|Participant Flow|Ataluren|Participants received ataluren 3 times per day with meals at doses of 20 mg/kg (breakfast), 20 mg/kg (lunch), and 40 mg/kg (dinner) for up to 89 weeks.
10940116|NCT00759876|OG000|Outcome|Ataluren|Participants received ataluren 3 times per day with meals at doses of 20 mg/kg (breakfast), 20 mg/kg (lunch), and 40 mg/kg (dinner) for up to 89 weeks.
10940117|NCT00759876|EG000|Reported Event|Ataluren|Participants received ataluren 3 times per day with meals at doses of 20 mg/kg (breakfast), 20 mg/kg (lunch), and 40 mg/kg (dinner) for up to 89 weeks.
10940118|NCT00759902|BG000|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
10940119|NCT00759902|BG001|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
10940120|NCT00759902|BG002|Baseline|Total|Total of all reporting groups
10940121|NCT00759902|FG000|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
10940122|NCT00759902|FG001|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
10940123|NCT00759902|OG000|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
10940124|NCT00759902|OG001|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
10940125|NCT00759902|EG000|Reported Event|Arm 1: Treatment A Followed by Treatment B|
10940126|NCT00759902|EG001|Reported Event|Arm 2: Treatment B Followed by Treatment A|
10940127|NCT00759915|BG000|Baseline|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
10940128|NCT00759915|BG001|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
10940129|NCT00759915|BG002|Baseline|Total|Total of all reporting groups
10940130|NCT00759915|FG000|Participant Flow|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
10940131|NCT00759915|FG001|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
10940132|NCT00759915|OG000|Outcome|KADIAN (2 x 10mg) Capsules|
10940133|NCT00759915|OG001|Outcome|KADIAN 20mg Capsules|
10940134|NCT00759915|EG000|Reported Event|Arm 1: Treatment A Followed by Treatment B|
10940135|NCT00759915|EG001|Reported Event|Arm 2: Treatment B Followed by Treatment A|
10940136|NCT00759941|BG000|Baseline|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
10940137|NCT00759941|BG001|Baseline|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
10940138|NCT00759941|BG002|Baseline|Total|Total of all reporting groups
10940139|NCT00759941|FG000|Participant Flow|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
10940140|NCT00759941|FG001|Participant Flow|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
10940141|NCT00759941|OG000|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
10940142|NCT00759941|OG001|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
10940143|NCT00759941|EG000|Reported Event|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
10940144|NCT00759941|EG001|Reported Event|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
10940145|NCT00759954|BG000|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
10940146|NCT00759954|BG001|Baseline|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
10940147|NCT00759954|BG002|Baseline|Total|Total of all reporting groups
10940148|NCT00759954|FG000|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
10940149|NCT00759954|FG001|Participant Flow|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
10940150|NCT00759954|OG000|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
10940151|NCT00759954|OG001|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
10940152|NCT00759954|EG000|Reported Event|Arm 1: Treatment A Followed by Treatment B|
10940153|NCT00759954|EG001|Reported Event|Arm 2: Treatment B Followed by Treatment A|
10940154|NCT00759967|BG000|Baseline|All Participants|All patients in the study were randomized after the 3 month run in phase to either Conventional HD or Short Daily HD for 3 months and then crossed over to the other treatment arm for 3 months
10940155|NCT00759967|FG000|Participant Flow|Conventional Hemodialysis First, Then Short Daily Hemodialysis|"After a 3 month run-in period patients who are randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. BP was monitored according to the Canadian hypertension guidelines both pre and post each dialysis session. Antihypertensive medication were adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period, extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.~In this group 10 participants started and completed the first intervention: Conventional Hemodialysis first (Period Table 1; Left Column). These 10 participants then started the second intervention: Short Daily Hemodialysis (Period Table 2: Left Column), of which 8 participants completed the Short Daily Hemodialysis."
10940156|NCT00759967|FG001|Participant Flow|Short Daily Hemodialysis First, Then Conventional Hemodialysis|"After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). Blood pressure was monitored according to the Canadian hypertension guidelines both pre and post each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period, extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.~In this group 9 participants started and completed the first intervention: Short Daily Hemodialysis first (Period Table 1: Right Column). These 9 participants then started the second intervention: Conventional Hemodialysis (Period Table 2: Right Column). All 9 participants finished conventional dialysis."
10940157|NCT00759967|OG000|Outcome|Short Daily Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
10940158|NCT00759967|OG001|Outcome|Conventional Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
10940159|NCT00759967|OG000|Outcome|Short Daily Hemodialysis|"After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.~Below shows the results of the extracellular fluid volume"
10940160|NCT00759967|OG001|Outcome|Conventional Hemodialysis|"After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.~Below shows the results of the extracellular fluid volume"
10940161|NCT00759967|OG000|Outcome|Short Daily Hemodialysis First, Then Conventional Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
10940162|NCT00759967|OG001|Outcome|Conventional Hemodialysis First, Then Short Daily Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
10940163|NCT00759967|EG000|Reported Event|Short Daily Hemodialysis|After a 3 month run-in period patients who are randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication wer adjusted accordingly to maintain BP within the guidelines.At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress will be collected.
11177016|NCT02038907|EG002|Reported Event|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
11177017|NCT02038907|EG003|Reported Event|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
10940164|NCT00759967|EG001|Reported Event|Conventional Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines.At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
10940165|NCT00760006|BG000|Baseline|Unasyn Antibiotic Arm|"Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
10940166|NCT00760006|BG001|Baseline|Saline Placebo Arm|"Other Names:~Salt solution~Saline Solution~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
10940167|NCT00760006|BG002|Baseline|Total|Total of all reporting groups
10940168|NCT00760006|FG000|Participant Flow|Unasyn Antibiotic Arm|"Active Comparator: Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
10940169|NCT00760006|FG001|Participant Flow|Saline Placebo Arm|"Other Names:~Salt solution~Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
10940170|NCT00760006|OG000|Outcome|Unasyn Antibiotic Arm|"Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
10940171|NCT00760006|OG001|Outcome|Saline Placebo Arm|"Other Names:~Salt solution~Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
10940172|NCT00760006|EG000|Reported Event|Unasyn Antibiotic Arm|"Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
10940173|NCT00760006|EG001|Reported Event|Saline Placebo Arm|"Other Names:~Salt solution~Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
10940174|NCT00760019|BG000|Baseline|Atherosclerosis or Metabolic Syndrome|"Participant flow is identical to that of NCT00762827 (The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome):~The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this arm, individuals with either Metabolic Syndrome or Atherosclerosis received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks."
10940175|NCT00760019|BG001|Baseline|Healthy|"Participant flow is identical to that of NCT00762827 (The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome):~The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this control arm, healthy individuals received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks."
10940176|NCT00760019|BG002|Baseline|Total|Total of all reporting groups
10940177|NCT00760019|FG000|Participant Flow|Atherosclerosis/Metabolic Syndrome: Salsalate First, Then Plac|Subjects with either Metabolic Syndrome/Atherosclerosis received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.
10940178|NCT00760019|FG001|Participant Flow|Atherosclerosis/Metabolic Syndrome: Placebo First, Then Salsal|Subjects with either Metabolic Syndrome/Atherosclerosis received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
10940179|NCT00760019|FG002|Participant Flow|Healthy Subjects: Salsalate First, Then Placebo|Healthy subjects received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.
10940180|NCT00760019|FG003|Participant Flow|Healthy Subjects: Placebo First, Then Salsalate|Healthy subjects received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
10940181|NCT00760019|OG000|Outcome|Salsalate|Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
10940182|NCT00760019|OG001|Outcome|Placebo|Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
10940183|NCT00760019|EG000|Reported Event|Salsalate|Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Salsalate
10940184|NCT00760019|EG001|Reported Event|Placebo|Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Placebo
10940185|NCT00760084|BG000|Baseline|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
10940186|NCT00760084|FG000|Participant Flow|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
10940187|NCT00760084|OG000|Outcome|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
10940188|NCT00760084|EG000|Reported Event|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
10940189|NCT00760214|BG000|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
10940190|NCT00760214|BG001|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
10940191|NCT00760214|BG002|Baseline|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
10940192|NCT00760214|BG003|Baseline|Total|Total of all reporting groups
10940193|NCT00760214|FG000|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
10940194|NCT00760214|FG001|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
10940195|NCT00760214|FG002|Participant Flow|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
10940196|NCT00760214|OG000|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
10940197|NCT00760214|OG001|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
10940198|NCT00760214|OG002|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
10940199|NCT00760214|EG000|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
10940200|NCT00760214|EG001|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
10940201|NCT00760214|EG002|Reported Event|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
10940202|NCT00760266|BG000|Baseline|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
10940203|NCT00760266|BG001|Baseline|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
10940204|NCT00760266|BG002|Baseline|Total|Total of all reporting groups
10940205|NCT00760266|FG000|Participant Flow|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
10940206|NCT00760266|FG001|Participant Flow|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
10940207|NCT00760266|OG000|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
10940208|NCT00760266|OG001|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
10940209|NCT00760266|EG000|Reported Event|Aliskiren / HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week, Aliskiren HCTZ 300/25 mg (with or without amlodipine): 7 weeks
10940210|NCT00760266|EG001|Reported Event|HCTZ|HCTZ 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
10940211|NCT00760383|BG000|Baseline|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
10940212|NCT00760383|BG001|Baseline|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
10940213|NCT00760383|BG002|Baseline|Total|Total of all reporting groups
10940214|NCT00760383|FG000|Participant Flow|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
10940215|NCT00760383|FG001|Participant Flow|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
10940216|NCT00760383|OG000|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
10940217|NCT00760383|OG001|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
10940218|NCT00760383|EG000|Reported Event|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
10940219|NCT00760383|EG001|Reported Event|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
10940220|NCT00760435|BG000|Baseline|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
10940221|NCT00760435|BG001|Baseline|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
11177018|NCT02038907|EG004|Reported Event|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
10940222|NCT00760435|BG002|Baseline|Total|Total of all reporting groups
10940223|NCT00760435|FG000|Participant Flow|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
10940224|NCT00760435|FG001|Participant Flow|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
10940225|NCT00760435|OG000|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
10940226|NCT00760435|OG001|Outcome|Placebo|97 subjects who received placebo + IVIG
10940227|NCT00760435|EG000|Reported Event|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
10940228|NCT00760435|EG001|Reported Event|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
10940229|NCT00760474|BG000|Baseline|Entire Study Population|"Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence to receive either:~Pregabalin, then placebo: Pregabalin 75 mg PO BID Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38 and included dose escalation through Day 51 followed by placebo taper Day 52 to 58.~Or placebo, then Pregabalin: Placebo matching study treatment was administered in a similar fashion to Pregabalin treatment beginning Period 1/Day 9 and included dose escalation, taper and an 8-day placebo washout period. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58."
11177019|NCT02038907|EG005|Reported Event|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
10940230|NCT00760474|FG000|Participant Flow|Pregabalin First, Then Placebo|Pregabalin 75 milligrams (mg) by mouth (PO) twice daily (BID) Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38.
10940231|NCT00760474|FG001|Participant Flow|Placebo First, Then Pregabalin|Placebo matching study treatment was administered beginning Period 1/Day9. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.
10940232|NCT00760474|OG000|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
10940233|NCT00760474|OG001|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
10940234|NCT00760474|OG000|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.~Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
10940235|NCT00760474|EG000|Reported Event|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
10940236|NCT00760474|EG001|Reported Event|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
10940237|NCT00760487|BG000|Baseline|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
10940238|NCT00760487|FG000|Participant Flow|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
10940239|NCT00760487|OG000|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
10940240|NCT00760487|EG000|Reported Event|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
10940241|NCT00760513|BG000|Baseline|Omega 3 Fatty Acid (Fish Oil)|OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
10940242|NCT00760513|BG001|Baseline|Dummy Pill|4 grammes daily, oral capsule (olive oil)
10940243|NCT00760513|BG002|Baseline|Total|Total of all reporting groups
10940244|NCT00760513|FG000|Participant Flow|Omega 3 Fatty Acid (Fish Oil)|"OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule~OMACOR: 4 grammes daily, oral capsule"
10940245|NCT00760513|FG001|Participant Flow|Dummy Pill|4 grammes daily, oral capsule (olive oil)
10940246|NCT00760513|OG000|Outcome|Omega 3 Fatty Acid (Fish Oil)|OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
10940247|NCT00760513|OG001|Outcome|Dummy Pill|4 grammes daily, oral capsule (olive oil)
10940248|NCT00760513|OG000|Outcome|Omega 3 Fatty Acid (Fish Oil)|"OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule~OMACOR: 4 grammes daily, oral capsule"
10940249|NCT00760513|OG001|Outcome|Dummy Pill|"4 grammes daily, oral capsule (olive oil)~Placebo oral capsule: 4 grammes daily, oral capsule (olive oil)"
10940250|NCT00760513|EG000|Reported Event|Omega 3 Fatty Acid (Fish Oil)|"OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule~OMACOR: 4 grammes daily, oral capsule"
10940251|NCT00760513|EG001|Reported Event|Dummy Pill|"4 grammes daily, oral capsule (olive oil)~OMACOR: 4 grammes daily, oral capsule"
10940252|NCT00760526|BG000|Baseline|Continuous Glucose Montoring|Treatment group
11177020|NCT02038907|EG006|Reported Event|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
10940253|NCT00760526|BG001|Baseline|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
10940254|NCT00760526|BG002|Baseline|Total|Total of all reporting groups
10940255|NCT00760526|FG000|Participant Flow|Continuous Glucose Montoring|Participants randomized to the CGM (treatment) group were provided with an unblinded CGM device, sensors, and a FreeStyle Flash blood glucose meter and test strips. A Free- Style Navigator was provided unless the participant was already using a Medtronic Paradigm insulin pump, in which case a MiniMed MiniLink REAL-Time Transmitter could be used. Parents were instructed on device use and daily sensor use was encouraged. They were instructed to continue testing with the home blood glucose meter >=4 times/day and to verify the accuracy of the CGM glucose measurement with the meter before making management decisions. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
10940256|NCT00760526|FG001|Participant Flow|Standard Glucose Monitoring With Home Glucose Meter|Participants in the control group were given a FreeStyle Flash blood glucose meter and test strips and asked to perform blood glucose monitoring at least four times daily. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
10940257|NCT00760526|OG000|Outcome|Continuous Glucose Montoring|Treatment group
10940258|NCT00760526|OG001|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
10940259|NCT00760526|OG000|Outcome|Continuous Glucose Montoring|Treatment group: Hypoglycemia Fear Survey
10940260|NCT00760526|OG001|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Hypoglycemia Fear Survey
10940261|NCT00760526|OG000|Outcome|Continuous Glucose Montoring|Treatment group: PAID
10940262|NCT00760526|OG001|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: PAID
10940263|NCT00760526|OG000|Outcome|Continuous Glucose Montoring|Treatment group: Blood Glucose Monitoring System Rating Scale
10940264|NCT00760526|OG001|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Blood Glucose Monitoring System Rating Scale
10940265|NCT00760526|OG000|Outcome|Continuous Glucose Montoring|Treatment group: CGM Satisfaction
10940266|NCT00760526|EG000|Reported Event|Continuous Glucose Montoring|Treatment group
10940267|NCT00760526|EG001|Reported Event|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
11177021|NCT02038907|EG007|Reported Event|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
10940268|NCT00760552|BG000|Baseline|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
10940269|NCT00760552|BG001|Baseline|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
10940270|NCT00760552|BG002|Baseline|Total|Total of all reporting groups
10940271|NCT00760552|FG000|Participant Flow|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
10940272|NCT00760552|FG001|Participant Flow|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
10940273|NCT00760552|OG000|Outcome|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
10940274|NCT00760552|OG001|Outcome|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
10940275|NCT00760552|EG000|Reported Event|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
10940276|NCT00760552|EG001|Reported Event|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
10940277|NCT00760578|BG000|Baseline|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
10940278|NCT00760578|BG001|Baseline|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
10940279|NCT00760578|BG002|Baseline|Pioglitazone|Pioglitazone 45 mg once daily
10940280|NCT00760578|BG003|Baseline|Placebo|Microcrystaline cellulose once daily
10940281|NCT00760578|BG004|Baseline|Total|Total of all reporting groups
10940282|NCT00760578|FG000|Participant Flow|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
10940283|NCT00760578|FG001|Participant Flow|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
10940284|NCT00760578|FG002|Participant Flow|Pioglitazone|Pioglitazone 45 mg once daily
10940285|NCT00760578|FG003|Participant Flow|Placebo|Microcrystaline cellulose once daily
10940286|NCT00760578|OG000|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
10940287|NCT00760578|OG001|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
10940288|NCT00760578|OG002|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
10940289|NCT00760578|OG003|Outcome|Placebo|Placebo (microcrystalline cellulose) taken once daily for 28 days
10940290|NCT00760578|OG003|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
10940291|NCT00760578|OG000|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
10940292|NCT00760578|OG001|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
10940293|NCT00760578|OG002|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
10940294|NCT00760578|OG003|Outcome|Placebo|Microcrystaline cellulose once daily
10940295|NCT00760578|EG000|Reported Event|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
10940296|NCT00760578|EG001|Reported Event|Placebo|Microcrystaline cellulose once daily
10940297|NCT00760578|EG002|Reported Event|Pioglitazone|Pioglitazone 45 mg once daily
10940298|NCT00760578|EG003|Reported Event|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
10940299|NCT00760617|BG000|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
10940300|NCT00760617|BG001|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
10940301|NCT00760617|BG002|Baseline|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
10940302|NCT00760617|BG003|Baseline|Total|Total of all reporting groups
10940303|NCT00760617|FG000|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
10940304|NCT00760617|FG001|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
10940305|NCT00760617|FG002|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
10940306|NCT00760617|OG000|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
10940307|NCT00760617|OG001|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
10940308|NCT00760617|OG002|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
10940309|NCT00760617|EG000|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
10940310|NCT00760617|EG001|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
10940311|NCT00760617|EG002|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
10940312|NCT00760669|BG000|Baseline|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
10940313|NCT00760669|FG000|Participant Flow|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
10940314|NCT00760669|OG000|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
10940315|NCT00760669|EG000|Reported Event|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
10940316|NCT00760747|BG000|Baseline|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
10940317|NCT00760747|BG001|Baseline|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
10940318|NCT00760747|BG002|Baseline|Total|Total of all reporting groups
10940319|NCT00760747|FG000|Participant Flow|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
10940320|NCT00760747|FG001|Participant Flow|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
10940321|NCT00760747|OG000|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
10940322|NCT00760747|OG001|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
10940323|NCT00760747|EG000|Reported Event|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
11234284|NCT02433379|OG001|Outcome|S-ICD (EMBLEM Model A219)|"The first 200 subjects implanted with an EMBLEM S-ICD (Model A219) S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.~EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp"
10940324|NCT00760747|EG001|Reported Event|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
10940325|NCT00760838|BG000|Baseline|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
10940326|NCT00760838|BG001|Baseline|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
10940327|NCT00760838|BG002|Baseline|Total|Total of all reporting groups
10940328|NCT00760838|FG000|Participant Flow|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
10940329|NCT00760838|FG001|Participant Flow|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
10940330|NCT00760838|OG000|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
10940331|NCT00760838|OG001|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
10940332|NCT00760838|EG000|Reported Event|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
10940333|NCT00760838|EG001|Reported Event|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
11177022|NCT02038907|EG008|Reported Event|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
11177023|NCT02038907|EG009|Reported Event|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
10940334|NCT00760877|BG000|Baseline|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
10940335|NCT00760877|BG001|Baseline|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
10940336|NCT00760877|BG002|Baseline|Total|Total of all reporting groups
10940337|NCT00760877|FG000|Participant Flow|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
10940338|NCT00760877|FG001|Participant Flow|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
10940339|NCT00760877|OG000|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
10940340|NCT00760877|OG001|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
10940341|NCT00760877|EG000|Reported Event|Nilotinib|Nilotinib
10940342|NCT00760877|EG001|Reported Event|Imatinib|Imatinib
10940343|NCT00760877|EG002|Reported Event|Imatinib Subset That Crossed Over to Nilotinib|Imatinib subset that crossed over to nilotinib
10940344|NCT00760929|BG000|Baseline|Placebo for R1507 (9mg/kg iv)|Participants received a placebo equivalent to R1507 (9mg/kg iv) intravenously every week until disease progression.
10940345|NCT00760929|BG001|Baseline|Placebo for R1507 (16mg/kg iv)|Participants received the placebo equivalent to R1507 (16 mg/kg iv) intravenously every 3 weeks until disease progression.
10940346|NCT00760929|BG002|Baseline|R1507 (9mg/kg iv)|Participants received R1507 (9mg/kg iv) intravenously every week until disease progression.
10940347|NCT00760929|BG003|Baseline|R1507 (16mg/kg iv)|Participants received R1507 (16 mg/kg iv) intravenously every 3 weeks until disease progression.
10940348|NCT00760929|BG004|Baseline|Total|Total of all reporting groups
10940349|NCT00760929|FG000|Participant Flow|Placebo for R1507 (9mg/kg iv)|Participants received a placebo equivalent to R1507 (9mg/kg iv) intravenously every week until disease progression.
11177024|NCT02038907|EG010|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
11177025|NCT02038907|EG011|Reported Event|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
10940350|NCT00760929|FG001|Participant Flow|Placebo for R1507 (16mg/kg iv)|Participants received the placebo equivalent to R1507 (16 mg/kg iv) intravenously every 3 weeks until disease progression.
10940351|NCT00760929|FG002|Participant Flow|R1507 (9mg/kg iv)|Participants received R1507 (9mg/kg iv) intravenously every week until disease progression.
10940352|NCT00760929|FG003|Participant Flow|R1507 (16mg/kg iv)|Participants received R1507 (16 mg/kg iv) intravenously every 3 weeks until disease progression.
10940353|NCT00760929|OG000|Outcome|Placebo|Participants received a placebo equivalent to R1507 (9mg/kg iv) intravenously every week until disease progression or the placebo equivalent to R1507 (16 mg/kg iv) intravenously every 3 weeks until disease progression.
10940354|NCT00760929|OG001|Outcome|R1507 (9mg/kg iv)|Participants received R1507 (9mg/kg iv) intravenously every week until disease progression.
10940355|NCT00760929|OG002|Outcome|R1507 (16mg/kg iv)|Participants received R1507 (16 mg/kg iv) intravenously every 3 weeks until disease progression.
10940356|NCT00760929|EG000|Reported Event|Placebo for R1507 (9mg/kg iv)|Participants received a placebo equivalent to R1507 (9mg/kg iv) intravenously every week until disease progression.
10940357|NCT00760929|EG001|Reported Event|Placebo for R1507 (16mg/kg iv)|Participants received the placebo equivalent to R1507 (16 mg/kg iv) intravenously every 3 weeks until disease progression.
10940358|NCT00760929|EG002|Reported Event|R1507 (9mg/kg iv)|Participants received R1507 (9mg/kg iv) intravenously every week until disease progression.
10940359|NCT00760929|EG003|Reported Event|R1507 (16mg/kg iv)|Participants received R1507 (16 mg/kg iv) intravenously every 3 weeks until disease progression.
10940360|NCT00760994|BG000|Baseline|1 - Experiential Accepatance (EA)|"Experiential acceptance~Experiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004)."
10940361|NCT00760994|BG001|Baseline|2 - Cognitive Restructuring (CR)|"Cognitive restructuring~Cognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."
11177026|NCT02038907|EG012|Reported Event|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11177027|NCT02038907|EG013|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
11177028|NCT02038920|BG000|Baseline|Induction Phase: Vedolizumab, 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177029|NCT02038920|BG001|Baseline|Induction Phase: Placebo|Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
11177030|NCT02038920|BG002|Baseline|Total|Total of all reporting groups
11177031|NCT02038920|FG000|Participant Flow|Induction Phase: Vedolizumab, 300 mg|Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177032|NCT02038920|FG001|Participant Flow|Induction Phase: Placebo|Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
10940362|NCT00760994|BG002|Baseline|3 - Control|"No-intervention control: Nutrition information~No-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant."
10940363|NCT00760994|BG003|Baseline|Total|Total of all reporting groups
10940364|NCT00760994|FG000|Participant Flow|1 - Experiential Accepatance (EA)|"Experiential acceptance~Experiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004)."
10940365|NCT00760994|FG001|Participant Flow|2 - Cognitive Restructuring (CR)|"Cognitive restructuring~Cognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."
10940366|NCT00760994|FG002|Participant Flow|3 - Control|"No-intervention control: Nutrition information~No-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant."
10940367|NCT00760994|OG000|Outcome|1 - Experiential Accepatance|"Experiential acceptance~Experiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004)."
10940368|NCT00760994|OG001|Outcome|2 - Cognitive Restructuring|"Cognitive restructuring~Cognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."
10940369|NCT00760994|OG002|Outcome|3 - Control|"No-intervention control: Nutrition information~No-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant."
10940370|NCT00760994|OG000|Outcome|1 - Experiential Accepatance (EA)|"Experiential acceptance~Experiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004)."
10940371|NCT00760994|OG001|Outcome|2 - Cognitive Restructuring (CR)|"Cognitive restructuring~Cognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."
10940372|NCT00760994|EG000|Reported Event|1 - Experiential Accepatance (EA)|"Experiential acceptance~Experiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004)."
10940373|NCT00760994|EG001|Reported Event|2 - Cognitive Restructuring (CR)|"Cognitive restructuring~Cognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."
10940374|NCT00760994|EG002|Reported Event|3 - Control|"No-intervention control: Nutrition information~No-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant."
10940375|NCT00761007|BG000|Baseline|Ibodutant 10 mg|oral tablet, once daily
10940376|NCT00761007|BG001|Baseline|Ibodutant 30 mg|oral tablet, once daily
10940377|NCT00761007|BG002|Baseline|Ibodutant 60 mg|oral tablet, once daily
10940378|NCT00761007|BG003|Baseline|Placebo|oral tablet, once daily
10940379|NCT00761007|BG004|Baseline|Total|Total of all reporting groups
10940380|NCT00761007|FG000|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
10940381|NCT00761007|FG001|Participant Flow|Ibodutant 30 mg|oral tablet, once daily
10940382|NCT00761007|FG002|Participant Flow|Ibodutant 60 mg|oral tablet, once daily
10940383|NCT00761007|FG003|Participant Flow|Placebo|oral tablet, once daily
10940384|NCT00761007|OG000|Outcome|Ibodutant 10 mg|oral tablet, once daily
10940385|NCT00761007|OG001|Outcome|Ibodutant 30 mg|oral tablet, once daily
10940386|NCT00761007|OG002|Outcome|Ibodutant 60 mg|oral tablet, once daily
10940387|NCT00761007|OG003|Outcome|Placebo|oral tablet, once daily
10940388|NCT00761007|EG000|Reported Event|Ibodutant 10 mg|oral tablet, once daily
10940389|NCT00761007|EG001|Reported Event|Ibodutant 30 mg|oral tablet, once daily
10940390|NCT00761007|EG002|Reported Event|Ibodutant 60 mg|oral tablet, once daily
10940391|NCT00761007|EG003|Reported Event|Placebo|oral tablet, once daily
10940392|NCT00761085|BG000|Baseline|Methadone-Children|"Methadone comparison to standard of care for pain management~Methadone: Compare to standard of care for pain management of acute episode of pain"
10940393|NCT00761085|BG001|Baseline|Morphine-Children|"Morphine standard of Care pain management~Morphine: Standard of care for pain management of acute episode of pain"
11177033|NCT02038920|FG002|Participant Flow|Maintenance Phase: Vedolizumab 300 mg|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
11177034|NCT02038920|FG003|Participant Flow|Maintenance Phase: Placebo|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
10940394|NCT00761085|BG002|Baseline|Methadone-Adults|"Methadone comparison to standard of care for pain management~Methadone: Compare to standard of care for pain management of acute episode of pain"
10940395|NCT00761085|BG003|Baseline|Morphine-Adults|"Morphine standard of Care pain management~Morphine: Standard of care for pain management of acute episode of pain"
10940396|NCT00761085|BG004|Baseline|Total|Total of all reporting groups
10940397|NCT00761085|FG000|Participant Flow|Methadone-Children|"Methadone comparison to standard of care for pain management~Methadone: Compare to standard of care for pain management of acute episode of pain"
10940398|NCT00761085|FG001|Participant Flow|Morphine-Children|"Morphine standard of Care pain management~Morphine: Standard of care for pain management of acute episode of pain"
11234285|NCT02433379|EG000|Reported Event|S-ICD|"Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.~EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp"
11234286|NCT02433483|BG000|Baseline|Myeloid Malignancies|"Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.~Participants with CNS disease receive weekly age-adjusted intrathecal triples therapy until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).~Interventions:~Cycle 1: cytarabine, HPC-A donor infusion~Cycle 2: Participants who have at least a partial response to Cycle 1 are eligible to receive Cycle 2: cytarabine, HPC-A infusion~Cytarabine: Given by either intrathecal (IT) or intravenous (IV) route.~Intrathecal Triples: given IT.~HPC-A: Given IV."
11234287|NCT02433483|FG000|Participant Flow|Myeloid Malignancies|"Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.~Participants with CNS disease receive weekly age-adjusted intrathecal triples therapy until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).~Interventions:~Cycle 1: cytarabine, HPC-A donor infusion~Cycle 2: Participants who have at least a partial response to Cycle 1 are eligible to receive Cycle 2: cytarabine, HPC-A infusion~Cytarabine: Given by either intrathecal (IT) or intravenous (IV) route.~Intrathecal Triples: given IT.~HPC-A: Given IV."
11234288|NCT02433483|OG000|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
11234289|NCT02433483|EG000|Reported Event|Myeloid Malignancies|"Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.~Participants with CNS disease receive weekly age-adjusted intrathecal triples therapy until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).~Interventions:~Cycle 1: cytarabine, HPC-A donor infusion~Cycle 2: Participants who have at least a partial response to Cycle 1 are eligible to receive Cycle 2: cytarabine, HPC-A infusion~Cytarabine: Given by either intrathecal (IT) or intravenous (IV) route.~Intrathecal Triples: given IT.~HPC-A: Given IV."
11234290|NCT02433496|BG000|Baseline|Physician Coaching|"This group included 4 intervention primary care clinics that received an organizational coaching intervention that included in-person site visits and phone/email communication. Each participating clinic was designated one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit, a follow-up site visit, and communicating with the coach throughout the 6-month follow-up period.~Physician coaching: The coach presented the latest research on the benefits and risks of long-term opioid use. The coach helped the clinic team flowchart clinical workflows and determined the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.~The coach helped the team implement ideas using Plan-Do-Study-Act change cycles and maintained contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice."
11234291|NCT02433496|BG001|Baseline|Control Group|This group included 4 control primary care clinics that did not receive any intervention. A de-identified dataset was created to examine differences in outcome variables between intervention and control clinics.
11234292|NCT02433496|BG002|Baseline|Refused Group|This group included 3 primary care clinics that were approached to participate in the study, but refused to participate.
11234293|NCT02433496|BG003|Baseline|Total|Total of all reporting groups
10940399|NCT00761085|FG002|Participant Flow|Methadone-Adults|"Methadone comparison to standard of care for pain management~Methadone: Compare to standard of care for pain management of acute episode of pain"
10940400|NCT00761085|FG003|Participant Flow|Morphine-Adults|"Morphine standard of Care pain management~Morphine: Standard of care for pain management of acute episode of pain"
10940401|NCT00761085|OG000|Outcome|Methadone-Children|"Methadone comparison to standard of care for pain management~Methadone: Compare to standard of care for pain management of acute episode of pain"
10940402|NCT00761085|OG001|Outcome|Morphine-Children|"Morphine standard of Care pain management~Morphine: Standard of care for pain management of acute episode of pain"
10940403|NCT00761085|OG002|Outcome|Methadone-Adults|"Methadone comparison to standard of care for pain management~Methadone: Compare to standard of care for pain management of acute episode of pain"
10940404|NCT00761085|OG003|Outcome|Morphine-Adults|"Morphine standard of Care pain management~Morphine: Standard of care for pain management of acute episode of pain"
10940405|NCT00761085|EG000|Reported Event|Methadone-Children|"Methadone comparison to standard of care for pain management~Methadone: Compare to standard of care for pain management of acute episode of pain"
10940406|NCT00761085|EG001|Reported Event|Morphine-Children|"Morphine standard of Care pain management~Morphine: Standard of care for pain management of acute episode of pain"
10940407|NCT00761085|EG002|Reported Event|Methadone-Adults|"Methadone comparison to standard of care for pain management~Methadone: Compare to standard of care for pain management of acute episode of pain"
10940408|NCT00761085|EG003|Reported Event|Morphine-Adults|"Morphine standard of Care pain management~Morphine: Standard of care for pain management of acute episode of pain"
10940409|NCT00761137|BG000|Baseline|All Study Participants|This study was a double-blind, randomized, placebo controlled, two-phased, Latin-square crossover study. Subjects received three single-doses of tropicamide or placebo in random order, with a 7-day washout period.
10940410|NCT00761137|FG000|Participant Flow|All Participants|subjects randomly received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
10940411|NCT00761137|OG000|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
10940412|NCT00761137|OG001|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
10940413|NCT00761137|OG002|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
10940414|NCT00761137|OG003|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
10940415|NCT00761137|EG000|Reported Event|All Participants|subjects received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
10940416|NCT00761150|BG000|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
10940417|NCT00761150|BG001|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
10940418|NCT00761150|BG002|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
10940419|NCT00761150|BG003|Baseline|Total|Total of all reporting groups
10940420|NCT00761150|FG000|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
10940421|NCT00761150|FG001|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
10940422|NCT00761150|FG002|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
10940423|NCT00761150|OG000|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
10940424|NCT00761150|OG001|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
10940425|NCT00761150|EG000|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
10940426|NCT00761150|EG001|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
11177035|NCT02038920|FG004|Participant Flow|Maintenance Phase: Placebo Continuation|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
11177036|NCT02038920|FG005|Participant Flow|Open-Label: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
11177037|NCT02038920|OG000|Outcome|Induction Phase: Vedolizumab, 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
10940427|NCT00761150|EG002|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
10940428|NCT00761189|BG000|Baseline|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
10940429|NCT00761189|FG000|Participant Flow|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
10940430|NCT00761189|OG000|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
10940431|NCT00761189|EG000|Reported Event|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
10940432|NCT00761202|BG000|Baseline|Carboxymethylcellulose and Glycerin|
10940433|NCT00761202|BG001|Baseline|Sodium Hyaluronate|
10940434|NCT00761202|BG002|Baseline|Total|Total of all reporting groups
10940435|NCT00761202|FG000|Participant Flow|Carboxymethylcellulose and Glycerin|
10940436|NCT00761202|FG001|Participant Flow|Sodium Hyaluronate|
10940437|NCT00761202|OG000|Outcome|Carboxymethylcellulose and Glycerin|
10940438|NCT00761202|OG001|Outcome|Sodium Hyaluronate|
10940439|NCT00761202|EG000|Reported Event|Carboxymethylcellulose and Glycerin|
10940440|NCT00761202|EG001|Reported Event|Sodium Hyaluronate|
10940441|NCT00761215|BG000|Baseline|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
10940442|NCT00761215|BG001|Baseline|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
10940443|NCT00761215|BG002|Baseline|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
10940444|NCT00761215|BG003|Baseline|Total|Total of all reporting groups
10940445|NCT00761215|FG000|Participant Flow|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
10940446|NCT00761215|FG001|Participant Flow|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
10940447|NCT00761215|FG002|Participant Flow|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
10940448|NCT00761215|OG000|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
10940449|NCT00761215|OG001|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
10940450|NCT00761215|OG002|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
10940451|NCT00761215|OG000|Outcome|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
10940452|NCT00761215|OG001|Outcome|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
10940453|NCT00761215|OG002|Outcome|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
10940454|NCT00761215|EG000|Reported Event|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
10940455|NCT00761215|EG001|Reported Event|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
10940456|NCT00761215|EG002|Reported Event|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
11177038|NCT02038920|OG001|Outcome|Induction Phase: Placebo|Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
11192164|NCT02137499|OG003|Outcome|Deep Venous Obstruction|Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
11192165|NCT02137499|EG000|Reported Event|Healthy Subjects|Healthy participants treated with Small transcutaneous electrical stimulator
10940457|NCT00761267|BG000|Baseline|Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years|Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.
10940458|NCT00761267|BG001|Baseline|Anidulafungin: Participants Aged 2 to <5 Years|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.
10940459|NCT00761267|BG002|Baseline|Anidulafungin: Participants Aged 5 to <18 Years|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.
10940460|NCT00761267|BG003|Baseline|Total|Total of all reporting groups
10940461|NCT00761267|FG000|Participant Flow|Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years|Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.
11177039|NCT02038920|OG000|Outcome|Maintenance Phase: Vedolizumab 300 mg|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
11177040|NCT02038920|OG001|Outcome|Maintenance Phase: Placebo|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
11177041|NCT02038920|OG002|Outcome|Maintenance Phase: Vedolizumab 300 mg|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
11177042|NCT02038920|OG003|Outcome|Maintenance Phase: Placebo|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
11177043|NCT02038920|OG004|Outcome|Maintenance Phase: Placebo Continuation|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
11177044|NCT02038920|OG005|Outcome|Open-Label: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
11177045|NCT02038920|OG000|Outcome|Open-Label: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
11177046|NCT02038920|EG000|Reported Event|Induction Phase: Vedolizumab, 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177047|NCT02038920|EG001|Reported Event|Induction Phase: Placebo|Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
11177048|NCT02038920|EG002|Reported Event|Maintenance Phase: Vedolizumab 300 mg|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
11177049|NCT02038920|EG003|Reported Event|Maintenance Phase: Placebo|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
11192166|NCT02137499|EG001|Reported Event|Superficial Venous Insufficiency|Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator
10940462|NCT00761267|FG001|Participant Flow|Anidulafungin: Participants Aged 2 to <5 Years|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.
10940463|NCT00761267|FG002|Participant Flow|Anidulafungin: Participants Aged 5 to <18 Years|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.
10940464|NCT00761267|OG000|Outcome|Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years|Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.
10940465|NCT00761267|OG001|Outcome|Anidulafungin: Participants Aged 2 to <5 Years|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.
10940466|NCT00761267|OG002|Outcome|Anidulafungin: Participants Aged 5 to <18 Years|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.
10940467|NCT00761267|OG000|Outcome|Anidulafungin PK Subgroup of First 6: 1 Month to <2 Years|First 6 participants received Anidulafungin at loading dose of 3 mg/kg, IV on Day 1, then maintenance dose of 1.5 mg/kg, every 24 hours for minimum of 10 days and maximum of 35 days. After >=10 days of IV treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criterion [1) afebrile for >=24 hours, 2) tolerate oral medication, 3)documentation of 2 blood cultures (24 hours apart) negative for Candida species,4) Eradication/presumed eradication of Candida species from any other sites of infection if identified at enrollment, 5) Specific Candida isolate was susceptible/presumed susceptible to fluconazole, 6) switched to oral fluconazole if improvement in signs, symptoms of Candida infection] received oral fluconazole (6 to 12 mg/kg/day, maximum 800 mg/day) up to 49 days. Participants received a second systemic antifungal agent, if required at the Investigator's discretion.
10940468|NCT00761267|OG000|Outcome|Anidulafungin PK Subgroup of Last Eight: 1 Month to <2 Years|Last eight participants received Anidulafungin loading dose of 3 mg/kg, IV on Day 1, then maintenance dose of 1.5 mg/kg, every 24 hours for minimum of 10 days and maximum of 35 days. After >=10 days of IV treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criterion [1) afebrile for >=24 hours, 2) tolerate oral medication, 3)documentation of 2 blood cultures (24 hours apart) negative for Candida species,4) Eradication/presumed eradication of Candida species from any other sites of infection if identified at enrollment, 5) Specific Candida isolate was susceptible/presumed susceptible to fluconazole, 6) switched to oral fluconazole if improvement in signs, symptoms of Candida infection] received oral fluconazole (6 to 12 mg/kg/day, maximum 800 mg/day) up to 49 days. Participants received a second systemic antifungal agent, if required at the Investigator's discretion.
10940469|NCT00761267|OG000|Outcome|AUC0-24ss (0-61 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss in the range of 0 to 61 mcg*h/ml.
10940470|NCT00761267|OG001|Outcome|AUC0-24ss (>61-72 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 61 to 72 mcg*h/ml).
11192167|NCT02137499|EG002|Reported Event|Deep Venous Insufficiency|Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator
11192168|NCT02137499|EG003|Reported Event|Deep Venous Obstruction|Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
10940471|NCT00761267|OG002|Outcome|AUC0-24ss (>72-89 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 72 to 89 mcg*h/ml).
10940472|NCT00761267|OG003|Outcome|AUC0-24ss (>89-109 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg*h/ml).
10940473|NCT00761267|OG004|Outcome|AUC0-24ss (>109 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg*h/ml).
10940474|NCT00761267|OG001|Outcome|AUC0-24ss (>61-74 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 61 to 74 mcg*h/ml).
10940475|NCT00761267|OG002|Outcome|AUC0-24ss (>74-89 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 74 to 89 mcg*h/ml).
10940476|NCT00761267|OG003|Outcome|AUC0-24ss (>89-112 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 112 mcg*h/ml).
10940477|NCT00761267|OG004|Outcome|AUC0-24ss (>112 mcg*hr/ml)|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 112 mcg*h/ml).
10940478|NCT00761267|EG000|Reported Event|Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years|Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.
10940479|NCT00761267|EG001|Reported Event|Anidulafungin: Participants Aged 2 to <5 Years|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.
10940480|NCT00761267|EG002|Reported Event|Anidulafungin: Participants Aged 5 to <18 Years|Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.
10940481|NCT00761280|BG000|Baseline|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
10940482|NCT00761280|BG001|Baseline|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
11177050|NCT02038920|EG004|Reported Event|Maintenance Phase: Placebo Continuation|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
11177051|NCT02038920|EG005|Reported Event|Open-Label: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
11177052|NCT02038933|BG000|Baseline|ASCT-failed|Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
10940483|NCT00761280|BG002|Baseline|Total|Total of all reporting groups
11177053|NCT02038933|BG001|Baseline|ASCT-ineligible|Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
11177054|NCT02038933|BG002|Baseline|Total|Total of all reporting groups
11177055|NCT02038933|FG000|Participant Flow|Nivolumab 3mg/kg|Nivolumab 3mg/kg IV Q2W for participants who failed autologous stem cell transplant (ASCT) or who were ineligible for ASCT
11177056|NCT02038933|OG000|Outcome|ASCT-failed|Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
11177057|NCT02038933|OG001|Outcome|ASCT-ineligible|Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
10940484|NCT00761280|FG000|Participant Flow|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
10940485|NCT00761280|FG001|Participant Flow|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
10940486|NCT00761280|OG000|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
10940487|NCT00761280|OG001|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
10940488|NCT00761280|EG000|Reported Event|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
10940489|NCT00761280|EG001|Reported Event|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
10940490|NCT00761306|BG000|Baseline|Vortioxetine 5 or 10 mg/Day|tablets; orally
10940491|NCT00761306|FG000|Participant Flow|Vortioxetine 5 or 10 mg/Day|tablets; orally
10940492|NCT00761306|OG000|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
10940493|NCT00761306|EG000|Reported Event|Vortioxetine 5 or 10 mg/Day|
10940494|NCT00761319|BG000|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
10940495|NCT00761319|BG001|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
10940496|NCT00761319|BG002|Baseline|Total|Total of all reporting groups
10940497|NCT00761319|FG000|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
10940498|NCT00761319|FG001|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
10940499|NCT00761319|OG000|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
10940500|NCT00761319|OG001|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
10940501|NCT00761319|EG000|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
10940502|NCT00761319|EG001|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
10940503|NCT00761345|BG000|Baseline|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
11177058|NCT02038933|EG000|Reported Event|NIVOLUMAB 3 mg/kg|
11177059|NCT02038959|BG000|Baseline|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
11177060|NCT02038959|BG001|Baseline|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
11177061|NCT02038959|BG002|Baseline|Total|Total of all reporting groups
10940504|NCT00761345|FG000|Participant Flow|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
10940505|NCT00761345|OG000|Outcome|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
10940506|NCT00761345|EG000|Reported Event|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
10940507|NCT00761462|BG000|Baseline|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
10940508|NCT00761462|BG001|Baseline|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
11177062|NCT02038959|FG000|Participant Flow|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
11177063|NCT02038959|FG001|Participant Flow|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
11177064|NCT02038959|OG000|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
11177065|NCT02038959|OG001|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
11177066|NCT02038959|EG000|Reported Event|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
11177067|NCT02038959|EG001|Reported Event|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
10940509|NCT00761462|BG002|Baseline|Total|Total of all reporting groups
10940510|NCT00761462|FG000|Participant Flow|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
10940511|NCT00761462|FG001|Participant Flow|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
10940512|NCT00761462|OG000|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
10940513|NCT00761462|OG001|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
10940514|NCT00761462|EG000|Reported Event|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
10940515|NCT00761462|EG001|Reported Event|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
10940516|NCT00761514|BG000|Baseline|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
10940517|NCT00761514|FG000|Participant Flow|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
10940518|NCT00761514|OG000|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
10940519|NCT00761514|EG000|Reported Event|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
10940520|NCT00761579|BG000|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
10940521|NCT00761579|FG000|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
10940522|NCT00761579|OG000|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
10940523|NCT00761579|OG001|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
10940524|NCT00761579|OG002|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
10940525|NCT00761579|EG000|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
10940526|NCT00761592|BG000|Baseline|Botulinum Toxin Type A 900kDa|
10940527|NCT00761592|BG001|Baseline|Botulinum Toxin Type A 150kDa|
10940528|NCT00761592|BG002|Baseline|Total|Total of all reporting groups
10940529|NCT00761592|FG000|Participant Flow|Botulinum Toxin Type A 900kDa|
10940530|NCT00761592|FG001|Participant Flow|Botulinum Toxin Type A 150kDa|
10940531|NCT00761592|OG000|Outcome|Botulinum Toxin Type A 900kDa|
10940532|NCT00761592|OG001|Outcome|Botulinum Toxin Type A 150kDa|
10940533|NCT00761592|EG000|Reported Event|Botulinum Toxin Type A 900kDa|
10940534|NCT00761592|EG001|Reported Event|Botulinum Toxin Type A 150kDa|
10940535|NCT00761605|BG000|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
10940536|NCT00761605|FG000|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
10940537|NCT00761605|OG000|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
10940538|NCT00761605|OG001|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
10940539|NCT00761605|OG002|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
10940540|NCT00761605|OG000|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
10940541|NCT00761605|OG002|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
10940542|NCT00761605|EG000|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
10940543|NCT00761631|BG000|Baseline|13vPnC Group 1 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
10940544|NCT00761631|BG001|Baseline|13vPnC Group 2 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
10940545|NCT00761631|BG002|Baseline|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
10940546|NCT00761631|BG003|Baseline|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
10940547|NCT00761631|BG004|Baseline|Total|Total of all reporting groups
10940548|NCT00761631|FG000|Participant Flow|13vPnC Group 1 (Cohort 1)|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
10940549|NCT00761631|FG001|Participant Flow|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
10940550|NCT00761631|FG002|Participant Flow|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
10940551|NCT00761631|FG003|Participant Flow|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
10940552|NCT00761631|FG004|Participant Flow|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
10940553|NCT00761631|FG005|Participant Flow|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
10940554|NCT00761631|OG000|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
10940555|NCT00761631|OG001|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
10940556|NCT00761631|OG000|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
10940557|NCT00761631|OG001|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
10940558|NCT00761631|OG002|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
10940559|NCT00761631|OG003|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
10940560|NCT00761631|OG004|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
10940561|NCT00761631|OG005|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
10940562|NCT00761631|OG001|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
10940563|NCT00761631|EG000|Reported Event|13vPnC Group 1 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
10940564|NCT00761631|EG001|Reported Event|13vPnC Group 1 (Cohort 1) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
10940565|NCT00761631|EG002|Reported Event|13vPnC Group 2 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
10940566|NCT00761631|EG003|Reported Event|13vPnC Group 1 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
10940567|NCT00761631|EG004|Reported Event|13vPnC Group 1 (Cohort 2) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
10940568|NCT00761631|EG005|Reported Event|13vPnC Group 2 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
10940569|NCT00761631|EG006|Reported Event|6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 1 (Cohort 1 and 2).
10940570|NCT00761631|EG007|Reported Event|6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 2 (Cohort 1 and 2).
10940571|NCT00761631|EG008|Reported Event|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
10940572|NCT00761631|EG009|Reported Event|6-Month Follow-up 13vPnC Group 3|6-month follow-up telephone contact for participants in Group 3.
10940573|NCT00761631|EG010|Reported Event|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
10940574|NCT00761631|EG011|Reported Event|6-Month Follow-up 13vPnC Group 4|6 -Month Follow-up Telephone Contact for participants in Group 4.
10940575|NCT00761657|BG000|Baseline|Roxadustat 0.7 mg/kg BIW|Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940576|NCT00761657|BG001|Baseline|Roxadustat 0.7 mg/kg TIW|Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940577|NCT00761657|BG002|Baseline|Roxadustat 1.0 mg/kg BIW|Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.
10940578|NCT00761657|BG003|Baseline|Roxadustat 1.0 mg/kg TIW|Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.
10940579|NCT00761657|BG004|Baseline|Roxadustat 1.5 mg/kg BIW|Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940580|NCT00761657|BG005|Baseline|Roxadustat 1.5 mg/kg TIW|Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940581|NCT00761657|BG006|Baseline|Roxadustat 2.0 mg/kg BIW|Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940582|NCT00761657|BG007|Baseline|Roxadustat 2.0 mg/kg TIW|Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940583|NCT00761657|BG008|Baseline|Placebo|Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
10940584|NCT00761657|BG009|Baseline|Total|Total of all reporting groups
10940585|NCT00761657|FG000|Participant Flow|Roxadustat 0.7 Milligrams/Kilograms (mg/kg) BIW|Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940586|NCT00761657|FG001|Participant Flow|Roxadustat 0.7 mg/kg TIW|Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940587|NCT00761657|FG002|Participant Flow|Roxadustat 1.0 mg/kg BIW|Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.
10940588|NCT00761657|FG003|Participant Flow|Roxadustat 1.0 mg/kg TIW|Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.
10940589|NCT00761657|FG004|Participant Flow|Roxadustat 1.5 mg/kg BIW|Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940590|NCT00761657|FG005|Participant Flow|Roxadustat 1.5 mg/kg TIW|Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940591|NCT00761657|FG006|Participant Flow|Roxadustat 2.0 mg/kg BIW|Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940592|NCT00761657|FG007|Participant Flow|Roxadustat 2.0 mg/kg TIW|Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940593|NCT00761657|FG008|Participant Flow|Placebo|Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
10940594|NCT00761657|OG000|Outcome|Roxadustat 0.7 mg/kg BIW|Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940595|NCT00761657|OG001|Outcome|Roxadustat 0.7 mg/kg TIW|Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940596|NCT00761657|OG002|Outcome|Roxadustat 1.0 mg/kg BIW|Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.
10940597|NCT00761657|OG003|Outcome|Roxadustat 1.0 mg/kg TIW|Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.
10940598|NCT00761657|OG004|Outcome|Roxadustat 1.5 mg/kg BIW|Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940599|NCT00761657|OG005|Outcome|Roxadustat 1.5 mg/kg TIW|Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940600|NCT00761657|OG006|Outcome|Roxadustat 2.0 mg/kg BIW|Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940601|NCT00761657|OG007|Outcome|Roxadustat 2.0 mg/kg TIW|Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940602|NCT00761657|OG008|Outcome|Placebo|Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
10940603|NCT00761657|OG002|Outcome|Roxadustat 1.5 mg/kg BIW|Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940604|NCT00761657|OG003|Outcome|Roxadustat 1.5 mg/kg TIW|Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940605|NCT00761657|OG004|Outcome|Roxadustat 2.0 mg/kg BIW|Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940606|NCT00761657|OG005|Outcome|Roxadustat 2.0 mg/kg TIW|Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940607|NCT00761657|OG000|Outcome|Roxadustat 1.0 mg/kg BIW|Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.
10940608|NCT00761657|OG001|Outcome|Roxadustat 1.0 mg/kg TIW|Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.
10940609|NCT00761657|OG002|Outcome|Roxadustat 2.0 mg/kg BIW|Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940610|NCT00761657|OG003|Outcome|Roxadustat 2.0 mg/kg TIW|Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940611|NCT00761657|OG004|Outcome|Placebo|Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
10940612|NCT00761657|OG006|Outcome|Placebo|Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
10940613|NCT00761657|EG000|Reported Event|Roxadustat 0.7 mg/kg BIW|Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940614|NCT00761657|EG001|Reported Event|Roxadustat 0.7 mg/kg TIW|Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940615|NCT00761657|EG002|Reported Event|Roxadustat 1.0 mg/kg BIW|Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.
10940616|NCT00761657|EG003|Reported Event|Roxadustat 1.0 mg/kg TIW|Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.
10940617|NCT00761657|EG004|Reported Event|Roxadustat 1.5 mg/kg BIW|Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940618|NCT00761657|EG005|Reported Event|Roxadustat 1.5 mg/kg TIW|Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940619|NCT00761657|EG006|Reported Event|Roxadustat 2.0 mg/kg BIW|Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
10940620|NCT00761657|EG007|Reported Event|Roxadustat 2.0 mg/kg TIW|Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
10940621|NCT00761657|EG008|Reported Event|Placebo|Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
10940622|NCT00761735|BG000|Baseline|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
10940623|NCT00761735|FG000|Participant Flow|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
10940624|NCT00761735|OG000|Outcome|PEG-IFN + RBV: LTFU (All)|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
10940625|NCT00761735|OG000|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
10940626|NCT00761735|OG001|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
10940627|NCT00761735|OG000|Outcome|PEG-IFN + RBV: LTFU (Female)|Female pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
10940628|NCT00761735|OG001|Outcome|PEG-IFN + RBV: LTFU (Male)|Male pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
10940629|NCT00761735|EG000|Reported Event|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
10940630|NCT00761748|BG000|Baseline|Overall Study Population|Urostomy operated subjects
10940631|NCT00761748|FG000|Participant Flow|Sensura Uro 2 Piece First, Then Convatec 2 Piece|Sensura is a newly developed two piece product for people with urostomies.
10940632|NCT00761748|FG001|Participant Flow|ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece|Convatec is the reference product and was chosen because of its similarity with the Sensura appliance.
10940633|NCT00761748|OG000|Outcome|Sensura Uro 2 Piece|The new SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
10940634|NCT00761748|OG001|Outcome|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urin from a stoma.
10940635|NCT00761748|EG000|Reported Event|Sensura Uro 2 Piece|SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
10940636|NCT00761748|EG001|Reported Event|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urine from a stoma.
10940637|NCT00761761|BG000|Baseline|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940638|NCT00761761|BG001|Baseline|Placebo|"Placebo~Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week and will be continued for a total of 8 weeks."
10940639|NCT00761761|BG002|Baseline|Total|Total of all reporting groups
10940640|NCT00761761|FG000|Participant Flow|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940641|NCT00761761|FG001|Participant Flow|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940642|NCT00761761|OG000|Outcome|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940643|NCT00761761|OG001|Outcome|Placebo|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940644|NCT00761761|OG000|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940645|NCT00761761|OG001|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940646|NCT00761761|EG000|Reported Event|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940647|NCT00761761|EG001|Reported Event|Placebo|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
10940648|NCT00761774|BG000|Baseline|Brivaracetam|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
10940649|NCT00761774|FG000|Participant Flow|Brivaracetam|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
10940650|NCT00761774|OG000|Outcome|Brivaracetam (SS)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
10940651|NCT00761774|OG000|Outcome|Brivaracetam (SS)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200mg/day.
10940652|NCT00761774|OG000|Outcome|Brivaracetam (ES)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
10940653|NCT00761774|EG000|Reported Event|Brivaracetam (SS)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
10940654|NCT00761813|BG000|Baseline|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
10940655|NCT00761813|BG001|Baseline|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
10940656|NCT00761813|BG002|Baseline|Total|Total of all reporting groups
10940657|NCT00761813|FG000|Participant Flow|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
10940658|NCT00761813|FG001|Participant Flow|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
10940659|NCT00761813|OG000|Outcome|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
10940660|NCT00761813|OG001|Outcome|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
10940661|NCT00761813|EG000|Reported Event|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
10940662|NCT00761813|EG001|Reported Event|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
11341651|NCT03686033|FG005|Participant Flow|Sequence 6: E2082 25 mg + E2082 2.5 mg + Placebo + E2082 40 mg|Participants received, E2082 25 mg (Treatment C) tablet, orally, once on Day 1 in Treatment Period 1, followed by E2082 2.5 mg (Treatment B) tablet, orally, once on Day 1 in Treatment Period 2, followed by E2082-matched placebo (Treatment A) tablet, orally, once on Day 1 in Treatment Period 3, followed by E2082 40 mg tablet, orally, once on Day 1 in Treatment Period 4 (Open-label). A washout phase of at least 2 weeks was maintained between the treatment periods.
10940663|NCT00761865|BG000|Baseline|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
10940664|NCT00761865|BG001|Baseline|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
10940665|NCT00761865|BG002|Baseline|Total|Total of all reporting groups
10940666|NCT00761865|FG000|Participant Flow|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
10940667|NCT00761865|FG001|Participant Flow|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
10940668|NCT00761865|OG000|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
10940669|NCT00761865|OG001|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
10940670|NCT00761865|EG000|Reported Event|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
10940671|NCT00761865|EG001|Reported Event|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
10940672|NCT00761891|BG000|Baseline|Chewable Aspirin|"81 mg daily for 2 weeks~Chewable aspirin: chewable aspirin 81mg daily for 2 weeks"
10940673|NCT00761891|FG000|Participant Flow|Chewable Aspirin|"81 mg daily for 2 weeks~Chewable aspirin: chewable aspirin 81mg daily for 2 weeks"
10940674|NCT00761891|OG000|Outcome|Chewable Aspirin|81 mg daily for 2 weeks
10940675|NCT00761891|OG000|Outcome|Chewable Aspirin|81mg aspirin daily for 2 weeks
10940676|NCT00761891|EG000|Reported Event|Enteric-coated Aspirin|"81 mg daily for 2 weeks~Enteric-coated aspirin: enteric-coated aspirin 81mg daily for 2 weeks"
11341652|NCT03686033|OG000|Outcome|Treatment A: Placebo|Participants received, E2082-matched placebo tablet, orally, once on Day 1 as per assigned Treatment sequence in Treatment Period 1, 2, or 3.
11341653|NCT03686033|OG001|Outcome|Treatment B: E2082 2.5 mg|Participants received, E2082 2.5 mg tablet, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10940677|NCT00761930|BG000|Baseline|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
10940678|NCT00761930|BG001|Baseline|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
10940679|NCT00761930|BG002|Baseline|C - Experimental Toothpaste|fluoride/herbal toothpaste
10940680|NCT00761930|BG003|Baseline|Total|Total of all reporting groups
10940681|NCT00761930|FG000|Participant Flow|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
10940682|NCT00761930|FG001|Participant Flow|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
10940683|NCT00761930|FG002|Participant Flow|C - Experimental Toothpaste|fluoride/herbal toothpaste
10940684|NCT00761930|OG000|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
10940685|NCT00761930|OG001|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
10940686|NCT00761930|OG002|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
10940687|NCT00761930|EG000|Reported Event|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
10940688|NCT00761930|EG001|Reported Event|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
10940689|NCT00761930|EG002|Reported Event|C - Experimental Toothpaste|fluoride/herbal toothpaste
10940690|NCT00761956|BG000|Baseline|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
10940691|NCT00761956|BG001|Baseline|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
10940692|NCT00761956|BG002|Baseline|Total|Total of all reporting groups
10940693|NCT00761956|FG000|Participant Flow|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
10940694|NCT00761956|FG001|Participant Flow|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
10940695|NCT00761956|OG000|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
10940696|NCT00761956|OG001|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
10940697|NCT00761956|EG000|Reported Event|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
10940698|NCT00761956|EG001|Reported Event|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
10940699|NCT00761969|BG000|Baseline|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
10940700|NCT00761969|BG001|Baseline|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
10940701|NCT00761969|BG002|Baseline|Total|Total of all reporting groups
10940702|NCT00761969|FG000|Participant Flow|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
10940703|NCT00761969|FG001|Participant Flow|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
10940704|NCT00761969|OG000|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
10940705|NCT00761969|OG001|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
10940706|NCT00761969|EG000|Reported Event|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
10940707|NCT00761969|EG001|Reported Event|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
10940708|NCT00762021|BG000|Baseline|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
10940709|NCT00762021|BG001|Baseline|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
10940710|NCT00762021|BG002|Baseline|Total|Total of all reporting groups
11177068|NCT02039115|BG000|Baseline|Prednisone|"Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.~prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision."
10940711|NCT00762021|FG000|Participant Flow|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
10940712|NCT00762021|FG001|Participant Flow|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
10940713|NCT00762021|OG000|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
10940714|NCT00762021|OG001|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
10940715|NCT00762021|EG000|Reported Event|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
10940716|NCT00762021|EG001|Reported Event|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
10940717|NCT00762034|BG000|Baseline|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940718|NCT00762034|BG001|Baseline|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940719|NCT00762034|BG002|Baseline|Total|Total of all reporting groups
10940720|NCT00762034|FG000|Participant Flow|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940721|NCT00762034|FG001|Participant Flow|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940722|NCT00762034|OG000|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940723|NCT00762034|OG001|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940724|NCT00762034|OG000|Outcome|Pem/Carbo/Bev; Induction Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940725|NCT00762034|OG001|Outcome|Pem/Carbo/Bev; Maintenance Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940726|NCT00762034|OG002|Outcome|Pac/Carbo/Bev; Induction Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940727|NCT00762034|OG003|Outcome|Pac/Carbo/Bev; Maintenance Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
11177069|NCT02039115|BG001|Baseline|Placebo|"Placebo tablets will be taken in the same manner as the prednisone arm.~placebo: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision."
11177070|NCT02039115|BG002|Baseline|Total|Total of all reporting groups
11177071|NCT02039115|FG000|Participant Flow|Prednisone|"Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.~prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision."
10940728|NCT00762034|OG000|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev)followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
10940729|NCT00762034|OG000|Outcome|Pem or Pac Plus Carbo/Bev|"Participants who received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
10940730|NCT00762034|OG000|Outcome|TTF-1 Positive (H Score > 0)|"Participants who were TTF-1 Positive (H score > 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
10940731|NCT00762034|OG001|Outcome|TTF-1 Negative (H Score = 0)|"Participants who were TTF-1 Negative (H score = 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
10940732|NCT00762034|EG000|Reported Event|Pem/Carbo/Bev|"Induction:~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days~Maintenance:~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
10940733|NCT00762034|EG001|Reported Event|Pac/Carbo/Bev|"Induction:~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m ²) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days~Maintenance:~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
10940734|NCT00762073|BG000|Baseline|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
10940735|NCT00762073|BG001|Baseline|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
10940736|NCT00762073|BG002|Baseline|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
10940737|NCT00762073|BG003|Baseline|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
10940738|NCT00762073|BG004|Baseline|Total|Total of all reporting groups
10940739|NCT00762073|FG000|Participant Flow|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
10940740|NCT00762073|FG001|Participant Flow|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
10940741|NCT00762073|FG002|Participant Flow|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
10940742|NCT00762073|FG003|Participant Flow|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
10940743|NCT00762073|OG000|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
10940744|NCT00762073|OG001|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
10940745|NCT00762073|OG002|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
10940746|NCT00762073|OG003|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
10940747|NCT00762073|OG000|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
11177072|NCT02039115|FG001|Participant Flow|Placebo|"Placebo tablets will be taken in the same manner as the prednisone arm.~placebo: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision."
10940748|NCT00762073|OG001|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
10940749|NCT00762073|OG002|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
10940750|NCT00762073|OG003|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
10940751|NCT00762073|OG000|Outcome|0.35 mg Dose|Participants 2 to 9 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
10940752|NCT00762073|OG001|Outcome|0.50 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
10940753|NCT00762073|OG003|Outcome|2.0 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
10940754|NCT00762073|EG000|Reported Event|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
10940755|NCT00762073|EG001|Reported Event|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
10940756|NCT00762073|EG002|Reported Event|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
10940757|NCT00762073|EG003|Reported Event|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
10940758|NCT00762086|BG000|Baseline|Treatment Group|AngioPress IPC Device
10940759|NCT00762086|BG001|Baseline|Control Group|Aspirin/Clopidegrol and Standard walking exercises
10940760|NCT00762086|BG002|Baseline|Total|Total of all reporting groups
10940761|NCT00762086|FG000|Participant Flow|Treatment Group|AngioPress IPC Device
10940762|NCT00762086|FG001|Participant Flow|Control Group|Aspirin/Clopidegrol and Standard walking exercises
10940763|NCT00762086|OG000|Outcome|Treatment Group|AngioPress IPC Device
10940764|NCT00762086|OG001|Outcome|Control Group|Aspirin/Clopidegrol and Standard walking exercises
10940765|NCT00762086|EG000|Reported Event|Treatment Group|AngioPress IPC Device
10940766|NCT00762086|EG001|Reported Event|Control Group|Aspirin/Clopidegrol and Standard walking exercises
10940767|NCT00762164|BG000|Baseline|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
10940768|NCT00762164|BG001|Baseline|Simvastatin|Simvastatin 20 milligrams
10940769|NCT00762164|BG002|Baseline|Total|Total of all reporting groups
10940770|NCT00762164|FG000|Participant Flow|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
10940771|NCT00762164|FG001|Participant Flow|Simvastatin|Simvastatin 20 milligrams
10940772|NCT00762164|OG000|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
10940773|NCT00762164|OG001|Outcome|Simvastatin|Simvastatin 20 milligrams
10940774|NCT00762164|EG000|Reported Event|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
10940775|NCT00762164|EG001|Reported Event|Simvastatin|Simvastatin 20 milligrams
10940776|NCT00762177|BG000|Baseline|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
10940777|NCT00762177|BG001|Baseline|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
10940778|NCT00762177|BG002|Baseline|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
10940779|NCT00762177|BG003|Baseline|Total|Total of all reporting groups
10940780|NCT00762177|FG000|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
10940781|NCT00762177|FG001|Participant Flow|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
10940782|NCT00762177|FG002|Participant Flow|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
10940783|NCT00762177|OG000|Outcome|Placebo Toothpaste|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
10940784|NCT00762177|OG001|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).
10940785|NCT00762177|OG002|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
10940786|NCT00762177|OG000|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only)
10940787|NCT00762177|OG001|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
10940788|NCT00762177|OG000|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
10940789|NCT00762177|EG000|Reported Event|Placebo - Fluoride Control|Fluoride only toothpaste (Crest Anti-Cavity)
10940790|NCT00762177|EG001|Reported Event|Active Comparator|Active Comparator toothpaste containing fluoride/triclosan/copolymer (Total)
10940791|NCT00762177|EG002|Reported Event|Experimental|Experimental test product (stannous fluoride toothpaste)
10940792|NCT00762216|BG000|Baseline|Toric|Implantation with the AcrySof® Toric intraocular lens
10940793|NCT00762216|FG000|Participant Flow|Toric|Implantation with the AcrySof® Toric intraocular lens
10940794|NCT00762216|OG000|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
10940795|NCT00762216|EG000|Reported Event|Toric|Implantation with the AcrySof® Toric intraocular lens
10940796|NCT00762229|BG000|Baseline|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
10940797|NCT00762229|BG001|Baseline|Ezetimibe 5 mg|Ezetimibe 5 mg,
10940798|NCT00762229|BG002|Baseline|Total|Total of all reporting groups
10940799|NCT00762229|FG000|Participant Flow|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
11240715|NCT02481297|EG001|Reported Event|Cohort 2: Untreated With High-rRisk mMolecular Features|"Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.~Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.~Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12."
10940800|NCT00762229|FG001|Participant Flow|Ezetimibe 5 mg|Ezetimibe 5 mg,
10940801|NCT00762229|OG000|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
10940802|NCT00762229|OG001|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
10940803|NCT00762229|EG000|Reported Event|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
10940804|NCT00762229|EG001|Reported Event|Ezetimibe 5 mg|Ezetimibe 5 mg,
10940805|NCT00762268|BG000|Baseline|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
10940806|NCT00762268|BG001|Baseline|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
10940807|NCT00762268|BG002|Baseline|Total|Total of all reporting groups
10940808|NCT00762268|FG000|Participant Flow|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
10940809|NCT00762268|FG001|Participant Flow|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
10940810|NCT00762268|OG000|Outcome|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
10940811|NCT00762268|OG001|Outcome|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
10940812|NCT00762268|EG000|Reported Event|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
10940813|NCT00762268|EG001|Reported Event|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
10940814|NCT00762307|BG000|Baseline|Treatment Group 1|Subjects in Treatment Group 1 were treated using a Cooling Intensity Factor (CIF) of 33 for 60 minutes.
10940815|NCT00762307|BG001|Baseline|Treatment Group 2|Subjects in Treatment Group 2 were treated using CIF 37 for 30 minutes.
10940816|NCT00762307|BG002|Baseline|Treatment Group 3|Subjects in Treatment Group 3 were treated using CIF 37 for 45 minutes.
10940817|NCT00762307|BG003|Baseline|Treatment Group 4|Subjects in Treatment Group 4 were treated using CIF 42 for 30 minutes.
10940818|NCT00762307|BG004|Baseline|Total|Total of all reporting groups
10940819|NCT00762307|FG000|Participant Flow|Treatment Group 1|"Cooling Intensity Factor = 33 Duration = 60 minutes~Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
10940820|NCT00762307|FG001|Participant Flow|Treatment Group 2|"Cooling Intensity Factor = 37 Duration = 30 minutes~Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
11177073|NCT02039115|OG000|Outcome|Prednisone|"Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.~prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision."
11177074|NCT02039115|OG001|Outcome|Placebo|"Placebo tablets will be taken in the same manner as the prednisone arm.~placebo: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision."
10940821|NCT00762307|FG002|Participant Flow|Treatment Group 3|"Cooling Intensity Factor = 37 Duration = 45 minutes~Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
10940822|NCT00762307|FG003|Participant Flow|Treatment Group 4|"Cooling Intensity Factor = 42 Cooling Duration = 30 minutes~Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
10940823|NCT00762307|OG000|Outcome|All Groups|All subjects treated in Groups 1, 2, 3 and 4 are combined for this analysis.
10940824|NCT00762307|OG001|Outcome|Group 1|CIF 33 for 60 minutes
10940825|NCT00762307|OG002|Outcome|Group 2|CIF 37 30 minute duration
10940826|NCT00762307|OG003|Outcome|Group 3|CIF 37 duration 45 minutes
10940827|NCT00762307|OG004|Outcome|Group 4|CIF 42 30 duration 30 minutes
10940828|NCT00762307|OG000|Outcome|Overall Study Population|All subjects treated in Treatment Groups 1,2,3 and 4 are in the Overall Study Population
10940829|NCT00762307|OG001|Outcome|Treatment Group 1|Cooling Intensity Factor= 33 Duration of Cooling = 60 minutes
11177075|NCT02039115|EG000|Reported Event|Prednisone|"Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.~prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision."
11177076|NCT02039115|EG001|Reported Event|Placebo|"Placebo tablets will be taken in the same manner as the prednisone arm.~placebo: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision."
11177077|NCT02039219|BG000|Baseline|Placebo|"Placebo~Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks."
11177078|NCT02039219|BG001|Baseline|10 mg Obeticholic Acid (OCA)|"10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.~10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks."
10940830|NCT00762307|OG002|Outcome|Treatment Group 2|Cooling Intensity Factor = 37 Cooling Duration = 30 minutes
10940831|NCT00762307|OG003|Outcome|Treatment Group 3|Cooling Intensity Factor = 37 Cooling Duration = 45 minutes
10940832|NCT00762307|OG004|Outcome|Treatment Group 4|Cooling Intensity Factor = 42 Cooling Duration = 30 minutes
10940833|NCT00762307|OG000|Outcome|All Groups|Treatment Groups 1, 2, 3 and 4 were combined for this analysis.
10940834|NCT00762307|OG001|Outcome|Treatment Group 1|"Cooling Intensity Factor = 33 Duration = 60 minutes~Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
10940835|NCT00762307|OG002|Outcome|Treatment Group 2|"Cooling Intensity Factor = 37 Duration = 30 minutes~Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
10940836|NCT00762307|OG003|Outcome|Treatment Group 3|"Cooling Intensity Factor = 37 Duration = 45 minutes~Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
10940837|NCT00762307|OG004|Outcome|Treatment Group 4|"Cooling Intensity Factor = 42 Cooling Duration = 30 minutes~Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration."
10940838|NCT00762307|EG000|Reported Event|Treatment Group 1|Subjects from Group 1 were treated using a CIF of 33 for 60 minutes in duration.
10940839|NCT00762307|EG001|Reported Event|Treatment Group 2|Subjects from Group 2 were treated using a CIF of 37 for 30 minutes in duration.
10940840|NCT00762307|EG002|Reported Event|Treatment Group 3|Subjects in Treatment Group 3 were treated using a CIF of 37 for 45 minutes in duration.
10940841|NCT00762307|EG003|Reported Event|Treatment Group 4|Subjects in Treatment Group 4 were treated using a CIF of 42 for 30 minutes in duration.
10940842|NCT00762320|BG000|Baseline|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
10940843|NCT00762320|FG000|Participant Flow|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
10940844|NCT00762320|OG000|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
10940845|NCT00762320|OG000|Outcome|Low Dose Kaletra Baseline Visit|Patient satisfaction score at baseline visit
10940846|NCT00762320|OG001|Outcome|Low Dose Kaletra Week 4 Visit|Patient Satisfaction Score at Week 4 visit
10940847|NCT00762320|OG000|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra
10940848|NCT00762320|OG000|Outcome|Low Dose Kaletra Baseline|Patients receiving Low Dose Kaletra at baseline
10940849|NCT00762320|OG001|Outcome|Low Dose Kaletra Week 4|Patients Receiving Low Dose Kaletra at Week 4
10940850|NCT00762320|EG000|Reported Event|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
10940851|NCT00762359|BG000|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
10940852|NCT00762359|BG001|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
10940853|NCT00762359|BG002|Baseline|Total|Total of all reporting groups
10940854|NCT00762359|FG000|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
10940855|NCT00762359|FG001|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
10940856|NCT00762359|OG000|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
10940857|NCT00762359|OG001|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
10940858|NCT00762359|EG000|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
10940859|NCT00762359|EG001|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
10940860|NCT00762372|BG000|Baseline|BLM 240 N2O Group|Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940861|NCT00762372|BG001|Baseline|BLM 240 O2 Group|Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940862|NCT00762372|BG002|Baseline|Sevoflurane Group|Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940863|NCT00762372|BG003|Baseline|Total|Total of all reporting groups
10940864|NCT00762372|FG000|Participant Flow|BLM 240 N2O Group|Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940865|NCT00762372|FG001|Participant Flow|BLM 240 O2 Group|Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940866|NCT00762372|FG002|Participant Flow|Sevoflurane Group|Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940867|NCT00762372|OG000|Outcome|BLM-240 Group|Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.
10940868|NCT00762372|OG001|Outcome|BLM-240 N2O Group|Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940869|NCT00762372|OG002|Outcome|BLM-240 O2 Group|Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940870|NCT00762372|OG003|Outcome|Sevoflurane Group|Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940871|NCT00762372|OG000|Outcome|BLM-240 N2O Group|Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940872|NCT00762372|OG001|Outcome|BLM-240 O2 Group|Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940873|NCT00762372|OG002|Outcome|Sevoflurane Group|Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940874|NCT00762372|OG001|Outcome|Sevoflurane Group|Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
10940875|NCT00762372|EG000|Reported Event|BLM 240 Group|
10940876|NCT00762372|EG001|Reported Event|BLM 240 N2O Group|
10940877|NCT00762372|EG002|Reported Event|BLM 240 O2 Group|
10940878|NCT00762372|EG003|Reported Event|Sevoflurane Group|
11177079|NCT02039219|BG002|Baseline|Total|Total of all reporting groups
11177080|NCT02039219|FG000|Participant Flow|Placebo|"Placebo~Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks."
11177081|NCT02039219|FG001|Participant Flow|10 mg Obeticholic Acid (OCA)|"10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.~10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks."
11177082|NCT02039219|OG000|Outcome|Placebo|"Placebo~Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks."
10940879|NCT00762385|BG000|Baseline|Completed Population|Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study.
10940880|NCT00762385|FG000|Participant Flow|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
10940881|NCT00762385|FG001|Participant Flow|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
10940882|NCT00762385|OG000|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
10940883|NCT00762385|OG001|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or second intervention period.
10940884|NCT00762385|OG000|Outcome|Galyfilcon A|
10940885|NCT00762385|OG001|Outcome|Comfilcon A|
10940886|NCT00762385|OG001|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or the second intervention period.
10940887|NCT00762385|EG000|Reported Event|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
10940888|NCT00762385|EG001|Reported Event|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
10940889|NCT00762411|BG000|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10940890|NCT00762411|BG001|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
10940891|NCT00762411|BG002|Baseline|Total|Total of all reporting groups
10940892|NCT00762411|FG000|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10940893|NCT00762411|FG001|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
10940894|NCT00762411|OG000|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
11177083|NCT02039219|OG001|Outcome|10 mg Obeticholic Acid (OCA)|"10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.~10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks."
10940895|NCT00762411|OG001|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
10940896|NCT00762411|EG000|Reported Event|Placebo- (Initial Treatment Period [NT])|Participants received placebo orally once daily for the first 76 weeks.
10940897|NCT00762411|EG001|Reported Event|140 mg LY450139- NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 76.
10940898|NCT00762411|EG002|Reported Event|Placebo- (Delayed Start Period [DO])|After Week 76, participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
10940899|NCT00762411|EG003|Reported Event|140 mg LY450139- DO|After Week 76, participants received 140 mg LY450139 orally once daily until Week 88.
10940900|NCT00762411|EG004|Reported Event|Placebo-Safety Follow Up Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
10940901|NCT00762411|EG005|Reported Event|140 mg LY450139 - SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
10940902|NCT00762424|BG000|Baseline|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
10940903|NCT00762424|BG001|Baseline|Placebo|placebo: cornstarch
10940904|NCT00762424|BG002|Baseline|Total|Total of all reporting groups
10940905|NCT00762424|FG000|Participant Flow|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
10940906|NCT00762424|FG001|Participant Flow|Placebo|placebo: cornstarch
10940907|NCT00762424|OG000|Outcome|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
10940908|NCT00762424|OG001|Outcome|Placebo|placebo: cornstarch
10940909|NCT00762424|EG000|Reported Event|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
10940910|NCT00762424|EG001|Reported Event|Placebo|placebo: cornstarch
10940911|NCT00762450|BG000|Baseline|Placebo First, Positive Control Second and Experimental Last|
10940912|NCT00762450|BG001|Baseline|Positive Control First, Experimental Second and Placebo Last|
10940913|NCT00762450|BG002|Baseline|Experimental First, Placebo Second and Positive Control Last|
10940914|NCT00762450|BG003|Baseline|Total|Total of all reporting groups
10940915|NCT00762450|FG000|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
10940916|NCT00762450|FG001|Participant Flow|Active Comparator 1st, Experimental 2nd and Placebo Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
10940917|NCT00762450|FG002|Participant Flow|Experimental 1st, Placebo 2nd and Active Comparator Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
10940918|NCT00762450|OG000|Outcome|Active Comparator|
10940919|NCT00762450|OG001|Outcome|Placebo - Silica Control|
10940920|NCT00762450|OG002|Outcome|Experimental Toothpaste|
10940921|NCT00762450|EG000|Reported Event|Placebo First, Positive Control Second and Experimental Last|
10940922|NCT00762450|EG001|Reported Event|Positive Control First, Experimental Second and Placebo Last|
10940923|NCT00762450|EG002|Reported Event|Experimental First, Placebo Second and Positive Control Last|
11177084|NCT02039219|EG000|Reported Event|Placebo|"Placebo~Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks."
11177085|NCT02039219|EG001|Reported Event|10 mg Obeticholic Acid (OCA)|"10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.~10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks."
10940924|NCT00762463|BG000|Baseline|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
10940925|NCT00762463|BG001|Baseline|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
10940926|NCT00762463|BG002|Baseline|Total|Total of all reporting groups
10940927|NCT00762463|FG000|Participant Flow|Celecoxib 200 mg|Celecoxib 200 milligram (mg) capsule once daily
10940928|NCT00762463|FG001|Participant Flow|Diclofenac SR 75 mg|Diclofenac sustained release (SR) 75 mg tablet once daily
10940929|NCT00762463|FG002|Participant Flow|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
10940930|NCT00762463|FG003|Participant Flow|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
10940931|NCT00762463|OG000|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
10940932|NCT00762463|OG001|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
10940933|NCT00762463|OG002|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
10940934|NCT00762463|OG003|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
11240716|NCT02481375|BG000|Baseline|Multiple Micronutrients With Iron|"Multiple micronutrient formulations were based on the UNICEF/WHO/UNU standard formulation for pregnant and lactating women (UNIMMAP) with increased iron (from 30 mg to 60 mg elemental iron) for comparability to the iron only group (60 mg). This formulation has 15 micronutrients including iron.~Women will receive the multiple micronutrient with iron for 12 weeks.~Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine~Iron: 12-wk supplementation of iron"
10940935|NCT00762463|OG003|Outcome|Diclofenac 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 and Celecoxib 400 mg once daily from Week 6 to Week 12
10940936|NCT00762463|EG000|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6
10940937|NCT00762463|EG001|Reported Event|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6
10940938|NCT00762463|EG002|Reported Event|Celecoxib 200 mg, Then Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 200 mg capsule once daily from Week 6 to Week 12
10940939|NCT00762463|EG003|Reported Event|Diclofenac SR 75 mg, Then Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Diclofenac SR 75 mg tablet once daily from Week 6 to Week 12
10940940|NCT00762463|EG004|Reported Event|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
10940941|NCT00762463|EG005|Reported Event|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
10940942|NCT00762476|BG000|Baseline|Placebo|Modified AV Lotion without active ingredients.
10940943|NCT00762476|BG001|Baseline|3804-250A|Experimental AV Lotion
10940944|NCT00762476|BG002|Baseline|Total|Total of all reporting groups
10940945|NCT00762476|FG000|Participant Flow|Placebo|Modified AV Lotion without active ingredients.
10940946|NCT00762476|FG001|Participant Flow|3804-250A|Experimental AV Lotion
10940947|NCT00762476|OG000|Outcome|Placebo|Modified AV Lotion without active ingredients
10940948|NCT00762476|OG001|Outcome|3804-250A|Experimental AV Lotion
10940949|NCT00762476|OG000|Outcome|Placebo|Modified AV Lotion without active ingredients.
10940950|NCT00762476|EG000|Reported Event|Placebo|Modified AV Lotion without active ingredients.
10940951|NCT00762476|EG001|Reported Event|3804-250A|Experimental AV Lotion
10940952|NCT00762502|BG000|Baseline|Senofilcon A Toric Bilaterally|senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
10940953|NCT00762502|BG001|Baseline|Balafilcon A Toric Bilaterally|balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
10940954|NCT00762502|BG002|Baseline|Senofilcon A/Balafilcon A Contralaterally|senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
10940955|NCT00762502|BG003|Baseline|Total|Total of all reporting groups
10940956|NCT00762502|FG000|Participant Flow|Senofilcon A Bilaterally|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
10940957|NCT00762502|FG001|Participant Flow|Balafilcon A Bilaterally|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
10940958|NCT00762502|FG002|Participant Flow|Senofilcon A Toric/Balafilcon A Toric Contralaterally|Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
10940959|NCT00762502|OG000|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
10940960|NCT00762502|OG001|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
10940961|NCT00762502|EG000|Reported Event|Senofilcon A|senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
10940962|NCT00762502|EG001|Reported Event|Balafilcon A|balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
10940963|NCT00762515|BG000|Baseline|A -Placebo Comparator|Fluoride toothpaste
10940964|NCT00762515|BG001|Baseline|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
10940965|NCT00762515|BG002|Baseline|Total|Total of all reporting groups
10940966|NCT00762515|FG000|Participant Flow|A -Placebo Comparator|Fluoride toothpaste
10940967|NCT00762515|FG001|Participant Flow|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
10940968|NCT00762515|OG000|Outcome|A -Placebo Comparator|Fluoride toothpaste
10940969|NCT00762515|OG001|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
10940970|NCT00762515|EG000|Reported Event|A -Placebo Comparator|Fluoride toothpaste
10940971|NCT00762515|EG001|Reported Event|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
10940972|NCT00762528|BG000|Baseline|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
10940973|NCT00762528|BG001|Baseline|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
10940974|NCT00762528|BG002|Baseline|Total|Total of all reporting groups
10940975|NCT00762528|FG000|Participant Flow|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
11177086|NCT02039375|BG000|Baseline|"Hopkins Post tPA Monitoring Protocol"|"Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the Hopkins post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA.~Hopkins post tPA for ischemic stroke monitoring protocol: The Hopkins post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours."
11240717|NCT02481375|BG001|Baseline|Multiple Micronutrients Without Iron|"This formulation has the 14 micronutrients included in the UNIMMAP formulation, but does not include iron.~Women will receive the multiple micronutrient without iron for 12 weeks.~Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine"
11240718|NCT02481375|BG002|Baseline|Iron Only|"This formulation only has 60 mg elemental iron.~Women will receive iron for 12 weeks.~Iron: 12-wk supplementation of iron"
10940976|NCT00762528|FG001|Participant Flow|Fluoride Toothpaste|Sodium monofluorophosphate toothpaste
10940977|NCT00762528|OG000|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
10940978|NCT00762528|OG001|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
10940979|NCT00762528|EG000|Reported Event|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
10940980|NCT00762528|EG001|Reported Event|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
10940981|NCT00762606|BG000|Baseline|Phaco|cataract extraction surgery utilizing Phacoemulsification
10940982|NCT00762606|BG001|Baseline|SICS|Small incision cataract surgery (SICS)
10940983|NCT00762606|BG002|Baseline|Total|Total of all reporting groups
10940984|NCT00762606|FG000|Participant Flow|Phaco|cataract extraction surgery utilizing Phacoemulsification
10940985|NCT00762606|FG001|Participant Flow|SICS|Small incision cataract surgery (SICS)
10940986|NCT00762606|OG000|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
10940987|NCT00762606|OG001|Outcome|SICS|Small incision cataract surgery (SICS)
10940988|NCT00762606|EG000|Reported Event|Phaco|cataract extraction surgery utilizing Phacoemulsification
10940989|NCT00762606|EG001|Reported Event|SICS|Small incision cataract surgery (SICS)
10940990|NCT00762619|BG000|Baseline|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
10940991|NCT00762619|BG001|Baseline|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
10940992|NCT00762619|BG002|Baseline|Total|Total of all reporting groups
10940993|NCT00762619|FG000|Participant Flow|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
10940994|NCT00762619|FG001|Participant Flow|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
10940995|NCT00762619|OG000|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
10940996|NCT00762619|OG001|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
10940997|NCT00762619|OG000|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
10940998|NCT00762619|OG001|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
10940999|NCT00762619|EG000|Reported Event|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
10941000|NCT00762619|EG001|Reported Event|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
10941001|NCT00762645|BG000|Baseline|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
10941002|NCT00762645|BG001|Baseline|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
10941003|NCT00762645|BG002|Baseline|Total|Total of all reporting groups
10941004|NCT00762645|FG000|Participant Flow|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
10941005|NCT00762645|FG001|Participant Flow|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
10941006|NCT00762645|OG000|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
10941007|NCT00762645|OG001|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
10941008|NCT00762645|EG000|Reported Event|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
10941009|NCT00762645|EG001|Reported Event|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
10941010|NCT00762710|BG000|Baseline|Prazosin|"Prazosin medication~Prazosin medication: Form: Prazosin will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
10941011|NCT00762710|BG001|Baseline|Placebo|"Placebo medication~Placebo medication: Form: Placebo will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
10941012|NCT00762710|BG002|Baseline|Total|Total of all reporting groups
10941013|NCT00762710|FG000|Participant Flow|Prazosin|"Prazosin medication~Prazosin medication: Form: Prazosin will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
10941014|NCT00762710|FG001|Participant Flow|Placebo|"Placebo medication~Placebo medication: Form: Placebo will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
10941015|NCT00762710|OG000|Outcome|Prazosin|"Prazosin medication~Prazosin medication: Form: Prazosin will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
10941016|NCT00762710|OG001|Outcome|Placebo|"Placebo medication~Placebo medication: Form: Placebo will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
10941017|NCT00762710|EG000|Reported Event|Prazosin|"Prazosin medication~Prazosin medication: Form: Prazosin will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
10941018|NCT00762710|EG001|Reported Event|Placebo|"Placebo medication~Placebo medication: Form: Placebo will be taken orally, in the form of pills.~Dosing: 9 AM, 3 PM, 9 PM~Days 1-2: 0 mg, 0 mg, 1 mg~Days 3-4: 1 mg, 1 mg, 1 mg~Days 5-7: 2 mg, 2 mg, 2 mg~Day 8-10: 2 mg, 2 mg, 6 mg~Day 11-14: 4 mg, 4 mg, 6 mg~Day 15-84: 4 mg, 4 mg, 8 mg"
10941019|NCT00762762|BG000|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
10941020|NCT00762762|BG001|Baseline|Placebo Comparator|Anti-cavity, fluoride oral rinse
10941021|NCT00762762|BG002|Baseline|Total|Total of all reporting groups
10941022|NCT00762762|FG000|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
10941023|NCT00762762|FG001|Participant Flow|Placebo Comparator|Anti-cavity, fluoride oral rinse
10941024|NCT00762762|OG000|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
10941025|NCT00762762|OG001|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
10941026|NCT00762762|EG000|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
10941027|NCT00762762|EG001|Reported Event|Placebo Comparator|Anti-cavity, fluoride oral rinse
10941028|NCT00762788|BG000|Baseline|Senofilcon A Contact Lens|ACUVUE OASYS
10941029|NCT00762788|BG001|Baseline|Lotrafilcon A Contact Lens|NIGHT&DAY
10941030|NCT00762788|BG002|Baseline|Lotrafilcon B Contact Lens|O2Optix
10941031|NCT00762788|BG003|Baseline|Balafilcon A Contact Lens|PureVision
10941032|NCT00762788|BG004|Baseline|Comfilcon A Contact Lens|Biofinity
10941033|NCT00762788|BG005|Baseline|Etafilcon A Contact Lens|ACUVUE 2
10941034|NCT00762788|BG006|Baseline|Total|Total of all reporting groups
10941035|NCT00762788|FG000|Participant Flow|Senofilcon A Contact Lens|ACUVUE OASYS
10941036|NCT00762788|FG001|Participant Flow|Lotrafilcon A Contact Lens|NIGHT&DAY
10941037|NCT00762788|FG002|Participant Flow|Lotrafilcon B Contact Lens|O2Optix
10941038|NCT00762788|FG003|Participant Flow|Balafilcon A Contact Lens|PureVision
10941039|NCT00762788|FG004|Participant Flow|Comfilcon A Contact Lens|Biofinity
10941040|NCT00762788|FG005|Participant Flow|Etafilcon A Contact Lens|ACUVUE 2
10941041|NCT00762788|OG000|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
10941042|NCT00762788|OG001|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
10941043|NCT00762788|OG002|Outcome|Lotrafilcon B Contact Lens|O2Optix
10941044|NCT00762788|OG003|Outcome|Balafilcon A Contact Lens|PureVision
10941045|NCT00762788|OG004|Outcome|Comfilcon A Contact Lens|Biofinity
10941046|NCT00762788|OG005|Outcome|Etafilcon A Contact Lens|ACUVUE 2
10941047|NCT00762788|EG000|Reported Event|Senofilcon A Contact Lens|ACUVUE OASYS
10941048|NCT00762788|EG001|Reported Event|Lotrafilcon A Contact Lens|NIGHT&DAY
10941049|NCT00762788|EG002|Reported Event|Lotrafilcon B Contact Lens|O2Optix
10941050|NCT00762788|EG003|Reported Event|Balafilcon A Contact Lens|PureVision
10941051|NCT00762788|EG004|Reported Event|Comfilcon A Contact Lens|Biofinity
10941052|NCT00762788|EG005|Reported Event|Etafilcon A Contact Lens|ACUVUE 2
10941053|NCT00762853|BG000|Baseline|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
10941054|NCT00762853|BG001|Baseline|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
10941055|NCT00762853|BG002|Baseline|Total|Total of all reporting groups
10941056|NCT00762853|FG000|Participant Flow|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
11240719|NCT02481375|BG003|Baseline|Placebo|"This formulation is a placebo.~Women will receive a placebo for 12 weeks.~Placebo: 12-wk supplementation of placebo"
11177087|NCT02039375|FG000|Participant Flow|"Hopkins Post tPA Monitoring Protocol"|"Patients treated with IV tissue plasminogen activator (tPA) for acute stroke will be monitored in a non-ICU setting following the Hopkins post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA.~Hopkins post tPA for ischemic stroke monitoring protocol: The Hopkins post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours."
11177088|NCT02039375|OG000|Outcome|"Hopkins Post tPA Monitoring Protocol"|"Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the Hopkins post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA.~Hopkins post tPA for ischemic stroke monitoring protocol: The Hopkins post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours."
10941057|NCT00762853|FG001|Participant Flow|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
10941058|NCT00762853|OG000|Outcome|Fluoride Toothpaste (Placebo)|fluoride only toothpaste
10941059|NCT00762853|OG001|Outcome|Active Toothpaste|fluoride/triclosan/copolymer(Active) toothpaste
10941060|NCT00762853|EG000|Reported Event|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
10941061|NCT00762853|EG001|Reported Event|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
10941062|NCT00762892|BG000|Baseline|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
10941063|NCT00762892|BG001|Baseline|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
10941064|NCT00762892|BG002|Baseline|Total|Total of all reporting groups
10941065|NCT00762892|FG000|Participant Flow|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
10941066|NCT00762892|FG001|Participant Flow|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
10941067|NCT00762892|OG000|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
10941068|NCT00762892|OG001|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
10941069|NCT00762892|EG000|Reported Event|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
10941070|NCT00762892|EG001|Reported Event|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
11240720|NCT02481375|BG004|Baseline|Total|Total of all reporting groups
10941071|NCT00762931|BG000|Baseline|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
10941072|NCT00762931|FG000|Participant Flow|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
10941073|NCT00762931|OG000|Outcome|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
10941074|NCT00762931|EG000|Reported Event|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
10941075|NCT00762970|BG000|Baseline|Test Lens 1|Investigational soft contact lens worn daily.
10941076|NCT00762970|BG001|Baseline|Test Lens 2|Investigational soft contact lens worn daily.
10941077|NCT00762970|BG002|Baseline|Control Lens|Spectacle lenses worn daily.
10941078|NCT00762970|BG003|Baseline|Total|Total of all reporting groups
10941079|NCT00762970|FG000|Participant Flow|Test Lens 1|Investigational soft contact lenses worn daily.
10941080|NCT00762970|FG001|Participant Flow|Test Lens 2|Investigational soft contact lenses worn daily.
10941081|NCT00762970|FG002|Participant Flow|Control Lens|Control spectacle lenses worn daily.
10941082|NCT00762970|OG000|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
10941083|NCT00762970|OG001|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
10941084|NCT00762970|OG002|Outcome|Control Lens|Spectacle lenses worn daily.
10941085|NCT00762970|EG000|Reported Event|Test Lens 1|Investigational soft contact lenses worn daily.
10941086|NCT00762970|EG001|Reported Event|Test Lens 2|Investigational soft contact lenses worn daily.
10941087|NCT00762970|EG002|Reported Event|Control Lens|Control spectacle lenses worn daily.
10941088|NCT00762996|BG000|Baseline|Entire Population|
10941089|NCT00762996|FG000|Participant Flow|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
10941090|NCT00762996|FG001|Participant Flow|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
10941091|NCT00762996|FG002|Participant Flow|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
10941092|NCT00762996|FG003|Participant Flow|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
10941093|NCT00762996|OG000|Outcome|Etafilcon A|
10941094|NCT00762996|OG001|Outcome|Omafilcon A|
10941095|NCT00762996|EG000|Reported Event|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
10941096|NCT00762996|EG001|Reported Event|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
10941097|NCT00762996|EG002|Reported Event|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
10941098|NCT00762996|EG003|Reported Event|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
10941099|NCT00763035|BG000|Baseline|Overall Study Sample|Overall Study Sample
10941100|NCT00763035|FG000|Participant Flow|Active Comparator: A: Dobutamine Test Then Regadenoson Test|Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
10941101|NCT00763035|FG001|Participant Flow|Active Comparator: B Regadenoson Test Then Dobutamine|Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
10941102|NCT00763035|OG000|Outcome|Dobutamine|All participants that completed Dobutamine testing
10941103|NCT00763035|OG001|Outcome|Regadenoson|All participants that completed the regadenoson testing
10941104|NCT00763035|EG000|Reported Event|Dobutamine|All participants that completed Dobutamine testing
10941105|NCT00763035|EG001|Reported Event|Regadenoson|All participants that completed the regadenoson testing
10941106|NCT00763048|BG000|Baseline|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
10941107|NCT00763048|BG001|Baseline|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
10941108|NCT00763048|BG002|Baseline|Total|Total of all reporting groups
11177089|NCT02039375|EG000|Reported Event|"Hopkins Post tPA Monitoring Protocol"|"Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the Hopkins post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA.~Hopkins post tPA for ischemic stroke monitoring protocol: The Hopkins post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours."
11177090|NCT02039414|BG000|Baseline|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
10941109|NCT00763048|FG000|Participant Flow|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
10941110|NCT00763048|FG001|Participant Flow|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
10941111|NCT00763048|OG000|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
10941112|NCT00763048|OG001|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
10941113|NCT00763048|EG000|Reported Event|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
10941114|NCT00763048|EG001|Reported Event|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
10941115|NCT00763061|BG000|Baseline|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
10941116|NCT00763061|BG001|Baseline|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
10941117|NCT00763061|BG002|Baseline|Total|Total of all reporting groups
10941118|NCT00763061|FG000|Participant Flow|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
10941119|NCT00763061|FG001|Participant Flow|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
10941120|NCT00763061|OG000|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
10941121|NCT00763061|OG001|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
10941122|NCT00763061|EG000|Reported Event|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
10941123|NCT00763061|EG001|Reported Event|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
10941124|NCT00763139|BG000|Baseline|Baseline Characteristics of Participants|participants who met American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA), age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month
10941125|NCT00763139|FG000|Participant Flow|Placebo 1st, Pioglitazone 2nd|"Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks.~Pioglitazone: 45 mg by mouth once a day for 8 weeks~Placebo: By mouth once a day for 8 weeks"
10941126|NCT00763139|FG001|Participant Flow|Pioglitazone 1st, Placebo 2nd|"Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks.~Pioglitazone: 45 mg by mouth once a day for 8 weeks~Placebo: By mouth once a day for 8 weeks"
10941127|NCT00763139|OG000|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
10941128|NCT00763139|OG001|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
10941129|NCT00763139|OG002|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
10941130|NCT00763139|OG003|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
10941131|NCT00763139|OG001|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
10941132|NCT00763139|OG003|Outcome|Placebo Phase wk After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks on medication are reported here.
10941133|NCT00763139|OG003|Outcome|Placebo Phase After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
10941134|NCT00763139|EG000|Reported Event|Pioglitazone|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking pioglitazone
10941135|NCT00763139|EG001|Reported Event|Placebo|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking placebo
10941136|NCT00763243|BG000|Baseline|Cogmed Working Memory Training|"Cogmed Working Memory Training Program~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
10941137|NCT00763243|FG000|Participant Flow|Cogmed Working Memory Training|"Cogmed Working Memory Training Program~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
10941138|NCT00763243|OG000|Outcome|Screening Visit|"Screening Visit at Study Entry~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
10941139|NCT00763243|OG001|Outcome|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
10941140|NCT00763243|OG002|Outcome|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
10941141|NCT00763243|OG003|Outcome|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
10941142|NCT00763243|OG004|Outcome|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
10941143|NCT00763243|EG000|Reported Event|Screening Visit|"Screening Visit at Study Entry~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
10941144|NCT00763243|EG001|Reported Event|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
10941145|NCT00763243|EG002|Reported Event|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
10941146|NCT00763243|EG003|Reported Event|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
10941147|NCT00763243|EG004|Reported Event|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
10941148|NCT00763256|BG000|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
10941149|NCT00763256|BG001|Baseline|B - Placebo Comparator|fluoride only toothpaste
10941150|NCT00763256|BG002|Baseline|Total|Total of all reporting groups
10941151|NCT00763256|FG000|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
10941152|NCT00763256|FG001|Participant Flow|B - Placebo Comparator|fluoride only toothpaste
10941153|NCT00763256|OG000|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
10941154|NCT00763256|OG001|Outcome|B - Placebo Comparator|fluoride only toothpaste
10941155|NCT00763256|EG000|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
10941156|NCT00763256|EG001|Reported Event|B - Placebo Comparator|fluoride only toothpaste
10941157|NCT00763269|BG000|Baseline|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
10941158|NCT00763269|BG001|Baseline|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
10941159|NCT00763269|BG002|Baseline|Total|Total of all reporting groups
10941160|NCT00763269|FG000|Participant Flow|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
10941161|NCT00763269|FG001|Participant Flow|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
10941162|NCT00763269|OG000|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
10941163|NCT00763269|OG001|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
11177091|NCT02039414|BG001|Baseline|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
11177092|NCT02039414|BG002|Baseline|Total|Total of all reporting groups
11177093|NCT02039414|FG000|Participant Flow|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
11177094|NCT02039414|FG001|Participant Flow|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
11177095|NCT02039414|OG000|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
11177096|NCT02039414|OG001|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
11177097|NCT02039414|EG000|Reported Event|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
11177098|NCT02039414|EG001|Reported Event|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
11177099|NCT02039427|BG000|Baseline|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery~Placebo: Normal saline 2 ml"
11177100|NCT02039427|BG001|Baseline|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177101|NCT02039427|BG002|Baseline|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177102|NCT02039427|BG003|Baseline|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery~Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
11177103|NCT02039427|BG004|Baseline|Total|Total of all reporting groups
11177104|NCT02039427|FG000|Participant Flow|Placebo|"Normal saline(Placebo) 2 ml at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Placebo: Normal saline 2 ml"
11177105|NCT02039427|FG001|Participant Flow|Preketorolac|"Ketorolac 30 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177106|NCT02039427|FG002|Participant Flow|Postketorolac|"Normal saline(Placebo) 2 ml at 5 min before induction and Ketorolac 30 mg at 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177107|NCT02039427|FG003|Participant Flow|Dexamethasone|"Dexamethasone 10 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Dexamethasone: dexamethasone acetate 10 mg mixed with normal saline : total volume of 2 ml"
11177108|NCT02039427|OG000|Outcome|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery~Placebo: Normal saline 2 ml"
11177109|NCT02039427|OG001|Outcome|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177110|NCT02039427|OG002|Outcome|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177111|NCT02039427|OG003|Outcome|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery~Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
11177112|NCT02039427|OG000|Outcome|Placebo|"Normal saline(Placebo) 2 ml at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Placebo: Normal saline 2 ml"
11177113|NCT02039427|OG001|Outcome|Preketorolac|"Ketorolac 30 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177114|NCT02039427|OG002|Outcome|Postketorolac|"Normal saline(Placebo) 2 ml at 5 min before induction and Ketorolac 30 mg at 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
10941164|NCT00763269|EG000|Reported Event|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
10941165|NCT00763269|EG001|Reported Event|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
10963442|NCT00871975|OG000|Outcome|Urodynamics + Tetra NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
10963443|NCT00871975|EG000|Reported Event|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
11177115|NCT02039427|OG003|Outcome|Dexamethasone|"Dexamethasone 10 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Dexamethasone: dexamethasone acetate 10 mg mixed with normal saline : total volume of 2 ml"
11177116|NCT02039427|EG000|Reported Event|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery~Placebo: Normal saline 2 ml"
10963444|NCT00872001|BG000|Baseline|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
11177117|NCT02039427|EG001|Reported Event|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177118|NCT02039427|EG002|Reported Event|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
11177119|NCT02039427|EG003|Reported Event|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery~Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
11177120|NCT02039505|BG000|Baseline|Induction Phase: Cohort 1, Placebo|Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177121|NCT02039505|BG001|Baseline|Induction Phase: Cohort 1, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.
11177122|NCT02039505|BG002|Baseline|Induction Phase: Cohort 2, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177123|NCT02039505|BG003|Baseline|Total|Total of all reporting groups
11177124|NCT02039505|FG000|Participant Flow|Induction Phase: Cohort 1, Placebo|Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177125|NCT02039505|FG001|Participant Flow|Induction Phase: Cohort 1, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.
11177126|NCT02039505|FG002|Participant Flow|Induction Phase: Cohort 2, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177127|NCT02039505|FG003|Participant Flow|Maintenance Phase: Placebo|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.
11177128|NCT02039505|FG004|Participant Flow|Maintenance Phase: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
10963445|NCT00872001|BG001|Baseline|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
11177129|NCT02039505|FG005|Participant Flow|Maintenance Phase: Placebo Continuation|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.
11177130|NCT02039505|FG006|Participant Flow|Open-Label Cohort: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
11177131|NCT02039505|OG000|Outcome|Induction Phase: Cohort 1, Placebo|Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177132|NCT02039505|OG001|Outcome|Induction Phase: Cohort 1, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.
11177133|NCT02039505|OG000|Outcome|Maintenance Phase: Placebo|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.
11177134|NCT02039505|OG001|Outcome|Maintenance Phase: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
11177135|NCT02039505|OG002|Outcome|Induction Phase: Cohort 2, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177136|NCT02039505|OG003|Outcome|Maintenance Phase: Placebo|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.
11177137|NCT02039505|OG004|Outcome|Maintenance Phase: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
11177138|NCT02039505|OG005|Outcome|Maintenance Phase: Placebo Continuation|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.
11177139|NCT02039505|OG006|Outcome|Open-Label Cohort: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
11177140|NCT02039505|OG000|Outcome|Induction Phase: Cohort 1, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.
11177141|NCT02039505|OG001|Outcome|Induction Phase: Cohort 2, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177142|NCT02039505|EG000|Reported Event|Induction Phase: Cohort 1, Placebo|Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177143|NCT02039505|EG001|Reported Event|Induction Phase: Cohort 1, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.
11177144|NCT02039505|EG002|Reported Event|Induction Phase: Cohort 2, Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
11177145|NCT02039505|EG003|Reported Event|Maintenance Phase: Placebo|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.
10963446|NCT00872001|BG002|Baseline|Total|Total of all reporting groups
10941166|NCT00763282|BG000|Baseline|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
10941167|NCT00763282|BG001|Baseline|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
10941168|NCT00763282|BG002|Baseline|Total|Total of all reporting groups
10941169|NCT00763282|FG000|Participant Flow|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
10941170|NCT00763282|FG001|Participant Flow|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
10941171|NCT00763282|OG000|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
10941172|NCT00763282|OG001|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
10941173|NCT00763282|OG000|Outcome|SM+MI Group|Self Management (SM) + Motivational Interviewing (MI). Motivational Interviewing (MI) is an evidence-based form of counseling to improve behavior change. Self Management (SM) includes: 1) ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
10941174|NCT00763282|OG001|Outcome|ED Group|"An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.~The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
10941175|NCT00763282|EG000|Reported Event|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
10941176|NCT00763282|EG001|Reported Event|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
10941177|NCT00763321|BG000|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
10941178|NCT00763321|BG001|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
10941179|NCT00763321|BG002|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
10941180|NCT00763321|BG003|Baseline|Total|Total of all reporting groups
10941181|NCT00763321|FG000|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
10941182|NCT00763321|FG001|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
11234294|NCT02433496|FG000|Participant Flow|Physician Coaching|"This group included 4 intervention primary care clinics that received an organizational coaching intervention that included in-person site visits and phone/email communication. Each participating clinic was designated one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit, a follow-up site visit, and communicating with the coach throughout the 6-month follow-up period.~Physician coaching: The coach presented the latest research on the benefits and risks of long-term opioid use. The coach helped the clinic team flowchart clinical workflows and determined the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.~The coach helped the team implement ideas using Plan-Do-Study-Act change cycles and maintained contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice."
11234295|NCT02433496|FG001|Participant Flow|Control Group|This group included 4 control primary care clinics that did not receive any intervention. A de-identified dataset was created to examine differences in outcome variables between intervention and control clinics.
11234296|NCT02433496|FG002|Participant Flow|Refused Group|Clinics were invited to join the study, but refused to receive the intervention. Clinics reason for refusal was lack of staff or time. Data was not collected or analyzed for clinics that refused the intervention.
11234297|NCT02433496|OG000|Outcome|Physician Coaching|"This group included 4 intervention primary care clinics that received an organizational coaching intervention that included in-person site visits and phone/email communication. Each participating clinic was designated one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit, a follow-up site visit, and communicating with the coach throughout the 6-month follow-up period.~Physician coaching: The coach presented the latest research on the benefits and risks of long-term opioid use. The coach helped the clinic team flowchart clinical workflows and determined the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.~The coach helped the team implement ideas using Plan-Do-Study-Act change cycles and maintained contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice."
11234298|NCT02433496|OG001|Outcome|Control Group|This group included 4 control primary care clinics that did not receive any intervention. A de-identified dataset was created to examine differences in outcome variables between intervention and control clinics.
11234299|NCT02433496|OG002|Outcome|Refused Group|This group included 3 primary care clinics that were approached to participate in the study, but refused to participate.
11234300|NCT02433496|EG000|Reported Event|Physician Coaching|"This group included 4 intervention primary care clinics that received an organizational coaching intervention that included in-person site visits and phone/email communication. Each participating clinic was designated one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit, a follow-up site visit, and communicating with the coach throughout the 6-month follow-up period.~Physician coaching: The coach presented the latest research on the benefits and risks of long-term opioid use. The coach helped the clinic team flowchart clinical workflows and determined the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.~The coach helped the team implement ideas using Plan-Do-Study-Act change cycles and maintained contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice."
11234301|NCT02433496|EG001|Reported Event|Control Group|This group included 4 control primary care clinics that did not receive any intervention. A de-identified dataset was created to examine differences in outcome variables between intervention and control clinics.
10941183|NCT00763321|FG002|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
11234302|NCT02433613|BG000|Baseline|Phased RFA System|"Observation study / registry with one patient group. Data on the use of the Phased AF system in the real world clinical practice / daily routine of EP laboratories utilizing the Phased AF system was collected."
11234303|NCT02433613|FG000|Participant Flow|Phased RFA System|"Observation study / registry with one patient group. Data on the use of the Phased AF system in the real world clinical practice / daily routine of EP (electrophysiology) laboratories utilizing the Phased AF system was collected."
11234304|NCT02433613|OG000|Outcome|Phased RFA System|"Observation study / registry with one patient group. Data on the use of the Phased AF system in the real world clinical practice / daily routine of EP laboratories utilizing the Phased AF system was collected."
11234305|NCT02433613|EG000|Reported Event|Phased RFA System|"Observation study / registry with one patient group. Data on the use of the Phased AF system in the real world clinical practice / daily routine of EP laboratories utilizing the Phased AF system was collected."
11234306|NCT02433665|BG000|Baseline|Fixed Dose|"100 of the first 200 subjects will be randomized to a fixed dose of contrast material.~Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine)."
11341654|NCT03686033|OG002|Outcome|Treatment C: E2082 25 mg|Participants received, E2082 25 mg tablet, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
11341655|NCT03686033|OG003|Outcome|Open-label Treatment: E2082 40 mg|Participants received, E2082 40 mg, tablet, orally, once on Day 1 of Treatment Period 4 in all the sequences.
10941184|NCT00763321|OG000|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
10941185|NCT00763321|OG001|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
10941186|NCT00763321|EG000|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
10941187|NCT00763321|EG001|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
10941188|NCT00763321|EG002|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
10941189|NCT00763360|BG000|Baseline|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
10941190|NCT00763360|BG001|Baseline|Healon|Healon
10941191|NCT00763360|BG002|Baseline|Amvisc Plus|Amvisc Plus
10941192|NCT00763360|BG003|Baseline|Total|Total of all reporting groups
10941193|NCT00763360|FG000|Participant Flow|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
10941194|NCT00763360|FG001|Participant Flow|Healon|Healon
10941195|NCT00763360|FG002|Participant Flow|Amvisc Plus|Amvisc Plus
10941196|NCT00763360|OG000|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
10941197|NCT00763360|OG001|Outcome|Healon|Healon
10941198|NCT00763360|OG002|Outcome|Amvisc Plus|Amvisc Plus
10941199|NCT00763360|EG000|Reported Event|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
10941200|NCT00763360|EG001|Reported Event|Healon|Healon
10941201|NCT00763360|EG002|Reported Event|Amvisc Plus|Amvisc Plus
10941202|NCT00763386|BG000|Baseline|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
10941203|NCT00763386|BG001|Baseline|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
10941204|NCT00763386|BG002|Baseline|Total|Total of all reporting groups
10941205|NCT00763386|FG000|Participant Flow|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
10941206|NCT00763386|FG001|Participant Flow|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
10941207|NCT00763386|OG000|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
11177146|NCT02039505|EG004|Reported Event|Maintenance Phase: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
10941208|NCT00763386|OG001|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
10941209|NCT00763386|EG000|Reported Event|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
10941210|NCT00763386|EG001|Reported Event|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
10941211|NCT00763412|BG000|Baseline|Patients Who Received Placebo|All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels >126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
10941212|NCT00763412|BG001|Baseline|Patients Who Received Repaglinide|All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels >126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
10941213|NCT00763412|BG002|Baseline|Total|Total of all reporting groups
10941214|NCT00763412|FG000|Participant Flow|Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
10941215|NCT00763412|FG001|Participant Flow|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
10941216|NCT00763412|OG000|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
10941217|NCT00763412|OG001|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
10941218|NCT00763412|EG000|Reported Event|Placebo|Placebo group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
10941219|NCT00763412|EG001|Reported Event|Repaglinide|Repaglinide intervention group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
10941220|NCT00763451|BG000|Baseline|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10941221|NCT00763451|BG001|Baseline|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
10941222|NCT00763451|BG002|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10941223|NCT00763451|BG003|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
10941224|NCT00763451|BG004|Baseline|Total|Total of all reporting groups
10941225|NCT00763451|FG000|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10941226|NCT00763451|FG001|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
10941227|NCT00763451|FG002|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10941228|NCT00763451|FG003|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
10941229|NCT00763451|OG000|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
10941230|NCT00763451|OG001|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
10941231|NCT00763451|OG002|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
10941232|NCT00763451|EG000|Reported Event|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo.
10941233|NCT00763451|EG001|Reported Event|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo.
10941234|NCT00763451|EG002|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
10941235|NCT00763451|EG003|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
11341656|NCT03686033|OG003|Outcome|Open-label Treatment: E2082 40 mg|Participants received, E2082 40 mg tablet, orally, once on Day 1 of Treatment Period 4 in all the sequences.
11341657|NCT03686033|OG000|Outcome|Treatment B: E2082 2.5 mg|Participants received, E2082 2.5 mg tablet, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10941236|NCT00763451|EG004|Reported Event|Lixisenatide One-step Titration|1-step initiation regimen of lixisenatide.
10941237|NCT00763451|EG005|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
10941238|NCT00763490|BG000|Baseline|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
10941239|NCT00763490|FG000|Participant Flow|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
10941240|NCT00763490|OG000|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
10941241|NCT00763490|EG000|Reported Event|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
10941242|NCT00763698|BG000|Baseline|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
10941243|NCT00763698|FG000|Participant Flow|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
10941244|NCT00763698|OG000|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
10941245|NCT00763698|OG000|Outcome|QuickFlex Micro 1258T Left Heart Leads|Patients included in this analysis include the first 16 patients to provide LV lead bipolar pacing capture threshold data at 3 months with a pulse width of 0.5 ms.
10941246|NCT00763698|EG000|Reported Event|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
10941247|NCT00763750|BG000|Baseline|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
10941248|NCT00763750|FG000|Participant Flow|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
10941249|NCT00763750|OG000|Outcome|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
10941250|NCT00763750|EG000|Reported Event|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
10941251|NCT00763815|BG000|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10941252|NCT00763815|BG001|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg once daily QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10941253|NCT00763815|BG002|Baseline|Total|Total of all reporting groups
10941254|NCT00763815|FG000|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10941255|NCT00763815|FG001|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
10941256|NCT00763815|OG000|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
10941257|NCT00763815|OG001|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
10941258|NCT00763815|EG000|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
10941259|NCT00763815|EG001|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
10941260|NCT00763867|BG000|Baseline|Placebo|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
10941261|NCT00763867|BG001|Baseline|Sildenafil|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
10941262|NCT00763867|BG002|Baseline|Total|Total of all reporting groups
10941263|NCT00763867|FG000|Participant Flow|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
10941264|NCT00763867|FG001|Participant Flow|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
10941265|NCT00763867|OG000|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
10941266|NCT00763867|OG001|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
10941267|NCT00763867|EG000|Reported Event|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
10941268|NCT00763867|EG001|Reported Event|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
10941269|NCT00763919|BG000|Baseline|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
10941270|NCT00763919|FG000|Participant Flow|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
10941271|NCT00763919|OG000|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
10941272|NCT00763919|EG000|Reported Event|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
10941273|NCT00763958|BG000|Baseline|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
10941274|NCT00763958|BG001|Baseline|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
10941275|NCT00763958|BG002|Baseline|Total|Total of all reporting groups
10941276|NCT00763958|FG000|Participant Flow|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
10941277|NCT00763958|FG001|Participant Flow|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
10941278|NCT00763958|OG000|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
10941279|NCT00763958|OG001|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
10941280|NCT00763958|OG000|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of stuty drug based on clinical assessment.
10941281|NCT00763958|EG000|Reported Event|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
10941282|NCT00763958|EG001|Reported Event|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
10941283|NCT00763971|BG000|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
10941284|NCT00763971|BG001|Baseline|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
10941285|NCT00763971|BG002|Baseline|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
10941286|NCT00763971|BG003|Baseline|Total|Total of all reporting groups
10941287|NCT00763971|FG000|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
10941288|NCT00763971|FG001|Participant Flow|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
10941289|NCT00763971|FG002|Participant Flow|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
10941290|NCT00763971|OG000|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
10941291|NCT00763971|OG001|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
10941292|NCT00763971|OG002|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
10941293|NCT00763971|EG000|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
10941294|NCT00763971|EG001|Reported Event|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
10941295|NCT00763971|EG002|Reported Event|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
10941296|NCT00764309|BG000|Baseline|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
10941297|NCT00764309|FG000|Participant Flow|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
10941298|NCT00764309|OG000|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
10941299|NCT00764309|EG000|Reported Event|Dasatinib|
10941300|NCT00764322|BG000|Baseline|Extensive and Ultra-rapid Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
10941301|NCT00764322|BG001|Baseline|Intermediate and Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
10941302|NCT00764322|BG002|Baseline|Total|Total of all reporting groups
10941303|NCT00764322|FG000|Participant Flow|Patients Enrolled|
10941304|NCT00764322|OG000|Outcome|Ultra-rapid Metabolizers|Those with the highest transformation of the CYP2D6 genotype to allelic activity
10941305|NCT00764322|OG001|Outcome|Extensive Metabolizers|Those with the most normal transformation of the CYP2D6 genotype to allelic activity
10941306|NCT00764322|OG002|Outcome|Intermediate Metabolizers|Those with reduced transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
10941307|NCT00764322|OG003|Outcome|Poor Metabolizers|Those with no transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
10941308|NCT00764322|OG000|Outcome|Tamoxifen 20|"One arm, containing the ultra-rapid and extensive metabolizer genotypes, continues treatment with tamoxifen at 20mg.~tamoxifen citrate: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.~gene expression analysis: Genetic analysis of blood sample.~pharmacogenomic studies: Genetic analysis of blood sample.~questionnaire administration: Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months~quality-of-life assessment: Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months."
10941309|NCT00764322|OG001|Outcome|Tamoxifen 40|"This arm, containing the intermediate and poor metabolizer genotypes, receives escalated treatment with tamoxifen at 40mg.~tamoxifen citrate: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.~gene expression analysis: Genetic analysis of blood sample.~pharmacogenomic studies: Genetic analysis of blood sample.~questionnaire administration: Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months~quality-of-life assessment: Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months."
10941310|NCT00764322|OG000|Outcome|Extensive Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
10941311|NCT00764322|OG001|Outcome|Intermediate Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
10941312|NCT00764322|OG002|Outcome|Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
10941313|NCT00764322|OG000|Outcome|African Americans|Participants who self identified as African American Race
10941314|NCT00764322|OG000|Outcome|Poor Metabolizers|Those with no transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
10941315|NCT00764322|OG000|Outcome|All Participants|All participants in the main study who consented to this additional survey
10941316|NCT00764322|EG000|Reported Event|Ultra-rapid and Extensive Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
10941317|NCT00764322|EG001|Reported Event|Intermediate Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
10941318|NCT00764322|EG002|Reported Event|Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
10941319|NCT00764361|BG000|Baseline|NanoDOX™ Hydrogel|1.0% doxycycline gel
10941320|NCT00764361|BG001|Baseline|Placebo|placebo gel
10941321|NCT00764361|BG002|Baseline|Total|Total of all reporting groups
10941322|NCT00764361|FG000|Participant Flow|NanoDOX™ Hydrogel|1.0% doxycycline gel
10941323|NCT00764361|FG001|Participant Flow|Placebo|placebo gel
10941324|NCT00764361|OG000|Outcome|NanoDOX™ Hydrogel|1.0% doxycycline monohydrate gel
10941325|NCT00764361|OG001|Outcome|Placebo|placebo gel
10941326|NCT00764361|EG000|Reported Event|NanoDOX™ Hydrogel|1.0% doxycycline gel
10941327|NCT00764361|EG001|Reported Event|Placebo|placebo gel
10941328|NCT00764465|BG000|Baseline|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
10941329|NCT00764465|BG001|Baseline|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
10941330|NCT00764465|BG002|Baseline|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
10941331|NCT00764465|BG003|Baseline|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
10941332|NCT00764465|BG004|Baseline|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
10941333|NCT00764465|BG005|Baseline|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10941334|NCT00764465|BG006|Baseline|Total|Total of all reporting groups
10941335|NCT00764465|FG000|Participant Flow|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
10941336|NCT00764465|FG001|Participant Flow|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
10941337|NCT00764465|FG002|Participant Flow|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
10941338|NCT00764465|FG003|Participant Flow|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
10941339|NCT00764465|FG004|Participant Flow|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
10941340|NCT00764465|FG005|Participant Flow|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10941341|NCT00764465|OG000|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
10941342|NCT00764465|OG001|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
10941343|NCT00764465|OG002|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
10941344|NCT00764465|OG000|Outcome|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
10941345|NCT00764465|OG001|Outcome|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
10941346|NCT00764465|OG002|Outcome|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
10941347|NCT00764465|OG003|Outcome|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
10941348|NCT00764465|OG004|Outcome|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
10941349|NCT00764465|OG005|Outcome|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10941350|NCT00764465|EG000|Reported Event|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
10941351|NCT00764465|EG001|Reported Event|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
10941352|NCT00764465|EG002|Reported Event|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
10941353|NCT00764465|EG003|Reported Event|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
10941354|NCT00764465|EG004|Reported Event|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
10941355|NCT00764465|EG005|Reported Event|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10941356|NCT00764491|BG000|Baseline|Optimesh 1500S|"OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws.~OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation."
10941357|NCT00764491|BG001|Baseline|Structural Allograft Spacer|"Structural Allograft Spacer with pedicle screws.~Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation."
10941358|NCT00764491|BG002|Baseline|Total|Total of all reporting groups
10941359|NCT00764491|FG000|Participant Flow|Optimesh 1500S|"OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws.~OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation."
10941360|NCT00764491|FG001|Participant Flow|Structural Allograft Spacer|"Structural Allograft Spacer with pedicle screws.~Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation."
10963447|NCT00872001|FG000|Participant Flow|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
11177147|NCT02039505|EG005|Reported Event|Maintenance Phase: Placebo Continuation|Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.
11177148|NCT02039505|EG006|Reported Event|Open-Label Cohort: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
11177149|NCT02039674|BG000|Baseline|Part1CohortA2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])|Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177150|NCT02039674|BG001|Baseline|Part1CohortA10 (Pembro10mg/kg+Pa+C)|Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177151|NCT02039674|BG002|Baseline|Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])|Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177152|NCT02039674|BG003|Baseline|Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)|Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177153|NCT02039674|BG004|Baseline|Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)|Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177154|NCT02039674|BG005|Baseline|Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)|Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177155|NCT02039674|BG006|Baseline|Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])|Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177156|NCT02039674|BG007|Baseline|Part 1 Cohort D2 (Pembro 10 mg/kg+I)|Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177157|NCT02039674|BG008|Baseline|Part 1 Cohort D4 (Pembro 2 mg/kg+I)|Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177158|NCT02039674|BG009|Baseline|Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)|Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
11177159|NCT02039674|BG010|Baseline|Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)|Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
11177160|NCT02039674|BG011|Baseline|Part 2 Cohort G+ (Pembro 200 mg+Pe+C)|Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
11177161|NCT02039674|BG012|Baseline|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177162|NCT02039674|BG013|Baseline|Part 2 Cohort H (Pembro 2 mg/kg+I)|Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
11177163|NCT02039674|BG014|Baseline|Total|Total of all reporting groups
11177164|NCT02039674|FG000|Participant Flow|Part1CohortA2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])|Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177165|NCT02039674|FG001|Participant Flow|Part1CohortA10 (Pembro10mg/kg+Pa+C)|Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177166|NCT02039674|FG002|Participant Flow|Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])|Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177167|NCT02039674|FG003|Participant Flow|Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)|Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177168|NCT02039674|FG004|Participant Flow|Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)|Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11234307|NCT02433665|BG001|Baseline|Customized Dose|"100 of the first 200 subjects will be randomized to a customized dose of contrast material based on the experimental algorithm. The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm.~Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).~Mydose: 400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters."
11234308|NCT02433665|BG002|Baseline|Total|Total of all reporting groups
11234309|NCT02433665|FG000|Participant Flow|Fixed Dose|"100 of the first 200 subjects will be randomized to a fixed dose of contrast material.~Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine)."
11234310|NCT02433665|FG001|Participant Flow|Customized Dose|"100 of the first 200 subjects will be randomized to a customized dose of contrast material based on the experimental algorithm. The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm.~Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).~Mydose: 400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters."
11234311|NCT02433665|OG000|Outcome|Fixed Dose|"100 of the first 200 subjects will be randomized to a fixed dose of contrast material.~Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine)."
11234312|NCT02433665|OG001|Outcome|Customized Dose|"100 of the first 200 subjects will be randomized to a customized dose of contrast material based on the experimental algorithm. The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm.~Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).~Mydose: 400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters."
11341658|NCT03686033|OG001|Outcome|Treatment C: E2082 25 mg|Participants received, E2082 25 mg tablet, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
11341659|NCT03686033|OG002|Outcome|Open-label Treatment: E2082 40 mg|Participants received, E2082 40 mg tablet, orally, once on Day 1 of Treatment Period 4 in all the sequences.
10941361|NCT00764491|OG000|Outcome|Optimesh 1500S|"OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws.~OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation."
10941362|NCT00764491|OG001|Outcome|Structural Allograft Spacer|"Structural Allograft Spacer with pedicle screws.~Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation."
10941363|NCT00764491|EG000|Reported Event|Optimesh 1500S|"OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws.~OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation."
10941364|NCT00764491|EG001|Reported Event|Structural Allograft Spacer|"Structural Allograft Spacer with pedicle screws.~Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation."
10941365|NCT00764504|BG000|Baseline|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
10941366|NCT00764504|BG001|Baseline|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
10941367|NCT00764504|BG002|Baseline|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
10941368|NCT00764504|BG003|Baseline|Total|Total of all reporting groups
10941369|NCT00764504|FG000|Participant Flow|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
10941370|NCT00764504|FG001|Participant Flow|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
10941371|NCT00764504|FG002|Participant Flow|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
11177169|NCT02039674|FG005|Participant Flow|Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)|Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177170|NCT02039674|FG006|Participant Flow|Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])|Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177171|NCT02039674|FG007|Participant Flow|Part 1 Cohort D2 (Pembro 10 mg/kg+I)|Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177172|NCT02039674|FG008|Participant Flow|Part 1 Cohort D4 (Pembro 2 mg/kg+I)|Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177173|NCT02039674|FG009|Participant Flow|Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)|Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
11177174|NCT02039674|FG010|Participant Flow|Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)|Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
11177175|NCT02039674|FG011|Participant Flow|Part 2 Cohort G+ (Pembro 200 mg+Pe+C)|Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177176|NCT02039674|FG012|Participant Flow|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (C 5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
11177177|NCT02039674|FG013|Participant Flow|Part 2 Cohort H (Pembro 2mg/kg+I)|Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
11177178|NCT02039674|OG000|Outcome|Part 2 Cohort G+ (Pembro 200 mg+Pe+C)|Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
11177179|NCT02039674|OG001|Outcome|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177180|NCT02039674|OG000|Outcome|Part 2 Cohorts D4 & H (Pembro 2mg/kg+I)|Cohort D4 and Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
11177181|NCT02039674|OG000|Outcome|Part1CohortA2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])|Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177182|NCT02039674|OG001|Outcome|Part1CohortA10 (Pembro10mg/kg+Pa+C)|Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177183|NCT02039674|OG002|Outcome|Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])|Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177184|NCT02039674|OG003|Outcome|Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)|Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177185|NCT02039674|OG004|Outcome|Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)|Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177186|NCT02039674|OG005|Outcome|Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)|Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177187|NCT02039674|OG006|Outcome|Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])|Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177188|NCT02039674|OG007|Outcome|Part 1 Cohort D2 (Pembro 10 mg/kg+I)|Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177189|NCT02039674|OG008|Outcome|Part 1 Cohort D4 (Pembro 2 mg/kg+I)|Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
10941372|NCT00764504|OG000|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
10941373|NCT00764504|OG001|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
11177190|NCT02039674|OG009|Outcome|Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)|Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
11177191|NCT02039674|OG010|Outcome|Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)|Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
11177192|NCT02039674|OG011|Outcome|Part 2 Cohort G+ (Pembro 200 mg+Pe+C)|Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
11177193|NCT02039674|OG012|Outcome|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177194|NCT02039674|OG013|Outcome|Part 2 Cohort H (Pembro 2 mg/kg+I)|Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
11177195|NCT02039674|EG000|Reported Event|Part1CohortA2 (Pembro 2mg/kg+Paclitaxel [Pa]+Carboplatin [C])|Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177196|NCT02039674|EG001|Reported Event|Part1 CohortA10 (Pembro10mg/kg+Pa+C)|Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177197|NCT02039674|EG002|Reported Event|Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])|Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177198|NCT02039674|EG003|Reported Event|Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)|Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177199|NCT02039674|EG004|Reported Event|Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)|Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177200|NCT02039674|EG005|Reported Event|Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)|Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177201|NCT02039674|EG006|Reported Event|Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])|Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177202|NCT02039674|EG007|Reported Event|Part 1 Cohort D2 (Pembro 10 mg/kg+I)|Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177203|NCT02039674|EG008|Reported Event|Part 1 Cohort D4 (Pembro 2 mg/kg+I)|Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11177204|NCT02039674|EG009|Reported Event|Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)|Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
11177205|NCT02039674|EG010|Reported Event|Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)|Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
11177206|NCT02039674|EG011|Reported Event|Part 2 Cohort G+ (Pembro 200 mg+Pe+C)|Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
11177207|NCT02039674|EG012|Reported Event|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11177208|NCT02039674|EG013|Reported Event|Part 2 Cohort H (Pembro 2mg/kg+I)|Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
11177209|NCT02039687|BG000|Baseline|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941374|NCT00764504|OG002|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
10941375|NCT00764504|EG000|Reported Event|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
10941376|NCT00764504|EG001|Reported Event|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
10941377|NCT00764504|EG002|Reported Event|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
10941378|NCT00764517|BG000|Baseline|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10941379|NCT00764517|BG001|Baseline|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10941380|NCT00764517|BG002|Baseline|Total|Total of all reporting groups
11177210|NCT02039687|BG001|Baseline|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941381|NCT00764517|FG000|Participant Flow|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
11177211|NCT02039687|BG002|Baseline|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941382|NCT00764517|FG001|Participant Flow|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
11177212|NCT02039687|BG003|Baseline|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
11177213|NCT02039687|BG004|Baseline|Total|Total of all reporting groups
11177214|NCT02039687|FG000|Participant Flow|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941383|NCT00764517|OG000|Outcome|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10941384|NCT00764517|OG001|Outcome|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10941385|NCT00764517|EG000|Reported Event|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10941386|NCT00764517|EG001|Reported Event|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10941387|NCT00764660|BG000|Baseline|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
10941388|NCT00764660|BG001|Baseline|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
10941389|NCT00764660|BG002|Baseline|Total|Total of all reporting groups
10941390|NCT00764660|FG000|Participant Flow|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
10941391|NCT00764660|FG001|Participant Flow|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
11177215|NCT02039687|FG001|Participant Flow|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941392|NCT00764660|OG000|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
10941393|NCT00764660|OG001|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
10941394|NCT00764660|EG000|Reported Event|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
10941395|NCT00764660|EG001|Reported Event|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
10941396|NCT00764673|BG000|Baseline|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
10941397|NCT00764673|FG000|Participant Flow|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
10941398|NCT00764673|OG000|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
10941399|NCT00764673|EG000|Reported Event|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
10941400|NCT00764738|BG000|Baseline|Monthly Ranibizumab 0.5 mg|Intravitreal ranibizumab 0.5 mg dosing monthly for entire study.
10941401|NCT00764738|BG001|Baseline|PRN Ranibizumab 0.5 mg|Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
10941402|NCT00764738|BG002|Baseline|Monthly Ranibizumab 2.0 mg|Intravitreal ranibizumab 2.0 mg dosing monthly for entire study.
10941403|NCT00764738|BG003|Baseline|PRN Ranibizumab 2.0 mg|Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
10941404|NCT00764738|BG004|Baseline|Total|Total of all reporting groups
10941405|NCT00764738|FG000|Participant Flow|Monthly Ranibizumab 0.5 mg|Intravitreal ranibizumab 0.5 mg dosing monthly for entire study.
10941406|NCT00764738|FG001|Participant Flow|PRN Ranibizumab 0.5 mg|Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
10941407|NCT00764738|FG002|Participant Flow|Monthly Ranibizumab 2.0 mg|Intravitreal ranibizumab 2.0 mg dosing monthly for entire study.
10941408|NCT00764738|FG003|Participant Flow|PRN Ranibizumab 2.0 mg|Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
10941409|NCT00764738|OG000|Outcome|Monthly Ranibizumab|Intravitreal ranibizumab injections monthly for entire study.
10941410|NCT00764738|OG001|Outcome|PRN Ranibizumab|Intravitreal ranibizumab injections monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
10941411|NCT00764738|OG002|Outcome|Ranibizumab 0.5 mg|Intravitreal ranibizumab 0.5 mg dosing
10941412|NCT00764738|OG003|Outcome|Ranibizumab 2.0 mg|Intravitreal ranibizumab 2.0 mg dosing.
10941413|NCT00764738|EG000|Reported Event|Monthly Ranibizumab 0.5 mg|Intravitreal ranibizumab 0.5 mg dosing monthly for entire study.
10941414|NCT00764738|EG001|Reported Event|PRN Ranibizumab 0.5 mg|Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
10941415|NCT00764738|EG002|Reported Event|Monthly Ranibizumab 2.0 mg|Intravitreal ranibizumab 2.0 mg dosing monthly for entire study.
10941416|NCT00764738|EG003|Reported Event|PRN Ranibizumab 2.0 mg|Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
10941417|NCT00764751|BG000|Baseline|Group A|"LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week~Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week."
10941418|NCT00764751|BG001|Baseline|Group B|"LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.~LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week."
10941419|NCT00764751|BG002|Baseline|Total|Total of all reporting groups
10941420|NCT00764751|FG000|Participant Flow|Group A|"LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week~Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week."
10941421|NCT00764751|FG001|Participant Flow|Group B|"LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.~LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week."
10941422|NCT00764751|OG000|Outcome|Group A: LEO 19123|LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
10941423|NCT00764751|OG001|Outcome|Group A: Dovonex®|Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
10941424|NCT00764751|OG002|Outcome|Group B: LEO 19123|LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
10941425|NCT00764751|OG003|Outcome|Group B: LEO 19123 Vehicle|LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
10941426|NCT00764751|OG000|Outcome|Group A: LEO 19123|LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
10941427|NCT00764751|OG000|Outcome|Group A|"LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week~Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week."
10941428|NCT00764751|OG001|Outcome|Group B|"LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.~LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week."
10941429|NCT00764751|EG000|Reported Event|Group A|"LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week~Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week."
10941430|NCT00764751|EG001|Reported Event|Group B|"LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.~LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week."
10941431|NCT00764790|BG000|Baseline|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941432|NCT00764790|BG001|Baseline|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941433|NCT00764790|BG002|Baseline|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941434|NCT00764790|BG003|Baseline|Total|Total of all reporting groups
10941435|NCT00764790|FG000|Participant Flow|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941436|NCT00764790|FG001|Participant Flow|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941437|NCT00764790|FG002|Participant Flow|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941438|NCT00764790|OG000|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941439|NCT00764790|OG001|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941440|NCT00764790|OG002|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941441|NCT00764790|EG000|Reported Event|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941442|NCT00764790|EG001|Reported Event|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941443|NCT00764790|EG002|Reported Event|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
10941444|NCT00764868|BG000|Baseline|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
10941445|NCT00764868|FG000|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
10941446|NCT00764868|OG000|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
10941447|NCT00764868|EG000|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
11341660|NCT03686033|EG000|Reported Event|Treatment A: Placebo|Participants received, E2082-matched placebo tablet, orally, once on Day 1 as per assigned Treatment sequence in Treatment Period 1, 2, or 3.
10941448|NCT00764881|BG000|Baseline|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
10941449|NCT00764881|BG001|Baseline|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
10941450|NCT00764881|BG002|Baseline|Total|Total of all reporting groups
10941451|NCT00764881|FG000|Participant Flow|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
10941452|NCT00764881|FG001|Participant Flow|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
10941453|NCT00764881|OG000|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
10941454|NCT00764881|OG001|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
10941455|NCT00764881|EG000|Reported Event|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles
10941456|NCT00764881|EG001|Reported Event|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles
10941457|NCT00764946|BG000|Baseline|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941458|NCT00764946|BG001|Baseline|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941459|NCT00764946|BG002|Baseline|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941460|NCT00764946|BG003|Baseline|Total|Total of all reporting groups
10941461|NCT00764946|FG000|Participant Flow|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator.
10941462|NCT00764946|FG001|Participant Flow|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
11177216|NCT02039687|FG002|Participant Flow|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941463|NCT00764946|FG002|Participant Flow|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941464|NCT00764946|OG000|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941465|NCT00764946|OG001|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941466|NCT00764946|OG002|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941467|NCT00764946|OG000|Outcome|Treatment Experienced - Failing Current Therapy|
10941468|NCT00764946|OG001|Outcome|Treatment-Experienced - Treatment Intolerant|
10941469|NCT00764946|OG002|Outcome|Treatment Naive|
10941470|NCT00764946|OG000|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941471|NCT00764946|OG002|Outcome|Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941472|NCT00764946|OG001|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941473|NCT00764946|EG000|Reported Event|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10963448|NCT00872001|FG001|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
11177217|NCT02039687|FG003|Participant Flow|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
11177218|NCT02039687|OG000|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941474|NCT00764946|EG001|Reported Event|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941475|NCT00764946|EG002|Reported Event|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
10941476|NCT00765037|BG000|Baseline|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
10941477|NCT00765037|FG000|Participant Flow|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
10941478|NCT00765037|OG000|Outcome|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
10941479|NCT00765037|EG000|Reported Event|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
10941480|NCT00765063|BG000|Baseline|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
10941481|NCT00765063|FG000|Participant Flow|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
10941482|NCT00765063|OG000|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
10941483|NCT00765063|EG000|Reported Event|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
10941484|NCT00765076|BG000|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
10941485|NCT00765076|BG001|Baseline|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
10941486|NCT00765076|BG002|Baseline|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
10941487|NCT00765076|BG003|Baseline|Total|Total of all reporting groups
10941488|NCT00765076|FG000|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
10941489|NCT00765076|FG001|Participant Flow|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
10941490|NCT00765076|FG002|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
10941491|NCT00765076|OG000|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
10941492|NCT00765076|OG001|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
10941493|NCT00765076|OG002|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
10941494|NCT00765076|EG000|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
10941495|NCT00765076|EG001|Reported Event|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
11177219|NCT02039687|OG001|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
11177220|NCT02039687|OG002|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941496|NCT00765076|EG002|Reported Event|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
10941497|NCT00765102|BG000|Baseline|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
10941498|NCT00765102|FG000|Participant Flow|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
10941499|NCT00765102|OG000|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
10941500|NCT00765102|OG000|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
10941501|NCT00765102|OG001|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
11177221|NCT02039687|OG003|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
11177222|NCT02039687|EG000|Reported Event|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
11177223|NCT02039687|EG001|Reported Event|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
11341661|NCT03686033|EG001|Reported Event|Treatment B: E2082 2.5 mg|Participants received, E2082 2.5 mg tablet, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10941502|NCT00765102|EG000|Reported Event|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
10941503|NCT00765128|BG000|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941504|NCT00765128|BG001|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941505|NCT00765128|BG002|Baseline|Total|Total of all reporting groups
10941506|NCT00765128|FG000|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941507|NCT00765128|FG001|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941508|NCT00765128|OG000|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941509|NCT00765128|OG001|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941510|NCT00765128|EG000|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941511|NCT00765128|EG001|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941512|NCT00765193|BG000|Baseline|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
10941513|NCT00765193|FG000|Participant Flow|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
10941514|NCT00765193|OG000|Outcome|Problem Area Examination|
10941515|NCT00765193|OG001|Outcome|Full Body Examination|
10941516|NCT00765193|EG000|Reported Event|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
10941517|NCT00765206|BG000|Baseline|Entire Study Population|
10941518|NCT00765206|FG000|Participant Flow|Zegerid First, Then Prilosec (1- Day Dosing)|Participants received Zegerid Over-the-counter (OTC) Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
10941519|NCT00765206|FG001|Participant Flow|Prilosec First, Then Zegerid (1-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
10941520|NCT00765206|FG002|Participant Flow|Zegerid First, Then Prilosec ( 7-Day Dosing)|Participants received Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
10941521|NCT00765206|FG003|Participant Flow|Prilosec First, Then Zegerid (7-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
10941522|NCT00765206|OG000|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
10941523|NCT00765206|OG001|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
10941524|NCT00765206|EG000|Reported Event|Zegerid|Subjects who received a single dose of Zegerid per day for either 1 or 7 days.
10941525|NCT00765206|EG001|Reported Event|Prilosec|Subjects who received a single dose of Prilosec per day for either 1 or 7 days.
10941526|NCT00765232|BG000|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941527|NCT00765232|BG001|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941528|NCT00765232|BG002|Baseline|Total|Total of all reporting groups
10941529|NCT00765232|FG000|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941530|NCT00765232|FG001|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941531|NCT00765232|OG000|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941532|NCT00765232|OG001|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
11177224|NCT02039687|EG002|Reported Event|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
10941533|NCT00765232|EG000|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941534|NCT00765232|EG001|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
10941535|NCT00765245|BG000|Baseline|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
10941536|NCT00765245|BG001|Baseline|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
10941537|NCT00765245|BG002|Baseline|Total|Total of all reporting groups
11177225|NCT02039687|EG003|Reported Event|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
10941538|NCT00765245|FG000|Participant Flow|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
10941539|NCT00765245|FG001|Participant Flow|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
10941540|NCT00765245|OG000|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
10941541|NCT00765245|OG001|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
10941542|NCT00765245|EG000|Reported Event|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
10941543|NCT00765245|EG001|Reported Event|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
10941544|NCT00765336|BG000|Baseline|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
10941545|NCT00765336|BG001|Baseline|Placebo|daily dose of Placebo
10941546|NCT00765336|BG002|Baseline|Total|Total of all reporting groups
10941547|NCT00765336|FG000|Participant Flow|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
10941548|NCT00765336|FG001|Participant Flow|Placebo|daily dose of Placebo
10941549|NCT00765336|OG000|Outcome|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
10941550|NCT00765336|OG001|Outcome|Placebo|daily dose of Placebo
10941551|NCT00765336|EG000|Reported Event|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
10941552|NCT00765336|EG001|Reported Event|Placebo|daily dose of Placebo
10941553|NCT00765362|BG000|Baseline|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
10941554|NCT00765362|FG000|Participant Flow|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
11177226|NCT02039726|BG000|Baseline|Quizartinib|Participants who were randomized to receive 20 or 30 mg Quizartinib tablets administered orally once daily.
11177227|NCT02039726|BG001|Baseline|Salvage Chemotherapy|Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
10941555|NCT00765362|OG000|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
10941556|NCT00765362|EG000|Reported Event|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
10941557|NCT00765375|BG000|Baseline|Active on One Side and Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) on one side of face, and bacteriostatic saline solution on the other side of face.
10941558|NCT00765375|FG000|Participant Flow|Active on One Side, Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) treatment on one side of the face and bacteriostatic saline solution (Placebo) on the other side of the face.
10941559|NCT00765375|OG000|Outcome|1- Active|Botulinum Neurotoxin Type A (Botox)
10941560|NCT00765375|OG001|Outcome|2- Placebo|Saline Solution
10941561|NCT00765375|EG000|Reported Event|1- Active|Botulinum Neurotoxin Type A (Botox)
11177228|NCT02039726|BG002|Baseline|Total|Total of all reporting groups
11177229|NCT02039726|FG000|Participant Flow|Quizartinib|Participants who were randomized to receive 20 or 30 mg Quizartinib tablets administered orally once daily.
10941562|NCT00765375|EG001|Reported Event|2- Placebo|Saline Solution
10941563|NCT00765388|BG000|Baseline|Entire Study Population|Includes groups randomized to receive SenSura Uro first and Hollister Uro first
10941564|NCT00765388|FG000|Participant Flow|Hollister Uro First, Then SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
10941565|NCT00765388|FG001|Participant Flow|SenSura Uro First, Then Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
10941566|NCT00765388|OG000|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
10941567|NCT00765388|OG001|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
10941568|NCT00765388|EG000|Reported Event|Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
10941569|NCT00765388|EG001|Reported Event|SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
10941570|NCT00765570|BG000|Baseline|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
10941571|NCT00765570|BG001|Baseline|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
10941572|NCT00765570|BG002|Baseline|Total|Total of all reporting groups
10941573|NCT00765570|FG000|Participant Flow|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
11177230|NCT02039726|FG001|Participant Flow|Salvage Chemotherapy|Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
11177231|NCT02039726|OG000|Outcome|Quizartinib|Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily.
10941574|NCT00765570|FG001|Participant Flow|Treatment Group-2|Treatment Group 2:15 treatments with standard radiation
10941575|NCT00765570|OG000|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
10941576|NCT00765570|OG001|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
10941577|NCT00765570|EG000|Reported Event|Treatment Group 1|Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
10941578|NCT00765570|EG001|Reported Event|Treatment Group-2|Treatment Group 2-15 treatments with standard radiation
10941579|NCT00765648|BG000|Baseline|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
10941580|NCT00765648|BG001|Baseline|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
10941581|NCT00765648|BG002|Baseline|Total|Total of all reporting groups
10941582|NCT00765648|FG000|Participant Flow|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
10941583|NCT00765648|FG001|Participant Flow|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
10941584|NCT00765648|OG000|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
10941585|NCT00765648|OG001|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
10941586|NCT00765648|EG000|Reported Event|Nicardipine|Nicardipine dosing was 5 mg/hour
10941587|NCT00765648|EG001|Reported Event|Labetalol|Bolus Labetalol began at 20 mg over 2 minutes
10941588|NCT00765661|BG000|Baseline|Gorup A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~tacrolimus (Tacro™): LCP - Tacro™ tablets, orally"
10941589|NCT00765661|BG001|Baseline|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf®: Prograf® capsules, twice daily, orally"
10941590|NCT00765661|BG002|Baseline|Total|Total of all reporting groups
10941591|NCT00765661|FG000|Participant Flow|Group A|Randomized, parallel group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive LCP-Tacro tablets orally once daily (QD) in the morning, with an interval of 24 +/-1 hours between doses, starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg)
10941592|NCT00765661|FG001|Participant Flow|Group B|Randomized, parallel-group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of Prograf capsules in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive Prograf capsules in 2 equally divided doses, starting at 0.1 mg/kg every 12 hours (0.2 mg/kg total daily dose) as recommended in the U.S. Prescribing Information
10941593|NCT00765661|OG000|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
10941594|NCT00765661|OG001|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
10941595|NCT00765661|EG000|Reported Event|Group A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~tacrolimus (Tacro™): LCP - Tacro™ tablets"
10941596|NCT00765661|EG001|Reported Event|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf®: Prograf® capsules, twice daily"
10941597|NCT00765674|BG000|Baseline|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
10963449|NCT00872001|OG000|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB).
10941598|NCT00765674|BG001|Baseline|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
10941599|NCT00765674|BG002|Baseline|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
10941600|NCT00765674|BG003|Baseline|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
10941601|NCT00765674|BG004|Baseline|Total|Total of all reporting groups
10941602|NCT00765674|FG000|Participant Flow|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
10941603|NCT00765674|FG001|Participant Flow|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
10941604|NCT00765674|FG002|Participant Flow|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
10941605|NCT00765674|FG003|Participant Flow|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
10941606|NCT00765674|OG000|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
10941607|NCT00765674|OG001|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
10941608|NCT00765674|OG002|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
10941609|NCT00765674|OG003|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
10963450|NCT00872001|OG001|Outcome|Placebo|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB.
10963451|NCT00872001|OG000|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
10941610|NCT00765674|EG000|Reported Event|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
10941611|NCT00765674|EG001|Reported Event|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
10941612|NCT00765674|EG002|Reported Event|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
10941613|NCT00765674|EG003|Reported Event|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
10941614|NCT00765726|BG000|Baseline|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
10941615|NCT00765726|FG000|Participant Flow|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
10941616|NCT00765726|OG000|Outcome|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
10941617|NCT00765726|EG000|Reported Event|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
10941618|NCT00765817|BG000|Baseline|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
11177232|NCT02039726|OG001|Outcome|Salvage Chemotherapy|Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
10941619|NCT00765817|BG001|Baseline|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
10941620|NCT00765817|BG002|Baseline|Total|Total of all reporting groups
10941621|NCT00765817|FG000|Participant Flow|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
10941622|NCT00765817|FG001|Participant Flow|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
10941623|NCT00765817|OG000|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
10941624|NCT00765817|OG001|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
10941625|NCT00765817|EG000|Reported Event|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
10941626|NCT00765817|EG001|Reported Event|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
10941627|NCT00765843|BG000|Baseline|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941628|NCT00765843|BG001|Baseline|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941629|NCT00765843|BG002|Baseline|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941630|NCT00765843|BG003|Baseline|Total|Total of all reporting groups
11177233|NCT02039726|EG000|Reported Event|Quizartinib|Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily.
11341662|NCT03686033|EG002|Reported Event|Treatment C: E2082 25 mg|Participants received, E2082 25 mg tablet, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10941631|NCT00765843|FG000|Participant Flow|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941632|NCT00765843|FG001|Participant Flow|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941633|NCT00765843|FG002|Participant Flow|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941634|NCT00765843|OG000|Outcome|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941635|NCT00765843|OG001|Outcome|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941636|NCT00765843|OG002|Outcome|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941637|NCT00765843|EG000|Reported Event|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941638|NCT00765843|EG001|Reported Event|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941639|NCT00765843|EG002|Reported Event|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
10941640|NCT00765856|BG000|Baseline|Oxymorphone ER|Open-label dose titration period of up to 4 weeks and open-label maintenance period of up to 12 weeks.
10941641|NCT00765856|FG000|Participant Flow|Oxymorphone ER|Oxymorphone ER dosage was adjusted by investigator during the titration period. Study was terminated early by the Sponsor.
10941642|NCT00765856|OG000|Outcome|Titration Period|Open-label dose titration period of up to 4 weeks
10941643|NCT00765856|OG001|Outcome|Maintenance Period|Open-label maintenance period of up to 12 weeks
10941644|NCT00765856|OG000|Outcome|Titration Period|Open-label dose titration period of up to 4 weeks. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure
10941645|NCT00765856|EG000|Reported Event|Titration Period|Open-label dose titration period of up to 4 weeks
10941646|NCT00765856|EG001|Reported Event|Maintenance Period|Open-label maintenance period of up to 12 weeks plus 30 days post-last dose
10941647|NCT00765882|BG000|Baseline|Placebo|Dose matched placebo, oral administration, once per day.
10941648|NCT00765882|BG001|Baseline|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
10941649|NCT00765882|BG002|Baseline|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
10941650|NCT00765882|BG003|Baseline|Total|Total of all reporting groups
10941651|NCT00765882|FG000|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day.
10941652|NCT00765882|FG001|Participant Flow|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
10941653|NCT00765882|FG002|Participant Flow|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
10941654|NCT00765882|OG000|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
10941655|NCT00765882|OG001|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
10941656|NCT00765882|OG002|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
10941657|NCT00765882|EG000|Reported Event|Placebo|Dose matched placebo, oral administration, once per day.
10941658|NCT00765882|EG001|Reported Event|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
10941659|NCT00765882|EG002|Reported Event|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
10941660|NCT00765895|BG000|Baseline|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
10941661|NCT00765895|BG001|Baseline|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
10941662|NCT00765895|BG002|Baseline|Total|Total of all reporting groups
10941663|NCT00765895|FG000|Participant Flow|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
10941664|NCT00765895|FG001|Participant Flow|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
10941665|NCT00765895|OG000|Outcome|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
10941666|NCT00765895|OG001|Outcome|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
10941667|NCT00765895|EG000|Reported Event|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
10941668|NCT00765895|EG001|Reported Event|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
10941669|NCT00765947|BG000|Baseline|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
10941670|NCT00765947|FG000|Participant Flow|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
10941671|NCT00765947|OG000|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
10941672|NCT00765947|EG000|Reported Event|Aliskiren|Aliskiren treatment step
10941673|NCT00765947|EG001|Reported Event|Aliskiren + HCTZ|Aliskiren and HCTZ treatment step
10941674|NCT00765947|EG002|Reported Event|Aliskiren + HCTZ + Amlodipine|Aliskiren + HCTZ + Amlodipine treatment step
10941675|NCT00765999|BG000|Baseline|Linaclotide|Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced adverse events (AEs) intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
10941676|NCT00765999|FG000|Participant Flow|Linaclotide|Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced adverse events (AEs) intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
10941677|NCT00765999|OG000|Outcome|Linaclotide (CC)|Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with CC. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, paticipants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
10941678|NCT00765999|OG001|Outcome|Linaclotide (IBS-C)|Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
10941679|NCT00765999|EG000|Reported Event|Linaclotide (CC)|Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with CC. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
10941680|NCT00765999|EG001|Reported Event|Linaclotide (IBS-C)|Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
10963452|NCT00872001|OG001|Outcome|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
10941681|NCT00766038|BG000|Baseline|Treatment With Recombinant Human Growth Hormone|"The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.~Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements"
10941682|NCT00766038|BG001|Baseline|Placebo Treatment|"Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.~Placebo: SC injection daily"
10941683|NCT00766038|BG002|Baseline|Total|Total of all reporting groups
10941684|NCT00766038|FG000|Participant Flow|Active Treatment With Recombinant Human Growth Hormone|"The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.~Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements"
10941685|NCT00766038|FG001|Participant Flow|Placebo Treatment|"Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.~Placebo: SC injection daily"
10941686|NCT00766038|OG000|Outcome|rhGH Treatment|"The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.~Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements"
10941687|NCT00766038|OG001|Outcome|Placebo Treament|"Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.~Placebo: SC injection daily"
10941688|NCT00766038|OG000|Outcome|Active Treatment With Recombinant Human Growth Hormone|"The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.~Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements"
10941689|NCT00766038|OG001|Outcome|Placebo Treatment|"Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.~Placebo: SC injection daily"
11177234|NCT02039726|EG001|Reported Event|Salvage Chemotherapy|Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
10941690|NCT00766038|EG000|Reported Event|Recombinant Human Growth Hormone|"The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.~Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements"
10941691|NCT00766038|EG001|Reported Event|Placebo Treatment|"Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.~Placebo: SC injection daily"
10941692|NCT00766051|BG000|Baseline|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee (1978) and consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
10941693|NCT00766051|BG001|Baseline|Intervention Group|This is the only Matched Historical Comparison group infants that the analysis refer to. The intervention group consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
10941694|NCT00766051|BG002|Baseline|Total|Total of all reporting groups
10941695|NCT00766051|FG000|Participant Flow|Intervention Group|This is the only intervention group that the analysis apply to.
10941696|NCT00766051|FG001|Participant Flow|Matched Historical Comparison Group|Matched Historical Controls drawn from a three year period.
10941697|NCT00766051|OG000|Outcome|Intervention Group|This is the only intervention group that the analysis apply to. The intervention and the matched historical comparison group consisted of preterm, near term and full term infants with feeding problems.
10941698|NCT00766051|OG001|Outcome|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee, (1978).
10941699|NCT00766051|OG000|Outcome|Intervention Group|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
10941700|NCT00766051|OG000|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
10941701|NCT00766051|OG001|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
10941702|NCT00766051|EG000|Reported Event|Intervention Group|This is the only intervention group that the analysis apply to.
10941703|NCT00766090|BG000|Baseline|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941704|NCT00766090|BG001|Baseline|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941705|NCT00766090|BG002|Baseline|Total|Total of all reporting groups
10941706|NCT00766090|FG000|Participant Flow|Sequence 1: Placebo, FF 200 µg, FF 100 µg|Participants received placebo twice daily (BID), fluticasone furoate (FF) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FF 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941707|NCT00766090|FG001|Participant Flow|Sequence 2: Placebo, FF 100 µg, FF 200 µg|Participants received placebo BID, FF 100 µg inhalation powder BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941708|NCT00766090|FG002|Participant Flow|Sequence 3: FF 100 µg, Placebo, FF 200 µg|Participants received FF 100 µg inhalation powder BID, placebo BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941709|NCT00766090|FG003|Participant Flow|Sequence 4: FF 100 µg, FF 200 µg, Placebo|Participants received FF 100 µg inhalation powder BID, FF 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941710|NCT00766090|FG004|Participant Flow|Sequence 5: FF 200 µg, Placebo, FF 100 µg|Participants received FF 200 µg inhalation powder OD in the evening, placebo BID, and FF 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941711|NCT00766090|FG005|Participant Flow|Sequence 6: FF 200 µg, FF 100 µg, Placebo|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941712|NCT00766090|FG006|Participant Flow|Sequence 7: Placebo, FP 200 µg, FP 100 µg|Participants received placebo twice daily (BID), fluticasone propionate (FP) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FP 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941713|NCT00766090|FG007|Participant Flow|Sequence 8: Placebo, FP 100 µg, FP 200 µg|Participants received placebo BID, FP 100 µg inhalation powder BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941714|NCT00766090|FG008|Participant Flow|Sequence 9: FP 100 µg, Placebo, FP 200 µg|Participants received FP 100 µg inhalation powder BID, placebo BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941715|NCT00766090|FG009|Participant Flow|Sequence 10: FP 100 µg, FP 200 µg, Placebo|Participants received FP 100 µg inhalation powder BID, FP 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941716|NCT00766090|FG010|Participant Flow|Sequence 11: FP 200 µg, Placebo, FP 100 µg|Participants received FP 200 µg inhalation powder OD in the evening, placebo BID, and FP 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941717|NCT00766090|FG011|Participant Flow|Sequence 12: FP 200 µg, FP 100 µg, Placebo|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941718|NCT00766090|OG000|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941719|NCT00766090|OG001|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941720|NCT00766090|OG002|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941721|NCT00766090|OG003|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941722|NCT00766090|OG004|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941723|NCT00766090|OG000|Outcome|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941724|NCT00766090|OG001|Outcome|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941725|NCT00766090|EG000|Reported Event|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941726|NCT00766090|EG001|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941727|NCT00766090|EG002|Reported Event|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941728|NCT00766090|EG003|Reported Event|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941729|NCT00766090|EG004|Reported Event|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
10941730|NCT00766116|BG000|Baseline|Treatment|"5-Azacitidine, Gemtuzumab ozogamicin~5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit~Gemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks"
10941731|NCT00766116|FG000|Participant Flow|Treatment|"5-Azacitidine, Gemtuzumab ozogamicin~5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit~Gemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks"
10941732|NCT00766116|OG000|Outcome|Phase 1 Cohort 1|5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 2 days
10941733|NCT00766116|OG001|Outcome|Phase 1 Cohort 2|5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 4 days
10941734|NCT00766116|OG002|Outcome|Phase 1 Cohort 3|5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 6 days
10941735|NCT00766116|OG000|Outcome|Treatment|"5-Azacitidine, Gemtuzumab ozogamicin~5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit~Gemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks"
10941736|NCT00766116|EG000|Reported Event|Treatment|"5-Azacitidine, Gemtuzumab ozogamicin~5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit~Gemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks"
10941737|NCT00766142|BG000|Baseline|Chemotherapy + Cetuximab|"Cetuximab 500 mg/m² IV~Oxaliplatine 85 mg/m² IV~L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV~5-FU bolus 400 mg/m² IV~5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles."
10941738|NCT00766142|FG000|Participant Flow|Chemotherapy + Cetuximab|"Cetuximab 500 mg/m² IV~Oxaliplatine 85 mg/m² IV~L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV~5-FU bolus 400 mg/m² IV~5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles."
10941739|NCT00766142|OG000|Outcome|Chemotherapy + Cetuximab|"Cetuximab 500 mg/m² IV~Oxaliplatine 85 mg/m² IV~L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV~5-FU bolus 400 mg/m² IV~5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles."
10941740|NCT00766142|EG000|Reported Event|Chemotherapy + Cetuximab|"cetuximab~fluorouracil~leucovorin calcium~oxaliplatin~adjuvant therapy~therapeutic conventional surgery"
10941741|NCT00766363|BG000|Baseline|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
10941742|NCT00766363|BG001|Baseline|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
10941743|NCT00766363|BG002|Baseline|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
10941744|NCT00766363|BG003|Baseline|Placebo|1 capsule per day for 28 days.
10941745|NCT00766363|BG004|Baseline|Total|Total of all reporting groups
10941746|NCT00766363|FG000|Participant Flow|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
10941747|NCT00766363|FG001|Participant Flow|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
10941748|NCT00766363|FG002|Participant Flow|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
10941749|NCT00766363|FG003|Participant Flow|Placebo|1 capsule per day for 28 days.
10941750|NCT00766363|OG000|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
10941751|NCT00766363|OG001|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
10941752|NCT00766363|OG002|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
10941753|NCT00766363|OG003|Outcome|Placebo|1 capsule per day for 28 days.
10941754|NCT00766363|OG001|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
10941755|NCT00766363|EG000|Reported Event|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
10941756|NCT00766363|EG001|Reported Event|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
10941757|NCT00766363|EG002|Reported Event|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
10941758|NCT00766363|EG003|Reported Event|Placebo|1 capsule per day for 28 days.
10941759|NCT00766376|BG000|Baseline|Erbium Laser|Each subject will undergo a minimum of 1 treatment with 5 scheduled follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
10941760|NCT00766376|FG000|Participant Flow|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
10941761|NCT00766376|OG000|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
10941762|NCT00766376|EG000|Reported Event|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
10941763|NCT00766415|BG000|Baseline|AZD1981|AZD1981 1000 mg, twice daily
10941764|NCT00766415|BG001|Baseline|Placebo|Placebo, twice daily
10941765|NCT00766415|BG002|Baseline|Total|Total of all reporting groups
10941766|NCT00766415|FG000|Participant Flow|AZD1981|AZD1981 1000 mg, twice daily
10941767|NCT00766415|FG001|Participant Flow|Placebo|Placebo, twice daily
10941768|NCT00766415|OG000|Outcome|AZD1981|AZD1981 1000 mg, twice daily
10941769|NCT00766415|OG001|Outcome|Placebo|Placebo, twice daily
10941770|NCT00766415|EG000|Reported Event|AZD1981|AZD1981 1000 mg, twice daily
10941771|NCT00766415|EG001|Reported Event|Placebo|Placebo, twice daily
10941772|NCT00766467|BG000|Baseline|Armodafinil|Armodafinil: Taken orally once a day in the morning.
10941773|NCT00766467|BG001|Baseline|Placebo|Placebo: Taken orally once a day in the morning.
10941774|NCT00766467|BG002|Baseline|Total|Total of all reporting groups
10941775|NCT00766467|FG000|Participant Flow|Armodafinil|Armodafinil: 150mg taken orally once a day in the morning.
10941776|NCT00766467|FG001|Participant Flow|Placebo|Placebo: Taken orally once a day in the morning
10941777|NCT00766467|OG000|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
10941778|NCT00766467|OG001|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
10941779|NCT00766467|EG000|Reported Event|Armodafinil|Armodafinil: Taken orally once a day in the morning.
10941780|NCT00766467|EG001|Reported Event|Placebo|Placebo: Taken orally once a day in the morning.
10941781|NCT00766493|BG000|Baseline|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
10941782|NCT00766493|FG000|Participant Flow|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
10941783|NCT00766493|OG000|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
10941784|NCT00766493|EG000|Reported Event|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
10941785|NCT00766506|BG000|Baseline|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
10941786|NCT00766506|BG001|Baseline|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
10941787|NCT00766506|BG002|Baseline|Total|Total of all reporting groups
10963453|NCT00872001|EG000|Reported Event|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
10941788|NCT00766506|FG000|Participant Flow|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
10941789|NCT00766506|FG001|Participant Flow|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
10941790|NCT00766506|OG000|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
10941791|NCT00766506|OG001|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
10941792|NCT00766506|EG000|Reported Event|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
10941793|NCT00766506|EG001|Reported Event|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
10941794|NCT00766532|BG000|Baseline|Group 1|
10941795|NCT00766532|FG000|Participant Flow|Arm Title- Aromatase Inhibitor Therapy|calcium absorption was measured among subjects at baseline and after taking aromatase inhibitor therapy.
10941796|NCT00766532|OG000|Outcome|Aromatase Inhibitor Therapy|
11177235|NCT02039778|BG000|Baseline|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
10941797|NCT00766532|EG000|Reported Event|Group 1|
10941798|NCT00766597|BG000|Baseline|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
10941799|NCT00766597|FG000|Participant Flow|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
10941800|NCT00766597|OG000|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic virus
10941801|NCT00766597|OG000|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
10941802|NCT00766597|OG000|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
10941803|NCT00766597|EG000|Reported Event|Vicriviroc in Tablet Form (20/30mg) or Liquid Form (1mg/ml)|Drug: Vicriviroc Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen
10941804|NCT00766649|BG000|Baseline|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
10941805|NCT00766649|FG000|Participant Flow|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
10941806|NCT00766649|OG000|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
10941807|NCT00766649|EG000|Reported Event|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
10941808|NCT00766675|BG000|Baseline|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
10941809|NCT00766675|FG000|Participant Flow|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
10941810|NCT00766675|OG000|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
10941811|NCT00766675|EG000|Reported Event|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
10963454|NCT00872001|EG001|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
11177236|NCT02039778|FG000|Participant Flow|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
10941812|NCT00766727|BG000|Baseline|All Participants|"The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC).~For example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side."
10941813|NCT00766727|FG000|Participant Flow|All Participants|"The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC).~For example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side."
10941814|NCT00766727|OG000|Outcome|GLYDe Dressing (Treated)|"The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC).~For example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side."
10941815|NCT00766727|OG001|Outcome|SoC (Control)|Standard of care treatment group, used as the control. The opposite side of the intervention received the standard of care (SoC). For example, one patient wore a GLYDe Dressing on Left Side, and SoC on Right Side while another patient wore GLYDe Dressing Right Side, and SoC on Left Side.
10941816|NCT00766727|EG000|Reported Event|GLYDe Dressing|"Investigational Dressing~GLYDe Dressing: Wound dressing intended to minimize scar formation"
10941817|NCT00766727|EG001|Reported Event|Standard of Care|Standard of care comparator
10941818|NCT00766753|BG000|Baseline|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
10941819|NCT00766753|BG001|Baseline|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
10941820|NCT00766753|BG002|Baseline|Total|Total of all reporting groups
10941821|NCT00766753|FG000|Participant Flow|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
10941822|NCT00766753|FG001|Participant Flow|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
10941823|NCT00766753|OG000|Outcome|AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
11177237|NCT02039778|OG000|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
10941824|NCT00766753|OG001|Outcome|AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
10941825|NCT00766753|OG000|Outcome|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
10941826|NCT00766753|OG001|Outcome|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
10941827|NCT00766753|EG000|Reported Event|Alpha DC1 Vaccine + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine, up to 4 vaccines
10941828|NCT00766831|BG000|Baseline|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
10941829|NCT00766831|FG000|Participant Flow|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
10941830|NCT00766831|OG000|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
10941831|NCT00766831|EG000|Reported Event|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
10941832|NCT00767000|BG000|Baseline|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
10941833|NCT00767000|BG001|Baseline|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
10941834|NCT00767000|BG002|Baseline|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
10941835|NCT00767000|BG003|Baseline|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
10941836|NCT00767000|BG004|Baseline|Placebo|Placebo three times daily plus insulin once daily with or without metformin
10941837|NCT00767000|BG005|Baseline|Total|Total of all reporting groups
10941838|NCT00767000|FG000|Participant Flow|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
11177238|NCT02039778|EG000|Reported Event|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
10941839|NCT00767000|FG001|Participant Flow|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
10941840|NCT00767000|FG002|Participant Flow|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
10941841|NCT00767000|FG003|Participant Flow|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
10941842|NCT00767000|FG004|Participant Flow|Placebo|Placebo three times daily plus insulin once daily with or without metformin
10941843|NCT00767000|OG000|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
10941844|NCT00767000|OG001|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
10941845|NCT00767000|OG002|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
10941846|NCT00767000|OG003|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
10941847|NCT00767000|OG004|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
10941848|NCT00767000|EG000|Reported Event|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
10941849|NCT00767000|EG001|Reported Event|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
10941850|NCT00767000|EG002|Reported Event|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
10941851|NCT00767000|EG003|Reported Event|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
10941852|NCT00767000|EG004|Reported Event|Placebo|Placebo three times daily plus insulin once daily with or without metformin
10941853|NCT00767039|BG000|Baseline|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
10941854|NCT00767039|BG001|Baseline|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
10941855|NCT00767039|BG002|Baseline|Total|Total of all reporting groups
10941856|NCT00767039|FG000|Participant Flow|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
10941857|NCT00767039|FG001|Participant Flow|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
10941858|NCT00767039|OG000|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
10941859|NCT00767039|OG001|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
10941860|NCT00767039|EG000|Reported Event|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
10941861|NCT00767039|EG001|Reported Event|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
10941862|NCT00767104|BG000|Baseline|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
10941863|NCT00767104|BG001|Baseline|Control Pillowcase|placebo pillowcase made of 100% cotton
10941864|NCT00767104|BG002|Baseline|Total|Total of all reporting groups
10941865|NCT00767104|FG000|Participant Flow|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
10941866|NCT00767104|FG001|Participant Flow|Control Pillowcase|placebo pillowcase made of 100% cotton
10941867|NCT00767104|OG000|Outcome|Experimental Silk-like Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
10941868|NCT00767104|OG001|Outcome|Control Cotton Pillowcase|placebo pillowcase made of 100% cotton
10941869|NCT00767104|OG000|Outcome|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
10941870|NCT00767104|OG001|Outcome|Control Pillowcase|placebo pillowcase made of 100% cotton
10941871|NCT00767104|EG000|Reported Event|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
10941872|NCT00767104|EG001|Reported Event|Control Pillowcase|placebo pillowcase made of 100% cotton
10941873|NCT00767325|BG000|Baseline|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
10941874|NCT00767325|FG000|Participant Flow|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
10941875|NCT00767325|OG000|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
10941876|NCT00767325|EG000|Reported Event|Aba 10 mg/kg|
10941877|NCT00767338|BG000|Baseline|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
10941878|NCT00767338|BG001|Baseline|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
10941879|NCT00767338|BG002|Baseline|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
10941880|NCT00767338|BG003|Baseline|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
10941881|NCT00767338|BG004|Baseline|Total|Total of all reporting groups
10941882|NCT00767338|FG000|Participant Flow|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
10941883|NCT00767338|FG001|Participant Flow|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
10941884|NCT00767338|FG002|Participant Flow|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
10941885|NCT00767338|FG003|Participant Flow|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
10941886|NCT00767338|OG000|Outcome|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
10941887|NCT00767338|OG001|Outcome|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
10941888|NCT00767338|OG002|Outcome|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
10941889|NCT00767338|OG003|Outcome|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
10941890|NCT00767338|EG000|Reported Event|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
10941891|NCT00767338|EG001|Reported Event|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
10941892|NCT00767338|EG002|Reported Event|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
10941893|NCT00767338|EG003|Reported Event|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
10941894|NCT00767364|BG000|Baseline|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
10941895|NCT00767364|BG001|Baseline|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
10941896|NCT00767364|BG002|Baseline|Total|Total of all reporting groups
10941897|NCT00767364|FG000|Participant Flow|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
10941898|NCT00767364|FG001|Participant Flow|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
10941899|NCT00767364|OG000|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
10941900|NCT00767364|OG001|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
10941901|NCT00767364|EG000|Reported Event|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
10941902|NCT00767364|EG001|Reported Event|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
10941903|NCT00767455|BG000|Baseline|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
10941904|NCT00767455|FG000|Participant Flow|HP828-101 vs. Negative Control vs. Positive Control|Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)
10941905|NCT00767455|OG000|Outcome|HP828-101|Intervention test article
11177239|NCT02039817|BG000|Baseline|Healthy Volunteers|Health Volunteers received one 50mg dose of IDN-6556
10941906|NCT00767455|OG001|Outcome|Negative Control|Johnson's Baby Oil
10941907|NCT00767455|OG002|Outcome|Positive Control|Sodium Lauryl Sulfate
10941908|NCT00767455|EG000|Reported Event|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
10941909|NCT00767507|BG000|Baseline|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941910|NCT00767507|BG001|Baseline|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941911|NCT00767507|BG002|Baseline|Stage II Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941912|NCT00767507|BG003|Baseline|Stage II Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941913|NCT00767507|BG004|Baseline|Total|Total of all reporting groups
10941914|NCT00767507|FG000|Participant Flow|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941915|NCT00767507|FG001|Participant Flow|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941916|NCT00767507|FG002|Participant Flow|Stage II - Cangrelor Arm (0.75 mcg/kg/Min )|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941917|NCT00767507|FG003|Participant Flow|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941918|NCT00767507|OG000|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941919|NCT00767507|OG001|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941920|NCT00767507|OG000|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941921|NCT00767507|OG001|Outcome|Stage II - Placebo Arm|Patients who received m as a matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941922|NCT00767507|OG001|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941923|NCT00767507|OG002|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941924|NCT00767507|OG003|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941925|NCT00767507|OG000|Outcome|Stage II - Cangrelor (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941926|NCT00767507|OG002|Outcome|Stage I, Cohort 1 - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941927|NCT00767507|OG002|Outcome|Stage I, Cohort 1 - Cangrelor (0.5 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
11177240|NCT02039817|BG001|Baseline|Severe Renal Impairment|Severe Renal Impairment subjects received one 50mg dose of IDN-6556
11177241|NCT02039817|BG002|Baseline|Total|Total of all reporting groups
11177242|NCT02039817|FG000|Participant Flow|Healthy Volumteers|Healthy volunteers were given a single 50mg dose of IDN-6556
11177243|NCT02039817|FG001|Participant Flow|Severe Renal Impairment|Severe Renal Impairment subjects were given a single 50mg dose of IDN-6556
10941928|NCT00767507|OG003|Outcome|Stage I - Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941929|NCT00767507|EG000|Reported Event|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941930|NCT00767507|EG001|Reported Event|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941931|NCT00767507|EG002|Reported Event|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941932|NCT00767507|EG003|Reported Event|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
10941933|NCT00767520|BG000|Baseline|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
10941934|NCT00767520|BG001|Baseline|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
10941935|NCT00767520|BG002|Baseline|Total|Total of all reporting groups
10941936|NCT00767520|FG000|Participant Flow|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
10941937|NCT00767520|FG001|Participant Flow|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
10941938|NCT00767520|OG000|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
10941939|NCT00767520|OG001|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
10941940|NCT00767520|EG000|Reported Event|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
10941941|NCT00767520|EG001|Reported Event|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
10941942|NCT00767572|BG000|Baseline|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomly assigned to receive atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment were performed before and after each 12 week intervention.
10941943|NCT00767572|FG000|Participant Flow|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomized to atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment was performed before and after each 12 week intervention.
10941944|NCT00767572|OG000|Outcome|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks.
10941945|NCT00767572|OG001|Outcome|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
10941946|NCT00767572|EG000|Reported Event|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy.
10941947|NCT00767572|EG001|Reported Event|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
10941948|NCT00767624|BG000|Baseline|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
10941949|NCT00767624|BG001|Baseline|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
10941950|NCT00767624|BG002|Baseline|Total|Total of all reporting groups
10941951|NCT00767624|FG000|Participant Flow|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
10941952|NCT00767624|FG001|Participant Flow|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
10941953|NCT00767624|OG000|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
10941954|NCT00767624|OG001|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
10941955|NCT00767624|EG000|Reported Event|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
10941956|NCT00767624|EG001|Reported Event|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
10941957|NCT00767676|BG000|Baseline|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
10941958|NCT00767676|FG000|Participant Flow|HP828-101|HP828-101 : Nine topical patch applications, each the approximate size of a nickel, over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
10941959|NCT00767676|OG000|Outcome|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
10941960|NCT00767676|EG000|Reported Event|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
10941961|NCT00767767|BG000|Baseline|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
10941962|NCT00767767|BG001|Baseline|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
10941963|NCT00767767|BG002|Baseline|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours."
10941964|NCT00767767|BG003|Baseline|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
10941965|NCT00767767|BG004|Baseline|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
10941966|NCT00767767|BG005|Baseline|Total|Total of all reporting groups
10941967|NCT00767767|FG000|Participant Flow|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
10941968|NCT00767767|FG001|Participant Flow|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
10941969|NCT00767767|FG002|Participant Flow|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propofol infusion for 2 hours."
10941970|NCT00767767|FG003|Participant Flow|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
10941971|NCT00767767|FG004|Participant Flow|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
10941972|NCT00767767|OG000|Outcome|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
10941973|NCT00767767|OG001|Outcome|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
10941974|NCT00767767|OG002|Outcome|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours."
10941975|NCT00767767|OG003|Outcome|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
10941976|NCT00767767|OG004|Outcome|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
10941977|NCT00767767|EG000|Reported Event|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
10941978|NCT00767767|EG001|Reported Event|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
10941979|NCT00767767|EG002|Reported Event|Propofol 0.90mcg/mL|"Anesthetic Drug Infusion~Propofol 0.90mcg/mL: IV Propofol infusion for 2 hours."
10941980|NCT00767767|EG003|Reported Event|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental 1.5mcg/mL infusion for 2 hours"
10941981|NCT00767767|EG004|Reported Event|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental 3mcg/mL infusion for 2 hours"
10941982|NCT00767806|BG000|Baseline|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
10941983|NCT00767806|BG001|Baseline|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
10941984|NCT00767806|BG002|Baseline|Total|Total of all reporting groups
10941985|NCT00767806|FG000|Participant Flow|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
10941986|NCT00767806|FG001|Participant Flow|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
10941987|NCT00767806|OG000|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
10941988|NCT00767806|OG001|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
10941989|NCT00767806|EG000|Reported Event|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
10941990|NCT00767806|EG001|Reported Event|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
10941991|NCT00767819|BG000|Baseline|Arm 1|Progressive or metastatic bone or soft tissue sarcomas
10941992|NCT00767819|BG001|Baseline|Arm 2|Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line
10941993|NCT00767819|BG002|Baseline|Arm 3|Progressive or metastatic alveolar soft part sarcoma (ASPS)
10941994|NCT00767819|BG003|Baseline|Total|Total of all reporting groups
10941995|NCT00767819|FG000|Participant Flow|Arm 1|Progressive or metastatic bone or soft tissue sarcomas
10941996|NCT00767819|FG001|Participant Flow|Arm 2|Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line
10941997|NCT00767819|FG002|Participant Flow|Arm 3|Progressive or metastatic alveolar soft part sarcoma (ASPS)
10941998|NCT00767819|OG000|Outcome|Arm 1|Progressive or metastatic bone or soft tissue sarcomas
10941999|NCT00767819|OG001|Outcome|Arm 2|Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line
10942000|NCT00767819|OG002|Outcome|Arm 3|Progressive or metastatic alveolar soft part sarcoma (ASPS)
10942001|NCT00767819|EG000|Reported Event|Arm I|Progressive or metastatic bone or soft tissue sarcomas
10942002|NCT00767819|EG001|Reported Event|Arm II|Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line
10942003|NCT00767819|EG002|Reported Event|Arm III|Progressive or metastatic alveolar soft part sarcoma (ASPS)
10942004|NCT00768053|BG000|Baseline|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
10942005|NCT00768053|FG000|Participant Flow|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
10942006|NCT00768053|OG000|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
10942007|NCT00768053|EG000|Reported Event|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
10942008|NCT00768066|BG000|Baseline|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942009|NCT00768066|BG001|Baseline|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942010|NCT00768066|BG002|Baseline|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942011|NCT00768066|BG003|Baseline|Total|Total of all reporting groups
10942012|NCT00768066|FG000|Participant Flow|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942013|NCT00768066|FG001|Participant Flow|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942014|NCT00768066|FG002|Participant Flow|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942015|NCT00768066|OG000|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942016|NCT00768066|OG001|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942017|NCT00768066|OG002|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942018|NCT00768066|EG000|Reported Event|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942019|NCT00768066|EG001|Reported Event|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942020|NCT00768066|EG002|Reported Event|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
10942021|NCT00768079|BG000|Baseline|Placebo|A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
10942022|NCT00768079|BG001|Baseline|Benralizumab 0.3 mg/kg|A single dose of benralizumab (MEDI-563) 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion over at least 30 minutes on Day 0.
11177244|NCT02039817|OG000|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
10942023|NCT00768079|BG002|Baseline|Benralizumab 1.0 mg/kg|A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
10942024|NCT00768079|BG003|Baseline|Total|Total of all reporting groups
10942025|NCT00768079|FG000|Participant Flow|Placebo|A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
10942026|NCT00768079|FG001|Participant Flow|Benralizumab 0.3 mg/kg|A single dose of benralizumab (MEDI-563) 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion over at least 30 minutes on Day 0.
10942027|NCT00768079|FG002|Participant Flow|Benralizumab 1.0 mg/kg|A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
10942028|NCT00768079|OG000|Outcome|Placebo|A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
10942029|NCT00768079|OG001|Outcome|Benralizumab 0.3 mg/kg|A single dose of benralizumab (MEDI-563) 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion over at least 30 minutes on Day 0.
11177245|NCT02039817|OG001|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
11177246|NCT02039817|EG000|Reported Event|IDN-6556|A single 50mg dose of IDN-6556
11177247|NCT02039856|BG000|Baseline|EBQI-Supported WH-PACT Implementation|Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.
10942030|NCT00768079|OG002|Outcome|Benralizumab 1.0 mg/kg|A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
10942031|NCT00768079|OG000|Outcome|Benralizumab 0.3 mg/kg|A single dose of benralizumab (MEDI-563) 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion over at least 30 minutes on Day 0.
10942032|NCT00768079|OG001|Outcome|Benralizumab 1.0 mg/kg|A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
10942033|NCT00768079|EG000|Reported Event|Placebo|A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
10942034|NCT00768079|EG001|Reported Event|Benralizumab 0.3 mg/kg|A single dose of benralizumab (MEDI-563) 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion over at least 30 minutes on Day 0.
10942035|NCT00768079|EG002|Reported Event|Benralizumab 1.0 mg/kg|A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
10942036|NCT00768118|BG000|Baseline|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
10942037|NCT00768118|FG000|Participant Flow|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
10942038|NCT00768118|OG000|Outcome|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
10942039|NCT00768118|EG000|Reported Event|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
10942040|NCT00768144|BG000|Baseline|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
10942041|NCT00768144|FG000|Participant Flow|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
10942042|NCT00768144|OG000|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
10942043|NCT00768144|EG000|Reported Event|Sunitinib|Sunitinib : Taken orally once a day in the evening
10942044|NCT00768222|BG000|Baseline|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
10942045|NCT00768222|BG001|Baseline|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
10942046|NCT00768222|BG002|Baseline|Total|Total of all reporting groups
10942047|NCT00768222|FG000|Participant Flow|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
10942048|NCT00768222|FG001|Participant Flow|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
10942049|NCT00768222|OG000|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
10942050|NCT00768222|OG001|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
10942051|NCT00768222|EG000|Reported Event|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
10942052|NCT00768222|EG001|Reported Event|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
10942053|NCT00768261|BG000|Baseline|1 Very Mild to Mild DAT Untreated|Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine
10942054|NCT00768261|BG001|Baseline|2 Very Mild to Mild DAT Treated With Donepezil|"Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.~Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy."
10942055|NCT00768261|BG002|Baseline|3 Very Mild to Mild DAT Treated With the Combination|"Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.~Memantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.~Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects"
10942056|NCT00768261|BG003|Baseline|4 Nondemented Comparison Subjects.|Group 4) nondemented comparison subjects.
10942057|NCT00768261|BG004|Baseline|Total|Total of all reporting groups
10942058|NCT00768261|FG000|Participant Flow|1 Very Mild to Mild DAT Untreated|Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine
10942059|NCT00768261|FG001|Participant Flow|2 Very Mild to Mild DAT Treated With Donepezil|"Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.~Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy."
10942060|NCT00768261|FG002|Participant Flow|3 Very Mild to Mild DAT Treated With the Combination|"Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.~Memantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.~Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects"
10942061|NCT00768261|FG003|Participant Flow|4 Nondemented Comparison Subjects.|Group 4) nondemented comparison subjects.
10942062|NCT00768261|OG000|Outcome|1 Very Mild to Mild DAT Untreated|Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine
10942063|NCT00768261|OG001|Outcome|2 Very Mild to Mild DAT Treated With Donepezil|"Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.~Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy."
10942064|NCT00768261|OG002|Outcome|3 Very Mild to Mild DAT Treated With the Combination|"Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.~Memantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.~Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects"
10942065|NCT00768261|OG003|Outcome|4 Nondemented Comparison Subjects.|Group 4) nondemented comparison subjects.
10942066|NCT00768261|OG000|Outcome|Improved|Response group by ADAS-Cog rates
10942067|NCT00768261|OG001|Outcome|Worsening|Response group by ADAS-Cog rates
10942068|NCT00768261|OG002|Outcome|Stable|Response group by ADAS-Cog rates
10942069|NCT00768261|EG000|Reported Event|1 Very Mild to Mild DAT Untreated|Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine
10942070|NCT00768261|EG001|Reported Event|2 Very Mild to Mild DAT Treated With Donepezil|"Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.~Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy."
10942071|NCT00768261|EG002|Reported Event|3 Very Mild to Mild DAT Treated With the Combination|"Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.~Memantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.~Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects"
10942072|NCT00768261|EG003|Reported Event|4 Nondemented Comparison Subjects.|Group 4) nondemented comparison subjects.
10942073|NCT00768287|BG000|Baseline|IB1001 Safety Population|Study Population exposed to at least one infusion of IB1001.
10942074|NCT00768287|FG000|Participant Flow|PK: IB1001 First, Then Nonacog Alfa|Pharmacokinetic Study: Randomized, double-blind, cross-over study
10942075|NCT00768287|FG001|Participant Flow|PK: Nonacog Alfa First, Then IB1001|Pharmacokinetic Study: Randomized, double-blind, cross-over study
10942076|NCT00768287|FG002|Participant Flow|Repeat IB1001 PK|Repeat Pharmacokinetic Study: Non-randomized, open-label study
10942077|NCT00768287|FG003|Participant Flow|IB1001 Prophylaxis|Treatment Study: Non-randomized, open-label study
10942078|NCT00768287|FG004|Participant Flow|IB1001 On Demand|Treatment Study: Non-randomized, open-label study
10942079|NCT00768287|FG005|Participant Flow|IB1001 Surgical Substudy|Surgical Substudy: Non-randomized, open-label study
10942080|NCT00768287|OG000|Outcome|IB1001 (On Demand)|IB1001 50-100 IU/kg at the time of a bleeding episode
10942081|NCT00768287|OG001|Outcome|IB1001 (Prophylaxis)|IB1001 50-75 IU/kg twice a week
10942082|NCT00768287|OG000|Outcome|IB1001|IB1001 75 ± 5 IU/kg
10942083|NCT00768287|OG001|Outcome|Nonacog Alfa|nonacog alfa 75 ± 5 IU/kg
10942084|NCT00768287|OG002|Outcome|Repeat IB1001|Repeat PK study of IB1001 75 ± 5 IU/kg 3.1 to 18.6 (median 5.8) months following initial PK study
10942085|NCT00768287|OG000|Outcome|IB1001 - Surgical Substudy|"IB1001 Bolus Regimen: 120 IU/kg prior to start of procedure, followed by 60 IU/kg 12 hours after the first infusion, and up to 120 IU/kg 24 hours after the first infusion. Bolus infusions continue every 12 hours for a minimum of 3 days; or~IB1001 Continuous Infusion Regimen: IB1001 infused at a target range of 70% to 110% for a minimum of 3 days post-procedure."
10942086|NCT00768287|OG000|Outcome|IB1001 (12 Hours) - Surgical Substudy|"Hemostasis 12 hours following surgery;~IB1001 Bolus Regimen: 120 IU/kg prior to start of procedure, followed by 60 IU/kg 12 hours after the first infusion, and up to 120 IU/kg 24 hours after the first infusion. Bolus infusions would continue every 12 hours for a minimum of 3 days; or~IB1001 Continuous Infusion Regimen: IB1001 infused at a target range of 70% to 110% for a minimum of 3 days post-procedure."
10942087|NCT00768287|OG001|Outcome|IB1001 (24 Hours) - Surgical Substudy|"Hemostasis 24 hours following surgery;~IB1001 Bolus Regimen: 120 IU/kg prior to start of procedure, followed by 60 IU/kg 12 hours after the first infusion, and up to 120 IU/kg 24 hours after the first infusion. Bolus infusions would continue every 12 hours for a minimum of 3 days; or~IB1001 Continuous Infusion Regimen: IB1001 infused at a target range of 70% to 110% for a minimum of 3 days post-procedure."
10942088|NCT00768287|OG000|Outcome|IB1001 - Surgical Substudy|"IB1001 Bolus Regimen: 120 IU/kg prior to start of procedure, followed by 60 IU/kg 12 hours after the first infusion, and up to 120 IU/kg 24 hours after the first infusion. Bolus infusions would continue every 12 hours for a minimum of 3 days; or~IB1001 Continuous Infusion Regimen: IB1001 infused at a target range of 70% to 110% for a minimum of 3 days post-procedure."
10942089|NCT00768287|EG000|Reported Event|IB1001 Safety Population|Adverse Events were only analyzed for the IB1001 safety population; they were not collected per intervention. The safety population is defined as all subjects who received at least one dose of IB1001 in any part of the study.
10942090|NCT00768300|BG000|Baseline|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
10942091|NCT00768300|BG001|Baseline|Placebo|Placebo to match ambrisentan administered orally once daily
10942092|NCT00768300|BG002|Baseline|Total|Total of all reporting groups
10942093|NCT00768300|FG000|Participant Flow|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
10942094|NCT00768300|FG001|Participant Flow|Placebo|Placebo to match ambrisentan administered orally once daily
11177248|NCT02039856|BG001|Baseline|Routine WH-PACT Implementation|VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities
10942095|NCT00768300|OG000|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
10942096|NCT00768300|OG001|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
10942097|NCT00768300|EG000|Reported Event|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
10942098|NCT00768300|EG001|Reported Event|Placebo|Placebo to match ambrisentan administered orally once daily
10942099|NCT00768430|BG000|Baseline|Ketamine|Ketamine
10942100|NCT00768430|BG001|Baseline|Midazolam|Midazolam
10942101|NCT00768430|BG002|Baseline|Total|Total of all reporting groups
10942102|NCT00768430|FG000|Participant Flow|Ketamine|single infusion of 0.5mg/kg of Ketamine HCL
10942103|NCT00768430|FG001|Participant Flow|Midazolam|single infusion of midazolam being used as an active control for the study
11177249|NCT02039856|BG002|Baseline|Total|Total of all reporting groups
11177250|NCT02039856|FG000|Participant Flow|EBQI-Supported WH-PACT Implementation|Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.
10942104|NCT00768430|OG000|Outcome|Ketamine|Ketamine
10942105|NCT00768430|OG001|Outcome|Midazolam|Midazolam
10942106|NCT00768430|EG000|Reported Event|Ketamine|Ketamine
10942107|NCT00768430|EG001|Reported Event|Midazolam|Midazolam
10942108|NCT00768469|BG000|Baseline|Nera 160 + Pac|Neratinib 160 mg + Paclitaxel 80 mg/m^2
10942109|NCT00768469|BG001|Baseline|Nera 240 + Pac|Neratinib 240 mg + Paclitaxel 80 mg/m^2
10942110|NCT00768469|BG002|Baseline|Total|Total of all reporting groups
10942111|NCT00768469|FG000|Participant Flow|Nera 160 + Pac|Neratinib 160 mg + Paclitaxel 80 mg/m^2
10942112|NCT00768469|FG001|Participant Flow|Nera 240 + Pac|Neratinib 240 mg + Paclitaxel 80 mg/m^2
10942113|NCT00768469|OG000|Outcome|Nera 160 + Pac|Neratinib 160 mg + Paclitaxel 80 mg/m^2
10942114|NCT00768469|OG001|Outcome|Nera 240 + Pac|Neratinib 240 mg + Paclitaxel 80 mg/m^2
10942115|NCT00768469|OG000|Outcome|Nera + Pac|Neratinib + Paclitaxel 80 mg/m^2
10942116|NCT00768469|EG000|Reported Event|Nera 160 + Pac|Neratinib 160 mg + Paclitaxel 80 mg/m^2
10942117|NCT00768469|EG001|Reported Event|Nera 240 + Pac|Neratinib 240 mg + Paclitaxel 80 mg/m^2
10942118|NCT00768521|BG000|Baseline|All Participants|All Study Participants from all groups.
10942119|NCT00768521|FG000|Participant Flow|Tolterodine Then Placebo|Tolterodine 4 mg then Placebo
10942120|NCT00768521|FG001|Participant Flow|Placebo Then Tolterodine|Placebo then Tolterodine 4 mg
10942121|NCT00768521|OG000|Outcome|Tolterodine|Tolterodine 4 mg
10942122|NCT00768521|OG001|Outcome|Placebo|
10942123|NCT00768521|EG000|Reported Event|Tolterodine|Tolterodine 4 mg
10942124|NCT00768521|EG001|Reported Event|Placebo|
10942125|NCT00768560|BG000|Baseline|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
10942126|NCT00768560|BG001|Baseline|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
10942127|NCT00768560|BG002|Baseline|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
10942128|NCT00768560|BG003|Baseline|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
10942129|NCT00768560|BG004|Baseline|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
10942130|NCT00768560|BG005|Baseline|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
10942131|NCT00768560|BG006|Baseline|Total|Total of all reporting groups
10942132|NCT00768560|FG000|Participant Flow|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
11177251|NCT02039856|FG001|Participant Flow|Routine WH-PACT Implementation|PACT implementation is a nationally mandated VA initiative for medical home implementation in VA primary care and women's health clinics, supported by VA Handbooks on PACT and Women's Health policy and practice guidance from national VA primary care and women's health program offices that are disseminated nationally to all VA facilities.
10942133|NCT00768560|FG001|Participant Flow|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
10942134|NCT00768560|FG002|Participant Flow|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
10942135|NCT00768560|FG003|Participant Flow|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
10942136|NCT00768560|FG004|Participant Flow|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
10942137|NCT00768560|FG005|Participant Flow|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
10942138|NCT00768560|OG000|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
10942139|NCT00768560|OG001|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
11177252|NCT02039856|OG000|Outcome|EBQI-Supported WH-PACT Implementation|Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.
10942140|NCT00768560|OG002|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
10942141|NCT00768560|EG000|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
10942142|NCT00768560|EG001|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
10942143|NCT00768560|EG002|Reported Event|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
10963455|NCT00872027|BG000|Baseline|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
10963456|NCT00872027|BG001|Baseline|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
10963457|NCT00872027|BG002|Baseline|Total|Total of all reporting groups
10963458|NCT00872027|FG000|Participant Flow|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
10963459|NCT00872027|FG001|Participant Flow|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
10963460|NCT00872027|OG000|Outcome|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
10963461|NCT00872027|OG001|Outcome|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
10963462|NCT00872027|EG000|Reported Event|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
10963463|NCT00872027|EG001|Reported Event|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
10963464|NCT00872079|BG000|Baseline|Genomics|"The specific aims of this research are:~Determine the structure and the type of neural network model for predictions from historically obtained data. (Computer Model)~Prospectively develop an individualized neural network and NONMEM model capable of predicting erythropoietin dosing for chronic in-center hemodialysis patients using adaptive techniques.~Develop computer programs based on neural computing that can be used in a clinical setting. (Computer Model)~Determine the utility of the computer programs prospectively in the clinical setting."
10963465|NCT00872079|FG000|Participant Flow|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
10963466|NCT00872079|OG000|Outcome|Genomics|"Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.~There are 4 Aims in this study.~To collect historical data on warfarin dosing in subjects.~To collect genotype information on up to 300 subjects receiving warfarin anticoagulation.~to develop a computer model incorporating the information from aim 1 and aim 2.~To conduct a randomized clinical trial."
10963467|NCT00872079|EG000|Reported Event|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
11177253|NCT02039856|OG001|Outcome|Routine WH-PACT Implementation|VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities.
11341663|NCT03686033|EG003|Reported Event|Open-label Treatment: E2082 40 mg|Participants received, E2082 40 mg tablet, orally, once on Day 1 of Treatment Period 4 in all the sequences.
10942144|NCT00768599|BG000|Baseline|Reference Drug|Econazole Nitrate Cream 1%
10942145|NCT00768599|BG001|Baseline|Test Drug|Econazole Nitrate Foam 1%
10942146|NCT00768599|BG002|Baseline|Control|Vehicle Foam
10942147|NCT00768599|BG003|Baseline|Total|Total of all reporting groups
10942148|NCT00768599|FG000|Participant Flow|Reference Drug|Econazole Nitrate Cream 1%
10942149|NCT00768599|FG001|Participant Flow|Test Drug|Econazole Nitrate Foam 1%
10942150|NCT00768599|FG002|Participant Flow|Control|Vehicle Foam
10942151|NCT00768599|OG000|Outcome|Reference Drug|Econazole Nitrate Cream 1%
10942152|NCT00768599|OG001|Outcome|Test Drug|Econazole Nitrate Foam 1%
10942153|NCT00768599|OG002|Outcome|Control|Vehicle Foam
10942154|NCT00768599|EG000|Reported Event|Reference Drug|Econazole Nitrate Cream 1%
10942155|NCT00768599|EG001|Reported Event|Test Drug|Econazole Nitrate Foam 1%
10942156|NCT00768599|EG002|Reported Event|Control|Vehicle Foam
10942157|NCT00768651|BG000|Baseline|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
10942158|NCT00768651|FG000|Participant Flow|Sitagliptin + Pantoprazole|"Intervention Details:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months, followed by a three-month washout.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months, followed by a three-month washout."
10942159|NCT00768651|OG000|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
10942160|NCT00768651|OG000|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
10942161|NCT00768651|EG000|Reported Event|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
10942162|NCT00768664|BG000|Baseline|Dacomitinib 45 mg|Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.
10942163|NCT00768664|FG000|Participant Flow|Dacomitinib 45 mg|Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.
10942164|NCT00768664|OG000|Outcome|Dacomitinib 45 mg|Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.
10942165|NCT00768664|EG000|Reported Event|Dacomitinib 45 mg|Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.
10942166|NCT00768716|BG000|Baseline|White Subjects|2 x 500 mg acetaminophen by mouth once
10942167|NCT00768716|BG001|Baseline|Black Subjects|2 x 500 mg acetaminophen by mouth once
10942168|NCT00768716|BG002|Baseline|Total|Total of all reporting groups
10942169|NCT00768716|FG000|Participant Flow|White Subjects|"2 x 500 mg acetaminophen by mouth once~Acetaminophen: 2 x 500 mg by mouth once"
11341664|NCT03686176|BG000|Baseline|Virtual Reality Group (Study Group)|"In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure.~Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins."
10942170|NCT00768716|FG001|Participant Flow|Black Subjects|"2 x 500 mg acetaminophen by mouth once~Acetaminophen: 2 x 500 mg by mouth once"
10942171|NCT00768716|OG000|Outcome|White Subjects|2 x 500 mg acetaminophen by mouth once
10942172|NCT00768716|OG001|Outcome|Black Subjects|2 x 500 mg acetaminophen by mouth once
10942173|NCT00768716|OG000|Outcome|UGT2B15*1/*1|UGT2B15 genotype
10942174|NCT00768716|OG001|Outcome|UGT2B15*1/*2|UGT2B15 genotype
10942175|NCT00768716|OG002|Outcome|UGT2B15*2/*2|UGT2B15 genotype
10942176|NCT00768716|EG000|Reported Event|White Subjects|2 x 500 mg acetaminophen by mouth once
10942177|NCT00768716|EG001|Reported Event|Black Subjects|2 x 500 mg acetaminophen by mouth once
10942178|NCT00768755|BG000|Baseline|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
10942179|NCT00768755|BG001|Baseline|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942180|NCT00768755|BG002|Baseline|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942181|NCT00768755|BG003|Baseline|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942182|NCT00768755|BG004|Baseline|Total|Total of all reporting groups
10942183|NCT00768755|FG000|Participant Flow|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
10942184|NCT00768755|FG001|Participant Flow|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942185|NCT00768755|FG002|Participant Flow|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942186|NCT00768755|FG003|Participant Flow|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942187|NCT00768755|OG000|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942188|NCT00768755|OG001|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942189|NCT00768755|OG002|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942190|NCT00768755|EG000|Reported Event|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
10942191|NCT00768755|EG001|Reported Event|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10963468|NCT00872170|BG000|Baseline|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
10942192|NCT00768755|EG002|Reported Event|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942193|NCT00768755|EG003|Reported Event|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
10942194|NCT00768898|BG000|Baseline|Overall|All enrolled participants
10942195|NCT00768898|FG000|Participant Flow|Overall|All enrolled participants
10942196|NCT00768898|OG000|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green were instilled in each eye.
10942197|NCT00768898|OG001|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
10942198|NCT00768898|OG002|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
10942199|NCT00768898|OG000|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
10942200|NCT00768898|EG000|Reported Event|2.5 Microliters Lissamine Green|2.5 microliters lissamine green
10942201|NCT00768898|EG001|Reported Event|5.0 Microliters Lissamine Green|5.0 microliters lissamine green
10942202|NCT00768898|EG002|Reported Event|10.0 Microliters Lissamine Green|10.0 microliters lissamine green
10942203|NCT00768989|BG000|Baseline|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
10942204|NCT00768989|BG001|Baseline|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
10942205|NCT00768989|BG002|Baseline|Total|Total of all reporting groups
10942206|NCT00768989|FG000|Participant Flow|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
10942207|NCT00768989|FG001|Participant Flow|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
10942208|NCT00768989|OG000|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
10942209|NCT00768989|OG001|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
10942210|NCT00768989|OG000|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
10942211|NCT00768989|OG000|Outcome|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
10942212|NCT00768989|EG000|Reported Event|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/Emtricitabine, 300 mg/200 mg once daily
10942213|NCT00768989|EG001|Reported Event|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
10942214|NCT00769015|BG000|Baseline|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
11192169|NCT02137512|BG000|Baseline|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs - a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
11341665|NCT03686176|BG001|Baseline|Standard Care (Control Group)|In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.
10942215|NCT00769015|BG001|Baseline|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
10942216|NCT00769015|BG002|Baseline|Total|Total of all reporting groups
10942217|NCT00769015|FG000|Participant Flow|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
10942218|NCT00769015|FG001|Participant Flow|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
10942219|NCT00769015|OG000|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
10942220|NCT00769015|OG001|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
10942221|NCT00769015|EG000|Reported Event|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
10942222|NCT00769015|EG001|Reported Event|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
10942223|NCT00769067|BG000|Baseline|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942224|NCT00769067|BG001|Baseline|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942225|NCT00769067|BG002|Baseline|Total|Total of all reporting groups
10942226|NCT00769067|FG000|Participant Flow|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942227|NCT00769067|FG001|Participant Flow|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942228|NCT00769067|OG000|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942229|NCT00769067|OG001|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942230|NCT00769067|OG000|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942231|NCT00769067|EG000|Reported Event|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942232|NCT00769067|EG001|Reported Event|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
10942233|NCT00769119|BG000|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
10942234|NCT00769119|BG001|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
10942235|NCT00769119|BG002|Baseline|Total|Total of all reporting groups
10942236|NCT00769119|FG000|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
10942237|NCT00769119|FG001|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
10942238|NCT00769119|OG000|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
11177254|NCT02039856|OG000|Outcome|EBQI-Supported WH-PACT Implementation|"Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.~Multilevel stakeholder engagement: Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings.~Quality improvement (QI) education/training: Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement~Technical support: Research team provided technical review of and feedback"
10942239|NCT00769119|OG001|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
10942240|NCT00769119|EG000|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
10942241|NCT00769119|EG001|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
10942242|NCT00769132|BG000|Baseline|Totals for Study|All participants in the study.
10942243|NCT00769132|FG000|Participant Flow|Sequence 1: D/C/A/B|"A = Extended Release (ER) niacin 2 g/laropiprant 40 mg once daily for 7 days~B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
10942244|NCT00769132|FG001|Participant Flow|Sequence 2: C/B/D/A|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
10942245|NCT00769132|FG002|Participant Flow|Sequence 3: B/A/C/D|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
10942246|NCT00769132|FG003|Participant Flow|Sequence 4: A/D/B/C|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days~B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
10942247|NCT00769132|OG000|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
10942248|NCT00769132|OG001|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
10942249|NCT00769132|OG002|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
10942250|NCT00769132|OG003|Outcome|Placebo|Placebo daily for 7 days
10942251|NCT00769132|EG000|Reported Event|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg once daily for 7 days
10942252|NCT00769132|EG001|Reported Event|ER Niacin 2 g|ER niacin 2 g once daily for 7 days
10942253|NCT00769132|EG002|Reported Event|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
10942254|NCT00769132|EG003|Reported Event|Placebo|Placebo once daily for 7 days
10942255|NCT00769184|BG000|Baseline|Corticosteroid+LCD vs Corticosteroid+Placebo|"one side of body: corticosteroid and liquor carbonis distillate (LCD) treatment applied twice a day, for 2 weeks, then LCD-only twice a day, for 4 weeks, then no treatment for 6 weeks~opposite side of body: corticosteroid and placebo vehicle solution twice a day, for 2 weeks, then placebo vehicle solution-only twice a day, for 4 weeks, then no treatment for 6 weeks"
10942256|NCT00769184|FG000|Participant Flow|Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)|"Corticosteroid + LCD on left side of body, Corticosteroid + Placebo on right side of body (n=7).~On left side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks~On right side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
10942257|NCT00769184|FG001|Participant Flow|Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)|"Corticosteroid + LCD on right side of body, Corticosteroid + Placebo on left side of body (n=8).~On right side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks~On left side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
10942258|NCT00769184|OG000|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
10942259|NCT00769184|OG001|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
10942260|NCT00769184|OG000|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution-only applied to one side of the body twice per day for 4 weeks.
10942261|NCT00769184|OG001|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo solution applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
10942262|NCT00769184|EG000|Reported Event|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
10942263|NCT00769184|EG001|Reported Event|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
10942264|NCT00769314|BG000|Baseline|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet/Intent-to-Treat population
10942265|NCT00769314|BG001|Baseline|Placebo Group|muco-adhesive buccal tablet with placebo/Intent-to-Treat population
10942266|NCT00769314|BG002|Baseline|Total|Total of all reporting groups
10942267|NCT00769314|FG000|Participant Flow|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
10942268|NCT00769314|FG001|Participant Flow|Placebo Group|muco-adhesive buccal tablet with placebo
10942269|NCT00769314|OG000|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
10942270|NCT00769314|OG001|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
10942271|NCT00769314|EG000|Reported Event|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
10942272|NCT00769314|EG001|Reported Event|Placebo Group|muco-adhesive buccal tablet with placebo
10942273|NCT00769392|BG000|Baseline|All Participants|Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
10942274|NCT00769392|FG000|Participant Flow|All Study Participants|All participants received, in an randomized cross-over fashion, Proparacaine drops, Tetracaine drops, Lidocaine 4% soaked cotton sponge, and Lidocaine 2% subconjunctival injection.
10942275|NCT00769392|OG000|Outcome|All Participants|Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
10942276|NCT00769392|EG000|Reported Event|All Participants|Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
10942277|NCT00769483|BG000|Baseline|Arm A / Phase I|Arm A: MK-0646 (MK) + gemcitabine(G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. .
10942278|NCT00769483|BG001|Baseline|Arm B / Phase I|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
10942279|NCT00769483|BG002|Baseline|Arm A / Phase II Randomization|Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
10942280|NCT00769483|BG003|Baseline|Arm B / Phase II Randomization|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
10942281|NCT00769483|BG004|Baseline|Arm C / Phase II Randomization|Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
10942282|NCT00769483|BG005|Baseline|Phase II Expansion|MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
10942283|NCT00769483|BG006|Baseline|Total|Total of all reporting groups
10942284|NCT00769483|FG000|Participant Flow|Arm A / Phase I|Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
10942285|NCT00769483|FG001|Participant Flow|Arm B / Phase I|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
10942286|NCT00769483|FG002|Participant Flow|Arm A / Phase II Randomization|Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
10942287|NCT00769483|FG003|Participant Flow|Arm B / Phase II Randomization|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
10942288|NCT00769483|FG004|Participant Flow|Arm C / Phase II Randomization|Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
10942289|NCT00769483|FG005|Participant Flow|Phase II Expansion|MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
11341666|NCT03686176|BG002|Baseline|Reference Group|No virtual reality and no child life specialists; no standardized or formal form of support.
10942290|NCT00769483|OG000|Outcome|Arm A / Phase I|Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
10942291|NCT00769483|OG001|Outcome|Arm B / Phase I|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
10942292|NCT00769483|OG002|Outcome|Arm A / Phase II Randomization|Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
10942293|NCT00769483|OG003|Outcome|Arm B / Phase II Randomization|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
10942294|NCT00769483|OG004|Outcome|Arm C / Phase II Randomization|Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
10942295|NCT00769483|OG005|Outcome|Phase II Expansion|MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
10942296|NCT00769483|OG003|Outcome|Arm B / Phase II Randomization|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E)G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
10942297|NCT00769483|OG001|Outcome|Arm B / Phase I|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E)G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
10942298|NCT00769483|EG000|Reported Event|Arm A / Phase I|Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
10942299|NCT00769483|EG001|Reported Event|Arm B / Phase I|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
10942300|NCT00769483|EG002|Reported Event|Arm A / Phase II Randomization|Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
10942301|NCT00769483|EG003|Reported Event|Arm B / Phase II Randomization|Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
10942302|NCT00769483|EG004|Reported Event|Arm C / Phase II Randomization|Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
10942303|NCT00769483|EG005|Reported Event|Phase II Expansion|MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
10942304|NCT00769561|BG000|Baseline|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
10942305|NCT00769561|BG001|Baseline|Occlusal Splint|Dental treatment with occlusal splint
10942306|NCT00769561|BG002|Baseline|Total|Total of all reporting groups
10942307|NCT00769561|FG000|Participant Flow|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
10942308|NCT00769561|FG001|Participant Flow|Occlusal Splint|Dental treatment with occlusal splint
10942309|NCT00769561|OG000|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
10942310|NCT00769561|OG001|Outcome|Occlusal Splint|Dental treatment with occlusal splint
10942311|NCT00769561|EG000|Reported Event|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
10942312|NCT00769561|EG001|Reported Event|Occlusal Splint|Dental treatment with occlusal splint
10963469|NCT00872170|BG001|Baseline|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
10963470|NCT00872170|BG002|Baseline|Total|Total of all reporting groups
10942313|NCT00769600|BG000|Baseline|Itraconazole Open Label Added to Standard of Care Pemetrexed|"Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).~Itraconazole: Itraconazole 200 mg once daily"
10942314|NCT00769600|BG001|Baseline|Single Agent Pemetrexed|"Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.~Pemetrexed"
10942315|NCT00769600|BG002|Baseline|Total|Total of all reporting groups
10942316|NCT00769600|FG000|Participant Flow|Itraconazole Open Label Added to Standard of Care Pemetrexed|"Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).~Itraconazole: Itraconazole 200 mg once daily"
10942317|NCT00769600|FG001|Participant Flow|Single Agent Pemetrexed|"Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.~Pemetrexed"
10942318|NCT00769600|OG000|Outcome|Arm A|Itraconazole plus pemetrexed
10942319|NCT00769600|OG001|Outcome|Arm B|Pemetrexed alone
10942320|NCT00769600|OG000|Outcome|Itraconazole Open Label Added to Standard of Care Pemetrexed|"Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).~Itraconazole: Itraconazole 200 mg once daily"
10942321|NCT00769600|OG001|Outcome|Single Agent Pemetrexed|Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.
10942322|NCT00769600|OG001|Outcome|Single Agent Pemetrexed|"Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.~Pemetrexed"
10942323|NCT00769600|EG000|Reported Event|Itraconazole Open Label Added to Standard of Care Pemetrexed|"Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).~Itraconazole: Itraconazole 200 mg once daily"
11177255|NCT02039856|OG001|Outcome|Routine WH-PACT Implementation|"National policy guidance~National policy guidance: VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities"
11177256|NCT02039856|EG000|Reported Event|EBQI-Supported WH-PACT Implementation|Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.
11177257|NCT02039856|EG001|Reported Event|Routine WH-PACT Implementation|National policy guidance including VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities.
11177258|NCT02039908|BG000|Baseline|Phase 1-Summer|In the first phase of the study, all children participate in a crossover design of placebo and optimal-dose methylphenidate for 13 days in each condition.
11341667|NCT03686176|BG003|Baseline|Total|Total of all reporting groups
10942324|NCT00769600|EG001|Reported Event|Single Agent Pemetrexed|"Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.~Pemetrexed"
10942325|NCT00769704|BG000|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
10942326|NCT00769704|BG001|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
10942327|NCT00769704|BG002|Baseline|Total|Total of all reporting groups
10942328|NCT00769704|FG000|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
10942329|NCT00769704|FG001|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
10942330|NCT00769704|OG000|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
10942331|NCT00769704|OG001|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
10942332|NCT00769704|OG001|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
10942333|NCT00769704|EG000|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
10942334|NCT00769704|EG001|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
10942335|NCT00769808|BG000|Baseline|Technolas 217z Excimer Laser|"Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism.~Bausch & Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism"
10942336|NCT00769808|FG000|Participant Flow|Technolas 217z Excimer Laser|"Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism.~Bausch & Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism"
10942337|NCT00769808|OG000|Outcome|Technolas 217z Excimer Laser|"Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism.~Bausch & Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism"
10942338|NCT00769808|EG000|Reported Event|Technolas 217z Excimer Laser|"Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism.~Bausch & Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism"
10942339|NCT00769860|BG000|Baseline|Arimoclomol|Arimoclomol 100 mg TID for 4 months
10942340|NCT00769860|BG001|Baseline|Placebo|Matched placebo pills, 100 mg TID for 4 months
10942341|NCT00769860|BG002|Baseline|Total|Total of all reporting groups
10942342|NCT00769860|FG000|Participant Flow|Arimoclomol|Arimoclomol 100 mg TID for 4 months
10942343|NCT00769860|FG001|Participant Flow|Placebo|Matched placebo pills, 100 mg TID for 4 months
10942344|NCT00769860|OG000|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
10942345|NCT00769860|OG001|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
10942346|NCT00769860|EG000|Reported Event|Arimoclomol|Arimoclomol 100 mg TID for 4 months
10942347|NCT00769860|EG001|Reported Event|Placebo|Matched placebo pills, 100 mg TID for 4 months
10942348|NCT00769886|BG000|Baseline|KetoNaph|KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
10942349|NCT00769886|BG001|Baseline|Ketotifen|Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
11177259|NCT02039908|FG000|Participant Flow|Phase 1-Summer; Medication First, Then Placebo|In the first phase of the study, children participated in a crossover design of placebo and optimal-dose methylphenidate for 13 days in each condition. After a 9-day titration period, the Medication First group received their optimal dose of methylphenidate for 13 days, a 2-day medication/placebo probe, a 2-day washout, then placebo for 13 days and a 2-day medication/placebo probe.
11177260|NCT02039908|FG001|Participant Flow|Phase 1-Summer; Placebo First, Then Medication|In the first phase of the study, children participated in a crossover design of placebo and optimal-dose methylphenidate for 13 days in each condition. After a 9-day titration period, the Placebo First group received placebo for 13 days, a 2-day medication/placebo probe, a 2-day washout, then optimal-dose medication for 13 days and a 2-day medication/placebo probe.
10942350|NCT00769886|BG002|Baseline|Naphazoline|Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
10942351|NCT00769886|BG003|Baseline|Vehicle|Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
10942352|NCT00769886|BG004|Baseline|Total|Total of all reporting groups
10942353|NCT00769886|FG000|Participant Flow|KetoNaph|"KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution~Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4."
10942354|NCT00769886|FG001|Participant Flow|Ketotifen|"Ketotifen fumarate 0.025% ophthalmic solution~Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4."
10942355|NCT00769886|FG002|Participant Flow|Naphazoline|"Naphazoline HCl 0.05% ophthalmic solution~Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4."
10942356|NCT00769886|FG003|Participant Flow|Vehicle|"Vehicle of KetoNaph ophthalmic solution~Vehicle: One drop of vehicle in study eye at visit 3 and visit 4."
10942357|NCT00769886|OG000|Outcome|KetoNaph|"KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution~Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4."
10942358|NCT00769886|OG001|Outcome|Ketotifen|"Ketotifen fumarate 0.025% ophthalmic solution~Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4."
10942359|NCT00769886|OG002|Outcome|Naphazoline|"Naphazoline HCl 0.05% ophthalmic solution~Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4."
10942360|NCT00769886|OG003|Outcome|Vehicle|"Vehicle of KetoNaph ophthalmic solution~Vehicle: One drop of vehicle in study eye at visit 3 and visit 4."
10942361|NCT00769886|EG000|Reported Event|KetoNaph|"KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution~Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4."
10942362|NCT00769886|EG001|Reported Event|Ketotifen|"Ketotifen fumarate 0.025% ophthalmic solution~Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4."
10942363|NCT00769886|EG002|Reported Event|Naphazoline|"Naphazoline HCl 0.05% ophthalmic solution~Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4."
10942364|NCT00769886|EG003|Reported Event|Vehicle|"Vehicle of KetoNaph ophthalmic solution~Vehicle: One drop of vehicle in study eye at visit 3 and visit 4."
10942365|NCT00770029|BG000|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
10942366|NCT00770029|BG001|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
10942367|NCT00770029|BG002|Baseline|Total|Total of all reporting groups
10942368|NCT00770029|FG000|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
10942369|NCT00770029|FG001|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
10942370|NCT00770029|OG000|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
10942371|NCT00770029|OG001|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
10942372|NCT00770029|EG000|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
10942373|NCT00770029|EG001|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
10942374|NCT00770120|BG000|Baseline|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
10942375|NCT00770120|FG000|Participant Flow|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
10942376|NCT00770120|OG000|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
10942377|NCT00770120|OG000|Outcome|Everolimus|Daily oral Everolimus 10 mg/day
10942378|NCT00770120|EG000|Reported Event|Everolimus|Daily oral Everolimus 10 mg/day
10942379|NCT00770133|BG000|Baseline|Ketotifen/Naphazoline|"Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4."
10942380|NCT00770133|BG001|Baseline|Ketotifen|"Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4."
10942381|NCT00770133|BG002|Baseline|Naphazoline|"Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4."
10942382|NCT00770133|BG003|Baseline|Vehicle|"Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4."
10942383|NCT00770133|BG004|Baseline|Total|Total of all reporting groups
10942384|NCT00770133|FG000|Participant Flow|Ketotifen/Naphazoline|"Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4."
10942385|NCT00770133|FG001|Participant Flow|Ketotifen|"Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4."
10942386|NCT00770133|FG002|Participant Flow|Naphazoline|"Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4."
10942387|NCT00770133|FG003|Participant Flow|Vehicle|"Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4."
10942388|NCT00770133|OG000|Outcome|Ketotifen/Naphazoline|"Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4."
10942389|NCT00770133|OG001|Outcome|Ketotifen|"Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4."
10942390|NCT00770133|OG002|Outcome|Naphazoline|"Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4."
10942391|NCT00770133|OG003|Outcome|Vehicle|"Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4."
10942392|NCT00770133|EG000|Reported Event|Ketotifen/Naphazoline|"Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4."
10942393|NCT00770133|EG001|Reported Event|Ketotifen|"Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4."
10942394|NCT00770133|EG002|Reported Event|Naphazoline|"Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4."
10942395|NCT00770133|EG003|Reported Event|Vehicle|"Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.~Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4."
10942396|NCT00770146|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
10942397|NCT00770146|BG001|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10942398|NCT00770146|BG002|Baseline|Total|Total of all reporting groups
10942399|NCT00770146|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
10942400|NCT00770146|FG001|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10942401|NCT00770146|OG000|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
10942402|NCT00770146|OG001|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10942403|NCT00770146|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
10942404|NCT00770146|EG001|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
10942405|NCT00770211|BG000|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
10942406|NCT00770211|BG001|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
10942407|NCT00770211|BG002|Baseline|Total|Total of all reporting groups
10942408|NCT00770211|FG000|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
10942409|NCT00770211|FG001|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
10942410|NCT00770211|OG000|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
10942411|NCT00770211|OG001|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
10942412|NCT00770211|EG000|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
10942413|NCT00770211|EG001|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
10942414|NCT00770224|BG000|Baseline|R-CHOP+I-131 Tositumomab|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles~Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody."
10942415|NCT00770224|FG000|Participant Flow|R-CHOP+I-131 Tositumomab|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles~Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody."
10942416|NCT00770224|FG001|Participant Flow|Rituximab Maintenance|Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
10942417|NCT00770224|OG000|Outcome|R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles~Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody.~Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration."
10942418|NCT00770224|OG000|Outcome|R-CHOP+I-131 Tositumomab|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles~Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody."
10942419|NCT00770224|OG001|Outcome|Rituximab Maintenance|Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
10942420|NCT00770224|EG000|Reported Event|R-CHOP+I-131 Tositumomab|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles~Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody."
10942421|NCT00770224|EG001|Reported Event|Rituximab Maintenance|Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.
10942422|NCT00770289|BG000|Baseline|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
10942423|NCT00770289|FG000|Participant Flow|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
10942424|NCT00770289|OG000|Outcome|Hamilton Depression Scale (HAM-D)|Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
10942425|NCT00770289|OG000|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
10942426|NCT00770289|OG000|Outcome|Hamilton Depression Scale (HAM-D17)|Participants who were administered HAM-D17.
10942427|NCT00770289|OG001|Outcome|Hamilton Depression Scale (HAM-D7)|Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
10942428|NCT00770289|OG002|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
10942429|NCT00770289|OG000|Outcome|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion and did not display remission.
10942430|NCT00770289|EG000|Reported Event|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
10942431|NCT00770315|BG000|Baseline|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942432|NCT00770315|BG001|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942433|NCT00770315|BG002|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942434|NCT00770315|BG003|Baseline|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942435|NCT00770315|BG004|Baseline|Total|Total of all reporting groups
10942436|NCT00770315|FG000|Participant Flow|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942437|NCT00770315|FG001|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942438|NCT00770315|FG002|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942439|NCT00770315|FG003|Participant Flow|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942440|NCT00770315|OG000|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942441|NCT00770315|OG001|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942442|NCT00770315|OG002|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942443|NCT00770315|OG003|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942444|NCT00770315|EG000|Reported Event|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942445|NCT00770315|EG001|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942446|NCT00770315|EG002|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942447|NCT00770315|EG003|Reported Event|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
10942448|NCT00770328|BG000|Baseline|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
10942449|NCT00770328|BG001|Baseline|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
10942450|NCT00770328|BG002|Baseline|Total|Total of all reporting groups
10942451|NCT00770328|FG000|Participant Flow|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
10942452|NCT00770328|FG001|Participant Flow|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
10942453|NCT00770328|OG000|Outcome|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
10942454|NCT00770328|OG001|Outcome|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
10942455|NCT00770328|EG000|Reported Event|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
10942456|NCT00770328|EG001|Reported Event|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
10942457|NCT00770341|BG000|Baseline|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
10942458|NCT00770341|BG001|Baseline|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
10942459|NCT00770341|BG002|Baseline|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
10942460|NCT00770341|BG003|Baseline|Total|Total of all reporting groups
10942461|NCT00770341|FG000|Participant Flow|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
10942462|NCT00770341|FG001|Participant Flow|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
10942463|NCT00770341|FG002|Participant Flow|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
10942464|NCT00770341|OG000|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
10942465|NCT00770341|OG001|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
10942466|NCT00770341|OG002|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
10942467|NCT00770341|EG000|Reported Event|NOT TREATED|
10942468|NCT00770341|EG001|Reported Event|DAPTOMYCIN (4 MG/KG)|
10942469|NCT00770341|EG002|Reported Event|VANCOMYCIN|
10942470|NCT00770341|EG003|Reported Event|DAPTOMYCIN (6 MG/KG)|
10942471|NCT00770367|BG000|Baseline|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
10942472|NCT00770367|BG001|Baseline|Placebo|The analysis period during which participant took the placebo.
10942473|NCT00770367|BG002|Baseline|Total|Total of all reporting groups
10942474|NCT00770367|FG000|Participant Flow|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
10942475|NCT00770367|FG001|Participant Flow|Placebo|The analysis period during which participant took the placebo.
10942476|NCT00770367|OG000|Outcome|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
10942477|NCT00770367|OG001|Outcome|Placebo|The analysis period during which participant took the placebo.
10942478|NCT00770367|OG000|Outcome|Pioglitazone Then Placebo|"18 volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take Pioglitazone for the first 12 week period of the study and then take the placebo for the final 12 weeks of the study.~Pioglitazone then Placebo: Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo."
10942479|NCT00770367|OG001|Outcome|Placebo Then Pioglitazone|"18 (other half of participants) volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take the placebo for the first 12 week period of the study and then take the Pioglitazone for the final 12 weeks of the study.~Placebo then Pioglitazone: Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months."
10942480|NCT00770367|EG000|Reported Event|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
10942481|NCT00770367|EG001|Reported Event|Placebo|The analysis period during which participant took the placebo.
10942482|NCT00770432|BG000|Baseline|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
10942483|NCT00770432|BG001|Baseline|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
10942484|NCT00770432|BG002|Baseline|Total|Total of all reporting groups
10942485|NCT00770432|FG000|Participant Flow|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
10942486|NCT00770432|FG001|Participant Flow|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
10942487|NCT00770432|OG000|Outcome|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
10942488|NCT00770432|OG001|Outcome|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
10942489|NCT00770432|EG000|Reported Event|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
10942490|NCT00770432|EG001|Reported Event|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
10942491|NCT00770484|BG000|Baseline|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
10942492|NCT00770484|BG001|Baseline|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
10942493|NCT00770484|BG002|Baseline|Total|Total of all reporting groups
10942494|NCT00770484|FG000|Participant Flow|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
10942495|NCT00770484|FG001|Participant Flow|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
10942496|NCT00770484|OG000|Outcome|Propranolol|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
10942497|NCT00770484|OG001|Outcome|Placebo|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
10942498|NCT00770484|EG000|Reported Event|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
10942499|NCT00770484|EG001|Reported Event|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
10942500|NCT00770510|BG000|Baseline|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.~Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)~A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
10942501|NCT00770510|FG000|Participant Flow|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.~Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)~A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
10942502|NCT00770510|OG000|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942503|NCT00770510|OG001|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942504|NCT00770510|OG002|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942505|NCT00770510|OG003|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942506|NCT00770510|OG004|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942507|NCT00770510|EG000|Reported Event|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942508|NCT00770510|EG001|Reported Event|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942509|NCT00770510|EG002|Reported Event|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942510|NCT00770510|EG003|Reported Event|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942511|NCT00770510|EG004|Reported Event|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
10942512|NCT00770562|BG000|Baseline|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
10942513|NCT00770562|BG001|Baseline|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
10942514|NCT00770562|BG002|Baseline|Total|Total of all reporting groups
10963471|NCT00872170|FG000|Participant Flow|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
10963472|NCT00872170|FG001|Participant Flow|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
10942515|NCT00770562|FG000|Participant Flow|Arm A: Dexamethasone|Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
10942516|NCT00770562|FG001|Participant Flow|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
10942517|NCT00770562|OG000|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
10942518|NCT00770562|OG001|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
10942519|NCT00770562|EG000|Reported Event|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4).
10942520|NCT00770562|EG001|Reported Event|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
10942521|NCT00770562|EG002|Reported Event|Salvage Therapy|Nonresponsive (failed to achieve a sustained response) participants from Arm A (dexamethasone monotherapy) who had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants from Arm B (dexamethasone + rituximab) with platelets <20 x10^9/L or with active bleeding were treated with salvage therapy of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
10942522|NCT00770588|BG000|Baseline|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
10942523|NCT00770588|BG001|Baseline|Placebo|placebo 1 tablet daily
10942524|NCT00770588|BG002|Baseline|Total|Total of all reporting groups
10942525|NCT00770588|FG000|Participant Flow|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
10942526|NCT00770588|FG001|Participant Flow|Placebo|placebo 1 tablet daily
10942527|NCT00770588|OG000|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
10942528|NCT00770588|OG001|Outcome|Placebo|placebo 1 tablet daily
10942529|NCT00770588|OG001|Outcome|Placebo|Placebo 1 tablet daily
10942530|NCT00770588|EG000|Reported Event|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
10942531|NCT00770588|EG001|Reported Event|Placebo|placebo 1 tablet daily
10942532|NCT00770601|BG000|Baseline|Canakinumab (ACZ885)|Participants received body-weight stratified dosage of canakinumab treatment at 300 mg (for participants weighing more than 40 kg) and at 2 mg/kg (for participants weight less than or equal to 40 kg) subcutaneously every 4-8 weeks as per investigator discretion for a treatment period of 6 months. The first 3 NOMID participants enrolled received a dose of 150 mg (>40 kg) and 2 mg/kg for children <40 kg. Since this dose was insufficient to fully control the symptoms of the disease the 300 mg / 4mg/kg dose was introduced by Protocol Amendment 2.
10942533|NCT00770601|FG000|Participant Flow|Canakinumab (ACZ885)|Participants received body-weight stratified dosage of canakinumab treatment at 300 milligrams (mg) (for participants weighing more than 40 kilograms (kg)) and at 2 mg/kg (for participants weight less than or equal to 40 kg) subcutaneously every 4-8 weeks as per investigator discretion for a treatment period of 6 months. The first 3 Neonatal-Onset Multisystem Inflammatory Disease (NOMID) participants enrolled received a dose of 150 mg (>40 kg) and 2 mg/kg for children <40 kg. Since this dose was insufficient to fully control the symptoms of the disease the 300 mg / 4mg/kg dose was introduced by Protocol Amendment 2.
10942534|NCT00770601|OG000|Outcome|Canakinumab (ACZ885)|Participants received body-weight stratified dosage of canakinumab treatment at 300 mg (for participants weighing more than 40 kg) and at 2 mg/kg (for participants weight less than or equal to 40 kg) subcutaneously every 4-8 weeks as per investigator discretion for a treatment period of 6 months. The first 3 NOMID participants enrolled received a dose of 150 mg (>40 kg) and 2 mg/kg for children <40 kg. Since this dose was insufficient to fully control the symptoms of the disease the 300 mg / 4mg/kg dose was introduced by Protocol Amendment 2.
10963473|NCT00872170|OG000|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
10942535|NCT00770601|EG000|Reported Event|Canakinumab (ACZ885)|Participants received body-weight stratified dosage of canakinumab treatment at 300 mg (for participants weighing more than 40 kg) and at 2 mg/kg (for participants weight less than or equal to 40 kg) subcutaneously every 4-8 weeks as per investigator discretion for a treatment period of 6 months. The first 3 NOMID participants enrolled received a dose of 150 mg (>40 kg) and 2 mg/kg for children <40 kg. Since this dose was insufficient to fully control the symptoms of the disease the 300 mg / 4mg/kg dose was introduced by Protocol Amendment 2.
10942536|NCT00770653|BG000|Baseline|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
10942537|NCT00770653|BG001|Baseline|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
10942538|NCT00770653|BG002|Baseline|Total|Total of all reporting groups
10942539|NCT00770653|FG000|Participant Flow|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
10942540|NCT00770653|FG001|Participant Flow|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
10942541|NCT00770653|OG000|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
10942542|NCT00770653|OG001|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
10942543|NCT00770653|EG000|Reported Event|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
10942544|NCT00770653|EG001|Reported Event|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
10942545|NCT00770679|BG000|Baseline|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
10942546|NCT00770679|FG000|Participant Flow|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
10942547|NCT00770679|OG000|Outcome|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
10942548|NCT00770679|EG000|Reported Event|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
10942549|NCT00770692|BG000|Baseline|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
10942550|NCT00770692|BG001|Baseline|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
10942551|NCT00770692|BG002|Baseline|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
10942552|NCT00770692|BG003|Baseline|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
10942553|NCT00770692|BG004|Baseline|Total|Total of all reporting groups
10942554|NCT00770692|FG000|Participant Flow|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
10942555|NCT00770692|FG001|Participant Flow|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
10942556|NCT00770692|FG002|Participant Flow|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
10942557|NCT00770692|FG003|Participant Flow|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
10942558|NCT00770692|OG000|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
11177261|NCT02039908|FG002|Participant Flow|Phase 2 School Year - 7-Day Dosing|During the school year, all participants took their optimal dose determined in Phase 1 of the study for the entire school year. These partcipants received medication 7-days a week for the entire year.
11177262|NCT02039908|FG003|Participant Flow|Phase 2 School Year; 5-Day Dosing|During the school year, all participants took their optimal dose determined during Phase 1 for the entire school year. These participants received medication on school-days only with drug holidays over weekends.
11177263|NCT02039908|OG000|Outcome|Methylphenidate 7-day Dosing|"During the school year, children in this arm will receive 7-day dosing of medication.~Methylphenidate: Children will receive a double-blind assessment to determine their optimal starting dose of Concerta. Doses will be adjusted over the course of the school year and inceased if tolerance to the medication is detected."
11177264|NCT02039908|OG001|Outcome|Methylphenidate 5-day Dosing|"During the school year phase, these children will receive 5-day dosing with weekend holidays.~Methylphenidate: Children will receive a double-blind assessment to determine their optimal starting dose of Concerta. Doses will be adjusted over the course of the school year and inceased if tolerance to the medication is detected."
11177265|NCT02039908|EG000|Reported Event|Phase 1-Medication First|In the first phase of the study, children participated in a crossover design of placebo and optimal-dose methylphenidate for 13 days in each condition. After a 9-day titration period, the Medication First group received methylphenidate for 13 days, a 2-day medication/placebo probe, a 2-day washout, then placebo for 13 days and a 2-day medication/placebo probe.
11177266|NCT02039908|EG001|Reported Event|Phase 1 - Placebo First|In the first phase of the study, children participated in a crossover design of placebo and optimal-dose methylphenidate for 13 days in each condition. After a 9-day titration period, the Placebo First group received placebo for 13 days, a 2-day medication/placebo probe, a 2-day washout, then optimal-dose medication for 13 days and a 2-day medication/placebo probe.
11177267|NCT02039908|EG002|Reported Event|Phase 2 - 7-Day Dosing|During the school year, all participants took their optimal dose determined in Phase 1 of the study for the entire school year. These participants received medication 7-days a week for the entire year
11177268|NCT02039908|EG003|Reported Event|Phase 2 - 5-Day Dosing|During the school year, all participants took their optimal dose determined during Phase 1 for the entire school year. These participants received medication on school-days only with drug holidays over weekends.
11177269|NCT02039947|BG000|Baseline|Cohort A|Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
11177270|NCT02039947|BG001|Baseline|Cohort B|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177271|NCT02039947|BG002|Baseline|Cohort C|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177272|NCT02039947|BG003|Baseline|Cohort D|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177273|NCT02039947|BG004|Baseline|Total|Total of all reporting groups
11177274|NCT02039947|FG000|Participant Flow|Cohort A|Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
11177275|NCT02039947|FG001|Participant Flow|Cohort B|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177276|NCT02039947|FG002|Participant Flow|Cohort C|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177277|NCT02039947|FG003|Participant Flow|Cohort D|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177278|NCT02039947|OG000|Outcome|Cohort A|Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
11177279|NCT02039947|OG000|Outcome|Cohort B|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177280|NCT02039947|OG001|Outcome|Cohort C|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177281|NCT02039947|OG002|Outcome|Cohort D|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177282|NCT02039947|OG001|Outcome|Cohort B|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177283|NCT02039947|OG002|Outcome|Cohort C|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177284|NCT02039947|OG003|Outcome|Cohort D|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177285|NCT02039947|EG000|Reported Event|Cohort A|Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
11177286|NCT02039947|EG001|Reported Event|Cohort B|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177287|NCT02039947|EG002|Reported Event|Cohort C|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177288|NCT02039947|EG003|Reported Event|Cohort D|Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
11177289|NCT02039947|EG004|Reported Event|Total|Total
11177290|NCT02040077|BG000|Baseline|Computer + Questions|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
11177291|NCT02040077|BG001|Baseline|Computer Only|Will receive computerized intervention with no embedded questions
11177292|NCT02040077|BG002|Baseline|Pamphlet|Receive a printed version of the same intervention
11177293|NCT02040077|BG003|Baseline|Total|Total of all reporting groups
11177294|NCT02040077|FG000|Participant Flow|Computer + Questions|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
11177295|NCT02040077|FG001|Participant Flow|Computer Only|Will receive computerized intervention with no embedded questions
11177296|NCT02040077|FG002|Participant Flow|Pamphlet|Receive a printed version of the same intervention
11177297|NCT02040077|OG000|Outcome|Computer + Mastery|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
11177298|NCT02040077|OG001|Outcome|Computer Only|Will receive computerized intervention with no embedded questions.
11177299|NCT02040077|OG002|Outcome|Pamphlet|Receive a printed version of the same intervention
11177300|NCT02040077|OG001|Outcome|Computer Only|Will receive computerized intervention with no embedded questions
10942559|NCT00770692|OG001|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
10942560|NCT00770692|OG002|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
10942561|NCT00770692|OG003|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
10942562|NCT00770692|EG000|Reported Event|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
10942563|NCT00770692|EG001|Reported Event|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
11177301|NCT02040077|EG000|Reported Event|Computer + Mastery|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
11177302|NCT02040077|EG001|Reported Event|Computer Only|Will receive computerized intervention with no embedded questions
11177303|NCT02040077|EG002|Reported Event|Pamphlet|Will receive an printed out version of the same intervention.
11177304|NCT02040090|BG000|Baseline|KamRAB|"KamRAB 20 IU/kg body weight via IM injection, once on Day 0~Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28"
11177305|NCT02040090|BG001|Baseline|HRIG Comparator Product|"FDA Approved Commercially Available HRIG Product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.~Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28"
10942564|NCT00770692|EG002|Reported Event|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
10942565|NCT00770692|EG003|Reported Event|Eszopiclone 2 mg Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
11177306|NCT02040090|BG002|Baseline|Total|Total of all reporting groups
11177307|NCT02040090|FG000|Participant Flow|KamRAB|"KamRAB 20 IU/kg body weight via IM injection, once on Day 0~Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28"
11177308|NCT02040090|FG001|Participant Flow|FDA Approved Commercially Available HRIG Product|"Comparator product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.~Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28"
11177309|NCT02040090|OG000|Outcome|KamRAB|"KamRAB 20 IU/kg body weight via IM injection, once on Day 0~Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28"
11177310|NCT02040090|OG001|Outcome|HRIG Comparator Product|"FDA Approved Commercially Available HRIG Product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.~Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28"
11177311|NCT02040090|EG000|Reported Event|KamRAB|"KamRAB 20 IU/kg body weight via IM injection, once on Day 0~Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28"
11177312|NCT02040090|EG001|Reported Event|FDA Approved Commercially Available HRIG Product|"Comparator product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.~Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28"
11177313|NCT02040116|BG000|Baseline|Rituximab Infusion|"Every patient is getting the same therapy of rituximab. If day 1 is tolerated at standard infusion then day 14 and beyond will be given as rapid infusion over 20 hours~Rapid Infusion Rituximab: Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion."
11177314|NCT02040116|FG000|Participant Flow|Rituximab Infusion|"Every patient is getting the same therapy of rituximab. If day 1 is tolerated at standard infusion then day 14 and beyond will be given as rapid infusion over 90 minutes~Rapid Infusion Rituximab: Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion."
10942566|NCT00770757|BG000|Baseline|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
10942567|NCT00770757|FG000|Participant Flow|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
10942568|NCT00770757|OG000|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
10942569|NCT00770757|EG000|Reported Event|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
10942570|NCT00770770|BG000|Baseline|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day~Fluocinolone Acetonide: 0.2 µg/day"
10942571|NCT00770770|BG001|Baseline|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day~Fluocinolone Acetonide: 0.5 µg/day"
10942572|NCT00770770|BG002|Baseline|Total|Total of all reporting groups
10942573|NCT00770770|FG000|Participant Flow|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
10942574|NCT00770770|FG001|Participant Flow|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
10942575|NCT00770770|OG000|Outcome|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day~Fluocinolone Acetonide: 0.2 µg/day"
10942576|NCT00770770|OG001|Outcome|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day~Fluocinolone Acetonide: 0.5 µg/day"
10942577|NCT00770770|EG000|Reported Event|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
10942578|NCT00770770|EG001|Reported Event|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
10942579|NCT00770861|BG000|Baseline|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
10942580|NCT00770861|BG001|Baseline|Placebo|Matching placebo tablets, oral administration
11177315|NCT02040116|OG000|Outcome|Number of Reactions for Standard Infusion|day 1 infusion of standard infusion will be given the same to all patients and then assessed
10942581|NCT00770861|BG002|Baseline|Total|Total of all reporting groups
10942582|NCT00770861|FG000|Participant Flow|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
10942583|NCT00770861|FG001|Participant Flow|Placebo|Matching placebo tablets, oral administration
10942584|NCT00770861|OG000|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
10942585|NCT00770861|OG001|Outcome|Placebo|Matching placebo tablets, oral administration
11177316|NCT02040116|OG001|Outcome|Number of Reactions for Rapid Infusion|day 1 infusion of rapid infusion will be given the same to all patients and then assessed
10942586|NCT00770861|EG000|Reported Event|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
10942587|NCT00770861|EG001|Reported Event|Placebo|Matching placebo tablets, oral administration
10942588|NCT00770874|BG000|Baseline|S-1 + Cisplatin (Arm A)|S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
10942589|NCT00770874|BG001|Baseline|Cisplatin (Arm B)|Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
10942590|NCT00770874|BG002|Baseline|Total|Total of all reporting groups
10942591|NCT00770874|FG000|Participant Flow|S-1 + Cisplatin (Arm A)|S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
10942592|NCT00770874|FG001|Participant Flow|Cisplatin (Arm B)|Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
10942593|NCT00770874|OG000|Outcome|S-1 + Cisplatin (Arm A)|S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
10942594|NCT00770874|OG001|Outcome|Cisplatin (Arm B)|Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
10942595|NCT00770874|EG000|Reported Event|S-1 + Cisplatin (Arm A)|S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
10942596|NCT00770874|EG001|Reported Event|Cisplatin (Arm B)|Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
10942597|NCT00770913|BG000|Baseline|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
10942598|NCT00770913|BG001|Baseline|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
10942599|NCT00770913|BG002|Baseline|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
10942600|NCT00770913|BG003|Baseline|Total|Total of all reporting groups
11177317|NCT02040116|OG000|Outcome|Time in Day Hospital|"The time of infusion will be recorded from the first dose and the second dose~Time in day hospital: time between the two doses will recorded"
11177318|NCT02040116|OG000|Outcome|Grade of Reactions for Standard Infusion|day 1 infusion of standard infusion will be graded according to CTCAE
11177319|NCT02040116|OG001|Outcome|Grade of Reactions for Rapid Infusion|day 14 infusion of standard infusion will be graded according to CTCAE
11177320|NCT02040116|EG000|Reported Event|Rituximab Infusion|"Every patient is getting the same therapy of rituximab. If day 1 is tolerated at standard infusion then day 14 and beyond will be given as rapid infusion over 20 hours~Rapid Infusion Rituximab: Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion."
11177321|NCT02040259|BG000|Baseline|Trevo Retriever|Mechanical thrombectomy, Trevo Retriever
11177322|NCT02040259|FG000|Participant Flow|Mechanical Thrombectomy, Trevo Retriever|The Trevo Retriever registry was a prospective, open-label, consecutive enrollment, multi-center global registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature be removing thrombus in subjects experiencing ischemic stroke
11177323|NCT02040259|OG000|Outcome|Mechanical Thrombectomy, Trevo Retriever|Study participants undergoing mechanical thrombectomy, with the Trevo Retriever
11177324|NCT02040259|OG000|Outcome|Mechanical Thrombectomy, Trevo Retriever|Study participants that have undergone mechanical thrombectomy with Trevo retriever with a completed modified Rankin Scale assessment at baseline and 90 days.
11177325|NCT02040259|OG000|Outcome|Mechanical Thrombectomy, Trevo Retriever|Study participants that have undergone mechanical thrombectomy with Trevo retriever.
11177326|NCT02040259|EG000|Reported Event|Mechanical Thrombectomy, Trevo Retriever|The Trevo Retriever registry was a prospective, open-label, consecutive enrollment, multi-center global registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature be removing thrombus in subjects experiencing ischemic stroke
11177327|NCT02040298|BG000|Baseline|Clemastine First, Then Placebo|Participants first received Clemastine 4mg tablet twice daily for 3 months, then they received Placebo (matching Clemastine 4mg) for 2 months.
11177328|NCT02040298|BG001|Baseline|Placebo First, Then Clemastine|Participants first received Placebo (matching Clemastine 4mg) tablet twice daily for 3 months, then they received Clemastine 4mg twice daily for 2 months.
11177329|NCT02040298|BG002|Baseline|Total|Total of all reporting groups
11177330|NCT02040298|FG000|Participant Flow|Clemastine First, Then Placebo|Participants first received Clemastine 4mg twice daily for 3 months. Then they received Placebo (matching Clemastine 4mg) twice daily for 2 months.
11177331|NCT02040298|FG001|Participant Flow|Placebo First, Then Clemastine|Participants first received Placebo (matching Clemastine 4mg) twice daily for 3 months. Then they received Clemastine 4mg twice daily for 2 months.
11177332|NCT02040298|OG000|Outcome|Clemastine|Participants who received clemastine 4mg twice daily in either the first 3 months or the last 2 months of the study
11177333|NCT02040298|OG001|Outcome|Placebo|Participants who received Placebo tablet (matching clemastine 4mg) twice daily in either the first 3 months or last 2 months of the study.
11177334|NCT02040298|OG000|Outcome|Clemastine|Participants who received clemastine 4mg tablet twice a day either the first 3 months or last 2 months of the study.
11177335|NCT02040298|OG001|Outcome|Placebo|Participants who received Placebo (matching clemastine 4mg) twice a day in either the first 3 months or last 2 months of the study.
11177336|NCT02040298|OG000|Outcome|Clemastine|Participants who received Clemastine 4mg tablet twice daily in either the first 3 months or the last 2 months of the study.
11177337|NCT02040298|OG001|Outcome|Placebo|Participants who received Placebo (matching clemastine 4mg tablet) in either the first 3 months or the last 2 months of the study.
11177338|NCT02040298|OG000|Outcome|Clemastine|Participants who received Clemastine 4mg tablet twice daily in either the first 3 months or last 2 months of the study.
11177339|NCT02040298|OG001|Outcome|Placebo|Participants who received Placebo (matching Clemastine 4mg) in either the first 3 months or last 2 months of the study.
11177340|NCT02040298|EG000|Reported Event|Clemastine|Participants received Clemastine 4mg twice daily for either 3 months or 2 months.
11177341|NCT02040298|EG001|Reported Event|Placebo|Participants received Placebo (matching Clemastine 4mg) for either 3 months or 2 months.
11177342|NCT02040428|BG000|Baseline|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11177343|NCT02040428|BG001|Baseline|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
11177344|NCT02040428|BG002|Baseline|Total|Total of all reporting groups
11177345|NCT02040428|FG000|Participant Flow|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11177346|NCT02040428|FG001|Participant Flow|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
11177347|NCT02040428|OG000|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11177348|NCT02040428|OG001|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
11177349|NCT02040428|EG000|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
11177350|NCT02040428|EG001|Reported Event|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
11177351|NCT02040532|BG000|Baseline|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
10942601|NCT00770913|FG000|Participant Flow|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
10942602|NCT00770913|FG001|Participant Flow|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
10942603|NCT00770913|FG002|Participant Flow|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
10942604|NCT00770913|OG000|Outcome|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
10942605|NCT00770913|OG001|Outcome|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
10942606|NCT00770913|OG002|Outcome|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
10942607|NCT00770913|EG000|Reported Event|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
10942608|NCT00770913|EG001|Reported Event|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
10942609|NCT00770913|EG002|Reported Event|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
10942610|NCT00770991|BG000|Baseline|Two Berry Suppositories Bedtime Plus Oral Berry Powder|20 g of lyophilized berry powder administered orally 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
10942611|NCT00770991|BG001|Baseline|Two Berry Suppositories Bedtime Plus Placebo Powder|20 g of placebo powder administered as an oral slurry 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
10942612|NCT00770991|BG002|Baseline|Total|Total of all reporting groups
10942613|NCT00770991|FG000|Participant Flow|Placebo Powder Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
10942614|NCT00770991|FG001|Participant Flow|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
10942615|NCT00770991|OG000|Outcome|Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo|Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .
10942616|NCT00770991|OG001|Outcome|Lypholized BRB Suppositiry Plus BRB Slurry|2 lyphilized black raspberry suppositories plus black raspberry slurry.
10942617|NCT00770991|OG002|Outcome|All Participants|
11177352|NCT02040532|FG000|Participant Flow|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
10942618|NCT00770991|OG000|Outcome|Normal Mucosa|all participants combined for this analysis. Sample of normal mucosa
10942619|NCT00770991|OG001|Outcome|Polyp|all participants used for this analysis
10942620|NCT00770991|OG000|Outcome|Lyophilized Black Raspberry (BRB) Suppositories + Placebo|Two, 730 mg BRB suppositories administered at bedtime.
10942621|NCT00770991|OG001|Outcome|Lyophilized BRB Suppositories + BRB Slurry|
10942622|NCT00770991|EG000|Reported Event|Black Raspberry Placebo Slurry Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
10942623|NCT00770991|EG001|Reported Event|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
10942624|NCT00771030|BG000|Baseline|Placebo SC (Cohorts 1-3)|Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
10942625|NCT00771030|BG001|Baseline|Placebo IV (Cohorts 5-6)|Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
10942626|NCT00771030|BG002|Baseline|Brodalumab 50 mg SC (Cohort 1)|Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942627|NCT00771030|BG003|Baseline|Brodalumab 140 mg SC (Cohort 2)|Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942628|NCT00771030|BG004|Baseline|Brodalumab 210 mg SC (Cohort 3)|Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942629|NCT00771030|BG005|Baseline|Brodalumab 420 mg IV (Cohort 5)|Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942630|NCT00771030|BG006|Baseline|Brodalumab 700 mg IV (Cohort 6)|Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942631|NCT00771030|BG007|Baseline|Total|Total of all reporting groups
10942632|NCT00771030|FG000|Participant Flow|Placebo SC (Cohorts 1-3)|Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
10942633|NCT00771030|FG001|Participant Flow|Placebo IV (Cohorts 5-6)|Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
10942634|NCT00771030|FG002|Participant Flow|Brodalumab 50 mg SC (Cohort 1)|Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942635|NCT00771030|FG003|Participant Flow|Brodalumab 140 mg SC (Cohort 2)|Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942636|NCT00771030|FG004|Participant Flow|Brodalumab 210 mg SC (Cohort 3)|Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942637|NCT00771030|FG005|Participant Flow|Brodalumab 420 mg IV (Cohort 5)|Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942638|NCT00771030|FG006|Participant Flow|Brodalumab 700 mg IV (Cohort 6)|Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942639|NCT00771030|OG000|Outcome|Placebo SC (Cohorts 1-3)|Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
10942640|NCT00771030|OG001|Outcome|Placebo IV (Cohorts 5-6)|Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
10942641|NCT00771030|OG002|Outcome|Brodalumab 50 mg SC (Cohort 1)|Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942642|NCT00771030|OG003|Outcome|Brodalumab 140 mg SC (Cohort 2)|Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942643|NCT00771030|OG004|Outcome|Brodalumab 210 mg SC (Cohort 3)|Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942644|NCT00771030|OG005|Outcome|Brodalumab 420 mg IV (Cohort 5)|Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942645|NCT00771030|OG006|Outcome|Brodalumab 700 mg IV (Cohort 6)|Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942646|NCT00771030|OG000|Outcome|Brodalumab 50 mg SC (Cohort 1)|Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942647|NCT00771030|OG001|Outcome|Brodalumab 140 mg SC (Cohort 2)|Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942648|NCT00771030|OG002|Outcome|Brodalumab 210 mg SC (Cohort 3)|Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942649|NCT00771030|OG000|Outcome|Brodalumab 420 mg IV (Cohort 5)|Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942650|NCT00771030|OG001|Outcome|Brodalumab 700 mg IV (Cohort 6)|Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942651|NCT00771030|EG000|Reported Event|Placebo SC (Cohorts 1-3)|Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
10942652|NCT00771030|EG001|Reported Event|Placebo IV (Cohorts 5-6)|Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
10942653|NCT00771030|EG002|Reported Event|Brodalumab 50 mg SC (Cohort 1)|Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942654|NCT00771030|EG003|Reported Event|Brodalumab 140 mg SC (Cohort 2)|Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942655|NCT00771030|EG004|Reported Event|Brodalumab 210 mg SC (Cohort 3)|Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
10942656|NCT00771030|EG005|Reported Event|Brodalumab 420 mg IV (Cohort 5)|Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942657|NCT00771030|EG006|Reported Event|Brodalumab 700 mg IV (Cohort 6)|Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
10942658|NCT00771056|BG000|Baseline|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
10942659|NCT00771056|FG000|Participant Flow|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
10942660|NCT00771056|OG000|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
10942661|NCT00771056|EG000|Reported Event|Hydroxychloroquine|"Hydroxychloroquine 400 mg po daily for up to one year.~Hydroxychloroquine: 400mg by mouth daily x 1 year"
10942662|NCT00771173|BG000|Baseline|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
10942663|NCT00771173|BG001|Baseline|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
10942664|NCT00771173|BG002|Baseline|Total|Total of all reporting groups
11177353|NCT02040532|OG000|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
10942665|NCT00771173|FG000|Participant Flow|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Blinding: The research pharmacist has facilitated the blinding by placing the active agent (200 mg tablets) into a solid colored capsule. She will make matching placebo capsules filled with lactose powder. To aid in blinding and avoid systemic administration of other dye agents for women in the placebo group, a small amount of orange dye will be placed in the Foley bag. This has been tested in the planning for this trial and is known effectively color the urine orange."
10942666|NCT00771173|FG001|Participant Flow|Active Agent Group|Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
10942667|NCT00771173|OG000|Outcome|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
10942668|NCT00771173|OG001|Outcome|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
10942669|NCT00771173|EG000|Reported Event|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
10942670|NCT00771173|EG001|Reported Event|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
10942671|NCT00771238|BG000|Baseline|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
10942672|NCT00771238|BG001|Baseline|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
10942673|NCT00771238|BG002|Baseline|Total|Total of all reporting groups
10942674|NCT00771238|FG000|Participant Flow|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
10942675|NCT00771238|FG001|Participant Flow|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
10942676|NCT00771238|OG000|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
10942677|NCT00771238|OG001|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
10942678|NCT00771238|EG000|Reported Event|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
11177354|NCT02040532|EG000|Reported Event|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
11177355|NCT02040623|BG000|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
11177356|NCT02040623|BG001|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
11177357|NCT02040623|BG002|Baseline|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
11177358|NCT02040623|BG003|Baseline|Total|Total of all reporting groups
11177359|NCT02040623|FG000|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
10942679|NCT00771238|EG001|Reported Event|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
10942680|NCT00771264|BG000|Baseline|Urgent PC|
10942681|NCT00771264|BG001|Baseline|Sham / Placebo|
10942682|NCT00771264|BG002|Baseline|Total|Total of all reporting groups
10942683|NCT00771264|FG000|Participant Flow|Urgent PC|
10942684|NCT00771264|FG001|Participant Flow|Sham / Placebo|
10942685|NCT00771264|OG000|Outcome|Urgent PC|
10942686|NCT00771264|OG001|Outcome|Sham / Placebo|
10942687|NCT00771264|EG000|Reported Event|Urgent PC|
10942688|NCT00771264|EG001|Reported Event|Sham / Placebo|
10942689|NCT00771277|BG000|Baseline|Arm 1|Family experience of concerns and providing support to TBI patient
10942690|NCT00771277|FG000|Participant Flow|Arm 1|"Use of volunteer support teams to provide services~Support Teams: Use of volunteers organized into teams with a coordinator to provide services to TBI family"
10942691|NCT00771277|OG000|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
10942692|NCT00771277|EG000|Reported Event|TBI Caregivers|Family caregivers providing support to TBI patients.
10942693|NCT00771407|BG000|Baseline|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
10942694|NCT00771407|BG001|Baseline|Standard Ostomy Construction|Ostomy created in the standard fashion
10942695|NCT00771407|BG002|Baseline|Total|Total of all reporting groups
10942696|NCT00771407|FG000|Participant Flow|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
10942697|NCT00771407|FG001|Participant Flow|Standard Ostomy Construction|Ostomy created in the standard fashion
10942698|NCT00771407|OG000|Outcome|Strattice Fascial Inlay|Strattice will be placed as a fascial inlay to support the ostomy site
10942699|NCT00771407|OG001|Outcome|Standard Ostomy Construction|Ostomy will be created in the standard fashion
10942700|NCT00771407|EG000|Reported Event|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
10942701|NCT00771407|EG001|Reported Event|Standard Ostomy Construction|Ostomy created in the standard fashion
10942702|NCT00771472|BG000|Baseline|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
10942703|NCT00771472|FG000|Participant Flow|Part I|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
10942704|NCT00771472|FG001|Participant Flow|Part II|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
10942705|NCT00771472|OG000|Outcome|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
10942706|NCT00771472|OG000|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
10942707|NCT00771472|EG000|Reported Event|Vorinostat|Parts I & II: vorinostat(400 mg) Oral, daily (QD). Treatment period was 28 days per cycle.
10942708|NCT00771537|BG000|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942709|NCT00771537|BG001|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942710|NCT00771537|BG002|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
10942711|NCT00771537|BG003|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
10942712|NCT00771537|BG004|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942713|NCT00771537|BG005|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942714|NCT00771537|BG006|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942715|NCT00771537|BG007|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942716|NCT00771537|BG008|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942717|NCT00771537|BG009|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942718|NCT00771537|BG010|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942719|NCT00771537|BG011|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942720|NCT00771537|BG012|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942721|NCT00771537|BG013|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942722|NCT00771537|BG014|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942723|NCT00771537|BG015|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942724|NCT00771537|BG016|Baseline|Total|Total of all reporting groups
11177360|NCT02040623|FG001|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
11177361|NCT02040623|FG002|Participant Flow|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
11177362|NCT02040623|OG000|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
11177363|NCT02040623|OG001|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
11177364|NCT02040623|OG002|Outcome|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
10942725|NCT00771537|FG000|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942726|NCT00771537|FG001|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942727|NCT00771537|FG002|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942728|NCT00771537|FG003|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942729|NCT00771537|FG004|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942730|NCT00771537|FG005|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942731|NCT00771537|FG006|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942732|NCT00771537|FG007|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942733|NCT00771537|FG008|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942734|NCT00771537|FG009|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942735|NCT00771537|FG010|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942736|NCT00771537|FG011|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942737|NCT00771537|FG012|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942738|NCT00771537|FG013|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942739|NCT00771537|FG014|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942740|NCT00771537|FG015|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942741|NCT00771537|OG000|Outcome|Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942742|NCT00771537|OG001|Outcome|1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942743|NCT00771537|OG002|Outcome|2-Sided Trivial|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942744|NCT00771537|OG003|Outcome|2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942745|NCT00771537|OG000|Outcome|Control/Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942746|NCT00771537|OG001|Outcome|1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
11177365|NCT02040623|EG000|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
10942747|NCT00771537|OG002|Outcome|2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
10942748|NCT00771537|OG003|Outcome|2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
10942749|NCT00771537|EG000|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942750|NCT00771537|EG001|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942751|NCT00771537|EG002|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
10942752|NCT00771537|EG003|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
10942753|NCT00771537|EG004|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942754|NCT00771537|EG005|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942755|NCT00771537|EG006|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942756|NCT00771537|EG007|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942757|NCT00771537|EG008|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942758|NCT00771537|EG009|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942759|NCT00771537|EG010|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
11177366|NCT02040623|EG001|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
11177367|NCT02040623|EG002|Reported Event|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
11177368|NCT02040766|BG000|Baseline|Placebo BAI and MDI|"Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177369|NCT02040766|BG001|Baseline|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).~Placebo MDI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
10942760|NCT00771537|EG011|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942761|NCT00771537|EG012|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
10942762|NCT00771537|EG013|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942763|NCT00771537|EG014|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942764|NCT00771537|EG015|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
10942765|NCT00771615|BG000|Baseline|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942766|NCT00771615|BG001|Baseline|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942767|NCT00771615|BG002|Baseline|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942768|NCT00771615|BG003|Baseline|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942769|NCT00771615|BG004|Baseline|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942770|NCT00771615|BG005|Baseline|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942771|NCT00771615|BG006|Baseline|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942772|NCT00771615|BG007|Baseline|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942773|NCT00771615|BG008|Baseline|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942774|NCT00771615|BG009|Baseline|Total|Total of all reporting groups
11177370|NCT02040766|BG002|Baseline|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).~Placebo MDI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177371|NCT02040766|BG003|Baseline|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).~Placebo BAI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
10942775|NCT00771615|FG000|Participant Flow|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942776|NCT00771615|FG001|Participant Flow|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942777|NCT00771615|FG002|Participant Flow|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942778|NCT00771615|FG003|Participant Flow|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942779|NCT00771615|FG004|Participant Flow|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942780|NCT00771615|FG005|Participant Flow|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942781|NCT00771615|FG006|Participant Flow|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942782|NCT00771615|FG007|Participant Flow|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942783|NCT00771615|FG008|Participant Flow|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942784|NCT00771615|OG000|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942785|NCT00771615|OG001|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
10942786|NCT00771615|OG002|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
11177372|NCT02040766|BG004|Baseline|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).~Placebo BAI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
10963474|NCT00872170|EG000|Reported Event|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
11177373|NCT02040766|BG005|Baseline|Total|Total of all reporting groups
10942787|NCT00771615|OG003|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
10942788|NCT00771615|OG004|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
10942789|NCT00771615|OG005|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
10942790|NCT00771615|OG006|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
10942791|NCT00771615|OG007|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
10942792|NCT00771615|OG008|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
10942793|NCT00771615|OG000|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942794|NCT00771615|OG001|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942795|NCT00771615|OG002|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942796|NCT00771615|OG003|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942797|NCT00771615|OG004|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942798|NCT00771615|OG005|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942799|NCT00771615|OG006|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942800|NCT00771615|OG007|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942801|NCT00771615|OG008|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942802|NCT00771615|EG000|Reported Event|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942803|NCT00771615|EG001|Reported Event|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942804|NCT00771615|EG002|Reported Event|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942805|NCT00771615|EG003|Reported Event|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942806|NCT00771615|EG004|Reported Event|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942807|NCT00771615|EG005|Reported Event|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942808|NCT00771615|EG006|Reported Event|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942809|NCT00771615|EG007|Reported Event|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942810|NCT00771615|EG008|Reported Event|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
10942811|NCT00771667|BG000|Baseline|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
10942812|NCT00771667|BG001|Baseline|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
10942813|NCT00771667|BG002|Baseline|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
10942814|NCT00771667|BG003|Baseline|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
10942815|NCT00771667|BG004|Baseline|Total|Total of all reporting groups
10942816|NCT00771667|FG000|Participant Flow|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
10942817|NCT00771667|FG001|Participant Flow|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
10942818|NCT00771667|FG002|Participant Flow|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
10942819|NCT00771667|FG003|Participant Flow|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
10942820|NCT00771667|FG004|Participant Flow|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
10942821|NCT00771667|FG005|Participant Flow|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
10942822|NCT00771667|FG006|Participant Flow|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
10942823|NCT00771667|FG007|Participant Flow|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
10942824|NCT00771667|FG008|Participant Flow|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
10942825|NCT00771667|FG009|Participant Flow|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
10942826|NCT00771667|OG000|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
10942827|NCT00771667|OG001|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
10942828|NCT00771667|OG002|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
10942829|NCT00771667|OG003|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
10942830|NCT00771667|OG000|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
10942831|NCT00771667|OG001|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
10942832|NCT00771667|EG000|Reported Event|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
10942833|NCT00771667|EG001|Reported Event|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
10942834|NCT00771667|EG002|Reported Event|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
10942835|NCT00771667|EG003|Reported Event|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
10942836|NCT00771667|EG004|Reported Event|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
10942837|NCT00771667|EG005|Reported Event|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
10942838|NCT00771667|EG006|Reported Event|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
10942839|NCT00771667|EG007|Reported Event|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
10942840|NCT00771667|EG008|Reported Event|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
10942841|NCT00771667|EG009|Reported Event|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
10942842|NCT00771745|BG000|Baseline|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
10942843|NCT00771745|BG001|Baseline|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
10942844|NCT00771745|BG002|Baseline|Total|Total of all reporting groups
10942845|NCT00771745|FG000|Participant Flow|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
10942846|NCT00771745|FG001|Participant Flow|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
10942847|NCT00771745|OG000|Outcome|Preloading Induction With Thymoglobulin x 4 Doses|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
10942848|NCT00771745|OG001|Outcome|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
10942849|NCT00771745|EG000|Reported Event|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
10942850|NCT00771745|EG001|Reported Event|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
10942851|NCT00771758|BG000|Baseline|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
10942852|NCT00771758|BG001|Baseline|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
10942853|NCT00771758|BG002|Baseline|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
10942854|NCT00771758|BG003|Baseline|Total|Total of all reporting groups
10942855|NCT00771758|FG000|Participant Flow|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
10942856|NCT00771758|FG001|Participant Flow|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
10942857|NCT00771758|FG002|Participant Flow|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
10942858|NCT00771758|OG000|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
10942859|NCT00771758|OG001|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
10942860|NCT00771758|OG002|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
10942861|NCT00771758|OG000|Outcome|Excellent - End of Study|Tapentadol IR
10942862|NCT00771758|OG001|Outcome|Good - End of Study|Tapentadol IR
10942863|NCT00771758|OG002|Outcome|Fair - End of Study|Tapentadol IR
10942864|NCT00771758|OG003|Outcome|Poor - End of Study|Tapentadol IR
10942865|NCT00771758|OG004|Outcome|Missing - End of Study|Tapentadol IR
10942866|NCT00771758|OG005|Outcome|Baseline Total|Tapentadol IR
10942867|NCT00771758|OG000|Outcome|Excellent - End of Study|Oxycodone IR
10942868|NCT00771758|OG001|Outcome|Good - End of Study|Oxycodone IR
10942869|NCT00771758|OG002|Outcome|Fair - End of Study|Oxycodone IR
10942870|NCT00771758|OG003|Outcome|Poor - End of Study|Oxycodone IR
10942871|NCT00771758|OG004|Outcome|Missing - End of Study|Oxycodone IR
10942872|NCT00771758|OG005|Outcome|Baseline Total|Oxycodone IR
10942873|NCT00771758|OG000|Outcome|Excellent - End of Study|Placebo
10942874|NCT00771758|OG001|Outcome|Good - End of Study|Placebo
10942875|NCT00771758|OG002|Outcome|Fair - End of Study|Placebo
10942876|NCT00771758|OG003|Outcome|Poor - End of Study|Placebo
10942877|NCT00771758|OG004|Outcome|Baseline Total|Placebo
10942878|NCT00771758|EG000|Reported Event|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
10942879|NCT00771758|EG001|Reported Event|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
10942880|NCT00771758|EG002|Reported Event|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
10942881|NCT00771810|BG000|Baseline|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
10942882|NCT00771810|BG001|Baseline|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
10942883|NCT00771810|BG002|Baseline|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
10942884|NCT00771810|BG003|Baseline|Total|Total of all reporting groups
10942885|NCT00771810|FG000|Participant Flow|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
10942886|NCT00771810|FG001|Participant Flow|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
10942887|NCT00771810|FG002|Participant Flow|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
10942888|NCT00771810|OG000|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
10942889|NCT00771810|OG001|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
10942890|NCT00771810|OG002|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
10942891|NCT00771810|OG002|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
10942892|NCT00771810|EG000|Reported Event|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
10942893|NCT00771810|EG001|Reported Event|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
10942894|NCT00771810|EG002|Reported Event|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
10942895|NCT00771849|BG000|Baseline|Menactra® Vaccine Group|Participants received Menactra® Vaccine
10942896|NCT00771849|BG001|Baseline|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
10942897|NCT00771849|BG002|Baseline|Total|Total of all reporting groups
10942898|NCT00771849|FG000|Participant Flow|Menactra® Vaccine Group|Participants received Menactra® Vaccine
10942899|NCT00771849|FG001|Participant Flow|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
10942900|NCT00771849|OG000|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
10942901|NCT00771849|OG001|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
10942902|NCT00771849|EG000|Reported Event|Menactra® Vaccine Group|Participants received Menactra® Vaccine
10942903|NCT00771849|EG001|Reported Event|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
10942904|NCT00771875|BG000|Baseline|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
10942905|NCT00771875|BG001|Baseline|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
10942906|NCT00771875|BG002|Baseline|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
10942907|NCT00771875|BG003|Baseline|Total|Total of all reporting groups
10963475|NCT00872170|EG001|Reported Event|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
10942908|NCT00771875|FG000|Participant Flow|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on cluster of differentiation 3 (CD3) count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via intravenous push (IVP) over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
10942909|NCT00771875|FG001|Participant Flow|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
10942910|NCT00771875|FG002|Participant Flow|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
10942911|NCT00771875|OG000|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
10942912|NCT00771875|OG001|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
10942913|NCT00771875|OG002|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
10942914|NCT00771875|EG000|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
10942915|NCT00771875|EG001|Reported Event|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
10942916|NCT00771875|EG002|Reported Event|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
10942917|NCT00771901|BG000|Baseline|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
10942918|NCT00771901|BG001|Baseline|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
10942919|NCT00771901|BG002|Baseline|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
10942920|NCT00771901|BG003|Baseline|Total|Total of all reporting groups
10942921|NCT00771901|FG000|Participant Flow|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
10942922|NCT00771901|FG001|Participant Flow|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
10942923|NCT00771901|FG002|Participant Flow|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
10942924|NCT00771901|OG000|Outcome|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
10942925|NCT00771901|OG001|Outcome|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
10942926|NCT00771901|OG002|Outcome|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
10942927|NCT00771901|EG000|Reported Event|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
10942928|NCT00771901|EG001|Reported Event|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
10942929|NCT00771901|EG002|Reported Event|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
10942930|NCT00771914|BG000|Baseline|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
10942931|NCT00771914|BG001|Baseline|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
10942932|NCT00771914|BG002|Baseline|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
10942933|NCT00771914|BG003|Baseline|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
10942934|NCT00771914|BG004|Baseline|Total|Total of all reporting groups
10942935|NCT00771914|FG000|Participant Flow|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
10942936|NCT00771914|FG001|Participant Flow|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza, then 4 grams of Lovaza, then 81mg of Aspirin
10942937|NCT00771914|FG002|Participant Flow|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81 mg of Aspirin
10942938|NCT00771914|FG003|Participant Flow|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
10942939|NCT00771914|OG000|Outcome|Placebo|All participants received Placebo intervention regardless of sequence.
10942940|NCT00771914|OG001|Outcome|Aspirin|All participants received Aspirin intervention regardless of sequence.
10942941|NCT00771914|OG002|Outcome|Lovaza|All participants received Lovaza intervention regardless of sequence.
10942942|NCT00771914|OG003|Outcome|Both Aspirin and Lovaza|All participants received Aspirin and Lovaza intervention regardless of sequence.
10942943|NCT00771914|EG000|Reported Event|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
10942944|NCT00771914|EG001|Reported Event|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
10942945|NCT00771914|EG002|Reported Event|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
10942946|NCT00771914|EG003|Reported Event|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
10942947|NCT00771927|BG000|Baseline|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
10942948|NCT00771927|BG001|Baseline|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
10942949|NCT00771927|BG002|Baseline|Total|Total of all reporting groups
10942950|NCT00771927|FG000|Participant Flow|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
10942951|NCT00771927|FG001|Participant Flow|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
10942952|NCT00771927|OG000|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
10942953|NCT00771927|OG001|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
10942954|NCT00771927|EG000|Reported Event|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
10942955|NCT00771927|EG001|Reported Event|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
10942956|NCT00771953|BG000|Baseline|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
10942957|NCT00771953|BG001|Baseline|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
10942958|NCT00771953|BG002|Baseline|Total|Total of all reporting groups
10942959|NCT00771953|FG000|Participant Flow|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
10942960|NCT00771953|FG001|Participant Flow|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
10942961|NCT00771953|OG000|Outcome|Apricoxib Plus Docetaxel|Apricoxib 400mg qd plus docetaxel 75mg/m2 q21 days
10942962|NCT00771953|OG001|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel 75mg/m2 q21 days
10942963|NCT00771953|OG002|Outcome|Apricoxib Plus Pemetrexed|Apricoxib 400mg qd plus pemetrexed 500mg/m2 q21 days
10942964|NCT00771953|OG003|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed 500mg/m2 q21 days
10942965|NCT00771953|EG000|Reported Event|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
10942966|NCT00771953|EG001|Reported Event|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
10942967|NCT00772005|BG000|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942968|NCT00772005|BG001|Baseline|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942969|NCT00772005|BG002|Baseline|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10963476|NCT00872339|BG000|Baseline|Transfusion-dependant|People with transfusion-dependant thalassemia.
10942970|NCT00772005|BG003|Baseline|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942971|NCT00772005|BG004|Baseline|Total|Total of all reporting groups
10942972|NCT00772005|FG000|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942973|NCT00772005|FG001|Participant Flow|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942974|NCT00772005|FG002|Participant Flow|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942975|NCT00772005|FG003|Participant Flow|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942976|NCT00772005|OG000|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942977|NCT00772005|OG001|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942978|NCT00772005|OG002|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942979|NCT00772005|OG003|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942980|NCT00772005|EG000|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942981|NCT00772005|EG001|Reported Event|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10963477|NCT00872339|BG001|Baseline|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
10963478|NCT00872339|BG002|Baseline|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
10942982|NCT00772005|EG002|Reported Event|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942983|NCT00772005|EG003|Reported Event|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
10942984|NCT00772031|BG000|Baseline|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
10942985|NCT00772031|BG001|Baseline|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
10942986|NCT00772031|BG002|Baseline|Total|Total of all reporting groups
10942987|NCT00772031|FG000|Participant Flow|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
10942988|NCT00772031|FG001|Participant Flow|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
10942989|NCT00772031|OG000|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
10942990|NCT00772031|OG001|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
10942991|NCT00772031|OG000|Outcome|Topiramate Plus Proporanolol|Participants will receive propranolol and topiramate.
10942992|NCT00772031|OG001|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
10942993|NCT00772031|OG000|Outcome|Topiramate Plus Propranolol, no Prior, Stable Topiramate|Participants without prior stable topiramate use received propranolol and topiramate.
10942994|NCT00772031|OG001|Outcome|Topiramate Plus Placebo, no Prior, Stable Topiramate|Participants without prior stable topiramate use received a placebo and topiramate.
10942995|NCT00772031|OG002|Outcome|Topiramate Plus Propranolol, Prior, Stable Topiramate|Participants with prior stable topiramate use received propranolol and topiramate.
10942996|NCT00772031|OG003|Outcome|Topiramate Plus Placebo, Prior, Stable Topiramate|Participants with prior stable topiramate use received a placebo and topiramate.
10942997|NCT00772031|EG000|Reported Event|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
10942998|NCT00772031|EG001|Reported Event|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
10942999|NCT00772070|BG000|Baseline|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
10943000|NCT00772070|BG001|Baseline|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
10943001|NCT00772070|BG002|Baseline|Total|Total of all reporting groups
10943002|NCT00772070|FG000|Participant Flow|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
10943003|NCT00772070|FG001|Participant Flow|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
10943004|NCT00772070|OG000|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
10943005|NCT00772070|OG001|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
10943006|NCT00772070|EG000|Reported Event|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
10943007|NCT00772070|EG001|Reported Event|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
10943008|NCT00772109|BG000|Baseline|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
10943009|NCT00772109|BG001|Baseline|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
10943010|NCT00772109|BG002|Baseline|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
10943011|NCT00772109|BG003|Baseline|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
10943012|NCT00772109|BG004|Baseline|Total|Total of all reporting groups
10943013|NCT00772109|FG000|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
10943014|NCT00772109|FG001|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
10943015|NCT00772109|FG002|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
10943016|NCT00772109|FG003|Participant Flow|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
10943017|NCT00772109|OG000|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
10943018|NCT00772109|OG001|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
10943019|NCT00772109|OG002|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
10943020|NCT00772109|OG003|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
10943021|NCT00772109|EG000|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
10943022|NCT00772109|EG001|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
10943023|NCT00772109|EG002|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
10943024|NCT00772109|EG003|Reported Event|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
10943025|NCT00772148|BG000|Baseline|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
10943026|NCT00772148|BG001|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
10943027|NCT00772148|BG002|Baseline|Total|Total of all reporting groups
10943028|NCT00772148|FG000|Participant Flow|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
10943029|NCT00772148|FG001|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
10943030|NCT00772148|OG000|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
10943031|NCT00772148|OG001|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
10943032|NCT00772148|EG000|Reported Event|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
10943033|NCT00772148|EG001|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
10943034|NCT00772304|BG000|Baseline|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
10943035|NCT00772304|FG000|Participant Flow|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
10943036|NCT00772304|OG000|Outcome|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
10943037|NCT00772304|EG000|Reported Event|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
10943038|NCT00772330|BG000|Baseline|Patient With Primary Open Angle Glaucoma (POAG)|Patient with primary open angle glaucoma (POAG) inadequately controlled on tolerated medical therapy with IOP ≥ 18mmHg and ≤ 40 mmHg
10943039|NCT00772330|FG000|Participant Flow|MIDI Arrow|Eligible patients with POAG were implanted with a MicroShunt in the anterior chamber of the eye
10943040|NCT00772330|OG000|Outcome|To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma|To Assess safety and performance of the MIDI arrow in patients suffering from Glaucoma inadequately controlled on medical therapy with IOP >/= 18mmHg and </= 40mmHg
10943041|NCT00772330|OG000|Outcome|MIDI Arrow|Eligible patients with POAG were implanted with a MicroShunt in the anterior chamber of the eye
10943042|NCT00772330|OG000|Outcome|MIDI Arrow|"Ab externo glaucoma drainage device with no reservoir~Glaucoma Drainage Device: Insertion of MIDI Arrow subconjunctivally with a fornix-based incision after pretreatment of scleral surface with 0.4 mg/mL MMC and insertion of MIDI Arrow tube through sclera into anterior chamber of eye"
10943043|NCT00772330|OG000|Outcome|The Number of Glaucoma Supplemental Medication|the number of glaucoma supplemental medications required after the MicroShunt procedure
10943044|NCT00772330|EG000|Reported Event|Patient With Primary Open Angle Glaucoma (POAG)|Patient with primary open angle glaucoma (POAG) inadequately controlled on tolerated medical therapy with IOP ≥ 18mmHg and ≤ 40 mmHg
10943045|NCT00772369|BG000|Baseline|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
10943046|NCT00772369|FG000|Participant Flow|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
10943047|NCT00772369|OG000|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
10943048|NCT00772369|EG000|Reported Event|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
10943049|NCT00772382|BG000|Baseline|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
10943050|NCT00772382|FG000|Participant Flow|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
10943051|NCT00772382|OG000|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
10943052|NCT00772382|EG000|Reported Event|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
10943053|NCT00772447|BG000|Baseline|Daptomycin|daptomycin 4mg/kg iv every 24hours
10943054|NCT00772447|BG001|Baseline|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
10943055|NCT00772447|BG002|Baseline|Total|Total of all reporting groups
10943056|NCT00772447|FG000|Participant Flow|Daptomycin|daptomycin 4mg/kg iv every 24hours
10943057|NCT00772447|FG001|Participant Flow|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
10943058|NCT00772447|OG000|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
10943059|NCT00772447|OG001|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
10943060|NCT00772447|OG001|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
10943061|NCT00772447|EG000|Reported Event|Daptomycin|daptomycin 4mg/kg iv every 24hours
10943062|NCT00772447|EG001|Reported Event|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
10943063|NCT00772538|BG000|Baseline|Placebo|Patients treated with matching placebo
10943064|NCT00772538|BG001|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
10943065|NCT00772538|BG002|Baseline|Total|Total of all reporting groups
10943066|NCT00772538|FG000|Participant Flow|Placebo|Patients treated with matching placebo
10943067|NCT00772538|FG001|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
10943068|NCT00772538|OG000|Outcome|Placebo|Patients treated with matching placebo
10943069|NCT00772538|OG001|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
10943070|NCT00772538|EG000|Reported Event|Placebo|Patients treated with matching placebo
10943071|NCT00772538|EG001|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 Î¼g qd
10943072|NCT00772577|BG000|Baseline|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
10943073|NCT00772577|BG001|Baseline|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
10943074|NCT00772577|BG002|Baseline|Total|Total of all reporting groups
10943075|NCT00772577|FG000|Participant Flow|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
10943076|NCT00772577|FG001|Participant Flow|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
10943077|NCT00772577|OG000|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
10943078|NCT00772577|OG001|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
10943079|NCT00772577|EG000|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
10943080|NCT00772577|EG001|Reported Event|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
10943081|NCT00772590|BG000|Baseline|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
10943082|NCT00772590|BG001|Baseline|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
10943083|NCT00772590|BG002|Baseline|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
10943084|NCT00772590|BG003|Baseline|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
10943085|NCT00772590|BG004|Baseline|Total|Total of all reporting groups
10943086|NCT00772590|FG000|Participant Flow|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
10943087|NCT00772590|FG001|Participant Flow|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
10943088|NCT00772590|FG002|Participant Flow|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
10943089|NCT00772590|FG003|Participant Flow|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
10943090|NCT00772590|OG000|Outcome|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
10943091|NCT00772590|OG001|Outcome|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
10943092|NCT00772590|OG002|Outcome|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
10943093|NCT00772590|OG003|Outcome|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
10943094|NCT00772590|EG000|Reported Event|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
10943095|NCT00772590|EG001|Reported Event|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
10943096|NCT00772590|EG002|Reported Event|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
10943097|NCT00772590|EG003|Reported Event|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
10943098|NCT00772603|BG000|Baseline|2400mg/Day SPN-804|2400mg SPN-804O once daily
10943099|NCT00772603|BG001|Baseline|1200mg/Day SPN-804|1200mg SPN-804O given once daily
10943100|NCT00772603|BG002|Baseline|Placebo|Placebo given once daily.
10943101|NCT00772603|BG003|Baseline|Total|Total of all reporting groups
10943102|NCT00772603|FG000|Participant Flow|2400mg/Day SPN-804|2400mg of SPN-804O once daily
10943103|NCT00772603|FG001|Participant Flow|1200mg/Day SPN-804|1200mg SPN-804O once daily
10943104|NCT00772603|FG002|Participant Flow|Placebo|Placebo once daily
10943105|NCT00772603|OG000|Outcome|2400mg/Day SPN-804|2400mg SPN-804 once daily
10943106|NCT00772603|OG001|Outcome|1200mg/Day SPN-804|1200mg SPN-804 once daily
10943107|NCT00772603|OG002|Outcome|Placebo|Placebo once daily.
10943108|NCT00772603|OG000|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
10943109|NCT00772603|OG001|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
10943110|NCT00772603|OG002|Outcome|Placebo|Placebo given once daily.
10943111|NCT00772603|EG000|Reported Event|2400mg/Day SPN-804|2400mg total daily dose of SPN-804O once a day (QD), given as four 600mg tablets
10943112|NCT00772603|EG001|Reported Event|1200mg/Day SPN-804|1200mg total daily dose of SPN-804O QD, given as two 600mg tablets and two identical placebo tablets.
10943113|NCT00772603|EG002|Reported Event|Placebo|placebo QD, given as four placebo tablets
10943114|NCT00772629|BG000|Baseline|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
10963479|NCT00872339|BG003|Baseline|Total|Total of all reporting groups
10943115|NCT00772629|BG001|Baseline|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
10943116|NCT00772629|BG002|Baseline|Total|Total of all reporting groups
10943117|NCT00772629|FG000|Participant Flow|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
10943118|NCT00772629|FG001|Participant Flow|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
10943119|NCT00772629|OG000|Outcome|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
10943120|NCT00772629|OG001|Outcome|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
10943121|NCT00772629|EG000|Reported Event|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
10943122|NCT00772629|EG001|Reported Event|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
10943123|NCT00772668|BG000|Baseline|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles"
10943124|NCT00772668|FG000|Participant Flow|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles"
10943125|NCT00772668|OG000|Outcome|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles"
10943126|NCT00772668|OG000|Outcome|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab: Administered intravenously during induction and maintenance therapy per protocol.~Bortezomib: Administered intravenously per protocol.~Cyclophosphamide: Administered intravenously per protocol.~Prednisone: Administered orally (PO) per protocol."
10943127|NCT00772668|EG000|Reported Event|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles"
10943128|NCT00772707|BG000|Baseline|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
10943129|NCT00772707|FG000|Participant Flow|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
10943130|NCT00772707|OG000|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
11177374|NCT02040766|FG000|Participant Flow|Placebo BAI and MDI|"Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177375|NCT02040766|FG001|Participant Flow|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).~Placebo MDI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177376|NCT02040766|FG002|Participant Flow|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).~Placebo MDI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177377|NCT02040766|FG003|Participant Flow|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).~Placebo BAI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177378|NCT02040766|FG004|Participant Flow|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).~Placebo BAI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177379|NCT02040766|OG000|Outcome|Placebo BAI and MDI|"Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
10943131|NCT00772707|EG000|Reported Event|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
10943132|NCT00772772|BG000|Baseline|Vitamin D3|
10943133|NCT00772772|FG000|Participant Flow|Vitamin D3|Vitamin D3 30,000 units PO weekly for 8 weeks
10943134|NCT00772772|OG000|Outcome|Patients With Chronic Kidney Disease (CKD)|CKD patients who were Vitamin D deficient and received Vitamin D3 repletion
10943135|NCT00772772|OG000|Outcome|CKD Patients|
10943136|NCT00772772|EG000|Reported Event|Vitamin D3|
10943137|NCT00772889|BG000|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
10943138|NCT00772889|BG001|Baseline|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
10943139|NCT00772889|BG002|Baseline|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
10943140|NCT00772889|BG003|Baseline|Total|Total of all reporting groups
10943141|NCT00772889|FG000|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
10943142|NCT00772889|FG001|Participant Flow|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
10943143|NCT00772889|FG002|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
10943144|NCT00772889|OG000|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
10943145|NCT00772889|OG001|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
10943146|NCT00772889|OG002|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
10943147|NCT00772889|EG000|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
10943148|NCT00772889|EG001|Reported Event|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
10943149|NCT00772889|EG002|Reported Event|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
10943150|NCT00772915|BG000|Baseline|Lenalidomide With On-Demand Dexamethasone|"Lenalidomide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.~Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
10943151|NCT00772915|FG000|Participant Flow|Lenalidomide With On-Demand Dexamethasone|"Lenalidomide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.~Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
10943152|NCT00772915|OG000|Outcome|Lenalidomide With On-Demand Dexamethasone|"Lenalidomide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.~Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
10943153|NCT00772915|EG000|Reported Event|Lenalidomide With On-Demand Dexamethasone|Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
10943154|NCT00772928|BG000|Baseline|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
10943155|NCT00772928|BG001|Baseline|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
10943156|NCT00772928|BG002|Baseline|Total|Total of all reporting groups
10943157|NCT00772928|FG000|Participant Flow|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
10943158|NCT00772928|FG001|Participant Flow|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
10943159|NCT00772928|OG000|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
10943160|NCT00772928|OG001|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
10943161|NCT00772928|EG000|Reported Event|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
10943162|NCT00772928|EG001|Reported Event|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
10943163|NCT00772941|BG000|Baseline|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
10943164|NCT00772941|FG000|Participant Flow|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
10943165|NCT00772941|OG000|Outcome|Male|Male participants taking Varenicline according to Japanese Package Insert.
10943166|NCT00772941|OG001|Outcome|Female|Female participants taking Varenicline according to Japanese Package Insert.
10943167|NCT00772941|OG000|Outcome|<65 Years|Participants with <65 years taking Varenicline according to Japanese Package Insert.
10943168|NCT00772941|OG001|Outcome|>=65 Years|Participants with >=65 years taking Varenicline according to Japanese Package Insert.
10943169|NCT00772941|OG000|Outcome|Varenicline - With Chronic Obstructive Pulmonary Disease|Participants with chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
10943170|NCT00772941|OG001|Outcome|Varenicline - Without Chronic Obstructive Pulmonary Disease|Participants without chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
10943171|NCT00772941|OG000|Outcome|Varenicline - With Concomitant Drugs|Participants taking concomitant drugs while taking Varenicline according to Japanese Package Insert.
10943172|NCT00772941|OG001|Outcome|Varenicline - Without Concomitant Drugs|Participants taking no concomitant drugs while taking Varenicline according to Japanese Package Insert.
10943173|NCT00772941|OG000|Outcome|Varenicline - With Concomitant Therapies|Participants receiving concomitant therapies while taking Varenicline according to Japanese Package Insert.
10943174|NCT00772941|OG001|Outcome|Varenicline - Without Concomitant Therapies|Participants receiving no concomitant therapies while taking Varenicline according to Japanese Package Insert.
10943175|NCT00772941|OG000|Outcome|<40 kg at Baseline|Participants whose weights at baseline were less than 40 kg.
10943176|NCT00772941|OG001|Outcome|>=40 kg and <50 kg at Baseline|Participants whose weights at baseline were more than or equal to 40 kg and less than 50 kg.
10943177|NCT00772941|OG002|Outcome|>=50 kg and <60 kg at Baseline|Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.
10943178|NCT00772941|OG003|Outcome|>=60 kg and <70 kg at Baseline|Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.
10943179|NCT00772941|OG004|Outcome|>=70 kg and <80 kg at Baseline|Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.
10943180|NCT00772941|OG005|Outcome|>= 80 kg at Baseline|Participants whose weights at baseline were more than or equal to 80 kg.
10943181|NCT00772941|OG000|Outcome|<=20 Cigarettes Per Day|Participants with <=20 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
10943182|NCT00772941|OG001|Outcome|>=21 and <=40 Cigarettes Per Day|Participants with >=21 and <=40 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
10943183|NCT00772941|OG002|Outcome|>=41 Cigarettes Per Day|Participants with >=41 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
10943184|NCT00772941|OG000|Outcome|Administration Prolonged After 12 Weeks|Participants with prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
10943185|NCT00772941|OG001|Outcome|Administration Not Prolonged After 12 Weeks|Participants without prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
10943186|NCT00772941|OG000|Outcome|Varenicline - With Antipsychotics as a Concomitant Drug|Varenicline with Antipsychotics as a Concomitant Drug
10943187|NCT00772941|OG001|Outcome|Varenicline - Without Antipsychotics as a Concomitant Drug|Varenicline without Antipsychotics as a Concomitant Drug
10943188|NCT00772941|OG000|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
10943189|NCT00772941|EG000|Reported Event|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
10943190|NCT00772954|BG000|Baseline|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
10943191|NCT00772954|BG001|Baseline|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
10943192|NCT00772954|BG002|Baseline|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
10943193|NCT00772954|BG003|Baseline|Total|Total of all reporting groups
10943194|NCT00772954|FG000|Participant Flow|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
10943195|NCT00772954|FG001|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
10943196|NCT00772954|FG002|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
10943197|NCT00772954|OG000|Outcome|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
10943198|NCT00772954|OG001|Outcome|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
10943199|NCT00772954|OG002|Outcome|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
10943200|NCT00772954|EG000|Reported Event|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
10943201|NCT00772954|EG001|Reported Event|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
10943202|NCT00772954|EG002|Reported Event|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
10943203|NCT00772967|BG000|Baseline|All Participants|All randomized participants
10943204|NCT00772967|FG000|Participant Flow|Placebo, Naproxen, Ultracet|Placebo in Treatment Period 1, Naproxen in Treatment Period 2, Ultracet in Treatment Period 3.
10943205|NCT00772967|FG001|Participant Flow|Naproxen, Ultracet, Placebo|Naproxen in Treatment Period 1, Ultracet in Treatment Period 2, Placebo in Treatment Period 3.
10943206|NCT00772967|FG002|Participant Flow|Ultracet, Placebo, Naproxen|Ultracet in Treatment Period 1, Placebo in Treatment Period 2, Naproxen in Treatment Period 3.
10943207|NCT00772967|FG003|Participant Flow|Placebo, Ultracet, Naproxen|Placebo in Treatment Period 1, Ultracet in Treatment Period 2, Naproxen in Treatment Period 3.
10943208|NCT00772967|FG004|Participant Flow|Naproxen, Placebo, Ultracet|Naproxen in Treatment Period 1, Placebo in Treatment Period 2, Ultracet inTreatment Period 3.
10943209|NCT00772967|FG005|Participant Flow|Ultracet, Naproxen, Placebo|Ultracet in Treatment Period 1, Naproxen in Treatment Period 2, Placebo in Treatment Period 3.
10943210|NCT00772967|OG000|Outcome|Placebo|Participants treated with at least one dose of Placebo
10943211|NCT00772967|OG001|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
10943212|NCT00772967|OG002|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
10943213|NCT00772967|EG000|Reported Event|Placebo|Participants treated with at least one dose of Placebo
10943214|NCT00772967|EG001|Reported Event|Naproxen|Participants treated with at least one dose of Naproxen
10943215|NCT00772967|EG002|Reported Event|Ultracet|Participants treated with at least one dose of Ultracet. Two participants were not treated due to discontinuation.
10943216|NCT00773097|BG000|Baseline|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
10943217|NCT00773097|FG000|Participant Flow|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
10943218|NCT00773097|OG000|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
10943219|NCT00773097|EG000|Reported Event|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
10943220|NCT00773136|BG000|Baseline|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
10943221|NCT00773136|FG000|Participant Flow|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
10943222|NCT00773136|OG000|Outcome|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
10943223|NCT00773136|OG001|Outcome|Control Group|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
10943224|NCT00773136|EG000|Reported Event|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
10943225|NCT00773175|BG000|Baseline|Subcutaneous Hylenex|Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter [mL]).
10943226|NCT00773175|BG001|Baseline|Intravenous Isotonic Fluid|Participants received isotonic fluid rehydration by intravenous injection.
10943227|NCT00773175|BG002|Baseline|Total|Total of all reporting groups
10943228|NCT00773175|FG000|Participant Flow|Subcutaneous Hylenex|Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter [mL]).
10943229|NCT00773175|FG001|Participant Flow|Intravenous Isotonic Fluid|Participants received isotonic fluid rehydration by intravenous injection.
10943230|NCT00773175|OG000|Outcome|Subcutaneous Hylenex|Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter [mL]).
10943231|NCT00773175|OG001|Outcome|Intravenous Isotonic Fluid|Participants received isotonic fluid rehydration by intravenous (IV) injection.
10943232|NCT00773175|OG000|Outcome|Subcutaneous Hylenex|Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter [mL]).
10943233|NCT00773175|OG001|Outcome|Intravenous Isotonic Fluid: Non-rescued|Participants randomized to receive IV isotonic fluid who were not rescued via the hylenex-facilitated SC-rescue route, as IV access could be established.
10943234|NCT00773175|OG000|Outcome|Intravenous Isotonic Fluid: SC Rescued|Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
10943235|NCT00773175|OG001|Outcome|Intravenous Isotonic Fluid|Participants received isotonic fluid rehydration by intravenous injection.
10943236|NCT00773175|OG002|Outcome|Intravenous Isotonic Fluid: SC Rescued|Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
10943237|NCT00773175|EG000|Reported Event|Subcutaneous Hylenex|Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter [mL]).
10943238|NCT00773175|EG001|Reported Event|Intravenous Isotonic Fluid|Participants received isotonic fluid rehydration by intravenous injection.
10943239|NCT00773253|BG000|Baseline|Standard EMG Guided Injections Then Multi-channel|All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
10943240|NCT00773253|BG001|Baseline|Multi-channel EMG-guided Botox Injection Then Single Channel|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.
10943241|NCT00773253|BG002|Baseline|Total|Total of all reporting groups
10943242|NCT00773253|FG000|Participant Flow|Standard EMG Guided Injections Then Multi-channel Injections|All patients will undergo injection using conventional single channel (standard)EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
10943243|NCT00773253|FG001|Participant Flow|Multi-channel EMG-guided Botox Injection Then Standard EMG Inj|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design.
10943244|NCT00773253|OG000|Outcome|Standard EMG-guided Botox Injection|"All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.~Botulinum toxin A: All patients will be treated with Botox using both single-channel and multi-channel EMG mapping."
10943245|NCT00773253|OG001|Outcome|Multi-channel EMG-guided Botox Injection|"Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.~Botulinum toxin A: All patients will be treated with Botox using both single-channel and multi-channel EMG mapping."
10943246|NCT00773253|OG000|Outcome|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
10943247|NCT00773253|OG001|Outcome|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
10943248|NCT00773253|EG000|Reported Event|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
10943249|NCT00773253|EG001|Reported Event|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
10943250|NCT00773279|BG000|Baseline|Entire Trial Population|Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
10943251|NCT00773279|FG000|Participant Flow|PDS290 -> FlexPen®|
10943252|NCT00773279|FG001|Participant Flow|FlexPen® -> PDS290|
10943253|NCT00773279|OG000|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
10943254|NCT00773279|OG001|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
10943255|NCT00773279|OG000|Outcome|Entire Trial Population|Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
10943256|NCT00773279|EG000|Reported Event|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
10943257|NCT00773279|EG001|Reported Event|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
10943258|NCT00773292|BG000|Baseline|Ciclosporin|"48 weeks treatment with ciclosporin~ciclosporin: Ciclosporin 2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration"
10943259|NCT00773292|FG000|Participant Flow|Ciclosporin|"48 weeks treatment with ciclosporin~ciclosporin: Ciclosporin 2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration"
10943260|NCT00773292|OG000|Outcome|Ciclosporin|"48 weeks treatment with ciclosporin~ciclosporin: Ciclosporin 2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration"
10943261|NCT00773292|EG000|Reported Event|Ciclosporin|"48 weeks treatment with ciclosporin~ciclosporin: Ciclosporin 2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration"
10943262|NCT00773370|BG000|Baseline|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
10943263|NCT00773370|BG001|Baseline|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
10943264|NCT00773370|BG002|Baseline|Total|Total of all reporting groups
10943265|NCT00773370|FG000|Participant Flow|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
10943266|NCT00773370|FG001|Participant Flow|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
10943267|NCT00773370|OG000|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
10943268|NCT00773370|OG001|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
10943269|NCT00773370|EG000|Reported Event|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
10943270|NCT00773370|EG001|Reported Event|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
10943271|NCT00773383|BG000|Baseline|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
10943272|NCT00773383|FG000|Participant Flow|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
10943273|NCT00773383|OG000|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
11234313|NCT02433665|EG000|Reported Event|Fixed Dose|"100 of the first 200 subjects will be randomized to a fixed dose of contrast material.~Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine)."
10943274|NCT00773383|OG000|Outcome|R1507_Baseline Glucose Normal|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline < 110 mg/dL."
10943275|NCT00773383|OG001|Outcome|R1507_Baseline Impaired Fasting Glucose|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline ≥ 110 to < 126 mg/dL"
10943276|NCT00773383|OG002|Outcome|R1507_Baseline Diabetes Mellitus|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL"
10943277|NCT00773383|OG003|Outcome|R1507_Baseline Missing|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
10943278|NCT00773383|EG000|Reported Event|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
10943279|NCT00773422|BG000|Baseline|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
10943280|NCT00773422|BG001|Baseline|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
10943281|NCT00773422|BG002|Baseline|Placebo|"placebo control~placebo: placebo"
10943282|NCT00773422|BG003|Baseline|Total|Total of all reporting groups
10943283|NCT00773422|FG000|Participant Flow|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
10943284|NCT00773422|FG001|Participant Flow|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
10943285|NCT00773422|FG002|Participant Flow|Placebo|"placebo control~placebo: placebo"
10963480|NCT00872339|FG000|Participant Flow|Transfusion-dependant|People with transfusion-dependant thalassemia.
11341668|NCT03686176|FG000|Participant Flow|Virtual Reality Group (Study Group)|"In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure.~Virtual Reality (VR): A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins."
10943286|NCT00773422|OG000|Outcome|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
10943287|NCT00773422|OG001|Outcome|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
10943288|NCT00773422|OG002|Outcome|Placebo|"placebo control~placebo: placebo"
10943289|NCT00773422|EG000|Reported Event|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
10943290|NCT00773422|EG001|Reported Event|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
10943291|NCT00773422|EG002|Reported Event|Placebo|"placebo control~placebo: placebo"
10963481|NCT00872339|FG001|Participant Flow|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
10963482|NCT00872339|FG002|Participant Flow|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
10963483|NCT00872339|OG000|Outcome|Transfusion-dependant|People with transfusion-dependant thalassemia.
10963484|NCT00872339|OG001|Outcome|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
10963485|NCT00872339|OG002|Outcome|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
10963486|NCT00872339|OG000|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
10963487|NCT00872339|OG000|Outcome|All Subjects Combined|Subjects were combined into one group.
10963488|NCT00872339|EG000|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected for this study.
10963489|NCT00872521|BG000|Baseline|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963490|NCT00872521|BG001|Baseline|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963491|NCT00872521|BG002|Baseline|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963492|NCT00872521|BG003|Baseline|Total|Total of all reporting groups
10963493|NCT00872521|FG000|Participant Flow|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963494|NCT00872521|FG001|Participant Flow|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963495|NCT00872521|FG002|Participant Flow|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963496|NCT00872521|OG000|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963497|NCT00872521|OG001|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963498|NCT00872521|OG002|Outcome|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963499|NCT00872521|OG003|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963500|NCT00872521|OG002|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963501|NCT00872521|OG000|Outcome|Negative|Participants without p53 expression
10963502|NCT00872521|OG001|Outcome|Positive|Participants with p53 expression
10963503|NCT00872521|OG000|Outcome|Negative|Participants without Cyclin D1 expression
10963504|NCT00872521|OG001|Outcome|Positive|Participants with Cyclin D1 expression
10963505|NCT00872521|OG000|Outcome|Negative|Participants without bcl-2 expression
10963506|NCT00872521|OG001|Outcome|Positive|Participants with bcl-2 expression
10963507|NCT00872521|OG000|Outcome|Negative|Participants without FGFR3 expression
10963508|NCT00872521|OG001|Outcome|Positive|Participants with FGFR3 expression
11341669|NCT03686176|FG001|Participant Flow|Standard Care (Control Group)|In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.
10943292|NCT00773461|BG000|Baseline|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
10943293|NCT00773461|BG001|Baseline|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
10943294|NCT00773461|BG002|Baseline|Total|Total of all reporting groups
10943295|NCT00773461|FG000|Participant Flow|Placebo + DMARDs|Participants received placebo intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
10943296|NCT00773461|FG001|Participant Flow|Tocilizumab + DMARDs|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
10943297|NCT00773461|OG000|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
11177380|NCT02040766|OG001|Outcome|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).~Placebo MDI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177381|NCT02040766|OG002|Outcome|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).~Placebo MDI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177382|NCT02040766|OG003|Outcome|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).~Placebo BAI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
10943298|NCT00773461|OG001|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
10943299|NCT00773461|OG000|Outcome|Placebo+DMARD|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
10943300|NCT00773461|EG000|Reported Event|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
10943301|NCT00773461|EG001|Reported Event|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
10943302|NCT00773474|BG000|Baseline|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion."
10943303|NCT00773474|FG000|Participant Flow|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion."
10943304|NCT00773474|OG000|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion."
10943305|NCT00773474|EG000|Reported Event|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion."
10943306|NCT00773513|BG000|Baseline|Erythropoiesis Stimulating Agents|Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
10943307|NCT00773513|BG001|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
10943308|NCT00773513|BG002|Baseline|Total|Total of all reporting groups
11177383|NCT02040766|OG004|Outcome|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).~Placebo BAI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177384|NCT02040766|EG000|Reported Event|Run-in Placebo|"Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily. Both were single-blind therapies giving participants experience with the devices.~Prestudy asthma medications were adjusted according to the protocol.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177385|NCT02040766|EG001|Reported Event|Placebo BAI and MDI|"Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11341670|NCT03686176|FG002|Participant Flow|Reference Group|No virtual reality and no child life specialists; no standardized or formal form of support.
10943309|NCT00773513|FG000|Participant Flow|Erythropoiesis Stimulating Agents (ESA)|Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
10943310|NCT00773513|FG001|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
10943311|NCT00773513|OG000|Outcome|Erythropoiesis Stimulating Agents|Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
10943312|NCT00773513|OG001|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
10943313|NCT00773513|EG000|Reported Event|Erythropoiesis Stimulating Agents|Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
10943314|NCT00773513|EG001|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
10943315|NCT00773604|BG000|Baseline|Open Label Cohort|This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
10943316|NCT00773604|FG000|Participant Flow|Open Label Cohort|This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
10943317|NCT00773604|OG000|Outcome|Open Label Cohort|This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
10943318|NCT00773604|EG000|Reported Event|Treatment|DBS treatment patients
10943319|NCT00773734|BG000|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
10943320|NCT00773734|BG001|Baseline|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
10943321|NCT00773734|BG002|Baseline|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
10943322|NCT00773734|BG003|Baseline|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
10943323|NCT00773734|BG004|Baseline|Total|Total of all reporting groups
10943324|NCT00773734|FG000|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
10943325|NCT00773734|FG001|Participant Flow|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg by mouth (PO) BID during the Placebo-controlled Phase (Weeks 0-16).
10943326|NCT00773734|FG002|Participant Flow|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
10943327|NCT00773734|FG003|Participant Flow|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
10943328|NCT00773734|FG004|Participant Flow|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
10963509|NCT00872521|EG000|Reported Event|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963510|NCT00872521|EG001|Reported Event|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
11341671|NCT03686176|OG000|Outcome|Virtual Reality Group (Study Group)|"In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure.~Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins."
10943329|NCT00773734|FG005|Participant Flow|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
10943330|NCT00773734|OG000|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
10943331|NCT00773734|OG001|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
10943332|NCT00773734|OG002|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
10943333|NCT00773734|OG003|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
10943334|NCT00773734|OG000|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 10 mg BID PO during the Active Treatment Phase (Weeks 16-24).
10943335|NCT00773734|OG001|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
10943336|NCT00773734|OG002|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
10943337|NCT00773734|OG003|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg PO BID during the active treatment phase (Weeks 16-24).
10943338|NCT00773734|OG004|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
10943339|NCT00773734|OG000|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16).
10943340|NCT00773734|OG000|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
11177386|NCT02040766|EG002|Reported Event|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).~Placebo MDI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177387|NCT02040766|EG003|Reported Event|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).~Placebo MDI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
10943341|NCT00773734|OG001|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
10943342|NCT00773734|OG003|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
10943343|NCT00773734|OG004|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
10943344|NCT00773734|OG000|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
10943345|NCT00773734|OG002|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
10943346|NCT00773734|OG003|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
10943347|NCT00773734|OG004|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
10943348|NCT00773734|OG000|Outcome|Apremilast 10mg BID|Participants who were initially randomized to APR 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
10943349|NCT00773734|OG003|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg tablets BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
10943350|NCT00773734|OG004|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
10943351|NCT00773734|OG000|Outcome|Placebo BID|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
10943352|NCT00773734|OG000|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16). .
10943353|NCT00773734|OG003|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
10943354|NCT00773734|OG004|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
10943355|NCT00773734|OG000|Outcome|Placebo|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
10943356|NCT00773734|OG001|Outcome|Apremilast 10mg|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
10943357|NCT00773734|OG002|Outcome|Apremilast 20mg|Participants were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
10943358|NCT00773734|OG003|Outcome|Apremilast 30 mg|Participants were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
10943359|NCT00773734|OG003|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
10943360|NCT00773734|OG001|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16).
10943361|NCT00773734|OG003|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
10943362|NCT00773734|OG003|Outcome|Placebo-Apremilast (APR) 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
10943363|NCT00773734|OG003|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
10943364|NCT00773734|OG004|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
10943365|NCT00773734|OG000|Outcome|Apremilast 10mg BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
10943366|NCT00773734|OG000|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
10943367|NCT00773734|OG000|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
10943368|NCT00773734|OG000|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
10943369|NCT00773734|OG000|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
10943370|NCT00773734|OG000|Outcome|Placebo BID|Participants were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16)
10943371|NCT00773734|OG000|Outcome|Placebo BID|.Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
10943372|NCT00773734|OG001|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
10943373|NCT00773734|OG003|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
10943374|NCT00773734|OG004|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
10943375|NCT00773734|OG001|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
10943376|NCT00773734|OG003|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
10943377|NCT00773734|OG001|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
10943378|NCT00773734|EG000|Reported Event|Placebo (Weeks 0-16)|Participants randomized to placebo PO BID during the Placebo-controlled Phase
10943379|NCT00773734|EG001|Reported Event|Apremilast 10mg BID (Weeks 0-16)|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
10943380|NCT00773734|EG002|Reported Event|Apremilast 20mg BID (Weeks 0-16)|Participants randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
10943381|NCT00773734|EG003|Reported Event|Apremilast 30mg BID (Weeks 0-16)|Participants randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
10943382|NCT00773734|EG004|Reported Event|Apremilast 10mg BID (APR Exposure Period) Years 0-6|Participants initially randomized to 10 mg PO BID apremilast at Week 0. Participants who were dosed with apremilast 10mg BID in the extension study were randomly assigned to either apremilast 20 mg or 30 mg BID in the long term extension study (LTE).
10943383|NCT00773734|EG005|Reported Event|Apremilast 20mg BID (APR Exposure Period) Years 0-6|Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
10943384|NCT00773734|EG006|Reported Event|Apremilast 30mg BID (APR Exposure Period) Years 0-6|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
10943385|NCT00773747|BG000|Baseline|Vorinostat + Bortezomib|Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
10943386|NCT00773747|BG001|Baseline|Placebo + Bortezomib|Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
10943387|NCT00773747|BG002|Baseline|Total|Total of all reporting groups
10943388|NCT00773747|FG000|Participant Flow|Vorinostat + Bortezomib|Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
10943389|NCT00773747|FG001|Participant Flow|Placebo + Bortezomib|Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
10943390|NCT00773747|OG000|Outcome|Vorinostat + Bortezomib|Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
10943391|NCT00773747|OG001|Outcome|Placebo + Bortezomib|Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
10943392|NCT00773747|EG000|Reported Event|Vorinostat + Bortezomib|Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
10943393|NCT00773747|EG001|Reported Event|Placebo + Bortezomib|Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
10943394|NCT00773786|BG000|Baseline|All Study Participants|Participants randomized and received either Tiotropium + Brovana twice daily for 1 week or Tiotropium + placebo twice daily for 1 week.
10943395|NCT00773786|FG000|Participant Flow|Tiotropium + Arformoterol (Brovana), Then Tiotropium + Placebo|Participants first received Tiotropium + Brovana twice daily for 1 week via nebulizer. After a 1 week washout period, they received Tiotropium + placebo twice daily for 1 week.
10943396|NCT00773786|FG001|Participant Flow|Placebo, Then Arformoterol (Brovana)|Participants first received Tiotropium + Placebo twice daily for 1 week . After a 1 week washout period, they received Tiotropium + Brovana twice daily for 1 week via nebulizer.
10943397|NCT00773786|OG000|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
10943398|NCT00773786|OG001|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
10943399|NCT00773786|OG001|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week
10943400|NCT00773786|EG000|Reported Event|Arformoterol|Arformoterol twice daily for 1 week via nebulizer
10943401|NCT00773786|EG001|Reported Event|Placebo|Placebo twice daily for 1 week
10963511|NCT00872521|EG002|Reported Event|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10963512|NCT00872521|EG003|Reported Event|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
10943402|NCT00773838|BG000|Baseline|Vorinostat + Bortezomib|Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
10943403|NCT00773838|FG000|Participant Flow|Vorinostat + Bortezomib|Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
10943404|NCT00773838|OG000|Outcome|Vorinostat + Bortezomib|Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
10943405|NCT00773838|EG000|Reported Event|Vorinostat + Bortezomib|Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
10943406|NCT00773955|BG000|Baseline|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10943407|NCT00773955|FG000|Participant Flow|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10943408|NCT00773955|OG000|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10943409|NCT00773955|EG000|Reported Event|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10943410|NCT00773968|BG000|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
10943411|NCT00773968|FG000|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator [CERA]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (<) 40 µg or 40-80 µg or greater than (>) 80 µg, respectively. The doses were adjusted according to individual participant's hemoglobin (Hb) value.
10943412|NCT00773968|OG000|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
11177388|NCT02040766|EG004|Reported Event|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).~Placebo BAI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177389|NCT02040766|EG005|Reported Event|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).~Placebo BAI twice daily for blinding.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study."
11177390|NCT02040779|BG000|Baseline|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
10943413|NCT00773968|EG000|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
10943414|NCT00774046|BG000|Baseline|All Patients|Ara-C Mitoxantrone Etoposide
10943415|NCT00774046|FG000|Participant Flow|Induction Chemotherapy Followed by Stem Cell Transplant|Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
10943416|NCT00774046|OG000|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
10943417|NCT00774046|EG000|Reported Event|All Patients|Ara-C Mitoxantrone Etoposide
10943418|NCT00774163|BG000|Baseline|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
11177391|NCT02040779|BG001|Baseline|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
11177392|NCT02040779|BG002|Baseline|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
10943419|NCT00774163|BG001|Baseline|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
10943420|NCT00774163|BG002|Baseline|Total|Total of all reporting groups
10943421|NCT00774163|FG000|Participant Flow|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
10943422|NCT00774163|FG001|Participant Flow|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
10943423|NCT00774163|OG000|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
10943424|NCT00774163|OG001|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
10943425|NCT00774163|EG000|Reported Event|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
10943426|NCT00774163|EG001|Reported Event|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
10943427|NCT00774202|BG000|Baseline|Standard Dose of Rituxan Plus CVP (R-CVP)|'Rituxan + Cyclophosphamide, Vincristine and Prednisone (R-CVP). Rituximab administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. First Rituxan infusion will be given 5 days (± 3 days) prior to the first CVP, and the following 3 infusions will be given on the same day as the 3 cycles of CVP at week 2, week 5, and week 8.
11177393|NCT02040779|BG003|Baseline|Total|Total of all reporting groups
10943428|NCT00774202|BG001|Baseline|Double Dose of Rituximab|Rituximab administered at a dose of 750 mg/m2 once a week x 4 consecutive weeks (4 infusions in total).
10943429|NCT00774202|BG002|Baseline|Total|Total of all reporting groups
10943430|NCT00774202|FG000|Participant Flow|Standard Dose of Rituxan Plus CVP (R-CVP)|'Rituxan + Cyclophosphamide, Vincristine and Prednisone (R-CVP). Rituximab administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. First Rituxan infusion will be given 5 days (± 3 days) prior to the first CVP, and the following 3 infusions will be given on the same day as the 3 cycles of CVP at week 2, week 5, and week 8.
10943431|NCT00774202|FG001|Participant Flow|Double Dose of Rituximab|Rituximab administered at a dose of 750 mg/m2 once a week x 4 consecutive weeks (4 infusions in total).
10943432|NCT00774202|OG000|Outcome|Standard Dose of Rituxan Plus CVP (R-CVP)|'Rituxan + Cyclophosphamide, Vincristine and Prednisone (R-CVP). Rituximab administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. First Rituxan infusion will be given 5 days (± 3 days) prior to the first CVP, and the following 3 infusions will be given on the same day as the 3 cycles of CVP at week 2, week 5, and week 8.
10943433|NCT00774202|OG001|Outcome|Double Dose of Rituximab|Rituximab administered at a dose of 750 mg/m2 once a week x 4 consecutive weeks (4 infusions in total).
11177394|NCT02040779|FG000|Participant Flow|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
11177395|NCT02040779|FG001|Participant Flow|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
11177396|NCT02040779|FG002|Participant Flow|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
11177397|NCT02040779|OG000|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
11177398|NCT02040779|OG001|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
10943434|NCT00774202|OG000|Outcome|Rituximab + CVP|patients receiving rituximab and cyclophosphamide and vincristine and prednisone
10943435|NCT00774202|OG001|Outcome|Double Dose Rituximab|:patients receiving double dose rituximab
10943436|NCT00774202|OG000|Outcome|Rituximab, C, V, P|rituximab, cyclophosphamide, vincristine, prednisone
10943437|NCT00774202|OG001|Outcome|High Dose Rituximab|double the dose of rituximab
10943438|NCT00774202|EG000|Reported Event|Rituximab + C, V, P|
10943439|NCT00774202|EG001|Reported Event|Double Dose Rituximab|
10943440|NCT00774267|BG000|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943441|NCT00774267|BG001|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943442|NCT00774267|BG002|Baseline|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943443|NCT00774267|BG003|Baseline|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943444|NCT00774267|BG004|Baseline|Total|Total of all reporting groups
10943445|NCT00774267|FG000|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10963513|NCT00872534|BG000|Baseline|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
10943446|NCT00774267|FG001|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943447|NCT00774267|FG002|Participant Flow|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943448|NCT00774267|FG003|Participant Flow|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943449|NCT00774267|OG000|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943450|NCT00774267|OG001|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943451|NCT00774267|OG002|Outcome|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943452|NCT00774267|OG003|Outcome|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943453|NCT00774267|EG000|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943454|NCT00774267|EG001|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943455|NCT00774267|EG002|Reported Event|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943456|NCT00774267|EG003|Reported Event|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
10943457|NCT00774397|BG000|Baseline|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943458|NCT00774397|BG001|Baseline|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943459|NCT00774397|BG002|Baseline|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943460|NCT00774397|BG003|Baseline|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943461|NCT00774397|BG004|Baseline|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943462|NCT00774397|BG005|Baseline|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943463|NCT00774397|BG006|Baseline|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943464|NCT00774397|BG007|Baseline|Total|Total of all reporting groups
10943465|NCT00774397|FG000|Participant Flow|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10963514|NCT00872534|BG001|Baseline|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
11177399|NCT02040779|OG002|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
11177400|NCT02040779|EG000|Reported Event|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
11177401|NCT02040779|EG001|Reported Event|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
11177402|NCT02040779|EG002|Reported Event|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
11177403|NCT02040805|BG000|Baseline|Group Cognitive-Behavioral Therapy|"Sixteen sessions of group therapy facilitated by a psychologist.~Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing clutter buddies, and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF."
10943466|NCT00774397|FG001|Participant Flow|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943467|NCT00774397|FG002|Participant Flow|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943468|NCT00774397|FG003|Participant Flow|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943469|NCT00774397|FG004|Participant Flow|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
11177404|NCT02040805|BG001|Baseline|Peer Facilitated Support Group|"Fifteen sessions of peer-facilitated group support.~Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual."
11177405|NCT02040805|BG002|Baseline|Total|Total of all reporting groups
11177406|NCT02040805|FG000|Participant Flow|Group Cognitive-Behavioral Therapy|"Sixteen sessions of group therapy facilitated by a psychologist.~Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing clutter buddies, and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF."
11177407|NCT02040805|FG001|Participant Flow|Peer Facilitated Support Group|"Fifteen sessions of peer-facilitated group support.~Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual."
11240721|NCT02481375|FG000|Participant Flow|Multiple Micronutrients With Iron|"Multiple micronutrient formulations were based on the UNICEF/WHO/UNU standard formulation for pregnant and lactating women (UNIMMAP) with increased iron (from 30 mg to 60 mg elemental iron) for comparability to the iron only group (60 mg). This formulation has 15 micronutrients including iron.~Women will receive the multiple micronutrient with iron for 12 weeks.~Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine~Iron: 12-wk supplementation of iron"
10943470|NCT00774397|FG005|Participant Flow|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943471|NCT00774397|FG006|Participant Flow|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943472|NCT00774397|OG000|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943473|NCT00774397|OG001|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10963515|NCT00872534|BG002|Baseline|Total|Total of all reporting groups
10943474|NCT00774397|OG002|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943475|NCT00774397|OG003|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943476|NCT00774397|OG004|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943477|NCT00774397|OG005|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943478|NCT00774397|OG006|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943479|NCT00774397|OG000|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943480|NCT00774397|OG000|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943481|NCT00774397|OG001|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943482|NCT00774397|OG002|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943483|NCT00774397|OG003|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
11240722|NCT02481375|FG001|Participant Flow|Multiple Micronutrients Without Iron|"This formulation has the 14 micronutrients included in the UNIMMAP formulation, but does not include iron.~Women will receive the multiple micronutrient without iron for 12 weeks.~Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine"
10943484|NCT00774397|OG004|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943485|NCT00774397|OG005|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943486|NCT00774397|EG000|Reported Event|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943487|NCT00774397|EG001|Reported Event|120mg QD/LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943488|NCT00774397|EG002|Reported Event|240mg QD/LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943489|NCT00774397|EG003|Reported Event|240mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943490|NCT00774397|EG004|Reported Event|240mg QD/LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943491|NCT00774397|EG005|Reported Event|240mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10963516|NCT00872534|FG000|Participant Flow|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
10963517|NCT00872534|FG001|Participant Flow|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
10943492|NCT00774397|EG006|Reported Event|240mg BID/LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
10943493|NCT00774566|BG000|Baseline|RF Ablation|Patients that have been randomized into the RF ablation group and have recieved the treatment as per protocol
10943494|NCT00774566|BG001|Baseline|CB Ablation|Patients that have been randomized into the cryo balloon ablation group and have recieved the treatment as per protocol
10943495|NCT00774566|BG002|Baseline|Total|Total of all reporting groups
10943496|NCT00774566|FG000|Participant Flow|Radiofrequency (RF) Ablation|Patients in this arm were treated with the established RF ablation approach with an open irrigated tip ablation catheter for the treatment of paroxysmal atrial fibrillation. All patients have at least experienced 2 episodes of AF within the last 3 month before inclusion.
10943497|NCT00774566|FG001|Participant Flow|Cryo Balloon(CB) Ablation|Patients in this arm were treated with the cryo balloon ablation technique for the tretment of paoxysmal atrial fibrillation (AF). All patients have at least experienced 2 episodes of AF within the last 3 month before inclusion.
10943498|NCT00774566|OG000|Outcome|RF Ablation|patients that have undergone RF ablation
10943499|NCT00774566|OG001|Outcome|CB Ablation|patients that have undergone CB ablation
10943500|NCT00774566|EG000|Reported Event|RF Ablation|all patients that underwent RF ablation procedure
10943501|NCT00774566|EG001|Reported Event|CB Ablation|all patients that underwent CB ablation procedure
10943502|NCT00774579|BG000|Baseline|GH Replacement|Patients with growth hormone (GH) deficiency starting GH replacement.
10943503|NCT00774579|BG001|Baseline|Control|Patients with growth hormone (GH) deficiency not starting GH replacement.
10943504|NCT00774579|BG002|Baseline|Total|Total of all reporting groups
10943505|NCT00774579|FG000|Participant Flow|GH Replacement|Patients with growth hormone (GH) deficiency starting GH replacement.
10943506|NCT00774579|FG001|Participant Flow|Control|Patients with growth hormone (GH) deficiency not starting GH replacement.
10943507|NCT00774579|OG000|Outcome|GH Replacement|Patients with growth hormone (GH) deficiency starting GH replacement.
10943508|NCT00774579|OG001|Outcome|Control|Patients with growth hormone (GH) deficiency not starting GH replacement.
10943509|NCT00774579|EG000|Reported Event|GH Replacement|Patients with growth hormone (GH) deficiency starting GH replacement.
10943510|NCT00774579|EG001|Reported Event|Control|Patients with growth hormone (GH) deficiency not starting GH replacement.
10943511|NCT00774748|BG000|Baseline|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
10943512|NCT00774748|FG000|Participant Flow|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
10943513|NCT00774748|OG000|Outcome|All Participants|Both dosing schedules, once and twice daily, all participants.
10943514|NCT00774748|OG000|Outcome|All Participants|All participants on both dosing schedules, once and twice daily LMWH.
10943515|NCT00774748|OG000|Outcome|All Participants|All participants on both dosing schedules, once and twice daily.
10943516|NCT00774748|OG000|Outcome|Once Daily Dosing|10 participants were placed on an once daily dosing schedule in accordance with their physician approved, standard of care weight specific dosage.
10943517|NCT00774748|OG000|Outcome|All Participants|All participants on both a daily and twice daily dosing schedule
10943518|NCT00774748|EG000|Reported Event|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
10943519|NCT00774787|BG000|Baseline|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
10943520|NCT00774787|FG000|Participant Flow|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
10943521|NCT00774787|OG000|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
10943522|NCT00774787|EG000|Reported Event|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
10943523|NCT00774800|BG000|Baseline|Overall Study|"Humalog+recombinant human hyaluronidase PH20 (rHuPH20): Up to 3 dose-finding (DF) visits (each visit separated by 3-10 days [d]) until an appropriate dose of Humalog was identified. For each DF visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously (SC) per unit of Humalog, corresponding to a mass concentration (conc) of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final conc of 91 U/mL of Humalog)~Humalog alone: After a 3-10 d washout (wo), a single SC injection of the appropriate identified dose of Humalog was delivered~Humulin-R+rHuPH20: After a 3-10 d wo, up to 2 DF visits (both visits separated by 3-10 d) until an appropriate dose of Humulin-R was identified. For each DF visit, a total of 24 U of rHuPH20 was injected SC per unit of Humulin-R, corresponding to a mass conc of 20.0 μg/mL rHuPH20 (at final conc of 100 U/mL of Humulin-R)~Humulin-R alone: After a 3-10 d wo, a single SC injection of the appropriate identified dose of Humulin-R was delivered"
10963518|NCT00872534|OG000|Outcome|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
10963519|NCT00872534|OG001|Outcome|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
10943524|NCT00774800|FG000|Participant Flow|First Humalog+PH20, Then Humalog, Humulin-R+PH20, Humulin-R|"Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.~Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, delivered before a liquid meal.~Humulin-R + rHuPH20 (Intervention 3): 24 U of rHuPH20 per unit of Humulin-R, injected SC, for up to 2 visits until an appropriate dose was identified.~Humulin-R alone (Intervention 4): a single SC injection of the appropriate identified dose of Humulin-R, delivered before a liquid meal.~Appropriate dose of either Humalog or Humulin-R was that at which blood glucose following a liquid meal was <160 milligrams per deciliter (mg/dL) for more than 30 minutes during the first 4 hours after injection and never fell below 60 mg/dL.~All dose finding visits and interventions were separated by 3-10 days."
10943525|NCT00774800|OG000|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
10943526|NCT00774800|OG001|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
10943527|NCT00774800|OG002|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
10943528|NCT00774800|OG003|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
10943529|NCT00774800|EG000|Reported Event|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
10943530|NCT00774800|EG001|Reported Event|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
10943531|NCT00774800|EG002|Reported Event|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
10943532|NCT00774800|EG003|Reported Event|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
10943533|NCT00774852|BG000|Baseline|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
10943534|NCT00774852|BG001|Baseline|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
10943535|NCT00774852|BG002|Baseline|Total|Total of all reporting groups
11177408|NCT02040805|OG000|Outcome|Group Cognitive-Behavioral Therapy|"Sixteen sessions of group therapy facilitated by a psychologist.~Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing clutter buddies, and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF."
11177409|NCT02040805|OG001|Outcome|Peer Facilitated Support Group|"Fifteen sessions of peer-facilitated group support.~Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual."
10943536|NCT00774852|FG000|Participant Flow|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
10943537|NCT00774852|FG001|Participant Flow|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
10943538|NCT00774852|OG000|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
10943539|NCT00774852|OG001|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
10943540|NCT00774852|OG000|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
10943541|NCT00774852|OG001|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
10943542|NCT00774852|OG002|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
10943543|NCT00774852|OG003|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
10943544|NCT00774852|OG000|Outcome|Week 24 Non-Responder: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
11177410|NCT02040805|EG000|Reported Event|Group Cognitive-Behavioral Therapy|"Sixteen sessions of group therapy facilitated by a psychologist.~Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing clutter buddies, and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF."
10943545|NCT00774852|OG001|Outcome|Week 24 Non-Responder: Placebo|Participants who were in the placebo arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
10943546|NCT00774852|OG000|Outcome|Week 24 Non-Responder Who Continued Treatment: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
11177411|NCT02040805|EG001|Reported Event|Peer Facilitated Support Group|"Fifteen sessions of peer-facilitated group support.~Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual."
11177412|NCT02040844|BG000|Baseline|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
10943547|NCT00774852|OG001|Outcome|Week 24 Non-Responder Who Continued Treatment: Placebo|Participants who were in the placebo arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
10943548|NCT00774852|OG004|Outcome|Week 24 No Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
10943549|NCT00774852|OG005|Outcome|Week 24 No Response: Placebo|At Week 28 participants assigned to Placebo group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
10943550|NCT00774852|EG000|Reported Event|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
10943551|NCT00774852|EG001|Reported Event|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
10943552|NCT00774930|BG000|Baseline|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
10943553|NCT00774930|BG001|Baseline|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
10943554|NCT00774930|BG002|Baseline|Total|Total of all reporting groups
10943555|NCT00774930|FG000|Participant Flow|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.
10943556|NCT00774930|FG001|Participant Flow|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
10943557|NCT00774930|OG000|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
10943558|NCT00774930|OG001|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
10943559|NCT00774930|EG000|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
10943560|NCT00774930|EG001|Reported Event|Placebo (DB Phase)|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
10943561|NCT00774930|EG002|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)|All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
10943562|NCT00774930|EG003|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)|All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
10943563|NCT00774995|BG000|Baseline|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943564|NCT00774995|BG001|Baseline|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943565|NCT00774995|BG002|Baseline|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
11177413|NCT02040844|BG001|Baseline|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
10943566|NCT00774995|BG003|Baseline|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943567|NCT00774995|BG004|Baseline|Total|Total of all reporting groups
10943568|NCT00774995|FG000|Participant Flow|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943569|NCT00774995|FG001|Participant Flow|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943570|NCT00774995|FG002|Participant Flow|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943571|NCT00774995|FG003|Participant Flow|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943572|NCT00774995|OG000|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943573|NCT00774995|OG001|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
11177414|NCT02040844|BG002|Baseline|Placebo|Placebo - 1 dose every 4 weeks
11177415|NCT02040844|BG003|Baseline|Total|Total of all reporting groups
10943574|NCT00774995|OG002|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943575|NCT00774995|OG003|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943576|NCT00774995|EG000|Reported Event|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943577|NCT00774995|EG001|Reported Event|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943578|NCT00774995|EG002|Reported Event|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943579|NCT00774995|EG003|Reported Event|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
10943580|NCT00775021|BG000|Baseline|Total Participants|Total number of participants that completed the study.
10943581|NCT00775021|FG000|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A contact lens worn first and nelfilcon A contact lens worn second
10943582|NCT00775021|FG001|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A contact lens worn first and etafilcon A contact lens second.
10943583|NCT00775021|OG000|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
10943584|NCT00775021|OG001|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
10943585|NCT00775021|EG000|Reported Event|Etafilcon A|etafilcon A contact lenses
10943586|NCT00775021|EG001|Reported Event|Nelfilcon A|nelfilcon A contact lenses.
10943587|NCT00775138|BG000|Baseline|Arikayce™ at 280 mg|Study subjects will receive Arikayce™ 280 mg on Days 1-28.
10943588|NCT00775138|BG001|Baseline|Matching Placebo (280 mg)|Study subjects will receive matching placebo on Days 1-28.
10943589|NCT00775138|BG002|Baseline|Arikayce™ at 560 mg|Study subjects will receive Arikayce™ 560 mg on Days 1-28.
10943590|NCT00775138|BG003|Baseline|Matching Placebo (560 mg)|Study subjects will receive matching placebo on Days 1-28.
10943591|NCT00775138|BG004|Baseline|Total|Total of all reporting groups
10943592|NCT00775138|FG000|Participant Flow|Arikayce™ at 280 mg|Study subjects will receive Arikayce™ 280 mg on Days 1-28.
10943593|NCT00775138|FG001|Participant Flow|Matching Placebo (280 mg)|Study subjects will receive matching placebo on Days 1-28.
10943594|NCT00775138|FG002|Participant Flow|Arikayce™ at 560 mg|Study subjects will receive Arikayce™ 560 mg on Days 1-28.
10943595|NCT00775138|FG003|Participant Flow|Matching Placebo (560 mg)|Study subjects will receive matching placebo on Days 1-28.
10943596|NCT00775138|OG000|Outcome|Arikace™ 280 mg|Study subjects will receive Arikace™ 280 mg on Days 1-28.
10943597|NCT00775138|OG001|Outcome|Matching Placebo (280 mg)|Study subjects will receive matching placebo on Days 1-28.
10943598|NCT00775138|OG002|Outcome|Arikace™ 560 mg|Study subjects will receive Arikace™ 560 mg on Days 1-28.
10943599|NCT00775138|OG003|Outcome|Matching Placebo (560 mg)|Study subjects will receive matching placebo on Days 1-28.
10943600|NCT00775138|OG002|Outcome|Arikace™ 560 mg|Study subjects will receive Arikace™ 280 mg on Days 1-28.
10943601|NCT00775138|OG001|Outcome|Matching Placebo (280mg)|Study subjects will receive matching placebo on Days 1-28.
10943602|NCT00775138|EG000|Reported Event|Arikace at 280 mg|Study subjects will receive Arikace™ 280 mg on Days 1-28.
11177416|NCT02040844|FG000|Participant Flow|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
11177417|NCT02040844|FG001|Participant Flow|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
11177418|NCT02040844|FG002|Participant Flow|Placebo|Placebo - 1 dose every 4 weeks
10943603|NCT00775138|EG001|Reported Event|Matching Placebo (280 mg)|Study subjects will receive matching placebo on Days 1-28.
10943604|NCT00775138|EG002|Reported Event|Arikace at 560 mg|Study subjects will receive Arikace™ 560 mg on Days 1-28.
10943605|NCT00775138|EG003|Reported Event|Matching Placebo (560 mg)|Study subjects will receive matching placebo on Days 1-28.
10943606|NCT00775203|BG000|Baseline|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
10943607|NCT00775203|BG001|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
10943608|NCT00775203|BG002|Baseline|Total|Total of all reporting groups
10943609|NCT00775203|FG000|Participant Flow|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
10943610|NCT00775203|FG001|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
10943611|NCT00775203|OG000|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
10943612|NCT00775203|OG001|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
10943613|NCT00775203|EG000|Reported Event|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
10943614|NCT00775203|EG001|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
10943615|NCT00775229|BG000|Baseline|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
10943616|NCT00775229|BG001|Baseline|Placebo|"Placebo~Placebo : pill, by mouth, daily"
10943617|NCT00775229|BG002|Baseline|Total|Total of all reporting groups
10943618|NCT00775229|FG000|Participant Flow|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
10943619|NCT00775229|FG001|Participant Flow|Placebo|"Placebo~Placebo : pill, by mouth, daily"
10943620|NCT00775229|OG000|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
10943621|NCT00775229|OG001|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
10943622|NCT00775229|EG000|Reported Event|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
10943623|NCT00775229|EG001|Reported Event|Placebo|"Placebo~Placebo : pill, by mouth, daily"
10943624|NCT00775268|BG000|Baseline|Participants Scanned at Baseline & After Chemotherapy|"Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.~Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans"
10943625|NCT00775268|BG001|Baseline|Participants Scanned in the Evaluation of Residual Masses After Therapy|"Patients undergo a 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.~Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"
10943626|NCT00775268|BG002|Baseline|Total|Total of all reporting groups
10943627|NCT00775268|FG000|Participant Flow|Participants Scanned at Baseline & After Chemotherapy|"Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.~Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans"
10943628|NCT00775268|FG001|Participant Flow|Participants Scanned in the Evaluation of Residual Masses After Therapy|"Patients undergo a 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.~Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"
10963520|NCT00872534|EG000|Reported Event|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
10943629|NCT00775268|OG000|Outcome|Participants Scanned in the Evaluation of Residual Masses After Therapy|"Patients undergo a 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.~Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"
10943630|NCT00775268|OG000|Outcome|Participants Scanned at Baseline & After Chemotherapy|"Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.~Fluordeoxyglucose F 18: Undergo scans~[3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans~computed tomography: Undergo scans"
10943631|NCT00775268|OG000|Outcome|Participants Scanned at Baseline & After Chemotherapy|Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans
10943632|NCT00775268|OG000|Outcome|Participants Scanned at Baseline|Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans
10943633|NCT00775268|OG001|Outcome|Participants Scanned After Completion of Therapy|Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans
10943634|NCT00775268|OG000|Outcome|Participants Scanned in the Evaluation of Residual Masses After Therapy|"Patients undergo a 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.~Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"
10943635|NCT00775268|OG000|Outcome|Participants Scanned in the Evaluation of Residual Masses After Therapy at 1 Hour Post Injection|Participants with residual masses after therapy were evaluated with FLT-positron-emission tomography (PET)/computed tomography (CT), acquiring the images after 1 hour after the intravenous injection of FLT to evaluate the tumor uptake value at 1 hour post injection.
10943636|NCT00775268|OG001|Outcome|Participants Scanned in the Evaluation of Residual Masses After Therapy at 2 Hours Post Injection|Participants with residual masses after therapy were evaluated with FLT-positron-emission tomography (PET)/computed tomography (CT), acquiring the images after 2 hours of the intravenous injection of FLT to evaluate the tumor uptake at at 2 hours post injection.
10943637|NCT00775268|OG000|Outcome|Participants Scanned at Baseline, at 2 Cycles & After ChemotherapyChemotherapy|Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans
10943638|NCT00775268|OG000|Outcome|Participants Scanned After Chemotherapy|"Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.~Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans"
10943639|NCT00775268|OG000|Outcome|Participants Scanned in the Evaluation of Residual Masses After Therapy|"Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.~Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"
10943640|NCT00775268|OG000|Outcome|Participants Scanned at Baseline & After Chemotherapy|"Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.~Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans"
10943641|NCT00775268|OG001|Outcome|Participants Scanned in the Evaluation of Residual Masses After Therapy|"Patients undergo a 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.~Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"
10943642|NCT00775268|EG000|Reported Event|Participants Scanned at Baseline & After Chemotherapy|"Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.~Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans"
10943643|NCT00775268|EG001|Reported Event|Participants Scanned in the Evaluation of Residual Masses After Therapy|"Patients undergo a 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.~Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected~fine-needle aspiration: sample collected"
10943644|NCT00775346|BG000|Baseline|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
10943645|NCT00775346|FG000|Participant Flow|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
10943646|NCT00775346|OG000|Outcome|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
10943647|NCT00775346|EG000|Reported Event|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
10943648|NCT00775411|BG000|Baseline|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
10943649|NCT00775411|FG000|Participant Flow|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
10943650|NCT00775411|OG000|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
10943651|NCT00775411|EG000|Reported Event|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
10943652|NCT00775437|BG000|Baseline|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
10943653|NCT00775437|FG000|Participant Flow|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
10943654|NCT00775437|OG000|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
10943655|NCT00775437|EG000|Reported Event|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
10943656|NCT00775450|BG000|Baseline|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
10943657|NCT00775450|BG001|Baseline|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
10943658|NCT00775450|BG002|Baseline|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
10943659|NCT00775450|BG003|Baseline|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
10943660|NCT00775450|BG004|Baseline|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
10943661|NCT00775450|BG005|Baseline|Total|Total of all reporting groups
10943662|NCT00775450|FG000|Participant Flow|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
10943663|NCT00775450|FG001|Participant Flow|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
10943664|NCT00775450|FG002|Participant Flow|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
10943665|NCT00775450|FG003|Participant Flow|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
10943666|NCT00775450|FG004|Participant Flow|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
10943667|NCT00775450|OG000|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
10943668|NCT00775450|OG001|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
10943669|NCT00775450|OG002|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
10943670|NCT00775450|OG003|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
10963521|NCT00872534|EG001|Reported Event|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
10963522|NCT00872599|BG000|Baseline|Study Group|
10943671|NCT00775450|OG004|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
10943672|NCT00775450|EG000|Reported Event|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
10943673|NCT00775450|EG001|Reported Event|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
10943674|NCT00775450|EG002|Reported Event|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
10943675|NCT00775450|EG003|Reported Event|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
10943676|NCT00775450|EG004|Reported Event|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
10943677|NCT00775463|BG000|Baseline|Placebo|intent to treat population
10943678|NCT00775463|BG001|Baseline|Treprostinil Diethanolamine|intent to treat population
10943679|NCT00775463|BG002|Baseline|Total|Total of all reporting groups
10943680|NCT00775463|FG000|Participant Flow|Placebo|All subjects who recieved at least one dose of study drug.
11177419|NCT02040844|OG000|Outcome|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
10943681|NCT00775463|FG001|Participant Flow|Treprostinil Diethanolamine|All subejcts who recieved at least one dose of study drug. One subject in the treprostinil diethanolamine treatment group was randomized, withdrew consent and exited the study prior to taking any study medication and is not included in the analysis summary.
10943682|NCT00775463|OG000|Outcome|Placebo|Placebo intent to treat population
10943683|NCT00775463|OG001|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
10943684|NCT00775463|OG000|Outcome|Placebo|placebo intent to treat population
10943685|NCT00775463|OG000|Outcome|Placebo- Digital Ulcer Response|Placebo intent to treat population
10943686|NCT00775463|OG001|Outcome|Treprostinil Diethanolamine- Digital Ulcer Response|Treprostinil diethanolamine intent to treat population
10943687|NCT00775463|OG002|Outcome|Placebo- Raynaud's Phenomenon Response|Placebo intent to treat population
10943688|NCT00775463|OG003|Outcome|Treprostinil Diethanolamine- Raynaud's Phenomenon Response|Treprostinil diethanolamine intent to treat population
10943689|NCT00775463|OG004|Outcome|Placebo- Overall Disease Status Response|Placebo intent to treat population
10943690|NCT00775463|OG005|Outcome|Treprostinil Diethanolamine- Overall Disease Status Response|Treprostinil diethanolamine intent to treat population
10943691|NCT00775463|EG000|Reported Event|Placebo|
10943692|NCT00775463|EG001|Reported Event|Treprostinil Diethanolamine|
10943693|NCT00775528|BG000|Baseline|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
10943694|NCT00775528|FG000|Participant Flow|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
10943695|NCT00775528|OG000|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
10943696|NCT00775528|EG000|Reported Event|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
10943697|NCT00775593|BG000|Baseline|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
10943698|NCT00775593|FG000|Participant Flow|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
10943699|NCT00775593|OG000|Outcome|Study Group|Evaluable patients
10943700|NCT00775593|EG000|Reported Event|Study Group|Evaluable patients
10943701|NCT00775606|BG000|Baseline|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
10943702|NCT00775606|BG001|Baseline|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
10943703|NCT00775606|BG002|Baseline|Total|Total of all reporting groups
10943704|NCT00775606|FG000|Participant Flow|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
10943705|NCT00775606|FG001|Participant Flow|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
10943706|NCT00775606|OG000|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
10943707|NCT00775606|OG001|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
11177420|NCT02040844|OG001|Outcome|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
11177421|NCT02040844|OG002|Outcome|Placebo|Placebo - 1 dose every 4 weeks
11177422|NCT02040844|EG000|Reported Event|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
10943708|NCT00775606|OG000|Outcome|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
10943709|NCT00775606|OG001|Outcome|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
10943710|NCT00775606|EG000|Reported Event|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
10943711|NCT00775606|EG001|Reported Event|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
10943712|NCT00775645|BG000|Baseline|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
10943713|NCT00775645|BG001|Baseline|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
10943714|NCT00775645|BG002|Baseline|Total|Total of all reporting groups
10943715|NCT00775645|FG000|Participant Flow|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
10943716|NCT00775645|FG001|Participant Flow|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
10943717|NCT00775645|OG000|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
10943718|NCT00775645|OG001|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
10943719|NCT00775645|EG000|Reported Event|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
10943720|NCT00775645|EG001|Reported Event|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
10943721|NCT00775658|BG000|Baseline|All Participants|Includes both groups of participants
10943722|NCT00775658|FG000|Participant Flow|Olopatadine Then Placebo|participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
10943723|NCT00775658|FG001|Participant Flow|Placebo Then Olopatadine|participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
10943724|NCT00775658|OG000|Outcome|Olopatadine|double blind crossover
10943725|NCT00775658|OG001|Outcome|Placebo|
10943726|NCT00775658|EG000|Reported Event|Olopatadine|double blind crossover
10943727|NCT00775658|EG001|Reported Event|Placebo|
10943728|NCT00775671|BG000|Baseline|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
11177423|NCT02040844|EG001|Reported Event|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
10943729|NCT00775671|BG001|Baseline|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
10943730|NCT00775671|BG002|Baseline|Total|Total of all reporting groups
10943731|NCT00775671|FG000|Participant Flow|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
10943732|NCT00775671|FG001|Participant Flow|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
10943733|NCT00775671|OG000|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
10943734|NCT00775671|OG001|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
10943735|NCT00775671|EG000|Reported Event|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
10943736|NCT00775671|EG001|Reported Event|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
10943737|NCT00775931|BG000|Baseline|Marrow Graft Transplant Conditioning|"Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.~Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.~Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).~Busulfan: patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.~Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only."
10943738|NCT00775931|BG001|Baseline|Cord Blood Transplant Conditioning|"Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.~Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.~Busulfan: patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.~Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving"
10943739|NCT00775931|BG002|Baseline|Total|Total of all reporting groups
10963523|NCT00872599|FG000|Participant Flow|Placebo, Then Fenofibrate|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received matching placebo. During the second they received fenofibrate 160mg/d.
10963524|NCT00872599|FG001|Participant Flow|Fenofibrate, Then Placebo|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received fenofibrate 160mg/d. During the second they received matching placebo.
10963525|NCT00872599|OG000|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
10963526|NCT00872599|OG001|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
11177424|NCT02040844|EG002|Reported Event|Placebo|Placebo - 1 dose every 4 weeks
11177425|NCT02040870|BG000|Baseline|LDK378|daily dosing, 28-day cycle patients
11177426|NCT02040870|FG000|Participant Flow|LDK378|daily dosing, 28-day cycle patients
10943740|NCT00775931|FG000|Participant Flow|Marrow Graft Transplant Conditioning|"Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.~Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.~Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).~Busulfan: patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.~Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only."
10943741|NCT00775931|FG001|Participant Flow|Cord Blood Transplant Conditioning|"Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.~Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.~Busulfan: patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.~Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving"
10943742|NCT00775931|OG000|Outcome|Marrow Graft Transplant Conditioning|"Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.~Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.~Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).~Busulfan: patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.~Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only."
10943743|NCT00775931|OG001|Outcome|Cord Blood Transplant Conditioning|"Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.~Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.~Busulfan: patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.~Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving"
10943744|NCT00775931|EG000|Reported Event|Marrow Graft Transplant Conditioning|"Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.~Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.~Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).~Busulfan: patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.~Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only."
10943745|NCT00775931|EG001|Reported Event|Cord Blood Transplant Conditioning|"Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.~Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.~Busulfan: patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.~Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving"
10943746|NCT00775944|BG000|Baseline|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
10943747|NCT00775944|BG001|Baseline|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
10943748|NCT00775944|BG002|Baseline|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
10943749|NCT00775944|BG003|Baseline|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
10943750|NCT00775944|BG004|Baseline|Total|Total of all reporting groups
10943751|NCT00775944|FG000|Participant Flow|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
10943752|NCT00775944|FG001|Participant Flow|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
10943753|NCT00775944|FG002|Participant Flow|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
10943754|NCT00775944|FG003|Participant Flow|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
10943755|NCT00775944|OG000|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
10943756|NCT00775944|OG001|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
10963527|NCT00872599|EG000|Reported Event|Placebo|
10963528|NCT00872599|EG001|Reported Event|Fenofibrate|
10943757|NCT00775944|OG002|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
10943758|NCT00775944|OG003|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
10943759|NCT00775944|EG000|Reported Event|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
10943760|NCT00775944|EG001|Reported Event|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
10943761|NCT00775944|EG002|Reported Event|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
10943762|NCT00775944|EG003|Reported Event|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
10943763|NCT00775983|BG000|Baseline|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
10943764|NCT00775983|BG001|Baseline|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
10943765|NCT00775983|BG002|Baseline|Total|Total of all reporting groups
10943766|NCT00775983|FG000|Participant Flow|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
10943767|NCT00775983|FG001|Participant Flow|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
10943768|NCT00775983|OG000|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
10943769|NCT00775983|OG001|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
10943770|NCT00775983|EG000|Reported Event|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
10943771|NCT00775983|EG001|Reported Event|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
10943772|NCT00776009|BG000|Baseline|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
10943773|NCT00776009|BG001|Baseline|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
10943774|NCT00776009|BG002|Baseline|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
10943775|NCT00776009|BG003|Baseline|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
10943776|NCT00776009|BG004|Baseline|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
10943777|NCT00776009|BG005|Baseline|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
10943778|NCT00776009|BG006|Baseline|Total|Total of all reporting groups
10943779|NCT00776009|FG000|Participant Flow|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
10943780|NCT00776009|FG001|Participant Flow|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
10943781|NCT00776009|FG002|Participant Flow|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
10943782|NCT00776009|FG003|Participant Flow|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
10943783|NCT00776009|FG004|Participant Flow|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
10943784|NCT00776009|FG005|Participant Flow|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
10943785|NCT00776009|OG000|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
10943786|NCT00776009|OG001|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
10943787|NCT00776009|OG002|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
10943788|NCT00776009|EG000|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
11177427|NCT02040870|OG000|Outcome|LDK378|daily dosing, 28-day cycle patients
11177428|NCT02040870|EG000|Reported Event|LDK378|daily dosing, 28-day cycle patients
10943789|NCT00776009|EG001|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
10943790|NCT00776009|EG002|Reported Event|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
10943791|NCT00776230|BG000|Baseline|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
10943792|NCT00776230|BG001|Baseline|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
10943793|NCT00776230|BG002|Baseline|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
10943794|NCT00776230|BG003|Baseline|Total|Total of all reporting groups
10943795|NCT00776230|FG000|Participant Flow|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
10943796|NCT00776230|FG001|Participant Flow|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
10943797|NCT00776230|FG002|Participant Flow|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
10943798|NCT00776230|OG000|Outcome|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
10943799|NCT00776230|OG001|Outcome|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
10943800|NCT00776230|OG002|Outcome|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
10943801|NCT00776230|EG000|Reported Event|IC51 Cohort 1|
10943802|NCT00776230|EG001|Reported Event|IC51 Cohort 2|
10943803|NCT00776230|EG002|Reported Event|IC51 Cohort 3|
10943804|NCT00776295|BG000|Baseline|p53 Vaccination|Dendritic cell p53 vaccination
10943805|NCT00776295|FG000|Participant Flow|p53 Vaccination|Dendritic cell p53 vaccination
10943806|NCT00776295|OG000|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
10943807|NCT00776295|EG000|Reported Event|Biological/Vaccine|Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expaned T-lymphocytes
10943808|NCT00776594|BG000|Baseline|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
10943809|NCT00776594|BG001|Baseline|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
10943810|NCT00776594|BG002|Baseline|Total|Total of all reporting groups
10943811|NCT00776594|FG000|Participant Flow|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
10963529|NCT00872729|BG000|Baseline|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg.
11177429|NCT02041091|BG000|Baseline|Tabalumab Prefilled Syringe|Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
11177430|NCT02041091|BG001|Baseline|Tabalumab Auto-Injector|Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
11177431|NCT02041091|BG002|Baseline|Total|Total of all reporting groups
11240723|NCT02481375|FG002|Participant Flow|Iron Only|"This formulation only has 60 mg elemental iron.~Women will receive iron for 12 weeks.~Iron: 12-wk supplementation of iron"
10943812|NCT00776594|FG001|Participant Flow|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
10943813|NCT00776594|OG000|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
10943814|NCT00776594|OG001|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
10943815|NCT00776594|OG000|Outcome|Leptin Level in Patients Treated With ADT+Bev|Leptin level in patients with sample available treated with ADT+bev
10943816|NCT00776594|OG001|Outcome|Leptin in Patients Treated With ADT Alone|Leptin in patients with sample available treated with ADT alone
10943817|NCT00776594|EG000|Reported Event|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
10943818|NCT00776594|EG001|Reported Event|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
10943819|NCT00776659|BG000|Baseline|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
10943820|NCT00776659|FG000|Participant Flow|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
10943821|NCT00776659|OG000|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
10943822|NCT00776659|EG000|Reported Event|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
10943823|NCT00776789|BG000|Baseline|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
10943824|NCT00776789|BG001|Baseline|Control Group|baby will be kept by the mothers side and not given skin to skin contact
11177432|NCT02041091|FG000|Participant Flow|Tabalumab Prefilled Syringe|"Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.~The treatment regimen from Week 12 to Week 52 is an Optional Safety Extension Period.~All participants will participate in a Post-Treatment Follow-Up Period regardless of their participation in the Optional Safety Extension Period."
10943825|NCT00776789|BG002|Baseline|Total|Total of all reporting groups
10943826|NCT00776789|FG000|Participant Flow|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
10943827|NCT00776789|FG001|Participant Flow|Control Group|baby will be kept by the mothers side and not given skin to skin contact
10943828|NCT00776789|OG000|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
10943829|NCT00776789|OG001|Outcome|Control Group|Baby will be kept by the mothers side and not given skin to skin contact
10943830|NCT00776789|OG001|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
10943831|NCT00776789|OG001|Outcome|Control Group|Babies will be kept by the mothers side and not given skin to skin contact
10943832|NCT00776789|EG000|Reported Event|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
10943833|NCT00776789|EG001|Reported Event|Control Group|baby will be kept by the mothers side and not given skin to skin contact
10943834|NCT00776919|BG000|Baseline|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943835|NCT00776919|BG001|Baseline|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943836|NCT00776919|BG002|Baseline|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
11240724|NCT02481375|FG003|Participant Flow|Placebo|"This formulation is a placebo.~Women will receive a placebo for 12 weeks.~Placebo: 12-wk supplementation of placebo"
10943837|NCT00776919|BG003|Baseline|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943838|NCT00776919|BG004|Baseline|Total|Total of all reporting groups
10943839|NCT00776919|FG000|Participant Flow|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943840|NCT00776919|FG001|Participant Flow|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943841|NCT00776919|FG002|Participant Flow|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943842|NCT00776919|FG003|Participant Flow|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943843|NCT00776919|OG000|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943844|NCT00776919|OG001|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943845|NCT00776919|OG002|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943846|NCT00776919|OG003|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943847|NCT00776919|EG000|Reported Event|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943848|NCT00776919|EG001|Reported Event|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943849|NCT00776919|EG002|Reported Event|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943850|NCT00776919|EG003|Reported Event|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
10943851|NCT00776984|BG000|Baseline|Placebo|Patients treated with matching placebo
10943852|NCT00776984|BG001|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
10943853|NCT00776984|BG002|Baseline|Total|Total of all reporting groups
10943854|NCT00776984|FG000|Participant Flow|Placebo|Patients treated with matching placebo
10943855|NCT00776984|FG001|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
10943856|NCT00776984|OG000|Outcome|Placebo|Patients treated with matching placebo
10943857|NCT00776984|OG001|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
10943858|NCT00776984|EG000|Reported Event|Placebo|Patients treated with matching placebo
10943859|NCT00776984|EG001|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
10943860|NCT00776997|BG000|Baseline|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
10943861|NCT00776997|FG000|Participant Flow|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
10943862|NCT00776997|OG000|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
10943863|NCT00776997|EG000|Reported Event|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
10943864|NCT00777023|BG000|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
10943865|NCT00777023|BG001|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
10943866|NCT00777023|BG002|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
10943867|NCT00777023|BG003|Baseline|Total|Total of all reporting groups
10943868|NCT00777023|FG000|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
10943869|NCT00777023|FG001|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
10943870|NCT00777023|FG002|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
10943871|NCT00777023|OG000|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
10943872|NCT00777023|OG001|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
10943873|NCT00777023|OG002|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
10943874|NCT00777023|EG000|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
10943875|NCT00777023|EG001|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
10943876|NCT00777023|EG002|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
10943877|NCT00777049|BG000|Baseline|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
10943878|NCT00777049|BG001|Baseline|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
10943879|NCT00777049|BG002|Baseline|Total|Total of all reporting groups
10943880|NCT00777049|FG000|Participant Flow|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
10943881|NCT00777049|FG001|Participant Flow|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
10943882|NCT00777049|OG000|Outcome|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
10943883|NCT00777049|OG001|Outcome|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
10943884|NCT00777049|EG000|Reported Event|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
10943885|NCT00777049|EG001|Reported Event|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
10943886|NCT00777062|BG000|Baseline|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
10943887|NCT00777062|BG001|Baseline|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
10943888|NCT00777062|BG002|Baseline|Total|Total of all reporting groups
10943889|NCT00777062|FG000|Participant Flow|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
10943890|NCT00777062|FG001|Participant Flow|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
10943891|NCT00777062|OG000|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
10943892|NCT00777062|OG001|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
10943893|NCT00777062|EG000|Reported Event|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
10943894|NCT00777062|EG001|Reported Event|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
10943895|NCT00777088|BG000|Baseline|Pipeline|"Placement of Pipeline Embolization Device in the parent artery at the aneurysm location~Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach"
10943896|NCT00777088|FG000|Participant Flow|Pipeline|"Placement of Pipeline Embolization Device in the parent artery at the aneurysm location~Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach"
10943897|NCT00777088|OG000|Outcome|Pipeline|"Placement of Pipeline Embolization Device in the parent artery at the aneurysm location~Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach"
10943898|NCT00777088|OG000|Outcome|Pipeline|Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
10943899|NCT00777088|EG000|Reported Event|Pipeline|"Placement of Pipeline Embolization Device in the parent artery at the aneurysm location~Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach"
10943900|NCT00777101|BG000|Baseline|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
10943901|NCT00777101|BG001|Baseline|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
10943902|NCT00777101|BG002|Baseline|Total|Total of all reporting groups
10943903|NCT00777101|FG000|Participant Flow|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
10943904|NCT00777101|FG001|Participant Flow|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
10943905|NCT00777101|OG000|Outcome|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
10943906|NCT00777101|OG001|Outcome|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
10943907|NCT00777101|OG001|Outcome|Lapatinib+Capecitabine|"Lapatinib+Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
10943908|NCT00777101|EG000|Reported Event|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
10943909|NCT00777101|EG001|Reported Event|Lapatinib+Capecitabine|"Lapatinib+Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
10943910|NCT00777153|BG000|Baseline|Cediranib 30mg|Cediranib 30mg/Day
10943911|NCT00777153|BG001|Baseline|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
10943912|NCT00777153|BG002|Baseline|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
10943913|NCT00777153|BG003|Baseline|Total|Total of all reporting groups
10943914|NCT00777153|FG000|Participant Flow|Cediranib 30mg|Cediranib 30mg/Day
10943915|NCT00777153|FG001|Participant Flow|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
10943916|NCT00777153|FG002|Participant Flow|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
10943917|NCT00777153|OG000|Outcome|Cediranib 30mg|Cediranib 30mg/Day
10943918|NCT00777153|OG001|Outcome|Cediranib 20mg+ Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
10943919|NCT00777153|OG002|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
10943920|NCT00777153|OG001|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
10943921|NCT00777153|OG001|Outcome|Cediranib 20mg + Lomustine 100mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
10943922|NCT00777153|OG002|Outcome|Lomustine 100mg|Lomustine 110mg/m2/Day + Placebo cediranib
10943923|NCT00777153|OG001|Outcome|Cediranib 20mg + Lomustine 119mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
10943924|NCT00777153|EG000|Reported Event|Cediranib 30mg|Cediranib 30mg/Day
10943925|NCT00777153|EG001|Reported Event|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
10943926|NCT00777153|EG002|Reported Event|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
10943927|NCT00777179|BG000|Baseline|Vandetanib|Vandetanib 300 mg, orally, once daily
10943928|NCT00777179|BG001|Baseline|Placebo|Matching Placebo
10943929|NCT00777179|BG002|Baseline|Total|Total of all reporting groups
10943930|NCT00777179|FG000|Participant Flow|Vandetanib|Vandetanib 300 mg, orally, once daily
10943931|NCT00777179|FG001|Participant Flow|Placebo|Matching Placebo
10943932|NCT00777179|OG000|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
10943933|NCT00777179|OG001|Outcome|Placebo|Matching Placebo
10943934|NCT00777179|EG000|Reported Event|Vandetanib|Vandetanib 300 mg, orally, once daily
10943935|NCT00777179|EG001|Reported Event|Placebo|Matching Placebo
10943936|NCT00777205|BG000|Baseline|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
10943937|NCT00777205|BG001|Baseline|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
10943938|NCT00777205|BG002|Baseline|Total|Total of all reporting groups
10943939|NCT00777205|FG000|Participant Flow|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
10943940|NCT00777205|FG001|Participant Flow|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
10943941|NCT00777205|OG000|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
10943942|NCT00777205|OG001|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
10943943|NCT00777205|OG000|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
10943944|NCT00777205|OG001|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
10943945|NCT00777205|EG000|Reported Event|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
10943946|NCT00777205|EG001|Reported Event|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
10943947|NCT00777257|BG000|Baseline|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
10943948|NCT00777257|BG001|Baseline|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
10943949|NCT00777257|BG002|Baseline|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
10943950|NCT00777257|BG003|Baseline|Total|Total of all reporting groups
10943951|NCT00777257|FG000|Participant Flow|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
10943952|NCT00777257|FG001|Participant Flow|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
10943953|NCT00777257|FG002|Participant Flow|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
10943954|NCT00777257|OG000|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
10943955|NCT00777257|OG001|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
10943956|NCT00777257|OG002|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
10943957|NCT00777257|EG000|Reported Event|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
10943958|NCT00777257|EG001|Reported Event|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
10943959|NCT00777257|EG002|Reported Event|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
10943960|NCT00777296|BG000|Baseline|Cohort 1 - 280 mg ARIKACE™|Subjects in this cohort received 280 mg of ARIKACE™
10943961|NCT00777296|BG001|Baseline|Cohort 1 - Placebo|Subjects in this arm of cohort 1 received matching placebo
10943962|NCT00777296|BG002|Baseline|Cohort 2 - 560 mg ARIKACE™|Subjects in this cohort received 560 mg of ARIKACE™
10943963|NCT00777296|BG003|Baseline|Cohort 2 - Placebo|Subjects in this arm of cohort 2 received matching placebo
10943964|NCT00777296|BG004|Baseline|Total|Total of all reporting groups
10943965|NCT00777296|FG000|Participant Flow|Cohort 1 - 280 mg ARIKACE™|Subjects in this cohort received 280 mg of ARIKACE™
10943966|NCT00777296|FG001|Participant Flow|Cohort 1 - Placebo|Subjects in this arm of cohort 1 received matching placebo
10943967|NCT00777296|FG002|Participant Flow|Cohort 2 - 560 mg ARIKACE™|Subjects in this cohort received 560 mg of ARIKACE™
10943968|NCT00777296|FG003|Participant Flow|Cohort 2 - Placebo|Subjects in this arm of cohort 2 received matching placebo
10943969|NCT00777296|OG000|Outcome|Cohort 1 - 280 mg ARIKACE™|Subjects in this cohort received 280 mg of ARIKACE™
10943970|NCT00777296|OG001|Outcome|Cohort 1 - Placebo|Subjects in this cohort who received placebo
10943971|NCT00777296|OG002|Outcome|Cohort 2 - 560 mg ARIKACE™|Subjects in this cohort received 560 mg of ARIKACE™
10943972|NCT00777296|OG003|Outcome|Cohort 2 - Placebo|Subjects in this cohort received matching placebo
11177433|NCT02041091|FG001|Participant Flow|Tabalumab Auto-Injector|"Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.~The treatment regimen from Week 12 to Week 52 is an Optional Safety Extension Period.~All participants will participate in a Post-Treatment Follow-Up Period regardless of their participation in the Optional Safety Extension Period."
10943973|NCT00777296|OG001|Outcome|Cohort 2 - 560 mg ARIKACE™|Subjects in this cohort received 560 mg of ARIKACE™
10943974|NCT00777296|OG000|Outcome|280 mg ARIKACE™|Subjects in this cohort received 280 mg of ARIKACE™
10943975|NCT00777296|OG001|Outcome|560 mg ARIKACE™|Subjects in this cohort received 560 mg of ARIKACE™
10943976|NCT00777296|OG002|Outcome|Pooled Placebo|Subjects in this arm received matching placebo
11341672|NCT03686176|OG001|Outcome|Standard Care (Control Group)|In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.
10943977|NCT00777296|OG000|Outcome|ARIKACE™ 280 mg|Subjects who received the 280 mg dose of the ARIKACE™
10943978|NCT00777296|OG001|Outcome|Placebo for ARIKACE™ 280 mg|Subjects who received matching placebo for ARIKACE™ 280 mg dose.
10943979|NCT00777296|OG002|Outcome|ARIKACE™ 560 mg|Subjects who received the 560 mg dose of the ARIKACE™
10943980|NCT00777296|OG003|Outcome|Placebo for ARIKACE™ 560 mg|Subjects who received matching placebo for ARIKACE™ 560 mg dose.
10943981|NCT00777296|OG000|Outcome|ARIKACE™|Subjects who received either the 280 mg or the 560 mg doses of the ARIKACE™
10943982|NCT00777296|OG001|Outcome|Placebo|Subjects who received matching placebo.
10943983|NCT00777296|OG001|Outcome|Cohort 1 - Placebo|Subjects in this arm of cohort 1 received matching placebo
10943984|NCT00777296|OG003|Outcome|Cohort 2 - Placebo|Subjects in this arm of cohort 2 received matching placebo
10943985|NCT00777296|EG000|Reported Event|Cohort 1 - 280 mg ARIKACE™|Subjects in this cohort will receive 280 mg of ARIKACE™
10943986|NCT00777296|EG001|Reported Event|Cohort 1 - Placebo|Subjects in this arm of cohort 1 will receive matching placebo
10943987|NCT00777296|EG002|Reported Event|Cohort 2 - 560 mg ARIKACE™|Subjects in this cohort will receive 560 mg of ARIKACE™
10943988|NCT00777296|EG003|Reported Event|Cohort 2 - Placebo|Subjects in this arm of cohort 2 will receive matching placebo
10943989|NCT00777335|BG000|Baseline|Panobinostat Intra-venous (i.v.)|
10943990|NCT00777335|BG001|Baseline|Panobinostat Oral|
10943991|NCT00777335|BG002|Baseline|Total|Total of all reporting groups
10943992|NCT00777335|FG000|Participant Flow|Panobinostat Intra-venous (i.v.)|
10943993|NCT00777335|FG001|Participant Flow|Panobinostat Oral|
10943994|NCT00777335|OG000|Outcome|Panobinostat Intra-venous (i.v.)|
10943995|NCT00777335|OG001|Outcome|Panobinostat Oral|
10943996|NCT00777335|EG000|Reported Event|Panobinostat Intra-venous (i.v.)|
10943997|NCT00777335|EG001|Reported Event|Panobinostat Oral|
10943998|NCT00777556|BG000|Baseline|DR-104|One tablet for emergency contraception
10943999|NCT00777556|FG000|Participant Flow|DR-104|One tablet for emergency contraception
10944000|NCT00777556|OG000|Outcome|DR-104|One tablet for emergency contraception
10944001|NCT00777556|EG000|Reported Event|DR-104|One tablet for emergency contraception
10944002|NCT00777608|BG000|Baseline|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
10944003|NCT00777608|BG001|Baseline|Placebo|Participants were randomized to placebo for 84 days
10944004|NCT00777608|BG002|Baseline|Total|Total of all reporting groups
10944005|NCT00777608|FG000|Participant Flow|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
10944006|NCT00777608|FG001|Participant Flow|Placebo|Participants were randomized to placebo for 84 days
10944007|NCT00777608|OG000|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
10944008|NCT00777608|OG001|Outcome|Placebo|Participants were randomized to placebo for 84 days
10944009|NCT00777608|EG000|Reported Event|Donezepil 5-10 mg|Participants were randomized to donepezil for 84 days
10944010|NCT00777608|EG001|Reported Event|Placebo|Participants were randomized to placebo for 84 days
10944011|NCT00777634|BG000|Baseline|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
10944012|NCT00777634|BG001|Baseline|Without BED|Individuals who do not meet criteria for binge eating disorder.
10944013|NCT00777634|BG002|Baseline|Total|Total of all reporting groups
10944014|NCT00777634|FG000|Participant Flow|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
10944015|NCT00777634|FG001|Participant Flow|Without BED|Individuals who do not meet criteria for binge eating disorder.
10944016|NCT00777634|OG000|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
10944017|NCT00777634|OG001|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
10944018|NCT00777634|EG000|Reported Event|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
10944019|NCT00777634|EG001|Reported Event|Without BED|Individuals who do not meet criteria for binge eating disorder.
10944020|NCT00777764|BG000|Baseline|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
10944021|NCT00777764|BG001|Baseline|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
10944022|NCT00777764|BG002|Baseline|Total|Total of all reporting groups
10944023|NCT00777764|FG000|Participant Flow|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
10944024|NCT00777764|FG001|Participant Flow|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
10944025|NCT00777764|OG000|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
10944026|NCT00777764|OG001|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
10944027|NCT00777764|OG000|Outcome|Healthy Subjects|
10944028|NCT00777764|OG000|Outcome|Patients With Allergic Asthma|
10944029|NCT00777764|EG000|Reported Event|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
10944030|NCT00777764|EG001|Reported Event|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
10944031|NCT00777790|BG000|Baseline|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
10944032|NCT00777790|BG001|Baseline|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
10944033|NCT00777790|BG002|Baseline|Control Group|Meningococcal vaccine-naïve subjects
10944034|NCT00777790|BG003|Baseline|Total|Total of all reporting groups
10944035|NCT00777790|FG000|Participant Flow|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
10944036|NCT00777790|FG001|Participant Flow|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
10944037|NCT00777790|FG002|Participant Flow|Control Group|Meningococcal vaccine-naïve subjects
10944038|NCT00777790|OG000|Outcome|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
10944039|NCT00777790|OG001|Outcome|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
10944040|NCT00777790|OG002|Outcome|Control Group|Meningococcal vaccine-naïve subjects
10944041|NCT00777790|EG000|Reported Event|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
10944042|NCT00777790|EG001|Reported Event|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
10944043|NCT00777790|EG002|Reported Event|Control Group|Meningococcal vaccine-naïve subjects
10944044|NCT00777803|BG000|Baseline|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
10944045|NCT00777803|BG001|Baseline|OnabotulinumtoxinA (Vistabel®)|
10944046|NCT00777803|BG002|Baseline|Total|Total of all reporting groups
10944047|NCT00777803|FG000|Participant Flow|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
10944048|NCT00777803|FG001|Participant Flow|OnabotulinumtoxinA (Vistabel®)|
10944049|NCT00777803|OG000|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
10944050|NCT00777803|OG001|Outcome|OnabotulinumtoxinA (Vistabel®)|
10944051|NCT00777803|EG000|Reported Event|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
10944052|NCT00777803|EG001|Reported Event|OnabotulinumtoxinA (Vistabel®)|
10944053|NCT00777829|BG000|Baseline|All Participants|This was a within-subjects design, so all 30 started in the participant flow, but only 28 completed all arms of the study.
10944054|NCT00777829|FG000|Participant Flow|Zolpidem First, Then Placebo|Participants received one dose of zolpidem for one nap, then had a one week washout period, followed by once dose of placebo for one nap.
10944055|NCT00777829|FG001|Participant Flow|Placebo First, Then Zolpidem|Participants received one dose of placebo for one nap, then had a one week washout period, followed by once dose of zolpidem for one nap.
10944056|NCT00777829|OG000|Outcome|Zolpidem|This arm reflects all participants who received the drug (one dose of 10mg before each nap) during the entire course of the study.
11177434|NCT02041091|OG000|Outcome|Tabalumab Prefilled Syringe|"Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.~Tabalumab Prefilled Syringe: Administered SC"
10944057|NCT00777829|OG001|Outcome|Placebo|This arm reflects all participants who received the placebo (a dose of placebo before each nap) during the entire course of the study.
10944058|NCT00777829|OG000|Outcome|Zolpidem|This arm reflects all participants who received the drug (1 dose of 10mg before each nap) during the entire course of the study.
10944059|NCT00777829|OG001|Outcome|Placebo|This arm reflects all participants who received the placebo (1 dose of placebo before each nap) during the entire course of the study.
10944060|NCT00777829|EG000|Reported Event|Zolpidem|This arm reflects all participants who received the drug (1 dose of 10mg before each nap) during the entire course of the study.
10944061|NCT00777829|EG001|Reported Event|Placebo|This arm reflects all participants who received the placebo (1 dose of placebo before each nap) during the entire course of the study.
10944062|NCT00777855|BG000|Baseline|Entire Study Population|Includes participants randomized to receive warfarin alone then warfarin+rifampin, and those randomized to receive warfarin+rifampin then warfarin alone in the crossover design
10944063|NCT00777855|FG000|Participant Flow|Warfarin First, Then Warfarin+Rifampin|In a randomized, single-dose, two-period, crossover design, 5 participants received warfarin alone 7.5mg po; after a minimum of 14 days, participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po.
10944064|NCT00777855|FG001|Participant Flow|Warfarin+Rifampin First, Then Warfarin Alone|In a randomized, single-dose, two-period, crossover design, 5 participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po; after a minimum of 14 days, participants received warfarin alone 7.5mg po.
10944065|NCT00777855|OG000|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
10944066|NCT00777855|OG001|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
10944067|NCT00777855|EG000|Reported Event|Entire Study Population|Each of 10 participants received both study treatments, in randomly assigned sequence, separated by a minimum of 14 days
10944068|NCT00777920|BG000|Baseline|Ambrisentan|Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
10944069|NCT00777920|FG000|Participant Flow|Ambrisentan|Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
10944070|NCT00777920|OG000|Outcome|Ambrisentan|Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
10944071|NCT00777920|EG000|Reported Event|Ambrisentan|Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
10944072|NCT00777946|BG000|Baseline|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
10944073|NCT00777946|BG001|Baseline|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
10944074|NCT00777946|BG002|Baseline|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
11357655|NCT03751020|OG001|Outcome|Expressive Writing (EW)|"Expressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.~Expressive Writing (EW) Intervention: The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered."
11357656|NCT03751020|OG002|Outcome|Self-Affirmation (SA)|"Self-Affirmation (SA) interventions prompt individuals to write advice to a (hypothetical) similarly stigmatized person regarding how best to cope with stigma-related stress. By affirming one's own stigmatized identity through the process of helping another similarly stigmatized person.~Self-Affirmation (SA) Intervention: The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences."
11357657|NCT03751020|EG000|Reported Event|Control|"Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days.~Control: Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies."
11357658|NCT03751020|EG001|Reported Event|Expressive Writing (EW)|"Expressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.~Expressive Writing (EW) Intervention: The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered."
10944075|NCT00777946|BG003|Baseline|Total|Total of all reporting groups
10944076|NCT00777946|FG000|Participant Flow|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
10944077|NCT00777946|FG001|Participant Flow|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
10944078|NCT00777946|FG002|Participant Flow|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
10944079|NCT00777946|OG000|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
10944080|NCT00777946|OG001|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
10944081|NCT00777946|OG002|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
10944082|NCT00777946|EG000|Reported Event|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
10944083|NCT00777946|EG001|Reported Event|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
10944084|NCT00777946|EG002|Reported Event|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
10944085|NCT00778102|BG000|Baseline|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
10944086|NCT00778102|BG001|Baseline|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
10944087|NCT00778102|BG002|Baseline|Total|Total of all reporting groups
10963530|NCT00872729|FG000|Participant Flow|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg; Single-dose, open-label, nonrandomized, 2-period, crossover study of cysteamine bitartrate delayed-release capsules (RP103) and Cystagon®. Subjects were enrolled sequentially and received Cystagon® first followed by RP103.
10963531|NCT00872729|OG000|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10944088|NCT00778102|FG000|Participant Flow|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX-6). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 milligrams per kilogram (mg/kg) via intravenous (IV) infusion; oxaliplatin 85 milligrams per meter-squared (mg/m^2) via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, progressive disease (PD), unacceptable toxicity, or participant refusal.
10944089|NCT00778102|FG001|Participant Flow|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, irinotecan, leucovorin, and 5-FU (FOLFOXIRI). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
10944090|NCT00778102|OG000|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
10944091|NCT00778102|OG001|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
10944092|NCT00778102|EG000|Reported Event|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
10944093|NCT00778102|EG001|Reported Event|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
10944094|NCT00778167|BG000|Baseline|Cohort 1|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
10944095|NCT00778167|BG001|Baseline|Cohort 2|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
10944096|NCT00778167|BG002|Baseline|Cohort 3|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
10944097|NCT00778167|BG003|Baseline|Total|Total of all reporting groups
10944098|NCT00778167|FG000|Participant Flow|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
10944099|NCT00778167|FG001|Participant Flow|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
11177435|NCT02041091|OG001|Outcome|Tabalumab Auto-Injector|"Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.~Tabalumab Auto-Injector: Administered SC"
10944100|NCT00778167|FG002|Participant Flow|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
10944101|NCT00778167|OG000|Outcome|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
10944102|NCT00778167|OG001|Outcome|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
10944103|NCT00778167|OG002|Outcome|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
10944104|NCT00778167|EG000|Reported Event|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
10944105|NCT00778167|EG001|Reported Event|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
10944106|NCT00778167|EG002|Reported Event|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
10944107|NCT00778258|BG000|Baseline|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944108|NCT00778258|BG001|Baseline|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944109|NCT00778258|BG002|Baseline|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944110|NCT00778258|BG003|Baseline|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944111|NCT00778258|BG004|Baseline|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944112|NCT00778258|BG005|Baseline|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944113|NCT00778258|BG006|Baseline|Not Randomized - Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
10944114|NCT00778258|BG007|Baseline|Non-Randomized - Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
10944115|NCT00778258|BG008|Baseline|Non-Randomized - Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
10944116|NCT00778258|BG009|Baseline|Total|Total of all reporting groups
11177436|NCT02041091|OG000|Outcome|Total PK Population|Total participants randomized to prefilled syringe or auto-injector arm from randomization through week 61.
11177437|NCT02041091|OG000|Outcome|Tabalumab Auto-Injector|"Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.~Tabalumab Auto-Injector: Administered SC"
11177438|NCT02041091|EG000|Reported Event|Tabalumab Prefilled Syringe Treatment|Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks.
11177439|NCT02041091|EG001|Reported Event|Tabalumab Auto-Injector Treatment|Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks.
11177440|NCT02041091|EG002|Reported Event|Prefilled Syringe Optional Safety Extension|Tabalumab given SC every two weeks from Week 12 to Week 52.
11177441|NCT02041091|EG003|Reported Event|Auto-Injector Optional Safety Extension|Tabalumab given every two weeks from Week 12 to Week 52.
10963532|NCT00872729|OG001|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10963533|NCT00872729|OG000|Outcome|Cystagon® (0.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10963534|NCT00872729|OG001|Outcome|RP103 (0.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
11177442|NCT02041091|EG004|Reported Event|Prefilled Syringe Follow Up|Follow Up 24-48 weeks post last doseTabalumab
11177443|NCT02041091|EG005|Reported Event|Auto-Injector Follow Up|Follow Up 24-48 weeks post last doseTabalumab
10944117|NCT00778258|FG000|Participant Flow|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944118|NCT00778258|FG001|Participant Flow|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944119|NCT00778258|FG002|Participant Flow|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944120|NCT00778258|FG003|Participant Flow|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944121|NCT00778258|FG004|Participant Flow|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944122|NCT00778258|FG005|Participant Flow|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944123|NCT00778258|FG006|Participant Flow|Not Randomized - Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
10944124|NCT00778258|FG007|Participant Flow|Non-Randomized - Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
10944125|NCT00778258|FG008|Participant Flow|Non-Randomized - Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
10944126|NCT00778258|OG000|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
11177444|NCT02041104|BG000|Baseline|Bread With Added Beta-glucans|"Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. Experimental bread was prepared with concentrated beta-glucans barley flour, containing up to 15 % of beta-glucans.~Bread with added beta-glucans: Participants daily consumed bread with a high content of beta-glucans. They approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics"
11341673|NCT03686176|OG002|Outcome|Reference Group|No virtual reality and no child life specialists; no standardized or formal form of support.
10944127|NCT00778258|OG001|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
10944128|NCT00778258|OG000|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
10944129|NCT00778258|OG001|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
10944130|NCT00778258|OG000|Outcome|Group 2 - Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
10944131|NCT00778258|OG001|Outcome|Group 3 - Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
11177445|NCT02041104|BG001|Baseline|Bread Without Added Beta-glucans|"Placebo bread without added barley beta-glucans in the testing product.~Placebo Comparator: Bread without added beta-glucans: Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). Intervention period will be 4 weeks. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics."
11177446|NCT02041104|BG002|Baseline|Total|Total of all reporting groups
10944132|NCT00778258|OG002|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
10944133|NCT00778258|OG000|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
10944134|NCT00778258|OG001|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
10944135|NCT00778258|OG002|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
10944136|NCT00778258|OG003|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
10944137|NCT00778258|OG004|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
10944138|NCT00778258|OG000|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
10944139|NCT00778258|OG001|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
11177447|NCT02041104|FG000|Participant Flow|Bread With Added Beta-glucans|"Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.~Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics"
10944140|NCT00778258|OG002|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
10944141|NCT00778258|EG000|Reported Event|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944142|NCT00778258|EG001|Reported Event|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944143|NCT00778258|EG002|Reported Event|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944144|NCT00778258|EG003|Reported Event|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10963535|NCT00872729|OG002|Outcome|Cystagon® (1 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10963536|NCT00872729|OG003|Outcome|RP103 (1 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10963537|NCT00872729|OG004|Outcome|Cystagon® (2 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10963538|NCT00872729|OG005|Outcome|RP103 (2 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10944145|NCT00778258|EG004|Reported Event|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944146|NCT00778258|EG005|Reported Event|Maintenance - Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
10944147|NCT00778258|EG006|Reported Event|Not Randomized - Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
10944148|NCT00778258|EG007|Reported Event|Non-Randomized - Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
10944149|NCT00778258|EG008|Reported Event|Non-Randomized - Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
10944150|NCT00778310|BG000|Baseline|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
10944151|NCT00778310|BG001|Baseline|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
10944152|NCT00778310|BG002|Baseline|Total|Total of all reporting groups
10944153|NCT00778310|FG000|Participant Flow|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
10944154|NCT00778310|FG001|Participant Flow|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
10944155|NCT00778310|OG000|Outcome|Adults Drug Condition|This is the BOLD signal data on the Concerta day scan.
10944156|NCT00778310|OG001|Outcome|Adults Placebo Condition|This is the BOLD signal data on the Placebo day scan.
10944157|NCT00778310|OG002|Outcome|Children Drug Condition|This is the BOLD signal data on the Concerta day scan.
10944158|NCT00778310|OG003|Outcome|Children Placebo Condition|This is the BOLD signal data on the Placebo day scan.
10944159|NCT00778310|EG000|Reported Event|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
10944160|NCT00778310|EG001|Reported Event|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
10944161|NCT00778336|BG000|Baseline|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
10944162|NCT00778336|BG001|Baseline|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
10944163|NCT00778336|BG002|Baseline|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
10944164|NCT00778336|BG003|Baseline|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
10944165|NCT00778336|BG004|Baseline|Total|Total of all reporting groups
10944166|NCT00778336|FG000|Participant Flow|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
10944167|NCT00778336|FG001|Participant Flow|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
10944168|NCT00778336|FG002|Participant Flow|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
10944169|NCT00778336|FG003|Participant Flow|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
10944170|NCT00778336|OG000|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
10944171|NCT00778336|OG001|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
10944172|NCT00778336|OG002|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
10944173|NCT00778336|OG003|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
10944174|NCT00778336|EG000|Reported Event|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
10944175|NCT00778336|EG001|Reported Event|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
10944176|NCT00778336|EG002|Reported Event|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
10944177|NCT00778336|EG003|Reported Event|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
10944178|NCT00778375|BG000|Baseline|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
10944179|NCT00778375|FG000|Participant Flow|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 by vein (IV) as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
10944180|NCT00778375|OG000|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
10944181|NCT00778375|OG000|Outcome|Induction Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
10944182|NCT00778375|OG001|Outcome|Re-Induction|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
10944183|NCT00778375|EG000|Reported Event|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
10944184|NCT00778622|BG000|Baseline|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
10944185|NCT00778622|BG001|Baseline|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
10944186|NCT00778622|BG002|Baseline|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
10944187|NCT00778622|BG003|Baseline|Total|Total of all reporting groups
11177448|NCT02041104|FG001|Participant Flow|Bread Without Added Beta-glucans|"Placebo bread without added barley beta-glucans in the testing product.~Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics."
10944188|NCT00778622|FG000|Participant Flow|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to (>=)18.5 kilogram per meter squared (kg/m^2) and less than (<) 24 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks.
10944189|NCT00778622|FG001|Participant Flow|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to (>=) 24 kg/m^2 and less than (<) 28 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
10944190|NCT00778622|FG002|Participant Flow|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to (>=) 28 kg/m^2. Initial dose of Glucophage extended release (XR)on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
10944191|NCT00778622|OG000|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 .
11341674|NCT03686176|EG000|Reported Event|Virtual Reality Group (Study Group)|"In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure.~Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins."
10944192|NCT00778622|OG001|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
10944193|NCT00778622|OG002|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
10944194|NCT00778622|OG000|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
11341675|NCT03686176|EG001|Reported Event|Standard Care (Control Group)|In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.
10944195|NCT00778622|OG000|Outcome|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
10944196|NCT00778622|OG001|Outcome|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
10944197|NCT00778622|OG002|Outcome|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
10944198|NCT00778622|EG000|Reported Event|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
10944199|NCT00778622|EG001|Reported Event|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
10944200|NCT00778622|EG002|Reported Event|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
10944201|NCT00778648|BG000|Baseline|Juice Plus|
10944202|NCT00778648|BG001|Baseline|Placebo|
10944203|NCT00778648|BG002|Baseline|Total|Total of all reporting groups
10944204|NCT00778648|FG000|Participant Flow|Juice Plus|
10944205|NCT00778648|FG001|Participant Flow|Placebo|
10944206|NCT00778648|OG000|Outcome|Juice Plus|
10944207|NCT00778648|OG001|Outcome|Placebo|
10944208|NCT00778648|EG000|Reported Event|Juice Plus|
11240725|NCT02481375|OG000|Outcome|Multiple Micronutrients With Iron|"Multiple micronutrient formulations were based on the UNICEF/WHO/UNU standard formulation for pregnant and lactating women (UNIMMAP) with increased iron (from 30 mg to 60 mg elemental iron) for comparability to the iron only group (60 mg). This formulation has 15 micronutrients including iron.~Women will receive the multiple micronutrient with iron for 12 weeks.~Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine~Iron: 12-wk supplementation of iron"
10944209|NCT00778648|EG001|Reported Event|Placebo|
10944210|NCT00778817|BG000|Baseline|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
10944211|NCT00778817|FG000|Participant Flow|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
10944212|NCT00778817|OG000|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
10944213|NCT00778817|EG000|Reported Event|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
10944214|NCT00778830|BG000|Baseline|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
10944215|NCT00778830|BG001|Baseline|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
10944216|NCT00778830|BG002|Baseline|Total|Total of all reporting groups
10944217|NCT00778830|FG000|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
10944218|NCT00778830|FG001|Participant Flow|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
10944219|NCT00778830|OG000|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
10944220|NCT00778830|OG001|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
10944221|NCT00778830|EG000|Reported Event|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Irinotecan was administered intravenously at a dose of 180 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
10944222|NCT00778830|EG001|Reported Event|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Oxaliplatin was administered intravenously at a dose of 100 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
10944223|NCT00778869|BG000|Baseline|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
10944224|NCT00778869|FG000|Participant Flow|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
10944225|NCT00778869|OG000|Outcome|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54 in participants with AS.
10944226|NCT00778869|EG000|Reported Event|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
10944227|NCT00778895|BG000|Baseline|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944228|NCT00778895|BG001|Baseline|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
11192170|NCT02137512|FG000|Participant Flow|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs - a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
10944229|NCT00778895|BG002|Baseline|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944230|NCT00778895|BG003|Baseline|Total|Total of all reporting groups
10944231|NCT00778895|FG000|Participant Flow|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944232|NCT00778895|FG001|Participant Flow|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944233|NCT00778895|FG002|Participant Flow|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944234|NCT00778895|OG000|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944235|NCT00778895|OG001|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944236|NCT00778895|OG002|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944237|NCT00778895|OG000|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944238|NCT00778895|EG000|Reported Event|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10963539|NCT00872729|OG006|Outcome|Cystagon® (2.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10944239|NCT00778895|EG001|Reported Event|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944240|NCT00778895|EG002|Reported Event|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
10944241|NCT00778921|BG000|Baseline|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
10944242|NCT00778921|BG001|Baseline|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
10944243|NCT00778921|BG002|Baseline|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
10944244|NCT00778921|BG003|Baseline|Total|Total of all reporting groups
10944245|NCT00778921|FG000|Participant Flow|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
10944246|NCT00778921|FG001|Participant Flow|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
10944247|NCT00778921|FG002|Participant Flow|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
10944248|NCT00778921|OG000|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
10944249|NCT00778921|OG001|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
11177449|NCT02041104|OG000|Outcome|Bread With Added Beta-glucans|"Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.~Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics"
10944250|NCT00778921|OG002|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
10944251|NCT00778921|EG000|Reported Event|Aliskiren 300mg/ Amlodipine 10mg|Aliskiren 300mg/ Amlodipine 10mg
10944252|NCT00778921|EG001|Reported Event|Aliskiren 150mg/ Amlodipine 10mg|Aliskiren 150mg/ Amlodipine 10mg
10944253|NCT00778921|EG002|Reported Event|Amlodipine 10mg|Amlodipine 10mg
10944254|NCT00779025|BG000|Baseline|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
10944255|NCT00779025|FG000|Participant Flow|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
10944256|NCT00779025|OG000|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
10944257|NCT00779025|OG001|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
10944258|NCT00779025|EG000|Reported Event|Overall Study|
10944259|NCT00779103|BG000|Baseline|Histrelin Subcutaneous Implant (50 mg)|"Subcutaneous implant designed to deliver histrelin continously for 12 months.~Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant~Extension Safety Population (Second & Third Implant)"
10944260|NCT00779103|FG000|Participant Flow|Overall - Histrelin Subcutaneous Implant (50 mg)|"Subcutaneous implant designed to deliver histrelin continously for 12 months.~Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant"
10944261|NCT00779103|OG000|Outcome|Observed Value|
10944262|NCT00779103|OG001|Outcome|Change From Baseline|
10944263|NCT00779103|OG000|Outcome|Histrelin Subcutaneous Implant (50 mg)|"Subcutaneous implant designed to deliver histrelin continously for 12 months.~Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant~Extension Safety Population (Second & Third Implant)"
10944264|NCT00779103|OG000|Outcome|Implanted|
10944265|NCT00779103|OG001|Outcome|Removed|
10944266|NCT00779103|EG000|Reported Event|Overall - Histrelin Subcutaneous Implant (50 mg)|"Subcutaneous implant designed to deliver histrelin continously for 12 months.~Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant"
10944267|NCT00779142|BG000|Baseline|Methotrexate 25mg/ml|Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
10944268|NCT00779142|FG000|Participant Flow|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
10944269|NCT00779142|OG000|Outcome|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
10963540|NCT00872729|OG007|Outcome|RP103 (2.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10963541|NCT00872729|OG008|Outcome|Cystagon® (3 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10963542|NCT00872729|OG009|Outcome|RP103 (3 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
11177450|NCT02041104|OG001|Outcome|Bread Without Added Beta-glucans|"Placebo bread without added barley beta-glucans in the testing product.~Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics."
11177451|NCT02041104|OG000|Outcome|Bread With Added Beta-glucans|"Experimental food is bread with high amount of barley beta-glucans. Experimental bread contains approximately 3,4 % (w/w) beta-glucans. Participants will consume 6 g of beta-glucans daily (approximately 200 g of bread per day). Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glycopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Testing bread has integrated flour with high amount of barley beta-glucans (ReducholTM). Beta-glucans are concentrated in flour up to 15 % with dry milling, sieving and air classification of barley flour.~Bread with added beta-glucans: Participants will daily consume bread with high content of beta-glucans. They will approximately consume 6 g beta-glucans per day in 200 g of bread. Intervention period will be 4 week."
11177452|NCT02041104|OG001|Outcome|Bread Without Added Beta-glucans|"Placebo bread without added barley beta-glucans in testing product.~Placebo Comparator: Bread without added beta-glucans: Participants will daily consume placebo bread without any added beta-glucans (approximately 200 g per day). Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics."
11192171|NCT02137512|OG000|Outcome|2-Week Baseline Sensor-Augmented Pump|Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
10944270|NCT00779142|OG000|Outcome|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose to subjects with diabetic macular edema resistant to conventional therapies.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
10944271|NCT00779142|EG000|Reported Event|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
10944272|NCT00779155|BG000|Baseline|Inactive Resonator Device|inactive magnetic fields with placebo fields
10944273|NCT00779155|BG001|Baseline|Active Resonator Device|Active pico-tesla magnetic fields
10944274|NCT00779155|BG002|Baseline|Total|Total of all reporting groups
10944275|NCT00779155|FG000|Participant Flow|Inactive Resonator Device|inactive magnetic fields with placebo fields
10944276|NCT00779155|FG001|Participant Flow|Active Resonator Device|Active pico-tesla magnetic fields
10944277|NCT00779155|OG000|Outcome|Inactive Resonator Device|inactive magnetic fields with placebo fields
10944278|NCT00779155|OG001|Outcome|Active Resonator Device|Active pico-tesla magnetic fields
10944279|NCT00779155|EG000|Reported Event|Inactive Resonator Device|inactive magnetic fields with placebo fields
11192172|NCT02137512|OG001|Outcome|2-Week Overnight-Only Closed-Loop|Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
11341676|NCT03686176|EG002|Reported Event|Reference Group|No virtual reality and no child life specialists; no standardized or formal form of support.
10944280|NCT00779155|EG001|Reported Event|Active Resonator Device|Active pico-tesla magnetic fields
10944281|NCT00779246|BG000|Baseline|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
10944282|NCT00779246|BG001|Baseline|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
10944283|NCT00779246|BG002|Baseline|Total|Total of all reporting groups
10944284|NCT00779246|FG000|Participant Flow|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
10944285|NCT00779246|FG001|Participant Flow|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
10944286|NCT00779246|OG000|Outcome|Active Surveillance Cultures (ASC)|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
10944287|NCT00779246|OG001|Outcome|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
10944288|NCT00779246|EG000|Reported Event|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
10944289|NCT00779246|EG001|Reported Event|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
10963543|NCT00872729|OG010|Outcome|Cystagon® (4 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10944290|NCT00779259|BG000|Baseline|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
10944291|NCT00779259|FG000|Participant Flow|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
10944292|NCT00779259|OG000|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration)followed by a 4-day washout period.
10944293|NCT00779259|OG001|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11.
10944294|NCT00779259|OG002|Outcome|Theophylline in the Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
10944295|NCT00779259|OG003|Outcome|Quinine in the Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
10944296|NCT00779259|OG000|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
10944297|NCT00779259|OG001|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
10944298|NCT00779259|OG002|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
10944299|NCT00779259|OG003|Outcome|Quinine in Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
10944300|NCT00779259|OG001|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
10944301|NCT00779259|OG000|Outcome|1 Hour Before Morning Dose of Quinine on Study Day 11|measured 1 hour prior to the morning dose of Quinine on study Day 11
10944302|NCT00779259|OG001|Outcome|4 Hours After Morning Dose of Quinine on Study Day 11|measured 4 hours after the morning dose of quinine
10944303|NCT00779259|OG000|Outcome|1 Hour Before Co-Administered Dose of Theophylline/Quinine|measured 1 hour prior to the 7 am co-administered dose of theophylline and quinine
10944304|NCT00779259|OG001|Outcome|4 Hours After Co-Administered Dose of Theophylline/Quinine|measured 4 hours after the 7 am co-administered dose of theophylline and quinine
10944305|NCT00779259|EG000|Reported Event|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml)followed by a 4 day washout period
10944306|NCT00779259|EG001|Reported Event|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
10944307|NCT00779259|EG002|Reported Event|Theophylline Co-administered With Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml) and quinine sulfate (2 x 324 mg capsules).
10944308|NCT00779285|BG000|Baseline|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
10944309|NCT00779285|FG000|Participant Flow|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
10944310|NCT00779285|OG000|Outcome|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
10944311|NCT00779285|EG000|Reported Event|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
10944312|NCT00779311|BG000|Baseline|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
10944313|NCT00779311|BG001|Baseline|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
10944314|NCT00779311|BG002|Baseline|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
10944315|NCT00779311|BG003|Baseline|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
10944316|NCT00779311|BG004|Baseline|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
10944317|NCT00779311|BG005|Baseline|Total|Total of all reporting groups
10963544|NCT00872729|OG011|Outcome|RP103 (4 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10944318|NCT00779311|FG000|Participant Flow|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
10944319|NCT00779311|FG001|Participant Flow|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
10944320|NCT00779311|FG002|Participant Flow|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
10944321|NCT00779311|FG003|Participant Flow|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
10944322|NCT00779311|FG004|Participant Flow|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
10944323|NCT00779311|OG000|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
10944324|NCT00779311|OG001|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
10944325|NCT00779311|OG002|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
10944326|NCT00779311|OG003|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
10944327|NCT00779311|OG004|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
10944328|NCT00779311|EG000|Reported Event|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
10944329|NCT00779311|EG001|Reported Event|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
10944330|NCT00779311|EG002|Reported Event|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
10944331|NCT00779311|EG003|Reported Event|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
10944332|NCT00779311|EG004|Reported Event|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
10944333|NCT00779324|BG000|Baseline|Amantadine|"Amantadine 100 mg every morning and Noon~Amantadine Hydrochloride: 100 mg every morning and noon"
10944334|NCT00779324|BG001|Baseline|Placebo|"Placebo tablets~Placebo: one placebo tablet every morning and 12 Noon"
10944335|NCT00779324|BG002|Baseline|Total|Total of all reporting groups
10944336|NCT00779324|FG000|Participant Flow|Amantadine|"Amantadine 100 mg every morning and Noon~Amantadine Hydrochloride: 100 mg every morning and noon"
10944337|NCT00779324|FG001|Participant Flow|Placebo|"Placebo tablets~Placebo: one placebo tablet every morning and 12 Noon"
10944338|NCT00779324|OG000|Outcome|Amantadine|"Amantadine 100 mg every morning and Noon~Amantadine Hydrochloride: 100 mg every morning and noon"
10944339|NCT00779324|OG001|Outcome|Placebo|"Placebo tablets~Placebo: one placebo tablet every morning and 12 Noon"
10944340|NCT00779324|EG000|Reported Event|Amantadine|"Amantadine 100 mg every morning and Noon~Amantadine Hydrochloride: 100 mg every morning and noon"
10944341|NCT00779324|EG001|Reported Event|Placebo|"Placebo tablets~Placebo: one placebo tablet every morning and 12 Noon"
10944342|NCT00779402|BG000|Baseline|Sipuleucel-T|"Provenge~Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF"
10944343|NCT00779402|BG001|Baseline|Control|"Control~Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen"
10944344|NCT00779402|BG002|Baseline|Total|Total of all reporting groups
10944345|NCT00779402|FG000|Participant Flow|Sipuleucel-T|"Provenge~Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF"
10944346|NCT00779402|FG001|Participant Flow|Control|"Control~Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen"
10944347|NCT00779402|OG000|Outcome|Sipuleucel-T|Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
10944348|NCT00779402|OG001|Outcome|Control|Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions.
10944349|NCT00779402|EG000|Reported Event|Sipuleucel-T|"Provenge~Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF"
10944350|NCT00779402|EG001|Reported Event|Control|"Control~Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen"
10944351|NCT00779467|BG000|Baseline|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944352|NCT00779467|BG001|Baseline|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944353|NCT00779467|BG002|Baseline|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944354|NCT00779467|BG003|Baseline|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
10944355|NCT00779467|BG004|Baseline|Total|Total of all reporting groups
10944356|NCT00779467|FG000|Participant Flow|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944357|NCT00779467|FG001|Participant Flow|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944358|NCT00779467|FG002|Participant Flow|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
11177453|NCT02041104|EG000|Reported Event|Bread With Added Beta-glucans|"Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.~Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics"
10944359|NCT00779467|FG003|Participant Flow|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
10944360|NCT00779467|OG000|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944361|NCT00779467|OG001|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944362|NCT00779467|OG002|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944363|NCT00779467|OG003|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
10944364|NCT00779467|EG000|Reported Event|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944365|NCT00779467|EG001|Reported Event|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944366|NCT00779467|EG002|Reported Event|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
10944367|NCT00779467|EG003|Reported Event|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
11177454|NCT02041104|EG001|Reported Event|Bread Without Added Beta-glucans|"Placebo bread without added barley beta-glucans in the testing product.~Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics."
11177455|NCT02041221|BG000|Baseline|S0597 Dose 1|"Subjects will be administered with S0597~S0597: The subjects will receive S0597.~Placebo"
10944368|NCT00779506|BG000|Baseline|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
10944369|NCT00779506|FG000|Participant Flow|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
10944370|NCT00779506|OG000|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
10944371|NCT00779506|EG000|Reported Event|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
10944372|NCT00779558|BG000|Baseline|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
10944373|NCT00779558|BG001|Baseline|Placebo|Placebo - normal saline infusion
10944374|NCT00779558|BG002|Baseline|Total|Total of all reporting groups
10944375|NCT00779558|FG000|Participant Flow|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
10944376|NCT00779558|FG001|Participant Flow|Placebo|Placebo - normal saline infusion
10944377|NCT00779558|OG000|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
10944378|NCT00779558|OG001|Outcome|Placebo|Placebo - normal saline infusion
10944379|NCT00779558|EG000|Reported Event|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
10944380|NCT00779558|EG001|Reported Event|Placebo|Placebo - normal saline infusion
10944381|NCT00779584|BG000|Baseline|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944382|NCT00779584|BG001|Baseline|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944383|NCT00779584|BG002|Baseline|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944384|NCT00779584|BG003|Baseline|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944385|NCT00779584|BG004|Baseline|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944386|NCT00779584|BG005|Baseline|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944387|NCT00779584|BG006|Baseline|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944388|NCT00779584|BG007|Baseline|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944389|NCT00779584|BG008|Baseline|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944390|NCT00779584|BG009|Baseline|Total|Total of all reporting groups
10944391|NCT00779584|FG000|Participant Flow|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an intravenous (IV) infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944392|NCT00779584|FG001|Participant Flow|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944393|NCT00779584|FG002|Participant Flow|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944394|NCT00779584|FG003|Participant Flow|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944395|NCT00779584|FG004|Participant Flow|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944396|NCT00779584|FG005|Participant Flow|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944397|NCT00779584|FG006|Participant Flow|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944398|NCT00779584|FG007|Participant Flow|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944399|NCT00779584|FG008|Participant Flow|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944400|NCT00779584|OG000|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944401|NCT00779584|OG001|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944402|NCT00779584|OG002|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944403|NCT00779584|OG003|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944404|NCT00779584|OG004|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944405|NCT00779584|OG005|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944406|NCT00779584|OG006|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944407|NCT00779584|OG007|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944408|NCT00779584|OG008|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944409|NCT00779584|EG000|Reported Event|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944410|NCT00779584|EG001|Reported Event|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944411|NCT00779584|EG002|Reported Event|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944412|NCT00779584|EG003|Reported Event|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944413|NCT00779584|EG004|Reported Event|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944414|NCT00779584|EG005|Reported Event|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944415|NCT00779584|EG006|Reported Event|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944416|NCT00779584|EG007|Reported Event|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944417|NCT00779584|EG008|Reported Event|MK-8776 200mg Flat Dose+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
10944418|NCT00779675|BG000|Baseline|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
10944419|NCT00779675|FG000|Participant Flow|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
10944420|NCT00779675|OG000|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
10944421|NCT00779675|OG000|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries).
10944422|NCT00779675|OG000|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2,6, and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries)
10944423|NCT00779675|OG000|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Week 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characterisitics (SPC; European Union), or local labelling (for all other countries).
10944424|NCT00779675|OG000|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
10944425|NCT00779675|EG000|Reported Event|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
10963545|NCT00872729|OG012|Outcome|Cystagon® (6 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10963546|NCT00872729|OG013|Outcome|RP103 (6 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10963547|NCT00872729|OG014|Outcome|Cystagon® (8 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10963548|NCT00872729|OG015|Outcome|RP103 (8 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10963549|NCT00872729|OG016|Outcome|Cystagon® (10 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10963550|NCT00872729|OG017|Outcome|RP103 (10 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10963551|NCT00872729|OG018|Outcome|Cystagon® (12 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
10963552|NCT00872729|OG019|Outcome|RP103 (12 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
10963553|NCT00872729|EG000|Reported Event|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg;
10963554|NCT00872729|EG001|Reported Event|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg
10963555|NCT00872833|BG000|Baseline|Overall|Both cohorts combined
10963556|NCT00872833|FG000|Participant Flow|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
10963557|NCT00872833|FG001|Participant Flow|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
10963558|NCT00872833|OG000|Outcome|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
10963559|NCT00872833|OG001|Outcome|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
10963560|NCT00872833|OG000|Outcome|<= 14 Days|Subjects with transfusion cycles of 14 days or less
10963561|NCT00872833|OG001|Outcome|15 - 21 Days|Subjects with transfusion cycles between 15 and 21 days
10963562|NCT00872833|OG002|Outcome|22 - 28 Days|Subjects with transfusion cycles between 22 and 28 days
10963563|NCT00872833|OG003|Outcome|> 28 Days|Subjects with transfusion cycles greater than 28 days
10963564|NCT00872833|EG000|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected as part of this observational study.
10963565|NCT00872898|BG000|Baseline|Part One - Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
10963566|NCT00872898|BG001|Baseline|Part Two - Placebo|Once daily oral administration of placebo for 12 weeks.
10963567|NCT00872898|BG002|Baseline|Part Two - Memantine|Once daily oral administration of memantine extended release for 12 weeks. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.
10963568|NCT00872898|BG003|Baseline|Total|Total of all reporting groups
10963569|NCT00872898|FG000|Participant Flow|Placebo|Once daily, oral administration of placebo for 12 weeks.
10963570|NCT00872898|FG001|Participant Flow|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
10963571|NCT00872898|OG000|Outcome|Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
10963572|NCT00872898|OG000|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
10963573|NCT00872898|OG001|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
10963574|NCT00872898|OG000|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
10963575|NCT00872898|EG000|Reported Event|Placebo - Part Two, Double-Blind Treatment|Once daily oral administration of placebo for 12 weeks
10963576|NCT00872898|EG001|Reported Event|Memantine - Part Two, Double-Blind Treatment|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups."
10963577|NCT00872898|EG002|Reported Event|Memantine - Part One, Open Label Treatment|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
10963578|NCT00872989|BG000|Baseline|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
10963579|NCT00872989|BG001|Baseline|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
10963580|NCT00872989|BG002|Baseline|Total|Total of all reporting groups
10963581|NCT00872989|FG000|Participant Flow|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
10963582|NCT00872989|FG001|Participant Flow|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
11177456|NCT02041221|BG001|Baseline|S0597 Dose 2|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
11177457|NCT02041221|BG002|Baseline|S0597 Dose 3|
10944426|NCT00779701|BG000|Baseline|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
10944427|NCT00779701|FG000|Participant Flow|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
10944428|NCT00779701|OG000|Outcome|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
10944429|NCT00779701|EG000|Reported Event|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
10944430|NCT00779766|BG000|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10944431|NCT00779766|BG001|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10944432|NCT00779766|BG002|Baseline|Total|Total of all reporting groups
10944433|NCT00779766|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10944434|NCT00779766|FG001|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10944435|NCT00779766|OG000|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10944436|NCT00779766|OG001|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10944437|NCT00779766|OG001|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
10944438|NCT00779766|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10944439|NCT00779766|EG001|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
10944440|NCT00779779|BG000|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
10944441|NCT00779779|FG000|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
10944442|NCT00779779|OG000|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
10944443|NCT00779779|EG000|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
10944444|NCT00779857|BG000|Baseline|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
10944445|NCT00779857|FG000|Participant Flow|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
10944446|NCT00779857|OG000|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
10944447|NCT00779857|EG000|Reported Event|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
10944448|NCT00779870|BG000|Baseline|Healthy|Healthy Participant
10944449|NCT00779870|BG001|Baseline|Non-severe Asthma|Patients with mild and moderate asthma
10944450|NCT00779870|BG002|Baseline|Severe Asthma|Patients with severe asthma
10944451|NCT00779870|BG003|Baseline|Total|Total of all reporting groups
10944452|NCT00779870|FG000|Participant Flow|Healthy|Healthy Participant
10944453|NCT00779870|FG001|Participant Flow|Non-severe Asthma|Patients with mild and moderate asthma
10944454|NCT00779870|FG002|Participant Flow|Severe Asthma|Patients with severe asthma
10944455|NCT00779870|OG000|Outcome|Healthy|Healthy Participant
10944456|NCT00779870|OG001|Outcome|Non-severe Asthma|Patients with mild and moderate asthma
10944457|NCT00779870|OG002|Outcome|Severe Asthma|Patients with severe asthma
10944458|NCT00779870|EG000|Reported Event|Healthy|Healthy Participant
10944459|NCT00779870|EG001|Reported Event|Non-severe Asthma|Patients with mild and moderate asthma
10944460|NCT00779870|EG002|Reported Event|Severe Asthma|Patients with severe asthma
10944461|NCT00779909|BG000|Baseline|1-Placebo|placebo oral supplementation once per day for 12 weeks
10944462|NCT00779909|BG001|Baseline|2-Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
10944463|NCT00779909|BG002|Baseline|3-Vitamin D3, 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
10944464|NCT00779909|BG003|Baseline|4-Vitamin D3, 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
10944465|NCT00779909|BG004|Baseline|Total|Total of all reporting groups
10944466|NCT00779909|FG000|Participant Flow|1- Placebo|placebo oral supplementation once per day for 12 weeks
10944467|NCT00779909|FG001|Participant Flow|2- Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
10944468|NCT00779909|FG002|Participant Flow|3- Vitamin D3 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
11177458|NCT02041221|BG003|Baseline|S0597 Dose 4|
10944469|NCT00779909|FG003|Participant Flow|4- Vitamin D3 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
10944470|NCT00779909|OG000|Outcome|1- Placebo|placebo oral supplementation once per day for 12 weeks
10944471|NCT00779909|OG001|Outcome|2- Vitamin D3, 500 IU|vitamin D3: oral supplementation once per day for 12 weeks
10944472|NCT00779909|OG002|Outcome|3.Vitamin D3, 2500 IU|vitamin D3: oral supplementation once per day for 12 weeks
10944473|NCT00779909|OG003|Outcome|4- Vitamin D3 5000 IU|vitamin D3: oral supplementation once per day for 12 weeks
10944474|NCT00779909|OG001|Outcome|2- Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
10944475|NCT00779909|OG002|Outcome|3- Vitamin D3 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
10944476|NCT00779909|OG003|Outcome|4- Vitamin D3 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
10944477|NCT00779909|OG000|Outcome|1-Placebo|placebo oral supplementation once per day for 12 weeks
10944478|NCT00779909|OG001|Outcome|2-Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
10944479|NCT00779909|OG002|Outcome|3-Vitamin D3, 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
10944480|NCT00779909|OG003|Outcome|4-Vitamin D3, 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
10944481|NCT00779909|EG000|Reported Event|1- Placebo|placebo oral supplementation once per day for 12 weeks
10944482|NCT00779909|EG001|Reported Event|2- Vitamin D3, 500 IU|vitamin D3, 500 IU capsule once per day for 12 weeks
10944483|NCT00779909|EG002|Reported Event|3- Vitamin D3 2500 IU|vitamin D3, 2500 IU capsule once per day for 12 weeks
10944484|NCT00779909|EG003|Reported Event|4- Vitamin D3 5000 IU|vitamin D3, 5000 IU capsule once per day for 12 weeks
10944485|NCT00780026|BG000|Baseline|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
10944486|NCT00780026|BG001|Baseline|Standard of Care Control|standard of care insulin dosing
10944487|NCT00780026|BG002|Baseline|Total|Total of all reporting groups
10944488|NCT00780026|FG000|Participant Flow|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
10944489|NCT00780026|FG001|Participant Flow|Standard of Care Control|standard of care insulin dosing
10944490|NCT00780026|OG000|Outcome|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
10944491|NCT00780026|OG001|Outcome|Standard of Care Control|standard of care insulin dosing
10944492|NCT00780026|EG000|Reported Event|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
10944493|NCT00780026|EG001|Reported Event|Standard of Care Control|standard of care insulin dosing
10944494|NCT00780143|BG000|Baseline|Aplidin®|"Plitidepsin in combination with Cytarabine in Patients With Relapsed/Refractory Leukemia~Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days."
10944495|NCT00780143|FG000|Participant Flow|Aplidin®|"Plitidepsin in combination with Cytarabine in Patients With Relapsed/Refractory Leukemia~Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days."
10944496|NCT00780143|OG000|Outcome|Aplidin®|"Plitidepsin in combination with Cytarabine in Patients With Relapsed/Refractory Leukemia~Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days."
10944497|NCT00780143|EG000|Reported Event|Aplidin®|"Plitidepsin in combination with Cytarabine~Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days."
10944498|NCT00780208|BG000|Baseline|Daytrana (Methylphenidate Patch)|"Methylphenidate patch~Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability."
10944499|NCT00780208|FG000|Participant Flow|Daytrana (Methylphenidate Patch)|"Methylphenidate patch~Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability."
10944500|NCT00780208|OG000|Outcome|Daytrana (Methylphenidate Patch)|"Methylphenidate patch~Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability."
10944501|NCT00780208|EG000|Reported Event|Daytrana (Methylphenidate Patch)|"Methylphenidate patch~Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability."
10963583|NCT00872989|OG000|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
11177459|NCT02041221|BG004|Baseline|S0597 Dose 5|
11177460|NCT02041221|BG005|Baseline|Placebo|
11177461|NCT02041221|BG006|Baseline|Total|Total of all reporting groups
11177462|NCT02041221|FG000|Participant Flow|S0597 Dose 1|Subjects will be administered with SPARC1316 dose 1
10944502|NCT00780234|BG000|Baseline|Arm 1: Pioglitazone|"Current or former smokers receive 6 months of treatment with pioglitazone~fluorescence bronchoscopy: examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.~quantitative high resolution CT scan: High resolution CT scan of the chest~PIOGLITAZONE VS. PLACEBO 30 mg: Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator-~activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials."
10944503|NCT00780234|BG001|Baseline|Arm 2: Placebo|"Current or former smokers receive 6 months of treatment with placebo~fluorescence bronchoscopy: examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.~quantitative high resolution CT scan: High resolution CT scan of the chest"
10944504|NCT00780234|BG002|Baseline|Total|Total of all reporting groups
10944505|NCT00780234|FG000|Participant Flow|Arm 1: Pioglitazone|"Current or former smokers receive 6 months of treatment with pioglitazone.~fluorescence bronchoscopy: examination of the central airways with a bronchoscope. Both white light and fluorescent light.~quantitative high resolution CT scan: High resolution chest CT scan~PIOGLITAZONE VS. PLACEBO 30 mg: Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator- activated receptor-gamma agonist."
10944506|NCT00780234|FG001|Participant Flow|Arm 2: Placebo|"Current or former smokers receive 6 months of treatment with placebo~fluorescence bronchoscopy: examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.~quantitative high resolution CT scan: High resolution CT scan of the chest"
10944507|NCT00780234|OG000|Outcome|Arm 1: Pioglitazone|"Current or former smokers receive 6 months of treatment with pioglitazone~fluorescence bronchoscopy: examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.~quantitative high resolution CT scan: High resolution CT scan of the chest~PIOGLITAZONE VS. PLACEBO 30 mg: Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator-~activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials."
10944508|NCT00780234|OG001|Outcome|Arm 2: Placebo|"Current or former smokers receive 6 months of treatment with placebo~fluorescence bronchoscopy: examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.~quantitative high resolution CT scan: High resolution CT scan of the chest"
10944509|NCT00780234|EG000|Reported Event|Arm 1: Pioglitazone|"Current or former smokers receive 6 months of treatment with pioglitazone~fluorescence bronchoscopy: examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.~quantitative high resolution CT scan: High resolution CT scan of the chest~PIOGLITAZONE VS. PLACEBO 30 mg: Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator-~activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials."
11177463|NCT02041221|FG001|Participant Flow|S0597 Dose 2|Subjects will receive SPARC1316 dose 2
11177464|NCT02041221|FG002|Participant Flow|S0597 Dose 3|Subjects will receive SPARC1316 dose 3
11177465|NCT02041221|FG003|Participant Flow|S0597 Dose 4|Subjects will receive SPARC1316 dose 4
11177466|NCT02041221|FG004|Participant Flow|S0597 Dose 5|Subjects will receive SPARC1316 dose 5
11177467|NCT02041221|FG005|Participant Flow|Placebo|Subjects will receive placebo
11177468|NCT02041221|OG000|Outcome|S0597 Dose 1|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
11177469|NCT02041221|OG001|Outcome|S0597 Dose 2|
11177470|NCT02041221|OG002|Outcome|S0597 Dose 3|
11177471|NCT02041221|OG003|Outcome|S0597 Dose 4|
11177472|NCT02041221|OG004|Outcome|S0597 Dose 5|
11177473|NCT02041221|OG005|Outcome|Placebo|
11177474|NCT02041221|EG000|Reported Event|S0597 Dose 1|"Subjects will be administered with S0597~S0597: The subjects will receive S0597.~Placebo"
11177475|NCT02041221|EG001|Reported Event|S0597 Dose 2|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
11177476|NCT02041221|EG002|Reported Event|S0597 Dose 3|
11177477|NCT02041221|EG003|Reported Event|S0597 Dose 4|
11177478|NCT02041221|EG004|Reported Event|S0597 Dose 5|
11177479|NCT02041221|EG005|Reported Event|Placebo|
11177480|NCT02041286|BG000|Baseline|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
11177481|NCT02041286|FG000|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
10944510|NCT00780234|EG001|Reported Event|Arm 2: Placebo|"Current or former smokers receive 6 months of treatment with placebo~fluorescence bronchoscopy: examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.~quantitative high resolution CT scan: High resolution CT scan of the chest"
10944511|NCT00780273|BG000|Baseline|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.~A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.~After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
10944512|NCT00780273|FG000|Participant Flow|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.~A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.~After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
10944513|NCT00780273|OG000|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
10944514|NCT00780273|OG001|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
10944515|NCT00780273|EG000|Reported Event|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study."
10944516|NCT00780338|BG000|Baseline|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
10944517|NCT00780338|BG001|Baseline|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
10944518|NCT00780338|BG002|Baseline|Total|Total of all reporting groups
10944519|NCT00780338|FG000|Participant Flow|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
10944520|NCT00780338|FG001|Participant Flow|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
10944521|NCT00780338|OG000|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
10944522|NCT00780338|OG001|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
10944523|NCT00780338|OG000|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
10944524|NCT00780338|OG001|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
10944525|NCT00780338|OG000|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
10944526|NCT00780338|OG001|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
10944527|NCT00780338|EG000|Reported Event|AGTO|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
10944528|NCT00780338|EG001|Reported Event|Control|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
10944529|NCT00780416|BG000|Baseline|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944530|NCT00780416|BG001|Baseline|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
10944531|NCT00780416|BG002|Baseline|Total|Total of all reporting groups
10944532|NCT00780416|FG000|Participant Flow|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944533|NCT00780416|FG001|Participant Flow|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
10944534|NCT00780416|OG000|Outcome|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944535|NCT00780416|OG001|Outcome|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
10944536|NCT00780416|EG000|Reported Event|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944537|NCT00780416|EG001|Reported Event|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
10944538|NCT00780442|BG000|Baseline|D-cycloserine|Participants received DCS prior to cocaine cue exposure sessions.
10944539|NCT00780442|BG001|Baseline|Placebo|Participants received placebo prior to cocaine cue exposure sessions.
10944540|NCT00780442|BG002|Baseline|Total|Total of all reporting groups
10944541|NCT00780442|FG000|Participant Flow|D-cycloserine|Participants received DCS prior to cocaine cue exposure sessions.
10944542|NCT00780442|FG001|Participant Flow|Placebo|Participants received placebo prior to cocaine cue exposure sessions.
10944543|NCT00780442|OG000|Outcome|D-cycloserine|Participants received DCS prior to cocaine cue exposure sessions.
10944544|NCT00780442|OG001|Outcome|Placebo|Participants received placebo prior to cocaine cue exposure sessions.
10944545|NCT00780442|EG000|Reported Event|D-cycloserine|Participants received DCS prior to cocaine cue exposure sessions.
10944546|NCT00780442|EG001|Reported Event|Placebo|Participants received placebo prior to cocaine cue exposure sessions.
10944547|NCT00780494|BG000|Baseline|Bevacizumab+ Carboplatin +Capecitabine|Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
10944548|NCT00780494|FG000|Participant Flow|Bevacizumab+ Carboplatin +Capecitabine|Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
10944549|NCT00780494|OG000|Outcome|Bevacizumab+ Carboplatin +Capecitabine|Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
10944550|NCT00780494|EG000|Reported Event|Bevacizumab+ Carboplatin +Capecitabine|Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
10944551|NCT00780559|BG000|Baseline|Tailored Diet and Physical Activity|Subjects will receive an individually tailored diet and physical activity enhancement program
10944552|NCT00780559|BG001|Baseline|Standard of Care|Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
10944553|NCT00780559|BG002|Baseline|Total|Total of all reporting groups
10944554|NCT00780559|FG000|Participant Flow|Tailored Diet and Physical Activity|Tailored Diet and Physical Activity: Subjects will receive an individually tailored diet and physical activity enhancement program
10944555|NCT00780559|FG001|Participant Flow|Standard of Care|Standard of Care: Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
10944556|NCT00780559|OG000|Outcome|Tailored Diet and Physical Activity|Subjects will receive an individually tailored diet and physical activity enhancement program
10944557|NCT00780559|OG001|Outcome|Standard of Care|Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
10944558|NCT00780559|OG000|Outcome|Tailored Diet and Physical Activity|Tailored Diet and Physical Activity: Subjects will receive an individually tailored diet and physical activity enhancement program
10944559|NCT00780559|OG001|Outcome|Standard of Care|Standard of Care: Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
10944560|NCT00780559|EG000|Reported Event|Tailored Diet and Physical Activity|Subjects will receive an individually tailored diet and physical activity enhancement program
10944561|NCT00780559|EG001|Reported Event|Standard of Care|Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
10944562|NCT00780572|BG000|Baseline|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
10944563|NCT00780572|BG001|Baseline|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
10944564|NCT00780572|BG002|Baseline|Total|Total of all reporting groups
10944565|NCT00780572|FG000|Participant Flow|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
10944566|NCT00780572|FG001|Participant Flow|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
10944567|NCT00780572|OG000|Outcome|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
10944568|NCT00780572|OG001|Outcome|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
10944569|NCT00780572|EG000|Reported Event|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
11177482|NCT02041286|OG000|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
10944570|NCT00780572|EG001|Reported Event|Arm 2: Control/No Alert|The second arm is the control. Alerts will not be displayed for these patients.
10944571|NCT00780676|BG000|Baseline|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944572|NCT00780676|BG001|Baseline|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944573|NCT00780676|BG002|Baseline|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944574|NCT00780676|BG003|Baseline|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (either MEK pathway activity predictor positive or MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
10944575|NCT00780676|BG004|Baseline|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
10944576|NCT00780676|BG005|Baseline|Total|Total of all reporting groups
10944577|NCT00780676|FG000|Participant Flow|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944578|NCT00780676|FG001|Participant Flow|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944579|NCT00780676|FG002|Participant Flow|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944580|NCT00780676|FG003|Participant Flow|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway activity predictor positive) receive selumetinib 75 mg by mouth twice daily (BID).
10944581|NCT00780676|FG004|Participant Flow|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
10944582|NCT00780676|OG000|Outcome|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944583|NCT00780676|OG001|Outcome|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944584|NCT00780676|OG002|Outcome|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
10944585|NCT00780676|EG000|Reported Event|Dasatinib 100 mg|Participants with one of 3 predictive gene signatures (dasatinib sensitivity signature, SRC pathway activity signature and dasatinib target index) received Dasatinib 100 mg orally daily.
10944586|NCT00780715|BG000|Baseline|Gliclazide MR|Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
10944587|NCT00780715|BG001|Baseline|Sitagliptin|Sitagliptin: Sitagliptin 100mg daily for 6 months
10944588|NCT00780715|BG002|Baseline|Pioglitazone|Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
11177483|NCT02041286|OG000|Outcome|Intended Users of the Monitoring System|Study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
11177484|NCT02041286|OG000|Outcome|Intended Users of the Monitoring System|Study staff test subject capillary blood and BG results are compared to reference method results obtained from subject capillary plasma.
11192173|NCT02137512|OG002|Outcome|2-Week 24/7 Closed-Loop|24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
10944589|NCT00780715|BG003|Baseline|Metformin|Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
10944590|NCT00780715|BG004|Baseline|Total|Total of all reporting groups
10944591|NCT00780715|FG000|Participant Flow|Gliclazide MR|Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
10944592|NCT00780715|FG001|Participant Flow|Sitagliptin|Sitagliptin: Sitagliptin 100mg daily for 6 months
10944593|NCT00780715|FG002|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
10944594|NCT00780715|FG003|Participant Flow|Metformin|Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
10944595|NCT00780715|OG000|Outcome|Gliclazide MR|Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
10944596|NCT00780715|OG001|Outcome|Sitagliptin|Sitagliptin: Sitagliptin 100mg daily for 6 months
10944597|NCT00780715|OG002|Outcome|Pioglitazone|Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
10944598|NCT00780715|OG003|Outcome|Metformin|Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
10944599|NCT00780715|EG000|Reported Event|Gliclazide MR|Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
10944600|NCT00780715|EG001|Reported Event|Sitagliptin|Sitagliptin: Sitagliptin 100mg daily for 6 months
10944601|NCT00780715|EG002|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
10944602|NCT00780715|EG003|Reported Event|Metformin|Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
10944603|NCT00780741|BG000|Baseline|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
10944604|NCT00780741|BG001|Baseline|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
10944605|NCT00780741|BG002|Baseline|Total|Total of all reporting groups
10944606|NCT00780741|FG000|Participant Flow|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office setting using topical anesthesia and infant restraint. Probing to be performed either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
10944607|NCT00780741|FG001|Participant Flow|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a surgical facility under general anesthesia within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
10944608|NCT00780741|OG000|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
10944609|NCT00780741|OG001|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
10944610|NCT00780741|OG000|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist.
10944611|NCT00780741|EG000|Reported Event|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
10944612|NCT00780741|EG001|Reported Event|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
10944613|NCT00780910|BG000|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944614|NCT00780910|FG000|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944615|NCT00780910|OG000|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944616|NCT00780910|EG000|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944617|NCT00780962|BG000|Baseline|N-Acetycysteine Group|Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.
10944618|NCT00780962|BG001|Baseline|0.9% Sodium-chloride Group|Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
10944619|NCT00780962|BG002|Baseline|Total|Total of all reporting groups
10944620|NCT00780962|FG000|Participant Flow|N-Acetycysteine Group|Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.
10944621|NCT00780962|FG001|Participant Flow|0.9% Sodium-chloride Group|Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
10944622|NCT00780962|OG000|Outcome|N-Acetycysteine Group|Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.
10944623|NCT00780962|OG001|Outcome|0.9% Sodium-chloride Group|Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
10944624|NCT00780962|EG000|Reported Event|N-Acetycysteine Group|Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.
10944625|NCT00780962|EG001|Reported Event|0.9% Sodium-chloride Group|Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
10944626|NCT00780975|BG000|Baseline|Aplidin®|"Aplidin (Plitidepsin)~Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks."
10944627|NCT00780975|FG000|Participant Flow|Aplidin®|"Aplidin (Plitidepsin)~Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks."
10944628|NCT00780975|OG000|Outcome|Aplidin®|"Aplidin (Plitidepsin)~Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks."
10944629|NCT00780975|EG000|Reported Event|Aplidin®|"Aplidin (Plitidepsin)~Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks."
10944630|NCT00781079|BG000|Baseline|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
10944631|NCT00781079|BG001|Baseline|Care as Usual|Care as usual
10944632|NCT00781079|BG002|Baseline|Total|Total of all reporting groups
10944633|NCT00781079|FG000|Participant Flow|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
10944634|NCT00781079|FG001|Participant Flow|Care as Usual|Care as usual
10944635|NCT00781079|OG000|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
10944636|NCT00781079|OG001|Outcome|Care as Usual|Care as usual on the case management teams
10944637|NCT00781079|EG000|Reported Event|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
10944638|NCT00781079|EG001|Reported Event|Case as Usual|Care as usual on case management teams
10944639|NCT00781274|BG000|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944640|NCT00781274|FG000|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944641|NCT00781274|OG000|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944642|NCT00781274|EG000|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
10944643|NCT00781326|BG000|Baseline|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
10944644|NCT00781326|FG000|Participant Flow|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
10944645|NCT00781326|OG000|Outcome|Open Label Antidepressant|"In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.~Nimodipine: Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.~Placebo: Placebo will be given in doses matching those of nimodipine."
10944646|NCT00781326|EG000|Reported Event|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
10944647|NCT00781365|BG000|Baseline|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
10944648|NCT00781365|BG001|Baseline|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
10944649|NCT00781365|BG002|Baseline|Total|Total of all reporting groups
11341677|NCT03687125|BG000|Baseline|Tinostamustine 180 mg/m^2|Participants received single dose of tinostamustine 180 mg/m^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.
10944650|NCT00781365|FG000|Participant Flow|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
10944651|NCT00781365|FG001|Participant Flow|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
10944652|NCT00781365|OG000|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
10944653|NCT00781365|OG001|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
10944654|NCT00781365|EG000|Reported Event|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
10944655|NCT00781365|EG001|Reported Event|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
10944656|NCT00781391|BG000|Baseline|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
10944657|NCT00781391|BG001|Baseline|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
10944658|NCT00781391|BG002|Baseline|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
10944659|NCT00781391|BG003|Baseline|Total|Total of all reporting groups
10944660|NCT00781391|FG000|Participant Flow|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
10944661|NCT00781391|FG001|Participant Flow|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
10944662|NCT00781391|FG002|Participant Flow|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
10944663|NCT00781391|OG000|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
10944664|NCT00781391|OG001|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
10944665|NCT00781391|OG002|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
10944666|NCT00781391|EG000|Reported Event|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
10944667|NCT00781391|EG001|Reported Event|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
10944668|NCT00781391|EG002|Reported Event|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
10944669|NCT00781456|BG000|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
10944670|NCT00781456|BG001|Baseline|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
10944671|NCT00781456|BG002|Baseline|Total|Total of all reporting groups
10944672|NCT00781456|FG000|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
10944673|NCT00781456|FG001|Participant Flow|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
10944674|NCT00781456|OG000|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
11177485|NCT02041286|EG000|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
11177486|NCT02041299|BG000|Baseline|Deferiprone|Number of patients who received deferiprone
11177487|NCT02041299|BG001|Baseline|Deferoxamine|Number of patients who received deferoxamine
10944675|NCT00781456|OG001|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
10944676|NCT00781456|EG000|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
10944677|NCT00781456|EG001|Reported Event|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
10944678|NCT00781508|BG000|Baseline|Sildenafil First Placebo Second|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
10944679|NCT00781508|BG001|Baseline|Placebo First Sildenafil Second|Effect of placebo on left ventricular filling pressures in patients with heart failure
10944680|NCT00781508|BG002|Baseline|Total|Total of all reporting groups
10944681|NCT00781508|FG000|Participant Flow|Sildenafil Then Placebo|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
10944682|NCT00781508|FG001|Participant Flow|Placebo Then Sildenafil|Effect of Sildenafil on left ventricular function
11177488|NCT02041299|BG002|Baseline|Total|Total of all reporting groups
11177489|NCT02041299|FG000|Participant Flow|Deferiprone|Patients randomized to the deferiprone arm (daily dosage of either 75 or 99 mg/kg divided into 3 equal doses, taken orally)
11177490|NCT02041299|FG001|Participant Flow|Deferoxamine|Patients randomized to the deferoxamine arm (either 20 mg/kg or up to 40 mg/kg for children, either 40 or 50 mg/kg for adults, administered as a subcutaneous infusion over 8-12 hours, 5 to 7 days a week)
10944683|NCT00781508|OG000|Outcome|Sildenafil First Then Placebo|sildenafil 50 mg administered orally, placebo administered orally 48 hrs later
10944684|NCT00781508|OG001|Outcome|Placebo First Then Sildenafil|placebo administered orally, then sildenafil orally 48 hrs later
10944685|NCT00781508|OG000|Outcome|Sildenafil First Then Placebo|Sildenafil 50 mg orally, placebo orally 2 days later.
10944686|NCT00781508|OG001|Outcome|Placebo First Then Sildenafil|placebo orally, then sildenafil 50 mg orally 2 days later.
10944687|NCT00781508|EG000|Reported Event|Sildenafil First Then Placebo|Effect of sildenafil first on left ventricular filling pressures, then effect of placebo on left ventricular filling pressure
10944688|NCT00781508|EG001|Reported Event|Placebo First Then Sildenafil|Effect of placebo on left ventricular filing pressures, then effect of sildenafil on left ventricular filling pressure.
10944689|NCT00781599|BG000|Baseline|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
10944690|NCT00781599|BG001|Baseline|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
10944691|NCT00781599|BG002|Baseline|Total|Total of all reporting groups
10944692|NCT00781599|FG000|Participant Flow|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
10944693|NCT00781599|FG001|Participant Flow|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
10944694|NCT00781599|OG000|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
10944695|NCT00781599|OG001|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
10944696|NCT00781599|EG000|Reported Event|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
10944697|NCT00781599|EG001|Reported Event|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
11177491|NCT02041299|OG000|Outcome|Deferiprone|Patients who received deferiprone and were evaluable for LIC and cardiac MRI T2*
11177492|NCT02041299|OG001|Outcome|Deferoxamine|Patients who received deferoxamine and were evaluable for LIC and cardiac MRI T2*
10944698|NCT00781768|BG000|Baseline|Standard PO Ondanestron + Dexamethason|Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
10944699|NCT00781768|BG001|Baseline|Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason|Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
10944700|NCT00781768|BG002|Baseline|Total|Total of all reporting groups
10944701|NCT00781768|FG000|Participant Flow|Standard PO Ondanestron + Dexamethason|Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
10944702|NCT00781768|FG001|Participant Flow|Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason|Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
10944703|NCT00781768|OG000|Outcome|Standard PO Ondanestron + Dexamethason|Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
10944704|NCT00781768|OG001|Outcome|Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason|Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
10944705|NCT00781768|EG000|Reported Event|Standard PO Ondanestron + Dexamethason|Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
10944706|NCT00781768|EG001|Reported Event|Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason|Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
10944707|NCT00781859|BG000|Baseline|Ocriplasmin 125µg|125µg microplasmin intravitreal injection
10944708|NCT00781859|BG001|Baseline|Placebo|Intravitreal injection of placebo
10944709|NCT00781859|BG002|Baseline|Total|Total of all reporting groups
10944710|NCT00781859|FG000|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
10944711|NCT00781859|FG001|Participant Flow|Placebo|Intravitreal injection of placebo
10944712|NCT00781859|OG000|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
11177493|NCT02041299|OG000|Outcome|Deferiprone|Patients who received deferiprone and were evaluable for serum ferritin. In contrast to liver and cardiac iron, for which the first post-baseline assessment took place at Month 6, that for serum ferritin took place at Month 3. Since fewer patients had withdrawn by Month 3 than by Month 6, there were more evaluable patients for this measure than for the other two.
10944713|NCT00781859|OG001|Outcome|Placebo|Intravitreal injection of placebo
10944714|NCT00781859|EG000|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
10944715|NCT00781859|EG001|Reported Event|Placebo|Intravitreal injection of placebo
10944716|NCT00781885|BG000|Baseline|Beraprost Sodium|Beraprost Sodium Modified Release (BPS-MR) 60 mcg tablets, administered orally, twice daily (BID). Doses were escalated by 1 tablet BID weekly, as tolerated, to a maximum dose of 600 mcg BID.
10944717|NCT00781885|FG000|Participant Flow|Beraprost Sodium|Beraprost Sodium Modified Release (BPS-MR) 60 mcg tablets, administered orally, twice daily (BID). Doses were escalated by 1 tablet BID weekly, as tolerated, to a maximum dose of 600 mcg BID.
11192174|NCT02137512|OG001|Outcome|5-Month 24/7 Closed-Loop|24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
10944718|NCT00781885|OG000|Outcome|Beraprost Sodium|Beraprost Sodium Modified Release (BPS-MR) 60 mcg tablets, administered orally, twice daily (BID). Doses were escalated by 1 tablet BID weekly, as tolerated, to a maximum dose of 600 mcg BID.
10944719|NCT00781885|EG000|Reported Event|Beraprost Sodium|Beraprost Sodium Modified Release (BPS-MR) 60 mcg tablets, administered orally, twice daily (BID). Doses were escalated by 1 tablet BID weekly, as tolerated, to a maximum dose of 600 mcg BID.
10944720|NCT00781898|BG000|Baseline|Depot Naltrexone|Participants who were randomized to receive Extended Release Naltrexone
10944721|NCT00781898|BG001|Baseline|Placebo|Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
10944722|NCT00781898|BG002|Baseline|Total|Total of all reporting groups
10944723|NCT00781898|FG000|Participant Flow|Depot Naltrexone|Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
10944724|NCT00781898|FG001|Participant Flow|Placebo|Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
10944725|NCT00781898|OG000|Outcome|Depot Naltrexone|Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
10944726|NCT00781898|OG001|Outcome|Placebo|Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
10944727|NCT00781898|EG000|Reported Event|Depot Naltrexone|Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
10944728|NCT00781898|EG001|Reported Event|Placebo|Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
10944729|NCT00781911|BG000|Baseline|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944730|NCT00781911|BG001|Baseline|Islet Cell Carcinoma|"Participants received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944731|NCT00781911|BG002|Baseline|Total|Total of all reporting groups
10944732|NCT00781911|FG000|Participant Flow|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg intravenously (IV) over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944733|NCT00781911|FG001|Participant Flow|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944734|NCT00781911|OG000|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944735|NCT00781911|OG001|Outcome|Islet Cell Carcinoma|Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.
10944736|NCT00781911|OG001|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944737|NCT00781911|OG001|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study.~Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944738|NCT00781911|EG000|Reported Event|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944739|NCT00781911|EG001|Reported Event|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
10944740|NCT00781937|BG000|Baseline|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
10944741|NCT00781937|BG001|Baseline|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
10944742|NCT00781937|BG002|Baseline|Total|Total of all reporting groups
10944743|NCT00781937|FG000|Participant Flow|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
10944744|NCT00781937|FG001|Participant Flow|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
10944745|NCT00781937|OG000|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
10944746|NCT00781937|OG001|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
10944747|NCT00781937|EG000|Reported Event|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
10944748|NCT00781937|EG001|Reported Event|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
10944749|NCT00781950|BG000|Baseline|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
10944750|NCT00781950|BG001|Baseline|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
11177494|NCT02041299|OG001|Outcome|Deferoxamine|Patients who received deferoxamine and were evaluable for serum ferritin. In contrast to liver and cardiac iron, for which the first post-baseline assessment took place at Month 6, that for serum ferritin took place at Month 3. Since fewer patients had withdrawn by Month 3 than by Month 6, there were more evaluable patients for this measure than for the other two.
11177495|NCT02041299|OG000|Outcome|Deferiprone|Patients who received deferiprone and were evaluable for quality of life
11177496|NCT02041299|OG001|Outcome|Deferoxamine|Patients who received deferoxamine and were evaluable for quality of life
11177497|NCT02041299|EG000|Reported Event|Deferiprone|"Patients randomized to the deferiprone arm will be prescribed either tablets or liquid medication.~Deferiprone"
11177498|NCT02041299|EG001|Reported Event|Deferoxamine|"Patients randomized to the deferoxamine arm will be prescribed the drug as per the approved US prescribing information.~Deferoxamine"
11177499|NCT02041325|BG000|Baseline|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
11177500|NCT02041325|BG001|Baseline|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
11177501|NCT02041325|BG002|Baseline|Total|Total of all reporting groups
11177502|NCT02041325|FG000|Participant Flow|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
10944751|NCT00781950|BG002|Baseline|Total|Total of all reporting groups
10944752|NCT00781950|FG000|Participant Flow|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
11177503|NCT02041325|FG001|Participant Flow|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
11177504|NCT02041325|OG000|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.~Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks."
11177505|NCT02041325|OG001|Outcome|Placebo|"Placebo will be administered for 7 days prior to and 7 days after the vaccine.~Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine."
11177506|NCT02041325|OG000|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
11177507|NCT02041325|OG001|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
11177508|NCT02041325|OG000|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.~Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine."
11177509|NCT02041325|OG001|Outcome|Placebo|"Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.~Placebo: Subjects will receive placebo for 7 days prior to and 7 days after the vaccine."
11177510|NCT02041325|EG000|Reported Event|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
11177511|NCT02041325|EG001|Reported Event|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
11177512|NCT02041377|BG000|Baseline|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11177513|NCT02041377|FG000|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11177514|NCT02041377|OG000|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11177515|NCT02041377|EG000|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
11177516|NCT02041429|BG000|Baseline|Phase I Dose Level 0:|"Paclitaxel + Ruxolitiniib 10 mg Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 10 mg orally twice daily for 4 cycles~1 cycle = 21 days~Participants with stable disease or better will have the opportunity to continue on single agent 10 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
11177517|NCT02041429|BG001|Baseline|Phase I Dose Level 1:|"Paclitaxel + Ruxolitiniib 15 mg Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 10 mg orally twice daily for 4 cycles~1 cycle = 21 days~Participants with stable disease or better will have the opportunity to continue on single agent 10 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
11341678|NCT03687125|BG001|Baseline|Tinostamustine 220 mg/m^2|Participants received single dose of tinostamustine 220 mg/m^2 IV injection followed by ASCT on Day 1.
10944753|NCT00781950|FG001|Participant Flow|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
10944754|NCT00781950|OG000|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat and wheat bran to replace the flaxseed daily for one year.
10944755|NCT00781950|OG001|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
10944756|NCT00781950|OG000|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
10944757|NCT00781950|EG000|Reported Event|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
10944758|NCT00781950|EG001|Reported Event|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
10944759|NCT00781963|BG000|Baseline|CBT-I|Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a health educator.
10944760|NCT00781963|BG001|Baseline|Control|Non-directive sleep education provided in 5 group sessions by a health educator.
10944761|NCT00781963|BG002|Baseline|Total|Total of all reporting groups
10944762|NCT00781963|FG000|Participant Flow|CBT-I|Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a health educator
10944763|NCT00781963|FG001|Participant Flow|Control|Non-directive sleep education provided in 5 group sessions by a health educator.
10944764|NCT00781963|OG000|Outcome|CBT-I|Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.
10944765|NCT00781963|OG001|Outcome|Control|Non-directive sleep education provided in 5 group sessions by a health educator.
10944766|NCT00781963|EG000|Reported Event|CBT-I|Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.
10944767|NCT00781963|EG001|Reported Event|Control|Non-directive sleep education provided in 5 group sessions by a health educator.
10944768|NCT00782067|BG000|Baseline|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
10944769|NCT00782067|FG000|Participant Flow|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
10944770|NCT00782067|OG000|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
10944771|NCT00782067|EG000|Reported Event|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
10944772|NCT00782171|BG000|Baseline|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
10944773|NCT00782171|BG001|Baseline|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
10944774|NCT00782171|BG002|Baseline|Total|Total of all reporting groups
10944775|NCT00782171|FG000|Participant Flow|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
10944776|NCT00782171|FG001|Participant Flow|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
10944777|NCT00782171|OG000|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
10944778|NCT00782171|OG001|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
10944779|NCT00782171|EG000|Reported Event|Immediate Loading|SLActive Implant(s) will be restored with a temporary restoration on the day of surgery.
10944780|NCT00782171|EG001|Reported Event|Early Loading|Healing caps will be placed on the SLActive Implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
10944781|NCT00782210|BG000|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10944782|NCT00782210|BG001|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10944783|NCT00782210|BG002|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944784|NCT00782210|BG003|Baseline|Total|Total of all reporting groups
10944785|NCT00782210|FG000|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10944786|NCT00782210|FG001|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10944787|NCT00782210|FG002|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944788|NCT00782210|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10944789|NCT00782210|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
11177518|NCT02041429|BG002|Baseline|Phase I Dose Level 2:|"Paclitaxel + Ruxolitiniib 20 mg Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 10 mg orally twice daily for 4 cycles~1 cycle = 21 days~Participants with stable disease or better will have the opportunity to continue on single agent 10 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
10944790|NCT00782210|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944791|NCT00782210|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
10944792|NCT00782210|OG001|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10944793|NCT00782210|OG002|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944794|NCT00782210|OG000|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
10944795|NCT00782210|OG001|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
10944796|NCT00782210|OG002|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
10944797|NCT00782210|OG003|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
10944798|NCT00782210|OG004|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
10944799|NCT00782210|OG005|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
10944800|NCT00782210|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10944801|NCT00782210|EG001|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10944802|NCT00782210|EG002|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944803|NCT00782275|BG000|Baseline|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
10944804|NCT00782275|FG000|Participant Flow|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
10944805|NCT00782275|OG000|Outcome|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
10944806|NCT00782275|EG000|Reported Event|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
10944807|NCT00782340|BG000|Baseline|Not Randomized|Patients entered open label droxidopa dose titration, but did not proceed into washout and randomization.
10944808|NCT00782340|BG001|Baseline|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10944809|NCT00782340|BG002|Baseline|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10944810|NCT00782340|BG003|Baseline|Total|Total of all reporting groups
10944811|NCT00782340|FG000|Participant Flow|Open-Label Titration|All patients titrated to their optimal dose of droxidopa for up to 2 weeks during open-label dose titration.
10944812|NCT00782340|FG001|Participant Flow|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10944813|NCT00782340|FG002|Participant Flow|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10944814|NCT00782340|OG000|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10944815|NCT00782340|OG001|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10944816|NCT00782340|EG000|Reported Event|Open-Label Titration|All patients treated with study drug during dose titration (7-14 days)
10944817|NCT00782340|EG001|Reported Event|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10944818|NCT00782340|EG002|Reported Event|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
10944819|NCT00782379|BG000|Baseline|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
10944820|NCT00782379|FG000|Participant Flow|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
10944821|NCT00782379|OG000|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
10944822|NCT00782379|EG000|Reported Event|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
10944823|NCT00782418|BG000|Baseline|All Patients|All patients from all arms
10944824|NCT00782418|FG000|Participant Flow|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
10944825|NCT00782418|FG001|Participant Flow|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
10944826|NCT00782418|FG002|Participant Flow|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
10944827|NCT00782418|FG003|Participant Flow|Exenatide 5 ug Down Dosed to Placebo (HGC)|Hyperglycemic Clamp: Treatment Group Exenatide 5 ug down dosed to placebo
10944828|NCT00782418|FG004|Participant Flow|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
10944829|NCT00782418|FG005|Participant Flow|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
10944830|NCT00782418|FG006|Participant Flow|Placebo (HGC or GGI)|Hyperglycemic Clamp or Graded Glucose Infusion: Treatment Group Placebo
11341679|NCT03687125|BG002|Baseline|Total|Total of all reporting groups
10944831|NCT00782418|OG000|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
10944832|NCT00782418|OG001|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
10944833|NCT00782418|OG002|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
10944834|NCT00782418|OG003|Outcome|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
10944835|NCT00782418|OG004|Outcome|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
10944836|NCT00782418|OG005|Outcome|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
10944837|NCT00782418|EG000|Reported Event|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
10944838|NCT00782418|EG001|Reported Event|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
10944839|NCT00782418|EG002|Reported Event|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
10944840|NCT00782418|EG003|Reported Event|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
10944841|NCT00782418|EG004|Reported Event|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
10944842|NCT00782418|EG005|Reported Event|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
10944843|NCT00782496|BG000|Baseline|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
11177519|NCT02041429|BG003|Baseline|Phase I Dose Level 3:|"Paclitaxel + Ruxolitiniib 25 mg Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 10 mg orally twice daily for 4 cycles~1 cycle = 21 days~Participants with stable disease or better will have the opportunity to continue on single agent 10 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
10944844|NCT00782496|BG001|Baseline|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
10944845|NCT00782496|BG002|Baseline|Total|Total of all reporting groups
11177520|NCT02041429|BG004|Baseline|Total|Total of all reporting groups
11177521|NCT02041429|FG000|Participant Flow|Phase I Dose Level 0: Paclitaxel + Ruxolitiniib 10 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 10 mg orally twice daily for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent 10 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
10944846|NCT00782496|FG000|Participant Flow|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
10944847|NCT00782496|FG001|Participant Flow|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
10944848|NCT00782496|OG000|Outcome|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
10944849|NCT00782496|OG001|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
10944850|NCT00782496|OG000|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
10944851|NCT00782496|EG000|Reported Event|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
10944852|NCT00782496|EG001|Reported Event|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
10944853|NCT00782509|BG000|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10944854|NCT00782509|BG001|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10944855|NCT00782509|BG002|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944856|NCT00782509|BG003|Baseline|Total|Total of all reporting groups
10944857|NCT00782509|FG000|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10944858|NCT00782509|FG001|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10944859|NCT00782509|FG002|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944860|NCT00782509|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10944861|NCT00782509|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10944862|NCT00782509|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944863|NCT00782509|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
10944864|NCT00782509|OG000|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
10944865|NCT00782509|OG001|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
10944866|NCT00782509|OG002|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
10944867|NCT00782509|OG003|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
10944868|NCT00782509|OG004|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
10944869|NCT00782509|OG005|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
10944870|NCT00782509|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10944871|NCT00782509|EG001|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10944872|NCT00782509|EG002|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10944873|NCT00782626|BG000|Baseline|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
10944874|NCT00782626|FG000|Participant Flow|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
11192175|NCT02137512|OG000|Outcome|5-Month 24/7 Closed-Loop|24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
10944875|NCT00782626|OG000|Outcome|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
10944876|NCT00782626|EG000|Reported Event|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
10944877|NCT00782639|BG000|Baseline|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
10944878|NCT00782639|BG001|Baseline|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
10944879|NCT00782639|BG002|Baseline|Total|Total of all reporting groups
10944880|NCT00782639|FG000|Participant Flow|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
10944881|NCT00782639|FG001|Participant Flow|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
10944882|NCT00782639|OG000|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
10944883|NCT00782639|OG001|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
10944884|NCT00782639|OG000|Outcome|Iopamiro-370|(Iopamidol injection at the 370 milligrams of iodine per milliliter [mgI/mL] concentration)
10944885|NCT00782639|OG001|Outcome|Visipaque 320|(Iodixanol injection at the 320 milligrams of iodine per milliliter [mgI/mL] concentration)
10944886|NCT00782639|EG000|Reported Event|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
10944887|NCT00782639|EG001|Reported Event|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
10944888|NCT00782717|BG000|Baseline|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
10944889|NCT00782717|BG001|Baseline|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
10944890|NCT00782717|BG002|Baseline|Total|Total of all reporting groups
10944891|NCT00782717|FG000|Participant Flow|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
10944892|NCT00782717|FG001|Participant Flow|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
10944893|NCT00782717|OG000|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
10944894|NCT00782717|OG001|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
10944895|NCT00782717|EG000|Reported Event|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
10944896|NCT00782717|EG001|Reported Event|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
10944897|NCT00782756|BG000|Baseline|RT, With Temozolomide and Bevacizumab|"This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.~Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions."
10944898|NCT00782756|FG000|Participant Flow|RT, With Temozolomide and Bevacizumab|"This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.~Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions."
10944899|NCT00782756|OG000|Outcome|RT, With Temozolomide and Bevacizumab|"This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.~Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions."
10944900|NCT00782756|EG000|Reported Event|RT, With Temozolomide and Bevacizumab|This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
10944901|NCT00782795|BG000|Baseline|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
10944902|NCT00782795|BG001|Baseline|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
10944903|NCT00782795|BG002|Baseline|Total|Total of all reporting groups
10944904|NCT00782795|FG000|Participant Flow|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
10944905|NCT00782795|FG001|Participant Flow|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
10944906|NCT00782795|OG000|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
10944907|NCT00782795|OG001|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
10944908|NCT00782795|EG000|Reported Event|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
10944909|NCT00782795|EG001|Reported Event|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
10944910|NCT00782821|BG000|Baseline|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV) Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily).
10944911|NCT00782821|BG001|Baseline|RATG/Rituxan|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV)+ Rituximab 375mg/m2 IV~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
10944912|NCT00782821|BG002|Baseline|RATG/Velcade|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
10944913|NCT00782821|BG003|Baseline|RATG/Rituxan/Velcade|"Thymoglobulin x 4 doses (1.5mg/kg IV)+ Rituximab 200mg/m2 IV + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
10944914|NCT00782821|BG004|Baseline|Total|Total of all reporting groups
10944915|NCT00782821|FG000|Participant Flow|Rabbit Antithymocyte Globulin (rATG)|"Thymoglobulin x 6 doses (1.5mg/kg IV).~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
10944916|NCT00782821|FG001|Participant Flow|RATG/Rituxan|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Rituximab 375mg/m2 IV~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
10944917|NCT00782821|FG002|Participant Flow|RATG/Velcade|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone."
10944918|NCT00782821|FG003|Participant Flow|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses (1.5mg/kg IV). + Rituximab 200mg/m2 IV + Bortezomib 1.3 mg/m2 IVP Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone.
10944919|NCT00782821|OG000|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
10944920|NCT00782821|OG001|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
11177522|NCT02041429|FG001|Participant Flow|Phase I Dose Level 1: Paclitaxel + Ruxolitiniib 15 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 15 mg orally twice daily for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent 15 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
10944921|NCT00782821|OG002|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
10944922|NCT00782821|OG003|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
10944923|NCT00782821|OG002|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Bortezomib
10944924|NCT00782821|OG003|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
10944925|NCT00782821|OG000|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV)
10944926|NCT00782821|OG000|Outcome|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)~Rabbit Antithymocyte Globulin (RATG): RATG"
10944927|NCT00782821|OG001|Outcome|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan~RATG/Rituxan: RATG/Rituxan~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
10944928|NCT00782821|OG002|Outcome|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
10944929|NCT00782821|OG003|Outcome|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade~RATG/Velcade: RATG/Velcade"
10944930|NCT00782821|EG000|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)~Rabbit Antithymocyte Globulin (RATG): RATG"
10944931|NCT00782821|EG001|Reported Event|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan~RATG/Rituxan: RATG/Rituxan~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
10944932|NCT00782821|EG002|Reported Event|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
10944933|NCT00782821|EG003|Reported Event|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade~RATG/Velcade: RATG/Velcade"
10944934|NCT00782834|BG000|Baseline|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
10944935|NCT00782834|FG000|Participant Flow|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
10944936|NCT00782834|OG000|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
10944937|NCT00782834|EG000|Reported Event|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
10944938|NCT00783094|BG000|Baseline|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
10944939|NCT00783094|BG001|Baseline|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
10944940|NCT00783094|BG002|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
10944941|NCT00783094|BG003|Baseline|Total|Total of all reporting groups
10944942|NCT00783094|FG000|Participant Flow|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
10944943|NCT00783094|FG001|Participant Flow|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
10944944|NCT00783094|FG002|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
10944945|NCT00783094|OG000|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
10944946|NCT00783094|OG001|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
10944947|NCT00783094|OG002|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
10944948|NCT00783094|EG000|Reported Event|Tadalafil 2.5 mg - Double-Blind Phase|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.
10944949|NCT00783094|EG001|Reported Event|Tadalafil 5 mg - Double-Blind Phase|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
11177523|NCT02041429|FG002|Participant Flow|Phase I Dose Level 2: Paclitaxel + Ruxolitiniib 20 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 20 mg orally twice daily for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent 20 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal"
11177524|NCT02041429|FG003|Participant Flow|Phase I Dose Level 3: Paclitaxel + Ruxolitiniib 25 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 25 mg orally twice daily for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent 20 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
10944950|NCT00783094|EG002|Reported Event|Placebo - Double-Blind Phase|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase."
10944951|NCT00783094|EG003|Reported Event|Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.
10944952|NCT00783094|EG004|Reported Event|Tadalafil 5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.
10944953|NCT00783094|EG005|Reported Event|Placebo: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.
10944954|NCT00783198|BG000|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944955|NCT00783198|BG001|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944956|NCT00783198|BG002|Baseline|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944957|NCT00783198|BG003|Baseline|Total|Total of all reporting groups
10944958|NCT00783198|FG000|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944959|NCT00783198|FG001|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944960|NCT00783198|FG002|Participant Flow|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944961|NCT00783198|OG000|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944962|NCT00783198|OG001|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944963|NCT00783198|OG002|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944964|NCT00783198|EG000|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944965|NCT00783198|EG001|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944966|NCT00783198|EG002|Reported Event|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
10944967|NCT00783289|BG000|Baseline|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
10944968|NCT00783289|BG001|Baseline|Benralizumab 25 mg|Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
10944969|NCT00783289|BG002|Baseline|Benralizumab 100 mg|Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
10944970|NCT00783289|BG003|Baseline|Benralizumab 200 mg|Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
10944971|NCT00783289|BG004|Baseline|Total|Total of all reporting groups
10944972|NCT00783289|FG000|Participant Flow|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
10944973|NCT00783289|FG001|Participant Flow|Benralizumab 25 mg|Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
10944974|NCT00783289|FG002|Participant Flow|Benralizumab 100 mg|Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
11177525|NCT02041429|OG000|Outcome|All Phase I Participants|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib orally twice daily according to the established dose escalation schedule for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent Ruxolitinib at the established dose until disease progression, unacceptable toxicity or patient withdrawal."
10944975|NCT00783289|FG003|Participant Flow|Benralizumab 200 mg|Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
10944976|NCT00783289|OG000|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
10944977|NCT00783289|OG001|Outcome|Benralizumab 25 mg|Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
10944978|NCT00783289|OG002|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
10944979|NCT00783289|OG003|Outcome|Benralizumab 200 mg|Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
10944980|NCT00783289|OG000|Outcome|Benralizumab 25 mg|Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
10944981|NCT00783289|OG001|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
10944982|NCT00783289|OG002|Outcome|Benralizumab 200 mg|Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
10944983|NCT00783289|EG000|Reported Event|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
10944984|NCT00783289|EG001|Reported Event|Benralizumab 25 mg|Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
10944985|NCT00783289|EG002|Reported Event|Benralizumab 100 mg|Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
10944986|NCT00783289|EG003|Reported Event|Benralizumab 200 mg|Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
10944987|NCT00783302|BG000|Baseline|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
10944988|NCT00783302|FG000|Participant Flow|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
10944989|NCT00783302|OG000|Outcome|Sensitivity - Subject Follow-up Period 1 Month|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
10944990|NCT00783302|OG001|Outcome|Sensitivity - Subject Follow-up Period 6 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
10944991|NCT00783302|OG002|Outcome|Sensitivity - Subject Follow-up Period 12 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
10944992|NCT00783302|OG000|Outcome|Positive Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
10944993|NCT00783302|OG001|Outcome|Positive Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
10944994|NCT00783302|OG002|Outcome|Positive Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
10944995|NCT00783302|OG000|Outcome|Specificity - Subject Follow-up Period 1 Month|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
10944996|NCT00783302|OG001|Outcome|Specificity - Subject Follow-up Period 6 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
10944997|NCT00783302|OG002|Outcome|Specificity - Subject Follow-up Period 12 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
10944998|NCT00783302|OG000|Outcome|Negative Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
10944999|NCT00783302|OG001|Outcome|Negative Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
10945000|NCT00783302|OG002|Outcome|Negative Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
10945001|NCT00783302|OG000|Outcome|Follow-up Period at 1 Month|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 1 month.
10945002|NCT00783302|OG001|Outcome|Follow-up Period at 6 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 6 months.
10945003|NCT00783302|OG002|Outcome|Follow-up Period at 12 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 12 months.
10945004|NCT00783302|EG000|Reported Event|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
10945005|NCT00783432|BG000|Baseline|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
10945006|NCT00783432|BG001|Baseline|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
10945007|NCT00783432|BG002|Baseline|Total|Total of all reporting groups
10945008|NCT00783432|FG000|Participant Flow|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
10945009|NCT00783432|FG001|Participant Flow|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
10945010|NCT00783432|OG000|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
10945011|NCT00783432|OG001|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
10945012|NCT00783432|EG000|Reported Event|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
10945013|NCT00783432|EG001|Reported Event|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
10945014|NCT00783614|BG000|Baseline|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
10945015|NCT00783614|BG001|Baseline|ART and Placebo|Start ART immediately and initiate placebo pill daily
10945016|NCT00783614|BG002|Baseline|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
10945017|NCT00783614|BG003|Baseline|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
10945018|NCT00783614|BG004|Baseline|Total|Total of all reporting groups
10945019|NCT00783614|FG000|Participant Flow|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
10945020|NCT00783614|FG001|Participant Flow|ART and Placebo|Start ART immediately and initiate placebo pill daily
10945021|NCT00783614|FG002|Participant Flow|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
10945022|NCT00783614|FG003|Participant Flow|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
10945023|NCT00783614|OG000|Outcome|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
10945024|NCT00783614|OG001|Outcome|ART and Placebo|Start ART immediately and initiate placebo pill daily
10945025|NCT00783614|OG002|Outcome|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
10945026|NCT00783614|OG003|Outcome|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
10945027|NCT00783614|EG000|Reported Event|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
10945028|NCT00783614|EG001|Reported Event|ART and Placebo|Start ART immediately and initiate placebo pill daily
10945029|NCT00783614|EG002|Reported Event|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
10945030|NCT00783614|EG003|Reported Event|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
10945031|NCT00783692|BG000|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2.
10945032|NCT00783692|BG001|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
10945033|NCT00783692|BG002|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
10945034|NCT00783692|BG003|Baseline|Total|Total of all reporting groups
10945035|NCT00783692|FG000|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
10945036|NCT00783692|FG001|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
10945037|NCT00783692|FG002|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
10945038|NCT00783692|FG003|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
10945039|NCT00783692|FG004|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
10945040|NCT00783692|FG005|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
10945041|NCT00783692|FG006|Participant Flow|Maintenance Phase: Non-Responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
10945042|NCT00783692|OG000|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
10945043|NCT00783692|OG001|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
10945044|NCT00783692|OG000|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
10945045|NCT00783692|OG001|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
10945046|NCT00783692|OG002|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
10945047|NCT00783692|OG001|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
10945048|NCT00783692|OG000|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
10945049|NCT00783692|OG002|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
10945050|NCT00783692|EG000|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
10945051|NCT00783692|EG001|Reported Event|VDZ/PBO|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
10945052|NCT00783692|EG002|Reported Event|VDZ/VDZ|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
10945053|NCT00783705|BG000|Baseline|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
10945054|NCT00783705|BG001|Baseline|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
10945055|NCT00783705|BG002|Baseline|Total|Total of all reporting groups
10945056|NCT00783705|FG000|Participant Flow|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
10945057|NCT00783705|FG001|Participant Flow|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
11177526|NCT02041429|OG000|Outcome|Phase I Dose Level 0: Paclitaxel + Ruxolitiniib 10 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 10 mg orally twice daily~cycle duration=21 days~Participants with stable disease or better after 4 cycles could continue with ruxolitinib alone."
10945058|NCT00783705|OG000|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
11177527|NCT02041429|OG001|Outcome|Phase I Dose Level 1: Paclitaxel + Ruxolitiniib 15 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 15 mg orally twice daily~cycle duration=21 days~Participants with stable disease or better after 4 cycles could continue with ruxolitinib alone."
10945059|NCT00783705|OG001|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
10945060|NCT00783705|EG000|Reported Event|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
10945061|NCT00783705|EG001|Reported Event|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
10945062|NCT00783718|BG000|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
10945063|NCT00783718|BG001|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
10945064|NCT00783718|BG002|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
10945065|NCT00783718|BG003|Baseline|Total|Total of all reporting groups
10945066|NCT00783718|FG000|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
10945067|NCT00783718|FG001|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
10945068|NCT00783718|FG002|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
10945069|NCT00783718|FG003|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
10945070|NCT00783718|FG004|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
10945071|NCT00783718|FG005|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
10945072|NCT00783718|FG006|Participant Flow|Maintenance Phase: Non-responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
11177528|NCT02041429|OG002|Outcome|Phase I Dose Level 2: Paclitaxel + Ruxolitiniib 20 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 20 mg orally twice daily~cycle duration=21 days~Participants with stable disease or better after 4 cycles could continue with ruxolitinib alone."
11177529|NCT02041429|OG003|Outcome|Phase I Dose Level 3: Paclitaxel + Ruxolitiniib 25 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 25 mg orally twice daily~cycle duration=21 days~Participants with stable disease or better after 4 cycles could continue with ruxolitinib alone."
11177530|NCT02041429|OG000|Outcome|Phase I Dose Level 0: Paclitaxel + Ruxolitiniib 10 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 10 mg orally twice daily for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent 10 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
11177531|NCT02041429|OG001|Outcome|Phase I Dose Level 1: Paclitaxel + Ruxolitiniib 15 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 15 mg orally twice daily for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent 15 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
11177532|NCT02041429|OG002|Outcome|Phase I Dose Level 2: Paclitaxel + Ruxolitiniib 20 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 20 mg orally twice daily for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent 20 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal"
11177533|NCT02041429|OG003|Outcome|Phase I Dose Level 3: Paclitaxel + Ruxolitiniib 25 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 25 mg orally twice daily for 4 cycles~1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent 20 mg Ruxolitinib until disease progression, unacceptable toxicity or patient withdrawal."
11177534|NCT02041429|EG000|Reported Event|Phase I Dose Level 0: Paclitaxel + Ruxolitiniib 10 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 10 mg orally twice daily~cycle duration=21 days~Participants with stable disease or better after 4 cycles could continue with ruxolitinib alone."
11177535|NCT02041429|EG001|Reported Event|Phase I Dose Level 1: Paclitaxel + Ruxolitiniib 15 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 15 mg orally twice daily~cycle duration=21 days~Participants with stable disease or better after 4 cycles could continue with ruxolitinib alone."
11177536|NCT02041429|EG002|Reported Event|Phase I Dose Level 2: Paclitaxel + Ruxolitiniib 20 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 20 mg orally twice daily~cycle duration=21 days~Participants with stable disease or better after 4 cycles could continue with ruxolitinib alone."
11177537|NCT02041429|EG003|Reported Event|Phase I Dose Level 3: Paclitaxel + Ruxolitiniib 25 mg|"Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib 25 mg orally twice daily~cycle duration=21 days~Participants with stable disease or better after 4 cycles could continue with ruxolitinib alone."
11177538|NCT02041494|BG000|Baseline|Synthetic|"Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.~SoftMesh/Ventralight ST"
11177539|NCT02041494|BG001|Baseline|Biologic|"Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.~Strattice"
11177540|NCT02041494|BG002|Baseline|Total|Total of all reporting groups
11177541|NCT02041494|FG000|Participant Flow|Biologic|"Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.~Strattice"
11177542|NCT02041494|FG001|Participant Flow|Synthetic|"Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.~SoftMesh/Ventralight ST"
11177543|NCT02041494|OG000|Outcome|Biologic|"Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.~Strattice"
11177544|NCT02041494|OG001|Outcome|Synthetic|"Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.~SoftMesh/Ventralight ST"
11177545|NCT02041494|OG001|Outcome|Synthetic|"Patients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene.~Ventralight"
11177546|NCT02041494|EG000|Reported Event|Biologic|"Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.~Strattice"
10945073|NCT00783718|OG000|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
10945074|NCT00783718|OG001|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
10945075|NCT00783718|OG000|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
10945076|NCT00783718|OG001|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
10945077|NCT00783718|OG002|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
11177547|NCT02041494|EG001|Reported Event|Synthetic|"Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.~SoftMesh/Ventralight ST"
10945078|NCT00783718|EG000|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
10945079|NCT00783718|EG001|Reported Event|Vedolizumab Then Placebo|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
10945080|NCT00783718|EG002|Reported Event|Vedolizumab|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
10945081|NCT00783796|BG000|Baseline|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
10945082|NCT00783796|FG000|Participant Flow|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
10945083|NCT00783796|OG000|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
10945084|NCT00783796|OG000|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
10945085|NCT00783796|OG000|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
10945086|NCT00783796|EG000|Reported Event|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
10945087|NCT00783835|BG000|Baseline|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
10945088|NCT00783835|FG000|Participant Flow|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
10945089|NCT00783835|OG000|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
10945090|NCT00783835|EG000|Reported Event|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
10945091|NCT00783952|BG000|Baseline|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
10945092|NCT00783952|FG000|Participant Flow|Mixed Venous Oxygen and Calculation of Saturation|"Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
10945093|NCT00783952|OG000|Outcome|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
10945094|NCT00783952|OG001|Outcome|Patients With Cerebral/Somatic Tissue Oximeter Device|"Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
10945095|NCT00783952|EG000|Reported Event|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
10945096|NCT00783965|BG000|Baseline|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
10945097|NCT00783965|BG001|Baseline|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
10945098|NCT00783965|BG002|Baseline|Total|Total of all reporting groups
10945099|NCT00783965|FG000|Participant Flow|Arm I|0.1% tazarotene cream first, then placebo
10945100|NCT00783965|FG001|Participant Flow|Arm II|Vehicle (placebo) first, then 0.1% tazarotene cream
10945101|NCT00783965|OG000|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
10945102|NCT00783965|OG001|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
10945103|NCT00783965|EG000|Reported Event|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
10945104|NCT00783965|EG001|Reported Event|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
10945105|NCT00784030|BG000|Baseline|Polycystic Kidney Disease (PKD) Patients|
11177548|NCT02041520|BG000|Baseline|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
10945106|NCT00784030|BG001|Baseline|Healthy Patients|
10945107|NCT00784030|BG002|Baseline|Total|Total of all reporting groups
10945108|NCT00784030|FG000|Participant Flow|Polycystic Kidney Disease (PKD) Patients|Patients who present with polycystic kidney disease (PKD)
10945109|NCT00784030|FG001|Participant Flow|Healthy Patients|
10945110|NCT00784030|OG000|Outcome|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
10945111|NCT00784030|OG001|Outcome|Healthy Controls|Healthy Controls
10945112|NCT00784030|EG000|Reported Event|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
10945113|NCT00784030|EG001|Reported Event|Healthy Controls|Healthy Controls
10945114|NCT00784095|BG000|Baseline|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
10945115|NCT00784095|BG001|Baseline|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
10945116|NCT00784095|BG002|Baseline|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
10945117|NCT00784095|BG003|Baseline|Total|Total of all reporting groups
10945118|NCT00784095|FG000|Participant Flow|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
10945119|NCT00784095|FG001|Participant Flow|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
10945120|NCT00784095|FG002|Participant Flow|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
10945121|NCT00784095|OG000|Outcome|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
10945122|NCT00784095|OG001|Outcome|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
10945123|NCT00784095|OG002|Outcome|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
10945124|NCT00784095|OG000|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
10945125|NCT00784095|OG001|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
10945126|NCT00784095|OG002|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
10945127|NCT00784095|EG000|Reported Event|Preparation and Completion|"Subjects in the first group (treatment) met with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
10945128|NCT00784095|EG001|Reported Event|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects listened to a non-guided relaxation CD."
10945129|NCT00784095|EG002|Reported Event|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
10945130|NCT00784134|BG000|Baseline|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
10945131|NCT00784134|BG001|Baseline|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
10945132|NCT00784134|BG002|Baseline|Total|Total of all reporting groups
10945133|NCT00784134|FG000|Participant Flow|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
10945134|NCT00784134|FG001|Participant Flow|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
10945135|NCT00784134|OG000|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
10945136|NCT00784134|OG001|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
10945137|NCT00784134|EG000|Reported Event|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
10945138|NCT00784134|EG001|Reported Event|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
10945139|NCT00784147|BG000|Baseline|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
10945140|NCT00784147|BG001|Baseline|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
10945141|NCT00784147|BG002|Baseline|Total|Total of all reporting groups
10945142|NCT00784147|FG000|Participant Flow|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
10945143|NCT00784147|FG001|Participant Flow|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
10945144|NCT00784147|OG000|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
10945145|NCT00784147|OG001|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
10945146|NCT00784147|EG000|Reported Event|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
10945147|NCT00784147|EG001|Reported Event|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
10945148|NCT00784225|BG000|Baseline|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7-12 years.~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10945149|NCT00784225|BG001|Baseline|Selenium + Vitamin E|"Selenium and vitamin E daily for 7-12 years. Selenium: 200 mcg daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years"
10945150|NCT00784225|BG002|Baseline|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7-12 years.~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10945151|NCT00784225|BG003|Baseline|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7-12 years.~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10945152|NCT00784225|BG004|Baseline|Total|Total of all reporting groups
10945153|NCT00784225|FG000|Participant Flow|Selenium + Vitamin E Placebo|"Patients received selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10945154|NCT00784225|FG001|Participant Flow|Selenium + Vitamin E|"Patients received selenium and vitamin E daily for 7 - 12 years~Selenium: 200 mcg 1 pill by mouth daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years"
10945155|NCT00784225|FG002|Participant Flow|Vitamin E Placebo + Selenium Placebo|"Patients received vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo:1 pill daily by mouth for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10945156|NCT00784225|FG003|Participant Flow|Vitamin E + Selenium Placebo|"Patients received vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU by mouth daily for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10945157|NCT00784225|OG000|Outcome|AMD: Selenium Active|"Patients received selenium and either Vitamin E or vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10945158|NCT00784225|OG001|Outcome|AMD: Selenium Placebo|"Patients received selenium placebo and either Vitamin E or vitamin E placebo daily for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10945159|NCT00784225|OG002|Outcome|AMD: Vitamin E Active|"Patients received vitamin E and either selenium or selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10945160|NCT00784225|OG003|Outcome|AMD: Vitamin E Placebo|"Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10945161|NCT00784225|OG000|Outcome|Cataract: Selenium Active|"Patients received selenium and either vitamin E or vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10945162|NCT00784225|OG001|Outcome|Cataract: Selenium Placebo|"Patients received selenium placebo and either vitamin E or vitamin E placebo daily for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
10945163|NCT00784225|OG002|Outcome|Cataract: Vitamin E Active|"Patients received vitamin E and either selenium or selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10945164|NCT00784225|OG003|Outcome|Cataract: Vitamin E Placebo|"Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Selenium placebo: 1 pill by mouth daily for 7 - 12 years"
10945165|NCT00784225|EG000|Reported Event|Selenium + Vitamin E Placebo|Selenium + Vitamin E placebo
10945166|NCT00784225|EG001|Reported Event|Selenium + Vitamin E|Selenium + Vitamin E
10945167|NCT00784225|EG002|Reported Event|Placebo|Placebo
10945168|NCT00784225|EG003|Reported Event|Vitamin E + Selenium Placebo|Vitamin E + Selenium placebo
10945169|NCT00784238|BG000|Baseline|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
10945170|NCT00784238|FG000|Participant Flow|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
10945171|NCT00784238|OG000|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
10945172|NCT00784238|OG000|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
10945173|NCT00784238|OG001|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
10945174|NCT00784238|OG002|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
11177549|NCT02041520|BG001|Baseline|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
10945175|NCT00784238|EG000|Reported Event|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
10945176|NCT00784277|BG000|Baseline|Placebo|IR Treatment : 1 capsule for 14 days
10945177|NCT00784277|BG001|Baseline|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
10945178|NCT00784277|BG002|Baseline|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
10945179|NCT00784277|BG003|Baseline|Oxycodone|IR Treatment : 10mg capsule for 14 days
10945180|NCT00784277|BG004|Baseline|Total|Total of all reporting groups
10945181|NCT00784277|FG000|Participant Flow|Placebo|IR Treatment : 1 capsule for 14 days
10945182|NCT00784277|FG001|Participant Flow|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
10945183|NCT00784277|FG002|Participant Flow|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
10945184|NCT00784277|FG003|Participant Flow|Oxycodone|IR Treatment : 10mg for 14 days
10945185|NCT00784277|FG004|Participant Flow|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
10945186|NCT00784277|FG005|Participant Flow|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
10945187|NCT00784277|FG006|Participant Flow|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
10945188|NCT00784277|OG000|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
10945189|NCT00784277|OG001|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
10945190|NCT00784277|OG002|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
10945191|NCT00784277|OG003|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
10945192|NCT00784277|EG000|Reported Event|Placebo|IR Treatment : 1 capsule for 14 days
10945193|NCT00784277|EG001|Reported Event|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
10945194|NCT00784277|EG002|Reported Event|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
10945195|NCT00784277|EG003|Reported Event|Oxycodone|IR Treatment : 10mg for 14 days
10945196|NCT00784277|EG004|Reported Event|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
10945197|NCT00784277|EG005|Reported Event|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
10945198|NCT00784277|EG006|Reported Event|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
11177550|NCT02041520|BG002|Baseline|Total|Total of all reporting groups
11177551|NCT02041520|FG000|Participant Flow|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
10945199|NCT00784303|BG000|Baseline|DTC Cohort|Participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) orally, once daily or 10 mg lenvatinib orally twice daily in 28-day treatment cycles. Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.
10945200|NCT00784303|BG001|Baseline|MTC Cohort|Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles.
10945201|NCT00784303|BG002|Baseline|Total|Total of all reporting groups
10945202|NCT00784303|FG000|Participant Flow|DTC Cohort|Participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) orally, once daily or 10 mg lenvatinib orally twice daily in 28-day treatment cycles. Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.
10945203|NCT00784303|FG001|Participant Flow|MTC Cohort|Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles.
10945204|NCT00784303|OG000|Outcome|DTC Cohort|Participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) orally, once daily or 10 mg lenvatinib orally twice daily in 28-day treatment cycles. Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.
10945205|NCT00784303|OG001|Outcome|MTC Cohort|Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles.
10945206|NCT00784303|OG000|Outcome|MTC Cohort|Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles.
10945207|NCT00784303|EG000|Reported Event|DTC Cohort|Participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) orally, once daily or 10 mg lenvatinib orally twice daily in 28-day treatment cycles. Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.
10945208|NCT00784303|EG001|Reported Event|MTC Cohort|Participants with medullary thyroid cancer (MTC) received 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily continuously in 28-day treatment cycles.
10945209|NCT00784368|BG000|Baseline|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945210|NCT00784368|BG001|Baseline|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945211|NCT00784368|BG002|Baseline|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945212|NCT00784368|BG003|Baseline|Total|Total of all reporting groups
10945213|NCT00784368|FG000|Participant Flow|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945214|NCT00784368|FG001|Participant Flow|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945215|NCT00784368|FG002|Participant Flow|FN (Switched Treatment)|Participants with febrile (with fever) neutropenia (a decrease in white blood cells) (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945216|NCT00784368|OG000|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945217|NCT00784368|OG001|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945218|NCT00784368|OG002|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945219|NCT00784368|OG000|Outcome|SFI (JK1211 Monotherapy)|Participants with deep-seated mycosis (SFI) received JK1211 orally (taken by mouth; to be swallowed) in the dose range of 20 milliliter per day (ml/day) to 40 ml/day for 12 weeks as per Investigator's discretion.
10963584|NCT00872989|OG001|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
10963585|NCT00872989|OG000|Outcome|Docetaxel|
10945220|NCT00784368|OG000|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945221|NCT00784368|OG001|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945222|NCT00784368|EG000|Reported Event|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945223|NCT00784368|EG001|Reported Event|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945224|NCT00784368|EG002|Reported Event|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion.
10945225|NCT00784459|BG000|Baseline|Placebo|Placebo : Treatment with Placebo, IV
10945226|NCT00784459|BG001|Baseline|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
10945227|NCT00784459|BG002|Baseline|Total|Total of all reporting groups
11177552|NCT02041520|FG001|Participant Flow|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
11177553|NCT02041520|OG000|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
11341680|NCT03687125|FG000|Participant Flow|Tinostamustine 180 mg/m^2|Participants received single dose of tinostamustine 180 milligrams per meter square (mg/m^2) intravenous (IV) injection on Day -1 followed by autologous stem cell transplantation (ASCT) on Day 1.
10945228|NCT00784459|FG000|Participant Flow|Placebo|Placebo : Treatment with Placebo, IV
10945229|NCT00784459|FG001|Participant Flow|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
10945230|NCT00784459|OG000|Outcome|Placebo|Placebo : Treatment with Placebo, IV
10945231|NCT00784459|OG001|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
10945232|NCT00784459|EG000|Reported Event|Placebo|Placebo : Treatment with Placebo, IV
10945233|NCT00784459|EG001|Reported Event|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
10945234|NCT00784524|BG000|Baseline|LMI Vaccination + IL-2|"Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.~allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.~aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection."
10945235|NCT00784524|FG000|Participant Flow|LMI Vaccination + IL-2|"Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.~allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.~aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection."
10945236|NCT00784524|OG000|Outcome|LMI Vaccination + IL-2|"Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.~allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.~aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection."
10945237|NCT00784524|EG000|Reported Event|LMI Vaccination + IL-2|"Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.~allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.~aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection."
10945238|NCT00784550|BG000|Baseline|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
10945239|NCT00784550|BG001|Baseline|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
10945240|NCT00784550|BG002|Baseline|Total|Total of all reporting groups
10945241|NCT00784550|FG000|Participant Flow|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
10945242|NCT00784550|FG001|Participant Flow|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
10945243|NCT00784550|OG000|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
10945244|NCT00784550|OG001|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
10945245|NCT00784550|EG000|Reported Event|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
10945246|NCT00784550|EG001|Reported Event|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
10945247|NCT00784563|BG000|Baseline|Continuous Training-Years 1 & 2|Participants who were randomized to continuous training in the first 2 years of the study.
10945248|NCT00784563|BG001|Baseline|Interval Training -Years 1 & 2|Participants who were randomized to interval training in the first 2 years of the study.
10945249|NCT00784563|BG002|Baseline|Continuous-Year 3|Participants who were assigned to continuous training in the third year of the study without randomization. Due to potentially increased risk of knee pain without additional fitness benefits, we dropped the interval group for the third year.
11177554|NCT02041520|OG001|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
11177555|NCT02041520|OG000|Outcome|Omega 3 Fatty Acids|Patients who received omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and 2 in the night...
11177556|NCT02041520|OG001|Outcome|Placebo|Patiemts who received placebo for 6 months
11177557|NCT02041520|EG000|Reported Event|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
11177558|NCT02041520|EG001|Reported Event|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
11177559|NCT02041702|BG000|Baseline|Cardiac MRI Scan Group|Non-diagnostic cardiac MRI scan
11177560|NCT02041702|BG001|Baseline|Control Group|No non-diagnostic cardiac MRI scan
10945250|NCT00784563|BG003|Baseline|Total|Total of all reporting groups
10945251|NCT00784563|FG000|Participant Flow|Continuous Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. The goal for continuous training was to remain within 70-80% of HRmax throughout the session.
10945252|NCT00784563|FG001|Participant Flow|Interval Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. Interval trainees alternated every 3 minutes between slower (60-70% of HRmax) and faster (80-90% of HRmax) walking.
10945253|NCT00784563|FG002|Participant Flow|Continuous Training - Year 3|Participant were assigned to continuous training without randomization.
10945254|NCT00784563|OG000|Outcome|Completers|The participants who completed 6 months of aerobic training
10945255|NCT00784563|OG000|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
10945256|NCT00784563|EG000|Reported Event|Continuous Training|This group consists of 21 subjects who were randomized to continuous training in the first two years of the study and 17 subjects who were assigned to continuous training without randomization in the third year of the study. Thus, total group size is 38.
10945257|NCT00784563|EG001|Reported Event|Interval Training|This group consists of 22 subjects who were randomized to interval training in the first two years of the study. No subjects were assigned to the interval training in the third year of the study.
10945258|NCT00784641|BG000|Baseline|Novel Bausch & Lomb Contact Lens|"Novel Bausch & Lomb daily disposable contact lenses~Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks."
10945259|NCT00784641|BG001|Baseline|SofLens|"Bausch & Lomb SofLens daily disposable contact lenses~Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks."
10945260|NCT00784641|BG002|Baseline|Acuvue|"Johnson and Johnson 1-Day Acuvue Moist contact lenses~Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks."
10945261|NCT00784641|BG003|Baseline|Total|Total of all reporting groups
10945262|NCT00784641|FG000|Participant Flow|Novel Bausch & Lomb Contact Lens|"Novel Bausch & Lomb daily disposable contact lenses~Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks."
10945263|NCT00784641|FG001|Participant Flow|SofLens|"Bausch & Lomb SofLens daily disposable contact lenses~Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks."
10945264|NCT00784641|FG002|Participant Flow|Acuvue|"Johnson and Johnson 1-Day Acuvue Moist contact lenses~Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks."
10945265|NCT00784641|OG000|Outcome|Novel Bausch & Lomb Contact Lens|"Novel Bausch & Lomb daily disposable contact lenses~Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks."
10945266|NCT00784641|OG001|Outcome|SofLens|"Bausch & Lomb SofLens daily disposable contact lenses~Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks."
10963586|NCT00872989|OG001|Outcome|Docetaxel + Vandetanib|
11177561|NCT02041702|BG002|Baseline|Total|Total of all reporting groups
11177562|NCT02041702|FG000|Participant Flow|Cardiac MRI Scan Group|Non-diagnostic cardiac MRI scan
11177563|NCT02041702|FG001|Participant Flow|Control Group|No non-diagnostic cardiac MRI scan
11177564|NCT02041702|OG000|Outcome|Cardiac MRI Scan Group|Non-diagnostic cardiac MRI scan
11177565|NCT02041702|OG001|Outcome|Control Group|No non-diagnostic cardiac MRI scan
10945267|NCT00784641|OG002|Outcome|Acuvue|"Johnson and Johnson 1-Day Acuvue Moist contact lenses~Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks."
10945268|NCT00784641|EG000|Reported Event|Novel Bausch & Lomb Contact Lens|"Novel Bausch & Lomb daily disposable contact lenses~Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks."
10945269|NCT00784641|EG001|Reported Event|SofLens|"Bausch & Lomb SofLens daily disposable contact lenses~Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks."
10945270|NCT00784641|EG002|Reported Event|Acuvue|"Johnson and Johnson 1-Day Acuvue Moist contact lenses~Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks."
10945271|NCT00784654|BG000|Baseline|All Enrolled Subjects|
10945272|NCT00784654|FG000|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
10945273|NCT00784654|FG001|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
10945274|NCT00784654|FG002|Participant Flow|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
10945275|NCT00784654|OG000|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
10945276|NCT00784654|OG001|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
10945277|NCT00784654|OG000|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
10945278|NCT00784654|OG000|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
10945279|NCT00784654|OG001|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
10945280|NCT00784654|OG000|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
10945281|NCT00784654|EG000|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM).
10945282|NCT00784654|EG001|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM for up to 6 weeks.
10945283|NCT00784654|EG002|Reported Event|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM for up to 6 weeks.
10945284|NCT00784693|BG000|Baseline|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.
10945285|NCT00784693|BG001|Baseline|Placebo|A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
10945286|NCT00784693|BG002|Baseline|Total|Total of all reporting groups
10945287|NCT00784693|FG000|Participant Flow|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.
10945288|NCT00784693|FG001|Participant Flow|Placebo|A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
10945289|NCT00784693|OG000|Outcome|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.
10945290|NCT00784693|OG001|Outcome|Placebo|A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
10945291|NCT00784693|EG000|Reported Event|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.
10945292|NCT00784693|EG001|Reported Event|Placebo|A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
10945293|NCT00784719|BG000|Baseline|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
10945294|NCT00784719|BG001|Baseline|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
10945295|NCT00784719|BG002|Baseline|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
10945296|NCT00784719|BG003|Baseline|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
10945297|NCT00784719|BG004|Baseline|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
10945298|NCT00784719|BG005|Baseline|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
10945299|NCT00784719|BG006|Baseline|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
10945300|NCT00784719|BG007|Baseline|Total|Total of all reporting groups
10945301|NCT00784719|FG000|Participant Flow|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
10945302|NCT00784719|FG001|Participant Flow|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
10945303|NCT00784719|FG002|Participant Flow|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
10945304|NCT00784719|FG003|Participant Flow|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
10945305|NCT00784719|FG004|Participant Flow|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
10945306|NCT00784719|FG005|Participant Flow|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
10945307|NCT00784719|FG006|Participant Flow|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
10945308|NCT00784719|OG000|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
10945309|NCT00784719|OG001|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
10945310|NCT00784719|OG002|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
10945311|NCT00784719|OG003|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
10945312|NCT00784719|OG004|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
10945313|NCT00784719|OG005|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
10945314|NCT00784719|OG006|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
10945315|NCT00784719|EG000|Reported Event|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
10945316|NCT00784719|EG001|Reported Event|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
10945317|NCT00784719|EG002|Reported Event|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
10945318|NCT00784719|EG003|Reported Event|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
10945319|NCT00784719|EG004|Reported Event|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
10945320|NCT00784719|EG005|Reported Event|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
10945321|NCT00784719|EG006|Reported Event|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
11177566|NCT02041702|EG000|Reported Event|Cardiac MRI Scan Group|Non-diagnostic cardiac MRI scan
10945322|NCT00784758|BG000|Baseline|Fenzian Device|20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).
10945323|NCT00784758|BG001|Baseline|Sham Device|20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
10945324|NCT00784758|BG002|Baseline|Total|Total of all reporting groups
10945325|NCT00784758|FG000|Participant Flow|Fenzian Device|20-minute treatments with the Fenzian Device, 3 times per week for 5 weeks (15 treatments total)
10945326|NCT00784758|FG001|Participant Flow|Sham Device|20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
10945327|NCT00784758|OG000|Outcome|Fenzian Device|20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).
10945328|NCT00784758|OG001|Outcome|Sham Device|20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
10945329|NCT00784758|OG000|Outcome|Fenzian Device|Subjects randomized to this arm will receive treatment with the Fenzian Device
10945330|NCT00784758|OG001|Outcome|Sham Device|Subjects randomized to this arm will receive treatment with the sham device.
10945331|NCT00784758|EG000|Reported Event|Fenzian Device|Subjects randomized to this arm will receive treatment with the Fenzian Device
10945332|NCT00784758|EG001|Reported Event|Sham Device|Subjects randomized to this arm will receive treatment with the sham device.
10945333|NCT00784784|BG000|Baseline|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
10945334|NCT00784784|BG001|Baseline|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
10945335|NCT00784784|BG002|Baseline|Total|Total of all reporting groups
10945336|NCT00784784|FG000|Participant Flow|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
10945337|NCT00784784|FG001|Participant Flow|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
10945338|NCT00784784|OG000|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
10945339|NCT00784784|OG001|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
10945340|NCT00784784|EG000|Reported Event|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
10963587|NCT00872989|OG002|Outcome|Vandetanib|
11177567|NCT02041702|EG001|Reported Event|Control Group|No non-diagnostic cardiac MRI scan
11240726|NCT02481375|OG001|Outcome|Multiple Micronutrients Without Iron|"This formulation has the 14 micronutrients included in the UNIMMAP formulation, but does not include iron.~Women will receive the multiple micronutrient without iron for 12 weeks.~Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine"
11240727|NCT02481375|OG002|Outcome|Iron Only|"This formulation only has 60 mg elemental iron.~Women will receive iron for 12 weeks.~Iron: 12-wk supplementation of iron"
11240728|NCT02481375|OG003|Outcome|Placebo|"This formulation is a placebo.~Women will receive a placebo for 12 weeks.~Placebo: 12-wk supplementation of placebo"
10945341|NCT00784784|EG001|Reported Event|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
10945342|NCT00784810|BG000|Baseline|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
10945343|NCT00784810|BG001|Baseline|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
10945344|NCT00784810|BG002|Baseline|Total|Total of all reporting groups
10945345|NCT00784810|FG000|Participant Flow|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
10945346|NCT00784810|FG001|Participant Flow|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
10945347|NCT00784810|OG000|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
10945348|NCT00784810|OG001|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
10945349|NCT00784810|EG000|Reported Event|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
10945350|NCT00784810|EG001|Reported Event|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
10945351|NCT00784836|BG000|Baseline|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
11177568|NCT02041923|BG000|Baseline|Attention Control|"Mothers received equal amount of attention from the team~H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants."
11177569|NCT02041923|BG001|Baseline|H-HOPE Intervention|"H-HOPE was administered twice daily by the mother.~H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants."
10945352|NCT00784836|FG000|Participant Flow|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
10945353|NCT00784836|OG000|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
10945354|NCT00784836|EG000|Reported Event|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
10945355|NCT00784849|BG000|Baseline|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
10945356|NCT00784849|FG000|Participant Flow|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
10945357|NCT00784849|OG000|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
10945358|NCT00784849|EG000|Reported Event|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
10945359|NCT00784875|BG000|Baseline|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
10945360|NCT00784875|BG001|Baseline|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
10945361|NCT00784875|BG002|Baseline|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
10945362|NCT00784875|BG003|Baseline|Placebo|Participants received placebo in Period B (2-week treatment period).
10945363|NCT00784875|BG004|Baseline|Total|Total of all reporting groups
10945364|NCT00784875|FG000|Participant Flow|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
10945365|NCT00784875|FG001|Participant Flow|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
10945366|NCT00784875|FG002|Participant Flow|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
10945367|NCT00784875|FG003|Participant Flow|Placebo|Participants received placebo in a 2-week treatment period.
10945368|NCT00784875|OG000|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
10945369|NCT00784875|OG001|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
10945370|NCT00784875|OG002|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
10945371|NCT00784875|OG003|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
10945372|NCT00784875|OG000|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
10945373|NCT00784875|OG001|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
10945374|NCT00784875|OG002|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
10945375|NCT00784875|OG003|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
10945376|NCT00784875|OG000|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period
10945377|NCT00784875|EG000|Reported Event|Period B - LY2624803 1 mg|Patients received LY2624803 1 mg in Period B (2-week treatment period.
10945378|NCT00784875|EG001|Reported Event|Period B - LY2624803 3 mg|Patients received LY2624803 3 mg in Period B (2-week treatment period).
10945379|NCT00784875|EG002|Reported Event|Period B - Placebo|Patients received placebo in Period B (2-week treatment period).
10945380|NCT00784875|EG003|Reported Event|Period B - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
10945381|NCT00784875|EG004|Reported Event|Period C - LY2624803 1 mg|Patients received LY2624803 1 mg in Period C (2-week treatment period.
10945382|NCT00784875|EG005|Reported Event|Period C - LY2624803 3 mg|Patients received LY2624803 3 mg in Period C (2-week treatment period).
10945383|NCT00784875|EG006|Reported Event|Period C - Placebo|Patients received placebo in Period C (2-week treatment period).
10945384|NCT00784875|EG007|Reported Event|Period C - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period C (2-week treatment period).
10945385|NCT00784875|EG008|Reported Event|Period D - LY2624803 1 mg|Patients received LY2624803 1 mg in Period D (2-week treatment period.
10963588|NCT00872989|OG000|Outcome|Vandetanib|Vandetanib treated patients
11177570|NCT02041923|BG002|Baseline|Total|Total of all reporting groups
10945386|NCT00784875|EG009|Reported Event|Period D - LY2624803 3 mg|Patients received LY2624803 3 mg in Period D (2-week treatment period).
10945387|NCT00784875|EG010|Reported Event|Period D - Placebo|Patients received placebo in Period D (2-week treatment period).
10945388|NCT00784875|EG011|Reported Event|Period D - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period D (2-week treatment period).
10945389|NCT00784927|BG000|Baseline|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1.~20 mg Lenalidomide taken orally on days 1-21.~250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.~40 mg Dexamethasone orally on days 1, 8, 15, 22."
10945390|NCT00784927|FG000|Participant Flow|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21.~250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.~40 mg Dexamethasone orally on days 1, 8, 15, 22."
10945391|NCT00784927|OG000|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
10945392|NCT00784927|OG000|Outcome|Treatment|"Participants with lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia) will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles and analyzed as a separate cohort:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.~rituximab~cyclophosphamide~dexamethasone~lenalidomide"
10945393|NCT00784927|EG000|Reported Event|Treatment|40 mg Dexamethasone orally on days 1, 8, 15, 22.
10945394|NCT00784979|BG000|Baseline|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA >/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
10945395|NCT00784979|FG000|Participant Flow|CMVIG Followed by PP|MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
10945396|NCT00784979|OG000|Outcome|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
10945397|NCT00784979|EG000|Reported Event|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
10945398|NCT00785044|BG000|Baseline|AdreView™ - Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.
10945399|NCT00785044|FG000|Participant Flow|AdreView™- Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of adverse cardiac events (ACEs).
10945400|NCT00785044|OG000|Outcome|AdreView™ - HF Group (With No Adverse Cardiac Events)|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with no ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
10945401|NCT00785044|OG001|Outcome|AdreView™- HF Group (With Adverse Cardiac Events)|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
10945402|NCT00785044|EG000|Reported Event|AdreView™ - Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.
10945403|NCT00785213|BG000|Baseline|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
11341681|NCT03687125|FG001|Participant Flow|Tinostamustine 220 mg/m^2|Participants received single dose of tinostamustine 220 mg/m^2 IV injection on Day -1 followed by ASCT on Day 1.
10945404|NCT00785213|FG000|Participant Flow|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
10945405|NCT00785213|OG000|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
10945406|NCT00785213|OG001|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
10945407|NCT00785213|EG000|Reported Event|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period.
10945408|NCT00785213|EG001|Reported Event|Quinine Sulfate Alone|On Days 4-7, subjects received a dose of quinine sulfate 648 mg (2 x 324 mg capsules) every 8 hours beginning with the 7:15 a.m. dose on Day 4 and continuing through the 11:15 p.m. dose on Day 7.
10945409|NCT00785213|EG002|Reported Event|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects were co-administered a dose of rosiglitazone 4mg and quinine sulfate 648 mg (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
10945410|NCT00785486|BG000|Baseline|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
10945411|NCT00785486|FG000|Participant Flow|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
10945412|NCT00785486|OG000|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for midazolam.
10945413|NCT00785486|OG001|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for 1-hydroxy-midazolam, the primary metabolite of midazolam
10945414|NCT00785486|OG002|Outcome|Quinine - Qualaquin(Quinine) Alone|On the morning of day 9 after taking Qualaquin(quinine)capsules 324 mg orally every 8 hours for the prior 5 days, and following a fast of at least 10 hours all study participants received their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine) at this dose.
10945415|NCT00785486|OG003|Outcome|Midazolam - Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917. 12, 15 and 24 hours to determine Cmax for midazolam in the presence of Qualaquin (qunine)at steady state.
10945416|NCT00785486|OG004|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg concurrently. On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the Cmax for 1-hydroxy-midazolam in the presence of Qualaquin (quinine) at steady state.
10945417|NCT00785486|OG005|Outcome|Quinine - Qualaquin (Quinine) With Midazolam|On the morning of day 10 after taking Qualaquin (quinine)capsules 324 mg orally every 8 hours for the prior 6 days, and following a fast of at least 10 hours all study participants co-ingested oral dose s of midazolam 2 mg and their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine)in the presence of midazolam.
10945418|NCT00785486|OG000|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of midazolam and 1-hydroxymidazolam
10945419|NCT00785486|OG001|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of 1-hydroxy midazolam as calculated by the linear trapezoidal method.
10945420|NCT00785486|OG002|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
10945421|NCT00785486|OG003|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for 1-hydroxy midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
10945422|NCT00785486|OG000|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
10963589|NCT00872989|OG000|Outcome|Vandetanib|Patients elected to participant in the crossover registration in Vandetanib after progression in single agent docetaxel.
11341682|NCT03687125|OG000|Outcome|Tinostamustine 180 mg/m^2|Participants received single dose of tinostamustine 180 mg/m^2 IV injection on Day -1 followed by ASCT on Day 1.
10945423|NCT00785486|OG001|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for 1-hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
10945424|NCT00785486|OG002|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg . Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
10945425|NCT00785486|OG003|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin(quinine) 324 mg. Blood was drawn sufficient to characterize AUC inf for 1- hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
10945426|NCT00785486|OG000|Outcome|Qualaquin (Quinine) Alone|On the morning of day 9 after taking an oral dose of Qualaquin quinine)324 mg every 8 hours for the prior 5 days (Steady state) and following a fast of at least 10 hours all participants took a an additional 324 mg oral dose of the drug. Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(Quinine) alone over the following dosing interval (0 - 8 hours), as calculated by the linear trapezoidal method.
10945427|NCT00785486|OG001|Outcome|Qualaquin (Quinine) With Midazolam|On day 10 after six days of receiving Qualaquin 324 mg every 8 hours, and after a fast of at least 10 hours, patients received a 2 mg dose of midazolam and 324 mg of Qualaquin (quinine)(Steady state). Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(quinine) in the presence of midazolam over the final dosing interval (0 - 8 hours), as calculated by the linear trapezoidal method.
10945428|NCT00785486|EG000|Reported Event|Midazolam Alone|Adverse effects on day 1 after participants received 2mg of midazolam syrup orally.
10945429|NCT00785486|EG001|Reported Event|Qualaquin (Quinine) Alone|Adverse effects(ADR)while taking Qualaquin(quinine)324 mg alone orally every 8 hours on days 4-11. Results are reported as total for the 7 day period.
10945430|NCT00785486|EG002|Reported Event|Midazolam With Qualaquin (Quinine) Together|Adverse effects reported on day 10 after participants received 2 mg of midazolam syrup and 324 mg of Qualaquin(quinine)orally.
10945431|NCT00785512|BG000|Baseline|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
10945432|NCT00785512|BG001|Baseline|Placebo|Matching placebo tablets, oral administration
10945433|NCT00785512|BG002|Baseline|Total|Total of all reporting groups
10945434|NCT00785512|FG000|Participant Flow|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
10945435|NCT00785512|FG001|Participant Flow|Placebo|Matching placebo tablets, oral administration
10945436|NCT00785512|OG000|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
10945437|NCT00785512|OG001|Outcome|Placebo|Matching placebo tablets, oral administration
10945438|NCT00785512|EG000|Reported Event|Single-blind Nebivolol|Pre-randomization 12 week nebivolol treatment.
10945439|NCT00785512|EG001|Reported Event|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
11341683|NCT03687125|OG001|Outcome|Tinostamustine 220 mg/m^2|Participants received single dose of tinostamustine 220 mg/m^2 IV injection on Day -1 followed by ASCT on Day 1.
10945440|NCT00785512|EG002|Reported Event|Placebo|Matching placebo tablets, oral administration
10945441|NCT00785538|BG000|Baseline|3 mg/kg|"3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945442|NCT00785538|BG001|Baseline|6 mg/kg|"6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945443|NCT00785538|BG002|Baseline|10 mg/kg|"10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945444|NCT00785538|BG003|Baseline|15 mg/kg|"15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945445|NCT00785538|BG004|Baseline|Total|Total of all reporting groups
10963590|NCT00872989|EG000|Reported Event|Docetaxel|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
10963591|NCT00872989|EG001|Reported Event|Docetaxel + Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
10945446|NCT00785538|FG000|Participant Flow|3 mg/kg|"3 mg/kg IMC-A12 administered intravenously (I.V.) on Day 1 of a 2-week PK period prior to Cycle 1.~3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with stable disease (SD) could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945447|NCT00785538|FG001|Participant Flow|6 mg/kg|"6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945448|NCT00785538|FG002|Participant Flow|10 mg/kg|"10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945449|NCT00785538|FG003|Participant Flow|15 mg/kg|"15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945450|NCT00785538|OG000|Outcome|3 mg/kg|"3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945451|NCT00785538|OG001|Outcome|6 mg/kg|"6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945452|NCT00785538|OG002|Outcome|10 mg/kg|"10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945453|NCT00785538|OG003|Outcome|15 mg/kg|"15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945454|NCT00785538|OG002|Outcome|10 mg/kg|"10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945455|NCT00785538|EG000|Reported Event|3 mg/kg|"3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945456|NCT00785538|EG001|Reported Event|6 mg/kg|"6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945457|NCT00785538|EG002|Reported Event|10 mg/kg|"10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.~10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
11341684|NCT03687125|OG000|Outcome|Tinostamustine 180 mg/m^2|Participants received single dose of tinostamustine 180 mg/m^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.
10963592|NCT00872989|EG002|Reported Event|Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
10963593|NCT00873015|BG000|Baseline|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion 32 nmol/min/kg
10963594|NCT00873015|BG001|Baseline|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
10945458|NCT00785538|EG003|Reported Event|15 mg/kg|"15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.~Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule."
10945459|NCT00785577|BG000|Baseline|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
10945460|NCT00785577|BG001|Baseline|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
10945461|NCT00785577|BG002|Baseline|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
10945462|NCT00785577|BG003|Baseline|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
10945463|NCT00785577|BG004|Baseline|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
10945464|NCT00785577|BG005|Baseline|Total|Total of all reporting groups
10945465|NCT00785577|FG000|Participant Flow|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
10945466|NCT00785577|FG001|Participant Flow|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
10945467|NCT00785577|FG002|Participant Flow|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
10945468|NCT00785577|FG003|Participant Flow|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
10945469|NCT00785577|FG004|Participant Flow|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
10945470|NCT00785577|OG000|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
10945471|NCT00785577|OG001|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
10945472|NCT00785577|OG002|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
10945473|NCT00785577|OG003|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
10945474|NCT00785577|OG001|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
10945475|NCT00785577|OG002|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
10945476|NCT00785577|OG003|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
10945477|NCT00785577|OG004|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
10945478|NCT00785577|OG000|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
10945479|NCT00785577|OG001|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
10945480|NCT00785577|EG000|Reported Event|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks
10945481|NCT00785577|EG001|Reported Event|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week
10945482|NCT00785577|EG002|Reported Event|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
10945483|NCT00785577|EG003|Reported Event|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
10945484|NCT00785577|EG004|Reported Event|Pregabalin|Pregabalin thrice daily (TID) oral (po) for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
10945485|NCT00785577|EG005|Reported Event|Placebo Washout|A one-week washout period in which no placebo was taken.
10945486|NCT00785577|EG006|Reported Event|LY545694 21 mg Washout|A one-week washout period in which no LY545694 21 mg was taken.
10945487|NCT00785577|EG007|Reported Event|LY545694 49 mg Washout|A one-week washout period in which no LY545694 49 mg was taken.
10945488|NCT00785577|EG008|Reported Event|LY545694 105 mg Washout|A one-week washout period in which no LY545694 105 mg was taken.
10945489|NCT00785577|EG009|Reported Event|Pregabalin Washout|A one-week washout period in which no pregabalin was taken.
10945490|NCT00785629|BG000|Baseline|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
10945491|NCT00785629|BG001|Baseline|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
10945492|NCT00785629|BG002|Baseline|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
10945493|NCT00785629|BG003|Baseline|Placebo|
10945494|NCT00785629|BG004|Baseline|Total|Total of all reporting groups
10945495|NCT00785629|FG000|Participant Flow|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
10945496|NCT00785629|FG001|Participant Flow|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
10945497|NCT00785629|FG002|Participant Flow|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
10945498|NCT00785629|FG003|Participant Flow|Placebo|
10945499|NCT00785629|OG000|Outcome|All Active Treated Patients|All actively treated patients
10945500|NCT00785629|OG001|Outcome|All Placebo Treated Patients|All placebo treated patients
10945501|NCT00785629|EG000|Reported Event|Placebo|
10945502|NCT00785629|EG001|Reported Event|Lanthanum Carbonate|
10945503|NCT00785629|EG002|Reported Event|Sevelamer Carbonate|
10945504|NCT00785629|EG003|Reported Event|Calcium Acetate|
10963595|NCT00873015|BG002|Baseline|48 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 48 nmol/min/kg
10963596|NCT00873015|BG003|Baseline|64 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 64 nmol/min/kg
10963597|NCT00873015|BG004|Baseline|Total|Total of all reporting groups
10963598|NCT00873015|FG000|Participant Flow|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
10963599|NCT00873015|FG001|Participant Flow|Nitrite 32 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 32 nmol/min/kg
10963600|NCT00873015|FG002|Participant Flow|Nitrite 48 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 48 nmol/min/kg
10963601|NCT00873015|FG003|Participant Flow|Nitrite 64 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 64 nmol/min/kg
10963602|NCT00873015|OG000|Outcome|64 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 64 nmol/min/kg
10963603|NCT00873015|OG001|Outcome|48 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 48 nmol/min/kg
10963604|NCT00873015|OG002|Outcome|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 32 nmol/min/kg
10963605|NCT00873015|OG003|Outcome|Placebo|Intravenous saline administration
10963606|NCT00873015|OG003|Outcome|Placebo|Intravenous saline
10963607|NCT00873015|EG000|Reported Event|Nitrite|Sodium nitrite : 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
10963608|NCT00873015|EG001|Reported Event|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
10963609|NCT00873041|BG000|Baseline|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10963610|NCT00873041|BG001|Baseline|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10963611|NCT00873041|BG002|Baseline|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
10963612|NCT00873041|BG003|Baseline|Total|Total of all reporting groups
10963613|NCT00873041|FG000|Participant Flow|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10963614|NCT00873041|FG001|Participant Flow|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10963615|NCT00873041|FG002|Participant Flow|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10963616|NCT00873041|OG000|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
10963617|NCT00873041|OG001|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
10963618|NCT00873041|OG002|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
10963619|NCT00873041|OG002|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
10963620|NCT00873041|OG000|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
10963621|NCT00873041|OG000|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
11341685|NCT03687125|OG001|Outcome|Tinostamustine 220 mg/m^2|Participants received single dose of tinostamustine 220 mg/m^2 IV injection followed by ASCT on Day 1.
11341686|NCT03687125|EG000|Reported Event|Tinostamustine (180 mg/m^2)|Participants received single dose of 180 mg/m^2 tinostamustine IV injection on Day -1 followed by ASCT on Day 1.
10945505|NCT00785707|BG000|Baseline|Cochlear Implant|children less than 24 months at time of cochlear implantation
10945506|NCT00785707|FG000|Participant Flow|Cochlear Implant|children less than 24 months at time of cochlear implantation
10945507|NCT00785707|OG000|Outcome|Cochlear Implant|children less than 24 months at time of cochlear implantation
10945508|NCT00785707|EG000|Reported Event|Cochlear Implant|children less than 24 months at time of cochlear implantation
10945509|NCT00785772|BG000|Baseline|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
10945510|NCT00785772|FG000|Participant Flow|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
10945511|NCT00785772|OG000|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
10945512|NCT00785772|EG000|Reported Event|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
10945513|NCT00785785|BG000|Baseline|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
10945514|NCT00785785|BG001|Baseline|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
10945515|NCT00785785|BG002|Baseline|Total|Total of all reporting groups
10945516|NCT00785785|FG000|Participant Flow|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
10945517|NCT00785785|FG001|Participant Flow|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
10945518|NCT00785785|OG000|Outcome|Nilotinib|nilotinib 400 mg twice a day
10945519|NCT00785785|OG001|Outcome|Imatinib|imatinib 400 mg once daily
10945520|NCT00785785|EG000|Reported Event|Nilotinib|Exposure to Nilotinib only
10945521|NCT00785785|EG001|Reported Event|Imatinib|Exposure to Imatinib only
11177571|NCT02041923|FG000|Participant Flow|Attention Control|"Mothers received equal amount of attention from the team~H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants."
11341687|NCT03687125|EG001|Reported Event|Tinostamustine (220 mg/m^2)|Participants received single dose of 220 mg/m^2 tinostamustine IV injection on Day -1 followed by ASCT on Day 1.
10945522|NCT00785785|EG002|Reported Event|Crossover Nilotinib|exposure to imatinib and then nilotinib
10945523|NCT00785785|EG003|Reported Event|Crossover Imatinib|exposure to nilotinib and then imatinib
10945524|NCT00785928|BG000|Baseline|Placebo|Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945525|NCT00785928|BG001|Baseline|1 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945526|NCT00785928|BG002|Baseline|3 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945527|NCT00785928|BG003|Baseline|10 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945528|NCT00785928|BG004|Baseline|30 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945529|NCT00785928|BG005|Baseline|60 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945530|NCT00785928|BG006|Baseline|120 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945531|NCT00785928|BG007|Baseline|Total|Total of all reporting groups
10945532|NCT00785928|FG000|Participant Flow|Placebo|Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945533|NCT00785928|FG001|Participant Flow|1 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945534|NCT00785928|FG002|Participant Flow|3 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945535|NCT00785928|FG003|Participant Flow|10 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945536|NCT00785928|FG004|Participant Flow|30 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945537|NCT00785928|FG005|Participant Flow|60 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945538|NCT00785928|FG006|Participant Flow|120 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945539|NCT00785928|OG000|Outcome|Placebo|Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945540|NCT00785928|OG001|Outcome|1 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945541|NCT00785928|OG002|Outcome|3 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945542|NCT00785928|OG003|Outcome|10 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
11341688|NCT03687372|BG000|Baseline|Active|Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
10945543|NCT00785928|OG004|Outcome|30 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945544|NCT00785928|OG005|Outcome|60 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945545|NCT00785928|OG006|Outcome|120 mg LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10945546|NCT00785928|OG000|Outcome|Placebo|Placebo was administered subcutaneously (SC) every 4 weeks over a 24-week period.
10945547|NCT00785928|OG001|Outcome|1 mg LY2127399|1 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945548|NCT00785928|OG002|Outcome|3 mg LY2127399|3 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945549|NCT00785928|OG003|Outcome|10 mg LY2127399|10 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945550|NCT00785928|OG004|Outcome|30 mg LY2127399|30 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945551|NCT00785928|OG005|Outcome|60 mg LY2127399|60 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945552|NCT00785928|OG006|Outcome|120 mg LY2127399|120 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945553|NCT00785928|OG001|Outcome|1 mg LY2127399|1 milligram (mg) of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945554|NCT00785928|OG000|Outcome|1 mg LY2127399|1 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945555|NCT00785928|OG001|Outcome|3 mg LY2127399|3 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945556|NCT00785928|OG002|Outcome|10 mg LY2127399|10 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945557|NCT00785928|OG003|Outcome|30 mg LY2127399|30 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945558|NCT00785928|OG004|Outcome|60 mg LY2127399|60 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945559|NCT00785928|OG005|Outcome|120 mg of LY2127399|120 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945560|NCT00785928|OG005|Outcome|120 mg LY2127399|120 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945561|NCT00785928|EG000|Reported Event|Placebo|Placebo was administered subcutaneously (SC) every 4 weeks over a 24-week period.
10945562|NCT00785928|EG001|Reported Event|1 mg LY2127399|1 milligram (mg) of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945563|NCT00785928|EG002|Reported Event|3 mg LY2127399|3 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945564|NCT00785928|EG003|Reported Event|10 mg LY2127399|10 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945565|NCT00785928|EG004|Reported Event|30 mg LY2127399|30 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945566|NCT00785928|EG005|Reported Event|60 mg LY2127399|60 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945567|NCT00785928|EG006|Reported Event|120 mg LY2127399|120 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10945568|NCT00785928|EG007|Reported Event|Placebo - Follow-up Period|Participants were assessed but did not receive any study medication during the follow-up period.
10945569|NCT00785928|EG008|Reported Event|1 mg LY2127399 - Follow-up Period|Participants were assessed but did not receive any study medication during the follow-up period.
10945570|NCT00785928|EG009|Reported Event|3 mg LY2127399 - Follow-up Period|Participants were assessed but did not receive any study medication during the follow-up period.
10945571|NCT00785928|EG010|Reported Event|10 mg LY2127399 - Follow-up Period|Participants were assessed but did not receive any study medication during the follow-up period.
10945572|NCT00785928|EG011|Reported Event|30 mg LY2127399 - Follow-up Period|Participants were assessed but did not receive any study medication during the follow-up period.
10945573|NCT00785928|EG012|Reported Event|60 mg LY2127399 - Follow-up Period|Participants were assessed but did not receive any study medication during the follow-up period.
10945574|NCT00785928|EG013|Reported Event|120 mg LY2127399 - Follow-up Period|Participants were assessed but did not receive any study medication during the follow-up period.
10945575|NCT00785980|BG000|Baseline|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
11341689|NCT03687372|BG001|Baseline|Vehicle|Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
10945576|NCT00785980|FG000|Participant Flow|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
10945577|NCT00785980|OG000|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
10945578|NCT00785980|OG001|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
10945579|NCT00785980|EG000|Reported Event|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period. On Day 11 in the morning, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) following an overnight fast of 10 hours.
11341690|NCT03687372|BG002|Baseline|Total|Total of all reporting groups
10945580|NCT00785980|EG001|Reported Event|Ciprofloxacin Alone|Beginning on Day 8 in the morning and continuing through Day 11 in the evening, all subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice daily for a total of 8 doses.
10945581|NCT00785980|EG002|Reported Event|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, all subjects received a dose of quinine sulfate (2 x 324 mg capsules) co-administered with a dose of ciprofloxacin (1 x 500 mg tablet) after an overnight fast of at least 10 hours.
10945582|NCT00786019|BG000|Baseline|Ascorbic Acid - Control|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
10945583|NCT00786019|BG001|Baseline|Ascorbic Acid - Type 2 Diabetes|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
10945584|NCT00786019|BG002|Baseline|Total|Total of all reporting groups
10945585|NCT00786019|FG000|Participant Flow|Ascorbic Acid - Control|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
10945586|NCT00786019|FG001|Participant Flow|Ascorbic Acid - Type 2 Diabetes|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams Vitamin C per kilogram fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
10945587|NCT00786019|OG000|Outcome|Circumferential Strain - Control|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
10945588|NCT00786019|OG001|Outcome|Circumferential Strain - Type 2 Diabetes|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
10945589|NCT00786019|OG000|Outcome|Ejection Fraction - Control|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
10945590|NCT00786019|OG001|Outcome|Ejection Fraction - Type 2 Diabetes|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
10945591|NCT00786019|EG000|Reported Event|Ascorbic Acid - Control|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 g Vit C per kg fat-free mass per 100 ml of normal saline administered; Subjects will receive a bolus of 100mL Vit C solution given at 5ml/min over 20minutes followed by a drip-infusion given at 1.7ml/min."
10945592|NCT00786019|EG001|Reported Event|Ascorbic Acid - T2D|"All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.~Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.~Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 g Vit C per kg fat-free mass per 100 ml of normal saline administered; Subjects will receive a bolus of 100mL Vit C solution given at 5ml/min over 20minutes followed by a drip-infusion given at 1.7ml/min."
11341691|NCT03687372|FG000|Participant Flow|Hydrogen Peroxide 45% A-101|Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
10945593|NCT00786032|BG000|Baseline|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
10945594|NCT00786032|FG000|Participant Flow|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
10945595|NCT00786032|OG000|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
10945596|NCT00786032|OG000|Outcome|BCI Device|"The McGill Quality of Life (MQOL) is a 16 item scale that has five distinct sub-measures: physical well-being; physical symptoms; psychological symptoms; existential well-being; support. These sub-measures are averaged to give a MQOL total score.~The range of total score is from 0 (worst) to 10 (best)."
10945597|NCT00786032|OG000|Outcome|BCI Device - Time Assisting Patient With Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles. The time was measured of how long the the caregiver assisted the patient with the device."
10945598|NCT00786032|EG000|Reported Event|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
10945599|NCT00786188|BG000|Baseline|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
10945600|NCT00786188|BG001|Baseline|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
10945601|NCT00786188|BG002|Baseline|Total|Total of all reporting groups
10945602|NCT00786188|FG000|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Interventions Administered:~Subjects received Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime.~Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime."
10945603|NCT00786188|FG001|Participant Flow|Placebo - Sugar Pill|"Interventions Administered:~Subjects received placebo capsules administered once daily at bedtime.~Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive placebo administered once daily at bedtime."
10945604|NCT00786188|OG000|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg capsules.~Subjects will be randomized to one of the two treatments in a 1:1 ratio"
10945605|NCT00786188|OG001|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
10945606|NCT00786188|OG000|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
10945607|NCT00786188|OG000|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
10945608|NCT00786188|EG000|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
10945609|NCT00786188|EG001|Reported Event|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
10945610|NCT00786409|BG000|Baseline|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
10945611|NCT00786409|FG000|Participant Flow|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
10945612|NCT00786409|OG000|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
10945613|NCT00786409|EG000|Reported Event|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
10945614|NCT00786422|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
10945615|NCT00786422|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
10945616|NCT00786422|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
10945617|NCT00786422|OG000|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
10945618|NCT00786422|OG001|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
10945619|NCT00786422|EG000|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
10945620|NCT00786474|BG000|Baseline|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
10945621|NCT00786474|BG001|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
10945622|NCT00786474|BG002|Baseline|Total|Total of all reporting groups
11341692|NCT03687372|FG001|Participant Flow|Isopropyl Alcohol and Water Vehicle|Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
10945623|NCT00786474|FG000|Participant Flow|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
10945624|NCT00786474|FG001|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
10945625|NCT00786474|OG000|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
10945626|NCT00786474|OG001|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
10945627|NCT00786474|EG000|Reported Event|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
10945628|NCT00786474|EG001|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
10945629|NCT00786487|BG000|Baseline|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
10945630|NCT00786487|BG001|Baseline|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
10945631|NCT00786487|BG002|Baseline|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
10945632|NCT00786487|BG003|Baseline|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
10945633|NCT00786487|BG004|Baseline|Total|Total of all reporting groups
10945634|NCT00786487|FG000|Participant Flow|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
10945635|NCT00786487|FG001|Participant Flow|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
10945636|NCT00786487|FG002|Participant Flow|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
10945637|NCT00786487|FG003|Participant Flow|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
10945638|NCT00786487|OG000|Outcome|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
10945639|NCT00786487|OG001|Outcome|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
10945640|NCT00786487|OG002|Outcome|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
10945641|NCT00786487|OG003|Outcome|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
10945642|NCT00786487|EG000|Reported Event|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
10945643|NCT00786487|EG001|Reported Event|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
10945644|NCT00786487|EG002|Reported Event|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
10945645|NCT00786487|EG003|Reported Event|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
10945646|NCT00786565|BG000|Baseline|Akreos Intraocular Lens|
10945647|NCT00786565|FG000|Participant Flow|Akreos Intraocular Lens|Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
10945648|NCT00786565|OG000|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
10945649|NCT00786565|OG001|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
10945650|NCT00786565|EG000|Reported Event|Akreos Advanced Intraocular Lenses|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
10945651|NCT00786565|EG001|Reported Event|Akreos Adapt Intraocular Lens|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
10945652|NCT00786643|BG000|Baseline|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
10945653|NCT00786643|BG001|Baseline|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
10945654|NCT00786643|BG002|Baseline|Total|Total of all reporting groups
10945655|NCT00786643|FG000|Participant Flow|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
10945656|NCT00786643|FG001|Participant Flow|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
10945657|NCT00786643|OG000|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
10945658|NCT00786643|OG001|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
10945659|NCT00786643|EG000|Reported Event|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
10945660|NCT00786643|EG001|Reported Event|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
10945661|NCT00786799|BG000|Baseline|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
10945662|NCT00786799|BG001|Baseline|Placebo|"Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to non-omega-3 fatty acids."
10945663|NCT00786799|BG002|Baseline|Total|Total of all reporting groups
10945664|NCT00786799|FG000|Participant Flow|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
10945665|NCT00786799|FG001|Participant Flow|Placebo|"Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to non-omega-3 fatty acids."
10945666|NCT00786799|OG000|Outcome|Active Omega-3|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only
10945667|NCT00786799|OG001|Outcome|Placebo|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only
10945668|NCT00786799|OG002|Outcome|Comparison Between Omega-3 and Placebo Groups|Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
10945669|NCT00786799|OG000|Outcome|Active Omega-3 Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the active Omega-3 group (100% * ((One Year - Baseline)/Baseline)
10945670|NCT00786799|OG001|Outcome|Placebo Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the placebo group (100% * ((One Year - Baseline)/Baseline).
10945671|NCT00786799|OG000|Outcome|Active Omega-3 Group: Change in TNFα|
10945672|NCT00786799|OG001|Outcome|Placebo Group: Change in TNFα|
10945673|NCT00786799|EG000|Reported Event|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
10945674|NCT00786799|EG001|Reported Event|Placebo|"Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to non-omega-3 fatty acids."
10945675|NCT00786825|BG000|Baseline|Somatostatin|"Type 1 diabetes and Hypoglycemia unawareness~somatostatin: Somatostatin may be used to suppress endogenous insulin secretion"
10945676|NCT00786825|BG001|Baseline|Healthy Controls|Healthy control subjects
10945677|NCT00786825|BG002|Baseline|Total|Total of all reporting groups
10945678|NCT00786825|FG000|Participant Flow|Somatostatin|"Type 1 diabetes and Hypoglycemia unawareness~somatostatin: Somatostatin may be used to suppress endogenous insulin secretion"
10945679|NCT00786825|FG001|Participant Flow|Healthy Controls|Healthy control subjects
10945680|NCT00786825|OG000|Outcome|Somatostatin|"Type 1 diabetes and Hypoglycemia unawareness~somatostatin: Somatostatin may be used to suppress endogenous insulin secretion"
10945681|NCT00786825|OG001|Outcome|Healthy Controls|Healthy control subjects
10945682|NCT00786825|EG000|Reported Event|Somatostatin|"Type 1 diabetes and Hypoglycemia unawareness~somatostatin: Somatostatin may be used to suppress endogenous insulin secretion"
10945683|NCT00786825|EG001|Reported Event|Healthy Controls|Healthy control subjects
10945684|NCT00786838|BG000|Baseline|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
10945685|NCT00786838|FG000|Participant Flow|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
10945686|NCT00786838|OG000|Outcome|Placebo|Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
10945687|NCT00786838|OG001|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
10945688|NCT00786838|OG000|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
10945689|NCT00786838|OG000|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
10945690|NCT00786838|OG001|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
10945691|NCT00786838|OG000|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1.
10945692|NCT00786838|EG000|Reported Event|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
10945693|NCT00786864|BG000|Baseline|Exercise Intervention Group|Experimental Group
10945694|NCT00786864|BG001|Baseline|Control Group|Control group - no intervention
10945695|NCT00786864|BG002|Baseline|Total|Total of all reporting groups
10945696|NCT00786864|FG000|Participant Flow|Exercise Intervention Group|Experimental Group
10945697|NCT00786864|FG001|Participant Flow|Control Group|Control group - no intervention
10945698|NCT00786864|OG000|Outcome|Exercise Intervention Group|Experimental Group
11177572|NCT02041923|FG001|Participant Flow|H-HOPE Intervention|"H-HOPE was administered twice daily by the mother.~H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants."
11177573|NCT02041923|OG000|Outcome|Attention Control|Mothers received equal amount of attention from the team.
11177574|NCT02041923|OG001|Outcome|H-HOPE Intervention|"H-HOPE was administered twice daily by the mother.~H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants."
11177575|NCT02041923|OG000|Outcome|Attention Control|"Mothers received equal amount of attention from the team~H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants."
11341693|NCT03687372|OG000|Outcome|Hydrogen Peroxide 45% A-101|Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
10945699|NCT00786864|OG001|Outcome|Control Group|Control group - no intervention
10945700|NCT00786864|EG000|Reported Event|Exercise Intervention Group|Experimental Group
10945701|NCT00786864|EG001|Reported Event|Control Group|Control group - no intervention
10945702|NCT00786916|BG000|Baseline|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945703|NCT00786916|BG001|Baseline|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945704|NCT00786916|BG002|Baseline|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945705|NCT00786916|BG003|Baseline|Total|Total of all reporting groups
10945706|NCT00786916|FG000|Participant Flow|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945707|NCT00786916|FG001|Participant Flow|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945708|NCT00786916|FG002|Participant Flow|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945709|NCT00786916|OG000|Outcome|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945710|NCT00786916|OG001|Outcome|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945711|NCT00786916|OG002|Outcome|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
10945712|NCT00786916|EG000|Reported Event|Group A|Placebo (Saline) Group
10945713|NCT00786916|EG001|Reported Event|Group B|0.25 mg/kg Lidocaine Group
10945714|NCT00786916|EG002|Reported Event|Group C|0.50 mg/kg Lidocaine Group
10945715|NCT00786994|BG000|Baseline|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)~Oleogel-S10: topical use once or twice daily"
10945716|NCT00786994|BG001|Baseline|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)~Oleogel-S10: topical use once or twice daily"
10945717|NCT00786994|BG002|Baseline|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)~Placebo (petroleum jelly)"
10945718|NCT00786994|BG003|Baseline|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)~Placebo (petroleum jelly)"
10945719|NCT00786994|BG004|Baseline|Total|Total of all reporting groups
10945720|NCT00786994|FG000|Participant Flow|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)~Oleogel-S10: topical use once or twice daily"
10945721|NCT00786994|FG001|Participant Flow|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)~Oleogel-S10: topical use once or twice daily"
10945722|NCT00786994|FG002|Participant Flow|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)~Placebo (petroleum jelly)"
10945723|NCT00786994|FG003|Participant Flow|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)~Placebo (petroleum jelly)"
10945724|NCT00786994|OG000|Outcome|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day~Oleogel-S10: topical use once or twice daily"
10945725|NCT00786994|OG001|Outcome|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day~Oleogel-S10: topical use once or twice daily"
10945726|NCT00786994|OG002|Outcome|C/D - Placebo Once or Twice Daily|"Placebo (petroleum jelly) for three months once or twice a day~Placebo (petroleum jelly)"
10945727|NCT00786994|EG000|Reported Event|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day~Oleogel-S10: topical use once or twice daily"
10945728|NCT00786994|EG001|Reported Event|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day~Oleogel-S10: topical use once or twice daily"
10945729|NCT00786994|EG002|Reported Event|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day~Placebo (petroleum jelly)"
10945730|NCT00786994|EG003|Reported Event|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day~Placebo (petroleum jelly)"
10945731|NCT00787020|BG000|Baseline|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
10945732|NCT00787020|BG001|Baseline|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
10945733|NCT00787020|BG002|Baseline|Total|Total of all reporting groups
10945734|NCT00787020|FG000|Participant Flow|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
10945735|NCT00787020|FG001|Participant Flow|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
10945736|NCT00787020|OG000|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
10945737|NCT00787020|OG001|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
10945738|NCT00787020|EG000|Reported Event|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
10945739|NCT00787020|EG001|Reported Event|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
10945740|NCT00787137|BG000|Baseline|PG102 0.3 mg/kg|Lowest dose PG102
10945741|NCT00787137|BG001|Baseline|PG102 1 mg/kg|Second dose PG102
10945742|NCT00787137|BG002|Baseline|Placebo|Control, phosphate-buffered saline
10945743|NCT00787137|BG003|Baseline|Total|Total of all reporting groups
10945744|NCT00787137|FG000|Participant Flow|PG102 0.3 mg/kg|Lowest dose PG102
10945745|NCT00787137|FG001|Participant Flow|PG102 1 mg/kg|Second dose PG102
10945746|NCT00787137|FG002|Participant Flow|Placebo|Control, phosphate-buffered saline
10945747|NCT00787137|OG000|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
10945748|NCT00787137|OG001|Outcome|PG102 1 mg/kg|Second dose PG102
10945749|NCT00787137|OG002|Outcome|Placebo|Control, phosphate-buffered saline
10945750|NCT00787137|EG000|Reported Event|PG102 0.3 mg/kg|Lowest dose PG102
10945751|NCT00787137|EG001|Reported Event|PG102 1 mg/kg|Second dose PG102
10945752|NCT00787137|EG002|Reported Event|Placebo|Control, phosphate-buffered saline
10945753|NCT00787150|BG000|Baseline|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
10945754|NCT00787150|BG001|Baseline|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945755|NCT00787150|BG002|Baseline|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945756|NCT00787150|BG003|Baseline|Total|Total of all reporting groups
10945757|NCT00787150|FG000|Participant Flow|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
10945758|NCT00787150|FG001|Participant Flow|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945759|NCT00787150|FG002|Participant Flow|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945760|NCT00787150|OG000|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
10945761|NCT00787150|OG001|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945762|NCT00787150|OG002|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945763|NCT00787150|OG000|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945764|NCT00787150|OG001|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945765|NCT00787150|EG000|Reported Event|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
10945766|NCT00787150|EG001|Reported Event|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945767|NCT00787150|EG002|Reported Event|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
10945768|NCT00787189|BG000|Baseline|Active|Active laser device
10945769|NCT00787189|BG001|Baseline|Control|Placebo laser device
10945770|NCT00787189|BG002|Baseline|Total|Total of all reporting groups
10945771|NCT00787189|FG000|Participant Flow|Active|Active laser device
10945772|NCT00787189|FG001|Participant Flow|Control|Placebo laser device
10945773|NCT00787189|OG000|Outcome|Active|Active laser device
10945774|NCT00787189|OG001|Outcome|Control|Placebo laser device
10945775|NCT00787189|EG000|Reported Event|Active|Active laser device
10945776|NCT00787189|EG001|Reported Event|Control|Placebo laser device
10945777|NCT00787202|BG000|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
10945778|NCT00787202|BG001|Baseline|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
10945779|NCT00787202|BG002|Baseline|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
10945780|NCT00787202|BG003|Baseline|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
10945781|NCT00787202|BG004|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
10945782|NCT00787202|BG005|Baseline|Total|Total of all reporting groups
10945783|NCT00787202|FG000|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
10945784|NCT00787202|FG001|Participant Flow|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 milligram (mg) orally twice daily for 8 weeks.
10945785|NCT00787202|FG002|Participant Flow|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
10945786|NCT00787202|FG003|Participant Flow|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
10945787|NCT00787202|FG004|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
10945788|NCT00787202|OG000|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
10945789|NCT00787202|OG001|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
10945790|NCT00787202|OG002|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
10945791|NCT00787202|OG003|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
10945792|NCT00787202|OG004|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
10945793|NCT00787202|OG000|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
10945794|NCT00787202|OG001|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
10945795|NCT00787202|OG002|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
10945796|NCT00787202|OG003|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
10945797|NCT00787202|EG000|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
10945798|NCT00787202|EG001|Reported Event|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
10945799|NCT00787202|EG002|Reported Event|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
10945800|NCT00787202|EG003|Reported Event|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
10945801|NCT00787202|EG004|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
10945802|NCT00787241|BG000|Baseline|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
10945803|NCT00787241|BG001|Baseline|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
10945804|NCT00787241|BG002|Baseline|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
10945805|NCT00787241|BG003|Baseline|Total|Total of all reporting groups
10945806|NCT00787241|FG000|Participant Flow|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
10945807|NCT00787241|FG001|Participant Flow|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
10945808|NCT00787241|FG002|Participant Flow|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
10945809|NCT00787241|OG000|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
10945810|NCT00787241|OG001|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
10945811|NCT00787241|OG002|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
10945812|NCT00787241|EG000|Reported Event|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
10945813|NCT00787241|EG001|Reported Event|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
10945814|NCT00787241|EG002|Reported Event|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
10945815|NCT00787254|BG000|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
10945816|NCT00787254|BG001|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
10945817|NCT00787254|BG002|Baseline|Total|Total of all reporting groups
10945818|NCT00787254|FG000|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
10945819|NCT00787254|FG001|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
10945820|NCT00787254|OG000|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
10945821|NCT00787254|OG001|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
10945822|NCT00787254|EG000|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
10945823|NCT00787254|EG001|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
10945824|NCT00787267|BG000|Baseline|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
10945825|NCT00787267|FG000|Participant Flow|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
10945826|NCT00787267|OG000|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
10945827|NCT00787267|EG000|Reported Event|Evalulable Patients That Received Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
10945828|NCT00787319|BG000|Baseline|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
10945829|NCT00787319|FG000|Participant Flow|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
10945830|NCT00787319|OG000|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
10945831|NCT00787319|EG000|Reported Event|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
10945832|NCT00787332|BG000|Baseline|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
10945833|NCT00787332|BG001|Baseline|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
10945834|NCT00787332|BG002|Baseline|Total|Total of all reporting groups
10945835|NCT00787332|FG000|Participant Flow|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
10945836|NCT00787332|FG001|Participant Flow|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
10945837|NCT00787332|OG000|Outcome|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
10945838|NCT00787332|OG001|Outcome|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
10945839|NCT00787332|EG000|Reported Event|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
10945840|NCT00787332|EG001|Reported Event|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
10945841|NCT00787527|BG000|Baseline|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Zolinza (vorinostat) : Starting oral dose (Schedule A) of 300 mg once a day on Days 5-14 of 21 day cycle.~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
10945842|NCT00787527|FG000|Participant Flow|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin: 50 mg/m^2 by vein/intravenous (IV) over 15 minutes on Day 1 of 21 day cycle~Prednisone: 100 mg tablets by mouth/orally (PO) once a day on Days 1-5 of 21 day cycle~Zolinza (vorinostat): Phase I Starting dose of 300 mg by mouth each evening on Days 5-14 of 21 day cycle.~Cyclophosphamide: 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
10945843|NCT00787527|OG000|Outcome|Schedule A - Vorinostat Once or Twice Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle or Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
10945844|NCT00787527|OG000|Outcome|Schedule A - Vorinostat Once Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
10945845|NCT00787527|OG001|Outcome|Schedule A - Vorinostat Twice Daily|"Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
11341694|NCT03687372|OG001|Outcome|Isopropyl Alcohol and Water Vehicle|Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
10945846|NCT00787527|OG000|Outcome|Schedule B - Vorinostat Three Times Daily|"Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) of 21 day cycle.~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
10945847|NCT00787527|EG000|Reported Event|Schedule A: Vorinostat Once or Twice Daily|"Phase I: Vorinostat administered Days 5 to 14 at starting dose 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), next administered dose 200 mg orally twice daily (4000 mg over 10 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
10945848|NCT00787527|EG001|Reported Event|Schedule B: Vorinostat Three Times Daily|"Phase II: Vorinostat administered at starting dose 300 mg orally three times daily from Days -2 to 3 (4500 mg over 5 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
10945849|NCT00787566|BG000|Baseline|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
10945850|NCT00787566|BG001|Baseline|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
10945851|NCT00787566|BG002|Baseline|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
10945852|NCT00787566|BG003|Baseline|Total|Total of all reporting groups
10945853|NCT00787566|FG000|Participant Flow|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
10945854|NCT00787566|FG001|Participant Flow|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
10945855|NCT00787566|FG002|Participant Flow|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
10945856|NCT00787566|OG000|Outcome|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
10945857|NCT00787566|OG001|Outcome|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
10945858|NCT00787566|OG002|Outcome|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
10945859|NCT00787566|EG000|Reported Event|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
10945860|NCT00787566|EG001|Reported Event|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
10945861|NCT00787566|EG002|Reported Event|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
10945862|NCT00787605|BG000|Baseline|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
10945863|NCT00787605|BG001|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
10945864|NCT00787605|BG002|Baseline|Total|Total of all reporting groups
10945865|NCT00787605|FG000|Participant Flow|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
10945866|NCT00787605|FG001|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
10945867|NCT00787605|OG000|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
10945868|NCT00787605|OG001|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
10945869|NCT00787605|EG000|Reported Event|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
10945870|NCT00787605|EG001|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
10945871|NCT00787644|BG000|Baseline|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
10945872|NCT00787644|BG001|Baseline|2. Placebo|Placebo: Matching placebo (inert tablet)
10945873|NCT00787644|BG002|Baseline|Total|Total of all reporting groups
10945874|NCT00787644|FG000|Participant Flow|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
10945875|NCT00787644|FG001|Participant Flow|2. Placebo|Placebo: Matching placebo (inert tablet)
10945876|NCT00787644|OG000|Outcome|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
10945877|NCT00787644|OG001|Outcome|2. Placebo|Placebo: Matching placebo (inert tablet)
10945878|NCT00787644|EG000|Reported Event|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
10945879|NCT00787644|EG001|Reported Event|2. Placebo|Placebo: Matching placebo (inert tablet)
10945880|NCT00787722|BG000|Baseline|Hematopoietic Stem Cell Transplantation|"Hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide, G-CSF, Mesna, rATG, rituximab, and methylprednisolone.~Hematopoietic Stem Cell Transplantation: Infusion of participant's own stem cells~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~rATG: A rabbit polyclonal antibody to lymphocytes~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation"
10963622|NCT00873041|OG002|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
11341695|NCT03687372|OG000|Outcome|Hydrogen Peroxide 45% A-101|"topical solution~A-101: hydrogen peroxide topical solution 45%"
10945881|NCT00787722|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|"Hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide, G-CSF, Mesna, rATG, rituximab, and methylprednisolone.~Hematopoietic Stem Cell Transplantation: Infusion of participant's own stem cells~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~rATG: A rabbit polyclonal antibody to lymphocytes~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation"
10945882|NCT00787722|OG000|Outcome|Hematopoietic Stem Cell Transplantation|"Hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide, G-CSF, Mesna, rATG, rituximab, and methylprednisolone.~Hematopoietic Stem Cell Transplantation: Infusion of participant's own stem cells~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~rATG: A rabbit polyclonal antibody to lymphocytes~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation"
10945883|NCT00787722|OG000|Outcome|Hematopoietic Stem Cell Transplantation (HSCT)|"Hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide, G-CSF, Mesna, rATG, rituximab, and methylprednisolone.~Hematopoietic Stem Cell Transplantation: Infusion of participant's own stem cells~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~rATG: A rabbit polyclonal antibody to lymphocytes~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation"
10945884|NCT00787722|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|"Hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide, G-CSF, Mesna, rATG, rituximab, and methylprednisolone.~Hematopoietic Stem Cell Transplantation: Infusion of participant's own stem cells~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~rATG: A rabbit polyclonal antibody to lymphocytes~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation"
10945885|NCT00787761|BG000|Baseline|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
10945886|NCT00787761|FG000|Participant Flow|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
10945887|NCT00787761|OG000|Outcome|Transplant Recipients|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol
10945888|NCT00787761|OG000|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
10945889|NCT00787761|OG000|Outcome|Severe Graft Versus Host Disease|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol and who had severe graft versus host disease as a post-transplant complication
10945890|NCT00787761|EG000|Reported Event|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
11177576|NCT02041923|OG000|Outcome|Attention Control|"Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.~Attention Control: Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care."
10945891|NCT00787787|BG000|Baseline|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
10945892|NCT00787787|FG000|Participant Flow|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
11177577|NCT02041923|EG000|Reported Event|Attention Control|"Mothers received equal amount of attention from the team~H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants."
11177578|NCT02041923|EG001|Reported Event|H-HOPE Intervention|"H-HOPE was administered twice daily by the mother.~H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants."
10945893|NCT00787787|OG000|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
10945894|NCT00787787|EG000|Reported Event|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
10945895|NCT00787800|BG000|Baseline|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
10945896|NCT00787800|BG001|Baseline|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
10945897|NCT00787800|BG002|Baseline|Total|Total of all reporting groups
10945898|NCT00787800|FG000|Participant Flow|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
10945899|NCT00787800|FG001|Participant Flow|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
10945900|NCT00787800|OG000|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
10945901|NCT00787800|OG001|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
11177579|NCT02041962|BG000|Baseline|Educational Control|"Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.~Educational Control"
11240729|NCT02481375|EG000|Reported Event|Multiple Micronutrients With Iron|"Multiple micronutrient formulations were based on the UNICEF/WHO/UNU standard formulation for pregnant and lactating women (UNIMMAP) with increased iron (from 30 mg to 60 mg elemental iron) for comparability to the iron only group (60 mg). This formulation has 15 micronutrients including iron.~Women will receive the multiple micronutrient with iron for 12 weeks.~Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine~Iron: 12-wk supplementation of iron"
10945902|NCT00787800|OG000|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
10945903|NCT00787800|EG000|Reported Event|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
10945904|NCT00787800|EG001|Reported Event|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
10945905|NCT00787839|BG000|Baseline|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.
10945906|NCT00787839|FG000|Participant Flow|Group 1|"Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.~Glucose challenge test: At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.~Glucose tolerance test: Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c."
10945907|NCT00787839|OG000|Outcome|GCTpl - Diabetes|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
10945908|NCT00787839|OG001|Outcome|GCTcap - Diabetes|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
10945909|NCT00787839|OG002|Outcome|RPG - Diabetes|random plasma glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
10945910|NCT00787839|OG003|Outcome|RCG - Diabetes|random capillary glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
10945911|NCT00787839|OG004|Outcome|A1c - Diabetes|hemoglobin A1c, measured at the time of the OGTT
10945912|NCT00787839|OG005|Outcome|GCTpl - Dysglycemia|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
10945913|NCT00787839|OG006|Outcome|GCTcap - Dysglycemia|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
10945914|NCT00787839|OG007|Outcome|RPG - Dysglycemia|random plasma glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
10945915|NCT00787839|OG008|Outcome|RCG - Dysglycemia|random capillary glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
10945916|NCT00787839|OG009|Outcome|A1c - Dysglycemia|hemoglobin A1c, measured at the time of the OGTT
10945917|NCT00787839|OG000|Outcome|GCTpl - Diabetes - VA|VA costs per case of diabetes identified, using the GCTpl screening test
10945918|NCT00787839|OG001|Outcome|GCTcap - Diabetes - VA|VA costs per case of diabetes identified, using the GCTcap screening test
10945919|NCT00787839|OG002|Outcome|GCTpl - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTpl screening test
10945920|NCT00787839|OG003|Outcome|GCTcap - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTcap screening test
10945921|NCT00787839|OG004|Outcome|GCTpl - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTpl screening test
10945922|NCT00787839|OG005|Outcome|GCTcap - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTcap screening test
10945923|NCT00787839|OG006|Outcome|GCTpl - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTpl screening test
11177580|NCT02041962|BG001|Baseline|Chronic Care Model for Mood Disorders|"Life Goals Collaborative Care~Chronic Care Model for Mood Disorders: The mood disorders CCM intervention (Life Goals Collaborative Care) consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session."
10945924|NCT00787839|OG007|Outcome|GCTcap - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTcap screening test
11177581|NCT02041962|BG002|Baseline|Total|Total of all reporting groups
11341696|NCT03687372|OG001|Outcome|Isopropyl Alcohol and Water Vehicle|"topical solution~vehicle: vehicle as a topical solution"
10945925|NCT00787839|EG000|Reported Event|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, the American Diabetes Association, and the National Institutes of Health
10945926|NCT00787852|BG000|Baseline|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
10945927|NCT00787852|BG001|Baseline|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,~Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
10945928|NCT00787852|BG002|Baseline|Total|Total of all reporting groups
10945929|NCT00787852|FG000|Participant Flow|Group 1: Dasatinib 50mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43~Dasatinib is to be taken 1x daily 50 mg daily~Maintenance x 2 years*"
10945930|NCT00787852|FG001|Participant Flow|Group 2: Dasatinib 70mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43~Dasatinib is to be taken 1x daily 70 mg daily~Maintenance x 2 years*"
10945931|NCT00787852|OG000|Outcome|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
10945932|NCT00787852|OG001|Outcome|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,~Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
10945933|NCT00787852|EG000|Reported Event|Group 1|DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily 50 mg daily
10945934|NCT00787852|EG001|Reported Event|Group 2|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~70 mg daily"
10945935|NCT00787891|BG000|Baseline|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945936|NCT00787891|BG001|Baseline|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945937|NCT00787891|BG002|Baseline|Total|Total of all reporting groups
10945938|NCT00787891|FG000|Participant Flow|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945939|NCT00787891|FG001|Participant Flow|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945940|NCT00787891|OG000|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945941|NCT00787891|OG001|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945942|NCT00787891|EG000|Reported Event|Rabeprazole 0.5 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945943|NCT00787891|EG001|Reported Event|Rabeprazole 1.0 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945944|NCT00787891|EG002|Reported Event|Rabeprazole 0.5 mg/kg (Double-blind Maintenance Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945945|NCT00787891|EG003|Reported Event|Rabeprazole 1.0 mg/kg (Double-blind Maintenance Phase|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
10945946|NCT00787904|BG000|Baseline|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
10945947|NCT00787904|BG001|Baseline|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
10945948|NCT00787904|BG002|Baseline|Total|Total of all reporting groups
10945949|NCT00787904|FG000|Participant Flow|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
10945950|NCT00787904|FG001|Participant Flow|Surgical Control|Pre-menopausal women with or without surgery
10945951|NCT00787904|OG000|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
10945952|NCT00787904|OG001|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
10945953|NCT00787904|EG000|Reported Event|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
11177582|NCT02041962|FG000|Participant Flow|Educational Control|"Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.~Educational Control"
11177583|NCT02041962|FG001|Participant Flow|Chronic Care Model for Mood Disorders|"Life Goals Collaborative Care~Chronic Care Model for Mood Disorders: The mood disorders CCM intervention (Life Goals Collaborative Care) consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session."
11177584|NCT02041962|OG000|Outcome|Educational Control|"Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.~Educational Control"
10945954|NCT00787904|EG001|Reported Event|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
10945955|NCT00787930|BG000|Baseline|Naturalistic Treatment|
10945956|NCT00787930|FG000|Participant Flow|Naturalistic Treatment|Acutely manic subjects were treated using the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) expert consensus guidelines beginning with valproic acid (titrated to therapeutic levels) over a three week period. If there was a non-response to this intervention, then a subject would continue acute treatment using other interventions indicated by STEP-BD protocols. After stabilization, subjects were followed monthly up to a year's duration and treated using the STEP-BD expert consensus guidelines.
10945957|NCT00787930|OG000|Outcome|Responders to Acute Treatment|Subjects in an acute manic episode who responded to treatment as measured by a Young Mania Rating Scale (YMRS) <15 by week 3, which was the protocol-defined determination point for response to treatment.
10945958|NCT00787930|OG001|Outcome|Non-Responders to Acute Treatment|Subjects in an acute manic episode who did not respond to treatment as measured by a YMRS >15 by week 3.
10945959|NCT00787930|OG000|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
10945960|NCT00787930|OG001|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
10945961|NCT00787930|OG000|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
10945962|NCT00787930|OG001|Outcome|Non-relapse Into Depression or Mania|"Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) <15 or Montgomery Asberg Depression Rating Scale (MADRS) scales <15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
10963623|NCT00873041|OG000|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10945963|NCT00787930|OG001|Outcome|Non-relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
10945964|NCT00787930|EG000|Reported Event|Naturalistic Treatment|Patients were treated acutely using expert consensus guidelines beginning with valproic acid. After stabilization, subjects were followed monthly up to a year's duration and treated using expert consensus guidelines. indicated.
10945965|NCT00787943|BG000|Baseline|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
10945966|NCT00787943|FG000|Participant Flow|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
10945967|NCT00787943|OG000|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
10945968|NCT00787943|OG001|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
11177585|NCT02041962|OG001|Outcome|Chronic Care Model for Mood Disorders|"Life Goals Collaborative Care~Chronic Care Model for Mood Disorders: The mood disorders CCM intervention (Life Goals Collaborative Care) consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session."
11177586|NCT02041962|EG000|Reported Event|Educational Control|"Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.~Educational Control"
11177587|NCT02041962|EG001|Reported Event|Chronic Care Model for Mood Disorders|"Life Goals Collaborative Care~Chronic Care Model for Mood Disorders: The mood disorders CCM intervention (Life Goals Collaborative Care) consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session."
11177588|NCT02042014|BG000|Baseline|QTI571|Participants received QTI571 during 3 years.
11177589|NCT02042014|FG000|Participant Flow|QTI571|Participants received QTI571 during 3 years
11177590|NCT02042014|OG000|Outcome|QTI571|Participants will receive QTI571 during 3 years.
11177591|NCT02042014|EG000|Reported Event|QTI571|QTI571
11177592|NCT02042131|BG000|Baseline|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
11177593|NCT02042131|BG001|Baseline|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)"
11177594|NCT02042131|BG002|Baseline|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)~Enhanced Crisis Response Plan (E-CRP)"
11177595|NCT02042131|BG003|Baseline|Total|Total of all reporting groups
11177596|NCT02042131|FG000|Participant Flow|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
11177597|NCT02042131|FG001|Participant Flow|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)"
11177598|NCT02042131|FG002|Participant Flow|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)~Enhanced Crisis Response Plan (E-CRP)"
11177599|NCT02042131|OG000|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
11177600|NCT02042131|OG001|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Standard Crisis Response Plan (S-CRP)~Enhanced Crisis Response Plan (E-CRP)"
11341697|NCT03687372|EG000|Reported Event|Active|Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
10945969|NCT00787943|OG002|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
10945970|NCT00787943|OG003|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
10945971|NCT00787943|EG000|Reported Event|Benzoyl Peroxide 10.0% Cream Formulation #1|Formulation #1 applied to one side of the face by all 10 subjects.
10945972|NCT00787943|EG001|Reported Event|Benzoyl Peroxide 10.0% Cream: Formulation #2|Formulation #2 applied to one side of the face by all 10 subjects.
10945973|NCT00788008|BG000|Baseline|Isoflurane|Inhalational anesthesia with isoflurane
10945974|NCT00788008|BG001|Baseline|Propofol|Total intravenous anesthesia with propofol
11177601|NCT02042131|OG002|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Enhanced Crisis Response Plan (E-CRP)"
11177602|NCT02042131|OG001|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (S-CRP)"
11177603|NCT02042131|OG002|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (S-CRP)~Enhanced Crisis Response Plan (E-CRP)"
11177604|NCT02042131|EG000|Reported Event|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
10945975|NCT00788008|BG002|Baseline|Total|Total of all reporting groups
10945976|NCT00788008|FG000|Participant Flow|Isoflurane|Inhalational anesthesia with isoflurane
10945977|NCT00788008|FG001|Participant Flow|Propofol|Total intravenous anesthesia with propofol
10945978|NCT00788008|OG000|Outcome|Isoflurane|Inhalational anesthesia with isoflurane
10945979|NCT00788008|OG001|Outcome|Propofol|Total intravenous anesthesia with propofol
10945980|NCT00788008|EG000|Reported Event|Isoflurane|Inhalational anesthesia with isoflurane
10945981|NCT00788008|EG001|Reported Event|Propofol|Total intravenous anesthesia with propofol
10945982|NCT00788073|BG000|Baseline|STX209|STX209 Variable dose, 1mg bid to 10mg tid, oral capsules, 4weeks
10945983|NCT00788073|BG001|Baseline|Placebo|placebo variable dose (same flexible dose titration protocol) bid to tid, oral, 4weeks
10945984|NCT00788073|BG002|Baseline|Total|Total of all reporting groups
10945985|NCT00788073|FG000|Participant Flow|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
10945986|NCT00788073|FG001|Participant Flow|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
10945987|NCT00788073|OG000|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
10945988|NCT00788073|OG001|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
10945989|NCT00788073|EG000|Reported Event|STX209|STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks
10945990|NCT00788073|EG001|Reported Event|Placebo|variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
10945991|NCT00788255|BG000|Baseline|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
10945992|NCT00788255|FG000|Participant Flow|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
10945993|NCT00788255|OG000|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
10945994|NCT00788255|EG000|Reported Event|22.5 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
10945995|NCT00788255|EG001|Reported Event|30.1 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
10945996|NCT00788255|EG002|Reported Event|32.9 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
10945997|NCT00788255|EG003|Reported Event|0 μU/mL Exogenous Oxytocin|Thromboelastography on native blood sample.
10945998|NCT00788372|BG000|Baseline|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
10945999|NCT00788372|FG000|Participant Flow|Fentanyl|Fentanyl transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
10946000|NCT00788372|OG000|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
10946001|NCT00788372|EG000|Reported Event|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
10946002|NCT00788593|BG000|Baseline|Entire Study Population|Includes participants who received placebo, EUR-1008 (APT-1008) high dose first and EUR-1008 (APT-1008) low dose first.
10946003|NCT00788593|FG000|Participant Flow|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
10946004|NCT00788593|FG001|Participant Flow|EUR-1008 (APT-1008) High Dose, Then Low Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
10946005|NCT00788593|FG002|Participant Flow|EUR-1008 (APT-1008) Low Dose, Then High Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
10946006|NCT00788593|OG000|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
10946007|NCT00788593|OG001|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
10946008|NCT00788593|OG000|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
10946009|NCT00788593|OG001|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
10946010|NCT00788593|OG002|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
10946011|NCT00788593|EG000|Reported Event|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
10946012|NCT00788593|EG001|Reported Event|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
10946013|NCT00788593|EG002|Reported Event|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
10946014|NCT00788697|BG000|Baseline|ITD Population|All patients who received SonoVue and enrolled in the efficacy phase, had a definite final diagnosis from truth standard and unenhanced and SonoVue-enhanced ultrasonography available
10946015|NCT00788697|FG000|Participant Flow|Safety Population|"Interventions included SonoVue administration, unenhanced and SonoVue-enhanced ultrasound and definitive truth standard diagnosis.~Any patient who received SonoVue, training or efficacy phase, regardless of availability of ultrasonography or truth standard, is included in the Safety Population. Twelve patients with No study drug administered are not included in the Safety Population.~From 337 patients in the Safety Population, 74 patients enrolled in the training phase were excluded from efficacy analysis, and the Completed patients include efficacy phase patients who underwent SonoVue-enhanced ultrasound (SonoVue CE-US), unenhanced ultrasound (UE-US),and had definite truth standard diagnosis available."
10946016|NCT00788697|OG000|Outcome|Offsite Reader 1 - UE-US|Offsite Reader 1 unenhanced (UE) US assessment
10946017|NCT00788697|OG001|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
10946018|NCT00788697|OG002|Outcome|Offsite Reader 2 - UE-US|Offsite Reader 2 UE-US assessment
10946019|NCT00788697|OG003|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
10946020|NCT00788697|OG004|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
10946021|NCT00788697|OG005|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
10946022|NCT00788697|OG000|Outcome|Offsite Reader 1 - UE-US|Offsite Reader 1 UE-US assessment
10946023|NCT00788697|OG000|Outcome|UE-US|UE-US Inter-reader agreement
10946024|NCT00788697|OG001|Outcome|CE-US|CE-US Inter-reader agreement
10946025|NCT00788697|EG000|Reported Event|Safety Population|"Interventions included SonoVue administration, unenhanced and SonoVue-enhanced ultrasound and definitive truth standard diagnosis.~Any patient who received SonoVue, training or efficacy phase, regardless of availability of ultrasonography or truth standard, is included in the Safety Population. Twelve patients with No study drug administered are not included in the Safety Population.~Of 349 patients who started the study, 12 patients had No study drug administered and are not included and 337 received SonoVue and are included in the Safety Population."
10946026|NCT00788775|BG000|Baseline|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
10946027|NCT00788775|BG001|Baseline|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
10946028|NCT00788775|BG002|Baseline|Total|Total of all reporting groups
10946029|NCT00788775|FG000|Participant Flow|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
10946030|NCT00788775|FG001|Participant Flow|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
10946031|NCT00788775|OG000|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
10946032|NCT00788775|OG001|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
10946033|NCT00788775|EG000|Reported Event|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
10946034|NCT00788775|EG001|Reported Event|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
10946035|NCT00788827|BG000|Baseline|Single Arm|Autologous CD34+ Stem Cells
10946036|NCT00788827|FG000|Participant Flow|Autologous CD34+ Stem Cells|"Up to 5 x 10 log 8 of autologous stem cells on a single occasion~Autologous CD34+ stem cells: Up to 5 x 10 log 8 of autologous stem cells on a single occasion"
10946037|NCT00788827|OG000|Outcome|Autologous Stem Cells|"Up to 5 x 10 log 8 of autologous stem cells on a single occasion~Autologous CD34+ stem cells: Up to 5 x 10 log 8 of autologous stem cells on a single occasion"
10946038|NCT00788827|OG000|Outcome|Pre Infusion of Stem Cells|Before the infusion of stem cells
10946039|NCT00788827|OG001|Outcome|Post Infusion of Stem Cells|After the infusion of stem cells
10946040|NCT00788827|EG000|Reported Event|Single Arm|Autologous stem cells
10946041|NCT00788892|BG000|Baseline|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
10946042|NCT00788892|BG001|Baseline|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
10946043|NCT00788892|BG002|Baseline|Total|Total of all reporting groups
10946044|NCT00788892|FG000|Participant Flow|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
10946045|NCT00788892|FG001|Participant Flow|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
10946046|NCT00788892|OG000|Outcome|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
10946047|NCT00788892|OG001|Outcome|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
10946048|NCT00788892|EG000|Reported Event|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
10946049|NCT00788892|EG001|Reported Event|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
10946050|NCT00788957|BG000|Baseline|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946051|NCT00788957|BG001|Baseline|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
11177605|NCT02042131|EG001|Reported Event|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)"
10946052|NCT00788957|BG002|Baseline|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946053|NCT00788957|BG003|Baseline|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946054|NCT00788957|BG004|Baseline|Total|Total of all reporting groups
10946055|NCT00788957|FG000|Participant Flow|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946056|NCT00788957|FG001|Participant Flow|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946057|NCT00788957|FG002|Participant Flow|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946058|NCT00788957|FG003|Participant Flow|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946059|NCT00788957|FG004|Participant Flow|Part 3: Rilotumumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
10946060|NCT00788957|FG005|Participant Flow|Part 3: Ganitumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
10946061|NCT00788957|OG000|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946062|NCT00788957|OG000|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946063|NCT00788957|OG001|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946064|NCT00788957|OG002|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946065|NCT00788957|OG001|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946066|NCT00788957|OG002|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946067|NCT00788957|OG003|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946068|NCT00788957|OG000|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946069|NCT00788957|OG001|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946070|NCT00788957|OG000|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946071|NCT00788957|OG000|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946072|NCT00788957|EG000|Reported Event|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946073|NCT00788957|EG001|Reported Event|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946074|NCT00788957|EG002|Reported Event|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946075|NCT00788957|EG003|Reported Event|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
10946076|NCT00789035|BG000|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
10946077|NCT00789035|BG001|Baseline|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10946078|NCT00789035|BG002|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10946079|NCT00789035|BG003|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10946080|NCT00789035|BG004|Baseline|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
10946081|NCT00789035|BG005|Baseline|Total|Total of all reporting groups
10946082|NCT00789035|FG000|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
10946083|NCT00789035|FG001|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10946084|NCT00789035|FG002|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10946085|NCT00789035|FG003|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10946086|NCT00789035|FG004|Participant Flow|Metformin OL|Patients were to take a open-label (OL) dose of 500 mg Metformin twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
10946087|NCT00789035|OG000|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
10946088|NCT00789035|OG001|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10946089|NCT00789035|OG002|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10946090|NCT00789035|OG003|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10946091|NCT00789035|OG004|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
10946092|NCT00789035|OG000|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10946093|NCT00789035|OG001|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10946094|NCT00789035|OG002|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10946095|NCT00789035|EG000|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
10946096|NCT00789035|EG001|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
10946097|NCT00789035|EG002|Reported Event|Empagliflozin 10 mg qd|Patients receive 10 mg Empagliflozin in tablets once daily.
10946098|NCT00789035|EG003|Reported Event|Empagliflozin 25 mg qd|Patients receive 25 mg Empagliflozin in tablets once daily.
10946099|NCT00789035|EG004|Reported Event|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
10946100|NCT00789074|BG000|Baseline|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
10946101|NCT00789074|BG001|Baseline|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
10946102|NCT00789074|BG002|Baseline|Total|Total of all reporting groups
10946103|NCT00789074|FG000|Participant Flow|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
10946104|NCT00789074|FG001|Participant Flow|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
10946105|NCT00789074|OG000|Outcome|Varenicline|
10946106|NCT00789074|OG001|Outcome|Placebo|
10946107|NCT00789074|OG000|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
10946108|NCT00789074|OG001|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
10946109|NCT00789074|OG000|Outcome|Varenicline Pre-treatment|
11177606|NCT02042131|EG002|Reported Event|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)~Enhanced Crisis Response Plan (E-CRP)"
11177607|NCT02042183|BG000|Baseline|Lubiprostone|Participants receive lubiprostone BID up to 12 weeks
11177608|NCT02042183|BG001|Baseline|Placebo|Participants receive placebo BID up to 12 weeks
11177609|NCT02042183|BG002|Baseline|Total|Total of all reporting groups
11177610|NCT02042183|FG000|Participant Flow|Lubiprostone|Participants receive lubiprostone twice daily (BID)
10946110|NCT00789074|EG000|Reported Event|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
11177611|NCT02042183|FG001|Participant Flow|Placebo|Participants receive placebo BID up to 12 weeks
11177612|NCT02042183|OG000|Outcome|Lubiprostone|Participants receive lubiprostone BID for up to 12 weeks
11177613|NCT02042183|OG001|Outcome|Placebo|Participants receive placebo BID for up to 12 weeks.
10946111|NCT00789074|EG001|Reported Event|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
11177614|NCT02042183|OG000|Outcome|Lubiprostone|Participants receive lubiprostone BID up to 12 weeks
11177615|NCT02042183|OG001|Outcome|Placebo|Participants receive placebo BID up to 12 weeks
11177616|NCT02042183|EG000|Reported Event|Lubiprostone|Participants receive lubiprostone BID for up to 12 weeks
11177617|NCT02042183|EG001|Reported Event|Placebo|Participants received placebo BID for up to 12 weeks
11177618|NCT02042274|BG000|Baseline|Fish Oil|Fish oil supplements providing up to 3g per day of EPA and DHA, for 90 days.
11177619|NCT02042274|FG000|Participant Flow|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.~Measurements are made at three time points: Baseline (Day 0 - before beginning fish oil supplementation), 3 months (Day 90 - after fish oil supplementation), and 5 months (Day 150 - 2 month washout)."
11177620|NCT02042274|OG000|Outcome|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
11177621|NCT02042274|EG000|Reported Event|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
11177622|NCT02042404|BG000|Baseline|Mild to Severe Hearing Impairment|Subjects wearing the Earlens System in their daily lives.
11177623|NCT02042404|FG000|Participant Flow|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
10946112|NCT00789113|BG000|Baseline|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
11177624|NCT02042404|FG001|Participant Flow|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
10946113|NCT00789113|FG000|Participant Flow|Extended Release Lamotrigine|"Extended Release Lamotrigine~Extended Release Lamotrigine"
10946114|NCT00789113|OG000|Outcome|Immediate Release (IR) Lamotrigine|Study population was on chronic IR lamotrigine therapy and first period of the study was a continuation of standard treatment with IR lamotrigine.
10946115|NCT00789113|OG001|Outcome|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
11341698|NCT03687372|EG001|Reported Event|Vehicle|Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
10946116|NCT00789113|EG000|Reported Event|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
10946117|NCT00789191|BG000|Baseline|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
10946118|NCT00789191|BG001|Baseline|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
10946119|NCT00789191|BG002|Baseline|Total|Total of all reporting groups
10946120|NCT00789191|FG000|Participant Flow|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
10946121|NCT00789191|FG001|Participant Flow|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
10946122|NCT00789191|OG000|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
10946123|NCT00789191|OG001|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
10946124|NCT00789191|EG000|Reported Event|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
11177625|NCT02042404|OG000|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
11177626|NCT02042404|OG001|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
11177627|NCT02042404|OG000|Outcome|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
11177628|NCT02042404|OG000|Outcome|Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
11177629|NCT02042404|EG000|Reported Event|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
11177630|NCT02042443|BG000|Baseline|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11177631|NCT02042443|BG001|Baseline|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11177632|NCT02042443|BG002|Baseline|Total|Total of all reporting groups
11177633|NCT02042443|FG000|Participant Flow|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11177634|NCT02042443|FG001|Participant Flow|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11177635|NCT02042443|OG000|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10946125|NCT00789191|EG001|Reported Event|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
11177636|NCT02042443|OG001|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11177637|NCT02042443|OG000|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
11177638|NCT02042443|EG000|Reported Event|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10946126|NCT00789256|BG000|Baseline|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
11177639|NCT02042443|EG001|Reported Event|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11177640|NCT02042534|BG000|Baseline|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
11177641|NCT02042534|BG001|Baseline|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 - 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
11177642|NCT02042534|BG002|Baseline|Total|Total of all reporting groups
11341723|NCT03687684|FG005|Participant Flow|Japanese Cohort 4: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10946127|NCT00789256|BG001|Baseline|Strata 2|will include patients who have received prior medical intervention for their disease.
10946128|NCT00789256|BG002|Baseline|Total|Total of all reporting groups
10946129|NCT00789256|FG000|Participant Flow|Strata 1|Includes patients who have not seen prior medical intervention for their disease. Patients assigned to Strata 1 will receive Melphalan 2mg orally, once daily and Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.
11177643|NCT02042534|FG000|Participant Flow|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
11177644|NCT02042534|FG001|Participant Flow|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 - 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
11177645|NCT02042534|OG000|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
11177646|NCT02042534|OG001|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 - 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
11177647|NCT02042534|EG000|Reported Event|Rivaroxaban|"Safety population : 98 (patients)~Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
11177648|NCT02042534|EG001|Reported Event|Warfarin|"Safety population : 90 (patients)~Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 - 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
11177649|NCT02042872|BG000|Baseline|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
11177650|NCT02042872|BG001|Baseline|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
11177651|NCT02042872|BG002|Baseline|Total|Total of all reporting groups
11177652|NCT02042872|FG000|Participant Flow|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
11177653|NCT02042872|FG001|Participant Flow|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
11177654|NCT02042872|OG000|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
11177655|NCT02042872|OG001|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
11177656|NCT02042872|EG000|Reported Event|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
11177657|NCT02042872|EG001|Reported Event|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
11177658|NCT02042911|BG000|Baseline|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
11177659|NCT02042911|FG000|Participant Flow|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
11177660|NCT02042911|OG000|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
11341724|NCT03687684|FG006|Participant Flow|Japanese Cohort 5: TAK-831 50 mg|TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10946130|NCT00789256|FG001|Participant Flow|Strata 2|Includes patients who have received prior medical intervention for their disease. Patients assigned to Strata 2 will receive Melphalan 2mg orally, once daily and Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.
10946131|NCT00789256|OG000|Outcome|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
10946132|NCT00789256|OG001|Outcome|Strata 2|will include patients who have received prior medical intervention for their disease.
11177661|NCT02042911|EG000|Reported Event|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
11177662|NCT02043015|BG000|Baseline|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
11177663|NCT02043015|FG000|Participant Flow|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), men who have sex with men (MSM) and lesbian, gay, bisexual, and transgender (LGBT) sensitization training for staff and providers, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
11177664|NCT02043015|OG000|Outcome|Recipients of HIV Prevention Services|Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
11177665|NCT02043015|OG000|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
11177666|NCT02043015|OG000|Outcome|Health Care Providers|Health care providers in Cape Town who care for MSM populations.
11177667|NCT02043015|EG000|Reported Event|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV Testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
11177668|NCT02043132|BG000|Baseline|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
11177669|NCT02043132|BG001|Baseline|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
11177670|NCT02043132|BG002|Baseline|Total|Total of all reporting groups
11177671|NCT02043132|FG000|Participant Flow|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
11177672|NCT02043132|FG001|Participant Flow|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
11240730|NCT02481375|EG001|Reported Event|Multiple Micronutrients Without Iron|"This formulation has the 14 micronutrients included in the UNIMMAP formulation, but does not include iron.~Women will receive the multiple micronutrient without iron for 12 weeks.~Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine"
10946133|NCT00789256|OG000|Outcome|Study Treatment|"All patients will receive the following regimen: 1) Melphalan 2 mg orally, once daily. 2) Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.~Melphalan: Melphalan: 2mg orally, once daily~Bortezomib: Bortezomib: 1.0mg/M2 IV on days 1, 4, 8, 11~Melphalan and bortezomib"
10946134|NCT00789256|OG000|Outcome|Strata 1|Includes patients who have not seen prior medical intervention for their disease. Patients assigned to Strata 1 will receive Melphalan 2mg orally, once daily and Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.
10946135|NCT00789256|OG001|Outcome|Strata 2|Includes patients who have received prior medical intervention for their disease. Patients assigned to Strata 2 will receive Melphalan 2mg orally, once daily and Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.
10946136|NCT00789256|EG000|Reported Event|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
10946137|NCT00789256|EG001|Reported Event|Strata 2|will include patients who have received prior medical intervention for their disease.
10946138|NCT00789321|BG000|Baseline|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
10946139|NCT00789321|BG001|Baseline|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
10946140|NCT00789321|BG002|Baseline|Total|Total of all reporting groups
10946141|NCT00789321|FG000|Participant Flow|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
10946142|NCT00789321|FG001|Participant Flow|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
11192176|NCT02137512|EG000|Reported Event|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs - a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
10946143|NCT00789321|OG000|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
10946144|NCT00789321|OG001|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
10946145|NCT00789321|EG000|Reported Event|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
10946146|NCT00789321|EG001|Reported Event|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
10946147|NCT00789360|BG000|Baseline|Inhaled Placebo / Loxapine|Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
10946148|NCT00789360|BG001|Baseline|Inhaled Loxapine / Placebo|Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
10946149|NCT00789360|BG002|Baseline|Total|Total of all reporting groups
10946150|NCT00789360|FG000|Participant Flow|Inhaled Placebo / Loxapine|Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
10946151|NCT00789360|FG001|Participant Flow|Inhaled Loxapine / Placebo|Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
10946152|NCT00789360|OG000|Outcome|Inhaled Loxapine|Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
10946153|NCT00789360|OG001|Outcome|Inhaled Staccato Placebo|Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
10946154|NCT00789360|OG001|Outcome|Inhaled Staccato|Inhaled Staccato Placebo, 2 inhalation, 8 hours apart
10946155|NCT00789360|EG000|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo, 2 inhalations, 8 hours apart~Inhaled Placebo: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart"
10946156|NCT00789360|EG001|Reported Event|Inhaled Loxapine|"Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart~Inhaled Loxapine: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart"
10946157|NCT00789373|BG000|Baseline|Induction Pemetrexed + Cisplatin|pemetrexed plus cisplatin
10946158|NCT00789373|FG000|Participant Flow|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.~cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
10946159|NCT00789373|FG001|Participant Flow|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|Following Induction, received 500 mg/m^2 maintenance pemetrexed, IV, on Day 1 of each 21-day cycle plus Best Supportive Care until progressive disease (PD) or treatment discontinuation.
10946160|NCT00789373|FG002|Participant Flow|Pemetrexed + Cisplatin Followed by Placebo|Following Induction, received placebo (normal saline [0.9% sodium chloride]) administered IV on Day 1 of every 21-day cycle plus Best Supportive Care until PD or treatment discontinuation.
10946161|NCT00789373|OG000|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
10946162|NCT00789373|OG001|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
10946163|NCT00789373|OG001|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
10946164|NCT00789373|OG000|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
10946165|NCT00789373|OG001|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
10946166|NCT00789373|OG000|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed and best supportive care
10946167|NCT00789373|EG000|Reported Event|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.~cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
10946168|NCT00789373|EG001|Reported Event|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
10946169|NCT00789373|EG002|Reported Event|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
10946170|NCT00789438|BG000|Baseline|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
10946171|NCT00789438|BG001|Baseline|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
10946172|NCT00789438|BG002|Baseline|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
10946173|NCT00789438|BG003|Baseline|Total|Total of all reporting groups
10946174|NCT00789438|FG000|Participant Flow|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
10946175|NCT00789438|FG001|Participant Flow|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
10946176|NCT00789438|FG002|Participant Flow|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
10946177|NCT00789438|OG000|Outcome|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
10946178|NCT00789438|OG001|Outcome|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
10946179|NCT00789438|OG002|Outcome|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
10946180|NCT00789438|EG000|Reported Event|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
10946181|NCT00789438|EG001|Reported Event|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
10946182|NCT00789438|EG002|Reported Event|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
11192177|NCT02137538|BG000|Baseline|Letrozole|Participants receive letrozole 2.5 mg daily
11192178|NCT02137538|BG001|Baseline|Anastrozole|Participants receive anastrozole 1 mg daily
10946183|NCT00789477|BG000|Baseline|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
10946184|NCT00789477|BG001|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
10946185|NCT00789477|BG002|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
10946186|NCT00789477|BG003|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
10946187|NCT00789477|BG004|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
10946188|NCT00789477|BG005|Baseline|Total|Total of all reporting groups
10946189|NCT00789477|FG000|Participant Flow|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
10946190|NCT00789477|FG001|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
10946191|NCT00789477|FG002|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2 mg every 4 weeks to week 52
10946192|NCT00789477|FG003|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
10946193|NCT00789477|FG004|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria to week 52
10946194|NCT00789477|OG000|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
10946195|NCT00789477|OG001|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
10946196|NCT00789477|OG002|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
10946197|NCT00789477|OG003|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
10946198|NCT00789477|OG004|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
10946199|NCT00789477|OG001|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
10946200|NCT00789477|OG002|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
10946201|NCT00789477|EG000|Reported Event|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
10946202|NCT00789477|EG001|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
10946203|NCT00789477|EG002|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
10946204|NCT00789477|EG003|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
10946205|NCT00789477|EG004|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
10946206|NCT00789529|BG000|Baseline|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
10946207|NCT00789529|BG001|Baseline|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
10946208|NCT00789529|BG002|Baseline|Total|Total of all reporting groups
11192179|NCT02137538|BG002|Baseline|Total|Total of all reporting groups
11192180|NCT02137538|FG000|Participant Flow|Letrozole|Participants receive letrozole 2.5 mg daily
10946209|NCT00789529|FG000|Participant Flow|1 - ReNu MultiPlus First, Opti-Free RepleniSH Second|Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period
10946210|NCT00789529|FG001|Participant Flow|2 - Opti-Free RepleniSH First, ReNu MultiPlus Second|Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period
10946211|NCT00789529|OG000|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
10946212|NCT00789529|OG001|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
10946213|NCT00789529|EG000|Reported Event|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
10946214|NCT00789529|EG001|Reported Event|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
11177673|NCT02043132|OG000|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
11177674|NCT02043132|OG001|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
10946215|NCT00789555|BG000|Baseline|PATANASE|Two sprays in each nostril twice a day for up to 12 months
10946216|NCT00789555|BG001|Baseline|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
10946217|NCT00789555|BG002|Baseline|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
10946218|NCT00789555|BG003|Baseline|Total|Total of all reporting groups
10946219|NCT00789555|FG000|Participant Flow|PATANASE|Two sprays in each nostril twice a day for up to 12 months
10946220|NCT00789555|FG001|Participant Flow|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
10946221|NCT00789555|FG002|Participant Flow|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
10946222|NCT00789555|OG000|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
10946223|NCT00789555|OG001|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
10946224|NCT00789555|OG002|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
10946225|NCT00789555|EG000|Reported Event|PATANASE|Two sprays in each nostril twice a day for up to 12 months
10946226|NCT00789555|EG001|Reported Event|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
10946227|NCT00789555|EG002|Reported Event|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
10946228|NCT00789581|BG000|Baseline|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
10946229|NCT00789581|BG001|Baseline|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
10946230|NCT00789581|BG002|Baseline|Total|Total of all reporting groups
10946231|NCT00789581|FG000|Participant Flow|AC/Ixabepilone|"Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by ixabepilone every 3 weeks for 4 cycles (12 weeks).~Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2"
10946232|NCT00789581|FG001|Participant Flow|AC/Paclitaxel|"Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by weekly paclitaxel for 12 weeks.~Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2"
10946233|NCT00789581|OG000|Outcome|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
10946234|NCT00789581|OG001|Outcome|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
10946235|NCT00789581|OG001|Outcome|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
10946236|NCT00789581|EG000|Reported Event|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
10946237|NCT00789581|EG001|Reported Event|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
10946238|NCT00789672|BG000|Baseline|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
10946239|NCT00789672|BG001|Baseline|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
10946240|NCT00789672|BG002|Baseline|Total|Total of all reporting groups
10946241|NCT00789672|FG000|Participant Flow|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
10946242|NCT00789672|FG001|Participant Flow|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
10946243|NCT00789672|OG000|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
10946244|NCT00789672|OG001|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
10946245|NCT00789672|EG000|Reported Event|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
10946246|NCT00789672|EG001|Reported Event|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
10946247|NCT00789685|BG000|Baseline|Safety Population|Safety population includes all patients who received at least one dose of study medication, and was used for summaries of demographic and other baseline characteristics
10946248|NCT00789685|FG000|Participant Flow|Interferon Beta|"Interferon Beta~Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered."
10946249|NCT00789685|OG000|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
10946250|NCT00789685|EG000|Reported Event|Safety Population|Safety population includes all patients who received at least one dose of study medication
10946251|NCT00789698|BG000|Baseline|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
10946252|NCT00789698|BG001|Baseline|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
10946253|NCT00789698|BG002|Baseline|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
10946254|NCT00789698|BG003|Baseline|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
10946255|NCT00789698|BG004|Baseline|Total|Total of all reporting groups
10946256|NCT00789698|FG000|Participant Flow|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
10946257|NCT00789698|FG001|Participant Flow|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
10946258|NCT00789698|FG002|Participant Flow|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
10946259|NCT00789698|FG003|Participant Flow|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
10946260|NCT00789698|OG000|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
10946261|NCT00789698|OG001|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
10946262|NCT00789698|OG000|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or Lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
10946263|NCT00789698|EG000|Reported Event|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
10946264|NCT00789698|EG001|Reported Event|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
10946265|NCT00789698|EG002|Reported Event|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
10946266|NCT00789698|EG003|Reported Event|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
10946267|NCT00789724|BG000|Baseline|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
10946268|NCT00789724|BG001|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
10946269|NCT00789724|BG002|Baseline|Total|Total of all reporting groups
10946270|NCT00789724|FG000|Participant Flow|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
10946271|NCT00789724|FG001|Participant Flow|Placebo|0.67 ml of NaCl 0.9% solution
10946272|NCT00789724|OG000|Outcome|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
10946273|NCT00789724|OG001|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
10946274|NCT00789724|EG000|Reported Event|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
10946275|NCT00789724|EG001|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
10946276|NCT00789737|BG000|Baseline|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
10946277|NCT00789737|BG001|Baseline|Placebo|"placebo~Placebo : placebo"
10946278|NCT00789737|BG002|Baseline|Total|Total of all reporting groups
10946279|NCT00789737|FG000|Participant Flow|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
10946280|NCT00789737|FG001|Participant Flow|Placebo|"placebo~Placebo : placebo"
10946281|NCT00789737|OG000|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
10946282|NCT00789737|OG001|Outcome|Placebo|"placebo~Placebo : placebo"
10946283|NCT00789737|EG000|Reported Event|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
10946284|NCT00789737|EG001|Reported Event|Placebo|"placebo~Placebo : placebo"
10946285|NCT00789750|BG000|Baseline|Colesevelam|Colesevelam tablets with pioglitazone therapy
10946286|NCT00789750|BG001|Baseline|Placebo|Placebo tablets with pioglitazone therapy
10946287|NCT00789750|BG002|Baseline|Total|Total of all reporting groups
10946288|NCT00789750|FG000|Participant Flow|Colesevelam|Colesevelam tablets with pioglitazone therapy
10946289|NCT00789750|FG001|Participant Flow|Placebo|Placebo tablets with pioglitazone therapy
10946290|NCT00789750|OG000|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
10946291|NCT00789750|OG001|Outcome|Placebo|Placebo tablets with pioglitazone therapy
10946292|NCT00789750|EG000|Reported Event|Colesevelam|Colesevelam tablets with pioglitazone therapy
10946293|NCT00789750|EG001|Reported Event|Placebo|Placebo tablets with pioglitazone therapy
10946294|NCT00789776|BG000|Baseline|Dose 1 (2.5 x 10^6/kg NK Cells)|"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.~DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.~POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.~NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10^6/kg NK cells on day 7.~Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation~Laboratory Biomarker Analysis: Correlative studies"
10946295|NCT00789776|BG001|Baseline|Dose 2 (5.0 x 10^6/kg NK Cells)|"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.~DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.~POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.~NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10^6/kg NK cells on day 7.~Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation~Laboratory Biomarker Analysis: Correlative studies"
10946296|NCT00789776|BG002|Baseline|Total|Total of all reporting groups
10946297|NCT00789776|FG000|Participant Flow|Dose 1 (2.5 x 10^6/kg NK Cells)|"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.~DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.~POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.~NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10^6/kg NK cells on day 7.~Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation~Laboratory Biomarker Analysis: Correlative studies"
10946298|NCT00789776|FG001|Participant Flow|Dose 2 (5.0 x 10^6/kg NK Cells)|"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.~DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.~POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.~NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10^6/kg NK cells on day 7.~Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation~Laboratory Biomarker Analysis: Correlative studies"
10946299|NCT00789776|OG000|Outcome|Dose 1 (2.5 x 10^6/kg NK Cells)|"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.~DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.~POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.~NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10^6/kg NK cells on day 7.~Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation~Laboratory Biomarker Analysis: Correlative studies"
10946300|NCT00789776|OG001|Outcome|Dose 2 (5.0 x 10^6/kg NK Cells)|"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.~DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.~POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.~NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10^6/kg NK cells on day 7.~Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation~Laboratory Biomarker Analysis: Correlative studies"
10963624|NCT00873041|OG001|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10946301|NCT00789776|EG000|Reported Event|Dose 1 (2.5 x 10^6/kg NK Cells)|"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.~DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.~POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.~NK CELL INFUSION: Patients undergo donor lymphocyte infusion of NK cells on day 7.~Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Natural Killer Cell"
10946302|NCT00789776|EG001|Reported Event|Dose 2 (5.0 x 10^6/kg NK Cells)|"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.~DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.~POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.~NK CELL INFUSION: Patients undergo donor lymphocyte infusion of NK cells on day 7.~Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Natural Killer Cell"
10946303|NCT00789802|BG000|Baseline|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
10946304|NCT00789802|BG001|Baseline|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
10946305|NCT00789802|BG002|Baseline|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
10946306|NCT00789802|BG003|Baseline|Total|Total of all reporting groups
10946307|NCT00789802|FG000|Participant Flow|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
10946308|NCT00789802|FG001|Participant Flow|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
10946309|NCT00789802|FG002|Participant Flow|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
10946310|NCT00789802|OG000|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
10946311|NCT00789802|OG001|Outcome|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
10946312|NCT00789802|OG002|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
10946313|NCT00789802|OG000|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol: transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
11192181|NCT02137538|FG001|Participant Flow|Anastrozole|Participants receive anastrozole 1 mg daily
10946314|NCT00789802|OG001|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen: naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
10946315|NCT00789802|OG002|Outcome|Oral Placebo|oral placebo: oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
10946316|NCT00789802|EG000|Reported Event|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
10946317|NCT00789802|EG001|Reported Event|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
10946318|NCT00789802|EG002|Reported Event|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
10946319|NCT00789815|BG000|Baseline|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
10946320|NCT00789815|BG001|Baseline|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
10946321|NCT00789815|BG002|Baseline|Total|Total of all reporting groups
10946322|NCT00789815|FG000|Participant Flow|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
10946323|NCT00789815|FG001|Participant Flow|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
11192182|NCT02137538|OG000|Outcome|Letrozole|Participants receive letrozole 2.5 mg daily
11192183|NCT02137538|OG001|Outcome|Anastrozole|Participants receive anastrozole 1 mg daily
11192184|NCT02137538|EG000|Reported Event|Letrozole|Participants receive letrozole 2.5 mg daily
11192185|NCT02137538|EG001|Reported Event|Anastrozole|Participants receive anastrozole 1 mg daily
10946324|NCT00789815|OG000|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
10946325|NCT00789815|OG001|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
10946326|NCT00789815|EG000|Reported Event|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
10946327|NCT00789815|EG001|Reported Event|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
10946328|NCT00789828|BG000|Baseline|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
10946329|NCT00789828|BG001|Baseline|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
10946330|NCT00789828|BG002|Baseline|Total|Total of all reporting groups
10946331|NCT00789828|FG000|Participant Flow|Everolimus|Participants received oral dose of everolimus 4.5 milligram/square meter (mg/m^2) daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 nanogram/millilitre (ng/mL). Dose adjustments were permitted based on safety and whole blood trough concentrations.
10946332|NCT00789828|FG001|Participant Flow|Placebo|Participants received oral dose of placebo matching to everolimus daily.
10946333|NCT00789828|OG000|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
10946334|NCT00789828|OG001|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
10946335|NCT00789828|OG002|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
10946336|NCT00789828|OG001|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
10946337|NCT00789828|EG000|Reported Event|Everolimus Treated (Core and Extension Period)|Participants who received everolimus treatment in core period and continued to receive evrolimus treatment in extension period.
10946338|NCT00789828|EG001|Reported Event|Placebo (Core) Then Everolimus Treated (Extension Period)|Participants who received placebo in core period and then received evrolimus treatment in extension period.
10946339|NCT00789828|EG002|Reported Event|Placebo Treated (Core Period)|Participants who received placebo in core period.
10946340|NCT00789854|BG000|Baseline|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
10946341|NCT00789854|BG001|Baseline|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
10946342|NCT00789854|BG002|Baseline|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
10946343|NCT00789854|BG003|Baseline|Total|Total of all reporting groups
10946344|NCT00789854|FG000|Participant Flow|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
10946345|NCT00789854|FG001|Participant Flow|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
10946346|NCT00789854|FG002|Participant Flow|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
10946347|NCT00789854|OG000|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
10946348|NCT00789854|OG001|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
10946349|NCT00789854|OG002|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
10946350|NCT00789854|EG000|Reported Event|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
10946351|NCT00789854|EG001|Reported Event|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
10946352|NCT00789854|EG002|Reported Event|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
10946353|NCT00789867|BG000|Baseline|20ml pGM169/GL67A|Received a nebulized dose 20ml via an breath-actuated nebulizer
10946354|NCT00789867|BG001|Baseline|10ml pGM169/GL67A|Received a nebulized dose 10ml via an breath-actuated nebulizer
10946355|NCT00789867|BG002|Baseline|5ml pGM169/GL67A|Received a nebulized dose 5ml via an breath-actuated nebulizer
10946356|NCT00789867|BG003|Baseline|Total|Total of all reporting groups
10946357|NCT00789867|FG000|Participant Flow|20 ml pGM169/GL67A|Received a nebulized dose 20ml via an breath-actuated nebulizer
10946358|NCT00789867|FG001|Participant Flow|10ml pGM169/GL67A|Received a nebulized dose 10ml via an breath-actuated nebulizer
10946359|NCT00789867|FG002|Participant Flow|5ml pGM169/GL67A|Received a nebulized dose 5ml via an breath-actuated nebulizer
10946360|NCT00789867|OG000|Outcome|20ml pGM169/GL67A|Received a nebulized dose 20ml via an breath-actuated nebulizer
10946361|NCT00789867|OG001|Outcome|10ml pGM169/GL67A|Received a nebulized dose 10ml via an breath-actuated nebulizer
10946362|NCT00789867|OG002|Outcome|5ml pGM169/GL67A|Received a nebulized dose 5ml via an breath-actuated nebulizer
10946363|NCT00789867|OG000|Outcome|20ml pGM169/GL67A|Received a nebulized dose 20ml via an breath-actuated nebulizer nebulizer
10946364|NCT00789867|EG000|Reported Event|20ml pGM169/GL67A|Received a nebulized dose 20ml via an breath-actuated nebulizer
10946365|NCT00789867|EG001|Reported Event|10ml pGM169/GL67A|Received a nebulized dose 10ml via an breath-actuated nebulizer
10946366|NCT00789867|EG002|Reported Event|5ml pGM169/GL67A|Received a nebulized dose 5ml via an breath-actuated nebulizer
10946367|NCT00789880|BG000|Baseline|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
10946368|NCT00789880|BG001|Baseline|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10946369|NCT00789880|BG002|Baseline|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10946370|NCT00789880|BG003|Baseline|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
10946371|NCT00789880|BG004|Baseline|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
10946372|NCT00789880|BG005|Baseline|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
10946373|NCT00789880|BG006|Baseline|Total|Total of all reporting groups
10946374|NCT00789880|FG000|Participant Flow|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
10946375|NCT00789880|FG001|Participant Flow|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10946376|NCT00789880|FG002|Participant Flow|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10946377|NCT00789880|FG003|Participant Flow|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
10946378|NCT00789880|FG004|Participant Flow|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
10946379|NCT00789880|FG005|Participant Flow|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
10946380|NCT00789880|OG000|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10946381|NCT00789880|OG001|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
10946382|NCT00789880|OG000|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
10946383|NCT00789880|OG001|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
10946384|NCT00789880|OG000|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10946385|NCT00789880|OG001|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
10946386|NCT00789880|EG000|Reported Event|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
10946387|NCT00789880|EG001|Reported Event|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10946388|NCT00789880|EG002|Reported Event|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
10946389|NCT00789880|EG003|Reported Event|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
10946390|NCT00789880|EG004|Reported Event|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
10946391|NCT00789880|EG005|Reported Event|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
11192186|NCT02137603|BG000|Baseline|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
10946392|NCT00789958|BG000|Baseline|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
10946393|NCT00789958|FG000|Participant Flow|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
10946394|NCT00789958|OG000|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
10946395|NCT00789958|OG001|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
10946396|NCT00789958|OG000|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
10946397|NCT00789958|EG000|Reported Event|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
10946398|NCT00789997|BG000|Baseline|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
10946399|NCT00789997|BG001|Baseline|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
10946400|NCT00789997|BG002|Baseline|Total|Total of all reporting groups
10946401|NCT00789997|FG000|Participant Flow|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
10946402|NCT00789997|FG001|Participant Flow|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
10946403|NCT00789997|OG000|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
10946404|NCT00789997|OG001|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
10946405|NCT00789997|EG000|Reported Event|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
10946406|NCT00789997|EG001|Reported Event|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
10946407|NCT00790023|BG000|Baseline|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
10946408|NCT00790023|BG001|Baseline|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
10946409|NCT00790023|BG002|Baseline|Placebo|Placebo once daily
10946410|NCT00790023|BG003|Baseline|Total|Total of all reporting groups
10946411|NCT00790023|FG000|Participant Flow|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
10946412|NCT00790023|FG001|Participant Flow|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
10946413|NCT00790023|FG002|Participant Flow|Placebo|Placebo once daily
10946414|NCT00790023|OG000|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
10946415|NCT00790023|OG001|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
10946416|NCT00790023|OG002|Outcome|Placebo|Placebo once daily
10946417|NCT00790023|OG002|Outcome|Placebo|
10946418|NCT00790023|EG000|Reported Event|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
10946419|NCT00790023|EG001|Reported Event|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
10946420|NCT00790023|EG002|Reported Event|Placebo|Placebo once daily
10946421|NCT00790036|BG000|Baseline|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
10946422|NCT00790036|BG001|Baseline|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
10946423|NCT00790036|BG002|Baseline|Total|Total of all reporting groups
10946424|NCT00790036|FG000|Participant Flow|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
10946425|NCT00790036|FG001|Participant Flow|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
10946426|NCT00790036|OG000|Outcome|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
10946427|NCT00790036|OG001|Outcome|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
10946428|NCT00790036|EG000|Reported Event|RAD001 (Everolimus)|RAD001 10 mg (two 5 mg tablets), daily for 12 months
10946429|NCT00790036|EG001|Reported Event|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
10946430|NCT00790036|EG002|Reported Event|All Patients|All Patients in the Everolimus and Placebo groups.
10946431|NCT00790062|BG000|Baseline|Oxytocin 10 Units/500cc|
10946432|NCT00790062|BG001|Baseline|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
10946433|NCT00790062|BG002|Baseline|Oxytocin 80U/500cc|
10946434|NCT00790062|BG003|Baseline|Total|Total of all reporting groups
10946435|NCT00790062|FG000|Participant Flow|Oxytocin 10 Units/500cc|
10946436|NCT00790062|FG001|Participant Flow|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
10946437|NCT00790062|FG002|Participant Flow|Oxytocin 80U/500cc|
10946438|NCT00790062|OG000|Outcome|Oxytocin 10 Units/500cc|1 dose only for prophylaxsis given over 1 hour
10946439|NCT00790062|OG001|Outcome|Oxytocin 40 Units/500cc|"Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~1 dose only for prophylaxsis given over 1 hour"
10946440|NCT00790062|OG002|Outcome|Oxytocin 80U/500cc|1 dose only for prophylaxsis given over 1 hour
10946441|NCT00790062|OG000|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour~Oxytocin: See arms"
10946442|NCT00790062|OG001|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~Oxytocin: See arms"
10946443|NCT00790062|OG002|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour~Oxytocin: See arms"
10946444|NCT00790062|OG000|Outcome|Oxytocin 10 Units/500cc Over 1 Hour|
10946445|NCT00790062|OG001|Outcome|Oxytocin 40 Units/500cc Over 1 Hour|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
10946446|NCT00790062|OG002|Outcome|Oxytocin 80U/500cc Over 1 Hour|
10946447|NCT00790062|OG000|Outcome|Oxytocin 10 Units/500cc|
10946448|NCT00790062|OG001|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
10946449|NCT00790062|OG002|Outcome|Oxytocin 80U/500cc|
10946450|NCT00790062|EG000|Reported Event|Oxytocin 10 Units/500cc|
10946451|NCT00790062|EG001|Reported Event|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
10946452|NCT00790062|EG002|Reported Event|Oxytocin 80U/500cc|
10946453|NCT00790088|BG000|Baseline|Sensor-augmented Pump|CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time
10946454|NCT00790088|FG000|Participant Flow|Sensor-augmented Pump|CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time
10946455|NCT00790088|OG000|Outcome|Whole Population|all available data from eligible patients at baseline
10946456|NCT00790088|OG000|Outcome|Sensor-augmented Pump|CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time
10946457|NCT00790088|OG000|Outcome|SAP Users|Patients in Spain, Denmark and Hungary participated, where the questionnaires translations were validated
10946458|NCT00790088|EG000|Reported Event|Sensor-augmented Pump|CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time
10946459|NCT00790192|BG000|Baseline|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
10946460|NCT00790192|BG001|Baseline|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
10946461|NCT00790192|BG002|Baseline|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
10946462|NCT00790192|BG003|Baseline|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
10946463|NCT00790192|BG004|Baseline|Total|Total of all reporting groups
10946464|NCT00790192|FG000|Participant Flow|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
10946465|NCT00790192|FG001|Participant Flow|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
10946466|NCT00790192|FG002|Participant Flow|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
10946467|NCT00790192|FG003|Participant Flow|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
10946468|NCT00790192|OG000|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
10946469|NCT00790192|OG001|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
10946470|NCT00790192|OG002|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
10946471|NCT00790192|OG003|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
10946472|NCT00790192|EG000|Reported Event|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
10946473|NCT00790192|EG001|Reported Event|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
10946474|NCT00790192|EG002|Reported Event|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
10946475|NCT00790192|EG003|Reported Event|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
10946476|NCT00790205|BG000|Baseline|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
10946477|NCT00790205|BG001|Baseline|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
10946478|NCT00790205|BG002|Baseline|Total|Total of all reporting groups
10946479|NCT00790205|FG000|Participant Flow|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
10946480|NCT00790205|FG001|Participant Flow|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
10946481|NCT00790205|OG000|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
10946482|NCT00790205|OG001|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
10946483|NCT00790205|EG000|Reported Event|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
10946484|NCT00790205|EG001|Reported Event|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
10946485|NCT00790270|BG000|Baseline|Cyclobenzaprine|
10946486|NCT00790270|BG001|Baseline|Ibuprofen|
10946487|NCT00790270|BG002|Baseline|Ibuprophen Plus Cyclobenzaprine|
10946488|NCT00790270|BG003|Baseline|Total|Total of all reporting groups
11192187|NCT02137603|BG001|Baseline|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
10946489|NCT00790270|FG000|Participant Flow|Cyclobenzaprine|
10946490|NCT00790270|FG001|Participant Flow|Ibuprofen|
10946491|NCT00790270|FG002|Participant Flow|Ibuprophen Plus Cyclobenzaprine|
10946492|NCT00790270|OG000|Outcome|Cyclobenzaprine|
10946493|NCT00790270|OG001|Outcome|Ibuprofen|
10946494|NCT00790270|OG002|Outcome|Ibuprophen Plus Cyclobenzaprine|
10946495|NCT00790270|EG000|Reported Event|Cyclobenzaprine|
10946496|NCT00790270|EG001|Reported Event|Ibuprofen|
10946497|NCT00790270|EG002|Reported Event|Ibuprophen Plus Cyclobenzaprine|
10946498|NCT00790296|BG000|Baseline|TRH Then Saline|TRH (0.5mg) given first followed by Saline
10946499|NCT00790296|BG001|Baseline|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
10946500|NCT00790296|BG002|Baseline|Total|Total of all reporting groups
10946501|NCT00790296|FG000|Participant Flow|TRH Then Saline|TRH (0.5mg) given first followed by Saline
10946502|NCT00790296|FG001|Participant Flow|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
10946503|NCT00790296|OG000|Outcome|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
10946504|NCT00790296|OG001|Outcome|Saline|Saline given Intravenously
10946505|NCT00790296|EG000|Reported Event|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
10946506|NCT00790296|EG001|Reported Event|Saline|Saline given intravenously
10946507|NCT00790335|BG000|Baseline|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
10946508|NCT00790335|BG001|Baseline|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
10946509|NCT00790335|BG002|Baseline|Total|Total of all reporting groups
10946510|NCT00790335|FG000|Participant Flow|A-Intervention|"Pharmacomechanical catheter-directed thrombolysis (PCDT) with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
10946511|NCT00790335|FG001|Participant Flow|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio [INR} 2.0 - 3.0). Elastic compression stockings will be prescribed
10946512|NCT00790335|OG000|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
10946513|NCT00790335|OG001|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
10963625|NCT00873041|OG000|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
11192188|NCT02137603|BG002|Baseline|Total|Total of all reporting groups
11192189|NCT02137603|FG000|Participant Flow|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
10946514|NCT00790335|EG000|Reported Event|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
10946515|NCT00790335|EG001|Reported Event|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
10946516|NCT00790400|BG000|Baseline|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
10946517|NCT00790400|BG001|Baseline|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
10946518|NCT00790400|BG002|Baseline|Total|Total of all reporting groups
10946519|NCT00790400|FG000|Participant Flow|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
10946520|NCT00790400|FG001|Participant Flow|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
10946521|NCT00790400|OG000|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
10946522|NCT00790400|OG001|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
10946523|NCT00790400|OG002|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
10946524|NCT00790400|OG001|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
10946525|NCT00790400|EG000|Reported Event|Everolimus Randomized (Core & Ext)|Patients who were randomized and treated with Everolimus during the Core and Extension phase
10946526|NCT00790400|EG001|Reported Event|Placebo Randomized/Crossed Over to Everolimus|Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase
10946527|NCT00790400|EG002|Reported Event|Placebo Randomized/Never Crossed-over|Patients randomized to placebo who never crossed-over to Everolimus
10946528|NCT00790556|BG000|Baseline|All Participants|All participants
10946529|NCT00790556|FG000|Participant Flow|MK8245 Then Placebo|"During Treatment Period 1, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~During Treatment Period 2, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
10946530|NCT00790556|FG001|Participant Flow|Placebo Then MK8245|"During Treatment Period 1, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~During Treatment Period 2, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
10946531|NCT00790556|OG000|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
10946532|NCT00790556|OG001|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
11192190|NCT02137603|FG001|Participant Flow|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
10946533|NCT00790556|EG000|Reported Event|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
10946534|NCT00790556|EG001|Reported Event|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
10946535|NCT00790569|BG000|Baseline|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
10946536|NCT00790569|BG001|Baseline|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
10946537|NCT00790569|BG002|Baseline|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
10946538|NCT00790569|BG003|Baseline|Total|Total of all reporting groups
10946539|NCT00790569|FG000|Participant Flow|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
10946540|NCT00790569|FG001|Participant Flow|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
10946541|NCT00790569|FG002|Participant Flow|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
10946542|NCT00790569|OG000|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
11192191|NCT02137603|OG000|Outcome|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
10946543|NCT00790569|OG001|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
10946544|NCT00790569|OG002|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
10946545|NCT00790569|EG000|Reported Event|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
10946546|NCT00790569|EG001|Reported Event|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
10946547|NCT00790569|EG002|Reported Event|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
10946548|NCT00790582|BG000|Baseline|Lithium Carbonate|
10946549|NCT00790582|BG001|Baseline|Historical Controls|
10946550|NCT00790582|BG002|Baseline|Total|Total of all reporting groups
10946551|NCT00790582|FG000|Participant Flow|Treatment|109 subjects were assigned to treatment with lithium carbonate
10946552|NCT00790582|FG001|Participant Flow|Control|249 placebo subjects from previous clinical trials
11177675|NCT02043132|EG000|Reported Event|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
11177676|NCT02043132|EG001|Reported Event|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
11177677|NCT02043145|BG000|Baseline|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177678|NCT02043145|BG001|Baseline|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177679|NCT02043145|BG002|Baseline|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177680|NCT02043145|BG003|Baseline|Total|Total of all reporting groups
11177681|NCT02043145|FG000|Participant Flow|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177682|NCT02043145|FG001|Participant Flow|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
10946553|NCT00790582|OG000|Outcome|Lithium Carbonate|
10946554|NCT00790582|OG001|Outcome|Historical Controls|
10946555|NCT00790582|OG000|Outcome|Lithium Carbonate|Treatment arm
10946556|NCT00790582|OG001|Outcome|Control|Placebo arm
10946557|NCT00790582|EG000|Reported Event|Lithium Carbonate|Treated Patients
10946558|NCT00790582|EG001|Reported Event|Historical Controls|Placebo Patients
10946559|NCT00790647|BG000|Baseline|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D -2, D -1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
10946560|NCT00790647|FG000|Participant Flow|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D -2, D -1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
10946561|NCT00790647|OG000|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D -2, D -1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
10946562|NCT00790647|OG000|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D -2, D -1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
10946563|NCT00790647|OG000|Outcome|Stem Cell Transplantation With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D -2, D -1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
10946564|NCT00790647|EG000|Reported Event|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D -2, D -1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
10946565|NCT00790673|BG000|Baseline|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
10946566|NCT00790673|BG001|Baseline|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
10946567|NCT00790673|BG002|Baseline|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
10946568|NCT00790673|BG003|Baseline|Placebo|Placebo: Matching placebo capsules
10946569|NCT00790673|BG004|Baseline|Total|Total of all reporting groups
10946570|NCT00790673|FG000|Participant Flow|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
10946571|NCT00790673|FG001|Participant Flow|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
10946572|NCT00790673|FG002|Participant Flow|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
10946573|NCT00790673|FG003|Participant Flow|Placebo|Placebo: Matching placebo capsules
11177683|NCT02043145|FG002|Participant Flow|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177684|NCT02043145|OG000|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177685|NCT02043145|OG001|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177686|NCT02043145|OG002|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177687|NCT02043145|OG000|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177688|NCT02043145|OG000|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177689|NCT02043145|EG000|Reported Event|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177690|NCT02043145|EG001|Reported Event|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177691|NCT02043145|EG002|Reported Event|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
11177692|NCT02043197|BG000|Baseline|Outpatients With Neurological Disorders and Depression.|Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
11177693|NCT02043197|FG000|Participant Flow|Outpatients With Neurological Disorders and Depression.|Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
10946574|NCT00790673|OG000|Outcome|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
10946575|NCT00790673|OG001|Outcome|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
10946576|NCT00790673|OG002|Outcome|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
10946577|NCT00790673|OG003|Outcome|Placebo|Placebo: Matching placebo capsules
10946578|NCT00790673|EG000|Reported Event|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
10946579|NCT00790673|EG001|Reported Event|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
10946580|NCT00790673|EG002|Reported Event|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
10946581|NCT00790673|EG003|Reported Event|Placebo|Placebo: Matching placebo capsules
10946582|NCT00790699|BG000|Baseline|I-PORT|I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
10946583|NCT00790699|BG001|Baseline|Standard Injections|standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
10946584|NCT00790699|BG002|Baseline|Total|Total of all reporting groups
10946585|NCT00790699|FG000|Participant Flow|I-PORT|I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
10946586|NCT00790699|FG001|Participant Flow|Standard Injections|standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections. The standard injections are usually 3-4 times daily.
10946587|NCT00790699|OG000|Outcome|I-PORT|I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
10946588|NCT00790699|OG001|Outcome|Standard Injections|standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
10946589|NCT00790699|OG000|Outcome|Visit 1|Patient reports at visit 1
10946590|NCT00790699|OG001|Outcome|Visit 6|Patient reports at last visit (3 months)
10946591|NCT00790699|EG000|Reported Event|Iport|Treatment group/ Iport Users
10946592|NCT00790699|EG001|Reported Event|Standard Injections|Control group/ Standard Injections
10946593|NCT00790738|BG000|Baseline|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
10946594|NCT00790738|BG001|Baseline|Placebo|"placebo~placebo: placebo"
10946595|NCT00790738|BG002|Baseline|Total|Total of all reporting groups
10946596|NCT00790738|FG000|Participant Flow|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
10946597|NCT00790738|FG001|Participant Flow|Placebo|"placebo~placebo: placebo"
10946598|NCT00790738|OG000|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
10946599|NCT00790738|OG001|Outcome|Placebo|"placebo~placebo: placebo"
11177694|NCT02043197|OG000|Outcome|Outpatients With Neurological Disorders and Depression.|Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
11177695|NCT02043197|EG000|Reported Event|Outpatients With Neurological Disorders and Depression.|Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
11177696|NCT02043301|BG000|Baseline|Bococizumab 150 mg Abdomen|Participants received a single dose of bococizumab 150 mg SC to the abdomen.
11177697|NCT02043301|BG001|Baseline|Bococizumab 150 mg Thigh|Participants received a single dose of bococizumab 150 mg SC to the thigh.
11177698|NCT02043301|BG002|Baseline|Bococizumab 150 mg Upper Arm|Participants received a single dose of bococizumab 150 mg SC to the upper arm.
11177699|NCT02043301|BG003|Baseline|Total|Total of all reporting groups
11177700|NCT02043301|FG000|Participant Flow|Bococizumab 150 mg Abdomen|Participants received a single dose of bococizumab 150 mg SC to the abdomen.
10946600|NCT00790738|EG000|Reported Event|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
10946601|NCT00790738|EG001|Reported Event|Placebo|"placebo~placebo: placebo"
11177701|NCT02043301|FG001|Participant Flow|Bococizumab 150 mg Thigh|Participants received a single dose of bococizumab 150 mg SC to the thigh.
11177702|NCT02043301|FG002|Participant Flow|Bococizumab 150 mg Upper Arm|Participants received a single dose of bococizumab 150 mg SC to the upper arm.
11177703|NCT02043301|OG000|Outcome|Bococizumab 150 mg Abdomen|Participants received a single dose of bococizumab 150 mg SC to the abdomen.
10946602|NCT00790751|BG000|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10946603|NCT00790751|BG001|Baseline|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
10946604|NCT00790751|BG002|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10946605|NCT00790751|BG003|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10946606|NCT00790751|BG004|Baseline|Total|Total of all reporting groups
10946607|NCT00790751|FG000|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10946608|NCT00790751|FG001|Participant Flow|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
10946609|NCT00790751|FG002|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10946610|NCT00790751|FG003|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10946611|NCT00790751|OG000|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10946612|NCT00790751|OG001|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
10946613|NCT00790751|OG002|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10946614|NCT00790751|OG003|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10946615|NCT00790751|EG000|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10946616|NCT00790751|EG001|Reported Event|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
11177704|NCT02043301|OG001|Outcome|Bococizumab 150 mg Thigh|Participants received a single dose of bococizumab 150 mg SC to the thigh.
11177705|NCT02043301|OG002|Outcome|Bococizumab 150 mg Upper Arm|Participants received a single dose of bococizumab 150 mg SC to the upper arm.
11177706|NCT02043301|EG000|Reported Event|Bococizumab 150 mg Abdomen|Participants received a single dose of bococizumab 150 mg SC to the abdomen.
11177707|NCT02043301|EG001|Reported Event|Bococizumab 150 mg Thigh|Participants received a single dose of bococizumab 150 mg SC to the thigh.
11177708|NCT02043301|EG002|Reported Event|Bococizumab 150 mg Upper Arm|Participants received a single dose of bococizumab 150 mg SC to the upper arm.
11177709|NCT02043366|BG000|Baseline|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
11177710|NCT02043366|BG001|Baseline|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
11177711|NCT02043366|BG002|Baseline|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
11177712|NCT02043366|BG003|Baseline|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
11177713|NCT02043366|BG004|Baseline|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
11177714|NCT02043366|BG005|Baseline|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
11177715|NCT02043366|BG006|Baseline|Total|Total of all reporting groups
11177716|NCT02043366|FG000|Participant Flow|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
11177717|NCT02043366|FG001|Participant Flow|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
11192192|NCT02137603|OG001|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
10946617|NCT00790751|EG002|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10946618|NCT00790751|EG003|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10963626|NCT00873041|EG000|Reported Event|Deferasirox 5 mg/kg/Day|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10963627|NCT00873041|EG001|Reported Event|Deferasirox 10 mg/kg/Day|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10963628|NCT00873041|EG002|Reported Event|Placebo/Deferasirox Any Dose|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
10963629|NCT00873093|BG000|Baseline|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963630|NCT00873093|BG001|Baseline|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963631|NCT00873093|BG002|Baseline|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963632|NCT00873093|BG003|Baseline|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963633|NCT00873093|BG004|Baseline|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963634|NCT00873093|BG005|Baseline|Total|Total of all reporting groups
10963635|NCT00873093|FG000|Participant Flow|Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963636|NCT00873093|FG001|Participant Flow|Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963637|NCT00873093|FG002|Participant Flow|Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963638|NCT00873093|FG003|Participant Flow|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963639|NCT00873093|FG004|Participant Flow|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963640|NCT00873093|OG000|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963641|NCT00873093|OG001|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10946619|NCT00790790|BG000|Baseline|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
10946620|NCT00790790|BG001|Baseline|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
10946621|NCT00790790|BG002|Baseline|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
10946622|NCT00790790|BG003|Baseline|Total|Total of all reporting groups
10946623|NCT00790790|FG000|Participant Flow|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
10946624|NCT00790790|FG001|Participant Flow|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
10946625|NCT00790790|FG002|Participant Flow|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
10946626|NCT00790790|OG000|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
10946627|NCT00790790|OG001|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
10946628|NCT00790790|OG002|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
10946629|NCT00790790|OG000|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
10946630|NCT00790790|OG001|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
10946631|NCT00790790|EG000|Reported Event|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
10946632|NCT00790790|EG001|Reported Event|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) twice daily (BID) oral (po) were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
10946633|NCT00790790|EG002|Reported Event|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
10946634|NCT00790790|EG003|Reported Event|Placebo Washout|1 week washout period from taking placebo
10946635|NCT00790790|EG004|Reported Event|LY545694 49 mg Washout|1 week washout period from taking 49 mg LY545694
10946636|NCT00790790|EG005|Reported Event|LY545694 105 mg Washout|1 week washout period from taking 105 mg LY545694
10946637|NCT00790842|BG000|Baseline|Group A=30-60 CrCl (mL/Min)|"Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.~Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II."
10946638|NCT00790842|BG001|Baseline|Group B=CrCL<30 mL/Min Not on Dialysis|"Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.~Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II."
10946639|NCT00790842|BG002|Baseline|Group C=CrCL<30 mL/Min and on Dialysis|"Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.~Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.~Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis."
10946640|NCT00790842|BG003|Baseline|Total|Total of all reporting groups
10946641|NCT00790842|FG000|Participant Flow|Group A Lenalidomide 10 mg/Day|Creatinine clearance (CrCl) of 30 - 60 mL/min. Lenalidomide 10 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
10946642|NCT00790842|FG001|Participant Flow|Group A Lenalidomide 15 mg/Day|Creatinine clearance of 30 - 60 mL/min. Treated with lenalidomide 15 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
10946643|NCT00790842|FG002|Participant Flow|Group A Lenalidomide 25 mg/Day|Creatinine clearance of 30 - 60 mL/min. Treated with lenalidomide 25 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
10946644|NCT00790842|FG003|Participant Flow|Group B Lenalidomide 15 mg/2 Days|Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide 15 mg/every other day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
10946645|NCT00790842|FG004|Participant Flow|Group B Lenalidomide 25 mg/2 Days|Creatinine clearance of <30 mL/min, not on dialysis. Treated with lenalidomide 25 mg every other day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
10946646|NCT00790842|FG005|Participant Flow|Group B Lenalidomide 15 mg/Day|Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide at 15 mg/day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
10946647|NCT00790842|FG006|Participant Flow|Group B Lenalidomide 25 mg/Day|Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide at 25 mg/day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
10946648|NCT00790842|FG007|Participant Flow|Group C Lenalidomide 15 mg 3x/Week|"Creatinine clearance of 30 - 60 mL/min and on dialysis. Treated with lenalidomide 15 mg 3 days/week for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.~Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis."
10946649|NCT00790842|FG008|Participant Flow|Group C Lenalidomide 10 mg/Day|Creatinine Clearance < 30 mL/min and on dialysis, treated with lenalidomide 15 mg 3 times per week, dexamethasone and anticoagulant
10946650|NCT00790842|FG009|Participant Flow|Group C Lenalidomide 15 mg/Day|Creatinine Clearance < 30 mL/min and on dialysis, treated with lenalidomide 10 mg/day, dexamethasone, and anticoagulants
10946651|NCT00790842|FG010|Participant Flow|Group C, Lenalidomide 25 mg/Day|Creatinine clearance < 30 mL/min and on dialysis, treated with lenalidomide at 25 mg/day, dexamethasone, and anticoagulants
10946652|NCT00790842|OG000|Outcome|Group A Lenalidomide 10 mg/Day|CrCl 30-60 mL/min, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days along with anticoagulants.
10946653|NCT00790842|OG001|Outcome|Group A Lenalidomide 15 mg/Day|CrCl 30-60 mL/min, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946654|NCT00790842|OG002|Outcome|Group A Lenalidomide 25 mg/Day|CrCL 30-60 mL/min, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946655|NCT00790842|OG003|Outcome|Group B Lenalidomide 15 mg/2 Days|CrCl<30 mL/min, not on dialysis, Lenalidomide at 15 mg/every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946656|NCT00790842|OG004|Outcome|Group B Lenalidomide 25 mg/2 Days|CrCl < 30 mL/min, not on dialysis, Lenalidomide at 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946657|NCT00790842|OG005|Outcome|Group B Lenalidomide 15 mg/Day|CrCl < 30 mL/min, not on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946658|NCT00790842|OG006|Outcome|Group B Lenalidomide 25 mg/Day|CrCl < 30 mL/min, not on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946659|NCT00790842|OG007|Outcome|Group C Lenalidomide 15 mg 3x/Week|CrCl < 30 mL/min, on dialysis, Lenalidomide at 15 mg 3 times per week for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946660|NCT00790842|OG008|Outcome|Group C Lenalidomide 10 mg/Day|CrCl < 30 mL/min, on dialysis, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946661|NCT00790842|OG009|Outcome|Group C Lenalidomide 15 mg/Day|CrCl < 30 mL/min, on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946662|NCT00790842|OG010|Outcome|Group C Lenalidomide 25 mg/Day|CrCl < 30 ml/min, on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
10946663|NCT00790842|OG000|Outcome|Group A CrCl 30-60 mL/Min|Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946664|NCT00790842|OG001|Outcome|Group B CrCL<30 mL/Min, Not on Dialysis|Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946665|NCT00790842|OG002|Outcome|Group C CrCL<30 mL/Min and on Dialysis|Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946666|NCT00790842|OG000|Outcome|Group A=30-60 CrCl (mL/Min)|"Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.~Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II."
10946667|NCT00790842|OG001|Outcome|Group B=CrCL<30 mL/Min Not on Dialysis|"Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.~Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II."
10946668|NCT00790842|OG002|Outcome|Group C=CrCL<30 mL/Min and on Dialysis|"Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.~Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.~Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis."
10946669|NCT00790842|OG000|Outcome|Group A=30-60 CrCl (mL/Min)|Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946670|NCT00790842|OG001|Outcome|Group B=CrCL<30 mL/Min Not on Dialysis|Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946671|NCT00790842|OG002|Outcome|Group C=CrCL<30 mL/Min and on Dialysis|Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
10946672|NCT00790842|OG000|Outcome|Group A Lenalidomide 10 mg/Day|CrCl 30-60 mL/min, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946673|NCT00790842|OG001|Outcome|Group A Lenalidomide 15 mg/Day|CrCl 30-60 mL/min, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946674|NCT00790842|OG002|Outcome|Group A Lenalidomide 25 mg/Day|CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946675|NCT00790842|OG003|Outcome|Group A Expansion Cohort|CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
10946676|NCT00790842|OG004|Outcome|Group B Lenalidomide 15 mg/2 Days|CrCl < 30 mL/min, not on dialysis. Lenalidomide days 15 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946677|NCT00790842|OG005|Outcome|Group B Lenalidomide 25 mg/2 Days|CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946678|NCT00790842|OG006|Outcome|Group B Lenalidomide 15 mg/Day|CrCl < 30 mL/min, not on dialysis. Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946679|NCT00790842|OG007|Outcome|Group B Lenalidomide 25 mg/Day|CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946680|NCT00790842|OG008|Outcome|Group B Expansion Cohort|CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
10946681|NCT00790842|OG009|Outcome|Group C Lenalidomide 15 mg 3x/Week|CrCl < 30 mL/min, on dialysis, Lenalidomide 15 mg 3 times a week from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946682|NCT00790842|OG010|Outcome|Group C Lenalidomide 10 mg/Day|CrCl < 30 mL/min, on dialysis, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946683|NCT00790842|OG011|Outcome|Group C Lenalidomide 15 mg/Day|CrCl < 30 mL/min, on dialysis, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946684|NCT00790842|OG012|Outcome|Group C Lenalidomide 25 mg/Day|CrCl < 30 mL/min, on dialysis, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946685|NCT00790842|EG000|Reported Event|Group A Lenalidomide 10 mg/Day|CrCl 30-60 mL/min. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946686|NCT00790842|EG001|Reported Event|Group A Lenalidomide 15 mg/Day|CrCl 30-60 mL/min. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946687|NCT00790842|EG002|Reported Event|Group A Lenalidomide 25 mg/Day|CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
11177718|NCT02043366|FG002|Participant Flow|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
11177719|NCT02043366|FG003|Participant Flow|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
11177720|NCT02043366|FG004|Participant Flow|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/kg butorphanol and a dose of 0.5mg/kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
11177721|NCT02043366|FG005|Participant Flow|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
10946688|NCT00790842|EG003|Reported Event|Group A Expansion Cohort|CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
10946689|NCT00790842|EG004|Reported Event|Group B Lenalidomide 15 mg/2 Days|CrCl <30 mL/min, not on dialysis. Lenalidomide 15 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946690|NCT00790842|EG005|Reported Event|Group B Lenalidomide 25 mg/2 Days|CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946691|NCT00790842|EG006|Reported Event|Group B Lenalidomide 15 mg/Day|CrCl <30 mL/min, not on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946692|NCT00790842|EG007|Reported Event|Group B Lenalidomide 25 mg/Day|CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946693|NCT00790842|EG008|Reported Event|Group B Expansion Cohort|CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
10946694|NCT00790842|EG009|Reported Event|Group C Lenalidomide 15 mg 3x/wk|CrCl < 30 mL/min, on dialysis. Lenalidomide 15 mg three times weekly for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946695|NCT00790842|EG010|Reported Event|Group C Lenalidomide 10 mg/Day|CrCl < 30 mL/min, on dialysis. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946696|NCT00790842|EG011|Reported Event|Group C Lenalidomide 15 mg/Day|CrCl < 30 mL/min, on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946697|NCT00790842|EG012|Reported Event|Group C Lenalidomide 25 mg/Day|CrCl < 30 mL/min, on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
10946698|NCT00790855|BG000|Baseline|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
10946699|NCT00790855|FG000|Participant Flow|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
10946700|NCT00790855|OG000|Outcome|Bendamustine|Starting dose 50 mg/m^2 intravenously, over 2 hours twice on Days 1-4 of every 4 week study cycle, with dose escalation of 25 mg/m^2 for 3 levels.
10946701|NCT00790855|OG000|Outcome|Bendamustine (75 mg/m^2)|75 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
11177722|NCT02043366|OG000|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
10946702|NCT00790855|EG000|Reported Event|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
10946703|NCT00790868|BG000|Baseline|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
10946704|NCT00790868|BG001|Baseline|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
10946705|NCT00790868|BG002|Baseline|Total|Total of all reporting groups
10946706|NCT00790868|FG000|Participant Flow|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
10946707|NCT00790868|FG001|Participant Flow|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
10946708|NCT00790868|OG000|Outcome|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
11177723|NCT02043366|OG001|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
11177724|NCT02043366|OG002|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
10946709|NCT00790868|OG001|Outcome|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
10946710|NCT00790868|OG000|Outcome|D-cycloserine|"DCS-augmented CBT~d-cycloserine: 50mg"
10946711|NCT00790868|OG001|Outcome|Placebo|"placebo-augmented CBT~placebo: 50mg"
10946712|NCT00790868|EG000|Reported Event|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
10946713|NCT00790868|EG001|Reported Event|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
10946714|NCT00790907|BG000|Baseline|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
10946715|NCT00790907|BG001|Baseline|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
10946716|NCT00790907|BG002|Baseline|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
10946717|NCT00790907|BG003|Baseline|Total|Total of all reporting groups
10946718|NCT00790907|FG000|Participant Flow|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
10963642|NCT00873093|OG002|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10946719|NCT00790907|FG001|Participant Flow|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
10946720|NCT00790907|FG002|Participant Flow|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
10963643|NCT00873093|OG003|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
11177725|NCT02043366|OG003|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
11177726|NCT02043366|OG004|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
11177727|NCT02043366|OG005|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
11177728|NCT02043366|OG003|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
11177729|NCT02043366|OG004|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
11177730|NCT02043366|EG000|Reported Event|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
11177731|NCT02043366|EG001|Reported Event|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
11177732|NCT02043366|EG002|Reported Event|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
11177733|NCT02043366|EG003|Reported Event|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentani
11177734|NCT02043366|EG004|Reported Event|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentani
11177735|NCT02043366|EG005|Reported Event|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
11177736|NCT02043379|BG000|Baseline|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
11177737|NCT02043379|BG001|Baseline|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
11177738|NCT02043379|BG002|Baseline|Total|Total of all reporting groups
11177739|NCT02043379|FG000|Participant Flow|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
11177740|NCT02043379|FG001|Participant Flow|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
11177741|NCT02043379|OG000|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
10946721|NCT00790907|OG000|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
10946722|NCT00790907|OG001|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
10946723|NCT00790907|EG000|Reported Event|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
10946724|NCT00790907|EG001|Reported Event|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
10946725|NCT00790907|EG002|Reported Event|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
10946726|NCT00791037|BG000|Baseline|Treatment (Vaccine Therapy+ex Vivo T Cell Expansion)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
10946727|NCT00791037|FG000|Participant Flow|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
10946728|NCT00791037|OG000|Outcome|Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
10946729|NCT00791037|OG000|Outcome|Treatment (Vaccine Therapy)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
10963644|NCT00873093|OG004|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963645|NCT00873093|OG000|Outcome|Overall|All enrolled eligible patients.
11240731|NCT02481375|EG002|Reported Event|Iron Only|"This formulation only has 60 mg elemental iron.~Women will receive iron for 12 weeks.~Iron: 12-wk supplementation of iron"
10946730|NCT00791037|OG000|Outcome|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
10946731|NCT00791037|EG000|Reported Event|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
10946732|NCT00791089|BG000|Baseline|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
10946733|NCT00791089|BG001|Baseline|Placebo, Ablation, Sinus Rhythm|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
10946734|NCT00791089|BG002|Baseline|Total|Total of all reporting groups
10946735|NCT00791089|FG000|Participant Flow|Fish Oil, Ablation, Sinus Rhythm|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
10946736|NCT00791089|FG001|Participant Flow|Placebo, Ablation, Sinus Rhythm|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
10946737|NCT00791089|OG000|Outcome|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
10946738|NCT00791089|OG001|Outcome|Placebo, Ablation|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
10946739|NCT00791089|EG000|Reported Event|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
10946740|NCT00791089|EG001|Reported Event|Placebo, Ablation|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
11177742|NCT02043379|OG001|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
10946741|NCT00791102|BG000|Baseline|All Study Participants|
10946742|NCT00791102|FG000|Participant Flow|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
10946743|NCT00791102|FG001|Participant Flow|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
10946744|NCT00791102|OG000|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
10946745|NCT00791102|OG001|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
10946746|NCT00791102|EG000|Reported Event|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
10946747|NCT00791102|EG001|Reported Event|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
10946748|NCT00791128|BG000|Baseline|EndoBarrier Liner Device|Subjects implanted with the EndoBarrier for up to 12 months.
10946749|NCT00791128|FG000|Participant Flow|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
10946750|NCT00791128|OG000|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
10946751|NCT00791128|EG000|Reported Event|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
10946752|NCT00791219|BG000|Baseline|Placebo|"Two placebo capsules taken approximately 30 minutes prior to breakfast~Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast"
11240732|NCT02481375|EG003|Reported Event|Placebo|"This formulation is a placebo.~Women will receive a placebo for 12 weeks.~Placebo: 12-wk supplementation of placebo"
10946753|NCT00791219|BG001|Baseline|Test|"100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)~SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)"
10946754|NCT00791219|BG002|Baseline|Reference|"200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).~Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma)."
10946755|NCT00791219|BG003|Baseline|Total|Total of all reporting groups
10946756|NCT00791219|FG000|Participant Flow|Placebo|"Two placebo capsules taken approximately 30 minutes prior to breakfast~Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast"
10946757|NCT00791219|FG001|Participant Flow|Test|"100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)~SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)"
10946758|NCT00791219|FG002|Participant Flow|Reference|"200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).~Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma)."
10946759|NCT00791219|OG000|Outcome|Placebo|"Two placebo capsules taken approximately 30 minutes prior to breakfast~Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast"
10946760|NCT00791219|OG001|Outcome|Test|"100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)~SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)"
10946761|NCT00791219|OG002|Outcome|Reference|"200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).~Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma)."
10946762|NCT00791219|EG000|Reported Event|Placebo|"Two placebo capsules taken approximately 30 minutes prior to breakfast~Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast"
10946763|NCT00791219|EG001|Reported Event|Test|"100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)~SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)"
10946764|NCT00791219|EG002|Reported Event|Reference|"200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).~Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma)."
11177743|NCT02043379|EG000|Reported Event|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
10946765|NCT00791258|BG000|Baseline|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
10946766|NCT00791258|FG000|Participant Flow|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
10946767|NCT00791258|OG000|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
10946768|NCT00791258|EG000|Reported Event|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
10946769|NCT00791323|BG000|Baseline|Ketorolac 0.4%|Ketorolac 0.4%
10946770|NCT00791323|BG001|Baseline|Soothe® XP|Mineral Oil Emollient
10946771|NCT00791323|BG002|Baseline|Total|Total of all reporting groups
10946772|NCT00791323|FG000|Participant Flow|Ketorolac 0.4%|Ketorolac 0.4%
10946773|NCT00791323|FG001|Participant Flow|Soothe® XP|Mineral Oil Emollient
10946774|NCT00791323|OG000|Outcome|Ketorolac 0.4%|Ketorolac 0.4%
10946775|NCT00791323|OG001|Outcome|Soothe® XP|Mineral Oil Emollient
10946776|NCT00791323|EG000|Reported Event|Ketorolac 0.4%|Ketorolac 0.4%
10946777|NCT00791323|EG001|Reported Event|Soothe® XP|Mineral Oil Emollient
10946778|NCT00791388|BG000|Baseline|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
10946779|NCT00791388|BG001|Baseline|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
10946780|NCT00791388|BG002|Baseline|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
10946781|NCT00791388|BG003|Baseline|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
10946782|NCT00791388|BG004|Baseline|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
10946783|NCT00791388|BG005|Baseline|Total|Total of all reporting groups
10946784|NCT00791388|FG000|Participant Flow|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
10946785|NCT00791388|FG001|Participant Flow|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
10946786|NCT00791388|FG002|Participant Flow|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
10946787|NCT00791388|FG003|Participant Flow|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
10946788|NCT00791388|FG004|Participant Flow|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
10946789|NCT00791388|OG000|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
10946790|NCT00791388|OG001|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
10946791|NCT00791388|OG002|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
10946792|NCT00791388|OG003|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
10946793|NCT00791388|OG004|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
10946794|NCT00791388|EG000|Reported Event|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
10946795|NCT00791388|EG001|Reported Event|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
10946796|NCT00791388|EG002|Reported Event|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
10946797|NCT00791388|EG003|Reported Event|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
10946798|NCT00791388|EG004|Reported Event|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
10946799|NCT00791479|BG000|Baseline|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946800|NCT00791479|BG001|Baseline|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946801|NCT00791479|BG002|Baseline|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946802|NCT00791479|BG003|Baseline|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946803|NCT00791479|BG004|Baseline|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946804|NCT00791479|BG005|Baseline|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946805|NCT00791479|BG006|Baseline|Total|Total of all reporting groups
10946806|NCT00791479|FG000|Participant Flow|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946807|NCT00791479|FG001|Participant Flow|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946808|NCT00791479|FG002|Participant Flow|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
11192193|NCT02137603|EG000|Reported Event|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
10946809|NCT00791479|FG003|Participant Flow|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946810|NCT00791479|FG004|Participant Flow|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946811|NCT00791479|FG005|Participant Flow|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946812|NCT00791479|OG000|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
10946813|NCT00791479|OG001|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
10946814|NCT00791479|OG002|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
10946815|NCT00791479|OG003|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
10946816|NCT00791479|OG004|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
10946817|NCT00791479|OG000|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946818|NCT00791479|OG001|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946819|NCT00791479|OG002|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946820|NCT00791479|OG003|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946821|NCT00791479|OG004|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946822|NCT00791479|OG000|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
10946823|NCT00791479|OG004|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946824|NCT00791479|OG005|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946825|NCT00791479|EG000|Reported Event|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946826|NCT00791479|EG001|Reported Event|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946827|NCT00791479|EG002|Reported Event|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
11192194|NCT02137603|EG001|Reported Event|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
10946828|NCT00791479|EG003|Reported Event|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946829|NCT00791479|EG004|Reported Event|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946830|NCT00791479|EG005|Reported Event|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
10946831|NCT00791492|BG000|Baseline|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
10946832|NCT00791492|BG001|Baseline|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
10946833|NCT00791492|BG002|Baseline|Total|Total of all reporting groups
10946834|NCT00791492|FG000|Participant Flow|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
10946835|NCT00791492|FG001|Participant Flow|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
10946836|NCT00791492|OG000|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
10946837|NCT00791492|OG001|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
10946838|NCT00791492|EG000|Reported Event|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
10946839|NCT00791492|EG001|Reported Event|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
10946840|NCT00791518|BG000|Baseline|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
10946841|NCT00791518|FG000|Participant Flow|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
10946842|NCT00791518|OG000|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
10946843|NCT00791518|OG000|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
10946844|NCT00791518|OG001|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
11341725|NCT03687684|FG007|Participant Flow|Chinese Cohort 3: Placebo|TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
11341726|NCT03687684|FG008|Participant Flow|Chinese Cohort 3: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
10946845|NCT00791518|OG000|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <50%
10946846|NCT00791518|OG001|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
10946847|NCT00791518|OG000|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 <50%
10946848|NCT00791518|OG001|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 >=50%
10946849|NCT00791518|OG000|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
10946850|NCT00791518|OG001|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
10946851|NCT00791518|OG000|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
10946852|NCT00791518|OG001|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
10946853|NCT00791518|OG001|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
10946854|NCT00791518|OG000|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
10946855|NCT00791518|OG000|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and a an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
10946856|NCT00791518|OG002|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
10946857|NCT00791518|OG003|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
10946858|NCT00791518|EG000|Reported Event|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
10946859|NCT00791557|BG000|Baseline|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
10946860|NCT00791557|FG000|Participant Flow|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
10946861|NCT00791557|OG000|Outcome|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
10946862|NCT00791557|EG000|Reported Event|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
10946863|NCT00791648|BG000|Baseline|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
10946864|NCT00791648|BG001|Baseline|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
10946865|NCT00791648|BG002|Baseline|Total|Total of all reporting groups
10946866|NCT00791648|FG000|Participant Flow|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
10946867|NCT00791648|FG001|Participant Flow|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
10946868|NCT00791648|OG000|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
10946869|NCT00791648|OG001|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
10946870|NCT00791648|EG000|Reported Event|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
10946871|NCT00791648|EG001|Reported Event|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
11240733|NCT02481440|BG000|Baseline|hUC-MSC Transplantation|Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
10946872|NCT00791661|BG000|Baseline|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
10946873|NCT00791661|BG001|Baseline|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
10946874|NCT00791661|BG002|Baseline|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
10946875|NCT00791661|BG003|Baseline|Total|Total of all reporting groups
10946876|NCT00791661|FG000|Participant Flow|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
10946877|NCT00791661|FG001|Participant Flow|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
10946878|NCT00791661|FG002|Participant Flow|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
10946879|NCT00791661|OG000|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
10946880|NCT00791661|OG001|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
10946881|NCT00791661|OG002|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
10946882|NCT00791661|OG003|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
10946883|NCT00791661|OG004|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
10946884|NCT00791661|OG005|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
10946885|NCT00791661|OG006|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
10946886|NCT00791661|OG007|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
10946887|NCT00791661|OG008|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
10946888|NCT00791661|OG009|Outcome|Placebo|Participants received matching placebo to MK-1006
10946889|NCT00791661|OG010|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
10946890|NCT00791661|EG000|Reported Event|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
10946891|NCT00791661|EG001|Reported Event|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
10946892|NCT00791661|EG002|Reported Event|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
10946893|NCT00791661|EG003|Reported Event|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
10946894|NCT00791661|EG004|Reported Event|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
10946895|NCT00791661|EG005|Reported Event|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
10946896|NCT00791661|EG006|Reported Event|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
10946897|NCT00791661|EG007|Reported Event|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
10946898|NCT00791661|EG008|Reported Event|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
10946899|NCT00791661|EG009|Reported Event|Placebo|Participants received matching placebo to MK-1006
10946900|NCT00791661|EG010|Reported Event|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
10946901|NCT00791700|BG000|Baseline|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
10946902|NCT00791700|BG001|Baseline|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946903|NCT00791700|BG002|Baseline|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
10946904|NCT00791700|BG003|Baseline|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946905|NCT00791700|BG004|Baseline|Total|Total of all reporting groups
10946906|NCT00791700|FG000|Participant Flow|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 milligram per milliliter [mg/mL]).
10946907|NCT00791700|FG001|Participant Flow|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 milligram [mg], 75 mg, 150 mg).
10946908|NCT00791700|FG002|Participant Flow|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
10946909|NCT00791700|FG003|Participant Flow|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946910|NCT00791700|OG000|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
10946911|NCT00791700|OG001|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946912|NCT00791700|OG002|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
10946913|NCT00791700|OG003|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946914|NCT00791700|OG000|Outcome|Cohort 1 (Grade 3)|In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
10946915|NCT00791700|OG001|Outcome|Cohort 1 (Grade 4)|In cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20mg/mL).
10946916|NCT00791700|OG002|Outcome|Cohort 2 (Grade 3)|In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946917|NCT00791700|OG003|Outcome|Cohort 2 (Grade 4)|In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946918|NCT00791700|OG004|Outcome|Cohort 3 (Grade 3)|In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
10946919|NCT00791700|OG005|Outcome|Cohort 3 (Grade 4)|In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
10946920|NCT00791700|OG006|Outcome|Cohort 4 (Grade 3)|In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946921|NCT00791700|OG007|Outcome|Cohort 4 (Grade 4)|In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946922|NCT00791700|OG000|Outcome|Response|Participants with plasma HIV-1 RNA <48 copies/mL
10946923|NCT00791700|OG001|Outcome|PDVF|Participants who meet the protocol-defined virologic failure
10946924|NCT00791700|OG002|Outcome|Other Failure/Remainder|Participants with other failures
10946925|NCT00791700|EG000|Reported Event|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
10946926|NCT00791700|EG001|Reported Event|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946927|NCT00791700|EG002|Reported Event|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
10946928|NCT00791700|EG003|Reported Event|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
10946929|NCT00791765|BG000|Baseline|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
10946930|NCT00791765|BG001|Baseline|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
10946931|NCT00791765|BG002|Baseline|Total|Total of all reporting groups
10946932|NCT00791765|FG000|Participant Flow|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
11240734|NCT02481440|FG000|Participant Flow|hUC-MSC Transplantation|Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
10946933|NCT00791765|FG001|Participant Flow|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
10946934|NCT00791765|OG000|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
10946935|NCT00791765|OG001|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
10946936|NCT00791765|EG000|Reported Event|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
10946937|NCT00791765|EG001|Reported Event|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
10946938|NCT00791778|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
10946939|NCT00791778|BG001|Baseline|Placebo|Participants received 2 matching placebo tablets per oral twice daily
10946940|NCT00791778|BG002|Baseline|Total|Total of all reporting groups
10946941|NCT00791778|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
10946942|NCT00791778|FG001|Participant Flow|Placebo|Participants received 2 matching placebo tablets per oral twice daily
10946943|NCT00791778|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
10946944|NCT00791778|OG001|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
10946945|NCT00791778|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
10946946|NCT00791778|EG001|Reported Event|Placebo|Participants received 2 matching placebo tablets per oral twice daily
10946947|NCT00791817|BG000|Baseline|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
10946948|NCT00791817|BG001|Baseline|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
10946949|NCT00791817|BG002|Baseline|Total|Total of all reporting groups
10946950|NCT00791817|FG000|Participant Flow|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
10946951|NCT00791817|FG001|Participant Flow|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
10946952|NCT00791817|OG000|Outcome|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
10946953|NCT00791817|OG001|Outcome|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
10946954|NCT00791817|EG000|Reported Event|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
10946955|NCT00791817|EG001|Reported Event|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
10946956|NCT00791908|BG000|Baseline|Subjects|
10946957|NCT00791908|FG000|Participant Flow|Subjects|
10946958|NCT00791908|OG000|Outcome|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
10946959|NCT00791908|OG001|Outcome|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
10946960|NCT00791908|OG002|Outcome|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
10946961|NCT00791908|EG000|Reported Event|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
10946962|NCT00791908|EG001|Reported Event|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
10946963|NCT00791908|EG002|Reported Event|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
10946964|NCT00791921|BG000|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
10946965|NCT00791921|BG001|Baseline|Placebo|Placebo of CDP870
10946966|NCT00791921|BG002|Baseline|Total|Total of all reporting groups
10946967|NCT00791921|FG000|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
10946968|NCT00791921|FG001|Participant Flow|Placebo|Placebo of CDP870
10946969|NCT00791921|OG000|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
10946970|NCT00791921|OG001|Outcome|Placebo|Placebo of CDP870
10946971|NCT00791921|EG000|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
10946972|NCT00791921|EG001|Reported Event|Placebo|Placebo of CDP870
10946973|NCT00791934|BG000|Baseline|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
10946974|NCT00791934|FG000|Participant Flow|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days.
10946975|NCT00791934|OG000|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
10946976|NCT00791934|EG000|Reported Event|Stratus Microflow Ethmoid Spacer|Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
10946977|NCT00791973|BG000|Baseline|Veramyst, Then Placbeo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
10946978|NCT00791973|BG001|Baseline|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
10946979|NCT00791973|BG002|Baseline|Total|Total of all reporting groups
10946980|NCT00791973|FG000|Participant Flow|Veramyst, Then Placebo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
10946981|NCT00791973|FG001|Participant Flow|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
10946982|NCT00791973|OG000|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
10946983|NCT00791973|OG001|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
10946984|NCT00791973|EG000|Reported Event|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
10946985|NCT00791973|EG001|Reported Event|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
10946986|NCT00791999|BG000|Baseline|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
10946987|NCT00791999|BG001|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
10946988|NCT00791999|BG002|Baseline|CDP870 400mg|400mg CDP870 given every 2 weeks
10946989|NCT00791999|BG003|Baseline|Placebo|Placebo given every 2 weeks
10946990|NCT00791999|BG004|Baseline|Total|Total of all reporting groups
10946991|NCT00791999|FG000|Participant Flow|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
10946992|NCT00791999|FG001|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
10946993|NCT00791999|FG002|Participant Flow|CDP870 400mg|400mg CDP870 given every 2 weeks
10946994|NCT00791999|FG003|Participant Flow|Placebo|Placebo given every 2 weeks
10946995|NCT00791999|OG000|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
10946996|NCT00791999|OG001|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
10946997|NCT00791999|OG002|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
10946998|NCT00791999|OG003|Outcome|Placebo|Placebo given every 2 weeks
10946999|NCT00791999|EG000|Reported Event|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
10947000|NCT00791999|EG001|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
10947001|NCT00791999|EG002|Reported Event|CDP870 400mg|400mg CDP870 given every 2 weeks
10947002|NCT00791999|EG003|Reported Event|Placebo|Placebo given every 2 weeks
10947003|NCT00792077|BG000|Baseline|Lenalidomide|Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
10947004|NCT00792077|FG000|Participant Flow|Lenalidomide|Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
10947005|NCT00792077|OG000|Outcome|Lenalidomide|Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
10947006|NCT00792077|EG000|Reported Event|Lenalidomide|Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
10947007|NCT00792103|BG000|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
10947008|NCT00792103|FG000|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
10947009|NCT00792103|OG000|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
10947010|NCT00792103|EG000|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
10947011|NCT00792142|BG000|Baseline|Treatment (Stem Cell Transplant, Maintenance Treatment)|Patients receive high-dose melphalan IV 200mg/m^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
10947012|NCT00792142|FG000|Participant Flow|Treatment (Stem Cell Transplant, Maintenance Treatment)|Patients receive high-dose melphalan IV 200mg/m^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
10947013|NCT00792142|OG000|Outcome|Treatment (Stem Cell Transplant, Maintenance Treatment)|Patients receive high-dose melphalan IV 200mg/m^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
10947014|NCT00792142|EG000|Reported Event|Treatment (Stem Cell Transplant, Maintenance Treatment)|Patients receive high-dose melphalan IV 200mg/m^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
10947015|NCT00792298|BG000|Baseline|All Treated Participants|All randomized participants who received at least one dose of study treatment.
10947016|NCT00792298|FG000|Participant Flow|Suvorexant 10 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
10947017|NCT00792298|FG001|Participant Flow|Placebo → Suvorexant 10 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
10947018|NCT00792298|FG002|Participant Flow|Suvorexant 20 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
10947019|NCT00792298|FG003|Participant Flow|Placebo → Suvorexant 20 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
10947020|NCT00792298|FG004|Participant Flow|Suvorexant 40 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
10947021|NCT00792298|FG005|Participant Flow|Placebo → Suvorexant 40 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
10947022|NCT00792298|FG006|Participant Flow|Suvorexant 80 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
10947023|NCT00792298|FG007|Participant Flow|Placebo → Suvorexant 80 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.
10947024|NCT00792298|OG000|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
10947025|NCT00792298|OG001|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
10947026|NCT00792298|OG002|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
10947027|NCT00792298|OG003|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
10947028|NCT00792298|OG004|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
10947029|NCT00792298|OG000|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
10947030|NCT00792298|OG001|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
10947031|NCT00792298|OG002|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
10947032|NCT00792298|OG003|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
10947033|NCT00792298|OG004|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
10947034|NCT00792298|EG000|Reported Event|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
10947035|NCT00792298|EG001|Reported Event|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
10947036|NCT00792298|EG002|Reported Event|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
10947037|NCT00792298|EG003|Reported Event|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
10947038|NCT00792298|EG004|Reported Event|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
10947039|NCT00792428|BG000|Baseline|Real-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.~Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue"
10947040|NCT00792428|BG001|Baseline|Sham-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.~Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue."
10947041|NCT00792428|BG002|Baseline|Total|Total of all reporting groups
10947042|NCT00792428|FG000|Participant Flow|Real-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.~Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue"
10947043|NCT00792428|FG001|Participant Flow|Sham-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.~Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue."
10947044|NCT00792428|OG000|Outcome|Real-tDCS + PT-OT|Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
11177744|NCT02043379|EG001|Reported Event|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
10947045|NCT00792428|OG001|Outcome|Sham-tDCS + PT-OT|Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
10947046|NCT00792428|EG000|Reported Event|Real-tDCS + PT-OT|Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
10947047|NCT00792428|EG001|Reported Event|Sham tDCS + PT-OT|Subjects are receiving sham tDCS in a dual configuration over both motor regions for 30 minutes while they are also receiving PT-OT for 60 minutes
10947048|NCT00792467|BG000|Baseline|ITF2357|"Patients will receive the following therapy cycle~ITF2357, 50 mg every 6 hours, per os, days 1 - 3;~Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy will be administered every 21 days as long as there is no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycles.~ITF2357: ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each."
10947049|NCT00792467|FG000|Participant Flow|ITF2357|"Patients received the following therapy cycle~ITF2357, 50 mg every 6 hours, per os, days 1 - 3;~Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy was administered every 21 days as long as there is no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycles.~ITF2357: ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each."
10947050|NCT00792467|OG000|Outcome|ITT Population|"Patients received the following therapy cycle~ITF2357, 50 mg every 6 hours, per os, days 1 - 3;~Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy was administered every 21 days as long as there is no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycles.~ITF2357: ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each."
10947051|NCT00792467|OG001|Outcome|PP Population|"Patients received the following therapy cycle~ITF2357, 50 mg every 6 hours, per os, days 1 - 3;~Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy was administered every 21 days as long as there is no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycles.~ITF2357: ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each."
10947052|NCT00792467|EG000|Reported Event|ITF2357|"Patients will receive the following therapy cycle~ITF2357, 50 mg every 6 hours, per os, days 1 - 3;~Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy will be administered every 21 days as long as there is no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycles.~ITF2357: ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each."
10947053|NCT00792571|BG000|Baseline|Beraprost Sodium|Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)
10947054|NCT00792571|FG000|Participant Flow|Beraprost Sodium|Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)
10947055|NCT00792571|OG000|Outcome|Beraprost Sodium|Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)
10947056|NCT00792571|EG000|Reported Event|Beraprost Sodium|Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)
10947057|NCT00792610|BG000|Baseline|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
10947058|NCT00792610|FG000|Participant Flow|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
10947059|NCT00792610|OG000|Outcome|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
10947060|NCT00792610|EG000|Reported Event|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
10947061|NCT00792623|BG000|Baseline|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltoid region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
10947062|NCT00792623|FG000|Participant Flow|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltoid region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
10947063|NCT00792623|OG000|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltoid region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
10947064|NCT00792623|OG000|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
10947065|NCT00792623|EG000|Reported Event|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltoid region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
10947066|NCT00792636|BG000|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
10947067|NCT00792636|BG001|Baseline|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
10947068|NCT00792636|BG002|Baseline|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
10947069|NCT00792636|BG003|Baseline|Total|Total of all reporting groups
10947070|NCT00792636|FG000|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
10947071|NCT00792636|FG001|Participant Flow|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
10947072|NCT00792636|FG002|Participant Flow|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
10947073|NCT00792636|OG000|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
10947074|NCT00792636|OG001|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
11177745|NCT02043509|BG000|Baseline|MiQuit|"12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care~MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement."
11177746|NCT02043509|BG001|Baseline|Control|Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
11177747|NCT02043509|BG002|Baseline|Total|Total of all reporting groups
11177748|NCT02043509|FG000|Participant Flow|MiQuit|"12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care~MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement."
11177749|NCT02043509|FG001|Participant Flow|Control|Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
11177750|NCT02043509|OG000|Outcome|MiQuit|"12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care~MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement."
11177751|NCT02043509|OG001|Outcome|Control|Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
11177752|NCT02043509|EG000|Reported Event|MiQuit|"12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care~MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement."
11177753|NCT02043509|EG001|Reported Event|Control|Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
11177754|NCT02043548|BG000|Baseline|Group A: Tocilizumab|"Tocilizumab will be given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).~tocilizumab: given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6)."
11177755|NCT02043548|BG001|Baseline|Group B: Placebo|"Placebo arm - no active drug~placebo: given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6)."
11177756|NCT02043548|BG002|Baseline|Total|Total of all reporting groups
11177757|NCT02043548|FG000|Participant Flow|Group A: Tocilizumab|"Tocilizumab will be given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).~tocilizumab: given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6)."
11177758|NCT02043548|FG001|Participant Flow|Group B: Placebo|"Placebo arm - no active drug~placebo: given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6)."
11177759|NCT02043548|OG000|Outcome|Group A: Tocilizumab|"Tocilizumab will be given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).~tocilizumab: given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6)."
11177760|NCT02043548|OG001|Outcome|Group B: Placebo|"Placebo arm - no active drug~placebo: given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6)."
11177761|NCT02043548|EG000|Reported Event|Group A: Tocilizumab|"Tocilizumab will be given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).~tocilizumab: given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6)."
11177762|NCT02043548|EG001|Reported Event|Group B: Placebo|"Placebo arm - no active drug~placebo: given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6)."
11177763|NCT02043574|BG000|Baseline|Stretching (Control)|"Six months of stretching~Stretching (control): Stretch controls will be enrolled in supervised stretching program for 2 days/week for 1 hour sessions. The stretch program will focus on basic mobility skills, including balance, endurance, sit-to-stand, weight shifting, and truncal stability-coordination. Stretching will be done in groups up to 6 participants. Exercises will be performed in standing, seated, and lying positions."
11177764|NCT02043574|BG001|Baseline|Treadmill Exercise|"Six months of treadmill training~Treadmill Exercise: Training will occur 3 days/week and will be started conservatively with a goal of 15 minutes total duration at 40-50% HRR. Training target HR = %(HRmax - HRrest) + HRrest. Individuals unable to walk continuously will exercise intermittently for several minutes as tolerated, with rest intervals, and advanced as tolerated with HR, blood pressure monitoring, and Borg Perceived Exertion to assess subjective cardiopulmonary exercise tolerance. Treadmill training velocity will advance as tolerated by week 6 to a target intensity of 70-80% maximal HRR. Duration will similarly advance to a target of 30 minutes by week 6. Following week 6, the progressive training protocol will continue with attempts to increase velocity on a weekly basis and increase duration by 5 minutes bi-weekly to peak at 50 minutes. After week 6, the target HR goal will be 75-85% of HRR as tolerated by the subject."
11177765|NCT02043574|BG002|Baseline|Total|Total of all reporting groups
11177766|NCT02043574|FG000|Participant Flow|Stretching (Control)|"Six months of stretching~Stretching (control): Stretch controls will be enrolled in supervised stretching program for 2 days/week for 1 hour sessions. The stretch program will focus on basic mobility skills, including balance, endurance, sit-to-stand, weight shifting, and truncal stability-coordination. Stretching will be done in groups up to 6 participants. Exercises will be performed in standing, seated, and lying positions."
11240735|NCT02481440|OG000|Outcome|hUC-MSC Transplantation|Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
10947075|NCT00792636|OG000|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
11240736|NCT02481440|EG000|Reported Event|hUC-MSC Transplantation|Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
10947076|NCT00792636|OG001|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
10947077|NCT00792636|OG002|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
10947078|NCT00792636|EG000|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
10947079|NCT00792636|EG001|Reported Event|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
10947080|NCT00792636|EG002|Reported Event|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
10947081|NCT00792688|BG000|Baseline|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947082|NCT00792688|BG001|Baseline|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947083|NCT00792688|BG002|Baseline|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947084|NCT00792688|BG003|Baseline|Total|Total of all reporting groups
10947085|NCT00792688|FG000|Participant Flow|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947086|NCT00792688|FG001|Participant Flow|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947087|NCT00792688|FG002|Participant Flow|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947088|NCT00792688|OG000|Outcome|All Treatments GLYC-101 Gel, 0.1%|
10947089|NCT00792688|OG001|Outcome|All Treatments GLYC-101 Gel, 1.0%|
10947090|NCT00792688|OG002|Outcome|All Treatments Placebo|
10947091|NCT00792688|EG000|Reported Event|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947092|NCT00792688|EG001|Reported Event|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947093|NCT00792688|EG002|Reported Event|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
10947094|NCT00792701|BG000|Baseline|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.~Active surveillance: Patients undergo active monitoring"
10947095|NCT00792701|BG001|Baseline|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV"
10947096|NCT00792701|BG002|Baseline|Total|Total of all reporting groups
10947097|NCT00792701|FG000|Participant Flow|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.~Active surveillance: Patients undergo active monitoring"
10947098|NCT00792701|FG001|Participant Flow|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV"
11192195|NCT02137772|BG000|Baseline|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
10947099|NCT00792701|OG000|Outcome|All Eligible Patients|All patients who received a treatment assignment within the prespecified timeframe.
10947100|NCT00792701|OG000|Outcome|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.~Active surveillance: Patients undergo active monitoring"
11192196|NCT02137772|BG001|Baseline|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
11192197|NCT02137772|BG002|Baseline|Total|Total of all reporting groups
11177767|NCT02043574|FG001|Participant Flow|Treadmill Exercise|"Six months of treadmill training~Treadmill Exercise: Training will occur 3 days/week and will be started conservatively with a goal of 15 minutes total duration at 40-50% HRR. Training target HR = %(HRmax - HRrest) + HRrest. Individuals unable to walk continuously will exercise intermittently for several minutes as tolerated, with rest intervals, and advanced as tolerated with HR, blood pressure monitoring, and Borg Perceived Exertion to assess subjective cardiopulmonary exercise tolerance. Treadmill training velocity will advance as tolerated by week 6 to a target intensity of 70-80% maximal HRR. Duration will similarly advance to a target of 30 minutes by week 6. Following week 6, the progressive training protocol will continue with attempts to increase velocity on a weekly basis and increase duration by 5 minutes bi-weekly to peak at 50 minutes. After week 6, the target HR goal will be 75-85% of HRR as tolerated by the subject."
11177768|NCT02043574|OG000|Outcome|Stretching (Control)|"Six months of stretching~Stretching (control): Stretch controls will be enrolled in supervised stretching program for 2 days/week for 1 hour sessions. The stretch program will focus on basic mobility skills, including balance, endurance, sit-to-stand, weight shifting, leg strength, and truncal stability-coordination. Stretching will be done in groups up to 6 participants. Exercises will be performed in standing, seated, and lying positions. A log book on the stretching exercise participation and progression will be maintained and reviewed by the instructor with the participant at each session."
11177769|NCT02043574|OG001|Outcome|Treadmill Exercise|"Six months of treadmill training~Treadmill Exercise: Training will be started conservatively with a goal of 15 minutes total duration at 40-50% HRR. Training target HR = %(HRmax - HRrest) + HRrest. Treadmill training velocity will advance as tolerated by week 6 to a target intensity of 70-80% maximal HRR. Duration will similarly advance to a target of 30 minutes by week 6. Following week 6, the progressive training protocol will continue with attempts to increase velocity on a weekly basis and increase duration by 5 minutes bi-weekly to peak at 50 minutes. After week 6, the target HR goal will be 75-85% of HRR as tolerated."
11177770|NCT02043574|OG001|Outcome|Treadmill Exercise|Six months of treadmill training Treadmill Exercise: Training will be started conservatively with a goal of 15 minutes total duration at 40-50% HRR. Training target HR = %(HRmax - HRrest) + HRrest. Treadmill training velocity will advance as tolerated by week 6 to a target intensity of 70-80% maximal HRR. Duration will similarly advance to a target of 30 minutes by week 6. Following week 6, the progressive training protocol will continue with attempts to increase velocity on a weekly basis and increase duration by 5 minutes bi-weekly to peak at 50 minutes. After week 6, the target HR goal will be 75-85% of HRR as tolerated.
11177771|NCT02043574|EG000|Reported Event|Stretching (Control)|"Six months of stretching~Stretching (control): Stretch controls will be enrolled in supervised stretching program for 2 days/week for 1 hour sessions. The stretch program will focus on basic mobility skills, including balance, endurance, sit-to-stand, weight shifting, leg strength, and truncal stability-coordination. Stretching will be done in groups up to 6 participants. Exercises will be performed in standing, seated, and lying positions. A log book on the stretching exercise participation and progression will be maintained and reviewed by the instructor with the participant at each session."
11177772|NCT02043574|EG001|Reported Event|Treadmill Exercise|"Six months of treadmill training~Treadmill Exercise: Training will be started conservatively with a goal of 15 minutes total duration at 40-50% HRR. Training target HR = %(HRmax - HRrest) + HRrest. Treadmill training velocity will advance as tolerated by week 6 to a target intensity of 70-80% maximal HRR. Duration will similarly advance to a target of 30 minutes by week 6. Following week 6, the progressive training protocol will continue with attempts to increase velocity on a weekly basis and increase duration by 5 minutes bi-weekly to peak at 50 minutes. After week 6, the target HR goal will be 75-85% of HRR as tolerated."
11177773|NCT02043652|BG000|Baseline|Chlorquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
11177774|NCT02043652|FG000|Participant Flow|Chloroquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
11177775|NCT02043652|OG000|Outcome|Chlorquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
11177776|NCT02043652|EG000|Reported Event|Chlorquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
11240737|NCT02481505|BG000|Baseline|3 mL Chloroprocaine HCl 1%|"Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
11177777|NCT02043704|BG000|Baseline|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
11177778|NCT02043704|BG001|Baseline|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
11177779|NCT02043704|BG002|Baseline|Total|Total of all reporting groups
11177780|NCT02043704|FG000|Participant Flow|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
11177781|NCT02043704|FG001|Participant Flow|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
10947101|NCT00792701|OG001|Outcome|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV"
10947102|NCT00792701|OG000|Outcome|Gemcitabine Hydrochloride and Cisplatin|Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
11177782|NCT02043704|OG000|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
11177783|NCT02043704|OG001|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
11177784|NCT02043704|EG000|Reported Event|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
11177785|NCT02043704|EG001|Reported Event|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
11177786|NCT02043782|BG000|Baseline|All Subjects|Pooled data from all arms.
11177787|NCT02043782|FG000|Participant Flow|Test - Competitor - Own|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Coloplast test product Competitor soft convex product Own product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject's own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
11177788|NCT02043782|FG001|Participant Flow|Competitor - Own - Test|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Competitor soft convex product Own product Coloplast test product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
11177789|NCT02043782|FG002|Participant Flow|Own - Test - Competitor|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Own product Coloplast test product Competitor soft convex product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
11177790|NCT02043782|FG003|Participant Flow|Competitor - Test - Own|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Competitor soft convex product Coloplast test product Own product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
11192198|NCT02137772|FG000|Participant Flow|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
10947103|NCT00792701|OG000|Outcome|All Patients|All registered patients.
10947104|NCT00792701|EG000|Reported Event|Gemcitabine Hydrochloride and Cisplatin|Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10947105|NCT00792805|BG000|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947106|NCT00792805|BG001|Baseline|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947107|NCT00792805|BG002|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947108|NCT00792805|BG003|Baseline|Total|Total of all reporting groups
10947109|NCT00792805|FG000|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947110|NCT00792805|FG001|Participant Flow|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947111|NCT00792805|FG002|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947112|NCT00792805|OG000|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947113|NCT00792805|OG001|Outcome|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947114|NCT00792805|OG002|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947115|NCT00792805|EG000|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947116|NCT00792805|EG001|Reported Event|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947117|NCT00792805|EG002|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947118|NCT00792909|BG000|Baseline|Synflorix™ Group 1|Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
10947119|NCT00792909|BG001|Baseline|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
10947120|NCT00792909|BG002|Baseline|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
10947121|NCT00792909|BG003|Baseline|Total|Total of all reporting groups
10947122|NCT00792909|FG000|Participant Flow|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
11192199|NCT02137772|FG001|Participant Flow|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
10947123|NCT00792909|FG001|Participant Flow|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
10947124|NCT00792909|FG002|Participant Flow|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
10947125|NCT00792909|OG000|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
10947126|NCT00792909|OG000|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
10947127|NCT00792909|OG001|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
10947128|NCT00792909|OG001|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
10947129|NCT00792909|OG000|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
10947130|NCT00792909|OG002|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
10947131|NCT00792909|EG000|Reported Event|Synflorix™ Group 1|Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
10947132|NCT00792909|EG001|Reported Event|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
10947133|NCT00792909|EG002|Reported Event|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
10947134|NCT00792922|BG000|Baseline|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
10947135|NCT00792922|BG001|Baseline|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
10947136|NCT00792922|BG002|Baseline|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947137|NCT00792922|BG003|Baseline|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947138|NCT00792922|BG004|Baseline|Total|Total of all reporting groups
10947139|NCT00792922|FG000|Participant Flow|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
10947140|NCT00792922|FG001|Participant Flow|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
10947141|NCT00792922|FG002|Participant Flow|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947142|NCT00792922|FG003|Participant Flow|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947143|NCT00792922|OG000|Outcome|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
11240738|NCT02481505|BG001|Baseline|4 mL Chloroprocaine HCl 1%|"Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947144|NCT00792922|OG001|Outcome|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
10947145|NCT00792922|OG002|Outcome|≥90% Coveage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947146|NCT00792922|OG003|Outcome|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947147|NCT00792922|OG002|Outcome|≥90% Coveage With Azithromycin, Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
11341727|NCT03687684|OG000|Outcome|Japanese Cohort 1: Placebo|TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
10947148|NCT00792922|OG003|Outcome|80%-89% Coverage With Azithromycin: Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947149|NCT00792922|EG000|Reported Event|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
10947150|NCT00792922|EG001|Reported Event|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
10947151|NCT00792922|EG002|Reported Event|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947152|NCT00792922|EG003|Reported Event|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
10947153|NCT00792935|BG000|Baseline|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
10947154|NCT00792935|BG001|Baseline|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
10947155|NCT00792935|BG002|Baseline|Total|Total of all reporting groups
10947156|NCT00792935|FG000|Participant Flow|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
10947157|NCT00792935|FG001|Participant Flow|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
10947158|NCT00792935|OG000|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
10947159|NCT00792935|OG001|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
10947160|NCT00792935|EG000|Reported Event|MK-0941|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941.
10947161|NCT00792935|EG001|Reported Event|Glimepiride|All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.
10947162|NCT00793104|BG000|Baseline|CR Plug|Placement of allograft CR Plug in primary injury site
10947163|NCT00793104|FG000|Participant Flow|CR Plug|Placement of allograft CR Plug in primary injury site
10947164|NCT00793104|OG000|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
10947165|NCT00793104|EG000|Reported Event|CR Plug|Placement of allograft CR Plug in primary injury site
10947166|NCT00793182|BG000|Baseline|IodixanoI|Patients randomized to receive iodixanol 320 mgI/mL.
10947167|NCT00793182|BG001|Baseline|IoversoI|Patients randomized to receive ioversol 320 mgI/mL.
10947168|NCT00793182|BG002|Baseline|Total|Total of all reporting groups
11240739|NCT02481505|BG002|Baseline|5 mL Chloroprocaine HCl 1%|"Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
11240740|NCT02481505|BG003|Baseline|Total|Total of all reporting groups
10947169|NCT00793182|FG000|Participant Flow|Iodixanol|Patients randomized to receive Iodixanol 320 mgI/mL.
10947170|NCT00793182|FG001|Participant Flow|Ioversol|Patients randomized to receive Ioversol 320 mgI/mL.
10947171|NCT00793182|OG000|Outcome|Iodixanol|Patients who received iodixanol
10947172|NCT00793182|OG001|Outcome|IoversoI|Patients who received ioversol
10947173|NCT00793182|EG000|Reported Event|Iodixanol|Patients who received iodixanol 320 mgI/mL.
10947174|NCT00793182|EG001|Reported Event|Ioversol|Patients who received ioversol 320 mgI/mL.
10947175|NCT00793325|BG000|Baseline|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
10947176|NCT00793325|FG000|Participant Flow|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
10947177|NCT00793325|OG000|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
10947178|NCT00793325|OG000|Outcome|<15 Years|Participants younger than 15 years of age when taking somatropin for SGA according to Japanese package insert.
10947179|NCT00793325|OG001|Outcome|>=15 Years|Participants 15 years of age or older when taking somatropin for SGA according to Japanese package insert.
10947180|NCT00793325|OG000|Outcome|Male|Male Participants taking somatropin for SGA according to Japanese package insert.
10947181|NCT00793325|OG001|Outcome|Female|Female Participants taking somatropin for SGA according to Japanese package insert.
10947182|NCT00793325|OG000|Outcome|Mild SGA|Participants with mild SGA taking somatropin for SGA according to Japanese package insert.
10947183|NCT00793325|OG001|Outcome|Moderate SGA|Participants with moderate SGA taking somatropin for SGA according to Japanese package insert.
10947184|NCT00793325|OG002|Outcome|Severe SGA|Participants with severe SGA taking somatropin for SGA according to Japanese package insert.
10947185|NCT00793325|OG000|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for SGA according to Japanese package insert.
10947186|NCT00793325|OG001|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for SGA according to Japanese package insert.
10947187|NCT00793325|OG000|Outcome|Participants With Complication(s)|Participants with complication(s) while taking somatropin for SGA according to Japanese package insert.
10947188|NCT00793325|OG001|Outcome|Participants Without Complication(s)|Participants without complications while taking somatropin for SGA according to Japanese package insert.
10947189|NCT00793325|OG000|Outcome|Participants With Hepatic Function Disorder|Participants with hepatic function disorder taking somatropin for SGA according to Japanese package insert.
10947190|NCT00793325|OG001|Outcome|Participants Without Hepatic Function Disorder|Participants without hepatic function disorder taking somatropin for SGA according to Japanese package insert.
11240741|NCT02481505|FG000|Participant Flow|3 mL Chloroprocaine HCl 1%|"Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947191|NCT00793325|OG000|Outcome|Participants With Renal Impairment|Participants with renal impairment taking somatropin for SGA according to Japanese package insert.
10947192|NCT00793325|OG001|Outcome|Participants Without Renal Impairment|Participants without renal impairment taking somatropin for SGA according to Japanese package insert.
10947193|NCT00793325|OG000|Outcome|Participants With Concomitant Drug(s)|Participants taking concomitant drug(s) while taking somatropin for SGA according to Japanese package insert.
10947194|NCT00793325|OG001|Outcome|Participants Without Concomitant Drug(s)|Participants taking no concomitant drugs while taking somatropin for SGA according to Japanese package insert.
10947195|NCT00793325|OG000|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the growth rate SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
10947196|NCT00793325|OG000|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the height SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
10947197|NCT00793325|EG000|Reported Event|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
10947198|NCT00793403|BG000|Baseline|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
10947199|NCT00793403|FG000|Participant Flow|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
10947200|NCT00793403|OG000|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
10947201|NCT00793403|EG000|Reported Event|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
10947202|NCT00793455|BG000|Baseline|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
10947203|NCT00793455|BG001|Baseline|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
10947204|NCT00793455|BG002|Baseline|Total|Total of all reporting groups
10947205|NCT00793455|FG000|Participant Flow|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
10947206|NCT00793455|FG001|Participant Flow|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
10947207|NCT00793455|OG000|Outcome|Usual Care Control Group|Usual Care
10947208|NCT00793455|OG001|Outcome|Intervention Group|Received Educational Outreach
10947209|NCT00793455|OG001|Outcome|Intervention Group|Received outreach intervention
10947210|NCT00793455|EG000|Reported Event|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
11177791|NCT02043782|FG004|Participant Flow|Own - Competitor - Test|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Own product Competitor soft convex product Coloplast test product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
11177792|NCT02043782|FG005|Participant Flow|Test - Own - Competitor|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Coloplast test product Own product Competitor soft convex product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
11177793|NCT02043782|OG000|Outcome|Coloplast Test Product|Subjects testing Coloplast test product
11177794|NCT02043782|OG001|Outcome|Own Product|Subjects testing own product
11177795|NCT02043782|OG002|Outcome|Competitor Soft Convex|Subjects testing Competitor Soft Convex
11177796|NCT02043782|EG000|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
11177797|NCT02043782|EG001|Reported Event|Own Product|Adverse events reported by subjects testing own product
11177798|NCT02043782|EG002|Reported Event|Competitor Soft Convex|Adverse events reported by subjects testing Competitor soft convex
11177799|NCT02043808|BG000|Baseline|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
11177800|NCT02043808|BG001|Baseline|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
11177801|NCT02043808|BG002|Baseline|Total|Total of all reporting groups
11177802|NCT02043808|FG000|Participant Flow|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
11177803|NCT02043808|FG001|Participant Flow|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
11177804|NCT02043808|OG000|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
11177805|NCT02043808|OG001|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
11177806|NCT02043808|EG000|Reported Event|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
11177807|NCT02043808|EG001|Reported Event|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
11240742|NCT02481505|FG001|Participant Flow|4 mL Chloroprocaine HCl 1%|"Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947211|NCT00793455|EG001|Reported Event|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
10947212|NCT00793546|BG000|Baseline|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947213|NCT00793546|BG001|Baseline|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947214|NCT00793546|BG002|Baseline|Total|Total of all reporting groups
10947215|NCT00793546|FG000|Participant Flow|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947216|NCT00793546|FG001|Participant Flow|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947217|NCT00793546|OG000|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947218|NCT00793546|OG001|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
10947219|NCT00793546|OG000|Outcome|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947220|NCT00793546|OG001|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947221|NCT00793546|EG000|Reported Event|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947222|NCT00793546|EG001|Reported Event|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
10947223|NCT00793572|BG000|Baseline|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
10947224|NCT00793572|FG000|Participant Flow|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
11240743|NCT02481505|FG002|Participant Flow|5 mL Chloroprocaine HCl 1%|"Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947225|NCT00793572|OG000|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
10947226|NCT00793572|EG000|Reported Event|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
10947227|NCT00793585|BG000|Baseline|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
10947228|NCT00793585|BG001|Baseline|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
10947229|NCT00793585|BG002|Baseline|Total|Total of all reporting groups
10947230|NCT00793585|FG000|Participant Flow|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
10947231|NCT00793585|FG001|Participant Flow|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
10947232|NCT00793585|OG000|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
10947233|NCT00793585|OG001|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
10947234|NCT00793585|EG000|Reported Event|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
10947235|NCT00793585|EG001|Reported Event|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
10947236|NCT00793598|BG000|Baseline|10 mg BCV BIW|Subjects who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
10947237|NCT00793598|BG001|Baseline|20 mg BCV QW|Subjects who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
10947238|NCT00793598|BG002|Baseline|Placebo BIW|Subjects who received placebo twice weekly (BIW) under Amendment 2.
10947239|NCT00793598|BG003|Baseline|40 mg BCV QW|Subjects who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0 7, 14, 21, and 28.
10947240|NCT00793598|BG004|Baseline|Placebo QW|Subjects who received placebo once weekly (QW) under Amendment 3.
10947241|NCT00793598|BG005|Baseline|Total|Total of all reporting groups
11240744|NCT02481505|OG000|Outcome|3 mL Chloroprocaine HCl 1%|"Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947242|NCT00793598|FG000|Participant Flow|10 mg BCV BIW RT|Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
10947243|NCT00793598|FG001|Participant Flow|10 mg BCV BIW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
10947244|NCT00793598|FG002|Participant Flow|20 mg BCV QW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
10947245|NCT00793598|FG003|Participant Flow|Placebo BIW HCT|Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
10947246|NCT00793598|FG004|Participant Flow|40 mg BCV QW RT|Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
10947247|NCT00793598|FG005|Participant Flow|40 mg BCV QW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
10947248|NCT00793598|FG006|Participant Flow|Placebo QW RT|Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
10947249|NCT00793598|FG007|Participant Flow|Placebo QW HCT|Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
10947250|NCT00793598|OG000|Outcome|10 mg BCV BIW RT|Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly
10947251|NCT00793598|OG001|Outcome|10 mg BCV BIW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
10947252|NCT00793598|OG002|Outcome|20 mg BCV BIW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
10947253|NCT00793598|OG003|Outcome|Placebo BIW HCT|Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
10947254|NCT00793598|OG004|Outcome|40 mg BCV QW RT|Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
10947255|NCT00793598|OG005|Outcome|40 mg BCV QW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
10947256|NCT00793598|OG006|Outcome|Placebo QW RT|Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
10947257|NCT00793598|OG007|Outcome|Placebo QW HCT|Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
10947258|NCT00793598|OG000|Outcome|40 mg BCV QW|Subjects who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
10947259|NCT00793598|OG001|Outcome|Placebo|Subjects who received placebo once weekly (QW) on Days 0, 7, 14, 21 and 28.
10947260|NCT00793598|OG000|Outcome|40 mg BCV QW|Subjects randomized to receive 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
10947261|NCT00793598|OG001|Outcome|Placebo QW|Subjects who received placebo once weekly (QW) on Days 0, 7, 14, 21 and 28.
10947262|NCT00793598|EG000|Reported Event|10 mg BCV BIW RT|Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
10947263|NCT00793598|EG001|Reported Event|10 mg BCV BIW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
10947264|NCT00793598|EG002|Reported Event|20 mg BCV QW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
10947265|NCT00793598|EG003|Reported Event|Placebo BIW HCT|Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
10947266|NCT00793598|EG004|Reported Event|40 mg BCV QW RT|Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
10947267|NCT00793598|EG005|Reported Event|40 mg BCV QW HCT|Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
10947268|NCT00793598|EG006|Reported Event|Placebo QW RT|Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
10947269|NCT00793598|EG007|Reported Event|Placebo QW HCT|Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
10947270|NCT00793611|BG000|Baseline|Behavioral Therapy Standard Care|received 3 behavioral therapy session
10947271|NCT00793611|BG001|Baseline|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
10947272|NCT00793611|BG002|Baseline|Total|Total of all reporting groups
10947273|NCT00793611|FG000|Participant Flow|Behavioral Therapy Standard Care|received 3 behavioral therapy session
10947274|NCT00793611|FG001|Participant Flow|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
10947275|NCT00793611|OG000|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
10947276|NCT00793611|OG001|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
10947277|NCT00793611|EG000|Reported Event|Behavioral Therapy Standard Care|received 3 behavioral therapy session
11177808|NCT02043899|BG000|Baseline|Single Arm Trial|[124I]meta-Iodobenzylguanidine: Single intravenous administration of [124I]mIBG Solution for Injection on Day 1 with a maximum radioactive dose of 1.42 MBq/kg (±10%) and a maximum injected dose of 50 MBq [124I]mIBG equating to a maximum chemical dose of 10 micrograms of stable mIBG. The activity to paediatric patients will be scaled by weight based upon the EANM paediatric dose card (Lassmann et al., 2007). This will result in an activity between 10 MBq and 50 MBq depending on the patient's weight.
11177809|NCT02043899|FG000|Participant Flow|Single Arm Trial|[124I]meta-Iodobenzylguanidine: Single intravenous administration of [124I]mIBG Solution for Injection on Day 1 with a maximum radioactive dose of 1.42 MBq/kg (±10%) and a maximum injected dose of 50 MBq [124I]mIBG equating to a maximum chemical dose of 10 micrograms of stable mIBG. The activity to paediatric patients will be scaled by weight based upon the EANM paediatric dose card (Lassmann et al., 2007). This will result in an activity between 10 MBq and 50 MBq depending on the patient's weight.
10947278|NCT00793611|EG001|Reported Event|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
10947279|NCT00793624|BG000|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10947280|NCT00793624|BG001|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10947281|NCT00793624|BG002|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10947282|NCT00793624|BG003|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10947283|NCT00793624|BG004|Baseline|Total|Total of all reporting groups
10947284|NCT00793624|FG000|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10947285|NCT00793624|FG001|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10947286|NCT00793624|FG002|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10947287|NCT00793624|FG003|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10947288|NCT00793624|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10947289|NCT00793624|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10947290|NCT00793624|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10947291|NCT00793624|OG003|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10947292|NCT00793624|OG000|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
10947293|NCT00793624|OG001|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
10947294|NCT00793624|OG002|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
10947295|NCT00793624|OG003|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
10947296|NCT00793624|OG004|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
10947297|NCT00793624|OG005|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
10947298|NCT00793624|OG006|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
10947299|NCT00793624|OG007|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
10947300|NCT00793624|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10947301|NCT00793624|EG001|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10947302|NCT00793624|EG002|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10947303|NCT00793624|EG003|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10947304|NCT00793650|BG000|Baseline|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947305|NCT00793650|BG001|Baseline|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947306|NCT00793650|BG002|Baseline|Total|Total of all reporting groups
10947307|NCT00793650|FG000|Participant Flow|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947308|NCT00793650|FG001|Participant Flow|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947309|NCT00793650|OG000|Outcome|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947310|NCT00793650|OG001|Outcome|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947311|NCT00793650|OG000|Outcome|Bortezomib Before Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947312|NCT00793650|OG001|Outcome|Bortezomib After Melphalan|"patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947313|NCT00793650|EG000|Reported Event|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947314|NCT00793650|EG001|Reported Event|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
10947315|NCT00793780|BG000|Baseline|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
10947316|NCT00793780|BG001|Baseline|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
11177810|NCT02043899|OG000|Outcome|Single Arm Trial|[124I]meta-Iodobenzylguanidine: Single intravenous administration of [124I]mIBG Solution for Injection on Day 1 with a maximum radioactive dose of 1.42 MBq/kg (±10%) and a maximum injected dose of 50 MBq [124I]mIBG equating to a maximum chemical dose of 10 micrograms of stable mIBG. The activity to paediatric patients will be scaled by weight based upon the EANM paediatric dose card (Lassmann et al., 2007). This will result in an activity between 10 MBq and 50 MBq depending on the patient's weight.
10947317|NCT00793780|BG002|Baseline|Total|Total of all reporting groups
10947318|NCT00793780|FG000|Participant Flow|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
10947319|NCT00793780|FG001|Participant Flow|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
11240745|NCT02481505|OG001|Outcome|4 mL Chloroprocaine HCl 1%|"Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947320|NCT00793780|OG000|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
10947321|NCT00793780|OG001|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
10947322|NCT00793780|EG000|Reported Event|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
10947323|NCT00793780|EG001|Reported Event|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
10947324|NCT00793793|BG000|Baseline|Treatment Naive (TN): Placebo|TN patient to receive Placebo + PegIFN/RBV for 28 days
10947325|NCT00793793|BG001|Baseline|TN: 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947326|NCT00793793|BG002|Baseline|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947327|NCT00793793|BG003|Baseline|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947328|NCT00793793|BG004|Baseline|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947329|NCT00793793|BG005|Baseline|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947330|NCT00793793|BG006|Baseline|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947331|NCT00793793|BG007|Baseline|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947332|NCT00793793|BG008|Baseline|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947333|NCT00793793|BG009|Baseline|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947334|NCT00793793|BG010|Baseline|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947335|NCT00793793|BG011|Baseline|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947336|NCT00793793|BG012|Baseline|Total|Total of all reporting groups
10947337|NCT00793793|FG000|Participant Flow|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
10947338|NCT00793793|FG001|Participant Flow|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
10947339|NCT00793793|FG002|Participant Flow|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947340|NCT00793793|FG003|Participant Flow|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947341|NCT00793793|FG004|Participant Flow|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947342|NCT00793793|FG005|Participant Flow|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947343|NCT00793793|FG006|Participant Flow|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947344|NCT00793793|FG007|Participant Flow|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947345|NCT00793793|FG008|Participant Flow|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947346|NCT00793793|FG009|Participant Flow|TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947347|NCT00793793|FG010|Participant Flow|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947348|NCT00793793|FG011|Participant Flow|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947349|NCT00793793|OG000|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
10947350|NCT00793793|OG001|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947351|NCT00793793|OG002|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947352|NCT00793793|OG003|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947353|NCT00793793|OG004|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947354|NCT00793793|OG005|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947355|NCT00793793|OG006|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
11177811|NCT02043899|EG000|Reported Event|Single Arm Trial|[124I]meta-Iodobenzylguanidine: Single intravenous administration of [124I]mIBG Solution for Injection on Day 1 with a maximum radioactive dose of 1.42 MBq/kg (±10%) and a maximum injected dose of 50 MBq [124I]mIBG equating to a maximum chemical dose of 10 micrograms of stable mIBG. The activity to paediatric patients will be scaled by weight based upon the EANM paediatric dose card (Lassmann et al., 2007). This will result in an activity between 10 MBq and 50 MBq depending on the patient's weight.
11177812|NCT02043938|BG000|Baseline|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
11341728|NCT03687684|OG001|Outcome|Japanese Cohort 1: TAK-831 100 mg|TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
10947356|NCT00793793|OG007|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947357|NCT00793793|OG008|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947358|NCT00793793|OG009|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947359|NCT00793793|OG010|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947360|NCT00793793|OG011|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947361|NCT00793793|OG005|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947362|NCT00793793|OG000|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
10947363|NCT00793793|OG001|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
10947364|NCT00793793|OG000|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
10947365|NCT00793793|OG001|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
10947366|NCT00793793|OG008|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947367|NCT00793793|OG009|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947368|NCT00793793|OG000|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
10947369|NCT00793793|OG005|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE patient non-cirrhotic to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947370|NCT00793793|OG000|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947371|NCT00793793|OG001|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947372|NCT00793793|OG002|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947373|NCT00793793|OG003|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947374|NCT00793793|OG004|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947375|NCT00793793|OG005|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947376|NCT00793793|OG006|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947377|NCT00793793|OG007|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947378|NCT00793793|OG009|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947379|NCT00793793|OG010|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947380|NCT00793793|OG000|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
10947381|NCT00793793|EG000|Reported Event|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
10947382|NCT00793793|EG001|Reported Event|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
10947383|NCT00793793|EG002|Reported Event|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947384|NCT00793793|EG003|Reported Event|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947385|NCT00793793|EG004|Reported Event|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
10947386|NCT00793793|EG005|Reported Event|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947387|NCT00793793|EG006|Reported Event|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947388|NCT00793793|EG007|Reported Event|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
10947389|NCT00793793|EG008|Reported Event|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947390|NCT00793793|EG009|Reported Event|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
11177813|NCT02043938|FG000|Participant Flow|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
11240746|NCT02481505|OG002|Outcome|5 mL Chloroprocaine HCl 1%|"Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947391|NCT00793793|EG010|Reported Event|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947392|NCT00793793|EG011|Reported Event|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
10947393|NCT00793819|BG000|Baseline|Silodosin 8mg|Silodosin 8mg daily
10947394|NCT00793819|BG001|Baseline|Placebo|1 placebo capsule daily
10947395|NCT00793819|BG002|Baseline|Total|Total of all reporting groups
10947396|NCT00793819|FG000|Participant Flow|Silodosin 8mg|Silodosin 8mg daily
10947397|NCT00793819|FG001|Participant Flow|Placebo|1 placebo capsule daily
10947398|NCT00793819|OG000|Outcome|Silodosin 8mg|Silodosin 8mg daily
10947399|NCT00793819|OG001|Outcome|Placebo|1 placebo capsule daily
10947400|NCT00793819|EG000|Reported Event|Silodosin 8mg|Silodosin 8mg daily
10947401|NCT00793819|EG001|Reported Event|Placebo|1 placebo capsule daily
10947402|NCT00793871|BG000|Baseline|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
10947403|NCT00793871|FG000|Participant Flow|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
10947404|NCT00793871|OG000|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
10947405|NCT00793871|EG000|Reported Event|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
10947406|NCT00793910|BG000|Baseline|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
10947407|NCT00793910|BG001|Baseline|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
10947408|NCT00793910|BG002|Baseline|Total|Total of all reporting groups
10947409|NCT00793910|FG000|Participant Flow|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
10947410|NCT00793910|FG001|Participant Flow|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
10947411|NCT00793910|OG000|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
10947412|NCT00793910|OG001|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
10947413|NCT00793910|EG000|Reported Event|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
10947414|NCT00793910|EG001|Reported Event|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
10947415|NCT00794040|BG000|Baseline|Add-on Citalopram Following Optimized Methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
10947416|NCT00794040|BG001|Baseline|Add-on Placebo Following Optimized Methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
10947417|NCT00794040|BG002|Baseline|Total|Total of all reporting groups
10947418|NCT00794040|FG000|Participant Flow|Add-on Citalopram Following Optimized Methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
11177814|NCT02043938|OG000|Outcome|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
11177815|NCT02043938|EG000|Reported Event|Healthy Volunteers, Propofol (P)|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
11177816|NCT02043938|EG001|Reported Event|Healthy Volunteers, Sevoflurane (S)|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
11177817|NCT02043938|EG002|Reported Event|Healthy Volunteers, Propofol With Remifentanil (PR)|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
11177818|NCT02043938|EG003|Reported Event|Healthy Volunteers, Sevoflurane With Remifentanil (SR)|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
11177819|NCT02044094|BG000|Baseline|Depot Buprenorphine|Participants were treated with RBP-6000 300-mg in a single subcutaneous injection on Days 1 and 29. Challenges consist of participants receiving on three consecutive days intramuscular (IM) injections of hydromorphone randomly assigned at 0 mg (placebo), 6 mg and 18 mg doses during weeks 1-12.
11177820|NCT02044094|FG000|Participant Flow|Depot Buprenorphine|Participants were treated with RBP-6000 300-mg in a single subcutaneous injection on Days 1 and 29. Challenges consist of participants receiving on three consecutive days intramuscular (IM) injections of hydromorphone randomly assigned at 0 mg (placebo), 6 mg and 18 mg doses during weeks 1-12.
11177821|NCT02044094|OG000|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
11177822|NCT02044094|OG001|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
11177823|NCT02044094|OG002|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
11177824|NCT02044094|OG000|Outcome|Depot Buprenorphine|Participants were treated with RBP-6000 300-mg in a single subcutaneous injection on Days 1 and 29.
11341729|NCT03687684|OG002|Outcome|Japanese Cohort 1: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
10947419|NCT00794040|FG001|Participant Flow|Add-on Placebo Following Optimized Methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
10947420|NCT00794040|OG000|Outcome|Add-on Citalopram Following Optimized Methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
10947421|NCT00794040|OG001|Outcome|Add-on Placebo Following Optimized Methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
10947422|NCT00794040|EG000|Reported Event|Add-on Citalopram Following Optimized Methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
10947423|NCT00794040|EG001|Reported Event|Add-on Placebo Following Optimized Methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
10947424|NCT00794118|BG000|Baseline|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months.
10947425|NCT00794118|FG000|Participant Flow|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months.
10947426|NCT00794118|OG000|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months.
10947427|NCT00794118|EG000|Reported Event|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months.
10947428|NCT00794144|BG000|Baseline|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
10947429|NCT00794144|BG001|Baseline|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
10947430|NCT00794144|BG002|Baseline|Total|Total of all reporting groups
10947431|NCT00794144|FG000|Participant Flow|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
10947432|NCT00794144|FG001|Participant Flow|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
10947433|NCT00794144|OG000|Outcome|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
10947434|NCT00794144|OG001|Outcome|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
10947435|NCT00794144|EG000|Reported Event|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
10947436|NCT00794144|EG001|Reported Event|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
10947437|NCT00794157|BG000|Baseline|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947438|NCT00794157|BG001|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947439|NCT00794157|BG002|Baseline|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947440|NCT00794157|BG003|Baseline|Total|Total of all reporting groups
11177825|NCT02044094|OG001|Outcome|Placebo Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The placebo challenge consisted of an intramuscular injection of placebo (hydromorphone 0mg)."
11177826|NCT02044094|OG002|Outcome|Hydromorphone 6 mg Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The hydromorphone 6 mg challenge consisted of an intramuscular injection of 6 mg hydromorphone."
10947441|NCT00794157|FG000|Participant Flow|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947442|NCT00794157|FG001|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947443|NCT00794157|FG002|Participant Flow|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947444|NCT00794157|OG000|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947445|NCT00794157|OG001|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947446|NCT00794157|OG002|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947447|NCT00794157|EG000|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947448|NCT00794157|EG001|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947449|NCT00794157|EG002|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10947450|NCT00794170|BG000|Baseline|Telephone and Print Based Intervention|This was a tailored phone call followed up by print materials.
10947451|NCT00794170|BG001|Baseline|Usual Care|control
10947452|NCT00794170|BG002|Baseline|Total|Total of all reporting groups
11177827|NCT02044094|OG003|Outcome|Hydromorphone 18 mg Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The hydromorphone 18 mg challenge consisted of an intramuscular injection of 18 mg hydromorphone."
11177828|NCT02044094|OG000|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
10947453|NCT00794170|FG000|Participant Flow|Telephone and Print Based Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
10947454|NCT00794170|FG001|Participant Flow|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection.
10947455|NCT00794170|OG000|Outcome|Telephone and Print Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
10947456|NCT00794170|OG001|Outcome|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection. Both groups receive birthday cards from the study team.
10947457|NCT00794170|EG000|Reported Event|Telephone and Print Based Intervention|
10947458|NCT00794170|EG001|Reported Event|Usual Care|
10947459|NCT00794196|BG000|Baseline|Usual Care|The control group will be receiving usual medical and pharmaceutical care.
10947460|NCT00794196|BG001|Baseline|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
10947461|NCT00794196|BG002|Baseline|Total|Total of all reporting groups
10947462|NCT00794196|FG000|Participant Flow|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
10947463|NCT00794196|FG001|Participant Flow|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
10947464|NCT00794196|OG000|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
10947465|NCT00794196|OG001|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
10947466|NCT00794196|EG000|Reported Event|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
10947467|NCT00794196|EG001|Reported Event|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
10947468|NCT00794313|BG000|Baseline|All Study Participants|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks or Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week or Sugar Pill : sugar pill, capsule, three times a day, 2 weeks"
10947469|NCT00794313|FG000|Participant Flow|Amantadine, Then Amantadine + Topiramate, Then Placebo|Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks
10947470|NCT00794313|FG001|Participant Flow|Amantadine + Topiramate, Then Placebo, Then Amantadine|Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2)
10947471|NCT00794313|FG002|Participant Flow|Placebo, Then Amantadine, Then Amantadine + Topiramate|Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2)
10947472|NCT00794313|OG000|Outcome|Amantadine|Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
11177829|NCT02044094|OG001|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
10947473|NCT00794313|OG001|Outcome|Amantadine Plus Topiramate|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
10947474|NCT00794313|OG002|Outcome|Sugar Pill|Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
10947475|NCT00794313|OG000|Outcome|Amantadine|Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks
10947476|NCT00794313|OG001|Outcome|Amantadine Plus Topiramate|"Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate: Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
10947477|NCT00794313|OG002|Outcome|Sugar Pill|Sugar Pill: sugar pill, capsule, three times a day, 2 weeks
10947478|NCT00794313|EG000|Reported Event|Amantadine|Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
10947479|NCT00794313|EG001|Reported Event|Amantadine Plus Topiramate|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
10947480|NCT00794313|EG002|Reported Event|Sugar Pill|Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
10947481|NCT00794339|BG000|Baseline|Copper ATSM|"pre-therapy pelvic 64Cu-ATSM-PET/CT with Pre- and post- therapy FDG PET/CT~64Cu-ATSM~FDG"
10947482|NCT00794339|FG000|Participant Flow|Copper ATSM|pre-therapy pelvic [64Cu][Cu-diacetyl-bis(N(4)-methylthiosemicarbazone)] (64Cu-ATSM) PET/CT exam with Pre- and post- therapy (18)F-fluorodeoxyglucose (FDG) PET/CT exams
10947483|NCT00794339|OG000|Outcome|64 CU-ATSM SUVmax @ Baseline|The maximum standardized uptake value (SUVmax) is the Cu64-ATSM Uptake measured within 14 days of baseline is defined as SUVmax = tracer uptake in ROI / (injected activity / patient weight))
10947484|NCT00794339|OG001|Outcome|64 CU-ATSM T/M Ratio @ Baseline|"Cu64-ATSM uptake measured using the Tumor-to-Muscle uptake ratio within 14 days of baseline The tumor uptake is measured by selecting an FDG-PET/CT-guided circular region of interest of 1.0-1.5 cm in diameter around the most intense region of the primary tumor to calculate the maximum uptake within the region.~The Muscle uptake is measured by selecting regions of interest on bilateral gluteal muscle groups on at least 3 slices, and calculating the mean uptake.~The T/M uptake is the ratio of these 2 measurements."
10947485|NCT00794339|OG000|Outcome|T/M Below Median|Tumor-to-muscle ratio (T/M) below the observed median value of 7.3
10947486|NCT00794339|OG001|Outcome|T/M at or Above Median|Tumor-to-muscle ratio (T/M) at or above the observed median value of 7.3
10947487|NCT00794339|OG000|Outcome|Eligible Participants|All eligible participants with evaluable pre-therapy pelvic 64Cu-ATSM-PET/CT within 14 days of baseline and with Pre- and post- therapy FDG PET/CT
10947488|NCT00794339|OG000|Outcome|0=<1% Tumor Cells|T/M ratio for subjects with Hypoxia categorized as 0=<1% tumor cells using the Percentage of Tumor Cells Staining Score.
11177830|NCT02044094|EG000|Reported Event|Depot Buprenorphine|Participants were treated with RBP-6000 300 mg in a single subcutaneous injection on Days 1 and 29.
10947489|NCT00794339|OG001|Outcome|1-33% Tumor Cells|T/M ratio for subjects with Hypoxia categorized as 1-33% tumor cells using the Percentage of Tumor Cells Staining Score.
10947490|NCT00794339|OG002|Outcome|34-66% Tumor Cells|T/M ratio for subjects with Hypoxia categorized as 34-66% tumor cells using the Percentage of Tumor Cells Staining Score.
10947491|NCT00794339|OG003|Outcome|>66% Tumor Cells|T/M ratio for subjects with Hypoxia categorized as >66% tumor cells using the Percentage of Tumor Cells Staining Score.
10947492|NCT00794339|OG000|Outcome|No Staining|"T/M ratio for subjects with Hypoxia categorized as No staining using the Staining Intensity Score"
10947493|NCT00794339|OG001|Outcome|Weak Staining|"T/M ratio for subjects with Hypoxia categorized as Weak staining using the Staining Intensity Score"
10947494|NCT00794339|OG002|Outcome|Moderate to Strong Staining|"T/M ratio for subjects with Hypoxia categorized as Moderate to strong staining using the Staining Intensity Score"
10947495|NCT00794339|OG000|Outcome|Composite Score: 0|T/M ratio for subjects with Hypoxia composite score of 0
10947496|NCT00794339|OG001|Outcome|Composite Score: 1|T/M ratio for subjects with Hypoxia composite score of 1
10947497|NCT00794339|OG002|Outcome|Composite Score: 2|T/M ratio for subjects with Hypoxia composite score of 2
10947498|NCT00794339|OG003|Outcome|Composite Score: 3|T/M ratio for subjects with Hypoxia composite score of 3
10947499|NCT00794339|OG004|Outcome|Composite Score: 4|T/M ratio for subjects with Hypoxia composite score of 4
10947500|NCT00794339|OG005|Outcome|Composite Score: 6|T/M ratio for subjects with Hypoxia composite score of 6
10947501|NCT00794339|EG000|Reported Event|Copper ATSM|pre-therapy pelvic 64Cu-ATSM-PET/CT with Pre- and post- therapy FDG PET/CT
10947502|NCT00794365|BG000|Baseline|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
10947503|NCT00794365|FG000|Participant Flow|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
10947504|NCT00794365|OG000|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
10947505|NCT00794365|EG000|Reported Event|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
10947506|NCT00794417|BG000|Baseline|Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
11240747|NCT02481505|EG000|Reported Event|3 mL Chloroprocaine HCl 1%|"Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947507|NCT00794417|BG001|Baseline|Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947508|NCT00794417|BG002|Baseline|Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947509|NCT00794417|BG003|Baseline|Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.
10947510|NCT00794417|BG004|Baseline|Total|Total of all reporting groups
10947511|NCT00794417|FG000|Participant Flow|Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947512|NCT00794417|FG001|Participant Flow|Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947513|NCT00794417|FG002|Participant Flow|Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947514|NCT00794417|FG003|Participant Flow|Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.
10947515|NCT00794417|OG000|Outcome|Phase 1: All Participants|All participants who received intravenous infusion of aflibercept 2 mg/kg or 4 mg/kg or 6 mg/kg followed by pemetrexed 500 mg/square metere (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
11177831|NCT02044094|EG001|Reported Event|Placebo Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The placebo challenge consisted of an intramuscular injection of placebo (hydromorphone 0mg)."
10947516|NCT00794417|OG000|Outcome|Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.
10947517|NCT00794417|OG000|Outcome|Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947518|NCT00794417|OG001|Outcome|Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947519|NCT00794417|OG002|Outcome|Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947520|NCT00794417|OG003|Outcome|Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.
10947521|NCT00794417|EG000|Reported Event|Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947522|NCT00794417|EG001|Reported Event|Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947523|NCT00794417|EG002|Reported Event|Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
10947524|NCT00794417|EG003|Reported Event|Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin|Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.
11240748|NCT02481505|EG001|Reported Event|4 mL Chloroprocaine HCl 1%|"Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
10947525|NCT00794469|BG000|Baseline|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
10947526|NCT00794469|FG000|Participant Flow|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
10947527|NCT00794469|OG000|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
10947528|NCT00794469|EG000|Reported Event|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
10947529|NCT00794508|BG000|Baseline|Experimental Retroviral-mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
10947530|NCT00794508|FG000|Participant Flow|Gamma-retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.~ADA gene transfer: Autologous CD34+ cells transduced with the gamma-retroviral vector, MND-ADA, carrying the human ADA gene."
10947531|NCT00794508|OG000|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
10947532|NCT00794508|EG000|Reported Event|Retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.~ADA gene transfer: Autologous CD34+ cells transduced with the retroviral vector MND-ADA, carrying the human ADA gene."
10947533|NCT00794547|BG000|Baseline|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
10947534|NCT00794547|FG000|Participant Flow|Phase 1|"In the Phase I part of the study, we will test the safety of calcitriol along with standard chemotherapy. In addition, the goal is to see what effects (good and bad) it has on you and your type of Non-Small Cell Lung Cancer. This study is ongoing. In this portion of the study, we are testing increasing doses of calcitriol in combination with standard chemotherapy. If 2/3 patients at any dose level experience side effects that are limiting, we will call the dose level below that dose the maximum tolerated dose.~Calcitriol: Escalating dose of Calcitriol will be infused IV over 1 hour every 21 days."
10947535|NCT00794547|FG001|Participant Flow|Phase 2|"In the Phase II part of the study, we will find out the response of subjects' cancer has to the combination of a fixed dose of calcitriol (determined in the phase I study) with standard chemotherapy.~Calcitriol: In this portion of the study, all patients will get the same dose of calcitriol (determined from the Phase I study) along with the standard chemotherapy"
10947536|NCT00794547|OG000|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
10947537|NCT00794547|EG000|Reported Event|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
10947538|NCT00794560|BG000|Baseline|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
10947539|NCT00794560|BG001|Baseline|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
10947540|NCT00794560|BG002|Baseline|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
10947541|NCT00794560|BG003|Baseline|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
10947542|NCT00794560|BG004|Baseline|Total|Total of all reporting groups
10947543|NCT00794560|FG000|Participant Flow|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
11177832|NCT02044094|EG002|Reported Event|Hydromorphone 6 mg Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The hydromorphone 6 mg challenge consisted of an intramuscular injection of 6 mg hydromorphone."
10947544|NCT00794560|FG001|Participant Flow|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
11177833|NCT02044094|EG003|Reported Event|Hydromorphone 18 mg Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The hydromorphone 18 mg challenge consisted of an intramuscular injection of 18 mg hydromorphone."
10947545|NCT00794560|FG002|Participant Flow|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
10947546|NCT00794560|FG003|Participant Flow|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
10947547|NCT00794560|OG000|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
10947548|NCT00794560|OG001|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
10947549|NCT00794560|OG002|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
10947550|NCT00794560|OG003|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
10947551|NCT00794560|EG000|Reported Event|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
10947552|NCT00794560|EG001|Reported Event|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
10947553|NCT00794560|EG002|Reported Event|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
10947554|NCT00794560|EG003|Reported Event|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
10947555|NCT00794573|BG000|Baseline|Varenicline|0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
10947556|NCT00794573|BG001|Baseline|Placebo|placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
10947557|NCT00794573|BG002|Baseline|Total|Total of all reporting groups
10947558|NCT00794573|FG000|Participant Flow|Varenicline|0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
10947559|NCT00794573|FG001|Participant Flow|Placebo|placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
10947560|NCT00794573|OG000|Outcome|Varenicline|0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
10947561|NCT00794573|OG001|Outcome|Placebo|placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
10947562|NCT00794573|EG000|Reported Event|Varenicline|0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
10947563|NCT00794573|EG001|Reported Event|Placebo|placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
10947564|NCT00794664|BG000|Baseline|Placebo|Weekly subcutaneous injections for 26 weeks
10947565|NCT00794664|BG001|Baseline|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
10947566|NCT00794664|BG002|Baseline|Total|Total of all reporting groups
11240749|NCT02481505|EG002|Reported Event|5 mL Chloroprocaine HCl 1%|"Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)~Chloroprocaine HCl 1%: Intrathecal Route"
11240750|NCT02481557|BG000|Baseline|Oxalate Salt Solution|"Professionally applied~Oxalate Salt Solution: Applied by dentist"
10947567|NCT00794664|FG000|Participant Flow|Placebo|Weekly subcutaneous injections for 26 weeks
10947568|NCT00794664|FG001|Participant Flow|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
10947569|NCT00794664|OG000|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
10947570|NCT00794664|OG001|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
10947571|NCT00794664|EG000|Reported Event|Placebo|Weekly subcutaneous injections for 26 weeks
10947572|NCT00794664|EG001|Reported Event|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
10947573|NCT00794820|BG000|Baseline|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
10947574|NCT00794820|FG000|Participant Flow|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
10947575|NCT00794820|OG000|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
10947576|NCT00794820|EG000|Reported Event|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
10947577|NCT00794950|BG000|Baseline|Sunitinib Treatment|"Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.~Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.~Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG."
10947578|NCT00794950|FG000|Participant Flow|Sunitinib Treatment|"Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.~Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.~Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG."
10947579|NCT00794950|OG000|Outcome|Sunitinib Treatment|"Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.~Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib. Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG."
10947580|NCT00794950|OG000|Outcome|Sunitinib Treatment|"Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.~Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.~Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG."
10947581|NCT00794950|EG000|Reported Event|Sunitinib Treatment|"Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.~Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.~Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a 2 week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a 2nd course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG."
10947582|NCT00794963|BG000|Baseline|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
11240751|NCT02481557|BG001|Baseline|No Treatment|No Treatment
11240752|NCT02481557|BG002|Baseline|Total|Total of all reporting groups
10947583|NCT00794963|BG001|Baseline|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
10947584|NCT00794963|BG002|Baseline|Total|Total of all reporting groups
10947585|NCT00794963|FG000|Participant Flow|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
10947586|NCT00794963|FG001|Participant Flow|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
10947587|NCT00794963|OG000|Outcome|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
10947588|NCT00794963|OG001|Outcome|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
10947589|NCT00794963|EG000|Reported Event|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
10947590|NCT00794963|EG001|Reported Event|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
10947591|NCT00795002|BG000|Baseline|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
10947592|NCT00795002|BG001|Baseline|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
10947593|NCT00795002|BG002|Baseline|Total|Total of all reporting groups
11192200|NCT02137772|OG000|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
11240753|NCT02481557|FG000|Participant Flow|Oxalate Salt Solution|"Professionally applied~Oxalate Salt Solution: Applied by dentist"
11240754|NCT02481557|FG001|Participant Flow|No Treatment|No study treatment
11240755|NCT02481557|OG000|Outcome|Oxalate Salt Solution|"Professionally applied~Oxalate Salt Solution: Applied by dentist"
10947594|NCT00795002|FG000|Participant Flow|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
10947595|NCT00795002|FG001|Participant Flow|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
10947596|NCT00795002|OG000|Outcome|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
10947597|NCT00795002|OG001|Outcome|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
10947598|NCT00795002|EG000|Reported Event|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
10947599|NCT00795002|EG001|Reported Event|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
10947600|NCT00795132|BG000|Baseline|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
10947601|NCT00795132|FG000|Participant Flow|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
10947602|NCT00795132|OG000|Outcome|Related BM PBSC|Related donor: bone marrow or peripheral blood stem cell (PBSC)
10947603|NCT00795132|OG001|Outcome|Unrelated BM PBSC|Unrelated donor: bone marrow or peripheral blood stem cell (PBSC)
10947604|NCT00795132|OG002|Outcome|Unrelated Cord Blood|Unrelated donor: Cord Blood
10947605|NCT00795132|OG000|Outcome|Related BM PBSC|All participants were analyzed.
10947606|NCT00795132|OG001|Outcome|Unrelated BM PBSC|All participants were analyzed.
10947607|NCT00795132|OG002|Outcome|Unrelated Cord Blood|All participants were analyzed.
10947608|NCT00795132|OG000|Outcome|Related BM PBSC|All incidences of enrolled patients were analyzed.
10947609|NCT00795132|OG001|Outcome|Unrelated BM PBSC|All incidences of enrolled patients were analyzed.
10947610|NCT00795132|OG002|Outcome|Unrelated Cord Blood|All incidences of enrolled patients were analyzed.
10947611|NCT00795132|EG000|Reported Event|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
10947612|NCT00795145|BG000|Baseline|Cohort 1: Placebo, Linezolid 900 mg and 1200 mg|Subjects were randomly assigned to placebo followed by linezolid 900 mg then 1200 mg linezolid in Sequence 1; or, linezolid 900 mg then linezolid 1200 mg followed by placebo in Sequence 2; or, linezolid 900 mg then placebo followed by linezolid 1200 mg in Sequence 3. There was a washout period of 48 hours between doses.
10947613|NCT00795145|BG001|Baseline|Cohort 2: Placebo, Linezolid 600 mg and 1200 mg, Moxifloxacin|Subjects were randomly assigned to placebo first then moxifloxacin followed by linezolid 600 mg and 1200 mg linezolid last in Sequence 1; or linezolid 600 mg first then linezolid 1200 mg followed by placebo and moxifloxacin last in Sequence 2; or, linezolid 1200 mg first then moxifloxacin 400 mg followed by linezolid 600 mg and placebo last in Sequence 3; or, moxifloxacin 400 mg first then placebo followed by linezolid 1200 mg and 600 mg linezolid last in Sequence 4. There was a washout period of 48 hours between each dose.
10947614|NCT00795145|BG002|Baseline|Total|Total of all reporting groups
10947615|NCT00795145|FG000|Participant Flow|Cohort 1: Sequence 1|Subjects were randomly assigned to placebo first, then linezolid 900 milligrams (mg) followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 1.
10947616|NCT00795145|FG001|Participant Flow|Cohort 1: Sequence 2|Subjects were randomly assigned to linezolid 900 mg first, then placebo, followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 2.
10947617|NCT00795145|FG002|Participant Flow|Cohort 1: Sequence 3|Subjects were randomly assigned to linezolid 900 mg first, then 1200 mg linezolid, followed by placebo after a washout period of 48 hours between doses in Sequence 3.
10947618|NCT00795145|FG003|Participant Flow|Cohort 2: Sequence 1|Subjects were randomly assigned to placebo, then moxifloxacin, followed by linezolid 600 mg and 1200 mg, after a washout period of 48 hours between doses in Sequence 1.
10947619|NCT00795145|FG004|Participant Flow|Cohort 2: Sequence 2|Subjects were randomly assigned to linezolid 600 mg first, then linezolid 1200 mg followed by placebo and moxifloxacin, after a washout period of 48 hours between doses in Sequence 2.
10947620|NCT00795145|FG005|Participant Flow|Cohort 2: Sequence 3|Subjects were randomly assigned to linezolid 1200 mg first, then moxifloxacin 400 mg followed by linezolid 600 mg and placebo after a washout period of 48 hours between doses in Sequence 3.
10947621|NCT00795145|FG006|Participant Flow|Cohort 2: Sequence 4|Subjects were randomly assigned to moxifloxacin 400 mg first, then placebo followed by linezolid 1200 mg and 600 mg linezolid after a washout period of 48 hours between doses in Sequence 4.
10947622|NCT00795145|OG000|Outcome|Cohort 1: Placebo|600 milliliters (mL) saline as a constant rate intravenous (IV) infusion of 60 minutes.
10947623|NCT00795145|OG001|Outcome|Cohort 1: 900 mg Linezolid|450 mL Zyvox plus 150 mL saline as a constant rate IV infusion of 60 minutes.
10947624|NCT00795145|OG002|Outcome|Cohort 1: 1200 mg Linezolid|600 mL Zyvox as a constant rate IV infusion of 60 minutes.
10947625|NCT00795145|OG000|Outcome|Cohort 1: 900 mg Linezolid|
11192201|NCT02137772|OG001|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
10947626|NCT00795145|OG001|Outcome|Cohort 1: 1200 mg Linezolid|
10947627|NCT00795145|OG000|Outcome|Cohort 2: 600 mg Linezolid|Zyvox IV Injection
11240756|NCT02481557|OG001|Outcome|No Treatment|No Treatment
10947628|NCT00795145|OG001|Outcome|Cohort 2: 1200 mg Linezolid|Zyvox IV Injection
10947629|NCT00795145|OG002|Outcome|Cohort 2: Placebo|0.9% Saline
10947630|NCT00795145|OG000|Outcome|Cohort 2: Moxifloxacin|Oral administration, positive control, not blinded.
11240757|NCT02481557|EG000|Reported Event|Oxalate Salt Solution|"Professionally applied~Oxalate Salt Solution: Applied by dentist"
11240758|NCT02481557|EG001|Reported Event|No Treatment|No Treatment
10947631|NCT00795145|OG001|Outcome|Cohort 2: Placebo|
10947632|NCT00795145|OG000|Outcome|Cohort 2: Placebo|
10947633|NCT00795145|OG001|Outcome|Cohort 2: 600 mg Linezolid|
10947634|NCT00795145|OG002|Outcome|Cohort 2: 1200 mg Linezolid|
10947635|NCT00795145|OG000|Outcome|Cohort 2: 900 mg Linezolid|
10947636|NCT00795145|OG001|Outcome|Cohort 2: 1200 mg Linezolid|
10947637|NCT00795145|OG000|Outcome|Cohort 2: 600 mg Linezolid|
10947638|NCT00795145|OG002|Outcome|Cohort 2: Placebo|
10947639|NCT00795145|OG003|Outcome|Moxifloxacin 400 mg|
10947640|NCT00795145|EG000|Reported Event|Cohort 1: Placebo|
10947641|NCT00795145|EG001|Reported Event|Cohort 1: 900 mg Linezolid|
10947642|NCT00795145|EG002|Reported Event|Cohort 1: 1200 mg Linezolid|
10947643|NCT00795145|EG003|Reported Event|Cohort 2: Placebo|
10947644|NCT00795145|EG004|Reported Event|Cohort 2: 600 mg Linezolid|
10947645|NCT00795145|EG005|Reported Event|Cohort 2: 1200 mg Linezolid|
10947646|NCT00795145|EG006|Reported Event|Cohort 2: 400 mg Moxifloxacin|
10947647|NCT00795184|BG000|Baseline|Group 1|NBI-pCLE
10947648|NCT00795184|FG000|Participant Flow|HDWLE First NBI Second and pCLE|
10947649|NCT00795184|FG001|Participant Flow|NBI First HDWLE Second and pCLE|
10947650|NCT00795184|OG000|Outcome|HDWLE|
10947651|NCT00795184|OG001|Outcome|NBI (Narrow Band Imaging)|
10947652|NCT00795184|OG002|Outcome|pCLE|
10947653|NCT00795184|OG003|Outcome|HDWLE+NBI+pCLE|
10947654|NCT00795184|OG004|Outcome|HDWLE+pCLE|
10947655|NCT00795184|OG005|Outcome|HDWLE+NBI|
10947656|NCT00795184|EG000|Reported Event|Group 1|NBI-pCLE or pCLE-NBI
10947657|NCT00795210|BG000|Baseline|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
10947658|NCT00795210|BG001|Baseline|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
10947659|NCT00795210|BG002|Baseline|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
10947660|NCT00795210|BG003|Baseline|Total|Total of all reporting groups
10947661|NCT00795210|FG000|Participant Flow|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
10947662|NCT00795210|FG001|Participant Flow|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
10947663|NCT00795210|FG002|Participant Flow|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
10947664|NCT00795210|OG000|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
10947665|NCT00795210|OG001|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
10947666|NCT00795210|OG002|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
10947667|NCT00795210|EG000|Reported Event|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
10947668|NCT00795210|EG001|Reported Event|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
10947669|NCT00795210|EG002|Reported Event|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
10947670|NCT00795275|BG000|Baseline|People With Impaired Fasting Glucose|"people with impaired fasting glucose~Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947671|NCT00795275|BG001|Baseline|People With Normal Glucose Tolerance|"people with normal glucose tolerance~Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947672|NCT00795275|BG002|Baseline|Total|Total of all reporting groups
10947673|NCT00795275|FG000|Participant Flow|People With Impaired Fasting Glucose|"people with impaired fasting glucose~Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947674|NCT00795275|FG001|Participant Flow|People With Normal Glucose Tolerance|"people with normal glucose tolerance~Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947675|NCT00795275|OG000|Outcome|People With Impaired Fasting Glucose|"people with impaired fasting glucose~Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947676|NCT00795275|OG001|Outcome|People With Normal Glucose Tolerance|"people with normal glucose tolerance~Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947677|NCT00795275|OG000|Outcome|Impaired Fasting Glucose|"Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate)~Sitagliptin Phosphate: Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947678|NCT00795275|OG001|Outcome|Normal Glucose Tolerance|"Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate)~Sitagliptin Phosphate: Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947679|NCT00795275|EG000|Reported Event|People With Impaired Fasting Glucose|"people with impaired fasting glucose~Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947680|NCT00795275|EG001|Reported Event|People With Normal Glucose Tolerance|"people with normal glucose tolerance~Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made"
10947681|NCT00795288|BG000|Baseline|Simvastatin|"Simvastatin, 80 mg/day~Simvastatin, 80 mg/day for 21 days: Active treatment group"
10947682|NCT00795288|BG001|Baseline|Control|placebo: Control group
10947683|NCT00795288|BG002|Baseline|Total|Total of all reporting groups
10947684|NCT00795288|FG000|Participant Flow|Placebo|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
10947685|NCT00795288|FG001|Participant Flow|Simvastatin|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
10947686|NCT00795288|OG000|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
11341730|NCT03687684|OG003|Outcome|Japanese Cohort 2, 4 and 5: Pooled Placebo|TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10947687|NCT00795288|OG001|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
10947688|NCT00795288|OG000|Outcome|Simvastatin, 80 mg/Day|"Simvastatin, 80 mg/day for 21 days~Simvastatin, 80 mg/day for 21 days: Active treatment group"
10947689|NCT00795288|OG001|Outcome|Placebo|"Placebo~placebo: Control group"
10947690|NCT00795288|EG000|Reported Event|Simvastatin|"Simvastatin, 80 mg/day~Simvastatin, 80 mg/day for 21 days: Active treatment group"
10947691|NCT00795288|EG001|Reported Event|Control|placebo: Control group
10947692|NCT00795340|BG000|Baseline|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
10947693|NCT00795340|BG001|Baseline|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
10947694|NCT00795340|BG002|Baseline|Total|Total of all reporting groups
10947695|NCT00795340|FG000|Participant Flow|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
10947696|NCT00795340|FG001|Participant Flow|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
10947697|NCT00795340|OG000|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
10947698|NCT00795340|OG001|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
10947699|NCT00795340|EG000|Reported Event|Cediranib|Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
10947700|NCT00795340|EG001|Reported Event|Placebo|Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
10947701|NCT00795366|BG000|Baseline|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
10947702|NCT00795366|BG001|Baseline|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
10947703|NCT00795366|BG002|Baseline|Total|Total of all reporting groups
10947704|NCT00795366|FG000|Participant Flow|AVP, Arginine Vasopressin|Vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
10947705|NCT00795366|FG001|Participant Flow|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
10947706|NCT00795366|OG000|Outcome|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
10947707|NCT00795366|OG001|Outcome|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
10947708|NCT00795366|EG000|Reported Event|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
10947709|NCT00795366|EG001|Reported Event|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
10947710|NCT00795509|BG000|Baseline|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
10947711|NCT00795509|FG000|Participant Flow|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
10947712|NCT00795509|OG000|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
10947713|NCT00795509|EG000|Reported Event|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
10947714|NCT00795535|BG000|Baseline|Trauma Patients|Patients transported to the trauma center by helicopter
10947715|NCT00795535|FG000|Participant Flow|Trauma Patients|Patients transported to the trauma center by helicopter
10947716|NCT00795535|OG000|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
10947717|NCT00795535|EG000|Reported Event|Trauma Patients|Patients transported to the trauma center by helicopter
10947718|NCT00795600|BG000|Baseline|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
11192202|NCT02137772|EG000|Reported Event|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
11341731|NCT03687684|OG004|Outcome|Japanese Cohort 2: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10947719|NCT00795600|BG001|Baseline|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
10947720|NCT00795600|BG002|Baseline|Total|Total of all reporting groups
10947721|NCT00795600|FG000|Participant Flow|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
10947722|NCT00795600|FG001|Participant Flow|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
10947723|NCT00795600|OG000|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
10947724|NCT00795600|OG001|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
10947725|NCT00795600|EG000|Reported Event|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
10947726|NCT00795600|EG001|Reported Event|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
10947727|NCT00795639|BG000|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
10947728|NCT00795639|BG001|Baseline|Placebo|Matching placebo tablet once a day
10947729|NCT00795639|BG002|Baseline|Total|Total of all reporting groups
10947730|NCT00795639|FG000|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
10947731|NCT00795639|FG001|Participant Flow|Placebo|Matching placebo tablet once a day
10947732|NCT00795639|OG000|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
10947733|NCT00795639|OG001|Outcome|Placebo|Matching placebo tablet once a day
10947734|NCT00795639|EG000|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
10947735|NCT00795639|EG001|Reported Event|Placebo|Matching placebo tablet once a day
10947736|NCT00795704|BG000|Baseline|Placebo|Control Group
10947737|NCT00795704|BG001|Baseline|Mulberry Leaf Extract|500 mg #2 capsules three times daily
10947738|NCT00795704|BG002|Baseline|Total|Total of all reporting groups
10947739|NCT00795704|FG000|Participant Flow|Placebo|Control Group
10947740|NCT00795704|FG001|Participant Flow|Mulberry Leaf Extract|500 mg #2 capsules three times daily
10947741|NCT00795704|OG000|Outcome|Placebo|Control Group
10947742|NCT00795704|OG001|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
10947743|NCT00795704|EG000|Reported Event|Placebo|Control Group
10947744|NCT00795704|EG001|Reported Event|Mulberry Leaf Extract|500 mg #2 capsules three times daily
10947745|NCT00795717|BG000|Baseline|Lovaza Then Placebo|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
10947746|NCT00795717|BG001|Baseline|Placebo Then Lovaza|"Placebo or Corn oil pill, dietary counseling~Corn oil pill : 2 capsules given twice daily for 12 weeks"
10947747|NCT00795717|BG002|Baseline|Total|Total of all reporting groups
10947748|NCT00795717|FG000|Participant Flow|Lovaza Then Placebo|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks vs. placebo 2 capsules given twice daily."
10947749|NCT00795717|FG001|Participant Flow|Placebo Then Lovaza|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily vs. Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks"
10947750|NCT00795717|OG000|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
10947751|NCT00795717|OG001|Outcome|Placebo|"Corn oil, dietary counseling~Corn oil : 2 capsules given twice daily"
10947752|NCT00795717|OG001|Outcome|Placebo|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily"
10947753|NCT00795717|EG000|Reported Event|Lovaza-Active|Lovaza, dietary counseling
10947754|NCT00795717|EG001|Reported Event|Placebo|Placebo, dietary counseling
10947755|NCT00795769|BG000|Baseline|Ondansteron Therapy|"Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
10947756|NCT00795769|FG000|Participant Flow|Ondansetron Therapy|"Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
11177834|NCT02044159|BG000|Baseline|Hydrocortisone|"Patients randomized to the hydrocortisone arm will receive a 2 mg/kg hydrocortisone IV bolus on enrolment followed by 1 mg/kg of hydrocortisone IV q6h until the patient has not had an escalation in therapy for at least 12 hours. If the patient meets these criteria their hydrocortisone will be weaned to 1 mg/kg every 8 hours which will be continued until they are off all vasoactive infusions for 12 hours. If following the initial hydrocortisone wean, the patient requires fluid boluses and/or an increase in their vasoactive infusion(s), their hydrocortisone will be increased back to 1 mg/kg of hydrocortisone IV q6h until they meet stability criteria again. Duration of treatment will range from a minimum of 20 hours to a maximum of 7 days of study drug.~Hydrocortisone: Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg)."
11177835|NCT02044159|BG001|Baseline|Placebo|"Patients randomized to the placebo arm will receive a placebo solution consisting of normal saline equivalent in volume to the appropriate dose of hydrocortisone. Hydrocortisone and placebo will be identical in appearance, volume and smell as hydrocortisone is made up in normal saline and dissolves completely with no visible precipitate. The dosing regimen will be identical to the hydrocortisone arm.~Placebo: The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone)."
11177836|NCT02044159|BG002|Baseline|Total|Total of all reporting groups
10947757|NCT00795769|OG000|Outcome|Ondansetron Therapy|"Patients receive 16mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
10947758|NCT00795769|EG000|Reported Event|Ondansteron Therapy|"Patients receive 16 mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
10947759|NCT00795821|BG000|Baseline|LY2216684|"10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.~1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
10947760|NCT00795821|BG001|Baseline|Placebo|"10-week Acute Treatment Phase: 3 tablets QD for 10 weeks~1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
10947761|NCT00795821|BG002|Baseline|Total|Total of all reporting groups
10947762|NCT00795821|FG000|Participant Flow|LY2216684|"10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.~1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
10947763|NCT00795821|FG001|Participant Flow|Placebo|"10-week Acute Treatment Phase: 3 tablets QD for 10 weeks~1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
10947764|NCT00795821|OG000|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
10947765|NCT00795821|OG001|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
10947766|NCT00795821|OG000|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
10947767|NCT00795821|OG001|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
10947768|NCT00795821|OG001|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684 dose; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
10947769|NCT00795821|OG000|Outcome|LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
10947770|NCT00795821|OG001|Outcome|Placebo|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
10947771|NCT00795821|OG000|Outcome|LY2216684|"10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.~1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of acute treatment phase, or 6 mg LY2216684 dose if participants were taking placebo; After Week 1=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
10947772|NCT00795821|EG000|Reported Event|LY2216684 - Acute|10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
10947773|NCT00795821|EG001|Reported Event|Placebo - Acute|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
10947774|NCT00795821|EG002|Reported Event|LY2216684/LY2216684 - Extension|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
10947775|NCT00795821|EG003|Reported Event|Placebo/LY2216684 - Extension|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
10947776|NCT00795821|EG004|Reported Event|LY2216684 - Taper|Participants who took 18 mg LY2216684 received 12 mg QD for 1 week followed by 6 mg QD for 1 week. Participants who took 12 mg, 9 mg, or 6 mg LY2216684 received 6 mg QD for 2 weeks.
10947777|NCT00795821|EG005|Reported Event|Placebo - Taper|Participants who took placebo remained on placebo for 2 weeks.
10947778|NCT00795886|BG000|Baseline|Rapamycin|This includes all study participants.
10947779|NCT00795886|FG000|Participant Flow|Rapamycin|This includes all study participants.
10947780|NCT00795886|OG000|Outcome|Rate of Transplant Related Mortality|All participants enrolled in the trial
10947781|NCT00795886|OG000|Outcome|Rapamycin|This includes all study participants.
10947782|NCT00795886|EG000|Reported Event|Rapamycin|This includes all study participants.
10947783|NCT00795951|BG000|Baseline|Single Arm Study|All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1
10947784|NCT00795951|FG000|Participant Flow|All Subjects|T.R.U.E. Test Allergen Panel evaluations
10947785|NCT00795951|OG000|Outcome|All Subjects|T.R.U.E. Test allergen panel evaluations
10947786|NCT00795951|OG000|Outcome|Diagnostic Performance|T.R.U.E. Test allergen panel evaluations
10947787|NCT00795951|EG000|Reported Event|Safety|Adverse Events
10947788|NCT00796003|BG000|Baseline|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
10947789|NCT00796003|BG001|Baseline|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
10947790|NCT00796003|BG002|Baseline|Total|Total of all reporting groups
10947791|NCT00796003|FG000|Participant Flow|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
10947792|NCT00796003|FG001|Participant Flow|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
10947793|NCT00796003|OG000|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
10947794|NCT00796003|OG000|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
10947795|NCT00796003|OG001|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
10947796|NCT00796003|OG002|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
10947797|NCT00796003|EG000|Reported Event|Phase I - 15 mg/m2 Group|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
10947798|NCT00796003|EG001|Reported Event|Phase I - 20 mg/m2 Group|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
10947799|NCT00796003|EG002|Reported Event|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
11341732|NCT03687684|OG005|Outcome|Japanese Cohort 4: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341733|NCT03687684|OG006|Outcome|Japanese Cohort 5: TAK-831 50 mg|TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341734|NCT03687684|OG007|Outcome|Chinese Cohort 3: Placebo|TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
11341735|NCT03687684|OG008|Outcome|Chinese Cohort 3: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
11341736|NCT03687684|OG000|Outcome|Japanese Cohort 1: TAK-831 100 mg|TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
10947800|NCT00796120|BG000|Baseline|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
10947801|NCT00796120|BG001|Baseline|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
10947802|NCT00796120|BG002|Baseline|Total|Total of all reporting groups
10947803|NCT00796120|FG000|Participant Flow|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
10947804|NCT00796120|FG001|Participant Flow|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
10947805|NCT00796120|OG000|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
10947806|NCT00796120|OG001|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
10947807|NCT00796120|EG000|Reported Event|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
10947808|NCT00796120|EG001|Reported Event|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
10947809|NCT00796224|BG000|Baseline|60 mg/kg Azithromycin ER|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
10947810|NCT00796224|BG001|Baseline|30 mg/kg Azithromycin IR|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
10947811|NCT00796224|BG002|Baseline|Total|Total of all reporting groups
10947812|NCT00796224|FG000|Participant Flow|60 mg/kg Azithromycin Extended-release (ER)|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
10947813|NCT00796224|FG001|Participant Flow|30 mg/kg Azithromycin Immediate-release (IR)|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
10947814|NCT00796224|OG000|Outcome|60 mg/kg Azithromycin ER|
10947815|NCT00796224|OG001|Outcome|30 mg/kg Azithromycin IR|
10947816|NCT00796224|OG000|Outcome|60 mg/kg Azithromycin ER (Test)|
10947817|NCT00796224|OG001|Outcome|30 mg/kg Azithromycin IR (Reference)|
10947818|NCT00796224|EG000|Reported Event|60 mg/kg Azithromycin ER|
10947819|NCT00796224|EG001|Reported Event|30 mg/kg Azithromycin IR|
10947820|NCT00796302|BG000|Baseline|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
10947821|NCT00796302|BG001|Baseline|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
10947822|NCT00796302|BG002|Baseline|Total|Total of all reporting groups
10947823|NCT00796302|FG000|Participant Flow|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
10947824|NCT00796302|FG001|Participant Flow|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
10947825|NCT00796302|OG000|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
10947826|NCT00796302|OG001|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and risperidone. Parents will receive parent management training
10947827|NCT00796302|OG001|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
10947828|NCT00796302|EG000|Reported Event|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
10947829|NCT00796302|EG001|Reported Event|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
10947830|NCT00796315|BG000|Baseline|Doxylamine Succinate USP|Doxylamine Succinate, United States Pharmacopeia (USP): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
10947831|NCT00796315|FG000|Participant Flow|Subjects Aged 2-5 Years (Doxylamine Succinate)|Ages 2-5 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
10947832|NCT00796315|FG001|Participant Flow|Aged 6-11 Years (Doxylamine Succinate|"Ages 6-11 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.~Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued."
10947833|NCT00796315|FG002|Participant Flow|Subjects Aged 12-17 Years (Doxylamine Suc|Ages 12-17 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
10947834|NCT00796315|OG000|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Subjects received a dose of either 3.125 or 4.17 mg Doxylamine Succinate USP (exact dose dependent upon body weight)
10947835|NCT00796315|OG001|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Subjects received a dose of 4.17 or 6.25 or 8.33 or 10.42 mg Doxylamine Succinate USP (exact dose dependent upon body weight). Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued.
10947836|NCT00796315|OG002|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. All subjects received a dose of 12.5 mg Doxylamine Succinate USP
10947837|NCT00796315|OG000|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
10947838|NCT00796315|OG001|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
10947839|NCT00796315|OG002|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine Succinate USP
10947840|NCT00796315|EG000|Reported Event|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
10947841|NCT00796315|EG001|Reported Event|Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
10947842|NCT00796315|EG002|Reported Event|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine succinate USP
10947843|NCT00796328|BG000|Baseline|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
10947844|NCT00796328|FG000|Participant Flow|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
10947845|NCT00796328|OG000|Outcome|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
10947846|NCT00796328|EG000|Reported Event|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
10947847|NCT00796367|BG000|Baseline|Placebo|Placebo
10947848|NCT00796367|BG001|Baseline|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
10947849|NCT00796367|BG002|Baseline|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
10947850|NCT00796367|BG003|Baseline|Total|Total of all reporting groups
10947851|NCT00796367|FG000|Participant Flow|Placebo|Placebo
10947852|NCT00796367|FG001|Participant Flow|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
10947853|NCT00796367|FG002|Participant Flow|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
10947854|NCT00796367|OG000|Outcome|Placebo|Placebo
10947855|NCT00796367|OG001|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
10947856|NCT00796367|OG002|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
10947857|NCT00796367|EG000|Reported Event|Placebo|Placebo
10947858|NCT00796367|EG001|Reported Event|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
10947859|NCT00796367|EG002|Reported Event|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
10947860|NCT00796419|BG000|Baseline|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
10947861|NCT00796419|BG001|Baseline|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
10947862|NCT00796419|BG002|Baseline|Total|Total of all reporting groups
10947863|NCT00796419|FG000|Participant Flow|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 5% human albumin every 8 hours for 5 days
10947864|NCT00796419|FG001|Participant Flow|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 6% hetastarch every 8 hours for 5 days
10947865|NCT00796419|OG000|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
10947866|NCT00796419|OG001|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
10947867|NCT00796419|EG000|Reported Event|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
10947868|NCT00796419|EG001|Reported Event|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
10947869|NCT00796445|BG000|Baseline|MAGE-A3 Group|Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCIStudy products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
10947870|NCT00796445|BG001|Baseline|Placebo Group|Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
10947871|NCT00796445|BG002|Baseline|Total|Total of all reporting groups
10947872|NCT00796445|FG000|Participant Flow|MAGE-A3 Group|Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
10947873|NCT00796445|FG001|Participant Flow|Placebo Group|Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
10947874|NCT00796445|OG000|Outcome|MAGE-A3 Group|Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
10947875|NCT00796445|OG001|Outcome|Placebo Group|Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
10947876|NCT00796445|OG002|Outcome|GS+ Mage-A3 Sub-Group|Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
11341737|NCT03687684|OG001|Outcome|Japanese Cohort 1: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
10947877|NCT00796445|OG003|Outcome|GS+ Placebo Sub-Group|Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
10947878|NCT00796445|OG004|Outcome|GS- Mage-A3 Sub-Group|Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
10947879|NCT00796445|OG005|Outcome|GS- Placebo Sub-Group|Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
10947880|NCT00796445|OG002|Outcome|GS+ Mage-A3 Sub-Group|Subset of patients with the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
10947881|NCT00796445|OG004|Outcome|GS- Mage-A3 Sub-Group|Subset of patients without the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
10947882|NCT00796445|OG003|Outcome|GS- Mage-A3 Sub-Group|Subset of patients without the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
10947883|NCT00796445|OG004|Outcome|GS+ Placebo Sub-Group|Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
10947884|NCT00796445|EG000|Reported Event|MAGE-A3 Group|Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
10947885|NCT00796445|EG001|Reported Event|Placebo Group|Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
10947886|NCT00796549|BG000|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
10947887|NCT00796549|FG000|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
10947888|NCT00796549|OG000|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
10947889|NCT00796549|OG000|Outcome|Afatinib 50mg 1st Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 1st line anti cancer treatment, indicating that they had not received prior treatment with chemotherapy.
10947890|NCT00796549|OG001|Outcome|Afatinib 50mg 2nd Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
10947891|NCT00796549|EG000|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors)
10947892|NCT00796562|BG000|Baseline|Myeloablative Haploidentical BMT|"All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days.~Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days."
11177837|NCT02044159|FG000|Participant Flow|Hydrocortisone|"Patients randomized to the hydrocortisone arm will receive a 2 mg/kg hydrocortisone IV bolus on enrolment followed by 1 mg/kg of hydrocortisone IV q6h until the patient has not had an escalation in therapy for at least 12 hours. If the patient meets these criteria their hydrocortisone will be weaned to 1 mg/kg every 8 hours which will be continued until they are off all vasoactive infusions for 12 hours. If following the initial hydrocortisone wean, the patient requires fluid boluses and/or an increase in their vasoactive infusion(s), their hydrocortisone will be increased back to 1 mg/kg of hydrocortisone IV q6h until they meet stability criteria again. Duration of treatment will range from a minimum of 20 hours to a maximum of 7 days of study drug.~Hydrocortisone: Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg)."
11177838|NCT02044159|FG001|Participant Flow|Placebo|"Patients randomized to the placebo arm will receive a placebo solution consisting of normal saline equivalent in volume to the appropriate dose of hydrocortisone. Hydrocortisone and placebo will be identical in appearance, volume and smell as hydrocortisone is made up in normal saline and dissolves completely with no visible precipitate. The dosing regimen will be identical to the hydrocortisone arm.~Placebo: The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone)."
11177839|NCT02044159|OG000|Outcome|Full Cohort|Feasibility outcomes were analyzed for the full cohort, and not compared between groups
11177840|NCT02044159|OG000|Outcome|Full Cohort|Feasibility objectives were assessed for the full cohort, and not compared between study arms
11177841|NCT02044159|OG000|Outcome|Hydrocortisone|"Patients randomized to the hydrocortisone arm will receive a 2 mg/kg hydrocortisone IV bolus on enrolment followed by 1 mg/kg of hydrocortisone IV q6h until the patient has not had an escalation in therapy for at least 12 hours. If the patient meets these criteria their hydrocortisone will be weaned to 1 mg/kg every 8 hours which will be continued until they are off all vasoactive infusions for 12 hours. If following the initial hydrocortisone wean, the patient requires fluid boluses and/or an increase in their vasoactive infusion(s), their hydrocortisone will be increased back to 1 mg/kg of hydrocortisone IV q6h until they meet stability criteria again. Duration of treatment will range from a minimum of 20 hours to a maximum of 7 days of study drug.~Hydrocortisone: Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg)."
11177842|NCT02044159|OG001|Outcome|Placebo|"Patients randomized to the placebo arm will receive a placebo solution consisting of normal saline equivalent in volume to the appropriate dose of hydrocortisone. Hydrocortisone and placebo will be identical in appearance, volume and smell as hydrocortisone is made up in normal saline and dissolves completely with no visible precipitate. The dosing regimen will be identical to the hydrocortisone arm.~Placebo: The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone)."
11177843|NCT02044159|OG000|Outcome|Full Cohort|Measured in aggregate for full cohort
11177844|NCT02044159|EG000|Reported Event|Hydrocortisone|"Patients randomized to the hydrocortisone arm will receive a 2 mg/kg hydrocortisone IV bolus on enrolment followed by 1 mg/kg of hydrocortisone IV q6h until the patient has not had an escalation in therapy for at least 12 hours. If the patient meets these criteria their hydrocortisone will be weaned to 1 mg/kg every 8 hours which will be continued until they are off all vasoactive infusions for 12 hours. If following the initial hydrocortisone wean, the patient requires fluid boluses and/or an increase in their vasoactive infusion(s), their hydrocortisone will be increased back to 1 mg/kg of hydrocortisone IV q6h until they meet stability criteria again. Duration of treatment will range from a minimum of 20 hours to a maximum of 7 days of study drug.~Hydrocortisone: Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg)."
11177845|NCT02044159|EG001|Reported Event|Placebo|"Patients randomized to the placebo arm will receive a placebo solution consisting of normal saline equivalent in volume to the appropriate dose of hydrocortisone. Hydrocortisone and placebo will be identical in appearance, volume and smell as hydrocortisone is made up in normal saline and dissolves completely with no visible precipitate. The dosing regimen will be identical to the hydrocortisone arm.~Placebo: The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone)."
11177846|NCT02044367|BG000|Baseline|Overall|A randomised, open-label, 3-way crossover, multiple dose trial consisting of 3 identical treatment periods of 3 days. Study drug (150 mg dabigatran etexilate) was administrated twice daily on Day 1 and Day 2 and once on Day 3. The dosage forms used were: hard capsule, granules resolved in reconstitution solution and pellets on food. Treatment periods were separated by a washout phase of at least 5 days between last drug administration of one treatment and the first drug administration of the next treatment.
11177847|NCT02044367|FG000|Participant Flow|T1-T2-R|T1: pellets on food; T2: granules for reconstitution into solution; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177848|NCT02044367|FG001|Participant Flow|T1-R-T2|T1: pellets on food; R: hard capsule; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177849|NCT02044367|FG002|Participant Flow|T2-T1-R|T2: granules for reconstitution into solution; T1: pellets on food; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177850|NCT02044367|FG003|Participant Flow|T2-R-T1|T2: granules for reconstitution into solution; R: hard capsule; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177851|NCT02044367|FG004|Participant Flow|R-T1-T2|R: hard capsule; T1: pellets on food; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177852|NCT02044367|FG005|Participant Flow|R-T2-T1|R: hard capsule; T2: granules for reconstitution into solution; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177853|NCT02044367|OG000|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
11341738|NCT03687684|OG002|Outcome|Japanese Cohort 2: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10947893|NCT00796562|FG000|Participant Flow|Myeloablative Haploidentical BMT|"All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days.~Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days."
10947894|NCT00796562|OG000|Outcome|Myeloablative Haploidentical BMT|"All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days.~Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days."
10947895|NCT00796562|EG000|Reported Event|Myeloablative Haploidentical BMT|"All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days.~Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days."
10947896|NCT00796614|BG000|Baseline|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947897|NCT00796614|BG001|Baseline|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947898|NCT00796614|BG002|Baseline|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947899|NCT00796614|BG003|Baseline|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947900|NCT00796614|BG004|Baseline|Total|Total of all reporting groups
10947901|NCT00796614|FG000|Participant Flow|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947902|NCT00796614|FG001|Participant Flow|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
11177854|NCT02044367|OG001|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
10947903|NCT00796614|FG002|Participant Flow|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947904|NCT00796614|FG003|Participant Flow|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947905|NCT00796614|OG000|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
11177855|NCT02044367|OG002|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
11177856|NCT02044367|OG000|Outcome|T1 (Treatment A)|T1: Pellets on food The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
10947906|NCT00796614|OG001|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947907|NCT00796614|OG002|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
11177857|NCT02044367|OG001|Outcome|T2 (Treatment B)|T2: Granules resolved in reconstitution solution The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
11177858|NCT02044367|OG000|Outcome|T1 (Treatment A)|"T1: Pellets on food~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
11177859|NCT02044367|OG001|Outcome|T2 (Treatment B)|"T2: Granules resolved in reconstitution solution~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
10947908|NCT00796614|OG003|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947909|NCT00796614|EG000|Reported Event|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947910|NCT00796614|EG001|Reported Event|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947911|NCT00796614|EG002|Reported Event|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
10947912|NCT00796614|EG003|Reported Event|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
11177860|NCT02044367|EG000|Reported Event|T1 (Treatment A)|multiple dose of dabigatran (Pellets). The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177861|NCT02044367|EG001|Reported Event|T2 (Treatment B)|multiple dose of dabigatran (Granules resolved in reconstitution solution) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177862|NCT02044367|EG002|Reported Event|R (Reference)|multiple dose of dabigatran (Hard capsule) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
11177863|NCT02044380|BG000|Baseline|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
11177864|NCT02044380|FG000|Participant Flow|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
11177865|NCT02044380|OG000|Outcome|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
11177866|NCT02044380|EG000|Reported Event|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
10947913|NCT00796627|BG000|Baseline|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
10947914|NCT00796627|BG001|Baseline|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
10947915|NCT00796627|BG002|Baseline|Total|Total of all reporting groups
10947916|NCT00796627|FG000|Participant Flow|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
10947917|NCT00796627|FG001|Participant Flow|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
10947918|NCT00796627|OG000|Outcome|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
10947919|NCT00796627|OG001|Outcome|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
10947920|NCT00796627|EG000|Reported Event|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
10947921|NCT00796627|EG001|Reported Event|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
10947922|NCT00796653|BG000|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10947923|NCT00796653|BG001|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10947924|NCT00796653|BG002|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10947925|NCT00796653|BG003|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10947926|NCT00796653|BG004|Baseline|Total|Total of all reporting groups
10947927|NCT00796653|FG000|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10947928|NCT00796653|FG001|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10947929|NCT00796653|FG002|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10947930|NCT00796653|FG003|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10947931|NCT00796653|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10947932|NCT00796653|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10947933|NCT00796653|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10947934|NCT00796653|OG003|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10947935|NCT00796653|OG000|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
10947936|NCT00796653|OG001|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
10947937|NCT00796653|OG002|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
10947938|NCT00796653|OG003|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
10947939|NCT00796653|OG004|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
10947940|NCT00796653|OG005|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
10947941|NCT00796653|OG006|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
10947942|NCT00796653|OG007|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
10947943|NCT00796653|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10947944|NCT00796653|EG001|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10947945|NCT00796653|EG002|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10947946|NCT00796653|EG003|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10947947|NCT00796666|BG000|Baseline|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
10947948|NCT00796666|BG001|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
10947949|NCT00796666|BG002|Baseline|Total|Total of all reporting groups
10947950|NCT00796666|FG000|Participant Flow|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
10947951|NCT00796666|FG001|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
10947952|NCT00796666|OG000|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
10947953|NCT00796666|OG001|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
10947954|NCT00796666|EG000|Reported Event|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
10947955|NCT00796666|EG001|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
10947956|NCT00796705|BG000|Baseline|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
10947957|NCT00796705|BG001|Baseline|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
10947958|NCT00796705|BG002|Baseline|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
10947959|NCT00796705|BG003|Baseline|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
10947960|NCT00796705|BG004|Baseline|Total|Total of all reporting groups
10947961|NCT00796705|FG000|Participant Flow|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
11341739|NCT03687684|OG003|Outcome|Japanese Cohort 4: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341740|NCT03687684|OG004|Outcome|Japanese Cohort 5: TAK-831 50 mg|TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10947962|NCT00796705|FG001|Participant Flow|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
10947963|NCT00796705|FG002|Participant Flow|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
10947964|NCT00796705|FG003|Participant Flow|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
10947965|NCT00796705|OG000|Outcome|Non-Switcher/ Adalimumab or Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion and participants defined as etanercept failures [2] at screening who were randomized to receive etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.~Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
11177867|NCT02044393|BG000|Baseline|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.~The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.~Oral administration with 240 mL water after intake of a standardised meal."
11177868|NCT02044393|BG001|Baseline|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.~Oral administration with 240 mL water after intake of a standaridsed meal."
11177869|NCT02044393|BG002|Baseline|Total|Total of all reporting groups
11177870|NCT02044393|FG000|Participant Flow|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.~The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.~Oral administration with 240 mL water after intake of a standardised meal."
11177871|NCT02044393|FG001|Participant Flow|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.~Oral administration with 240 mL water after intake of a standaridsed meal."
11177872|NCT02044393|OG000|Outcome|BI 691751|"single dose BI 691751~BI 691751: 10 mg single dose oral administration with 240 mL water after intake of a standard meal."
11177873|NCT02044393|OG001|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
11177874|NCT02044393|OG000|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
11177875|NCT02044393|EG000|Reported Event|BI 691751|10 mg single dose oral administration with 240 mL water after intake of a standard meal. (only in the reference treatment period)
11177876|NCT02044393|EG001|Reported Event|Loading Itraconazole (IT)|200 mg of itraconazole (introductory treatment with itraconazole over three days, prior to the first administration of BI 691751 only in the test treatment period).
11177877|NCT02044393|EG002|Reported Event|BI 691751 + Further IT|10 mg of BI 691751 in combination with multiple oral doses of itraconazole (only in the test treatment period after the introductory treatment with itraconazole alone over three days).
11177878|NCT02044393|EG003|Reported Event|Total BI 691751|total subjects with BI 691751 treatment (either BI 691751 alone or IT+BI 691751)
11177879|NCT02044393|EG004|Reported Event|Total on Treatment|combination of BI 691751, loading IT and BI 691751+ further IT.
11177880|NCT02044419|BG000|Baseline|Applesauce, Mashed Banana, Intact Capsule (ABC)|"Contents of single 20 mg capsule of lomitapide sprinkled in applesauce, mashed banana~Capsule taken intact~lomitapide"
11177881|NCT02044419|BG001|Baseline|Mashed Banana, Intact Capsule, Applesauce (BCA)|"Contents of single 20 mg capsule of lomitapide sprinkled in applesauce& mashed banana~Capsule taken intact~lomitapide"
10947966|NCT00796705|OG001|Outcome|Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion and participants defined as etanercept failures [2] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg SQ injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.~Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
10947967|NCT00796705|OG000|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
10947968|NCT00796705|OG001|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
10947969|NCT00796705|OG002|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
10947970|NCT00796705|OG003|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
10947971|NCT00796705|EG000|Reported Event|Non-Switcher/Adalimumab|Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab
11177882|NCT02044419|BG002|Baseline|Intact Capsule, Applesauce, Mashed Banana (CAB)|"Contents of single 20 mg capsule of lomitapide sprinkled in applesauce& mashed banana~Capsule taken intact~lomitapide"
11177883|NCT02044419|BG003|Baseline|Total|Total of all reporting groups
11177884|NCT02044419|FG000|Participant Flow|Applesauce, Mashed Banana, Intact Capsule (ABC)|First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Second Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Third Intervention: Intact capsule of 20 mg lomitapide
10947972|NCT00796705|EG001|Reported Event|Non-Switcher/Etanercept|Subjects failing Etanercept at screening who were randomized to remain on Etanercept
10947973|NCT00796705|EG002|Reported Event|Switcher/Adalimumab to Etanercept|Subjects failing Adalimumab at screening who were randomized to switch to Etanercept
10947974|NCT00796705|EG003|Reported Event|Switcher/Etanercept to Adalimumab|Subjects failing Etanercept at screening who were randomized to switch to Adalimumab
10947975|NCT00796718|BG000|Baseline|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
10947976|NCT00796718|FG000|Participant Flow|Capecitabine|Capecitabine 825 milligrams per meter square (mg/m^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
10947977|NCT00796718|OG000|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
10947978|NCT00796718|EG000|Reported Event|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
11177885|NCT02044419|FG001|Participant Flow|Mashed Banana, Intact Capsule, Applesauce (BCA)|First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Second Intervention: Intact capsule of 20 mg lomitapide Third Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
11177886|NCT02044419|FG002|Participant Flow|Intact Capsule, Applesauce, Mashed Banana (CAB)|First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Second Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Third Intervention: Intact capsule of 20 mg lomitapide
11177887|NCT02044419|OG000|Outcome|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
11177888|NCT02044419|OG001|Outcome|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
11177889|NCT02044419|OG002|Outcome|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
11177890|NCT02044419|EG000|Reported Event|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
11177891|NCT02044419|EG001|Reported Event|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
11177892|NCT02044419|EG002|Reported Event|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
11177893|NCT02044458|BG000|Baseline|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
10947979|NCT00796744|BG000|Baseline|Placebo Vehicle Control|control placebo vehicle
10947980|NCT00796744|BG001|Baseline|0.03 % DSC127|0.03% DSC127 in Vehicle Control
10947981|NCT00796744|BG002|Baseline|0.01% DSC127|0.01% DSC127 in Vehicle Control
11177894|NCT02044458|BG001|Baseline|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
10947982|NCT00796744|BG003|Baseline|Total|Total of all reporting groups
11177895|NCT02044458|BG002|Baseline|Total|Total of all reporting groups
11177896|NCT02044458|FG000|Participant Flow|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
11177897|NCT02044458|FG001|Participant Flow|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
11177898|NCT02044458|OG000|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
11177899|NCT02044458|OG001|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
11177900|NCT02044458|EG000|Reported Event|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
11177901|NCT02044458|EG001|Reported Event|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
11177902|NCT02044510|BG000|Baseline|Mirabegron|"Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks).~Mirabegron: Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks."
11177903|NCT02044510|BG001|Baseline|Placebo|"Inert placebo pill, matching active treatment pill.~Placebo: Matched placebo capsules to the intervention arm"
11177904|NCT02044510|BG002|Baseline|Total|Total of all reporting groups
11177905|NCT02044510|FG000|Participant Flow|Mirabegron|"Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks).~Mirabegron: Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks."
11177906|NCT02044510|FG001|Participant Flow|Placebo|"Inert placebo pill, matching active treatment pill.~Placebo: Matched placebo capsules to the intervention arm"
11177907|NCT02044510|OG000|Outcome|Mirabegron|"Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks).~Mirabegron: Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks."
11177908|NCT02044510|OG001|Outcome|Placebo|"Inert placebo pill, matching active treatment pill.~Placebo: Matched placebo capsules to the intervention arm"
11177909|NCT02044510|EG000|Reported Event|Mirabegron|"Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks).~Mirabegron: Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks."
11177910|NCT02044510|EG001|Reported Event|Placebo|"Inert placebo pill, matching active treatment pill.~Placebo: Matched placebo capsules to the intervention arm"
11177911|NCT02044796|BG000|Baseline|Newly Diagnosed|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV"
11177912|NCT02044796|BG001|Baseline|Relapsed/Refractory Group|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV"
11177913|NCT02044796|BG002|Baseline|Total|Total of all reporting groups
10947983|NCT00796744|FG000|Participant Flow|Placebo Vehicle Control|control placebo vehicle
10947984|NCT00796744|FG001|Participant Flow|0.03 % DSC127|0.03% DSC127 in Vehicle Control
10947985|NCT00796744|FG002|Participant Flow|0.01% DSC127|0.01% DSC127 in Vehicle Control
10947986|NCT00796744|OG000|Outcome|Placebo|control placebo vehicle
10947987|NCT00796744|OG001|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
10947988|NCT00796744|OG002|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
10947989|NCT00796744|OG000|Outcome|Placebo Vehicle Control|control placebo vehicle
10947990|NCT00796744|OG001|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
10947991|NCT00796744|EG000|Reported Event|Placebo Vehicle Control|control placebo vehicle
10947992|NCT00796744|EG001|Reported Event|0.03 % DSC127|0.03% DSC127 in Vehicle Control
10947993|NCT00796744|EG002|Reported Event|0.01% DSC127|0.01% DSC127 in Vehicle Control
10947994|NCT00796757|BG000|Baseline|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
10947995|NCT00796757|FG000|Participant Flow|Bevacizumab Plus (+) Interferon|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 and Interferon alpha-2a (IFN) 3 million international units (MIU) subcutaneously (SC) 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
10947996|NCT00796757|OG000|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
10947997|NCT00796757|EG000|Reported Event|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
10947998|NCT00796822|BG000|Baseline|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
10947999|NCT00796822|BG001|Baseline|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
10948000|NCT00796822|BG002|Baseline|Total|Total of all reporting groups
10948001|NCT00796822|FG000|Participant Flow|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
10948002|NCT00796822|FG001|Participant Flow|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
10948003|NCT00796822|OG000|Outcome|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
10948004|NCT00796822|OG001|Outcome|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
10948005|NCT00796822|EG000|Reported Event|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
10948006|NCT00796822|EG001|Reported Event|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
10948007|NCT00796926|BG000|Baseline|Systane Ultra|four times a day for six weeks in each eye
10948008|NCT00796926|BG001|Baseline|Refresh|Four times a day for 6 weeks in each eye
10948009|NCT00796926|BG002|Baseline|Total|Total of all reporting groups
10948010|NCT00796926|FG000|Participant Flow|Systane Ultra|four times a day for six weeks in each eye
10948011|NCT00796926|FG001|Participant Flow|Refresh|Four times a day for 6 weeks in each eye
10948012|NCT00796926|OG000|Outcome|Systane Ultra|four times a day for six weeks in each eye
10948013|NCT00796926|OG001|Outcome|Refresh|Four times a day for 6 weeks in each eye
10948014|NCT00796926|EG000|Reported Event|Systane Ultra|four times a day for six weeks in each eye
10948015|NCT00796926|EG001|Reported Event|Refresh|Four times a day for 6 weeks in each eye
10948016|NCT00796978|BG000|Baseline|Trastuzumab|"trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).~adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52."
10948017|NCT00796978|FG000|Participant Flow|Trastuzumab|"trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).~adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52."
10948018|NCT00796978|OG000|Outcome|Trastuzumab|"trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).~adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52."
10948019|NCT00796978|EG000|Reported Event|Trastuzumab|"trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).~adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52."
11192203|NCT02137772|EG001|Reported Event|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
10948020|NCT00796991|BG000|Baseline|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948021|NCT00796991|BG001|Baseline|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948022|NCT00796991|BG002|Baseline|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948023|NCT00796991|BG003|Baseline|Total|Total of all reporting groups
10948024|NCT00796991|FG000|Participant Flow|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948025|NCT00796991|FG001|Participant Flow|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948026|NCT00796991|FG002|Participant Flow|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
11192204|NCT02137785|BG000|Baseline|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
10948027|NCT00796991|OG000|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948028|NCT00796991|OG001|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948029|NCT00796991|OG002|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948030|NCT00796991|EG000|Reported Event|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
11192205|NCT02137785|BG001|Baseline|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
11192206|NCT02137785|BG002|Baseline|Total|Total of all reporting groups
10948031|NCT00796991|EG001|Reported Event|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948032|NCT00796991|EG002|Reported Event|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
10948033|NCT00797108|BG000|Baseline|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948034|NCT00797108|BG001|Baseline|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948035|NCT00797108|BG002|Baseline|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948036|NCT00797108|BG003|Baseline|Total|Total of all reporting groups
11177914|NCT02044796|FG000|Participant Flow|Newly Diagnosed Group Mitoxantrone Hydrochloride 12 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11192207|NCT02137785|FG000|Participant Flow|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
11192208|NCT02137785|FG001|Participant Flow|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
10948037|NCT00797108|FG000|Participant Flow|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948038|NCT00797108|FG001|Participant Flow|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948039|NCT00797108|FG002|Participant Flow|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
11192209|NCT02137785|OG000|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
10948040|NCT00797108|OG000|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948041|NCT00797108|OG001|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948042|NCT00797108|OG002|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948043|NCT00797108|EG000|Reported Event|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948044|NCT00797108|EG001|Reported Event|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948045|NCT00797108|EG002|Reported Event|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
10948046|NCT00797212|BG000|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm
10948047|NCT00797212|FG000|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
11192210|NCT02137785|OG001|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
10948048|NCT00797212|OG000|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
10948049|NCT00797212|EG000|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
10948050|NCT00797225|BG000|Baseline|Placebo|Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.
10948051|NCT00797225|BG001|Baseline|Elagolix 150 mg|Participants received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.
10948052|NCT00797225|BG002|Baseline|Elagolix 250 mg|Participants received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
10948053|NCT00797225|BG003|Baseline|Leuprorelin|Participants received placebo tablets once a day and leuprorelin acetate 1-month depot 3.75 mg intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.
10948054|NCT00797225|BG004|Baseline|Total|Total of all reporting groups
10948055|NCT00797225|FG000|Participant Flow|Placebo|Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.
11192211|NCT02137785|EG000|Reported Event|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
11192212|NCT02137785|EG001|Reported Event|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
10948056|NCT00797225|FG001|Participant Flow|Elagolix 150 mg|Participants received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.
10948057|NCT00797225|FG002|Participant Flow|Elagolix 250 mg|Participants received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
10948058|NCT00797225|FG003|Participant Flow|Leuprorelin|Participants received placebo tablets once a day and leuprorelin acetate 1-month depot 3.75 mg intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.
10948059|NCT00797225|FG004|Participant Flow|Placebo / Elagolix 150 mg|Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.
10948060|NCT00797225|FG005|Participant Flow|Placebo / Elagolix 250 mg|Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
10948061|NCT00797225|FG006|Participant Flow|Leuprorelin / Elagolix 150 mg|Participants initially randomized to leuprorelin acetate were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.
10948062|NCT00797225|FG007|Participant Flow|Leuprorelin / Elagolix 250 mg|Participants initially randomized to leuprorelin acetate were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
11177915|NCT02044796|FG001|Participant Flow|Newly Diagnosed Group Mitoxantrone Hydrochloride 14 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
10948063|NCT00797225|OG000|Outcome|Placebo|Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.
10948064|NCT00797225|OG001|Outcome|Elagolix 150 mg|Participants received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.
10948065|NCT00797225|OG002|Outcome|Elagolix 250 mg|Participants received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
10948066|NCT00797225|OG003|Outcome|Leuprorelin|Participants received placebo tablets once a day and leuprorelin acetate 1-month depot 3.75 mg intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.
10948067|NCT00797225|OG000|Outcome|Elagolix 150 mg|Participants received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.
11177916|NCT02044796|FG002|Participant Flow|Newly Diagnosed Group Mitoxantrone Hydrochloride 16 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177917|NCT02044796|FG003|Participant Flow|Newly Diagnosed Group Mitoxantrone Hydrochloride 18mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11192213|NCT02137837|BG000|Baseline|Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Placebo - Anastrozole~Placebo - Everolimus"
10948068|NCT00797225|OG001|Outcome|Elagolix 250 mg|Participants received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
10948069|NCT00797225|OG002|Outcome|Placebo / Elagolix 150 mg|Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.
10948070|NCT00797225|OG003|Outcome|Placebo / Elagolix 250 mg|Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
10948071|NCT00797225|OG004|Outcome|Leuprorelin / Elagolix 150 mg|Participants initially randomized to leuprorelin acetate were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.
10948072|NCT00797225|OG005|Outcome|Leuprorelin / Elagolix 250 mg|Participants initially randomized to leuprorelin acetate were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
10948073|NCT00797225|EG000|Reported Event|Placebo|Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks.
10948074|NCT00797225|EG001|Reported Event|Elagolix 150 mg|"Participants initially randomized to elagolix 150 mg received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.~Participants initially randomized to placebo or leuprorelin were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks."
10948075|NCT00797225|EG002|Reported Event|Elagolix 250 mg|"Participants initially randomized to elagolix 250 mg received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.~Participants initially randomized to placebo or leuprorelin were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks."
10948076|NCT00797225|EG003|Reported Event|Leuprorelin Acetate|Participants received placebo tablets once a day and leuprorelin acetate 1-month depot 3.75 mg intramuscular injection once a month for 12 weeks.
10948077|NCT00797277|BG000|Baseline|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
10948078|NCT00797277|BG001|Baseline|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
10948079|NCT00797277|BG002|Baseline|Total|Total of all reporting groups
10948080|NCT00797277|FG000|Participant Flow|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
10948081|NCT00797277|FG001|Participant Flow|2. IM Haloperidol Plus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
10948082|NCT00797277|OG000|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
10948083|NCT00797277|OG001|Outcome|2. IM Haloperidol Plus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
10948084|NCT00797277|OG001|Outcome|2. IM Haloperidol Pus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
10948085|NCT00797277|EG000|Reported Event|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
10948086|NCT00797277|EG001|Reported Event|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
10948087|NCT00797316|BG000|Baseline|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
10948088|NCT00797316|BG001|Baseline|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
10948089|NCT00797316|BG002|Baseline|Total|Total of all reporting groups
10948090|NCT00797316|FG000|Participant Flow|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
10948091|NCT00797316|FG001|Participant Flow|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
10948092|NCT00797316|OG000|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
10948093|NCT00797316|OG001|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
10948094|NCT00797316|EG000|Reported Event|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
10948095|NCT00797316|EG001|Reported Event|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
10948096|NCT00797459|BG000|Baseline|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
10948097|NCT00797459|FG000|Participant Flow|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
10948098|NCT00797459|OG000|Outcome|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
10948099|NCT00797459|OG001|Outcome|Restylane-L|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
10948100|NCT00797459|OG000|Outcome|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
10948101|NCT00797459|OG001|Outcome|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
10948102|NCT00797459|EG000|Reported Event|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
10948103|NCT00797459|EG001|Reported Event|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
10948104|NCT00797511|BG000|Baseline|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
10948105|NCT00797511|FG000|Participant Flow|ADACEL POLIO Vaccine Study Group|Participants received one dose of TdcP-IPV vaccine (ADACEL Polio) on Day 0.
10948106|NCT00797511|OG000|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
10948107|NCT00797511|OG000|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
10948108|NCT00797511|EG000|Reported Event|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
10948109|NCT00797563|BG000|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
10948110|NCT00797563|FG000|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
10948111|NCT00797563|OG000|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
10948112|NCT00797563|EG000|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
10948113|NCT00797667|BG000|Baseline|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
10948114|NCT00797667|BG001|Baseline|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
10948115|NCT00797667|BG002|Baseline|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
10948116|NCT00797667|BG003|Baseline|Total|Total of all reporting groups
10948117|NCT00797667|FG000|Participant Flow|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
10948118|NCT00797667|FG001|Participant Flow|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
10948119|NCT00797667|FG002|Participant Flow|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
10948120|NCT00797667|OG000|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
10948121|NCT00797667|OG001|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
10948122|NCT00797667|OG002|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
10948123|NCT00797667|EG000|Reported Event|MK-0974 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
10948124|NCT00797667|EG001|Reported Event|MK-0974 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
10948125|NCT00797667|EG002|Reported Event|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
10948126|NCT00797732|BG000|Baseline|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
10948127|NCT00797732|BG001|Baseline|Sham Acupuncture|TBoth active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
10948128|NCT00797732|BG002|Baseline|Total|Total of all reporting groups
10948129|NCT00797732|FG000|Participant Flow|Active Acupuncture|The active intervention used a three-phase step-up protocol to gradually increase the body areas treated and needling intensity. Acupuncture needles (0.20x25mm) were inserted with a depth of 5-10 mm into predefined points based on a systematic literature review following the STRICTA guideline. Needles were stimulated to obtain the de qi sensation. An electroacupuncture (EA) device was connected at two acupoints. All needles remained in place for 30 minutes. The active acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. [Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261]
10948130|NCT00797732|FG001|Participant Flow|Sham Acupuncture|The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. [Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005; 86:2248-2255]
10948131|NCT00797732|FG002|Participant Flow|Screened Non-Randomized|Participants approached in the screening process but ultimately not randomized.
10948132|NCT00797732|OG000|Outcome|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
10948133|NCT00797732|OG001|Outcome|Sham Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
10948134|NCT00797732|EG000|Reported Event|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
10948135|NCT00797732|EG001|Reported Event|Sham Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
10948136|NCT00797797|BG000|Baseline|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
10948137|NCT00797797|BG001|Baseline|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
10948138|NCT00797797|BG002|Baseline|Total|Total of all reporting groups
10948139|NCT00797797|FG000|Participant Flow|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
10948140|NCT00797797|FG001|Participant Flow|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
10948141|NCT00797797|OG000|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
10948142|NCT00797797|OG001|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
10948143|NCT00797797|EG000|Reported Event|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
10948144|NCT00797797|EG001|Reported Event|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
10948145|NCT00797823|BG000|Baseline|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
10948146|NCT00797823|BG001|Baseline|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
11177918|NCT02044796|FG004|Participant Flow|Relapsed/Refractory Group Mitoxantrone Hydrochloride 12 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177919|NCT02044796|FG005|Participant Flow|Relapsed/Refractory Group Mitoxantrone Hydrochloride 14 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11341741|NCT03687684|OG005|Outcome|Chinese Cohort 3: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
10948147|NCT00797823|BG002|Baseline|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
10948148|NCT00797823|BG003|Baseline|Total|Total of all reporting groups
10948149|NCT00797823|FG000|Participant Flow|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
10948150|NCT00797823|FG001|Participant Flow|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
10948151|NCT00797823|FG002|Participant Flow|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
10948152|NCT00797823|OG000|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
10948153|NCT00797823|OG001|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
10948154|NCT00797823|EG000|Reported Event|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
10948155|NCT00797823|EG001|Reported Event|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
10948156|NCT00797823|EG002|Reported Event|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
10948157|NCT00797862|BG000|Baseline|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948158|NCT00797862|BG001|Baseline|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948159|NCT00797862|BG002|Baseline|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948160|NCT00797862|BG003|Baseline|Total|Total of all reporting groups
10948161|NCT00797862|FG000|Participant Flow|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948162|NCT00797862|FG001|Participant Flow|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948163|NCT00797862|FG002|Participant Flow|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948164|NCT00797862|OG000|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948165|NCT00797862|OG001|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948166|NCT00797862|OG002|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
11341742|NCT03687684|OG000|Outcome|Japanese Cohort 2: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10948167|NCT00797862|EG000|Reported Event|Aliskiren + Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948168|NCT00797862|EG001|Reported Event|Aliskiren|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948169|NCT00797862|EG002|Reported Event|Amlodipine|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
10948170|NCT00797966|BG000|Baseline|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948171|NCT00797966|BG001|Baseline|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
10948172|NCT00797966|BG002|Baseline|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948173|NCT00797966|BG003|Baseline|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948174|NCT00797966|BG004|Baseline|Total|Total of all reporting groups
10948175|NCT00797966|FG000|Participant Flow|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948176|NCT00797966|FG001|Participant Flow|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
11177920|NCT02044796|FG006|Participant Flow|Relapsed/Refractory Group Mitoxantrone Hydrochloride 16 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177921|NCT02044796|FG007|Participant Flow|Relapsed/Refractory Group Mitoxantrone Hydrochloride 18 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11192214|NCT02137837|BG001|Baseline|Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Everolimus~Placebo - Anastrozole"
11192215|NCT02137837|BG002|Baseline|Arm 3: Fulvestrant + Everolimus + Anastrozole|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Anastrozole~Everolimus"
10948177|NCT00797966|FG002|Participant Flow|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948178|NCT00797966|FG003|Participant Flow|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948179|NCT00797966|FG004|Participant Flow|Participants in Phase A|Participants entered Phase A (single-blind prospective treatment) during which participants had received single-blind placebo plus an open-label commercially available ADT for 8 weeks at maximally tolerated doses.
10948180|NCT00797966|FG005|Participant Flow|Participants in Phase A+|Based on the response at Week 8 (in Phase A), participants were either randomized to Phase B or continued single-blind treatment in Phase A+. Participants who met the criteria for a response at Week 8 were not to be randomized into Phase B but continued to receive single-blind placebo plus the maximum tolerated dose of ADT from Week 8 for an additional 6 weeks in Phase A+.
10948181|NCT00797966|OG000|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948182|NCT00797966|OG001|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948183|NCT00797966|OG002|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948184|NCT00797966|OG003|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948185|NCT00797966|OG003|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
10948186|NCT00797966|OG001|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
10948187|NCT00797966|EG000|Reported Event|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948188|NCT00797966|EG001|Reported Event|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948189|NCT00797966|EG002|Reported Event|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948190|NCT00797966|EG003|Reported Event|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
10948191|NCT00798018|BG000|Baseline|Air Alone|Only air was injected into the cuff, as the routine practice
10948192|NCT00798018|BG001|Baseline|Normal Saline|normal saline was used to inflate the cuff
10948193|NCT00798018|BG002|Baseline|Lidocaine|2% lidiocaine was used to inflate the cuff
10948194|NCT00798018|BG003|Baseline|Tetracaine|1% tetracaine was used to inflate the cuff
10948195|NCT00798018|BG004|Baseline|Total|Total of all reporting groups
10948196|NCT00798018|FG000|Participant Flow|Air Alone|Only air was injected into the cuff, as the routine practice
10948197|NCT00798018|FG001|Participant Flow|Normal Saline|normal saline was used to inflate the cuff
10948198|NCT00798018|FG002|Participant Flow|Lidocaine|2% lidiocaine was used to inflate the cuff
10948199|NCT00798018|FG003|Participant Flow|Tetracaine|1% tetracaine was used to inflate the cuff
10948200|NCT00798018|OG000|Outcome|Air Alone|Only air was injected into the cuff, as the routine practice
10948201|NCT00798018|OG001|Outcome|Normal Saline|normal saline was used to inflate the cuff
10948202|NCT00798018|OG002|Outcome|Lidocaine|2% lidiocaine was used to inflate the cuff
10948203|NCT00798018|OG003|Outcome|Tetracaine|1% tetracaine was used to inflate the cuff
10948204|NCT00798018|EG000|Reported Event|Air Alone|Only air was injected into the cuff, as the routine practice
10948205|NCT00798018|EG001|Reported Event|Normal Saline|normal saline was used to inflate the cuff
10948206|NCT00798018|EG002|Reported Event|Lidocaine|2% lidiocaine was used to inflate the cuff
10948207|NCT00798018|EG003|Reported Event|Tetracaine|1% tetracaine was used to inflate the cuff
10948208|NCT00798096|BG000|Baseline|Overall Study|1-fostamatinib 200mg, BID, Oral
10948209|NCT00798096|FG000|Participant Flow|Overall Study|1-fostamatinib 200mg, BID, Oral
10948210|NCT00798096|OG000|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
10948211|NCT00798096|EG000|Reported Event|Overall Study|1-fostamatinib 200mg, BID, Oral
10948212|NCT00798135|BG000|Baseline|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
10948213|NCT00798135|FG000|Participant Flow|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
10948214|NCT00798135|OG000|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
10948215|NCT00798135|EG000|Reported Event|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
10948216|NCT00798161|BG000|Baseline|Placebo|Patients treated with matching placebo
10948217|NCT00798161|BG001|Baseline|M500BID|Patients treated with Metformin 500mg BID
10948218|NCT00798161|BG002|Baseline|M1000BID|Patients treated with Metformin 1000mg BID
10948219|NCT00798161|BG003|Baseline|Lina5|Patients treated with Linagliptin 5mg OD
10948220|NCT00798161|BG004|Baseline|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
10948221|NCT00798161|BG005|Baseline|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
10948222|NCT00798161|BG006|Baseline|L2.5+M1000BID (Open Label)|Open label set: Linagliptin 2.5mg + Metformin 1000mg BID
10948223|NCT00798161|BG007|Baseline|Total|Total of all reporting groups
10948224|NCT00798161|FG000|Participant Flow|Placebo|Patients treated with matching placebo
10948225|NCT00798161|FG001|Participant Flow|M500 Twice Daily (BID)|Patients treated with Metformin 500 mg BID
10948226|NCT00798161|FG002|Participant Flow|M1000 BID|Patients treated with Metformin 1000 mg BID
10948227|NCT00798161|FG003|Participant Flow|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
10948228|NCT00798161|FG004|Participant Flow|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID
10948229|NCT00798161|FG005|Participant Flow|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID
10948230|NCT00798161|FG006|Participant Flow|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID
10948231|NCT00798161|OG000|Outcome|Placebo|Patients treated with matching placebo
10948232|NCT00798161|OG001|Outcome|M500BID|Patients treated with Metformin 500mg BID
10948233|NCT00798161|OG002|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
10948234|NCT00798161|OG003|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
11192216|NCT02137837|BG003|Baseline|Total|Total of all reporting groups
10948235|NCT00798161|OG004|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
10948236|NCT00798161|OG005|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
10948237|NCT00798161|OG000|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
10948238|NCT00798161|EG000|Reported Event|Placebo|Patients treated with matching placebo
10948239|NCT00798161|EG001|Reported Event|M500 BID|Patients treated with Metformin 500 mg BID
10948240|NCT00798161|EG002|Reported Event|M1000 BID|Patients treated with Metformin 1000 mg bis in die (BID)
10948241|NCT00798161|EG003|Reported Event|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
10948242|NCT00798161|EG004|Reported Event|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID)
10948243|NCT00798161|EG005|Reported Event|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
10948244|NCT00798161|EG006|Reported Event|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
10948245|NCT00798174|BG000|Baseline|Standard SVC Coil vs. Azygos Coil|"The DFT with the standard SVC coil vs. DFT with the azygos vein coil in place.~Azygos vein coil: Addition of an azygos vein defibrillation coil instead of a standard SVC coil."
10948246|NCT00798174|FG000|Participant Flow|Standard Configuration First|"st time period (approx. 0.5 hour): Defibrillation Threshold (DFT) testing was performed with standard configuration first. A maximum of three inductions of ventricular fibrillation (VF) with defibrillation were performed to establish a standard configuration threshold. There were at least 5 minutes between defibrillation tests, so the standard configuration period was approximately 0.5 hour.~nd time period: The azygos coil was then added for the second phase.~(Azygos vein coil: Addition of an azygos vein defibrillation coil in place of a standard superior vena cava (SVC) coil.)"
10948247|NCT00798174|FG001|Participant Flow|Azygos Coil Configuration First|"st time period (approx 0.5 hr): DFT testing was performed with an azygos coil in place first. A maximum of three inductions of VF with defibrillation were performed to establish a standard configuration threshold. There were at least 5 minutes between defibrillation tests, so the standard configuration period was approximately 0.5 hour.~nd time period (approx 0.5 hour): The azygos coil was then excluded from the shocking configuration and replaced by the standard SVC coil configuration for the second phase."
10948248|NCT00798174|OG000|Outcome|Standard Configuration vs. Azygos Coil|"The DFT with the standard SVC coil vs. DFT with the azygos coil. In this crossover study, each patient serves and own control, with defibrillation testing performed with and with the azygos coil~Standard configuration vs. azygos coil: Addition of an azygos vein defibrillation coil instead of a standard SVC coil."
10948249|NCT00798174|EG000|Reported Event|Standard Configuration vs. Azygos Coil Configuation|"The DFT with the standard SVC coil vs. DFT with the azygos vein coil in place.~Since all subjects underwent attempted azygos vein implantation, the implantation procedure was the same for the arm in which the standard configuration was tested first and the arm in which the azygos configuration was tested. first. Therefore, the two arms (Standard configuration tested first and Azygos configuration tested first) were combined for the purpose of adverse events."
10948250|NCT00798304|BG000|Baseline|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
10948251|NCT00798304|BG001|Baseline|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
10948252|NCT00798304|BG002|Baseline|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
10948253|NCT00798304|BG003|Baseline|Total|Total of all reporting groups
10948254|NCT00798304|FG000|Participant Flow|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
10948255|NCT00798304|FG001|Participant Flow|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
10948256|NCT00798304|FG002|Participant Flow|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
10948257|NCT00798304|OG000|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
10948258|NCT00798304|OG001|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
10948259|NCT00798304|OG002|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
10948260|NCT00798304|EG000|Reported Event|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
10948261|NCT00798304|EG001|Reported Event|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
10948262|NCT00798304|EG002|Reported Event|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
10948263|NCT00798317|BG000|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
10948264|NCT00798317|BG001|Baseline|Placebo|Intravitreal injection of placebo
10948265|NCT00798317|BG002|Baseline|Total|Total of all reporting groups
10948266|NCT00798317|FG000|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
10948267|NCT00798317|FG001|Participant Flow|Placebo|Intravitreal injection of placebo
10948268|NCT00798317|OG000|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
10948269|NCT00798317|OG001|Outcome|Placebo|Intravitreal injection of placebo
10948270|NCT00798317|EG000|Reported Event|Ocriplasmin 125ug|125ug ocriplasmin intravitreal injection
10948271|NCT00798317|EG001|Reported Event|Placebo|Intravitreal injection of placebo
10948272|NCT00798369|BG000|Baseline|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
11341743|NCT03687684|OG001|Outcome|Japanese Cohort 4: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10948273|NCT00798369|BG001|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948274|NCT00798369|BG002|Baseline|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948275|NCT00798369|BG003|Baseline|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948276|NCT00798369|BG004|Baseline|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948277|NCT00798369|BG005|Baseline|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
10948278|NCT00798369|BG006|Baseline|Total|Total of all reporting groups
10948279|NCT00798369|FG000|Participant Flow|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948280|NCT00798369|FG001|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948281|NCT00798369|FG002|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948282|NCT00798369|FG003|Participant Flow|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948283|NCT00798369|FG004|Participant Flow|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948284|NCT00798369|FG005|Participant Flow|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
10948285|NCT00798369|OG000|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948286|NCT00798369|OG001|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948287|NCT00798369|OG002|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948288|NCT00798369|OG003|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948289|NCT00798369|OG004|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948290|NCT00798369|OG005|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
10948291|NCT00798369|OG000|Outcome|Linear Model|The linear model was the best-fitting model out of the 4 selected models (Emax, Logistic, Linear in Log-dose, Linear)with lowest Akaike Information Criterion (AIC).
11341744|NCT03687684|OG002|Outcome|Japanese Cohort 5: TAK-831 50 mg|TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10948292|NCT00798369|EG000|Reported Event|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948293|NCT00798369|EG001|Reported Event|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948294|NCT00798369|EG002|Reported Event|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948295|NCT00798369|EG003|Reported Event|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948296|NCT00798369|EG004|Reported Event|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
10948297|NCT00798369|EG005|Reported Event|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
10948298|NCT00798434|BG000|Baseline|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
10948299|NCT00798434|BG001|Baseline|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
10948300|NCT00798434|BG002|Baseline|Total|Total of all reporting groups
10948301|NCT00798434|FG000|Participant Flow|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 milligrams (mg) once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
10948302|NCT00798434|FG001|Participant Flow|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
10948303|NCT00798434|OG000|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
10948304|NCT00798434|OG001|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
10948305|NCT00798434|OG000|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
10948306|NCT00798434|OG001|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
10948307|NCT00798434|OG001|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
10948308|NCT00798434|EG000|Reported Event|Placebo Double-Blind|Participants received matched placebo once daily from baseline to Week 12 (double-blinded)
10948309|NCT00798434|EG001|Reported Event|Fesoterodine Double-Blind|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded)
10948310|NCT00798434|EG002|Reported Event|Festerodine/Fesoterodine Open-Label|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). Serious adverse events (SAEs) and non-serious adverse events (AEs) reported reported for these participants only during the open-label phase.
10948311|NCT00798434|EG003|Reported Event|Placebo/Fesoterodine Open-label|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). SAEs and non-serious AEs reported for these participants only during the open-label phase.
11192217|NCT02137837|FG000|Participant Flow|Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Placebo - Anastrozole~Placebo - Everolimus"
10948312|NCT00798486|BG000|Baseline|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
10948313|NCT00798486|FG000|Participant Flow|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
10948314|NCT00798486|OG000|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
10948315|NCT00798486|EG000|Reported Event|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
10948316|NCT00798577|BG000|Baseline|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
10948317|NCT00798577|BG001|Baseline|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
10948318|NCT00798577|BG002|Baseline|Total|Total of all reporting groups
10948319|NCT00798577|FG000|Participant Flow|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
10948320|NCT00798577|FG001|Participant Flow|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
10948321|NCT00798577|OG000|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
10948322|NCT00798577|OG001|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
10948323|NCT00798577|EG000|Reported Event|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
10948324|NCT00798577|EG001|Reported Event|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
10948325|NCT00798603|BG000|Baseline|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
10948326|NCT00798603|FG000|Participant Flow|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
10948327|NCT00798603|OG000|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
10948328|NCT00798603|EG000|Reported Event|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
10948329|NCT00798655|BG000|Baseline|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
10948330|NCT00798655|FG000|Participant Flow|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
10948331|NCT00798655|OG000|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
10948332|NCT00798655|EG000|Reported Event|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
10948333|NCT00798694|BG000|Baseline|Group 1 (New to Meds)|"Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948334|NCT00798694|BG001|Baseline|Group 2 (Currently on Xalatan)|"Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948335|NCT00798694|BG002|Baseline|Total|Total of all reporting groups
10948336|NCT00798694|FG000|Participant Flow|Group 1 (New to Meds)|"Naive to glaucoma therapy medical or surgical. These patients have never used eye drops to lower eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948337|NCT00798694|FG001|Participant Flow|Group 2 (Currently on Xalatan)|"Patients currently on Xalatan at least one month. These patients have been using Xalatan at least one month to lower their eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948338|NCT00798694|OG000|Outcome|New to Meds|"Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime~A geometric mean ratio of 1 indicates equivalence of the two geometric means."
10948339|NCT00798694|OG001|Outcome|Currently on Xalatan|"Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948340|NCT00798694|OG000|Outcome|Group 1 (New to Meds)|"Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948341|NCT00798694|OG001|Outcome|Group 2 (Currently on Xalatan)|"Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948342|NCT00798694|OG000|Outcome|Group 1 Xalatan|28 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)
10948343|NCT00798694|OG001|Outcome|Group 1 Travatan Z|28 patients - Eye using Travatan Z (travoprost with SofZia)
10948344|NCT00798694|OG002|Outcome|Group 2 Xalatan|27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)
10948345|NCT00798694|OG003|Outcome|Group 2 Travatan Z|27 patients - Eye using Travatan Z (travoprost with SofZia)
10948346|NCT00798694|EG000|Reported Event|New to Meds|"Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948347|NCT00798694|EG001|Reported Event|Currently on Xalatan|"Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.~Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime~Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime"
10948348|NCT00798707|BG000|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
10948349|NCT00798707|BG001|Baseline|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
10948350|NCT00798707|BG002|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
10948351|NCT00798707|BG003|Baseline|Total|Total of all reporting groups
10948352|NCT00798707|FG000|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
10948353|NCT00798707|FG001|Participant Flow|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
10948354|NCT00798707|FG002|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
10948355|NCT00798707|OG000|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
10948356|NCT00798707|OG001|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
10948357|NCT00798707|OG002|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
10948358|NCT00798707|EG000|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
10948359|NCT00798707|EG001|Reported Event|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
10948360|NCT00798707|EG002|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
10948361|NCT00798720|BG000|Baseline|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
10948362|NCT00798720|FG000|Participant Flow|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
10948363|NCT00798720|OG000|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
10948364|NCT00798720|EG000|Reported Event|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
10948365|NCT00798759|BG000|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
10948366|NCT00798759|BG001|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
10948367|NCT00798759|BG002|Baseline|Total|Total of all reporting groups
10948368|NCT00798759|FG000|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
10948369|NCT00798759|FG001|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
10948370|NCT00798759|OG000|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
10948371|NCT00798759|OG001|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
10948372|NCT00798759|EG000|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
10948373|NCT00798759|EG001|Reported Event|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
10948374|NCT00798889|BG000|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.
10948375|NCT00798889|FG000|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.
10948376|NCT00798889|OG000|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.
10948377|NCT00798889|EG000|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.
10948378|NCT00798967|BG000|Baseline|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
10948379|NCT00798967|BG001|Baseline|Placebo|Matching sc dose of placebo to teduglutide
10948380|NCT00798967|BG002|Baseline|Total|Total of all reporting groups
10948381|NCT00798967|FG000|Participant Flow|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
10948382|NCT00798967|FG001|Participant Flow|Placebo|Matching sc dose of placebo to teduglutide
10948383|NCT00798967|OG000|Outcome|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
10948384|NCT00798967|OG001|Outcome|Placebo|Matching sc dose of placebo to teduglutide
10948385|NCT00798967|OG000|Outcome|Teduglutide|0.05 mg/kg/day sc dose of teduglutide
10948386|NCT00798967|EG000|Reported Event|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
10948387|NCT00798967|EG001|Reported Event|Placebo|Matching sc dose of placebo to teduglutide
10948388|NCT00799227|BG000|Baseline|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
10948389|NCT00799227|FG000|Participant Flow|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
10948390|NCT00799227|OG000|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
10948391|NCT00799227|EG000|Reported Event|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
10948392|NCT00799383|BG000|Baseline|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
10948393|NCT00799383|BG001|Baseline|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
10948394|NCT00799383|BG002|Baseline|Total|Total of all reporting groups
10948395|NCT00799383|FG000|Participant Flow|Calcium+VitD|Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
10948396|NCT00799383|FG001|Participant Flow|Placebo|Placebo administered in similarly looking capsules.
10948397|NCT00799383|OG000|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
10948398|NCT00799383|OG001|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
10948399|NCT00799383|EG000|Reported Event|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
10948400|NCT00799383|EG001|Reported Event|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
10948401|NCT00799409|BG000|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
10948402|NCT00799409|BG001|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
10948403|NCT00799409|BG002|Baseline|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
10948404|NCT00799409|BG003|Baseline|Total|Total of all reporting groups
10948405|NCT00799409|FG000|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
10948406|NCT00799409|FG001|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
11192218|NCT02137837|FG001|Participant Flow|Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Everolimus~Placebo - Anastrozole"
11192219|NCT02137837|FG002|Participant Flow|Arm 3: Fulvestrant + Everolimus + Anastrozole|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Anastrozole~Everolimus"
10948407|NCT00799409|FG002|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
10948408|NCT00799409|OG000|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
10948409|NCT00799409|OG001|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
10948410|NCT00799409|OG002|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
10948411|NCT00799409|EG000|Reported Event|Placebo|Placebo was received during the lab school day
10948412|NCT00799409|EG001|Reported Event|Concerta|Concerta was received during the lab school day
10948413|NCT00799409|EG002|Reported Event|Open Label/Non-Lab Day CONCERTA|Dose adjustment period and double blind period other than lab school day
10948414|NCT00799422|BG000|Baseline|Overall|Baseline characteristics are presented for all participants completing all three treatment sequences.
10948415|NCT00799422|FG000|Participant Flow|ReNu / Complete / Clear Care|ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each
10948416|NCT00799422|FG001|Participant Flow|Complete / Clear Care / ReNu|Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each
10948417|NCT00799422|FG002|Participant Flow|Clear Care / ReNu / Complete|Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each
10948418|NCT00799422|FG003|Participant Flow|ReNu / Clear Care / Complete|ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each
10948419|NCT00799422|FG004|Participant Flow|Complete / ReNu / Clear Care|Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each
10948420|NCT00799422|FG005|Participant Flow|Clear Care / Complete / ReNu|Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each
10948421|NCT00799422|OG000|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
10948422|NCT00799422|OG001|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
10948423|NCT00799422|OG002|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
10948424|NCT00799422|EG000|Reported Event|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
10948425|NCT00799422|EG001|Reported Event|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
10948426|NCT00799422|EG002|Reported Event|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
10948427|NCT00799435|BG000|Baseline|Usual Care|Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
10948428|NCT00799435|BG001|Baseline|Exenatide|"Participants will receive exenatide for 12 weeks.~Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks"
10948429|NCT00799435|BG002|Baseline|Total|Total of all reporting groups
10948430|NCT00799435|FG000|Participant Flow|Control Group|Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
10948431|NCT00799435|FG001|Participant Flow|Exenatide Group|"Participants will receive exenatide for 12 weeks.~Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks"
10948432|NCT00799435|OG000|Outcome|Usual Care|Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
10948433|NCT00799435|OG001|Outcome|Exenatide|"Participants will receive exenatide for 12 weeks.~Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks"
10948434|NCT00799435|EG000|Reported Event|Standard Care|Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
10948435|NCT00799435|EG001|Reported Event|Exenatide|"Participants will receive exenatide for 12 weeks.~Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks"
10948436|NCT00799474|BG000|Baseline|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
10948437|NCT00799474|FG000|Participant Flow|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
10948438|NCT00799474|OG000|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
10948439|NCT00799474|EG000|Reported Event|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
10948440|NCT00799487|BG000|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
10948441|NCT00799487|BG001|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and Concerta lab school day 2
10948442|NCT00799487|BG002|Baseline|Concerta/Placebo|Children randomized to receive Concerta at lab school day 1 and Placebo at lab school day 2
10948443|NCT00799487|BG003|Baseline|Total|Total of all reporting groups
10948444|NCT00799487|FG000|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
10948445|NCT00799487|FG001|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
10948446|NCT00799487|FG002|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
10948447|NCT00799487|OG000|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
10948448|NCT00799487|OG001|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
10948449|NCT00799487|OG002|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
10948450|NCT00799487|OG001|Outcome|Placebo|Chidren randomized to receive Placebo at lab school day 1 or lab school day 2
10948451|NCT00799487|OG001|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or at lab school day 2
10948452|NCT00799487|OG002|Outcome|Concerta|Chilfdren randomized to receive Concerta at lab school day 1 or lab school day 2
10948453|NCT00799487|EG000|Reported Event|Placebo|Placebo was received during the lab school day
10948454|NCT00799487|EG001|Reported Event|Concerta|Concerta was received during the lab school day
10948455|NCT00799487|EG002|Reported Event|Open Label|dose adjustment period and double blind period other than lab school day
10948456|NCT00799578|BG000|Baseline|Cystagon-EC|
10948457|NCT00799578|FG000|Participant Flow|Cystagon-EC|
10948458|NCT00799578|OG000|Outcome|Number of Improved Subjects|
10948459|NCT00799578|EG000|Reported Event|Number of Improved Subjects|
11341745|NCT03687684|OG003|Outcome|Chinese Cohort 3: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
11341746|NCT03687684|EG000|Reported Event|Japanese Cohort 1: Placebo|TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
10948460|NCT00799591|BG000|Baseline|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
10948461|NCT00799591|FG000|Participant Flow|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
10948462|NCT00799591|OG000|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
10948463|NCT00799591|EG000|Reported Event|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
10948464|NCT00799604|BG000|Baseline|Cohort 1: Clevidipine 250 μg (0.5 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
10948465|NCT00799604|BG001|Baseline|Cohort 2: Clevidipine 500 μg (1.0 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which Clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
10948466|NCT00799604|BG002|Baseline|Cohort 3: Clevidipine 125 μg ( mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
10948467|NCT00799604|BG003|Baseline|Total|Total of all reporting groups
10948468|NCT00799604|FG000|Participant Flow|Planned Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Five participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 and one participant who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 250 μg during Treatment Period 2 in this cohort.
10948469|NCT00799604|FG001|Participant Flow|Planned Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Six participants who received a Bolus 1 dose of 500 μg and six participants who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 500 μg during Treatment Period 2 in this cohort.
10948470|NCT00799604|FG002|Participant Flow|Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Three participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 received a Bolus 2 dose of 125 μg during Treatment Period 2 in this cohort.
10948471|NCT00799604|OG000|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
10948472|NCT00799604|OG001|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
10948473|NCT00799604|OG002|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
10948474|NCT00799604|OG002|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
10948475|NCT00799604|OG002|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
11341747|NCT03687684|EG001|Reported Event|Japanese Cohort 1: TAK-831 100 mg|TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
11341748|NCT03687684|EG002|Reported Event|Japanese Cohort 1: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
11341749|NCT03687684|EG003|Reported Event|Japanese Cohort 2, 4 and 5: Pooled Placebo|TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341750|NCT03687684|EG004|Reported Event|Japanese Cohort 2: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10948476|NCT00799604|EG000|Reported Event|All Participants Across All Cohorts and Treatment Periods|Study participants were sequentially assigned one of three cohorts to receive either a 250 μg, 500 μg or 125 μg bolus dose of clevidipine during Treatment Period 1 prior to induction of general anesthesia (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds). At the discretion of the investigator, a second bolus could be administered during Treatment Period 2 after induction of general anesthesia (Bolus 2 - with anesthesia) at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1.
10948477|NCT00799617|BG000|Baseline|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
10948478|NCT00799617|BG001|Baseline|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
11177922|NCT02044796|FG008|Participant Flow|Phase 2 Newly Diagnosed Group 18 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
10948479|NCT00799617|BG002|Baseline|Total|Total of all reporting groups
11177923|NCT02044796|FG009|Participant Flow|Phase 2 Relapsed/Refractory Group 16 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177924|NCT02044796|OG000|Outcome|Newly Diagnosed Group|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177925|NCT02044796|OG001|Outcome|Relapsed/Refractory Group|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177926|NCT02044796|OG001|Outcome|Relapsed/Refractory|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11341751|NCT03687684|EG005|Reported Event|Japanese Cohort 4: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10948480|NCT00799617|FG000|Participant Flow|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
10948481|NCT00799617|FG001|Participant Flow|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
10948482|NCT00799617|OG000|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
10948483|NCT00799617|OG001|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
10948484|NCT00799617|EG000|Reported Event|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
10948485|NCT00799617|EG001|Reported Event|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
10948486|NCT00799643|BG000|Baseline|Placebo|Placebo for salsalate, orally, divided dosing
10948487|NCT00799643|BG001|Baseline|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
10948488|NCT00799643|BG002|Baseline|Total|Total of all reporting groups
10948489|NCT00799643|FG000|Participant Flow|Placebo|Placebo for salsalate, orally, divided dosing
10948490|NCT00799643|FG001|Participant Flow|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
10948491|NCT00799643|OG000|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
10948492|NCT00799643|OG001|Outcome|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
10948493|NCT00799643|OG001|Outcome|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
10948494|NCT00799643|EG000|Reported Event|Placebo|Placebo for salsalate, orally, divided dosing
10948495|NCT00799643|EG001|Reported Event|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
10948496|NCT00799708|BG000|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
10948497|NCT00799708|BG001|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
10948498|NCT00799708|BG002|Baseline|Placebo|Placebo capsule once daily for 7 days.
10948499|NCT00799708|BG003|Baseline|Total|Total of all reporting groups
10948500|NCT00799708|FG000|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
10948501|NCT00799708|FG001|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
11192220|NCT02137837|OG000|Outcome|Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)~Fulvestrant~Placebo - Anastrozole~Placebo - Everolimus"
11341752|NCT03687684|EG006|Reported Event|Japanese Cohort 5: TAK-831 50 mg|TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
10948502|NCT00799708|FG002|Participant Flow|Placebo|Placebo capsule once daily for 7 days.
10948503|NCT00799708|OG000|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
10948504|NCT00799708|OG001|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
10948505|NCT00799708|OG002|Outcome|Placebo|Placebo capsule once daily for 7 days.
10948506|NCT00799708|OG000|Outcome|17β-estradiol 2.0 Milligrams|
10948507|NCT00799708|OG001|Outcome|Placebo|
10948508|NCT00799708|EG000|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
10948509|NCT00799708|EG001|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
10948510|NCT00799708|EG002|Reported Event|Placebo|Placebo capsule once daily for 7 days.
10948511|NCT00799812|BG000|Baseline|All Study Participants|All Participants Who Completed Evaluations
10948512|NCT00799812|FG000|Participant Flow|All Study Participants|Study Participants that were treated
10948513|NCT00799812|OG000|Outcome|CHG Swabstick (3 @ Once)|"Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time~CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).: 3 swabsticks topically applied at the same time to intact skin"
10948514|NCT00799812|OG001|Outcome|CHG Swabstick Sequential|"Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially~CHG 2% w/v & IPA 70% v/v swab applied sequentially: Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin."
10948515|NCT00799812|OG002|Outcome|Hibiclens|"Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base~Aqueous CHG 4% w/v applied according to mfr's directions: Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated."
10948516|NCT00799812|OG003|Outcome|Sterile Water Swab (3 @ Once)|"Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.~Sterile swabstick with sterile water (3 @ once): 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time."
10948517|NCT00799812|OG004|Outcome|Sterile Water Swabstick (Sequential)|"Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.~Sterile swabstick with sterile water (one-at-a-time): Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time."
10948518|NCT00799812|EG000|Reported Event|CHG Swabstick (3 @ Once)|"Chlorhexidine gluconate (CHG) 2% CHG/isopropyl alcohol (IPA) 70%-3 swabsticks applied @ same time~CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once): 3 swabsticks topically applied at the same time to intact skin"
10948519|NCT00799812|EG001|Reported Event|CHG Swabstick Sequential|"Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v--3 swabsticks applied sequentially~CHG 2% w/v & IPA 70% v/v swabstick: 3 swabsticks applied sequentially to intact skin."
10948520|NCT00799812|EG002|Reported Event|Hibiclens|"Chlorhexidine gluconate 4% w/v in an aqueous base~Aqueous CHG 4% w/v applied according to manufacturer's directions: Step 1) 5 mL of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated."
10948521|NCT00799812|EG003|Reported Event|Sterile Water Swab (3 @ Once)|"Sterile swabstick wetted with sterile deionized water--3 swabsticks applied at the same time.~Sterile swabstick with sterile deionized water (3 @ once): 3 swabsticks wetted with sterile water topically applied to intact skin at the same time."
10948522|NCT00799812|EG004|Reported Event|Sterile Water Swabstick (Sequential)|"Sterile swabstick wetted with sterile deionized water--3 swabsticks applied sequentially.~Sterile swabstick with sterile deionized water (sequentially): swabsticks wetted with sterile water topically applied to intact skin sequentially."
10948523|NCT00799825|BG000|Baseline|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
10948524|NCT00799825|FG000|Participant Flow|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
10948525|NCT00799825|OG000|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
10948526|NCT00799825|EG000|Reported Event|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
10948527|NCT00799903|BG000|Baseline|Placebo|Participants were randomized to receive matching placebo once daily.
11177927|NCT02044796|OG000|Outcome|Phase 2 Newly Diagnosed Group 18 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11192221|NCT02137837|OG001|Outcome|Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)~Fulvestrant~Everolimus~Placebo - Anastrozole"
10948528|NCT00799903|BG001|Baseline|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
10948529|NCT00799903|BG002|Baseline|Total|Total of all reporting groups
10948530|NCT00799903|FG000|Participant Flow|Placebo|Participants were randomized to receive matching placebo once daily.
10948531|NCT00799903|FG001|Participant Flow|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
10948532|NCT00799903|OG000|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
10948533|NCT00799903|OG001|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
10948534|NCT00799903|EG000|Reported Event|Placebo|Participants were randomized to receive matching placebo once daily.
10948535|NCT00799903|EG001|Reported Event|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
10948536|NCT00799981|BG000|Baseline|Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order|A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 6 arms with the following order of catheters used: AABB ABAB ABBA BAAB BABA BBAA BBAA
10948537|NCT00799981|FG000|Participant Flow|AABB|"7 cm then 7 cm then 10 cm then 10 cm~B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm~Four catheterizations, two with each product in a randomized order."
10948538|NCT00799981|FG001|Participant Flow|ABAB|"7 cm then 10 cm then 7 cm then 10 cm~B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm~Four catheterizations, two with each product in a randomized order."
10948539|NCT00799981|FG002|Participant Flow|ABBA|"7 cm then 10 cm then 10 cm then 7 cm~B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm~Four catheterizations, two with each product in a randomized order."
10948540|NCT00799981|FG003|Participant Flow|BAAB|"10 cm then 7 cm then 7 cm then 10 cm~B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm~Four catheterizations, two with each product in a randomized order."
10948541|NCT00799981|FG004|Participant Flow|BABA|"10 cm then 7 cm then 10 cm then 7 cm~B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm~Four catheterizations, two with each product in a randomized order."
10948542|NCT00799981|FG005|Participant Flow|BBAA|"10 cm then 10 cm then 7 cm then 7 cm~B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm~Four catheterizations, two with each product in a randomized order."
10948543|NCT00799981|OG000|Outcome|7 cm|"All study participants were catheterizised with both catheters twice in a randomized order.~Every subject is its' own control."
10948544|NCT00799981|OG001|Outcome|10 cm|"All study participants were catheterizised with both catheters twice in a randomized order.~Every subject is its' own control."
10948545|NCT00799981|OG000|Outcome|7 cm|"Coloplast SpeediCath Compact catheter, 7 cm~Four catheterizations, two with each product in a randomized order."
10948546|NCT00799981|OG001|Outcome|10 cm|"Astra Tech POBE catheter, 10 cm~Four catheterizations, two with each product in a randomized order."
10948547|NCT00799981|OG000|Outcome|All Subjects|"All study participants were catheterizised with both catheters twice in a randomized order.~Every subject is its' own control. The results of the bladder scan for cathetersization with the 7 cm long catheter minus the 10 cm long catheter shows the difference in residual volume.."
10948548|NCT00799981|EG000|Reported Event|7 cm|Coloplast SpeediCath Compact catheter, 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
10948549|NCT00799981|EG001|Reported Event|10 cm|Astra Tech POBE catheter, 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
10948550|NCT00800176|BG000|Baseline|Placebo|"During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.~During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test."
10948551|NCT00800176|BG001|Baseline|RO4998452 2.5 mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
10948552|NCT00800176|BG002|Baseline|RO4998452 5mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
10948553|NCT00800176|BG003|Baseline|RO4998452 10mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
10948554|NCT00800176|BG004|Baseline|RO4998452 20mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
11177928|NCT02044796|OG001|Outcome|Phase 2 Relapsed/Refractory Group 16 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
10948555|NCT00800176|BG005|Baseline|RO4998452 40mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
10948556|NCT00800176|BG006|Baseline|Total|Total of all reporting groups
10948557|NCT00800176|FG000|Participant Flow|Placebo|"During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.~During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test."
10948558|NCT00800176|FG001|Participant Flow|RO4998452 2.5mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
10948559|NCT00800176|FG002|Participant Flow|RO4998452 5mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
10948560|NCT00800176|FG003|Participant Flow|RO4998452 10 mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
10948561|NCT00800176|FG004|Participant Flow|RO4998452 20mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
10948562|NCT00800176|FG005|Participant Flow|RO4998452 40mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
10948563|NCT00800176|OG000|Outcome|Placebo|"During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.~During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test."
10948564|NCT00800176|OG001|Outcome|RO4998452 2.5 mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
10948565|NCT00800176|OG002|Outcome|RO4998452 5mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
10948566|NCT00800176|OG003|Outcome|RO4998452 10mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
10948567|NCT00800176|OG004|Outcome|RO4998452 20mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
10948568|NCT00800176|OG005|Outcome|RO4998452 40mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
10948569|NCT00800176|EG000|Reported Event|Placebo|"During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.~During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test."
10948570|NCT00800176|EG001|Reported Event|RO4998452 2.5mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
10948571|NCT00800176|EG002|Reported Event|RO4998452 5mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
10948572|NCT00800176|EG003|Reported Event|RO4998452 10mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
10948573|NCT00800176|EG004|Reported Event|RO4998452 20mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
10948574|NCT00800176|EG005|Reported Event|RO4998452 40mg|During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
11177929|NCT02044796|OG000|Outcome|Phase 2 Relapsed/Refractory Group 16 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
10948575|NCT00800202|BG000|Baseline|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
10948576|NCT00800202|BG001|Baseline|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
10948577|NCT00800202|BG002|Baseline|Total|Total of all reporting groups
10948578|NCT00800202|FG000|Participant Flow|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 milligrams per square meter (mg/m^2) iv every 3 weeks for 6 cycles and carboplatin Area Under Curve (AUC) 6.0 milligrams per milliliter per minute (mg/mL/min) iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
10948579|NCT00800202|FG001|Participant Flow|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib150 milligrams per day (mg/day) administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
10948580|NCT00800202|OG000|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
10948581|NCT00800202|OG001|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
10948582|NCT00800202|EG000|Reported Event|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
10948583|NCT00800202|EG001|Reported Event|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
10948584|NCT00800254|BG000|Baseline|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
10948585|NCT00800254|BG001|Baseline|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
10948586|NCT00800254|BG002|Baseline|Total|Total of all reporting groups
10948587|NCT00800254|FG000|Participant Flow|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
10948588|NCT00800254|FG001|Participant Flow|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
10948589|NCT00800254|OG000|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
10948590|NCT00800254|OG001|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
10948591|NCT00800254|EG000|Reported Event|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
10948592|NCT00800254|EG001|Reported Event|Standard Rehabilitation Protocol|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
10948593|NCT00800345|BG000|Baseline|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
10948594|NCT00800345|FG000|Participant Flow|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
10948595|NCT00800345|OG000|Outcome|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
10948596|NCT00800345|EG000|Reported Event|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
10948597|NCT00800384|BG000|Baseline|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
10948598|NCT00800384|BG001|Baseline|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
10948599|NCT00800384|BG002|Baseline|Total|Total of all reporting groups
10948600|NCT00800384|FG000|Participant Flow|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
10948601|NCT00800384|FG001|Participant Flow|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
10948602|NCT00800384|OG000|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
10948603|NCT00800384|OG001|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
10948604|NCT00800384|OG001|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and ventricular fibrillation (VF) induction was performed followed by shock delivery to test shock efficacy at implant.
10948605|NCT00800384|EG000|Reported Event|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
10948606|NCT00800384|EG001|Reported Event|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
10948607|NCT00800436|BG000|Baseline|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
10948608|NCT00800436|BG001|Baseline|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
10948609|NCT00800436|BG002|Baseline|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
10948610|NCT00800436|BG003|Baseline|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
10948611|NCT00800436|BG004|Baseline|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
10948612|NCT00800436|BG005|Baseline|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
10948613|NCT00800436|BG006|Baseline|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
10948614|NCT00800436|BG007|Baseline|Total|Total of all reporting groups
10948615|NCT00800436|FG000|Participant Flow|Part 1: Cohort 1|Healthy male participants received Herceptin 6 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1.
10948616|NCT00800436|FG001|Participant Flow|Part 1: Cohort 2|Female participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
10948617|NCT00800436|FG002|Participant Flow|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg subcutaneously (SC) on Day 1.
10948618|NCT00800436|FG003|Participant Flow|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
10948619|NCT00800436|FG004|Participant Flow|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
10948620|NCT00800436|FG005|Participant Flow|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
10948621|NCT00800436|FG006|Participant Flow|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
10948622|NCT00800436|OG000|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
11177930|NCT02044796|EG000|Reported Event|Newly Diagnosed Group Mitoxantrone Hydrochloride 12 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177931|NCT02044796|EG001|Reported Event|Newly Diagnosed Group Mitoxantrone Hydrochloride 14 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11341753|NCT03687684|EG007|Reported Event|Chinese Cohort 3: Placebo|TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
10948623|NCT00800436|OG001|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
10948624|NCT00800436|OG002|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
10948625|NCT00800436|OG003|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
10948626|NCT00800436|OG004|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
10948627|NCT00800436|OG005|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
10948628|NCT00800436|OG006|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
10948629|NCT00800436|EG000|Reported Event|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
10948630|NCT00800436|EG001|Reported Event|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
10948631|NCT00800436|EG002|Reported Event|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
10948632|NCT00800436|EG003|Reported Event|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
10948633|NCT00800436|EG004|Reported Event|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
10948634|NCT00800436|EG005|Reported Event|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
10948635|NCT00800436|EG006|Reported Event|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
10948636|NCT00800540|BG000|Baseline|Overall|All enrolled
10948637|NCT00800540|FG000|Participant Flow|AZARGA/COMBIGAN|AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
10948638|NCT00800540|FG001|Participant Flow|COMBIGAN/AZARGA|COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
10948639|NCT00800540|OG000|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
10948640|NCT00800540|OG001|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
10948641|NCT00800540|EG000|Reported Event|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
10948642|NCT00800540|EG001|Reported Event|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
10948643|NCT00800683|BG000|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
10948644|NCT00800683|BG001|Baseline|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
10948645|NCT00800683|BG002|Baseline|Total|Total of all reporting groups
10948646|NCT00800683|FG000|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
10948647|NCT00800683|FG001|Participant Flow|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
10948648|NCT00800683|OG000|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
10948649|NCT00800683|OG001|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
10948650|NCT00800683|EG000|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
10948651|NCT00800683|EG001|Reported Event|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
10948652|NCT00800735|BG000|Baseline|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
10948653|NCT00800735|FG000|Participant Flow|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
10948654|NCT00800735|OG000|Outcome|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
10948655|NCT00800735|EG000|Reported Event|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
10948656|NCT00800839|BG000|Baseline|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
10948657|NCT00800839|FG000|Participant Flow|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
10948658|NCT00800839|OG000|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
10948659|NCT00800839|EG000|Reported Event|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
10948660|NCT00800865|BG000|Baseline|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
10948661|NCT00800865|BG001|Baseline|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
10948662|NCT00800865|BG002|Baseline|Total|Total of all reporting groups
11341754|NCT03687684|EG008|Reported Event|Chinese Cohort 3: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
10948663|NCT00800865|FG000|Participant Flow|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
10948664|NCT00800865|FG001|Participant Flow|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
10948665|NCT00800865|OG000|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
10948666|NCT00800865|OG001|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
10948667|NCT00800865|EG000|Reported Event|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
10948668|NCT00800865|EG001|Reported Event|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
10948669|NCT00800982|BG000|Baseline|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
10948670|NCT00800982|BG001|Baseline|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
10948671|NCT00800982|BG002|Baseline|Total|Total of all reporting groups
10948672|NCT00800982|FG000|Participant Flow|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No Ultraviolet B will be given. Sham Ultraviolet B will not be used because the subjects are not blinded because they often know they are receiving sham Ultraviolet B due to differences in light intensity and heat.
10948673|NCT00800982|FG001|Participant Flow|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. Narrow Band Ultraviolet B therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff."
10948674|NCT00800982|OG000|Outcome|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
10948675|NCT00800982|OG001|Outcome|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
10948676|NCT00800982|EG000|Reported Event|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
10948677|NCT00800982|EG001|Reported Event|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
11341755|NCT03687736|BG000|Baseline|AbobotulinumtoxinA|"Open-label~AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region"
10948678|NCT00801099|BG000|Baseline|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
10948679|NCT00801099|FG000|Participant Flow|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
10948680|NCT00801099|OG000|Outcome|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
10948681|NCT00801099|EG000|Reported Event|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
10948682|NCT00801138|BG000|Baseline|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
10948683|NCT00801138|BG001|Baseline|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
10948684|NCT00801138|BG002|Baseline|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
10948685|NCT00801138|BG003|Baseline|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
10948686|NCT00801138|BG004|Baseline|Total|Total of all reporting groups
10948687|NCT00801138|FG000|Participant Flow|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
10948688|NCT00801138|FG001|Participant Flow|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
10948689|NCT00801138|FG002|Participant Flow|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
11192222|NCT02137837|OG001|Outcome|Arm 3: Fulvestrant + Everolimus + Anastrozole|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)~Fulvestrant~Anastrozole~Everolimus"
10948690|NCT00801138|FG003|Participant Flow|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
10948691|NCT00801138|OG000|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
10948692|NCT00801138|OG001|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
10948693|NCT00801138|OG002|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
10948694|NCT00801138|OG003|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
10948695|NCT00801138|EG000|Reported Event|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
10948696|NCT00801138|EG001|Reported Event|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
10948697|NCT00801138|EG002|Reported Event|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
10948698|NCT00801138|EG003|Reported Event|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
10948699|NCT00801229|BG000|Baseline|Vyvanse|
10948700|NCT00801229|BG001|Baseline|Placebo|
10948701|NCT00801229|BG002|Baseline|Total|Total of all reporting groups
10948702|NCT00801229|FG000|Participant Flow|Vyvanse|
10948703|NCT00801229|FG001|Participant Flow|Placebo|
10948704|NCT00801229|OG000|Outcome|Vyvanse|
10948705|NCT00801229|OG001|Outcome|Placebo|
10948706|NCT00801229|EG000|Reported Event|Vyvanse|
10948707|NCT00801229|EG001|Reported Event|Placebo|
10948708|NCT00801242|BG000|Baseline|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
10948709|NCT00801242|FG000|Participant Flow|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
10948710|NCT00801242|OG000|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
10948711|NCT00801242|EG000|Reported Event|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.
10948712|NCT00801398|BG000|Baseline|Single Dose of Oxymorphone IR: 5mg Tablet|
10948713|NCT00801398|BG001|Baseline|Single Dose of Oxymorphone IR: 10mg Tablet|
10948714|NCT00801398|BG002|Baseline|Single Dose of Oxymorphone IR: 15mg Tablet|
10948715|NCT00801398|BG003|Baseline|Multiple Dose of Oxymorphone IR: 5mg Tablet|
10948716|NCT00801398|BG004|Baseline|Multiple Dose of Oxymorphone IR: 10mg Tablet|
10948717|NCT00801398|BG005|Baseline|Multiple Dose of Oxymorphone IR: 15mg Tablet|
10948718|NCT00801398|BG006|Baseline|Total|Total of all reporting groups
10948719|NCT00801398|FG000|Participant Flow|Single Dose of Oxymorphone IR: 5mg Tablet|
10948720|NCT00801398|FG001|Participant Flow|Single Dose of Oxymorphone IR: 10mg Tablet|
10948721|NCT00801398|FG002|Participant Flow|Single Dose of Oxymorphone IR: 15mg Tablet|
10948722|NCT00801398|FG003|Participant Flow|Multiple Dose of Oxymorphone: 5mg Tablet|
10948723|NCT00801398|FG004|Participant Flow|Multiple Dose of Oxymorphone IR: 10mg Tablet|
10948724|NCT00801398|FG005|Participant Flow|Multiple Dose of Oxymorphone IR: 15mg Tablet|
10948725|NCT00801398|OG000|Outcome|Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet|Change from Baseline
10948726|NCT00801398|OG001|Outcome|Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet|Change from Baseline
10948727|NCT00801398|OG002|Outcome|Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet|Change from Baseline
10948728|NCT00801398|OG003|Outcome|Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet|Change from Baseline
10948729|NCT00801398|OG004|Outcome|Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet|Change from Baseline
10948730|NCT00801398|OG005|Outcome|Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet|Change from Baseline
10948731|NCT00801398|OG000|Outcome|Single Dose of Oxymorphone IR: 5mg Tablet|Subjects With at Least One Rescue Medication
10948732|NCT00801398|OG001|Outcome|Single Dose of Oxymorphone IR: 10mg Tablet|Subjects With at Least One Rescue Medication
11177932|NCT02044796|EG002|Reported Event|Newly Diagnosed Group Mitoxantrone Hydrochloride 16 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
10948733|NCT00801398|OG002|Outcome|Single Dose of Oxymorphone IR: 15mg Tablet|Subjects With at Least One Rescue Medication
10948734|NCT00801398|OG003|Outcome|Multiple Dose of Oxymorphone: 5mg Tablet|Subjects With at Least One Rescue Medication
11177933|NCT02044796|EG003|Reported Event|Newly Diagnosed Group Mitoxantrone Hydrochloride 18 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11240759|NCT02481596|BG000|Baseline|REACH + FAMS|"Participants will receive FAMS components (monthly phone coaching and text messages supporting goal set in coaching, plus the option to invite a support person to receive text messages) for six months.~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions."
10948735|NCT00801398|OG004|Outcome|Multiple Dose of Oxymorphone IR: 10mg Tablet|Subjects With at Least One Rescue Medication
10948736|NCT00801398|OG005|Outcome|Multiple Dose of Oxymorphone IR: 15mg Tablet|Subjects With at Least One Rescue Medication
10948737|NCT00801398|OG000|Outcome|Single Dose of Oxymorphone IR: 5mg Tablet|
10948738|NCT00801398|OG001|Outcome|Single Dose of Oxymorphone IR: 10mg Tablet|
10948739|NCT00801398|OG002|Outcome|Single Dose of Oxymorphone IR: 15mg Tablet|
10948740|NCT00801398|OG003|Outcome|Single Dose of 6-OH-Oxymorphone: 5mg Tablet|
10948741|NCT00801398|OG004|Outcome|6-OH-Oxymorphone (ng/mL): 10mg|
10948742|NCT00801398|OG005|Outcome|6-OH-Oxymorphone (ng/mL): 15mg|
10948743|NCT00801398|OG004|Outcome|Single Dose of 6-OH-Oxymorphone: 10mg Tablet|
10948744|NCT00801398|OG005|Outcome|Single Dose 6-OH-Oxymorphone: 15mg Tablet|
10948745|NCT00801398|EG000|Reported Event|Single Dose of Oxymorphone IR: 5mg Tablet|
10948746|NCT00801398|EG001|Reported Event|Single Dose of Oxymorphone IR: 10mg Tablet|
10948747|NCT00801398|EG002|Reported Event|Single Dose of Oxymorphone IR: 15mg Tablet|
10948748|NCT00801398|EG003|Reported Event|Multiple Dose of Oxymorphone IR: 5mg Tablet|
10948749|NCT00801398|EG004|Reported Event|Multiple Dose of Oxymorphone IR: 10mg Tablet|
10948750|NCT00801398|EG005|Reported Event|Multiple Dose of Oxymorphone IR: 15mg Tablet|
10948751|NCT00801632|BG000|Baseline|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
10948752|NCT00801632|FG000|Participant Flow|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
10948753|NCT00801632|OG000|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
10948754|NCT00801632|EG000|Reported Event|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
10948755|NCT00801684|BG000|Baseline|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
10948756|NCT00801684|FG000|Participant Flow|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
10948757|NCT00801684|OG000|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
10948758|NCT00801684|OG001|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
10948759|NCT00801684|OG002|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
10948760|NCT00801684|OG003|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
10948761|NCT00801684|OG004|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
10948762|NCT00801684|OG000|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
10948763|NCT00801684|OG001|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
11341756|NCT03687736|FG000|Participant Flow|abobotulinumtoxinA|"open-label~AbobotulinumtoxinA: AbobotulinumtoxinA treatment in the glabellar region"
11341757|NCT03687736|OG000|Outcome|AbobotulinumtoxinA|"Open-label~AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region"
10948764|NCT00801684|OG002|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
10948765|NCT00801684|OG003|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
10948766|NCT00801684|EG000|Reported Event|Overall Study|
10948767|NCT00801684|EG001|Reported Event|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
10948768|NCT00801684|EG002|Reported Event|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
10948769|NCT00801684|EG003|Reported Event|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
10948770|NCT00801684|EG004|Reported Event|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
10948771|NCT00801684|EG005|Reported Event|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
10948772|NCT00801723|BG000|Baseline|2: Placebo|"One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.~Placebo Tablet: Placebo Tablet once daily."
10948773|NCT00801723|BG001|Baseline|1: Budesonide MMX® 6 mg|"One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.~Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily."
10948774|NCT00801723|BG002|Baseline|Total|Total of all reporting groups
10948775|NCT00801723|FG000|Participant Flow|2: Placebo|"One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.~Placebo Tablet: Placebo Tablet once daily."
10948776|NCT00801723|FG001|Participant Flow|1: Budesonide MMX® 6 mg|"One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.~Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily."
10948777|NCT00801723|OG000|Outcome|2: Placebo|"One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.~Placebo Tablet: Placebo Tablet once daily."
10948778|NCT00801723|OG001|Outcome|1: Budesonide MMX® 6 mg|"One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.~Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily."
10948779|NCT00801723|EG000|Reported Event|2: Placebo|"One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.~Placebo Tablet: Placebo Tablet once daily."
10948780|NCT00801723|EG001|Reported Event|1: Budesonide MMX® 6 mg|"One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.~Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily."
10948781|NCT00801801|BG000|Baseline|Metronomic Taxotere + Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
10948782|NCT00801801|FG000|Participant Flow|Metronomic Taxotere and Nexavar|"Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.~Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated after every 8 weeks. Treatment with metronomic chemotherapy and sorafenib will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with sorafenib will then continue until disease progression, intolerable toxicity or withdrawal of consent."
11177934|NCT02044796|EG004|Reported Event|Relapsed/Refractory Group Mitoxantrone Hydrochloride 12 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177935|NCT02044796|EG005|Reported Event|Relapsed/Refractory Group Mitoxantrone Hydrochloride 14 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177936|NCT02044796|EG006|Reported Event|Relapsed/Refractory Group Mitoxantrone Hydrochloride 16 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177937|NCT02044796|EG007|Reported Event|Relapsed/Refractory Group Mitoxantrone Hydrochloride 18 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
10948783|NCT00801801|OG000|Outcome|Metronomic Taxotere + Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
10948784|NCT00801801|OG000|Outcome|Metronomic Docetaxel + Sorafenib|"Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.~Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle."
10948785|NCT00801801|EG000|Reported Event|Metronomic Taxotere and Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
11177938|NCT02044796|EG008|Reported Event|Phase 2 Newly Diagnosed Group 18 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11341758|NCT03687736|OG000|Outcome|AbobotulinumtoxinA|"Open-label~AbobotulinumtoxinA: AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6"
11341759|NCT03687736|OG000|Outcome|abobotulinumtoxinA|"Open-label~AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region"
10948786|NCT00801827|BG000|Baseline|Surgical|Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
10948787|NCT00801827|FG000|Participant Flow|Surgical|Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
10948788|NCT00801827|OG000|Outcome|F-18 (Fallypride)|Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
10948789|NCT00801827|EG000|Reported Event|F-18 (Fallypride)|"Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.~F-18 (fallypride): Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation."
10948790|NCT00801892|BG000|Baseline|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
10948791|NCT00801892|BG001|Baseline|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
11177939|NCT02044796|EG009|Reported Event|Phase 2 Relapsed/Refractory Group 16 mg/m^2|"INDUCTION CHEMOTHERAPY (G-CLAM): Patients receive G-CLAM chemotherapy comprising filgrastim SC daily on days 0-5, mitoxantrone hydrochloride IV over 60 minutes on days 1-3, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Patients achieving CRi, partial remission, or persistent disease may receive a second course of induction chemotherapy. Patients achieving CR or CRp may continue on to Consolidation Chemotherapy.~CONSOLIDATION CHEMOTHERAPY (G-CLA): Beginning within 6 weeks of achieving CR/CRp/CRi, patients receive G-CLA comprising filgrastim SC on days 0-5, cladribine IV over 2 hours daily on days 1-5, and cytarabine IV over 2 hours daily on days 1-5. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Cytarabine: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
11177940|NCT02044874|BG000|Baseline|APD356 10 mg b.i.d.|APD356-lorcaserin hydrochloride 10 mg twice daily
11177941|NCT02044874|BG001|Baseline|APD356 10 mg q.d.|APD356-lorcaserin hydrochloride 10 mg once daily
10948792|NCT00801892|BG002|Baseline|Total|Total of all reporting groups
10948793|NCT00801892|FG000|Participant Flow|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
10948794|NCT00801892|FG001|Participant Flow|2=Sham-CPAP Then Active CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP originally; they were then allowed to cross over to the active CPAP after the main period~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
10948795|NCT00801892|OG000|Outcome|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
11177942|NCT02044874|BG002|Baseline|Placebo 10 mg b.i.d|Placebo 10 mg twice daily
11177943|NCT02044874|BG003|Baseline|Total|Total of all reporting groups
11177944|NCT02044874|FG000|Participant Flow|APD356 10 mg b.i.d.|APD356-lorcaserin hydrochloride
11177945|NCT02044874|FG001|Participant Flow|APD356 10 mg q.d.|APD356-lorcaserin hydrochloride
11177946|NCT02044874|FG002|Participant Flow|Placebo 10 mg b.i.d|Placebo
11177947|NCT02044874|OG000|Outcome|APD356 10 mg b.i.d.|APD356-lorcaserin hydrochloride
11177948|NCT02044874|OG001|Outcome|APD356 10 mg q.d.|APD356-lorcaserin hydrochloride
11177949|NCT02044874|OG002|Outcome|Placebo|Placebo
11177950|NCT02044874|OG000|Outcome|APD356 10 mg b.i.d.|APD356-lorcaserin hydrochloride 10 mg twice daily
11177951|NCT02044874|OG001|Outcome|APD356 10 mg q.d.|APD356-lorcaserin hydrochloride 10 mg once daily
11177952|NCT02044874|EG000|Reported Event|APD356 10 mg b.i.d.|APD356-lorcaserin hydrochloride 10 mg twice daily
11177953|NCT02044874|EG001|Reported Event|APD356 10 mg q.d.|APD356-lorcaserin hydrochloride 10 mg once daily
11177954|NCT02044874|EG002|Reported Event|Placebo|Placebo
11177955|NCT02044991|BG000|Baseline|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
11177956|NCT02044991|BG001|Baseline|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
11177957|NCT02044991|BG002|Baseline|Total|Total of all reporting groups
11177958|NCT02044991|FG000|Participant Flow|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
11177959|NCT02044991|FG001|Participant Flow|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
11177960|NCT02044991|OG000|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
11177961|NCT02044991|OG001|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
11177962|NCT02044991|EG000|Reported Event|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
11177963|NCT02044991|EG001|Reported Event|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
11177964|NCT02045095|BG000|Baseline|Schedule A: TAK-243 Total|TAK-243 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 18 mg, and 4mg homozygous mutant, infusion, IV over 10-minutes, twice-weekly on Days 1, 4, 8, and 11 in a 21-day treatment cycle for a maximum of 12 cycles, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177965|NCT02045095|FG000|Participant Flow|Schedule A: TAK-243 1 mg|TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
11177966|NCT02045095|FG001|Participant Flow|Schedule A: TAK-243 2 mg|TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
10948796|NCT00801892|OG001|Outcome|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
10948797|NCT00801892|OG000|Outcome|1 Subjects Treated With CPAP|"Continuous Positive Airway Pressure treatment (CPAP)~Continuous Positive Airway Pressure (CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
10948798|NCT00801892|OG001|Outcome|2 Subjects Treated With Sham-CPAP|"Sham Continuous Positive Airway Pressure treatment (sham-CPAP)~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
10948799|NCT00801892|EG000|Reported Event|1 Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
10948800|NCT00801892|EG001|Reported Event|2 = Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
10948801|NCT00801983|BG000|Baseline|Group A|Subject receives typical keyboard first (0-6 months) and alternative keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
10948802|NCT00801983|BG001|Baseline|Group B|Subject receives alternative keyboard first (0-6 months) and typical keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
10948803|NCT00801983|BG002|Baseline|Total|Total of all reporting groups
10948804|NCT00801983|FG000|Participant Flow|Group A (Typical/Alternative)|Subject receives typical keyboard for 5-6 months first and alternative keyboard second for 5-6 months (total 12 months in study
10948805|NCT00801983|FG001|Participant Flow|Group B (Alternative/Typical)|Subject receives alternate keyboard for 5-6 months first and typical keyboard second for 5-6 months (total 12 months in study
10948806|NCT00801983|OG000|Outcome|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
10948807|NCT00801983|OG001|Outcome|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
10948808|NCT00801983|EG000|Reported Event|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
10948809|NCT00801983|EG001|Reported Event|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
10948810|NCT00802074|BG000|Baseline|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948811|NCT00802074|BG001|Baseline|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948812|NCT00802074|BG002|Baseline|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948813|NCT00802074|BG003|Baseline|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948814|NCT00802074|BG004|Baseline|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948815|NCT00802074|BG005|Baseline|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948816|NCT00802074|BG006|Baseline|Total|Total of all reporting groups
10948817|NCT00802074|FG000|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
10948818|NCT00802074|FG001|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
10948819|NCT00802074|FG002|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
10948820|NCT00802074|FG003|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
10948821|NCT00802074|FG004|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
10948822|NCT00802074|FG005|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10948823|NCT00802074|OG000|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
10948824|NCT00802074|OG001|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
10948825|NCT00802074|OG002|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
10948826|NCT00802074|OG000|Outcome|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948827|NCT00802074|OG001|Outcome|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948828|NCT00802074|OG002|Outcome|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948829|NCT00802074|OG003|Outcome|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948830|NCT00802074|OG004|Outcome|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
10948831|NCT00802074|OG005|Outcome|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
11177967|NCT02045095|FG002|Participant Flow|Schedule A: TAK-243 4 mg|TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177968|NCT02045095|FG003|Participant Flow|Schedule A: TAK-243 8 mg|TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177969|NCT02045095|FG004|Participant Flow|Schedule A: TAK-243 12 mg|TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177970|NCT02045095|FG005|Participant Flow|Schedule A: TAK-243 18 mg|TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177971|NCT02045095|FG006|Participant Flow|Schedule A: TAK-243 Homozygous Mutant 4 mg|TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177972|NCT02045095|OG000|Outcome|Schedule A: TAK-243 1 mg|TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
11177973|NCT02045095|OG001|Outcome|Schedule A: TAK-243 2 mg|TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
11177974|NCT02045095|OG002|Outcome|Schedule A: TAK-243 4 mg|TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177975|NCT02045095|OG003|Outcome|Schedule A: TAK-243 8 mg|TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11341760|NCT03687736|EG000|Reported Event|AbobotulinumtoxinA|"Open-label~AbobotulinumtoxinA: AbobotulinumtoxinA treatment in the glabellar region"
10948832|NCT00802074|EG000|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
10948833|NCT00802074|EG001|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
10948834|NCT00802074|EG002|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
10948835|NCT00802074|EG003|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
10948836|NCT00802074|EG004|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
10948837|NCT00802074|EG005|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
10948838|NCT00802100|BG000|Baseline|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
10948839|NCT00802100|BG001|Baseline|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
10948840|NCT00802100|BG002|Baseline|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
10948841|NCT00802100|BG003|Baseline|Total|Total of all reporting groups
10948842|NCT00802100|FG000|Participant Flow|Olanzapine|"Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.~Olanzapine dose 10-30 mg/day Metformin dose 850-2550 mg/day"
10948843|NCT00802100|FG001|Participant Flow|Perphenazine|"Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.~Perphenazine dose 8-24 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
10948844|NCT00802100|FG002|Participant Flow|Aripiprazole|"Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.~Aripiprazole dose 10-30 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
10948845|NCT00802100|OG000|Outcome|Overall Study|This refers to the feasibility of the entire pilot study. Only 21 eligible participants of the goal of 60 were randomized because sites were unable to identify adequate numbers of eligible participants.
10948846|NCT00802100|OG000|Outcome|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
10948847|NCT00802100|OG001|Outcome|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
10948848|NCT00802100|OG002|Outcome|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
10948849|NCT00802100|EG000|Reported Event|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
10948850|NCT00802100|EG001|Reported Event|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
10948851|NCT00802100|EG002|Reported Event|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
10948852|NCT00802113|BG000|Baseline|Arm A - Family Donor|Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.
10948853|NCT00802113|BG001|Baseline|Arm B - Unrelated Cord Blood or Adult|Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
11177976|NCT02045095|OG004|Outcome|Schedule A: TAK-243 12 mg|TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
10948854|NCT00802113|BG002|Baseline|Total|Total of all reporting groups
10948855|NCT00802113|FG000|Participant Flow|Arm A - Family Donor|Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.
10948856|NCT00802113|FG001|Participant Flow|Arm B - Unrelated Cord Blood or Adult|Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
10948857|NCT00802113|OG000|Outcome|Arm A - Family Donor|Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.
10948858|NCT00802113|OG001|Outcome|Arm B - Unrelated Cord Blood or Adult|Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
10948859|NCT00802113|EG000|Reported Event|Arm A - Family Donor|Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.
10948860|NCT00802113|EG001|Reported Event|Arm B - Unrelated Cord Blood or Adult|Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
10948861|NCT00802178|BG000|Baseline|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
10948862|NCT00802178|FG000|Participant Flow|Mirapexin® (Pramipexole)|"The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics.~mode of administration (admin.): Tablets for oral use"
10948863|NCT00802178|OG000|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
10948864|NCT00802178|EG000|Reported Event|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
10964073|NCT00875667|FG001|Participant Flow|Investigators Choice|Participants received a single agent investigators choice (IC) of chlorambucil 40 mg/m^2 PO every 28 days until progressive disease (PD) or toxicity, OR rituximab 375 mg/m^2 by intravenous (IV) infusion on days 1, 8, 15 and 22 of each 56-day treatment cycle until PD or toxicity, OR cytarabine 1-2 g/m^2 by IV infusion on days 1 and 2 of each 28 day treatment cycle; up to 6 cycles, OR gemcitabine 1000 mg/m^2 by IV infusion on days 1, 8 and 15 of each 28 day treatment cycle; up to 6 cycles OR oral fludarabine 40 mg/m^2 or IV fludarabine 25 mg/m^2 on days 1 through 5 of each 28-day cycle; up to 6 cycles. Participants were given the option to enter into the lenalidomide crossover phase if PD occurred and received lenalidomide 25 mg capsules daily on days 1 to 21 of each 28 day treatment cycle until PD or toxicity.
10948865|NCT00802204|BG000|Baseline|Lean|
10948866|NCT00802204|BG001|Baseline|Obese|
10948867|NCT00802204|BG002|Baseline|Total|Total of all reporting groups
10948868|NCT00802204|FG000|Participant Flow|Lean|BMI<~25kg/m2
10948869|NCT00802204|FG001|Participant Flow|Obese|BMI>/=30kg/m2
10948870|NCT00802204|OG000|Outcome|Lean Baseline|
10948871|NCT00802204|OG001|Outcome|Obese Baseline|
10948872|NCT00802204|OG002|Outcome|Obese Post-diet|
10948873|NCT00802204|OG000|Outcome|Lean|
10948874|NCT00802204|OG001|Outcome|Obese|
11177977|NCT02045095|OG005|Outcome|Schedule A: TAK-243 18 mg|TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177978|NCT02045095|OG006|Outcome|Schedule A: TAK-243 Homozygous Mutant 4 mg|TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
10948875|NCT00802204|EG000|Reported Event|Lean|
10948876|NCT00802204|EG001|Reported Event|Obese|
10948877|NCT00802360|BG000|Baseline|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948878|NCT00802360|BG001|Baseline|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948879|NCT00802360|BG002|Baseline|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948880|NCT00802360|BG003|Baseline|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948881|NCT00802360|BG004|Baseline|Total|Total of all reporting groups
10948882|NCT00802360|FG000|Participant Flow|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948883|NCT00802360|FG001|Participant Flow|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948884|NCT00802360|FG002|Participant Flow|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948885|NCT00802360|FG003|Participant Flow|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948886|NCT00802360|OG000|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
10948887|NCT00802360|OG001|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
10948888|NCT00802360|OG000|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948889|NCT00802360|OG001|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948890|NCT00802360|OG002|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948891|NCT00802360|OG003|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948892|NCT00802360|EG000|Reported Event|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948893|NCT00802360|EG001|Reported Event|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948894|NCT00802360|EG002|Reported Event|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948895|NCT00802360|EG003|Reported Event|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10948896|NCT00802412|BG000|Baseline|Topiramate|Received active topiramate
10948897|NCT00802412|BG001|Baseline|Placebo|Received placebo
10948898|NCT00802412|BG002|Baseline|Total|Total of all reporting groups
10948899|NCT00802412|FG000|Participant Flow|Topiramate|"The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.~Topiramate: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days)."
10948900|NCT00802412|FG001|Participant Flow|Placebo|"90 participants, will receive matching placebo~Placebo: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design."
10948901|NCT00802412|OG000|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
10948902|NCT00802412|OG001|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
10948903|NCT00802412|EG000|Reported Event|Topiramate|
11177979|NCT02045095|EG000|Reported Event|Schedule A: TAK-243 1 mg|TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
10948904|NCT00802412|EG001|Reported Event|Placebo|
10948905|NCT00802438|BG000|Baseline|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
10948906|NCT00802438|FG000|Participant Flow|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
10948907|NCT00802438|OG000|Outcome|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
10948908|NCT00802438|EG000|Reported Event|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
10948909|NCT00802464|BG000|Baseline|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948910|NCT00802464|BG001|Baseline|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948911|NCT00802464|BG002|Baseline|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948912|NCT00802464|BG003|Baseline|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948913|NCT00802464|BG004|Baseline|Total|Total of all reporting groups
10948914|NCT00802464|FG000|Participant Flow|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948915|NCT00802464|FG001|Participant Flow|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
11177980|NCT02045095|EG001|Reported Event|Schedule A: TAK-243 2 mg|TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
11177981|NCT02045095|EG002|Reported Event|Schedule A: TAK-243 4 mg|TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177982|NCT02045095|EG003|Reported Event|Schedule A: TAK-243 8 mg|TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
10948916|NCT00802464|FG002|Participant Flow|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948917|NCT00802464|FG003|Participant Flow|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948918|NCT00802464|OG000|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948919|NCT00802464|OG001|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948920|NCT00802464|OG002|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948921|NCT00802464|OG003|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948922|NCT00802464|OG001|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948923|NCT00802464|OG003|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
11177983|NCT02045095|EG004|Reported Event|Schedule A: TAK-243 12 mg|TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177984|NCT02045095|EG005|Reported Event|Schedule A: TAK-243 18 mg|TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177985|NCT02045095|EG006|Reported Event|Schedule A: TAK-243 Homozygous Mutant 4 mg|TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
11177986|NCT02045108|BG000|Baseline|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
10948924|NCT00802464|EG000|Reported Event|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948925|NCT00802464|EG001|Reported Event|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948926|NCT00802464|EG002|Reported Event|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948927|NCT00802464|EG003|Reported Event|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
10948928|NCT00802503|BG000|Baseline|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
10948929|NCT00802503|BG001|Baseline|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
10948930|NCT00802503|BG002|Baseline|Total|Total of all reporting groups
10948931|NCT00802503|FG000|Participant Flow|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
10948932|NCT00802503|FG001|Participant Flow|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
10948933|NCT00802503|OG000|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
10948934|NCT00802503|OG001|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
10948935|NCT00802503|OG000|Outcome|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
10948936|NCT00802503|OG000|Outcome|Controle gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
10948937|NCT00802503|OG001|Outcome|SPN gr|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
10948938|NCT00802503|OG000|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
10948939|NCT00802503|EG000|Reported Event|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
10948940|NCT00802503|EG001|Reported Event|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
10948941|NCT00802529|BG000|Baseline|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
10948942|NCT00802529|BG001|Baseline|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
10948943|NCT00802529|BG002|Baseline|Total|Total of all reporting groups
10948944|NCT00802529|FG000|Participant Flow|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks. Each injection was 62.5mg/ml.
10948945|NCT00802529|FG001|Participant Flow|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.Each injection was 40mg/ml.
10948946|NCT00802529|OG000|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
10948947|NCT00802529|OG001|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
10948948|NCT00802529|EG000|Reported Event|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
11177987|NCT02045108|BG001|Baseline|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
11177988|NCT02045108|BG002|Baseline|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
11177989|NCT02045108|BG003|Baseline|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
11177990|NCT02045108|BG004|Baseline|Total|Total of all reporting groups
10948949|NCT00802529|EG001|Reported Event|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
10948950|NCT00802633|BG000|Baseline|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
10948951|NCT00802633|BG001|Baseline|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
10948952|NCT00802633|BG002|Baseline|Total|Total of all reporting groups
10948953|NCT00802633|FG000|Participant Flow|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
10948954|NCT00802633|FG001|Participant Flow|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
10948955|NCT00802633|OG000|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
10948956|NCT00802633|OG001|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
10948957|NCT00802633|EG000|Reported Event|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
10948958|NCT00802633|EG001|Reported Event|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
10948959|NCT00802672|BG000|Baseline|Test Product|Ciclopirox cream
10948960|NCT00802672|BG001|Baseline|Reference Product|Loprox Cream
10948961|NCT00802672|BG002|Baseline|Vehicle Product|placebo
10948962|NCT00802672|BG003|Baseline|Total|Total of all reporting groups
10948963|NCT00802672|FG000|Participant Flow|Test Product|Ciclopirox cream
10948964|NCT00802672|FG001|Participant Flow|Reference Product|Loprox Cream
10948965|NCT00802672|FG002|Participant Flow|Vehicle Product|placebo
10948966|NCT00802672|OG000|Outcome|Test Product|Ciclopirox Olamine Cream, USP
10948967|NCT00802672|OG001|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
10948968|NCT00802672|OG002|Outcome|Vehicle Product|Vehicle
10948969|NCT00802672|EG000|Reported Event|Test Product|Ciclopirox Olamine Cream, USP
10948970|NCT00802672|EG001|Reported Event|Reference Product|Loprox® (ciclopirox) Cream 0.77%
10948971|NCT00802672|EG002|Reported Event|Vehicle Product|Vehicle
10948972|NCT00802685|BG000|Baseline|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
10948973|NCT00802685|BG001|Baseline|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
10948974|NCT00802685|BG002|Baseline|Total|Total of all reporting groups
10948975|NCT00802685|FG000|Participant Flow|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
10948976|NCT00802685|FG001|Participant Flow|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
10948977|NCT00802685|OG000|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
10948978|NCT00802685|OG001|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
10948979|NCT00802685|EG000|Reported Event|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
10948980|NCT00802685|EG001|Reported Event|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
10948981|NCT00802737|BG000|Baseline|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
10948982|NCT00802737|BG001|Baseline|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
10948983|NCT00802737|BG002|Baseline|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
10948984|NCT00802737|BG003|Baseline|Total|Total of all reporting groups
11177991|NCT02045108|FG000|Participant Flow|Active TDCS + Active Retraining|"2.0 milliamps (mA) of transcranial direct current stimulation (TDCS) applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
11177992|NCT02045108|FG001|Participant Flow|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
11177993|NCT02045108|FG002|Participant Flow|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
11177994|NCT02045108|FG003|Participant Flow|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
10948985|NCT00802737|FG000|Participant Flow|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
10948986|NCT00802737|FG001|Participant Flow|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
10948987|NCT00802737|FG002|Participant Flow|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
10948988|NCT00802737|OG000|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
10948989|NCT00802737|OG001|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
10948990|NCT00802737|OG002|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
10948991|NCT00802737|OG003|Outcome|Total|This arm includes a total of all three arms combined.
10948992|NCT00802737|EG000|Reported Event|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
10948993|NCT00802737|EG001|Reported Event|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
10948994|NCT00802737|EG002|Reported Event|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
11177995|NCT02045108|OG000|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
11177996|NCT02045108|OG001|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
11177997|NCT02045108|OG002|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
10948995|NCT00802841|BG000|Baseline|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
10948996|NCT00802841|BG001|Baseline|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
10948997|NCT00802841|BG002|Baseline|Total|Total of all reporting groups
10948998|NCT00802841|FG000|Participant Flow|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
10948999|NCT00802841|FG001|Participant Flow|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
10949000|NCT00802841|OG000|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
10949001|NCT00802841|OG001|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
10949002|NCT00802841|EG000|Reported Event|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
10949003|NCT00802841|EG001|Reported Event|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
10949004|NCT00802841|EG002|Reported Event|Cross-over to Nilotinib|Nilotinib 400 mg BID
11177998|NCT02045108|OG003|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
11177999|NCT02045108|EG000|Reported Event|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
11178000|NCT02045108|EG001|Reported Event|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
10949005|NCT00802841|EG003|Reported Event|Cross-over to Imatinib|600 mg QD
11178001|NCT02045108|EG002|Reported Event|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
11178002|NCT02045108|EG003|Reported Event|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
11178003|NCT02045212|BG000|Baseline|RPh201|"3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201~RPh201: SC injection twice a week during 13/26 weeks"
11178004|NCT02045212|BG001|Baseline|Placebo|"3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo~Placebo: SC injection twice a week during 13/26 weeks"
11178005|NCT02045212|BG002|Baseline|Total|Total of all reporting groups
11178006|NCT02045212|FG000|Participant Flow|RPh201|"3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201~RPh201: SC injection twice a week during 13/26 weeks"
10949006|NCT00802854|BG000|Baseline|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
10949007|NCT00802854|FG000|Participant Flow|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
10949008|NCT00802854|OG000|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
10949009|NCT00802854|EG000|Reported Event|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
10949010|NCT00802867|BG000|Baseline|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
10949011|NCT00802867|FG000|Participant Flow|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
10949012|NCT00802867|OG000|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
10949013|NCT00802867|EG000|Reported Event|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
10949014|NCT00802880|BG000|Baseline|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
10949015|NCT00802880|FG000|Participant Flow|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
10949016|NCT00802880|OG000|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
11178007|NCT02045212|FG001|Participant Flow|Placebo|"3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo~Placebo: SC injection twice a week during 13/26 weeks"
11178008|NCT02045212|OG000|Outcome|RPh201|"3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201~RPh201: SC injection twice a week during 13/26 weeks"
11178009|NCT02045212|OG001|Outcome|Placebo|"3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo~Placebo: SC injection twice a week during 13/26 weeks"
11178010|NCT02045212|OG000|Outcome|RPh201|"26 weeks treatment schedule, consisting of bi-weekly SC administration of the RPh201~RPh201: SC injection twice a week during 26 weeks"
11178011|NCT02045212|OG001|Outcome|Placebo|"26 weeks treatment schedule, consisting of bi-weekly SC administration of the Placebo~Placebo: SC injection twice a week during 26 weeks"
11178012|NCT02045212|OG000|Outcome|RPh201|"26 weeks treatment schedule, consisting of bi-weekly SC administration of the RPh201~RPh201: SC injection twice a week during up to 26 weeks"
11178013|NCT02045212|OG001|Outcome|Placebo|"26 weeks treatment schedule, consisting of bi-weekly SC administration of the Placebo~Placebo: SC injection twice a week during up to 26 weeks"
10949017|NCT00802880|OG000|Outcome|Partial Metabolic Response|
10949018|NCT00802880|OG001|Outcome|Stable Metabolic Disease|
10949019|NCT00802880|OG002|Outcome|Progressive Metabolic Disease|
10949020|NCT00802880|OG003|Outcome|Total|
10949021|NCT00802880|EG000|Reported Event|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
10949022|NCT00802919|BG000|Baseline|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
10949023|NCT00802919|BG001|Baseline|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
10949024|NCT00802919|BG002|Baseline|Total|Total of all reporting groups
10949025|NCT00802919|FG000|Participant Flow|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
10949026|NCT00802919|FG001|Participant Flow|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
10949027|NCT00802919|OG000|Outcome|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
10949028|NCT00802919|OG001|Outcome|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
10949029|NCT00802919|OG000|Outcome|Varenicline|"Varenciline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
10949030|NCT00802919|EG000|Reported Event|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
10949031|NCT00802919|EG001|Reported Event|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
10949032|NCT00802945|BG000|Baseline|NKTR-102 14 Day|"NKTR-102~NKTR-102: NKTR-102 given on a q14 day schedule"
10949033|NCT00802945|BG001|Baseline|NKTR-102 21 Days|"NKTR-102~NKTR-102: NKTR-102 given on a q21 day schedule"
10949034|NCT00802945|BG002|Baseline|Total|Total of all reporting groups
10949035|NCT00802945|FG000|Participant Flow|NKTR-102 14 Day|NKTR-102: NKTR-102 given on a q14 day schedule
10949036|NCT00802945|FG001|Participant Flow|NKTR-102 21 Days|NKTR-102: NKTR-102 given on a q21 day schedule
10949037|NCT00802945|OG000|Outcome|NKTR-102 14 Day|NKTR-102: NKTR-102 given on a q14 day schedule
10949038|NCT00802945|OG001|Outcome|NKTR-102 21 Days|NKTR-102: NKTR-102 given on a q21 day schedule
10949039|NCT00802945|OG000|Outcome|NKTR-102 14 Day|"NKTR-102~NKTR-102: NKTR-102 given on a q14 day schedule"
10949040|NCT00802945|OG001|Outcome|NKTR-102 21 Days|"NKTR-102~NKTR-102: NKTR-102 given on a q21 day schedule"
10949041|NCT00802945|EG000|Reported Event|NKTR-102 14 Day|NKTR-102: NKTR-102 given on a q14 day schedule
10949042|NCT00802945|EG001|Reported Event|NKTR-102 21 Days|NKTR-102: NKTR-102 given on a q21 day schedule
10949043|NCT00802997|BG000|Baseline|Lateral Branch Neurotomy|
10949044|NCT00802997|BG001|Baseline|Sham Procedure|
10949045|NCT00802997|BG002|Baseline|Total|Total of all reporting groups
10949046|NCT00802997|FG000|Participant Flow|Lateral Branch Neurotomy|The lateral branch neurotomy procedure involved the ablation of the S1-S3 lateral branches and the L5 dorsal ramus using cooled radiofrequency electrodes. The procedure was completed one time within 60 days of enrollment.
10949047|NCT00802997|FG001|Participant Flow|Sham Procedure|The sham procedure was identical to the active treatment procedure but without the delivery of radiofrequency energy. The sham procedure was completed one time within 60 days of enrollment.
10949048|NCT00802997|OG000|Outcome|Lateral Branch Neurotomy|
10949049|NCT00802997|OG001|Outcome|Sham Procedure|
10949050|NCT00802997|EG000|Reported Event|Lateral Branch Neurotomy|
10949051|NCT00802997|EG001|Reported Event|Sham Procedure|
10949052|NCT00803010|BG000|Baseline|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
10949053|NCT00803010|BG001|Baseline|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
10949054|NCT00803010|BG002|Baseline|Total|Total of all reporting groups
10949055|NCT00803010|FG000|Participant Flow|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
10949056|NCT00803010|FG001|Participant Flow|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
10949057|NCT00803010|OG000|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
10949058|NCT00803010|OG001|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
10949059|NCT00803010|EG000|Reported Event|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
10949060|NCT00803010|EG001|Reported Event|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
10949061|NCT00803023|BG000|Baseline|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
10949062|NCT00803023|BG001|Baseline|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
10949063|NCT00803023|BG002|Baseline|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
11178014|NCT02045212|EG000|Reported Event|RPh201|"3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201~RPh201: SC injection twice a week during 13/26 weeks"
11178015|NCT02045212|EG001|Reported Event|Placebo|"3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo~Placebo: SC injection twice a week during 13/26 weeks"
11178016|NCT02045238|BG000|Baseline|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
11178017|NCT02045238|BG001|Baseline|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
11178018|NCT02045238|BG002|Baseline|Total|Total of all reporting groups
10949064|NCT00803023|BG003|Baseline|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
10949065|NCT00803023|BG004|Baseline|Total|Total of all reporting groups
10949066|NCT00803023|FG000|Participant Flow|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
10949067|NCT00803023|FG001|Participant Flow|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
10949068|NCT00803023|FG002|Participant Flow|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
10949069|NCT00803023|FG003|Participant Flow|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
11178019|NCT02045238|FG000|Participant Flow|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
11178020|NCT02045238|FG001|Participant Flow|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
11178021|NCT02045238|OG000|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
11178022|NCT02045238|OG001|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
10949070|NCT00803023|OG000|Outcome|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
10949071|NCT00803023|OG001|Outcome|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
10949072|NCT00803023|OG002|Outcome|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
10949073|NCT00803023|OG003|Outcome|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
10949074|NCT00803023|EG000|Reported Event|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
10949075|NCT00803023|EG001|Reported Event|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
10949076|NCT00803023|EG002|Reported Event|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
10949077|NCT00803023|EG003|Reported Event|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
10949078|NCT00803049|BG000|Baseline|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
10949079|NCT00803049|BG001|Baseline|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
10949080|NCT00803049|BG002|Baseline|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
10949081|NCT00803049|BG003|Baseline|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
10949082|NCT00803049|BG004|Baseline|Total|Total of all reporting groups
10949083|NCT00803049|FG000|Participant Flow|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
10949084|NCT00803049|FG001|Participant Flow|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
10949085|NCT00803049|FG002|Participant Flow|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
10949086|NCT00803049|FG003|Participant Flow|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
10949087|NCT00803049|OG000|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
10949088|NCT00803049|OG001|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
10949089|NCT00803049|OG002|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
10949090|NCT00803049|OG003|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
10949091|NCT00803049|EG000|Reported Event|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
10949092|NCT00803049|EG001|Reported Event|Teriflunomide 7 mg/7 mg|"Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.~Included 2 participants randomized in placebo and teriflunomide 14 mg arm respectively in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participants received correct dose of teriflunomide 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
10949093|NCT00803049|EG002|Reported Event|Placebo/Teriflunomide 14 mg|"Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.~Excluded 1 participant randomized in placebo arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received 14 mg dose but included in teriflunomide 7 mg/7 mg arm for safety analysis."
10949094|NCT00803049|EG003|Reported Event|Teriflunomide 14 mg/14 mg|"Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.~Excluded 1 participant randomized in 14 mg arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received correct dose of 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
10949095|NCT00803062|BG000|Baseline|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
10949096|NCT00803062|BG001|Baseline|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
10949097|NCT00803062|BG002|Baseline|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
10949098|NCT00803062|BG003|Baseline|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
10949099|NCT00803062|BG004|Baseline|Total|Total of all reporting groups
10949100|NCT00803062|FG000|Participant Flow|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
10949101|NCT00803062|FG001|Participant Flow|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
10949102|NCT00803062|FG002|Participant Flow|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
10949103|NCT00803062|FG003|Participant Flow|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
10949104|NCT00803062|OG000|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
10949105|NCT00803062|OG001|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
10949106|NCT00803062|OG002|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
10949107|NCT00803062|OG003|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
10949108|NCT00803062|EG000|Reported Event|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
10949109|NCT00803062|EG001|Reported Event|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
10949110|NCT00803062|EG002|Reported Event|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
10949111|NCT00803062|EG003|Reported Event|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
10949112|NCT00803101|BG000|Baseline|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
10949113|NCT00803101|BG001|Baseline|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
10949114|NCT00803101|BG002|Baseline|Total|Total of all reporting groups
10949115|NCT00803101|FG000|Participant Flow|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline international normalized ratio (INR), amount of coagulation factor IX and body-weight.
11178023|NCT02045238|EG000|Reported Event|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
10949116|NCT00803101|FG001|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
10949117|NCT00803101|OG000|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
10949118|NCT00803101|OG001|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
10949119|NCT00803101|EG000|Reported Event|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
10949120|NCT00803101|EG001|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
10949121|NCT00803205|BG000|Baseline|Ataluren|Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
10949122|NCT00803205|BG001|Baseline|Placebo|Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
10949123|NCT00803205|BG002|Baseline|Total|Total of all reporting groups
11178024|NCT02045238|EG001|Reported Event|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
11178025|NCT02045264|BG000|Baseline|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
10949124|NCT00803205|FG000|Participant Flow|Ataluren|Participants received ataluren 3 times daily (TID): 10 milligrams/kilogram (mg/kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
10949125|NCT00803205|FG001|Participant Flow|Placebo|Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
10949126|NCT00803205|OG000|Outcome|Ataluren|Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
10949127|NCT00803205|OG001|Outcome|Placebo|Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
10949128|NCT00803205|EG000|Reported Event|Ataluren|Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
10949129|NCT00803205|EG001|Reported Event|Placebo|Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
10949130|NCT00803244|BG000|Baseline|300 IR|300 IR grass pollen allergen extract tablet
10949131|NCT00803244|BG001|Baseline|Placebo|Placebo tablet
10949132|NCT00803244|BG002|Baseline|Total|Total of all reporting groups
10949133|NCT00803244|FG000|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
10949134|NCT00803244|FG001|Participant Flow|Placebo|Placebo tablet
10949135|NCT00803244|OG000|Outcome|300 IR|300 IR grass pollen allergen extract tablet
10949136|NCT00803244|OG001|Outcome|Placebo|Placebo tablet
10949137|NCT00803244|EG000|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
10949138|NCT00803244|EG001|Reported Event|Placebo|Placebo tablet
10949139|NCT00803270|BG000|Baseline|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
10949140|NCT00803270|BG001|Baseline|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
10949141|NCT00803270|BG002|Baseline|Total|Total of all reporting groups
10949142|NCT00803270|FG000|Participant Flow|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
10949143|NCT00803270|FG001|Participant Flow|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and~Behavioral therapy."
10949144|NCT00803270|OG000|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
10949145|NCT00803270|OG001|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
10949146|NCT00803270|EG000|Reported Event|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
10949147|NCT00803270|EG001|Reported Event|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
10949148|NCT00803361|BG000|Baseline|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
10949149|NCT00803361|BG001|Baseline|Placebo|placebo capsules, oral, once a day for 15 weeks
10949150|NCT00803361|BG002|Baseline|Total|Total of all reporting groups
10949151|NCT00803361|FG000|Participant Flow|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
10949152|NCT00803361|FG001|Participant Flow|Placebo|placebo capsules, oral, once a day for 15 weeks
10949153|NCT00803361|OG000|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
10949154|NCT00803361|OG001|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
10949155|NCT00803361|EG000|Reported Event|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
10949156|NCT00803361|EG001|Reported Event|Placebo|placebo capsules, oral, once a day for 15 weeks
10949157|NCT00803400|BG000|Baseline|Alprazolam|Patients receiving only alprazolam
10949158|NCT00803400|BG001|Baseline|Alprazolam + Aerobic Exercise|Patients receiving alprazolam + aerobic exercise
10949159|NCT00803400|BG002|Baseline|Total|Total of all reporting groups
10949160|NCT00803400|FG000|Participant Flow|Alprazolam|Pacients receiving only alprazolam
10949161|NCT00803400|FG001|Participant Flow|Alprazolam + Aerobic Exercise|Pacients receiving alprazolam + aerobic exercise
10949162|NCT00803400|OG000|Outcome|Alprazolam|Patients receiving only alprazolam
10949163|NCT00803400|OG001|Outcome|Alprazolam + Aerobic Exercise|Patients receiving alprazolam + aerobic exercise
10949164|NCT00803400|OG000|Outcome|Alprazolam|Patients only receiving alprazolam
10949165|NCT00803400|EG000|Reported Event|Alprazolam|Pacients receiving only alprazolam
10949166|NCT00803400|EG001|Reported Event|Alprazolam + Aerobic Exercise|Pacients receiving alprazolam + aerobic exercise
10949167|NCT00803452|BG000|Baseline|Doxycycline|"Oral doxycycline~doxycycline: Oral doxycycline 100mg bid"
10949168|NCT00803452|BG001|Baseline|Azithromycin|"Topical azithromycin daily to the conjunctival culdesac~azithromycin: topical 1% azithromycin daily to eye"
10949169|NCT00803452|BG002|Baseline|Total|Total of all reporting groups
10949170|NCT00803452|FG000|Participant Flow|Doxycycline|"Oral doxycycline~doxycycline: Oral doxycycline 100mg bid"
10949171|NCT00803452|FG001|Participant Flow|Azithromycin|"Topical azithromycin daily to the conjunctival culdesac~azithromycin: topical 1% azithromycin daily to eye"
10949172|NCT00803452|OG000|Outcome|Doxycycline|"Oral doxycycline~doxycycline: Oral doxycycline 100mg bid"
10949173|NCT00803452|OG001|Outcome|Azithromycin|"Topical azithromycin daily to the conjunctival culdesac~azithromycin: topical 1% azithromycin daily to eye"
10949174|NCT00803452|EG000|Reported Event|Doxycycline|"Oral doxycycline~doxycycline: Oral doxycycline 100mg bid"
10949175|NCT00803452|EG001|Reported Event|Azithromycin|"Topical azithromycin daily to the conjunctival culdesac~azithromycin: topical 1% azithromycin daily to eye"
10949176|NCT00803543|BG000|Baseline|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
10949177|NCT00803543|BG001|Baseline|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
10949178|NCT00803543|BG002|Baseline|Total|Total of all reporting groups
10949179|NCT00803543|FG000|Participant Flow|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
10949180|NCT00803543|FG001|Participant Flow|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
10949181|NCT00803543|OG000|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
10949182|NCT00803543|OG001|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
10949183|NCT00803543|EG000|Reported Event|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
10949184|NCT00803543|EG001|Reported Event|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
10949185|NCT00803569|BG000|Baseline|ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF|Patients received SC injections with ALVAC(2)-NY-ESO-1(M)/TRICOM (0.5 mL) on Day 1 and the GM-CSF sargramostim (100 μg) on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles.
10949186|NCT00803569|FG000|Participant Flow|ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF|Patients received subcutaneous (SC) injections with ALVAC(2)-NY-ESO-1(M)/TRICOM (0.5 mL) on Day 1 and the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramostim (100 μg) on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles.
10949187|NCT00803569|OG000|Outcome|ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF|Patients received SC injections with ALVAC(2)-NY-ESO-1(M)/TRICOM (0.5 mL) on Day 1 and the GM-CSF sargramostim (100 μg) on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles.
10949188|NCT00803569|EG000|Reported Event|ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF|Patients received SC injections with ALVAC(2)-NY-ESO-1(M)/TRICOM (0.5 mL) on Day 1 and the GM-CSF sargramostim (100 μg) on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles.
10949189|NCT00803595|BG000|Baseline|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
10949190|NCT00803595|BG001|Baseline|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
10949191|NCT00803595|BG002|Baseline|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
10949192|NCT00803595|BG003|Baseline|Total|Total of all reporting groups
10949193|NCT00803595|FG000|Participant Flow|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
10949194|NCT00803595|FG001|Participant Flow|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
10949195|NCT00803595|FG002|Participant Flow|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
10949196|NCT00803595|OG000|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
10949197|NCT00803595|OG001|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
10949198|NCT00803595|OG002|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
10949199|NCT00803595|EG000|Reported Event|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
10949200|NCT00803595|EG001|Reported Event|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
10949201|NCT00803595|EG002|Reported Event|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
10949202|NCT00803634|BG000|Baseline|Clevidipine Emulsion|All randomized and eligible patients who received any dose of clevidipine.
10949203|NCT00803634|BG001|Baseline|SOC IV Antihypertensive Therapy|All randomized and eligible patients who received any SOC dose.
10949204|NCT00803634|BG002|Baseline|Total|Total of all reporting groups
10949205|NCT00803634|FG000|Participant Flow|Clevidipine|Clevidipine (0.5 mg/mL in 20% lipid emulsion) was administered intravenously via a single dedicated line to all patients randomized to the clevidipine arm. Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
10949206|NCT00803634|FG001|Participant Flow|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
10949207|NCT00803634|OG000|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
10949208|NCT00803634|OG001|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
10949209|NCT00803634|OG001|Outcome|SOC IV Therapy|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
11178026|NCT02045264|FG000|Participant Flow|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
10949210|NCT00803634|EG000|Reported Event|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
10949211|NCT00803634|EG001|Reported Event|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
10949212|NCT00803647|BG000|Baseline|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
10949213|NCT00803647|FG000|Participant Flow|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
10949214|NCT00803647|OG000|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
10949215|NCT00803647|EG000|Reported Event|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
10949216|NCT00803686|BG000|Baseline|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
10949217|NCT00803686|BG001|Baseline|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
10949218|NCT00803686|BG002|Baseline|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
11178027|NCT02045264|OG000|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
11178028|NCT02045264|EG000|Reported Event|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
11178029|NCT02045277|BG000|Baseline|IDP-118 Lotion|"halobetasol propionate [HP], tazarotene [Taz]~IDP-118 Lotion: Lotion"
10949219|NCT00803686|BG003|Baseline|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
10949220|NCT00803686|BG004|Baseline|Total|Total of all reporting groups
10949221|NCT00803686|FG000|Participant Flow|Oral Recombinant Salmon Calcitonin (rsCT)|In Part 1, Period 1, 6 Subjects each were given rsCT tablets or 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral placebo 4 hours after the evening meal.
10949222|NCT00803686|FG001|Participant Flow|Oral Placebo|In Part 1, Period 1, 6 Subjects each were given oral placebo tablets 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral rsCT tablets 4 hours after the evening meal.
10949223|NCT00803686|FG002|Participant Flow|Oral rsCT Tablets (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter open label Part 2, Period 3, and received oral rsCT tablets given 2 hours after the evening meal.
10949224|NCT00803686|FG003|Participant Flow|Fortical Nasal Spray (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter the open label Part 2, Period 3 and were given Fortical Nasal Spray 2 hours after the evening meal
10949225|NCT00803686|OG000|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
11178030|NCT02045277|BG001|Baseline|IDP-118 Monad HP Lotion|"HP~IDP-118 Monad HP Lotion: Active Comparator"
10949226|NCT00803686|OG001|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
10949227|NCT00803686|OG002|Outcome|Part 2 Oral rsCT Tablets|Subjects were given oral rsCT tablets four hours after the evening meal
10949228|NCT00803686|OG003|Outcome|Part 2 Fortical Intra-nasal Spray|Subjects were given Fortical (rsCT) nasal spray four hours after the evening meal
10949229|NCT00803686|OG002|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
10949230|NCT00803686|OG003|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
10949231|NCT00803686|EG000|Reported Event|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
10949232|NCT00803686|EG001|Reported Event|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
10949233|NCT00803686|EG002|Reported Event|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
10949234|NCT00803686|EG003|Reported Event|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
10949235|NCT00803712|BG000|Baseline|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
10949236|NCT00803712|BG001|Baseline|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
10949237|NCT00803712|BG002|Baseline|Total|Total of all reporting groups
10949238|NCT00803712|FG000|Participant Flow|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
11178031|NCT02045277|BG002|Baseline|IDP-118 Monad Taz Lotion|"Taz~IDP-118 Monad Taz Lotion: Active Comparator"
11178032|NCT02045277|BG003|Baseline|IDP-118 Vehicle Lotion|"Vehicle~IDP-118 Vehicle Lotion: Vehicle"
11178033|NCT02045277|BG004|Baseline|Total|Total of all reporting groups
11178034|NCT02045277|FG000|Participant Flow|IDP-118 Lotion|"halobetasol propionate [HP], tazarotene [Taz]~IDP-118 Lotion: Lotion"
11178035|NCT02045277|FG001|Participant Flow|IDP-118 Monad HP Lotion|"HP~IDP-118 Monad HP Lotion: Active Comparator"
11178036|NCT02045277|FG002|Participant Flow|IDP-118 Monad Taz Lotion|"Taz~IDP-118 Monad Taz Lotion: Active Comparator"
11178037|NCT02045277|FG003|Participant Flow|IDP-118 Vehicle Lotion|"Vehicle~IDP-118 Vehicle Lotion: Vehicle"
11178038|NCT02045277|OG000|Outcome|IDP-118 Lotion|"halobetasol propionate [HP], tazarotene [Taz]~IDP-118 Lotion: Lotion"
11178039|NCT02045277|OG001|Outcome|IDP-118 Monad HP Lotion|"HP~IDP-118 Monad HP Lotion: Active Comparator"
11178040|NCT02045277|OG002|Outcome|IDP-118 Monad Taz Lotion|"Taz~IDP-118 Monad Taz Lotion: Active Comparator"
11178041|NCT02045277|OG003|Outcome|IDP-118 Vehicle Lotion|"Vehicle~IDP-118 Vehicle Lotion: Vehicle"
11178042|NCT02045277|EG000|Reported Event|IDP-118 Lotion|"halobetasol propionate [HP], tazarotene [Taz]~IDP-118 Lotion: Lotion"
11178043|NCT02045277|EG001|Reported Event|IDP-118 Monad HP Lotion|"HP~IDP-118 Monad HP Lotion: Active Comparator"
11178044|NCT02045277|EG002|Reported Event|IDP-118 Monad Taz Lotion|"Taz~IDP-118 Monad Taz Lotion: Active Comparator"
11178045|NCT02045277|EG003|Reported Event|IDP-118 Vehicle Lotion|"Vehicle~IDP-118 Vehicle Lotion: Vehicle"
11178046|NCT02045433|BG000|Baseline|Image Guided Hypfractioned Radiation Treatment|"Typically, only 1-5 fractions are used for Image Guided Hypofractionated RadiationTreatment depending on the tolerance of adjacent or intervening normal tissues. Linear structures (like the spinal cord) and tubular structures (like the bowels) are commonly called serially functioning tissues akin to series electrical circuits because their function is disrupted if there is a defect anywhere along their pathways."
11178047|NCT02045433|FG000|Participant Flow|SABR Boost Therapy|SABR Boost Therapy for cervix cancer
11178048|NCT02045433|OG000|Outcome|SABR Boost Therapy|SABR Boost Therapy
11178049|NCT02045433|EG000|Reported Event|SABR Boost Therapy|"SABR Boost Therapy: a. Initial Pelvic (+/- Para-aortic) fractionated external beam Radiation with 45 Gy to combined PTV with a boost to 55Gy for PET positive/CT enlarged nodes; b. Image Guided Hypofractionated Radiation Treatment boost to Cervix High risk CTV/PTV 28GY/4 fx.~Patients will receive 4 fractions of 7 Gy each via stereotactic body radiation as boost therapy to a volume that encompasses the cervical tumor. A minimum of 40 hours should separate each treatment."
11178050|NCT02045511|BG000|Baseline|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11178051|NCT02045511|BG001|Baseline|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11178052|NCT02045511|BG002|Baseline|Total|Total of all reporting groups
11178053|NCT02045511|FG000|Participant Flow|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11178054|NCT02045511|FG001|Participant Flow|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11178055|NCT02045511|OG000|Outcome|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
10949239|NCT00803712|FG001|Participant Flow|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
11178056|NCT02045511|OG001|Outcome|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11178057|NCT02045511|EG000|Reported Event|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11178058|NCT02045511|EG001|Reported Event|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11178059|NCT02045732|BG000|Baseline|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
11178060|NCT02045732|BG001|Baseline|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
11178061|NCT02045732|BG002|Baseline|Total|Total of all reporting groups
11178062|NCT02045732|FG000|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every other week during an 85-day treatment period.
11178063|NCT02045732|FG001|Participant Flow|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 milligram (mg)/kilogram (kg) SC every other week during an 85-day treatment period.
11178064|NCT02045732|OG000|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
11178065|NCT02045732|OG001|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
11178066|NCT02045732|EG000|Reported Event|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
11178067|NCT02045732|EG001|Reported Event|PF-06342674|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
11178068|NCT02045836|BG000|Baseline|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
11178069|NCT02045836|BG001|Baseline|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
10949240|NCT00803712|OG000|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
10949241|NCT00803712|OG001|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
10949242|NCT00803712|EG000|Reported Event|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
10949243|NCT00803712|EG001|Reported Event|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
10949244|NCT00803738|BG000|Baseline|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
10949245|NCT00803738|BG001|Baseline|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
10949246|NCT00803738|BG002|Baseline|Total|Total of all reporting groups
10949247|NCT00803738|FG000|Participant Flow|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
10949248|NCT00803738|FG001|Participant Flow|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
10949249|NCT00803738|OG000|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
10949250|NCT00803738|OG001|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
10949251|NCT00803738|EG000|Reported Event|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
10949252|NCT00803738|EG001|Reported Event|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
10949253|NCT00803751|BG000|Baseline|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
10949254|NCT00803751|BG001|Baseline|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
10949255|NCT00803751|BG002|Baseline|Total|Total of all reporting groups
10949256|NCT00803751|FG000|Participant Flow|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
10949257|NCT00803751|FG001|Participant Flow|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
10949258|NCT00803751|OG000|Outcome|Truview|This group has data for all the truview intubations
10949259|NCT00803751|OG001|Outcome|Mac Blade|This groups has data with all the mac blade intubations
10949260|NCT00803751|EG000|Reported Event|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
10949261|NCT00803751|EG001|Reported Event|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
10949262|NCT00803777|BG000|Baseline|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
10949263|NCT00803777|FG000|Participant Flow|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
10949264|NCT00803777|OG000|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
11178070|NCT02045836|BG002|Baseline|Total|Total of all reporting groups
10949265|NCT00803777|EG000|Reported Event|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
10949266|NCT00803959|BG000|Baseline|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
10949267|NCT00803959|BG001|Baseline|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
10949268|NCT00803959|BG002|Baseline|Total|Total of all reporting groups
10949269|NCT00803959|FG000|Participant Flow|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
10949270|NCT00803959|FG001|Participant Flow|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
10949271|NCT00803959|OG000|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
10949272|NCT00803959|OG001|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
10949273|NCT00803959|EG000|Reported Event|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
10949274|NCT00803959|EG001|Reported Event|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
10949275|NCT00804141|BG000|Baseline|MOA-728 12 mg QD|Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
10949276|NCT00804141|FG000|Participant Flow|MOA-728 12 mg QD|Participants received N-methylnaltrexone bromide (MOA-728, MNTX) 12 milligrams (mg) subcutaneously (SC) once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.
10949277|NCT00804141|OG000|Outcome|MOA-728 12 mg QD|Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
10949278|NCT00804141|EG000|Reported Event|MOA-728 12 mg QD|Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
10949279|NCT00804193|BG000|Baseline|Test Product|Ciclopirox Olamine Topical Suspension
10949280|NCT00804193|BG001|Baseline|Reference Product|Loprox® Topical Suspension 0.77%
10949281|NCT00804193|BG002|Baseline|Vehicle Product|placebo of test product
10949282|NCT00804193|BG003|Baseline|Total|Total of all reporting groups
10949283|NCT00804193|FG000|Participant Flow|Test Product|Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks
10949284|NCT00804193|FG001|Participant Flow|Reference Product|Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks
10949285|NCT00804193|FG002|Participant Flow|Vehicle Product|placebo of test product was applied treatment two times a day for 4 weeks
10949286|NCT00804193|OG000|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
10949287|NCT00804193|OG001|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
10949288|NCT00804193|OG002|Outcome|Vehicle Product|placebo of test product
10949289|NCT00804193|EG000|Reported Event|Test Product|Ciclopirox Olamine Topical Suspension
10949290|NCT00804193|EG001|Reported Event|Reference Product|Loprox® Topical Suspension 0.77%
10949291|NCT00804193|EG002|Reported Event|Vehicle Product|placebo of test product
10949292|NCT00804570|BG000|Baseline|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
10949293|NCT00804570|BG001|Baseline|Placebo|once daily, orally, 16 weeks
10949294|NCT00804570|BG002|Baseline|Total|Total of all reporting groups
10949295|NCT00804570|FG000|Participant Flow|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
10949296|NCT00804570|FG001|Participant Flow|Placebo|once daily, orally, 16 weeks
10949297|NCT00804570|OG000|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
10949298|NCT00804570|OG001|Outcome|Placebo|once daily, orally, 16 weeks
10949299|NCT00804570|OG000|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
10949300|NCT00804570|EG000|Reported Event|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
10949301|NCT00804570|EG001|Reported Event|Placebo|once daily (QD), orally (PO), 16 weeks
10949302|NCT00804596|BG000|Baseline|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
10949303|NCT00804596|FG000|Participant Flow|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
10949304|NCT00804596|OG000|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
10949305|NCT00804596|EG000|Reported Event|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
10949306|NCT00804609|BG000|Baseline|Epidural DepoDur Following Epidural Lidocaine Administration|"Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.~DepoDur: All participant underwent cesarean delivery. An epidural top-up anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.~Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration."
10964074|NCT00875667|OG000|Outcome|Lenalidomide|Participants received lenalidomide 25 mg capsules orally every day for 21 days of each 28-day treatment cycle until disease progression or unacceptable toxicity. Participants with moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but < 60mL/min received 10 mg lenalidomide for 21 days of each 28-day cycle (Cycles 1 and 2). After Cycle 2, if the participant remained free of Grade 3 or Grade 4 toxicity, the dose was increased to 15 mg lenalidomide for 21 days of each 28-day treatment cycle until disease progression or unacceptable toxicity.
10949307|NCT00804609|BG001|Baseline|Epidural DepoDur Following Spinal Anesthetic|"Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.~DepoDur: Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.~Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug."
10949308|NCT00804609|BG002|Baseline|Total|Total of all reporting groups
10949309|NCT00804609|FG000|Participant Flow|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
10949310|NCT00804609|FG001|Participant Flow|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
10949311|NCT00804609|OG000|Outcome|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
10949312|NCT00804609|OG001|Outcome|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
10949313|NCT00804609|EG000|Reported Event|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
10949314|NCT00804609|EG001|Reported Event|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
10949315|NCT00804648|BG000|Baseline|Overall|
10949316|NCT00804648|FG000|Participant Flow|Hemihydrate/Maleate/Maleate Gel|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
10949317|NCT00804648|FG001|Participant Flow|Maleate/Maleate Gel/Hemihydrate|Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
10949318|NCT00804648|FG002|Participant Flow|Maleate Gel/Hemihydrate/Maleate|Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
11178071|NCT02045836|FG000|Participant Flow|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
11178072|NCT02045836|FG001|Participant Flow|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
11178073|NCT02045836|OG000|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
10949319|NCT00804648|FG003|Participant Flow|Hemihydrate/Maleate Gel/Maleate|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
10949320|NCT00804648|FG004|Participant Flow|Maleate/Hemihydrate/Maleate Gel|Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
10949321|NCT00804648|FG005|Participant Flow|Maleate Gel/Maleate/Hemihydrate|Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
10949322|NCT00804648|OG000|Outcome|Timolol Hemihydrate 0.5%|
10949323|NCT00804648|OG001|Outcome|Timolol Maleate 0.5%|
10949324|NCT00804648|OG002|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
10949325|NCT00804648|EG000|Reported Event|Timolol Hemihydrate 0.5%|
10949326|NCT00804648|EG001|Reported Event|Timolol Maleate 0.5%|
10949327|NCT00804648|EG002|Reported Event|Timolol Maleate Gel Forming Solution 0.5%|
10949328|NCT00804687|BG000|Baseline|Entire Study Population|Includes all participants randomized in the study.
10949329|NCT00804687|FG000|Participant Flow|JNJ-39220675 Then Pseudoephedrine Then Placebo|Single-dose of JNJ-39220675 as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 milligram (mg) pseudoephedrine tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
10949330|NCT00804687|FG001|Participant Flow|JNJ-39220675 Then Placebo Then Pseudoephedrine|Single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
10949331|NCT00804687|FG002|Participant Flow|Placebo Then JNJ-39220675 Then Pseudoephedrine|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
10949332|NCT00804687|FG003|Participant Flow|Placebo Then Pseudoephedrine Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
10949333|NCT00804687|FG004|Participant Flow|Pseudoephedrine Then JNJ-39220675 Then Placebo|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
10949334|NCT00804687|FG005|Participant Flow|Pseudoephedrine Then Placebo Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
10949335|NCT00804687|OG000|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
10949336|NCT00804687|OG001|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
10949337|NCT00804687|OG002|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
10949338|NCT00804687|EG000|Reported Event|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
10949339|NCT00804687|EG001|Reported Event|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
11178074|NCT02045836|OG001|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
11178075|NCT02045836|OG000|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .
11178076|NCT02045836|EG000|Reported Event|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
10949340|NCT00804687|EG002|Reported Event|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
10949341|NCT00804843|BG000|Baseline|Statin 80 mg + Niacin ER|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
10949342|NCT00804843|BG001|Baseline|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
10949343|NCT00804843|BG002|Baseline|Total|Total of all reporting groups
10949344|NCT00804843|FG000|Participant Flow|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
10949345|NCT00804843|FG001|Participant Flow|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
10949346|NCT00804843|OG000|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
10949347|NCT00804843|OG001|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
10949348|NCT00804843|OG001|Outcome|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will~receive 10 mg Atorvastatin."
10949349|NCT00804843|EG000|Reported Event|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will recieve 80 mg Atorvastatin + niacin
10949350|NCT00804843|EG001|Reported Event|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will~recieve 10 mg Atorvastatin."
10949351|NCT00804908|BG000|Baseline|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949352|NCT00804908|BG001|Baseline|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949353|NCT00804908|BG002|Baseline|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949354|NCT00804908|BG003|Baseline|Total|Total of all reporting groups
10949355|NCT00804908|FG000|Participant Flow|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949356|NCT00804908|FG001|Participant Flow|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949357|NCT00804908|FG002|Participant Flow|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949358|NCT00804908|OG000|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949359|NCT00804908|OG001|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949360|NCT00804908|OG002|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949361|NCT00804908|EG000|Reported Event|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949362|NCT00804908|EG001|Reported Event|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949363|NCT00804908|EG002|Reported Event|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
10949364|NCT00804973|BG000|Baseline|LY2590443|200 milligrams (mg) administered once as four 50-mg capsules
10949365|NCT00804973|BG001|Baseline|Sumatriptan|6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
10949366|NCT00804973|BG002|Baseline|Placebo|Administered once as 4 capsules or once as an injection of saline solution
10949367|NCT00804973|BG003|Baseline|Total|Total of all reporting groups
10949368|NCT00804973|FG000|Participant Flow|LY2590443|200 milligrams (mg) administered once as four 50-mg capsules
11178077|NCT02045836|EG001|Reported Event|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
10949369|NCT00804973|FG001|Participant Flow|Sumatriptan|6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
10949370|NCT00804973|FG002|Participant Flow|Placebo|Administered once as 4 capsules or once as an injection of saline solution
10949371|NCT00804973|OG000|Outcome|LY2590443|200 milligrams (mg) administered once as four 50-mg capsules
11178078|NCT02045862|BG000|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg once a day for 52 weeks.
11178079|NCT02045862|BG001|Baseline|Solifenacin 5 mg|Participants received solifenacin 5 mg once a day for 52 weeks.
10949372|NCT00804973|OG001|Outcome|Sumatriptan|6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
10949373|NCT00804973|OG002|Outcome|Placebo|Administered once as 4 capsules or once as an injection of saline solution
10949374|NCT00804973|EG000|Reported Event|LY2590443|200 milligrams (mg) administered once as four 50-mg capsules
10949375|NCT00804973|EG001|Reported Event|Sumatriptan|6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
10949376|NCT00804973|EG002|Reported Event|Placebo|Administered once as 4 capsules or once as an injection of saline solution
10949377|NCT00804986|BG000|Baseline|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949378|NCT00804986|BG001|Baseline|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949379|NCT00804986|BG002|Baseline|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949380|NCT00804986|BG003|Baseline|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949381|NCT00804986|BG004|Baseline|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949382|NCT00804986|BG005|Baseline|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949383|NCT00804986|BG006|Baseline|Total|Total of all reporting groups
10949384|NCT00804986|FG000|Participant Flow|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949385|NCT00804986|FG001|Participant Flow|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949386|NCT00804986|FG002|Participant Flow|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949387|NCT00804986|FG003|Participant Flow|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949388|NCT00804986|FG004|Participant Flow|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949389|NCT00804986|FG005|Participant Flow|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949390|NCT00804986|OG000|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
11178080|NCT02045862|BG002|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
11178081|NCT02045862|BG003|Baseline|Total|Total of all reporting groups
11178082|NCT02045862|FG000|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg once a day for 52 weeks.
11178083|NCT02045862|FG001|Participant Flow|Solifenacin 5 mg|Participants received solifenacin 5 mg once a day for 52 weeks.
11178084|NCT02045862|FG002|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
10949391|NCT00804986|OG001|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949392|NCT00804986|OG002|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949393|NCT00804986|OG003|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949394|NCT00804986|OG004|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949395|NCT00804986|OG005|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949396|NCT00804986|EG000|Reported Event|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949397|NCT00804986|EG001|Reported Event|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949398|NCT00804986|EG002|Reported Event|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949399|NCT00804986|EG003|Reported Event|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949400|NCT00804986|EG004|Reported Event|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
10949401|NCT00804986|EG005|Reported Event|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
11178085|NCT02045862|OG000|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg once a day for 52 weeks.
10949402|NCT00804999|BG000|Baseline|Non Contact Lens Wearers Using Clear Care|"neutralized Clear Care and no contact lens wear~Clear Care: neutralized Clear Care"
10949403|NCT00804999|BG001|Baseline|Overnight Soaking With Renu|"ReNu with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution"
11178086|NCT02045862|OG001|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg once a day for 52 weeks.
11178087|NCT02045862|OG002|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
10949404|NCT00804999|BG002|Baseline|Overnight Soaking in Optifree|"RepleniSH with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
10949405|NCT00804999|BG003|Baseline|Overnight Soaking in Optifree Replinish|"ReNu and RepleniSH~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
10949406|NCT00804999|BG004|Baseline|Total|Total of all reporting groups
10949407|NCT00804999|FG000|Participant Flow|Non Contact Wearer Using Clear Care|"neutralized Clear Care and no contact lens wear~Clear Care: neutralized Clear Care"
11178088|NCT02045862|EG000|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg once a day for 52 weeks.
10949408|NCT00804999|FG001|Participant Flow|Overnight Soaking With Renu|"ReNu with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution"
10949409|NCT00804999|FG002|Participant Flow|Overnight Soak in Optifree|"RepleniSH with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
10949410|NCT00804999|FG003|Participant Flow|Overnight Soak in Optifree Replnish|"ReNu and RepleniSH~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
10949411|NCT00804999|OG000|Outcome|Non Contact Wearing Using Clear Care|"neutralized Clear Care and no contact lens wear~Clear Care: neutralized Clear Care"
10949412|NCT00804999|OG001|Outcome|Overnight Soaking With Renu|"ReNu with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution"
10949413|NCT00804999|OG002|Outcome|Overnight Soaking in Optifree|"RepleniSH with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
10949414|NCT00804999|OG003|Outcome|Overnight Soaking in Optifree Replinish|"ReNu and RepleniSH~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
10949415|NCT00804999|EG000|Reported Event|Non Contact Wearing Using Clear Care|"neutralized Clear Care and no contact lens wear~Clear Care: neutralized Clear Care"
10949416|NCT00804999|EG001|Reported Event|Overnight Soaking With Renu|"ReNu with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution"
10949417|NCT00804999|EG002|Reported Event|Overnight Soaking in Optifree|"RepleniSH with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
10949418|NCT00804999|EG003|Reported Event|Overnight Soaking in Optifree Replinish|"ReNu and RepleniSH~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
10949419|NCT00805025|BG000|Baseline|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
11178089|NCT02045862|EG001|Reported Event|Solifenacin 5 mg|Participants received solifenacin 5 mg once a day for 52 weeks.
11178090|NCT02045862|EG002|Reported Event|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
11178091|NCT02045875|BG000|Baseline|Dulera Adherence Monitoring|"Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence~Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older."
10949420|NCT00805025|FG000|Participant Flow|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of aztreonam for inhalation solution (AZLI) 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
10949421|NCT00805025|OG000|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
10949422|NCT00805025|EG000|Reported Event|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
10949423|NCT00805038|BG000|Baseline|Usual Care|Usual care received by participants
10949424|NCT00805038|BG001|Baseline|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
10949425|NCT00805038|BG002|Baseline|Total|Total of all reporting groups
10949426|NCT00805038|FG000|Participant Flow|Usual Care|Usual care received by participants
10949427|NCT00805038|FG001|Participant Flow|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
10949428|NCT00805038|OG000|Outcome|Usual Care|Usual care received by participants
10949429|NCT00805038|OG001|Outcome|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
10949430|NCT00805038|EG000|Reported Event|Usual Care|Usual care received by participants
10949431|NCT00805038|EG001|Reported Event|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
10949432|NCT00805142|BG000|Baseline|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
10949433|NCT00805142|BG001|Baseline|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
10949434|NCT00805142|BG002|Baseline|Total|Total of all reporting groups
10949435|NCT00805142|FG000|Participant Flow|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
10949436|NCT00805142|FG001|Participant Flow|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
10949437|NCT00805142|OG000|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.
10949438|NCT00805142|OG001|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
10949439|NCT00805142|OG000|Outcome|Opioid-Naive Participants Titration Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Treatment was initiated with tapentadol PR 25 mg oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day.
10949440|NCT00805142|OG001|Outcome|Opioid-Switch Participants Titration Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Initial dose of tapentadol PR was selected according to the daily dose of opioid (morphine sustained release (SR) preparation, oxycodone hydrochloride (HCl) SR tablet or fentanyl patch). Equivalent dose of the tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day.
10949441|NCT00805142|OG000|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
10949442|NCT00805142|OG001|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
10949443|NCT00805142|OG001|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
10949444|NCT00805142|OG000|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
10949445|NCT00805142|OG001|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
10949446|NCT00805142|EG000|Reported Event|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
11178092|NCT02045875|BG001|Baseline|Dulera Standard of Asthma Care|"Dulera standard of asthma care~Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older."
11178093|NCT02045875|BG002|Baseline|Total|Total of all reporting groups
11178094|NCT02045875|FG000|Participant Flow|Dulera Adherence Monitoring|"Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence~Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older."
11178095|NCT02045875|FG001|Participant Flow|Dulera Standard of Asthma Care|"Dulera standard of asthma care~Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older."
10949447|NCT00805142|EG001|Reported Event|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
10949448|NCT00805194|BG000|Baseline|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949449|NCT00805194|BG001|Baseline|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949450|NCT00805194|BG002|Baseline|Total|Total of all reporting groups
10949451|NCT00805194|FG000|Participant Flow|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949452|NCT00805194|FG001|Participant Flow|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949453|NCT00805194|OG000|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949454|NCT00805194|OG001|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949455|NCT00805194|OG000|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949456|NCT00805194|OG001|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 (with dose reduction to 60 mg/m2 if required) once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949457|NCT00805194|OG000|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949458|NCT00805194|OG000|Outcome|Nitedanib 200 mg Bid Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949459|NCT00805194|OG001|Outcome|Nintedanib 150 Bid mg Plus Docetaxel|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949460|NCT00805194|EG000|Reported Event|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949461|NCT00805194|EG001|Reported Event|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
10949462|NCT00805207|BG000|Baseline|Testosterone - Premenopausal Women|"Healthy, premenopausal women~Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention"
10949463|NCT00805207|BG001|Baseline|Testosterone - Postmenopausal Women|"Postmenopausal women~Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949464|NCT00805207|BG002|Baseline|Progesterone - PCOS|"Women with obesity and polycystic ovary syndrome~Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention."
10949465|NCT00805207|BG003|Baseline|Progesterone - Postmenopausal Women|"Postmenopausal women~Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention."
10949466|NCT00805207|BG004|Baseline|Continuous Positive Airway Pressure|"Women and men with obesity and obstructive sleep apnea~continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks"
10949467|NCT00805207|BG005|Baseline|Glucocorticoid|"Lean and obese healthy women, and obese men~Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949468|NCT00805207|BG006|Baseline|Estrogen|"Postmenopausal women~Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment."
10949469|NCT00805207|BG007|Baseline|Control|"Postmenopausal women~Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits"
10949470|NCT00805207|BG008|Baseline|Control - Baseline Testing Only|"Healthy men and women~Baseline testing only"
10949471|NCT00805207|BG009|Baseline|Total|Total of all reporting groups
10949472|NCT00805207|FG000|Participant Flow|Progesterone - PCOS|"Women with obesity and polycystic ovary syndrome~Progesterone: Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention."
10949473|NCT00805207|FG001|Participant Flow|Progesterone - Postmenopausal Women|"Postmenopausal women~Progesterone: Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention."
10949474|NCT00805207|FG002|Participant Flow|Testosterone - Premenopausal Women|"Healthy premenopausal women~Testosterone: Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949475|NCT00805207|FG003|Participant Flow|Testosterone - Postmenopausal Women|"Postmenopausal women~Testosterone: Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949476|NCT00805207|FG004|Participant Flow|Continuous Positive Airway Pressure|"Obese women and men with obstructive sleep apnea~continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks"
10949477|NCT00805207|FG005|Participant Flow|Glucocorticoid|"Lean and obese healthy women, and obese men~glucocorticoid: Dexamethasone 0.013 mg/kg fat-free mass daily, 21 days"
10949478|NCT00805207|FG006|Participant Flow|Estrogen|"Postmenopausal women~Estrogens: Estrogen treatment (100 ug Estradiol daily) administered 14 days followed by 14 days without treatment. Repeat this cycle 3 times."
10949479|NCT00805207|FG007|Participant Flow|Control|Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits
11178096|NCT02045875|OG000|Outcome|Dulera Adherence Monitoring|"Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence~Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older."
10949480|NCT00805207|FG008|Participant Flow|Control - Baseline Testing Only|Baseline testing only in pre- and postmenopausal women
10949481|NCT00805207|OG000|Outcome|Testosterone - Premenopausal Women|"Healthy, premenopausal women.~Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949482|NCT00805207|OG001|Outcome|Testosterone - Postmenopausal Women|"Postmenopausal women~Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
11178097|NCT02045875|OG001|Outcome|Dulera Standard of Asthma Care|"Dulera standard of asthma care~Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older."
11178098|NCT02045875|EG000|Reported Event|Dulera Adherence Monitoring|"Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence~Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older."
11178099|NCT02045875|EG001|Reported Event|Dulera Standard of Asthma Care|"Dulera standard of asthma care~Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older."
11178100|NCT02045979|BG000|Baseline|BI 695501|single s.c. injection 40 mg/0.8 mL BI 695501 solution.
11178101|NCT02045979|BG001|Baseline|US-licensed Humira®|single s.c. injection 40 mg/0.8 mL US-licensed Humira®
10949483|NCT00805207|OG002|Outcome|Progesterone - PCOS|"Women with obesity and polycystic ovary syndrome~Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention."
10949484|NCT00805207|OG003|Outcome|Progesterone - Postmenopausal Women|"Postmenopausal women~Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention."
10949485|NCT00805207|OG004|Outcome|Continuous Positive Airway Pressure|"Women and men with obesity and obstructive sleep apnea~Continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks"
10949486|NCT00805207|OG005|Outcome|Glucocorticoid|"Lean and obese healthy women, and obese men~Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949487|NCT00805207|OG006|Outcome|Estrogen|"Postmenopausal women~Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment."
10949488|NCT00805207|OG007|Outcome|Control|"Postmenopausal women~Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits"
10949489|NCT00805207|OG008|Outcome|Control - Baseline Testing Only|"Healthy men and women~Baseline testing only"
10949490|NCT00805207|OG000|Outcome|Testosterone - Premenopausal Women|"Healthy premenopausal women.~Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949491|NCT00805207|OG004|Outcome|Continuous Positive Airway Pressure|"Obese women and men with obstructive sleep apnea~continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks"
10949492|NCT00805207|OG007|Outcome|Control|"Postmenopausal women~Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits"
10949493|NCT00805207|OG004|Outcome|Continuous Positive Airway Pressure|"Women and men with obesity and obstructive sleep apnea~continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks"
10949494|NCT00805207|EG000|Reported Event|Testosterone - Premenopausal Women|"Healthy, premenopausal women.~Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949495|NCT00805207|EG001|Reported Event|Testosterone - Postmenopausal Women|"Postmenopausal women~Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949496|NCT00805207|EG002|Reported Event|Progesterone - PCOS|"Women with obesity and polycystic ovary syndrome~Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention."
10949497|NCT00805207|EG003|Reported Event|Progesterone - Postmenopausal Women|"Postmenopausal women~Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention."
10949498|NCT00805207|EG004|Reported Event|Continuous Positive Airway Pressure|"Obese women and men with obstructive sleep apnea~Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks. Testing is performed before and at the end of the 6 week intervention."
10949499|NCT00805207|EG005|Reported Event|Glucocorticoid|"Lean and obese healthy women, and obese men~Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention."
10949500|NCT00805207|EG006|Reported Event|Estrogen|"Postmenopausal women~Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment."
11178102|NCT02045979|BG002|Baseline|EU-approved Humira®|single s.c. injection 40 mg/0.8 mL EU-approved Humira®
11178103|NCT02045979|BG003|Baseline|Total|Total of all reporting groups
10949501|NCT00805207|EG007|Reported Event|Control|"Postmenopausal women~Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits"
10949502|NCT00805207|EG008|Reported Event|Control - Baseline Testing Only|"Healthy men and women~Baseline testing only"
10949503|NCT00805285|BG000|Baseline|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
10949504|NCT00805285|FG000|Participant Flow|Combination Oral Budesonide and Rectal Hydrocortisone|Budesonide 9 mg po daily and Rectal Hydrocortisone once daily
10949505|NCT00805285|OG000|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
10949506|NCT00805285|EG000|Reported Event|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
10949507|NCT00805389|BG000|Baseline|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949508|NCT00805389|BG001|Baseline|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949509|NCT00805389|BG002|Baseline|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
11178104|NCT02045979|FG000|Participant Flow|BI 695501|Subject to receive a single subcutaneous (s.c.) injection from a prefilled syringe containing 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution.
11178105|NCT02045979|FG001|Participant Flow|US-licensed Humira®|Subject to receive a single subcutaneous (s.c.) injection from a prefilled syringe containing 40 mg/0.8 mL US-licensed Humira®
11178106|NCT02045979|FG002|Participant Flow|EU-approved Humira®|Subject to receive a single subcutaneous (s.c.) injection from a prefilled syringe containing 40 mg/0.8 mL European Union (EU)-approved Humira®.
10949510|NCT00805389|BG003|Baseline|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949511|NCT00805389|BG004|Baseline|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949512|NCT00805389|BG005|Baseline|Total|Total of all reporting groups
10949513|NCT00805389|FG000|Participant Flow|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949514|NCT00805389|FG001|Participant Flow|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949515|NCT00805389|FG002|Participant Flow|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949516|NCT00805389|FG003|Participant Flow|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949517|NCT00805389|FG004|Participant Flow|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949518|NCT00805389|OG000|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
11178107|NCT02045979|OG000|Outcome|BI 695501|single s.c. injection 40 mg/0.8 mL BI 695501 solution.
10949519|NCT00805389|OG001|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949520|NCT00805389|OG002|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
11178108|NCT02045979|OG001|Outcome|US-licensed Humira®|single s.c. injection 40 mg/0.8 mL US-licensed Humira®
11178109|NCT02045979|OG002|Outcome|EU-approved Humira®|single s.c. injection 40 mg/0.8 mL EU-approved Humira®
11178110|NCT02045979|EG000|Reported Event|BI 695501|single s.c. injection 40 mg/0.8 mL BI 695501 solution.
11178111|NCT02045979|EG001|Reported Event|US-licensed Humira®|single s.c. injection 40 mg/0.8 mL US-licensed Humira®
11178112|NCT02045979|EG002|Reported Event|EU-approved Humira®|single s.c. injection 40 mg/0.8 mL EU-approved Humira®
11178113|NCT02046005|BG000|Baseline|General Rheumatoid Arthritis Education|"Arm 1 participants will receive general information about RA.~General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis."
10949521|NCT00805389|OG003|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949522|NCT00805389|OG004|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949523|NCT00805389|OG000|Outcome|GSK223192A 1 - HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
11178114|NCT02046005|BG001|Baseline|PRE-RA|"Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.~PRE-RA: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information."
11178115|NCT02046005|BG002|Baseline|PRE-RA Plus|"Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.~PRE-RA Plus: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator."
11178116|NCT02046005|BG003|Baseline|Total|Total of all reporting groups
10949524|NCT00805389|OG001|Outcome|GSK223192A 2 - HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949525|NCT00805389|OG002|Outcome|GSK223192A 3 - HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949526|NCT00805389|OG003|Outcome|Fendrix - HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949527|NCT00805389|OG004|Outcome|Engerix-B - HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
11178117|NCT02046005|FG000|Participant Flow|General Rheumatoid Arthritis Education|"Arm 1 participants will receive general information about RA.~General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis."
11178118|NCT02046005|FG001|Participant Flow|PRE-RA|"Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.~PRE-RA: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information."
11178119|NCT02046005|FG002|Participant Flow|PRE-RA Plus|"Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.~PRE-RA Plus: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator."
11178120|NCT02046005|OG000|Outcome|General Rheumatoid Arthritis Education|"Arm 1 participants will receive general information about RA.~General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis."
11178121|NCT02046005|OG001|Outcome|PRE-RA|"Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.~PRE-RA: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information."
10949528|NCT00805389|OG000|Outcome|GSK223192A 1 - Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949529|NCT00805389|OG001|Outcome|GSK223192A 2 - Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949530|NCT00805389|OG002|Outcome|GSK223192A 3 - Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949531|NCT00805389|OG003|Outcome|Fendrix - Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949532|NCT00805389|OG004|Outcome|Engerix-B - Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949533|NCT00805389|EG000|Reported Event|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949534|NCT00805389|EG001|Reported Event|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949535|NCT00805389|EG002|Reported Event|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949536|NCT00805389|EG003|Reported Event|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949537|NCT00805389|EG004|Reported Event|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
10949538|NCT00805441|BG000|Baseline|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
10949539|NCT00805441|BG001|Baseline|Placebo|Daily by oral route for 12 weeks.
10949540|NCT00805441|BG002|Baseline|Total|Total of all reporting groups
10949541|NCT00805441|FG000|Participant Flow|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
10949542|NCT00805441|FG001|Participant Flow|Placebo|Daily by oral route for 12 weeks.
10949543|NCT00805441|OG000|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
10949544|NCT00805441|OG001|Outcome|Placebo|Daily by oral route for 12 weeks.
10949545|NCT00805441|EG000|Reported Event|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
10949546|NCT00805441|EG001|Reported Event|Placebo|Daily by oral route for 12 weeks.
10949547|NCT00805467|BG000|Baseline|Fostamatinib 50 mg Bid|Oral treatment
10949548|NCT00805467|BG001|Baseline|Fostamatinib 100 mg qd|Oral treatment
10949549|NCT00805467|BG002|Baseline|Fostamatinib 150 mg qd|Oral treatment
10949550|NCT00805467|BG003|Baseline|Fostamatinib 100 mg Bid|Oral treatment
10949551|NCT00805467|BG004|Baseline|Total|Total of all reporting groups
10949552|NCT00805467|FG000|Participant Flow|Fostamatinib 50 mg Bid|Oral treatment
10949553|NCT00805467|FG001|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
10949554|NCT00805467|FG002|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
10949555|NCT00805467|FG003|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
10949556|NCT00805467|OG000|Outcome|Fostamatinib 50 mg Bid|Oral treatment
10949557|NCT00805467|OG001|Outcome|Fostamatinib 100 mg qd|Oral treatment
10949558|NCT00805467|OG002|Outcome|Fostamatinib 150 mg qd|Oral treatment
10949559|NCT00805467|OG003|Outcome|Fostamatinib 100 mg Bid|Oral treatment
10949560|NCT00805467|EG000|Reported Event|100 MG BID|
10949561|NCT00805467|EG001|Reported Event|100 MG QD|
10949562|NCT00805467|EG002|Reported Event|150 MG QD|
10949563|NCT00805467|EG003|Reported Event|50 MG BID|
10949564|NCT00805480|BG000|Baseline|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
10949565|NCT00805480|BG001|Baseline|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
10949566|NCT00805480|BG002|Baseline|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
10949567|NCT00805480|BG003|Baseline|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
10949568|NCT00805480|BG004|Baseline|Total|Total of all reporting groups
10949569|NCT00805480|FG000|Participant Flow|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
10949570|NCT00805480|FG001|Participant Flow|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
10949571|NCT00805480|FG002|Participant Flow|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
10949572|NCT00805480|FG003|Participant Flow|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
10949573|NCT00805480|OG000|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
10949574|NCT00805480|OG001|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
10949575|NCT00805480|OG002|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
10949576|NCT00805480|OG003|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
10949577|NCT00805480|EG000|Reported Event|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
10949578|NCT00805480|EG001|Reported Event|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
10949579|NCT00805480|EG002|Reported Event|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
10949580|NCT00805480|EG003|Reported Event|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
10949581|NCT00805493|BG000|Baseline|Riluzole|
10949582|NCT00805493|BG001|Baseline|Placebo|
10949583|NCT00805493|BG002|Baseline|Not Randomized|
10949584|NCT00805493|BG003|Baseline|Total|Total of all reporting groups
10949585|NCT00805493|FG000|Participant Flow|Riluzole|Those randomized to riluzole
10949586|NCT00805493|FG001|Participant Flow|Placebo|Those randomized to receive placebo
10949587|NCT00805493|FG002|Participant Flow|Not Randomized|Those who withdrew prior to the decision to randomize
10949588|NCT00805493|OG000|Outcome|Riluzole|The group randomized to riluzole
10949589|NCT00805493|OG001|Outcome|Placebo|
10949590|NCT00805493|OG002|Outcome|Not Randomized|Those who withdrew prior to the decision to randomize
10949591|NCT00805493|OG000|Outcome|Placebo|The group randomized to receive placebo
10949592|NCT00805493|OG001|Outcome|Not Randomized|Participants who withdrew prior to the decision to randomize
10949593|NCT00805493|OG002|Outcome|Riluzole|The group randomized to receive riluzole
10949594|NCT00805493|EG000|Reported Event|Riluzole|
10949595|NCT00805493|EG001|Reported Event|Placebo|
10949596|NCT00805493|EG002|Reported Event|Not Randomized|
10949597|NCT00805532|BG000|Baseline|Behavioral Activation (BA)|
10949598|NCT00805532|BG001|Baseline|Treatment as Usual (TAU)|
10949599|NCT00805532|BG002|Baseline|Total|Total of all reporting groups
10949600|NCT00805532|FG000|Participant Flow|Behavioral Activation (BA)|Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.
10949601|NCT00805532|FG001|Participant Flow|Treatment as Usual (TAU)|"Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based coping skills treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments."
10949602|NCT00805532|OG000|Outcome|Behavioral Activation|"Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in to address PTSD-related problems.~Behavioral Activation treatment: Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems."
10949603|NCT00805532|OG001|Outcome|Treatment as Usual|"Treatment As Usual for PTSD (TAU)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to TAU will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.~Treatment as Usual: Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy."
11341761|NCT03687827|BG000|Baseline|Overall Study|Participants were to receive subcutaneous (s.c.) injection of Insulin degludec 100U/mL once daily followed by a s.c. injection of Insulin glargine 100U/mL once daily in 2 treatment periods with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
10949604|NCT00805532|OG000|Outcome|Behavioral Activation (BA)|Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.
10949605|NCT00805532|OG001|Outcome|Treatment as Usual (TAU)|"Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based coping skills treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments."
10949606|NCT00805532|EG000|Reported Event|Behavioral Activation (BA)|Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.
10949607|NCT00805532|EG001|Reported Event|Treatment as Usual (TAU)|"Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based coping skills treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments."
10949608|NCT00805545|BG000|Baseline|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
10949609|NCT00805545|BG001|Baseline|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
10949610|NCT00805545|BG002|Baseline|Total|Total of all reporting groups
10949611|NCT00805545|FG000|Participant Flow|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
10949612|NCT00805545|FG001|Participant Flow|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
10949613|NCT00805545|OG000|Outcome|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
10949614|NCT00805545|OG001|Outcome|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
10949615|NCT00805545|EG000|Reported Event|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
10949616|NCT00805545|EG001|Reported Event|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
10949617|NCT00805675|BG000|Baseline|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949618|NCT00805675|BG001|Baseline|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949619|NCT00805675|BG002|Baseline|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949620|NCT00805675|BG003|Baseline|Total|Total of all reporting groups
10949621|NCT00805675|FG000|Participant Flow|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949622|NCT00805675|FG001|Participant Flow|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949623|NCT00805675|FG002|Participant Flow|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949624|NCT00805675|OG000|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949625|NCT00805675|OG001|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949626|NCT00805675|OG002|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949627|NCT00805675|EG000|Reported Event|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949628|NCT00805675|EG001|Reported Event|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949629|NCT00805675|EG002|Reported Event|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
10949630|NCT00805740|BG000|Baseline|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
10949631|NCT00805740|BG001|Baseline|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
10949632|NCT00805740|BG002|Baseline|Total|Total of all reporting groups
10949633|NCT00805740|FG000|Participant Flow|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
10949634|NCT00805740|FG001|Participant Flow|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
10949635|NCT00805740|OG000|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
10949636|NCT00805740|OG001|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
10949637|NCT00805740|EG000|Reported Event|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
10949638|NCT00805740|EG001|Reported Event|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
10949639|NCT00805766|BG000|Baseline|TA-650|
10949640|NCT00805766|FG000|Participant Flow|TA-650|"Screening period: From the beginning of TA-650 5 mg/kg administration to the beginning of TA-650 10 mg/kg administration in the increased dose period in order to confirm that the effects of treatment with TA-650 5 mg/kg at 8-week intervals were insufficient. The screening period was to be up to 16 weeks. Patients who did not satisfy the dose-increasing criteria discontinued study treatment.Patients who discontinued study treatment during the screening period were to be evaluated until withdrawal.~Increased dose period: From the beginning of administration of TA-650 10 mg/kg to evaluation at week 40. Patients who discontinued study treatment during the increased dose period were to be evaluated until withdrawal."
10949641|NCT00805766|OG000|Outcome|TA-650|
10949642|NCT00805766|OG000|Outcome|Screening Period|
10949643|NCT00805766|OG001|Outcome|Increased Dose Period|
10949644|NCT00805766|EG000|Reported Event|Entire Evaluation Period|Screening Period + Increased Dose Period
11178122|NCT02046005|OG002|Outcome|PRE-RA Plus|"Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.~PRE-RA Plus: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator."
11178123|NCT02046005|EG000|Reported Event|General Rheumatoid Arthritis Education|"Arm 1 participants will receive general information about RA.~General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis."
10949645|NCT00805766|EG001|Reported Event|Screening Period|
11178124|NCT02046005|EG001|Reported Event|PRE-RA|"Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.~PRE-RA: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information."
11178125|NCT02046005|EG002|Reported Event|PRE-RA Plus|"Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.~PRE-RA Plus: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator."
11178126|NCT02046070|BG000|Baseline|Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity [13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months] and cyclophosphamide (CYC) 300 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
10949646|NCT00805766|EG002|Reported Event|Increased Dose Period|
10949647|NCT00805792|BG000|Baseline|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
10949648|NCT00805792|FG000|Participant Flow|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
10949649|NCT00805792|OG000|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
10949650|NCT00805792|EG000|Reported Event|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
10949651|NCT00805870|BG000|Baseline|Fish Oil|Lovaza, 3 grams/day for 65 days
10949652|NCT00805870|BG001|Baseline|Control|Wheat Germ Oil, 3 grams/day for 65 days
10949653|NCT00805870|BG002|Baseline|Total|Total of all reporting groups
10949654|NCT00805870|FG000|Participant Flow|Fish Oil|Lovaza, 3 grams/day for 65 days
10949655|NCT00805870|FG001|Participant Flow|Control|Wheat Germ Oil, 3 grams/day for 65 days
10949656|NCT00805870|OG000|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
10949657|NCT00805870|OG001|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
10949658|NCT00805870|EG000|Reported Event|Fish Oil|Lovaza, 3 grams/day for 65 days
10949659|NCT00805870|EG001|Reported Event|Control|Wheat Germ Oil, 3 grams/day for 65 days
10949660|NCT00805935|BG000|Baseline|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949661|NCT00805935|BG001|Baseline|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949662|NCT00805935|BG002|Baseline|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949663|NCT00805935|BG003|Baseline|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949664|NCT00805935|BG004|Baseline|Total|Total of all reporting groups
10949665|NCT00805935|FG000|Participant Flow|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949666|NCT00805935|FG001|Participant Flow|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949667|NCT00805935|FG002|Participant Flow|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949668|NCT00805935|FG003|Participant Flow|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949669|NCT00805935|OG000|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949670|NCT00805935|OG001|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949671|NCT00805935|OG002|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949672|NCT00805935|OG003|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949673|NCT00805935|OG000|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
10949674|NCT00805935|OG001|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
10949675|NCT00805935|EG000|Reported Event|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949676|NCT00805935|EG001|Reported Event|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949677|NCT00805935|EG002|Reported Event|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949678|NCT00805935|EG003|Reported Event|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
10949679|NCT00805948|BG000|Baseline|De Novo Group|154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
10949680|NCT00805948|BG001|Baseline|Valor Test Group|195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
10949681|NCT00805948|BG002|Baseline|Total|Total of all reporting groups
10949682|NCT00805948|FG000|Participant Flow|De Novo Group|154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
10949683|NCT00805948|FG001|Participant Flow|Valor Test Group|195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
10949684|NCT00805948|OG000|Outcome|All Subjects|All Subjects (349) is comprised of 195 subjects from the VALOR Test Group (PMA P070007) and 154 of the planned 256 De Novo subjects.
10949685|NCT00805948|OG000|Outcome|De Novo Group|154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
10949686|NCT00805948|OG001|Outcome|Valor Test Group|195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
10949687|NCT00805948|EG000|Reported Event|De Novo Group|154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
10949688|NCT00805948|EG001|Reported Event|Valor Test Group|195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
10949689|NCT00806026|BG000|Baseline|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949690|NCT00806026|BG001|Baseline|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
10949691|NCT00806026|BG002|Baseline|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949692|NCT00806026|BG003|Baseline|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949693|NCT00806026|BG004|Baseline|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
10949694|NCT00806026|BG005|Baseline|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949695|NCT00806026|BG006|Baseline|Total|Total of all reporting groups
10949696|NCT00806026|FG000|Participant Flow|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949697|NCT00806026|FG001|Participant Flow|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
10949698|NCT00806026|FG002|Participant Flow|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949699|NCT00806026|FG003|Participant Flow|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949700|NCT00806026|FG004|Participant Flow|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
10949701|NCT00806026|FG005|Participant Flow|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949702|NCT00806026|OG000|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949703|NCT00806026|OG001|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
10949704|NCT00806026|OG002|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949705|NCT00806026|OG003|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
11178127|NCT02046070|BG001|Baseline|Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity [13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months] and cyclophosphamide (CYC) 400 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
11178128|NCT02046070|BG002|Baseline|Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
11178129|NCT02046070|BG003|Baseline|Total|Total of all reporting groups
10949706|NCT00806026|EG000|Reported Event|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949707|NCT00806026|EG001|Reported Event|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
11192223|NCT02137837|OG000|Outcome|Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)~Fulvestrant~Everolimus~Placebo - Anastrozole"
10949708|NCT00806026|EG002|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949709|NCT00806026|EG003|Reported Event|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949710|NCT00806026|EG004|Reported Event|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
10949711|NCT00806026|EG005|Reported Event|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
10949712|NCT00806078|BG000|Baseline|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
10949713|NCT00806078|BG001|Baseline|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
10949714|NCT00806078|BG002|Baseline|Total|Total of all reporting groups
10949715|NCT00806078|FG000|Participant Flow|Quinine Alone First|Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) as intact capsules after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize quinine pharmacokinetics after this dose. Following a 7 day wash out period, all participants were given quinine 648 mg (2 x 324 mg) as capsules opened and their contents mixed in 120 mL chocolate pudding under similar conditions.
10949716|NCT00806078|FG001|Participant Flow|Quinine With Chocolate Pudding First|Participants were randomized to receive a single dose of Quinine 648 mg (2 x 324 mg capsules) opened and mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. Following a 7 day wash out period, all participants were given Quinine 648 mg (2 x 324 mg) as intact capsules under similar conditions.
10949717|NCT00806078|OG000|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
11178130|NCT02046070|FG000|Participant Flow|Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity [13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months] and cyclophosphamide (CYC) 300 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
11178131|NCT02046070|FG001|Participant Flow|Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity [13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months] and cyclophosphamide (CYC) 400 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
10949718|NCT00806078|OG001|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
10949719|NCT00806078|EG000|Reported Event|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
10949720|NCT00806078|EG001|Reported Event|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
10949721|NCT00806156|BG000|Baseline|NKTR-102 q14d|"NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites."
10949722|NCT00806156|BG001|Baseline|NKTR-102 q21d|"NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites."
10949723|NCT00806156|BG002|Baseline|Total|Total of all reporting groups
10949724|NCT00806156|FG000|Participant Flow|NKTR-102 q14d|NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.
10949725|NCT00806156|FG001|Participant Flow|NKTR-102 q21d|NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.
10949726|NCT00806156|OG000|Outcome|NKTR-102 q21d|"NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites."
10949727|NCT00806156|OG001|Outcome|Primary Efficacy Population|The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
10949728|NCT00806156|OG000|Outcome|NKTR-102 q14d|"NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites."
10949729|NCT00806156|OG001|Outcome|NKTR-102 q21d|"NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites."
10949730|NCT00806156|OG002|Outcome|MITT Population|The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
10949731|NCT00806156|OG001|Outcome|Primary Efficacy Population|Patients in the MITT Population treated in q21d treatment schedule with platinum-resistant ovarian cancer, had received prior PLD therapy in a platinum-resistant setting or who were otherwise unable to receive further PLD therapy.
10949732|NCT00806156|OG000|Outcome|NKTR-102 q14d|"NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites."
10949733|NCT00806156|OG002|Outcome|Platinum-Refractory Population|Patients in the MITT Population with a PFI ≤ 6 weeks.
10949734|NCT00806156|OG002|Outcome|Prior PLD Population|Patients in the MITT Population treated in q14d and q21d treatment schedules, who subsequently progressed after receiving PLD therapy or who were otherwise unable to receive PLD therapy.
10949735|NCT00806156|OG000|Outcome|NKTR-102 q21d|"NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.."
10949736|NCT00806156|OG001|Outcome|Primary Efficacy Population|The primary efficacy population consisted of patients with platinum-resistant ovarian cancer in the modified intent-to-treat population (MITT) treated in q21d treatment schedule who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
10949737|NCT00806156|OG001|Outcome|Primary Efficacy Population|The primary efficacy population only included subjects treated in the NKTR-102 q21d treatment arm.
10949738|NCT00806156|OG000|Outcome|NKTR-102 q14d|"NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites and shortly thereafter included in Protocol Amendment 1.0 dated 26 Mar 2009."
10949739|NCT00806156|OG001|Outcome|NKTR-102 q21d|"NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites and shortly thereafter included in Protocol Amendment 1.0 dated 26 Mar 2009."
10949740|NCT00806156|EG000|Reported Event|NKTR-102 q14d|"NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites."
10949741|NCT00806156|EG001|Reported Event|NKTR-102 q21d|"NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.~Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites."
10949742|NCT00806195|BG000|Baseline|MenACWY-CRM197 + Routine Vaccines (Non-Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
10949743|NCT00806195|BG001|Baseline|Routine Vaccines (Non-Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
10949744|NCT00806195|BG002|Baseline|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
10949745|NCT00806195|BG003|Baseline|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
10949746|NCT00806195|BG004|Baseline|Total|Total of all reporting groups
10949747|NCT00806195|FG000|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Non-detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE)."
10949748|NCT00806195|FG001|Participant Flow|Routine Vaccines (Non-detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
11178132|NCT02046070|FG002|Participant Flow|Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
10949749|NCT00806195|FG002|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
10949750|NCT00806195|FG003|Participant Flow|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs."
10949751|NCT00806195|OG000|Outcome|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
10949752|NCT00806195|OG001|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
10949753|NCT00806195|OG000|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
10949754|NCT00806195|OG001|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
10949755|NCT00806195|OG000|Outcome|MenACWY-CRM 197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
10949756|NCT00806195|OG001|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
10949757|NCT00806195|OG000|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
11178133|NCT02046070|OG000|Outcome|Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity [13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months] and cyclophosphamide (CYC) 300 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
10949758|NCT00806195|OG001|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
10949759|NCT00806195|EG000|Reported Event|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
10949760|NCT00806195|EG001|Reported Event|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
10949761|NCT00806221|BG000|Baseline|Emollient|"Skin barrier protection from birth~emollient (Cetaphil cream): Cetaphil cream applied daily from birth"
10949762|NCT00806221|FG000|Participant Flow|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
10949763|NCT00806221|OG000|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
10949764|NCT00806221|EG000|Reported Event|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
11178134|NCT02046070|OG001|Outcome|Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity [13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months] and cyclophosphamide (CYC) 400 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
11178135|NCT02046070|OG000|Outcome|Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
11178136|NCT02046070|EG000|Reported Event|Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity [13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months] and cyclophosphamide (CYC) 300 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
10949765|NCT00806234|BG000|Baseline|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
10949766|NCT00806234|BG001|Baseline|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
10949767|NCT00806234|BG002|Baseline|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
10949768|NCT00806234|BG003|Baseline|Total|Total of all reporting groups
10949769|NCT00806234|FG000|Participant Flow|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
10949770|NCT00806234|FG001|Participant Flow|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
10949771|NCT00806234|FG002|Participant Flow|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
11178137|NCT02046070|EG001|Reported Event|Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity [13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months] and cyclophosphamide (CYC) 400 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
11178138|NCT02046070|EG002|Reported Event|Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients >75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
11178139|NCT02046122|BG000|Baseline|Idarubicin + Cytarabine + DLI|"Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI)~Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.~Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy.~Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.~Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after"
10949772|NCT00806234|OG000|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
10949773|NCT00806234|OG001|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
10949774|NCT00806234|OG002|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
10949775|NCT00806234|EG000|Reported Event|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
10949776|NCT00806234|EG001|Reported Event|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
10949777|NCT00806234|EG002|Reported Event|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
10949778|NCT00806260|BG000|Baseline|Alcohol, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol in period 1, VI-0521 placebo in period 2 and VI-0521 in period 3.
10949779|NCT00806260|BG001|Baseline|Alcohol, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol in period 1, VI-0521 in period 2 and VI-0521-placebo in period 3.
10949780|NCT00806260|BG002|Baseline|Alcohol Placebo, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol placebo in period 1, VI-0521-placebo in period 2 and VI-0521 in period 3.
10949781|NCT00806260|BG003|Baseline|Alcohol Placebo, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol placebo in period 1, VI-0521 in period 2 and VI-0521 placebo in period 3.
10949782|NCT00806260|BG004|Baseline|Alcohol Only|Subjects in this study arm only participated in period 1 and were given alcohol.
10949783|NCT00806260|BG005|Baseline|Alcohol Placebo Only|Subject in this study arm only participated in period 1 and were given alcohol placebo.
10949784|NCT00806260|BG006|Baseline|Total|Total of all reporting groups
10949785|NCT00806260|FG000|Participant Flow|Alcohol, VI-0521 Placebo Then VI-0521|Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
10949786|NCT00806260|FG001|Participant Flow|Alcohol, VI-0521 Then VI-0521 Placebo|Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
10949787|NCT00806260|FG002|Participant Flow|Alcohol-placebo, VI-0521-placebo Then VI-0521|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
10949788|NCT00806260|FG003|Participant Flow|Alcohol-placebo, VI-0521 Then VI-0521-placebo|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
10949789|NCT00806260|FG004|Participant Flow|Alcohol Only|Alcohol was administered during period one after which the subject's participation ended.
10949790|NCT00806260|FG005|Participant Flow|Alcohol-placebo Only|Alcohol-placebo was administered during period one after which the subject's participation ended.
10949791|NCT00806260|OG000|Outcome|Period 1 Alcohol-placebo|fruit juice
10949792|NCT00806260|OG001|Outcome|Period 1 Alcohol|Alcohol
10949793|NCT00806260|OG000|Outcome|Period 2 VI-0521-placebo|Placebo
10949794|NCT00806260|OG001|Outcome|Period 2 VI-0521|phentermine/topiramate
10949795|NCT00806260|OG002|Outcome|Period 3 VI-0521-placebo|placebo
10949796|NCT00806260|OG003|Outcome|Period 3 VI-0521|phentermine/topiramate
10949797|NCT00806260|EG000|Reported Event|Period 1 Placebo|
10949798|NCT00806260|EG001|Reported Event|Period 1 Alcohol|
10949799|NCT00806260|EG002|Reported Event|Period 2 and 3 Placebo|Total number of subjects that were given VI-0521 placebo was 43. 1 subject was excluded from the analysis due to failing a drug/alcohol screen leaving 42 subjects in the ITT population.
10949800|NCT00806260|EG003|Reported Event|Period 2 and 3 Qnexa|The total number of subjects that were given VI-0521 was 41. 2 subjects were excluded from the analysis, one due to failing a drug/alcohol screen and the other due to pregnancy. Excluding these two subjects leaves 39 subjects in the analyzed ITT population.
10949801|NCT00806286|BG000|Baseline|CS7017+Carboplatin+Paclitaxel|Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).
10949802|NCT00806286|BG001|Baseline|CS7017-matching Placebo+Carboplatin+Paclitaxel|Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).
10949803|NCT00806286|BG002|Baseline|Safety Portion|Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
10949804|NCT00806286|BG003|Baseline|Total|Total of all reporting groups
10949805|NCT00806286|FG000|Participant Flow|CS7017+Carboplatin+Paclitaxel|Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).
10949806|NCT00806286|FG001|Participant Flow|CS7017-matching Placebo+Carboplatin+Paclitaxel|Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).
10949807|NCT00806286|FG002|Participant Flow|Safety Portion|Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
10949808|NCT00806286|OG000|Outcome|CS7017+Carboplatin+Paclitaxel|Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).
10949809|NCT00806286|OG001|Outcome|CS7017-matching Placebo+Carboplatin+Paclitaxel|Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).
10949810|NCT00806286|OG002|Outcome|Safety Portion|Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
10949811|NCT00806286|EG000|Reported Event|CS7017+Carboplatin+Paclitaxel|Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).
10949812|NCT00806286|EG001|Reported Event|CS7017-matching Placebo+Carboplatin+Paclitaxel|Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).
10949813|NCT00806286|EG002|Reported Event|Safety Portion|Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
10949814|NCT00806351|BG000|Baseline|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
10949815|NCT00806351|BG001|Baseline|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
10949816|NCT00806351|BG002|Baseline|Total|Total of all reporting groups
11192224|NCT02137837|OG002|Outcome|Arm 3: Fulvestrant + Everolimus + Anastrozole|"Participants receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)~Fulvestrant~Anastrozole~Everolimus"
10949817|NCT00806351|FG000|Participant Flow|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
10949818|NCT00806351|FG001|Participant Flow|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
10949819|NCT00806351|OG000|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
10949820|NCT00806351|OG001|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
10949821|NCT00806351|EG000|Reported Event|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
10949822|NCT00806351|EG001|Reported Event|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
10949823|NCT00806442|BG000|Baseline|All Study Particpants|Includes patients scheduled to receive Borage and Echium seed oil first and participants scheduled to receive placebo first.
10949824|NCT00806442|FG000|Participant Flow|1 - Borage Seed Oil and Echium Seed Oil, Then Placebo|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks followed a 3-week washout period, then Placebo (11 g/day corn oil) 3x day for 3 weeks.
10949825|NCT00806442|FG001|Participant Flow|2 - Placebo, Then Borage Seed Oil and Echium Seed Oil|Placebo (11 g of corn oil/day) 3x day for 3 weeks followed by a 3-week washout period, then Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks.
10949826|NCT00806442|OG000|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
10949827|NCT00806442|OG001|Outcome|Placebo|Placebo (11 g of corn oil/day)
10949828|NCT00806442|EG000|Reported Event|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
10949829|NCT00806442|EG001|Reported Event|Placebo|Placebo (11 g of corn oil/day)
10949830|NCT00806442|EG002|Reported Event|Washout After Plant Seed Oil|Washout period between first (plant seed oil) and second (placebo) treatment assignments
10949831|NCT00806442|EG003|Reported Event|Washout After Placebo|Washout period between first (placebo) and second (plant seed oil) treatment assignments
10949832|NCT00806494|BG000|Baseline|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
10949833|NCT00806494|FG000|Participant Flow|Fesoterodine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
10949834|NCT00806494|OG000|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
10949835|NCT00806494|OG000|Outcome|Fesoteridine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
10949836|NCT00806494|EG000|Reported Event|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
10949837|NCT00806546|BG000|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
10949838|NCT00806546|FG000|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
10949839|NCT00806546|OG000|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
10949840|NCT00806546|EG000|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
10949841|NCT00806585|BG000|Baseline|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
10949842|NCT00806585|BG001|Baseline|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
10949843|NCT00806585|BG002|Baseline|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
10949844|NCT00806585|BG003|Baseline|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
10949845|NCT00806585|BG004|Baseline|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
10949846|NCT00806585|BG005|Baseline|Total|Total of all reporting groups
10949847|NCT00806585|FG000|Participant Flow|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
10949848|NCT00806585|FG001|Participant Flow|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
10949849|NCT00806585|FG002|Participant Flow|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
10949850|NCT00806585|FG003|Participant Flow|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
10949851|NCT00806585|FG004|Participant Flow|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
10949852|NCT00806585|OG000|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
10949853|NCT00806585|OG001|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
10949854|NCT00806585|OG002|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
10949855|NCT00806585|OG003|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
10949856|NCT00806585|OG004|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
10949857|NCT00806585|EG000|Reported Event|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
10949858|NCT00806585|EG001|Reported Event|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
10949859|NCT00806585|EG002|Reported Event|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
10949860|NCT00806585|EG003|Reported Event|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
10949861|NCT00806585|EG004|Reported Event|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
10963646|NCT00873093|OG000|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
10963647|NCT00873093|OG001|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
10963648|NCT00873093|OG002|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
10963649|NCT00873093|OG003|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
10963650|NCT00873093|OG004|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
10963651|NCT00873093|OG000|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
11240760|NCT02481596|BG001|Baseline|REACH|"Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors).~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions."
10949862|NCT00806598|BG000|Baseline|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
10949863|NCT00806598|FG000|Participant Flow|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
10949864|NCT00806598|OG000|Outcome|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + Granulocyte Colony stimulating factor (G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
10949865|NCT00806598|EG000|Reported Event|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
10949866|NCT00806624|BG000|Baseline|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
10949867|NCT00806624|BG001|Baseline|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
10949868|NCT00806624|BG002|Baseline|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
10949869|NCT00806624|BG003|Baseline|Total|Total of all reporting groups
10949870|NCT00806624|FG000|Participant Flow|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
10949871|NCT00806624|FG001|Participant Flow|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
10949872|NCT00806624|FG002|Participant Flow|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
11178140|NCT02046122|FG000|Participant Flow|Idarubicin + Cytarabine + DLI|"Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI)~Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.~Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy.~Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.~Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after"
11192225|NCT02137837|OG000|Outcome|Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)~Fulvestrant~Placebo - Anastrozole~Placebo - Everolimus"
10949873|NCT00806624|OG000|Outcome|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
10949874|NCT00806624|OG001|Outcome|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
10949875|NCT00806624|OG002|Outcome|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
10949876|NCT00806624|EG000|Reported Event|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
10949877|NCT00806624|EG001|Reported Event|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
10949878|NCT00806624|EG002|Reported Event|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
10949879|NCT00806676|BG000|Baseline|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949880|NCT00806676|BG001|Baseline|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949881|NCT00806676|BG002|Baseline|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949882|NCT00806676|BG003|Baseline|Total|Total of all reporting groups
10949883|NCT00806676|FG000|Participant Flow|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949884|NCT00806676|FG001|Participant Flow|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949885|NCT00806676|FG002|Participant Flow|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949886|NCT00806676|OG000|Outcome|HPV 6|HPV genotype
10949887|NCT00806676|OG001|Outcome|HPV 11|
10949888|NCT00806676|OG002|Outcome|HPV 16|
10949889|NCT00806676|OG003|Outcome|HPV 18|
10949890|NCT00806676|EG000|Reported Event|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949891|NCT00806676|EG001|Reported Event|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949892|NCT00806676|EG002|Reported Event|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
10949893|NCT00806819|BG000|Baseline|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10949894|NCT00806819|BG001|Baseline|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10949895|NCT00806819|BG002|Baseline|Total|Total of all reporting groups
10949896|NCT00806819|FG000|Participant Flow|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10949897|NCT00806819|FG001|Participant Flow|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10949898|NCT00806819|OG000|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10949899|NCT00806819|OG001|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10949900|NCT00806819|OG001|Outcome|Nintedanib 150 mg Bid Plus Pemetrexed|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.
10949901|NCT00806819|EG000|Reported Event|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10949902|NCT00806819|EG001|Reported Event|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10949903|NCT00806988|BG000|Baseline|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
10949904|NCT00806988|BG001|Baseline|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
10949905|NCT00806988|BG002|Baseline|Total|Total of all reporting groups
10949906|NCT00806988|FG000|Participant Flow|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
10949907|NCT00806988|FG001|Participant Flow|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
10949908|NCT00806988|OG000|Outcome|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
11240761|NCT02481596|BG002|Baseline|Helpline & A1c Results|"Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions."
11240762|NCT02481596|BG003|Baseline|Total|Total of all reporting groups
10949909|NCT00806988|OG001|Outcome|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
10949910|NCT00806988|EG000|Reported Event|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
10949911|NCT00806988|EG001|Reported Event|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
10949912|NCT00807001|BG000|Baseline|Placebo|
10949913|NCT00807001|BG001|Baseline|IDX184 25 mg|
10949914|NCT00807001|BG002|Baseline|IDX184 50 mg|
10949915|NCT00807001|BG003|Baseline|IDX184 75 mg|
10949916|NCT00807001|BG004|Baseline|IDX184 100 mg|
10949917|NCT00807001|BG005|Baseline|Total|Total of all reporting groups
10949918|NCT00807001|FG000|Participant Flow|Placebo|
10949919|NCT00807001|FG001|Participant Flow|IDX184 25 mg|
10949920|NCT00807001|FG002|Participant Flow|IDX184 50 mg|
10949921|NCT00807001|FG003|Participant Flow|IDX184 75 mg|
10949922|NCT00807001|FG004|Participant Flow|IDX184 100 mg|
10949923|NCT00807001|OG000|Outcome|Placebo|
10949924|NCT00807001|OG001|Outcome|IDX184 25 mg|
10949925|NCT00807001|OG002|Outcome|IDX184 50 mg|
10949926|NCT00807001|OG003|Outcome|IDX184 75 mg|
10949927|NCT00807001|OG004|Outcome|IDX184 100 mg|
10949928|NCT00807001|EG000|Reported Event|Placebo|
10949929|NCT00807001|EG001|Reported Event|IDX184 25 mg|
10949930|NCT00807001|EG002|Reported Event|IDX184 50 mg|
10949931|NCT00807001|EG003|Reported Event|IDX184 75 mg|
10949932|NCT00807001|EG004|Reported Event|IDX184 100 mg|
10949933|NCT00807014|BG000|Baseline|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
10949934|NCT00807014|BG001|Baseline|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
10949935|NCT00807014|BG002|Baseline|Total|Total of all reporting groups
10949936|NCT00807014|FG000|Participant Flow|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
10949937|NCT00807014|FG001|Participant Flow|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
10949938|NCT00807014|OG000|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
10949939|NCT00807014|OG001|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
10949940|NCT00807014|EG000|Reported Event|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
10949941|NCT00807014|EG001|Reported Event|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
10949942|NCT00807040|BG000|Baseline|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
10949943|NCT00807040|BG001|Baseline|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
10949944|NCT00807040|BG002|Baseline|Total|Total of all reporting groups
10949945|NCT00807040|FG000|Participant Flow|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
10949946|NCT00807040|FG001|Participant Flow|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
10949947|NCT00807040|OG000|Outcome|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
10949948|NCT00807040|OG001|Outcome|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
10949949|NCT00807040|EG000|Reported Event|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
10949950|NCT00807040|EG001|Reported Event|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
10949951|NCT00807092|BG000|Baseline|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
10949952|NCT00807092|BG001|Baseline|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
10949953|NCT00807092|BG002|Baseline|Total|Total of all reporting groups
10949954|NCT00807092|FG000|Participant Flow|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
10949955|NCT00807092|FG001|Participant Flow|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
10949956|NCT00807092|OG000|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
11178141|NCT02046122|OG000|Outcome|Idarubicin + Cytarabine + DLI|"Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI)~Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.~Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy.~Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.~Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after"
11192226|NCT02137837|OG001|Outcome|Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)~Fulvestrant~Everolimus~Placebo - Anastrozole"
10949957|NCT00807092|OG001|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
10949958|NCT00807092|EG000|Reported Event|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
11178142|NCT02046122|EG000|Reported Event|Idarubicin + Cytarabine + DLI|"Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI)~Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.~Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy.~Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.~Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after"
11178143|NCT02046135|BG000|Baseline|Sodium Bicarbonate|"At the start of the surgery, the patient will receive NaHCO3 as a continuous infusion of D5% 1/3NS + 100 meq/L NaHCO3 + 20 meq/L KCl at maintenance IVF (solution contains ~154 meq of sodium which is equivalent to normal saline). The NaHCO3 infusion will continue for the first 24 hours after the discontinuation of CPB. After 24 hours of receiving the NaHCO3 infusion, the IVF administered to the patient will be the standard solutions used in the PICU at CCMC.~Sodium Bicarbonate"
11178144|NCT02046135|BG001|Baseline|Sodium Chloride|"At the start of surgery, patients in the control arm will receive D5% Normal Saline + 20 meq/L KCl at maintenance IVF. After 24 hours, standard IVF, not containing NaHCO3 or Na acetate will be administered for the duration of the PICU stay as required, determined by the clinicians primarily caring for the patient postoperatively.~Sodium Chloride"
11178145|NCT02046135|BG002|Baseline|Total|Total of all reporting groups
11178146|NCT02046135|FG000|Participant Flow|Sodium Bicarbonate|"At the start of the surgery, the patient will receive NaHCO3 as a continuous infusion of D5% 1/3NS + 100 meq/L NaHCO3 + 20 meq/L KCl at maintenance IVF (solution contains ~154 meq of sodium which is equivalent to normal saline). The NaHCO3 infusion will continue for the first 24 hours after the discontinuation of CPB. After 24 hours of receiving the NaHCO3 infusion, the IVF administered to the patient will be the standard solutions used in the PICU at CCMC.~Sodium Bicarbonate"
11178147|NCT02046135|FG001|Participant Flow|Sodium Chloride|"At the start of surgery, patients in the control arm will receive D5% Normal Saline + 20 meq/L KCl at maintenance IVF. After 24 hours, standard IVF, not containing NaHCO3 or Na acetate will be administered for the duration of the PICU stay as required, determined by the clinicians primarily caring for the patient postoperatively.~Sodium Chloride"
10949959|NCT00807092|EG001|Reported Event|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
10949960|NCT00807144|BG000|Baseline|Extended Release Tacrolimus|"Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy~Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml"
10949961|NCT00807144|BG001|Baseline|Standard Release Tacrolimus|"Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy~Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml"
10949962|NCT00807144|BG002|Baseline|Total|Total of all reporting groups
10949963|NCT00807144|FG000|Participant Flow|Extended Release Tacrolimus|"Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy~Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml"
10949964|NCT00807144|FG001|Participant Flow|Standard Release Tacrolimus|"Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy~Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml"
11178148|NCT02046135|OG000|Outcome|Sodium Bicarbonate|"At the start of the surgery, the patient will receive NaHCO3 as a continuous infusion of D5% 1/3NS + 100 meq/L NaHCO3 + 20 meq/L KCl at maintenance IVF (solution contains ~154 meq of sodium which is equivalent to normal saline). The NaHCO3 infusion will continue for the first 24 hours after the discontinuation of CPB. After 24 hours of receiving the NaHCO3 infusion, the IVF administered to the patient will be the standard solutions used in the PICU at CCMC.~Sodium Bicarbonate"
10949965|NCT00807144|OG000|Outcome|Extended Release Tacrolimus|"Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy~Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml"
10949966|NCT00807144|OG001|Outcome|Standard Release Tacrolimus|"Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy~Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml"
10949967|NCT00807144|EG000|Reported Event|Extended Release Tacrolimus|"Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy~Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml"
10949968|NCT00807144|EG001|Reported Event|Standard Release Tacrolimus|"Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy~Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml"
10949969|NCT00807209|BG000|Baseline|High Dose SKY0402|
10949970|NCT00807209|BG001|Baseline|Standard of Care|
10949971|NCT00807209|BG002|Baseline|Low Dose SKY0402|
10949972|NCT00807209|BG003|Baseline|Total|Total of all reporting groups
10949973|NCT00807209|FG000|Participant Flow|High Dose SKY0402|
10949974|NCT00807209|FG001|Participant Flow|Standard of Care|
10949975|NCT00807209|FG002|Participant Flow|Low Dose SKY0402|
10949976|NCT00807209|OG000|Outcome|High Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
10949977|NCT00807209|OG001|Outcome|Standard of Care|Bupivacaine HCl solution (1.25 mg/mL) and epinephrine (5 mcg/mL) administered via an epidural catheter at a concentration of 0.125% (1.25 mg/mL) at a rate of 8 cc per hour
10949978|NCT00807209|OG002|Outcome|Low Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
10949979|NCT00807209|EG000|Reported Event|High Dose SKY0402|
10949980|NCT00807209|EG001|Reported Event|Standard of Care|
10949981|NCT00807209|EG002|Reported Event|Low Dose SKY0402|
10949982|NCT00807235|BG000|Baseline|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
10949983|NCT00807235|BG001|Baseline|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
10949984|NCT00807235|BG002|Baseline|Total|Total of all reporting groups
10949985|NCT00807235|FG000|Participant Flow|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
10949986|NCT00807235|FG001|Participant Flow|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
10949987|NCT00807235|OG000|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
10949988|NCT00807235|OG001|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
10949989|NCT00807235|EG000|Reported Event|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
10949990|NCT00807235|EG001|Reported Event|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
10949991|NCT00807248|BG000|Baseline|Placebo (Orally, Once Daily)|
10949992|NCT00807248|BG001|Baseline|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
10949993|NCT00807248|BG002|Baseline|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
10949994|NCT00807248|BG003|Baseline|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
10949995|NCT00807248|BG004|Baseline|Total|Total of all reporting groups
10949996|NCT00807248|FG000|Participant Flow|Placebo (Orally, Once Daily)|
10949997|NCT00807248|FG001|Participant Flow|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
10949998|NCT00807248|FG002|Participant Flow|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
10949999|NCT00807248|FG003|Participant Flow|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
10950000|NCT00807248|OG000|Outcome|Placebo (Orally, Once Daily)|
10950001|NCT00807248|OG001|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
10950002|NCT00807248|OG002|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
10950003|NCT00807248|OG003|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
10950004|NCT00807248|EG000|Reported Event|Placebo (Orally, Once Daily)|
10950005|NCT00807248|EG001|Reported Event|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
10950006|NCT00807248|EG002|Reported Event|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
10950007|NCT00807248|EG003|Reported Event|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
10950008|NCT00807456|BG000|Baseline|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
10950009|NCT00807456|FG000|Participant Flow|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
10950010|NCT00807456|OG000|Outcome|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
10950011|NCT00807456|EG000|Reported Event|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
10950012|NCT00807495|BG000|Baseline|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950013|NCT00807495|BG001|Baseline|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950014|NCT00807495|BG002|Baseline|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950015|NCT00807495|BG003|Baseline|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950016|NCT00807495|BG004|Baseline|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950017|NCT00807495|BG005|Baseline|Total|Total of all reporting groups
10950018|NCT00807495|FG000|Participant Flow|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950019|NCT00807495|FG001|Participant Flow|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950020|NCT00807495|FG002|Participant Flow|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950021|NCT00807495|FG003|Participant Flow|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950022|NCT00807495|FG004|Participant Flow|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950023|NCT00807495|OG000|Outcome|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950024|NCT00807495|OG001|Outcome|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950025|NCT00807495|OG002|Outcome|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950026|NCT00807495|OG003|Outcome|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950027|NCT00807495|OG004|Outcome|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950028|NCT00807495|EG000|Reported Event|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950029|NCT00807495|EG001|Reported Event|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950030|NCT00807495|EG002|Reported Event|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10950031|NCT00807495|EG003|Reported Event|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
11178149|NCT02046135|OG001|Outcome|Sodium Chloride|"At the start of surgery, patients in the control arm will receive D5% Normal Saline + 20 meq/L KCl at maintenance IVF. After 24 hours, standard IVF, not containing NaHCO3 or Na acetate will be administered for the duration of the PICU stay as required, determined by the clinicians primarily caring for the patient postoperatively.~Sodium Chloride"
10950032|NCT00807495|EG004|Reported Event|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
10963652|NCT00873093|OG001|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
10963653|NCT00873093|OG002|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
10950033|NCT00807560|BG000|Baseline|FBT-PO|Family Based Therapy for Pediatric Overweight
10950034|NCT00807560|BG001|Baseline|NEC-control|Nutritional Educational Control Condition
10950035|NCT00807560|BG002|Baseline|Total|Total of all reporting groups
10950036|NCT00807560|FG000|Participant Flow|FBT-PO|"Family Based Therapy for Pediatric Overweight.~FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
10950037|NCT00807560|FG001|Participant Flow|NEC- Control|"Nutritional Educational Control Condition (NEC).~NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
11178150|NCT02046135|EG000|Reported Event|Sodium Bicarbonate|"At the start of the surgery, the patient will receive NaHCO3 as a continuous infusion of D5% 1/3NS + 100 meq/L NaHCO3 + 20 meq/L KCl at maintenance IVF (solution contains ~154 meq of sodium which is equivalent to normal saline). The NaHCO3 infusion will continue for the first 24 hours after the discontinuation of CPB. After 24 hours of receiving the NaHCO3 infusion, the IVF administered to the patient will be the standard solutions used in the PICU at CCMC.~Sodium Bicarbonate"
11178151|NCT02046135|EG001|Reported Event|Sodium Chloride|"At the start of surgery, patients in the control arm will receive D5% Normal Saline + 20 meq/L KCl at maintenance IVF. After 24 hours, standard IVF, not containing NaHCO3 or Na acetate will be administered for the duration of the PICU stay as required, determined by the clinicians primarily caring for the patient postoperatively.~Sodium Chloride"
10950038|NCT00807560|OG000|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
10950039|NCT00807560|OG001|Outcome|NEC-control|Nutritional Educational Control Condition
10950040|NCT00807560|EG000|Reported Event|FBT-PO|"Family Based Therapy for Pediatric Overweight.~FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
10950041|NCT00807560|EG001|Reported Event|NEC- Control|"Nutritional Educational Control Condition (NEC).~NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
10950042|NCT00807573|BG000|Baseline|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced NSCLC. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1, 15 and 19.
10950043|NCT00807573|FG000|Participant Flow|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
10950044|NCT00807573|OG000|Outcome|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
10950045|NCT00807573|EG000|Reported Event|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
11178152|NCT02046148|BG000|Baseline|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
10950046|NCT00807586|BG000|Baseline|Steroid|Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
10950047|NCT00807586|BG001|Baseline|Placebo|Placebo: Normal saline (1.6 cc)
10950048|NCT00807586|BG002|Baseline|Total|Total of all reporting groups
10950049|NCT00807586|FG000|Participant Flow|Steroid|Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
10950050|NCT00807586|FG001|Participant Flow|Placebo|Placebo: Normal saline (1.6 cc)
10950051|NCT00807586|OG000|Outcome|Steroid|Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
10950052|NCT00807586|OG001|Outcome|Placebo|Placebo: Normal saline (1.6 cc)
10950053|NCT00807586|EG000|Reported Event|Steroid|Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
10950054|NCT00807586|EG001|Reported Event|Placebo|Placebo: Normal saline (1.6 cc)
10950055|NCT00807599|BG000|Baseline|Continue Lenalidomide and Dexamethasone|"All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :~stem cell transplant right after collection~continue lenalidomide and dexamethasone~saving stem cell transplant for a later time.~lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L."
11178153|NCT02046148|BG001|Baseline|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
11178154|NCT02046148|BG002|Baseline|Total|Total of all reporting groups
10950056|NCT00807599|BG001|Baseline|Stem Cell Transplant x 1 or x 2|"All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :~stem cell transplant right after collection~continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.~Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.~On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L."
10950057|NCT00807599|BG002|Baseline|Total|Total of all reporting groups
10950058|NCT00807599|FG000|Participant Flow|Continue Lenalidomide and Dexamethasone|"All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :~stem cell transplant right after collection~continue lenalidomide and dexamethasone~saving stem cell transplant for a later time.~lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L."
10950059|NCT00807599|FG001|Participant Flow|Stem Cell Transplant x 1 or x 2|"All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :~stem cell transplant right after collection~continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.~Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.~On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L."
10950060|NCT00807599|FG002|Participant Flow|Not Evaluable|Participants were not randomized and are not evaluable
10950061|NCT00807599|OG000|Outcome|Continue Lenalidomide and Dexamethasone|"All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :~stem cell transplant right after collection~continue lenalidomide and dexamethasone~saving stem cell transplant for a later time.~lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L."
10950062|NCT00807599|OG001|Outcome|Stem Cell Transplant x 1 or x 2|"All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :~stem cell transplant right after collection~continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.~Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.~On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L."
10950063|NCT00807599|EG000|Reported Event|Continue Lenalidomide and Dexamethasone|"All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :~stem cell transplant right after collection~continue lenalidomide and dexamethasone~saving stem cell transplant for a later time.~lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L."
10950064|NCT00807599|EG001|Reported Event|Stem Cell Transplant x 1 or x 2|"All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :~stem cell transplant right after collection~continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.~Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.~On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L."
10950065|NCT00807664|BG000|Baseline|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
10950066|NCT00807664|BG001|Baseline|Biatain Wound Dressing|Biatain dressing is a foam wound dressing
10950067|NCT00807664|BG002|Baseline|Total|Total of all reporting groups
10950068|NCT00807664|FG000|Participant Flow|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
10950069|NCT00807664|FG001|Participant Flow|Biatain Wound Dressing|Biatain dressing is a foam wound dressing
10950070|NCT00807664|OG000|Outcome|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
10950071|NCT00807664|OG001|Outcome|Biatain Wound Dressing|Biatain dressing is a foam wound dressing
10950072|NCT00807664|OG001|Outcome|Biatain Dressing|Biatain dressing is a foam wound dressing
10950073|NCT00807664|EG000|Reported Event|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
10950074|NCT00807664|EG001|Reported Event|Biatain Wound Dressing|Biatain dressing is a foam wound dressing
10950075|NCT00807742|BG000|Baseline|Contingency Management (CM)|"Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.~Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.~Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all."
10950076|NCT00807742|BG001|Baseline|Noncontingent Reinforcement (NR)|"Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.~Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.~Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all."
10950077|NCT00807742|BG002|Baseline|Total|Total of all reporting groups
10950078|NCT00807742|FG000|Participant Flow|Contingency Management (CM)|"Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.~Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.~Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all."
10950079|NCT00807742|FG001|Participant Flow|Noncontingent Reinforcement (NR)|"Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.~Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.~Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all."
10950080|NCT00807742|OG000|Outcome|Contingency Management (CM)|"Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.~Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.~Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all."
10950081|NCT00807742|OG001|Outcome|Noncontingent Reinforcement (NR)|"Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.~Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.~Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all."
10950082|NCT00807742|EG000|Reported Event|Contingency Management (CM)|"Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.~Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.~Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all."
10950083|NCT00807742|EG001|Reported Event|Noncontingent Reinforcement (NR)|"Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.~Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.~Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all."
10950084|NCT00807768|BG000|Baseline|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10950085|NCT00807768|BG001|Baseline|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10950086|NCT00807768|BG002|Baseline|Total|Total of all reporting groups
10950087|NCT00807768|FG000|Participant Flow|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11178155|NCT02046148|FG000|Participant Flow|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
11178156|NCT02046148|FG001|Participant Flow|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
11178157|NCT02046148|OG000|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
11178158|NCT02046148|OG001|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
11178159|NCT02046148|EG000|Reported Event|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
11178160|NCT02046148|EG001|Reported Event|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
11178161|NCT02046174|BG000|Baseline|Macrobead Implantation Arm|mCRC patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.
11178162|NCT02046174|FG000|Participant Flow|Macrobead Implantation Arm|"mCRC patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.~RENCA macrobeads"
11178163|NCT02046174|FG001|Participant Flow|Best Supportive Care Arm|mCRC patients who had previously decided (independently of this study) to receive, or continue receiving, best supportive care, defined as management of symptoms aimed at maintaining or improving quality of life, but not including approved therapies targeting the patient's malignancy.
11178164|NCT02046174|OG000|Outcome|Macrobead Implantation Arm|mCRC patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.
11178165|NCT02046174|OG000|Outcome|Implant 1: Day 0|ECOG score at day 0 of first implantation
11178166|NCT02046174|OG001|Outcome|Implant 1: Day 14|ECOG score at day 14 after first implantation
11178167|NCT02046174|OG002|Outcome|Implant 1: Day 30|ECOG score at day 30 following first implantation
10950088|NCT00807768|FG001|Participant Flow|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10950089|NCT00807768|OG000|Outcome|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10950090|NCT00807768|OG001|Outcome|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10950091|NCT00807768|EG000|Reported Event|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10950092|NCT00807768|EG001|Reported Event|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10950093|NCT00807846|BG000|Baseline|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
10950094|NCT00807846|BG001|Baseline|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
10950095|NCT00807846|BG002|Baseline|Total|Total of all reporting groups
10950096|NCT00807846|FG000|Participant Flow|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
10950097|NCT00807846|FG001|Participant Flow|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
10950098|NCT00807846|OG000|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
10950099|NCT00807846|OG001|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
10950100|NCT00807846|EG000|Reported Event|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
10950101|NCT00807846|EG001|Reported Event|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
10950102|NCT00807885|BG000|Baseline|Tegaderm-secured 24 ga Teflon Catheter|
10950103|NCT00807885|BG001|Baseline|Tape-secured 24 ga Teflon Catheter|
10950104|NCT00807885|BG002|Baseline|Tegaderm-secured 24 ga Polyurethane Catheter|
10950105|NCT00807885|BG003|Baseline|Tape-secured 24 ga Polyurethane Catheter|
10950106|NCT00807885|BG004|Baseline|Tegaderm-secured 20 ga Teflon Catheter|
10950107|NCT00807885|BG005|Baseline|Tape-secured 20 ga Teflon Catheter|
10950108|NCT00807885|BG006|Baseline|Tegaderm-secured 20 ga Polyurethane Catheter|
10950109|NCT00807885|BG007|Baseline|Tape-secured 20 ga Polyurethane Catheter|
10950110|NCT00807885|BG008|Baseline|SC Button With 27 ga X 9 mm Needle|
11178168|NCT02046174|OG003|Outcome|Implant 1: Day 60|ECOG score at day 60 following first implantation
10950111|NCT00807885|BG009|Baseline|Total|Total of all reporting groups
10950112|NCT00807885|FG000|Participant Flow|Tegaderm-secured 24 ga Teflon Catheter|
10950113|NCT00807885|FG001|Participant Flow|Tape-secured 24 ga Teflon Catheter|
10950114|NCT00807885|FG002|Participant Flow|Tegaderm-secured 24 ga Polyurethane Catheter|
10950115|NCT00807885|FG003|Participant Flow|Tape-secured 24 ga Polyurethane Catheter|
10950116|NCT00807885|FG004|Participant Flow|Tegaderm-secured 20 ga Teflon Catheter|
10950117|NCT00807885|FG005|Participant Flow|Tape-secured 20 ga Teflon Catheter|
10950118|NCT00807885|FG006|Participant Flow|Tegaderm-secured 20 ga Polyurethane Catheter|
10950119|NCT00807885|FG007|Participant Flow|Tape-secured 20 ga Polyurethane Catheter|
10950120|NCT00807885|FG008|Participant Flow|SC Button With 27 ga X 9 mm Needle|
10950121|NCT00807885|OG000|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
10950122|NCT00807885|OG001|Outcome|Tape-secured 24 ga Teflon Catheter|
10950123|NCT00807885|OG002|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
10950124|NCT00807885|OG003|Outcome|Tape-secured 24 ga Polyurethane Catheter|
10950125|NCT00807885|OG004|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
10950126|NCT00807885|OG005|Outcome|Tape-secured 20 ga Teflon Catheter|
10950127|NCT00807885|OG006|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
10950128|NCT00807885|OG007|Outcome|Tape-secured 20 ga Polyurethane Catheter|
11178169|NCT02046174|OG004|Outcome|Implant 2: Day 0|ECOG score at day 0 of second implantation
11178170|NCT02046174|OG005|Outcome|Implant 2: Day 14|ECOG score at day 14 following second implantation
10950129|NCT00807885|OG008|Outcome|SC Button With 27 ga X 9 mm Needle|
10950130|NCT00807885|EG000|Reported Event|Tegaderm-secured 24 ga Teflon Catheter|
10950131|NCT00807885|EG001|Reported Event|Tape-secured 24 ga Teflon Catheter|
10950132|NCT00807885|EG002|Reported Event|Tegaderm-secured 24 ga Polyurethane Catheter|
10950133|NCT00807885|EG003|Reported Event|Tape-secured 24 ga Polyurethane Catheter|
10950134|NCT00807885|EG004|Reported Event|Tegaderm-secured 20 ga Teflon Catheter|
10950135|NCT00807885|EG005|Reported Event|Tape-secured 20 ga Teflon Catheter|
11178171|NCT02046174|OG006|Outcome|Implant 2: Day 30|ECOG score at day 30 following second implantation
10950136|NCT00807885|EG006|Reported Event|Tegaderm-secured 20 ga Polyurethane Catheter|
10950137|NCT00807885|EG007|Reported Event|Tape-secured 20 ga Polyurethane Catheter|
10950138|NCT00807885|EG008|Reported Event|SC Button With 27 ga X 9 mm Needle|
10950139|NCT00807937|BG000|Baseline|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
10950140|NCT00807937|BG001|Baseline|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
10950141|NCT00807937|BG002|Baseline|Lorazepam|Lorazepam 2 mg twice daily (BID)
10950142|NCT00807937|BG003|Baseline|Placebo|Placebo
10950143|NCT00807937|BG004|Baseline|Total|Total of all reporting groups
10950144|NCT00807937|FG000|Participant Flow|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
10950145|NCT00807937|FG001|Participant Flow|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
10950146|NCT00807937|FG002|Participant Flow|Lorazepam|Lorazepam 2 mg twice daily (BID)
10950147|NCT00807937|FG003|Participant Flow|Placebo|Placebo
10950148|NCT00807937|OG000|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
10950149|NCT00807937|OG001|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
10950150|NCT00807937|OG002|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
10950151|NCT00807937|OG003|Outcome|Placebo|Placebo
10950152|NCT00807937|EG000|Reported Event|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
10950153|NCT00807937|EG001|Reported Event|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
10950154|NCT00807937|EG002|Reported Event|Lorazepam|Lorazepam 2 mg twice daily (BID)
10950155|NCT00807937|EG003|Reported Event|Placebo|Placebo
10950156|NCT00807989|BG000|Baseline|Carbamazepine|"Carbamazepine~Carbamazepine"
10950157|NCT00807989|BG001|Baseline|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
10950158|NCT00807989|BG002|Baseline|Total|Total of all reporting groups
10950159|NCT00807989|FG000|Participant Flow|Carbamazepine|Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses
10950160|NCT00807989|FG001|Participant Flow|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day"
10950161|NCT00807989|OG000|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
10950162|NCT00807989|OG001|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
10950163|NCT00807989|EG000|Reported Event|Carbamazepine|"Carbamazepine~Carbamazepine"
10950164|NCT00807989|EG001|Reported Event|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
10950165|NCT00808015|BG000|Baseline|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
10950166|NCT00808015|FG000|Participant Flow|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
10950167|NCT00808015|OG000|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
10950168|NCT00808015|EG000|Reported Event|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
10950169|NCT00808028|BG000|Baseline|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950170|NCT00808028|BG001|Baseline|rLP2086 60 mcg|Given on a 0, 2-, 6-month schedule in Stage 1.
10950171|NCT00808028|BG002|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950172|NCT00808028|BG003|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950173|NCT00808028|BG004|Baseline|Total|Total of all reporting groups
10950174|NCT00808028|FG000|Participant Flow|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950175|NCT00808028|FG001|Participant Flow|rLP2086 60 Microgram (mcg)|Given on a 0, 2-, 6-month schedule in Stage 1
11178172|NCT02046174|OG007|Outcome|Implant 2: Day 60|ECOG score at day 60 following second implantation
11178173|NCT02046174|OG000|Outcome|Implant 1: Day 0|KPS score at pre-screening for first implantation
10950176|NCT00808028|FG002|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950177|NCT00808028|FG003|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950178|NCT00808028|OG000|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950179|NCT00808028|OG001|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
10950180|NCT00808028|OG002|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950181|NCT00808028|OG003|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
10950182|NCT00808028|OG000|Outcome|Control- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
10950183|NCT00808028|OG001|Outcome|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
10950184|NCT00808028|OG002|Outcome|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
10950185|NCT00808028|EG000|Reported Event|Control- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
10950186|NCT00808028|EG001|Reported Event|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
10950187|NCT00808028|EG002|Reported Event|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
10950188|NCT00808028|EG003|Reported Event|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
10950189|NCT00808028|EG004|Reported Event|Control-Stage 1 Follow-up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
10950190|NCT00808028|EG005|Reported Event|rLP2086 60 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
10950191|NCT00808028|EG006|Reported Event|rLP2086 120 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
10950192|NCT00808028|EG007|Reported Event|rLP2086 200 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
10950193|NCT00808028|EG008|Reported Event|Control-Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
10950194|NCT00808028|EG009|Reported Event|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
10950195|NCT00808028|EG010|Reported Event|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
10950196|NCT00808067|BG000|Baseline|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
10950197|NCT00808067|BG001|Baseline|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
10950198|NCT00808067|BG002|Baseline|Total|Total of all reporting groups
10950199|NCT00808067|FG000|Participant Flow|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
10950200|NCT00808067|FG001|Participant Flow|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
10950201|NCT00808067|OG000|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
10950202|NCT00808067|OG001|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
10950203|NCT00808067|EG000|Reported Event|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
10950204|NCT00808067|EG001|Reported Event|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
10950205|NCT00808132|BG000|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950206|NCT00808132|BG001|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950207|NCT00808132|BG002|Baseline|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950208|NCT00808132|BG003|Baseline|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950209|NCT00808132|BG004|Baseline|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950210|NCT00808132|BG005|Baseline|Total|Total of all reporting groups
10950211|NCT00808132|FG000|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950212|NCT00808132|FG001|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950213|NCT00808132|FG002|Participant Flow|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950214|NCT00808132|FG003|Participant Flow|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950215|NCT00808132|FG004|Participant Flow|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950216|NCT00808132|OG000|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950217|NCT00808132|OG001|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
11178174|NCT02046174|OG001|Outcome|Implant 1: Day 14|KPS score at day 14 after first implantation
10950218|NCT00808132|OG002|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950219|NCT00808132|OG003|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950220|NCT00808132|OG004|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950221|NCT00808132|EG000|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950222|NCT00808132|EG001|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950223|NCT00808132|EG002|Reported Event|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950224|NCT00808132|EG003|Reported Event|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950225|NCT00808132|EG004|Reported Event|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
10950226|NCT00808210|BG000|Baseline|Ocrelizumab 200mg|Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
10950227|NCT00808210|BG001|Baseline|Infliximab 5mg/kg|Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
10950228|NCT00808210|BG002|Baseline|Total|Total of all reporting groups
10950229|NCT00808210|FG000|Participant Flow|Ocrelizumab 200mg|Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
10950230|NCT00808210|FG001|Participant Flow|Infliximab 5mg/kg|Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
10950231|NCT00808210|OG000|Outcome|Ocrelizumab 200mg|Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
10950232|NCT00808210|OG001|Outcome|Infliximab 5mg/kg|Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
10950233|NCT00808210|EG000|Reported Event|Ocrelizumab 200mg|Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
10950234|NCT00808210|EG001|Reported Event|Infliximab 5mg/kg|Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
10950235|NCT00808236|BG000|Baseline|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
10950236|NCT00808236|BG001|Baseline|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
10950237|NCT00808236|BG002|Baseline|Total|Total of all reporting groups
10950238|NCT00808236|FG000|Participant Flow|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
11178175|NCT02046174|OG002|Outcome|Implant 1: Day 30|KPS score at day 30 following first implantation
11178176|NCT02046174|OG003|Outcome|Implant 1: Day 60|KPS score at day 60 following first implantation
10950239|NCT00808236|FG001|Participant Flow|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
10950240|NCT00808236|OG000|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
10950241|NCT00808236|OG001|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
10950242|NCT00808236|EG000|Reported Event|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
10950243|NCT00808236|EG001|Reported Event|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
10950244|NCT00808249|BG000|Baseline|A-AZD7325 2 mg|AZD7325 2 mg BID
10950245|NCT00808249|BG001|Baseline|B-AZD7325 5 mg|AZD7325 5 mg BID
10950246|NCT00808249|BG002|Baseline|C-AZD7325 10 mg|AZD7325 10 mg QD
10950247|NCT00808249|BG003|Baseline|D-Placebo|Placebo
10950248|NCT00808249|BG004|Baseline|Total|Total of all reporting groups
10950249|NCT00808249|FG000|Participant Flow|A-AZD7325 2 mg|AZD7325 2 mg BID
10950250|NCT00808249|FG001|Participant Flow|B-AZD7325 5 mg|AZD7325 5 mg BID
10950251|NCT00808249|FG002|Participant Flow|C-AZD7325 10 mg|AZD7325 10 mg QD
11178177|NCT02046174|OG004|Outcome|Implant 2: Day 0|KPS score at pre-screening for second implantation (day 90 following first implantation).
10950252|NCT00808249|FG003|Participant Flow|D-Placebo|Placebo
10950253|NCT00808249|OG000|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
10950254|NCT00808249|OG001|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
10950255|NCT00808249|OG002|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
10950256|NCT00808249|OG003|Outcome|D-Placebo|Placebo
10950257|NCT00808249|EG000|Reported Event|A-AZD7325 2 mg|AZD7325 2 mg BID
10950258|NCT00808249|EG001|Reported Event|B-AZD7325 5 mg|AZD7325 5 mg BID
10950259|NCT00808249|EG002|Reported Event|C-AZD7325 10 mg|AZD7325 10 mg QD
10950260|NCT00808249|EG003|Reported Event|D-Placebo|Placebo
10950261|NCT00808340|BG000|Baseline|Overall|
11178178|NCT02046174|OG005|Outcome|Implant 2: Day 14|KPS score at day 14 following second implantation
11178179|NCT02046174|OG006|Outcome|Implant 2: Day 30|KPS score at day 30 following second implantation
11178180|NCT02046174|OG007|Outcome|Implant 2: Day 60|KPS score at day 60 following second implantation
11178181|NCT02046174|OG000|Outcome|Implant 1: Day 0|Global health score at pre-screening for first implantation
11178182|NCT02046174|OG001|Outcome|Implant 1: Day 14|Global health score at day 14 after first implantation
10950262|NCT00808340|FG000|Participant Flow|Senofilcon A Test/Senofilcon A Prod/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
10950263|NCT00808340|FG001|Participant Flow|Senofilcon A Test/Balafilcon A/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
10950264|NCT00808340|FG002|Participant Flow|Senofilcon A Prod/Senofilcon A Test/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, senofilcon A test worn second, and balafilcon A worn third.
10950265|NCT00808340|FG003|Participant Flow|Senofilcon A Prod/ Balifilcon A/ Senofilcon A Test|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, balafilcon A worn second, and senofilcon A test worn third.
10950266|NCT00808340|FG004|Participant Flow|Balafilcon A/Senofilcon A Test/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
10950267|NCT00808340|FG005|Participant Flow|Balafilcon A/Senofilcon A Prod/Senofilcon A Test|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A producton worn second, senofilcon A test worn third.
10950268|NCT00808340|OG000|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
10950269|NCT00808340|OG001|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
10950270|NCT00808340|OG002|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
10950271|NCT00808340|EG000|Reported Event|Senofilcon A Test|
10950272|NCT00808340|EG001|Reported Event|Senofilcon A Prod|
10950273|NCT00808340|EG002|Reported Event|Balafilcon A|
10950274|NCT00808405|BG000|Baseline|Acyclovir|Acyclovir 400 mg orally three times daily
10950275|NCT00808405|BG001|Baseline|Placebo|Matching placebo tablet
10950276|NCT00808405|BG002|Baseline|Total|Total of all reporting groups
10950277|NCT00808405|FG000|Participant Flow|Acyclovir|Acyclovir 400 mg orally three times daily
10950278|NCT00808405|FG001|Participant Flow|Placebo|Matching placebo tablet
10950279|NCT00808405|OG000|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
10950280|NCT00808405|OG001|Outcome|Placebo|Matching placebo tablet
10950281|NCT00808405|EG000|Reported Event|Acyclovir|Acyclovir 400 mg orally three times daily
10950282|NCT00808405|EG001|Reported Event|Placebo|Matching placebo tablet
10950283|NCT00808444|BG000|Baseline|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
10950284|NCT00808444|BG001|Baseline|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
10950285|NCT00808444|BG002|Baseline|Total|Total of all reporting groups
10950286|NCT00808444|FG000|Participant Flow|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
11178183|NCT02046174|OG002|Outcome|Implant 1: Day 30|Global health score at day 30 following first implantation
11178184|NCT02046174|OG003|Outcome|Implant 1: Day 60|Global health score at day 60 following first implantation
11178185|NCT02046174|OG004|Outcome|Implant 2: Day 0|Global health score at pre-screening for second implantation (day 90 following first implantation)
11178186|NCT02046174|OG005|Outcome|Implant 2: Day 14|Global health score at day 14 following second implantation
10950287|NCT00808444|FG001|Participant Flow|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
10950288|NCT00808444|OG000|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
10950289|NCT00808444|OG001|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
10950290|NCT00808444|EG000|Reported Event|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
10950291|NCT00808444|EG001|Reported Event|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
10950292|NCT00808470|BG000|Baseline|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
10950293|NCT00808470|BG001|Baseline|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
10950294|NCT00808470|BG002|Baseline|Total|Total of all reporting groups
10950295|NCT00808470|FG000|Participant Flow|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
10950296|NCT00808470|FG001|Participant Flow|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
10950297|NCT00808470|OG000|Outcome|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
10950298|NCT00808470|OG001|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
10950299|NCT00808470|OG000|Outcome|Nutrients|"Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
10950300|NCT00808470|OG001|Outcome|Placebo for Nutrients|"Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
11178187|NCT02046174|OG006|Outcome|Implant 2: Day 30|Global health score at day 30 following second implantation
11178188|NCT02046174|OG007|Outcome|Implant 2: Day 60|Global health score at day 60 following second implantation
11178189|NCT02046174|OG000|Outcome|Implant 1: Day 0|EORTC/Physical functioning score at pre-screening for first implantation
11178190|NCT02046174|OG001|Outcome|Implant 1: Day 14|EORTC/Physical functioning score at day 14 following first implantation
11178191|NCT02046174|OG002|Outcome|Implant 1: Day 30|EORTC/Physical functioning score at day 30 following first implantation
10950301|NCT00808470|OG000|Outcome|Nutrients|"beta-carotene, vitamins C and E, magnesium~beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
10950302|NCT00808470|OG001|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
10950303|NCT00808470|EG000|Reported Event|Nutrients|"Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
10950304|NCT00808470|EG001|Reported Event|Placebo for Nutrients|"Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
10950305|NCT00808483|BG000|Baseline|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and sit-to-stand with guidance and supervision from a physiotherapist."
10950306|NCT00808483|BG001|Baseline|Control Group|No participation in the walking skill training group
10950307|NCT00808483|BG002|Baseline|Total|Total of all reporting groups
11178192|NCT02046174|OG003|Outcome|Implant 1: Day 60|EORTC/Physical functioning score at day 60 following first implantation
11178193|NCT02046174|OG004|Outcome|Implant 2: Day 0|EORTC/Physical functioning score at pre-screening for second implantation (day 90 following first implantation).
11178194|NCT02046174|OG005|Outcome|Implant 2: Day 14|EORTC/Physical functioning score at day 14 following second implantation
11178195|NCT02046174|OG006|Outcome|Implant 2: Day 30|EORTC/Physical functioning score at day 30 following second implantation
11178196|NCT02046174|OG007|Outcome|Implant 2: Day 60|EORTC/Physical functioning score at day 60 following second implantation
10950308|NCT00808483|FG000|Participant Flow|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
10950309|NCT00808483|FG001|Participant Flow|Control Group|No participation in the walking skill training group
10950310|NCT00808483|OG000|Outcome|Walking Skill Training Group|"12 sessions of participation in the supervised walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
10950311|NCT00808483|OG001|Outcome|Control Group|No participation in the walking skill training program
10950312|NCT00808483|OG000|Outcome|Walking Skill Training Group|12 session of participation in the supervised walking skill training program
10950313|NCT00808483|OG000|Outcome|Walking Skill Training Group|12 sessions of participation in a supervised walking skill training program
10950314|NCT00808483|OG000|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training group
10950315|NCT00808483|OG000|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
10950316|NCT00808483|OG001|Outcome|Control Group|No sessions of participation in the walking skill training program
10950317|NCT00808483|OG000|Outcome|Walking Skilll Training Group|12 sessions of participation in the supervised walking skilll training program
10950318|NCT00808483|OG001|Outcome|Control Group|No session of participation in the walking skill training program
10950319|NCT00808483|EG000|Reported Event|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
10950320|NCT00808483|EG001|Reported Event|Control Group|No participation in the walking skill training group
10950321|NCT00808509|BG000|Baseline|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950322|NCT00808509|BG001|Baseline|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950323|NCT00808509|BG002|Baseline|Total|Total of all reporting groups
10950324|NCT00808509|FG000|Participant Flow|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
11178197|NCT02046174|OG000|Outcome|Implant 1: Day 0|EORTC/Role functioning score at pre-screening for first implantation
11178198|NCT02046174|OG001|Outcome|Implant 1: Day 14|EORTC/Role functioning score at day 14 following first implantation
11178199|NCT02046174|OG002|Outcome|Implant 1: Day 30|EORTC/Role functioning score at day 30 following first implantation
11178200|NCT02046174|OG003|Outcome|Implant 1: Day 60|EORTC/Role functioning score at day 60 following first implantation
10950325|NCT00808509|FG001|Participant Flow|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950326|NCT00808509|OG000|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950327|NCT00808509|OG001|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950328|NCT00808509|EG000|Reported Event|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950329|NCT00808509|EG001|Reported Event|Methotrexate-Excluding Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks and were not reinstituted to adalimumab as rescue treatment. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950330|NCT00808509|EG002|Reported Event|Methotrexate-Rescue Arm|Participants received methotrexate alone for 52 weeks, but due to an increase in disease activity were reinstituted with adalimumab 40 mg subcutaneously every other week during the 52-week randomized period. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950331|NCT00808509|EG003|Reported Event|Methotrexate-Including Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
10950332|NCT00808639|BG000|Baseline|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
10950333|NCT00808639|FG000|Participant Flow|Dose Dense MVAC|Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)
10950334|NCT00808639|OG000|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
11178201|NCT02046174|OG004|Outcome|Implant 2: Day 0|EORTC/Role functioning score at pre-screening for second implantation (day 90 following first implantation).
10950335|NCT00808639|EG000|Reported Event|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
10950336|NCT00808665|BG000|Baseline|Dexmedetomidine|"At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
10950337|NCT00808665|BG001|Baseline|Saline|"Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
10950338|NCT00808665|BG002|Baseline|Total|Total of all reporting groups
10950339|NCT00808665|FG000|Participant Flow|Dexmedetomidine|"At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
11178202|NCT02046174|OG005|Outcome|Implant 2: Day 14|EORTC/Role functioning score at day 14 following second implantation
11178203|NCT02046174|OG006|Outcome|Implant 2: Day 30|EORTC/Role functioning score at day 30 following second implantation
11178204|NCT02046174|OG007|Outcome|Implant 2: Day 60|EORTC/Role functioning score at day 60 following second implantation
11178205|NCT02046174|OG000|Outcome|Implant 1: Day 0|EORTC/Emotional functioning score at pre-screening for first implantation
10950340|NCT00808665|FG001|Participant Flow|Saline|"Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
10950341|NCT00808665|OG000|Outcome|Dexmedetomidine|"At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
10950342|NCT00808665|OG001|Outcome|Saline|"Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
10950343|NCT00808665|EG000|Reported Event|Dexmedetomidine|"At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
10950344|NCT00808665|EG001|Reported Event|Saline|"Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
10950345|NCT00808808|BG000|Baseline|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
10950346|NCT00808808|BG001|Baseline|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
11178206|NCT02046174|OG001|Outcome|Implant 1: Day 14|EORTC/Emotional functioning score at day 14 following first implantation
11178207|NCT02046174|OG002|Outcome|Implant 1: Day 30|EORTC/Emotional functioning score at day 30 following first implantation
11178208|NCT02046174|OG003|Outcome|Implant 1: Day 60|EORTC/Emotional functioning score at day 60 following first implantation
11178209|NCT02046174|OG004|Outcome|Implant 2: Day 0|EORTC/Emotional functioning score at pre-screening for second implantation (day 90 following first implantation).
11178210|NCT02046174|OG005|Outcome|Implant 2: Day 14|EORTC/Emotional functioning score at day 14 following second implantation
11178211|NCT02046174|OG006|Outcome|Implant 2: Day 30|EORTC/Emotional functioning score at day 30 following second implantation
11178212|NCT02046174|OG007|Outcome|Implant 2: Day 60|EORTC/Emotional functioning score at day 60 following second implantation
11178213|NCT02046174|OG000|Outcome|Implant 1: Day 0|EORTC/Cognitive functioning score at pre-screening for first implantation
11178214|NCT02046174|OG001|Outcome|Implant 1: Day 14|EORTC/Cognitive functioning score at day 14 following first implantation
11178215|NCT02046174|OG002|Outcome|Implant 1: Day 30|EORTC/Cognitive functioning score at day 30 following first implantation
11178216|NCT02046174|OG003|Outcome|Implant 1: Day 60|EORTC/Cognitive functioning score at day 60 following first implantation
11178217|NCT02046174|OG004|Outcome|Implant 2: Day 0|EORTC/Cognitive functioning score at pre-screening for second implantation (day 90 following first implantation).
11178218|NCT02046174|OG005|Outcome|Implant 2: Day 14|EORTC/Cognitive functioning score at day 14 following second implantation
11178219|NCT02046174|OG006|Outcome|Implant 2: Day 30|EORTC/Cognitive functioning score at day 30 following second implantation
11178220|NCT02046174|OG007|Outcome|Implant 2: Day 60|EORTC/Cognitive functioning score at day 60 following second implantation
11178221|NCT02046174|OG000|Outcome|Implant 1: Day 0|EORTC/Social functioning score at pre-screening for first implantation
11178222|NCT02046174|OG001|Outcome|Implant 1: Day 14|EORTC/Social functioning score at day 14 following first implantation
11178223|NCT02046174|OG002|Outcome|Implant 1: Day 30|EORTC/Social functioning score at day 30 following first implantation
11178224|NCT02046174|OG003|Outcome|Implant 1: Day 60|EORTC/Social functioning score at day 60 following first implantation
11178225|NCT02046174|OG004|Outcome|Implant 2: Day 0|EORTC/Social functioning score at pre-screening for second implantation (day 90 following first implantation).
11178226|NCT02046174|OG005|Outcome|Implant 2: Day 14|EORTC/Social functioning score at day 14 following second implantation
10950347|NCT00808808|BG002|Baseline|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
10950348|NCT00808808|BG003|Baseline|Total|Total of all reporting groups
10950349|NCT00808808|FG000|Participant Flow|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
10950350|NCT00808808|FG001|Participant Flow|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
10950351|NCT00808808|FG002|Participant Flow|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
10950352|NCT00808808|OG000|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
10950353|NCT00808808|OG001|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
11178227|NCT02046174|OG006|Outcome|Implant 2: Day 30|EORTC/Social functioning score at day 30 following second implantation
11178228|NCT02046174|OG007|Outcome|Implant 2: Day 60|EORTC/Social functioning score at day 60 following second implantation
11178229|NCT02046174|OG000|Outcome|Implant 1: Day 0|Pain Assessment score at pre-screening for first implantation
11178230|NCT02046174|OG001|Outcome|Implant 1: Day 14|Pain Assessment score at day 14 following first implantation
11178231|NCT02046174|OG002|Outcome|Implant 1: Day 30|Pain Assessment score at day 30 following first implantation
11178232|NCT02046174|OG003|Outcome|Implant 1: Day 60|Pain Assessment score at day 60 following first implantation
10950354|NCT00808808|OG002|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
10950355|NCT00808808|OG000|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as white
10950356|NCT00808808|OG001|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as white.
10950357|NCT00808808|OG000|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as college graduates.
10950358|NCT00808808|OG001|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as college graduates.
10950359|NCT00808808|OG000|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as male.
10950360|NCT00808808|OG001|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as male.
10950361|NCT00808808|EG000|Reported Event|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
10950362|NCT00808808|EG001|Reported Event|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
10950363|NCT00808808|EG002|Reported Event|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
10950364|NCT00808834|BG000|Baseline|Overall|This reporting group includes all enrolled and exposed subjects.
10950365|NCT00808834|FG000|Participant Flow|Senofilcon A / Lotrafilcon A|Senofilcon A, followed by Lotrafilcon A
10950366|NCT00808834|FG001|Participant Flow|Lotrafilcon A / Senofilcon A|Lotrafilcon A, followed by Senofilcon A
10950367|NCT00808834|OG000|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
10950368|NCT00808834|OG001|Outcome|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
10950369|NCT00808834|EG000|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
11178233|NCT02046174|OG004|Outcome|Implant 2: Day 0|Pain Assessment score at pre-screening for second implantation (day 90 following first implantation).
11178234|NCT02046174|OG005|Outcome|Implant 2: Day 14|Pain Assessment score at day 14 following second implantation
11178235|NCT02046174|OG006|Outcome|Implant 2: Day 30|Pain Assessment score at day 30 following second implantation
11178236|NCT02046174|OG007|Outcome|Implant 2: Day 60|Pain Assessment score at day 60 following second implantation
11178237|NCT02046174|OG000|Outcome|CEA Only|Participants whose tumor marker response was greater than or equal to 20% decrease from baseline in CEA only [up to and including day 90 after the first implant).
11178238|NCT02046174|OG001|Outcome|CA 19-9 Only|Participants whose tumor marker response was greater than or equal to 20% decrease from baseline in CA 19-9 only [up to and including day 90 after the first implant).
11178239|NCT02046174|OG002|Outcome|Both CEA and CA 19-9|Participants whose tumor marker response was greater than or equal to 20% decrease from baseline in both CEA and CA 19-9 [up to and including day 90 after the first implant).
11178240|NCT02046174|OG003|Outcome|Non-responder|Participants whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.
11178241|NCT02046174|OG000|Outcome|Responder|Responders is defined as any participant having a 20% or more decrease from baseline levels of the biomarker carcinoembryonic antigen (CEA) or cancer antigen 19-9 (CA 19-9), or both, following RENCA macrobead implantation.
11178242|NCT02046174|OG001|Outcome|Non-Responder|Non-Responder is defined as any participant not having a 20% or more decrease from baseline levels of the biomarker carcinoembryonic antigen (CEA) or cancer antigen 19-9 (CA 19-9), or both, following RENCA macrobead implantation.
11178243|NCT02046174|OG000|Outcome|Stable Disease|Stable disease based on imaging results [Tumor measurement/SUV max].
11178244|NCT02046174|OG001|Outcome|Decreased/Necrosis|Decreased/Necrosis observed based on imaging results [tumor measurement/SUV max].
11178245|NCT02046174|OG002|Outcome|Increased|Increased SUVmax, tumor measurement based on imaging results.
11178246|NCT02046174|EG000|Reported Event|Macrobead Implantation Arm|"Analysis population was limited to the arm macrobead implantation as the proposed second arm best supportive care did not enroll enough participants to facilitate reliable analysis. The arm reported here includes all patients who had at least one implantation of RENCA macrobeads."
11178247|NCT02046200|BG000|Baseline|IVM 30mg; Placebo|"Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.~Placebo: Single dose sugar pill matched to active medication."
10950370|NCT00808834|EG001|Reported Event|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
11178248|NCT02046200|FG000|Participant Flow|IVM 30mg First, Then Placebo|"First Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.~Second Intervention, Placebo: Single dose sugar pill, matched to active medication."
11178249|NCT02046200|FG001|Participant Flow|Placebo First, Then IVM 30 mg|"First Intervention, Placebo: Single dose sugar pill, matched to active medication.~Second Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin."
11178250|NCT02046200|OG000|Outcome|Placebo|Single dose sugar pill, matched to active medication.
11178251|NCT02046200|OG001|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
11178252|NCT02046200|OG001|Outcome|IVM 30mg|Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
11178253|NCT02046200|OG000|Outcome|Placebo (BrAC = 0.00)|Single dose sugar pill, matched to active medication. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
11178254|NCT02046200|OG001|Outcome|Placebo (BrAC = 0.04)|Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.04.
11178255|NCT02046200|OG002|Outcome|Placebo (BrAC = 0.08)|Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
11178256|NCT02046200|OG003|Outcome|IVM 30mg (BrAC = 0.00)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
11178257|NCT02046200|OG004|Outcome|IVM 30mg (BrAC = 0.04)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
11178258|NCT02046200|OG005|Outcome|IVM 30mg (BrAC = 0.08)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
11178259|NCT02046200|OG000|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
11178260|NCT02046200|EG000|Reported Event|IVM 30mg|"Ivermectin 30 mg single dose~Ivermectin: Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.~Alcohol"
11178261|NCT02046200|EG001|Reported Event|Placebo|"Matched placebo, single dose~Placebo: sugar pill~Alcohol"
11178262|NCT02046265|BG000|Baseline|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178263|NCT02046265|BG001|Baseline|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178264|NCT02046265|BG002|Baseline|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178265|NCT02046265|BG003|Baseline|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
10950371|NCT00809055|BG000|Baseline|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
10950372|NCT00809055|BG001|Baseline|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
10950373|NCT00809055|BG002|Baseline|Total|Total of all reporting groups
11178266|NCT02046265|BG004|Baseline|Total|Total of all reporting groups
11178267|NCT02046265|FG000|Participant Flow|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178268|NCT02046265|FG001|Participant Flow|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
10950374|NCT00809055|FG000|Participant Flow|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
10950375|NCT00809055|FG001|Participant Flow|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
10950376|NCT00809055|OG000|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
10950377|NCT00809055|OG001|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
10950378|NCT00809055|EG000|Reported Event|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
10950379|NCT00809055|EG001|Reported Event|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
10950380|NCT00809094|BG000|Baseline|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
10950381|NCT00809094|BG001|Baseline|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
10950382|NCT00809094|BG002|Baseline|Total|Total of all reporting groups
10950383|NCT00809094|FG000|Participant Flow|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
10950384|NCT00809094|FG001|Participant Flow|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
10950385|NCT00809094|OG000|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
11178269|NCT02046265|FG002|Participant Flow|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
10950386|NCT00809094|OG001|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
10950387|NCT00809094|EG000|Reported Event|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
10950388|NCT00809094|EG001|Reported Event|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
10950389|NCT00809133|BG000|Baseline|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950390|NCT00809133|BG001|Baseline|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950391|NCT00809133|BG002|Baseline|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950392|NCT00809133|BG003|Baseline|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950393|NCT00809133|BG004|Baseline|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950394|NCT00809133|BG005|Baseline|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950395|NCT00809133|BG006|Baseline|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950396|NCT00809133|BG007|Baseline|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950397|NCT00809133|BG008|Baseline|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950398|NCT00809133|BG009|Baseline|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950399|NCT00809133|BG010|Baseline|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950400|NCT00809133|BG011|Baseline|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950401|NCT00809133|BG012|Baseline|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950402|NCT00809133|BG013|Baseline|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950403|NCT00809133|BG014|Baseline|Total|Total of all reporting groups
10950404|NCT00809133|FG000|Participant Flow|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950405|NCT00809133|FG001|Participant Flow|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950406|NCT00809133|FG002|Participant Flow|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950407|NCT00809133|FG003|Participant Flow|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950408|NCT00809133|FG004|Participant Flow|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950409|NCT00809133|FG005|Participant Flow|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950410|NCT00809133|FG006|Participant Flow|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950411|NCT00809133|FG007|Participant Flow|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950412|NCT00809133|FG008|Participant Flow|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950413|NCT00809133|FG009|Participant Flow|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950414|NCT00809133|FG010|Participant Flow|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950415|NCT00809133|FG011|Participant Flow|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950416|NCT00809133|FG012|Participant Flow|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950417|NCT00809133|FG013|Participant Flow|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950418|NCT00809133|OG000|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950419|NCT00809133|OG001|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950420|NCT00809133|OG002|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950421|NCT00809133|OG003|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950422|NCT00809133|OG004|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950423|NCT00809133|OG005|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950424|NCT00809133|OG006|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950425|NCT00809133|OG007|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950426|NCT00809133|OG008|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950427|NCT00809133|OG009|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950428|NCT00809133|OG010|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950429|NCT00809133|OG011|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950430|NCT00809133|OG012|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950431|NCT00809133|OG013|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950432|NCT00809133|OG000|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950433|NCT00809133|OG001|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950434|NCT00809133|OG002|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950435|NCT00809133|OG003|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950436|NCT00809133|OG004|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
11178270|NCT02046265|FG003|Participant Flow|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
10950437|NCT00809133|OG000|Outcome|Part B: End of 1st Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
10950438|NCT00809133|OG001|Outcome|Part B: End of 2nd Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
10950439|NCT00809133|OG000|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950440|NCT00809133|OG001|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950441|NCT00809133|OG000|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950442|NCT00809133|OG001|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950443|NCT00809133|OG002|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950444|NCT00809133|OG003|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950445|NCT00809133|EG000|Reported Event|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950446|NCT00809133|EG001|Reported Event|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950447|NCT00809133|EG002|Reported Event|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
10950448|NCT00809133|EG003|Reported Event|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
11178271|NCT02046265|OG000|Outcome|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178272|NCT02046265|OG001|Outcome|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178273|NCT02046265|OG002|Outcome|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178274|NCT02046265|OG003|Outcome|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178275|NCT02046265|EG000|Reported Event|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
10950449|NCT00809133|EG004|Reported Event|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950450|NCT00809133|EG005|Reported Event|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
11178276|NCT02046265|EG001|Reported Event|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178277|NCT02046265|EG002|Reported Event|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11178278|NCT02046265|EG003|Reported Event|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
11192227|NCT02137837|OG002|Outcome|Arm 3: Fulvestrant + Everolimus + Anastrozole|"Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)~Fulvestrant~Anastrozole~Everolimus"
11178279|NCT02046317|BG000|Baseline|Echogenic Needle|"The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures~Echogenic needle: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
11178280|NCT02046317|BG001|Baseline|Standard of Care Needle|"The control group will receive ultrasound-guided femoral nerve block using standard of care needles.~Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures~Standard of care needle: The control group will receive ultrasound-guided femoral nerve block using standard of care needles.~Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
11178281|NCT02046317|BG002|Baseline|Total|Total of all reporting groups
11178282|NCT02046317|FG000|Participant Flow|Echogenic Needle|"The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures~Echogenic needle: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
11178283|NCT02046317|FG001|Participant Flow|Standard of Care Needle|"The control group will receive ultrasound-guided femoral nerve block using standard of care needles.~Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures~Standard of care needle: The control group will receive ultrasound-guided femoral nerve block using standard of care needles.~Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
10950451|NCT00809133|EG006|Reported Event|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950452|NCT00809133|EG007|Reported Event|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
10950453|NCT00809133|EG008|Reported Event|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950454|NCT00809133|EG009|Reported Event|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
10950455|NCT00809133|EG010|Reported Event|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950456|NCT00809133|EG011|Reported Event|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950457|NCT00809133|EG012|Reported Event|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950458|NCT00809133|EG013|Reported Event|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
10950459|NCT00809146|BG000|Baseline|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
10950460|NCT00809146|BG001|Baseline|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
10950461|NCT00809146|BG002|Baseline|Total|Total of all reporting groups
10950462|NCT00809146|FG000|Participant Flow|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
10950463|NCT00809146|FG001|Participant Flow|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
10950464|NCT00809146|OG000|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
10950465|NCT00809146|OG001|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
10950466|NCT00809146|EG000|Reported Event|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
10950467|NCT00809146|EG001|Reported Event|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
10950468|NCT00809159|BG000|Baseline|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10950469|NCT00809159|BG001|Baseline|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950470|NCT00809159|BG002|Baseline|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950471|NCT00809159|BG003|Baseline|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
10950472|NCT00809159|BG004|Baseline|Total|Total of all reporting groups
10950473|NCT00809159|FG000|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
10950474|NCT00809159|FG001|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
10950475|NCT00809159|FG002|Participant Flow|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10950476|NCT00809159|FG003|Participant Flow|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950477|NCT00809159|FG004|Participant Flow|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950478|NCT00809159|FG005|Participant Flow|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
10950479|NCT00809159|OG000|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
10950480|NCT00809159|OG001|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
10950481|NCT00809159|OG000|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
10950482|NCT00809159|OG001|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950483|NCT00809159|OG002|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950484|NCT00809159|OG003|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
10950485|NCT00809159|OG000|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950486|NCT00809159|OG001|Outcome|Part 1 and 2 - AIN457 1.0 mg/Kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950487|NCT00809159|EG000|Reported Event|AIN457 2x10mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950488|NCT00809159|EG001|Reported Event|AIN457 2x1.0mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950489|NCT00809159|EG002|Reported Event|AIN457 2x0.1mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
10950490|NCT00809159|EG003|Reported Event|Placebo|Placebo to AIN457A was administered intravenously as a single dose
10950491|NCT00809185|BG000|Baseline|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
10950492|NCT00809185|FG000|Participant Flow|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
10950493|NCT00809185|OG000|Outcome|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
10950494|NCT00809185|OG000|Outcome|RAD001 (Everolimus)|"RAD001 (everolimus) at 10mg/day with Bone marrow aspirate/biopsy and other laboratory biomarker analysis~everolimus: Patients will receive monotherapy with RAD001(everolimus)for 21 days within the 28 day cycle.~laboratory biomarker analysis: Laboratory correlates (cytotoxic t cell populations, S6K1 levels, GSTT-1 mutations, and the presence or absence of HLA-DR15) will be assessed to see if any of these correlates correspond to response.~Bone marrow aspirate/biopsy: Bone marrow aspirate and biopsy with cytogenetics should be obtained within 4 weeks prior to starting drug and at week 33. A bone marrow aspirate and biopsy should also be obtained for patients going off study prior to week 33 (including cytogenetics). The percentage of blasts on the aspirate should be used to determine the IPSS score."
10950495|NCT00809185|EG000|Reported Event|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
10950496|NCT00809276|BG000|Baseline|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
10950497|NCT00809276|FG000|Participant Flow|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
10950498|NCT00809276|OG000|Outcome|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
10950499|NCT00809276|EG000|Reported Event|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
11178284|NCT02046317|OG000|Outcome|Echogenic Needle|"The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures~Echogenic needle: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
11178285|NCT02046317|OG001|Outcome|Standard of Care Needle|"The control group will receive ultrasound-guided femoral nerve block using standard of care needles.~Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures~Standard of care needle: The control group will receive ultrasound-guided femoral nerve block using standard of care needles.~Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
10950500|NCT00809328|BG000|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
10950501|NCT00809328|FG000|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
10950502|NCT00809328|OG000|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
10950503|NCT00809328|EG000|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
10950504|NCT00809354|BG000|Baseline|Tanezumab 5 mg (Naproxen Exposure)|Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
10950505|NCT00809354|BG001|Baseline|Tanezumab 10 mg (Naproxen Exposure)|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
10950506|NCT00809354|BG002|Baseline|Tanezumab 5 mg + Naproxen 500 mg|Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950507|NCT00809354|BG003|Baseline|Tanezumab 10 mg + Naproxen 500 mg|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950508|NCT00809354|BG004|Baseline|Naproxen 500 mg|Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
11192228|NCT02137837|EG000|Reported Event|Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Placebo - Anastrozole~Placebo - Everolimus"
10950509|NCT00809354|BG005|Baseline|Tanezumab 5 mg (Celecoxib Exposure)|Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
10950510|NCT00809354|BG006|Baseline|Tanezumab 10 mg (Celecoxib Exposure)|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
10950511|NCT00809354|BG007|Baseline|Tanezumab 5 mg + Celecoxib 100 mg|Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950512|NCT00809354|BG008|Baseline|Tanezumab 10 mg + Celecoxib 100 mg|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950513|NCT00809354|BG009|Baseline|Celecoxib 100 mg|Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
10950514|NCT00809354|BG010|Baseline|Total|Total of all reporting groups
10950515|NCT00809354|FG000|Participant Flow|Tanezumab 5 mg (Naproxen Exposure)|Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
10950516|NCT00809354|FG001|Participant Flow|Tanezumab 10 mg (Naproxen Exposure)|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
10950517|NCT00809354|FG002|Participant Flow|Tanezumab 5 mg + Naproxen 500 mg|Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950518|NCT00809354|FG003|Participant Flow|Tanezumab 10 mg + Naproxen 500 mg|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950519|NCT00809354|FG004|Participant Flow|Naproxen 500 mg|Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
10950520|NCT00809354|FG005|Participant Flow|Tanezumab 5 mg (Celecoxib Exposure)|Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
10950521|NCT00809354|FG006|Participant Flow|Tanezumab 10 mg (Celecoxib Exposure)|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
10950522|NCT00809354|FG007|Participant Flow|Tanezumab 5 mg + Celecoxib 100 mg|Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950523|NCT00809354|FG008|Participant Flow|Tanezumab 10 mg + Celecoxib 100 mg|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950524|NCT00809354|FG009|Participant Flow|Celecoxib 100 mg|Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
10950525|NCT00809354|OG000|Outcome|Tanezumab 5 mg (Naproxen Exposure)|Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
10950526|NCT00809354|OG001|Outcome|Tanezumab 10 mg (Naproxen Exposure)|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
10950527|NCT00809354|OG002|Outcome|Tanezumab 5 mg + Naproxen 500 mg|Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950528|NCT00809354|OG003|Outcome|Tanezumab 10 mg + Naproxen 500 mg|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950529|NCT00809354|OG004|Outcome|Naproxen 500 mg|Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
10950530|NCT00809354|OG005|Outcome|Tanezumab 5 mg (Celecoxib Exposure)|Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
10950531|NCT00809354|OG006|Outcome|Tanezumab 10 mg (Celecoxib Exposure)|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
10950532|NCT00809354|OG007|Outcome|Tanezumab 5 mg + Celecoxib 100 mg|Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950533|NCT00809354|OG008|Outcome|Tanezumab 10 mg + Celecoxib 100 mg|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950534|NCT00809354|OG009|Outcome|Celecoxib 100 mg|Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
10950535|NCT00809354|OG000|Outcome|Tanezumab 5 mg (Naproxen or Celecoxib Exposure)|Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
10950536|NCT00809354|OG001|Outcome|Tanezumab 10 mg (Naproxen or Celecoxib Exposure)|Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
10950537|NCT00809354|OG002|Outcome|Tanezumab 5 mg + NSAID|Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
10950538|NCT00809354|OG003|Outcome|Tanezumab 10 mg + NSAID|Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
10950539|NCT00809354|OG004|Outcome|NSAID|Placebo matched to tanezumab infusion, IV once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
10950540|NCT00809354|EG000|Reported Event|Tanezumab 5 mg (Naproxen Exposure)|Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
10950541|NCT00809354|EG001|Reported Event|Tanezumab 10 mg (Naproxen Exposure)|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
10950542|NCT00809354|EG002|Reported Event|Tanezumab 5 mg + Naproxen 500 mg|Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950543|NCT00809354|EG003|Reported Event|Tanezumab 10 mg + Naproxen 500 mg|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950544|NCT00809354|EG004|Reported Event|Naproxen 500 mg|Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
10950545|NCT00809354|EG005|Reported Event|Tanezumab 5 mg (Celecoxib Exposure)|Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
10950546|NCT00809354|EG006|Reported Event|Tanezumab 10 mg (Celecoxib Exposure)|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
10950547|NCT00809354|EG007|Reported Event|Tanezumab 5 mg + Celecoxib 100 mg|Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950548|NCT00809354|EG008|Reported Event|Tanezumab 10 mg + Celecoxib 100 mg|Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
10950549|NCT00809354|EG009|Reported Event|Celecoxib 100 mg|Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
10950550|NCT00809445|BG000|Baseline|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
10950551|NCT00809445|BG001|Baseline|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
10950552|NCT00809445|BG002|Baseline|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
10950553|NCT00809445|BG003|Baseline|Total|Total of all reporting groups
10950554|NCT00809445|FG000|Participant Flow|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
10950555|NCT00809445|FG001|Participant Flow|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
10950556|NCT00809445|FG002|Participant Flow|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
10950557|NCT00809445|OG000|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
10950558|NCT00809445|OG001|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
10950559|NCT00809445|OG002|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
10950560|NCT00809445|EG000|Reported Event|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
10950561|NCT00809445|EG001|Reported Event|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
10950562|NCT00809445|EG002|Reported Event|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
10950563|NCT00809471|BG000|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10950564|NCT00809471|BG001|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
11178286|NCT02046317|EG000|Reported Event|Echogenic Needle|"The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures~Echogenic needle: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
10950565|NCT00809471|BG002|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10950566|NCT00809471|BG003|Baseline|Total|Total of all reporting groups
10950567|NCT00809471|FG000|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10950568|NCT00809471|FG001|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10950569|NCT00809471|FG002|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10950570|NCT00809471|OG000|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10950571|NCT00809471|OG001|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10950572|NCT00809471|OG002|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10950573|NCT00809471|EG000|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10950574|NCT00809471|EG001|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10950575|NCT00809471|EG002|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10950576|NCT00809523|BG000|Baseline|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
10950577|NCT00809523|BG001|Baseline|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
10950578|NCT00809523|BG002|Baseline|Total|Total of all reporting groups
10950579|NCT00809523|FG000|Participant Flow|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
10950580|NCT00809523|FG001|Participant Flow|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
10950581|NCT00809523|OG000|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
10950582|NCT00809523|OG001|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
10950583|NCT00809523|EG000|Reported Event|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
10950584|NCT00809523|EG001|Reported Event|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
10950585|NCT00809614|BG000|Baseline|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
10950586|NCT00809614|BG001|Baseline|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
10950587|NCT00809614|BG002|Baseline|Total|Total of all reporting groups
10950588|NCT00809614|FG000|Participant Flow|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
10950589|NCT00809614|FG001|Participant Flow|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
10950590|NCT00809614|OG000|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
10950591|NCT00809614|OG001|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
10950592|NCT00809614|EG000|Reported Event|AIN457 2x10mg/kg|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
10950593|NCT00809614|EG001|Reported Event|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
10950594|NCT00809757|BG000|Baseline|Placebo|Placebo Placebo MDI TID
10950595|NCT00809757|BG001|Baseline|Levalbuterol MDI|Levalbuterol MDI TID
10950596|NCT00809757|BG002|Baseline|Levalbuterol UDV|Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
10950597|NCT00809757|BG003|Baseline|Total|Total of all reporting groups
10950598|NCT00809757|FG000|Participant Flow|Placebo|Placebo: Placebo (2 actuations)
10950599|NCT00809757|FG001|Participant Flow|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)~Levalbuterol: 90 ug Levalbuterol (2 actuations)"
10950600|NCT00809757|FG002|Participant Flow|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID~Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
10950601|NCT00809757|OG000|Outcome|Placebo|Placebo: Placebo (2 actuations)
10950602|NCT00809757|OG001|Outcome|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)~Levalbuterol: 90 ug Levalbuterol (2 actuations)"
10950603|NCT00809757|OG002|Outcome|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID~Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
10950604|NCT00809757|OG000|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
10950605|NCT00809757|OG001|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
10950606|NCT00809757|OG002|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
10950607|NCT00809757|OG002|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
10950608|NCT00809757|OG000|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
10950609|NCT00809757|OG002|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
10950610|NCT00809757|EG000|Reported Event|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
10950611|NCT00809757|EG001|Reported Event|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
10950612|NCT00809757|EG002|Reported Event|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
10950613|NCT00809783|BG000|Baseline|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950614|NCT00809783|BG001|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950615|NCT00809783|BG002|Baseline|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950616|NCT00809783|BG003|Baseline|Total|Total of all reporting groups
10950617|NCT00809783|FG000|Participant Flow|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950618|NCT00809783|FG001|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950619|NCT00809783|FG002|Participant Flow|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950620|NCT00809783|OG000|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950621|NCT00809783|OG001|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950622|NCT00809783|OG002|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950623|NCT00809783|EG000|Reported Event|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950624|NCT00809783|EG001|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950625|NCT00809783|EG002|Reported Event|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
10950626|NCT00809809|BG000|Baseline|Active Treatment|Active medication - Zinc Swabs
10950627|NCT00809809|BG001|Baseline|Placebo Treatment|Placebo medication - Swabs identical to medication group
10950628|NCT00809809|BG002|Baseline|Total|Total of all reporting groups
10950629|NCT00809809|FG000|Participant Flow|Active Treatment|Active medication - Zinc Swabs
10950630|NCT00809809|FG001|Participant Flow|Placebo Treatment|Placebo medication - Swabs identical to medication group
10950631|NCT00809809|OG000|Outcome|Active Treatment|Active medication - Zinc Swabs
10950632|NCT00809809|OG001|Outcome|Placebo Treatment|Placebo medication - Swabs identical to medication group
10950633|NCT00809809|EG000|Reported Event|Active Treatment|Active medication - Zinc Swabs
10950634|NCT00809809|EG001|Reported Event|Placebo Treatment|Placebo medication - Swabs identical to medication group
10950635|NCT00809835|BG000|Baseline|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
10950636|NCT00809835|BG001|Baseline|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
10950637|NCT00809835|BG002|Baseline|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
10950638|NCT00809835|BG003|Baseline|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
10950639|NCT00809835|BG004|Baseline|Total|Total of all reporting groups
10950640|NCT00809835|FG000|Participant Flow|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
10950641|NCT00809835|FG001|Participant Flow|Galantamine Only|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
10950642|NCT00809835|FG002|Participant Flow|Placebo and CBT|TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
10950643|NCT00809835|FG003|Participant Flow|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
10950644|NCT00809835|OG000|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
10950645|NCT00809835|OG001|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
10950646|NCT00809835|OG002|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
10950647|NCT00809835|OG003|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
10950648|NCT00809835|EG000|Reported Event|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
10950649|NCT00809835|EG001|Reported Event|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
10950650|NCT00809835|EG002|Reported Event|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
10950651|NCT00809835|EG003|Reported Event|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
10950652|NCT00809848|BG000|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
10950653|NCT00809848|BG001|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
10950654|NCT00809848|BG002|Baseline|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
10950655|NCT00809848|BG003|Baseline|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
11178287|NCT02046317|EG001|Reported Event|Standard of Care Needle|"The control group will receive ultrasound-guided femoral nerve block using standard of care needles.~Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures~Standard of care needle: The control group will receive ultrasound-guided femoral nerve block using standard of care needles.~Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
11178288|NCT02046369|BG000|Baseline|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
10950656|NCT00809848|BG004|Baseline|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
10950657|NCT00809848|BG005|Baseline|Total|Total of all reporting groups
10950658|NCT00809848|FG000|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
10950659|NCT00809848|FG001|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
10950660|NCT00809848|FG002|Participant Flow|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
10950661|NCT00809848|FG003|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
10950662|NCT00809848|FG004|Participant Flow|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
10950663|NCT00809848|OG000|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
10950664|NCT00809848|OG001|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
10950665|NCT00809848|OG002|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
10950666|NCT00809848|OG003|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
10950667|NCT00809848|OG004|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
10950668|NCT00809848|OG000|Outcome|AGN 210669 Non-preserved Ophthalmic Solution, 0.075%|AGN 210669 non-preserved ophthalmic solution, 0.075%. One drop in each eye each morning once-daily for 2 weeks.
10950669|NCT00809848|EG000|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
10950670|NCT00809848|EG001|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
10950671|NCT00809848|EG002|Reported Event|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
11178289|NCT02046369|BG001|Baseline|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
11178290|NCT02046369|BG002|Baseline|Total|Total of all reporting groups
11178291|NCT02046369|FG000|Participant Flow|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
10950672|NCT00809848|EG003|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
10950673|NCT00809848|EG004|Reported Event|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
10950674|NCT00809926|BG000|Baseline|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
10950675|NCT00809926|BG001|Baseline|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
10950676|NCT00809926|BG002|Baseline|Total|Total of all reporting groups
10950677|NCT00809926|FG000|Participant Flow|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
10950678|NCT00809926|FG001|Participant Flow|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
10950679|NCT00809926|OG000|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
10950680|NCT00809926|OG001|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
10950681|NCT00809926|EG000|Reported Event|Valsartan/ Aliskiren|Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
10950682|NCT00809926|EG001|Reported Event|Valsartan|Valsartan (160mg) for 2weeks followed by forced titration toValsartan (320mg) for the remaining 6 weeks
10950683|NCT00809965|BG000|Baseline|Placebo|One placebo tablet twice daily
10950684|NCT00809965|BG001|Baseline|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
10950685|NCT00809965|BG002|Baseline|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
10950686|NCT00809965|BG003|Baseline|Total|Total of all reporting groups
10950687|NCT00809965|FG000|Participant Flow|Placebo|One placebo tablet twice daily
10950688|NCT00809965|FG001|Participant Flow|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
10950689|NCT00809965|FG002|Participant Flow|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
10950690|NCT00809965|OG000|Outcome|Placebo|One placebo tablet twice daily
10950691|NCT00809965|OG001|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
10950692|NCT00809965|OG002|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
10950693|NCT00809965|EG000|Reported Event|Placebo|One placebo tablet twice daily
10950694|NCT00809965|EG001|Reported Event|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
10950695|NCT00809965|EG002|Reported Event|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
10950696|NCT00810043|BG000|Baseline|Curette-First|Use of the curette prior to use of the inflatable bone tamps
10950697|NCT00810043|BG001|Baseline|IBT-First|Use of the inflatable bone tamps prior to using the curette
10950698|NCT00810043|BG002|Baseline|Total|Total of all reporting groups
10950699|NCT00810043|FG000|Participant Flow|Curette-First|Use of the curette prior to use of the inflatable bone tamps
10950700|NCT00810043|FG001|Participant Flow|IBT-First|Use of the inflatable bone tamps prior to using the curette
11178292|NCT02046369|FG001|Participant Flow|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
11178293|NCT02046369|OG000|Outcome|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
11178294|NCT02046369|OG001|Outcome|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
11178295|NCT02046369|EG000|Reported Event|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
11178296|NCT02046369|EG001|Reported Event|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
10950701|NCT00810043|FG002|Participant Flow|Non-treated Patients|Patients who met the enrollment criteria at screening who had terminated prior to surgery or those who no longer met the inclusion criteria due to new fractures prior to surgery. These patients were never randomized to treatment because randomization was performed in the operating room.
10950702|NCT00810043|OG000|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
10950703|NCT00810043|OG001|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
10950704|NCT00810043|OG000|Outcome|Curette-First|Use of the curette prior to use of the inflatable bone tamps
10950705|NCT00810043|OG001|Outcome|IBT-First|Use of the inflatable bone tamps prior to using the curette
10950706|NCT00810043|OG000|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
10950707|NCT00810043|EG000|Reported Event|Curette-First|Use of the curette prior to use of the inflatable bone tamps
10950708|NCT00810043|EG001|Reported Event|IBT-First|Use of the inflatable bone tamps prior to using the curette
10950709|NCT00810069|BG000|Baseline|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
10950710|NCT00810069|BG001|Baseline|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
10950711|NCT00810069|BG002|Baseline|Total|Total of all reporting groups
10950712|NCT00810069|FG000|Participant Flow|Escitalopram (Acute Treatment)|Escitalopram 10 milligrams (mg) per day for 4 weeks
10950713|NCT00810069|FG001|Participant Flow|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
10950714|NCT00810069|FG002|Participant Flow|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
10950715|NCT00810069|OG000|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
11178297|NCT02046382|BG000|Baseline|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
10950716|NCT00810069|OG001|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
10950717|NCT00810069|EG000|Reported Event|Escitalopram (Acute Treatment)|Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule)
10950718|NCT00810069|EG001|Reported Event|Delayed Intervention (Double Blind)|Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule[s]). Then, non-responders switched to duloxetine 60 or 120 mg per day for 8 weeks, and responders continued on escitalopram 10 to 20 mg per day for 8 weeks.
10950719|NCT00810069|EG002|Reported Event|Early Intervention (Double Blind)|Duloxetine flexible dose (60 or 120 milligram [mg] daily) for 12 weeks.
10950720|NCT00810069|EG003|Reported Event|Delayed Intervention Responders|Escitalopram 10 to 20 mg per day for 8 weeks.
10950721|NCT00810069|EG004|Reported Event|Delayed Intervention Non-Responders|Duloxetine 60 or 120 mg per day for 8 weeks.
10950722|NCT00810082|BG000|Baseline|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
10950723|NCT00810082|BG001|Baseline|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
10950724|NCT00810082|BG002|Baseline|Total|Total of all reporting groups
10950725|NCT00810082|FG000|Participant Flow|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
10950726|NCT00810082|FG001|Participant Flow|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
10950727|NCT00810082|OG000|Outcome|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
10950728|NCT00810082|OG001|Outcome|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
10950729|NCT00810082|EG000|Reported Event|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
10950730|NCT00810082|EG001|Reported Event|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
10950731|NCT00810095|BG000|Baseline|Treatment Group|All participants treated with the Test System
10950732|NCT00810095|FG000|Participant Flow|MindFrame System Treatment Group|All participants with acute ischemic stroke who were treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. The first generation MindFrame System was a self-expanding nitinol stent retriever mounted on a hypotube delivery wire and delivered to the occlusion site via a 0.027 inch microcatheter. Eligible patients were aged 18-80 years, had a baseline NIHSS score of 6-30, had a thrombotic occlusion of the ICA, MCA (M1 or M2) or basilar arteries, and could be treated within 6 hours of stroke onset.
10950733|NCT00810095|OG000|Outcome|Treatment Group|All participants treated with the Test System
10950734|NCT00810095|EG000|Reported Event|Treatment Group|All participants treated with the Test System
10950735|NCT00810108|BG000|Baseline|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
10950736|NCT00810108|BG001|Baseline|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
10950737|NCT00810108|BG002|Baseline|Total|Total of all reporting groups
10950738|NCT00810108|FG000|Participant Flow|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
10950739|NCT00810108|FG001|Participant Flow|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
10950740|NCT00810108|OG000|Outcome|All Subjects Taking Whole Tablets|Lopinavir AUC from all subjects taking the whole tablet
10950741|NCT00810108|OG001|Outcome|All Subjects Taking Crushed Tablets|Lopinavir AUC from all subjects taking the crushed tablet
10950742|NCT00810108|EG000|Reported Event|All Subjects|Data from all subjects combined
10950743|NCT00810199|BG000|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
10950744|NCT00810199|BG001|Baseline|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
10950745|NCT00810199|BG002|Baseline|Total|Total of all reporting groups
10950746|NCT00810199|FG000|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
10950747|NCT00810199|FG001|Participant Flow|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
10950748|NCT00810199|OG000|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
10950749|NCT00810199|OG001|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
10950750|NCT00810199|OG000|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
10950751|NCT00810199|OG001|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
10950752|NCT00810199|OG000|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
10950753|NCT00810199|OG001|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
10950754|NCT00810199|OG000|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
10950755|NCT00810199|OG001|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added
10950756|NCT00810199|EG000|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
10950757|NCT00810199|EG001|Reported Event|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
10950758|NCT00810264|BG000|Baseline|BIOTRONIK Corox BP LV Lead|Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
10950759|NCT00810264|FG000|Participant Flow|BIOTRONIK Corox BP LV Lead|Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
10950760|NCT00810264|OG000|Outcome|BIOTRONIK Corox BP LV Lead|Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
10950761|NCT00810264|OG000|Outcome|BIOTRONIK Corox BP LV Lead|Subjects consented and implanted with a BIOTRONIK Corox BP LV lead completing an in-office 5 year visit.
10950762|NCT00810264|OG000|Outcome|Corox OTW BP|Subjects consented and originally implanted with a Corox OTW BP lead.
10950763|NCT00810264|OG001|Outcome|Corox OTW-S BP|Subjects consented and originally implanted with a Corox OTW-S BP lead.
10950764|NCT00810264|OG002|Outcome|Corox OTW-L BP|Subjects consented and originally implanted with a Corox OTW-L BP lead.
10950765|NCT00810264|EG000|Reported Event|BIOTRONIK Corox BP LV Lead|Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
10950766|NCT00810277|BG000|Baseline|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
10950767|NCT00810277|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
10950768|NCT00810277|OG000|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
11178298|NCT02046382|BG001|Baseline|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
10950769|NCT00810277|EG000|Reported Event|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
10950770|NCT00810303|BG000|Baseline|Study Group|whole study group: 12 healthy subjects
10950771|NCT00810303|FG000|Participant Flow|Study Group|whole study group: 12 healthy subjects
10950772|NCT00810303|OG000|Outcome|Study Group|whole study group: 12 healthy subjects
10950773|NCT00810303|EG000|Reported Event|Study Group|whole study group: 12 healthy subjects
10950774|NCT00810303|EG001|Reported Event|Efavirenz Alone Single Dose|
10950775|NCT00810303|EG002|Reported Event|Ezetimibe Alone Multiple Dose|
10950776|NCT00810303|EG003|Reported Event|Ezetimibe Multiple Dose and Efavirenz Single Dose|
10950777|NCT00810303|EG004|Reported Event|Ezetimibe and Efavirenz Multiple Dose|
10950778|NCT00810342|BG000|Baseline|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
10950779|NCT00810342|BG001|Baseline|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
10950780|NCT00810342|BG002|Baseline|Total|Total of all reporting groups
10950781|NCT00810342|FG000|Participant Flow|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
10950782|NCT00810342|FG001|Participant Flow|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
10950783|NCT00810342|OG000|Outcome|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
10950784|NCT00810342|OG001|Outcome|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
10950785|NCT00810342|OG000|Outcome|1- Physical Activity Tailored|"Tailored telephone counseling about how to become more physically active and goal setting. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
10950786|NCT00810342|OG001|Outcome|2 - Physical Activity Standard|"Standard Website resources / information on physical activity~physical activity standard: standard print and website information on how to become more active"
10950787|NCT00810342|EG000|Reported Event|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
10950788|NCT00810342|EG001|Reported Event|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
10950789|NCT00810355|BG000|Baseline|Support Group|"Support group~Support Group: General support and problem solving for work activity"
10950790|NCT00810355|BG001|Baseline|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
10950791|NCT00810355|BG002|Baseline|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
11178299|NCT02046382|BG002|Baseline|Total|Total of all reporting groups
11178300|NCT02046382|FG000|Participant Flow|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
11178301|NCT02046382|FG001|Participant Flow|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
10950792|NCT00810355|BG003|Baseline|Total|Total of all reporting groups
10950793|NCT00810355|FG000|Participant Flow|Support Group|Support Group: General support and problem solving for work activity
10950794|NCT00810355|FG001|Participant Flow|Cognitive Behavior Therapy|Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
10950795|NCT00810355|FG002|Participant Flow|Cognitive Behavior Therapy and Cognitive Remediation|"Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
10950796|NCT00810355|OG000|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
10950797|NCT00810355|OG001|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
10950798|NCT00810355|OG002|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
10950799|NCT00810355|EG000|Reported Event|Support Group|"Support group~Support Group: General support and problem solving for work activity"
10950800|NCT00810355|EG001|Reported Event|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
10950801|NCT00810355|EG002|Reported Event|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
10950802|NCT00810368|BG000|Baseline|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
10950803|NCT00810368|BG001|Baseline|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
10950804|NCT00810368|BG002|Baseline|Total|Total of all reporting groups
10950805|NCT00810368|FG000|Participant Flow|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
10950806|NCT00810368|FG001|Participant Flow|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
11178302|NCT02046382|OG000|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
11178303|NCT02046382|OG001|Outcome|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
11178304|NCT02046382|EG000|Reported Event|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
10950807|NCT00810368|OG000|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
10950808|NCT00810368|OG001|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
10950809|NCT00810368|OG000|Outcome|Carnosine Treatment Group|"Carnosine treatment group~Carnosine: 500mg Carnosine x2 daily"
10950810|NCT00810368|OG001|Outcome|Placebo Control Group|"Placebo control group~Placebo: Microcrystalline cellulose placebo tablets x2 daily"
10950811|NCT00810368|EG000|Reported Event|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
11178305|NCT02046382|EG001|Reported Event|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
11178306|NCT02046525|BG000|Baseline|Auto Fecal Microbitoa Therapy|"autologous fecal microbiota therapy~Autologous fecal microbiota therapy"
11178307|NCT02046525|BG001|Baseline|Saline Enema|"Saline enema~Placebo: Saline enema"
11178308|NCT02046525|BG002|Baseline|Total|Total of all reporting groups
11178309|NCT02046525|FG000|Participant Flow|Auto Fecal Microbitoa Therapy|"autologous fecal microbiota therapy~Autologous fecal microbiota therapy"
11178310|NCT02046525|FG001|Participant Flow|Saline Enema|"Saline enema~Placebo: Saline enema"
11178311|NCT02046525|OG000|Outcome|Auto Fecal Microbiota Therapy|"autologous fecal microbiota therapy~Autologous fecal microbiota therapy"
11178312|NCT02046525|OG001|Outcome|Saline Enema|"Saline enema~Placebo: Saline enema"
11178313|NCT02046525|EG000|Reported Event|Auto Fecal Microbitoa Therapy|"autologous fecal microbiota therapy~Autologous fecal microbiota therapy"
10950812|NCT00810368|EG001|Reported Event|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
10950813|NCT00810394|BG000|Baseline|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
10950814|NCT00810394|FG000|Participant Flow|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
10950815|NCT00810394|OG000|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
10950816|NCT00810394|EG000|Reported Event|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
10950817|NCT00810407|BG000|Baseline|Mycobutin (Rifabutin)|Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
10950818|NCT00810407|FG000|Participant Flow|Mycobutin (Rifabutin)|Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
10950819|NCT00810407|OG000|Outcome|Mycobutin (Rifabutin)|Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
10950820|NCT00810407|EG000|Reported Event|Mycobutin (Rifabutin)|Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
10950821|NCT00810459|BG000|Baseline|All Participants Consented|All participants consented for the study.
10950822|NCT00810459|FG000|Participant Flow|Trilogy Ventilator First, Then Standard of Care Ventilator|These participants used the Trilogy Ventilator first, then Standard of Care Ventilator
10950823|NCT00810459|FG001|Participant Flow|Standard of Care Ventilator First, Then Trilogy Ventilator|Theses participants used the Standard of Care Ventilator first and then Trilogy Ventilator.
10950824|NCT00810459|OG000|Outcome|Trilogy Ventilator|"Trilogy ventilator~Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator"
10950825|NCT00810459|OG001|Outcome|Standard of Care|"Participants currently prescribed ventilator~Standard of Care: Exposure of one hour on the Participants prescribed ventilator"
10950826|NCT00810459|OG000|Outcome|Trilogy Ventilator|"Trilogy ventilator~Trilogy Ventilator: Exposure to one hour on the Trilog ventilator"
10950827|NCT00810459|EG000|Reported Event|Trilogy Ventilator|"Trilogy ventilator~Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator"
10950828|NCT00810459|EG001|Reported Event|Standard of Care Ventilator|"Participants currently prescribed ventilator~Standard of Care: Exposure of one hour on the Participants prescribed ventilator"
10950829|NCT00810498|BG000|Baseline|All Participants Consented|All participants that were consented.
10950830|NCT00810498|FG000|Participant Flow|Trilogy First, Then Standard of Care|These participants used Trilogy first, then Standard of Care.
10950831|NCT00810498|FG001|Participant Flow|Standard of Care First, Then Trilogy|these participants used Standard of Care first, then Trilogy.
11178314|NCT02046525|EG001|Reported Event|Saline Enema|"Saline enema~Placebo: Saline enema"
10950832|NCT00810498|OG000|Outcome|Trilogy|"Trilogy Device~Trilogy: Exposure for one hour on the Trilogy ventilator"
10950833|NCT00810498|OG001|Outcome|Standard of Care|"Participants prescribed ventilator~Standard of Care: Exposure to participants current ventilator"
10950834|NCT00810498|EG000|Reported Event|Trilogy Device|"Trilogy Device~Trilogy: Exposure for one hour on the Trilogy ventilator"
10950835|NCT00810498|EG001|Reported Event|Standard of Care|"Participants prescribed ventilator~Standard of Care: Exposure to participants current ventilator"
10950836|NCT00810511|BG000|Baseline|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
10950837|NCT00810511|BG001|Baseline|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
10950838|NCT00810511|BG002|Baseline|Total|Total of all reporting groups
11178315|NCT02046564|BG000|Baseline|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
10950839|NCT00810511|FG000|Participant Flow|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
10950840|NCT00810511|FG001|Participant Flow|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
10950841|NCT00810511|OG000|Outcome|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
10950842|NCT00810511|OG001|Outcome|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
10950843|NCT00810511|EG000|Reported Event|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
10950844|NCT00810511|EG001|Reported Event|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
10950845|NCT00810576|BG000|Baseline|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
10950846|NCT00810576|FG000|Participant Flow|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
10950847|NCT00810576|OG000|Outcome|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
10950848|NCT00810576|EG000|Reported Event|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
10950849|NCT00810602|BG000|Baseline|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
11178316|NCT02046564|BG001|Baseline|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
10950850|NCT00810602|FG000|Participant Flow|Phase 1|In the Phase 1 portion of the study, participants were administered Vorinostat, either 100 mg or 200mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
10950851|NCT00810602|FG001|Participant Flow|Phase 2|100 mg was selected as the Phase 2 dose. Participants were administered Vorinostat, 100 mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
10950852|NCT00810602|OG000|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
10950853|NCT00810602|EG000|Reported Event|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
10950854|NCT00810615|BG000|Baseline|Sham Treatment|Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment leg. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness)at the same frequency as if they were in the treatment exposure pressure.
10950855|NCT00810615|BG001|Baseline|Hyperbaric Oxygen 2.4 ATA|Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations)during the exposure.
10950856|NCT00810615|BG002|Baseline|Total|Total of all reporting groups
10950857|NCT00810615|FG000|Participant Flow|Sham Treatment|Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment pressure. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) at the same frequency as if they were in the treatment exposure pressure.
11178317|NCT02046564|BG002|Baseline|Total|Total of all reporting groups
11178318|NCT02046564|FG000|Participant Flow|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
11178319|NCT02046564|FG001|Participant Flow|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
11178320|NCT02046564|OG000|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
11178321|NCT02046564|OG001|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
10950858|NCT00810615|FG001|Participant Flow|Hyperbaric Oxygen 2.4 ATA|Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations) during the exposure.
10950859|NCT00810615|OG000|Outcome|Sham Treatment|"Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.~Sham treatment"
10950860|NCT00810615|OG001|Outcome|Hyperbaric Oxygen 2.4 ATA|"Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.~Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures."
10950861|NCT00810615|OG000|Outcome|Sham Treatment|Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment pressure. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) at the same frequency as if they were in the treatment exposure pressure.
10950862|NCT00810615|OG001|Outcome|Hyperbaric Oxygen 2.4 ATA|Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations) during the exposure.
10950863|NCT00810615|OG000|Outcome|Sham Treatment Improved|"Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.~PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950864|NCT00810615|OG001|Outcome|Sham Treatment Not Improved|"Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.~PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950865|NCT00810615|OG002|Outcome|Hyperbaric Oxygen 2.4 ATA Improved|"Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.~PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950866|NCT00810615|OG003|Outcome|Hyperbaric Oxygen 2.4 ATA Not Improved|"Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.~PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950867|NCT00810615|OG000|Outcome|Sham Treatment Improved|"Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.~PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950868|NCT00810615|OG001|Outcome|Sham Treatment Not Improved|"Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.~PCL-M composite scores demonstrated a significant (decrease by 9 or less)improvement from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950869|NCT00810615|OG002|Outcome|Hyperbaric Oxygen 2.4 ATA Improved|"Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.~PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950870|NCT00810615|OG003|Outcome|Hyperbaric Oxygen 2.4 ATA Not Improved|"Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.~PCL-M composite scores demonstrated a significant (decrease by 9 or less)improvement from baseline at 30 post hyperbaric exposure or 6 week follow-up."
11178322|NCT02046564|EG000|Reported Event|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
10950871|NCT00810615|OG001|Outcome|Sham Treatment Not Improved|"Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. See previous description for details.~PCL-M composite scores demonstrated a decrease of 9 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950872|NCT00810615|OG003|Outcome|Hyperbaric Oxygen 2.4 ATA Not Improved|"Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.~PCL-M composite scores demonstrated a decrease of 9 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up."
10950873|NCT00810615|EG000|Reported Event|Sham Treatment|Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment pressure. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) at the same frequency as if they were in the treatment exposure pressure.
10950874|NCT00810615|EG001|Reported Event|Hyperbaric Oxygen 2.4 ATA|Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations) during the exposure.
10950875|NCT00810641|BG000|Baseline|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
10950876|NCT00810641|BG001|Baseline|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
10950877|NCT00810641|BG002|Baseline|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
10950878|NCT00810641|BG003|Baseline|Total|Total of all reporting groups
10950879|NCT00810641|FG000|Participant Flow|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
10950880|NCT00810641|FG001|Participant Flow|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
10950881|NCT00810641|FG002|Participant Flow|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
10950882|NCT00810641|OG000|Outcome|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
10950883|NCT00810641|OG001|Outcome|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
11178323|NCT02046564|EG001|Reported Event|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
10950884|NCT00810641|OG002|Outcome|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
10950885|NCT00810641|EG000|Reported Event|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
10950886|NCT00810641|EG001|Reported Event|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
10950887|NCT00810641|EG002|Reported Event|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
10950888|NCT00810693|BG000|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
10950889|NCT00810693|BG001|Baseline|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
10950890|NCT00810693|BG002|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
10950891|NCT00810693|BG003|Baseline|Total|Total of all reporting groups
10950892|NCT00810693|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
10950893|NCT00810693|FG001|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
10950894|NCT00810693|FG002|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
10950895|NCT00810693|OG000|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
11178324|NCT02046603|BG000|Baseline|Tocilizumab Monotherapy|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy for 52 weeks.
10950896|NCT00810693|OG001|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
10950897|NCT00810693|OG002|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
10950898|NCT00810693|EG000|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
10950899|NCT00810693|EG001|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
10950900|NCT00810693|EG002|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
11178325|NCT02046603|BG001|Baseline|Tocilizumab in Combination With Methotrexate or Other DMARDs|Participants received a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks.
11178326|NCT02046603|BG002|Baseline|Total|Total of all reporting groups
11178327|NCT02046603|FG000|Participant Flow|Tocilizumab Monotherapy|Participants received a weekly subcutaneous (SC) injection of tocilizumab 162 milligrams (mg) as monotherapy for 52 weeks.
10950901|NCT00810719|BG000|Baseline|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
10950902|NCT00810719|FG000|Participant Flow|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
10950903|NCT00810719|OG000|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
10950904|NCT00810719|EG000|Reported Event|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
10950905|NCT00810771|BG000|Baseline|Preference-tailored (PT) Intervention|Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
10950906|NCT00810771|BG001|Baseline|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
10950907|NCT00810771|BG002|Baseline|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
10950908|NCT00810771|BG003|Baseline|Total|Total of all reporting groups
10950909|NCT00810771|FG000|Participant Flow|Preference-tailored (PT) Intervention|"Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.~Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
11178328|NCT02046603|FG001|Participant Flow|Tocilizumab in Combination With Methotrexate or Other DMARDs|Participants received a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) for 52 weeks.
11178329|NCT02046603|OG000|Outcome|Tocilizumab Monotherapy|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy for 52 weeks.
11178330|NCT02046603|OG001|Outcome|Tocilizumab in Combination With Methotrexate or Other DMARDs|Participants received a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks.
11178331|NCT02046603|OG000|Outcome|Tocilizumab in Combination With Methotrexate or Other DMARDs|Participants received a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks.
10950910|NCT00810771|FG001|Participant Flow|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
10950911|NCT00810771|FG002|Participant Flow|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
10950912|NCT00810771|OG000|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
10950913|NCT00810771|OG001|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
10950914|NCT00810771|OG002|Outcome|Usual Care|"Usual Care - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening."
10950915|NCT00810771|OG000|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
11178332|NCT02046603|EG000|Reported Event|Tocilizumab Monotherapy|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy for 52 weeks.
11178333|NCT02046603|EG001|Reported Event|Tocilizumab in Combination With Methotrexate or Other DMARDs|Participants received a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks.
11178334|NCT02046616|BG000|Baseline|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
11178335|NCT02046616|FG000|Participant Flow|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 milligrams (mg), irrespective of body weight, administered subcutaneously weekly (QW) for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
10950916|NCT00810771|OG001|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
10950917|NCT00810771|EG000|Reported Event|Preference-tailored (PT) Intervention|Preference-tailored (PT) intervention
10950918|NCT00810771|EG001|Reported Event|Standard Information (SI) Intervention|Standard information (SI) intervention
10950919|NCT00810771|EG002|Reported Event|Usual Care|"Usual Care - due to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm."
10950920|NCT00810797|BG000|Baseline|Treatment (Exemestane)|"Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~exemestane: Given orally~laboratory biomarker analysis: One year after completion of study treatment~quality-of-life assessment: One year after completion of study treatment~immunohistochemistry staining method: Correlative studies"
11178336|NCT02046616|OG000|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
11178337|NCT02046616|EG000|Reported Event|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
11178338|NCT02046772|BG000|Baseline|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
11178339|NCT02046772|BG001|Baseline|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
11178340|NCT02046772|BG002|Baseline|Total|Total of all reporting groups
11178341|NCT02046772|FG000|Participant Flow|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
11178342|NCT02046772|FG001|Participant Flow|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
10950921|NCT00810797|FG000|Participant Flow|Treatment (Exemestane)|"Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~exemestane: Given orally~laboratory biomarker analysis: One year after completion of study treatment~quality-of-life assessment: One year after completion of study treatment~immunohistochemistry staining method: Correlative studies"
10950922|NCT00810797|OG000|Outcome|Treatment (Exemestane)|"Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~exemestane: Given orally~laboratory biomarker analysis: One year after completion of study treatment~quality-of-life assessment: One year after completion of study treatment~immunohistochemistry staining method: Correlative studies"
10950923|NCT00810797|EG000|Reported Event|Treatment (Exemestane)|"Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~exemestane: Given orally~laboratory biomarker analysis: One year after completion of study treatment~quality-of-life assessment: One year after completion of study treatment~immunohistochemistry staining method: Correlative studies"
10950924|NCT00810810|BG000|Baseline|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
10950925|NCT00810810|BG001|Baseline|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950926|NCT00810810|BG002|Baseline|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950927|NCT00810810|BG003|Baseline|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950928|NCT00810810|BG004|Baseline|Total|Total of all reporting groups
10950929|NCT00810810|FG000|Participant Flow|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
10950930|NCT00810810|FG001|Participant Flow|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950931|NCT00810810|FG002|Participant Flow|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950932|NCT00810810|FG003|Participant Flow|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950933|NCT00810810|OG000|Outcome|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
10950934|NCT00810810|OG001|Outcome|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950935|NCT00810810|OG002|Outcome|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
11178343|NCT02046772|OG000|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
10950936|NCT00810810|OG003|Outcome|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950937|NCT00810810|EG000|Reported Event|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
10950938|NCT00810810|EG001|Reported Event|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950939|NCT00810810|EG002|Reported Event|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
10950940|NCT00810810|EG003|Reported Event|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
11178344|NCT02046772|OG001|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
11178345|NCT02046772|EG000|Reported Event|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
10950941|NCT00810888|BG000|Baseline|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
10950942|NCT00810888|BG001|Baseline|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
10950943|NCT00810888|BG002|Baseline|Group 3 - Observation Only Arm|"Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA spot sign negative) will be enrolled into a prospective observational group."
10950944|NCT00810888|BG003|Baseline|Total|Total of all reporting groups
10950945|NCT00810888|FG000|Participant Flow|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
10950946|NCT00810888|FG001|Participant Flow|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
10950947|NCT00810888|FG002|Participant Flow|Group 3 - Observation Only Arm|"Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA spot sign negative) will be enrolled into a prospective observational group."
10950948|NCT00810888|OG000|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
10950949|NCT00810888|OG001|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
10950950|NCT00810888|OG002|Outcome|Group 3 - Observation Only Arm|"Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA spot sign negative) will be enrolled into a prospective observational group."
10950951|NCT00810888|EG000|Reported Event|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
10950952|NCT00810888|EG001|Reported Event|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
10950953|NCT00810888|EG002|Reported Event|Group 3 - Observation Only Arm|"Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA spot sign negative) will be enrolled into a prospective observational group."
10950954|NCT00810901|BG000|Baseline|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
11178346|NCT02046772|EG001|Reported Event|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
11178347|NCT02046863|BG000|Baseline|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
10950955|NCT00810901|BG001|Baseline|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
10950956|NCT00810901|BG002|Baseline|Total|Total of all reporting groups
10950957|NCT00810901|FG000|Participant Flow|Organ Donor|"Intervention used a digital video disk (DVD), text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
10950958|NCT00810901|FG001|Participant Flow|Alcohol Prevention|"Intervention used a digital video disk (DVD) and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
11178348|NCT02046863|FG000|Participant Flow|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
10950959|NCT00810901|OG000|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
10950960|NCT00810901|OG001|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
10950961|NCT00810901|EG000|Reported Event|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
10950962|NCT00810901|EG001|Reported Event|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
10950963|NCT00811018|BG000|Baseline|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
10950964|NCT00811018|FG000|Participant Flow|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
10950965|NCT00811018|OG000|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
10950966|NCT00811018|EG000|Reported Event|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
11178349|NCT02046863|OG000|Outcome|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
10950967|NCT00811057|BG000|Baseline|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
10950968|NCT00811057|BG001|Baseline|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
10950969|NCT00811057|BG002|Baseline|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
10950970|NCT00811057|BG003|Baseline|Total|Total of all reporting groups
10950971|NCT00811057|FG000|Participant Flow|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
10950972|NCT00811057|FG001|Participant Flow|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
10950973|NCT00811057|FG002|Participant Flow|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
10950974|NCT00811057|OG000|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
10950975|NCT00811057|OG001|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
10950976|NCT00811057|OG002|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
10950977|NCT00811057|EG000|Reported Event|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
10950978|NCT00811057|EG001|Reported Event|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
11178350|NCT02046863|EG000|Reported Event|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
10950979|NCT00811057|EG002|Reported Event|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
10950980|NCT00811070|BG000|Baseline|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
10950981|NCT00811070|BG001|Baseline|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
10950982|NCT00811070|BG002|Baseline|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
10950983|NCT00811070|BG003|Baseline|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10950984|NCT00811070|BG004|Baseline|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10950985|NCT00811070|BG005|Baseline|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10950986|NCT00811070|BG006|Baseline|Total|Total of all reporting groups
10950987|NCT00811070|FG000|Participant Flow|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
10950988|NCT00811070|FG001|Participant Flow|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
10950989|NCT00811070|FG002|Participant Flow|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
10950990|NCT00811070|FG003|Participant Flow|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10950991|NCT00811070|FG004|Participant Flow|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10950992|NCT00811070|FG005|Participant Flow|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10950993|NCT00811070|OG000|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
10950994|NCT00811070|OG001|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
10950995|NCT00811070|OG002|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
10950996|NCT00811070|OG000|Outcome|All Treated Participants (Part 1 )|All participants who received single oral dose of bosutinib 400 mg, 500 mg or 600 mg on Day 1 and then bosutinib 400 mg, 500 mg or 600 mg orally once daily continuously from Day 3 up to Week 4.
10950997|NCT00811070|OG000|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10950998|NCT00811070|OG001|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10950999|NCT00811070|OG002|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10951000|NCT00811070|OG000|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10951001|NCT00811070|OG001|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10951002|NCT00811070|OG000|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
10951003|NCT00811070|OG000|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
11178351|NCT02046902|BG000|Baseline|Pre-Implementation|Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.
11178352|NCT02046902|BG001|Baseline|Post-implementation With Decision Coaching|Patients received the consent form, the SDM tool for stent selection, and decision coaching
10951004|NCT00811070|EG000|Reported Event|Total Second-line|All participants who received bosutinib orally once daily in second-line chronic myelogenous leukemia (CML), who were imatinib resistant/refractory/intolerant.
10951005|NCT00811070|EG001|Reported Event|Exploratory Third-line|All participants who received bosutinib 500 mg orally once daily in third-line chronic myelogenous leukemia (CML), participants were with imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant.
10951006|NCT00811070|EG002|Reported Event|Total Population|Total participants who were second-line or third-line chronic myelogenous leukemia (CML).
10951007|NCT00811135|BG000|Baseline|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
10951008|NCT00811135|FG000|Participant Flow|Trastuzumab + Bevacizumab + Capecitabine|Participants received intravenous (IV) trastuzumab (8 milligrams per kilogram [mg/kg]) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 milligrams per meter square (mg/m^2) twice daily (BID) on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
10951009|NCT00811135|OG000|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
10951010|NCT00811135|EG000|Reported Event|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
10951011|NCT00811174|BG000|Baseline|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
10951012|NCT00811174|FG000|Participant Flow|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
10951013|NCT00811174|OG000|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
10951014|NCT00811174|EG000|Reported Event|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
10951015|NCT00811187|BG000|Baseline|Lidocaine Paracervical Block|10 cc of 1% Lidocaine injected in the paracervical region
10951016|NCT00811187|BG001|Baseline|Saline Placebo Injection|10 cc of Normal Saline as placebo injected in paracervical region
10951017|NCT00811187|BG002|Baseline|Total|Total of all reporting groups
10951018|NCT00811187|FG000|Participant Flow|Lidocaine Paracervical Block|10 cc of 1% Lidocaine (10mg) injected in the paracervical region of patient as a single-injection nerve block before their procedure.
10951019|NCT00811187|FG001|Participant Flow|Saline Placebo Injection|10 cc of Normal Saline (10mg) as placebo injected in paracervical region of patient as a single-injection placebo before their procedure.
10951020|NCT00811187|OG000|Outcome|Lidocaine Group|10 cc 1% lidocaine injected in the paracervical region
10951021|NCT00811187|OG001|Outcome|Saline Placebo Group|10 cc of 1% lidocaine injected in the paracervical region
10951022|NCT00811187|EG000|Reported Event|Lidocaine Paracervical Block|10 cc of 1% (10mg) Lidocaine injected in the paracervical region
10951023|NCT00811187|EG001|Reported Event|Saline Placebo Injection|10 cc of Normal Saline (10mg) as placebo injected in paracervical region
10951024|NCT00811252|BG000|Baseline|Placebo|capsules; daily; orally
11178353|NCT02046902|BG002|Baseline|Post-implementation Without Decision Coaching|patients received the consent form and the SDM tool, but no decision coaching
10951025|NCT00811252|BG001|Baseline|Vortioxetine 5 mg|encapsulated tablets; daily; orally
10951026|NCT00811252|BG002|Baseline|Duloxetine 60 mg|encapsulated tablets; daily; orally
10951027|NCT00811252|BG003|Baseline|Total|Total of all reporting groups
10951028|NCT00811252|FG000|Participant Flow|Placebo|capsules; daily; orally
10951029|NCT00811252|FG001|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; daily; orally
10951030|NCT00811252|FG002|Participant Flow|Duloxetine 60 mg|encapsulated tablets; daily; orally
10951031|NCT00811252|OG000|Outcome|Placebo|capsules; daily; orally
10951032|NCT00811252|OG001|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
10951033|NCT00811252|OG002|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
10951034|NCT00811252|EG000|Reported Event|Placebo|
10951035|NCT00811252|EG001|Reported Event|Vortioxetine 5 mg|
10951036|NCT00811252|EG002|Reported Event|Duloxetine 60 mg|
10951037|NCT00811317|BG000|Baseline|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
10951038|NCT00811317|FG000|Participant Flow|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
10951039|NCT00811317|OG000|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
10951040|NCT00811317|EG000|Reported Event|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
10951041|NCT00811382|BG000|Baseline|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC.~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring."
10951042|NCT00811382|BG001|Baseline|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)."
10951043|NCT00811382|BG002|Baseline|Total|Total of all reporting groups
10951044|NCT00811382|FG000|Participant Flow|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
10951045|NCT00811382|FG001|Participant Flow|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
10951046|NCT00811382|OG000|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
10951047|NCT00811382|OG001|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
10951048|NCT00811382|OG000|Outcome|1: Access to HMSC (Home Monitoring Service Center)|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
11178354|NCT02046902|BG003|Baseline|Total|Total of all reporting groups
10951049|NCT00811382|OG001|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
10951050|NCT00811382|EG000|Reported Event|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of cardiac resynchronization therapy and management of atrial fibrillation with a full access for the treating physician to the Home Monitoring Service Center~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
10951051|NCT00811382|EG001|Reported Event|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
10951052|NCT00811395|BG000|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
10951053|NCT00811395|BG001|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
10951054|NCT00811395|BG002|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
10951055|NCT00811395|BG003|Baseline|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
10951056|NCT00811395|BG004|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
10951057|NCT00811395|BG005|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
10951058|NCT00811395|BG006|Baseline|Total|Total of all reporting groups
10951059|NCT00811395|FG000|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
10951060|NCT00811395|FG001|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
10951061|NCT00811395|FG002|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
10951062|NCT00811395|FG003|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
10951063|NCT00811395|FG004|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
10951064|NCT00811395|FG005|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
10951065|NCT00811395|OG000|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
10951066|NCT00811395|OG001|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
10951067|NCT00811395|OG002|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
10951068|NCT00811395|OG003|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
10951069|NCT00811395|OG004|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
10951070|NCT00811395|OG005|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
10951071|NCT00811395|OG003|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
10951072|NCT00811395|OG004|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
10951073|NCT00811395|OG005|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
10951074|NCT00811395|EG000|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
10951075|NCT00811395|EG001|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
10951076|NCT00811395|EG002|Reported Event|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
10951077|NCT00811395|EG003|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
10951078|NCT00811395|EG004|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
10951079|NCT00811395|EG005|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
10951080|NCT00811434|BG000|Baseline|All Participants|all aprticipants who were randomized to receive treatment
10951081|NCT00811434|FG000|Participant Flow|Lactulose First, Then Placebo|Lactulose therapy based on weight; Washout; placebo therapy of 1.5ml/kg/day
10951082|NCT00811434|FG001|Participant Flow|Placebo First, Then Lactulose|Placebo therapy of 1.5ml/kg/day; washout; lactulose therapy based on weight
10951083|NCT00811434|OG000|Outcome|All Randomized Participants|
10951084|NCT00811434|OG000|Outcome|Lactulose|3 months of Lactulose therapy based on pt. weight
10951085|NCT00811434|OG001|Outcome|Placebo|1.5 ml/kg day po of sugar water placebo for three months
10951086|NCT00811434|EG000|Reported Event|Lactulose|3 months of Lactulose therapy based on pt. weight
10951087|NCT00811434|EG001|Reported Event|Placebo|1.5 ml/kg day po of sugar water placebo for three months
10951088|NCT00811473|BG000|Baseline|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
10951089|NCT00811473|BG001|Baseline|Placebo|Matching placebo
10951090|NCT00811473|BG002|Baseline|Total|Total of all reporting groups
10951091|NCT00811473|FG000|Participant Flow|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
10951092|NCT00811473|FG001|Participant Flow|Placebo|Matching placebo
10951093|NCT00811473|OG000|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
10951094|NCT00811473|OG001|Outcome|Placebo|Matching placebo
10951095|NCT00811473|EG000|Reported Event|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
10951096|NCT00811473|EG001|Reported Event|Placebo|Matching placebo
10951097|NCT00811564|BG000|Baseline|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
10951098|NCT00811564|BG001|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
10951099|NCT00811564|BG002|Baseline|Total|Total of all reporting groups
10951100|NCT00811564|FG000|Participant Flow|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
10951101|NCT00811564|FG001|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
10951102|NCT00811564|OG000|Outcome|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
10951103|NCT00811564|OG001|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
10951104|NCT00811564|EG000|Reported Event|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
10951105|NCT00811564|EG001|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
10951106|NCT00811577|BG000|Baseline|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
10951107|NCT00811577|BG001|Baseline|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
10951108|NCT00811577|BG002|Baseline|Total|Total of all reporting groups
10951109|NCT00811577|FG000|Participant Flow|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
10951110|NCT00811577|FG001|Participant Flow|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
10951111|NCT00811577|OG000|Outcome|PSAS Results for Placebo Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951112|NCT00811577|OG001|Outcome|PSAS Results for 3 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951113|NCT00811577|OG002|Outcome|PSAS Results for 10 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951114|NCT00811577|OG003|Outcome|OSAS Results for Placebo Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951115|NCT00811577|OG004|Outcome|OSAS Results for 3 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951116|NCT00811577|OG005|Outcome|OSAS Results for 10 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951117|NCT00811577|OG000|Outcome|Rater 1 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951118|NCT00811577|OG001|Outcome|Rater 1 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951119|NCT00811577|OG002|Outcome|Rater 1 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951120|NCT00811577|OG003|Outcome|Rater 2 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951121|NCT00811577|OG004|Outcome|Rater 2 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951122|NCT00811577|OG005|Outcome|Rater 2 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951123|NCT00811577|OG000|Outcome|Scar Length for Placebo Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951124|NCT00811577|OG001|Outcome|Scar Length for 3 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951125|NCT00811577|OG002|Outcome|Scar Length for 10 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951126|NCT00811577|OG003|Outcome|Scar Width for Placebo Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951127|NCT00811577|OG004|Outcome|Scar Width for 3 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951128|NCT00811577|OG005|Outcome|Scar Width for 10 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951129|NCT00811577|OG006|Outcome|Scar Minimum Elevation for Placebo Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951130|NCT00811577|OG007|Outcome|Scar Minimum Elevation for 3 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951131|NCT00811577|OG008|Outcome|Scar Minimum Elevation for 10 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951132|NCT00811577|OG009|Outcome|Scar Maximum Elevation for Placebo Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951133|NCT00811577|OG010|Outcome|Scar Maximum Elevation for 3 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951134|NCT00811577|OG011|Outcome|Scar Maximum Elevation for 10 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951135|NCT00811577|OG000|Outcome|Scar Positive Volume for Placebo Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951136|NCT00811577|OG001|Outcome|Scar Positive Volume for 3 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951137|NCT00811577|OG002|Outcome|Scar Positive Volume for 10 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951138|NCT00811577|OG003|Outcome|Scar Negative Volume for Placebo Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951139|NCT00811577|OG004|Outcome|Scar Negative Volume for 3 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951140|NCT00811577|OG005|Outcome|Scar Negative Volume for 10 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951141|NCT00811577|OG006|Outcome|Scar Total Volume for Placebo Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951142|NCT00811577|OG007|Outcome|Scar Total Volume for 3 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951143|NCT00811577|OG008|Outcome|Scar Total Volume for 10 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951144|NCT00811577|OG000|Outcome|Collagen Fiber Density Results for Placebo Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951145|NCT00811577|OG001|Outcome|Collagen Fiber Density Results for 3 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951146|NCT00811577|OG002|Outcome|Collagen Fiber Density Results for 10 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951147|NCT00811577|OG003|Outcome|Collagen Fiber Maturity Results for Placebo Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951148|NCT00811577|OG004|Outcome|Collagen Fiber Maturity Results for 3 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951149|NCT00811577|OG005|Outcome|Collagen Fiber Maturity Results for 10 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951150|NCT00811577|OG006|Outcome|Collagen Fiber Orientation Results for Placebo Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951151|NCT00811577|OG007|Outcome|Collagen Fiber Orientation Results for 3 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951152|NCT00811577|OG008|Outcome|Collagen Fiber Orientation Results for 10 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951153|NCT00811577|OG000|Outcome|Alpha SMA Results for Placebo Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
10951154|NCT00811577|OG001|Outcome|Alpha SMA Results for 3 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
10951155|NCT00811577|OG002|Outcome|Alpha SMA Results for 10 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
10951156|NCT00811577|EG000|Reported Event|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
10951157|NCT00811577|EG001|Reported Event|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
10951158|NCT00811642|BG000|Baseline|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
10951159|NCT00811642|FG000|Participant Flow|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
10951160|NCT00811642|OG000|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
11178355|NCT02046902|FG000|Participant Flow|Pre-Implementation|Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.
11178356|NCT02046902|FG001|Participant Flow|Post-implementation With Decision Coaching|Patients received the consent form, the SDM tool for stent selection, and decision coaching
10951161|NCT00811642|EG000|Reported Event|POSACONAZOLE|400mg oral suspension BID for 12 weeks
10951162|NCT00811655|BG000|Baseline|Pre-OP SRS|"SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
10951163|NCT00811655|FG000|Participant Flow|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
10951164|NCT00811655|OG000|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
10951165|NCT00811655|EG000|Reported Event|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
10951166|NCT00811720|BG000|Baseline|Placebo|as-needed use, tablets, orally, 6 months
10951167|NCT00811720|BG001|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
10951168|NCT00811720|BG002|Baseline|Total|Total of all reporting groups
10951169|NCT00811720|FG000|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
10951170|NCT00811720|FG001|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
10951171|NCT00811720|OG000|Outcome|Placebo|as-needed use, tablets, orally, 6 months
10951172|NCT00811720|OG001|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
10951173|NCT00811720|EG000|Reported Event|Placebo|
10951174|NCT00811720|EG001|Reported Event|Nalmefene 18.06 mg|
10951175|NCT00811733|BG000|Baseline|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
10951176|NCT00811733|BG001|Baseline|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
10951177|NCT00811733|BG002|Baseline|Total|Total of all reporting groups
10951178|NCT00811733|FG000|Participant Flow|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
10951179|NCT00811733|FG001|Participant Flow|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
10951180|NCT00811733|OG000|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
10951181|NCT00811733|OG001|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
10951182|NCT00811733|EG000|Reported Event|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
10951183|NCT00811733|EG001|Reported Event|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
10951184|NCT00811798|BG000|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
10951185|NCT00811798|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
10951186|NCT00811798|OG000|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
10951187|NCT00811798|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
10951188|NCT00811850|BG000|Baseline|All Patients|All patients in the study
10951189|NCT00811850|FG000|Participant Flow|All Patients|This was a cross-over study with 3 treatment periods. In Treatment Period 1, patients received either Combigan® or Cosopt®. In Treatment Period 2, patients were washed out of their previous treatment. In Treatment Period 3, patients received either Combigan® or Cosopt® (treatment not received in Treatment Period 1).
10951190|NCT00811850|OG000|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
10951191|NCT00811850|OG001|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
10951192|NCT00811850|EG000|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
10951193|NCT00811850|EG001|Reported Event|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
11178357|NCT02046902|FG002|Participant Flow|Post-implementation Without Decision Coaching|Patients received the consent form and the SDM tool, but no decision coaching
11178358|NCT02046902|OG000|Outcome|Pre-Implementation|Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.
11178359|NCT02046902|OG001|Outcome|Post-implementation With Decision Coaching|Patients received the consent form, the SDM tool for stent selection, and decision coaching
11178360|NCT02046902|OG002|Outcome|Post-implementation Without Decision Coaching|Patients received the consent form and the SDM tool, but no decision coaching
10951194|NCT00811928|BG000|Baseline|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
10951195|NCT00811928|BG001|Baseline|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
10951196|NCT00811928|BG002|Baseline|Total|Total of all reporting groups
10951197|NCT00811928|FG000|Participant Flow|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
10951198|NCT00811928|FG001|Participant Flow|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
10951199|NCT00811928|OG000|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
10951200|NCT00811928|OG001|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
10951201|NCT00811928|EG000|Reported Event|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
10951202|NCT00811928|EG001|Reported Event|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
10951203|NCT00811941|BG000|Baseline|Placebo|as-needed use, tablets, orally, 52 weeks
10951204|NCT00811941|BG001|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
10951205|NCT00811941|BG002|Baseline|Total|Total of all reporting groups
10951206|NCT00811941|FG000|Participant Flow|Placebo|as-needed use, tablets, orally, 52 weeks
10951207|NCT00811941|FG001|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
10951208|NCT00811941|OG000|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
10951209|NCT00811941|OG001|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
11178361|NCT02046902|EG000|Reported Event|Pre-Implementation|Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.
10951210|NCT00811941|EG000|Reported Event|Placebo|as-needed use, tablets, orally, 52 weeks
11178362|NCT02046902|EG001|Reported Event|Post-implementation With Decision Coaching|Patients received the consent form, the SDM tool for stent selection, and decision coaching
11178363|NCT02046902|EG002|Reported Event|Post-implementation Without Decision Coaching|Patients received the consent form and the SDM tool, but no decision coaching
10951211|NCT00811941|EG001|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
10951212|NCT00811954|BG000|Baseline|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
10951213|NCT00811954|BG001|Baseline|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
10951214|NCT00811954|BG002|Baseline|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
10951215|NCT00811954|BG003|Baseline|Total|Total of all reporting groups
10951216|NCT00811954|FG000|Participant Flow|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
10951217|NCT00811954|FG001|Participant Flow|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
10951218|NCT00811954|FG002|Participant Flow|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
10951219|NCT00811954|OG000|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
10951220|NCT00811954|OG001|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
10951221|NCT00811954|OG002|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
10951222|NCT00811954|EG000|Reported Event|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
10951223|NCT00811954|EG001|Reported Event|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
10951224|NCT00811954|EG002|Reported Event|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
10951225|NCT00812097|BG000|Baseline|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951226|NCT00812097|BG001|Baseline|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951227|NCT00812097|BG002|Baseline|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951228|NCT00812097|BG003|Baseline|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951229|NCT00812097|BG004|Baseline|Total|Total of all reporting groups
10951230|NCT00812097|FG000|Participant Flow|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951231|NCT00812097|FG001|Participant Flow|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951232|NCT00812097|FG002|Participant Flow|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951233|NCT00812097|FG003|Participant Flow|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951234|NCT00812097|OG000|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951235|NCT00812097|OG001|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
11178364|NCT02046941|BG000|Baseline|Speech Production Treatment|"This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity.~Speech Production Treatment: This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction."
10951236|NCT00812097|OG002|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951237|NCT00812097|OG003|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951238|NCT00812097|EG000|Reported Event|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951239|NCT00812097|EG001|Reported Event|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951240|NCT00812097|EG002|Reported Event|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10951241|NCT00812097|EG003|Reported Event|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
10963654|NCT00873093|OG003|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
10963655|NCT00873093|EG000|Reported Event|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963656|NCT00873093|EG001|Reported Event|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
10963657|NCT00873093|EG002|Reported Event|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
11178365|NCT02046941|FG000|Participant Flow|Speech Production Treatment|"This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity.~Speech Production Treatment: This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction."
11192229|NCT02137837|EG001|Reported Event|Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo|"Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Everolimus~Placebo - Anastrozole"
11178366|NCT02046941|OG000|Outcome|Speech Production Treatment|"This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity.~Speech Production Treatment: This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction."
11178367|NCT02046941|EG000|Reported Event|Speech Production Treatment|"This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity.~Speech Production Treatment: This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction."
11192230|NCT02137837|EG002|Reported Event|Arm 3: Fulvestrant + Everolimus + Anastrozole|"Participants receive an injection of fulvestrant in each buttock on Days 1 & 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.~Fulvestrant~Anastrozole~Everolimus"
10951242|NCT00812110|BG000|Baseline|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
10951243|NCT00812110|FG000|Participant Flow|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
10951244|NCT00812110|OG000|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
10951245|NCT00812110|EG000|Reported Event|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
10951246|NCT00812253|BG000|Baseline|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
10951247|NCT00812253|BG001|Baseline|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
10951248|NCT00812253|BG002|Baseline|Total|Total of all reporting groups
10951249|NCT00812253|FG000|Participant Flow|Intravenous Insulin (IV)|Intravenous insulin: In patients assigned to intravenous (IV) insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
10951250|NCT00812253|FG001|Participant Flow|Subcutaneous Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
10951251|NCT00812253|OG000|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
10951252|NCT00812253|OG001|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
10951253|NCT00812253|EG000|Reported Event|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
11192231|NCT02138006|BG000|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
11192232|NCT02138006|BG001|Baseline|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
10951254|NCT00812253|EG001|Reported Event|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
10951255|NCT00812331|BG000|Baseline|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951256|NCT00812331|BG001|Baseline|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951257|NCT00812331|BG002|Baseline|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951258|NCT00812331|BG003|Baseline|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951259|NCT00812331|BG004|Baseline|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951260|NCT00812331|BG005|Baseline|Total|Total of all reporting groups
10951261|NCT00812331|FG000|Participant Flow|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951262|NCT00812331|FG001|Participant Flow|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951263|NCT00812331|FG002|Participant Flow|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951264|NCT00812331|FG003|Participant Flow|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
11178368|NCT02046980|BG000|Baseline|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
10951265|NCT00812331|FG004|Participant Flow|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951266|NCT00812331|OG000|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
10951267|NCT00812331|OG001|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
10951268|NCT00812331|OG002|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
10951269|NCT00812331|OG003|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
10951270|NCT00812331|OG004|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
10951271|NCT00812331|EG000|Reported Event|Total|Participants with chronic genotype 2,3,4,5 or 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
10951272|NCT00812461|BG000|Baseline|Placebo|as-needed use, tablets, orally, 6 months
10951273|NCT00812461|BG001|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
10951274|NCT00812461|BG002|Baseline|Total|Total of all reporting groups
10951275|NCT00812461|FG000|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
10951276|NCT00812461|FG001|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
10951277|NCT00812461|OG000|Outcome|Placebo|as-needed use, tablets, orally, 6 months
11178369|NCT02046980|BG001|Baseline|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
11178370|NCT02046980|BG002|Baseline|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
10951278|NCT00812461|OG001|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
10951279|NCT00812461|EG000|Reported Event|Placebo|as-needed use, tablets, orally, 6 months
10951280|NCT00812461|EG001|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
10951281|NCT00812487|BG000|Baseline|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
10951282|NCT00812487|BG001|Baseline|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
10951283|NCT00812487|BG002|Baseline|Total|Total of all reporting groups
10951284|NCT00812487|FG000|Participant Flow|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
10951285|NCT00812487|FG001|Participant Flow|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
10951286|NCT00812487|OG000|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
10951287|NCT00812487|OG001|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
10951288|NCT00812487|EG000|Reported Event|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
10951289|NCT00812487|EG001|Reported Event|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
11178371|NCT02046980|BG003|Baseline|Total|Total of all reporting groups
11178372|NCT02046980|FG000|Participant Flow|Gufoni|"Gufoni maneuver for apogeotropic horizontal benign paroxysmal positional vertigo (BPPV) at the first day~Gufoni"
11178373|NCT02046980|FG001|Participant Flow|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
11178374|NCT02046980|FG002|Participant Flow|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
11178375|NCT02046980|OG000|Outcome|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
10951290|NCT00812565|BG000|Baseline|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
10951291|NCT00812565|BG001|Baseline|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
10951292|NCT00812565|BG002|Baseline|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
10951293|NCT00812565|BG003|Baseline|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
10951294|NCT00812565|BG004|Baseline|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
10951295|NCT00812565|BG005|Baseline|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
10951296|NCT00812565|BG006|Baseline|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
10951297|NCT00812565|BG007|Baseline|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
10951298|NCT00812565|BG008|Baseline|Total|Total of all reporting groups
10951299|NCT00812565|FG000|Participant Flow|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
10951300|NCT00812565|FG001|Participant Flow|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
10951301|NCT00812565|FG002|Participant Flow|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
10951302|NCT00812565|FG003|Participant Flow|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
11178376|NCT02046980|OG001|Outcome|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
11178377|NCT02046980|OG002|Outcome|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
10951303|NCT00812565|FG004|Participant Flow|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
10951304|NCT00812565|FG005|Participant Flow|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
10951305|NCT00812565|FG006|Participant Flow|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
10951306|NCT00812565|FG007|Participant Flow|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
10951307|NCT00812565|OG000|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
10951308|NCT00812565|OG001|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
10951309|NCT00812565|OG002|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
10951310|NCT00812565|OG003|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
10951311|NCT00812565|OG004|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
10951312|NCT00812565|OG005|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
10951313|NCT00812565|OG006|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
10951314|NCT00812565|OG007|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
10951315|NCT00812565|EG000|Reported Event|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
10951316|NCT00812565|EG001|Reported Event|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
10951317|NCT00812565|EG002|Reported Event|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
10951318|NCT00812565|EG003|Reported Event|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
10951319|NCT00812565|EG004|Reported Event|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
10951320|NCT00812565|EG005|Reported Event|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
10951321|NCT00812565|EG006|Reported Event|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
10951322|NCT00812565|EG007|Reported Event|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
10951323|NCT00812604|BG000|Baseline|Ping On Ointment Group|Ping On Ointment was used
10951324|NCT00812604|BG001|Baseline|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
10951325|NCT00812604|BG002|Baseline|Total|Total of all reporting groups
10951326|NCT00812604|FG000|Participant Flow|Ping On Ointment Group|Ping On Ointment was used
10951327|NCT00812604|FG001|Participant Flow|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
11178378|NCT02046980|EG000|Reported Event|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
11178379|NCT02046980|EG001|Reported Event|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
11178380|NCT02046980|EG002|Reported Event|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
11192233|NCT02138006|BG002|Baseline|Total|Total of all reporting groups
11192234|NCT02138006|FG000|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
10951328|NCT00812604|OG000|Outcome|Ping On Ointment Group|Ping On Ointment was used
10951329|NCT00812604|OG001|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
10951330|NCT00812604|EG000|Reported Event|Ping On Ointment Group|Ping On Ointment was used
10951331|NCT00812604|EG001|Reported Event|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
10951332|NCT00812812|BG000|Baseline|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
10951333|NCT00812812|BG001|Baseline|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
10951334|NCT00812812|BG002|Baseline|Total|Total of all reporting groups
11178381|NCT02046993|BG000|Baseline|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
10951335|NCT00812812|FG000|Participant Flow|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
10951336|NCT00812812|FG001|Participant Flow|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
10951337|NCT00812812|OG000|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
10951338|NCT00812812|OG001|Outcome|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
10951339|NCT00812812|OG001|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
10951340|NCT00812812|OG000|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
10951341|NCT00812812|EG000|Reported Event|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
10951342|NCT00812812|EG001|Reported Event|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
10951343|NCT00812838|BG000|Baseline|Experimental|"100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline~*Crossover subjects were added to Experimental Group for analysis*"
10951344|NCT00812838|BG001|Baseline|Placebo Comparator|"Normal saline Injection solution will consist of 10 cc preservative free normal saline.~Optional Cross-over: For subjects in Arm 2, crossover to BOTOX treatment will begin after the Week 16 Visit by repeating the study schedule as for Week 0 to Week 16."
10951345|NCT00812838|BG002|Baseline|Total|Total of all reporting groups
10951346|NCT00812838|FG000|Participant Flow|Experimental|100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
10951347|NCT00812838|FG001|Participant Flow|Placebo Comparator|"Normal saline Injection solution will consist of 10 cc preservative free normal saline.~Optional Cross-over: For subjects in Arm 2, crossover to BOTOX treatment will begin after the Week 16 Visit by repeating the study schedule as for Week 0 to Week 16."
10951348|NCT00812838|OG000|Outcome|Experimental|100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
10951349|NCT00812838|OG001|Outcome|Placebo Comparator|Normal saline Injection solution will consist of 10 cc preservative free normal saline
10951350|NCT00812838|OG000|Outcome|100 Units of Botulinum Toxin Type A|"Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline~100 units of Botulinum Toxin Type A: Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque"
11192235|NCT02138006|FG001|Participant Flow|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
10951351|NCT00812838|OG001|Outcome|Normal Saline|"Injection solution will consist of 10 cc preservative free normal saline~Preservative free normal saline: Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque"
10951352|NCT00812838|EG000|Reported Event|100 Units of Botulinum Toxin Type A|"Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline~100 units of Botulinum Toxin Type A: Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque"
10951353|NCT00812838|EG001|Reported Event|Normal Saline|"Injection solution will consist of 10 cc preservative free normal saline~Preservative free normal saline: Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque"
10951354|NCT00812877|BG000|Baseline|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
10951355|NCT00812877|BG001|Baseline|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
10951356|NCT00812877|BG002|Baseline|Total|Total of all reporting groups
10951357|NCT00812877|FG000|Participant Flow|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
10951358|NCT00812877|FG001|Participant Flow|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
10951359|NCT00812877|OG000|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
11178382|NCT02046993|BG001|Baseline|Hypertensive Patients on Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
11178383|NCT02046993|BG002|Baseline|Total|Total of all reporting groups
11178384|NCT02046993|FG000|Participant Flow|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
10951360|NCT00812877|OG001|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
10951361|NCT00812877|EG000|Reported Event|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
10951362|NCT00812877|EG001|Reported Event|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
10951363|NCT00812916|BG000|Baseline|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
10951364|NCT00812916|FG000|Participant Flow|Number of Patients|Radiofrequency (RF) Ablation using specialized complex fractionated atrial electrogram (CFAE) software
10951365|NCT00812916|OG000|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
10951366|NCT00812916|OG000|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
10951367|NCT00812916|OG000|Outcome|RF Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
10951368|NCT00812916|EG000|Reported Event|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
10951369|NCT00812929|BG000|Baseline|Total|Eligible participants completed five treatment periods (single dose 10 mg, 50 mg, 100 mg, 200 mg GSK2190915 oral solution, compared to placebo control which was administered on Day 1 of each treatment period). Each treatment period lasted 2 days, with a minimum 7 day washout period between each treatment periods.
10951370|NCT00812929|FG000|Participant Flow|P/A/D/B/C|In this sequence participants received treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 1, treatment A of oral single dose of aqueous solution of 10 milligrams (mg) GSK2190915 on Day 1 of treatment period 2, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 3, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 4 and treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951371|NCT00812929|FG001|Participant Flow|A/B/P/C/D|In this sequence participants received treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 1, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 2, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 3, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 4 and treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10963658|NCT00873093|EG003|Reported Event|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
11178385|NCT02046993|FG001|Participant Flow|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
11178386|NCT02046993|OG000|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
11192236|NCT02138006|OG000|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
10951372|NCT00812929|FG002|Participant Flow|B/C/A/D/P|In this sequence participants received treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 1, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 2, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 3, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 4, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951373|NCT00812929|FG003|Participant Flow|C/D/B/P/A|In this sequence participants received treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 1, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 2, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 3, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 4, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951374|NCT00812929|FG004|Participant Flow|D/P/C/A/B|In this sequence participants received treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 1, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 2, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 3, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 4, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951375|NCT00812929|FG005|Participant Flow|C/B/D/A/P|In this sequence participants received treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 1, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 2, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 3, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 4, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951376|NCT00812929|FG006|Participant Flow|D/C/P/B/A|In this sequence participants received treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 1, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 2, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 3, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 4, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951377|NCT00812929|FG007|Participant Flow|P/D/A/C/B|In this sequence participants received treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 1, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 2, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 3, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 4, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951378|NCT00812929|FG008|Participant Flow|A/P/B/D/C|In this sequence participants received treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 1, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 2, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 3, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 4, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951379|NCT00812929|FG009|Participant Flow|B/A/C/P/D|In this sequence participants received treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 1, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 2, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 3, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 4, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
10951380|NCT00812929|OG000|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 milliliter (mL) of water on Day 1 of each treatment period.
10951381|NCT00812929|OG001|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951382|NCT00812929|OG002|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951383|NCT00812929|OG003|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951384|NCT00812929|OG004|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951385|NCT00812929|OG000|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951386|NCT00812929|OG000|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951387|NCT00812929|OG001|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951388|NCT00812929|OG002|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951389|NCT00812929|OG003|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
10951390|NCT00812929|EG000|Reported Event|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
10951391|NCT00812929|EG001|Reported Event|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
10951392|NCT00812929|EG002|Reported Event|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
10951393|NCT00812929|EG003|Reported Event|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
10951394|NCT00812929|EG004|Reported Event|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
10951395|NCT00812955|BG000|Baseline|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
10951396|NCT00812955|BG001|Baseline|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
11178387|NCT02046993|OG001|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
11178388|NCT02046993|OG000|Outcome|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
11178389|NCT02046993|OG001|Outcome|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
10951397|NCT00812955|BG002|Baseline|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
10951398|NCT00812955|BG003|Baseline|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
10951399|NCT00812955|BG004|Baseline|Total|Total of all reporting groups
10951400|NCT00812955|FG000|Participant Flow|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
10951401|NCT00812955|FG001|Participant Flow|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
10951402|NCT00812955|FG002|Participant Flow|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
10951403|NCT00812955|FG003|Participant Flow|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
10951404|NCT00812955|OG000|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
10951405|NCT00812955|OG001|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg
10951406|NCT00812955|OG001|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg
10951407|NCT00812955|OG001|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg
10951408|NCT00812955|OG000|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
10951409|NCT00812955|OG001|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
10951410|NCT00812955|OG002|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
10951411|NCT00812955|OG003|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
10951412|NCT00812955|EG000|Reported Event|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
10951413|NCT00812955|EG001|Reported Event|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
10951414|NCT00812955|EG002|Reported Event|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
10951415|NCT00812955|EG003|Reported Event|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
10951416|NCT00812968|BG000|Baseline|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
10951417|NCT00812968|FG000|Participant Flow|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle. Treatment continued until disease progression or relapse following an erythroid improvement was documented, any of the criteria for treatment discontinuation was violated, or lenalidomide became commercially available for the treatment of MDS associated with a del (5q) cytogenetic abnormality, for up to 156 weeks (3 years).
10951418|NCT00812968|OG000|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
10951419|NCT00812968|OG000|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
11192237|NCT02138006|OG001|Outcome|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
10951420|NCT00812968|OG001|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
10951421|NCT00812968|EG000|Reported Event|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
10951422|NCT00812981|BG000|Baseline|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
10951423|NCT00812981|BG001|Baseline|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
10951424|NCT00812981|BG002|Baseline|Total|Total of all reporting groups
10951425|NCT00812981|FG000|Participant Flow|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
10951426|NCT00812981|FG001|Participant Flow|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
10951427|NCT00812981|OG000|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
10951428|NCT00812981|OG001|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
10951429|NCT00812981|EG000|Reported Event|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
10951430|NCT00812981|EG001|Reported Event|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
11178390|NCT02046993|EG000|Reported Event|Smart Phone Based Telemonitoring of HBP|". Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP + enhanced usual care: Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary"
11178391|NCT02046993|EG001|Reported Event|Enhanced Usual Care|". Patients to do HBP measurement~. Record BP readings in their diary~Enhanced usual care: Encouraged to do HBP measurement and record BP readings in paper diary"
11178392|NCT02047032|BG000|Baseline|Acupuncture|"BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).~acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand."
10951431|NCT00813098|BG000|Baseline|High Dose|A high dose of LX1031; daily oral intake for 28 days
11192238|NCT02138006|EG000|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
11192239|NCT02138006|EG001|Reported Event|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
11192240|NCT02138097|BG000|Baseline|UHC: Glitazones|Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication.
10951432|NCT00813098|BG001|Baseline|Low Dose|A low dose of LX1031; daily oral intake for 28 days
10951433|NCT00813098|BG002|Baseline|Placebo|Matching placebo dosing with daily oral intake
10951434|NCT00813098|BG003|Baseline|Total|Total of all reporting groups
10951435|NCT00813098|FG000|Participant Flow|High Dose|A high dose of LX1031; daily oral intake for 28 days
10951436|NCT00813098|FG001|Participant Flow|Low Dose|A low dose of LX1031; daily oral intake for 28 days
10951437|NCT00813098|FG002|Participant Flow|Placebo|Matching placebo dosing with daily oral intake
10951438|NCT00813098|OG000|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
10951439|NCT00813098|OG001|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
10951440|NCT00813098|OG002|Outcome|Placebo|Matching placebo dosing with daily oral intake
10951441|NCT00813098|EG000|Reported Event|High Dose|A high dose of LX1031; daily oral intake for 28 days
10951442|NCT00813098|EG001|Reported Event|Low Dose|A low dose of LX1031; daily oral intake for 28 days
10951443|NCT00813098|EG002|Reported Event|Placebo|Matching placebo dosing with daily oral intake
10951444|NCT00813111|BG000|Baseline|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
10951445|NCT00813111|BG001|Baseline|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
10951446|NCT00813111|BG002|Baseline|Total|Total of all reporting groups
10951447|NCT00813111|FG000|Participant Flow|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
10951448|NCT00813111|FG001|Participant Flow|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
10951449|NCT00813111|OG000|Outcome|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
10951450|NCT00813111|OG001|Outcome|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
10951451|NCT00813111|EG000|Reported Event|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
10951452|NCT00813111|EG001|Reported Event|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
10951453|NCT00813124|BG000|Baseline|Azacytidine Maintenance After Allotx|Fludarabine 40 mg/m^2 intravenous (IV) Day -5 to Day -2; Busulfan dose calculated to achieve area under curve (AUC) of 4000 µMol-min + 12% based on pharmacokinetic studies (days -5, -4, -3, and -2); Thymoglobulin: 2.5 mg/kg IV on Day -3 to Day -1; Azacitidine 32 mg/m^2 subcutaneous daily for 5 days starting 5 weeks after transplant, repeated monthly up to 4 months. Allogeneic stem cell infusion (allotx) on day 0.
10951454|NCT00813124|FG000|Participant Flow|Azacitidine Post Transplant|Fludarabine 40 mg/m^2 intravenous (IV) Day -5 to Day -2; Busulfan dose calculated to achieve area under curve (AUC) of 4000 µMol-min + 12% based on pharmacokinetic studies (days -5, -4, -3, and -2); Thymoglobulin: 2.5 mg/kg IV on Day -3 to Day -1; Azacitidine 32 mg/m^2 subcutaneous daily for 5 days starting 5 weeks after transplant, repeated monthly up to 4 months. Allogeneic stem cell infusion (allotx) on day 0.
10951455|NCT00813124|OG000|Outcome|Azacytidine Maintenance After Allotx|Fludarabine 40 mg/m^2 intravenous (IV) Day -5 to Day -2; Busulfan dose calculated to achieve area under curve (AUC) of 4000 µMol-min + 12% based on pharmacokinetic studies (days -5, -4, -3, and -2); Thymoglobulin: 2.5 mg/kg IV on Day -3 to Day -1; Azacitidine 32 mg/m^2 subcutaneous daily for 5 days starting 5 weeks after transplant, repeated monthly up to 4 months. Allogeneic stem cell infusion (allotx) on day 0.
10951456|NCT00813124|EG000|Reported Event|Azacytidine Maintenance After Allotx|Fludarabine 40 mg/m^2 intravenous (IV) Day -5 to Day -2; Busulfan dose calculated to achieve area under curve (AUC) of 4000 µMol-min + 12% based on pharmacokinetic studies (days -5, -4, -3, and -2); Thymoglobulin: 2.5 mg/kg IV on Day -3 to Day -1; Azacitidine 32 mg/m^2 subcutaneous daily for 5 days starting 5 weeks after transplant, repeated monthly up to 4 months. Allogeneic stem cell infusion (allotx) on day 0.
10951457|NCT00813150|BG000|Baseline|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
11178393|NCT02047032|BG001|Baseline|Solifenacin Plus PFMT|"Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.~solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )~PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE)."
11178394|NCT02047032|BG002|Baseline|Total|Total of all reporting groups
11178395|NCT02047032|FG000|Participant Flow|Acupuncture|"BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).~acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand."
11192241|NCT02138097|BG001|Baseline|UHC: Linagliptin|Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
11192242|NCT02138097|BG002|Baseline|UHC: Meglitinides|Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
10951458|NCT00813150|BG001|Baseline|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
10951459|NCT00813150|BG002|Baseline|Total|Total of all reporting groups
10951460|NCT00813150|FG000|Participant Flow|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
10951461|NCT00813150|FG001|Participant Flow|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
10951462|NCT00813150|OG000|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
10951463|NCT00813150|OG001|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
10951464|NCT00813150|EG000|Reported Event|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
10951465|NCT00813150|EG001|Reported Event|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
10951466|NCT00813176|BG000|Baseline|Double Lumen Endotracheal Tube|Double Lumen Endotracheal Tube Device where lung collapse can be achieved by clamping one of the lumens (the operated lung) 25 subjects were enrolled in this group
10951467|NCT00813176|BG001|Baseline|Arndt Bronchial Blocker|Arndt Bronchial Blocker in conjunction with a single lumen endotracheal tube. Device that allows collapse of one lung (the operated lung). 25 subjects were enrolled in this group
10951468|NCT00813176|BG002|Baseline|Total|Total of all reporting groups
10951469|NCT00813176|FG000|Participant Flow|Double Lumen Endotracheal Tube|"Double Lumen Endotracheal Tube This group was one arm of this research to determine the advantages of this group versus a comparative bronchial blocker group.~We assessed 56 subjects and enrolled 50. A total of 6 were excluded because they did not meet criteria (4) or refused to participate (2)."
10951470|NCT00813176|FG001|Participant Flow|Arndt Bronchial Blocker|Arndt Bronchial Blocker We assessed 56 subjects and enrolled 50. A total of 6 were excluded because they did not meet criteria (4) or refused to participate (2).
10951471|NCT00813176|OG000|Outcome|Double Lumen Endotracheal Tube|Left-sided double lumen endotracheal tube Broncho-Cath®
10951472|NCT00813176|OG001|Outcome|Arndt Bronchial Blocker|Arndt® blocker group: Intubation with a standard single-lumen tracheal tube (8.0-9.0 mm ID) followed by the passage of a 9 Fr Arndt® spherical blocker
10951473|NCT00813176|OG000|Outcome|Double Lumen Endotracheal Tube|Double Lumen Endotracheal Tube
11178396|NCT02047032|FG001|Participant Flow|Solifenacin Plus PFMT|"Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.~solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )~PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE)."
11178397|NCT02047032|OG000|Outcome|Solifenacin Plus PFMT|"Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.~solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )~PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE)."
10951474|NCT00813176|OG001|Outcome|Arndt Bronchial Blocker|Arndt Bronchial Blocker
10951475|NCT00813176|EG000|Reported Event|Double Lumen Endotracheal Tube|Left-sided double lumen endotracheal tube Broncho-Cath®
10951476|NCT00813176|EG001|Reported Event|Arndt Bronchial Blocker|Arndt® blocker group: Intubation with a standard single-lumen tracheal tube (8.0-9.0 mm ID) followed by the passage of a 9 Fr Arndt® spherical blocker.
10951477|NCT00813293|BG000|Baseline|Sorafenib|Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).
10951478|NCT00813293|BG001|Baseline|Placebo|Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).
10951479|NCT00813293|BG002|Baseline|Total|Total of all reporting groups
10951480|NCT00813293|FG000|Participant Flow|Sorafenib|Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).
10951481|NCT00813293|FG001|Participant Flow|Placebo|Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).
10951482|NCT00813293|OG000|Outcome|Sorafenib|Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).
10951483|NCT00813293|OG001|Outcome|Placebo|Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).
10951484|NCT00813293|EG000|Reported Event|Sorafenib|"Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).~Sorafenib~radiofrequency ablation"
10951485|NCT00813293|EG001|Reported Event|Placebo|"Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).~radiofrequency ablation"
10951486|NCT00813319|BG000|Baseline|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
10951487|NCT00813319|BG001|Baseline|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
10951488|NCT00813319|BG002|Baseline|Total|Total of all reporting groups
10951489|NCT00813319|FG000|Participant Flow|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
10951490|NCT00813319|FG001|Participant Flow|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
10951491|NCT00813319|OG000|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
10951492|NCT00813319|OG001|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
10951493|NCT00813319|EG000|Reported Event|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
10951494|NCT00813319|EG001|Reported Event|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
10951495|NCT00813358|BG000|Baseline|Endovascular Repair|"treatment~Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device"
10951496|NCT00813358|FG000|Participant Flow|Endovascular Repair|Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device
10951497|NCT00813358|OG000|Outcome|Endovascular Repair|Zenith® TX2® TAA Endovascular Graft through 5 years.
10951498|NCT00813358|EG000|Reported Event|Endovascular Repair|"treatment~Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device"
10951499|NCT00813488|BG000|Baseline|Total Number of Patients|
10951500|NCT00813488|FG000|Participant Flow|FBT First Immediate Release Oxycodone Second|Subjects in this treatment group were assigned 200 mcg FBT during the first titration period and then 15 mg oxycodone during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
10951501|NCT00813488|FG001|Participant Flow|Immediate-Release Oxycodone First FBT Second|Subjects in this treatment group were assigned 15 mg oxycodone during the first titration period and then 200 mcg FBT during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
11178398|NCT02047032|OG001|Outcome|Electroacupuncture|"BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).~acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand."
11192243|NCT02138097|BG003|Baseline|UHC: Metformin|Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
10951502|NCT00813488|OG000|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
10951503|NCT00813488|OG001|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
10951504|NCT00813488|OG000|Outcome|Total|"Includes all patients who participated in the double-blind treatment period and completed treatment.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
10951505|NCT00813488|OG000|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
10951506|NCT00813488|OG001|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
10951507|NCT00813488|EG000|Reported Event|Fentanyl Buccal Tablet|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period. 213 subjects began the first titration period and of those 17 discontinued before exposure to FBT. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 196 subjects had exposure to FBT
10951508|NCT00813488|EG001|Reported Event|Oxycodone|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period (they were only exposed to one drug). 213 subjects began the first titration period and of those 27 discontinued before exposure to oxycodone. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 186 subjects had exposure to oxycodone
10951509|NCT00813488|EG002|Reported Event|Standard of Care|21 subjects received standard of care analgesics apart from oxycodone or FBT during the Open-Label Extension Period. Subjects who took oxycodone during SOC are listed under Oxycodone.
10951510|NCT00813592|BG000|Baseline|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
10951511|NCT00813592|FG000|Participant Flow|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
10951512|NCT00813592|OG000|Outcome|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
11192244|NCT02138097|BG004|Baseline|UHC: Saxagliptin|Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
11192245|NCT02138097|BG005|Baseline|UHC: Sitagliptin|Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
11192246|NCT02138097|BG006|Baseline|UHC: Sulfonylurea|Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
11192247|NCT02138097|BG007|Baseline|UHC: Alpha-Glucosidase Inhibitors|Patients in the United Healthcare cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
10951513|NCT00813592|OG000|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
10951514|NCT00813592|EG000|Reported Event|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
10951515|NCT00813709|BG000|Baseline|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (9 participants from DB converted to CDMS and switched to OL period over course of this study)
10951516|NCT00813709|BG001|Baseline|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (26 participants from DB converted to CDMS and switched to OL period over course of this study)
10951517|NCT00813709|BG002|Baseline|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (18 participants from DB converted to CDMS and switched to OL period over course of this study)
10951518|NCT00813709|BG003|Baseline|Total|Total of all reporting groups
10951519|NCT00813709|FG000|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10951520|NCT00813709|FG001|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
10951521|NCT00813709|FG002|Participant Flow|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
10963659|NCT00873093|EG004|Reported Event|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
11178399|NCT02047032|OG000|Outcome|Electroacupuncture|"BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).~acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand."
11192248|NCT02138097|BG008|Baseline|UHC: GLP-I RA|Patients in the United Healthcare cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
10951522|NCT00813709|FG003|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
10951523|NCT00813709|FG004|Participant Flow|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
10951524|NCT00813709|FG005|Participant Flow|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
10951525|NCT00813709|OG000|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
10951526|NCT00813709|OG001|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
10951527|NCT00813709|OG002|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
10951528|NCT00813709|OG000|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10951529|NCT00813709|OG001|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
10951530|NCT00813709|OG002|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
10951531|NCT00813709|OG000|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10951532|NCT00813709|OG001|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
10951533|NCT00813709|OG002|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
11178400|NCT02047032|OG001|Outcome|Solifenacin Plus PFMT|"Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.~solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )~PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE)."
10951534|NCT00813709|OG000|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
10951535|NCT00813709|OG001|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
10951536|NCT00813709|OG002|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
10951537|NCT00813709|OG000|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
10951538|NCT00813709|OG001|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
10951539|NCT00813709|OG002|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
10951540|NCT00813709|OG000|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10951541|NCT00813709|OG001|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
10951542|NCT00813709|OG002|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
10951543|NCT00813709|OG000|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10951544|NCT00813709|OG001|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
11192249|NCT02138097|BG009|Baseline|MS: Linagliptin|Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
10951545|NCT00813709|OG002|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
10951546|NCT00813709|EG000|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
10951547|NCT00813709|EG001|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
10951548|NCT00813709|EG002|Reported Event|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
10951549|NCT00813709|EG003|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
10951550|NCT00813709|EG004|Reported Event|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
10951551|NCT00813709|EG005|Reported Event|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
10951552|NCT00813748|BG000|Baseline|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
10951553|NCT00813748|BG001|Baseline|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant's anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
10951554|NCT00813748|BG002|Baseline|Total|Total of all reporting groups
10951555|NCT00813748|FG000|Participant Flow|Omalizumab Cases|Participants who received omalizumab (Xolair) and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
11192250|NCT02138097|BG010|Baseline|MS: Sitagliptin|Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
10951556|NCT00813748|FG001|Participant Flow|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant's anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
10951557|NCT00813748|OG000|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
10951558|NCT00813748|OG001|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant's anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
10951559|NCT00813748|EG000|Reported Event|Observational Study: Omalizumab Cases - With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
10951560|NCT00813748|EG001|Reported Event|Observational Study: Omalizumab Controls - Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant's anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
10951561|NCT00813748|EG002|Reported Event|Skin Test Substudy: Omalizumab Cases - With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
11192251|NCT02138097|BG011|Baseline|MS: Saxagliptin|Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
11192252|NCT02138097|BG012|Baseline|MS: Metformin|Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
10951562|NCT00813748|EG003|Reported Event|Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant's anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
10951563|NCT00813761|BG000|Baseline|Clear Care LCS|Subjects assigned to Clear Care lens care solution
10951564|NCT00813761|BG001|Baseline|ReNU MPS|Subjects assigned to ReNU multi purpose solution
10951565|NCT00813761|BG002|Baseline|Total|Total of all reporting groups
10951566|NCT00813761|FG000|Participant Flow|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
10951567|NCT00813761|FG001|Participant Flow|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
10951568|NCT00813761|FG002|Participant Flow|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
10951569|NCT00813761|FG003|Participant Flow|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
10951570|NCT00813761|OG000|Outcome|Clear Care Lens Cleaning Solution (LCS)|All subjects assigned to Clear Care LCS
11178401|NCT02047032|EG000|Reported Event|Electroacupuncture|"BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).~acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand."
11192253|NCT02138097|BG013|Baseline|MS: Sulfonylurea|Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
10951571|NCT00813761|OG001|Outcome|ReNU Multi Purpose Solution (MPS)|All subjects assigned to ReNU MPS
10951572|NCT00813761|OG000|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
10951573|NCT00813761|OG001|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
10951574|NCT00813761|OG000|Outcome|Clear Care LCS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
10951575|NCT00813761|OG001|Outcome|ReNU MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
10951576|NCT00813761|OG000|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
10951577|NCT00813761|OG001|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
10951578|NCT00813761|OG002|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
10951579|NCT00813761|OG003|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
10951580|NCT00813761|EG000|Reported Event|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
10951581|NCT00813761|EG001|Reported Event|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose
10951582|NCT00813761|EG002|Reported Event|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
10951583|NCT00813761|EG003|Reported Event|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
10951584|NCT00813800|BG000|Baseline|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
10951585|NCT00813800|FG000|Participant Flow|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
10951586|NCT00813800|OG000|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
10951587|NCT00813800|EG000|Reported Event|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
10951588|NCT00813813|BG000|Baseline|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
10951589|NCT00813813|BG001|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
10951590|NCT00813813|BG002|Baseline|Total|Total of all reporting groups
10951591|NCT00813813|FG000|Participant Flow|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
10951592|NCT00813813|FG001|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
10951593|NCT00813813|OG000|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
10951594|NCT00813813|OG001|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
10951595|NCT00813813|EG000|Reported Event|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
10951596|NCT00813813|EG001|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
10951597|NCT00813865|BG000|Baseline|Afegostat Tartrate|Afegostat tartrate was administered orally at a dose of 225 mg QD MWF 3-days-on/4-days-off. Participants were to receive afegostat tartrate for 30 months and be followed for 6 months after EOT.
10951598|NCT00813865|FG000|Participant Flow|Afegostat Tartrate|Afegostat tartrate was administered orally at a dose of 225 milligram (mg) once daily (QD) on Monday, Wednesday, and Friday, with no study medication on Tuesday, Thursday, Saturday, and Sunday (MWF 3-days-on/4-days-off). Participants were to receive afegostat tartrate for 30 months and be followed for 6 months after the end of treatment (EOT).
10951599|NCT00813865|OG000|Outcome|Afegostat Tartrate|Afegostat tartrate was administered orally at a dose of 225 mg QD MWF 3-days-on/4-days-off. Participants were to receive afegostat tartrate for 30 months and be followed for 6 months after EOT.
10951600|NCT00813865|EG000|Reported Event|Afegostat Tartrate|Afegostat tartrate was administered orally at a dose of 225 mg QD MWF 3-days-on/4-days-off. Participants were to receive afegostat tartrate for 30 months and be followed for 6 months after EOT.
10951601|NCT00813904|BG000|Baseline|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
10951602|NCT00813904|FG000|Participant Flow|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
10951603|NCT00813904|OG000|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
10951604|NCT00813904|EG000|Reported Event|TOTAL|
10951605|NCT00813917|BG000|Baseline|Varenicline|varenicline-1mg/day for 12 weeks
10951606|NCT00813917|BG001|Baseline|Placebo|nonactive lookalike pill per day for 12 weeks
10951607|NCT00813917|BG002|Baseline|Total|Total of all reporting groups
10951608|NCT00813917|FG000|Participant Flow|Varenicline|varenicline-1mg/day for 12 weeks
10951609|NCT00813917|FG001|Participant Flow|Placebo|nonactive lookalike pill per day for 12 weeks
10951610|NCT00813917|OG000|Outcome|Varenicline|varenicline-1mg/day for 12 weeks
11192254|NCT02138097|BG014|Baseline|MS: Glitazones|Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication.
10951611|NCT00813917|OG001|Outcome|Placebo|nonactive lookalike pill per day for 12 weeks
10951612|NCT00813917|EG000|Reported Event|Varenicline|varenicline-1mg/day for 12 weeks
10951613|NCT00813917|EG001|Reported Event|Placebo|nonactive lookalike pill per day for 12 weeks
10951614|NCT00813943|BG000|Baseline|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951615|NCT00813943|BG001|Baseline|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951616|NCT00813943|BG002|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
10951617|NCT00813943|BG003|Baseline|Total|Total of all reporting groups
10951618|NCT00813943|FG000|Participant Flow|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951619|NCT00813943|FG001|Participant Flow|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951620|NCT00813943|FG002|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
10951621|NCT00813943|OG000|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951622|NCT00813943|OG001|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951623|NCT00813943|OG002|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
10951624|NCT00813943|OG000|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951625|NCT00813943|EG000|Reported Event|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951626|NCT00813943|EG001|Reported Event|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
10951627|NCT00813943|EG002|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
10951628|NCT00813982|BG000|Baseline|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
11192255|NCT02138097|BG015|Baseline|MS: Meglitinides|Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
11192256|NCT02138097|BG016|Baseline|MS: Alpha-Glucosidase Inhibitors|Patients in the MarketScan (MS) cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
10951629|NCT00813982|FG000|Participant Flow|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
10951630|NCT00813982|OG000|Outcome|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
10951631|NCT00813982|OG001|Outcome|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
10951632|NCT00813982|EG000|Reported Event|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens
10951633|NCT00813982|EG001|Reported Event|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens
10951634|NCT00813995|BG000|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
10951635|NCT00813995|BG001|Baseline|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
10951636|NCT00813995|BG002|Baseline|Total|Total of all reporting groups
10951637|NCT00813995|FG000|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
10951638|NCT00813995|FG001|Participant Flow|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
10951639|NCT00813995|OG000|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
10951640|NCT00813995|OG001|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
10951641|NCT00813995|OG000|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
10951642|NCT00813995|OG001|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
10951643|NCT00813995|OG000|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
10951644|NCT00813995|OG001|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
10951645|NCT00813995|EG000|Reported Event|Sitagliptin|
11192257|NCT02138097|BG017|Baseline|MS: GLP-I RA|Patients in the MarketScan (MS) cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
10951646|NCT00813995|EG001|Reported Event|Placebo|
10951647|NCT00814138|BG000|Baseline|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
10951648|NCT00814138|BG001|Baseline|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
10951649|NCT00814138|BG002|Baseline|Total|Total of all reporting groups
10951650|NCT00814138|FG000|Participant Flow|1 - Methotrexate (2.5 mg)|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
10951651|NCT00814138|FG001|Participant Flow|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
10951652|NCT00814138|OG000|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
10951653|NCT00814138|OG001|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
10951654|NCT00814138|OG000|Outcome|Methotrexate|Methotrexate: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
10951655|NCT00814138|OG001|Outcome|Placebo|Placebo: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
10951656|NCT00814138|EG000|Reported Event|Methotrexate Group - Adverse Events|Reported the number of adverse events in the group randomized to methotrexate.
10951657|NCT00814138|EG001|Reported Event|Placebo Group - Adverse Events|Reported the number of adverse events in the group randomized to placebo
10951658|NCT00814164|BG000|Baseline|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
10951659|NCT00814164|FG000|Participant Flow|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
10951660|NCT00814164|OG000|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
10951661|NCT00814164|EG000|Reported Event|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
10951662|NCT00814177|BG000|Baseline|No Change|Intervention Drug warfarin no change in the dose is performed
10951663|NCT00814177|BG001|Baseline|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
10951664|NCT00814177|BG002|Baseline|Total|Total of all reporting groups
10951665|NCT00814177|FG000|Participant Flow|No Change|Intervention Drug warfarin no change in the dose is performed
10951666|NCT00814177|FG001|Participant Flow|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
11192258|NCT02138097|BG018|Baseline|Total|Total of all reporting groups
10951667|NCT00814177|OG000|Outcome|No Change|Intervention Drug warfarin no change in the dose is performed
10951668|NCT00814177|OG001|Outcome|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
10951669|NCT00814177|EG000|Reported Event|No Change|Intervention Drug warfarin no change in the dose is performed
10951670|NCT00814177|EG001|Reported Event|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
10951671|NCT00814255|BG000|Baseline|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
10951672|NCT00814255|BG001|Baseline|Conservative Medical Therapy|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
10951673|NCT00814255|BG002|Baseline|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
10951674|NCT00814255|BG003|Baseline|Total|Total of all reporting groups
10951675|NCT00814255|FG000|Participant Flow|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
10951676|NCT00814255|FG001|Participant Flow|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
10951677|NCT00814255|FG002|Participant Flow|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
11178402|NCT02047032|EG001|Reported Event|Solifenacin Plus PFMT|"Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.~solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )~PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE)."
11192259|NCT02138097|FG000|Participant Flow|United Healthcare|Patients using an oral and non-insulin injected glucose-lowering medication identified from the United Healthcare Research database
10951678|NCT00814255|OG000|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days 0 out of 7"
10951679|NCT00814255|OG001|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day 2 out of 7"
10951680|NCT00814255|OG002|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID 2 out of 7"
10951681|NCT00814255|OG000|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
10951682|NCT00814255|OG001|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
10951683|NCT00814255|OG002|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
10951684|NCT00814255|EG000|Reported Event|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
10951685|NCT00814255|EG001|Reported Event|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
10951686|NCT00814255|EG002|Reported Event|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
10951687|NCT00814307|BG000|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
10951688|NCT00814307|BG001|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
10951689|NCT00814307|BG002|Baseline|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
10951690|NCT00814307|BG003|Baseline|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
10951691|NCT00814307|BG004|Baseline|Total|Total of all reporting groups
10951692|NCT00814307|FG000|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
10951693|NCT00814307|FG001|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
10951694|NCT00814307|FG002|Participant Flow|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
10951695|NCT00814307|FG003|Participant Flow|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
10951696|NCT00814307|OG000|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
10951697|NCT00814307|OG001|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
10951698|NCT00814307|OG002|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
10951699|NCT00814307|OG002|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
10951700|NCT00814307|OG003|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
10951701|NCT00814307|EG000|Reported Event|CP-690550 5 mg (Up To Month 3)|CP-690550 5 mg tablet orally twice daily up to Month 3.
10951702|NCT00814307|EG001|Reported Event|CP-690550 10 mg (Up To Month 3)|CP-690550 10 mg tablet orally twice daily up to Month 3.
10951703|NCT00814307|EG002|Reported Event|Placebo (Up To Month 3)|Matching placebo tablet orally twice daily up to Month 3.
10951704|NCT00814307|EG003|Reported Event|CP-690550 5 mg (Post Month 3)|CP-690550 5 mg tablet orally twice daily from Month 3 to Month 6.
11178403|NCT02047045|BG000|Baseline|Electro-acupuncture|"Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.~EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.~After the EA treatment is stopped, the participants will be followed up for 24 weeks."
10951705|NCT00814307|EG004|Reported Event|CP-690550 10 mg (Post Month 3)|CP-690550 10 mg tablet orally twice daily from Month 3 to Month 6.
10951706|NCT00814320|BG000|Baseline|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
10951707|NCT00814320|BG001|Baseline|12 Years and Older|EPOCH 1: Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of Subcutaneous (SC) infusions Recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV). Participants who previously participated in Study 160601 entered this study at Epoch 2. PK data collected during IV treatment in Study 160601 were used for comparison with PK data from SC treatment during this study (160603). EPOCH 2: (ramp-up and After ramp-up). Participants were treated SC with GAMMAGARD LIQUID/KIOVIG at 108% of IV dose from Epoch 1 or Study 160601. 108% was derived from PK data from Study 160602. Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment (ramp-up), to allow participants to adjust to increasing volume administered SC. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.
10951708|NCT00814320|BG002|Baseline|Total|Total of all reporting groups
10951709|NCT00814320|FG000|Participant Flow|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
10951710|NCT00814320|FG001|Participant Flow|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%. Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study. EPOCH 2 RAMP-UP (ramp-up):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG. EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
10951711|NCT00814320|OG000|Outcome|Full Analysis Data Set (FADS)|All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
11178404|NCT02047045|BG001|Baseline|Prucalopride|"Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.~Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed."
11178405|NCT02047045|BG002|Baseline|Total|Total of all reporting groups
10951712|NCT00814320|OG000|Outcome|% Ratio IgG AUC/Week of SC/ IV|Percentage Ratio of IgG AUC (/Week) after SC administration with rHuPH20/ IgG AUC (/Week) after IV administration of IGIV, 10%
10951713|NCT00814320|OG000|Outcome|%Ratio IgG Trough Level of SC/IV|Percentage Ratio IgGTrough Level after SC administration with rHuPH20/IgG versus after IV administration of IGIV, 10% for participants aged 2 to < 12 years
10951714|NCT00814320|OG000|Outcome|Ratio IgG AUC of SC With and Without rHuPH20|Percentage Ratio of IgG AUC (dose per kg) with and without rHuPH20 for SC administration of IGIV, 10%
10951715|NCT00814320|OG000|Outcome|IV Administration of IGIV, 10%|
10951716|NCT00814320|OG001|Outcome|SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up|
10951717|NCT00814320|OG000|Outcome|Participants Aged 2 to <12 Years|
10951718|NCT00814320|OG001|Outcome|Participants ≥12 Years|
10951719|NCT00814320|OG001|Outcome|Participants ≥ 12 Years|
10951720|NCT00814320|OG001|Outcome|SC Administration of IGIV, 10% With rHuPH20|
10951721|NCT00814320|OG001|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
10951722|NCT00814320|OG001|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|Includes 2 participants who withdrew during ramp-up SC and rHuPH20 administration of IGIV, 10%
10951723|NCT00814320|OG000|Outcome|SC Administration of IGIV, 10% With rHuPH20 at Ramp-up|At start of SC administration of IGIV, 10% with rHuPH20, the first SC dose was a 1-week dose given for a 1-week interval, then if the 1 week SC infusions were tolerated, each week the interval (and dose) was increased by 1 week, until the treatment interval was the same as the interval for intravenous treatment (3 weeks or 4 weeks)
10951724|NCT00814320|OG001|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|
10951725|NCT00814320|OG000|Outcome|Study Epoch 1|Epoch 1 - IV administration of IGIV, 10%
10951726|NCT00814320|OG001|Outcome|Study Epoch 2|Epoch 2 - SC administration of IGIV, 10% with rHuPH20 after ramp-up
10951727|NCT00814320|OG001|Outcome|SC Administration of IGIV, 10% With rHuPH20 With Ramp-up|
10951728|NCT00814320|OG000|Outcome|SC Administration of IGIV, 10% With rHuPH20|
10951729|NCT00814320|OG000|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
10951730|NCT00814320|EG000|Reported Event|IV Administration of IGIV, 10%|Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.
10951731|NCT00814320|EG001|Reported Event|SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)|Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up. Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.
10951732|NCT00814346|BG000|Baseline|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
10951733|NCT00814346|BG001|Baseline|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
10951734|NCT00814346|BG002|Baseline|Total|Total of all reporting groups
10951735|NCT00814346|FG000|Participant Flow|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
10951736|NCT00814346|FG001|Participant Flow|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
10951737|NCT00814346|OG000|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
10951738|NCT00814346|OG001|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg 17 months (open phase) for MC patients
10951739|NCT00814346|OG001|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patient
10951740|NCT00814346|OG001|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
10951741|NCT00814346|OG000|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
11178406|NCT02047045|FG000|Participant Flow|Electro-acupuncture|"Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 min, 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks.~acupuncture: Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks."
10951742|NCT00814346|OG001|Outcome|Placebo (CNE)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
10951743|NCT00814346|OG002|Outcome|EGb761 120 mg (MC)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
10951744|NCT00814346|OG003|Outcome|Placebo (MC)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
10951745|NCT00814346|OG001|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (Open phase) for MC patients
10951746|NCT00814346|OG000|Outcome|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
10951747|NCT00814346|OG001|Outcome|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
10951748|NCT00814346|OG002|Outcome|EGb761 120 mg (Open Phase)|EGb761 120 mg twice a day for 17 months (open phase) for MC and CNE patients
10951749|NCT00814346|OG000|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
10951750|NCT00814346|OG001|Outcome|EGb761 120 mg (MC)|EGb761 120 mg 17 months (open phase) for MC patients
10951751|NCT00814346|EG000|Reported Event|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
10951752|NCT00814346|EG001|Reported Event|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
10951753|NCT00814346|EG002|Reported Event|EGb761 120 mg (Open Phase)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC and CNE patients
10951754|NCT00814463|BG000|Baseline|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
11178407|NCT02047045|FG001|Participant Flow|Prucalopride|"Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast~Prucalopride: Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 8 weeks."
11192260|NCT02138097|FG001|Participant Flow|MarketScan|Patients using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
10951755|NCT00814463|FG000|Participant Flow|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
10951756|NCT00814463|OG000|Outcome|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
10951757|NCT00814463|OG000|Outcome|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~MMSE: Neurocognitive function via MMSE done every 3 months for length of study.~QOL via FACT-Br: Quality of Life via FACT-BR every 3 months for length of study.~MRI: MRI done every 3 months for the length of the study.~Post-operative SRS: Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions."
10951758|NCT00814463|EG000|Reported Event|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
10951759|NCT00814489|BG000|Baseline|GSK2254233A Group|Subjects received 2 doses of GSK2254233A adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2.The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951760|NCT00814489|BG001|Baseline|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted GSK2254232A Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951761|NCT00814489|BG002|Baseline|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951762|NCT00814489|BG003|Baseline|Total|Total of all reporting groups
10951763|NCT00814489|FG000|Participant Flow|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951764|NCT00814489|FG001|Participant Flow|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951765|NCT00814489|FG002|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951766|NCT00814489|OG000|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951767|NCT00814489|OG001|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951768|NCT00814489|OG002|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951769|NCT00814489|OG000|Outcome|GSK2254232A Adjuvanted Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951770|NCT00814489|OG001|Outcome|GSK2254232A Non-adjuvanted Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951771|NCT00814489|EG000|Reported Event|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951772|NCT00814489|EG001|Reported Event|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951773|NCT00814489|EG002|Reported Event|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
10951774|NCT00814502|BG000|Baseline|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951775|NCT00814502|BG001|Baseline|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951776|NCT00814502|BG002|Baseline|Total|Total of all reporting groups
10951777|NCT00814502|FG000|Participant Flow|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Zolpidem CR received Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951778|NCT00814502|FG001|Participant Flow|Placebo|"Subjects randomized to Placebo~After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Placebo received Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951779|NCT00814502|OG000|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951780|NCT00814502|OG001|Outcome|Placebo|"Subjects randomized to Placebo~After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951781|NCT00814502|OG000|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951782|NCT00814502|OG001|Outcome|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951783|NCT00814502|EG000|Reported Event|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951784|NCT00814502|EG001|Reported Event|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
10951785|NCT00814580|BG000|Baseline|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
10951786|NCT00814580|BG001|Baseline|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
10951787|NCT00814580|BG002|Baseline|Total|Total of all reporting groups
10951788|NCT00814580|FG000|Participant Flow|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
10951789|NCT00814580|FG001|Participant Flow|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
10951790|NCT00814580|OG000|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
10951791|NCT00814580|OG001|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
10951792|NCT00814580|OG000|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
10951793|NCT00814580|OG001|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
10951794|NCT00814580|OG002|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
10951795|NCT00814580|OG003|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
10951796|NCT00814580|OG004|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
10951797|NCT00814580|OG005|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
10951798|NCT00814580|OG000|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
10951799|NCT00814580|OG001|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
10951800|NCT00814580|OG002|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
10951801|NCT00814580|OG003|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
10951802|NCT00814580|OG004|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
10951803|NCT00814580|OG005|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
10951804|NCT00814580|EG000|Reported Event|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
10951805|NCT00814580|EG001|Reported Event|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
10951806|NCT00814632|BG000|Baseline|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
10951807|NCT00814632|FG000|Participant Flow|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
10951808|NCT00814632|OG000|Outcome|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
10951809|NCT00814632|EG000|Reported Event|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
10951810|NCT00814658|BG000|Baseline|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951811|NCT00814658|BG001|Baseline|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
10951812|NCT00814658|BG002|Baseline|Total|Total of all reporting groups
10951813|NCT00814658|FG000|Participant Flow|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951814|NCT00814658|FG001|Participant Flow|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
10951815|NCT00814658|OG000|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951816|NCT00814658|OG001|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
11178408|NCT02047045|OG000|Outcome|Electro-acupuncture|"Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.~EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.~After the EA treatment is stopped, the participants will be followed up for 24 weeks."
11178409|NCT02047045|OG001|Outcome|Prucalopride|"Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.~Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed."
10951817|NCT00814658|OG002|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951818|NCT00814658|OG003|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
10951819|NCT00814658|OG004|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951820|NCT00814658|OG005|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
10951821|NCT00814658|OG000|Outcome|Galantamine + Nimodipine (Week 4)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951822|NCT00814658|OG001|Outcome|Galantamine + Placebo (Week 4)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
10951823|NCT00814658|OG004|Outcome|Galantamine + Nimodipine (Week 16)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951824|NCT00814658|OG005|Outcome|Galantamine + Placebo (Week 16)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
10951825|NCT00814658|OG006|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951826|NCT00814658|OG007|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
10951827|NCT00814658|EG000|Reported Event|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
10951828|NCT00814658|EG001|Reported Event|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
10951829|NCT00814671|BG000|Baseline|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951830|NCT00814671|BG001|Baseline|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951831|NCT00814671|BG002|Baseline|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951832|NCT00814671|BG003|Baseline|Total|Total of all reporting groups
10951833|NCT00814671|FG000|Participant Flow|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951834|NCT00814671|FG001|Participant Flow|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951835|NCT00814671|FG002|Participant Flow|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951836|NCT00814671|OG000|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951837|NCT00814671|OG001|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951838|NCT00814671|OG002|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951839|NCT00814671|OG000|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine 450: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951840|NCT00814671|OG002|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine 600: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951841|NCT00814671|OG000|Outcome|Rifapentine 450 mg|Rifapentine 450 mg
10951842|NCT00814671|OG001|Outcome|Rifapentine 600 mg|Rifapentine 600 mg
10951843|NCT00814671|EG000|Reported Event|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951844|NCT00814671|EG001|Reported Event|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951845|NCT00814671|EG002|Reported Event|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
10951846|NCT00814697|BG000|Baseline|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
10951847|NCT00814697|FG000|Participant Flow|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
10951848|NCT00814697|OG000|Outcome|Cognitive Assessment|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
10951849|NCT00814697|EG000|Reported Event|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
10951850|NCT00814710|BG000|Baseline|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
10951851|NCT00814710|BG001|Baseline|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
10951852|NCT00814710|BG002|Baseline|Total|Total of all reporting groups
10951853|NCT00814710|FG000|Participant Flow|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
10951854|NCT00814710|FG001|Participant Flow|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
10951855|NCT00814710|OG000|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
10951856|NCT00814710|OG001|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
10951857|NCT00814710|EG000|Reported Event|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
10951858|NCT00814710|EG001|Reported Event|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
10951859|NCT00814775|BG000|Baseline|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
10951860|NCT00814775|BG001|Baseline|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
10951861|NCT00814775|BG002|Baseline|Total|Total of all reporting groups
11192261|NCT02138097|OG000|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
10951862|NCT00814775|FG000|Participant Flow|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
10951863|NCT00814775|FG001|Participant Flow|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
10951864|NCT00814775|OG000|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
10951865|NCT00814775|OG001|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
10951866|NCT00814775|EG000|Reported Event|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
10951867|NCT00814775|EG001|Reported Event|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
10951868|NCT00814788|BG000|Baseline|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bicalutamide: Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
10951869|NCT00814788|FG000|Participant Flow|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
10951870|NCT00814788|OG000|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bicalutamide: Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
10951871|NCT00814788|OG000|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
10951872|NCT00814788|OG000|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide: 50 mg oral tablet daily~Everolimus: 10 mg oral capsule daily"
10951873|NCT00814788|EG000|Reported Event|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
10951874|NCT00814801|BG000|Baseline|Placebo Group|
10951875|NCT00814801|BG001|Baseline|Galantamine Group 1|Galantamine 16 mg/day
10951876|NCT00814801|BG002|Baseline|Galantamine Group 2|Galantamine 24 mg/day
10951877|NCT00814801|BG003|Baseline|Total|Total of all reporting groups
10951878|NCT00814801|FG000|Participant Flow|Placebo Group|
10951879|NCT00814801|FG001|Participant Flow|Galantamine Group 1|Galantamine 16 mg/day
10951880|NCT00814801|FG002|Participant Flow|Galantamine Group 2|Galantamine 24 mg/day
10951881|NCT00814801|OG000|Outcome|Placebo Group|
10951882|NCT00814801|OG001|Outcome|Galantamine Group 1|Galantamine 16 mg/day
10951883|NCT00814801|OG002|Outcome|Galantamine Group 2|Galantamine 24 mg/day
10951884|NCT00814801|EG000|Reported Event|Placebo Group|
10951885|NCT00814801|EG001|Reported Event|Galantamine Group 1|Galantamine 16 mg/day
10951886|NCT00814801|EG002|Reported Event|Galantamine Group 2|Galantamine 24 mg/day
10951887|NCT00814879|BG000|Baseline|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
10951888|NCT00814879|BG001|Baseline|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
10951889|NCT00814879|BG002|Baseline|Total|Total of all reporting groups
10951890|NCT00814879|FG000|Participant Flow|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
10951891|NCT00814879|FG001|Participant Flow|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
10951892|NCT00814879|OG000|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
10951893|NCT00814879|OG001|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
10951894|NCT00814879|OG000|Outcome|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
10951895|NCT00814879|EG000|Reported Event|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
10951896|NCT00814879|EG001|Reported Event|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
10951897|NCT00814970|BG000|Baseline|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System>~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
10951898|NCT00814970|FG000|Participant Flow|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >~> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
10951899|NCT00814970|OG000|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
10963660|NCT00873119|BG000|Baseline|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
10951900|NCT00814970|OG000|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
10951901|NCT00814970|OG000|Outcome|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >~> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
10951902|NCT00814970|EG000|Reported Event|1. Complete SE Vascular Stent System|Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
10951903|NCT00815035|BG000|Baseline|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
10951904|NCT00815035|BG001|Baseline|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
10951905|NCT00815035|BG002|Baseline|Total|Total of all reporting groups
10951906|NCT00815035|FG000|Participant Flow|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
11178410|NCT02047045|EG000|Reported Event|Electro-acupuncture|"Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.~EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.~After the EA treatment is stopped, the participants will be followed up for 24 weeks."
10951907|NCT00815035|FG001|Participant Flow|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
10951908|NCT00815035|FG002|Participant Flow|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
10951909|NCT00815035|OG000|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
10951910|NCT00815035|OG000|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
10951911|NCT00815035|OG001|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
11178411|NCT02047045|EG001|Reported Event|Prucalopride|"Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.~Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed."
10951912|NCT00815035|OG002|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
10951913|NCT00815035|EG000|Reported Event|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
10951914|NCT00815035|EG001|Reported Event|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
10951915|NCT00815035|EG002|Reported Event|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
10951916|NCT00815087|BG000|Baseline|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
10951917|NCT00815087|BG001|Baseline|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
10951918|NCT00815087|BG002|Baseline|Total|Total of all reporting groups
10951919|NCT00815087|FG000|Participant Flow|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
10951920|NCT00815087|FG001|Participant Flow|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
10951921|NCT00815087|OG000|Outcome|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
10951922|NCT00815087|OG001|Outcome|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
10951923|NCT00815087|EG000|Reported Event|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
10951924|NCT00815087|EG001|Reported Event|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
10951925|NCT00815191|BG000|Baseline|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
10951926|NCT00815191|BG001|Baseline|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
10951927|NCT00815191|BG002|Baseline|Total|Total of all reporting groups
10951928|NCT00815191|FG000|Participant Flow|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
10951929|NCT00815191|FG001|Participant Flow|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
10951930|NCT00815191|OG000|Outcome|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
10951931|NCT00815191|OG001|Outcome|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
10951932|NCT00815191|EG000|Reported Event|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
11178412|NCT02047110|BG000|Baseline|Placebo|Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
10951933|NCT00815191|EG001|Reported Event|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
10951934|NCT00815295|BG000|Baseline|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
11178413|NCT02047110|BG001|Baseline|Risankizumab 18 mg|Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
11178414|NCT02047110|BG002|Baseline|Risankizumab 90 mg|Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
10951935|NCT00815295|BG001|Baseline|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
10951936|NCT00815295|BG002|Baseline|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
10951937|NCT00815295|BG003|Baseline|Total|Total of all reporting groups
10951938|NCT00815295|FG000|Participant Flow|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
10951939|NCT00815295|FG001|Participant Flow|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
10951940|NCT00815295|FG002|Participant Flow|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
10951941|NCT00815295|OG000|Outcome|Phase 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg or 400 mg was administered orally twice daily. The dose of sorafenib was escalated from 200 mg to 400 mg in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT).
10951942|NCT00815295|OG000|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
10951943|NCT00815295|OG000|Outcome|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
10951944|NCT00815295|EG000|Reported Event|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg/m2 was administered orally twice daily.
10951945|NCT00815295|EG001|Reported Event|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg/m2 was administered orally twice daily.
10951946|NCT00815295|EG002|Reported Event|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
11178415|NCT02047110|BG003|Baseline|Risankizumab 180 mg|Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
11178416|NCT02047110|BG004|Baseline|Total|Total of all reporting groups
10951947|NCT00815308|BG000|Baseline|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
10951948|NCT00815308|FG000|Participant Flow|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
10951949|NCT00815308|OG000|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
10951950|NCT00815308|EG000|Reported Event|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
10951951|NCT00815347|BG000|Baseline|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
10951952|NCT00815347|FG000|Participant Flow|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
10951953|NCT00815347|OG000|Outcome|Placebo|
10951954|NCT00815347|OG001|Outcome|Bosentan|
11178417|NCT02047110|FG000|Participant Flow|Placebo|Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
10951955|NCT00815347|EG000|Reported Event|Bosentan|Bosentan 62.5mg orally, twice a day for four weeks.
10951956|NCT00815347|EG001|Reported Event|Placebo|Placebo orally, twice a day for four weeks.
10951957|NCT00815360|BG000|Baseline|Treatment Group 1|ranibizumab and scatter laser
10951958|NCT00815360|BG001|Baseline|Comparative Group 1|Intravitreal triamcinolone with macular laser
10951959|NCT00815360|BG002|Baseline|Total|Total of all reporting groups
10951960|NCT00815360|FG000|Participant Flow|Treatment Group 1|ranibizumab and scatter laser
10951961|NCT00815360|FG001|Participant Flow|Comparative Group 1|Intravitreal triamcinolone with macular laser
10951962|NCT00815360|OG000|Outcome|Treatment Group 1|ranibizumab and scatter laser
10951963|NCT00815360|OG001|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
10951964|NCT00815360|EG000|Reported Event|Treatment Group 1|Intravitreal ranibizumab and peripheral laser
10951965|NCT00815360|EG001|Reported Event|Comparative Group 1|Intravitreal triamcinolone acetonide and macular laser
10951966|NCT00815490|BG000|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
10951967|NCT00815490|BG001|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
10951968|NCT00815490|BG002|Baseline|Total|Total of all reporting groups
10951969|NCT00815490|FG000|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
10951970|NCT00815490|FG001|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
10951971|NCT00815490|OG000|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
10951972|NCT00815490|OG001|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
10951973|NCT00815490|EG000|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
10951974|NCT00815490|EG001|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
10951975|NCT00815516|BG000|Baseline|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
10951976|NCT00815516|BG001|Baseline|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
10951977|NCT00815516|BG002|Baseline|Total|Total of all reporting groups
10951978|NCT00815516|FG000|Participant Flow|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
10951979|NCT00815516|FG001|Participant Flow|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
10951980|NCT00815516|OG000|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
10963661|NCT00873119|BG001|Baseline|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
11178418|NCT02047110|FG001|Participant Flow|Risankizumab 18 mg|Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
10951981|NCT00815516|OG001|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
10951982|NCT00815516|EG000|Reported Event|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
10951983|NCT00815516|EG001|Reported Event|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
10951984|NCT00815659|BG000|Baseline|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
10951985|NCT00815659|FG000|Participant Flow|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
10951986|NCT00815659|OG000|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
10951987|NCT00815659|EG000|Reported Event|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
10951988|NCT00815685|BG000|Baseline|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
10951989|NCT00815685|FG000|Participant Flow|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
10951990|NCT00815685|OG000|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
10951991|NCT00815685|EG000|Reported Event|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
10951992|NCT00815698|BG000|Baseline|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
10951993|NCT00815698|BG001|Baseline|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
10951994|NCT00815698|BG002|Baseline|Total|Total of all reporting groups
10951995|NCT00815698|FG000|Participant Flow|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
10951996|NCT00815698|FG001|Participant Flow|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
10951997|NCT00815698|OG000|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
10951998|NCT00815698|OG001|Outcome|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
10951999|NCT00815698|EG000|Reported Event|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
10952000|NCT00815698|EG001|Reported Event|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
11178419|NCT02047110|FG002|Participant Flow|Risankizumab 90 mg|Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
10952001|NCT00815776|BG000|Baseline|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
10952002|NCT00815776|BG001|Baseline|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
10952003|NCT00815776|BG002|Baseline|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
10952004|NCT00815776|BG003|Baseline|Total|Total of all reporting groups
10952005|NCT00815776|FG000|Participant Flow|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
10952006|NCT00815776|FG001|Participant Flow|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
10952007|NCT00815776|FG002|Participant Flow|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
10952008|NCT00815776|OG000|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
10952009|NCT00815776|OG001|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
10952010|NCT00815776|OG002|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
10952011|NCT00815776|OG000|Outcome|Clayton Intra-aural Device (CID) Group|This group of subjects received the Clayton Intra-aural Device
10952012|NCT00815776|OG001|Outcome|Mouth Splint Group|This group was not part of the analysis
10952013|NCT00815776|OG002|Outcome|Jaw Exercise Group|This subject group received no device but was assigned to complete a study-specified jaw exercise program
10952014|NCT00815776|EG000|Reported Event|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
10952015|NCT00815776|EG001|Reported Event|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
10952016|NCT00815776|EG002|Reported Event|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
10952017|NCT00815919|BG000|Baseline|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
10952018|NCT00815919|FG000|Participant Flow|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
10952019|NCT00815919|OG000|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
10963662|NCT00873119|BG002|Baseline|Total|Total of all reporting groups
11192262|NCT02138097|OG001|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
10952020|NCT00815919|EG000|Reported Event|Velcade (Bortezomib)|"Prednisone : Taken orally once a day. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~bortezomib : Given intravenously once a week for the first four weeks of a five week cycle for a total of 3 cycles"
10952021|NCT00815997|BG000|Baseline|6 Fr TRI|TRI will be performed using a 6-Fr guiding catheter.
10952022|NCT00815997|BG001|Baseline|4-Fr TRI|"TRI will be performed using a 4-Fr guiding catheter.~TRI using a 4-Fr guiding catheter: TRI will be performed using a 4-Fr guiding catheter."
10952023|NCT00815997|BG002|Baseline|Total|Total of all reporting groups
10952024|NCT00815997|FG000|Participant Flow|6 Fr TRI|TRI will be performed using a 6-Fr guiding catheter.
10952025|NCT00815997|FG001|Participant Flow|4-Fr TRI|TRI will be performed using a 4-Fr guiding catheter.
10952026|NCT00815997|OG000|Outcome|6 Fr TRI|TRI will be performed using a 6-Fr guiding catheter.
10952027|NCT00815997|OG001|Outcome|4-Fr TRI|TRI will be performed using a 4-Fr guiding catheter.
10952028|NCT00815997|OG000|Outcome|6-Fr TRI (Transradial Coronary Intervention)|"TRI will be performed using a 6-Fr guiding catheter.~PCI (percutaneous coronary intervention): PCI will be performed via the radial artery."
10952029|NCT00815997|OG001|Outcome|4-Fr TRI|"TRI will be performed using a 4-Fr guiding catheter.~PCI (percutaneous coronary intervention): PCI will be performed via the radial artery."
10952030|NCT00815997|EG000|Reported Event|6 Fr TRI|TRI will be performed using a 6-Fr guiding catheter.
10952031|NCT00815997|EG001|Reported Event|4-Fr TRI|TRI will be performed using a 4-Fr guiding catheter.
10952032|NCT00816023|BG000|Baseline|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
10952033|NCT00816023|BG001|Baseline|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
10952034|NCT00816023|BG002|Baseline|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
10952035|NCT00816023|BG003|Baseline|Placebo|
10952036|NCT00816023|BG004|Baseline|Total|Total of all reporting groups
10952037|NCT00816023|FG000|Participant Flow|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
10952038|NCT00816023|FG001|Participant Flow|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
11178420|NCT02047110|FG003|Participant Flow|Risankizumab 180 mg|Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
11192263|NCT02138097|OG002|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
10952039|NCT00816023|FG002|Participant Flow|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
10952040|NCT00816023|FG003|Participant Flow|Placebo|
10952041|NCT00816023|OG000|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
10952042|NCT00816023|OG001|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
10952043|NCT00816023|OG002|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
10952044|NCT00816023|OG003|Outcome|Placebo|
10952045|NCT00816023|EG000|Reported Event|ECALLANTIDE HIGH DOSE|Target steady state concentration of 2.25 mg/L
10952046|NCT00816023|EG001|Reported Event|ECALLANTIDE MEDIUM DOSE|Target steady state concentration of 0.75 mg/L
10952047|NCT00816023|EG002|Reported Event|ECALLANTIDE LOW DOSE|Target steady state concentration of 0.15 mg/L
10952048|NCT00816023|EG003|Reported Event|PLACEBO|
10952049|NCT00816036|BG000|Baseline|Arm 1|Pre-intervention Period
10952050|NCT00816036|BG001|Baseline|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
10952051|NCT00816036|BG002|Baseline|Total|Total of all reporting groups
10952052|NCT00816036|FG000|Participant Flow|Pre-intervention Period|Pre-intervention Period
10952053|NCT00816036|FG001|Participant Flow|Intervention Period|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
10952054|NCT00816036|OG000|Outcome|Arm 1|Pre-intervention Period
10952055|NCT00816036|OG001|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
10952056|NCT00816036|EG000|Reported Event|Arm 1|Pre-intervention Period
10952057|NCT00816036|EG001|Reported Event|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
10952058|NCT00816062|BG000|Baseline|Treatment|"Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.>~> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement."
10952059|NCT00816062|FG000|Participant Flow|Talent Abdominal Stent Graft|"Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the Food and Drug Administration (FDA) approved Instructions for Use (IFU).~>~> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement."
10952060|NCT00816062|OG000|Outcome|Treatment|"Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.>~> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement."
10952061|NCT00816062|EG000|Reported Event|1. Vitality|Medtronic Vitality
10952062|NCT00816062|EG001|Reported Event|2. ELPS|Medtronic ELPS
10952063|NCT00816101|BG000|Baseline|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
10952064|NCT00816101|BG001|Baseline|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
10952065|NCT00816101|BG002|Baseline|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
10952066|NCT00816101|BG003|Baseline|Total|Total of all reporting groups
10952067|NCT00816101|FG000|Participant Flow|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
10952068|NCT00816101|FG001|Participant Flow|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
10952069|NCT00816101|FG002|Participant Flow|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
10952070|NCT00816101|OG000|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
10952071|NCT00816101|OG001|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
10952072|NCT00816101|OG002|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
10952073|NCT00816101|EG000|Reported Event|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
10952074|NCT00816101|EG001|Reported Event|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
10952075|NCT00816101|EG002|Reported Event|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
10952076|NCT00816166|BG000|Baseline|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
10952077|NCT00816166|BG001|Baseline|Medical Therapy Group|"Medical therapy alone (Medical Therapy Group)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
10952078|NCT00816166|BG002|Baseline|Total|Total of all reporting groups
10952079|NCT00816166|FG000|Participant Flow|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
10952080|NCT00816166|FG001|Participant Flow|Medical Therapy Group|"Medical therapy alone (Medical Therapy Group)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
10952081|NCT00816166|OG000|Outcome|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
10952082|NCT00816166|OG001|Outcome|Medical Therapy Group|"Medical therapy alone (Medical Therapy Group)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
10952083|NCT00816166|EG000|Reported Event|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
10952084|NCT00816166|EG001|Reported Event|Medical Therapy Group|"Medical therapy alone (Medical Therapy Group)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
10952085|NCT00816348|BG000|Baseline|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
10963663|NCT00873119|FG000|Participant Flow|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
10952086|NCT00816348|FG000|Participant Flow|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
10952087|NCT00816348|OG000|Outcome|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
10952088|NCT00816348|EG000|Reported Event|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
10952089|NCT00816361|BG000|Baseline|MEDI-573 0.5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952090|NCT00816361|BG001|Baseline|MEDI-573 1.5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952091|NCT00816361|BG002|Baseline|MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion|Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952092|NCT00816361|BG003|Baseline|MEDI-573 10 mg/Kg QWk Dose Escalation|Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952093|NCT00816361|BG004|Baseline|MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion|Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952094|NCT00816361|BG005|Baseline|MEDI-573 30 mg/Kg Q3Wk Dose Escalation|Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952095|NCT00816361|BG006|Baseline|MEDI-573 45 mg/Kg Q3Wk Dose Escalation|Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952096|NCT00816361|BG007|Baseline|TOTAL|Total of all reporting groups
11178421|NCT02047110|OG000|Outcome|Placebo|Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
11178422|NCT02047110|OG001|Outcome|Risankizumab 18 mg|Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
11178423|NCT02047110|OG002|Outcome|Risankizumab 90 mg|Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
10952097|NCT00816361|FG000|Participant Flow|MEDI-573 0.5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952098|NCT00816361|FG001|Participant Flow|MEDI-573 1.5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952099|NCT00816361|FG002|Participant Flow|MEDI-573 5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952100|NCT00816361|FG003|Participant Flow|MEDI-573 10 mg/Kg QWk Dose Escalation|Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952101|NCT00816361|FG004|Participant Flow|MEDI-573 15 mg/Kg QWk Dose Escalation|Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952102|NCT00816361|FG005|Participant Flow|MEDI-573 30 mg/Kg Q3Wk Dose Escalation|Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952103|NCT00816361|FG006|Participant Flow|MEDI-573 45 mg/Kg Q3Wk Dose Escalation|Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
11178424|NCT02047110|OG003|Outcome|Risankizumab 180 mg|Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
11192264|NCT02138097|OG003|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
10952104|NCT00816361|FG007|Participant Flow|MEDI-573 5 mg/Kg QWk Dose Expansion|Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952105|NCT00816361|FG008|Participant Flow|MEDI-573 15 mg/Kg QWk Dose Expansion|Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952106|NCT00816361|OG000|Outcome|MEDI-573 0.5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952107|NCT00816361|OG001|Outcome|MEDI-573 1.5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952108|NCT00816361|OG002|Outcome|MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion|Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952109|NCT00816361|OG003|Outcome|MEDI-573 10 mg/Kg QWk Dose Escalation|Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952110|NCT00816361|OG004|Outcome|MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion|Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952111|NCT00816361|OG005|Outcome|MEDI-573 30 mg/Kg Q3Wk Dose Escalation|Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952112|NCT00816361|OG006|Outcome|MEDI-573 45 mg/Kg Q3Wk Dose Escalation|Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952113|NCT00816361|OG000|Outcome|MEDI-573 Dose Escalation|Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) up to 15 mg/kg as a 60-minute intravenous (IV) infusion once every 7 days or up to 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952114|NCT00816361|OG002|Outcome|MEDI-573 5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952115|NCT00816361|OG004|Outcome|MEDI-573 15 mg/Kg QWk Dose Escalation|Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952116|NCT00816361|OG007|Outcome|MEDI-573 5 mg/Kg QWk Dose Expansion|Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952117|NCT00816361|OG008|Outcome|MEDI-573 15 mg/Kg QWk Dose Expansion|Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
11178425|NCT02047110|EG000|Reported Event|Placebo|Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
11178426|NCT02047110|EG001|Reported Event|Risankizumab 18 mg|Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
10952118|NCT00816361|EG000|Reported Event|MEDI-573 0.5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952119|NCT00816361|EG001|Reported Event|MEDI-573 1.5 mg/Kg QWk Dose Escalation|Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952120|NCT00816361|EG002|Reported Event|MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion|Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952121|NCT00816361|EG003|Reported Event|MEDI-573 10 mg/Kg QWk Dose Escalation|Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952122|NCT00816361|EG004|Reported Event|MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion|Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952123|NCT00816361|EG005|Reported Event|MEDI-573 30 mg/Kg Q3Wk Dose Escalation|Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952124|NCT00816361|EG006|Reported Event|MEDI-573 45 mg/Kg Q3Wk Dose Escalation|Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10952125|NCT00816400|BG000|Baseline|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
11178427|NCT02047110|EG002|Reported Event|Risankizumab 90 mg|Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
10952126|NCT00816400|BG001|Baseline|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952127|NCT00816400|BG002|Baseline|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952128|NCT00816400|BG003|Baseline|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952129|NCT00816400|BG004|Baseline|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952130|NCT00816400|BG005|Baseline|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952131|NCT00816400|BG006|Baseline|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
11178428|NCT02047110|EG003|Reported Event|Risankizumab 180 mg|Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
11178429|NCT02047110|EG004|Reported Event|Escape Low|Patients who received risankizumab 180 mg in the Escape treatment period and who were randomized to either Placebo or risankizumab 18 mg at Day 1 of the DB treatment period
11178430|NCT02047110|EG005|Reported Event|Escape High|Patients who received risankizumab 180 mg in the Escape treatment period and who were randomized to either risankizumab 90 mg or risankizumab 180 mg at Day 1 of the DB treatment period
10952132|NCT00816400|BG007|Baseline|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952133|NCT00816400|BG008|Baseline|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952134|NCT00816400|BG009|Baseline|Total|Total of all reporting groups
10952135|NCT00816400|FG000|Participant Flow|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952136|NCT00816400|FG001|Participant Flow|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952137|NCT00816400|FG002|Participant Flow|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952138|NCT00816400|FG003|Participant Flow|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952139|NCT00816400|FG004|Participant Flow|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952140|NCT00816400|FG005|Participant Flow|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952141|NCT00816400|FG006|Participant Flow|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
11178431|NCT02047110|EG006|Reported Event|Escape|Patients who received escape treatments of risankizumab 180 mg regardless of the initial randomization group
11178432|NCT02047110|EG007|Reported Event|Open Label Extension (OLE)|Patients who received 180 mg risankizumab (administered subcutaneously) every 8 weeks in OLE treatment period
11178433|NCT02047110|EG008|Reported Event|Risankizumab High|Patients who received at least one risankizumab 90 mg or 180 mg treatment during the entire trial
11178434|NCT02047110|EG009|Reported Event|Risankizumab Total|Patients who received at least one risankizumab treatment at any dose level
11178435|NCT02047110|EG010|Reported Event|Total_all|All randomised patients
11192265|NCT02138097|OG004|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
10952142|NCT00816400|FG007|Participant Flow|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952143|NCT00816400|FG008|Participant Flow|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952144|NCT00816400|OG000|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952145|NCT00816400|OG001|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952146|NCT00816400|OG002|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952147|NCT00816400|OG003|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952148|NCT00816400|OG004|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952149|NCT00816400|OG005|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
11192266|NCT02138097|OG005|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
11192267|NCT02138097|OG006|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
10952150|NCT00816400|OG006|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952151|NCT00816400|OG007|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952152|NCT00816400|OG008|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952153|NCT00816400|OG007|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
10952154|NCT00816400|OG008|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952155|NCT00816400|OG009|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952156|NCT00816400|EG000|Reported Event|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952157|NCT00816400|EG001|Reported Event|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952158|NCT00816400|EG002|Reported Event|MEDI-575, 9.0 mg/kg QWk Escalation/Expansion Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21 day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952159|NCT00816400|EG003|Reported Event|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952160|NCT00816400|EG004|Reported Event|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952161|NCT00816400|EG005|Reported Event|MEDI-575, 25 mg/kg Q3Wk Escalation/Expansion Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
11178436|NCT02047227|BG000|Baseline|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.
11178437|NCT02047227|BG001|Baseline|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.
10952162|NCT00816400|EG006|Reported Event|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
10952163|NCT00816556|BG000|Baseline|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952164|NCT00816556|BG001|Baseline|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952165|NCT00816556|BG002|Baseline|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952166|NCT00816556|BG003|Baseline|Total|Total of all reporting groups
10952167|NCT00816556|FG000|Participant Flow|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952168|NCT00816556|FG001|Participant Flow|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952169|NCT00816556|FG002|Participant Flow|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952170|NCT00816556|OG000|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952171|NCT00816556|OG001|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952172|NCT00816556|OG002|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952173|NCT00816556|EG000|Reported Event|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952174|NCT00816556|EG001|Reported Event|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952175|NCT00816556|EG002|Reported Event|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
10952176|NCT00816595|BG000|Baseline|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10952177|NCT00816595|BG001|Baseline|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11178438|NCT02047227|BG002|Baseline|Total|Total of all reporting groups
11178439|NCT02047227|FG000|Participant Flow|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.
10952178|NCT00816595|BG002|Baseline|Total|Total of all reporting groups
10952179|NCT00816595|FG000|Participant Flow|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
10952180|NCT00816595|FG001|Participant Flow|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
10952181|NCT00816595|OG000|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10952182|NCT00816595|OG001|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10952183|NCT00816595|OG000|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
10952184|NCT00816595|OG001|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
10952185|NCT00816595|EG000|Reported Event|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
10952186|NCT00816595|EG001|Reported Event|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
10952187|NCT00816751|BG000|Baseline|Paracervical Block|All patients who met inclusion criteria were approached for the study. Exclusion criteria included gestational age greater than 12 weeks, patient age less than 18, patient weight less than 44 kg, patient allergy to any component of the local anesthetic, patient need for general anesthesia, inability to understand the consent form, nonviable pregnancy, current incarceration.
10952188|NCT00816751|BG001|Baseline|Intracervical Block|All patients who met inclusion criteria were approached for the study. Exclusion criteria included gestational age greater than 12 weeks, patient age less than 18, patient weight less than 44 kg, patient allergy to any component of the local anesthetic, patient need for general anesthesia, inability to understand the consent form, nonviable pregnancy, current incarceration.
10952189|NCT00816751|BG002|Baseline|Total|Total of all reporting groups
10952190|NCT00816751|FG000|Participant Flow|Paracervical Block|"Paracervical block: The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.~Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate."
10952191|NCT00816751|FG001|Participant Flow|Intracervical Block|"Intracervical: The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.~Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate."
10952192|NCT00816751|OG000|Outcome|Paracervical Block|"Paracervical block: The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.~Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate."
10963664|NCT00873119|FG001|Participant Flow|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
11192268|NCT02138097|OG007|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
11192269|NCT02138097|OG008|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
10952193|NCT00816751|OG001|Outcome|Intracervical Block|"Intracervical: The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.~Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate."
10952194|NCT00816751|EG000|Reported Event|Paracervical Block|"Paracervical block: The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.~Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate."
10952195|NCT00816751|EG001|Reported Event|Intracervical Block|"Intracervical: The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.~Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate."
10952196|NCT00816829|BG000|Baseline|Placebo|Placebo
10952197|NCT00816829|BG001|Baseline|Fenofibrate|Fenofibrate 145 mg
10952198|NCT00816829|BG002|Baseline|Total|Total of all reporting groups
10952199|NCT00816829|FG000|Participant Flow|Placebo|Placebo
10952200|NCT00816829|FG001|Participant Flow|Fenofibrate|Fenofibrate 145 mg
10952201|NCT00816829|OG000|Outcome|Placebo|Placebo
10952202|NCT00816829|OG001|Outcome|Fenofibrate|Fenofibrate 145 mg
10952203|NCT00816829|EG000|Reported Event|Placebo|Placebo
10952204|NCT00816829|EG001|Reported Event|Fenofibrate|Fenofibrate 145 mg
10952205|NCT00816907|BG000|Baseline|Placebo|Matching over-encapsulated placebo pills
11178440|NCT02047227|FG001|Participant Flow|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.
10952206|NCT00816907|BG001|Baseline|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
10952207|NCT00816907|BG002|Baseline|Total|Total of all reporting groups
10952208|NCT00816907|FG000|Participant Flow|Placebo|Matching over-encapsulated placebo pills
10952209|NCT00816907|FG001|Participant Flow|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
10952210|NCT00816907|OG000|Outcome|Placebo|Matching over-encapsulated placebo pills
10952211|NCT00816907|OG001|Outcome|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
10952212|NCT00816907|OG000|Outcome|Placebo|
10952213|NCT00816907|OG001|Outcome|Metformin|
10952214|NCT00816907|EG000|Reported Event|Placebo|Matching over-encapsulated placebo pills
10952215|NCT00816907|EG001|Reported Event|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
10952216|NCT00817063|BG000|Baseline|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
10952217|NCT00817063|BG001|Baseline|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
10952218|NCT00817063|BG002|Baseline|Total|Total of all reporting groups
10952219|NCT00817063|FG000|Participant Flow|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 milligrams (mg) of alitretinoin oral soft capsule once daily up to 24 weeks.
10952220|NCT00817063|FG001|Participant Flow|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
10952221|NCT00817063|OG000|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
10952222|NCT00817063|OG001|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
10952223|NCT00817063|EG000|Reported Event|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
10952224|NCT00817063|EG001|Reported Event|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
10952225|NCT00817089|BG000|Baseline|Group 1: Asn40 Placebo Placebo|"Asn40: Placebo, Placebo~Each alcohol challenge session preceded by pretreatment with placebo~Placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952226|NCT00817089|BG001|Baseline|Group 2: Asn40 Placebo Naltrexone|"Asn40: Placebo, Naltrexone~The first alcohol challenge session preceded by pretreatment with placebo. The second challegne alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.~Placebo: placebo pills~naltrexone: 50 mg of naltrexone prior to challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952227|NCT00817089|BG002|Baseline|Group 3: Asp40 Placebo Placebo|"Asp40: Placebo, Placebo~Each alcohol challenge session preceded by pretreatment with placebo~Placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952228|NCT00817089|BG003|Baseline|Group 4: Asp40 Placebo Naltrexone|"Asp40: Placebo, Naltrexone~The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.~Placebo: placebo pills~naltrexone: 50 mg of naltrexone prior to challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952229|NCT00817089|BG004|Baseline|Total|Total of all reporting groups
10952230|NCT00817089|FG000|Participant Flow|Group 1: Asn40 Placebo Placebo|"Asn40: Placebo, Placebo~Each alcohol session preceded by pretreatment with placebo.~Placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952231|NCT00817089|FG001|Participant Flow|Group 2: Asn40 Placebo Naltrexone|"Asn40: Placebo, Naltrexone~The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.~Placebo: placebo pills~naltrexone: 50 mg of naltrexone prior to challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952232|NCT00817089|FG002|Participant Flow|Group 3: Asp40 Placebo Placebo|"Asp40: Placebo, Placebo~Each alcohol challenge session preceded by pretreatment with placebo.~Placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952233|NCT00817089|FG003|Participant Flow|Group 4: Asp40 Placebo Naltrexone|"Asp40: Placebo, Naltrexone~The first alcohol challenge session preceded by pretreatment with placebo. The second challegne alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.~Placebo: placebo pills~naltrexone: 50 mg of naltrexone prior to challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952234|NCT00817089|OG000|Outcome|Group 1: Asn40 Placebo Placebo|"Asn40: Placebo, Placebo~Each alcohol challenge session preceded by pretreatment with placebo.~Placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952235|NCT00817089|OG001|Outcome|Group 2: Asn40 Placebo Naltrexone|"Asn40: Placebo, Naltrexone~The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.~Placebo: placebo pills~naltrexone: 50 mg of naltrexone prior to challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952236|NCT00817089|OG002|Outcome|Group 3: Asp40 Placebo Placebo|"Asp40: Placebo, Placebo~Each alcohol challenge session preceded by pretreatment with placebo.~Placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952237|NCT00817089|OG003|Outcome|Group 4: Asp40 Placebo Naltrexone|"Asp40: Placebo, Naltrexone~The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.~Placebo: placebo pills~naltrexone: 50 mg of naltrexone prior to challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952238|NCT00817089|OG000|Outcome|Group 1 Asn40 Placebo Placebo|"Asn40: Placebo, Placebo~Each alcohol challenge session preceded by pretreatment with placebo.~Placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952239|NCT00817089|OG001|Outcome|Group 2 Asn40 Placebo Naltrexone|"Asn40: Placebo, Naltrexone~The first alcohol challegne session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.~Placebo: placebo pills~Naltrexone: 50 mg of naltrexone prior to challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952240|NCT00817089|OG002|Outcome|Group 3 Asp40 Placebo Placebo|"Asp40: Placebo, Placebo Each alcohol challenge session preceded by pretreatment with placebo oral tablet~Placebo Oral Tablet: Placebo pill~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952241|NCT00817089|OG003|Outcome|Group 4 Asp40 Placebo Naltrexone|"Asp40: Placebo, Naltrexone~The first alcohol challenge session preceded by pretreatment with placebo oral tablet. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.~Placebo Oral Tablet: Placebo pill~Naltrexone: 50 mg of naltrexone prior to challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952242|NCT00817089|EG000|Reported Event|Group 1: Asn40 Placebo Placebo|"Asn40: placebo, placebo~Each alcohol challenge session preceded by pretreatment with placebo.~placebo: placebo pills~alcohol : 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952243|NCT00817089|EG001|Reported Event|Group 2: Asn40 Placebo Naltrexone|"Asn40: placebo, naltrexone~The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.~placebo: placebo pills~naltrexone : 50 mg of naltrexone prior to challenge session~alcohol : 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952244|NCT00817089|EG002|Reported Event|Group 3: Asp40 Placebo Placebo|"Asp40: placebo, placebo prior~Each alcohol challenge session preceded by pretreatment with placebo.~placebo: placebo pills~alcohol : 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952245|NCT00817089|EG003|Reported Event|Group 4: Asp40 Placebo Naltrexone|"Asp40: placebo, naltrexone~The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.~placebo: placebo pills~naltrexone : 50 mg of naltrexone prior to challenge session~alcohol : 190 proof alcohol prepared to 11% volume mixed with fruit juice"
10952246|NCT00817206|BG000|Baseline|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
11192270|NCT02138097|OG007|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
10952247|NCT00817206|BG001|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
10952248|NCT00817206|BG002|Baseline|Total|Total of all reporting groups
11192271|NCT02138097|OG008|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
10952249|NCT00817206|FG000|Participant Flow|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
10952250|NCT00817206|FG001|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
10952251|NCT00817206|OG000|Outcome|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
10952252|NCT00817206|OG001|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
10952253|NCT00817206|EG000|Reported Event|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
10952254|NCT00817206|EG001|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
10952255|NCT00817219|BG000|Baseline|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
10952256|NCT00817219|FG000|Participant Flow|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
10952257|NCT00817219|OG000|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
10952258|NCT00817219|EG000|Reported Event|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
10952259|NCT00817336|BG000|Baseline|D-serine Followed by Placebo|Does not include 1 drop-out during phase 1
10952260|NCT00817336|BG001|Baseline|Placebo Followed by D-serine|Does not include 1 drop-out during phase 1
10952261|NCT00817336|BG002|Baseline|Total|Total of all reporting groups
10952262|NCT00817336|FG000|Participant Flow|D-serine Followed by Placebo|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
10952263|NCT00817336|FG001|Participant Flow|Placebo Followed by D-serine|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
10952264|NCT00817336|OG000|Outcome|D-serine|"60 mg/kg/day~D Serine: 60 mg/kg/day"
10952265|NCT00817336|OG001|Outcome|Placebo|Placebo: oral
10952266|NCT00817336|EG000|Reported Event|D-serine/Placebo Crossover|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
10952267|NCT00817414|BG000|Baseline|Cohort A: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks.
10952268|NCT00817414|BG001|Baseline|Cohort A: LCI699 1 mg QD|Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
10952269|NCT00817414|BG002|Baseline|Cohort B1: LCI699 1 mg BID|Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.
10952270|NCT00817414|BG003|Baseline|Cohort B1: LCI699 2 mg QD|Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
10952271|NCT00817414|BG004|Baseline|Placebo|Participants received LCI699-matching placebo, capsules, orally, QD or BID with or without food for up to 6 weeks.
10952272|NCT00817414|BG005|Baseline|Total|Total of all reporting groups
10952273|NCT00817414|FG000|Participant Flow|Cohort A: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks.
10952274|NCT00817414|FG001|Participant Flow|Cohort A: LCI699 1 mg QD|Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
10952275|NCT00817414|FG002|Participant Flow|Cohort B1: LCI699 1 mg BID|Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.
10952276|NCT00817414|FG003|Participant Flow|Cohort B1: LCI699 2 mg QD|Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
10952277|NCT00817414|FG004|Participant Flow|Placebo|Participants received LCI699-matching placebo, capsules, orally, QD or BID with or without food for up to 6 weeks.
10952278|NCT00817414|OG000|Outcome|LCI699|Participants received LCI699 capsules, orally, QD or BID, with or without food for up to 6 weeks.
10952279|NCT00817414|OG000|Outcome|Cohort A: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks.
10952280|NCT00817414|OG001|Outcome|Cohort A: LCI699 1.0 mg QD|Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
10952281|NCT00817414|OG002|Outcome|Cohort B1: LCI699 1.0 mg BID|Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.
10952282|NCT00817414|OG003|Outcome|Cohort B1: LCI699 2.0 mg QD|Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
10952283|NCT00817414|OG004|Outcome|Placebo|Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks.
10952284|NCT00817414|OG001|Outcome|Cohort A: LCI699 1 mg QD|Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
10952285|NCT00817414|OG002|Outcome|Cohort B1: LCI699 1 mg BID|Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.
10952286|NCT00817414|OG003|Outcome|Cohort B1: LCI699 2 mg QD|Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
11178441|NCT02047227|OG000|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.
11178442|NCT02047227|OG001|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.
10952287|NCT00817414|OG004|Outcome|Placebo|Participants received LCI699-matching placebo, capsules, orally, QD or BID with or without food for up to 6 weeks.
10952288|NCT00817414|EG000|Reported Event|Cohort A: LCI699 0.5 mg QD|Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks.
10952289|NCT00817414|EG001|Reported Event|Cohort A: LCI699 1.0 mg QD|Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
11192272|NCT02138097|OG009|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
11192273|NCT02138097|EG000|Reported Event|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
10952290|NCT00817414|EG002|Reported Event|Cohort B1: LCI699 1.0 mg BID|Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.
10952291|NCT00817414|EG003|Reported Event|Cohort B1: LCI699 2.0 mg QD|Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
10952292|NCT00817414|EG004|Reported Event|Placebo|Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks.
10952293|NCT00817479|BG000|Baseline|Placebo|Placebo [saline]
10952294|NCT00817479|BG001|Baseline|Dexamethasone|20 mg dexamethasone IV push
10952295|NCT00817479|BG002|Baseline|Total|Total of all reporting groups
10952296|NCT00817479|FG000|Participant Flow|Placebo|Placebo [saline]
10952297|NCT00817479|FG001|Participant Flow|Dexamethasone|20 mg dexamethasone IV push
10952298|NCT00817479|OG000|Outcome|Placebo|Placebo [saline]
10952299|NCT00817479|OG001|Outcome|Dexamethasone|20 mg dexamethasone IV push
10952300|NCT00817479|EG000|Reported Event|Placebo|Placebo [saline]
10952301|NCT00817479|EG001|Reported Event|Dexamethasone|20 mg dexamethasone IV push
10952302|NCT00817531|BG000|Baseline|Dasatinib|Patients took Dasatinib 100mg daily
10952303|NCT00817531|FG000|Participant Flow|Dasatinib|Patients took Dasatinib 100mg daily
10952304|NCT00817531|OG000|Outcome|Dasatinib|Dasatinib 100 mg once daily
10952305|NCT00817531|EG000|Reported Event|Dasatinib|Patients took Dasatinib 100mg daily
10952306|NCT00817596|BG000|Baseline|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
10952307|NCT00817596|FG000|Participant Flow|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
10952308|NCT00817596|OG000|Outcome|Group 1|Prometra Intrathecal Pump System
10952309|NCT00817596|EG000|Reported Event|Group 1|Prometra Intrathecal Pump System
10952310|NCT00817635|BG000|Baseline|LCI699 0.25 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
10952311|NCT00817635|BG001|Baseline|LCI699 1 mg QD|Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
10952312|NCT00817635|BG002|Baseline|LCI699 0.5 mg Followed by LCI699 1 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
10952313|NCT00817635|BG003|Baseline|Eplerenone 50 mg BID|Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
10952314|NCT00817635|BG004|Baseline|Placebo|For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
10952315|NCT00817635|BG005|Baseline|Total|Total of all reporting groups
10952316|NCT00817635|FG000|Participant Flow|LCI699 0.25 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
10952317|NCT00817635|FG001|Participant Flow|LCI699 1 mg QD|Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
10952318|NCT00817635|FG002|Participant Flow|LCI699 0.5 mg Followed by LCI699 1 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
10952319|NCT00817635|FG003|Participant Flow|Eplerenone 50 mg BID|Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
10952320|NCT00817635|FG004|Participant Flow|Placebo|For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
10952321|NCT00817635|OG000|Outcome|LCI699 0.25 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
10952322|NCT00817635|OG001|Outcome|LCI699 1 mg QD|Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
10952323|NCT00817635|OG002|Outcome|LCI699 0.5 mg Followed by LCI699 1 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
10952324|NCT00817635|OG003|Outcome|Eplerenone 50 mg BID|Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
10952325|NCT00817635|OG004|Outcome|Placebo|For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
10952326|NCT00817635|OG000|Outcome|LCI699 0.25 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.25 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
10952327|NCT00817635|OG001|Outcome|LCI699 1 mg QD|Following a 2-week placebo run-in period, participants received LCI699 1 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.
10952328|NCT00817635|OG002|Outcome|LCI699 0.5 mg Followed by LCI699 1 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg capsules, orally, BID, with or without food for up to 4 weeks.
10952329|NCT00817635|OG003|Outcome|Eplerenone 50 mg BID|Following a 2-week placebo run-in period, participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
10952330|NCT00817635|OG000|Outcome|LCI699 0.25 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks
11178443|NCT02047227|EG000|Reported Event|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.
10952331|NCT00817635|OG000|Outcome|LCI699 1 mg QD|Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
10952332|NCT00817635|OG001|Outcome|LCI699 0.5 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks.
10952333|NCT00817635|EG000|Reported Event|LCI699 0.25 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
10952334|NCT00817635|EG001|Reported Event|LCI699 1.0 mg QD|Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
10952335|NCT00817635|EG002|Reported Event|LCI699 0.5 mg Followed by LCI699 1 mg BID|Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
10952336|NCT00817635|EG003|Reported Event|Eplerenone 50 mg BID|Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
10952337|NCT00817635|EG004|Reported Event|Placebo|For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
10952338|NCT00817778|BG000|Baseline|Experimental|AZD1656
10952339|NCT00817778|BG001|Baseline|Placebo Comparator|Placebo
10952340|NCT00817778|BG002|Baseline|Total|Total of all reporting groups
10952341|NCT00817778|FG000|Participant Flow|Experimental|AZD1656
10952342|NCT00817778|FG001|Participant Flow|Placebo Comparator|Placebo
10952343|NCT00817778|OG000|Outcome|Experimental|AZD1656
10952344|NCT00817778|OG001|Outcome|Placebo Comparator|Placebo
10952345|NCT00817778|EG000|Reported Event|Experimental|AZD1656
10952346|NCT00817778|EG001|Reported Event|Placebo Comparator|Placebo
10952347|NCT00817804|BG000|Baseline|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
10952348|NCT00817804|BG001|Baseline|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
10952349|NCT00817804|BG002|Baseline|Total|Total of all reporting groups
10952350|NCT00817804|FG000|Participant Flow|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
10952351|NCT00817804|FG001|Participant Flow|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
10952352|NCT00817804|OG000|Outcome|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
10952353|NCT00817804|OG001|Outcome|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
10952354|NCT00817804|EG000|Reported Event|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
10952355|NCT00817804|EG001|Reported Event|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
10952356|NCT00817843|BG000|Baseline|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
10952357|NCT00817843|FG000|Participant Flow|Simvastatin 80mg First, Then Simvastatin/Ezetimibe 10/10mg|First 6 weeks of treatment with simvastatin 80 mg with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin/ezetimibe 10/10 mg combination and placebo
10952358|NCT00817843|FG001|Participant Flow|Simvastatin/Ezetimibe 10/10mg First, Then Simvastatin 80mg|First 6 weeks of treatment with simvastatin/ezetimibe 10/10 mg combination with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin 80 mg and placebo
10952359|NCT00817843|OG000|Outcome|Simvastatin 80 mg|6 weeks of treatment with simvastatin 80 mg
10952360|NCT00817843|OG001|Outcome|Simvastatin 10 mg / Ezetimibe 10 mg|6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg
10952361|NCT00817843|EG000|Reported Event|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
10952362|NCT00817999|BG000|Baseline|Loading Dose|
10952363|NCT00817999|BG001|Baseline|Maintenance Dose|
10952364|NCT00817999|BG002|Baseline|Total|Total of all reporting groups
10952365|NCT00817999|FG000|Participant Flow|Loading Dose|Healthy volunteers who received a 300 mg dose of clopidogrel with or without grapefruit juice.
11178444|NCT02047227|EG001|Reported Event|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.
10952366|NCT00817999|FG001|Participant Flow|Maintenance Dose|Healthy volunteers who received clopidogrel 75 mg/day for 7 days during each period with or without grapefruit juice.
10952367|NCT00817999|OG000|Outcome|Loading Dose With Grapefruit Juice|
10952368|NCT00817999|OG001|Outcome|Maintenance Dose With Grapefruit Juice|
10952369|NCT00817999|OG002|Outcome|Loading Dose Without Grapefruit Juice|
10952370|NCT00817999|OG003|Outcome|Maintenance Dose Without Grapefruit Juice|
10952371|NCT00817999|EG000|Reported Event|Loading Dose|
11192274|NCT02138097|EG001|Reported Event|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
11192275|NCT02138097|EG002|Reported Event|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
10952372|NCT00817999|EG001|Reported Event|Maintenance Dose|
10952373|NCT00818116|BG000|Baseline|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
10952374|NCT00818116|FG000|Participant Flow|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
10952375|NCT00818116|OG000|Outcome|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
10952376|NCT00818116|EG000|Reported Event|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
10963665|NCT00873119|OG000|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
10963666|NCT00873119|OG001|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
10963667|NCT00873119|EG000|Reported Event|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
10963668|NCT00873119|EG001|Reported Event|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
10963669|NCT00873327|BG000|Baseline|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
10963670|NCT00873327|FG000|Participant Flow|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days postnatal age (PNA) 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation (GA) at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
10963671|NCT00873327|OG000|Outcome|PK Analysis Cohort - Piperacillin Plasma Clearance|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
10963672|NCT00873327|EG000|Reported Event|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
10963673|NCT00873457|BG000|Baseline|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
10963674|NCT00873457|FG000|Participant Flow|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
10963675|NCT00873457|OG000|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
10952377|NCT00818168|BG000|Baseline|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
10952378|NCT00818168|FG000|Participant Flow|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
10952379|NCT00818168|OG000|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
10952380|NCT00818168|EG000|Reported Event|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
10952381|NCT00818207|BG000|Baseline|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
10952382|NCT00818207|BG001|Baseline|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
10952383|NCT00818207|BG002|Baseline|Total|Total of all reporting groups
10952384|NCT00818207|FG000|Participant Flow|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
10952385|NCT00818207|FG001|Participant Flow|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
10952386|NCT00818207|OG000|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
10952387|NCT00818207|OG001|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
10952388|NCT00818207|EG000|Reported Event|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
10952389|NCT00818207|EG001|Reported Event|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
10952390|NCT00818246|BG000|Baseline|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
10952391|NCT00818246|FG000|Participant Flow|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
10952392|NCT00818246|OG000|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
10952393|NCT00818246|EG000|Reported Event|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
10952394|NCT00818259|BG000|Baseline|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952395|NCT00818259|BG001|Baseline|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952396|NCT00818259|BG002|Baseline|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952397|NCT00818259|BG003|Baseline|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952398|NCT00818259|BG004|Baseline|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
10963676|NCT00873457|EG000|Reported Event|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
10963677|NCT00873730|BG000|Baseline|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
10963678|NCT00873730|BG001|Baseline|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
10963679|NCT00873730|BG002|Baseline|Total|Total of all reporting groups
10952399|NCT00818259|BG005|Baseline|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
10952400|NCT00818259|BG006|Baseline|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952401|NCT00818259|BG007|Baseline|Total|Total of all reporting groups
10952402|NCT00818259|FG000|Participant Flow|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952403|NCT00818259|FG001|Participant Flow|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952404|NCT00818259|FG002|Participant Flow|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952405|NCT00818259|FG003|Participant Flow|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952406|NCT00818259|FG004|Participant Flow|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
10952407|NCT00818259|FG005|Participant Flow|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
10952408|NCT00818259|FG006|Participant Flow|Part IV-Additional Enrollers|Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
10952409|NCT00818259|FG007|Participant Flow|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952410|NCT00818259|FG008|Participant Flow|Part V-Additional Enrollers|Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952411|NCT00818259|OG000|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952412|NCT00818259|OG001|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952413|NCT00818259|OG002|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952414|NCT00818259|OG003|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952415|NCT00818259|OG004|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
10963680|NCT00873730|FG000|Participant Flow|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
10963681|NCT00873730|FG001|Participant Flow|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
11192276|NCT02138097|EG003|Reported Event|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
11192277|NCT02138097|EG004|Reported Event|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
10952416|NCT00818259|OG005|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
10952417|NCT00818259|OG006|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952418|NCT00818259|EG000|Reported Event|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952419|NCT00818259|EG001|Reported Event|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952420|NCT00818259|EG002|Reported Event|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952421|NCT00818259|EG003|Reported Event|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952422|NCT00818259|EG004|Reported Event|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
10952423|NCT00818259|EG005|Reported Event|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
10952424|NCT00818259|EG006|Reported Event|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
10952425|NCT00818272|BG000|Baseline|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
10952426|NCT00818272|FG000|Participant Flow|Infliximab|Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
10952427|NCT00818272|OG000|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
10952428|NCT00818272|EG000|Reported Event|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
10952429|NCT00818324|BG000|Baseline|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
11192278|NCT02138097|EG005|Reported Event|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
10952430|NCT00818324|FG000|Participant Flow|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
10952431|NCT00818324|OG000|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
10952432|NCT00818324|EG000|Reported Event|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
10952433|NCT00818337|BG000|Baseline|Aspirin 81mg|Aspirin 81mg at baseline
10952434|NCT00818337|FG000|Participant Flow|Aspirin 81mg|Aspirin 81mg at baseline
10952435|NCT00818337|OG000|Outcome|Aspirin 81 mg|Aspirin 81 mg at baseline
10952436|NCT00818337|OG000|Outcome|Aspirin 325 mg|Participants who were aspirin resistant who were increased to aspirin 325 mg
10952437|NCT00818337|EG000|Reported Event|Aspirin 81mg|Aspirin 81mg at baseline
10952438|NCT00818363|BG000|Baseline|Group 1: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once"
10952439|NCT00818363|BG001|Baseline|Group 2: SABER-Placebo|"5.0 mL SABER-Placebo/Once~SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once"
10952440|NCT00818363|BG002|Baseline|Total|Total of all reporting groups
10952441|NCT00818363|FG000|Participant Flow|Group 1: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once"
10952442|NCT00818363|FG001|Participant Flow|Group 2: SABER-Placebo|"5.0 mL SABER-Placebo/Once~SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once"
10952443|NCT00818363|OG000|Outcome|Group 1: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once"
10952444|NCT00818363|OG001|Outcome|Group 2: SABER-Placebo|"5.0 mL SABER-Placebo/Once~SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once"
10952445|NCT00818363|EG000|Reported Event|Group 1: SABER-Bupivacaine|"5.0 mL SABER-Bupivacaine/Once~SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once"
10952446|NCT00818363|EG001|Reported Event|Group 2: SABER-Placebo|"5.0 mL SABER-Placebo/Once~SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once"
10952447|NCT00818389|BG000|Baseline|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
10952448|NCT00818389|BG001|Baseline|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
10952449|NCT00818389|BG002|Baseline|Total|Total of all reporting groups
10952450|NCT00818389|FG000|Participant Flow|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
11192279|NCT02138097|EG006|Reported Event|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
11192280|NCT02138097|EG007|Reported Event|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
10952451|NCT00818389|FG001|Participant Flow|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
10952452|NCT00818389|OG000|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
10952453|NCT00818389|OG001|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
10963682|NCT00873730|OG000|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
10963683|NCT00873730|OG001|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
10963684|NCT00873730|EG000|Reported Event|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
10963685|NCT00873730|EG001|Reported Event|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
11192281|NCT02138097|EG008|Reported Event|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
10952454|NCT00818389|EG000|Reported Event|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
10952455|NCT00818389|EG001|Reported Event|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
10952456|NCT00818441|BG000|Baseline|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
11192282|NCT02138097|EG009|Reported Event|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
11192283|NCT02138110|BG000|Baseline|Neuro-Spinal Scaffold|"Implantation of neuro-spinal scaffold in a cavity at the epicenter of the spinal cord contusion during open spine surgery.~Neuro-Spinal Scaffold"
11192284|NCT02138110|FG000|Participant Flow|Neuro-Spinal Scaffold|Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
11192285|NCT02138110|OG000|Outcome|Neuro-Spinal Scaffold|Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
11192286|NCT02138110|EG000|Reported Event|Neuro-Spinal Scaffold|Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
11192287|NCT02138136|BG000|Baseline|All Participants|Participants receive lubiprostone
11192288|NCT02138136|FG000|Participant Flow|All Participants|Participants received lubiprostone
11192289|NCT02138136|OG000|Outcome|All Participants|Participants received lubiprostone
11192290|NCT02138136|OG000|Outcome|All Participants|Participants receive lubiprostone
11192291|NCT02138136|EG000|Reported Event|All Participants|Participants receive lubiprostone
11192292|NCT02138214|BG000|Baseline|Arm I (no CND)|"Patients undergo total thyroidectomy alone.~Thyroidectomy: Undergo total thyroidectomy~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192293|NCT02138214|BG001|Baseline|Arm II (CND)|"Patients undergo total thyroidectomy with ipsilateral prophylactic CND.~Thyroidectomy: Undergo total thyroidectomy~Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192294|NCT02138214|BG002|Baseline|Arm III (SOC)|"Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192295|NCT02138214|BG003|Baseline|Total|Total of all reporting groups
11192296|NCT02138214|FG000|Participant Flow|Arm I (no CND)|"Patients undergo total thyroidectomy alone.~Thyroidectomy: Undergo total thyroidectomy~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192297|NCT02138214|FG001|Participant Flow|Arm II (CND)|"Patients undergo total thyroidectomy with ipsilateral prophylactic CND.~Thyroidectomy: Undergo total thyroidectomy~Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192298|NCT02138214|FG002|Participant Flow|Arm III (SOC)|"Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192299|NCT02138214|OG000|Outcome|Arm II (CND)|"Patients undergo total thyroidectomy with ipsilateral prophylactic CND.~Thyroidectomy: Undergo total thyroidectomy~Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192300|NCT02138214|OG001|Outcome|Arm I (no CND)|"Patients undergo total thyroidectomy alone.~Thyroidectomy: Undergo total thyroidectomy~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192301|NCT02138214|EG000|Reported Event|Arm I (no CND)|"Patients undergo total thyroidectomy alone.~Thyroidectomy: Undergo total thyroidectomy~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192302|NCT02138214|EG001|Reported Event|Arm II (CND)|"Patients undergo total thyroidectomy with ipsilateral prophylactic CND.~Thyroidectomy: Undergo total thyroidectomy~Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192303|NCT02138214|EG002|Reported Event|Arm III (SOC)|"Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference~Quality-of-life assessment: Voice evaluation, interviews, ancillary studies"
11192304|NCT02138227|BG000|Baseline|Assisted CEaD Condition|In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.
11192305|NCT02138227|BG001|Baseline|Autonomous CEaD Condition|In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.
11192306|NCT02138227|BG002|Baseline|Total|Total of all reporting groups
10952457|NCT00818441|BG001|Baseline|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
10952458|NCT00818441|BG002|Baseline|Total|Total of all reporting groups
10952459|NCT00818441|FG000|Participant Flow|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
10952460|NCT00818441|FG001|Participant Flow|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
10952461|NCT00818441|OG000|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
10952462|NCT00818441|OG000|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
10952463|NCT00818441|OG001|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
10952464|NCT00818441|EG000|Reported Event|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
10963686|NCT00873782|BG000|Baseline|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
10952465|NCT00818441|EG001|Reported Event|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
10952466|NCT00818454|BG000|Baseline|Entire Study Population|Participants randomized to crossover part at randomization 1
10952467|NCT00818454|FG000|Participant Flow|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
10952468|NCT00818454|FG001|Participant Flow|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
10952469|NCT00818454|FG002|Participant Flow|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
10952470|NCT00818454|FG003|Participant Flow|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
10952471|NCT00818454|OG000|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
10952472|NCT00818454|OG001|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
10952473|NCT00818454|OG000|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
10952474|NCT00818454|OG001|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
10952475|NCT00818454|EG000|Reported Event|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
10952476|NCT00818454|EG001|Reported Event|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
10952477|NCT00818454|EG002|Reported Event|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
10952478|NCT00818454|EG003|Reported Event|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
10952479|NCT00818519|BG000|Baseline|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
10952480|NCT00818519|BG001|Baseline|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
10952481|NCT00818519|BG002|Baseline|Total|Total of all reporting groups
10952482|NCT00818519|FG000|Participant Flow|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
10952483|NCT00818519|FG001|Participant Flow|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
10952484|NCT00818519|OG000|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
10952485|NCT00818519|OG001|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
10952486|NCT00818519|EG000|Reported Event|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
10952487|NCT00818519|EG001|Reported Event|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
10952488|NCT00818623|BG000|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
10952489|NCT00818623|BG001|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
10952490|NCT00818623|BG002|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
10952491|NCT00818623|BG003|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
10952492|NCT00818623|BG004|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
10952493|NCT00818623|BG005|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
10952494|NCT00818623|BG006|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
10952495|NCT00818623|BG007|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
10952496|NCT00818623|BG008|Baseline|Total|Total of all reporting groups
10952497|NCT00818623|FG000|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
10952498|NCT00818623|FG001|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
10952499|NCT00818623|FG002|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
10952500|NCT00818623|FG003|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
10952501|NCT00818623|FG004|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
10952502|NCT00818623|FG005|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
10952503|NCT00818623|FG006|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
10952504|NCT00818623|FG007|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
10952505|NCT00818623|OG000|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
10952506|NCT00818623|OG001|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
10952507|NCT00818623|OG002|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
10952508|NCT00818623|OG003|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
10952509|NCT00818623|OG004|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
10952510|NCT00818623|OG005|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
10952511|NCT00818623|OG006|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
10952512|NCT00818623|OG007|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
10952513|NCT00818623|EG000|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
10952514|NCT00818623|EG001|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
10952515|NCT00818623|EG002|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
10952516|NCT00818623|EG003|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
10952517|NCT00818623|EG004|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
10952518|NCT00818623|EG005|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
10952519|NCT00818623|EG006|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
10952520|NCT00818623|EG007|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
10952521|NCT00818649|BG000|Baseline|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
10952522|NCT00818649|FG000|Participant Flow|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
10952523|NCT00818649|OG000|Outcome|Evaluable Patients|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment continued for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
10952524|NCT00818649|OG000|Outcome|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
10952525|NCT00818649|EG000|Reported Event|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
11178445|NCT02047253|BG000|Baseline|Carfilzomib|"Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.~Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.~Dexamethasone: Administered prior to administration of Study drug~Acyclovir: Administered orally twice daily"
10952526|NCT00818662|BG000|Baseline|IGIV, 10% 400mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
10952527|NCT00818662|BG001|Baseline|IGIV, 10% 200mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
10952528|NCT00818662|BG002|Baseline|Placebo 4 mL/kg|0.25% human albumin solution infused at 4 mL/kg/2weeks Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks
10952529|NCT00818662|BG003|Baseline|Placebo 2 mL/kg|0.25% human albumin solution infused at 2 mL/kg/2weeks Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks
10952530|NCT00818662|BG004|Baseline|Total|Total of all reporting groups
10952531|NCT00818662|FG000|Participant Flow|IGIV, 10% 400mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
10952532|NCT00818662|FG001|Participant Flow|IGIV, 10% 200mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
10952533|NCT00818662|FG002|Participant Flow|Placebo 4 mL/kg|0.25% human albumin solution infused at 4 mL/kg/2weeks Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks
10952534|NCT00818662|FG003|Participant Flow|Placebo 2 mL/kg|0.25% human albumin solution infused at 2 mL/kg/2weeks Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks
10952535|NCT00818662|OG000|Outcome|IGIV, 10% 400mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
10952536|NCT00818662|OG001|Outcome|IGIV, 10% 200mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
10952537|NCT00818662|OG002|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
10952538|NCT00818662|OG000|Outcome|IGIV, 10% 400mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
10952539|NCT00818662|OG001|Outcome|IGIV, 10% 200mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
10952540|NCT00818662|OG002|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
10952541|NCT00818662|EG000|Reported Event|IGIV, 10% 400mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
10952542|NCT00818662|EG001|Reported Event|IGIV, 10% 200mg/kg|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
10952543|NCT00818662|EG002|Reported Event|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2weeks for 70 weeks Adverse Events That Occurred During or After Treatment
10952544|NCT00818753|BG000|Baseline|Dabigatran 110mg Bis in Die (BID)|
10952545|NCT00818753|BG001|Baseline|Dabigatran 150mg Bis in Die (BID)|
10952546|NCT00818753|BG002|Baseline|Heparin|Unfractionated heparin administered during intervention
10952547|NCT00818753|BG003|Baseline|Total|Total of all reporting groups
10952548|NCT00818753|FG000|Participant Flow|Dabigatran 110mg Bis in Die (BID)|
10952549|NCT00818753|FG001|Participant Flow|Dabigatran 150mg Bis in Die (BID)|
10952550|NCT00818753|FG002|Participant Flow|Heparin|Unfractionated heparin administered during intervention
10952551|NCT00818753|OG000|Outcome|Dabigatran 110mg Bis in Die (BID)|
10952552|NCT00818753|OG001|Outcome|Dabigatran 150mg Bis in Die (BID)|
10952553|NCT00818753|OG002|Outcome|Heparin|Unfractionated heparin administered during intervention
10952554|NCT00818753|EG000|Reported Event|Dabigatran 110mg Bis in Die (BID)|
10952555|NCT00818753|EG001|Reported Event|Dabigatran 150mg Bis in Die (BID)|
10952556|NCT00818753|EG002|Reported Event|Heparin|Unfractionated heparin administered during intervention
10952557|NCT00818766|BG000|Baseline|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
10952558|NCT00818766|BG001|Baseline|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
10952559|NCT00818766|BG002|Baseline|Total|Total of all reporting groups
10952560|NCT00818766|FG000|Participant Flow|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
10952561|NCT00818766|FG001|Participant Flow|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
10952562|NCT00818766|OG000|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
10952563|NCT00818766|OG001|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
10952564|NCT00818766|EG000|Reported Event|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
10952565|NCT00818766|EG001|Reported Event|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
10952566|NCT00818779|BG000|Baseline|Aliskiren|Aliskiren 150-300 mg once daily
10952567|NCT00818779|BG001|Baseline|Amlodipine|5-10 mg amlodipine once daily
10952568|NCT00818779|BG002|Baseline|Total|Total of all reporting groups
10952569|NCT00818779|FG000|Participant Flow|Aliskiren|Aliskiren 150-300 mg once daily
10952570|NCT00818779|FG001|Participant Flow|Amlodipine|5-10 mg amlodipine once daily
10952571|NCT00818779|OG000|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
10952572|NCT00818779|OG001|Outcome|Amlodipine|5-10 mg amlodipine once daily
10952573|NCT00818779|EG000|Reported Event|Aliskiren|Aliskiren 150-300 mg once daily
10952574|NCT00818779|EG001|Reported Event|Amlodipine|5-10 mg amlodipine once daily
10952575|NCT00818805|BG000|Baseline|Entire Study Population|
10952576|NCT00818805|FG000|Participant Flow|Olopatadine 0.1% First, Then Tranilast Second|Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next
10952577|NCT00818805|FG001|Participant Flow|Tranilast 0.5% First, Then Olopatadine Second|Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last.
10952578|NCT00818805|OG000|Outcome|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
10952579|NCT00818805|OG001|Outcome|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
10952580|NCT00818805|OG002|Outcome|Placebo (Olopatadine)|Placebo (Olopatadine) in one eye in either the first or second period
10952581|NCT00818805|OG003|Outcome|Placebo (Tranilast)|Placebo (Tranilast) in one eye in either the first or second period
10952582|NCT00818805|EG000|Reported Event|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
10952583|NCT00818805|EG001|Reported Event|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
10952584|NCT00818805|EG002|Reported Event|Placebo (Olopatadine) One Eye|Placebo (Olopatadine) in one eye in either the first or second period
10952585|NCT00818805|EG003|Reported Event|Placebo (Tranilast) One Eye|Placebo (Tranilast) in one eye in either the first or second period
10952586|NCT00818883|BG000|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
10952587|NCT00818883|BG001|Baseline|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
10952588|NCT00818883|BG002|Baseline|Total|Total of all reporting groups
11178446|NCT02047253|FG000|Participant Flow|Carfilzomib|"Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.~Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.~Dexamethasone: Administered prior to administration of Study drug~Acyclovir: Administered orally twice daily"
10952589|NCT00818883|FG000|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
10952590|NCT00818883|FG001|Participant Flow|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
10952591|NCT00818883|OG000|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
10952592|NCT00818883|OG001|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
10952593|NCT00818883|EG000|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
10952594|NCT00818883|EG001|Reported Event|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
10952595|NCT00818961|BG000|Baseline|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
10952596|NCT00818961|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
10952597|NCT00818961|OG000|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
10952598|NCT00818961|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|All patients received a hematopoietic Stem Cell Transplantation as part of this clinical trial.
10952599|NCT00819013|BG000|Baseline|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
10952600|NCT00819013|BG001|Baseline|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
10952601|NCT00819013|BG002|Baseline|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
10952602|NCT00819013|BG003|Baseline|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
10952603|NCT00819013|BG004|Baseline|Total|Total of all reporting groups
10952604|NCT00819013|FG000|Participant Flow|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
10952605|NCT00819013|FG001|Participant Flow|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
10952606|NCT00819013|FG002|Participant Flow|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
10952607|NCT00819013|FG003|Participant Flow|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
10952608|NCT00819013|OG000|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
10952609|NCT00819013|OG001|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
10952610|NCT00819013|OG002|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
10952611|NCT00819013|OG003|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
10952612|NCT00819013|EG000|Reported Event|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
10952613|NCT00819013|EG001|Reported Event|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
10952614|NCT00819013|EG002|Reported Event|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
10952615|NCT00819013|EG003|Reported Event|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
10952616|NCT00819039|BG000|Baseline|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
11178447|NCT02047253|OG000|Outcome|Carfilzomib|"Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.~Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.~Dexamethasone: Administered prior to administration of Study drug~Acyclovir: Administered orally twice daily"
10952617|NCT00819039|BG001|Baseline|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952618|NCT00819039|BG002|Baseline|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952619|NCT00819039|BG003|Baseline|Total|Total of all reporting groups
10952620|NCT00819039|FG000|Participant Flow|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952621|NCT00819039|FG001|Participant Flow|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952622|NCT00819039|FG002|Participant Flow|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952623|NCT00819039|OG000|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952624|NCT00819039|OG001|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952625|NCT00819039|OG002|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952626|NCT00819039|OG000|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
10952627|NCT00819039|OG001|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952628|NCT00819039|EG000|Reported Event|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952629|NCT00819039|EG001|Reported Event|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952630|NCT00819039|EG002|Reported Event|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
10952631|NCT00819052|BG000|Baseline|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
10952632|NCT00819052|BG001|Baseline|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
10952633|NCT00819052|BG002|Baseline|Total|Total of all reporting groups
10952634|NCT00819052|FG000|Participant Flow|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
10952635|NCT00819052|FG001|Participant Flow|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
10952636|NCT00819052|OG000|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
10952637|NCT00819052|OG001|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
10952638|NCT00819052|OG000|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
10952639|NCT00819052|OG001|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
10952640|NCT00819052|OG002|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
10952641|NCT00819052|EG000|Reported Event|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
10952642|NCT00819052|EG001|Reported Event|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
10952643|NCT00819091|BG000|Baseline|Placebo|Matching placebo tablet taken orally once daily
10952644|NCT00819091|BG001|Baseline|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
10952645|NCT00819091|BG002|Baseline|Total|Total of all reporting groups
10952646|NCT00819091|FG000|Participant Flow|Placebo|Matching placebo tablet taken orally once daily
10952647|NCT00819091|FG001|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
10952648|NCT00819091|OG000|Outcome|Placebo|Matching placebo tablet taken orally once daily
10952649|NCT00819091|OG001|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
10952650|NCT00819091|EG000|Reported Event|Placebo|Matching placebo tablet taken orally once daily
10952651|NCT00819091|EG001|Reported Event|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
10952652|NCT00819156|BG000|Baseline|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952653|NCT00819156|BG001|Baseline|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952654|NCT00819156|BG002|Baseline|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952655|NCT00819156|BG003|Baseline|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952656|NCT00819156|BG004|Baseline|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952657|NCT00819156|BG005|Baseline|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952658|NCT00819156|BG006|Baseline|Total|Total of all reporting groups
10952659|NCT00819156|FG000|Participant Flow|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952660|NCT00819156|FG001|Participant Flow|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952661|NCT00819156|FG002|Participant Flow|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952662|NCT00819156|FG003|Participant Flow|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952663|NCT00819156|FG004|Participant Flow|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952664|NCT00819156|FG005|Participant Flow|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952665|NCT00819156|OG000|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952666|NCT00819156|OG001|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952667|NCT00819156|OG002|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952668|NCT00819156|OG003|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952669|NCT00819156|OG004|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952670|NCT00819156|OG005|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952671|NCT00819156|OG000|Outcome|Maintenance Dose of 80 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 80 milligram per cycle in cycles 2-13 have been combined.
10952672|NCT00819156|OG001|Outcome|Maintenance Dose of 120 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 120 milligram per cycle in cycles 2-13 have been combined.
10952673|NCT00819156|OG002|Outcome|Maintenance Dose of 160 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 160 milligram per cycle in cycles 2-13 have been combined.
10952674|NCT00819156|OG000|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952675|NCT00819156|OG001|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952676|NCT00819156|OG002|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952677|NCT00819156|OG003|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952678|NCT00819156|OG004|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952679|NCT00819156|EG000|Reported Event|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952680|NCT00819156|EG001|Reported Event|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952681|NCT00819156|EG002|Reported Event|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952682|NCT00819156|EG003|Reported Event|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
10952683|NCT00819156|EG004|Reported Event|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
10952684|NCT00819156|EG005|Reported Event|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
10952685|NCT00819182|BG000|Baseline|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
10952686|NCT00819182|BG001|Baseline|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
10952687|NCT00819182|BG002|Baseline|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
10952688|NCT00819182|BG003|Baseline|Total|Total of all reporting groups
10952689|NCT00819182|FG000|Participant Flow|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
10952690|NCT00819182|FG001|Participant Flow|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
10952691|NCT00819182|FG002|Participant Flow|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
10952692|NCT00819182|OG000|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
10952693|NCT00819182|OG001|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
10952694|NCT00819182|OG002|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
10952695|NCT00819182|EG000|Reported Event|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
10952696|NCT00819182|EG001|Reported Event|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
11178448|NCT02047253|EG000|Reported Event|Carfilzomib|"Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.~Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.~Dexamethasone: Administered prior to administration of Study drug~Acyclovir: Administered orally twice daily"
11178449|NCT02047305|BG000|Baseline|Radiofrequency Ablation|"To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN~Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals."
11178450|NCT02047305|FG000|Participant Flow|Radiofrequency Ablation|"To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN~Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals."
11178451|NCT02047305|OG000|Outcome|Radiofrequency Ablation|"To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN~Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals."
11178452|NCT02047305|EG000|Reported Event|Radiofrequency Ablation|"To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN~Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals."
11178453|NCT02047318|BG000|Baseline|Core Study Period|In the lead-in Study LUM001-302, participants were randomized to receive either placebo or active drug (MRX). The last observation obtained before first dose of MRX (either for participants who received MRX in Study LUM001-302 or in Study LUM001-303 for participants who received placebo in Study LUM001-302) was used as the MRX baseline observation for all calculations of change from MRX baseline. For participants who were assigned MRX in Study LUM001-302, results at each post-baseline analysis visit included up to 13 more weeks of treatment than participants who were assigned placebo in Study LUM001-302. The core study period of Study LUM001-303 was from Day 1 to Week 72. It encompassed: - a 4-week double-blind dose-escalation period - an 8-week dose-optimization period - a 60-week stable dosing period. Participants could consent to continued long-term follow-up. The furthest analysis timepoint reached by any participant was Week 336. All participants received MRX.
11178454|NCT02047318|FG000|Participant Flow|LUM001 (Maralixibat)|LUM001 also known as Maralixibat (MRX) administered orally up to twice each day
11178455|NCT02047318|OG000|Outcome|Core Study Period: MRX Baseline Values|These are the MRX baseline values for participants. The last observation obtained before the first dose of MRX (whether before receiving MRX in Study LUM001-302 for participants who received MRX in Study LUM001-302, or in Study LUM001-303 for participants who received placebo in Study LUM001-302) was used as the MRX baseline observation for all calculations of change from MRX baseline. For participants who were assigned MRX in Study LUM001-302, results at each post-baseline analysis visit included up to 13 more weeks of treatment than participants who were assigned placebo in Study LUM001-302.
11178456|NCT02047318|OG001|Outcome|Core Study Period: Week 48 Values|These are the Week 48 values for participants. These participants are also represented in the Core study period: MRX baseline values group; the analyses look at the change from MRX baseline to Week 48 in the same participants.
11178457|NCT02047318|OG000|Outcome|Core Study Period: MRX Baseline Value|These are the MRX baseline values for participants. The last observation obtained before the first dose of MRX (whether before receiving MRX in Study LUM001-302 for participants who received MRX in Study LUM001-302, or in Study LUM001-303 for participants who received placebo in Study LUM001-302) was used as the MRX baseline observation for all calculations of change from MRX baseline. For participants who were assigned MRX in Study LUM001-302, results at each post-baseline analysis visit included up to 13 more weeks of treatment than participants who were assigned placebo in Study LUM001-302.
11178458|NCT02047318|OG001|Outcome|Week 252 Values|Week 252 values for participants continuing in the study. These participants are also represented in the Core study period: MRX baseline values group; the analyses look at the change from MRX baseline to Week 252 in the same participants.
11178459|NCT02047318|OG001|Outcome|Week 278 Values|Week 278 values for participants continuing in the study.
11178460|NCT02047318|EG000|Reported Event|14 Microgram Per Kilogram Per Day (mcg/kg/Day)|Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated starting at 14 microgram per kilogram per day (mcg/kg/day) for one week. This reporting group includes the period of time that participants received 14 mcg/kg/day.
11178461|NCT02047318|EG001|Reported Event|35 Microgram Per Kilogram Per Day (mcg/kg/Day)|Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 14 to 35 for one week. This reporting group includes the period of time that participants received 35 mcg/kg/day.
11178462|NCT02047318|EG002|Reported Event|70 Microgram Per Kilogram Per Day (mcg/kg/Day)|Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 35 to 70 microgram per kilogram per day (mcg/kg/day) for one week. This reporting group includes the period of time that participants received 70 mcg/kg/day.
11178463|NCT02047318|EG003|Reported Event|140 Microgram Per Kilogram Per Day (mcg/kg/Day)|Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 70 to 140 microgram per kilogram per day (mcg/kg/day) for one week. This reporting group includes the period of time that participants received 140 mcg/kg/day.
10952697|NCT00819182|EG002|Reported Event|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
10952698|NCT00819234|BG000|Baseline|All Participants|All participants who completed the original study and chose to enter the extension study.
10952699|NCT00819234|FG000|Participant Flow|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952700|NCT00819234|FG001|Participant Flow|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952701|NCT00819234|FG002|Participant Flow|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952702|NCT00819234|FG003|Participant Flow|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
11234314|NCT02433665|EG001|Reported Event|Customized Dose|"100 of the first 200 subjects will be randomized to a customized dose of contrast material based on the experimental algorithm. The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm.~Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).~Mydose: 400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters."
11234315|NCT02433678|BG000|Baseline|Placebo|"Patients will be treated for 12 weeks with placebo once daily~Placebo"
11234316|NCT02433678|BG001|Baseline|Dapagliflozin|"10 mg daily for the 12 weeks~dapagliflozin: SGLT-2 inhibitor for the treatment of type 2 diabetes"
11234317|NCT02433678|BG002|Baseline|Total|Total of all reporting groups
11234318|NCT02433678|FG000|Participant Flow|Placebo|"Patients will be treated for 12 weeks with placebo once daily~Placebo"
11234319|NCT02433678|FG001|Participant Flow|Dapagliflozin|"10 mg daily for the 12 weeks~dapagliflozin: SGLT-2 inhibitor for the treatment of type 2 diabetes"
10952703|NCT00819234|FG004|Participant Flow|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
10952704|NCT00819234|FG005|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
10952705|NCT00819234|FG006|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
10952706|NCT00819234|FG007|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
11234320|NCT02433678|OG000|Outcome|Placebo|"Patients will be treated for 12 weeks with placebo once daily~Placebo"
11234321|NCT02433678|OG001|Outcome|Dapagliflozin|"10 mg daily for the 12 weeks~dapagliflozin: SGLT-2 inhibitor for the treatment of type 2 diabetes"
11234322|NCT02433678|EG000|Reported Event|Placebo|"Patients will be treated for 12 weeks with placebo once daily~Placebo"
11234323|NCT02433678|EG001|Reported Event|Dapagliflozin|"10 mg daily for the 12 weeks~dapagliflozin: SGLT-2 inhibitor for the treatment of type 2 diabetes"
11234324|NCT02433834|BG000|Baseline|Overall Study|All patients randomized
11234325|NCT02433834|FG000|Participant Flow|Overall Study|All patients randomized
11234326|NCT02433834|OG000|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
11234327|NCT02433834|OG001|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
11234328|NCT02433834|OG002|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
11234329|NCT02433834|OG003|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
11234330|NCT02433834|OG004|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
11234331|NCT02433834|OG005|Outcome|Placebo MDI|Placebo MDI.
10952707|NCT00819234|FG008|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952708|NCT00819234|FG009|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952709|NCT00819234|OG000|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952710|NCT00819234|OG001|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
10952711|NCT00819234|OG002|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
10952712|NCT00819234|OG003|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
11178464|NCT02047318|EG004|Reported Event|280 Microgram Per Kilogram Per Day (mcg/kg/Day)|Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 140 to 280 microgram per kilogram per day (mcg/kg/day) for 8-week dose optimization period and during the stable dosing period for up to 124 weeks. Participants who received MRX in the predecessor study LUM001-302 started on their dose from Week 13 of that study (280 mcg/kg/day or highest tolerated dose). This reporting group includes the period of time that participants received 280 mcg/kg/day.
11178465|NCT02047318|EG005|Reported Event|420 Microgram Per Kilogram Per Day (mcg/kg/Day)|Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Based on efficacy and safety assessments, participants could receive BID dosing after week 136, starting at 420 microgram per kilogram per day (mcg/kg/day) for 4-week dose escalation period. This reporting group includes the period of time that participants received 420 mcg/kg/day.
11178466|NCT02047318|EG006|Reported Event|560 Microgram Per Kilogram Per Day (mcg/kg/Day)|Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants on BID dosing could have their dose escalated from 480 to 560 microgram per kilogram per day (mcg/kg/day) for the remainder of the study. This reporting group includes the period of time that participants received 560 mcg/kg/day.
10952713|NCT00819234|OG001|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
10952714|NCT00819234|OG002|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
10952715|NCT00819234|OG000|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
10952716|NCT00819234|OG001|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
10952717|NCT00819234|OG002|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
10952718|NCT00819234|OG000|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
10952719|NCT00819234|OG001|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
10952720|NCT00819234|OG002|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
10952721|NCT00819234|OG003|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
10952722|NCT00819234|OG000|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
10952723|NCT00819234|OG001|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952724|NCT00819234|OG002|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
11234332|NCT02433834|OG006|Outcome|SAL 50 µg|salmeterol 50 µg
11234333|NCT02433834|EG000|Reported Event|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
10952725|NCT00819234|OG003|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952726|NCT00819234|OG004|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952727|NCT00819234|OG005|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952728|NCT00819234|OG006|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952729|NCT00819234|OG007|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed, to minimize nausea and/or vomiting.
10952730|NCT00819234|OG008|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952731|NCT00819234|OG009|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952732|NCT00819234|OG002|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952733|NCT00819234|OG003|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952734|NCT00819234|OG007|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952735|NCT00819234|OG000|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952736|NCT00819234|OG001|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952737|NCT00819234|OG007|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952738|NCT00819234|OG000|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952739|NCT00819234|OG001|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952740|NCT00819234|OG002|Outcome|Pramlintide 360 Mcg + Metreleptin 5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952741|NCT00819234|OG001|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952742|NCT00819234|OG002|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952743|NCT00819234|OG003|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952744|NCT00819234|OG009|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
11234334|NCT02433834|EG001|Reported Event|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
11234335|NCT02433834|EG002|Reported Event|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
11234336|NCT02433834|EG003|Reported Event|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
10952745|NCT00819234|OG008|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952746|NCT00819234|OG000|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952747|NCT00819234|OG001|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952748|NCT00819234|OG002|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952749|NCT00819234|OG003|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952750|NCT00819234|OG004|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952751|NCT00819234|OG005|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952752|NCT00819234|EG000|Reported Event|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
10952753|NCT00819234|EG001|Reported Event|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952754|NCT00819234|EG002|Reported Event|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952755|NCT00819234|EG003|Reported Event|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
10952756|NCT00819234|EG004|Reported Event|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952757|NCT00819234|EG005|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952758|NCT00819234|EG006|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
10952759|NCT00819234|EG007|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952760|NCT00819234|EG008|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952761|NCT00819234|EG009|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
10952762|NCT00819247|BG000|Baseline|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
10952763|NCT00819247|BG001|Baseline|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
10952764|NCT00819247|BG002|Baseline|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
10952765|NCT00819247|BG003|Baseline|Total|Total of all reporting groups
10952766|NCT00819247|FG000|Participant Flow|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
10952767|NCT00819247|FG001|Participant Flow|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
10952768|NCT00819247|FG002|Participant Flow|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
10952769|NCT00819247|OG000|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
10952770|NCT00819247|OG001|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
10952771|NCT00819247|OG002|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
11178467|NCT02047318|EG007|Reported Event|LUM001 MRX Treatment|Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 14, 35, 70, and 140 microgram per kilogram per day (mcg/kg/day) for 4-week dose escalation period. Participants who received maralixibat during study LUM001-302, underwent a mock dose escalation and remained on the dose received at the end of study LUM001-302. During 8-weeks of dose optimization period, drug was adjusted in titrated manner up to 280 mcg/kg/day or highest tolerated dose and dosing was continued to complete the stable dosing and safety monitoring periods for up to 136 weeks of cumulative MRX exposure in this study at this dose level. In the long-term extension, participants could receive BID dosing up to 560 mcg/kg/day for the remainder of the study for up to 336 weeks of cumulative MRX exposure in this study. This reporting group includes all doses of MRX.
11178468|NCT02047344|BG000|Baseline|K-Ras Negative|Fresh or archival biopsy tissue to determine KRAS is not mutant. Patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression.
10952772|NCT00819247|EG000|Reported Event|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
10952773|NCT00819247|EG001|Reported Event|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
10952774|NCT00819247|EG002|Reported Event|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
10952775|NCT00819260|BG000|Baseline|All Participants|Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.
10952776|NCT00819260|FG000|Participant Flow|All Participants|All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.
10952777|NCT00819260|OG000|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
10952778|NCT00819260|OG001|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
10952779|NCT00819260|EG000|Reported Event|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
11234337|NCT02433834|EG004|Reported Event|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
10952780|NCT00819260|EG001|Reported Event|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
10952781|NCT00819286|BG000|Baseline|Wire (Control)|patients will have their sternum closed using stainless steel wires.
10952782|NCT00819286|BG001|Baseline|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
10952783|NCT00819286|BG002|Baseline|Total|Total of all reporting groups
10952784|NCT00819286|FG000|Participant Flow|Wire (Control)|patients will have their sternum closed using stainless steel wires.
10952785|NCT00819286|FG001|Participant Flow|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
10952786|NCT00819286|OG000|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
10952787|NCT00819286|OG001|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
10952788|NCT00819286|EG000|Reported Event|Wire (Control)|patients will have their sternum closed using stainless steel wires.
10952789|NCT00819286|EG001|Reported Event|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
10952790|NCT00819390|BG000|Baseline|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952791|NCT00819390|BG001|Baseline|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952792|NCT00819390|BG002|Baseline|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952793|NCT00819390|BG003|Baseline|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952794|NCT00819390|BG004|Baseline|Total|Total of all reporting groups
10952795|NCT00819390|FG000|Participant Flow|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952796|NCT00819390|FG001|Participant Flow|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952797|NCT00819390|FG002|Participant Flow|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952798|NCT00819390|FG003|Participant Flow|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952799|NCT00819390|OG000|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
11178469|NCT02047344|BG001|Baseline|K- Ras Mutant|Fresh or archival biopsy tissue to determine KRAS is mutant. Patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression.
11178470|NCT02047344|BG002|Baseline|Total|Total of all reporting groups
11178471|NCT02047344|FG000|Participant Flow|K-Ras Negative|Fresh or archival biopsy tissue to determine KRAS is not mutant.
11178472|NCT02047344|FG001|Participant Flow|K- Ras Mutant|Fresh or archival biopsy tissue to determine KRAS is mutant.
11178473|NCT02047344|OG000|Outcome|Progression-free Survival Rate/KRAS Negative Group|200mg TID for treating KRAS negative patients 12 weeks
10952800|NCT00819390|OG001|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952801|NCT00819390|OG002|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
11178474|NCT02047344|OG001|Outcome|Progression-free Survival Rate/KRAS Mutant Group|200mg TID for treating KRAS negative patients 12 weeks
11178475|NCT02047344|OG000|Outcome|Antroquinonol (Hocena)|patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
11178476|NCT02047344|OG001|Outcome|Antroquinonol Day 28|continue use Antroquinonol for 28 Days
11178477|NCT02047344|OG000|Outcome|Non- Prior Chemotherapies|Patient without any chemotherapy before join Study
11178478|NCT02047344|OG001|Outcome|One Line Failed Prior Chemotherapies|Patient join with One line failed prior chemotherapies
11178479|NCT02047344|OG002|Outcome|Two Lines Failed Prior Chemotherapies|Patients join with two lines failed prior chemotherapies
11178480|NCT02047344|OG003|Outcome|More Than Two Lines Failed Prior Chemotherapies|patient failed more than two line chemotherapies before join.
11178481|NCT02047344|OG000|Outcome|Antroquinonol (Hocena)|"patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.~Antroquinonol: patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first."
11178482|NCT02047344|EG000|Reported Event|Antroquinonol (Hocena)|patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
11178483|NCT02047500|BG000|Baseline|TH-302 Plus Nab-paclitaxel Plus Gemcitabine|"TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11178484|NCT02047500|FG000|Participant Flow|TH-302 Plus Nab-paclitaxel Plus Gemcitabine|"TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11234338|NCT02433834|EG005|Reported Event|Placebo MDI|Placebo MDI.
11234339|NCT02433834|EG006|Reported Event|SAL 50 µg|salmeterol 50 µg
10952802|NCT00819390|OG003|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952803|NCT00819390|OG001|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952804|NCT00819390|OG000|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952805|NCT00819390|OG001|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952806|NCT00819390|EG000|Reported Event|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952807|NCT00819390|EG001|Reported Event|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952808|NCT00819390|EG002|Reported Event|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952809|NCT00819390|EG003|Reported Event|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
10952810|NCT00819403|BG000|Baseline|Simvastatin|"Simvastatin 40 mg daily~simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
10952811|NCT00819403|BG001|Baseline|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.~ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
10952812|NCT00819403|BG002|Baseline|Total|Total of all reporting groups
10952813|NCT00819403|FG000|Participant Flow|Simvastatin Then Simvastatin/Ezetimibe|"Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily~Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied."
10952814|NCT00819403|FG001|Participant Flow|Simvastatin/Ezetimibe Then Simvastatin|Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
10952815|NCT00819403|OG000|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
10952816|NCT00819403|OG001|Outcome|Simvastatin/Ezetimibe|Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
10952817|NCT00819403|OG001|Outcome|Simvastatin/Ezetimibe|Ezetimibe/simvastatin 10/40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
10952818|NCT00819403|EG000|Reported Event|Simvastatin|"Simvastatin 40 mg daily~simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
11192307|NCT02138227|FG000|Participant Flow|Assisted CEaD Condition|"In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.~Assisted CEaD Condition: In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills. OPO requesters will be assisted by having the CEaD DVD supplemented through working the scenarios with live simulated patients who will be trained to act out the scenarios with the OPO requesters and provide feedback."
10952819|NCT00819403|EG001|Reported Event|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.~ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
10952820|NCT00819507|BG000|Baseline|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
10952821|NCT00819507|FG000|Participant Flow|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
10952822|NCT00819507|OG000|Outcome|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
10952823|NCT00819507|EG000|Reported Event|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
10952824|NCT00819585|BG000|Baseline|Core Study: Canakinumab 25 mg|Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952825|NCT00819585|BG001|Baseline|Core Study: Canakinumab 50 mg|Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952826|NCT00819585|BG002|Baseline|Core Study: Canakinumab 100 mg|Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952827|NCT00819585|BG003|Baseline|Core Study: Canakinumab 200 mg|Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952828|NCT00819585|BG004|Baseline|Core Study: Canakinumab 300 mg|Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952829|NCT00819585|BG005|Baseline|Core Study: Canakinumab q4wk|Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
10952830|NCT00819585|BG006|Baseline|Core Study: Colchicine 0.5 mg|Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
10952831|NCT00819585|BG007|Baseline|Total|Total of all reporting groups
10952832|NCT00819585|FG000|Participant Flow|Core Study: Canakinumab 25 mg|Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952833|NCT00819585|FG001|Participant Flow|Core Study: Canakinumab 50 mg|Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952834|NCT00819585|FG002|Participant Flow|Core Study: Canakinumab 100 mg|Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
11178485|NCT02047500|OG000|Outcome|TH-302 Plus Nab-paclitaxel Plus Gemcitabine|"TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal."
11192308|NCT02138227|FG001|Participant Flow|Autonomous CEaD Condition|"In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.~Autonomous CEaD Condition: In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide."
10952835|NCT00819585|FG003|Participant Flow|Core Study: Canakinumab 200 mg|Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952836|NCT00819585|FG004|Participant Flow|Core Study: Canakinumab 300 mg|Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952837|NCT00819585|FG005|Participant Flow|Core Study: Canakinumab q4wk|Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
10952838|NCT00819585|FG006|Participant Flow|Core Study: Colchicine 0.5 mg|Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
10952839|NCT00819585|FG007|Participant Flow|Extension Study: Group A|Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
10952840|NCT00819585|FG008|Participant Flow|Extension Study: Group B|Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study.
10952841|NCT00819585|FG009|Participant Flow|Extension Study: Group C|Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
10952842|NCT00819585|FG010|Participant Flow|Extension Study: Group D|Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.
10952843|NCT00819585|OG000|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
10952844|NCT00819585|OG001|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
10952845|NCT00819585|OG002|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
10952846|NCT00819585|OG003|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
10952847|NCT00819585|OG004|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
10952848|NCT00819585|OG005|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
10952849|NCT00819585|OG000|Outcome|Core Study: Canakinumab 25 mg|Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952850|NCT00819585|OG001|Outcome|Core Study: Canakinumab 50 mg|Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952851|NCT00819585|OG002|Outcome|Core Study: Canakinumab 100 mg|Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952852|NCT00819585|OG003|Outcome|Core Study: Canakinumab 200 mg|Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952853|NCT00819585|OG004|Outcome|Core Study: Canakinumab 300 mg|Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10952854|NCT00819585|OG005|Outcome|Core Study: Canakinumab q4wk|Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
11178486|NCT02047500|EG000|Reported Event|TH-302 Plus Nab-paclitaxel Plus Gemcitabine|"TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal."
10952855|NCT00819585|OG006|Outcome|Core Study: Colchicine 0.5 mg|Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
10952856|NCT00819585|OG000|Outcome|Extension Study: Group A|Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
10952857|NCT00819585|OG001|Outcome|Extension Study: Group C|Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
10952858|NCT00819585|EG000|Reported Event|Core Study: ACZ 25 mg|Core study: ACZ 25 mg
10952859|NCT00819585|EG001|Reported Event|Core Study: ACZ 50 mg|Core study: ACZ 50 mg
10952860|NCT00819585|EG002|Reported Event|Core Study: ACZ 100 mg|Core study: ACZ 100 mg
10952861|NCT00819585|EG003|Reported Event|Core Study: ACZ 200 mg|Core study: ACZ 200 mg
10952862|NCT00819585|EG004|Reported Event|Core Study: ACZ 300 mg|Core study: ACZ 300 mg
10952863|NCT00819585|EG005|Reported Event|Core Study: ACZ Q4wk mg|Core study: ACZ Q4wk mg
10952864|NCT00819585|EG006|Reported Event|Core Study: Colch 0.5 mg|Core study: Colch 0.5 mg
10952865|NCT00819585|EG007|Reported Event|Extension Study: Group A|Extension study: Group A
10952866|NCT00819585|EG008|Reported Event|Extension Study: Group B|Extension study: Group B
10952867|NCT00819585|EG009|Reported Event|Extension Study: Group C|Extension study: Group C
10952868|NCT00819585|EG010|Reported Event|Extension Study: Group D|Extension study: Group D
10952869|NCT00819637|BG000|Baseline|Arformoterol 1 Dose, Placebo 2 Doses|
10952870|NCT00819637|BG001|Baseline|Arformoterol 3 Doses|
10952871|NCT00819637|BG002|Baseline|Levalbuterol 3 Doses|
10952872|NCT00819637|BG003|Baseline|Total|Total of all reporting groups
10952873|NCT00819637|FG000|Participant Flow|Arformoterol 1 Dose, Placebo 2 Doses|
10952874|NCT00819637|FG001|Participant Flow|Arformoterol 3 Doses|
10952875|NCT00819637|FG002|Participant Flow|Levalbuterol 3 Doses|
10952876|NCT00819637|OG000|Outcome|Arformoterol 1 Dose, Placebo 2 Doses|
10952877|NCT00819637|OG001|Outcome|Arformoterol 3 Doses|
10952878|NCT00819637|OG002|Outcome|Levalbuterol 3 Doses|
10952879|NCT00819637|EG000|Reported Event|Arformoterol 1 Dose, Placebo 2 Doses|
10952880|NCT00819637|EG001|Reported Event|Arformoterol 3 Doses|
10952881|NCT00819637|EG002|Reported Event|Levalbuterol 3 Doses|
10952882|NCT00819741|BG000|Baseline|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
10952883|NCT00819741|BG001|Baseline|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
10952884|NCT00819741|BG002|Baseline|Total|Total of all reporting groups
10952885|NCT00819741|FG000|Participant Flow|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
10952886|NCT00819741|FG001|Participant Flow|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
10952887|NCT00819741|OG000|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
10952888|NCT00819741|OG001|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
10952889|NCT00819741|EG000|Reported Event|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
10952890|NCT00819741|EG001|Reported Event|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
10952891|NCT00819767|BG000|Baseline|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
10952892|NCT00819767|BG001|Baseline|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
10952893|NCT00819767|BG002|Baseline|Total|Total of all reporting groups
10952894|NCT00819767|FG000|Participant Flow|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
10952895|NCT00819767|FG001|Participant Flow|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
10952896|NCT00819767|OG000|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
10952897|NCT00819767|OG001|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
10952898|NCT00819767|EG000|Reported Event|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
10952899|NCT00819767|EG001|Reported Event|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
10952900|NCT00819780|BG000|Baseline|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
10952901|NCT00819780|BG001|Baseline|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
10952902|NCT00819780|BG002|Baseline|Total|Total of all reporting groups
10952903|NCT00819780|FG000|Participant Flow|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU; 2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
11178487|NCT02047604|BG000|Baseline|Cohort A - SAN-300 0.5 mg/kg QW|SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
11178488|NCT02047604|BG001|Baseline|Cohort B - SAN-300 1.0 mg/kg QW|SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
11178489|NCT02047604|BG002|Baseline|Cohort C - SAN-300 2.0 mg/kg QOW|SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
11178490|NCT02047604|BG003|Baseline|Cohort D - SAN-300 4.0 mg/kg QOW|SAN-300 4.0 mg/kg subcutaneous every other week for six weeks
11178491|NCT02047604|BG004|Baseline|Cohort E - SAN-300 4.0 mg/kg QW|SAN-300 4.0 mg/kg subcutaneous once weekly for six weeks
10952904|NCT00819780|FG001|Participant Flow|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
10952905|NCT00819780|OG000|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
10952906|NCT00819780|OG001|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
10952907|NCT00819780|EG000|Reported Event|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
10952908|NCT00819780|EG001|Reported Event|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
10952914|NCT00819910|BG000|Baseline|Rosiglitazone/Fenofibrate Therapy Daily|Rosiglitazone 8mg once daily and Fenofibrate 145mg once daily for 12 weeks
10952915|NCT00819910|BG001|Baseline|Fenofibrate + Placebo|Fenofibrate 145mg once daily for 12 weeks and Placebo (Rosiglitazone 8mg once daily)
10952916|NCT00819910|BG002|Baseline|Rosiglitazone + Placebo|Rosiglitazone 8mg once daily and Placebo ( Fenofibrate 145mg once daily)
10952917|NCT00819910|BG003|Baseline|Placebo Therapy Daily|Placebo (Rosiglitazone 8mg once daily) and placebo (Fenofibrate 145 mg once daily) for 12 weeks
10952918|NCT00819910|BG004|Baseline|Total|Total of all reporting groups
10952919|NCT00819910|FG000|Participant Flow|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
10952920|NCT00819910|FG001|Participant Flow|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
10952921|NCT00819910|FG002|Participant Flow|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
10952922|NCT00819910|FG003|Participant Flow|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
10952923|NCT00819910|OG000|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
10952924|NCT00819910|OG001|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
10952925|NCT00819910|OG002|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
10952926|NCT00819910|OG003|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
10952927|NCT00819910|OG000|Outcome|Rosiglitazone and Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
10952928|NCT00819910|OG002|Outcome|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
10952929|NCT00819910|EG000|Reported Event|Rosiglitazone/Fenofibrate Therapy Daily|"Rosiglitazone 8mg po daily + Fenofibrate 145 mg po daily for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
10952930|NCT00819910|EG001|Reported Event|Rosiglitazone + Placebo|"Rosiglitazone 8mg po daily + Placebo (Fenofibrate 145 mg po daily) for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
10952931|NCT00819910|EG002|Reported Event|Fenofibrate + Placebo|"Fenofibrate 145 mg po daily for 12 weeks= Placebo (Rosiglitazone 8mg po daily)~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
10952932|NCT00819910|EG003|Reported Event|Placebo Therapy Daily|"Rosiglitazone (placebo) once daily and Fenofibrate (placebo)once daily for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
10952933|NCT00820040|BG000|Baseline|Permacol|acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
11178492|NCT02047604|BG005|Baseline|Placebo|Placebo dosing
11178493|NCT02047604|BG006|Baseline|Total|Total of all reporting groups
10952934|NCT00820040|FG000|Participant Flow|Permacol|acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
10952935|NCT00820040|OG000|Outcome|Permacol|acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
10952936|NCT00820040|EG000|Reported Event|Permacol|acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
10952937|NCT00820170|BG000|Baseline|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
10952938|NCT00820170|BG001|Baseline|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
10952939|NCT00820170|BG002|Baseline|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
10952940|NCT00820170|BG003|Baseline|Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
10952941|NCT00820170|BG004|Baseline|No Arm Selected|No Treatment Arm Selected
10952942|NCT00820170|BG005|Baseline|Total|Total of all reporting groups
11178494|NCT02047604|FG000|Participant Flow|Cohort A - SAN-300 0.5 mg/kg QW|SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
10952943|NCT00820170|FG000|Participant Flow|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
10952944|NCT00820170|FG001|Participant Flow|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
10952945|NCT00820170|FG002|Participant Flow|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
10952946|NCT00820170|FG003|Participant Flow|Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
10952947|NCT00820170|FG004|Participant Flow|Participants Who Did Not Receive Treatment|Participants did not receive treatment
10952948|NCT00820170|OG000|Outcome|Dasatinib and Paclitaxel|"The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.~The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.~Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:~Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.~The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel."
11178495|NCT02047604|FG001|Participant Flow|Cohort B - SAN-300 1.0 mg/kg QW|SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
11178496|NCT02047604|FG002|Participant Flow|Cohort C - SAN-300 2.0 mg/kg QOW|SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
11178497|NCT02047604|FG003|Participant Flow|Cohort D - SAN-300 4.0 mg/kg QOW|SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
11178498|NCT02047604|FG004|Participant Flow|Cohort E - SAN-300 4.0 mg/kg QW|SAN-300 4.0 mg/kg subcutaneous every week for six weeks
11178499|NCT02047604|FG005|Participant Flow|Placebo|Placebo dosing
11178500|NCT02047604|OG000|Outcome|Cohort A - SAN-300 0.5 mg/kg QW|SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
10952949|NCT00820170|OG000|Outcome|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
10952950|NCT00820170|OG001|Outcome|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
10952951|NCT00820170|OG002|Outcome|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
10952952|NCT00820170|OG003|Outcome|Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
10952953|NCT00820170|OG004|Outcome|No Arm Selected|No Treatment Arm Selected
10952954|NCT00820170|OG000|Outcome|Arm 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
10952955|NCT00820170|OG001|Outcome|Arm 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
10952956|NCT00820170|OG002|Outcome|Arm 3: Paclitaxel 80 mg/m2 + Dasatinib 150 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
10952957|NCT00820170|OG003|Outcome|Paclitaxel 80 mg/m2 + Dasatinib 70 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
10952958|NCT00820170|EG000|Reported Event|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
10952959|NCT00820170|EG001|Reported Event|Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
10952960|NCT00820170|EG002|Reported Event|Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
11178501|NCT02047604|OG001|Outcome|Cohort B - SAN-300 1.0 mg/kg QW|SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
11178502|NCT02047604|OG002|Outcome|Cohort C - SAN-300 2.0 mg/kg QOW|SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
11178503|NCT02047604|OG003|Outcome|Cohort D - SAN-300 4.0 mg/kg QOW|SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
11178504|NCT02047604|OG004|Outcome|Cohort E - SAN-300 4.0 mg/kg QW|SAN-300 4.0 mg/kg subcutaneous every week for six weeks
11178505|NCT02047604|OG005|Outcome|Placebo|Placebo dosing
11178506|NCT02047604|EG000|Reported Event|Cohort A - SAN-300 0.5 mg/kg QW|SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
11178507|NCT02047604|EG001|Reported Event|Cohort B - SAN-300 1.0 mg/kg QW|SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
11178508|NCT02047604|EG002|Reported Event|Cohort C - SAN-300 2.0 mg/kg QOW|SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
10952961|NCT00820170|EG003|Reported Event|Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg|Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
10952962|NCT00820170|EG004|Reported Event|No Arm Selected|No Treatment Arm Selected
10952963|NCT00820222|BG000|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
10952964|NCT00820222|BG001|Baseline|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
10952965|NCT00820222|BG002|Baseline|Total|Total of all reporting groups
10952966|NCT00820222|FG000|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
10952967|NCT00820222|FG001|Participant Flow|Trastuzumab Plus Capecitabine|Participants received an intravenous (IV) infusion of trastuzumab 8 mg/kilogram (kg) on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
10952968|NCT00820222|OG000|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
10952969|NCT00820222|OG001|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
10952970|NCT00820222|EG000|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
10952971|NCT00820222|EG001|Reported Event|Trastuzumab Plus Capecitabine|Participants received an intravenous (IV) infusion of trastuzumab 8 mg/kilogram (kg) on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
10952972|NCT00820235|BG000|Baseline|Group-A. OsseoSpeed™ Implant|Subjects that had OsseoSpeed™ implants installed.
10952973|NCT00820235|BG001|Baseline|Group-B. NobelSpeedy™ Replace® Implant|Subjects that had NobelSpeedy™ Replace® implants installed
10952974|NCT00820235|BG002|Baseline|Group-C. NanoTite™ Certain® PREVAIL® Implant|Subjects that had NanoTite™ Certain® PREVAIL® implants installed
10952975|NCT00820235|BG003|Baseline|Total|Total of all reporting groups
10952976|NCT00820235|FG000|Participant Flow|Group-A. OsseoSpeed™ Implant|Subjects that had OsseoSpeed™ implants installed.
10952977|NCT00820235|FG001|Participant Flow|Group-B. NobelSpeedy™ Replace® Implant|Subjects that had NobelSpeedy™ Replace® implants installed
10952978|NCT00820235|FG002|Participant Flow|Group-C. NanoTite™ Certain® PREVAIL® Implant|Subjects that had NanoTite™ Certain® PREVAIL® implants installed
10952979|NCT00820235|OG000|Outcome|Group-A. OsseoSpeed™ Implant|Subjects that had OsseoSpeed™ implants installed.
10952980|NCT00820235|OG001|Outcome|Group-B. NobelSpeedy™ Replace® Implant|Subjects that had NobelSpeedy™ Replace® implants installed
10952981|NCT00820235|OG002|Outcome|Group-C. NanoTite™ Certain® PREVAIL® Implant|Subjects that had NanoTite™ Certain® PREVAIL® implants installed
10952982|NCT00820235|EG000|Reported Event|Group-A. OsseoSpeed™ Implant|Subjects that had OsseoSpeed™ implants installed.
10952983|NCT00820235|EG001|Reported Event|Group-B. NobelSpeedy™ Replace® Implant|Subjects that had NobelSpeedy™ Replace® implants installed
10952984|NCT00820235|EG002|Reported Event|Group-C. NanoTite™ Certain® PREVAIL® Implant|Subjects that had NanoTite™ Certain® PREVAIL® implants installed
11178509|NCT02047604|EG003|Reported Event|Cohort D - SAN-300 4.0 mg/kg QOW|SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
11178510|NCT02047604|EG004|Reported Event|Cohort E - SAN-300 4.0 mg/kg QW|SAN-300 4.0 mg/kg subcutaneous every week for six weeks
11178511|NCT02047604|EG005|Reported Event|Placebo|Placebo dosing
10952985|NCT00820248|BG000|Baseline|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
10952986|NCT00820248|BG001|Baseline|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
10952987|NCT00820248|BG002|Baseline|Total|Total of all reporting groups
10952988|NCT00820248|FG000|Participant Flow|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
10952989|NCT00820248|FG001|Participant Flow|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
10952990|NCT00820248|OG000|Outcome|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
10952991|NCT00820248|OG001|Outcome|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
10952992|NCT00820248|EG000|Reported Event|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
10952993|NCT00820248|EG001|Reported Event|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
10952994|NCT00820443|BG000|Baseline|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
10952995|NCT00820443|FG000|Participant Flow|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
10952996|NCT00820443|OG000|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
11178512|NCT02047643|BG000|Baseline|All Participants|Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
10952997|NCT00820443|OG000|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component"
10952998|NCT00820443|EG000|Reported Event|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
10952999|NCT00820534|BG000|Baseline|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
10953000|NCT00820534|BG001|Baseline|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
10953001|NCT00820534|BG002|Baseline|Total|Total of all reporting groups
10953002|NCT00820534|FG000|Participant Flow|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
10953003|NCT00820534|FG001|Participant Flow|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
10953004|NCT00820534|OG000|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
10953005|NCT00820534|OG001|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
10953006|NCT00820534|EG000|Reported Event|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
10953007|NCT00820534|EG001|Reported Event|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
10953008|NCT00820573|BG000|Baseline|Placebo|all subjects after 6 weeks of placebo therapy
10953009|NCT00820573|BG001|Baseline|Metformin|all subjects after receiving 6 weeks of metformin therapy
10953010|NCT00820573|BG002|Baseline|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
10953011|NCT00820573|BG003|Baseline|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
10953012|NCT00820573|BG004|Baseline|Total|Total of all reporting groups
10953013|NCT00820573|FG000|Participant Flow|Placebo,Sitagliptin,Metformin and Sitagliptin Plus Metformin|Sequence as described, starting placebo therapy for 6 weeks,followed by sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks and the combination sitagliptn plus metformin for the final 6 weeks
10953014|NCT00820573|FG001|Participant Flow|Sitagliptin, Metformin, Sitagliptin Plus Metformin, Placebo|Sequence as described, starting with sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks and then placebo therapy for the final 6 weeks
10953015|NCT00820573|FG002|Participant Flow|Metformin, Sitagliptin Plus Metformin, Sitagliptin,Placebo|Sequence as described, starting with metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily followed by placebo therapy for the final 6 weeks
10953016|NCT00820573|FG003|Participant Flow|Sitagliptin Plus Metformin, Sitagliptin, Placebo,Metformin|Sequence as described, starting with combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily placebo therapy for 6 weeks and finally metforminfor 6 weeks.
10953017|NCT00820573|OG000|Outcome|Placebo|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
10953018|NCT00820573|OG001|Outcome|Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
10953019|NCT00820573|OG002|Outcome|Sitagliptin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
10953020|NCT00820573|OG003|Outcome|Sitagliptin Plus Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
10953021|NCT00820573|OG000|Outcome|Placebo|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin.
10953022|NCT00820573|OG001|Outcome|Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
10953023|NCT00820573|OG002|Outcome|Sitagliptin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
10953024|NCT00820573|OG003|Outcome|Sitagliptin Plus Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
10953025|NCT00820573|OG000|Outcome|Placebo|"Sitagliptin~Sitagliptin : tablet, 100 mg/day, 6 weeks"
10953026|NCT00820573|OG001|Outcome|Metformin|"Metformin~Metformin : tablet, 1000 mg/ bid, 6 weeks"
11192309|NCT02138227|OG000|Outcome|Pre-Intervention Authorization Rate (All Novice)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Novice participants are defined has having less than 12 months of experience.
10953027|NCT00820573|OG002|Outcome|Sitagliptin|"Sitagliptin + Metformin~Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
10953028|NCT00820573|OG003|Outcome|Sitagliptin + Metformin|placebo for 6 weeks
10953029|NCT00820573|OG003|Outcome|Sitagliptin+Metformin|placebo for 6 weeks
10953030|NCT00820573|EG000|Reported Event|Placebo|all subjects after 6 weeks of placebo therapy
10953031|NCT00820573|EG001|Reported Event|Metformin|all subjects after receiving 6 weeks of metformin therapy
10953032|NCT00820573|EG002|Reported Event|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
10953033|NCT00820573|EG003|Reported Event|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
10953034|NCT00820599|BG000|Baseline|TAVR|"Transaortic Valve Replacement~Sapien XT™ transcatheter heart valve and delivery system"
10953035|NCT00820599|FG000|Participant Flow|TAVR|"Transaortic Valve Replacement~Sapien XT™ transcatheter heart valve and delivery system"
10953036|NCT00820599|OG000|Outcome|TAVR|"Transaortic Valve Replacement~Sapien XT™ transcatheter heart valve and delivery system"
10953037|NCT00820599|EG000|Reported Event|TAVR|"Transaortic Valve Replacement~Sapien XT™ transcatheter heart valve and delivery system"
10953038|NCT00820612|BG000|Baseline|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
10953039|NCT00820612|BG001|Baseline|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
10953040|NCT00820612|BG002|Baseline|Total|Total of all reporting groups
10953041|NCT00820612|FG000|Participant Flow|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
10953042|NCT00820612|FG001|Participant Flow|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
10953043|NCT00820612|OG000|Outcome|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
10953044|NCT00820612|OG001|Outcome|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
10953045|NCT00820612|EG000|Reported Event|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
10953046|NCT00820612|EG001|Reported Event|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
10953047|NCT00820664|BG000|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
10953048|NCT00820664|BG001|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
10953049|NCT00820664|BG002|Baseline|Placebo|
10953050|NCT00820664|BG003|Baseline|Total|Total of all reporting groups
10953051|NCT00820664|FG000|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
10953052|NCT00820664|FG001|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
10953053|NCT00820664|FG002|Participant Flow|Placebo|
10953054|NCT00820664|OG000|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
10953055|NCT00820664|OG001|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
10953056|NCT00820664|OG002|Outcome|Placebo|
10953057|NCT00820664|EG000|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
10953058|NCT00820664|EG001|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
10953059|NCT00820664|EG002|Reported Event|Placebo|
10953060|NCT00820755|BG000|Baseline|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
10953061|NCT00820755|FG000|Participant Flow|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
10953062|NCT00820755|FG001|Participant Flow|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
10953063|NCT00820755|FG002|Participant Flow|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
10953064|NCT00820755|OG000|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
10953065|NCT00820755|OG001|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
10953066|NCT00820755|OG000|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
10953067|NCT00820755|EG000|Reported Event|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
10953068|NCT00820755|EG001|Reported Event|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression after combination therapy, they administered with cetuximab 500 mg/m^2 intravenously for 2 weeks, for up to PD, development of unacceptable toxicities, or withdrawal of consent after the end of combination therapy.
10953069|NCT00820755|EG002|Reported Event|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
11192310|NCT02138227|OG001|Outcome|Post-Intervention Authorization Rate (Novice Autonomous Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Novice participants are defined has having less than 12 months of experience.
10953070|NCT00820872|BG000|Baseline|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
10953071|NCT00820872|FG000|Participant Flow|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
10953072|NCT00820872|OG000|Outcome|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
10953073|NCT00820872|EG000|Reported Event|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
10953074|NCT00820898|BG000|Baseline|Gemcitabine|Gemcitabine 800mg/m2 I.V. Days 1 and 8 every 21 days (one cycle)
10953075|NCT00820898|FG000|Participant Flow|Gemcitabine|Gemcitabine 800mg/m2 I.V. Days 1 and 8 every 21 days (one cycle)
10953076|NCT00820898|OG000|Outcome|Gemcitabine|Gemcitabine 800mg/m2 I.V. Days 1 and 8 every 21 days (one cycle)
10953077|NCT00820898|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10953078|NCT00820898|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10953079|NCT00820898|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10953080|NCT00820898|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10953081|NCT00820898|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10953082|NCT00820898|OG005|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10953083|NCT00820898|EG000|Reported Event|Gemcitabine|Gemcitabine 800mg/m2 I.V. Days 1 and 8 every 21 days (one cycle)
11178513|NCT02047643|FG000|Participant Flow|On-algorithm First, Then Off-algorithm|Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
11192311|NCT02138227|OG002|Outcome|Post-Authorization Rate (Novice Assisted Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Novice participants are defined has having less than 12 months of experience.
10953084|NCT00821015|BG000|Baseline|Cryoballoon Catheter|"All study subjects will undergo cryoablation. This is a non-randomized trial.~Pulmonary vein isolation with cryoballoon catheter: For each patient, the balloon catheter will be advanced to the ostium of each pulmonary vein. Once location has been optimized, the balloon will be inflated, and cryoenergy delivery will be initiated. Because the entire surface of the balloon acts as an ablative surface, circumferential ablation of each pulmonary vein will be achieved concurrently. This will be completed for each pulmonary vein for each patient."
10953085|NCT00821015|FG000|Participant Flow|Cryoballoon Catheter|"All study subjects will undergo cryoablation. This is a non-randomized trial.~Pulmonary vein isolation with cryoballoon catheter: For each patient, the balloon catheter will be advanced to the ostium of each pulmonary vein. Once location has been optimized, the balloon will be inflated, and cryoenergy delivery will be initiated. Because the entire surface of the balloon acts as an ablative surface, circumferential ablation of each pulmonary vein will be achieved concurrently. This will be completed for each pulmonary vein for each patient."
10953086|NCT00821015|OG000|Outcome|Cryoballoon Catheter|"All study subjects will undergo cryoablation. This is a non-randomized trial.~Pulmonary vein isolation with cryoballoon catheter: For each patient, the balloon catheter will be advanced to the ostium of each pulmonary vein. Once location has been optimized, the balloon will be inflated, and cryoenergy delivery will be initiated. Because the entire surface of the balloon acts as an ablative surface, circumferential ablation of each pulmonary vein will be achieved concurrently. This will be completed for each pulmonary vein for each patient."
10953087|NCT00821015|EG000|Reported Event|Cryoballoon Catheter|"All study subjects will undergo cryoablation. This is a non-randomized trial.~Pulmonary vein isolation with cryoballoon catheter: For each patient, the balloon catheter will be advanced to the ostium of each pulmonary vein. Once location has been optimized, the balloon will be inflated, and cryoenergy delivery will be initiated. Because the entire surface of the balloon acts as an ablative surface, circumferential ablation of each pulmonary vein will be achieved concurrently. This will be completed for each pulmonary vein for each patient."
10953088|NCT00821041|BG000|Baseline|Waiting List Control|
10953089|NCT00821041|BG001|Baseline|Cognitive Behavioral Therapy|
10953090|NCT00821041|BG002|Baseline|Total|Total of all reporting groups
10953091|NCT00821041|FG000|Participant Flow|Waiting List Control|
10953092|NCT00821041|FG001|Participant Flow|Cognitive Behavioral Therapy|
10953093|NCT00821041|OG000|Outcome|Waiting List Control|
10953094|NCT00821041|OG001|Outcome|Cognitive Behavioral Therapy|
10953095|NCT00821041|EG000|Reported Event|Waiting List Control|
10953096|NCT00821041|EG001|Reported Event|Cognitive Behavioral Therapy|
10953097|NCT00821093|BG000|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10953098|NCT00821093|BG001|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10953099|NCT00821093|BG002|Baseline|Total|Total of all reporting groups
10953100|NCT00821093|FG000|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10953101|NCT00821093|FG001|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10953102|NCT00821093|OG000|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11341762|NCT03687827|FG000|Participant Flow|Sequence A: Insulin Degludec 100U/mL Then Insulin Glargine 100U/mL|Participants were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL (Units per milliliter) once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
10953103|NCT00821093|OG001|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10953104|NCT00821093|EG000|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10953105|NCT00821093|EG001|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10953106|NCT00821119|BG000|Baseline|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
10953107|NCT00821119|BG001|Baseline|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
10953108|NCT00821119|BG002|Baseline|Total|Total of all reporting groups
10953109|NCT00821119|FG000|Participant Flow|Nasal Continuous Positive Airway Pressure (NCPAP)|Continuous nasal positive airway pressure as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life. Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
10953110|NCT00821119|FG001|Participant Flow|Nasal Intermittent Positive Pressure Ventilation (NIPPV)|Nasal intermittent positive pressure ventilation as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life.We used a time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
10953111|NCT00821119|OG000|Outcome|NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
10953112|NCT00821119|OG001|Outcome|NIPPV|preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
10953113|NCT00821119|OG000|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
10953114|NCT00821119|OG001|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
10953115|NCT00821119|EG000|Reported Event|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
10953116|NCT00821119|EG001|Reported Event|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
10953117|NCT00821184|BG000|Baseline|Vesicare Alone|Vesicare alone in treatment of incontinence
10953118|NCT00821184|BG001|Baseline|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
10953119|NCT00821184|BG002|Baseline|Total|Total of all reporting groups
10953120|NCT00821184|FG000|Participant Flow|Vesicare Alone|Vesicare alone in treatment of incontinence
10953121|NCT00821184|FG001|Participant Flow|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
10953122|NCT00821184|OG000|Outcome|Vesicare Alone|Vesicare alone in treatment of incontinence
10953123|NCT00821184|OG001|Outcome|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
10953124|NCT00821184|OG000|Outcome|Vesicare|"Vesicare alone~Vesicare (solifenacin): 5mg po qd"
10953125|NCT00821184|OG001|Outcome|Vesicare/Behavioral Modification|"Vesicare plus behavioral modification~Vesicare (solifenacin) plus behavioral modification: 5 mg dose po once daily plus behavioral modification"
10953126|NCT00821184|EG000|Reported Event|Vesicare Alone|Vesicare alone in treatment of incontinence
10953127|NCT00821184|EG001|Reported Event|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
10963687|NCT00873782|FG000|Participant Flow|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
10963688|NCT00873782|OG000|Outcome|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
10963689|NCT00873782|EG000|Reported Event|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
10953128|NCT04187989|BG000|Baseline|Social Media Intervention|"Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors.~Social Media Intervention: Information will be posted by e-coaches. You can interact with the e-coaches as well as other study members in your group."
10953129|NCT04187989|BG001|Baseline|Control|An Attention-Control E-News (control) condition
10953130|NCT04187989|BG002|Baseline|Total|Total of all reporting groups
10953131|NCT04187989|FG000|Participant Flow|Social Media Intervention|"Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors.~Social Media Intervention: Information will be posted by e-coaches. You can interact with the e-coaches as well as other study members in your group."
10953132|NCT04187989|FG001|Participant Flow|Control|An Attention-Control E-News (control) condition
10953133|NCT04187989|OG000|Outcome|Social Media Intervention|"Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors.~Social Media Intervention: Information will be posted by e-coaches. You can interact with the e-coaches as well as other study members in your group."
10953134|NCT04187989|OG001|Outcome|Control|An Attention-Control E-News (control) condition
10953135|NCT04187989|EG000|Reported Event|Social Media Intervention|"Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors.~Social Media Intervention: Information will be posted by e-coaches. You can interact with the e-coaches as well as other study members in your group."
10953136|NCT04187989|EG001|Reported Event|Control|An Attention-Control E-News (control) condition
10953137|NCT04109118|BG000|Baseline|Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)|"This is a pilot clinical trial of the DT-BD intervention. The study population will consist of outpatients receiving OAT for opioid use disorder who are also using BZDs regularly. All participants will receive the same BZD discontinuation protocol.~DT-BD is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist BZD discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the BZD taper. The taper occurs over 9 weeks and involves weekly meetings with a BZD prescriber during which a gradual BZD dose reduction will take place.~Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper."
10953138|NCT04109118|FG000|Participant Flow|Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)|"This is a pilot clinical trial of the DT-BD intervention. The study population will consist of outpatients receiving OAT for opioid use disorder who are also using BZDs regularly. All participants will receive the same BZD discontinuation protocol.~DT-BD is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist BZD discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the BZD taper. The taper occurs over 9 weeks and involves weekly meetings with a BZD prescriber during which a gradual BZD dose reduction will take place.~Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper."
10953139|NCT04109118|OG000|Outcome|Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)|"This is a pilot clinical trial of the DT-BD intervention. The study population will consist of outpatients receiving OAT for opioid use disorder who are also using BZDs regularly. All participants will receive the same BZD discontinuation protocol.~DT-BD is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist BZD discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the BZD taper. The taper occurs over 9 weeks and involves weekly meetings with a BZD prescriber during which a gradual BZD dose reduction will take place.~Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper."
10963690|NCT00873821|BG000|Baseline|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
11178514|NCT02047643|FG001|Participant Flow|Off-algorithm First, Then On-algorithm|Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
10953140|NCT04109118|OG000|Outcome|Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)|Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) is a psychosocial intervention. It is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist benzodiazepine discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the benzodiazepine taper. The taper for both the intervention and control conditions occurs over 9 weeks and involves weekly meetings with a benzodiazepine prescriber during which a gradual benzodiazepine dose reduction will take place. The DT-BD intervention combines elements of existing psychosocial interventions. Specifically, interoceptive exposure techniques will be paired with elements of acceptance and commitment therapy (ACT) and relapse prevention (RP).
10953141|NCT04109118|EG000|Reported Event|Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)|The study population will consist of outpatients receiving OAT for opioid use disorder who are also using BZDs regularly. All participants will receive the same BZD discontinuation protocol.
10953142|NCT04045132|BG000|Baseline|MoodGym Alone (Control)|"The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.~MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage)."
10953143|NCT04045132|BG001|Baseline|Parenting Program + MoodGym (Intervention)|"The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.~Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).~MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention."
10953144|NCT04045132|BG002|Baseline|Total|Total of all reporting groups
10953145|NCT04045132|FG000|Participant Flow|MoodGym Alone (Control)|"The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.~MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage)."
10953146|NCT04045132|FG001|Participant Flow|Parenting Program + MoodGym (Intervention)|"The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.~Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).~MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention."
11178515|NCT02047643|OG000|Outcome|On-algorithm|Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
11178516|NCT02047643|OG001|Outcome|Off-algorithm|Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
11178517|NCT02047643|EG000|Reported Event|On-algorithm|Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
10953147|NCT04045132|OG000|Outcome|MoodGym Alone (Control)|"The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.~MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage)."
10953148|NCT04045132|OG001|Outcome|Parenting Program + MoodGym (Intervention)|"The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.~Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).~MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention."
10953149|NCT04045132|OG000|Outcome|MoodGym Alone|"The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.~MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage)."
10953150|NCT04045132|OG001|Outcome|Parenting Program + MoodGym|"The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.~Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).~MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention."
10953151|NCT04045132|EG000|Reported Event|MoodGym Alone (Control)|"The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.~MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage)."
10963691|NCT00873821|BG001|Baseline|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
10963692|NCT00873821|BG002|Baseline|Total|Total of all reporting groups
10963693|NCT00873821|FG000|Participant Flow|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
11357659|NCT03751020|EG002|Reported Event|Self-Affirmation (SA)|"Self-Affirmation (SA) interventions prompt individuals to write advice to a (hypothetical) similarly stigmatized person regarding how best to cope with stigma-related stress. By affirming one's own stigmatized identity through the process of helping another similarly stigmatized person.~Self-Affirmation (SA) Intervention: The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences."
10953152|NCT04045132|EG001|Reported Event|Parenting Program + MoodGym (Intervention)|"The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.~Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).~MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention."
10953153|NCT03846219|BG000|Baseline|IMU-838 (30 mg/Day)|"During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]).~All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily)."
10953154|NCT03846219|BG001|Baseline|IMU-838 (45 mg/Day)|"During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]).~All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily)."
10953155|NCT03846219|BG002|Baseline|Placebo|"During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo.~All patients received 1 tablet per day during the first 7 days of the main treatment period and then started taking 2 tablets once daily from Day 7 onwards."
10953156|NCT03846219|BG003|Baseline|Total|Total of all reporting groups
11178518|NCT02047643|EG001|Reported Event|Off-algorithm|Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
11178519|NCT02047734|BG000|Baseline|Interferon Beta-1a (IFN β-1a)|Participants received IFN β-1a 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.
11178520|NCT02047734|BG001|Baseline|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.
11178521|NCT02047734|BG002|Baseline|Ozanimod 1 mg|Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.
10953157|NCT03846219|FG000|Participant Flow|IMU-838 (30 mg/Day)|During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953158|NCT03846219|FG001|Participant Flow|IMU-838 (45 mg/Day)|During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953159|NCT03846219|FG002|Participant Flow|Placebo|During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953160|NCT03846219|OG000|Outcome|IMU-838 (45 mg/Day)|During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
11178522|NCT02047734|BG003|Baseline|Total|Total of all reporting groups
11178523|NCT02047734|FG000|Participant Flow|Interferon Beta-1a (IFN β-1a)|Participants received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.
11178524|NCT02047734|FG001|Participant Flow|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.
11178525|NCT02047734|FG002|Participant Flow|Ozanimod 1 mg|Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.
11178526|NCT02047734|OG000|Outcome|Interferon Beta-1a|Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.
11178527|NCT02047734|OG001|Outcome|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.
10953161|NCT03846219|OG001|Outcome|Placebo|During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953162|NCT03846219|OG000|Outcome|IMU-838 (30 mg/Day)|During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953163|NCT03846219|OG001|Outcome|IMU-838 (45 mg/Day)|During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953164|NCT03846219|OG002|Outcome|Placebo|During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953165|NCT03846219|OG002|Outcome|Placebo (Compared With 30 and 45 mg IMU-838)|During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953166|NCT03846219|OG003|Outcome|IMU-838 Combined|Groups 30 mg IMU-838 and 45 mg IMU-838 combined
10953167|NCT03846219|OG004|Outcome|Placebo (Compared With IMU-838 Combined)|During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953168|NCT03846219|OG000|Outcome|IMU-838 (30 mg/Day)|"During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]).~All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily)."
10953169|NCT03846219|OG001|Outcome|IMU-838 (45 mg/Day)|"During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]).~All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily)."
11178528|NCT02047734|OG002|Outcome|Ozanimod 1 mg|Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.
11178529|NCT02047734|EG000|Reported Event|Interferon Beta-1a|Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.
10953170|NCT03846219|OG002|Outcome|Placebo|"During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo.~All patients received 1 tablet per day during the first 7 days of the main treatment period and then started taking 2 tablets once daily from Day 7 onwards."
10953171|NCT03846219|EG000|Reported Event|IMU-838 (30 mg/Day)|During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10953172|NCT03846219|EG001|Reported Event|IMU-838 (45 mg/Day)|During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
11178530|NCT02047734|EG001|Reported Event|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.
11178531|NCT02047734|EG002|Reported Event|Ozanimod 1 mg|Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.
10953173|NCT03846219|EG002|Reported Event|Placebo|During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days.
10963694|NCT00873821|FG001|Participant Flow|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
10963695|NCT00873821|OG000|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
10963696|NCT00873821|OG001|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
10963697|NCT00873821|EG000|Reported Event|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
11178532|NCT02047903|BG000|Baseline|Afatinib|Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
11192312|NCT02138227|OG003|Outcome|Pre-Intervention Authorization Rate (All Mid-Level)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
10953174|NCT03758404|BG000|Baseline|Low Dose AAV - CNGA3|"Subretinal administration of a single low dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953175|NCT03758404|BG001|Baseline|Intermediate Dose AAV - CNGA3|"Subretinal administration of a single intermediate dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953176|NCT03758404|BG002|Baseline|High Dose AAV - CNGA3|"Subretinal administration of a single high dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953177|NCT03758404|BG003|Baseline|Total|Total of all reporting groups
10953178|NCT03758404|FG000|Participant Flow|Low Dose AAV - CNGA3|"Subretinal administration of a single low dose adeno-associated virus AAV-CNGA3~AAV-CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953179|NCT03758404|FG001|Participant Flow|Intermediate Dose AAV - CNGA3|"Subretinal administration of a single intermediate dose adeno-associated virus AAV-CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953180|NCT03758404|FG002|Participant Flow|High Dose AAV - CNGA3|"Subretinal administration of a single high dose adeno-associated virus AAV-CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
11192313|NCT02138227|OG004|Outcome|Post-Intervention Authorization Rate(Mid-Level Autonomous Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
10953181|NCT03758404|OG000|Outcome|Low Dose AAV - CNGA3|"Subretinal administration of a single low dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953182|NCT03758404|OG001|Outcome|Intermediate Dose AAV - CNGA3|"Subretinal administration of a single intermediate dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953183|NCT03758404|OG002|Outcome|High Dose AAV - CNGA3|"Subretinal administration of a single high dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953184|NCT03758404|EG000|Reported Event|Low Dose AAV - CNGA3|"Subretinal administration of a single low dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953185|NCT03758404|EG001|Reported Event|Intermediate Dose AAV - CNGA3|"Subretinal administration of a single intermediate dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953186|NCT03758404|EG002|Reported Event|High Dose AAV - CNGA3|"Subretinal administration of a single high dose AAV - CNGA3~AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene"
10953187|NCT03698708|BG000|Baseline|CARES Intervention- 12 Sessions|"Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.~CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach."
10953188|NCT03698708|BG001|Baseline|CARES Intervention- 8 Sessions|"Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.~CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach."
10953189|NCT03698708|BG002|Baseline|Total|Total of all reporting groups
10953190|NCT03698708|FG000|Participant Flow|CARES Intervention- 12 Sessions|"Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.~CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach."
10953191|NCT03698708|FG001|Participant Flow|CARES Intervention- 8 Sessions|"Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.~CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach."
10953192|NCT03698708|OG000|Outcome|CARES Intervention- 12 Sessions|"Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.~CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach."
10953193|NCT03698708|OG001|Outcome|CARES Intervention- 8 Sessions|"Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.~CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach."
10953194|NCT03698708|EG000|Reported Event|CARES Intervention- 12 Sessions|"Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.~CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.~Children did not receive treatment and were not monitored for adverse events."
10953195|NCT03698708|EG001|Reported Event|CARES Intervention- 8 Sessions|"Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.~CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.~Children did not receive treatment and were not monitored for adverse events."
10953196|NCT03608696|BG000|Baseline|Buprenorphine|"Buprenorphine 0.075 mg ml sublingual solution~Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose < Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24~Buprenorphine: buprenorphine 0.075 mg/ml solution"
10953197|NCT03608696|FG000|Participant Flow|Buprenorphine|"Buprenorphine 0.075 mg ml sublingual solution~Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose < Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24~Buprenorphine: buprenorphine 0.075 mg/ml solution"
10953198|NCT03608696|OG000|Outcome|Buprenorphine|"Buprenorphine 0.075 mg ml sublingual solution~Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose < Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24~Buprenorphine: buprenorphine 0.075 mg/ml solution"
10953199|NCT03608696|EG000|Reported Event|Buprenorphine|"Buprenorphine 0.075 mg ml sublingual solution~Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose < Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24~Buprenorphine: buprenorphine 0.075 mg/ml solution"
10953200|NCT03606668|BG000|Baseline|People With Multiple Sclerosis (PwMS) and Chronic Pain|"Participants with MS will only be able to receive eight treatment sessions in this study group and will complete their treatment over four weeks. Two treatments sessions must be completed each week (of the four weeks) and separated by at least one day.~Participants will attend a baseline visit with assessment and training procedures and receive their first treatment immediately after all baseline assessments. Participants will then complete the remaining seven treatment sessions over four weeks. At the final treatment session, participants will repeat assessments. One week following the final treatment session, participants will be asked to return to clinic to complete assessments once more to test cumulative benefits one week following treatment end.~HTC Vive Virtual Reality (VR) system: VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others."
10953201|NCT03606668|FG000|Participant Flow|People With Multiple Sclerosis (PwMS) and Chronic Pain|"Participants with MS will only be able to receive eight treatment sessions in this study group and will complete their treatment over four weeks. Two treatments sessions must be completed each week (of the four weeks) and separated by at least one day.~Participants will attend a baseline visit with assessment and training procedures and receive their first treatment immediately after all baseline assessments. Participants will then complete the remaining seven treatment sessions over four weeks. At the final treatment session, participants will repeat assessments. One week following the final treatment session, participants will be asked to return to clinic to complete assessments once more to test cumulative benefits one week following treatment end.~HTC Vive Virtual Reality (VR) system: VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others."
10953202|NCT03606668|OG000|Outcome|People With Multiple Sclerosis (PwMS) and Chronic Pain|"Participants with MS will only be able to receive eight treatment sessions in this study group and will complete their treatment over four weeks. Two treatments sessions must be completed each week (of the four weeks) and separated by at least one day.~Participants will attend a baseline visit with assessment and training procedures and receive their first treatment immediately after all baseline assessments. Participants will then complete the remaining seven treatment sessions over four weeks. At the final treatment session, participants will repeat assessments. One week following the final treatment session, participants will be asked to return to clinic to complete assessments once more to test cumulative benefits one week following treatment end.~HTC Vive Virtual Reality (VR) system: VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others."
10963698|NCT00873821|EG001|Reported Event|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
10963699|NCT00873860|BG000|Baseline|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10963700|NCT00873860|BG001|Baseline|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10963701|NCT00873860|BG002|Baseline|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
11178533|NCT02047903|FG000|Participant Flow|Afatinib|Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
10953203|NCT03606668|EG000|Reported Event|People With Multiple Sclerosis (PwMS) and Chronic Pain|"Participants with MS will only be able to receive eight treatment sessions in this study group and will complete their treatment over four weeks. Two treatments sessions must be completed each week (of the four weeks) and separated by at least one day.~Participants will attend a baseline visit with assessment and training procedures and receive their first treatment immediately after all baseline assessments. Participants will then complete the remaining seven treatment sessions over four weeks. At the final treatment session, participants will repeat assessments. One week following the final treatment session, participants will be asked to return to clinic to complete assessments once more to test cumulative benefits one week following treatment end.~HTC Vive Virtual Reality (VR) system: VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others."
10953204|NCT03575897|BG000|Baseline|Intervention Group|"Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data).~Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)"
10953205|NCT03575897|BG001|Baseline|Control Group|"Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them.~Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)"
10953206|NCT03575897|BG002|Baseline|Total|Total of all reporting groups
10953207|NCT03575897|FG000|Participant Flow|Intervention Group|"Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data).~Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)"
10953208|NCT03575897|FG001|Participant Flow|Control Group|"Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them.~Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)"
10953209|NCT03575897|OG000|Outcome|Intervention Group|"Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data).~Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)"
10953210|NCT03575897|OG001|Outcome|Control Group|"Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them.~Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)"
10953211|NCT03575897|EG000|Reported Event|Intervention Group|"Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data).~Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)"
10953212|NCT03575897|EG001|Reported Event|Control Group|"Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them.~Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)"
10953213|NCT03343626|BG000|Baseline|Flavivirus-naïve Cohort: Placebo|Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
10953214|NCT03343626|BG001|Baseline|Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)|PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953215|NCT03343626|BG002|Baseline|Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)|PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953216|NCT03343626|BG003|Baseline|Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953217|NCT03343626|BG004|Baseline|Flavivirus-primed Cohort: Placebo|Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
10953218|NCT03343626|BG005|Baseline|Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)|PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953219|NCT03343626|BG006|Baseline|Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)|PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953220|NCT03343626|BG007|Baseline|Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953221|NCT03343626|BG008|Baseline|Total|Total of all reporting groups
10953222|NCT03343626|FG000|Participant Flow|Flavivirus-naïve Cohort: Placebo|Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
10953223|NCT03343626|FG001|Participant Flow|Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)|PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953224|NCT03343626|FG002|Participant Flow|Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)|PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953225|NCT03343626|FG003|Participant Flow|Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953226|NCT03343626|FG004|Participant Flow|Flavivirus-primed Cohort: Placebo|Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
10953227|NCT03343626|FG005|Participant Flow|Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)|PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953228|NCT03343626|FG006|Participant Flow|Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)|PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953229|NCT03343626|FG007|Participant Flow|Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953230|NCT03343626|OG000|Outcome|Flavivirus-naïve Cohort: Placebo|Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
10953231|NCT03343626|OG001|Outcome|Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)|PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953232|NCT03343626|OG002|Outcome|Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)|PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953233|NCT03343626|OG003|Outcome|Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953234|NCT03343626|OG004|Outcome|Flavivirus-primed Cohort: Placebo|Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
10953235|NCT03343626|OG005|Outcome|Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)|PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953236|NCT03343626|OG006|Outcome|Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)|PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953237|NCT03343626|OG007|Outcome|Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953238|NCT03343626|OG001|Outcome|Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953239|NCT03343626|OG002|Outcome|Flavivirus-primed Cohort: Placebo|Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
10953240|NCT03343626|OG003|Outcome|Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953241|NCT03343626|EG000|Reported Event|Flavivirus-naïve Cohort: Placebo|Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
10953242|NCT03343626|EG001|Reported Event|Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)|PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953243|NCT03343626|EG002|Reported Event|Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)|PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953244|NCT03343626|EG003|Reported Event|Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953245|NCT03343626|EG004|Reported Event|Flavivirus-primed Cohort: Placebo|Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
10953246|NCT03343626|EG005|Reported Event|Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)|PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953247|NCT03343626|EG006|Reported Event|Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)|PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953248|NCT03343626|EG007|Reported Event|Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)|PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
10953249|NCT03088930|BG000|Baseline|Neoadjuvant Treatment With Crizotinib|"Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review.~Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary."
10953250|NCT03088930|FG000|Participant Flow|Neoadjuvant Treatment With Crizotinib|"Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review.~Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary."
10953251|NCT03088930|OG000|Outcome|Neoadjuvant Treatment With Crizotinib|"Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review.~Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary."
10963702|NCT00873860|BG003|Baseline|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10953252|NCT03088930|EG000|Reported Event|Neoadjuvant Treatment With Crizotinib|"Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review.~Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary."
10953253|NCT02960204|BG000|Baseline|Emricasan (5 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.~Emricasan"
10953254|NCT02960204|BG001|Baseline|Emricasan (25 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.~Emricasan"
10953255|NCT02960204|BG002|Baseline|Emricasan (50 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.~Emricasan"
10953256|NCT02960204|BG003|Baseline|Matching Placebo|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.~Placebo"
10953257|NCT02960204|BG004|Baseline|Total|Total of all reporting groups
10953258|NCT02960204|FG000|Participant Flow|Emricasan (5 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.~Emricasan"
10953259|NCT02960204|FG001|Participant Flow|Emricasan (25 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.~Emricasan"
10953260|NCT02960204|FG002|Participant Flow|Emricasan (50 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.~Emricasan"
10953261|NCT02960204|FG003|Participant Flow|Matching Placebo|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.~Placebo"
10953262|NCT02960204|OG000|Outcome|Emricasan (5 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.~Emricasan"
10953263|NCT02960204|OG001|Outcome|Emricasan (25 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.~Emricasan"
10953264|NCT02960204|OG002|Outcome|Emricasan (50 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.~Emricasan"
10953265|NCT02960204|OG003|Outcome|Matching Placebo|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.~Placebo"
10953266|NCT02960204|EG000|Reported Event|Emricasan (5 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.~Emricasan"
11192314|NCT02138227|OG005|Outcome|Post-Authorization Rate (Mid-Level Assisted Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
10953267|NCT02960204|EG001|Reported Event|Emricasan (25 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.~Emricasan"
10953268|NCT02960204|EG002|Reported Event|Emricasan (50 mg)|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.~Emricasan"
10953269|NCT02960204|EG003|Reported Event|Matching Placebo|"Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.~Placebo"
10953270|NCT02856269|BG000|Baseline|45 mg Daily|"Participants in this arm will take a daily 45 mg dose of zinc gluconate.~Zinc gluconate: Participants will take a daily dose of zinc gluconate."
10953271|NCT02856269|BG001|Baseline|90 mg Daily|"Participants in this arm will take a daily 90 mg dose of zinc gluconate.~Zinc gluconate: Participants will take a daily dose of zinc gluconate."
10953272|NCT02856269|BG002|Baseline|Total|Total of all reporting groups
10953273|NCT02856269|FG000|Participant Flow|45 mg Daily|"Participants in this arm will take a daily 45 mg dose of zinc gluconate.~Zinc gluconate: Participants will take a daily dose of zinc gluconate."
10953274|NCT02856269|FG001|Participant Flow|90 mg Daily|"Participants in this arm will take a daily 90 mg dose of zinc gluconate.~Zinc gluconate: Participants will take a daily dose of zinc gluconate."
10953275|NCT02856269|OG000|Outcome|45 mg Daily|"Participants in this arm will take a daily 45 mg dose of zinc gluconate.~Zinc gluconate: Participants will take a daily dose of zinc gluconate."
10953276|NCT02856269|OG001|Outcome|90 mg Daily|"Participants in this arm will take a daily 90 mg dose of zinc gluconate.~Zinc gluconate: Participants will take a daily dose of zinc gluconate."
10953277|NCT02856269|EG000|Reported Event|45 mg Daily|"Participants in this arm take a daily 45 mg dose of zinc gluconate.~Participants were interviewed for side effects at baseline and at week 16."
10953278|NCT02856269|EG001|Reported Event|90 mg Daily|"Participants in this arm take a daily 90 mg dose of zinc gluconate.~Participants were interviewed for side effects at baseline and at week 16."
10953279|NCT02807363|BG000|Baseline|Leuprolide Oral Tablet, 4 mg QD (Treatment A)|"Leuprolide Oral Tablet QD: 4 mg for 28 consecutive days.~Leuprolide Oral Tablet 4-mg QD: 4-mg Leuprolide oral tablet once daily for 28 consecutive days."
10953280|NCT02807363|BG001|Baseline|Leuprolide Oral Tablet, 4 mg BID (Treatment B)|"Leuprolide Oral Tablet BID: 4 mg, 12 hours apart for 28 consecutive days.~Leuprolide Oral Tablet 4-mg BID: 4-mg oral tablet twice daily for 28 consecutive days."
10953281|NCT02807363|BG002|Baseline|Leuprolide 1 Month Depot (Treatment C)|"Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy~Leuprolide Depot: 3.75 mg intramuscular depot injection"
10953282|NCT02807363|BG003|Baseline|Leuprolide Oral Tablet, 10 mg BID (Treatment D)|"Leuprolide Oral Tablet BID: 10 mg, 12 hours apart for 28 consecutive days~Leuprolide Oral Tablet 10-mg BID: 10-mg oral tablet twice daily for 28 consecutive days."
10953283|NCT02807363|BG004|Baseline|Total|Total of all reporting groups
10953284|NCT02807363|FG000|Participant Flow|Leuprolide Oral Tablet, 4 mg QD (Treatment A)|"Leuprolide Oral Tablet QD: 4 mg for 28 consecutive days.~Leuprolide Oral Tablet 4-mg QD: 4-mg Leuprolide oral tablet once daily for 28 consecutive days."
10953285|NCT02807363|FG001|Participant Flow|Leuprolide Oral Tablet, 4 mg BID (Treatment B)|"Leuprolide Oral Tablet BID: 4 mg, 12 hours apart for 28 consecutive days.~Leuprolide Oral Tablet 4-mg BID: 4-mg oral tablet twice daily for 28 consecutive days."
10953286|NCT02807363|FG002|Participant Flow|Leuprolide 1 Month Depot (Treatment C)|"Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy~Leuprolide Depot: 3.75 mg intramuscular depot injection"
10953287|NCT02807363|FG003|Participant Flow|Leuprolide Oral Tablet, 10 mg BID (Treatment D)|"Leuprolide Oral Tablet BID: 10 mg, 12 hours apart for 28 consecutive days~Leuprolide Oral Tablet 10-mg BID: 10-mg oral tablet twice daily for 28 consecutive days."
10953288|NCT02807363|OG000|Outcome|Leuprolide Oral Tablet, 4 mg QD (Treatment A)|"Leuprolide Oral Tablet QD: 4 mg for 28 consecutive days.~Leuprolide Oral Tablet 4-mg QD: 4-mg Leuprolide oral tablet once daily for 28 consecutive days."
10953289|NCT02807363|OG001|Outcome|Leuprolide Oral Tablet, 4 mg BID (Treatment B)|"Leuprolide Oral Tablet BID: 4 mg, 12 hours apart for 28 consecutive days.~Leuprolide Oral Tablet 4-mg BID: 4-mg oral tablet twice daily for 28 consecutive days."
10953290|NCT02807363|OG002|Outcome|Leuprolide 1 Month Depot (Treatment C)|"Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy~Leuprolide Depot: 3.75 mg intramuscular depot injection"
10953291|NCT02807363|OG003|Outcome|Leuprolide Oral Tablet, 10 mg BID (Treatment D)|"Leuprolide Oral Tablet BID: 10 mg, 12 hours apart for 28 consecutive days~Leuprolide Oral Tablet 10-mg BID: 10-mg oral tablet twice daily for 28 consecutive days."
11192315|NCT02138227|OG006|Outcome|Pre-Intervention Authorization Rate (All Senior)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Senior participants are defined has having more than 36 months of experience.
10953292|NCT02807363|OG002|Outcome|Leuprolide 1 Month Depot (Treatment C)|"Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month (28 day cycle) of therapy~Leuprolide Depot: 3.75 mg intramuscular depot injection"
10953293|NCT02807363|OG002|Outcome|Leuprolide 1 Month Depot(Treatment C)|"Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy~Leuprolide Depot: 3.75 mg intramuscular depot injection"
10953294|NCT02807363|EG000|Reported Event|Leuprolide Oral Tablet, 4 mg QD (Treatment A)|"Leuprolide Oral Tablet QD: 4 mg for 28 consecutive days.~Leuprolide Oral Tablet 4-mg QD: 4-mg Leuprolide oral tablet once daily for 28 consecutive days."
10953295|NCT02807363|EG001|Reported Event|Leuprolide Oral Tablet, 4 mg BID (Treatment B)|"Leuprolide Oral Tablet BID: 4 mg, 12 hours apart for 28 consecutive days.~Leuprolide Oral Tablet 4-mg BID: 4-mg oral tablet twice daily for 28 consecutive days."
10953296|NCT02807363|EG002|Reported Event|Leuprolide 1 Month Depot (Treatment C)|"Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy~Leuprolide Depot: 3.75 mg intramuscular depot injection"
10953297|NCT02807363|EG003|Reported Event|Leuprolide Oral Tablet, 10 mg BID (Treatment D)|"Leuprolide Oral Tablet BID: 10 mg, 12 hours apart for 28 consecutive days~Leuprolide Oral Tablet 10-mg BID: 10-mg oral tablet twice daily for 28 consecutive days."
10953298|NCT02756403|BG000|Baseline|Azithromycin|"500 mg of Azithromycin~Azithromycin: 500 mg"
10953299|NCT02756403|BG001|Baseline|Doxycycline|"200 mg of Doxycycline~Doxycycline: 200 mg"
10953300|NCT02756403|BG002|Baseline|Metronidazole|"500 mg of Metronidazole~Metronidazole: 500 mg"
10953301|NCT02756403|BG003|Baseline|Placebo|"Inactive Ingredient~Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration."
10953302|NCT02756403|BG004|Baseline|Total|Total of all reporting groups
10953303|NCT02756403|FG000|Participant Flow|Azithromycin|"500 mg of Azithromycin~Azithromycin: 500 mg"
10953304|NCT02756403|FG001|Participant Flow|Doxycycline|"200 mg of Doxycycline~Doxycycline: 200 mg"
10953305|NCT02756403|FG002|Participant Flow|Metronidazole|"500 mg of Metronidazole~Metronidazole: 500 mg"
10953306|NCT02756403|FG003|Participant Flow|Placebo|"Inactive Ingredient~Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration."
10953307|NCT02756403|OG000|Outcome|Azithromycin|"500 mg of Azithromycin~Azithromycin: 500 mg"
10953308|NCT02756403|OG001|Outcome|Doxycycline|"200 mg of Doxycycline~Doxycycline: 200 mg"
10953309|NCT02756403|OG002|Outcome|Metronidazole|"500 mg of Metronidazole~Metronidazole: 500 mg"
10953310|NCT02756403|OG003|Outcome|Placebo|"Inactive Ingredient~Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration."
10953311|NCT02756403|EG000|Reported Event|Metronidazole|Patients receivingMetronidazole for preprocedure antibiotic
10953312|NCT02756403|EG001|Reported Event|Azithromycin|Patients receiving Azithromycin for preprocedure antibiotic
10953313|NCT02756403|EG002|Reported Event|Doxycycline|Patients receiving Doxycycline for preprocedure antibiotic
10953314|NCT02756403|EG003|Reported Event|Placebo|Patients receiving Placebo preprocedure
10953315|NCT02751502|BG000|Baseline|Whole Population|Data reported under one arm, as randomization into arms has not occurred yet.
10953316|NCT02751502|FG000|Participant Flow|Whole Population|Data reported under one arm, as randomization into arms has not occurred yet.
10953317|NCT02751502|OG000|Outcome|Whole Population|Data reported under one arm, as randomization into arms has not occurred yet.
10953318|NCT02751502|EG000|Reported Event|Whole Population|Data reported under one arm, as randomization into arms has not occurred yet.
10963703|NCT00873860|BG004|Baseline|Total|Total of all reporting groups
10963704|NCT00873860|FG000|Participant Flow|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10953319|NCT02487797|BG000|Baseline|High Dose Oxytocin Regimen|"The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.~Oxytocin~Sodium Chloride 0.9%"
10953320|NCT02487797|BG001|Baseline|Low Dose Oxytocin Regimen|"The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.~Oxytocin~Sodium Chloride 0.9%"
10953321|NCT02487797|BG002|Baseline|Total|Total of all reporting groups
10953322|NCT02487797|FG000|Participant Flow|High Dose Oxytocin Regimen|"The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.~Oxytocin~Sodium Chloride 0.9%"
10953323|NCT02487797|FG001|Participant Flow|Low Dose Oxytocin Regimen|"The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.~Oxytocin~Sodium Chloride 0.9%"
10953324|NCT02487797|OG000|Outcome|High Dose Oxytocin Regimen|"The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.~Oxytocin~Sodium Chloride 0.9%"
10953325|NCT02487797|OG001|Outcome|Low Dose Oxytocin Regimen|"The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.~Oxytocin~Sodium Chloride 0.9%"
10953326|NCT02487797|EG000|Reported Event|High Dose Oxytocin Regimen|"The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.~Oxytocin~Sodium Chloride 0.9%"
10953327|NCT02487797|EG001|Reported Event|Low Dose Oxytocin Regimen|"The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.~Oxytocin~Sodium Chloride 0.9%"
10953328|NCT02348359|BG000|Baseline|50 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953329|NCT02348359|BG001|Baseline|100 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953330|NCT02348359|BG002|Baseline|200 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953331|NCT02348359|BG003|Baseline|Placebo Plus Ivt Anti-VEGF Prn|"Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~Anti-VEGF~Placebo"
10953332|NCT02348359|BG004|Baseline|Total|Total of all reporting groups
10953333|NCT02348359|FG000|Participant Flow|50 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953334|NCT02348359|FG001|Participant Flow|100 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953335|NCT02348359|FG002|Participant Flow|200 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
11178534|NCT02047903|OG000|Outcome|Afatinib|Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
11357660|NCT03750955|BG000|Baseline|Plaque Induced Gingivitis|Plaque induced gingivitis resulting from a cessation of oral hygiene in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant using a stent-induced biofilm overgrowth model.
10953336|NCT02348359|FG003|Participant Flow|Placebo Plus Ivt Anti-VEGF Prn|"Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~Anti-VEGF~Placebo"
10953337|NCT02348359|OG000|Outcome|50 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953338|NCT02348359|OG001|Outcome|100 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953339|NCT02348359|OG002|Outcome|200 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953340|NCT02348359|OG003|Outcome|Placebo Plus Ivt Anti-VEGF Prn|"Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~Anti-VEGF~Placebo"
10953341|NCT02348359|EG000|Reported Event|50 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953342|NCT02348359|EG001|Reported Event|100 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953343|NCT02348359|EG002|Reported Event|200 mg of X-82 Plus Ivt Anti-VEGF Prn|"Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~X-82~Anti-VEGF"
10953344|NCT02348359|EG003|Reported Event|Placebo Plus Ivt Anti-VEGF Prn|"Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.~Anti-VEGF~Placebo"
10953345|NCT02285062|BG000|Baseline|Lenalidomide Plus R-CHOP (R2-CHOP)|Participants received lenalidomide 15 mg capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 cycles. Treatment continued until completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, whichever occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice.
10953346|NCT02285062|BG001|Baseline|Placebo Plus R-CHOP|Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice.
10953347|NCT02285062|BG002|Baseline|Total|Total of all reporting groups
10953348|NCT02285062|FG000|Participant Flow|Lenalidomide Plus R-CHOP (R2-CHOP)|Participants received lenalidomide 15 mg capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 cycles. Treatment continued until completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, whichever occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice.
10953349|NCT02285062|FG001|Participant Flow|Placebo Plus R-CHOP|Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice.
10953350|NCT02285062|OG000|Outcome|Lenalidomide Plus R-CHOP (R2-CHOP)|Participants received lenalidomide 15 mg capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 cycles. Treatment continued until completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, whichever occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice.
10963705|NCT00873860|FG001|Participant Flow|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
11178535|NCT02047903|EG000|Reported Event|Afatinib|Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
10953351|NCT02285062|OG001|Outcome|Placebo Plus R-CHOP|Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice.
10953352|NCT02285062|EG000|Reported Event|Lenalidomide Plus R-CHOP (R2-CHOP)|Participants received lenalidomide 15 mg capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 cycles. Treatment continued until completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, whichever occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice.
10953353|NCT02285062|EG001|Reported Event|Placebo Plus R-CHOP|Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice.
10953358|NCT01981096|BG000|Baseline|Fibromyalgia Integrative Training|"8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training~Fibromyalgia integrative training: Combined intervention with neuromuscular exercise training and cognitive behavioral therapy"
10953359|NCT01981096|BG001|Baseline|Cognitive Behavioral Therapy|"8 week (16 session) cognitive-behavioral therapy treatment.~Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills"
10953360|NCT01981096|BG002|Baseline|Total|Total of all reporting groups
10953361|NCT01981096|FG000|Participant Flow|Fibromyalgia Integrative Training|"8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training~Fibromyalgia integrative training: Combined intervention with neuromuscular exercise training and cognitive behavioral therapy"
10953362|NCT01981096|FG001|Participant Flow|Cognitive Behavioral Therapy|"8 week (16 session) cognitive-behavioral therapy treatment.~Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills"
10953363|NCT01981096|OG000|Outcome|Fibromyalgia Integrative Training|"8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training~Fibromyalgia integrative training: Combined intervention with neuromuscular exercise training and cognitive behavioral therapy"
11178536|NCT02047981|BG000|Baseline|Biannual Mass Oral Azithromycin|"Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.~Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.~In Niger during year 3, all communities will be offered azithroymcin.~Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin."
10953364|NCT01981096|OG001|Outcome|Cognitive Behavioral Therapy|"8 week (16 session) cognitive-behavioral therapy treatment.~Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills"
10953365|NCT01981096|EG000|Reported Event|Fibromyalgia Integrative Training|"8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training~Fibromyalgia integrative training: Combined intervention with neuromuscular exercise training and cognitive behavioral therapy"
10953366|NCT01981096|EG001|Reported Event|Cognitive Behavioral Therapy|"8 week (16 session) cognitive-behavioral therapy treatment.~Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills"
10953367|NCT01935336|BG000|Baseline|Ponatinib SISH+/ISH+|"The pre-defined cutpoint for FGFR1 amplification (SISH+) was an average of at least four FGFR1 signals per nucleus (gene copy number) or FGFR1/CEP8 ratio ≥ 2.0.~mRNA in situ hybridization (ISH) was performed on formalin-fixed paraffin embedded (FFPE) tumor tissue using the RNA scope 2.0 assay system. ISH scores were generated and recorded using the following scoring system at 200 × magnification: 0, no staining; 1, one to 3 dots per tumor cell; 2, 4 to 10 dots per tumor cell; 3, more than 10 dots per cell or presence of dot clusters in ≥1% and < 10% tumor cells; 4, ≥ 10% tumor cells with dot clusters as per the RNA scope system scoring guidelines.18 The pre-defined cutpoint for FGFR1 ISH positivity was a score of 3 or 4 per this scoring system."
10953368|NCT01935336|BG001|Baseline|Ponatinib SISH+/ISH-|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group are those with SISH positive and ISH negative."
10953369|NCT01935336|BG002|Baseline|Ponatinib SISH-/ISH+|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group with a negative SISH and a positive ISH"
10953370|NCT01935336|BG003|Baseline|Ponatinib SISH-/ISH-|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group with a negative SISH and a negative ISH"
10953371|NCT01935336|BG004|Baseline|Total|Total of all reporting groups
10953372|NCT01935336|FG000|Participant Flow|Ponatinib SISH+/ISH+|"The pre-defined cutpoint for FGFR1 amplification (SISH+) was an average of at least four FGFR1 signals per nucleus (gene copy number) or FGFR1/CEP8 ratio ≥ 2.0.~mRNA in situ hybridization (ISH) was performed on formalin-fixed paraffin embedded (FFPE) tumor tissue using the RNA scope 2.0 assay system. ISH scores were generated and recorded using the following scoring system at 200 × magnification: 0, no staining; 1, one to 3 dots per tumor cell; 2, 4 to 10 dots per tumor cell; 3, more than 10 dots per cell or presence of dot clusters in ≥1% and < 10% tumor cells; 4, ≥ 10% tumor cells with dot clusters as per the RNA scope system scoring guidelines.18 The pre-defined cutpoint for FGFR1 ISH positivity was a score of 3 or 4 per this scoring system."
10953373|NCT01935336|FG001|Participant Flow|Ponatinib SISH+/ISH-|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group are those with SISH positive and ISH negative."
10953374|NCT01935336|FG002|Participant Flow|Ponatinib SISH-/ISH+|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group with a negative SISH and a positive ISH"
10953375|NCT01935336|FG003|Participant Flow|Ponatinib SISH-/ISH-|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group with a negative SISH and a negative ISH"
10953376|NCT01935336|OG000|Outcome|SISH-|Less than four FGFR1 signals per nucleus (gene copy number) or FGFR1/CEP8 ratio ≥ 2.0
10953377|NCT01935336|OG001|Outcome|SISH+|At least four FGFR1 signals per nucleus (gene copy number) or FGFR1/CEP8 ratio ≥ 2.0
10953378|NCT01935336|OG002|Outcome|ISH-(<1%)|mRNA in situ hybridization with dot clusters per tumor <1%
10953379|NCT01935336|OG003|Outcome|ISH+(>=1%)|mRNA in situ hybridization with dot clusters 1%=<per tumor <10%
10953380|NCT01935336|OG004|Outcome|ISH<20%|mRNA in situ hybridization with dot clusters 10%=<per tumor <20%
10953381|NCT01935336|OG005|Outcome|ISH>=20%|mRNA in situ hybridization with dot clusters 1per tumor >=20%
10953382|NCT01935336|OG000|Outcome|Ponatinib SISH+/ISH+|"The pre-defined cutpoint for FGFR1 amplification (SISH+) was an average of at least four FGFR1 signals per nucleus (gene copy number) or FGFR1/CEP8 ratio ≥ 2.0.~mRNA in situ hybridization (ISH) was performed on formalin-fixed paraffin embedded (FFPE) tumor tissue using the RNA scope 2.0 assay system. ISH scores were generated and recorded using the following scoring system at 200 × magnification: 0, no staining; 1, one to 3 dots per tumor cell; 2, 4 to 10 dots per tumor cell; 3, more than 10 dots per cell or presence of dot clusters in ≥1% and < 10% tumor cells; 4, ≥ 10% tumor cells with dot clusters as per the RNA scope system scoring guidelines.18 The pre-defined cutpoint for FGFR1 ISH positivity was a score of 3 or 4 per this scoring system."
10953383|NCT01935336|OG001|Outcome|Ponatinib SISH+/ISH-|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group are those with SISH positive and ISH negative."
10953384|NCT01935336|OG002|Outcome|Ponatinib SISH-/ISH+|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group with a negative SISH and a positive ISH"
10953385|NCT01935336|OG003|Outcome|Ponatinib SISH-/ISH-|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group with a negative SISH and a negative ISH"
10953386|NCT01935336|EG000|Reported Event|Ponatinib SISH+/ISH+|"The pre-defined cutpoint for FGFR1 amplification (SISH+) was an average of at least four FGFR1 signals per nucleus (gene copy number) or FGFR1/CEP8 ratio ≥ 2.0.~mRNA in situ hybridization (ISH) was performed on formalin-fixed paraffin embedded (FFPE) tumor tissue using the RNA scope 2.0 assay system. ISH scores were generated and recorded using the following scoring system at 200 × magnification: 0, no staining; 1, one to 3 dots per tumor cell; 2, 4 to 10 dots per tumor cell; 3, more than 10 dots per cell or presence of dot clusters in ≥1% and < 10% tumor cells; 4, ≥ 10% tumor cells with dot clusters as per the RNA scope system scoring guidelines.18 The pre-defined cutpoint for FGFR1 ISH positivity was a score of 3 or 4 per this scoring system."
10953387|NCT01935336|EG001|Reported Event|Ponatinib SISH+/ISH-|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group are those with SISH positive and ISH negative."
10953388|NCT01935336|EG002|Reported Event|Ponatinib SISH-/ISH+|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group with a negative SISH and a positive ISH"
10953389|NCT01935336|EG003|Reported Event|Ponatinib SISH-/ISH-|"Please see details in Ponatinib SISH+/ISH+ for the definition of SISH positivity and ISH positivity.~Subjects in this group with a negative SISH and a negative ISH"
10953390|NCT01712490|BG000|Baseline|A+AVD|Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
10953391|NCT01712490|BG001|Baseline|ABVD|Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
10953392|NCT01712490|BG002|Baseline|Total|Total of all reporting groups
10963706|NCT00873860|FG002|Participant Flow|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10963707|NCT00873860|FG003|Participant Flow|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10953393|NCT01712490|FG000|Participant Flow|A+AVD|Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
10953394|NCT01712490|FG001|Participant Flow|ABVD|Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
10953395|NCT01712490|OG000|Outcome|A+AVD|Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
10953396|NCT01712490|OG001|Outcome|ABVD|Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
10953397|NCT01712490|EG000|Reported Event|A+AVD|Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
10953398|NCT01712490|EG001|Reported Event|ABVD|Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
10953399|NCT01702805|BG000|Baseline|High Transfusion Threshold|Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group.
10953400|NCT01702805|BG001|Baseline|Low Transfusion Threshold|Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C
10953401|NCT01702805|BG002|Baseline|Total|Total of all reporting groups
10953402|NCT01702805|FG000|Participant Flow|High Tranfusion Threshold|"Transfusions were administered using a higher threshold hemoglobin value. AKA Liberal Cell Transfusion group."
11357661|NCT03750955|BG001|Baseline|Oral Hygiene Maintenance|Oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant.
11357662|NCT03750955|BG002|Baseline|Total|Total of all reporting groups
10953403|NCT01702805|FG001|Participant Flow|Low Transfusion Threshold|"Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA Restricted Red Cell Transfusion group."
10953404|NCT01702805|OG000|Outcome|High Transfusion Threshold|Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group.
10953405|NCT01702805|OG001|Outcome|Low Transfusion Threshold|Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C
10953406|NCT01702805|EG000|Reported Event|High Tranfusion Threshold|"Transfusions were administered using a higher threshold hemoglobin value. AKA Liberal Cell Transfusion group."
10953407|NCT01702805|EG001|Reported Event|Low Transfusion Threshold|"Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA Restricted Red Cell Transfusion group."
10953408|NCT01499160|BG000|Baseline|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
10953409|NCT01499160|FG000|Participant Flow|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
10953410|NCT01499160|OG000|Outcome|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue-2 subjects Group 2: HER2 negative in the tumor tissue-5 subjects~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
10963708|NCT00873860|OG000|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10953411|NCT01499160|OG000|Outcome|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
10953412|NCT01499160|EG000|Reported Event|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
10953413|NCT01333436|BG000|Baseline|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein.
10953414|NCT01333436|BG001|Baseline|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal ( 57% fat, 31% carbohydrate, and 12% protein).
10953415|NCT01333436|BG002|Baseline|Total|Total of all reporting groups
10953416|NCT01333436|FG000|Participant Flow|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
10963709|NCT00873860|OG001|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
11178537|NCT02047981|BG001|Baseline|Biannual Mass Oral Placebo|"Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.~Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years~In Niger during year 3, all communities will be offered azithroymcin.~Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin."
11178538|NCT02047981|BG002|Baseline|Total|Total of all reporting groups
11178539|NCT02047981|FG000|Participant Flow|Biannual Mass Oral Azithromycin|"Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.~Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.~In Niger during year 3, all communities will be offered azithroymcin.~Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin."
11178540|NCT02047981|FG001|Participant Flow|Biannual Mass Oral Placebo|"Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.~Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years~In Niger during year 3, all communities will be offered azithroymcin.~Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin."
11178541|NCT02047981|OG000|Outcome|Biannual Mass Oral Azithromycin|"Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.~Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.~In Niger during year 3, all communities will be offered azithroymcin.~Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin."
11178542|NCT02047981|OG001|Outcome|Biannual Mass Oral Placebo|"Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.~Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years~In Niger during year 3, all communities will be offered azithroymcin.~Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin."
11178543|NCT02047981|EG000|Reported Event|Biannual Mass Oral Azithromycin|"Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.~Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.~In Niger during year 3, all communities will be offered azithroymcin.~Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin."
11178544|NCT02047981|EG001|Reported Event|Biannual Mass Oral Placebo|"Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.~Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years~In Niger during year 3, all communities will be offered azithroymcin.~Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin."
10953417|NCT01333436|FG001|Participant Flow|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
10953418|NCT01333436|OG000|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
10953419|NCT01333436|OG001|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
10953420|NCT01333436|EG000|Reported Event|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
11178545|NCT02048072|BG000|Baseline|Gilenya|Gilenya 0.5mg p.o. once daily
11178546|NCT02048072|FG000|Participant Flow|Gilenya|Gilenya 0.5mg p.o. once daily
11178547|NCT02048072|OG000|Outcome|Gilenya|Gilenya 0.5mg p.o. once daily
11178548|NCT02048072|EG000|Reported Event|Gilenya|Gilenya 0.5mg p.o. once daily
11178549|NCT02048241|BG000|Baseline|Placebo Plus Parent Management Training|"Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Placebo: Weekly dispensation of pills matching Intuniv but without the active medication"
10953421|NCT01333436|EG001|Reported Event|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
10953422|NCT01307631|BG000|Baseline|Treatment (Akt Inhibitor MK2206|"Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11178550|NCT02048241|BG001|Baseline|Intuniv Plus Parent Management Training|"Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Intuniv: Weekly administration of medication in doses as per protocol"
11178551|NCT02048241|BG002|Baseline|Total|Total of all reporting groups
11178552|NCT02048241|FG000|Participant Flow|Placebo Plus Parent Management Training|"Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Placebo: Weekly dispensation of pills matching Intuniv but without the active medication"
11178553|NCT02048241|FG001|Participant Flow|Intuniv Plus Parent Management Training|"Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Intuniv: Weekly administration of medication in doses as per protocol"
11178554|NCT02048241|OG000|Outcome|Placebo Plus Parent Management Training|"Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Placebo: Weekly dispensation of pills matching Intuniv but without the active medication"
10963710|NCT00873860|OG002|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
11178555|NCT02048241|OG001|Outcome|Intuniv Plus Parent Management Training|"Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Intuniv: Weekly administration of medication in doses as per protocol"
11178556|NCT02048241|EG000|Reported Event|Placebo Plus Parent Management Training|"Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Placebo: Weekly dispensation of pills matching Intuniv but without the active medication"
11178557|NCT02048241|EG001|Reported Event|Intuniv Plus Parent Management Training|"Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Intuniv: Weekly administration of medication in doses as per protocol"
11178558|NCT02048670|BG000|Baseline|Chronic Subjective Dizziness Syndrome Subjects|Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
11178559|NCT02048670|BG001|Baseline|Healthy Subjects|Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.
11178560|NCT02048670|BG002|Baseline|Total|Total of all reporting groups
11178561|NCT02048670|FG000|Participant Flow|Chronic Subjective Dizziness Syndrome Subjects|Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
10953423|NCT01307631|FG000|Participant Flow|Treatment (Akt Inhibitor MK2206) PIK3CA Mutation|"Patients with PIK3CA mutation receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10953424|NCT01307631|FG001|Participant Flow|Treatment (Akt Inhibitor MK2206) Wild Type|"Patients with wild type receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10953425|NCT01307631|OG000|Outcome|Treatment (Akt Inhibitor MK2206|"Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10953426|NCT01307631|OG000|Outcome|Treatment (Akt Inhibitor MK2206) PIK3CA Mutation|"Patients with PIK3CA mutation receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10953427|NCT01307631|OG001|Outcome|Treatment (Akt Inhibitor MK2206) Wild Type|"Patients with wild type receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10953428|NCT01307631|EG000|Reported Event|Treatment (Akt Inhibitor MK2206|"Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10953429|NCT01256086|BG000|Baseline|N1A2A1N2|Sequence 1: N1A2A1N2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
10953430|NCT01256086|BG001|Baseline|A1N1N2A2|Sequence 2: A1N1N2A2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
10953431|NCT01256086|BG002|Baseline|N2A1A2N1|Sequence 3: N2A1A2N1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
10953432|NCT01256086|BG003|Baseline|A2N2N1A1|Sequence 4: A2N2N1A1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
10953433|NCT01256086|BG004|Baseline|Total|Total of all reporting groups
10953434|NCT01256086|FG000|Participant Flow|N1A2A1N2|Treatment sequence 12 µg Novolizer - 24 µg Aerolizer - 12 µg Aerolizer - 24 µg Novolizer
11178562|NCT02048670|FG001|Participant Flow|Healthy Subjects|Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.
10953435|NCT01256086|FG001|Participant Flow|A1N1N2A2|Treatment sequence 12 µg Aerolizer - 12 µg Novolizer - 24 µg Novolizer - 24 µg Aerolizer
10953436|NCT01256086|FG002|Participant Flow|N2A1A2N1|Treatment sequence 24 µg Novolizer - 12 µg Aerolizer - 24 µg Aerolizer - 12 µg Novolizer
10953437|NCT01256086|FG003|Participant Flow|A2N2N1A1|Treatment sequence 24 µg Aerolizer - 24 µg Novolizer - 12 µg Novolizer - 12 µg Aerolizer
10953438|NCT01256086|OG000|Outcome|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
10953439|NCT01256086|OG001|Outcome|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
10953440|NCT01256086|OG002|Outcome|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
10953441|NCT01256086|OG003|Outcome|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
10953442|NCT01256086|EG000|Reported Event|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
10953443|NCT01256086|EG001|Reported Event|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
10953444|NCT01256086|EG002|Reported Event|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
10953445|NCT01256086|EG003|Reported Event|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
10953446|NCT01061151|BG000|Baseline|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV tail
10953447|NCT01061151|BG001|Baseline|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
10953448|NCT01061151|BG002|Baseline|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
10953449|NCT01061151|BG003|Baseline|Late Presenters|Registrational component to assess entry criteria for possible randomization in the Postpartum Component
10953450|NCT01061151|BG004|Baseline|Total|Total of all reporting groups
10953451|NCT01061151|FG000|Participant Flow|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV tail
10953452|NCT01061151|FG001|Participant Flow|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
10953453|NCT01061151|FG002|Participant Flow|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
10953454|NCT01061151|FG003|Participant Flow|Late Presenters|Registrational component to assess entry criteria for possible randomization in the Postpartum Component
10953455|NCT01061151|OG000|Outcome|Antepartum Arm A|Mothers Received ZDV+sdNVP+TRV Tail
10953456|NCT01061151|OG001|Outcome|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
11178563|NCT02048670|OG000|Outcome|Chronic Subjective Dizziness Syndrome Subjects|Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
11178564|NCT02048670|OG001|Outcome|Healthy Subjects|Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.
11178565|NCT02048670|EG000|Reported Event|Chronic Subjective Dizziness Syndrome Subjects|Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
10953457|NCT01061151|OG002|Outcome|Antepartum Arm C|Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
10953458|NCT01061151|OG000|Outcome|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV Tail
10953459|NCT01061151|OG002|Outcome|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
10953460|NCT01061151|OG000|Outcome|Postpartum Arm A (Maternal Prophylaxis)|Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
10953461|NCT01061151|OG001|Outcome|Postpartum Arm B (Infant Prophylaxis)|Infants received extended NVP.
10953462|NCT01061151|OG000|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
10953463|NCT01061151|OG001|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
10953464|NCT01061151|OG000|Outcome|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV tail
10953465|NCT01061151|EG000|Reported Event|Mother, (AP) ZDV+sdNVP+TRV Tail|Mothers received ZDV+sdNVP+TRV tail
10953466|NCT01061151|EG001|Reported Event|Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV)|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
10953467|NCT01061151|EG002|Reported Event|Mother, (AP) Triple ARV (FTC-TDF/LPV-RTV)|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
10953468|NCT01061151|EG003|Reported Event|Mother, LP|Registrational component to assess entry criteria for possible randomization in the Postpartum Component
10953469|NCT01061151|EG004|Reported Event|Infant, (Mother Received ZDV+sdNVP+TRV Tail)|Mothers received ZDV+sdNVP+TRV tail
10953470|NCT01061151|EG005|Reported Event|Infant, (Mother Received Triple ARV (3TC-ZDV/LPV-RTV))|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
10953471|NCT01061151|EG006|Reported Event|Infant, (Mother Received Triple ARV (FTC-TDF/LPV-RTV))|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
10953472|NCT01061151|EG007|Reported Event|Infant, LP|Registrational component to assess entry criteria for possible randomization in the Postpartum Component
10953473|NCT00981058|BG000|Baseline|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
10953474|NCT00981058|BG001|Baseline|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
10953475|NCT00981058|BG002|Baseline|Total|Total of all reporting groups
10953476|NCT00981058|FG000|Participant Flow|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
10953477|NCT00981058|FG001|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
10953478|NCT00981058|OG000|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
10953479|NCT00981058|OG001|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
10953480|NCT00981058|EG000|Reported Event|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
11178566|NCT02048670|EG001|Reported Event|Healthy Subjects|Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance
10953481|NCT00981058|EG001|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
10953482|NCT00885495|BG000|Baseline|B-Darunavir+Ritonavir Initial Arm|Darunavir+ritonavir x 7 days; Rosuvastatin x 7 days; Combination x 7 days
11178567|NCT02048826|BG000|Baseline|FINGER I|"Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program~FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I~FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II"
10953483|NCT00885495|BG001|Baseline|A-Rosuvastatin Initial Arm|Rosuvastatin x 7 days; darunavir+ritonavir x 7 days; Combination x 7 days
10953484|NCT00885495|BG002|Baseline|Total|Total of all reporting groups
10953485|NCT00885495|FG000|Participant Flow|B-Darunavir+Ritonavir Initial Arm|Darunavir+ritonavir x 7 days; Rosuvastatin x 7 days; Combination x 7 days
10953486|NCT00885495|FG001|Participant Flow|A-Rosuvastatin Initial Arm|Rosuvastatin x 7 days; darunavir+ritonavir x 7 days; Combination x 7 days
10953487|NCT00885495|OG000|Outcome|Rosuvastatin|Rosuvastatin 10 mg daily for 7 days.
10953488|NCT00885495|OG001|Outcome|Rosuvastatin-Darunavir-Ritonavir|Rosuvastatin 10 mg daily, Darunavir 600 mg and Ritonavir 100 mg twice daily for 7 days
10953489|NCT00885495|OG000|Outcome|Darunavir/Ritonavir+Rosuvastatin|Combination of all three medications
10953490|NCT00885495|OG000|Outcome|Rosuvastatin Alone|LDL values with rosuvastatin administration
10953491|NCT00885495|OG001|Outcome|Darunavir/Ritonavir|LDL values with darunavir/ritonavir administration
10953492|NCT00885495|OG002|Outcome|Rosuvastatin+Darunavir/Ritonavir|LDL values with all three medications
10953493|NCT00885495|EG000|Reported Event|Darunavir+Ritonavir|Darunavir 600 mg and ritonavir 100 mg twice daily x 7 days
10953494|NCT00885495|EG001|Reported Event|Rosuvastatin|Rosuvastatin 10 mg daily x 7 days
10953495|NCT00885495|EG002|Reported Event|Darunavir, Ritonavir and Rosuvastatin|Darunavir 600 mg and Ritonavir 100 mg twice daily with Rosuvastatin 10 mg daily x 7 days
10953496|NCT00084799|BG000|Baseline|hu3S193 10 mg/m2|Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
10953497|NCT00084799|BG001|Baseline|hu3S193 20 mg/m2|Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
10953498|NCT00084799|BG002|Baseline|Total|Total of all reporting groups
10953499|NCT00084799|FG000|Participant Flow|hu3S193 10 mg/m2|Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
10953500|NCT00084799|FG001|Participant Flow|hu3S193 20 mg/m2|Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
10953501|NCT00084799|OG000|Outcome|hu3S193 10 mg/m2|Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
10953502|NCT00084799|OG001|Outcome|hu3S193 20 mg/m2|Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
10953503|NCT00084799|EG000|Reported Event|hu3S193 10 mg/m2|Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
10953504|NCT00084799|EG001|Reported Event|hu3S193 20 mg/m2|Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 mCi of indium-111 (111In).
10953505|NCT00821236|BG000|Baseline|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
10953506|NCT00821236|BG001|Baseline|AMO/VISX CustomVue|AMO/VISX CustomVue™
10953507|NCT00821236|BG002|Baseline|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
10953508|NCT00821236|BG003|Baseline|Total|Total of all reporting groups
10953509|NCT00821236|FG000|Participant Flow|Lasik for Treatment of Nearsightedness|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment
10953510|NCT00821236|OG000|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
10953511|NCT00821236|OG001|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
10953512|NCT00821236|OG002|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
10953513|NCT00821236|EG000|Reported Event|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
10953514|NCT00821236|EG001|Reported Event|AMO/VISX CustomVue|AMO/VISX CustomVue™
10953515|NCT00821236|EG002|Reported Event|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
10953516|NCT00821327|BG000|Baseline|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
10953517|NCT00821327|FG000|Participant Flow|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
10953518|NCT00821327|OG000|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
10953519|NCT00821327|EG000|Reported Event|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
10963711|NCT00873860|OG003|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10963712|NCT00873860|OG000|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10953520|NCT00821431|BG000|Baseline|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
10953521|NCT00821431|BG001|Baseline|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
10953522|NCT00821431|BG002|Baseline|Total|Total of all reporting groups
10953523|NCT00821431|FG000|Participant Flow|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
10953524|NCT00821431|FG001|Participant Flow|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
10953525|NCT00821431|OG000|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
10953526|NCT00821431|OG001|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
10953527|NCT00821431|EG000|Reported Event|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
10953528|NCT00821431|EG001|Reported Event|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
10953529|NCT00821509|BG000|Baseline|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
10953530|NCT00821509|BG001|Baseline|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
10953531|NCT00821509|BG002|Baseline|Control|No change in hygiene behaviour
10953532|NCT00821509|BG003|Baseline|Total|Total of all reporting groups
10953533|NCT00821509|FG000|Participant Flow|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
11178568|NCT02048826|BG001|Baseline|FINGER II|"Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program~FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I~FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II"
11178569|NCT02048826|BG002|Baseline|Total|Total of all reporting groups
10953534|NCT00821509|FG001|Participant Flow|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
10953535|NCT00821509|FG002|Participant Flow|Control|No change in hygiene behaviour
10953536|NCT00821509|OG000|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
10953537|NCT00821509|OG001|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
10953538|NCT00821509|OG002|Outcome|Control|Participants were advised not to change their hand hygiene habits
10953539|NCT00821509|EG000|Reported Event|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
10953540|NCT00821509|EG001|Reported Event|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
10953541|NCT00821509|EG002|Reported Event|Control|No change in hygiene behaviour
10953542|NCT00821626|BG000|Baseline|Rapid Test|Returning travelers with fever will have a rapid flu test BD Directigen EZ Flu A+B done on a naso-pharyngeal swab
10953543|NCT00821626|BG001|Baseline|Comparator|Returning travelers with fever will benefit of the usual medical care, without rapid flu test
10953544|NCT00821626|BG002|Baseline|Total|Total of all reporting groups
10953545|NCT00821626|FG000|Participant Flow|Rapid Test|Returning travelers with fever will have a rapid flu test BD Directigen EZ Flu A+B done on a a naso-pharyngeal swab
10953546|NCT00821626|FG001|Participant Flow|Comparator|Returning travelers with fever will benefit of the usual medical care, without rapid flu test
10953547|NCT00821626|OG000|Outcome|Rapid Test|Returning travelers with fever will have a rapid flu test (BD Directigen EZ Flu A+B) on a naso-pharyngeal swab
10953548|NCT00821626|OG001|Outcome|Comparator|Returning travelers with fever will benefit of the usual medical care, without rapid flu test
10953549|NCT00821626|OG000|Outcome|Rapid Test|Returning travelers with fever will have a rapid flu test BD Directigen EZ Flu A+B done on a naso-pharyngeal swab
10953550|NCT00821626|OG000|Outcome|Rapid Test|Returning travelers with fever will have a rapid flu test BD Directigen EZ Flu A+B done on a a naso-pharyngeal swab
10953551|NCT00821626|EG000|Reported Event|Rapid Test|Returning travelers with fever will have a rapid flu test (BD Directigen EZ Flu A+B) on a naso-pharyngeal swab
10953552|NCT00821626|EG001|Reported Event|Comparator|Returning travelers with fever will benefit of the usual medical care, without rapid flu test
10953553|NCT00821678|BG000|Baseline|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
10953554|NCT00821678|BG001|Baseline|Arm 2 Treatment as Usual|Treatment as usual
10953555|NCT00821678|BG002|Baseline|Total|Total of all reporting groups
10953556|NCT00821678|FG000|Participant Flow|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
10953557|NCT00821678|FG001|Participant Flow|Arm 2 Treatment as Usual|Treatment as usual
10953558|NCT00821678|OG000|Outcome|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
10953559|NCT00821678|OG001|Outcome|Arm 2 Treatment as Usual|Treatment as usual
10953560|NCT00821678|OG000|Outcome|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The intervention involves an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and uses telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager educates/activates patients, identifies preferences, overcomes treatment barriers, monitors symptoms, side-effects and adherence, identifies psychiatric comorbidities, and encourages patient self-management. Tele-pharmacists provide medication management by phone. Tele-psychologists provide Cognitive Processing Therapy via interactive video. Tele-psychiatrists supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
10953561|NCT00821678|OG001|Outcome|Arm 2 Treatment as Usual|Usual Care
10953562|NCT00821678|EG000|Reported Event|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
10953563|NCT00821678|EG001|Reported Event|Arm 2 Treatment as Usual|Treatment as usual
10953564|NCT00821795|BG000|Baseline|NPH/Regular 70/30 Mix|"transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness~NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration"
10953565|NCT00821795|BG001|Baseline|Aspart Insulin Analog Biphasic Mix|"transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness~insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks"
10953566|NCT00821795|BG002|Baseline|Total|Total of all reporting groups
10953567|NCT00821795|FG000|Participant Flow|NPH/Regular 70/30 Mix|"transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness~NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration"
10953568|NCT00821795|FG001|Participant Flow|Aspart Insulin Analog Biphasic Mix|"transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness~insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks"
10953569|NCT00821795|OG000|Outcome|NPH/Regular 70/30 Mix|"transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness~NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration"
10953570|NCT00821795|OG001|Outcome|Aspart Insulin Analog Biphasic Mix|"transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness~insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks"
10953571|NCT00821795|EG000|Reported Event|NPH/Regular 70/30 Mix|"transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness~NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration"
10953572|NCT00821795|EG001|Reported Event|Aspart Insulin Analog Biphasic Mix|"transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness~insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks"
10953573|NCT00821821|BG000|Baseline|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
10953574|NCT00821821|BG001|Baseline|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
11357663|NCT03750955|FG000|Participant Flow|Plaque Induced Gingivitis|Plaque induced gingivitis resulting from a cessation of oral hygiene in maxillary sextant right (teeth #5 to #8) or left (#9 to #12) using a stent-induced biofilm overgrowth (SIBO) model.
10953575|NCT00821821|BG002|Baseline|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
10953576|NCT00821821|BG003|Baseline|Total|Total of all reporting groups
10953577|NCT00821821|FG000|Participant Flow|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
10953578|NCT00821821|FG001|Participant Flow|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
10953579|NCT00821821|FG002|Participant Flow|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
10953580|NCT00821821|OG000|Outcome|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
10953581|NCT00821821|OG001|Outcome|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
10953582|NCT00821821|OG002|Outcome|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
10953583|NCT00821821|OG000|Outcome|MCI-186 Cohort1|Edaravone:circa 1000mg / 72-hour infusion
10953584|NCT00821821|OG001|Outcome|MCI-186 Cohort2|Edaravone:circa 2000mg / 72-hour infusion
10953585|NCT00821821|EG000|Reported Event|MCI-186 Cohort1|Edaravone: circa 1000mg / 72-hour infusion
10953586|NCT00821821|EG001|Reported Event|MCI-186 Cohort2|Edaravone: circa 2000mg / 72-hour infusion
10953587|NCT00821821|EG002|Reported Event|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
10953588|NCT00821873|BG000|Baseline|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
10953589|NCT00821873|FG000|Participant Flow|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
10953590|NCT00821873|OG000|Outcome|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
10953591|NCT00821873|EG000|Reported Event|Adverse Events|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
10963713|NCT00873860|OG001|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10963714|NCT00873860|OG002|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10963715|NCT00873860|EG000|Reported Event|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
11178570|NCT02048826|FG000|Participant Flow|FINGER I|"Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program~FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I~FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II~FINGER III: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III"
11178571|NCT02048826|FG001|Participant Flow|FINGER II|"Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program~FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I~FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II~FINGER III: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III"
11178572|NCT02048826|OG000|Outcome|FINGER I|"Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program~FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I~FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II"
11178573|NCT02048826|OG001|Outcome|FINGER II|"Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program~FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I~FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II"
11178574|NCT02048826|EG000|Reported Event|FINGER I|"Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program~FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I~FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II"
10953592|NCT00821886|BG000|Baseline|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
10953593|NCT00821886|FG000|Participant Flow|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
10953594|NCT00821886|OG000|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
11178575|NCT02048826|EG001|Reported Event|FINGER II|"Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program~FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I~FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II"
11192316|NCT02138227|OG007|Outcome|Post-Intervention Authorization Rate (Senior Autonomous Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Senior participants are defined has having more than 36 months of experience.
10953595|NCT00821886|EG000|Reported Event|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
10953596|NCT00821951|BG000|Baseline|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
10953597|NCT00821951|FG000|Participant Flow|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
10953598|NCT00821951|OG000|Outcome|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
10953599|NCT00821951|EG000|Reported Event|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
10953600|NCT00821964|BG000|Baseline|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
10953601|NCT00821964|FG000|Participant Flow|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
11178576|NCT02048878|BG000|Baseline|Insomnia Group|"Assessment of physiologic hyper-arousal across the two following domains:~Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.~Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis."
10953602|NCT00821964|OG000|Outcome|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
10953603|NCT00821964|OG000|Outcome|HER2, IGFBP-2, MAGE3, TopoIIa Antigen - Baseline to Week 13|Precursor frequency of HER2, IGFBP-2, MAGE3, Topo II-alpha antigens between baseline to Week 13
10953604|NCT00821964|OG001|Outcome|HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24|Precursor frequency of HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
10953605|NCT00821964|OG000|Outcome|Incidence of Reduction of TGF-beta Levels|Incidence of reduction of serum TGF-beta levels assessed by ELISA of at least 25% from baseline to week 13
10953606|NCT00821964|EG000|Reported Event|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
10953607|NCT00822094|BG000|Baseline|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
10953608|NCT00822094|BG001|Baseline|Salvage Therapy|First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
10953609|NCT00822094|BG002|Baseline|Total|Total of all reporting groups
10953610|NCT00822094|FG000|Participant Flow|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
10953611|NCT00822094|FG001|Participant Flow|Salvage Therapy|First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
10963716|NCT00873860|EG001|Reported Event|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10953612|NCT00822094|OG000|Outcome|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
10953613|NCT00822094|OG001|Outcome|Salvage Therapy|First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
10953614|NCT00822094|EG000|Reported Event|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
10953615|NCT00822094|EG001|Reported Event|Salvage Therapy|First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
10953616|NCT00822107|BG000|Baseline|Thiazide Response|"Hydrochlorothiazide 50 mg will be administered by mouth once.~Hydrochlorothiazide: 50 mg one time"
10953617|NCT00822107|FG000|Participant Flow|Thiazide Response|"Hydrochlorothiazide 50 mg will be administered by mouth once.~Hydrochlorothiazide: 50 mg one time"
10953618|NCT00822107|OG000|Outcome|Thiazide Response|"Hydrochlorothiazide 50 mg will be administered by mouth once.~Hydrochlorothiazide: 50 mg one time"
10953619|NCT00822107|EG000|Reported Event|Thiazide Response|"Hydrochlorothiazide 50 mg will be administered by mouth once.~Hydrochlorothiazide: 50 mg one time"
10953620|NCT00822172|BG000|Baseline|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
10953621|NCT00822172|BG001|Baseline|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
10953622|NCT00822172|BG002|Baseline|Total|Total of all reporting groups
10953623|NCT00822172|FG000|Participant Flow|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
11178577|NCT02048878|BG001|Baseline|Matched Control Group|"Assessment of physiologic hyper-arousal across the two following domains:~Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.~Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis."
10953624|NCT00822172|FG001|Participant Flow|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
10953625|NCT00822172|OG000|Outcome|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
10953626|NCT00822172|OG001|Outcome|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
10953627|NCT00822172|EG000|Reported Event|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
10953628|NCT00822172|EG001|Reported Event|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
10953629|NCT00822185|BG000|Baseline|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
10953630|NCT00822185|BG001|Baseline|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
10953631|NCT00822185|BG002|Baseline|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
11178578|NCT02048878|BG002|Baseline|Total|Total of all reporting groups
11192317|NCT02138227|OG008|Outcome|Post-Authorization Rate (Senior Assisted Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Senior participants are defined has having more than 36 months of experience.
10953632|NCT00822185|BG003|Baseline|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
10953633|NCT00822185|BG004|Baseline|Placebo|A single dose of placebo was administered intravenously
11234340|NCT02433977|BG000|Baseline|Conjugated Linolenic Acid + NOx|"This is a single arm study~Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day~Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg)~Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)~Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day~Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)~Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)"
11234341|NCT02433977|FG000|Participant Flow|Conjugated Linolenic Acid + NOx|"This is a single arm study~Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day~Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg)~Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)~Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day~Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)~Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)"
11234342|NCT02433977|OG000|Outcome|Conjugated Linolenic Acid + NOx|"This is a single arm study~Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day~Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg)~Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)~Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day~Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)~Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)"
11234343|NCT02433977|EG000|Reported Event|Conjugated Linolenic Acid + NOx|"This is a single arm study~Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day~Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg)~Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)~Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day~Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)~Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)"
11234344|NCT02434081|BG000|Baseline|Concurrent CRT-Nivo|"4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.~Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation."
11234345|NCT02434081|FG000|Participant Flow|Concurrent CRT-Nivo|"4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.~Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation."
11234346|NCT02434081|OG000|Outcome|Chemo-radiotherapy With Concurrent Nivolumab|"4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.~Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation."
11357664|NCT03750955|FG001|Participant Flow|Oral Hygiene Maintenance|Oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant.
10953634|NCT00822185|BG005|Baseline|Total|Total of all reporting groups
10953635|NCT00822185|FG000|Participant Flow|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
10953636|NCT00822185|FG001|Participant Flow|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
10953637|NCT00822185|FG002|Participant Flow|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
10953638|NCT00822185|FG003|Participant Flow|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
10953639|NCT00822185|FG004|Participant Flow|Placebo|A single dose of placebo was administered intravenously
10953640|NCT00822185|OG000|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
10953641|NCT00822185|OG001|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
10953642|NCT00822185|OG002|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
10953643|NCT00822185|OG003|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
10953644|NCT00822185|OG004|Outcome|Placebo|A single dose of placebo was administered intravenously
10953645|NCT00822185|EG000|Reported Event|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
10953646|NCT00822185|EG001|Reported Event|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
10953647|NCT00822185|EG002|Reported Event|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
10953648|NCT00822185|EG003|Reported Event|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
10953649|NCT00822185|EG004|Reported Event|Placebo|A single dose of placebo was administered intravenously
10953650|NCT00822237|BG000|Baseline|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
10953651|NCT00822237|BG001|Baseline|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
10953652|NCT00822237|BG002|Baseline|Total|Total of all reporting groups
10953653|NCT00822237|FG000|Participant Flow|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
10953654|NCT00822237|FG001|Participant Flow|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
10953655|NCT00822237|OG000|Outcome|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
10953656|NCT00822237|EG000|Reported Event|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by~injection ~6 weeks apart"
10953657|NCT00822237|EG001|Reported Event|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by~injection ~6 weeks apart"
10953658|NCT00822328|BG000|Baseline|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
10953659|NCT00822328|BG001|Baseline|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
10953660|NCT00822328|BG002|Baseline|Total|Total of all reporting groups
10953661|NCT00822328|FG000|Participant Flow|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
10953662|NCT00822328|FG001|Participant Flow|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
10953663|NCT00822328|OG000|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
10953664|NCT00822328|OG001|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
10953665|NCT00822328|EG000|Reported Event|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
10953666|NCT00822328|EG001|Reported Event|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
10953667|NCT00822354|BG000|Baseline|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
10953668|NCT00822354|BG001|Baseline|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
10953669|NCT00822354|BG002|Baseline|Total|Total of all reporting groups
10953670|NCT00822354|FG000|Participant Flow|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
10953671|NCT00822354|FG001|Participant Flow|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
10953672|NCT00822354|OG000|Outcome|Pre-treatment|
10953673|NCT00822354|OG001|Outcome|Week 4 of Treatment|
10953674|NCT00822354|OG002|Outcome|Pre-placebo|
10953675|NCT00822354|OG003|Outcome|Week 4 of Placebo|
10953676|NCT00822354|EG000|Reported Event|Tadalafil|Subjects received tadalafil 20 mg every other day for four weeks.
10953677|NCT00822354|EG001|Reported Event|Placebo|Subjects received placebo every other day for four weeks
10953678|NCT00822510|BG000|Baseline|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
10953679|NCT00822510|BG001|Baseline|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
10953680|NCT00822510|BG002|Baseline|Total|Total of all reporting groups
10953681|NCT00822510|FG000|Participant Flow|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
10953682|NCT00822510|FG001|Participant Flow|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
10953683|NCT00822510|OG000|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
10953684|NCT00822510|OG001|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
10953685|NCT00822510|OG000|Outcome|Telephone Interpersonal Counseling|"Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes.~Telephone Interpersonal Counseling: Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy."
10963717|NCT00873860|EG002|Reported Event|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10953686|NCT00822510|OG001|Outcome|Telephone Delivered Education Only|"Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes.~Telephone delivered education only: Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation"
10953687|NCT00822510|EG000|Reported Event|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
10953688|NCT00822510|EG001|Reported Event|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
10953689|NCT00822523|BG000|Baseline|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953690|NCT00822523|BG001|Baseline|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
10953691|NCT00822523|BG002|Baseline|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
10953692|NCT00822523|BG003|Baseline|Total|Total of all reporting groups
10953693|NCT00822523|FG000|Participant Flow|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953694|NCT00822523|FG001|Participant Flow|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
10953695|NCT00822523|FG002|Participant Flow|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
10953696|NCT00822523|OG000|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953697|NCT00822523|OG001|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
10953698|NCT00822523|OG002|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
11341763|NCT03687827|FG001|Participant Flow|Sequence B: Insulin Glargine 100U/mL Then Insulin Degludec 100U/mL|Participants were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin degludec 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
10953699|NCT00822523|OG000|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953700|NCT00822523|OG001|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953701|NCT00822523|OG001|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953702|NCT00822523|OG001|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953703|NCT00822523|OG001|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953704|NCT00822523|OG001|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953705|NCT00822523|OG001|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953706|NCT00822523|OG000|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953707|NCT00822523|EG000|Reported Event|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
10953708|NCT00822523|EG001|Reported Event|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
10953709|NCT00822523|EG002|Reported Event|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
10953710|NCT00822588|BG000|Baseline|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
10953711|NCT00822588|BG001|Baseline|No Sangvia|No autologous blood transfusion.
10953712|NCT00822588|BG002|Baseline|Total|Total of all reporting groups
10953713|NCT00822588|FG000|Participant Flow|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
10953714|NCT00822588|FG001|Participant Flow|No Sangvia|No autologous blood transfusion.
10953715|NCT00822588|OG000|Outcome|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
10953716|NCT00822588|OG001|Outcome|No Sangvia|No autologous blood transfusion.
11178579|NCT02048878|FG000|Participant Flow|Insomnia Group|"Assessment of physiologic hyper-arousal across the two following domains:~Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.~Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis."
11178580|NCT02048878|FG001|Participant Flow|Matched Control Group|"Assessment of physiologic hyper-arousal across the two following domains:~Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.~Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis."
11178581|NCT02048878|OG000|Outcome|Insomnia Group|"Assessment of physiologic hyper-arousal across the two following domains:~Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.~Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis."
11178582|NCT02048878|OG001|Outcome|Matched Control Group|"Assessment of physiologic hyper-arousal across the two following domains:~Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.~Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis."
11178583|NCT02048878|EG000|Reported Event|Insomnia Group|"Assessment of physiologic hyper-arousal across the two following domains:~Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.~Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis."
11192318|NCT02138227|OG000|Outcome|Novice Pre-Intervention Aggregate Relational Communication|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of novice requesters pre-intervention. Novice participants are defined has having less than 12 months of experience.
10953717|NCT00822588|EG000|Reported Event|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
10953718|NCT00822588|EG001|Reported Event|No Sangvia|No autologous blood transfusion.
10953719|NCT00822692|BG000|Baseline|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
10953720|NCT00822692|BG001|Baseline|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
10953721|NCT00822692|BG002|Baseline|Total|Total of all reporting groups
10953722|NCT00822692|FG000|Participant Flow|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
10953723|NCT00822692|FG001|Participant Flow|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
10953724|NCT00822692|OG000|Outcome|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
10953725|NCT00822692|OG001|Outcome|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
10953726|NCT00822692|EG000|Reported Event|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|bactrim DS (800/160) two tablets PO BID x 7 days
10953727|NCT00822692|EG001|Reported Event|Matched Placebo 2 Pills PO BID x 7 Days|matched placebo 2 pills PO BID x 7 days
10953728|NCT00822757|BG000|Baseline|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
10953729|NCT00822757|BG001|Baseline|Placebo|Saline placebo single dose at baseline.
10953730|NCT00822757|BG002|Baseline|Total|Total of all reporting groups
10953731|NCT00822757|FG000|Participant Flow|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
10953732|NCT00822757|FG001|Participant Flow|Placebo|Saline placebo single dose at baseline.
10953733|NCT00822757|OG000|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
10953734|NCT00822757|OG001|Outcome|Placebo|Saline placebo single dose at baseline.
10953735|NCT00822757|EG000|Reported Event|V710 (60 mcg) Lyophilized|V710 (60 mcg)single dose at baseline.
10953736|NCT00822757|EG001|Reported Event|Placebo|Saline placebo single dose at baseline.
10953737|NCT00822770|BG000|Baseline|Phase I Plerixafor + G-CSF|Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)
10953738|NCT00822770|BG001|Baseline|Phase II Plerixafor 240 mcg/kg + G-CSF|Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
10953739|NCT00822770|BG002|Baseline|Total|Total of all reporting groups
10953740|NCT00822770|FG000|Participant Flow|Phase I Plerixafor + G-CSF|Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)
10953741|NCT00822770|FG001|Participant Flow|Phase II Plerixafor 240 mcg/kg + G-CSF|Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
10953742|NCT00822770|OG000|Outcome|Phase I Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses."
10953743|NCT00822770|OG000|Outcome|Overall Study: Plerixafor + G-CSF|Plerixafor escalating doses 0, 80, 160, 240 mcg/kg or MTD 240 mcg/kg given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)
10953744|NCT00822770|EG000|Reported Event|Phase I Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant:~Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)"
10953745|NCT00822770|EG001|Reported Event|Phase II Plerixafor 240 mcg/kg + G-CSF|Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
10953746|NCT00822900|BG000|Baseline|Progesterone|
10953747|NCT00822900|BG001|Baseline|Placebo|
10953748|NCT00822900|BG002|Baseline|Total|Total of all reporting groups
10953749|NCT00822900|FG000|Participant Flow|Progesterone|
10953750|NCT00822900|FG001|Participant Flow|Placebo|
10953751|NCT00822900|OG000|Outcome|Progesterone|
10953752|NCT00822900|OG001|Outcome|Placebo|
10953753|NCT00822900|EG000|Reported Event|Progesterone|
10953754|NCT00822900|EG001|Reported Event|Placebo|
10953755|NCT00822926|BG000|Baseline|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
10953756|NCT00822926|BG001|Baseline|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
10953757|NCT00822926|BG002|Baseline|Total|Total of all reporting groups
10953758|NCT00822926|FG000|Participant Flow|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
10953759|NCT00822926|FG001|Participant Flow|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
10953760|NCT00822926|OG000|Outcome|Placebo|Saline- Subcutaneous injection of saline into scar tissue
10953761|NCT00822926|OG001|Outcome|Botox|Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
10953762|NCT00822926|OG000|Outcome|Baseline|
10953763|NCT00822926|OG001|Outcome|Placebo|Saline- Subcutaneous injection of saline into scar tissue
10953764|NCT00822926|OG002|Outcome|Botox|Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
10953765|NCT00822926|EG000|Reported Event|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
10953766|NCT00822926|EG001|Reported Event|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
10953767|NCT00823043|BG000|Baseline|Total Subject Population|All subjects responding to survey
10953768|NCT00823043|FG000|Participant Flow|Timolol Hemihydrate|Timolol hemihydrate 0.5% ophthalmic solution.
10953769|NCT00823043|FG001|Participant Flow|Timolol Maleate in Sorbate|Timolol maleate in sorbate 0.5% ophthalmic solution
10953770|NCT00823043|OG000|Outcome|Timolol Hemihydrate|
10953771|NCT00823043|OG001|Outcome|Timolol Maleate in Sorbate|
10953772|NCT00823043|EG000|Reported Event|Total Subjects Surveyed|
10953773|NCT00823069|BG000|Baseline|Perlane and Perlane-L|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
10953774|NCT00823069|FG000|Participant Flow|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
10953775|NCT00823069|OG000|Outcome|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
10953776|NCT00823069|OG000|Outcome|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
10953777|NCT00823069|OG001|Outcome|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
10953778|NCT00823069|EG000|Reported Event|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
10953779|NCT00823069|EG001|Reported Event|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
10953780|NCT00823082|BG000|Baseline|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
10953781|NCT00823082|BG001|Baseline|Control Group|No preoperative ATIII supplementation administered
10953782|NCT00823082|BG002|Baseline|Total|Total of all reporting groups
10953783|NCT00823082|FG000|Participant Flow|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
10953784|NCT00823082|FG001|Participant Flow|Control Group|No preoperative ATIII supplementation administered
10953785|NCT00823082|OG000|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
11178584|NCT02048878|EG001|Reported Event|Matched Control Group|"Assessment of physiologic hyper-arousal across the two following domains:~Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness.~Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis."
11178585|NCT02048891|BG000|Baseline|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
10953786|NCT00823082|OG001|Outcome|Control Group|No preoperative ATIII supplementation administered
10953787|NCT00823082|EG000|Reported Event|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
10953788|NCT00823082|EG001|Reported Event|Control Group|No preoperative ATII supplementation administered
10953789|NCT00823134|BG000|Baseline|PSG/ApneaLink|Sleep Evaluation under Polysomnography and with ApneaLink
10953790|NCT00823134|FG000|Participant Flow|PSG/ApneaLink|Sleep Evaluation under Polysomnography and with ApneaLink
10953791|NCT00823134|OG000|Outcome|PSG/ApneaLink|Sleep Evaluation under Polysomnography and with ApneaLink
10953792|NCT00823134|OG000|Outcome|AL + Polysomnography|"Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).~ApneaLink Plus: Device used to evaluate for the presence of obstructive, central or mixed apneas"
10953793|NCT00823134|EG000|Reported Event|PSG/ApneaLink|Sleep Evaluation under Polysomnography and with ApneaLink
10953794|NCT00823199|BG000|Baseline|Group 1|All participants
10953795|NCT00823199|FG000|Participant Flow|Allopurinal Treatment|
10953796|NCT00823199|OG000|Outcome|Allopurinal Treatment|
10953797|NCT00823199|OG000|Outcome|Allopurinal Treatment|all participants
10953798|NCT00823199|EG000|Reported Event|Group 1|All participants
10953799|NCT00823212|BG000|Baseline|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
10953800|NCT00823212|BG001|Baseline|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
11178586|NCT02048891|BG001|Baseline|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
11178587|NCT02048891|BG002|Baseline|Total|Total of all reporting groups
10953801|NCT00823212|BG002|Baseline|Total|Total of all reporting groups
10953802|NCT00823212|FG000|Participant Flow|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
10953803|NCT00823212|FG001|Participant Flow|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
10953804|NCT00823212|OG000|Outcome|PROMUS|PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
10953805|NCT00823212|OG001|Outcome|PROMUS Element|PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
10953806|NCT00823212|OG000|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
10953807|NCT00823212|OG001|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
11178588|NCT02048891|FG000|Participant Flow|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
11178589|NCT02048891|FG001|Participant Flow|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
10953808|NCT00823212|EG000|Reported Event|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
10953809|NCT00823212|EG001|Reported Event|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
10953810|NCT00823264|BG000|Baseline|Control|Will not receive activated charcoal. Serum levels will be followed.
10953811|NCT00823264|BG001|Baseline|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are < 25 ug/cc.
10953812|NCT00823264|BG002|Baseline|Total|Total of all reporting groups
10953813|NCT00823264|FG000|Participant Flow|Control|Will not receive activated charcoal. Serum levels will be followed.
10953814|NCT00823264|FG001|Participant Flow|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is < 25 ug/cc.
10953815|NCT00823264|OG000|Outcome|Control|Will not receive activated charcoal. Serum levels will be followed.
10953816|NCT00823264|OG001|Outcome|Multiple Doses of Activated Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
10953817|NCT00823264|EG000|Reported Event|Multiple Doses of Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
10953818|NCT00823264|EG001|Reported Event|Control|Will not receive activated charcoal. Serum levels will be followed.
10963718|NCT00873860|EG003|Reported Event|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
10963719|NCT00873873|BG000|Baseline|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
10963720|NCT00873873|BG001|Baseline|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
10963721|NCT00873873|BG002|Baseline|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
10963722|NCT00873873|BG003|Baseline|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
10963723|NCT00873873|BG004|Baseline|Total|Total of all reporting groups
10963724|NCT00873873|FG000|Participant Flow|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
10963725|NCT00873873|FG001|Participant Flow|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
10963726|NCT00873873|FG002|Participant Flow|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
10963727|NCT00873873|FG003|Participant Flow|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
10963728|NCT00873873|OG000|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
11178590|NCT02048891|OG000|Outcome|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
11178591|NCT02048891|OG001|Outcome|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
11178592|NCT02048891|EG000|Reported Event|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
11178593|NCT02048891|EG001|Reported Event|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
11178594|NCT02049151|BG000|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
10953819|NCT00823303|BG000|Baseline|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
10953820|NCT00823303|BG001|Baseline|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
10953821|NCT00823303|BG002|Baseline|Total|Total of all reporting groups
10953822|NCT00823303|FG000|Participant Flow|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
10953823|NCT00823303|FG001|Participant Flow|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
10953824|NCT00823303|OG000|Outcome|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
10953825|NCT00823303|OG001|Outcome|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
10953826|NCT00823303|EG000|Reported Event|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
11178595|NCT02049151|BG001|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
10953827|NCT00823303|EG001|Reported Event|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
10953828|NCT00823459|BG000|Baseline|Daily Intervention With RAD001|RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.
10953829|NCT00823459|FG000|Participant Flow|Daily Intervention With RAD001|Single arm study: RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.
10953830|NCT00823459|OG000|Outcome|Daily Intervention With RAD001|"RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.~RAD001: RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food."
11178596|NCT02049151|BG002|Baseline|Total Title|
10953831|NCT00823459|OG000|Outcome|Daily Intervention With RAD001|RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.
10953832|NCT00823459|EG000|Reported Event|Daily Intervention With RAD001|RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.
10953833|NCT00823472|BG000|Baseline|Start rFSH Cycle Day 2|Start 150IU rFSH s.c. cycle day 2
10953834|NCT00823472|BG001|Baseline|Start rFSH on Cycle Day 5|Start 150IU rFSH s.c. cycle day 5
10953835|NCT00823472|BG002|Baseline|Total|Total of all reporting groups
10953836|NCT00823472|FG000|Participant Flow|Start rFSH Cycle Day 2|Start 150 IU rFSH subcutaneously on cycle day 2
11178597|NCT02049151|FG000|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
10953837|NCT00823472|FG001|Participant Flow|Start rFSH on Cycle Day 5|Start 150 IU rFSH subcutaneously on cycle day 5
10953838|NCT00823472|OG000|Outcome|Start rFSH Cycle Day 2|Start 150IU rFSH s.c. cycle day 2
10953839|NCT00823472|OG001|Outcome|Start rFSH on Cycle Day 5|Start 150IU rFSH s.c. cycle day 5
10953840|NCT00823472|EG000|Reported Event|Start rFSH Cycle Day 2|Start 150IU rFSH s.c. cycle day 2
10953841|NCT00823472|EG001|Reported Event|Start rFSH on Cycle Day 5|Start 150IU rFSH s.c. cycle day 2=5
10953842|NCT00823615|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects
10953843|NCT00823615|FG000|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis.
10953844|NCT00823615|FG001|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis.
10953845|NCT00823615|OG000|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
10953846|NCT00823615|OG001|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
10953847|NCT00823615|EG000|Reported Event|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
10953848|NCT00823615|EG001|Reported Event|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
10963729|NCT00873873|OG001|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
10953849|NCT00823719|BG000|Baseline|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
10953850|NCT00823719|BG001|Baseline|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
10953851|NCT00823719|BG002|Baseline|Total|Total of all reporting groups
10953852|NCT00823719|FG000|Participant Flow|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
10953853|NCT00823719|FG001|Participant Flow|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
10953854|NCT00823719|OG000|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
10953855|NCT00823719|OG001|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
10953856|NCT00823719|OG002|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
10953857|NCT00823719|EG000|Reported Event|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
10953858|NCT00823719|EG001|Reported Event|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
10963730|NCT00873873|OG002|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
10963731|NCT00873873|OG003|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
10963732|NCT00873873|EG000|Reported Event|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
10953859|NCT00823719|EG002|Reported Event|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
11234347|NCT02434081|EG000|Reported Event|Concurrent CRT-Nivo|"4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.~Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation."
11234348|NCT02434328|BG000|Baseline|Brolucizumab 6 mg|Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
11234349|NCT02434328|BG001|Baseline|Aflibercept 2 mg|Single IVT injection of aflibercept at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
11234350|NCT02434328|BG002|Baseline|Total|Total of all reporting groups
10953860|NCT00823797|BG000|Baseline|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
10953861|NCT00823797|BG001|Baseline|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
10953862|NCT00823797|BG002|Baseline|Total|Total of all reporting groups
10953863|NCT00823797|FG000|Participant Flow|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
10953864|NCT00823797|FG001|Participant Flow|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
11234351|NCT02434328|FG000|Participant Flow|Brolucizumab 6 mg|Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
11234352|NCT02434328|FG001|Participant Flow|Aflibercept 2 mg|Single IVT injection of aflibercept at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
11234353|NCT02434328|OG000|Outcome|Brolucizumab 6 mg|Single IVT injection of brolucizumab at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
11234354|NCT02434328|OG001|Outcome|Aflibercept 2 mg|Single IVT injection of aflibercept at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
11234355|NCT02434328|OG000|Outcome|Brolucizumab 6 mg|Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
11234356|NCT02434328|EG000|Reported Event|Brolucizumab 6mg|All subjects exposed to brolucizumab ophthalmic solution administered as a 6 mg/50 microliter (μL) dose
11234357|NCT02434328|EG001|Reported Event|Aflibercept 2mg|All subjects exposed to aflibercept ophthalmic solution administered as a 2 mg/50 μL dose
10953865|NCT00823797|OG000|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
10953866|NCT00823797|OG001|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
10953867|NCT00823797|EG000|Reported Event|Treatment (Bendamustine Hydrochloride)|"Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Quality-of-Life Assessment: Ancillary studies"
10953868|NCT00823823|BG000|Baseline|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
10953869|NCT00823823|BG001|Baseline|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
10953870|NCT00823823|BG002|Baseline|Total|Total of all reporting groups
10953871|NCT00823823|FG000|Participant Flow|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
10953872|NCT00823823|FG001|Participant Flow|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
10953873|NCT00823823|OG000|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
10953874|NCT00823823|OG001|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
10953875|NCT00823823|EG000|Reported Event|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
10953876|NCT00823823|EG001|Reported Event|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
10953877|NCT00823836|BG000|Baseline|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953878|NCT00823836|BG001|Baseline|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953879|NCT00823836|BG002|Baseline|Total|Total of all reporting groups
10953880|NCT00823836|FG000|Participant Flow|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953881|NCT00823836|FG001|Participant Flow|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953882|NCT00823836|OG000|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953883|NCT00823836|OG001|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953884|NCT00823836|OG000|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10963733|NCT00873873|EG001|Reported Event|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
10963734|NCT00873873|EG002|Reported Event|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
11234358|NCT02434471|BG000|Baseline|All Subjects|All study subjects
11234359|NCT02434471|FG000|Participant Flow|Conventional Breath-held LAVA Then Respiratory Triggered Exams|All study subjects underwent an MRI exam including conventional breath-held LAVA imaging pre- and post-contrast, as well as respiratory-triggered DISCO imaging pre- and post-contrast
10953885|NCT00823836|OG001|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953886|NCT00823836|OG000|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953887|NCT00823836|EG000|Reported Event|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953888|NCT00823836|EG001|Reported Event|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
10953889|NCT00823901|BG000|Baseline|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
10953890|NCT00823901|BG001|Baseline|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
10953891|NCT00823901|BG002|Baseline|Total|Total of all reporting groups
10953892|NCT00823901|FG000|Participant Flow|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
10953893|NCT00823901|FG001|Participant Flow|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
10953894|NCT00823901|OG000|Outcome|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
10953895|NCT00823901|OG001|Outcome|Placebo|Participants applied placebo gel without active ingredient on entire face (forehead, nose, cheek, chin)once daily at night for 12 weeks
10953896|NCT00823901|EG000|Reported Event|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
10953897|NCT00823901|EG001|Reported Event|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
10953898|NCT00823966|BG000|Baseline|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
10953899|NCT00823966|FG000|Participant Flow|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
10953900|NCT00823966|OG000|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
10963735|NCT00873873|EG003|Reported Event|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
11178598|NCT02049151|FG001|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
11192319|NCT02138227|OG001|Outcome|Novice Post-Intervention Relational Communication (Autonomous)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of novice requesters from the autonomous arm. Novice participants are defined has having less than 12 months of experience.
10953901|NCT00823966|EG000|Reported Event|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
10953902|NCT00823979|BG000|Baseline|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953903|NCT00823979|BG001|Baseline|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953904|NCT00823979|BG002|Baseline|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953905|NCT00823979|BG003|Baseline|Total|Total of all reporting groups
10953906|NCT00823979|FG000|Participant Flow|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953907|NCT00823979|FG001|Participant Flow|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953908|NCT00823979|FG002|Participant Flow|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953909|NCT00823979|OG000|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953910|NCT00823979|OG001|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953911|NCT00823979|OG002|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953912|NCT00823979|EG000|Reported Event|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953913|NCT00823979|EG001|Reported Event|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953914|NCT00823979|EG002|Reported Event|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
10953915|NCT00824005|BG000|Baseline|Placebo Injections|Participants will receive placebo injections.
10953916|NCT00824005|BG001|Baseline|Active Stem Cell Injections|Participants will receive active stem cell injections.
10953917|NCT00824005|BG002|Baseline|Total|Total of all reporting groups
10953918|NCT00824005|FG000|Participant Flow|Placebo Injections|Participants will receive placebo injections.
10953919|NCT00824005|FG001|Participant Flow|Active Stem Cell Injections|Participants will receive active stem cell injections.
10953920|NCT00824005|OG000|Outcome|Placebo Injections|Participants received placebo injections.
10953921|NCT00824005|OG001|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
10953922|NCT00824005|EG000|Reported Event|Placebo Injections|Participants received placebo injections.
10953923|NCT00824005|EG001|Reported Event|Active Stem Cell Injections|Participants received active stem cell injections.
10953924|NCT00824044|BG000|Baseline|Cognitive Behavioral Therapy (CBT)|The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
10953925|NCT00824044|BG001|Baseline|Escitalopram|The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
10953926|NCT00824044|BG002|Baseline|Total|Total of all reporting groups
10953927|NCT00824044|FG000|Participant Flow|Cognitive Behavioral Therapy (CBT)|The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
10953928|NCT00824044|FG001|Participant Flow|Escitalopram|The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
10953929|NCT00824044|OG000|Outcome|Cognitive Behavioral Therapy (CBT)|Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
10953930|NCT00824044|OG001|Outcome|Escitalopram|Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
10953931|NCT00824044|OG000|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
10953932|NCT00824044|OG001|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
10953933|NCT00824044|OG002|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
10953934|NCT00824044|OG003|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
10953935|NCT00824044|EG000|Reported Event|Cognitive Behavioral Therapy (CBT)|The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
10953936|NCT00824044|EG001|Reported Event|Escitalopram|The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
10953937|NCT00824070|BG000|Baseline|Besifloxacin|Besifloxacin ophthalmic suspension
10953938|NCT00824070|BG001|Baseline|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
10953939|NCT00824070|BG002|Baseline|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
10953940|NCT00824070|BG003|Baseline|Total|Total of all reporting groups
11178599|NCT02049151|OG000|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
10953941|NCT00824070|FG000|Participant Flow|Besifloxacin|Besifloxacin ophthalmic suspension
10953942|NCT00824070|FG001|Participant Flow|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
10953943|NCT00824070|FG002|Participant Flow|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
10953944|NCT00824070|OG000|Outcome|Besifloxacin|Besifloxacin ophthalmic suspension
11234360|NCT02434471|OG000|Outcome|Breath Hold Liver Acquisition With Volume Acquisition (LAVA)|Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.
10953945|NCT00824070|OG001|Outcome|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
10953946|NCT00824070|OG002|Outcome|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
10953947|NCT00824070|EG000|Reported Event|Besifloxacin|Besifloxacin ophthalmic suspension
10953948|NCT00824070|EG001|Reported Event|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
10953949|NCT00824070|EG002|Reported Event|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
10953950|NCT00824161|BG000|Baseline|TAS-109|TAS-109 2.0 mg/m^2/day
10953951|NCT00824161|FG000|Participant Flow|TAS-109|TAS-109 2.0 mg/m^2/day
10953952|NCT00824161|OG000|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day Independent Assessment
10953953|NCT00824161|OG000|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
10953954|NCT00824161|EG000|Reported Event|TAS-109|TAS-109 2.0 mg/m^2/day
10953955|NCT00824265|BG000|Baseline|Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953956|NCT00824265|BG001|Baseline|Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953957|NCT00824265|BG002|Baseline|Total|Total of all reporting groups
10953958|NCT00824265|FG000|Participant Flow|Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953959|NCT00824265|FG001|Participant Flow|Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953960|NCT00824265|OG000|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953961|NCT00824265|OG001|Outcome|Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953962|NCT00824265|OG000|Outcome|Ofatumumab+Fludarabine+Cyclophosphamide_anti-CLL Therapies|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
11178600|NCT02049151|OG001|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
11178601|NCT02049151|EG000|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented
11178602|NCT02049151|EG001|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
11178603|NCT02049307|BG000|Baseline|Treatment (Losartan)|Participants receive Losartan 100mg daily
10953963|NCT00824265|OG001|Outcome|Fludarabine+Cyclophosphamide_anti-CLL Therapies|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953964|NCT00824265|OG002|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953965|NCT00824265|OG003|Outcome|Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953966|NCT00824265|EG000|Reported Event|Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953967|NCT00824265|EG001|Reported Event|Fludarabine + Cyclophosphamide_ ITT Subjects|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
10953968|NCT00824291|BG000|Baseline|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
10953969|NCT00824291|BG001|Baseline|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
10953970|NCT00824291|BG002|Baseline|Total|Total of all reporting groups
10953971|NCT00824291|FG000|Participant Flow|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
10953972|NCT00824291|FG001|Participant Flow|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
10953973|NCT00824291|OG000|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
10953974|NCT00824291|OG001|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
10953975|NCT00824291|EG000|Reported Event|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
11178604|NCT02049307|BG001|Baseline|Placebo|Participants receive a matching placebo daily
11178605|NCT02049307|BG002|Baseline|Total|Total of all reporting groups
11178606|NCT02049307|FG000|Participant Flow|Treatment (Losartan)|Participants receive Losartan 100mg daily
11178607|NCT02049307|FG001|Participant Flow|Placebo|Participants receive a matching placebo daily
11178608|NCT02049307|OG000|Outcome|Treatment|"Losartan 100mg daily~Losartan 100mg daily"
11178609|NCT02049307|OG001|Outcome|Placebo|"Matching placebo~Matching placebo"
11178610|NCT02049307|OG000|Outcome|Treatment (Losartan)|Participants receive Losartan 100mg daily
11178611|NCT02049307|OG001|Outcome|Placebo|Participants receive a matching placebo daily
11178612|NCT02049307|EG000|Reported Event|Treatment (Losartan)|Losartan 100mg provided daily
10953976|NCT00824291|EG001|Reported Event|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
10953977|NCT00824369|BG000|Baseline|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
10953978|NCT00824369|BG001|Baseline|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
10953979|NCT00824369|BG002|Baseline|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
10953980|NCT00824369|BG003|Baseline|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
10953981|NCT00824369|BG004|Baseline|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
10953982|NCT00824369|BG005|Baseline|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
11178613|NCT02049307|EG001|Reported Event|Placebo|Matching placebo provided daily
11178614|NCT02049385|BG000|Baseline|All Participants|Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was, adjusted depending on side effects and response.
11178615|NCT02049385|FG000|Participant Flow|Diazoxide, Then Placebo|Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
11178616|NCT02049385|FG001|Participant Flow|Placebo, Then Diazoxide|Subjects received a matched placebo for three weeks.
11178617|NCT02049385|OG000|Outcome|Diazoxide|Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
11178618|NCT02049385|OG001|Outcome|Placebo|Subjects received a matched placebo for three weeks.
10953983|NCT00824369|BG006|Baseline|Total|Total of all reporting groups
10953984|NCT00824369|FG000|Participant Flow|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
10953985|NCT00824369|FG001|Participant Flow|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
10953986|NCT00824369|FG002|Participant Flow|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
10953987|NCT00824369|FG003|Participant Flow|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
10953988|NCT00824369|FG004|Participant Flow|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
10953989|NCT00824369|FG005|Participant Flow|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
10953990|NCT00824369|OG000|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
10953991|NCT00824369|OG001|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
10953992|NCT00824369|OG002|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
10953993|NCT00824369|OG003|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
10953994|NCT00824369|OG004|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
10953995|NCT00824369|OG005|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
10953996|NCT00824369|EG000|Reported Event|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
10953997|NCT00824369|EG001|Reported Event|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
10953998|NCT00824369|EG002|Reported Event|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
10953999|NCT00824369|EG003|Reported Event|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
10954000|NCT00824369|EG004|Reported Event|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
10954001|NCT00824369|EG005|Reported Event|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
10954002|NCT00824382|BG000|Baseline|Placebo|Placebo
10954003|NCT00824382|BG001|Baseline|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
10954004|NCT00824382|BG002|Baseline|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
10954005|NCT00824382|BG003|Baseline|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
11178619|NCT02049385|EG000|Reported Event|Diazoxide|Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
11178620|NCT02049385|EG001|Reported Event|Placebo|Subjects received a matched placebo for three weeks.
11178621|NCT02049437|BG000|Baseline|Arm A: TCZ, Then Placebo|ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 and 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.
11178622|NCT02049437|BG001|Baseline|Arm B: Placebo, Then TCZ|ARM B: Placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 minutes once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28.
11178623|NCT02049437|BG002|Baseline|Total|Total of all reporting groups
10954006|NCT00824382|BG004|Baseline|Total|Total of all reporting groups
10954007|NCT00824382|FG000|Participant Flow|Placebo|Placebo
10954008|NCT00824382|FG001|Participant Flow|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
10954009|NCT00824382|FG002|Participant Flow|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
10954010|NCT00824382|FG003|Participant Flow|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
10954011|NCT00824382|OG000|Outcome|Placebo|Placebo
10954012|NCT00824382|OG001|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
10954013|NCT00824382|OG002|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
10954014|NCT00824382|OG003|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
10954015|NCT00824382|OG000|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
10954016|NCT00824382|OG001|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
10954017|NCT00824382|EG000|Reported Event|Placebo|Placebo
10954018|NCT00824382|EG001|Reported Event|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
11341764|NCT03687827|OG000|Outcome|Insulin Degludec 100U/mL|Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
10954019|NCT00824382|EG002|Reported Event|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
10954020|NCT00824382|EG003|Reported Event|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
10954021|NCT00824408|BG000|Baseline|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
10954022|NCT00824408|BG001|Baseline|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954023|NCT00824408|BG002|Baseline|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
10954024|NCT00824408|BG003|Baseline|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
10954025|NCT00824408|BG004|Baseline|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954026|NCT00824408|BG005|Baseline|Total|Total of all reporting groups
10954027|NCT00824408|FG000|Participant Flow|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
10954028|NCT00824408|FG001|Participant Flow|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954029|NCT00824408|FG002|Participant Flow|Randomized Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle
10954030|NCT00824408|FG003|Participant Flow|Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously on day 1 of each 21 day cycle
10954031|NCT00824408|FG004|Participant Flow|Randomized Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954032|NCT00824408|OG000|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
10954033|NCT00824408|OG001|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
10954034|NCT00824408|OG002|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954035|NCT00824408|OG000|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
10954036|NCT00824408|OG001|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954037|NCT00824408|OG002|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
10954038|NCT00824408|OG003|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
10954039|NCT00824408|OG004|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954040|NCT00824408|OG000|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
10954041|NCT00824408|OG001|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954042|NCT00824408|OG002|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
10954043|NCT00824408|EG000|Reported Event|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
10954044|NCT00824408|EG001|Reported Event|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954045|NCT00824408|EG002|Reported Event|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
10954046|NCT00824408|EG003|Reported Event|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
10954047|NCT00824408|EG004|Reported Event|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
10954048|NCT00824421|BG000|Baseline|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954049|NCT00824421|BG001|Baseline|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954050|NCT00824421|BG002|Baseline|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954051|NCT00824421|BG003|Baseline|Total|Total of all reporting groups
10954052|NCT00824421|FG000|Participant Flow|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954053|NCT00824421|FG001|Participant Flow|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954054|NCT00824421|FG002|Participant Flow|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954055|NCT00824421|OG000|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954056|NCT00824421|OG001|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954057|NCT00824421|OG002|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954058|NCT00824421|OG000|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
10954059|NCT00824421|OG001|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
10954060|NCT00824421|EG000|Reported Event|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954061|NCT00824421|EG001|Reported Event|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
10954062|NCT00824421|EG002|Reported Event|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
11234361|NCT02434471|OG001|Outcome|Respiratory-triggered T1w DISCO LAVA|"The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.~Respiratory-triggered T1w DISCO LAVA: The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.~Respiratory-triggered T1w DISCO LAVA precontrast~Respiratory-triggered T1w DISCO LAVA in the portal venous phase~Respiratory-triggered T1w DISCO LAVA in the equilibrium phase"
11234362|NCT02434471|EG000|Reported Event|All Subjects|All subjects who completed the study
11234363|NCT02434497|BG000|Baseline|Overall|All patients
11234364|NCT02434497|FG000|Participant Flow|Overall|All patients
11234365|NCT02434497|OG000|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
11234366|NCT02434497|OG000|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
11234367|NCT02434497|OG001|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
11234368|NCT02434497|EG000|Reported Event|Overall|All patients
11234369|NCT02434523|BG000|Baseline|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
11234370|NCT02434523|BG001|Baseline|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
11234371|NCT02434523|BG002|Baseline|Total|Total of all reporting groups
11234372|NCT02434523|FG000|Participant Flow|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
11234373|NCT02434523|FG001|Participant Flow|Placebo|Subjects in this arm will receive pills composed only of Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
10954063|NCT00824434|BG000|Baseline|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
10954064|NCT00824434|FG000|Participant Flow|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
10954065|NCT00824434|OG000|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
11234374|NCT02434523|OG000|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
10954066|NCT00824434|EG000|Reported Event|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
10954067|NCT00824460|BG000|Baseline|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
10954068|NCT00824460|BG001|Baseline|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
10954069|NCT00824460|BG002|Baseline|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
10954070|NCT00824460|BG003|Baseline|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
10954071|NCT00824460|BG004|Baseline|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
10954072|NCT00824460|BG005|Baseline|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
10954073|NCT00824460|BG006|Baseline|Total|Total of all reporting groups
10954074|NCT00824460|FG000|Participant Flow|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
10954075|NCT00824460|FG001|Participant Flow|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
10954076|NCT00824460|FG002|Participant Flow|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
10954077|NCT00824460|FG003|Participant Flow|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
10954078|NCT00824460|FG004|Participant Flow|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
10954079|NCT00824460|FG005|Participant Flow|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
10954080|NCT00824460|OG000|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
11234375|NCT02434523|OG001|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
10954081|NCT00824460|OG001|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
10954082|NCT00824460|OG002|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
10954083|NCT00824460|OG003|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
10954084|NCT00824460|OG004|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
10954085|NCT00824460|OG005|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
10954086|NCT00824460|OG004|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
10954087|NCT00824460|OG000|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25g PA21 (1 tablet)
10954088|NCT00824460|OG001|Outcome|5.0g PA21 (1,000 mg Iron)|Daily dose of 5.0g PA21 (4 tablets)
10954089|NCT00824460|OG002|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5g PA21 (6 tablets)
10954090|NCT00824460|OG003|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
10954091|NCT00824460|OG004|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5g PA21 (10 tablets)
10954092|NCT00824460|OG005|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8g sevelamer hydrochloride (6 tablets)
10954093|NCT00824460|OG005|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
10954094|NCT00824460|EG000|Reported Event|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
10954095|NCT00824460|EG001|Reported Event|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
10954096|NCT00824460|EG002|Reported Event|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
10954097|NCT00824460|EG003|Reported Event|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
10954098|NCT00824460|EG004|Reported Event|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
10954099|NCT00824460|EG005|Reported Event|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
10954100|NCT00824473|BG000|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
10954101|NCT00824473|BG001|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
10954102|NCT00824473|BG002|Baseline|Total|Total of all reporting groups
10954103|NCT00824473|FG000|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
10954104|NCT00824473|FG001|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
10954105|NCT00824473|OG000|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
10954106|NCT00824473|OG001|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
10954107|NCT00824473|EG000|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
10954108|NCT00824473|EG001|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
10954109|NCT00824512|BG000|Baseline|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
10954110|NCT00824512|BG001|Baseline|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.~Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
10954111|NCT00824512|BG002|Baseline|Total|Total of all reporting groups
10954112|NCT00824512|FG000|Participant Flow|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
10954113|NCT00824512|FG001|Participant Flow|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
10954114|NCT00824512|OG000|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
10954115|NCT00824512|OG001|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
10954116|NCT00824512|EG000|Reported Event|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
10954117|NCT00824512|EG001|Reported Event|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.~Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
10954118|NCT00824538|BG000|Baseline|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
10954119|NCT00824538|FG000|Participant Flow|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
10954120|NCT00824538|OG000|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
10954121|NCT00824538|OG000|Outcome|Sunitinib|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
10954122|NCT00824538|EG000|Reported Event|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
10954123|NCT00824564|BG000|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
11178624|NCT02049437|FG000|Participant Flow|Arm A: TCZ, Then Placebo|ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 and 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.
10954124|NCT00824564|BG001|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
11178625|NCT02049437|FG001|Participant Flow|Arm B: Placebo, Then TCZ|ARM B: Placebo by IV infusion at study entry, followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 min once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 min at weeks 24 and 28.
11178626|NCT02049437|OG000|Outcome|Tocilizumab|"Patients from Arm A that obtained TCZ, 4 mg/kg by IV infusion over 60 min (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/kg by IV infusion over 60 min (not to exceed 800 mg) at weeks 4, and 8.~Patients from Arm B that obtained TCZ, 4 mg/kg by IV infusion over 60 min (not to exceed 400 mg) once at week 20, followed by TCZ, 8 mg/kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28 after the first (placebo) interventional period and washout period"
11178627|NCT02049437|OG001|Outcome|Placebo|"Patients from Arm A that, after washout period 1, obtained placebo by IV infusion at weeks 20, 24 and 28.~Patients from Arm B that obtained placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8."
11178628|NCT02049437|EG000|Reported Event|Tocilizumab|"Patients from Arm A that obtained TCZ, 4 mg/kg by IV infusion over 60 min (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/kg by IV infusion over 60 min (not to exceed 800 mg) at weeks 4, and 8.~Patients from Arm B that obtained TCZ, 4 mg/kg by IV infusion over 60 min (not to exceed 400 mg) once at week 20, followed by TCZ, 8 mg/kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28 after the first (placebo) interventional period and washout period"
11178629|NCT02049437|EG001|Reported Event|Placebo|"Patients from Arm A that, after washout period 1, obtained placebo by IV infusion at weeks 20, 24 and 28.~Patients from Arm B that obtained placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8."
11178630|NCT02049450|BG000|Baseline|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
11178631|NCT02049450|FG000|Participant Flow|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
10954125|NCT00824564|BG002|Baseline|Total|Total of all reporting groups
10954126|NCT00824564|FG000|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
10954127|NCT00824564|FG001|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
11178632|NCT02049450|OG000|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
11178633|NCT02049450|OG000|Outcome|10 mg Bid|Patients who received INC422 10mg bid
11178634|NCT02049450|OG001|Outcome|15mg Bid|Patients who received INC422 15mg bid
11178635|NCT02049450|OG002|Outcome|20mg Bid|Patients who received INC422 20mg bid
11178636|NCT02049450|OG000|Outcome|5mg Bid|Patients who received INC422 5mg bid
11178637|NCT02049450|OG001|Outcome|10mg Bid|Patients who received INC422 10mg bid
11178638|NCT02049450|OG002|Outcome|15mg Bid|Patients who received INC422 15mg bid
11178639|NCT02049450|OG003|Outcome|20mg Bid|Patients who received INC422 20mg bid
11178640|NCT02049450|EG000|Reported Event|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
11178641|NCT02049476|BG000|Baseline|Dexamethasone Pellet|"This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.~Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.~Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol."
11234376|NCT02434523|OG000|Outcome|Amitriptyline|"Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)~Amitriptyline"
10954128|NCT00824564|OG000|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
10954129|NCT00824564|OG001|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
10954130|NCT00824564|EG000|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
10954131|NCT00824564|EG001|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
10954132|NCT00824616|BG000|Baseline|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
10954133|NCT00824616|BG001|Baseline|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
10954134|NCT00824616|BG002|Baseline|Total|Total of all reporting groups
10954135|NCT00824616|FG000|Participant Flow|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
10954136|NCT00824616|FG001|Participant Flow|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
10954137|NCT00824616|OG000|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
11178642|NCT02049476|FG000|Participant Flow|Dexamethasone Pellet|"This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.~Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.~Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol."
11192320|NCT02138227|OG002|Outcome|Novice Post-Intervention Relational Communication (Assisted)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of novice requesters in the assisted arm. Novice participants are defined has having less than 12 months of experience.
10954138|NCT00824616|OG001|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
10954139|NCT00824616|EG000|Reported Event|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
10954140|NCT00824616|EG001|Reported Event|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
10954141|NCT00824655|BG000|Baseline|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
10954142|NCT00824655|BG001|Baseline|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
10954143|NCT00824655|BG002|Baseline|Total|Total of all reporting groups
10954144|NCT00824655|FG000|Participant Flow|13vPnC/13vPnC|Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.
10954145|NCT00824655|FG001|Participant Flow|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
10954146|NCT00824655|OG000|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
10954147|NCT00824655|OG001|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
10954148|NCT00824655|EG000|Reported Event|13vPnC/13vPnC at 5 Months|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose)
10954149|NCT00824655|EG001|Reported Event|13vPnC/13vPnC at 6 Months of Age|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age).
10954150|NCT00824655|EG002|Reported Event|13vPnC/13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose).
10954151|NCT00824655|EG003|Reported Event|13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).
10954152|NCT00824720|BG000|Baseline|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
10954153|NCT00824720|BG001|Baseline|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
10954154|NCT00824720|BG002|Baseline|Placebo|punctal plug without bimatoprost
10954155|NCT00824720|BG003|Baseline|Total|Total of all reporting groups
10954156|NCT00824720|FG000|Participant Flow|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
10954157|NCT00824720|FG001|Participant Flow|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
10954158|NCT00824720|FG002|Participant Flow|Placebo|punctal plug without bimatoprost
10954159|NCT00824720|OG000|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
10954160|NCT00824720|OG001|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
10954161|NCT00824720|OG002|Outcome|Placebo|punctal plug without bimatoprost
10954162|NCT00824720|EG000|Reported Event|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
10954163|NCT00824720|EG001|Reported Event|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
10954164|NCT00824720|EG002|Reported Event|Placebo|punctal plug without bimatoprost
10954165|NCT00824733|BG000|Baseline|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
10954166|NCT00824733|FG000|Participant Flow|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
10954167|NCT00824733|OG000|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
10954168|NCT00824733|EG000|Reported Event|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
10954169|NCT00824746|BG000|Baseline|Single Arm|Gefitinib retreatment
10954170|NCT00824746|FG000|Participant Flow|Gefitinib Retreatment Group|Gefitinib retreatment group Patients who were previously treated with gefitinib followed by at least one line of cytotoxic chemotherapy can be enrolled to this retreatment group.
10954171|NCT00824746|OG000|Outcome|Gefitinib Retreatment Arm|Gefitinib retreatment arm
10954172|NCT00824746|OG000|Outcome|Gefitinib Retreatment Group|Gefitinib retreatment
10954173|NCT00824746|OG000|Outcome|Single Arm|Gefitinib retreatment
10954174|NCT00824746|EG000|Reported Event|Single Arm|Gefitinib retreatment
10954175|NCT00824772|BG000|Baseline|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
10954176|NCT00824772|FG000|Participant Flow|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
10954177|NCT00824772|OG000|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
10954178|NCT00824772|EG000|Reported Event|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
10954179|NCT00824824|BG000|Baseline|Primary Open Angle Glaucoma|Subjects of either gender with age range 40 to 80 years old with POAG were eligible for the study. Eligible subjects had a history of an untreated IOP > 21 mmHg in the left eye and a CPSD ≥ 1.0 in this eye. Patients being treated with more than two IOP lowering medications concurrently were excluded. All eligible subjects had open angles on gonioscopy with the filtering portion of the trabecular meshwork visible for 360° in both eyes. All subjects also had at least two reliable Humphrey 24-2 full threshold visual fields that showed reproducible loss in the left eye on tests with fixation loss ≤33%, false positives ≤ 20% and false negatives ≤ 20%. Patients with evidence of exfoliation or pigment dispersion syndrome in either eye were excluded. Subjects with diabetic retinopathy or a history of ocular laser or incisional surgery in either eye were also excluded.
11234377|NCT02434523|OG001|Outcome|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)~Placebo: Placebo pill"
10954180|NCT00824824|BG001|Baseline|POAG With RVD|7 subjects with POAG were identified to have retinal vascular dysregulation (RVD). We determined whether RVD was present in the following way. The percentage change between the retinal blood flow measured while reclining for 30 min and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the retinal blood flow while reclining compared to sitting was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ±2 standard deviations about the mean percentage change found in the control group in our previous study. Subjects with a change in retinal blood flow induced by posture change outside of -17.5% to +35.5% where considered to have RVD.
10954181|NCT00824824|BG002|Baseline|Total|Total of all reporting groups
10954182|NCT00824824|FG000|Participant Flow|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
10954183|NCT00824824|FG001|Participant Flow|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
10954184|NCT00824824|OG000|Outcome|Dorzolamide-Timolol|Post timolol-dorzolamide outcome: All 7 patients who had RVD following timolol had retinal vascular autoregulation that was in the normal range.
10954185|NCT00824824|OG001|Outcome|Brimonidine-Timolol|Post timolol-brimonidine outcome: 6 of the 7 patients were tested following timolol-brimonidine. One of the 7 patients could not be tested due to technical issues. Of the 6 that were tested, 4 patients had retinal vascular autoregulation that was in the normal range. Two patients continued to show RVD.
10954186|NCT00824824|EG000|Reported Event|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
10954187|NCT00824824|EG001|Reported Event|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
10954188|NCT00824850|BG000|Baseline|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
10954189|NCT00824850|BG001|Baseline|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
10954190|NCT00824850|BG002|Baseline|Total|Total of all reporting groups
10954191|NCT00824850|FG000|Participant Flow|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
10954192|NCT00824850|FG001|Participant Flow|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
10954193|NCT00824850|OG000|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
10954194|NCT00824850|OG001|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
10954195|NCT00824850|OG000|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
10954196|NCT00824850|OG001|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
10954197|NCT00824850|OG000|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
10954198|NCT00824850|OG001|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
10954199|NCT00824850|OG001|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
10954200|NCT00824850|OG001|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
10954201|NCT00824850|EG000|Reported Event|7vPnC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.~Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).~Other Adverse Events N=22; Local reactions N=38; Systemic events N=38."
11192321|NCT02138227|OG003|Outcome|Mid-Level Pre-Intervention Aggregate Relational Communication|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of mid-level requesters pre-intervention. Mid-level participants are defined has having 13 to 36 months of experience.
11192322|NCT02138227|OG004|Outcome|Mid-Level Post Intervention Relational Com (Autonomous)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of mid-level autonomous post-intervention autonomous arm. Mid-level participants are defined has having 13 to 36 months of experience.
10954202|NCT00824850|EG001|Reported Event|MnCC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.~Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).~Other Adverse Events N=20; Local reactions N=36; Systemic events N=36."
10954203|NCT00824993|BG000|Baseline|Ibandronate|One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
10954204|NCT00824993|BG001|Baseline|Control|Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
10954205|NCT00824993|BG002|Baseline|Total|Total of all reporting groups
10954206|NCT00824993|FG000|Participant Flow|Ibandronate|One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
10954207|NCT00824993|FG001|Participant Flow|Control|Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
10954208|NCT00824993|OG000|Outcome|Ibandronate|One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
10954209|NCT00824993|OG001|Outcome|Control|Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
10954210|NCT00824993|EG000|Reported Event|Ibandronate|One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
10954211|NCT00824993|EG001|Reported Event|Control|Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
10954212|NCT00825162|BG000|Baseline|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
10954213|NCT00825162|BG001|Baseline|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
11178643|NCT02049476|OG000|Outcome|Dexamethasone Pellet|"This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.~Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.~Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol."
11178644|NCT02049476|EG000|Reported Event|Dexamethasone Pellet|"This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.~Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.~Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol."
11178645|NCT02049502|BG000|Baseline|Fecal Microbiota Transplant|"fecal microbiota transplant~biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy~sigmoidoscopy"
11178646|NCT02049502|FG000|Participant Flow|Fecal Microbiota Transplant|"fecal microbiota transplant~biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy~sigmoidoscopy"
11178647|NCT02049502|OG000|Outcome|Fecal Microbiota Transplant|"fecal microbiota transplant~biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy~sigmoidoscopy"
11178648|NCT02049502|EG000|Reported Event|Fecal Microbiota Transplant|"fecal microbiota transplant~biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy~sigmoidoscopy"
11178649|NCT02049749|BG000|Baseline|No Intervention: Delayed CARE|40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired
11178650|NCT02049749|BG001|Baseline|Experiemental: Immediate CARE|80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE.
11178651|NCT02049749|BG002|Baseline|Total|Total of all reporting groups
10954214|NCT00825162|BG002|Baseline|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
10954215|NCT00825162|BG003|Baseline|Total|Total of all reporting groups
10954216|NCT00825162|FG000|Participant Flow|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
10954217|NCT00825162|FG001|Participant Flow|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
11178652|NCT02049749|FG000|Participant Flow|No Intervention: Delayed CARE|40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired.
11178653|NCT02049749|FG001|Participant Flow|Experimental: Immediate CARE|80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE.
11178654|NCT02049749|OG000|Outcome|No Intervention: Delayed CARE|40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired
11178655|NCT02049749|OG001|Outcome|Experiemental: Immediate CARE|80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE.
11192323|NCT02138227|OG005|Outcome|Mid-Level Post-Intervention Relational Com (Assisted)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of mid-level requesters in the autonomous post-intervention arm. Mid-level participants are defined has having 13 to 36 months of experience.
11192324|NCT02138227|OG006|Outcome|Senior Pre-Intervention Aggregate Relational Communication|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of senior requesters pre-intervention. Senior participants are defined has having more than 36 months of experience.
10954218|NCT00825162|FG002|Participant Flow|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
10954219|NCT00825162|OG000|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
10954220|NCT00825162|OG001|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
10954221|NCT00825162|OG000|Outcome|Cohort A|
10954222|NCT00825162|OG001|Outcome|Cohort B|
10954223|NCT00825162|OG002|Outcome|Cohort C|
10954224|NCT00825162|OG000|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
10954225|NCT00825162|OG001|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
10954226|NCT00825162|OG000|Outcome|Cohort C|Participants aged 9 to less than 18 years
10954227|NCT00825162|EG000|Reported Event|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
10954228|NCT00825162|EG001|Reported Event|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
10954229|NCT00825162|EG002|Reported Event|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
10954230|NCT00825175|BG000|Baseline|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
10954231|NCT00825175|BG001|Baseline|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
10954232|NCT00825175|BG002|Baseline|Total|Total of all reporting groups
10954233|NCT00825175|FG000|Participant Flow|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
10954234|NCT00825175|FG001|Participant Flow|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
10954235|NCT00825175|OG000|Outcome|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
10954236|NCT00825175|OG001|Outcome|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
10954237|NCT00825175|EG000|Reported Event|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
10954238|NCT00825175|EG001|Reported Event|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
10954239|NCT00825266|BG000|Baseline|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
10954240|NCT00825266|BG001|Baseline|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
10954241|NCT00825266|BG002|Baseline|Total|Total of all reporting groups
10954242|NCT00825266|FG000|Participant Flow|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg twice daily for 4 weeks, then 125mg BID for duration of study."
10954243|NCT00825266|FG001|Participant Flow|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
10954244|NCT00825266|OG000|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
10954245|NCT00825266|OG001|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
10954246|NCT00825266|EG000|Reported Event|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
10954247|NCT00825266|EG001|Reported Event|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
10954248|NCT00825305|BG000|Baseline|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
10954249|NCT00825305|BG001|Baseline|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
10954250|NCT00825305|BG002|Baseline|Total|Total of all reporting groups
10954251|NCT00825305|FG000|Participant Flow|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
10954252|NCT00825305|FG001|Participant Flow|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
10954253|NCT00825305|OG000|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
10954254|NCT00825305|OG001|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
10954255|NCT00825305|EG000|Reported Event|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
10954256|NCT00825305|EG001|Reported Event|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
10954257|NCT00825318|BG000|Baseline|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
10954258|NCT00825318|FG000|Participant Flow|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
10954259|NCT00825318|OG000|Outcome|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
10954260|NCT00825318|OG001|Outcome|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
10954261|NCT00825318|OG002|Outcome|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
10954262|NCT00825318|EG000|Reported Event|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
10954263|NCT00825318|EG001|Reported Event|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
10954264|NCT00825318|EG002|Reported Event|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
10954265|NCT00825344|BG000|Baseline|Group 1|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
10954266|NCT00825344|BG001|Baseline|Group 2|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
10954267|NCT00825344|BG002|Baseline|Total|Total of all reporting groups
10954268|NCT00825344|FG000|Participant Flow|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
10954269|NCT00825344|FG001|Participant Flow|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
10954270|NCT00825344|OG000|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
10954271|NCT00825344|OG001|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
10954272|NCT00825344|EG000|Reported Event|Group 1|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
10954273|NCT00825344|EG001|Reported Event|Group 2|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
10954274|NCT00825370|BG000|Baseline|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
10954275|NCT00825370|BG001|Baseline|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
10954276|NCT00825370|BG002|Baseline|Total|Total of all reporting groups
10954277|NCT00825370|FG000|Participant Flow|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
10954278|NCT00825370|FG001|Participant Flow|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
10954279|NCT00825370|OG000|Outcome|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
10954280|NCT00825370|OG001|Outcome|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
10954281|NCT00825370|EG000|Reported Event|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
10954282|NCT00825370|EG001|Reported Event|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
10954283|NCT00825500|BG000|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
10954284|NCT00825500|BG001|Baseline|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
10954285|NCT00825500|BG002|Baseline|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
10954286|NCT00825500|BG003|Baseline|Total|Total of all reporting groups
10954287|NCT00825500|FG000|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
10954288|NCT00825500|FG001|Participant Flow|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
10954289|NCT00825500|FG002|Participant Flow|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
10954290|NCT00825500|OG000|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
10954291|NCT00825500|OG001|Outcome|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
10954292|NCT00825500|OG002|Outcome|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
10954293|NCT00825500|EG000|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
10954294|NCT00825500|EG001|Reported Event|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
10954295|NCT00825500|EG002|Reported Event|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
10954296|NCT00825565|BG000|Baseline|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
10954297|NCT00825565|FG000|Participant Flow|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
10954298|NCT00825565|OG000|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
10954299|NCT00825565|OG000|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the target lesion area for assessing the impact on target wound closure.
10954300|NCT00825565|OG000|Outcome|Alwextin Cream|"8 subjects enrolled in this single study arm. All 8 subjects completed the study.~Alwextin cream: Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration."
10954301|NCT00825565|OG000|Outcome|Head/Neck|
10954302|NCT00825565|OG001|Outcome|Upper Limbs|
10954303|NCT00825565|OG002|Outcome|Trunk|
10954304|NCT00825565|OG003|Outcome|Lower Limbs|
10954305|NCT00825565|EG000|Reported Event|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
10954306|NCT00825630|BG000|Baseline|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
10954307|NCT00825630|BG001|Baseline|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
10954308|NCT00825630|BG002|Baseline|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
10954309|NCT00825630|BG003|Baseline|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
10954310|NCT00825630|BG004|Baseline|Total|Total of all reporting groups
10954311|NCT00825630|FG000|Participant Flow|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
10954312|NCT00825630|FG001|Participant Flow|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
10954313|NCT00825630|FG002|Participant Flow|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
10954314|NCT00825630|FG003|Participant Flow|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
10954315|NCT00825630|OG000|Outcome|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
10954316|NCT00825630|OG001|Outcome|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
10954317|NCT00825630|OG002|Outcome|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
10954318|NCT00825630|OG003|Outcome|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
10954319|NCT00825630|EG000|Reported Event|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
10954320|NCT00825630|EG001|Reported Event|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
10954321|NCT00825630|EG002|Reported Event|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
10954322|NCT00825630|EG003|Reported Event|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
10954323|NCT00825682|BG000|Baseline|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
10954324|NCT00825682|BG001|Baseline|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
10954325|NCT00825682|BG002|Baseline|Total|Total of all reporting groups
10954326|NCT00825682|FG000|Participant Flow|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
10954327|NCT00825682|FG001|Participant Flow|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
11234378|NCT02434523|EG000|Reported Event|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
10954328|NCT00825682|OG000|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
10954329|NCT00825682|OG001|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
10954330|NCT00825682|OG000|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. Five women did not begin the study and 8 women did not complete reflexology treatments due to personal reasons / inconvenience
10954331|NCT00825682|EG000|Reported Event|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
10954332|NCT00825682|EG001|Reported Event|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
10954333|NCT00825734|BG000|Baseline|All Patients|"Patients treated at all dose levels in the Phase I and Phase II portions of the study~: Dose Level 1 (4 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)~Dose Level -1 (3 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)~Dose Level 1a (76 patients) Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)"
10954334|NCT00825734|FG000|Participant Flow|Dose Level 1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)
10954335|NCT00825734|FG001|Participant Flow|Dose Level -1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)
10954336|NCT00825734|FG002|Participant Flow|Dose Level 1a|Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
10954337|NCT00825734|OG000|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
10954338|NCT00825734|OG000|Outcome|Phase II - Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
10954339|NCT00825734|EG000|Reported Event|Dose Level 1a|Includes patients treated at the Phase II dose - Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
10954340|NCT00825786|BG000|Baseline|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
10954341|NCT00825786|BG001|Baseline|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
10954342|NCT00825786|BG002|Baseline|Total|Total of all reporting groups
10954343|NCT00825786|FG000|Participant Flow|Treatment|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
10954344|NCT00825786|FG001|Participant Flow|Control|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
10954345|NCT00825786|OG000|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
10954346|NCT00825786|OG001|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
10954347|NCT00825786|EG000|Reported Event|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
10954348|NCT00825786|EG001|Reported Event|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
10954349|NCT00825812|BG000|Baseline|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
10954350|NCT00825812|BG001|Baseline|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
10954351|NCT00825812|BG002|Baseline|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
10954352|NCT00825812|BG003|Baseline|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
10954353|NCT00825812|BG004|Baseline|Total|Total of all reporting groups
10954354|NCT00825812|FG000|Participant Flow|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
10954355|NCT00825812|FG001|Participant Flow|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
10954356|NCT00825812|FG002|Participant Flow|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
10954357|NCT00825812|FG003|Participant Flow|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
11192325|NCT02138227|OG007|Outcome|Senior Post-Intervention Relational Communication (Autonomous)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of senior requesters in the autonomous post-intervention arm. Senior participants are defined has having more than 36 months of experience.
10954358|NCT00825812|OG000|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
10954359|NCT00825812|OG001|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
10954360|NCT00825812|OG002|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
10954361|NCT00825812|OG003|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
10954362|NCT00825812|EG000|Reported Event|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
10954363|NCT00825812|EG001|Reported Event|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
10954364|NCT00825812|EG002|Reported Event|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
10954365|NCT00825812|EG003|Reported Event|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
10954366|NCT00825825|BG000|Baseline|Entire Study Population|Includes all randomized subjects regardless of order in which they received medications
10954367|NCT00825825|FG000|Participant Flow|Escitalopram First / Citalopram Second / Placebo Third|2 weeks of escitalopram followed by 2 weeks of citalopram followed by 2 weeks of placebo
10954368|NCT00825825|FG001|Participant Flow|Escitalopram First / Placebo Second / Citalopram Third|2 weeks of escitalopram followed by 2 weeks of placebo followed by 2 weeks of citalopram
11192326|NCT02138227|OG008|Outcome|Senior Post-Intervention Relational Communication (Assisted)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of senior requesters in the assisted post-intervention arm. Senior participants are defined has having more than 36 months of experience.
10954369|NCT00825825|FG002|Participant Flow|Citalopram First / Escitalopram Second / Placebo Third|2 weeks of citalopram followed by 2 weeks of escitalopram followed by 2 weeks of placebo
10954370|NCT00825825|FG003|Participant Flow|Citalopram First / Placebo Second / Escitalopram Third|2 weeks of citalopram followed by 2 weeks of placebo followed by 2 weeks of escitalopram
10954371|NCT00825825|FG004|Participant Flow|Placebo First / Escitalopram Second / Citalopram Third|2 weeks of placebo followed by 2 weeks of escitalopram followed by 2 weeks of citalopram
10954372|NCT00825825|FG005|Participant Flow|Placebo First / Citalopram Second / Escitalopram Third|2 weeks of placebo followed by 2 weeks of citalopram followed by 2 weeks escitalopram
10954373|NCT00825825|OG000|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
10954374|NCT00825825|OG000|Outcome|All Participants With Complete Usuable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
10954375|NCT00825825|EG000|Reported Event|Escitalopram|Includes all subjects who received escitalopram in one of the three medication periods
10954376|NCT00825825|EG001|Reported Event|Citalopram|Includes all subjects who received citalopram in one of the three medication periods
10954377|NCT00825825|EG002|Reported Event|Placebo|Includes all subjects who received placebo in one of the three medication periods
11192327|NCT02138227|OG000|Outcome|Novice Pre-Intevention Aggregate Requester Comfort|Mean level of comfort with novice staff self-reported pre-intervention. Novice participants are defined has having less than 12 months of experience.
10954378|NCT00825916|BG000|Baseline|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954379|NCT00825916|BG001|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954380|NCT00825916|BG002|Baseline|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954381|NCT00825916|BG003|Baseline|Total|Total of all reporting groups
10954382|NCT00825916|FG000|Participant Flow|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954383|NCT00825916|FG001|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954384|NCT00825916|FG002|Participant Flow|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954385|NCT00825916|OG000|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954386|NCT00825916|OG001|Outcome|PSAS Results for 3 mg AZX100|This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954387|NCT00825916|OG002|Outcome|PSAS Results for 10 mg AZX100|This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954388|NCT00825916|OG003|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954389|NCT00825916|OG004|Outcome|OSAS Results for 3 mg AZX100|This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954390|NCT00825916|OG005|Outcome|OSAS Results for 10 mg AZX100|This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954391|NCT00825916|OG000|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954392|NCT00825916|OG001|Outcome|Rater 1 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954393|NCT00825916|OG002|Outcome|Rater 1 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954394|NCT00825916|OG003|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954395|NCT00825916|OG004|Outcome|Rater 2 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954396|NCT00825916|OG005|Outcome|Rater 2 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
11192328|NCT02138227|OG001|Outcome|Novice Post-Intervention Requester Comfort (Autonomous)|Mean level of comfort novice staff self-reported post- intervention in the autonomous arm. Novice participants are defined has having less than 12 months of experience.
10954397|NCT00825916|OG000|Outcome|Scar Length - Placebo|This group included Month 12 scar length (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954398|NCT00825916|OG001|Outcome|Scar Length - 3 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954399|NCT00825916|OG002|Outcome|Scar Length - 10 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954400|NCT00825916|OG003|Outcome|Scar Width - Placebo|This group included Month 12 scar width (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954401|NCT00825916|OG004|Outcome|Scar Width - 3 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954402|NCT00825916|OG005|Outcome|Scar Width - 10 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954403|NCT00825916|OG006|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954404|NCT00825916|OG007|Outcome|Scar Minimum Elevation - 3 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954405|NCT00825916|OG008|Outcome|Scar Minimum Elevation - 10 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954406|NCT00825916|OG009|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954407|NCT00825916|OG010|Outcome|Scar Maximum Elevation - 3 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954408|NCT00825916|OG011|Outcome|Scar Maximum Elevation - 10 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954409|NCT00825916|OG012|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954410|NCT00825916|OG013|Outcome|Scar Mean Elevation - 3 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954411|NCT00825916|OG014|Outcome|Scar Mean Elevation - 10 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
11234379|NCT02434523|EG001|Reported Event|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
10954412|NCT00825916|OG000|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954413|NCT00825916|OG001|Outcome|Scar Positive Volume - 3 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954414|NCT00825916|OG002|Outcome|Scar Positive Volume - 10 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954415|NCT00825916|OG003|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954416|NCT00825916|OG004|Outcome|Scar Negative Volume - 3 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954417|NCT00825916|OG005|Outcome|Scar Negative Volume - 10 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954418|NCT00825916|OG006|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954419|NCT00825916|OG007|Outcome|Scar Total Volume - 3 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
11178656|NCT02049749|OG001|Outcome|Experimental: Immediate CARE|80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE.
11178657|NCT02049749|EG000|Reported Event|No Intervention: Delayed CARE|40 child-caregiver pairs will be randomized to usual treatment plus delayed CARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed CARE) will receive the CARE training, if desired.
11178658|NCT02049749|EG001|Reported Event|Experiemental: Immediate CARE|80 child-caregiver pairs will be randomized to immediate CARE. Immediate CARE: CARE is a group parent training informed by the principles of Parent Child Interaction Therapy and was developed by Trauma Treatment Training Center and CHOP Policy Lab. CARE has been used in many populations including residential treatment center/domestic violence shelter staff, daycare providers, graduate students, biological parents, and foster parents/caseworkers. Goals are to decrease stress for caregivers, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. The training teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. The focus is on giving attention to child's pro-social behavior and ignoring minor misbehavior. The second phase teaches techniques for giving effective commands.
11178659|NCT02049814|BG000|Baseline|Metformin + Voglibose 0.2 mg|Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12.
11178660|NCT02049814|BG001|Baseline|Metformin + Acarbose 50 mg|Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12.
11178661|NCT02049814|BG002|Baseline|Total|Total of all reporting groups
11178662|NCT02049814|FG000|Participant Flow|Metformin + Voglibose 0.2 mg|Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12.
11178663|NCT02049814|FG001|Participant Flow|Metformin + Acarbose 50 mg|Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12.
11178664|NCT02049814|OG000|Outcome|Metformin + Voglibose 0.2 mg|Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12.
11178665|NCT02049814|OG001|Outcome|Metformin + Acarbose 50 mg|Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12.
11178666|NCT02049814|EG000|Reported Event|Metformin + Voglibose 0.2 mg|Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12.
11178667|NCT02049814|EG001|Reported Event|Metformin + Acarbose 50 mg|Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12.
11178668|NCT02049866|BG000|Baseline|Denosumab|"Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.~Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months"
11178669|NCT02049866|FG000|Participant Flow|Denosumab|"Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.~Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months"
11178670|NCT02049866|OG000|Outcome|Denosumab|"Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.~Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months"
11178671|NCT02049866|EG000|Reported Event|Denosumab|"Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.~Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months"
11178672|NCT02049931|BG000|Baseline|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
11178673|NCT02049931|BG001|Baseline|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
11192329|NCT02138227|OG002|Outcome|Novice Post-Intervention Requester Comfort (Assisted)|Mean level of comfort novice staff self-reported post-intervention in the assisted arm. Novice participants are defined has having less than 12 months of experience.
10954420|NCT00825916|OG008|Outcome|Scar Total Volume - 10 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954421|NCT00825916|EG000|Reported Event|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954422|NCT00825916|EG001|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954423|NCT00825916|EG002|Reported Event|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10954424|NCT00825994|BG000|Baseline|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
10954425|NCT00825994|FG000|Participant Flow|Omega-3|omega-3 fatty acids, 2g qd [every day] (2 x 1 gram tablets), PO [by mouth]
10954426|NCT00825994|OG000|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
10954427|NCT00825994|EG000|Reported Event|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
10954428|NCT00826007|BG000|Baseline|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
10954429|NCT00826007|BG001|Baseline|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
11178674|NCT02049931|BG002|Baseline|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
11178675|NCT02049931|BG003|Baseline|Total|Total of all reporting groups
10954430|NCT00826007|BG002|Baseline|Total|Total of all reporting groups
10954431|NCT00826007|FG000|Participant Flow|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
10954432|NCT00826007|FG001|Participant Flow|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
10954433|NCT00826007|OG000|Outcome|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
10954434|NCT00826007|OG001|Outcome|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
10954435|NCT00826007|EG000|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
10954436|NCT00826020|BG000|Baseline|Omegaven™|"This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.~Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours."
10954437|NCT00826020|FG000|Participant Flow|Omegaven™|"This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.~Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours."
10954438|NCT00826020|OG000|Outcome|Omegaven™|"This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.~Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours."
10954439|NCT00826020|EG000|Reported Event|Omegaven™|"This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.~Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours."
10954440|NCT00826111|BG000|Baseline|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
10954441|NCT00826111|BG001|Baseline|Placebo|Escitalopram with placebo
10954442|NCT00826111|BG002|Baseline|Total|Total of all reporting groups
10954443|NCT00826111|FG000|Participant Flow|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
10954444|NCT00826111|FG001|Participant Flow|Placebo|Escitalopram with placebo
11178676|NCT02049931|FG000|Participant Flow|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
10954445|NCT00826111|OG000|Outcome|Eszopiclone|Open label escitalopram for 10 weeks together with 3 mg eszopiclone for eight weeks followed by placebo for two weeks.
10954446|NCT00826111|OG001|Outcome|Placebo|Open label escitalopram for 10 weeks together with placebo for 10 weeks.
11178677|NCT02049931|FG001|Participant Flow|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
11178678|NCT02049931|FG002|Participant Flow|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
11178679|NCT02049931|OG000|Outcome|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
11178680|NCT02049931|OG001|Outcome|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
11178681|NCT02049931|OG002|Outcome|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
11178682|NCT02049931|EG000|Reported Event|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
11178683|NCT02049931|EG001|Reported Event|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
11178684|NCT02049931|EG002|Reported Event|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
11178685|NCT02049944|BG000|Baseline|3g Cefazolin|3g IV cefazolin given 30-60 minutes prior to skin incision
11178686|NCT02049944|FG000|Participant Flow|3g Cefazolin|Prospective cohort obese women receiving 3g prophylactic cefazolin 30-60 minutes prior to scheduled cesarean delivery
11178687|NCT02049944|OG000|Outcome|3g Cefazolin|Prospective cohort obese women receiving 3g prophylactic cefazolin 30-60 minutes prior to scheduled cesarean delivery
11178688|NCT02049944|EG000|Reported Event|3g Cefazolin|3g cefazolin provided via IV push 30-60 minutes prior to skin incision
11178689|NCT02049957|BG000|Baseline|Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane|Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).
11178690|NCT02049957|BG001|Baseline|Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant|Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).
11178691|NCT02049957|BG002|Baseline|Phase 1 (Part 2): Sapanisertib 3 mg + Exemestane|Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 8 cycles).
11178692|NCT02049957|BG003|Baseline|Phase 1 (Part 2): Sapanisertib 3 mg + Fulvestrant|Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle up to 14 cycles plus fulvestrant 500 mg, injection, IM, once on Day 1 of each cycle (Up to 14 cycles).
11178693|NCT02049957|BG004|Baseline|Phase 1 (Part 2): Sapanisertib 4 mg + Exemestane|Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 18 cycles).
11178694|NCT02049957|BG005|Baseline|Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Sensitive)|Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 14 cycles) in everolimus sensitive participants.
11178695|NCT02049957|BG006|Baseline|Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Sensitive)|Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 17 cycles) in everolimus sensitive participants.
11178696|NCT02049957|BG007|Baseline|Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Resistant)|Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles) in everolimus resistant participants.
11178697|NCT02049957|BG008|Baseline|Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Resistant)|Sapanisertib 4 mg, milled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 9 cycles) in everolimus resistant participants.
10954447|NCT00826111|OG000|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
10954448|NCT00826111|OG001|Outcome|Placebo|Escitalopram with placebo
10954449|NCT00826111|OG000|Outcome|Eszopiclone|Escitalopram for 10 weeks together with eszopiclone.
10954450|NCT00826111|EG000|Reported Event|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
10954451|NCT00826111|EG001|Reported Event|Placebo|Escitalopram with placebo
10954452|NCT00826150|BG000|Baseline|BC-819 60 mp IP|60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954453|NCT00826150|BG001|Baseline|BC-819 120 mg IP|120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954454|NCT00826150|BG002|Baseline|BC-819 240 mg IP|240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954455|NCT00826150|BG003|Baseline|Total|Total of all reporting groups
10954456|NCT00826150|FG000|Participant Flow|BC-819 60 mg IP|60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses/ 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954457|NCT00826150|FG001|Participant Flow|BC-819 120 mg IP|120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954458|NCT00826150|FG002|Participant Flow|BC-819 240 mg IP|240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
11178698|NCT02049957|BG009|Baseline|Total|Total of all reporting groups
11178699|NCT02049957|FG000|Participant Flow|Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane|Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).
10954459|NCT00826150|OG000|Outcome|BC-819 60 mg IP|60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954460|NCT00826150|OG001|Outcome|BC-819 120 mg IP|120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954461|NCT00826150|OG002|Outcome|BC-819 240 mg IP|240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954462|NCT00826150|OG000|Outcome|BC-819 60 mp IP|60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954463|NCT00826150|OG000|Outcome|BC-819 60 mg IP|60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses/ 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954464|NCT00826150|EG000|Reported Event|BC-819 60 mg IP|60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954465|NCT00826150|EG001|Reported Event|BC-819 120 mg IP|120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954466|NCT00826150|EG002|Reported Event|BC-819 240 mg IP|120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
10954467|NCT00826176|BG000|Baseline|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
10954468|NCT00826176|BG001|Baseline|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
10954469|NCT00826176|BG002|Baseline|Total|Total of all reporting groups
10954470|NCT00826176|FG000|Participant Flow|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
10954471|NCT00826176|FG001|Participant Flow|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
10954472|NCT00826176|OG000|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
10954473|NCT00826176|OG001|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
10954474|NCT00826176|EG000|Reported Event|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
10954475|NCT00826176|EG001|Reported Event|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
10954476|NCT00826202|BG000|Baseline|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
10954477|NCT00826202|BG001|Baseline|Placebo|Placebo: Inert Placebo
10954478|NCT00826202|BG002|Baseline|Total|Total of all reporting groups
10954479|NCT00826202|FG000|Participant Flow|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
10954480|NCT00826202|FG001|Participant Flow|Placebo|Placebo: Inert Placebo
10954481|NCT00826202|OG000|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
10954482|NCT00826202|OG001|Outcome|Placebo|Placebo: Inert Placebo
10954483|NCT00826202|EG000|Reported Event|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
10954484|NCT00826202|EG001|Reported Event|Placebo|Placebo: Inert Placebo
10954485|NCT00826228|BG000|Baseline|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
10954486|NCT00826228|FG000|Participant Flow|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing on a Lokomat
10954487|NCT00826228|OG000|Outcome|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
10954488|NCT00826228|OG000|Outcome|PTH/Weight-Bearing|
10954489|NCT00826228|EG000|Reported Event|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
10954490|NCT00826241|BG000|Baseline|Temozolomide + Lapatinib|"Temozolomide starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle. Lapatinib starting dose 1250 mg daily by mouth.~Temozolomide: Starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle.~Lapatinib: Starting dose 1250 mg daily by mouth."
11178700|NCT02049957|FG001|Participant Flow|Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant|Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).
11178701|NCT02049957|FG002|Participant Flow|Phase 1 (Part 2): Sapanisertib 3 mg + Exemestane|Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 8 cycles).
11192330|NCT02138227|OG003|Outcome|Mid-Level Pre-Intervention Aggregate Requester Comfort|Mean level of comfort mid-level staff self-reported pre-intervention. Mid-level participants are defined has having more 13 to 36 months of experience.
10954491|NCT00826241|FG000|Participant Flow|Temozolomide + Lapatinib|"Temozolomide starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle. Lapatinib starting dose 1250 mg daily by mouth.~Temozolomide: Starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle.~Lapatinib: Starting dose 1250 mg daily by mouth."
10954492|NCT00826241|OG000|Outcome|Temozolomide + Lapatinib|"Temozolomide starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle. Lapatinib starting dose 1250 mg daily by mouth.~Temozolomide: Starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle.~Lapatinib: Starting dose 1250 mg daily by mouth."
10954493|NCT00826241|EG000|Reported Event|Temozolomide + Lapatinib|"Temozolomide starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle. Lapatinib starting dose 1250 mg daily by mouth.~Temozolomide: Starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle.~Lapatinib: Starting dose 1250 mg daily by mouth."
10954494|NCT00826267|BG000|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
10954495|NCT00826267|BG001|Baseline|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
10954496|NCT00826267|BG002|Baseline|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
10954497|NCT00826267|BG003|Baseline|Total|Total of all reporting groups
10954498|NCT00826267|FG000|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
10954499|NCT00826267|FG001|Participant Flow|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
10954500|NCT00826267|FG002|Participant Flow|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
10954501|NCT00826267|OG000|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
11234380|NCT02434770|BG000|Baseline|BBIBP bOPV Lot 1|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
11234381|NCT02434770|BG001|Baseline|BBIBP bOPV Lot 2|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
10954502|NCT00826267|OG001|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
10954503|NCT00826267|OG002|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
10954504|NCT00826267|OG000|Outcome|Afatinib 50mg|Patients received Afatinib 50 mg at day 7.
10954505|NCT00826267|EG000|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
10954506|NCT00826267|EG001|Reported Event|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
10954507|NCT00826267|EG002|Reported Event|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
10954508|NCT00826280|BG000|Baseline|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
10954509|NCT00826280|BG001|Baseline|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
10954510|NCT00826280|BG002|Baseline|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
10954511|NCT00826280|BG003|Baseline|Total|Total of all reporting groups
10954512|NCT00826280|FG000|Participant Flow|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
10954513|NCT00826280|FG001|Participant Flow|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
10954514|NCT00826280|FG002|Participant Flow|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
10954515|NCT00826280|OG000|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
10954516|NCT00826280|OG001|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
10954517|NCT00826280|OG002|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
10954518|NCT00826280|EG000|Reported Event|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
10954519|NCT00826280|EG001|Reported Event|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
10954520|NCT00826280|EG002|Reported Event|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
10954521|NCT00826449|BG000|Baseline|Dasatinib + Erlotinib: Phase I|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
10954522|NCT00826449|BG001|Baseline|Dasatinib + Erlotinib: Phase 2|MTD from Phase I Dasatinib orally dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
10954523|NCT00826449|BG002|Baseline|Total|Total of all reporting groups
10954524|NCT00826449|FG000|Participant Flow|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
10954525|NCT00826449|OG000|Outcome|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
10954526|NCT00826449|OG000|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
10954527|NCT00826449|EG000|Reported Event|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
10954528|NCT00826514|BG000|Baseline|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
10954529|NCT00826514|BG001|Baseline|Placebo|A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
10954530|NCT00826514|BG002|Baseline|Total|Total of all reporting groups
10954531|NCT00826514|FG000|Participant Flow|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
10954532|NCT00826514|FG001|Participant Flow|Placebo|A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
10954533|NCT00826514|OG000|Outcome|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
10954534|NCT00826514|OG001|Outcome|Placebo|A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
10954535|NCT00826514|EG000|Reported Event|Tanezumab|A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
10954536|NCT00826514|EG001|Reported Event|Placebo|A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
10954537|NCT00826540|BG000|Baseline|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies> > sorafenib tosylate: Given orally>~> bevacizumab: Given IV"
10954538|NCT00826540|FG000|Participant Flow|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies> > sorafenib tosylate: Given orally>~> bevacizumab: Given IV"
10954539|NCT00826540|OG000|Outcome|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies >~> sorafenib tosylate: Given orally~>~> bevacizumab: Given IV"
10954540|NCT00826540|EG000|Reported Event|Treatment (Sorafenib Tosylate and Bevacizumab)|bevacizumab: Given IV
10954541|NCT00826618|BG000|Baseline|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
10954542|NCT00826618|FG000|Participant Flow|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
10954543|NCT00826618|OG000|Outcome|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. Mean change in BCVA (assessed by the ETDRS chart at 4 m) from baseline at 12 months was 12.2 ETDRS letters (P = 0.015).
10954544|NCT00826618|EG000|Reported Event|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
10954545|NCT00826748|BG000|Baseline|Treated Smokers|The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
10954546|NCT00826748|BG001|Baseline|Non-Treated Smokers|Non-Treated Smokers will act as a control and includes healthy smokers who received no treatment.
10954547|NCT00826748|BG002|Baseline|Non-smokers|Non-Smokers will act as a control and includes healthy non-smokers who received no treatment.
10954548|NCT00826748|BG003|Baseline|Total|Total of all reporting groups
10954549|NCT00826748|FG000|Participant Flow|Treated Smokers|The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
10954550|NCT00826748|FG001|Participant Flow|Non-Treated Smokers|Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
10954551|NCT00826748|FG002|Participant Flow|Non-Smokers|Non-Smokers will act as control and include healthy non-smokers who receive no treatment.
10954552|NCT00826748|OG000|Outcome|Treated Smokers|The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days
10954553|NCT00826748|OG001|Outcome|Non-Treated Smokers|Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
10954554|NCT00826748|OG002|Outcome|Non-Smokers|Non-Smokers will act as control and include healthy non-smokers who receive no treatment. Two subjects withdrew consent prior to the Day 7 timepoint, therefore only 10 subjects have data available past Day 7.
10954555|NCT00826748|EG000|Reported Event|Treated Smokers|Treated Smokers will be administered with 320 micrograms (mcg) of beclomethasone daily from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. The dose will be 2 puffs twice a day for 7 days.
10954556|NCT00826748|EG001|Reported Event|Non-Treated Smokers|Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
10954557|NCT00826748|EG002|Reported Event|Non-smokers|Non-Smokers will act as control and include healthy non-smokers who receive no treatment.
10954558|NCT00826800|BG000|Baseline|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
10954559|NCT00826800|FG000|Participant Flow|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
10954560|NCT00826800|OG000|Outcome|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
10954561|NCT00826800|EG000|Reported Event|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
10954562|NCT00826943|BG000|Baseline|All Study Participants|Cross Over (all participants received all interventions)
10954563|NCT00826943|FG000|Participant Flow|L Then C Then P|Levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
10954564|NCT00826943|FG001|Participant Flow|L Then P Then C|Levocetirizine 5 mg daily x 7 days then placebo daily x 7 days then cetiriznie 10 mg daily x 7 days (wash out periods before and after each)
10954565|NCT00826943|FG002|Participant Flow|P Then L Then C|placebo daily x 7 days then levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days (wash out periods before and after each)
10954566|NCT00826943|FG003|Participant Flow|P Then C Then L|placebo daily x 7 days then cetirizine 10 mg daily x 7 days then levocetirizine daily x 7 days (wash out periods before and after each)
10954567|NCT00826943|FG004|Participant Flow|C Then L Then P|cetirizine 10 mg daily x 7 days then levocetirizine 5 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
10954568|NCT00826943|FG005|Participant Flow|C Then P Then L|cetirizine 10 mg daily x 7 days then placebo daily x 7 days then levocetirizine 5 mg daily x 7 days (wash out periods before and after each)
10954569|NCT00826943|OG000|Outcome|Placebo|Cross Over (all participants received all interventions)
10954570|NCT00826943|OG001|Outcome|Levocetirizine|cross over (all participants received all interventions)
10954571|NCT00826943|OG002|Outcome|Cetirizine|cross over = all participants received all interventions
10954572|NCT00826943|EG000|Reported Event|Placebo|Cross Over (all participants received all interventions)
10954573|NCT00826943|EG001|Reported Event|Levocetirizine|cross over (all participants received all interventions)
10954574|NCT00826943|EG002|Reported Event|Cetirizine|cross over = all participants received all interventions
10954575|NCT00827073|BG000|Baseline|Tetracaine 5% Drop|"betadine: betadine 5%~topical anesthetic"
10954576|NCT00827073|BG001|Baseline|Lidocaine 2% Jelly|"betadine: betadine 5%~anesthetic"
10954577|NCT00827073|BG002|Baseline|Total|Total of all reporting groups
10954578|NCT00827073|FG000|Participant Flow|Tetracaine 5% Drop|betadine: betadine 5%, topical anesthetic drop
10954579|NCT00827073|FG001|Participant Flow|Lidocaine 2% Jelly|betadine: betadine 5% Anesthetic: lidocaine 2% jelly
10954580|NCT00827073|OG000|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%~topical anesthetic"
10954581|NCT00827073|OG001|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
10954582|NCT00827073|EG000|Reported Event|Tetracaine 0.5% Drop|"betadine: betadine 5%~Topical Anesthetic"
10954583|NCT00827073|EG001|Reported Event|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
10954584|NCT00827099|BG000|Baseline|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
10954585|NCT00827099|FG000|Participant Flow|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
10954586|NCT00827099|OG000|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
10954587|NCT00827099|EG000|Reported Event|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
10954588|NCT00827112|BG000|Baseline|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
10954589|NCT00827112|BG001|Baseline|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
10954590|NCT00827112|BG002|Baseline|Total|Total of all reporting groups
10954591|NCT00827112|FG000|Participant Flow|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
10954592|NCT00827112|FG001|Participant Flow|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
10954593|NCT00827112|OG000|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
10954594|NCT00827112|OG001|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
10954595|NCT00827112|EG000|Reported Event|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks.
10954596|NCT00827112|EG001|Reported Event|Atazanavir / Ritonavir + Emtricitabine/ Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
10954597|NCT00827242|BG000|Baseline|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
10954598|NCT00827242|BG001|Baseline|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
10954599|NCT00827242|BG002|Baseline|Total|Total of all reporting groups
10954600|NCT00827242|FG000|Participant Flow|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
10954601|NCT00827242|FG001|Participant Flow|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
10954602|NCT00827242|OG000|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
10954603|NCT00827242|OG001|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
10954604|NCT00827242|EG000|Reported Event|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
10954605|NCT00827242|EG001|Reported Event|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
10954606|NCT00827255|BG000|Baseline|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
10954607|NCT00827255|FG000|Participant Flow|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
10954608|NCT00827255|OG000|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
11234382|NCT02434770|BG002|Baseline|BioFarma bOPV|Infants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
11234383|NCT02434770|BG003|Baseline|Total|Total of all reporting groups
10954609|NCT00827255|EG000|Reported Event|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
10954610|NCT00827359|BG000|Baseline|Treatment|"This is a single-arm study. All patients will receive everolimus.~Everolimus: Tablet form taken orally once a day"
10954611|NCT00827359|FG000|Participant Flow|Treatment|"This is a single-arm study. All patients will receive everolimus.~Everolimus: Tablet form taken orally once a day"
10954612|NCT00827359|OG000|Outcome|Treatment|"This is a single-arm study. All patients will receive everolimus.~Everolimus: Tablet form taken orally once a day"
10954613|NCT00827359|EG000|Reported Event|Treatment|"This is a single-arm study. All patients will receive everolimus.~Everolimus: Tablet form taken orally once a day"
10954614|NCT00827372|BG000|Baseline|Overall Study|All patients who were treated
10954615|NCT00827372|FG000|Participant Flow|Overall Study|All patients who were treated
10954616|NCT00827372|OG000|Outcome|Overall Study|All patients who were treated
10954617|NCT00827372|OG000|Outcome|Overall|All patients who were treated
10954618|NCT00827372|EG000|Reported Event|Overall|All patients who were treated
10954619|NCT00827502|BG000|Baseline|Azithromycin|
10954620|NCT00827502|FG000|Participant Flow|Azithromycin|The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.
10954621|NCT00827502|OG000|Outcome|Azithromycin|
10954622|NCT00827502|EG000|Reported Event|Azithromycin|
10954623|NCT00827541|BG000|Baseline|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
10954624|NCT00827541|BG001|Baseline|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
10954625|NCT00827541|BG002|Baseline|Total|Total of all reporting groups
10954626|NCT00827541|FG000|Participant Flow|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
10954627|NCT00827541|FG001|Participant Flow|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
10954628|NCT00827541|OG000|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
10954629|NCT00827541|OG001|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
10954630|NCT00827541|EG000|Reported Event|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
10954631|NCT00827541|EG001|Reported Event|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
10954632|NCT00827606|BG000|Baseline|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954633|NCT00827606|BG001|Baseline|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954634|NCT00827606|BG002|Baseline|Total|Total of all reporting groups
10954635|NCT00827606|FG000|Participant Flow|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (PO), through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target low-density lipoprotein cholesterol (LDL-C) (<3.35 millimoles per liter [mmol/L]) was not attained.
10954636|NCT00827606|FG001|Participant Flow|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged greater than or equal to (≥) 10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
11178702|NCT02049957|FG003|Participant Flow|Phase 1 (Part 2): Sapanisertib 3 mg + Fulvestrant|Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle up to 14 cycles plus fulvestrant 500 mg, injection, IM, once on Day 1 of each cycle (Up to 14 cycles).
10954637|NCT00827606|OG000|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954638|NCT00827606|OG001|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954639|NCT00827606|OG000|Outcome|Atorvastatin (5-80 mg): Baseline Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954640|NCT00827606|OG001|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 2|Participants aged ≥10 to 15 years, at Tanner_Stage 2 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954641|NCT00827606|OG002|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 3|Participants aged ≥10 to 15 years, at Tanner_Stage 3 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954642|NCT00827606|OG003|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 4|Participants aged ≥10 to 15 years, at Tanner_Stage 4 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954643|NCT00827606|OG004|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 5|Participants aged ≥10 to 15 years, at Tanner_Stage 5 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
11178703|NCT02049957|FG004|Participant Flow|Phase 1 (Part 2): Sapanisertib 4 mg + Exemestane|Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 18 cycles).
11178704|NCT02049957|FG005|Participant Flow|Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Sensitive)|Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 14 cycles) in everolimus sensitive participants.
10954644|NCT00827606|OG000|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954645|NCT00827606|EG000|Reported Event|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954646|NCT00827606|EG001|Reported Event|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
10954647|NCT00827632|BG000|Baseline|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
10954648|NCT00827632|BG001|Baseline|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
10954649|NCT00827632|BG002|Baseline|Total|Total of all reporting groups
10954650|NCT00827632|FG000|Participant Flow|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
10954651|NCT00827632|FG001|Participant Flow|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
10954652|NCT00827632|OG000|Outcome|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
10954653|NCT00827632|OG001|Outcome|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
10954654|NCT00827632|EG000|Reported Event|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
10954655|NCT00827632|EG001|Reported Event|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
10954656|NCT00827775|BG000|Baseline|Control|Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions
10954657|NCT00827775|BG001|Baseline|Intervention|"Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions~Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid"
10954658|NCT00827775|BG002|Baseline|Total|Total of all reporting groups
10954659|NCT00827775|FG000|Participant Flow|Control|Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions
10954660|NCT00827775|FG001|Participant Flow|Intervention|"Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions~Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid"
10954661|NCT00827775|OG000|Outcome|Control|Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions
10954662|NCT00827775|OG001|Outcome|Intervention|"Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions~Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid"
10954663|NCT00827775|EG000|Reported Event|Control|Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions
10954664|NCT00827775|EG001|Reported Event|Intervention|"Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions~Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid"
10954665|NCT00827827|BG000|Baseline|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
10954666|NCT00827827|BG001|Baseline|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
10954667|NCT00827827|BG002|Baseline|Total|Total of all reporting groups
10954668|NCT00827827|FG000|Participant Flow|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
10963736|NCT00873912|BG000|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
10954669|NCT00827827|FG001|Participant Flow|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
10954670|NCT00827827|OG000|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
10954671|NCT00827827|OG001|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
10954672|NCT00827827|OG001|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
10954673|NCT00827827|EG000|Reported Event|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
10954674|NCT00827827|EG001|Reported Event|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
10954675|NCT00827918|BG000|Baseline|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
10954676|NCT00827918|BG001|Baseline|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
10954677|NCT00827918|BG002|Baseline|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
10954678|NCT00827918|BG003|Baseline|Total|Total of all reporting groups
10954679|NCT00827918|FG000|Participant Flow|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
10954680|NCT00827918|FG001|Participant Flow|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
10954681|NCT00827918|FG002|Participant Flow|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
10954682|NCT00827918|OG000|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
10954683|NCT00827918|OG001|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
10954684|NCT00827918|OG002|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
10954685|NCT00827918|EG000|Reported Event|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
10954686|NCT00827918|EG001|Reported Event|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
10954687|NCT00827918|EG002|Reported Event|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
10954688|NCT00827931|BG000|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
10954689|NCT00827931|BG001|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
11234384|NCT02434770|FG000|Participant Flow|BBIBP bOPV Lot 1|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
10954690|NCT00827931|BG002|Baseline|Total|Total of all reporting groups
10954691|NCT00827931|FG000|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
10954692|NCT00827931|FG001|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
10954693|NCT00827931|OG000|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
10954694|NCT00827931|OG001|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
10954695|NCT00827931|EG000|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
10954696|NCT00827931|EG001|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
10954697|NCT00827944|BG000|Baseline|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
10954698|NCT00827944|BG001|Baseline|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
10954699|NCT00827944|BG002|Baseline|Total|Total of all reporting groups
10954700|NCT00827944|FG000|Participant Flow|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
10954701|NCT00827944|FG001|Participant Flow|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
10954702|NCT00827944|OG000|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
10954703|NCT00827944|OG001|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
10954704|NCT00827944|EG000|Reported Event|Progrip Group|"Parietex ProGrip~Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
10954705|NCT00827944|EG001|Reported Event|Lichtenstein Group|"Low weight polypropylene mesh~Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
10954706|NCT00827983|BG000|Baseline|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
10954707|NCT00827983|BG001|Baseline|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
10954708|NCT00827983|BG002|Baseline|Total|Total of all reporting groups
10954709|NCT00827983|FG000|Participant Flow|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
10954710|NCT00827983|FG001|Participant Flow|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
10954711|NCT00827983|OG000|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
11234385|NCT02434770|FG001|Participant Flow|BBIBP bOPV Lot 2|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
10954712|NCT00827983|OG001|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
10954713|NCT00827983|EG000|Reported Event|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
10954714|NCT00827983|EG001|Reported Event|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
10954715|NCT00828009|BG000|Baseline|Step 2 - Maintenance Therapy|Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
10954716|NCT00828009|FG000|Participant Flow|Tecemotide/Bevacizumab After Chemoradiation|"Concomitant Chemoradiotherapy: Patients (pts) receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 15-30 minutes weekly for 6 weeks. Pts also receive radiotherapy 5 days a week for 6½ weeks. Pts with CR, PR, or SD proceed to consolidation chemotherapy.~Consolidation chemotherapy: Pts receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression (PD) or unacceptable toxicity. Pts with CR, PR, or SD proceed to maintenance therapy.~Maintenance therapy: Pts receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and tecemotide. Pts then receive bevacizumab IV over 30-90 minutes on day 1 and tecemotide subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of PD or unacceptable toxicity."
10954717|NCT00828009|OG000|Outcome|Step 2 - Maintenance Therapy|Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
10963737|NCT00873912|BG001|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
10963738|NCT00873912|BG002|Baseline|Total|Total of all reporting groups
10954718|NCT00828009|EG000|Reported Event|Step 1 - Chemoradiation and Consolidation Chemotherapy|"Chemoradiotherapy: Patients receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 15-30 minutes once a week for 6 weeks. Patients also undergo concurrent definitive radiotherapy 5 days a week for 6½ weeks. Patients with complete response (CR), partial response (PR), or stable disease (SD) proceed to consolidation chemotherapy.~Consolidation chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with CR, PR, or SD proceed to maintenance therapy."
10954719|NCT00828009|EG001|Reported Event|Step 2 - Maintenance Therapy|Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
10954720|NCT00828061|BG000|Baseline|All Patients|All patients who completed at least one period are included in the analysis
10954721|NCT00828061|FG000|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 10 mg prednisone, 1 day 25 mg prednisone
10954722|NCT00828061|FG001|Participant Flow|Prednisone / Prednisone / Placebo|1 day 10 mg prednisone, 1 day 25 mg prednisone, 1 day placebo
10954723|NCT00828061|FG002|Participant Flow|Prednisone / Placebo / Prednisone|1 day 25 mg prednisone, 1 day placebo, 1 day 10 mg prednisone
10954724|NCT00828061|FG003|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 25 mg prednisone, 1 day 10 mg prednisone
10954725|NCT00828061|FG004|Participant Flow|Prednisone / Placebo / Prednisone|1 day 10 mg prednisone, 1 day placebo, 1 day 25 mg prednisone
11178705|NCT02049957|FG006|Participant Flow|Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Sensitive)|Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 17 cycles) in everolimus sensitive participants.
10954726|NCT00828061|FG005|Participant Flow|Prednisone / Prednisone / Placebo|1 day 25 mg prednisone, 1 day 10 mg prednisone, 1 day placebo
10954727|NCT00828061|OG000|Outcome|Placebo|
10954728|NCT00828061|OG001|Outcome|10 mg Prednisone|
10954729|NCT00828061|OG002|Outcome|25 mg Prednisone|
11178706|NCT02049957|FG007|Participant Flow|Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Resistant)|Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles) in everolimus resistant participants.
11178707|NCT02049957|FG008|Participant Flow|Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Resistant)|Sapanisertib 4 mg, milled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 9 cycles) in everolimus resistant participants.
11178708|NCT02049957|OG000|Outcome|Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane|Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).
10954730|NCT00828061|EG000|Reported Event|Placebo|
10954731|NCT00828061|EG001|Reported Event|10 mg Prednisone|
10954732|NCT00828061|EG002|Reported Event|25 mg Prednisone|
10954733|NCT00828074|BG000|Baseline|Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
10954734|NCT00828074|BG001|Baseline|Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
10954735|NCT00828074|BG002|Baseline|Total|Total of all reporting groups
10954736|NCT00828074|FG000|Participant Flow|Phase I - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
10954737|NCT00828074|FG001|Participant Flow|Phase I - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
10954738|NCT00828074|FG002|Participant Flow|Phase II - Vinorelbine 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
10954739|NCT00828074|OG000|Outcome|Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
10954740|NCT00828074|OG001|Outcome|Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
10954741|NCT00828074|OG000|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
10954742|NCT00828074|OG000|Outcome|Dose Level II - Vinorelbine I.V. 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
10954743|NCT00828074|OG000|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
10954744|NCT00828074|OG000|Outcome|Phase I & II|"Patients receive sorafenib tosylate PO twice daily on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Dose level 1 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 2 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle.~vinorelbine ditartrate: Dose level 1 = 20 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 2 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle."
10954745|NCT00828074|EG000|Reported Event|Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
10954746|NCT00828074|EG001|Reported Event|Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
11178709|NCT02049957|OG001|Outcome|Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant|Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).
11234386|NCT02434770|FG002|Participant Flow|BioFarma bOPV|Infants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
10954747|NCT00828113|BG000|Baseline|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
10954748|NCT00828113|BG001|Baseline|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
10954749|NCT00828113|BG002|Baseline|Total|Total of all reporting groups
10954750|NCT00828113|FG000|Participant Flow|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
10954751|NCT00828113|FG001|Participant Flow|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
10954752|NCT00828113|OG000|Outcome|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
10954753|NCT00828113|OG001|Outcome|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
10954754|NCT00828113|EG000|Reported Event|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
10954755|NCT00828113|EG001|Reported Event|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
10954756|NCT00828139|BG000|Baseline|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
10954757|NCT00828139|BG001|Baseline|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
10954758|NCT00828139|BG002|Baseline|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
10954759|NCT00828139|BG003|Baseline|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
10954760|NCT00828139|BG004|Baseline|Total|Total of all reporting groups
10954761|NCT00828139|FG000|Participant Flow|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
10954762|NCT00828139|FG001|Participant Flow|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
10954763|NCT00828139|FG002|Participant Flow|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
10954764|NCT00828139|FG003|Participant Flow|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
10954765|NCT00828139|OG000|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
10954766|NCT00828139|OG001|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
10954767|NCT00828139|OG002|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
11234387|NCT02434770|OG000|Outcome|BBIBP bOPV Lot 1|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
11234388|NCT02434770|OG001|Outcome|BBIBP bOPV Lot 2|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
10954768|NCT00828139|OG003|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
10954769|NCT00828139|OG000|Outcome|Ziv-aflibercept + Topotecan|
10954770|NCT00828139|OG001|Outcome|Topotecan|
10954771|NCT00828139|EG000|Reported Event|Ziv-aflibercept + Topotecan|There are total 97 patients in this arm, but only 92 patients with measurable disease at baseline will be included in this analysis.
10954772|NCT00828139|EG001|Reported Event|Topotecan|There are total 92 patients in this arm, but only 87 patients with measurable disease at baseline will be included in this analysis.
10954773|NCT00828178|BG000|Baseline|Fish Oil|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
10954774|NCT00828178|BG001|Baseline|Placebo|corn starch
10954775|NCT00828178|BG002|Baseline|Total|Total of all reporting groups
10954776|NCT00828178|FG000|Participant Flow|Fish Oil|fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily
10954777|NCT00828178|FG001|Participant Flow|Placebo|Placebo (corn starch) once daily
10954778|NCT00828178|OG000|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
10954779|NCT00828178|OG001|Outcome|Placebo|Corn starch
10954780|NCT00828178|OG001|Outcome|Placebo|Placebo (cornstarch)
10954781|NCT00828178|OG001|Outcome|Placebo|Corn Starch
10954782|NCT00828178|EG000|Reported Event|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
10954783|NCT00828178|EG001|Reported Event|Placebo|Placebo (cornstarch)
10954784|NCT00828191|BG000|Baseline|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
10954785|NCT00828191|BG001|Baseline|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
10954786|NCT00828191|BG002|Baseline|Total|Total of all reporting groups
10954787|NCT00828191|FG000|Participant Flow|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
10954788|NCT00828191|FG001|Participant Flow|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
10954789|NCT00828191|OG000|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
10954790|NCT00828191|OG001|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
10954791|NCT00828191|EG000|Reported Event|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
10954792|NCT00828191|EG001|Reported Event|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
10954793|NCT00828204|BG000|Baseline|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
10954794|NCT00828204|BG001|Baseline|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
10954795|NCT00828204|BG002|Baseline|Total|Total of all reporting groups
10954796|NCT00828204|FG000|Participant Flow|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
10954797|NCT00828204|FG001|Participant Flow|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
10954798|NCT00828204|OG000|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
10954799|NCT00828204|OG000|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
10954800|NCT00828204|OG001|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
10954801|NCT00828204|EG000|Reported Event|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
11178710|NCT02049957|OG002|Outcome|Phase 1 (Part 2): Sapanisertib 3 mg + Exemestane|Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 8 cycles).
11178711|NCT02049957|OG003|Outcome|Phase 1 (Part 2): Sapanisertib 3 mg + Fulvestrant|Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle up to 14 cycles plus fulvestrant 500 mg, injection, IM, once on Day 1 of each cycle (Up to 14 cycles).
11178712|NCT02049957|OG004|Outcome|Phase 1 (Part 2): Sapanisertib 4 mg + Exemestane|Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 18 cycles).
11178713|NCT02049957|OG000|Outcome|Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Sensitive)|Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 14 cycles) in everolimus sensitive participants.
11178714|NCT02049957|OG001|Outcome|Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Sensitive)|Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 17 cycles) in everolimus sensitive participants.
10954802|NCT00828204|EG001|Reported Event|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
10954803|NCT00828295|BG000|Baseline|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
10954804|NCT00828295|BG001|Baseline|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
10954805|NCT00828295|BG002|Baseline|Total|Total of all reporting groups
10954806|NCT00828295|FG000|Participant Flow|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
10954807|NCT00828295|FG001|Participant Flow|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
10954808|NCT00828295|OG000|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
10954809|NCT00828295|OG001|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
10954810|NCT00828295|EG000|Reported Event|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
10954811|NCT00828295|EG001|Reported Event|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
10954812|NCT00828347|BG000|Baseline|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
10954813|NCT00828347|BG001|Baseline|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
10954814|NCT00828347|BG002|Baseline|Total|Total of all reporting groups
10954815|NCT00828347|FG000|Participant Flow|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
10954816|NCT00828347|FG001|Participant Flow|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
10954817|NCT00828347|OG000|Outcome|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
10954818|NCT00828347|OG001|Outcome|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
10954819|NCT00828347|EG000|Reported Event|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
10954820|NCT00828347|EG001|Reported Event|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
10954821|NCT00828412|BG000|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
10954822|NCT00828412|BG001|Baseline|Desonide Cream 0.05%|Desonide Cream 0.05%
10954823|NCT00828412|BG002|Baseline|Total|Total of all reporting groups
10954824|NCT00828412|FG000|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion topically twice daily
10954825|NCT00828412|FG001|Participant Flow|Desonide Cream 0.05%|Desonide Cream 0.05% topically twice daily
10954826|NCT00828412|OG000|Outcome|EpiCeram Skin Barrier Emulsion|Week 6 EpiCeram Skin Barrier Emulsion
10954827|NCT00828412|OG001|Outcome|Desonide Cream 0.05%|Week 6 Desonide Cream 0.05%
10954828|NCT00828412|EG000|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
10954829|NCT00828412|EG001|Reported Event|Desonide Cream 0.05%|Desonide Cream 0.05%
10954830|NCT00828451|BG000|Baseline|Preterm Infants for EGF Profiles|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
10954831|NCT00828451|FG000|Participant Flow|Preterm Infants for EGF Profiles|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
10954832|NCT00828451|OG000|Outcome|Preterm Infants for EGF Profiles|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
10954833|NCT00828451|EG000|Reported Event|Preterm Infants for EGF Profile|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
10954834|NCT00828464|BG000|Baseline|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
10954835|NCT00828464|FG000|Participant Flow|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
10954836|NCT00828464|OG000|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
10954837|NCT00828464|EG000|Reported Event|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
10963739|NCT00873912|FG000|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
10954838|NCT00828516|BG000|Baseline|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment
10954839|NCT00828516|FG000|Participant Flow|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment. Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by a further 6 treatments (Series 2) if participant wishes to continue treatment.
10954840|NCT00828516|OG000|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
10954841|NCT00828516|EG000|Reported Event|Usual Care Plus Traditional Acupuncture|
10954842|NCT00828542|BG000|Baseline|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery
10954843|NCT00828542|BG001|Baseline|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of DMPA (Contracept®, EMS Sigma Pharma, Hortolândia, Brazil)
10954844|NCT00828542|BG002|Baseline|Total|Total of all reporting groups
10954845|NCT00828542|FG000|Participant Flow|Etonogestrel Implant|Immediately after giving birth, women randomized to etonogestrel implant group had an Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is a long-acting reversible contraceptive method, compounded by 68mg of etonogestrel, 3years of duration.
10954846|NCT00828542|FG001|Participant Flow|Depot Medroxyprogesterone Acetate|Women randomized to depot medroxyprogesterone acetate group had at the 6th week postpartum, 150 mg of depot medroxyprogesterone acetate intramuscular (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil). A new injection was applied every 90 days if the patient wished to keep using the method.
11178715|NCT02049957|OG002|Outcome|Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Resistant)|Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles) in everolimus resistant participants.
11178716|NCT02049957|OG003|Outcome|Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Resistant)|Sapanisertib 4 mg, milled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 9 cycles) in everolimus resistant participants.
10954847|NCT00828542|OG000|Outcome|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery
10954848|NCT00828542|OG001|Outcome|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of depot medroxyprogesterone (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil)
10954849|NCT00828542|EG000|Reported Event|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery
10954850|NCT00828542|EG001|Reported Event|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of depot medroxyprogesterone (Contracept®, EMS Sigma Pharma, Hortolândia, Brazil)
10954851|NCT00828568|BG000|Baseline|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
10954852|NCT00828568|BG001|Baseline|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
10954853|NCT00828568|BG002|Baseline|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
10954854|NCT00828568|BG003|Baseline|Total|Total of all reporting groups
10954855|NCT00828568|FG000|Participant Flow|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
10954856|NCT00828568|FG001|Participant Flow|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
10954857|NCT00828568|FG002|Participant Flow|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
10954858|NCT00828568|OG000|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
10954859|NCT00828568|OG001|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
10954860|NCT00828568|OG002|Outcome|Vehicle|Patients receiving imiquimod vehicle for 16 weeks
10954861|NCT00828568|OG002|Outcome|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
10954862|NCT00828568|EG000|Reported Event|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
10954863|NCT00828568|EG001|Reported Event|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
10954864|NCT00828568|EG002|Reported Event|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
10954865|NCT00828672|BG000|Baseline|AXE (ARM 1)|"Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.~Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2~Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg~Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy~Radiotherapy: Total dose 45Gy"
10954866|NCT00828672|BG001|Baseline|AX (ARM 2)|"Bevacizumab and Capecitabine concurrently with radiotherapy~Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg~Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy~Radiotherapy: Total dose 45Gy"
10954867|NCT00828672|BG002|Baseline|Total|Total of all reporting groups
10954868|NCT00828672|FG000|Participant Flow|AXE (ARM 1)|"Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.~Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2~Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg~Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy~Radiotherapy: Total dose 45Gy"
10954869|NCT00828672|FG001|Participant Flow|AX (ARM 2)|"Bevacizumab and Capecitabine concurrently with radiotherapy~Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg~Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy~Radiotherapy: Total dose 45Gy"
11178717|NCT02049957|EG000|Reported Event|Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane|Sapanisertib 5 mg, unmilled active pharmaceutical ingredient (API) capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles).
11178718|NCT02049957|EG001|Reported Event|Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant|Sapanisertib 5 mg, unmilled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection, intramuscularly (IM), once on Day 1 of each cycle (Up to 57 cycles).
10954870|NCT00828672|OG000|Outcome|AXE (ARM 1)|"Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.~Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2~Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg~Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy~Radiotherapy: Total dose 45Gy"
10954871|NCT00828672|OG001|Outcome|AX (ARM 2)|"Bevacizumab and Capecitabine concurrently with radiotherapy~Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg~Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy~Radiotherapy: Total dose 45Gy"
10954872|NCT00828672|EG000|Reported Event|AXE (ARM 1)|"Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.~Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2~Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg~Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy~Radiotherapy: Total dose 45Gy"
10954873|NCT00828672|EG001|Reported Event|AX (ARM 2)|"Bevacizumab and Capecitabine concurrently with radiotherapy~Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg~Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy~Radiotherapy: Total dose 45Gy"
10954874|NCT00828711|BG000|Baseline|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954875|NCT00828711|BG001|Baseline|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954876|NCT00828711|BG002|Baseline|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954877|NCT00828711|BG003|Baseline|Total|Total of all reporting groups
10954878|NCT00828711|FG000|Participant Flow|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954879|NCT00828711|FG001|Participant Flow|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954880|NCT00828711|FG002|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954881|NCT00828711|OG000|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954882|NCT00828711|OG001|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954883|NCT00828711|OG002|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954884|NCT00828711|EG000|Reported Event|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954885|NCT00828711|EG001|Reported Event|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954886|NCT00828711|EG002|Reported Event|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
10954887|NCT00828750|BG000|Baseline|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
10954888|NCT00828750|FG000|Participant Flow|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
10954889|NCT00828750|OG000|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
10954890|NCT00828750|OG000|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
10954891|NCT00828750|EG000|Reported Event|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
10954892|NCT00828841|BG000|Baseline|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954893|NCT00828841|BG001|Baseline|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954894|NCT00828841|BG002|Baseline|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954895|NCT00828841|BG003|Baseline|Total|Total of all reporting groups
10954896|NCT00828841|FG000|Participant Flow|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954897|NCT00828841|FG001|Participant Flow|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
11178719|NCT02049957|EG002|Reported Event|Phase 1 (Part 2): Sapanisertib 3 mg + Exemestane|Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 8 cycles).
11178720|NCT02049957|EG003|Reported Event|Phase 1 (Part 2): Sapanisertib 3 mg + Fulvestrant|Sapanisertib 3 mg, milled API capsule, once daily in a 28-day cycle up to 14 cycles plus fulvestrant 500 mg, injection, IM, once on Day 1 of each cycle (Up to 14 cycles).
11178721|NCT02049957|EG004|Reported Event|Phase 1 (Part 2): Sapanisertib 4 mg + Exemestane|Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 18 cycles).
10954898|NCT00828841|FG002|Participant Flow|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954899|NCT00828841|OG000|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954900|NCT00828841|OG001|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954901|NCT00828841|OG002|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954902|NCT00828841|OG000|Outcome|Squamous Cell Histology|Subjects who were identified as having squamous cell histology, prior to randomization to a treatment arm.
10954903|NCT00828841|OG001|Outcome|Non-squamous Cell Histology|Subjects who were identified as having non-squamous cell histology, prior to randomization to a treatment arm.
10954904|NCT00828841|EG000|Reported Event|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954905|NCT00828841|EG001|Reported Event|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10963740|NCT00873912|FG001|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
11234389|NCT02434770|OG002|Outcome|BioFarma bOPV|Infants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
11234390|NCT02434770|OG002|Outcome|BBIBP bOPV Lot 1 + Lot 2|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1 or Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
11234391|NCT02434770|OG003|Outcome|BioFarma bOPV|Infants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
11234392|NCT02434770|EG000|Reported Event|BBIBP bOPV Lot 1|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
10954906|NCT00828841|EG002|Reported Event|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
10954907|NCT00828945|BG000|Baseline|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
10954908|NCT00828945|FG000|Participant Flow|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
10954909|NCT00828945|OG000|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
10954910|NCT00828945|EG000|Reported Event|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
10954911|NCT00828984|BG000|Baseline|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954912|NCT00828984|BG001|Baseline|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954913|NCT00828984|BG002|Baseline|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954914|NCT00828984|BG003|Baseline|Total|Total of all reporting groups
10954915|NCT00828984|FG000|Participant Flow|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954916|NCT00828984|FG001|Participant Flow|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954917|NCT00828984|FG002|Participant Flow|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954918|NCT00828984|OG000|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954919|NCT00828984|OG001|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954920|NCT00828984|OG002|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954921|NCT00828984|EG000|Reported Event|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954922|NCT00828984|EG001|Reported Event|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954923|NCT00828984|EG002|Reported Event|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10954924|NCT00829010|BG000|Baseline|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10963741|NCT00873912|OG000|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
10963742|NCT00873912|OG001|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
10954925|NCT00829010|BG001|Baseline|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954926|NCT00829010|BG002|Baseline|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954927|NCT00829010|BG003|Baseline|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954928|NCT00829010|BG004|Baseline|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954929|NCT00829010|BG005|Baseline|Total|Total of all reporting groups
10954930|NCT00829010|FG000|Participant Flow|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954931|NCT00829010|FG001|Participant Flow|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954932|NCT00829010|FG002|Participant Flow|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
11178722|NCT02049957|EG005|Reported Event|Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Sensitive)|Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 14 cycles) in everolimus sensitive participants.
10954933|NCT00829010|FG003|Participant Flow|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954934|NCT00829010|FG004|Participant Flow|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954935|NCT00829010|OG000|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954936|NCT00829010|OG001|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954937|NCT00829010|OG002|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954938|NCT00829010|OG003|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954939|NCT00829010|OG004|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10963743|NCT00873912|EG000|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
10954940|NCT00829010|EG000|Reported Event|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954941|NCT00829010|EG001|Reported Event|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954942|NCT00829010|EG002|Reported Event|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954943|NCT00829010|EG003|Reported Event|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954944|NCT00829010|EG004|Reported Event|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
10954945|NCT00829036|BG000|Baseline|Baseline Wayfinding Performance|An Orientation and Mobility specialist teaches subjects (1) how to find each of 4 specific locations in an open space from a random starting location, and (2) how to navigate hallways from a known starting location to find each of 8 specific locations in the hallways of the Atlanta VA Medical Center. Subjects are then (1) brought to a random start point in the open space and asked to walk to the same 4 specific locations they were taught to find and (2) brought to a known starting point in the hallways of the VA Medical Center and asked to walk to the same 8 specific locations they were taught to find.
10954946|NCT00829036|FG000|Participant Flow|Prototype vs. Baseline|"Prototype:~Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
10963744|NCT00873912|EG001|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
10954947|NCT00829036|OG000|Outcome|Prototype vs. Baseline|"Prototype:~Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
10954948|NCT00829036|EG000|Reported Event|Wayfinding: Prototype vs. Baseline|"Prototype:~Subjects are trained to use the prototype to walk to selected destinations (1) in open spaces and (2) through hallways. Then, over 12 trials, subjects are asked to use the prototype to walk to a different unknown location in each trial. Half the locations are in open spaces and half in hallways. Performance time is measured.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subjects how to find (walk to) 12 specific locations, 6 in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations. Performance time is measured."
10954949|NCT00829049|BG000|Baseline|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
10954950|NCT00829049|BG001|Baseline|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
10954951|NCT00829049|BG002|Baseline|Total|Total of all reporting groups
10954952|NCT00829049|FG000|Participant Flow|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
10954953|NCT00829049|FG001|Participant Flow|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
11178723|NCT02049957|EG006|Reported Event|Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Resistant)|Sapanisertib 4 mg, milled API capsule, once daily, in a 28-day cycle plus exemestane 25 mg, tablets, once daily in a 28-day cycle (Up to 12 cycles) in everolimus resistant participants.
11178724|NCT02049957|EG007|Reported Event|Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Sensitive)|Sapanisertib 4 mg, milled API capsule once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 17 cycles) in everolimus sensitive participants.
10954954|NCT00829049|OG000|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
10954955|NCT00829049|OG001|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
10954956|NCT00829049|EG000|Reported Event|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
10954957|NCT00829049|EG001|Reported Event|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
10954958|NCT00829166|BG000|Baseline|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
10954959|NCT00829166|BG001|Baseline|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
10954960|NCT00829166|BG002|Baseline|Total|Total of all reporting groups
10954961|NCT00829166|FG000|Participant Flow|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
10954962|NCT00829166|FG001|Participant Flow|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
10954963|NCT00829166|OG000|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
10954964|NCT00829166|OG001|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
10954965|NCT00829166|EG000|Reported Event|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
10954966|NCT00829166|EG001|Reported Event|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
10954967|NCT00829166|EG002|Reported Event|Lapatinib + Capecitabine/ Trastuzumab Emtansine|"Participants of Lapatinib + Capecitabine arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis."
10954968|NCT00829179|BG000|Baseline|RhuMab-E25|
11178725|NCT02049957|EG008|Reported Event|Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Resistant)|Sapanisertib 4 mg, milled API capsule, once daily in a 28-day cycle plus fulvestrant 500 mg, injection IM, once on Day 1 of each cycle (Up to 9 cycles) in everolimus resistant participants.
10954969|NCT00829179|FG000|Participant Flow|RhuMab-E25|"Subjects with mild asthma received three doses of study drug subcutaneous injections at one month intervals. Dosing range was 150mg-375mg which was based on baseline IGE and subject body weight.~Subjects with a baseline Ige above 30 and up to 100 with a body weight between 30 and 150kg would receive a study drug dose of 150 mg. Subjects with an IGE 100-200 and body weight 30 - 150 kg would receive a dose of 225 mg. And up to subjects with an IGE of 600-700 only body weight of 30 - 60 would be included with a dose of 375 mg."
10954970|NCT00829179|OG000|Outcome|RhuMab-E25|
10954971|NCT00829179|EG000|Reported Event|RhuMab-E25|
10954972|NCT00829244|BG000|Baseline|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
10954973|NCT00829244|BG001|Baseline|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
10954974|NCT00829244|BG002|Baseline|Total|Total of all reporting groups
10954975|NCT00829244|FG000|Participant Flow|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
10954976|NCT00829244|FG001|Participant Flow|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
10954977|NCT00829244|OG000|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
10954978|NCT00829244|OG001|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
10954979|NCT00829244|EG000|Reported Event|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
10954980|NCT00829244|EG001|Reported Event|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
11192331|NCT02138227|OG004|Outcome|Mid-Level Post-Intervention Requester Comfort (Autonomous)|Mean level of comfort mid-level staff self-reported post-intervention in the autonomous arm. Mid-level participants are defined has having more 13 to 36 months of experience.
10954981|NCT00829283|BG000|Baseline|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
10954982|NCT00829283|BG001|Baseline|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
10954983|NCT00829283|BG002|Baseline|Total|Total of all reporting groups
10954984|NCT00829283|FG000|Participant Flow|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
10954985|NCT00829283|FG001|Participant Flow|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
10954986|NCT00829283|OG000|Outcome|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
10954987|NCT00829283|OG001|Outcome|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
10954988|NCT00829283|EG000|Reported Event|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
10954989|NCT00829283|EG001|Reported Event|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
10954990|NCT00829296|BG000|Baseline|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
10954991|NCT00829296|BG001|Baseline|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
10954992|NCT00829296|BG002|Baseline|Total|Total of all reporting groups
10954993|NCT00829296|FG000|Participant Flow|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
10954994|NCT00829296|FG001|Participant Flow|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
10954995|NCT00829296|OG000|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
10954996|NCT00829296|OG001|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
10954997|NCT00829296|EG000|Reported Event|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
10954998|NCT00829296|EG001|Reported Event|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
10954999|NCT00829387|BG000|Baseline|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
10955000|NCT00829387|BG001|Baseline|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
10955001|NCT00829387|BG002|Baseline|Total|Total of all reporting groups
10955002|NCT00829387|FG000|Participant Flow|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
10955003|NCT00829387|FG001|Participant Flow|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
10955004|NCT00829387|OG000|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
10955005|NCT00829387|OG001|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
10955006|NCT00829387|EG000|Reported Event|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
10955007|NCT00829387|EG001|Reported Event|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
10955008|NCT00829413|BG000|Baseline|ITD Population|All patients who were enrolled in the efficacy phase, received SonoVue, had a definite final diagnosis from truth standard and unenhanced and SonoVue-enhanced ultrasonography available
10955009|NCT00829413|FG000|Participant Flow|Safety Population|"Interventions included SonoVue administration, unenhanced (UE-US) and SonoVue-enhanced ultrasound (CE-US) and definitive truth standard diagnosis.~Any patient who received SonoVue is included in the Safety Population. Thirteen patients who started had No study drug administered and are not included in the Safety Population.~Among patients in the Safety Population, 67 training phase patients were excluded from efficacy analysis. Completed patients included efficacy phase patients who underwent unenhanced and SonoVue-enhanced ultrasound and had definite truth standard diagnosis available."
10955010|NCT00829413|OG000|Outcome|Offsite Reader 1 UE-US|Offsite Reader 1 UE-US assessment
10955011|NCT00829413|OG001|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
10955012|NCT00829413|OG002|Outcome|Offsite Reader 2 UE-US|Offsite Reader 2 UE-US assessment
10955013|NCT00829413|OG003|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
10955014|NCT00829413|OG004|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
10955015|NCT00829413|OG005|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
10955016|NCT00829413|OG000|Outcome|UE-US|UE-US Inter-reader agreement
10955017|NCT00829413|OG001|Outcome|CE-US|CE-US Inter-reader agreement
10955018|NCT00829413|EG000|Reported Event|Safety Population|"Interventions included SonoVue administration, unenhanced and SonoVue-enhanced ultrasound and definitive truth standard diagnosis.~Any patient who received SonoVue, training or efficacy phase, regardless of availability of ultrasonography or truth standard, is included in the Safety Population."
10955019|NCT00829439|BG000|Baseline|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
10955020|NCT00829439|FG000|Participant Flow|Levodopa/Carbidopa 2 mg/kg/Day|Levodopa at 2 mg/kg/day in 3 divided doses
10955021|NCT00829439|FG001|Participant Flow|Levodopa / Carbidopa 5 mg/kg/Day|Levodopa 5 mg/kg/day in 3 divided doses
10955022|NCT00829439|FG002|Participant Flow|Levodopa / Carbidopa 10 mg/kg/Day|Levodopa 10 mg/kg/day in 3 divided doses
10955023|NCT00829439|FG003|Participant Flow|Levodopa / Carbidopa 15 mg/kg/Day|Levodopa / Carbidopa 15 mg/kg/day in 3 divided doses
10955024|NCT00829439|OG000|Outcome|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
10955025|NCT00829439|EG000|Reported Event|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
10955026|NCT00829621|BG000|Baseline|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
10955027|NCT00829621|BG001|Baseline|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
10955028|NCT00829621|BG002|Baseline|Total|Total of all reporting groups
10955029|NCT00829621|FG000|Participant Flow|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
10955030|NCT00829621|FG001|Participant Flow|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
10955031|NCT00829621|OG000|Outcome|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
10955032|NCT00829621|OG001|Outcome|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
10955033|NCT00829621|EG000|Reported Event|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
10955034|NCT00829621|EG001|Reported Event|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
10955035|NCT00829738|BG000|Baseline|Pantoprazole|All patients enrolled
10955036|NCT00829738|FG000|Participant Flow|Pantoprazole|All patients enrolled
10955037|NCT00829738|OG000|Outcome|Pantoprazole|All patients with valid values at first and last visit
10955038|NCT00829738|OG000|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
10955039|NCT00829738|EG000|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
10955040|NCT00829829|BG000|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
10955041|NCT00829829|BG001|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
10955042|NCT00829829|BG002|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10955043|NCT00829829|BG003|Baseline|Total|Total of all reporting groups
10955044|NCT00829829|FG000|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
10955045|NCT00829829|FG001|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
10955046|NCT00829829|FG002|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10955047|NCT00829829|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
10955048|NCT00829829|OG001|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
10955049|NCT00829829|OG002|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10955050|NCT00829829|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
10955051|NCT00829829|EG000|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
10955052|NCT00829829|EG001|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
10955053|NCT00829829|EG002|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10955054|NCT00829933|BG000|Baseline|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
10955055|NCT00829933|BG001|Baseline|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
10955056|NCT00829933|BG002|Baseline|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
10955057|NCT00829933|BG003|Baseline|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
10955058|NCT00829933|BG004|Baseline|Total|Total of all reporting groups
10955059|NCT00829933|FG000|Participant Flow|DU-176b Low Dose 30mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
10955060|NCT00829933|FG001|Participant Flow|DU-176b Intermediate Dose 45mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
10955061|NCT00829933|FG002|Participant Flow|DU-176b High Dose 60mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
10955062|NCT00829933|FG003|Participant Flow|Warfarin|"Warfarin potassium tablets:~Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose"
10955063|NCT00829933|OG000|Outcome|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
10955064|NCT00829933|OG001|Outcome|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
10955065|NCT00829933|OG002|Outcome|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
10955066|NCT00829933|OG003|Outcome|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
10955067|NCT00829933|EG000|Reported Event|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
10955068|NCT00829933|EG001|Reported Event|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
10955069|NCT00829933|EG002|Reported Event|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
10955070|NCT00829933|EG003|Reported Event|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
10955071|NCT00829985|BG000|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
10955072|NCT00829985|BG001|Baseline|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
10955073|NCT00829985|BG002|Baseline|Total|Total of all reporting groups
10955074|NCT00829985|FG000|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
10955075|NCT00829985|FG001|Participant Flow|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
10955076|NCT00829985|OG000|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
10955077|NCT00829985|OG001|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
10955078|NCT00829985|EG000|Reported Event|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
10955079|NCT00829985|EG001|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
10955080|NCT00830037|BG000|Baseline|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
10955081|NCT00830037|BG001|Baseline|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
10955082|NCT00830037|BG002|Baseline|Total|Total of all reporting groups
10955083|NCT00830037|FG000|Participant Flow|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
10955084|NCT00830037|FG001|Participant Flow|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
10955085|NCT00830037|OG000|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
10955086|NCT00830037|OG001|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
10955087|NCT00830037|EG000|Reported Event|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
10955088|NCT00830037|EG001|Reported Event|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
10955089|NCT00830063|BG000|Baseline|Placebo|Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
10955090|NCT00830063|BG001|Baseline|Tanezumab 5 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955091|NCT00830063|BG002|Baseline|Tanezumab 10 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955092|NCT00830063|BG003|Baseline|Naproxen + Placebo|Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
10955093|NCT00830063|BG004|Baseline|Total|Total of all reporting groups
10955094|NCT00830063|FG000|Participant Flow|Placebo|Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
10955095|NCT00830063|FG001|Participant Flow|Tanezumab 5 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955096|NCT00830063|FG002|Participant Flow|Tanezumab 10 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955097|NCT00830063|FG003|Participant Flow|Naproxen + Placebo|Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
10955098|NCT00830063|OG000|Outcome|Placebo|Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
10955099|NCT00830063|OG001|Outcome|Tanezumab 5 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955100|NCT00830063|OG002|Outcome|Tanezumab 10 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955101|NCT00830063|OG003|Outcome|Naproxen + Placebo|Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
10955102|NCT00830063|OG000|Outcome|Tanezumab 5 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955103|NCT00830063|OG001|Outcome|Tanezumab 10 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955104|NCT00830063|EG000|Reported Event|Placebo|Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.
10955105|NCT00830063|EG001|Reported Event|Tanezumab 5 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
11192332|NCT02138227|OG005|Outcome|Mid-Level Post-Intervention Requester Comfort (Assisted)|Mean level of comfort mid-level staff self-reported post-intervention in the assisted arm. Mid-level participants are defined has having more 13 to 36 months of experience.
10955106|NCT00830063|EG002|Reported Event|Tanezumab 10 mg + Placebo|Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
10955107|NCT00830063|EG003|Reported Event|Naproxen + Placebo|Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
10955108|NCT00830076|BG000|Baseline|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
10955109|NCT00830076|FG000|Participant Flow|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
10955110|NCT00830076|OG000|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
10955111|NCT00830076|EG000|Reported Event|Sitagliptin + Placebo Metformin|Participants received sitagliptin + placebo metformin for 2 days.
10955112|NCT00830076|EG001|Reported Event|Metformin + Placebo Sitagliptin|Participants received metformin + placebo sitagliptin for 2 days.
10955113|NCT00830076|EG002|Reported Event|Sitagliptin + Metformin|Participants received co-administration of sitagliptin + metformin for 2 days.
10955114|NCT00830076|EG003|Reported Event|Placebo Sitagliptin + Placebo Metformin|Participants received placebo sitagliptin + placebo metformin for 2 days.
10955115|NCT00830115|BG000|Baseline|Pantoprazole|All patients enrolled
10955116|NCT00830115|FG000|Participant Flow|Pantoprazole|All patients enrolled
10955117|NCT00830115|OG000|Outcome|Pantoprazole|All patients with valid value at least at day 0
10955118|NCT00830115|OG000|Outcome|Pantoprazole|All patients with valid values at first and last visit
10955119|NCT00830115|OG000|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
10955120|NCT00830115|EG000|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
10955121|NCT00830128|BG000|Baseline|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
10955122|NCT00830128|FG000|Participant Flow|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
10955123|NCT00830128|OG000|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
10955124|NCT00830128|EG000|Reported Event|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
10955125|NCT00830167|BG000|Baseline|Placebo|Placebo was administered twice a day for 15 weeks.
10955126|NCT00830167|BG001|Baseline|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
10955127|NCT00830167|BG002|Baseline|Total|Total of all reporting groups
10955128|NCT00830167|FG000|Participant Flow|Placebo|Placebo was administered twice a day for 15 weeks.
10955129|NCT00830167|FG001|Participant Flow|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
10955130|NCT00830167|OG000|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
10955131|NCT00830167|OG001|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
10955132|NCT00830167|EG000|Reported Event|Placebo|Placebo was administered twice a day for 15 weeks.
10955133|NCT00830167|EG001|Reported Event|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
10955134|NCT00830180|BG000|Baseline|Tanezumab 10 mg (A4091029)|Participants received a single intravenous (IV) infusion of tanezumab 10 milligram (mg) administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). For participants in Poland entering the Extended-use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.
10955135|NCT00830180|FG000|Participant Flow|Tanezumab 10 mg (A4091029)|Participants received a single intravenous (IV) infusion of tanezumab 10 milligram (mg) administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). For participants in Poland entering the Extended-use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.
11192333|NCT02138227|OG006|Outcome|Senior Pre-Intevention Aggregate Requester Comfort|Mean level of comfort senior staff self-reported pre-intervention. Senior participants are defined has having more than 36 months of experience.
10955136|NCT00830180|OG000|Outcome|Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)|Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 mg administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). Participants in Poland entering the Extended-Use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.
10955137|NCT00830180|OG001|Outcome|Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)|Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 mg administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). Participants in Poland entering the Extended-Use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.
10955138|NCT00830180|OG000|Outcome|Tanezumab 10 mg (A4091029)|Participants received a single intravenous (IV) infusion of tanezumab 10 milligram (mg) administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). For participants in Poland entering the Extended-use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.
10955139|NCT00830180|EG000|Reported Event|Tanezumab 10 mg (A4091029)|Participants received a single intravenous (IV) infusion of tanezumab 10 milligram (mg) administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). For participants in Poland entering the Extended-use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.
10955140|NCT00830232|BG000|Baseline|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
10955141|NCT00830232|BG001|Baseline|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
10955142|NCT00830232|BG002|Baseline|Total|Total of all reporting groups
10955143|NCT00830232|FG000|Participant Flow|Closed-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this group was the Xact closed-cell stent. This type of device is a rigid device with a dense composition between the nitinol rings.~Carotid stenting was used on standard fashion using filters as embolic protection device."
10955144|NCT00830232|FG001|Participant Flow|Open-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent.~Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device."
10955145|NCT00830232|OG000|Outcome|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
10955146|NCT00830232|OG001|Outcome|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
10955147|NCT00830232|EG000|Reported Event|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
10955148|NCT00830232|EG001|Reported Event|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
10955149|NCT00830284|BG000|Baseline|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
11178726|NCT02050048|BG000|Baseline|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
11178727|NCT02050048|BG001|Baseline|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive intravenous Lactated Ringer's solution at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
10955150|NCT00830284|FG000|Participant Flow|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
10955151|NCT00830284|OG000|Outcome|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
10955152|NCT00830284|EG000|Reported Event|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
10955153|NCT00830310|BG000|Baseline|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
10955154|NCT00830310|FG000|Participant Flow|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
11178728|NCT02050048|BG002|Baseline|Total|Total of all reporting groups
10955155|NCT00830310|OG000|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
10955156|NCT00830310|EG000|Reported Event|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
10955157|NCT00830362|BG000|Baseline|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
10955158|NCT00830362|BG001|Baseline|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
10955159|NCT00830362|BG002|Baseline|Total|Total of all reporting groups
10955160|NCT00830362|FG000|Participant Flow|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects whose data we analyzed upon study completion who received propranolol were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
10955161|NCT00830362|FG001|Participant Flow|Placebo|Placebo : administered once. The subjects whose data we analyzed upon study completion who received placebo were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
10955162|NCT00830362|OG000|Outcome|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
10955163|NCT00830362|OG001|Outcome|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
10955164|NCT00830362|EG000|Reported Event|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
10955165|NCT00830362|EG001|Reported Event|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
10955166|NCT00830375|BG000|Baseline|Memantine|10-30mg tablets of memantine taken once daily by mouth
10955167|NCT00830375|FG000|Participant Flow|Memantine|10-30mg tablets of memantine taken once daily by mouth
10955168|NCT00830375|OG000|Outcome|Memantine|10-30mg tablets of memantine taken once daily by mouth
10955169|NCT00830375|EG000|Reported Event|Memantine|10-30mg tablets of memantine taken once daily by mouth
10955170|NCT00830388|BG000|Baseline|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
10955171|NCT00830388|FG000|Participant Flow|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
10955172|NCT00830388|OG000|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
10955173|NCT00830388|EG000|Reported Event|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
10955174|NCT00830440|BG000|Baseline|EndoBarrier and Diet/Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
10955175|NCT00830440|BG001|Baseline|Control: (Diet and Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
10955176|NCT00830440|BG002|Baseline|Total|Total of all reporting groups
10955177|NCT00830440|FG000|Participant Flow|EndoBarrier Device|"EndoBarrier + Diet + Lifestyle counseling 12 Week implant duration~EndoBarrier: Monthly visits"
10955178|NCT00830440|FG001|Participant Flow|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
10955179|NCT00830440|OG000|Outcome|EndoBarrier/Diet and Lifestyle Counseling/12 Weeks|12 week implantation period
10955180|NCT00830440|OG001|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
10955181|NCT00830440|OG000|Outcome|EndoBarrier and Diet and Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
10955182|NCT00830440|EG000|Reported Event|EndoBarrier and Diet and Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
10955183|NCT00830440|EG001|Reported Event|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
10955184|NCT00830518|BG000|Baseline|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
10955185|NCT00830518|BG001|Baseline|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
10955186|NCT00830518|BG002|Baseline|Total|Total of all reporting groups
10955187|NCT00830518|FG000|Participant Flow|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
10955188|NCT00830518|FG001|Participant Flow|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
10955189|NCT00830518|OG000|Outcome|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
10955190|NCT00830518|OG001|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
10955191|NCT00830518|OG000|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
10955192|NCT00830518|EG000|Reported Event|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
10955193|NCT00830518|EG001|Reported Event|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
10955194|NCT00830596|BG000|Baseline|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
10955195|NCT00830596|BG001|Baseline|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
10955196|NCT00830596|BG002|Baseline|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
10955197|NCT00830596|BG003|Baseline|Total|Total of all reporting groups
10955198|NCT00830596|FG000|Participant Flow|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
10955199|NCT00830596|FG001|Participant Flow|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
10955200|NCT00830596|FG002|Participant Flow|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
10955201|NCT00830596|OG000|Outcome|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
10955202|NCT00830596|OG001|Outcome|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
10955203|NCT00830596|OG002|Outcome|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
10955204|NCT00830596|EG000|Reported Event|HVLA-SM*|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
10955205|NCT00830596|EG001|Reported Event|LVVA-SM*|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
10955206|NCT00830596|EG002|Reported Event|Sham Intervention*|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
10955207|NCT00830765|BG000|Baseline|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
10955208|NCT00830765|BG001|Baseline|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
10955209|NCT00830765|BG002|Baseline|Total|Total of all reporting groups
10955210|NCT00830765|FG000|Participant Flow|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
10955211|NCT00830765|FG001|Participant Flow|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
10955212|NCT00830765|OG000|Outcome|Progesterone Group|Progesterone injection was compared to placebo injection on a weekly basis.
10955213|NCT00830765|OG001|Outcome|Placebo Group|Progesterone injection was compared to placebo injection on a weekly basis.
10955214|NCT00830765|EG000|Reported Event|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
10955215|NCT00830765|EG001|Reported Event|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
10955216|NCT00830791|BG000|Baseline|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
10955217|NCT00830791|BG001|Baseline|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
10955218|NCT00830791|BG002|Baseline|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
10955219|NCT00830791|BG003|Baseline|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
11178729|NCT02050048|FG000|Participant Flow|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
11178730|NCT02050048|FG001|Participant Flow|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
10955220|NCT00830791|BG004|Baseline|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
10955221|NCT00830791|BG005|Baseline|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
10955222|NCT00830791|BG006|Baseline|Total|Total of all reporting groups
10955223|NCT00830791|FG000|Participant Flow|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
10955224|NCT00830791|FG001|Participant Flow|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
10955225|NCT00830791|FG002|Participant Flow|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
10955226|NCT00830791|FG003|Participant Flow|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
11178731|NCT02050048|OG000|Outcome|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
11178732|NCT02050048|OG001|Outcome|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period.
10955227|NCT00830791|FG004|Participant Flow|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
10955228|NCT00830791|FG005|Participant Flow|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
10955229|NCT00830791|OG000|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
10955230|NCT00830791|OG001|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
10955231|NCT00830791|OG000|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
10955232|NCT00830791|OG001|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
10955233|NCT00830791|OG001|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose of 10 mg x 2.
10955234|NCT00830791|OG001|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
10955235|NCT00830791|OG001|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
10955236|NCT00830791|OG001|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg.
10955237|NCT00830791|EG000|Reported Event|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
10955238|NCT00830791|EG001|Reported Event|MK-0941 20 mg and Mild Renal Insufficiency|MK-0941 was administered as a single oral dose to participants with mild renal insufficiency.
10955239|NCT00830791|EG002|Reported Event|MK-0941 20 mg and Moderate Renal Insufficiency|MK-0941 was administered as a single oral dose of 20 mg to participants with moderate renal insufficiency.
10955240|NCT00830804|BG000|Baseline|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
10955241|NCT00830804|FG000|Participant Flow|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
10955242|NCT00830804|OG000|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
10955243|NCT00830804|OG000|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
10955244|NCT00830804|EG000|Reported Event|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
10955245|NCT00830869|BG000|Baseline|Part 1: Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955246|NCT00830869|BG001|Baseline|Part 1: Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955247|NCT00830869|BG002|Baseline|Part 1: Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955248|NCT00830869|BG003|Baseline|Part 1: Ixazomib 1 mg/m^2|Ixazomib (MLN9708) 1 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955249|NCT00830869|BG004|Baseline|Part 1: Ixazomib 1.33 mg/m^2|Ixazomib (MLN9708) 1.33 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955250|NCT00830869|BG005|Baseline|Part 1: Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955251|NCT00830869|BG006|Baseline|Part 1: Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955252|NCT00830869|BG007|Baseline|Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.
10955253|NCT00830869|BG008|Baseline|Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H&N during Part 2 of the study.
10955254|NCT00830869|BG009|Baseline|Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.
10955255|NCT00830869|BG010|Baseline|Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.
10955256|NCT00830869|BG011|Baseline|Part 2: Ixazomib 1.76 mg/m^2-TPEC|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.
10955257|NCT00830869|BG012|Baseline|Total|Total of all reporting groups
10955258|NCT00830869|FG000|Participant Flow|Part 1: Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955259|NCT00830869|FG001|Participant Flow|Part 1: Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955260|NCT00830869|FG002|Participant Flow|Part 1: Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955261|NCT00830869|FG003|Participant Flow|Part 1: Ixazomib 1 mg/m^2|Ixazomib (MLN9708) 1 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955262|NCT00830869|FG004|Participant Flow|Part 1: Ixazomib 1.33 mg/m^2|Ixazomib (MLN9708) 1.33 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955263|NCT00830869|FG005|Participant Flow|Part 1: Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
11192334|NCT02138227|OG007|Outcome|Senior Post-Intervention Requester Comfort (Autonomous)|Mean level of comfort senior staff self-reported post-intervention in the autonomous arm. Senior participants are defined has having more than 36 months of experience.
10955264|NCT00830869|FG006|Participant Flow|Part 1: Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955265|NCT00830869|FG007|Participant Flow|Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.
10955266|NCT00830869|FG008|Participant Flow|Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H&N during Part 2 of the study.
10955267|NCT00830869|FG009|Participant Flow|Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.
10955268|NCT00830869|FG010|Participant Flow|Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.
10955269|NCT00830869|FG011|Participant Flow|Part 2: Ixazomib 1.76 mg/m^2-TPEC|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.
10955270|NCT00830869|OG000|Outcome|Part 1: Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955271|NCT00830869|OG001|Outcome|Part 1: Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955272|NCT00830869|OG002|Outcome|Part 1: Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955273|NCT00830869|OG003|Outcome|Part 1: Ixazomib 1 mg/m^2|Ixazomib (MLN9708) 1 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955274|NCT00830869|OG004|Outcome|Part 1: Ixazomib 1.33 mg/m^2|Ixazomib (MLN9708) 1.33 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
11234393|NCT02434770|EG001|Reported Event|BBIBP bOPV Lot 2|Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
10955275|NCT00830869|OG005|Outcome|Part 1: Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955276|NCT00830869|OG006|Outcome|Part 1: Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955277|NCT00830869|OG007|Outcome|Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.
10955278|NCT00830869|OG008|Outcome|Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H&N during Part 2 of the study.
10955279|NCT00830869|OG009|Outcome|Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.
10955280|NCT00830869|OG010|Outcome|Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.
10955281|NCT00830869|OG011|Outcome|Part 2: Ixazomib 1.76 mg/m^2-TPEC|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.
10955282|NCT00830869|OG000|Outcome|Part 2: Ixazomib 1.76 mg/m^2-TPEC|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.
10955283|NCT00830869|EG000|Reported Event|Part 1: Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955284|NCT00830869|EG001|Reported Event|Part 1: Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955285|NCT00830869|EG002|Reported Event|Part 1: Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955286|NCT00830869|EG003|Reported Event|Part 1: Ixazomib 1 mg/m^2|Ixazomib (MLN9708) 1 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955287|NCT00830869|EG004|Reported Event|Part 1: Ixazomib 1.33 mg/m^2|Ixazomib (MLN9708) 1.33 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955288|NCT00830869|EG005|Reported Event|Part 1: Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955289|NCT00830869|EG006|Reported Event|Part 1: Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.
10955290|NCT00830869|EG007|Reported Event|Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.
10955291|NCT00830869|EG008|Reported Event|Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H&N during Part 2 of the study.
10955292|NCT00830869|EG009|Reported Event|Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.
10955293|NCT00830869|EG010|Reported Event|Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.
10955294|NCT00830869|EG011|Reported Event|Part 2: Ixazomib 1.76 mg/m^2-TPEC|Ixazomib (MLN9708) 1.76 mg/m^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.
10955295|NCT00830947|BG000|Baseline|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
10955296|NCT00830947|BG001|Baseline|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
10955297|NCT00830947|BG002|Baseline|Total|Total of all reporting groups
10955298|NCT00830947|FG000|Participant Flow|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
10955299|NCT00830947|FG001|Participant Flow|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
10955300|NCT00830947|OG000|Outcome|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
10955301|NCT00830947|OG001|Outcome|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
10955302|NCT00830947|EG000|Reported Event|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
10955303|NCT00830947|EG001|Reported Event|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
10955304|NCT00830960|BG000|Baseline|Prasugrel 60/10 Primary|"Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)~Reporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug."
10955305|NCT00830960|BG001|Baseline|Prasugrel 30/7.5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955306|NCT00830960|BG002|Baseline|Prasugrel 30/5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955307|NCT00830960|BG003|Baseline|Clopidogrel 300/75 Primary|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955308|NCT00830960|BG004|Baseline|Prasugrel 30/5 Low Weight/Elderly|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
10955309|NCT00830960|BG005|Baseline|Clopidogrel 300/75 Low Weight/Elderly|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
10955310|NCT00830960|BG006|Baseline|Total|Total of all reporting groups
10955311|NCT00830960|FG000|Participant Flow|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955312|NCT00830960|FG001|Participant Flow|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955313|NCT00830960|FG002|Participant Flow|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955314|NCT00830960|FG003|Participant Flow|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955315|NCT00830960|FG004|Participant Flow|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
10955316|NCT00830960|FG005|Participant Flow|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
10955317|NCT00830960|OG000|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
10955318|NCT00830960|OG001|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
10955319|NCT00830960|OG002|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
10955320|NCT00830960|OG003|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
10955321|NCT00830960|OG004|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
10955322|NCT00830960|OG000|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955323|NCT00830960|OG001|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955324|NCT00830960|OG002|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955325|NCT00830960|OG003|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955326|NCT00830960|OG004|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
10955327|NCT00830960|OG005|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
10955328|NCT00830960|OG000|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 60-mg LD.
10955329|NCT00830960|OG001|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 30-mg LD(including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
10955330|NCT00830960|OG002|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were treated with a clopidogrel 300-mg LD.
11178733|NCT02050048|EG000|Reported Event|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
10955331|NCT00830960|OG003|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a prasugrel 30-mg LD.
10955332|NCT00830960|OG004|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a clopidogrel 300-mg LD.
10955333|NCT00830960|OG000|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955334|NCT00830960|OG003|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955335|NCT00830960|OG004|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
10955336|NCT00830960|OG005|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
10955337|NCT00830960|OG000|Outcome|Prasugrel 60/10 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955338|NCT00830960|OG001|Outcome|Prasugrel 30/7.5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955339|NCT00830960|OG002|Outcome|Prasugrel 30/5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
10955340|NCT00830960|OG003|Outcome|Clopidogrel 300/75 Primary|Population includes participants in primary cohort randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort participant weight ≥60 kg and age <75 years)
10955341|NCT00830960|OG000|Outcome|Prasugrel 60/10 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary Cohort.
10955342|NCT00830960|OG001|Outcome|Prasugrel 30/7.5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
10955343|NCT00830960|OG002|Outcome|Prasugrel 30/5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
10955344|NCT00830960|OG003|Outcome|Clopidogrel 300/75 PD|Population includes participants in genetics substudy who were randomly assigned to receive a clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
10955345|NCT00830960|EG000|Reported Event|Prasugrel 60/10 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 60 mg followed by maintenance dose 10 mg/day.
10955346|NCT00830960|EG001|Reported Event|Prasugrel 30/7.5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30mg followed by maintenance dose 7.5 mg/day
10955347|NCT00830960|EG002|Reported Event|Prasugrel 30/5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
10955348|NCT00830960|EG003|Reported Event|Clopidogrel 300/75 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
10955349|NCT00830960|EG004|Reported Event|Prasugrel 30/5 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
10955350|NCT00830960|EG005|Reported Event|Clopidogrel 300/75 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
10955351|NCT00830960|EG006|Reported Event|Clopidogrel 300/75 No Weight|Participant didn't have weight recorded. Loading dose 300 mg followed by maintenance dose 75 mg/day
10955352|NCT00831129|BG000|Baseline|Placebo|simvastatin 40 mg/day plus placebo
10955353|NCT00831129|BG001|Baseline|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
10955354|NCT00831129|BG002|Baseline|Total|Total of all reporting groups
10955355|NCT00831129|FG000|Participant Flow|Placebo|simvastatin 40 mg/day plus placebo
10955356|NCT00831129|FG001|Participant Flow|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
10955357|NCT00831129|OG000|Outcome|Placebo|simvastatin 40 mg/day plus placebo
10955358|NCT00831129|OG001|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
10955359|NCT00831129|EG000|Reported Event|Placebo|simvastatin 40 mg/day plus placebo
11234394|NCT02434770|EG002|Reported Event|BioFarma bOPV|Infants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
10955360|NCT00831129|EG001|Reported Event|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
10955361|NCT00831181|BG000|Baseline|Chemoradiation,Surgery, Chemotherapy|Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6
10955362|NCT00831181|FG000|Participant Flow|Oxaliplatin/5-FU Followed by Mesorectal Excision and FOLFOX 6|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
10955363|NCT00831181|OG000|Outcome|Chemoradiation,Surgery, Chemotherapy|Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6
10955364|NCT00831181|OG000|Outcome|Chemoradiation,Surgery, Chemotherapy|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
10955365|NCT00831181|EG000|Reported Event|Chemoradiation,Surgery, Chemotherapy|Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6
10955366|NCT00831233|BG000|Baseline|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
10955367|NCT00831233|BG001|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
10955368|NCT00831233|BG002|Baseline|Total|Total of all reporting groups
10955369|NCT00831233|FG000|Participant Flow|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
10955370|NCT00831233|FG001|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
10955371|NCT00831233|OG000|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
10955372|NCT00831233|OG001|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
10955373|NCT00831233|EG000|Reported Event|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
10955374|NCT00831233|EG001|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
10955375|NCT00831272|BG000|Baseline|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
10955376|NCT00831272|BG001|Baseline|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
10955377|NCT00831272|BG002|Baseline|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
10955378|NCT00831272|BG003|Baseline|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
10955379|NCT00831272|BG004|Baseline|Total|Total of all reporting groups
10955380|NCT00831272|FG000|Participant Flow|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
10955381|NCT00831272|FG001|Participant Flow|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
10955382|NCT00831272|FG002|Participant Flow|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
10955383|NCT00831272|FG003|Participant Flow|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
10955384|NCT00831272|OG000|Outcome|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
10955385|NCT00831272|OG001|Outcome|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
11178734|NCT02050048|EG001|Reported Event|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
10955386|NCT00831272|OG002|Outcome|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
10955387|NCT00831272|OG003|Outcome|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
10955388|NCT00831272|EG000|Reported Event|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
10955389|NCT00831272|EG001|Reported Event|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
10955390|NCT00831272|EG002|Reported Event|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
11178735|NCT02050321|BG000|Baseline|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
10955391|NCT00831272|EG003|Reported Event|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
10955392|NCT00831311|BG000|Baseline|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
10955393|NCT00831311|BG001|Baseline|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
10955394|NCT00831311|BG002|Baseline|Total|Total of all reporting groups
10955395|NCT00831311|FG000|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
10955396|NCT00831311|FG001|Participant Flow|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
10955397|NCT00831311|OG000|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
10955398|NCT00831311|OG001|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
10955399|NCT00831311|OG001|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
10955400|NCT00831311|EG000|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
10955401|NCT00831311|EG001|Reported Event|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
10955402|NCT00831389|BG000|Baseline|First Closed Loop, Then Standard of Care or Open Loop|First Closed Loop, Then Standard of Care or Open Loop
10955403|NCT00831389|BG001|Baseline|First Standard of Care or Open Loop, Then CLosed Loop|First Standard of Care or Open Loop, Then CLosed Loop
10955404|NCT00831389|BG002|Baseline|Total|Total of all reporting groups
10955405|NCT00831389|FG000|Participant Flow|First Standard of Care or Open Loop, Then CLosed Loop|All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
10955406|NCT00831389|FG001|Participant Flow|First Closed Loop, Then Standard of Care or Open Loop|All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
11192335|NCT02138227|OG008|Outcome|Senior Post-Intervention Requester Comfort (Assisted)|Mean level of comfort senior staff self-reported post-intervention in the assisted arm. Senior participants are defined has having more than 36 months of experience.
11178736|NCT02050321|FG000|Participant Flow|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
11178737|NCT02050321|OG000|Outcome|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
11178738|NCT02050321|EG000|Reported Event|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
11178739|NCT02050334|BG000|Baseline|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
11178740|NCT02050334|BG001|Baseline|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
11178741|NCT02050334|BG002|Baseline|Total|Total of all reporting groups
11178742|NCT02050334|FG000|Participant Flow|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
11178743|NCT02050334|FG001|Participant Flow|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
11178744|NCT02050334|OG000|Outcome|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
10955407|NCT00831389|OG000|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
10955408|NCT00831389|OG001|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
10955409|NCT00831389|EG000|Reported Event|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
11178745|NCT02050334|OG001|Outcome|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
11178746|NCT02050334|OG000|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
11178747|NCT02050334|EG000|Reported Event|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
11178748|NCT02050334|EG001|Reported Event|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
11178749|NCT02050373|BG000|Baseline|Low-Level Laser|In the laser group, an indium phosphide, galium and aluminum (InGaAIP) diode laser (660nm, 40mW, 0.16 J, 4 J/cm2) was used to irradiate oral mucosa. 27 Subjects received the LLLT from the first day of the conditioning regimen and continued until D+7. Laser therapy was applied by a single dentist expertise in laser irradiation. The tip touched the mucosa of the lips, right and left buccal mucosa, right and left lateral tongue, ventral tongue and buccal floor, giving a total of 10 points per region. Low-Level laser: Application of laser therapy in low power mucosa jugal right and left upper and lower labial mucosa, floor of the mouth, tongue side of the right and left and belly of the tongue.
11178750|NCT02050373|BG001|Baseline|Control|In the control group, 24 patients receive only the preventive protocol bone marrow transplant industry, consisting of mouthwashes and sodium fluoride. For ethical reasons, individuals who present oral mucositis grade 2 (WHO) will receive LLLT.
11178751|NCT02050373|BG002|Baseline|Total|Total of all reporting groups
11192336|NCT02138227|EG000|Reported Event|Assisted CEaD Condition|"In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.~Assisted CEaD Condition: In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills. OPO requesters will be assisted by having the CEaD DVD supplemented through working the scenarios with live simulated patients who will be trained to act out the scenarios with the OPO requesters and provide feedback."
10955410|NCT00831389|EG001|Reported Event|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
10955411|NCT00831415|BG000|Baseline|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
10955412|NCT00831415|FG000|Participant Flow|DVS SR|Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day.
10955413|NCT00831415|OG000|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
10955414|NCT00831415|EG000|Reported Event|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
10955415|NCT00831428|BG000|Baseline|Scottish Swimming Team|
10955416|NCT00831428|FG000|Participant Flow|Scottish Swimming Team|
11178752|NCT02050373|FG000|Participant Flow|Low-Level Laser|"In the laser group, an indium phosphide, galium and aluminum (InGaAIP) diode laser (660nm, 40mW, 0.16 J, 4 J/cm2) was used to irradiate oral mucosa. Subjects received the LLLT from the first day of the conditioning regimen and continued until D+7. Laser therapy was applied by a single dentist expertise in laser irradiation. The tip touched the mucosa of the lips, right and left buccal mucosa, right and left lateral tongue, ventral tongue and buccal floor, giving a total of 10 points per region.~Low-Level laser: Application of laser therapy in low power mucosa jugal right and left upper and lower labial mucosa, floor of the mouth, tongue side of the right and left and belly of the tongue."
11178753|NCT02050373|FG001|Participant Flow|Controll|In the control group, patients receive only the preventive protocol bone marrow transplant industry, consisting of mouthwashes and sodium fluoride. For ethical reasons, individuals who present oral mucositis grade 2 (WHO) will receive LLLT.
11178754|NCT02050373|OG000|Outcome|Low-Level Laser|In the laser group, an indium phosphide, galium and aluminum (InGaAIP) diode laser (660nm, 40mW, 0.16 J, 4 J/cm2) was used to irradiate oral mucosa. Subjects received the LLLT from the first day of the conditioning regimen and continued until D+7. Laser therapy was applied by a single dentist expertise in laser irradiation. The tip touched the mucosa of the lips, right and left buccal mucosa, right and left lateral tongue, ventral tongue and buccal floor, giving a total of 10 points per region. Application of laser therapy in low power mucosa jugal right and left upper and lower labial mucosa, floor of the mouth, tongue side of the right and left and belly of the tongue.
11178755|NCT02050373|OG001|Outcome|Control|In the control group, patients receive instructions on the oral hygiene protocol (dental brushing after meals, dental flossing once a day and an alcohol-free 0.12% mouthwash twice a day). For ethical reasons, individuals who present oral mucositis grade 2 (WHO) will receive LLLT.
10955417|NCT00831428|OG000|Outcome|Scottish Swimming Team|
10955418|NCT00831428|EG000|Reported Event|Scottish Swimming Team|
10955419|NCT00831441|BG000|Baseline|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
10955420|NCT00831441|BG001|Baseline|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily.
10955421|NCT00831441|BG002|Baseline|Total|Total of all reporting groups
10955422|NCT00831441|FG000|Participant Flow|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
10955423|NCT00831441|FG001|Participant Flow|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
10955424|NCT00831441|OG000|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
10955425|NCT00831441|OG001|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated in Year 2.
10955426|NCT00831441|OG001|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
10955427|NCT00831441|EG000|Reported Event|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
10955428|NCT00831441|EG001|Reported Event|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
10955429|NCT00831480|BG000|Baseline|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
10955430|NCT00831480|FG000|Participant Flow|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
10955431|NCT00831480|OG000|Outcome|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
10955432|NCT00831480|EG000|Reported Event|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
10955433|NCT00831493|BG000|Baseline|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
10955434|NCT00831493|FG000|Participant Flow|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
10955435|NCT00831493|OG000|Outcome|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
10955436|NCT00831493|EG000|Reported Event|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
10955437|NCT00831675|BG000|Baseline|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
10955438|NCT00831675|BG001|Baseline|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
10955439|NCT00831675|BG002|Baseline|Total|Total of all reporting groups
10955440|NCT00831675|FG000|Participant Flow|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
10955441|NCT00831675|FG001|Participant Flow|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
10955442|NCT00831675|OG000|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
10955443|NCT00831675|OG001|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
10955444|NCT00831675|EG000|Reported Event|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
10955445|NCT00831675|EG001|Reported Event|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
10955446|NCT00831701|BG000|Baseline|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
10955447|NCT00831701|BG001|Baseline|Placebo Treatment|Patients received Placebo pill once daily
10955448|NCT00831701|BG002|Baseline|Total|Total of all reporting groups
10955449|NCT00831701|FG000|Participant Flow|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
10955450|NCT00831701|FG001|Participant Flow|Placebo Treatment|Patients received Placebo pill once daily
11341765|NCT03687827|OG001|Outcome|Insulin Glargine 100U/mL|Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
10955451|NCT00831701|OG000|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
10955452|NCT00831701|OG001|Outcome|Placebo Treatment|Patients received Placebo pill once daily
10955453|NCT00831701|EG000|Reported Event|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
10955454|NCT00831701|EG001|Reported Event|Placebo Treatment|Patients received Placebo pill once daily
10955455|NCT00831753|BG000|Baseline|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
10955456|NCT00831753|BG001|Baseline|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
10955457|NCT00831753|BG002|Baseline|Total|Total of all reporting groups
10955458|NCT00831753|FG000|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
10955459|NCT00831753|FG001|Participant Flow|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
10955460|NCT00831753|OG000|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
10955461|NCT00831753|OG001|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
10955462|NCT00831753|EG000|Reported Event|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
10955463|NCT00831753|EG001|Reported Event|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
10955464|NCT00831766|BG000|Baseline|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.~Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
10955465|NCT00831766|BG001|Baseline|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: Maximum Tolerated Dose (MTD).~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
10955466|NCT00831766|BG002|Baseline|Total|Total of all reporting groups
10955467|NCT00831766|FG000|Participant Flow|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.~Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
10955468|NCT00831766|FG001|Participant Flow|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: Maximum Tolerated Dose (MTD).~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
10955469|NCT00831766|OG000|Outcome|Phase I Participants|Dose escalation group.
10955470|NCT00831766|OG000|Outcome|All Participants Treated at MTD|All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).
10955471|NCT00831766|OG000|Outcome|Maintenance Phase Participants|All participants treated in the Maintenance Phase.
10955472|NCT00831766|EG000|Reported Event|Phase I: Dose Escalation|Participants enrolled during Phase I.
10955473|NCT00831766|EG001|Reported Event|Phase II: Treatment at MTD|Participants enrolled during Phase II.
10955474|NCT00831779|BG000|Baseline|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
10955475|NCT00831779|BG001|Baseline|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
10955476|NCT00831779|BG002|Baseline|Total|Total of all reporting groups
10955477|NCT00831779|FG000|Participant Flow|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
10955478|NCT00831779|FG001|Participant Flow|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
10955479|NCT00831779|OG000|Outcome|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
11178756|NCT02050373|OG000|Outcome|LLLT|Patients in the LLLT group received applications from the first day of the conditioning regimen and continued every day until the seventh post-transplant day (D+7), at approximately the same time each day. Applications were made by the same professional expert laser therapy and in compliance with all necessary biosafety protocols.
10955480|NCT00831779|OG001|Outcome|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
10955481|NCT00831779|EG000|Reported Event|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
10955482|NCT00831779|EG001|Reported Event|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
10955483|NCT00831792|BG000|Baseline|All Patients Enrolled and Treated With TKI 258|Patients with castrate-resistant prostate cancer
10955484|NCT00831792|FG000|Participant Flow|Eligible Patients|All patients enrolled and treated with TKI 258
10955485|NCT00831792|OG000|Outcome|APatients on Observational Study of TKI258|Patients with histologically confirmed adenocarcinoma of the prostate with bone metastases
10955486|NCT00831792|EG000|Reported Event|All Patients Enrolled and Treated With TKI 258|Patients with castrate-resistant prostate cancer
10955487|NCT00831844|BG000|Baseline|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955488|NCT00831844|BG001|Baseline|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955489|NCT00831844|BG002|Baseline|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
11192337|NCT02138227|EG001|Reported Event|Autonomous CEaD Condition|"In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.~Autonomous CEaD Condition: In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide."
10955490|NCT00831844|BG003|Baseline|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955491|NCT00831844|BG004|Baseline|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955492|NCT00831844|BG005|Baseline|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955493|NCT00831844|BG006|Baseline|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955494|NCT00831844|BG007|Baseline|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955495|NCT00831844|BG008|Baseline|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955496|NCT00831844|BG009|Baseline|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955497|NCT00831844|BG010|Baseline|Total|Total of all reporting groups
11178757|NCT02050373|EG000|Reported Event|Low-Level Laser|In the laser group, an indium phosphide, galium and aluminum (InGaAIP) diode laser (660nm, 40mW, 0.16 J, 4 J/cm2) was used to irradiate oral mucosa. Subjects received the LLLT from the first day of the conditioning regimen and continued until D+7. Laser therapy was applied by a single dentist expertise in laser irradiation. The tip touched the mucosa of the lips, right and left buccal mucosa, right and left lateral tongue, ventral tongue and buccal floor, giving a total of 10 points per region. Application of laser therapy in low power mucosa jugal right and left upper and lower labial mucosa, floor of the mouth, tongue side of the right and left and belly of the tongue.
10955498|NCT00831844|FG000|Participant Flow|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955499|NCT00831844|FG001|Participant Flow|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955500|NCT00831844|FG002|Participant Flow|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955501|NCT00831844|FG003|Participant Flow|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955502|NCT00831844|FG004|Participant Flow|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955503|NCT00831844|FG005|Participant Flow|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955504|NCT00831844|FG006|Participant Flow|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955505|NCT00831844|FG007|Participant Flow|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
11178758|NCT02050373|EG001|Reported Event|Control|In the control group, patients receive instructions on the oral hygiene protocol (dental brushing after meals, dental flossing once a day and an alcohol-free 0.12% mouthwash twice a day). For ethical reasons, individuals who present oral mucositis grade 2 (WHO) will receive LLLT.
10955506|NCT00831844|FG008|Participant Flow|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955507|NCT00831844|FG009|Participant Flow|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955508|NCT00831844|OG000|Outcome|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955509|NCT00831844|OG001|Outcome|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955510|NCT00831844|OG002|Outcome|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955511|NCT00831844|OG003|Outcome|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955512|NCT00831844|OG004|Outcome|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955513|NCT00831844|OG005|Outcome|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955514|NCT00831844|OG006|Outcome|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955515|NCT00831844|OG007|Outcome|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955516|NCT00831844|OG008|Outcome|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955517|NCT00831844|OG009|Outcome|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955518|NCT00831844|EG000|Reported Event|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955519|NCT00831844|EG001|Reported Event|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955520|NCT00831844|EG002|Reported Event|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955521|NCT00831844|EG003|Reported Event|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955522|NCT00831844|EG004|Reported Event|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
11178759|NCT02050841|BG000|Baseline|Octaplas|"Qualified patients will receive Octaplas as per protocol.~octaplas: Octaplas S/D Plasma"
11178760|NCT02050841|FG000|Participant Flow|Octaplas|"Qualified patients will receive Octaplas as per protocol.~octaplas: Octaplas S/D Plasma"
11178761|NCT02050841|OG000|Outcome|Octaplas|"Qualified patients will receive Octaplas as per protocol.~octaplas: Octaplas S/D Plasma"
10955523|NCT00831844|EG005|Reported Event|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955524|NCT00831844|EG006|Reported Event|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955525|NCT00831844|EG007|Reported Event|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955526|NCT00831844|EG008|Reported Event|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
10955527|NCT00831844|EG009|Reported Event|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
11178762|NCT02050841|OG000|Outcome|Children >2 Years|"Qualified patients will receive Octaplas as per protocol.~octaplas: Octaplas S/D Plasma"
11178763|NCT02050841|OG001|Outcome|Infants ≤2 Years|"Qualified patients will receive Octaplas as per protocol.~octaplas: Octaplas S/D Plasma"
11178764|NCT02050841|OG000|Outcome|EPL30-TEG|Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by EPL30-TEG (estimated percent lysis)
10955528|NCT00831987|BG000|Baseline|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
11178765|NCT02050841|OG001|Outcome|ML30-ROTEM|Number of Participants WithClinically Significant Changes in Hemostatic Parameters as Measured byThromboelastometry (ROTEM).
11234395|NCT02434939|BG000|Baseline|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
10955529|NCT00831987|BG001|Baseline|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
10955530|NCT00831987|BG002|Baseline|Total|Total of all reporting groups
10955531|NCT00831987|FG000|Participant Flow|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
10955532|NCT00831987|FG001|Participant Flow|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
10955533|NCT00831987|OG000|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
10955534|NCT00831987|OG001|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
10955535|NCT00831987|EG000|Reported Event|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
10955536|NCT00831987|EG001|Reported Event|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
10955537|NCT00832000|BG000|Baseline|All Study Participants|All participants received all inerventions; therefore, we combined all participants into one Arm/Group.
10955538|NCT00832000|FG000|Participant Flow|Mexiletine Then Placebo|"29 Participants will receive mexiletine for 4 weeks, then no intervention for 1 week, and finally placebo for 4 weeks.~Included in anaysis*: 28 patients~*Modified intention to treat analysis. 1 subject in each group not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period"
11178766|NCT02050841|OG000|Outcome|Octaplas - Pre-Infusion|Pre-Infusion Vital Signs
11178767|NCT02050841|OG001|Outcome|Octaplas - Post-Infusion|Post-Infusion Vital Signs
11178768|NCT02050841|EG000|Reported Event|Octaplas|"Qualified patients will receive Octaplas as per protocol.~octaplas: Octaplas S/D Plasma"
11178769|NCT02051296|BG000|Baseline|Minocycline|"perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID~Minocycline: RCT blinded placebo trial"
11178770|NCT02051296|BG001|Baseline|Placebo|"PLacebo~placebo"
11178771|NCT02051296|BG002|Baseline|Total|Total of all reporting groups
11178772|NCT02051296|FG000|Participant Flow|Minocycline|"perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID for 5 days~Minocycline: RCT blinded placebo trial"
11178773|NCT02051296|FG001|Participant Flow|Placebo|"Placebo: two pills 2 hours prior to surgery then 1 pill BID~placebo"
11178774|NCT02051296|OG000|Outcome|Minocycline|"perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID~Minocycline: RCT blinded placebo trial"
11178775|NCT02051296|OG001|Outcome|Placebo|"PLacebo~placebo"
11178776|NCT02051296|EG000|Reported Event|Minocycline|"perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID~Minocycline: RCT blinded placebo trial"
11178777|NCT02051296|EG001|Reported Event|Placebo|"PLacebo~placebo"
11178778|NCT02051335|BG000|Baseline|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
10955539|NCT00832000|FG001|Participant Flow|Placebo Then Mexiletine|"30 Participants will receive placebo for 4 weeks, then no intervention for 1 week, and finally mexiletine for 4 weeks.~Included in analysis* 29 patients~*Modified intention to treat analysis. 1 subject in each not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period."
10955540|NCT00832000|OG000|Outcome|Mexiletine - Period 1|Mexiletine capsules 200 mg orally three times daily period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
10955541|NCT00832000|OG001|Outcome|Placebo - Period 1|Placebo capsules orally three times dailyperiod 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
10955542|NCT00832000|OG002|Outcome|Mexiletine - Period 2|Mexiletine capsules 200 mg orally three times daily period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
10955543|NCT00832000|OG003|Outcome|Placebo - Period 2|Placebo capsules orally three times dailyperiod 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
10955544|NCT00832000|OG000|Outcome|Mexiletine|Participants experiencing pain on mexiletine capsules 200 mg orally three times daily in period 1 or period 2
10955545|NCT00832000|OG001|Outcome|Placebo|Participants experiencing pain on placebo capsules orally three times dailyin period 1 or period 2
10955546|NCT00832000|OG000|Outcome|Mexiletine|Particiapnts who experienced weakness on mexiletine capsules 200 mg orally three times daily in either period 1 or period 2.
10955547|NCT00832000|OG001|Outcome|Placebo|Particiapnts who experienced weakness on placebo capsules orally three times daily in either period 1 or period 2.
10955548|NCT00832000|OG000|Outcome|Mexiletine|Particiapnts who experienced tiredness on mexiletine 200 mg capsules orally three times daily in either period 1 or period 2.
10955549|NCT00832000|OG001|Outcome|Placebo|Particiapnts who experienced tiredness on placebo capsules orally three times daily in either period 1 or period 2.
10955550|NCT00832000|OG000|Outcome|Mexiletine|Average 90% to 5% hand grip relaxation time for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
10955551|NCT00832000|OG001|Outcome|Placebo|Average 90% to 5% hand grip relaxation time for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
10955552|NCT00832000|OG000|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percent of baseline measurement) for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
10955553|NCT00832000|OG001|Outcome|Placebo|Post exercise CMAP amplitude (as a percento f baseline measurement) for particpants receiving mexiletine capsules orally three times daily either in period 1 or period 2
10955554|NCT00832000|OG000|Outcome|Mexiletine|Graded myotonia in right ADM for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
10955555|NCT00832000|OG001|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
10955556|NCT00832000|OG000|Outcome|Mexiletine|Average time to open the fist after forced hand grip for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
10955557|NCT00832000|OG001|Outcome|Placebo|Average time to open the fist after forced hand grip for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
10955558|NCT00832000|OG000|Outcome|Mexiletine|Average time to open eyes after forced eye closure for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
10955559|NCT00832000|OG001|Outcome|Placebo|Average time to open eyes after forced eye closure for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
10955560|NCT00832000|OG000|Outcome|Mexiletine|Graded myotonia in right TA for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
10955561|NCT00832000|OG000|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percentage of baseline measreument) for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
10955562|NCT00832000|OG001|Outcome|Placebo|Post exercise CMAP amplitude ( as a percentage of baseline measurement) for participants receiving placebo capsules orally three times daily either in period 1 or period 2
10955563|NCT00832000|OG000|Outcome|Mexiletine|INQoL summary score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
10955564|NCT00832000|OG001|Outcome|Placebo|INQoL summary score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
10955565|NCT00832000|OG000|Outcome|Mexiletine|SF-36 physical composite score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
10955566|NCT00832000|OG001|Outcome|Placebo|SF-36 physical composite score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
10955567|NCT00832000|OG000|Outcome|Mexiletine - Period 1|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
10955568|NCT00832000|OG001|Outcome|Placebo - Period 1|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
10955569|NCT00832000|OG002|Outcome|Mexiletine - Period 2|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
10955570|NCT00832000|OG003|Outcome|Placebo - Period 2|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
10955571|NCT00832000|EG000|Reported Event|Mexiletine Treatment|Adverse events that occurred when patients were taking placebo.
10955572|NCT00832000|EG001|Reported Event|Placebo Treatment|Adverse events that occurred when patients were taking mexiletine.
10955573|NCT00832078|BG000|Baseline|Entire Study Population|
10955574|NCT00832078|FG000|Participant Flow|Group A|Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant
10955575|NCT00832078|FG001|Participant Flow|Group B|Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant
10955576|NCT00832078|OG000|Outcome|Test Catheter SCCM|The Test catheter SpeediCath Compact Male (SCCM)
10955577|NCT00832078|OG001|Outcome|Standard Catheter SC|The Stanard catheter SpeediCath (SC)
10955578|NCT00832078|EG000|Reported Event|Test Catheter|
10955579|NCT00832078|EG001|Reported Event|Standard Catheter|
10955580|NCT00832091|BG000|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
10955581|NCT00832091|BG001|Baseline|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
10955582|NCT00832091|BG002|Baseline|Total|Total of all reporting groups
10955583|NCT00832091|FG000|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
10955584|NCT00832091|FG001|Participant Flow|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
10955585|NCT00832091|OG000|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
10955586|NCT00832091|OG001|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
10955587|NCT00832091|EG000|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
10955588|NCT00832091|EG001|Reported Event|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
10955589|NCT00832117|BG000|Baseline|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
11234396|NCT02434939|BG001|Baseline|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
10955590|NCT00832117|BG001|Baseline|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
10955591|NCT00832117|BG002|Baseline|Total|Total of all reporting groups
10955592|NCT00832117|FG000|Participant Flow|All Enrolled Participants|Participants received both ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 and ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle.
10955593|NCT00832117|OG000|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
10955594|NCT00832117|OG001|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
10955595|NCT00832117|OG000|Outcome|All Treated Participants|All participants who received at least 1 dose of either ixabepilone or carboplatin
10955596|NCT00832117|EG000|Reported Event|Ixa 32 mg/m2 + Cis 60 mg/m2|6 participants with solid tumor (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) for NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
10955597|NCT00832117|EG001|Reported Event|Ixa 32 mg/m2 +Cis 80 mg/m2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
10955598|NCT00832130|BG000|Baseline|Manual Mini System|Treatment with experimental Manual Mini System
10955599|NCT00832130|BG001|Baseline|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
10955600|NCT00832130|BG002|Baseline|Total|Total of all reporting groups
10955601|NCT00832130|FG000|Participant Flow|Manual Mini System|Treatment with experimental Manual Mini System
10955602|NCT00832130|FG001|Participant Flow|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
10955603|NCT00832130|OG000|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
10955604|NCT00832130|OG001|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
10955605|NCT00832130|EG000|Reported Event|Manual Mini System|Treatment with experimental Manual Mini System
10955606|NCT00832130|EG001|Reported Event|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
10955607|NCT00832260|BG000|Baseline|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
10955608|NCT00832260|FG000|Participant Flow|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
10955609|NCT00832260|OG000|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
10955610|NCT00832260|EG000|Reported Event|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
10955611|NCT00832338|BG000|Baseline|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
11234397|NCT02434939|BG002|Baseline|Total|Total of all reporting groups
10955612|NCT00832338|FG000|Participant Flow|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
10955613|NCT00832338|OG000|Outcome|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
10955614|NCT00832338|EG000|Reported Event|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
10955615|NCT00832377|BG000|Baseline|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
10955616|NCT00832377|FG000|Participant Flow|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
10955617|NCT00832377|OG000|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
10955618|NCT00832377|EG000|Reported Event|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
10955619|NCT00832390|BG000|Baseline|Sitagliptin 100 mg q.d. (Once Daily)|
10955620|NCT00832390|BG001|Baseline|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
10955621|NCT00832390|BG002|Baseline|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
10955622|NCT00832390|BG003|Baseline|Total|Total of all reporting groups
10955623|NCT00832390|FG000|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily)|
11178779|NCT02051335|BG001|Baseline|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
11178780|NCT02051335|BG002|Baseline|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
11178781|NCT02051335|BG003|Baseline|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
11178782|NCT02051335|BG004|Baseline|Total|Total of all reporting groups
11178783|NCT02051335|FG000|Participant Flow|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
11234398|NCT02434939|FG000|Participant Flow|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
10955624|NCT00832390|FG001|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
10955625|NCT00832390|FG002|Participant Flow|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
10955626|NCT00832390|OG000|Outcome|Sitagliptin 100 mg q.d. (Once Daily)|
10955627|NCT00832390|OG001|Outcome|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
10955628|NCT00832390|OG002|Outcome|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
10955629|NCT00832390|EG000|Reported Event|Sitagliptin 100 mg q.d. (Once Daily)|
10955630|NCT00832390|EG001|Reported Event|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
10955631|NCT00832390|EG002|Reported Event|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
10955632|NCT00832416|BG000|Baseline|1: Tramadol Once A Day 100mg|
10955633|NCT00832416|BG001|Baseline|2: Tramadol Once A Day 200mg|
10955634|NCT00832416|BG002|Baseline|3: Tramadol Once A Day 300mg|
10955635|NCT00832416|BG003|Baseline|4: Placebo|
10955636|NCT00832416|BG004|Baseline|Total|Total of all reporting groups
10955637|NCT00832416|FG000|Participant Flow|1: Tramadol Once A Day 100mg|
10955638|NCT00832416|FG001|Participant Flow|2: Tramadol Once A Day 200mg|
10955639|NCT00832416|FG002|Participant Flow|3: Tramadol Once A Day 300mg|
10955640|NCT00832416|FG003|Participant Flow|4: Placebo|
10955641|NCT00832416|OG000|Outcome|1: Tramadol Once A Day 100mg|
10955642|NCT00832416|OG001|Outcome|2: Tramadol Once A Day 200mg|
10955643|NCT00832416|OG002|Outcome|3: Tramadol Once A Day 300mg|
10955644|NCT00832416|OG003|Outcome|4: Placebo|
10955645|NCT00832416|EG000|Reported Event|1: Tramadol Once A Day 100mg|
10955646|NCT00832416|EG001|Reported Event|2: Tramadol Once A Day 200mg|
10955647|NCT00832416|EG002|Reported Event|3: Tramadol Once A Day 300mg|
11234399|NCT02434939|FG001|Participant Flow|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
11341766|NCT03687827|EG000|Reported Event|Insulin Degludec 100U/mL|Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
10955648|NCT00832416|EG003|Reported Event|4: Placebo|
10955649|NCT00832585|BG000|Baseline|Alefacept|"Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other biologics for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks."
10955650|NCT00832585|FG000|Participant Flow|Alefacept|"Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other biologics for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks."
10955651|NCT00832585|OG000|Outcome|Alefacept|"Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other biologics for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks."
10955652|NCT00832585|EG000|Reported Event|Alefacept|"Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other biologics for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks."
10955653|NCT00832637|BG000|Baseline|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
10955654|NCT00832637|FG000|Participant Flow|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
10955655|NCT00832637|OG000|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
10955656|NCT00832637|EG000|Reported Event|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
10955657|NCT00832650|BG000|Baseline|Fesoterodine|Fesoterodine 8 mg tablet once daily
10955658|NCT00832650|BG001|Baseline|Placebo|Matched placebo tablet or capsule
10955659|NCT00832650|BG002|Baseline|Solifenacin|Solifenacin 10 mg capsule once daily
10955660|NCT00832650|BG003|Baseline|Total|Total of all reporting groups
10955661|NCT00832650|FG000|Participant Flow|Fesoterodine|Fesoterodine 8 mg tablet once daily
10955662|NCT00832650|FG001|Participant Flow|Placebo|Matched placebo tablet or capsule
10955663|NCT00832650|FG002|Participant Flow|Solifenacin|Solifenacin 10 mg capsule once daily
10955664|NCT00832650|OG000|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
10955665|NCT00832650|OG001|Outcome|Placebo|Matched placebo tablet or capsule
10955666|NCT00832650|OG002|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
10955667|NCT00832650|EG000|Reported Event|Fesoterodine|Fesoterodine 8 mg tablet once daily
10955668|NCT00832650|EG001|Reported Event|Placebo|Matched placebo tablet or capsule
10955669|NCT00832650|EG002|Reported Event|Solifenacin|Solifenacin 10 mg capsule once daily
10955670|NCT00832767|BG000|Baseline|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
10955671|NCT00832767|BG001|Baseline|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
10955672|NCT00832767|BG002|Baseline|Total|Total of all reporting groups
10955673|NCT00832767|FG000|Participant Flow|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
10955674|NCT00832767|FG001|Participant Flow|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
10955675|NCT00832767|OG000|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
10955676|NCT00832767|OG001|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
10955677|NCT00832767|OG000|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
11234400|NCT02434939|OG000|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
10955678|NCT00832767|OG001|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
10955679|NCT00832767|EG000|Reported Event|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
10955680|NCT00832767|EG001|Reported Event|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
10955681|NCT00832780|BG000|Baseline|60 Gy Using 12 Gy Per Fraction Over 5 Fractions|Radiation dose of 60 Gy administered in 5 fractions of 12 Gy each.
10955682|NCT00832780|FG000|Participant Flow|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
10955683|NCT00832780|OG000|Outcome|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
10955684|NCT00832780|EG000|Reported Event|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
10955685|NCT00832819|BG000|Baseline|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (Area under the curve (AUC) 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
10955686|NCT00832819|BG001|Baseline|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
10955687|NCT00832819|BG002|Baseline|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
11178784|NCT02051335|FG001|Participant Flow|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
11178785|NCT02051335|FG002|Participant Flow|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
11178786|NCT02051335|FG003|Participant Flow|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
10955688|NCT00832819|BG003|Baseline|Total|Total of all reporting groups
10955689|NCT00832819|FG000|Participant Flow|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
10955690|NCT00832819|FG001|Participant Flow|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
10955691|NCT00832819|FG002|Participant Flow|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
10955692|NCT00832819|OG000|Outcome|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
11178787|NCT02051335|OG000|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
10955693|NCT00832819|EG000|Reported Event|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
10955694|NCT00832819|EG001|Reported Event|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
11178788|NCT02051335|OG001|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
10955695|NCT00832819|EG002|Reported Event|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
10955696|NCT00832871|BG000|Baseline|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
10955697|NCT00832871|FG000|Participant Flow|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
10955698|NCT00832871|OG000|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
10955699|NCT00832871|EG000|Reported Event|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
10955700|NCT00832975|BG000|Baseline|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
10955701|NCT00832975|FG000|Participant Flow|St Jude Medical ICD/CRT-D|St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients
10955702|NCT00832975|OG000|Outcome|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
10955703|NCT00832975|EG000|Reported Event|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
10955704|NCT00833027|BG000|Baseline|Sitagliptin 100mg|
10955705|NCT00833027|FG000|Participant Flow|Sitagliptin 100mg|
10955706|NCT00833027|OG000|Outcome|Sitagliptin 100mg|
10955707|NCT00833027|EG000|Reported Event|Sitagliptin 100mg|
10955708|NCT00833040|BG000|Baseline|Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to the effective dosage of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken as needed for breakthrough pain.~During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active (dosage determined in Titration Phase) and three placebo doses taken in random order per. One NanoTab™ was taken as needed for breakthrough pain."
10955709|NCT00833040|FG000|Participant Flow|Sequence 1|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 1 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
10955710|NCT00833040|FG001|Participant Flow|Sequence 2|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 2 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
10955711|NCT00833040|FG002|Participant Flow|Sequence 3|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 3 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 5th, and 9th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
10955712|NCT00833040|FG003|Participant Flow|Sequence 4|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 4 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 5th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
10955713|NCT00833040|FG004|Participant Flow|Sequence 5|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 5 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
10955714|NCT00833040|FG005|Participant Flow|Sequence 6|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 6 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 10th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
10955715|NCT00833040|OG000|Outcome|Double Blind Phase of 7 Sufentanil Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
10955716|NCT00833040|OG001|Outcome|Double Blind Phase of 3 Pbo Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
10955717|NCT00833040|EG000|Reported Event|Titration of Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to their personal effective strength of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken for each episode of breakthrough pain.~During the Double-Blind Phase, patients were randomized to one of six treatment sequences, each of which included seven active doses (the strength determined in Titration Phase) and three placebo doses. The ten doses were in random order. One NanoTab™ was taken for each episode of breakthrough pain."
10955718|NCT00833053|BG000|Baseline|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
10955719|NCT00833053|BG001|Baseline|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
10955720|NCT00833053|BG002|Baseline|Total|Total of all reporting groups
10955721|NCT00833053|FG000|Participant Flow|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
10955722|NCT00833053|FG001|Participant Flow|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
10955723|NCT00833053|OG000|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
10955724|NCT00833053|OG001|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
10955725|NCT00833053|EG000|Reported Event|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
10955726|NCT00833053|EG001|Reported Event|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
10955727|NCT00833092|BG000|Baseline|Sugar Pill|zero magnesium supplementation
10955728|NCT00833092|BG001|Baseline|Magnesium|300 milligrams of magnesium daily
11178789|NCT02051335|OG002|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
11178790|NCT02051335|OG003|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
10955729|NCT00833092|BG002|Baseline|Total|Total of all reporting groups
10955730|NCT00833092|FG000|Participant Flow|Sugar Pill|zero magnesium supplementation
10955731|NCT00833092|FG001|Participant Flow|Magnesium|300 milligrams of magnesium daily
10955732|NCT00833092|OG000|Outcome|Sugar Pill|zero magnesium supplementation
10955733|NCT00833092|OG001|Outcome|Magnesium|300 milligrams of magnesium daily
10955734|NCT00833092|EG000|Reported Event|Sugar Pill|zero magnesium supplementation
10955735|NCT00833092|EG001|Reported Event|Magnesium|300 milligrams of magnesium daily
10955736|NCT00833105|BG000|Baseline|AMES Treatment|"The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.~The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."
10955737|NCT00833105|FG000|Participant Flow|AMES Treatment|"The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.~AMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."
10955738|NCT00833105|OG000|Outcome|AMES Treatment|"The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.~The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."
10955739|NCT00833105|OG000|Outcome|AMES Treatment|"The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.~AMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."
10955740|NCT00833105|OG000|Outcome|AMES Treatment|"The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.~AMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."
11178791|NCT02051335|EG000|Reported Event|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
11178792|NCT02051335|EG001|Reported Event|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
10955741|NCT00833105|EG000|Reported Event|AMES Treatment|"The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.~AMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."
10955742|NCT00833248|BG000|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
10955743|NCT00833248|BG001|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
10955744|NCT00833248|BG002|Baseline|Total|Total of all reporting groups
10955745|NCT00833248|FG000|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
10955746|NCT00833248|FG001|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
10955747|NCT00833248|OG000|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
10955748|NCT00833248|OG001|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
10955749|NCT00833248|EG000|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
10955750|NCT00833248|EG001|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
10955751|NCT00833261|BG000|Baseline|Single Arm: Chemotherapy With Concurrent Radiation Therapy|Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
10955752|NCT00833261|FG000|Participant Flow|Single Arm: Chemotherapy With Concurrent Radiation Therapy|Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
10955753|NCT00833261|OG000|Outcome|Single Arm: Chemotherapy With Concurrent Radiation Therapy|Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
10955754|NCT00833261|EG000|Reported Event|Single Arm: Chemotherapy With Concurrent Radiation Therapy|Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
10955755|NCT00833365|BG000|Baseline|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
10955756|NCT00833365|BG001|Baseline|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
10955757|NCT00833365|BG002|Baseline|Total|Total of all reporting groups
10955758|NCT00833365|FG000|Participant Flow|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
10955759|NCT00833365|FG001|Participant Flow|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
10955760|NCT00833365|OG000|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
10955761|NCT00833365|OG001|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
11178793|NCT02051335|EG002|Reported Event|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
10955762|NCT00833365|EG000|Reported Event|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
10955763|NCT00833365|EG001|Reported Event|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
10955764|NCT00833417|BG000|Baseline|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
10955765|NCT00833417|BG001|Baseline|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
10955766|NCT00833417|BG002|Baseline|Total|Total of all reporting groups
10955767|NCT00833417|FG000|Participant Flow|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
10955768|NCT00833417|FG001|Participant Flow|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
10955769|NCT00833417|OG000|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
10955770|NCT00833417|OG001|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
10955771|NCT00833417|OG000|Outcome|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
10955772|NCT00833417|OG000|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
11357665|NCT03750955|OG000|Outcome|Plaque Induced Gingivitis|"Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.~Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues."
10955773|NCT00833417|EG000|Reported Event|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
10955774|NCT00833443|BG000|Baseline|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
10955775|NCT00833443|BG001|Baseline|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
10955776|NCT00833443|BG002|Baseline|Total|Total of all reporting groups
10955777|NCT00833443|FG000|Participant Flow|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
11178794|NCT02051335|EG003|Reported Event|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
11178795|NCT02051426|BG000|Baseline|D-serine First, Then Placebo|D-serine (2.1g), then placebo (corn starch)
11178796|NCT02051426|BG001|Baseline|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
11178797|NCT02051426|BG002|Baseline|Total|Total of all reporting groups
11178798|NCT02051426|FG000|Participant Flow|D-serine First, Then Placebo|D-serine (2.1g), then Placebo (corn starch)
11178799|NCT02051426|FG001|Participant Flow|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
11178800|NCT02051426|OG000|Outcome|D-serine|D-serine (2.1g)
11178801|NCT02051426|OG001|Outcome|Placebo|corn starch
11178802|NCT02051426|EG000|Reported Event|D-serine|D-serine (2.1g)
10955778|NCT00833443|FG001|Participant Flow|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
10955779|NCT00833443|OG000|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
10955780|NCT00833443|OG001|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
10955781|NCT00833443|OG000|Outcome|Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication adherence
10955782|NCT00833443|OG001|Outcome|NOT Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication NON-adherence
10955783|NCT00833443|EG000|Reported Event|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
10955784|NCT00833443|EG001|Reported Event|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
10955785|NCT00833469|BG000|Baseline|Escitalopram|"Flexible dose escitalopram 10mg~Escitalopram: Once daily by mouth"
10955786|NCT00833469|FG000|Participant Flow|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
10955787|NCT00833469|OG000|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
10955788|NCT00833469|EG000|Reported Event|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
10955789|NCT00833482|BG000|Baseline|Extensive Metabolizers (EM)|Participants with functional CYP2C19 alleles (extensive metabolizers, or EM).
10955790|NCT00833482|BG001|Baseline|Poor Metabolizers (PM)|Participants without a functional CYP2C19 allele (poor metabolizers, or PM).
10955791|NCT00833482|BG002|Baseline|Total|Total of all reporting groups
10955792|NCT00833482|FG000|Participant Flow|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
10955793|NCT00833482|FG001|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
10955794|NCT00833482|FG002|Participant Flow|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
10955795|NCT00833482|FG003|Participant Flow|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
10955796|NCT00833482|FG004|Participant Flow|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
10955797|NCT00833482|FG005|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
10955798|NCT00833482|OG000|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
10955799|NCT00833482|OG001|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
10955800|NCT00833482|OG000|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EMs received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
10955801|NCT00833482|OG000|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
10955802|NCT00833482|OG000|Outcome|Voriconazole, 200 BID|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
10955803|NCT00833482|OG001|Outcome|Atazanavir/Ritonavir, 300/100mg QD + Voriconazole, 200 mg BID|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
10955804|NCT00833482|OG001|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
10955805|NCT00833482|OG002|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
10955806|NCT00833482|OG003|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
10955807|NCT00833482|OG004|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
10955808|NCT00833482|OG005|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
10955809|NCT00833482|OG004|Outcome|Atazanavir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
10955810|NCT00833482|OG003|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
10955811|NCT00833482|OG004|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
10955812|NCT00833482|EG000|Reported Event|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
10955813|NCT00833482|EG001|Reported Event|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal
10955814|NCT00833482|EG002|Reported Event|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
10955815|NCT00833482|EG003|Reported Event|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
10955816|NCT00833482|EG004|Reported Event|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
10955817|NCT00833482|EG005|Reported Event|Atazanazvir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
10955818|NCT00833547|BG000|Baseline|Eszopiclone|3mg of eszopiclone at bedtime on 2 consecutive nights
10955819|NCT00833547|BG001|Baseline|Placebo|placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights
10955820|NCT00833547|BG002|Baseline|Total|Total of all reporting groups
10955821|NCT00833547|FG000|Participant Flow|Placebo|placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights
10955822|NCT00833547|FG001|Participant Flow|Eszopiclone|3mg of eszopiclone at bedtime for two consecutive nights
10955823|NCT00833547|OG000|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
10955824|NCT00833547|OG001|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
10955825|NCT00833547|EG000|Reported Event|Eszopiclone|3mg of eszopiclone on two consecutive nights
10955826|NCT00833547|EG001|Reported Event|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
10955827|NCT00833560|BG000|Baseline|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
10955828|NCT00833560|FG000|Participant Flow|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
11178803|NCT02051426|EG001|Reported Event|Placebo|corn starch
10955829|NCT00833560|OG000|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
10955830|NCT00833560|EG000|Reported Event|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
10955831|NCT00833638|BG000|Baseline|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
10955832|NCT00833638|BG001|Baseline|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
10955833|NCT00833638|BG002|Baseline|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
10955834|NCT00833638|BG003|Baseline|Total|Total of all reporting groups
10955835|NCT00833638|FG000|Participant Flow|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
10955836|NCT00833638|FG001|Participant Flow|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
10955837|NCT00833638|FG002|Participant Flow|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
10955838|NCT00833638|OG000|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
10955839|NCT00833638|OG001|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
10955840|NCT00833638|OG002|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
10955841|NCT00833638|OG000|Outcome|Placebo Double-blind|No drug during baseline period, placeob for 14 days, then will continue at 5 mg for 14 days.
10955842|NCT00833638|OG001|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
10955843|NCT00833638|OG000|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
10955844|NCT00833638|OG000|Outcome|Tadalafil 5 mg Double-blind|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
10955845|NCT00833638|OG001|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
10955846|NCT00833638|EG000|Reported Event|Tadalafil 2.5 mg|No drug during baseline period followed by tadalafil 2.5 mg for 14 days.
10955847|NCT00833638|EG001|Reported Event|Tadalafil 5 mg|No drug during baseline period followed by tadalafil 5 mg for 14 days.
10955848|NCT00833638|EG002|Reported Event|Placebo|No drug during baseline period followed by placebo for 14 days.
10955849|NCT00833638|EG003|Reported Event|Tadalafil 2.5 mg to Tadalafil 5 mg|Participants receiving tadalafil 5 mg in the open-label period after receiving tadalafil 2.5 mg in the double-blind period.
10955850|NCT00833638|EG004|Reported Event|Tadalafil 5 mg to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving tadalafil 5 mg in the double-blind period.
10955851|NCT00833638|EG005|Reported Event|Placebo to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving placebo in the double-blind period.
10955852|NCT00833690|BG000|Baseline|[A:]Placebo|Placebo to produce no urate elevation
10955853|NCT00833690|BG001|Baseline|[B:]Mild|Inosine to produce a mild urate elevation
10955854|NCT00833690|BG002|Baseline|[C.]Moderate|Inosine to produce a moderate urate elevation
10955855|NCT00833690|BG003|Baseline|Total|Total of all reporting groups
10955856|NCT00833690|FG000|Participant Flow|[A:]Placebo|Placebo to produce no urate elevation
10955857|NCT00833690|FG001|Participant Flow|[B:]Mild|Inosine to produce a mild urate elevation
10955858|NCT00833690|FG002|Participant Flow|[C.]Moderate|Inosine to produce a moderate urate elevation
10955859|NCT00833690|OG000|Outcome|[A:]Placebo|Placebo to produce no urate elevation
10955860|NCT00833690|OG001|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
10955861|NCT00833690|OG002|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
10955862|NCT00833690|EG000|Reported Event|[A:]Placebo|Placebo to produce no urate elevation
10955863|NCT00833690|EG001|Reported Event|[B:]Mild|Inosine to produce a mild urate elevation
10955864|NCT00833690|EG002|Reported Event|[C.]Moderate|Inosine to produce a moderate urate elevation
10963745|NCT00874029|BG000|Baseline|Halt Medical Acessa Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids had the Acessa Procedure using the Halt Medical Proprietary Acessa System. The Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical radiofrequency (RF) Handpiece. The Generator provides sinusoidally-varying voltage at 460 kilohertz (kHz) to drive a current through the tissue to be ablated. The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction. During these controlled ablations, the Generator produces an alternating current which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient's uterine fibroids and treat all of her fibroids, and just the fibroids.
10963746|NCT00874029|FG000|Participant Flow|Halt Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
10963747|NCT00874029|OG000|Outcome|Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment|"Of the 137 subjects enrolled and treated under this protocol, 124 (90.5%) were considered evaluable in terms of their 1) ability to provide a menstrual blood loss assessment, 2) lack of concomitant disease that affects the menstrual cycle, 3) baseline menstrual blood loss was within protocol inclusion limits."
10963748|NCT00874029|OG000|Outcome|Device Related Adverse Events|Device-related events are those that the investigator considered to be definitely, probably, or possibly related to the device.
10963749|NCT00874029|OG001|Outcome|Procedural|Procedure-related events are those that the investigator considered to be definitely, probably, or possibly related to the procedure, including those related to abdominal entry and anesthesia.
10963750|NCT00874029|OG000|Outcome|Surgical Reintervention 12 Months Post Treatment|The Per Protocol Set was the primary analysis set for surgical reintervention.
10955865|NCT00833703|BG000|Baseline|Placebo|0.2 mL/kg/day matching placebo solution once daily
10955866|NCT00833703|BG001|Baseline|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
10955867|NCT00833703|BG002|Baseline|Total|Total of all reporting groups
10955868|NCT00833703|FG000|Participant Flow|Placebo|0.2 mL/kg/day matching placebo solution once daily
10955869|NCT00833703|FG001|Participant Flow|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
10955870|NCT00833703|OG000|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
10955871|NCT00833703|OG001|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
10955872|NCT00833703|EG000|Reported Event|Placebo|0.2 mL/kg/day matching placebo solution once daily
10955873|NCT00833703|EG001|Reported Event|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
10955874|NCT00833755|BG000|Baseline|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
10955875|NCT00833755|BG001|Baseline|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
10955876|NCT00833755|BG002|Baseline|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
10955877|NCT00833755|BG003|Baseline|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
10955878|NCT00833755|BG004|Baseline|Total|Total of all reporting groups
10955879|NCT00833755|FG000|Participant Flow|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
10955880|NCT00833755|FG001|Participant Flow|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
10955881|NCT00833755|FG002|Participant Flow|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
10955882|NCT00833755|FG003|Participant Flow|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
10955883|NCT00833755|OG000|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
10955884|NCT00833755|OG001|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
10955885|NCT00833755|OG002|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
10955886|NCT00833755|OG003|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
10955887|NCT00833755|OG001|Outcome|Opioid - Placebo|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
10955888|NCT00833755|EG000|Reported Event|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
10955889|NCT00833755|EG001|Reported Event|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
10955890|NCT00833755|EG002|Reported Event|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
10955891|NCT00833755|EG003|Reported Event|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
10955892|NCT00833781|BG000|Baseline|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
10955893|NCT00833781|BG001|Baseline|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.~Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
10955894|NCT00833781|BG002|Baseline|Total|Total of all reporting groups
10955895|NCT00833781|FG000|Participant Flow|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
10955896|NCT00833781|FG001|Participant Flow|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.~Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
10955897|NCT00833781|OG000|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
10955898|NCT00833781|OG001|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
10955899|NCT00833781|EG000|Reported Event|mRNA Transfected DCs|
10955900|NCT00833794|BG000|Baseline|1 Tramadol Once A Day|
10955901|NCT00833794|BG001|Baseline|2 Placebo|
10955902|NCT00833794|BG002|Baseline|Total|Total of all reporting groups
10955903|NCT00833794|FG000|Participant Flow|1 Tramadol Once A Day|
10955904|NCT00833794|FG001|Participant Flow|2 Placebo|
10955905|NCT00833794|OG000|Outcome|1 Tramadol Once A Day|
10955906|NCT00833794|OG001|Outcome|2 Placebo|
10955907|NCT00833794|OG002|Outcome|Tramadol Once A Day 200 mg|
10955908|NCT00833794|OG003|Outcome|Tramadol Once A Day 300 mg|
10955909|NCT00833794|EG000|Reported Event|1 Tramadol Once A Day|
10955910|NCT00833794|EG001|Reported Event|2 Placebo|
10955911|NCT00833833|BG000|Baseline|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955912|NCT00833833|BG001|Baseline|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955913|NCT00833833|BG002|Baseline|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955914|NCT00833833|BG003|Baseline|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955915|NCT00833833|BG004|Baseline|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
10955916|NCT00833833|BG005|Baseline|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
10955917|NCT00833833|BG006|Baseline|Total|Total of all reporting groups
10955918|NCT00833833|FG000|Participant Flow|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955919|NCT00833833|FG001|Participant Flow|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955920|NCT00833833|FG002|Participant Flow|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955921|NCT00833833|FG003|Participant Flow|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955922|NCT00833833|FG004|Participant Flow|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
10955923|NCT00833833|FG005|Participant Flow|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
10955924|NCT00833833|OG000|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955925|NCT00833833|OG001|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
11178804|NCT02051452|BG000|Baseline|Methylphenidate|Patients will receive IV methylphenidate following general anesthesia
10955926|NCT00833833|OG002|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955927|NCT00833833|OG003|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955928|NCT00833833|OG000|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
10955929|NCT00833833|OG001|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
10955930|NCT00833833|OG001|Outcome|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
10955931|NCT00833833|OG002|Outcome|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
10955932|NCT00833833|OG003|Outcome|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
10955933|NCT00833833|OG001|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
10955934|NCT00833833|EG000|Reported Event|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
11178805|NCT02051452|BG001|Baseline|Placebo|Patients will receive IV saline following general anesthesia
11178806|NCT02051452|BG002|Baseline|Total|Total of all reporting groups
11178807|NCT02051452|FG000|Participant Flow|Methylphenidate|Patients will receive IV methylphenidate following general anesthesia
10955935|NCT00833833|EG001|Reported Event|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955936|NCT00833833|EG002|Reported Event|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955937|NCT00833833|EG003|Reported Event|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
10955938|NCT00833833|EG004|Reported Event|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
10955939|NCT00833833|EG005|Reported Event|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
10955940|NCT00833833|EG006|Reported Event|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
10955941|NCT00833833|EG007|Reported Event|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
10955942|NCT00833898|BG000|Baseline|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
10955943|NCT00833898|BG001|Baseline|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
10955944|NCT00833898|BG002|Baseline|Total|Total of all reporting groups
10955945|NCT00833898|FG000|Participant Flow|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
10955946|NCT00833898|FG001|Participant Flow|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
10955947|NCT00833898|OG000|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
10955948|NCT00833898|OG001|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
11178808|NCT02051452|FG001|Participant Flow|Placebo|Patients will receive IV saline following general anesthesia
10955949|NCT00833898|EG000|Reported Event|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
10955950|NCT00833898|EG001|Reported Event|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
10955951|NCT00833911|BG000|Baseline|300 mg Tramadol HCl OAD|
10955952|NCT00833911|FG000|Participant Flow|300 mg Tramadol HCl OAD|
10955953|NCT00833911|OG000|Outcome|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
10955954|NCT00833911|OG001|Outcome|6-months Safety|
10955955|NCT00833911|OG002|Outcome|12-months Safety|
10955956|NCT00833911|EG000|Reported Event|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
10955957|NCT00833911|EG001|Reported Event|6-months Safety|
10955958|NCT00833911|EG002|Reported Event|12-months Safety|
10955959|NCT00833924|BG000|Baseline|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
10955960|NCT00833924|FG000|Participant Flow|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
10955961|NCT00833924|OG000|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
10955962|NCT00833924|EG000|Reported Event|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
11178809|NCT02051452|OG000|Outcome|Methylphenidate|Patients will receive IV methylphenidate following general anesthesia
11178810|NCT02051452|OG001|Outcome|Placebo|Patients will receive IV saline following general anesthesia
11178811|NCT02051452|EG000|Reported Event|Methylphenidate|Patients will receive IV methylphenidate following general anesthesia
11178812|NCT02051452|EG001|Reported Event|Placebo|Patients will receive IV saline following general anesthesia
10955963|NCT00833976|BG000|Baseline|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
10955964|NCT00833976|FG000|Participant Flow|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
10955965|NCT00833976|OG000|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
10955966|NCT00833976|EG000|Reported Event|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
10955967|NCT00833989|BG000|Baseline|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955968|NCT00833989|BG001|Baseline|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955969|NCT00833989|BG002|Baseline|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955970|NCT00833989|BG003|Baseline|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
10955971|NCT00833989|BG004|Baseline|Total|Total of all reporting groups
10955972|NCT00833989|FG000|Participant Flow|Placebo|Eligible participants received 0.9% Sodium chloride as an intravenous (IV) infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955973|NCT00833989|FG001|Participant Flow|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 milligram per kilogram (mg/kg)of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955974|NCT00833989|FG002|Participant Flow|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955975|NCT00833989|FG003|Participant Flow|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
10955976|NCT00833989|OG000|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955977|NCT00833989|OG001|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955978|NCT00833989|OG002|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955979|NCT00833989|OG003|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
10955980|NCT00833989|OG000|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955981|NCT00833989|OG001|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955982|NCT00833989|OG002|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
10955983|NCT00833989|EG000|Reported Event|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955984|NCT00833989|EG001|Reported Event|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955985|NCT00833989|EG002|Reported Event|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
10955986|NCT00833989|EG003|Reported Event|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
10955987|NCT00834041|BG000|Baseline|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
10955988|NCT00834041|BG001|Baseline|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
10955989|NCT00834041|BG002|Baseline|Total|Total of all reporting groups
10955990|NCT00834041|FG000|Participant Flow|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
10955991|NCT00834041|FG001|Participant Flow|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
10955992|NCT00834041|OG000|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
10955993|NCT00834041|OG001|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
10955994|NCT00834041|EG000|Reported Event|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
10955995|NCT00834041|EG001|Reported Event|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
10955996|NCT00834080|BG000|Baseline|VIVITROL, 380mg|
10955997|NCT00834080|FG000|Participant Flow|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
10955998|NCT00834080|OG000|Outcome|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
10955999|NCT00834080|EG000|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
10956000|NCT00834106|BG000|Baseline|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
10956001|NCT00834106|BG001|Baseline|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
10956002|NCT00834106|BG002|Baseline|Total|Total of all reporting groups
10956003|NCT00834106|FG000|Participant Flow|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
10956004|NCT00834106|FG001|Participant Flow|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
10956005|NCT00834106|OG000|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
10956006|NCT00834106|OG001|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
10956007|NCT00834106|EG000|Reported Event|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
10956008|NCT00834106|EG001|Reported Event|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
10956009|NCT00834171|BG000|Baseline|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
10956010|NCT00834171|BG001|Baseline|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
10956011|NCT00834171|BG002|Baseline|Total|Total of all reporting groups
10956012|NCT00834171|FG000|Participant Flow|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
10956013|NCT00834171|FG001|Participant Flow|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
10956014|NCT00834171|OG000|Outcome|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
10956015|NCT00834171|OG001|Outcome|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
10956016|NCT00834171|EG000|Reported Event|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
10956017|NCT00834171|EG001|Reported Event|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
10956018|NCT00834210|BG000|Baseline|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
10956019|NCT00834210|BG001|Baseline|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
10956020|NCT00834210|BG002|Baseline|Total|Total of all reporting groups
10956021|NCT00834210|FG000|Participant Flow|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
10956022|NCT00834210|FG001|Participant Flow|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
10956023|NCT00834210|OG000|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
10956024|NCT00834210|OG001|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
10956025|NCT00834210|EG000|Reported Event|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
10956026|NCT00834210|EG001|Reported Event|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
10956027|NCT00834236|BG000|Baseline|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
10956028|NCT00834236|BG001|Baseline|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
10956029|NCT00834236|BG002|Baseline|Total|Total of all reporting groups
10956030|NCT00834236|FG000|Participant Flow|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
10956031|NCT00834236|FG001|Participant Flow|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
10956032|NCT00834236|OG000|Outcome|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
10956033|NCT00834236|OG001|Outcome|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
10956034|NCT00834236|EG000|Reported Event|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
10956035|NCT00834236|EG001|Reported Event|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
10956036|NCT00834288|BG000|Baseline|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
10956037|NCT00834288|BG001|Baseline|Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First|1 x 50 mg Tramadol HCl IR (Ultram®) Tablet 6-Hourly reference product dosed in first period followed by Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II). IR = Immediate Release.
10956038|NCT00834288|BG002|Baseline|Total|Total of all reporting groups
10956039|NCT00834288|FG000|Participant Flow|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
10956040|NCT00834288|FG001|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 x 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
10956041|NCT00834288|OG000|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
10956042|NCT00834288|OG001|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
10956043|NCT00834288|EG000|Reported Event|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
10956044|NCT00834288|EG001|Reported Event|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
10956045|NCT00834366|BG000|Baseline|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
10956046|NCT00834366|BG001|Baseline|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
10956047|NCT00834366|BG002|Baseline|Total|Total of all reporting groups
10956048|NCT00834366|FG000|Participant Flow|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
10956049|NCT00834366|FG001|Participant Flow|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
10956050|NCT00834366|OG000|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
10956051|NCT00834366|OG001|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
10956052|NCT00834366|EG000|Reported Event|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
10956053|NCT00834366|EG001|Reported Event|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
10956054|NCT00834483|BG000|Baseline|Treatment Group|Knotless suture for wound closure
10956055|NCT00834483|BG001|Baseline|Control Group|Layered traditional wound closure (monocryl)
10956056|NCT00834483|BG002|Baseline|Total|Total of all reporting groups
10956057|NCT00834483|FG000|Participant Flow|Treatment Group|Knotless suture for wound closure
10956058|NCT00834483|FG001|Participant Flow|Control Group|Layered traditional wound closure (monocryl)
10956059|NCT00834483|OG000|Outcome|Treatment Group|Knotless suture for wound closure
10956060|NCT00834483|OG001|Outcome|Control Group|Layered traditional wound closure (monocryl)
10956061|NCT00834483|EG000|Reported Event|Treatment Group|Knotless suture for wound closure
10956062|NCT00834483|EG001|Reported Event|Control Group|Layered traditional wound closure (monocryl)
10956063|NCT00834626|BG000|Baseline|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
10956064|NCT00834626|FG000|Participant Flow|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
10956065|NCT00834626|OG000|Outcome|Percentage of Participants Not Requiring Insulin|Percentage of participants not requiring Insulin assessed at 1 year post-surgery
10956066|NCT00834626|OG000|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
10956067|NCT00834626|EG000|Reported Event|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
10956068|NCT00834652|BG000|Baseline|Sertraline Plus Metformin|"Participants will receive sertraline and metformin for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day~Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily"
10956069|NCT00834652|BG001|Baseline|Sertraline Plus Placebo|"Participants will receive sertraline and placebo for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day"
10956070|NCT00834652|BG002|Baseline|Total|Total of all reporting groups
10956071|NCT00834652|FG000|Participant Flow|Sertraline Plus Metformin|"Participants will receive sertraline and metformin for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day~Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily"
10956072|NCT00834652|FG001|Participant Flow|Sertraline Plus Placebo|"Participants will receive sertraline and placebo for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day"
10956073|NCT00834652|OG000|Outcome|Sertraline Plus Metformin|"Participants will receive sertraline and metformin for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day~Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily"
10956074|NCT00834652|OG001|Outcome|Sertraline Plus Placebo|"Participants will receive sertraline and placebo for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day"
10956075|NCT00834652|EG000|Reported Event|Sertraline Plus Metformin|
10956076|NCT00834652|EG001|Reported Event|Sertraline Plus Placebo|
10956077|NCT00834678|BG000|Baseline|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 - 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
10956078|NCT00834678|FG000|Participant Flow|Bendamustine and Erlotinib|Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.
10956079|NCT00834678|OG000|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.~Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
10956080|NCT00834678|OG000|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 - 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
10956081|NCT00834678|OG000|Outcome|Bendamustine and Erlotinib|Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.
10956082|NCT00834678|EG000|Reported Event|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 - 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
10956083|NCT00834808|BG000|Baseline|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956084|NCT00834808|BG001|Baseline|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956085|NCT00834808|BG002|Baseline|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956086|NCT00834808|BG003|Baseline|Total|Total of all reporting groups
10956087|NCT00834808|FG000|Participant Flow|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956088|NCT00834808|FG001|Participant Flow|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956089|NCT00834808|FG002|Participant Flow|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956090|NCT00834808|OG000|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956091|NCT00834808|OG001|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956092|NCT00834808|OG002|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956093|NCT00834808|EG000|Reported Event|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956094|NCT00834808|EG001|Reported Event|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956095|NCT00834808|EG002|Reported Event|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
10956096|NCT00834834|BG000|Baseline|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
10956097|NCT00834834|BG001|Baseline|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
10956098|NCT00834834|BG002|Baseline|Total|Total of all reporting groups
10956099|NCT00834834|FG000|Participant Flow|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
10956100|NCT00834834|FG001|Participant Flow|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
10956101|NCT00834834|OG000|Outcome|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
10956102|NCT00834834|OG001|Outcome|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
10956103|NCT00834834|EG000|Reported Event|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
10956104|NCT00834834|EG001|Reported Event|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
10956105|NCT00834886|BG000|Baseline|Melatonin and Light Therapy|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
10956106|NCT00834886|BG001|Baseline|Melatonin and Placebo Light|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
10956107|NCT00834886|BG002|Baseline|Placebo Melatonin and Light Therapy|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
10956108|NCT00834886|BG003|Baseline|Placebo Melatonin and Placebo Light|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
10956109|NCT00834886|BG004|Baseline|Total|Total of all reporting groups
10956110|NCT00834886|FG000|Participant Flow|Combination|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
10956111|NCT00834886|FG001|Participant Flow|Melatonin|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
10956112|NCT00834886|FG002|Participant Flow|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
10956113|NCT00834886|FG003|Participant Flow|Placebo|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
10956114|NCT00834886|OG000|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
10956115|NCT00834886|OG001|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
11357666|NCT03750955|OG001|Outcome|Oral Hygiene Maintenance|"Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.~Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily."
10956116|NCT00834886|OG002|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
10956117|NCT00834886|OG003|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
10956118|NCT00834886|EG000|Reported Event|Combination|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
10956119|NCT00834886|EG001|Reported Event|Melatonin|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
10956120|NCT00834886|EG002|Reported Event|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
10956121|NCT00834886|EG003|Reported Event|Placebo|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
10956122|NCT00834899|BG000|Baseline|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
10956123|NCT00834899|BG001|Baseline|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
10956124|NCT00834899|BG002|Baseline|Total|Total of all reporting groups
10956125|NCT00834899|FG000|Participant Flow|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
10956126|NCT00834899|FG001|Participant Flow|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
10956127|NCT00834899|OG000|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
10956128|NCT00834899|OG001|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
10956129|NCT00834899|EG000|Reported Event|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
10956130|NCT00834899|EG001|Reported Event|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
10956131|NCT00834912|BG000|Baseline|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
10956132|NCT00834912|BG001|Baseline|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
10956133|NCT00834912|BG002|Baseline|Confab Fed / Confab Fasting / Trillium Fasting|Confab fed / Confab fasting / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
10956134|NCT00834912|BG003|Baseline|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
10956135|NCT00834912|BG004|Baseline|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
10956136|NCT00834912|BG005|Baseline|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
10956137|NCT00834912|BG006|Baseline|Total|Total of all reporting groups
10956138|NCT00834912|FG000|Participant Flow|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
10956139|NCT00834912|FG001|Participant Flow|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
10956140|NCT00834912|FG002|Participant Flow|Confab Fed / Confab Fasting / Trillium Fasting|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
10956141|NCT00834912|FG003|Participant Flow|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
10956142|NCT00834912|FG004|Participant Flow|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
11234401|NCT02434939|OG001|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
10956143|NCT00834912|FG005|Participant Flow|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
10956144|NCT00834912|OG000|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
10956145|NCT00834912|OG001|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
10956146|NCT00834912|OG002|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
10956147|NCT00834912|EG000|Reported Event|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
10956148|NCT00834912|EG001|Reported Event|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
10956149|NCT00834912|EG002|Reported Event|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
10956150|NCT00835003|BG000|Baseline|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
10956151|NCT00835003|BG001|Baseline|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
10956152|NCT00835003|BG002|Baseline|Total|Total of all reporting groups
10956153|NCT00835003|FG000|Participant Flow|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
10956154|NCT00835003|FG001|Participant Flow|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
10956155|NCT00835003|OG000|Outcome|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
10956156|NCT00835003|OG001|Outcome|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
10956157|NCT00835003|EG000|Reported Event|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
10956158|NCT00835003|EG001|Reported Event|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
10956159|NCT00835068|BG000|Baseline|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
10956160|NCT00835068|BG001|Baseline|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
10956161|NCT00835068|BG002|Baseline|Total|Total of all reporting groups
10956162|NCT00835068|FG000|Participant Flow|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
10956163|NCT00835068|FG001|Participant Flow|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
10956164|NCT00835068|OG000|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
10956165|NCT00835068|OG001|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
10956166|NCT00835068|EG000|Reported Event|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
10956167|NCT00835068|EG001|Reported Event|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
10956168|NCT00835120|BG000|Baseline|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
10956169|NCT00835120|FG000|Participant Flow|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
10956170|NCT00835120|OG000|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
10956171|NCT00835120|EG000|Reported Event|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
10956172|NCT00835159|BG000|Baseline|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
10956173|NCT00835159|BG001|Baseline|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
10956174|NCT00835159|BG002|Baseline|Total|Total of all reporting groups
10956175|NCT00835159|FG000|Participant Flow|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
10956176|NCT00835159|FG001|Participant Flow|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
10956177|NCT00835159|OG000|Outcome|Rivastigmine Patch|Eligible patients received a rivastigmine 5-cm2 transdermal patch
10956178|NCT00835159|OG001|Outcome|Placebo Patch|Eligible patients received a placebo patch
10956179|NCT00835159|EG000|Reported Event|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
10956180|NCT00835159|EG001|Reported Event|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
10956181|NCT00835185|BG000|Baseline|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
10963751|NCT00874029|OG000|Outcome|Change in Uterine Volume|Uterine volume assessment 12 months post treatment via contrast enhanced MRI
10963752|NCT00874029|OG001|Outcome|Change in Fibroid Volume|Fibroid volume assessment 12 months post treatment via contrast enhanced MRI
10963753|NCT00874029|OG000|Outcome|Full Analysis Set - Symptom Severity|All treated subjects who met all inclusion and exclusion criteria and who completed the Symptom Severity Questionnaire at Baseline and 12 months.
10956182|NCT00835185|FG000|Participant Flow|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 milligrams (mg) IMC-11F8 intravenous (IV) infusion over 50 minutes~85 milligrams per meter square (mg/m²) oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent or until other criteria for treatment discontinuation were met."
10956183|NCT00835185|OG000|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
10956184|NCT00835185|OG000|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
10956185|NCT00835185|EG000|Reported Event|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
10956186|NCT00835198|BG000|Baseline|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
10956187|NCT00835198|BG001|Baseline|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
10956188|NCT00835198|BG002|Baseline|Total|Total of all reporting groups
10956189|NCT00835198|FG000|Participant Flow|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
10956190|NCT00835198|FG001|Participant Flow|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
10956191|NCT00835198|OG000|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
10956192|NCT00835198|OG001|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
10956193|NCT00835198|EG000|Reported Event|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
10956194|NCT00835198|EG001|Reported Event|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
10956195|NCT00835224|BG000|Baseline|All Participants|All participants were studied on three laboratory visits and underwent seated blood pressure assessment before and after administration of Midodrine, L-NAME or placebo, which were given in random order.
10956196|NCT00835224|FG000|Participant Flow|All Participants|All Participants visited the laboratory on 3 occasions for a 4-5 hour observation of blood pressure following administration of a non-selective inhibitor of nitric oxide synthase (L-NAME) an alpha-agonist (midodrine) or placebo. The interventions were administered in random order on separate laboratory visits.
10956197|NCT00835224|OG000|Outcome|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
10956198|NCT00835224|OG001|Outcome|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
10956199|NCT00835224|OG002|Outcome|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
10956200|NCT00835224|OG003|Outcome|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
10956201|NCT00835224|OG004|Outcome|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
10956202|NCT00835224|OG005|Outcome|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
10956203|NCT00835224|EG000|Reported Event|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
10956204|NCT00835224|EG001|Reported Event|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
10956205|NCT00835224|EG002|Reported Event|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
10956206|NCT00835224|EG003|Reported Event|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
10956207|NCT00835224|EG004|Reported Event|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
10956208|NCT00835224|EG005|Reported Event|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
10956209|NCT00835237|BG000|Baseline|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
10956210|NCT00835237|BG001|Baseline|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
10956211|NCT00835237|BG002|Baseline|Total|Total of all reporting groups
10956212|NCT00835237|FG000|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
10956213|NCT00835237|FG001|Participant Flow|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
10956214|NCT00835237|OG000|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
10956215|NCT00835237|OG001|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
10956216|NCT00835237|EG000|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
10956217|NCT00835237|EG001|Reported Event|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
10956218|NCT00835341|BG000|Baseline|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
10956219|NCT00835341|BG001|Baseline|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
10956220|NCT00835341|BG002|Baseline|Total|Total of all reporting groups
10956221|NCT00835341|FG000|Participant Flow|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
10956222|NCT00835341|FG001|Participant Flow|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
10956223|NCT00835341|OG000|Outcome|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
10956224|NCT00835341|OG001|Outcome|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
10956225|NCT00835341|EG000|Reported Event|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
10956226|NCT00835341|EG001|Reported Event|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
10956227|NCT00835380|BG000|Baseline|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
10956228|NCT00835380|FG000|Participant Flow|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
10956229|NCT00835380|OG000|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
10956230|NCT00835380|EG000|Reported Event|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
10956231|NCT00835510|BG000|Baseline|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
10956232|NCT00835510|BG001|Baseline|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
10956233|NCT00835510|BG002|Baseline|Vehicle|Butenafine vehicle applied for 7 days
10956234|NCT00835510|BG003|Baseline|Total|Total of all reporting groups
10956235|NCT00835510|FG000|Participant Flow|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
10956236|NCT00835510|FG001|Participant Flow|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
10956237|NCT00835510|FG002|Participant Flow|Vehicle|Butenafine vehicle applied for 7 days
10956238|NCT00835510|OG000|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
10956239|NCT00835510|OG001|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
10956240|NCT00835510|OG002|Outcome|Vehicle|Butenafine vehicle applied for 7 days
10956241|NCT00835510|EG000|Reported Event|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
10956242|NCT00835510|EG001|Reported Event|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
10956243|NCT00835510|EG002|Reported Event|Vehicle|Butenafine vehicle applied for 7 days
10956244|NCT00835731|BG000|Baseline|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
10956245|NCT00835731|BG001|Baseline|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
10956246|NCT00835731|BG002|Baseline|Total|Total of all reporting groups
10956247|NCT00835731|FG000|Participant Flow|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
10956248|NCT00835731|FG001|Participant Flow|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
10956249|NCT00835731|OG000|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
10956250|NCT00835731|OG001|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
10956251|NCT00835731|EG000|Reported Event|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
10956252|NCT00835731|EG001|Reported Event|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
10956253|NCT00835770|BG000|Baseline|BG00012 240 mg BID|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.
10956254|NCT00835770|BG001|Baseline|BG00012 240 mg TID|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
10956255|NCT00835770|BG002|Baseline|Total|Total of all reporting groups
10956256|NCT00835770|FG000|Participant Flow|BG00012 240 mg BID|Participants received BG00012 240 milligram (mg), 2 capsules (120 mg each) orally, twice a day (BID) and 2 matching placebo capsules once a day (QD) for up to 8 years.
11357667|NCT03750955|EG000|Reported Event|Plaque Induced Gingivitis|Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.
10956257|NCT00835770|FG001|Participant Flow|BG00012 240 mg TID|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, three times a day (TID) for up to 8 years.
10956258|NCT00835770|OG000|Outcome|BG00012 240 mg BID|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.
10956259|NCT00835770|OG001|Outcome|BG00012 240 mg TID|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
10956260|NCT00835770|OG000|Outcome|BG00012 240 mg BID (Prior BG00012 240 mg BID)|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
10956261|NCT00835770|OG001|Outcome|BG00012 240 mg TID (Prior BG00012 240 mg TID)|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
10956262|NCT00835770|OG002|Outcome|BG00012 240 mg BID (Prior BG00012 Matched Placebo)|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
10956263|NCT00835770|OG003|Outcome|BG00012 240 mg TID (Prior BG00012 Matched Placebo)|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
10956264|NCT00835770|OG004|Outcome|BG00012 240 mg BID (Prior Glatiramer Acetate [GA])|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
10956265|NCT00835770|OG005|Outcome|BG00012 240 mg TID (Prior Glatiramer Acetate [GA])|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
10956266|NCT00835770|EG000|Reported Event|BG00012 240 mg BID|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.
10956267|NCT00835770|EG001|Reported Event|BG00012 240 mg TID|Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
10956268|NCT00835861|BG000|Baseline|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone.
10956269|NCT00835861|BG001|Baseline|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
10956270|NCT00835861|BG002|Baseline|Total|Total of all reporting groups
10956271|NCT00835861|FG000|Participant Flow|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone
10956272|NCT00835861|FG001|Participant Flow|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and neutral protamine Hagedorn (NPH) insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
10956273|NCT00835861|OG000|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
10956274|NCT00835861|OG001|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
10956275|NCT00835861|EG000|Reported Event|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
10956276|NCT00835861|EG001|Reported Event|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
10956277|NCT00835900|BG000|Baseline|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
10956278|NCT00835900|BG001|Baseline|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
10956279|NCT00835900|BG002|Baseline|Total|Total of all reporting groups
10956280|NCT00835900|FG000|Participant Flow|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
10956281|NCT00835900|FG001|Participant Flow|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
10956282|NCT00835900|OG000|Outcome|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
10956283|NCT00835900|OG001|Outcome|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
10956284|NCT00835900|EG000|Reported Event|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
10956285|NCT00835900|EG001|Reported Event|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
10956286|NCT00835926|BG000|Baseline|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
10956287|NCT00835926|BG001|Baseline|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
10956288|NCT00835926|BG002|Baseline|Total|Total of all reporting groups
10956289|NCT00835926|FG000|Participant Flow|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
10956290|NCT00835926|FG001|Participant Flow|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
10956291|NCT00835926|OG000|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
10956292|NCT00835926|OG001|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
10956293|NCT00835926|EG000|Reported Event|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
10956294|NCT00835926|EG001|Reported Event|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
10956295|NCT00835978|BG000|Baseline|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
10956296|NCT00835978|BG001|Baseline|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
10956297|NCT00835978|BG002|Baseline|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
10956298|NCT00835978|BG003|Baseline|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
10956299|NCT00835978|BG004|Baseline|Total|Total of all reporting groups
10956300|NCT00835978|FG000|Participant Flow|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
10956301|NCT00835978|FG001|Participant Flow|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
10956302|NCT00835978|FG002|Participant Flow|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
10956303|NCT00835978|FG003|Participant Flow|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
10956304|NCT00835978|OG000|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
10956305|NCT00835978|OG001|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
10956306|NCT00835978|OG002|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
10956307|NCT00835978|OG003|Outcome|All Participants|All enrolled participants (randomized and non-randomized)
10956308|NCT00835978|OG000|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
10956309|NCT00835978|OG000|Outcome|Active Titration Arm (FA Population)|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
10956310|NCT00835978|OG001|Outcome|Placebo Titration Arm (FA Population)|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
10956311|NCT00835978|OG002|Outcome|Non-randomized Arm (SA Population)|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
10956312|NCT00835978|OG001|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
10956313|NCT00835978|EG000|Reported Event|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
11178813|NCT02051595|BG000|Baseline|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
10956314|NCT00835978|EG001|Reported Event|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
10956315|NCT00835978|EG002|Reported Event|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
10956316|NCT00835978|EG003|Reported Event|Discontinued Prior to Randomization|Participants who were discontinued prior to randomization to either treatment or non-randomization arms.
10956317|NCT00836017|BG000|Baseline|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
10956318|NCT00836017|FG000|Participant Flow|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
10956319|NCT00836017|OG000|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
10956320|NCT00836017|EG000|Reported Event|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
10956321|NCT00836095|BG000|Baseline|Supreme LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.~Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant."
10956322|NCT00836095|BG001|Baseline|Proseal LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.~Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
10956323|NCT00836095|BG002|Baseline|Total|Total of all reporting groups
10956324|NCT00836095|FG000|Participant Flow|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
10963754|NCT00874029|OG001|Outcome|Full Analysis Set - Health Related Quality of Life (HRQL)|All treated subjects who met all inclusion and exclusion Criteria and who completed the HRQL questionnaire at both baseline and 12 months.
11357668|NCT03750955|EG001|Reported Event|Oral Hygiene Maintenance|Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.
11178814|NCT02051595|FG000|Participant Flow|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
11178815|NCT02051595|OG000|Outcome|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
11178816|NCT02051595|EG000|Reported Event|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
11178817|NCT02051686|BG000|Baseline|Tranexamic Acid|Patients in the intervention group were administered a 10mg/kg preoperative dose of tranexamic acid within 30 minutes prior to surgery followed by a 10mg/kg infusion over a 4hr period during surgery.
10956325|NCT00836095|FG001|Participant Flow|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
10956326|NCT00836095|OG000|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
10956327|NCT00836095|OG001|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
10956328|NCT00836095|EG000|Reported Event|Supreme LMA|"Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.~Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant"
11178818|NCT02051686|BG001|Baseline|Placebo|Patients in the control group received an equal volume and rate of normal saline.
11178819|NCT02051686|BG002|Baseline|Total|Total of all reporting groups
11178820|NCT02051686|FG000|Participant Flow|Tranexamic Acid|"Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.~Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours."
11178821|NCT02051686|FG001|Participant Flow|Placebo|"The control group will receive a similar volume load of normal saline and maintenance doses.~Placebo: The control group will receive a similar volume load of normal saline and maintenance doses."
11178822|NCT02051686|OG000|Outcome|Tranexamic Acid|"Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.~Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours."
11178823|NCT02051686|OG001|Outcome|Placebo|"The control group will receive a similar volume load of normal saline and maintenance doses.~Placebo: The control group will receive a similar volume load of normal saline and maintenance doses."
11178824|NCT02051686|EG000|Reported Event|Tranexamic Acid|"Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.~Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours."
11178825|NCT02051686|EG001|Reported Event|Placebo|"The control group will receive a similar volume load of normal saline and maintenance doses.~Placebo: The control group will receive a similar volume load of normal saline and maintenance doses."
11178826|NCT02051764|BG000|Baseline|Cognitively Impaired|Clinically-diagnosed AD, MCI, and other dementing disorders (ODD) from the flortaucipir PET scan arm
11178827|NCT02051764|BG001|Baseline|Healthy Volunteers|Healthy Volunteers from the flortaucipir PET scan arm
11178828|NCT02051764|BG002|Baseline|Total|Total of all reporting groups
11178829|NCT02051764|FG000|Participant Flow|Cognitively Impaired|Clinically-diagnosed Alzheimer's disease (AD), mild cognitive impairment (MCI), and other dementing disorders (ODD) from the flortaucipir PET scan arm
11178830|NCT02051764|FG001|Participant Flow|Healthy Volunteers|Male or female subjects ≥50 years of age without cognitive impairment from the flortaucipir PET scan arm
11178831|NCT02051764|OG000|Outcome|Cognitively Impaired|Clinically-diagnosed AD, MCI, and other dementing disorders (ODD) from the flortaucipir PET scan arm
11178832|NCT02051764|OG001|Outcome|Healthy Volunteers|Male or female subjects ≥50 years of age without cognitive impairment from the flortaucipir PET scan arm
11178833|NCT02051764|EG000|Reported Event|Cognitively Impaired|Clinically-diagnosed Alzheimer's disease (AD), mild cognitive impairment (MCI), and other dementing disorders (ODD) from the flortaucipir PET scan arm
11178834|NCT02051764|EG001|Reported Event|Healthy Volunteers|Male or female subjects ≥50 years of age without cognitive impairment from the flortaucipir PET scan arm
11178835|NCT02051790|BG000|Baseline|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
11178836|NCT02051790|FG000|Participant Flow|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
10956329|NCT00836095|EG001|Reported Event|Proseal LMA|"Proseal is a multiple use, variant of the laryngeal mask airway.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.~Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
10956330|NCT00836186|BG000|Baseline|Radiation Therapy|"Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.~Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy."
10956331|NCT00836186|FG000|Participant Flow|Radiation Therapy|"Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.~Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 centigray (cGy) per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy."
10956332|NCT00836186|OG000|Outcome|Radiation Therapy|"Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.~Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy."
10956333|NCT00836186|OG000|Outcome|Radiation Therapy|"Women with non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.~Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy."
10956334|NCT00836186|EG000|Reported Event|Radiation Therapy|"Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.~Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy."
10956335|NCT00836277|BG000|Baseline|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
10956336|NCT00836277|FG000|Participant Flow|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
10956337|NCT00836277|OG000|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
10956338|NCT00836277|EG000|Reported Event|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
10956339|NCT00836342|BG000|Baseline|Previous History of SCC|Participants had previous history of squamous cell carcinoma
10956340|NCT00836342|BG001|Baseline|Previous History of BCC|Participants had previous history of basal cell carcinoma
10956341|NCT00836342|BG002|Baseline|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
10956342|NCT00836342|BG003|Baseline|Total|Total of all reporting groups
10956343|NCT00836342|FG000|Participant Flow|Previous History of SCC|Participants had previous history of squamous cell carcinoma
10956344|NCT00836342|FG001|Participant Flow|Previous History of BCC|Participants had previous history of basal cell carcinoma
10956345|NCT00836342|FG002|Participant Flow|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
10956346|NCT00836342|OG000|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
10956347|NCT00836342|OG001|Outcome|Control Group|Participants had no previous history or squamous cell carcinoma or basal cell carcinoma
10956348|NCT00836342|OG001|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
10956349|NCT00836342|OG000|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
10956350|NCT00836342|OG001|Outcome|Control Group|Participants had no history of previous squamous cell carcinoma or basal cell carcinoma
10956351|NCT00836342|EG000|Reported Event|Previous History of SCC|Participants had previous history of squamous cell carcinoma
10956352|NCT00836342|EG001|Reported Event|Previous History of BCC|Participants had previous history of basal cell carcinoma
10956353|NCT00836342|EG002|Reported Event|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
10956354|NCT00836407|BG000|Baseline|Arm 1: Ipilimumab Alone|Ipilimumab alone
10956355|NCT00836407|BG001|Baseline|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
10956356|NCT00836407|BG002|Baseline|Total|Total of all reporting groups
10956357|NCT00836407|FG000|Participant Flow|Arm 1: Ipilimumab Alone|Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.
10956358|NCT00836407|FG001|Participant Flow|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|"Drug: Ipilimumab Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.~Biological/Vaccine: Pancreatic Cancer Vaccine The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks."
10956359|NCT00836407|OG000|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
10956360|NCT00836407|OG001|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
10956361|NCT00836407|EG000|Reported Event|Arm 1: Ipilimumab Alone|Ipilimumab alone
10956362|NCT00836407|EG001|Reported Event|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
10956363|NCT00836433|BG000|Baseline|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956364|NCT00836433|BG001|Baseline|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956365|NCT00836433|BG002|Baseline|Total|Total of all reporting groups
10956366|NCT00836433|FG000|Participant Flow|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956367|NCT00836433|FG001|Participant Flow|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956368|NCT00836433|OG000|Outcome|FALLS|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
11234402|NCT02434939|OG001|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes . Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
11357669|NCT03750955|EG002|Reported Event|Hygiene Phase|Adverse Events that occurred during the Hygiene Phase of 2 weeks (the period between enrollment and the start of the Gingivitis Induction Phase of 2 weeks).
10956369|NCT00836433|OG001|Outcome|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956370|NCT00836433|OG000|Outcome|FALLS Only|"Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956371|NCT00836433|OG001|Outcome|CONNECT and FALLS|"CONNECT intervention on relationship-building and communication. Includes 2 in-class session, group mapping, individual relationship mapping, coaching sessions.~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956372|NCT00836433|EG000|Reported Event|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956373|NCT00836433|EG001|Reported Event|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
10956374|NCT00836498|BG000|Baseline|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956375|NCT00836498|BG001|Baseline|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956376|NCT00836498|BG002|Baseline|Total|Total of all reporting groups
10956377|NCT00836498|FG000|Participant Flow|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956378|NCT00836498|FG001|Participant Flow|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956379|NCT00836498|OG000|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956380|NCT00836498|OG001|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956381|NCT00836498|OG000|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956382|NCT00836498|EG000|Reported Event|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956383|NCT00836498|EG001|Reported Event|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
10956384|NCT00836589|BG000|Baseline|Data Collection Group|ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
10956385|NCT00836589|FG000|Participant Flow|Data Collection Group|ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
10956386|NCT00836589|OG000|Outcome|Data Collection Group|ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
10956387|NCT00836589|OG000|Outcome|Linox Lead System|Linox leads including S, SD, T, and TD models, Linox smart leads including smart S, smart SD, and smart TD models.
10956388|NCT00836589|OG000|Outcome|Linox S|
10956389|NCT00836589|OG001|Outcome|Linox SD|
10956390|NCT00836589|OG002|Outcome|Linox T|
10956391|NCT00836589|OG003|Outcome|Linox TD|
10956392|NCT00836589|OG004|Outcome|Linox Smart S|
10956393|NCT00836589|OG005|Outcome|Linox Smart SD|
10956394|NCT00836589|OG006|Outcome|Linox Smart TD|
10956395|NCT00836589|EG000|Reported Event|Data Collection Group|ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
10956396|NCT00836641|BG000|Baseline|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
10956397|NCT00836641|BG001|Baseline|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
10956398|NCT00836641|BG002|Baseline|Total|Total of all reporting groups
10956399|NCT00836641|FG000|Participant Flow|Group A: Sequential Pneumococcal Immunzation (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
11178837|NCT02051790|OG000|Outcome|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
10956400|NCT00836641|FG001|Participant Flow|Group B: Sequential Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
10956401|NCT00836641|OG000|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
10956402|NCT00836641|OG001|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
10956403|NCT00836641|EG000|Reported Event|Overall Study Population|the whole study population was observed for adverse events.
10956404|NCT00836693|BG000|Baseline|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
10956405|NCT00836693|BG001|Baseline|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
10956406|NCT00836693|BG002|Baseline|Total|Total of all reporting groups
10956407|NCT00836693|FG000|Participant Flow|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
10956408|NCT00836693|FG001|Participant Flow|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
10956409|NCT00836693|OG000|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
10956410|NCT00836693|OG001|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
10956411|NCT00836693|EG000|Reported Event|Tadalafil|Tadalafil 5 milligrams administered orally once a day over 12 weeks. Dosing started at 5 mg tadalafil daily (or matching placebo) and could be down-titrated to 2.5 mg tadalafil daily (or matching placebo) based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
10956412|NCT00836693|EG001|Reported Event|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration.
10956413|NCT00836719|BG000|Baseline|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
10956414|NCT00836719|FG000|Participant Flow|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
10956415|NCT00836719|OG000|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
10956416|NCT00836719|EG000|Reported Event|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
10956417|NCT00836745|BG000|Baseline|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
10956418|NCT00836745|FG000|Participant Flow|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
10963755|NCT00874029|OG000|Outcome|Full Analysis Set - Month 12 Health Status Change|All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.
10956419|NCT00836745|OG000|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
10956420|NCT00836745|EG000|Reported Event|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
10956421|NCT00836758|BG000|Baseline|CPAP Device|"Breathing event detection (AED) by the continuous positive airway pressure (CPAP) device will be compared to breathing event detection by a simultaneous PSG (manual PSG scoring).~Analysis with AED and manual PSG scoring: The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring."
10956422|NCT00836758|FG000|Participant Flow|All Participants|Data was collected from participants that participated in a multi-center, randomized, double-blind trial comparing three modes of positive pressure delivery who had overnight PSGs.
10956423|NCT00836758|OG000|Outcome|Manual PSG Scoring|The PSGs were manually scored with the aid of computer software by a PSG technologist at a central scoring facility. The technologist was blinded to the event signal during manual scoring (the event signal was not visible in the montages used for scoring). Sleep staging and respiratory events were scored using 2007 American Academy of Sleep Medicine (AASM) guidelines. The scoring of a hypopnea required that the event be associated with a ≥ 4% oxygen desaturation.
10956424|NCT00836758|OG001|Outcome|Automatic Event Detection|The AED algorithm used the following criteria to identify respiratory events. An apnea was detected when there was an 80% or greater reduction in the airflow for 10 sec or longer in comparison with the average airflow over the previous 2 minutes. A hypopnea was detected when there was a device estimated 40% reduction in airflow for ≥ 10 sec but < 60 sec compared with the average airflow over the previous 2 minutes. The hypopnea detection algorithm required the presence of two recovery breaths that nominally were at least 75% to 80% of the baseline airflow. The algorithm also looked for evidence of flow limitation to detect hypopneas. The algorithm monitored the flow signal for changes in peak flow, and the shape of the inspiratory airflow signal that would be associated with flow limited breathing.
10956425|NCT00836758|OG000|Outcome|CPAP Device Compared to Manual PSG Scoring|This analysis focused on events detected by the CPAP device compared to Manual PSG scoring. The two arms were compared to demonstrate agreement.
10956426|NCT00836758|EG000|Reported Event|CPAP Device|"Breathing event detection (AED) by the CPAP device will be compared to breathing event detection by a simultaneous PSG (manual PSG scoring).~Analysis with AED and manual PSG scoring: The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring."
10956427|NCT00836810|BG000|Baseline|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
10956428|NCT00836810|BG001|Baseline|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
10956429|NCT00836810|BG002|Baseline|Total|Total of all reporting groups
10956430|NCT00836810|FG000|Participant Flow|Timed Release Tablet Prednisone|"11 patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
10956431|NCT00836810|FG001|Participant Flow|Standard Prednisolone|"11 patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
10956432|NCT00836810|OG000|Outcome|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
10956433|NCT00836810|OG001|Outcome|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
10956434|NCT00836810|EG000|Reported Event|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
10956435|NCT00836810|EG001|Reported Event|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
10956436|NCT00836875|BG000|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
10956437|NCT00836875|BG001|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
10956438|NCT00836875|BG002|Baseline|Total|Total of all reporting groups
10963756|NCT00874029|OG000|Outcome|Overall, Satisfaction With Uterine Fibroid Treatment|Patients were asked, overall, how satisfied with their uterine fibroid treatment.
10956439|NCT00836875|FG000|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
10956440|NCT00836875|FG001|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
10956441|NCT00836875|OG000|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
10956442|NCT00836875|OG001|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
10956443|NCT00836875|EG000|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
10956444|NCT00836875|EG001|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
10956445|NCT00836888|BG000|Baseline|ONO-4538 1mg/kg Cohorts|Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
10956446|NCT00836888|BG001|Baseline|ONO-4538 3mg/kg Cohorts|Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
10956447|NCT00836888|BG002|Baseline|ONO-4538 10mg/kg Cohorts|Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
10956448|NCT00836888|BG003|Baseline|ONO-4538 20mg/kg Cohorts|Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
10956449|NCT00836888|BG004|Baseline|Total|Total of all reporting groups
10956450|NCT00836888|FG000|Participant Flow|ONO-4538 1mg/kg Cohorts|Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
10956451|NCT00836888|FG001|Participant Flow|ONO-4538 3mg/kg Cohorts|Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
10956452|NCT00836888|FG002|Participant Flow|ONO-4538 10mg/kg Cohorts|Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
10956453|NCT00836888|FG003|Participant Flow|ONO-4538 20mg/kg Cohorts|Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
10956454|NCT00836888|OG000|Outcome|ONO-4538 1mg/kg Cohorts|Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
10956455|NCT00836888|OG001|Outcome|ONO-4538 3mg/kg Cohorts|Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
10956456|NCT00836888|OG002|Outcome|ONO-4538 10mg/kg Cohorts|Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
10956457|NCT00836888|OG003|Outcome|ONO-4538 20mg/kg Cohorts|Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
10956458|NCT00836888|EG000|Reported Event|ONO-4538 1mg/kg Cohorts|Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
10956459|NCT00836888|EG001|Reported Event|ONO-4538 3mg/kg Cohorts|Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
10956460|NCT00836888|EG002|Reported Event|ONO-4538 10mg/kg Cohorts|Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
10956461|NCT00836888|EG003|Reported Event|ONO-4538 20mg/kg Cohorts|Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
10956462|NCT00836927|BG000|Baseline|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
10956463|NCT00836927|BG001|Baseline|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
10956464|NCT00836927|BG002|Baseline|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
10956465|NCT00836927|BG003|Baseline|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
10956466|NCT00836927|BG004|Baseline|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
10956467|NCT00836927|BG005|Baseline|Total|Total of all reporting groups
10956468|NCT00836927|FG000|Participant Flow|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
10956469|NCT00836927|FG001|Participant Flow|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
10956470|NCT00836927|FG002|Participant Flow|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
10956471|NCT00836927|FG003|Participant Flow|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
10956472|NCT00836927|FG004|Participant Flow|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
10956473|NCT00836927|OG000|Outcome|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
10956474|NCT00836927|OG001|Outcome|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
10956475|NCT00836927|OG002|Outcome|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
10956476|NCT00836927|OG003|Outcome|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
10956477|NCT00836927|OG004|Outcome|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
10956478|NCT00836927|EG000|Reported Event|Ridaforolimus 10 mg Days 1-5 (Up to Data Cut-Off)|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
10956479|NCT00836927|EG001|Reported Event|Ridaforolimus 10 mg Days 1-6 (Up to Data Cut-Off)|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
10956480|NCT00836927|EG002|Reported Event|Ridaforolimus 20 mg Days 1-5 (Up to Data Cut-Off)|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
10956481|NCT00836927|EG003|Reported Event|Ridaforolimus 30 mg Days 1-5 (Up to Data Cut-Off)|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
10956482|NCT00836927|EG004|Reported Event|Ridaforolimus 40 mg Days 1-5 (Up to Data Cut-Off)|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
10956483|NCT00836927|EG005|Reported Event|Ridaforolimus 10 mg Days 1-6 (Post Data Cut-Off)|Participants remaining on treatment after closure of the study database. Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
10956484|NCT00836927|EG006|Reported Event|Ridaforolimus 20 mg Days 1-5 (Post Data Cut-Off)|Participants remaining on treatment after closure of the study database. Ridaforolimus 20 mg administered orally once daily on Days 1-5 per week.
10956485|NCT00836953|BG000|Baseline|Study Group|Participants received study vaccine on Days 0 and 30.
10956486|NCT00836953|FG000|Participant Flow|Study Group|Participants received study vaccine on Days 0 and 30.
10956487|NCT00836953|OG000|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
10956488|NCT00836953|EG000|Reported Event|Study Group|Participants received study vaccine on Days 0 and 30.
10956489|NCT00837031|BG000|Baseline|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
10956490|NCT00837031|FG000|Participant Flow|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
10956491|NCT00837031|OG000|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
10956492|NCT00837031|EG000|Reported Event|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
10956493|NCT00837096|BG000|Baseline|V.A.C. Therapy|"Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.~V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing."
10956494|NCT00837096|BG001|Baseline|Moist Wound Therapy (MWT)|"t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air.~Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial"
10956495|NCT00837096|BG002|Baseline|Total|Total of all reporting groups
10956496|NCT00837096|FG000|Participant Flow|V.A.C. Therapy|"Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.~V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing."
10956497|NCT00837096|FG001|Participant Flow|Moist Wound Therapy (MWT)|"t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air.~Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial"
10956498|NCT00837096|OG000|Outcome|V.A.C. Therapy|"Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.~V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing."
10956499|NCT00837096|OG001|Outcome|Moist Wound Therapy (MWT)|"t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air.~Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial"
10956500|NCT00837096|EG000|Reported Event|V.A.C. Therapy|"Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.~V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing."
10956501|NCT00837096|EG001|Reported Event|Moist Wound Therapy (MWT)|"t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air.~Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial"
10956502|NCT00837148|BG000|Baseline|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
10956503|NCT00837148|FG000|Participant Flow|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
10956504|NCT00837148|OG000|Outcome|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
10956505|NCT00837148|EG000|Reported Event|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
10956506|NCT00837161|BG000|Baseline|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
10956507|NCT00837161|FG000|Participant Flow|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
10956508|NCT00837161|OG000|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
10956509|NCT00837161|EG000|Reported Event|HIFU Treatment|
10956510|NCT00837200|BG000|Baseline|Treatment|Oncaspar 2500 IU/m2 D1,15; Doxil 20mg/m2 D1,15; Decadron 20 mg D1,8,15,22
10956511|NCT00837200|FG000|Participant Flow|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
10956512|NCT00837200|OG000|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
10956513|NCT00837200|EG000|Reported Event|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
10956514|NCT00837213|BG000|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
10956515|NCT00837213|BG001|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
10956516|NCT00837213|BG002|Baseline|Total|Total of all reporting groups
10956517|NCT00837213|FG000|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
10956518|NCT00837213|FG001|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
10956519|NCT00837213|OG000|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
10956520|NCT00837213|OG001|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
10956521|NCT00837213|EG000|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
10956522|NCT00837213|EG001|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
10956523|NCT00837252|BG000|Baseline|Finasteride|
10956524|NCT00837252|FG000|Participant Flow|Finasteride|All five study participants (all of whom were diagnosed with chronic CSC) were administered a 5mg oral dose of finasteride daily for three months. After three months, the finasteride was withheld and the participants were observed for another three months.
10956525|NCT00837252|OG000|Outcome|Finasteride|
10956526|NCT00837252|EG000|Reported Event|Finasteride|
10956527|NCT00837330|BG000|Baseline|Ranibizumab 0.5 mg/ 0.05 cc|Intraocular injection of 0.5 mg /0.05 cc ranibizumab
10956528|NCT00837330|BG001|Baseline|Ranibizumab 0.3 mg/ 0.05 cc|Intraocular injection of 0.3 mg /0.05 cc ranibizumab
10956529|NCT00837330|BG002|Baseline|Total|Total of all reporting groups
10956530|NCT00837330|FG000|Participant Flow|Intraocular Injection 0.5 mg Ranibizumab|10 patients will receive intraocular injection 0.5 mg ranibizumab
10956531|NCT00837330|FG001|Participant Flow|Intraocular Injection 0.3 mg Ranibizumab|10 patients will receive intraocular injection 0.3 mg ranibizumab
10956532|NCT00837330|OG000|Outcome|Ranibizumab 0.5 mg|Intraocular injection of 0.5 mg ranibizumab
10956533|NCT00837330|OG001|Outcome|Ranibizumab 0.3 mg|Intraocular injection 0.3 mg ranibizumab
10956534|NCT00837330|EG000|Reported Event|Ranibizumab 0.5 mg|Intravitreal Injection of Ranibizumab 0.5 mg
10956535|NCT00837330|EG001|Reported Event|Ranibizumab 0.3 mg|Intravitreal Injection of Ranibizumab 0.5 mg
10956536|NCT00837434|BG000|Baseline|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
10956537|NCT00837434|BG001|Baseline|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
10956538|NCT00837434|BG002|Baseline|Total|Total of all reporting groups
10956539|NCT00837434|FG000|Participant Flow|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
10956540|NCT00837434|FG001|Participant Flow|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
10956541|NCT00837434|OG000|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
10956542|NCT00837434|OG001|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
10956543|NCT00837434|EG000|Reported Event|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
10956544|NCT00837434|EG001|Reported Event|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
10956545|NCT00837447|BG000|Baseline|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
10956546|NCT00837447|FG000|Participant Flow|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
10956547|NCT00837447|OG000|Outcome|High-Flexion Posterior Cruciate Retaining TKA|
10956548|NCT00837447|OG001|Outcome|High-Flexion Posterior Cruciate Scrificing TKA|
10956549|NCT00837447|EG000|Reported Event|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
10956550|NCT00837473|BG000|Baseline|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
10956551|NCT00837473|FG000|Participant Flow|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
10956552|NCT00837473|OG000|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
10956553|NCT00837473|EG000|Reported Event|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
10956554|NCT00837486|BG000|Baseline|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
10956555|NCT00837486|BG001|Baseline|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
10956556|NCT00837486|BG002|Baseline|Total|Total of all reporting groups
10956557|NCT00837486|FG000|Participant Flow|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
10956558|NCT00837486|FG001|Participant Flow|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
10956559|NCT00837486|OG000|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
10956560|NCT00837486|OG001|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
10956561|NCT00837486|OG000|Outcome|Long-term Open-label Treatment|All subjects received open-label active stimulation after the 16 week blinded-treatment phase.
10956562|NCT00837486|OG000|Outcome|All Enrolled Subjects|The 30 subjects were followed an average of 36 months after enrollment.
10956563|NCT00837486|EG000|Reported Event|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
10956564|NCT00837486|EG001|Reported Event|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
10956565|NCT00837512|BG000|Baseline|Entire Study Population|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
10956566|NCT00837512|FG000|Participant Flow|First: Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
10956567|NCT00837512|FG001|Participant Flow|First: Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
10956568|NCT00837512|OG000|Outcome|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
10956569|NCT00837512|OG001|Outcome|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
10956570|NCT00837512|EG000|Reported Event|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
10956571|NCT00837512|EG001|Reported Event|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
10956572|NCT00837577|BG000|Baseline|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
10956573|NCT00837577|BG001|Baseline|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
10956574|NCT00837577|BG002|Baseline|Total|Total of all reporting groups
10956575|NCT00837577|FG000|Participant Flow|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
10956576|NCT00837577|FG001|Participant Flow|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
10956577|NCT00837577|OG000|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
10956578|NCT00837577|OG001|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
10956579|NCT00837577|EG000|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
10956580|NCT00837577|EG001|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
11178838|NCT02051790|EG000|Reported Event|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
10956581|NCT00837577|EG002|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all participants who took sitagliptin in either treatment group: data from Week 0 to Week 52 for participants in the Sitagliptin/Sitagliptin group; data from Weeks 12 through Week 52 for participants in the Placebo/Sitagliptin group; and data from participants in either group who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
10956582|NCT00837590|BG000|Baseline|Acute Salsalate|"Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after a single dose of salsalate.~salsalate : Subjects will receive a single day of 4 gram/day of oral salsalate divided into 3 doses."
10956583|NCT00837590|BG001|Baseline|Chronic Salsalate - Lean|"Nondiabetic lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.~Salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses."
10956584|NCT00837590|BG002|Baseline|Chronic Salsalate - Obese|"Nondiabetic obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.~Salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses."
10956585|NCT00837590|BG003|Baseline|Total|Total of all reporting groups
10956586|NCT00837590|FG000|Participant Flow|Acute Salsalate|Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at after a single oral dose of salsalate
10956587|NCT00837590|FG001|Participant Flow|Chronic Salsalate - Obese|"Obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.~salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses."
10956588|NCT00837590|FG002|Participant Flow|Chronic Salsalate - Lean|"Lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.~salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses."
10956589|NCT00837590|OG000|Outcome|Acute Salsalate|Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after a single oral dose of salsalate
10956590|NCT00837590|OG001|Outcome|Chronic Salsalate - Obese|"Obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.~salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses."
10956591|NCT00837590|OG002|Outcome|Chronic Salsalate - Lean|"Lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.~salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses."
10956592|NCT00837590|EG000|Reported Event|Acute Salsalate|Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied before and after a single oral dose of salsalate.
10956593|NCT00837590|EG001|Reported Event|Chronic Salsalate - Obese|"Obese subjects will be studied in this arm. Subjects swill be studied at baseline and after 2 months of treatment with salsalate.~salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses."
10956594|NCT00837590|EG002|Reported Event|Chronic Salsalate - Lean|"Lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.~salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses."
10956595|NCT00837616|BG000|Baseline|Group A|Group A received the oral estradiol for 12 months
10956596|NCT00837616|BG001|Baseline|Group B|Group B received the transdermal estradiol for 12 months
10956597|NCT00837616|BG002|Baseline|Total|Total of all reporting groups
10956598|NCT00837616|FG000|Participant Flow|Oral Estradiol|Group A received the oral estradiol for 12 months
10956599|NCT00837616|FG001|Participant Flow|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
10956600|NCT00837616|OG000|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
10956601|NCT00837616|OG001|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
10956602|NCT00837616|EG000|Reported Event|Group A|Group A received the oral estradiol for 12 months
10956603|NCT00837616|EG001|Reported Event|Group B|Group B received the transdermal estradiol for 12 months
10956604|NCT00837694|BG000|Baseline|Non-Obese/0 kcal|Non-obese participants that received no snack food to consume for two weeks.
10956605|NCT00837694|BG001|Baseline|Non-Obese/100 kcal|Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.
10956606|NCT00837694|BG002|Baseline|Non-obese/300 kcal|Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.
10956607|NCT00837694|BG003|Baseline|Obese/0 kcal|Obese participants that received no food to consume for two weeks.
10956608|NCT00837694|BG004|Baseline|Obese/100 kcal|Obese participants that received a 100 kcal portion of food to consume daily for two weeks.
10956609|NCT00837694|BG005|Baseline|Obese/300 kcal|Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
10956610|NCT00837694|BG006|Baseline|Total|Total of all reporting groups
10956611|NCT00837694|FG000|Participant Flow|Non-Obese/0 kcal|Non-obese participants that received no snack food to consume for two weeks.
10956612|NCT00837694|FG001|Participant Flow|Non-Obese/100 kcal|Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.
11178839|NCT02051816|BG000|Baseline|Video Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~and~A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure"
11178840|NCT02051816|BG001|Baseline|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~and~A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure"
10956613|NCT00837694|FG002|Participant Flow|Non-obese/300 kcal|Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.
10956614|NCT00837694|FG003|Participant Flow|Obese/0 kcal|Obese participants that received no food to consume for two weeks.
10956615|NCT00837694|FG004|Participant Flow|Obese/100 kcal|Obese participants that received a 100 kcal portion of food to consume daily for two weeks.
11178841|NCT02051816|BG002|Baseline|Video Laryngoscopy and no Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~and~No apneic oxygenation"
10956616|NCT00837694|FG005|Participant Flow|Obese/300 kcal|Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
10956617|NCT00837694|OG000|Outcome|Non-Obese/0 kcal|Non-obese participants that received no snack food to consume for two weeks.
10956618|NCT00837694|OG001|Outcome|Non-Obese/100 kcal|Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.
10956619|NCT00837694|OG002|Outcome|Non-obese/300 kcal|Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.
10956620|NCT00837694|OG003|Outcome|Obese/0 kcal|Obese participants that received no food to consume for two weeks.
10956621|NCT00837694|OG004|Outcome|Obese/100 kcal|Obese participants that received a 100 kcal portion of food to consume daily for two weeks.
10956622|NCT00837694|OG005|Outcome|Obese/300 kcal|Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
10956623|NCT00837694|EG000|Reported Event|Non-Obese/0 kcal|Non-obese participants that received no snack food to consume for two weeks.
10956624|NCT00837694|EG001|Reported Event|Non-Obese/100 kcal|Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.
10956625|NCT00837694|EG002|Reported Event|Non-obese/300 kcal|Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.
10956626|NCT00837694|EG003|Reported Event|Obese/0 kcal|Obese participants that received no food to consume for two weeks.
10956627|NCT00837694|EG004|Reported Event|Obese/100 kcal|Obese participants that received a 100 kcal portion of food to consume daily for two weeks.
10956628|NCT00837694|EG005|Reported Event|Obese/300 kcal|Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
10956629|NCT00837759|BG000|Baseline|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
10956630|NCT00837759|FG000|Participant Flow|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
10956631|NCT00837759|OG000|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
10956632|NCT00837759|EG000|Reported Event|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
10956633|NCT00837811|BG000|Baseline|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
10956634|NCT00837811|BG001|Baseline|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
10956635|NCT00837811|BG002|Baseline|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
10956636|NCT00837811|BG003|Baseline|Total|Total of all reporting groups
10956637|NCT00837811|FG000|Participant Flow|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
10956638|NCT00837811|FG001|Participant Flow|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
10956639|NCT00837811|FG002|Participant Flow|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
10956640|NCT00837811|OG000|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
10956641|NCT00837811|OG001|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
10956642|NCT00837811|OG002|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
10956643|NCT00837811|OG000|Outcome|60 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks."
10956644|NCT00837811|OG001|Outcome|60/120 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total)."
10956645|NCT00837811|OG002|Outcome|60/120/60 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total)."
10956646|NCT00837811|OG003|Outcome|60 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.~No study drug was administered during the post-study treatment follow-up."
10956647|NCT00837811|OG004|Outcome|60/120 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.~No study drug was administered during the post-study treatment follow-up."
10956648|NCT00837811|OG005|Outcome|60/120/60 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.~No study drug was administered during the post-study treatment follow-up."
10956649|NCT00837811|EG000|Reported Event|60 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks."
11357670|NCT03750955|EG003|Reported Event|Systemic Adverse Events|Adverse Events that occurred during the Gingivitis Induction Phase of 2 weeks and the Resolution Phase 2 weeks but are not specifically attributable to either the Plaque Induced Gingivitis intervention or the Oral Hygiene Maintenance intervention as the two interventions occurred simultaneously in each participant.
10956650|NCT00837811|EG001|Reported Event|60/120 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total)."
10956651|NCT00837811|EG002|Reported Event|60/120/60 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total)."
10956652|NCT00837811|EG003|Reported Event|60 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.~No study drug was administered during the post-study treatment follow-up."
10956653|NCT00837811|EG004|Reported Event|60/120 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.~No study drug was administered during the post-study treatment follow-up."
10956654|NCT00837811|EG005|Reported Event|60/120/60 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and a dose decrease back to 60 mg LY2127399 during study treatment.~No study drug was administered during the post-study treatment follow-up."
10956655|NCT00837824|BG000|Baseline|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
10956656|NCT00837824|BG001|Baseline|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
10956657|NCT00837824|BG002|Baseline|Total|Total of all reporting groups
10956658|NCT00837824|FG000|Participant Flow|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
10956659|NCT00837824|FG001|Participant Flow|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
10956660|NCT00837824|OG000|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
10956661|NCT00837824|OG001|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
10956662|NCT00837824|EG000|Reported Event|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
10956663|NCT00837824|EG001|Reported Event|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
10956664|NCT00837824|EG002|Reported Event|Total|
10956665|NCT00837876|BG000|Baseline|Treatment|Sorafenib + Erlotinib
10956666|NCT00837876|FG000|Participant Flow|Treatment|Sorafenib + Erlotinib
10956667|NCT00837876|OG000|Outcome|Treatment|Sorafenib + Erlotinib
10956668|NCT00837876|EG000|Reported Event|Treatment|Sorafenib + Erlotinib
10956669|NCT00837902|BG000|Baseline|White Participants--Atenolol|Unrelated black and white American subjects were eligible to participate if they were between 18 and 50 years old and had no clinically significant abnormality based on medical history, physical exam, electrocardiogram and routine laboratory testing. Subjects were free of medications for at least 1 week. They also received an alcohol and caffeine free diet for 6 days prior to the study.
10956670|NCT00837902|BG001|Baseline|Black Participants-Atenolol|Unrelated black and white American subjects were eligible to participate if they were between 18 and 50 years old and had no clinically significant abnormality based on medical history, physical exam, electrocardiogram and routine laboratory testing. Subjects were free of medications for at least 1 week. They also received an alcohol and caffeine free diet for 6 days prior to the study
10956671|NCT00837902|BG002|Baseline|Total|Total of all reporting groups
10956672|NCT00837902|FG000|Participant Flow|White Participants--Atenolol|Unrelated white American subjects
10956673|NCT00837902|FG001|Participant Flow|Black Participants-Atenolol|Unrelated black American subjects
10956674|NCT00837902|OG000|Outcome|GLN/GLN|One of 3 genotypes for GRK5, GLN/GLN
10956675|NCT00837902|OG001|Outcome|GLN/LEU|One of 3 genotypes for GRK5, GLN/LEU
10956676|NCT00837902|OG002|Outcome|LEU/LEU|One of 3 genotypes for GRK5, LEU/LEU.
10956677|NCT00837902|EG000|Reported Event|White Participants--Atenolol|Unrelated black and white American subjects were eligible to participate if they were between 18 and 50 years old and had no clinically significant abnormality based on medical history, physical exam, electrocardiogram and routine laboratory testing. Subjects were free of medications for at least 1 week. They also received an alcohol and caffeine free diet for 6 days prior to the study.
10956678|NCT00837902|EG001|Reported Event|Black Participants-Atenolol|Unrelated black and white American subjects were eligible to participate if they were between 18 and 50 years old and had no clinically significant abnormality based on medical history, physical exam, electrocardiogram and routine laboratory testing. Subjects were free of medications for at least 1 week. They also received an alcohol and caffeine free diet for 6 days prior to the study
10956679|NCT00837967|BG000|Baseline|All Study Participants|
10956680|NCT00837967|FG000|Participant Flow|Symbicort First, Then Terbutaline|Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
10956681|NCT00837967|FG001|Participant Flow|Terbutaline First, Then Symbicort|Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
10956682|NCT00837967|OG000|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
10956683|NCT00837967|OG001|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
10956684|NCT00837967|EG000|Reported Event|Symbicort|Symbicort Turbuhaler 160/4.5μg for 3 days
10956685|NCT00837967|EG001|Reported Event|Terbutaline|Terbutaline Turbuhaler 0.4 mg for 3 days
10956686|NCT00838006|BG000|Baseline|Cognitive Bias Modification|Soldiers randomized to Cognitive Bias Modification for Interpretation training arm
10956687|NCT00838006|BG001|Baseline|Heart Rate Variability Biofeedback|Soldiers randomized to Heart Rate Variability Biofeedback training arm
10956688|NCT00838006|BG002|Baseline|Control|Soldiers randomly assigned to Control group
10956689|NCT00838006|BG003|Baseline|Total|Total of all reporting groups
10956690|NCT00838006|FG000|Participant Flow|Heart Rate Variability Biofeedback Training|"Heart rate variability biofeedback training and iPod with Breath Pacer app~heart rate variability biofeedback: Heart rate variability biofeedback,1 session plus handheld device"
10956691|NCT00838006|FG001|Participant Flow|Cognitive Bias Modification Training|"Cognitive bias modification training and iPod with cognitive bias training app~Cognitive bias modification training: Cognitive bias modification training - 1 session plus handheld device"
10956692|NCT00838006|FG002|Participant Flow|Control Group|"No additional resilience training and iPod with no resilience training apps~Sham Comparator: Subjects received iPod without a study app and no additional resilience training"
10956693|NCT00838006|OG000|Outcome|HRV Biofeedback|Soldiers randomized the heart rate variability biofeedback training arm
10956694|NCT00838006|OG001|Outcome|Cognitive Bias Modification Training|Soldiers randomized to the cognitive bias modification for interpretation training arm
10956695|NCT00838006|OG002|Outcome|Control|Soldiers randomized to the control arm
10956696|NCT00838006|OG000|Outcome|Heart Rate Variability Biofeedback Training|Soldiers randomized the heart rate variability biofeedback training arm
10956697|NCT00838006|OG001|Outcome|Cognitive Bias Modification Training|Soldiers randomized to the Cognitive Bias Modification for Interpretation training arm
10956698|NCT00838006|EG000|Reported Event|HRV Biofeedback|Soldiers randomized to heart rate variability biofeedback training arm
10956699|NCT00838006|EG001|Reported Event|Cognitive Bias Modification Training|Soldiers randomized to Cognitive Bias Modification for Interpretation training arm
10956700|NCT00838006|EG002|Reported Event|Control|Soldiers randomized to the control arm
10956701|NCT00838097|BG000|Baseline|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
10956702|NCT00838097|FG000|Participant Flow|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
10956703|NCT00838097|OG000|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
10956704|NCT00838097|EG000|Reported Event|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
10956705|NCT00838110|BG000|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
10956706|NCT00838110|BG001|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
10956707|NCT00838110|BG002|Baseline|Total|Total of all reporting groups
10956708|NCT00838110|FG000|Participant Flow|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
10956709|NCT00838110|FG001|Participant Flow|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
10956710|NCT00838110|FG002|Participant Flow|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
10956711|NCT00838110|FG003|Participant Flow|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
10956712|NCT00838110|OG000|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
10956713|NCT00838110|OG001|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
10956714|NCT00838110|OG000|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
10956715|NCT00838110|OG001|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
10956716|NCT00838110|OG000|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
10956717|NCT00838110|OG001|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg Dimebon (latrepirdine) tablet orally three times a day up to Week 12.
10956718|NCT00838110|EG000|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
10956719|NCT00838110|EG001|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
10956720|NCT00838162|BG000|Baseline|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956721|NCT00838162|BG001|Baseline|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956722|NCT00838162|BG002|Baseline|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956723|NCT00838162|BG003|Baseline|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
10956724|NCT00838162|BG004|Baseline|Total|Total of all reporting groups
10956725|NCT00838162|FG000|Participant Flow|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956726|NCT00838162|FG001|Participant Flow|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956727|NCT00838162|FG002|Participant Flow|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956728|NCT00838162|FG003|Participant Flow|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
10956729|NCT00838162|OG000|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956730|NCT00838162|OG001|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956731|NCT00838162|OG002|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956732|NCT00838162|OG003|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
10956733|NCT00838162|EG000|Reported Event|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956734|NCT00838162|EG001|Reported Event|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956735|NCT00838162|EG002|Reported Event|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
10956736|NCT00838162|EG003|Reported Event|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
10956737|NCT00838201|BG000|Baseline|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
10956738|NCT00838201|BG001|Baseline|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
10956739|NCT00838201|BG002|Baseline|Total|Total of all reporting groups
10956740|NCT00838201|FG000|Participant Flow|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
10956741|NCT00838201|FG001|Participant Flow|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
10956742|NCT00838201|OG000|Outcome|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
10956743|NCT00838201|OG001|Outcome|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
10956744|NCT00838201|EG000|Reported Event|Placebo/ Denosumab 60 mg Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
10956745|NCT00838201|EG001|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
10956746|NCT00838331|BG000|Baseline|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
10956747|NCT00838331|FG000|Participant Flow|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
10956748|NCT00838331|OG000|Outcome|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
10956749|NCT00838331|EG000|Reported Event|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
10956750|NCT00838435|BG000|Baseline|Sapropterin Dihydrochloride|A dose of 20 mg/kg dissolved in water or apple juice, administered once daily orally, with food.
10956751|NCT00838435|FG000|Participant Flow|Sapropterin Dihydrochloride|"A dose of 20 mg/kg dissolved in water or apple juice, administered once daily orally, with food.~Part 1: 95 subjects participated in Part 1.~Pharmacokinetic (PK) Sub-Study: 94 subjects participated in the PK substudy, one subject declined participation.~6-month Safety/Efficacy Sub-Study: 65 subjects met the minimum required score of 80, Kuvan responders, all 65 subjects participated in Safety/Efficacy Substudy.~Part 2: 65 subjects met the minimum required score of 80 at baseline (Month 2) neurocognitive tests, all 65 subjects participated in Part 2."
10956752|NCT00838435|OG000|Outcome|Kuvan 20 mg/kg Once Daily|"A dose of 20 mg/kg dissolved in water or apple juice, administered once daily orally, with food.~Part 2 (7 years): Part 1 determined that 71 subjects were Kuvan responders, defined as a 30% average reduction in blood Phe concentration during the first 4 weeks .This included 8 subjects who had Phe reductions less than 30% but were granted exemptions to participate in Part 2 of the study.~Sixty-five of these 71 subjects were enrolled in Part 2. All 65 subjects met the minimum required FSIQ test score of ≥80 at baseline (Month 2)."
11234403|NCT02434939|EG000|Reported Event|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
10956753|NCT00838435|OG000|Outcome|Part 2|"A dose of 20 mg/kg dissolved in water or apple juice, administered once daily orally, with food.~Part 2 (7 years): Sixty-five of the 71 subjects that were determined to be Kuvan responders in Part 1 were enrolled in Part 2. All 65 subjects met the minimum required IQ test score of ≥80 at baseline (Month 2)."
10956754|NCT00838435|OG000|Outcome|Sapropterin Dihydrochloride|"A dose of 20 mg/kg dissolved in water or apple juice, administered once daily orally, with food.~Part 2 (7 years): Sixty-five of the 71 subjects that were determined to be Kuvan responders in Part 1 were enrolled in Part 2. All 65 subjects met the minimum required IQ test score of ≥80 at baseline (Month 2)."
10956755|NCT00838435|OG000|Outcome|Sapropterin Dihydrochloride|"A dose of 20 mg/kg dissolved in water or apple juice, administered once daily orally, with food.~Substudy 2 (Pharmacokinetics Substudy): 94 subjects participated in the PK substudy, one subject declined participation."
10956756|NCT00838435|EG000|Reported Event|Safety Population|All subjects who enrolled in the study (Full Analysis Set) and received any study drug.
10956757|NCT00838513|BG000|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10956758|NCT00838513|FG000|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10956759|NCT00838513|OG000|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10956760|NCT00838513|EG000|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10956761|NCT00838539|BG000|Baseline|N120 + T15|Neratinib 120 mg qd + Temsirolimus 15 mg, IV, weekly
10956762|NCT00838539|BG001|Baseline|N120 + T25|Neratinib 120 mg qd + Temsirolimus 25 mg, IV, weekly
10956763|NCT00838539|BG002|Baseline|N120 + T50|Neratinib 120 mg qd + Temsirolimus 50 mg, IV, weekly
10956764|NCT00838539|BG003|Baseline|N120 + T75|Neratinib 120 mg qd + Temsirolimus 75mg, IV, weekly
10956765|NCT00838539|BG004|Baseline|N160 + T15|Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly
10956766|NCT00838539|BG005|Baseline|N160 + T25|Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly
10956767|NCT00838539|BG006|Baseline|N160 + T50|Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly
10956768|NCT00838539|BG007|Baseline|N160 + T75|Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly
10956769|NCT00838539|BG008|Baseline|N200 + T15|Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly
10956770|NCT00838539|BG009|Baseline|N200 + T25|Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly
10956771|NCT00838539|BG010|Baseline|N200 + T50|Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly
11178842|NCT02051816|BG003|Baseline|Direct Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~and~No apneic oxygenation"
10956772|NCT00838539|BG011|Baseline|N240 + T15|Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
10956773|NCT00838539|BG012|Baseline|Total|Total of all reporting groups
10956774|NCT00838539|FG000|Participant Flow|N120 + T15|Neratinib 120 mg + Temsirolimus 15 mg
10956775|NCT00838539|FG001|Participant Flow|N120 + T25|Neratinib 120 mg + Temsirolimus 25 mg
10956776|NCT00838539|FG002|Participant Flow|N120 + T50|Neratinib 120 mg + Temsirolimus 50 mg
10956777|NCT00838539|FG003|Participant Flow|N120 + T75|Neratinib 120 mg + Temsirolimus 75 mg
10956778|NCT00838539|FG004|Participant Flow|N160 + T15|Neratinib 160 mg + Temsirolimus 15 mg
10956779|NCT00838539|FG005|Participant Flow|N160 + T25|Neratinib 160 mg + Temsirolimus 25 mg
10956780|NCT00838539|FG006|Participant Flow|N160 + T50|Neratinib 160 mg + Temsirolimus 50 mg
10956781|NCT00838539|FG007|Participant Flow|N160 + T75|Neratinib 160 mg + Temsirolimus 75 mg
11178843|NCT02051816|BG004|Baseline|Total|Total of all reporting groups
11178844|NCT02051816|FG000|Participant Flow|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
10956782|NCT00838539|FG008|Participant Flow|N200 + T15|Neratinib 200 mg + Temsirolimus 15 mg
10956783|NCT00838539|FG009|Participant Flow|N200 + T25|Neratinib 200 mg + Temsirolimus 25 mg
10956784|NCT00838539|FG010|Participant Flow|N200 + T50|Neratinib 200 mg + Temsirolimus 50 mg
10956785|NCT00838539|FG011|Participant Flow|N240 + T15|Neratinib 240 mg + Temsirolimus 15 mg
10956786|NCT00838539|OG000|Outcome|Neratinib 120 mg|Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.
10956787|NCT00838539|OG001|Outcome|Neratinib 160 mg|Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.
10956788|NCT00838539|OG002|Outcome|Neratinib 200 mg|Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.
10956789|NCT00838539|OG003|Outcome|Neratinib 240 mg|Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.
10956790|NCT00838539|OG000|Outcome|MTD Ner With TEMS|Neratinib MTD in combination with Temsirolimus
10956791|NCT00838539|OG000|Outcome|MTD TEMS With Ner|Temsirolimus MTD in combination with Neratinib
10956792|NCT00838539|OG000|Outcome|N120 + T15|Neratinib 120 mg qd + Temsirolimus 15 mg, IV, weekly
10956793|NCT00838539|OG001|Outcome|N120 + T25|Neratinib 120 mg qd + Temsirolimus 25 mg, IV, weekly
10956794|NCT00838539|OG002|Outcome|N120 + T50|Neratinib 120 mg qd + Temsirolimus 50 mg, IV, weekly
10956795|NCT00838539|OG003|Outcome|N120 + T75|Neratinib 120 mg qd + Temsirolimus 75mg, IV, weekly
10956796|NCT00838539|OG004|Outcome|N160 + T15|Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly
10956797|NCT00838539|OG005|Outcome|N160 + T25|Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly
10956798|NCT00838539|OG006|Outcome|N160 + T50|Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly
10956799|NCT00838539|OG007|Outcome|N160 + T75|Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly
10956800|NCT00838539|OG008|Outcome|N200 + T15|Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly
10956801|NCT00838539|OG009|Outcome|N200 + T25|Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly
10956802|NCT00838539|OG010|Outcome|N200 + T50|Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly
10956803|NCT00838539|OG011|Outcome|N240 + T15|Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
10956804|NCT00838539|OG000|Outcome|Neratinib 120 mg + Temsirolimus|Neratinib 120 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
10956805|NCT00838539|OG001|Outcome|Neratinib 160 mg + Temsirolimus|Neratinib 160 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
10956806|NCT00838539|OG002|Outcome|Neratinib 200 mg + Temsirolimus|Neratinib 200 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
10956807|NCT00838539|OG003|Outcome|Neratinib 240 mg + Temsirolimus|Neratinib 240 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
10956808|NCT00838539|OG000|Outcome|Temsirolimus 15 mg|Neratinib at indicated dose levels with Temsirolimus 15 mg, IV, once weekly
10956809|NCT00838539|OG001|Outcome|Temsirolimus 25 mg|Neratinib at indicated dose levels with Temsirolimus 15 mg, IV, once weekly
10956810|NCT00838539|OG002|Outcome|Temsirolimus 50 mg|Neratinib at indicated dose levels with Temsirolimus 50 mg, IV, once weekly
10956811|NCT00838539|OG003|Outcome|Temsirolums 75 mg|Neratinib at indicated dose levels with Temsirolimus 75 mg, IV, once weekly
10956812|NCT00838539|EG000|Reported Event|N120 + T15|Neratinib 120 mg qd + Temsirolimus 15 mg, IV, weekly
10956813|NCT00838539|EG001|Reported Event|N120 + T25|Neratinib 120 mg qd + Temsirolimus 25 mg, IV, weekly
10956814|NCT00838539|EG002|Reported Event|N120 + T50|Neratinib 120 mg qd + Temsirolimus 50 mg, IV, weekly
10956815|NCT00838539|EG003|Reported Event|N120 + T75|Neratinib 120 mg qd + Temsirolimus 75 mg, IV, weekly
10956816|NCT00838539|EG004|Reported Event|N160 + T15|Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly
10956817|NCT00838539|EG005|Reported Event|N160 + T25|Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly
10956818|NCT00838539|EG006|Reported Event|N160 + T50|Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly
10956819|NCT00838539|EG007|Reported Event|N160 + T75|Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly
10956820|NCT00838539|EG008|Reported Event|N200 + T15|Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly
10956821|NCT00838539|EG009|Reported Event|N200 + T25|Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly
10956822|NCT00838539|EG010|Reported Event|N200 + T50|Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly
10956823|NCT00838539|EG011|Reported Event|N240 + T15|Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
10956824|NCT00838565|BG000|Baseline|Placebo|Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956825|NCT00838565|BG001|Baseline|PF-04236921 1 mg|PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956826|NCT00838565|BG002|Baseline|PF-04236921 10 mg|PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956827|NCT00838565|BG003|Baseline|PF-04236921 30 mg|PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956828|NCT00838565|BG004|Baseline|PF-04236921 100 mg|PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956829|NCT00838565|BG005|Baseline|PF-04236921 250 mg|PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956830|NCT00838565|BG006|Baseline|Total|Total of all reporting groups
10956831|NCT00838565|FG000|Participant Flow|Placebo|Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956832|NCT00838565|FG001|Participant Flow|PF-04236921 1 mg|PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956833|NCT00838565|FG002|Participant Flow|PF-04236921 10 mg|PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956834|NCT00838565|FG003|Participant Flow|PF-04236921 30 mg|PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956835|NCT00838565|FG004|Participant Flow|PF-04236921 100 mg|PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956836|NCT00838565|FG005|Participant Flow|PF-04236921 250 mg|PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956837|NCT00838565|OG000|Outcome|Placebo|Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10963757|NCT00874029|OG001|Outcome|How Effective Was This Treatment in Eliminating Symptoms|Patients were asked to respond in their opinion, how effective was this treatment in eliminating their symptoms.
10963758|NCT00874029|EG000|Reported Event|Safety Set|The Safety Set consisted of all subjects treated in the study.
10956838|NCT00838565|OG001|Outcome|PF-04236921 1 mg|PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956839|NCT00838565|OG002|Outcome|PF-04236921 10 mg|PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956840|NCT00838565|OG003|Outcome|PF-04236921 30 mg|PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956841|NCT00838565|OG004|Outcome|PF-04236921 100 mg|PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956842|NCT00838565|OG005|Outcome|PF-04236921 250 mg|PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956843|NCT00838565|OG000|Outcome|PF-04236921 1 mg|PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956844|NCT00838565|OG001|Outcome|PF-04236921 10 mg|PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956845|NCT00838565|OG002|Outcome|PF-04236921 30 mg|PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956846|NCT00838565|OG003|Outcome|PF-04236921 100 mg|PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956847|NCT00838565|OG004|Outcome|PF-04236921 250 mg|PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956848|NCT00838565|EG000|Reported Event|Placebo|Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956849|NCT00838565|EG001|Reported Event|PF-04236921 1 mg|PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956850|NCT00838565|EG002|Reported Event|PF-04236921 10 mg|PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956851|NCT00838565|EG003|Reported Event|PF-04236921 30 mg|PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956852|NCT00838565|EG004|Reported Event|PF-04236921 100 mg|PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956853|NCT00838565|EG005|Reported Event|PF-04236921 250 mg|PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
10956854|NCT00838578|BG000|Baseline|KRN330 + Irinotecan|open label, single arm
10956855|NCT00838578|FG000|Participant Flow|KRN330 + Irinotecan|"Phase 1____ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19)~Phase 2____ Weekly KRN330 (0.5 mg/kg)) (N=46)~Phase 1 and 2Combined (N=65)"
10956856|NCT00838578|OG000|Outcome|Regimen A: KRN330 Biweekly + Irinotecan Biweekly|"In treatment regimen A, both KRN330 and irinotecan (180 mg/m2) were administered biweekly(Weeks 1, 3, and 5).~Cohort 1: 1 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly Cohort 2: 0.5 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly"
10956857|NCT00838578|OG001|Outcome|Regimen B: KRN330 Weekly + Irinotecan Biweekly|treatment regimen B, KRN330 was administered weekly (Weeks 1, 2, 3, 4 and 5) and irinotecan (180 mg/m2) biweekly (Weeks 1, 3, and 5).
10956858|NCT00838578|OG002|Outcome|PH 2 Treatment: KRN330 Wkly + IRI Biwkly|The Phase 2 portion was a single arm study using the regimen and dose selected in Phase 1 (0.5 mg/kg KRN330 weekly and 180 mg/m2 irinotecan biweekly).
10956859|NCT00838578|EG000|Reported Event|Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly|"In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5):~Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2"
10956860|NCT00838578|EG001|Reported Event|Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly|In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)
10956861|NCT00838578|EG002|Reported Event|Phase 2: KRN330 Weekly + IRI Biweekly|The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion
10956862|NCT00838682|BG000|Baseline|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
10956863|NCT00838682|BG001|Baseline|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
10956864|NCT00838682|BG002|Baseline|Total|Total of all reporting groups
10956865|NCT00838682|FG000|Participant Flow|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
10956866|NCT00838682|FG001|Participant Flow|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
10956867|NCT00838682|OG000|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
10956868|NCT00838682|OG001|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
10956869|NCT00838682|EG000|Reported Event|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
10956870|NCT00838682|EG001|Reported Event|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
10956871|NCT00838695|BG000|Baseline|African Americans|"Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing~Phenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"
10956872|NCT00838695|BG001|Baseline|Caucasians|"Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing~Phenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"
10956873|NCT00838695|BG002|Baseline|Total|Total of all reporting groups
10956874|NCT00838695|FG000|Participant Flow|African Americans|"Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing~Phenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"
10956875|NCT00838695|FG001|Participant Flow|Caucasians|"Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing~Phenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"
10956876|NCT00838695|OG000|Outcome|African Americans|"Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing~Phenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"
10956877|NCT00838695|OG001|Outcome|Caucasians|"Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing~Phenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"
10956878|NCT00838695|EG000|Reported Event|African Americans|Participants who were of African American descent.
10956879|NCT00838695|EG001|Reported Event|Caucasians|Participants who were of Caucasian descent.
10956880|NCT00838903|BG000|Baseline|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956881|NCT00838903|BG001|Baseline|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10963759|NCT00874094|BG000|Baseline|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
10963760|NCT00874094|FG000|Participant Flow|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
10956882|NCT00838903|BG002|Baseline|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956883|NCT00838903|BG003|Baseline|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956884|NCT00838903|BG004|Baseline|Total|Total of all reporting groups
10956885|NCT00838903|FG000|Participant Flow|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956886|NCT00838903|FG001|Participant Flow|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956887|NCT00838903|FG002|Participant Flow|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956888|NCT00838903|FG003|Participant Flow|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956889|NCT00838903|OG000|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956890|NCT00838903|OG001|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956891|NCT00838903|OG002|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956892|NCT00838903|OG003|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956893|NCT00838903|EG000|Reported Event|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956894|NCT00838903|EG001|Reported Event|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956895|NCT00838903|EG002|Reported Event|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956896|NCT00838903|EG003|Reported Event|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10963761|NCT00874094|OG000|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
10963762|NCT00874094|EG000|Reported Event|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
10963763|NCT00874120|BG000|Baseline|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
10963764|NCT00874120|BG001|Baseline|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
10963765|NCT00874120|BG002|Baseline|Total|Total of all reporting groups
10963766|NCT00874120|FG000|Participant Flow|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
10963767|NCT00874120|FG001|Participant Flow|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
10956897|NCT00838916|BG000|Baseline|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956898|NCT00838916|BG001|Baseline|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956899|NCT00838916|BG002|Baseline|Total|Total of all reporting groups
10956900|NCT00838916|FG000|Participant Flow|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956901|NCT00838916|FG001|Participant Flow|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956902|NCT00838916|OG000|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956903|NCT00838916|OG001|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956904|NCT00838916|EG000|Reported Event|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956905|NCT00838916|EG001|Reported Event|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
10956906|NCT00838929|BG000|Baseline|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level I - 200 mg PO qd (initial starting dose)~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
10956907|NCT00838929|BG001|Baseline|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level II - 300 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
10956908|NCT00838929|BG002|Baseline|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
10956909|NCT00838929|BG003|Baseline|Total|Total of all reporting groups
10956910|NCT00838929|FG000|Participant Flow|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
10956911|NCT00838929|FG001|Participant Flow|Vorinostat (300 mg) and Radiation|
10956912|NCT00838929|FG002|Participant Flow|Vorinostat (400 mg) and Radiation|
10956913|NCT00838929|OG000|Outcome|Vorinostat and Radiation - All Participants|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
10956914|NCT00838929|EG000|Reported Event|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level I - 200 mg PO qd (initial starting dose)~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
10956915|NCT00838929|EG001|Reported Event|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level II - 300 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
10956916|NCT00838929|EG002|Reported Event|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
10956917|NCT00839072|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
10956918|NCT00839072|FG000|Participant Flow|Test (Trazodone Contramid® OAD) First|"1 * 300 mg Trazodone Contramid® OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Trazodone IR (Desyrel®) 100 mg tablet 8-hourly reference product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
10956919|NCT00839072|FG001|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 * 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone Contramid® OAD (Once-A-Day) 300 mg Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
11178845|NCT02051816|FG001|Participant Flow|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
11178846|NCT02051816|FG002|Participant Flow|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
11178847|NCT02051816|FG003|Participant Flow|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
11178848|NCT02051816|OG000|Outcome|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~Apneic Oxygenation~No Apneic Oxygenation"
11178849|NCT02051816|OG001|Outcome|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation~No Apneic Oxygenation"
11178850|NCT02051816|OG002|Outcome|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy~Direct Laryngoscopy"
10956920|NCT00839072|OG000|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
10956921|NCT00839072|OG001|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
11178851|NCT02051816|OG003|Outcome|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Video Laryngoscopy~Direct Laryngoscopy"
11178852|NCT02051816|OG000|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
10956922|NCT00839072|EG000|Reported Event|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
10963768|NCT00874120|OG000|Outcome|Phenylephrine|Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
11178853|NCT02051816|OG001|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
11178854|NCT02051816|OG002|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
11178855|NCT02051816|OG003|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
11178856|NCT02051816|EG000|Reported Event|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~Apneic Oxygenation~No Apneic Oxygenation"
11178857|NCT02051816|EG001|Reported Event|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation~No Apneic Oxygenation"
11178858|NCT02051816|EG002|Reported Event|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy~Direct Laryngoscopy"
11178859|NCT02051816|EG003|Reported Event|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Video Laryngoscopy~Direct Laryngoscopy"
11178860|NCT02052011|BG000|Baseline|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
11178861|NCT02052011|BG001|Baseline|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
10956923|NCT00839072|EG001|Reported Event|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
10956924|NCT00839098|BG000|Baseline|Control Group|Control Group
10956925|NCT00839098|BG001|Baseline|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
10956926|NCT00839098|BG002|Baseline|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
10956927|NCT00839098|BG003|Baseline|Total|Total of all reporting groups
10956928|NCT00839098|FG000|Participant Flow|Control Group|Control Group
10956929|NCT00839098|FG001|Participant Flow|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
10956930|NCT00839098|FG002|Participant Flow|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
10956931|NCT00839098|OG000|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
10956932|NCT00839098|OG001|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
10956933|NCT00839098|OG002|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
10956934|NCT00839098|EG000|Reported Event|Control Group|Control Group
10956935|NCT00839098|EG001|Reported Event|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
10956936|NCT00839098|EG002|Reported Event|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
10956937|NCT00839241|BG000|Baseline|Autologous Blood Transfusion|
10956938|NCT00839241|BG001|Baseline|Allogenic Blood Transfusion|
10956939|NCT00839241|BG002|Baseline|Total|Total of all reporting groups
10956940|NCT00839241|FG000|Participant Flow|Autologous Blood Transfusion|
10956941|NCT00839241|FG001|Participant Flow|Allogenic Blood Transfusion|
10956942|NCT00839241|OG000|Outcome|Autologous Blood Transfusion|
10956943|NCT00839241|OG001|Outcome|Allogenic Blood Transfusion|
10956944|NCT00839241|EG000|Reported Event|Autologous Blood Transfusion|
10956945|NCT00839241|EG001|Reported Event|Allogenic Blood Transfusion|
10963769|NCT00874120|OG001|Outcome|Placebo|Placebo twice daily for 7 days
10956946|NCT00839254|BG000|Baseline|10Pn3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956947|NCT00839254|BG001|Baseline|10Pn2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956948|NCT00839254|BG002|Baseline|Ctrl3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956949|NCT00839254|BG003|Baseline|Ctrl2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956950|NCT00839254|BG004|Baseline|10Pn7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956951|NCT00839254|BG005|Baseline|Ctrl7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956952|NCT00839254|BG006|Baseline|10Pn12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956953|NCT00839254|BG007|Baseline|Ctrl12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
11178862|NCT02052011|BG002|Baseline|Total|Total of all reporting groups
10956954|NCT00839254|BG008|Baseline|Total|Total of all reporting groups
10956955|NCT00839254|FG000|Participant Flow|10Pn3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10963770|NCT00874120|EG000|Reported Event|Phenylephrine|Phenylephrine HCL Extended Release tablets 30 mg twice daily for 7 days
10963771|NCT00874120|EG001|Reported Event|Placebo|Placebo twice daily for 7 days
10963772|NCT00874237|BG000|Baseline|All Subjects Treated|All 6 treatment sequences
10963773|NCT00874237|FG000|Participant Flow|Treatment Sequence ABC|Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
11178863|NCT02052011|FG000|Participant Flow|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
11178864|NCT02052011|FG001|Participant Flow|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
11178865|NCT02052011|OG000|Outcome|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
11178866|NCT02052011|OG001|Outcome|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
10956956|NCT00839254|FG001|Participant Flow|10Pn2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956957|NCT00839254|FG002|Participant Flow|Ctrl3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956958|NCT00839254|FG003|Participant Flow|Ctrl2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956959|NCT00839254|FG004|Participant Flow|10Pn7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956960|NCT00839254|FG005|Participant Flow|Ctrl7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956961|NCT00839254|FG006|Participant Flow|10Pn12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956962|NCT00839254|FG007|Participant Flow|Ctrl12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956963|NCT00839254|OG000|Outcome|10Pn3+1-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.
10956964|NCT00839254|OG001|Outcome|Ctrl-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
10956965|NCT00839254|OG000|Outcome|10Pn2+1-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.
10956966|NCT00839254|OG000|Outcome|10Pn7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.
10956967|NCT00839254|OG001|Outcome|Ctrl7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
10956968|NCT00839254|OG000|Outcome|10Pn12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.
10956969|NCT00839254|OG001|Outcome|Ctrl12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
10956970|NCT00839254|OG001|Outcome|Ctrl-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
10956971|NCT00839254|OG000|Outcome|10Pn7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called aslo 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.
10956972|NCT00839254|OG001|Outcome|10Pn2+1-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.
10956973|NCT00839254|OG002|Outcome|Ctrl-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
11178867|NCT02052011|EG000|Reported Event|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
11178868|NCT02052011|EG001|Reported Event|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
11178869|NCT02052141|BG000|Baseline|Treatment A-B (500 U/1000 U CINRYZE)|Participants received 500 units (U) of CINRYZE intravenous (IV) injection twice weekly (every 3 or 4 days) for 12 weeks (Treatment A) in Intervention period 1 followed by 1000 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 12 weeks (Treatment B) in Intervention period 2. There was no washout period between two intervention periods.
11178870|NCT02052141|BG001|Baseline|Treatment B-A (1000 U/500 U CINRYZE)|Participants received 1000 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 12 weeks (Treatment B) in Intervention period 1 followed by 500 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 12 weeks (Treatment A) in Intervention period 2. There was no washout period between two intervention periods.
11178871|NCT02052141|BG002|Baseline|Total|Total of all reporting groups
11178872|NCT02052141|FG000|Participant Flow|Treatment A-B (500 U/1000 U CINRYZE)|Participants received 500 units (U) of CINRYZE intravenous (IV) injection twice weekly (every 3 or 4 days) for 12 weeks (Treatment A) during intervention period 1 followed by 1000 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 12 weeks (Treatment B) during intervention period 2. There was no washout period between the two intervention periods.
10956974|NCT00839254|OG002|Outcome|Ctrl-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
10956975|NCT00839254|OG003|Outcome|10Pn7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.
10956976|NCT00839254|OG004|Outcome|Ctrl7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
10956977|NCT00839254|OG005|Outcome|10Pn12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.
10956978|NCT00839254|OG006|Outcome|Ctrl12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
10956979|NCT00839254|OG000|Outcome|10Pn3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956980|NCT00839254|OG001|Outcome|10Pn2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956981|NCT00839254|OG002|Outcome|Ctrl3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956982|NCT00839254|OG003|Outcome|Ctrl2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10956983|NCT00839254|OG004|Outcome|10Pn7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956984|NCT00839254|OG005|Outcome|Ctrl7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10963774|NCT00874237|FG001|Participant Flow|Treatment Sequence ACB|Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
10956985|NCT00839254|OG006|Outcome|10Pn12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956986|NCT00839254|OG007|Outcome|Ctrl12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956987|NCT00839254|OG000|Outcome|10Pn3+1-6W- 6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.
10956988|NCT00839254|OG001|Outcome|10Pn2+1-6W- 6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.
10956989|NCT00839254|OG002|Outcome|Ctrl-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
10956990|NCT00839254|OG003|Outcome|10Pn7- 11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.
10956991|NCT00839254|OG004|Outcome|Ctrl7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B-thio free (or HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months 1908 since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
10956992|NCT00839254|OG005|Outcome|10Pn12- 18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.
11178873|NCT02052141|FG001|Participant Flow|Treatment B-A (1000 U/500 U CINRYZE)|Participants received 1000 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 12 weeks (Treatment B) during intervention period 1 followed by 500 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 12 weeks (Treatment A) during intervention period 2. There was no washout period between the two intervention periods.
11178874|NCT02052141|OG000|Outcome|Treatment A (500 U CINRYZE)|Participants received 500 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 24 weeks (Intervention period 1 in sequence A-B and ntervention period 2 in sequence B-A). Each intervention period was of 12 weeks.
11178875|NCT02052141|OG001|Outcome|Treatment B (1000 U CINRYZE)|Participants received 1000 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 24 weeks (Intervention period 2 in sequence A-B and ntervention period 1 in sequence B-A). Each intervention period was of 12 weeks.
11178876|NCT02052141|EG000|Reported Event|Treatment A (500 U CINRYZE)|Participants received 500 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 24 weeks (Intervention period 1 in sequence A-B and ntervention period 2 in sequence B-A). Each intervention period was of 12 weeks.
10963775|NCT00874237|FG002|Participant Flow|Treatment Sequence BCA|Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
11178877|NCT02052141|EG001|Reported Event|Treatment B (1000 U CINRYZE)|Participants received 1000 U CINRYZE IV injection twice weekly (every 3 or 4 days) for 24 weeks (Intervention period 2 in sequence A-B and ntervention period 1 in sequence B-A). Each intervention period was of 12 weeks.
11178878|NCT02052310|BG000|Baseline|Roxadustat|Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
11178879|NCT02052310|BG001|Baseline|Epoetin Alfa|Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.
11178880|NCT02052310|BG002|Baseline|Total|Total of all reporting groups
10956993|NCT00839254|OG006|Outcome|Ctrl12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
10956994|NCT00839254|OG002|Outcome|Ctrl-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
10956995|NCT00839254|OG000|Outcome|10Pn7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956996|NCT00839254|OG001|Outcome|Ctrl7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956997|NCT00839254|OG000|Outcome|10Pn12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10963776|NCT00874237|FG003|Participant Flow|Treatment Sequence BAC|Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
10963777|NCT00874237|FG004|Participant Flow|Treatment Sequence CAB|Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
10963778|NCT00874237|FG005|Participant Flow|Treatment Sequence CBA|Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
11178881|NCT02052310|FG000|Participant Flow|Roxadustat|Participants received roxadustat tablets, administered orally 3 times weekly (TIW). Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kilograms (kg)] and high weight [>70 to 160 kg] participants received 70 and 100 milligrams [mg] roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target hemoglobin (Hb) values (10-12 grams [g]/deciliter [dL]) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
11178882|NCT02052310|FG001|Participant Flow|Epoetin Alfa|Participants on hemodialysis (HD) received epoetin alfa, administered intravenously (IV) TIW, with starting doses and dose adjustment rules as per United States Package Insert (USPI) or summary of product characteristics (SmPC). Participants on home HD or peritoneal dialysis (PD) received epoetin alfa, administered subcutaneously (SC) as per the country-specific product label (USPI or SmPC) or local standard of care (SOC). The maximum treatment duration was 226.9 weeks.
11178883|NCT02052310|OG000|Outcome|Roxadustat|Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
11178884|NCT02052310|OG001|Outcome|Epoetin Alfa|Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.
10956998|NCT00839254|OG001|Outcome|Ctrl12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10956999|NCT00839254|OG001|Outcome|Ctrl3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10957000|NCT00839254|OG000|Outcome|10Pn2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10957001|NCT00839254|OG001|Outcome|Ctrl2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10957002|NCT00839254|EG000|Reported Event|10Pn3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10957003|NCT00839254|EG001|Reported Event|10Pn2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10957004|NCT00839254|EG002|Reported Event|Ctrl3+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10957005|NCT00839254|EG003|Reported Event|Ctrl2+1-6W-6M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10957006|NCT00839254|EG004|Reported Event|10Pn7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10957007|NCT00839254|EG005|Reported Event|Ctrl7-11M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10957008|NCT00839254|EG006|Reported Event|10Pn12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10957009|NCT00839254|EG007|Reported Event|Ctrl12-18M/053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10957010|NCT00839306|BG000|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957011|NCT00839306|BG001|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957012|NCT00839306|BG002|Baseline|Total|Total of all reporting groups
10957013|NCT00839306|FG000|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957014|NCT00839306|FG001|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957015|NCT00839306|OG000|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957016|NCT00839306|OG001|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose inlcuded 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957017|NCT00839306|OG001|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957018|NCT00839306|EG000|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957019|NCT00839306|EG001|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10957020|NCT00839319|BG000|Baseline|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
10957021|NCT00839319|BG001|Baseline|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
10957022|NCT00839319|BG002|Baseline|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
10957023|NCT00839319|BG003|Baseline|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
10957024|NCT00839319|BG004|Baseline|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
10957025|NCT00839319|BG005|Baseline|Total|Total of all reporting groups
10957026|NCT00839319|FG000|Participant Flow|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
10957027|NCT00839319|FG001|Participant Flow|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
10957028|NCT00839319|FG002|Participant Flow|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
10957029|NCT00839319|FG003|Participant Flow|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
10957030|NCT00839319|FG004|Participant Flow|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
10957031|NCT00839319|OG000|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
10957032|NCT00839319|OG001|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
10957033|NCT00839319|OG002|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
10957034|NCT00839319|OG003|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
10957035|NCT00839319|OG004|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
10957036|NCT00839319|EG000|Reported Event|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
10957037|NCT00839319|EG001|Reported Event|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
10957038|NCT00839319|EG002|Reported Event|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
10957039|NCT00839319|EG003|Reported Event|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
10957040|NCT00839319|EG004|Reported Event|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
10957041|NCT00839332|BG000|Baseline|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957042|NCT00839332|BG001|Baseline|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957043|NCT00839332|BG002|Baseline|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
10957044|NCT00839332|BG003|Baseline|Total|Total of all reporting groups
10957045|NCT00839332|FG000|Participant Flow|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 milligrams/meter squared (mg/m^2) LY2603618 as a 1-hour continuous intravenous (IV) infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957046|NCT00839332|FG001|Participant Flow|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957047|NCT00839332|FG002|Participant Flow|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
10957048|NCT00839332|OG000|Outcome|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70-250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957049|NCT00839332|OG000|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957050|NCT00839332|OG001|Outcome|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
10957051|NCT00839332|OG000|Outcome|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957052|NCT00839332|EG000|Reported Event|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957053|NCT00839332|EG001|Reported Event|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
10957054|NCT00839332|EG002|Reported Event|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
10957055|NCT00839423|BG000|Baseline|Placebo|capsules, daily, orally
10957056|NCT00839423|BG001|Baseline|Vortioxetine 5 mg|encapsulated tablets, daily, orally
10957057|NCT00839423|BG002|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
10957058|NCT00839423|BG003|Baseline|Venlafaxine 225 mg|capsules, daily, orally
10957059|NCT00839423|BG004|Baseline|Total|Total of all reporting groups
10957060|NCT00839423|FG000|Participant Flow|Placebo|capsules, daily, orally
11234404|NCT02434939|EG001|Reported Event|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
10957061|NCT00839423|FG001|Participant Flow|Vortioxetine 5 mg|encapsulated tablets, daily, orally
10957062|NCT00839423|FG002|Participant Flow|Vortioxetine 10 mg|encapsulated tablets, daily, orally
10957063|NCT00839423|FG003|Participant Flow|Venlafaxine 225 mg|capsules, daily, orally
10957064|NCT00839423|OG000|Outcome|Placebo|capsules, daily, orally
10957065|NCT00839423|OG001|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
10957066|NCT00839423|OG002|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
10957067|NCT00839423|OG003|Outcome|Venlafaxine 225 mg|capsules, daily, orally
10957068|NCT00839423|EG000|Reported Event|Placebo|
10957069|NCT00839423|EG001|Reported Event|Vortioxetine 5 mg|
10957070|NCT00839423|EG002|Reported Event|Vortioxetine 10 mg|
10957071|NCT00839423|EG003|Reported Event|Venlafaxine 225 mg|
10957072|NCT00839436|BG000|Baseline|3 mcg/kg Cohort|
10957073|NCT00839436|BG001|Baseline|10 mcg/kg Cohort|
10957074|NCT00839436|BG002|Baseline|20 mcg/kg Cohort|
10957075|NCT00839436|BG003|Baseline|Total|Total of all reporting groups
10957076|NCT00839436|FG000|Participant Flow|3 mcg/kg Cohort|
10957077|NCT00839436|FG001|Participant Flow|10 mcg/kg Cohort|
10957078|NCT00839436|FG002|Participant Flow|20 mcg/kg Cohort|
10957079|NCT00839436|OG000|Outcome|3 mcg/kg Cohort|
10957080|NCT00839436|OG001|Outcome|10 mcg/kg Cohort|
10957081|NCT00839436|OG002|Outcome|20 mcg/kg Cohort|
10957082|NCT00839436|EG000|Reported Event|3 mcg/kg Cohort|
10957083|NCT00839436|EG001|Reported Event|10 mcg/kg Cohort|
10957084|NCT00839436|EG002|Reported Event|20 mcg/kg Cohort|
10957085|NCT00839527|BG000|Baseline|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957086|NCT00839527|BG001|Baseline|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957087|NCT00839527|BG002|Baseline|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957088|NCT00839527|BG003|Baseline|Total|Total of all reporting groups
10957089|NCT00839527|FG000|Participant Flow|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957090|NCT00839527|FG001|Participant Flow|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957091|NCT00839527|FG002|Participant Flow|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957092|NCT00839527|OG000|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957093|NCT00839527|OG001|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957094|NCT00839527|OG002|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957095|NCT00839527|OG001|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957096|NCT00839527|OG002|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957097|NCT00839527|EG000|Reported Event|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957098|NCT00839527|EG001|Reported Event|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957099|NCT00839527|EG002|Reported Event|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
10957100|NCT00839540|BG000|Baseline|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
10957101|NCT00839540|BG001|Baseline|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
10957102|NCT00839540|BG002|Baseline|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
10957103|NCT00839540|BG003|Baseline|Total|Total of all reporting groups
10957104|NCT00839540|FG000|Participant Flow|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
10957105|NCT00839540|FG001|Participant Flow|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
10957106|NCT00839540|FG002|Participant Flow|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
10957107|NCT00839540|OG000|Outcome|Log Inhibition of 50 mg/Day Caspofungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Caspofungin based on 50 mg/day dosing, measured as Ex-vivo effect.
10957108|NCT00839540|OG001|Outcome|Log Inhibition of 100 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 100 mg/day dosing, measured as Ex-vivo effect.
10957109|NCT00839540|OG002|Outcome|Log Inhibition of 200 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 200 mg/day dosing, measured as Ex-vivo effect.
10957110|NCT00839540|EG000|Reported Event|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
11178885|NCT02052310|EG000|Reported Event|Roxadustat|Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
10957111|NCT00839540|EG001|Reported Event|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
10957112|NCT00839540|EG002|Reported Event|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
10957113|NCT00839800|BG000|Baseline|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
10957114|NCT00839800|BG001|Baseline|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
10957115|NCT00839800|BG002|Baseline|Total|Total of all reporting groups
10957116|NCT00839800|FG000|Participant Flow|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
10957117|NCT00839800|FG001|Participant Flow|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
10957118|NCT00839800|OG000|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
10957119|NCT00839800|OG001|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
10957120|NCT00839800|EG000|Reported Event|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
10957121|NCT00839800|EG001|Reported Event|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
10957122|NCT00839852|BG000|Baseline|Cariprazine|Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
10957123|NCT00839852|FG000|Participant Flow|Cariprazine|Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
10957124|NCT00839852|OG000|Outcome|Cariprazine|Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
10957125|NCT00839852|EG000|Reported Event|Cariprazine|Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
10957126|NCT00839917|BG000|Baseline|ProQuad™|Single subcutaneous 0.5 mL vaccination
10957127|NCT00839917|BG001|Baseline|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
10957128|NCT00839917|BG002|Baseline|Total|Total of all reporting groups
10957129|NCT00839917|FG000|Participant Flow|ProQuad™|Single subcutaneous 0.5 mL vaccination
10957130|NCT00839917|FG001|Participant Flow|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
10957131|NCT00839917|OG000|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
10957132|NCT00839917|OG001|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
10957133|NCT00839917|EG000|Reported Event|ProQuad™|Single subcutaneous 0.5 mL vaccination
10957134|NCT00839917|EG001|Reported Event|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
10957135|NCT00839956|BG000|Baseline|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
10957136|NCT00839956|FG000|Participant Flow|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
10957137|NCT00839956|OG000|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
10957138|NCT00839956|EG000|Reported Event|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
10957139|NCT00839982|BG000|Baseline|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957140|NCT00839982|FG000|Participant Flow|Dose Level 1|"Patients receive clofarabine 10mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957141|NCT00839982|FG001|Participant Flow|Dose Level 2|"Patients receive clofarabine 20mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957142|NCT00839982|FG002|Participant Flow|Dose Level 3|"Patients receive clofarabine 25mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957143|NCT00839982|FG003|Participant Flow|Dose Level 4|"Patients receive clofarabine 30mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957144|NCT00839982|OG000|Outcome|Dose Level 1|"Patients receive clofarabine 10 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957145|NCT00839982|OG001|Outcome|Dose Level 2|"Patients receive clofarabine 20 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957146|NCT00839982|OG002|Outcome|Dose Level 3|"Patients receive clofarabine 25 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957147|NCT00839982|OG003|Outcome|Dose Level 4|"Patients receive clofarabine 30 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957148|NCT00839982|OG000|Outcome|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
10957149|NCT00839982|EG000|Reported Event|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO cytarabine: Given SC"
10957150|NCT00840034|BG000|Baseline|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
10957151|NCT00840034|BG001|Baseline|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
10957152|NCT00840034|BG002|Baseline|Total|Total of all reporting groups
10957153|NCT00840034|FG000|Participant Flow|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets varying in strength) administered orally, once daily for up to 10 weeks, followed by a 2-week Taper Phase.
10957154|NCT00840034|FG001|Participant Flow|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
10957155|NCT00840034|OG000|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
10957156|NCT00840034|OG001|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
10957157|NCT00840034|EG000|Reported Event|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally, once daily for up to 10 weeks followed by a 2-week Taper Phase.
10957158|NCT00840034|EG001|Reported Event|Placebo|Placebo: 3 tablets orally, once daily for up to 12 weeks.
10957159|NCT00840034|EG002|Reported Event|LY2216684-Taper Phase|LY2216684: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks were administered 12 mg orally, once daily for 1 week followed by 6 mg once daily for 1 week or 6 mg orally, once daily for 2 weeks.
10957160|NCT00840034|EG003|Reported Event|Placebo-Taper Phase|Placebo: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks continued on placebo 3 tablets orally, once daily for 2 weeks.
10957161|NCT00840060|BG000|Baseline|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
10957162|NCT00840060|BG001|Baseline|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
10957163|NCT00840060|BG002|Baseline|Total|Total of all reporting groups
10957164|NCT00840060|FG000|Participant Flow|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
10957165|NCT00840060|FG001|Participant Flow|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
10957166|NCT00840060|OG000|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
10957167|NCT00840060|OG001|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
10957168|NCT00840060|EG000|Reported Event|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
10957169|NCT00840060|EG001|Reported Event|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
10957170|NCT00840086|BG000|Baseline|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
10957171|NCT00840086|FG000|Participant Flow|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
10957172|NCT00840086|OG000|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
10957173|NCT00840086|OG000|Outcome|Total (Part A + Part B)|Preventive treatment and treatment of bleeds: The doses were individualised based on the trough FVIII activity level. The doses could be adjusted by the investigator. The dose level chosen was 20-40 IU/kg every second day or 20-50 IU/kg three times per week (Part A + Part B). Subjects previously treated with turoctocog alpha were included in Part A.
10957174|NCT00840086|OG001|Outcome|Part C|Surgery sub-trial: This part of the trial included any of the patients from Part A and Part B that during the course of the trial needed to undergo a major or minor surgical procedure requiring at least 7 days of daily FVIII treatment, including the day of surgery. Patients received a preoperative loading dose of turoctocog alfa immediately prior to the surgical procedure. On the day of surgery and until Day 7 (included) turoctocog alfa was dose adjusted aiming for a trough level above 0.50 IU/mL. Day 8 to last day of the surgical recovery period (if relevant) turoctocog alfa was dosed according to local guidelines.
10957175|NCT00840086|OG002|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
11178886|NCT02052310|EG001|Reported Event|Epoetin Alfa|Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.
10957176|NCT00840086|EG000|Reported Event|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
10957177|NCT00840294|BG000|Baseline|Observation|Observation only for 2 weeks
10957178|NCT00840294|BG001|Baseline|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
10957179|NCT00840294|BG002|Baseline|Total|Total of all reporting groups
10957180|NCT00840294|FG000|Participant Flow|Observation|Observation only for 2 weeks
10957181|NCT00840294|FG001|Participant Flow|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
10957182|NCT00840294|OG000|Outcome|Observation|Observation only for 2 weeks
10957183|NCT00840294|OG001|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
10957184|NCT00840294|EG000|Reported Event|Observation|Observation only for 2 weeks
10957185|NCT00840294|EG001|Reported Event|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
10957186|NCT00840307|BG000|Baseline|Patient With Gastric Band|20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
10957187|NCT00840307|FG000|Participant Flow|Patient With Gastric Band|20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
10957188|NCT00840307|OG000|Outcome|Patient With Gastric Band|20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
10957189|NCT00840307|EG000|Reported Event|Patient With Gastric Band|20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
10957190|NCT00840450|BG000|Baseline|Paclitaxel and Imatinib Mesylate (Gleevec)|
10957191|NCT00840450|FG000|Participant Flow|Paclitaxel and Imatinib Mesylate (Gleevec)|
10957192|NCT00840450|OG000|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
10957193|NCT00840450|EG000|Reported Event|Paclitaxel and Imatinib Mesylate (Gleevec)|
10957194|NCT00840463|BG000|Baseline|Ambrisentan|Ambrisentan: Subjects will be initiated at 2.5 mg per day and increased to 5mg daily in 2 weeks and then 10mg daily if clinically tolerated (edema is controlled and symptoms are stable).
10957195|NCT00840463|BG001|Baseline|Placebo|Placebo: Sugar pill
10957196|NCT00840463|BG002|Baseline|Total|Total of all reporting groups
10957197|NCT00840463|FG000|Participant Flow|Ambrisentan|Ambrisentan: Subjects will be initiated at 2.5 mg per day and increased to 5mg daily in 2 weeks and then 10mg daily if clinically tolerated (edema is controlled and symptoms are stable).
10957198|NCT00840463|FG001|Participant Flow|Placebo|Placebo: Sugar pill
10957199|NCT00840463|OG000|Outcome|Ambrisentan|Ambrisentan: Subjects will be initiated at 2.5 mg per day and increased to 5mg daily in 2 weeks and then 10mg daily if clinically tolerated (edema is controlled and symptoms are stable).
10957200|NCT00840463|OG001|Outcome|Placebo|Placebo: Sugar pill
10957201|NCT00840463|EG000|Reported Event|Ambrisentan|Ambrisentan: Subjects will be initiated at 2.5 mg per day and increased to 5mg daily in 2 weeks and then 10mg daily if clinically tolerated (edema is controlled and symptoms are stable).
10957202|NCT00840463|EG001|Reported Event|Placebo|Placebo: Sugar pill
11178887|NCT02052414|BG000|Baseline|Gralise (Gabapentin ER)|"This is an open label trial to evaluate the efficacy of Gralise against fibromyalgia pain. If subject is taking gabapentinoids at the time of enrollment, subjects will be required to wash off the medication; otherwise they can start the starter pack for Gralise, and will eventually up titrated to treatment dose of 1800mg with evening meals per day.~Subjects will be followed every 4 weeks for total of 12 weeks. At the end of 12 weeks, subjects will be wash off the Gralise over 2 weeks, and will have a final end of treatment visit at week 15.~Subjects will be asked to rate their pain on numeric pain rating system (NPRS) as primary outcome measure. Subjects will be asked to assess Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Study (MOS) Sleep questionnaire, and Patient Global Impression of Change (PGIC) as secondary outcome measures.~At each follow up visits, occurrence of adverse events, and changes to concomitant medications were evaluated and recorded."
11178888|NCT02052414|FG000|Participant Flow|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
11178889|NCT02052414|OG000|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
11178890|NCT02052414|OG000|Outcome|Gralise (Gabapentin ER)|All subjects were assessed for occurrence of adverse events at follow up visits. All reported adverse events were tabulated, and presented in this study.
10957203|NCT00840658|BG000|Baseline|A: Didactic Safer Injection & Sexual Activity Education|In each city, 75 women will participate in a 60 minute lecture-format presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
10957204|NCT00840658|BG001|Baseline|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
10957205|NCT00840658|BG002|Baseline|C:Interactive Sexual Risk & Didactic Safer Injection Education|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI)and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a lecture-format presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
10957206|NCT00840658|BG003|Baseline|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
10957207|NCT00840658|BG004|Baseline|Total|Total of all reporting groups
10957208|NCT00840658|FG000|Participant Flow|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).~In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
10963779|NCT00874237|OG000|Outcome|Inhaled Loxapine 10 mg vs Placebo Crossover Subjects|"Largest upper 95% Upper Confidence Bound (msec) for Inhaled loxapine QTcI Differences from Placebo in Change from Predose Baseline~All upper CIs < 10 msec establishes this as a negative Thorough QT/QTc Study as defined in the ICH E14 guideline, 2005,"
10963780|NCT00874237|OG000|Outcome|Inhaled Loxapine 10 mg|Largest upper 95% Upper Confidence Bound (msec) for Inhaled loxapine QTcI Differences from Placebo in Change from Predose Baseline
11178891|NCT02052414|EG000|Reported Event|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
10957209|NCT00840658|FG001|Participant Flow|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.~This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.~In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
10957210|NCT00840658|FG002|Participant Flow|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.~In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
10957211|NCT00840658|FG003|Participant Flow|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
10957212|NCT00840658|OG000|Outcome|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).~In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
10957213|NCT00840658|OG001|Outcome|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.~This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.~In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
10957214|NCT00840658|OG002|Outcome|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.~In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
10957215|NCT00840658|OG003|Outcome|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
10957216|NCT00840658|OG000|Outcome|Intervention Group (Arm C+Arm D)|The intervention group was created by combining Arm C (i.e., interactive sexual risk and didactic safer injection education) and Arm D (i.e., interactive sexual risk and interactive injection risk)
10957217|NCT00840658|OG001|Outcome|Control Group (Arm A+Arm B)|The control group was created by combining Arm A (i.e., didactic sexual risk and didactic safer injection education) and Arm B (i.e., didactic sexual risk and interactive injection risk).
10957218|NCT00840658|OG000|Outcome|Intervention Group (Arm B+Arm D)|The Intervention Group was created by combining those who received Arm B (i.e., Interactive Injection Risk & Didactic Safer Sex Education) and Arm D(i.e., Interactive Injection &Sexual Risk Intervention).
10957219|NCT00840658|OG001|Outcome|Control Group (Arm A+ Arm C)|The Control Group was created by combining Arm A( i.e., those who received the Didactic Safer Injection & Sexual Activity Education) and Arm C (i.e., those who received Interactive Sexual Risk & Didactic Safer Injection Education).
10957220|NCT00840658|EG000|Reported Event|A: Didactic Safer Injection and Sexual Activity Education|In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
11178892|NCT02052440|BG000|Baseline|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
10957221|NCT00840658|EG001|Reported Event|B: Interactive Injection Risk Intervention and Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
10957222|NCT00840658|EG002|Reported Event|C:Interactive Sexual Risk Intervention & Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of MI and principles of SCT/TRA to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a didactic presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
10957223|NCT00840658|EG003|Reported Event|D: Interactive Injection and Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of MI and principles of SCT/TRA to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
10957224|NCT00840749|BG000|Baseline|CyberKnife Stereotactic Radiotherapy|CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
10957225|NCT00840749|BG001|Baseline|Surgery|Surgery: Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings
10957226|NCT00840749|BG002|Baseline|Total|Total of all reporting groups
10957227|NCT00840749|FG000|Participant Flow|CyberKnife Stereotactic Radiotherapy|CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
10957228|NCT00840749|FG001|Participant Flow|Surgery|Surgery: Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings
10957229|NCT00840749|OG000|Outcome|CyberKnife Stereotactic Radiotherapy|CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
10957230|NCT00840749|OG001|Outcome|Surgery|Surgery: Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings
10957231|NCT00840749|EG000|Reported Event|CyberKnife Stereotactic Radiotherapy|CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
11178893|NCT02052440|BG001|Baseline|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
11178894|NCT02052440|BG002|Baseline|Total|Total of all reporting groups
11178895|NCT02052440|FG000|Participant Flow|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
11178896|NCT02052440|FG001|Participant Flow|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
11178897|NCT02052440|OG000|Outcome|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
11178898|NCT02052440|OG001|Outcome|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
11178899|NCT02052440|EG000|Reported Event|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
11178900|NCT02052440|EG001|Reported Event|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
11178901|NCT02052466|BG000|Baseline|Reverse TSA Patients|Patients having undergone reverse Total Shoulder Arthroplasty (TSA) at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
11178902|NCT02052466|FG000|Participant Flow|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
10957232|NCT00840749|EG001|Reported Event|Surgery|Surgery: Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings
10963781|NCT00874237|OG000|Outcome|Inhaled Loxapine 10 mg|All subjects who received inhaled loxapine 10 mg (and oral) placebo and provided QTcI data
11178903|NCT02052466|OG000|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
11178904|NCT02052466|EG000|Reported Event|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
10963782|NCT00874237|OG001|Outcome|Inhaled Placebo|All subjects who received inhaled (and oral) placebo and provided QTcI data
11178905|NCT02052544|BG000|Baseline|Plasma Samples From Subjects Receiving Unfractionated Heparin|A total of 123 valid patients were recruited over three clinical centers (two in Europe, one in the US). The patients were selected from subjects receiving UFH therapy and who have given written informed consent. Excluded from the study were subjects treated with any other anticoagulants other than UFH, subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks, subjects known to have a congenital bleeding disorder, subjects known to show coagulation factor deficiencies and subjects known to have a coagulation inhibitor or an unexplained APTT prolongation.
11178906|NCT02052544|FG000|Participant Flow|Study Patients|Patients receiving unfractionated heparin (UFH)
11178907|NCT02052544|OG000|Outcome|Pefakit|Sensitivity and Specificity of Pefakit
11178908|NCT02052544|OG001|Outcome|Hemosil|Sensitivity and Specificity of Hemosil
11178909|NCT02052544|EG000|Reported Event|Study Patients|Patients receiving unfractionated heparin (UFH)
11178910|NCT02052557|BG000|Baseline|Bupivacaine|"30 milliliters (ml) of 0.5% marcaine with epinephrine~Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178911|NCT02052557|BG001|Baseline|Bupivacaine Liposome Suspension|"exparel 20ml, diluted with 10ml sterile saline for total of 30ml~Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178912|NCT02052557|BG002|Baseline|Total|Total of all reporting groups
11178913|NCT02052557|FG000|Participant Flow|Bupivacaine|"30 milliliters (ml) of 0.5% marcaine with epinephrine~Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178914|NCT02052557|FG001|Participant Flow|Bupivacaine Liposome Suspension|"exparel 20ml, diluted with 10ml sterile saline for total of 30ml~Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178915|NCT02052557|OG000|Outcome|Bupivacaine|"30 milliliters (ml) of 0.5% marcaine with epinephrine~Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178916|NCT02052557|OG001|Outcome|Bupivacaine Liposome Suspension|"exparel 20ml, diluted with 10ml sterile saline for total of 30ml~Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
10957233|NCT00840970|BG000|Baseline|All Patients|"All Patients includes the Pilot 15 mm (n=7), Efficacy 25 mm (n=38 [Pilot n=13,Pivotal Phases n=25]) and Safety/PK 25 mm (n=5) groups.~Pilot 15 mm and Efficacy 25 mm groups used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). In Pilot 15 mm group, patients in treatment arm received a 15mm length splint (220ug MF). In Efficacy 25 mm group, patients in the treatment arm received a 25mm length splint (370ug MF).~Safety/PK group used a non-randomized design wherein following FESS a drug-coated splints (25 mm length with 370 ug MF) were placed bilaterally in both ethmoid sinus openings."
10957234|NCT00840970|FG000|Participant Flow|Pilot 15 mm|First 7 patients (n=7) in the Pilot Phase received 15 mm length splint. This phase used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (15mm length, 220 ug mometasone furoate [MF]) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). 15 mm length splint was not commercialized.
10957235|NCT00840970|FG001|Participant Flow|Efficacy 25 mm|"Efficacy group received the 25mm splint in the Pilot (n=13) and Pivotal Phases (n=25).~Both phases used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (25 mm length, 370 ug MF) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm)."
11178917|NCT02052557|OG000|Outcome|Bupivacaine Liposome Suspension|"exparel 20ml, diluted with 10ml sterile saline for total of 30ml~Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178918|NCT02052557|OG001|Outcome|Bupivacaine|"30 milliliters (ml) of 0.5% marcaine with epinephrine~Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178919|NCT02052557|EG000|Reported Event|Bupivacaine|"30 milliliters (ml) of 0.5% marcaine with epinephrine~Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178920|NCT02052557|EG001|Reported Event|Bupivacaine Liposome Suspension|"exparel 20ml, diluted with 10ml sterile saline for total of 30ml~Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR"
11178921|NCT02052596|BG000|Baseline|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
11178922|NCT02052596|BG001|Baseline|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
11178923|NCT02052596|BG002|Baseline|Total|Total of all reporting groups
11178924|NCT02052596|FG000|Participant Flow|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
11178925|NCT02052596|FG001|Participant Flow|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
11178926|NCT02052596|OG000|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
11178927|NCT02052596|OG001|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
11178928|NCT02052596|EG000|Reported Event|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
10957236|NCT00840970|FG002|Participant Flow|Safety/PK 25 mm|Safety/PK group (n=5) used a non-randomized design wherein following FESS a drug-coated splints (25 mm length with 370 ug MF) were placed bilaterally in both ethmoid sinus openings.
10957237|NCT00840970|OG000|Outcome|Pilot 15 mm|First 7 patients (n=7) in the Pilot Phase received 15 mm length splint. This phase used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (15mm length, 220 ug mometasone furoate [MF]) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). 15 mm length splint was not commercialized.
10957238|NCT00840970|OG001|Outcome|Efficacy 25 mm|"Efficacy group received the 25mm splint in the Pilot (n=13) and Pivotal Phases (n=25).~Both phases used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (25 mm length, 370 ug MF) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm)."
10957239|NCT00840970|OG002|Outcome|Safety/PK 25 mm|Safety/PK group (n=5) used a non-randomized design wherein following FESS a drug-coated splints (25 mm length with 370 ug MF) were placed bilaterally in both ethmoid sinus openings.
10957240|NCT00840970|OG000|Outcome|Efficacy (Treatment Arm, 25 mm)|This group includes all ethmoid sinuses that received the 25 mm drug-coated Sinexus intranasal splint in Efficacy (Pilot Phase n=13, Pivotal Phase n=25).
10957241|NCT00840970|OG001|Outcome|Efficacy (Control Arm, 25 mm)|This group includes all ethmoid sinuses that received the 25 mm non-coated Sinexus intranasal splint in Efficacy (Pilot Phase n=13, Pivotal Phase n=25).
10957242|NCT00840970|EG000|Reported Event|Pilot 15 mm|First 7 patients (n=7) in the Pilot Phase received 15 mm length splint. This phase used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (15mm length, 220 ug mometasone furoate [MF]) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). 15 mm length splint was not commercialized.
10957243|NCT00840970|EG001|Reported Event|Efficacy 25 mm|"Efficacy group received the 25mm splint in the Pilot (n=13) and Pivotal Phases (n=25).~Both phases used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (25 mm length, 370 ug MF) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm)."
10957244|NCT00840970|EG002|Reported Event|Safety/PK 25 mm|Safety/PK group (n=5) used a non-randomized design wherein following FESS a drug-coated splints (25 mm length with 370 ug MF) were placed bilaterally in both ethmoid sinus openings.
10957245|NCT00840996|BG000|Baseline|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
11234405|NCT02435069|BG000|Baseline|No Intervention: Pre-operative Baseline Phase|Baseline data including frequency and severity of fecal soiling and frequency and severity of abdominal pain were collected for a minimum of 2 weeks prior to surgical construction of the ACE stoma. Baseline stool calprotectin and serum electrolytes were collected in the baseline phase prior to initiation of the preoperative bowel prep. Pre-operative data served as the control.
10957246|NCT00840996|BG001|Baseline|Placebo|Perioperative equal volume of saline placebo IV infusion
10957247|NCT00840996|BG002|Baseline|Total|Total of all reporting groups
10957248|NCT00840996|FG000|Participant Flow|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
10957249|NCT00840996|FG001|Participant Flow|Placebo|Perioperative equal volume of saline placebo IV infusion
10957250|NCT00840996|OG000|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
10957251|NCT00840996|OG001|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
10957252|NCT00840996|EG000|Reported Event|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
10957253|NCT00840996|EG001|Reported Event|Placebo|Perioperative equal volume of saline placebo IV infusion
10957254|NCT00841087|BG000|Baseline|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
10957255|NCT00841087|BG001|Baseline|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
10957256|NCT00841087|BG002|Baseline|Total|Total of all reporting groups
10957257|NCT00841087|FG000|Participant Flow|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
10957258|NCT00841087|FG001|Participant Flow|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
10957259|NCT00841087|OG000|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
10957260|NCT00841087|OG001|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
10957261|NCT00841087|EG000|Reported Event|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
10957262|NCT00841087|EG001|Reported Event|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
10957263|NCT00841100|BG000|Baseline|All Participants|All participants that was enrolled in the study
10957264|NCT00841100|FG000|Participant Flow|All Participants|"All participants were enrolled into the four arms of the study. The 24-hour component consisted of participants received one dose of Kuvan 20 mg/kg on Day 1 and assessed for Acute 24 hour Kuvan response. The Phase 1 arm consisted of participants who after completion of the acute 24-hour component, enrolled and received Kuvan 20 mg/kg by mouth once daily for 28 consecutive days. The Phase 2 arm consisted of participants in Phase 1 that were not responsive and continued on to Phase 2 of the study. Positive response is defined as a decrease of blood phenylalanine of 30% or greater from baseline taken from morning blood serum. The Phase 2 component of the study will be a 2 week period of dietary restriction.~The Phase 3 arm of the study consisted of participants in Phase 2 that achieved a fasting blood phenylalanine of less than 600 umol/l after 2-week dietary restriction will be retreated with Kuvan 20 mg/kg by mouth once daily for a period of 28 consecutive days."
10957265|NCT00841100|OG000|Outcome|Ove.Erall Participants|All participants enrolled in the study.
10957266|NCT00841100|EG000|Reported Event|All Participants|All participants that was enrolled in the study
10957267|NCT00841204|BG000|Baseline|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
10957268|NCT00841204|BG001|Baseline|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
10957269|NCT00841204|BG002|Baseline|Total|Total of all reporting groups
11178929|NCT02052596|EG001|Reported Event|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
11178930|NCT02052635|BG000|Baseline|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
10957270|NCT00841204|FG000|Participant Flow|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
10957271|NCT00841204|FG001|Participant Flow|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
10957272|NCT00841204|OG000|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
10957273|NCT00841204|OG001|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
10957274|NCT00841204|OG000|Outcome|Arm I|"Participants receive oral sulindac twice daily for 8 weeks~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
10957275|NCT00841204|OG001|Outcome|Arm II|"Participants receive oral placebo twice daily for 8 weeks~placebo: Inactive agent~laboratory biomarker analysis: Correlative studies"
10957276|NCT00841204|EG000|Reported Event|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
10957277|NCT00841204|EG001|Reported Event|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
10957278|NCT00841269|BG000|Baseline|Open Label Uridine Treatment|All participants were Caucasian. There were 5 female participants and 2 male participants.
10957279|NCT00841269|BG001|Baseline|Healthy Comparison|Participants assigned to this group were seen only at baseline and received no intervention.
10957280|NCT00841269|BG002|Baseline|Total|Total of all reporting groups
10957281|NCT00841269|FG000|Participant Flow|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks. At each treatment visit, the following rating scales were administered: The CDRS-R, YMRS, and the Columbia-Suicide Severity Rating Scale (C-SSRS)
10957282|NCT00841269|FG001|Participant Flow|Healthy Comparison|Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention.
10957283|NCT00841269|OG000|Outcome|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks.
11178931|NCT02052635|BG001|Baseline|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
11178932|NCT02052635|BG002|Baseline|Total|Total of all reporting groups
11178933|NCT02052635|FG000|Participant Flow|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
11178934|NCT02052635|FG001|Participant Flow|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
11178935|NCT02052635|OG000|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
11178936|NCT02052635|OG001|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
11178937|NCT02052635|EG000|Reported Event|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
10957284|NCT00841269|OG001|Outcome|Healthy Comparison|Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention/treatment.
10957285|NCT00841269|EG000|Reported Event|Uridine 500 mg by Mouth Twice Daily for 6 Weeks|Because this was an open-label study, all participants received the investigational drug uridine.
10957286|NCT00841321|BG000|Baseline|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
10957287|NCT00841321|BG001|Baseline|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
10957288|NCT00841321|BG002|Baseline|Total|Total of all reporting groups
10957289|NCT00841321|FG000|Participant Flow|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
10957290|NCT00841321|FG001|Participant Flow|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
10957291|NCT00841321|OG000|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
10957292|NCT00841321|OG001|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
10957293|NCT00841321|OG002|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
10957294|NCT00841321|OG003|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
10957295|NCT00841321|EG000|Reported Event|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
11178938|NCT02052635|EG001|Reported Event|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
11178939|NCT02052661|BG000|Baseline|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
11178940|NCT02052661|FG000|Participant Flow|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
11178941|NCT02052661|OG000|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
11178942|NCT02052661|EG000|Reported Event|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
11178943|NCT02052752|BG000|Baseline|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178944|NCT02052752|BG001|Baseline|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178945|NCT02052752|BG002|Baseline|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178946|NCT02052752|BG003|Baseline|Total|Total of all reporting groups
11178947|NCT02052752|FG000|Participant Flow|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178948|NCT02052752|FG001|Participant Flow|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
10957296|NCT00841321|EG001|Reported Event|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
10957297|NCT00841412|BG000|Baseline|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
10957298|NCT00841412|FG000|Participant Flow|Immediate Intervention Group/Units|Immediate Intervention units received a staff training and management intervention to improve daily nutritional care processes.
10957299|NCT00841412|FG001|Participant Flow|Delayed Intervention Group/Units|Delayed Intervention units (control group) was monitored by research staff under usual care conditions.
10957300|NCT00841412|OG000|Outcome|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so outcome measures are reported overall for both groups combined.
10957301|NCT00841412|EG000|Reported Event|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
10957302|NCT00841555|BG000|Baseline|Dose Level 1|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
11178949|NCT02052752|FG002|Participant Flow|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178950|NCT02052752|OG000|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178951|NCT02052752|OG001|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178952|NCT02052752|OG002|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178953|NCT02052752|OG002|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3
11178954|NCT02052752|EG000|Reported Event|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
10957303|NCT00841555|BG001|Baseline|Dose Level 2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957304|NCT00841555|BG002|Baseline|Dose Level 3|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957305|NCT00841555|BG003|Baseline|Total|Total of all reporting groups
10957306|NCT00841555|FG000|Participant Flow|Dose Level 1: 50 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957307|NCT00841555|FG001|Participant Flow|Dose Level 2: 65 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957308|NCT00841555|FG002|Participant Flow|Dose Level 3: 75 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957309|NCT00841555|OG000|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957310|NCT00841555|EG000|Reported Event|50 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957311|NCT00841555|EG001|Reported Event|65 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957312|NCT00841555|EG002|Reported Event|75 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
10957313|NCT00841568|BG000|Baseline|OPC-41061|Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
10957314|NCT00841568|FG000|Participant Flow|OPC-41061|Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
11178955|NCT02052752|EG001|Reported Event|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178956|NCT02052752|EG002|Reported Event|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
11178957|NCT02052895|BG000|Baseline|Sepsis/SIRS|Patients with sepsis or SIRS
11178958|NCT02052895|BG001|Baseline|Control|Patients without SIRS, sepsis, or end stage renal disease
11178959|NCT02052895|BG002|Baseline|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
11178960|NCT02052895|BG003|Baseline|Total|Total of all reporting groups
11178961|NCT02052895|FG000|Participant Flow|Sepsis/SIRS|Patients with sepsis or SIRS
11178962|NCT02052895|FG001|Participant Flow|Control|Patients without SIRS, sepsis, or end stage renal disease
11178963|NCT02052895|FG002|Participant Flow|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
11178964|NCT02052895|OG000|Outcome|Presepsin|ROC-AUC of presepsin for discriminating between Sepsis and SIRS
11178965|NCT02052895|OG001|Outcome|Procalcitonin|ROC-AUC of procalcitonin for discriminating between Sepsis and SIRS
11178966|NCT02052895|EG000|Reported Event|Sepsis/SIRS|Patients with sepsis or SIRS
11178967|NCT02052895|EG001|Reported Event|Control|Patients without SIRS, sepsis, or end stage renal disease
11178968|NCT02052895|EG002|Reported Event|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
10957315|NCT00841568|OG000|Outcome|Baseline|"Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.~Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period."
10957316|NCT00841568|OG001|Outcome|Week 24|"Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.~Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period."
10957317|NCT00841568|OG002|Outcome|Week 52|"Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.~Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period."
10957318|NCT00841568|OG003|Outcome|Week 104|"Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.~Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period."
10957319|NCT00841568|OG004|Outcome|Week 156|"Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.~Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period."
10957320|NCT00841568|EG000|Reported Event|OPC-41061|Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
10957321|NCT00841672|BG000|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
10957322|NCT00841672|BG001|Baseline|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
10957323|NCT00841672|BG002|Baseline|Total|Total of all reporting groups
10957324|NCT00841672|FG000|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
10957325|NCT00841672|FG001|Participant Flow|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
10957326|NCT00841672|OG000|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
10957327|NCT00841672|OG001|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
10957328|NCT00841672|EG000|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
10957329|NCT00841672|EG001|Reported Event|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
10957330|NCT00841763|BG000|Baseline|TIV + aH5N1|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957331|NCT00841763|BG001|Baseline|PL+ aTIV|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957332|NCT00841763|BG002|Baseline|Total|Total of all reporting groups
10957333|NCT00841763|FG000|Participant Flow|TIV + aH5N1 (18-60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957334|NCT00841763|FG001|Participant Flow|PL+ aTIV (18-60 Yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957335|NCT00841763|FG002|Participant Flow|TIV + aH5N1 (>60 Yrs)|First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).
10957336|NCT00841763|FG003|Participant Flow|PL+ aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957337|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957338|NCT00841763|OG001|Outcome|PL+ aTIV (18-60 Yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957339|NCT00841763|OG002|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).
10957340|NCT00841763|OG003|Outcome|PL+ aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957341|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1)
10957342|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957343|NCT00841763|OG002|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957344|NCT00841763|OG003|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957345|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957346|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957347|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957348|NCT00841763|OG002|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957349|NCT00841763|OG003|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957350|NCT00841763|OG004|Outcome|TIV + aH5N1 (18-60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957351|NCT00841763|OG005|Outcome|TIV + aH5N1 (>60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957352|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957353|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957354|NCT00841763|OG002|Outcome|TIV + H5N1 (18-60 Yrs) SRH Areas ≥ 25mm^2|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic vaccine (aH5N1).
10957355|NCT00841763|OG003|Outcome|TIV + aH5N1 (>60 Yrs) SRH Areas ≥ 25mm^2|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957356|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957357|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (H5N1).
10957358|NCT00841763|OG002|Outcome|TIV + aH5N1 (18-60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957359|NCT00841763|OG003|Outcome|TIV + aH5N1 (>60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957360|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957361|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957362|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957363|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957364|NCT00841763|OG004|Outcome|TIV + aH5N1 (18-60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
11178969|NCT02052960|BG000|Baseline|CetuGEX™ Plus Chemotherapy|"720 mg weekly administration~CetuGEX™: 60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration~Chemotherapy: Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)"
10957365|NCT00841763|OG005|Outcome|TIV + aH5N1 (>60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1).
10957366|NCT00841763|OG002|Outcome|TIV + aH5N1 (18-60 Yrs) SRH Areas ≥ 25mm^2|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957367|NCT00841763|OG003|Outcome|TIV + aH5N1 (>60 Yrs) SRH Areas≥ 25mm^2|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957368|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957369|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957370|NCT00841763|OG002|Outcome|TIV + aH5N1 (18-60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957371|NCT00841763|OG003|Outcome|TIV + aH5N1 (>60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957372|NCT00841763|OG001|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).
10957373|NCT00841763|OG000|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1)
10957374|NCT00841763|OG001|Outcome|PL + aTIV (18-60 Yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957375|NCT00841763|OG003|Outcome|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957376|NCT00841763|EG000|Reported Event|TIV + aH5N1 (18-60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
10957377|NCT00841763|EG001|Reported Event|PL + aTIV (18-60 Yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957378|NCT00841763|EG002|Reported Event|TIV + aH5N1 (>60 Yrs)|First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).
10957379|NCT00841763|EG003|Reported Event|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
10957380|NCT00841776|BG000|Baseline|Duac|Clindamycin and benzoyl peroxide topical gel
10957381|NCT00841776|BG001|Baseline|Ziana|Clindamycin and topical tretinoin gel
10957382|NCT00841776|BG002|Baseline|Total|Total of all reporting groups
10957383|NCT00841776|FG000|Participant Flow|Duac|Clindamycin and benzoyl peroxide topical gel
10957384|NCT00841776|FG001|Participant Flow|Ziana|Clindamycin and topical tretinoin gel
10957385|NCT00841776|OG000|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
10957386|NCT00841776|OG001|Outcome|Ziana|Clindamycin and topical tretinoin gel
10957387|NCT00841776|EG000|Reported Event|Duac|Clindamycin and benzoyl peroxide topical gel
10957388|NCT00841776|EG001|Reported Event|Ziana|Clindamycin and topical tretinoin gel
10957389|NCT00841828|BG000|Baseline|Arm 1: EC -> D + Lapatinib|"Epirubicin and Cyclophosphamide (EC) followed by Docetaxel (D) and Lapatinib~Drugs plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles followed by Docetaxel and Lapatinib each 21 days for 4 cycles"
10957390|NCT00841828|BG001|Baseline|Arm 2: EC -> D + Trastuzumab|"Epirubicin and Cyclophosphamide (EC) followed by Docetaxel (D) and Trastuzumab~Drug plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles followed by Docetaxel and Trastuzumab each 21 days for 4 cycles"
10957391|NCT00841828|BG002|Baseline|Total|Total of all reporting groups
10957392|NCT00841828|FG000|Participant Flow|Arm 1: EC -> D + Lapatinib|"EC -> D + Lapatinib~Drugs plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel + Lapatinib each 21 days for 4 cycles"
10957393|NCT00841828|FG001|Participant Flow|Arm 2: EC -> D + Trastuzumab|"EC -> D + Trastuzumab~Drug plus Biological~EC each 21 days for 4 cycles -> Docetaxel + Trastuzumab each 21 days for 4 cycles"
10957394|NCT00841828|OG000|Outcome|Arm 1: EC -> D + Lapatinib|"EC -> D + Lapatinib~Drugs plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles)"
10957395|NCT00841828|OG001|Outcome|Arm 2: EC -> D + Trastuzumab|"EC -> D + Trastuzumab~Drug plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles"
10957396|NCT00841828|OG000|Outcome|Arm 1: EC -> D + Lapatinib|"EC -> D + Lapatinib~Drugs plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles"
10957397|NCT00841828|OG001|Outcome|Arm 2: EC -> D + Trastuzumab|"EC -> D + Trastuzumab~Drug plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel + Trastuzumab each 21 days for 4 cycles"
10957398|NCT00841828|EG000|Reported Event|Arm 1: EC -> D + Lapatinib|"EC -> D + Lapatinib~Drugs plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles)"
10957399|NCT00841828|EG001|Reported Event|Arm 2: EC -> D + Trastuzumab|"EC -> D + Trastuzumab~Drug plus Biological~Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles"
10957400|NCT00841906|BG000|Baseline|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
10957401|NCT00841906|BG001|Baseline|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
10957402|NCT00841906|BG002|Baseline|Total|Total of all reporting groups
10957403|NCT00841906|FG000|Participant Flow|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
10963783|NCT00874237|OG000|Outcome|Oral Moxifloxacin vs Placebo Crossover Subjects|"Largest lower 95% Upper Confidence Bound (msec) for moxifloxacin QTcI Differences from Placebo in Change from Predose Baseline~Lower CI > 5 msec at 1 or more time points establishes sensitivity of the QTc assay for the study"
10963784|NCT00874237|EG000|Reported Event|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg single dose Oral placebo~Inhaled loxapine: Inhaled Staccato Loxapine 10 mg single dose~Oral placebo: Oral placebo"
10963785|NCT00874237|EG001|Reported Event|Placebo|"Inhaled Staccato placebo single dose Oral placebo~Inhaled placebo: Inhaled Staccato placebo single dose~Oral placebo: Oral placebo"
10957404|NCT00841906|FG001|Participant Flow|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
10957405|NCT00841906|OG000|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
10957406|NCT00841906|OG001|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
10957407|NCT00841906|OG000|Outcome|Alice PDx at Home|All participants set up the Alice PDx at home and in the lab. This is evaluating the Good Study Indicator (GSI) at home.
10957408|NCT00841906|OG001|Outcome|Alice PDx in the Lab|All participants set up the Alice PDx at home and in the lab. This is evaluating the Good Study Indicator (GSI) in the lab.
10957409|NCT00841906|EG000|Reported Event|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
10957410|NCT00841906|EG001|Reported Event|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
10957411|NCT00841971|BG000|Baseline|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
10957412|NCT00841971|BG001|Baseline|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
10957413|NCT00841971|BG002|Baseline|Total|Total of all reporting groups
10957414|NCT00841971|FG000|Participant Flow|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
11178970|NCT02052960|BG001|Baseline|Cetuximab Plus Chemotherapy|"250 mg/m2 weekly administration~Cetuximab: 400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration~Chemotherapy: Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)"
10957415|NCT00841971|FG001|Participant Flow|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
10957416|NCT00841971|OG000|Outcome|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
10957417|NCT00841971|OG001|Outcome|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
11178971|NCT02052960|BG002|Baseline|Total|Total of all reporting groups
10957418|NCT00841971|EG000|Reported Event|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
10957419|NCT00841971|EG001|Reported Event|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
11341767|NCT03687827|EG001|Reported Event|Insulin Glargine 100U/mL|Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
10957420|NCT00842023|BG000|Baseline|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
10957421|NCT00842023|BG001|Baseline|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
10957422|NCT00842023|BG002|Baseline|Total|Total of all reporting groups
10957423|NCT00842023|FG000|Participant Flow|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
10957424|NCT00842023|FG001|Participant Flow|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
10957425|NCT00842023|OG000|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
10957426|NCT00842023|OG001|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment
10957427|NCT00842023|OG000|Outcome|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
10957428|NCT00842023|OG001|Outcome|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
10957429|NCT00842023|OG001|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
10957430|NCT00842023|EG000|Reported Event|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
10957431|NCT00842023|EG001|Reported Event|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
10957432|NCT00842075|BG000|Baseline|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
10957433|NCT00842075|BG001|Baseline|2 Usual Regimen|Usual bolus insulin dose at each meal
10957434|NCT00842075|BG002|Baseline|Total|Total of all reporting groups
10957435|NCT00842075|FG000|Participant Flow|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
10957436|NCT00842075|FG001|Participant Flow|2 Usual Regimen|Usual bolus insulin dose at each meal
10957437|NCT00842075|OG000|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
10957438|NCT00842075|OG001|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
10957439|NCT00842075|EG000|Reported Event|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
10957440|NCT00842075|EG001|Reported Event|2 Usual Regimen|Usual bolus insulin dose at each meal
10957441|NCT00842153|BG000|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
10957442|NCT00842153|BG001|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
10957443|NCT00842153|BG002|Baseline|Total|Total of all reporting groups
10957444|NCT00842153|FG000|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
10957445|NCT00842153|FG001|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
10957446|NCT00842153|OG000|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
10957447|NCT00842153|OG001|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
10957448|NCT00842153|EG000|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
10957449|NCT00842153|EG001|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
10957450|NCT00842231|BG000|Baseline|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
10957451|NCT00842231|FG000|Participant Flow|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
10957452|NCT00842231|OG000|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
10957453|NCT00842231|EG000|Reported Event|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
10957454|NCT00842244|BG000|Baseline|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
10957455|NCT00842244|FG000|Participant Flow|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
10957456|NCT00842244|OG000|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
10957457|NCT00842244|OG000|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
10957458|NCT00842244|OG000|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
10963786|NCT00874237|EG002|Reported Event|Oral Moxifloxacin|"Inhaled Staccato placebo single dose Oral moxifloxacin 400 mg~Inhaled placebo: Inhaled Staccato placebo single dose~Oral moxifloxacin: Oral Moxifloxacin 400 mg"
10963787|NCT00874250|BG000|Baseline|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
11341768|NCT03687970|BG000|Baseline|Group A: Painful CIPN Group|Patients after chemotherapy with painful neuropathy
10957459|NCT00842244|OG000|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
10957460|NCT00842244|EG000|Reported Event|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
10957461|NCT00842257|BG000|Baseline|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
10957462|NCT00842257|FG000|Participant Flow|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
10957463|NCT00842257|OG000|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
10957464|NCT00842257|EG000|Reported Event|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
10957465|NCT00842296|BG000|Baseline|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter.
10957466|NCT00842296|FG000|Participant Flow|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
10957467|NCT00842296|OG000|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
10957468|NCT00842296|EG000|Reported Event|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
10957469|NCT00842309|BG000|Baseline|D-cycloserine|"100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.~d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks."
10957470|NCT00842309|BG001|Baseline|Placebo|"Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.~Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks."
10957471|NCT00842309|BG002|Baseline|Total|Total of all reporting groups
10957472|NCT00842309|FG000|Participant Flow|D-cycloserine-augmented CBT|"100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.~d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks."
10957473|NCT00842309|FG001|Participant Flow|Placebo-augmented CBT|"Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.~Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks."
10957474|NCT00842309|OG000|Outcome|D-cycloserine|"100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.~d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks."
10957475|NCT00842309|OG001|Outcome|Placebo|"Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.~Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks."
10957476|NCT00842309|EG000|Reported Event|D-cycloserine-augmented CBT|"100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.~d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks."
10957477|NCT00842309|EG001|Reported Event|Placebo-augmented CBT|"Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.~Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks."
11341769|NCT03687970|BG001|Baseline|Group B: Control Group|Patients after chemotherapy without painful neuropathy
10957478|NCT00842335|BG000|Baseline|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
10957479|NCT00842335|FG000|Participant Flow|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
10957480|NCT00842335|OG000|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
10957481|NCT00842335|OG000|Outcome|All Subjects|"The starting dose of JI-101 for patients in the first cohort was 100 mg QD. All patients took JI-101 without food on Day 0, with a high fat meal on Day 2, and with a regular diet on Day 3 onwards. Patients in the first three cohorts were dosed QD. Based on PK characteristics observed from the first eight patients (Cohort 1, Cohort 2, and Cohort 3), subsequent cohorts were dosed BID.~After the first eight patients, the combined PK profiles of the enrolled patients were studied. These assessments indicated that the PK profile for JI-101 supported BID dosing. Therefore, BID dosing was administered to patients who enrolled in the study following the effective date of Protocol"
10957482|NCT00842335|OG000|Outcome|All Subjects|
10957483|NCT00842335|EG000|Reported Event|JI-101|Maximum tolerated dose
10957484|NCT00842348|BG000|Baseline|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
10957485|NCT00842348|BG001|Baseline|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
10957486|NCT00842348|BG002|Baseline|Total|Total of all reporting groups
10957487|NCT00842348|FG000|Participant Flow|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding double blind (DB) study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
10957488|NCT00842348|FG001|Participant Flow|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
10957489|NCT00842348|OG000|Outcome|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
10957490|NCT00842348|OG001|Outcome|Placebo|Patients who received placebo in the preceding double DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
10957491|NCT00842348|OG002|Outcome|Total|All patients treated with Lanreotide 120 mg (Autogel formulation) in the open label study.
10957492|NCT00842348|OG000|Outcome|Lanreotide Autogel - Randomised Treatment in Study 726|All patients randomised to lanreotide 120 mg (Autogel formulation) in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
10957493|NCT00842348|OG001|Outcome|Placebo - Randomised Treatment in Study 726|All patients randomised to placebo in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
10957494|NCT00842348|EG000|Reported Event|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
10957495|NCT00842348|EG001|Reported Event|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
10957496|NCT00842348|EG002|Reported Event|Total|All patients treated with lanreotide 120 mg (Autogel formulation) in the open label study.
10957497|NCT00842361|BG000|Baseline|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
10957498|NCT00842361|BG001|Baseline|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
10957499|NCT00842361|BG002|Baseline|Total|Total of all reporting groups
10957500|NCT00842361|FG000|Participant Flow|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
11234406|NCT02435069|FG000|Participant Flow|No Intervention: Pre-operative Baseline Phase|Baseline data including frequency and severity of fecal soiling and frequency and severity of abdominal pain were collected for a minimum of 2 weeks prior to surgical construction of the ACE stoma. Baseline stool calprotectin and serum electrolytes were collected in the baseline phase prior to initiation of the preoperative bowel prep. Pre-operative data served as the control.
10957501|NCT00842361|FG001|Participant Flow|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
10957502|NCT00842361|OG000|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
10957503|NCT00842361|OG001|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
10957504|NCT00842361|EG000|Reported Event|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
10957505|NCT00842361|EG001|Reported Event|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
10957506|NCT00842543|BG000|Baseline|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
10957507|NCT00842543|BG001|Baseline|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
10957508|NCT00842543|BG002|Baseline|Overweight Placebo|Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
10957509|NCT00842543|BG003|Baseline|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
10957510|NCT00842543|BG004|Baseline|Total|Total of all reporting groups
10957511|NCT00842543|FG000|Participant Flow|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
10957512|NCT00842543|FG001|Participant Flow|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
10957513|NCT00842543|FG002|Participant Flow|Overweight Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
10957514|NCT00842543|FG003|Participant Flow|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months
10957515|NCT00842543|OG000|Outcome|Overweight|Overweight boys prior to receiving intervention.
10957516|NCT00842543|OG001|Outcome|Lean|Lean boys prior to receiving intervention.
10957517|NCT00842543|OG000|Outcome|Overweight FVJC|Results displayed for overweight boys who received 6 months of FVJC intervention
10957518|NCT00842543|OG001|Outcome|Lean FVJC|
10957519|NCT00842543|OG002|Outcome|Overweight Placebo|Reesults displayed for overweight boys who received 6 months of Placebo intervention
10957520|NCT00842543|OG003|Outcome|Lean Placebo|
10957521|NCT00842543|EG000|Reported Event|Overweight FVJC|Overweight Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
10957522|NCT00842543|EG001|Reported Event|Lean FVJC|Lean Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
10957523|NCT00842543|EG002|Reported Event|Overweight Placebo|Overweight Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
10957524|NCT00842543|EG003|Reported Event|Lean Placebo|Lean Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
10957525|NCT00842608|BG000|Baseline|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
10957526|NCT00842608|BG001|Baseline|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
10957527|NCT00842608|BG002|Baseline|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
10957528|NCT00842608|BG003|Baseline|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
10957529|NCT00842608|BG004|Baseline|Total|Total of all reporting groups
10957530|NCT00842608|FG000|Participant Flow|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
10957531|NCT00842608|FG001|Participant Flow|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
10963788|NCT00874250|FG000|Participant Flow|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
10963789|NCT00874250|OG000|Outcome|CTAG Device Aneurysym Subjects|
10963790|NCT00874250|OG000|Outcome|GORE CTAG Device|GORE CTAG Device: Endovascular aortic stent-graft
10957532|NCT00842608|FG002|Participant Flow|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
10957533|NCT00842608|FG003|Participant Flow|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
10957534|NCT00842608|OG000|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
10957535|NCT00842608|OG001|Outcome|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
10957536|NCT00842608|OG002|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
10957537|NCT00842608|OG003|Outcome|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
10957538|NCT00842608|EG000|Reported Event|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
10957539|NCT00842608|EG001|Reported Event|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
10957540|NCT00842608|EG002|Reported Event|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
10957541|NCT00842608|EG003|Reported Event|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
10957542|NCT00842712|BG000|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957543|NCT00842712|BG001|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
11178972|NCT02052960|FG000|Participant Flow|CetuGEX in Combination With Chemotherapy|CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of CetuGEX.
11341770|NCT03687970|BG002|Baseline|Total|Total of all reporting groups
10957544|NCT00842712|BG002|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957545|NCT00842712|BG003|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957546|NCT00842712|BG004|Baseline|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957547|NCT00842712|BG005|Baseline|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957548|NCT00842712|BG006|Baseline|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957549|NCT00842712|BG007|Baseline|Total|Total of all reporting groups
10957550|NCT00842712|FG000|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957551|NCT00842712|FG001|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
11178973|NCT02052960|FG001|Participant Flow|Cetuximab in Combination With Chemotherapy|Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of cetuximab.
11178974|NCT02052960|OG000|Outcome|CetuGEX|CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
10957552|NCT00842712|FG002|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957553|NCT00842712|FG003|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957554|NCT00842712|FG004|Participant Flow|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10963791|NCT00874250|EG000|Reported Event|CTAG Device Aneurysm Subjects|
11178975|NCT02052960|OG001|Outcome|Cetuximab|Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
11178976|NCT02052960|OG000|Outcome|CetuGEX|CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly.
11178977|NCT02052960|OG000|Outcome|CetuGEX in Combination With Chemotherapy|CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of CetuGEX.
11341771|NCT03687970|FG000|Participant Flow|Group A: Painful Neuropathy Group|Patient with painful neuropathy after receiving treatment with oxaliplatin, cisplatin, paclitaxel or docetaxel
10957555|NCT00842712|FG005|Participant Flow|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957556|NCT00842712|FG006|Participant Flow|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957557|NCT00842712|OG000|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957558|NCT00842712|OG001|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957559|NCT00842712|OG002|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957560|NCT00842712|OG003|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957561|NCT00842712|OG000|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957562|NCT00842712|OG001|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957563|NCT00842712|OG002|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957564|NCT00842712|EG000|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957565|NCT00842712|EG001|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
10957566|NCT00842712|EG002|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
11178978|NCT02052960|OG001|Outcome|Cetuximab in Combination With Chemotherapy|Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of cetuximab.
10957567|NCT00842712|EG003|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
11341772|NCT03687970|FG001|Participant Flow|Group B: Control Group|Patient with no painful CIPN after receiving treatment with ...
10957568|NCT00842712|EG004|Reported Event|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957569|NCT00842712|EG005|Reported Event|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957570|NCT00842712|EG006|Reported Event|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
10957571|NCT00842751|BG000|Baseline|All Study Participants|
10957572|NCT00842751|FG000|Participant Flow|Acyline + Testosterone Undecanoate + Placebo Finasteride|Acyline 300 mcg/kg +Testosterone Undecanoate 200 mg, BID orally + placebo finasteride
10957573|NCT00842751|OG000|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + Placebo Finasteride
10957574|NCT00842751|OG001|Outcome|Acyline +Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5 mg, BID orally
10957575|NCT00842751|OG002|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 1 mg, BID orally
10957576|NCT00842751|OG000|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg subcutaneous (SC) +Testosterone Undecanoate 200 mg, BID orally + Placebo finasteride
10957577|NCT00842751|OG001|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
10957578|NCT00842751|OG002|Outcome|Acyline + Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
10957579|NCT00842751|OG000|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, twice daily (BID) orally + placebo finasteride
10957580|NCT00842751|OG002|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
10957581|NCT00842751|EG000|Reported Event|First Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily, orally + Finasteride placebo, twice daily, orally
10957582|NCT00842751|EG001|Reported Event|Second Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5mg, twice a day, orally
10957583|NCT00842751|EG002|Reported Event|Third Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily orally + Finasteride 1mg, twice a day, orally
10957584|NCT00842764|BG000|Baseline|Holmium:YAG Laser|Minimally Invasive Holmium:YAG laser Blepharoplasty
10957585|NCT00842764|FG000|Participant Flow|Holmium:YAG Laser|Subjects with minimally Invasive Holmium:YAG laser Blepharoplasty
10957586|NCT00842764|OG000|Outcome|Holmium:YAG Laser|Subjects with minimally Invasive Holmium:YAG laser Blepharoplasty
10957587|NCT00842764|EG000|Reported Event|Holmium:YAG Laser|Subjects with Minimally Invasive Holmium:YAG laser Blepharoplasty
10957588|NCT00842829|BG000|Baseline|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
10957589|NCT00842829|BG001|Baseline|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
10957590|NCT00842829|BG002|Baseline|Total|Total of all reporting groups
10957591|NCT00842829|FG000|Participant Flow|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
10957592|NCT00842829|FG001|Participant Flow|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
10957593|NCT00842829|FG002|Participant Flow|FBT - Treatment and Continuation Periods|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
10957594|NCT00842829|OG000|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
10957595|NCT00842829|OG001|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
10957596|NCT00842829|OG000|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
10957597|NCT00842829|OG000|Outcome|During Titration Period|The titration period consisted of up to 7 days of treatment in which participants used increasing dosage of study drug in order to identify the effective dose for their breakthrough pain episodes.
10957598|NCT00842829|OG001|Outcome|During Treatment Period|The treatment period included participants who identified an effective dose during the earlier study period and used that dose for BTP episodes during the Treatment Period.
10957599|NCT00842829|OG000|Outcome|30 Minutes|Participant assessments of medication performance 30 minutes after dosing during the Treatment Period.
10957600|NCT00842829|OG001|Outcome|60 Minutes|Participant assessments of medication performance 60 minutes after dosing during the Treatment Period.
10957601|NCT00842829|OG002|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
10957602|NCT00842829|OG003|Outcome|FBT - Continuation Period|The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
10957603|NCT00842829|EG000|Reported Event|FBT - All Doses and Study Periods|Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg
10957604|NCT00842946|BG000|Baseline|Acceptance|Behavioral exposure within the context of psychological acceptance.
10957605|NCT00842946|BG001|Baseline|Habituation|Behavioral exposure within the context of habituation.
10957606|NCT00842946|BG002|Baseline|Total|Total of all reporting groups
10957607|NCT00842946|FG000|Participant Flow|Acceptance|Behavioral exposure within the context of psychological acceptance.
10957608|NCT00842946|FG001|Participant Flow|Habituation|Behavioral exposure within the context of habituation.
10957609|NCT00842946|OG000|Outcome|Acceptance|Behavioral exposure within the context of psychological acceptance.
10957610|NCT00842946|OG001|Outcome|Habituation|Behavioral exposure within the context of habituation.
10957611|NCT00842946|EG000|Reported Event|Acceptance|Behavioral exposure within the context of psychological acceptance.
10957612|NCT00842946|EG001|Reported Event|Habituation|Behavioral exposure within the context of habituation.
10957613|NCT00842985|BG000|Baseline|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
10957614|NCT00842985|FG000|Participant Flow|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
10957615|NCT00842985|OG000|Outcome|THC+Modafinil|Session where THC+Modafinil was given.
10957616|NCT00842985|OG001|Outcome|THC+Placebo|Session where TCH and Placebo Modafinil were given
10957617|NCT00842985|OG002|Outcome|Pla+Modafinil|Session where Placebo THC and Modafinil were given
10957618|NCT00842985|OG003|Outcome|Placebo+Placebo|Session where placebo THC and Placebo Modafinil were given.
10957619|NCT00842985|EG000|Reported Event|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
10957620|NCT00843024|BG000|Baseline|Placebo|A single matching placebo tablet taken within a 12-week period
10957621|NCT00843024|BG001|Baseline|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
10957622|NCT00843024|BG002|Baseline|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
10957623|NCT00843024|BG003|Baseline|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
10957624|NCT00843024|BG004|Baseline|Total|Total of all reporting groups
10957625|NCT00843024|FG000|Participant Flow|12 to 14 Years Age Group: Single-blind Phase|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
10957626|NCT00843024|FG001|Participant Flow|15 to 17 Years Age Group: Single-blind Phase|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
10957627|NCT00843024|FG002|Participant Flow|Placebo|After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period
10957628|NCT00843024|FG003|Participant Flow|Sumatriptan 10 mg/ Naproxen 60 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
10957629|NCT00843024|FG004|Participant Flow|Sumatriptan 30 mg/ Naproxen 180 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
10957630|NCT00843024|FG005|Participant Flow|Sumatriptan 85 mg/ Naproxen 500 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
10957631|NCT00843024|OG000|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
10957632|NCT00843024|OG001|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
10957633|NCT00843024|OG002|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
10957634|NCT00843024|OG003|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
10957635|NCT00843024|OG000|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
10957636|NCT00843024|OG001|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
10957637|NCT00843024|EG000|Reported Event|Placebo|A single matching double-blind placebo tablet taken within a 12-week period
10957638|NCT00843024|EG001|Reported Event|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
10957639|NCT00843024|EG002|Reported Event|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
10957640|NCT00843024|EG003|Reported Event|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
10957641|NCT00843024|EG004|Reported Event|Single-blind Run-In Phase Placebo|One tablet of single-blind placebo taken during the Run-In Phase
10957642|NCT00843115|BG000|Baseline|Donepezil|As per physician prescription
10957643|NCT00843115|FG000|Participant Flow|Donepezil|As per physician prescription
10957644|NCT00843115|OG000|Outcome|Donepezil|As per physician prescription
10957645|NCT00843115|EG000|Reported Event|Donepezil|As per physician prescription
10957646|NCT00843167|BG000|Baseline|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
10957647|NCT00843167|BG001|Baseline|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10957648|NCT00843167|BG002|Baseline|Total|Total of all reporting groups
10957649|NCT00843167|FG000|Participant Flow|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
10957650|NCT00843167|FG001|Participant Flow|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10957651|NCT00843167|OG000|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
10957652|NCT00843167|OG001|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10957653|NCT00843167|OG000|Outcome|Benign Tissue; Ki-67|Sulforaphane Supplement = 23, Placebo = 25
10957654|NCT00843167|OG001|Outcome|DCIS Tissue; Ki-67|Sulforaphane Supplement= 6, Placebo = 13
10957655|NCT00843167|OG002|Outcome|Invasive Ductal Carcinoma Tissue; Ki-67|Sulforaphane Supplement= 7, Placebo= 6
10957656|NCT00843167|OG001|Outcome|Treatment|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10957657|NCT00843167|EG000|Reported Event|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
10957658|NCT00843167|EG001|Reported Event|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
10957659|NCT00843180|BG000|Baseline|Massage|massage and acupressure up to 3x/week for entire hospital stay
10957660|NCT00843180|BG001|Baseline|Control|usual care only as control arm hospital care during bone marrow transplant
10957661|NCT00843180|BG002|Baseline|Total|Total of all reporting groups
10957662|NCT00843180|FG000|Participant Flow|Massage|massage and acupressure up to 3x/week for entire hospital stay
10957663|NCT00843180|FG001|Participant Flow|Control|usual care only as control arm hospital care during bone marrow transplant
10957664|NCT00843180|OG000|Outcome|Massage|
10957665|NCT00843180|OG001|Outcome|Control|
10957666|NCT00843180|EG000|Reported Event|Massage|massage and acupressure up to 3x/week for entire hospital stay
10957667|NCT00843180|EG001|Reported Event|Control|usual care only as control arm hospital care during bone marrow transplant
10957668|NCT00843193|BG000|Baseline|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10957669|NCT00843193|BG001|Baseline|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10957670|NCT00843193|BG002|Baseline|Total|Total of all reporting groups
10957671|NCT00843193|FG000|Participant Flow|Placebo|Participants received a total of three once-monthly intravenous (IV) infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10963792|NCT00874276|BG000|Baseline|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
10957672|NCT00843193|FG001|Participant Flow|GSK679586 10mg (Milligram)/kg(Kilogram)|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/ milliliter (mL). The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10957673|NCT00843193|OG000|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10957674|NCT00843193|OG001|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10957675|NCT00843193|OG000|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10957676|NCT00843193|EG000|Reported Event|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10957677|NCT00843193|EG001|Reported Event|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
10957678|NCT00843284|BG000|Baseline|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
10957679|NCT00843284|FG000|Participant Flow|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
10957680|NCT00843284|OG000|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
10957681|NCT00843284|EG000|Reported Event|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
10957682|NCT00843349|BG000|Baseline|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
10957683|NCT00843349|BG001|Baseline|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
10957684|NCT00843349|BG002|Baseline|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
10957685|NCT00843349|BG003|Baseline|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
11178979|NCT02052960|EG000|Reported Event|CetuGEX|CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
11178980|NCT02052960|EG001|Reported Event|Cetuximab|Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
10957686|NCT00843349|BG004|Baseline|Total|Total of all reporting groups
10957687|NCT00843349|FG000|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate (LC)|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
10957688|NCT00843349|FG001|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
10957689|NCT00843349|FG002|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + Lanthanum Carbonate placebo
10957690|NCT00843349|FG003|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate Placebo|no dietary intervention + Lanthanum Carbonate placebo
10957691|NCT00843349|OG000|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
10957692|NCT00843349|OG001|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
10957693|NCT00843349|OG002|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
10957694|NCT00843349|OG003|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
10957695|NCT00843349|EG000|Reported Event|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
10957696|NCT00843349|EG001|Reported Event|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
10957697|NCT00843349|EG002|Reported Event|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
10957698|NCT00843349|EG003|Reported Event|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
11178981|NCT02053077|BG000|Baseline|Intervention|Diabetes therapy was performed according to the intended use of the GlucoTab system
11178982|NCT02053077|FG000|Participant Flow|Intervention|Diabetes therapy was performed according to the intended use of the GlucoTab system
11178983|NCT02053077|OG000|Outcome|Intervention|Diabetes therapy was performed according to the intended use of the GlucoTab system
11178984|NCT02053077|EG000|Reported Event|Intervention|Diabetes therapy was performed according to the intended use of the GlucoTab system
11178985|NCT02053168|BG000|Baseline|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
10957699|NCT00843466|BG000|Baseline|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
10957700|NCT00843466|BG001|Baseline|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
10957701|NCT00843466|BG002|Baseline|Total|Total of all reporting groups
10957702|NCT00843466|FG000|Participant Flow|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
10957703|NCT00843466|FG001|Participant Flow|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
10957704|NCT00843466|OG000|Outcome|Mild Moisturizing Hand Cleanser Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
10957705|NCT00843466|OG001|Outcome|No Treatment|The control group continued to use their current cleanser for hand washing.
10957706|NCT00843466|EG000|Reported Event|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
10957707|NCT00843466|EG001|Reported Event|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
10957708|NCT00843479|BG000|Baseline|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
10957709|NCT00843479|BG001|Baseline|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
10957710|NCT00843479|BG002|Baseline|Total|Total of all reporting groups
10957711|NCT00843479|FG000|Participant Flow|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
10957712|NCT00843479|FG001|Participant Flow|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
10957713|NCT00843479|OG000|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
10957714|NCT00843479|OG001|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
10957715|NCT00843479|OG000|Outcome|Elderly NGT|Normoglycemic subjects 65-80 years old
10957716|NCT00843479|OG001|Outcome|Middle-age NGT|Middle-age normoglycemic subjects 35 to 50 years old
10957717|NCT00843479|EG000|Reported Event|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
10957718|NCT00843479|EG001|Reported Event|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
10957719|NCT00843492|BG000|Baseline|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
10957720|NCT00843492|BG001|Baseline|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
10957721|NCT00843492|BG002|Baseline|Total|Total of all reporting groups
10957722|NCT00843492|FG000|Participant Flow|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
10957723|NCT00843492|FG001|Participant Flow|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
10957724|NCT00843492|OG000|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
10957725|NCT00843492|OG001|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
10957726|NCT00843492|EG000|Reported Event|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
10957727|NCT00843492|EG001|Reported Event|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
10957728|NCT00843518|BG000|Baseline|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
10957729|NCT00843518|BG001|Baseline|Placebo|Placebo orally twice daily for 12 weeks
10957730|NCT00843518|BG002|Baseline|Total|Total of all reporting groups
10957731|NCT00843518|FG000|Participant Flow|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
10957732|NCT00843518|FG001|Participant Flow|Placebo|Placebo orally twice daily for 12 weeks
10957733|NCT00843518|OG000|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
10957734|NCT00843518|OG001|Outcome|Placebo|Placebo orally twice daily for 12 weeks
10957735|NCT00843518|EG000|Reported Event|LY451395 Acute Treatment|3 milligram (mg) LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate.
10957736|NCT00843518|EG001|Reported Event|Placebo Acute Treatment|Placebo orally twice daily for 12 weeks
10957737|NCT00843518|EG002|Reported Event|LY451395 Washout|A 1-week single-blind washout period after the acute period, during which time all randomized participants received placebo.
10957738|NCT00843518|EG003|Reported Event|Placebo Washout|A 1-week single-blind washout period after the acute period, during time which all randomized participants received placebo.
10957739|NCT00843518|EG004|Reported Event|LY451395 Post-Study|The 30-day period after a participant had taken the last dose of study drug, during which time serious adverse event (SAE) information was collected.
11178986|NCT02053168|FG000|Participant Flow|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
10957740|NCT00843518|EG005|Reported Event|Placebo Post-Study|The 30-day period after a participant had taken the last dose of study drug, during which time serious adverse event (SAE) information was collected.
10957741|NCT00843531|BG000|Baseline|RAD001 and Erlotinib|"everolimus 5 mg daily and continued this throughout the duration of treatment~erlotinib at a dose of 100 mg daily with the option to dose reduce erlotinib to 100 mg daily in the setting of grade 3/4 rash or diarrhea~cycles defined as every 28 days"
10957742|NCT00843531|FG000|Participant Flow|RAD001 and Erlotinib|"RAD001 and erlotinib~Each 28 day cycle:~RAD001: 5 mg per day by mouth (self-administered) Erlotinib: 100 mg per day by mouth (self-administered)"
10957743|NCT00843531|OG000|Outcome|RAD001 Plus Erlotinib|"everolimus 5 mg daily and continued this throughout the duration of treatment~erlotinib at a dose of 100 mg daily with the option to dose reduce erlotinib to 100 mg daily in the setting of grade 3/4 rash or diarrhea~cycles defined as every 28 days"
10957744|NCT00843531|OG000|Outcome|RAD001 and Erlotinib|"Each 28 day cycle:~RAD001: 5 mg per day by mouth (self-administered) Erlotinib: 100 mg per day by mouth (self-administered)~RAD001: 5 mg/day PO (oral)~erlotinib: 100 mg/day (oral)"
10957745|NCT00843531|OG000|Outcome|RAD001 and Erlotinib|"RAD001 and erlotinib~Each 28 day cycle:~RAD001: 5 mg per day by mouth (self-administered) Erlotinib: 100 mg per day by mouth (self-administered)"
10957746|NCT00843531|OG000|Outcome|RAD001 Plus Erlotinib|"RAD001 and erlotinib~Each 28 day cycle:~RAD001: 5 mg per day by mouth (self-administered) Erlotinib: 100 mg per day by mouth (self-administered)"
10957747|NCT00843531|OG000|Outcome|Carcinoid Tumors|"everolimus 5 mg daily and continued this throughout the duration of treatment~erlotinib at a dose of 100 mg daily with the option to dose reduce erlotinib to 100 mg daily in the setting of grade 3/4 rash or diarrhea~cycles defined as every 28 days"
10957748|NCT00843531|EG000|Reported Event|RAD001 Plus Erlotinib|"everolimus 5 mg daily and continued this throughout the duration of treatment~erlotinib at a dose of 100 mg daily with the option to dose reduce erlotinib to 100 mg daily in the setting of grade 3/4 rash or diarrhea~cycles defined as every 28 days"
10957749|NCT00843622|BG000|Baseline|Active Snus|Tobacco-based, smokefree product
10957750|NCT00843622|BG001|Baseline|Placebo Snus|Non-tobacco, non-nicotine placebo product
10957751|NCT00843622|BG002|Baseline|Total|Total of all reporting groups
10957752|NCT00843622|FG000|Participant Flow|Active Snus|Tobacco-based, smokefree product
10957753|NCT00843622|FG001|Participant Flow|Placebo Snus|Non-tobacco, non-nicotine placebo product
10957754|NCT00843622|OG000|Outcome|Active Snus|Tobacco-based, smokefree product
10957755|NCT00843622|OG001|Outcome|Placebo Snus|Non-tobacco, non-nicotine placebo product
11178987|NCT02053168|OG000|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
10957756|NCT00843622|EG000|Reported Event|Active Snus|Tobacco-based, smokefree product
10957757|NCT00843622|EG001|Reported Event|Placebo Snus|Non-tobacco, non-nicotine placebo product
10957758|NCT00843635|BG000|Baseline|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
10957759|NCT00843635|BG001|Baseline|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
10957760|NCT00843635|BG002|Baseline|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
10957761|NCT00843635|BG003|Baseline|Total|Total of all reporting groups
10957762|NCT00843635|FG000|Participant Flow|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
10957763|NCT00843635|FG001|Participant Flow|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
10957764|NCT00843635|FG002|Participant Flow|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
10957765|NCT00843635|OG000|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
10957766|NCT00843635|OG001|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
10957767|NCT00843635|OG002|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
10957768|NCT00843635|OG000|Outcome|Arm A (Tadalafil 10mg) + Arm B (Tadalafil 20mg)|All participants enrolled to the two dosing arms, Arm A (Tadalafil 10 mg) and Arm B (Tadalafil 20 mg).
10957769|NCT00843635|OG000|Outcome|Arm A - 10mg|Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
10957770|NCT00843635|OG001|Outcome|Arm B - Tadalafil 20mg|Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
10957771|NCT00843635|OG002|Outcome|Arm C - Placebo|Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
10957772|NCT00843635|EG000|Reported Event|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
10957773|NCT00843635|EG001|Reported Event|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
10957774|NCT00843635|EG002|Reported Event|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
10963793|NCT00874276|BG001|Baseline|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
11178988|NCT02053168|EG000|Reported Event|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
11178989|NCT02053259|BG000|Baseline|Arm 1|Adaptive with Immediate Rewards
11178990|NCT02053259|BG001|Baseline|Arm 2|Adaptive with Delayed Rewards
11178991|NCT02053259|BG002|Baseline|Arm 3|Static with Immediate Rewards
11178992|NCT02053259|BG003|Baseline|Arm 4|Static with Delayed Non-Contingent Rewards
11178993|NCT02053259|BG004|Baseline|Total|Total of all reporting groups
10957775|NCT00843713|BG000|Baseline|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
10957776|NCT00843713|BG001|Baseline|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
10957777|NCT00843713|BG002|Baseline|Total|Total of all reporting groups
10957778|NCT00843713|FG000|Participant Flow|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
10957779|NCT00843713|FG001|Participant Flow|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
10957780|NCT00843713|OG000|Outcome|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
10957781|NCT00843713|OG001|Outcome|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
10957782|NCT00843713|EG000|Reported Event|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
10957783|NCT00843713|EG001|Reported Event|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
10957784|NCT00843726|BG000|Baseline|1 High-dose Fraction SBRT|"Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).~stereotactic body radiation therapy: Patients undergo 1 high-dose fraction"
10957785|NCT00843726|BG001|Baseline|3 High-dose Fractions SBRT|"Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.~stereotactic body radiation therapy: Patients undergo 3 high-dose fractions"
10957786|NCT00843726|BG002|Baseline|Total|Total of all reporting groups
10957787|NCT00843726|FG000|Participant Flow|1 High-dose Fraction SBRT|"Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).~stereotactic body radiation therapy: Patients undergo 1 high-dose fraction"
10957788|NCT00843726|FG001|Participant Flow|3 High-dose Fractions SBRT|"Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.~stereotactic body radiation therapy: Patients undergo 3 high-dose fractions"
10957789|NCT00843726|OG000|Outcome|I High-dose Fraction SBRT|"Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).~stereotactic body radiation therapy: Patients undergo 1 high-dose fraction"
10957790|NCT00843726|OG001|Outcome|3 High-dose Fractions SBRT|"Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.~stereotactic body radiation therapy: Patients undergo 3 high-dose fractions"
10957791|NCT00843726|OG000|Outcome|1 High-dose Fraction SBRT|"Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).~stereotactic body radiation therapy: Patients undergo 1 high-dose fraction"
10957792|NCT00843726|EG000|Reported Event|1 High-dose Fraction SBRT|"Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).~stereotactic body radiation therapy: Patients undergo 1 high-dose fraction"
10957793|NCT00843726|EG001|Reported Event|3 High-dose Fractions SBRT|"Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.~stereotactic body radiation therapy: Patients undergo 3 high-dose fractions"
10957794|NCT00843778|BG000|Baseline|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
10957795|NCT00843778|FG000|Participant Flow|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
10963794|NCT00874276|BG002|Baseline|Total|Total of all reporting groups
11178994|NCT02053259|FG000|Participant Flow|Adaptive Physical Activity Goals With Immediate Reinforcement|Adaptive Physical Activity Goals with Immediate Reinforcement
11178995|NCT02053259|FG001|Participant Flow|Adaptive Physical Activity Goals With Delayed Reinforcement|Adaptive Physical Activity Goals with Delayed Reinforcement
10957796|NCT00843778|OG000|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
10957797|NCT00843778|EG000|Reported Event|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks."
10957798|NCT00843843|BG000|Baseline|9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
10957799|NCT00843843|BG001|Baseline|3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
10957800|NCT00843843|BG002|Baseline|Total|Total of all reporting groups
10957801|NCT00843843|FG000|Participant Flow|9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days)|9 hour sleep (3days), then 3 hour nap and 6 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
10957802|NCT00843843|FG001|Participant Flow|3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days)|3 hour nap and 6 hour sleep (3days), then 9 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
10957803|NCT00843843|OG000|Outcome|9 Hour Sleep|
10957804|NCT00843843|OG001|Outcome|3 Hour Nap and 6 Hour Sleep|
10957805|NCT00843843|EG000|Reported Event|9 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
10957806|NCT00843843|EG001|Reported Event|3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
10957807|NCT00843856|BG000|Baseline|Tacrolimus|"Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L~tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml"
10957808|NCT00843856|BG001|Baseline|Tacrolimus and Mycophenolate Mofetil|"tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L~tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L"
10957809|NCT00843856|BG002|Baseline|Total|Total of all reporting groups
10957810|NCT00843856|FG000|Participant Flow|Tacrolimus|"Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L~tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml"
10957811|NCT00843856|FG001|Participant Flow|Tacrolimus and Mycophenolate Mofetil|"tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L~tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L"
10957812|NCT00843856|OG000|Outcome|Tacrolimus|"Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L~tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml"
10957813|NCT00843856|OG001|Outcome|Tacrolimus and Mycophenolate Mofetil|"tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L~tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L"
10957814|NCT00843856|EG000|Reported Event|Tacrolimus|"Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L~tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml"
10957815|NCT00843856|EG001|Reported Event|Tacrolimus and Mycophenolate Mofetil|"tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L~tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L"
10957816|NCT00844051|BG000|Baseline|No Intervention|No school-based influenza vaccination program
10957817|NCT00844051|BG001|Baseline|Intervention|"School-based Influenza Vaccination Program~School-based influenza vaccination program: School-based influenza vaccination program"
10957818|NCT00844051|BG002|Baseline|Total|Total of all reporting groups
10957819|NCT00844051|FG000|Participant Flow|No Intervention|No school-based influenza vaccination program
10957820|NCT00844051|FG001|Participant Flow|Intervention|School-based Influenza Vaccination Program
10957821|NCT00844051|OG000|Outcome|No Intervention|No school-based influenza vaccination program
10957822|NCT00844051|OG001|Outcome|Intervention|School-based Influenza Vaccination Program
10957823|NCT00844051|EG000|Reported Event|No Intervention|No school-based influenza vaccination program
10957824|NCT00844051|EG001|Reported Event|Intervention|School-based Influenza Vaccination Program
10957825|NCT00844090|BG000|Baseline|Methylphenidate|"methylphenidate~methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
10957826|NCT00844090|BG001|Baseline|Placebo|"placebo~methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
10957827|NCT00844090|BG002|Baseline|Total|Total of all reporting groups
10957828|NCT00844090|FG000|Participant Flow|Methylphenidate|"methylphenidate~methylphenidate 10mg twice daily P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
10957829|NCT00844090|FG001|Participant Flow|Placebo|"placebo~placebo only to treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
10957830|NCT00844090|OG000|Outcome|Methylphenidate|"methylphenidate~methylphenidate 10mg BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
10957831|NCT00844090|OG001|Outcome|Placebo|"placebo~Placebo tabs BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
10957832|NCT00844090|EG000|Reported Event|Methyphenidate|"methylphenidate~methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
10957833|NCT00844090|EG001|Reported Event|Placebo|"placebo~Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
10957834|NCT00844194|BG000|Baseline|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
10957835|NCT00844194|BG001|Baseline|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
10957836|NCT00844194|BG002|Baseline|Total|Total of all reporting groups
10957837|NCT00844194|FG000|Participant Flow|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
10957838|NCT00844194|FG001|Participant Flow|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
10957839|NCT00844194|OG000|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
10957840|NCT00844194|OG001|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
10957841|NCT00844194|OG000|Outcome|MDD- Responder|MDD-, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
10957842|NCT00844194|OG001|Outcome|MDD+ Responder|MDD+, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
10957843|NCT00844194|OG002|Outcome|MDD- Non-Responder|MDD-, not treatment responder. 60mg, after week 5 120mg DLX
10957844|NCT00844194|OG003|Outcome|MDD+ Non-Responder|MDD+, not treatment responder. 60mg, after week 5 120mg DLX
10957845|NCT00844194|EG000|Reported Event|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
10957846|NCT00844194|EG001|Reported Event|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
10957847|NCT00844298|BG000|Baseline|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
11178996|NCT02053259|FG002|Participant Flow|Static Physical Activity Goals With Immediate Reinforcement|Static Physical Activity Goals with Immediate Reinforcement
11178997|NCT02053259|FG003|Participant Flow|Static Physical Activity Goals With Delayed Reinforcement|Static Physical Activity Goals with Delayed Reinforcement
11178998|NCT02053259|OG000|Outcome|Adaptive Goals|Adaptive goals
11178999|NCT02053259|OG001|Outcome|Static Goals|Static goals
11179000|NCT02053259|OG002|Outcome|Immediate Reinforcement|Immediate reinforcement
11179001|NCT02053259|OG003|Outcome|Delayed Non-contingent Reinforcement|Delayed non-contingent reinforcement
11179002|NCT02053259|EG000|Reported Event|Arm 1|"Adaptive Goals, Reinforcement~Adaptive Goals~Reinforcement"
11179003|NCT02053259|EG001|Reported Event|Arm 2|"Adaptive Goals, No Reinforcement~Adaptive Goals"
11179004|NCT02053259|EG002|Reported Event|Arm 3|"Static Goals, Reinforcement~Reinforcement~Static Goals"
11179005|NCT02053259|EG003|Reported Event|Arm 4|"Static Goals, No reinforcement~Static Goals"
11179006|NCT02053376|BG000|Baseline|Regorafenib|"Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle~regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle."
11179007|NCT02053376|FG000|Participant Flow|Regorafenib|"Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle~regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle."
11179008|NCT02053376|OG000|Outcome|Regorafenib|"Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle~regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle."
11179009|NCT02053376|EG000|Reported Event|Regorafenib|"Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle~regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle."
11179010|NCT02053493|BG000|Baseline|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
10957848|NCT00844298|FG000|Participant Flow|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
10957849|NCT00844298|OG000|Outcome|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
10957850|NCT00844298|EG000|Reported Event|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
10957851|NCT00844376|BG000|Baseline|All Participants|
10957852|NCT00844376|FG000|Participant Flow|Test Drug First (Atorvastatin EP Suspension)|80-milligram (mg) Extemporaneous preparation (EP) suspension atorvastatin prototype formulation as a single dose in the first intervention period and commercial (reference) 80 mg atorvastatin tablet (Lipitor®) as a single dose in the second intervention period. Period 2 began immediately after period 1.
10957853|NCT00844376|FG001|Participant Flow|Reference Drug First (Atorvastatin Tablet)|80-mg Commercial atorvastatin tablet (Lipitor®) as a single dose in the first intervention period and 80-mg EP suspension atorvastatin prototype formulation as a single dose in the second intervention period. Period 2 began immediately after period 1.
10957854|NCT00844376|OG000|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
10957855|NCT00844376|OG001|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
10957856|NCT00844376|EG000|Reported Event|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
10957857|NCT00844376|EG001|Reported Event|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
10957858|NCT00844415|BG000|Baseline|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
10957859|NCT00844415|FG000|Participant Flow|All Patients (Pat.)|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
10957860|NCT00844415|OG000|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
10957861|NCT00844415|OG000|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
10957862|NCT00844415|EG000|Reported Event|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
10957863|NCT00844428|BG000|Baseline|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957864|NCT00844428|FG000|Participant Flow|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957865|NCT00844428|OG000|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957866|NCT00844428|EG000|Reported Event|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957867|NCT00844519|BG000|Baseline|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
10957868|NCT00844519|BG001|Baseline|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
10957869|NCT00844519|BG002|Baseline|Total|Total of all reporting groups
11179011|NCT02053493|BG001|Baseline|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
11179012|NCT02053493|BG002|Baseline|Total|Total of all reporting groups
10957870|NCT00844519|FG000|Participant Flow|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
10957871|NCT00844519|FG001|Participant Flow|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
10957872|NCT00844519|OG000|Outcome|Maraviroc|maraviroc 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
10957873|NCT00844519|OG001|Outcome|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
10957874|NCT00844519|EG000|Reported Event|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
10957875|NCT00844519|EG001|Reported Event|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
10957876|NCT00844532|BG000|Baseline|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
10957877|NCT00844532|FG000|Participant Flow|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
11179013|NCT02053493|FG000|Participant Flow|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
11179014|NCT02053493|FG001|Participant Flow|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
11179015|NCT02053493|OG000|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
11179016|NCT02053493|OG001|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
10957878|NCT00844532|OG000|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
10957879|NCT00844532|EG000|Reported Event|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
10957880|NCT00844545|BG000|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957881|NCT00844545|FG000|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957882|NCT00844545|OG000|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
10957883|NCT00844545|OG000|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957884|NCT00844545|EG000|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957885|NCT00844558|BG000|Baseline|Gait|The gait participants were randomized and attended 24 biweekly 45-minute sessions directed by a physical therapist, which were composed of guided strategies to optimize knee movements during treadmill walking, using computerized motion analysis with visual biofeedback.
10957886|NCT00844558|BG001|Baseline|Control|The control participants received their usual care for symptomatic knee osteoarthritis (OA) through their usual healthcare providers and were not asked to make changes to their lifestyle.Usual care for these subjects may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery, and/or physical therapy.
10957887|NCT00844558|BG002|Baseline|Total|Total of all reporting groups
10957888|NCT00844558|FG000|Participant Flow|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
10957889|NCT00844558|FG001|Participant Flow|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
10957890|NCT00844558|OG000|Outcome|Gait|No adverse events
10957891|NCT00844558|OG001|Outcome|Control Group|No adverse events
10957892|NCT00844558|OG000|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
10957893|NCT00844558|OG001|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
10957894|NCT00844558|OG001|Outcome|Control|No adverse events
10957895|NCT00844558|OG000|Outcome|Gait Training|"Gait Training Intervention Group Participants~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
10957896|NCT00844558|OG001|Outcome|Control|"Gait Training Control Group Participants~Control: There is no intervention associated with this arm of the study"
10957897|NCT00844558|EG000|Reported Event|Gait|Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
10957898|NCT00844558|EG001|Reported Event|Control|Usual care for symptomatic knee OA through their usual healthcare providers and were not asked to make changes in their lifestyle. Usual care may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery and/or physical therapy.
10957899|NCT00844597|BG000|Baseline|Cohort 1 - 0.5mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957900|NCT00844597|BG001|Baseline|Cohort 2 - 1.0mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957901|NCT00844597|BG002|Baseline|Cohort 3 - 2.0mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
11341773|NCT03687970|OG000|Outcome|Group A: Painful Neuropathy Group|-patients after chemotherapy with painful CIPN who completed Aδ:C fiber detection threshold ratio testing by DLss.
11341774|NCT03687970|OG001|Outcome|Group B: Control Group|-patients after chemotherapy who did not report current (or other long-term) painful CIPN and completed Aδ:C fiber detection threshold ratio testing by DLss.
10957902|NCT00844597|BG003|Baseline|Cohort 4 - 4.0mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957903|NCT00844597|BG004|Baseline|Cohort 5 - 10.0mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957904|NCT00844597|BG005|Baseline|Cohort 6 - 20.0mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957905|NCT00844597|BG006|Baseline|Total|Total of all reporting groups
10957906|NCT00844597|FG000|Participant Flow|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957907|NCT00844597|FG001|Participant Flow|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957908|NCT00844597|FG002|Participant Flow|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group will receive a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957909|NCT00844597|FG003|Participant Flow|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group will receive a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957910|NCT00844597|FG004|Participant Flow|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group will receive a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957911|NCT00844597|FG005|Participant Flow|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group will receive a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
10957912|NCT00844597|OG000|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
10957913|NCT00844597|OG000|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period~AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
10957914|NCT00844597|OG000|Outcome|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
11179017|NCT02053493|EG000|Reported Event|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
11179018|NCT02053493|EG001|Reported Event|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
10957915|NCT00844597|OG001|Outcome|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957916|NCT00844597|OG002|Outcome|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957917|NCT00844597|OG003|Outcome|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957918|NCT00844597|OG004|Outcome|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957919|NCT00844597|OG005|Outcome|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957920|NCT00844597|EG000|Reported Event|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957921|NCT00844597|EG001|Reported Event|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957922|NCT00844597|EG002|Reported Event|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957923|NCT00844597|EG003|Reported Event|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957924|NCT00844597|EG004|Reported Event|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
10957925|NCT00844597|EG005|Reported Event|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
11179019|NCT02053610|BG000|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
11179020|NCT02053610|BG001|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
11179021|NCT02053610|BG002|Baseline|Total|Total of all reporting groups
11179022|NCT02053610|FG000|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
11179023|NCT02053610|FG001|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
11179024|NCT02053610|OG000|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
11179025|NCT02053610|OG001|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
11179026|NCT02053610|EG000|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
11179027|NCT02053610|EG001|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
11179028|NCT02053753|BG000|Baseline|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
10957926|NCT00844649|BG000|Baseline|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|"ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.~Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest"
11179029|NCT02053753|BG001|Baseline|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
11179030|NCT02053753|BG002|Baseline|Total|Total of all reporting groups
11179031|NCT02053753|FG000|Participant Flow|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
11179032|NCT02053753|FG001|Participant Flow|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
11179033|NCT02053753|OG000|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
11179034|NCT02053753|OG001|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
11179035|NCT02053753|EG000|Reported Event|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
11179036|NCT02053753|EG001|Reported Event|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
11179037|NCT02054130|BG000|Baseline|Placebo|Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
11179038|NCT02054130|BG001|Baseline|MEDI9929 70 mg|Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179039|NCT02054130|BG002|Baseline|MEDI9929 210 mg|Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179040|NCT02054130|BG003|Baseline|MEDI9929 280 mg|Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
11179041|NCT02054130|BG004|Baseline|Total|Total of all reporting groups
11179042|NCT02054130|FG000|Participant Flow|Placebo|Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
11179043|NCT02054130|FG001|Participant Flow|MEDI9929 70 mg|Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179044|NCT02054130|FG002|Participant Flow|MEDI9929 210 mg|Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179045|NCT02054130|FG003|Participant Flow|MEDI9929 280 mg|Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
11179046|NCT02054130|OG000|Outcome|Placebo|Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
11179047|NCT02054130|OG001|Outcome|MEDI9929 70 mg|Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179048|NCT02054130|OG002|Outcome|MEDI9929 210 mg|Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179049|NCT02054130|OG003|Outcome|MEDI9929 280 mg|Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
11341775|NCT03687970|OG000|Outcome|Group A: Painful Neuropathy Group|-patients after chemotherapy with painful CIPN who completed NPSI questionnaire were included in the analysis.
10957927|NCT00844649|BG001|Baseline|Gemcitabine|"Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).~Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)."
10957928|NCT00844649|BG002|Baseline|Total|Total of all reporting groups
10957929|NCT00844649|FG000|Participant Flow|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
10957930|NCT00844649|FG001|Participant Flow|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
10957931|NCT00844649|OG000|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
10957932|NCT00844649|OG001|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
10957933|NCT00844649|OG000|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
10957934|NCT00844649|OG001|Outcome|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
10957935|NCT00844649|EG000|Reported Event|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
10957936|NCT00844649|EG001|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
10957937|NCT00844714|BG000|Baseline|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
10957938|NCT00844714|FG000|Participant Flow|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
10957939|NCT00844714|OG000|Outcome|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
10957940|NCT00844714|EG000|Reported Event|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
10957941|NCT00844753|BG000|Baseline|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
10957942|NCT00844753|BG001|Baseline|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
10957943|NCT00844753|BG002|Baseline|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
10957944|NCT00844753|BG003|Baseline|Placebo Without Parent Management Training|Sugar pill administered twice daily.
10957945|NCT00844753|BG004|Baseline|Total|Total of all reporting groups
10957946|NCT00844753|FG000|Participant Flow|Atomoxetine (ATX) + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to adverse events. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training (PT)-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
11179050|NCT02054130|OG000|Outcome|MEDI9929 70 mg|Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179051|NCT02054130|OG001|Outcome|MEDI9929 210 mg|Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
10957947|NCT00844753|FG001|Participant Flow|Atomoxetine (ATX) Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
10957948|NCT00844753|FG002|Participant Flow|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
10957949|NCT00844753|FG003|Participant Flow|Placebo Without Parent Management Training|Sugar pill administered twice daily.
10957950|NCT00844753|OG000|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
10957951|NCT00844753|OG001|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
10957952|NCT00844753|OG002|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
10957953|NCT00844753|OG003|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
10957954|NCT00844753|EG000|Reported Event|Atomoxetine|Data includes both the ATX alone arm and the ATX+ parent therapy arm
10957955|NCT00844753|EG001|Reported Event|Placebo|Data includes the placebo alone arm and the placebo+parent therapy arm
10957956|NCT00844805|BG000|Baseline|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
10957957|NCT00844805|BG001|Baseline|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
10957958|NCT00844805|BG002|Baseline|Total|Total of all reporting groups
10957959|NCT00844805|FG000|Participant Flow|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
10957960|NCT00844805|FG001|Participant Flow|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
10957961|NCT00844805|FG002|Participant Flow|Naproxen|For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
10957962|NCT00844805|FG003|Participant Flow|No Treatment|For participants who achieved partial remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
10957963|NCT00844805|OG000|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
10957964|NCT00844805|OG001|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
10957965|NCT00844805|OG000|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
10957966|NCT00844805|OG001|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
10957967|NCT00844805|OG000|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
10957968|NCT00844805|EG000|Reported Event|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
11179052|NCT02054130|OG002|Outcome|MEDI9929 280 mg|Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
10957969|NCT00844805|EG001|Reported Event|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
10957970|NCT00844805|EG002|Reported Event|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
10957971|NCT00844805|EG003|Reported Event|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
10957972|NCT00844831|BG000|Baseline|Lubiprostone Open Label|
10957973|NCT00844831|FG000|Participant Flow|Lubiprostone Open Label|
10957974|NCT00844831|OG000|Outcome|Before Open Label Lubiprostone|Before 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily.
10957975|NCT00844831|OG001|Outcome|After Open Label Treatment|After 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
10957976|NCT00844831|OG000|Outcome|Treatment With Lubiprostone|Lubiprostone: 24 mcg bid for 28 days
10957977|NCT00844831|OG000|Outcome|Before Open Label Lubiprostone|Bacteria is measured before Lubiprostone: 24 mcg bid for 28 days
10957978|NCT00844831|OG001|Outcome|After Open Label Treatment|Subjects receive lubiprostone and bacteria is measured after Lubiprostone: 24 mcg bid for 28 days
10957979|NCT00844831|EG000|Reported Event|Lubiprostone Open Label|4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
10957980|NCT00844844|BG000|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957981|NCT00844844|FG000|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957982|NCT00844844|OG000|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957983|NCT00844844|EG000|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
10957984|NCT00844857|BG000|Baseline|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
10957985|NCT00844857|BG001|Baseline|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
10957986|NCT00844857|BG002|Baseline|Total|Total of all reporting groups
10957987|NCT00844857|FG000|Participant Flow|Olanzapine/Fluoxetine Combination|Olanzapine/fluoxetine Combination (OFC) 3 milligrams (mg) olanzapine and 25 mg fluoxetine (OFC 3/25) administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
10957988|NCT00844857|FG001|Participant Flow|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
10957989|NCT00844857|OG000|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
10957990|NCT00844857|OG001|Outcome|Placebo|Matched placebo capsule administered orally, once daily for 8 weeks.
10957991|NCT00844857|OG001|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
10957992|NCT00844857|OG000|Outcome|Olanzapine Plus Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
10957993|NCT00844857|OG000|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
10957994|NCT00844857|EG000|Reported Event|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
10957995|NCT00844857|EG001|Reported Event|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
10963795|NCT00874276|FG000|Participant Flow|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
10963796|NCT00874276|FG001|Participant Flow|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
10963797|NCT00874276|OG000|Outcome|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
10963798|NCT00874276|OG001|Outcome|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
10963799|NCT00874276|OG000|Outcome|No EGT Allele|No EGT allele
10963800|NCT00874276|OG001|Outcome|At Least One EGT Allele|At least one EGT allele
10963801|NCT00874276|EG000|Reported Event|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
10963802|NCT00874276|EG001|Reported Event|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
10963803|NCT00874432|BG000|Baseline|Chronic Kidney Disease-ACE-I|"ace inhibitor~lisinopril: 1 x 40 mg per day"
10963804|NCT00874432|BG001|Baseline|Chronic Kidney Disease|angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
11179053|NCT02054130|EG000|Reported Event|Placebo|Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
10963805|NCT00874432|BG002|Baseline|Age Matched Control-ACE-I|"ace-inhibitor~lisinopril: 1 x 40 mg per day"
10963806|NCT00874432|BG003|Baseline|Age Matched Control|"Placebo~angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day"
10963807|NCT00874432|BG004|Baseline|Total|Total of all reporting groups
10963808|NCT00874432|FG000|Participant Flow|Chronic Kidney Disease-ACE-I|"ace inhibitor~lisinopril: 1 x 40 mg per day"
10963809|NCT00874432|FG001|Participant Flow|Chronic Kidney Disease|angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
10963810|NCT00874432|FG002|Participant Flow|Age Matched Control-ACE-I|"ace-inhibitor~lisinopril: 1 x 40 mg per day"
10963811|NCT00874432|FG003|Participant Flow|Age Matched Control|"Placebo~angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day"
10963812|NCT00874432|OG000|Outcome|Chronic Kidney Disease|Participants over age 60 with Chronic Kidney Disease (CKD)
10963813|NCT00874432|OG001|Outcome|Age Matched Control|Healthy age-matched control over age 60
10963814|NCT00874432|OG000|Outcome|Chronic Kidney Disease-ACE-I|"ace inhibitor~lisinopril: 1 x 40 mg per day"
10963815|NCT00874432|OG001|Outcome|Chronic Kidney Disease|angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
10963816|NCT00874432|OG002|Outcome|Age Matched Control-ACE-I|"ace-inhibitor~lisinopril: 1 x 40 mg per day"
10963817|NCT00874432|OG003|Outcome|Age Matched Control|"Placebo~angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day"
10963818|NCT00874432|EG000|Reported Event|Chronic Kidney Disease-ACE-I|"ace inhibitor~lisinopril: 1 x 40 mg per day"
11179054|NCT02054130|EG001|Reported Event|MEDI9929 70 mg|Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179055|NCT02054130|EG002|Reported Event|MEDI9929 210 mg|Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
11179056|NCT02054130|EG003|Reported Event|MEDI9929 280 mg|Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
10957996|NCT00844883|BG000|Baseline|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
10957997|NCT00844883|FG000|Participant Flow|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
10957998|NCT00844883|OG000|Outcome|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
10957999|NCT00844883|EG000|Reported Event|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
10958000|NCT00844896|BG000|Baseline|DEF-only|29 subjects in this arm of the study.
10958001|NCT00844896|BG001|Baseline|DEF + COPE|28 subjects in this arm of the study.
10958002|NCT00844896|BG002|Baseline|Total|Total of all reporting groups
10958003|NCT00844896|FG000|Participant Flow|DEF-only|Distress Emotional Support and Family Assessment Treatment
10958004|NCT00844896|FG001|Participant Flow|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
10958005|NCT00844896|OG000|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
10958006|NCT00844896|OG001|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
10958007|NCT00844896|OG001|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment.
10958008|NCT00844896|EG000|Reported Event|DEF-only|29 subjects in this arm of the study.
10958009|NCT00844896|EG001|Reported Event|DEF + COPE|28 subjects in this arm of the study.
10958010|NCT00845000|BG000|Baseline|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958011|NCT00845000|BG001|Baseline|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958012|NCT00845000|BG002|Baseline|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958013|NCT00845000|BG003|Baseline|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958014|NCT00845000|BG004|Baseline|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958015|NCT00845000|BG005|Baseline|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958016|NCT00845000|BG006|Baseline|Total|Total of all reporting groups
10958017|NCT00845000|FG000|Participant Flow|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958018|NCT00845000|FG001|Participant Flow|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958019|NCT00845000|FG002|Participant Flow|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958020|NCT00845000|FG003|Participant Flow|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958021|NCT00845000|FG004|Participant Flow|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958022|NCT00845000|FG005|Participant Flow|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
10958023|NCT00845000|OG000|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
10958024|NCT00845000|OG001|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
10958025|NCT00845000|OG002|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
10958026|NCT00845000|EG000|Reported Event|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
10958027|NCT00845000|EG001|Reported Event|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
10958028|NCT00845000|EG002|Reported Event|Placebo|Participants who received single oral dose of placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
10958029|NCT00845039|BG000|Baseline|Cetuximab + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
10958030|NCT00845039|BG001|Baseline|Cetuximab + IMC-A12 + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
10958031|NCT00845039|BG002|Baseline|Total|Total of all reporting groups
10958032|NCT00845039|FG000|Participant Flow|Cetuximab + Irinotecan|500 milligrams per square meter (mg/m²) of Cetuximab administered by intravenous (IV) infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
10958033|NCT00845039|FG001|Participant Flow|Cetuximab + IMC-A12 + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 10 milligrams per kilogram (mg/kg) of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
10958034|NCT00845039|OG000|Outcome|Cetuximab + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
10958035|NCT00845039|OG001|Outcome|Cetuximab + IMC-A12 + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day until disease progression or participant intolerance.
10958036|NCT00845039|OG001|Outcome|Cetuximab + IMC-A12 + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
10958037|NCT00845039|OG000|Outcome|Cetuximab + IMC-A12 + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
10958038|NCT00845039|EG000|Reported Event|Cetuximab + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
10958039|NCT00845039|EG001|Reported Event|Cetuximab + IMC-A12 + Irinotecan|500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day until disease progression or participant intolerance.
10958040|NCT00845065|BG000|Baseline|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
10958041|NCT00845065|BG001|Baseline|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
10958042|NCT00845065|BG002|Baseline|Total|Total of all reporting groups
10958043|NCT00845065|FG000|Participant Flow|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
10958044|NCT00845065|FG001|Participant Flow|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
10958045|NCT00845065|OG000|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
10958046|NCT00845065|OG001|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
10958047|NCT00845065|EG000|Reported Event|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
10958048|NCT00845065|EG001|Reported Event|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
10958049|NCT00845130|BG000|Baseline|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
10958050|NCT00845130|BG001|Baseline|Health Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
10958051|NCT00845130|BG002|Baseline|Total|Total of all reporting groups
10958052|NCT00845130|FG000|Participant Flow|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
10958053|NCT00845130|FG001|Participant Flow|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
10958054|NCT00845130|OG000|Outcome|Diabetic Type II Subjects|Vitamin C level in the living brain
10958055|NCT00845130|OG001|Outcome|Healthy Subjects|Vitamin C levels in the living brain.
10958056|NCT00845130|OG000|Outcome|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
10958057|NCT00845130|OG001|Outcome|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
10958058|NCT00845130|EG000|Reported Event|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
10958059|NCT00845130|EG001|Reported Event|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
10958060|NCT00845182|BG000|Baseline|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
10958061|NCT00845182|BG001|Baseline|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
10958062|NCT00845182|BG002|Baseline|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
10958063|NCT00845182|BG003|Baseline|Total|Total of all reporting groups
10958064|NCT00845182|FG000|Participant Flow|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
10958065|NCT00845182|FG001|Participant Flow|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
10958066|NCT00845182|FG002|Participant Flow|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
10958067|NCT00845182|OG000|Outcome|PIOGLITAZONE|PIO therapy led to a weigh gain of 5.5 kg
10958068|NCT00845182|OG001|Outcome|EXENATIDE|PIO therapy led to a weigh loss of 2.4 kg
10958069|NCT00845182|OG002|Outcome|PIOGLITAZONE and EXNATIDE|Combinatiton of PIoglitazone and Exenatide led to weight gain of 2.7 kg
10958070|NCT00845182|OG000|Outcome|Pioglitazone|"Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm~Pioglitazone: Pioglitazone 15 mg/day for 1 month and then 45 mg/day for 5 months"
10958071|NCT00845182|OG001|Outcome|Exenatide|"Exenatide: 15 subjects will be randomized to receive Exenatide~Exenatide: Exenatide 5mcg twice daily for 1 month, then 10mcg twice daily for 5 months"
10958072|NCT00845182|OG002|Outcome|Drug Pioglitazone and Drug Exentatide|"Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide~Pioglitazone and Exenatide: Pioglitazone 30mg daily for 1 month and then 45mg daily for 5 months and Exenatide 5mcg twice daily for one month then 10mcg twice daily for 5 months"
10958073|NCT00845182|OG000|Outcome|Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatid|"Effect pioglitazone, exenatide, and pioglitazone plus exenatide on~Insulin sensitivity~Inflammatory cytokines~glucagon and free fatty acids~plasma lipids measured over a 6 month period"
10958074|NCT00845182|EG000|Reported Event|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
10958075|NCT00845182|EG001|Reported Event|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
10958076|NCT00845182|EG002|Reported Event|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
10958077|NCT00845195|BG000|Baseline|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
10958078|NCT00845195|BG001|Baseline|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
10958079|NCT00845195|BG002|Baseline|Total|Total of all reporting groups
10958080|NCT00845195|FG000|Participant Flow|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
10958081|NCT00845195|FG001|Participant Flow|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
10958082|NCT00845195|OG000|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
10958083|NCT00845195|OG001|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
10958084|NCT00845195|EG000|Reported Event|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
10958085|NCT00845195|EG001|Reported Event|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
10958086|NCT00845429|BG000|Baseline|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
10958087|NCT00845429|BG001|Baseline|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
10958088|NCT00845429|BG002|Baseline|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
10958089|NCT00845429|BG003|Baseline|Total|Total of all reporting groups
10958090|NCT00845429|FG000|Participant Flow|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
10958091|NCT00845429|FG001|Participant Flow|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
10958092|NCT00845429|FG002|Participant Flow|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
10958093|NCT00845429|OG000|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
11179057|NCT02054156|BG000|Baseline|Azithromycin|"azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months~azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months~Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months"
10958094|NCT00845429|OG001|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
10958095|NCT00845429|OG002|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
10958096|NCT00845429|EG000|Reported Event|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
10958097|NCT00845429|EG001|Reported Event|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
10958098|NCT00845429|EG002|Reported Event|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
10958099|NCT00845481|BG000|Baseline|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
10958100|NCT00845481|FG000|Participant Flow|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
10958101|NCT00845481|OG000|Outcome|Patients Treated With Daivobet® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
10958102|NCT00845481|OG000|Outcome|Patients Treated With Betnovat® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Betnovat® ointment
11341776|NCT03687970|OG001|Outcome|Group B: Control Group|-patients after chemotherapy who did not report current (or other long-term) painful CIPN and completed NPSI questionnaire were included in the analysis.
10958103|NCT00845481|OG000|Outcome|Patients Treated With Elocon Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Elocon ointment
10958104|NCT00845481|OG000|Outcome|Patients Treated With Daivobet® Ointment Vehicle|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® Ointment vehicle
10958105|NCT00845481|OG000|Outcome|Patients Treated With Dermovat Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Dermovat ointment
10958106|NCT00845481|OG000|Outcome|Patients Treated With Diprosalic Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Diprosalic ointment
10958107|NCT00845481|EG000|Reported Event|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
10958108|NCT00845507|BG000|Baseline|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
10958109|NCT00845507|BG001|Baseline|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
10958110|NCT00845507|BG002|Baseline|Total|Total of all reporting groups
10958111|NCT00845507|FG000|Participant Flow|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
11341777|NCT03687970|EG000|Reported Event|Group A: Painful CIPN Group|All patients who were enrolled in the Case group and completed any testing
10958112|NCT00845507|FG001|Participant Flow|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
10958113|NCT00845507|OG000|Outcome|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
10958114|NCT00845507|OG001|Outcome|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
10958115|NCT00845507|EG000|Reported Event|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
10958116|NCT00845507|EG001|Reported Event|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
10958117|NCT00845520|BG000|Baseline|Lens Implant Power +1.00 D Target|The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 diopter
10958118|NCT00845520|BG001|Baseline|Lens Implant Power 0.00 D Target|The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 diopter
10958119|NCT00845520|BG002|Baseline|Lens Implant Power -1.00 D Target|The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 11.00 diopter
10958120|NCT00845520|BG003|Baseline|Total|Total of all reporting groups
10958121|NCT00845520|FG000|Participant Flow|Lens Implant Power +1.00 D Target|Lens implant power +1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative +1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
10958122|NCT00845520|FG001|Participant Flow|Lens Implant Power -1.00 D Target|Lens implant power -1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative -1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
10958123|NCT00845520|FG002|Participant Flow|Lens Implant Power 0.00 D Target|Lens implant power 0.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative 0.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
10958124|NCT00845520|OG000|Outcome|Lens Implant Power -1.00 D Target|Eyes randomized to a target lens implant power of -1.00 D
10958125|NCT00845520|OG001|Outcome|Lens Implant Power +1.00 D Target|Eyes randomized to a target lens implant power of +1.00 D
10958126|NCT00845520|OG002|Outcome|Lens Implant Power 0.00 D Target|Eyes randomized to a target lens implant power of 0.00 D
10958127|NCT00845520|OG000|Outcome|Lens Implant Power -1.00 D Target|Eyes randomized to a target of -1.00 D
10958128|NCT00845520|OG001|Outcome|Lens Implant Power of +1.00 D|Eyes randomized to a target of +1.00 D
11341778|NCT03687970|EG001|Reported Event|Group B: Control Group|All patients who were enrolled in the Control group and completed any testing
10958129|NCT00845520|OG002|Outcome|Lens Implant Power of 0.0 D Target|Eyes randomized to a target of 0.0 D
10958130|NCT00845520|OG000|Outcome|Lens Implant Power With -1.00 D Target|Eyes randomized to a postoperative target MRSE of -1.00 D
10958131|NCT00845520|OG001|Outcome|Lens Implant Power With 0.00 D Target|Eyes randomized to a postoperative target MRSE of 0.00 D
10958132|NCT00845520|OG002|Outcome|Lens Implant Power With +1.00 D Target|Eyes randomized to a postoperative target MRSE of +1.00 D
10958133|NCT00845520|EG000|Reported Event|Lens Implant Power of +1.00 D Target|Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 D
10958134|NCT00845520|EG001|Reported Event|Lens Implant Power of -1.00 D Target|Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of -1.00 D
10958135|NCT00845520|EG002|Reported Event|Lens Implant Power of 0.00 D|Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 D
10958136|NCT00845650|BG000|Baseline|AIGIV 3.5 mg/kg (Cohort A)|AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
10958137|NCT00845650|BG001|Baseline|Gamunex 90 mg/kg (Cohort A)|Gamunex 90 mg/kg total IgG as a single intravenous infusion.
10958138|NCT00845650|BG002|Baseline|AIGIV 7.0 mg/kg (Cohort B)|AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958139|NCT00845650|BG003|Baseline|Gamunex 180 mg/kg (Cohort B)|Gamunex 180 mg/kg total IgG as a single intravenous infusion.
10958140|NCT00845650|BG004|Baseline|AIGIV 14.0 mg/kg (Cohort C)|AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958141|NCT00845650|BG005|Baseline|Gamunex 360 mg/kg (Cohort C)|Gamunex 360 mg/kg total IgG as a single intravenous infusion.
10958142|NCT00845650|BG006|Baseline|Total|Total of all reporting groups
10958143|NCT00845650|FG000|Participant Flow|AIGIV 3.5 mg/kg (Cohort A)|AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
10958144|NCT00845650|FG001|Participant Flow|Gamunex 90 mg/kg (Cohort A)|Gamunex 90 mg/kg total IgG as a single intravenous infusion.
10958145|NCT00845650|FG002|Participant Flow|AIGIV 7.0 mg/kg (Cohort B)|AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958146|NCT00845650|FG003|Participant Flow|Gamunex 180 mg/kg (Cohort B)|Gamunex 180 mg/kg total IgG as a single intravenous infusion.
10958147|NCT00845650|FG004|Participant Flow|AIGIV 14.0 mg/kg (Cohort C)|AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958148|NCT00845650|FG005|Participant Flow|Gamunex 360 mg/kg (Cohort C)|Gamunex 360 mg/kg total IgG as a single intravenous infusion.
10958149|NCT00845650|OG000|Outcome|AIGIV 3.5 mg/kg (Cohort A)|AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
10958150|NCT00845650|OG001|Outcome|Gamunex 90 mg/kg (Cohort A)|Gamunex 90 mg/kg total IgG as a single intravenous infusion.
10958151|NCT00845650|OG002|Outcome|AIGIV 7.0 mg/kg (Cohort B)|AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958152|NCT00845650|OG003|Outcome|Gamunex 180 mg/kg (Cohort B)|Gamunex 180 mg/kg total IgG as a single intravenous infusion.
10958153|NCT00845650|OG004|Outcome|AIGIV 14.0 mg/kg (Cohort C)|AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958154|NCT00845650|OG005|Outcome|Gamunex 360 mg/kg (Cohort C)|Gamunex 360 mg/kg total IgG as a single intravenous infusion.
10958155|NCT00845650|OG001|Outcome|AIGIV 7.0 mg/kg (Cohort B)|AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958156|NCT00845650|OG002|Outcome|AIGIV 14.0 mg/kg (Cohort C)|AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958157|NCT00845650|EG000|Reported Event|AIGIV 3.5 mg/kg (Cohort A)|AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
10958158|NCT00845650|EG001|Reported Event|Gamunex 90 mg/kg (Cohort A)|Gamunex 90 mg/kg total IgG as a single intravenous infusion.
10958159|NCT00845650|EG002|Reported Event|AIGIV 7.0 mg/kg (Cohort B)|AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958160|NCT00845650|EG003|Reported Event|Gamunex 180 mg/kg (Cohort B)|Gamunex 180 mg/kg total IgG as a single intravenous infusion.
10958161|NCT00845650|EG004|Reported Event|AIGIV 14.0 mg/kg (Cohort C)|AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
10958162|NCT00845650|EG005|Reported Event|Gamunex 360 mg/kg (Cohort C)|Gamunex 360 mg/kg total IgG as a single intravenous infusion.
10958163|NCT00845663|BG000|Baseline|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
10958164|NCT00845663|BG001|Baseline|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
10958165|NCT00845663|BG002|Baseline|Total|Total of all reporting groups
10958166|NCT00845663|FG000|Participant Flow|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
10958167|NCT00845663|FG001|Participant Flow|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
10958168|NCT00845663|OG000|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
10958169|NCT00845663|OG001|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
10958170|NCT00845663|EG000|Reported Event|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
10958171|NCT00845663|EG001|Reported Event|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
10958172|NCT00845676|BG000|Baseline|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
10958173|NCT00845676|FG000|Participant Flow|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
10958174|NCT00845676|OG000|Outcome|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
10958175|NCT00845676|OG000|Outcome|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
10958176|NCT00845676|EG000|Reported Event|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
10958177|NCT00845728|BG000|Baseline|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.~delivered via the manufacturer's proprietary inhalation device (Handihaler®)"
10958178|NCT00845728|BG001|Baseline|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
10958179|NCT00845728|BG002|Baseline|Total|Total of all reporting groups
10958180|NCT00845728|FG000|Participant Flow|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.~delivered via the manufacturer's proprietary inhalation device (Handihaler®)"
10958181|NCT00845728|FG001|Participant Flow|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
10958182|NCT00845728|OG000|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®)
10958183|NCT00845728|OG001|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
10958184|NCT00845728|EG000|Reported Event|IndIndacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®)
10958185|NCT00845728|EG001|Reported Event|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
10958186|NCT00845832|BG000|Baseline|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958187|NCT00845832|BG001|Baseline|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958188|NCT00845832|BG002|Baseline|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958189|NCT00845832|BG003|Baseline|Total|Total of all reporting groups
10958190|NCT00845832|FG000|Participant Flow|Placebo + Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received placebo intravenously (iv) on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
11179058|NCT02054156|BG001|Baseline|Placebo|"placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months~placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months~Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months"
10958191|NCT00845832|FG001|Participant Flow|Rituximab (0.5 Grams [g]) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958192|NCT00845832|FG002|Participant Flow|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958193|NCT00845832|OG000|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958194|NCT00845832|OG001|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958195|NCT00845832|OG002|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958196|NCT00845832|EG000|Reported Event|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958197|NCT00845832|EG001|Reported Event|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
11179059|NCT02054156|BG002|Baseline|Total|Total of all reporting groups
10958198|NCT00845832|EG002|Reported Event|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
10958199|NCT00845858|BG000|Baseline|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958200|NCT00845858|BG001|Baseline|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958201|NCT00845858|BG002|Baseline|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
10958202|NCT00845858|BG003|Baseline|Total|Total of all reporting groups
10958203|NCT00845858|FG000|Participant Flow|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958204|NCT00845858|FG001|Participant Flow|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958205|NCT00845858|FG002|Participant Flow|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
11179060|NCT02054156|FG000|Participant Flow|Azithromycin|"azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months~azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months~Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months"
10958206|NCT00845858|OG000|Outcome|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958207|NCT00845858|OG001|Outcome|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958208|NCT00845858|OG002|Outcome|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
10958209|NCT00845858|OG000|Outcome|Female-Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958210|NCT00845858|OG001|Outcome|Female-Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958211|NCT00845858|OG002|Outcome|Female-Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
10958212|NCT00845858|EG000|Reported Event|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958213|NCT00845858|EG001|Reported Event|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
10958214|NCT00845858|EG002|Reported Event|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
10958215|NCT00845871|BG000|Baseline|Deferasirox|Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958216|NCT00845871|FG000|Participant Flow|Deferasirox|Participants were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal for 4 weeks of Run-in period. Where as, Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958217|NCT00845871|OG000|Outcome|Breakfast (Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958218|NCT00845871|OG001|Outcome|Breakfast (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958219|NCT00845871|OG002|Outcome|Dinner (Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958220|NCT00845871|OG003|Outcome|Dinner (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958221|NCT00845871|OG004|Outcome|No Meal (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958222|NCT00845871|OG005|Outcome|No Meal Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958223|NCT00845871|OG000|Outcome|Deferasirox (Run-in Phase)|Participants were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal.
10958224|NCT00845871|OG001|Outcome|Breakfast (Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958225|NCT00845871|OG002|Outcome|Breakfast (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958226|NCT00845871|OG003|Outcome|Dinner (Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958227|NCT00845871|OG004|Outcome|Dinner (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958228|NCT00845871|OG005|Outcome|No Meal (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958229|NCT00845871|OG006|Outcome|No Meal Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958230|NCT00845871|OG000|Outcome|Deferasirox|Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958231|NCT00845871|EG000|Reported Event|Deferasirox (Run-in Phase)|Participants were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal.
10958232|NCT00845871|EG001|Reported Event|Breakfast (Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958233|NCT00845871|EG002|Reported Event|Breakfast (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958234|NCT00845871|EG003|Reported Event|Dinner (Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958235|NCT00845871|EG004|Reported Event|Dinner (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958236|NCT00845871|EG005|Reported Event|No Meal (Deferasirox With Liquid)|Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958237|NCT00845871|EG006|Reported Event|No Meal (Deferasirox With Soft Food)|Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving > 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
10958238|NCT00845871|EG007|Reported Event|Deferasirox (Overall)|Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For subjects receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
10958239|NCT00845897|BG000|Baseline|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
10958240|NCT00845897|BG001|Baseline|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
10958241|NCT00845897|BG002|Baseline|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
10958242|NCT00845897|BG003|Baseline|Total|Total of all reporting groups
10958243|NCT00845897|FG000|Participant Flow|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
10958244|NCT00845897|FG001|Participant Flow|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
10958245|NCT00845897|FG002|Participant Flow|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
10958246|NCT00845897|OG000|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
10958247|NCT00845897|OG001|Outcome|Placebo|Saline
10958248|NCT00845897|OG002|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
10958249|NCT00845897|EG000|Reported Event|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
10958250|NCT00845897|EG001|Reported Event|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
10958251|NCT00845897|EG002|Reported Event|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
10958252|NCT00845975|BG000|Baseline|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
10958253|NCT00845975|BG001|Baseline|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
10958254|NCT00845975|BG002|Baseline|Total|Total of all reporting groups
10963819|NCT00874432|EG001|Reported Event|Chronic Kidney Disease|angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
10963820|NCT00874432|EG002|Reported Event|Age Matched Control-ACE-I|"ace-inhibitor~lisinopril: 1 x 40 mg per day"
10958255|NCT00845975|FG000|Participant Flow|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
10958256|NCT00845975|FG001|Participant Flow|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
10958257|NCT00845975|OG000|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
10958258|NCT00845975|OG001|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
10958259|NCT00845975|EG000|Reported Event|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
10958260|NCT00845975|EG001|Reported Event|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
10958261|NCT00846027|BG000|Baseline|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
10958262|NCT00846027|FG000|Participant Flow|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
10958263|NCT00846027|OG000|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
10958264|NCT00846027|EG000|Reported Event|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
10958265|NCT00846040|BG000|Baseline|Obese RF Then RC|Obese adult volunteers (BMI above 30 kg/m2) randomized to receive an 85% reduction of baseline dietary fat for 2 weeks, then a 60% reduction of baseline dietary carbohydrate for 2 weeks
10958266|NCT00846040|BG001|Baseline|Obese RC Then RF|Obese adult volunteers (BMI above 30 kg/m2) randomized to receive a 60% reduction of baseline dietary carbohydrate for 2 weeks, then an 85% reduction of baseline dietary fat for 2 weeks.
10958267|NCT00846040|BG002|Baseline|Lean Control|Lean adult volunteers (BMI below 30kg/m2) placed on a weight-maintenance diet using a standard diet composition of 50% carbohydrate, 35% fat, and 15% protein on an out-patient basis
10958268|NCT00846040|BG003|Baseline|Total|Total of all reporting groups
10958269|NCT00846040|FG000|Participant Flow|Obese RF Then RC|Obese adult volunteers (BMI above 30 kg/m2) randomized to receive an 85% reduction of baseline dietary fat for 2 weeks, then a 60% reduction of baseline dietary carbohydrate for 2 weeks. Each admission starts with a 5 day baseline period before the randomized diet.
10958270|NCT00846040|FG001|Participant Flow|Obese RC Then RF|Obese adult volunteers (BMI above 30 kg/m2) randomized to receive a 60% reduction of baseline dietary carbohydrate for 2 weeks, then an 85% reduction of baseline dietary fat for 2 weeks. Each admission starts with a 5 day baseline period before the randomized diet.
10958271|NCT00846040|FG002|Participant Flow|Lean Control|Lean adult volunteers (BMI below 30kg/m2) placed on a weight-maintenance diet using a standard diet composition of 50% carbohydrate, 35% fat, and 15% protein for 2 days on an out-patient basis followed by an admission to the metabolic unit for 3 days.
10958272|NCT00846040|OG000|Outcome|RC Diet|Reduced carbohydrate diet
10958273|NCT00846040|OG001|Outcome|RF Diet|Reduced fat diet
10958274|NCT00846040|OG000|Outcome|Obese|Obese adult volunteers (BMI above 30 kg/m2)
10958275|NCT00846040|OG001|Outcome|Lean Control|Lean adult volunteers (BMI below 30kg/m2)
10958276|NCT00846040|EG000|Reported Event|Obese Reduced Carbohydrate|Reduced carbohydrate diet (selective reduction of 60% of baseline carbohydrate calories per day)
10958277|NCT00846040|EG001|Reported Event|Obese Reduced Fat|Reduced fat diet (selective reduction of 85% of baseline fat calories per day)
10958278|NCT00846040|EG002|Reported Event|Lean Control|Lean adult volunteers (BMI below 30kg/m2) placed on a weight-maintenance diet using a standard diet composition of 50% carbohydrate, 35% fat, and 15% protein on an out-patient basis
10958279|NCT00846053|BG000|Baseline|Stable Lung Function|Group S (n = 14) will consist of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.
10958280|NCT00846053|BG001|Baseline|Rapidly Declining Lung Function|Group R (n = 14) will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years with greater than 4% per year decline, as defined in our previous study.
10958281|NCT00846053|BG002|Baseline|Total|Total of all reporting groups
10958282|NCT00846053|FG000|Participant Flow|Stable Lung Function|Group S will consist of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.
10958283|NCT00846053|FG001|Participant Flow|Rapidly Decline Lung Function|Group R will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years with greater than 4% per year decline.
10958284|NCT00846053|OG000|Outcome|Stable Lung Function|Group S (n = 10) consisted of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.
10958285|NCT00846053|OG001|Outcome|Rapidly Declining Lung Function|Group R (n = 8) will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years
10958286|NCT00846053|OG000|Outcome|Stable Lung Function|Group S (n = 10) consists of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.
10958287|NCT00846053|OG001|Outcome|Rapidly Declining Lung Function|Group R (n = 8) contains CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years
10958288|NCT00846053|EG000|Reported Event|Stable Lung Function|No adverse events
10958289|NCT00846053|EG001|Reported Event|Rapidly Declining Lung Function|No adverse events
11179061|NCT02054156|FG001|Participant Flow|Placebo|"placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months~placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months~Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months"
10958290|NCT00846066|BG000|Baseline|WBT Only|Control Group Web Based Training only
10958291|NCT00846066|BG001|Baseline|WBT+HOT|Web Based Training plus Hands on Training
10958292|NCT00846066|BG002|Baseline|Total|Total of all reporting groups
10958293|NCT00846066|FG000|Participant Flow|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
10958294|NCT00846066|FG001|Participant Flow|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
10958295|NCT00846066|OG000|Outcome|WBT Only|Control Group Web Based Training only
10958296|NCT00846066|OG001|Outcome|WBT+HOT|Web Based Training plus Hands on Training
10958297|NCT00846066|OG001|Outcome|WBT + HOT|Web Based Training plus Hands on Training
10958298|NCT00846066|EG000|Reported Event|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
10958299|NCT00846066|EG001|Reported Event|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
10958300|NCT00846287|BG000|Baseline|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
10958301|NCT00846287|BG001|Baseline|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
10958302|NCT00846287|BG002|Baseline|Total|Total of all reporting groups
10958303|NCT00846287|FG000|Participant Flow|Active Comparator: Saline|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
10958304|NCT00846287|FG001|Participant Flow|Active Comparator: Drug Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
10958305|NCT00846287|OG000|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
10958306|NCT00846287|OG001|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
10958307|NCT00846287|EG000|Reported Event|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
10958308|NCT00846287|EG001|Reported Event|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
10958309|NCT00846365|BG000|Baseline|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958310|NCT00846365|BG001|Baseline|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958311|NCT00846365|BG002|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958312|NCT00846365|BG003|Baseline|Total|Total of all reporting groups
10958313|NCT00846365|FG000|Participant Flow|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958314|NCT00846365|FG001|Participant Flow|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958315|NCT00846365|FG002|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958316|NCT00846365|OG000|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958317|NCT00846365|OG001|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958318|NCT00846365|OG002|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958319|NCT00846365|EG000|Reported Event|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958320|NCT00846365|EG001|Reported Event|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958321|NCT00846365|EG002|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
10958322|NCT00846391|BG000|Baseline|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
10958323|NCT00846391|BG001|Baseline|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
10958324|NCT00846391|BG002|Baseline|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
10958325|NCT00846391|BG003|Baseline|Total|Total of all reporting groups
10958326|NCT00846391|FG000|Participant Flow|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
10958327|NCT00846391|FG001|Participant Flow|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
10958328|NCT00846391|FG002|Participant Flow|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
10958329|NCT00846391|OG000|Outcome|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
10958330|NCT00846391|OG001|Outcome|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
10958331|NCT00846391|OG002|Outcome|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
10958332|NCT00846391|EG000|Reported Event|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
10958333|NCT00846391|EG001|Reported Event|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
10958334|NCT00846391|EG002|Reported Event|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
10958335|NCT00846482|BG000|Baseline|Resected or Metastatic CRC|"All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin~Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks"
10958336|NCT00846482|FG000|Participant Flow|Resected or Metastatic CRC|"All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin~Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks"
10958337|NCT00846482|OG000|Outcome|All Patients With CRC|"All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin~Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks"
10958338|NCT00846482|OG000|Outcome|Resected or Metastatic CRC|"All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin~Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks"
10958339|NCT00846482|EG000|Reported Event|Resected or Metastatic CRC|"All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin~Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks"
10958340|NCT00846495|BG000|Baseline|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
10958341|NCT00846495|BG001|Baseline|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
10958342|NCT00846495|BG002|Baseline|Total|Total of all reporting groups
10958343|NCT00846495|FG000|Participant Flow|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
10958344|NCT00846495|FG001|Participant Flow|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
11179062|NCT02054156|OG000|Outcome|Azithromycin|"azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months~azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months~Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months"
11179063|NCT02054156|OG001|Outcome|Placebo|"placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months~placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months~Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months"
11179064|NCT02054156|EG000|Reported Event|Azithromycin|"azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months~azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months~Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months"
11179065|NCT02054156|EG001|Reported Event|Placebo|"placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months~placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months~Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months"
11179066|NCT02054325|BG000|Baseline|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
11179067|NCT02054325|BG001|Baseline|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
10958345|NCT00846495|OG000|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
10958346|NCT00846495|OG001|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
10958347|NCT00846495|EG000|Reported Event|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
11179068|NCT02054325|BG002|Baseline|Total|Total of all reporting groups
11179069|NCT02054325|FG000|Participant Flow|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
11179070|NCT02054325|FG001|Participant Flow|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
11179071|NCT02054325|OG000|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
10958348|NCT00846495|EG001|Reported Event|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
10958349|NCT00846521|BG000|Baseline|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).~Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
10963821|NCT00874432|EG003|Reported Event|Age Matched Control|"Placebo~angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day"
10963822|NCT00874497|BG000|Baseline|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
10958350|NCT00846521|FG000|Participant Flow|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).~Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
10958351|NCT00846521|OG000|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
10958352|NCT00846521|EG000|Reported Event|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
10958353|NCT00846547|BG000|Baseline|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
10958354|NCT00846547|FG000|Participant Flow|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
10958355|NCT00846547|OG000|Outcome|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
10958356|NCT00846547|EG000|Reported Event|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
10958357|NCT00846573|BG000|Baseline|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10958358|NCT00846573|BG001|Baseline|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
10958359|NCT00846573|BG002|Baseline|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10958360|NCT00846573|BG003|Baseline|Total|Total of all reporting groups
10958361|NCT00846573|FG000|Participant Flow|COPD|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10958362|NCT00846573|FG001|Participant Flow|Asthma|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
10958363|NCT00846573|FG002|Participant Flow|Cystic Fibrosis|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10958364|NCT00846573|FG003|Participant Flow|Healthy|"This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10958365|NCT00846573|OG000|Outcome|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10958366|NCT00846573|OG001|Outcome|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
10958367|NCT00846573|OG002|Outcome|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10958368|NCT00846573|EG000|Reported Event|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10963823|NCT00874497|BG001|Baseline|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
10958369|NCT00846573|EG001|Reported Event|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
10958370|NCT00846573|EG002|Reported Event|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
10958371|NCT00846586|BG000|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10958372|NCT00846586|BG001|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10958373|NCT00846586|BG002|Baseline|Total|Total of all reporting groups
10958374|NCT00846586|FG000|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10958375|NCT00846586|FG001|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10958376|NCT00846586|OG000|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10958377|NCT00846586|OG001|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10958378|NCT00846586|EG000|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10958379|NCT00846586|EG001|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10958380|NCT00846651|BG000|Baseline|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
10958381|NCT00846651|BG001|Baseline|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
10958382|NCT00846651|BG002|Baseline|Total|Total of all reporting groups
10958383|NCT00846651|FG000|Participant Flow|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
10958384|NCT00846651|FG001|Participant Flow|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
10958385|NCT00846651|OG000|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
10958386|NCT00846651|OG001|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
10958387|NCT00846651|OG000|Outcome|Colloid, Then Phenylephrine Infusion|"colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.~Colloid administration: The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.~phenylephrine infusion: A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."
10958388|NCT00846651|OG001|Outcome|Crystalloid, Then Phenylephrine Infusion|"crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.~Crystalloid administration: The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.~phenylephrine infusion: A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."
10958389|NCT00846651|EG000|Reported Event|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
10958390|NCT00846651|EG001|Reported Event|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
10958391|NCT00846768|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, active-controlled, 4 way crossover trial. 47 patients were assigned randomly to one of 4 treatment sequences in which they received each of the 4 treatments. The duration of each treatment period was 3 weeks with no washout period between treatments.
10958392|NCT00846768|FG000|Participant Flow|Olo 2mcg Bid / Olo 10mcg qd / Olo 5mcg qd / Olo 5mcg Bid|Patients were administered Olodaterol 2 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and Olodaterol 5 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
10958393|NCT00846768|FG001|Participant Flow|Olo 5mcg qd / Olo 2mcg Bid / Olo 5mcg Bid / Olo 10mcg qd|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg bid in the second period, Olodaterol 5 mcg bid in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
10958394|NCT00846768|FG002|Participant Flow|Olo 5mcg Bid / Olo 5mcg qd / Olo 10mcg qd / Olo 2mcg Bid|Patients were administered Olodaterol 5 mcg bid in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 2 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
10958395|NCT00846768|FG003|Participant Flow|Olo 10mcg qd / Olo 5mcg Bid / Olo 2mcg Bid / Olo 5mcg qd|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg bid in the second period, Olodaterol 2 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
10958396|NCT00846768|OG000|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
10958397|NCT00846768|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
10958398|NCT00846768|OG002|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
10958399|NCT00846768|OG003|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
10958400|NCT00846768|EG000|Reported Event|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
10958401|NCT00846768|EG001|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
10958402|NCT00846768|EG002|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
11179072|NCT02054325|OG001|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
10958403|NCT00846768|EG003|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
10958404|NCT00846807|BG000|Baseline|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
10958405|NCT00846807|FG000|Participant Flow|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
10958406|NCT00846807|OG000|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
10958407|NCT00846807|EG000|Reported Event|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
10958408|NCT00846846|BG000|Baseline|Endeavor® Zotarolimus Eluting Coronary Stent System|Endeavor® Zotarolimus Eluting Coronary Stent Implantation in a patient population requiring stent implantation.
10958409|NCT00846846|FG000|Participant Flow|Endeavor® Zotarolimus Eluting Coronary Stent System|"Endeavor® Zotarolimus Eluting Coronary Stent System>~> Endeavor® Zotarolimus Eluting Coronary Stent System: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation"
10958410|NCT00846846|OG000|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
10958411|NCT00846846|EG000|Reported Event|Endeavor|Medtronic Endeavor
10963824|NCT00874497|BG002|Baseline|Total|Total of all reporting groups
10963825|NCT00874497|FG000|Participant Flow|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
10958412|NCT00847015|BG000|Baseline|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
10958413|NCT00847015|FG000|Participant Flow|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
10958414|NCT00847015|OG000|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
10958415|NCT00847015|EG000|Reported Event|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
11179073|NCT02054325|EG000|Reported Event|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
11179074|NCT02054325|EG001|Reported Event|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
11179075|NCT02054338|BG000|Baseline|Vinflunine Plus Gemcitabine|"vinflunine 320 mg/m² D1 plus gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks~Vinflunine~vinflunine plus gemcitabine: 320 mg/m² IV on day 1 plus gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks"
11179076|NCT02054338|BG001|Baseline|Paclitaxel Plus Gemcitabine|"paclitaxel 175 mg/m² D1 followed by Gemcitabine 1250 mg/m² D1 and D8 every 3 weeks~paclitaxel plus gemcitabine: paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1"
10958416|NCT00847132|BG000|Baseline|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
10958417|NCT00847132|BG001|Baseline|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
10958418|NCT00847132|BG002|Baseline|Total|Total of all reporting groups
10958419|NCT00847132|FG000|Participant Flow|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
10958420|NCT00847132|FG001|Participant Flow|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
10958421|NCT00847132|OG000|Outcome|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
10963826|NCT00874497|FG001|Participant Flow|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
11179077|NCT02054338|BG002|Baseline|Total|Total of all reporting groups
11179078|NCT02054338|FG000|Participant Flow|Vinflunine Plus Gemcitabine|"vinflunine 320 mg/m² D1 plus gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks~Vinflunine~vinflunine plus gemcitabine: 320 mg/m² IV on day 1 plus gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks"
11179079|NCT02054338|FG001|Participant Flow|Paclitaxel Plus Gemcitabine|"paclitaxel 175 mg/m² D1 followed by Gemcitabine 1250 mg/m² D1 and D8 every 3 weeks~paclitaxel plus gemcitabine: paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1"
11179080|NCT02054338|OG000|Outcome|Vinflunine Plus Gemcitabine|"vinflunine 320 mg/m² D1 plus gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks~Vinflunine~vinflunine plus gemcitabine: 320 mg/m² IV on day 1 plus gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks"
11179081|NCT02054338|OG001|Outcome|Paclitaxel Plus Gemcitabine|"paclitaxel 175 mg/m² D1 followed by Gemcitabine 1250 mg/m² D1 and D8 every 3 weeks~paclitaxel plus gemcitabine: paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1"
10958422|NCT00847132|OG001|Outcome|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
10958423|NCT00847132|EG000|Reported Event|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
10958424|NCT00847132|EG001|Reported Event|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
11179082|NCT02054338|EG000|Reported Event|Vinflunine Plus Gemcitabine|"vinflunine 320 mg/m² D1 plus gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks~Vinflunine~vinflunine plus gemcitabine: 320 mg/m² IV on day 1 plus gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks"
11179083|NCT02054338|EG001|Reported Event|Paclitaxel Plus Gemcitabine|"paclitaxel 175 mg/m² D1 followed by Gemcitabine 1250 mg/m² D1 and D8 every 3 weeks~paclitaxel plus gemcitabine: paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1"
11179084|NCT02054481|BG000|Baseline|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
10958425|NCT00847145|BG000|Baseline|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
11179085|NCT02054481|BG001|Baseline|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
11179086|NCT02054481|BG002|Baseline|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
11179087|NCT02054481|BG003|Baseline|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
11179088|NCT02054481|BG004|Baseline|Total|Total of all reporting groups
11179089|NCT02054481|FG000|Participant Flow|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
11179090|NCT02054481|FG001|Participant Flow|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
11179091|NCT02054481|FG002|Participant Flow|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
10958426|NCT00847145|BG001|Baseline|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
11179092|NCT02054481|FG003|Participant Flow|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
11179093|NCT02054481|OG000|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
11179094|NCT02054481|OG001|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
10958427|NCT00847145|BG002|Baseline|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
10958428|NCT00847145|BG003|Baseline|12M12B14B (2b)|Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
11179095|NCT02054481|OG002|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
11179096|NCT02054481|OG003|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
11179097|NCT02054481|OG004|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
11179098|NCT02054481|EG000|Reported Event|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
11179099|NCT02054481|EG001|Reported Event|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
11179100|NCT02054481|EG002|Reported Event|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
10958429|NCT00847145|BG004|Baseline|12B12M (3a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
10958430|NCT00847145|BG005|Baseline|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
10958431|NCT00847145|BG006|Baseline|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
10958432|NCT00847145|BG007|Baseline|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
10958433|NCT00847145|BG008|Baseline|Total|Total of all reporting groups
10958434|NCT00847145|FG000|Participant Flow|12B12M (1a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
10958435|NCT00847145|FG001|Participant Flow|12B13M (1b)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
10958436|NCT00847145|FG002|Participant Flow|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
10958437|NCT00847145|FG003|Participant Flow|12M12B14B (2b)|Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
10958438|NCT00847145|FG004|Participant Flow|12B12M (3a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
10958439|NCT00847145|FG005|Participant Flow|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
10958440|NCT00847145|FG006|Participant Flow|12B12M_C (4a)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
10958441|NCT00847145|FG007|Participant Flow|12B13M_C (4b)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
10958442|NCT00847145|OG000|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
10958443|NCT00847145|OG001|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
10958444|NCT00847145|OG000|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine.
10958445|NCT00847145|OG001|Outcome|12M13B15B (2a)|Previously in the parent study subjects had received only routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age in the present study.
10958446|NCT00847145|OG000|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
10958447|NCT00847145|OG002|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
10958448|NCT00847145|OG003|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
10958449|NCT00847145|OG000|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
10963827|NCT00874497|OG000|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
10958450|NCT00847145|OG001|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine was given concomitantly at 12 months of age in the present study
10958451|NCT00847145|OG000|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
10958452|NCT00847145|OG001|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
10958453|NCT00847145|OG000|Outcome|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
10958454|NCT00847145|OG001|Outcome|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
10958455|NCT00847145|OG002|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
10958456|NCT00847145|OG003|Outcome|12B13M|Combination of Groups 12B13M (1b) and 12B13M (3b).
10958457|NCT00847145|OG000|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
10958458|NCT00847145|OG001|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
10958459|NCT00847145|OG002|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
10958460|NCT00847145|OG003|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
10958461|NCT00847145|EG000|Reported Event|12B12M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~This group is a combination of Groups 12B12M (1a) and 12B12M (3a) for safety data analysis purposes."
10958462|NCT00847145|EG001|Reported Event|12B13M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.~This group is a combination of Groups 12B13M (1b) and 12B13M (3b) for safety data analysis purposes."
10958463|NCT00847145|EG002|Reported Event|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
10958464|NCT00847145|EG003|Reported Event|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
10958465|NCT00847145|EG004|Reported Event|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
10958466|NCT00847145|EG005|Reported Event|12B13M_C (4b)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.~4b - rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
10958467|NCT00847171|BG000|Baseline|Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine|Patients receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
10958468|NCT00847171|FG000|Participant Flow|Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine|Patients receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
10958469|NCT00847171|OG000|Outcome|Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine|All patients receive weekly Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
10958470|NCT00847171|OG000|Outcome|Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine|Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
10963828|NCT00874497|OG001|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
10958471|NCT00847171|EG000|Reported Event|Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine|Patients receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
10958472|NCT00847197|BG000|Baseline|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
10958473|NCT00847197|BG001|Baseline|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
10958474|NCT00847197|BG002|Baseline|Total|Total of all reporting groups
10958475|NCT00847197|FG000|Participant Flow|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
10958476|NCT00847197|FG001|Participant Flow|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
10958477|NCT00847197|OG000|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
10958478|NCT00847197|OG001|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
10958479|NCT00847197|EG000|Reported Event|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
11179101|NCT02054481|EG003|Reported Event|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
11179102|NCT02054520|BG000|Baseline|Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab|"Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Ipilimumab"
11179103|NCT02054520|BG001|Baseline|Arm 2A Ipilimumab Alone|"Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.~Ipilimumab"
10958480|NCT00847197|EG001|Reported Event|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
10958481|NCT00847210|BG000|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
10958482|NCT00847210|BG001|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
10958483|NCT00847210|BG002|Baseline|Total|Total of all reporting groups
10958484|NCT00847210|FG000|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
10958485|NCT00847210|FG001|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
10958486|NCT00847210|OG000|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
10958487|NCT00847210|OG001|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
10958488|NCT00847210|EG000|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
10958489|NCT00847210|EG001|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
10958490|NCT00847288|BG000|Baseline|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
10958491|NCT00847288|BG001|Baseline|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
10958492|NCT00847288|BG002|Baseline|Total|Total of all reporting groups
10958493|NCT00847288|FG000|Participant Flow|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
10958494|NCT00847288|FG001|Participant Flow|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
10958495|NCT00847288|OG000|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
10958496|NCT00847288|OG001|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
10958497|NCT00847288|EG000|Reported Event|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
10958498|NCT00847288|EG001|Reported Event|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
10958499|NCT00847301|BG000|Baseline|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
10958500|NCT00847301|FG000|Participant Flow|Overall Study Design|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily
10958501|NCT00847301|OG000|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
10958502|NCT00847301|EG000|Reported Event|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
10963829|NCT00874497|EG000|Reported Event|Tetomilast 25 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
10963830|NCT00874497|EG001|Reported Event|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
11179104|NCT02054520|BG002|Baseline|Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab|"Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Nivolumab"
10958503|NCT00847379|BG000|Baseline|High-Dose Ataluren/High-Dose Ataluren|Participants who were randomized to receive high-dose ataluren in study PTC124-GD-007-DMD, continued to receive ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958504|NCT00847379|BG001|Baseline|Low-Dose Ataluren/High-Dose Ataluren|Participants who were randomized to receive low-dose ataluren in study PTC124-GD-007-DMD, received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
11179105|NCT02054520|BG003|Baseline|Arm 2B Nivolumab Alone|"Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks~Nivolumab"
11179106|NCT02054520|BG004|Baseline|Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab|"Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Pembrolizumab"
11179107|NCT02054520|BG005|Baseline|Arm 2C Pembrolizumab Alone|"Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks~Pembrolizumab"
11179108|NCT02054520|BG006|Baseline|Total|Total of all reporting groups
11179109|NCT02054520|FG000|Participant Flow|Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab|"Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Ipilimumab"
11179110|NCT02054520|FG001|Participant Flow|Arm 2A Ipilimumab Alone|"Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.~Ipilimumab"
11179111|NCT02054520|FG002|Participant Flow|Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab|"Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Nivolumab"
11179112|NCT02054520|FG003|Participant Flow|Arm 2B Nivolumab Alone|"Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks~Nivolumab"
11179113|NCT02054520|FG004|Participant Flow|Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab|"Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Pembrolizumab"
11179114|NCT02054520|FG005|Participant Flow|Arm 2C Pembrolizumab Alone|"Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks~Pembrolizumab"
11179115|NCT02054520|OG000|Outcome|Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab|"Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Ipilimumab"
11179116|NCT02054520|OG001|Outcome|Arm 2A Ipilimumab Alone|"Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.~Ipilimumab"
11179117|NCT02054520|OG002|Outcome|Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab|"Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Nivolumab"
11179118|NCT02054520|OG003|Outcome|Arm 2B Nivolumab Alone|"Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks~Nivolumab"
11179119|NCT02054520|OG004|Outcome|Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab|"Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Pembrolizumab"
11179120|NCT02054520|OG005|Outcome|Arm 2C Pembrolizumab Alone|"Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks~Pembrolizumab"
11179121|NCT02054520|EG000|Reported Event|Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab|"Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Ipilimumab"
10963831|NCT00874510|BG000|Baseline|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
11179122|NCT02054520|EG001|Reported Event|Arm 2A Ipilimumab Alone|"Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.~Ipilimumab"
11179123|NCT02054520|EG002|Reported Event|Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab|"Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Nivolumab"
11179124|NCT02054520|EG003|Reported Event|Arm 2B Nivolumab Alone|"Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks~Nivolumab"
11179125|NCT02054520|EG004|Reported Event|Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab|"Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.~HyperAcute®-Melanoma (HAM) Immunotherapy~Pembrolizumab"
10958505|NCT00847379|BG002|Baseline|Placebo/High-Dose Ataluren|Participants who were randomized to receive placebo in study PTC124-GD-007-DMD, received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of placebo at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958506|NCT00847379|BG003|Baseline|Total|Total of all reporting groups
10958507|NCT00847379|FG000|Participant Flow|High-Dose Ataluren/High-Dose Ataluren|Participants who were randomized to receive high-dose ataluren in study PTC124-GD-007-DMD, continued to receive ataluren suspension orally 3 times a day (TID), 20 milligrams/kilogram (mg/kg) at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit (Week 48) in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958508|NCT00847379|FG001|Participant Flow|Low-Dose Ataluren/High-Dose Ataluren|Participants who were randomized to receive low-dose ataluren in study PTC124-GD-007-DMD, received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958509|NCT00847379|FG002|Participant Flow|Placebo/High-Dose Ataluren|Participants who were randomized to receive placebo in study PTC124-GD-007-DMD, received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of placebo at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958510|NCT00847379|OG000|Outcome|High-Dose Ataluren/High-Dose Ataluren|Participants who were randomized to receive high-dose ataluren in study PTC124-GD-007-DMD, continued to receive ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958511|NCT00847379|OG001|Outcome|Low-Dose Ataluren/High-Dose Ataluren|Participants who were randomized to receive low-dose ataluren in study PTC124-GD-007-DMD, received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958512|NCT00847379|OG002|Outcome|Placebo/High-Dose Ataluren|Participants who were randomized to receive placebo in study PTC124-GD-007-DMD, received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of placebo at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958513|NCT00847379|OG003|Outcome|Overall Participants: High-Dose Ataluren|All participants received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958514|NCT00847379|EG000|Reported Event|High-Dose Ataluren/High-Dose Ataluren|Participants who were randomized to receive high-dose ataluren in study PTC124-GD-007-DMD, continued to receive ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
11179126|NCT02054520|EG005|Reported Event|Arm 2C Pembrolizumab Alone|"Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks~Pembrolizumab"
11179127|NCT02054572|BG000|Baseline|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
11179128|NCT02054572|FG000|Participant Flow|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
11179129|NCT02054572|OG000|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
11179130|NCT02054572|EG000|Reported Event|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by IV bolus at the end of hemodialysis on day 1.
11179131|NCT02054702|BG000|Baseline|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
11179132|NCT02054702|BG001|Baseline|Arpiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
11179133|NCT02054702|BG002|Baseline|Total|Total of all reporting groups
11179134|NCT02054702|FG000|Participant Flow|Brexpiprazole|Participants were administered brexpiprazole tablets orally, once daily (QD) starting dose at 1 milligram per day (mg/day) for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
11179135|NCT02054702|FG001|Participant Flow|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
11179136|NCT02054702|OG000|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
11179137|NCT02054702|OG001|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
11179138|NCT02054702|EG000|Reported Event|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
11179139|NCT02054702|EG001|Reported Event|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
11179140|NCT02054715|BG000|Baseline|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
11179141|NCT02054715|BG001|Baseline|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
11179142|NCT02054715|BG002|Baseline|Total|Total of all reporting groups
11179143|NCT02054715|FG000|Participant Flow|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
11179144|NCT02054715|FG001|Participant Flow|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
11179145|NCT02054715|OG000|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
11179146|NCT02054715|OG001|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
11179147|NCT02054715|EG000|Reported Event|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
11179148|NCT02054715|EG001|Reported Event|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
11179149|NCT02054754|BG000|Baseline|Dexanabinol|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
11179150|NCT02054754|BG001|Baseline|Placebo|"Single oral dose of matching placebo~Placebo"
11179151|NCT02054754|BG002|Baseline|Total|Total of all reporting groups
11179152|NCT02054754|FG000|Participant Flow|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol at Dose Level 1~Dexanabinol: Oral formulation of dexanabinol"
11179153|NCT02054754|FG001|Participant Flow|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol at Dose level 2~Dexanabinol: Oral formulation of dexanabinol"
11179154|NCT02054754|FG002|Participant Flow|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol at Dose level 3~Dexanabinol: Oral formulation of dexanabinol"
11179155|NCT02054754|FG003|Participant Flow|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol at Dose level 4~Dexanabinol: Oral formulation of dexanabinol"
11179156|NCT02054754|FG004|Participant Flow|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol at Dose level 5~Dexanabinol: Oral formulation of dexanabinol"
11179157|NCT02054754|FG005|Participant Flow|Placebo|"Single oral dose of matching placebo~Placebo"
11179158|NCT02054754|OG000|Outcome|Dexanabinol|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
11179159|NCT02054754|OG001|Outcome|Placebo|"Single oral dose of matching placebo~Placebo"
11179160|NCT02054754|OG000|Outcome|Dexanabinol Dose Level 1|
11179161|NCT02054754|OG001|Outcome|Dose Level 2|
11179162|NCT02054754|OG002|Outcome|Dose Level 3|
11179163|NCT02054754|OG003|Outcome|Dose Level 4|
11179164|NCT02054754|OG004|Outcome|Dose Level 5|
10958515|NCT00847379|EG001|Reported Event|Low-Dose Ataluren/High-Dose Ataluren|Participants who were randomized to receive low-dose ataluren in study PTC124-GD-007-DMD, received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958516|NCT00847379|EG002|Reported Event|Placebo/High-Dose Ataluren|Participants who were randomized to receive placebo in study PTC124-GD-007-DMD, received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of placebo at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958517|NCT00847379|EG003|Reported Event|Overall Participants: High-Dose Ataluren|All participants received ataluren suspension orally TID, 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, was initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose was increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level was well tolerated.
10958518|NCT00847522|BG000|Baseline|All Patients|"All participants enrolled.~Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps."
10958519|NCT00847522|FG000|Participant Flow|All Patients|"Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.~Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps."
10958520|NCT00847522|OG000|Outcome|All Patients|"Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.~Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps."
10958521|NCT00847522|EG000|Reported Event|Phase I/II Patients|Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
10958522|NCT00847535|BG000|Baseline|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
10958523|NCT00847535|FG000|Participant Flow|Part I: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
10958524|NCT00847535|FG001|Participant Flow|Part I: Periurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
10958525|NCT00847535|FG002|Participant Flow|Part II: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
10958526|NCT00847535|OG000|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
10958527|NCT00847535|OG000|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
10958528|NCT00847535|EG000|Reported Event|Patients|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women
10958529|NCT00847561|BG000|Baseline|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
11179165|NCT02054754|EG000|Reported Event|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
11179166|NCT02054754|EG001|Reported Event|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
11179167|NCT02054754|EG002|Reported Event|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol~Dexanabinol: Oral formuulation of dexanabinol"
11179168|NCT02054754|EG003|Reported Event|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
11179169|NCT02054754|EG004|Reported Event|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
11179170|NCT02054754|EG005|Reported Event|Placebo|"Single oral dose of matching placebo~Placebo"
11179171|NCT02054897|BG000|Baseline|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
11179172|NCT02054897|BG001|Baseline|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
11179173|NCT02054897|BG002|Baseline|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
10958530|NCT00847561|BG001|Baseline|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
11179174|NCT02054897|BG003|Baseline|Total|Total of all reporting groups
11179175|NCT02054897|FG000|Participant Flow|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly subcutaneous (s.c.; under the skin) injections for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.
11179176|NCT02054897|FG001|Participant Flow|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
11179177|NCT02054897|FG002|Participant Flow|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
11179178|NCT02054897|OG000|Outcome|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
11179179|NCT02054897|OG001|Outcome|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
11179180|NCT02054897|OG002|Outcome|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
11179181|NCT02054897|EG000|Reported Event|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
11179182|NCT02054897|EG001|Reported Event|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
11179183|NCT02054897|EG002|Reported Event|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
11179184|NCT02055118|BG000|Baseline|No IT Treatment|Participants aged 3 to < 18 years received Elaprase therapy as standard of care for 12 months.
10958531|NCT00847561|BG002|Baseline|Total|Total of all reporting groups
11179185|NCT02055118|BG001|Baseline|IT Treatment|Participants aged 3 to < 18 years received IT injections of 10 mg Idursulfase-IT once monthly for 12 months through SOPH-A-PORT Mini S IDDD along with Elaprase.
11179186|NCT02055118|BG002|Baseline|Substudy|Participants aged less than 3 years received Idursulfase-IT monthly once for 12 months along with Elaprase at a dose of 5 mg if aged <= 8 months; 7.5 mg if aged > 8 to 30 months and 10 mg if aged > 30 months to 3 years.
11179187|NCT02055118|BG003|Baseline|Total|Total of all reporting groups
11179188|NCT02055118|FG000|Participant Flow|No IT Treatment|Participants aged 3 to less than (<) 18 years received Elaprase therapy as standard of care for 12 months.
10958532|NCT00847561|FG000|Participant Flow|Family-based CBT|"Family-based Cognitive Behavioral Therapy (CBT). Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
10958533|NCT00847561|FG001|Participant Flow|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
10958534|NCT00847561|OG000|Outcome|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
10958535|NCT00847561|OG001|Outcome|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
10958536|NCT00847561|EG000|Reported Event|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
10958537|NCT00847561|EG001|Reported Event|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
10958538|NCT00847587|BG000|Baseline|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
10958539|NCT00847587|BG001|Baseline|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
10958540|NCT00847587|BG002|Baseline|Total|Total of all reporting groups
10958541|NCT00847587|FG000|Participant Flow|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
10958542|NCT00847587|FG001|Participant Flow|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
10958543|NCT00847587|OG000|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
10958544|NCT00847587|OG001|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
11341779|NCT03688282|BG000|Baseline|Sham & 30 Minute Treatment|"Visit 1:~Device will be worn but not turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.~Visit 2:~Device will be worn and turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips."
10958545|NCT00847587|EG000|Reported Event|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
10958546|NCT00847587|EG001|Reported Event|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
10958547|NCT00847613|BG000|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
10958548|NCT00847613|BG001|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
10958549|NCT00847613|BG002|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
10958550|NCT00847613|BG003|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
10958551|NCT00847613|BG004|Baseline|Total|Total of all reporting groups
10958552|NCT00847613|FG000|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
10958553|NCT00847613|FG001|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
10958554|NCT00847613|FG002|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
10958555|NCT00847613|FG003|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
10958556|NCT00847613|OG000|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
10958557|NCT00847613|OG001|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
10958558|NCT00847613|OG002|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
10958559|NCT00847613|OG002|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
10958560|NCT00847613|OG003|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
11179189|NCT02055118|FG001|Participant Flow|IT Treatment|Participants aged 3 to < 18 years received intrathecal (IT) injections of 10 milligram (mg) Idursulfase-IT once monthly for 12 months through SOPH-A-PORT Mini S intrathecal drug delivery device (IDDD) along with Elaprase.
10958561|NCT00847613|OG003|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
10958562|NCT00847613|OG002|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
11179190|NCT02055118|FG002|Participant Flow|Substudy|Participants aged less than 3 years received Idursulfase-IT monthly once for 12 months along with Elaprase at a dose of 5 mg if aged less than or equal to (<=) 8 months; 7.5 mg if aged greater than (>) 8 to 30 months and 10 mg if aged > 30 months to 3 years.
11179191|NCT02055118|OG000|Outcome|No IT Treatment|Participants aged 3 to < 18 years received Elaprase therapy as standard of care for 12 months.
11179192|NCT02055118|OG001|Outcome|IT Treatment|Participants aged 3 to < 18 years received IT injections of 10 mg Idursulfase-IT once monthly for 12 months through SOPH-A-PORT Mini S IDDD along with Elaprase.
11179193|NCT02055118|OG000|Outcome|IT Treatment|Participants aged 3 to < 18 years received IT injections of 10 mg Idursulfase-IT once monthly for 12 months through SOPH-A-PORT Mini S IDDD along with Elaprase.
11179194|NCT02055118|OG000|Outcome|Substudy|Participants aged less than 3 years received Idursulfase-IT monthly once for 12 months along with Elaprase at a dose of 5 mg if aged less than or equal to (<=) 8 months; 7.5 mg if aged greater than (>) 8 to 30 months and 10 mg if aged > 30 months to 3 years.
11179195|NCT02055118|EG000|Reported Event|No IT Treatment|Participants aged 3 to < 18 years received Elaprase therapy as standard of care for 12 months.
10958563|NCT00847613|EG000|Reported Event|CP-690,550 5 mg (Up To Month 3)|Participants received CP-690,550 5 mg tablet orally twice daily up to Month 3.
10958564|NCT00847613|EG001|Reported Event|CP-690,550 10 mg (Up to Month 3)|Participants received CP-690,550 10 mg tablet orally twice daily up to Month 3.
10958565|NCT00847613|EG002|Reported Event|Placebo (Up to Month 3)|Participants received placebo matched to CP-690,550 tablet orally twice daily up to Month 3.
10958566|NCT00847613|EG003|Reported Event|CP-690,550 5 mg (Month 3 to 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 3, received CP-690,550 5 mg tablet orally twice daily from Month 3 to 6.
10958567|NCT00847613|EG004|Reported Event|CP-690,550 10 mg (Month 3 to 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 3, received CP-690,550 10 mg tablet orally twice daily from Month 3 to 6.
10958568|NCT00847613|EG005|Reported Event|Placebo (Month 3 to 6)|Participants received placebo matched to CP-690,550 tablet orally twice daily from Month 3 to 6.
11179196|NCT02055118|EG001|Reported Event|IT Treatment|Participants aged 3 to < 18 years received IT injections of 10 mg Idursulfase-IT once monthly for 12 months through SOPH-A-PORT Mini S IDDD along with Elaprase.
11179197|NCT02055118|EG002|Reported Event|Substudy|Participants aged less than 3 years received Idursulfase-IT monthly once for 12 months along with Elaprase at a dose of 5 mg if aged <= 8 months; 7.5 mg if aged > 8 to 30 months and 10 mg if aged > 30 months to 3 years.
11179198|NCT02055157|BG000|Baseline|Cohort 1|"Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179199|NCT02055157|BG001|Baseline|Cohort 2|"Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179200|NCT02055157|BG002|Baseline|Cohort 3|"Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179201|NCT02055157|BG003|Baseline|Cohort 4|"Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179202|NCT02055157|BG004|Baseline|Total|Total of all reporting groups
10958569|NCT00847613|EG006|Reported Event|CP-690,550 5 mg (Post Month 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 6, received CP-690,550 5 mg tablet orally twice daily from Month 6 to 24.
10958570|NCT00847613|EG007|Reported Event|CP-690,550 10 mg (Post Month 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 6, received CP-690,550 10 mg tablet orally twice daily from Month 6 to 24.
10958571|NCT00847626|BG000|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958572|NCT00847626|BG001|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958573|NCT00847626|BG002|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958574|NCT00847626|BG003|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958575|NCT00847626|BG004|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958576|NCT00847626|BG005|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958577|NCT00847626|BG006|Baseline|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958578|NCT00847626|BG007|Baseline|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958579|NCT00847626|BG008|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958580|NCT00847626|BG009|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958581|NCT00847626|BG010|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958582|NCT00847626|BG011|Baseline|Total|Total of all reporting groups
10958583|NCT00847626|FG000|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958584|NCT00847626|FG001|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958585|NCT00847626|FG002|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958586|NCT00847626|FG003|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958587|NCT00847626|FG004|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958588|NCT00847626|FG005|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958589|NCT00847626|FG006|Participant Flow|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958590|NCT00847626|FG007|Participant Flow|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958591|NCT00847626|FG008|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958592|NCT00847626|FG009|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958593|NCT00847626|FG010|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958594|NCT00847626|OG000|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.~OR~Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
10958595|NCT00847626|OG001|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958596|NCT00847626|OG002|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958597|NCT00847626|OG000|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958598|NCT00847626|OG001|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958599|NCT00847626|OG002|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958600|NCT00847626|OG003|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958601|NCT00847626|OG004|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958602|NCT00847626|OG005|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958603|NCT00847626|OG006|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958604|NCT00847626|OG007|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958605|NCT00847626|OG008|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958606|NCT00847626|OG009|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958607|NCT00847626|OG010|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958608|NCT00847626|EG000|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958609|NCT00847626|EG001|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958610|NCT00847626|EG002|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958611|NCT00847626|EG003|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958612|NCT00847626|EG004|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958613|NCT00847626|EG005|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958614|NCT00847626|EG006|Reported Event|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
10958615|NCT00847626|EG007|Reported Event|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
10958616|NCT00847626|EG008|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958617|NCT00847626|EG009|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958618|NCT00847626|EG010|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
10958619|NCT00847665|BG000|Baseline|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
10958620|NCT00847665|BG001|Baseline|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
10958621|NCT00847665|BG002|Baseline|Total|Total of all reporting groups
10958622|NCT00847665|FG000|Participant Flow|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
10958623|NCT00847665|FG001|Participant Flow|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
10958624|NCT00847665|OG000|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
10958625|NCT00847665|OG001|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
10958626|NCT00847665|EG000|Reported Event|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
10958627|NCT00847665|EG001|Reported Event|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
10958628|NCT00847704|BG000|Baseline|Test Group|"Device: Assisted movement and enhanced sensation~Assisted movement and enhanced sensation: Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.~Assisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments."
10958629|NCT00847704|FG000|Participant Flow|Test Group|Device: Assisted movement and enhanced sensation
10958630|NCT00847704|OG000|Outcome|Test Group|Group receiving AMES therapy
10958631|NCT00847704|EG000|Reported Event|Test Treatment Group|Device: Subjects receiving AMES treatments.
10958632|NCT00847730|BG000|Baseline|V.A.C Bridge Dressing|This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
10958633|NCT00847730|FG000|Participant Flow|V.A.C Bridge Dressing|This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
10958634|NCT00847730|OG000|Outcome|VAC GranuFoam Bridge Dressing|This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
10958635|NCT00847730|EG000|Reported Event|VAC GranuFoam Bridge Dressing|This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
10958636|NCT00847808|BG000|Baseline|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
10958637|NCT00847808|FG000|Participant Flow|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
10958638|NCT00847808|OG000|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
10958639|NCT00847808|EG000|Reported Event|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
11179203|NCT02055157|FG000|Participant Flow|Cohort 1|"Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179204|NCT02055157|FG001|Participant Flow|Cohort 2|"Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179205|NCT02055157|FG002|Participant Flow|Cohort 3|"Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179206|NCT02055157|FG003|Participant Flow|Cohort 4|"Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179207|NCT02055157|OG000|Outcome|Cohort 1|"Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179208|NCT02055157|OG001|Outcome|Cohort 2|"Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179209|NCT02055157|OG002|Outcome|Cohort 3|"Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179210|NCT02055157|OG003|Outcome|Cohort 4|"Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179211|NCT02055157|OG000|Outcome|Cohort 3|"Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
10958640|NCT00847886|BG000|Baseline|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
10958641|NCT00847886|BG001|Baseline|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
10958642|NCT00847886|BG002|Baseline|Total|Total of all reporting groups
10958643|NCT00847886|FG000|Participant Flow|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
10958644|NCT00847886|FG001|Participant Flow|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
10958645|NCT00847886|OG000|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
10958646|NCT00847886|OG001|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
10958647|NCT00847886|EG000|Reported Event|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
10958648|NCT00847886|EG001|Reported Event|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
10958649|NCT00847912|BG000|Baseline|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
10958650|NCT00847912|BG001|Baseline|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
11179212|NCT02055157|OG001|Outcome|Cohort 4|"Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months."
10958651|NCT00847912|BG002|Baseline|Total|Total of all reporting groups
10958652|NCT00847912|FG000|Participant Flow|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
10958653|NCT00847912|FG001|Participant Flow|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
10958654|NCT00847912|OG000|Outcome|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-fluorouracil (5-FU) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
10958655|NCT00847912|OG001|Outcome|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
10958656|NCT00847912|OG000|Outcome|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
10958657|NCT00847912|EG000|Reported Event|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
10958658|NCT00847912|EG001|Reported Event|Arm 2: Placebo|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
10958659|NCT00847938|BG000|Baseline|Neostigmine 40 µg/kg|"neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg~neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958660|NCT00847938|BG001|Baseline|Neostigmine 20 µg/kg|"neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg~neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958661|NCT00847938|BG002|Baseline|Neostigmine 10 µg/kg|"neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg~neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958662|NCT00847938|BG003|Baseline|Placebo|no injection of neostigmine
10958663|NCT00847938|BG004|Baseline|Total|Total of all reporting groups
10958664|NCT00847938|FG000|Participant Flow|Neostigmine 40 µg/kg|"neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg~neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958665|NCT00847938|FG001|Participant Flow|Neostigmine 20 µg/kg|"neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg~neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958666|NCT00847938|FG002|Participant Flow|Neostigmine 10 µg/kg|"neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg~neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958667|NCT00847938|FG003|Participant Flow|Placebo|no injection of neostigmine
10958668|NCT00847938|OG000|Outcome|Neostigmine 40 µg/kg|"neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg~neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958669|NCT00847938|OG001|Outcome|Neostigmine 20 µg/kg|"neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg~neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958670|NCT00847938|OG002|Outcome|Neostigmine 10 µg/kg|"neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg~neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958671|NCT00847938|OG003|Outcome|Placebo|no injection of neostigmine
10958672|NCT00847938|EG000|Reported Event|Neostigmine 40 µg/kg|"neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg~neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958673|NCT00847938|EG001|Reported Event|Neostigmine 20 µg/kg|"neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg~neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
11179213|NCT02055157|OG000|Outcome|Cohort 2|"Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.~18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months."
11179214|NCT02055157|EG000|Reported Event|Initial 6-Months Period 2.5 µg/kg.|BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.
11179215|NCT02055157|EG001|Reported Event|Initial 6-Months Period 7.5 µg/kg.|BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.
11179216|NCT02055157|EG002|Reported Event|Initial 6-Months Period 15 µg/kg.|BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.
11179217|NCT02055157|EG003|Reported Event|Initial 6-Months Period 30 µg/kg.|BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.
11179218|NCT02055157|EG004|Reported Event|Extension Period 2.5 µg/kg.|BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 135.4 days.
11179219|NCT02055157|EG005|Reported Event|Extension Period 7.5 µg/kg.|BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 83.1 days.
11179220|NCT02055157|EG006|Reported Event|Extension Period 15 µg/kg.|BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for mean duration of 464.7 days.
11179221|NCT02055157|EG007|Reported Event|Extension Period 30 µg/kg.|BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for mean duration of 546.4 days.
11179222|NCT02055157|EG008|Reported Event|Entire Study Period 2.5 µg/kg.|BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 298.8 days.
11179223|NCT02055157|EG009|Reported Event|Entire Study Period 7.5 µg/kg.|BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 175.5 days.
11179224|NCT02055157|EG010|Reported Event|Entire Study Period 15 µg/kg.|BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for mean duration of 549.6 days.
11179225|NCT02055157|EG011|Reported Event|Entire Study Period 30 µg/kg.|BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for mean duration of 650.9 days.
11179226|NCT02055352|BG000|Baseline|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
11179227|NCT02055352|BG001|Baseline|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
11179228|NCT02055352|BG002|Baseline|Total|Total of all reporting groups
11179229|NCT02055352|FG000|Participant Flow|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
11179230|NCT02055352|FG001|Participant Flow|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
11179231|NCT02055352|OG000|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
11179232|NCT02055352|OG001|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
11179233|NCT02055352|EG000|Reported Event|Budesonide / Indacaterol (A)|Budesonide / Indacaterol (A)
11179234|NCT02055352|EG001|Reported Event|Fluticasone / Salmeterol (B)|Fluticasone / Salmeterol (B)
11179235|NCT02055365|BG000|Baseline|Hepatitis B Vaccination|"All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).~Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant)."
11179236|NCT02055365|FG000|Participant Flow|Hepatitis B Vaccination|"All subjects will receive the standard 3-dose course of Recombivax Hepatitis B (HB) (Merck) - Hepatitis B Vaccine (Recombinant).~Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant)."
11179237|NCT02055365|OG000|Outcome|Day 1|Differentially expressed genes at Day 1 versus pre-vaccination baseline (p<0.05).
11179238|NCT02055365|OG001|Outcome|Day 3|Differentially expressed genes at Day 3 versus pre-vaccination baseline (p<0.05).
11179239|NCT02055365|OG002|Outcome|Week 1|Differentially expressed genes at Week 1 versus pre-vaccination baseline (p<0.05).
11179240|NCT02055365|OG003|Outcome|Week 2|Differentially expressed genes at Week 2 versus pre-vaccination baseline (p<0.05).
11179241|NCT02055365|OG000|Outcome|Day 1|Significantly Differentially expressed genes at Day 1 versus pre-vaccination baseline (FDR<0.05).
10958674|NCT00847938|EG002|Reported Event|Neostigmine 10 µg/kg|"neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg~neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %"
10958675|NCT00847938|EG003|Reported Event|Placebo|no injection of neostigmine
10958676|NCT00848016|BG000|Baseline|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10958677|NCT00848016|FG000|Participant Flow|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10958678|NCT00848016|OG000|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10958679|NCT00848016|EG000|Reported Event|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10958680|NCT00848042|BG000|Baseline|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
10958681|NCT00848042|BG001|Baseline|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
10958682|NCT00848042|BG002|Baseline|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
10958683|NCT00848042|BG003|Baseline|Total|Total of all reporting groups
10958684|NCT00848042|FG000|Participant Flow|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
10958685|NCT00848042|FG001|Participant Flow|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
11179242|NCT02055365|OG001|Outcome|Day 3|Significantly Differentially expressed genes at Day 3 versus pre-vaccination baseline (FDR<0.05).
10958686|NCT00848042|FG002|Participant Flow|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
11179243|NCT02055365|OG002|Outcome|Week 1|Significantly Differentially expressed genes at Week 1 versus pre-vaccination baseline (FDR<0.05).
11179244|NCT02055365|OG003|Outcome|Week 2|Significantly Differentially expressed genes at Week 2 versus pre-vaccination baseline (FDR<0.05).
11179245|NCT02055365|EG000|Reported Event|Hepatitis B Vaccination|"All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).~Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant)."
11179246|NCT02055404|BG000|Baseline|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
11179247|NCT02055404|FG000|Participant Flow|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
11179248|NCT02055404|OG000|Outcome|S1 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
10958687|NCT00848042|OG000|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
10958688|NCT00848042|OG001|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
10958689|NCT00848042|OG002|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
10958690|NCT00848042|EG000|Reported Event|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
10958691|NCT00848042|EG001|Reported Event|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
10958692|NCT00848042|EG002|Reported Event|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
10958693|NCT00848081|BG000|Baseline|Placebo|Placebo by mouth once daily for 12 weeks
10958694|NCT00848081|BG001|Baseline|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
10958695|NCT00848081|BG002|Baseline|Total|Total of all reporting groups
10958696|NCT00848081|FG000|Participant Flow|Placebo|Placebo by mouth once daily for 12 weeks
10958697|NCT00848081|FG001|Participant Flow|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
10958698|NCT00848081|OG000|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
10958699|NCT00848081|OG001|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
10958700|NCT00848081|EG000|Reported Event|Placebo|Placebo by mouth once daily for 12 weeks
10958701|NCT00848081|EG001|Reported Event|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
10958702|NCT00848107|BG000|Baseline|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
10958703|NCT00848107|FG000|Participant Flow|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
10958704|NCT00848107|OG000|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
10958705|NCT00848107|EG000|Reported Event|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
10958706|NCT00848120|BG000|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
10958707|NCT00848120|FG000|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 24 weeks.
11179249|NCT02055404|OG001|Outcome|S2 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
11179250|NCT02055404|OG002|Outcome|S3 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
10958708|NCT00848120|OG000|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
10958709|NCT00848120|EG000|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
10958710|NCT00848172|BG000|Baseline|Sequence OA / Placebo|First day: octanoic acid Second day: placebo
10958711|NCT00848172|BG001|Baseline|Sequence Placebo / OA|First day: placebo Second day: octanoic acid
10958712|NCT00848172|BG002|Baseline|Total|Total of all reporting groups
10958713|NCT00848172|FG000|Participant Flow|Sequence OA / Placebo|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received a single oral dose of 4 mg/kg OA on the second day of Visit 2, and matching Placebo on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
10958714|NCT00848172|FG001|Participant Flow|Sequence Placebo / OA|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received Placebo on the second day of Visit 2, and a single oral dose of 4 mg/kg OA on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
10958715|NCT00848172|OG000|Outcome|Octanoic Acid|
10958716|NCT00848172|OG001|Outcome|Placebo|
10958717|NCT00848172|OG000|Outcome|Octanoic Acid Tmax|
10958718|NCT00848172|OG000|Outcome|Octanoic Acid AUC|
10958719|NCT00848172|EG000|Reported Event|Octanoic Acid|
10958720|NCT00848172|EG001|Reported Event|Placebo|
10958721|NCT00848172|EG002|Reported Event|Non-drug Related|AE was considered to be non-drug related, if no temporal connection was present between AE occurrence and drug administration (e.g. if AE occurred during the study, but prior to drug-administration), or an AE was clearly related to a study procedure (e.g. PICC line) rather than the study drug.
10958722|NCT00848185|BG000|Baseline|Antagonist-hCG to Trigger|Protocol with antagonist and hCG to trigger oocyte maturation
10958723|NCT00848185|BG001|Baseline|Antagonist-aGnRH to Trigger|Protocol with antagonist and 0.2 mg triptorelin to trigger oocyte maturation
10958724|NCT00848185|BG002|Baseline|Long Protocol-hCG|Long Protocol and hCG to trigger oocyte maturation
11179251|NCT02055404|OG003|Outcome|S4 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
10958725|NCT00848185|BG003|Baseline|Total|Total of all reporting groups
10958726|NCT00848185|FG000|Participant Flow|Antagonist Trigger With aGnRH|Protocol with antagonist and 0,2 mg triptorelin to trigger oocyte maturation
10958727|NCT00848185|FG001|Participant Flow|Antagonist Trigger With hCG|Protocol with antagonist and hCG to trigger oocyte maturation
10958728|NCT00848185|FG002|Participant Flow|Long Protocol hCG|Long Protocol with hCG to trigger oocyte maturation
10958729|NCT00848185|OG000|Outcome|Antagonist-hCG Levels of VEGF|Levels of VEGF in folicular fluid of patients with antagonist protocol anf hCG for triggering
10958730|NCT00848185|OG001|Outcome|Antagonist-aGnRH Levels of VEGF|Levels of VEGF in folicular fluid of patients with antagonist protocol and aGnRH for triggering
10958731|NCT00848185|OG002|Outcome|Long Protocol- hCG|Levels of VEGF in folicular fluid of patients with long protocol anf hCG for triggering
10958732|NCT00848185|EG000|Reported Event|GnRH Antagonist - hCG Trigger|GnRH antagonist protocol and hCG trigger
10958733|NCT00848185|EG001|Reported Event|GnRH Antagonist Triptorelin Trigger|GnRH antagonist protocol and triptorelin trigger
10958734|NCT00848185|EG002|Reported Event|Long Protocol - hCG Trigger|Long protocol and hCG trigger as control
10958735|NCT00848198|BG000|Baseline|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
10958736|NCT00848198|FG000|Participant Flow|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
10958737|NCT00848198|OG000|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
10958738|NCT00848198|OG001|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
10958739|NCT00848198|OG000|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
10958740|NCT00848198|OG001|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
10958741|NCT00848198|OG002|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
10958742|NCT00848198|EG000|Reported Event|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
10958743|NCT00848211|BG000|Baseline|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958744|NCT00848211|BG001|Baseline|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958745|NCT00848211|BG002|Baseline|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958746|NCT00848211|BG003|Baseline|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958747|NCT00848211|BG004|Baseline|Total|Total of all reporting groups
10958748|NCT00848211|FG000|Participant Flow|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958749|NCT00848211|FG001|Participant Flow|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958750|NCT00848211|FG002|Participant Flow|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958751|NCT00848211|FG003|Participant Flow|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958752|NCT00848211|OG000|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958753|NCT00848211|OG001|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958754|NCT00848211|OG002|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958755|NCT00848211|OG003|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958756|NCT00848211|EG000|Reported Event|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958757|NCT00848211|EG001|Reported Event|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958758|NCT00848211|EG002|Reported Event|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
11179252|NCT02055404|OG004|Outcome|S5 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
11179253|NCT02055404|OG005|Outcome|S6 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
10958759|NCT00848211|EG003|Reported Event|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
10958760|NCT00848237|BG000|Baseline|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
10958761|NCT00848237|FG000|Participant Flow|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
10958762|NCT00848237|OG000|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
11179254|NCT02055404|OG006|Outcome|S7 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
11179255|NCT02055404|OG007|Outcome|S8 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
11179256|NCT02055404|OG008|Outcome|Control|Etafilcon A toric contact lens
10958763|NCT00848237|EG000|Reported Event|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
10958764|NCT00848250|BG000|Baseline|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
10958765|NCT00848250|BG001|Baseline|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
10958766|NCT00848250|BG002|Baseline|Total|Total of all reporting groups
11179257|NCT02055404|EG000|Reported Event|Delefilcon A|Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration.
11179258|NCT02055404|EG001|Reported Event|Etafilcon A|Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration
11179259|NCT02055430|BG000|Baseline|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
11179260|NCT02055430|BG001|Baseline|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
11179261|NCT02055430|BG002|Baseline|Total|Total of all reporting groups
11179262|NCT02055430|FG000|Participant Flow|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
11179263|NCT02055430|FG001|Participant Flow|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
10958767|NCT00848250|FG000|Participant Flow|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
11179264|NCT02055430|OG000|Outcome|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
10958768|NCT00848250|FG001|Participant Flow|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
10958769|NCT00848250|OG000|Outcome|ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
10958770|NCT00848250|OG001|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
10958771|NCT00848250|OG000|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
10958772|NCT00848250|EG000|Reported Event|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
10958773|NCT00848250|EG001|Reported Event|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
10958774|NCT00848354|BG000|Baseline|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958775|NCT00848354|BG001|Baseline|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958776|NCT00848354|BG002|Baseline|Total|Total of all reporting groups
10958777|NCT00848354|FG000|Participant Flow|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection subcutaneously (s.c.) once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958778|NCT00848354|FG001|Participant Flow|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958779|NCT00848354|OG000|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
11179265|NCT02055430|OG001|Outcome|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
11179266|NCT02055430|EG000|Reported Event|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
10958780|NCT00848354|OG001|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958781|NCT00848354|EG000|Reported Event|Etanercept + Methotrexate Phase 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958782|NCT00848354|EG001|Reported Event|DMARD + Methotrexate Phase 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958783|NCT00848354|EG002|Reported Event|Etanercept + Methotrexate Phase 2 Year 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958784|NCT00848354|EG003|Reported Event|DMARD + Methotrexate Phase 2 Year 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958785|NCT00848354|EG004|Reported Event|Etanercept + Methotrexate Phase 2 Year 2|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958786|NCT00848354|EG005|Reported Event|DMARD + Methotrexate Phase 2 Year 2|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen.
10958787|NCT00848367|BG000|Baseline|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
10958788|NCT00848367|BG001|Baseline|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
10958789|NCT00848367|BG002|Baseline|Total|Total of all reporting groups
10958790|NCT00848367|FG000|Participant Flow|Low Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety (i.e. others that scored below the cut off). The type of therapy administered to this group was Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
11179267|NCT02055430|EG001|Reported Event|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
10958791|NCT00848367|FG001|Participant Flow|High Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety (i.e. others that scored above the cut off). The type of therapy provided was called Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
10958792|NCT00848367|OG000|Outcome|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
10958793|NCT00848367|OG001|Outcome|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
10958794|NCT00848367|OG000|Outcome|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
10958795|NCT00848367|OG001|Outcome|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
10958796|NCT00848367|EG000|Reported Event|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
10958797|NCT00848367|EG001|Reported Event|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
10958798|NCT00848393|BG000|Baseline|Fentanyl (High Dose)|"patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.~Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision."
10958799|NCT00848393|BG001|Baseline|Fentanyl (Low Dose)|"patients in this group will receive a total of 10mcg/kg of fentanyl. half the dose will be given at induction and the second half will be given before incision~Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of fentanyl. half the dose will be given at induction and the second half before incision."
10958800|NCT00848393|BG002|Baseline|Fentanyl (Low Dose) + Dexmedetomidine|"patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.~Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision."
10958801|NCT00848393|BG003|Baseline|Total|Total of all reporting groups
10958802|NCT00848393|FG000|Participant Flow|Fentanyl (High Dose)|"Patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.~Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision."
10958803|NCT00848393|FG001|Participant Flow|Fentanyl (Low Dose)|"Patients in this arm will receive a total of 10 mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision~Fentanyl (Low Dose): patients will receive a total of 10 mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision."
10958804|NCT00848393|FG002|Participant Flow|Fentanyl (Low Dose) + Dexmedetomidine|"Patients in this arm will receive a total of 10 mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1 mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.~Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1 mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5 mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision."
10958805|NCT00848393|OG000|Outcome|Fentanyl (High Dose)|"patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.~Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision."
10958806|NCT00848393|OG001|Outcome|Fentanyl (Low Dose)|"patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision~Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision."
10958807|NCT00848393|OG002|Outcome|Fentanyl (Low Dose) + Dexmedetomidine|"patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.~Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr.in addition this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision."
11179268|NCT02055638|BG000|Baseline|SRX246|"SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks~SRX246: capsules"
10958808|NCT00848393|OG002|Outcome|Fentanyl (Low Dose) + Dexmedetomidine|"patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.~Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision."
10958809|NCT00848393|OG000|Outcome|Fentanyl (High Dose)|"This arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. First half-dose given at induction and second half-dose given before incision.~Fentanyl (High Dose): Fentanyl (High Dose) 25 mcg/kg in two divided doses. Half-dose will be given at induction and the second half-dose given prior to incision."
10958810|NCT00848393|OG001|Outcome|Fentanyl (Low Dose)|"This arm will receive a total of 10 mcg/kg of Fentanyl (Low Dose). First half-dose will be given at induction and second half -dose given before incision.~Fentanyl (Low Dose): Fentanyl (Low Dose) 10 mcg/kg in two divided doses. Half-dose will be given at induction and the second half-dose given prior to incision."
10958811|NCT00848393|OG002|Outcome|Fentanyl (Low Dose) + Dexmedetomidine|"This arm will receive10 mcg/kg of Fentanyl (Low Dose) -2 divided doses. Dexmedetomidine (Dex) loading dose-1 mcg/kg over 10 min, then Dex infusion at 0.5mcg/kg/hr.~Fentanyl (Low Dose) + Dexmedetomidine: Fentanyl (Low Dose) + Dexmedetomidine. Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision."
10958812|NCT00848393|EG000|Reported Event|Fentanyl (High Dose)|"patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.~Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision."
10958813|NCT00848393|EG001|Reported Event|Fentanyl (Low Dose)|"patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision~Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision."
10958814|NCT00848393|EG002|Reported Event|Fentanyl (Low Dose) + Dexmedetomidine|"patients in this group will receive a total of 10mcg/kg of fentanyl in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.~Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr.in addition this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision."
10958815|NCT00848484|BG000|Baseline|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
10958816|NCT00848484|BG001|Baseline|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
10958817|NCT00848484|BG002|Baseline|Total|Total of all reporting groups
10958818|NCT00848484|FG000|Participant Flow|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
10958819|NCT00848484|FG001|Participant Flow|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
11179269|NCT02055638|BG001|Baseline|Placebo|"Placebo capsules to match the amount of SRX246 capsules for 8 weeks~Placebo"
11179270|NCT02055638|BG002|Baseline|Total|Total of all reporting groups
11179271|NCT02055638|FG000|Participant Flow|SRX246|"SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks~SRX246: capsules"
11179272|NCT02055638|FG001|Participant Flow|Placebo|"Placebo capsules to match the amount of SRX246 capsules for 8 weeks~Placebo"
11179273|NCT02055638|OG000|Outcome|SRX246|"SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks~SRX246: capsules"
11179274|NCT02055638|OG001|Outcome|Placebo|"Placebo capsules to match the amount of SRX246 capsules for 8 weeks~Placebo"
11179275|NCT02055638|EG000|Reported Event|SRX246|"SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks~SRX246: capsules"
10958820|NCT00848484|OG000|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
10958821|NCT00848484|OG001|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
10958822|NCT00848484|EG000|Reported Event|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
10958823|NCT00848484|EG001|Reported Event|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
10958824|NCT00848497|BG000|Baseline|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
10958825|NCT00848497|BG001|Baseline|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
10958826|NCT00848497|BG002|Baseline|Total|Total of all reporting groups
10958827|NCT00848497|FG000|Participant Flow|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
11179276|NCT02055638|EG001|Reported Event|Placebo|"Placebo capsules to match the amount of SRX246 capsules for 8 weeks~Placebo"
10958828|NCT00848497|FG001|Participant Flow|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
10958829|NCT00848497|OG000|Outcome|Testim + Viagra|"Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night~SHIM at Baseline = N/A SHIM at 5 months = N/A"
10958830|NCT00848497|OG001|Outcome|Placebo Testim + Viagra|"Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night~SHIM at Baseline = 0 SHIM at 5 months = 0"
10958831|NCT00848497|OG000|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
10958832|NCT00848497|OG001|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
10958833|NCT00848497|EG000|Reported Event|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
10958834|NCT00848497|EG001|Reported Event|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
10958835|NCT00848510|BG000|Baseline|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958836|NCT00848510|BG001|Baseline|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958837|NCT00848510|BG002|Baseline|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958838|NCT00848510|BG003|Baseline|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958839|NCT00848510|BG004|Baseline|Total|Total of all reporting groups
10958840|NCT00848510|FG000|Participant Flow|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 milligram (mg) at Weeks 1, 3 and 5. In case of clinical benefit (stable disease [SD], complete response [CR], or partial response [PR]) as assessed by the Response Evaluation Criteria in Solid Tumors version (RECIST) Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958841|NCT00848510|FG001|Participant Flow|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
11179277|NCT02055781|BG000|Baseline|Pacritinib, Once Daily|Pacritinib 400 mg, once daily
11179278|NCT02055781|BG001|Baseline|Pacritinib, Twice Daily|Pacritinib 200 mg, twice daily
11179279|NCT02055781|BG002|Baseline|Best Available Therapy|BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry.
11179280|NCT02055781|BG003|Baseline|Total|Total of all reporting groups
11179281|NCT02055781|FG000|Participant Flow|Pacritinib, QD|Pacritinib 400 mg QD
11179282|NCT02055781|FG001|Participant Flow|Pacritinib, BID|Pacritinib 200 mg BID
11179283|NCT02055781|FG002|Participant Flow|Best Available Therapy|BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry
10958842|NCT00848510|FG002|Participant Flow|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958843|NCT00848510|FG003|Participant Flow|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958844|NCT00848510|OG000|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958845|NCT00848510|OG001|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958846|NCT00848510|OG002|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958847|NCT00848510|OG003|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958848|NCT00848510|EG000|Reported Event|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958849|NCT00848510|EG001|Reported Event|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958850|NCT00848510|EG002|Reported Event|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958851|NCT00848510|EG003|Reported Event|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
10958852|NCT00848536|BG000|Baseline|TRAVATAN APS|One drop once daily in the evening for 3 months
10958853|NCT00848536|BG001|Baseline|TRAVATAN|One drop once daily in the evening for 3 months
10958854|NCT00848536|BG002|Baseline|Total|Total of all reporting groups
10958855|NCT00848536|FG000|Participant Flow|TRAVATAN APS|One drop once daily in the evening for 3 months
10958856|NCT00848536|FG001|Participant Flow|TRAVATAN|One drop once daily in the evening for 3 months
10958857|NCT00848536|OG000|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
10958858|NCT00848536|OG001|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
10958859|NCT00848536|EG000|Reported Event|TRAVATAN APS|One drop once daily in the evening for 3 months
10958860|NCT00848536|EG001|Reported Event|TRAVATAN|One drop once daily in the evening for 3 months
10958861|NCT00848549|BG000|Baseline|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
10958862|NCT00848549|BG001|Baseline|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
10958863|NCT00848549|BG002|Baseline|Total|Total of all reporting groups
10958864|NCT00848549|FG000|Participant Flow|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
11179284|NCT02055781|OG000|Outcome|Pacritinib, Once Daily|Pacritinib 400 mg, once daily
10958865|NCT00848549|FG001|Participant Flow|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
11179285|NCT02055781|OG001|Outcome|Pacritinib, Twice Daily|Pacritinib 200 mg, twice daily
11179286|NCT02055781|OG002|Outcome|Best Available Therapy|BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry
11179287|NCT02055781|EG000|Reported Event|Pacritinib, Once Daily|Pacritinib 400 mg, once daily
11179288|NCT02055781|EG001|Reported Event|Pacritinib, Twice Daily|Pacritinib 200 mg, twice daily
11179289|NCT02055781|EG002|Reported Event|Best Available Therapy|BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry
11179290|NCT02055820|BG000|Baseline|Venetoclax 200 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179291|NCT02055820|BG001|Baseline|Venetoclax 400 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179292|NCT02055820|BG002|Baseline|Venetoclax 600 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10958866|NCT00848549|OG000|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
10958867|NCT00848549|OG001|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
11179293|NCT02055820|BG003|Baseline|Venetoclax 800 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179294|NCT02055820|BG004|Baseline|Venetoclax 800 mg +R-CHOP Phase II|Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179295|NCT02055820|BG005|Baseline|Venetoclax 200 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179296|NCT02055820|BG006|Baseline|Venetoclax 400 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179297|NCT02055820|BG007|Baseline|Venetoclax 600 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179298|NCT02055820|BG008|Baseline|Venetoclax 800 mg + G-CHOP A|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179299|NCT02055820|BG009|Baseline|Venetoclax 800 mg +G-CHOP B|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179300|NCT02055820|BG010|Baseline|Total|Total of all reporting groups
11179301|NCT02055820|FG000|Participant Flow|Venetoclax 200 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179302|NCT02055820|FG001|Participant Flow|Venetoclax 400 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179303|NCT02055820|FG002|Participant Flow|Venetoclax 600 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10958868|NCT00848549|EG000|Reported Event|Zonisamide (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
10958869|NCT00848549|EG001|Reported Event|Carbamazepine (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
10958870|NCT00848549|EG002|Reported Event|Zonisamide (Base Study 310, NCT00477295)|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10958871|NCT00848549|EG003|Reported Event|Carbamazepine (Base Study 310, NCT00477295)|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
10958872|NCT00848718|BG000|Baseline|MK-2206 45 mg QOD+Carboplatin+Paclitaxel|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958873|NCT00848718|BG001|Baseline|MK-2206 60 mg QOD+Carboplatin+Paclitaxel|Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958874|NCT00848718|BG002|Baseline|MK-2206 90 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958875|NCT00848718|BG003|Baseline|MK-2206 135 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
11179304|NCT02055820|FG003|Participant Flow|Venetoclax 800 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179305|NCT02055820|FG004|Participant Flow|Venetoclax 800 mg +R-CHOP Phase II|Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10958876|NCT00848718|BG004|Baseline|MK-2206 200 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958877|NCT00848718|BG005|Baseline|MK-2206 45 mg QOD+Docetaxel 75 mg/m^2|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958878|NCT00848718|BG006|Baseline|MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958879|NCT00848718|BG007|Baseline|MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958880|NCT00848718|BG008|Baseline|MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958881|NCT00848718|BG009|Baseline|MK-2206 45 mg QOD+Erlotinib 100 mg|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
10958882|NCT00848718|BG010|Baseline|MK-2206 45 mg QOD+Erlotinib 150 mg|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
10958883|NCT00848718|BG011|Baseline|MK-2206 135 mg QW+Erlotinib 100 mg|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
10958884|NCT00848718|BG012|Baseline|MK-2206 135 mg QW+Erlotinib 150 mg|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
10958885|NCT00848718|BG013|Baseline|Total|Total of all reporting groups
10958886|NCT00848718|FG000|Participant Flow|MK-2206 45 mg QOD+Carboplatin+Paclitaxel|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
11179306|NCT02055820|FG005|Participant Flow|Venetoclax 200 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10958887|NCT00848718|FG001|Participant Flow|MK-2206 60 mg QOD+Carboplatin+Paclitaxel|Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958888|NCT00848718|FG002|Participant Flow|MK-2206 90 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958889|NCT00848718|FG003|Participant Flow|MK-2206 135 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958890|NCT00848718|FG004|Participant Flow|MK-2206 200 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958891|NCT00848718|FG005|Participant Flow|MK-2206 45 mg QOD+Docetaxel 75 mg/m^2|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958892|NCT00848718|FG006|Participant Flow|MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958893|NCT00848718|FG007|Participant Flow|MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958894|NCT00848718|FG008|Participant Flow|MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958895|NCT00848718|FG009|Participant Flow|MK-2206 45 mg QOD+Erlotinib 100 mg|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
10958896|NCT00848718|FG010|Participant Flow|MK-2206 45 mg QOD+Erlotinib 150 mg|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
10958897|NCT00848718|FG011|Participant Flow|MK-2206 135 mg QW+Erlotinib 100 mg|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
10958898|NCT00848718|FG012|Participant Flow|MK-2206 135 mg QW+Erlotinib 150 mg|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
10958899|NCT00848718|OG000|Outcome|MK-2206 45 mg QOD+Carboplatin+Paclitaxel|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958900|NCT00848718|OG001|Outcome|MK-2206 60 mg QOD+Carboplatin+Paclitaxel|Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958901|NCT00848718|OG002|Outcome|MK-2206 90 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958902|NCT00848718|OG003|Outcome|MK-2206 135 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958903|NCT00848718|OG004|Outcome|MK-2206 200 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958904|NCT00848718|OG005|Outcome|MK-2206 45 mg QOD+Docetaxel 75 mg/m^2|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958905|NCT00848718|OG006|Outcome|MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958906|NCT00848718|OG007|Outcome|MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958907|NCT00848718|OG008|Outcome|MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2|Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958908|NCT00848718|OG009|Outcome|MK-2206 45 mg QOD+Erlotinib 100 mg|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
10958909|NCT00848718|OG010|Outcome|MK-2206 45 mg QOD+Erlotinib 150 mg|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
10958910|NCT00848718|OG011|Outcome|MK-2206 135 mg QW+Erlotinib 100 mg|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
10958911|NCT00848718|OG012|Outcome|MK-2206 135 mg QW+Erlotinib 150 mg|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
10958912|NCT00848718|OG000|Outcome|MK-2206 Administered QOD+Carboplatin+Paclitaxel|Participants received MK-2206 45 mg or 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958913|NCT00848718|OG000|Outcome|MK-2206 Administered Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 90 mg, 135 mg, or 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958914|NCT00848718|OG000|Outcome|MK-2206 Administered QOD+Docetaxel|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958915|NCT00848718|OG000|Outcome|MK-2206 Administered Q3W+Docetaxel|Participants received MK-2206 90 mg, 135 mg or 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958916|NCT00848718|OG000|Outcome|MK-2206 Administered QOD+Erlotinib|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg or 150 mg administered PO once every day of each 21-day cycle.
10958917|NCT00848718|OG000|Outcome|MK-2206 Administered QW+Erlotinib|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg or 150 mg administered PO once every day of each 21-day cycle.
10958918|NCT00848718|EG000|Reported Event|MK-2206 45 mg QOD+Carboplatin+Paclitaxel|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958919|NCT00848718|EG001|Reported Event|MK-2206 60 mg QOD+Carboplatin+Paclitaxel|Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958920|NCT00848718|EG002|Reported Event|MK-2206 90 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958921|NCT00848718|EG003|Reported Event|MK-2206 135 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
10958922|NCT00848718|EG004|Reported Event|MK-2206 200 mg Q3W+Carboplatin+Paclitaxel|Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
11179307|NCT02055820|FG006|Participant Flow|Venetoclax 400 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179308|NCT02055820|FG007|Participant Flow|Venetoclax 600 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179309|NCT02055820|FG008|Participant Flow|Venetoclax 800 mg + G-CHOP A|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10958923|NCT00848718|EG005|Reported Event|MK-2206 45 mg QOD+Docetaxel 75 mg/m2|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958924|NCT00848718|EG006|Reported Event|MK-2206 90 mg Q3W+Docetaxel 60 mg/m2|Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958925|NCT00848718|EG007|Reported Event|MK-2206 135 mg Q3W+Docetaxel 60 mg/m2|Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958926|NCT00848718|EG008|Reported Event|MK-2206 200 mg Q3W+Docetaxel 60 mg/m2|Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
10958927|NCT00848718|EG009|Reported Event|MK-2206 45 mg QOD+Erlotinib 100 mg|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
10958928|NCT00848718|EG010|Reported Event|MK-2206 45 mg QOD+Erlotinib 150 mg|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
10958929|NCT00848718|EG011|Reported Event|MK-2206 135 mg QW+Erlotinib 100 mg|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
10958930|NCT00848718|EG012|Reported Event|MK-2206 135 mg QW+Erlotinib 150 mg|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
10958931|NCT00848744|BG000|Baseline|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
10958932|NCT00848744|FG000|Participant Flow|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
10958933|NCT00848744|OG000|Outcome|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
11179310|NCT02055820|FG009|Participant Flow|Venetoclax 800 mg +G-CHOP B|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10958934|NCT00848744|OG001|Outcome|Formulation B|Participants used salicylic acid Formulation A on either the right or left side of the face.
10958935|NCT00848744|EG000|Reported Event|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
10958936|NCT00848783|BG000|Baseline|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
10958937|NCT00848783|BG001|Baseline|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
10958938|NCT00848783|BG002|Baseline|Induction Treatment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
10958939|NCT00848783|BG003|Baseline|Total|Total of all reporting groups
10958940|NCT00848783|FG000|Participant Flow|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
10958941|NCT00848783|FG001|Participant Flow|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
10958942|NCT00848783|FG002|Participant Flow|Induction Treartment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
10958943|NCT00848783|OG000|Outcome|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
10958944|NCT00848783|OG001|Outcome|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
10958945|NCT00848783|OG002|Outcome|Induction Treatment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
10958946|NCT00848783|EG000|Reported Event|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
10958947|NCT00848783|EG001|Reported Event|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
10958948|NCT00848926|BG000|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
10958949|NCT00848926|FG000|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
10958950|NCT00848926|OG000|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
10958951|NCT00848926|EG000|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
10958952|NCT00848965|BG000|Baseline|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
10958953|NCT00848965|FG000|Participant Flow|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
10958954|NCT00848965|OG000|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958955|NCT00848965|OG001|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958956|NCT00848965|OG002|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958957|NCT00848965|OG003|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958958|NCT00848965|OG004|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958959|NCT00848965|EG000|Reported Event|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958960|NCT00848965|EG001|Reported Event|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958961|NCT00848965|EG002|Reported Event|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958962|NCT00848965|EG003|Reported Event|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958963|NCT00848965|EG004|Reported Event|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
10958964|NCT00849017|BG000|Baseline|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958965|NCT00849017|BG001|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
11179311|NCT02055820|OG000|Outcome|Venetoclax 200 mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179312|NCT02055820|OG001|Outcome|Venetoclax 400 mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179313|NCT02055820|OG002|Outcome|Venetoclax 600 mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10958966|NCT00849017|BG002|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958967|NCT00849017|BG003|Baseline|Total|Total of all reporting groups
10958968|NCT00849017|FG000|Participant Flow|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958969|NCT00849017|FG001|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958970|NCT00849017|FG002|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958971|NCT00849017|OG000|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958972|NCT00849017|OG001|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958973|NCT00849017|OG002|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958974|NCT00849017|OG001|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958975|NCT00849017|OG002|Outcome|Albiglutide 50 mg Weekly|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958976|NCT00849017|OG000|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958977|NCT00849017|OG001|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
11179314|NCT02055820|OG003|Outcome|Venetoclax 800mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179315|NCT02055820|OG004|Outcome|Venetoclax 200mg + G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179316|NCT02055820|OG005|Outcome|Venetoclax 400mg + G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10958978|NCT00849017|EG000|Reported Event|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958979|NCT00849017|EG001|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958980|NCT00849017|EG002|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
10958981|NCT00849056|BG000|Baseline|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
10958982|NCT00849056|BG001|Baseline|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
10958983|NCT00849056|BG002|Baseline|Total|Total of all reporting groups
10958984|NCT00849056|FG000|Participant Flow|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
10958985|NCT00849056|FG001|Participant Flow|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
10958986|NCT00849056|OG000|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
10958987|NCT00849056|OG001|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
10958988|NCT00849056|EG000|Reported Event|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
10958989|NCT00849056|EG001|Reported Event|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
10958990|NCT00849108|BG000|Baseline|Cohort 1 Dose Ranging and Dose Interval|Patients received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
10958991|NCT00849108|BG001|Baseline|Cohort 2: Pharm Stress|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at pharmacologic stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose.
10958992|NCT00849108|BG002|Baseline|Cohort 2: Efficacy Exercise Stress|"Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at exercise stress over a 1-day period.~For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose."
10958993|NCT00849108|BG003|Baseline|Total|Total of all reporting groups
10958994|NCT00849108|FG000|Participant Flow|Cohort 1 Dose Ranging and Dose Interval|Patients received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
10958995|NCT00849108|FG001|Participant Flow|Cohort 2 Preliminary Efficacy Pharmacologic Stress|Patients received 2 injections of BMS747158: 1 at rest and 1 at Pharmacologic stress, over a 1-day period.
10958996|NCT00849108|OG000|Outcome|Cohort 1: Dose Acquistion Time Product|Subjects received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
10958997|NCT00849108|OG000|Outcome|Cohort 2 Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
10958998|NCT00849108|OG000|Outcome|Cohort 1 Dose Ranging and Dose Interval|Subjects received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
10958999|NCT00849108|OG000|Outcome|Cohort 2: Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
10959000|NCT00849108|EG000|Reported Event|Cohort 1: Dose Range and Dose Interval|"Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period.~BMS747158: dosages at rest and at stress were not to exceed a total of 14 mCi.~Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period."
10959001|NCT00849108|EG001|Reported Event|Cohort 2: Efficacy in Pharm Stress|"Patients receive 2 IV injections of BMS747158:at rest and stress~For the Pharmacologic (Adenosine) Stress:~Doses range at rest between 2.9 and 3.4 mCi.~Dose range at stress between 5.8 and 8.2 mCi (factor of 2.0 to 2.4 greater than the rest dose).~For the Exercise Stress:~Doses at rest were to range between 1.7 and 2.0 mCi.~Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi."
10959002|NCT00849121|BG000|Baseline|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
10959003|NCT00849121|BG001|Baseline|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
10959004|NCT00849121|BG002|Baseline|Total|Total of all reporting groups
10959005|NCT00849121|FG000|Participant Flow|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally (i.d.) biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally every 3 months until radiographic disease progression"
10959006|NCT00849121|FG001|Participant Flow|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
10959007|NCT00849121|OG000|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
10959008|NCT00849121|OG001|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
10959009|NCT00849121|EG000|Reported Event|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
10959010|NCT00849121|EG001|Reported Event|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
10959011|NCT00849147|BG000|Baseline|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
10959012|NCT00849147|FG000|Participant Flow|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
10959013|NCT00849147|OG000|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
10959014|NCT00849147|EG000|Reported Event|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
10959015|NCT00849186|BG000|Baseline|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
10959016|NCT00849186|FG000|Participant Flow|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
10959017|NCT00849186|OG000|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
10959018|NCT00849186|OG000|Outcome|Sunitinib|"sunitinib malate: oral~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
10959019|NCT00849186|EG000|Reported Event|Sunitinib|"sunitinib malate: oral~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
10959020|NCT00849212|BG000|Baseline|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
10959021|NCT00849212|FG000|Participant Flow|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
10959022|NCT00849212|OG000|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
10959023|NCT00849212|EG000|Reported Event|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
10959024|NCT00849251|BG000|Baseline|Treatment (Chemotherapy and Enzyme Inhibitor)|"Patients receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
10959025|NCT00849251|FG000|Participant Flow|Relapsed Disease (Cohort I)|"Patients with relapsed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
10959026|NCT00849251|FG001|Participant Flow|Newly Diagnosed Disease (Cohort II)|"Patients with newly diagnosed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
10959027|NCT00849251|OG000|Outcome|Relapsed Disease|"Patients with relapsed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
10959028|NCT00849251|OG000|Outcome|Newly Diagnosed Patients|"Patients with newly diagnosed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
10959029|NCT00849251|OG000|Outcome|Relapsed Disease (Cohort I)|"Patients with relapsed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
10959030|NCT00849251|EG000|Reported Event|Treatment (Chemotherapy and Enzyme Inhibitor)|"Patients receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
10959031|NCT00849290|BG000|Baseline|APC8015F|
10959032|NCT00849290|FG000|Participant Flow|APC8015F|APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.
10959033|NCT00849290|OG000|Outcome|APC8015F|
10959034|NCT00849290|EG000|Reported Event|APC8015F|
10959035|NCT00849381|BG000|Baseline|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
10959036|NCT00849381|FG000|Participant Flow|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
10959037|NCT00849381|OG000|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
10959038|NCT00849381|EG000|Reported Event|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
10959039|NCT00849472|BG000|Baseline|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
10959040|NCT00849472|FG000|Participant Flow|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants (par.) were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
10959041|NCT00849472|OG000|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
10959042|NCT00849472|OG000|Outcome|Overall Study Arm|
10959043|NCT00849472|EG000|Reported Event|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
10959044|NCT00849680|BG000|Baseline|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
10959045|NCT00849680|BG001|Baseline|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
10959046|NCT00849680|BG002|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
10959047|NCT00849680|BG003|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
10959048|NCT00849680|BG004|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
10959049|NCT00849680|BG005|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
10959050|NCT00849680|BG006|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
10959051|NCT00849680|BG007|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
10959052|NCT00849680|BG008|Baseline|Total|Total of all reporting groups
10959053|NCT00849680|FG000|Participant Flow|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
10959054|NCT00849680|FG001|Participant Flow|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
10959055|NCT00849680|FG002|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
10959056|NCT00849680|FG003|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
10959057|NCT00849680|FG004|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
10959058|NCT00849680|FG005|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
10959059|NCT00849680|FG006|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
10959060|NCT00849680|FG007|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
10959061|NCT00849680|OG000|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
10959062|NCT00849680|OG001|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
10959063|NCT00849680|OG002|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
10959064|NCT00849680|OG003|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
10959065|NCT00849680|OG004|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
10959066|NCT00849680|OG005|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
10959067|NCT00849680|OG006|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
10959068|NCT00849680|OG007|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
11179317|NCT02055820|OG006|Outcome|Venetoclax 600mg + G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179318|NCT02055820|OG007|Outcome|Venetoclax 800 mg + G-CHOP A|Venetoclax + G-CHOP 800 mg A Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm venetoclax was delivered in Cycle 1 on Days 4-10 and Cycles 2-8 on Days 1-10. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10959069|NCT00849680|EG000|Reported Event|Placebo|
10959070|NCT00849680|EG001|Reported Event|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose)|
11179319|NCT02055820|OG008|Outcome|Venetoclax 800 mg + G-CHOP B|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm ventoclax was delivered in Cycle 1 on Days 4-8 and Cycles 2-8 on Days 1-5. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179320|NCT02055820|OG000|Outcome|Venetoclax + R-CHOP 800 mg Phase II|Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179321|NCT02055820|OG000|Outcome|Venetoclax 800mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179322|NCT02055820|OG001|Outcome|Venetoclax 200 mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179323|NCT02055820|OG002|Outcome|Venetoclax 400 mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179324|NCT02055820|OG003|Outcome|Venetoclax 600 mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179325|NCT02055820|OG004|Outcome|Venetoclax + R-CHOP 800 mg|Phase I and II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179326|NCT02055820|OG005|Outcome|Venetoclax 200mg + G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179327|NCT02055820|OG006|Outcome|Venetoclax 400mg + G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10959071|NCT00849680|EG002|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose)|
10959072|NCT00849680|EG003|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose)|
10959073|NCT00849680|EG004|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose)|
10959074|NCT00849680|EG005|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose)|
10959075|NCT00849680|EG006|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose)|
10959076|NCT00849680|EG007|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose)|
10959077|NCT00849693|BG000|Baseline|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959078|NCT00849693|BG001|Baseline|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959079|NCT00849693|BG002|Baseline|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
10959080|NCT00849693|BG003|Baseline|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959081|NCT00849693|BG004|Baseline|Total|Total of all reporting groups
10959082|NCT00849693|FG000|Participant Flow|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959083|NCT00849693|FG001|Participant Flow|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959084|NCT00849693|FG002|Participant Flow|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
10959085|NCT00849693|FG003|Participant Flow|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959086|NCT00849693|OG000|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
10959087|NCT00849693|OG001|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
10959088|NCT00849693|OG000|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959089|NCT00849693|OG001|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959090|NCT00849693|OG002|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
10959091|NCT00849693|OG003|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
10959092|NCT00849693|OG000|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
10959093|NCT00849693|OG001|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
10959094|NCT00849693|OG002|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
10959095|NCT00849693|OG001|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
10959096|NCT00849693|OG002|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
10959097|NCT00849693|OG003|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
10959098|NCT00849693|EG000|Reported Event|Duloxetine 60 mg - Acute|Duloxetine 60 mg, orally, once daily for 10 weeks
10959099|NCT00849693|EG001|Reported Event|Duloxetine 30 mg - Acute|Duloxetine 30 mg, orally, once daily for 10 weeks
10959100|NCT00849693|EG002|Reported Event|Fluoxetine 20 mg - Acute|Fluoxetine 20 mg, orally, once daily for 10 weeks
11179328|NCT02055820|OG007|Outcome|Venetoclax 600mg + G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179329|NCT02055820|OG008|Outcome|Venetoclax + G-CHOP 800mg|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179330|NCT02055820|OG000|Outcome|Venetoclax + R-CHOP 100 mg|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179331|NCT02055820|OG004|Outcome|Venetoclax 800mg + R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179332|NCT02055820|OG008|Outcome|Venetoclax + G-CHOP 800 mg|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179333|NCT02055820|OG000|Outcome|Venetoclax PK Popluation|"All participants in the study.~Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor."
11179334|NCT02055820|OG000|Outcome|Venetoclax 800 mg|"All participants in the study, who received 800 mg venetoclax.~Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor."
11179335|NCT02055820|OG004|Outcome|Venetoclax + R-CHOP 800 mg Phase II|Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
10959101|NCT00849693|EG003|Reported Event|Placebo - Acute|Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks
10959102|NCT00849693|EG004|Reported Event|Duloxetine 60 mg - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
10959103|NCT00849693|EG005|Reported Event|Duloxetine 30 mg - Extension|"Duloxetine 60-120 mg , orally, once daily for 6 months~One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase [see Participant Flow section])."
10959104|NCT00849693|EG006|Reported Event|Fluoxetine 20 mg - Extension|Fluoxetine 20-40 mg, orally, once daily for 6 months
10959105|NCT00849693|EG007|Reported Event|Placebo/Duloxetine - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
10959106|NCT00849810|BG000|Baseline|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
10959107|NCT00849810|FG000|Participant Flow|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
10959108|NCT00849810|OG000|Outcome|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
10959109|NCT00849810|EG000|Reported Event|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
10959110|NCT00849875|BG000|Baseline|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959111|NCT00849875|BG001|Baseline|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959112|NCT00849875|BG002|Baseline|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959113|NCT00849875|BG003|Baseline|Total|Total of all reporting groups
10959114|NCT00849875|FG000|Participant Flow|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
10959115|NCT00849875|OG000|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
10959116|NCT00849875|OG001|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959117|NCT00849875|OG002|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959118|NCT00849875|OG003|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959119|NCT00849875|OG003|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening
10959120|NCT00849875|OG000|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959121|NCT00849875|OG001|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959122|NCT00849875|OG002|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
10959123|NCT00849875|EG000|Reported Event|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
10959124|NCT00849901|BG000|Baseline|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
10959125|NCT00849901|BG001|Baseline|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
10959126|NCT00849901|BG002|Baseline|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
10959127|NCT00849901|BG003|Baseline|Total|Total of all reporting groups
10959128|NCT00849901|FG000|Participant Flow|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
10959129|NCT00849901|FG001|Participant Flow|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
10959130|NCT00849901|FG002|Participant Flow|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
10959131|NCT00849901|OG000|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
10959132|NCT00849901|OG001|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
10959133|NCT00849901|OG002|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
10959134|NCT00849901|OG000|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
10959135|NCT00849901|OG001|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
10959136|NCT00849901|OG002|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
10959137|NCT00849901|EG000|Reported Event|Duloxetine - Acute|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
10959138|NCT00849901|EG001|Reported Event|Fluoxetine - Acute|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
10959139|NCT00849901|EG002|Reported Event|Placebo - Acute|Received placebo PO, QD during acute treatment phase
10959140|NCT00849901|EG003|Reported Event|Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
10959141|NCT00849901|EG004|Reported Event|Fluoxetine - Extension|Received fluoxetine 20 and/or 40 mg PO, QD during extension phase. One participant had discontinued the acute phase due to an adverse event but was accidentally dispensed drug at the last visit of the acute phase, thus based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs) (resulting in one more participant being analyzed for AEs than started the extension phase in the Participant Flow section).
10959142|NCT00849901|EG005|Reported Event|Placebo/Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
10963832|NCT00874510|BG001|Baseline|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
10963833|NCT00874510|BG002|Baseline|Total|Total of all reporting groups
10963834|NCT00874510|FG000|Participant Flow|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
10963835|NCT00874510|FG001|Participant Flow|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
10963836|NCT00874510|OG000|Outcome|Arm 1 - Standard Schedule for Years 1 and Year 2|interns work standard schedule, being on duty for 30 continuous hours
10963837|NCT00874510|OG001|Outcome|Arm 2 - Mandatory Nap|"In Year 1 interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am and were asked to nap during this time~For Year 2, the mandatory sign out of cell phones and cross-coverage responsibilities was split between two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am and were asked to nap during this time"
10963838|NCT00874510|EG000|Reported Event|Arm 1 - Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
10963839|NCT00874510|EG001|Reported Event|Arm 2 - Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
10963840|NCT00874549|BG000|Baseline|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
10963841|NCT00874549|BG001|Baseline|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
10963842|NCT00874549|BG002|Baseline|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
10963843|NCT00874549|BG003|Baseline|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
10963844|NCT00874549|BG004|Baseline|Total|Total of all reporting groups
10963845|NCT00874549|FG000|Participant Flow|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
10963846|NCT00874549|FG001|Participant Flow|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
11234407|NCT02435069|FG001|Participant Flow|Post-Operative Dose Response: NS Then USP Glycerin|Subjects randomized to treatment sequence. Arm evaluated dose-response relationship and was used to identify the minimum dosing volume and frequency of ACE administration for NS and USP glycerin necessary to meet outcome criteria. NS started at 10mL/kg administered every other day. Dose titrated to achieve continence so as not to exceed 500 mL NS daily for a child under five years of age, 1000 mL NS daily for a child over 5 years of age. Participant continued on effective dose for 2 weeks to insure treatment stability and effectiveness. If the maximum dose did not result in continence, if the dose necessary to minimize side effects resulted in episodes of fecal soiling, or if there were side effects greater than WBFPRS level 4 at the lowest dose of administration, the child was trialed on the alternate therapy and then dropped from the study.
11234408|NCT02435069|FG002|Participant Flow|Post-Operative Dose Response: USP Glycerin Then NS|Subjects randomized to treatment sequence. Arm evaluated dose-response relationship and was used to identify the minimum dosing volume and frequency of ACE administration for USP glycerin and necessary to meet outcome criteria. Glycerin started at 20 mL administered every other day. Dose titrated to achieve continence so as not to exceed 50 mL daily. Participant continued on effective dose for 2 weeks to insure treatment stability and effectiveness. If the maximum dose did not result in continence, if the dose necessary to minimize side effects resulted in episodes of fecal soiling, or if there were side effects greater than WBFPRS level 4 at the lowest dose of administration, the child was trialed on the alternate therapy and then dropped from the study.
11234409|NCT02435069|FG003|Participant Flow|Effectiveness Phase: NS Then USP Glycerin|To prevent statistical bias from subject loss due to treatment failure, each child who successfully completed the dosing phase was randomized to a second treatment sequence once they have achieved continence on optimal dosing with minimal side effects. This arm evaluated the long term effectiveness of NS at optimal dose and administration frequency for 4 weeks and served as comparison between flush solutions. The study concluded with the child being placed back on 2 weeks of the initial flush in the randomized sequence.
11234410|NCT02435069|FG004|Participant Flow|Effectiveness Phase: USP Glycerin Then NS|To prevent statistical bias from subject loss due to treatment failure, each child who successfully completed the dosing phase was randomized to a second treatment sequence once they have achieved continence on optimal dosing with minimal side effects. This arm evaluated the long term effectiveness of USP glycerin at optimal dose and administration frequency for 4 weeks and served as comparison between flush solutions. The study concluded with the child being placed back on 2 weeks of the initial flush in the randomized sequence.
11234411|NCT02435069|OG000|Outcome|Subjects Continent on NS Antegrade Flush|Number of participants that gained and maintained continence on antegrade enema.
11234412|NCT02435069|OG001|Outcome|Subjects Continent on USP Glycerin|Number of participants that gained and maintained continence on USP Glycerin antegrade enema.
11234413|NCT02435069|OG000|Outcome|Episodes of Fecal Incontinence on NS Antegrade Flush|Number of episodes of fecal soiling that occurred daily on NS flushing regimen
11234414|NCT02435069|OG001|Outcome|Episodes of Fecal Incontinence on USP Glycerin Antegrade Flush|Number of episodes of fecal soiling that occurred daily on a USP Glycerin flushing regimen
11234415|NCT02435069|OG000|Outcome|Dosing Frequency on NS|The minimum frequency with which the NS antegrade flush was administered during the dosing phase of the study necessary to gain and maintain continence. Data includes the maximum frequency of administration trialed in subjects who failed to gain continence on NS antegrade flush.
11234416|NCT02435069|OG001|Outcome|Dosing Frequency on USP Glycerin|The minimum frequency with which the USP Glycerin antegrade flush was administered during the dosing phase of the study necessary to gain and maintain continence. Data includes the maximum frequency of administration trialed in subjects who failed to gain continence on USP GLycerin antegrade flush.
11234417|NCT02435069|OG000|Outcome|Flush Volume of NS|Volume of flush solution administered during the last NS flush completed in the dosing phase of the study. Data from subjects who failed to gain and maintain continence during the dosing phase of the study on the maximum saline flush volume (500mL for subjects under 5 years of age and 1,000 mL for subjects over 5 years of age) are not included in the data. Data includes one subject who gained and maintained continence on saline in both the dosing and maintenance phases of the study, and one subject who gained continence during the dosing phase of the study but failed to maintain continence on saline during the maintenance phase of the study.
11234418|NCT02435069|OG001|Outcome|Flush Volume of USP Glycerin|Volume of flush solution administered during the last USP Glycerin flush completed in the dosing phase of the study. Data from subjects who failed to gain and maintain continence on the maximum USP Glycerin flush volume (50mL) are not included in the data.
11234419|NCT02435069|OG000|Outcome|Elelctrolye Abnormalities on NS FLush|Number of participants who had abnormalities in Basic Metabolic Panel on NS antegrade flush
11234420|NCT02435069|OG001|Outcome|Elelctrolye Abnormalities on USP Glycerin FLush|Number of participants who had abnormalities in Basic Metabolic Panel on USP Glycerin antegrade flush
11234421|NCT02435069|OG000|Outcome|Calprotectin Levels Following NS FLush|Calprotectin level from stool sample obtained at completion of the NS dosing phase compared to baseline.
11234422|NCT02435069|OG001|Outcome|Calprotectin Levels Following USP Glycerin FLush|Calprotectin level from stool sample obtained at completion of the USP Glycerin dosing phase compared to baseline.
11234423|NCT02435069|OG000|Outcome|Pain With NS Antegrade Flush Administration|Abdominal pain or cramping associated with NS flush as measured by the WBFPRS
11234424|NCT02435069|OG001|Outcome|Pain With USP Glycerin Antegrade Flush Administration|Abdominal pain or cramping associated with USP Glycerin flush as measured by the WBFPRS
11234425|NCT02435069|OG000|Outcome|Vagal Symptoms With NS FLush|Number of subjects experiencing vagal symptoms with antegrade administration of NS flush solution
10959143|NCT00849940|BG000|Baseline|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
11234426|NCT02435069|OG001|Outcome|Vagal Symptoms With USP Glycerin Flush|Number of subjects experiencing vagal symptoms with antegrade administration of USP GLycerin flush solution
11234427|NCT02435069|EG000|Reported Event|Vagal Symptoms With NS Flush|Number of subjects experiencing vasovagal symptoms (symptom complex including pallor, diaphoresis, dizziness, weakness, nausea, with or without syncope) with antegrade administration of NS flush solution
11179336|NCT02055820|OG008|Outcome|Venetoclax 800 mg + G-CHOP A|Venetoclax + G-CHOP 800 mg A Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm venetoclax was delivered in Cycle 1 on Days 4-10 and Cycles 2-8 on Days 1-10. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179337|NCT02055820|OG009|Outcome|Venetoclax 800 mg + G-CHOP B|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm ventoclax was delivered in Cycle 1 on Days 4-8 and Cycles 2-8 on Days 1-5. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179338|NCT02055820|OG000|Outcome|Venetoclax + R-CHOP Arm|"Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days.~Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days.~Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor."
11179339|NCT02055820|OG001|Outcome|Venetoclax 600mg + G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179340|NCT02055820|OG009|Outcome|Venetoclax + G-CHOP 800mg B|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days.
11179341|NCT02055820|EG000|Reported Event|Venetoclax 200 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179342|NCT02055820|EG001|Reported Event|Venetoclax 400 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179343|NCT02055820|EG002|Reported Event|Venetoclax 600 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179344|NCT02055820|EG003|Reported Event|Venetoclax 800 mg +R-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179345|NCT02055820|EG004|Reported Event|Venetoclax 800 mg +R-CHOP Phase II|Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179346|NCT02055820|EG005|Reported Event|Venetoclax 200 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179347|NCT02055820|EG006|Reported Event|Venetoclax 400 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179348|NCT02055820|EG007|Reported Event|Venetoclax 600 mg +G-CHOP|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179349|NCT02055820|EG008|Reported Event|Venetoclax 800 mg + G-CHOP A|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179350|NCT02055820|EG009|Reported Event|Venetoclax 800 mg +G-CHOP B|Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
11179351|NCT02055898|BG000|Baseline|Placebo First Then Sodium Oxybate|7 Patients who meet criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian diagnostic systems.
11179352|NCT02055898|BG001|Baseline|Sodium Oxybate First Then Placebo|6 Patients who meet criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian diagnostic systems.
11179353|NCT02055898|BG002|Baseline|Total|Total of all reporting groups
11179354|NCT02055898|FG000|Participant Flow|Placebo Then Sodium Oxybate|7 patients with chronic fatigue syndrome
11179355|NCT02055898|FG001|Participant Flow|Sodium Oxybate Then Placebo|6 patients with chronic fatigue syndrome
11179356|NCT02055898|OG000|Outcome|Sodium Oxybate|All participants who completed the study and whose recordings were adequate, during the sodium oxybate period
11179357|NCT02055898|OG001|Outcome|Placebo|All participants who completed the study, and whose recordings were adequate, during the placebo period
11179358|NCT02055898|EG000|Reported Event|Placebo|All participants who received at least one dose of placebo
11179359|NCT02055898|EG001|Reported Event|Sodium Oxybate|All participants who received at least one dose of sodium oxybate
10959144|NCT00849940|FG000|Participant Flow|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
10959145|NCT00849940|OG000|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
10959146|NCT00849940|EG000|Reported Event|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
10959147|NCT00850031|BG000|Baseline|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: Inlay implanted in cornea for improvement of near vision"
10959148|NCT00850031|FG000|Participant Flow|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
10959149|NCT00850031|OG000|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
10959150|NCT00850031|EG000|Reported Event|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
10959151|NCT00850070|BG000|Baseline|Sapropterin|tetrahydrobiopterin (BH4)
10959152|NCT00850070|BG001|Baseline|Placebo|sugar pill
10959153|NCT00850070|BG002|Baseline|Total|Total of all reporting groups
10959154|NCT00850070|FG000|Participant Flow|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
10959155|NCT00850070|FG001|Participant Flow|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
10959156|NCT00850070|OG000|Outcome|Sapropterin|sapropterin 20 mg/kg/day
10959157|NCT00850070|OG001|Outcome|Placebo|sugar pill
10959158|NCT00850070|OG000|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
10959159|NCT00850070|OG000|Outcome|Sapropterin, 100 mg Capsules|"Sapropterin was supplied as a 100 mg tablet and dosage was based on 20 mg/kg/d, rounding to the nearest 100 mg. Most subjects crushed the tablets and administered it in liquid or a food to mask the taste. Subjects took the same dose daily for 16 weeks.~sapropterin: Patients will receive sapropterin 20 mg per kilogram per day for 16 weeks"
10959160|NCT00850070|OG001|Outcome|Placebo, Matching Active Drug|"The placebo was supplied as a 100 mg tablet, and dosage was based on 20 mg/kg/d, rounding to the nearest 100 mg. Most subjects crushed the tablets and administered it in liquid or a food to mask the taste. Subjects took the same dose daily for 16 weeks.~Placebo: Patients will receive a placebo identical in form and dosage to the active drug daily for 16 weeks."
10959161|NCT00850070|OG000|Outcome|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
10959162|NCT00850070|OG001|Outcome|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
10959163|NCT00850070|EG000|Reported Event|Sapropterin|sapropterin 20 mg/kg/day
10959164|NCT00850070|EG001|Reported Event|Placebo|sugar pill
10959165|NCT00850096|BG000|Baseline|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
10959166|NCT00850096|BG001|Baseline|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
10959167|NCT00850096|BG002|Baseline|Total|Total of all reporting groups
10959168|NCT00850096|FG000|Participant Flow|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
10959169|NCT00850096|FG001|Participant Flow|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
10959170|NCT00850096|OG000|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
10959171|NCT00850096|OG001|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
10959172|NCT00850096|EG000|Reported Event|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
10959173|NCT00850096|EG001|Reported Event|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
10959174|NCT00850135|BG000|Baseline|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
10959175|NCT00850135|FG000|Participant Flow|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
10959176|NCT00850135|OG000|Outcome|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
10959177|NCT00850135|OG000|Outcome|Participants With AUC 130 <= 22,000|"AUC-130 values were divided intohigh and low at a cutoff of 22,000, which was the 90th percentile of AUC-130 values."
10959178|NCT00850135|OG001|Outcome|Participants With AUC 130 >22,000|"AUC-130 values were divided intohigh and low at a cutoff of 22,000, which was the 90th percentile of AUC-130 values."
10959179|NCT00850135|EG000|Reported Event|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
10959180|NCT00850200|BG000|Baseline|Proton Therapy Plan Compared to IMRT and Conventional RT|Each patient has a proton, IMRT and conventional plan done prior to treatment for dosimetric comparison of the primary endpoint which is the percent of the body that receives 4 Gray (%V4). The plan that delivers the smallest %V4 will be the plan that is pursued for actual treatment. Therefore, each patient will have three treatment plans, but will only be treated with one of these three plans (the superior one).
10959181|NCT00850200|FG000|Participant Flow|Optimal Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).~The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
10959182|NCT00850200|OG000|Outcome|Proton Radiation Plan|Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
11179360|NCT02055976|BG000|Baseline|Atorvastatin + PF-04950615 50 mg|Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179361|NCT02055976|BG001|Baseline|Atorvastatin + PF-04950615 100 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179362|NCT02055976|BG002|Baseline|Atorvastatin + PF-04950615 150 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
10959183|NCT00850200|OG001|Outcome|Conventional Photon Radiation Plan|Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
10959184|NCT00850200|OG002|Outcome|Intensity Modulated Radiation Plan|Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
10959185|NCT00850200|OG000|Outcome|Treated Cohort|Overall survival as estimated with the Kaplan-Meier product limit method at 4 years after treatment.
10959186|NCT00850200|EG000|Reported Event|Superior Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).~The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
11179363|NCT02055976|BG003|Baseline|Atorvastatin + PF-04950615 Placebo|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
10959187|NCT00850343|BG000|Baseline|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959188|NCT00850343|BG001|Baseline|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10963847|NCT00874549|FG002|Participant Flow|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
11179364|NCT02055976|BG004|Baseline|Atorvastatin + Ezetimibe 10 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
11179365|NCT02055976|BG005|Baseline|PF-04950615 50 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179366|NCT02055976|BG006|Baseline|PF-04950615 100 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179367|NCT02055976|BG007|Baseline|PF-04950615 150 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179368|NCT02055976|BG008|Baseline|PF-04950615 Placebo|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179369|NCT02055976|BG009|Baseline|Total|Total of all reporting groups
11179370|NCT02055976|FG000|Participant Flow|Atorvastatin + PF-04950615 50 mg|Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179371|NCT02055976|FG001|Participant Flow|Atorvastatin + PF-04950615 100 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179372|NCT02055976|FG002|Participant Flow|Atorvastatin + PF-04950615 150 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179373|NCT02055976|FG003|Participant Flow|Atorvastatin + PF-04950615 Placebo|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179374|NCT02055976|FG004|Participant Flow|Atorvastatin + Ezetimibe 10 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
11179375|NCT02055976|FG005|Participant Flow|PF-04950615 50 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179376|NCT02055976|FG006|Participant Flow|PF-04950615 100 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179377|NCT02055976|FG007|Participant Flow|PF-04950615 150 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179378|NCT02055976|FG008|Participant Flow|PF-04950615 Placebo|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179379|NCT02055976|OG000|Outcome|Atorvastatin + PF-04950615 50 mg|Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179380|NCT02055976|OG001|Outcome|Atorvastatin + PF-04950615 100 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179381|NCT02055976|OG002|Outcome|Atorvastatin + PF-04950615 150 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179382|NCT02055976|OG003|Outcome|Atorvastatin + PF-04950615 Placebo|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179383|NCT02055976|OG004|Outcome|Atorvastatin + Ezetimibe 10 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
11179384|NCT02055976|OG005|Outcome|PF-04950615 50 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
11179385|NCT02055976|OG006|Outcome|PF-04950615 100 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
11179386|NCT02055976|OG007|Outcome|PF-04950615 150 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
11179387|NCT02055976|OG008|Outcome|PF-04950615 Placebo|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179388|NCT02055976|OG004|Outcome|PF-04950615 50 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
10959189|NCT00850343|BG002|Baseline|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959190|NCT00850343|BG003|Baseline|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
11234428|NCT02435069|EG001|Reported Event|Vagal Symptoms With USP Glycerin Flush|Number of subjects experiencing vasovagal symptoms (symptom complex including pallor, diaphoresis, dizziness, weakness, nausea, with or without syncope) with antegrade administration of USP Glycerin flush solution
11234429|NCT02435147|BG000|Baseline|Denosumab|This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
11234430|NCT02435147|FG000|Participant Flow|Denosumab|This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
11234431|NCT02435147|OG000|Outcome|Denosumab|This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
11234432|NCT02435147|EG000|Reported Event|Denosumab|This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
11234433|NCT02435277|BG000|Baseline|FDC 125|Leucine 1100mg +Metformin 125mg
11234434|NCT02435277|BG001|Baseline|FDC 250|Leucine 1100mg +Metformin 250mg
11234435|NCT02435277|BG002|Baseline|FDC 500|Leucine 1100mg +Metformin 500mg
11234436|NCT02435277|BG003|Baseline|Control|850mg Metformin
11234437|NCT02435277|BG004|Baseline|Total|Total of all reporting groups
10959191|NCT00850343|BG004|Baseline|Total|Total of all reporting groups
11234438|NCT02435277|FG000|Participant Flow|FDC 125|Leucine 1100mg +Metformin 125mg
11234439|NCT02435277|FG001|Participant Flow|FDC 250|Leucine 1100mg +Metformin 250mg
11234440|NCT02435277|FG002|Participant Flow|FDC 500|Leucine 1100mg +Metformin 500mg
11234441|NCT02435277|FG003|Participant Flow|Control|850mg Metformin
11234442|NCT02435277|OG000|Outcome|FDC 125|Leucine 1100mg +Metformin 125mg
11234443|NCT02435277|OG001|Outcome|FDC 250|Leucine 1100mg +Metformin 250mg
11234444|NCT02435277|OG002|Outcome|FDC 500|Leucine 1100mg +Metformin 500mg
11234445|NCT02435277|OG003|Outcome|Control|850mg Metformin
11234446|NCT02435277|EG000|Reported Event|FDC 125|Leucine 1100mg +Metformin 125mg
11234447|NCT02435277|EG001|Reported Event|FDC 250|Leucine 1100mg +Metformin 250mg
10959192|NCT00850343|FG000|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
11234448|NCT02435277|EG002|Reported Event|FDC 500|Leucine 1100mg +Metformin 500mg
11234449|NCT02435277|EG003|Reported Event|Control|850mg Metformin
11234450|NCT02435381|BG000|Baseline|Placebo/Carisbamate|"This within-subjects study included two treatment arms (placebo and carisbamate); 8 subjects completed both study arms.~Participants received placebo on study days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study procedures under the alternate study drug condition (active carisbamate)~Placebo: 0mg orally on days 2-4 Carisbamate: 600mg orally on days 2-4"
11234451|NCT02435381|FG000|Participant Flow|Placebo First, Then Carisbamate|Participants received placebo from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (active carisbamate)
11234452|NCT02435381|FG001|Participant Flow|Carisbamate First, Then Placebo|Participants received carisbamate from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (placebo)
11234453|NCT02435381|OG000|Outcome|Placebo + Alcohol Beverage|"Participants will receive placebo from days 2- 4.~Placebo: Placebo treatment only"
11234454|NCT02435381|OG001|Outcome|Carisbamate + Alcohol Beverage|"Participants will receive carisbamate 600mg qd from days 2- 4.~Carisbamate: 600mg Orally on days 2-4"
11234455|NCT02435381|OG002|Outcome|Placebo + Placebo Beverage|"Participants will receive placebo from days 2- 4.~Placebo: Placebo treatment only"
11234456|NCT02435381|OG003|Outcome|Carisbamate + Placebo Beverage|"Participants will receive carisbamate 600mg qd from days 2- 4.~Carisbamate: 600mg Orally on days 2-4"
11234457|NCT02435381|OG000|Outcome|Placebo + Alcohol Beverage|"Participants will receive placebo from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (active carisbamate)~Placebo: Placebo treatment only"
11234458|NCT02435381|OG001|Outcome|Carisbamate + Alcohol Beverage|"Participants will receive carisbamate 600mg qd from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition ( placebo).~Carisbamate: 600mg Orally on days 2-4"
11234459|NCT02435381|OG000|Outcome|Placebo|"Participants will receive placebo from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (active carisbamate)~Placebo: Placebo treatment only"
11234460|NCT02435381|OG001|Outcome|Carisbamate|"Participants will receive carisbamate 600mg qd from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition ( placebo).~Carisbamate: 600mg Orally on days 2-4"
11234461|NCT02435381|OG000|Outcome|Placebo|"Participants will receive placebo from days 2- 4.~Placebo: Placebo treatment only"
10959193|NCT00850343|FG001|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959194|NCT00850343|FG002|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959195|NCT00850343|FG003|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959196|NCT00850343|OG000|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959197|NCT00850343|OG001|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959198|NCT00850343|OG002|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959199|NCT00850343|OG003|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959200|NCT00850343|EG000|Reported Event|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959201|NCT00850343|EG001|Reported Event|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959202|NCT00850343|EG002|Reported Event|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
11179389|NCT02055976|OG005|Outcome|PF-04950615 100 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
11179390|NCT02055976|OG006|Outcome|PF-04950615 150 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
10959203|NCT00850343|EG003|Reported Event|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959204|NCT00850395|BG000|Baseline|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
10959205|NCT00850395|FG000|Participant Flow|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
10959206|NCT00850395|OG000|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
10959207|NCT00850395|EG000|Reported Event|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
10959208|NCT00850460|BG000|Baseline|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
10959209|NCT00850460|BG001|Baseline|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
10959210|NCT00850460|BG002|Baseline|Total|Total of all reporting groups
10959211|NCT00850460|FG000|Participant Flow|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
10959212|NCT00850460|FG001|Participant Flow|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
10959213|NCT00850460|OG000|Outcome|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
11179391|NCT02055976|OG007|Outcome|PF-04950615 Placebo|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179392|NCT02055976|OG003|Outcome|PF-04950615 50 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
10959214|NCT00850460|OG001|Outcome|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
10959215|NCT00850460|EG000|Reported Event|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
10959216|NCT00850460|EG001|Reported Event|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
10959217|NCT00850473|BG000|Baseline|Positron Emitting Image, F18 FDG, Contrast Dye|Patient will have a PET/CT imaging study to determine cardiac stenosis, patient will have an injection of F18 FDG to determine the metabolic uptake of the radio-isotope, patient will have contrast dye injected to better visualize the coronary arteries.
10959218|NCT00850473|FG000|Participant Flow|Positron Emitting Image, F-18 FDG, Contrast Dye|Patient will have a PET/CT imaging study to determine cardiac stenosis, patient will have an injection of F18 FDG to determine the metabolic uptake of the radio-isotope, patient will have contrast dye injected to better visualize the coronary arteries.
10959219|NCT00850473|OG000|Outcome|Positron Emitting Image|"Patient will have a PET/CT imaging study to determine cardiac stenosis~PET/CT: Patient will have a Positron Emitting Tomography imaging"
10959220|NCT00850473|EG000|Reported Event|Positron Emitting Image, F18 FDG, Contrast Dye|"PET/CT: Patient will have a Positron Emitting Tomography imaging~Patient will have an injection of F-18-FDG to determine the metabolic uptake of the radioisotope~Contrast Dye: Patient will be injected with contrast dye to better visualize the coronary arteries~Heparin/intralipid infusion: Patient will be injected with heparin/intralipid infusion for backgroud myocardial uptake"
10959221|NCT00850499|BG000|Baseline|Velcade + Fludarabine|
10959222|NCT00850499|BG001|Baseline|Rituximab + Fludarabine|
10959223|NCT00850499|BG002|Baseline|Total|Total of all reporting groups
10959224|NCT00850499|FG000|Participant Flow|Velcade + Fludarabine|
10959225|NCT00850499|FG001|Participant Flow|Rituximab + Fludarabine|
10959226|NCT00850499|OG000|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
10959227|NCT00850499|OG001|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
10959228|NCT00850499|EG000|Reported Event|Velcade + Fludarabine|
10959229|NCT00850499|EG001|Reported Event|Rituximab + Fludarabine|
10959230|NCT00850538|BG000|Baseline|Enrolled|"Subjects having primary knee replacement surgery~Exclusion Criteria:~having a revision knee replacement instead of a primary knee replacement~contraindicated for MRI or CT scans~allergy to the contrast agent gadolinium~pregnant women"
11179393|NCT02055976|OG004|Outcome|PF-04950615 100 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
10959231|NCT00850538|FG000|Participant Flow|Enrolled|"Inclusion Criteria:~- subjects having primary knee replacement surgery~Exclusion Criteria:~having a revision knee replacement instead of a primary knee replacement~contraindicated for MRI or CT scans~allergy to the contrast agent gadolinium~pregnant women"
10959232|NCT00850538|OG000|Outcome|Specimens|Viable specimens for genetic analysis
10959233|NCT00850538|EG000|Reported Event|Enrolled|subjects having primary knee replacement surgery
10959234|NCT00850564|BG000|Baseline|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
10959235|NCT00850564|FG000|Participant Flow|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
10959236|NCT00850564|OG000|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
10959237|NCT00850564|EG000|Reported Event|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
10959238|NCT00850603|BG000|Baseline|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
10959239|NCT00850603|BG001|Baseline|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
10959240|NCT00850603|BG002|Baseline|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
10959241|NCT00850603|BG003|Baseline|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
10959242|NCT00850603|BG004|Baseline|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
10959243|NCT00850603|BG005|Baseline|Total|Total of all reporting groups
10959244|NCT00850603|FG000|Participant Flow|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
10959245|NCT00850603|FG001|Participant Flow|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
10959246|NCT00850603|FG002|Participant Flow|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
10959247|NCT00850603|FG003|Participant Flow|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
10959248|NCT00850603|FG004|Participant Flow|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
10959249|NCT00850603|OG000|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
10959250|NCT00850603|OG001|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
10959251|NCT00850603|OG002|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
10959252|NCT00850603|OG003|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
10959253|NCT00850603|OG004|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
10959254|NCT00850603|EG000|Reported Event|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
10959255|NCT00850603|EG001|Reported Event|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
10959256|NCT00850603|EG002|Reported Event|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
10959257|NCT00850603|EG003|Reported Event|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
10959258|NCT00850603|EG004|Reported Event|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
10959259|NCT00850642|BG000|Baseline|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days.
10959260|NCT00850642|BG001|Baseline|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally, once daily for 12-days.
10959261|NCT00850642|BG002|Baseline|Total|Total of all reporting groups
10959262|NCT00850642|FG000|Participant Flow|Placebo|The eligible participants in this arm were administered with matching placebo, orally, once daily for 12-days.
10959263|NCT00850642|FG001|Participant Flow|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 milligram (mg), orally once daily for 12-days.
10959264|NCT00850642|OG000|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
10959265|NCT00850642|OG001|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
10959266|NCT00850642|OG000|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days.
10959267|NCT00850642|OG001|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days.
10959268|NCT00850642|OG000|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, once daily for 12-days.
10959269|NCT00850642|OG001|Outcome|GSK2190915|The eligible participants in this arm received 100 mg GSK2190915, once daily for 12-days.
10959270|NCT00850642|OG000|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
10959271|NCT00850642|EG000|Reported Event|Placebo|The eligible participants in this arm were administered with matching placebo, orally, once daily for 12-days.
10959272|NCT00850642|EG001|Reported Event|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days.
10959273|NCT00850759|BG000|Baseline|Virtual Reality|street-crossing training in a virtual pedestrian environment
10959274|NCT00850759|BG001|Baseline|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
10959275|NCT00850759|BG002|Baseline|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
10959276|NCT00850759|BG003|Baseline|No-contact Control|no-contact control group.
10959277|NCT00850759|BG004|Baseline|Total|Total of all reporting groups
10959278|NCT00850759|FG000|Participant Flow|Virtual Reality|street-crossing training in a virtual pedestrian environment
10959279|NCT00850759|FG001|Participant Flow|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
10959280|NCT00850759|FG002|Participant Flow|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
10959281|NCT00850759|FG003|Participant Flow|No-contact Control|no-contact control group.
10959282|NCT00850759|OG000|Outcome|Virtual Reality|street-crossing training in a virtual pedestrian environment
10959283|NCT00850759|OG001|Outcome|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
10959284|NCT00850759|OG002|Outcome|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
10959285|NCT00850759|OG003|Outcome|No-contact Control|no-contact control group.
10959286|NCT00850759|EG000|Reported Event|Virtual Reality|street-crossing training in a virtual pedestrian environment
10959287|NCT00850759|EG001|Reported Event|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
10959288|NCT00850759|EG002|Reported Event|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
10959289|NCT00850759|EG003|Reported Event|No-contact Control|no-contact control group.
10959290|NCT00850889|BG000|Baseline|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
10959291|NCT00850889|FG000|Participant Flow|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
10959292|NCT00850889|OG000|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
10959293|NCT00850889|OG001|Outcome|Restylane(R) Injectable Gel|
10959294|NCT00850889|OG000|Outcome|Total Study Participants|
10959295|NCT00850889|EG000|Reported Event|Juvederm Ultra Injectable Gel With Lidocaine|
10959296|NCT00850889|EG001|Reported Event|Restylane|
10959297|NCT00850993|BG000|Baseline|Cohort 1: Stannsoporfin 1.5 mg/kg|1.5 mg/kg stannsoporfin (with phototherapy as needed)
10959298|NCT00850993|BG001|Baseline|Cohort 2: Stannsoporfin 3.0 mg/kg|3.0 mg/kg stannsoporfin (with phototherapy as needed)
10959299|NCT00850993|BG002|Baseline|Cohort 3: Stannsoporfin 4.5 mg/kg|4.5 mg/kg stannsoporfin (with phototherapy as needed)
10959300|NCT00850993|BG003|Baseline|Cohort 4: Placebo Control|Placebo control was sterile saline solution (with phototherapy as needed)
10959301|NCT00850993|BG004|Baseline|Total|Total of all reporting groups
10959302|NCT00850993|FG000|Participant Flow|Cohort 1: Stannsoporfin 1.5 mg/kg|1.5 mg/kg stannsoporfin (with phototherapy as needed)
10959303|NCT00850993|FG001|Participant Flow|Cohort 2: Stannsoporfin 3.0 mg/kg|3.0 mg/kg stannsoporfin (with phototherapy as needed)
10959304|NCT00850993|FG002|Participant Flow|Cohort 3: Stannsoporfin 4.5 mg/kg|4.5 mg/kg stannsoporfin (with phototherapy as needed)
10959305|NCT00850993|FG003|Participant Flow|Cohort 4: Placebo Control|Placebo control was sterile saline solution (with phototherapy as needed)
10959306|NCT00850993|OG000|Outcome|Cohort 1: Stannsoporfin 1.5 mg/kg|1.5 mg/kg stannsoporfin (with phototherapy as needed)
10959307|NCT00850993|OG001|Outcome|Cohort 2: Stannsoporfin 3.0 mg/kg|3.0 mg/kg stannsoporfin (with phototherapy as needed)
10959308|NCT00850993|OG002|Outcome|Cohort 3: Stannsoporfin 4.5 mg/kg|4.5 mg/kg stannsoporfin (with phototherapy as needed)
10959309|NCT00850993|OG003|Outcome|Placebo Control|Sterile saline solution (with phototherapy as needed)
10959310|NCT00850993|EG000|Reported Event|Cohort 1: Stannsoporfin 1.5 mg/kg|1.5 mg/kg stannsoporfin (with phototherapy as needed)
10959311|NCT00850993|EG001|Reported Event|Cohort 2: Stannsoporfin 3.0 mg/kg|3.0 mg/kg stannsoporfin (with phototherapy as needed)
10959312|NCT00850993|EG002|Reported Event|Cohort 3: Stannsoporfin 4.5 mg/kg|4.5 mg/kg stannsoporfin (with phototherapy as needed)
10959313|NCT00850993|EG003|Reported Event|Placebo Control|Sterile saline solution (with phototherapy as needed)
10959314|NCT00851006|BG000|Baseline|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks. Inclusion criteria were: females 13-18 years of age with a primary diagnosis of MDD. All participants were Caucasian females.
10959315|NCT00851006|FG000|Participant Flow|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks.
10959316|NCT00851006|FG001|Participant Flow|Healthy Control Group|Only 31P MRS brain scans were used from healthy individuals. HC group were not treated.
10959317|NCT00851006|OG000|Outcome|Open Label Creatine Treatment|The seven subjects who completed the protocol received creatine in the 1-8 week interval. Creatine was initiated at week 0 and terminated at week 8.
10959318|NCT00851006|OG000|Outcome|Open Label Creatine Treatment|"MDD participants' 31P MRS scans were performed prior to the first dose of creatine, and repeated following 8 weeks of treatment.~Participants were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks."
10959319|NCT00851006|OG001|Outcome|Healthy Control Group|6 healthy controls returned 8 weeks later for a follow-up scan. HC group did not receive any treatment.
10959320|NCT00851006|EG000|Reported Event|Open Label Creatine Treatment|There were no serious adverse events were experienced in this study.
11179394|NCT02055976|OG005|Outcome|PF-04950615 150 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
10959321|NCT00851006|EG001|Reported Event|Healthy Control Group|Healthy Control Group did not go through treatment. HC 31P MRS scans were only used for the study.
10959322|NCT00851084|BG000|Baseline|mFOLFOX6 Only|modified FOLFOX6
10959323|NCT00851084|BG001|Baseline|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
10959324|NCT00851084|BG002|Baseline|Total|Total of all reporting groups
10959325|NCT00851084|FG000|Participant Flow|mFOLFOX6 Only|modified FOLFOX6
10959326|NCT00851084|FG001|Participant Flow|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
10959327|NCT00851084|OG000|Outcome|mFOLFOX6 Only|modified FOLFOX6
10959328|NCT00851084|OG001|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
10959329|NCT00851084|OG000|Outcome|Negative or Missing|Negative or missing antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
10959330|NCT00851084|OG001|Outcome|Positive|Positive antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
10959331|NCT00851084|EG000|Reported Event|mFOLFOX6 Only|modified FOLFOX6
10959332|NCT00851084|EG001|Reported Event|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
10959333|NCT00851253|BG000|Baseline|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
10959334|NCT00851253|BG001|Baseline|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
10959335|NCT00851253|BG002|Baseline|Total|Total of all reporting groups
10959336|NCT00851253|FG000|Participant Flow|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
10959337|NCT00851253|FG001|Participant Flow|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
10959338|NCT00851253|OG000|Outcome|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
10959339|NCT00851253|OG001|Outcome|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
10959340|NCT00851253|EG000|Reported Event|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
10959341|NCT00851253|EG001|Reported Event|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
10959342|NCT00851279|BG000|Baseline|Magnetic Irrigated Ablation Catheter|Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
11179395|NCT02055976|EG000|Reported Event|Atorvastatin + PF-04950615 50 mg|Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11234462|NCT02435381|OG001|Outcome|Carisbamate|"Participants will receive carisbamate 600mg qd from days 2- 4.~Carisbamate: 600mg Orally on days 2-4"
10959343|NCT00851279|FG000|Participant Flow|Magnetic Irrigated Ablation Catheter|Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system
10959344|NCT00851279|OG000|Outcome|Magnetic Irrigated Ablation Catheter|Either the transseptal or transaortic approach was employed to gain access for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with RMN (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
10959345|NCT00851279|EG000|Reported Event|Magnetic Irrigated Ablation Catheter|"Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system~There were no adverse events associated with the procedure and within a 7 to 10 days post-doc window"
10959346|NCT00851318|BG000|Baseline|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959347|NCT00851318|BG001|Baseline|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959348|NCT00851318|BG002|Baseline|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959349|NCT00851318|BG003|Baseline|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959350|NCT00851318|BG004|Baseline|Total|Total of all reporting groups
10959351|NCT00851318|FG000|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959352|NCT00851318|FG001|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959353|NCT00851318|FG002|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959354|NCT00851318|FG003|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959355|NCT00851318|OG000|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959356|NCT00851318|OG001|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959357|NCT00851318|OG002|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959358|NCT00851318|OG003|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959359|NCT00851318|EG000|Reported Event|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959360|NCT00851318|EG001|Reported Event|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959361|NCT00851318|EG002|Reported Event|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
10959362|NCT00851318|EG003|Reported Event|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
11179396|NCT02055976|EG001|Reported Event|Atorvastatin + PF-04950615 100 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11234463|NCT02435381|EG000|Reported Event|Placebo First, Then Carisbamate|"Participants will receive placebo from days 2- 4.~Placebo: Placebo treatment only"
10959363|NCT00851357|BG000|Baseline|Usual Care|Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
10959364|NCT00851357|BG001|Baseline|Patch (Placebo)|Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
10959365|NCT00851357|BG002|Baseline|Patch (Real)|Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
10959366|NCT00851357|BG003|Baseline|Total|Total of all reporting groups
10959367|NCT00851357|FG000|Participant Flow|Usual Care|Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
10959368|NCT00851357|FG001|Participant Flow|Patch (Placebo)|Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
10959369|NCT00851357|FG002|Participant Flow|Patch (Real)|Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
10959370|NCT00851357|OG000|Outcome|Usual Care|Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
10959371|NCT00851357|OG001|Outcome|Patch (Placebo)|Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
10959372|NCT00851357|OG002|Outcome|Patch (Real)|Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
10959373|NCT00851357|EG000|Reported Event|Usual Care|Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
10959374|NCT00851357|EG001|Reported Event|Patch (Placebo)|Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
10959375|NCT00851357|EG002|Reported Event|Patch (Real)|Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
10959376|NCT00851409|BG000|Baseline|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
10959377|NCT00851409|FG000|Participant Flow|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
10959378|NCT00851409|OG000|Outcome|Recombinant Human C1 Inhibitor|"Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
10959379|NCT00851409|OG000|Outcome|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
10959380|NCT00851409|EG000|Reported Event|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
10959381|NCT00851630|BG000|Baseline|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
10959382|NCT00851630|BG001|Baseline|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
10959383|NCT00851630|BG002|Baseline|Total|Total of all reporting groups
10959384|NCT00851630|FG000|Participant Flow|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
10959385|NCT00851630|FG001|Participant Flow|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
11179397|NCT02055976|EG002|Reported Event|Atorvastatin + PF-04950615 150 mg|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
10959386|NCT00851630|OG000|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
10959387|NCT00851630|OG001|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
10959388|NCT00851630|EG000|Reported Event|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
10959389|NCT00851630|EG001|Reported Event|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
10959390|NCT00851643|BG000|Baseline|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959391|NCT00851643|BG001|Baseline|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959392|NCT00851643|BG002|Baseline|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959393|NCT00851643|BG003|Baseline|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959394|NCT00851643|BG004|Baseline|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959395|NCT00851643|BG005|Baseline|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959396|NCT00851643|BG006|Baseline|Total|Total of all reporting groups
10959397|NCT00851643|FG000|Participant Flow|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959398|NCT00851643|FG001|Participant Flow|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959399|NCT00851643|FG002|Participant Flow|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959400|NCT00851643|FG003|Participant Flow|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959401|NCT00851643|FG004|Participant Flow|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959402|NCT00851643|FG005|Participant Flow|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
10959403|NCT00851643|OG000|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
10959404|NCT00851643|OG001|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
10959405|NCT00851643|OG002|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
10959406|NCT00851643|OG000|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
10959407|NCT00851643|OG001|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
10959408|NCT00851643|OG002|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
10959409|NCT00851643|EG000|Reported Event|qHPV (GARDASIL™) - Phase A and Phase B Controls|Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B.
10959410|NCT00851643|EG001|Reported Event|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX.
10959411|NCT00851643|EG002|Reported Event|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX.
10959412|NCT00851643|EG003|Reported Event|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX.
10959413|NCT00851643|EG004|Reported Event|Octavalent With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX.
10959414|NCT00851721|BG000|Baseline|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
10959415|NCT00851721|BG001|Baseline|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
10959416|NCT00851721|BG002|Baseline|Total|Total of all reporting groups
10959417|NCT00851721|FG000|Participant Flow|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
10959418|NCT00851721|FG001|Participant Flow|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
10959419|NCT00851721|OG000|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
10959420|NCT00851721|OG001|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
10959421|NCT00851721|OG000|Outcome|On-demand Arm Versus Prophylaxis Arm|On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
10959422|NCT00851721|OG000|Outcome|On-demand Arm Versus Prophylaxis Arm|On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
10959423|NCT00851721|OG000|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
10959424|NCT00851721|OG000|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
10959425|NCT00851721|OG001|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
10959426|NCT00851721|OG000|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
10959427|NCT00851721|EG000|Reported Event|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
10959428|NCT00851721|EG001|Reported Event|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month ± 14 days prophylactic period
10959429|NCT00851786|BG000|Baseline|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
10959430|NCT00851786|BG001|Baseline|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
10959431|NCT00851786|BG002|Baseline|Total|Total of all reporting groups
10959432|NCT00851786|FG000|Participant Flow|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
10959433|NCT00851786|FG001|Participant Flow|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
10959434|NCT00851786|OG000|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
10959435|NCT00851786|OG001|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
10959436|NCT00851786|EG000|Reported Event|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
10959437|NCT00851786|EG001|Reported Event|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
10959438|NCT00851799|BG000|Baseline|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
10959439|NCT00851799|BG001|Baseline|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
10959440|NCT00851799|BG002|Baseline|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
10959441|NCT00851799|BG003|Baseline|Total|Total of all reporting groups
10959442|NCT00851799|FG000|Participant Flow|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
10959443|NCT00851799|FG001|Participant Flow|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
10959444|NCT00851799|FG002|Participant Flow|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
10959445|NCT00851799|OG000|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
10959446|NCT00851799|OG001|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
10959447|NCT00851799|OG002|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
10959448|NCT00851799|EG000|Reported Event|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
10959449|NCT00851799|EG001|Reported Event|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
10959450|NCT00851799|EG002|Reported Event|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
10959451|NCT00851877|BG000|Baseline|Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy|Phase I/II Cetuximab, Cisplatin and nab-paclitaxel concurrent with intensity-modulated radiotherapy.
10959452|NCT00851877|FG000|Participant Flow|Phase I Nab-paclitaxel 25 mg/m^2|Cetuximab 450mg/m^2 as a loading dose in week one. Cetuximab 250 mg/m^2, Cisplatin 20mg/m^2 and nab-paclitaxel 25mg/m^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.
10959453|NCT00851877|FG001|Participant Flow|Phase I Nab-paclitaxel 20mg/m^2|Cetuximab 450mg/m^2 as a loading dose in week one. Cetuximab 250 mg/m^2, Cisplatin 20mg/m^2 and nab-paclitaxel 20mg/m^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.
10959454|NCT00851877|FG002|Participant Flow|Phase II Nab-paclitaxel 20mg/m^2|Cetuximab 450mg/m^2 as a loading dose in week one. Cetuximab 250 mg/m^2, Cisplatin 20mg/m^2 and nab-paclitaxel 20mg/m^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.
10959455|NCT00851877|OG000|Outcome|Phase I Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy|"Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy~Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor~Cisplatin: Cisplatin is an anti-cancer chemotherapy drug~Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation~intensity-modulated radiation therapy: intensity-modulated radiation therapy"
10959456|NCT00851877|OG000|Outcome|Phase II Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy|"Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy~Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor~Cisplatin: Cisplatin is an anti-cancer chemotherapy drug~Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation~intensity-modulated radiation therapy: intensity-modulated radiation therapy"
10959457|NCT00851877|OG000|Outcome|Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy|"Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy~Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor~Cisplatin: Cisplatin is an anti-cancer chemotherapy drug~Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation~intensity-modulated radiation therapy: intensity-modulated radiation therapy"
10959458|NCT00851877|EG000|Reported Event|Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy|"Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy~Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor~Cisplatin: Cisplatin is an anti-cancer chemotherapy drug~Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation~intensity-modulated radiation therapy: intensity-modulated radiation therapy"
10959459|NCT00851890|BG000|Baseline|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959460|NCT00851890|BG001|Baseline|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959461|NCT00851890|BG002|Baseline|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959462|NCT00851890|BG003|Baseline|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959463|NCT00851890|BG004|Baseline|Total|Total of all reporting groups
10959464|NCT00851890|FG000|Participant Flow|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959465|NCT00851890|FG001|Participant Flow|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959466|NCT00851890|FG002|Participant Flow|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959467|NCT00851890|FG003|Participant Flow|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959468|NCT00851890|OG000|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959469|NCT00851890|OG001|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959470|NCT00851890|OG002|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959471|NCT00851890|OG003|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959472|NCT00851890|EG000|Reported Event|ABT-333 (300 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959473|NCT00851890|EG001|Reported Event|ABT-333 (600 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959474|NCT00851890|EG002|Reported Event|ABT-333 (1200 mg) Once Daily (QD) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
10959475|NCT00851890|EG003|Reported Event|Placebo + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
11179398|NCT02055976|EG003|Reported Event|Atorvastatin + PF-04950615 Placebo|Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
11179399|NCT02055976|EG004|Reported Event|Atorvastatin + Ezetimibe 10 mg QD PO|Participants received Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open).
10959476|NCT00851903|BG000|Baseline|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
10959477|NCT00851903|FG000|Participant Flow|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
10959478|NCT00851903|OG000|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
10959479|NCT00851903|EG000|Reported Event|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
10959480|NCT00852137|BG000|Baseline|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10959481|NCT00852137|BG001|Baseline|Vehicle|Vehicle gel once daily for 2 consecutive days
10959482|NCT00852137|BG002|Baseline|Total|Total of all reporting groups
10959483|NCT00852137|FG000|Participant Flow|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
11179400|NCT02055976|EG005|Reported Event|PF-04950615 50 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
11179401|NCT02055976|EG006|Reported Event|PF-04950615 100 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
11179402|NCT02055976|EG007|Reported Event|PF-04950615 150 mg|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
11179403|NCT02055976|EG008|Reported Event|PF-04950615 Placebo|Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
11179404|NCT02056171|BG000|Baseline|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
11179405|NCT02056171|BG001|Baseline|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
11179406|NCT02056171|BG002|Baseline|Total|Total of all reporting groups
10959484|NCT00852137|FG001|Participant Flow|Vehicle|Vehicle gel once daily for 2 consecutive days
10959485|NCT00852137|OG000|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10959486|NCT00852137|OG001|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
10959487|NCT00852137|EG000|Reported Event|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
10959488|NCT00852137|EG001|Reported Event|Vehicle|Vehicle gel once daily for 2 consecutive days
10959489|NCT00852202|BG000|Baseline|Placebo|Matching placebo capsules, orally administered for 8 weeks
10959490|NCT00852202|BG001|Baseline|0.25 to 0.75 mg Cariprazine|Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
11179407|NCT02056171|FG000|Participant Flow|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
11179408|NCT02056171|FG001|Participant Flow|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
11179409|NCT02056171|OG000|Outcome|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
11179410|NCT02056171|OG001|Outcome|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
11179411|NCT02056171|EG000|Reported Event|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
11179412|NCT02056171|EG001|Reported Event|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
10959491|NCT00852202|BG002|Baseline|1.5 to 3.0 mg Cariprazine|Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks
10959492|NCT00852202|BG003|Baseline|Total|Total of all reporting groups
10959493|NCT00852202|FG000|Participant Flow|Placebo|Matching placebo capsules, orally administered for 8 weeks
10959494|NCT00852202|FG001|Participant Flow|0.25 to 0.75 mg Cariprazine|Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
10959495|NCT00852202|FG002|Participant Flow|1.5 to 3.0 mg Cariprazine|1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks
10959496|NCT00852202|OG000|Outcome|Placebo|Matching placebo capsules, orally administered for 8 weeks
10959497|NCT00852202|OG001|Outcome|0.25 to 0.75 mg Cariprazine|Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
10959498|NCT00852202|OG002|Outcome|1.5 to 3.0 mg Cariprazine|Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks
10959499|NCT00852202|OG002|Outcome|1.5 to 3.0mg Cariprazine|Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks
10959500|NCT00852202|EG000|Reported Event|Placebo|Matching placebo capsules, orally administered for 8 weeks
10959501|NCT00852202|EG001|Reported Event|0.25 to 0.75 mg Cariprazine|Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
10959502|NCT00852202|EG002|Reported Event|1.5 to 3.0 mg Cariprazine|1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks
10959503|NCT00852397|BG000|Baseline|Placebo|"Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
10959504|NCT00852397|BG001|Baseline|Apixaban 2.5 mg BID|"2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
10959505|NCT00852397|BG002|Baseline|Apixaban 5.0 mg BID|"Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
10959506|NCT00852397|BG003|Baseline|Total|Total of all reporting groups
10959507|NCT00852397|FG000|Participant Flow|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959508|NCT00852397|FG001|Participant Flow|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959509|NCT00852397|FG002|Participant Flow|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959510|NCT00852397|OG000|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959511|NCT00852397|OG001|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959512|NCT00852397|OG002|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959513|NCT00852397|EG000|Reported Event|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959514|NCT00852397|EG001|Reported Event|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959515|NCT00852397|EG002|Reported Event|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
10959516|NCT00852475|BG000|Baseline|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
10959517|NCT00852475|BG001|Baseline|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
10959518|NCT00852475|BG002|Baseline|Total|Total of all reporting groups
10959519|NCT00852475|FG000|Participant Flow|MUFA|"Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program"
10959520|NCT00852475|FG001|Participant Flow|PUFA|"Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
10959521|NCT00852475|OG000|Outcome|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
10959522|NCT00852475|OG001|Outcome|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
10959523|NCT00852475|OG000|Outcome|MUFA Arm|Assessment of FMD after six months of MUFA enrichment
10959524|NCT00852475|OG001|Outcome|PUFA Arm|Assessment of FMD after 6 months of PUFA enrichment
10959525|NCT00852475|EG000|Reported Event|MUFA|subjects received a diet enriched in MUFA
10959526|NCT00852475|EG001|Reported Event|PUFA|subjects received a diet enriched in PUFA
10959527|NCT00852527|BG000|Baseline|OEF/OIF Veterans|Operation Enduring Freedom /Operation Iraqi Freedom (OEF/OIF) Veterans seeking care at one of three VA Polytrauma Network Sites (PNS) who screen positive or negative for mild traumatic brain injury.
10959528|NCT00852527|FG000|Participant Flow|Positive Mild TBI|Participants who screened positive on the TBI Clinical Reminder Screen
10959529|NCT00852527|FG001|Participant Flow|Negative Mild TBI|Participants who screened negative on the TBI Clinical Reminder Screen
10959530|NCT00852527|OG000|Outcome|Veterans Assessed With the Comprehensive TBI Evaluation|
10959531|NCT00852527|OG001|Outcome|Veterans Assessed With the Structured TBI Diagnostic Interview|
10959532|NCT00852527|EG000|Reported Event|OEF/OIF Veterans|No adverse events.
10959533|NCT00852540|BG000|Baseline|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
10959534|NCT00852540|BG001|Baseline|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
10959535|NCT00852540|BG002|Baseline|Total|Total of all reporting groups
10959536|NCT00852540|FG000|Participant Flow|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
10959537|NCT00852540|FG001|Participant Flow|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
10959538|NCT00852540|OG000|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
10959539|NCT00852540|OG001|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
11234464|NCT02435381|EG001|Reported Event|Carisbamate First, Then Placebo|"Participants will receive carisbamate 600mg qd from days 2- 4.~Carisbamate: 600mg Orally on days 2-4"
10959540|NCT00852540|OG001|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
10959541|NCT00852540|EG000|Reported Event|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
10959542|NCT00852540|EG001|Reported Event|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
10959543|NCT00852592|BG000|Baseline|Active Comparator|"active light unit~active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
10959544|NCT00852592|BG001|Baseline|Inactive Comparator|"inactive light unit~Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily"
10959545|NCT00852592|BG002|Baseline|Total|Total of all reporting groups
10959546|NCT00852592|FG000|Participant Flow|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
10959547|NCT00852592|FG001|Participant Flow|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
10959548|NCT00852592|OG000|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
10959549|NCT00852592|OG001|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
10959550|NCT00852592|EG000|Reported Event|Active Comparator|"active light unit~active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
10959551|NCT00852592|EG001|Reported Event|Inactive Comparator|inactive light unit Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
10959552|NCT00852631|BG000|Baseline|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
10959553|NCT00852631|FG000|Participant Flow|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
10959554|NCT00852631|OG000|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
10959555|NCT00852631|EG000|Reported Event|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
10959556|NCT00852644|BG000|Baseline|CyberKnife|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959557|NCT00852644|FG000|Participant Flow|56 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959558|NCT00852644|FG001|Participant Flow|62 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959559|NCT00852644|FG002|Participant Flow|68 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959560|NCT00852644|FG003|Participant Flow|56 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959561|NCT00852644|FG004|Participant Flow|62 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks a 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959562|NCT00852644|FG005|Participant Flow|68 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959563|NCT00852644|OG000|Outcome|56 Gray (LESS Than 3 Centimeter Cohort)|Dose 1 (56 gray), less than 3 centimeter cohort
10959564|NCT00852644|OG001|Outcome|62 Gray (LESS Less Than 3 Centimeter Cohort)|Dose 2 (62 gray), less than 3 centimeter cohort
10959565|NCT00852644|OG002|Outcome|68 Gray (LESS Than 3 Centimeter Cohort)|Dose 3 (68 gray), less than 3 centimeter cohort
10959566|NCT00852644|OG000|Outcome|56 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
10959567|NCT00852644|OG001|Outcome|62 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
10959568|NCT00852644|OG002|Outcome|68 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
10959569|NCT00852644|OG000|Outcome|CyberKnife|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959570|NCT00852644|EG000|Reported Event|56 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959571|NCT00852644|EG001|Reported Event|62 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10963848|NCT00874549|FG003|Participant Flow|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
10959572|NCT00852644|EG002|Reported Event|68 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959573|NCT00852644|EG003|Reported Event|56 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959574|NCT00852644|EG004|Reported Event|62 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959575|NCT00852644|EG005|Reported Event|68 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
10959576|NCT00852761|BG000|Baseline|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
10959577|NCT00852761|BG001|Baseline|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
10959578|NCT00852761|BG002|Baseline|Total|Total of all reporting groups
10959579|NCT00852761|FG000|Participant Flow|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
10959580|NCT00852761|FG001|Participant Flow|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
10959581|NCT00852761|OG000|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
10959582|NCT00852761|OG001|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
10959583|NCT00852761|EG000|Reported Event|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
10959584|NCT00852761|EG001|Reported Event|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
10959585|NCT00852917|BG000|Baseline|1: Tramadol Once A Day 100mg|
10959586|NCT00852917|BG001|Baseline|2: Tramadol Once A Day 200mg|
10959587|NCT00852917|BG002|Baseline|3: Tramadol Once A Day 300mg|
10959588|NCT00852917|BG003|Baseline|4: Placebo|
10959589|NCT00852917|BG004|Baseline|Total|Total of all reporting groups
10959590|NCT00852917|FG000|Participant Flow|1: Tramadol Once A Day 100mg|
10959591|NCT00852917|FG001|Participant Flow|2: Tramadol Once A Day 200mg|
10959592|NCT00852917|FG002|Participant Flow|3: Tramadol Once A Day 300mg|
10959593|NCT00852917|FG003|Participant Flow|4: Placebo|
10959594|NCT00852917|OG000|Outcome|1: Tramadol Once A Day 100mg|
10959595|NCT00852917|OG001|Outcome|2: Tramadol Once A Day 200mg|
10959596|NCT00852917|OG002|Outcome|3: Tramadol Once A Day 300mg|
10959597|NCT00852917|OG003|Outcome|4: Placebo|
10959598|NCT00852917|EG000|Reported Event|1: Tramadol Once A Day 100mg|
10959599|NCT00852917|EG001|Reported Event|2: Tramadol Once A Day 200mg|
10959600|NCT00852917|EG002|Reported Event|3: Tramadol Once A Day 300mg|
10959601|NCT00852917|EG003|Reported Event|4: Placebo|
10959602|NCT00852930|BG000|Baseline|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
10959603|NCT00852930|BG001|Baseline|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
10959604|NCT00852930|BG002|Baseline|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
10959605|NCT00852930|BG003|Baseline|Total|Total of all reporting groups
10959606|NCT00852930|FG000|Participant Flow|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
10959607|NCT00852930|FG001|Participant Flow|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
10959608|NCT00852930|FG002|Participant Flow|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
10959609|NCT00852930|OG000|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
10959610|NCT00852930|OG001|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
10959611|NCT00852930|OG002|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
10959612|NCT00852930|OG001|Outcome|Mld Alone|"therapist administered manual lymphatic drainage (mld)~manual lymphatic drainage: therapist administered massage therapy"
10959613|NCT00852930|EG000|Reported Event|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser~No adverse events during the study."
10959614|NCT00852930|EG001|Reported Event|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy~No adverse events during the study."
10959615|NCT00852930|EG002|Reported Event|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment~No adverse events during the study."
10959616|NCT00852969|BG000|Baseline|Niacin|Niacin : 1000 mg tablets once per day
10959617|NCT00852969|BG001|Baseline|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
10959618|NCT00852969|BG002|Baseline|Total|Total of all reporting groups
10959619|NCT00852969|FG000|Participant Flow|Niacin|Niacin : 1000 mg tablets once per day
10959620|NCT00852969|FG001|Participant Flow|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
10959621|NCT00852969|OG000|Outcome|Niacin|Niacin : 1000 mg tablets once per day
10959622|NCT00852969|OG001|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
10959623|NCT00852969|EG000|Reported Event|Niacin|Niacin : 1000 mg tablets once per day
10959624|NCT00852969|EG001|Reported Event|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
10959625|NCT00852995|BG000|Baseline|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution"
10959626|NCT00852995|BG001|Baseline|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959627|NCT00852995|BG002|Baseline|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959628|NCT00852995|BG003|Baseline|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959629|NCT00852995|BG004|Baseline|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959630|NCT00852995|BG005|Baseline|Total|Total of all reporting groups
11179413|NCT02056288|BG000|Baseline|Ultrasound Guided Supraclavicular Block|"Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.~Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml)."
10959631|NCT00852995|FG000|Participant Flow|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959632|NCT00852995|FG001|Participant Flow|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959633|NCT00852995|FG002|Participant Flow|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959634|NCT00852995|FG003|Participant Flow|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959635|NCT00852995|FG004|Participant Flow|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution"
10959636|NCT00852995|OG000|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959637|NCT00852995|OG001|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959638|NCT00852995|OG002|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959639|NCT00852995|OG003|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959640|NCT00852995|OG004|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution"
10959641|NCT00852995|OG000|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution"
10959642|NCT00852995|OG001|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959643|NCT00852995|OG002|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959644|NCT00852995|OG003|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959645|NCT00852995|OG004|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959646|NCT00852995|EG000|Reported Event|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution"
10959647|NCT00852995|EG001|Reported Event|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959648|NCT00852995|EG002|Reported Event|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959649|NCT00852995|EG003|Reported Event|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959650|NCT00852995|EG004|Reported Event|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
10959651|NCT00853021|BG000|Baseline|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
10959652|NCT00853021|FG000|Participant Flow|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
10959653|NCT00853021|OG000|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
10959654|NCT00853021|EG000|Reported Event|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
11179414|NCT02056288|BG001|Baseline|IV Opioids|"Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.~Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction."
10959655|NCT00853047|BG000|Baseline|Placebo Core Phase|Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
10959656|NCT00853047|BG001|Baseline|Telotristat Etiprate 150 mg Core Phase|Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959657|NCT00853047|BG002|Baseline|Telotristat Etiprate 250 mg Core Phase|Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959658|NCT00853047|BG003|Baseline|Telotristat Etiprate 350 mg Core Phase|Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959659|NCT00853047|BG004|Baseline|Telotristat Etiprate 500 mg Core Phase|Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959660|NCT00853047|BG005|Baseline|Total|Total of all reporting groups
10959661|NCT00853047|FG000|Participant Flow|Placebo Core Phase|Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
10959662|NCT00853047|FG001|Participant Flow|Telotristat Etiprate 150 mg Core Phase|Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959663|NCT00853047|FG002|Participant Flow|Telotristat Etiprate 250 mg Core Phase|Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
11179415|NCT02056288|BG002|Baseline|Total|Total of all reporting groups
10959664|NCT00853047|FG003|Participant Flow|Telotristat Etiprate 350 mg Core Phase|Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959665|NCT00853047|FG004|Participant Flow|Telotristat Etiprate 500 mg Core Phase|Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959666|NCT00853047|FG005|Participant Flow|Telotristat Etiprate Open-Label Extension Phase|Participants received telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
10959667|NCT00853047|OG000|Outcome|Placebo Core Phase|Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
10959668|NCT00853047|OG001|Outcome|Telotristat Etiprate 150 mg Core Phase|Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959669|NCT00853047|OG002|Outcome|Telotristat Etiprate 250 mg Core Phase|Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959670|NCT00853047|OG003|Outcome|Telotristat Etiprate 350 mg Core Phase|Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959671|NCT00853047|OG004|Outcome|Telotristat Etiprate 500 mg Core Phase|Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959672|NCT00853047|OG000|Outcome|Telotristat Etiprate Open-Label Extension Phase|Participants received telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
10959673|NCT00853047|OG001|Outcome|Telotristat Etiprate 500 mg Core Phase|Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959674|NCT00853047|EG000|Reported Event|Placebo Core Phase|Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
10959675|NCT00853047|EG001|Reported Event|Telotristat Etiprate 150 mg Core Phase|Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959676|NCT00853047|EG002|Reported Event|Telotristat Etiprate 250 mg Core Phase|Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959677|NCT00853047|EG003|Reported Event|Telotristat Etiprate 350 mg Core Phase|Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959678|NCT00853047|EG004|Reported Event|Telotristat Etiprate 500 mg Core Phase|Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
10959679|NCT00853047|EG005|Reported Event|Telotristat Etiprate Open-Label Extension Phase|Participants received telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
10959680|NCT00853073|BG000|Baseline|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
10959681|NCT00853073|BG001|Baseline|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
10959682|NCT00853073|BG002|Baseline|Total|Total of all reporting groups
10959683|NCT00853073|FG000|Participant Flow|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
10959684|NCT00853073|FG001|Participant Flow|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
10959685|NCT00853073|OG000|Outcome|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
10959686|NCT00853073|OG001|Outcome|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
10959687|NCT00853073|EG000|Reported Event|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
10959688|NCT00853073|EG001|Reported Event|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
10959689|NCT00853099|BG000|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
10959690|NCT00853099|BG001|Baseline|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
10959691|NCT00853099|BG002|Baseline|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
10959692|NCT00853099|BG003|Baseline|Total|Total of all reporting groups
10959693|NCT00853099|FG000|Participant Flow|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
10959694|NCT00853099|FG001|Participant Flow|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
10959695|NCT00853099|FG002|Participant Flow|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
10959696|NCT00853099|FG003|Participant Flow|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
10959697|NCT00853099|OG000|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
10959698|NCT00853099|OG001|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
10959699|NCT00853099|OG002|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
10959700|NCT00853099|OG000|Outcome|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
10959701|NCT00853099|EG000|Reported Event|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
10959702|NCT00853099|EG001|Reported Event|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
10959703|NCT00853099|EG002|Reported Event|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
10959704|NCT00853099|EG003|Reported Event|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
10959705|NCT00853112|BG000|Baseline|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
10959706|NCT00853112|BG001|Baseline|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959707|NCT00853112|BG002|Baseline|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959708|NCT00853112|BG003|Baseline|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
10959709|NCT00853112|BG004|Baseline|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
11179416|NCT02056288|FG000|Participant Flow|Ultrasound Guided Supraclavicular Block|"Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.~Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml)."
11179417|NCT02056288|FG001|Participant Flow|IV Opioids|"Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.~Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction."
11179418|NCT02056288|OG000|Outcome|Ultrasound Guided Supraclavicular Block|"Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.~Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml)."
11179419|NCT02056288|OG001|Outcome|IV Opioids|"Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.~Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction."
10959710|NCT00853112|BG005|Baseline|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
10959711|NCT00853112|BG006|Baseline|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
10959712|NCT00853112|BG007|Baseline|Total|Total of all reporting groups
10959713|NCT00853112|FG000|Participant Flow|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
10959714|NCT00853112|FG001|Participant Flow|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959715|NCT00853112|FG002|Participant Flow|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959716|NCT00853112|FG003|Participant Flow|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
10959717|NCT00853112|FG004|Participant Flow|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959718|NCT00853112|FG005|Participant Flow|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
10959719|NCT00853112|FG006|Participant Flow|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
10959720|NCT00853112|OG000|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
10959721|NCT00853112|OG001|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959722|NCT00853112|OG002|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959723|NCT00853112|OG003|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
10959724|NCT00853112|OG004|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959725|NCT00853112|OG005|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
10959726|NCT00853112|OG006|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
10959727|NCT00853112|EG000|Reported Event|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
10959728|NCT00853112|EG001|Reported Event|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959729|NCT00853112|EG002|Reported Event|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959730|NCT00853112|EG003|Reported Event|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
10959731|NCT00853112|EG004|Reported Event|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
10959732|NCT00853112|EG005|Reported Event|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
10959733|NCT00853112|EG006|Reported Event|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
11179420|NCT02056288|EG000|Reported Event|Ultrasound Guided Supraclavicular Block|"Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.~Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml)."
11179421|NCT02056288|EG001|Reported Event|IV Opioids|"Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.~Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction."
11179422|NCT02056301|BG000|Baseline|Patient Controlled Analgesia|"One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.~Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes"
10959734|NCT00853125|BG000|Baseline|Sunitinib Plus Irradiated Allogeneic Lymphocytes|"therapeutic allogeneic lymphocytes: Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response~sunitinib malate: Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle."
10959735|NCT00853125|FG000|Participant Flow|Sunitinib Plus Irradiated Allogeneic Lymphocytes|"therapeutic allogeneic lymphocytes: Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response~sunitinib malate: Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle."
10959736|NCT00853125|OG000|Outcome|Sunitinib Plus Irradiated Allogeneic Lymphocytes|"Therapeutic allogeneic lymphocytes: Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response~sunitinib malate: Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle."
10959737|NCT00853125|OG000|Outcome|Sunitinib Plus Irradiated Allogeneic Lymphocytes|"Therapeutic Allogeneic Lymphocytes: patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response.~Sunitinib malate: Sunitinib will be administered orally at adose 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle."
10959738|NCT00853125|EG000|Reported Event|Sunitinib Plus Irradiated Allogeneic Lymphocytes|"therapeutic allogeneic lymphocytes: Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response~sunitinib malate: Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle."
10959739|NCT00853151|BG000|Baseline|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
10959740|NCT00853151|BG001|Baseline|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
10959741|NCT00853151|BG002|Baseline|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
10959742|NCT00853151|BG003|Baseline|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
10959743|NCT00853151|BG004|Baseline|Total|Total of all reporting groups
10959744|NCT00853151|FG000|Participant Flow|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
10959745|NCT00853151|FG001|Participant Flow|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
10959746|NCT00853151|FG002|Participant Flow|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
10959747|NCT00853151|FG003|Participant Flow|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
10959748|NCT00853151|OG000|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
10959749|NCT00853151|OG001|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
10959750|NCT00853151|OG002|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
10959751|NCT00853151|OG003|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
10959752|NCT00853151|OG000|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
10959753|NCT00853151|OG001|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
10959754|NCT00853151|OG001|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
11179423|NCT02056301|BG001|Baseline|Epidural Catheter|"The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.~Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision."
11179424|NCT02056301|BG002|Baseline|Total|Total of all reporting groups
11179425|NCT02056301|FG000|Participant Flow|Patient Controlled Analgesia|"One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.~Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes"
10959755|NCT00853151|EG000|Reported Event|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
10959756|NCT00853151|EG001|Reported Event|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
10959757|NCT00853151|EG002|Reported Event|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
10959758|NCT00853151|EG003|Reported Event|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
10959759|NCT00853242|BG000|Baseline|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
10959760|NCT00853242|BG001|Baseline|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959761|NCT00853242|BG002|Baseline|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959762|NCT00853242|BG003|Baseline|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959763|NCT00853242|BG004|Baseline|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959764|NCT00853242|BG005|Baseline|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959765|NCT00853242|BG006|Baseline|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959766|NCT00853242|BG007|Baseline|Total|Total of all reporting groups
10959767|NCT00853242|FG000|Participant Flow|Placebo|Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
10959768|NCT00853242|FG001|Participant Flow|Genz-644470 2.4 Grams Per Day (g/Day)|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959769|NCT00853242|FG002|Participant Flow|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959770|NCT00853242|FG003|Participant Flow|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959771|NCT00853242|FG004|Participant Flow|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959772|NCT00853242|FG005|Participant Flow|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959773|NCT00853242|FG006|Participant Flow|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959774|NCT00853242|OG000|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
10959775|NCT00853242|OG001|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959776|NCT00853242|OG002|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959777|NCT00853242|OG003|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959778|NCT00853242|OG000|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959779|NCT00853242|OG001|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959780|NCT00853242|OG002|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959781|NCT00853242|OG003|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959782|NCT00853242|OG004|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959783|NCT00853242|OG005|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959784|NCT00853242|OG004|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959785|NCT00853242|OG005|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959786|NCT00853242|OG006|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959787|NCT00853242|EG000|Reported Event|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
10959788|NCT00853242|EG001|Reported Event|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959789|NCT00853242|EG002|Reported Event|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959790|NCT00853242|EG003|Reported Event|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959791|NCT00853242|EG004|Reported Event|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
10959792|NCT00853242|EG005|Reported Event|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
10959793|NCT00853242|EG006|Reported Event|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
10959794|NCT00853333|BG000|Baseline|Dexmedetomidine|
10959795|NCT00853333|BG001|Baseline|Midazolam|
11179426|NCT02056301|FG001|Participant Flow|Epidural Catheter|"The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.~Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision."
10959796|NCT00853333|BG002|Baseline|Propofol|
10959797|NCT00853333|BG003|Baseline|Total|Total of all reporting groups
10959798|NCT00853333|FG000|Participant Flow|Dexmedetomidine|Sedation Arm 1, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
10959799|NCT00853333|FG001|Participant Flow|Midazolam|Sedation Arm 2, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
10959800|NCT00853333|FG002|Participant Flow|Propofol|Sedation Arm 3, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
10959801|NCT00853333|OG000|Outcome|Dexmedetomidine|
10959802|NCT00853333|OG001|Outcome|Midazolam|
10959803|NCT00853333|OG002|Outcome|Propofol|
10959804|NCT00853333|EG000|Reported Event|Dexmedetomidine|
10959805|NCT00853333|EG001|Reported Event|Midazolam|
10959806|NCT00853333|EG002|Reported Event|Propofol|
10959807|NCT00853372|BG000|Baseline|Trebananib 10 mg/kg + Sunitinib|Trebananib 10 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off
10959808|NCT00853372|BG001|Baseline|Trebananib 15 mg/kg + Sunitinib|Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off
10959809|NCT00853372|BG002|Baseline|Total|Total of all reporting groups
10959810|NCT00853372|FG000|Participant Flow|Trebananib 10 mg/kg + Sunitinib|Trebananib 10 mg/kg intravenously (IV) once weekly (QW) plus sunitinib 50 mg orally (PO) once daily (QD) 4 weeks on/2 weeks off
10959811|NCT00853372|FG001|Participant Flow|Trebananib 15 mg/kg + Sunitinib|Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off
10959812|NCT00853372|OG000|Outcome|Trebananib 10 mg/kg + Sunitinib|Trebananib 10 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off
10959813|NCT00853372|OG001|Outcome|Trebananib 15 mg/kg + Sunitinib|Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off
10959814|NCT00853372|EG000|Reported Event|Trebananib 10 mg/kg + Sunitinib|Trebananib 10 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off
10959815|NCT00853372|EG001|Reported Event|Trebananib 15 mg/kg + Sunitinib|Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off
10959816|NCT00853385|BG000|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959817|NCT00853385|BG001|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959818|NCT00853385|BG002|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10963849|NCT00874549|OG000|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
10963850|NCT00874549|OG001|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
10959819|NCT00853385|BG003|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959820|NCT00853385|BG004|Baseline|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
10959821|NCT00853385|BG005|Baseline|Total|Total of all reporting groups
10959822|NCT00853385|FG000|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959823|NCT00853385|FG001|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959824|NCT00853385|FG002|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959825|NCT00853385|FG003|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959826|NCT00853385|FG004|Participant Flow|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
10959827|NCT00853385|OG000|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959828|NCT00853385|OG001|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959829|NCT00853385|OG002|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959830|NCT00853385|OG003|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
10959831|NCT00853385|OG002|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
11179427|NCT02056301|OG000|Outcome|Patient Controlled Analgesia|"One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.~Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes"
10959832|NCT00853385|OG003|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959833|NCT00853385|OG004|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
10963851|NCT00874549|OG002|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
10959834|NCT00853385|OG002|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959835|NCT00853385|OG003|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
11179428|NCT02056301|OG001|Outcome|Epidural Catheter|"The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.~Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision."
11179429|NCT02056301|EG000|Reported Event|Patient Controlled Analgesia|"One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.~Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes"
11179430|NCT02056301|EG001|Reported Event|Epidural Catheter|"The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.~Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision."
11179431|NCT02056340|BG000|Baseline|Atorvastatin|"Patients will be administered study medication (atorvastatin 40 mg) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.~Atorvastatin"
11179432|NCT02056340|BG001|Baseline|Placebo|"Patients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.~Placebo"
11179433|NCT02056340|BG002|Baseline|Total|Total of all reporting groups
11179434|NCT02056340|FG000|Participant Flow|Atorvastatin|"Patients will be administered study medication (atorvastatin 40 mg) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.~Atorvastatin"
11179435|NCT02056340|FG001|Participant Flow|Placebo|"Patients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.~Placebo"
11179436|NCT02056340|OG000|Outcome|Atorvastatin|"Patients will be administered study medication (atorvastatin 40 mg) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.~Atorvastatin"
11179437|NCT02056340|OG001|Outcome|Placebo|"Patients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.~Placebo"
11179438|NCT02056340|EG000|Reported Event|Atorvastatin|"Patients will be administered study medication (atorvastatin 40 mg) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.~Atorvastatin"
11179439|NCT02056340|EG001|Reported Event|Placebo|"Patients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.~Placebo"
11179440|NCT02056392|BG000|Baseline|Selumetinib/Moxifloxacin/Selumetinib Placebo|
11179441|NCT02056392|BG001|Baseline|Moxifloxacin/Selumetinib/Selumetinib Placebo|
11179442|NCT02056392|BG002|Baseline|Moxifloxacin/Selumetinib Placebo/Selumetinib|
11179443|NCT02056392|BG003|Baseline|Selumetinib Placebo/Moxifloxacin/Selumetinib|
11179444|NCT02056392|BG004|Baseline|Selumetinib Placebo/Selumetinib/Moxifloxacin|
11179445|NCT02056392|BG005|Baseline|Selumetinib/Selumetinib Placebo/Moxifloxacin|
11179446|NCT02056392|BG006|Baseline|Total|Total of all reporting groups
11179447|NCT02056392|FG000|Participant Flow|Selumetinib/Moxifloxacin/Selumetinib Placebo|
11179448|NCT02056392|FG001|Participant Flow|Moxifloxacin/Selumetinib/Selumetinib Placebo|
11179449|NCT02056392|FG002|Participant Flow|Moxifloxacin/Selumetinib Placebo/Selumetinib|
11179450|NCT02056392|FG003|Participant Flow|Selumetinib Placebo/Moxifloxacin/Selumetinib|
11179451|NCT02056392|FG004|Participant Flow|Selumetinib Placebo/Selumetinib/Moxifloxacin|
11179452|NCT02056392|FG005|Participant Flow|Selumetinib/Selumetinib Placebo/Moxifloxacin|
11179453|NCT02056392|OG000|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
11179454|NCT02056392|OG001|Outcome|Placebo|Selumetinib placebo (3 capsules)
11179455|NCT02056392|OG002|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
10959836|NCT00853385|EG000|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
10959837|NCT00853385|EG001|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
10959838|NCT00853385|EG002|Reported Event|Placebo (Up To Month 3)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959839|NCT00853385|EG003|Reported Event|Adalimumab (Up To Month 3)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
10959840|NCT00853385|EG004|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
10959841|NCT00853385|EG005|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
10959842|NCT00853385|EG006|Reported Event|Placebo (Month 3 to 6)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
10959843|NCT00853385|EG007|Reported Event|Adalimumab (Month 3 to 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
10959844|NCT00853385|EG008|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
10959845|NCT00853385|EG009|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
10959846|NCT00853385|EG010|Reported Event|Adalimumab (Post Month 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
10959847|NCT00853489|BG000|Baseline|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
10959848|NCT00853489|BG001|Baseline|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
10959849|NCT00853489|BG002|Baseline|Total|Total of all reporting groups
10959850|NCT00853489|FG000|Participant Flow|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
10959851|NCT00853489|FG001|Participant Flow|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
10959852|NCT00853489|OG000|Outcome|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
10959853|NCT00853489|OG001|Outcome|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
10959854|NCT00853489|EG000|Reported Event|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
10959855|NCT00853489|EG001|Reported Event|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
10959856|NCT00853580|BG000|Baseline|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
11179456|NCT02056392|EG000|Reported Event|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
10959857|NCT00853580|BG001|Baseline|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
10959858|NCT00853580|BG002|Baseline|Total|Total of all reporting groups
11179457|NCT02056392|EG001|Reported Event|Moxifloxacin|Moxiflxacin 400 mg (open label)
11179458|NCT02056392|EG002|Reported Event|Placebo|Selumetinib placebo (3 capsules)
10959859|NCT00853580|FG000|Participant Flow|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
10959860|NCT00853580|FG001|Participant Flow|Placebo|Look alike placebo pill with same dosing schedule as active lovastatin.
10959861|NCT00853580|OG000|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
10959862|NCT00853580|OG001|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
10959863|NCT00853580|EG000|Reported Event|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
10959864|NCT00853580|EG001|Reported Event|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
10959865|NCT00853593|BG000|Baseline|Model 4396 LV Lead|Subjects underwent Model 4396 left ventricular lead implant attempt
11179459|NCT02056431|BG000|Baseline|IVR Intervention Group|"Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.~IVR Intervention Group: 595 participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians."
11179460|NCT02056431|BG001|Baseline|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
10959866|NCT00853593|FG000|Participant Flow|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
10959867|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects who underwent a Model 4396 left ventricular lead implant attempt
10959868|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with tip electrode capture at 0.5ms at 1-month.
10959869|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month.
10959870|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
10959871|NCT00853593|OG000|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt with successful CS cannulation.
11179461|NCT02056431|BG002|Baseline|Total|Total of all reporting groups
11179462|NCT02056431|FG000|Participant Flow|IVR Intervention Group|Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.
11179463|NCT02056431|FG001|Participant Flow|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
11179464|NCT02056431|OG000|Outcome|IVR Intervention Group|Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.
10959872|NCT00853593|OG000|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt.
10959873|NCT00853593|OG000|Outcome|Any Medtronic LV Lead (Attain Family Lead)|Subjects who underwent an implant attempt.
10959874|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Model 4396 lead implant attempts.
10959875|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead and completed 1 month visit.
10959876|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with tip electrode threshold captured at 0.5ms at 6 month.
10959877|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with tip electrode pacing impedance at 6 month.
10959878|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at 6 month.
10959879|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5 ms at 6 month.
10959880|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with ring electrode pacing impedance at 6 month.
10959881|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at implant.
10959882|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration threshold captured at 0.5ms at 6 month.
10959883|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration pacing impedance at 6 month.
10959884|NCT00853593|OG000|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration R-wave amplitude at 6 month.
10959885|NCT00853593|EG000|Reported Event|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
10959886|NCT00853606|BG000|Baseline|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
10959887|NCT00853606|FG000|Participant Flow|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
10959888|NCT00853606|OG000|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
10959889|NCT00853606|EG000|Reported Event|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
11179465|NCT02056431|OG001|Outcome|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
11179466|NCT02056431|OG000|Outcome|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th,and 6th months post start date) containing generic messages regarding diabetes education
10959890|NCT00853645|BG000|Baseline|Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System|Single-arm with 6 patients implanted with an S-ICD System
10959891|NCT00853645|FG000|Participant Flow|Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System|Single-arm with 6 patients implanted with an S-ICD System
10959892|NCT00853645|OG000|Outcome|Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System|Single-arm with 6 patients implanted with an S-ICD System
10959893|NCT00853645|EG000|Reported Event|Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System|Single-arm with 6 patients implanted with an Subcutaneous implantable cardioverter defibrillator (S-ICD) System
10959894|NCT00853658|BG000|Baseline|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
10959895|NCT00853658|BG001|Baseline|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
10959896|NCT00853658|BG002|Baseline|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
10959897|NCT00853658|BG003|Baseline|Total|Total of all reporting groups
10959898|NCT00853658|FG000|Participant Flow|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
10959899|NCT00853658|FG001|Participant Flow|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
10959900|NCT00853658|FG002|Participant Flow|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
10959901|NCT00853658|OG000|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
10959902|NCT00853658|OG001|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
10959903|NCT00853658|OG002|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
10959904|NCT00853658|EG000|Reported Event|Combination of Aliskiren and Enalapril|Aliskiren/Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg
10959905|NCT00853658|EG001|Reported Event|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
10959906|NCT00853658|EG002|Reported Event|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
10959907|NCT00853671|BG000|Baseline|Myocardial Stress CT Perfusion Imaging|Patients who will undergo myocardial stress CT perfusion imaging.
10959908|NCT00853671|FG000|Participant Flow|Myocardial Stress CT Perfusion Imaging|Patients who will undergo myocardial stress CT perfusion imaging. Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner)
10959909|NCT00853671|OG000|Outcome|Myocardial Stress CT Perfusion Imaging|Patients who will undergo myocardial stress CT perfusion imaging.
10959910|NCT00853671|EG000|Reported Event|Myocardial Stress CT Perfusion Imaging|Patients who will undergo myocardial stress CT perfusion imaging.
10959911|NCT00853723|BG000|Baseline|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
10959912|NCT00853723|BG001|Baseline|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
10959913|NCT00853723|BG002|Baseline|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
10959914|NCT00853723|BG003|Baseline|Total|Total of all reporting groups
10959915|NCT00853723|FG000|Participant Flow|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
10959916|NCT00853723|FG001|Participant Flow|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
10959917|NCT00853723|FG002|Participant Flow|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
10959918|NCT00853723|OG000|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
10959919|NCT00853723|OG001|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
10959920|NCT00853723|OG002|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
10959921|NCT00853723|OG000|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
10959922|NCT00853723|OG001|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
10959923|NCT00853723|OG002|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
10959924|NCT00853723|EG000|Reported Event|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
10959925|NCT00853723|EG001|Reported Event|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
10959926|NCT00853723|EG002|Reported Event|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
10963852|NCT00874549|OG003|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
10963853|NCT00874549|EG000|Reported Event|Menomune® Day 0|
10959927|NCT00853749|BG000|Baseline|PCV/23vPS/13vPnC|For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
10959928|NCT00853749|BG001|Baseline|PCV/PCV/13vPnC|For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
10959929|NCT00853749|BG002|Baseline|Total|Total of all reporting groups
10959930|NCT00853749|FG000|Participant Flow|PCV/23vPS/13vPnC|For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
10959931|NCT00853749|FG001|Participant Flow|PCV/PCV/13vPnC|For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
10959932|NCT00853749|OG000|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
10959933|NCT00853749|OG001|Outcome|PCV/PCV/13vPnC|For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
10959934|NCT00853749|EG000|Reported Event|PCV/23vPS/13vPnC|"For this study, participants received a single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).~Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9."
10959935|NCT00853749|EG001|Reported Event|PCV/PCV/13vPnC|"For this study, participants received a single 0.5 mL dose of 13vPnC, administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).~Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5."
10959936|NCT00853762|BG000|Baseline|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959937|NCT00853762|BG001|Baseline|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959938|NCT00853762|BG002|Baseline|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959939|NCT00853762|BG003|Baseline|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959940|NCT00853762|BG004|Baseline|Total|Total of all reporting groups
10959941|NCT00853762|FG000|Participant Flow|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959942|NCT00853762|FG001|Participant Flow|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959943|NCT00853762|FG002|Participant Flow|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959944|NCT00853762|FG003|Participant Flow|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959945|NCT00853762|OG000|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10963854|NCT00874549|EG001|Reported Event|Menactra® Day 0 x 2|
11179467|NCT02056431|OG001|Outcome|IVR Intervention Group|Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th,and 6th months post start date) to collect information on medication use, side effects, rating of side effects and pain symptoms to be fed back to their physicians
10959946|NCT00853762|OG001|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959947|NCT00853762|OG002|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959948|NCT00853762|OG003|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959949|NCT00853762|EG000|Reported Event|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959950|NCT00853762|EG001|Reported Event|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959951|NCT00853762|EG002|Reported Event|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959952|NCT00853762|EG003|Reported Event|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC as loading dose twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
10959953|NCT00853827|BG000|Baseline|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
10959954|NCT00853827|BG001|Baseline|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
10959955|NCT00853827|BG002|Baseline|Total|Total of all reporting groups
10959956|NCT00853827|FG000|Participant Flow|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
10959957|NCT00853827|FG001|Participant Flow|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
10959958|NCT00853827|OG000|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
10959959|NCT00853827|OG001|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
10959960|NCT00853827|EG000|Reported Event|Aliskiren 300 mg|Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
10959961|NCT00853827|EG001|Reported Event|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
10959962|NCT00853840|BG000|Baseline|All Subjects|In this 2-way crossover study, in Period 1, all 18 subjects were randomized to receive a single dose of either vardenafil 20 mg (Treatment A) or placebo (Treatment B), subsequent to treatment with 3 to 4 days of maraviroc 300 mg BID. All subjects were then crossed over to receive the second treatment in Period 2.
10959963|NCT00853840|FG000|Participant Flow|Vardenafil + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
10959964|NCT00853840|FG001|Participant Flow|Non-matching Placebo + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
10959965|NCT00853840|OG000|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
10959966|NCT00853840|OG001|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
10959967|NCT00853840|EG000|Reported Event|Maraviroc Run-In|All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B).
10959968|NCT00853840|EG001|Reported Event|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was to be taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
10959969|NCT00853840|EG002|Reported Event|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
10959970|NCT00853905|BG000|Baseline|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
10959971|NCT00853905|BG001|Baseline|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
10959972|NCT00853905|BG002|Baseline|Total|Total of all reporting groups
10959973|NCT00853905|FG000|Participant Flow|Treatment 1(Triesence)|"0.2cc Triesence~At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound."
11341780|NCT03688282|FG000|Participant Flow|Sham & 30 Minute Treatment|"Visit 1:~Device will be worn but not turned on. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.~Visit 2:~Device will be worn and turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips."
10959974|NCT00853905|FG001|Participant Flow|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique.~At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure."
10959975|NCT00853905|OG000|Outcome|Treatment 1(Triesence)|0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
10959976|NCT00853905|OG001|Outcome|Treatment 2 (Balanced Salt Solution BSS)|balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
10959977|NCT00853905|OG000|Outcome|Treatment 1(Triesence)|0.2cc Triesence At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
10959978|NCT00853905|OG000|Outcome|Triesence (Treatment 1)|0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
10959979|NCT00853905|OG001|Outcome|Balanced Salt Solution (BSS Treatment 2)|balanced salt solution (BSS) At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
10959980|NCT00853905|EG000|Reported Event|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
10959981|NCT00853905|EG001|Reported Event|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
10959982|NCT00853957|BG000|Baseline|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
10959983|NCT00853957|BG001|Baseline|Amlodipine|Amlodipine 5mg titrated to 10 mg
10959984|NCT00853957|BG002|Baseline|Total|Total of all reporting groups
10959985|NCT00853957|FG000|Participant Flow|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
10959986|NCT00853957|FG001|Participant Flow|Amlodipine|Amlodipine 5mg titrated to 10 mg
10959987|NCT00853957|OG000|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
10959988|NCT00853957|OG001|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
10959989|NCT00853957|EG000|Reported Event|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
10959990|NCT00853957|EG001|Reported Event|Amlodipine|Amlodipine 5mg titrated to 10 mg
10959991|NCT00853970|BG000|Baseline|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
10959992|NCT00853970|BG001|Baseline|Placebo|one drop daily in study eye for 2 weeks
10959993|NCT00853970|BG002|Baseline|Total|Total of all reporting groups
10959994|NCT00853970|FG000|Participant Flow|Bromfenac Ophthalmic Solution 0.09%|dosed 1 drop daily into the study eye for 2 weeks
10959995|NCT00853970|FG001|Participant Flow|Placebo|dosed 1 drop daily into the study eye for 2 weeks
10959996|NCT00853970|OG000|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
10959997|NCT00853970|OG001|Outcome|Placebo|one drop daily in study eye for 2 weeks
10959998|NCT00853970|EG000|Reported Event|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
10959999|NCT00853970|EG001|Reported Event|Placebo|one drop daily in study eye for 2 weeks
10960000|NCT00853996|BG000|Baseline|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
10960001|NCT00853996|FG000|Participant Flow|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
10960002|NCT00853996|OG000|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
10960003|NCT00853996|EG000|Reported Event|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
10960004|NCT00854061|BG000|Baseline|Overall|Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.
10960005|NCT00854061|FG000|Participant Flow|All Study Participants|"Participants received both treatment groups, one in each eye.~A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.~The investigator determined which eye was clinically suited for the first operative procedure (surgery); treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction."
10960006|NCT00854061|OG000|Outcome|T-Pred|"Tobramycin prednisolone acetate combination~T-Pred: sterile ophthalmic solution"
10960007|NCT00854061|OG001|Outcome|Pred Forte|"Prednisolone acetate~Pred Forte: sterile ophthalmic solution"
10960008|NCT00854061|EG000|Reported Event|T-Pred|
10960009|NCT00854061|EG001|Reported Event|Pred-Forte|
10960010|NCT00854087|BG000|Baseline|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
10960011|NCT00854087|BG001|Baseline|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
11341781|NCT03688282|OG000|Outcome|Sham Treatment Session|Device will be worn but not turned on (does not deliver the active treatment) for 30 minute treatment session.
10960012|NCT00854087|BG002|Baseline|Total|Total of all reporting groups
10960013|NCT00854087|FG000|Participant Flow|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
10960014|NCT00854087|FG001|Participant Flow|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
10960015|NCT00854087|OG000|Outcome|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
10960016|NCT00854087|OG001|Outcome|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
10960017|NCT00854087|EG000|Reported Event|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
10960018|NCT00854087|EG001|Reported Event|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
10960019|NCT00854100|BG000|Baseline|Placebo|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
10960020|NCT00854100|BG001|Baseline|Cariprazine 0.1 - 0.3 mg|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose
10960021|NCT00854100|BG002|Baseline|Cariprazine 1.0 - 2.0 mg|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
10960022|NCT00854100|BG003|Baseline|Total|Total of all reporting groups
10960023|NCT00854100|FG000|Participant Flow|Placebo|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
10960024|NCT00854100|FG001|Participant Flow|Cariprazine 0.1 - 0.3 mg|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose
10960025|NCT00854100|FG002|Participant Flow|Cariprazine 1.0 - 2.0 mg|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
10960026|NCT00854100|OG000|Outcome|Placebo|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
10960027|NCT00854100|OG001|Outcome|Cariprazine 0.1 - 0.3 mg|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose
10960028|NCT00854100|OG002|Outcome|Cariprazine 1.0 - 2.0 mg|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
10960029|NCT00854100|EG000|Reported Event|Prospective Antidepressant-Therapy Lead In Period|Interventions included: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) for 8 weeks prior to randomization
10960030|NCT00854100|EG001|Reported Event|Placebo|Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it.
10960031|NCT00854100|EG002|Reported Event|Cariprazine 0.1 - 0.3 mg|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it.
11341782|NCT03688282|OG001|Outcome|Active Treatment Session|Device will be worn and turned on (delivers the active treatment) for 30 minute treatment session.
10960032|NCT00854100|EG003|Reported Event|Cariprazine 1.0 - 2.0 mg|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it.
10960033|NCT00854113|BG000|Baseline|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
10960034|NCT00854113|BG001|Baseline|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
10960035|NCT00854113|BG002|Baseline|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
11179468|NCT02056431|EG000|Reported Event|IVR Intervention Group|"Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.~IVR Intervention Group: Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians."
11179469|NCT02056431|EG001|Reported Event|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
11179470|NCT02056626|BG000|Baseline|Partial Reinforcement|"partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)~carvedilol"
11179471|NCT02056626|BG001|Baseline|Controlled Dosing, Daily|"controlled dosing schedule 6.25 mg twice daily (15 days)~carvedilol"
11179472|NCT02056626|BG002|Baseline|Controlled Dosing, Every Other Day|"controlled dosing schedule 6.25 mg twice daily, every other day (15 days)~carvedilol"
11179473|NCT02056626|BG003|Baseline|Standard Therapy|"standard therapy, 25 mg twice daily (15 days)~carvedilol"
11179474|NCT02056626|BG004|Baseline|Total|Total of all reporting groups
11179475|NCT02056626|FG000|Participant Flow|Partial Reinforcement|"partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)~carvedilol"
11179476|NCT02056626|FG001|Participant Flow|Controlled Dosing, Daily|"controlled dosing schedule 6.25 mg twice daily (15 days)~carvedilol"
11179477|NCT02056626|FG002|Participant Flow|Controlled Dosing, Every Other Day|"controlled dosing schedule 6.25 mg twice daily, every other day (15 days)~carvedilol"
10960036|NCT00854113|BG003|Baseline|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
10960037|NCT00854113|BG004|Baseline|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
10960038|NCT00854113|BG005|Baseline|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
10960039|NCT00854113|BG006|Baseline|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
10960040|NCT00854113|BG007|Baseline|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
10960041|NCT00854113|BG008|Baseline|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
10960042|NCT00854113|BG009|Baseline|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
10960043|NCT00854113|BG010|Baseline|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
10960044|NCT00854113|BG011|Baseline|Total|Total of all reporting groups
10960045|NCT00854113|FG000|Participant Flow|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
10960046|NCT00854113|FG001|Participant Flow|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
10960047|NCT00854113|FG002|Participant Flow|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
10960048|NCT00854113|FG003|Participant Flow|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
10960049|NCT00854113|FG004|Participant Flow|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
10960050|NCT00854113|FG005|Participant Flow|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
10960051|NCT00854113|FG006|Participant Flow|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
10960052|NCT00854113|FG007|Participant Flow|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
11179478|NCT02056626|FG003|Participant Flow|Standard Therapy|"standard therapy, 25 mg twice daily (15 days)~carvedilol"
11179479|NCT02056626|OG000|Outcome|Partial Reinforcement|"partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)~carvedilol"
11179480|NCT02056626|OG001|Outcome|Controlled Dosing, Daily|"controlled dosing schedule 6.25 mg twice daily (15 days)~carvedilol"
11179481|NCT02056626|OG002|Outcome|Controlled Dosing, Every Other Day|"controlled dosing schedule 6.25 mg twice daily, every other day (15 days)~carvedilol"
11179482|NCT02056626|OG003|Outcome|Standard Therapy|"standard therapy, 25 mg twice daily (15 days)~carvedilol"
11179483|NCT02056626|EG000|Reported Event|Partial Reinforcement|"partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)~carvedilol"
11179484|NCT02056626|EG001|Reported Event|Controlled Dosing, Daily|"controlled dosing schedule 6.25 mg twice daily (15 days)~carvedilol"
11179485|NCT02056626|EG002|Reported Event|Controlled Dosing, Every Other Day|"controlled dosing schedule 6.25 mg twice daily, every other day (15 days)~carvedilol"
11179486|NCT02056626|EG003|Reported Event|Standard Therapy|"standard therapy, 25 mg twice daily (15 days)~carvedilol"
11341783|NCT03688282|EG000|Reported Event|Sham Treatment Session|Device will be worn but not turned on (does not deliver active treatment therapy) for the 30 minute treatment session.
10960053|NCT00854113|FG008|Participant Flow|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
10960054|NCT00854113|FG009|Participant Flow|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
10960055|NCT00854113|FG010|Participant Flow|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
10960056|NCT00854113|OG000|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
10960057|NCT00854113|OG001|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
10960058|NCT00854113|OG002|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
10960059|NCT00854113|OG003|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
10960060|NCT00854113|OG004|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
10960061|NCT00854113|OG005|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
10960062|NCT00854113|OG006|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
10960063|NCT00854113|OG007|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
10960064|NCT00854113|OG008|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
10960065|NCT00854113|OG009|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
10960066|NCT00854113|OG010|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
10960067|NCT00854113|EG000|Reported Event|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
10960068|NCT00854113|EG001|Reported Event|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
10960069|NCT00854113|EG002|Reported Event|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
10960070|NCT00854113|EG003|Reported Event|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
10960071|NCT00854113|EG004|Reported Event|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
10960072|NCT00854113|EG005|Reported Event|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
10960073|NCT00854113|EG006|Reported Event|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
10960074|NCT00854113|EG007|Reported Event|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
10960075|NCT00854113|EG008|Reported Event|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
10960076|NCT00854113|EG009|Reported Event|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
10960077|NCT00854113|EG010|Reported Event|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
10960078|NCT00854308|BG000|Baseline|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
10960079|NCT00854308|BG001|Baseline|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
10960080|NCT00854308|BG002|Baseline|Total|Total of all reporting groups
10960081|NCT00854308|FG000|Participant Flow|MetMAb + Erlotinib|MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
10960082|NCT00854308|FG001|Participant Flow|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
10960083|NCT00854308|OG000|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
10960084|NCT00854308|OG001|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
10960085|NCT00854308|EG000|Reported Event|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
10960086|NCT00854308|EG001|Reported Event|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
10960087|NCT00854360|BG000|Baseline|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
10960088|NCT00854360|BG001|Baseline|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
10960089|NCT00854360|BG002|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
10960090|NCT00854360|BG003|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
10960091|NCT00854360|BG004|Baseline|Total|Total of all reporting groups
10960092|NCT00854360|FG000|Participant Flow|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) and two actuations of placebo HFA once daily.
10960093|NCT00854360|FG001|Participant Flow|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
10960094|NCT00854360|FG002|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
11179487|NCT02056639|BG000|Baseline|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
10960095|NCT00854360|FG003|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
10960096|NCT00854360|OG000|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
10960097|NCT00854360|OG001|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
10960098|NCT00854360|OG002|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
10960099|NCT00854360|OG003|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
10960100|NCT00854360|EG000|Reported Event|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
10960101|NCT00854360|EG001|Reported Event|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
10960102|NCT00854360|EG002|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
10960103|NCT00854360|EG003|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
11179488|NCT02056639|BG001|Baseline|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
11179489|NCT02056639|BG002|Baseline|Total|Total of all reporting groups
11179490|NCT02056639|FG000|Participant Flow|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
11179491|NCT02056639|FG001|Participant Flow|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
10960104|NCT00854373|BG000|Baseline|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
10960105|NCT00854373|BG001|Baseline|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
10960106|NCT00854373|BG002|Baseline|Total|Total of all reporting groups
10960107|NCT00854373|FG000|Participant Flow|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
10960108|NCT00854373|FG001|Participant Flow|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
10960109|NCT00854373|OG000|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
10960110|NCT00854373|OG001|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
10960111|NCT00854373|EG000|Reported Event|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
10960112|NCT00854373|EG001|Reported Event|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
10960113|NCT00854581|BG000|Baseline|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
10960114|NCT00854581|FG000|Participant Flow|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
10960115|NCT00854581|OG000|Outcome|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
10960116|NCT00854581|OG000|Outcome|Part 2B Maintenance (Up to 12 Months)|"Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:~Zidovudine: 600 mg or 300 mg orally twice daily, per protocol~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol~Valproic acid, 250 mg orally twice daily, per protocol~Valproic Acid: Administered orally."
10960117|NCT00854581|OG000|Outcome|Induction (Up to Day 21)|"For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patients who achieve a PR will receive 7 more days of induction therapy and then go on to Part 1 Maintenance Therapy.:~Zidovudine:~Days 1-2: 1.5 grams intravenously (IV) twice daily~Days 3-21: 1.5 grams IV twice daily~Interferon alfa-2b (IFN):~5 10 million units (mu) intravenously twice daily~Interferon alfa-2b: Administered intravenously.~Zidovudine: Administered intravenously during Induction Therapy; orally during Maintenance Therapy in all Phases (1, 2A and 2B)."
10963855|NCT00874549|EG002|Reported Event|Menactra® Day 0 and Day 14|
11179492|NCT02056639|OG000|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
11179493|NCT02056639|OG001|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
11179494|NCT02056639|OG000|Outcome|Pessary|A biotec. pessary will be placed in subjects.
11179495|NCT02056639|OG001|Outcome|No Pessary|No pressary will be inserted and subjects will follow standard of care.
11179496|NCT02056639|EG000|Reported Event|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
10960118|NCT00854581|EG000|Reported Event|Induction Therapy|"For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patients who achieve a PR will receive 7 more days of induction therapy and then go on to Part 1 Maintenance Therapy.:~Zidovudine:~Days 1-2: 1.5 grams intravenously (IV) twice daily~Days 3-21: 1.5 grams IV twice daily~Interferon alfa-2b (IFN):~5 10 million units (mu) intravenously twice daily"
10960119|NCT00854581|EG001|Reported Event|Part 1 Maintenance|"From Treatment Day 14 or 21 to start of Month 3 (Day 60). Study participants move on to Part 1 Maintenance Therapy only if they achieve complete response (CR) or partial response (PR) after induction therapy. Restaging and molecular evaluation of disease at start of Month 3:~Zidovudine: 600 mg orally twice daily in all phases of Maintenance Therapy~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly~Participants then proceed to Part 2 maintenance."
10960120|NCT00854581|EG002|Reported Event|Part 2A Maintenance|"Participants achieving a CR with undetectable clonal disease. Participants will receive therapy for as long as response is maintained:~Zidovudine: 600 mg orally twice daily~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly"
10960121|NCT00854581|EG003|Reported Event|Part 2B Maintenance|"Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:~Zidovudine: 600 mg or 300 mg orally twice daily, per protocol~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol~Valproic acid, 250 mg orally twice daily, per protocol"
10960122|NCT00854594|BG000|Baseline|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
10960123|NCT00854594|BG001|Baseline|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
10960124|NCT00854594|BG002|Baseline|Total|Total of all reporting groups
10960125|NCT00854594|FG000|Participant Flow|Control|Providers within sites randomized to the control arm will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
10960126|NCT00854594|FG001|Participant Flow|ReSPECT Intervention|"Providers within sites randomized to the intervention arm will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention Community-Based Outpatient Clinics (CBOCs) by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
10960127|NCT00854594|OG000|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
10960128|NCT00854594|OG001|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
10960129|NCT00854594|EG000|Reported Event|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
10960130|NCT00854594|EG001|Reported Event|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
10960131|NCT00854607|BG000|Baseline|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
10960132|NCT00854607|FG000|Participant Flow|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven Invasive Aspergillosis (IA) infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
10963856|NCT00874549|EG003|Reported Event|Menactra® Day 0 and Day 28|
10960133|NCT00854607|OG000|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
10960134|NCT00854607|OG001|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 6.
10960135|NCT00854607|OG000|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
10960136|NCT00854607|OG001|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
10960137|NCT00854607|OG000|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
10960138|NCT00854607|OG001|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
10960139|NCT00854607|OG000|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
10960140|NCT00854607|OG001|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
10960141|NCT00854607|EG000|Reported Event|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, and were started on standard of care antifungal therapy.
10960142|NCT00854620|BG000|Baseline|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
10960143|NCT00854620|FG000|Participant Flow|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
10960144|NCT00854620|OG000|Outcome|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
10960145|NCT00854620|EG000|Reported Event|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
11179497|NCT02056639|EG001|Reported Event|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
10960146|NCT00854724|BG000|Baseline|Placebo, Then Puerarin|
10960147|NCT00854724|BG001|Baseline|Puerarin, Then Placebo|
10960148|NCT00854724|BG002|Baseline|Total|Total of all reporting groups
10960149|NCT00854724|FG000|Participant Flow|Placebo, Then Puerarin|
10960150|NCT00854724|FG001|Participant Flow|Puerarin, Then Placebo|
10960151|NCT00854724|OG000|Outcome|Placebo, Then Puerarin|
10960152|NCT00854724|OG001|Outcome|Puerarin, Then Placebo|
10960153|NCT00854724|EG000|Reported Event|Placebo, Then Puerarin|
10960154|NCT00854724|EG001|Reported Event|Puerarin, Then Placebo|
10960155|NCT00854828|BG000|Baseline|Randomized Cohort/Operative Intervention|Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis
10960156|NCT00854828|BG001|Baseline|Randomized Cohort/Non-Operative Intervention|Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
10960157|NCT00854828|BG002|Baseline|Observational Cohort/Operative Intervention|Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis
10960158|NCT00854828|BG003|Baseline|Observational Cohort/Non-Operative Intervention|Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
10960159|NCT00854828|BG004|Baseline|Total|Total of all reporting groups
10960160|NCT00854828|FG000|Participant Flow|Randomized Cohort/Operative Intervention|Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis.
11337334|NCT03582813|OG000|Outcome|Self-directed Care|"Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods..~Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system"
10960161|NCT00854828|FG001|Participant Flow|Randomized Cohort/Non-Operative Intervention|Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
10960162|NCT00854828|FG002|Participant Flow|Observational Cohort/Operative Intervention|Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis.
10960163|NCT00854828|FG003|Participant Flow|Observational Cohort/Non-Operative Intervention|Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
10960164|NCT00854828|OG000|Outcome|Randomized Surgical Intervention|Patients consenting to randomization and assigned to Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
10960165|NCT00854828|OG001|Outcome|Randomized Non-Operative Intervention|Patients consenting to randomization and assigned to Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
10960166|NCT00854828|OG000|Outcome|Observational Cohort Surgical Intervention|Patients consenting to Observational cohort participation, electively choosing Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
10960167|NCT00854828|OG001|Outcome|Observational Cohort Non-Operative Intervention|Patients consenting to Observational cohort participation, electively choosing Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
10960168|NCT00854828|OG000|Outcome|Randomized Cohort Surgical Intervention|Patients consenting to randomization and assigned to Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
10960169|NCT00854828|OG001|Outcome|Randomized Cohort Non-Operative Intervention|Patients consenting to randomization and assigned to Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
10960170|NCT00854828|EG000|Reported Event|Surgical Intervention-As Treated AE's Occurring While Patient Was in Surgical Arm|Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis. AE's are reported in the treatment arm (surgical or non-operative) patient was in at time of AE. A total of 171 patients had surgical intervention. This number includes non operative patients who crossed over to surgical intervention. Some patients spent time and had AEs in both treatment arms.
10960171|NCT00854828|EG001|Reported Event|Non-Operative Intervention-As Treated AE's Occurring While Patient Was on Non Operative Arm|Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. AE's are reported in the treatment arm (surgical or non-operative) patient was in at time of AE. A total of 150 had non operative interventions.
10960172|NCT00854906|BG000|Baseline|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). All study participants participated in both the KTBUT Study Arm and the FTBUT Study Arm.
10960173|NCT00854906|FG000|Participant Flow|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). Both KTBUT and FTBUT were measured in all study participants.
10960174|NCT00854906|OG000|Outcome|KTBUT|
10960175|NCT00854906|OG001|Outcome|FTBUT|
10960176|NCT00854906|OG000|Outcome|All Study Participants|
10960177|NCT00854906|EG000|Reported Event|KTBUT|
10960178|NCT00854906|EG001|Reported Event|FTBUT|
10960179|NCT00855010|BG000|Baseline|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23"
10960180|NCT00855010|BG001|Baseline|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19"
11179498|NCT02056652|BG000|Baseline|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
10960181|NCT00855010|BG002|Baseline|Total|Total of all reporting groups
10960182|NCT00855010|FG000|Participant Flow|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
10960183|NCT00855010|FG001|Participant Flow|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
10960184|NCT00855010|OG000|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
10960185|NCT00855010|OG001|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
11179499|NCT02056652|BG001|Baseline|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
10960186|NCT00855010|OG000|Outcome|Pioglitazone:|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily"
10960187|NCT00855010|OG001|Outcome|Placebo Pill:|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily"
10960188|NCT00855010|OG000|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily"
10960189|NCT00855010|OG001|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily"
10960190|NCT00855010|EG000|Reported Event|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
10960191|NCT00855010|EG001|Reported Event|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
10960192|NCT00855062|BG000|Baseline|Minocycline|Minocycline 100 mg orally every 12 hours
10960193|NCT00855062|BG001|Baseline|Placebo|Placebo minocycline capsules every 12 hours
10960194|NCT00855062|BG002|Baseline|Total|Total of all reporting groups
10960195|NCT00855062|FG000|Participant Flow|Minocycline|Minocycline 100 mg orally every 12 hours
10960196|NCT00855062|FG001|Participant Flow|Placebo|Placebo minocycline capsules every 12 hours
10960197|NCT00855062|OG000|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
10960198|NCT00855062|OG001|Outcome|Placebo|Placebo minocycline capsules every 12 hours
10960199|NCT00855062|EG000|Reported Event|Minocycline|Minocycline 100 mg orally every 12 hours
10960200|NCT00855062|EG001|Reported Event|Placebo|Placebo minocycline capsules every 12 hours
10960201|NCT00855166|BG000|Baseline|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
10960202|NCT00855166|BG001|Baseline|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
10960203|NCT00855166|BG002|Baseline|Total|Total of all reporting groups
10960204|NCT00855166|FG000|Participant Flow|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
10960205|NCT00855166|FG001|Participant Flow|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
10960206|NCT00855166|OG000|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
10960207|NCT00855166|OG001|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
10960208|NCT00855166|OG000|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
10960209|NCT00855166|OG001|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
11179500|NCT02056652|BG002|Baseline|Total|Total of all reporting groups
11179501|NCT02056652|FG000|Participant Flow|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
10960210|NCT00855166|EG000|Reported Event|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
10960211|NCT00855166|EG001|Reported Event|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
10960212|NCT00855218|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
10960213|NCT00855218|BG001|Baseline|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
10960214|NCT00855218|BG002|Baseline|Total|Total of all reporting groups
10960215|NCT00855218|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
10960216|NCT00855218|FG001|Participant Flow|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
10960217|NCT00855218|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
10960218|NCT00855218|OG001|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
10960219|NCT00855218|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
10960220|NCT00855218|EG001|Reported Event|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
10960221|NCT00855309|BG000|Baseline|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
10960222|NCT00855309|BG001|Baseline|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
11179502|NCT02056652|FG001|Participant Flow|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
11179503|NCT02056652|OG000|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
10960223|NCT00855309|BG002|Baseline|Total|Total of all reporting groups
10960224|NCT00855309|FG000|Participant Flow|Weight-based IV Acyclovir|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
10960225|NCT00855309|FG001|Participant Flow|Low-dose IV Acyclovir|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
10960226|NCT00855309|OG000|Outcome|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
10960227|NCT00855309|OG001|Outcome|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
10960228|NCT00855309|EG000|Reported Event|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
10960229|NCT00855309|EG001|Reported Event|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
10960230|NCT00855335|BG000|Baseline|Darunavir 600 mg /Ritonavir 100 mg Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
10960231|NCT00855335|BG001|Baseline|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
11179504|NCT02056652|OG001|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
10960232|NCT00855335|BG002|Baseline|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
10960233|NCT00855335|BG003|Baseline|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
10960234|NCT00855335|BG004|Baseline|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
10960235|NCT00855335|BG005|Baseline|Total|Total of all reporting groups
10960236|NCT00855335|FG000|Participant Flow|Darunavir 600 mg /Ritonavir 100 mg Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
10960237|NCT00855335|FG001|Participant Flow|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
10960238|NCT00855335|FG002|Participant Flow|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
10960239|NCT00855335|FG003|Participant Flow|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
10960240|NCT00855335|FG004|Participant Flow|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
10960241|NCT00855335|OG000|Outcome|Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
11179505|NCT02056652|EG000|Reported Event|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
11179506|NCT02056652|EG001|Reported Event|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
11179507|NCT02056834|BG000|Baseline|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
10960242|NCT00855335|OG001|Outcome|Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
10960243|NCT00855335|OG002|Outcome|Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
10960244|NCT00855335|OG003|Outcome|Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
10960245|NCT00855335|OG004|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
10960246|NCT00855335|OG005|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
10960247|NCT00855335|OG006|Outcome|Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
10960248|NCT00855335|OG007|Outcome|Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
10960249|NCT00855335|OG002|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
10960250|NCT00855335|OG000|Outcome|Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
10960251|NCT00855335|OG001|Outcome|Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
10960252|NCT00855335|OG002|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
10960253|NCT00855335|OG003|Outcome|Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
10960254|NCT00855335|OG004|Outcome|Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
10960255|NCT00855335|OG000|Outcome|Darunavir 600 mg /Ritonavir 100 Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
10960256|NCT00855335|OG001|Outcome|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
11179508|NCT02056834|FG000|Participant Flow|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
11179509|NCT02056834|OG000|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
11179510|NCT02056834|OG000|Outcome|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect~chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
10960257|NCT00855335|OG003|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
10960258|NCT00855335|OG004|Outcome|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
10960259|NCT00855335|EG000|Reported Event|Darunavir 600 mg /Ritonavir 100 mg Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
10960260|NCT00855335|EG001|Reported Event|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
10960261|NCT00855335|EG002|Reported Event|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
10960262|NCT00855335|EG003|Reported Event|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
10960263|NCT00855335|EG004|Reported Event|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
10960264|NCT00855413|BG000|Baseline|Acute HIV Infection Treatment Group|All participants were administered darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis and continued for 48 weeks. Participants were evaluated on study at weeks 2, 4, 8, 12, 16, 24 and 48.
10960265|NCT00855413|FG000|Participant Flow|Acute HIV Infection Treatment Group|All participants were administered darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis and continued for 48 weeks. Participants were evaluated on study at weeks 2, 4, 8, 12, 16, 24 and 48.
10960266|NCT00855413|OG000|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
10960267|NCT00855413|EG000|Reported Event|Darunavir/Ritonavir and Etravirine|"Darunavir/Ritonavir and Etravirine~DRV/r will be administered 800 mg/100 mg orally once daily.~ETR will be given 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen.~Darunavir/Ritonavir and Etravirine: DRV/r will be administered 800 mg/100 mg orally once daily.~ETR will be given 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen."
10960268|NCT00855439|BG000|Baseline|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
10960269|NCT00855439|BG001|Baseline|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
10960270|NCT00855439|BG002|Baseline|Total|Total of all reporting groups
10960271|NCT00855439|FG000|Participant Flow|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
10960272|NCT00855439|FG001|Participant Flow|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
10960273|NCT00855439|OG000|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
10960274|NCT00855439|OG001|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
10960275|NCT00855439|EG000|Reported Event|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
10960276|NCT00855439|EG001|Reported Event|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
10960277|NCT00855465|BG000|Baseline|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
10960278|NCT00855465|BG001|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
10960279|NCT00855465|BG002|Baseline|Total|Total of all reporting groups
10960280|NCT00855465|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
10960281|NCT00855465|FG001|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
11179511|NCT02056834|EG000|Reported Event|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect~chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
11341784|NCT03688282|EG001|Reported Event|Active Treatment Session|Device will be worn and turned on (delivers active treatment therapy) for the 30 minute treatment session.
10960282|NCT00855465|OG000|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
10960283|NCT00855465|OG001|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
10960284|NCT00855465|EG000|Reported Event|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
10960285|NCT00855465|EG001|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
10960286|NCT00855582|BG000|Baseline|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
10960287|NCT00855582|BG001|Baseline|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
11179512|NCT02057042|BG000|Baseline|Enhanced Usual Care|Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
11179513|NCT02057042|BG001|Baseline|PS-cCBT|Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
11179514|NCT02057042|BG002|Baseline|Total|Total of all reporting groups
11179515|NCT02057042|FG000|Participant Flow|Enhanced Usual Care|Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
11179516|NCT02057042|FG001|Participant Flow|PS-cCBT|Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
11179517|NCT02057042|OG000|Outcome|Enhanced Usual Care|Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
10960288|NCT00855582|BG002|Baseline|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
10960289|NCT00855582|BG003|Baseline|Total|Total of all reporting groups
10960290|NCT00855582|FG000|Participant Flow|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
10960291|NCT00855582|FG001|Participant Flow|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
10960292|NCT00855582|FG002|Participant Flow|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
10960293|NCT00855582|OG000|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
10960294|NCT00855582|OG001|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
10960295|NCT00855582|OG000|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
10960296|NCT00855582|OG000|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
10960297|NCT00855582|OG001|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
10960298|NCT00855582|OG002|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
10960299|NCT00855582|EG000|Reported Event|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
10960300|NCT00855582|EG001|Reported Event|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
10960301|NCT00855582|EG002|Reported Event|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
10960302|NCT00855595|BG000|Baseline|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
10960303|NCT00855595|BG001|Baseline|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
10960304|NCT00855595|BG002|Baseline|Total|Total of all reporting groups
10960305|NCT00855595|FG000|Participant Flow|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
10960306|NCT00855595|FG001|Participant Flow|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
10960307|NCT00855595|OG000|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
10960308|NCT00855595|OG001|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
10960309|NCT00855595|EG000|Reported Event|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks
10960310|NCT00855595|EG001|Reported Event|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks
10960311|NCT00855738|BG000|Baseline|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
11179518|NCT02057042|OG001|Outcome|PS-cCBT|Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
11179519|NCT02057042|EG000|Reported Event|Enhanced Usual Care|Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
11179520|NCT02057042|EG001|Reported Event|PS-cCBT|Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
11179521|NCT02057068|BG000|Baseline|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Six-Week Tele-Health Intervention~. Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Move Out time consisting of activity enhancement and exercise.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Stand Down time (meditation, therapeutic breathing and self-care).~. SLEEP-E Dyads book~. Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching~SLEEP-E Dyads Intervention: Described in arm/group description"
11179522|NCT02057068|BG001|Baseline|Usual Care Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
11179523|NCT02057068|BG002|Baseline|Total|Total of all reporting groups
11179524|NCT02057068|FG000|Participant Flow|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Intervention~Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching."
11179525|NCT02057068|FG001|Participant Flow|Wait List Control Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
11179526|NCT02057068|OG000|Outcome|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Intervention~Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching."
11179527|NCT02057068|OG001|Outcome|Wait List Control Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
11179528|NCT02057068|OG000|Outcome|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Six-Week Tele-Health Intervention~. Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Move Out time consisting of activity enhancement and exercise.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Stand Down time (meditation, therapeutic breathing and self-care).~. SLEEP-E Dyads book~. Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching~SLEEP-E Dyads Intervention: Described in arm/group description"
10960312|NCT00855738|FG000|Participant Flow|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
11179529|NCT02057068|OG001|Outcome|Usual Care Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
11179530|NCT02057068|EG000|Reported Event|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Intervention~Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching.~There were no adverse events."
11179531|NCT02057068|EG001|Reported Event|Wait List Control Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. There were no adverse events.
11179532|NCT02057081|BG000|Baseline|Treatment|"Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples.~Multifamily Group for mTBI for Couples: MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges."
10960313|NCT00855738|OG000|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
10960314|NCT00855738|OG000|Outcome|All Antiepileptic Drugs|
11179533|NCT02057081|BG001|Baseline|Control|"Didactic 14-session educational group intervention for families.~Group Health Education (GHE): GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas."
11179534|NCT02057081|BG002|Baseline|Total|Total of all reporting groups
11179535|NCT02057081|FG000|Participant Flow|Treatment|"Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples.~Multifamily Group for mTBI for Couples: MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges."
11179536|NCT02057081|FG001|Participant Flow|Control|"Didactic 14-session educational group intervention for families.~Group Health Education (GHE): GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas."
11179537|NCT02057081|OG000|Outcome|Treatment|"Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples.~Multifamily Group for mTBI for Couples: MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges."
11179538|NCT02057081|OG001|Outcome|Control|"Didactic 14-session educational group intervention for families.~Group Health Education (GHE): GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas."
11179539|NCT02057081|EG000|Reported Event|Treatment|"Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples.~Multifamily Group for mTBI for Couples: MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges."
11179540|NCT02057081|EG001|Reported Event|Control|"Didactic 14-session educational group intervention for families.~Group Health Education (GHE): GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas."
11179541|NCT02057198|BG000|Baseline|Fidaxomicin|"200 mg. 2 times a day for 10 days~Fidaxomicin"
11179542|NCT02057198|BG001|Baseline|Metronidazole|"500 mg.orally 3 times daily for 10 days~Metronidazole"
11179543|NCT02057198|BG002|Baseline|Vancomycin|"125 mg. orally 4 times a day for 10 days~Vancomycin"
11179544|NCT02057198|BG003|Baseline|Total|Total of all reporting groups
11179545|NCT02057198|FG000|Participant Flow|Fidaxomicin|"200 mg. 2 times a day for 10 days~Fidaxomicin"
11179546|NCT02057198|FG001|Participant Flow|Metronidazole|"500 mg.orally 3 times daily for 10 days~Metronidazole"
11179547|NCT02057198|FG002|Participant Flow|Vancomycin|"125 mg. orally 4 times a day for 10 days~Vancomycin"
11179548|NCT02057198|OG000|Outcome|Fidaxomicin|"200 mg. 2 times a day for 10 days~Fidaxomicin"
11179549|NCT02057198|OG001|Outcome|Metronidazole|"500 mg.orally 3 times daily for 10 days~Metronidazole"
11179550|NCT02057198|OG002|Outcome|Vancomycin|"125 mg. orally 4 times a day for 10 days~Vancomycin"
11179551|NCT02057198|EG000|Reported Event|Fidaxomicin|"200 mg. 2 times a day for 10 days~Fidaxomicin"
11179552|NCT02057198|EG001|Reported Event|Metronidazole|"500 mg.orally 3 times daily for 10 days~Metronidazole"
11179553|NCT02057198|EG002|Reported Event|Vancomycin|"125 mg. orally 4 times a day for 10 days~Vancomycin"
11179554|NCT02057250|BG000|Baseline|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
11179555|NCT02057250|BG001|Baseline|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
11179556|NCT02057250|BG002|Baseline|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
11179557|NCT02057250|BG003|Baseline|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
11179558|NCT02057250|BG004|Baseline|Total|Total of all reporting groups
11179559|NCT02057250|FG000|Participant Flow|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) for 12 weeks.
11179560|NCT02057250|FG001|Participant Flow|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
11179561|NCT02057250|FG002|Participant Flow|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
11179562|NCT02057250|FG003|Participant Flow|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
11179563|NCT02057250|FG004|Participant Flow|Sarilumab 150 mg by PFS (Extension Phase)|Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
11179564|NCT02057250|OG000|Outcome|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
11179565|NCT02057250|OG001|Outcome|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
11179566|NCT02057250|OG001|Outcome|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
10960315|NCT00855738|EG000|Reported Event|All Antiepileptic Drugs (Including Pregabalin)|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin
10960316|NCT00855738|EG001|Reported Event|Pregabalin (Pregabalin Only)|
10963857|NCT00874614|BG000|Baseline|AZEDRA® (Iobenguane I 131)|Patients received dosimetric dose (~5 mCi) of AZEDRA® via intravenous injection to confirm iobenguane-avidity and to establish dosimetry and biodistribution assessment. Eligible patients received a therapeutic dose of AZEDRA® based on body weight and reduced, if necessary, based on the dosimetry data. The second therapeutic dose is administered intravenously at least 90 days later.
10963858|NCT00874614|FG000|Participant Flow|AZEDRA® (Iobenguane I 131)|Patients received dosimetric dose (~5 mCi) of AZEDRA® via intravenous injection to confirm iobenguane-avidity and to establish dosimetry and biodistribution assessment. Eligible patients received a therapeutic dose of AZEDRA® based on body weight and reduced, if necessary, based on the dosimetry data. The second therapeutic dose is administered intravenously at least 90 days later.
11179567|NCT02057250|OG002|Outcome|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
11179568|NCT02057250|OG003|Outcome|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
11179569|NCT02057250|EG000|Reported Event|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
11179570|NCT02057250|EG001|Reported Event|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
11179571|NCT02057250|EG002|Reported Event|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
11179572|NCT02057250|EG003|Reported Event|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
11179573|NCT02057250|EG004|Reported Event|Sarilumab 150 mg by PFS (Extension Phase)|Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
11179574|NCT02057393|BG000|Baseline|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
10963859|NCT00874614|OG000|Outcome|AZEDRA® (Iobenguane I 131)|Patients received at least one therapeutic dose of AZEDRA®.
11179575|NCT02057393|FG000|Participant Flow|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
11240763|NCT02481596|FG000|Participant Flow|REACH + FAMS|"Participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months.~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages."
10963860|NCT00874614|OG000|Outcome|At Least One Therapeutic Dose of AZEDRA®|Patients received at least one therapeutic dose of AZEDRA®.
10963861|NCT00874614|OG001|Outcome|Two Therapeutic Doses of AZEDRA®|Patients received two therapeutic doses of AZEDRA®.
10963862|NCT00874614|EG000|Reported Event|AZEDRA® (Iobenguane I 131)|Patients who received any dose of AZEDRA® (N=74). All-cause mortality was followed in patients who received at least one therapeutic dose of AZEDRA® (N=68), up through long-term follow-up as of December 2017.
10963863|NCT00874731|BG000|Baseline|Pt 1, Day 1. Placebo|[Pt 1, Day 1]: Participants received a single dose of placebo (10 oral tablets) on Day 1 of Part 1.
10963864|NCT00874731|FG000|Participant Flow|Pt 1, Day 1. Placebo|[Pt 1, Day 1]: Participants received a single dose of placebo (10 oral tablets) on Day 1 of Part 1.
10963865|NCT00874731|FG001|Participant Flow|Pt 1, Day 2. Ridaforolimus 100 mg|[Pt 1, Day 2]: Following completion of Part 1 / Day 1, participants received a single dose of ridaforolimus 100 mg (10 x 10 mg oral tablets) on Day 2 of Part 1. Following completion of Part 1 / Day 2, participants entered a washout period of ≥5 days before the first dose Part 2.
10963866|NCT00874731|FG002|Participant Flow|Pt 2. Ridaforolimus 40 mg|[Pt 2]: Following completion of Part 1, participants received ridaforolimus 40 mg (4 x 10 mg oral tablets) given once daily (QD) for 5 consecutive days followed by 2 days off-drug.
10963867|NCT00874731|OG000|Outcome|Pt 1, Day 1. Placebo|[Pt 1, Day 1]: Participants received a single dose of placebo (10 oral tablets) on Day 1 of Part 1.
10963868|NCT00874731|OG001|Outcome|Pt 1, Day 2. Ridaforolimus 100 mg|[Pt 1, Day 2]: Following completion of Part 1 / Day 1, participants received a single dose of ridaforolimus 100 mg (10 x 10 mg oral tablets) on Day 2 of Part 1. Following completion of Part 1 / Day 2, participants entered a washout period of ≥5 days before the first dose Part 2.
10960317|NCT00855816|BG000|Baseline|Breathing Training|relaxation training
10960318|NCT00855816|BG001|Baseline|Treatment as Usual|No intervention: Treatment as usual
10960319|NCT00855816|BG002|Baseline|Total|Total of all reporting groups
10960320|NCT00855816|FG000|Participant Flow|Breathing Training|relaxation training
10960321|NCT00855816|FG001|Participant Flow|Treatment as Usual|No intervention - treatment as usual
10960322|NCT00855816|OG000|Outcome|Breathing Training|relaxation training
10960323|NCT00855816|OG001|Outcome|Treatment as Usual|No intervention: treatment as usual
10960324|NCT00855816|EG000|Reported Event|Breathing Training|relaxation training
10960325|NCT00855816|EG001|Reported Event|Treatment as Usual|No intervention: Treatment as usual
10960326|NCT00855842|BG000|Baseline|Osmotic Dilator|osmotic dilator
10960327|NCT00855842|FG000|Participant Flow|Osmotic Dilator|osmotic dilator
10960328|NCT00855842|OG000|Outcome|Osmotic Dilator|osmotic dilator
10960329|NCT00855842|EG000|Reported Event|Osmotic Dilator|osmotic dilator
11337335|NCT03582813|OG001|Outcome|Services as Usual|"Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers.~Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency"
10960330|NCT00855868|BG000|Baseline|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
10960331|NCT00855868|BG001|Baseline|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
10960332|NCT00855868|BG002|Baseline|Total|Total of all reporting groups
10960333|NCT00855868|FG000|Participant Flow|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
10960334|NCT00855868|FG001|Participant Flow|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
10960335|NCT00855868|OG000|Outcome|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
10960336|NCT00855868|OG001|Outcome|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
10960337|NCT00855868|EG000|Reported Event|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
10960338|NCT00855868|EG001|Reported Event|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
10960339|NCT00855894|BG000|Baseline|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
10960340|NCT00855894|FG000|Participant Flow|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
10960341|NCT00855894|OG000|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
10960342|NCT00855894|EG000|Reported Event|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
10960343|NCT00855920|BG000|Baseline|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
10960344|NCT00855920|BG001|Baseline|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
10960345|NCT00855920|BG002|Baseline|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
10960346|NCT00855920|BG003|Baseline|Total|Total of all reporting groups
10960347|NCT00855920|FG000|Participant Flow|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
10960348|NCT00855920|FG001|Participant Flow|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
10960349|NCT00855920|FG002|Participant Flow|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
10960350|NCT00855920|OG000|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
10960351|NCT00855920|OG001|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
10960352|NCT00855920|OG002|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
10960353|NCT00855920|EG000|Reported Event|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in this arm.
10960354|NCT00855920|EG001|Reported Event|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in arm (Placebo [for Rilonacept] and Indomethacin).
10960355|NCT00855920|EG002|Reported Event|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
10960356|NCT00855933|BG000|Baseline|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
10960357|NCT00855933|BG001|Baseline|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
10960358|NCT00855933|BG002|Baseline|Total|Total of all reporting groups
10960359|NCT00855933|FG000|Participant Flow|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
10960360|NCT00855933|FG001|Participant Flow|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
10960361|NCT00855933|OG000|Outcome|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
10960362|NCT00855933|OG001|Outcome|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
10960363|NCT00855933|EG000|Reported Event|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
10960364|NCT00855933|EG001|Reported Event|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
10960365|NCT00855959|BG000|Baseline|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
10960366|NCT00855959|FG000|Participant Flow|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
10960367|NCT00855959|OG000|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
10960368|NCT00855959|EG000|Reported Event|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
10960369|NCT00856024|BG000|Baseline|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
10960370|NCT00856024|FG000|Participant Flow|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
10960371|NCT00856024|OG000|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
10960372|NCT00856024|OG001|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
10960373|NCT00856024|OG002|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
10960374|NCT00856024|EG000|Reported Event|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
10960375|NCT00856050|BG000|Baseline|Letrozole|letrozole 2.5mg by mouth per day
10960376|NCT00856050|FG000|Participant Flow|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
10960377|NCT00856050|OG000|Outcome|Letrozole|letrozole 2.5mg by mouth per day
10960378|NCT00856050|EG000|Reported Event|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
10963869|NCT00874731|OG002|Outcome|Pt 2. Ridaforolimus 40 mg|[Pt 2]: Following completion of Part 1, participants received ridaforolimus 40 mg (4 x 10 mg oral tablets) given once daily (QD) for 5 consecutive days followed by 2 days off-drug.
10963870|NCT00874731|EG000|Reported Event|Pt 1, Day 1. Placebo|[Pt 1, Day 1]: Participants received a single dose of placebo (10 oral tablets) on Day 1 of Part 1.
10960379|NCT00856180|BG000|Baseline|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
10960380|NCT00856180|FG000|Participant Flow|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
10960381|NCT00856180|OG000|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
10960382|NCT00856180|OG000|Outcome|Platinum Sensitive|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum sensitive is defined as having had a >6 month interval since last receiving platinum therapy prior to disease recurrence.
11179576|NCT02057393|OG000|Outcome|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
11179577|NCT02057393|EG000|Reported Event|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
11179578|NCT02057406|BG000|Baseline|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
11179579|NCT02057406|BG001|Baseline|High EPA|"Almost pure EPA 2 grams~High EPA"
11179580|NCT02057406|BG002|Baseline|Placebo|"Matched placebo corn oil capsules~Placebo"
11179581|NCT02057406|BG003|Baseline|Total|Total of all reporting groups
11179582|NCT02057406|FG000|Participant Flow|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid (DHA) fish oil 2 grams"
11179583|NCT02057406|FG001|Participant Flow|High EPA|"Almost pure EPA 2 grams~High EPA"
11179584|NCT02057406|FG002|Participant Flow|Placebo|"Matched placebo corn oil capsules~Placebo"
11179585|NCT02057406|OG000|Outcome|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
11179586|NCT02057406|OG001|Outcome|High EPA|"Almost pure EPA 2 grams~High EPA"
11179587|NCT02057406|OG002|Outcome|Placebo|"Matched placebo corn oil capsules~Placebo"
10960383|NCT00856180|OG001|Outcome|Platinum Resistant|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a </=6 month interval since last receiving platinum therapy prior to disease recurrence.
10960384|NCT00856180|EG000|Reported Event|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
10960385|NCT00856193|BG000|Baseline|All Randomized Patients|NVA237 50 μg capsules for inhalation once daily with Concept 1 device. Matching placebo 50 µg capsules for inhalation once daily with Concept 1 device.
11179588|NCT02057406|EG000|Reported Event|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
11179589|NCT02057406|EG001|Reported Event|High EPA|"Almost pure EPA 2 grams~High EPA"
11179590|NCT02057406|EG002|Reported Event|Placebo|"Matched placebo corn oil capsules~Placebo"
11179591|NCT02057458|BG000|Baseline|Overall Study|Baseline characteristics reported for the overall study
11179592|NCT02057458|FG000|Participant Flow|Acute Study: Sildenafil First, Then Placebo|In randomized order, on two separate days, endothelial function and exercise capacity will be determined 1 hour following a single dose of sildenafil (50 mg) or placebo.
11179593|NCT02057458|FG001|Participant Flow|Acute Study: Placebo First, Then Sildenafil|In randomized order, on two separate days, endothelial function and exercise capacity will be determined 1 hour following a single dose of sildenafil (50 mg) or placebo.
11179594|NCT02057458|FG002|Participant Flow|Sub-Chronic Only|participants who were unable to participate in the acute study due to distance from lab but participated in sub-chronic
10960386|NCT00856193|FG000|Participant Flow|NVA237 50μg Then Placebo|NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
10960387|NCT00856193|FG001|Participant Flow|Placebo Then NVA237 50μg|Placebo 50 µg capsules followed by NVA237 50 µg capsules for inhalation once daily with Concept 1 device.
10960388|NCT00856193|OG000|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
10960389|NCT00856193|OG001|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
10960390|NCT00856193|EG000|Reported Event|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
10960391|NCT00856193|EG001|Reported Event|NVA237 50 μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
10960392|NCT00856206|BG000|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
10960393|NCT00856206|BG001|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
11179595|NCT02057458|OG000|Outcome|Acute Study: Sildenafil|FMD % after acute sildenafil treatment
11179596|NCT02057458|OG001|Outcome|Acute Study: Placebo|FMD % after acute placebo
10960394|NCT00856206|BG002|Baseline|Total|Total of all reporting groups
10960395|NCT00856206|FG000|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
10960396|NCT00856206|FG001|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10960397|NCT00856206|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
10960398|NCT00856206|OG001|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
11179597|NCT02057458|OG000|Outcome|Baseline|"Baseline artery diameter during FMD taken on preliminary visit before having any treatment."
11179598|NCT02057458|OG001|Outcome|Sub-chronic Study: Sildenafil|Baseline artery diameter during FMD after sub-chronic (4 weeks) sildenafil treatment
10960399|NCT00856206|EG000|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
10960400|NCT00856206|EG001|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
10960401|NCT00856232|BG000|Baseline|Standard Therapy|Standard emergency department evaluation and treatment for headache
10960402|NCT00856232|BG001|Baseline|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
10960403|NCT00856232|BG002|Baseline|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
10960404|NCT00856232|BG003|Baseline|Total|Total of all reporting groups
10960405|NCT00856232|FG000|Participant Flow|Standard Therapy|Standard emergency department evaluation and treatment for headache
11179599|NCT02057458|OG000|Outcome|Baseline|Peak artery diameter during FMD taken on preliminary visit before having any treatment.
10960406|NCT00856232|FG001|Participant Flow|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
10960407|NCT00856232|FG002|Participant Flow|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
10960408|NCT00856232|OG000|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
10960409|NCT00856232|OG001|Outcome|Medical Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
10960410|NCT00856232|OG002|Outcome|Oxygen at 15 L / Min|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
10960411|NCT00856232|OG001|Outcome|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
10960412|NCT00856232|OG002|Outcome|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
10960413|NCT00856232|EG000|Reported Event|Standard Therapy|Standard emergency department evaluation and treatment for headache
10960414|NCT00856232|EG001|Reported Event|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
10960415|NCT00856232|EG002|Reported Event|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
10960416|NCT00856245|BG000|Baseline|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
11179600|NCT02057458|OG001|Outcome|Sub-chronic Study: Sildenafil|Peak artery diameter during FMD after sub-chronic (4 weeks) sildenafil treatment
11179601|NCT02057458|OG000|Outcome|Baseline|Absolute change in artery diameter during FMD taken on preliminary visit before having any treatment.
11179602|NCT02057458|OG001|Outcome|Sub-chronic Study: Sildenafil|Absolute change in artery diameter during FMD after sub-chronic (4 weeks) sildenafil treatment
11179603|NCT02057458|OG000|Outcome|Baseline|Baseline measures taken on preliminary visit before having any treatment.
11179604|NCT02057458|OG001|Outcome|Acute Study: Sildenafil|FEV1 %predicted after acute sildenafil treatment
11179605|NCT02057458|OG002|Outcome|Acute Study: Placebo|FEV1 %predicted after acute placebo
11179606|NCT02057458|OG003|Outcome|Sub-chronic Study: Sildenafil|FEV1 %predicted after sub-chronic (4 weeks) sildenafil treatment
11179607|NCT02057458|OG001|Outcome|Acute Study: Sildenafil|absolute VO2 peak after acute sildenafil treatment
11179608|NCT02057458|OG002|Outcome|Acute Study: Placebo|absolute VO2 peak after acute placebo
10960417|NCT00856245|FG000|Participant Flow|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
10960418|NCT00856245|OG000|Outcome|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
10960419|NCT00856245|EG000|Reported Event|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
11179609|NCT02057458|OG003|Outcome|Sub-chronic Study: Sildenafil|absolute VO2 peak after sub-chronic (4 weeks) sildenafil treatment
11179610|NCT02057458|OG001|Outcome|Acute Study: Sildenafil|relative VO2 peak after acute sildenafil treatment
11179611|NCT02057458|OG002|Outcome|Acute Study: Placebo|relative VO2 peak after acute placebo
11179612|NCT02057458|OG003|Outcome|Sub-chronic Study: Sildenafil|relative VO2 peak after sub-chronic (4 weeks) sildenafil treatment
11179613|NCT02057458|OG001|Outcome|Acute Study: Sildenafil|VO2 peak %predicted after acute sildenafil treatment
11179614|NCT02057458|OG002|Outcome|Acute Study: Placebo|VO2 peak %predicted after acute placebo
11179615|NCT02057458|OG003|Outcome|Sub-chronic Study: Sildenafil|VO2 peak %predicted after sub-chronic (4 weeks) sildenafil treatment
11179616|NCT02057458|OG001|Outcome|Acute Study: Sildenafil|VE peak after acute sildenafil treatment
11179617|NCT02057458|OG002|Outcome|Acute Study: Placebo|VE peak after acute placebo
11179618|NCT02057458|OG003|Outcome|Sub-chronic Study: Sildenafil|VE peak after sub-chronic (4 weeks) sildenafil treatment
11179619|NCT02057458|OG001|Outcome|Acute Study: Sildenafil|RER peak after acute sildenafil treatment
11179620|NCT02057458|OG002|Outcome|Acute Study: Placebo|RER peak after acute placebo
11179621|NCT02057458|OG003|Outcome|Sub-chronic Study: Sildenafil|RER peak after sub-chronic (4 weeks) sildenafil treatment
11179622|NCT02057458|EG000|Reported Event|Overall Study|Overall Study
11179623|NCT02057523|BG000|Baseline|Acthar|"Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.~Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months."
10960420|NCT00856284|BG000|Baseline|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
10960421|NCT00856284|BG001|Baseline|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
11179624|NCT02057523|FG000|Participant Flow|Acthar|"Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.~Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months."
11179625|NCT02057523|OG000|Outcome|Acthar|"Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.~Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months."
11179626|NCT02057523|EG000|Reported Event|Acthar|"Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.~Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months."
11179627|NCT02057549|BG000|Baseline|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
11179628|NCT02057549|BG001|Baseline|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
11179629|NCT02057549|BG002|Baseline|Total|Total of all reporting groups
11179630|NCT02057549|FG000|Participant Flow|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
11179631|NCT02057549|FG001|Participant Flow|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
10960422|NCT00856284|BG002|Baseline|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
10960423|NCT00856284|BG003|Baseline|Total|Total of all reporting groups
10960424|NCT00856284|FG000|Participant Flow|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
10960425|NCT00856284|FG001|Participant Flow|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
10960426|NCT00856284|FG002|Participant Flow|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
10960427|NCT00856284|OG000|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
10960428|NCT00856284|OG001|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
10960429|NCT00856284|OG002|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
10960430|NCT00856284|EG000|Reported Event|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
10960431|NCT00856284|EG001|Reported Event|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
10960432|NCT00856284|EG002|Reported Event|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
10960433|NCT00856297|BG000|Baseline|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
10960434|NCT00856297|BG001|Baseline|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
10960435|NCT00856297|BG002|Baseline|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
10960436|NCT00856297|BG003|Baseline|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
10960437|NCT00856297|BG004|Baseline|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
10960438|NCT00856297|BG005|Baseline|Total|Total of all reporting groups
10960439|NCT00856297|FG000|Participant Flow|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
10960440|NCT00856297|FG001|Participant Flow|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
10960441|NCT00856297|FG002|Participant Flow|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
10960442|NCT00856297|FG003|Participant Flow|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
10960443|NCT00856297|FG004|Participant Flow|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
10960444|NCT00856297|OG000|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
10960445|NCT00856297|OG001|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
10960446|NCT00856297|OG000|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
10960447|NCT00856297|OG000|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
10960448|NCT00856297|OG001|Outcome|Licensed Comparator/MenACWY-CRM|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study, and one booster dose of MenACWY- CRM conjugate vaccine in the present study at 3 years after primary vaccination.
10960449|NCT00856297|OG001|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
10960450|NCT00856297|OG001|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination..
10960451|NCT00856297|OG002|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
10960452|NCT00856297|OG003|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
10960453|NCT00856297|OG002|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
10960454|NCT00856297|EG000|Reported Event|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
10960455|NCT00856297|EG001|Reported Event|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
10960456|NCT00856297|EG002|Reported Event|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
10960457|NCT00856297|EG003|Reported Event|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
10960458|NCT00856297|EG004|Reported Event|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
10960459|NCT00856323|BG000|Baseline|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
10960460|NCT00856323|FG000|Participant Flow|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
10960461|NCT00856323|OG000|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
10960462|NCT00856323|EG000|Reported Event|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
10960463|NCT00856349|BG000|Baseline|Analysis Cohort|"Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.~Therapy Programming Report (TPR): Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study."
10960464|NCT00856349|FG000|Participant Flow|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.
10960465|NCT00856349|OG000|Outcome|Subjects With Paired Programming Data|Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
10960466|NCT00856349|OG000|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
10960467|NCT00856349|OG000|Outcome|Subjects With Final Programming Data Available|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.
10960468|NCT00856349|EG000|Reported Event|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
10960469|NCT00856375|BG000|Baseline|NKTR-102|"NKTR-102~NKTR-102: IV every 3 weeks"
10960470|NCT00856375|BG001|Baseline|Irinotecan|"IV every 3 weeks~irinotecan: IV every 3 weeks"
10960471|NCT00856375|BG002|Baseline|Total|Total of all reporting groups
10960472|NCT00856375|FG000|Participant Flow|NKTR-102|NKTR-102 was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle at a dose level of 145 mg/m^2.
10960473|NCT00856375|FG001|Participant Flow|Irinotecan|Irinotecan was administered as an IV infusion on Day 1 of a 21-day treatment cycle at a dose level of 350 mg/m^2. Patients aged 65 or older, or those with prior abdominal or pelvic irradiation, were given a lower dose of 300 mg/m^2.
10960474|NCT00856375|OG000|Outcome|NKTR-102|NKTR-102 IV every 3 weeks
10960475|NCT00856375|OG001|Outcome|Irinotecan|irinotecan IV every 3 weeks
10960476|NCT00856375|EG000|Reported Event|NKTR-102|NKTR-102 IV every 3 weeks
10960477|NCT00856375|EG001|Reported Event|Irinotecan|irinotecan IV every 3 weeks
10960478|NCT00856388|BG000|Baseline|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
10960479|NCT00856388|FG000|Participant Flow|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
10960480|NCT00856388|OG000|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
10960481|NCT00856388|OG000|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo total-body irradiation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~anti-thymocyte globulin: Given IV"
10960482|NCT00856388|EG000|Reported Event|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo total-body irradiation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~anti-thymocyte globulin: Given IV"
10960483|NCT00856414|BG000|Baseline|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
10960484|NCT00856414|FG000|Participant Flow|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
10960485|NCT00856414|OG000|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
10960486|NCT00856414|EG000|Reported Event|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
11179632|NCT02057549|OG000|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
11179633|NCT02057549|OG001|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
10960487|NCT00856492|BG000|Baseline|Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
10960488|NCT00856492|BG001|Baseline|Arm 2 (Nab-Paclitaxel / AC+PEG-G))|Received nP x 12 followed by ddAC x 6 without bevacizumab
10960489|NCT00856492|BG002|Baseline|Arm 3 (AC+PEG-G / Nab-Paclitaxel)|Received ddAC x 6 first followed by nP x 12, without bevacizumab
10960490|NCT00856492|BG003|Baseline|Total|Total of all reporting groups
10960491|NCT00856492|FG000|Participant Flow|Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
10960492|NCT00856492|FG001|Participant Flow|Arm 2 (Nab-Paclitaxel / AC+PEG-G)|Received nP x 12 without bevacizumab followed by ddAC x 6
10960493|NCT00856492|FG002|Participant Flow|Arm 3 (AC+PEG-G / Nab-Paclitaxel)|ddAC x 6 followed by nP x 12 without bevacizumab
10960494|NCT00856492|OG000|Outcome|Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
10960495|NCT00856492|OG001|Outcome|Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))|Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
10960496|NCT00856492|OG001|Outcome|Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))|Arm II received nP x 12 followed by ddAC x 6, and those randomized to Arm III received ddAC x 6 first followed by nP x 12, both without bevacizumab
10960497|NCT00856492|OG000|Outcome|Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
10960498|NCT00856492|OG001|Outcome|Arm II (Nab-Paclitaxel - AC+PEG-G)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
10960499|NCT00856492|OG002|Outcome|Arm III (AC+PEG-G - Nab-Paclitaxel)|Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
10960500|NCT00856492|EG000|Reported Event|Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
10960501|NCT00856492|EG001|Reported Event|Arm II (Nab-Paclitaxel - AC+PEG-G)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
10960502|NCT00856492|EG002|Reported Event|Arm III (AC+PEG-G - Nab-Paclitaxel)|Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
10960503|NCT00856518|BG000|Baseline|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
10960504|NCT00856518|BG001|Baseline|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
10960505|NCT00856518|BG002|Baseline|Total|Total of all reporting groups
10960506|NCT00856518|FG000|Participant Flow|Arm 1: EMST|"Experimental Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
10960507|NCT00856518|FG001|Participant Flow|Arm 2: Sham Group|"sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
10960508|NCT00856518|OG000|Outcome|Arm 1: EMST|"EMST Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
10960509|NCT00856518|OG001|Outcome|Arm 2: Sham|"Sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
10960510|NCT00856518|OG000|Outcome|Arm 1: EMST|"The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
10960511|NCT00856518|OG001|Outcome|Arm 2: Sham Group|"The sham group undergoes the same 5-week EMST exercise as the experimental group using the same device but without a spring for minimal pressure load~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
10960512|NCT00856518|EG000|Reported Event|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
10960513|NCT00856518|EG001|Reported Event|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
10960514|NCT00856544|BG000|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
10960515|NCT00856544|BG001|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
10960516|NCT00856544|BG002|Baseline|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
10960517|NCT00856544|BG003|Baseline|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
10960518|NCT00856544|BG004|Baseline|Total|Total of all reporting groups
10960519|NCT00856544|FG000|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
10960520|NCT00856544|FG001|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
10960521|NCT00856544|FG002|Participant Flow|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
10960522|NCT00856544|FG003|Participant Flow|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
10960523|NCT00856544|OG000|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
10960524|NCT00856544|OG001|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
10960525|NCT00856544|OG002|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
10960526|NCT00856544|OG002|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
10960527|NCT00856544|OG002|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
10960528|NCT00856544|OG003|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
10960529|NCT00856544|OG002|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
10960530|NCT00856544|OG003|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
10960531|NCT00856544|EG000|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg Film-coated tablet administered orally twice daily up to Month 3.
10960532|NCT00856544|EG001|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg Film-coated tablet administered orally twice daily up to Month 3.
10960533|NCT00856544|EG002|Reported Event|Placebo (Up To Month 3)|Matching placebo Film-coated tablet orally twice daily up to Month 3.
10960534|NCT00856544|EG003|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg twice daily from Month 3 to 6.
11357671|NCT03750695|BG000|Baseline|All Study Participants|"Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise~Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)~Rest: 40 minutes of quiet rest in semi-recumbent position"
10960535|NCT00856544|EG004|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet twice daily from Month 3 to 6.
10960536|NCT00856544|EG005|Reported Event|Placebo (Month 3 to 6)|Matching placebo twice daily from Month 3 to 6.
10960537|NCT00856544|EG006|Reported Event|Placebo, Then CP-690,550 5 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 5 mg tablet twice daily from Month 3 to 6.
10960538|NCT00856544|EG007|Reported Event|Placebo, Then CP-690,550 10 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 10 mg tablet twice daily from Month 3 to 6.
10960539|NCT00856544|EG008|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
10960540|NCT00856544|EG009|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily from Month 6 to 12.
10960541|NCT00856544|EG010|Reported Event|Placebo, Then CP-690,550 5 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 5 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 5 mg tablet twice daily from Month 6 to 12.
10960542|NCT00856544|EG011|Reported Event|Placebo, Then CP-690,550 10 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 10 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 10 mg tablet twice daily from Month 6 to 12.
10960543|NCT00856557|BG000|Baseline|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
10960544|NCT00856557|BG001|Baseline|No Intervention|No educational intervention
10960545|NCT00856557|BG002|Baseline|Total|Total of all reporting groups
10960546|NCT00856557|FG000|Participant Flow|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
10960547|NCT00856557|FG001|Participant Flow|No Intervention|No educational intervention
10960548|NCT00856557|OG000|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
10960549|NCT00856557|OG001|Outcome|No Intervention|No educational intervention
10960550|NCT00856557|EG000|Reported Event|Seminar and Practium|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
10960551|NCT00856557|EG001|Reported Event|No Intervention|No educational intervention
10960552|NCT00856583|BG000|Baseline|Sertindole|Normally in the range of 4 to 20 mg/day
10960553|NCT00856583|BG001|Baseline|Risperidone|Normally in the range of 2 to 8 mg/day
10960554|NCT00856583|BG002|Baseline|Total|Total of all reporting groups
10960555|NCT00856583|FG000|Participant Flow|Sertindole|Normally in the range of 4 to 20 mg/day
10960556|NCT00856583|FG001|Participant Flow|Risperidone|Normally in the range of 2 to 8 mg/day
10960557|NCT00856583|OG000|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
10960558|NCT00856583|OG001|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
10960559|NCT00856583|EG000|Reported Event|Sertindole|Normally in the range of 4 to 20 mg/day
11179634|NCT02057549|EG000|Reported Event|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
11179635|NCT02057549|EG001|Reported Event|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
11179636|NCT02057575|BG000|Baseline|PG324 Ophthalmic Solution 0.01%|"PG324 Ophthalmic Solution 0.01%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179637|NCT02057575|BG001|Baseline|PG324 Ophthalmic Solution 0.02%|"PG324 Ophthalmic Solution 0.02%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179638|NCT02057575|BG002|Baseline|Netarsudil (AR-13324) Ophthalmic Solution 0.02%|"Netarsudil (AR-13324) Ophthalmic Solution 0.02%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179639|NCT02057575|BG003|Baseline|Latanoprost Ophthalmic Solution 0.005%|"Latanoprost Ophthalmic Solution 0.005%~1 drop daily in the evening (PM), once daily (QD), both eyes (OU)"
11179640|NCT02057575|BG004|Baseline|Total|Total of all reporting groups
11179641|NCT02057575|FG000|Participant Flow|PG324 Ophthalmic Solution 0.01%|"PG324 Ophthalmic Solution 0.01%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179642|NCT02057575|FG001|Participant Flow|PG324 Ophthalmic Solution 0.02%|"PG324 Ophthalmic Solution 0.02%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179643|NCT02057575|FG002|Participant Flow|Netarsudil (AR-13324) Ophthalmic Solution 0.02%|"Netarsudil (AR-13324) Ophthalmic Solution 0.02%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179644|NCT02057575|FG003|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|"Latanoprost Ophthalmic Solution 0.005%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179645|NCT02057575|OG000|Outcome|PG324 Ophthalmic Solution 0.01%|"PG324 Ophthalmic Solution 0.01%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
10960560|NCT00856583|EG001|Reported Event|Risperidone|Normally in the range of 2 to 8 mg/day
10960561|NCT00856609|BG000|Baseline|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
10960562|NCT00856609|BG001|Baseline|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
10960563|NCT00856609|BG002|Baseline|Total|Total of all reporting groups
10960564|NCT00856609|FG000|Participant Flow|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
10960565|NCT00856609|FG001|Participant Flow|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
10960566|NCT00856609|OG000|Outcome|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
10960567|NCT00856609|OG001|Outcome|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
10960568|NCT00856609|EG000|Reported Event|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
10960569|NCT00856609|EG001|Reported Event|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
11179646|NCT02057575|OG001|Outcome|PG324 Ophthalmic Solution 0.02%|"PG324 Ophthalmic Solution 0.02%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179647|NCT02057575|OG002|Outcome|Netarsudil (AR-13324) Ophthalmic Solution|"Netarsudil (AR-13324) Ophthalmic Solution~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179648|NCT02057575|OG003|Outcome|Latanoprost Ophthalmic Solution|"Latanoprost Ophthalmic Solution~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179649|NCT02057575|EG000|Reported Event|PG324 Ophthalmic Solution 0.01%|"PG324 Ophthalmic Solution 0.01%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179650|NCT02057575|EG001|Reported Event|PG324 Ophthalmic Solution 0.02%|"PG324 Ophthalmic Solution 0.02%~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179651|NCT02057575|EG002|Reported Event|Netarsudil (AR-13324) Ophthalmic Solution|"Netarsudil (AR-13324) Ophthalmic Solution~1 drop in the evening (PM), once daily (QD), both eyes (OU)"
11179652|NCT02057575|EG003|Reported Event|Latanoprost Ophthalmic Solution|"Latanoprost Ophthalmic Solution~Latanoprost Ophthalmic Solution: 1 drop daily (evening)"
11179653|NCT02057640|BG000|Baseline|Phase I|Ixazomib - DL 1
11179654|NCT02057640|BG001|Baseline|Phase I/II|Ixazomib -DL2
11179655|NCT02057640|BG002|Baseline|Total|Total of all reporting groups
11179656|NCT02057640|FG000|Participant Flow|DL1 - 3mg Lxazomib|Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
11179657|NCT02057640|FG001|Participant Flow|DL2 - 4mg Lxazomib|Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
11179658|NCT02057640|OG000|Outcome|Dose Levels 1|Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
11179659|NCT02057640|OG000|Outcome|DL1 - 3mg Lxazomib|Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
11179660|NCT02057640|OG001|Outcome|DL2 - 4mg Lxazomib|Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
11179661|NCT02057640|EG000|Reported Event|DL1 - 3mg Lxazomib|Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
11179662|NCT02057640|EG001|Reported Event|DL2 - 4mg Lxazomib|Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 4mg on day 1, 8, 15, 28
11179663|NCT02057666|BG000|Baseline|Tasquinimod|"One capsule (0.25, 0.50 or 1 mg), taken orally once a day with water and food (preferably the main evening meal).~A patient initially received a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively."
11179664|NCT02057666|BG001|Baseline|Placebo|"One capsule, taken orally once a day with water and food (preferably the main evening meal).~Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod)."
11179665|NCT02057666|BG002|Baseline|Total|Total of all reporting groups
11179666|NCT02057666|FG000|Participant Flow|Tasquinimod|"One capsule (0.25, 0.50 or 1 mg), taken orally once a day with water and food (preferably the main evening meal).~A patient initially received 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively."
11179667|NCT02057666|FG001|Participant Flow|Placebo|"One capsule, taken orally once a day with water and food (preferably the main evening meal).~Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod)."
11179668|NCT02057666|OG000|Outcome|Tasquinimod|"One capsule (0.25, 0.50 or 1 mg), taken orally once a day with water and food (preferably the main evening meal).~A patient initially received a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively."
11179669|NCT02057666|OG001|Outcome|Placebo|"One capsule, taken orally once a day with water and food (preferably the main evening meal).~Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod)."
11179670|NCT02057666|EG000|Reported Event|Tasquinimod|"One capsule (0.25, 0.50 or 1 mg), taken orally once a day with water and food (preferably the main evening meal).~A patient initially received a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively."
11179671|NCT02057666|EG001|Reported Event|Placebo|"One capsule, taken orally once a day with water and food (preferably the main evening meal).~Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod)."
11179672|NCT02057692|BG000|Baseline|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
11179673|NCT02057692|BG001|Baseline|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
11179674|NCT02057692|BG002|Baseline|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
11179675|NCT02057692|BG003|Baseline|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
11179676|NCT02057692|BG004|Baseline|Total|Total of all reporting groups
11179677|NCT02057692|FG000|Participant Flow|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
11179678|NCT02057692|FG001|Participant Flow|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
11179679|NCT02057692|FG002|Participant Flow|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
11179680|NCT02057692|FG003|Participant Flow|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
11179681|NCT02057692|OG000|Outcome|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
11179682|NCT02057692|OG001|Outcome|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
10960570|NCT00856635|BG000|Baseline|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
11179683|NCT02057692|OG002|Outcome|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
11179684|NCT02057692|OG003|Outcome|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
11179685|NCT02057692|OG000|Outcome|Maralixibat 14 mcg/kg/Day|Participants received 14 mcg/kg/day of maralixibat oral solution for 1 week. One participant assigned to the 70μg/kg/day arm, was withdrawn from the study after receiving a single dose of 14 mcg/kg/day dose. TEAE was reported separately for this participant using this arm.
11179686|NCT02057692|OG001|Outcome|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
11179687|NCT02057692|OG002|Outcome|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
11179688|NCT02057692|OG003|Outcome|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
11179689|NCT02057692|OG004|Outcome|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
11179690|NCT02057692|EG000|Reported Event|Maralixibat 14 mcg/kg/Day|Participants received 14 mcg/kg/day of maralixibat oral solution for 1 week. One participant assigned to the 70μg/kg/day arm, was withdrawn from the study after receiving a single dose of 14 mcg/kg/day dose. TEAE was reported separately for this participant using this arm.
11179691|NCT02057692|EG001|Reported Event|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
10960571|NCT00856635|BG001|Baseline|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
10960572|NCT00856635|BG002|Baseline|Total|Total of all reporting groups
10960573|NCT00856635|FG000|Participant Flow|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
10960574|NCT00856635|FG001|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
10960575|NCT00856635|OG000|Outcome|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
10960576|NCT00856635|OG001|Outcome|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
11179692|NCT02057692|EG002|Reported Event|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
11179693|NCT02057692|EG003|Reported Event|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
11179694|NCT02057692|EG004|Reported Event|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
11179695|NCT02057718|BG000|Baseline|PFIC1|Sub-group analysis of enrolled subjects with PFIC1 subtype
10960577|NCT00856635|OG000|Outcome|Glatiramer Acetate|"Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.~Glatiramer Acetate: 20 mg injected daily subcutaneously"
10960578|NCT00856635|OG001|Outcome|Placebo|"Participants received placebo subcutaneous injection once a day for up to 6 months.~placebo: injected daily subcutaneously"
10960579|NCT00856635|EG000|Reported Event|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
11179696|NCT02057718|BG001|Baseline|PFIC2 (Overall)|Sub-group analysis of overall PFIC2 subtype to include PFIC2 phenotype: - non-truncating (mild to moderate phenotype with residual BSEP [liver-specific transporter] function) - truncating (severe phenotype without residual BSEP function or complete absence of BSEP)
11179697|NCT02057718|BG002|Baseline|Total|Total of all reporting groups
11179698|NCT02057718|FG000|Participant Flow|Progressive Familial Intrahepatic Cholestasis 1 (PFIC1)|Enrolled subjects with PFIC1 subtype. All subjects received Maralixibat (LUM001; MRX).
10960580|NCT00856635|EG001|Reported Event|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
10960581|NCT00856661|BG000|Baseline|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
10960582|NCT00856661|BG001|Baseline|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
10960583|NCT00856661|BG002|Baseline|Total|Total of all reporting groups
10960584|NCT00856661|FG000|Participant Flow|Desmoteplase|90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
10960585|NCT00856661|FG001|Participant Flow|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
10960586|NCT00856661|OG000|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
10960587|NCT00856661|OG001|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
10960588|NCT00856661|EG000|Reported Event|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
10960589|NCT00856661|EG001|Reported Event|Desmoteplase|Desmoteplase: 90 ug/kg, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
10960590|NCT00856726|BG000|Baseline|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
10960591|NCT00856726|FG000|Participant Flow|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
10960592|NCT00856726|OG000|Outcome|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
10960593|NCT00856726|EG000|Reported Event|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
10960594|NCT00856739|BG000|Baseline|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
10960595|NCT00856739|BG001|Baseline|Overweight|Body mass index between 25 and 30 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
10960596|NCT00856739|BG002|Baseline|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
10960597|NCT00856739|BG003|Baseline|Total|Total of all reporting groups
10960598|NCT00856739|FG000|Participant Flow|Normal Weight|Body mass index between 18 and 25 kg/m^2
10960599|NCT00856739|FG001|Participant Flow|Overweight|Body mass index between 25 and 30 kg/m^2
10960600|NCT00856739|FG002|Participant Flow|Obese|Body mass index over 30 kg/m^2
10960601|NCT00856739|OG000|Outcome|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
10960602|NCT00856739|OG001|Outcome|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
10960603|NCT00856739|OG000|Outcome|Normal Weight Young|Body mass index between 18 and 25 kg/m^2, age between 20 and 35
10960604|NCT00856739|OG001|Outcome|Overweight and Obese Young|Body mass index between 27 and 50 kg/m^2, age between 20 and 35
10960605|NCT00856739|OG002|Outcome|Normal Weight Middle Age|Body mass index between 18 and 25 kg/m^2, age between 35 and 60
10960606|NCT00856739|OG003|Outcome|Overweight and Obese Middle Age|Body mass index between 27 and 50 kg/m^2, age between 35 and 60
10960607|NCT00856739|EG000|Reported Event|Normal Weight|Body mass index between 18 and 25 kg/m^2
10960608|NCT00856739|EG001|Reported Event|Overweight|Body mass index between 25 and 30 kg/m^2
10960609|NCT00856739|EG002|Reported Event|Obese|Body mass index between 30 and 50 kg/m^2
10960610|NCT00856778|BG000|Baseline|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
10960611|NCT00856778|FG000|Participant Flow|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
10960612|NCT00856778|OG000|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
10960613|NCT00856778|EG000|Reported Event|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
10960614|NCT00856791|BG000|Baseline|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
10960615|NCT00856791|FG000|Participant Flow|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
10960616|NCT00856791|OG000|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
10960617|NCT00856791|EG000|Reported Event|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
10960618|NCT00856830|BG000|Baseline|Regimen A: Cohort I Bendamustine 80 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 80 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
10960619|NCT00856830|BG001|Baseline|Regimen A: Cohort II Bendamustine 100 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 100 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
10960620|NCT00856830|BG002|Baseline|Regimen A: Cohort III Bendamustine 120 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 120 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
10960621|NCT00856830|BG003|Baseline|Regimen A: Cohort IV Bendamustine 100 -120 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. Bendamustine was given at 100 - 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
10960622|NCT00856830|BG004|Baseline|Total|Total of all reporting groups
10963871|NCT00874731|EG001|Reported Event|Pt 1, Day 2. Ridaforolimus 100 mg|[Pt 1, Day 2]: Following completion of Part 1 / Day 1, participants received a single dose of ridaforolimus 100 mg (10 x 10 mg oral tablets) on Day 2 of Part 1. Following completion of Part 1 / Day 2, participants entered a washout period of ≥5 days before the first dose Part 2.
10960623|NCT00856830|FG000|Participant Flow|Phase I - Regimen A: Cohort I (80 mg/m2) - Bendamustine (B)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (80 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles.
10960624|NCT00856830|FG001|Participant Flow|Phase I - Regimen A: Cohort II 100mg/m2) - (B)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (100 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles.~Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
10960625|NCT00856830|FG002|Participant Flow|Phase I - Regimen A: Cohort III (120 mg/M2) - (B)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (120 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles.~Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
10960626|NCT00856830|FG003|Participant Flow|Phase II - Regimen A: Cohort IV (B) 100 -120 mg/m2 (Day 1,2)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at bendamustine 100-120 mg/m2 (Day 1,2). This was repeated every 21 days for a total of 3 cycles.~Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
10960627|NCT00856830|OG000|Outcome|Novel Drug Combination|"There is only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.~Bendamustine, Irinotecan, Etoposide/Carboplatin (Novel drug combination): Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.~All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging.~At the end (3 weeks after) of the sixth total round of chemotherapy, subjects will be re-evaluated for response, and will be followed"
10960628|NCT00856830|OG000|Outcome|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.~This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.~Novel Drug Combination: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.~•All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging."
10960629|NCT00856830|EG000|Reported Event|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.~Novel Drug Combination: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.~•All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging."
10960630|NCT00856843|BG000|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
10960631|NCT00856843|BG001|Baseline|BLI800|Investigational prep - oral solution, 1 administration
10960632|NCT00856843|BG002|Baseline|Total|Total of all reporting groups
10960633|NCT00856843|FG000|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
10960634|NCT00856843|FG001|Participant Flow|BLI800|Investigational prep - oral solution, 1 administration
10960635|NCT00856843|OG000|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
10960636|NCT00856843|OG001|Outcome|BLI800|Investigational prep - oral solution, 1 administration
10960637|NCT00856843|EG000|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
10960638|NCT00856843|EG001|Reported Event|BLI800|Investigational prep - oral solution, 1 administration
10963872|NCT00874731|EG002|Reported Event|Pt 2. Ridaforolimus 40 mg|[Pt 2]: Following completion of Part 1, participants received ridaforolimus 40 mg (4 x 10 mg oral tablets) given once daily (QD) for 5 consecutive days followed by 2 days off-drug.
11179699|NCT02057718|FG001|Participant Flow|Progressive Familial Intrahepatic Cholestasis 2 (PFIC2) (Overall)|Overall PFIC2 subtype to include PFIC2 phenotype: - non-truncating (mild to moderate phenotype with residual BSEP [liver-specific transporter] function) - truncating (severe phenotype without residual BSEP function or complete absence of BSEP). All subjects received Maralixibat (LUM001; MRX).
11179700|NCT02057718|OG000|Outcome|Maralixibat|All subjects received maralixibat (MRX)
11179701|NCT02057718|OG001|Outcome|PFIC1|Enrolled subjects with PFIC1 subtype
11179702|NCT02057718|OG002|Outcome|PFIC2 (Overall)|Overall PFIC2 subtype to include PFIC2 phenotype: - non-truncating (mild to moderate phenotype with residual BSEP [liver-specific transporter] function) - truncating (severe phenotype without residual BSEP function or complete absence of BSEP)
11179703|NCT02057718|EG000|Reported Event|Safety Population|The safety population is defined as all subjects who were assigned and received at least one dose of the study drug. Safety analysis consists of the MITT population (Modified Intent-to-Treat [MITT]). The arms have been combined to have one larger analysis population, thus allowing for a more robust understanding of the incidence rates of AEs for patients with PFIC treated with Maralixibat.
11179704|NCT02057757|BG000|Baseline|Nitazoxanide (NTZ)|"Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.~Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.~Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days."
11179705|NCT02057757|BG001|Baseline|Placebo|"Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.~Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.~Participants 12 years and older: two placebo tablets orally twice daily for 5 days."
10960639|NCT00856856|BG000|Baseline|Absorb BVS|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.~Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor."
10960640|NCT00856856|FG000|Participant Flow|Absorb BVS|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.~Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor."
11357672|NCT03750695|FG000|Participant Flow|Rest, Then Aerobic Exercise, and Then Resistance Exercise Order|"Rest: 40 minutes of quiet rest in semi-recumbent position~Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)~Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise~Participant performed interventions in order of rest, then aerobic exercise, then resistance exercise."
11357673|NCT03750695|FG001|Participant Flow|Rest-Resistance-Aerobic Order|"Rest: 40 minutes of quiet rest in semi-recumbent position Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise~Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)~Participant performed interventions in order of rest, then resistance exercise, then aerobic exercise."
11357674|NCT03750695|OG000|Outcome|Acute Aerobic Exercise|Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)
10960641|NCT00856856|OG000|Outcome|Absorb BVS|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.~Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor."
11179706|NCT02057757|BG002|Baseline|Total|Total of all reporting groups
11179707|NCT02057757|FG000|Participant Flow|Nitazoxanide (NTZ)|"Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.~Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.~Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days."
11357675|NCT03750695|OG001|Outcome|Acute Resistance Exercise|Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise
11357676|NCT03750695|OG002|Outcome|Acute Rest|1-hour of sitting rest
11357677|NCT03750695|OG000|Outcome|Acute Resistance Exercise|"One acute exercise session of 40 minutes of resistance exercise~Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise"
11357678|NCT03750695|OG001|Outcome|Acute Aerobic Exercise|"One acute session of 40 minutes of aerobic exercise~Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)"
11357679|NCT03750695|OG002|Outcome|Acute Rest|"One session of 40 minutes of quiet rest~Rest: 40 minutes of quiet rest in semi-recumbent position"
11357680|NCT03750695|EG000|Reported Event|Acute Resistance Exercise|"One acute exercise session of 40 minutes of resistance exercise~Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise"
10963873|NCT00874770|BG000|Baseline|Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11357681|NCT03750695|EG001|Reported Event|Acute Aerobic Exercise|"One acute session of 40 minutes of aerobic exercise~Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)"
10960642|NCT00856856|OG000|Outcome|Absorb BVS|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.~Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor."
10960643|NCT00856856|OG000|Outcome|Absorb BVS|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS).~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.~Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm.~Cohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years."
10960644|NCT00856856|OG000|Outcome|ABSORB Stent|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.~Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor."
10960645|NCT00856856|OG000|Outcome|Absorb Stent|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.~Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor."
10960646|NCT00856856|OG000|Outcome|Absorb BVS|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease"
10960647|NCT00856856|EG000|Reported Event|ABSORB Stent|"Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)~Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease"
10960648|NCT00856908|BG000|Baseline|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
10960649|NCT00856908|BG001|Baseline|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
10960650|NCT00856908|BG002|Baseline|Total|Total of all reporting groups
10960651|NCT00856908|FG000|Participant Flow|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
10960652|NCT00856908|FG001|Participant Flow|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
10960653|NCT00856908|OG000|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
10960654|NCT00856908|OG001|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
10960655|NCT00856908|EG000|Reported Event|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
10960656|NCT00856908|EG001|Reported Event|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
10960657|NCT00856973|BG000|Baseline|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily. This included only patients that were randomized (ITT population).
10960658|NCT00856973|BG001|Baseline|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily. This includes only patients that were randomized (ITT population).
10960659|NCT00856973|BG002|Baseline|Placebo|Placebo Once Daily. This included only patients that were randomized (ITT population).
10960660|NCT00856973|BG003|Baseline|Total|Total of all reporting groups
10960661|NCT00856973|FG000|Participant Flow|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
10960662|NCT00856973|FG001|Participant Flow|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
10960663|NCT00856973|FG002|Participant Flow|Placebo|Placebo 6-17 years
10960664|NCT00856973|OG000|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
10960665|NCT00856973|OG001|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
10960666|NCT00856973|OG002|Outcome|Placebo|Placebo 6-17 years
10960667|NCT00856973|OG002|Outcome|Placebo|Placebo 6-17 years once daily
10960668|NCT00856973|OG000|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily
10960669|NCT00856973|OG001|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily
10960670|NCT00856973|OG002|Outcome|Placebo|Placebo once daily
10960671|NCT00856973|EG000|Reported Event|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
10960672|NCT00856973|EG001|Reported Event|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
10960673|NCT00856973|EG002|Reported Event|Placebo|Placebo 6-17 years once daily
11357682|NCT03750695|EG002|Reported Event|Acute Resting Session|"One session of 40 minutes of quiet rest~Rest: 40 minutes of quiet rest in semi-recumbent position"
10960674|NCT00856986|BG000|Baseline|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
10960675|NCT00856986|BG001|Baseline|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
10960676|NCT00856986|BG002|Baseline|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
10960677|NCT00856986|BG003|Baseline|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
10960678|NCT00856986|BG004|Baseline|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
10960679|NCT00856986|BG005|Baseline|Total|Total of all reporting groups
10960680|NCT00856986|FG000|Participant Flow|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
10960681|NCT00856986|FG001|Participant Flow|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
10960682|NCT00856986|FG002|Participant Flow|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
10960683|NCT00856986|FG003|Participant Flow|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
10960684|NCT00856986|FG004|Participant Flow|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
10960685|NCT00856986|OG000|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
11179708|NCT02057757|FG001|Participant Flow|Placebo|"Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.~Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.~Participants 12 years and older: two placebo tablets orally twice daily for 5 days."
10960686|NCT00856986|OG001|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
10963874|NCT00874770|BG001|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin|Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10960687|NCT00856986|OG002|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
10960688|NCT00856986|OG003|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
10960689|NCT00856986|OG004|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
10960690|NCT00856986|EG000|Reported Event|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
10960691|NCT00856986|EG001|Reported Event|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
10960692|NCT00856986|EG002|Reported Event|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
10960693|NCT00856986|EG003|Reported Event|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
10960694|NCT00856986|EG004|Reported Event|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
10960695|NCT00856999|BG000|Baseline|Botox|"Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups~Botox: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups"
10960696|NCT00856999|FG000|Participant Flow|Botox|"Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups~Botox: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups"
10960697|NCT00856999|OG000|Outcome|Treatment|26-month 2-phase study enrolling 50 toxin-naïve females aged 30-50 years with Fitzpatrick Skin Types I to III and moderate (2) to severe (3) glabellar lines on the 4-point Facial Wrinkle Scale at maximum contraction.
10960698|NCT00856999|OG000|Outcome|Treatment|Frown-line assessments
10960699|NCT00856999|EG000|Reported Event|Botox|"Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups~Botox: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups"
10960700|NCT00857207|BG000|Baseline|Arm 1: Treatment Goal Management Training|"Treatment Goal Management Training~Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks."
10960701|NCT00857207|BG001|Baseline|Arm 2: Control-Brain Health Workshop|"Control-Brain Health Workshop~Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training"
10960702|NCT00857207|BG002|Baseline|Total|Total of all reporting groups
10960703|NCT00857207|FG000|Participant Flow|Arm 1: Treatment Goal Management Training|"Treatment Goal Management Training~Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks."
10960704|NCT00857207|FG001|Participant Flow|Arm 2: Control-Brain Health Workshop|"Control-Brain Health Workshop~Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training"
10960705|NCT00857207|OG000|Outcome|Arm 1: Treatment Goal Management Training|"Treatment Goal Management Training~Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks."
10960706|NCT00857207|OG001|Outcome|Arm 2: Control-Brain Health Workshop|"Control-Brain Health Workshop~Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training"
10960707|NCT00857207|OG001|Outcome|Arm 2: Control-Brain Health Workshop|Control-Brain Health Workshop
10960708|NCT00857207|EG000|Reported Event|Arm 1: Treatment Goal Management Training|"Treatment Goal Management Training~Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks."
10960709|NCT00857207|EG001|Reported Event|Arm 2: Control-Brain Health Workshop|"Control-Brain Health Workshop~Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training"
10960710|NCT00857220|BG000|Baseline|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
10960711|NCT00857220|FG000|Participant Flow|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
10960712|NCT00857220|OG000|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
10960713|NCT00857220|EG000|Reported Event|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
10960714|NCT00857233|BG000|Baseline|Memantine|20 mg Oral Tablets Once Daily
10960715|NCT00857233|FG000|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
10960716|NCT00857233|OG000|Outcome|Memantine|20 mg Oral Tablets Once Daily
10960717|NCT00857233|EG000|Reported Event|Memantine|20 mg Oral Tablets Once Daily
11179709|NCT02057757|OG000|Outcome|Nitazoxanide (NTZ)|"Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.~Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.~Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days."
10960718|NCT00857246|BG000|Baseline|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (3-4 weeks after induction treatment).~Chemoradiation treatment (4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
10960719|NCT00857246|FG000|Participant Flow|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
10960720|NCT00857246|OG000|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
10960721|NCT00857246|OG000|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment ( starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
10960722|NCT00857246|OG000|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (3-4 weeks after induction treatment).~Chemoradiation treatment (4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
10960723|NCT00857246|OG000|Outcome|Induction Treatment|Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
10960724|NCT00857246|EG000|Reported Event|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
10960725|NCT00857259|BG000|Baseline|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
10960726|NCT00857259|BG001|Baseline|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
10960727|NCT00857259|BG002|Baseline|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
10960728|NCT00857259|BG003|Baseline|Total|Total of all reporting groups
10960729|NCT00857259|FG000|Participant Flow|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
10960730|NCT00857259|FG001|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
10960731|NCT00857259|FG002|Participant Flow|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
10960732|NCT00857259|OG000|Outcome|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
10960733|NCT00857259|OG001|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy 0.5 mg on Day 1 (baseline)
10960734|NCT00857259|OG002|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
10960735|NCT00857259|OG000|Outcome|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
10960736|NCT00857259|OG001|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (Baseline)
10960737|NCT00857259|OG002|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
10960738|NCT00857259|EG000|Reported Event|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
10960739|NCT00857259|EG001|Reported Event|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
10960740|NCT00857272|BG000|Baseline|HalfLytely With 5mg Bisacodyl|Investigational dose
10960741|NCT00857272|BG001|Baseline|HalfLytely With 10mg Bisacodyl|Active Control
10960742|NCT00857272|BG002|Baseline|Total|Total of all reporting groups
10960743|NCT00857272|FG000|Participant Flow|HalfLytely With 5mg Bisacodyl|Investigational dose
10960744|NCT00857272|FG001|Participant Flow|HalfLytely With 10mg Bisacodyl|Active Control
11179710|NCT02057757|OG001|Outcome|Placebo|"Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.~Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.~Participants 12 years and older: two placebo tablets orally twice daily for 5 days."
10960745|NCT00857272|OG000|Outcome|HalfLytely With 5mg Bisacodyl|Investigational dose
10960746|NCT00857272|OG001|Outcome|HalfLytely With 10mg Bisacodyl|Active Control
10960747|NCT00857272|EG000|Reported Event|HalfLytely With 5mg Bisacodyl|Investigational dose
10960748|NCT00857272|EG001|Reported Event|HalfLytely With 10mg Bisacodyl|Active Control
10960749|NCT00857311|BG000|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
10960750|NCT00857311|BG001|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
10960751|NCT00857311|BG002|Baseline|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
10960752|NCT00857311|BG003|Baseline|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
10960753|NCT00857311|BG004|Baseline|Total|Total of all reporting groups
10960754|NCT00857311|FG000|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
10960755|NCT00857311|FG001|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
10960756|NCT00857311|FG002|Participant Flow|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
10960757|NCT00857311|FG003|Participant Flow|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
10960758|NCT00857311|OG000|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
10960759|NCT00857311|OG001|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
10960760|NCT00857311|EG000|Reported Event|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
10960761|NCT00857311|EG001|Reported Event|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
10960762|NCT00857389|BG000|Baseline|Conditioning Reg- Thiotepa, Busulfan, and Clofarabine|The 5 mg/kg over 1 hr. Busulfan was administered x 3 days over 3 hr to a daily AUC of 5,000 mcMol-min +/-10%. Clofarabine 40mg/m2 was infused over 1 hr daily x 4 days
10960763|NCT00857389|FG000|Participant Flow|Conditioning Reg- Thiotepa, Busulfan, and Clofarabine|Single arm study
10960764|NCT00857389|OG000|Outcome|Conditioning Reg- Thiotepa, Busulfan, and Clofarabine|The 5 mg/kg over 1 hr. Busulfan was administered x 3 days over 3 hr to a daily AUC of 5,000 mcMol-min +/-10%. Clofarabine 40mg/m2 was infused over 1 hr daily x 4 days
10960765|NCT00857389|EG000|Reported Event|Conditioning Reg- Thiotepa, Busulfan, and Clofarabine|The 5 mg/kg over 1 hr. Busulfan was administered x 3 days over 3 hr to a daily AUC of 5,000 mcMol-min +/-10%. Clofarabine 40mg/m2 was infused over 1 hr daily x 4 days
10960766|NCT00857415|BG000|Baseline|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
10960767|NCT00857415|BG001|Baseline|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
10960768|NCT00857415|BG002|Baseline|Total|Total of all reporting groups
10960769|NCT00857415|FG000|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
10960770|NCT00857415|FG001|Participant Flow|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
10960771|NCT00857415|OG000|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
10960772|NCT00857415|OG000|Outcome|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques
10960773|NCT00857415|EG000|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
10960774|NCT00857415|EG001|Reported Event|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
10960775|NCT00857454|BG000|Baseline|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
10960776|NCT00857454|FG000|Participant Flow|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
10960777|NCT00857454|OG000|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
10960778|NCT00857454|EG000|Reported Event|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
10960779|NCT00857493|BG000|Baseline|Group 1|IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
10960780|NCT00857493|BG001|Baseline|Group 2|IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
10960781|NCT00857493|BG002|Baseline|Total|Total of all reporting groups
10960782|NCT00857493|FG000|Participant Flow|Group 1|IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
10960783|NCT00857493|FG001|Participant Flow|Group 2|IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
10960784|NCT00857493|OG000|Outcome|Group 1|IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
10960785|NCT00857493|OG001|Outcome|Group 2|IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
10960786|NCT00857493|EG000|Reported Event|Group 1|IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
10960787|NCT00857493|EG001|Reported Event|Group 2|IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
10960788|NCT00857506|BG000|Baseline|Alzheimer's Disease|
10960789|NCT00857506|BG001|Baseline|Mild Cognitive Impairment|
10960790|NCT00857506|BG002|Baseline|Cognitively Normal|
10960791|NCT00857506|BG003|Baseline|Total|Total of all reporting groups
10960792|NCT00857506|FG000|Participant Flow|Alzheimer's Disease|Subject's with Alzheimer's Disease were recruited from study 18F-AV-45-A05 (NCT00702143). None of these subjects received additional interventions in study 18F-AV-45-A11.
10960793|NCT00857506|FG001|Participant Flow|Mild Cognitive Impairment|Subject's with Mild Cognitive Impairment (MCI) were recruited from study 18F-AV-45-A05 (NCT00702143). 36 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
10960794|NCT00857506|FG002|Participant Flow|Cognitively Normal|Cognitively Normal (CN) subjects were recruited from study 18F-AV-45-A05 (NCT00702143). 50 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
10960795|NCT00857506|OG000|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
10960796|NCT00857506|OG001|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
10960797|NCT00857506|OG000|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
10960798|NCT00857506|OG001|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline.
10960799|NCT00857506|OG002|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
10960800|NCT00857506|OG003|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
10960801|NCT00857506|OG001|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. 57 subjects were analyzed for change in ADAS-Cog and 55 subjects were analyzed for change in CDR.
10960802|NCT00857506|OG001|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. All assessments were obtained for 57 subjects except for CDR-SOB and ADCS ADL which were obtained for 55 and 56 subjects respectively.
10960803|NCT00857506|OG002|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
10960804|NCT00857506|OG003|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
10960805|NCT00857506|OG004|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
10960806|NCT00857506|OG005|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
10960807|NCT00857506|OG000|Outcome|Alzheimer's Disease|Subjects with a baseline clinical diagnosis of AD.
10960808|NCT00857506|OG001|Outcome|Mild Cognitive Impairment|Subjects with a baseline clinical diagnosis of MCI.
10960809|NCT00857506|OG002|Outcome|Cognitively Normal|Subjects with a baseline clinical diagnosis of CN.
10960810|NCT00857506|EG000|Reported Event|Alzheimer's Disease|
10960811|NCT00857506|EG001|Reported Event|Mild Cognitive Impairment|
10960812|NCT00857506|EG002|Reported Event|Cognitively Normal|
10960813|NCT00857532|BG000|Baseline|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
10847199|NCT00282282|BG000|Baseline|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
10847200|NCT00282282|FG000|Participant Flow|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
10847201|NCT00282282|OG000|Outcome|Tacrolimus and Sirolimus|
10847202|NCT00282282|OG000|Outcome|Tacrolimus and Sirolimus GVHD Prophylaxis|
10847203|NCT00282282|EG000|Reported Event|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
10847204|NCT00282295|BG000|Baseline|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
10847205|NCT00282295|BG001|Baseline|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847206|NCT00282295|BG002|Baseline|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847207|NCT00282295|BG003|Baseline|Total|Total of all reporting groups
10847208|NCT00282295|FG000|Participant Flow|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
10847209|NCT00282295|FG001|Participant Flow|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847210|NCT00282295|FG002|Participant Flow|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847211|NCT00282295|OG000|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.
10847212|NCT00282295|OG001|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847213|NCT00282295|OG000|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.
10847214|NCT00282295|OG001|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847215|NCT00282295|OG002|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847216|NCT00282295|OG000|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847217|NCT00282295|OG000|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847218|NCT00282295|OG000|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10960814|NCT00857532|FG000|Participant Flow|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 megabecquerel (MBq) injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
10960815|NCT00857532|OG000|Outcome|Subjects With Normal Cognitive Performance|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score greater than or equal to 9.
10960816|NCT00857532|OG001|Outcome|Subjects With Mild Cognitive Deficits|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score between 6 and 8 inclusive.
10960817|NCT00857532|OG002|Outcome|Subjects With Moderate to Severe Cognitive Impairment|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score 5 and below.
10960818|NCT00857532|OG000|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
10960819|NCT00857532|EG000|Reported Event|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
10960820|NCT00857545|BG000|Baseline|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
10960821|NCT00857545|BG001|Baseline|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
10960822|NCT00857545|BG002|Baseline|Total|Total of all reporting groups
10960823|NCT00857545|FG000|Participant Flow|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
11179711|NCT02057757|OG000|Outcome|Nitazoxanide (NTZ) - Adults >=18 Years|"Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.~Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.~Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days."
10960824|NCT00857545|FG001|Participant Flow|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
10960825|NCT00857545|OG000|Outcome|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
10960826|NCT00857545|OG001|Outcome|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
10960827|NCT00857545|EG000|Reported Event|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
10960828|NCT00857545|EG001|Reported Event|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
10960829|NCT00857584|BG000|Baseline|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
10960830|NCT00857584|BG001|Baseline|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
10960831|NCT00857584|BG002|Baseline|Total|Total of all reporting groups
10960832|NCT00857584|FG000|Participant Flow|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
10960833|NCT00857584|FG001|Participant Flow|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
10960834|NCT00857584|OG000|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
10960835|NCT00857584|OG001|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
10960836|NCT00857584|EG000|Reported Event|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
10960837|NCT00857584|EG001|Reported Event|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
10960838|NCT00857623|BG000|Baseline|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
10960839|NCT00857623|BG001|Baseline|Placebo|Capsule, once daily
10960840|NCT00857623|BG002|Baseline|Total|Total of all reporting groups
10960841|NCT00857623|FG000|Participant Flow|AZD2066|Capsule, once daily. 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
10960842|NCT00857623|FG001|Participant Flow|Placebo|Capsule, once daily
10960843|NCT00857623|OG000|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
10960844|NCT00857623|OG001|Outcome|Placebo|Capsule, once daily
10960845|NCT00857623|EG000|Reported Event|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
10960846|NCT00857623|EG001|Reported Event|Placebo|Capsule, once daily
10960847|NCT00857649|BG000|Baseline|Memantine|20 mg Oral Tablets Once Daily
10960848|NCT00857649|BG001|Baseline|Placebo|Oral Tablets Once Daily
10960849|NCT00857649|BG002|Baseline|Total|Total of all reporting groups
10960850|NCT00857649|FG000|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
10960851|NCT00857649|FG001|Participant Flow|Placebo|Oral Tablets Once Daily
10960852|NCT00857649|OG000|Outcome|Memantine|20 mg Oral Tablets Once Daily
10960853|NCT00857649|OG001|Outcome|Placebo|Oral Tablets Once Daily
10960854|NCT00857649|EG000|Reported Event|Memantine|20 mg Oral Tablets Once Daily
10960855|NCT00857649|EG001|Reported Event|Placebo|Oral Tablets Once Daily
10960856|NCT00857714|BG000|Baseline|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
10960857|NCT00857714|FG000|Participant Flow|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
10960858|NCT00857714|OG000|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
10960859|NCT00857714|EG000|Reported Event|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
10960860|NCT00857727|BG000|Baseline|Drug|Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.
10960861|NCT00857727|BG001|Baseline|Control|Normal Saline IV solution - Given by a continuous infusion
10960862|NCT00857727|BG002|Baseline|Total|Total of all reporting groups
10960863|NCT00857727|FG000|Participant Flow|Drug|Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.
10960864|NCT00857727|FG001|Participant Flow|Control|Normal Saline IV solution - Given by a continuous infusion
10960865|NCT00857727|OG000|Outcome|Drug|Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.
10960866|NCT00857727|OG001|Outcome|Control|Normal Saline IV solution - Given by a continuous infusion
10960867|NCT00857727|EG000|Reported Event|Drug|Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.
10960868|NCT00857727|EG001|Reported Event|Control|Normal Saline IV solution - Given by a continuous infusion
10960869|NCT00857766|BG000|Baseline|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
10960870|NCT00857766|BG001|Baseline|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
10960871|NCT00857766|BG002|Baseline|Total|Total of all reporting groups
10960872|NCT00857766|FG000|Participant Flow|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
10960873|NCT00857766|FG001|Participant Flow|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
10960874|NCT00857766|OG000|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
10960875|NCT00857766|OG001|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
10960876|NCT00857766|EG000|Reported Event|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
10960877|NCT00857766|EG001|Reported Event|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
10960878|NCT00857792|BG000|Baseline|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
10960879|NCT00857792|FG000|Participant Flow|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
10960880|NCT00857792|OG000|Outcome|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
10960881|NCT00857792|EG000|Reported Event|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
10960882|NCT00857818|BG000|Baseline|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
10960883|NCT00857818|BG001|Baseline|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
10960884|NCT00857818|BG002|Baseline|Total|Total of all reporting groups
10960885|NCT00857818|FG000|Participant Flow|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
10960886|NCT00857818|FG001|Participant Flow|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
10960887|NCT00857818|OG000|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
10960888|NCT00857818|OG001|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
10960889|NCT00857818|EG000|Reported Event|ARIPIPRAZOLE|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
10960890|NCT00857818|EG001|Reported Event|CONTROL GROUP|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
10960891|NCT00857857|BG000|Baseline|Overall Study|Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 mg, 1 mg, 3 mg OD, active control (fluticasone propionate 0.25mg BID) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as MDPI. GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
10960892|NCT00857857|FG000|Participant Flow|Overall Study|Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 milligram (mg), 1 mg, 3 mg once daily (OD), active control (fluticasone propionate 0.25 mg bi-daily [BID]) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as multi-dose powder inhaler (MDPI). GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
10960893|NCT00857857|OG000|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
10960894|NCT00857857|OG001|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
10960895|NCT00857857|OG002|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
10960896|NCT00857857|OG003|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
10960897|NCT00857857|OG004|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
10960898|NCT00857857|EG000|Reported Event|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
10960899|NCT00857857|EG001|Reported Event|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
10960900|NCT00857857|EG002|Reported Event|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
10960901|NCT00857857|EG003|Reported Event|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
11179712|NCT02057757|OG001|Outcome|Placebo - Adults >=18 Years|"Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.~Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.~Participants 12 years and older: two placebo tablets orally twice daily for 5 days."
10960902|NCT00857857|EG004|Reported Event|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
10960903|NCT00857896|BG000|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
10960904|NCT00857896|FG000|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
10960905|NCT00857896|OG000|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
10960906|NCT00857896|EG000|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet QD anytime during the study
10960907|NCT00857896|EG001|Reported Event|Fesoterodine 8 mg|Fesoterodine 8 mg tablet QD anytime during the study
10960908|NCT00857948|BG000|Baseline|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
10960909|NCT00857948|BG001|Baseline|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
11179713|NCT02057757|OG002|Outcome|Nitazoxanide (NTZ) - Children <18 Years|"Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.~Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.~Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days."
11179714|NCT02057757|OG003|Outcome|Placebo - Children <18 Years|"Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.~Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.~Participants 12 years and older: two placebo tablets orally twice daily for 5 days."
11179715|NCT02057757|EG000|Reported Event|Nitazoxanide (NTZ)|"Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.~Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.~Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days."
11179716|NCT02057757|EG001|Reported Event|Placebo|"Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.~Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.~Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.~Participants 12 years and older: two placebo tablets orally twice daily for 5 days."
10960910|NCT00857948|BG002|Baseline|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
11179717|NCT02057835|BG000|Baseline|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
11179718|NCT02057835|BG001|Baseline|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179719|NCT02057835|BG002|Baseline|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
10960911|NCT00857948|BG003|Baseline|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
10960912|NCT00857948|BG004|Baseline|Total|Total of all reporting groups
10960913|NCT00857948|FG000|Participant Flow|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
10960914|NCT00857948|FG001|Participant Flow|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
10960915|NCT00857948|FG002|Participant Flow|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
10960916|NCT00857948|FG003|Participant Flow|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
10960917|NCT00857948|OG000|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
10960918|NCT00857948|OG001|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
10960919|NCT00857948|OG002|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
10960920|NCT00857948|OG003|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
10960921|NCT00857948|EG000|Reported Event|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
10960922|NCT00857948|EG001|Reported Event|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
10960923|NCT00857948|EG002|Reported Event|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
10960924|NCT00857948|EG003|Reported Event|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
10960925|NCT00857961|BG000|Baseline|Testosterone MD-Lotion|"Applied once daily for 7 days.~All study participants received each of the 4 study treatments:~3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).~1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.~3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).~4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
10960926|NCT00857961|FG000|Participant Flow|Testosterone MD-Lotion|"Applied once daily for 7 days.~All study participants received each of the 4 study treatments:~3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).~1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.~3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).~4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
10960927|NCT00857961|OG000|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
10960928|NCT00857961|OG001|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
10960929|NCT00857961|OG002|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
10960930|NCT00857961|OG003|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
10960931|NCT00857961|EG000|Reported Event|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
10960932|NCT00857961|EG001|Reported Event|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
10960933|NCT00857961|EG002|Reported Event|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
10960934|NCT00857961|EG003|Reported Event|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
10960935|NCT00858013|BG000|Baseline|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
10960936|NCT00858013|BG001|Baseline|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
10960937|NCT00858013|BG002|Baseline|Total|Total of all reporting groups
10960938|NCT00858013|FG000|Participant Flow|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
10960939|NCT00858013|FG001|Participant Flow|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
10960940|NCT00858013|OG000|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
10960941|NCT00858013|OG001|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
10960942|NCT00858013|EG000|Reported Event|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
10960943|NCT00858013|EG001|Reported Event|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
10960944|NCT00858117|BG000|Baseline|Alemtuzumab and Rituximab|"Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.~Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks~Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks"
10960945|NCT00858117|FG000|Participant Flow|Alemtuzumab and Rituximab|"Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.~Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks~Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks"
10960946|NCT00858117|OG000|Outcome|Alemtuzumab and Rituximab|"Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.~Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks~Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks"
10960947|NCT00858117|EG000|Reported Event|Alemtuzumab and Rituximab|"Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.~Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks~Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks"
10960948|NCT00858130|BG000|Baseline|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~VeinoPlus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
10960949|NCT00858130|FG000|Participant Flow|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~Veinoplus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
10960950|NCT00858130|OG000|Outcome|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~VeinoPlus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
10963875|NCT00874770|BG002|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin|Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10960951|NCT00858130|OG000|Outcome|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~Veinoplus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
10960952|NCT00858130|EG000|Reported Event|VeinoPlus Experimental Arm|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~VeinoPlus: The VeinoPlus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
10960953|NCT00858143|BG000|Baseline|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
10960954|NCT00858143|FG000|Participant Flow|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
10960955|NCT00858143|OG000|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
10960956|NCT00858143|EG000|Reported Event|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
10960957|NCT00858208|BG000|Baseline|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
10960958|NCT00858208|FG000|Participant Flow|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
10960959|NCT00858208|OG000|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
10960960|NCT00858208|EG000|Reported Event|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
10960961|NCT00858234|BG000|Baseline|Vorinostat + Bortezomib|Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11).
10960962|NCT00858234|FG000|Participant Flow|Vorinostat + Bortezomib|Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11).
10960963|NCT00858234|OG000|Outcome|Vorinostat + Bortezomib|Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11).
10960964|NCT00858234|EG000|Reported Event|Vorinostat + Bortezomib|Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11).
10960965|NCT00858247|BG000|Baseline|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily
10960966|NCT00858247|BG001|Baseline|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily
10960967|NCT00858247|BG002|Baseline|Total|Total of all reporting groups
10960968|NCT00858247|FG000|Participant Flow|Vitamin D3-low Dose|"Vitamin D3 400 IU capsule, one capsule daily~Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
10960969|NCT00858247|FG001|Participant Flow|Vitamin D3-high Dose|"Vitamin D3 2000 IU capsule, one capsule daily~Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
10960970|NCT00858247|OG000|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
10960971|NCT00858247|OG001|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
10960972|NCT00858247|EG000|Reported Event|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
10960973|NCT00858247|EG001|Reported Event|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
10960974|NCT00858364|BG000|Baseline|Placebo|Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
10960975|NCT00858364|BG001|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
10960976|NCT00858364|BG002|Baseline|Total|Total of all reporting groups
10960977|NCT00858364|FG000|Participant Flow|Placebo|Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
10960978|NCT00858364|FG001|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
10960979|NCT00858364|OG000|Outcome|Placebo|Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
10960980|NCT00858364|OG001|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
10960981|NCT00858364|EG000|Reported Event|Placebo|Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
10960982|NCT00858364|EG001|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
10960983|NCT00858390|BG000|Baseline|1 Standard Care|18 organ donors receiving standard care
10960984|NCT00858390|BG001|Baseline|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
10960985|NCT00858390|BG002|Baseline|Total|Total of all reporting groups
10960986|NCT00858390|FG000|Participant Flow|1 Standard Care|18 organ donors receiving standard care
10960987|NCT00858390|FG001|Participant Flow|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
10960988|NCT00858390|OG000|Outcome|1 Standard Care|18 organ donors receiving standard care
10960989|NCT00858390|OG001|Outcome|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
10960990|NCT00858390|EG000|Reported Event|1 Standard Care|18 organ donors receiving standard care
10960991|NCT00858390|EG001|Reported Event|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
10960992|NCT00858403|BG000|Baseline|Treatment With Dasatinib|
10960993|NCT00858403|FG000|Participant Flow|Treatment With Dasatinib|
10960994|NCT00858403|OG000|Outcome|Treatment With Dasatinib|
10960995|NCT00858403|EG000|Reported Event|Treatment With Dasatinib|
10960996|NCT00858442|BG000|Baseline|Without PRP|Patients with burns sequelae on their limbs treated with release of burns contractures and skin graft between 2008-2010.
10960997|NCT00858442|BG001|Baseline|With PRP|Patients with burns sequelae on their limbs treated with release of burn contractures and skin graft with PRP between 2008-2010.
10960998|NCT00858442|BG002|Baseline|Total|Total of all reporting groups
10960999|NCT00858442|FG000|Participant Flow|Without PRP|This arm did not receive any intervention
10961000|NCT00858442|FG001|Participant Flow|With PRP|4 cc of PRP is evenly distributed before the dermo-epidermic draft.
10961001|NCT00858442|OG000|Outcome|Without PRP|Patients did not received plasma enrich platelets
10961002|NCT00858442|OG001|Outcome|With PRP|Patients received plasma enriched platelets
10961003|NCT00858442|OG000|Outcome|Without PRP|Patients did not receive plasma enriched platelets
10961004|NCT00858442|EG000|Reported Event|Without PRP|Patients did not receive plasma enriched platelets
10961005|NCT00858442|EG001|Reported Event|With PRP|Patients received plasma enriched platelets
10961006|NCT00858468|BG000|Baseline|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
10961007|NCT00858468|BG001|Baseline|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
10961008|NCT00858468|BG002|Baseline|Total|Total of all reporting groups
10961009|NCT00858468|FG000|Participant Flow|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
10961010|NCT00858468|FG001|Participant Flow|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
10961011|NCT00858468|OG000|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
10961012|NCT00858468|OG001|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
10961013|NCT00858468|EG000|Reported Event|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
10961014|NCT00858468|EG001|Reported Event|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
10961015|NCT00858494|BG000|Baseline|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
10961016|NCT00858494|FG000|Participant Flow|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
10961017|NCT00858494|OG000|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
10961018|NCT00858494|EG000|Reported Event|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
10961019|NCT00858507|BG000|Baseline|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
10961020|NCT00858507|BG001|Baseline|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
10961021|NCT00858507|BG002|Baseline|Total|Total of all reporting groups
11179720|NCT02057835|BG003|Baseline|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961022|NCT00858507|FG000|Participant Flow|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
10961023|NCT00858507|FG001|Participant Flow|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
10961024|NCT00858507|OG000|Outcome|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
10961025|NCT00858507|OG001|Outcome|Arm 2: Usual Care|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
10961026|NCT00858507|EG000|Reported Event|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
10961027|NCT00858507|EG001|Reported Event|Arm 2: Usual Care|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
10961028|NCT00858637|BG000|Baseline|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.~One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
10961029|NCT00858637|BG001|Baseline|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated~There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.~One subject did not take any study medication and excluded from Baseline Participants.~In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
10961030|NCT00858637|BG002|Baseline|Total|Total of all reporting groups
10961031|NCT00858637|FG000|Participant Flow|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.~One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
11179721|NCT02057835|BG004|Baseline|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961032|NCT00858637|FG001|Participant Flow|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
10961033|NCT00858637|FG002|Participant Flow|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
10961034|NCT00858637|FG003|Participant Flow|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated~There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.~One subject did not take any study medication and excluded from Baseline Participants.~In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
10961035|NCT00858637|FG004|Participant Flow|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
10961036|NCT00858637|FG005|Participant Flow|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
10961037|NCT00858637|OG000|Outcome|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
10961038|NCT00858637|OG001|Outcome|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
11179722|NCT02057835|BG005|Baseline|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
10961039|NCT00858637|OG002|Outcome|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
10961040|NCT00858637|OG003|Outcome|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
10961041|NCT00858637|OG000|Outcome|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
10961042|NCT00858637|OG001|Outcome|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mgof Simvastatin / day as titrated
10961043|NCT00858637|EG000|Reported Event|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
11179723|NCT02057835|BG006|Baseline|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179724|NCT02057835|BG007|Baseline|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179725|NCT02057835|BG008|Baseline|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961044|NCT00858637|EG001|Reported Event|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
10961045|NCT00858689|BG000|Baseline|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
10961046|NCT00858689|FG000|Participant Flow|Minocyline 50 mg or 100 mg PO BID|open label, single arm study of minocyline 50 mg or 100 mg PO BID
10961047|NCT00858689|OG000|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
10961048|NCT00858689|EG000|Reported Event|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
10961049|NCT00858780|BG000|Baseline|Entire Study Population|Includes all participants who were enrolled in this study.
10961050|NCT00858780|FG000|Participant Flow|Etanercept 50 mg - Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
10961051|NCT00858780|FG001|Participant Flow|Etanercept 50 mg - Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
10961052|NCT00858780|FG002|Participant Flow|Etanercept 25 mg - Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
10961053|NCT00858780|FG003|Participant Flow|Placebo - Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
10961054|NCT00858780|FG004|Participant Flow|Etanercept 50 mg - Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
10961055|NCT00858780|OG000|Outcome|Etanercept 50 mg - Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
10961056|NCT00858780|OG001|Outcome|Etanercept 25 mg - Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
10961057|NCT00858780|OG002|Outcome|Placebo - Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
10961058|NCT00858780|EG000|Reported Event|Etanercept 50 mg - Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
10961059|NCT00858780|EG001|Reported Event|Etanercept 50 mg - Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
10961060|NCT00858780|EG002|Reported Event|Etanercept 25 mg - Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
10963876|NCT00874770|BG003|Baseline|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10963877|NCT00874770|BG004|Baseline|Total|Total of all reporting groups
10961061|NCT00858780|EG003|Reported Event|Placebo - Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
10961062|NCT00858780|EG004|Reported Event|Etanercept 50 mg - Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
10961063|NCT00858832|BG000|Baseline|Methergine|
10961064|NCT00858832|BG001|Baseline|No Methergine|
10961065|NCT00858832|BG002|Baseline|Total|Total of all reporting groups
10961066|NCT00858832|FG000|Participant Flow|Methergine|Participants received Methergine 0.2mg orally every 6 hours for 2 days
11179726|NCT02057835|BG009|Baseline|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179727|NCT02057835|BG010|Baseline|Total|Total of all reporting groups
11179728|NCT02057835|FG000|Participant Flow|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
11179729|NCT02057835|FG001|Participant Flow|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179730|NCT02057835|FG002|Participant Flow|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179731|NCT02057835|FG003|Participant Flow|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179732|NCT02057835|FG004|Participant Flow|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179733|NCT02057835|FG005|Participant Flow|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
11179734|NCT02057835|FG006|Participant Flow|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179735|NCT02057835|FG007|Participant Flow|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179736|NCT02057835|FG008|Participant Flow|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179737|NCT02057835|FG009|Participant Flow|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179738|NCT02057835|OG000|Outcome|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
11179739|NCT02057835|OG001|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179740|NCT02057835|OG002|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179741|NCT02057835|OG003|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179742|NCT02057835|OG004|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179743|NCT02057835|OG005|Outcome|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
11179744|NCT02057835|OG006|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179745|NCT02057835|OG007|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961067|NCT00858832|FG001|Participant Flow|No Treatment|Participants received no intervention (no treatment).
10961068|NCT00858832|OG000|Outcome|Methergine|
10961069|NCT00858832|OG001|Outcome|No Methergine|
10961070|NCT00858832|EG000|Reported Event|Methergine|
10961071|NCT00858832|EG001|Reported Event|No Methergine|
10961072|NCT00858845|BG000|Baseline|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
10961073|NCT00858845|BG001|Baseline|Placebo Patch|Participants were assigned to wear a matching placebo patch (0.1 mg/weekly) for a treatment period of 3 months.
10961074|NCT00858845|BG002|Baseline|Total|Total of all reporting groups
10961075|NCT00858845|FG000|Participant Flow|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
10961076|NCT00858845|FG001|Participant Flow|Placebo|Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months.
10961077|NCT00858845|OG000|Outcome|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
11179746|NCT02057835|OG008|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179747|NCT02057835|OG009|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179748|NCT02057835|OG000|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11234465|NCT02435524|BG000|Baseline|A&T Intervention Communes: Baseline|"Communes where the A&T infant and young child feeding intervention was implemented:~Interpersonal communication delivered by community workers and volunteers during home visits and at monthly mother's group meetings to:~Increase mother's knowledge about optimal breastfeeding and its benefits~Increase mother's self-efficacy related to breastfeeding~Improve mother's perceptions about social norms relating to breastfeeding~Community mobilisation activities to:~- Raise awareness of the benefits of optimal breastfeeding among opinion leaders, and family members, and increase the support they provide to breastfeeding mothers~Enhanced training of government health workers in infant and young child feeding to:~Improve their ability to support mothers and provide timely information about infant feeding"
11234466|NCT02435524|BG001|Baseline|Control Communes: Baseline|No intervention
11234467|NCT02435524|BG002|Baseline|A&T Intervention Communes: Endline|"Communes where the A&T infant and young child feeding intervention was implemented:~Interpersonal communication delivered by community workers and volunteers during home visits and at monthly mother's group meetings to:~Increase mother's knowledge about optimal breastfeeding and its benefits~Increase mother's self-efficacy related to breastfeeding~Improve mother's perceptions about social norms relating to breastfeeding~Community mobilisation activities to:~- Raise awareness of the benefits of optimal breastfeeding among opinion leaders, and family members, and increase the support they provide to breastfeeding mothers~Enhanced training of government health workers in infant and young child feeding to:~Improve their ability to support mothers and provide timely information about infant feeding"
11234468|NCT02435524|BG003|Baseline|Control Communes: Endline|No intervention
11234469|NCT02435524|BG004|Baseline|Total|Total of all reporting groups
11234470|NCT02435524|FG000|Participant Flow|A&T Intervention Communes|"Communes where the A&T infant and young child feeding intervention was implemented:~Interpersonal communication delivered by community workers and volunteers during home visits and at monthly mother's group meetings to:~Increase mother's knowledge about optimal breastfeeding and its benefits~Increase mother's self-efficacy related to breastfeeding~Improve mother's perceptions about social norms relating to breastfeeding~Community mobilisation activities to:~- Raise awareness of the benefits of optimal breastfeeding among opinion leaders, and family members, and increase the support they provide to breastfeeding mothers~Enhanced training of government health workers in infant and young child feeding to:~Improve their ability to support mothers and provide timely information about infant feeding"
11234471|NCT02435524|FG001|Participant Flow|Control Communes|No intervention
11234472|NCT02435524|OG000|Outcome|A&T Intervention Communes|"Communes where the A&T infant and young child feeding intervention was implemented:~Interpersonal communication delivered by community workers and volunteers during home visits and at monthly mother's group meetings to:~Increase mother's knowledge about optimal breastfeeding and its benefits~Increase mother's self-efficacy related to breastfeeding~Improve mother's perceptions about social norms relating to breastfeeding~Community mobilisation activities to:~- Raise awareness of the benefits of optimal breastfeeding among opinion leaders, and family members, and increase the support they provide to breastfeeding mothers~Enhanced training of government health workers in infant and young child feeding to:~Improve their ability to support mothers and provide timely information about infant feeding"
11234473|NCT02435524|OG001|Outcome|Control Communes|No intervention
10961078|NCT00858845|OG001|Outcome|Placebo|Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
10961079|NCT00858845|EG000|Reported Event|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
10961080|NCT00858845|EG001|Reported Event|Placebo|Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months.
10961081|NCT00858858|BG000|Baseline|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
10961082|NCT00858858|FG000|Participant Flow|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
10961083|NCT00858858|OG000|Outcome|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
11341785|NCT03688542|BG000|Baseline|Intervention|"Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy.~Quality Circle Deprescribing Module: The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus.."
10961084|NCT00858858|EG000|Reported Event|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
10961085|NCT00858962|BG000|Baseline|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
10961086|NCT00858962|FG000|Participant Flow|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
10961087|NCT00858962|OG000|Outcome|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
10961088|NCT00858962|EG000|Reported Event|Bup/Ral|HIV negative subjects currently enrolled in Buprenorphine maintenance therapy on a stable dose of BUP for at least 3 weeks were admitted to the HRU for PK sampling at intervals over a 24 hour period. Subjects then received RAL and BUP co-administration for a minimum of 4 days after which a second series of blood draws at intervals over a 24 hour period were conducted.
10961089|NCT00858988|BG000|Baseline|Rifaximin|Allocated to rifaximin
10961090|NCT00858988|BG001|Baseline|Placebo|Allocated to placebo
10961091|NCT00858988|BG002|Baseline|Total|Total of all reporting groups
10961092|NCT00858988|FG000|Participant Flow|Rifaximin|Allocated to rifaximin
10961093|NCT00858988|FG001|Participant Flow|Placebo|Allocated to placebo
10961094|NCT00858988|OG000|Outcome|Rifaximin|Allocated to rifaximin
10961095|NCT00858988|OG001|Outcome|Placebo|Allocated to placebo
10961096|NCT00858988|EG000|Reported Event|Rifaximin|Allocated to rifaximin
10961097|NCT00858988|EG001|Reported Event|Placebo|Allocated to placebo
10961098|NCT00859014|BG000|Baseline|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
11341786|NCT03688542|BG001|Baseline|Control|Nursing Homes allocated to the Control arm will not enact the intervention.
11341787|NCT03688542|BG002|Baseline|Total|Total of all reporting groups
10961099|NCT00859014|FG000|Participant Flow|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
10961100|NCT00859014|OG000|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
10961101|NCT00859014|EG000|Reported Event|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
10961102|NCT00859027|BG000|Baseline|Risedronate Plus Calcium and Vit D|
10961103|NCT00859027|BG001|Baseline|Calcium and Vitamin D|
10961104|NCT00859027|BG002|Baseline|Total|Total of all reporting groups
10961105|NCT00859027|FG000|Participant Flow|Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily|"Pts receiving LHRH-agonists for prostate cancer received active risedronate.~They also received daily calcium + Vit D"
10961106|NCT00859027|FG001|Participant Flow|Calcium and Vitamin D Daily (Placebo Group)|Pts received placebo risedronate + calcium and Vit D.
10961107|NCT00859027|OG000|Outcome|Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily|
10961108|NCT00859027|OG001|Outcome|Calcium and Vitamin D Daily (Placebo Group)|
10961109|NCT00859027|EG000|Reported Event|Calcium and Vitamin D|
10961110|NCT00859027|EG001|Reported Event|Risedronate|Particiapnts given 35 mg by mouth every week
10961111|NCT00859040|BG000|Baseline|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
10961112|NCT00859040|BG001|Baseline|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
10961113|NCT00859040|BG002|Baseline|Total|Total of all reporting groups
10961114|NCT00859040|FG000|Participant Flow|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
10961115|NCT00859040|FG001|Participant Flow|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
10961116|NCT00859040|OG000|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
10961117|NCT00859040|OG001|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
10961118|NCT00859040|OG000|Outcome|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
10961119|NCT00859040|EG000|Reported Event|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
10961120|NCT00859053|BG000|Baseline|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961121|NCT00859053|BG001|Baseline|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961122|NCT00859053|BG002|Baseline|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961123|NCT00859053|BG003|Baseline|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961124|NCT00859053|BG004|Baseline|Total|Total of all reporting groups
10961125|NCT00859053|FG000|Participant Flow|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 milligrams (mg) (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961126|NCT00859053|FG001|Participant Flow|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961127|NCT00859053|FG002|Participant Flow|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961128|NCT00859053|FG003|Participant Flow|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961129|NCT00859053|OG000|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961130|NCT00859053|OG001|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961131|NCT00859053|OG002|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961132|NCT00859053|OG003|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961133|NCT00859053|EG000|Reported Event|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961134|NCT00859053|EG001|Reported Event|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961135|NCT00859053|EG002|Reported Event|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961136|NCT00859053|EG003|Reported Event|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
10961137|NCT00859131|BG000|Baseline|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
10961138|NCT00859131|BG001|Baseline|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
10961139|NCT00859131|BG002|Baseline|Total|Total of all reporting groups
10961140|NCT00859131|FG000|Participant Flow|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
10961141|NCT00859131|FG001|Participant Flow|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
10961142|NCT00859131|OG000|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
10961143|NCT00859131|OG001|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
10961144|NCT00859131|EG000|Reported Event|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
10961145|NCT00859131|EG001|Reported Event|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
10961146|NCT00859222|BG000|Baseline|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
10961147|NCT00859222|BG001|Baseline|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961148|NCT00859222|BG002|Baseline|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961149|NCT00859222|BG003|Baseline|Total|Total of all reporting groups
10961150|NCT00859222|FG000|Participant Flow|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
10961151|NCT00859222|FG001|Participant Flow|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961152|NCT00859222|FG002|Participant Flow|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961153|NCT00859222|FG003|Participant Flow|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961154|NCT00859222|FG004|Participant Flow|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961155|NCT00859222|OG000|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
10961156|NCT00859222|OG000|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
10961157|NCT00859222|OG001|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961158|NCT00859222|OG002|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961159|NCT00859222|OG000|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961160|NCT00859222|OG001|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961161|NCT00859222|OG003|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961162|NCT00859222|OG004|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961163|NCT00859222|EG000|Reported Event|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
10961164|NCT00859222|EG001|Reported Event|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961165|NCT00859222|EG002|Reported Event|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961166|NCT00859222|EG003|Reported Event|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961167|NCT00859222|EG004|Reported Event|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
10961168|NCT00859313|BG000|Baseline|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
10961169|NCT00859313|FG000|Participant Flow|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
10961170|NCT00859313|OG000|Outcome|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
10961171|NCT00859313|EG000|Reported Event|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
10961172|NCT00859339|BG000|Baseline|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
10961173|NCT00859339|FG000|Participant Flow|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
10961174|NCT00859339|OG000|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
10961175|NCT00859339|EG000|Reported Event|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
10961176|NCT00859456|BG000|Baseline|Sunitinib|"Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens.~Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.~A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs)."
10961177|NCT00859456|FG000|Participant Flow|Sunitinib|"Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens.~Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.~A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs)."
10961178|NCT00859456|OG000|Outcome|Sunitinib|"Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens.~Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.~A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs)."
10961179|NCT00859456|EG000|Reported Event|Sunitinib|"Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens.~Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.~A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs)."
10961180|NCT00859469|BG000|Baseline|Oxaliplatin and Gemcitabine|The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
10961181|NCT00859469|FG000|Participant Flow|Oxaliplatin and Gemcitabine|The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
10961182|NCT00859469|OG000|Outcome|Oxaliplatin and Gemcitabine|The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
10961183|NCT00859469|EG000|Reported Event|Oxaliplatin and Gemcitabine|The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
10961184|NCT00859495|BG000|Baseline|Multimodal Lung Sparing Regimen|"Intrapleural chemotherapy plus systemic chemotherapy:~Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.~Doxorubicin: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.~Cisplatin: Platinum-based antineoplastic~Pemetrexed: Folate Analog Metabolic Inhibitor~Radiotherapy: Standard procedure given 3 weeks after last dose of chemotherapy"
11179749|NCT02057835|OG001|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179750|NCT02057835|OG002|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179751|NCT02057835|OG003|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961185|NCT00859495|FG000|Participant Flow|Multimodal Lung Sparing Regimen|"Intrapleural chemotherapy plus systemic chemotherapy:~Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.~Doxorubicin: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.~Cisplatin: Platinum-based antineoplastic~Pemetrexed: Folate Analog Metabolic Inhibitor~Radiotherapy: Standard procedure given 3 weeks after last dose of chemotherapy"
10961186|NCT00859495|OG000|Outcome|Multimodal Lung Sparing Regimen|"Intrapleural chemotherapy plus systemic chemotherapy:~Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.~Doxorubicin: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.~Cisplatin: Platinum-based antineoplastic~Pemetrexed: Folate Analog Metabolic Inhibitor~Radiotherapy: Standard procedure given 3 weeks after last dose of chemotherapy"
10961187|NCT00859495|EG000|Reported Event|Multimodal Lung Sparing Regimen|"Intrapleural chemotherapy plus systemic chemotherapy:~Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.~Doxorubicin: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.~Cisplatin: Platinum-based antineoplastic~Pemetrexed: Folate Analog Metabolic Inhibitor~Radiotherapy: Standard procedure given 3 weeks after last dose of chemotherapy"
10961188|NCT00859508|BG000|Baseline|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
10961189|NCT00859508|BG001|Baseline|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
10961190|NCT00859508|BG002|Baseline|Total|Total of all reporting groups
10961191|NCT00859508|FG000|Participant Flow|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
10961192|NCT00859508|FG001|Participant Flow|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
10961193|NCT00859508|OG000|Outcome|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
10961194|NCT00859508|OG001|Outcome|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
10961195|NCT00859508|EG000|Reported Event|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
10961196|NCT00859508|EG001|Reported Event|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
10963878|NCT00874770|FG000|Participant Flow|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10963879|NCT00874770|FG001|Participant Flow|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10963880|NCT00874770|FG002|Participant Flow|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10963881|NCT00874770|FG003|Participant Flow|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10963882|NCT00874770|OG000|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10963883|NCT00874770|OG001|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11179752|NCT02057835|OG004|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179753|NCT02057835|OG005|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179754|NCT02057835|OG006|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961197|NCT00859547|BG000|Baseline|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
10961198|NCT00859547|FG000|Participant Flow|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
10961199|NCT00859547|OG000|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
10961200|NCT00859547|EG000|Reported Event|TOTAL|
10961201|NCT00859573|BG000|Baseline|Modafinil|Modafinil 400mg orally once daily
10961202|NCT00859573|BG001|Baseline|Placebo|Two placebo tablets orally once daily
10961203|NCT00859573|BG002|Baseline|Total|Total of all reporting groups
10961204|NCT00859573|FG000|Participant Flow|Modafinil|Modafinil 400mg orally once daily
10961205|NCT00859573|FG001|Participant Flow|Placebo|Two placebo tablets orally once daily
10961206|NCT00859573|OG000|Outcome|Placebo|Participants received 2 capsules placebo orally daily
10961207|NCT00859573|OG001|Outcome|Modafinil|Modafinil 400mg orally daily
10961208|NCT00859573|EG000|Reported Event|Modafinil|Modafinil 400mg orally once daily
10961209|NCT00859573|EG001|Reported Event|Placebo|Two placebo tablets orally once daily
10961210|NCT00859586|BG000|Baseline|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
10961211|NCT00859586|FG000|Participant Flow|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
10961212|NCT00859586|OG000|Outcome|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
10961213|NCT00859586|EG000|Reported Event|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
10961214|NCT00859638|BG000|Baseline|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
10961215|NCT00859638|BG001|Baseline|Case Matched Controls|Usual care in primary health care.
10961216|NCT00859638|BG002|Baseline|Total|Total of all reporting groups
10961217|NCT00859638|FG000|Participant Flow|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
10961218|NCT00859638|FG001|Participant Flow|Case Matched Controls|Usual care in primary health care.
10961219|NCT00859638|OG000|Outcome|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
10961220|NCT00859638|OG001|Outcome|Case Matched Controls|Usual care in primary health care.
10961221|NCT00859638|EG000|Reported Event|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
10961222|NCT00859638|EG001|Reported Event|Case Matched Controls|Usual care in primary health care.
10961223|NCT00859651|BG000|Baseline|Cholecalciferol 20,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
10961224|NCT00859651|BG001|Baseline|Cholecalciferol 30,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
10961225|NCT00859651|BG002|Baseline|Total|Total of all reporting groups
10961226|NCT00859651|FG000|Participant Flow|Cholecalciferol 20,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
10961227|NCT00859651|FG001|Participant Flow|Cholecalciferol 30,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
10961228|NCT00859651|OG000|Outcome|Cholecalciferol 20,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
10961229|NCT00859651|OG001|Outcome|Cholecalciferol 30,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
10961230|NCT00859651|EG000|Reported Event|Cholecalciferol 20,000 IU|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
10961231|NCT00859651|EG001|Reported Event|Cholecalciferol 30,000 IU|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
10961232|NCT00859833|BG000|Baseline|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
10961233|NCT00859833|FG000|Participant Flow|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson was given (0.4 mg) given as in i.v. bolus.
10961234|NCT00859833|OG000|Outcome|Adenosine|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes).
10961235|NCT00859833|OG001|Outcome|Regadenoson|Regadenoson 0.5 mg i.v. bolus.
10961236|NCT00859833|EG000|Reported Event|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
10961237|NCT00859898|BG000|Baseline|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
11179755|NCT02057835|OG007|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961238|NCT00859898|BG001|Baseline|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
10961239|NCT00859898|BG002|Baseline|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
10961240|NCT00859898|BG003|Baseline|Total|Total of all reporting groups
10961241|NCT00859898|FG000|Participant Flow|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
10961242|NCT00859898|FG001|Participant Flow|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.~Placebo: Metformin hydrochloride (HCl) Modified Release matching placebo tablets, once daily, 24 weeks."
11179756|NCT02057835|OG000|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179757|NCT02057835|OG001|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961243|NCT00859898|FG002|Participant Flow|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
10961244|NCT00859898|OG000|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
10961245|NCT00859898|OG001|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
10961246|NCT00859898|OG002|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
10961247|NCT00859898|OG001|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
10961248|NCT00859898|EG000|Reported Event|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
10961249|NCT00859898|EG001|Reported Event|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
10961250|NCT00859898|EG002|Reported Event|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
10961251|NCT00859937|BG000|Baseline|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961252|NCT00859937|BG001|Baseline|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961253|NCT00859937|BG002|Baseline|Total|Total of all reporting groups
10961254|NCT00859937|FG000|Participant Flow|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961255|NCT00859937|FG001|Participant Flow|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961256|NCT00859937|OG000|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11179758|NCT02057835|OG002|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179759|NCT02057835|OG003|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179760|NCT02057835|EG000|Reported Event|Placebo|Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
11179761|NCT02057835|EG001|Reported Event|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
10961257|NCT00859937|OG001|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11179762|NCT02057835|EG002|Reported Event|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179763|NCT02057835|EG003|Reported Event|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179764|NCT02057835|EG004|Reported Event|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
11179765|NCT02057939|BG000|Baseline|Enzalutamide|"Enzalutamide, Androgen Deprivation, and Radiation Therapy~enzalutamide: 160 mg orally once daily for six months~Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.~Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy"
11179766|NCT02057939|FG000|Participant Flow|Enzalutamide|"Enzalutamide, Androgen Deprivation, and Radiation Therapy~enzalutamide: 160 mg orally once daily for six months~Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.~Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy"
11179767|NCT02057939|OG000|Outcome|Enzalutamide|"Enzalutamide, Androgen Deprivation, and Radiation Therapy~enzalutamide: 160 mg orally once daily for six months~Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.~Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy"
11179768|NCT02057939|EG000|Reported Event|Enzalutamide|"Enzalutamide, Androgen Deprivation, and Radiation Therapy~enzalutamide: 160 mg orally once daily for six months~Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.~Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy"
11179769|NCT02057952|BG000|Baseline|Usual Care Control|No intervention.
11179770|NCT02057952|BG001|Baseline|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
11179771|NCT02057952|BG002|Baseline|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
11179772|NCT02057952|BG003|Baseline|Total|Total of all reporting groups
11179773|NCT02057952|FG000|Participant Flow|Usual Care Control|No intervention.
11179774|NCT02057952|FG001|Participant Flow|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
11179775|NCT02057952|FG002|Participant Flow|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
11179776|NCT02057952|OG000|Outcome|Usual Care Control|No intervention.
11179777|NCT02057952|OG001|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
11179778|NCT02057952|OG002|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
11179779|NCT02057952|EG000|Reported Event|Usual Care Control|No intervention.
11179780|NCT02057952|EG001|Reported Event|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
10961258|NCT00859937|EG000|Reported Event|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11179781|NCT02057952|EG002|Reported Event|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
11179782|NCT02058069|BG000|Baseline|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
11179783|NCT02058069|FG000|Participant Flow|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.~Participants throughout this posting is equivalent to the number of knees."
11179784|NCT02058069|OG000|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
11179785|NCT02058069|EG000|Reported Event|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.~Note regarding serious AEs:~Adhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient's overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device."
11179786|NCT02058095|BG000|Baseline|Tadalafil|"Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
11179787|NCT02058095|BG001|Baseline|Placebo|"Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
11179788|NCT02058095|BG002|Baseline|Total|Total of all reporting groups
11179789|NCT02058095|FG000|Participant Flow|Tadalafil|"Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
11179790|NCT02058095|FG001|Participant Flow|Placebo|"Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
10961259|NCT00859937|EG001|Reported Event|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961260|NCT00859950|BG000|Baseline|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
10961261|NCT00859950|BG001|Baseline|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
10961262|NCT00859950|BG002|Baseline|Total|Total of all reporting groups
11179791|NCT02058095|OG000|Outcome|Tadalafil|"Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
10961263|NCT00859950|FG000|Participant Flow|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
10961264|NCT00859950|FG001|Participant Flow|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
10961265|NCT00859950|OG000|Outcome|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
11179792|NCT02058095|OG001|Outcome|Placebo|"Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
10961266|NCT00859950|OG001|Outcome|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
10961267|NCT00859950|EG000|Reported Event|Normal Control|"Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.~Serious and Other [Not Including Serious] Adverse Events were not observed."
10961268|NCT00859950|EG001|Reported Event|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw.~Serious and Other [Not Including Serious] Adverse Events were not observed."
10961269|NCT00859976|BG000|Baseline|Plasma-sprayed Shell|"Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.~Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell"
10961270|NCT00859976|BG001|Baseline|BoneMaster Coated Shell|"Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.~BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell"
10961271|NCT00859976|BG002|Baseline|Total|Total of all reporting groups
10961272|NCT00859976|FG000|Participant Flow|Plasma-sprayed Shell|"Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.~Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell"
10961273|NCT00859976|FG001|Participant Flow|BoneMaster Coated Shell|"Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.~BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell"
10961274|NCT00859976|OG000|Outcome|Plasma-sprayed Shell|"Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.~Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell"
10961275|NCT00859976|OG001|Outcome|BoneMaster Coated Shell|"Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.~BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell"
10961276|NCT00859976|EG000|Reported Event|Plasma-sprayed Shell|"Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.~Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell"
10961277|NCT00859976|EG001|Reported Event|BoneMaster Coated Shell|"Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.~BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell"
10961278|NCT00860015|BG000|Baseline|Alimta/Gemcitabine|"IV administration of drugs for 14 days for up to 4 cycles~Alimta: 500 mg/m2 via IV over 10 minutes~A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.~Gemcitabine: 1000 mg/m2 via IV over 90 minutes~A nucleoside analog used as chemotherapy."
10961279|NCT00860015|FG000|Participant Flow|Alimta/Gemcitabine|"IV administration of drugs for 14 days for up to 4 cycles~Alimta: 500 mg/m2 via IV over 10 minutes~A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.~Gemcitabine: 1000 mg/m2 via IV over 90 minutes~A nucleoside analog used as chemotherapy."
10961280|NCT00860015|OG000|Outcome|Alimta/Gemcitabine|"IV administration of drugs for 14 days for up to 4 cycles~Alimta: 500 mg/m2 via IV over 10 minutes~A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.~Gemcitabine: 1000 mg/m2 via IV over 90 minutes~A nucleoside analog used as chemotherapy."
10961281|NCT00860015|EG000|Reported Event|Alimta/Gemcitabine|"IV administration of drugs for 14 days for up to 4 cycles~Alimta: 500 mg/m2 via IV over 10 minutes~A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.~Gemcitabine: 1000 mg/m2 via IV over 90 minutes~A nucleoside analog used as chemotherapy."
11179793|NCT02058095|EG000|Reported Event|Tadalafil|"Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
10961282|NCT00860028|BG000|Baseline|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
10961283|NCT00860028|BG001|Baseline|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
10961284|NCT00860028|BG002|Baseline|Total|Total of all reporting groups
10961285|NCT00860028|FG000|Participant Flow|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
10961286|NCT00860028|FG001|Participant Flow|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
10961287|NCT00860028|OG000|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
10961288|NCT00860028|OG001|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
11179794|NCT02058095|EG001|Reported Event|Placebo|"Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
11179795|NCT02058108|BG000|Baseline|Telbivudine|Patients of any age and weight< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily
11179796|NCT02058108|BG001|Baseline|Placebo|Patients of any age and weight < 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
11179797|NCT02058108|BG002|Baseline|Total|Total of all reporting groups
11179798|NCT02058108|FG000|Participant Flow|Telbivudine|Patients of any age and weight< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily
11179799|NCT02058108|FG001|Participant Flow|Placebo|Patients of any age and weight < 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
11179800|NCT02058108|OG000|Outcome|Telbivudine|Patients of any age and weight< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily
11179801|NCT02058108|OG001|Outcome|Placebo|Patients of any age and weight < 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
11179802|NCT02058108|EG000|Reported Event|Initial LdT (Telbivudine)|Patients of any age and weight< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily
11179803|NCT02058108|EG001|Reported Event|Initial Placebo on Placebo Treatment|Initial Placebo patients who did not switched to LdT treatment
10961289|NCT00860028|OG000|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date.
10961290|NCT00860028|OG001|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date
10961291|NCT00860028|EG000|Reported Event|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
11179804|NCT02058108|EG002|Reported Event|Initial Placebo on LdT Treatment After Switching|Initial Placebo patients who switched to LdT treatment
11179805|NCT02058108|EG003|Reported Event|All Ldt|Initial LdT and Initial Placebo on LdT treatment after switching combined
10961292|NCT00860028|EG001|Reported Event|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
10961293|NCT00860067|BG000|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
10961294|NCT00860067|BG001|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
10961295|NCT00860067|BG002|Baseline|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
10961296|NCT00860067|BG003|Baseline|Total|Total of all reporting groups
11179806|NCT02058147|BG000|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179807|NCT02058147|BG001|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
10961297|NCT00860067|FG000|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
11179808|NCT02058147|BG002|Baseline|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
11179809|NCT02058147|BG003|Baseline|Total|Total of all reporting groups
11179810|NCT02058147|FG000|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
11179811|NCT02058147|FG001|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179812|NCT02058147|FG002|Participant Flow|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
11179813|NCT02058147|OG000|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179814|NCT02058147|OG001|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179815|NCT02058147|OG002|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
11179816|NCT02058147|EG000|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
11179817|NCT02058147|EG001|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
11179818|NCT02058147|EG002|Reported Event|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose) median exposure: 211 days).
11179819|NCT02058160|BG000|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179820|NCT02058160|BG001|Baseline|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179821|NCT02058160|BG002|Baseline|Total|Total of all reporting groups
11179822|NCT02058160|FG000|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
11179823|NCT02058160|FG001|Participant Flow|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179824|NCT02058160|OG000|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179825|NCT02058160|OG001|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
11179826|NCT02058160|EG000|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
11179827|NCT02058160|EG001|Reported Event|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 210 days).
11179828|NCT02058251|BG000|Baseline|Oxytocin|"Each participant will self-administer a 40 IU dose of intranasal oxytocin.~Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants."
11179829|NCT02058251|BG001|Baseline|Control|"Each participant will self-administer a 40 IU dose of intranasal saline.~Placebo: Each participant will self-administer a 40 IU dose of intranasal saline."
11179830|NCT02058251|BG002|Baseline|Total|Total of all reporting groups
11179831|NCT02058251|FG000|Participant Flow|Oxytocin|"Each participant will self-administer a 40 IU dose of intranasal oxytocin.~Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants."
11179832|NCT02058251|FG001|Participant Flow|Control|"Each participant will self-administer a 40 IU dose of intranasal saline.~Placebo: Each participant will self-administer a 40 IU dose of intranasal saline."
11179833|NCT02058251|OG000|Outcome|Oxytocin|"Each participant will self-administer a 40 IU dose of intranasal oxytocin.~Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants."
11179834|NCT02058251|OG001|Outcome|Control|"Each participant will self-administer a 40 IU dose of intranasal saline.~Placebo: Each participant will self-administer a 40 IU dose of intranasal saline."
11179835|NCT02058251|EG000|Reported Event|Oxytocin|"Each participant will self-administer a 40 IU dose of intranasal oxytocin.~Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants."
11179836|NCT02058251|EG001|Reported Event|Control|"Each participant will self-administer a 40 IU dose of intranasal saline.~Placebo: Each participant will self-administer a 40 IU dose of intranasal saline."
11179837|NCT02058290|BG000|Baseline|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
11179838|NCT02058290|BG001|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
11179839|NCT02058290|BG002|Baseline|Total|Total of all reporting groups
10961298|NCT00860067|FG001|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
11179840|NCT02058290|FG000|Participant Flow|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
11179841|NCT02058290|FG001|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
11179842|NCT02058290|OG000|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
11179843|NCT02058290|OG001|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
11179844|NCT02058290|EG000|Reported Event|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
11179845|NCT02058290|EG001|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
11179846|NCT02058368|BG000|Baseline|Placebo + Tam 0.2mg|Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
11179847|NCT02058368|BG001|Baseline|Dut 0.5 mg + Tam 0.2 mg|Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
11179848|NCT02058368|BG002|Baseline|Total|Total of all reporting groups
10961299|NCT00860067|FG002|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
11179849|NCT02058368|FG000|Participant Flow|Placebo +Tam 0.2mg|Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
11179850|NCT02058368|FG001|Participant Flow|Dut 0.5 mg + Tam 0.2 mg|Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
11179851|NCT02058368|OG000|Outcome|Placebo + Tam 0.2mg|Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
11179852|NCT02058368|OG001|Outcome|Dut 0.5 mg + Tam 0.2 mg|Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
11179853|NCT02058368|EG000|Reported Event|Placebo + Tam 0.2mg|Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
11179854|NCT02058368|EG001|Reported Event|Dut 0.5 mg + Tam 0.2 mg|Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
11179855|NCT02058498|BG000|Baseline|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
11179856|NCT02058498|FG000|Participant Flow|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
11179857|NCT02058498|OG000|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
10961300|NCT00860067|OG000|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
10961301|NCT00860067|OG001|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
10961302|NCT00860067|OG002|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
10961303|NCT00860067|OG003|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
10961304|NCT00860067|OG001|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
10961305|NCT00860067|OG001|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
10961306|NCT00860067|OG001|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
10961307|NCT00860067|EG000|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
10961308|NCT00860067|EG001|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
10961309|NCT00860171|BG000|Baseline|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10961310|NCT00860171|FG000|Participant Flow|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10961311|NCT00860171|OG000|Outcome|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10961312|NCT00860171|EG000|Reported Event|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10961313|NCT00860262|BG000|Baseline|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
10961314|NCT00860262|BG001|Baseline|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
10961315|NCT00860262|BG002|Baseline|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
10961316|NCT00860262|BG003|Baseline|Total|Total of all reporting groups
10961317|NCT00860262|FG000|Participant Flow|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
10961318|NCT00860262|FG001|Participant Flow|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
10961319|NCT00860262|FG002|Participant Flow|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
10961320|NCT00860262|OG000|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
10961321|NCT00860262|OG001|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
10961322|NCT00860262|OG002|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
10961323|NCT00860262|OG000|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
10961324|NCT00860262|OG002|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
10961325|NCT00860262|EG000|Reported Event|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
10961326|NCT00860262|EG001|Reported Event|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
10961327|NCT00860262|EG002|Reported Event|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
10961328|NCT00860314|BG000|Baseline|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
10961329|NCT00860314|BG001|Baseline|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
10961330|NCT00860314|BG002|Baseline|Total|Total of all reporting groups
10961331|NCT00860314|FG000|Participant Flow|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
10961332|NCT00860314|FG001|Participant Flow|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
11234474|NCT02435524|EG000|Reported Event|A&T Intervention Communes|"Communes where the A&T infant and young child feeding intervention was implemented:~Interpersonal communication delivered by community workers and volunteers during home visits and at monthly mother's group meetings to:~Increase mother's knowledge about optimal breastfeeding and its benefits~Increase mother's self-efficacy related to breastfeeding~Improve mother's perceptions about social norms relating to breastfeeding~Community mobilisation activities to:~- Raise awareness of the benefits of optimal breastfeeding among opinion leaders, and family members, and increase the support they provide to breastfeeding mothers~Enhanced training of government health workers in infant and young child feeding to:~Improve their ability to support mothers and provide timely information about infant feeding"
11234475|NCT02435524|EG001|Reported Event|Control Communes|No intervention
11234476|NCT02435680|BG000|Baseline|MCS110+Carboplatin+Gemcitabine|experimental. MCS110 10mg/kg intravenous infusion on day 1.
11234477|NCT02435680|BG001|Baseline|MCS110 With C1D8 Dose + Carboplatin +Gemcitabine|experimental.MCS110 10mg/kg intravenous infusion on days 1 & 8
10961333|NCT00860314|OG000|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
11234478|NCT02435680|BG002|Baseline|Carboplatin+Gemcitabine|comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 & 8 Carboplatin: Intravenous infusion AUC 2 Days 1 & 8
11234479|NCT02435680|BG003|Baseline|Total|Total of all reporting groups
10961334|NCT00860314|OG001|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
10961335|NCT00860314|EG000|Reported Event|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
10961336|NCT00860314|EG001|Reported Event|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
10961337|NCT00860379|BG000|Baseline|Placebo|"Placebo~Placebo: IV saline as placebo"
10961338|NCT00860379|BG001|Baseline|Selenium1|"Subject will receive 2 ug/kg of IV selenium per day~Selenium1: 2 ug/kg"
10961339|NCT00860379|BG002|Baseline|Selenium2|"Subject will receive 4 ug/kg of IV selenium per day~Selenium2: 4 ug/kg"
10961340|NCT00860379|BG003|Baseline|Total|Total of all reporting groups
10961341|NCT00860379|FG000|Participant Flow|Placebo|"Placebo~Placebo: IV saline as placebo"
10961342|NCT00860379|FG001|Participant Flow|Selenium 2 ug/kg|"Subject will receive 2 ug/kg of IV selenium per day~Selenium1: 2 ug/kg"
10961343|NCT00860379|FG002|Participant Flow|Selenium 4 ug/kg|"Subject will receive 4 ug/kg of IV selenium per day~Selenium2: 4 ug/kg"
10961344|NCT00860379|OG000|Outcome|Placebo|"Placebo~Placebo: IV saline as placebo"
10961345|NCT00860379|OG001|Outcome|Selenium1|"Subject will receive 2 ug/kg of IV selenium per day~Selenium1: 2 ug/kg"
10961346|NCT00860379|OG002|Outcome|Selenium2|"Subject will receive 4 ug/kg of IV selenium per day~Selenium2: 4 ug/kg"
10961347|NCT00860379|EG000|Reported Event|Placebo|"Placebo~Placebo: IV saline as placebo"
10961348|NCT00860379|EG001|Reported Event|Selenium1|"Subject will receive 2 ug/kg of IV selenium per day~Selenium1: 2 ug/kg"
10961349|NCT00860379|EG002|Reported Event|Selenium2|"Subject will receive 4 ug/kg of IV selenium per day~Selenium2: 4 ug/kg"
10961350|NCT00860405|BG000|Baseline|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
10961351|NCT00860405|BG001|Baseline|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
10961352|NCT00860405|BG002|Baseline|Total|Total of all reporting groups
10961353|NCT00860405|FG000|Participant Flow|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
10961354|NCT00860405|FG001|Participant Flow|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
10961355|NCT00860405|OG000|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
11234480|NCT02435680|FG000|Participant Flow|MCS110+Carboplatin+Gemcitabine|experimental. MCS110 10mg/kg intravenous infusion on day 1.
10961356|NCT00860405|OG001|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
10961357|NCT00860405|EG000|Reported Event|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
10961358|NCT00860405|EG001|Reported Event|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
10961359|NCT00860457|BG000|Baseline|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
10961360|NCT00860457|FG000|Participant Flow|Chemotherapy|Fludarabine/Rituximab followed by Lenalidomide
10961361|NCT00860457|OG000|Outcome|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
11234481|NCT02435680|FG001|Participant Flow|MCS110 With C1D8 Dose+Carboplatin+Gemcitabine|experimental.MCS110 10mg/kg intravenous infusion on day 1 and day 8
11234482|NCT02435680|FG002|Participant Flow|Carboplatin+Gemcitabine|comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 & 8 Carboplatin: Intravenous infusion AUC 2 Days 1 & 8
11234483|NCT02435680|OG000|Outcome|All MCS110+Carboplatin+Gemcitabine|experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 & 8
11179858|NCT02058498|EG000|Reported Event|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
11179859|NCT02058511|BG000|Baseline|Intervention Group|"all enrolled patients undergo the same protocol/ treatment:~Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs~Anesthesia Premedication, Induction and Maintenance: The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants.~The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain.~Pupillometry after administration of anesthetic drugs: All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded.~Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period~The administered drugs are:~Midazolam 1-2 mg"
11179860|NCT02058511|FG000|Participant Flow|Intervention Group|"all enrolled patients undergo the same protocol/ treatment:~Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs~Anesthesia Premedication, Induction and Maintenance: The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants.~The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain.~Pupillometry after administration of anesthetic drugs: All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded.~Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period~The administered drugs are:~Midazolam 1-2 mg"
11179861|NCT02058511|OG000|Outcome|Intervention Group|"all enrolled patients undergo the same protocol/ treatment:~Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs~Anesthesia Premedication, Induction and Maintenance: The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants.~The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain.~Pupillometry after administration of anesthetic drugs: All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded.~Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period~The administered drugs are:~Midazolam 1-2 mg"
11179862|NCT02058511|EG000|Reported Event|Intervention Group|"all enrolled patients undergo the same protocol/ treatment:~Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs"
11179863|NCT02058563|BG000|Baseline|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
11179864|NCT02058563|BG001|Baseline|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11179865|NCT02058563|BG002|Baseline|Total|Total of all reporting groups
11179866|NCT02058563|FG000|Participant Flow|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
11179867|NCT02058563|FG001|Participant Flow|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11179868|NCT02058563|OG000|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
11179869|NCT02058563|OG001|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11179870|NCT02058563|EG000|Reported Event|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
11179871|NCT02058563|EG001|Reported Event|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
11179872|NCT02058589|BG000|Baseline|GSK1437173A Group|Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
11179873|NCT02058589|BG001|Baseline|Control Group|Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
11179874|NCT02058589|BG002|Baseline|Total|Total of all reporting groups
11179875|NCT02058589|FG000|Participant Flow|GSK1437173A Group|Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
11179876|NCT02058589|FG001|Participant Flow|Control Group|Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
11179877|NCT02058589|OG000|Outcome|GSK1437173A Group|Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
11179878|NCT02058589|OG001|Outcome|Control Group|Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
11179879|NCT02058589|OG000|Outcome|GSK1437173A Group|Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of the non-dominant arm.
11179880|NCT02058589|OG001|Outcome|Control Group|Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of the non-dominant arm.
10961362|NCT00860457|EG000|Reported Event|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
10961363|NCT00860470|BG000|Baseline|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
10961364|NCT00860470|BG001|Baseline|Multiple Micronutrient|"Multiple micronutrient~Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
10961365|NCT00860470|BG002|Baseline|Total|Total of all reporting groups
10961366|NCT00860470|FG000|Participant Flow|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
10961367|NCT00860470|FG001|Participant Flow|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
10961368|NCT00860470|OG000|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
10961369|NCT00860470|OG001|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
10961370|NCT00860470|EG000|Reported Event|Iron (27 mg) and Folic Acid (600 ug)|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
10961371|NCT00860470|EG001|Reported Event|Multiple Micronutrient|"Multiple micronutrient~Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
10961372|NCT00860535|BG000|Baseline|Ph+ CML or Ph+ ALL|Growth Factor Signature (GFS) biomarker evaluation in participants with blast phase Ph+ CML or Ph+ ALL who were treated with imatinib, dasatinib or nilotinib as per standard of care.
10961373|NCT00860535|FG000|Participant Flow|Ph+ CML or Ph+ ALL|Participants with blast phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL) who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
10961374|NCT00860535|OG000|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
10961375|NCT00860535|EG000|Reported Event|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care.
11179881|NCT02058589|EG000|Reported Event|GSK1437173A Group|Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
11179882|NCT02058589|EG001|Reported Event|Placebo Group|Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
10961376|NCT00860574|BG000|Baseline|Treatment (Allogeneic Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11.~treosulfan: Given IV~fludarabine phosphate: Given IV~total-body irradiation: Low dose starting at 2Gy~peripheral blood stem cell transplantation: Given IV per institutional standard practice~tacrolimus: Given IV or PO~allogeneic bone marrow transplantation: Given IV per institutional standard practice~allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice~methotrexate: Given IV"
11179883|NCT02058628|BG000|Baseline|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
11179884|NCT02058628|BG001|Baseline|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
11179885|NCT02058628|BG002|Baseline|Total|Total of all reporting groups
11179886|NCT02058628|FG000|Participant Flow|DUAC®|Participants received DUAC® (1.2 percent clindamycin + 3 percent of benzoyl peroxide [BPO]) once daily in the evening for 12 weeks as per the randomization schedule.
10961377|NCT00860574|FG000|Participant Flow|Treatment (Allogeneic Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.~treosulfan: Given IV~fludarabine phosphate: Given IV~total-body irradiation: Low dose starting at 2Gy~peripheral blood stem cell transplantation: Given IV per institutional standard practice~tacrolimus: Given IV or PO~allogeneic bone marrow transplantation: Given IV per institutional standard practice~allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice~methotrexate: Given IV"
10961378|NCT00860574|OG000|Outcome|Treatment (Allogeneic Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.~treosulfan: Given IV~fludarabine phosphate: Given IV~total-body irradiation: Low dose starting at 2Gy~peripheral blood stem cell transplantation: Given IV per institutional standard practice~tacrolimus: Given IV or PO~allogeneic bone marrow transplantation: Given IV per institutional standard practice~allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice~methotrexate: Given IV"
10961379|NCT00860574|EG000|Reported Event|Treatment (Allogeneic Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11.~treosulfan: Given IV~fludarabine phosphate: Given IV~total-body irradiation: Low dose starting at 2Gy~peripheral blood stem cell transplantation: Given IV per institutional standard practice~tacrolimus: Given IV or PO~allogeneic bone marrow transplantation: Given IV per institutional standard practice~allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice~methotrexate: Given IV"
10961380|NCT00860743|BG000|Baseline|Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA males. These males will be matched with 10 females with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
10961381|NCT00860743|BG001|Baseline|Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA females. These females will be matched with 10 males with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
10961382|NCT00860743|BG002|Baseline|Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 healthy males. These males will be matched with 10 OSA males and 10 OSA females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
10961383|NCT00860743|BG003|Baseline|Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
10961384|NCT00860743|BG004|Baseline|Aim 2 - OSA - Hypoxia - Antioxidant/Placebo|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
10961385|NCT00860743|BG005|Baseline|Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo|We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
10961386|NCT00860743|BG006|Baseline|Total|Total of all reporting groups
10961387|NCT00860743|FG000|Participant Flow|OSA/Healthy - Males/Females - Wake/Sleep|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
10961388|NCT00860743|FG001|Participant Flow|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
11179887|NCT02058628|FG001|Participant Flow|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule.
10961389|NCT00860743|OG000|Outcome|OSA/HEALTHY - MALES/FEMALES - WAKE/SLEEP|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
10961390|NCT00860743|OG000|Outcome|OSA/HEALTHY - HYPOXIA - ANTIOXIDANT/PLACEBO|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
10961391|NCT00860743|EG000|Reported Event|Arm 1|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
10961392|NCT00860743|EG001|Reported Event|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
10961393|NCT00860795|BG000|Baseline|Echinacea|25 ml daily in 2 divided doses for 10 days
10961394|NCT00860795|BG001|Baseline|Placebo|25 ml daily in 2 divided doses for 10 days
10961395|NCT00860795|BG002|Baseline|Total|Total of all reporting groups
10961396|NCT00860795|FG000|Participant Flow|Echinacea|25 ml daily in 2 divided doses for 10 days
10961397|NCT00860795|FG001|Participant Flow|Placebo|25 ml daily in 2 divided doses for 10 days
10961398|NCT00860795|OG000|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
11234484|NCT02435680|OG001|Outcome|Carboplatin+Gemcitabine|comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 & 8 Carboplatin: Intravenous infusion AUC 2 Days 1 & 8
10961399|NCT00860795|OG001|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
10961400|NCT00860795|EG000|Reported Event|Echinacea|25 ml daily in 2 divided doses for 10 days
10961401|NCT00860795|EG001|Reported Event|Placebo|25 ml daily in 2 divided doses for 10 days
10961402|NCT00860847|BG000|Baseline|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
11234485|NCT02435680|OG000|Outcome|MCS110+Carboplatin+Gemcitabine|experimental. MCS110 10mg/kg intravenous infusion on day 1.
11234486|NCT02435680|OG001|Outcome|MCS110 With C1D8 Dose + Carboplatin +Gemcitabine|experimental.MCS110 10mg/kg intravenous infusion on days 1 & 8
10961403|NCT00860847|BG001|Baseline|Placebo|Patients randomized to placebo
11234487|NCT02435680|OG002|Outcome|Carboplatin+Gemcitabine|comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 & 8 Carboplatin: Intravenous infusion AUC 2 Days 1 & 8
10961404|NCT00860847|BG002|Baseline|Total|Total of all reporting groups
10961405|NCT00860847|FG000|Participant Flow|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
10961406|NCT00860847|FG001|Participant Flow|Placebo|Patients randomized to placebo
10961407|NCT00860847|OG000|Outcome|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
10961408|NCT00860847|OG001|Outcome|Placebo|Patients randomized to placebo
10961409|NCT00860847|EG000|Reported Event|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
10961410|NCT00860847|EG001|Reported Event|Placebo|Patients randomized to placebo
10961411|NCT00860938|BG000|Baseline|Budesonide|
10961412|NCT00860938|BG001|Baseline|Placebo|
10961413|NCT00860938|BG002|Baseline|Total|Total of all reporting groups
10961414|NCT00860938|FG000|Participant Flow|Budesonide|
10961415|NCT00860938|FG001|Participant Flow|Placebo|
10961416|NCT00860938|OG000|Outcome|Budesonide|
10961417|NCT00860938|OG001|Outcome|Placebo|
10961418|NCT00860938|EG000|Reported Event|Budesonide|
10961419|NCT00860938|EG001|Reported Event|Placebo|
10961420|NCT00860951|BG000|Baseline|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
10961421|NCT00860951|FG000|Participant Flow|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
10961422|NCT00860951|OG000|Outcome|BCI Environment|Average accuracy of selections for three sessions of text copying within the BCI as a stand-alone device.
10961423|NCT00860951|OG001|Outcome|Computer Environment|Average accuracy of selections for three sessions of text copying within the BCI acting as a keyboard replacement for a laptop computer.
10961424|NCT00860951|OG002|Outcome|Assistive Technology Enironment|Average accuracy of selections for three sessions of text copying with the BCI acting as a keyboard replacement for a communication system.
11234488|NCT02435680|EG000|Reported Event|MCS110 + Carbo/Gem|MCS110 + Carbo/Gem
11234489|NCT02435680|EG001|Reported Event|MCS110 With C1D8@Dose + Carbo/Gem|MCS110 with C1D8@dose + Carbo/Gem
11234490|NCT02435680|EG002|Reported Event|All MCS110 + @Carbo/Gem Patients|All MCS110 + @Carbo/Gem Patients
11234491|NCT02435680|EG003|Reported Event|Carbo/Gem|Carbo/Gem
11234492|NCT02435680|EG004|Reported Event|All@Patients|All@Patients
11179888|NCT02058628|OG000|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
11179889|NCT02058628|OG001|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
11179890|NCT02058628|OG000|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of benzoyl peroxide (BPO)) once daily in the evening for 12 weeks as per the randomization schedule
11179891|NCT02058628|OG001|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
11179892|NCT02058628|OG001|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization.
11179893|NCT02058628|EG000|Reported Event|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of benzoyl peroxide (BPO)) once daily in the evening for 12 weeks as per the randomization schedule
11179894|NCT02058628|EG001|Reported Event|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
11179895|NCT02058836|BG000|Baseline|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
11179896|NCT02058836|BG001|Baseline|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
11179897|NCT02058836|BG002|Baseline|Total|Total of all reporting groups
11179898|NCT02058836|FG000|Participant Flow|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
11179899|NCT02058836|FG001|Participant Flow|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
11179900|NCT02058836|OG000|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
11179901|NCT02058836|OG001|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
11179902|NCT02058836|EG000|Reported Event|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
11179903|NCT02058836|EG001|Reported Event|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
11179904|NCT02058849|BG000|Baseline|Beetroot|"Beetroot 10 grams concentrated organic beetroot crystals~Beetroot: 10g Beetroot powder mixed with 4-8 oz."
11179905|NCT02058849|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo"
11179906|NCT02058849|BG002|Baseline|Total|Total of all reporting groups
11179907|NCT02058849|FG000|Participant Flow|Beetroot|"Beetroot 10 grams concentrated organic beetroot crystals~Beetroot: 10g Beetroot powder mixed with 4-8 oz."
11179908|NCT02058849|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
11179909|NCT02058849|OG000|Outcome|Beetroot|"Beetroot 10 grams concentrated organic beetroot crystals~Beetroot: 10g Beetroot powder mixed with 4-8 oz."
11179910|NCT02058849|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo"
11179911|NCT02058849|EG000|Reported Event|Beetroot|"Beetroot 10 grams concentrated organic beetroot crystals~Beetroot: 10g Beetroot powder mixed with 4-8 oz."
10961425|NCT00860951|EG000|Reported Event|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
10961426|NCT00861146|BG000|Baseline|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
10961427|NCT00861146|BG001|Baseline|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
11179912|NCT02058849|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11179913|NCT02058940|BG000|Baseline|Exenatide|Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
11179914|NCT02058940|FG000|Participant Flow|Exenatide|Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
11179915|NCT02058940|OG000|Outcome|Exenatide|Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
11179916|NCT02058940|EG000|Reported Event|Exenatide|Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
11179917|NCT02058966|BG000|Baseline|All Participants|"Participants who completed all four study arms including:~Placebo followed by Placebo~Placebo followed by Methamphetamine (20 mg)~Entacapone (200 mg) followed by Placebo~Entacapone (200 mg) followed by Methamphetamine (20 mg)"
11179918|NCT02058966|FG000|Participant Flow|All Subjects|"Subjects will get either entacapone or placebo, then one hour later, either methamphetamine or placebo.~Placebo: capsules compounded to be of similar appearance to the active drugs~Entacapone: Entacapone 200 mg oral dose~Methamphetamine: Methamphetamine 20 mg oral dose~The research pharmacy will assign randomization; they have no contact with the subjects or clinical staff involved in direct subject care so this medication combination could occur at any of the 4 randomization visits."
11179919|NCT02058966|OG000|Outcome|Baseline|Baseline measurements were taking for each subject before drug intervention during each of the 4 visits then averaged over the 4 visits. Baseline measurements reported here are averaged across all subjects.
11179920|NCT02058966|OG001|Outcome|Placebo Followed by Placebo|"Subjects will receive placebo, then one hour later, placebo~Placebo: capsules compounded to be of similar appearance to the active drugs"
11179921|NCT02058966|OG002|Outcome|Placebo Followed by Methamphetamine|"Subjects will receive placebo, then one hour later, methamphetamine~Methamphetamine: Methamphetamine 20 mg oral dose~Placebo: capsules compounded to be of similar appearance to the active drugs"
11179922|NCT02058966|OG003|Outcome|Entacapone Followed by Placebo|"Subjects will receive entacapone, then one hour later, placebo~Entacapone: Entacapone 200 mg oral dose~Placebo: capsules compounded to be of similar appearance to the active drugs"
10961428|NCT00861146|BG002|Baseline|Total|Total of all reporting groups
10961429|NCT00861146|FG000|Participant Flow|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
10961430|NCT00861146|FG001|Participant Flow|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
10961431|NCT00861146|OG000|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
11179923|NCT02058966|OG004|Outcome|Entacapone Followed by Methamphetamine|"Subjects will receive entacapone, then one hour later, methamphetamine~Entacapone: Entacapone 200 mg oral dose~Methamphetamine: Methamphetamine 20 mg oral dose"
11179924|NCT02058966|EG000|Reported Event|Open-label Methamphetamine|Subject will receive one dose of open-label methamphetamine 20 mg oral dose on their second visit, the familiarization visit.
11179925|NCT02058966|EG001|Reported Event|Placebo-Placebo|"Subjects will receive placebo, then one hour later, placebo~Placebo: capsules compounded to be of similar appearance to the active drugs"
11179926|NCT02058966|EG002|Reported Event|Placebo-Meth|"Subjects will receive placebo, then one hour later, methamphetamine~Placebo: capsules compounded to be of similar appearance to the active drugs~Methamphetamine: Methamphetamine 20 mg oral dose"
11179927|NCT02058966|EG003|Reported Event|Entacapone-Placebo|"Subjects will receive entacapone, then one hour later, placebo~Placebo: capsules compounded to be of similar appearance to the active drugs~Entacapone: Entacapone 200 mg oral dose"
11179928|NCT02058966|EG004|Reported Event|Entacapone-Meth|"Subjects will receive entacapone, then one hour later, methamphetamine~Methamphetamine: Methamphetamine 20 mg oral dose~Entacapone: Entacapone 200 mg oral dose"
11179929|NCT02058992|BG000|Baseline|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
11179930|NCT02058992|FG000|Participant Flow|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
11179931|NCT02058992|OG000|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
11179932|NCT02058992|EG000|Reported Event|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
11179933|NCT02059005|BG000|Baseline|Specialized Community Disease Management|Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.
10961432|NCT00861146|OG001|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
10961433|NCT00861146|EG000|Reported Event|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
10961434|NCT00861146|EG001|Reported Event|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
10961435|NCT00861198|BG000|Baseline|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
10961436|NCT00861198|FG000|Participant Flow|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
10961437|NCT00861198|OG000|Outcome|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
11179934|NCT02059005|BG001|Baseline|Treatment As Usual|Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.
10961438|NCT00861198|EG000|Reported Event|ERCP|"Patients who have a medical indication for ERCP with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for the study.~ERCP as per medical indication: ERCP as per medical indication"
10961439|NCT00861263|BG000|Baseline|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
10961440|NCT00861263|FG000|Participant Flow|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
10961441|NCT00861263|OG000|Outcome|Spiral Enteroscopy Subjects|All subjects followed up after spiral enteroscopy
10961442|NCT00861263|EG000|Reported Event|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
10961443|NCT00861341|BG000|Baseline|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
10961444|NCT00861341|FG000|Participant Flow|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
10961445|NCT00861341|OG000|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
10961446|NCT00861341|EG000|Reported Event|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
10961447|NCT00861380|BG000|Baseline|10Pn3+1-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961448|NCT00861380|BG001|Baseline|10Pn2+1-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10963884|NCT00874770|OG002|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11179935|NCT02059005|BG002|Baseline|Total|Total of all reporting groups
11179936|NCT02059005|FG000|Participant Flow|Specialized Community Disease Management|Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.
11179937|NCT02059005|FG001|Participant Flow|Treatment As Usual|Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.
11179938|NCT02059005|OG000|Outcome|Treatment As Usual|Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.
11179939|NCT02059005|OG001|Outcome|Specialized Community Disease Management|Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.
11179940|NCT02059005|OG000|Outcome|Specialized Community Disease Management|Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.
11179941|NCT02059005|OG001|Outcome|Treatment As Usual|Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.
11179942|NCT02059005|EG000|Reported Event|Specialized Community Disease Management|Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.
11179943|NCT02059005|EG001|Reported Event|Treatment As Usual|Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.
11179944|NCT02059057|BG000|Baseline|LVRC System|"The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
11179945|NCT02059057|FG000|Participant Flow|LVRC System|"The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
11179946|NCT02059057|OG000|Outcome|LVRC System|"The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
11179947|NCT02059057|OG000|Outcome|LVRC System|LVRC System
11179948|NCT02059057|EG000|Reported Event|LVRC System|"The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
11179949|NCT02059070|BG000|Baseline|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
11179950|NCT02059070|BG001|Baseline|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
11179951|NCT02059070|BG002|Baseline|Total|Total of all reporting groups
11179952|NCT02059070|FG000|Participant Flow|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
11179953|NCT02059070|FG001|Participant Flow|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
11179954|NCT02059070|OG000|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
11179955|NCT02059070|OG001|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
11179956|NCT02059070|EG000|Reported Event|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
11179957|NCT02059070|EG001|Reported Event|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
11234493|NCT02435706|BG000|Baseline|Flapless Group|"Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown~Flapless immediate implant placement: No elevation of flap prior to immediate implant placement~Implant and temporary crown: Standard intervention/procedure (non-experimental)"
11234494|NCT02435706|BG001|Baseline|Flap Group|"Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown~Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement~Implant and temporary crown: Standard intervention/procedure (non-experimental)"
11234495|NCT02435706|BG002|Baseline|Total|Total of all reporting groups
11234496|NCT02435706|FG000|Participant Flow|Flapless Group|"Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown~Flapless immediate implant placement: No elevation of flap prior to immediate implant placement~Implant and temporary crown: Standard intervention/procedure (non-experimental)~Please see attached publication"
11234497|NCT02435706|FG001|Participant Flow|Flap Group|"Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown~Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement~Implant and temporary crown: Standard intervention/procedure (non-experimental)"
11234498|NCT02435706|OG000|Outcome|Flapless Group|"Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown~Flapless immediate implant placement: No elevation of flap prior to immediate implant placement~Implant and temporary crown: Standard intervention/procedure (non-experimental)~Please see attached publication"
11234499|NCT02435706|OG001|Outcome|Flap Group|"Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown~Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement~Implant and temporary crown: Standard intervention/procedure (non-experimental)"
11234500|NCT02435706|EG000|Reported Event|Flapless Group|"Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown~Flapless immediate implant placement: No elevation of flap prior to immediate implant placement~Implant and temporary crown: Standard intervention/procedure (non-experimental)~Please see attached publication"
11234501|NCT02435706|EG001|Reported Event|Flap Group|"Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown~Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement~Implant and temporary crown: Standard intervention/procedure (non-experimental)"
11234502|NCT02435836|BG000|Baseline|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
11234503|NCT02435836|FG000|Participant Flow|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
11234504|NCT02435836|OG000|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
11234505|NCT02435836|EG000|Reported Event|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
11234506|NCT02435901|BG000|Baseline|Reduced Intensity Regimen|"Administration of reduced doses of alemtuzumab (Campath-IH) IV 3mg test dose on Day -20 followed by daily dose of 10mg/dose on Day -19 to Day -17 for patients <10yrs or a daily dose of 15mg/dose on Day -19 to Day -17 for patients > 10yrs. Fludarabine 35mg/m2 daily for 4 days on Day -7 to Day -4. Melphalan 70mg/m2 daily for 2 days on Day -3 and Day -2. On Day -1 Cyclosporine OR Tacrolimus will be initiated along with Mycophenolate Mofetil as a graft vs host disease prophylaxis. On Day 0 the Human Leukocyte Antigen (HLA) matched or mismatched Hematopoietic Stem Cells from either the related or unrelated donor will be infused.~alemtuzumab (Campath IH): Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17~Fludarabine: Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.~Melphalan: Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.~Cyclosporine: Immunosuppressant to prevent graft vs host disease is given on Day -1"
11234507|NCT02435901|FG000|Participant Flow|Reduced Intensity Regimen|"Administration of reduced doses of alemtuzumab (Campath-IH) IV 3mg test dose on Day -20 followed by daily dose of 10mg/dose on Day -19 to Day -17 for patients <10yrs or a daily dose of 15mg/dose on Day -19 to Day -17 for patients > 10yrs. Fludarabine 35mg/m2 daily for 4 days on Day -7 to Day -4. Melphalan 70mg/m2 daily for 2 days on Day -3 and Day -2. On Day -1 Cyclosporine OR Tacrolimus will be initiated along with Mycophenolate Mofetil as a graft vs host disease prophylaxis. On Day 0 the Human Leukocyte Antigen (HLA) matched or mismatched Hematopoietic Stem Cells from either the related or unrelated donor will be infused~alemtuzumab (Campath IH): Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17~Fludarabine: Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.~Melphalan: Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.~Cyclosporine: Immunosuppressant to prevent graft vs host disease is given on Day -1 prior to s"
11341788|NCT03688542|FG000|Participant Flow|Intervention|"Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy.~Quality Circle Deprescribing Module: The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus.."
10963885|NCT00874770|OG003|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10961449|NCT00861380|BG002|Baseline|Ctrl-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961450|NCT00861380|BG003|Baseline|10Pn7-11M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961451|NCT00861380|BG004|Baseline|Ctrl7-11M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961452|NCT00861380|BG005|Baseline|10Pn12-18M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961453|NCT00861380|BG006|Baseline|Ctrl12-18M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961454|NCT00861380|BG007|Baseline|Total|Total of all reporting groups
10961455|NCT00861380|FG000|Participant Flow|10Pn3+1-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961456|NCT00861380|FG001|Participant Flow|10Pn2+1-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961457|NCT00861380|FG002|Participant Flow|Ctrl-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961458|NCT00861380|FG003|Participant Flow|10Pn7-11M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961459|NCT00861380|FG004|Participant Flow|Ctrl7-11M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961460|NCT00861380|FG005|Participant Flow|10Pn12-18M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
11341789|NCT03688542|FG001|Participant Flow|Control|Nursing Homes allocated to the Control arm will not enact the intervention.
10961461|NCT00861380|FG006|Participant Flow|Ctrl12-18M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961462|NCT00861380|OG000|Outcome|10Pn3+1-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
10961463|NCT00861380|OG001|Outcome|Ctrl-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
10961464|NCT00861380|OG000|Outcome|10Pn2+1-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 942 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
10961465|NCT00861380|OG000|Outcome|10Pn7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
10963886|NCT00874770|OG000|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Rribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11234508|NCT02435901|OG000|Outcome|Reduced Intensity Regimen|"Alemtuzumab (Campath-IH) IV 3mg test dose on Day -20 followed by 10mg/dose on Day -19 to Day -17 for patients <10yrs or a daily dose of 15mg/dose on Day -19 to Day -17 for patients > 10yrs. Fludarabine 35mg/m2 daily for 4 days on Day -7 to Day -4. Melphalan 70mg/m2 daily for 2 days on Day -3 and Day -2. Day -1 Cyclosporine OR Tacrolimus along with Mycophenolate Mofetil as a graft vs host disease prophylaxis. On Day 0 the HLA matched or mismatched Hematopoietic Stem Cells from either the related or unrelated donor will be infused.~alemtuzumab (Campath IH): Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17~Fludarabine: Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.~Melphalan: Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.~Cyclosporine: Immunosuppressant to prevent graft vs host disease is given on Day -1 prior to s"
11234509|NCT02435901|OG000|Outcome|Reduced Intensity Regimen|"Alemtuzumab (Campath-IH) IV 3mg test dose on Day -20 followed by daily dose of 10mg/dose on Day -19 to Day -17 for patients <10yrs or a daily dose of 15mg/dose on Day -19 to Day -17 for patients > 10yrs. Fludarabine 35mg/m2 daily for 4 days on Day -7 to Day -4. Melphalan 70mg/m2 daily for 2 days on Day -3 and Day -2. Day -1 Cyclosporine OR Tacrolimus along with Mycophenolate Mofetil as a graft vs host disease prophylaxis. On Day 0 the HLA matched or mismatched Hematopoietic Stem Cells from either the related or unrelated donor will be infused.~alemtuzumab (Campath IH): Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17~Fludarabine: Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.~Melphalan: Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.~Cyclosporine: Immunosuppressant to prevent graft vs host disease is given on Day -1 prior to s"
11234510|NCT02435901|EG000|Reported Event|Reduced Intensity Regimen|"Alemtuzumab (Campath-IH) IV 3mg test dose on Day -20 followed by daily dose of 10mg/dose on Day -19 to Day -17 for patients <10yrs or a daily dose of 15mg/dose on Day -19 to Day -17 for patients > 10yrs. Fludarabine 35mg/m2 daily for 4 days on Day -7 to Day -4. Melphalan 70mg/m2 daily for 2 days on Day -3 and Day -2. Day -1 Cyclosporine OR Tacrolimus along with Mycophenolate Mofetil as a graft vs host disease prophylaxis. Day 0 the HLA matched or mismatched Hematopoietic Stem Cells from either the related or unrelated donor will be infused.~alemtuzumab (Campath IH): Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17~Fludarabine: Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.~Melphalan: Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.~Cyclosporine: Immunosuppressant to prevent graft vs host disease is given on Day -1~Mycophenolate mofetil: Immunosuppressant to prevent graft vs host"
11234511|NCT02435914|BG000|Baseline|AGN-223575 Dose A|1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
10961466|NCT00861380|OG001|Outcome|Ctrl7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
10961467|NCT00861380|OG000|Outcome|10Pn12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
10961468|NCT00861380|OG001|Outcome|Ctrl12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
10961469|NCT00861380|OG001|Outcome|10Pn2+1-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 942 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
10961470|NCT00861380|OG002|Outcome|Ctrl-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
10961471|NCT00861380|OG001|Outcome|10Pn2+1-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 942 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
10961472|NCT00861380|OG002|Outcome|Ctrl-6W-6M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
10961473|NCT00861380|OG003|Outcome|10Pn7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
10961474|NCT00861380|OG004|Outcome|Ctrl7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
10961475|NCT00861380|OG005|Outcome|10Pn12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
10961476|NCT00861380|OG006|Outcome|Ctrl12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
10961477|NCT00861380|OG000|Outcome|10Pn3+1-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961478|NCT00861380|OG001|Outcome|10Pn2+1-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961479|NCT00861380|OG002|Outcome|Ctrl-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961480|NCT00861380|OG003|Outcome|10Pn7-11M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961481|NCT00861380|OG004|Outcome|Ctrl7-11M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961482|NCT00861380|OG005|Outcome|10Pn12-18M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961483|NCT00861380|OG006|Outcome|Ctrl12-18M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961484|NCT00861380|OG004|Outcome|Ctrl7-11M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
10961485|NCT00861380|OG005|Outcome|10Pn12-18M/043+053 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
10961486|NCT00861380|EG000|Reported Event|10Pn3+1-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961487|NCT00861380|EG001|Reported Event|10Pn2+1-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
11234512|NCT02435914|BG001|Baseline|AGN-223575 Dose B|1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
11234513|NCT02435914|BG002|Baseline|AGN-223575 Dose C|1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
11234514|NCT02435914|BG003|Baseline|AGN-223575 Vehicle|1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
11234515|NCT02435914|BG004|Baseline|Total|Total of all reporting groups
11234516|NCT02435914|FG000|Participant Flow|AGN-223575 Dose A|1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
10847219|NCT00282295|EG000|Reported Event|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
10847220|NCT00282295|EG001|Reported Event|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847221|NCT00282295|EG002|Reported Event|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
10847222|NCT00282308|BG000|Baseline|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
10847223|NCT00282308|BG001|Baseline|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
10847224|NCT00282308|BG002|Baseline|Total|Total of all reporting groups
10847225|NCT00282308|FG000|Participant Flow|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
10847226|NCT00282308|FG001|Participant Flow|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
10847227|NCT00282308|FG002|Participant Flow|All Patients (Combined Groups A and B)|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
10847228|NCT00282308|OG000|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
10847229|NCT00282308|OG001|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
10847230|NCT00282308|EG000|Reported Event|Rituximab + Methotrexate (Group A) - Treatment Period|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
10847231|NCT00282308|EG001|Reported Event|Methotrexate (Group B) - Treatment Period|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
10847232|NCT00282308|EG002|Reported Event|Group A - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
10847233|NCT00282308|EG003|Reported Event|Group B - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
10847234|NCT00282308|EG004|Reported Event|Group A - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
10847235|NCT00282308|EG005|Reported Event|Group B - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
10847236|NCT00282334|BG000|Baseline|Conventional Blood Pressure Monitoring|
10847237|NCT00282334|BG001|Baseline|Telemonitoring of Home Blood Press|
10847238|NCT00282334|BG002|Baseline|Total|Total of all reporting groups
10847239|NCT00282334|FG000|Participant Flow|Telemonitoring|Telemonitoring of home blood pressure
10847240|NCT00282334|FG001|Participant Flow|Conventional|Conventional blood pressure monitoring
10847241|NCT00282334|OG000|Outcome|Conventional Blood Pressure Monitoring|
10847242|NCT00282334|OG001|Outcome|Telemonitoring of Home Blood Press|
10847243|NCT00282334|EG000|Reported Event|Conventional Blood Pressure Monitoring|
10847244|NCT00282334|EG001|Reported Event|Telemonitoring of Home Blood Press|
10847245|NCT00282347|BG000|Baseline|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10847246|NCT00282347|BG001|Baseline|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10847247|NCT00282347|BG002|Baseline|Total|Total of all reporting groups
10847248|NCT00282347|FG000|Participant Flow|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10961488|NCT00861380|EG002|Reported Event|Ctrl-6W-6M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
10961489|NCT00861380|EG003|Reported Event|10Pn7-11M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961490|NCT00861380|EG004|Reported Event|Ctrl7-11M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961491|NCT00861380|EG005|Reported Event|10Pn12-18M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961492|NCT00861380|EG006|Reported Event|Ctrl12-18M/043 Group|Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
10961493|NCT00861471|BG000|Baseline|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
10961494|NCT00861471|FG000|Participant Flow|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
11234517|NCT02435914|FG001|Participant Flow|AGN-223575 Dose B|1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
11234518|NCT02435914|FG002|Participant Flow|AGN-223575 Dose C|1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
11234519|NCT02435914|FG003|Participant Flow|AGN-223575 Vehicle|1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
11234520|NCT02435914|OG000|Outcome|AGN-223575 Dose A|1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
11234521|NCT02435914|OG001|Outcome|AGN-223575 Dose B|1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
10961495|NCT00861471|OG000|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
10961496|NCT00861471|EG000|Reported Event|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
10961497|NCT00861601|BG000|Baseline|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
10961498|NCT00861601|BG001|Baseline|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
11234522|NCT02435914|OG002|Outcome|AGN-223575 Dose C|1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
11234523|NCT02435914|OG003|Outcome|AGN-223575 Vehicle|1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
11234524|NCT02435914|EG000|Reported Event|AGN-223575 Dose A|1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
11234525|NCT02435914|EG001|Reported Event|AGN-223575 Dose B|1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
10961499|NCT00861601|BG002|Baseline|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
10961500|NCT00861601|BG003|Baseline|Total|Total of all reporting groups
10961501|NCT00861601|FG000|Participant Flow|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
10961502|NCT00861601|FG001|Participant Flow|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
10961503|NCT00861601|FG002|Participant Flow|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
10961504|NCT00861601|OG000|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
10961505|NCT00861601|OG001|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
11179958|NCT02059135|BG000|Baseline|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days~Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
11179959|NCT02059135|BG001|Baseline|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.~Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
11179960|NCT02059135|BG002|Baseline|Total|Total of all reporting groups
11179961|NCT02059135|FG000|Participant Flow|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days~Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
11179962|NCT02059135|FG001|Participant Flow|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.~Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
10961506|NCT00861601|OG002|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
11179963|NCT02059135|OG000|Outcome|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days~Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
11179964|NCT02059135|OG001|Outcome|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.~Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
11179965|NCT02059135|EG000|Reported Event|Maternal/Fetal Safety Population: ATryn|"Subjects treated with Recombinant human antithrombin (ATryn):~ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
11179966|NCT02059135|EG001|Reported Event|Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%)|Subjects treated with Placebo; Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.
10961507|NCT00861601|OG000|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
10961508|NCT00861601|OG001|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
10961509|NCT00861601|OG002|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
10961510|NCT00861601|EG000|Reported Event|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
10961511|NCT00861601|EG001|Reported Event|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
10961512|NCT00861601|EG002|Reported Event|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
11179967|NCT02059135|EG002|Reported Event|Neonatal Safety Population: ATryn|Neonates born to mothers treated with Recombinant Human Antithrombin (ATryn)
11179968|NCT02059135|EG003|Reported Event|Neonatal Safety Population: Placebo|Neonates born to mothers treated with placebo (Normal Saline 0.9%)
11179969|NCT02059148|BG000|Baseline|All Study Participants|Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal. Dosing occasions were separated by at least 14 days.
11179970|NCT02059148|FG000|Participant Flow|Sequence 1|Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal. Dosing occasions were separated by at least 14 days.
11179971|NCT02059148|FG001|Participant Flow|Sequence 2|Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, High-Fat Meal, Fasted State. Dosing occasions were separated by at least 14 days.
11179972|NCT02059148|FG002|Participant Flow|Sequence 3|Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Fasted State, High-Fat Meal, Standard Meal. Dosing occasions were separated by at least 14 days.
11179973|NCT02059148|FG003|Participant Flow|Sequence 4|Single oral dose of 200 mg LY2835219 on 3 Occasions: Fasted State, Standard Meal, High-Fat Meal. Dosing occasions were separated by at least 14 days.
10961513|NCT00861614|BG000|Baseline|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4,7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
10961514|NCT00861614|BG001|Baseline|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed PD, drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
10961515|NCT00861614|BG002|Baseline|Total|Total of all reporting groups
11179974|NCT02059148|FG004|Participant Flow|Sequence 5|Single oral dose of 200 mg LY2835219 on 3 Occasions: High-Fat Meal, Fasted State, Standard Meal. Dosing occasions were separated by at least 14 days.
11179975|NCT02059148|FG005|Participant Flow|Sequence 6|Single Oral Dose of 200 mg LY2835219 on 3 Occasions: High-Fat Meal, Standard Meal, Fasted State. Dosing occasions were separated by at least 14 days.
11179976|NCT02059148|OG000|Outcome|LY2835219 Fasted|"Single oral dose of LY2835219 given with no food in one of three periods.~LY2835219: Administered orally."
11179977|NCT02059148|OG001|Outcome|LY2835219 High-Fat|"Single oral dose of LY2835219 given with a high fat meal in one of three periods.~LY2835219: Administered orally."
11179978|NCT02059148|OG000|Outcome|LY2835219 Standard|"Single oral dose of LY2835219 given with a standard meal in one of three study periods.~LY2835219 administered orally."
11179979|NCT02059148|OG000|Outcome|LY2835219 Standard|"Single oral dose of LY2835219 given with a standard meal in one of three study periods.~LY2835219: Administered orally."
11179980|NCT02059148|OG001|Outcome|LY2835219 Fasted|"Single oral dose of LY2835219 given with no food in one of three periods.~LY2835219: Administered orally."
11179981|NCT02059148|OG002|Outcome|LY2835219 High-Fat|"Single oral dose of LY2835219 given with a high fat meal in one of three periods.~LY2835219: Administered orally."
11179982|NCT02059148|EG000|Reported Event|LY2835219 Standard|"Single oral dose of LY2835219 given with a standard meal in one of three study periods.~LY2835219: Administered orally."
11179983|NCT02059148|EG001|Reported Event|LY2835219 Fasted|"Single oral dose of LY2835219 given with no food in one of three periods.~LY2835219: Administered orally."
11179984|NCT02059148|EG002|Reported Event|LY2835219 High-Fat|"Single oral dose of LY2835219 given with a high fat meal in one of three periods.~LY2835219: Administered orally."
11179985|NCT02059161|BG000|Baseline|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
11179986|NCT02059161|BG001|Baseline|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
10961516|NCT00861614|FG000|Participant Flow|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gray units (Gy) to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
10963887|NCT00874770|OG002|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11179987|NCT02059161|BG002|Baseline|Total|Total of all reporting groups
11179988|NCT02059161|FG000|Participant Flow|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
11179989|NCT02059161|FG001|Participant Flow|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
11179990|NCT02059161|OG000|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
11179991|NCT02059161|OG001|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
10961517|NCT00861614|FG001|Participant Flow|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
10961518|NCT00861614|OG000|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
10961519|NCT00861614|OG001|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
10961520|NCT00861614|EG000|Reported Event|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
10961521|NCT00861614|EG001|Reported Event|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
10961522|NCT00861692|BG000|Baseline|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
10961523|NCT00861692|FG000|Participant Flow|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
10961524|NCT00861692|OG000|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
10961525|NCT00861692|EG000|Reported Event|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
10961526|NCT00861744|BG000|Baseline|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961527|NCT00861744|BG001|Baseline|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961528|NCT00861744|BG002|Baseline|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961529|NCT00861744|BG003|Baseline|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961530|NCT00861744|BG004|Baseline|Total|Total of all reporting groups
10963888|NCT00874770|OG001|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10-mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10961531|NCT00861744|FG000|Participant Flow|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961532|NCT00861744|FG001|Participant Flow|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961533|NCT00861744|FG002|Participant Flow|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961534|NCT00861744|FG003|Participant Flow|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
11179992|NCT02059161|EG000|Reported Event|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
11179993|NCT02059161|EG001|Reported Event|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
11179994|NCT02059174|BG000|Baseline|All Participants|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
11179995|NCT02059174|FG000|Participant Flow|MK-1293 / EU-Lantus™ / MK-1293 / EU-Lantus™|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
10961535|NCT00861744|OG000|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
11179996|NCT02059174|FG001|Participant Flow|EU-Lantus™ / MK-1293 / EU-Lantus™ / MK-1293|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
11179997|NCT02059174|OG000|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
11179998|NCT02059174|OG001|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
11179999|NCT02059174|EG000|Reported Event|MK-1293 0.4 Units/kg SC|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between treatment periods
11180000|NCT02059174|EG001|Reported Event|EU-Lantus™ 0.4 Units.kg SC|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between treatment periods
11180001|NCT02059187|BG000|Baseline|MK-1293|MK-1293 administered subcutaneously once daily.
11180002|NCT02059187|BG001|Baseline|Lantus™|Lantus™ administered subcutaneously once daily.
11180003|NCT02059187|BG002|Baseline|Total|Total of all reporting groups
11180004|NCT02059187|FG000|Participant Flow|MK-1293|MK-1293 administered subcutaneously once daily.
11180005|NCT02059187|FG001|Participant Flow|Lantus™|Lantus™ administered subcutaneously once daily.
11180006|NCT02059187|OG000|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
11180007|NCT02059187|OG001|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
11180008|NCT02059187|EG000|Reported Event|MK-1293|MK-1293 administered subcutaneously once daily.
11180009|NCT02059187|EG001|Reported Event|Lantus™|Lantus™ administered subcutaneously once daily.
11180010|NCT02059213|BG000|Baseline|ADT Alone|Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180011|NCT02059213|BG001|Baseline|ADT + Ibrance®|Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180012|NCT02059213|BG002|Baseline|Total|Total of all reporting groups
10961536|NCT00861744|OG001|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961537|NCT00861744|OG002|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961538|NCT00861744|OG003|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961539|NCT00861744|EG000|Reported Event|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961540|NCT00861744|EG001|Reported Event|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961541|NCT00861744|EG002|Reported Event|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961542|NCT00861744|EG003|Reported Event|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
10961543|NCT00861757|BG000|Baseline|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
11234526|NCT02435914|EG002|Reported Event|AGN-223575 Dose C|1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
11234527|NCT02435914|EG003|Reported Event|AGN-223575 Vehicle|1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
11234528|NCT02435966|BG000|Baseline|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
10961544|NCT00861757|BG001|Baseline|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
10961545|NCT00861757|BG002|Baseline|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
10961546|NCT00861757|BG003|Baseline|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
10961547|NCT00861757|BG004|Baseline|Total|Total of all reporting groups
10961548|NCT00861757|FG000|Participant Flow|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
10961549|NCT00861757|FG001|Participant Flow|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
11234529|NCT02435966|BG001|Baseline|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
11234530|NCT02435966|BG002|Baseline|Untreated Control|Natural history of the condition
11234531|NCT02435966|BG003|Baseline|Total|Total of all reporting groups
11234532|NCT02435966|FG000|Participant Flow|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
11180013|NCT02059213|FG000|Participant Flow|ADT Alone|Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180014|NCT02059213|FG001|Participant Flow|ADT + Ibrance®|Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180015|NCT02059213|OG000|Outcome|ADT Alone|Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180016|NCT02059213|OG001|Outcome|ADT + Ibrance®|Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180017|NCT02059213|OG000|Outcome|ADT Alone|"Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).~Bicalutamide~Zoladex~Lupron Depot"
11180018|NCT02059213|OG001|Outcome|ADT + Ibrance®|"Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).~Ibrance~Bicalutamide~Zoladex~Lupron Depot"
11180019|NCT02059213|OG000|Outcome|ADT + Ibrance®|Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180020|NCT02059213|EG000|Reported Event|ADT Alone|Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180021|NCT02059213|EG001|Reported Event|ADT + Ibrance®|Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
11180022|NCT02059239|BG000|Baseline|Chemo Plus Autologous Transplantation|"Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant~Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days.~Carmustine: 300 mg/m2 on Day -6~Etoposide: 100 mg/m2 on days -5 to -2~Melphalan: 140mg/m2 on Day -1~Cytarabine: 200 mg/m2 on days -5 to -2~Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors~Autologous Stem Cell Transplantation~Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant"
11180023|NCT02059239|BG001|Baseline|Chemo Plus Allogeneic Transplantation|"Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant~Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days.~Carmustine: 300 mg/m2 on Day -6~Etoposide: 100 mg/m2 on days -5 to -2~Melphalan: 140mg/m2 on Day -1~Cytarabine: 200 mg/m2 on days -5 to -2~Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors~Allogeneic Stem Cell Transplantation~Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant"
11180024|NCT02059239|BG002|Baseline|Total|Total of all reporting groups
11180025|NCT02059239|FG000|Participant Flow|Chemo Plus Autologous Transplantation|"Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant~Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days.~Carmustine: 300 mg/m2 on Day -6~Etoposide: 100 mg/m2 on days -5 to -2~Melphalan: 140mg/m2 on Day -1~Cytarabine: 200 mg/m2 on days -5 to -2~Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors~Autologous Stem Cell Transplantation~Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant"
11180026|NCT02059239|FG001|Participant Flow|Chemo Plus Allogeneic Transplantation|"Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant~Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days.~Carmustine: 300 mg/m2 on Day -6~Etoposide: 100 mg/m2 on days -5 to -2~Melphalan: 140mg/m2 on Day -1~Cytarabine: 200 mg/m2 on days -5 to -2~Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors~Allogeneic Stem Cell Transplantation~Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant"
11180027|NCT02059239|OG000|Outcome|Chemo Plus Autologous Transplantation|"Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant~Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days.~Carmustine: 300 mg/m2 on Day -6~Etoposide: 100 mg/m2 on days -5 to -2~Melphalan: 140mg/m2 on Day -1~Cytarabine: 200 mg/m2 on days -5 to -2~Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors~Autologous Stem Cell Transplantation~Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant"
10961550|NCT00861757|FG002|Participant Flow|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
11180028|NCT02059239|OG001|Outcome|Chemo Plus Allogeneic Transplantation|"Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant~Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days.~Carmustine: 300 mg/m2 on Day -6~Etoposide: 100 mg/m2 on days -5 to -2~Melphalan: 140mg/m2 on Day -1~Cytarabine: 200 mg/m2 on days -5 to -2~Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors~Allogeneic Stem Cell Transplantation~Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant"
11180029|NCT02059239|EG000|Reported Event|Bendamustine|Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days
11180030|NCT02059239|EG001|Reported Event|Bendamustine Plus Autologous Transplantation|"Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant~Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days.~Carmustine: 300 mg/m2 on Day -6~Etoposide: 100 mg/m2 on days -5 to -2~Melphalan: 140mg/m2 on Day -1~Cytarabine: 200 mg/m2 on days -5 to -2~Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors~Autologous Stem Cell Transplantation~Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant"
11180031|NCT02059239|EG002|Reported Event|Bendamustine Plus Allogeneic Transplantation|"Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant~Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days.~Carmustine: 300 mg/m2 on Day -6~Etoposide: 100 mg/m2 on days -5 to -2~Melphalan: 140mg/m2 on Day -1~Cytarabine: 200 mg/m2 on days -5 to -2~Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors~Allogeneic Stem Cell Transplantation~Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant"
11180032|NCT02059278|BG000|Baseline|T-2345|T-2345 Ophthalmic Solution
11180033|NCT02059278|BG001|Baseline|Xalatan|Xalatan (Latanoprost 0.005% Ophthalmic Solution)
11180034|NCT02059278|BG002|Baseline|Total|Total of all reporting groups
11180035|NCT02059278|FG000|Participant Flow|T-2345|T-2345 Ophthalmic Solution
11180036|NCT02059278|FG001|Participant Flow|Xalatan|Xalatan (Latanoprost 0.005% Ophthalmic Solution)
11180037|NCT02059278|OG000|Outcome|T-2345|T-2345 Ophthalmic Solution
11180038|NCT02059278|OG001|Outcome|Xalatan|Xalatan (Latanoprost 0.005% Ophthalmic Solution)
11180039|NCT02059278|EG000|Reported Event|T-2345|T-2345 Ophthalmic Solution
11180040|NCT02059278|EG001|Reported Event|Xalatan|Xalatan (Latanoprost 0.005% Ophthalmic Solution)
11180041|NCT02059291|BG000|Baseline|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
10961551|NCT00861757|FG003|Participant Flow|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
10961552|NCT00861757|OG000|Outcome|Placebo|Drug: Placebo PO, QD (30min after meal) for 12 weeks
10961553|NCT00861757|OG001|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
11180042|NCT02059291|BG001|Baseline|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
11180043|NCT02059291|BG002|Baseline|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
11180044|NCT02059291|BG003|Baseline|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
11180045|NCT02059291|BG004|Baseline|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
10961554|NCT00861757|OG002|Outcome|5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
10961555|NCT00861757|OG003|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
10961556|NCT00861757|OG000|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
10961557|NCT00861757|OG001|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
10961558|NCT00861757|OG002|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
10961559|NCT00861757|OG003|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
10961560|NCT00861757|EG000|Reported Event|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
10961561|NCT00861757|EG001|Reported Event|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
10961562|NCT00861757|EG002|Reported Event|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
10961563|NCT00861757|EG003|Reported Event|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
10961564|NCT00861913|BG000|Baseline|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961565|NCT00861913|FG000|Participant Flow|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961566|NCT00861913|OG000|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961567|NCT00861913|EG000|Reported Event|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10961568|NCT00862082|BG000|Baseline|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961569|NCT00862082|BG001|Baseline|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961570|NCT00862082|BG002|Baseline|Total|Total of all reporting groups
10961571|NCT00862082|FG000|Participant Flow|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961572|NCT00862082|FG001|Participant Flow|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961573|NCT00862082|OG000|Outcome|Cohorts 1 and 2|770 and 550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961574|NCT00862082|OG000|Outcome|Cohort 1|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961575|NCT00862082|OG001|Outcome|Cohort 2|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961576|NCT00862082|OG000|Outcome|PR104|
10961577|NCT00862082|OG001|Outcome|PR104A|major plasma metabolite
10961578|NCT00862082|OG002|Outcome|PR104G|major plasma metabolite
10961579|NCT00862082|OG003|Outcome|PR104S1|semi-mustard metabolite
10961580|NCT00862082|OG004|Outcome|PR104H|activated reduced metabolites
10961581|NCT00862082|OG005|Outcome|PR104M|activated reduced metabolites
10961582|NCT00862082|EG000|Reported Event|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961583|NCT00862082|EG001|Reported Event|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
10961584|NCT00862121|BG000|Baseline|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
10961585|NCT00862121|BG001|Baseline|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
10961586|NCT00862121|BG002|Baseline|Total|Total of all reporting groups
10961587|NCT00862121|FG000|Participant Flow|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
10961588|NCT00862121|FG001|Participant Flow|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
10961589|NCT00862121|OG000|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
10961590|NCT00862121|OG001|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
10961591|NCT00862121|EG000|Reported Event|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
10961592|NCT00862121|EG001|Reported Event|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
10961593|NCT00862134|BG000|Baseline|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
10961594|NCT00862134|BG001|Baseline|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
10961595|NCT00862134|BG002|Baseline|Total|Total of all reporting groups
10961596|NCT00862134|FG000|Participant Flow|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
10961597|NCT00862134|FG001|Participant Flow|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic Granulocyte Colony-stimulating Factor (G-CSF).
10961598|NCT00862134|OG000|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
10961599|NCT00862134|OG001|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
10961600|NCT00862134|EG000|Reported Event|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
10961601|NCT00862134|EG001|Reported Event|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
10963889|NCT00874770|OG003|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weekswith pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10961602|NCT00862186|BG000|Baseline|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
10961603|NCT00862186|FG000|Participant Flow|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
10961604|NCT00862186|OG000|Outcome|Resource Use|Fatigue Facts & Fixes was assessed for amount of resource use on a 1-5 Likert-type scale.
10961605|NCT00862186|OG001|Outcome|Resource Helpfulness|Fatigue Facts & Fixes was assessed for amount of resource helpfulness on a 1-5 Likert-type scale.
10961606|NCT00862186|EG000|Reported Event|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
10961607|NCT00862277|BG000|Baseline|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
10961608|NCT00862277|BG001|Baseline|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
10961609|NCT00862277|BG002|Baseline|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
10961610|NCT00862277|BG003|Baseline|Total|Total of all reporting groups
10961611|NCT00862277|FG000|Participant Flow|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
10961612|NCT00862277|FG001|Participant Flow|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
10961613|NCT00862277|FG002|Participant Flow|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
10961614|NCT00862277|OG000|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
10961615|NCT00862277|OG001|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
10961616|NCT00862277|OG002|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
10961617|NCT00862277|EG000|Reported Event|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
10961618|NCT00862277|EG001|Reported Event|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
10961619|NCT00862277|EG002|Reported Event|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
10961620|NCT00862446|BG000|Baseline|Omegaven Treatment|All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
10961621|NCT00862446|FG000|Participant Flow|Omegaven Treatment|All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
10961622|NCT00862446|OG000|Outcome|Omegaven Treatment|All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
10961623|NCT00862446|EG000|Reported Event|Omegaven Treatment|All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
10961624|NCT00862459|BG000|Baseline|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
10961625|NCT00862459|BG001|Baseline|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961626|NCT00862459|BG002|Baseline|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961627|NCT00862459|BG003|Baseline|Total|Total of all reporting groups
11234533|NCT02435966|FG001|Participant Flow|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
11180046|NCT02059291|BG005|Baseline|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
11180047|NCT02059291|BG006|Baseline|Epoch 2: Non-randomized Open Label Treatment - crFMF|"Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing~≤ 40 kg) q4w"
11180048|NCT02059291|BG007|Baseline|Epoch 2: Non-randomized Open Label HIDS/MKD|"Participants in the 28 days to less than 2 years old cohort who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing~≤ 40 kg) q4w."
11180049|NCT02059291|BG008|Baseline|Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS|Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M.
11180050|NCT02059291|BG009|Baseline|Total|Total of all reporting groups
11180051|NCT02059291|FG000|Participant Flow|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
11180052|NCT02059291|FG001|Participant Flow|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
11180053|NCT02059291|FG002|Participant Flow|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
11180054|NCT02059291|FG003|Participant Flow|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
11180055|NCT02059291|FG004|Participant Flow|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
11180056|NCT02059291|FG005|Participant Flow|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
11180057|NCT02059291|FG006|Participant Flow|Epoch 2: Non-randomized Open Label Treatment - crFMF|"Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing~≤ 40 kg) q4w ."
11180058|NCT02059291|FG007|Participant Flow|Epoch 2: Non-randomized Open Label HIDS/MKD|"Participants in the 28 days to less than 2 years old cohort who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing~≤ 40 kg) q4w."
11180059|NCT02059291|FG008|Participant Flow|Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS|Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M.
11180060|NCT02059291|FG009|Participant Flow|Epoch 3: crFMF Re-randomized From Epoch 2 - 150 mg|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
11180061|NCT02059291|FG010|Participant Flow|Epoch 3: crFMF Re-randomized From Epoch 2 - Placebo|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
11180062|NCT02059291|FG011|Participant Flow|Epoch 3: HIDs/MKD Re-randomized From Epoch 2 - 150 mg|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
11180063|NCT02059291|FG012|Participant Flow|Epoch 3: HIDS/MKD Re-randomized From Epoch 2 - Placebo|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
11180064|NCT02059291|FG013|Participant Flow|Epoch 3: TRAPS Re-randomized From Epoch 2 - 150 mg|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
11180065|NCT02059291|FG014|Participant Flow|Epoch 3: TRAPS Re-randomized From Epoch 2 - Placebo|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
11180066|NCT02059291|FG015|Participant Flow|Epoch 3: crFMF, HIDS/MKD, TRAPS - Not Re-randomized|All Epoch 2 non-responders were switched to canakinumab q8w at the start of Epoch 3 for 24 weeks,
11180067|NCT02059291|FG016|Participant Flow|Epoch 4: crFMF - Open Label Cumulative Dose <2700 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
11180068|NCT02059291|FG017|Participant Flow|Epoch 4: crFMF - Open Label Cumulative Dose 2700 mg - <5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was >= 2700 mg and < 5400 mg.
11180069|NCT02059291|FG018|Participant Flow|Epoch 4: crFMF - Open Label Cumulative Dose >=5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was > 5400 mg.
11180070|NCT02059291|FG019|Participant Flow|Epoch 4: HIDS/MKD - Open Label Cumulative Dose <2700 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
11180071|NCT02059291|FG020|Participant Flow|Epoch 4: HIDS/MKD - OL Cumulative Dose 2700 - <=5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was >= 2700 mg and < 5400 mg.
11180072|NCT02059291|FG021|Participant Flow|Epoch 4: HIDS/MKD - Open Label Cumulative Dose >=5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was > 5400 mg.
11180073|NCT02059291|FG022|Participant Flow|Epoch 4: TRAPS - Open Label Cumulative Dose < 2700 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
11180074|NCT02059291|FG023|Participant Flow|Epoch 4: TRAPS - Open Label Cumulative Dose 2700 - <5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was >= 2700 mg and < 5400 mg.
11180075|NCT02059291|FG024|Participant Flow|Epoch 4: TRAPS - Open Label Cumulative Dose >=5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was > 5400 mg.
11180076|NCT02059291|OG000|Outcome|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
11180077|NCT02059291|OG001|Outcome|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
11180078|NCT02059291|OG002|Outcome|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
11180079|NCT02059291|OG003|Outcome|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
11180080|NCT02059291|OG004|Outcome|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
11180081|NCT02059291|OG005|Outcome|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
11180082|NCT02059291|EG000|Reported Event|Non-randomized Open Label crFMF, HIDS/MKD Patients|"Canakinumab-naïve Japanese patients with non-exon 10 mutations with cr-FMF who received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing ≤ 40 kg) q4w; and patients in the 28 days to less than 2 years old cohort with HIDS/MKD who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing~≤ 40 kg) q4w"
11180083|NCT02059291|EG001|Reported Event|Non-randomized Open Label TRAPS Patients|Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M
11180084|NCT02059291|EG002|Reported Event|Randomized ACZ and Placebo TRAPS Patients - Placebo Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3.
11180085|NCT02059291|EG003|Reported Event|Randomized ACZ and Placebo TRAPS Pts - No Medication Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3 .
11180086|NCT02059291|EG004|Reported Event|Randomized ACZ and Placebo TRAPS Patients - ACZ Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
10961628|NCT00862459|FG000|Participant Flow|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
11180087|NCT02059291|EG005|Reported Event|Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
11180088|NCT02059291|EG006|Reported Event|Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
11180089|NCT02059291|EG007|Reported Event|Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
11180090|NCT02059291|EG008|Reported Event|Randomized ACZ and Placebo crFMF Patients - Placebo Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
11180091|NCT02059291|EG009|Reported Event|Randomized ACZ and Placebo crFMF Pts - No Medication Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
11180092|NCT02059291|EG010|Reported Event|Randomized ACZ and Placebo crFMF Patients - ACZ Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
11180093|NCT02059291|EG011|Reported Event|Any ACZ TRAPS Patients - Placebo Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180094|NCT02059291|EG012|Reported Event|Any ACZ TRAPS Patients - no Medication Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180095|NCT02059291|EG013|Reported Event|Any ACZ TRAPS Patients - ACZ Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180096|NCT02059291|EG014|Reported Event|Any ACZ HIDS/MKD Patients - Placebo Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180097|NCT02059291|EG015|Reported Event|Any ACZ HIDS/MKD Patients - No Medication Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180098|NCT02059291|EG016|Reported Event|Any ACZ HIDS/MKD Patients - ACZ Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180099|NCT02059291|EG017|Reported Event|Any ACZ crFMF Patients - Placebo Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180100|NCT02059291|EG018|Reported Event|Any ACZ crFMF Patients - No Medication Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180101|NCT02059291|EG019|Reported Event|Any ACZ crFMF Patients - ACZ Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
11180102|NCT02059395|BG000|Baseline|Time Based|"Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course~Time based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout"
11180103|NCT02059395|BG001|Baseline|Mastery Based|"Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)~Mastery based learning: Participants are allowed to follow the course content at their own speed"
11180104|NCT02059395|BG002|Baseline|Total|Total of all reporting groups
11180105|NCT02059395|FG000|Participant Flow|Time Based|"Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course~Time based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout"
11180106|NCT02059395|FG001|Participant Flow|Mastery Based|"Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)~Mastery based learning: Participants are allowed to follow the course content at their own speed"
11180107|NCT02059395|OG000|Outcome|Time Based|"Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course~Time based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout"
11180108|NCT02059395|OG001|Outcome|Mastery Based|"Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)~Mastery based learning: Participants are allowed to follow the course content at their own speed"
11180109|NCT02059395|EG000|Reported Event|Time Based|"Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course~Time based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout"
11180110|NCT02059395|EG001|Reported Event|Mastery Based|"Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)~Mastery based learning: Participants are allowed to follow the course content at their own speed"
11180111|NCT02059408|BG000|Baseline|Usual Care|The patients in this arm will receive normal primary care.
11180112|NCT02059408|BG001|Baseline|Screen-Educate|"Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.~Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note."
11180113|NCT02059408|BG002|Baseline|Screen-Educate and Intensify Treatment|Screen-Educate and Intensify Treatment: This arm adds option of a pharmacist. PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education. A primary care clinical pharmacist will schedule a series of appointments with patients found to have confirmed higher-risk CKD (defined as eGFRcreat-cys <45, or eGFR 45-59 and ACR ≥ 30 mg/g). The pharmacist will follow treatment algorithms recommended by the 2012 KDIGO international CKD guidelines, and designed by a team of internists and nephrologists.
11180114|NCT02059408|BG003|Baseline|Total|Total of all reporting groups
11180115|NCT02059408|FG000|Participant Flow|Usual Care|The patients in this arm will receive normal primary care.
11234534|NCT02435966|FG002|Participant Flow|Untreated Control|Natural history of the condition
11180116|NCT02059408|FG001|Participant Flow|Screen-Educate|"Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.~Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note."
11180117|NCT02059408|FG002|Participant Flow|Screen-Educate and Intensify Treatment|The Screen-Educate and Intensify Treatment adds a pharmacist-led CKD management program and attempts to improve BP management and patient-centered outcomes among persons with newly stratified higher risk CKD based on creatinine, cystatin c and albuminuria.
11180118|NCT02059408|OG000|Outcome|Usual Care|The patients in this arm will receive normal primary care.
11180119|NCT02059408|OG001|Outcome|Screen-Educate|"Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant chronic kidney disease (CKD) management appropriate for CKD stage.~Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note."
11180120|NCT02059408|OG002|Outcome|Screen-Educate and Intensify Treatment|Screen-Educate and Intensify Treatment: Adds option of a pharmacist to what is described in the Screen-Educate arm. primary care physician (PCPs) randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education.
11180121|NCT02059408|OG002|Outcome|Screen-Educate and Intensify Treatment|Screen-Educate and Intensify Treatment: Adds option of a pharmacist to what is described in the Screen-Educate arm. PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education.
11180122|NCT02059408|OG002|Outcome|Screen-Educate and Intensify Treatment|Screen-Educate and Intensify Treatment: Adds option of a pharmacist to what is described in the Screen-Educate arm. Primary care physicians (PCPs) randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education.
11180123|NCT02059408|EG000|Reported Event|Usual Care|The patients in this arm will receive normal primary care.
11180124|NCT02059408|EG001|Reported Event|Screen-Educate|"Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.~Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note."
11180125|NCT02059408|EG002|Reported Event|Screen-Educate and Intensify Treatment|"Education and treatment program to improve blood pressure control among hypertensive non-diabetic persons. The Screen-Educate and Intensify Treatment adds a pharmacist-led CKD management program and attempts to improve BP management and patient-centered outcomes among persons with newly stratified higher risk CKD based on creatinine, cystatin c and albuminuria.~Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.~Screen-Educate and Intensify Treatment: Adds option of a pharmacist. PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education."
11180126|NCT02059434|BG000|Baseline|Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, 200 μg|All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180127|NCT02059434|BG001|Baseline|Part 1 - Cohort 1 Placebo, Then LAS190792 50 μg, 200 μg|All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence Placebo, then LAS190792 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180128|NCT02059434|BG002|Baseline|Part 1 - Cohort 1 LAS190792 5 μg, Placebo, LAS190792 200 μg|All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, Placebo, LAS190792 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180129|NCT02059434|BG003|Baseline|Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, Then Placebo|All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
11180130|NCT02059434|BG004|Baseline|Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, 400 μg|All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180131|NCT02059434|BG005|Baseline|Part 1 - Cohort 2 Placebo, Then LAS190792 100 μg, 400 μg|All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence Placebo, then LAS190792 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180132|NCT02059434|BG006|Baseline|Part 1 - Cohort 2 LAS190792 20 μg, Placebo, LAS190792 400 μg|All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, Placebo, LAS190792 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180133|NCT02059434|BG007|Baseline|Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, Then Placebo|All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
10961629|NCT00862459|FG001|Participant Flow|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961630|NCT00862459|FG002|Participant Flow|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961631|NCT00862459|OG000|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961632|NCT00862459|OG001|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961633|NCT00862459|OG002|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961634|NCT00862459|EG000|Reported Event|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961635|NCT00862459|EG001|Reported Event|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961636|NCT00862459|EG002|Reported Event|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961637|NCT00862459|EG003|Reported Event|Optimark~0.1mmol/kg BW|Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
10961638|NCT00862537|BG000|Baseline|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
10961639|NCT00862537|FG000|Participant Flow|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
10961640|NCT00862537|OG000|Outcome|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
10961641|NCT00862537|EG000|Reported Event|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
10961642|NCT00862563|BG000|Baseline|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
10961643|NCT00862563|BG001|Baseline|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
10961644|NCT00862563|BG002|Baseline|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
10961645|NCT00862563|BG003|Baseline|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
10961646|NCT00862563|BG004|Baseline|Total|Total of all reporting groups
10961647|NCT00862563|FG000|Participant Flow|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
10961648|NCT00862563|FG001|Participant Flow|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
10961649|NCT00862563|FG002|Participant Flow|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
10961650|NCT00862563|FG003|Participant Flow|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
10961651|NCT00862563|OG000|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
10961652|NCT00862563|OG001|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
10961653|NCT00862563|OG002|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
10961654|NCT00862563|OG003|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
10961655|NCT00862563|OG001|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
10961656|NCT00862563|OG002|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
11180134|NCT02059434|BG008|Baseline|Overall Population - Part 2|All individuals involved in Part 2 (single-dose study of two doses of LAS190792 [100 and 400 μg], indacaterol, tiotropium or placebo, in 5 treatment periods separated by washout periods of 7-14 days).
11180135|NCT02059434|BG009|Baseline|Total|Total of all reporting groups
11180136|NCT02059434|FG000|Participant Flow|Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, 200 μg|All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180137|NCT02059434|FG001|Participant Flow|Part 1 - Cohort 1 Placebo, Then LAS190792 50 μg, 200 μg|All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence Placebo, then LAS190792 50 μg, 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180138|NCT02059434|FG002|Participant Flow|Part 1 - Cohort 1 LAS190792 5 μg, Placebo, LAS190792 200 μg|All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, Placebo, LAS190792 200 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180139|NCT02059434|FG003|Participant Flow|Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, Then Placebo|All individuals in Part 1 - Cohort 1 who were randomised to treatment sequence LAS190792 5 μg, 50 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
11180140|NCT02059434|FG004|Participant Flow|Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, 400 μg|All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180141|NCT02059434|FG005|Participant Flow|Part 1 - Cohort 2 Placebo, Then LAS190792 100 μg, 400 μg|All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence Placebo, then LAS190792 100 μg, 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180142|NCT02059434|FG006|Participant Flow|Part 1 - Cohort 2 LAS190792 20 μg, Placebo, LAS190792 400 μg|All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, Placebo, LAS190792 400 μg in 3 treatment periods separated by washout periods of 28-42 days.
11180143|NCT02059434|FG007|Participant Flow|Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, Then Placebo|All individuals in Part 1 - Cohort 2 who were randomised to treatment sequence LAS190792 20 μg, 100 μg, then Placebo in 3 treatment periods separated by washout periods of 28-42 days.
11180144|NCT02059434|FG008|Participant Flow|Overall Population - Part 2|All individuals involved in Part 2 (single-dose study of two doses of LAS190792 [100 and 400 μg], indacaterol, tiotropium or placebo, in 5 treatment periods separated by washout periods of 7-14 days).
11180145|NCT02059434|OG000|Outcome|LAS190792 5 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180146|NCT02059434|OG001|Outcome|LAS190792 20 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180147|NCT02059434|OG002|Outcome|LAS190792 50 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180148|NCT02059434|OG003|Outcome|LAS190792 100 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180149|NCT02059434|OG004|Outcome|LAS190792 200 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180150|NCT02059434|OG005|Outcome|LAS190792 400 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180151|NCT02059434|OG006|Outcome|Placebo (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180152|NCT02059434|OG007|Outcome|LAS190792 100 µg (Part 2)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180153|NCT02059434|OG008|Outcome|LAS190792 400 µg (Part 2)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180154|NCT02059434|OG009|Outcome|Tiotropium 18 μg|Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
11180155|NCT02059434|OG010|Outcome|Indacaterol 150 μg|Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
11180156|NCT02059434|OG011|Outcome|Placebo (Part 2)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180157|NCT02059434|OG006|Outcome|LAS190792 100 µg (Part 2)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180158|NCT02059434|OG007|Outcome|LAS190792 400 µg (Part 2)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180159|NCT02059434|EG000|Reported Event|LAS190792 5 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180160|NCT02059434|EG001|Reported Event|LAS190792 20 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180161|NCT02059434|EG002|Reported Event|LAS190792 50 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180162|NCT02059434|EG003|Reported Event|LAS190792 100 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180163|NCT02059434|EG004|Reported Event|LAS190792 200 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180164|NCT02059434|EG005|Reported Event|LAS190792 400 µg (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180165|NCT02059434|EG006|Reported Event|Placebo (Part 1)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180166|NCT02059434|EG007|Reported Event|LAS190792 100 µg (Part 2)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180167|NCT02059434|EG008|Reported Event|LAS190792 400 µg (Part 2)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180168|NCT02059434|EG009|Reported Event|Tiotropium 18 μg|Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
11180169|NCT02059434|EG010|Reported Event|Indacaterol 150 μg|Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI)
11180170|NCT02059434|EG011|Reported Event|Placebo (Part 2)|Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11180171|NCT02059512|BG000|Baseline|Intramyocardial Administration 0.9 % NaCl (Sodium Chloride) - Group 0|Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.
10961657|NCT00862563|OG003|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
10961658|NCT00862563|OG000|Outcome|Zonisamide|Zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
10961659|NCT00862563|OG000|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
11180172|NCT02059512|BG001|Baseline|Intramyocardial Administration Autologous Bone Marrow Stem Cells - Group 1|Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180173|NCT02059512|BG002|Baseline|Intramyocardial and Intracoronary Administration Autologous Bone Marrow Stem Cells - Group 2|Сoronary artery bypass grafting with intramyocardial ( 0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow mononuclear cells.
11180174|NCT02059512|BG003|Baseline|Total|Total of all reporting groups
11180175|NCT02059512|FG000|Participant Flow|Intramyocardial Administration 0.9 % NaCl (Sodium Chloride) - Group 0|Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.
11180176|NCT02059512|FG001|Participant Flow|Intramyocardial Administration Autologous Bone Marrow Stem Cells - Group 1|Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180177|NCT02059512|FG002|Participant Flow|Intramyocardial and Intracoronary Administration Autologous Bone Marrow Stem Cells - Group 2|Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.
11180178|NCT02059512|OG000|Outcome|Group 0|Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.
11180179|NCT02059512|OG001|Outcome|Group 1|Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180180|NCT02059512|OG002|Outcome|Group 2|Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.
11180181|NCT02059512|OG000|Outcome|Group 0|"Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.~Сontrol group."
11180182|NCT02059512|OG000|Outcome|Group 0.|"Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.~Сontrol group."
11180183|NCT02059512|OG000|Outcome|Group 0|Coronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.
10961660|NCT00862563|OG001|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
10961661|NCT00862563|OG002|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
10961662|NCT00862563|OG003|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
10961663|NCT00862563|OG002|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
10961664|NCT00862563|EG000|Reported Event|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
11180184|NCT02059512|OG001|Outcome|Group 1|Coronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180185|NCT02059512|OG002|Outcome|Group 2|Coronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.
11180186|NCT02059512|OG001|Outcome|Group 1|Coronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180187|NCT02059512|OG002|Outcome|Group 2|Coronary artery bypass grafting with intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells intramyocardial administration 0.2 ml - 10 injection in the zone of blood supply LAD.
11180188|NCT02059512|OG000|Outcome|Intramyocardial Administration 0.9 % NaCl (Sodium Chloride) - Group 0|Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.
11180189|NCT02059512|OG001|Outcome|Intramyocardial Administration Autologous Bone Marrow Stem Cells - Group 1|Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180190|NCT02059512|OG002|Outcome|Intramyocardial and Intracoronary Administration Autologous Bone Marrow Stem Cells - Group 2|Сoronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.
11180191|NCT02059512|OG000|Outcome|Group 1|Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180192|NCT02059512|OG001|Outcome|Group 2|Сoronary artery bypass grafting with intramyocardial ( 0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow mononuclear cells.
11180193|NCT02059512|OG000|Outcome|Group 1|Coronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180194|NCT02059512|OG001|Outcome|Group 2|Coronary artery bypass grafting with intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells intramyocardial administration 0.2 ml - 10 injection in the zone of blood supply LAD.
11180195|NCT02059512|OG001|Outcome|Group 1|Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180196|NCT02059512|OG002|Outcome|Group 2|Сoronary artery bypass grafting with intramyocardial ( 0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow mononuclear cells.
11180197|NCT02059512|EG000|Reported Event|Group 0|Coronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.
11180198|NCT02059512|EG001|Reported Event|Group 1|Coronary artery bypass grafting with intramyocardial administration of autologous bone marrow stem cells 0.2 ml - 10 injection in the zone of blood supply LAD.
11180199|NCT02059512|EG002|Reported Event|Group 2|Coronary artery bypass grafting with intramyocardial (0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow stem cells.
11180200|NCT02059642|BG000|Baseline|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
11180201|NCT02059642|BG001|Baseline|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
11180202|NCT02059642|BG002|Baseline|Total|Total of all reporting groups
11180203|NCT02059642|FG000|Participant Flow|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
11180204|NCT02059642|FG001|Participant Flow|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
11180205|NCT02059642|OG000|Outcome|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
11180206|NCT02059642|OG001|Outcome|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
11180207|NCT02059642|EG000|Reported Event|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
11180208|NCT02059642|EG001|Reported Event|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
11180209|NCT02059902|BG000|Baseline|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
11180210|NCT02059902|BG001|Baseline|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
11180211|NCT02059902|BG002|Baseline|Total|Total of all reporting groups
11180212|NCT02059902|FG000|Participant Flow|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
11180213|NCT02059902|FG001|Participant Flow|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
11180214|NCT02059902|OG000|Outcome|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
11180215|NCT02059902|OG001|Outcome|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
11180216|NCT02059902|EG000|Reported Event|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
11180217|NCT02059902|EG001|Reported Event|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
11180218|NCT02059928|BG000|Baseline|Intraosseous Device Placement|"Intraosseous device~Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients"
11180219|NCT02059928|FG000|Participant Flow|Intraosseous Device Placement|"Intraosseous device~Intraosseous Device pressure measurement"
11180220|NCT02059928|OG000|Outcome|Intraosseous Device Placement|Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
11180221|NCT02059928|EG000|Reported Event|Intraosseous Device Placement|Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
11180222|NCT02059980|BG000|Baseline|Response Inhibition Training|"Eight 45-minute sessions of computerized training on response inhibition over a 4 week period~Response inhibition training: This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance"
11180223|NCT02059980|BG001|Baseline|Placebo Control Training|"Eight 45-minute sessions of computerized placebo control training over a 4 week period~Placebo Control Training: This placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities."
11180224|NCT02059980|BG002|Baseline|Total|Total of all reporting groups
11180225|NCT02059980|FG000|Participant Flow|Response Inhibition Training|"Eight 45-minute sessions of computerized training on response inhibition over a 4 week period~Response inhibition training: This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance"
10961665|NCT00862563|EG001|Reported Event|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
10961666|NCT00862563|EG002|Reported Event|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
10961667|NCT00862563|EG003|Reported Event|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
10961668|NCT00862641|BG000|Baseline|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
10961669|NCT00862641|BG001|Baseline|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
10961670|NCT00862641|BG002|Baseline|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
10961671|NCT00862641|BG003|Baseline|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
10961672|NCT00862641|BG004|Baseline|Total|Total of all reporting groups
10961673|NCT00862641|FG000|Participant Flow|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
10961674|NCT00862641|FG001|Participant Flow|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
10961675|NCT00862641|FG002|Participant Flow|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
11180226|NCT02059980|FG001|Participant Flow|Placebo Control Training|"Eight 45-minute sessions of computerized placebo control training over a 4 week period~Placebo Control Training: This placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities."
11180227|NCT02059980|OG000|Outcome|Response Inhibition Training|"Eight 45-minute sessions of computerized training on response inhibition over a 4 week period~Response inhibition training: This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance"
11180228|NCT02059980|OG001|Outcome|Placebo Control Training|"Eight 45-minute sessions of computerized placebo control training over a 4 week period~Placebo Control Training: This placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities."
10961676|NCT00862641|FG003|Participant Flow|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
10961677|NCT00862641|OG000|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
10961678|NCT00862641|OG001|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
10961679|NCT00862641|OG002|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
10961680|NCT00862641|OG003|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
10961681|NCT00862641|EG000|Reported Event|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
10961682|NCT00862641|EG001|Reported Event|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
10961683|NCT00862641|EG002|Reported Event|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
10961684|NCT00862641|EG003|Reported Event|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
10961685|NCT00862654|BG000|Baseline|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
10961686|NCT00862654|BG001|Baseline|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
10961687|NCT00862654|BG002|Baseline|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
10961688|NCT00862654|BG003|Baseline|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
10961689|NCT00862654|BG004|Baseline|Total|Total of all reporting groups
10961690|NCT00862654|FG000|Participant Flow|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
10961691|NCT00862654|FG001|Participant Flow|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
10961692|NCT00862654|FG002|Participant Flow|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
10961693|NCT00862654|FG003|Participant Flow|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
10961694|NCT00862654|OG000|Outcome|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
10961695|NCT00862654|OG001|Outcome|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
10961696|NCT00862654|OG002|Outcome|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
10961697|NCT00862654|OG003|Outcome|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
10961698|NCT00862654|EG000|Reported Event|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
10961699|NCT00862654|EG001|Reported Event|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
10961700|NCT00862654|EG002|Reported Event|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
10961701|NCT00862654|EG003|Reported Event|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
10961702|NCT00862719|BG000|Baseline|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
10961703|NCT00862719|BG001|Baseline|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
10961704|NCT00862719|BG002|Baseline|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
10961705|NCT00862719|BG003|Baseline|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
10961706|NCT00862719|BG004|Baseline|Total|Total of all reporting groups
10961707|NCT00862719|FG000|Participant Flow|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
10961708|NCT00862719|FG001|Participant Flow|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
10961709|NCT00862719|FG002|Participant Flow|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
10961710|NCT00862719|FG003|Participant Flow|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
10961711|NCT00862719|OG000|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
10961712|NCT00862719|OG001|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
11180229|NCT02059980|EG000|Reported Event|Response Inhibition Training|"Eight 45-minute sessions of computerized training on response inhibition over a 4 week period~Response inhibition training: This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance"
11180230|NCT02059980|EG001|Reported Event|Placebo Control Training|"Eight 45-minute sessions of computerized placebo control training over a 4 week period~Placebo Control Training: This placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities."
11180231|NCT02059993|BG000|Baseline|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
11180232|NCT02059993|BG001|Baseline|Control|The control group received the standardized antihypertensive medications but without receiving CPAP machine.
11180233|NCT02059993|BG002|Baseline|Total|Total of all reporting groups
11180234|NCT02059993|FG000|Participant Flow|Continuous Positive Airway Pressure(CPAP) Group|The continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure and the the cardiovascular drugs based on the guidelines.
11180235|NCT02059993|FG001|Participant Flow|Control|The controls only received the cardiovascular drugs based on the guidelines but without continuous positive airway pressure machine.
11180236|NCT02059993|OG000|Outcome|Continuous Positive Airway Pressure(CPAP) Group|The subjects who received CPAP treatment and standardized medicine.
11180237|NCT02059993|OG001|Outcome|Control|The patients who use standardized drugs without CPAP machine.
11180238|NCT02059993|EG000|Reported Event|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for 1 night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
10961713|NCT00862719|OG002|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
10961714|NCT00862719|OG003|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
10961715|NCT00862719|EG000|Reported Event|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
10961716|NCT00862719|EG001|Reported Event|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
10961717|NCT00862719|EG002|Reported Event|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
10961718|NCT00862719|EG003|Reported Event|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
10961719|NCT00862745|BG000|Baseline|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
10961720|NCT00862745|BG001|Baseline|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
10961721|NCT00862745|BG002|Baseline|Total|Total of all reporting groups
10961722|NCT00862745|FG000|Participant Flow|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
10961723|NCT00862745|FG001|Participant Flow|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
10961724|NCT00862745|OG000|Outcome|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
10961725|NCT00862745|OG001|Outcome|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
10961726|NCT00862745|EG000|Reported Event|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
10961727|NCT00862745|EG001|Reported Event|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
10961728|NCT00862784|BG000|Baseline|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
10963890|NCT00874770|OG001|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11180239|NCT02059993|EG001|Reported Event|Control|The control subjects received standardised anti-hypertension medications according to the current guildline.
11180240|NCT02060058|BG000|Baseline|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
11180241|NCT02060058|BG001|Baseline|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
11180242|NCT02060058|BG002|Baseline|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
11180243|NCT02060058|BG003|Baseline|Total|Total of all reporting groups
11180244|NCT02060058|FG000|Participant Flow|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
11180245|NCT02060058|FG001|Participant Flow|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
11180246|NCT02060058|FG002|Participant Flow|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
11180247|NCT02060058|OG000|Outcome|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
11180248|NCT02060058|OG001|Outcome|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
11180249|NCT02060058|OG002|Outcome|Null Responder or Cirrhotic Patients|"For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.~Stop trial intervention for boceprevir, PEG-IFN and RBV: Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.~Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.~Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped."
11180250|NCT02060058|OG002|Outcome|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
11180251|NCT02060058|EG000|Reported Event|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
11180252|NCT02060058|EG001|Reported Event|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
11180253|NCT02060058|EG002|Reported Event|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
11180254|NCT02060370|BG000|Baseline|Sunitinib|"Sunitinib starting dose 50 mg by mouth daily given for 2 weeks on followed by 1 week off. 1 cycle is 6 weeks.~Sunitinib: Starting dose: 50 mg by mouth daily given for 2 weeks on followed by 1 week off. 1 cycle is 6 weeks.~Questionnaire: Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6."
10961729|NCT00862784|FG000|Participant Flow|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
10961730|NCT00862784|OG000|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
10961731|NCT00862784|EG000|Reported Event|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
10961732|NCT00862810|BG000|Baseline|Received HPV Vaccine First|Received HPV vaccine first
10961733|NCT00862810|BG001|Baseline|Received Concomitant Vaccines First|Received concomitant vaccines first
10961734|NCT00862810|BG002|Baseline|Total|Total of all reporting groups
10961735|NCT00862810|FG000|Participant Flow|Received HPV Vaccine First|Received HPV vaccine first
11180255|NCT02060370|FG000|Participant Flow|Alternating Sunitinib|Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
11180256|NCT02060370|OG000|Outcome|Alternating Sunitinib|Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
11180257|NCT02060370|EG000|Reported Event|Sunitinib|"Sunitinib starting dose 50 mg by mouth daily given for 2 weeks on followed by 1 week off. 1 cycle is 6 weeks.~Sunitinib: Starting dose: 50 mg by mouth daily given for 2 weeks on followed by 1 week off. 1 cycle is 6 weeks.~Questionnaire: Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6."
11180258|NCT02060383|BG000|Baseline|Incretin Based Therapy (Randomized Group)|Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin
11180259|NCT02060383|BG001|Baseline|Insulin (Randomized Group)|Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin.
11180260|NCT02060383|BG002|Baseline|Baseline Insulin (BL) (Non-randomized Group)|This group included participants who were receiving insulin at study entry.
11180261|NCT02060383|BG003|Baseline|Oral Antidiabetic Drugs (OAD) (Non-randomized Group)|This group included participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment. Patients in this group did not require additional treatment with either incretin or insulin.
11180262|NCT02060383|BG004|Baseline|No OAD (Non-randomized Group)|This group included participants who did not receive any anti-diabetic medication during the Core Phase of the study as they did not develop hyperglycemia.
11180263|NCT02060383|BG005|Baseline|Total|Total of all reporting groups
11180264|NCT02060383|FG000|Participant Flow|Incretin Based Therapy (Randomized Group)|Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin
11180265|NCT02060383|FG001|Participant Flow|Insulin (Randomized Group)|Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin.
11180266|NCT02060383|FG002|Participant Flow|Baseline Insulin (BL) (Non-randomized Group)|This group included participants who were receiving insulin at study entry.
11180267|NCT02060383|FG003|Participant Flow|Oral Antidiabetic Drugs (OAD) (Non-randomized Group)|This group included participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment. Patients in this group did not require additional treatment with either incretin or insulin.
11180268|NCT02060383|FG004|Participant Flow|No OAD (Non-randomized Group)|This group included participants who did not receive any anti-diabetic medication during the Core Phase of the study as they did not develop hyperglycemia.
10961736|NCT00862810|FG001|Participant Flow|Received Concomitant Vaccines First|Received Concomitant Vaccines First
10961737|NCT00862810|OG000|Outcome|Received HPV Vaccine First|Received HPV vaccine first
10961738|NCT00862810|OG001|Outcome|Received Concomitant Vaccines First|Received concomitant vaccines first
10961739|NCT00862810|EG000|Reported Event|Received HPV Vaccine First|Received HPV vaccine first
10961740|NCT00862810|EG001|Reported Event|Received Concomitant Vaccines First|Received concomitant vaccines first
11180269|NCT02060383|OG000|Outcome|Incretin Based Therapy (Randomized Group)|Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin
11180270|NCT02060383|OG001|Outcome|Insulin (Randomized Group)|Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin.
11180271|NCT02060383|OG002|Outcome|Baseline Insulin (BL) (Non-randomized Group)|This group included participants who were receiving insulin at study entry.
11180272|NCT02060383|OG003|Outcome|Oral Antidiabetic Drugs (OAD) (Non-randomized Group)|This group included participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment. Patients in this group did not require additional treatment with either incretin or insulin.
11180273|NCT02060383|OG004|Outcome|No OAD (Non-randomized Group)|This group included participants who did not receive any anti-diabetic medication during the Core Phase of the study as they did not develop hyperglycemia.
11180274|NCT02060383|EG000|Reported Event|Incretin Based Therapy (Randomized Group)|Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin
11180275|NCT02060383|EG001|Reported Event|Insulin (Randomized Group)|Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin.
11180276|NCT02060383|EG002|Reported Event|Baseline Insulin (BL) (Non-randomized Group)|This group included participants who were receiving insulin at study entry.
11180277|NCT02060383|EG003|Reported Event|Oral Antidiabetic Drugs (OAD) (Non-randomized Group)|This group included participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment. Patients in this group did not require additional treatment with either incretin or insulin.
11180278|NCT02060383|EG004|Reported Event|No OAD (Non-randomized Group)|This group included participants who did not receive any anti-diabetic medication during the Core Phase of the study as they did not develop hyperglycemia.
11180279|NCT02060461|BG000|Baseline|Comparison of Femtosecond Lasers in LASIK|Outcomes of femtosecond-assisted LASIK will be compared between yes in subjects using the FS200 laser in one eye and the IntraLase in the other.
11180280|NCT02060461|FG000|Participant Flow|Comparison of Femtosecond Lasers in LASIK|Outcomes of femtosecond-assisted LASIK will be compared between yes in subjects using the FS200 femtosecond laser in one eye and the IntraLase in the other.
11180281|NCT02060461|OG000|Outcome|FS200 Femtosecond Laser LASIK|FS200 laser used to create LASIK flap
11180282|NCT02060461|OG001|Outcome|IntraLase Femtosecond Laser LASIK|IntraLase femtosecond laser used to create LASIK flap
11180283|NCT02060461|EG000|Reported Event|FS200 Femtosecond Laser LASIK|FS200 femtosecond laser used to create LASIK flap
11180284|NCT02060461|EG001|Reported Event|IntraLase Femotsecond Laser LASIK|IntraLase femtosecond laser used to create LASIK flap
11180285|NCT02060526|BG000|Baseline|No HGT-1410|Participants received no treatment (HGT-1410).
11180286|NCT02060526|BG001|Baseline|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
11180287|NCT02060526|BG002|Baseline|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
11180288|NCT02060526|BG003|Baseline|Total|Total of all reporting groups
11180289|NCT02060526|FG000|Participant Flow|No HGT-1410|Participants received no treatment (HGT-1410).
11180290|NCT02060526|FG001|Participant Flow|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 milligram (mg) intrathecally once every two weeks (Q2W) using surgically implanted intrathecal drug delivery device (IDDD) or lumbar puncture (LP) for 48 weeks.
11180291|NCT02060526|FG002|Participant Flow|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally once every four weeks (Q4W) using surgically implanted IDDD or LP for 48 weeks.
11180292|NCT02060526|OG000|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
11180293|NCT02060526|OG001|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
11180294|NCT02060526|OG002|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
11180295|NCT02060526|OG000|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
11180296|NCT02060526|OG001|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
11180297|NCT02060526|EG000|Reported Event|No HGT-1410|Participants received no treatment (HGT-1410).
11180298|NCT02060526|EG001|Reported Event|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
11180299|NCT02060526|EG002|Reported Event|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
11180300|NCT02060539|BG000|Baseline|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
10961741|NCT00862823|BG000|Baseline|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
10961742|NCT00862823|FG000|Participant Flow|Tablet First, Then Liquid|Single dose of Atripla tablet in first intervention period and Single dose of Atripla liquid in second intervnetion period
10961743|NCT00862823|FG001|Participant Flow|Liquid First, Then Tablet|Single dose of Atripla liquid in first intervention period and single dose of Atripla tablet in second intervnetion period
11180301|NCT02060539|FG000|Participant Flow|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
11180302|NCT02060539|OG000|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
11180303|NCT02060539|EG000|Reported Event|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
11180304|NCT02060838|BG000|Baseline|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
11180305|NCT02060838|BG001|Baseline|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
11180306|NCT02060838|BG002|Baseline|Total|Total of all reporting groups
11180307|NCT02060838|FG000|Participant Flow|ANH Collected & Stored in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
11180308|NCT02060838|FG001|Participant Flow|ANH Collected & Stored in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
11180309|NCT02060838|OG000|Outcome|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
11180310|NCT02060838|OG001|Outcome|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
11180311|NCT02060838|EG000|Reported Event|ANH Blood Collected & Stored in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
11180312|NCT02060838|EG001|Reported Event|ANH Blood Collected & Stored in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
11180313|NCT02060890|BG000|Baseline|Group A|"Patients will undergo collection of tumor at the time of tumor resection and after confirmation of tumor progression and will have blood samples drawn pre-surgery and during standard of care follow-up visits. Patients will then be provided with a specialized tumor board recommendations for personalized treatment options for up to 4 medications based on the specimen analysis results within 35 days of surgery. Patients may then elect to initiate recommended therapy within 42 days of surgery.~specialized tumor board recommendation: feasibility of a specialized tumor board to come up with treatment recommendations no later than 35 days from surgery."
11180314|NCT02060890|FG000|Participant Flow|Treatment Group|"Patients will undergo collection of tumor at the time of tumor resection and after confirmation of tumor progression and will have blood samples drawn pre-surgery and during standard of care follow-up visits. Patients will then be provided with a specialized tumor board recommendations for personalized treatment options for up to 4 medications based on the specimen analysis results within 35 days of surgery. Patients may then elect to initiate recommended therapy within 42 days of surgery.~specialized tumor board recommendation: feasibility of a specialized tumor board to come up with treatment recommendations no later than 35 days from surgery."
11180315|NCT02060890|OG000|Outcome|Group A|
11180316|NCT02060890|OG000|Outcome|Treatment Group|
11180317|NCT02060890|EG000|Reported Event|Group A|Patients pursuing treatment after tumor board's genomics-informed treatment recommendation.
11180318|NCT02060903|BG000|Baseline|Abametapir Lotion 0.74% w/w|"Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.~Abametapir Lotion 0.74% w/w"
11180319|NCT02060903|BG001|Baseline|Vehicle Lotion|"Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.~Vehicle Lotion"
11180320|NCT02060903|BG002|Baseline|Total|Total of all reporting groups
11180321|NCT02060903|FG000|Participant Flow|Abametapir Lotion 0.74% w/w|"Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.~Abametapir Lotion 0.74% w/w"
11180322|NCT02060903|FG001|Participant Flow|Vehicle Lotion|"Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.~Vehicle Lotion"
11180323|NCT02060903|OG000|Outcome|Abametapir Lotion 0.74% w/w|"Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.~Abametapir Lotion 0.74% w/w"
11180324|NCT02060903|OG001|Outcome|Vehicle Lotion|"Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.~Vehicle Lotion"
11180325|NCT02060903|EG000|Reported Event|Abametapir Lotion 0.74% w/w|"Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.~Abametapir Lotion 0.74% w/w"
10961744|NCT00862823|OG000|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
11180326|NCT02060903|EG001|Reported Event|Vehicle Lotion|"Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.~Vehicle Lotion"
11180327|NCT02061202|BG000|Baseline|Mometasone Furoate|1 puff daily (220mcg) for 16 weeks
11180328|NCT02061202|BG001|Baseline|Placebo|1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
11180329|NCT02061202|BG002|Baseline|Total|Total of all reporting groups
11180330|NCT02061202|FG000|Participant Flow|Mometasone Furoate|1 puff daily (220mcg) for 16 weeks
11180331|NCT02061202|FG001|Participant Flow|Placebo|1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
11180332|NCT02061202|OG000|Outcome|Mometasone Furoate|1 puff daily (220mcg) for 16 weeks
11180333|NCT02061202|OG001|Outcome|Placebo|1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
11180334|NCT02061202|EG000|Reported Event|Mometasone Furoate|1 puff daily (220mcg) for 16 weeks
11180335|NCT02061202|EG001|Reported Event|Placebo|1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
11180336|NCT02061280|BG000|Baseline|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180337|NCT02061280|BG001|Baseline|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180338|NCT02061280|BG002|Baseline|Total|Total of all reporting groups
11180339|NCT02061280|FG000|Participant Flow|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180340|NCT02061280|FG001|Participant Flow|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180341|NCT02061280|OG000|Outcome|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
10961745|NCT00862823|OG001|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
10961746|NCT00862823|EG000|Reported Event|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
10961747|NCT00862836|BG000|Baseline|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
11180342|NCT02061280|OG001|Outcome|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180343|NCT02061280|OG000|Outcome|MICT Trial Design|"MICT Trial:~Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180344|NCT02061280|OG000|Outcome|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180345|NCT02061280|OG001|Outcome|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily."
11180346|NCT02061280|EG000|Reported Event|MICT Trial Design|"MICT Trial:~Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180347|NCT02061280|EG001|Reported Event|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
11180348|NCT02061358|BG000|Baseline|3 mg UV-4B|UV-4B 3 mg oral, single dose
11180349|NCT02061358|BG001|Baseline|10 mg UV-4B|UV-4B 10 mg oral, single dose
11180350|NCT02061358|BG002|Baseline|30 mg UV-4B|UV-4B 30 mg oral, single dose
11180351|NCT02061358|BG003|Baseline|90 mg UV-4B|UV-4B 90 mg oral, single dose
11180352|NCT02061358|BG004|Baseline|180 mg UV-4B|UV-4B 180 mg oral, single dose
11180353|NCT02061358|BG005|Baseline|360 mg UV-4B|UV-4B 360 mg oral, single dose
11180354|NCT02061358|BG006|Baseline|720 mg UV-4B|UV-4B 720 mg oral, single dose
11180355|NCT02061358|BG007|Baseline|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
11180356|NCT02061358|BG008|Baseline|Placebo|Placebo oral, single dose
11180357|NCT02061358|BG009|Baseline|Total|Total of all reporting groups
11180358|NCT02061358|FG000|Participant Flow|3 mg UV-4B|UV-4B 3 mg oral, single dose
11180359|NCT02061358|FG001|Participant Flow|10 mg UV-4B|UV-4B 10 mg oral, single dose
11180360|NCT02061358|FG002|Participant Flow|30 mg UV-4B|UV-4B 30 mg oral, single dose
11180361|NCT02061358|FG003|Participant Flow|90 mg UV-4B|UV-4B 90 mg oral, single dose
11180362|NCT02061358|FG004|Participant Flow|180 mg UV-4B|UV-4B 180 mg oral, single dose
11180363|NCT02061358|FG005|Participant Flow|360 mg UV-4B|UV-4B 360 mg oral, single dose
11180364|NCT02061358|FG006|Participant Flow|720 mg UV-4B|UV-4B 720 mg oral, single dose
11180365|NCT02061358|FG007|Participant Flow|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
10961748|NCT00862836|FG000|Participant Flow|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
11180366|NCT02061358|FG008|Participant Flow|Placebo|Placebo oral, single dose
11180367|NCT02061358|OG000|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
11180368|NCT02061358|OG001|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
11180369|NCT02061358|OG002|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
11180370|NCT02061358|OG003|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
11180371|NCT02061358|OG004|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
11180372|NCT02061358|OG005|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
11180373|NCT02061358|OG006|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
11180374|NCT02061358|OG007|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
11180375|NCT02061358|OG008|Outcome|Placebo|Placebo oral, single dose
11180376|NCT02061358|EG000|Reported Event|3 mg UV-4B|UV-4B 3 mg oral, single dose
11180377|NCT02061358|EG001|Reported Event|10 mg UV-4B|UV-4B 10 mg oral, single dose
11180378|NCT02061358|EG002|Reported Event|30 mg UV-4B|UV-4B 30 mg oral, single dose
11180379|NCT02061358|EG003|Reported Event|90 mg UV-4B|UV-4B 90 mg oral, single dose
11180380|NCT02061358|EG004|Reported Event|180 mg UV-4B|UV-4B 180 mg oral, single dose
11180381|NCT02061358|EG005|Reported Event|360 mg UV-4B|UV-4B 360 mg oral, single dose
11180382|NCT02061358|EG006|Reported Event|720 mg UV-4B|UV-4B 720 mg oral, single dose
11180383|NCT02061358|EG007|Reported Event|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
11180384|NCT02061358|EG008|Reported Event|Placebo|Placebo oral, single dose
11180385|NCT02061384|BG000|Baseline|13-cis Retinoic Acid|"20mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks~13-cis retinoic acid: Accutane is used for the treatment of severe acne"
11180386|NCT02061384|BG001|Baseline|13-cis Retinoic Acid + Calcitriol 0.25 mcg|"oral calcitriol 025 mcg BID subjects 11-20 for 20 weeks~Calcitriol: Calcitriol is a form of vitamin D given twice daily (BID)"
11180387|NCT02061384|BG002|Baseline|Total|Total of all reporting groups
11180388|NCT02061384|FG000|Participant Flow|13-cis Retinoic Acid + Oral Calcitriol|20 mg 13-cis retinoic acid twice daily (BID) with meals for two weeks + oral calcitriol 0.25 mcg BID
11180389|NCT02061384|FG001|Participant Flow|13-cis Retinoic Acid|20 mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks
11180390|NCT02061384|OG000|Outcome|13-cis Retinoic Acid|"20mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks~13-cis retinoic acid: Accutane is used for the treatment of severe acne"
11180391|NCT02061384|OG001|Outcome|Calcitriol 0.25 mcg|"oral calcitriol 025 mcg BID subjects 11-20 for 20 weeks~Calcitriol: Calcitriol is a form of vitamin D given twice daily (BID)"
11180392|NCT02061384|EG000|Reported Event|13-cis Retinoic Acid + Oral Calcitriol|20 mg 13-cis retinoic acid twice daily (BID) with meals for two weeks + oral calcitriol 0.25 mcg BID
11180393|NCT02061384|EG001|Reported Event|13-cis Retinoic Acid|20 mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks
11180394|NCT02061397|BG000|Baseline|Single Simvastatin Treatment Arm|"Simvastatin 20 mg oral daily for 2 months; if tolerated, followed by simvastatin 40 mg oral daily for 2 months~Simvastatin: Eligible patients will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4."
11180395|NCT02061397|FG000|Participant Flow|Single Simvastatin Treatment Arm|"Simvastatin 20 mg oral daily for 2 months; if tolerated, followed by simvastatin 40 mg oral daily for 2 months~Simvastatin: Eligible patients will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4."
11234535|NCT02435966|OG000|Outcome|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
11234536|NCT02435966|OG001|Outcome|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
11234537|NCT02435966|OG002|Outcome|Untreated Control|Natural history of the condition
11234538|NCT02435966|EG000|Reported Event|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
11234539|NCT02435966|EG001|Reported Event|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
11234540|NCT02435966|EG002|Reported Event|Untreated Control|Natural history of the condition
11234541|NCT02435992|BG000|Baseline|RPC1063 Cohort 1(Induction Period)|"Blinded~On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)~On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)~On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)"
11234542|NCT02435992|BG001|Baseline|Placebo Cohort 1 (Induction Period)|-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
11234543|NCT02435992|BG002|Baseline|RPC1063 Cohort 2 (Induction Period)|"Open Label~On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)~On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)~On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)"
11234544|NCT02435992|BG003|Baseline|RPC1063 (Maintenance Period)|- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
11234545|NCT02435992|BG004|Baseline|Placebo (Maintenance Period)|- Blinded Placebo
11234546|NCT02435992|BG005|Baseline|Total|Total of all reporting groups
11234547|NCT02435992|FG000|Participant Flow|RPC1063 Cohort 1 (Induction Period)|"Blinded~On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)~On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)~On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)"
11234548|NCT02435992|FG001|Participant Flow|Placebo Cohort 1 (Induction Period)|-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
11234549|NCT02435992|FG002|Participant Flow|RPC1063 Cohort 2 (Induction Period)|"Open Label~On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)~On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)~On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)"
11234550|NCT02435992|FG003|Participant Flow|RPC1063 (Maintenance Period)|- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
11234551|NCT02435992|FG004|Participant Flow|Placebo (Maintenance Period)|- Blinded Placebo
11234552|NCT02435992|OG000|Outcome|RPC1063 Cohort 1(Induction Period)|"Blinded~On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)~On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)~On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)"
11234553|NCT02435992|OG001|Outcome|Placebo Cohort 1 (Induction Period)|-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
10961749|NCT00862836|OG000|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
11234554|NCT02435992|OG002|Outcome|RPC1063 Cohort 2 (Induction Period)|"Open Label~On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)~On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)~On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)"
11234555|NCT02435992|OG003|Outcome|RPC1063 (Maintenance Period)|- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
11234556|NCT02435992|OG004|Outcome|Placebo (Maintenance Period)|- Blinded Placebo
11234557|NCT02435992|EG000|Reported Event|Cohort 1 (Induction Period): RPC1063 1mg|Cohort 1 (Induction Period): RPC1063 1mg
11234558|NCT02435992|EG001|Reported Event|Cohort 1: Placebo|Cohort 1: Placebo
10961750|NCT00862836|EG000|Reported Event|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
10963891|NCT00874770|OG000|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Riibavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11234559|NCT02435992|EG002|Reported Event|Cohort 2 (Induction Period): RPC1063 1mg|Cohort 2 (Induction Period): RPC1063 1mg
11234560|NCT02435992|EG003|Reported Event|Intervention (Maintenance Period): RPC1063 1mg|Intervention (Maintenance Period): RPC1063 1mg
11234561|NCT02435992|EG004|Reported Event|Placebo (Maintenance Period): Placebo|Placebo (Maintenance Period): Placebo
11234562|NCT02436005|BG000|Baseline|Overall Study|"Subjects will be randomized to wear the Phenacite and comfilcon A contact lenses binocularly for two weeks.~Phenacite: contact lenses (Not the final Design - Further clinical studies were conducted to validate the new design)~comfilcon A: contact lenses"
11234563|NCT02436005|FG000|Participant Flow|Phenacite Then Comfilcon A|"Subjects will be randomized to wear the Phenacite contact lenses binocularly for two weeks then cross-over to comfilcon A lenses for two weeks.~Phenacite: contact lenses comfilcon A: Contact Lenses"
11234564|NCT02436005|FG001|Participant Flow|Comfilcon A Then Phenacite|"Subjects will be randomized to wear comfilcon A contact lenses for two weeks then cross-over to Phenacite Lenses for two weeks.~comfilcon A: Contact Lenses Phenacite : Contact Lenses"
11234565|NCT02436005|OG000|Outcome|Phenacite|"Subjects will be randomized to wear the Phenacite contact lenses binocularly.~Phenacite: contact lenses"
11234566|NCT02436005|OG001|Outcome|Comfilcon A|"Subjects will be randomized to wear the comfilcon A contact lenses binocularly.~comfilcon A: contact lenses"
11234567|NCT02436005|EG000|Reported Event|Phenacite|"Subjects will be randomized to wear the Phenacite contact lenses binocularly for two weeks.~Phenacite: contact lenses"
11234568|NCT02436005|EG001|Reported Event|Comfilcon A|"Subjects will be randomized to wear comfilcon A contact lenses binocularly for two weeks.~comfilcon A: contact lenses binocularly."
11234569|NCT02436031|BG000|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.
11234570|NCT02436031|FG000|Participant Flow|Desipramine First, Placebo Second|Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
11234571|NCT02436031|FG001|Participant Flow|Placebo First, Desipramine Second|Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
11234572|NCT02436031|OG000|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
11234573|NCT02436031|OG001|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
11234574|NCT02436031|EG000|Reported Event|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
11234575|NCT02436031|EG001|Reported Event|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
11234576|NCT02436135|BG000|Baseline|Cohort A, Idelalisib + Ruxolitinib|Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
11234577|NCT02436135|BG001|Baseline|Cohort B, Idelalisib + Ruxolitinib|Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
11234578|NCT02436135|BG002|Baseline|Total|Total of all reporting groups
11234579|NCT02436135|FG000|Participant Flow|Cohort A, Idelalisib + Ruxolitinib|Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for primary myelofibrosis (PMF), post- polycythemia vera (PV) myelofibrosis (MF), or post-essential thrombocythemia (ET) MF.
11234580|NCT02436135|FG001|Participant Flow|Cohort B, Idelalisib + Ruxolitinib|Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
11234581|NCT02436135|OG000|Outcome|Cohort A, Idelalisib + Ruxolitinib|Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
11234582|NCT02436135|OG001|Outcome|Cohort B, Idelalisib + Ruxolitinib|Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
11234583|NCT02436135|EG000|Reported Event|Cohort A, Idelalisib + Ruxolitinib|Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
11234584|NCT02436135|EG001|Reported Event|Cohort B, Idelalisib + Ruxolitinib|Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
11234585|NCT02436200|BG000|Baseline|Intervention|"Patients receiving neuromuscular electrical stimulation.~Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol."
11234586|NCT02436200|FG000|Participant Flow|Intervention|"Patients receiving neuromuscular electrical stimulation.~Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol."
11234587|NCT02436200|OG000|Outcome|Intervention|"Patients receiving neuromuscular electrical stimulation.~Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol."
11234588|NCT02436200|EG000|Reported Event|Intervention|"Patients receiving neuromuscular electrical stimulation.~Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol."
11234589|NCT02436239|BG000|Baseline|Placebo/Vilazodone|Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234590|NCT02436239|BG001|Baseline|Vilazodone/Vilazodone|Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234591|NCT02436239|BG002|Baseline|Fluoxetine/Vilazodone|Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234592|NCT02436239|BG003|Baseline|De Novo/Vilazodone|Newly enrolled participants received vilazodone tablets once daily, oral administration.
11180396|NCT02061397|OG000|Outcome|Single Simvastatin Treatment Arm|"Simvastatin 20 mg oral daily for 2 months; if tolerated, followed by simvastatin 40 mg oral daily for 2 months~Simvastatin: Eligible patients will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4."
11180397|NCT02061397|EG000|Reported Event|Single Simvastatin Treatment Arm|"Simvastatin 20 mg oral daily for 2 months; if tolerated, followed by simvastatin 40 mg oral daily for 2 months~Simvastatin: Eligible patients will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4."
11180398|NCT02061540|BG000|Baseline|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
11180399|NCT02061540|FG000|Participant Flow|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
11180400|NCT02061540|OG000|Outcome|Maralixibat (LUM001) 1 mg|Participants received LUM001 tablet orally once daily at a dose of 1 mg during Week 2 of the treatment period.
11180401|NCT02061540|OG001|Outcome|Maralixibat (LUM001) 2.5 mg|Participants received LUM001 tablet orally once daily at a dose of 2.5 mg during Week 3 of the treatment period.
11180402|NCT02061540|OG002|Outcome|Maralixibat (LUM001) 5 mg|Participants received LUM001 tablet orally once daily at a dose of 5 mg during Week 4 of the treatment period.
11180403|NCT02061540|OG003|Outcome|Maralixibat (LUM001) 7.5 mg|Participants received LUM001 tablet orally once daily at a dose of 7.5 mg during Week 5 of the treatment period.
11180404|NCT02061540|OG004|Outcome|Maralixibat (LUM001) 10 mg|Participants received LUM001 tablet orally once daily at a dose of 10 mg during Week 6 of the treatment period followed by stable dosing of 10 mg for 8 weeks.
11180405|NCT02061540|OG000|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
11180406|NCT02061540|EG000|Reported Event|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
11180407|NCT02061592|BG000|Baseline|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
11180408|NCT02061592|BG001|Baseline|Test/Control|Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
11180409|NCT02061592|BG002|Baseline|Total|Total of all reporting groups
11180410|NCT02061592|FG000|Participant Flow|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
11180411|NCT02061592|FG001|Participant Flow|Test/Control|Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
11180412|NCT02061592|OG000|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
11180413|NCT02061592|OG001|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
11180414|NCT02061592|OG001|Outcome|Test|Subjects who received Test lens, etafilcon A, in either the first week or last week of the study.
11180415|NCT02061592|OG001|Outcome|Test|Subjects who received Test lens, etafilcon A , in either the first week or last week of the study.
11180416|NCT02061592|EG000|Reported Event|Control|Subjects who received control lens etafilcon A in either the first or the last week of the study .
11180417|NCT02061592|EG001|Reported Event|Test|Subjects who received the test lens, etafilcon A, in either the first week or the last week of the study.
11180418|NCT02061683|BG000|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
11180419|NCT02061683|FG000|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
11180420|NCT02061683|OG000|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
11180421|NCT02061683|EG000|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
11180422|NCT02061696|BG000|Baseline|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
11180423|NCT02061696|BG001|Baseline|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
11180424|NCT02061696|BG002|Baseline|Total|Total of all reporting groups
11180425|NCT02061696|FG000|Participant Flow|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
11180426|NCT02061696|FG001|Participant Flow|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
11180427|NCT02061696|OG000|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
10961751|NCT00862849|BG000|Baseline|All Participants|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C).~Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Intervention B: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~Intervention C: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions.~The treatment sequence (ABC, ACB, BAC, BCA, CAB, or CBA) was repeated once so that each participant received up to 6 injections."
11180428|NCT02061696|OG001|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
11180429|NCT02061696|EG000|Reported Event|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
11180430|NCT02061696|EG001|Reported Event|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
11180431|NCT02061748|BG000|Baseline|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
11180432|NCT02061748|BG001|Baseline|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
11180433|NCT02061748|BG002|Baseline|Total|Total of all reporting groups
11180434|NCT02061748|FG000|Participant Flow|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
11180435|NCT02061748|FG001|Participant Flow|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
11180436|NCT02061748|OG000|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
11180437|NCT02061748|OG001|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
11180438|NCT02061748|EG000|Reported Event|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
11180439|NCT02061748|EG001|Reported Event|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
11180440|NCT02061774|BG000|Baseline|Acetaminophen|"1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours~Acetaminophen: 1 gram of intravenous Acetaminophen"
11180441|NCT02061774|BG001|Baseline|PlaceboComparator|"Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours~Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours"
11180442|NCT02061774|BG002|Baseline|Total|Total of all reporting groups
11180443|NCT02061774|FG000|Participant Flow|Acetaminophen|"1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours~Acetaminophen: 1 gram of intravenous Acetaminophen"
11180444|NCT02061774|FG001|Participant Flow|PlaceboComparator|"Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours~Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours"
11180445|NCT02061774|OG000|Outcome|Acetaminophen|"1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours~Acetaminophen: 1 gram of intravenous Acetaminophen"
11180446|NCT02061774|OG001|Outcome|PlaceboComparator|"Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours~Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours"
11180447|NCT02061774|EG000|Reported Event|Acetaminophen|"1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours~Acetaminophen: 1 gram of intravenous Acetaminophen"
11180448|NCT02061774|EG001|Reported Event|PlaceboComparator|"Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours~Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours"
11234593|NCT02436239|BG004|Baseline|Total|Total of all reporting groups
11234594|NCT02436239|FG000|Participant Flow|Placebo/Vilazodone|Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234595|NCT02436239|FG001|Participant Flow|Vilazodone/Vilazodone|Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234596|NCT02436239|FG002|Participant Flow|Fluoxetine/Vilazodone|Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234597|NCT02436239|FG003|Participant Flow|De Novo/Vilazodone|Newly enrolled participants received vilazodone tablets once daily, oral administration.
11234598|NCT02436239|OG000|Outcome|Placebo/Vilazodone|Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234599|NCT02436239|OG001|Outcome|Vilazodone/Vilazodone|Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234600|NCT02436239|OG002|Outcome|Fluoxetine/Vilazodone|Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234601|NCT02436239|OG003|Outcome|De Novo/Vilazodone|Newly enrolled participants received vilazodone tablets once daily, oral administration.
11234602|NCT02436239|EG000|Reported Event|Placebo/Vilazodone|Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234603|NCT02436239|EG001|Reported Event|Vilazodone/Vilazodone|Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234604|NCT02436239|EG002|Reported Event|Fluoxetine/Vilazodone|Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
11234605|NCT02436239|EG003|Reported Event|De Novo/Vilazodone|Newly enrolled participants received vilazodone tablets once daily, oral administration.
11234606|NCT02436304|BG000|Baseline|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
11234607|NCT02436304|BG001|Baseline|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
11234608|NCT02436304|BG002|Baseline|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
11234609|NCT02436304|BG003|Baseline|Total|Total of all reporting groups
11234610|NCT02436304|FG000|Participant Flow|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
11234611|NCT02436304|FG001|Participant Flow|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
11234612|NCT02436304|FG002|Participant Flow|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
11234613|NCT02436304|OG000|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
11234614|NCT02436304|OG001|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
11234615|NCT02436304|OG002|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
11234616|NCT02436304|EG000|Reported Event|Pretreatment|All who consented to participate in the study prior to randomization
11234617|NCT02436304|EG001|Reported Event|EXE844 7 Days|All participants exposed to EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion
11234618|NCT02436304|EG002|Reported Event|EXE844 3 Days|All participants exposed to EXE844 Sterile Otic Suspension, 0.3%, for 3 days after Tympanostomy Tube Insertion
11234619|NCT02436304|EG003|Reported Event|Tubes Only|All participants who underwent bilateral myringotomy and tympanostomy tube insertion only
11234620|NCT02436330|BG000|Baseline|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
11234621|NCT02436330|BG001|Baseline|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
11234622|NCT02436330|BG002|Baseline|Total|Total of all reporting groups
11234623|NCT02436330|FG000|Participant Flow|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period.~n = 60 (71%) enrolled within 6 cohorts over the study period from April 2011 to September 2013."
11234624|NCT02436330|FG001|Participant Flow|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period.~n = 24 (29%) enrolled within 6 cohorts during the study period from April 2011 to September 2013"
11234625|NCT02436330|OG000|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
11234626|NCT02436330|OG001|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
11234627|NCT02436330|OG000|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
11234628|NCT02436330|OG000|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
11234629|NCT02436330|OG001|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
11234630|NCT02436330|OG000|Outcome|Exergaming and Didactic Health Teaching|Subjects attending exergaming/physical activity along with classroom structured nutrition/health education.
11234631|NCT02436330|OG001|Outcome|Didactic Health Teaching|Subjects only receiving classroom structured nutrition/health education.
11234632|NCT02436330|OG000|Outcome|Exergaming and Didactic Health Teaching|Intervention group subjects (exergaming combined with didactic nutrition teaching) with continued participation at 6 months completed this questionnaire regarding attitudes/perceptions towards participation.
11234633|NCT02436330|EG000|Reported Event|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
11234634|NCT02436330|EG001|Reported Event|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
11234635|NCT02436356|BG000|Baseline|Distal Radius Fracture Operative Group|"Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.~Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234636|NCT02436356|BG001|Baseline|Healthy Volunteers (Non Fracture Group)|"Healthy volunteers will undergo DXA and MRI scans.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234637|NCT02436356|BG002|Baseline|Distal Radius Fracture Non-operative Group|"Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234638|NCT02436356|BG003|Baseline|Total|Total of all reporting groups
11234639|NCT02436356|FG000|Participant Flow|Distal Radius Fracture Operative Group|"Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.~Osteoprobe-RPI (Reference Point Indentation): Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234640|NCT02436356|FG001|Participant Flow|Healthy Volunteers (Non Fracture Group)|"Healthy volunteers will undergo DXA and MRI scans.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234641|NCT02436356|FG002|Participant Flow|Distal Radius Fracture Non-operative Group|"Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234642|NCT02436356|OG000|Outcome|Distal Radius Fracture Operative Group|"Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.~Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234643|NCT02436356|OG001|Outcome|Healthy Volunteers|"Healthy volunteers will undergo DXA and MRI scans.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
10963892|NCT00874770|OG001|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11234644|NCT02436356|OG002|Outcome|Distal Radius Fracture Non-Operative Group|"Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234645|NCT02436356|OG000|Outcome|Distal Radius Fracture Operative Group|"Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.~Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234646|NCT02436356|OG002|Outcome|Distal Radius Fracture Non-operative Group|"Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234647|NCT02436356|OG000|Outcome|Distal Radius Fracture Operative Group|"Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.~Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone."
11234648|NCT02436356|OG001|Outcome|Healthy Volunteers|Healthy volunteers will undergo DXA and MRI scans. Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone.
11234649|NCT02436356|OG002|Outcome|Distal Radius Fracture Non-operative Group|"Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone."
11234650|NCT02436356|EG000|Reported Event|Distal Radius Fracture Operative Group|"Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.~Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234651|NCT02436356|EG001|Reported Event|Healthy Volunteers (Non Fracture Group)|"Healthy volunteers will undergo DXA and MRI scans.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234652|NCT02436356|EG002|Reported Event|Distal Radius Fracture Non-operative Group|"Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.~Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk~MRI: Determines bound water and pore water of bone."
11234653|NCT02436408|BG000|Baseline|Vismodegib|150mg taken orally once daily
11234654|NCT02436408|FG000|Participant Flow|Vismodegib|150mg taken orally once daily
11234655|NCT02436408|OG000|Outcome|Vismodegib|150mg taken orally once daily
11234656|NCT02436408|EG000|Reported Event|Vismodegib|150mg taken orally once daily
11234657|NCT02436577|BG000|Baseline|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234658|NCT02436577|BG001|Baseline|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234659|NCT02436577|BG002|Baseline|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234660|NCT02436577|BG003|Baseline|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
10961752|NCT00862849|FG000|Participant Flow|Lispro+rHuPH20 First, Then RHI+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
11234661|NCT02436577|BG004|Baseline|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234662|NCT02436577|BG005|Baseline|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234663|NCT02436577|BG006|Baseline|Total|Total of all reporting groups
11234664|NCT02436577|FG000|Participant Flow|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234665|NCT02436577|FG001|Participant Flow|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234666|NCT02436577|FG002|Participant Flow|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234667|NCT02436577|FG003|Participant Flow|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234668|NCT02436577|FG004|Participant Flow|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234669|NCT02436577|FG005|Participant Flow|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
11234670|NCT02436577|OG000|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
11234671|NCT02436577|OG001|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
11234672|NCT02436577|OG002|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
11234673|NCT02436577|EG000|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
11234674|NCT02436577|EG001|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
11234675|NCT02436577|EG002|Reported Event|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
11234676|NCT02436668|BG000|Baseline|Pbo+n-P/G|"Placebo daily in combination with:~Nab-paclitaxel and gemcitabine~Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion."
11234677|NCT02436668|BG001|Baseline|Ibr+n-P/G|"Ibrutinib daily in combination with:~Nab-paclitaxel and gemcitabine~Ibrutinib- orally once daily at a starting dose of 560 mg.~Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion"
11234678|NCT02436668|BG002|Baseline|Total|Total of all reporting groups
11234679|NCT02436668|FG000|Participant Flow|Placebo+Gemcitabine+Nab-Paclitaxel|"Placebo daily in combination with:~Nab-paclitaxel and gemcitabine~Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion"
11234680|NCT02436668|FG001|Participant Flow|Ibrutinib+Gemcitabine+Nab-paclitaxel|"Ibrutinib daily in combination with:~Nab-paclitaxel and gemcitabine~Ibrutinib was administered orally once daily at a starting dose of 560 mg.~Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion."
11234681|NCT02436668|OG000|Outcome|Ibrutinib+Gemcitabine+Nab-paclitaxel|"Ibrutinib daily in combination with:~Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion."
11234682|NCT02436668|OG001|Outcome|Placebo+Gemcitabine+Nab-Paclitaxel|"Placebo daily in combination with:~Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion"
11234683|NCT02436668|OG000|Outcome|Placebo+Gemcitabine+Nab-Paclitaxel|"Placebo daily in combination with:~Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion"
11234684|NCT02436668|OG001|Outcome|Ibrutinib+Gemcitabine+Nab-paclitaxel|"Ibrutinib daily in combination with:~Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion."
11234685|NCT02436668|OG001|Outcome|Ibrutinib+Gemcitabine+Nab-paclitaxel|"Ibrutinib daily in combination with:~Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.~I"
11234686|NCT02436668|EG000|Reported Event|Placebo (Plus Nab-paclitaxel and Gemcitabine)|"Placebo daily in combination with:~Nab-paclitaxel and gemcitabine~Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion"
11234687|NCT02436668|EG001|Reported Event|Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)|"Ibrutinib 560 mg (4 x 140 mg capsules) (or placebo) was administered orally once daily beginning on Day 1 of Cycle 1 of the treatment phase, with the first dose of ibrutinib given no more than 72 hours after randomization~Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion"
11234688|NCT02436681|BG000|Baseline|MIROMESH|MIROMESH was used for laparoscopic paraesophageal hernia repair
11234689|NCT02436681|FG000|Participant Flow|MIROMESH|MIROMESH was used for laparoscopic paraesophageal hernia repair
11234690|NCT02436681|OG000|Outcome|MIROMESH|MIROMESH was used for laparoscopic paraesophageal hernia repair
11234691|NCT02436681|EG000|Reported Event|MIROMESH|MIROMESH was used for laparoscopic paraesophageal hernia repair
11234692|NCT02436759|BG000|Baseline|RVL-1201|RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning
11234693|NCT02436759|BG001|Baseline|Vehicle|Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
11234694|NCT02436759|BG002|Baseline|Total|Total of all reporting groups
11234695|NCT02436759|FG000|Participant Flow|RVL-1201|RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning
11234696|NCT02436759|FG001|Participant Flow|Vehicle|Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
11234697|NCT02436759|OG000|Outcome|RVL-1201|RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning
11234698|NCT02436759|OG001|Outcome|Vehicle Ophthalmic Solution|Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
11234699|NCT02436759|EG000|Reported Event|RVL-1201|RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning
11234700|NCT02436759|EG001|Reported Event|Vehicle|Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
11234701|NCT02436811|BG000|Baseline|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
11234702|NCT02436811|BG001|Baseline|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
11234703|NCT02436811|BG002|Baseline|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
11234704|NCT02436811|BG003|Baseline|Total|Total of all reporting groups
11234705|NCT02436811|FG000|Participant Flow|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
11234706|NCT02436811|FG001|Participant Flow|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
11234707|NCT02436811|FG002|Participant Flow|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
11234708|NCT02436811|OG000|Outcome|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
11234709|NCT02436811|OG001|Outcome|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
11234710|NCT02436811|OG002|Outcome|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
11234711|NCT02436811|EG000|Reported Event|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
11234712|NCT02436811|EG001|Reported Event|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
11234713|NCT02436811|EG002|Reported Event|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
11234714|NCT02436876|BG000|Baseline|MBN-101 0.5 µg/cm2|"Single, intra-wound local administration of MBN-101; randomized 3:1 with placebo~MBN-101 is a locally administered, anti-infective drug product"
11234715|NCT02436876|BG001|Baseline|MBN-101 1.5 µg/cm2|"Single, intra-wound local administration of MBN-101; randomized 3:1 with placebo~MBN-101 is a locally administered, anti-infective drug product"
11234716|NCT02436876|BG002|Baseline|MBN-101 5.0 µg/cm2|"Single, intra-wound local administration of MBN-101; randomized 3:1 with placebo~MBN-101 is a locally administered, anti-infective drug product"
11234717|NCT02436876|BG003|Baseline|Placebo|Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo subjects were randomized 1:3 with subjects treated with active.
11234718|NCT02436876|BG004|Baseline|Total|Total of all reporting groups
11234719|NCT02436876|FG000|Participant Flow|MBN-101 0.5 µg/cm2|"Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234720|NCT02436876|FG001|Participant Flow|MBN-101 1.5 µg/cm2|"Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234721|NCT02436876|FG002|Participant Flow|MBN-101 5.0 µg/cm2|"Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234722|NCT02436876|FG003|Participant Flow|Placebo|Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo subjects were randomized 1:3 with subjects treated with active.
10963893|NCT00874770|OG002|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11234723|NCT02436876|OG000|Outcome|MBN-101 0.5 µg/cm2|Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
11234724|NCT02436876|OG001|Outcome|MBN-101 1.5 µg/cm2|Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
11234725|NCT02436876|OG002|Outcome|MBN-101 5.0 µg/cm2|Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
11234726|NCT02436876|OG003|Outcome|Placebo|The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo was randomized 1:3 with active drug product treatment Cohorts 1-3
11234727|NCT02436876|OG000|Outcome|Cohort 1|"Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234728|NCT02436876|OG001|Outcome|Cohort 2|"Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234729|NCT02436876|OG002|Outcome|Cohort 3|"Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234730|NCT02436876|OG003|Outcome|Placebo|Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. The placebo was randomized 1:3 with active drug product in Cohorts 1-3.
11234731|NCT02436876|OG003|Outcome|Placebo|The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo was randomized 1:3 with active drug product in Cohorts 1-3.
11234732|NCT02436876|EG000|Reported Event|MBN-101 0.5 µg/cm2|"Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234733|NCT02436876|EG001|Reported Event|MBN-101 1.5 µg/cm2|"Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234734|NCT02436876|EG002|Reported Event|MBN-101 5.0 µg/cm2|"Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo~MBN-101: MBN-101 is a locally administered, anti-infective drug product"
11234735|NCT02436876|EG003|Reported Event|Placebo|Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo subjects were randomized 1:3 with subjects treated with active drug product in Cohorts 1-3.
11234736|NCT02436889|BG000|Baseline|Mirabegron|"Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with Mirabegron (25mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day (Mirabegron 50mg).~Mirabegron"
11234737|NCT02436889|BG001|Baseline|Tolterodine Tartrate|"Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with tolterodine tartrate (4 mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day tolterodine tartrate 4 mg + identical placebo.~Tolterodine Tartrate"
11234738|NCT02436889|BG002|Baseline|Total|Total of all reporting groups
11234739|NCT02436889|FG000|Participant Flow|Mirabegron|"Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with Mirabegron (25mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day (Mirabegron 50mg).~Mirabegron"
11234740|NCT02436889|FG001|Participant Flow|Tolterodine Tartrate|"Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with tolterodine tartrate (4 mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day tolterodine tartrate 4 mg + identical placebo.~Tolterodine Tartrate"
11234741|NCT02436889|OG000|Outcome|Mirabegron|"Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with Mirabegron (25mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day (Mirabegron 50mg).~Mirabegron"
11234742|NCT02436889|OG001|Outcome|Tolterodine Tartrate|"Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with tolterodine tartrate (4 mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day tolterodine tartrate 4 mg + identical placebo.~Tolterodine Tartrate"
11234743|NCT02436889|EG000|Reported Event|Mirabegron|"Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with Mirabegron (25mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day (Mirabegron 50mg).~Mirabegron"
11234744|NCT02436889|EG001|Reported Event|Tolterodine Tartrate|"Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with tolterodine tartrate (4 mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day tolterodine tartrate 4 mg + identical placebo.~Tolterodine Tartrate"
11234745|NCT02436915|BG000|Baseline|Real tDCS|"The real tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.~Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability."
11234746|NCT02436915|BG001|Baseline|Sham tDCS|"The sham tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.~Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation."
11234747|NCT02436915|BG002|Baseline|Total|Total of all reporting groups
11234748|NCT02436915|FG000|Participant Flow|Real tDCS|"The real tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.~Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability."
11234749|NCT02436915|FG001|Participant Flow|Sham tDCS|"The sham tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.~Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation."
11234750|NCT02436915|OG000|Outcome|Real tDCS|"The real tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.~Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability."
11234751|NCT02436915|OG001|Outcome|Sham tDCS|"The sham tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.~Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation."
11234752|NCT02436915|OG000|Outcome|Real tDCS|"The real tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) targeting left prefrontal cortex at a target current intensity of 1.5 mA.~Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability."
11234753|NCT02436915|OG001|Outcome|Sham tDCS|"The sham tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation with same montage as the real tDCS, except current will only be applied for the first 60 seconds of each session.~Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation."
11234754|NCT02436915|EG000|Reported Event|Real tDCS|"The real tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.~Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability."
11234755|NCT02436915|EG001|Reported Event|Sham tDCS|"The sham tDCS intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.~Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation."
11234756|NCT02437084|BG000|Baseline|Individuals Without Diabetes Eligible to Receive Statin Therapy|"Eligible participants will receive 40 mg of atorvastatin~Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks."
10961753|NCT00862849|FG001|Participant Flow|Lispro+rHuPH20 First, Then Lispro Alone, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone~Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
11234757|NCT02437084|FG000|Participant Flow|Atorvastatin Treatment|Participants received treatment with atorvastatin 40 mg daily for 10 weeks.
11234758|NCT02437084|OG000|Outcome|Individuals Without Diabetes Eligible to Receive Statin Therapy|"Eligible participants will receive 40 mg of atorvastatin~Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks."
11234759|NCT02437084|EG000|Reported Event|Individuals Without Diabetes Eligible to Receive Statin Therapy|"Eligible participants will receive 40 mg of atorvastatin~Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks."
11234760|NCT02437162|BG000|Baseline|Placebo|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
11234761|NCT02437162|BG001|Baseline|Ustekinumab 45 mg|Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
11234762|NCT02437162|BG002|Baseline|Ustekinumab 90 mg|Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
11234763|NCT02437162|BG003|Baseline|Total|Total of all reporting groups
11234764|NCT02437162|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
11234765|NCT02437162|FG001|Participant Flow|Ustekinumab 45 mg|Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
11234766|NCT02437162|FG002|Participant Flow|Ustekinumab 90 mg|Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
11234767|NCT02437162|OG000|Outcome|Placebo|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
11234768|NCT02437162|OG001|Outcome|Ustekinumab 45 Milligram (mg)|Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
11234769|NCT02437162|OG002|Outcome|Ustekinumab 90 mg|Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
11234770|NCT02437162|EG000|Reported Event|Placebo Only|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
11234771|NCT02437162|EG001|Reported Event|Placebo to Golimumab|Participants randomized to placebo SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.
11234772|NCT02437162|EG002|Reported Event|Placebo to Ustekinumab 45mg|Participants randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward.
10961754|NCT00862849|FG002|Participant Flow|RHI+rHuPH20 First, Then Lispro+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
11234773|NCT02437162|EG003|Reported Event|Placebo to Ustekinumab 90mg|Participants randomized to placebo SC and then rerandomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward.
11234774|NCT02437162|EG004|Reported Event|Ustekinumab 45 mg Only|Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.
11234775|NCT02437162|EG005|Reported Event|Ustekinumab 45mg to Golimumab|Participants randomized to ustekinumab 45 mg SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.
11234776|NCT02437162|EG006|Reported Event|Ustekinumab 90 mg Only|Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.
11234777|NCT02437162|EG007|Reported Event|Ustekinumab 90mg to Golimumab|Participants randomized to ustekinumab 90 mg SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.
11234778|NCT02437188|BG000|Baseline|ACT + TAU|Acceptance and Commitment Therapy plus Treatment as Usual
11234779|NCT02437188|BG001|Baseline|Treatment as Usual|Treatment as usual - preoperative education and perioperative analgesia
11234780|NCT02437188|BG002|Baseline|Total|Total of all reporting groups
11234781|NCT02437188|FG000|Participant Flow|ACT + TAU|Acceptance and Commitment Therapy plus Treatment as Usual
11234782|NCT02437188|FG001|Participant Flow|Treatment as Usual (TAU)|Treatment as Usual
11234783|NCT02437188|OG000|Outcome|ACT + TAU|Acceptance and Commitment Therapy plus treatment as usual
11234784|NCT02437188|OG001|Outcome|Treatment as Usual (TAU)|Treatment as Usual
11234785|NCT02437188|OG001|Outcome|Treatment as Usual|Treatment as usual - preoperative education and perioperative analgesia
11234786|NCT02437188|OG001|Outcome|Treatment as Usual|Treatment as usual - preoperative education and peri-operative analgesia
11234787|NCT02437188|OG000|Outcome|ACT + TAU|Acceptance and Commitment Therapy plus Treatment as Usual
11234788|NCT02437188|EG000|Reported Event|ACT + TAU|
11234789|NCT02437188|EG001|Reported Event|Treatment as Usual|
11234790|NCT02437253|BG000|Baseline|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks.
11234791|NCT02437253|BG001|Baseline|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
11234792|NCT02437253|BG002|Baseline|Total|Total of all reporting groups
11234793|NCT02437253|FG000|Participant Flow|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week.
11234794|NCT02437253|FG001|Participant Flow|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
11234795|NCT02437253|OG000|Outcome|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks.
11234796|NCT02437253|OG001|Outcome|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
11234797|NCT02437253|OG001|Outcome|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
11234798|NCT02437253|OG000|Outcome|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week.
11234799|NCT02437253|EG000|Reported Event|Adalimumab|"20 mg subQ every other week (weight 15 to <30 kg) 40 mg subQ every other week (weight ≥30 kg).~Adalimumab: Subjects will be treated with adalimumab (20 mg [weight 15-<30 kg] or 40 mg [weight ≥30 kg] administered subcutaneously [subQ] every other week) or placebo for 16 weeks, then cross-over to the other group for 16 weeks."
11234800|NCT02437253|EG001|Reported Event|Placebo|"Saline placebo injection~Placebo: Saline placebo"
11234801|NCT02437305|BG000|Baseline|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
11234802|NCT02437305|BG001|Baseline|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
11234803|NCT02437305|BG002|Baseline|Total|Total of all reporting groups
11234804|NCT02437305|FG000|Participant Flow|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
11234805|NCT02437305|FG001|Participant Flow|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
11234806|NCT02437305|OG000|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
11234807|NCT02437305|OG001|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
11234808|NCT02437305|EG000|Reported Event|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
11234809|NCT02437305|EG001|Reported Event|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
11234810|NCT02437344|BG000|Baseline|CI-581aa|"CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing~CI-581aa: 92 minute infusion of CI-581aa~Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX"
11234811|NCT02437344|FG000|Participant Flow|CI-581aa|"CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing~CI-581aa: 92 minute infusion of CI-581aa~Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX"
11234812|NCT02437344|OG000|Outcome|CI-581aa|"CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing~CI-581aa: 92 minute infusion of CI-581aa~Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX"
11234813|NCT02437344|EG000|Reported Event|CI-581aa|"CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing~CI-581aa: 92 minute infusion of CI-581aa~Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX"
11234814|NCT02437383|BG000|Baseline|Propranolol ER|"Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).~Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4."
11234815|NCT02437383|BG001|Baseline|Placebo|"Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).~Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules"
11234816|NCT02437383|BG002|Baseline|Total|Total of all reporting groups
11234817|NCT02437383|FG000|Participant Flow|Propranolol ER|"Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).~Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4."
11234818|NCT02437383|FG001|Participant Flow|Placebo|"Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).~Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules"
11234819|NCT02437383|OG000|Outcome|Propranolol ER|"Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).~Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4."
11234820|NCT02437383|OG001|Outcome|Placebo|"Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).~Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules"
10961755|NCT00862849|FG003|Participant Flow|RHI+rHuPH20 First, Then Lispro Alone, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
11234821|NCT02437383|EG000|Reported Event|Propranolol ER|"Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).~Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4."
11234822|NCT02437383|EG001|Reported Event|Placebo|"Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).~Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules"
11234823|NCT02437409|BG000|Baseline|All Patients|Treated with pREset Thrombectomy Retriever
11234824|NCT02437409|FG000|Participant Flow|All Patients|Treated with pREset Thrombectomy Retriever
11234825|NCT02437409|OG000|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
11234826|NCT02437409|OG000|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
11234827|NCT02437409|EG000|Reported Event|All Patients|Treated with pREset Thrombectomy Retriever
11234828|NCT02437487|BG000|Baseline|SER-109|"SER 109 (1 × 108 SporQs)~SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors."
11234829|NCT02437487|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline."
11234830|NCT02437487|BG002|Baseline|Total|Total of all reporting groups
11234831|NCT02437487|FG000|Participant Flow|SER-109|"SER 109 (1 × 108 SporQs)~SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors."
11234832|NCT02437487|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline."
11234833|NCT02437487|OG000|Outcome|SER-109|"SER 109 (1 × 108 SporQs)~SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors."
11234834|NCT02437487|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline."
11234835|NCT02437487|EG000|Reported Event|SER-109|"SER 109 (1 × 108 SporQs)~SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors."
11234836|NCT02437487|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline."
11234837|NCT02437513|BG000|Baseline|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
11234838|NCT02437513|FG000|Participant Flow|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
11234839|NCT02437513|OG000|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
11234840|NCT02437513|EG000|Reported Event|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
11234841|NCT02437669|BG000|Baseline|Intranasal Hydromorphone|Children who received intranasal hydromorphone
11234842|NCT02437669|FG000|Participant Flow|Intranasal Hydromorphone|"Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg.~Hydromorphone: To be administered by intranasal route using mucosal atomization device."
11234843|NCT02437669|OG000|Outcome|Intranasal Hydromorphone|"Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg.~Hydromorphone: To be administered by intranasal route using mucosal atomization device."
10961756|NCT00862849|FG004|Participant Flow|Lispro Alone First, Then Lispro+rHuPH20, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
11234844|NCT02437669|OG000|Outcome|Intranasal Hydromorphone|Children who received intranasal hydromorphone
11234845|NCT02437669|EG000|Reported Event|Intranasal Hydromorphone|Children who received intranasal hydromorphone
11234846|NCT02437864|BG000|Baseline|Baseline Group|Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
11234847|NCT02437864|BG001|Baseline|With-Cannula Group|"Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.~Supplemental oxygen via nasal cannula"
11234848|NCT02437864|BG002|Baseline|Total|Total of all reporting groups
11234849|NCT02437864|FG000|Participant Flow|Baseline Group|Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
11234850|NCT02437864|FG001|Participant Flow|With-Cannula Group|"Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.~Supplemental oxygen via nasal cannula"
11234851|NCT02437864|OG000|Outcome|Baseline Group|Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
11234852|NCT02437864|OG001|Outcome|With-Cannula Group|"Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.~Supplemental oxygen via nasal cannula"
11234853|NCT02437864|EG000|Reported Event|Baseline Group|Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
11234854|NCT02437864|EG001|Reported Event|With-Cannula Group|"Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.~Supplemental oxygen via nasal cannula"
11234855|NCT02437890|BG000|Baseline|Placebo|Two s.c. injections with placebo every 2 weeks (q2w)
11234856|NCT02437890|BG001|Baseline|ALX-0061 75 mg q4w|ALX-0061 75 mg every 4 weeks (q4w)
11234857|NCT02437890|BG002|Baseline|ALX-0061 150 mg q4w|ALX-0061 150 mg every 4 weeks (q4w)
11234858|NCT02437890|BG003|Baseline|ALX-0061 150 mg q2w|ALX-0061 150 mg every two weeks (q2w)
11234859|NCT02437890|BG004|Baseline|ALX-0061 225 mg q2w|ALX-0061 225 mg every two weeks (q2w)
11234860|NCT02437890|BG005|Baseline|Total|Total of all reporting groups
11234861|NCT02437890|FG000|Participant Flow|Placebo|"Two s.c. injections with placebo every 2 weeks (q2w).~***~Placebo was supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to the placebo group received 2 s.c. injections q2w:~Syringe A with placebo (1 mL) q2w starting at Day 1, up to and including Week 46.~Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46."
11234862|NCT02437890|FG001|Participant Flow|ALX-0061 75 mg q4w|"ALX-0061 75 mg every 4 weeks (q4w).~***~Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 75 mg q4w received 2 s.c. injections q2w:~Syringe A with placebo (1 mL) q2w starting at Day 1, up to and including Week 46.~Syringe B with ALX-0061 (0.5 mL) q4w at Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44, and syringe B with placebo (0.5 mL) q4w at Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, and 46."
11234863|NCT02437890|FG002|Participant Flow|ALX-0061 150 mg q4w|"ALX-0061 150 mg every 4 weeks (q4w).~***~Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 150 mg q4w received 2 s.c. injections q2w:~Syringe A with ALX-0061 (1 mL) q4w at Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44, and syringe A with placebo (1 mL) q4w at Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, and 46.~Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46."
11234864|NCT02437890|FG003|Participant Flow|ALX-0061 150 mg q2w|"ALX-0061 150 mg every 2 weeks (q2w).~***~Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 150 mg q2w received 2 s.c. injections q2w:~Syringe A with ALX-0061 (1 mL) q2w starting at Day 1, up to and including Week 46.~Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46."
11234865|NCT02437890|FG004|Participant Flow|ALX-0061 225 mg q2w|"ALX-0061 225 mg every 2 weeks (q2w).~***~Vobarilizumab (ALX-0061) was supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 225 mg q2w received 2 s.c. injections q2w:~Syringe A with ALX-0061 (1 mL) q2w starting at Day 1, up to and including Week 46.~Syringe B with ALX-0061 (0.5 mL) q2w starting at Day 1, up to and including Week 46."
11234866|NCT02437890|OG000|Outcome|Placebo|Two s.c. injections with placebo every 2 weeks (q2w)
11234867|NCT02437890|OG001|Outcome|ALX-0061 75 mg q4w|ALX-0061 75 mg every 4 weeks (q4w)
11234868|NCT02437890|OG002|Outcome|ALX-0061 150 mg q4w|ALX-0061 150 mg every 4 weeks (q4w)
11234869|NCT02437890|OG003|Outcome|ALX-0061 150 mg q2w|ALX-0061 150 mg every 2 weeks (q2w)
11234870|NCT02437890|OG004|Outcome|ALX-0061 225 mg q2w|ALX-0061 225 mg every 2 weeks (q2w)
11234871|NCT02437890|OG000|Outcome|ALX-0061 75 mg 4qw|ALX-0061 75 mg every 4 weeks (q4w)
11234872|NCT02437890|OG001|Outcome|ALX-0061 150 mg q4w|ALX-0061 150 mg every 4 weeks (q4w)
11234873|NCT02437890|OG002|Outcome|ALX-0061 150 mg q2w|ALX-0061 150 mg every 2 weeks (q2w)
11234874|NCT02437890|OG003|Outcome|ALX-0061 225 mg q2w|ALX-0061 225 mg every 2 weeks (q2w)
11234875|NCT02437890|EG000|Reported Event|Placebo|Two s.c. injections with placebo every 2 weeks (q2w)
11234876|NCT02437890|EG001|Reported Event|ALX-0061 75 mg q4w|ALX-0061 75 mg every 4 weeks (q4w)
11234877|NCT02437890|EG002|Reported Event|ALX-0061 150 mg q4w|ALX-0061 150 mg every 4 weeks (q4w)
11234878|NCT02437890|EG003|Reported Event|ALX-0061 150 mg q2w|ALX-0061 150 mg every 2 weeks (q2w)
11234879|NCT02437890|EG004|Reported Event|ALX-0061 225 mg q2w|ALX-0061 225 mg every 2 weeks (q2w)
11234880|NCT02437903|BG000|Baseline|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
11234881|NCT02437903|FG000|Participant Flow|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
11234882|NCT02437903|OG000|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12"
11234883|NCT02437903|OG000|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
11234884|NCT02437903|EG000|Reported Event|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
11234885|NCT02438137|BG000|Baseline|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
11234886|NCT02438137|BG001|Baseline|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
11234887|NCT02438137|BG002|Baseline|Total|Total of all reporting groups
11234888|NCT02438137|FG000|Participant Flow|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
11234889|NCT02438137|FG001|Participant Flow|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
11234890|NCT02438137|OG000|Outcome|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
11234891|NCT02438137|OG001|Outcome|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo will be instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
11234892|NCT02438137|OG000|Outcome|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day, though slower dose escalations were possible to increase tolerability, if necessary. Subjects randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance was reconciled at follow-up visits, and recorded in accountability logs. Subjects were instructed to take medication with food, (morning and at dinnertime). If subjects missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
11234893|NCT02438137|OG001|Outcome|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Subjects randomized to placebo will be instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Subjects were instructed to take the placebo with food, in the morning and at dinnertime. If subjects missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
11234894|NCT02438137|EG000|Reported Event|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
11234895|NCT02438137|EG001|Reported Event|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
11234896|NCT02438280|BG000|Baseline|A (Active Device)|"20 minutes daily usage in conjunction with orthodontic treatment with clear aligners~AcceleDent, Vibrational Device: Participants will receive one of two vibrational units"
11234897|NCT02438280|BG001|Baseline|B (Control Device)|"20 minutes daily usage in conjunction with orthodontic treatment with clear aligners~AcceleDent, Vibrational Device: Participants will receive one of two vibrational units"
11234898|NCT02438280|BG002|Baseline|Total|Total of all reporting groups
11234899|NCT02438280|FG000|Participant Flow|A (Active Device)|"20 minutes daily usage in conjunction with orthodontic treatment with clear aligners~AcceleDent, Vibrational Device: Participants will receive one of two vibrational units~This groups received Active Devices with frequency of 30Hz ( revealed after study completion )"
11234900|NCT02438280|FG001|Participant Flow|B (Control Device)|"20 minutes daily usage in conjunction with orthodontic treatment with clear aligners~AcceleDent, Vibrational Device: Participants will receive one of two vibrational units~This group received control devices with frequency of 0 Hz ( revealed after study completion )"
11234901|NCT02438280|OG000|Outcome|A (Active Device)|20 minutes daily usage of an active vibration device
11234902|NCT02438280|OG001|Outcome|B (Control Device)|20 minutes daily usage of a placebo vibration device
10961757|NCT00862849|FG005|Participant Flow|Lispro Alone First, Then RHI+rHuPH20, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone~Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
10961758|NCT00862849|OG000|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
10961759|NCT00862849|OG001|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
11234903|NCT02438280|OG000|Outcome|A (Active Device)|20 minutes daily usage of a vibration device
11234904|NCT02438280|EG000|Reported Event|A (Active Device)|"20 minutes daily usage in conjunction with orthodontic treatment with clear aligners~AcceleDent, Vibrational Device: Participants will receive one of two vibrational units"
11234905|NCT02438280|EG001|Reported Event|B (Control Device)|"20 minutes daily usage in conjunction with orthodontic treatment with clear aligners~AcceleDent, Vibrational Device: Participants will receive one of two vibrational units"
11234906|NCT02438371|BG000|Baseline|Nifedipine|Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
11234907|NCT02438371|BG001|Baseline|Nifedipine Plus Indomethacin|Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
11234908|NCT02438371|BG002|Baseline|Total|Total of all reporting groups
11234909|NCT02438371|FG000|Participant Flow|Nifedipine|Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
11234910|NCT02438371|FG001|Participant Flow|Nifedipine Plus Indomethacin|Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
11234911|NCT02438371|OG000|Outcome|Nifedipine|Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
11234912|NCT02438371|OG001|Outcome|Nifedipine Plus Indomethacin|Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
11234913|NCT02438371|EG000|Reported Event|Nifedipine|Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
11234914|NCT02438371|EG001|Reported Event|Nifedipine Plus Indomethacin|Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
11234915|NCT02438384|BG000|Baseline|Usual Care|Pts will receive education and follow-up based on judgment of emergency provider.
11234916|NCT02438384|BG001|Baseline|Video|"Patients will watch 10 minute educational video~Video: This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids."
10961760|NCT00862849|OG002|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
10961761|NCT00862849|EG000|Reported Event|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
10961762|NCT00862849|EG001|Reported Event|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
10961763|NCT00862849|EG002|Reported Event|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
11234917|NCT02438384|BG002|Baseline|Video Plus Phone Follow-up|"Patients will watch 10 minute educational video and receive phone call follow-up at 3 days to assess pain symptoms. Patients with a pain score of 4 or more will receive another call with advice from a geriatric pain specialist.~Video: This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids.~Phone follow-up: The call will be made by the study coordinator, who is a medical student. Any patients reporting a pain score in the past 24 hours of 4 or more will be re-contacted by an emergency physician with special training in geriatric pain management. This individual will provide recommendations to the patient regarding treatment options."
11234918|NCT02438384|BG003|Baseline|Total|Total of all reporting groups
11234919|NCT02438384|FG000|Participant Flow|Usual Care|Pts will receive education and follow-up based on judgment of emergency provider.
11234920|NCT02438384|FG001|Participant Flow|Video|"Patients will watch 10 minute educational video~Video: This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids."
11234921|NCT02438384|FG002|Participant Flow|Video Plus Phone Follow-up|"Patients will watch 10 minute educational video and receive phone call follow-up at 3 days to assess pain symptoms. Patients with a pain score of 4 or more will receive another call with advice from a geriatric pain specialist.~Video: This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids.~Phone follow-up: The call will be made by the study coordinator, who is a medical student. Any patients reporting a pain score in the past 24 hours of 4 or more will be re-contacted by an emergency physician with special training in geriatric pain management. This individual will provide recommendations to the patient regarding treatment options."
10961764|NCT00862940|BG000|Baseline|Memantine 10 mg Tablets Twice Daily|
11234922|NCT02438384|OG000|Outcome|Usual Care|Pts will receive education and follow-up based on judgment of emergency provider.
11234923|NCT02438384|OG001|Outcome|Video|"Patients will watch 10 minute educational video~Video: This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids."
11234924|NCT02438384|OG002|Outcome|Video Plus Phone Follow-up|"Patients will watch 10 minute educational video and receive phone call follow-up at 3 days to assess pain symptoms. Patients with a pain score of 4 or more will receive another call with advice from a geriatric pain specialist.~Video: This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids.~Phone follow-up: The call will be made by the study coordinator, who is a medical student. Any patients reporting a pain score in the past 24 hours of 4 or more will be re-contacted by an emergency physician with special training in geriatric pain management. This individual will provide recommendations to the patient regarding treatment options."
11234925|NCT02438384|EG000|Reported Event|Usual Care|Pts will receive education and follow-up based on judgment of emergency provider.
11234926|NCT02438384|EG001|Reported Event|Video|"Patients will watch 10 minute educational video~Video: This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids."
11234927|NCT02438384|EG002|Reported Event|Video Plus Phone Follow-up|"Patients will watch 10 minute educational video and receive phone call follow-up at 3 days to assess pain symptoms. Patients with a pain score of 4 or more will receive another call with advice from a geriatric pain specialist.~Video: This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids.~Phone follow-up: The call will be made by the study coordinator, who is a medical student. Any patients reporting a pain score in the past 24 hours of 4 or more will be re-contacted by an emergency physician with special training in geriatric pain management. This individual will provide recommendations to the patient regarding treatment options."
11234928|NCT02438423|BG000|Baseline|IIV Delivered by MN Patch by Study Staff|"Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234929|NCT02438423|BG001|Baseline|IIV Delivered IM by Study Staff|"Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
10961765|NCT00862940|BG001|Baseline|Placebo Tablets Twice Daily|
11234930|NCT02438423|BG002|Baseline|IIV Delivered by MN Patch by Subject|"Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
10847249|NCT00282347|FG001|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10847250|NCT00282347|OG000|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10847251|NCT00282347|OG001|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10847252|NCT00282347|EG000|Reported Event|Rituximab - Treatment and Safety Follow-up Periods|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10847253|NCT00282347|EG001|Reported Event|Placebo - Treatment and Safety Follow-up Periods|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10847254|NCT00282347|EG002|Reported Event|Rituximab - B Cell Follow-up Period|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
10847255|NCT00282347|EG003|Reported Event|Placebo - B Cell Follow-up Period|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
11234931|NCT02438423|BG003|Baseline|Placebo MN Patch by Study Staff|"Placebo delivered by microneedle patch administered by study staff~Placebo"
11234932|NCT02438423|BG004|Baseline|Total|Total of all reporting groups
11234933|NCT02438423|FG000|Participant Flow|IIV Delivered by MN Patch by Study Staff|"Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234934|NCT02438423|FG001|Participant Flow|IIV Delivered IM by Study Staff|"Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234935|NCT02438423|FG002|Participant Flow|IIV Delivered by MN Patch by Subject|"Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234936|NCT02438423|FG003|Participant Flow|Placebo MN Patch by Study Staff|"Placebo delivered by microneedle patch administered by study staff~Placebo"
11234937|NCT02438423|OG000|Outcome|IIV Delivered by MN Patch by Study Staff|"Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234938|NCT02438423|OG001|Outcome|IIV Delivered IM by Study Staff|"Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234939|NCT02438423|OG002|Outcome|IIV Delivered by MN Patch by Subject|"Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
10961766|NCT00862940|BG002|Baseline|Total|Total of all reporting groups
11234940|NCT02438423|OG003|Outcome|Placebo MN Patch by Study Staff|"Placebo delivered by microneedle patch administered by study staff~Placebo"
11234941|NCT02438423|OG000|Outcome|IIV Delivered by MN Patch by Study Staff|Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
11234942|NCT02438423|OG001|Outcome|IIV Delivered IM by Study Staff|Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
11234943|NCT02438423|EG000|Reported Event|IIV Delivered by MN Patch by Study Staff|"Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234944|NCT02438423|EG001|Reported Event|IIV Delivered IM by Study Staff|"Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234945|NCT02438423|EG002|Reported Event|IIV Delivered by MN Patch by Subject|"Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject~Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season"
11234946|NCT02438423|EG003|Reported Event|Placebo MN Patch by Study Staff|"Placebo delivered by microneedle patch administered by study staff~Placebo"
11234947|NCT02438475|BG000|Baseline|Mynx Vascular Closure System|"Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone~Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath."
11234948|NCT02438475|BG001|Baseline|Manual Compression|"Where patients will have venous hemostasis attempted to be achieved using manual compression alone~Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes"
11234949|NCT02438475|BG002|Baseline|Total|Total of all reporting groups
11234950|NCT02438475|FG000|Participant Flow|Mynx Vascular Closure System|"Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone~Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath."
11234951|NCT02438475|FG001|Participant Flow|Manual Compression|"Where patients will have venous hemostasis attempted to be achieved using manual compression alone~Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes"
11234952|NCT02438475|OG000|Outcome|Mynx Vascular Closure System|"Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone~Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath."
11234953|NCT02438475|OG001|Outcome|Manual Compression|"Where patients will have venous hemostasis attempted to be achieved using manual compression alone~Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes"
11234954|NCT02438475|EG000|Reported Event|Mynx Vascular Closure System|"Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone~Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath."
11234955|NCT02438475|EG001|Reported Event|Manual Compression|"Where patients will have venous hemostasis attempted to be achieved using manual compression alone~Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes"
10961767|NCT00862940|FG000|Participant Flow|Memantine 10 mg Tablets Twice Daily|
10961768|NCT00862940|FG001|Participant Flow|Placebo Tablets Twice Daily|
10961769|NCT00862940|OG000|Outcome|Memantine 10 mg Tablets Twice Daily|
10961770|NCT00862940|OG001|Outcome|Placebo Tablets Twice Daily|
10961771|NCT00862940|EG000|Reported Event|Memantine 10 mg Tablets Twice Daily|
11180449|NCT02061813|BG000|Baseline|All Randomized Subjects|All Randomized Subjects included all subjects who were enrolled into the study. All subjects had the investigational product (abametapir lotion), the vehicle product, the positive control patch, and negative control patch applied to 4 randomly assigned, adjacent skin sites on the infrascapular area of their back, for the purpose of determining irritation potential.
11180450|NCT02061813|FG000|Participant Flow|All Randomized Subjects|All Randomized Subjects included all subjects who were enrolled into the study. All subjects had the investigational product (abametapir lotion), the vehicle product, the positive control patch, and negative control patch applied to 4 randomly assigned, adjacent skin sites on the infrascapular area of their back, for the purpose of determining irritation potential.
11180451|NCT02061813|OG000|Outcome|Abametapir Lotion Group|All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design
11180452|NCT02061813|OG001|Outcome|Vehicle Lotion|All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design
11180453|NCT02061813|OG002|Outcome|Saline 0.9%|All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design
11180454|NCT02061813|OG003|Outcome|Sodium Lauryl Sulphate (SLS)|All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design
11180455|NCT02061813|EG000|Reported Event|All Randomized Subjects|All Randomized Subjects included all subjects who were enrolled into the study. All subjects received application of all four interventions.
11180456|NCT02061969|BG000|Baseline|Insulin Glargine|"Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.~Insulin glargine."
11180457|NCT02061969|BG001|Baseline|Linagliptin|"Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.~linagliptin: 5mg linagliptin tablets."
11180458|NCT02061969|BG002|Baseline|Total|Total of all reporting groups
10961772|NCT00862940|EG001|Reported Event|Placebo Tablets Twice Daily|
11180459|NCT02061969|FG000|Participant Flow|Insulin Glargine|"Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.~Insulin glargine"
11180460|NCT02061969|FG001|Participant Flow|Linagliptin|"Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.~linagliptin: 5mg linagliptin tablets"
11180461|NCT02061969|OG000|Outcome|Insulin Glargine|"Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.~Insulin glargine"
11180462|NCT02061969|OG001|Outcome|Linagliptin|"Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.~linagliptin: 5mg linagliptin tablets"
11180463|NCT02061969|EG000|Reported Event|Insulin Glargine|"Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.~Insulin glargine"
11180464|NCT02061969|EG001|Reported Event|Linagliptin|"Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.~linagliptin: 5mg linagliptin tablets"
11180465|NCT02062008|BG000|Baseline|Cardiac Patients Receiving PET/MR|"PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.~PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour."
11180466|NCT02062008|FG000|Participant Flow|Cardiac Patients Receiving PET/MR|"PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.~PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour."
11180467|NCT02062008|OG000|Outcome|Cardiac Patients Receiving PET/MR|"PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.~PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour."
11180468|NCT02062008|EG000|Reported Event|Cardiac Patients Receiving PET/MR|"PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.~PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour."
11180469|NCT02062151|BG000|Baseline|NAS Babies|"Acupuncture for NAS~Acupuncture: Acupuncture"
11180470|NCT02062151|FG000|Participant Flow|NAS Babies|"Acupuncture for NAS~Acupuncture: Acupuncture"
11180471|NCT02062151|OG000|Outcome|NAS Babies|"Acupuncture for NAS~Acupuncture: Acupuncture"
11180472|NCT02062151|EG000|Reported Event|NAS Babies|"Acupuncture for NAS~Acupuncture"
11180473|NCT02062177|BG000|Baseline|Propofol Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient's body weight and general condition.~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.~Patients in this group received placebo boluses with normal saline to warrant blindness to the randomization group of both patient and endoscopist. (because of the well-known difference in the physical appearance of the study drugs, to maintain blindness of endoscopist, a fabric curtain was drawn across patient's arm covering the i.v. line and TCI pump)."
11180474|NCT02062177|BG001|Baseline|Midazolam Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
11180475|NCT02062177|BG002|Baseline|Total|Total of all reporting groups
11180476|NCT02062177|FG000|Participant Flow|Propofol Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient's body weight and general condition.~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
11180477|NCT02062177|FG001|Participant Flow|Midazolam Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
11180478|NCT02062177|OG000|Outcome|Propofol Group; n=35, 35|
11180479|NCT02062177|OG001|Outcome|Midazolam Group; n=35, 35|
11180480|NCT02062177|EG000|Reported Event|Propofol Group; n=35, 35|35 upper endoscopy 35 colonoscopy
11180481|NCT02062177|EG001|Reported Event|Midazolam Group; n=35, 35|35 upper endoscopy 35 colonoscopy
11180482|NCT02062294|BG000|Baseline|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
11180483|NCT02062294|FG000|Participant Flow|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
11180484|NCT02062294|OG000|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
10961773|NCT00862979|BG000|Baseline|CNI-regimen|CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
11180485|NCT02062294|EG000|Reported Event|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
11180486|NCT02062359|BG000|Baseline|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
11180487|NCT02062359|FG000|Participant Flow|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
11180488|NCT02062359|OG000|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
11180489|NCT02062359|EG000|Reported Event|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
11180490|NCT02062385|BG000|Baseline|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
11180491|NCT02062385|BG001|Baseline|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
11180492|NCT02062385|BG002|Baseline|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180493|NCT02062385|BG003|Baseline|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180494|NCT02062385|BG004|Baseline|Total|Total of all reporting groups
11180495|NCT02062385|FG000|Participant Flow|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
11180496|NCT02062385|FG001|Participant Flow|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
11180497|NCT02062385|FG002|Participant Flow|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180498|NCT02062385|FG003|Participant Flow|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180499|NCT02062385|OG000|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180500|NCT02062385|OG001|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180501|NCT02062385|OG000|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180502|NCT02062385|OG001|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180503|NCT02062385|EG000|Reported Event|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180504|NCT02062385|EG001|Reported Event|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
11180505|NCT02062398|BG000|Baseline|The Reprieve System Implantation|"The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.~The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain"
11180506|NCT02062398|FG000|Participant Flow|The Reprieve System Implantation|"The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.~The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain"
11180507|NCT02062398|OG000|Outcome|The Reprieve System Implantation|"The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.~The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain"
11180508|NCT02062398|EG000|Reported Event|The Reprieve System Implantation|"The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.~The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain"
11180509|NCT02062437|BG000|Baseline|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
11180510|NCT02062437|FG000|Participant Flow|Total Hip Replacement Using a Ceramic Friction Pair|All patients were treated with a total hip replacement using a ceramic friction pair Biolox® delta, with a Meije Duo® cementless stem with HAP associated with a cementless double coating of plasma sprayed titanium and HAP Dynacup® acetabular cup.
11180511|NCT02062437|OG000|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
11180512|NCT02062437|EG000|Reported Event|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
11180513|NCT02062450|BG000|Baseline|Primary Surgery|Patients who underwent a primary hip replacement surgery with Dual Mobility Cup
11180514|NCT02062450|BG001|Baseline|Revision Surgery|Patients who underwent a revision hip replacement surgery with Dual Mobility Cup
11180515|NCT02062450|BG002|Baseline|Total|Total of all reporting groups
11180516|NCT02062450|FG000|Participant Flow|Hip Acetabular Replacement, Using a Dual Mobility Cup.|"Studied cohort includes 2 subgroups :~Patients with primary hip replacement.~Patients with revision surgery."
11180517|NCT02062450|OG000|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
11234956|NCT02438540|BG000|Baseline|Metformin & Acupuncture|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
11234957|NCT02438540|BG001|Baseline|Metformin & Placebo|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and placebo ( for acupuncture treatment including electro body acupuncture and Auricular acupuncture), needling not in right acupoints (for those points that were located in the abdomen, needles were inserted 0.3 cm laterally from the real location and the needling was maximally superficial. Those points that were located on other parts of the body, needles were inserted 0.5 cm up and 0.5 cm laterally from the real location and needling was superficial as well. Electric lines were connected with some of the needles same way they were connected in another case group. EA machine was switched off during 30 minutes of therapeutic time. Ear acupuncture was used on the same location as in the case group however we just used sticky layers without seeds), for 30 minutes, 10 times, every other day, for 3 weeks.~metformin Placebo (for acupuncture including electro"
11234958|NCT02438540|BG002|Baseline|Total|Total of all reporting groups
11234959|NCT02438540|FG000|Participant Flow|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
11234960|NCT02438540|FG001|Participant Flow|Metformin & Placebo|Metformin 500 mg (one/two/three times per day) to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and electro acupuncture (EA) machine was switched off during 30 minutes of therapeutic time. And ear acupuncture was just used sticky layers without seeds. All placebo treatments used for 30 minutes, 10 times, every other day, for 3 weeks.
11234961|NCT02438540|OG000|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
11234962|NCT02438540|OG001|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
11234963|NCT02438540|OG001|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo EA and auricular acupuncture"
11234964|NCT02438540|EG000|Reported Event|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
11234965|NCT02438540|EG001|Reported Event|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
11234966|NCT02438787|BG000|Baseline|Placebo|Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
11234967|NCT02438787|BG001|Baseline|Ustekinumab 45mg|Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
11234968|NCT02438787|BG002|Baseline|Ustekinumab 90mg|Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
11234969|NCT02438787|BG003|Baseline|Total|Total of all reporting groups
11234970|NCT02438787|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met early escape (EE) criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 Weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
10961774|NCT00862979|BG001|Baseline|CNI-free-regimen|CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
11234971|NCT02438787|FG001|Participant Flow|Ustekinumab 45mg|Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
11234972|NCT02438787|FG002|Participant Flow|Ustekinumab 90mg|Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
11234973|NCT02438787|OG000|Outcome|Placebo|Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
11234974|NCT02438787|OG001|Outcome|Ustekinumab 45mg|Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
11234975|NCT02438787|OG002|Outcome|Ustekinumab 90mg|Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
11234976|NCT02438787|EG000|Reported Event|Placebo|Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing. Included all participants, but adverse events for participants who early escaped at Week 16 or crossed over at Week 24 are only counted up to Week 16 or Week 24 respectively.
11234977|NCT02438787|EG001|Reported Event|Placebo to Golimumab|Participants randomized to placebo SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
11234978|NCT02438787|EG002|Reported Event|Placebo to Ustekinumab 45mg|Participants randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward.
11234979|NCT02438787|EG003|Reported Event|Placebo to Ustekinumab 90mg|Participants randomized to placebo SC and then rerandomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward.
11234980|NCT02438787|EG004|Reported Event|Ustekinumab 45mg Only|Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing. Adverse events for participants who early escaped at Week 16 are only counted up to Week 16.
11234981|NCT02438787|EG005|Reported Event|Ustekinumab 45mg to Golimumab|Participants randomized to ustekinumab 45 mg SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
11234982|NCT02438787|EG006|Reported Event|Ustekinumab 90mg Only|Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing. Adverse events for participants who early escaped at Week 16 are only counted up to Week 16.
11234983|NCT02438787|EG007|Reported Event|Ustekinumab 90mg to Golimumab|Participants randomized to ustekinumab 90 mg SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
11234984|NCT02438813|BG000|Baseline|All Enrolled Participants|All enrolled participants who signed informed consent whether or not they elected to receive treatment as per standard of care in clinical practice for submental fat (SMF). Treatments for SMF included: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments.
11234985|NCT02438813|FG000|Participant Flow|All Enrolled Participants|All enrolled participants who signed informed consent whether or not they elected to receive treatment as per standard of care in clinical practice for submental fat (SMF). Treatments for SMF included: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments.
11234986|NCT02438813|OG000|Outcome|Deoxycholic Acid (ATX-101)|Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care.
11234987|NCT02438813|OG001|Outcome|Surgical|Surgical procedures for the treatment of SMF as per standard of care in clinical practice.
10961775|NCT00862979|BG002|Baseline|Total|Total of all reporting groups
11234988|NCT02438813|OG002|Outcome|Laser Liposuction|Laser Liposuction for treatment of SMF as per standard of care in clinical practice.
10847256|NCT00282412|BG000|Baseline|Hematopoietic Stem Cell Transplantation|"Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA~Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation"
10847257|NCT00282412|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|"Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA~Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation"
10847258|NCT00282412|OG000|Outcome|Hematopoietic Stem Cell Transplantation|"Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA~Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation"
11234989|NCT02438813|OG003|Outcome|Energy Devices|Energy Devices as treatment for SMF as per standard of care in clinical practice.
11234990|NCT02438813|OG004|Outcome|Other Treatments|Other Treatments for treatment of SMF as per standard of care in clinical practice.
11234991|NCT02438813|OG005|Outcome|Not Elected Treatment|All enrolled participants who did not elect to have treatment for SMF.
11234992|NCT02438813|EG000|Reported Event|Deoxycholic Acid (ATX-101)|Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care.
10961776|NCT00862979|FG000|Participant Flow|CNI-regimen|CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
10961777|NCT00862979|FG001|Participant Flow|CNI-free-regimen|CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
11180518|NCT02062450|OG000|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
11180519|NCT02062450|OG001|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
11180520|NCT02062450|EG000|Reported Event|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
11180521|NCT02062450|EG001|Reported Event|Primary Surgery Sub-group|Patients who underwent a Primary Hip Replacement surgery
11180522|NCT02062450|EG002|Reported Event|Revision Surgery Sub-group|Patients who underwent a Revision Hip Replacement surgery
11180523|NCT02062502|BG000|Baseline|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
11180524|NCT02062502|BG001|Baseline|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
11180525|NCT02062502|BG002|Baseline|Total|Total of all reporting groups
11180526|NCT02062502|FG000|Participant Flow|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
11180527|NCT02062502|FG001|Participant Flow|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
11180528|NCT02062502|OG000|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
11180529|NCT02062502|OG001|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
11180530|NCT02062502|EG000|Reported Event|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
11180531|NCT02062502|EG001|Reported Event|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
11180532|NCT02062580|BG000|Baseline|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
11180533|NCT02062580|BG001|Baseline|Early BCG|"BCG at birth; standard of care~BCG"
11180534|NCT02062580|BG002|Baseline|Total|Total of all reporting groups
11180535|NCT02062580|FG000|Participant Flow|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
11180536|NCT02062580|FG001|Participant Flow|Early BCG|"BCG at birth; standard of care~BCG"
11180537|NCT02062580|OG000|Outcome|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
11180538|NCT02062580|OG001|Outcome|Early BCG|"BCG at birth; standard of care~BCG"
11180539|NCT02062580|EG000|Reported Event|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
10961778|NCT00862979|OG000|Outcome|CNI-regimen|CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
11180540|NCT02062580|EG001|Reported Event|Early BCG|"BCG at birth; standard of care~BCG"
11180541|NCT02062593|BG000|Baseline|Coronary Angioplasty and Optimum Medical Therapy|"Percutaneous coronary intervention and optimal medical therapy~Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques"
11180542|NCT02062593|BG001|Baseline|Sham Procedure and Optimum Medical Therapy|"Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy~Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques"
11180543|NCT02062593|BG002|Baseline|Total|Total of all reporting groups
11180544|NCT02062593|FG000|Participant Flow|Coronary Angioplasty and Optimum Medical Therapy|"Percutaneous coronary intervention and optimal medical therapy~Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques"
11180545|NCT02062593|FG001|Participant Flow|Sham Procedure and Optimum Medical Therapy|"Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy~Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques"
11180546|NCT02062593|OG000|Outcome|Coronary Angioplasty and Optimum Medical Therapy|"Percutaneous coronary intervention and optimal medical therapy~Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques"
11180547|NCT02062593|OG001|Outcome|Sham Procedure and Optimum Medical Therapy|"Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy~Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques"
11180548|NCT02062593|EG000|Reported Event|Coronary Angioplasty and Optimum Medical Therapy|"Percutaneous coronary intervention and optimal medical therapy~Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques"
11180549|NCT02062593|EG001|Reported Event|Sham Procedure and Optimum Medical Therapy|"Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy~Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques"
11180550|NCT02062606|BG000|Baseline|Demographics and Baseline Characteristics|This is a demographic and baseline characteristics of the patient population. This includes parameters such as Age, Gender, Height, Weight Body Mass Index (BMI) and Tobacco Usage.
11234993|NCT02438813|EG001|Reported Event|Surgical|Surgical procedures for the treatment of SMF as per standard of care in clinical practice.
11234994|NCT02438813|EG002|Reported Event|Laser Liposuction|Laser Liposuction for treatment of SMF as per standard of care in clinical practice.
11234995|NCT02438813|EG003|Reported Event|Energy Devices|Energy Devices as treatment for SMF as per standard of care in clinical practice.
11234996|NCT02438813|EG004|Reported Event|Other Treatments|Other Treatments for treatment of SMF as per standard of care in clinical practice.
11234997|NCT02438813|EG005|Reported Event|All Treated Participants|All participants who received treatment for SMF as per standard of care in clinical practice: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments.
11234998|NCT02438826|BG000|Baseline|Placebo|Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
11234999|NCT02438826|BG001|Baseline|Galcanezumab 300 mg|Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
11235000|NCT02438826|BG002|Baseline|Total|Total of all reporting groups
11235001|NCT02438826|FG000|Participant Flow|Placebo/Galcanezumab (GMB) 300 mg|"Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.~Open-Label Treatment Phase: Participants from placebo group received 300 milligrams (mg) of galcanezumab (GMB) by subcutaneous injection every 30 days, for up to a total of 12 administrations.~Post-Treatment Phase: Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period."
11235002|NCT02438826|FG001|Participant Flow|GMB 300 mg/GMB 300 mg|"Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.~Open-Label Treatment Phase: Participants from galcanezumab group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.~Post-Treatment Phase: Post-Treatment Phase: Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period."
11235003|NCT02438826|FG002|Participant Flow|Placebo (Post-Treatment Phase)|Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
11235004|NCT02438826|FG003|Participant Flow|Galcanezumab 300 mg (Post-Treatment Phase)|Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
11235005|NCT02438826|OG000|Outcome|Placebo|Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
11235006|NCT02438826|OG001|Outcome|Galcanezumab 300 mg|Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
11235007|NCT02438826|OG000|Outcome|Placebo|Placebo administered by SQ injection every 30 Days for 12 weeks.
11235008|NCT02438826|OG001|Outcome|Galcanezumab 300 mg|300 mg galcanezumab (LY2951742) administered by subcutaneous (SQ) injection every 30 days for 12 weeks.
11235009|NCT02438826|OG000|Outcome|Galcanezumab 300 mg|Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
11235010|NCT02438826|EG000|Reported Event|Placebo (Double-Blind Treatment Phase)|Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
11235011|NCT02438826|EG001|Reported Event|Galcanezumab 300 mg (Double-Blind Treatment Phase)|Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months
11235012|NCT02438826|EG002|Reported Event|Placebo/GMB 300 mg (Open-Label Treatment Phase)|Participants from placebo group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.
11235013|NCT02438826|EG003|Reported Event|GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase)|Participants from galcanezumab of double-blind group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.
11235014|NCT02438826|EG004|Reported Event|Placebo (Post-Treatment Phase)|Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
11235015|NCT02438826|EG005|Reported Event|Galcanezumab 300 mg (Post-Treatment Phase)|Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
10961779|NCT00862979|OG001|Outcome|CNI-free-regimen|CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
11235016|NCT02438826|EG006|Reported Event|Placebo/GMB 300 mg (Post-Treatment Phase)|Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
11235017|NCT02438826|EG007|Reported Event|GMB 300 mg/GMB 300 Mg-Post-Treatment Phase|Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
11235018|NCT02439138|BG000|Baseline|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
11235019|NCT02439138|FG000|Participant Flow|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
11235020|NCT02439138|OG000|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
11235021|NCT02439138|EG000|Reported Event|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
11235022|NCT02439164|BG000|Baseline|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
10847259|NCT00282412|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|"Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA~Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation"
11180551|NCT02062606|FG000|Participant Flow|K2M MESA Rail™ Deformity System|"Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail Deformity System that had:~Diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles were noted but not restrictive).~An age at time of surgery of ≥ 11 years old and ≤ 21 years old"
11180552|NCT02062606|OG000|Outcome|All Patients|The overall change of Thoracic Kyphosis (TK) within the current study.
11180553|NCT02062606|OG000|Outcome|Up to Post-Operative|participants with SAE and AE
11180554|NCT02062606|OG001|Outcome|Post-Operative to 3 Months|participants with SAE and AE
11180555|NCT02062606|OG002|Outcome|3 to 6 Months|participants with SAE and AE
11180556|NCT02062606|OG003|Outcome|6 to 12 Months|participants with SAE and AE
11180557|NCT02062606|OG004|Outcome|12 to 24+ Months|participants with SAE and AE
11180558|NCT02062606|OG005|Outcome|Overall|Overall number of participants with SAE and AEs
11180559|NCT02062606|OG000|Outcome|Back|pain scores on the VAS
11180560|NCT02062606|OG001|Outcome|Left Leg/Hip|pain scores on the VAS
11180561|NCT02062606|OG002|Outcome|Right Leg/Hip|pain scores on the VAS
11180562|NCT02062606|OG000|Outcome|24 Month|Baseline in quality of life scores on the SRS-22r
11180563|NCT02062606|OG000|Outcome|12 Month|Patient satisfaction at 12 Month
11180564|NCT02062606|OG001|Outcome|24 Month|Patient satisfaction at 12 Month
11180565|NCT02062606|OG000|Outcome|Investigator's Rating|Investigator's rating of subject's clinical disposition using Odom's Criteria
11180566|NCT02062606|OG000|Outcome|Length of Surgery Time|The length of the surgical procedure from the initial incision to final closure
11180567|NCT02062606|OG000|Outcome|Length of Anesthesia Time|The length of time the patient is under anesthesia was captured.
11180568|NCT02062606|OG000|Outcome|Estimated Blood Loss|The amount of blood loss over the entire length of the surgery was captured.
11180569|NCT02062606|OG000|Outcome|Length of Hospital Stay|The length of the hospital stay from the date of admission to the date of discharge
11180570|NCT02062606|OG000|Outcome|Pre-Op|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
11180571|NCT02062606|OG001|Outcome|Initial Post Op|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
11180572|NCT02062606|OG002|Outcome|3 Month|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
11180573|NCT02062606|OG003|Outcome|6 Month|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
11180574|NCT02062606|OG004|Outcome|12 Month|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
11180575|NCT02062606|OG005|Outcome|24 Month|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
11180576|NCT02062606|OG000|Outcome|Pre-Op|The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.
11180577|NCT02062606|OG001|Outcome|Initial Post Op|The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.
11180578|NCT02062606|OG002|Outcome|3 Month|The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.
11180579|NCT02062606|OG003|Outcome|6 Month|The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.
11180580|NCT02062606|OG004|Outcome|12 Month|The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.
11180581|NCT02062606|OG005|Outcome|24 Month|The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.
11180582|NCT02062606|EG000|Reported Event|Participants With Adverse Events|"Overall participants with any AE or SAE.~5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories.~The study did not establish a frequency threshold, therefore, all AEs are listed."
11180583|NCT02062632|BG000|Baseline|Placebo|Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
11180584|NCT02062632|FG000|Participant Flow|Placebo|Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
11180585|NCT02062632|OG000|Outcome|Placebo|Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
11180586|NCT02062632|EG000|Reported Event|Placebo|Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
11180587|NCT02062645|BG000|Baseline|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
11180588|NCT02062645|FG000|Participant Flow|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
11180589|NCT02062645|OG000|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
11180590|NCT02062645|EG000|Reported Event|Amlodipine/Valsartan|amlodipine/valsartan
11180591|NCT02062658|BG000|Baseline|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
11180592|NCT02062658|FG000|Participant Flow|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
11180593|NCT02062658|OG000|Outcome|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
11180594|NCT02062658|EG000|Reported Event|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
11180595|NCT02062710|BG000|Baseline|Diphenhydramine/Phenylephrine/Cocoa, Dextromethorphan,Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; dextromethorphan; placebo.~Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine~Dextromethorphan: 30 mg dose dextromethorphan"
11180596|NCT02062710|FG000|Participant Flow|Diphenhydramine/Phen/Cocoa, Dextromethorphan, Then Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; then dextromethorphan 30 mg; then placebo.~Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Washout 1-2 days between each of the 3 dosing periods."
11180597|NCT02062710|FG001|Participant Flow|Diphenhydramine/Phenylephrine/Cocoa, Then Placebo, Then Dextro|"diphenhydramine 25 mg and phenylephrine 10 mg; then placebo; then dextromethorphan 30 mg.~Intervention: capsaicin cough challenge testing after study drug ingestion"
11180598|NCT02062710|FG002|Participant Flow|Dextromethorphan, Diphenhydramine/Phenylephrine/Cocoa, Then pl|dextromethorphan 30 mg, then diphenhydramine/phenylephrine/cocoa, then placebo. Intervention: capsaicin cough challeneg 2 hours after study drug ingestion
11180599|NCT02062710|FG003|Participant Flow|Dextromethorphan, Placebo, Then Diphenhydramine/Phenylephrine/|"dextromethorphan 30 mg, then placebo, then diphenhydramine 25 mg and phenylephrine 10 mg.~Intervention: capsaicin cough challenge 2 hours after study drug ingestion. Washout period 1-2 days between each of the 3 dosing periods"
11180600|NCT02062710|FG004|Participant Flow|Placebo, Diphenhydramine/Phenylephrine/Cocoa, Then Dextrometho|"placebo, then diphenhydramine 25 mg and phenylephrine 10 mg, then dextromethorphan 30 mg.~Intervention: capsaicin cough challenge 2 hours after study drug administration.~Washout period 1-2 days after each of the 3 dosing periods"
11180601|NCT02062710|FG005|Participant Flow|Placebo, Dextromethorphan, Then Diphenhydramine/Phenylephrine/|"placebo, then dextromethorphan 30 mg, then diphenhydramine 25 mg and phenylephrine 10 mg.~Intervention: capsaicin cough challenge 2 hours after study drug administration.~Washout period 1-2 days after each of the 3 dosing periods."
11180602|NCT02062710|OG000|Outcome|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine"
11180603|NCT02062710|OG001|Outcome|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Dextromethorphan: 30 mg dose dextromethorphan"
11180604|NCT02062710|OG002|Outcome|Placebo|placebo liquid, dextrose in water, 20 mL
11180605|NCT02062710|EG000|Reported Event|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine"
11180606|NCT02062710|EG001|Reported Event|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Dextromethorphan: 30 mg dose dextromethorphan"
11180607|NCT02062710|EG002|Reported Event|Placebo|placebo liquid, dextrose in water, 20 mL
11180608|NCT02062801|BG000|Baseline|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
11180609|NCT02062801|BG001|Baseline|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
11180610|NCT02062801|BG002|Baseline|Total|Total of all reporting groups
11180611|NCT02062801|FG000|Participant Flow|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
11180612|NCT02062801|FG001|Participant Flow|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
11180613|NCT02062801|OG000|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
11180614|NCT02062801|OG001|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
11180615|NCT02062801|EG000|Reported Event|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
11180616|NCT02062801|EG001|Reported Event|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
11235023|NCT02439164|BG001|Baseline|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
11235024|NCT02439164|BG002|Baseline|Total|Total of all reporting groups
11180617|NCT02062879|BG000|Baseline|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
11180618|NCT02062879|BG001|Baseline|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
11180619|NCT02062879|BG002|Baseline|Total|Total of all reporting groups
11180620|NCT02062879|FG000|Participant Flow|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
11180621|NCT02062879|FG001|Participant Flow|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
11180622|NCT02062879|OG000|Outcome|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
11180623|NCT02062879|OG001|Outcome|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
11180624|NCT02062879|EG000|Reported Event|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
11180625|NCT02062879|EG001|Reported Event|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
11180626|NCT02062905|BG000|Baseline|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
11180627|NCT02062905|BG001|Baseline|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
11180628|NCT02062905|BG002|Baseline|Total|Total of all reporting groups
11180629|NCT02062905|FG000|Participant Flow|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
11180630|NCT02062905|FG001|Participant Flow|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
11180631|NCT02062905|OG000|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
11180632|NCT02062905|OG001|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
11180633|NCT02062905|EG000|Reported Event|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
11180634|NCT02062905|EG001|Reported Event|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
11180635|NCT02063035|BG000|Baseline|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
11180636|NCT02063035|BG001|Baseline|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
11180637|NCT02063035|BG002|Baseline|Total|Total of all reporting groups
11180638|NCT02063035|FG000|Participant Flow|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 grams (g) tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
11180639|NCT02063035|FG001|Participant Flow|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
11180640|NCT02063035|OG000|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
11180641|NCT02063035|OG001|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
11180642|NCT02063035|EG000|Reported Event|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
11180643|NCT02063035|EG001|Reported Event|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
11180644|NCT02063087|BG000|Baseline|Decision Aid|"Head CT Decision Aid~Head CT Decision Aid: The decision aid, Head CT Choice, educates parents regarding how the clinician determined the severity of their child's head trauma, their child's quantitative risk for a clinically-important TBI, the pros and cons of cranial CT compared to active observation, and what signs and symptoms parents should watch for in the next 24 hours that should prompt a return visit to the ED."
11180645|NCT02063087|BG001|Baseline|Usual Care|Clinicians and patients do not have access to the Head CT Decision Aid
11180646|NCT02063087|BG002|Baseline|Total|Total of all reporting groups
11180647|NCT02063087|FG000|Participant Flow|Decision Aid|"Head CT Decision Aid~Head CT Decision Aid: The decision aid, Head CT Choice, educates parents regarding how the clinician determined the severity of their child's head trauma, their child's quantitative risk for a clinically-important TBI, the pros and cons of cranial CT compared to active observation, and what signs and symptoms parents should watch for in the next 24 hours that should prompt a return visit to the ED."
11180648|NCT02063087|FG001|Participant Flow|Usual Care|Clinicians and patients do not have access to the Head CT Decision Aid
11180649|NCT02063087|OG000|Outcome|Decision Aid|"Head CT Decision Aid~Head CT Decision Aid: The decision aid, Head CT Choice, educates parents regarding how the clinician determined the severity of their child's head trauma, their child's quantitative risk for a clinically-important TBI, the pros and cons of cranial CT compared to active observation, and what signs and symptoms parents should watch for in the next 24 hours that should prompt a return visit to the ED."
10961780|NCT00862979|EG000|Reported Event|CNI-regimen|CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
11180650|NCT02063087|OG001|Outcome|Usual Care|Clinicians and patients do not have access to the Head CT Decision Aid
11180651|NCT02063087|EG000|Reported Event|Decision Aid|"Head CT Decision Aid~Head CT Decision Aid: The decision aid, Head CT Choice, educates parents regarding how the clinician determined the severity of their child's head trauma, their child's quantitative risk for a clinically-important TBI, the pros and cons of cranial CT compared to active observation, and what signs and symptoms parents should watch for in the next 24 hours that should prompt a return visit to the ED."
11180652|NCT02063087|EG001|Reported Event|Usual Care|Clinicians and patients do not have access to the Head CT Decision Aid
11180653|NCT02063178|BG000|Baseline|Counselor-Initiated|"Will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion.~Phone-based sessions (28 total) on a struct"
11180654|NCT02063178|BG001|Baseline|Self-Paced|Uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week.
11180655|NCT02063178|BG002|Baseline|Total|Total of all reporting groups
11180656|NCT02063178|FG000|Participant Flow|Counselor-Initiated|Will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion.
11180657|NCT02063178|FG001|Participant Flow|Self-Paced|Uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week.
11180658|NCT02063178|OG000|Outcome|Counselor-Initiated|"Will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion.~Phone-based sessions (28 total) on a struct"
11180659|NCT02063178|OG001|Outcome|Self-Paced|Uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week.
11180660|NCT02063178|OG000|Outcome|Counselor-Initiated|"28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion.~Phone-based sessions (28 total) on a structured schedule"
11235025|NCT02439164|FG000|Participant Flow|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
10961781|NCT00862979|EG001|Reported Event|CNI-free-regimen|CNI-free regimen: MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and everolimus and corticosteroids; On month 6 to 9 only: Cyclosporin A or tacrolimus
10961782|NCT00862992|BG000|Baseline|Cariprazine 3 mg|
10961783|NCT00862992|BG001|Baseline|Cariprazine 6 mg|
11180661|NCT02063178|OG001|Outcome|Self-Paced|"Participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week.~Phone-based sessions upon request: For those individuals randomly assigned to the self-paced condition, the 28 sessions are still available to them, the participant has to call to initiate sessions.~Weight self-monitoring: Each randomized participant will be given a Body Trace scale that will electronically record their weight.~Dietary and physical activity self-monitoring: Each randomized p"
11180662|NCT02063178|OG000|Outcome|Counselor-Initiated|"28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques~Monitor food intake and physical activity using the LoseIt website/app and weigh daily using a Body Trace e-scale~Feedback on self-monitoring through e-mail.~Dietary goals will be based on weight and participants' weight-loss progress.~Encouraged to replace 2 meals and a snack with meal replacements (provided).~Gradually increase moderate to vigorous exercise to 225-250 minutes per week.~Toolbox with additional treatment options (e.g., food scales, exercise videos, cookbooks)~Challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion."
11180663|NCT02063178|OG001|Outcome|Self-Paced|The Self-paced group uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week.
11180664|NCT02063178|EG000|Reported Event|Counselor-Initiated|Participants will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion.
11180665|NCT02063178|EG001|Reported Event|Self-Paced|The Self-paced group uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week.
11180666|NCT02063217|BG000|Baseline|Sleep Induction|"6.5-7.5 grams of sodium oxybate~Sodium Oxybate: Sodium oxybate h.s."
11180667|NCT02063217|BG001|Baseline|Sleep Deprivation|"Sleep deprivation for up to 36 hours with no naps or other sleep periods~Sleep deprivation: 36hr sleep deprivation"
11180668|NCT02063217|BG002|Baseline|Control|Participant will sleep as normal under the same controlled conditions in a clinical research unit
11180669|NCT02063217|BG003|Baseline|Total|Total of all reporting groups
11180670|NCT02063217|FG000|Participant Flow|Sleep Induction|"6.5-7.5 grams of sodium oxybate~Sodium Oxybate: Sodium oxybate h.s."
11180671|NCT02063217|FG001|Participant Flow|Sleep Deprivation|"Sleep deprivation for up to 36 hours with no naps or other sleep periods~Sleep deprivation: 36hr sleep deprivation"
11180672|NCT02063217|FG002|Participant Flow|Control|Participant will sleep as normal under the same controlled conditions in a clinical research unit
11180673|NCT02063217|OG000|Outcome|Sleep Induction|"6.5-7.5 grams of sodium oxybate~Sodium Oxybate: Sodium oxybate h.s."
11180674|NCT02063217|OG001|Outcome|Sleep Deprivation|"Sleep deprivation for up to 36 hours with no naps or other sleep periods~Sleep deprivation: 36hr sleep deprivation"
11180675|NCT02063217|OG002|Outcome|Control|Participant will sleep as normal under the same controlled conditions in a clinical research unit
11180676|NCT02063217|EG000|Reported Event|Sleep Induction|"6.5-7.5 grams of sodium oxybate~Sodium Oxybate: Sodium oxybate h.s."
11180677|NCT02063217|EG001|Reported Event|Sleep Deprivation|"Sleep deprivation for up to 36 hours with no naps or other sleep periods~Sleep deprivation: 36hr sleep deprivation"
11180678|NCT02063217|EG002|Reported Event|Control|Participant will sleep as normal under the same controlled conditions in a clinical research unit
11180679|NCT02063230|BG000|Baseline|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
11180680|NCT02063230|BG001|Baseline|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
11180681|NCT02063230|BG002|Baseline|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
11180682|NCT02063230|BG003|Baseline|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
11180683|NCT02063230|BG004|Baseline|Total|Total of all reporting groups
10961784|NCT00862992|BG002|Baseline|Cariprazine 12.5 mg|
10961785|NCT00862992|BG003|Baseline|Total|Total of all reporting groups
10961786|NCT00862992|FG000|Participant Flow|Cariprazine 3 mg|
10961787|NCT00862992|FG001|Participant Flow|Cariprazine 6 mg|
10961788|NCT00862992|FG002|Participant Flow|Cariprazine 12.5 mg|
10961789|NCT00862992|OG000|Outcome|Cariprazine 3 mg|
10961790|NCT00862992|OG001|Outcome|Cariprazine 6 mg|
10961791|NCT00862992|OG002|Outcome|Cariprazine 12.5 mg|
11235026|NCT02439164|FG001|Participant Flow|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
11235027|NCT02439164|OG000|Outcome|Glioma Group|"Patients in this group will be administered sedative midazolam titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
11235028|NCT02439164|OG001|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
11235029|NCT02439164|OG000|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
11235030|NCT02439164|EG000|Reported Event|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
11235031|NCT02439164|EG001|Reported Event|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
11235032|NCT02439281|BG000|Baseline|Ropivacaine Group|"Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235033|NCT02439281|BG001|Baseline|Ropivacaine/ Clonidine Group|"Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235034|NCT02439281|BG002|Baseline|Total|Total of all reporting groups
11235035|NCT02439281|FG000|Participant Flow|Ropivacaine Group|"Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235036|NCT02439281|FG001|Participant Flow|Ropivacaine/ Clonidine Group|"Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235037|NCT02439281|OG000|Outcome|Ropivacaine/ Clonidine Group|"Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235038|NCT02439281|OG001|Outcome|Ropivacaine Group|"Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235039|NCT02439281|OG000|Outcome|Ropivacaine Group|"Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235040|NCT02439281|OG001|Outcome|Ropivacaine/ Clonidine Group|"Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
10961792|NCT00862992|EG000|Reported Event|Cariprazine 3 mg|
10961793|NCT00862992|EG001|Reported Event|Cariprazine 6 mg|
11235041|NCT02439281|EG000|Reported Event|Ropivacaine/ Clonidine Group|"Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235042|NCT02439281|EG001|Reported Event|Ropivacaine Group|"Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.~Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block"
11235043|NCT02439320|BG000|Baseline|100 mg Lasmiditan|100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose
11235044|NCT02439320|BG001|Baseline|200 mg Lasmiditan|200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
11235045|NCT02439320|BG002|Baseline|Placebo|Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
11235046|NCT02439320|BG003|Baseline|Total|Total of all reporting groups
11235047|NCT02439320|FG000|Participant Flow|100 mg Lasmiditan|100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
11235048|NCT02439320|FG001|Participant Flow|200 mg Lasmiditan|200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
11235049|NCT02439320|FG002|Participant Flow|Placebo|Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
11235050|NCT02439320|OG000|Outcome|100 mg Lasmiditan|100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
11235051|NCT02439320|OG001|Outcome|200 mg Lasmiditan|200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
11235052|NCT02439320|OG002|Outcome|Placebo|Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
11235053|NCT02439320|OG001|Outcome|200 mg Lasmiditan|200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose
11235054|NCT02439320|OG000|Outcome|100 mg Lasmiditan/100 mg Lasmiditan|100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. An optional 100 mg Lasmiditan dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11235055|NCT02439320|OG001|Outcome|100 mg Lasmiditan/Placebo|100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11235056|NCT02439320|OG002|Outcome|200 mg Lasmiditan/200 mg Lasmiditan|100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. An optional 100 mg lasmiditan dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11235057|NCT02439320|OG003|Outcome|200 mg Lasmiditan/Placebo|200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11235058|NCT02439320|OG004|Outcome|Placebo/Placebo|Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11235059|NCT02439320|EG000|Reported Event|100 mg Lasmiditan|Any participant who received 100 milligrams (mg) lasmiditan administered PO.
11235060|NCT02439320|EG001|Reported Event|200 mg Lasmiditan|Any participant who received 200 milligrams (mg) lasmiditan administered PO.
11235061|NCT02439320|EG002|Reported Event|Placebo|Any participant who received placebo administered PO.
11235062|NCT02439710|BG000|Baseline|Enrolled Population|Patients with hemophilia A or hemophilia B with any degree of disease severity or controls
11235063|NCT02439710|FG000|Participant Flow|Enrolled Participants|"Patients with hemophilia (haemophilia A or B with any degree of disease severity) or Controls (individuals with no bleeding disorders)"
11235064|NCT02439710|OG000|Outcome|Enrolled Participants|"Patients with hemophilia (haemophilia A or B with any degree of disease severity) or Controls (individuals with no bleeding disorders)"
11235065|NCT02439710|EG000|Reported Event|Enrolled Participants|"Patients with hemophilia (haemophilia A or B with any degree of disease severity) or Controls (individuals with no bleeding disorders)"
11235066|NCT02439814|BG000|Baseline|Pregnenolone|Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication
11235067|NCT02439814|BG001|Baseline|Placebo|Placebo: Inactive comparator
11235068|NCT02439814|BG002|Baseline|Total|Total of all reporting groups
11235069|NCT02439814|FG000|Participant Flow|Pregnenolone|Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication
11235070|NCT02439814|FG001|Participant Flow|Placebo|Placebo: Inactive comparator
11235071|NCT02439814|OG000|Outcome|Pregnenolone|Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication
11235072|NCT02439814|OG001|Outcome|Placebo|Placebo: Inactive comparator
11235073|NCT02439814|EG000|Reported Event|Pregnenolone|Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication
11235074|NCT02439814|EG001|Reported Event|Placebo|Placebo: Inactive comparator
11235075|NCT02439879|BG000|Baseline|Alpha Lipoic Acid Treatment|"After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid~Alpha lipoic acid: Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased >3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks."
11235076|NCT02439879|BG001|Baseline|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
11235077|NCT02439879|BG002|Baseline|Total|Total of all reporting groups
11235078|NCT02439879|FG000|Participant Flow|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
11235079|NCT02439879|FG001|Participant Flow|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
11235080|NCT02439879|OG000|Outcome|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
11235081|NCT02439879|OG001|Outcome|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
11235082|NCT02439879|EG000|Reported Event|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
10961794|NCT00862992|EG002|Reported Event|Cariprazine 12.5 mg|
11235083|NCT02439879|EG001|Reported Event|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
11235084|NCT02440022|BG000|Baseline|Lutonix DCB|"Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.~Lutonix DCB~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
11235085|NCT02440022|BG001|Baseline|Standard Balloon Angioplasty Catheter|"Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Standard Balloon Angioplasty Catheter~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
11235086|NCT02440022|BG002|Baseline|Total|Total of all reporting groups
11235087|NCT02440022|FG000|Participant Flow|Lutonix DCB|"Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.~Lutonix DCB~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
11235088|NCT02440022|FG001|Participant Flow|Standard Balloon Angioplasty Catheter|"Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Standard Balloon Angioplasty Catheter~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
10847260|NCT00282438|BG000|Baseline|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
10847261|NCT00282438|BG001|Baseline|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
10847262|NCT00282438|BG002|Baseline|Total|Total of all reporting groups
10961795|NCT00863057|BG000|Baseline|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
10961796|NCT00863057|BG001|Baseline|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
10963894|NCT00874770|OG003|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).48 weeks.
11235089|NCT02440022|OG000|Outcome|Lutonix DCB|"Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.~Lutonix DCB~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
11235090|NCT02440022|OG001|Outcome|Standard Balloon Angioplasty Catheter|"Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Standard Balloon Angioplasty Catheter~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
11235091|NCT02440022|EG000|Reported Event|Lutonix DCB|"Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.~Lutonix DCB~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
11235092|NCT02440022|EG001|Reported Event|Standard Balloon Angioplasty Catheter|"Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Standard Balloon Angioplasty Catheter~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
11235093|NCT02440139|BG000|Baseline|Arm 1: Baseline Study|12 participating radiologists performed clinical reading on 324 cases. They marked all locations of concern (clinically actionable nodules) on conventional thoracic CT images. Computer measured time, readers score regions according to action and suspiciousness.
11235094|NCT02440139|FG000|Participant Flow|Arm 1|Participating radiologists performed clinical reading on 328 cases. They marked all locations of concern (clinically actionable nodules) on conventional thoracic CT images. Computer measured time, readers score regions according to action and suspiciousness.
11235095|NCT02440139|OG000|Outcome|Arm 1|Participating radiologists performed a clinical reading on the study cases. They marked all locations of concern (clinically actionable nodules) on conventional thoracic CT images. Computer measured time, readers score regions according to action and suspiciousness.
11235096|NCT02440139|OG001|Outcome|Arm 2|"Participating radiologists performed clinical reading on the study cases. They marked all locations of concern (clinically actionable nodules) on thoracic CT images aided by ClearRead CT Insight software as the intervention. Computer measured time, readers score regions according to action and suspiciousness.~ClearRead CT Insight: During the second reading session (concurrent read), the radiologist was presented with a standard appearing CT with CADe marks placed and the vessel suppressed images with the vessel suppressed view as the intervention. The second image, vessel suppressed, was not shown until the radiologist move the mouse to the second panel. The radiologist will mark locations. These may or may not correspond to the locations of the CAD markers. As before, the radiologist then assigned a level of suspicious to each mark and indicate the need, if any, of an additional diagnostic action (CT Follow-up, Contrast CT, PET-CT, or Biopsy)."
11235097|NCT02440139|OG000|Outcome|Arm 1|Participating radiologists performed a clinical reading on the study cases. They will mark all locations of concern (clinically actionable nodules) on conventional thoracic CT images. Computer measured time, readers score regions according to action and suspiciousness.
10963895|NCT00874770|OG003|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets once daily for 48 weeks coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10963896|NCT00874770|EG000|Reported Event|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11180684|NCT02063230|FG000|Participant Flow|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
11180685|NCT02063230|FG001|Participant Flow|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
11180686|NCT02063230|FG002|Participant Flow|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
11180687|NCT02063230|FG003|Participant Flow|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
11180688|NCT02063230|OG000|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
11180689|NCT02063230|OG001|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
11180690|NCT02063230|OG002|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
11180691|NCT02063230|OG003|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
11180692|NCT02063230|EG000|Reported Event|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
11180693|NCT02063230|EG001|Reported Event|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
11180694|NCT02063230|EG002|Reported Event|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
11180695|NCT02063230|EG003|Reported Event|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
11180696|NCT02063516|BG000|Baseline|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
11180697|NCT02063516|BG001|Baseline|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
11180698|NCT02063516|BG002|Baseline|Total|Total of all reporting groups
11180699|NCT02063516|FG000|Participant Flow|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
11180700|NCT02063516|FG001|Participant Flow|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
11180701|NCT02063516|OG000|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
11180702|NCT02063516|OG001|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
11180703|NCT02063516|EG000|Reported Event|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
11180704|NCT02063516|EG001|Reported Event|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
11180705|NCT02063659|BG000|Baseline|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180706|NCT02063659|BG001|Baseline|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180707|NCT02063659|BG002|Baseline|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
11180708|NCT02063659|BG003|Baseline|Total|Total of all reporting groups
11180709|NCT02063659|FG000|Participant Flow|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180710|NCT02063659|FG001|Participant Flow|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180711|NCT02063659|FG002|Participant Flow|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
11180712|NCT02063659|FG003|Participant Flow|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
11180713|NCT02063659|OG000|Outcome|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180714|NCT02063659|OG001|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180715|NCT02063659|OG002|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
11180716|NCT02063659|OG000|Outcome|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
11180717|NCT02063659|OG001|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks, followed by a 36 week open-label extension period.
11180718|NCT02063659|OG002|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 Week double-blind treatment period, followed by a 36 week open-label extension period.
11180719|NCT02063659|OG000|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180720|NCT02063659|OG001|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
11180721|NCT02063659|EG000|Reported Event|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180722|NCT02063659|EG001|Reported Event|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
11180723|NCT02063659|EG002|Reported Event|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
11180724|NCT02063659|EG003|Reported Event|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
11180725|NCT02063672|BG000|Baseline|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
11180726|NCT02063672|BG001|Baseline|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
11180727|NCT02063672|BG002|Baseline|Total|Total of all reporting groups
11180728|NCT02063672|FG000|Participant Flow|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
11180729|NCT02063672|FG001|Participant Flow|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
11180730|NCT02063672|OG000|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
11180731|NCT02063672|OG001|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
11235098|NCT02440139|OG001|Outcome|Arm 2|"Participating radiologists performed a clinical reading on the study cases. They marked all locations of concern (clinically actionable nodules) on thoracic CT images aided by ClearRead CT Insight software as the intervention. Computer measured time, readers score regions according to action and suspiciousness.~ClearRead CT Insight: During the second reading session (concurrent read), the radiologist was presented with a standard appearing CT with CADe marks placed and the vessel suppressed the same slice with the vessel suppressed view as the intervention. The second image, vessel suppressed, was not shown until the radiologist moves the mouse to the second panel. The radiologist will mark locations. These may or may not correspond to the locations of the CAD markers. As before, the radiologist then assigned a level of suspicion to each mark and indicate the need, if any, for an additional diagnostic action (CT Follow-up, Contrast CT, PET-CT, or Biopsy)."
11235099|NCT02440139|EG000|Reported Event|Arm 1|12 Participating radiologists performed a clinical reading on 324 cases. They marked all locations of concern (clinically actionable nodules) on conventional thoracic CT images. Computer measured time, readers score, and regions according to action and suspiciousness.
11235100|NCT02440139|EG001|Reported Event|Arm 2|"12 Participating radiologists performed clinical reading on 324 cases. They marked all locations of concern (clinically actionable nodules) on thoracic CT images aided by ClearRead CT Insight software as the intervention. Computer measured time, readers score, and regions according to action and suspiciousness.~ClearRead CT Insight: During the second reading session (concurrent read), the radiologist was presented with a standard appearing CT with CADe marks placed and the vessel suppressed the same slice with the vessel suppressed view as the intervention. The second image, vessel suppressed, was not shown until the radiologist moved the mouse to the second panel. The radiologist again marked locations. These may or may not correspond to the locations of the CAD markers. As before, the radiologist then assigned a level of suspicious to each mark and indicate the need, if any, of an additional diagnostic action (CT Follow-up, Contrast CT, PET-CT, or Biopsy)."
11235101|NCT02440178|BG000|Baseline|Micafungin Prophylaxis|The baseline characteristics of total patients
11235102|NCT02440178|FG000|Participant Flow|Micafungin Prophylaxis|50 mg micafungin intravenously once daily from the initiation of induction chemotherapy to recovery of neutrophil count (absolute neutrophil count > 500/μg for three consecutive days), suspected fungal infection, or occurrence of drug-related toxicity
11235103|NCT02440178|OG000|Outcome|Micafungin Prophylaxis|The outcomes of fungal infections
11235104|NCT02440178|OG000|Outcome|Survival Outcome|The survival of patients till 12 weeks after induction chemotherapy
11235105|NCT02440178|OG000|Outcome|Non-relapse Mortality|Non-relapse mortality was defined as the incidence of death without a previous relapse or progression.
11235106|NCT02440178|EG000|Reported Event|Adverse Events|Serious adverse events: life-threatening adverse events Other adverse events: non-serious adverse events during treatment
11235107|NCT02440204|BG000|Baseline|Remifentanil 1.0 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235108|NCT02440204|BG001|Baseline|Remifentanil 1.5 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
10963897|NCT00874770|EG001|Reported Event|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11235109|NCT02440204|BG002|Baseline|Remifentanil 2.0 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235110|NCT02440204|BG003|Baseline|Total|Total of all reporting groups
11235111|NCT02440204|FG000|Participant Flow|Remifentanil 1.0 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11180732|NCT02063672|EG000|Reported Event|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
11180733|NCT02063672|EG001|Reported Event|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
11180734|NCT02063698|BG000|Baseline|Arm I (Auranofin)|Patients receive auranofin PO on day 2.
11180735|NCT02063698|BG001|Baseline|Arm II (Placebo)|Patients receive placebo PO on day 2.
11180736|NCT02063698|BG002|Baseline|Total|Total of all reporting groups
11180737|NCT02063698|FG000|Participant Flow|Arm I (Auranofin)|Patients receive auranofin PO on day 2.
11180738|NCT02063698|FG001|Participant Flow|Arm II (Placebo)|Patients receive placebo PO on day 2.
11180739|NCT02063698|OG000|Outcome|Arm I (Auranofin)|Patients receive auranofin PO on day 2.
11180740|NCT02063698|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO on day 2.
11180741|NCT02063698|EG000|Reported Event|Arm I (Auranofin)|Patients receive auranofin PO on day 2.
11180742|NCT02063698|EG001|Reported Event|Arm II (Placebo)|Patients receive placebo PO on day 2.
11180743|NCT02063737|BG000|Baseline|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
11180744|NCT02063737|BG001|Baseline|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
11180745|NCT02063737|BG002|Baseline|Total|Total of all reporting groups
11180746|NCT02063737|FG000|Participant Flow|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
11180747|NCT02063737|FG001|Participant Flow|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
11180748|NCT02063737|OG000|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
11180749|NCT02063737|OG001|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
11180750|NCT02063737|EG000|Reported Event|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
11180751|NCT02063737|EG001|Reported Event|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
11180752|NCT02063828|BG000|Baseline|Group A|"Group A - Device Guided Breathing Low Dose~Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks."
11180753|NCT02063828|BG001|Baseline|Group B|"Group B - Device guided breathing high dose~Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks."
11180754|NCT02063828|BG002|Baseline|Group C|"Group C - Usual Breathing Control Group~Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks."
11180755|NCT02063828|BG003|Baseline|Total|Total of all reporting groups
11180756|NCT02063828|FG000|Participant Flow|Group A - Device Guided Breathing Low Dose. 15 Minutes Once a Day, 5 Days a Week for 12 Weeks.|"Group A - Device Guided Breathing Low Dose~Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks."
11180757|NCT02063828|FG001|Participant Flow|Group B - Device Guided Breathing High Dose. 15 Minutes Twice a Day, 5 Days a Week for 12 Weeks.|"Group B - Device guided breathing high dose~Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks."
11180758|NCT02063828|FG002|Participant Flow|Group C - Usual Breathing Control Group. 15 Minutes Per Day, 5 Days a Week for 12 Weeks.|"Group C - Usual Breathing Control Group~Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks."
11180759|NCT02063828|OG000|Outcome|Group A|"Group A - Device Guided Breathing Low Dose~Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks."
11180760|NCT02063828|OG001|Outcome|Group B|"Group B - Device guided breathing high dose~Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks."
11180761|NCT02063828|OG002|Outcome|Group C|"Group C - Usual Breathing Control Group~Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks."
11180762|NCT02063828|EG000|Reported Event|Group A|"Group A - Device Guided Breathing Low Dose~Group A - Device guided breathing low dose: Group A: 15 minutes once a day, 5 days a week for 12 weeks."
11180763|NCT02063828|EG001|Reported Event|Group B|"Group B - Device guided breathing high dose~Group B - Device guided breathing high dose: Group B - 15 minutes twice a day, 5 days a week for 12 weeks."
11180764|NCT02063828|EG002|Reported Event|Group C|"Group C - Usual Breathing Control Group~Group C - Usual Breathing Control Group: Group C - 15 minutes per day, 5 days a week for 12 weeks."
11180765|NCT02063854|BG000|Baseline|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180766|NCT02063854|BG001|Baseline|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180767|NCT02063854|BG002|Baseline|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180768|NCT02063854|BG003|Baseline|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180769|NCT02063854|BG004|Baseline|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180770|NCT02063854|BG005|Baseline|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180771|NCT02063854|BG006|Baseline|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180772|NCT02063854|BG007|Baseline|Total|Total of all reporting groups
11180773|NCT02063854|FG000|Participant Flow|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180774|NCT02063854|FG001|Participant Flow|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11341790|NCT03688542|OG000|Outcome|Intervention|"Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy.~Quality Circle Deprescribing Module: The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus.."
11180775|NCT02063854|FG002|Participant Flow|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180776|NCT02063854|FG003|Participant Flow|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180777|NCT02063854|FG004|Participant Flow|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180778|NCT02063854|FG005|Participant Flow|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180779|NCT02063854|FG006|Participant Flow|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180780|NCT02063854|OG000|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180781|NCT02063854|OG001|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180782|NCT02063854|OG002|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180783|NCT02063854|OG001|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180784|NCT02063854|OG002|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180785|NCT02063854|OG003|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180786|NCT02063854|OG004|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180787|NCT02063854|OG005|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180788|NCT02063854|OG006|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
10963898|NCT00874770|EG002|Reported Event|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
11180789|NCT02063854|EG000|Reported Event|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180790|NCT02063854|EG001|Reported Event|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180791|NCT02063854|EG002|Reported Event|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180792|NCT02063854|EG003|Reported Event|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180793|NCT02063854|EG004|Reported Event|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180794|NCT02063854|EG005|Reported Event|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180795|NCT02063854|EG006|Reported Event|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11180796|NCT02063867|BG000|Baseline|Arm 1: Usual Care|Routine policy for showering or bathing non-critical care patients
11180797|NCT02063867|BG001|Baseline|Arm 2: Decolonization|"Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.~Arm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen."
11180798|NCT02063867|BG002|Baseline|Total|Total of all reporting groups
11180799|NCT02063867|FG000|Participant Flow|Arm 1: Usual Care|Routine policy for showering or bathing non-critical care patients
11180800|NCT02063867|FG001|Participant Flow|Arm 2: Decolonization|"Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.~Arm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen."
11180801|NCT02063867|OG000|Outcome|Arm 1: Usual Care|Routine policy for showering or bathing non-critical care patients
11180802|NCT02063867|OG001|Outcome|Arm 2: Decolonization|"Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.~Arm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen."
11180803|NCT02063867|EG000|Reported Event|Arm 1: Usual Care|Routine policy for showering or bathing non-critical care patients
11180804|NCT02063867|EG001|Reported Event|Arm 2: Decolonization|"Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.~Arm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen."
11180805|NCT02063880|BG000|Baseline|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
11341791|NCT03688542|OG001|Outcome|Control|Nursing Homes allocated to the Control arm will not enact the intervention.
11235112|NCT02440204|FG001|Participant Flow|Remifentanil 1.5 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235113|NCT02440204|FG002|Participant Flow|Remifentanil 2.0 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235114|NCT02440204|OG000|Outcome|Remifentanil 1.0 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235115|NCT02440204|OG001|Outcome|Remifentanil 1.5 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235116|NCT02440204|OG002|Outcome|Remifentanil 2.0 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235117|NCT02440204|EG000|Reported Event|Remifentanil 1.0 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235118|NCT02440204|EG001|Reported Event|Remifentanil 1.5 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235119|NCT02440204|EG002|Reported Event|Remifentanil 2.0 mcg/kg|"After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.~Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.~Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al."
11235120|NCT02440308|BG000|Baseline|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
11235121|NCT02440308|FG000|Participant Flow|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
11235122|NCT02440308|OG000|Outcome|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
11180806|NCT02063880|BG001|Baseline|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
11180807|NCT02063880|BG002|Baseline|Total|Total of all reporting groups
11180808|NCT02063880|FG000|Participant Flow|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
11180809|NCT02063880|FG001|Participant Flow|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
11180810|NCT02063880|OG000|Outcome|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
11180811|NCT02063880|OG001|Outcome|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
11180812|NCT02063880|EG000|Reported Event|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
11180813|NCT02063880|EG001|Reported Event|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
11180814|NCT02063984|BG000|Baseline|CM + WMT|Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
11180815|NCT02063984|BG001|Baseline|CM + No WMT|Intensive Outpatient Treatment + Contingency Management (IOP + CM)
11180816|NCT02063984|BG002|Baseline|Total|Total of all reporting groups
11180817|NCT02063984|FG000|Participant Flow|CM + WMT|Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
11180818|NCT02063984|FG001|Participant Flow|CM + No WMT|Intensive Outpatient Treatment + Contingency Management (IOP + CM)
11180819|NCT02063984|OG000|Outcome|CM + WMT|Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
11180820|NCT02063984|OG001|Outcome|CM + No WMT|Intensive Outpatient Treatment + Contingency Management (IOP + CM)
11180821|NCT02063984|OG000|Outcome|Strategy 1|Start in CM stay in CM
11180822|NCT02063984|OG001|Outcome|Strategy 2|Start in CM+WMT stay in CM+WMT
11180823|NCT02063984|OG002|Outcome|Strategy 3|Start in CM responders stay in CM, non-responders get Enhanced CM
11180824|NCT02063984|OG003|Outcome|Strategy 4|Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
11180825|NCT02063984|EG000|Reported Event|Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)|"IOP + CM + WMT~Intensive Outpatient Treatment (IOP) + Contingency Management (CM): Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives~Working Memory Training: 25 computer-delivered sessions of neurocognitive training"
11180826|NCT02063984|EG001|Reported Event|IOP + CM|"IOP + CM~Intensive Outpatient Treatment (IOP) + Contingency Management (CM): Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives"
11180827|NCT02064166|BG000|Baseline|Insulin|"40 IU of intranasal insulin daily~Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks."
11180828|NCT02064166|BG001|Baseline|Placebo|"Placebo arm using intranasal normal saline~Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks."
11180829|NCT02064166|BG002|Baseline|Total|Total of all reporting groups
11180830|NCT02064166|FG000|Participant Flow|Insulin|"Treatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily~Intranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;"
11180831|NCT02064166|FG001|Participant Flow|Placebo|"Placebo arm using intranasal normal saline~Placebo arm: normal saline, daily, intranasally, for 4 weeks."
11180832|NCT02064166|OG000|Outcome|Insulin Baseline|FAS score in the insulin group at baseline Treatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily Intranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;
11180833|NCT02064166|OG001|Outcome|Insulin Post Treatment|"FAS score in the insulin group post treatment~Treatment arm: 40 IU of intranasal human insulin Novolin R, Novo Nordisk daily Intranasal Insulin: Insulin, 40 IU of daily, intranasally, for 4 weeks;"
11180834|NCT02064166|OG002|Outcome|Placebo Baseline|"FAS score in the placebo group at baseline Placebo arm using intranasal normal saline~Placebo arm: normal saline, daily, intranasally, for 4 weeks."
11180835|NCT02064166|OG003|Outcome|Placebo Post Treatment|FAS score in the placebo group post treatment Placebo arm using intranasal normal saline Placebo arm: normal saline, daily, intranasally, for 4 weeks
11180836|NCT02064166|OG000|Outcome|Insulin Baseline|HY Scale in the insulin group at baseline
11180837|NCT02064166|OG001|Outcome|Insulin Post Treatment|HY scale in the insulin group post treatment
11180838|NCT02064166|OG002|Outcome|Placebo Baseline|HY scale in placebo group at baseline
11180839|NCT02064166|OG003|Outcome|Placebo Post Treatment|HY scale in placebo group post treatment
11180840|NCT02064166|OG000|Outcome|Insulin Baseline|MOCA Scale in insulin group at baseline
11180841|NCT02064166|OG001|Outcome|Insulin Post Treatment|MOCA scale in insulin group post treatment
11180842|NCT02064166|OG002|Outcome|Placebo Baseline|MOCA score in the placebo group at baseline
11180843|NCT02064166|OG003|Outcome|Placebo Post Treatment|MOCA score in the placebo group post treatment
11180844|NCT02064166|OG000|Outcome|Insulin Baseline|BDI Scale in the insulin group at baseline
11180845|NCT02064166|OG001|Outcome|Insulin Post Treatment|BDI scale in the insulin group post-treatment
11180846|NCT02064166|OG002|Outcome|Placebo Baseline|BDI score in the placebo group at baseline
11180847|NCT02064166|OG003|Outcome|Placebo Post Treatment|BDI score in the placebo group post treatment
11180848|NCT02064166|OG000|Outcome|Insulin Baseline|UPDRS III Scale in the insulin group at baseline
11180849|NCT02064166|OG001|Outcome|Insulin Post Treatment|UPDRS III Scale in the insulin group at post treatment
11180850|NCT02064166|OG002|Outcome|Placebo Baseline|UPDRS III Scale in the placebo group at baseline
11180851|NCT02064166|OG003|Outcome|Placebo Post Treatment|UPDRS III Scale in the insulin group post treatment
11180852|NCT02064166|OG000|Outcome|Insulin Baseline|Stride interval in the insulin group at baseline
11180853|NCT02064166|OG001|Outcome|Insulin Post Treatment|Stride interval in the insulin group post treatment
11180854|NCT02064166|OG002|Outcome|Placebo Baseline|Stride interval in placebo group at baseline
11180855|NCT02064166|OG003|Outcome|Placebo Post Treatment|Stride interval in placebo group post treatment
11180856|NCT02064166|EG000|Reported Event|Insulin|40 IU of intranasal insulin daily Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.
11180857|NCT02064166|EG001|Reported Event|Placebo|Placebo arm using intranasal normal saline Intranasal Insulin: 1.treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; 2. placebo arm: normal saline, daily, intranasally, for 4 weeks.
11180858|NCT02064205|BG000|Baseline|Overall Baseline Charactistics of 32 Slightly Overweight Women|Baseline data of the subjects were measured at screening at least one week before the start of the study.
11180859|NCT02064205|FG000|Participant Flow|All Study Participants|"A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min~Eight orders:~A-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B."
11180860|NCT02064205|OG000|Outcome|Polydextrose Syrup at Breakfast [A]|"Breakfast with pre-load four hours before lunch~12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch."
11180861|NCT02064205|OG001|Outcome|Glucose Syrup at Breakfast (Control) [B]|"Breakfast with control pre-load four hours before lunch~Yogurt with control (glucose syrup) is tested for its satiating effect.~glucose syrup: Glucose syrup is used a control product for the polydextrose"
11180862|NCT02064205|OG002|Outcome|Pre-load With Polydextroseglucose Before Lunch [C]|"Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.~12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch."
11180863|NCT02064205|OG003|Outcome|Pre-load With Yogurt and Glucose Before Lunch [D]|"Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.~Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch"
11180864|NCT02064205|OG000|Outcome|Polydextrose Syrup Preload With Yogurt With Breakfast [A]|Polydextrose syrup preload with yogurt with breakfast was consumed four hours before lunch
11180865|NCT02064205|OG001|Outcome|Glucose Syrup as Proload With Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
11180866|NCT02064205|OG002|Outcome|Pre-load With Polydextrose Before Lunch [C]|Pre-load with polydextrose syrup and yogurt is provided 1.5h before lunch
11180867|NCT02064205|OG003|Outcome|Pre-load With Glucose Syrup Before Lunch [D]|Pre-load with glucose syrup and yogurt was provided 1.5h before lunch.
11180868|NCT02064205|OG000|Outcome|Polydextrose Syrup at Breakfast [A]|Breakfast with polydextrose and yogurt provided four hours before lunch.
11180869|NCT02064205|OG001|Outcome|Glucose Syrup at Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
11180870|NCT02064205|EG000|Reported Event|Condition A|Breakfast with preload of yogurt and polydextrose
11180871|NCT02064205|EG001|Reported Event|Condition B|Breakfast with preload of yogurt and glucose control
11180872|NCT02064205|EG002|Reported Event|Condition C|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose
11180873|NCT02064205|EG003|Reported Event|Condition D|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup
11180874|NCT02064231|BG000|Baseline|Overall Study Population|
11180875|NCT02064231|FG000|Participant Flow|Coloplast Test A, Coloplast Test B, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days~Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
11180876|NCT02064231|FG001|Participant Flow|Coloplast Test C , Coloplast Test D, Own Product|"The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.~Coloplast Test C: Coloplast Test C is a new ostomy appliance developed by Coloplast A/S~Coloplast Test D: Coloplast Test D is a new ostomy appliance developed by Coloplast A/S"
11180877|NCT02064231|FG002|Participant Flow|Coloplast Test D, Coloplast Test C, Own Product|"The subjects first test Coloplast Test D and thereafter Coloplast Test C and finally their own product for 14 days~Coloplast Test D: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test C: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
11180878|NCT02064231|FG003|Participant Flow|Oloplast Test A, Coloplast Test D, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test D and finally their own product for 14 days~Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test D: Coloplast Test D is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
11180879|NCT02064231|OG000|Outcome|Coloplast Test A|Subjects testing Test A
11180880|NCT02064231|OG001|Outcome|Coloplast Test B|Subjects testing Test B
11180881|NCT02064231|OG002|Outcome|Coloplast Test C|Subjects testing Test C
11180882|NCT02064231|OG003|Outcome|Coloplast Test D|Subjects testing Test D
11180883|NCT02064231|OG004|Outcome|Own Product|Subjects collecting data on own product
11180884|NCT02064231|EG000|Reported Event|Coloplast Test A|Subjects testing Test A
11180885|NCT02064231|EG001|Reported Event|Coloplast Test B|Subjects testing Test B
11180886|NCT02064231|EG002|Reported Event|Coloplast Test C|Subjects testing Test C
11180887|NCT02064231|EG003|Reported Event|Coloplast Test D|Subjects testing Test D
11180888|NCT02064231|EG004|Reported Event|Own Product|Subjects collecting data on own product
11180889|NCT02064270|BG000|Baseline|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
11180890|NCT02064270|BG001|Baseline|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
11180891|NCT02064270|BG002|Baseline|Total|Total of all reporting groups
11180892|NCT02064270|FG000|Participant Flow|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
11180893|NCT02064270|FG001|Participant Flow|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
11180894|NCT02064270|OG000|Outcome|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
11180895|NCT02064270|OG001|Outcome|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
10961797|NCT00863057|BG002|Baseline|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
10961798|NCT00863057|BG003|Baseline|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
11180896|NCT02064270|EG000|Reported Event|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
11180897|NCT02064270|EG001|Reported Event|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
11180898|NCT02064439|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180899|NCT02064439|BG001|Baseline|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180900|NCT02064439|BG002|Baseline|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180901|NCT02064439|BG003|Baseline|Total|Total of all reporting groups
11180902|NCT02064439|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180903|NCT02064439|FG001|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180904|NCT02064439|FG002|Participant Flow|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180905|NCT02064439|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11235123|NCT02440308|EG000|Reported Event|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
10961799|NCT00863057|BG004|Baseline|Total|Total of all reporting groups
11180906|NCT02064439|OG001|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180907|NCT02064439|OG002|Outcome|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180908|NCT02064439|EG000|Reported Event|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180909|NCT02064439|EG001|Reported Event|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180910|NCT02064439|EG002|Reported Event|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
11180911|NCT02064582|BG000|Baseline|Enzalutamide, Leuprolide, Radiation|"Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care~Enzalutamide: 160mg by mouth each day~Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months~radiation: External beam radiation will be delivered as per standard radiation therapy protocol"
11180912|NCT02064582|FG000|Participant Flow|Enzalutamide, Leuprolide, Radiation|"Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care~Enzalutamide: 160mg by mouth each day~Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months~radiation: External beam radiation will be delivered as per standard radiation therapy protocol"
11180913|NCT02064582|OG000|Outcome|Enzalutamide, Leuprolide, Radiation|"Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care~Enzalutamide: 160mg by mouth each day~Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months~radiation: External beam radiation will be delivered as per standard radiation therapy protocol"
11180914|NCT02064582|EG000|Reported Event|Enzalutamide, Leuprolide, Radiation|"Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care~Enzalutamide: 160mg by mouth each day~Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months~radiation: External beam radiation will be delivered as per standard radiation therapy protocol"
11180915|NCT02064816|BG000|Baseline|Rebif Morning Administration|Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using RebiSmart autoinjector device in the morning for 12 weeks.
11180916|NCT02064816|BG001|Baseline|Rebif Evening Administration|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using RebiSmart autoinjector device in the evening for 12 weeks.
11180917|NCT02064816|BG002|Baseline|Total|Total of all reporting groups
11180918|NCT02064816|FG000|Participant Flow|Rebif Morning Administration|Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using RebiSmart autoinjector device in the morning for 12 weeks.
11180919|NCT02064816|FG001|Participant Flow|Rebif Evening Administration|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using RebiSmart autoinjector device in the evening for 12 weeks.
11180920|NCT02064816|OG000|Outcome|Rebif Morning Administration|Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using RebiSmart autoinjector device in the morning for 12 weeks.
11180921|NCT02064816|OG001|Outcome|Rebif Evening Administration|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using RebiSmart autoinjector device in the evening for 12 weeks.
11180922|NCT02064816|EG000|Reported Event|Rebif Morning Administration|Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using RebiSmart autoinjector device in the morning for 12 weeks.
11180923|NCT02064816|EG001|Reported Event|Rebif Evening Administration|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using RebiSmart autoinjector device in the evening for 12 weeks.
11180924|NCT02064855|BG000|Baseline|Demographics and Baseline Characteristics|Demographics and Baseline Characteristics (Patient Population)
11180925|NCT02064855|FG000|Participant Flow|EVEREST/VESUVIUS Demineralized Fibers|"This group involves patients treated with the VESUVIUS Demineralized Fibers and EVEREST system that had:~Diagnosis of spinal stenosis, spondylolisthesis (grade 1 or 2), and/or degenerative disc disease (DDD).~Qualified for inclusion by patient history and radiographic studies.~One or two contiguous levels requiring surgical intervention between L1-S1 Skeletally mature and greater than or equal to 18 years old at time of enrollment"
11180926|NCT02064855|OG000|Outcome|Up to Post Operative|AEs and SAEs that occurred at the beginning of the study up to Post Operative
10963899|NCT00874770|EG003|Reported Event|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
10963900|NCT00874822|BG000|Baseline|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
11180927|NCT02064855|OG001|Outcome|Post-Operative to 3 Months|AEs and SAEs that occurred at the beginning of the study from Post-Operative to 3 Months
11180928|NCT02064855|OG002|Outcome|3 to 6 Months|AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months
11180929|NCT02064855|OG003|Outcome|6 to 12 Months|AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months
11180930|NCT02064855|OG004|Outcome|12 to 24+ Months|AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months
11180931|NCT02064855|OG005|Outcome|Overall|Overall AEs and SAEs
11180932|NCT02064855|OG000|Outcome|Fusion Assessment|Fusion status of participants on CT assessed at 12 month visit
11180933|NCT02064855|OG000|Outcome|Graft Ratio|Radiographic Assessment of the fusion at 12 months
11180934|NCT02064855|OG001|Outcome|Instrumented Levels|Radiographic Assessment of the fusion at 12 months
11180935|NCT02064855|OG002|Outcome|Vertebrae Levels|Radiographic Assessment of the fusion at 12 months
11180936|NCT02064855|OG000|Outcome|Level 1|Radiographic assessments performed to determine Device Condition
11180937|NCT02064855|OG001|Outcome|Level 2: Superior|Radiographic assessments performed to determine Device Condition
11180938|NCT02064855|OG002|Outcome|Level 2: Inferior|Radiographic assessments performed to determine Device Condition
11180939|NCT02064855|OG000|Outcome|Pre-Operative|Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
11180940|NCT02064855|OG001|Outcome|Initial Post Operative|Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
11180941|NCT02064855|OG002|Outcome|3 Month|Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
11180942|NCT02064855|OG003|Outcome|6 Month|Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
11180943|NCT02064855|OG004|Outcome|12 Month|Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
11180944|NCT02064855|OG005|Outcome|24 Month|Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
11180945|NCT02064855|OG000|Outcome|Back|Change from baseline in pain scores on the Visual Analog Scale (VAS) at 24 months
11180946|NCT02064855|OG001|Outcome|Left Hip|Change from baseline in pain scores on the Visual Analog Scale (VAS) at 24 months
11180947|NCT02064855|OG002|Outcome|Right Hip|Change from baseline in pain scores on the Visual Analog Scale (VAS) at 24 months
11180948|NCT02064855|OG003|Outcome|Left Leg|Change from baseline in pain scores on the Visual Analog Scale (VAS) at 24 months
10847263|NCT00282438|FG000|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
11180949|NCT02064855|OG004|Outcome|Right Leg|Change from baseline in pain scores on the Visual Analog Scale (VAS) at 24 months
11180950|NCT02064855|OG000|Outcome|Mental Health|Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months
11180951|NCT02064855|OG001|Outcome|Physical Health|Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months
11180952|NCT02064855|OG000|Outcome|12 Month|Patient Satisfaction at 12 Mo
11180953|NCT02064855|OG001|Outcome|24 Month|Patient Satisfaction at 24 Mo
11180954|NCT02064855|OG000|Outcome|Surgery Time|Length of Surgery Time
11180955|NCT02064855|OG000|Outcome|Anesthesia Time|Length of Anesthesia Time
11180956|NCT02064855|OG000|Outcome|Estimated Blood Loss|The amount of blood loss over the entire length of the surgery will be captured.
11180957|NCT02064855|OG000|Outcome|Length of Hospital Stay|The length of Hospital Stay
11180958|NCT02064855|OG000|Outcome|Pre-Operative|Time to Return to Work/School
11180959|NCT02064855|OG001|Outcome|Initial Post Operative|Time to Return to Work/School
11180960|NCT02064855|OG002|Outcome|3 Month|Time to Return to Work/School
11180961|NCT02064855|OG003|Outcome|6 Month|Time to Return to Work/School
11180962|NCT02064855|OG004|Outcome|12 Month|Time to Return to Work/School
11180963|NCT02064855|OG005|Outcome|24 Month|Time to Return to Work/School
11180964|NCT02064855|OG000|Outcome|Pre-Operative|Use of Narcotics Post-surgery
11180965|NCT02064855|OG001|Outcome|Initial Post Operative|Use of Narcotics Post-surgery
11180966|NCT02064855|OG002|Outcome|3 Month|Use of Narcotics Post-surgery
11180967|NCT02064855|OG003|Outcome|6 Month|Use of Narcotics Post-surgery
11180968|NCT02064855|OG004|Outcome|12 Month|Use of Narcotics Post-surgery
11180969|NCT02064855|OG005|Outcome|24 Month|Use of Narcotics Post-surgery
11180970|NCT02064855|EG000|Reported Event|Participants With Adverse Events|"Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events.~3 of the 25 SAE participants did not experience a non-SAE events. The other 22 participants had events in both categories.~The study did not establish a frequency threshold, therefore, all AEs are listed."
11180971|NCT02064868|BG000|Baseline|Serelaxin + Standard of Care|Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
11180972|NCT02064868|BG001|Baseline|Standard of Care (SOC)|All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
11180973|NCT02064868|BG002|Baseline|Total|Total of all reporting groups
11180974|NCT02064868|FG000|Participant Flow|Serelaxin + Standard of Care|Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
11180975|NCT02064868|FG001|Participant Flow|Standard of Care (SOC)|All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
11180976|NCT02064868|OG000|Outcome|Serelaxin + Standard of Care|Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
11180977|NCT02064868|OG001|Outcome|Standard of Care (SOC)|All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
11180978|NCT02064868|EG000|Reported Event|Serelaxin + Standard of Care|Serelaxin (30 μg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
11180979|NCT02064868|EG001|Reported Event|Standard of Care (SOC)|All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
11180980|NCT02064894|BG000|Baseline|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
11180981|NCT02064894|BG001|Baseline|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
11180982|NCT02064894|BG002|Baseline|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
11180983|NCT02064894|BG003|Baseline|Total|Total of all reporting groups
11180984|NCT02064894|FG000|Participant Flow|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
11180985|NCT02064894|FG001|Participant Flow|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
11180986|NCT02064894|FG002|Participant Flow|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
11180987|NCT02064894|OG000|Outcome|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
10963901|NCT00874822|FG000|Participant Flow|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
11180988|NCT02064894|OG001|Outcome|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
11180989|NCT02064894|OG002|Outcome|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
11180990|NCT02064894|EG000|Reported Event|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
11180991|NCT02064894|EG001|Reported Event|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
11180992|NCT02064894|EG002|Reported Event|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
11180993|NCT02064907|BG000|Baseline|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
11180994|NCT02064907|BG001|Baseline|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
11180995|NCT02064907|BG002|Baseline|Total|Total of all reporting groups
11180996|NCT02064907|FG000|Participant Flow|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
11180997|NCT02064907|FG001|Participant Flow|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
11180998|NCT02064907|OG000|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
11180999|NCT02064907|OG001|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
11181000|NCT02064907|EG000|Reported Event|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
11181001|NCT02064907|EG001|Reported Event|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
11181002|NCT02064920|BG000|Baseline|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
11235124|NCT02440334|BG000|Baseline|Contrast Ultrasound Reccurence Screening|"Patients scheduled for MRI/CT follow up of a renal cancer previously treated by cryoablation therapy who will also undergo a contrast-enhanced ultrasound exam. This is a one-time imaging study and contrast ultrasound exams will be compared to the clinically scheduled MRI/CT.~Optison: Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature."
11235125|NCT02440334|FG000|Participant Flow|Contrast Ultrasound Reccurence Screening|"Patients scheduled for MRI/CT follow up of a renal cancer previously treated by cryoablation therapy who will also undergo a contrast-enhanced ultrasound exam. This is a one-time imaging study and contrast ultrasound exams will be compared to the clinically scheduled MRI/CT.~Optison: Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature."
11235126|NCT02440334|OG000|Outcome|Contrast Ultrasound Reccurence Screening|"Patients scheduled for MRI/CT follow up of a renal cancer previously treated by cryoablation therapy who will also undergo a contrast-enhanced ultrasound exam. This is a one-time imaging study and contrast ultrasound exams will be compared to the clinically scheduled MRI/CT.~Optison: Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature."
11235127|NCT02440334|EG000|Reported Event|Contrast Ultrasound Reccurence Screening|"Patients scheduled for MRI/CT follow up of a renal cancer previously treated by cryoablation therapy who will also undergo a contrast-enhanced ultrasound exam. This is a one-time imaging study and contrast ultrasound exams will be compared to the clinically scheduled MRI/CT.~Optison: Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature."
11235128|NCT02440451|BG000|Baseline|Neurofeedback Using BCI|"16 (13 + 3 in case of dropoffs) ASD subjects~Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session."
11235129|NCT02440451|FG000|Participant Flow|Neurofeedback Using BCI|"16 (13 + 3 in case of dropoffs) ASD subjects~Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session."
11235130|NCT02440451|OG000|Outcome|Neurofeedback Using BCI|"16 (13 + 3 in case of dropoffs) ASD subjects~Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session."
11235131|NCT02440451|EG000|Reported Event|Neurofeedback Using BCI|"16 (13 + 3 in case of dropoffs) ASD subjects~Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session."
11235132|NCT02440568|BG000|Baseline|Patients With Newly Diagnosed AML Cohort 1|"Patients will receive Omacetaxine 0.625mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine (at assigned dose level) administered subcutaneously Q12 hours Days 1 to 7. Dose levels include: 0.625, 1.25, 2.0, 3.0, and 4.2 mg/m^2~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235133|NCT02440568|BG001|Baseline|Patients With Newly Diagnosed AML Cohort 2|"Patients will receive Omacetaxine 1.25mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine (at assigned dose level) administered subcutaneously Q12 hours Days 1 to 7. Dose levels include: 0.625, 1.25, 2.0, 3.0, and 4.2 mg/m^2~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days."
11235134|NCT02440568|BG002|Baseline|Patients With Newly Diagnosed AML Cohort 3|"Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine (at assigned dose level) administered subcutaneously Q12 hours Days 1 to 7. Dose levels include: 0.625, 1.25, 2.0, 3.0, and 4.2 mg/m^2~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days."
10961800|NCT00863057|FG000|Participant Flow|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
10963902|NCT00874822|OG000|Outcome|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
11181003|NCT02064920|BG001|Baseline|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
11181004|NCT02064920|BG002|Baseline|Total|Total of all reporting groups
11181005|NCT02064920|FG000|Participant Flow|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
11181006|NCT02064920|FG001|Participant Flow|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
11181007|NCT02064920|OG000|Outcome|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
11181008|NCT02064920|OG001|Outcome|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
11181009|NCT02064920|EG000|Reported Event|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
11181010|NCT02064920|EG001|Reported Event|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
11181011|NCT02064959|BG000|Baseline|Normothermia|Control, temperature maintained at 37 degrees C
11181012|NCT02064959|BG001|Baseline|Hypothermia|treatment group, temperature at 35 degrees C at dura opening then 33 degrees C > 48 hours
11181013|NCT02064959|BG002|Baseline|Total|Total of all reporting groups
11181014|NCT02064959|FG000|Participant Flow|Normothermia|Control, temperature maintained at 37°C
11181015|NCT02064959|FG001|Participant Flow|Hypothermia|treatment group, temperature at 35°C at dura opening then 33°C > 48 hours
11181016|NCT02064959|OG000|Outcome|Normothermia|Control, temperature maintained at 37 degrees °C
10963903|NCT00874822|EG000|Reported Event|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
11181017|NCT02064959|OG001|Outcome|Hypothermia|treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C > 48 hours
11181018|NCT02064959|EG000|Reported Event|Normothermia|Control, temperature maintained at 37°C
11181019|NCT02064959|EG001|Reported Event|Hypothermia|treatment group, temperature at 35°C at dura opening then 33°C > 48 hours
11181020|NCT02064985|BG000|Baseline|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
11181021|NCT02064985|BG001|Baseline|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
11181022|NCT02064985|BG002|Baseline|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
11181023|NCT02064985|BG003|Baseline|Total|Total of all reporting groups
11181024|NCT02064985|FG000|Participant Flow|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
11181025|NCT02064985|FG001|Participant Flow|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
11181026|NCT02064985|FG002|Participant Flow|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
11181027|NCT02064985|OG000|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
11181028|NCT02064985|OG001|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
11181029|NCT02064985|OG002|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
11181030|NCT02064985|EG000|Reported Event|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
11181031|NCT02064985|EG001|Reported Event|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
11181032|NCT02064985|EG002|Reported Event|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
11181033|NCT02065245|BG000|Baseline|Pilot Phase - Group 1|"Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
10963904|NCT00874848|BG000|Baseline|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
11181034|NCT02065245|BG001|Baseline|Pilot Phase - Group 2|"Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181035|NCT02065245|BG002|Baseline|Pilot Phase - Group 3|"Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181036|NCT02065245|BG003|Baseline|Randomized Phase - Group A|"Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181037|NCT02065245|BG004|Baseline|Randomized Phase - Group B|"Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181038|NCT02065245|BG005|Baseline|Randomized Phase - Group C|"Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion~Placebo: Placebo administered by peripheral intravenous infusion."
11181039|NCT02065245|BG006|Baseline|Addendum B - Antibiotic Free Cell Group|"Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion~Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion."
11181040|NCT02065245|BG007|Baseline|Total|Total of all reporting groups
11181041|NCT02065245|FG000|Participant Flow|Pilot Phase - Group 1|"Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181042|NCT02065245|FG001|Participant Flow|Pilot Phase - Group 2|"Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181043|NCT02065245|FG002|Participant Flow|Pilot Phase - Group 3|"Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181044|NCT02065245|FG003|Participant Flow|Randomized Phase - Group A|"Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181045|NCT02065245|FG004|Participant Flow|Randomized Phase - Group B|"Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181046|NCT02065245|FG005|Participant Flow|Randomized Phase - Group C|"Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion~Placebo: Placebo administered by peripheral intravenous infusion."
11181047|NCT02065245|FG006|Participant Flow|Addendum B - Antibiotic Free Cell Group|"Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion~Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion."
11181048|NCT02065245|OG000|Outcome|Pilot Phase - Group 1|"Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
10963905|NCT00874848|BG001|Baseline|Control Arm|Cetuximab + Paclitaxel/Carboplatin
10963906|NCT00874848|BG002|Baseline|Total|Total of all reporting groups
11181049|NCT02065245|OG001|Outcome|Pilot Phase - Group 2|"Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181050|NCT02065245|OG002|Outcome|Pilot Phase - Group 3|"Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181051|NCT02065245|OG003|Outcome|Randomized Phase - Group A|"Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181052|NCT02065245|OG004|Outcome|Randomized Phase - Group B|"Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181053|NCT02065245|OG005|Outcome|Randomized Phase - Group C|"Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion~Placebo: Placebo administered by peripheral intravenous infusion."
11181054|NCT02065245|OG006|Outcome|Addendum B - Antibiotic Free Cell Group|"Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion~Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion."
11181055|NCT02065245|EG000|Reported Event|Pilot Phase - Group 1|"Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181056|NCT02065245|EG001|Reported Event|Pilot Phase - Group 2|"Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181057|NCT02065245|EG002|Reported Event|Pilot Phase - Group 3|"Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181058|NCT02065245|EG003|Reported Event|Randomized Phase - Group A|"Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181059|NCT02065245|EG004|Reported Event|Randomized Phase - Group B|"Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion"
11181060|NCT02065245|EG005|Reported Event|Randomized Phase - Group C|"Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion~Placebo: Placebo administered by peripheral intravenous infusion."
11181061|NCT02065245|EG006|Reported Event|Addendum B - Antibiotic Free Cell Group|"Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.~Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion~Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion."
11181062|NCT02065336|BG000|Baseline|ARC-520 Cohort 1|a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181063|NCT02065336|BG001|Baseline|ARC-520 Cohort 2|a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181064|NCT02065336|BG002|Baseline|ARC-520 Cohort 3|a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181065|NCT02065336|BG003|Baseline|ARC-520 Cohort 4|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181066|NCT02065336|BG004|Baseline|ARC-520 Cohort 5|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
11181067|NCT02065336|BG005|Baseline|ARC-520 Cohort 6|two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV
11181068|NCT02065336|BG006|Baseline|ARC-520 Cohort 7|a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB)
11181069|NCT02065336|BG007|Baseline|Placebo Normal Saline Cohorts 1-5|a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
11181070|NCT02065336|BG008|Baseline|Total|Total of all reporting groups
11181071|NCT02065336|FG000|Participant Flow|ARC-520 Cohort 1|a single intravenous (IV) dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181072|NCT02065336|FG001|Participant Flow|ARC-520 Cohort 2|a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181073|NCT02065336|FG002|Participant Flow|ARC-520 Cohort 3|a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181074|NCT02065336|FG003|Participant Flow|ARC-520 Cohort 4|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181075|NCT02065336|FG004|Participant Flow|ARC-520 Cohort 5|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
11181076|NCT02065336|FG005|Participant Flow|ARC-520 Cohort 6|two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV
11181077|NCT02065336|FG006|Participant Flow|ARC-520 Cohort 7|a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB)
11181078|NCT02065336|FG007|Participant Flow|Placebo Normal Saline Cohorts 1-5|a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
11181079|NCT02065336|FG008|Participant Flow|ARC-520 Cohort 9|open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
11181080|NCT02065336|FG009|Participant Flow|ARC-520 Cohort 10|open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
11181081|NCT02065336|OG000|Outcome|ARC-520 Cohort 1|a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181082|NCT02065336|OG001|Outcome|ARC-520 Cohort 2|a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181083|NCT02065336|OG002|Outcome|ARC-520 Cohort 3|a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181084|NCT02065336|OG003|Outcome|ARC-520 Cohort 4|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181085|NCT02065336|OG004|Outcome|ARC-520 Cohort 5|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
11181086|NCT02065336|OG005|Outcome|ARC-520 Cohort 6|two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV
11181087|NCT02065336|OG006|Outcome|ARC-520 Cohort 7|a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB)
11181088|NCT02065336|OG007|Outcome|Placebo Normal Saline Cohorts 1-5|a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
11181089|NCT02065336|OG008|Outcome|ARC-520 Cohort 9|open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
11181090|NCT02065336|OG009|Outcome|ARC-520 Cohort 10|open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
11181091|NCT02065336|OG006|Outcome|ARC-520 Cohort 7|a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
11181092|NCT02065336|OG007|Outcome|ARC-520 Cohort 9|open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
11181093|NCT02065336|OG008|Outcome|ARC-520 Cohort 10|open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
11181094|NCT02065336|OG009|Outcome|Placebo Normal Saline Cohorts 1-5|a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
11181095|NCT02065336|OG005|Outcome|ARC-520 Cohort 6|two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
11181096|NCT02065336|OG003|Outcome|ARC-520 Cohorts 4 and 5|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection or participants with HBeAg-positive immune active chronic HBV infection
11181097|NCT02065336|OG004|Outcome|ARC-520 Cohort 6|two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
11181098|NCT02065336|OG005|Outcome|ARC-520 Cohort 7|a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
11181099|NCT02065336|OG006|Outcome|Placebo Normal Saline Cohorts 1-5|a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
11181100|NCT02065336|EG000|Reported Event|ARC-520 Cohort 1|a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181101|NCT02065336|EG001|Reported Event|ARC-520 Cohort 2|a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181102|NCT02065336|EG002|Reported Event|ARC-520 Cohort 3|a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181103|NCT02065336|EG003|Reported Event|ARC-520 Cohort 4|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
11181104|NCT02065336|EG004|Reported Event|ARC-520 Cohort 5|a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
11181105|NCT02065336|EG005|Reported Event|ARC-520 Cohort 6|two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
11181106|NCT02065336|EG006|Reported Event|ARC-520 Cohort 7|a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
11181107|NCT02065336|EG007|Reported Event|ARC-520 Cohort 9|open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
11181108|NCT02065336|EG008|Reported Event|ARC-520 Cohort 10|open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
11181109|NCT02065336|EG009|Reported Event|Placebo Normal Saline Cohorts 1-5|a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
11181110|NCT02065453|BG000|Baseline|Disposable Device Left and Resusable Devices Right|27 women were randomized to receive disposable device left and resusable devices right
11181111|NCT02065453|BG001|Baseline|Disposable Device Right and Reusable Devices Left|25 women were randomized to receive disposable device right and reusable devices left
11181112|NCT02065453|BG002|Baseline|Total|Total of all reporting groups
11181113|NCT02065453|FG000|Participant Flow|Disposable Device - Left & Reusable Devices - Right|27 women were randomized to attending physicians using the disposable device on the left and reusable devices on the right.
11181114|NCT02065453|FG001|Participant Flow|Disposable Device - Right & Reusable Devices - Left|25 women were randomized to attending physicians using the disposable device on the right and reusable devices on the left
11181115|NCT02065453|OG000|Outcome|Disposable|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
11181116|NCT02065453|OG001|Outcome|Reusable|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
11181117|NCT02065453|EG000|Reported Event|Disposable or Reusable Energy Sources|Each patient serve as their own control. One side of the uterine attachments would be transected using the disposable device, the Ligasure, and the other using the two reusable devices, the Robi bipolar and Storz laparoscopic shears. It is our standard practice that the attending surgeon is on the patient's left side while the resident physician is on the patients right. To eliminate the bias of surgical experience, we will randomize the energy source used on each side for every case. Therefore, the number of cases performed by the attending surgeon with the disposable or reusable energy sources, will equal that of the less experienced resident surgeon.
11181118|NCT02065479|BG000|Baseline|Ticagrelor|"The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.~Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor"
11181119|NCT02065479|BG001|Baseline|Prasugrel|"The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.~Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor"
11181120|NCT02065479|BG002|Baseline|Total|Total of all reporting groups
11181121|NCT02065479|FG000|Participant Flow|Ticagrelor|"The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.~Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor"
11181122|NCT02065479|FG001|Participant Flow|Prasugrel|"The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.~Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor"
11181123|NCT02065479|OG000|Outcome|Ticagrelor|"The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.~Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor"
11181124|NCT02065479|OG001|Outcome|Prasugrel|"The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.~Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor"
11181125|NCT02065479|EG000|Reported Event|Ticagrelor|"The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.~Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor"
11181126|NCT02065479|EG001|Reported Event|Prasugrel|"The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.~Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor"
11181127|NCT02065518|BG000|Baseline|Standard Rehabilitation Protocol (SRP)|Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
11181128|NCT02065518|BG001|Baseline|NMES w/ SRP|"NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.~Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits."
11181129|NCT02065518|BG002|Baseline|Strength Walking w/ SRP|"Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.~Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks."
11181130|NCT02065518|BG003|Baseline|NMES/Strength Walking w/ SRP|NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
11181131|NCT02065518|BG004|Baseline|Total|Total of all reporting groups
11181132|NCT02065518|FG000|Participant Flow|Standard Rehabilitation Protocol (SRP)|Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
11181133|NCT02065518|FG001|Participant Flow|NMES w/ SRP|"NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.~Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits."
11181134|NCT02065518|FG002|Participant Flow|Strength Walking w/ SRP|"Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.~Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks."
11181135|NCT02065518|FG003|Participant Flow|NMES/Strength Walking w/ SRP|NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
11181136|NCT02065518|OG000|Outcome|Standard Rehabilitation Protocol (SRP)|Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
11181137|NCT02065518|OG001|Outcome|NMES w/ SRP|"NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.~Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits."
11181138|NCT02065518|OG002|Outcome|Strength Walking w/ SRP|"Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.~Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks."
11181139|NCT02065518|OG003|Outcome|NMES/Strength Walking w/ SRP|NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
11181140|NCT02065518|EG000|Reported Event|Standard Rehabilitation Protocol (SRP)|Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
11181141|NCT02065518|EG001|Reported Event|NMES w/ SRP|"NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.~Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits."
11181142|NCT02065518|EG002|Reported Event|Strength Walking w/ SRP|"Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.~Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks."
11181143|NCT02065518|EG003|Reported Event|NMES/Strength Walking w/ SRP|NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
11181144|NCT02065557|BG000|Baseline|Integrated Study (Main + Japan Sub- Study): I-SD|Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181145|NCT02065557|BG001|Baseline|Integrated Study (Main + Japan Sub- Study): I-HD|Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181146|NCT02065557|BG002|Baseline|Integrated Study (Main + Japan Sub- Study): I-HD-OL|(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181147|NCT02065557|BG003|Baseline|Total|Total of all reporting groups
11181148|NCT02065557|FG000|Participant Flow|Integrated Study: Induction Standard Dose (I-SD)|Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181149|NCT02065557|FG001|Participant Flow|Integrated Study: Induction High Dose (I-HD)|Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181150|NCT02065557|FG002|Participant Flow|Integrated Study: Induction High Dose Open Label (I-HD-OL)|(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181151|NCT02065557|FG003|Participant Flow|Integrated Study: Maintenance Placebo (M-PL)|(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
11181152|NCT02065557|FG004|Participant Flow|Integrated Study: Maintenance Standard Dose (M-SD)|Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg [maximum dose of 40 mg] every other week [eow]). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
11181153|NCT02065557|FG005|Participant Flow|Integrated Study: Maintenance High Dose (M-HD)|Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg [maximum dose of 40 mg] every week [ew]). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
11181154|NCT02065557|OG000|Outcome|Main Study: I-SD|Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181155|NCT02065557|OG001|Outcome|Main Study: I-HD|Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181156|NCT02065557|OG002|Outcome|Main Study: I-SD + I-HD|Combined I-SD + I-HD arms (see above).
11181157|NCT02065557|OG003|Outcome|Main Study: I-HD-OL|(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181158|NCT02065557|OG004|Outcome|Integrated Study (Main + Japan Sub-Study): I-SD|Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181159|NCT02065557|OG005|Outcome|Integrated Study (Main + Japan Sub-Study): I-HD|Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181160|NCT02065557|OG006|Outcome|Integrated Study (Main + Japan Sub-Study): I-SD + I-HD|Combined I-SD + I-HD arms (see above).
11181161|NCT02065557|OG007|Outcome|Integrated Study (Main + Japan Sub-Study): I-HD-OL|(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
11181162|NCT02065557|OG000|Outcome|Main Study: M-PL|(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
11181163|NCT02065557|OG001|Outcome|Main Study: M-SD|Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg [maximum dose of 40 mg] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
11181164|NCT02065557|OG002|Outcome|Main Study: M-HD|Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg [maximum dose of 40 mg] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
11181165|NCT02065557|OG003|Outcome|Main Study: M-SD + M-HD|Combined M-SD + M-HD arms (see above).
11181166|NCT02065557|OG004|Outcome|Integrated Study (Main + Japan Sub-Study): M-PL|(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
11181167|NCT02065557|OG005|Outcome|Integrated Study (Main + Japan Sub-Study): M-SD|Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg [maximum dose of 40 mg] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
11181168|NCT02065557|OG006|Outcome|Integrated Study (Main + Japan Sub-Study): M-HD|Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg [maximum dose of 40 mg] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
11181169|NCT02065557|OG007|Outcome|Integrated Study (Main + Japan Sub-Study): M-SD + M-HD|Combined M-SD + M-HD arms (see above).
11181170|NCT02065557|EG000|Reported Event|Integrated Study (Main + Japan Sub- Study): I-SD|"Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.~TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 52.8 days."
11181171|NCT02065557|EG001|Reported Event|Integrated Study (Main + Japan Sub- Study): I-HD|"Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.~TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.4 days."
11181172|NCT02065557|EG002|Reported Event|Integrated Study (Main + Japan Sub- Study): I-HD-OL|"(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.~TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 53.8 days."
11181173|NCT02065557|EG003|Reported Event|Integrated Study (Main + Japan Sub- Study): M-SD|"Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg [maximum dose of 40 mg] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.~TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 226.8 days."
11181174|NCT02065557|EG004|Reported Event|Integrated Study (Main + Japan Sub- Study): M-HD|"Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg [maximum dose of 40 mg] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.~TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 241.0 days."
11337336|NCT03582813|EG000|Reported Event|Self-directed Care|"Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods..~Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system"
11181175|NCT02065557|EG005|Reported Event|Integrated Study (Main + Japan Sub- Study): M-PL|"(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.~TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 184.2 days."
11181176|NCT02065557|EG006|Reported Event|Integrated Study (Main + Japan Sub- Study): Any Adalimumab|"Participants receiving any adalimumab during Induction or Maintenance Phase.~Any Adalimumab TEAEs: events with an onset date on or after first dose date of adalimumab and up to 70 days after the last dose date of adalimumab and prior to the first dose date in M10-870 if applicable, whichever comes first. For participants who received placebo during the maintenance period, TEAE collection period ends 70 days after last induction dose of adalimumab and re-starts with their next adalimumab dose, if applicable. Mean duration of treatment was 256.3 days."
11181177|NCT02065570|BG000|Baseline|Induction: Standard Induction Dose|Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.
11181178|NCT02065570|BG001|Baseline|Induction: Higher Induction Dose|Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
11181179|NCT02065570|BG002|Baseline|Total|Total of all reporting groups
11181180|NCT02065570|FG000|Participant Flow|Induction: Standard Induction Dose|Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.
11181181|NCT02065570|FG001|Participant Flow|Induction: Higher Induction Dose|Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
11181182|NCT02065570|FG002|Participant Flow|Maintenance: Clinically Adjusted (CA) Regimen|Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose could be escalated to every week (ew) starting as early as Week 14 and up to Week 54 based on Crohn's Disease Activity Index (CDAI) or high-sensitivity C-reactive protein (hs-CRP) values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.
11181183|NCT02065570|FG003|Participant Flow|Maintenance: Therapeutic Drug Monitoring (TDM) Regimen|At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
11181184|NCT02065570|OG000|Outcome|Induction: Standard Induction Dose|Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
11181185|NCT02065570|OG001|Outcome|Induction: Higher Induction Dose|Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
11181186|NCT02065570|OG000|Outcome|Induction: Standard Induction Dose|Participants were randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, and then matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.
11181187|NCT02065570|OG002|Outcome|Maintenance: Clinically Adjusted (CA) Regimen|Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.
11181188|NCT02065570|OG003|Outcome|Maintenance: Therapeutic Drug Monitoring (TDM) Regimen|At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
11181189|NCT02065570|EG000|Reported Event|Induction: Standard Induction Dose|Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
11181190|NCT02065570|EG001|Reported Event|Induction: Higher Induction Dose|Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
11181191|NCT02065570|EG002|Reported Event|Maintenance: Clinically Adjusted (CA) Regimen|Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.
11181192|NCT02065570|EG003|Reported Event|Maintenance: Therapeutic Drug Management (TDM) Regimen|At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
11181193|NCT02065622|BG000|Baseline|Induction (Main Study + Japan Sub-study): I-SD|Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.
11181194|NCT02065622|BG001|Baseline|Induction (Main Study + Japan Sub-study): I-HD|Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
11181195|NCT02065622|BG002|Baseline|Total|Total of all reporting groups
11181196|NCT02065622|FG000|Participant Flow|Induction (Main Study + Japan Sub-study): I-SD|Induction Standard Dose (I-SD): Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.
11181197|NCT02065622|FG001|Participant Flow|Induction (Main Study + Japan Sub-study): I-HD|Induction Higher Dose (I-HD): Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
11181198|NCT02065622|FG002|Participant Flow|Maintenance (Main Study + Japan Sub-study): M-SD|Maintenance Standard Dose (M-SD): Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.
11181199|NCT02065622|FG003|Participant Flow|Maintenance (Main Study + Japan Sub-study): M-HD|Maintenance Higher Dose (M-HD): Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
11181200|NCT02065622|FG004|Participant Flow|Maintenance (Main Study): TDM Regimen|Exploratory Therapeutic Drug Monitoring (TDM) Regimen: Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore assessments.
11181201|NCT02065622|OG000|Outcome|Induction (Main Study): I-SD|Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.
11181202|NCT02065622|OG001|Outcome|Induction (Main Study): I-HD|Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
11181203|NCT02065622|OG002|Outcome|Induction (Main Study + Japan Sub-study): I-SD|Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.
11181204|NCT02065622|OG003|Outcome|Induction (Main Study + Japan Sub-study): I-HD|Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
11181205|NCT02065622|OG000|Outcome|Maintenance (Main Study): M-SD|Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.
11181206|NCT02065622|OG001|Outcome|Maintenance (Main Study): M-HD|Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
11181207|NCT02065622|OG002|Outcome|Maintenance (Main Study + Japan Sub-study): M-SD|Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.
11181208|NCT02065622|OG003|Outcome|Maintenance (Main Study + Japan Sub-study): M-HD|Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
11181209|NCT02065622|EG000|Reported Event|Induction (Main Study + Japan Sub-study): I-SD|"Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.~TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 57.5 days."
11181210|NCT02065622|EG001|Reported Event|Induction (Main Study + Japan Sub-study): I-HD|"Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.~TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.0 days."
11181211|NCT02065622|EG002|Reported Event|Maintenance (Main Study + Japan Sub-study): M-SD|"Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.~TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 251.5 days."
11181212|NCT02065622|EG003|Reported Event|Maintenance (Main Study + Japan Sub-study): M-HD|"Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.~TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 263.1 days."
11181213|NCT02065622|EG004|Reported Event|Maintenance (Main Study): TDM Regimen|"Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments.~TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 255.9 days."
11181214|NCT02065687|BG000|Baseline|Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)|Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11337337|NCT03582813|EG001|Reported Event|Services as Usual|"Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers.~Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency"
11181215|NCT02065687|BG001|Baseline|Arm II (Paclitaxel, Carboplatin, Placebo)|Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11181216|NCT02065687|BG002|Baseline|Total|Total of all reporting groups
11181217|NCT02065687|FG000|Participant Flow|Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)|Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11181218|NCT02065687|FG001|Participant Flow|Arm II (Paclitaxel, Carboplatin, Placebo)|Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11181219|NCT02065687|OG000|Outcome|Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)|Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11181220|NCT02065687|OG001|Outcome|Arm II (Paclitaxel, Carboplatin, Placebo)|Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11181221|NCT02065687|EG000|Reported Event|Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)|Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11181222|NCT02065687|EG001|Reported Event|Arm II (Paclitaxel, Carboplatin, Placebo)|Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11181223|NCT02065713|BG000|Baseline|Golimumab in Combination With Methotrexate|"Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.~MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity~Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.~Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity"
11181224|NCT02065713|BG001|Baseline|Placebo in Combination With Methotrexate|"MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.~Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity~Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks."
11181225|NCT02065713|BG002|Baseline|Total|Total of all reporting groups
11181226|NCT02065713|FG000|Participant Flow|Placebo in Combination With Methotrexate|"Methotrexate (MTX) started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.~Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity~Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks."
11181227|NCT02065713|FG001|Participant Flow|Golimumab in Combination With Methotrexate|"Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.~MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity~Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.~Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity"
11337338|NCT03582826|BG000|Baseline|MEBO/PATM Cohort|"The cohort is 119 individuals who experienced symptoms of idiopathic malodor (MEBO: 70 participants) and/or PATM (people allergic to me condition: 39 participants)"
11337339|NCT03582826|BG001|Baseline|Non-MEBO/PATM Cohort|6 data volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
11337340|NCT03582826|BG002|Baseline|Total|Total of all reporting groups
11181228|NCT02065713|OG000|Outcome|Placebo in Combination With Methotrexate|"MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.~Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity~Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks."
11181229|NCT02065713|OG001|Outcome|Golimumab in Combination With Methotrexate|"Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.~MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity~Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.~Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity"
11181230|NCT02065713|EG000|Reported Event|Placebo in Combination With Methotrexate|"MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.~Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity~Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks."
11181231|NCT02065713|EG001|Reported Event|Golimumab in Combination With Methotrexate|"Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.~MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity~Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.~Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity"
11181232|NCT02065791|BG000|Baseline|Placebo|Participants received matching placebo orally once daily.
11181233|NCT02065791|BG001|Baseline|Canagliflozin 100 mg|Participants received canagliflozin 100 milligram (mg) orally once daily.
11181234|NCT02065791|BG002|Baseline|Total|Total of all reporting groups
11181235|NCT02065791|FG000|Participant Flow|Placebo|Participants received matching placebo orally once daily.
11181236|NCT02065791|FG001|Participant Flow|Canagliflozin 100 mg|Participants received canagliflozin 100 milligram (mg) orally once daily.
11181237|NCT02065791|OG000|Outcome|Placebo|Participants received matching placebo orally once daily.
11181238|NCT02065791|OG001|Outcome|Canagliflozin 100 mg|Participants received canagliflozin 100 milligram (mg) orally once daily.
11181239|NCT02065791|EG000|Reported Event|Placebo|Participants received matching placebo orally once daily.
11181240|NCT02065791|EG001|Reported Event|Canagliflozin 100 mg|Participants received canagliflozin 100 milligram (mg) orally once daily.
11181241|NCT02065895|BG000|Baseline|Closed-loop Control|Closed-loop control was performed from 9:00 PM to 2:00 the day following admission on three occasions: once with a glucose-value-used-for control calculated to be higher than the true blood glucose (analogous to a sensor glucose signal that is miss-calibrated); once with the value equal to blood glucose (analogous to a sensor signal with no calibration), and once with the value calculated to be lower than blood glucose. Six different arms were utilized, defined by the differing sequences of each of the three values used for control (no error, high error and low error previously defined). On each occasion control was separated into the nighttime period (midnight to 08:00 AM) and breakfast period (8:00 AM to 2:00 PM).
11181242|NCT02065895|FG000|Participant Flow|HIGH Error First, LOW Error Second, Then NO Error Third|In this arm, subjects were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose value (HIGH error), then second with the value calculated to be 20% lower than the true value (LOW error), then third with the value equal to the true value (NO error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
11181243|NCT02065895|FG001|Participant Flow|HIGH Error First, NO Error Second, Then LOW Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose value (HIGH error), then second with the value calculated to equal the true value (NO error), and then third with the value calculated to be 20% lower than the true value (LOW error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
11337341|NCT03582826|FG000|Participant Flow|MEBO/PATM Cohort|"The cohort is individuals who experienced symptoms of idiopathic malodor (MEBO) and/or PATM (people allergic to me condition)"
11337342|NCT03582826|FG001|Participant Flow|Non-MEBO/PATM Cohort|Individuals that never experienced MEBO or PATM symptoms that donated their gut microbiome samples
11337343|NCT03582826|OG000|Outcome|MEBO/PATM Cohort That Submitted Gut Samples|Participants who had experienced uncontrollable socially debilitating odor or PATM symptoms and submitted at least one gut sample for analysis (78 out of 119 in MEBO/PATM cohort)
11181244|NCT02065895|FG002|Participant Flow|NO Error First, LOW Error Second, HIGH Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control equal the true value (NO error), then second with the value calculated to be 20% lower than the true value (LOW error), and then third with the value calculated to be 33% higher than the true glucose value (HIGH error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
11181245|NCT02065895|FG003|Participant Flow|NO Error First, HIGH Error Second, LOW Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated equal the true value (NO error), and then second with the value calculated as 33% higher than the true glucose value (HIGH error), and then third with the value calculated to to be 20% lower than the true glucose value (LOW error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes).Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
11181246|NCT02065895|FG004|Participant Flow|LOW Error First, NO Error Second, HIGH Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated to be 20% lower than the true glucose value (LOW error), then second with the value calculated to equal the true value (NO error), and then third with the value calculated to be 33% higher than the true value. These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours,maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
11181247|NCT02065895|FG005|Participant Flow|LOW Error First, HIGH Error Second, NO Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated to be 20% lower than the true glucose value (LOW error), then second with the value calculated to be 33% higher than the true value (HIGH error), and then third with the value calculated to be equal the true value (NO error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
11181248|NCT02065895|OG000|Outcome|HIGH Error|Glucose sensor errors leading to sensor glucose reading higher than that true blood glucose result in closed-loop control systems (artificial pancreas) behaving as if the control gain is increased and the target is lowered. In this arm we study closed-loop control with a sensor signal reading 33% higher than blood glucose.
11181249|NCT02065895|OG001|Outcome|NO Error|Glucose sensor errors leading to sensor glucose reading higher than that true blood glucose result in closed-loop control systems (artificial pancreas) behaving as if the control gain is increased and the target is lowered. In this arm we study closed-loop control with a sensor signal reading equal to blood glucose.
11181250|NCT02065895|OG002|Outcome|LOW Error|Glucose sensor errors leading to sensor glucose reading higher than that true blood glucose result in closed-loop control systems (artificial pancreas) behaving as if the control gain is increased and the target is lowered. In this arm we study closed-loop control with a sensor signal reading 20% lower than blood glucose.
11181251|NCT02065895|OG000|Outcome|Gain Increased and Target Decreased|Closed-loop control performed with a sensor reading higher than blood glucose behave as if the control gain has been increased and the target set lowered
11181252|NCT02065895|OG001|Outcome|Nadir Mean|Closed-loop control performed with a sensor reading higher than blood glucose behave as if the control gain has been increased and the target set lowered
11181253|NCT02065895|OG002|Outcome|Gain Decreased and Target Increased|Closed-loop control performed with a sensor reading lower than blood glucose behave as if the control gain has been lowered and the target increased
11181254|NCT02065895|OG000|Outcome|HIGH Error|Closed-loop control performed with sensor glucose reading higher than blood glucose behaves as if the controller gain has been increased and the target lowered
11181255|NCT02065895|OG001|Outcome|NO Errror|Reference nighttime response for comparison with closed-loop control with sensor glucose reading higher than blood glucose and lower than blood glucose.
11181256|NCT02065895|OG002|Outcome|LOW Error|Closed-loop control performed with sensor glucose reading lower than blood glucose behaves as if the controller gain has been lowered and the target increased
11181257|NCT02065895|EG000|Reported Event|HIGH Error First, NO Error Second, LOW Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose (HIGH error), then with the value equal to the true glucose (NO error), and then with the value calculated to be 80% of the true value (LOW error).
11337344|NCT03582826|OG001|Outcome|Non-MEBO/PATM Cohort|Samples of volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
11337345|NCT03582826|OG000|Outcome|Subjects With Active MEBO/PATM|Individuals experiencing uncontrollable episodes of MEBO or PATM who submitted responses to Quality of Life (QoL) questionnaire.
11235135|NCT02440568|BG003|Baseline|Patients With Newly Diagnosed AML Cohort 4|"Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine (at assigned dose level) administered subcutaneously Q12 hours Days 1 to 7. Dose levels include: 0.625, 1.25, 2.0, 3.0, and 4.2 mg/m^2~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days."
11235136|NCT02440568|BG004|Baseline|Total|Total of all reporting groups
11235137|NCT02440568|FG000|Participant Flow|Patients With Newly Diagnosed AML, Cohort 1|"Patients will receive Omacetaxine 0.625mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235138|NCT02440568|FG001|Participant Flow|Patients With Newly Diagnosed AML, Cohort 2|"Patients will receive Omacetaxine 1.25mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235139|NCT02440568|FG002|Participant Flow|Patients With Newly Diagnosed AML, Cohort 3|"Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235140|NCT02440568|FG003|Participant Flow|Patients With Newly Diagnosed AML, Cohort 4|"Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235141|NCT02440568|OG000|Outcome|Patients With Newly Diagnosed AML, Cohort 1|"Patients will receive Omacetaxine 0.625mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235142|NCT02440568|OG001|Outcome|Patients With Newly Diagnosed AML, Cohort 2|"Patients will receive Omacetaxine 1.25mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235143|NCT02440568|OG002|Outcome|Patients With Newly Diagnosed AML, Cohort 3|"Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11337346|NCT03582826|OG001|Outcome|Subjects in Regression or Remission|Individuals self-describing themselves as being in remission or regression of MEBO/PATM (experiencing fewer and less severe flareups or disappearance of the symptoms) who submitted responses to QoL questionnaire.
11337347|NCT03582826|OG000|Outcome|Subjects With Active MEBO/PATM|Observations of individuals experiencing uncontrollable episodes of malodor or PATM
11235144|NCT02440568|OG003|Outcome|Patients With Newly Diagnosed AML, Cohort 4|"Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235145|NCT02440568|OG002|Outcome|Patients With Newly Diagnosed AML, Cohort 3|"Patients will receive Omacetaxine 2.0g/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235146|NCT02440568|EG000|Reported Event|Patients With Newly Diagnosed AML, Cohort 1|"Patients will receive Omacetaxine, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine at Dose level at 0.625mg/m^2 administered subcutaneously Q12 hours Days 1 to 7.~Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.~Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3."
11235147|NCT02440568|EG001|Reported Event|Patients With Newly Diagnosed AML, Cohort 2|"Patients will receive Omacetaxine, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine at Dose level at 1.25mg/m^2 administered"
11235148|NCT02440568|EG002|Reported Event|Patients With Newly Diagnosed AML, Cohort 3|"Patients will receive Omacetaxine, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine at Dose level at 2.0mg/m^2 administered"
11235149|NCT02440568|EG003|Reported Event|Patients With Newly Diagnosed AML, Cohort 4|"Patients will receive Omacetaxine, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event.~Omacetaxine at Dose level at 3.0mg/m^2 administered"
11235150|NCT02440594|BG000|Baseline|Enhanced Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235151|NCT02440594|BG001|Baseline|Standard Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235152|NCT02440594|BG002|Baseline|Enhanced Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/ BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.
11337348|NCT03582826|OG001|Outcome|Subjects in Regression or Remission|Observations of individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
11181258|NCT02065895|EG001|Reported Event|HIGH Error First, LOW Error Second, NO Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose (HIGH error), then with the value calculated to be 80% of the true value (LOW error), and then with the value equal to the true glucose (NO error).
11181259|NCT02065895|EG002|Reported Event|NO Error First, HIGH Error Second, LOW Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal to the true glucose (NO error), then with the value calculated to be 33% higher than the true glucose (HIGH error), and then with the value calculated to be 80% of the true value (LOW error).
11181260|NCT02065895|EG003|Reported Event|NO Error First, LOW Error Second, HIGH Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal to the true glucose (NO error), then with the value calculated to be 80% of the true value (LOW error) and then with the value calculated to be 33% higher than the true glucose (HIGH error)
11181261|NCT02065895|EG004|Reported Event|LOW Error First, NO Error Second, HIGH Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal 80% of the true value (LOW error), then with value equal to the true glucose (NO error), and then with the value calculated to be calculated to be 33% higher than the true glucose (HIGH error).
11181262|NCT02065895|EG005|Reported Event|LOW Error First, HIGH Error Second, NO Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 20% lower than the true glucose (LOW error), then with the value calculated to be 30% higher than the true value (HIGH error) and then with the value equal to the true glucose (NO error)
11181263|NCT02066051|BG000|Baseline|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
11181264|NCT02066051|FG000|Participant Flow|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
11181265|NCT02066051|OG000|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
11181266|NCT02066051|EG000|Reported Event|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
11181267|NCT02066129|BG000|Baseline|Fluticasone 44 mcg|"Fluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of yellow zone symptoms.~Fluticasone 44 mcg: Fluticasone is an inhaled corticosteroid"
11181268|NCT02066129|BG001|Baseline|Fluticasone 220 mcg|"Fluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of yellow zone symptoms.~Fluticasone 220 mcg: Fluticasone is an inhaled corticosteroid"
11181269|NCT02066129|BG002|Baseline|Total|Total of all reporting groups
11181270|NCT02066129|FG000|Participant Flow|Fluticasone 44 mcg|"Fluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of yellow zone symptoms.~Fluticasone 44 mcg: Fluticasone is an inhaled corticosteroid"
11181271|NCT02066129|FG001|Participant Flow|Fluticasone 220 mcg|"Fluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of yellow zone symptoms.~Fluticasone 220 mcg: Fluticasone is an inhaled corticosteroid"
11181272|NCT02066129|OG000|Outcome|Fluticasone 44 mcg|"Fluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of yellow zone symptoms.~Fluticasone 44 mcg: Fluticasone is an inhaled corticosteroid"
11181273|NCT02066129|OG001|Outcome|Fluticasone 220 mcg|"Fluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of yellow zone symptoms.~Fluticasone 220 mcg: Fluticasone is an inhaled corticosteroid"
11181274|NCT02066129|EG000|Reported Event|Fluticasone 44 mcg|"Fluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of yellow zone symptoms.~Fluticasone 44 mcg: Fluticasone is an inhaled corticosteroid"
11235153|NCT02440594|BG003|Baseline|Standard Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235154|NCT02440594|BG004|Baseline|Enhanced Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235155|NCT02440594|BG005|Baseline|Standard Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235156|NCT02440594|BG006|Baseline|Caregiver TEP Intervention|Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training.
11235157|NCT02440594|BG007|Baseline|Caregiver Control|Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services.
11235158|NCT02440594|BG008|Baseline|Total|Total of all reporting groups
11235159|NCT02440594|FG000|Participant Flow|Enhanced Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235160|NCT02440594|FG001|Participant Flow|Standard Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235161|NCT02440594|FG002|Participant Flow|Enhanced Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.
11235162|NCT02440594|FG003|Participant Flow|Standard Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11337349|NCT03582826|OG000|Outcome|MEBO/PATM Subcohort After Flare-up|study participants who experienced flare-ups of MEBO/PATM followed by improvements of their condition documented by corresponding gut samples and QoL questionnaire responses (22 out of 119 in MEBO/PATM cohort)
11337350|NCT03582826|OG001|Outcome|MEBO/PATM Subcohort After Improvement|same study participants who experienced improvement in MEBO/PATM status after flare-ups of this condition and submitted corresponding gut samples and QoL questionnaire responses to document their improvement (22 out of 119 in MEBO/PATM cohort)
11181275|NCT02066129|EG001|Reported Event|Fluticasone 220 mcg|"Fluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of yellow zone symptoms.~Fluticasone 220 mcg: Fluticasone is an inhaled corticosteroid"
11181276|NCT02066233|BG000|Baseline|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
11181277|NCT02066233|BG001|Baseline|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
11181278|NCT02066233|BG002|Baseline|Total|Total of all reporting groups
11181279|NCT02066233|FG000|Participant Flow|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
11181280|NCT02066233|FG001|Participant Flow|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
11181281|NCT02066233|OG000|Outcome|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
11181282|NCT02066233|OG001|Outcome|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
11181283|NCT02066233|EG000|Reported Event|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
11181284|NCT02066233|EG001|Reported Event|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
11181285|NCT02066298|BG000|Baseline|Mometasone Then Tiotropium Then Placebo|"Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181286|NCT02066298|BG001|Baseline|Mometasone Then Placebo Then Tiotropium|"Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181287|NCT02066298|BG002|Baseline|Placebo Then Mometasone Then Tiotropium|"Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181288|NCT02066298|BG003|Baseline|Placebo Then Tiotropium Then Mometasone|"Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181289|NCT02066298|BG004|Baseline|Tiotropium Then Placebo Then Mometasone|"Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181290|NCT02066298|BG005|Baseline|Tiotropium Then Mometasone Then Placebo|"Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181291|NCT02066298|BG006|Baseline|Total|Total of all reporting groups
11181292|NCT02066298|FG000|Participant Flow|Mometasone Then Tiotropium Then Placebo|"Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181293|NCT02066298|FG001|Participant Flow|Mometasone Then Placebo Then Tiotropium|"Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181294|NCT02066298|FG002|Participant Flow|Placebo Then Mometasone Then Tiotropium|"Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181295|NCT02066298|FG003|Participant Flow|Placebo Then Tiotropium Then Mometasone|"Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181296|NCT02066298|FG004|Participant Flow|Tiotropium Then Placebo Then Mometasone|"Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181297|NCT02066298|FG005|Participant Flow|Tiotropium Then Mometasone Then Placebo|"Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo~Mometasone 220mcg BID: Mometasone is an ICS~Tiotropium Respimat 5mcg QD: Tiotropium is a LMA~Placebo"
11181298|NCT02066298|OG000|Outcome|Eosinophil Low|Participants with sputum eosinophils < 2% at study entry
11181299|NCT02066298|OG001|Outcome|Eosinophil High|Participants with sputum eosinophils >= 2% at study entry
11181300|NCT02066298|OG000|Outcome|Placebo|The placebo treatment period for all participants.
11181301|NCT02066298|OG001|Outcome|Mometasone 220mcg BID|The mometasone treatment period for all participants. Mometasone administered 220mcg BID
11181302|NCT02066298|OG002|Outcome|Tiotropium Respimat 5mcg QD|The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD
11181303|NCT02066298|OG000|Outcome|Placebo|The placebo treatment period for all participants
11181304|NCT02066298|OG000|Outcome|Eosinophil Low - Placebo|The placebo treatment period for all participants
11181305|NCT02066298|EG000|Reported Event|Placebo|The placebo treatment period for all participants
11181306|NCT02066298|EG001|Reported Event|Mometasone 220mcg BID|The mometasone treatment period for all participants. Mometasone administered 220mcg BID
11181307|NCT02066298|EG002|Reported Event|Tiotropium Respimat 5mcg QD|The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD
11337351|NCT03582826|OG000|Outcome|Subjects With Active MEBO|Individuals experiencing uncontrollable episodes of malodor that did not self-diagnose PATM
11337352|NCT03582826|OG001|Outcome|Subjects With Active PATM|Individuals experiencing uncontrollable episodes of PATM with or without malodor
11181308|NCT02066311|BG000|Baseline|Open-label Study With the Simon Two-Stage Trial Design|"All subjects will be dosed with nelfinavir 750 mg orally three times daily. This dose may be decreased to 750 mg twice daily if not tolerated. For both stages of the trial the dosing period is 8 weeks followed by a 4 week observation period.~A maximum of 13 subjects will be enrolled in Stage 1. From the 13 subjects enrolled in Stage 1; if 3 or fewer subjects achieve a Response (a ≥35% reduction in serum anti-dsDNA antibody titer), the trial will be terminated. If 4 or more subjects achieve a Response, the study will be expanded to enroll an additional maximum of 30 patients in Stage 2."
11181309|NCT02066311|FG000|Participant Flow|Open-label Study With the Simon Two-Stage Trial Design|"All subjects will be dosed with nelfinavir 750 mg orally three times daily. This dose may be decreased to 750 mg twice daily if not tolerated. For both stages of the trial the dosing period is 8 weeks followed by a 4 week observation period.~A maximum of 13 subjects will be enrolled in Stage 1. From the 13 subjects enrolled in Stage 1; if 3 or fewer subjects achieve a Response (a ≥35% reduction in serum anti-dsDNA antibody titer), the trial will be terminated. If 4 or more subjects achieve a Response, the study will be expanded to enroll an additional maximum of 30 patients in Stage 2."
11181310|NCT02066311|OG000|Outcome|Open-label Study With the Simon Two-Stage Trial Design|"All subjects will be dosed with nelfinavir 750 mg orally three times daily. This dose may be decreased to 750 mg twice daily if not tolerated. For both stages of the trial the dosing period is 8 weeks followed by a 4 week observation period.~A maximum of 13 subjects will be enrolled in Stage 1. From the 13 subjects enrolled in Stage 1; if 3 or fewer subjects achieve a Response (a ≥35% reduction in serum anti-dsDNA antibody titer), the trial will be terminated. If 4 or more subjects achieve a Response, the study will be expanded to enroll an additional maximum of 30 patients in Stage 2."
11181311|NCT02066311|EG000|Reported Event|Open-label Study With the Simon Two-Stage Trial Design|"All subjects will be dosed with nelfinavir 750 mg orally three times daily. This dose may be decreased to 750 mg twice daily if not tolerated. For both stages of the trial the dosing period is 8 weeks followed by a 4 week observation period.~A maximum of 13 subjects will be enrolled in Stage 1. From the 13 subjects enrolled in Stage 1; if 3 or fewer subjects achieve a Response (a ≥35% reduction in serum anti-dsDNA antibody titer), the trial will be terminated. If 4 or more subjects achieve a Response, the study will be expanded to enroll an additional maximum of 30 patients in Stage 2."
11181312|NCT02066389|BG000|Baseline|Placebo|Participants received placebo capsules twice daily for 12 weeks.
11181313|NCT02066389|BG001|Baseline|Upadacitinib 3 mg BID|Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.
11181314|NCT02066389|BG002|Baseline|Upadacitinib 6 mg BID|Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.
11181315|NCT02066389|BG003|Baseline|Upadacitinib 12 mg BID|Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.
11181316|NCT02066389|BG004|Baseline|Upadacitinib 18 mg BID|Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.
11181317|NCT02066389|BG005|Baseline|Upadacitinib 24 mg QD|Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
11181318|NCT02066389|BG006|Baseline|Total|Total of all reporting groups
11181319|NCT02066389|FG000|Participant Flow|Placebo|Participants received placebo capsules twice daily for 12 weeks.
11181320|NCT02066389|FG001|Participant Flow|Upadacitinib 3 mg BID|Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.
11181321|NCT02066389|FG002|Participant Flow|Upadacitinib 6 mg BID|Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.
11181322|NCT02066389|FG003|Participant Flow|Upadacitinib 12 mg BID|Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.
11181323|NCT02066389|FG004|Participant Flow|Upadacitinib 18 mg BID|Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.
11181324|NCT02066389|FG005|Participant Flow|Upadacitinib 24 mg QD|Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
11181325|NCT02066389|OG000|Outcome|Placebo|Participants received placebo capsules twice daily for 12 weeks.
11181326|NCT02066389|OG001|Outcome|Upadacitinib 3 mg BID|Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.
11181327|NCT02066389|OG002|Outcome|Upadacitinib 6 mg BID|Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.
11181328|NCT02066389|OG003|Outcome|Upadacitinib 12 mg BID|Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.
11181329|NCT02066389|OG004|Outcome|Upadacitinib 18 mg BID|Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.
11181330|NCT02066389|OG005|Outcome|Upadacitinib 24 mg QD|Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
11181331|NCT02066389|EG000|Reported Event|Placebo|Participants received placebo capsules twice daily for 12 weeks.
11181332|NCT02066389|EG001|Reported Event|Upadacitinib 3 mg BID|Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.
11181333|NCT02066389|EG002|Reported Event|Upadacitinib 6 mg BID|Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.
11181334|NCT02066389|EG003|Reported Event|Upadacitinib 12 mg BID|Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.
11181335|NCT02066389|EG004|Reported Event|Upadacitinib 18 mg BID|Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.
11181336|NCT02066389|EG005|Reported Event|Upadacitinib 24 mg QD|Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
11181337|NCT02066402|BG000|Baseline|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
11181338|NCT02066402|BG001|Baseline|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
11181339|NCT02066402|BG002|Baseline|Total|Total of all reporting groups
11181340|NCT02066402|FG000|Participant Flow|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
11181341|NCT02066402|FG001|Participant Flow|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
11181342|NCT02066402|OG000|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
11235163|NCT02440594|FG004|Participant Flow|Enhanced Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235164|NCT02440594|FG005|Participant Flow|Standard Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235165|NCT02440594|FG006|Participant Flow|Caregiver TEP Intervention|Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training.
11235166|NCT02440594|FG007|Participant Flow|Caregiver Control|Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services.
11235167|NCT02440594|OG000|Outcome|Enhanced Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235168|NCT02440594|OG001|Outcome|Standard Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235169|NCT02440594|OG000|Outcome|Caregiver TEP Intervention|Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training.
11235170|NCT02440594|OG001|Outcome|Caregiver Control|Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services
11235171|NCT02440594|OG002|Outcome|Enhanced Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235172|NCT02440594|OG003|Outcome|Standard Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11337353|NCT03582826|OG002|Outcome|Subjects in Regression or Remission|Individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
11337354|NCT03582826|OG003|Outcome|Non MEBO/PATM Cohort|individuals that never experienced MEBO/PATM episodes
11337355|NCT03582826|EG000|Reported Event|Study Participants|"The cohort is individuals who consented to submit stool samples, including those who experienced symptoms of idiopathic malodor or PATM (people allergic to me condition) and received the support-group intervention."
11181343|NCT02066402|OG001|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
11181344|NCT02066402|EG000|Reported Event|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
11181345|NCT02066402|EG001|Reported Event|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
11181346|NCT02066467|BG000|Baseline|Heart Failure Patients|"Subjects with heart failure who receive stable optimal pharmacologic therapy~Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms~Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.~The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' .~Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment"
11181347|NCT02066467|FG000|Participant Flow|Heart Failure Patients|"Subjects with heart failure who receive stable optimal pharmacologic therapy~Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms~Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.~The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' .~Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment"
11181348|NCT02066467|OG000|Outcome|Heart Failure Patients|"Subjects with heart failure who receive stable optimal pharmacologic therapy~Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms~Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.~The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' .~Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment"
11181349|NCT02066467|EG000|Reported Event|Heart Failure Patients|"Subjects with heart failure who receive stable optimal pharmacologic therapy~Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms~Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.~The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' .~Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment"
11181350|NCT02066727|BG000|Baseline|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
11181351|NCT02066727|BG001|Baseline|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
11181352|NCT02066727|BG002|Baseline|Total|Total of all reporting groups
11181353|NCT02066727|FG000|Participant Flow|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
11181354|NCT02066727|FG001|Participant Flow|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
11181355|NCT02066727|OG000|Outcome|Normal Saline|"Normal Saline is administrated as an adjuvant of lidocaine.~Normal Saline: Normal Saline is administrated as an adjuvant of lidocaine."
11181356|NCT02066727|OG001|Outcome|Dexmedetomidine|"Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.~Dexmedetomidine: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg."
11181357|NCT02066727|EG000|Reported Event|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
11181358|NCT02066727|EG001|Reported Event|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
11181359|NCT02066740|BG000|Baseline|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
11181360|NCT02066740|FG000|Participant Flow|EverFlex™ Stent With Entrust™ Delivery System|Subjects were treated with the EverFlex™ stent with Entrust™ delivery system
11181361|NCT02066740|OG000|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
11181362|NCT02066740|EG000|Reported Event|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
11181363|NCT02066792|BG000|Baseline|Tailored Post-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). DCS will be administered if the session is deemed a success.~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181364|NCT02066792|BG001|Baseline|Pre-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181365|NCT02066792|BG002|Baseline|Placebo|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).~Placebo: Sugar pill"
11181366|NCT02066792|BG003|Baseline|Non-Tailored Post-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181367|NCT02066792|BG004|Baseline|Total|Total of all reporting groups
11181368|NCT02066792|FG000|Participant Flow|Tailored Post-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). Individuals are administered dcs after the session if exposure is determined successful (SUDS below 40). Individuals are administered the placebo is exposure is determined unsuccessful.~The type of pill (i.e. dcs vs. placebo) administered after session is determined after the session.~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181369|NCT02066792|FG001|Participant Flow|Pre-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181370|NCT02066792|FG002|Participant Flow|Placebo|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).~Placebo: Sugar pill"
11181371|NCT02066792|FG003|Participant Flow|Non-Tailored Post-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181372|NCT02066792|OG000|Outcome|Tailored Post-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). Individuals are administered dcs after the session if exposure is determined successful (SUDS below 40). Individuals are administered the placebo is exposure is determined unsuccessful.~The type of pill (i.e. dcs vs. placebo) administered after session is determined after the session.~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181373|NCT02066792|OG001|Outcome|Pre-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181374|NCT02066792|OG002|Outcome|Placebo|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).~Placebo: Sugar pill"
11181375|NCT02066792|OG003|Outcome|Non-Tailored Post-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181376|NCT02066792|EG000|Reported Event|Tailored Post-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). DCS will be administered if the session is deemed a success.~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181377|NCT02066792|EG001|Reported Event|Pre-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181378|NCT02066792|EG002|Reported Event|Placebo|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).~Placebo: Sugar pill"
11181379|NCT02066792|EG003|Reported Event|Non-Tailored Post-Session DCS|"Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).~D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.~Placebo: Sugar pill"
11181380|NCT02066857|BG000|Baseline|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
11181381|NCT02066857|BG001|Baseline|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
11181382|NCT02066857|BG002|Baseline|Total|Total of all reporting groups
11181383|NCT02066857|FG000|Participant Flow|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
11181384|NCT02066857|FG001|Participant Flow|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
11181385|NCT02066857|OG000|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
11181386|NCT02066857|OG001|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
11181387|NCT02066857|OG000|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
11181388|NCT02066857|EG000|Reported Event|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
11181389|NCT02066857|EG001|Reported Event|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
11181390|NCT02066896|BG000|Baseline|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
11181391|NCT02066896|BG001|Baseline|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
11181392|NCT02066896|BG002|Baseline|Total|Total of all reporting groups
11181393|NCT02066896|FG000|Participant Flow|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
11181394|NCT02066896|FG001|Participant Flow|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
11181395|NCT02066896|OG000|Outcome|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
11181396|NCT02066896|OG001|Outcome|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
11181397|NCT02066896|EG000|Reported Event|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
11181398|NCT02066896|EG001|Reported Event|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
11181399|NCT02066922|BG000|Baseline|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
11181400|NCT02066922|FG000|Participant Flow|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
11181401|NCT02066922|OG000|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
11181402|NCT02066922|OG001|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
11181403|NCT02066922|OG000|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
11181404|NCT02066922|EG000|Reported Event|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
11181405|NCT02066922|EG001|Reported Event|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
11181406|NCT02067000|BG000|Baseline|Obstructive Sleep Apnea|Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
11181407|NCT02067000|FG000|Participant Flow|Obstructive Sleep Apnea|Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
11181408|NCT02067000|OG000|Outcome|Obstructive Sleep Apnea|Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
11181409|NCT02067000|EG000|Reported Event|Obstructive Sleep Apnea|Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
11181410|NCT02067039|BG000|Baseline|HIV Self-testing|"The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.~OraQuick in home & Sure Check HIV tests: Provision of OraQuick in home & Sure Check HIV tests"
11181411|NCT02067039|BG001|Baseline|Information Only|All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
11181412|NCT02067039|BG002|Baseline|Total|Total of all reporting groups
11181413|NCT02067039|FG000|Participant Flow|Self-testing|"The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing. Participants had access to telephone consultation from study staff and a web-link to obtain HIV testing services in their community.~OraQuick in home & Sure Check HIV tests: Provision of OraQuick in home & Sure Check HIV tests"
11181414|NCT02067039|FG001|Participant Flow|Control|All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing. Participants had access to telephone consultation from study staff and a web-link to obtain HIV testing services in their community.
11181415|NCT02067039|OG000|Outcome|HIV Self-testing|"The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.~OraQuick in home & Sure Check HIV tests: Provision of OraQuick in home & Sure Check HIV tests"
11181416|NCT02067039|OG001|Outcome|Information Only|All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
11181417|NCT02067039|OG000|Outcome|Self-testing Social Network Associates (N=2150)|"The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing. Participants had access to telephone consultation from study staff and a web-link to obtain HIV testing services in their community.~OraQuick in home & Sure Check HIV tests: Provision of OraQuick in home & Sure Check HIV tests"
11181418|NCT02067039|OG001|Outcome|Control|Control group did not distribute HIV self-tests to social network members
11181419|NCT02067039|EG000|Reported Event|OraQuick in Home & Sure Check HIV Tests|"The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.~OraQuick in home & Sure Check HIV tests: Provision of OraQuick in home & Sure Check HIV tests"
11181420|NCT02067039|EG001|Reported Event|Information Only|All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
11181421|NCT02067273|BG000|Baseline|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
11181422|NCT02067273|BG001|Baseline|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
11181423|NCT02067273|BG002|Baseline|Total|Total of all reporting groups
11181424|NCT02067273|FG000|Participant Flow|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
11181425|NCT02067273|FG001|Participant Flow|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
11181426|NCT02067273|OG000|Outcome|TMS Intervention (1 Day)|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
11181427|NCT02067273|OG001|Outcome|TMS Intervention (5 Days)|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
11181428|NCT02067273|EG000|Reported Event|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
11181429|NCT02067273|EG001|Reported Event|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
11181430|NCT02067468|BG000|Baseline|COLPOSCOPY|"Women with ASC-US cytology are immediately referred to colposcopy~COLPOSCOPY: Colposcopy routine health services"
11181431|NCT02067468|BG001|Baseline|CYTOLOGY|"Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher~COLPOSCOPY: Colposcopy routine health services~cytology: Cytology routine health services"
11181432|NCT02067468|BG002|Baseline|HPV Test|"Women with ASC-US cytology are HPV tested and those HPV positive are referred to Colposcopy~HPV test: QIAGEN - The Digene HPV test®~COLPOSCOPY: Colposcopy routine health services"
11181433|NCT02067468|BG003|Baseline|Total|Total of all reporting groups
11181434|NCT02067468|FG000|Participant Flow|COLPOSCOPY|"Women with ASC-US cytology are immediately referred to colposcopy~COLPOSCOPY: Colposcopy routine health services"
11181435|NCT02067468|FG001|Participant Flow|CYTOLOGY|"Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher~COLPOSCOPY: Colposcopy routine health services~Cytology: Cytology routine health services"
11181436|NCT02067468|FG002|Participant Flow|HPV Test|"Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy~HPV test: QIAGEN - The Digene HPV test®~COLPOSCOPY: Colposcopy routine health services"
11181437|NCT02067468|OG000|Outcome|COLPOSCOPY|"Women with ASC-US cytology are immediately refer to colposcopy~COLPOSCOPY: Colposcopy routine health services"
11181438|NCT02067468|OG001|Outcome|CYTOLOGY|"Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher~COLPOSCOPY: Colposcopy routine health services~cytology: Cytology routine health services"
11181439|NCT02067468|OG002|Outcome|HPV Test|"Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy~HPV test: QIAGEN - The Digene HPV test®~COLPOSCOPY: Colposcopy routine health services"
11181440|NCT02067468|EG000|Reported Event|COLPOSCOPY|"Women with ASC-US cytology are immediately refer to colposcopy~COLPOSCOPY: Colposcopy routine health services"
11181441|NCT02067468|EG001|Reported Event|CYTOLOGY|"Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher~COLPOSCOPY: Colposcopy routine health services~cytology: Cytology routine health services"
11181442|NCT02067468|EG002|Reported Event|HPV Test|"Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy~HPV test: QIAGEN - The Digene HPV test®~COLPOSCOPY: Colposcopy routine health services"
11181443|NCT02067533|BG000|Baseline|Flexion Position|soft tissue repair in flexion position
11181444|NCT02067533|BG001|Baseline|Extension Position|soft tissue repair in extension position
11181445|NCT02067533|BG002|Baseline|Total|Total of all reporting groups
11181446|NCT02067533|FG000|Participant Flow|Flexion Position|soft tissue repair in flexion position
11181447|NCT02067533|FG001|Participant Flow|Extension Position|soft tissue repair in extension position
11181448|NCT02067533|OG000|Outcome|Flexion Position|soft tissue repair in flexion position
11181449|NCT02067533|OG001|Outcome|Extension Position|soft tissue repair in extension position
11181450|NCT02067533|EG000|Reported Event|Flexion Position|soft tissue repair in flexion position
11181451|NCT02067533|EG001|Reported Event|Extension Position|soft tissue repair in extension position
11181452|NCT02067585|BG000|Baseline|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181453|NCT02067585|BG001|Baseline|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181454|NCT02067585|BG002|Baseline|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181455|NCT02067585|BG003|Baseline|Total|Total of all reporting groups
11181456|NCT02067585|FG000|Participant Flow|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181457|NCT02067585|FG001|Participant Flow|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181458|NCT02067585|FG002|Participant Flow|Control|no-operated
11181459|NCT02067585|OG000|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181460|NCT02067585|OG001|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181461|NCT02067585|OG002|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181462|NCT02067585|EG000|Reported Event|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181463|NCT02067585|EG001|Reported Event|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181464|NCT02067585|EG002|Reported Event|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
11181465|NCT02067663|BG000|Baseline|Mirena Group|"Women who have a postplacental Mirena IUD placed. (LNG-IUS)~Mirena: The IUD will be placed as part of standard clinical care."
11181466|NCT02067663|BG001|Baseline|Paragard Group|"Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)~Paragard: The IUD will be placed as part of standard clinical care."
11181467|NCT02067663|BG002|Baseline|Total|Total of all reporting groups
11181468|NCT02067663|FG000|Participant Flow|Mirena Group|"Women who have a postplacental Mirena IUD placed. (LNG-IUS)~Mirena: The IUD will be placed as part of standard clinical care."
11181469|NCT02067663|FG001|Participant Flow|Paragard Group|"Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)~Paragard: The IUD will be placed as part of standard clinical care."
11181470|NCT02067663|OG000|Outcome|Mirena Group|"Women who have a postplacental Mirena IUD placed. (LNG-IUS)~Mirena: The IUD will be placed as part of standard clinical care."
11181471|NCT02067663|OG001|Outcome|Paragard Group|"Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)~Paragard: The IUD will be placed as part of standard clinical care."
11181472|NCT02067663|EG000|Reported Event|Mirena Group|"Women who have a postplacental Mirena IUD placed. (LNG-IUS)~Mirena: The IUD will be placed as part of standard clinical care."
11181473|NCT02067663|EG001|Reported Event|Paragard Group|"Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)~Paragard: The IUD will be placed as part of standard clinical care."
11181474|NCT02067676|BG000|Baseline|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181475|NCT02067676|BG001|Baseline|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181476|NCT02067676|BG002|Baseline|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181477|NCT02067676|BG003|Baseline|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181478|NCT02067676|BG004|Baseline|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181479|NCT02067676|BG005|Baseline|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181480|NCT02067676|BG006|Baseline|Total|Total of all reporting groups
11181481|NCT02067676|FG000|Participant Flow|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181482|NCT02067676|FG001|Participant Flow|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181483|NCT02067676|FG002|Participant Flow|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181484|NCT02067676|FG003|Participant Flow|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181485|NCT02067676|FG004|Participant Flow|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181486|NCT02067676|FG005|Participant Flow|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181487|NCT02067676|OG000|Outcome|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181488|NCT02067676|OG001|Outcome|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181489|NCT02067676|OG002|Outcome|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181490|NCT02067676|OG003|Outcome|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181491|NCT02067676|OG004|Outcome|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181492|NCT02067676|OG005|Outcome|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181493|NCT02067676|OG000|Outcome|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181494|NCT02067676|OG001|Outcome|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181495|NCT02067676|OG002|Outcome|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181496|NCT02067676|OG003|Outcome|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181497|NCT02067676|OG004|Outcome|CJCV1 10 μg / Alum 0 μg (3A)|Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum) CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
11181498|NCT02067676|EG000|Reported Event|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181499|NCT02067676|EG001|Reported Event|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181500|NCT02067676|EG002|Reported Event|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181501|NCT02067676|EG003|Reported Event|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181502|NCT02067676|EG004|Reported Event|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
11181503|NCT02067676|EG005|Reported Event|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
11181504|NCT02067728|BG000|Baseline|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
11181505|NCT02067728|BG001|Baseline|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
11181506|NCT02067728|BG002|Baseline|Total|Total of all reporting groups
11181507|NCT02067728|FG000|Participant Flow|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
11181508|NCT02067728|FG001|Participant Flow|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
11181509|NCT02067728|OG000|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
11181510|NCT02067728|OG001|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
11181511|NCT02067728|EG000|Reported Event|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
11181512|NCT02067728|EG001|Reported Event|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
11181513|NCT02067806|BG000|Baseline|Chloroprocaine 1%|intrathecal anesthesia with 1% solution of 2-chloroprocaine hydrochloride in patients undergoing short surgical procedures (max. 40 minutes).
11181514|NCT02067806|FG000|Participant Flow|Chloroprocaine 1%|Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
11181515|NCT02067806|OG000|Outcome|Chloroprocaine 1%|Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
11181516|NCT02067806|OG000|Outcome|Chloroprocaine 1%|intrathecal anesthesia with 1% solution of 2-chloroprocaine hydrochloride in patients undergoing short surgical procedures (max. 40 minutes).
11181517|NCT02067806|EG000|Reported Event|Chloroprocaine 1%|Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
11181518|NCT02067858|BG000|Baseline|Stereotactic Radiosurgery|"3 fractions x 20 Gy 4 fractions x 12 Gy~Lesion dependent~Stereotactic Radiosurgery"
11181519|NCT02067858|FG000|Participant Flow|Stereotactic Radiosurgery|"3 fractions x 20 Gy 4 fractions x 12 Gy~Lesion dependent~Stereotactic Radiosurgery"
11181520|NCT02067858|OG000|Outcome|Stereotactic Radiosurgery|"3 fractions x 20 Gy 4 fractions x 12 Gy~Lesion dependent~Stereotactic Radiosurgery"
11181521|NCT02067858|EG000|Reported Event|Stereotactic Radiosurgery|"3 fractions x 20 Gy 4 fractions x 12 Gy~Lesion dependent~Stereotactic Radiosurgery"
11181522|NCT02068027|BG000|Baseline|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
11181523|NCT02068027|BG001|Baseline|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
11181524|NCT02068027|BG002|Baseline|Total|Total of all reporting groups
11181525|NCT02068027|FG000|Participant Flow|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
11181526|NCT02068027|FG001|Participant Flow|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
11181527|NCT02068027|OG000|Outcome|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
11181528|NCT02068027|OG001|Outcome|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
11181529|NCT02068027|EG000|Reported Event|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
11181530|NCT02068027|EG001|Reported Event|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
10847264|NCT00282438|FG001|Participant Flow|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
11181531|NCT02068118|BG000|Baseline|Standard Care|Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
11181532|NCT02068118|BG001|Baseline|Tele-cardiology Group|"The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.~Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure."
11181533|NCT02068118|BG002|Baseline|Total|Total of all reporting groups
11181534|NCT02068118|FG000|Participant Flow|Standard Care|"Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.~Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period."
11181535|NCT02068118|FG001|Participant Flow|Tele-cardiology Group|"Device: Telecardiology Program~- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.~Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.~- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period."
11181536|NCT02068118|OG000|Outcome|Standard Care|Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
11181537|NCT02068118|OG001|Outcome|Tele-cardiology Group|"The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.~Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure."
11181538|NCT02068118|OG000|Outcome|Standard Care/Tele-cardiology|"Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.~Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period."
11181539|NCT02068118|OG001|Outcome|Tele-cardiology/Tele-cardiology|"- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.~Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.~- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period."
11181540|NCT02068118|EG000|Reported Event|Standard Care/Tele-cardiology|"Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.~Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period."
11181541|NCT02068118|EG001|Reported Event|Tele-cardiology Group/Tele-cardiology|"- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.~Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.~- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period."
11235173|NCT02440594|OG004|Outcome|Enhanced Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.
11235174|NCT02440594|OG005|Outcome|Standard Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235175|NCT02440594|OG003|Outcome|Standard Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues
11235176|NCT02440594|OG000|Outcome|Enhanced Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.
11235177|NCT02440594|OG001|Outcome|Standard Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235178|NCT02440594|OG002|Outcome|Enhanced Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235179|NCT02440594|OG003|Outcome|Standard Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235180|NCT02440594|OG004|Outcome|Enhanced Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235181|NCT02440594|OG005|Outcome|Standard Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11181542|NCT02068157|BG000|Baseline|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
11181543|NCT02068157|FG000|Participant Flow|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
11181544|NCT02068157|OG000|Outcome|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
11181545|NCT02068157|EG000|Reported Event|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
11181546|NCT02068222|BG000|Baseline|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
11181547|NCT02068222|FG000|Participant Flow|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
11181548|NCT02068222|OG000|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
11181549|NCT02068222|EG000|Reported Event|ABT-450/r and ABT-530 Plus RBV|ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
11181550|NCT02068352|BG000|Baseline|0.3% OPA-15406|OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181551|NCT02068352|BG001|Baseline|1% OPA-15406|OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181552|NCT02068352|BG002|Baseline|Vehicle Ointment|OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181553|NCT02068352|BG003|Baseline|Total|Total of all reporting groups
11181554|NCT02068352|FG000|Participant Flow|0.3% OPA-15406|OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181555|NCT02068352|FG001|Participant Flow|1% OPA-15406|OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181556|NCT02068352|FG002|Participant Flow|Vehicle Ointment|OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181557|NCT02068352|OG000|Outcome|0.3% OPA-15406|OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181558|NCT02068352|OG001|Outcome|1% OPA-15406|OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181559|NCT02068352|OG002|Outcome|Vehicle Ointment|OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181560|NCT02068352|EG000|Reported Event|0.3% OPA-15406|OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181561|NCT02068352|EG001|Reported Event|1% OPA-15406|OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181562|NCT02068352|EG002|Reported Event|Vehicle Ointment|OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
11181563|NCT02068443|BG000|Baseline|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
11181564|NCT02068443|BG001|Baseline|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
11181565|NCT02068443|BG002|Baseline|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
11181566|NCT02068443|BG003|Baseline|Total|Total of all reporting groups
11181567|NCT02068443|FG000|Participant Flow|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
11181568|NCT02068443|FG001|Participant Flow|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
11181569|NCT02068443|FG002|Participant Flow|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
11181570|NCT02068443|OG000|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
11181571|NCT02068443|OG001|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
11181572|NCT02068443|OG002|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
11181573|NCT02068443|EG000|Reported Event|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
11181574|NCT02068443|EG001|Reported Event|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
11181575|NCT02068443|EG002|Reported Event|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
11181576|NCT02068495|BG000|Baseline|Candesartan Cilexetil/Amlodipine|Candesartan cilexetil/Amlodipine 8 mg/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11181577|NCT02068495|FG000|Participant Flow|Candesartan Cilexetil/Amlodipine|Candesartan cilexetil/Amlodipine 8 mg/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11181578|NCT02068495|OG000|Outcome|Candesartan Cilexetil/Amlodipine|Candesartan cilexetil/Amlodipine 8 mg/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11181579|NCT02068495|EG000|Reported Event|Candesartan Cilexetil/Amlodipine|Candesartan cilexetil/Amlodipine 8 mg/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11181580|NCT02068508|BG000|Baseline|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11181581|NCT02068508|FG000|Participant Flow|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11181582|NCT02068508|OG000|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11181583|NCT02068508|EG000|Reported Event|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11181584|NCT02068599|BG000|Baseline|TV-45070 4%|TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181585|NCT02068599|BG001|Baseline|TV-45070 8%|TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181586|NCT02068599|BG002|Baseline|Placebo|Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181587|NCT02068599|BG003|Baseline|Total|Total of all reporting groups
11181588|NCT02068599|FG000|Participant Flow|TV-45070 4%|TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181589|NCT02068599|FG001|Participant Flow|TV-45070 8%|TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181590|NCT02068599|FG002|Participant Flow|Placebo|Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181591|NCT02068599|OG000|Outcome|TV-45070 4%|TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181592|NCT02068599|OG001|Outcome|TV-45070 8%|TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181593|NCT02068599|OG002|Outcome|Placebo|Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181594|NCT02068599|EG000|Reported Event|TV-45070 4%|TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181595|NCT02068599|EG001|Reported Event|TV-45070 8%|TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181596|NCT02068599|EG002|Reported Event|Placebo|Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
11181597|NCT02068729|BG000|Baseline|Demographics and Baseline Characteristics|This is a demographic and baseline characteristics of the patient population. This includes parameters such as Age, Gender, Height, Weight Body Mass Index (BMI) and Tobacco Usage.
11181598|NCT02068729|FG000|Participant Flow|K2M RAVINE Lateral Access System|"This treatment group included patients treated with the RAVINE system that had:~A diagnosis of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1, confirmed clinically and radiographically, required surgical intervention.~One or two contiguous levels that required surgical intervention.~Inadequately responded to conservative medical care over a period of at least 6 months.~An age at time of enrollment greater or equal to 18 years old."
11181599|NCT02068729|OG000|Outcome|Back|Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.
11181600|NCT02068729|OG001|Outcome|Left Hip|Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.
11181601|NCT02068729|OG002|Outcome|Right Hip|Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.
11181602|NCT02068729|OG003|Outcome|Left Leg|Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.
11181603|NCT02068729|OG004|Outcome|Right Leg|Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.
11181604|NCT02068729|OG000|Outcome|Up to Post-Operative|Number of Patients with Adverse Events up to Post-Operative
11181605|NCT02068729|OG001|Outcome|Post-Operative to 3 Months|Number of Patients with Adverse Events Post-Operative to 3 Months
11181606|NCT02068729|OG002|Outcome|3 to 6 Months|Number of Patients with Adverse Events 3 to 6 Months
11181607|NCT02068729|OG003|Outcome|6 to 12 Months|Number of Patients with Adverse Events 6 to 12 Months
11181608|NCT02068729|OG004|Outcome|12 to 24+ Months|Number of Patients with Adverse Events 12 to 24+ Months
11181609|NCT02068729|OG005|Outcome|Overall|Overall number of Patients with Adverse Events
11181610|NCT02068729|OG000|Outcome|Discharge|Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness
11181611|NCT02068729|OG001|Outcome|Post-Operative|Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness
11181612|NCT02068729|OG002|Outcome|3 Months|Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness
11181613|NCT02068729|OG003|Outcome|6 Months|Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness
11181614|NCT02068729|OG004|Outcome|12 Months|Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness
11181615|NCT02068729|OG005|Outcome|24 Months|Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness
11181616|NCT02068729|OG000|Outcome|Discharge|Change in Oswestry Disability Index
11181617|NCT02068729|OG001|Outcome|Post-Operative|Change in Oswestry Disability Index
11181618|NCT02068729|OG002|Outcome|3 Months|Change in Oswestry Disability Index
11181619|NCT02068729|OG003|Outcome|6 Months|Change in Oswestry Disability Index
11181620|NCT02068729|OG004|Outcome|12 Months|Change in Oswestry Disability Index
11181621|NCT02068729|OG005|Outcome|24 Months|Change in Oswestry Disability Index
11181622|NCT02068729|OG000|Outcome|Discharge|Change in Health-Related Quality of Life From Baseline
11181623|NCT02068729|OG001|Outcome|Post-Operative|Change in Health-Related Quality of Life From Baseline
11181624|NCT02068729|OG002|Outcome|3 Months|Change in Health-Related Quality of Life From Baseline
11181625|NCT02068729|OG003|Outcome|6 Months|Change in Health-Related Quality of Life From Baseline
11181626|NCT02068729|OG004|Outcome|12 Months|Change in Health-Related Quality of Life From Baseline
11181627|NCT02068729|OG005|Outcome|24 Months|Change in Health-Related Quality of Life From Baseline
11181628|NCT02068729|OG000|Outcome|Level 1|One vertebrae level analyzed
11181629|NCT02068729|OG001|Outcome|Superior|Analysis of the upper level of a two-level vertebrae
11181630|NCT02068729|OG002|Outcome|Inferior|Analysis of the lower level of a two-level vertebrae
11181631|NCT02068729|OG000|Outcome|12 Month|Patient satisfaction at 12 Month
11181632|NCT02068729|OG001|Outcome|Repeat Procedure|Patient satisfaction at 24 Month
11181633|NCT02068729|OG000|Outcome|24 Month|Odom's criteria
11181634|NCT02068729|OG000|Outcome|Surgery Time|The length of the surgical procedure
11181635|NCT02068729|OG000|Outcome|Anesthesia Time|The length of time the patient is under anesthesia
11181636|NCT02068729|OG000|Outcome|Estimated Blood Loss|The amount of blood loss over the entire length of the surgery
11181637|NCT02068729|OG000|Outcome|Train of Four|Abnormal result(s) of neuromonitoring systems utilized during the surgery
11181638|NCT02068729|OG001|Outcome|Electromyography (EMG)|Abnormal result(s) of neuromonitoring systems utilized during the surgery
11181639|NCT02068729|OG002|Outcome|Triggered EMG|Abnormal result(s) of neuromonitoring systems utilized during the surgery
11181640|NCT02068729|OG003|Outcome|Somato Sensory Evoked Potential (SSEP)|Abnormal result(s) of neuromonitoring systems utilized during the surgery
11181641|NCT02068729|OG004|Outcome|Motor Evoked Potential (MEP)|Abnormal result(s) of neuromonitoring systems utilized during the surgery
11181642|NCT02068729|OG000|Outcome|Length of Hospital Stay|The length of hospital stay from the date of hospital admission to the date of discharge
11181643|NCT02068729|OG000|Outcome|Pre-Op|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery
11181644|NCT02068729|OG001|Outcome|Initial Post-Operative|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery
11181645|NCT02068729|OG002|Outcome|3 Months|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery
11181646|NCT02068729|OG003|Outcome|6 Months|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery
11181647|NCT02068729|OG004|Outcome|12 Months|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery
11181648|NCT02068729|OG005|Outcome|24 Months|The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery
11181649|NCT02068729|OG000|Outcome|Pre-Op|The types and dosages of any narcotics taken by the patient post-surgery
11181650|NCT02068729|OG001|Outcome|Initial Post-Operative|The types and dosages of any narcotics taken by the patient post-surgery
11181651|NCT02068729|OG002|Outcome|3 Months|The types and dosages of any narcotics taken by the patient post-surgery
11181652|NCT02068729|OG003|Outcome|6 Months|The types and dosages of any narcotics taken by the patient post-surgery
11181653|NCT02068729|OG004|Outcome|12 Months|The types and dosages of any narcotics taken by the patient post-surgery
11181654|NCT02068729|OG005|Outcome|24 Months|The types and dosages of any narcotics taken by the patient post-surgery
11181655|NCT02068729|EG000|Reported Event|Participants With Adverse Events|"Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events.~9 of the 30 SAE participants did not experience a non-SAE events. The other 21 participants had events in both categories.~The study did not establish a frequency threshold, therefore, all AEs are listed."
11181656|NCT02068768|BG000|Baseline|Operated Subjects|"Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1~Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine"
11181657|NCT02068768|FG000|Participant Flow|Operated Subjects|"Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1~Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine"
11181658|NCT02068768|OG000|Outcome|Operated Subjects|"Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1~Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine"
11181659|NCT02068768|EG000|Reported Event|Operated Subjects|"Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1~Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine"
11181660|NCT02068820|BG000|Baseline|ISB Dye, Standard White Light|"SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.~ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging."
11181661|NCT02068820|BG001|Baseline|ICG Dye, FireFly Fluorescence Imaging|"SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.~ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.~ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging."
11181662|NCT02068820|BG002|Baseline|Total|Total of all reporting groups
11181663|NCT02068820|FG000|Participant Flow|ISB Dye, Standard White Light|"SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.~ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging."
11181664|NCT02068820|FG001|Participant Flow|ICG Dye, FireFly Fluorescence Imaging|"SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.~ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.~ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging."
11181665|NCT02068820|OG000|Outcome|ISB Dye, Standard White Light|"SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.~ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging."
11181666|NCT02068820|OG001|Outcome|ICG Dye, FireFly Fluorescence Imaging|"SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.~ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.~ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging."
11181667|NCT02068820|OG000|Outcome|ICG Negative|Experimental subjects with Indocyanine Green (ICG) negative test results
11181668|NCT02068820|OG001|Outcome|ICG Positive|Experimental subjects with Indocyanine Green (ICG) positive test results
11181669|NCT02068820|OG000|Outcome|IHC Only|Positive node identified with IHC dye only
11181670|NCT02068820|OG001|Outcome|H&E Only|Positive node identified with H&E only
11181671|NCT02068820|OG002|Outcome|Both IHC and H&E|Positive node identified with both IHC and H&E dye
11181672|NCT02068820|EG000|Reported Event|ISB Only Adverse Events|ISB only Adverse Events categories reported during post-op follow up 6 weeks
11181673|NCT02068820|EG001|Reported Event|ICG Adverse Events|ICG Adverse Events categories reported during post-op follow up 6 weeks
11181674|NCT02068846|BG000|Baseline|Ciprofloxacin|"Active treatment twice daily for 28 days~Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days."
11181675|NCT02068846|BG001|Baseline|Placebo|"Placebo treatment twice daily for 28 days~Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days."
11181676|NCT02068846|BG002|Baseline|Total|Total of all reporting groups
11181677|NCT02068846|FG000|Participant Flow|Ciprofloxacin|"Active treatment twice daily for 28 days~Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days."
11181678|NCT02068846|FG001|Participant Flow|Placebo|"Placebo treatment twice daily for 28 days~Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days."
11181679|NCT02068846|OG000|Outcome|Ciprofloxacin|"Active treatment twice daily for 28 days~Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days."
11181680|NCT02068846|OG001|Outcome|Placebo|"Placebo treatment twice daily for 28 days~Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days."
11181681|NCT02068846|EG000|Reported Event|Ciprofloxacin|"Active treatment twice daily for 28 days~Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days."
11181682|NCT02068846|EG001|Reported Event|Placebo|"Placebo treatment twice daily for 28 days~Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days."
11181683|NCT02068885|BG000|Baseline|Low Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181684|NCT02068885|BG001|Baseline|Moderate Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181685|NCT02068885|BG002|Baseline|High Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181686|NCT02068885|BG003|Baseline|Total|Total of all reporting groups
11181687|NCT02068885|FG000|Participant Flow|Low Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181688|NCT02068885|FG001|Participant Flow|Moderate Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181689|NCT02068885|FG002|Participant Flow|High Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181690|NCT02068885|OG000|Outcome|Low Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181691|NCT02068885|OG001|Outcome|Moderate Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181692|NCT02068885|OG002|Outcome|High Carbohydrate Diet|"Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein~Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum"
11181693|NCT02068885|EG000|Reported Event|Run-in Phase|Pre-randomization: During the run-in phase, energy intake was restricted to promote 12% (within 2%) weight loss over 9-10 weeks.
11181694|NCT02068885|EG001|Reported Event|Low Carbohydrate Diet|Feeding study: Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein.
11181695|NCT02068885|EG002|Reported Event|Moderate Carbohydrate Diet|Feeding study: Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein.
11181696|NCT02068885|EG003|Reported Event|High Carbohydrate Diet|Feeding study: Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
11181697|NCT02069015|BG000|Baseline|Intervention|Patient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge. Patient education on hypertension delivered through a touchscreen kiosk.
11181698|NCT02069015|BG001|Baseline|Control|Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription.
11181699|NCT02069015|BG002|Baseline|Total|Total of all reporting groups
11181700|NCT02069015|FG000|Participant Flow|Enhanced Discharge|"Patient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge.~Patient education: Patient education on hypertension delivered through a touchscreen kiosk."
11181701|NCT02069015|FG001|Participant Flow|Standard Discharge|Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription
11181702|NCT02069015|OG000|Outcome|Control Group|All participants received hypertensive regimen
11181703|NCT02069015|OG001|Outcome|Intervention Group|All participants received hypertensive regimen and education intervention
11181704|NCT02069015|OG000|Outcome|Patient Activation Measure (PAM)|PAM sample at baseline is 4 levels; (1) awareness; (2) confidence; (3) action; (4) maintenance.
11181705|NCT02069015|EG000|Reported Event|Enhanced Discharge|"Patient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge.~Patient education: Patient education on hypertension delivered through a touchscreen kiosk."
11181706|NCT02069015|EG001|Reported Event|Standard Discharge|Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription
11181707|NCT02069041|BG000|Baseline|Ramucirumab + FOLFOX4|"8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:~FOLFOX4 every 2 weeks:~85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2~Participants may continue to receive treatment until discontinuation criteria are met."
11181708|NCT02069041|FG000|Participant Flow|Ramucirumab + FOLFOX4|"8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:~FOLFOX4 every 2 weeks:~85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2~Participants may continue to receive treatment until discontinuation criteria are met."
11181709|NCT02069041|OG000|Outcome|Ramucirumab + FOLFOX4|"8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:~FOLFOX4 every 2 weeks:~85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2~Participants may continue to receive treatment until discontinuation criteria are met."
11181710|NCT02069041|EG000|Reported Event|Ramucirumab + FOLFOX4|"8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:~FOLFOX4 every 2 weeks:~85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2~Participants may continue to receive treatment until discontinuation criteria are met."
11181711|NCT02069093|BG000|Baseline|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
11181712|NCT02069093|FG000|Participant Flow|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
11181713|NCT02069093|OG000|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
11181714|NCT02069093|EG000|Reported Event|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
11181715|NCT02069119|BG000|Baseline|OPC-108459（Paroxysmal）|
11181716|NCT02069119|BG001|Baseline|Placebo（Paroxysmal）|
11181717|NCT02069119|BG002|Baseline|OPC-108459（Persistent）|
11181718|NCT02069119|BG003|Baseline|Placebo（Persistent）|
11181719|NCT02069119|BG004|Baseline|Total|Total of all reporting groups
11181720|NCT02069119|FG000|Participant Flow|OPC-108459（Paroxysmal AF）|Randomized: 20/24 subjects
11181721|NCT02069119|FG001|Participant Flow|Placebo（Paroxysmal AF）|Randomized: 4/24 subjects
11181722|NCT02069119|FG002|Participant Flow|OPC-108459 (Persistent AF)|Randomized: 20/24 subjects
11181723|NCT02069119|FG003|Participant Flow|Placebo (Persistent AF）|Randomized: 4/24 subjects
11181724|NCT02069119|OG000|Outcome|OPC-108459 Step 1 (0.4 mg/kg)|
11181725|NCT02069119|OG001|Outcome|OPC-108459 Step 2 （0.8 mg/kg）|
11181726|NCT02069119|OG002|Outcome|OPC-108459 Step 3 （1.6mg/kg）|
11181727|NCT02069119|OG003|Outcome|OPC-108459 Step 4 （2.6 mg/kg）|
11181728|NCT02069119|OG004|Outcome|Placebo|
11181729|NCT02069119|OG000|Outcome|OPC-108459 Step 1 （0.4 mg/kg）|
11181730|NCT02069119|EG000|Reported Event|OPC-108459（Paroxysmal）|A total of 112 subjects were enrolled and screened, and 48 subjects were randomized to either the OPC-108459 group or placebo group. Of the 48 subjects, 24 subjects were randomized to paroxysmal AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects received the Interventional medicinal product (IMP) administration and were included in the FAS. Of the 24 subjects, 18 subjects were included in the PK analysis set.
11181731|NCT02069119|EG001|Reported Event|OPC-108459（Persistent）|Of the 48 subjects, 24 subjects were randomized to persistent AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects in Persistent AF cohort received the IMP administration and were included in the FAS and PK analysis set.
11181732|NCT02069119|EG002|Reported Event|Placebo（Paroxysmal）|A total of 112 subjects were enrolled and screened, and 48 subjects were randomized to either the OPC-108459 group or placebo group. Of the 48 subjects, 24 subjects were randomized to paroxysmal AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects received the Interventional medicinal product (IMP) administration and were included in the FAS. Of the 24 subjects, 18 subjects were included in the PK analysis set.
11181733|NCT02069119|EG003|Reported Event|Placebo（Persistent）|Of the 48 subjects, 24 subjects were randomized to persistent AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects in Persistent AF cohort received the IMP administration and were included in the FAS and PK analysis set.
11181734|NCT02069184|BG000|Baseline|IV Acetaminophen|"IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours.~IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly"
11181735|NCT02069184|BG001|Baseline|Saline as Placebo|"IV form, total 4 units, each given every 6th hourly in 24 hours.~Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly."
11181736|NCT02069184|BG002|Baseline|Total|Total of all reporting groups
11181737|NCT02069184|FG000|Participant Flow|IV Acetaminophen|"IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours.~IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly"
11181738|NCT02069184|FG001|Participant Flow|Saline as Placebo|"IV form, total 4 units, each given every 6th hourly in 24 hours.~Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly."
11181739|NCT02069184|OG000|Outcome|IV Acetaminophen|"IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours.~IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly"
11181740|NCT02069184|OG001|Outcome|Saline as Placebo|"IV form, total 4 units, each given every 6th hourly in 24 hours.~Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly."
11181741|NCT02069184|EG000|Reported Event|IV Acetaminophen|"IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours.~IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly"
11181742|NCT02069184|EG001|Reported Event|Saline as Placebo|"IV form, total 4 units, each given every 6th hourly in 24 hours.~Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly."
11181743|NCT02069353|BG000|Baseline|Cardiac Arrest|"Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring.~QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)~Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)"
11181744|NCT02069353|FG000|Participant Flow|Cardiac Arrest|"Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring.~QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)~Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)"
11181745|NCT02069353|OG000|Outcome|Cardiac Arrest|"Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring.~QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)~Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)"
11181746|NCT02069353|EG000|Reported Event|Cardiac Arrest|"Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring.~QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)~Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)"
11181747|NCT02069379|BG000|Baseline|Controls|metabolically healthy controls will participate in baseline assessments only, and will not be randomized to the placebo and metformin treatment arms.
11181748|NCT02069379|BG001|Baseline|Insulin Resistant Participants|Women classified as insulin resistant will participate in both a placebo and a metformin treatment arm, each lasting about 16 weeks. Women will be randomized to order of treatment arms.
11181749|NCT02069379|BG002|Baseline|Total|Total of all reporting groups
11181750|NCT02069379|FG000|Participant Flow|Controls|metabolically healthy controls will participate in baseline assessments only, and will not be randomized to the placebo and metformin treatment arms.
11181751|NCT02069379|FG001|Participant Flow|Insulin Resistant Participants (Placebo First)|Women classified as insulin resistant will participate in both a placebo and a metformin treatment arm, each lasting about 16 weeks. Women will be randomized to order of treatment arms.
11181752|NCT02069379|FG002|Participant Flow|Insulin Resistant Participants (Metformin First)|Women classified as insulin resistant and randomized to Metformin treatment arm 1st and Placebo treatment arm 2nd
11181753|NCT02069379|FG003|Participant Flow|Insulin Resistant (Not Randomized)|Insulin resistant participants not randomized to treatment arms
11181754|NCT02069379|OG000|Outcome|Controls|metabolically healthy controls will participate in baseline assessments only, and will not be randomized to the placebo and metformin treatment arms.
11181755|NCT02069379|OG001|Outcome|Metformin|"16 weeks treatment with metformin (insulin sensitizing treatment)~Metformin: Women classified as insulin resistant will participate in both a placebo and a metformin treatment arm, each lasting about 16 weeks. Women will be randomized to order of treatment arms."
11181756|NCT02069379|OG002|Outcome|Placebo|"Placebo comparator to metformin treatment~Placebo: Placebo capsules prepared identically to Metformin capsules"
11181757|NCT02069379|OG001|Outcome|Insulin Resistant Participants|Women classified as insulin resistant will participate in both a placebo and a metformin treatment arm, each lasting about 16 weeks. Women will be randomized to order of treatment arms.
11181758|NCT02069379|EG000|Reported Event|Controls|metabolically healthy controls will participate in baseline assessments only, and will not be randomized to the placebo and metformin treatment arms.
11181759|NCT02069379|EG001|Reported Event|Placebo (First Assignment & Washout or Second Assignment)|"Placebo comparator to metformin treatment~Placebo: Placebo capsules prepared identically to Metformin capsules"
11181760|NCT02069379|EG002|Reported Event|Metformin (First Assignment & Washout or Second Assignment)|"16 weeks treatment with metformin (insulin sensitizing treatment)~Metformin: Women classified as insulin resistant will participate in both a placebo and a metformin treatment arm, each lasting about 16 weeks. Women will be randomized to order of treatment arms."
11181761|NCT02069379|EG003|Reported Event|Insulin-resistant Women Not Randomized|These participants, like controls, did not continue beyond baseline and were not assigned any metformin or placebo.
11181762|NCT02069392|BG000|Baseline|Cognitive Remediation Training With Nicotine|"Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.~Cognitive remediation training~Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits."
11181763|NCT02069392|BG001|Baseline|Cognitive Remediation Training Without Nicotine|"Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.~Cognitive remediation training"
11181764|NCT02069392|BG002|Baseline|Total|Total of all reporting groups
11181765|NCT02069392|FG000|Participant Flow|Cognitive Remediation Training With Nicotine|"Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.~Cognitive remediation training~Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits."
11181766|NCT02069392|FG001|Participant Flow|Cognitive Remediation Training Without Nicotine|"Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.~Cognitive remediation training"
11181767|NCT02069392|OG000|Outcome|Cognitive Remediation Training With Nicotine|"Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.~Cognitive remediation training~Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits."
11181768|NCT02069392|OG001|Outcome|Cognitive Remediation Training Without Nicotine|"Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.~Cognitive remediation training"
11181769|NCT02069392|OG000|Outcome|Cognitive Remediation Training With Nicotine|"Participants will complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants will consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.~Cognitive remediation training~Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits."
11181770|NCT02069392|OG001|Outcome|Cognitive Remediation Training Without Nicotine|"Participants will complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants will consume a placebo lozenge prior to the training.~Cognitive remediation training"
11181771|NCT02069392|EG000|Reported Event|Cognitive Remediation Training With Nicotine|"Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.~Cognitive remediation training~Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits."
11181772|NCT02069392|EG001|Reported Event|Cognitive Remediation Training Without Nicotine|"Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.~Cognitive remediation training"
11181773|NCT02069704|BG000|Baseline|Bevacizumab Biosimilar (BEVZ92)|Bevacizumab biosimilar (BEVZ92): Bevacizumab biosimilar (BEVZ92), Active ingredient Bevacizumab 25 mg/mL (strength = 100mg/mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri).
11181774|NCT02069704|BG001|Baseline|Avastin® (Bevacizumab, Ref. Product)|"Avastin® (bevacizumab, reference product): Avastin® (bevacizumab, reference product).~Active ingredient: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to administration of chemotherapy (Folfox any or Folfiri)."
11181775|NCT02069704|BG002|Baseline|Total|Total of all reporting groups
11181776|NCT02069704|FG000|Participant Flow|Bevacizumab Biosimilar (BEVZ92)|Bevacizumab biosimilar (BEVZ92): Bevacizumab biosimilar (BEVZ92), Active ingredient Bevacizumab 25 mg/mL (strength = 100mg/mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri).
11181777|NCT02069704|FG001|Participant Flow|Avastin® (Bevacizumab, Ref. Product)|"Avastin® (bevacizumab, reference product): Avastin® (bevacizumab, reference product).~Active ingredient: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to administration of chemotherapy (Folfox any or Folfiri)."
11181778|NCT02069704|OG000|Outcome|Bevacizumab Biosimilar (BEVZ92)|Bevacizumab proposed biosimilar (BEVZ92)
11181779|NCT02069704|OG001|Outcome|Avastin® (Bevacizumab, Ref. Product).|Avastin® (bevacizumab, reference product).
11181780|NCT02069704|OG000|Outcome|Bevacizumab Biosimilar (BEVZ92)|"Bevacizumab proposed biosimilar (BEVZ92):~Active ingredient Bevacizumab 25 mg/mL (strength = 100mg/mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri)."
11181781|NCT02069704|OG001|Outcome|Avastin® (Bevacizumab, Ref. Product).|Bevacizumab reference product: Active ingredient Bevacizumab 25 mg/mL (strength = 100mg/mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri).
11181782|NCT02069704|OG000|Outcome|Bevacizumab Biosimilar (BEVZ92)|"Bevacizumab 25 mg/mL (strength: 100 mg/4 mL).~Bevacizumab biosimilar (BEVZ92): Bevacizumab biosimilar (BEVZ92), Active ingredient Bevacizumab 25 mg/mL (strength = 100mg/mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri)."
11181783|NCT02069704|OG001|Outcome|Avastin® (Bevacizumab, Ref. Product)|"Bevacizumab 25mg/ml (strength: 100mg/4ml)~Avastin® (bevacizumab, reference product): Avastin® (bevacizumab, reference product). Active ingredient: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to administration of chemotherapy (Folfox any or Folfiri)."
11181784|NCT02069704|OG001|Outcome|Avastin® (Bevacizumab, Ref. Product)|"Bevacizumab 25mg/ml (strength: 100mg/4ml)~Avastin® (bevacizumab, reference product): Avastin® (bevacizumab, reference product).~Active ingredient: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to administration of chemotherapy (Folfox any or Folfiri)."
11181785|NCT02069704|OG001|Outcome|Avastin® (Bevacizumab, Ref. Product).|"Bevacizumab reference product:~Active ingredient Bevacizumab 25 mg/mL (strength = 100mg/mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri)."
11181786|NCT02069704|OG001|Outcome|Avastin® (Bevacizumab, Ref. Product)|"Bevacizumab reference product:~Active ingredient Bevacizumab 25 mg/mL (strength = 100mg/mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri)."
11181787|NCT02069704|EG000|Reported Event|Bevacizumab Biosimilar (BEVZ92)|Bevacizumab biosimilar (BEVZ92): Bevacizumab biosimilar (BEVZ92), Active ingredient Bevacizumab 25 mg/mL (strength = 100mg/mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri).
11181788|NCT02069704|EG001|Reported Event|Avastin® (Bevacizumab, Ref. Product)|"Avastin® (bevacizumab, reference product): Avastin® (bevacizumab, reference product).~Active ingredient: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to administration of chemotherapy (Folfox any or Folfiri)."
11181789|NCT02069847|BG000|Baseline|Esophageal Stricture, Budesonide|"Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection or endoscopic mucosal resection~Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply.~The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup.~Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide."
11181790|NCT02069847|BG001|Baseline|Control Group|Retrospective collect data for subjects who undergo endoscopic submucosal dissection or endoscopic mucosal resection
11181791|NCT02069847|BG002|Baseline|Total|Total of all reporting groups
11181792|NCT02069847|FG000|Participant Flow|Esophageal Stricture, Budesonide|"Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)~Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply.~The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup.~Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide."
11181793|NCT02069847|FG001|Participant Flow|Control Group|Retrospective collect data for subjects who undergo endoscopic submucosal dissection or endoscopic mucosal resection
11181794|NCT02069847|OG000|Outcome|Esophageal Stricture, Budesonide|"Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection or endoscopic mucosal resection~Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply.~The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup.~Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide."
11181795|NCT02069847|OG001|Outcome|Control Group|Retrospective collect data for subjects who undergo endoscopic submucosal dissection or endoscopic mucosal resection
11181796|NCT02069847|EG000|Reported Event|Esophageal Stricture, Budesonide|"Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection or endoscopic mucosal resection~Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply.~The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup.~Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide."
11181797|NCT02070237|BG000|Baseline|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
11181798|NCT02070237|BG001|Baseline|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
11181799|NCT02070237|BG002|Baseline|Total|Total of all reporting groups
11181800|NCT02070237|FG000|Participant Flow|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
11181801|NCT02070237|FG001|Participant Flow|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
11181802|NCT02070237|OG000|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
11181803|NCT02070237|OG001|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
11181804|NCT02070237|EG000|Reported Event|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
11181805|NCT02070237|EG001|Reported Event|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
11181806|NCT02070276|BG000|Baseline|Standard Clinical Practice|"This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.~Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation."
11181807|NCT02070276|BG001|Baseline|Trans-Thoracic Echocardiography|"In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.~According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.~Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not."
11181808|NCT02070276|BG002|Baseline|Passive Leg Raising Test|"In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.~If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.~Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia."
11181809|NCT02070276|BG003|Baseline|Total|Total of all reporting groups
11181810|NCT02070276|FG000|Participant Flow|Standard Clinical Practice|"This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.~Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation."
11192338|NCT02138240|BG000|Baseline|Social Network Intervention|"Individuals will be recruited and trained to be Peer Educators who will participate in group sessions and then communicate this information with members of their social network (Sidekick) and work to make changes to reduce intake of sugar-sweetened beverages. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions over the subsequent 3 months after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide.~Social network intervention: The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB."
11181811|NCT02070276|FG001|Participant Flow|Trans-Thoracic Echocardiography|"In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.~According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.~Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not."
11181812|NCT02070276|FG002|Participant Flow|Passive Leg Raising Test|"In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.~If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.~Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia."
11181813|NCT02070276|OG000|Outcome|Arm A|"This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.~Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation."
11181814|NCT02070276|OG001|Outcome|Arm B|"In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.~According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.~Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not."
11181815|NCT02070276|OG002|Outcome|Arm C|"In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.~If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.~Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia."
11181816|NCT02070276|EG000|Reported Event|Standard Clinical Practice|"This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.~Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation."
11181817|NCT02070276|EG001|Reported Event|Trans-Thoracic Echocardiography|"In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.~According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.~Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not."
11192339|NCT02138240|FG000|Participant Flow|Social Network Intervention|"Individuals will be recruited and trained to be Peer Educators who will participate in group sessions and then communicate this information with members of their social network (Sidekick) and work to make changes to reduce intake of sugar-sweetened beverages. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions over the subsequent 3 months after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide.~Social network intervention: The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB."
11181818|NCT02070276|EG002|Reported Event|Passive Leg Raising Test|"In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.~If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.~Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia."
11181819|NCT02070302|BG000|Baseline|Botulinum Toxin Type A (Onabot)|A prospective, randomized, double blind pilot study of patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). For 5 out of 10 subjects, non-dominant hands were injected under ultrasound guidance with 40 units of Onabot (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks.
11181820|NCT02070302|BG001|Baseline|Placebo|A prospective, randomized, double blind pilot study of 10 patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). Non-dominant hands were injected under ultrasound guidance with 40 units of 40 units of normal saline (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks.
11181821|NCT02070302|BG002|Baseline|Total|Total of all reporting groups
11181822|NCT02070302|FG000|Participant Flow|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
11181823|NCT02070302|FG001|Participant Flow|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
11181824|NCT02070302|OG000|Outcome|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
11181825|NCT02070302|OG001|Outcome|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
11181826|NCT02070302|EG000|Reported Event|Botulinum Toxin Type A|At 18 weeks, mean distal motor latency changes of -0.6 ms (P-value = 0.078) in the Onabot group were noted; and distal sensory latency changes of -0.3ms in the Onabot group; less slowing. Decreased mean cross-sectional area of -2.2 mm2 (P-value =0.040) in Onabot group were noted; less nerve edema. Decreased percent compression of the median nerve during stress testing was -12.6% in Onabot group. Three subjects injected with Onabot demonstrated decreases in median distal motor latencies that were nearly significant (p-value<.1, >.05), Two had decreases in median distal sensory latencies, and some had decreases in cross-sectional area on NMUS that were nearly significant. One Onabot subject did not show improvement or changes in median distal latencies but remained stable while the non-injected hand worsened with increasing median distal latencies.
11181827|NCT02070302|EG001|Reported Event|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
11181828|NCT02070380|BG000|Baseline|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
11181829|NCT02070380|BG001|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
11181830|NCT02070380|BG002|Baseline|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
11181831|NCT02070380|BG003|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
11181832|NCT02070380|BG004|Baseline|Total|Total of all reporting groups
11181833|NCT02070380|FG000|Participant Flow|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
11181834|NCT02070380|FG001|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
11181835|NCT02070380|FG002|Participant Flow|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
11181836|NCT02070380|FG003|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
11181837|NCT02070380|OG000|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
11181838|NCT02070380|OG001|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
11181839|NCT02070380|OG002|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
11181840|NCT02070380|OG003|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
11181841|NCT02070380|OG004|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
11181842|NCT02070380|OG005|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
11181843|NCT02070380|EG000|Reported Event|Study Arm 1 / MultiHance 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with MultiHance 0.1 mmol/kg.~31 (MH as 1st injection) + 34 (MH as 2nd injection) = 65"
11181844|NCT02070380|EG001|Reported Event|Study Arm 1 / Dotarem 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.~39 (Dotarem as 1st injection) + 31 (Dotarem as 2nd injection) =70"
11181845|NCT02070380|EG002|Reported Event|Study Arm 2/ MultiHance 0.05 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with MultiHance 0.05 mmol/kg.~53 (MH as 1st injection) + 51 (MH as 2nd injection) = 104"
11181846|NCT02070380|EG003|Reported Event|Study Arm 2 / Dotarem 0.1 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.~54 (Dotarem as 1st injection) + 51 (Dotarem as 2nd injection) =105"
11181847|NCT02070484|BG000|Baseline|NuCel|"Stemcell allograft~NuCel"
11181848|NCT02070484|BG001|Baseline|Demineralized Bone Matrix (DBM)|"Demineralized Bone Matrix (DBM) bone graft substitute~Demineralized Bone Matrix"
11181849|NCT02070484|BG002|Baseline|Total|Total of all reporting groups
11181850|NCT02070484|FG000|Participant Flow|NuCel|"Stemcell allograft~NuCel"
11181851|NCT02070484|FG001|Participant Flow|Demineralized Bone Matrix (DBM)|"Demineralized Bone Matrix (DBM) bone graft substitute~Demineralized Bone Matrix"
11181852|NCT02070484|OG000|Outcome|NuCel|"Stemcell allograft~NuCel"
11181853|NCT02070484|OG001|Outcome|Demineralized Bone Matrix (DBM)|"Demineralized Bone Matrix (DBM) bone graft substitute~Demineralized Bone Matrix"
11181854|NCT02070484|EG000|Reported Event|NuCel|"Stemcell allograft~NuCel"
11181855|NCT02070484|EG001|Reported Event|Demineralized Bone Matrix (DBM)|"Demineralized Bone Matrix (DBM) bone graft substitute~Demineralized Bone Matrix"
11181856|NCT02070588|BG000|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181857|NCT02070588|BG001|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181858|NCT02070588|BG002|Baseline|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181859|NCT02070588|BG003|Baseline|Total|Total of all reporting groups
11181860|NCT02070588|FG000|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181861|NCT02070588|FG001|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181862|NCT02070588|FG002|Participant Flow|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181863|NCT02070588|OG000|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181864|NCT02070588|OG001|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181865|NCT02070588|OG002|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181866|NCT02070588|EG000|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181867|NCT02070588|EG001|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181868|NCT02070588|EG002|Reported Event|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
11181869|NCT02070640|BG000|Baseline|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181870|NCT02070640|BG001|Baseline|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181871|NCT02070640|BG002|Baseline|Total|Total of all reporting groups
11181872|NCT02070640|FG000|Participant Flow|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181873|NCT02070640|FG001|Participant Flow|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181874|NCT02070640|OG000|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181875|NCT02070640|OG001|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181876|NCT02070640|OG000|Outcome|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181877|NCT02070640|EG000|Reported Event|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181878|NCT02070640|EG001|Reported Event|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
11181879|NCT02070692|BG000|Baseline|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
11181880|NCT02070692|BG001|Baseline|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
11181881|NCT02070692|BG002|Baseline|Total|Total of all reporting groups
11181882|NCT02070692|FG000|Participant Flow|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
11181883|NCT02070692|FG001|Participant Flow|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
11181884|NCT02070692|OG000|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
11181885|NCT02070692|OG001|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
11181886|NCT02070692|EG000|Reported Event|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
11181887|NCT02070692|EG001|Reported Event|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
11191331|NCT02131766|FG000|Participant Flow|USS Virginia Closed Loop Control and SAP|"The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM.~A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission.~DiAs: DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and"
11191332|NCT02131766|OG000|Outcome|USS Virginia Closed Loop Control|"The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM.~A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission.~DiAs: DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and"
11181888|NCT02070744|BG000|Baseline|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
11181889|NCT02070744|BG001|Baseline|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
11181890|NCT02070744|BG002|Baseline|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
11181891|NCT02070744|BG003|Baseline|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
11181892|NCT02070744|BG004|Baseline|Total|Total of all reporting groups
11181893|NCT02070744|FG000|Participant Flow|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 milligram (mg) tablet plus IVA 150 mg tablet every 12 hours (q12h) for 12 weeks.
11181894|NCT02070744|FG001|Participant Flow|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
11181895|NCT02070744|FG002|Participant Flow|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets once daily (qd) plus IVA 150 mg tablet q12h for 12 weeks.
11181896|NCT02070744|FG003|Participant Flow|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
11181897|NCT02070744|FG004|Participant Flow|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
11181898|NCT02070744|OG000|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
11181899|NCT02070744|OG001|Outcome|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
11181900|NCT02070744|OG002|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
11181901|NCT02070744|OG003|Outcome|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
11181902|NCT02070744|OG000|Outcome|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
11181903|NCT02070744|OG000|Outcome|OLE Phase:VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
11181904|NCT02070744|OG000|Outcome|PC Phase: VX-661 50 mg + IVA 150 mg|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
11181905|NCT02070744|OG001|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
11181906|NCT02070744|EG000|Reported Event|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
11181907|NCT02070744|EG001|Reported Event|PC Phase: VX 661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
11181908|NCT02070744|EG002|Reported Event|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
11181909|NCT02070744|EG003|Reported Event|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
11181910|NCT02070744|EG004|Reported Event|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
11181911|NCT02070757|BG000|Baseline|Ceftolozane/Tazobactam|Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).
11181912|NCT02070757|BG001|Baseline|Meropenem|Participants receive 1000 mg meropenem administered as an IV infusion q8h.
11181913|NCT02070757|BG002|Baseline|Total|Total of all reporting groups
11181914|NCT02070757|FG000|Participant Flow|Ceftolozane/Tazobactam|Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).
11181915|NCT02070757|FG001|Participant Flow|Meropenem|Participants receive 1000 mg meropenem administered as an IV infusion q8h.
11181916|NCT02070757|OG000|Outcome|Ceftolozane/Tazobactam|Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).
11181917|NCT02070757|OG001|Outcome|Meropenem|Participants receive 1000 mg meropenem administered as an IV infusion q8h.
11181918|NCT02070757|EG000|Reported Event|Ceftolozane/Tazobactam|Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).
11181919|NCT02070757|EG001|Reported Event|Meropenem|Participants receive 1000 mg meropenem administered as an IV infusion q8h.
11181920|NCT02070965|BG000|Baseline|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
11181921|NCT02070965|BG001|Baseline|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
11181922|NCT02070965|BG002|Baseline|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
11181923|NCT02070965|BG003|Baseline|Total|Total of all reporting groups
11181924|NCT02070965|FG000|Participant Flow|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
11181925|NCT02070965|FG001|Participant Flow|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
11181926|NCT02070965|FG002|Participant Flow|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
11181927|NCT02070965|OG000|Outcome|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
11181928|NCT02070965|OG001|Outcome|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
11181929|NCT02070965|OG002|Outcome|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
11181930|NCT02070965|EG000|Reported Event|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
11181931|NCT02070965|EG001|Reported Event|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
11181932|NCT02070965|EG002|Reported Event|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
11181933|NCT02070978|BG000|Baseline|Placebo/Atacicept 150 mg|Participants received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.
11181934|NCT02070978|BG001|Baseline|Atacicept 75 mg|Participants received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.
11181935|NCT02070978|BG002|Baseline|Atacicept 150 mg|Participants received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.
11181936|NCT02070978|BG003|Baseline|Total|Total of all reporting groups
11181937|NCT02070978|FG000|Participant Flow|Placebo/Atacicept 150 mg|Participants received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.
11181938|NCT02070978|FG001|Participant Flow|Atacicept 75 mg|Participants received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.
11181939|NCT02070978|FG002|Participant Flow|Atacicept 150 mg|Participants received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.
11181940|NCT02070978|OG000|Outcome|Placebo/Atacicept 150 mg|Participants received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.
11181941|NCT02070978|OG001|Outcome|Atacicept 75 mg|Participants received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.
11181942|NCT02070978|OG002|Outcome|Atacicept 150 mg|Participants received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.
11181943|NCT02070978|EG000|Reported Event|Placebo/Atacicept 150 mg|Participants received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.
11181944|NCT02070978|EG001|Reported Event|Atacicept 75 mg|Participants received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.
11181945|NCT02070978|EG002|Reported Event|Atacicept 150 mg|Participants received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.
11181946|NCT02070991|BG000|Baseline|Macitentan|Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
11181947|NCT02070991|BG001|Baseline|Placebo|Matching placebo to be taken once daily, oral use, film-coated tablet
11181948|NCT02070991|BG002|Baseline|Total|Total of all reporting groups
11181949|NCT02070991|FG000|Participant Flow|Macitentan|Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
11181950|NCT02070991|FG001|Participant Flow|Placebo|Matching placebo to be taken once daily, oral use, film-coated tablet
11181951|NCT02070991|OG000|Outcome|Macitentan|Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
11181952|NCT02070991|OG001|Outcome|Placebo|Matching placebo to be taken once daily, oral use, film-coated tablet
11181953|NCT02070991|EG000|Reported Event|Macitentan|Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
11181954|NCT02070991|EG001|Reported Event|Placebo|Matching placebo to be taken once daily, oral use, film-coated tablet
11181955|NCT02071082|BG000|Baseline|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
11181956|NCT02071082|BG001|Baseline|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
11181957|NCT02071082|BG002|Baseline|Total|Total of all reporting groups
11181958|NCT02071082|FG000|Participant Flow|HIV/HBV Treatment-Naive (Cohort 1)|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.
11181959|NCT02071082|FG001|Participant Flow|HIV-Suppressed (Cohort 2)|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
11181960|NCT02071082|OG000|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
11181961|NCT02071082|OG001|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
11181962|NCT02071082|EG000|Reported Event|HIV/HBV Treatment-Naive|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV treatment-naive and HBV treatment-naive)
11181963|NCT02071082|EG001|Reported Event|HIV-Suppressed|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
11181964|NCT02071095|BG000|Baseline|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
11181965|NCT02071095|BG001|Baseline|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
11181966|NCT02071095|BG002|Baseline|Total|Total of all reporting groups
11181967|NCT02071095|FG000|Participant Flow|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
11181968|NCT02071095|FG001|Participant Flow|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
11181969|NCT02071095|OG000|Outcome|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
11181970|NCT02071095|OG001|Outcome|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
11181971|NCT02071095|EG000|Reported Event|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
11181972|NCT02071095|EG001|Reported Event|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
11181973|NCT02071108|BG000|Baseline|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
11181974|NCT02071108|FG000|Participant Flow|Lithoplasty Treatment|All subjects were treated with the Shockwave Medical Peripheral Lithoplasty System
11181975|NCT02071108|OG000|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
11181976|NCT02071108|EG000|Reported Event|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
11181977|NCT02071173|BG000|Baseline|NAVIGATE X4 Study Participants|"All subjects that signed the informed consent were included.~Subjects consent to undergo an implant procedure to receive an ACUITY X4 LV lead and/or a RELIANCE 4-FRONT RV lead.~ACUITY X4 quadripolar coronary venous lead: The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies.~RELIANCE 4-FRONT defibrillation lead: The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible ICD or CRT-D."
11181978|NCT02071173|FG000|Participant Flow|NAVIGATE X4 Study Participants|"All subjects that signed the informed consent were included.~Subjects consent to undergo an implant procedure to receive at least one study device: ACUITY X4 LV lead, RELIANCE 4-FRONT RV lead. Each subject was allowed to be implanted with both leads.~ACUITY X4 quadripolar coronary venous lead: The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies.~RELIANCE 4-FRONT defibrillation lead: The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible ICD or CRT-D."
11181979|NCT02071173|OG000|Outcome|NAVIGATE X4 Study Participants|Subjects enrolled in the NAVIGATE X4 Study
11181980|NCT02071173|OG000|Outcome|RELIANCE 4-FRONT LEAD|RELIANCE 4-FRONT Endpoint Population
11181981|NCT02071173|EG000|Reported Event|NAVIGATE X4 Study Participants|All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200). Adverse events were not collected based on the lead implanted in the subject. All subjects were implanted or attempted with a CRT-D, Individual adverse event categories evaluated in participants at risk for that event category (2007 implanted/attempted with RA lead, 2090 with 4-FRONT, 2199 with any RV lead, 2162 with ACUITY X4, 2182 with any LV lead, 2019 with ACUITY X4 and/or 4-FRONT, 2019 with any lead).
11181982|NCT02071225|BG000|Baseline|Obinutuzumab + Bendamustine|Participants received obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles.
11181983|NCT02071225|FG000|Participant Flow|Obinutuzumab + Bendamustine|Participants received obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles.
11181984|NCT02071225|OG000|Outcome|Obinutuzumab + Bendamustine|Participants received obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles.
11181985|NCT02071225|EG000|Reported Event|Obinutuzumab + Bendamustine|Participants received obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles.
11181986|NCT02071290|BG000|Baseline|Sham Remote Ischemic Conditioning|Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
11181987|NCT02071290|BG001|Baseline|Remote Ischemic Conditioning|Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
11181988|NCT02071290|BG002|Baseline|Total|Total of all reporting groups
11181989|NCT02071290|FG000|Participant Flow|Sham Remote Ischemic Conditioning|Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
11181990|NCT02071290|FG001|Participant Flow|Remote Ischemic Conditioning|Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
11181991|NCT02071290|OG000|Outcome|Sham Remote Ischemic Conditioning|Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
11181992|NCT02071290|OG001|Outcome|Remote Ischemic Conditioning|Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
11181993|NCT02071290|EG000|Reported Event|Sham Remote Ischemic Conditioning|Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
11181994|NCT02071290|EG001|Reported Event|Remote Ischemic Conditioning|Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
11181995|NCT02071420|BG000|Baseline|Experimental Group|"This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.~Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
11181996|NCT02071420|BG001|Baseline|Active Control|"This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
11181997|NCT02071420|BG002|Baseline|Total|Total of all reporting groups
11181998|NCT02071420|FG000|Participant Flow|Experimental Group|"This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.~Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
11181999|NCT02071420|FG001|Participant Flow|Active Control|"This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
11182000|NCT02071420|OG000|Outcome|Experimental Group|"This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.~Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
11182001|NCT02071420|OG001|Outcome|Active Control|"This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
11191333|NCT02131766|OG001|Outcome|Sensor Augmented Pump Therapy|"The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods). The subject will follow their usual regimen. The subject will be asked to use the bolus calculator function on your insulin pump and enter the carbohydrate information that you eat during the week.~Sensor Augmented Pump Therapy: Insulin pump plus CGM."
11191334|NCT02131766|OG000|Outcome|USS Virginia Closed Loop Control|"The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs (CLC controller) and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast.~A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission."
11191335|NCT02131766|OG001|Outcome|Sensor Augmented Pump Therapy|"The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods).~Sensor Augmented Pump Therapy: Insulin pump plus CGM."
11191336|NCT02131766|EG000|Reported Event|USS Virginia Closed Loop Control and SAP|Combined Group in Cross-Over Trial that had CLC and SAP.
11191337|NCT02132117|BG000|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
11191338|NCT02132117|BG001|Baseline|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
11191339|NCT02132117|BG002|Baseline|Total|Total of all reporting groups
11191340|NCT02132117|FG000|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrochloride (HCL) Cream 1.0% applied to the face once daily for 29 days.
11191341|NCT02132117|FG001|Participant Flow|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
11191342|NCT02132117|OG000|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
11191343|NCT02132117|OG001|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
11191344|NCT02132117|EG000|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
11191345|NCT02132117|EG001|Reported Event|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
11191346|NCT02132130|BG000|Baseline|CGF166 Dose 20 μL|single dose volume #1
11191347|NCT02132130|BG001|Baseline|CGF166 Dose 30 μL|single dose volume #2
11191348|NCT02132130|BG002|Baseline|CGF166 Dose 40 μL|single dose volume #3
11191349|NCT02132130|BG003|Baseline|CGF166 Dose 60 μL|single dose volume #4
11191350|NCT02132130|BG004|Baseline|Total|Total of all reporting groups
11191351|NCT02132130|FG000|Participant Flow|CGF166 Dose 20 μL|single dose volume #1
11191352|NCT02132130|FG001|Participant Flow|CGF166 Dose 30 μL|single dose volume #2
11191353|NCT02132130|FG002|Participant Flow|CGF166 Dose 40 μL|single dose volume #3
11191354|NCT02132130|FG003|Participant Flow|CGF166 Dose 60 μL|single dose volume #4
11191355|NCT02132130|OG000|Outcome|CGF166 Dose 20 μL|single dose volume #1
11191356|NCT02132130|OG001|Outcome|CGF166 Dose 30 μLEdit Single Dose Volume #2|single dose #2
11191357|NCT02132130|OG002|Outcome|CGF166 Dose 40 μL|single dose volume #3
11191358|NCT02132130|OG003|Outcome|CGF166 Dose 60 μL|single dose volume #4
11191359|NCT02132130|OG004|Outcome|Total|Number of participants
11191360|NCT02132130|OG001|Outcome|CGF166 Dose 30 μL|single dose volume #2
11191361|NCT02132130|OG004|Outcome|Total|Number of AEs
11191362|NCT02132130|OG004|Outcome|Total|Total Number of participants
11191363|NCT02132130|EG000|Reported Event|CGF166 20 μL|CCGF166X2201 20 μL
11191364|NCT02132130|EG001|Reported Event|CGF166 30 μL|CCGF166X2201 30 μL
11191365|NCT02132130|EG002|Reported Event|CGF166 40 μL|CCGF166X2201 40 μL
11191366|NCT02132130|EG003|Reported Event|CGF166 60 μL|CCGF166X2201 60 μL
11191367|NCT02132169|BG000|Baseline|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
11191368|NCT02132169|BG001|Baseline|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
11191369|NCT02132169|BG002|Baseline|Total|Total of all reporting groups
11191370|NCT02132169|FG000|Participant Flow|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
11191371|NCT02132169|FG001|Participant Flow|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
11191372|NCT02132169|OG000|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
11191373|NCT02132169|OG001|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
11191374|NCT02132169|EG000|Reported Event|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
11191375|NCT02132169|EG001|Reported Event|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
11191376|NCT02132195|BG000|Baseline|Adrenocorticotropic Hormone (ACTH)|"Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2~The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose).~ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months."
11191377|NCT02132195|BG001|Baseline|No Treatment|Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. There is an option for the patient to elect to be placed in the active treatment arm of the trial (rescue therapy).
11191378|NCT02132195|BG002|Baseline|Rescue Therapy|There is an option for the patient in no-treatment arm to elect to be placed in the active treatment arm of the trial (rescue therapy).
11191379|NCT02132195|BG003|Baseline|Total|Total of all reporting groups
11191380|NCT02132195|FG000|Participant Flow|Adrenocorticotropic Hormone (ACTH)|"Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2~The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose).~ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months."
11182002|NCT02071420|EG000|Reported Event|Experimental Group|"This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.~Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
11182003|NCT02071420|EG001|Reported Event|Active Control|"This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
11182004|NCT02071706|BG000|Baseline|Single-Arm PET/MRI|"Single-group evaluation of PET/MRI for diagnostic quality of image~PET/MRI system: Enrolled subject undergoes PET/MR scan"
11182005|NCT02071706|FG000|Participant Flow|Single-Arm PET/MRI|"Single-group evaluation of PET/MRI for diagnostic quality of image~PET/MRI system: Enrolled subject undergoes PET/MR scan"
11182006|NCT02071706|OG000|Outcome|Single-Arm PET/MRI|"Single-group evaluation of PET/MRI for diagnostic quality of image~PET/MRI system: Enrolled subject undergoes PET/MR scan"
11182007|NCT02071706|EG000|Reported Event|Single-Arm PET/MRI|"Single-group evaluation of PET/MRI for diagnostic quality of image~PET/MRI system: Enrolled subject undergoes PET/MR scan"
11182008|NCT02071771|BG000|Baseline|Overall|Nelfilcon A and Etafilcon A toric contact lenses worn during Period 1 and Period 2, as randomized, in a crossover assignment.
11182009|NCT02071771|FG000|Participant Flow|DACP T, Then 1DAM A|Nelfilcon A toric contact lenses worn first, with Etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
11182010|NCT02071771|FG001|Participant Flow|1DAM A, Then DACP T|Etafilcon A toric contact lenses worn first, with Nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
11182011|NCT02071771|OG000|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
11182012|NCT02071771|OG001|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
11182013|NCT02071771|EG000|Reported Event|DACP T|Nelfilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
11182014|NCT02071771|EG001|Reported Event|1DAM A|Etafilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
11182015|NCT02071810|BG000|Baseline|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
11182016|NCT02071810|BG001|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
11182017|NCT02071810|BG002|Baseline|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
11182018|NCT02071810|BG003|Baseline|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
11182019|NCT02071810|BG004|Baseline|Placebo|"Placebo, PLC~Placebo"
11182020|NCT02071810|BG005|Baseline|Total|Total of all reporting groups
11182021|NCT02071810|FG000|Participant Flow|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
11182022|NCT02071810|FG001|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
11182023|NCT02071810|FG002|Participant Flow|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
11182024|NCT02071810|FG003|Participant Flow|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
11182025|NCT02071810|FG004|Participant Flow|Placebo|"Placebo, PLC~Placebo"
11182026|NCT02071810|OG000|Outcome|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
11182027|NCT02071810|OG001|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
11182028|NCT02071810|OG002|Outcome|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
11182029|NCT02071810|OG003|Outcome|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
11182030|NCT02071810|OG004|Outcome|Placebo|"Placebo, PLC~Placebo"
11182031|NCT02071810|EG000|Reported Event|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
11182032|NCT02071810|EG001|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
11182033|NCT02071810|EG002|Reported Event|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
11182034|NCT02071810|EG003|Reported Event|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
11182035|NCT02071810|EG004|Reported Event|Placebo|"Placebo, PLC~Placebo"
11182036|NCT02071823|BG000|Baseline|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fed Washout Period (7days) Period 2: Fasted~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
11182037|NCT02071823|BG001|Baseline|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fasted Washout Period (7days) Period 2: Fed~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
11182038|NCT02071823|BG002|Baseline|Total|Total of all reporting groups
11182039|NCT02071823|FG000|Participant Flow|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fed Washout Period (7days) Period 2: Fasted~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
11182040|NCT02071823|FG001|Participant Flow|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fasted Washout Period (7days) Period 2: Fed~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
11182041|NCT02071823|OG000|Outcome|Fasted Conditions|Fasted conditions period
11182042|NCT02071823|OG001|Outcome|Fed Condition|Fed condition period
11182043|NCT02071823|OG000|Outcome|Fed Conditions|Fed conditions period
11182044|NCT02071823|OG001|Outcome|Fasted Condition|Fasted condition period
11182045|NCT02071823|EG000|Reported Event|Fasted Conditions|Fasted conditions period
11182046|NCT02071823|EG001|Reported Event|Fed Condition|Fed condition period
11182047|NCT02071849|BG000|Baseline|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
11182048|NCT02071849|FG000|Participant Flow|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
11182049|NCT02071849|OG000|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
11182050|NCT02071849|EG000|Reported Event|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
11182051|NCT02071914|BG000|Baseline|CT-P27 10mg/kg|"CT-P27 will be administrated once in IV infusion.~CT-P27 10 mg/kg: Influenza A treatment drug."
11182052|NCT02071914|BG001|Baseline|CT-P27 20mg/kg|"CT-P27 will be administrated once in IV infusion.~CT-P27 20 mg/kg: Influenza A treatment drug."
11182053|NCT02071914|BG002|Baseline|Placebo|"Placebo will be administrated once in IV infusion.~Placebos: Placebo."
11182054|NCT02071914|BG003|Baseline|Total|Total of all reporting groups
11182055|NCT02071914|FG000|Participant Flow|CT-P27 10mg/kg|"CT-P27 will be administrated once in IV infusion.~CT-P27 10 mg/kg: Influenza A treatment drug."
11182056|NCT02071914|FG001|Participant Flow|CT-P27 20mg/kg|"CT-P27 will be administrated once in IV infusion.~CT-P27 20 mg/kg: Influenza A treatment drug."
11182057|NCT02071914|FG002|Participant Flow|Placebo|"Placebo will be administrated once in IV infusion.~Placebos: Placebo."
11182058|NCT02071914|OG000|Outcome|CT-P27 10mg/kg|"CT-P27 will be administrated once in IV infusion.~CT-P27 10 mg/kg: Influenza A treatment drug."
11182059|NCT02071914|OG001|Outcome|CT-P27 20mg/kg|"CT-P27 will be administrated once in IV infusion.~CT-P27 20 mg/kg: Influenza A treatment drug."
11182060|NCT02071914|OG002|Outcome|Placebo|"Placebo will be administrated once in IV infusion.~Placebos: Placebo."
11182061|NCT02071914|EG000|Reported Event|CT-P27 10mg/kg|"CT-P27 will be administrated once in IV infusion.~CT-P27 10 mg/kg: Influenza A treatment drug."
11182062|NCT02071914|EG001|Reported Event|CT-P27 20mg/kg|"CT-P27 will be administrated once in IV infusion.~CT-P27 20 mg/kg: Influenza A treatment drug."
11182063|NCT02071914|EG002|Reported Event|Placebo|"Placebo will be administrated once in IV infusion.~Placebos: Placebo."
11182064|NCT02072096|BG000|Baseline|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
11182065|NCT02072096|BG001|Baseline|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine dose is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
11182066|NCT02072096|BG002|Baseline|Total|Total of all reporting groups
11182067|NCT02072096|FG000|Participant Flow|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
11182068|NCT02072096|FG001|Participant Flow|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
11182069|NCT02072096|OG000|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
11182070|NCT02072096|OG001|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
11182071|NCT02072096|OG000|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
11182072|NCT02072096|EG000|Reported Event|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
11182073|NCT02072096|EG001|Reported Event|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
11182074|NCT02072174|BG000|Baseline|Anaferon for Children|Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182075|NCT02072174|BG001|Baseline|Placebo|Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182076|NCT02072174|BG002|Baseline|Total|Total of all reporting groups
11182077|NCT02072174|FG000|Participant Flow|Anaferon for Children|Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182078|NCT02072174|FG001|Participant Flow|Placebo|Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182079|NCT02072174|OG000|Outcome|Anaferon for Children|Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182080|NCT02072174|OG001|Outcome|Placebo|Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182081|NCT02072174|OG000|Outcome|Anaferon for Children|Anaferon for children: Anaferon for children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182082|NCT02072174|OG001|Outcome|Placebo|Placebo: Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182083|NCT02072174|EG000|Reported Event|Anaferon for Children|Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182084|NCT02072174|EG001|Reported Event|Placebo|Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
11182085|NCT02072200|BG000|Baseline|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
11182086|NCT02072200|FG000|Participant Flow|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
11182087|NCT02072200|OG000|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
11182088|NCT02072200|EG000|Reported Event|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
11182089|NCT02072226|BG000|Baseline|Alteplase + Aspirin Placebo|Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
11182090|NCT02072226|BG001|Baseline|Alteplase Placebo + Aspirin|Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
11182091|NCT02072226|BG002|Baseline|Total|Total of all reporting groups
11182092|NCT02072226|FG000|Participant Flow|Alteplase + Aspirin Placebo|Participants received single dose of 0.9 milligram per kilogram (mg/kg) (maximal dose of 90 mg) intravenous (IV) alteplase and aspirin placebo orally.
11182093|NCT02072226|FG001|Participant Flow|Alteplase Placebo + Aspirin|Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
11182094|NCT02072226|OG000|Outcome|Alteplase + Aspirin Placebo|Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
11182095|NCT02072226|OG001|Outcome|Alteplase Placebo + Aspirin|Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
11182096|NCT02072226|EG000|Reported Event|Alteplase + Aspirin Placebo|Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
11182097|NCT02072226|EG001|Reported Event|Alteplase Placebo + Aspirin|Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
11182098|NCT02072421|BG000|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
11182099|NCT02072421|FG000|Participant Flow|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
11182100|NCT02072421|OG000|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
11182101|NCT02072421|OG000|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
11182102|NCT02072421|EG000|Reported Event|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
11182103|NCT02072434|BG000|Baseline|Edoxaban|Participants randomized to receive Edoxaban
11182104|NCT02072434|BG001|Baseline|Warfarin|Participants randomized to receive Warfarin
11182105|NCT02072434|BG002|Baseline|Total|Total of all reporting groups
11182106|NCT02072434|FG000|Participant Flow|Edoxaban|Participants randomized to receive Edoxaban
11182107|NCT02072434|FG001|Participant Flow|Warfarin|Participants randomized to receive Warfarin
11182108|NCT02072434|OG000|Outcome|Edoxaban|Participants randomized to receive Edoxaban
11182109|NCT02072434|OG001|Outcome|Warfarin|Participants randomized to receive Warfarin
11182110|NCT02072434|EG000|Reported Event|Edoxaban|Participants randomized to receive Edoxaban
11182111|NCT02072434|EG001|Reported Event|Warfarin|Participants randomized to receive Warfarin
11182112|NCT02072668|BG000|Baseline|Study Participants|Participants who had a screening visit
11182113|NCT02072668|FG000|Participant Flow|Rivaroxaban, Then Placebo|"Participants first received Rivaroxaban 20 mg tablet once daily for 4 weeks. After a washout period of 2 weeks, they then received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks.~Rivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks"
11182114|NCT02072668|FG001|Participant Flow|Placebo, Then Rivaroxaban|"Participants first received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks. After a washout period of 2 weeks, they then received Rivaroxaban 20 mg tablet once daily for 4 weeks.~Rivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks"
11182115|NCT02072668|OG000|Outcome|Rivaroxaban|Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
11182116|NCT02072668|OG001|Outcome|Placebo|Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
11182117|NCT02072668|OG000|Outcome|Rivaroxaban, Then Placebo|"Participants first received Rivaroxaban 20 mg tablet once daily for 4 weeks. After a washout period of 2 weeks, they then received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks.~Rivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks"
11182118|NCT02072668|OG001|Outcome|Placebo, Then Rivaroxaban|"Participants first received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks. After a washout period of 2 weeks, they then received Rivaroxaban 20 mg tablet once daily for 4 weeks.~Rivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks"
11182119|NCT02072668|EG000|Reported Event|Rivaroxaban|Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
11182120|NCT02072668|EG001|Reported Event|Placebo|Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
11182121|NCT02072824|BG000|Baseline|Pregabalin 7 mg/kg/Day or 6 mg/kg/Day|Participants aged > 3 months to < 4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 5 days; followed by 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 7 days.
11182122|NCT02072824|BG001|Baseline|Pregabalin 14 mg/kg/Day or 12 mg/kg/Day|Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days.
11182123|NCT02072824|BG002|Baseline|Placebo|Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days.
11182124|NCT02072824|BG003|Baseline|Total|Total of all reporting groups
11182125|NCT02072824|FG000|Participant Flow|Pregabalin 7 mg/kg/Day or 6 mg/kg/Day|Participants aged greater than (>) 3 months to less than (<) 4 years, received Pregabalin 3.5 milligrams per kilogram per day (mg/kg/day) (3.0 mg/kg/day for participants 1 to 3 months of age), orally three times daily (TID) in equally divided doses for first 5 days; followed by 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 7 days.
11182126|NCT02072824|FG001|Participant Flow|Pregabalin 14 mg/kg/Day or 12 mg/kg/Day|Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days.
11182127|NCT02072824|FG002|Participant Flow|Placebo|Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days.
11182128|NCT02072824|OG000|Outcome|Pregabalin 7 mg/kg/Day or 6 mg/kg/Day|Participants aged > 3 months to < 4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 5 days; followed by 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 7 days.
11182129|NCT02072824|OG001|Outcome|Pregabalin 14 mg/kg/Day or 12 mg/kg/Day|Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days.
11182130|NCT02072824|OG002|Outcome|Placebo|Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days.
11182131|NCT02072824|EG000|Reported Event|Pregabalin 7 mg/kg/Day or 6 mg/kg/Day|Participants aged > 3 months to < 4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 5 days; followed by 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 7 days.
11182132|NCT02072824|EG001|Reported Event|Pregabalin 14 mg/kg/Day or 12 mg/kg/Day|Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days.
11182133|NCT02072824|EG002|Reported Event|Placebo|Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days.
11182134|NCT02072928|BG000|Baseline|BOTOX®|Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
11182135|NCT02072928|FG000|Participant Flow|BOTOX®|Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
11182136|NCT02072928|OG000|Outcome|BOTOX®|Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
11182137|NCT02072928|EG000|Reported Event|BOTOX®|Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
11182138|NCT02072941|BG000|Baseline|PREPARE Intervention|The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD). Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions. During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan.
11182139|NCT02072941|BG001|Baseline|Control|The control arm will review an easy-to-read AD. Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired. One to three days before a primary care visit, controls will receive a reminder to come to their appointment.
11182140|NCT02072941|BG002|Baseline|Total|Total of all reporting groups
11182141|NCT02072941|FG000|Participant Flow|PREPARE Intervention|The PREPARE arm reviewed the PREPARE website plus the easy-to-read advance directive (AD). While reviewing the PREPARE website, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants were given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, participants in the PREPARE arm received a reminder phone call to come to their primary care appointment and to bring their action plan.
11182142|NCT02072941|FG001|Participant Flow|Control|The control arm reviewed an easy-to-read advance directive (AD) and took the AD home to complete if desired. One to three days before a primary care visit, participants in the control arm received a reminder to come to their primary care appointment.
11182143|NCT02072941|OG000|Outcome|PREPARE Intervention|The PREPARE arm reviewed the PREPARE website plus the easy-to-read advance directive (AD). While reviewing the PREPARE website, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants were given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, participants in the PREPARE arm received a reminder phone call to come to their primary care appointment and to bring their action plan.
11182144|NCT02072941|OG001|Outcome|Control|The control arm reviewed an easy-to-read advance directive (AD) and took the AD home to complete if desired. One to three days before a primary care visit, participants in the control arm received a reminder to come to their primary care appointment.
11182145|NCT02072941|EG000|Reported Event|PREPARE Intervention|The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD). Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions. During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan.
11182146|NCT02072941|EG001|Reported Event|Control|The control arm will review an easy-to-read AD. Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired. One to three days before a primary care visit, controls will receive a reminder to come to their appointment.
11182147|NCT02072980|BG000|Baseline|Overall|Delefilcon A contact lenses worn during Period 1 and Period 2
11182148|NCT02072980|FG000|Participant Flow|16hr/15min|Delefilcon A contact lenses worn bilaterally for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.
11182149|NCT02072980|FG001|Participant Flow|15min/16hr|Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
11182150|NCT02072980|OG000|Outcome|16 Hours|Delefilcon A contact lenses worn for 16 hours in Period 1 or 2
11182151|NCT02072980|OG001|Outcome|Unworn|Unworn delefilcon A contact lenses removed from the commercial packaging and soaked overnight in phosphate buffered saline
11182152|NCT02072980|OG000|Outcome|15 Minutes|Delefilcon A contact lenses worn for 15 minutes during Period 1 or 2
11182153|NCT02072980|EG000|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn during Period 1 and Period 2
11182154|NCT02073162|BG000|Baseline|Liberal Group|"At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs~Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)"
11182155|NCT02073162|BG001|Baseline|Restrictive Group|"At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids~Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)"
11182156|NCT02073162|BG002|Baseline|Total|Total of all reporting groups
11182157|NCT02073162|FG000|Participant Flow|Liberal Group|"At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs~Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)"
11182158|NCT02073162|FG001|Participant Flow|Restrictive Group|"At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids~Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)"
11182159|NCT02073162|OG000|Outcome|Liberal Group|"At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs~Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)"
11182160|NCT02073162|OG001|Outcome|Restrictive Group|"At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids~Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)"
11182161|NCT02073162|EG000|Reported Event|Liberal Group|"At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs~Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)"
11182162|NCT02073162|EG001|Reported Event|Restrictive Group|"At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids~Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)"
11182163|NCT02073331|BG000|Baseline|CorMatrix ECM|Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
11182164|NCT02073331|FG000|Participant Flow|CorMatrix ECM|Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
11182165|NCT02073331|OG000|Outcome|CorMatrix ECM|Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
11182166|NCT02073331|EG000|Reported Event|CorMatrix ECM|Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
11182167|NCT02073435|BG000|Baseline|Post-Implementation Group|Living Donor Liver Transplant patients with evidence based donor pain management solution.
11182168|NCT02073435|BG001|Baseline|Pre-Implementation Group|Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
11182169|NCT02073435|BG002|Baseline|Total|Total of all reporting groups
11182170|NCT02073435|FG000|Participant Flow|Post-Implementation Group|Living Donor Liver Transplant patients with evidence based donor pain management solution.
11182171|NCT02073435|FG001|Participant Flow|Pre-Implementation Group|Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
11182172|NCT02073435|OG000|Outcome|Post-Implementation Group|Living Donor Liver Transplant patients with evidence based donor pain management solution.
11182173|NCT02073435|OG001|Outcome|Pre-Implementation Group|Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
11182174|NCT02073435|EG000|Reported Event|Post-Implementation Group|Living Donor Liver Transplant patients with evidence based donor pain management solution.
11182175|NCT02073435|EG001|Reported Event|Pre-Implementation Group|Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
11182176|NCT02073448|BG000|Baseline|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
11182177|NCT02073448|BG001|Baseline|CD0271|"Adapalene 01% Gel~CD0271"
11182178|NCT02073448|BG002|Baseline|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
11182179|NCT02073448|BG003|Baseline|Total|Total of all reporting groups
11182180|NCT02073448|FG000|Participant Flow|CD0271|"Adapalene 01% Gel~CD0271"
11182181|NCT02073448|FG001|Participant Flow|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
11182182|NCT02073448|FG002|Participant Flow|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
11182183|NCT02073448|OG000|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
11182184|NCT02073448|OG001|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
11182185|NCT02073448|OG002|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
11182186|NCT02073448|OG000|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
11182187|NCT02073448|OG001|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
11182188|NCT02073448|EG000|Reported Event|CD0271|"Adapalene 01% Gel~CD0271"
11182189|NCT02073448|EG001|Reported Event|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
11182190|NCT02073448|EG002|Reported Event|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
11182191|NCT02073461|BG000|Baseline|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
11182192|NCT02073461|BG001|Baseline|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
11182193|NCT02073461|BG002|Baseline|Vehicle|"Vehicle~Vehicle"
11182194|NCT02073461|BG003|Baseline|Total|Total of all reporting groups
11182195|NCT02073461|FG000|Participant Flow|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
11182196|NCT02073461|FG001|Participant Flow|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
11182197|NCT02073461|FG002|Participant Flow|Vehicle|"Vehicle~Vehicle"
11182198|NCT02073461|OG000|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
11182199|NCT02073461|OG001|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
11182200|NCT02073461|OG002|Outcome|Vehicle|"Vehicle~Vehicle"
11182201|NCT02073461|EG000|Reported Event|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
11182202|NCT02073461|EG001|Reported Event|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
11182203|NCT02073461|EG002|Reported Event|Vehicle|"Vehicle~Vehicle"
11182204|NCT02073487|BG000|Baseline|T-DM1 + Lapatinib + Abraxane|"T-DM1 intravenously (IV) every three weeks plus Lapatinib orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.~T-DM1: antibody-drug conjugate of trastuzumab and emtansine~Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)~Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor."
11182205|NCT02073487|BG001|Baseline|Trastuzumab + Pertuzumab + Paclitaxel|"Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.~Trastuzumab: anti-Her2 monoclonal antibody~Paclitaxel: chemotherapy - microtubule inhibitor~Pertuzumab: anti-HER2 monoclonal antibody"
11182206|NCT02073487|BG002|Baseline|Total|Total of all reporting groups
11182207|NCT02073487|FG000|Participant Flow|T-DM1 + Lapatinib + Abraxane|"T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.~T-DM1: antibody-drug conjugate of trastuzumab and emtansine~Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)~Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor."
11182208|NCT02073487|FG001|Participant Flow|Trastuzumab + Pertuzumab + Paclitaxel|"Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.~Trastuzumab: anti-Her2 monoclonal antibody~Paclitaxel: chemotherapy - microtubule inhibitor~Pertuzumab: anti-HER2 monoclonal antibody"
11182209|NCT02073487|OG000|Outcome|T-DM1 + Lapatinib + Abraxane|"T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.~T-DM1: antibody-drug conjugate of trastuzumab and emtansine~Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)~Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor."
11182210|NCT02073487|OG001|Outcome|Trastuzumab + Pertuzumab + Paclitaxel|"Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.~Trastuzumab: anti-Her2 monoclonal antibody~Paclitaxel: chemotherapy - microtubule inhibitor~Pertuzumab: anti-HER2 monoclonal antibody"
11182211|NCT02073487|OG000|Outcome|Trastuzumab + Pertuzumab + Paclitaxel|"Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.~Trastuzumab: anti-Her2 monoclonal antibody~Paclitaxel: chemotherapy - microtubule inhibitor~Pertuzumab: anti-HER2 monoclonal antibody"
11182212|NCT02073487|EG000|Reported Event|T-DM1 + Lapatinib + Abraxane|"T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.~T-DM1: antibody-drug conjugate of trastuzumab and emtansine~Lapatinib: Dual tyrosine kinase inhibitor (HER2 and EGFR)~Abraxane: albumin-bound paclitaxel. chemotherapy - microtubule inhibitor."
11182213|NCT02073487|EG001|Reported Event|Trastuzumab + Pertuzumab + Paclitaxel|"Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.~Trastuzumab: anti-Her2 monoclonal antibody~Paclitaxel: chemotherapy - microtubule inhibitor~Pertuzumab: anti-HER2 monoclonal antibody"
11182214|NCT02073643|BG000|Baseline|Main Cohort|This is a cohort study.
11182215|NCT02073643|FG000|Participant Flow|Main Food Purchasing Cohort|This is a cohort study.
11182216|NCT02073643|OG000|Outcome|Main Cohort|This is a cohort study.
11182217|NCT02073643|EG000|Reported Event|Main Cohort|This is a cohort study.
11182218|NCT02073656|BG000|Baseline|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
11182219|NCT02073656|FG000|Participant Flow|LDV/SOF 12 Weeks|"Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.~Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks."
11182220|NCT02073656|OG000|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
11182221|NCT02073656|OG000|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
11182222|NCT02073656|EG000|Reported Event|LDV/SOF 12 Weeks (Primary Study)|LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
11182223|NCT02073656|EG001|Reported Event|LDV/SOF+RBV 24 Weeks (Retreatment)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
11182224|NCT02073682|BG000|Baseline|Edoxaban Group|After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
11182225|NCT02073682|BG001|Baseline|Dalteparin Group|Participants received dalteparin daily
11182226|NCT02073682|BG002|Baseline|Total|Total of all reporting groups
11182227|NCT02073682|FG000|Participant Flow|Edoxaban Group|After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
11182228|NCT02073682|FG001|Participant Flow|Dalteparin Group|Participants received dalteparin daily
11182229|NCT02073682|OG000|Outcome|Edoxaban Group|After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
11182230|NCT02073682|OG001|Outcome|Dalteparin Group|Participants received dalteparin daily
11182231|NCT02073682|EG000|Reported Event|Edoxaban Group|After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
11182232|NCT02073682|EG001|Reported Event|Dalteparin Group|Participants received dalteparin daily
11182233|NCT02073747|BG000|Baseline|Albuterol|Study group
11182234|NCT02073747|BG001|Baseline|Normal Saline|Control group
11182235|NCT02073747|BG002|Baseline|Total|Total of all reporting groups
11182236|NCT02073747|FG000|Participant Flow|Normal Saline Control Group|"Control group will be administered a one hour normal saline inhaled treatment.~Normal Saline: One hour inhaled normal saline"
11182237|NCT02073747|FG001|Participant Flow|Albuterol Trial Group|"Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol~Albuterol: One hour inhaled ten milligrams of albuterol"
11182238|NCT02073747|OG000|Outcome|Normal Saline Control Group|"Control group will be administered a one hour normal saline inhaled treatment.~Normal Saline: One hour inhaled normal saline"
11182239|NCT02073747|OG001|Outcome|Albuterol Trial Group|"Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol~Albuterol: One hour inhaled ten milligrams of albuterol"
11182240|NCT02073747|EG000|Reported Event|Albuterol|Study group; 10 mg of nebulizer albuterol
11182241|NCT02073747|EG001|Reported Event|Normal Saline|Control group
11182242|NCT02073929|BG000|Baseline|Liraglutide|Liraglutide
11182243|NCT02073929|BG001|Baseline|Placebo|Placebo
11182244|NCT02073929|BG002|Baseline|Total|Total of all reporting groups
11182245|NCT02073929|FG000|Participant Flow|Liraglutide|"Liraglutide s.c. 1,8mg daily for 26 weeks~Liraglutide: GLP-1-analogue Liraglutide"
11182246|NCT02073929|FG001|Participant Flow|Placebo|"Placebo s.c. 1,8mg daily for 26 weeks~placebo"
11182247|NCT02073929|OG000|Outcome|Liraglutide|"Liraglutide s.c. 1,8mg daily for 26 weeks~Liraglutide: GLP-1-analogue Liraglutide"
11182248|NCT02073929|OG001|Outcome|Placebo|"Placebo s.c. 1,8mg daily for 26 weeks~placebo"
11182249|NCT02073929|EG000|Reported Event|Active|"Liraglutide s.c. 1,8mg daily for 26 weeks~Liraglutide: GLP-1-analogue Liraglutide"
11182250|NCT02073929|EG001|Reported Event|Placebo|"Placebo s.c. 1,8mg daily for 26 weeks~placebo"
11182251|NCT02074059|BG000|Baseline|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of lucinactant for inhalation with nCPAP
11182252|NCT02074059|BG001|Baseline|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of lucinactant for inhalation with nCPAP
11182253|NCT02074059|BG002|Baseline|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of lucinactant for inhalation with nCPAP
11182254|NCT02074059|BG003|Baseline|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
11182255|NCT02074059|BG004|Baseline|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
11182256|NCT02074059|BG005|Baseline|nCPAP Alone|nCPAP therapy alone
11182257|NCT02074059|BG006|Baseline|Total|Total of all reporting groups
11182258|NCT02074059|FG000|Participant Flow|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182259|NCT02074059|FG001|Participant Flow|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182260|NCT02074059|FG002|Participant Flow|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182261|NCT02074059|FG003|Participant Flow|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
11182262|NCT02074059|FG004|Participant Flow|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
11182263|NCT02074059|FG005|Participant Flow|nCPAP Alone|"nCPAP therapy alone~nCPAP alone: nCPAP therapy"
11182264|NCT02074059|OG000|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182265|NCT02074059|OG001|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182266|NCT02074059|OG002|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182267|NCT02074059|OG003|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
11182268|NCT02074059|OG004|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
11182269|NCT02074059|OG005|Outcome|nCPAP Alone|nCPAP therapy alone
11182270|NCT02074059|OG002|Outcome|Aerosolized Lucinactant (High Dose)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182271|NCT02074059|EG000|Reported Event|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182272|NCT02074059|EG001|Reported Event|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182273|NCT02074059|EG002|Reported Event|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
11182274|NCT02074059|EG003|Reported Event|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
11182275|NCT02074059|EG004|Reported Event|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
11182276|NCT02074059|EG005|Reported Event|nCPAP Alone|nCPAP therapy alone
11182277|NCT02074345|BG000|Baseline|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
11182278|NCT02074345|FG000|Participant Flow|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
11182279|NCT02074345|OG000|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
11182280|NCT02074345|EG000|Reported Event|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
11182281|NCT02074358|BG000|Baseline|All Treated Participants|Treated population included all participants who received at least one dose of study medication. Participants received 10 mg apixaban BID on Days 1-3 and on Day 4 received a single dose of 10 mg apixaban followed 3 hours later by an IV infusion of 50 IU/kg prothrombin complex concentrate (PCC) (which was either Cofact or Beriplex P/N) or the participant received an IV infusion of placebo (saline solution). Participants were randomized on Day 1 to one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB and CBA). There were 3 treatment periods with a total of 3 participants in each of 3 sequences (ABC, ACB, CAB) and 2 participants in each of 3 other sequences (CBA, BAC, BCA) for a total of 15 participants who participated in this open label, randomized, crossover study.
11182282|NCT02074358|FG000|Participant Flow|Treatment ABC|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID) on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours (hrs) later by Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) intravenous infusion (IV) for 30 minutes.~Treatment B: Apixaban + Cofact [4-Factor prothrombin complex concentrate (PCC)]: Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 min."
11191381|NCT02132195|FG001|Participant Flow|No Treatment|Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. There is an option for the patient to elect to be placed in the active treatment arm of the trial (rescue therapy).
11182283|NCT02074358|FG001|Participant Flow|Treatment ACB|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
11182284|NCT02074358|FG002|Participant Flow|Treatment BAC|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
11182285|NCT02074358|FG003|Participant Flow|Treatment BCA|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
11182286|NCT02074358|FG004|Participant Flow|Treatment CAB|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
11182287|NCT02074358|FG005|Participant Flow|Treatment CBA|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
11182288|NCT02074358|OG000|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
11182289|NCT02074358|OG001|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
11182290|NCT02074358|OG002|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
11182291|NCT02074358|EG000|Reported Event|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
11182292|NCT02074358|EG001|Reported Event|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
11182293|NCT02074358|EG002|Reported Event|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
11182294|NCT02074384|BG000|Baseline|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
11182295|NCT02074384|BG001|Baseline|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
11182296|NCT02074384|BG002|Baseline|Clinicians|Clinicians completing the study visits.
11182297|NCT02074384|BG003|Baseline|Total|Total of all reporting groups
11182298|NCT02074384|FG000|Participant Flow|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
11182299|NCT02074384|FG001|Participant Flow|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
11182300|NCT02074384|FG002|Participant Flow|Clinicians|Clinicians completing study AGP visits.
11182301|NCT02074384|OG000|Outcome|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
11182302|NCT02074384|OG001|Outcome|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
11182303|NCT02074384|OG002|Outcome|Clinicians|Clinicians completing the study visits.
11235182|NCT02440594|EG000|Reported Event|Enhanced Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235183|NCT02440594|EG001|Reported Event|Standard Care High-Symptom AD/AX|Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235184|NCT02440594|EG002|Reported Event|Enhanced Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/ BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.
11235185|NCT02440594|EG003|Reported Event|Standard Monitoring Low-Symptom AD/AX/AP|Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235186|NCT02440594|EG004|Reported Event|Enhanced Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.
11235187|NCT02440594|EG005|Reported Event|Standard Care High-Symptom AP|Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
11235188|NCT02440594|EG006|Reported Event|Caregiver TEP Intervention|Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training.
11235189|NCT02440594|EG007|Reported Event|Caregiver Control|Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services
11235190|NCT02440633|BG000|Baseline|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
11235191|NCT02440633|FG000|Participant Flow|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
11235192|NCT02440633|OG000|Outcome|Feces|
11235193|NCT02440633|OG001|Outcome|Urine|
11235194|NCT02440633|OG002|Outcome|Total|
11235195|NCT02440633|OG000|Outcome|Plasma|
11235196|NCT02440633|OG001|Outcome|Whole Blood|
11235197|NCT02440633|EG000|Reported Event|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
11235198|NCT02440659|BG000|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
11235199|NCT02440659|BG001|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
11235200|NCT02440659|BG002|Baseline|Total|Total of all reporting groups
11235201|NCT02440659|FG000|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
11235202|NCT02440659|FG001|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
11235203|NCT02440659|OG000|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
11235204|NCT02440659|OG001|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
11235205|NCT02440659|EG000|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
11235206|NCT02440659|EG001|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
11235207|NCT02440789|BG000|Baseline|Sirolimus|"Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.~Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.~Sirolimus"
11235208|NCT02440789|FG000|Participant Flow|Sirolimus|"Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.~Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks."
11235209|NCT02440789|OG000|Outcome|Sirolimus|"Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.~Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks."
11235210|NCT02440789|EG000|Reported Event|Sirolimus|Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks. Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
11235211|NCT02441062|BG000|Baseline|68Ga-DOTATOC PET/CT|"Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.~68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors"
11235212|NCT02441062|FG000|Participant Flow|68Ga-DOTATOC PET/CT|"Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.~68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors"
11235213|NCT02441062|OG000|Outcome|68Ga-DOTATOC PET/CT|"Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.~68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors"
11235214|NCT02441062|EG000|Reported Event|68Ga-DOTATOC PET/CT|"Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.~68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors"
11235215|NCT02441114|BG000|Baseline|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
11235216|NCT02441114|FG000|Participant Flow|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
11235217|NCT02441114|OG000|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
11235218|NCT02441114|EG000|Reported Event|HCP0910 and HGP1011|"Single Inhalation of HCP0910 and HGP1011 (Open-label, Single-arm, Single dosing, Dose-escalation)~HCP0910 and HGP1011: Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))"
11235219|NCT02441179|BG000|Baseline|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
11235220|NCT02441179|BG001|Baseline|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
11235221|NCT02441179|BG002|Baseline|Total|Total of all reporting groups
11235222|NCT02441179|FG000|Participant Flow|Acute Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
11182304|NCT02074384|EG000|Reported Event|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
11182305|NCT02074384|EG001|Reported Event|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
11182306|NCT02074384|EG002|Reported Event|Clinicians|"Clinicians completing study visits.~Clinician: Survey of clinicians after study visits"
11182307|NCT02074514|BG000|Baseline|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
11182308|NCT02074514|BG001|Baseline|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
11182309|NCT02074514|BG002|Baseline|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
11182310|NCT02074514|BG003|Baseline|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
11182311|NCT02074514|BG004|Baseline|Total|Total of all reporting groups
11182312|NCT02074514|FG000|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 16 weeks.
11182313|NCT02074514|FG001|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks.
11182314|NCT02074514|OG000|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
11182315|NCT02074514|OG001|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
11182316|NCT02074514|OG002|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
11182317|NCT02074514|OG003|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
11182318|NCT02074514|OG000|Outcome|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
11182319|NCT02074514|OG001|Outcome|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11182320|NCT02074514|EG000|Reported Event|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
11182321|NCT02074514|EG001|Reported Event|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11182322|NCT02074553|BG000|Baseline|Part 1 (Fasted): Study Population|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 1 of the study.
11182323|NCT02074553|BG001|Baseline|Part 2 (Fed): Study Population|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 2 of the study.
11182324|NCT02074553|BG002|Baseline|Total|Total of all reporting groups
11182325|NCT02074553|FG000|Participant Flow|Part 1 (Fasted): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours received 600 milligram (mg) of alectinib (RO5424802) as a capsule formulation (four 150 mg capsules) orally in Part 1 of the study according to following treatment sequences. Treatment A (Reference Treatment: formulation containing 50 percent [%]sodium lauryl sulfate [SLS]) on Day 1 of the first intervention period; then Treatment B (Test Treatment: formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (Test Treatment: formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (Test Treatment: formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
11182326|NCT02074553|FG001|Participant Flow|Part 1 (Fasted): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
11182327|NCT02074553|FG002|Participant Flow|Part 1 (Fasted): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
11191382|NCT02132195|FG002|Participant Flow|Rescue Therapy|"Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.~Other Names: Acthar Adrenocorticotropic hormone"
11182328|NCT02074553|FG003|Participant Flow|Part 1 (Fasted): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
11182329|NCT02074553|FG004|Participant Flow|Part 2 (Fed): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment A (formulation containing 50% SLS) on Day 1 of the first intervention period; then Treatment B (formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
11182330|NCT02074553|FG005|Participant Flow|Part 2 (Fed): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
11182331|NCT02074553|FG006|Participant Flow|Part 2 (Fed): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
11182332|NCT02074553|FG007|Participant Flow|Part 2 (Fed): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
11182333|NCT02074553|OG000|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
11182334|NCT02074553|OG001|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
11182335|NCT02074553|OG002|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
11182336|NCT02074553|OG003|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
11182337|NCT02074553|OG004|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
11182338|NCT02074553|OG005|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
11182339|NCT02074553|OG006|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
11182340|NCT02074553|OG007|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
11182341|NCT02074553|EG000|Reported Event|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
11182342|NCT02074553|EG001|Reported Event|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
11182343|NCT02074553|EG002|Reported Event|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
11182344|NCT02074553|EG003|Reported Event|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
11182345|NCT02074553|EG004|Reported Event|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
11182346|NCT02074553|EG005|Reported Event|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
11182347|NCT02074553|EG006|Reported Event|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
11182348|NCT02074553|EG007|Reported Event|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
11182349|NCT02074709|BG000|Baseline|TAP Block|TAP block with plain bupivacaine
11182350|NCT02074709|BG001|Baseline|Wound Infiltration|Wound infiltration with liposomal bupivacaine
11182351|NCT02074709|BG002|Baseline|Total|Total of all reporting groups
11182352|NCT02074709|FG000|Participant Flow|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
11182353|NCT02074709|FG001|Participant Flow|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
11182354|NCT02074709|OG000|Outcome|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV ."
11182355|NCT02074709|OG001|Outcome|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV"
11182356|NCT02074709|EG000|Reported Event|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
11182357|NCT02074709|EG001|Reported Event|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
11182358|NCT02074735|BG000|Baseline|Placebo|Placebo schedule will mimic the schedule of the active comparator citicoline. Placebo will be started at the randomization visit (week 0, mimicking 500 mg/day of citicoline), then increased at week 2 to mimic 1000 mg/day citicoline, then increased to mimic 1500 mg/day of citicoline at week 4, and then increased to mimic 2000 mg/day of citicoline at week 6 until the end of week 12.
11182359|NCT02074735|BG001|Baseline|Citicoline|Citicoline will be started at 500 mg/day at the randomization visit (week 0), then increased to 1000 mg/day at week 2, then 1500 mg/day at week 4, and then 2000 mg/day at week 6 until the end of week 12.
11182360|NCT02074735|BG002|Baseline|Total|Total of all reporting groups
11182361|NCT02074735|FG000|Participant Flow|Placebo|Placebo schedule will mimic the schedule of the active comparator citicoline. Placebo will be started at the randomization visit (week 0, mimicking 500 mg/day of citicoline), then increased at week 2 to mimic 1000 mg/day citicoline, then increased to mimic 1500 mg/day of citicoline at week 4, and then increased to mimic 2000 mg/day of citicoline at week 6 until the end of week 12.
11182362|NCT02074735|FG001|Participant Flow|Citicoline|Citicoline will be started at 500 mg/day at the randomization visit (week 0), then increased to 1000 mg/day at week 2, then 1500 mg/day at week 4, and then 2000 mg/day at week 6 until the end of week 12.
11182363|NCT02074735|OG000|Outcome|Placebo|Placebo schedule will mimic the schedule of the active comparator citicoline. Placebo will be started at the randomization visit (week 0, mimicking 500 mg/day of citicoline), then increased at week 2 to mimic 1000 mg/day citicoline, then increased to mimic 1500 mg/day of citicoline at week 4, and then increased to mimic 2000 mg/day of citicoline at week 6 until the end of week 12.
11182364|NCT02074735|OG001|Outcome|Citicoline|Citicoline will be started at 500 mg/day at the randomization visit (week 0), then increased to 1000 mg/day at week 2, then 1500 mg/day at week 4, and then 2000 mg/day at week 6 until the end of week 12.
11182365|NCT02074735|EG000|Reported Event|Placebo|Placebo schedule will mimic the schedule of the active comparator citicoline. Placebo will be started at the randomization visit (week 0, mimicking 500 mg/day of citicoline), then increased at week 2 to mimic 1000 mg/day citicoline, then increased to mimic 1500 mg/day of citicoline at week 4, and then increased to mimic 2000 mg/day of citicoline at week 6 until the end of week 12.
11182366|NCT02074735|EG001|Reported Event|Citicoline|Citicoline will be started at 500 mg/day at the randomization visit (week 0), then increased to 1000 mg/day at week 2, then 1500 mg/day at week 4, and then 2000 mg/day at week 6 until the end of week 12.
11182367|NCT02074982|BG000|Baseline|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
11182368|NCT02074982|BG001|Baseline|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
11182369|NCT02074982|BG002|Baseline|Total|Total of all reporting groups
11182370|NCT02074982|FG000|Participant Flow|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
11182371|NCT02074982|FG001|Participant Flow|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
11182372|NCT02074982|OG000|Outcome|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
11182373|NCT02074982|OG001|Outcome|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
11182374|NCT02074982|EG000|Reported Event|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
11182375|NCT02074982|EG001|Reported Event|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
11182376|NCT02074995|BG000|Baseline|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
11182377|NCT02074995|FG000|Participant Flow|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
11182378|NCT02074995|FG001|Participant Flow|Placebo Group 1B/1C, 2, 3, 4|
11182379|NCT02074995|FG002|Participant Flow|BVS857 Group 1B/1C, 2, 3, 4 Double Blind|
11182380|NCT02074995|OG000|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
11182381|NCT02074995|EG000|Reported Event|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
11182382|NCT02075008|BG000|Baseline|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
11182383|NCT02075008|FG000|Participant Flow|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
11182384|NCT02075008|OG000|Outcome|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
11182385|NCT02075008|EG000|Reported Event|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
11182386|NCT02075047|BG000|Baseline|Ziprasidone|Participants were randomized to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Participants with body weight less than 45 kilogram (kg) received 60 to 80 milligram per day (mg/day) and participants with body weight greater than or equal to (>=) 45 kg received 120 to 160 mg/day, as per investigator discretion. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726).
11182387|NCT02075047|BG001|Baseline|Placebo|Participants were randomized to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726).
11182388|NCT02075047|BG002|Baseline|Total|Total of all reporting groups
11182389|NCT02075047|FG000|Participant Flow|Ziprasidone|Participants were randomized to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Participants with body weight less than 45 kilogram (kg) received 60 to 80 milligram per day (mg/day) and participants with body weight greater than or equal to (>=) 45 kg received 120 to 160 mg/day, as per investigator discretion. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726).
11182390|NCT02075047|FG001|Participant Flow|Placebo|Participants were randomized to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726).
11182391|NCT02075047|OG000|Outcome|Ziprasidone|Participants were randomized to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Participants with body weight less than 45 kilogram (kg) received 60 to 80 milligram per day (mg/day) and participants with body weight greater than or equal to (>=) 45 kg received 120 to 160 mg/day, as per investigator discretion. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726).
11182392|NCT02075047|OG001|Outcome|Placebo|Participants were randomized to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726).
11182393|NCT02075047|EG000|Reported Event|Ziprasidone|Participants were randomized to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Participants with body weight less than 45 kilogram (kg) received 60 to 80 milligram per day (mg/day) and participants with body weight greater than or equal to (>=) 45 kg received 120 to 160 mg/day, as per investigator discretion. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726).
11182394|NCT02075047|EG001|Reported Event|Placebo|Participants were randomized to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726).
11182395|NCT02075073|BG000|Baseline|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
11182396|NCT02075073|BG001|Baseline|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
11182397|NCT02075073|BG002|Baseline|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
11182398|NCT02075073|BG003|Baseline|Total|Total of all reporting groups
11182399|NCT02075073|FG000|Participant Flow|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
11182400|NCT02075073|FG001|Participant Flow|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
11182401|NCT02075073|FG002|Participant Flow|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
11182402|NCT02075073|OG000|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
11182403|NCT02075073|OG001|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
11182404|NCT02075073|OG002|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
11182405|NCT02075073|EG000|Reported Event|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
11182406|NCT02075073|EG001|Reported Event|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
11182407|NCT02075073|EG002|Reported Event|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
11182408|NCT02075125|BG000|Baseline|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
11182409|NCT02075125|BG001|Baseline|Ticagrelor|Patients administer Ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
11182410|NCT02075125|BG002|Baseline|Total|Total of all reporting groups
11182411|NCT02075125|FG000|Participant Flow|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
11182412|NCT02075125|FG001|Participant Flow|Ticagrelor|Patient administer Ticagrelor 180 mg as loading dose followed by 90 mg twice a day as maintenance dose.
11182413|NCT02075125|OG000|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
11182414|NCT02075125|OG001|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
11182415|NCT02075125|EG000|Reported Event|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
11182416|NCT02075125|EG001|Reported Event|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
11182417|NCT02075203|BG000|Baseline|AERAS-404 (15 mcgH4/500 Nmol IC31)|"2 doses on Study Days 0 and 56~AERAS-404: The H4 antigen is a fusion protein created from two Mtb antigens: antigen Ag85B and TB10.4. Ag85B is also referred to as α-antigen and is a 30-kDa mycolyl transferase protein. TB10.4 is one of three members of the very similar ESAT-6 group of proteins found in Mtb culture supernatants. TB10.4 induces broad immune responses in T cells isolated from TB subjects compared to BCG-vaccinated donors and unvaccinated donors. IC31 is a combination of a leucine-rich peptide named KLK & a synthetic oligonucleotide named ODN1a. The optimal molar ratio of KLK to ODN1a in mice is 25:1. AERAS-404 & saline placebo trial arms will be double-blinded since BCG causes a recognizable local injection site reaction, the BCG revaccination trial arm will be unblinded."
11182418|NCT02075203|BG001|Baseline|Bacillus Calmette-Guérin (BCG)|"1 Dose on Study Day 0~Bacillus Calmette-Guérin (BCG): BCG SSI Vaccine is registered in South Africa for prevention of TB in children and adults. BCG, an attenuated, live culture of the Bacillus Calmette-Guérin, was originally attenuated between 1906 and 1919 by serial passage of an M. bovis strain. The manufacturer Statens Serum Institut (SSI) in Copenhagen, Denmark derives this vaccine from the Danish BCG strain 1331. BCG SSI is supplied by the manufacturer in amber 10-dose vials containing 0.75 mg lyophilized SSI BCG. The BCG revaccination trial arm will be unblinded (open label)."
11182419|NCT02075203|BG002|Baseline|Placebo|"2 Doses on Study Days 0 and 56~Placebo: Saline"
11182420|NCT02075203|BG003|Baseline|Total|Total of all reporting groups
11182421|NCT02075203|FG000|Participant Flow|AERAS-404 (15 mcgH4/500 Nmol IC31)|"2 doses on Study Days 0 and 56~AERAS-404: The H4 antigen is a fusion protein created from two Mtb antigens: antigen Ag85B and TB10.4. Ag85B is also referred to as α-antigen and is a 30-kDa mycolyl transferase protein. TB10.4 is one of three members of the very similar ESAT-6 group of proteins found in Mtb culture supernatants. TB10.4 induces broad immune responses in T cells isolated from TB subjects compared to BCG-vaccinated donors and unvaccinated donors. IC31 is a combination of a leucine-rich peptide named KLK & a synthetic oligonucleotide named ODN1a. The optimal molar ratio of KLK to ODN1a in mice is 25:1. AERAS-404 & saline placebo trial arms will be double-blinded since BCG causes a recognizable local injection site reaction, the BCG revaccination trial arm will be unblinded."
11182422|NCT02075203|FG001|Participant Flow|Bacillus Calmette-Guérin (BCG)|"1 Dose on Study Day 0~Bacillus Calmette-Guérin (BCG): BCG SSI Vaccine is registered in South Africa for prevention of TB in children and adults. BCG, an attenuated, live culture of the Bacillus Calmette-Guérin, was originally attenuated between 1906 and 1919 by serial passage of an M. bovis strain. The manufacturer Statens Serum Institut (SSI) in Copenhagen, Denmark derives this vaccine from the Danish BCG strain 1331. BCG SSI is supplied by the manufacturer in amber 10-dose vials containing 0.75 mg lyophilized SSI BCG. The BCG revaccination trial arm will be unblinded (open label)."
11182423|NCT02075203|FG002|Participant Flow|Placebo|"2 Doses on Study Days 0 and 56~Placebo: Saline"
11182424|NCT02075203|OG000|Outcome|AERAS-404 (15 mcgH4/500 Nmol IC31)|"2 doses on Study Days 0 and 56~AERAS-404: The H4 antigen is a fusion protein created from two Mtb antigens: antigen Ag85B and TB10.4. Ag85B is also referred to as α-antigen and is a 30-kDa mycolyl transferase protein. TB10.4 is one of three members of the very similar ESAT-6 group of proteins found in Mtb culture supernatants. TB10.4 induces broad immune responses in T cells isolated from TB subjects compared to BCG-vaccinated donors and unvaccinated donors. IC31 is a combination of a leucine-rich peptide named KLK & a synthetic oligonucleotide named ODN1a. The optimal molar ratio of KLK to ODN1a in mice is 25:1. AERAS-404 & saline placebo trial arms will be double-blinded since BCG causes a recognizable local injection site reaction, the BCG revaccination trial arm will be unblinded."
11182425|NCT02075203|OG001|Outcome|Bacillus Calmette-Guérin (BCG)|"1 Dose on Study Day 0~Bacillus Calmette-Guérin (BCG): BCG SSI Vaccine is registered in South Africa for prevention of TB in children and adults. BCG, an attenuated, live culture of the Bacillus Calmette-Guérin, was originally attenuated between 1906 and 1919 by serial passage of an M. bovis strain. The manufacturer Statens Serum Institut (SSI) in Copenhagen, Denmark derives this vaccine from the Danish BCG strain 1331. BCG SSI is supplied by the manufacturer in amber 10-dose vials containing 0.75 mg lyophilized SSI BCG. The BCG revaccination trial arm will be unblinded (open label)."
11182426|NCT02075203|OG002|Outcome|Placebo|"2 Doses on Study Days 0 and 56~Placebo: Saline"
11182427|NCT02075203|EG000|Reported Event|AERAS-404 (15 mcgH4/500 Nmol IC31)|"2 doses on Study Days 0 and 56~AERAS-404: The H4 antigen is a fusion protein created from two Mtb antigens: antigen Ag85B and TB10.4. Ag85B is also referred to as α-antigen and is a 30-kDa mycolyl transferase protein. TB10.4 is one of three members of the very similar ESAT-6 group of proteins found in Mtb culture supernatants. TB10.4 induces broad immune responses in T cells isolated from TB subjects compared to BCG-vaccinated donors and unvaccinated donors. IC31 is a combination of a leucine-rich peptide named KLK & a synthetic oligonucleotide named ODN1a. The optimal molar ratio of KLK to ODN1a in mice is 25:1. AERAS-404 & saline placebo trial arms will be double-blinded since BCG causes a recognizable local injection site reaction, the BCG revaccination trial arm will be unblinded."
11182428|NCT02075203|EG001|Reported Event|Bacillus Calmette-Guerin (BCG)|"1 Dose on Study Day 0~Bacillus Calmette-Guérin (BCG): BCG SSI Vaccine is registered in South Africa for prevention of TB in children and adults. BCG, an attenuated, live culture of the Bacillus Calmette-Guérin, was originally attenuated between 1906 and 1919 by serial passage of an M. bovis strain. The manufacturer Statens Serum Institut (SSI) in Copenhagen, Denmark derives this vaccine from the Danish BCG strain 1331. BCG SSI is supplied by the manufacturer in amber 10-dose vials containing 0.75 mg lyophilized SSI BCG. The BCG revaccination trial arm will be unblinded (open label)."
11182429|NCT02075203|EG002|Reported Event|Placebo|"2 Doses on Study Days 0 and 56~Placebo: Saline"
11182430|NCT02075255|BG000|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11182431|NCT02075255|BG001|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
11182432|NCT02075255|BG002|Baseline|Placebo|Placebo administered subcutaneously
11182433|NCT02075255|BG003|Baseline|Total|Total of all reporting groups
11182434|NCT02075255|FG000|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11182435|NCT02075255|FG001|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
11182436|NCT02075255|FG002|Participant Flow|Placebo|Placebo administered subcutaneously
11182437|NCT02075255|OG000|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11182438|NCT02075255|OG001|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
11182439|NCT02075255|OG002|Outcome|Placebo|Placebo administered subcutaneously
11182440|NCT02075255|EG000|Reported Event|Benra 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11182441|NCT02075255|EG001|Reported Event|Benra 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
11182442|NCT02075255|EG002|Reported Event|Placebo|Placebo administered subcutaneously
11182443|NCT02075463|BG000|Baseline|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
11182444|NCT02075463|FG000|Participant Flow|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
11182445|NCT02075463|OG000|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
11182446|NCT02075463|OG000|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
11182447|NCT02075463|EG000|Reported Event|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
11182448|NCT02075476|BG000|Baseline|Hemiarthroplasty Global Fx(DePuy)|"in this technique the prosthesis is implanted in similar approach to shoulder anatomy~Hemiarthroplasty"
11182449|NCT02075476|BG001|Baseline|Reverse Arthroplasty Delta Xtent(DePuy)|"In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy~reverse arthroplasty"
11182450|NCT02075476|BG002|Baseline|Total|Total of all reporting groups
11182451|NCT02075476|FG000|Participant Flow|Hemiarthroplasty Global Fx(DePuy)|"in this technique the prosthesis is implanted in similar approach to shoulder anatomy~Hemiarthroplasty"
11182452|NCT02075476|FG001|Participant Flow|Reverse Arthroplasty Delta Xtent(DePuy)|"In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy~reverse arthroplasty"
11182453|NCT02075476|OG000|Outcome|Hemiarthroplasty Global Fx(DePuy)|"in this technique the prosthesis is implanted in similar approach to shoulder anatomy~Hemiarthroplasty"
11182454|NCT02075476|OG001|Outcome|Reverse Arthroplasty Delta Xtent(DePuy)|"In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy~reverse arthroplasty"
11182455|NCT02075476|EG000|Reported Event|Hemiarthroplasty Global Fx(DePuy)|"in this technique the prosthesis is implanted in similar approach to shoulder anatomy~Hemiarthroplasty"
11182456|NCT02075476|EG001|Reported Event|Reverse Arthroplasty Delta Xtent(DePuy)|"In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy~reverse arthroplasty"
11182457|NCT02075515|BG000|Baseline|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182458|NCT02075515|BG001|Baseline|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182459|NCT02075515|BG002|Baseline|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182460|NCT02075515|BG003|Baseline|Total|Total of all reporting groups
11182461|NCT02075515|FG000|Participant Flow|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
11182462|NCT02075515|FG001|Participant Flow|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182463|NCT02075515|FG002|Participant Flow|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182464|NCT02075515|OG000|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182465|NCT02075515|OG001|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182466|NCT02075515|OG002|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182467|NCT02075515|OG000|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
11182468|NCT02075515|EG000|Reported Event|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
11182469|NCT02075515|EG001|Reported Event|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182470|NCT02075515|EG002|Reported Event|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
11182471|NCT02075541|BG000|Baseline|10-AS01E Group|Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.
11182472|NCT02075541|BG001|Baseline|Control Group|Approximately 70 subjects who received 2 doses of placebo.
11182473|NCT02075541|BG002|Baseline|Total|Total of all reporting groups
11182474|NCT02075541|FG000|Participant Flow|10-AS01E Group|Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.
11182475|NCT02075541|FG001|Participant Flow|Control Group|Approximately 70 subjects who received 2 doses of placebo.
11182476|NCT02075541|OG000|Outcome|10-AS01E Group|Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.
11182477|NCT02075541|OG001|Outcome|Control Group|Approximately 70 subjects who received 2 doses of placebo.
11182478|NCT02075541|EG000|Reported Event|10-AS01E Group|Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.
11182479|NCT02075541|EG001|Reported Event|Control Group|Approximately 70 subjects who received 2 doses of placebo.
11182480|NCT02075554|BG000|Baseline|CALIBER|"1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion~CALIBER: Expandable interbody spacer"
11235223|NCT02441179|FG001|Participant Flow|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
11235224|NCT02441179|OG000|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
11235225|NCT02441179|OG001|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
11235226|NCT02441179|OG000|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
11235227|NCT02441179|EG000|Reported Event|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
11235228|NCT02441179|EG001|Reported Event|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
11235229|NCT02441218|BG000|Baseline|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
11235230|NCT02441218|BG001|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
11235231|NCT02441218|BG002|Baseline|Total|Total of all reporting groups
11235232|NCT02441218|FG000|Participant Flow|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
11235233|NCT02441218|FG001|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
11235234|NCT02441218|OG000|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
11235235|NCT02441218|OG001|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
11235236|NCT02441218|EG000|Reported Event|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
11235237|NCT02441218|EG001|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
11235238|NCT02441283|BG000|Baseline|HCV-infected Participants|Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study. The baseline data presented below are values at the time of the prior study start.
11182481|NCT02075554|FG000|Participant Flow|CALIBER|"1 or 2 levels of Degenerative Disc Disease between L2 and S1, treated with transforaminal interbody fusion~CALIBER: Expandable interbody spacer"
11182482|NCT02075554|OG000|Outcome|CALIBER|"1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion~CALIBER: Expandable interbody spacer"
11182483|NCT02075554|EG000|Reported Event|CALIBER|"1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion~CALIBER: Expandable interbody spacer"
11182484|NCT02075606|BG000|Baseline|Lanreotide Autogel|"Subjects received deep subcutaneous injections of lanreotide Autogel for 1 year to treat the symptoms of functioning midgut NETs.~A washout period was required for subjects receiving either subcutaneous octreotide (at least 2 weeks) or 1 injection of long-acting somatostatin analogue (at least 6 weeks) prior to treatment in the study.~Initially subjects began treatment with a dose of lanreotide Autogel 120 mg every 28 days for 3 months. Thereafter, the dose administered was determined on an individual subject basis by the treating clinician. Subjects could remain on the 120 mg dose, or be titrated to either 60 mg or 90 mg lanreotide Autogel, administered every 28 days according to their symptomatic response."
11182485|NCT02075606|FG000|Participant Flow|Lanreotide Autogel|"Subjects received deep subcutaneous injections of lanreotide Autogel for 1 year to treat the symptoms of functioning midgut NETs.~A washout period was required for subjects receiving either subcutaneous octreotide (at least 2 weeks) or 1 injection of long-acting somatostatin analogue (at least 6 weeks) prior to treatment in the study.~Initially subjects began treatment with a dose of lanreotide Autogel 120 milligrams (mg) every 28 days for 3 months. Thereafter, the dose administered was determined on an individual subject basis by the treating clinician. Subjects could remain on the 120 mg dose, or be titrated to either 60 mg or 90 mg lanreotide Autogel, administered every 28 days according to their symptomatic response."
11182486|NCT02075606|OG000|Outcome|CTC Presence at Baseline|"Subjects with a baseline presence of CTCs, determined by either or both baseline CTC blood samples having a CTC enumeration >0.~Baseline is defined as the 7 days preceding the first study treatment injection, or for subjects who required a washout period, these 7 days were during the washout period."
11182487|NCT02075606|OG001|Outcome|No CTC Presence at Baseline|"Subjects with no baseline presence of CTCs, determined by both baseline CTC blood samples having a CTC enumeration = 0.~Baseline is defined as the 7 days preceding the first study treatment injection, or for subjects who required a washout period, these 7 days were during the washout period."
11182488|NCT02075606|OG002|Outcome|Lanreotide Autogel|"Subjects received deep subcutaneous injections of lanreotide Autogel for 1 year to treat the symptoms of functioning midgut NETs.~A washout period was required for subjects receiving either subcutaneous octreotide (at least 2 weeks) or 1 injection of long-acting somatostatin analogue (at least 6 weeks) prior to treatment in the study.~Initially subjects began treatment with a dose of lanreotide Autogel 120 mg every 28 days for 3 months. Thereafter, the dose administered was determined on an individual subject basis by the treating clinician. Subjects could remain on the 120 mg dose, or be titrated to either 60 mg or 90 mg lanreotide Autogel, administered every 28 days according to their symptomatic response."
11182489|NCT02075606|OG002|Outcome|Missing CTC Status at Baseline|Subjects whose CTC status at baseline could not be evaluated as both CTC blood samples were missing. Baseline is defined as the 7 days preceding the first study treatment injection, or for subjects who required a washout period, these 7 days were during the washout period.
11182490|NCT02075606|OG003|Outcome|Lanreotide Autogel|"Subjects received deep subcutaneous injections of lanreotide Autogel for 1 year to treat the symptoms of functioning midgut NETs.~A washout period was required for subjects receiving either subcutaneous octreotide (at least 2 weeks) or 1 injection of long-acting somatostatin analogue (at least 6 weeks) prior to treatment in the study.~Initially subjects began treatment with a dose of lanreotide Autogel 120 mg every 28 days for 3 months. Thereafter, the dose administered was determined on an individual subject basis by the treating clinician. Subjects could remain on the 120 mg dose, or be titrated to either 60 mg or 90 mg lanreotide Autogel, administered every 28 days according to their symptomatic response."
11182491|NCT02075606|OG000|Outcome|Lanreotide Autogel|"Subjects received deep subcutaneous injections of lanreotide Autogel for 1 year to treat the symptoms of functioning midgut NETs.~A washout period was required for subjects receiving either subcutaneous octreotide (at least 2 weeks) or 1 injection of long-acting somatostatin analogue (at least 6 weeks) prior to treatment in the study.~Initially subjects began treatment with a dose of lanreotide Autogel 120 mg every 28 days for 3 months. Thereafter, the dose administered was determined on an individual subject basis by the treating clinician. Subjects could remain on the 120 mg dose, or be titrated to either 60 mg or 90 mg lanreotide Autogel, administered every 28 days according to their symptomatic response."
11182492|NCT02075606|EG000|Reported Event|Lanreotide Autogel|"Subjects received deep subcutaneous injections of lanreotide Autogel for 1 year to treat the symptoms of functioning midgut NETs.~A washout period was required for subjects receiving either subcutaneous octreotide (at least 2 weeks) or 1 injection of long-acting somatostatin analogue (at least 6 weeks) prior to treatment in the study.~Initially subjects began treatment with a dose of lanreotide Autogel 120 mg every 28 days for 3 months. Thereafter, the dose administered was determined on an individual subject basis by the treating clinician. Subjects could remain on the 120 mg dose, or be titrated to either 60 mg or 90 mg lanreotide Autogel, administered every 28 days according to their symptomatic response."
11182493|NCT02075632|BG000|Baseline|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
11182494|NCT02075632|BG001|Baseline|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used
11182495|NCT02075632|BG002|Baseline|Total|Total of all reporting groups
11182496|NCT02075632|FG000|Participant Flow|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
11182497|NCT02075632|FG001|Participant Flow|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
11182498|NCT02075632|OG000|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
11182499|NCT02075632|OG001|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
11182500|NCT02075632|EG000|Reported Event|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
11182501|NCT02075632|EG001|Reported Event|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
11182502|NCT02075658|BG000|Baseline|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
11182503|NCT02075658|BG001|Baseline|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
11182504|NCT02075658|BG002|Baseline|Total|Total of all reporting groups
11182505|NCT02075658|FG000|Participant Flow|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
11182506|NCT02075658|FG001|Participant Flow|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
11182507|NCT02075658|OG000|Outcome|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
11182508|NCT02075658|OG001|Outcome|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
11182509|NCT02075658|EG000|Reported Event|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
11182510|NCT02075658|EG001|Reported Event|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
11182511|NCT02076022|BG000|Baseline|Standard Fat Grafting|Standard fat graft: Aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas
11191383|NCT02132195|OG000|Outcome|Adrenocorticotropic Hormone (ACTH)|"Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2~The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose).~ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months."
11235239|NCT02441283|FG000|Participant Flow|HCV-infected Participants|Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study.
11235240|NCT02441283|OG000|Outcome|HCV-infected Participants|Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study.
11235241|NCT02441283|EG000|Reported Event|HCV-infected Participants-- FAS|Full Analysis Set (FAS): all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study. Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS.
11240764|NCT02481596|FG001|Participant Flow|REACH|"Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors).~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).~Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions."
11240765|NCT02481596|FG002|Participant Flow|Helpline & A1c Results|"Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.~Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions."
11240766|NCT02481596|OG000|Outcome|REACH + FAMS|REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
11240767|NCT02481596|OG001|Outcome|REACH|REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
11240768|NCT02481596|OG002|Outcome|Helpline & A1c Results|Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
11240769|NCT02481596|EG000|Reported Event|REACH + FAMS|"Participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months.~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions."
11240770|NCT02481596|EG001|Reported Event|REACH|"Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors).~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions."
11240771|NCT02481596|EG002|Reported Event|Helpline & A1c Results|"Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).~All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions."
11240772|NCT02481713|BG000|Baseline|MI Condition|"motivational interview condition~motivational interviewing: motivational interviewing"
11240773|NCT02481713|BG001|Baseline|CI Condition|"learning style interview condition~learning style interviews: interview and feedback about learning style"
11240774|NCT02481713|BG002|Baseline|Total|Total of all reporting groups
11240775|NCT02481713|FG000|Participant Flow|MI Condition|"motivational interview condition~motivational interviewing: motivational interviewing"
11240776|NCT02481713|FG001|Participant Flow|CI Condition|"learning style interview condition~learning style interviews: interview and feedback about learning style"
11240777|NCT02481713|OG000|Outcome|MI Condition|"motivational interview condition~motivational interviewing: motivational interviewing"
10847265|NCT00282438|OG000|Outcome|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
10847266|NCT00282438|OG001|Outcome|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
10847267|NCT00282438|EG000|Reported Event|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
10847268|NCT00282438|EG001|Reported Event|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
11240778|NCT02481713|OG001|Outcome|CI Condition|"learning style interview condition~learning style interviews: interview and feedback about learning style"
11240779|NCT02481713|EG000|Reported Event|MI Condition|"motivational interview condition~motivational interviewing: motivational interviewing"
10961801|NCT00863057|FG001|Participant Flow|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
11182512|NCT02076022|BG001|Baseline|Enhanced Fat Grafting|"Enhanced Fat Grafting: The stromal vascular fraction (SVF) cell suspension (device output) will be processed using the Tissue Genesis Cell Isolation System™~The Standard graft material and the stromal vascular fraction cells will be mixed and subsequently injected into the amputated stump at a concentration of 2.0 - 3.0 x 10 6 stromal vascular cells/ml of injected fat graft to each site. The volume of each injected fat graft will depend on the volume requirements for each injured extremity.~To manually combine the standard fat graft material and the SVF suspension (device output), each of the syringes will be connected via luer to luer lock. The contents of the lipoaspirate syringe are transferred to the SVF syringe and the cell suspension will be injected slowly back and forth between the two (2) syringes. The final 1 mL SVF-fat graft syringe is now considered cell-enriched and ready for injection into the subject."
11182513|NCT02076022|BG002|Baseline|Total|Total of all reporting groups
11182514|NCT02076022|FG000|Participant Flow|Standard Fat Grafting|Standard fat graft: Aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas
11182515|NCT02076022|FG001|Participant Flow|Enhanced Fat Grafting|"Enhanced Fat Grafting: The stromal vascular fraction (SVF) cell suspension (device output) will be processed using the Tissue Genesis Cell Isolation System™~The Standard graft material and the stromal vascular fraction cells will be mixed and subsequently injected into the amputated stump at a concentration of 2.0 - 3.0 x 10 6 stromal vascular cells/ml of injected fat graft to each site. The volume of each injected fat graft will depend on the volume requirements for each injured extremity.~To manually combine the standard fat graft material and the SVF suspension (device output), each of the syringes will be connected via luer to luer lock. The contents of the lipoaspirate syringe are transferred to the SVF syringe and the cell suspension will be injected slowly back and forth between the two (2) syringes. The final 1 mL SVF-fat graft syringe is now considered cell-enriched and ready for injection into the subject."
11182516|NCT02076022|OG000|Outcome|Standard Fat Grafting|Standard fat graft: Aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas
11182517|NCT02076022|OG001|Outcome|Enhanced Fat Grafting|"Enhanced Fat Grafting: The stromal vascular fraction (SVF) cell suspension (device output) will be processed using the Tissue Genesis Cell Isolation System™~The Standard graft material and the stromal vascular fraction cells will be mixed and subsequently injected into the amputated stump at a concentration of 2.0 - 3.0 x 10 6 stromal vascular cells/ml of injected fat graft to each site. The volume of each injected fat graft will depend on the volume requirements for each injured extremity.~To manually combine the standard fat graft material and the SVF suspension (device output), each of the syringes will be connected via luer to luer lock. The contents of the lipoaspirate syringe are transferred to the SVF syringe and the cell suspension will be injected slowly back and forth between the two (2) syringes. The final 1 mL SVF-fat graft syringe is now considered cell-enriched and ready for injection into the subject."
11182518|NCT02076022|EG000|Reported Event|Standard Fat Grafting|Standard fat graft: Aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas
11182519|NCT02076022|EG001|Reported Event|Enhanced Fat Grafting|"Enhanced Fat Grafting: The stromal vascular fraction (SVF) cell suspension (device output) will be processed using the Tissue Genesis Cell Isolation System™~The Standard graft material and the stromal vascular fraction cells will be mixed and subsequently injected into the amputated stump at a concentration of 2.0 - 3.0 x 10 6 stromal vascular cells/ml of injected fat graft to each site. The volume of each injected fat graft will depend on the volume requirements for each injured extremity.~To manually combine the standard fat graft material and the SVF suspension (device output), each of the syringes will be connected via luer to luer lock. The contents of the lipoaspirate syringe are transferred to the SVF syringe and the cell suspension will be injected slowly back and forth between the two (2) syringes. The final 1 mL SVF-fat graft syringe is now considered cell-enriched and ready for injection into the subject."
11182520|NCT02076100|BG000|Baseline|Ruzasvir 10 mg - GT3|GT3 participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182521|NCT02076100|BG001|Baseline|Ruzasvir 30 mg - GT3|GT3 participants were administered 30 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182522|NCT02076100|BG002|Baseline|Ruzasvir 60 mg - GT3|GT3 participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182523|NCT02076100|BG003|Baseline|Ruzasvir 120 mg - GT3|GT3 participants were administered 120 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182524|NCT02076100|BG004|Baseline|Ruzasvir 10 mg - GT2b|GT2b participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182525|NCT02076100|BG005|Baseline|Ruzasvir 60 mg - GT2b|GT2b participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182526|NCT02076100|BG006|Baseline|Ruzasvir 60 mg - GT1a|GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days. One participant was later determined to be GT1b.
11182527|NCT02076100|BG007|Baseline|Total|Total of all reporting groups
11182528|NCT02076100|FG000|Participant Flow|Ruzasvir 10 mg - GT3|GT3 participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182529|NCT02076100|FG001|Participant Flow|Ruzasvir 30 mg - GT3|GT3 participants were administered 30 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182530|NCT02076100|FG002|Participant Flow|Ruzasvir 60 mg - GT3|GT3 participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182531|NCT02076100|FG003|Participant Flow|Ruzasvir 120 mg - GT3|GT3 participants were administered 120 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182532|NCT02076100|FG004|Participant Flow|Ruzasvir 10 mg - GT2b|GT2b participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182533|NCT02076100|FG005|Participant Flow|Ruzasvir 60 mg - GT2b|GT2b participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182534|NCT02076100|FG006|Participant Flow|Ruzasvir 60 mg - GT1a|GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days. One participant was later determined to be GT1b.
11182535|NCT02076100|OG000|Outcome|Ruzasvir 10 mg - GT3|GT3 participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182536|NCT02076100|OG001|Outcome|Ruzasvir 30 mg - GT3|GT3 participants were administered 30 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182537|NCT02076100|OG002|Outcome|Ruzasvir 60 mg - GT3|GT3 participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182538|NCT02076100|OG003|Outcome|Ruzasvir 120 mg - GT3|GT3 participants were administered 120 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182539|NCT02076100|OG004|Outcome|Ruzasvir 10 mg - GT2b|GT2b participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182540|NCT02076100|OG005|Outcome|Ruzasvir 60 mg - GT2b|GT2b participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182541|NCT02076100|OG006|Outcome|Ruzasvir 60 mg - GT1a|GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182542|NCT02076100|OG007|Outcome|Ruzasvir 60 mg - GT1b|A GT1b participant was administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182543|NCT02076100|OG002|Outcome|Ruzasvir 60 mg - GT3|Participants with GT3 were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182544|NCT02076100|OG006|Outcome|Ruzasvir 60 mg - GT1a|GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days. One participant was later determined to be GT1b.
11182545|NCT02076100|OG000|Outcome|Ruzasvir 10 mg - GT3|Participants with GT3 were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182546|NCT02076100|EG000|Reported Event|Ruzasvir 10 mg - GT3|GT3 participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182547|NCT02076100|EG001|Reported Event|Ruzasvir 30 mg - GT3|GT3 participants were administered 30 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182548|NCT02076100|EG002|Reported Event|Ruzasvir 60 mg - GT3|GT3 participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182549|NCT02076100|EG003|Reported Event|Ruzasvir 120 mg - GT3|GT3 participants were administered 120 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182550|NCT02076100|EG004|Reported Event|Ruzasvir 10 mg - GT2b|GT2b participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182551|NCT02076100|EG005|Reported Event|Ruzasvir 60 mg - GT2b|GT2b participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
11182552|NCT02076100|EG006|Reported Event|Ruzasvir 60 mg - GT1a|GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days. One participant was later determined to be GT1b.
11182553|NCT02076113|BG000|Baseline|Ventral|"Ventral Decompression with Fusion~Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications."
11182554|NCT02076113|BG001|Baseline|Dorsal|"Dorsal Decompression with Fusion or Dorsal Laminoplasty~Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.~Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter."
11182555|NCT02076113|BG002|Baseline|Total|Total of all reporting groups
11182556|NCT02076113|FG000|Participant Flow|Ventral|"Ventral Decompression with Fusion~Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications."
11191384|NCT02132195|OG001|Outcome|No Treatment|Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. There is an option for the patient to elect to be placed in the active treatment arm of the trial (rescue therapy).
11240780|NCT02481713|EG001|Reported Event|CI Condition|"learning style interview condition~learning style interviews: interview and feedback about learning style"
11182557|NCT02076113|FG001|Participant Flow|Dorsal|"Dorsal Decompression with Fusion or Dorsal Laminoplasty~Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.~Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter."
11182558|NCT02076113|OG000|Outcome|Ventral|"Ventral Decompression with Fusion~Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications."
11182559|NCT02076113|OG001|Outcome|Dorsal|"Dorsal Decompression with Fusion or Dorsal Laminoplasty~Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.~Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter."
11182560|NCT02076113|OG001|Outcome|Dorsal Decompression With Fusion|Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
11182561|NCT02076113|OG002|Outcome|Dorsal Laminoplasty|Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
11182562|NCT02076113|EG000|Reported Event|Ventral|"Ventral Decompression with Fusion~Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications."
11182563|NCT02076113|EG001|Reported Event|Dorsal Decompression With Fusion|Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
11182564|NCT02076113|EG002|Reported Event|Dorsal Laminoplasty|Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
11182565|NCT02076152|BG000|Baseline|FMISO PET & MRI Group 1|"Bevacizumab:~Bevacizumab will be administered at a dose of 10 mg/kg i.v. every 14 days per standard of care and the drug label. A cycle is defined as 28 days (1 month).~-FMISO PET Scan~FMISO will be intravenously injected at a dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. The IV will remain in place for injection of the gadolinium for the MRI scan. There will be one injection of FMISO in the PET protocol. Approximately 90 minutes after the injection, the PET scan will begin.~The PET scan will be approximately 60-75 minutes.~- MRI~Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs.~FMISO PET~MRI: MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The Autoalign package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs.~Bevacizumab: A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician."
11182566|NCT02076152|BG001|Baseline|FMISO PET & MRI Group 2|"Bevacizumab + CCNU:~Bevacizumab administered at dose of 10 mg/kg IV every 14 days per standard of care and drug label. Cycle defined as 28 days (1 month). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.~CCNU administered at dose of 110 mg/m2 every 42 days per standard of care and drug label. Cycle defined as 28 days (1 month). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.~-FMISO PET Scan~FMISO intravenously injected at dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. IV will remain in place for injection of gadolinium for MRI scan. One injection of FMISO in PET protocol. Approximately 90 min after injection, PET scan will begin.~PET scan will be approximately 60-75 minutes~- MRI~Each MRI will last 60-75 minutes vs 45 minutes for standard brain MRIs.~FMISO PET~MRI: MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The Autoalign package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes vs 45 minutes for standard brain MRIs."
11182567|NCT02076152|BG002|Baseline|Total|Total of all reporting groups
11191385|NCT02132195|OG002|Outcome|Rescue Therapy|"Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.~Other Names:~Acthar Adrenocorticotropic hormon"
11235242|NCT02441309|BG000|Baseline|A. Mifamurtide Only|"Patients receive Mifamurtide only.~Treatment Weeks 1-6 (post 1st biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 13-36:~Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide"
11235243|NCT02441309|BG001|Baseline|B. Ifosfamide (Followed by Mifamurtide)|"Patients receive Ifosfamide alone initially, followed by ifosfamide plus mifamurtide, then mifamurtide alone.~Treatment Weeks 1-6: Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days as per local practice. Repeated every 21 days for 2 cycles (3 weeks=1 cycle).~Treatment Weeks 7-12 (post 2nd biopsy/resection): Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle). Ifosfamide administered as per local practice, including concurrent dosing with mesna. Plus mifamurtide 2mg/m2, IV infusion, twice/week. Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 13-18: Mifamurtide 2mg/m2, IV infusion, twice/week. Treatment Weeks 19-42: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235244|NCT02441309|BG002|Baseline|C. Ifosfamide + Mifamurtide|"Patients receive mifamurtide combined with ifosfamide initially.~Treatment Weeks 1-6:~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle).~Plus Mifamurtide 2 mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks.~Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion infused over 4-5 days once every 21 days for two cycles (3 weeks = 1 cycle).~Plus Mifamurtide 2mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks. Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 13-36: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235245|NCT02441309|BG003|Baseline|Total|Total of all reporting groups
11235246|NCT02441309|FG000|Participant Flow|A. Mifamurtide Only|"Patients receive Mifamurtide only.~Treatment Weeks 1-6 (post 1st biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 13-36:~Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide"
11235247|NCT02441309|FG001|Participant Flow|B. Ifosfamide (Followed by Mifamurtide)|"Patients receive Ifosfamide alone initially, followed by ifosfamide plus mifamurtide, then mifamurtide alone.~Treatment Weeks 1-6: Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days as per local practice. Repeated every 21 days for 2 cycles (3 weeks=1 cycle).~Treatment Weeks 7-12 (post 2nd biopsy/resection): Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle). Ifosfamide administered as per local practice, including concurrent dosing with mesna. Plus mifamurtide 2mg/m2, IV infusion, twice/week. Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 13-18: Mifamurtide 2mg/m2, IV infusion, twice/week. Treatment Weeks 19-42: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235248|NCT02441309|FG002|Participant Flow|C. Ifosfamide + Mifamurtide|"Patients receive mifamurtide combined with ifosfamide initially.~Treatment Weeks 1-6:~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle).~Plus Mifamurtide 2 mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks.~Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion infused over 4-5 days once every 21 days for two cycles (3 weeks = 1 cycle).~Plus Mifamurtide 2mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks. Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 13-36: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235249|NCT02441309|OG000|Outcome|A. Mifamurtide Only|"Patients receive Mifamurtide only.~Treatment Weeks 1-6 (post 1st biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 13-36:~Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide"
11235250|NCT02441309|OG001|Outcome|B. Ifosfamide (Followed by Mifamurtide)|"Patients receive Ifosfamide alone initially, followed by ifosfamide plus mifamurtide, then mifamurtide alone.~Treatment Weeks 1-6: Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days as per local practice. Repeated every 21 days for 2 cycles (3 weeks=1 cycle).~Treatment Weeks 7-12 (post 2nd biopsy/resection): Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle). Ifosfamide administered as per local practice, including concurrent dosing with mesna. Plus mifamurtide 2mg/m2, IV infusion, twice/week. Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 13-18: Mifamurtide 2mg/m2, IV infusion, twice/week. Treatment Weeks 19-42: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11341792|NCT03688542|EG000|Reported Event|Intervention|"Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy.~Quality Circle Deprescribing Module: The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus.."
11235251|NCT02441309|OG002|Outcome|C. Ifosfamide + Mifamurtide|"Patients receive mifamurtide combined with ifosfamide initially.~Treatment Weeks 1-6:~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle).~Plus Mifamurtide 2 mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks.~Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion infused over 4-5 days once every 21 days for two cycles (3 weeks = 1 cycle).~Plus Mifamurtide 2mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks. Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 13-36: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235252|NCT02441309|OG000|Outcome|A. Mifamurtide Only|"Treatment Weeks 1-6 (post 1st biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 13-36:~Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide"
11235253|NCT02441309|OG001|Outcome|B. Ifosfamide (Followed by Mifamurtide)|"Treatment Weeks 1-6: Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days as per local practice. Repeated every 21 days for 2 cycles (3 weeks=1 cycle).~Treatment Weeks 7-12 (post 2nd biopsy/resection): Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle). Ifosfamide administered as per local practice, including concurrent dosing with mesna. Plus mifamurtide 2mg/m2, IV infusion, twice/week. Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6.~Treatment Weeks 13-18: Mifamurtide 2mg/m2, IV infusion, twice/week. Treatment Weeks 19-42: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235254|NCT02441309|OG002|Outcome|C. Ifosfamide + Mifamurtide|"Treatment Weeks 1-6:~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle).~Plus Mifamurtide 2mg/m2, IV infusion, twice per week, each given at least 3 days apart, for 6 weeks.~Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion over 4-5 days once every 21 days for two cycles (3 weeks = 1 cycle).~Plus Mifamurtide 2mg/m2, IV infusion, twice per week, given at least 3 days apart, for 6 weeks. Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6.~Treatment Weeks 13-36: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235255|NCT02441309|EG000|Reported Event|A. Mifamurtide Only|"Patients receive Mifamurtide only.~Treatment Weeks 1-6 (post 1st biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.~Treatment Weeks 13-36:~Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide"
11235256|NCT02441309|EG001|Reported Event|B. Ifosfamide (Followed by Mifamurtide)|"Patients receive Ifosfamide alone initially, followed by ifosfamide plus mifamurtide, then mifamurtide alone.~Treatment Weeks 1-6: Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days as per local practice. Repeated every 21 days for 2 cycles (3 weeks=1 cycle).~Treatment Weeks 7-12 (post 2nd biopsy/resection): Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle). Ifosfamide administered as per local practice, including concurrent dosing with mesna. Plus mifamurtide 2mg/m2, IV infusion, twice/week. Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 13-18: Mifamurtide 2mg/m2, IV infusion, twice/week. Treatment Weeks 19-42: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235257|NCT02441309|EG002|Reported Event|C. Ifosfamide + Mifamurtide|"Patients receive mifamurtide combined with ifosfamide initially.~Treatment Weeks 1-6:~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle).~Plus Mifamurtide 2 mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks.~Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 7-12 (post 2nd biopsy/resection):~Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion infused over 4-5 days once every 21 days for two cycles (3 weeks = 1 cycle).~Plus Mifamurtide 2mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks. Ifosfamide infusion must be started 24 hours prior to mifamurtide. Mifamurtide should be given on day 2 and either day 5 or day 6.~Treatment Weeks 13-36: Mifamurtide 2mg/m2, IV infusion, once/week.~Mifamurtide~Ifosfamide"
11235258|NCT02441517|BG000|Baseline|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
11235259|NCT02441517|FG000|Participant Flow|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
11235260|NCT02441517|OG000|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
11235261|NCT02441517|EG000|Reported Event|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
11235262|NCT02441946|BG000|Baseline|Abemaciclib + Anastrozole|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235263|NCT02441946|BG001|Baseline|Abemaciclib|"Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235264|NCT02441946|BG002|Baseline|Anastrozole|"Participants received 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235265|NCT02441946|BG003|Baseline|Total|Total of all reporting groups
11341793|NCT03688542|EG001|Reported Event|Control|Nursing Homes allocated to the Control arm will not enact the intervention.
11182568|NCT02076152|FG000|Participant Flow|FMISO PET & MRI Group 1|"Bevacizumab:~Bevacizumab will be administered at a dose of 10 mg/kg i.v. every 14 days per standard of care and the drug label. A cycle is defined as 28 days (1 month).~-FMISO PET Scan~FMISO will be intravenously injected at a dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. The IV will remain in place for injection of the gadolinium for the MRI scan. There will be one injection of FMISO in the PET protocol. Approximately 90 minutes after the injection, the PET scan will begin.~The PET scan will be approximately 60-75 minutes.~-MRI~Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs.~FMISO PET~MRI: MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The Autoalign package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs.~Bevacizumab: A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician."
11182569|NCT02076152|FG001|Participant Flow|FMISO PET & MRI Group 2|"Bevacizumab + CCNU:~Bevacizumab administered at dose of 10 mg/kg IV every 14 days per standard of care and drug label. Cycle defined as 28 days (1 month). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.~CCNU administered at dose of 110 mg/m2 every 42 days per standard of care and drug label. Cycle defined as 28 days (1 month). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.~-FMISO PET Scan~FMISO intravenously injected at dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. IV will remain in place for injection of gadolinium for MRI scan. One injection of FMISO in PET protocol. Approximately 90 min after injection, PET scan will begin.~PET scan will be approximately 60-75 minutes~- MRI~Each MRI will last 60-75 minutes vs 45 minutes for standard brain MRIs.~FMISO PET~MRI: MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The Autoalign package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes vs 45 minutes for standard brain MRIs."
11182570|NCT02076152|OG000|Outcome|FMISO PET & MRI (Combined Groups)|"Bevacizumab + CCNU:~Bevacizumab administered at dose of 10 mg/kg IV every 14 days per standard of care and drug label. Cycle defined as 28 days (1 month). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.~CCNU administered at dose of 110 mg/m2 every 42 days per standard of care and drug label. Cycle defined as 28 days (1 month). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.~-FMISO PET Scan~FMISO intravenously injected at dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. IV will remain in place for injection of gadolinium for MRI scan. One injection of FMISO in PET protocol. Approximately 90 min after injection, PET scan will begin.~PET scan will be approximately 60-75 minutes~- MRI~Each MRI will last 60-75 minutes vs 45 minutes for standard brain MRIs.~FMISO PET~MRI: MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The Autoalign package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes vs 45 minutes for standard brain MRIs."
11182571|NCT02076152|EG000|Reported Event|FMISO PET & MRI Group 1|"Bevacizumab:~Bevacizumab will be administered at a dose of 10 mg/kg i.v. every 14 days per standard of care and the drug label. A cycle is defined as 28 days (1 month).~-FMISO PET Scan~FMISO will be intravenously injected at a dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. The IV will remain in place for injection of the gadolinium for the MRI scan. There will be one injection of FMISO in the PET protocol. Approximately 90 minutes after the injection, the PET scan will begin.~The PET scan will be approximately 60-75 minutes.~-MRI~Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs.~FMISO PET~MRI: MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The Autoalign package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs.~Bevacizumab: A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician."
11191386|NCT02132195|EG000|Reported Event|Adrenocorticotropic Hormone (ACTH)|"Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2~The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose).~ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months."
11191387|NCT02132195|EG001|Reported Event|No Treatment|Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study.
11191388|NCT02132195|EG002|Reported Event|Rescue Therapy|"Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.~Other Names:~Acthar Adrenocorticotropic hormon"
11191389|NCT02132247|BG000|Baseline|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
11182572|NCT02076152|EG001|Reported Event|FMISO PET & MRI Group 2|"Bevacizumab + CCNU:~Bevacizumab administered at dose of 10 mg/kg IV every 14 days per standard of care and drug label. Cycle defined as 28 days (1 month). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.~CCNU administered at dose of 110 mg/m2 every 42 days per standard of care and drug label. Cycle defined as 28 days (1 month). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.~-FMISO PET Scan~FMISO intravenously injected at dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. IV will remain in place for injection of gadolinium for MRI scan. One injection of FMISO in PET protocol. Approximately 90 min after injection, PET scan will begin.~PET scan will be approximately 60-75 minutes~- MRI~Each MRI will last 60-75 minutes vs 45 minutes for standard brain MRIs.~FMISO PET~MRI: MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The Autoalign package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes vs 45 minutes for standard brain MRIs."
11182573|NCT02076165|BG000|Baseline|ABC-I|"Participants will participate in 5 individual sessions with a trained instructor.~Behavioral treatment for insomnia-Group I: Participants will attend 5 individual sessions with a trained instructor."
11182574|NCT02076165|BG001|Baseline|CBT-I|"Participants will participate in 5 individual sessions with a trained instructor.~Behavioral treatment for insomnia-Group II: Participants will attend in 5 individual sessions with a trained instructor."
11182575|NCT02076165|BG002|Baseline|Total|Total of all reporting groups
11182576|NCT02076165|FG000|Participant Flow|ABC-I|"Experimental: ABC-I Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the new treatment being studied."
11182577|NCT02076165|FG001|Participant Flow|CBT-I|"Active Comparator: CBT-I Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the standard care treatment."
11182578|NCT02076165|OG000|Outcome|ABC-I|"Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the new treatment being studied."
11182579|NCT02076165|OG001|Outcome|CBT-I|"Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the standard care treatment."
11182580|NCT02076165|EG000|Reported Event|ABC-I|"Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the new treatment being studied."
11182581|NCT02076165|EG001|Reported Event|CBT-I|"Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the standard care treatment."
11182582|NCT02076243|BG000|Baseline|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
11182583|NCT02076243|FG000|Participant Flow|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
11182584|NCT02076243|OG000|Outcome|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
11182585|NCT02076243|EG000|Reported Event|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
11182586|NCT02076321|BG000|Baseline|Acetaminophen|"control group~Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day)."
11182587|NCT02076321|BG001|Baseline|NSAID (Ibuprofen)|"Study group~Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg."
11182588|NCT02076321|BG002|Baseline|Total|Total of all reporting groups
11182589|NCT02076321|FG000|Participant Flow|Acetaminophen|"control group~Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day)."
11182590|NCT02076321|FG001|Participant Flow|NSAID (Ibuprofen)|"Study group~Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg."
11182591|NCT02076321|OG000|Outcome|Acetaminophen|"control group~Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day)."
11182592|NCT02076321|OG001|Outcome|NSAID (Ibuprofen)|"Study group~Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg."
11182593|NCT02076321|EG000|Reported Event|Acetaminophen|"control group~Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day)."
11182594|NCT02076321|EG001|Reported Event|NSAID (Ibuprofen)|"Study group~Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg."
11235266|NCT02441946|FG000|Participant Flow|Abemaciclib + Anastrozole|"Participants were given 150 milligram (mg) of abemaciclib orally every 12 hours (Q12H) plus 1 mg of anastrozole orally once daily (QD) for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235267|NCT02441946|FG001|Participant Flow|Abemaciclib|"Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235268|NCT02441946|FG002|Participant Flow|Anastrozole|"Participants received 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235269|NCT02441946|OG000|Outcome|Abemaciclib + Anastrozole|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235270|NCT02441946|OG001|Outcome|Abemaciclib|"Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235271|NCT02441946|OG002|Outcome|Anastrozole|"Participants received 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235272|NCT02441946|OG001|Outcome|Abemaciclib|"Cycle 1 participants received 150 mg of abemaciclib orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks (post cycle 1).~Total treatment duration was 16 weeks."
11235273|NCT02441946|OG002|Outcome|Anastrozole|"Cycle 1 participants received 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks (post cycle 1).~Abemaciclib PK samples were collected during cycles 3-5.~Total treatment duration was 16 weeks.~The data presented in this cohort is for abemaciclib PK following cycles 3-5."
11235274|NCT02441946|EG000|Reported Event|Abemaciclib + Anastrozole Cycle 1|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235275|NCT02441946|EG001|Reported Event|Abemaciclib Cycle 1|"Participants received 150 mg of abemaciclib orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235276|NCT02441946|EG002|Reported Event|Anastrozole Cycle 1|"Participants received 1 mg of anastrozole orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.~Total treatment duration was 16 weeks.~."
11235277|NCT02441946|EG003|Reported Event|Abemaciclib + Anastrozole Cycle 2 and Beyond|"Combination Therapy: All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
11235278|NCT02442206|BG000|Baseline|Treatment Sequence 1|QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43
11235279|NCT02442206|BG001|Baseline|Treatment Sequence 2|Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43
11235280|NCT02442206|BG002|Baseline|Total|Total of all reporting groups
11235281|NCT02442206|FG000|Participant Flow|Treatment Sequence 1|QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43
11235282|NCT02442206|FG001|Participant Flow|Treatment Sequence 2|Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43
11235283|NCT02442206|OG000|Outcome|QVA149|QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43
11235284|NCT02442206|OG001|Outcome|Placebo|Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43
11235285|NCT02442206|EG000|Reported Event|QVA149 (110/50)|QVA149 (110/50)
11235286|NCT02442206|EG001|Reported Event|Placebo|Placebo
11235287|NCT02442206|EG002|Reported Event|All Patients|All Patients
11235288|NCT02442271|BG000|Baseline|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
11235289|NCT02442271|FG000|Participant Flow|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
11235290|NCT02442271|OG000|Outcome|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
11235291|NCT02442271|OG000|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
11235292|NCT02442271|OG001|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
11235293|NCT02442271|OG000|Outcome|Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection.
11235294|NCT02442271|OG001|Outcome|Pegylated Interferon (PegIFN)/RBV Null Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course
11235295|NCT02442271|OG002|Outcome|Pegylated Interferon (PegIFN)//RBV Partial Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
11235296|NCT02442271|OG003|Outcome|Pegylated Interferon (PegIFN)/RBV Non-Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
11182595|NCT02076334|BG000|Baseline|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
11182596|NCT02076334|BG001|Baseline|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
11182597|NCT02076334|BG002|Baseline|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
11182598|NCT02076334|BG003|Baseline|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
11182599|NCT02076334|BG004|Baseline|Total|Total of all reporting groups
11182600|NCT02076334|FG000|Participant Flow|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
11182601|NCT02076334|FG001|Participant Flow|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
11182602|NCT02076334|FG002|Participant Flow|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
11182603|NCT02076334|FG003|Participant Flow|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
11182604|NCT02076334|OG000|Outcome|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
11182605|NCT02076334|OG001|Outcome|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
11182606|NCT02076334|OG002|Outcome|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
11182607|NCT02076334|OG003|Outcome|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
11182608|NCT02076334|EG000|Reported Event|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
11182609|NCT02076334|EG001|Reported Event|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
11182610|NCT02076334|EG002|Reported Event|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
11182611|NCT02076334|EG003|Reported Event|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
11182612|NCT02076399|BG000|Baseline|Fostamatinib Recipient|Fostamatinib (100 mg PO bid or 150 mg PO bid)
11182613|NCT02076399|BG001|Baseline|Placebo Recipient|Placebo
11182614|NCT02076399|BG002|Baseline|Total|Total of all reporting groups
11182615|NCT02076399|FG000|Participant Flow|Fostamatinib Recipient|Fostamatinib (100 mg PO bid or 150 mg PO bid)
11182616|NCT02076399|FG001|Participant Flow|Placebo Recipient|Placebo
11182617|NCT02076399|OG000|Outcome|Fostamatinib Recipient|Fostamatinib (100 mg PO bid or 150 mg PO bid)
11182618|NCT02076399|OG001|Outcome|Placebo Recipient|Placebo
11182619|NCT02076399|EG000|Reported Event|Fostamatinib Recipient|Fostamatinib (100 mg PO bid or 150 mg PO bid)
11182620|NCT02076399|EG001|Reported Event|Placebo Recipient|Placebo
11182621|NCT02076412|BG000|Baseline|Fostamatinib Recipient|Fostamatinib (100 mg PO bid or 150 mg PO bid)
11182622|NCT02076412|BG001|Baseline|Placebo Recipient|Placebo
11182623|NCT02076412|BG002|Baseline|Total|Total of all reporting groups
11182624|NCT02076412|FG000|Participant Flow|Fostamatinib Recipient|Fostamatinib (100 mg PO bid or 150 mg PO bid)
11182625|NCT02076412|FG001|Participant Flow|Placebo Recipient|Placebo
11182626|NCT02076412|OG000|Outcome|Fostamatinib Recipient|Fostamatinib (100 mg PO bid or 150 mg PO bid)
11182627|NCT02076412|OG001|Outcome|Placebo Recipient|Placebo
11182628|NCT02076412|EG000|Reported Event|Fostamatinib Recipient|Fostamatinib (100 mg PO bid or 150 mg PO bid)
11182629|NCT02076412|EG001|Reported Event|Placebo Recipient|Placebo
11182630|NCT02076425|BG000|Baseline|PCIT-ED|"Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.~PCIT-ED"
11182631|NCT02076425|BG001|Baseline|Wait List|No intervention while subjects wait for PCIT-ED in the second phase of the study.
11182632|NCT02076425|BG002|Baseline|Total|Total of all reporting groups
11182633|NCT02076425|FG000|Participant Flow|PCIT-ED|"Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.~PCIT-ED"
11182634|NCT02076425|FG001|Participant Flow|Wait List|No intervention while subjects wait for PCIT-ED in the second phase of the study.
11182635|NCT02076425|OG000|Outcome|PCIT-ED|"Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.~PCIT-ED"
11182636|NCT02076425|OG001|Outcome|Wait List|No intervention while subjects wait for PCIT-ED in the second phase of the study.
11182637|NCT02076425|EG000|Reported Event|PCIT-ED|"Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.~PCIT-ED"
11182638|NCT02076425|EG001|Reported Event|Wait List|No intervention while subjects wait for PCIT-ED in the second phase of the study.
11182639|NCT02076776|BG000|Baseline|Repetitive Task Practice (RTP)|"This group focuses on RTP.~Repetitive Task Practice (RTP): This group will preform arm and hand therapy."
11182640|NCT02076776|BG001|Baseline|Voluntary Cycling + RTP|"This group involves one biking session and one RTP session three times per week for eight weeks.~Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike."
11182641|NCT02076776|BG002|Baseline|Assisted Cycling + RTP|"This group involves one biking session and one RTP session three times per week for eight weeks.~Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike."
11182642|NCT02076776|BG003|Baseline|Total|Total of all reporting groups
11182643|NCT02076776|FG000|Participant Flow|Repetitive Task Practice (RTP)|"This group focuses on RTP.~Repetitive Task Practice (RTP): This group will preform arm and hand therapy."
11182644|NCT02076776|FG001|Participant Flow|Voluntary Cycling + RTP|"This group involves one biking session and one RTP session three times per week for eight weeks.~Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike."
11182645|NCT02076776|FG002|Participant Flow|Assisted Cycling + RTP|"This group involves one biking session and one RTP session three times per week for eight weeks.~Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike."
11182646|NCT02076776|OG000|Outcome|Repetitive Task Practice (RTP)|"This group focuses on RTP.~Repetitive Task Practice (RTP): This group will preform arm and hand therapy."
11182647|NCT02076776|OG001|Outcome|Voluntary Cycling + RTP|"This group involves one biking session and one RTP session three times per week for eight weeks.~Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike."
11182648|NCT02076776|OG002|Outcome|Assisted Cycling + RTP|"This group involves one biking session and one RTP session three times per week for eight weeks.~Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike."
11182649|NCT02076776|EG000|Reported Event|Repetitive Task Practice (RTP)|"This group focuses on RTP.~Repetitive Task Practice (RTP): This group will preform arm and hand therapy."
11182650|NCT02076776|EG001|Reported Event|Voluntary Cycling + RTP|"This group involves one biking session and one RTP session three times per week for eight weeks.~Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike."
11182651|NCT02076776|EG002|Reported Event|Assisted Cycling + RTP|"This group involves one biking session and one RTP session three times per week for eight weeks.~Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike."
11182652|NCT02076919|BG000|Baseline|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
11182653|NCT02076919|BG001|Baseline|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
11182654|NCT02076919|BG002|Baseline|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
11182655|NCT02076919|BG003|Baseline|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
11182656|NCT02076919|BG004|Baseline|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
11182657|NCT02076919|BG005|Baseline|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182658|NCT02076919|BG006|Baseline|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182659|NCT02076919|BG007|Baseline|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182660|NCT02076919|BG008|Baseline|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182661|NCT02076919|BG009|Baseline|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
11182662|NCT02076919|BG010|Baseline|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
11182663|NCT02076919|BG011|Baseline|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
11182664|NCT02076919|BG012|Baseline|Total|Total of all reporting groups
11182665|NCT02076919|FG000|Participant Flow|LHA510, Part 1|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1
11182666|NCT02076919|FG001|Participant Flow|Vehicle, Part 1|Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1
11182667|NCT02076919|FG002|Participant Flow|LHA510, Part 2|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2
11182668|NCT02076919|FG003|Participant Flow|Vehicle, Part 2|Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
11182669|NCT02076919|OG000|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
11182670|NCT02076919|OG001|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
11182671|NCT02076919|OG002|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
11182672|NCT02076919|OG003|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
11182673|NCT02076919|OG004|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
11182674|NCT02076919|OG000|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182675|NCT02076919|OG001|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182676|NCT02076919|OG002|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182677|NCT02076919|OG003|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182678|NCT02076919|OG004|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
11182679|NCT02076919|OG005|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
11182680|NCT02076919|OG006|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
11182681|NCT02076919|OG006|Outcome|Vehicle, Part 2|One drop instilled in the study eye once, twice, or three times daily for 7 days
11182682|NCT02076919|EG000|Reported Event|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
11182683|NCT02076919|EG001|Reported Event|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
11182684|NCT02076919|EG002|Reported Event|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
11182685|NCT02076919|EG003|Reported Event|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
11182686|NCT02076919|EG004|Reported Event|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
11182687|NCT02076919|EG005|Reported Event|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182688|NCT02076919|EG006|Reported Event|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182689|NCT02076919|EG007|Reported Event|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182690|NCT02076919|EG008|Reported Event|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
11182691|NCT02076919|EG009|Reported Event|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
11182692|NCT02076919|EG010|Reported Event|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
11182693|NCT02076919|EG011|Reported Event|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
11182694|NCT02076997|BG000|Baseline|Individualized High Dose Methotrexate|"Individualized high dose methotrexate given as a 24-hour infusion.~Methotrexate: Patients will receive 5g/m^2 high dose methotrexate as a 24 hour infusion.~The methotrexate level in the blood will be checked at two times during the 24-infusion. The dose will be reduced based on the level in the blood."
11182695|NCT02076997|FG000|Participant Flow|Individualized High Dose Methotrexate|"Individualized high dose methotrexate given as a 24-hour infusion.~Methotrexate: Patients will receive 5g/m^2 high dose methotrexate as a 24 hour infusion.~The methotrexate level in the blood will be checked at two times during the 24-infusion. The dose will be reduced based on the level in the blood."
11182696|NCT02076997|OG000|Outcome|Individualized High Dose Methotrexate|"Individualized high dose methotrexate given as a 24-hour infusion.~Methotrexate: Patients will receive 5g/m^2 high dose methotrexate as a 24 hour infusion.~The methotrexate level in the blood will be checked at two times during the 24-infusion. The dose will be reduced based on the level in the blood."
11182697|NCT02076997|EG000|Reported Event|Individualized High Dose Methotrexate|"Individualized high dose methotrexate given as a 24-hour infusion.~Methotrexate: Patients will receive 5g/m^2 high dose methotrexate as a 24 hour infusion.~The methotrexate level in the blood will be checked at two times during the 24-infusion. The dose will be reduced based on the level in the blood."
11182698|NCT02077140|BG000|Baseline|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
11182699|NCT02077140|BG001|Baseline|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
11182700|NCT02077140|BG002|Baseline|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
11182701|NCT02077140|BG003|Baseline|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
11182702|NCT02077140|BG004|Baseline|Control (In Cohort 1 to 4)|Control subjects in Cohort 1 to 4 received standard of care for pain control.
11182703|NCT02077140|BG005|Baseline|Total|Total of all reporting groups
11182704|NCT02077140|FG000|Participant Flow|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
11182705|NCT02077140|FG001|Participant Flow|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
11182706|NCT02077140|FG002|Participant Flow|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
11182707|NCT02077140|FG003|Participant Flow|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
11182708|NCT02077140|FG004|Participant Flow|Control (In Cohort 1-4)|Control subjects in Cohort 1 to 4 received standard of care (no strip) for pain control.
11182709|NCT02077140|OG000|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
11182710|NCT02077140|OG001|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
11182711|NCT02077140|OG002|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
11182712|NCT02077140|OG003|Outcome|Control (In Cohort 1-3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
11182713|NCT02077140|OG003|Outcome|Control (In Cohort 1 to 3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
11182714|NCT02077140|OG003|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
11182715|NCT02077140|OG003|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
11182716|NCT02077140|OG004|Outcome|Control (In Cohort 1 to 4)|Control subjects of Cohort 1 to 4 received standard of care for pain control.
11182717|NCT02077140|EG000|Reported Event|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
11182718|NCT02077140|EG001|Reported Event|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
11182719|NCT02077140|EG002|Reported Event|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
11182720|NCT02077140|EG003|Reported Event|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
11182721|NCT02077140|EG004|Reported Event|Control (In Cohort 1 to 4)|Control subjects in Cohort 1 to 4 received standard of care (no strip) for pain control.
11182722|NCT02077374|BG000|Baseline|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
11182723|NCT02077374|BG001|Baseline|Placebo|"Placebo~Matching Placebo BID for 28 days"
11182724|NCT02077374|BG002|Baseline|Total|Total of all reporting groups
11182725|NCT02077374|FG000|Participant Flow|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
11182726|NCT02077374|FG001|Participant Flow|Placebo|"Placebo~Matching Placebo BID for 28 days"
11182727|NCT02077374|OG000|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
11182728|NCT02077374|OG001|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
11182729|NCT02077374|OG000|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg Twice daily for 28 days"
11182730|NCT02077374|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo Twice daily for 28 Days"
11182731|NCT02077374|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo BID for 28 Days"
11182732|NCT02077374|EG000|Reported Event|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
11182733|NCT02077374|EG001|Reported Event|Placebo|"Placebo~Matching Placebo BID for 28 days"
11182734|NCT02077465|BG000|Baseline|Andecaliximab|Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
11182735|NCT02077465|BG001|Baseline|Placebo|Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
11182736|NCT02077465|BG002|Baseline|Total|Total of all reporting groups
11182737|NCT02077465|FG000|Participant Flow|Andecaliximab|Participants received intravenous (IV) infusion of andecaliximab (400 mg) once every 2 weeks for a total of 3 infusions.
11182738|NCT02077465|FG001|Participant Flow|Placebo|Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
11182739|NCT02077465|OG000|Outcome|Andecaliximab|Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
11182740|NCT02077465|OG001|Outcome|Placebo|Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
11182741|NCT02077465|EG000|Reported Event|Andecaliximab|Participants received IV infusion of andecaliximab 200 mg once every 2 weeks for a total of 3 infusions.
11182742|NCT02077465|EG001|Reported Event|Placebo|Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
11182743|NCT02078102|BG000|Baseline|Multiple Myeloma|"This is for the patients with Multiple Myeloma.~Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11182744|NCT02078102|BG001|Baseline|Non Hodgkins Lymphoma|"This is for the patients with Non Hodgkins Lymphoma.~Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11182745|NCT02078102|BG002|Baseline|Total|Total of all reporting groups
11182746|NCT02078102|FG000|Participant Flow|Multiple Myeloma|"This is for the patients with Multiple Myeloma.~Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11182747|NCT02078102|FG001|Participant Flow|Non Hodgkins Lymphoma|"This is for the patients with Non Hodgkins Lymphoma.~Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11182748|NCT02078102|OG000|Outcome|Multiple Myeloma|"This is for the patients with Multiple Myeloma.~Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11182749|NCT02078102|OG001|Outcome|Non Hodgkins Lymphoma|"This is for the patients with Non Hodgkins Lymphoma.~Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11191390|NCT02132247|BG001|Baseline|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
11191391|NCT02132247|BG002|Baseline|Total|Total of all reporting groups
11182750|NCT02078102|OG000|Outcome|Treatment Group|"Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11182751|NCT02078102|EG000|Reported Event|Multiple Myeloma|"This is for the patients with Multiple Myeloma.~Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11182752|NCT02078102|EG001|Reported Event|Non Hodgkins Lymphoma|"This is for the patients with Non Hodgkins Lymphoma.~Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.~15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.~10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.~Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.~Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home."
11182753|NCT02078180|BG000|Baseline|IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300|Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
11182754|NCT02078180|FG000|Participant Flow|IR75, IR200, SR100, SR150, XL150, XL300|Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
11182755|NCT02078180|OG000|Outcome|Generic Bupropion IR75|"One oral dose of generic bupropion IR75~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
11182756|NCT02078180|OG001|Outcome|Generic Bupropion IR100|"One oral dose of generic bupropion IR100~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
11182757|NCT02078180|OG002|Outcome|Generic Bupropion SR100|"One oral dose of generic bupropion SR100~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
11182758|NCT02078180|OG003|Outcome|Generic Bupropion SR150|"One oral dose of generic bupropion SR150~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
11182759|NCT02078180|OG004|Outcome|Generic Bupropion XL150|"One oral dose of generic bupropion XL150~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
11182760|NCT02078180|OG005|Outcome|Generic Bupropion XL300|"One oral dose of generic bupropion XL300~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
11182761|NCT02078180|EG000|Reported Event|IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300|Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
11182762|NCT02078193|BG000|Baseline|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
11182763|NCT02078193|FG000|Participant Flow|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
11182764|NCT02078193|OG000|Outcome|Belatacept|"Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept~Belatacept: Patients will be converted from their MMF to Belatacept"
11182765|NCT02078193|OG000|Outcome|Belatacept|Participants who received Belatacept by IV infusion.
11182766|NCT02078193|EG000|Reported Event|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
11182767|NCT02078219|BG000|Baseline|Allopurinol 200 mg Treatment Group|100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks
11182768|NCT02078219|BG001|Baseline|RDEA3170 Placebo Treatment Group|RDEA3170 matching placebo qd for 24 weeks
11182769|NCT02078219|BG002|Baseline|RDEA3170 Treatment Group 1|RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
11182770|NCT02078219|BG003|Baseline|RDEA3170 Treatment Group 2|RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
11182771|NCT02078219|BG004|Baseline|RDEA3170 Treatment Group 3|RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
11182772|NCT02078219|BG005|Baseline|Total|Total of all reporting groups
11182773|NCT02078219|FG000|Participant Flow|Allopurinol 200 mg Treatment Group|100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks
11182774|NCT02078219|FG001|Participant Flow|RDEA3170 Placebo Treatment Group|RDEA3170 matching placebo qd for 24 weeks
11182775|NCT02078219|FG002|Participant Flow|RDEA3170 Treatment Group 1|RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
11182776|NCT02078219|FG003|Participant Flow|RDEA3170 Treatment Group 2|RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
11182777|NCT02078219|FG004|Participant Flow|RDEA3170 Treatment Group 3|RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
11182778|NCT02078219|OG000|Outcome|RDEA3170 Treatment Group 1|RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
11182779|NCT02078219|OG001|Outcome|RDEA3170 Treatment Group 2|RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
11182780|NCT02078219|OG002|Outcome|RDEA3170 Treatment Group 3|RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
11182781|NCT02078219|OG003|Outcome|RDEA3170 Placebo Treatment Group|RDEA3170 matching placebo qd for 24 weeks
11182782|NCT02078219|OG004|Outcome|Allopurinol 200 mg Treatment Group|Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
11182783|NCT02078219|EG000|Reported Event|Allopurinol 200 mg Treatment Group|allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks.
11182784|NCT02078219|EG001|Reported Event|RDEA3170 Placebo Treatment Group|RDEA3170 matching placebo qd for 24 weeks
11182785|NCT02078219|EG002|Reported Event|RDEA3170 Treatment Group 1|RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
11182786|NCT02078219|EG003|Reported Event|RDEA3170 Treatment Group 2|RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
11182787|NCT02078219|EG004|Reported Event|RDEA3170 Treatment Group 3|RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
11182788|NCT02078284|BG000|Baseline|Cohort 1 With 0.5 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182789|NCT02078284|BG001|Baseline|Cohort 2 With 1 Unit of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182790|NCT02078284|BG002|Baseline|Cohort 3 With 2 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182791|NCT02078284|BG003|Baseline|Cohort 4 With 3 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182792|NCT02078284|BG004|Baseline|1 Unit of LSP|A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
11182793|NCT02078284|BG005|Baseline|Total|Total of all reporting groups
11182794|NCT02078284|FG000|Participant Flow|Cohort 1 With 0.5 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182795|NCT02078284|FG001|Participant Flow|Cohort 2 With 1 Unit of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182796|NCT02078284|FG002|Participant Flow|Cohort 3 With 2 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182797|NCT02078284|FG003|Participant Flow|Cohort 4 With 3 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182798|NCT02078284|FG004|Participant Flow|1 Unit of LSP|A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
11182799|NCT02078284|OG000|Outcome|Cohort 1 With 0.5 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182800|NCT02078284|OG001|Outcome|Cohort 2 With 1 Unit of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182801|NCT02078284|OG002|Outcome|Cohort 3 With 2 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182802|NCT02078284|OG003|Outcome|Cohort 4 With 3 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182803|NCT02078284|OG004|Outcome|1 Unit of LSP|A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
11182804|NCT02078284|EG000|Reported Event|Cohort 1 With 0.5 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182805|NCT02078284|EG001|Reported Event|Cohort 2 With 1 Unit of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182806|NCT02078284|EG002|Reported Event|Cohort 3 With 2 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182807|NCT02078284|EG003|Reported Event|Cohort 4 With 3 Units of CPP|"A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)~CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C."
11182808|NCT02078284|EG004|Reported Event|1 Unit of LSP|A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
11182809|NCT02078492|BG000|Baseline|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
11182810|NCT02078492|BG001|Baseline|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
11182811|NCT02078492|BG002|Baseline|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
11182812|NCT02078492|BG003|Baseline|Total|Total of all reporting groups
11182813|NCT02078492|FG000|Participant Flow|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
11182814|NCT02078492|FG001|Participant Flow|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
11182815|NCT02078492|FG002|Participant Flow|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
11182816|NCT02078492|OG000|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
11182817|NCT02078492|OG001|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
11182818|NCT02078492|OG002|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
11182819|NCT02078492|EG000|Reported Event|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
11182820|NCT02078492|EG001|Reported Event|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
11182821|NCT02078492|EG002|Reported Event|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
11182822|NCT02078557|BG000|Baseline|MK-8892|MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
11182823|NCT02078557|FG000|Participant Flow|MK-8892|MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
11182824|NCT02078557|OG000|Outcome|MK-8892|MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
11182825|NCT02078557|EG000|Reported Event|MK-8892|MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
11235297|NCT02442271|OG004|Outcome|Pegylated Interferon (PegIFN)/RBV Relapser|Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
11235298|NCT02442271|OG005|Outcome|Pegylated Interferon (PegIFN)/RBV Breakthrough|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
11235299|NCT02442271|OG006|Outcome|IFN Interolerant|Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
11235300|NCT02442271|OG007|Outcome|Other|Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
11235301|NCT02442271|OG000|Outcome|Interferon (IFN)-Ineligible, Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection and were ineligible for treatment with IFN at screening.
11235302|NCT02442271|OG001|Outcome|Interferon (IFN)-Eligible, Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection and were eligible for treatment with IFN at screening.
11235303|NCT02442271|OG002|Outcome|Interferon (IFN)-Ineligible, Treatment-Experienced|Participants who had received prior antiviral treatment for HCV infection and were ineligible for treatment with IFN at screening.
11235304|NCT02442271|OG003|Outcome|Interferon (IFN)-Eligible, Treatment-Experienced|Participants who had received prior antiviral treatment for HCV infection and were eligible for treatment with IFN at screening.
11235305|NCT02442271|EG000|Reported Event|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
11235306|NCT02442284|BG000|Baseline|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
11235307|NCT02442284|FG000|Participant Flow|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
11235308|NCT02442284|OG000|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
11235309|NCT02442284|EG000|Reported Event|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
11235310|NCT02442310|BG000|Baseline|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:~Deferiprone delayed release tablets under fed conditions.~Deferiprone delayed release tablets under fasting conditions.~Deferiprone delayed release tablets administered as half-tablets, under fed conditions.~Deferiprone oral solution under fasting conditions"
11235311|NCT02442310|FG000|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:~Deferiprone delayed release tablets under fed conditions.~Deferiprone delayed release tablets under fasting conditions.~Deferiprone delayed release tablets administered as half-tablets, under fed conditions.~Deferiprone oral solution under fasting conditions"
11235312|NCT02442310|OG000|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
11235313|NCT02442310|OG001|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
11235314|NCT02442310|OG002|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
11235315|NCT02442310|OG003|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
11235316|NCT02442310|EG000|Reported Event|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
11235317|NCT02442310|EG001|Reported Event|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
11235318|NCT02442310|EG002|Reported Event|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
11235319|NCT02442310|EG003|Reported Event|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
11235320|NCT02442336|BG000|Baseline|My Journey AHead|Participants were provided access to a web-base intervention that included several modules on oral care, stress and coping, nutrition, and pain management.
11341794|NCT03688620|BG000|Baseline|Vaccinated_AlphaRix Tetra Group|Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
11182826|NCT02078713|BG000|Baseline|Contraceptive Decision Support Tool Patients|"Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit.~Contraceptive Decision Support Tool: The decision support tool:~Provides an educational session about different aspects of contraception~Elicits patient preferences about different aspects of contraception~Identifies potential contraindications to certain contraceptive methods~Allows the patient to view details about and compare available contraceptive methods~Suggests methods most appropriate based on the patient's preferences~Collects questions the patient may have for her provider~Generates a printout the patient can bring to her contraceptive counseling visit"
11182827|NCT02078713|BG001|Baseline|Usual Care (Control) Patients|Patients in this arm will receive usual family planning care.
11182828|NCT02078713|BG002|Baseline|Contraception Decision Support Tool Providers|Family planning providers randomized to use the Contraceptive Decision Support tool with their patients. Providers were the unit of randomization in this cluster trial
11182829|NCT02078713|BG003|Baseline|Usual Care (Control) Providers|Family planning providers randomized to practice usual care with their patients. Providers were the unit of randomization in this cluster trial
11182830|NCT02078713|BG004|Baseline|Total|Total of all reporting groups
11182831|NCT02078713|FG000|Participant Flow|Contraceptive Decision Support Tool Patients|"Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit.~Contraceptive Decision Support Tool: The decision support tool:~Provides an educational session about different aspects of contraception~Elicits patient preferences about different aspects of contraception~Identifies potential contraindications to certain contraceptive methods~Allows the patient to view details about and compare available contraceptive methods~Suggests methods most appropriate based on the patient's preferences~Collects questions the patient may have for her provider~Generates a printout the patient can bring to her contraceptive counseling visit"
11182832|NCT02078713|FG001|Participant Flow|Usual Care (Control) Patients|Patients in this arm will receive usual family planning care.
11182833|NCT02078713|FG002|Participant Flow|Contraceptive Decision Support Tool Providers|Family planning providers randomized to use the Contraceptive Decision Support tool with their patients in the study.
11182834|NCT02078713|FG003|Participant Flow|Usual Care (Control) Providers|Family planning providers randomized to deliver usual care to their patient in the study.
11182835|NCT02078713|OG000|Outcome|Contraceptive Decision Support Tool|"Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit.~Contraceptive Decision Support Tool: The decision support tool:~Provides an educational session about different aspects of contraception~Elicits patient preferences about different aspects of contraception~Identifies potential contraindications to certain contraceptive methods~Allows the patient to view details about and compare available contraceptive methods~Suggests methods most appropriate based on the patient's preferences~Collects questions the patient may have for her provider~Generates a printout the patient can bring to her contraceptive counseling visit"
11182836|NCT02078713|OG001|Outcome|Usual Care (Control)|Patients in this arm will receive usual family planning care.
11182837|NCT02078713|OG000|Outcome|Contraceptive Decision Support Tool Patients|"Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit.~Contraceptive Decision Support Tool: The decision support tool:~Provides an educational session about different aspects of contraception~Elicits patient preferences about different aspects of contraception~Identifies potential contraindications to certain contraceptive methods~Allows the patient to view details about and compare available contraceptive methods~Suggests methods most appropriate based on the patient's preferences~Collects questions the patient may have for her provider~Generates a printout the patient can bring to her contraceptive counseling visit"
11182838|NCT02078713|OG001|Outcome|Usual Care (Control) Patients|Patients in this arm will receive usual family planning care.
11182839|NCT02078713|OG000|Outcome|Contraceptive Decision Support Tool Providers|Providers randomized to use the contraceptive decision support tool and to use to the tool with their patients participating in the study.
11182840|NCT02078713|OG001|Outcome|Usual Care Providers|Providers randomized to practice usual care with their patients participating in the study.
11182841|NCT02078713|EG000|Reported Event|Contraceptive Decision Support Tool Patients|"Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit.~Contraceptive Decision Support Tool: The decision support tool:~Provides an educational session about different aspects of contraception~Elicits patient preferences about different aspects of contraception~Identifies potential contraindications to certain contraceptive methods~Allows the patient to view details about and compare available contraceptive methods~Suggests methods most appropriate based on the patient's preferences~Collects questions the patient may have for her provider~Generates a printout the patient can bring to her contraceptive counseling visit"
11182842|NCT02078713|EG001|Reported Event|Usual Care (Control) Patients|Patients in this arm will receive usual family planning care.
11182843|NCT02078713|EG002|Reported Event|Contraceptive Decision Support Tool Providers|Providers randomized to use the tool with their study patients.
11182844|NCT02078713|EG003|Reported Event|Usual Care (Control) Providers|Providers randomized to deliver usual care to their study patients.
11182845|NCT02078726|BG000|Baseline|Glucagon|"1 mg glucagon given during colonoscopy~Glucagon: glucagon (hormone produced by the body)"
11182846|NCT02078726|BG001|Baseline|Placebo|"1 mL normal saline~Placebo"
11182847|NCT02078726|BG002|Baseline|Total|Total of all reporting groups
11182848|NCT02078726|FG000|Participant Flow|Glucagon|"1 mg glucagon given during colonoscopy~Glucagon: glucagon (hormone produced by the body)"
11182849|NCT02078726|FG001|Participant Flow|Placebo|"1 mL normal saline~Placebo"
11182850|NCT02078726|OG000|Outcome|Glucagon|"1 mg glucagon given during colonoscopy~Glucagon: glucagon (hormone produced by the body)"
11182851|NCT02078726|OG001|Outcome|Placebo|"1 mL normal saline~Placebo"
11182852|NCT02078726|EG000|Reported Event|Glucagon|"1 mg glucagon given during colonoscopy~Glucagon: glucagon (hormone produced by the body)"
11182853|NCT02078726|EG001|Reported Event|Placebo|"1 mL normal saline~Placebo"
11182854|NCT02078752|BG000|Baseline|PF-06647263 0.01 mg/kg QW (Part 1)|Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182855|NCT02078752|BG001|Baseline|PF-06647263 0.015 mg/kg QW (Part 1)|Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182856|NCT02078752|BG002|Baseline|PF-06647263 0.015 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182857|NCT02078752|BG003|Baseline|PF-06647263 0.02 mg/kg QW (Part 1)|Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182858|NCT02078752|BG004|Baseline|PF-06647263 0.03 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182859|NCT02078752|BG005|Baseline|PF-06647263 0.05 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182860|NCT02078752|BG006|Baseline|PF-06647263 0.075 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182861|NCT02078752|BG007|Baseline|PF-06647263 0.1 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182862|NCT02078752|BG008|Baseline|PF-06647263 0.134 mg/kg QW (Part 1)|Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182863|NCT02078752|BG009|Baseline|PF-06647263 0.015 mg/kg QW (Part 2)|Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
11182864|NCT02078752|BG010|Baseline|Total|Total of all reporting groups
11182865|NCT02078752|FG000|Participant Flow|PF-06647263 0.01 mg/kg QW (Part 1)|Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182866|NCT02078752|FG001|Participant Flow|PF-06647263 0.015 mg/kg QW (Part 1)|Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182867|NCT02078752|FG002|Participant Flow|PF-06647263 0.015 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182868|NCT02078752|FG003|Participant Flow|PF-06647263 0.02 mg/kg QW (Part 1)|Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182869|NCT02078752|FG004|Participant Flow|PF-06647263 0.03 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182870|NCT02078752|FG005|Participant Flow|PF-06647263 0.05 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182871|NCT02078752|FG006|Participant Flow|PF-06647263 0.075 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182872|NCT02078752|FG007|Participant Flow|PF-06647263 0.1 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182873|NCT02078752|FG008|Participant Flow|PF-06647263 0.134 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182874|NCT02078752|FG009|Participant Flow|PF-06647263 0.015 mg/kg QW (Part 2)|Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
11182875|NCT02078752|OG000|Outcome|PF-06647263 0.01 mg/kg QW (Part 1)|Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182876|NCT02078752|OG001|Outcome|PF-06647263 0.015 mg/kg QW (Part 1)|Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182877|NCT02078752|OG002|Outcome|PF-06647263 0.015 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182878|NCT02078752|OG003|Outcome|PF-06647263 0.02 mg/kg QW (Part 1)|Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182879|NCT02078752|OG004|Outcome|PF-06647263 0.03 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182880|NCT02078752|OG005|Outcome|PF-06647263 0.05 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182881|NCT02078752|OG006|Outcome|PF-06647263 0.075 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182882|NCT02078752|OG007|Outcome|PF-06647263 0.1 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182883|NCT02078752|OG008|Outcome|PF-06647263 0.134 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182884|NCT02078752|OG000|Outcome|PF-06647263 0.015 mg/kg QW (Part 2)|Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
11182885|NCT02078752|OG009|Outcome|PF-06647263 0.015 mg/kg QW (Part 2)|Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
11182886|NCT02078752|OG002|Outcome|PF-06647263 0.02 mg/kg QW (Part 1)|Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182887|NCT02078752|OG003|Outcome|PF-06647263 0.015 mg/kg QW (Part 2)|Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
11182888|NCT02078752|OG000|Outcome|PF-06647263 0.015 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182889|NCT02078752|OG001|Outcome|PF-06647263 0.03 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182890|NCT02078752|OG002|Outcome|PF-06647263 0.05 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182891|NCT02078752|OG003|Outcome|PF-06647263 0.075 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182892|NCT02078752|OG004|Outcome|PF-06647263 0.1 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182893|NCT02078752|OG005|Outcome|PF-06647263 0.134 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182894|NCT02078752|EG000|Reported Event|PF-06647263 0.01 mg/kg QW (Part 1)|Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182895|NCT02078752|EG001|Reported Event|PF-06647263 0.015 mg/kg QW (Part 1)|Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182896|NCT02078752|EG002|Reported Event|PF-06647263 0.015 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182897|NCT02078752|EG003|Reported Event|PF-06647263 0.02 mg/kg QW (Part 1)|Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182898|NCT02078752|EG004|Reported Event|PF-06647263 0.03 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11235321|NCT02442336|FG000|Participant Flow|My Journey AHead|"Several internet modules will be developed to address mouth and swallowing concerns, oral care, healthy eating, speech problems, coping with cancer, pain management, and physical therapy.~My Journey AHead: The intervention program will contain information and interactive activities around swallowing concerns, proper oral care, healthy eating and nutrition, speech issues, stress and coping with cancer, and pain management."
11235322|NCT02442336|OG000|Outcome|Web-Based Intervention|Participants were provided access to a web-base intervention that included several modules on oral care, stress and coping, nutrition, and pain management.
11235323|NCT02442336|EG000|Reported Event|My Journey AHead|"Several internet modules will be developed to address mouth and swallowing concerns, oral care, healthy eating, speech problems, coping with cancer, pain management, and physical therapy.~My Journey AHead: The intervention program will contain information and interactive activities around swallowing concerns, proper oral care, healthy eating and nutrition, speech issues, stress and coping with cancer, and pain management."
11235324|NCT02442622|BG000|Baseline|Occupational Therapy|"Traditional therapy for de Quervain's Tenosynovitis~Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis"
11235325|NCT02442622|BG001|Baseline|Occupational Therapy With ASTYM|"Traditional therapy for de Quervain's Tenosynovitis plus ASTYM~Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM"
11235326|NCT02442622|BG002|Baseline|Total|Total of all reporting groups
11235327|NCT02442622|FG000|Participant Flow|Occupational Therapy|"Traditional therapy for de Quervain's Tenosynovitis~Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis"
11235328|NCT02442622|FG001|Participant Flow|Occupational Therapy With ASTYM|"Traditional therapy for de Quervain's Tenosynovitis plus ASTYM~Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM"
11235329|NCT02442622|OG000|Outcome|Occupational Therapy|"Traditional therapy for de Quervain's Tenosynovitis~Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis"
11235330|NCT02442622|OG001|Outcome|Occupational Therapy With ASTYM|"Traditional therapy for de Quervain's Tenosynovitis plus ASTYM~Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM"
11235331|NCT02442622|EG000|Reported Event|Occupational Therapy|"Traditional therapy for de Quervain's Tenosynovitis~Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis"
11235332|NCT02442622|EG001|Reported Event|Occupational Therapy With ASTYM|"Traditional therapy for de Quervain's Tenosynovitis plus ASTYM~Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM"
11235333|NCT02442687|BG000|Baseline|JKB 5 mg BID|JKB 121, 5 mg twice daily
11235334|NCT02442687|BG001|Baseline|JKB 10 mg BID|JKB 121, 10 mg twice daily
11235335|NCT02442687|BG002|Baseline|Placebo BID|Identical appearing placebo
11235336|NCT02442687|BG003|Baseline|Total|Total of all reporting groups
11235337|NCT02442687|FG000|Participant Flow|JKB 5 mg BID|JKB 121, 5 mg by mouth twice daily
11235338|NCT02442687|FG001|Participant Flow|JKB 10 mg BID|JKB 121, 10 mg by mouth twice daily
11235339|NCT02442687|FG002|Participant Flow|Placebo BID|Identical appearing placebo by mouth twice daily
11235340|NCT02442687|OG000|Outcome|JKB 121, 5 mg|"JKB 121, 5 mg twice daily~JKB-121: 5 mg twice daily"
11235341|NCT02442687|OG001|Outcome|JKB-121: 10 mg|"JKB 121, 10 mg twice daily~JKB-121: 10 mg twice daily"
11235342|NCT02442687|OG002|Outcome|Placebo|"Identical appearing placebo~Placebo"
11235343|NCT02442687|OG001|Outcome|JKB 121, 10 mg|"JKB 121, 10 mg twice daily~JKB-121: 10 mg twice daily"
11235344|NCT02442687|EG000|Reported Event|JKB 5 mg Twice Daily|JKB 121, 5 mg twice daily
11235345|NCT02442687|EG001|Reported Event|Placebo Twice Daily|Placebo, twice daily
11235346|NCT02442687|EG002|Reported Event|JKB 121 10 mg Twice Daily|JKB 121, 10 mg twice daily
11235347|NCT02442700|BG000|Baseline|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
11235348|NCT02442700|BG001|Baseline|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
11235349|NCT02442700|BG002|Baseline|Total|Total of all reporting groups
11235350|NCT02442700|FG000|Participant Flow|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
11235351|NCT02442700|FG001|Participant Flow|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
11235352|NCT02442700|OG000|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
11235353|NCT02442700|OG001|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
11235354|NCT02442700|EG000|Reported Event|Treatment A|Treatment A = administration pitavastatin for 12 weeks
11235355|NCT02442700|EG001|Reported Event|Treatment B|Treatment B = administration placebo for 12 weeks
11235356|NCT02442804|BG000|Baseline|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
11235357|NCT02442804|BG001|Baseline|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
11235358|NCT02442804|BG002|Baseline|Total|Total of all reporting groups
11235359|NCT02442804|FG000|Participant Flow|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
11235360|NCT02442804|FG001|Participant Flow|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
11235361|NCT02442804|OG000|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
11235362|NCT02442804|OG001|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
11235363|NCT02442804|EG000|Reported Event|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
11235364|NCT02442804|EG001|Reported Event|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
11235365|NCT02442830|BG000|Baseline|Early Video Capsule Endoscopy|"The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.~Early Video Capsule Endoscopy: The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract.~Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic me"
11235366|NCT02442830|BG001|Baseline|Standard of Care Workup Group|"In this arm, patients will receive standard of care workup for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of standard of care workup the patients will be given the same Olympus video capsule that is used in the Early Capsule group."
11235367|NCT02442830|BG002|Baseline|Total|Total of all reporting groups
11235368|NCT02442830|FG000|Participant Flow|Early Video Capsule Endoscopy|"The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.~Early VC Endoscopy (VCE): The intervention is the use of VCE as the first test in a patient presenting to the Emergency Department (ED) with active bleeding. The capsule allows for visualization of the entire bowel. Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the VCE and make a decision regarding which therapeutic measure to pursue."
11235369|NCT02442830|FG001|Participant Flow|Standard of Care Workup Group|"In this arm, patients will receive standard of care workup for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of standard of care workup the patients will be given the same Olympus video capsule that is used in the Early Capsule group."
11235370|NCT02442830|OG000|Outcome|Early Video Capsule Endoscopy|"The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.~Early Video Capsule Endoscopy: The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract.~Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic me"
11235371|NCT02442830|OG001|Outcome|Standard of Care Workup Group|"In this arm, patients will receive standard of care workup for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of standard of care workup the patients will be given the same Olympus video capsule that is used in the Early Capsule group."
11235372|NCT02442830|OG000|Outcome|Early Video Capsule Endoscopy|"The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.~Early Video Capsule Endoscopy: The intervention is the use of VC endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract.~Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic measure to pursue."
11235373|NCT02442830|EG000|Reported Event|Early Video Capsule Endoscopy|"The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the emergency department. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.~Early Video Capsule Endoscopy: The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract.~Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic me"
11341795|NCT03688620|BG001|Baseline|Vaccinated_Influsplit Tetra Group|"Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between~01 October and 31 December 2018."
11182899|NCT02078752|EG005|Reported Event|PF-06647263 0.05 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182900|NCT02078752|EG006|Reported Event|PF-06647263 0.075 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182901|NCT02078752|EG007|Reported Event|PF-06647263 0.1 mg/kg Q3W (Part 1)|Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182902|NCT02078752|EG008|Reported Event|PF-06647263 0.134 mg/kg QW (Part 1)|Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
11182903|NCT02078752|EG009|Reported Event|PF-06647263 0.015 mg/kg QW (Part 2)|Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
11182904|NCT02078817|BG000|Baseline|Ketamine|"Intravenous ketamine 0.5 mg/kg over 40 minutes will be given 6 times over 2 weeks.~Ketamine: IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period."
11182905|NCT02078817|FG000|Participant Flow|Ketamine|"Intravenous ketamine 0.5 mg/kg over 40 minutes will be given 6 times over 2 weeks.~Ketamine: IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period."
11182906|NCT02078817|OG000|Outcome|Ketamine|"Intravenous ketamine 0.5 mg/kg over 40 minutes will be given 6 times over 2 weeks.~Ketamine: IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period."
11182907|NCT02078817|EG000|Reported Event|Ketamine|"Intravenous ketamine 0.5 mg/kg over 40 minutes will be given 6 times over 2 weeks.~Ketamine: IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period."
11182908|NCT02078882|BG000|Baseline|Abatacept 125 mg Weekly|"Open label treatment with Abatacept~abatacept: 125 mg subcutaneously each week for 24 weeks"
11182909|NCT02078882|FG000|Participant Flow|Abatacept 125 mg Weekly|"Open label treatment with Abatacept~abatacept: 125 mg subcutaneously each week for 24 weeks"
11182910|NCT02078882|OG000|Outcome|Abatacept 125 mg Weekly|"Open label treatment with Abatacept~abatacept: 125 mg subcutaneously each week for 24 weeks"
11182911|NCT02078882|EG000|Reported Event|Abatacept 125 mg Weekly|"Open label treatment with Abatacept~abatacept: 125 mg subcutaneously each week for 24 weeks"
11182912|NCT02078960|BG000|Baseline|Cohort 1|Participants whose body surface area (BSA) is less than 1.7 m^2. All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182913|NCT02078960|BG001|Baseline|Cohort 2|Participants whose body surface area (BSA) is between 1.7 m^2 to 2.0 m^2 inclusive All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182914|NCT02078960|BG002|Baseline|Cohort 3|Participants whose body surface area (BSA) is greater than 2.0 m^2. All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182915|NCT02078960|BG003|Baseline|Total|Total of all reporting groups
11182916|NCT02078960|FG000|Participant Flow|Cohort 1|Participants whose body surface area (BSA) is less than 1.7 m^2. All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11191392|NCT02132247|FG000|Participant Flow|Flector Patch/Age 6-11|Flector Patch is a topical delivery system containing 180 mg of diclofenac epolamine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
11191393|NCT02132247|FG001|Participant Flow|Flector Patch/Age 12-16|Flector Patch is a topical delivery system containing 180 mg of diclofenac epolamine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
11182917|NCT02078960|FG001|Participant Flow|Cohort 2|Participants whose body surface area (BSA) is between 1.7 m^2 to 2.0 m^2 inclusive All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182918|NCT02078960|FG002|Participant Flow|Cohort 3|Participants whose body surface area (BSA) is greater than 2.0 m^2. All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182919|NCT02078960|OG000|Outcome|Cohort 1|Participants whose body surface area (BSA) is less than 1.7 m^2. All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182920|NCT02078960|OG001|Outcome|Cohort 2|Participants whose body surface area (BSA) is between 1.7 m^2 to 2.0 m^2 inclusive All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182921|NCT02078960|OG002|Outcome|Cohort 3|Participants whose body surface area (BSA) is greater than 2.0 m^2. All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182922|NCT02078960|OG000|Outcome|All Enrolled Participants|All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182923|NCT02078960|OG000|Outcome|Total Omacetaxine|All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily. Induction cycles of 14 days twice daily treatment were followed by 14 days without treatment (1 induction cycle) for as long as they adequately recover their blood counts and/or until they achieve hematologic response. [Cycle 1 was an exception since participants were not dosed a second time on Day 1, nor at all on Days 2+3 to accommodate the PK study objective.] Participants then received maintenance cycles of 7 days twice daily treatment followed by 21 days without treatment (1 maintenance cycle) for as long as they continued to benefit up to a period of 12 months following the first dose.
11182924|NCT02078960|EG000|Reported Event|COHORT 1|Participants whose body surface area (BSA) is less than 1.7 m^2. All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily.
11182925|NCT02078960|EG001|Reported Event|COHORT 2|Participants whose body surface area (BSA) is between 1.7 m^2 to 2.0 m^2 inclusive All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily.
11182926|NCT02078960|EG002|Reported Event|COHORT 3|Participants whose body surface area (BSA) is greater than 2.0 m^2. All participants were given a fixed dose of 2.5 mg omacetaxine by subcutaneous injection twice daily.
11182927|NCT02079025|BG000|Baseline|LR-TRUS|"Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)~Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system"
11182928|NCT02079025|BG001|Baseline|UHR-TRUS|"Ultra-high resolution transrectal ultrasound guided prostate biopsy~High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system"
11182929|NCT02079025|BG002|Baseline|Total|Total of all reporting groups
11182930|NCT02079025|FG000|Participant Flow|LR-TRUS|"Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)~Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system"
11182931|NCT02079025|FG001|Participant Flow|UHR-TRUS|"Ultra-high resolution transrectal ultrasound guided prostate biopsy~High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system"
11182932|NCT02079025|OG000|Outcome|LR-TRUS|"Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)~Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system"
11182933|NCT02079025|OG001|Outcome|UHR-TRUS|"Ultra-high resolution transrectal ultrasound guided prostate biopsy~High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system"
11182934|NCT02079025|OG000|Outcome|UHR-TRUS|"Ultra-high resolution transrectal ultrasound guided prostate biopsy~High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system"
11182935|NCT02079025|EG000|Reported Event|LR-TRUS|"Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)~Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system"
11182936|NCT02079025|EG001|Reported Event|UHR-TRUS|"Ultra-high resolution transrectal ultrasound guided prostate biopsy~High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system"
11182937|NCT02079038|BG000|Baseline|Totalis|Totalis ™ Direct Decompression Procedure
11182938|NCT02079038|BG001|Baseline|Control Procedure|Comparator Surgical Procedure
11182939|NCT02079038|BG002|Baseline|Total|Total of all reporting groups
11182940|NCT02079038|FG000|Participant Flow|Totalis|Totalis™ Direct Decompression Procedure
11182941|NCT02079038|FG001|Participant Flow|Control Procedure|Comparator Surgical Procedure
11182942|NCT02079038|OG000|Outcome|Totalis|Totalis ™ Direct Decompression Procedure
11182943|NCT02079038|OG001|Outcome|Control Procedure|Comparator Surgical Procedure
11182944|NCT02079038|EG000|Reported Event|Totalis|Totalis™ Direct Decompression Procedure
11182945|NCT02079038|EG001|Reported Event|Control Procedure|Comparator Surgical Procedure
11182946|NCT02079077|BG000|Baseline|Acetylsalicylic Acid (ASA)|"ASA 81 mg. p.o. daily for two months~Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months"
11182947|NCT02079077|BG001|Baseline|Hydroxychloroquine (HCQ)|"Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months.~Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months."
11182948|NCT02079077|BG002|Baseline|Total|Total of all reporting groups
11182949|NCT02079077|FG000|Participant Flow|Acetylsalicylic Acid (ASA)|"ASA 81 mg. p.o. daily for two months~Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months"
11182950|NCT02079077|FG001|Participant Flow|Hydroxychloroquine (HCQ)|"Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months.~Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months."
11182951|NCT02079077|OG000|Outcome|Acetylsalicylic Acid (ASA)|"ASA 81 mg. p.o. daily for two months~Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months"
11182952|NCT02079077|OG001|Outcome|Hydroxychloroquine (HCQ)|"Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months.~Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months."
11182953|NCT02079077|EG000|Reported Event|Acetylsalicylic Acid (ASA)|"ASA 81 mg. p.o. daily for two months~Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months"
11182954|NCT02079077|EG001|Reported Event|Hydroxychloroquine (HCQ)|"Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months.~Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months."
11182955|NCT02079246|BG000|Baseline|Idalopirdine 60 mg|Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
11182956|NCT02079246|FG000|Participant Flow|Idalopirdine 60 mg|Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
11182957|NCT02079246|FG001|Participant Flow|Idalopirdine 60 mg + Memantine|Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
11182958|NCT02079246|OG000|Outcome|Idalopirdine 60 mg|Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
11182959|NCT02079246|OG000|Outcome|Idalopirdine 60 mg + Memantine|Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
11182960|NCT02079246|OG000|Outcome|Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A|"Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.~Patients from lead-in Study 14681A"
11182961|NCT02079246|OG001|Outcome|Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A|"Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.~Patients from lead-in Study 14682A"
11182962|NCT02079246|OG000|Outcome|Idalopirdine 60 mg + Memantine (OLEX-MEM)|Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
11191394|NCT02132247|OG000|Outcome|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
11235374|NCT02442830|EG001|Reported Event|Standard of Care Workup Group|"In this arm, patients will receive standard of care workup for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of standard of care workup the patients will be given the same Olympus video capsule that is used in the Early Capsule group."
11235375|NCT02442856|BG000|Baseline|Intervention|We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
11235376|NCT02442856|FG000|Participant Flow|Intervention|We will measure dynamic cerebral autoregulation (dCA) with both transcranial doppler (TCD) and diffuse correlation spectroscopy (DCS) during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
11235377|NCT02442856|OG000|Outcome|Intervention|We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
11235378|NCT02442856|EG000|Reported Event|Intervention|We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
11235379|NCT02442869|BG000|Baseline|Stage 1 TAU (Participant Responding to Treatment)|"Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.~Participant responded to TAU, treatment ended."
11235380|NCT02442869|BG001|Baseline|Stage 1 CAMS (Participant Responding to Treatment)|"Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).~Participant responded to CAMS, treatment ended."
11235381|NCT02442869|BG002|Baseline|Stage 2 CAMS (Didn't Respond to Stage 1 TAU)|"Participant didn't respond to Stage 1 TAU and was re-randomized to:~Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"
11235382|NCT02442869|BG003|Baseline|Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)|"Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:~Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"
11235383|NCT02442869|BG004|Baseline|Stage 2 DBT (Didn't Respond to Stage 1 TAU)|"Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:~Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"
11235384|NCT02442869|BG005|Baseline|Stage 2 DBT (Didn't Respond to Stage 1 CAMS)|"Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:~Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"
11235385|NCT02442869|BG006|Baseline|Total|Total of all reporting groups
11235386|NCT02442869|FG000|Participant Flow|Stage 1 TAU (Participant Responding to Treatment)|"Treatment as usual [TAU] -- the treatment typically provided by the counselor for 4-8 weeks.~After 8 weeks or after participants completed their Stage 1 TAU treatment, whichever was later, they returned for their post Stage 1 assessment."
11235387|NCT02442869|FG001|Participant Flow|Stage 1 CAMS (Participant Responding to Treatment)|"Collaborative Assessment and Management of Suicidality [CAMs] -- treatment provided by counselor for 4-8 weeks.~After 8 weeks or after participants completed their Stage 1 CAMS treatment, whichever was later, they returned for their post Stage 1 assessment."
11235388|NCT02442869|FG002|Participant Flow|Stage 2 CAMS (Didn't Respond to Stage 1 TAU)|"Collaborative Assessment and Management of Suicidality (CAMS) -- treatment provided by counselor for 4-16 weeks.~16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 CAMS treatment, whichever was later, they returned for their post Stage 2 assessment."
11235389|NCT02442869|FG003|Participant Flow|Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)|"Collaborative Assessment and Management of Suicidality (CAMS) -- treatment provided by counselor for 4-16 weeks.~16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 CAMS treatment, whichever was later, they returned for their post Stage 2 assessment."
11235390|NCT02442869|FG004|Participant Flow|Stage 2 DBT (Didn't Respond to Stage 1 TAU)|"Dialectical Behavioral Therapy (DBT) course -- treatment provided by counselor for 4-16 weeks.~16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 DBT treatment, whichever was later, they returned for their post Stage 2 assessment."
11235391|NCT02442869|FG005|Participant Flow|Stage 2 DBT (Didn't Respond to Stage 1 CAMS)|"Dialectical Behavioral Therapy (DBT) course -- treatment provided by counselor for 4-16 weeks.~16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 DBT treatment, whichever was later, they returned for their post Stage 2 assessment."
11235392|NCT02442869|OG000|Outcome|Agreed to Participate|Number of eligible students approached who agreed to participate
11235393|NCT02442869|OG001|Outcome|Declined to Participate|Number of eligible students approached who declined to participate
11235394|NCT02442869|OG000|Outcome|Num. of Students Declining & Agreeing to Participate|Number of students who declined to participate in the study and why. Reasons eligible students declined participation in the study are detailed in the Pistorello et al., 2017 publication.
11235395|NCT02442869|OG000|Outcome|Stage 1 TAU (Participant Responding to Treatment)|"Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.~Participant responded to TAU, treatment ended."
11235396|NCT02442869|OG001|Outcome|Stage 1 CAMS (Participant Responding to Treatment)|"Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).~Participant responded to CAMS, treatment ended."
11182963|NCT02079246|EG000|Reported Event|Idalopirdine 60 mg|Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
11182964|NCT02079246|EG001|Reported Event|Idalopirdine 60 mg + Memantine|Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
11182965|NCT02079311|BG000|Baseline|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
11182966|NCT02079311|BG001|Baseline|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
11182967|NCT02079311|BG002|Baseline|Total|Total of all reporting groups
11182968|NCT02079311|FG000|Participant Flow|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
11182969|NCT02079311|FG001|Participant Flow|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
11182970|NCT02079311|OG000|Outcome|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
11182971|NCT02079311|OG001|Outcome|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
11182972|NCT02079311|EG000|Reported Event|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
11182973|NCT02079311|EG001|Reported Event|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
11182974|NCT02079519|BG000|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
11182975|NCT02079519|FG000|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
11182976|NCT02079519|OG000|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
11182977|NCT02079519|EG000|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
11191395|NCT02132247|OG001|Outcome|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
11191396|NCT02132247|EG000|Reported Event|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
11191397|NCT02132247|EG001|Reported Event|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
11191398|NCT02132312|BG000|Baseline|OMS302|"OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution~OMS302"
11191399|NCT02132312|BG001|Baseline|Phenylephrine HCl|"Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution~Phenylephrine HCl"
11191400|NCT02132312|BG002|Baseline|Total|Total of all reporting groups
11191401|NCT02132312|FG000|Participant Flow|OMS302|"OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution~OMS302"
11191402|NCT02132312|FG001|Participant Flow|Phenylephrine HCl|"Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution~Phenylephrine HCl"
11191403|NCT02132312|OG000|Outcome|OMS302|"OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution~OMS302"
11191404|NCT02132312|OG001|Outcome|Phenylephrine HCl|"Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution~Phenylephrine HCl"
11191405|NCT02132312|EG000|Reported Event|OMS302|"OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution~OMS302"
11191406|NCT02132312|EG001|Reported Event|Phenylephrine HCl|"Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution~Phenylephrine HCl"
11191407|NCT02132468|BG000|Baseline|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
11191408|NCT02132468|FG000|Participant Flow|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
11182978|NCT02079532|BG000|Baseline|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
11182979|NCT02079532|FG000|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab, 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
11182980|NCT02079532|OG000|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
11182981|NCT02079532|EG000|Reported Event|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
11182982|NCT02079610|BG000|Baseline|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
11182983|NCT02079610|BG001|Baseline|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
11182984|NCT02079610|BG002|Baseline|Total|Total of all reporting groups
11182985|NCT02079610|FG000|Participant Flow|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
11182986|NCT02079610|FG001|Participant Flow|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
11182987|NCT02079610|OG000|Outcome|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
11182988|NCT02079610|OG001|Outcome|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
11182989|NCT02079610|EG000|Reported Event|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
11182990|NCT02079610|EG001|Reported Event|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
11182991|NCT02079636|BG000|Baseline|Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11182992|NCT02079636|BG001|Baseline|Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11182993|NCT02079636|BG002|Baseline|Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11182994|NCT02079636|BG003|Baseline|Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11182995|NCT02079636|BG004|Baseline|Part C:150 mg Abemaciclib+10mg/kg Ramucirumab Day1|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11182996|NCT02079636|BG005|Baseline|Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11182997|NCT02079636|BG006|Baseline|Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11182998|NCT02079636|BG007|Baseline|Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11182999|NCT02079636|BG008|Baseline|Part D: 100 mg Abemaciclib + 100 mg LY3023414|100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183000|NCT02079636|BG009|Baseline|Part D: 150 mg Abemaciclib + 100 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183001|NCT02079636|BG010|Baseline|Part D: 150 mg Abemaciclib + 150 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183002|NCT02079636|BG011|Baseline|Part D: 200 mg Abemaciclib + 150 mg LY3023414|200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183003|NCT02079636|BG012|Baseline|Part D: 150 mg Abemaciclib + 200 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183004|NCT02079636|BG013|Baseline|Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab|100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183005|NCT02079636|BG014|Baseline|Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183006|NCT02079636|BG015|Baseline|Total|Total of all reporting groups
11183007|NCT02079636|FG000|Participant Flow|Part A: 150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed|150 mg abemaciclib given orally every 12 hours (Q12H) on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183008|NCT02079636|FG001|Participant Flow|Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183009|NCT02079636|FG002|Participant Flow|Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183010|NCT02079636|FG003|Participant Flow|Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183011|NCT02079636|FG004|Participant Flow|Part C: 150 mg Abemaciclib + 10mg/kg Ramucirumab Day 1|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183012|NCT02079636|FG005|Participant Flow|Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11191409|NCT02132468|OG000|Outcome|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
11183013|NCT02079636|FG006|Participant Flow|Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183014|NCT02079636|FG007|Participant Flow|Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183015|NCT02079636|FG008|Participant Flow|Part D: 100 mg Abemaciclib + 100 mg LY3023414|100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183016|NCT02079636|FG009|Participant Flow|Part D: 150 mg Abemaciclib + 100 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183017|NCT02079636|FG010|Participant Flow|Part D: 150 mg Abemaciclib + 150 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183018|NCT02079636|FG011|Participant Flow|Part D: 200 mg Abemaciclib + 150 mg LY3023414|200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183019|NCT02079636|FG012|Participant Flow|Part D: 150 mg Abemaciclib + 200 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183020|NCT02079636|FG013|Participant Flow|Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab|100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183021|NCT02079636|FG014|Participant Flow|Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183022|NCT02079636|OG000|Outcome|Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183023|NCT02079636|OG001|Outcome|Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183024|NCT02079636|OG002|Outcome|Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183025|NCT02079636|OG003|Outcome|Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183026|NCT02079636|OG004|Outcome|Part C:150 mg Abemaciclib+10 mg/kg Ramucirumab Day 1|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183027|NCT02079636|OG005|Outcome|Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183028|NCT02079636|OG006|Outcome|Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183029|NCT02079636|OG007|Outcome|Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183030|NCT02079636|OG008|Outcome|Part D: 100 mg Abemaciclib + 100 mg LY3023414|100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183031|NCT02079636|OG009|Outcome|Part D: 150 mg Abemaciclib + 100 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183032|NCT02079636|OG010|Outcome|Part D: 150 mg Abemaciclib + 150 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183033|NCT02079636|OG011|Outcome|Part D: 200 mg Abemaciclib + 150 mg LY3023414|200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183034|NCT02079636|OG012|Outcome|Part D: 150 mg Abemaciclib + 200 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183035|NCT02079636|OG013|Outcome|Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab|100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183036|NCT02079636|OG014|Outcome|Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183037|NCT02079636|OG004|Outcome|Part C:150 mg Abemaciclib+10mg/kg Ramucirumab Day1|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183038|NCT02079636|OG005|Outcome|Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183039|NCT02079636|OG006|Outcome|Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183040|NCT02079636|OG000|Outcome|Part A:Abemaciclib + 500 mg/m^2 Pemetrexed|150/200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183041|NCT02079636|OG001|Outcome|Part B: Abemaciclib + 1250 mg/m^2 Gemcitabine|150/200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183042|NCT02079636|OG002|Outcome|Part C:Abemaciclib+ 8/10mg/kg Ramucirumab Day1/8|150 /200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg /10 mg/kg ramucirumab / given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183043|NCT02079636|OG003|Outcome|Part D: Abemaciclib + 100 mg/150 mg/ 200 mg LY3023414|100 mg/ 150 mg / 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg / 150 mg/ 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183044|NCT02079636|OG004|Outcome|Part E: 100 mg/150 mg Abemaciclib + 200 mg Pembrolizumab|100 mg / 150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183045|NCT02079636|OG005|Outcome|Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183046|NCT02079636|OG006|Outcome|Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183047|NCT02079636|OG007|Outcome|Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183048|NCT02079636|OG000|Outcome|Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183049|NCT02079636|OG004|Outcome|Part C: 150 mg Abemaciclib + 8 mg/kg or 10 mg/kg Ramucirumab|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1, or 8 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8, or 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183050|NCT02079636|OG005|Outcome|Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day 1|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183051|NCT02079636|OG006|Outcome|Part D: 100 mg Abemaciclib + 100 mg LY3023414|100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183052|NCT02079636|OG007|Outcome|Part D: 150 mg Abemaciclib + 100 or 150 or 200 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 or 150 or 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183053|NCT02079636|OG008|Outcome|Part D: 200 mg Abemaciclib + 150 mg LY3023414|200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183054|NCT02079636|OG009|Outcome|Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab|100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183055|NCT02079636|OG010|Outcome|Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183056|NCT02079636|OG000|Outcome|Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183057|NCT02079636|OG001|Outcome|Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183058|NCT02079636|OG002|Outcome|Part B: 200 mg or MTD Abemaciclib + 1250 mg/m^2 Gemcitabine|200 mg abemaciclib or maximum tolerated dose (MTD) under the combination treatment abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183059|NCT02079636|OG000|Outcome|Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183060|NCT02079636|OG001|Outcome|Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183061|NCT02079636|OG002|Outcome|Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183062|NCT02079636|OG003|Outcome|Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183063|NCT02079636|OG000|Outcome|Part D: 100 or 150 mg Abemaciclib + 100 mg LY3023414|100 or 150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183064|NCT02079636|OG001|Outcome|Part D: 150 or 200 mg Abemaciclib + 150 mg LY3023414|150 or 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183065|NCT02079636|OG002|Outcome|Part D: 150 mg Abemaciclib + 200 mg LY3023414|150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183066|NCT02079636|OG000|Outcome|Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met
11183067|NCT02079636|OG002|Outcome|200 mg or MTD Abemaciclib + 1250 mg/m^2 Gemcitabine|200 mg abemaciclib or maximum tolerated dose (MTD) under the combination treatment abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183068|NCT02079636|OG001|Outcome|Part D: 150 or 200 mg Abemaciclib + 150 mg LY3023414|150 or 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg or 150 mg or 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183069|NCT02079636|EG000|Reported Event|Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183070|NCT02079636|EG001|Reported Event|Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183071|NCT02079636|EG002|Reported Event|Part B:150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183072|NCT02079636|EG003|Reported Event|Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183073|NCT02079636|EG004|Reported Event|Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Day1|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183074|NCT02079636|EG005|Reported Event|Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day1|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183075|NCT02079636|EG006|Reported Event|Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183076|NCT02079636|EG007|Reported Event|Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183077|NCT02079636|EG008|Reported Event|Part D: 100 mg Abemaciclib + 100 mg LY3023414|100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183078|NCT02079636|EG009|Reported Event|Part D: 150 mg Abemaciclib + 100 mg LY3023414|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183079|NCT02079636|EG010|Reported Event|Part D: 150 mg Abemaciclib + 150 mg LY3023414|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183080|NCT02079636|EG011|Reported Event|Part D: 200 mg Abemaciclib + 150 mg LY3023414|200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183081|NCT02079636|EG012|Reported Event|Part D: 150 mg Abemaciclib + 200 mg LY3023414|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183082|NCT02079636|EG013|Reported Event|Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab|100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183083|NCT02079636|EG014|Reported Event|Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab|150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11183084|NCT02079649|BG000|Baseline|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183085|NCT02079649|BG001|Baseline|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183086|NCT02079649|BG002|Baseline|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183087|NCT02079649|BG003|Baseline|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183088|NCT02079649|BG004|Baseline|Total|Total of all reporting groups
11183089|NCT02079649|FG000|Participant Flow|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183090|NCT02079649|FG001|Participant Flow|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183091|NCT02079649|FG002|Participant Flow|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183092|NCT02079649|FG003|Participant Flow|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183093|NCT02079649|OG000|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183094|NCT02079649|OG001|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183095|NCT02079649|OG002|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183096|NCT02079649|OG003|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
11183097|NCT02079649|EG000|Reported Event|Pre-Treatment|Includes all subjects who consented to participate in the study
11183098|NCT02079649|EG001|Reported Event|AL-78843|Includes all subjects who were randomized to and treated with investigational product
11183099|NCT02079649|EG002|Reported Event|AL-53817|Includes all subjects who were randomized to and treated with investigational product
11183100|NCT02079649|EG003|Reported Event|Maxidex|Includes all subjects who were randomized to and treated with investigational product
11183101|NCT02079649|EG004|Reported Event|Vehicle|Includes all subjects who were randomized to and treated with investigational product
11183102|NCT02079805|BG000|Baseline|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
11183103|NCT02079805|BG001|Baseline|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
11183104|NCT02079805|BG002|Baseline|Total|Total of all reporting groups
11183105|NCT02079805|FG000|Participant Flow|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
11183106|NCT02079805|FG001|Participant Flow|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
11183107|NCT02079805|OG000|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
11183108|NCT02079805|OG001|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
11183109|NCT02079805|EG000|Reported Event|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
11183110|NCT02079805|EG001|Reported Event|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
11183111|NCT02079844|BG000|Baseline|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183112|NCT02079844|BG001|Baseline|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183113|NCT02079844|BG002|Baseline|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183114|NCT02079844|BG003|Baseline|Total|Total of all reporting groups
11183115|NCT02079844|FG000|Participant Flow|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183116|NCT02079844|FG001|Participant Flow|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183117|NCT02079844|FG002|Participant Flow|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11235397|NCT02442869|OG002|Outcome|Stage 2 CAMS (Didn't Respond to Stage 1 TAU)|"Participant didn't respond to Stage 1 TAU and was re-randomized to:~Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"
11235398|NCT02442869|OG003|Outcome|Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)|"Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:~Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"
11235399|NCT02442869|OG004|Outcome|Stage 2 DBT (Didn't Respond to Stage 1 TAU)|"Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:~Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"
11235400|NCT02442869|OG005|Outcome|Stage 2 DBT (Didn't Respond to Stage 1 CAMS)|"Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:~Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"
11235401|NCT02442869|OG000|Outcome|Stage 1 CAMS (Participant Responding to Treatment)|"Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).~Participant responded to CAMS, treatment ended."
11235402|NCT02442869|OG001|Outcome|Stage 2 CAMS (Didn't Respond to Stage 1 TAU)|"Participant didn't respond to Stage 1 TAU and was re-randomized to:~Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"
11235403|NCT02442869|OG002|Outcome|Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)|"Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:~Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"
11235404|NCT02442869|OG000|Outcome|Stage 2 DBT (Didn't Respond to Stage 1 TAU)|"Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:~Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"
11235405|NCT02442869|OG001|Outcome|Stage 2 DBT (Didn't Respond to Stage 1 CAMS)|"Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:~Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"
11235406|NCT02442869|OG000|Outcome|Stage 1 TAU|Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.
11235407|NCT02442869|OG001|Outcome|Stage 1 CAMS|Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).
11235408|NCT02442869|EG000|Reported Event|Stage 1 TAU (Participant Responding to Treatment)|"Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.~Participant responded to TAU, treatment ended."
11235409|NCT02442869|EG001|Reported Event|Stage 1 CAMS (Participant Responding to Treatment)|"Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).~Participant responded to CAMS, treatment ended."
11235410|NCT02442869|EG002|Reported Event|Stage 2 CAMS (Didn't Respond to Stage 1 TAU)|"Participant didn't respond to Stage 1 TAU and was re-randomized to:~Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"
11235411|NCT02442869|EG003|Reported Event|Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)|"Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:~Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"
11235412|NCT02442869|EG004|Reported Event|Stage 2 DBT (Didn't Respond to Stage 1 TAU)|"Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:~Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"
11235413|NCT02442869|EG005|Reported Event|Stage 2 DBT (Didn't Respond to Stage 1 CAMS)|"Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:~Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"
11235414|NCT02443103|BG000|Baseline|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
11235415|NCT02443103|FG000|Participant Flow|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
11235416|NCT02443103|OG000|Outcome|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
11235417|NCT02443103|EG000|Reported Event|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
11235418|NCT02443155|BG000|Baseline|NNC0114-0006 + Liraglutide (Experimental)|Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235419|NCT02443155|BG001|Baseline|NNC0114-0006 (Experimental)|Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235420|NCT02443155|BG002|Baseline|Liraglutide (Experimental)|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235421|NCT02443155|BG003|Baseline|Placebo (Placebo)|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235422|NCT02443155|BG004|Baseline|Total|Total of all reporting groups
11235423|NCT02443155|FG000|Participant Flow|NNC0114-0006 + Liraglutide (Experimental)|Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11183118|NCT02079844|OG000|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183119|NCT02079844|OG001|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183120|NCT02079844|OG002|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183121|NCT02079844|OG000|Outcome|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183122|NCT02079844|OG001|Outcome|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183123|NCT02079844|OG002|Outcome|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183124|NCT02079844|EG000|Reported Event|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183125|NCT02079844|EG001|Reported Event|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183126|NCT02079844|EG002|Reported Event|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
11183127|NCT02079909|BG000|Baseline|T-817MA-H|"224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.~T-817MA-H: 224 mg or 448 mg T-817 MA once daily"
11183128|NCT02079909|BG001|Baseline|T-817MA-L|"224 mg T-817MA once daily~T-817MA-L: 224 mg T-817 MA once daily"
11183129|NCT02079909|BG002|Baseline|Placebo|"Placebo once daily~Placebo: Placebo"
11183130|NCT02079909|BG003|Baseline|Total|Total of all reporting groups
11183131|NCT02079909|FG000|Participant Flow|T-817MA-H|"224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.~T-817MA-H: 224 mg or 448 mg T-817 MA once daily"
11183132|NCT02079909|FG001|Participant Flow|T-817MA-L|"224 mg T-817MA once daily~T-817MA-L: 224 mg T-817 MA once daily"
11183133|NCT02079909|FG002|Participant Flow|Placebo|"Placebo once daily~Placebo: Placebo"
11183134|NCT02079909|OG000|Outcome|T-817MA-H|"224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.~T-817MA-H: 224 mg or 448 mg T-817 MA once daily"
11183135|NCT02079909|OG001|Outcome|T-817MA-L|"224 mg T-817MA once daily~T-817MA-L: 224 mg T-817 MA once daily"
11183136|NCT02079909|OG002|Outcome|Placebo|"Placebo once daily~Placebo: Placebo"
11183137|NCT02079909|EG000|Reported Event|T-817MA-H|"224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.~T-817MA-H: 224 mg or 448 mg T-817 MA once daily"
11183138|NCT02079909|EG001|Reported Event|T-817MA-L|"224 mg T-817MA once daily~T-817MA-L: 224 mg T-817 MA once daily"
11183139|NCT02079909|EG002|Reported Event|Placebo|"Placebo once daily~Placebo: Placebo"
11183140|NCT02079987|BG000|Baseline|ED to Home Care Transition|"The ED-to-home care transition intervention is a 4-week program that uses an Area Agency on Aging healthcare coach to conduct a home visit and at least 3 follow up phone calls to help patients develop the skills needed for disease self-management and to communicate with their providers.~ED-to-home care transition: The Area Agency on Aging coach's role is to build self-management capabilities for the patient and caregiver. During each contact, the coach reviews the 4 components of the Care Transition Intervention: 1: Follow-up Medical Visits. 2: Knowledge of disease red flags. 3: Medication reconciliation. 4: The Personal Health Record (PHR). The coach assists patients use the PHR to document and maintain vital information and to communicate with providers."
11183141|NCT02079987|BG001|Baseline|Usual Care|Usual Care: Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.
11183142|NCT02079987|BG002|Baseline|Total|Total of all reporting groups
11183143|NCT02079987|FG000|Participant Flow|ED to Home Care Transition|"The ED to home care transition intervention is a 4-week program that uses an Area Agency on Aging coach to conduct a home visit and three follow up phone calls to help patients develop self-management skills and to communicate with healthcare providers.~ED to home care transition: The Area Agency on Aging coach's role is to build self-management capabilities for the patient and caregiver. During each contact, the coach reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists the patient use the PHR to document and maintain vital information and to communicate with providers."
11183144|NCT02079987|FG001|Participant Flow|Usual Care|"Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.~Usual Care: Patients randomized to usual care will receive usual, post-ED care."
11183145|NCT02079987|OG000|Outcome|ED to Home Care Transition|"The ED to home care transition intervention is a 4-week program that uses a Area Agency on Aging coach to conduct a home visit and three follow up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers.~ED to home care transition: The Area Agency on Aging patient advocate's role is to build self-management capabilities for the patient and caregiver. During each contact, the patient advocate reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The patient advocate assists the patient use the PHR to document and maintain vital information and to communicate with providers."
11183146|NCT02079987|OG001|Outcome|Usual Care|"Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.~Usual Care: Patients randomized to usual care will receive usual, post-ED care."
11183147|NCT02079987|OG001|Outcome|Usual Care|"Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.~Usual Care: Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care."
11183148|NCT02079987|EG000|Reported Event|ED to Home Care Transition|"The ED to home care transition intervention is a 4-week program that uses an Area Agency on Aging healthcare coach to conduct a home visit and three follow up phone calls to help patients develop self-management skills and to communicate with healthcare providers.~ED to home care transition: The Area Agency on Aging coach's role is to build self-management capabilities for the patient and caregiver. During each contact, the coach reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists patient use the PHR to document and maintain vital information and to communicate with providers."
11183149|NCT02079987|EG001|Reported Event|Usual Care|"Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.~Usual Care: Patients randomized to usual care will receive usual, post-ED care."
11183150|NCT02080091|BG000|Baseline|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
11183151|NCT02080091|FG000|Participant Flow|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
11183152|NCT02080091|OG000|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
11183153|NCT02080091|EG000|Reported Event|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
11183154|NCT02080195|BG000|Baseline|Nonmyeloablative Conditioning and BMT|"Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients~Cyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors~Sodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent~Fludarabine monophosphate: Purine antimetabolite~Tacrolimus: Calcineurin inhibitor~Mofetil: Immunosuppressant~Rabbit antithymocyte globulin: Selective immunosuppressant"
11183155|NCT02080195|FG000|Participant Flow|Nonmyeloablative Conditioning and BMT|"Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients~Cyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors~Sodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent~Fludarabine monophosphate: Purine antimetabolite~Tacrolimus: Calcineurin inhibitor~Mofetil: Immunosuppressant~Rabbit antithymocyte globulin: Selective immunosuppressant"
11183156|NCT02080195|OG000|Outcome|Nonmyeloablative Conditioning and BMT|"Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients~Cyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors~Sodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent~Fludarabine monophosphate: Purine antimetabolite~Tacrolimus: Calcineurin inhibitor~Mofetil: Immunosuppressant~Rabbit antithymocyte globulin: Selective immunosuppressant"
11183157|NCT02080195|EG000|Reported Event|Nonmyeloablative Conditioning and BMT|"Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients~Cyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors~Sodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent~Fludarabine monophosphate: Purine antimetabolite~Tacrolimus: Calcineurin inhibitor~Mofetil: Immunosuppressant~Rabbit antithymocyte globulin: Selective immunosuppressant"
11183158|NCT02080221|BG000|Baseline|FOLFOXA|"1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)~FOLFOXA"
11183159|NCT02080221|FG000|Participant Flow|FOLFOXA|"1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)~FOLFOXA"
11183160|NCT02080221|OG000|Outcome|FOLFOXA|"1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)~FOLFOXA"
11183161|NCT02080221|EG000|Reported Event|FOLFOXA|"1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)~FOLFOXA"
11183162|NCT02080273|BG000|Baseline|Colgate Cavity Protection Toothpaste|"Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland~Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment."
11183163|NCT02080273|BG001|Baseline|Colgate Total Toothpaste|"Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland~Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste"
11183164|NCT02080273|BG002|Baseline|Parodontax|"Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.~Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste"
11183165|NCT02080273|BG003|Baseline|Total|Total of all reporting groups
11183166|NCT02080273|FG000|Participant Flow|Colgate Cavity Protection Toothpaste|"Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland~Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment."
11183167|NCT02080273|FG001|Participant Flow|Colgate Total Toothpaste|"Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland~Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste"
11183168|NCT02080273|FG002|Participant Flow|Parodontax|"Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.~Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste"
11183169|NCT02080273|OG000|Outcome|Colgate Cavity Protection Toothpaste|"Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland~Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment."
11183170|NCT02080273|OG001|Outcome|Colgate Total Toothpaste|"Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland~Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste"
11183171|NCT02080273|OG002|Outcome|Parodontax|"Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.~Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste"
11183172|NCT02080273|EG000|Reported Event|Colgate Cavity Protection Toothpaste|"Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland~Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment."
11183173|NCT02080273|EG001|Reported Event|Colgate Total Toothpaste|"Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland~Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste"
11183174|NCT02080273|EG002|Reported Event|Parodontax|"Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.~Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste"
11183175|NCT02080312|BG000|Baseline|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
11183176|NCT02080312|FG000|Participant Flow|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
11183177|NCT02080312|OG000|Outcome|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
11183178|NCT02080312|OG000|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
11183179|NCT02080312|EG000|Reported Event|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
11183180|NCT02080364|BG000|Baseline|A-Study: Azeliragon|Azeliragon 5 mg once daily
11183181|NCT02080364|BG001|Baseline|A-Study: Placebo|Placebo once daily
11183182|NCT02080364|BG002|Baseline|B-Study: Azeliragon|Azeliragon 5 mg once daily
11183183|NCT02080364|BG003|Baseline|B-Study: Placebo|Placebo capsule once daily
11183184|NCT02080364|BG004|Baseline|Total|Total of all reporting groups
11183185|NCT02080364|FG000|Participant Flow|A-Study: Azeliragon|Azeliragon 5 mg once daily
11183186|NCT02080364|FG001|Participant Flow|A-Study: Placebo|Placebo once daily
11183187|NCT02080364|FG002|Participant Flow|B-Study: Azeliragon|Azeliragon 5 mg once daily
11183188|NCT02080364|FG003|Participant Flow|B-Study: Placebo|Placebo capsule once daily
11183189|NCT02080364|OG000|Outcome|A-Study: Azeliragon|Azeliragon 5 mg once daily
11183190|NCT02080364|OG001|Outcome|A-Study: Placebo|Placebo once daily
11183191|NCT02080364|OG002|Outcome|B-Study: Azeliragon|Azeliragon 5 mg once daily
11183192|NCT02080364|OG003|Outcome|B-Study: Placebo|Placebo capsule once daily
11183193|NCT02080364|OG000|Outcome|Azeliragon 5mg|"Azeliragon (TTP488) 5mg orally once daily for 18 months~Azeliragon: Azeliragon 5mg administered orally, once daily for 18 months"
11183194|NCT02080364|OG001|Outcome|Placebo|"Placebo orally once daily for 18 months~Placebo: Placebo administered orally, once daily for 18 months"
11183195|NCT02080364|EG000|Reported Event|Azeliragon 5mg|"Azeliragon (TTP488) 5mg orally once daily for 18 months~Parts A and B Combined"
11183196|NCT02080364|EG001|Reported Event|Placebo|"Placebo orally once daily for 18 months~Parts A and B Combined"
11183197|NCT02080403|BG000|Baseline|Treatment|"Treatment, 2.5 mg Chlorhexidine Gluconate chip (PerioChip®) inserted every two weeks starting at Baseline for the first 3 months, plus mechanical Subgingival Debridement at Baseline and 3 months.~2.5 mg Chlorhexidine gluconate chip: Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant."
11183198|NCT02080403|BG001|Baseline|Control|Mechanical Subgingival Debridement at Baseline and 3 months.
11183199|NCT02080403|BG002|Baseline|Total|Total of all reporting groups
11183200|NCT02080403|FG000|Participant Flow|Treatment|"Treatment, 2.5 mg Chlorhexidine Gluconate chip (PerioChip®) inserted every two weeks starting at Baseline for the first 3 months, plus mechanical Subgingival Debridement at Baseline and 3 months.~2.5 mg Chlorhexidine gluconate chip: Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant."
11183201|NCT02080403|FG001|Participant Flow|Control|Mechanical Subgingival Debridement at Baseline and 3 months.
11183202|NCT02080403|OG000|Outcome|Treatment|"Treatment, 2.5 mg Chlorhexidine Gluconate chip (PerioChip®) inserted every two weeks starting at Baseline for the first 3 months, plus mechanical Subgingival Debridement at Baseline and 3 months.~2.5 mg Chlorhexidine gluconate chip: Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant."
11183203|NCT02080403|OG001|Outcome|Control|Mechanical Subgingival Debridement at Baseline and 3 months.
11183204|NCT02080403|EG000|Reported Event|Treatment|"Treatment, 2.5 mg Chlorhexidine Gluconate chip (PerioChip®) inserted every two weeks starting at Baseline for the first 3 months, plus mechanical Subgingival Debridement at Baseline and 3 months.~2.5 mg Chlorhexidine gluconate chip: Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant."
11183205|NCT02080403|EG001|Reported Event|Control|Mechanical Subgingival Debridement at Baseline and 3 months.
11183206|NCT02080455|BG000|Baseline|Lomitapide & Atorvastatin - Taken Together|"2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)~11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21)~lomitapide: 20 mg dose~Atorvastatin: 80 mg"
11183207|NCT02080455|BG001|Baseline|Lomitapide & Atorvastatin - Approx. 12 Hours Between|"2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)~11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)~lomitapide: 20 mg dose~Atorvastatin: 80 mg"
11183208|NCT02080455|BG002|Baseline|Total|Total of all reporting groups
11183209|NCT02080455|FG000|Participant Flow|Lomitapide & Atorvastatin - Taken Together|"2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)~11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21)~lomitapide: 20 mg dose~Atorvastatin: 80 mg"
11183210|NCT02080455|FG001|Participant Flow|Lomitapide & Atorvastatin - Approx. 12 Hours Between|"2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)~11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)~lomitapide: 20 mg dose~Atorvastatin: 80 mg"
11183211|NCT02080455|OG000|Outcome|PK of Lomitapide (Lomitapide Alone)|PK of lomitapide following administration of lomitapide alone
11183212|NCT02080455|OG001|Outcome|PK of Lomitapide (Coadministered Simultaneously)|PK of lomitapide following administration of lomitapide coadministered with atorvastatin simultaneously
11183213|NCT02080455|OG002|Outcome|PK of M1 (Lomitapide Alone)|PK of M1 following administration of lomitapide alone
11183214|NCT02080455|OG003|Outcome|PK of M1 (Coadministered Simultaneously)|PK of M1 following administration of lomitapide coadministered with atorvastatin simultaneously
11183215|NCT02080455|OG004|Outcome|PK of M3 (Lomitapide Alone)|PK of M3 following administration of lomitapide alone
11183216|NCT02080455|OG005|Outcome|PK of M3 (Coadministered Simultaneously)|PK of M3 following administration of lomitapide coadministered with atorvastatin simultaneously
11183217|NCT02080455|OG001|Outcome|PK of Lomitapide (Coadministered 12 Hours Apart)|PK of lomitapide following administration of lomitapide coadministered with atorvastatin 12 hours apart
11183218|NCT02080455|OG003|Outcome|PK of M1 (Coadministered 12 Hours Apart)|PK of M1 following administration of lomitapide coadministered with atorvastatin 12 hours apart
11183219|NCT02080455|OG005|Outcome|PK of M3 (Coadministered 12 Hours Apart)|PK of M3 following administration of lomitapide coadministered with atorvastatin 12 hours apart
11183220|NCT02080455|OG001|Outcome|PK of Lomitapide (Coadminister 12 Hours Apart)|PK of lomitapide following administration of lomitapide coadministered with atorvastatin 12 hours apart
11183221|NCT02080455|EG000|Reported Event|Lomitapide & Atorvastatin - Taken Together|"2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)~11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21)~lomitapide: 20 mg dose~Atorvastatin: 80 mg"
11183222|NCT02080455|EG001|Reported Event|Lomitapide & Atorvastatin - Approx. 12 Hours Between|"2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)~11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)~lomitapide: 20 mg dose~Atorvastatin: 80 mg"
11183223|NCT02080468|BG000|Baseline|Lomitapide & EE/Norgestimate - Taken Together|"2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)~21 single oral doses of EE/Norgestimate(Day 8 through day 28)~lomitapide: 20 mg~EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet"
11183224|NCT02080468|BG001|Baseline|Lomitapide & EE/Norgestimate - Taken 12 Hours Apart|"2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)~21 single oral doses of EE/Norgestimate(Day 9 through day 29)~lomitapide: 20 mg~EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet"
11183225|NCT02080468|BG002|Baseline|Total|Total of all reporting groups
11183226|NCT02080468|FG000|Participant Flow|Lomitapide & EE/Norgestimate - Taken Together|"2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)~21 single oral doses of EE/Norgestimate(Day 8 through day 28)~lomitapide: 20 mg~EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet"
11183227|NCT02080468|FG001|Participant Flow|Lomitapide & EE/Norgestimate - Taken 12 Hours Apart|"2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)~21 single oral doses of EE/Norgestimate(Day 9 through day 29)~lomitapide: 20 mg~EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet"
11183228|NCT02080468|OG000|Outcome|PK of Lomitapide (Lomitapide Alone)|PK of lomitapide following administration of lomitapide alone
11183229|NCT02080468|OG001|Outcome|PK of Lomitapide (Coadministered Simultaneously)|PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously
11183230|NCT02080468|OG002|Outcome|PK of M1 (Lomitapide Alone)|PK of M1 following administration of lomitapide alone
11183231|NCT02080468|OG003|Outcome|PK of M1 (Coadministered Simultaneously)|PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
11183232|NCT02080468|OG004|Outcome|PK of M3 (Lomitapide Alone)|PK of M3 following administration of lomitapide alone
11183233|NCT02080468|OG005|Outcome|PK of M3 (Coadministered Simultaneously)|PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
11183234|NCT02080468|OG001|Outcome|PK of Lomitapide (Codministered 12 Hours Apart)|PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
11183235|NCT02080468|OG003|Outcome|PK of M1 (Coadministered 12 Hours Apart)|PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
11183236|NCT02080468|OG005|Outcome|PK of M3 (Coadministered 12 Hours Apart)|PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart
11183237|NCT02080468|EG000|Reported Event|Lomitapide & EE/Norgestimate - Taken Together|"2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)~21 single oral doses of EE/Norgestimate(Day 8 through day 28)~lomitapide: 20 mg~EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet"
11183238|NCT02080468|EG001|Reported Event|Lomitapide & EE/Norgestimate - Taken 12 Hours Apart|"2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22)~21 single oral doses of EE/Norgestimate(Day 9 through day 29)~lomitapide: 20 mg~EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet"
11183239|NCT02080481|BG000|Baseline|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
11183240|NCT02080481|BG001|Baseline|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
11183241|NCT02080481|BG002|Baseline|Total|Total of all reporting groups
11183242|NCT02080481|FG000|Participant Flow|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
11183243|NCT02080481|FG001|Participant Flow|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
11183244|NCT02080481|OG000|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
11183245|NCT02080481|OG001|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
11183246|NCT02080481|EG000|Reported Event|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
11183247|NCT02080481|EG001|Reported Event|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
11183248|NCT02080507|BG000|Baseline|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
11183249|NCT02080507|BG001|Baseline|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
11183250|NCT02080507|BG002|Baseline|Total|Total of all reporting groups
11183251|NCT02080507|FG000|Participant Flow|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
11183252|NCT02080507|FG001|Participant Flow|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
11183253|NCT02080507|OG000|Outcome|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
11183254|NCT02080507|OG001|Outcome|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
11183255|NCT02080507|EG000|Reported Event|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
11183256|NCT02080507|EG001|Reported Event|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
11183257|NCT02080546|BG000|Baseline|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
11183258|NCT02080546|BG001|Baseline|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
11183259|NCT02080546|BG002|Baseline|Total|Total of all reporting groups
11183260|NCT02080546|FG000|Participant Flow|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
11183261|NCT02080546|FG001|Participant Flow|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
11183262|NCT02080546|OG000|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
11183263|NCT02080546|OG001|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
11183264|NCT02080546|EG000|Reported Event|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
11183265|NCT02080546|EG001|Reported Event|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
11183266|NCT02080637|BG000|Baseline|Ambrisentan|"Oral ambrisentan 2.5 - 5 mg, single dose, once daily~Ambrisentan: Once daily oral dosing"
11183267|NCT02080637|BG001|Baseline|Placebo|"Oral placebo 2.5 - 5 mg, single dose, once daily~Placebo"
11183268|NCT02080637|BG002|Baseline|Total|Total of all reporting groups
11183269|NCT02080637|FG000|Participant Flow|Ambrisentan|"Oral ambrisentan 2.5 - 5 mg, single dose, once daily~Ambrisentan: Once daily oral dosing"
11183270|NCT02080637|FG001|Participant Flow|Placebo|"Oral placebo 2.5 - 5 mg, single dose, once daily~Placebo"
11183271|NCT02080637|OG000|Outcome|Ambrisentan|"Oral ambrisentan 2.5 - 5 mg, single dose, once daily~Ambrisentan: Once daily oral dosing"
11183272|NCT02080637|OG001|Outcome|Placebo|"Oral placebo 2.5 - 5 mg, single dose, once daily~Placebo"
11183273|NCT02080637|EG000|Reported Event|Ambrisentan|"Oral ambrisentan 2.5 - 5 mg, single dose, once daily~Ambrisentan: Once daily oral dosing"
11183274|NCT02080637|EG001|Reported Event|Placebo|"Oral placebo 2.5 - 5 mg, single dose, once daily~Placebo"
11183275|NCT02080780|BG000|Baseline|2% Diltiazem & Clarithromycin XL|"3 parts:~- Diltiazem Single Dose~- Clarithromycin XL (Days 4-9)~- Diltiazem Single Dose after Clarithromycin~Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg~2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
11183276|NCT02080780|FG000|Participant Flow|2% Diltiazem & Clarithromycin XL|"3 parts:~- Diltiazem Single Dose~- Clarithromycin XL (Days 4-9)~- Diltiazem Single Dose after Clarithromycin~Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg~2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
11183277|NCT02080780|OG000|Outcome|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
11183278|NCT02080780|OG001|Outcome|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
11183279|NCT02080780|EG000|Reported Event|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
11183280|NCT02080780|EG001|Reported Event|Clarithromycin XL (Days 4-9)|On Days 4 through 9, subjects received once daily doses of clarithromycin XL (2 tablets, 500 mg/tablet, total dose = 1000 mg/day; 6000 mg total in 6 days) with 24 hours between doses.
11183281|NCT02080780|EG002|Reported Event|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
11183282|NCT02080819|BG000|Baseline|Healthy Control|Non drug using healthy controls
11191410|NCT02132468|EG000|Reported Event|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
11183283|NCT02080819|BG001|Baseline|Placebo|"Placebo BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
11183284|NCT02080819|BG002|Baseline|Medication|"Levodopa/carbidopa 400/100 BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
11183285|NCT02080819|BG003|Baseline|Total|Total of all reporting groups
11183286|NCT02080819|FG000|Participant Flow|Healthy Control|Non drug using healthy controls
11183287|NCT02080819|FG001|Participant Flow|Placebo|"Placebo BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
11183288|NCT02080819|FG002|Participant Flow|Medication|"Levodopa/carbidopa 400/100 BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
11183289|NCT02080819|OG000|Outcome|Healthy Control|Non drug using healthy controls
11183290|NCT02080819|OG001|Outcome|Placebo|"Placebo BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
11183291|NCT02080819|OG002|Outcome|Medication|"Levodopa/carbidopa 400/100 BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
11183292|NCT02080819|EG000|Reported Event|Healthy Control|Non drug using healthy controls
11183293|NCT02080819|EG001|Reported Event|Placebo|"Placebo BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
11183294|NCT02080819|EG002|Reported Event|Medication|"Levodopa/carbidopa 400/100 BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
11183295|NCT02080832|BG000|Baseline|Medication Citalopram 20mg|"Citalopram (20mg dose)~Citalopram: 20 mg daily for 8 weeks"
11183296|NCT02080832|BG001|Baseline|Placebo|Placebo: Placebo daily for 8 weeks
11183297|NCT02080832|BG002|Baseline|Medication Citalopram 40mg|Citalopram (40mg dose) 40mg daily for 8 weeks
11183298|NCT02080832|BG003|Baseline|Total|Total of all reporting groups
11183299|NCT02080832|FG000|Participant Flow|Medication Citalopram (20mg Dose)|"Citalopram (20mg dose)~Citalopram: 20 mg daily for 8 weeks"
11183300|NCT02080832|FG001|Participant Flow|Placebo|Placebo: Placebo daily for 8 weeks
11183301|NCT02080832|FG002|Participant Flow|Medication Citalopram (40mg Dose)|Citalopram (40mg dose) 40mg daily for 8 weeks
11183302|NCT02080832|OG000|Outcome|Medication (Citalopram 20mg)|"Citalopram (20mg dose)~Citalopram: 20 mg or 40 mg daily for 8 weeks"
11183303|NCT02080832|OG001|Outcome|Placebo|Placebo: Placebo daily for 8 weeks
11183304|NCT02080832|OG002|Outcome|Medication (Citalopram 40mg)|"Citalopram 40mg dose~Citalopram: 20 mg or 40 mg daily for 8 weeks"
11183305|NCT02080832|OG000|Outcome|Citalopram (20mg or 40mg)|Participants treated with citalopram, either 20mg or 40mg
11183306|NCT02080832|OG001|Outcome|Placebo|
11183307|NCT02080832|EG000|Reported Event|Medication (Citalopram 20mg)|"Citalopram (20mg dose)~Citalopram: 20 mg or 40 mg daily for 8 weeks"
11183308|NCT02080832|EG001|Reported Event|Placebo|Placebo: Placebo daily for 8 weeks
11183309|NCT02080832|EG002|Reported Event|Medication (Citalopram 40mg)|"Citalopram 40mg dose~Citalopram: 20 mg or 40 mg daily for 8 weeks"
11183310|NCT02080871|BG000|Baseline|Iliac Stenting|"Balloon expandable stenting of iliac occlusive disease~Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease."
11183311|NCT02080871|FG000|Participant Flow|Gore VIABAHN BX|"Balloon expandable stenting of iliac occlusive disease~Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease."
11183312|NCT02080871|OG000|Outcome|Iliac Stenting|"Balloon expandable stenting of iliac occlusive disease~Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease."
11183313|NCT02080871|EG000|Reported Event|Iliac Stenting|"Balloon expandable stenting of iliac occlusive disease~Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease."
11183314|NCT02081001|BG000|Baseline|Xeris G-Pump Glucagon First, Followed by GlucaGen|Subjects who received G-Pump (glucagon infusion) at the first treatment visit and GlucaGen at the second treatment visit.
11183315|NCT02081001|BG001|Baseline|GlucaGen First, Followed by Xeris G-Pump|Subjects who received GlucaGen at the first treatment visit and G-Pump (glucagon infusion) at the second treatment visit.
11183316|NCT02081001|BG002|Baseline|Total|Total of all reporting groups
11183317|NCT02081001|FG000|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
11183318|NCT02081001|FG001|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
11183319|NCT02081001|FG002|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
11183320|NCT02081001|FG003|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
11183321|NCT02081001|FG004|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
11183322|NCT02081001|FG005|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
11183323|NCT02081001|FG006|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
11183324|NCT02081001|FG007|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
11183325|NCT02081001|FG008|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
11183326|NCT02081001|FG009|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
11183327|NCT02081001|FG010|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
11183328|NCT02081001|FG011|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
11183329|NCT02081001|OG000|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
11183330|NCT02081001|OG001|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
11183331|NCT02081001|OG002|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
11183332|NCT02081001|OG003|Outcome|0.3μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
11183333|NCT02081001|OG004|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
11191411|NCT02132520|BG000|Baseline|Control|Subjects receiving standard-of-care physical therapy only.
11183334|NCT02081001|OG005|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
11183335|NCT02081001|OG003|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
11183336|NCT02081001|EG000|Reported Event|G-Pump™ (Glucagon Infusion)|G-Pump™ (glucagon infusion); single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg delivered via infusion pump
11183337|NCT02081001|EG001|Reported Event|Novo Nordisk GlucaGen®|Novo Nordisk GlucaGen®; single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg delivered by infusion pump
11183338|NCT02081014|BG000|Baseline|Total Study Group|Includes all 12 treated subjects
11183339|NCT02081014|FG000|Participant Flow|G-Pen Mini™ Dose Order: 75, 150 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 75 microgram (ug) subcutaneous (SC) injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
11183340|NCT02081014|FG001|Participant Flow|G-Pen Mini™ Dose Order: 75, 300 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 75 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
11183341|NCT02081014|FG002|Participant Flow|G-Pen Mini™ Dose Order: 150, 75 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
11183342|NCT02081014|FG003|Participant Flow|G-Pen Mini™ Dose Order: 150, 300 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
11183343|NCT02081014|FG004|Participant Flow|G-Pen Mini™ Dose Order: 300, 75 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
11183344|NCT02081014|FG005|Participant Flow|G-Pen Mini™ Dose Order: 300, 150 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 75 ug SC injections at treatment visit 3.
11183345|NCT02081014|OG000|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
11183346|NCT02081014|OG001|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
11183347|NCT02081014|OG002|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
11183348|NCT02081014|OG000|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
11183349|NCT02081014|OG001|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
11183350|NCT02081014|OG002|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
11183351|NCT02081014|OG000|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
11183352|NCT02081014|OG001|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
11183353|NCT02081014|OG002|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
11183354|NCT02081014|OG000|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
11183355|NCT02081014|OG001|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
11183356|NCT02081014|OG002|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
11183357|NCT02081014|EG000|Reported Event|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
11183358|NCT02081014|EG001|Reported Event|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
11183359|NCT02081014|EG002|Reported Event|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
11183360|NCT02081079|BG000|Baseline|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
11183361|NCT02081079|BG001|Baseline|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
11183362|NCT02081079|BG002|Baseline|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
11183363|NCT02081079|BG003|Baseline|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
11183364|NCT02081079|BG004|Baseline|Total|Total of all reporting groups
11183365|NCT02081079|FG000|Participant Flow|Genotype 4|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily for up to 12 weeks in participants with genotype 4 hepatitis C virus (HCV) infection
11183366|NCT02081079|FG001|Participant Flow|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
11183367|NCT02081079|OG000|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
11183368|NCT02081079|OG001|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
11183369|NCT02081079|OG002|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
11183370|NCT02081079|OG003|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
11183371|NCT02081079|OG000|Outcome|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
11183372|NCT02081079|OG001|Outcome|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
11183373|NCT02081079|EG000|Reported Event|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
11183374|NCT02081079|EG001|Reported Event|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
11183375|NCT02081196|BG000|Baseline|CoolSculpting Intervention|CoolSculpting treatments were performed on one (1) flank in a single treatment visit.
11183376|NCT02081196|FG000|Participant Flow|CoolSculpting Intervention|CoolSculpting treatments were performed on one (1) flank in a single treatment visit. The contralateral flank served as the untreated control.
11183377|NCT02081196|OG000|Outcome|CoolSculpting of the Flank With Alternate Treatment Parameters|"Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.~Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration using the Zeltiq CoolSculpting System."
11183378|NCT02081196|EG000|Reported Event|CoolSculpting of the Flank -Subjects With Systemic AEs|Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
11183379|NCT02081196|EG001|Reported Event|Flank Treated With CoolSculpting Group|One flank on each enrolled subject was treated with CoolSculpting.
11183380|NCT02081196|EG002|Reported Event|UnTreated Contralateral Flank|Each enrolled subject had one flank that was untreated, and no intervention was used.
11183381|NCT02081248|BG000|Baseline|Standard Consent|"This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.~Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials."
11183382|NCT02081248|BG001|Baseline|Easy-to-Read Informed Consent|"This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.~Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language."
11183383|NCT02081248|BG002|Baseline|Total|Total of all reporting groups
11183384|NCT02081248|FG000|Participant Flow|Standard Consent|"This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.~Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials."
11183385|NCT02081248|FG001|Participant Flow|Easy-to-Read Informed Consent|"This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.~Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language."
11183386|NCT02081248|OG000|Outcome|Standard Consent|"This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.~Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials."
11183387|NCT02081248|OG001|Outcome|Easy-to-Read Informed Consent|"This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.~Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language."
11183388|NCT02081248|EG000|Reported Event|Standard Consent|"This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.~Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials."
11191412|NCT02132520|BG001|Baseline|Sham rTMS + Real BCI Training|"Subjects will receive sham rTMS followed by real BCI training.~rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.~BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen."
11183389|NCT02081248|EG001|Reported Event|Easy-to-Read Informed Consent|"This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.~Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language."
11183390|NCT02081365|BG000|Baseline|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
11183391|NCT02081365|BG001|Baseline|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
11183392|NCT02081365|BG002|Baseline|Total|Total of all reporting groups
11183393|NCT02081365|FG000|Participant Flow|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
11183394|NCT02081365|FG001|Participant Flow|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
11183395|NCT02081365|OG000|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
11183396|NCT02081365|OG001|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
11183397|NCT02081365|EG000|Reported Event|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
11183398|NCT02081365|EG001|Reported Event|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
11183399|NCT02081417|BG000|Baseline|Peer Led|"Number of sessions of the intervention of an evidenced based practice called Seeking Safety led by a Peer (6 sessions will be used to define treatment completion)~Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs."
11183400|NCT02081417|BG001|Baseline|Clinician Led|"Number of intervention groups of an evidence based practice called Seeking Safety led by a master's level Clinician (6 sessions will be used to define treatment completion).~Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs."
11183401|NCT02081417|BG002|Baseline|Total|Total of all reporting groups
11183402|NCT02081417|FG000|Participant Flow|Peer Led|"number of sessions of the intervention of an evidenced based practice called Seeking Safety led by a Peer (6 sessions will be used to define treatment completion)~Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs."
11183403|NCT02081417|FG001|Participant Flow|Clinician Led|"number of intervention groups of an evidence based practice called Seeking Safety led by a master's level Clinician (6 sessions will be used to define treatment completion).~Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs."
11183404|NCT02081417|OG000|Outcome|Peer Led|"Seeking Safety Intervention Led by the Peer Providers~Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs."
11183405|NCT02081417|OG001|Outcome|Clinician Led|"Seeking Safety Intervention Led by the Clinicians~Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs."
11183406|NCT02081417|EG000|Reported Event|Peer Led|"## sessions of the intervention of an evidenced based practice called Seeking Safety led by a Peer (6 sessions will be used to define treatment completion)~Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs."
11183407|NCT02081417|EG001|Reported Event|Clinician Led|"# intervention groups of an evidence based practice called Seeking Safety led by a master's level Clinician (6 sessions will be used to define treatment completion).~Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs."
11183408|NCT02081443|BG000|Baseline|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
11183409|NCT02081443|BG001|Baseline|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
11183410|NCT02081443|BG002|Baseline|Total|Total of all reporting groups
11183411|NCT02081443|FG000|Participant Flow|Ticagrelor 180mg|The proposed study have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays was done following in vitro incubation with and without 500 nM cangrelor.
11183412|NCT02081443|FG001|Participant Flow|Ticagrelor 90mg|The proposed study has a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays were done following in vitro incubation with and without 500 nM cangrelor.
11183413|NCT02081443|OG000|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
11183414|NCT02081443|OG001|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
11183415|NCT02081443|EG000|Reported Event|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
11183416|NCT02081443|EG001|Reported Event|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
11183417|NCT02081456|BG000|Baseline|Therapeutic Ultrasound|"Therapeutic ultrasound applied for a period of 5 minutes to the most painful region of the neck, then a second 5 minute dose at the most painful region of the upper extremity~Therapeutic Ultrasound"
11183418|NCT02081456|BG001|Baseline|Soft Tissue Mobilization|"Passive soft tissue mobilization to the neck and upper extremity~Soft Tissue Mobilization"
11183419|NCT02081456|BG002|Baseline|Total|Total of all reporting groups
11183420|NCT02081456|FG000|Participant Flow|Therapeutic Ultrasound|"Therapeutic ultrasound applied for a period of 5 minutes to the most painful region of the neck, then a second 5 minute dose at the most painful region of the upper extremity~Therapeutic Ultrasound"
11183421|NCT02081456|FG001|Participant Flow|Soft Tissue Mobilization|"Passive soft tissue mobilization to the neck and upper extremity~Soft Tissue Mobilization"
11183422|NCT02081456|OG000|Outcome|Therapeutic Ultrasound|"Therapeutic ultrasound applied for a period of 5 minutes to the most painful region of the neck, then a second 5 minute dose at the most painful region of the upper extremity~Therapeutic Ultrasound"
11183423|NCT02081456|OG001|Outcome|Soft Tissue Mobilization|"Passive soft tissue mobilization to the neck and upper extremity~Soft Tissue Mobilization"
11183424|NCT02081456|EG000|Reported Event|Therapeutic Ultrasound|"Therapeutic ultrasound applied for a period of 5 minutes to the most painful region of the neck, then a second 5 minute dose at the most painful region of the upper extremity~Therapeutic Ultrasound"
11183425|NCT02081456|EG001|Reported Event|Soft Tissue Mobilization|"Passive soft tissue mobilization to the neck and upper extremity~Soft Tissue Mobilization"
11183426|NCT02081534|BG000|Baseline|1 mg Bid|"1 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183427|NCT02081534|BG001|Baseline|3 mg Bid|"3 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183428|NCT02081534|BG002|Baseline|10 mg Bid|"10 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183429|NCT02081534|BG003|Baseline|30 mg Bid|"30 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183430|NCT02081534|BG004|Baseline|3 mg od|"3 mg AZD1722 od~AZD1722: tenapanor, oral tablet"
11183431|NCT02081534|BG005|Baseline|30 mg od|"30 mg AZD1722 od~AZD1722: tenapanor, oral tablet"
11183432|NCT02081534|BG006|Baseline|Placebo|"Placebo (double dummy technique)~Placebo: Placebo bid, double dummy technique"
11183433|NCT02081534|BG007|Baseline|Total|Total of all reporting groups
11183434|NCT02081534|FG000|Participant Flow|1 mg Bid|"1 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183435|NCT02081534|FG001|Participant Flow|3 mg Bid|"3 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183436|NCT02081534|FG002|Participant Flow|10 mg Bid|"10 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183437|NCT02081534|FG003|Participant Flow|30 mg Bid|"30 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183438|NCT02081534|FG004|Participant Flow|3 mg od|"3 mg AZD1722 od~AZD1722: tenapanor, oral tablet"
11183439|NCT02081534|FG005|Participant Flow|30 mg od|"30 mg AZD1722 od~AZD1722: tenapanor, oral tablet"
11183440|NCT02081534|FG006|Participant Flow|Placebo|"Placebo (double dummy technique)~Placebo: Placebo bid, double dummy technique"
11183441|NCT02081534|OG000|Outcome|1 mg Bid|"1 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183442|NCT02081534|OG001|Outcome|3 mg Bid|"3 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183443|NCT02081534|OG002|Outcome|10 mg Bid|"10 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183444|NCT02081534|OG003|Outcome|30 mg Bid|"30 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183445|NCT02081534|OG004|Outcome|3 mg od|"3 mg AZD1722 od~AZD1722: tenapanor, oral tablet"
11183446|NCT02081534|OG005|Outcome|30 mg od|"30 mg AZD1722 od~AZD1722: tenapanor, oral tablet"
11183447|NCT02081534|OG006|Outcome|Placebo|"Placebo (double dummy technique)~Placebo: Placebo bid, double dummy technique"
11183448|NCT02081534|EG000|Reported Event|1 mg Bid|"1 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183449|NCT02081534|EG001|Reported Event|3 mg Bid|"3 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183450|NCT02081534|EG002|Reported Event|10 mg Bid|"10 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183451|NCT02081534|EG003|Reported Event|30 mg Bid|"30 mg AZD1722 bid~AZD1722: tenapanor, oral tablet"
11183452|NCT02081534|EG004|Reported Event|3 mg od|"3 mg AZD1722 od~AZD1722: tenapanor, oral tablet"
11183453|NCT02081534|EG005|Reported Event|30 mg od|"30 mg AZD1722 od~AZD1722: tenapanor, oral tablet"
11183454|NCT02081534|EG006|Reported Event|Placebo|"Placebo (double dummy technique)~Placebo: Placebo bid, double dummy technique"
11183455|NCT02081573|BG000|Baseline|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
11183456|NCT02081573|FG000|Participant Flow|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
11183457|NCT02081573|OG000|Outcome|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
11183458|NCT02081573|EG000|Reported Event|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
11183459|NCT02081586|BG000|Baseline|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183460|NCT02081586|BG001|Baseline|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183461|NCT02081586|BG002|Baseline|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183462|NCT02081586|BG003|Baseline|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183463|NCT02081586|BG004|Baseline|Total|Total of all reporting groups
11183464|NCT02081586|FG000|Participant Flow|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183465|NCT02081586|FG001|Participant Flow|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11341796|NCT03688620|BG002|Baseline|Vaccinated_Fluarix Tetra Group|"Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between~01 October and 31 December 2018."
11341797|NCT03688620|BG003|Baseline|Total|Total of all reporting groups
11183466|NCT02081586|FG002|Participant Flow|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183467|NCT02081586|FG003|Participant Flow|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183468|NCT02081586|OG000|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183469|NCT02081586|OG001|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183470|NCT02081586|OG002|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183471|NCT02081586|OG003|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183472|NCT02081586|OG004|Outcome|Participants Administered Phone CBT|This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
11183473|NCT02081586|OG003|Outcome|Standard Diabetes Care at PCP|"Patients will remain in usual care and not receive study intervention. This will include usual diabetes care at PCP.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183474|NCT02081586|EG000|Reported Event|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183475|NCT02081586|EG001|Reported Event|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183476|NCT02081586|EG002|Reported Event|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183477|NCT02081586|EG003|Reported Event|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
11183478|NCT02081599|BG000|Baseline|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
11183479|NCT02081599|BG001|Baseline|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
11183480|NCT02081599|BG002|Baseline|Total|Total of all reporting groups
11183481|NCT02081599|FG000|Participant Flow|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
11183482|NCT02081599|FG001|Participant Flow|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
11183483|NCT02081599|OG000|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
11183484|NCT02081599|OG001|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
11183485|NCT02081599|EG000|Reported Event|Placebo/Teneli (Teneligliptin) + Insulin(Data Through Week 16)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
11183486|NCT02081599|EG001|Reported Event|Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
11183487|NCT02081599|EG002|Reported Event|Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 16 to Week 52 were shown.
11183488|NCT02081599|EG003|Reported Event|Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 52 were shown.
11183489|NCT02081638|BG000|Baseline|Daily Aspirin|"HIV Infected on ART~Elite controllers not on ART"
11183490|NCT02081638|BG001|Baseline|Daily Atorvastatin|"HIV Infected on ART~Elite controllers not on ART"
11183491|NCT02081638|BG002|Baseline|Total|Total of all reporting groups
11183492|NCT02081638|FG000|Participant Flow|Daily Aspirin|"HIV Infected on ART~HIV Infected off ART"
11183493|NCT02081638|FG001|Participant Flow|Daily Lipitor|"HIV Infected on ART~HIV infected off ART"
11183494|NCT02081638|OG000|Outcome|Daily Aspirin|"HIV Infected on ART~Elite controllers not on ART"
11183495|NCT02081638|OG001|Outcome|Daily Atorvastatin|"HIV Infected on ART~Elite controllers not on ART"
11183496|NCT02081638|OG000|Outcome|Daily Aspirin on ART|Treated Individuals on Chronic Antiretroviral Therapy
11183497|NCT02081638|OG001|Outcome|Daily Aspirin Not on ART|Elite controllers not on Chronic Antiretroviral Therapy
11183498|NCT02081638|OG002|Outcome|Daily Atorvastatin on ART|Treated Individuals on Chronic Antiretroviral Therapy
11183499|NCT02081638|OG003|Outcome|Daily Atorvastatin Not on ART|Elite controllers not on Chronic Antiretroviral Therapy
11183500|NCT02081638|EG000|Reported Event|Daily Aspirin|"HIV Infected on ART~Elite controllers not on Chronic Antiretroviral Therapy"
11183501|NCT02081638|EG001|Reported Event|Daily Atorvastatin|"HIV Infected on ART~Elite controllers not on Chronic Antiretroviral Therapy"
11183502|NCT02081677|BG000|Baseline|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
11183503|NCT02081677|BG001|Baseline|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
11183504|NCT02081677|BG002|Baseline|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
11183505|NCT02081677|BG003|Baseline|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
11183506|NCT02081677|BG004|Baseline|Total|Total of all reporting groups
11183507|NCT02081677|FG000|Participant Flow|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
11183508|NCT02081677|FG001|Participant Flow|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
11183509|NCT02081677|FG002|Participant Flow|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
11183510|NCT02081677|FG003|Participant Flow|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
11183511|NCT02081677|OG000|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
11183512|NCT02081677|OG001|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
11183513|NCT02081677|OG002|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
11183514|NCT02081677|OG003|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
11183515|NCT02081677|EG000|Reported Event|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
11183516|NCT02081677|EG001|Reported Event|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
11183517|NCT02081677|EG002|Reported Event|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
11183518|NCT02081677|EG003|Reported Event|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
11183519|NCT02081690|BG000|Baseline|Macitentan|Macitentan tablet, dose of 10 mg, once daily
11235424|NCT02443155|FG001|Participant Flow|NNC0114-0006 (Experimental)|Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235425|NCT02443155|FG002|Participant Flow|Liraglutide (Experimental)|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235426|NCT02443155|FG003|Participant Flow|Placebo (Placebo)|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235427|NCT02443155|OG000|Outcome|NNC0114-0006 + Liraglutide (Experimental)|Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235428|NCT02443155|OG001|Outcome|NNC0114-0006 (Experimental)|Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235429|NCT02443155|OG002|Outcome|Liraglutide (Experimental)|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235430|NCT02443155|OG003|Outcome|Placebo (Placebo)|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235431|NCT02443155|OG001|Outcome|Liraglutide (Experimental)|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235432|NCT02443155|EG000|Reported Event|NNC0114-0006 + Liraglutide|Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235433|NCT02443155|EG001|Reported Event|NNC0114-0006|Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235434|NCT02443155|EG002|Reported Event|Liraglutide|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235435|NCT02443155|EG003|Reported Event|Placebo|Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
11235436|NCT02443298|BG000|Baseline|Risankizumab|Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20)
11183520|NCT02081690|FG000|Participant Flow|Macitentan|Subjects received Macitentan at a 10 mg oral dose, once daily during 16 weeks
11183521|NCT02081690|OG000|Outcome|Macitentan|Macitentan tablet, dose of 10 mg, once daily
11183522|NCT02081690|EG000|Reported Event|Macitentan|Macitentan tablet, dose of 10 mg, once daily
11183523|NCT02081807|BG000|Baseline|Optum Clinformatics - Dabigatran|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183524|NCT02081807|BG001|Baseline|Optum Clinformatics - Warfarin|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183525|NCT02081807|BG002|Baseline|Optum Clinformatics - Rivaroxaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183526|NCT02081807|BG003|Baseline|Optum Clinformatics - Apixaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183527|NCT02081807|BG004|Baseline|MarketScan - Dabigatran|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183528|NCT02081807|BG005|Baseline|MarketScan - Warfarin|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183529|NCT02081807|BG006|Baseline|MarketScan - Rivaroxaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183530|NCT02081807|BG007|Baseline|MarketScan - Apixaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183531|NCT02081807|BG008|Baseline|Total|Total of all reporting groups
11183532|NCT02081807|FG000|Participant Flow|Optum Clinformatics - Dabigatran|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183533|NCT02081807|FG001|Participant Flow|Optum Clinformatics - Warfarin|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183534|NCT02081807|FG002|Participant Flow|Optum Clinformatics - Rivaroxaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183535|NCT02081807|FG003|Participant Flow|Optum Clinformatics - Apixaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183536|NCT02081807|FG004|Participant Flow|MarketScan - Dabigatran|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183537|NCT02081807|FG005|Participant Flow|MarketScan - Warfarin|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183538|NCT02081807|FG006|Participant Flow|MarketScan - Rivaroxaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183539|NCT02081807|FG007|Participant Flow|MarketScan - Apixaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183540|NCT02081807|OG000|Outcome|Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with warfarin
11183541|NCT02081807|OG001|Outcome|Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with dabigatran
11183542|NCT02081807|OG002|Outcome|MarketScan - Dabigatran vs. Warfarin (Dabigatran)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with warfarin
11183543|NCT02081807|OG003|Outcome|MarketScan - Dabigatran vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with dabigatran
11183544|NCT02081807|OG004|Outcome|Optum Clinformatics - Rivaroxaban vs. Warfarin (Rivaroxaban)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with warfarin
11235437|NCT02443298|BG001|Baseline|Placebo|Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20)
11183545|NCT02081807|OG005|Outcome|Optum Clinformatics - Rivaroxaban vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with rivaroxaban
11183546|NCT02081807|OG006|Outcome|MarketScan - Rivaroxaban vs. Warfarin (Rivaroxaban)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with warfarin
11183547|NCT02081807|OG007|Outcome|MarketScan - Rivaroxaban vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with rivaroxaban
11183548|NCT02081807|OG008|Outcome|Optum Clinformatics - Apixaban vs. Warfarin (Apixaban)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with warfarin
11183549|NCT02081807|OG009|Outcome|Optum Clinformatics - Apixaban vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with apixaban
11183550|NCT02081807|OG010|Outcome|MarketScan - Apixaban vs. Warfarin (Apixaban)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with warfarin
11183551|NCT02081807|OG011|Outcome|MarketScan - Apixaban vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with apixaban
11183552|NCT02081807|OG000|Outcome|Dabigatran vs. Warfarin (Dabigatran)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores with warfarin
11183553|NCT02081807|OG001|Outcome|Dabigatran vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores with dabigatran
11183554|NCT02081807|OG002|Outcome|Rivaroxaban vs. Warfarin (Rivaroxaban)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores with warfarin
11183555|NCT02081807|OG003|Outcome|Rivaroxaban vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores with rivaroxaban
11183556|NCT02081807|OG004|Outcome|Apixaban vs. Warfarin (Apixaban)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores with warfarin
11183557|NCT02081807|OG005|Outcome|Apixaban vs. Warfarin (Warfarin)|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores with apixaban
11183558|NCT02081807|EG000|Reported Event|Optum Clinformatics - Dabigatran|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183559|NCT02081807|EG001|Reported Event|Optum Clinformatics - Warfarin|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183560|NCT02081807|EG002|Reported Event|Optum Clinformatics - Rivaroxaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183561|NCT02081807|EG003|Reported Event|Optum Clinformatics - Apixaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation
11183562|NCT02081807|EG004|Reported Event|MarketScan - Dabigatran|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183563|NCT02081807|EG005|Reported Event|MarketScan - Warfarin|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183564|NCT02081807|EG006|Reported Event|MarketScan - Rivaroxaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11235438|NCT02443298|BG002|Baseline|Total|Total of all reporting groups
11183565|NCT02081807|EG007|Reported Event|MarketScan - Apixaban|Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation
11183566|NCT02081846|BG000|Baseline|Home Nurse Visit|"Families in this arm will receive a nurse home visit within 96 hours of discharge.~Nurse Home Visit: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a nurse home visit program, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants) and re-engineered through Aim 2, in improving pediatric patient transitions from hospital to home"
11183567|NCT02081846|BG001|Baseline|Control|"This arm will receive standard of care.~Standard of Care: Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside."
11183568|NCT02081846|BG002|Baseline|Total|Total of all reporting groups
11183569|NCT02081846|FG000|Participant Flow|Home Nurse Visit|"Families in this arm will receive a nurse home visit within 96 hours of discharge.~Nurse Home Visit: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a nurse home visit program, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants) and re-engineered through Aim 2, in improving pediatric patient transitions from hospital to home"
11183570|NCT02081846|FG001|Participant Flow|Control|"This arm will receive standard of care.~Standard of Care: Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside."
11183571|NCT02081846|OG000|Outcome|Home Nurse Visit|"Families in this arm will receive a nurse home visit within 96 hours of discharge.~Nurse Home Visit: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a nurse home visit program, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants) and re-engineered through Aim 2, in improving pediatric patient transitions from hospital to home"
11183572|NCT02081846|OG001|Outcome|Control|"This arm will receive standard of care.~Standard of Care: Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside."
11183573|NCT02081846|EG000|Reported Event|Home Nurse Visit|"Families in this arm will receive a nurse home visit within 96 hours of discharge.~Nurse Home Visit: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a nurse home visit program, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants) and re-engineered through Aim 2, in improving pediatric patient transitions from hospital to home"
11183574|NCT02081846|EG001|Reported Event|Control|"This arm will receive standard of care.~Standard of Care: Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside."
11183575|NCT02081859|BG000|Baseline|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
11183576|NCT02081859|BG001|Baseline|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
11183577|NCT02081859|BG002|Baseline|Total|Total of all reporting groups
11183578|NCT02081859|FG000|Participant Flow|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
11183579|NCT02081859|FG001|Participant Flow|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
11183580|NCT02081859|OG000|Outcome|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
11183581|NCT02081859|OG001|Outcome|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
11183582|NCT02081859|EG000|Reported Event|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
11183583|NCT02081859|EG001|Reported Event|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
11183584|NCT02081950|BG000|Baseline|Clexane - PK Population|"Eligible subjects received two doses of s.c. Clexane over 2 Treatment Periods (1 dose/period).~Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until 36 hours (h) post-dose (evening of Day 2). Study drug was administered on the morning of Day 1 following an overnight fast.~There were at least 7 days between each dose administration. In period 1, one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection.~In period 2 one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection."
11183585|NCT02081950|FG000|Participant Flow|Clexane 80 mg|"Eligible subjects received two doses of s.c. Clexane over 2 Treatment Periods (1 dose/period).~Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until 36 hours (h) post-dose (evening of Day 2). Study drug was administered on the morning of Day 1 following an overnight fast.~There were at least 7 days between each dose administration. In period 1, one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection.~In period 2 one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection."
11183586|NCT02081950|OG000|Outcome|Treatment Period 1|"Eligible subjects received two doses of s.c. Clexane over 2 Treatment Periods (1 dose/period).~Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until 36 hours (h) post-dose (evening of Day 2). Study drug was administered on the morning of Day 1 following an overnight fast.~There were at least 7 days between each dose administration. In period 1, one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection."
11183587|NCT02081950|OG001|Outcome|Treatment Period 2|"Eligible subjects received two doses of s.c. Clexane over 2 Treatment Periods (1 dose/period).~Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until 36 hours (h) post-dose (evening of Day 2). Study drug was administered on the morning of Day 1 following an overnight fast.~There were at least 7 days between each dose administration. In period 2 one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection."
11183588|NCT02081950|EG000|Reported Event|Treatment Period 1|"Eligible subjects received two doses of s.c. Clexane over 2 Treatment Periods (1 dose/period).~Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until 36 hours (h) post-dose (evening of Day 2). Study drug was administered on the morning of Day 1 following an overnight fast.~There were at least 7 days between each dose administration. In period 1, one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection."
11183589|NCT02081950|EG001|Reported Event|Treatment Period 2|"Eligible subjects received two doses of s.c. Clexane over 2 Treatment Periods (1 dose/period).~Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until 36 hours (h) post-dose (evening of Day 2). Study drug was administered on the morning of Day 1 following an overnight fast.~There were at least 7 days between each dose administration. In period 2 one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection."
11183590|NCT02081963|BG000|Baseline|Nebulized Amikacin|"Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.~Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment."
11183591|NCT02081963|BG001|Baseline|Nebulized Normal Saline|"Participants received nebulized normal saline BID for 14 days in combination with standard treatment.~Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment."
11183592|NCT02081963|BG002|Baseline|Total|Total of all reporting groups
11183593|NCT02081963|FG000|Participant Flow|Nebulized Amikacin|"Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.~Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment."
11183594|NCT02081963|FG001|Participant Flow|Nebulized Normal Saline|"Participants received nebulized normal saline BID for 14 days in combination with standard treatment.~Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment."
11183595|NCT02081963|OG000|Outcome|Nebulized Amikacin|"Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.~Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment."
11183596|NCT02081963|OG001|Outcome|Nebulized Normal Saline|"Participants received nebulized normal saline BID for 14 days in combination with standard treatment.~Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment."
11183597|NCT02081963|EG000|Reported Event|Nebulized Amikacin|"Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.~Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment."
11183598|NCT02081963|EG001|Reported Event|Nebulized Normal Saline|"Participants received nebulized normal saline BID for 14 days in combination with standard treatment.~Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment."
11183599|NCT02082119|BG000|Baseline|High Grade Glioma|"To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed High Grade Glioma after biopsy.total dose of 60 Gy/ 4 Gy fraction/15 fractions (BED10 84 Gy) will prescribed to the PTV1; a total dose of 42 Gy/2.8 Gy fraction/15 fractions (BED10 53.76 Gy) will prescribed to PTV2 with SIB.~Hypofractionated IMRT: Hypofractionated IMRT"
11183600|NCT02082119|FG000|Participant Flow|High Grade Glioma|"To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed High Grade Glioma after biopsy.total dose of 60 Gy/ 4 Gy fraction/15 fractions (BED10 84 Gy) will prescribed to the PTV1; a total dose of 42 Gy/2.8 Gy fraction/15 fractions (BED10 53.76 Gy) will prescribed to PTV2 with SIB.~Hypofractionated IMRT: Hypofractionated IMRT"
11183601|NCT02082119|OG000|Outcome|High Grade Glioma|"To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed High Grade Glioma after biopsy.total dose of 60 Gy/ 4 Gy fraction/15 fractions (BED10 84 Gy) will prescribed to the PTV1; a total dose of 42 Gy/2.8 Gy fraction/15 fractions (BED10 53.76 Gy) will prescribed to PTV2 with SIB.~Hypofractionated IMRT: Hypofractionated IMRT"
11183602|NCT02082119|EG000|Reported Event|High Grade Glioma|"To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed High Grade Glioma after biopsy.total dose of 60 Gy/ 4 Gy fraction/15 fractions (BED10 84 Gy) will prescribed to the PTV1; a total dose of 42 Gy/2.8 Gy fraction/15 fractions (BED10 53.76 Gy) will prescribed to PTV2 with SIB.~Hypofractionated IMRT: Hypofractionated IMRT"
11183603|NCT02082145|BG000|Baseline|Control|Treated according to local protocol for diabetic peripheral neuropathy
11183604|NCT02082145|BG001|Baseline|NMES|Treated with neuromuscular stimulation of both legs for 10 weeks
11183605|NCT02082145|BG002|Baseline|Total|Total of all reporting groups
11183606|NCT02082145|FG000|Participant Flow|Control|Treated according to local protocol for diabetic peripheral neuropathy
11183607|NCT02082145|FG001|Participant Flow|NMES|Treated with neuromuscular stimulation of both legs for 10 weeks
11183608|NCT02082145|OG000|Outcome|Control (Week 0)|week 0 - Treated according to local protocol for diabetic peripheral neuropathy
11183609|NCT02082145|OG001|Outcome|Control (Week 10)|week 10 - Treated according to local protocol for diabetic peripheral neuropathy
11183610|NCT02082145|OG002|Outcome|NMES (Week 0)|week 0 - Treated with neuromuscular stimulation of both legs
11183611|NCT02082145|OG003|Outcome|NMES (Week 10)|week 10 - Treated with neuromuscular stimulation of both legs
11183612|NCT02082145|EG000|Reported Event|Control|Treated according to local protocol for diabetic peripheral neuropathy
11183613|NCT02082145|EG001|Reported Event|NMES|Treated with neuromuscular st8imulation of both legs
11183614|NCT02082158|BG000|Baseline|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.~Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183615|NCT02082158|BG001|Baseline|Non-Local Respirator Model|"Subjects randomized to a current respirator design will wear that model while participating in study activities.~Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183616|NCT02082158|BG002|Baseline|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183617|NCT02082158|BG003|Baseline|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183618|NCT02082158|BG004|Baseline|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183619|NCT02082158|BG005|Baseline|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183620|NCT02082158|BG006|Baseline|Total|Total of all reporting groups
11183621|NCT02082158|FG000|Participant Flow|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.~Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
11183622|NCT02082158|FG001|Participant Flow|Non-Local Respirator Model|"Subjects randomized to the non-local respirator design will wear that model while participating in study activities.~Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
11183623|NCT02082158|FG002|Participant Flow|Prototype 1 Respirator Design|"Subjects randomized to Prototype 1 respirator design will wear that model while participating in study activities.~Prototype 1 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183624|NCT02082158|FG003|Participant Flow|Prototype 2 Respirator Design|"Subjects randomized to Prototype 2 respirator design will wear that model while participating in study activities.~Prototype 2 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183625|NCT02082158|FG004|Participant Flow|Prototype 3 Respirator Design|"Subjects randomized to Prototype 3 respirator design will wear that model while participating in study activities.~Prototype 3 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11235439|NCT02443298|FG000|Participant Flow|Risankizumab|Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20)
11235440|NCT02443298|FG001|Participant Flow|Placebo|Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20)
11235441|NCT02443298|OG000|Outcome|Risankizumab|Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20)
11235442|NCT02443298|OG001|Outcome|Placebo|Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20)
11235443|NCT02443298|EG000|Reported Event|Risankizumab|Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20)
11235444|NCT02443298|EG001|Reported Event|Placebo|Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20)
11235445|NCT02443337|BG000|Baseline|Lead in Cohort LY3023414 + Necitumumab|200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235446|NCT02443337|BG001|Baseline|Post Lead in Cohort LY3023414 + Necitumumab|200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235447|NCT02443337|BG002|Baseline|Total|Total of all reporting groups
11235448|NCT02443337|FG000|Participant Flow|Lead in Cohort LY3023414 + Necitumumab|200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235449|NCT02443337|FG001|Participant Flow|Post Lead in Cohort LY3023414 + Necitumumab|200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235450|NCT02443337|OG000|Outcome|Lead in Cohort LY3023414 + Necitumumab|200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235451|NCT02443337|OG001|Outcome|Post Lead in Cohort LY3023414 + Necitumumab|200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235452|NCT02443337|OG000|Outcome|Lead in Cohort LY3023414 + Necitumumab|LY3023414 administered orally twice daily and necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235453|NCT02443337|OG001|Outcome|Post Lead in Cohort LY3023414 + Necitumumab|LY3023414 administered orally twice daily and necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235454|NCT02443337|OG000|Outcome|LY3023414|200 milligrams (mg) LY3023414 administered orally twice daily.
11235455|NCT02443337|OG001|Outcome|Necitumumab|800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles).
11235456|NCT02443337|OG001|Outcome|Necitumumab|800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235457|NCT02443337|EG000|Reported Event|Lead in Cohort LY3023414 + Necitumumab|200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235458|NCT02443337|EG001|Reported Event|Post Lead in Cohort LY3023414 + Necitumumab|200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
11235459|NCT02443402|BG000|Baseline|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
11235460|NCT02443402|BG001|Baseline|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
11235461|NCT02443402|BG002|Baseline|Total|Total of all reporting groups
11235462|NCT02443402|FG000|Participant Flow|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
11235463|NCT02443402|FG001|Participant Flow|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
11235464|NCT02443402|OG000|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
11235465|NCT02443402|OG001|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
11235466|NCT02443402|EG000|Reported Event|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
11235467|NCT02443402|EG001|Reported Event|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
11341434|NCT03682120|FG002|Participant Flow|15 mcg A/H7N9+MF59|"15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent inactivated, subunit influenza virus vaccine containing the HA and NA from influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS genes from A/Puerto Rico/8/1934 (H1N1).~MF59 adjuvant: Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11235468|NCT02443519|BG000|Baseline|MBCT for Migraine|"In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day & Thorn). Participants will attend weekly 75-90 minute individual sessions for eight weeks. At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain). Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc). Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.~MBCT for Migraine: 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework"
11235469|NCT02443519|BG001|Baseline|Wait List/Treatment as Usual|Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
11235470|NCT02443519|BG002|Baseline|Total|Total of all reporting groups
11235471|NCT02443519|FG000|Participant Flow|MBCT for Migraine|"In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day & Thorn). Participants will attend weekly 75-90 minute individual sessions for eight weeks. At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain). Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc). Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.~MBCT for Migraine: 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework"
11235472|NCT02443519|FG001|Participant Flow|Wait List/Treatment as Usual|Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
11235473|NCT02443519|OG000|Outcome|MBCT for Migraine|"In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day & Thorn). Participants will attend weekly 75-90 minute individual sessions for eight weeks. At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain). Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc). Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.~MBCT for Migraine: 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework"
11235474|NCT02443519|OG001|Outcome|Wait List/Treatment as Usual|Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
11235475|NCT02443519|EG000|Reported Event|MBCT for Migraine|"In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day & Thorn). Participants will attend weekly 75-90 minute individual sessions for eight weeks. At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain). Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc). Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.~MBCT for Migraine: 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework"
11235476|NCT02443519|EG001|Reported Event|Wait List/Treatment as Usual|Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
11235477|NCT02443571|BG000|Baseline|Recurrent Prostate Cancer|Recurrent Prostate Cancer
11235478|NCT02443571|BG001|Baseline|Primary Prostate Cancer|Primary Prostate Cancer
11235479|NCT02443571|BG002|Baseline|Other Cancers|Other Cancers
11235480|NCT02443571|BG003|Baseline|Total|Total of all reporting groups
11235481|NCT02443571|FG000|Participant Flow|Recurrent Prostate Cancer|Recurrent Prostate Cancer
11235482|NCT02443571|FG001|Participant Flow|Primary Prostate Cancer|Primary Prostate Cancer
11235483|NCT02443571|FG002|Participant Flow|Other Cancers|Other Cancers
11235484|NCT02443571|OG000|Outcome|Recurrent Prostate Cancer|Recurrent Prostate Cancer
11235485|NCT02443571|OG001|Outcome|Primary Prostate Cancer|Primary Prostate Cancer
11235486|NCT02443571|OG002|Outcome|Other Cancers|Other Cancers
11235487|NCT02443571|OG000|Outcome|Recurrent Prostate Cancer|Recurrent prostate Cancer
11235488|NCT02443571|OG000|Outcome|Primary Prostate Cancer|Primary Prostate Cancer
11235489|NCT02443571|EG000|Reported Event|18F-Fluciclovine PET|18F-Fluciclovine PET
11235490|NCT02443688|BG000|Baseline|100 mg CTX-4430|"Once daily oral capsule for 48 weeks~CTX-4430"
11235491|NCT02443688|BG001|Baseline|50 mg CTX-4430|"Once daily oral capsule for 48 weeks~CTX-4430"
11235492|NCT02443688|BG002|Baseline|Matching Placebo|"Once daily oral capsule for 48 weeks~Placebo"
11235493|NCT02443688|BG003|Baseline|Total|Total of all reporting groups
11235494|NCT02443688|FG000|Participant Flow|100 mg CTX-4430|"Once daily oral capsule for 48 weeks~CTX-4430"
11235495|NCT02443688|FG001|Participant Flow|50 mg CTX-4430|"Once daily oral capsule for 48 weeks~CTX-4430"
11235496|NCT02443688|FG002|Participant Flow|Matching Placebo|"Once daily oral capsule for 48 weeks~Placebo"
11235497|NCT02443688|OG000|Outcome|100 mg CTX-4430|"Once daily oral capsule for 48 weeks~CTX-4430"
11235498|NCT02443688|OG001|Outcome|50 mg CTX-4430|"Once daily oral capsule for 48 weeks~CTX-4430"
11235499|NCT02443688|OG002|Outcome|Pooled CTX-4430|The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
11235500|NCT02443688|OG003|Outcome|Matching Placebo|Once daily oral capsule for 48 weeks
11235501|NCT02443688|OG002|Outcome|Pooled CTX-4430|Once daily oral 100mg and 50mg pooled results
11235502|NCT02443688|OG003|Outcome|Matching Placebo|"Once daily oral capsule for 48 weeks~Placebo"
11235503|NCT02443688|OG002|Outcome|Pooled CTX-4430|Once daily oral 100mg and 50mg pooled results.
11183626|NCT02082158|FG005|Participant Flow|Prototype 4 Respirator Design|"Subjects randomized to Prototype 4 respirator design will wear that model while participating in study activities.~Prototype 4 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183627|NCT02082158|OG000|Outcome|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183628|NCT02082158|OG001|Outcome|Non-Local Respirator Model|"Subjects randomized to the non-local respirator model will wear that model while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183629|NCT02082158|OG002|Outcome|Prototype 1 Respirator Design|"Subjects randomized to the Prototype 1 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183630|NCT02082158|OG003|Outcome|Prototype 2 Respirator Design|"Subjects randomized to the Prototype 2 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183631|NCT02082158|OG004|Outcome|Prototype 3 Respirator Design|"Subjects randomized to the Prototype 3 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183632|NCT02082158|OG005|Outcome|Prototype 4 Respirator Design|"Subjects randomized to the Prototype 4 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183633|NCT02082158|OG000|Outcome|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.~Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
11183634|NCT02082158|OG001|Outcome|Non-Local Respirator Model|"Subjects randomized to a non-local respirator model will wear that model while participating in study activities.~Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
11183635|NCT02082158|OG002|Outcome|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 1 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183636|NCT02082158|OG003|Outcome|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 2 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183637|NCT02082158|OG004|Outcome|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 3 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183638|NCT02082158|OG005|Outcome|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 4 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
11183639|NCT02082158|EG000|Reported Event|Local Respirator Model|Subjects randomized to the local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
11183640|NCT02082158|EG001|Reported Event|Non-Local Respirator Model|Subjects randomized to the non-local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
11183641|NCT02082158|EG002|Reported Event|Prototype 1 Respirator Design|Subjects randomized to Prototype 1 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
11183642|NCT02082158|EG003|Reported Event|Prototype 2 Respirator Design|Subjects randomized to Prototype 2 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
11183643|NCT02082158|EG004|Reported Event|Prototype 3 Respirator Design|Subjects randomized to Prototype 3 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
11183644|NCT02082158|EG005|Reported Event|Prototype 4 Respirator Design|Subjects randomized to Prototype 4 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
11235504|NCT02443688|EG000|Reported Event|100 mg CTX-4430|"Once daily oral capsule for 48 weeks~CTX-4430"
11235505|NCT02443688|EG001|Reported Event|50 mg CTX-4430|"Once daily oral capsule for 48 weeks~CTX-4430"
11235506|NCT02443688|EG002|Reported Event|Matching Placebo|"Once daily oral capsule for 48 weeks~Placebo"
11235507|NCT02443740|BG000|Baseline|Cohort 1|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: Placebo, PF-05251749 30 mg, 250 mg and 500 mg; PF-05251749 3 mg, placebo, PF-05251749 250 mg and 500 mg; PF-05251749 3 mg, 30 mg, placebo and PF-05251749 500 mg; PF-05251749 3 mg, 30 mg, 250 mg and placebo in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
11235508|NCT02443740|BG001|Baseline|Cohort 2|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 placebo, PF-05251749 100mg, PF-05251749 500mg, PF-05251749 1000mg; PF-05251749 10mg, PF-05251749 placebo, PF-05251749 500mg, PF-05251749 1000mg; PF-05251749 10mg, PF-05251749 100mg, PF-05251749 placebo, PF-05251749 1000mg and PF-05251749 10mg, PF-05251749 100mg, PF-05251749 500mg, PF-05251749 placebo in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
11235509|NCT02443740|BG002|Baseline|Cohort 3|Participants received a single oral dose of PF-05251749 500 mg suspension on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
11235510|NCT02443740|BG003|Baseline|Cohort 4|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (2 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 500mg unmilled, PF-05251749 500mg milled and PF-05251749 500mg milled, PF-05251749 500mg unmilled in Intervention Period 1 and 2. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
11235511|NCT02443740|BG004|Baseline|Total|Total of all reporting groups
11235512|NCT02443740|FG000|Participant Flow|Cohort 1 PF-05251749: Placebo + 30 mg + 250 mg + 500 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: Placebo, PF-05251749 30 milligram (mg), 250 mg and 500 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
11235513|NCT02443740|FG001|Participant Flow|Cohort 1 PF-05251749: 3 mg + Placebo + 250 mg + 500 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 3 mg, placebo, PF-05251749 250 mg and 500 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
11235514|NCT02443740|FG002|Participant Flow|Cohort 1 PF-05251749: 3 mg + 30 mg + Placebo + 500 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 3 mg, 30 mg, placebo and PF-05251749 500 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
11235515|NCT02443740|FG003|Participant Flow|Cohort 1 PF-05251749: 3 mg + 30 mg + 250 mg + Placebo|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 3 mg, 30 mg, 250 mg and placebo in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
11235516|NCT02443740|FG004|Participant Flow|Cohort 2 PF-05251749: Placebo + 100 mg + 500 mg + 1000 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 placebo, PF-05251749 100 mg, PF-05251749 500 mg, PF-05251749 1000 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
11235517|NCT02443740|FG005|Participant Flow|Cohort 2 PF-05251749: 10 mg + Placebo + 500 mg + 1000 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 10 mg, PF-05251749 placebo, PF-05251749 500 mg, PF-05251749 1000 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
11235518|NCT02443740|FG006|Participant Flow|Cohort 2 PF-05251749: 10 mg + 100 mg + Placebo + 1000 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 10 mg, PF-05251749 100 mg, PF-05251749 placebo, PF-05251749 1000 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
11235519|NCT02443740|FG007|Participant Flow|Cohort 2 PF-05251749: 10 mg + 100 mg + 500 mg + Placebo|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 10 mg, PF-05251749 100 mg, PF-05251749 500 mg, PF-05251749 placebo in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
11235520|NCT02443740|FG008|Participant Flow|Cohort 3 PF-05251749: 500 mg|Participants received a single oral dose of PF-05251749 500 mg suspension on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
11235521|NCT02443740|FG009|Participant Flow|Cohort 4 PF-05251749: 500 mg Unmilled + 500 mg Milled|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (2 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 500mg unmilled, PF-05251749 500mg milled in Intervention Period 1 and 2. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
11235522|NCT02443740|FG010|Participant Flow|Cohort 4 PF-05251749: 500 mg Milled + 500 mg Unmilled|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (2 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 500 mg milled, PF-05251749 500 mg unmilled in Intervention Period 1 and 2. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
11235523|NCT02443740|OG000|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
11235524|NCT02443740|OG001|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
11235525|NCT02443740|OG002|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
11235526|NCT02443740|OG003|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
11235527|NCT02443740|OG004|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
11235528|NCT02443740|OG005|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
11235529|NCT02443740|OG006|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
11235530|NCT02443740|OG007|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
11235531|NCT02443740|OG008|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
11235532|NCT02443740|OG009|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
11235533|NCT02443740|OG010|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
11235534|NCT02443740|OG011|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
11235535|NCT02443740|OG000|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
11235536|NCT02443740|OG001|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
11235537|NCT02443740|OG000|Outcome|Cohort 3: PF-05251749 500 mg (Plasma CSF Concentration)|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
11235538|NCT02443740|OG001|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1.
11235539|NCT02443740|EG000|Reported Event|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
11235540|NCT02443740|EG001|Reported Event|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
11235541|NCT02443740|EG002|Reported Event|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
11235542|NCT02443740|EG003|Reported Event|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
11235543|NCT02443740|EG004|Reported Event|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
11235544|NCT02443740|EG005|Reported Event|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
11235545|NCT02443740|EG006|Reported Event|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
11235546|NCT02443740|EG007|Reported Event|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
11235547|NCT02443740|EG008|Reported Event|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
11235548|NCT02443740|EG009|Reported Event|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
11235549|NCT02443740|EG010|Reported Event|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
11235550|NCT02443740|EG011|Reported Event|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
11235551|NCT02443792|BG000|Baseline|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
11235552|NCT02443792|BG001|Baseline|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
11235553|NCT02443792|BG002|Baseline|Total|Total of all reporting groups
11235554|NCT02443792|FG000|Participant Flow|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
11235555|NCT02443792|FG001|Participant Flow|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
11235556|NCT02443792|OG000|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
11235557|NCT02443792|OG001|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
11235558|NCT02443792|EG000|Reported Event|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
11235559|NCT02443792|EG001|Reported Event|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
11235560|NCT02443805|BG000|Baseline|300 IR|300 IR tablet of HDM Allergen Extracts
11235561|NCT02443805|BG001|Baseline|Placebo|Placebo tablet
11235562|NCT02443805|BG002|Baseline|Total|Total of all reporting groups
11235563|NCT02443805|FG000|Participant Flow|300 IR|300 IR tablet of HDM Allergen Extracts
11235564|NCT02443805|FG001|Participant Flow|Placebo|Placebo tablet
11235565|NCT02443805|OG000|Outcome|300 IR|300 IR tablet of HDM Allergen Extracts
11235566|NCT02443805|OG001|Outcome|Placebo|Placebo tablet
11235567|NCT02443805|EG000|Reported Event|300 IR|300 IR tablet of HDM Allergen Extracts
11235568|NCT02443805|EG001|Reported Event|Placebo|Placebo tablet
11235569|NCT02443883|BG000|Baseline|Ramucirumab Regimen 1|Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
11235570|NCT02443883|BG001|Baseline|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
11235571|NCT02443883|BG002|Baseline|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
11235572|NCT02443883|BG003|Baseline|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
11235573|NCT02443883|BG004|Baseline|Total|Total of all reporting groups
11235574|NCT02443883|FG000|Participant Flow|Ramucirumab Regimen 1|Ramucirumab (8milligram per kilogram [mg/kg]) given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
11235575|NCT02443883|FG001|Participant Flow|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
11235576|NCT02443883|FG002|Participant Flow|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
11235577|NCT02443883|FG003|Participant Flow|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
11235578|NCT02443883|OG000|Outcome|Ramucirumab Regimen 1|Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
11235579|NCT02443883|OG001|Outcome|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
11235580|NCT02443883|OG002|Outcome|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
11235581|NCT02443883|OG003|Outcome|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
11235582|NCT02443883|EG000|Reported Event|Ramucirumab Regimen 1|Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
11235583|NCT02443883|EG001|Reported Event|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
11235584|NCT02443883|EG002|Reported Event|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
11235585|NCT02443883|EG003|Reported Event|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
11235586|NCT02444143|BG000|Baseline|Ideal Body Weight- Tacrolimus Extended Release|tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on Ideal Body Weight (IBW)
11235587|NCT02444143|BG001|Baseline|Adjusted Body Weight-Tacrolimus Extended Release|tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on adjusted Body Weight (aBW)
11235588|NCT02444143|BG002|Baseline|Total|Total of all reporting groups
11235589|NCT02444143|FG000|Participant Flow|Ideal Body Weight- Tacrolimus Extended Release|tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on Ideal Body Weight (IBW)
11235590|NCT02444143|FG001|Participant Flow|Adjusted Body Weight-Tacrolimus Extended Release|tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on adjusted Body Weight (aBW)
11235591|NCT02444143|OG000|Outcome|Ideal Body Weight- Tacrolimus Extended Release|tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on Ideal Body Weight (IBW)
11235592|NCT02444143|OG001|Outcome|Adjusted Body Weight-Tacrolimus Extended Release|tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on adjusted Body Weight (aBW)
11235593|NCT02444143|OG000|Outcome|Ideal Body Weight|Astagraf 0.15 mg/kg/day based on ideal body weight (IBW)
11235594|NCT02444143|OG001|Outcome|Adjusted Body Weight|Astagraf 0.15 mg/kg/day based on adjusted body weight (aBW)
11235595|NCT02444143|EG000|Reported Event|Ideal Body Weight- Tacrolimus Extended Release|tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on Ideal Body Weight (IBW)
11235596|NCT02444143|EG001|Reported Event|Adjusted Body Weight-Tacrolimus Extended Release|tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on adjusted Body Weight (aBW)
11235597|NCT02444182|BG000|Baseline|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
11235598|NCT02444182|BG001|Baseline|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
11235599|NCT02444182|BG002|Baseline|Total|Total of all reporting groups
11235600|NCT02444182|FG000|Participant Flow|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
11235601|NCT02444182|FG001|Participant Flow|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
11235602|NCT02444182|OG000|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
11235603|NCT02444182|OG001|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
11235604|NCT02444182|EG000|Reported Event|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
11235605|NCT02444182|EG001|Reported Event|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
11235606|NCT02444234|BG000|Baseline|All Study Participants|Participants were randomized to receive either tedizolid oral 200 mg tablet or IV 200 mg once daily for 3 days and crossed over to either IV or PO after a minimum of 2 day washout period
11235607|NCT02444234|FG000|Participant Flow|Tedizolid PO/IV|"Tedizolid phophate 200mg tablet with crossover to IV~Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a minimum 2-day washout."
11235608|NCT02444234|FG001|Participant Flow|Tedizolid IV/PO|"Tedizolid phophate 200mg IV with crossover to PO~Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a minimum 2-day washout."
11235609|NCT02444234|OG000|Outcome|Tedizolid PO|"Tedizolid phophate 200mg tablet with crossover to IV~Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout."
11235610|NCT02444234|OG001|Outcome|Tedizolid IV|"Tedizolid phophate 200mg IV with crossover to PO~Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout."
11235611|NCT02444234|OG000|Outcome|Tedizolid PO|"Tedizolid phophate 200mg tablet~Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout."
11235612|NCT02444234|OG001|Outcome|Tedizolid IV|"Tedizolid phophate 200mg IV~Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout."
11235613|NCT02444234|EG000|Reported Event|Tedizolid PO|"Tedizolid phophate 200mg tablet~Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout."
11235614|NCT02444234|EG001|Reported Event|Tedizolid IV|"Tedizolid phophate 200mg IV~Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout."
11235615|NCT02444533|BG000|Baseline|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
11235616|NCT02444533|BG001|Baseline|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
11235617|NCT02444533|BG002|Baseline|Total|Total of all reporting groups
11235618|NCT02444533|FG000|Participant Flow|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
11235619|NCT02444533|FG001|Participant Flow|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
11235620|NCT02444533|OG000|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
11235621|NCT02444533|OG001|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
11235622|NCT02444533|EG000|Reported Event|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy.~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
11183645|NCT02082184|BG000|Baseline|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
11183646|NCT02082184|BG001|Baseline|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
11183647|NCT02082184|BG002|Baseline|Total|Total of all reporting groups
11183648|NCT02082184|FG000|Participant Flow|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
11183649|NCT02082184|FG001|Participant Flow|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
11183650|NCT02082184|OG000|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
11183651|NCT02082184|OG001|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
11183652|NCT02082184|EG000|Reported Event|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
11183653|NCT02082184|EG001|Reported Event|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
11183654|NCT02082210|BG000|Baseline|Part A - 750 mg Emibetuzumab|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183655|NCT02082210|BG001|Baseline|Part A - 2000 mg Emibetuzumab|Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183656|NCT02082210|BG002|Baseline|Part B - Gastric|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183657|NCT02082210|BG003|Baseline|Part B - HCC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183658|NCT02082210|BG004|Baseline|Part B - RCC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183659|NCT02082210|BG005|Baseline|Part B - NSCLC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183660|NCT02082210|BG006|Baseline|Total|Total of all reporting groups
11183661|NCT02082210|FG000|Participant Flow|Part A - 750 mg Emibetuzumab|Participants received 8 milligram per kilogram (mg/kg) Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183662|NCT02082210|FG001|Participant Flow|Part A - 2000 mg Emibetuzumab|Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183663|NCT02082210|FG002|Participant Flow|Part B - Gastric|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11235623|NCT02444533|EG001|Reported Event|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
11235624|NCT02444663|BG000|Baseline|All Participants|All participants
11235625|NCT02444663|FG000|Participant Flow|All Study Participants|All study participants Clinician Valgus Clinician Varus Device Valgus 0N Device Valgus 10N Device Valgus 20N Device Valgus 30N Device Varus 0N Device Varus 10N Device Varus 20N Device Varus 30N
11235626|NCT02444663|OG000|Outcome|Clinician Valgus|"Clinician performed fluoroscopic valgus and varus stress X-rays~Clinician Valgus: Clinician performed valgus stress X-ray under fluoroscopy"
11235627|NCT02444663|OG001|Outcome|Clinician Varus|"Clinician performed fluoroscopic varus stress X-rays~Clinician Varus: Clinician performed varus stress X-ray under fluoroscopy"
11235628|NCT02444663|OG002|Outcome|Device Valgus - 0 Newton Force|"Device performed fluoroscopic valgus stress X-rays - 0 Newton force~Device Valgus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235629|NCT02444663|OG003|Outcome|Device Valgus - 10 Newton Force|"Device performed fluoroscopic valgus stress X-rays - 10 Newton force~Device Valgus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed varus stress X-ray under fluoroscopy."
11235630|NCT02444663|OG004|Outcome|Device Valgus - 20 Newton Force|"Device performed fluoroscopic valgus stress X-rays - 20 Newton force~Device Valgus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235631|NCT02444663|OG005|Outcome|Device Valgus - 30 Newton Force|"Device performed fluoroscopic valgus stress X-rays - 30 Newton force~Device Valgus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235632|NCT02444663|OG006|Outcome|Device Varus - 0 Newton Force|"Device performed fluoroscopic varus stress X-rays - 0 Newton force~Device Varus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235633|NCT02444663|OG007|Outcome|Device Varus - 10 Newton Force|"Device performed fluoroscopic varus stress X-rays - 10 Newton force~Device Varus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235634|NCT02444663|OG008|Outcome|Device Varus - 20 Newton Force|"Device performed fluoroscopic varus stress X-rays - 20 Newton force~Device Varus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235635|NCT02444663|OG009|Outcome|Device Varus - 30 Newton Force|"Device performed fluoroscopic varus stress X-rays - 30 Newton force~Device Varus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235636|NCT02444663|EG000|Reported Event|Clinician Valgus|"Clinician performed fluoroscopic valgus and varus stress X-rays~Clinician Valgus: Clinician performed valgus stress X-ray under fluoroscopy"
11235637|NCT02444663|EG001|Reported Event|Clinician Varus|"Clinician performed fluoroscopic varus stress X-rays~Clinician Varus: Clinician performed varus stress X-ray under fluoroscopy"
11235638|NCT02444663|EG002|Reported Event|Device Valgus - 0 Newton Force|"Device performed fluoroscopic valgus stress X-rays - 0 Newton force~Device Valgus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235639|NCT02444663|EG003|Reported Event|Device Valgus - 10 Newton Force|"Device performed fluoroscopic valgus stress X-rays - 10 Newton force~Device Valgus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed varus stress X-ray under fluoroscopy."
11235640|NCT02444663|EG004|Reported Event|Device Valgus - 20 Newton Force|"Device performed fluoroscopic valgus stress X-rays - 20 Newton force~Device Valgus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235641|NCT02444663|EG005|Reported Event|Device Valgus - 30 Newton Force|"Device performed fluoroscopic valgus stress X-rays - 30 Newton force~Device Valgus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235642|NCT02444663|EG006|Reported Event|Device Varus - 0 Newton Force|"Device performed fluoroscopic varus stress X-rays - 0 Newton force~Device Varus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235643|NCT02444663|EG007|Reported Event|Device Varus - 10 Newton Force|"Device performed fluoroscopic varus stress X-rays - 10 Newton force~Device Varus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235644|NCT02444663|EG008|Reported Event|Device Varus - 20 Newton Force|"Device performed fluoroscopic varus stress X-rays - 20 Newton force~Device Varus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235645|NCT02444663|EG009|Reported Event|Device Varus - 30 Newton Force|"Device performed fluoroscopic varus stress X-rays - 30 Newton force~Device Varus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy."
11235646|NCT02444715|BG000|Baseline|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
11235647|NCT02444715|BG001|Baseline|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
11235648|NCT02444715|BG002|Baseline|Total|Total of all reporting groups
11235649|NCT02444715|FG000|Participant Flow|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
11235650|NCT02444715|FG001|Participant Flow|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
11235651|NCT02444715|OG000|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
11183664|NCT02082210|FG003|Participant Flow|Part B - HCC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183665|NCT02082210|FG004|Participant Flow|Part B - RCC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183666|NCT02082210|FG005|Participant Flow|Part B - NSCLC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183667|NCT02082210|OG000|Outcome|Part A - 750 mg Emibetuzumab|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183668|NCT02082210|OG001|Outcome|Part A - 2000 mg Emibetuzumab|Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183669|NCT02082210|OG002|Outcome|Part B - Gastric|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183670|NCT02082210|OG003|Outcome|Part B - HCC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183671|NCT02082210|OG004|Outcome|Part B - RCC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183672|NCT02082210|OG005|Outcome|Part B - NSCLC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183673|NCT02082210|OG000|Outcome|Part B - Gastric|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183674|NCT02082210|OG001|Outcome|Part B - HCC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183675|NCT02082210|OG002|Outcome|Part B - RCC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183676|NCT02082210|OG003|Outcome|Part B - NSCLC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183677|NCT02082210|OG000|Outcome|All Parts - 750 mg Emibetuzumab|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183678|NCT02082210|OG001|Outcome|All Parts - 2000 mg Emibetuzumab|Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183679|NCT02082210|OG000|Outcome|All Parts - 750mg|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183680|NCT02082210|OG001|Outcome|All Parts - 2000mg|Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183681|NCT02082210|OG002|Outcome|Part B - Gastric|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183682|NCT02082210|OG003|Outcome|Part B - HCC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183683|NCT02082210|OG004|Outcome|Part B - RCC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183684|NCT02082210|OG005|Outcome|Part B - NSCLC|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183685|NCT02082210|EG000|Reported Event|Part A - 750 mg Emibetuzumab|Participants received 8 milligram per kilogram (mg/kg) Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183686|NCT02082210|EG001|Reported Event|Part A - 2000 mg Emibetuzumab|Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183687|NCT02082210|EG002|Reported Event|Part B - Gastric|Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183688|NCT02082210|EG003|Reported Event|Part B - HCC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183689|NCT02082210|EG004|Reported Event|Part B - RCC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183690|NCT02082210|EG005|Reported Event|Part B - NSCLC|Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle.
11183691|NCT02082262|BG000|Baseline|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
11183692|NCT02082262|FG000|Participant Flow|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
11183693|NCT02082262|OG000|Outcome|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
11183694|NCT02082262|EG000|Reported Event|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
11183695|NCT02082288|BG000|Baseline|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
11183696|NCT02082288|FG000|Participant Flow|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
11235652|NCT02444715|OG001|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
11235653|NCT02444715|OG000|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
11235654|NCT02444715|EG000|Reported Event|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
11235655|NCT02444715|EG001|Reported Event|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
11235656|NCT02444793|BG000|Baseline|PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235657|NCT02444793|BG001|Baseline|PF-05082566 100 mg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235658|NCT02444793|BG002|Baseline|PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235659|NCT02444793|BG003|Baseline|PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235660|NCT02444793|BG004|Baseline|Total|Total of all reporting groups
11235661|NCT02444793|FG000|Participant Flow|PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235662|NCT02444793|FG001|Participant Flow|PF-05082566 100 mg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235663|NCT02444793|FG002|Participant Flow|PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235664|NCT02444793|FG003|Participant Flow|PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235665|NCT02444793|OG000|Outcome|PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235666|NCT02444793|OG001|Outcome|PF-05082566 100 mg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235667|NCT02444793|OG002|Outcome|PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235668|NCT02444793|OG003|Outcome|PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235669|NCT02444793|OG000|Outcome|Dose Expansion Cohort|Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers.
11235670|NCT02444793|EG000|Reported Event|PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235671|NCT02444793|EG001|Reported Event|PF-05082566 100 mg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235672|NCT02444793|EG002|Reported Event|PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235673|NCT02444793|EG003|Reported Event|PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
11235674|NCT02444936|BG000|Baseline|ZOSTAVAX|"ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection~ZOSTAVAX: Shingles vaccine"
11235675|NCT02444936|BG001|Baseline|Control|There is no drug given in this arm.
11235676|NCT02444936|BG002|Baseline|Total|Total of all reporting groups
11235677|NCT02444936|FG000|Participant Flow|ZOSTAVAX|"ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection~ZOSTAVAX: Shingles vaccine"
11235678|NCT02444936|FG001|Participant Flow|Control|There is no drug given in this arm.
11235679|NCT02444936|OG000|Outcome|ZOSTAVAX|"ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection~ZOSTAVAX: Shingles vaccine"
11235680|NCT02444936|OG001|Outcome|Control|There is no drug given in this arm.
11235681|NCT02444936|EG000|Reported Event|ZOSTAVAX|"ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection~ZOSTAVAX: Shingles vaccine"
11235682|NCT02444936|EG001|Reported Event|Control|There is no drug given in this arm.
11235683|NCT02444988|BG000|Baseline|0.9% Sodium Chloride (Saline)|"Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered"
11235684|NCT02444988|BG001|Baseline|Balanced Crystalloid|"Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered"
11235685|NCT02444988|BG002|Baseline|Total|Total of all reporting groups
11235686|NCT02444988|FG000|Participant Flow|0.9% Sodium Chloride (Saline)|"Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered"
11235687|NCT02444988|FG001|Participant Flow|Balanced Crystalloid|"Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered"
11235688|NCT02444988|OG000|Outcome|0.9% Sodium Chloride (Saline)|"Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered"
11235689|NCT02444988|OG001|Outcome|Balanced Crystalloid|"Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered"
11235690|NCT02444988|EG000|Reported Event|0.9% Sodium Chloride (Saline)|"Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered"
11235691|NCT02444988|EG001|Reported Event|Balanced Crystalloid|"Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered"
11235692|NCT02445014|BG000|Baseline|MGH SECM Imaging Capsule|Subject will swallow the new large SECM imaging capsule and images will be acquired using the SECM Imaging system.
11235693|NCT02445014|FG000|Participant Flow|MGH SECM Imaging Capsule|"Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.~MGH SECM Imaging Capsule: Imaging of the Esophagus using the SECM capsule and SECM Imaging system"
11235694|NCT02445014|OG000|Outcome|MGH SECM Imaging Capsule|"Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.~MGH SECM Imaging Capsule: Imaging of the Esophagus using the SECM capsule and SECM Imaging system"
11235695|NCT02445014|EG000|Reported Event|MGH SECM Imaging Capsule|Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system. The imaging quality will be reviewed.
11235696|NCT02445027|BG000|Baseline|Feasibility|Number of participants able to swallow the capsule and capture OCT images successfully.
11235697|NCT02445027|FG000|Participant Flow|Feasibility of Tethered Capsule Endomicroscopy|Number of participants able to swallow the capsule and capture OCT images successfully in the PCP setting.
11235698|NCT02445027|OG000|Outcome|Feasibility|Feasibility is measured by the total number of Participants able to swallow the capsule successfully.
11235699|NCT02445027|EG000|Reported Event|MGH OCT Imaging Capsule|"Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system.~MGH OCT Imaging Capsule: Imaging of the esophagus using the OCT Capsule and system."
11235700|NCT02445196|BG000|Baseline|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
11183697|NCT02082288|OG000|Outcome|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
11183698|NCT02082288|EG000|Reported Event|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
11183699|NCT02082340|BG000|Baseline|Intervention Arm|The intervention included the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet.
11183700|NCT02082340|BG001|Baseline|Control Arm|Patients included in the control arm received traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO.
11183701|NCT02082340|BG002|Baseline|Total|Total of all reporting groups
11183702|NCT02082340|FG000|Participant Flow|Intervention Arm|The intervention included the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet.
11183703|NCT02082340|FG001|Participant Flow|Control Arm|Patients included in the control arm received traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO.
11183704|NCT02082340|OG000|Outcome|Control Arm|patients included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO
11183705|NCT02082340|OG001|Outcome|Intervention Arm|The intervention includes the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet
11183706|NCT02082340|EG000|Reported Event|Intervention Arm|The intervention includes the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet.
11183707|NCT02082340|EG001|Reported Event|Control Arm|Patients included in the control arm received traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO.
11183708|NCT02082392|BG000|Baseline|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
11183709|NCT02082392|BG001|Baseline|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
11183710|NCT02082392|BG002|Baseline|Total|Total of all reporting groups
11183711|NCT02082392|FG000|Participant Flow|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
11183712|NCT02082392|FG001|Participant Flow|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
11183713|NCT02082392|OG000|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
11183714|NCT02082392|OG001|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
11183715|NCT02082392|EG000|Reported Event|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
11183716|NCT02082392|EG001|Reported Event|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
11183717|NCT02082483|BG000|Baseline|Selective Screening|"Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.~Selective Screening: Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care."
11183718|NCT02082483|BG001|Baseline|Regular Screening|Patients randomized to regular screening will be tested as per the current standard described in guidelines published by the National Kidney Foundation (e.g. annually while wait-listed for transplantation). If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.
11183719|NCT02082483|BG002|Baseline|Total|Total of all reporting groups
11183720|NCT02082483|FG000|Participant Flow|Selective Screening|"Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.~Selective Screening: Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care."
11183721|NCT02082483|FG001|Participant Flow|Regular Screening|Patients randomized to regular screening will be tested as per the current standard described in guidelines published by the National Kidney Foundation (e.g. annually while wait-listed for transplantation). If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.
11191413|NCT02132520|BG002|Baseline|Real rTMS + Real BCI Training|"Subjects will receive real rTMS followed by real BCI training.~rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.~BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen."
11191414|NCT02132520|BG003|Baseline|Total|Total of all reporting groups
11183722|NCT02082483|OG000|Outcome|Selective Screening|"Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.~Selective Screening: Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care."
11183723|NCT02082483|OG001|Outcome|Regular Screening|Patients randomized to regular screening will be tested as per the current standard described in guidelines published by the National Kidney Foundation (e.g. annually while wait-listed for transplantation). If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.
11183724|NCT02082483|OG000|Outcome|Selective or Regular Screening|"Patients to be randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.~Selective Screening: Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.~Patients randomized to regular screening will be tested as per the current standard described in guidelines published by the National Kidney Foundation (e.g. annually while wait-listed for transplantation). If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care."
11183725|NCT02082483|EG000|Reported Event|Selective Screening|"Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.~Selective Screening: Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care."
11183726|NCT02082483|EG001|Reported Event|Regular Screening|Patients randomized to regular screening will be tested as per the current standard described in guidelines published by the National Kidney Foundation (e.g. annually while wait-listed for transplantation). If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.
11183727|NCT02082522|BG000|Baseline|Photodynamic Therapy-Photofrin Plus SMC|"Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals.~As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity."
11183728|NCT02082522|BG001|Baseline|Standard Medical Care (SMC)|Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
11183729|NCT02082522|BG002|Baseline|Total|Total of all reporting groups
11183730|NCT02082522|FG000|Participant Flow|Photodynamic Therapy-Photofrin Plus SMC|"Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals.~As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity."
11183731|NCT02082522|FG001|Participant Flow|Standard Medical Care (SMC)|Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
11191415|NCT02132520|FG000|Participant Flow|Control|Subjects receiving standard-of-care physical therapy only.
11191416|NCT02132520|FG001|Participant Flow|Sham rTMS + Real BCI Training|"Subjects will receive sham rTMS followed by real BCI training.~rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.~BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen."
11341798|NCT03688620|FG000|Participant Flow|Vaccinated_AlphaRix Tetra Group|Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
11183732|NCT02082522|OG000|Outcome|Photodynamic Therapy-Photofrin Plus SMC|"Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals.~As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity."
11183733|NCT02082522|OG001|Outcome|Standard Medical Care (SMC)|Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
11183734|NCT02082522|EG000|Reported Event|Photodynamic Therapy-Photofrin Plus SMC|"Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals.~As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity."
11183735|NCT02082522|EG001|Reported Event|Standard Medical Care (SMC)|Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
11183736|NCT02082678|BG000|Baseline|Ondansetron|"Ondansetron will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.~Ondansetron: Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery."
11183737|NCT02082678|BG001|Baseline|Placebo|"Placebo will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.~Placebo: Inactive ingredient matching the active medication in appearance"
11183738|NCT02082678|BG002|Baseline|Total|Total of all reporting groups
11183739|NCT02082678|FG000|Participant Flow|Ondansetron|Ondansetron will be given at the dose of 0.5 mg twice a day. The dose may be increased from 0.5 mg twice a day to 1.0 mg twice a day at week 4 for participants with less than 30% reduction in the Hamilton Depression Rating Scale (HAMD) and/or alcohol use based on Timeline Followback (TLFB) assessment of alcohol use. An additional dose increase to 2.0 mg twice a day and 4.0 mg twice a day is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or TLFB.
11183740|NCT02082678|FG001|Participant Flow|Placebo|Placebo that matches the active medication in appearance will be started at 0.5 mg capsule twice day. The dose may be increased from 0.5 mg twice day to 1.0 mg twice a day at week 4 for participants with less than 30% reduction in the Hamilton Depression Rating Scale (HAMD) and/or alcohol use per Timeline Followback (TLFB) assessment score. An additional dose increase to 2.0 mg twice a day and 4.0 mg twice a day is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use per TLFB.
11183741|NCT02082678|OG000|Outcome|Ondansetron|"Ondansetron will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.~Ondansetron: Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery."
11183742|NCT02082678|OG001|Outcome|Placebo|"Placebo will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.~Placebo: Inactive ingredient matching the active medication in appearance"
11183743|NCT02082678|EG000|Reported Event|Ondansetron|"Ondansetron will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.~Ondansetron: Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery."
11183744|NCT02082678|EG001|Reported Event|Placebo|"Placebo will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.~Placebo: Inactive ingredient matching the active medication in appearance"
11183745|NCT02082717|BG000|Baseline|Neut (4%Sodium Bicarbonate Additive)|"4% sodium bicarbonate additive during intravenous potassium chloride replacement.~potassium chloride replacement~Experimental - 4% Sodium Bicarbonate"
11183746|NCT02082717|BG001|Baseline|Control|"standard of practice potassium chloride replacement (with no additive)~potassium chloride replacement"
11183747|NCT02082717|BG002|Baseline|Total|Total of all reporting groups
11183748|NCT02082717|FG000|Participant Flow|Neut (4%Sodium Bicarbonate Additive)|"4% sodium bicarbonate additive during intravenous potassium chloride replacement.~potassium chloride replacement~Experimental - 4% Sodium Bicarbonate"
11183749|NCT02082717|FG001|Participant Flow|Control|"standard of practice potassium chloride replacement (with no additive)~potassium chloride replacement"
11183750|NCT02082717|OG000|Outcome|Neut (4%Sodium Bicarbonate Additive)|"4% sodium bicarbonate additive during intravenous potassium chloride replacement.~potassium chloride replacement~Experimental - 4% Sodium Bicarbonate"
11183751|NCT02082717|OG001|Outcome|Control|"standard of practice potassium chloride replacement (with no additive)~potassium chloride replacement"
11183752|NCT02082717|OG000|Outcome|Neut (4%Sodium Bicarbonate Additive)|"4% sodium bicarbonate additive during intravenous potassium chloride replacement.~potassium chloride replacement~Experimental - 4% Sodium Bicarbonate~3 participants out of 8 analyzed had pain medication during randomization."
11183753|NCT02082717|OG001|Outcome|Control|"standard of practice potassium chloride replacement (with no additive)~potassium chloride replacement~O participants out of 9 had no interventions"
11183754|NCT02082717|OG000|Outcome|Neut (4%Sodium Bicarbonate Additive)|"4% sodium bicarbonate additive during intravenous potassium chloride replacement.~potassium chloride replacement~Experimental - 4% Sodium Bicarbonate~Zero attrition rate"
11183755|NCT02082717|OG001|Outcome|Control|"standard of practice potassium chloride replacement (with no additive)~potassium chloride replacement~Zero attrition rate"
11183756|NCT02082717|EG000|Reported Event|Neut (4%Sodium Bicarbonate Additive)|"4% sodium bicarbonate additive during intravenous potassium chloride replacement.~potassium chloride replacement~Experimental - 4% Sodium Bicarbonate"
11183757|NCT02082717|EG001|Reported Event|Control|"standard of practice potassium chloride replacement (with no additive)~potassium chloride replacement"
11183758|NCT02082769|BG000|Baseline|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
11183759|NCT02082769|BG001|Baseline|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
11183760|NCT02082769|BG002|Baseline|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
11183761|NCT02082769|BG003|Baseline|Total|Total of all reporting groups
11183762|NCT02082769|FG000|Participant Flow|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
11183763|NCT02082769|FG001|Participant Flow|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
11183764|NCT02082769|FG002|Participant Flow|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
11183765|NCT02082769|OG000|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
11183766|NCT02082769|OG001|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
11183767|NCT02082769|OG002|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
11183768|NCT02082769|EG000|Reported Event|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
11183769|NCT02082769|EG001|Reported Event|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
11183770|NCT02082769|EG002|Reported Event|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
11183771|NCT02082912|BG000|Baseline|D-cycloserine|Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
11183772|NCT02082912|BG001|Baseline|Placebo|Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
11183773|NCT02082912|BG002|Baseline|Total|Total of all reporting groups
11183774|NCT02082912|FG000|Participant Flow|D-cycloserine|Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
11183775|NCT02082912|FG001|Participant Flow|Placebo|Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
11183776|NCT02082912|OG000|Outcome|D-cycloserine|Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
11183777|NCT02082912|OG001|Outcome|Placebo|Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
11183778|NCT02082912|EG000|Reported Event|D-cycloserine|Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy
11183779|NCT02082912|EG001|Reported Event|Placebo|Participants taking a placebo pill and using the HandMentor Pro for robotic therapy
11183780|NCT02082977|BG000|Baseline|Part 1:GSK2816126 50 mg Twice-weekly|Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183781|NCT02082977|BG001|Baseline|Part 1:GSK2816126 100 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183782|NCT02082977|BG002|Baseline|Part 1:GSK2816126 200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183783|NCT02082977|BG003|Baseline|Part 1:GSK2816126 400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183784|NCT02082977|BG004|Baseline|Part 1:GSK2816126 800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183785|NCT02082977|BG005|Baseline|Part 1:GSK2816126 1200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183786|NCT02082977|BG006|Baseline|Part 1:GSK2816126 1800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183787|NCT02082977|BG007|Baseline|Part 1:GSK2816126 2400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183788|NCT02082977|BG008|Baseline|Part 1:GSK2816126 3000 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183789|NCT02082977|BG009|Baseline|Part 2: All Participants|Participants with Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB-DLBCL)-mutant and wild type, Transformed Follicular Lymphoma (TFL)-mutant and wild type as well as with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive recommended Phase II dose (RP2D) .
11183790|NCT02082977|BG010|Baseline|Total|Total of all reporting groups
11183791|NCT02082977|FG000|Participant Flow|Part 1:GSK2816126 50 mg Twice-weekly|Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183792|NCT02082977|FG001|Participant Flow|Part 1:GSK2816126 100 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183793|NCT02082977|FG002|Participant Flow|Part 1:GSK2816126 200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183794|NCT02082977|FG003|Participant Flow|Part 1:GSK2816126 400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183795|NCT02082977|FG004|Participant Flow|Part 1:GSK2816126 800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183796|NCT02082977|FG005|Participant Flow|Part 1:GSK2816126 1200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183797|NCT02082977|FG006|Participant Flow|Part 1:GSK2816126 1800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183798|NCT02082977|FG007|Participant Flow|Part 1:GSK2816126 2400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183799|NCT02082977|FG008|Participant Flow|Part 1:GSK2816126 3000 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183800|NCT02082977|FG009|Participant Flow|Part 2: All Participants|Participants with Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB-DLBCL)-mutant and wild type, Transformed Follicular Lymphoma (TFL)-mutant and wild type as well as with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive recommended Phase II dose (RP2D).
11183801|NCT02082977|OG000|Outcome|Part 1:GSK2816126 50 mg Twice-weekly|Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183802|NCT02082977|OG001|Outcome|Part 1:GSK2816126 100 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183803|NCT02082977|OG002|Outcome|Part 1:GSK2816126 200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183804|NCT02082977|OG003|Outcome|Part 1:GSK2816126 400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183805|NCT02082977|OG004|Outcome|Part 1:GSK2816126 800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183806|NCT02082977|OG005|Outcome|Part 1:GSK2816126 1200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183807|NCT02082977|OG006|Outcome|Part 1:GSK2816126 1800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183808|NCT02082977|OG007|Outcome|Part 1:GSK2816126 2400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183809|NCT02082977|OG008|Outcome|Part 1:GSK2816126 3000 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183810|NCT02082977|OG000|Outcome|Part 2: All Participants|Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
11183811|NCT02082977|OG000|Outcome|Part 1:GSK2816126 800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183812|NCT02082977|OG001|Outcome|Part 1:GSK2816126 1200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183813|NCT02082977|OG002|Outcome|Part 1:GSK2816126 1800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183814|NCT02082977|OG003|Outcome|Part 1:GSK2816126 2400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183815|NCT02082977|OG004|Outcome|Part 1:GSK2816126 3000 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183816|NCT02082977|OG001|Outcome|Part 1:GSK2816126 1800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183817|NCT02082977|OG002|Outcome|Part 1:GSK2816126 2400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183818|NCT02082977|OG003|Outcome|Part 1:GSK2816126 3000 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183819|NCT02082977|OG000|Outcome|Part 1: Participants With GCB-DLBCL|At maximum tolerated or recommended phase II dose, participants with GCB-DLBCL were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
11183820|NCT02082977|OG001|Outcome|Part 1: Participants With Solid Tumors|At maximum tolerated or recommended phase II dose, participants with solid tumors were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
11183821|NCT02082977|EG000|Reported Event|Part 1:GSK2816126 50 mg Twice-weekly|Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183822|NCT02082977|EG001|Reported Event|Part 1:GSK2816126 100 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183823|NCT02082977|EG002|Reported Event|Part 1:GSK2816126 200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183824|NCT02082977|EG003|Reported Event|Part 1:GSK2816126 400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183825|NCT02082977|EG004|Reported Event|Part 1:GSK2816126 800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183826|NCT02082977|EG005|Reported Event|Part 1:GSK2816126 1200 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183827|NCT02082977|EG006|Reported Event|Part 1:GSK2816126 1800 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183828|NCT02082977|EG007|Reported Event|Part 1:GSK2816126 2400 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183829|NCT02082977|EG008|Reported Event|Part 1:GSK2816126 3000 mg Twice-weekly|Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
11183830|NCT02082977|EG009|Reported Event|Part 2: All Participants|Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
11183831|NCT02083107|BG000|Baseline|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
11183832|NCT02083107|BG001|Baseline|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets and sublingual placebo2 tablets."
11183833|NCT02083107|BG002|Baseline|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
11183834|NCT02083107|BG003|Baseline|Total|Total of all reporting groups
11183835|NCT02083107|FG000|Participant Flow|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
11183836|NCT02083107|FG001|Participant Flow|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets and sublingual placebo2 tablets."
11183837|NCT02083107|FG002|Participant Flow|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
11183838|NCT02083107|OG000|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
11183839|NCT02083107|OG001|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets and sublingual placebo2 tablets."
11183840|NCT02083107|OG002|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
11183841|NCT02083107|EG000|Reported Event|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
11183842|NCT02083107|EG001|Reported Event|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets and sublingual placebo2 tablets."
11183843|NCT02083107|EG002|Reported Event|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
11183844|NCT02083185|BG000|Baseline|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
11183845|NCT02083185|BG001|Baseline|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
11183846|NCT02083185|BG002|Baseline|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
11183847|NCT02083185|BG003|Baseline|Total|Total of all reporting groups
11183848|NCT02083185|FG000|Participant Flow|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
11183849|NCT02083185|FG001|Participant Flow|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
11183850|NCT02083185|FG002|Participant Flow|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
11183851|NCT02083185|OG000|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
11183852|NCT02083185|OG001|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
11183853|NCT02083185|OG002|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
11183854|NCT02083185|EG000|Reported Event|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
11183855|NCT02083185|EG001|Reported Event|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
11183856|NCT02083185|EG002|Reported Event|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
11183857|NCT02083263|BG000|Baseline|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
11183858|NCT02083263|BG001|Baseline|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
11183859|NCT02083263|BG002|Baseline|Total|Total of all reporting groups
11183860|NCT02083263|FG000|Participant Flow|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
11183861|NCT02083263|FG001|Participant Flow|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
11183862|NCT02083263|OG000|Outcome|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
11183863|NCT02083263|OG001|Outcome|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
11183864|NCT02083263|EG000|Reported Event|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
11183865|NCT02083263|EG001|Reported Event|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
11183866|NCT02083380|BG000|Baseline|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine 640mg
11183867|NCT02083380|BG001|Baseline|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
11183868|NCT02083380|BG002|Baseline|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
11183869|NCT02083380|BG003|Baseline|Total|Total of all reporting groups
11183870|NCT02083380|FG000|Participant Flow|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
11183871|NCT02083380|FG001|Participant Flow|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
11183872|NCT02083380|FG002|Participant Flow|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
11183873|NCT02083380|OG000|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: piperaquine 640mg: Active, loose combination
11183874|NCT02083380|OG001|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
11183875|NCT02083380|OG002|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
11183876|NCT02083380|OG000|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
11183877|NCT02083380|OG002|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|C) Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
11183878|NCT02083380|OG000|Outcome|A) Arttefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
11183879|NCT02083380|OG000|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|"Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined~Artefenomel 800mg: PQP 640mg, 960mg & 1440mg"
11183880|NCT02083380|OG000|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
11183881|NCT02083380|EG000|Reported Event|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg
11183882|NCT02083380|EG001|Reported Event|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
11183883|NCT02083380|EG002|Reported Event|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
11341799|NCT03688620|FG001|Participant Flow|Vaccinated_Influsplit Tetra Group|"Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between~01 October and 31 December 2018."
11183884|NCT02083406|BG000|Baseline|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
11183885|NCT02083406|BG001|Baseline|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
11183886|NCT02083406|BG002|Baseline|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
11183887|NCT02083406|BG003|Baseline|Total|Total of all reporting groups
11183888|NCT02083406|FG000|Participant Flow|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
11183889|NCT02083406|FG001|Participant Flow|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
11183890|NCT02083406|FG002|Participant Flow|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
11183891|NCT02083406|OG000|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
11183892|NCT02083406|OG001|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
11183893|NCT02083406|OG002|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
11183894|NCT02083406|EG000|Reported Event|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
11183895|NCT02083406|EG001|Reported Event|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
11183896|NCT02083406|EG002|Reported Event|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
11183897|NCT02083653|BG000|Baseline|Arm A: Sym004 (12 mg/kg)|"Sym004 will be administered as an intravenous infusion at a dose of 12 milligrams per kilogram (mg/kg) weekly until unacceptable toxicity, disease progression, or consent withdrawal.~Sym004 (12 mg/kg): Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR."
11183898|NCT02083653|BG001|Baseline|Arm B: Sym004 (9/6 mg/kg)|"Sym004 will be administered as an intravenous infusion at a loading dose of 9 mg/kg followed by 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal.~Sym004 (9/6 mg/kg): Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR."
11183899|NCT02083653|BG002|Baseline|Arm C: Investigator's Choice|"Best supportive care (BSC) or Fluorouracil (5-FU) or Capecitabine will be given as per Investigator's discretion.~Best Supportive Care (BSC): BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.~Fluorouracil (5-FU): 5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.~Capecitabine: Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert."
11183900|NCT02083653|BG003|Baseline|Total|Total of all reporting groups
11183901|NCT02083653|FG000|Participant Flow|Arm A: Sym004 (12 mg/kg)|"Sym004 will be administered as an intravenous infusion at a dose of 12 milligrams per kilogram (mg/kg) weekly until unacceptable toxicity, disease progression, or consent withdrawal.~Sym004 (12 mg/kg): Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) (futuximab and modotuximab) which bind to two non-overlapping epitopes of the epidermal growth factor receptor (EGFR)."
11183902|NCT02083653|FG001|Participant Flow|Arm B: Sym004 (9/6 mg/kg)|"Sym004 will be administered as an intravenous infusion at a loading dose of 9 mg/kg followed by 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal.~Sym004 (9/6 mg/kg): Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR."
11183903|NCT02083653|FG002|Participant Flow|Arm C: Investigator's Choice|"Best supportive care (BSC) or Fluorouracil (5-FU) or Capecitabine will be given as per Investigator's discretion.~Best Supportive Care (BSC): BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.~Fluorouracil (5-FU): 5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.~Capecitabine: Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert."
11183904|NCT02083653|OG000|Outcome|Arm A: Sym004 (12 mg/kg)|"Sym004 will be administered as an intravenous infusion at a dose of 12 milligrams per kilogram (mg/kg) weekly until unacceptable toxicity, disease progression, or consent withdrawal.~Sym004 (12 mg/kg): Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR."
11183905|NCT02083653|OG001|Outcome|Arm B: Sym004 (9/6 mg/kg)|"Sym004 will be administered as an intravenous infusion at a loading dose of 9 mg/kg followed by 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal.~Sym004 (9/6 mg/kg): Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR."
11183906|NCT02083653|OG002|Outcome|Arm C: Investigator's Choice|"Best supportive care (BSC) or Fluorouracil (5-FU) or Capecitabine will be given as per Investigator's discretion.~Best Supportive Care (BSC): BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.~Fluorouracil (5-FU): 5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.~Capecitabine: Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert."
11183907|NCT02083653|EG000|Reported Event|Arm A: Sym004 (12 mg/kg)|"Sym004 will be administered as an intravenous infusion at a dose of 12 milligrams per kilogram (mg/kg) weekly until unacceptable toxicity, disease progression, or consent withdrawal.~Sym004 (12 mg/kg): Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR."
11183908|NCT02083653|EG001|Reported Event|Arm B: Sym004 (9/6 mg/kg)|"Sym004 will be administered as an intravenous infusion at a loading dose of 9 mg/kg followed by 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal.~Sym004 (9/6 mg/kg): Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR."
11183909|NCT02083653|EG002|Reported Event|Arm C: Investigator's Choice|"Best supportive care (BSC) or Fluorouracil (5-FU) or Capecitabine will be given as per Investigator's discretion.~Best Supportive Care (BSC): BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.~Fluorouracil (5-FU): 5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.~Capecitabine: Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert."
11183910|NCT02083679|BG000|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183911|NCT02083679|BG001|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183912|NCT02083679|BG002|Baseline|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183913|NCT02083679|BG003|Baseline|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183914|NCT02083679|BG004|Baseline|Total|Total of all reporting groups
11183915|NCT02083679|FG000|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183916|NCT02083679|FG001|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183917|NCT02083679|FG002|Participant Flow|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183918|NCT02083679|FG003|Participant Flow|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183919|NCT02083679|OG000|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183920|NCT02083679|OG001|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11341800|NCT03688620|FG002|Participant Flow|Vaccinated_Fluarix Tetra Group|"Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between~01 October and 31 December 2018."
11183921|NCT02083679|OG002|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183922|NCT02083679|OG003|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183923|NCT02083679|EG000|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183924|NCT02083679|EG001|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183925|NCT02083679|EG002|Reported Event|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183926|NCT02083679|EG003|Reported Event|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
11183927|NCT02083783|BG000|Baseline|TRI102|"Active, amphetamine extended-release oral suspension~TRI102: formulation containing active moiety (amphetamine)"
11183928|NCT02083783|BG001|Baseline|Placebo|"Placebo~Placebo: formulation without active moiety"
11183929|NCT02083783|BG002|Baseline|Total|Total of all reporting groups
11183930|NCT02083783|FG000|Participant Flow|TRI102|"Active~TRI102: formulation containing active moiety~The stable dose of TRI102 reached during the Dose Optimization Period varied between 10 to 20 mg/day and was determined based on Investigator clinical judgment and assessments of both tolerability and efficacy for each subject. The same stable dose identified for a subject during the Dose Optimization Period was administered during the double-blind Treatment Period."
11183931|NCT02083783|FG001|Participant Flow|Placebo|"Placebo~Placebo: formulation without active moiety~The same stable dose identified for a subject during the Dose Optimization Period was administered during the double-blind Treatment Period."
11183932|NCT02083783|OG000|Outcome|TRI102|"Active~TRI102: formulation containing active moiety~The stable dose of TRI102 reached during the Dose Optimization Period varied between 10 to 20 mg/day and was determined based on Investigator clinical judgment and assessments of both tolerability and efficacy for each subject. The same stable dose identified for a subject during the Dose Optimization Period was administered during the double-blind Treatment Period."
11183933|NCT02083783|OG001|Outcome|Placebo|"Placebo~Placebo: formulation without active moiety~The same stable dose identified for a subject during the Dose Optimization Period was administered during the double-blind Treatment Period."
11183934|NCT02083783|OG000|Outcome|TRI102|"Active, amphetamine extended-release oral suspension~TRI102: formulation containing active moiety (amphetamine)"
11183935|NCT02083783|OG001|Outcome|Placebo|"Placebo~Placebo: formulation without active moiety"
11183936|NCT02083783|EG000|Reported Event|TRI102|"Active, amphetamine extended-release oral suspension~TRI102: formulation containing active moiety (amphetamine)"
11183937|NCT02083783|EG001|Reported Event|Placebo|"Placebo~Placebo: formulation without active moiety"
11183938|NCT02083809|BG000|Baseline|Placebo|"500ml saline or lactated ringer without oxytocin added~Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid"
11183939|NCT02083809|BG001|Baseline|Treatment Group|"Intravenous oxytocin mixed with saline or lactated ringer~intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)"
11183940|NCT02083809|BG002|Baseline|Total|Total of all reporting groups
11183941|NCT02083809|FG000|Participant Flow|Placebo|"500ml saline or lactated ringer without oxytocin added~Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid"
11183942|NCT02083809|FG001|Participant Flow|Treatment Group|"Intravenous oxytocin mixed with saline or lactated ringer~intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)"
11183943|NCT02083809|OG000|Outcome|Placebo|"500ml saline or lactated ringer without oxytocin added~Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid"
11183944|NCT02083809|OG001|Outcome|Treatment Group|"Intravenous oxytocin mixed with saline or lactated ringer~intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)"
11183945|NCT02083809|EG000|Reported Event|Placebo|"500ml saline or lactated ringer without oxytocin added~Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid"
11235701|NCT02445196|BG001|Baseline|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
11235702|NCT02445196|BG002|Baseline|Total|Total of all reporting groups
11235703|NCT02445196|FG000|Participant Flow|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
11235704|NCT02445196|FG001|Participant Flow|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
11235705|NCT02445196|OG000|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
11235706|NCT02445196|OG001|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
11235707|NCT02445196|EG000|Reported Event|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
11235708|NCT02445196|EG001|Reported Event|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
11235709|NCT02445287|BG000|Baseline|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
11235710|NCT02445287|BG001|Baseline|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
11235711|NCT02445287|BG002|Baseline|Total|Total of all reporting groups
11235712|NCT02445287|FG000|Participant Flow|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D devices CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
11235713|NCT02445287|FG001|Participant Flow|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only.
11235714|NCT02445287|OG000|Outcome|Predicate - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
11341435|NCT03682120|FG003|Participant Flow|15 mcg A/H7N9|"15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent inactivated, subunit influenza virus vaccine containing the HA and NA from influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS genes from A/Puerto Rico/8/1934 (H1N1).~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11183946|NCT02083809|EG001|Reported Event|Treatment Group|"Intravenous oxytocin mixed with saline or lactated ringer~intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)"
11183947|NCT02083861|BG000|Baseline|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183948|NCT02083861|BG001|Baseline|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183949|NCT02083861|BG002|Baseline|Total|Total of all reporting groups
11183950|NCT02083861|FG000|Participant Flow|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183951|NCT02083861|FG001|Participant Flow|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183952|NCT02083861|OG000|Outcome|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183953|NCT02083861|OG001|Outcome|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183954|NCT02083861|OG000|Outcome|Active Ultrasound Device|"Patients (n=9) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183955|NCT02083861|OG001|Outcome|Placebo Ultrasound Device|"Patients (n=8) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183956|NCT02083861|EG000|Reported Event|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183957|NCT02083861|EG001|Reported Event|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
11183958|NCT02083926|BG000|Baseline|Ketamine Infusion on Day 0, Saline Infusion on Day 28|A ketamine infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A saline infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.
11183959|NCT02083926|BG001|Baseline|Saline Infusion on Day 0, Ketamine Infusion on Day 28|A saline infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A Ketamine infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.
11183960|NCT02083926|BG002|Baseline|Total|Total of all reporting groups
11183961|NCT02083926|FG000|Participant Flow|Ketamine Infusion on Day 0, Saline Infusion on Day 28|A ketamine infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A saline infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.
11183962|NCT02083926|FG001|Participant Flow|Saline Infusion on Day 0, Ketamine Infusion on Day 28|A saline infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A Ketamine infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.
11183963|NCT02083926|OG000|Outcome|Ketamine Infusion on Day 0 or Day 28|A ketamine infusion was given on day 0 or day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.
11235715|NCT02445287|OG001|Outcome|Investigational - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
11235716|NCT02445287|OG000|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
11235717|NCT02445287|OG001|Outcome|Invest. - Cadavers & Human Subjects 3D - High Res|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
11235718|NCT02445287|OG001|Outcome|Invest. - Cadavers & Human Subjects 3D - FDK|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
11235719|NCT02445287|OG001|Outcome|Invest. - Cadavers & Human Subjects 3D - SND|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
11235720|NCT02445287|EG000|Reported Event|Predicate & Invest.- Cadavers 2D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph.
11235721|NCT02445287|EG001|Reported Event|Reference & Invest. - Cadavers 3D|Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
11235722|NCT02445287|EG002|Reported Event|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
11235723|NCT02445326|BG000|Baseline|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11235724|NCT02445326|BG001|Baseline|Placebo Vehicle|PV (placebo drug delivery vehicle)
11235725|NCT02445326|BG002|Baseline|Total|Total of all reporting groups
11235726|NCT02445326|FG000|Participant Flow|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11235727|NCT02445326|FG001|Participant Flow|Placebo Vehicle|PV (placebo drug delivery vehicle)
11235728|NCT02445326|OG000|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11235729|NCT02445326|OG001|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
11235730|NCT02445326|EG000|Reported Event|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11235731|NCT02445326|EG001|Reported Event|Placebo Vehicle|PV (placebo drug delivery vehicle)
11235732|NCT02445573|BG000|Baseline|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
11341436|NCT03682120|OG000|Outcome|3.75 mcg A/H7N9+MF59|3.75 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11235733|NCT02445573|BG001|Baseline|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
11235734|NCT02445573|BG002|Baseline|Total|Total of all reporting groups
11235735|NCT02445573|FG000|Participant Flow|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 milliampere (mA) for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
11235736|NCT02445573|FG001|Participant Flow|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
11235737|NCT02445573|OG000|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
11235738|NCT02445573|OG001|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
11235739|NCT02445573|EG000|Reported Event|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
11235740|NCT02445573|EG001|Reported Event|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
11235741|NCT02445586|BG000|Baseline|Pertuzumab in Combination With Trastuzumab and Docetaxel|Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
11235742|NCT02445586|FG000|Participant Flow|Pertuzumab in Combination With Trastuzumab and Docetaxel|Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
11235743|NCT02445586|OG000|Outcome|Pertuzumab in Combination With Trastuzumab and Docetaxel|Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
11235744|NCT02445586|EG000|Reported Event|Pertuzumab in Combination With Trastuzumab and Docetaxel|Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
11235745|NCT02445625|BG000|Baseline|High Functioning ASD Adolescents and Adults|"The eligible patients for the study should be high functioning ASD adolescents and adults.~These participants should also meet all the following inclusion criteria and none of the exclusion criteria. All queries about patient eligibility should be directed to Susana Mouga before registration.~Positive diagnostic results for ASD in:~Autism Diagnostic Interview-Revised;~Autism Diagnostic Observation Schedule;~The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria."
11341437|NCT03682120|OG001|Outcome|7.5 mcg A/H7N9+MF59|7.5 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11235746|NCT02445625|FG000|Participant Flow|High Functioning ASD Adolescents and Adults|"The eligible patients for the study should be high functioning ASD adolescents and adults.~These participants should also meet all the following inclusion criteria and none of the exclusion criteria. All queries about patient eligibility should be directed to Susana Mouga before registration. Positive diagnostic results for ASD in:~Autism Diagnostic Interview-Revised;~Autism Diagnostic Observation Schedule;~The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria."
11235747|NCT02445625|OG000|Outcome|High Functioning ASD Adolescents and Adults|"Positive diagnostic results for ASD in:~Autism Diagnostic Interview-Revised;~Autism Diagnostic Observation Schedule;~The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria."
11235748|NCT02445625|OG000|Outcome|High Functioning ASD Adolescents and Adults|"The eligible patients for the study should be high functioning ASD adolescents and adults.~These participants should also meet all the following inclusion criteria and none of the exclusion criteria. All queries about patient eligibility should be directed to Susana Mouga before registration. Positive diagnostic results for ASD in:~Autism Diagnostic Interview-Revised;~Autism Diagnostic Observation Schedule;~The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria."
11235749|NCT02445625|EG000|Reported Event|High Functioning ASD Adolescents and Adults|"The eligible patients for the study should be high functioning ASD adolescents and adults.~These participants should also meet all the following inclusion criteria and none of the exclusion criteria. All queries about patient eligibility should be directed to Susana Mouga before registration.~● Positive diagnostic results for ASD in:~Autism Diagnostic Interview-Revised;~Autism Diagnostic Observation Schedule;~The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria."
11235750|NCT02445755|BG000|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
11235751|NCT02445755|FG000|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
11235752|NCT02445755|OG000|Outcome|BiliCare TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device
11235753|NCT02445755|OG001|Outcome|BiliCare TcB With Infection Control Tip|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device with infection control tip.
11235754|NCT02445755|OG002|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
11235755|NCT02445755|OG003|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
11235756|NCT02445755|EG000|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
11235757|NCT02445794|BG000|Baseline|Cohort 1 - RT001|RT001 - 2 capsules/day (1.8 g/day)
11235758|NCT02445794|BG001|Baseline|Cohort 1 - Comparator|RT001 comparator - 2 capsules/day
11235759|NCT02445794|BG002|Baseline|Cohort 2 - RT001|RT001 - 10 capsules/day (9 g/day)
11235760|NCT02445794|BG003|Baseline|Cohort 2 - Comparator|RT001 comparator - 10 capsules/day
11235761|NCT02445794|BG004|Baseline|Total|Total of all reporting groups
11235762|NCT02445794|FG000|Participant Flow|Cohort 1 - RT001 (1.8 g/Day)|"RT001, oral, 2 capsules/day~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001."
11235763|NCT02445794|FG001|Participant Flow|Cohort 1 - Comparator|"RT001 comparator, oral, 2 capsules/day~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235764|NCT02445794|FG002|Participant Flow|Cohort 2 - RT001 (9 g/Day)|"RT001, oral, 10 capsules/day~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001."
11235765|NCT02445794|FG003|Participant Flow|Cohort 2 - Comparator|"RT001 comparator, oral, 10 capsules/day~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235766|NCT02445794|OG000|Outcome|Cohort 1 - RT001 (1.8 g/Day)|"RT001, oral, 2 capsules/day~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001."
11235767|NCT02445794|OG001|Outcome|Cohort 1 - Comparator|"RT001 comparator, oral, 2 capsules/day~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235768|NCT02445794|OG002|Outcome|Cohort 2 - RT001 (9 g/Day)|"RT001, oral, 10 capsules/day~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001."
11235769|NCT02445794|OG003|Outcome|Cohort 2 - Comparator|"RT001 comparator, oral, 10 capsules/day~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235770|NCT02445794|OG000|Outcome|RT001, Oral, 1.8 g/Day|"RT001, oral, 1.8 g QD for 28 days or matching comparator~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235771|NCT02445794|OG001|Outcome|RT001, Oral, 9 g/Day|"RT001, oral, 4.5 g BID for 28 days or matching comparator~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235772|NCT02445794|OG001|Outcome|Cohort 2 - RT001 (9 g/Day)|"RT001, oral, 10 capsules/day~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001."
11235773|NCT02445794|OG000|Outcome|RT001|"RT001, oral (pooled 1.8 g/d + 9.0 g/d)~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001."
11235774|NCT02445794|OG001|Outcome|Cohort 1 - Comparator|"RT001 comparator, oral~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235775|NCT02445794|EG000|Reported Event|Cohort 1 - RT001 (1.8 g/Day)|"RT001, oral, 2 capsules/day~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001."
11235776|NCT02445794|EG001|Reported Event|Cohort 1 - Comparator|"RT001 comparator, oral, 2 capsules/day~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235777|NCT02445794|EG002|Reported Event|Cohort 2 - RT001 (9 g/Day)|"RT001, oral, 10 capsules/day~RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001."
11235778|NCT02445794|EG003|Reported Event|Cohort 2 - Comparator|"RT001 comparator, oral, 10 capsules/day~RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester."
11235779|NCT02445807|BG000|Baseline|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
11235780|NCT02445807|BG001|Baseline|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
11235781|NCT02445807|BG002|Baseline|Total|Total of all reporting groups
11235782|NCT02445807|FG000|Participant Flow|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
11235783|NCT02445807|FG001|Participant Flow|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
11235784|NCT02445807|OG000|Outcome|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
11235785|NCT02445807|OG001|Outcome|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
11235786|NCT02445807|EG000|Reported Event|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
11235787|NCT02445807|EG001|Reported Event|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
11235788|NCT02445859|BG000|Baseline|Standard Dosing|Intravenous (IV) cefuroxime 1.5g bolus administered four-hourly throughout surgery
11235789|NCT02445859|BG001|Baseline|Intervention Dosing|Cefuroxime bolus-continuous dosing was based on targeting non-protein bound (free) serum concentrations of antibiotic at 64mg/L throughout surgery
11235790|NCT02445859|BG002|Baseline|Total|Total of all reporting groups
11235791|NCT02445859|FG000|Participant Flow|Standard Regimen|"Cefuroxime 1.5grams pre-operatively Repeated every 4 hours~Cefuroxime bolus-continuous infusion: Cefuroxime 1.5 grams pre-operatively, repeated 4 hourly during surgery."
11235792|NCT02445859|FG001|Participant Flow|Interventional Regimen|"Cefuroxime continuous infusion targeting 64mg/l serum concentrations.~Cefuroxime 4 hourly bolus: Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L."
11235793|NCT02445859|OG000|Outcome|Standard Regimen|"Cefuroxime 1.5grams pre-operatively Repeated every 4 hours~Cefuroxime bolus-continuous infusion: Cefuroxime 1.5 grams pre-operatively, repeated 4 hourly during surgery."
11235794|NCT02445859|OG001|Outcome|Interventional Regimen|"Cefuroxime continuous infusion targeting 64mg/l serum concentrations.~Cefuroxime 4 hourly bolus: Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L."
11235795|NCT02445859|EG000|Reported Event|Standard Regimen|"Cefuroxime 1.5grams pre-operatively Repeated every 4 hours~Cefuroxime bolus-continuous infusion: Cefuroxime 1.5 grams pre-operatively, repeated 4 hourly during surgery."
11235796|NCT02445859|EG001|Reported Event|Interventional Regimen|"Cefuroxime continuous infusion targeting 64mg/l serum concentrations.~Cefuroxime 4 hourly bolus: Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L."
11235797|NCT02445911|BG000|Baseline|KQ-791 Dose 1|"Single loading dose of 100 mg on day 1, followed by single 50 mg doses on days 8, 15, 22, 29~KQ-791: Capsules administered orally"
11235798|NCT02445911|BG001|Baseline|KQ-791 Dose 2|"Single loading dose of 250 mg on day 1, followed by a daily dose of 25 mg for 28 days~KQ-791: Capsules administered orally"
11235799|NCT02445911|BG002|Baseline|KQ-791 Dose 3|"Single loading dose of 1500 mg on day 1, followed by a daily dose of 150 mg for 28 days~KQ-791: Capsules administered orally"
11235800|NCT02445911|BG003|Baseline|Placebo|"Multiple ascending doses matching KQ-791 dose~Placebo: Capsules administered orally"
11235801|NCT02445911|BG004|Baseline|Total|Total of all reporting groups
11235802|NCT02445911|FG000|Participant Flow|KQ-791 Dose 1|"Single loading dose of 100 mg on day 1, followed by single 50 mg doses on days 8, 15, 22, 29~KQ-791: Capsules administered orally"
11235803|NCT02445911|FG001|Participant Flow|KQ-791 Dose 2|"Single loading dose of 250 mg on day 1, followed by a daily dose of 25 mg for 28 days~KQ-791: Capsules administered orally"
11235804|NCT02445911|FG002|Participant Flow|KQ-791 Dose 3|"Single loading dose of 1500 mg on day 1, followed by a daily dose of 150 mg for 28 days~KQ-791: Capsules administered orally"
11235805|NCT02445911|FG003|Participant Flow|Placebo|"Multiple ascending doses matching KQ-791 dose~Placebo: Capsules administered orally"
11235806|NCT02445911|OG000|Outcome|KQ-791 Dose 1|"Single loading dose of 100 mg on day 1, followed by single 50 mg doses on days 8, 15, 22, 29~KQ-791: Capsules administered orally"
11235807|NCT02445911|OG001|Outcome|KQ-791 Dose 2|"Single loading dose of 250 mg on day 1, followed by a daily dose of 25 mg for 28 days~KQ-791: Capsules administered orally"
11235808|NCT02445911|OG002|Outcome|KQ-791 Dose 3|"Single loading dose of 1500 mg on day 1, followed by a daily dose of 150 mg for 28 days~KQ-791: Capsules administered orally"
11235809|NCT02445911|OG003|Outcome|Placebo|"Multiple ascending doses matching KQ-791 dose~Placebo: Capsules administered orally"
11235810|NCT02445911|EG000|Reported Event|KQ-791 Dose 1|"Single loading dose of 100 mg on day 1, followed by single 50 mg doses on days 8, 15, 22, 29~KQ-791: Capsules administered orally"
11183964|NCT02083926|OG001|Outcome|Saline Infusion on Day 0 or Day 28|A saline infusion was given on day 0 or day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.
11183965|NCT02083926|OG001|Outcome|Saline Infusion on Day 0 or Day 28|A saline infusion was given on day 0 or day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.
11183966|NCT02083926|EG000|Reported Event|Ketamine Infusion on Day 0 or Day 28|Participants were randomized to receive ketamine either on day 0 or on day 28. The ketamine infusion was given at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion.
11183967|NCT02083926|EG001|Reported Event|Saline Infusion on Day 0 or Day 28|Participants were randomized to receive a saline infusion either on day 0 or on day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion.
11183968|NCT02083965|BG000|Baseline|rFVIIIFc 1000 / 3000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator's discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
11183969|NCT02083965|BG001|Baseline|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator's discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
11183970|NCT02083965|BG002|Baseline|Total|Total of all reporting groups
11183971|NCT02083965|FG000|Participant Flow|rFVIIIFc 1000 / 3000|"Following a minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of pharmacokinetic (PK) assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator's discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
11183972|NCT02083965|FG001|Participant Flow|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator's discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
11183973|NCT02083965|OG000|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
11183974|NCT02083965|OG001|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
11183975|NCT02083965|OG001|Outcome|rFVIIIFc 3000 IU|rFVIIIFc single injection 50 IU/kg at a strength of 3000 IU/vial
11183976|NCT02083965|OG001|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
11183977|NCT02083965|OG000|Outcome|rFVIIIFc|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator's discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
11191417|NCT02132520|FG002|Participant Flow|Real rTMS + Real BCI Training|"Subjects will receive real rTMS followed by real BCI training.~rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.~BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen."
11191418|NCT02132520|OG000|Outcome|Sham rTMS + Real BCI Training|"Subjects will receive sham rTMS followed by real BCI training.~rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.~BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen."
11191419|NCT02132520|OG001|Outcome|Real rTMS + Real BCI Training|"Subjects will receive real rTMS followed by real BCI training.~rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.~BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen."
11191420|NCT02132520|EG000|Reported Event|Control|Subjects receiving standard-of-care physical therapy only.
11191421|NCT02132520|EG001|Reported Event|Sham rTMS + Real BCI Training|"Subjects will receive sham rTMS followed by real BCI training.~rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.~BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen."
11191422|NCT02132520|EG002|Reported Event|Real rTMS + Real BCI Training|"Subjects will receive real rTMS followed by real BCI training.~rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.~BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen."
11191423|NCT02132533|BG000|Baseline|Nifedipine|"Women with preterm labor will receive nifedipine.~Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.~Usual care: Usual evaluation, monitoring and care for women with preterm labor."
11191424|NCT02132533|BG001|Baseline|Placebo|"Women with preterm labor will receive placebo.~Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.~Usual care: Usual evaluation, monitoring and care for women with preterm labor."
11191425|NCT02132533|BG002|Baseline|Total|Total of all reporting groups
11191426|NCT02132533|FG000|Participant Flow|Nifedipine|"Women with preterm labor will receive nifedipine.~Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.~Usual care: Usual evaluation, monitoring and care for women with preterm labor."
11191427|NCT02132533|FG001|Participant Flow|Placebo|"Women with preterm labor will receive placebo.~Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.~Usual care: Usual evaluation, monitoring and care for women with preterm labor."
11191428|NCT02132533|OG000|Outcome|Nifedipine|"Women with preterm labor will receive nifedipine.~Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.~Usual care: Usual evaluation, monitoring and care for women with preterm labor."
11191429|NCT02132533|OG001|Outcome|Placebo|"Women with preterm labor will receive placebo.~Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.~Usual care: Usual evaluation, monitoring and care for women with preterm labor."
11191430|NCT02132533|EG000|Reported Event|Nifedipine|"Women with preterm labor will receive nifedipine.~Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.~Usual care: Usual evaluation, monitoring and care for women with preterm labor."
11191431|NCT02132533|EG001|Reported Event|Placebo|"Women with preterm labor will receive placebo.~Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.~Usual care: Usual evaluation, monitoring and care for women with preterm labor."
11191432|NCT02132572|BG000|Baseline|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
11191433|NCT02132572|FG000|Participant Flow|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
11191434|NCT02132572|OG000|Outcome|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
11191435|NCT02132572|EG000|Reported Event|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
11191436|NCT02132598|BG000|Baseline|Cabozantinib (XL184)|"Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)~Treatment until disease progression, death or unacceptable adverse events."
11191437|NCT02132598|FG000|Participant Flow|Cabozantinib (XL184)|"Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)~Treatment until disease progression, death or unacceptable adverse events."
11191438|NCT02132598|OG000|Outcome|Cabozantinib (XL184)|"Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)~Treatment until disease progression, death or unacceptable adverse events."
11191439|NCT02132598|EG000|Reported Event|Cabozantinib (XL184)|"Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)~Treatment until disease progression, death or unacceptable adverse events."
11191440|NCT02132637|BG000|Baseline|Insulin Peglispro/Insulin Glargine|"Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.~Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay."
11191441|NCT02132637|BG001|Baseline|Insulin Glargine/Insulin Peglispro|"Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.~Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay."
11191442|NCT02132637|BG002|Baseline|Total|Total of all reporting groups
11183978|NCT02083965|EG000|Reported Event|Total Active|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator's discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
11183979|NCT02084056|BG000|Baseline|FDC 2000 Fasted or L+M 2000 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 2000 fasted (T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 2000 fasted (R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
11183980|NCT02084056|BG001|Baseline|FDC 2000 Fed or L+M 2000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 2000 fed (T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after a high-fat, high-calorie meal.~L+M 2000 fed (R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
11183981|NCT02084056|BG002|Baseline|Total|Total of all reporting groups
11183982|NCT02084056|FG000|Participant Flow|FDC 2000 Fasted / L+M 2000 Fasted|"Linagliptin+ Metformin Fixed dose combination (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin Extended Release (XR) (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
11183983|NCT02084056|FG001|Participant Flow|L+M 2000 Fasted / FDC 2000 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
11183984|NCT02084056|FG002|Participant Flow|FDC 2000 Fed / L+M 2000 Fed|"Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
11183985|NCT02084056|FG003|Participant Flow|L+M 2000 Fed / FDC 2000 Fed|"Linagliptin+ Metformin-(R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
11183986|NCT02084056|OG000|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
11183987|NCT02084056|OG001|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
11183988|NCT02084056|OG002|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
11183989|NCT02084056|OG003|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
11183990|NCT02084056|EG000|Reported Event|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
11183991|NCT02084056|EG001|Reported Event|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
11183992|NCT02084056|EG002|Reported Event|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
11183993|NCT02084056|EG003|Reported Event|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
11183994|NCT02084069|BG000|Baseline|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
11183995|NCT02084069|BG001|Baseline|Control|Placebo
11183996|NCT02084069|BG002|Baseline|Total|Total of all reporting groups
11183997|NCT02084069|FG000|Participant Flow|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
11183998|NCT02084069|FG001|Participant Flow|Control|Placebo
11183999|NCT02084069|OG000|Outcome|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
11184000|NCT02084069|OG001|Outcome|Control|Placebo
11184001|NCT02084069|EG000|Reported Event|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
11184002|NCT02084069|EG001|Reported Event|Control|Placebo
11235811|NCT02445911|EG001|Reported Event|KQ-791 Dose 2|"Single loading dose of 250 mg on day 1, followed by a daily dose of 25 mg for 28 days~KQ-791: Capsules administered orally"
11235812|NCT02445911|EG002|Reported Event|KQ-791 Dose 3|"Single loading dose of 1500 mg on day 1, followed by a daily dose of 150 mg for 28 days~KQ-791: Capsules administered orally"
11235813|NCT02445911|EG003|Reported Event|Placebo|"Multiple ascending doses matching KQ-791 dose~Placebo: Capsules administered orally"
11235814|NCT02445963|BG000|Baseline|10 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235815|NCT02445963|BG001|Baseline|50 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235816|NCT02445963|BG002|Baseline|250 μg S. Flexneri 2a Invaplex|"10 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235817|NCT02445963|BG003|Baseline|500 μg S. Flexneri 2a Invaplex|"10 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235818|NCT02445963|BG004|Baseline|Total|Total of all reporting groups
11235819|NCT02445963|FG000|Participant Flow|10 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235820|NCT02445963|FG001|Participant Flow|50 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235821|NCT02445963|FG002|Participant Flow|250 μg S. Flexneri 2a Invaplex|"10 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235822|NCT02445963|FG003|Participant Flow|500 μg S. Flexneri 2a Invaplex|"10 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235823|NCT02445963|OG000|Outcome|10 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235824|NCT02445963|OG001|Outcome|50 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235825|NCT02445963|OG002|Outcome|250 μg S. Flexneri 2a Invaplex|"10 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235826|NCT02445963|OG003|Outcome|500 μg S. Flexneri 2a Invaplex|"10 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235827|NCT02445963|OG000|Outcome|10 μg S. Flexneri 2a Invaplex|"8 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235828|NCT02445963|OG002|Outcome|250 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235829|NCT02445963|EG000|Reported Event|10 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11184003|NCT02084082|BG000|Baseline|FDC 1000 Fast or L+M 1000 Fast|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 1000 fast (T fasted): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 1000 fast (R fasted): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
11184004|NCT02084082|BG001|Baseline|FDC 1000 Fed or L+M 1000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 1000 fed (T fed): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.~L+M 1000 fed (R fed): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
11184005|NCT02084082|BG002|Baseline|Total|Total of all reporting groups
11184006|NCT02084082|FG000|Participant Flow|FDC 1000 Fast/ L+M 1000 Fast|"Linagliptin/Metformin Extended Release (XR) Fixed dose combination (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
11184007|NCT02084082|FG001|Participant Flow|L+M1000 Fast/ FDC1000 Fast|"Single tablets of linagliptin and metformin Extended Release (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR Fixed Dose Combination (given as 1 FDC tablet), oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
11184008|NCT02084082|FG002|Participant Flow|FDC1000 Fed/L+M1000 Fed|"Linagliptin/Metformin XR FDC (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
11184009|NCT02084082|FG003|Participant Flow|L+M1000 Fed/ FDC1000 Fed|"Single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR FDC (given as 1 FDC tablet), oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
11184010|NCT02084082|OG000|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
11184011|NCT02084082|OG001|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
11184012|NCT02084082|OG002|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
11184013|NCT02084082|OG003|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
11184014|NCT02084082|EG000|Reported Event|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
11184015|NCT02084082|EG001|Reported Event|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
11184016|NCT02084082|EG002|Reported Event|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
11184017|NCT02084082|EG003|Reported Event|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
11184018|NCT02084134|BG000|Baseline|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
11184019|NCT02084134|BG001|Baseline|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
11184020|NCT02084134|BG002|Baseline|Total|Total of all reporting groups
11184021|NCT02084134|FG000|Participant Flow|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
11184022|NCT02084134|FG001|Participant Flow|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
11184023|NCT02084134|OG000|Outcome|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
11184024|NCT02084134|OG001|Outcome|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
11184025|NCT02084134|EG000|Reported Event|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
11184026|NCT02084134|EG001|Reported Event|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
11184027|NCT02084160|BG000|Baseline|CLD From HIS-EX-408/PLT-BID-1108|"Chronic liver disease subjects from previous Exalenz trial HIS-EX-408 and PLT-BID1108"
11184028|NCT02084160|FG000|Participant Flow|CLD From HIS-EX-408/PLT-BID-1108|"Chronic liver disease subjects from previous Exalenz trial HIS-EX-408 and PLT-BID1108"
11184029|NCT02084160|OG000|Outcome|CLD From HIS-EX-408/PLT-BID-1108|"Chronic liver disease subjects from previous Exalenz trial HIS-EX-408 and PLT-BID1108"
11184030|NCT02084160|EG000|Reported Event|CLD From HIS-EX-408/PLT-BID-1108|"Chronic liver disease subjects from previous Exalenz trial HIS-EX-408 and PLT-BID1108"
11184031|NCT02084238|BG000|Baseline|Interleukin-2|"Interleukin-2 to treat activated SLE.~Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease."
11184032|NCT02084238|FG000|Participant Flow|Interleukin-2|"Interleukin-2 to treat activated SLE.~Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day break, another cycle started) for 3-6 courses according to the situation of the disease."
11184033|NCT02084238|OG000|Outcome|SRI Results|All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).
11184034|NCT02084238|OG000|Outcome|Immunological Responses 1|Treg in total CD4+T cells in 23 patients with SLE
11184035|NCT02084238|OG001|Outcome|Immunological Responses 2|Tfh cells in CD4+ T cells in 23 patients with SLE
11184036|NCT02084238|OG002|Outcome|Immunological Responses 3|Th17 in CD4+T cells in 23 patients with SLE
11184037|NCT02084238|OG000|Outcome|Laboratory Variables 1|Serum complement 3 in SLE patients
11184038|NCT02084238|OG001|Outcome|Laboratory Variables 2|Serum complement 4 in SLE patients
11184039|NCT02084238|OG002|Outcome|Laboratory Variables 3|Serum anti-dsDNA antibodies in patients with SLE
11184040|NCT02084238|OG000|Outcome|SLEDAI Score|SLEDAI score at week 0 and week 10.
11184041|NCT02084238|EG000|Reported Event|IL-2 Therapy in SLE|All enrolled patients completed three cycles of recombinant human IL-2 (rhIL-2). In each cycle, 1 million IU rhIL-2 was administered subcutaneously every other day for 2 weeks, followed by a 2-week break.
11184042|NCT02084511|BG000|Baseline|BI 50 mg PfOS|This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
11184043|NCT02084511|BG001|Baseline|BI 200 mg PfOS|This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
11184044|NCT02084511|BG002|Baseline|Placebo|This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
11341438|NCT03682120|OG002|Outcome|15 mcg A/H7N9+MF59|15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11184045|NCT02084511|BG003|Baseline|Celecoxib 200 mg|This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
11184046|NCT02084511|BG004|Baseline|Total|Total of all reporting groups
11184047|NCT02084511|FG000|Participant Flow|BI 50 mg PfOS|This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
11184048|NCT02084511|FG001|Participant Flow|BI 200 mg PfOS|This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
11184049|NCT02084511|FG002|Participant Flow|Placebo|This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
11184050|NCT02084511|FG003|Participant Flow|Celecoxib 200 mg|This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
11184051|NCT02084511|OG000|Outcome|BI 50 mg PfOS|This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
11184052|NCT02084511|OG001|Outcome|BI 200 mg PfOS|This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
11184053|NCT02084511|OG002|Outcome|Placebo|This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
11184054|NCT02084511|OG003|Outcome|Celecoxib 200 mg|This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
11184055|NCT02084511|EG000|Reported Event|BI 50 mg PfOS|This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
11184056|NCT02084511|EG001|Reported Event|BI 200 mg PfOS|This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
11184057|NCT02084511|EG002|Reported Event|Placebo|This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
11184058|NCT02084511|EG003|Reported Event|Celecoxib 200 mg|This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
11184059|NCT02084628|BG000|Baseline|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
11184060|NCT02084628|FG000|Participant Flow|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participant to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
11184061|NCT02084628|OG000|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
11184062|NCT02084628|EG000|Reported Event|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
11184063|NCT02084706|BG000|Baseline|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
11184064|NCT02084706|BG001|Baseline|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
11184065|NCT02084706|BG002|Baseline|Total|Total of all reporting groups
11184066|NCT02084706|FG000|Participant Flow|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
11184067|NCT02084706|FG001|Participant Flow|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
11184068|NCT02084706|OG000|Outcome|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
11184069|NCT02084706|OG001|Outcome|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
11184070|NCT02084706|EG000|Reported Event|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
11184071|NCT02084706|EG001|Reported Event|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
11184072|NCT02084797|BG000|Baseline|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
11184073|NCT02084797|FG000|Participant Flow|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
11191443|NCT02132637|FG000|Participant Flow|Insulin Peglispro/Insulin Glargine|"Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.~Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay."
11191444|NCT02132637|FG001|Participant Flow|Insulin Glargine/Insulin Peglispro|"Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.~Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay."
11191445|NCT02132637|OG000|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
11191446|NCT02132637|OG001|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
11191447|NCT02132637|EG000|Reported Event|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
11191448|NCT02132637|EG001|Reported Event|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
11191449|NCT02132676|BG000|Baseline|Usual Care|Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
11191450|NCT02132676|BG001|Baseline|Active Treatment|All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
11191451|NCT02132676|BG002|Baseline|Total|Total of all reporting groups
11191452|NCT02132676|FG000|Participant Flow|Usual Care|Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
11191453|NCT02132676|FG001|Participant Flow|Active Treatment|All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
11191454|NCT02132676|OG000|Outcome|Usual Care|Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
11191455|NCT02132676|OG001|Outcome|Active Treatment|All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
11191456|NCT02132676|OG000|Outcome|Active Treatment|All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
11191457|NCT02132676|EG000|Reported Event|Usual Care|Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
11191458|NCT02132676|EG001|Reported Event|Active Treatment|All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
11191459|NCT02132754|BG000|Baseline|MK-4166 0.0015 mg|Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191460|NCT02132754|BG001|Baseline|MK-4166 0.0045 mg|Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191461|NCT02132754|BG002|Baseline|MK-4166 0.014 mg|Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191462|NCT02132754|BG003|Baseline|MK-4166 0.04 mg|Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191463|NCT02132754|BG004|Baseline|MK-4166 0.12 mg|Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191464|NCT02132754|BG005|Baseline|MK-4166 0.37 mg|Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191465|NCT02132754|BG006|Baseline|MK-4166 1.1 mg|Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191466|NCT02132754|BG007|Baseline|MK-4166 3.3 mg|Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191467|NCT02132754|BG008|Baseline|MK-4166 10 mg|Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191468|NCT02132754|BG009|Baseline|MK-4166 30 mg|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191469|NCT02132754|BG010|Baseline|MK-4166 42 mg|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191470|NCT02132754|BG011|Baseline|MK-4166 59 mg|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191471|NCT02132754|BG012|Baseline|MK-4166 82 mg|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191472|NCT02132754|BG013|Baseline|MK-4166 120 mg|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191473|NCT02132754|BG014|Baseline|MK-4166 170 mg|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191474|NCT02132754|BG015|Baseline|MK-4166 240 mg|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191475|NCT02132754|BG016|Baseline|MK-4166 340 mg|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191476|NCT02132754|BG017|Baseline|MK-4166 480 mg|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191477|NCT02132754|BG018|Baseline|MK-4166 670 mg|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191478|NCT02132754|BG019|Baseline|MK-4166 900 mg|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191479|NCT02132754|BG020|Baseline|MK-4166 1.1 mg + Pembro|Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191480|NCT02132754|BG021|Baseline|MK-4166 3.3 mg + Pembro|Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191481|NCT02132754|BG022|Baseline|MK-4166 10 mg + Pembro|Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191482|NCT02132754|BG023|Baseline|MK-4166 30 mg + Pembro|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11184074|NCT02084797|OG000|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
11184075|NCT02084797|EG000|Reported Event|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
11184076|NCT02085070|BG000|Baseline|Melanoma Patients|"After establishing eligibility criteria, for patients with melanoma the investigator will determine at least one lesion that requires local therapy (surgical resection or LITT) based on size, location, and/or risk of hemorrhage; this will be considered the surgical lesion. All other eligible brain lesions will be considered clinically evaluable lesions and will be followed by modified RECIST (mRECIST) criteria to determine best response.~MK-3475: IV MK-3475"
11184077|NCT02085070|BG001|Baseline|Non-small Cell Lung Cancer Patients|"NSCLC patients are not required to have a surgical lesion but must have at least one clinically evaluable lesion in the central nervous system. Patients on NSCLC are required to have formalin-fixed, paraffin-embedded tumor tissue available for biomarker analysis.~MK-3475: IV MK-3475"
11184078|NCT02085070|BG002|Baseline|Total|Total of all reporting groups
11184079|NCT02085070|FG000|Participant Flow|Melanoma Patients|"After establishing eligibility criteria, for patients with melanoma the investigator will determine at least one lesion that requires local therapy (surgical resection or LITT) based on size, location, and/or risk of hemorrhage; this will be considered the surgical lesion. All other eligible brain lesions will be considered clinically evaluable lesions and will be followed by modified RECIST (mRECIST) criteria to determine best response.~MK-3475: IV MK-3475"
11184080|NCT02085070|FG001|Participant Flow|Non-small Cell Lung Cancer Patients|"NSCLC patients are not required to have a surgical lesion but must have at least one clinically evaluable lesion in the central nervous system. Patients on NSCLC are required to have formalin-fixed, paraffin-embedded tumor tissue available for biomarker analysis.~MK-3475: IV MK-3475"
11184081|NCT02085070|OG000|Outcome|Melanoma Patients|"After establishing eligibility criteria, for patients with melanoma the investigator will determine at least one lesion that requires local therapy (surgical resection or LITT) based on size, location, and/or risk of hemorrhage; this will be considered the surgical lesion. All other eligible brain lesions will be considered clinically evaluable lesions and will be followed by modified RECIST (mRECIST) criteria to determine best response.~MK-3475: IV MK-3475"
11184082|NCT02085070|OG001|Outcome|Non-small Cell Lung Cancer Patients|"NSCLC patients are not required to have a surgical lesion but must have at least one clinically evaluable lesion in the central nervous system. Patients on NSCLC are required to have formalin-fixed, paraffin-embedded tumor tissue available for biomarker analysis.~MK-3475: IV MK-3475"
11184083|NCT02085070|EG000|Reported Event|Melanoma Patients|"After establishing eligibility criteria, for patients with melanoma the investigator will determine at least one lesion that requires local therapy (surgical resection or LITT) based on size, location, and/or risk of hemorrhage; this will be considered the surgical lesion. All other eligible brain lesions will be considered clinically evaluable lesions and will be followed by modified RECIST (mRECIST) criteria to determine best response.~MK-3475: IV MK-3475"
11184084|NCT02085070|EG001|Reported Event|Non-small Cell Lung Cancer Patients|"NSCLC patients are not required to have a surgical lesion but must have at least one clinically evaluable lesion in the central nervous system. Patients on NSCLC are required to have formalin-fixed, paraffin-embedded tumor tissue available for biomarker analysis.~MK-3475: IV MK-3475"
11184085|NCT02085135|BG000|Baseline|1-Week Titration|ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
11184086|NCT02085135|BG001|Baseline|2-Week Titration|ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
11184087|NCT02085135|BG002|Baseline|Total|Total of all reporting groups
11184088|NCT02085135|FG000|Participant Flow|1-Week Titration|ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
11184089|NCT02085135|FG001|Participant Flow|2-Week Titration|ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
11184090|NCT02085135|OG000|Outcome|1-Week Titration|ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
11184091|NCT02085135|OG001|Outcome|2-Week Titration|ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
11184092|NCT02085135|EG000|Reported Event|1-Week Titration|ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
11184093|NCT02085135|EG001|Reported Event|2-Week Titration|ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
11184094|NCT02085161|BG000|Baseline|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184095|NCT02085161|BG001|Baseline|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184096|NCT02085161|BG002|Baseline|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184097|NCT02085161|BG003|Baseline|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
11184098|NCT02085161|BG004|Baseline|Total|Total of all reporting groups
11184099|NCT02085161|FG000|Participant Flow|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184100|NCT02085161|FG001|Participant Flow|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184101|NCT02085161|FG002|Participant Flow|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184102|NCT02085161|FG003|Participant Flow|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
11184103|NCT02085161|OG000|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184104|NCT02085161|OG001|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184105|NCT02085161|OG002|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184106|NCT02085161|OG003|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
11184107|NCT02085161|EG000|Reported Event|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184108|NCT02085161|EG001|Reported Event|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184109|NCT02085161|EG002|Reported Event|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
11184110|NCT02085161|EG003|Reported Event|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
11184111|NCT02085161|EG004|Reported Event|Total|Total
11184112|NCT02085252|BG000|Baseline|Leuprorelin 11.25 mg|Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.
11184113|NCT02085252|BG001|Baseline|Active Surveillance|Active surveillance is close medical monitoring of prostate cancer for any changes.
11184114|NCT02085252|BG002|Baseline|Total|Total of all reporting groups
11184115|NCT02085252|FG000|Participant Flow|Leuprorelin 11.25 mg|Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.
11184116|NCT02085252|FG001|Participant Flow|Active Surveillance|Active surveillance is close medical monitoring of prostate cancer for any changes.
11184117|NCT02085252|OG000|Outcome|Leuprorelin 11.25 mg|Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.
11184118|NCT02085252|OG001|Outcome|Active Surveillance|Active surveillance is close medical monitoring of prostate cancer for any changes.
11184119|NCT02085252|EG000|Reported Event|Leuprorelin 11.25 mg|Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.
11184120|NCT02085252|EG001|Reported Event|Active Surveillance|Active surveillance is close medical monitoring of prostate cancer for any changes.
11184121|NCT02085356|BG000|Baseline|Intervention Women With Partners|"Women will enroll with male partners and both members of the couple will attend the Protect your Family intervention~Protect your family: Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
11184122|NCT02085356|BG001|Baseline|Intervention Women Without Partners|"Women will enroll alone and will attend the Protect your Family Intervention without a partner~Protect your family: Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
11184123|NCT02085356|BG002|Baseline|Control Women With Partners|Women will enroll with male partners and both members of the couple will attend time-matched video sessions
11184124|NCT02085356|BG003|Baseline|Control Women Alone|Women will enroll alone and will attend time-matched video sessions
11184125|NCT02085356|BG004|Baseline|Total|Total of all reporting groups
11191483|NCT02132754|BG024|Baseline|MK-4166 42 mg + Pembro|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191484|NCT02132754|BG025|Baseline|MK-4166 59 mg + Pembro|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191485|NCT02132754|BG026|Baseline|MK-4166 82 mg + Pembro|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191486|NCT02132754|BG027|Baseline|MK-4166 120 mg + Pembro|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191487|NCT02132754|BG028|Baseline|MK-4166 170 mg + Pembro|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191488|NCT02132754|BG029|Baseline|MK-4166 240 mg + Pembro|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191489|NCT02132754|BG030|Baseline|MK-4166 340 mg + Pembro|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191490|NCT02132754|BG031|Baseline|MK-4166 480 mg + Pembro|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191491|NCT02132754|BG032|Baseline|MK-4166 670 mg + Pembro|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191492|NCT02132754|BG033|Baseline|MK-4166 900 mg + Pembro|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191493|NCT02132754|BG034|Baseline|Total|Total of all reporting groups
11191494|NCT02132754|FG000|Participant Flow|MK-4166 0.0015 mg|Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191495|NCT02132754|FG001|Participant Flow|MK-4166 0.0045 mg|Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191496|NCT02132754|FG002|Participant Flow|MK-4166 0.014 mg|Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191497|NCT02132754|FG003|Participant Flow|MK-4166 0.04 mg|Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191498|NCT02132754|FG004|Participant Flow|MK-4166 0.12 mg|Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191499|NCT02132754|FG005|Participant Flow|MK-4166 0.37 mg|Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191500|NCT02132754|FG006|Participant Flow|MK-4166 1.1 mg|Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191501|NCT02132754|FG007|Participant Flow|MK-4166 3.3 mg|Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191502|NCT02132754|FG008|Participant Flow|MK-4166 10 mg|Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191503|NCT02132754|FG009|Participant Flow|MK-4166 30 mg|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191504|NCT02132754|FG010|Participant Flow|MK-4166 42 mg|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191505|NCT02132754|FG011|Participant Flow|MK-4166 59 mg|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191506|NCT02132754|FG012|Participant Flow|MK-4166 82 mg|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191507|NCT02132754|FG013|Participant Flow|MK-4166 120 mg|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191508|NCT02132754|FG014|Participant Flow|MK-4166 170 mg|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191509|NCT02132754|FG015|Participant Flow|MK-4166 240 mg|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191510|NCT02132754|FG016|Participant Flow|MK-4166 340 mg|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191511|NCT02132754|FG017|Participant Flow|MK-4166 480 mg|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191512|NCT02132754|FG018|Participant Flow|MK-4166 670 mg|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191513|NCT02132754|FG019|Participant Flow|MK-4166 900 mg|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191514|NCT02132754|FG020|Participant Flow|MK-4166 1.1 mg + Pembro|Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191515|NCT02132754|FG021|Participant Flow|MK-4166 3.3 mg + Pembro|Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191516|NCT02132754|FG022|Participant Flow|MK-4166 10 mg + Pembro|Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191517|NCT02132754|FG023|Participant Flow|MK-4166 30 mg + Pembro|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191518|NCT02132754|FG024|Participant Flow|MK-4166 42 mg + Pembro|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11184126|NCT02085356|FG000|Participant Flow|Intervention Women With Partners|"Women will enroll with male partners and both members of the couple will attend the Protect your Family intervention~Protect your family: Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
11184127|NCT02085356|FG001|Participant Flow|Intervention Women Without Partners|"Women will enroll alone and will attend the Protect your Family Intervention without a partner~Protect your family: Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
11184128|NCT02085356|FG002|Participant Flow|Control Women With Partners|Women will enroll with male partners and both members of the couple will attend time-matched video sessions
11184129|NCT02085356|FG003|Participant Flow|Control Women Alone|Women will enroll alone and will attend time-matched video sessions
11184130|NCT02085356|OG000|Outcome|Intervention Women With Partners|"Women will enroll with male partners and both members of the couple will attend the Protect your Family intervention~Protect your family: Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
11184131|NCT02085356|OG001|Outcome|Intervention Women Without Partners|"Women will enroll alone and will attend the Protect your Family Intervention without a partner~Protect your family: Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
11184132|NCT02085356|OG002|Outcome|Control Women With Partners|Women will enroll with male partners and both members of the couple will attend time-matched video sessions
11184133|NCT02085356|OG003|Outcome|Control Women Alone|Women will enroll alone and will attend time-matched video sessions
11184134|NCT02085356|EG000|Reported Event|Intervention Women With Partners|"Women will enroll with male partners and both members of the couple will attend the Protect your Family intervention~Protect your family: Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
11184135|NCT02085356|EG001|Reported Event|Intervention Women Without Partners|"Women will enroll alone and will attend the Protect your Family Intervention without a partner~Protect your family: Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
11184136|NCT02085356|EG002|Reported Event|Control Women With Partners|Women will enroll with male partners and both members of the couple will attend time-matched video sessions
11184137|NCT02085356|EG003|Reported Event|Control Women Alone|Women will enroll alone and will attend time-matched video sessions
11191519|NCT02132754|FG025|Participant Flow|MK-4166 59 mg + Pembro|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11184138|NCT02085447|BG000|Baseline|CAE-L|"Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.~CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end."
11184139|NCT02085447|FG000|Participant Flow|CAE-L|"Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.~CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end."
11184140|NCT02085447|OG000|Outcome|CAE-L|"Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.~CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end."
11184141|NCT02085447|OG000|Outcome|CAE-L|"Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.~CAE-L (Customized Adherence Enhancement- Long-acting injectable): Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end."
11184142|NCT02085447|EG000|Reported Event|CAE-L|"Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.~CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end."
11184143|NCT02085460|BG000|Baseline|2% Rebamipide Liquid|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184144|NCT02085460|BG001|Baseline|4% Rebamipide Liquid|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184145|NCT02085460|BG002|Baseline|Placebo|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184146|NCT02085460|BG003|Baseline|Total|Total of all reporting groups
11184147|NCT02085460|FG000|Participant Flow|2% Rebamipide Liquid|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184148|NCT02085460|FG001|Participant Flow|4% Rebamipide Liquid|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184149|NCT02085460|FG002|Participant Flow|Placebo|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184150|NCT02085460|OG000|Outcome|2% Rebamipide Liquid|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184151|NCT02085460|OG001|Outcome|4% Rebamipide Liquid|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184152|NCT02085460|OG002|Outcome|Placebo|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184153|NCT02085460|EG000|Reported Event|2% Rebamipide Liquid|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184154|NCT02085460|EG001|Reported Event|4% Rebamipide Liquid|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184155|NCT02085460|EG002|Reported Event|Placebo|6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)
11184156|NCT02085473|BG000|Baseline|Cohort 1|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
11184157|NCT02085473|BG001|Baseline|Cohort 2|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
11184158|NCT02085473|BG002|Baseline|Cohort 3|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
11184159|NCT02085473|BG003|Baseline|Cohort 4|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
11184160|NCT02085473|BG004|Baseline|Total|Total of all reporting groups
11184161|NCT02085473|FG000|Participant Flow|Cohort 1|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
11184162|NCT02085473|FG001|Participant Flow|Cohort 2|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
11184163|NCT02085473|FG002|Participant Flow|Cohort 3|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
11184164|NCT02085473|FG003|Participant Flow|Cohort 4|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
11184165|NCT02085473|OG000|Outcome|Cohort 1|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
11184166|NCT02085473|OG001|Outcome|Cohort 2|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
11184167|NCT02085473|OG002|Outcome|Cohort 3|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
11184168|NCT02085473|OG003|Outcome|Cohort 4|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
11184169|NCT02085473|EG000|Reported Event|Cohort 1|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
11184170|NCT02085473|EG001|Reported Event|Cohort 2|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
11184171|NCT02085473|EG002|Reported Event|Cohort 3|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
11184172|NCT02085473|EG003|Reported Event|Cohort 4|Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
11184173|NCT02085551|BG000|Baseline|Mechanical Thrombectomy by the Indigo System|Mechanical Thrombectomy by the Indigo System
11184174|NCT02085551|FG000|Participant Flow|Mechanical Thrombectomy by the Indigo System|Mechanical Thrombectomy by the Indigo System
11184175|NCT02085551|OG000|Outcome|Mechanical Thrombectomy by the Indigo System|Mechanical Thrombectomy by the Indigo System
11184176|NCT02085551|EG000|Reported Event|Mechanical Thrombectomy by the Indigo System|Mechanical Thrombectomy by the Indigo System
11184177|NCT02085720|BG000|Baseline|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
11184178|NCT02085720|FG000|Participant Flow|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.~CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
11184179|NCT02085720|OG000|Outcome|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.~CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
11184180|NCT02085720|OG000|Outcome|Chinese Elderly OSAS|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.
11184181|NCT02085720|OG000|Outcome|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
11191520|NCT02132754|FG026|Participant Flow|MK-4166 82 mg + Pembro|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191521|NCT02132754|FG027|Participant Flow|MK-4166 120 mg + Pembro|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11184182|NCT02085720|OG000|Outcome|AHI Result|Subjects who had completed the questionnaires and consented for sleep study were invited to undergo a portable at-home sleep study. In the afternoon, subjects attended the pulmonary function laboratory to be fitted with the EmblettaTM portable diagnostic system (PDS, Medcare, Iceland). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an AHI based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. Respiratory events were scored when desaturations of at least 4% occurred in the absence of moving artifacts and irrespective of co-existing changes in snoring or heart rate. A hypopnea was defined as a decrease in airflow by 50% of baseline for at least 10 seconds. Data were included in the analysis if the total recorded evaluation time of 4 hrs or longer was obtained during the EmblettaTM PDS study.
11184183|NCT02085720|OG000|Outcome|Sleep Heatlh Questionnaire Result|We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres.
11184184|NCT02085720|EG000|Reported Event|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
11184185|NCT02085785|BG000|Baseline|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
11184186|NCT02085785|BG001|Baseline|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
11184187|NCT02085785|BG002|Baseline|Total|Total of all reporting groups
11184188|NCT02085785|FG000|Participant Flow|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
11184189|NCT02085785|FG001|Participant Flow|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
11184190|NCT02085785|OG000|Outcome|Overall Study Feasibility|Reporting of recruitment and eligibility for the targeted population
11184191|NCT02085785|OG000|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
11184192|NCT02085785|OG001|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
11184193|NCT02085785|OG000|Outcome|Self-directed + Coached Combined|Intervention assessment questionnaires were not linked to other study data, so we are unable to report study group information
11235830|NCT02445963|EG001|Reported Event|50 μg S. Flexneri 2a Invaplex|"9 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235831|NCT02445963|EG002|Reported Event|250 μg S. Flexneri 2a Invaplex|"10 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235832|NCT02445963|EG003|Reported Event|500 μg S. Flexneri 2a Invaplex|"10 subjects vaccinated on days 0, 14, 28~Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot."
11235833|NCT02446015|BG000|Baseline|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
11235834|NCT02446015|BG001|Baseline|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
11235835|NCT02446015|BG002|Baseline|Total|Total of all reporting groups
11235836|NCT02446015|FG000|Participant Flow|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days
11235837|NCT02446015|FG001|Participant Flow|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
11235838|NCT02446015|OG000|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
11235839|NCT02446015|OG001|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
11235840|NCT02446015|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11235841|NCT02446015|EG001|Reported Event|Systane Ultra QID|All subjects treated with SYSTANE® ULTRA lubricant eye drops QID
11235842|NCT02446015|EG002|Reported Event|Systane Ultra PRN|All subjects treated with SYSTANE® ULTRA lubricant eye drops PRN
11235843|NCT02446171|BG000|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
11235844|NCT02446171|BG001|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
11235845|NCT02446171|BG002|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
11235846|NCT02446171|BG003|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
11235847|NCT02446171|BG004|Baseline|Total|Total of all reporting groups
11235848|NCT02446171|FG000|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
11235849|NCT02446171|FG001|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
11235850|NCT02446171|FG002|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
11235851|NCT02446171|FG003|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
11235852|NCT02446171|OG000|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
11235853|NCT02446171|OG001|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
11235854|NCT02446171|OG002|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
11235855|NCT02446171|OG003|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
11235856|NCT02446171|OG000|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
11235857|NCT02446171|OG001|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
11235858|NCT02446171|EG000|Reported Event|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
11235859|NCT02446171|EG001|Reported Event|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
11235860|NCT02446171|EG002|Reported Event|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
11235861|NCT02446171|EG003|Reported Event|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
11235862|NCT02446223|BG000|Baseline|Active|Inggenol Mebutate 0.015%
11235863|NCT02446223|FG000|Participant Flow|Active Inggenol Mebutate|Inggenol Mebutate 0.015%
11235864|NCT02446223|OG000|Outcome|Active|Inggenol Mebutate 0.015%
11235865|NCT02446223|EG000|Reported Event|Active|Inggenol Mebutate 0.015%
11235866|NCT02446314|BG000|Baseline|Placebo|Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
11235867|NCT02446314|BG001|Baseline|Wild Blueberry Powder - 450mg|Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
11235868|NCT02446314|BG002|Baseline|Wild Blueberry Powder - 900 mg|Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
11235869|NCT02446314|BG003|Baseline|Wild Blueberry Extract 100mg|Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
11235870|NCT02446314|BG004|Baseline|Total|Total of all reporting groups
11235871|NCT02446314|FG000|Participant Flow|Placebo|"Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen~Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen"
11341439|NCT03682120|OG003|Outcome|15 mcg A/H7N9|15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11191522|NCT02132754|FG028|Participant Flow|MK-4166 170 mg + Pembro|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191523|NCT02132754|FG029|Participant Flow|MK-4166 240 mg + Pembro|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191524|NCT02132754|FG030|Participant Flow|MK-4166 340 mg + Pembro|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191525|NCT02132754|FG031|Participant Flow|MK-4166 480 mg + Pembro|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191526|NCT02132754|FG032|Participant Flow|MK-4166 670 mg + Pembro|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191527|NCT02132754|FG033|Participant Flow|MK-4166 900 mg + Pembro|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191528|NCT02132754|OG000|Outcome|MK-4166 0.0015 mg|Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191529|NCT02132754|OG001|Outcome|MK-4166 0.0045 mg|Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191530|NCT02132754|OG002|Outcome|MK-4166 0.014 mg|Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191531|NCT02132754|OG003|Outcome|MK-4166 0.04 mg|Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191532|NCT02132754|OG004|Outcome|MK-4166 0.12 mg|Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191533|NCT02132754|OG005|Outcome|MK-4166 0.37 mg|Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191534|NCT02132754|OG006|Outcome|MK-4166 1.1 mg|Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191535|NCT02132754|OG007|Outcome|MK-4166 3.3 mg|Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191536|NCT02132754|OG008|Outcome|MK-4166 10 mg|Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191537|NCT02132754|OG009|Outcome|MK-4166 30 mg|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191538|NCT02132754|OG010|Outcome|MK-4166 42 mg|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191539|NCT02132754|OG011|Outcome|MK-4166 59 mg|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191540|NCT02132754|OG012|Outcome|MK-4166 82 mg|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191541|NCT02132754|OG013|Outcome|MK-4166 120 mg|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191542|NCT02132754|OG014|Outcome|MK-4166 170 mg|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191543|NCT02132754|OG015|Outcome|MK-4166 240 mg|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191544|NCT02132754|OG016|Outcome|MK-4166 340 mg|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191545|NCT02132754|OG017|Outcome|MK-4166 480 mg|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191546|NCT02132754|OG018|Outcome|MK-4166 670 mg|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191547|NCT02132754|OG019|Outcome|MK-4166 900 mg|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191548|NCT02132754|OG020|Outcome|MK-4166 1.1 mg + Pembro|Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191549|NCT02132754|OG021|Outcome|MK-4166 3.3 mg + Pembro|Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191550|NCT02132754|OG022|Outcome|MK-4166 10 mg + Pembro|Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191551|NCT02132754|OG023|Outcome|MK-4166 30 mg + Pembro|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191552|NCT02132754|OG024|Outcome|MK-4166 42 mg + Pembro|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191553|NCT02132754|OG025|Outcome|MK-4166 59 mg + Pembro|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191554|NCT02132754|OG026|Outcome|MK-4166 82 mg + Pembro|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191555|NCT02132754|OG027|Outcome|MK-4166 120 mg + Pembro|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191556|NCT02132754|OG028|Outcome|MK-4166 170 mg + Pembro|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191557|NCT02132754|OG029|Outcome|MK-4166 240 mg + Pembro|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191558|NCT02132754|OG030|Outcome|MK-4166 340 mg + Pembro|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11184194|NCT02085785|EG000|Reported Event|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
11184195|NCT02085785|EG001|Reported Event|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
11184196|NCT02085980|BG000|Baseline|Laser Treatment|"Laser Treatment~Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece"
11184197|NCT02085980|FG000|Participant Flow|Laser Treatment|"Laser Treatment~Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece"
11184198|NCT02085980|OG000|Outcome|Laser Treatment|"Laser Treatment~Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece"
11184199|NCT02085980|EG000|Reported Event|Laser Treatment|"Laser Treatment~Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece"
11184200|NCT02086110|BG000|Baseline|Prebiotic Only First, Then Synbiotic|This group will receive prebiotic only (bovine milk oligosaccharides, administered orally twice per day for a daily total of 0.3 g per pound of body weight) for the first five weeks, followed by a two week break with no treatment, and then will receive the synbiotic (Bifidobacterium infantis (10 billion CFU) twice a day plus 0.3 g per pound body weight of bovine milk oligosaccharides in two divided doses per day orally) for the next five weeks.
11184201|NCT02086110|BG001|Baseline|Synbiotic First, Then Prebiotic Only|This group will receive the synbiotic (Bifidobacterium infantis (10 billion CFU) twice a day plus 0.3 g per pound body weight of bovine milk oligosaccharides in two divided doses per day orally) for the first five weeks, followed by a two week break with no treatment, and then will receive the prebiotic only (bovine milk oligosacharrides, administered orally twice per day for a daily total of 0.3 g per pound of body weight) for the next five weeks.
11184202|NCT02086110|BG002|Baseline|Total|Total of all reporting groups
11184203|NCT02086110|FG000|Participant Flow|Prebiotic Only First, Then Synbiotic|This group will receive prebiotic only (bovine milk oligosaccharides, administered orally twice per day for a daily total of 0.3 g per pound of body weight) for the first five weeks, followed by a two week break with no treatment, and then will receive the synbiotic (Bifidobacterium infantis (10 billion CFU) twice a day plus 0.3 g per pound body weight of bovine milk oligosaccharides in two divided doses per day orally) for the next five weeks.
11184204|NCT02086110|FG001|Participant Flow|Synbiotic First, Then Prebiotic Only|This group will receive the synbiotic (Bifidobacterium infantis (10 billion CFU) twice a day plus 0.3 g per pound body weight of bovine milk oligosaccharides in two divided doses per day orally) for the first five weeks, followed by a two week break with no treatment, and then will receive the prebiotic only (bovine milk oligosacharrides, administered orally twice per day for a daily total of 0.3 g per pound of body weight) for the next five weeks.
11184205|NCT02086110|OG000|Outcome|Prebiotic Only First, Then Synbiotic|This group will receive prebiotic only (bovine milk oligosaccharides, administered orally twice per day for a daily total of 0.3 g per pound of body weight) for the first five weeks, followed by a two week break with no treatment, and then will receive the synbiotic (Bifidobacterium infantis (10 billion CFU) twice a day plus 0.3 g per pound body weight of bovine milk oligosaccharides in two divided doses per day orally) for the next five weeks.
11184206|NCT02086110|OG001|Outcome|Synbiotic First, Then Prebiotic Only|This group will receive the synbiotic (Bifidobacterium infantis (10 billion CFU) twice a day plus 0.3 g per pound body weight of bovine milk oligosaccharides in two divided doses per day orally) for the first five weeks, followed by a two week break with no treatment, and then will receive the prebiotic only (bovine milk oligosacharrides, administered orally twice per day for a daily total of 0.3 g per pound of body weight) for the next five weeks.
11184207|NCT02086110|OG000|Outcome|All Subjects|All subjects with serum samples available for analysis were included below.
11184208|NCT02086110|EG000|Reported Event|Prebiotic Only Arm|Includes reported adverse events for all subjects while receiving prebiotic only (bovine milk oligosaccharides, administered orally twice per day for a daily total of 0.3 g per pound of body weight).
11184209|NCT02086110|EG001|Reported Event|Synbiotic Arm|Includes reported adverse events for all subjects while receiving the synbiotic (Bifidobacterium infantis (10 billion CFU) twice a day plus 0.3 g per pound body weight of bovine milk oligosaccharides in two divided doses per day orally).
11184210|NCT02086162|BG000|Baseline|Behavioral Intervention|Web-based motivational decision support system
11184211|NCT02086162|BG001|Baseline|Educational Intervention|"Computerized version of the National Cancer Institute (NCI) Educational Pamphlet~NCI Education"
11184212|NCT02086162|BG002|Baseline|Total|Total of all reporting groups
11184213|NCT02086162|FG000|Participant Flow|Let's Talk About Smoking|These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior [98], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) [140, 141]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment [142-144], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.
11235872|NCT02446314|FG001|Participant Flow|Wild Blueberry Powder - 450mg|"Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen~Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen"
11235873|NCT02446314|FG002|Participant Flow|Wild Blueberry Powder - 900 mg|"Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen~Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen"
11235874|NCT02446314|FG003|Participant Flow|Wild Blueberry Extract 100mg|"Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen~Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen"
11235875|NCT02446314|OG000|Outcome|Placebo|"Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen~Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen"
11235876|NCT02446314|OG001|Outcome|Wild Blueberry Powder - 450mg|"Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen~Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen"
11235877|NCT02446314|OG002|Outcome|Wild Blueberry Powder - 900 mg|"Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen~Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen"
11235878|NCT02446314|OG003|Outcome|Wild Blueberry Extract 100mg|"Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen~Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen"
11235879|NCT02446314|OG000|Outcome|Placebo|Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
11235880|NCT02446314|OG001|Outcome|Wild Blueberry Powder - 450mg|Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
11235881|NCT02446314|OG002|Outcome|Wild Blueberry Powder - 900 mg|Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
11235882|NCT02446314|OG003|Outcome|Wild Blueberry Extract 100mg|Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
11235883|NCT02446314|EG000|Reported Event|Placebo|Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
11235884|NCT02446314|EG001|Reported Event|Wild Blueberry Powder - 500mg|Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
11235885|NCT02446314|EG002|Reported Event|Wild Blueberry Powder - 1000 mg|Wild Blueberry Powder - 1000 mg: Formulation containing 900 mg wild blueberry powder + 90 mg L-Cysteine + 10 mg L-Glutathione once daily, in a 2-hard capsule regimen
11235886|NCT02446314|EG003|Reported Event|Wild Blueberry Extract 111mg|Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 889 mg of placebo, once daily, in a 2-hard capsule regimen
11235887|NCT02446418|BG000|Baseline|Usual ICS/LABA|Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.
11235888|NCT02446418|BG001|Baseline|FF/VI|Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
11235889|NCT02446418|BG002|Baseline|Total|Total of all reporting groups
11235890|NCT02446418|FG000|Participant Flow|Usual ICS/LABA|Eligible participants received fixed combination inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) (Fluticasone propionate [FP]/ Salmeterol [S] 250/50 micrograms [mcg] or 500/50 mcg, 1 inhalation twice daily; or Budesonide [BUD]/ Formoterol [F] 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.
11235891|NCT02446418|FG001|Participant Flow|FF/VI|Eligible participants received Fluticasone Furoate (FF)/ Vilanterol (VI) 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
11235892|NCT02446418|OG000|Outcome|Usual ICS/LABA|Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.
11235893|NCT02446418|OG001|Outcome|FF/VI|Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
11235894|NCT02446418|EG000|Reported Event|Usual ICS/LABA|Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.
11235895|NCT02446418|EG001|Reported Event|FF/VI|Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
11235896|NCT02446483|BG000|Baseline|Treatment A-rabeprazole 20 mg + Treatment B-rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 20 mg enteric coated tablet) or treatment B (rabeprazole 20 mg gastro-resistant tablet), given with 240 mL water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
11191559|NCT02132754|OG031|Outcome|MK-4166 480 mg + Pembro|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191560|NCT02132754|OG032|Outcome|MK-4166 670 mg + Pembro|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191561|NCT02132754|OG033|Outcome|MK-4166 900 mg + Pembro|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191562|NCT02132754|OG000|Outcome|MK-4166 Monotherapy|Participants received assigned dose of MK-4166 IV on Day 1 of each 21-day cycle, for up to 4 cycles.
11191563|NCT02132754|OG001|Outcome|MK-4166 + Pembro Combination Therapy|Participants received assigned dose of MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191564|NCT02132754|OG002|Outcome|MK-4166 0.0015 mg|Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191565|NCT02132754|OG003|Outcome|MK-4166 0.0045 mg|Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191566|NCT02132754|OG004|Outcome|MK-4166 0.014 mg|Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191567|NCT02132754|OG005|Outcome|MK-4166 0.04 mg|Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191568|NCT02132754|OG006|Outcome|MK-4166 0.12 mg|Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191569|NCT02132754|OG007|Outcome|MK-4166 0.37 mg|Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191570|NCT02132754|OG008|Outcome|MK-4166 1.1 mg|Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191571|NCT02132754|OG009|Outcome|MK-4166 3.3 mg|Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191572|NCT02132754|OG010|Outcome|MK-4166 10 mg|Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191573|NCT02132754|OG011|Outcome|MK-4166 30 mg|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191574|NCT02132754|OG012|Outcome|MK-4166 42 mg|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191575|NCT02132754|OG013|Outcome|MK-4166 59 mg|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191576|NCT02132754|OG014|Outcome|MK-4166 82 mg|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191577|NCT02132754|OG015|Outcome|MK-4166 120 mg|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191578|NCT02132754|OG016|Outcome|MK-4166 170 mg|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191579|NCT02132754|OG017|Outcome|MK-4166 240 mg|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191580|NCT02132754|OG018|Outcome|MK-4166 340 mg|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191581|NCT02132754|OG019|Outcome|MK-4166 480 mg|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191582|NCT02132754|OG020|Outcome|MK-4166 670 mg|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191583|NCT02132754|OG021|Outcome|MK-4166 900 mg|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191584|NCT02132754|OG022|Outcome|MK-4166 1.1 mg + Pembro|Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191585|NCT02132754|OG023|Outcome|MK-4166 3.3 mg + Pembro|Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191586|NCT02132754|OG024|Outcome|MK-4166 10 mg + Pembro|Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191587|NCT02132754|OG025|Outcome|MK-4166 30 mg + Pembro|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191588|NCT02132754|OG026|Outcome|MK-4166 42 mg + Pembro|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191589|NCT02132754|OG027|Outcome|MK-4166 59 mg + Pembro|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191590|NCT02132754|OG028|Outcome|MK-4166 82 mg + Pembro|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191591|NCT02132754|OG029|Outcome|MK-4166 120 mg + Pembro|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191592|NCT02132754|OG030|Outcome|MK-4166 170 mg + Pembro|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191593|NCT02132754|OG031|Outcome|MK-4166 240 mg + Pembro|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191594|NCT02132754|OG032|Outcome|MK-4166 340 mg + Pembro|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191595|NCT02132754|OG033|Outcome|MK-4166 480 mg + Pembro|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191596|NCT02132754|OG034|Outcome|MK-4166 670 mg + Pembro|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191597|NCT02132754|OG035|Outcome|MK-4166 900 mg + Pembro|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191598|NCT02132754|OG007|Outcome|MK-4166 3.3 mg|Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191599|NCT02132754|OG018|Outcome|MK-4166 670 mg|Participant received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191600|NCT02132754|EG000|Reported Event|MK-4166|All participants that received MK-4166 IV on Day 1 of each 21-day cycle, for up to 4 cycles (according to assigned dose).
11191601|NCT02132754|EG001|Reported Event|MK-4166 + Pembro|All participants that received MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles (according to assigned dose) plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles (according to assigned doses).
11191602|NCT02132754|EG002|Reported Event|MK-4166 0.0015 mg|Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191603|NCT02132754|EG003|Reported Event|MK-4166 0.0045 mg|Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191604|NCT02132754|EG004|Reported Event|MK-4166 0.014 mg|Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191605|NCT02132754|EG005|Reported Event|MK-4166 0.04 mg|Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191606|NCT02132754|EG006|Reported Event|MK-4166 0.12 mg|Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191607|NCT02132754|EG007|Reported Event|MK-4166 0.37 mg|Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191608|NCT02132754|EG008|Reported Event|MK-4166 1.1 mg|Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191609|NCT02132754|EG009|Reported Event|MK-4166 3.3 mg|Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191610|NCT02132754|EG010|Reported Event|MK-4166 10 mg|Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191611|NCT02132754|EG011|Reported Event|MK-4166 30 mg|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191612|NCT02132754|EG012|Reported Event|MK-4166 42 mg|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191613|NCT02132754|EG013|Reported Event|MK-4166 59 mg|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191614|NCT02132754|EG014|Reported Event|MK-4166 82 mg|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191615|NCT02132754|EG015|Reported Event|MK-4166 120 mg|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191616|NCT02132754|EG016|Reported Event|MK-4166 170 mg|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191617|NCT02132754|EG017|Reported Event|MK-4166 240 mg|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191618|NCT02132754|EG018|Reported Event|MK-4166 340 mg|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191619|NCT02132754|EG019|Reported Event|MK-4166 480 mg|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191620|NCT02132754|EG020|Reported Event|MK-4166 670 mg|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191621|NCT02132754|EG021|Reported Event|MK-4166 900 mg|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
11191622|NCT02132754|EG022|Reported Event|MK-4166 1.1 mg + Pembro|Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191623|NCT02132754|EG023|Reported Event|MK-4166 3.3 mg + Pembro|Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191624|NCT02132754|EG024|Reported Event|MK-4166 10 mg + Pembro|Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191625|NCT02132754|EG025|Reported Event|MK-4166 30 mg + Pembro|Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191626|NCT02132754|EG026|Reported Event|MK-4166 42 mg + Pembro|Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191627|NCT02132754|EG027|Reported Event|MK-4166 59 mg + Pembro|Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191628|NCT02132754|EG028|Reported Event|MK-4166 82 mg + Pembro|Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191629|NCT02132754|EG029|Reported Event|MK-4166 120 mg + Pembro|Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191630|NCT02132754|EG030|Reported Event|MK-4166 170 mg + Pembro|Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191631|NCT02132754|EG031|Reported Event|MK-4166 240 mg + Pembro|Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191632|NCT02132754|EG032|Reported Event|MK-4166 340 mg + Pembro|Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11235897|NCT02446483|FG000|Participant Flow|Treatment A-rabeprazole 20mg,Then Treatment B-rabeprazole 20mg|Participants received one tablet of treatment A (rabeprazole 20 milligram [mg] enteric coated tablet) given with 240 milliliter (mL) water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. After a washout period of 7 days, participants then received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) given with 240 mL water. Participants were admitted the night before study drug administration, supervised for at least 10 hours (h) of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 ante meridiem (am) and 10:51 am on Day 1 of each study period.
11235898|NCT02446483|FG001|Participant Flow|Treatment B-rabeprazole 20mg,Then Treatment A-rabeprazole 20mg|Participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) given with 240 mL water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. After a washout period of 7 days, participants then received one tablet of treatment A (rabeprazole 20 mg enteric coated tablet) given with 240 mL water. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period.
11235899|NCT02446483|OG000|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
11235900|NCT02446483|OG001|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
11235901|NCT02446483|EG000|Reported Event|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
11235902|NCT02446483|EG001|Reported Event|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
11235903|NCT02446496|BG000|Baseline|Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram [gm] film coated [F.C.] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
11235904|NCT02446496|FG000|Participant Flow|Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram [gm] film coated [F.C.] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
11235905|NCT02446496|OG000|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
11235906|NCT02446496|OG001|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
11235907|NCT02446496|EG000|Reported Event|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
11235908|NCT02446496|EG001|Reported Event|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
11191633|NCT02132754|EG033|Reported Event|MK-4166 480 mg + Pembro|Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191634|NCT02132754|EG034|Reported Event|MK-4166 670 mg + Pembro|Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191635|NCT02132754|EG035|Reported Event|MK-4166 900 mg + Pembro|Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
11191636|NCT02132767|BG000|Baseline|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
11191637|NCT02132767|BG001|Baseline|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
11191638|NCT02132767|BG002|Baseline|Total|Total of all reporting groups
11191639|NCT02132767|FG000|Participant Flow|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
11191640|NCT02132767|FG001|Participant Flow|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
11191641|NCT02132767|OG000|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
11191642|NCT02132767|OG001|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
11184214|NCT02086162|FG001|Participant Flow|National Cancer Institute (NCI) Computerized Education|The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition [162] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
11184215|NCT02086162|OG000|Outcome|Let's Talk About Smoking|These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior [98], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) [140, 141]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment [142-144], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.
11184216|NCT02086162|OG001|Outcome|National Cancer Institute (NCI) Computerized Education|The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition [162] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
11184217|NCT02086162|OG000|Outcome|Let's Talk About Smoking|These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior, the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment). It also provides facts with simple text and pictures about risks and benefits for each cessation treatment, encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.
11184218|NCT02086162|OG001|Outcome|National Cancer Institute (NCI) Computerized Education|The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit), using large font text, limited content per screen, and audio, for the usual care control condition. This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
11184219|NCT02086162|OG000|Outcome|Behavioral Intervention|Web-based motivational decision support system
11184220|NCT02086162|OG001|Outcome|Educational Intervention|"Computerized version of the National Cancer Institute (NCI) Educational Pamphlet~NCI Education"
11184221|NCT02086162|EG000|Reported Event|Behavioral Intervention|These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior [98], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) [140, 141]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment [142-144], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.
11184222|NCT02086162|EG001|Reported Event|Educational Intervention|The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition [162] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
11184223|NCT02086331|BG000|Baseline|Healthy Subjects|
11184224|NCT02086331|FG000|Participant Flow|Healthy|Healthy participants
11184225|NCT02086331|OG000|Outcome|Subject 1|
11184226|NCT02086331|OG001|Outcome|Subject 2|
11184227|NCT02086331|OG002|Outcome|Subject 3|
11184228|NCT02086331|OG003|Outcome|Subject 4|
11184229|NCT02086331|OG000|Outcome|Day 1|
11184230|NCT02086331|OG001|Outcome|Day 2|
11184231|NCT02086331|EG000|Reported Event|Subject 1|
11184232|NCT02086331|EG001|Reported Event|Subject 2|
11184233|NCT02086331|EG002|Reported Event|Subject 3|
11184234|NCT02086331|EG003|Reported Event|Subject 4|
11184235|NCT02086331|EG004|Reported Event|Subject 5|
11184236|NCT02086500|BG000|Baseline|Prehospital Tranexamic Acid|"1 gram of Tranexamic Acid will be given during emergency medical transport~Tranexamic Acid: 1 gram of prehospital Tranexamic Acid"
11184237|NCT02086500|BG001|Baseline|Control|"Identical volume of saline during emergency medical transport~Saline control: Saline Control"
11184238|NCT02086500|BG002|Baseline|Total|Total of all reporting groups
11184239|NCT02086500|FG000|Participant Flow|Prehospital Tranexamic Acid|"1 gram of Tranexamic Acid will be given during emergency medical transport~Tranexamic Acid: 1 gram of prehospital Tranexamic Acid"
11184240|NCT02086500|FG001|Participant Flow|Control|"Identical volume of saline during emergency medical transport~Saline control: Saline Control"
11184241|NCT02086500|OG000|Outcome|Prehospital Tranexamic Acid|"1 gram of Tranexamic Acid will be given during emergency medical transport~Tranexamic Acid: 1 gram of prehospital Tranexamic Acid"
11184242|NCT02086500|OG001|Outcome|Control|"Identical volume of saline during emergency medical transport~Saline control: Saline Control"
11184243|NCT02086500|EG000|Reported Event|Prehospital Tranexamic Acid|"1 gram of Tranexamic Acid will be given during emergency medical transport~Tranexamic Acid: 1 gram of prehospital Tranexamic Acid"
11184244|NCT02086500|EG001|Reported Event|Control|"Identical volume of saline during emergency medical transport~Saline control: Saline Control"
11191643|NCT02132767|EG000|Reported Event|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
11191644|NCT02132767|EG001|Reported Event|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
11191645|NCT02132832|BG000|Baseline|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
11191646|NCT02132832|BG001|Baseline|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
11191647|NCT02132832|BG002|Baseline|Total|Total of all reporting groups
11191648|NCT02132832|FG000|Participant Flow|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
11191649|NCT02132832|FG001|Participant Flow|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
11191650|NCT02132832|OG000|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
11191651|NCT02132832|OG001|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
11191652|NCT02132832|EG000|Reported Event|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
11191653|NCT02132832|EG001|Reported Event|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
11191654|NCT02132910|BG000|Baseline|RESTORE Intervention|"First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use.~For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor.~For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor.~At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.~At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.~RESTORE Intervention"
11191655|NCT02132910|BG001|Baseline|Control Group 2|"First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use.~You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level.~At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.~At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health."
11191656|NCT02132910|BG002|Baseline|Total|Total of all reporting groups
11191657|NCT02132910|FG000|Participant Flow|RESTORE Intervention|"First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use.~For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor.~For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor.~At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.~At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.~RESTORE Intervention"
11184245|NCT02086565|BG000|Baseline|Portal Training and Home Visits|"Portal training and home visits from a community health worker to promote care coordination and use of the patient portal~Portal training and home visits: patient portal training and home visits by CHW to coordinate care"
11184246|NCT02086565|BG001|Baseline|Portal Training|"Participants are assured internet access and taught to use the patient portal~Portal training: training in use of patient portal"
11184247|NCT02086565|BG002|Baseline|Total|Total of all reporting groups
11184248|NCT02086565|FG000|Participant Flow|Portal Training and Home Visits|"Portal training and home visits from a community health worker to promote care coordination and use of the patient portal~Portal training and home visits: patient portal training and home visits by CHW to coordinate care"
11184249|NCT02086565|FG001|Participant Flow|Portal Training|"Participants are assured internet access and taught to use the patient portal~Portal training: training in use of patient portal"
11184250|NCT02086565|OG000|Outcome|Portal Training and Home Visits|"Portal training and home visits from a community health worker to promote care coordination and use of the patient portal~Portal training and home visits: patient portal training and home visits by CHW to coordinate care"
11184251|NCT02086565|OG001|Outcome|Portal Training|"Participants are assured internet access and taught to use the patient portal~Portal training: training in use of patient portal"
11184252|NCT02086565|EG000|Reported Event|Portal Training and Home Visits|"Portal training and home visits from a community health worker to promote care coordination and use of the patient portal~Portal training and home visits: patient portal training and home visits by CHW to coordinate care"
11184253|NCT02086565|EG001|Reported Event|Portal Training|"Participants are assured internet access and taught to use the patient portal~Portal training: training in use of patient portal"
11184254|NCT02086591|BG000|Baseline|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
11184255|NCT02086591|FG000|Participant Flow|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
11184256|NCT02086591|OG000|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
11184257|NCT02086591|EG000|Reported Event|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
11184258|NCT02086682|BG000|Baseline|General Care Cohort|The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.
11184259|NCT02086682|BG001|Baseline|Critical Care Cohort|The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
11184260|NCT02086682|BG002|Baseline|Total|Total of all reporting groups
11184261|NCT02086682|FG000|Participant Flow|General Care Cohort|The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.
11184262|NCT02086682|FG001|Participant Flow|Critical Care Cohort|The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
11184263|NCT02086682|OG000|Outcome|General Care Cohort|The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.
11184264|NCT02086682|OG001|Outcome|Critical Care Cohort|The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
11184265|NCT02086682|EG000|Reported Event|General Care Cohort|The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.
11184266|NCT02086682|EG001|Reported Event|Critical Care Cohort|The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
11184267|NCT02086708|BG000|Baseline|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.~Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
11184268|NCT02086708|FG000|Participant Flow|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.~Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
11184269|NCT02086708|OG000|Outcome|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
11184270|NCT02086708|OG001|Outcome|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
11184271|NCT02086708|OG002|Outcome|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
11184272|NCT02086708|OG003|Outcome|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
11184273|NCT02086708|OG004|Outcome|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
11184274|NCT02086708|EG000|Reported Event|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
11184275|NCT02086708|EG001|Reported Event|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
11184276|NCT02086708|EG002|Reported Event|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
11184277|NCT02086708|EG003|Reported Event|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
11184278|NCT02086708|EG004|Reported Event|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
11184279|NCT02086786|BG000|Baseline|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
11184280|NCT02086786|BG001|Baseline|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
11184281|NCT02086786|BG002|Baseline|Total|Total of all reporting groups
11184282|NCT02086786|FG000|Participant Flow|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
11184283|NCT02086786|FG001|Participant Flow|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
11184284|NCT02086786|OG000|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.~Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals."
11184285|NCT02086786|OG001|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.~Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals."
11184286|NCT02086786|OG000|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
11184287|NCT02086786|OG001|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
11184288|NCT02086786|EG000|Reported Event|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
11184289|NCT02086786|EG001|Reported Event|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
11184290|NCT02086968|BG000|Baseline|Injectafer|"2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg~Injectafer: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg"
11184291|NCT02086968|BG001|Baseline|Ferrous Sulfate Tablets|"Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days~Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days"
11184292|NCT02086968|BG002|Baseline|Total|Total of all reporting groups
11184293|NCT02086968|FG000|Participant Flow|Injectafer|2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg
11184294|NCT02086968|FG001|Participant Flow|Ferrous Sulfate Tablets|Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
11184295|NCT02086968|OG000|Outcome|Injectafer|"2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg~Injectafer: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg"
11184296|NCT02086968|OG001|Outcome|Ferrous Sulfate Tablets|"Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days~Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days"
11184297|NCT02086968|EG000|Reported Event|Injectafer|"2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg~Injectafer: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg"
11184298|NCT02086968|EG001|Reported Event|Ferrous Sulfate Tablets|"Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days~Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days"
11184299|NCT02087046|BG000|Baseline|Stimulation|ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
11184300|NCT02087046|FG000|Participant Flow|Stimulation|ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
11184301|NCT02087046|OG000|Outcome|Stimulation|ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
11184302|NCT02087046|OG000|Outcome|Stimulation|ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in theVIM nucleus of the thalamus
11184303|NCT02087046|EG000|Reported Event|Stimulation|ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
11184304|NCT02087059|BG000|Baseline|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
11184305|NCT02087059|FG000|Participant Flow|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
11184306|NCT02087059|OG000|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
11184307|NCT02087059|EG000|Reported Event|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
11184308|NCT02087085|BG000|Baseline|400 µg Brimonidine Implant|400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
11184309|NCT02087085|BG001|Baseline|Sham|Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
11184310|NCT02087085|BG002|Baseline|Total|Total of all reporting groups
11184311|NCT02087085|FG000|Participant Flow|400 µg Brimonidine Implant|400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
11184312|NCT02087085|FG001|Participant Flow|Sham|Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless drug delivery system (DDS) applicator every 3 months from Baseline (Day 1) through Month 21.
11184313|NCT02087085|OG000|Outcome|400 µg Brimonidine Implant|400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
11184314|NCT02087085|OG001|Outcome|Sham|Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
11184315|NCT02087085|EG000|Reported Event|400 µg Brimonidine Implant|400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
11184316|NCT02087085|EG001|Reported Event|Sham|Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
11184317|NCT02087150|BG000|Baseline|Lead-In|Subjects enrolled in Lead-In Group
11184318|NCT02087150|BG001|Baseline|Randomized ETBC|Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
11184319|NCT02087150|BG002|Baseline|Randomized MM|Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
11184320|NCT02087150|BG003|Baseline|Total|Total of all reporting groups
11184321|NCT02087150|FG000|Participant Flow|Lead-In|Subjects enrolled in Lead-In Group
11184322|NCT02087150|FG001|Participant Flow|Randomized ETBC|Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
11184323|NCT02087150|FG002|Participant Flow|Randomized MM|Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
11184324|NCT02087150|OG000|Outcome|Randomized ETBC|Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
11184325|NCT02087150|OG001|Outcome|Randomized MM|Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
11184326|NCT02087150|EG000|Reported Event|Lead-In|Subjects enrolled in the Lead-in group and treated with the ETBC
11184327|NCT02087150|EG001|Reported Event|Randomized ETBC|Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
11184328|NCT02087150|EG002|Reported Event|Crossover MM|Subjects enrolled and randomized to treatment with Medical Management (MM) only who crossed over to have treatment with the ETBC after the 6-week follow-up visit
11184329|NCT02087150|EG003|Reported Event|ALL ETBC|All subjects in the lead-in phase, subjects randomized to the investigational arm who received treatment with the ETBC, and subjects in the control arm who crossed over to have treatment with the ETBC
11184330|NCT02087150|EG004|Reported Event|Randomized MM|Subjects enrolled and randomized to treatment with Medical Management (MM) only
11184331|NCT02087163|BG000|Baseline|Movement Enhancement Technique|"Movement Enhancement Technique Clear Aligner~Movement Enhancement Technique: Conventional Orthodontic treatment~Clear Aligner: Orthodontic treatment with Clear Aligner"
11184332|NCT02087163|FG000|Participant Flow|Movement Enhancement Technique|"Movement Enhancement Technique Clear Aligner~Movement Enhancement Technique: Conventional Orthodontic treatment~Clear Aligner: Orthodontic treatment with Clear Aligner"
11184333|NCT02087163|OG000|Outcome|Movement Enhancement Technique|"Movement Enhancement Technique Clear Aligner~Movement Enhancement Technique: Conventional Orthodontic treatment~Clear Aligner: Orthodontic treatment with Clear Aligner"
11184334|NCT02087163|EG000|Reported Event|Movement Enhancement Technique|"Movement Enhancement Technique Clear Aligner~Movement Enhancement Technique: Conventional Orthodontic treatment~Clear Aligner: Orthodontic treatment with Clear Aligner"
11184335|NCT02087176|BG000|Baseline|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
11184336|NCT02087176|FG000|Participant Flow|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
11184337|NCT02087176|OG000|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
11184338|NCT02087176|EG000|Reported Event|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
11184339|NCT02087241|BG000|Baseline|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184340|NCT02087241|BG001|Baseline|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
11184341|NCT02087241|BG002|Baseline|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184342|NCT02087241|BG003|Baseline|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
11184343|NCT02087241|BG004|Baseline|Total|Total of all reporting groups
11184344|NCT02087241|FG000|Participant Flow|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184345|NCT02087241|FG001|Participant Flow|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
11184346|NCT02087241|FG002|Participant Flow|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184347|NCT02087241|FG003|Participant Flow|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
11184348|NCT02087241|OG000|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
11184349|NCT02087241|OG001|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
11184350|NCT02087241|OG002|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184351|NCT02087241|OG003|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
11184352|NCT02087241|OG001|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184353|NCT02087241|OG000|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184354|NCT02087241|OG003|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
11184355|NCT02087241|OG003|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
11184356|NCT02087241|EG000|Reported Event|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184357|NCT02087241|EG001|Reported Event|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
11184358|NCT02087241|EG002|Reported Event|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
11184359|NCT02087241|EG003|Reported Event|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
11184360|NCT02087306|BG000|Baseline|Cohort A|"Allogeneic hematopoietic cell transplant recipients at risk of progression to disseminated adenovirus (AdV) disease (i.e., subjects with either asymptomatic AdV infection or localized adenovirus disease) and who weighed ≤120 kg.~Subjects who weighed <50 kg received 2 mg/kg (not-to-exceed 100 mg) brincidofovir (BCV) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received BCV 100 mg twice weekly, administered orally as one 100-mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184361|NCT02087306|BG001|Baseline|Cohort B|"Allogeneic hematopoietic cell transplant recipients with disseminated adenovirus disease who weigh ≤120 kg.~Subjects who weighed <50 kg received 2 mg/kg brincidofovir (BCV; not to exceed 100 mg) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received 100 mg BCV twice weekly, administered orally as one 100 mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184362|NCT02087306|BG002|Baseline|Cohort C|"Allogeneic hematopoietic cell transplant recipients who weighed >120 kg and all other immunocompromised subjects with disseminated adenovirus (AdV) disease or subjects who were at risk of progression to disseminated AdV disease, as well as non-immunocompromised subjects with disseminated AdV disease.~Subjects who weighed <50 kg received 2 mg/kg (not to exceed 100 mg) brincidofovir (BCV) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received 100 mg BCV twice weekly, administered orally as one 100-mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184363|NCT02087306|BG003|Baseline|Total|Total of all reporting groups
11184364|NCT02087306|FG000|Participant Flow|Cohort A|"Allogeneic hematopoietic cell transplant recipients at risk of progression to disseminated adenovirus (AdV) disease (i.e., subjects with either asymptomatic AdV infection or localized adenovirus disease) and who weighed ≤120 kg.~Subjects who weighed <50 kg received 2 mg/kg (not-to-exceed 100 mg) brincidofovir (BCV) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received BCV 100 mg twice weekly, administered orally as one 100-mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184365|NCT02087306|FG001|Participant Flow|Cohort B|"Allogeneic hematopoietic cell transplant recipients with disseminated adenovirus disease who weigh ≤120 kg.~Subjects who weighed <50 kg received 2 mg/kg brincidofovir (BCV; not to exceed 100 mg) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received 100 mg BCV twice weekly, administered orally as one 100 mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184366|NCT02087306|FG002|Participant Flow|Cohort C|"Allogeneic hematopoietic cell transplant recipients who weighed >120 kg and all other immunocompromised subjects with disseminated adenovirus (AdV) disease or subjects who were at risk of progression to disseminated AdV disease, as well as non-immunocompromised subjects with disseminated AdV disease.~Subjects who weighed <50 kg received 2 mg/kg (not to exceed 100 mg) brincidofovir (BCV) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received 100 mg BCV twice weekly, administered orally as one 100-mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184367|NCT02087306|OG000|Outcome|Cohort A|"Allogeneic hematopoietic cell transplant recipients at risk of progression to disseminated adenovirus (AdV) disease (i.e., subjects with either asymptomatic AdV infection or localized adenovirus disease) and who weighed ≤120 kg.~Subjects who weighed <50 kg received 2 mg/kg (not-to-exceed 100 mg) brincidofovir (BCV) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received BCV 100 mg twice weekly, administered orally as one 100-mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184368|NCT02087306|OG001|Outcome|Cohort B|"Allogeneic hematopoietic cell transplant recipients with disseminated adenovirus disease who weigh ≤120 kg.~Subjects who weighed <50 kg received 2 mg/kg brincidofovir (BCV; not to exceed 100 mg) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received 100 mg BCV twice weekly, administered orally as one 100 mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184369|NCT02087306|OG002|Outcome|Cohort C|"Allogeneic hematopoietic cell transplant recipients who weighed >120 kg and all other immunocompromised subjects with disseminated adenovirus (AdV) disease or subjects who were at risk of progression to disseminated AdV disease, as well as non-immunocompromised subjects with disseminated AdV disease.~Subjects who weighed <50 kg received 2 mg/kg (not to exceed 100 mg) brincidofovir (BCV) twice weekly, administered orally as the appropriate volume of 10-mg/mL liquid suspension.~Subjects who weighed ≥50 kg received 100 mg BCV twice weekly, administered orally as one 100-mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine)."
11184370|NCT02087306|EG000|Reported Event|Pediatric|Subjects aged 2 months to <18 years.
11184371|NCT02087306|EG001|Reported Event|Adult|Subjects aged ≥18 years
11184372|NCT02087514|BG000|Baseline|Transfusion of PRBC Stored for 1 Week|"Subjects will receive blood transfusion with packed red blood cells stored for 1 week.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184373|NCT02087514|BG001|Baseline|Transfusion of PRBC Stored for 2 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184374|NCT02087514|BG002|Baseline|Transfusion of PRBC Stored for 3 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184375|NCT02087514|BG003|Baseline|Transfusion of PRBC Stored for 4 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184376|NCT02087514|BG004|Baseline|Transfusion of PRBC Stored for 5 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184377|NCT02087514|BG005|Baseline|Transfusion of PRBC Stored for 6 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184378|NCT02087514|BG006|Baseline|Total|Total of all reporting groups
11184379|NCT02087514|FG000|Participant Flow|Transfusion of PRBC Stored for 1 Week|"Subjects will receive blood transfusion with packed red blood cells stored for 1 week.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184380|NCT02087514|FG001|Participant Flow|Transfusion of PRBC Stored for 2 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184381|NCT02087514|FG002|Participant Flow|Transfusion of PRBC Stored for 3 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11341440|NCT03682120|OG003|Outcome|7.5 mcg A/H7N9|15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11184382|NCT02087514|FG003|Participant Flow|Transfusion of PRBC Stored for 4 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184383|NCT02087514|FG004|Participant Flow|Transfusion of PRBC Stored for 5 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184384|NCT02087514|FG005|Participant Flow|Transfusion of PRBC Stored for 6 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184385|NCT02087514|OG000|Outcome|Transfusion of PRBC Stored for 1 Week|"Subjects will receive blood transfusion with packed red blood cells stored for 1 week.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184386|NCT02087514|OG001|Outcome|Transfusion of PRBC Stored for 2 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184387|NCT02087514|OG002|Outcome|Transfusion of PRBC Stored for 3 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184388|NCT02087514|OG003|Outcome|Transfusion of PRBC Stored for 4 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184389|NCT02087514|OG004|Outcome|Transfusion of PRBC Stored for 5 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184390|NCT02087514|OG005|Outcome|Transfusion of PRBC Stored for 6 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184391|NCT02087514|EG000|Reported Event|Transfusion of PRBC Stored for 1 Week|"Subjects will receive blood transfusion with packed red blood cells stored for 1 week.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11235909|NCT02446613|BG000|Baseline|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
11235910|NCT02446613|BG001|Baseline|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
11235911|NCT02446613|BG002|Baseline|Total|Total of all reporting groups
11235912|NCT02446613|FG000|Participant Flow|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to nasal allergen challenge (NAC) at Visit 2 to investigate the long term effect of matching placebo, intranasal (i.n.), administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 hours (h) post NAC.
11235913|NCT02446613|FG001|Participant Flow|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 nanograms (ng), i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post NAC.
11235914|NCT02446613|OG000|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
11235915|NCT02446613|OG001|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
11235916|NCT02446613|OG001|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
11235917|NCT02446613|OG001|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
11235918|NCT02446613|OG000|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
11235919|NCT02446613|OG001|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym were recorded up to 6 h post-NAC.
11235920|NCT02446613|EG000|Reported Event|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
11235921|NCT02446613|EG001|Reported Event|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
11235922|NCT02446691|BG000|Baseline|MenACWY Group|Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
11235923|NCT02446691|FG000|Participant Flow|MenACWY Group|Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
11235924|NCT02446691|OG000|Outcome|MenACWY Group|Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
11235925|NCT02446691|EG000|Reported Event|MenACWY Group|Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
11235926|NCT02446717|BG000|Baseline|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235927|NCT02446717|BG001|Baseline|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235928|NCT02446717|BG002|Baseline|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235929|NCT02446717|BG003|Baseline|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
11235930|NCT02446717|BG004|Baseline|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
11235931|NCT02446717|BG005|Baseline|Total|Total of all reporting groups
11235932|NCT02446717|FG000|Participant Flow|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235933|NCT02446717|FG001|Participant Flow|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235934|NCT02446717|FG002|Participant Flow|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235935|NCT02446717|FG003|Participant Flow|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
11235936|NCT02446717|FG004|Participant Flow|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
11235937|NCT02446717|OG000|Outcome|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235938|NCT02446717|OG001|Outcome|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235939|NCT02446717|OG002|Outcome|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235940|NCT02446717|OG003|Outcome|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
11235941|NCT02446717|OG004|Outcome|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
11235942|NCT02446717|EG000|Reported Event|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235943|NCT02446717|EG001|Reported Event|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235944|NCT02446717|EG002|Reported Event|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
11235945|NCT02446717|EG003|Reported Event|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
11235946|NCT02446717|EG004|Reported Event|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
11235947|NCT02446743|BG000|Baseline|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
11235948|NCT02446743|BG001|Baseline|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
11235949|NCT02446743|BG002|Baseline|Total|Total of all reporting groups
11235950|NCT02446743|FG000|Participant Flow|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
11235951|NCT02446743|FG001|Participant Flow|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
11235952|NCT02446743|OG000|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
11235953|NCT02446743|OG001|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
11235954|NCT02446743|OG002|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
11235955|NCT02446743|OG003|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
11235956|NCT02446743|OG004|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
11235957|NCT02446743|OG005|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
11235958|NCT02446743|OG000|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
11235959|NCT02446743|OG001|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
11235960|NCT02446743|OG000|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
11235961|NCT02446743|OG001|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
11235962|NCT02446743|OG002|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
11235963|NCT02446743|EG000|Reported Event|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 month schedule in studies V72_41 or V72P10, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
11235964|NCT02446743|EG001|Reported Event|Group B_0_1|Naive subjects from V72_41 or V72P10 studies, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
11235965|NCT02446769|BG000|Baseline|All Participants|All participants that were consented.
11235966|NCT02446769|FG000|Participant Flow|Screening Period|All participants that signed the consent.
11235967|NCT02446769|FG001|Participant Flow|Standard of Care|Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
11235968|NCT02446769|FG002|Participant Flow|Experimental: AVAPS-AE Non-invasive Ventilation Therapy|Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable Inspiratory Positive Airway Pressure (IPAP) setting to maintain target ventilation with a settable rate of change), Auto Expiratory Positive Airway Pressure (EPAP) and Auto Back up Rate.
11235969|NCT02446769|OG000|Outcome|AVAPS-AE Non-invasive Ventilation Therapy|"Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.~AVAPS-AE Non-invasive ventilation therapy: Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge."
11235970|NCT02446769|OG001|Outcome|Standard of Care Group|Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
11235971|NCT02446769|EG000|Reported Event|Screening Period|All participants that signed the consent.
11235972|NCT02446769|EG001|Reported Event|Standard of Care|Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
11235973|NCT02446769|EG002|Reported Event|Experimental: AVAPS-AE Non-invasive Ventilation Therapy|Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.
11235974|NCT02446847|BG000|Baseline|Group A: 3BNC117 IV + ART Interruption|"Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.~3BNC117: 3BNC117 infusions~ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12."
11235975|NCT02446847|BG001|Baseline|Group B: 3BNC117 IV + ART Interruption|"Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.~3BNC117: 3BNC117 infusions~ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12."
11235976|NCT02446847|BG002|Baseline|Total|Total of all reporting groups
11235977|NCT02446847|FG000|Participant Flow|Group A: 3BNC117 IV + ART Interruption|"Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.~3BNC117: 3BNC117 infusions~ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12."
11235978|NCT02446847|FG001|Participant Flow|Group B: 3BNC117 IV + ART Interruption|"Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.~3BNC117: 3BNC117 infusions~ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12."
11235979|NCT02446847|OG000|Outcome|Group A: 3BNC117 IV + ART Interruption|"Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.~3BNC117: 3BNC117 infusions~ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12."
11235980|NCT02446847|OG001|Outcome|Group B: 3BNC117 IV + ART Interruption|"Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.~3BNC117: 3BNC117 infusions~ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12."
11235981|NCT02446847|EG000|Reported Event|Group A: 3BNC117 IV + ART Interruption|"Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.~3BNC117: 3BNC117 infusions~ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12."
11235982|NCT02446847|EG001|Reported Event|Group B: 3BNC117 IV + ART Interruption|"Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.~3BNC117: 3BNC117 infusions~ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12."
11341441|NCT03682120|OG000|Outcome|3.75 mcg A/H7N9+MF596|3.75 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11184392|NCT02087514|EG001|Reported Event|Transfusion of PRBC Stored for 2 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184393|NCT02087514|EG002|Reported Event|Transfusion of PRBC Stored for 3 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184394|NCT02087514|EG003|Reported Event|Transfusion of PRBC Stored for 4 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184395|NCT02087514|EG004|Reported Event|Transfusion of PRBC Stored for 5 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184396|NCT02087514|EG005|Reported Event|Transfusion of PRBC Stored for 6 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
11184397|NCT02087670|BG000|Baseline|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
11184398|NCT02087670|BG001|Baseline|Community Based Exercise|educational program and not supervises exercise program
11184399|NCT02087670|BG002|Baseline|Total|Total of all reporting groups
11184400|NCT02087670|FG000|Participant Flow|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
11184401|NCT02087670|FG001|Participant Flow|Community Based Exercise|educational program and not supervises exercise program
11184402|NCT02087670|OG000|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
11184403|NCT02087670|OG001|Outcome|Community Based Exercise|educational program and not supervises exercise program
11184404|NCT02087670|EG000|Reported Event|Controlled, Supervised Exercise Protocol|controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program
11184405|NCT02087670|EG001|Reported Event|Community Based Exercise|educational program and not supervises exercise program
11184406|NCT02087748|BG000|Baseline|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
11184407|NCT02087748|FG000|Participant Flow|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
11184408|NCT02087748|OG000|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours~1% diclofenac sodium gel"
11184409|NCT02087748|OG001|Outcome|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours~Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
11184410|NCT02087748|OG000|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours~1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
11184411|NCT02087748|OG001|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours~Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
11184412|NCT02087748|EG000|Reported Event|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours~1% diclofenac sodium gel"
11184413|NCT02087748|EG001|Reported Event|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours~Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
11184414|NCT02087774|BG000|Baseline|Control School|Control School received no intervention.
11184415|NCT02087774|BG001|Baseline|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
11184416|NCT02087774|BG002|Baseline|Total|Total of all reporting groups
11184417|NCT02087774|FG000|Participant Flow|Control School|Control School received no intervention.
11341442|NCT03682120|EG000|Reported Event|3.75 mcg A/H7N9+MF59|3.75 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11235983|NCT02446886|BG000|Baseline|One Time Treatment|"MS patients enrolled in this study will be randomized into:~Intervention for Group A: 80 units/day ACTH (H.P. Acthar®)for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.)~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin receptors."
11235984|NCT02446886|BG001|Baseline|Monthly Treatments|"Intervention for Group B: 80 units/day ACTH (H.P. Acthar®) for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.), followed by monthly 80 units/day ACTH for 3 days for 12 months of treatment.~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin receptors."
11235985|NCT02446886|BG002|Baseline|Total|Total of all reporting groups
11235986|NCT02446886|FG000|Participant Flow|One Time Treatment|"MS patients enrolled in this study will be randomized into:~Intervention for Group A: 80 units/day ACTH (H.P. Acthar®)for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.)~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin receptors."
11235987|NCT02446886|FG001|Participant Flow|Monthly Treatments|"Intervention for Group B: 80 units/day ACTH (H.P. Acthar®) for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.), followed by monthly 80 units/day ACTH for 3 days for 12 months of treatment.~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin recep"
11235988|NCT02446886|OG000|Outcome|One Time Treatment|"MS patients enrolled in this study will be randomized into:~Intervention for Group A: 80 units/day ACTH (H.P. Acthar®)for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.)~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin receptors."
11235989|NCT02446886|OG001|Outcome|Monthly Treatments|"Intervention for Group B: 80 units/day ACTH (H.P. Acthar®) for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.), followed by monthly 80 units/day ACTH for 3 days for 12 months of treatment.~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin recep"
11341443|NCT03682120|EG001|Reported Event|7.5 mcg A/H7N9+MF59|7.5 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11341444|NCT03682120|EG002|Reported Event|15 mcg A/H7N9+MF59|15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11184418|NCT02087774|FG001|Participant Flow|Intervention Group|"Two schools participated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~One intervention school implemented the program with responsibility given to the principal (school-wide group) and the other school asked the individual teachers to implement the program daily (classroom based group).~Physical Activity and Incentives"
11184419|NCT02087774|OG000|Outcome|Control School|Control School received no intervention.
11184420|NCT02087774|OG001|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
11184421|NCT02087774|EG000|Reported Event|Control School|Control School received no intervention.
11184422|NCT02087774|EG001|Reported Event|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
11184423|NCT02087904|BG000|Baseline|Placebo|Matching placebo SC E2W
11184424|NCT02087904|BG001|Baseline|ABT-981 25 mg|25 mg ABT-981 SC E2W
11184425|NCT02087904|BG002|Baseline|ABT-981 100 mg|100 mg ABT-981 SC E2W
11184426|NCT02087904|BG003|Baseline|ABT-981 200 mg|200 mg ABT-981 SC E2W
11184427|NCT02087904|BG004|Baseline|Total|Total of all reporting groups
11184428|NCT02087904|FG000|Participant Flow|Placebo|Matching placebo SC E2W
11184429|NCT02087904|FG001|Participant Flow|ABT-981 25 mg|25 mg ABT-981 SC E2W
11184430|NCT02087904|FG002|Participant Flow|ABT-981 100 mg|100 mg ABT-981 SC E2W
11184431|NCT02087904|FG003|Participant Flow|ABT-981 200 mg|200 mg ABT-981 SC E2W
11184432|NCT02087904|OG000|Outcome|Placebo|Matching placebo SC E2W
11184433|NCT02087904|OG001|Outcome|ABT-981 25 mg|25 mg ABT-981 SC E2W
11184434|NCT02087904|OG002|Outcome|ABT-981 100 mg|100 mg ABT-981 SC E2W
11184435|NCT02087904|OG003|Outcome|ABT-981 200 mg|200 mg ABT-981 SC E2W
11184436|NCT02087904|EG000|Reported Event|Placebo|Matching placebo SC E2W
11184437|NCT02087904|EG001|Reported Event|ABT-981 25 mg|25 mg ABT-981 SC E2W
11184438|NCT02087904|EG002|Reported Event|ABT-981 100 mg|100 mg ABT-981 SC E2W
11184439|NCT02087904|EG003|Reported Event|ABT-981 200 mg|200 mg ABT-981 SC E2W
11184440|NCT02087943|BG000|Baseline|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
11184441|NCT02087943|BG001|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
11184442|NCT02087943|BG002|Baseline|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
11184443|NCT02087943|BG003|Baseline|Total|Total of all reporting groups
11184444|NCT02087943|FG000|Participant Flow|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
11184445|NCT02087943|FG001|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase
11184446|NCT02087943|FG002|Participant Flow|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase.
11184447|NCT02087943|FG003|Participant Flow|Placebo/Apremilast 30 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24.
11184448|NCT02087943|FG004|Participant Flow|Placebo/Apremilast 40 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24.
11184449|NCT02087943|OG000|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
11184450|NCT02087943|OG001|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
11184451|NCT02087943|OG002|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
11184452|NCT02087943|OG000|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 30 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 30 mg apremilast tablets twice daily in the active treatment phase.
11184453|NCT02087943|OG001|Outcome|Apremilast 40 mg|Participants initially randomized to 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 40 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment phase, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 40 mg apremilast tablets twice daily in the active treatment phase.
11184454|NCT02087943|EG000|Reported Event|Placebo (Weeks 0-12)|Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
11184455|NCT02087943|EG001|Reported Event|Apremilast 30 mg (Weeks 0-12)|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
11184456|NCT02087943|EG002|Reported Event|Apremilast 40 mg (Weeks 0-12)|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
11184457|NCT02087943|EG003|Reported Event|Apremilast 30 mg (Apremilast Exposure Period) 0-24|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
11341445|NCT03682120|EG003|Reported Event|15 mcg A/H7N9|15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11184458|NCT02087943|EG004|Reported Event|Apremilast 40 mg (Apremilast Exposure Period) 0-24|Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
11184459|NCT02087956|BG000|Baseline|Personalized Support for Progress (PSP)|"In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.~Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed."
11184460|NCT02087956|BG001|Baseline|Enhanced Screening and Referral (ESR)|"(ESR)- participant will receive personal report of their current needs and list of resources available in the community.~Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free."
11184461|NCT02087956|BG002|Baseline|Total|Total of all reporting groups
11184462|NCT02087956|FG000|Participant Flow|Personalized Support for Progress (PSP)|"In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.~Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed."
11184463|NCT02087956|FG001|Participant Flow|Enhanced Screening and Referral (ESR)|"(ESR)- participant will receive personal report of their current needs and list of resources available in the community.~Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free."
11184464|NCT02087956|OG000|Outcome|Personalized Support for Progress (PSP)|"In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.~Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed."
11184465|NCT02087956|OG001|Outcome|Enhanced Screening and Referral (ESR)|"(ESR)- participant will receive personal report of their current needs and list of resources available in the community.~Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free."
11184466|NCT02087956|OG000|Outcome|Enhanced Screening and Referral (ESR)|"(ESR)- participant will receive personal report of their current needs and list of resources available in the community.~Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free."
11184467|NCT02087956|OG001|Outcome|Personalized Support for Progress (PSP)|"In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.~Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed."
11184468|NCT02087956|EG000|Reported Event|Personalized Support for Progress (PSP)|"In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.~Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed."
11184469|NCT02087956|EG001|Reported Event|Enhanced Screening and Referral (ESR)|"Enhanced Screen and Referral (ESR)- participant will receive personal report of their current needs and list of resources available in the community.~Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free."
11184470|NCT02087995|BG000|Baseline|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
11184471|NCT02087995|FG000|Participant Flow|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
11184472|NCT02087995|OG000|Outcome|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
11184473|NCT02087995|EG000|Reported Event|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
11235990|NCT02446886|OG001|Outcome|Monthly Treatments|"Intervention for Group B: 80 units/day ACTH (H.P. Acthar®) for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.), followed by monthly 80 units/day ACTH for 3 days for 12 months of treatment.~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin receptors."
11235991|NCT02446886|EG000|Reported Event|One Time Treatment|"MS patients enrolled in this study will be randomized into:~Intervention for Group A: 80 units/day ACTH (H.P. Acthar®)for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.)~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin receptors."
11235992|NCT02446886|EG001|Reported Event|Monthly Treatments|"Intervention for Group B: 80 units/day ACTH (H.P. Acthar®) for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.), followed by monthly 80 units/day ACTH for 3 days for 12 months of treatment.~Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®): Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin recep"
11235993|NCT02446899|BG000|Baseline|Anifrolumab 300 mg|Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
11235994|NCT02446899|BG001|Baseline|Placebo|Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
11235995|NCT02446899|BG002|Baseline|Total|Total of all reporting groups
11235996|NCT02446899|FG000|Participant Flow|Anifrolumab 300 mg|Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
11235997|NCT02446899|FG001|Participant Flow|Placebo|Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
11235998|NCT02446899|OG000|Outcome|Anifrolumab 300 mg|Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
11235999|NCT02446899|OG001|Outcome|Placebo|Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
11236000|NCT02446899|EG000|Reported Event|Anifrolumab 300 mg|Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
11236001|NCT02446899|EG001|Reported Event|Placebo|Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
11236002|NCT02446912|BG000|Baseline|Anifrolumab 150 mg|Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236003|NCT02446912|BG001|Baseline|Anifrolumab 300 mg|Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236004|NCT02446912|BG002|Baseline|Placebo|Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236005|NCT02446912|BG003|Baseline|Total|Total of all reporting groups
11236006|NCT02446912|FG000|Participant Flow|Anifrolumab 150 mg|Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236007|NCT02446912|FG001|Participant Flow|Anifrolumab 300 mg|Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236008|NCT02446912|FG002|Participant Flow|Placebo|Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236009|NCT02446912|OG000|Outcome|Anifrolumab 150 mg|Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236010|NCT02446912|OG001|Outcome|Anifrolumab 300 mg|Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236011|NCT02446912|OG002|Outcome|Placebo|Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236012|NCT02446912|EG000|Reported Event|Anifrolumab 150 mg|Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236013|NCT02446912|EG001|Reported Event|Anifrolumab 300 mg|Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236014|NCT02446912|EG002|Reported Event|Placebo|Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
11236015|NCT02446990|BG000|Baseline|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
11236016|NCT02446990|BG001|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
11236017|NCT02446990|BG002|Baseline|Total|Total of all reporting groups
11184474|NCT02088034|BG000|Baseline|Promotora-led Intervention|"The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.~Prometra led intervention: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week."
11184475|NCT02088034|BG001|Baseline|Usual Care|"One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.~Usual Care: Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials."
11184476|NCT02088034|BG002|Baseline|Metformin Therapy|"Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.~Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year."
11184477|NCT02088034|BG003|Baseline|Total|Total of all reporting groups
11184478|NCT02088034|FG000|Participant Flow|Promotora-led Intervention|"The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.~Prometra led intervention: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week."
11184479|NCT02088034|FG001|Participant Flow|Usual Care|"One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.~Usual Care: Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials."
11184480|NCT02088034|FG002|Participant Flow|Metformin Therapy|"Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.~Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year."
11184481|NCT02088034|OG000|Outcome|Promotora-led Intervention|"The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.~Prometra led intervention: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week."
11184482|NCT02088034|OG001|Outcome|Usual Care|"One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.~Usual Care: Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials."
11184483|NCT02088034|OG002|Outcome|Metformin Therapy|"Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.~Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year."
11184484|NCT02088034|EG000|Reported Event|Promotora-led Intervention|"The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.~Prometra led intervention: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week."
11184485|NCT02088034|EG001|Reported Event|Usual Care|"One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.~Usual Care: Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials."
11184486|NCT02088034|EG002|Reported Event|Metformin Therapy|"Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.~Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year."
11184487|NCT02088047|BG000|Baseline|Profoveate|The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment.
11236018|NCT02446990|FG000|Participant Flow|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
11236019|NCT02446990|FG001|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
11236020|NCT02446990|OG000|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
11236021|NCT02446990|OG001|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
11236022|NCT02446990|EG000|Reported Event|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
11236023|NCT02446990|EG001|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
11236024|NCT02447003|BG000|Baseline|Cohort A: Pembrolizumab|Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years). Qualified participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
11236025|NCT02447003|BG001|Baseline|Cohort B: Pembrolizumab|Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years). Qualified participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
11236026|NCT02447003|BG002|Baseline|Total|Total of all reporting groups
11236027|NCT02447003|FG000|Participant Flow|Cohort A: Pembrolizumab|Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years). Qualified participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
11236028|NCT02447003|FG001|Participant Flow|Cohort B: Pembrolizumab|Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years). Qualified participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
11236029|NCT02447003|OG000|Outcome|Cohort A: Pembrolizumab|Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).
11236030|NCT02447003|OG001|Outcome|Cohort B: Pembrolizumab|Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).
11236031|NCT02447003|EG000|Reported Event|Cohort A: Pembrolizumab First Course|Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).
11236032|NCT02447003|EG001|Reported Event|Cohort A: Pembrolizumab Second Course|Qualified Cohort A participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W) for up to 17 cycles (up to ~1 year).
11236033|NCT02447003|EG002|Reported Event|Cohort B: Pembrolizumab First Course|Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years).
11236034|NCT02447003|EG003|Reported Event|Cohort B: Pembrolizumab Second Course|Qualified Cohort B participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 17 cycles (up to ~1 year).
11236035|NCT02447029|BG000|Baseline|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
11236036|NCT02447029|BG001|Baseline|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
11236037|NCT02447029|BG002|Baseline|Total|Total of all reporting groups
11236038|NCT02447029|FG000|Participant Flow|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
11236039|NCT02447029|FG001|Participant Flow|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
11184488|NCT02088047|BG001|Baseline|NonProFoveate|Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.
11184489|NCT02088047|BG002|Baseline|Total|Total of all reporting groups
11184490|NCT02088047|FG000|Participant Flow|Profoveate|The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment.
11184491|NCT02088047|FG001|Participant Flow|NonProFoveate|Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.
11184492|NCT02088047|OG000|Outcome|Profoveate|The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment.
11184493|NCT02088047|OG001|Outcome|NonProFoveate|Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.
11184494|NCT02088047|EG000|Reported Event|Profoveate|The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment.
11184495|NCT02088047|EG001|Reported Event|NonProFoveate|Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.
11184496|NCT02088073|BG000|Baseline|ZS 10 g Three Times Daily (Acute Phase)|Sodium zirconium cyclosilicate (ZS) 10 g, three times daily (TID), orally as a suspension for 48 hours.
11184497|NCT02088073|BG001|Baseline|Placebo Comparator (Maintenance Phase)|Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive.
11184498|NCT02088073|BG002|Baseline|ZS 5 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive.
11184499|NCT02088073|BG003|Baseline|ZS 10 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive.
11184500|NCT02088073|BG004|Baseline|ZS 15 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive.
11184501|NCT02088073|BG005|Baseline|Total|Total of all reporting groups
11184502|NCT02088073|FG000|Participant Flow|ZS 10 g Three Times Daily (Acute Phase)|Sodium zirconium cyclosilicate (ZS) 10 g, three times daily (TID), orally as a suspension for 48 hours.
11184503|NCT02088073|FG001|Participant Flow|Placebo Comparator (Maintenance Phase)|Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive.
11184504|NCT02088073|FG002|Participant Flow|ZS 5 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive.
11184505|NCT02088073|FG003|Participant Flow|ZS 10 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive.
11184506|NCT02088073|FG004|Participant Flow|ZS 15 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive.
11184507|NCT02088073|OG000|Outcome|Placebo Comparator (Maintenance Phase)|Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive.
11184508|NCT02088073|OG001|Outcome|ZS 5 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive.
11184509|NCT02088073|OG002|Outcome|ZS 10 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive.
11184510|NCT02088073|OG003|Outcome|ZS 15 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive.
11184511|NCT02088073|OG000|Outcome|Acute Phase: ZS 10 g TID|ZS (sodium zirconium cyclosilicate) 10 g, three times a day, orally as suspension in water for 48 hours.
11184512|NCT02088073|OG000|Outcome|Acute Phase: ZS 10 g TID|ZS (sodium zirconium cyclosilicate) 10 g, three times a day, orally as a suspension for 48 hours.
11184513|NCT02088073|EG000|Reported Event|ZS 10 g TID (Acute Phase)|ZS (sodium zirconium cyclosilicate) 10 g, three times a day, orally as suspension in water for 48 hours.
11184514|NCT02088073|EG001|Reported Event|Placebo Comparator (Maintenance Phase)|Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive.
11184515|NCT02088073|EG002|Reported Event|ZS 5 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive.
11184516|NCT02088073|EG003|Reported Event|ZS 10 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive.
11184517|NCT02088073|EG004|Reported Event|ZS 15 g Once Daily (Maintenance Phase)|Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive.
11184518|NCT02088177|BG000|Baseline|Open Label Group|open label group receiving injections of long acting naltrexone
11184519|NCT02088177|FG000|Participant Flow|Open Label Group|open label group receiving injections of long acting naltrexone
11184520|NCT02088177|OG000|Outcome|Open Label Group|open label group receiving injections of long acting naltrexone
11184521|NCT02088177|EG000|Reported Event|Open Label Group|open label group receiving injections of long acting naltrexone
11184522|NCT02088216|BG000|Baseline|N-acetylcysteine Group|Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).
11184523|NCT02088216|BG001|Baseline|Control Group|Participants received on-demand treatment.
11184524|NCT02088216|BG002|Baseline|Total|Total of all reporting groups
11184525|NCT02088216|FG000|Participant Flow|N-acetylcysteine Group|Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).
11184526|NCT02088216|FG001|Participant Flow|Control Group|Participants received on-demand treatment.
11184527|NCT02088216|OG000|Outcome|N-acetylcysteine Group|Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).
11184528|NCT02088216|OG001|Outcome|Control Group|Participants received on-demand treatment.
11184529|NCT02088216|EG000|Reported Event|N-acetylcysteine Group|Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).
11184530|NCT02088216|EG001|Reported Event|Control Group|Participants received on-demand treatment.
11184531|NCT02088385|BG000|Baseline|Hemospray|"Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent~Hemospray"
11184532|NCT02088385|BG001|Baseline|Combined Conventional Technique|"Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application~Combined Conventional Technique"
11184533|NCT02088385|BG002|Baseline|Total|Total of all reporting groups
11184534|NCT02088385|FG000|Participant Flow|Hemospray|"Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent~Hemospray"
11184535|NCT02088385|FG001|Participant Flow|Combined Conventional Technique|"Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application~Combined Conventional Technique"
11184536|NCT02088385|OG000|Outcome|Hemospray|"Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent~Hemospray"
11184537|NCT02088385|OG001|Outcome|Combined Conventional Technique|"Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application~Combined Conventional Technique"
11184538|NCT02088385|EG000|Reported Event|Hemospray|"Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent~Hemospray"
11184539|NCT02088385|EG001|Reported Event|Combined Conventional Technique|"Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application~Combined Conventional Technique"
11184540|NCT02088541|BG000|Baseline|Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)|Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184541|NCT02088541|BG001|Baseline|Selinexor 60 mg (PV<5) (Equivalent to 35 mg/m^2)|Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184542|NCT02088541|BG002|Baseline|Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)|Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184543|NCT02088541|BG003|Baseline|Physician's Choice 1 (PV <5)|Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
11184544|NCT02088541|BG004|Baseline|Physician's Choice 2 (PV >=5)|Participants under PV>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
11184545|NCT02088541|BG005|Baseline|Total|Total of all reporting groups
11184546|NCT02088541|FG000|Participant Flow|Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)|Participants under protocol versions (PV) less than (<) 5.0 (those who had one prior line of acute myeloid leukemia (AML) therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (milligrams per square meter) (60 to 120 mg based on body surface area [BSA]) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184547|NCT02088541|FG001|Participant Flow|Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2)|Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184548|NCT02088541|FG002|Participant Flow|Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)|Participants under PV greater than or equal to (>=) 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184549|NCT02088541|FG003|Participant Flow|Physician's Choice 1 (PV <5)|Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
11184550|NCT02088541|FG004|Participant Flow|Physician's Choice 2 (PV >=5)|Participants under PV>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
11184551|NCT02088541|OG000|Outcome|Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)|Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
11184552|NCT02088541|OG001|Outcome|Physician's Choice 2 (PV >=5)|Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
11184553|NCT02088541|OG000|Outcome|Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)|Participants under PV >=5, received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184554|NCT02088541|EG000|Reported Event|Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)|Participants under PV <5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184555|NCT02088541|EG001|Reported Event|Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2)|Participants under PV <5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
11184556|NCT02088541|EG002|Reported Event|Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2)|Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
10961802|NCT00863057|FG002|Participant Flow|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
10961803|NCT00863057|FG003|Participant Flow|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
10961804|NCT00863057|OG000|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
10961805|NCT00863057|OG001|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
10961806|NCT00863057|OG002|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
10961807|NCT00863057|OG003|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
10961808|NCT00863057|OG000|Outcome|Methadone|Maximum tolerated daily dose of Methadone was reported.
10961809|NCT00863057|OG001|Outcome|Duloxetine|Maximum tolerated daily dose of Duloxetine was reported.
10961810|NCT00863057|OG000|Outcome|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
11184557|NCT02088541|EG003|Reported Event|Physician's Choice 1 (PV <5)|Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
11184558|NCT02088541|EG004|Reported Event|Physician's Choice 2 (PV >=5)|Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
11184559|NCT02088697|BG000|Baseline|Arm A: ASC-01 Placebo First|"Period I: A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.~Period II: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting."
11184560|NCT02088697|BG001|Baseline|Arm B: Sertraline First|"Period I: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.~Period II: A single oral dose of ASC-01 placebo (sertraline 100 mg) was administered after 10 or more hours of fasting."
11184561|NCT02088697|BG002|Baseline|Total|Total of all reporting groups
11184562|NCT02088697|FG000|Participant Flow|Arm A: ASC-01 Placebo First|"Period I: A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.~Period II: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting."
11184563|NCT02088697|FG001|Participant Flow|Arm B: Sertraline First|"Period I: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.~Period II: A single oral dose of ASC-01 placebo (sertraline 100 mg) was administered after 10 or more hours of fasting."
11184564|NCT02088697|OG000|Outcome|ASC-01 Placebo|A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.
11184565|NCT02088697|OG001|Outcome|Sertraline|A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.
11184566|NCT02088697|EG000|Reported Event|ASC-01 Placebo|A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.
11184567|NCT02088697|EG001|Reported Event|Sertraline|A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.
11184568|NCT02088788|BG000|Baseline|"Board (Rad Board)"|"Radial artery catheterization is performed using radio-opaque armboard~Board: Also has radio-dense pelvic shielding"
11184569|NCT02088788|BG001|Baseline|No Board|"Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield~No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis"
11184570|NCT02088788|BG002|Baseline|Total|Total of all reporting groups
11184571|NCT02088788|FG000|Participant Flow|"Board (Rad Board)"|"Radial artery catheterization is performed using radio-opaque armboard~Board: Also has radio-dense pelvic shielding"
11184572|NCT02088788|FG001|Participant Flow|No Board|"Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield~No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis"
11184573|NCT02088788|OG000|Outcome|"Board (Rad Board)"|"Radial artery catheterization is performed using radio-opaque armboard~Board: Also has radio-dense pelvic shielding"
11184574|NCT02088788|OG001|Outcome|No Board|"Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield~No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis"
11184575|NCT02088788|EG000|Reported Event|"Board (Rad Board)"|"Radial artery catheterization is performed using radio-opaque armboard~Board: Also has radio-dense pelvic shielding"
11184576|NCT02088788|EG001|Reported Event|No Board|"Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield~No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis"
11184577|NCT02088905|BG000|Baseline|Parent Child Interaction Therapy|"Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group~Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with Autism Spectrum Disorder because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD."
11184578|NCT02088905|BG001|Baseline|Wait List Control|Families will wait 18 weeks for treatment, serving as controls.
11184579|NCT02088905|BG002|Baseline|Total|Total of all reporting groups
11184580|NCT02088905|FG000|Participant Flow|Parent Child Interaction Therapy|"Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group~Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD."
11184581|NCT02088905|FG001|Participant Flow|Wait List Control|Families will wait 18 weeks for treatment, serving as controls.
11184582|NCT02088905|OG000|Outcome|Parent Child Interaction Therapy|"Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group~Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD."
11184583|NCT02088905|OG001|Outcome|Wait List Control|Families will wait 18 weeks for treatment, serving as controls.
11184584|NCT02088905|EG000|Reported Event|Parent Child Interaction Therapy|"Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group~Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD."
11184585|NCT02088905|EG001|Reported Event|Wait List Control|Families will wait 18 weeks for treatment, serving as controls.
11184586|NCT02089113|BG000|Baseline|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone~Dexamethasone"
11184587|NCT02089113|BG001|Baseline|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug~Punctum Plug"
11184588|NCT02089113|BG002|Baseline|Total|Total of all reporting groups
11184589|NCT02089113|FG000|Participant Flow|Dexamethasone Punctum Plug|Drug treatment
11184590|NCT02089113|FG001|Participant Flow|Placebo Vehicle Punctum Plug|No drug treatment
11184591|NCT02089113|OG000|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11184592|NCT02089113|OG001|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
11184593|NCT02089113|EG000|Reported Event|Dexamethasone Punctum Plug|Drug treatment
11184594|NCT02089113|EG001|Reported Event|Placebo Vehicle Punctum Plug|No drug treatment
11184595|NCT02089191|BG000|Baseline|Overall|Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized
11184596|NCT02089191|FG000|Participant Flow|DACP/MyDay|Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2
11184597|NCT02089191|FG001|Participant Flow|MyDay/DACP|Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2
11184598|NCT02089191|OG000|Outcome|DACP|Nelfilcon A contact lenses
11184599|NCT02089191|OG001|Outcome|MyDay|Stenfilcon A contact lenses
11184600|NCT02089191|EG000|Reported Event|DACP|Nelfilcon A contact lenses
11184601|NCT02089191|EG001|Reported Event|MyDay|Stenfilcon A contact lenses
11184602|NCT02089230|BG000|Baseline|Phase I Cohort 1 - MEK 162|Phase I Starting Dose of MEK 162: 30 mg by mouth twice a day in a 28 day cycle.
11184603|NCT02089230|BG001|Baseline|Phase I Cohort 2 - MEK 162|Phase I Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle.
11184604|NCT02089230|BG002|Baseline|Phase II Cohort 3 - MDK 162|Phase II Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle.
11184605|NCT02089230|BG003|Baseline|Total|Total of all reporting groups
11184606|NCT02089230|FG000|Participant Flow|Phase I Cohort 1 - MEK 162|Phase I Starting Dose of MEK 162: 30 mg by mouth twice a day in a 28 day cycle.
11184607|NCT02089230|FG001|Participant Flow|Phase I Cohort 2 - MEK 162|Phase I Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle.
11184608|NCT02089230|FG002|Participant Flow|Phase II Cohort 3 - MDK 162|Phase II Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle.
11184609|NCT02089230|OG000|Outcome|Phase I Cohort 1 - MEK 162|Phase I Starting Dose of MEK 162: 30 mg by mouth twice a day in a 28 day cycle.
11184610|NCT02089230|OG001|Outcome|Phase I Cohort 2 - MEK 162|Phase I Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle.
11184611|NCT02089230|OG002|Outcome|Phase II Cohort 3 - MDK 162|Phase II Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle.
11184612|NCT02089230|EG000|Reported Event|Phase I Cohort 1 - MEK 162|Phase I Starting Dose of MEK 162: 30 mg by mouth twice a day in a 28 day cycle.
11184613|NCT02089230|EG001|Reported Event|Phase I Cohort 2 - MEK 162|Phase I Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle.
11184614|NCT02089230|EG002|Reported Event|Phase II Cohort 3 - MDK 162|Phase II Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle.
11184615|NCT02089334|BG000|Baseline|125 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184616|NCT02089334|BG001|Baseline|200 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 200 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184617|NCT02089334|BG002|Baseline|250 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184618|NCT02089334|BG003|Baseline|250 mg/m^2/Day RX-0201 + Everolimus (Stage 2)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after the determination of MTD in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184619|NCT02089334|BG004|Baseline|Total|Total of all reporting groups
11184620|NCT02089334|FG000|Participant Flow|125 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184621|NCT02089334|FG001|Participant Flow|200 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 200 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184622|NCT02089334|FG002|Participant Flow|250 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184623|NCT02089334|FG003|Participant Flow|250 mg/m^2/Day RX-0201 + Everolimus (Stage 2)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of the maximum tolerated dose in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184624|NCT02089334|OG000|Outcome|125 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184625|NCT02089334|OG001|Outcome|200 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 200 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184626|NCT02089334|OG002|Outcome|250 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184627|NCT02089334|OG000|Outcome|250 mg/m^2/Day RX-0201 + Everolimus (Stage 2)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after the determination of MTD in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184628|NCT02089334|OG000|Outcome|125 mg/m^2/ Day RX-0201 Plus Everolimus (Stage 1)|"RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184629|NCT02089334|OG000|Outcome|125 mg/m^2 RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11236040|NCT02447029|OG000|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
11236041|NCT02447029|OG001|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
11236042|NCT02447029|EG000|Reported Event|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
11236043|NCT02447029|EG001|Reported Event|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
11236044|NCT02447081|BG000|Baseline|Subjects Implanted With Amulet Device|"All subjects who received the Amulet device were followed.~Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device."
11236045|NCT02447081|FG000|Participant Flow|Subjects Implanted With Amulet Device|Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
11236046|NCT02447081|OG000|Outcome|Subjects Implanted With Amulet Device|"All subjects who received the Amulet device were followed.~Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device."
11236047|NCT02447081|EG000|Reported Event|Subjects Implanted With Amulet Device|"All subjects who received the Amulet device were followed.~Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device."
11236048|NCT02447172|BG000|Baseline|Gentamicin Sponge Group|"Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Gentamicin Collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11236049|NCT02447172|BG001|Baseline|Placebo Sponge Group|"Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Placebo: Matching placebo sponge"
11236050|NCT02447172|BG002|Baseline|No Sponge Group|Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
11236051|NCT02447172|BG003|Baseline|Total|Total of all reporting groups
11236052|NCT02447172|FG000|Participant Flow|Gentamicin Sponge Group|"Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Gentamicin Collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11236053|NCT02447172|FG001|Participant Flow|Placebo Sponge Group|"Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Placebo: Matching placebo sponge"
11236054|NCT02447172|FG002|Participant Flow|No Sponge Group|Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
11236055|NCT02447172|OG000|Outcome|Gentamicin Sponge Group|"Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Gentamicin Collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11236056|NCT02447172|OG001|Outcome|Placebo Sponge Group|"Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Placebo: Matching placebo sponge"
11236057|NCT02447172|OG002|Outcome|No Sponge Group|Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
11236058|NCT02447172|EG000|Reported Event|Gentamicin Sponge Group|"Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Gentamicin Collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)"
11236059|NCT02447172|EG001|Reported Event|Placebo Sponge Group|"Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.~Placebo: Matching placebo sponge"
11236060|NCT02447172|EG002|Reported Event|No Sponge Group|Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
11236061|NCT02447250|BG000|Baseline|Single Arm: Varied Albuterol Dose Response|"Subjects will be evaluated in three sessions within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.~Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2"
10847269|NCT00282464|BG000|Baseline|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
10847270|NCT00282464|BG001|Baseline|Placebo|
10847271|NCT00282464|BG002|Baseline|Total|Total of all reporting groups
11184630|NCT02089334|OG003|Outcome|RX-0201 Plus Everolimus (Stage 2)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184631|NCT02089334|EG000|Reported Event|125 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184632|NCT02089334|EG001|Reported Event|200 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 200 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184633|NCT02089334|EG002|Reported Event|250 mg/m^2/Day RX-0201 + Everolimus (Stage 1)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184634|NCT02089334|EG003|Reported Event|RX-0201 Plus Everolimus (Stage 2)|"RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1.~10 mg everolimus was taken daily for a cycle of 21 days"
11184635|NCT02089347|BG000|Baseline|SP306 Group|Participants received SP306 vaccine intramuscularly
11184636|NCT02089347|BG001|Baseline|DT Group|Participants received DT vaccine subcutaneously
11184637|NCT02089347|BG002|Baseline|Total|Total of all reporting groups
11184638|NCT02089347|FG000|Participant Flow|SP306 Group|Participants received SP306 vaccine intramuscularly
11184639|NCT02089347|FG001|Participant Flow|DT Group|Participants received DT vaccine subcutaneously
11184640|NCT02089347|OG000|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
11184641|NCT02089347|OG001|Outcome|DT Group|Participants received DT vaccine subcutaneously
11184642|NCT02089347|EG000|Reported Event|SP306 Group|Participants received SP306 vaccine intramuscularly
11184643|NCT02089347|EG001|Reported Event|DT Group|Participants received DT vaccine subcutaneously
11184644|NCT02089464|BG000|Baseline|NBS-rTMS + Task-oriented Rehabilitation|"NBS-guided rTMS + task-oriented rehabilitation~NBS-guided rTMS~Task oriented rehabilitation"
11184645|NCT02089464|BG001|Baseline|Sham rTMS + Task-oriented Rehabilitation|"Sham rTMS + task-oriented rehabilitation~Sham rTMS~Task oriented rehabilitation"
11184646|NCT02089464|BG002|Baseline|Total|Total of all reporting groups
11184647|NCT02089464|FG000|Participant Flow|NBS-rTMS + Task-oriented Rehabilitation|"NBS-guided rTMS + task-oriented rehabilitation~NBS-guided rTMS~Task oriented rehabilitation"
11184648|NCT02089464|FG001|Participant Flow|Sham rTMS + Task-oriented Rehabilitation|"Sham rTMS + task-oriented rehabilitation~Sham rTMS~Task oriented rehabilitation"
11184649|NCT02089464|OG000|Outcome|NBS-rTMS + Task-oriented Rehabilitation|"NBS-guided rTMS + task-oriented rehabilitation~NBS-guided rTMS~Task oriented rehabilitation"
11184650|NCT02089464|OG001|Outcome|Sham rTMS + Task-oriented Rehabilitation|"Sham rTMS + task-oriented rehabilitation~Sham rTMS~Task oriented rehabilitation"
11184651|NCT02089464|EG000|Reported Event|NBS-rTMS + Task-oriented Rehabilitation|"NBS-guided rTMS + task-oriented rehabilitation~NBS-guided rTMS~Task oriented rehabilitation"
11184652|NCT02089464|EG001|Reported Event|Sham rTMS + Task-oriented Rehabilitation|"Sham rTMS + task-oriented rehabilitation~Sham rTMS~Task oriented rehabilitation"
11184653|NCT02089659|BG000|Baseline|Part 1: Participants With Moderate Hepatic Insufficiency|Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.
11184654|NCT02089659|BG001|Baseline|Part 1: Healthy Control Participants|Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.
11184655|NCT02089659|BG002|Baseline|Total|Total of all reporting groups
11184656|NCT02089659|FG000|Participant Flow|Part 1: Participants With Moderate Hepatic Insufficiency|Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.
11184657|NCT02089659|FG001|Participant Flow|Part 1: Healthy Control Participants|Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.
11184658|NCT02089659|FG002|Participant Flow|Part 2: Participants With Mild Hepatic Insufficiency|Participants with mild hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have mild hepatic insufficiency based on the Child-Pugh scale. This arm was to be enrolled and investigated only if a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1.
11184659|NCT02089659|OG000|Outcome|Part 1: Participants With Moderate Hepatic Insufficiency|Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.
11184660|NCT02089659|OG001|Outcome|Part 1: Healthy Control Participants|Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.
11184661|NCT02089659|EG000|Reported Event|Part 1: Participants With Moderate Hepatic Insufficiency|Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.
11184662|NCT02089659|EG001|Reported Event|Part 1: Healthy Control Participants|Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.
11184663|NCT02089737|BG000|Baseline|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
11184664|NCT02089737|FG000|Participant Flow|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
11184665|NCT02089737|OG000|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
11184666|NCT02089737|EG000|Reported Event|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
11184667|NCT02089737|EG001|Reported Event|Concomitant Administration of Panitumumab and Chemotherapy|
11184668|NCT02089997|BG000|Baseline|Sodium Risedronate 75 mg|Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
11184669|NCT02089997|FG000|Participant Flow|Sodium Risedronate 75 mg|Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
11184670|NCT02089997|OG000|Outcome|Sodium Risedronate 75 mg|Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
11184671|NCT02089997|EG000|Reported Event|Sodium Risedronate 75 mg|Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
11184672|NCT02090075|BG000|Baseline|Apixaban|"apixaban 5 mg or 2.5 mg po bid~apixaban: 5 po or 2.5 po bid."
11184673|NCT02090075|BG001|Baseline|Warfarin|"warfarin with target INR of 2-3~warfarin"
11184674|NCT02090075|BG002|Baseline|Total|Total of all reporting groups
11184675|NCT02090075|FG000|Participant Flow|Apixaban|"apixaban 5 mg or 2.5 mg po bid~apixaban: 5 po or 2.5 po bid."
11184676|NCT02090075|FG001|Participant Flow|Warfarin|"warfarin with target INR of 2-3~warfarin"
11184677|NCT02090075|OG000|Outcome|Apixaban|"apixaban 5 mg or 2.5 mg po bid~apixaban: 5 po or 2.5 po bid."
11184678|NCT02090075|OG001|Outcome|Warfarin|"warfarin with target INR of 2-3~warfarin"
11184679|NCT02090075|EG000|Reported Event|Apixaban|"apixaban 5 mg or 2.5 mg po bid~apixaban: 5 po or 2.5 po bid."
11184680|NCT02090075|EG001|Reported Event|Warfarin|"warfarin with target INR of 2-3~warfarin"
11184681|NCT02090088|BG000|Baseline|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
11184682|NCT02090088|FG000|Participant Flow|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
11184683|NCT02090088|OG000|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
11184684|NCT02090088|EG000|Reported Event|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
11184685|NCT02090088|EG001|Reported Event|Infants|Infants who were born to enrolled participants during the study.
11184686|NCT02090283|BG000|Baseline|Placebo to SD-101-6.0|Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184687|NCT02090283|BG001|Baseline|SD-101-3.0 to SD-101-6.0|Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184688|NCT02090283|BG002|Baseline|SD-101-6.0 to SD-101-6.0|Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184689|NCT02090283|BG003|Baseline|Total|Total of all reporting groups
11184690|NCT02090283|FG000|Participant Flow|Placebo to SD-101-6.0|Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184691|NCT02090283|FG001|Participant Flow|SD-101-3.0 to SD-101-6.0|Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184692|NCT02090283|FG002|Participant Flow|SD-101-6.0 to SD-101-6.0|Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184693|NCT02090283|OG000|Outcome|Placebo to SD-101-6.0|Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184694|NCT02090283|OG001|Outcome|SD-101-3.0 to SD-101-6.0|Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184695|NCT02090283|OG002|Outcome|SD-101-6.0 to SD-101-6.0|Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184696|NCT02090283|EG000|Reported Event|Placebo to SD-101-6.0|Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184697|NCT02090283|EG001|Reported Event|SD-101-3.0 to SD-101-6.0|Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184698|NCT02090283|EG002|Reported Event|SD-101-6.0 to SD-101-6.0|Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
11184699|NCT02090374|BG000|Baseline|Poly ICLC Dose Escalation|Dose esalation within same volunteers: 10ug, 100ug, 500ug
11184700|NCT02090374|BG001|Baseline|Poly ICLC Highest Dose|Single dose: 1000ug
11184701|NCT02090374|BG002|Baseline|Poly I:C Single Dose|Poly I:C nasal challenge single dose: 500ug
11184702|NCT02090374|BG003|Baseline|R848 High Dose|R848 nasal challenge high dose: 10ug
11184703|NCT02090374|BG004|Baseline|R848 Low Dose|R848 nasal challenge low dose: 1-2ug (0.02ug/kg)
11184704|NCT02090374|BG005|Baseline|Grass Pollen|Timothy Grass Pollen nasal challenge: 5000 SQ-U/100µl
11184705|NCT02090374|BG006|Baseline|Vitamin D Supplementation|Vitamin D 4000U oraly daily
11184706|NCT02090374|BG007|Baseline|Tuberculin|Tuberculin PPD nasal challenge
11184707|NCT02090374|BG008|Baseline|Total|Total of all reporting groups
11184708|NCT02090374|FG000|Participant Flow|Poly ICLC Dose Escalation|Poly ICLC nasal challenge dose esalation: 10ug, 100ug, 500ug within same volunteers
11184709|NCT02090374|FG001|Participant Flow|Poly ICLC Highest Dose|Poly ICLC nasal challenge single dose of 1000ug
11184710|NCT02090374|FG002|Participant Flow|Poly I:C Single Dose|Poly I:C nasal challenge single dose 500ug
11184711|NCT02090374|FG003|Participant Flow|R848 High Dose|R848 nasal challenge with high dose 10ug
11184712|NCT02090374|FG004|Participant Flow|R848 Low Dose|R848 nasal challenge low dose 1-2ug (0.02ug/kg)
11184713|NCT02090374|FG005|Participant Flow|Grass Pollen|Timothy Grass Pollen nasal challenge: Dose: 5000 SQ-U/100µl
11184714|NCT02090374|FG006|Participant Flow|Vitamin D Supplementation|Vitamin D 4000U oraly daily
11184715|NCT02090374|FG007|Participant Flow|Tuberculin|Tuberculin PPD nasal challenge
11184716|NCT02090374|OG000|Outcome|Poly ICLC Dose Escalation|Poly ICLC nasal challenge dose escalation: 10ug, 100ug, 500ug
11184717|NCT02090374|OG001|Outcome|Poly ICLC High Dose|Poly ICLC nasal challenge single dose of 1000ug
11184718|NCT02090374|OG002|Outcome|Poly I:C Single Dose|Poly I:C nasal challenge 500ug
11184719|NCT02090374|OG003|Outcome|R848 High Dose|R848 nasal challenge with high dose 10ug
11184720|NCT02090374|OG004|Outcome|R848 Low Dose|R848 nasal challenge low dose 1-2ug (0.02ug/kg)
11184721|NCT02090374|OG005|Outcome|Grass Pollen|Timothy Grass Pollen: Dose: 5000 SQ-U/100µl
11184722|NCT02090374|OG006|Outcome|Vitamin D Supplementation|Vitamin D 4000U oraly daily
11184723|NCT02090374|OG007|Outcome|Tuberculin|Tuberculin PPD nasal challenge
11184724|NCT02090374|EG000|Reported Event|Poly ICLC Dose Escalation|Poly ICLC nasal challenge dose escalation: 10ug, 100ug, 500ug
11184725|NCT02090374|EG001|Reported Event|Poly ICLC Higest Dose|Poly ICLC nasal challenge 1000ug
11184726|NCT02090374|EG002|Reported Event|Poly I:C Single Dose|Poly I:C nasal challenge single dose 500ug
11184727|NCT02090374|EG003|Reported Event|R848 High Dose|R848 high dose 10ug
11184728|NCT02090374|EG004|Reported Event|R848 Low Dose|R848 low dose 1-2ug 0.02ug/kg
11184729|NCT02090374|EG005|Reported Event|Grass Pollen|Timothy Grass Pollen: Dose: 5000 SQ-U/100µl
11184730|NCT02090374|EG006|Reported Event|Vitamin D Supplementation|Vitamin D 4000U oraly daily
11184731|NCT02090374|EG007|Reported Event|Tuberculin|Tuberculin PPD nasal challenge
11184732|NCT02090413|BG000|Baseline|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184733|NCT02090413|BG001|Baseline|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184734|NCT02090413|BG002|Baseline|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184735|NCT02090413|BG003|Baseline|Total|Total of all reporting groups
11184736|NCT02090413|FG000|Participant Flow|DMF + ASA-Placebo BID|Dimethyl fumarate (DMF) 120 mg taken twice daily (BID) for the first 7 days and 240 mg BID from Week 2 through Week 48. Acetylsalicylic acid (ASA)-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184737|NCT02090413|FG001|Participant Flow|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184738|NCT02090413|FG002|Participant Flow|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184739|NCT02090413|OG000|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184740|NCT02090413|OG001|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184741|NCT02090413|OG002|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184742|NCT02090413|OG000|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184743|NCT02090413|EG000|Reported Event|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184744|NCT02090413|EG001|Reported Event|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11184745|NCT02090413|EG002|Reported Event|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
11236062|NCT02447250|FG000|Participant Flow|Single Arm: Varied Albuterol Dose Response|"Subjects will be evaluated in three sessions within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.~Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2"
11236063|NCT02447250|OG000|Outcome|Single Arm: Varied Albuterol Dose Response|"Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.~Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2"
11236064|NCT02447250|OG000|Outcome|Single Arm: Varied Albuterol Dose Response|"Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.~Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to"
11236065|NCT02447250|EG000|Reported Event|Single Arm: Varied Albuterol Dose Response|"Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. Resistance and compliance will be measured using the single breath occlusion technique.~Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to"
11236066|NCT02447302|BG000|Baseline|Etrasimod 1 mg|Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236067|NCT02447302|BG001|Baseline|Etrasimod 2 mg|Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236068|NCT02447302|BG002|Baseline|Placebo|Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236069|NCT02447302|BG003|Baseline|Total|Total of all reporting groups
11236070|NCT02447302|FG000|Participant Flow|Etrasimod 1 mg|Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236071|NCT02447302|FG001|Participant Flow|Etrasimod 2 mg|Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236072|NCT02447302|FG002|Participant Flow|Placebo|Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236073|NCT02447302|OG000|Outcome|Etrasimod 1 mg|Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236074|NCT02447302|OG001|Outcome|Etrasimod 2 mg|Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236075|NCT02447302|OG002|Outcome|Placebo|Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236076|NCT02447302|EG000|Reported Event|Etrasimod 1 mg|Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236077|NCT02447302|EG001|Reported Event|Etrasimod 2 mg|Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236078|NCT02447302|EG002|Reported Event|Placebo|Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
11236079|NCT02447328|BG000|Baseline|Single Arm|fulvestrant (Faslodex®)
11236080|NCT02447328|FG000|Participant Flow|Single Arm|fulvestrant (Faslodex®)
11236081|NCT02447328|OG000|Outcome|Single Arm|fulvestrant (Faslodex®)
11236082|NCT02447328|EG000|Reported Event|Single Arm|fulvestrant (Faslodex®)
11236083|NCT02447432|BG000|Baseline|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).
11236084|NCT02447432|BG001|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of Synflorix™ vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).
11236085|NCT02447432|BG002|Baseline|Total|Total of all reporting groups
11236086|NCT02447432|FG000|Participant Flow|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
11236087|NCT02447432|FG001|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
11236088|NCT02447432|OG000|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
11236089|NCT02447432|OG001|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
11236090|NCT02447432|EG000|Reported Event|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
11236091|NCT02447432|EG001|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
11236092|NCT02447458|BG000|Baseline|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
11236093|NCT02447458|BG001|Baseline|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
11236094|NCT02447458|BG002|Baseline|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236095|NCT02447458|BG003|Baseline|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
11236096|NCT02447458|BG004|Baseline|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
11236097|NCT02447458|BG005|Baseline|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
11236098|NCT02447458|BG006|Baseline|Total|Total of all reporting groups
11236099|NCT02447458|FG000|Participant Flow|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
11236100|NCT02447458|FG001|Participant Flow|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
11236101|NCT02447458|FG002|Participant Flow|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236102|NCT02447458|FG003|Participant Flow|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
11236103|NCT02447458|FG004|Participant Flow|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
11236104|NCT02447458|FG005|Participant Flow|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
11236105|NCT02447458|OG000|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
11236106|NCT02447458|OG001|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
11236107|NCT02447458|OG002|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236108|NCT02447458|OG003|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
11236109|NCT02447458|OG004|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
11236110|NCT02447458|OG005|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
11236111|NCT02447458|OG006|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236112|NCT02447458|OG007|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236113|NCT02447458|OG005|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236114|NCT02447458|EG000|Reported Event|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
11236115|NCT02447458|EG001|Reported Event|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
11236116|NCT02447458|EG002|Reported Event|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236117|NCT02447458|EG003|Reported Event|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
11236118|NCT02447458|EG004|Reported Event|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
11236119|NCT02447458|EG005|Reported Event|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
11236120|NCT02447458|EG006|Reported Event|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236121|NCT02447458|EG007|Reported Event|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
11236122|NCT02447497|BG000|Baseline|3M CHG/IPA - Abdominal Region - Left or Right|Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
11236123|NCT02447497|BG001|Baseline|Normal Saline - Abdominal Region - Left or Right|Saline control was randomly assigned to the left or right side of the abdominal test site
11236124|NCT02447497|BG002|Baseline|3M CHG/IPA Prep - Inguinal Region - Left or Right|Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
11236125|NCT02447497|BG003|Baseline|Normal Saline - Inguinal Region - Left or Right|Saline control was randomly assigned to the left or right side of the inguinal test site
11236126|NCT02447497|BG004|Baseline|Total|Total of all reporting groups
11236127|NCT02447497|FG000|Participant Flow|3M CHG/IPA - Abdominal Region|Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
11236128|NCT02447497|FG001|Participant Flow|Normal Saline - Abdominal Region|Saline control was randomly assigned to the left or right side of the abdominal test site
11236129|NCT02447497|FG002|Participant Flow|3M CHG/IPA Prep - Inguinal Region|Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
11236130|NCT02447497|FG003|Participant Flow|Normal Saline - Inguinal Region|Saline control was randomly assigned to the left or right side of the inguinal test site
11236131|NCT02447497|OG000|Outcome|Normal Saline - Abdominal Region|Saline control was randomly assigned to the left or right side of the abdominal test site
11236132|NCT02447497|OG001|Outcome|3M CHG/IPA Prep - Abdominal Region|Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
11236133|NCT02447497|OG002|Outcome|Normal Saline - Inguinal Region|Saline control was randomly assigned to the left or right side of the inguinal test site
11236134|NCT02447497|OG003|Outcome|3M CHG/IPA Prep - Inguinal Region|Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
11236135|NCT02447497|OG000|Outcome|3M CHG/IPA - Abdominal Area|"Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70%~3M CHG/IPA Surgical Skin Preparation: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%"
11236136|NCT02447497|OG001|Outcome|Normal Saline - Abdominal Area|"0.9% sodium chloride with applicator~Normal Saline: 0.9% sodium chloride applied with foam applicator"
11236137|NCT02447497|OG002|Outcome|3M CHG/IPA - Inguinal Area|"Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70%~3M CHG/IPA Surgical Skin Preparation: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%"
11236138|NCT02447497|OG003|Outcome|Normal Saline - Inguinal Area|"0.9% sodium chloride with applicator~Normal Saline: 0.9% sodium chloride applied with foam applicator"
11236139|NCT02447497|OG000|Outcome|3M CHG/IPA - Abdomen|"Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70%~3M CHG/IPA Surgical Skin Preparation: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%~Applied to the abdominal area"
11236140|NCT02447497|OG001|Outcome|Normal Saline - Abdomen|"0.9% sodium chloride with applicator~Normal Saline: 0.9% sodium chloride applied with foam applicator~Applied to the abdominal area"
11184746|NCT02090426|BG000|Baseline|Standard Care|Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.
11184747|NCT02090426|BG001|Baseline|Link2Care|"Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability.~Link2Care"
11184748|NCT02090426|BG002|Baseline|Total|Total of all reporting groups
11184749|NCT02090426|FG000|Participant Flow|Standard Care|Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.
11184750|NCT02090426|FG001|Participant Flow|Link2Care|"Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including Temporary Assistance for Needy Families (TANF), Supplemental Nutrition Assistance Program (SNAP), and programs that promote housing stability.~Link2Care"
11184751|NCT02090426|OG000|Outcome|Standard Care|Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.
11184752|NCT02090426|OG001|Outcome|Link2Care|"Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability.~Link2Care"
11184753|NCT02090426|EG000|Reported Event|Standard Care|Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.
11184754|NCT02090426|EG001|Reported Event|Link2Care|"Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability.~Link2Care"
11184755|NCT02090634|BG000|Baseline|Personalized Reminder Texting + Psychoeducation (iTAB)|The individualized Texting for Adherence Building (iTAB) intervention is designed to improve adherence to antiretroviral and psychotropic medications for HIV+ persons who have bipolar disorder using automated text message reminders. These text messages will be targeted to the specific medication schedule and needs of the individual. Participants will also receive daily text messages to assesses mood. Additionally, participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications.
11184756|NCT02090634|BG001|Baseline|Psychoeducation (CTRL)|HIV+ persons who have bipolar disorder will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications. Participants will also receive daily text messages to assess mood, but these participants will not receive the medication reminder text messages.
11184757|NCT02090634|BG002|Baseline|Total|Total of all reporting groups
11184758|NCT02090634|FG000|Participant Flow|Personalized Reminder Texting + Psychoeducation (iTAB)|"Individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual.~Psychoeducation: Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood"
11184759|NCT02090634|FG001|Participant Flow|Psychoeducation (CTRL)|Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications. Participants will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
11184760|NCT02090634|OG000|Outcome|Personalized Reminder Texting + Psychoeducation (iTAB)|"Individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual.~Psychoeducation: Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood."
11184761|NCT02090634|OG001|Outcome|Psychoeducation (CTRL)|Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
11184762|NCT02090634|EG000|Reported Event|Personalized Reminder Texting + Psychoeducation (iTAB)|"Individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual.~Psychoeducation: Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood."
11236141|NCT02447497|OG002|Outcome|3M CHG/IPA - Inguinal|"Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70%~3M CHG/IPA Surgical Skin Preparation: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%~Applied to the inguinal area"
11236142|NCT02447497|OG003|Outcome|Normal Saline - Inguinal|"0.9% sodium chloride with applicator~Normal Saline: 0.9% sodium chloride applied with foam applicator~Applied to the inguinal area"
11236143|NCT02447497|EG000|Reported Event|3M CHG/IPA - Abdomen|"Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70%~3M CHG/IPA Surgical Skin Preparation: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%~Applied to the abdominal area"
11236144|NCT02447497|EG001|Reported Event|Normal Saline - Abdomen|"0.9% sodium chloride with applicator~Normal Saline: 0.9% sodium chloride applied with foam applicator~Applied to the abdominal area"
11236145|NCT02447497|EG002|Reported Event|3M CHG/IPA - Inguinal|"Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70%~3M CHG/IPA Surgical Skin Preparation: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%~Applied to the inguinal area"
11236146|NCT02447497|EG003|Reported Event|Normal Saline - Inguinal|"0.9% sodium chloride with applicator~Normal Saline: 0.9% sodium chloride applied with foam applicator~Applied to the inguinal area"
11236147|NCT02447575|BG000|Baseline|MDI Use Evaluation|This was a single-arm study. All participants were instructed to use the MDI with the flow meter to gauge the correctness of use.
11236148|NCT02447575|FG000|Participant Flow|MDI Use Evaluation|"Patients perform metered dose inhaler (MDI) technique, attaching the Cognita electronic flowmeter to show measurements during the MDI use. These are evaluated by study staff prior to an education demonstration. The intervention is a short educational presentation on the correct use of the MDI.~MDI use Evaluation: Subject will demonstrate the use of MDI) with an electronic flowmeter in place before a short education process to demonstrate current use of MDI"
11236149|NCT02447575|OG000|Outcome|MDI Use Evaluation|This was a single-arm study. All participants were instructed to use the MDI with the flow meter to gauge the correctness of use.
11236150|NCT02447575|EG000|Reported Event|Single Arm Study I|This was a single-arm study. All participants were instructed to use the MDI with the flow meter to gauge the correctness of use.
11236151|NCT02447744|BG000|Baseline|Mindfulness Group|"This arm receives an 8-week mindfulness based behavioral intervention program.~Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress."
11236152|NCT02447744|BG001|Baseline|Waitlist Control Group|"This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.~Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress."
11236153|NCT02447744|BG002|Baseline|Total|Total of all reporting groups
11236154|NCT02447744|FG000|Participant Flow|Mindfulness Group|"This arm receives an 8-week mindfulness based behavioral intervention program.~Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress."
11236155|NCT02447744|FG001|Participant Flow|Waitlist Control Group|"This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.~Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress."
11236156|NCT02447744|OG000|Outcome|Mindfulness Group|"This arm receives an 8-week mindfulness based behavioral intervention program.~Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress."
11236157|NCT02447744|OG001|Outcome|Waitlist Control Group|"This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.~Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress."
11236158|NCT02447744|EG000|Reported Event|Mindfulness Group|"This arm receives an 8-week mindfulness based behavioral intervention program.~Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress."
11236159|NCT02447744|EG001|Reported Event|Waitlist Control Group|"This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.~Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress."
11236160|NCT02447848|BG000|Baseline|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
11236161|NCT02447848|FG000|Participant Flow|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
11236162|NCT02447848|OG000|Outcome|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
11236163|NCT02447848|EG000|Reported Event|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
11236164|NCT02447926|BG000|Baseline|Single Arm Study|Leukapheresis. All subjects will receive the same treatment arm.
11240884|NCT02482675|FG002|Participant Flow|Glucose, Then Sodium Caseinate, Then Milk, Then Whey Protein|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11236165|NCT02447926|FG000|Participant Flow|Single Arm Intervention|"Leukapheresis. All subjects will be assigned to the the same intervention arm.~Leukapheresis: Catheter placement will occur for about 1 hour. The research nurse will schedule leukapheresis on the next day following catheter placement.~On the day of leukapheresis, a blood draw will monitor blood counts, kidney function, liver function, and blood clotting ability. Vital signs will be checked three times over the course of intervention.~During the procedure, blood is mixed with anticoagulant and separated (i.e. red blood cells, white blood cells, platelets, and plasma). 1-1.5 cups of white blood cells will be collected. Leukapheresis will last 3-6 hours.~Remaining components, except for 100-200 ml of plasma, are returned through the catheter. Two teaspoons of blood will be drawn to determine when catheter removal can occur. This part of intervention lasts about 2.5-4 hours."
11236166|NCT02447926|OG000|Outcome|Single Arm Intervention|"Leukapheresis. All subjects will be assigned to the the same intervention arm.~Leukapheresis: Catheter placement will occur for about 1 hour. The research nurse will schedule leukapheresis on the next day following catheter placement.~On the day of leukapheresis, a blood draw will monitor blood counts, kidney function, liver function, and blood clotting ability. Vital signs will be checked three times over the course of intervention.~During the procedure, blood is mixed with anticoagulant and separated (i.e. red blood cells, white blood cells, platelets, and plasma). 1-1.5 cups of white blood cells will be collected. Leukapheresis will last 3-6 hours.~Remaining components, except for 100-200 ml of plasma, are returned through the catheter. Two teaspoons of blood will be drawn to determine when catheter removal can occur. This part of intervention lasts about 2.5-4 hours."
11236167|NCT02447926|EG000|Reported Event|Single Arm Treatment|"Leukapheresis. All subjects will receive the same treatment arm.~Leukapheresis: Catheter placement will occur for about 1 hour. The research nurse will schedule leukapheresis on the next day following catheter placement.~On the day of leukapheresis, a blood draw will monitor blood counts, kidney function, liver function, and blood clotting ability. Vital signs will be checked three times over the course of intervention.~During the procedure, blood is mixed with anticoagulant and separated (i.e. red blood cells, white blood cells, platelets, and plasma). 1-1.5 cups of white blood cells will be collected. Leukapheresis will last 3-6 hours.~Remaining components, except for 100-200 ml of plasma, are returned through the catheter. Two teaspoons of blood will be drawn to determine when catheter removal can occur. This part of intervention lasts about 2.5-4 hours."
11236168|NCT02447952|BG000|Baseline|Mega Faros Device + Fast Fix|In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
11236169|NCT02447952|FG000|Participant Flow|Mega Faros Device + Fast Fix|In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
11236170|NCT02447952|OG000|Outcome|Mega Faros Device + Fast Fix|In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
11236171|NCT02447952|EG000|Reported Event|Mega Faros Device + Fast Fix|During Pilot phase,subjects will attend clinic at least once to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). During 48 week Core Study, subjects will attend 5 clinic visits to perform gold standard measures of function (ALS Functional Rating Scale-Revised and Forced Vital Capacity) and perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visits (home monitoring). In between clinic visits, subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period
11236172|NCT02447991|BG000|Baseline|Placebo|During the Treatment Phase, three placebo capsules were administered to each subject, one capsule to be taken during one acute episode, until three episodes are treated with the study drug.
11236173|NCT02447991|BG001|Baseline|Rizatriptan|During the Treatment Phase, three Rizatriptan capsules were administered to each subject, one capsule to be taken during one acute episode, until three episodes are treated with the study drug.
11236174|NCT02447991|BG002|Baseline|Total|Total of all reporting groups
11341446|NCT03682302|BG000|Baseline|Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
11184763|NCT02090634|EG001|Reported Event|Psychoeducation (CTRL)|Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
11184764|NCT02090725|BG000|Baseline|3-4 Diaminopyridine (DAP)|3-4 Diaminopyridine
11184765|NCT02090725|FG000|Participant Flow|3-4 Diaminopyridine (DAP)|"3-4 Diaminopyridine~Treatment will begin with 5mg three time a day. A common final dosage is 15mg four or five time a day, as clinically needed, and if tolerated. The upper limit is a total of 100mg/day."
11184766|NCT02090725|OG000|Outcome|3-4 Diaminopyridine (DAP)|3-4 Diaminopyridine
11184767|NCT02090725|EG000|Reported Event|3-4 Diaminopyridine (DAP)|3-4 Diaminopyridine
11184768|NCT02090764|BG000|Baseline|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
11184769|NCT02090764|BG001|Baseline|Placebo|"Placebo cream~Placebo"
11184770|NCT02090764|BG002|Baseline|Total|Total of all reporting groups
11184771|NCT02090764|FG000|Participant Flow|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
11184772|NCT02090764|FG001|Participant Flow|Placebo|"Placebo cream~Placebo"
11184773|NCT02090764|OG000|Outcome|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
11184774|NCT02090764|OG001|Outcome|Placebo|"Placebo cream~Placebo"
11184775|NCT02090764|EG000|Reported Event|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
11184776|NCT02090764|EG001|Reported Event|Placebo|"Placebo cream~Placebo"
11184777|NCT02090777|BG000|Baseline|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
11184778|NCT02090777|FG000|Participant Flow|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
11184779|NCT02090777|OG000|Outcome|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
11184780|NCT02090777|EG000|Reported Event|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
11184781|NCT02090855|BG000|Baseline|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered.
11184782|NCT02090855|FG000|Participant Flow|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
11184783|NCT02090855|OG000|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
11184784|NCT02090855|OG000|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 30 image interpretations when combining normal and abnormal readings.The Standard of Truth (SoT) is based on no/sparse neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria based on specimens stained with the Bielschowsky silver stain.
11184785|NCT02090855|OG000|Outcome|Percentage of Sensitivity With Abnormal Reads|This is the percent of sensitivity with the Abnormal image interpretations.
11184786|NCT02090855|OG000|Outcome|Percentage of Specificity for Normal Reads|This is the percentage of Specificity with the normal image interpretations.
11184787|NCT02090855|EG000|Reported Event|Flutemetamol (18F)|This study was to assess the PET images only. There was no drug administered in this study.
11184788|NCT02090894|BG000|Baseline|LaserGenesis Treatment|1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size
11184789|NCT02090894|FG000|Participant Flow|UV Light|UV Light (Laser Genesis). 1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size
11184790|NCT02090894|OG000|Outcome|LaserGenesis Treatment|1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size
11184791|NCT02090894|EG000|Reported Event|LaserGenesis Treatment|1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms with a 5 mm spot size
11184792|NCT02090959|BG000|Baseline|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for up to 144 weeks.
11184793|NCT02090959|FG000|Participant Flow|Ataluren|Participants received ataluren suspension orally 3 times a day (TID), 10 milligrams/kilogram (mg/kg) at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for up to 144 weeks.
11184794|NCT02090959|OG000|Outcome|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for up to 144 weeks.
11184795|NCT02090959|EG000|Reported Event|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for up to 144 weeks.
11184796|NCT02091089|BG000|Baseline|755nm Alexandrite Laser|"755nm Alexandrite laser for the treatment of wrinkles~755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles"
11184797|NCT02091089|FG000|Participant Flow|755nm Alexandrite Laser|"755nm Alexandrite laser for the treatment of wrinkles~755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles"
11184798|NCT02091089|OG000|Outcome|755nm Alexandrite Laser|"755nm Alexandrite laser for the treatment of wrinkles~755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles"
11184799|NCT02091089|EG000|Reported Event|755nm Alexandrite Laser|"755nm Alexandrite laser for the treatment of wrinkles~755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles"
11184800|NCT02091102|BG000|Baseline|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles"
11184801|NCT02091102|FG000|Participant Flow|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles"
11184802|NCT02091102|OG000|Outcome|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles"
11184803|NCT02091102|EG000|Reported Event|755nm Alexandrite Laser|"755nm Alexandrite Laser~755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles"
11236175|NCT02447991|FG000|Participant Flow|Placebo|"During the Treatment Phase, three placebo capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug.~Placebo: During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study."
11236176|NCT02447991|FG001|Participant Flow|Rizatriptan|"During the Treatment Phase, three Rizatriptan capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug.~Rizatriptan: During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study."
11236177|NCT02447991|OG000|Outcome|Placebo|Participants were instructed to treat three separate episodes of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.
11236178|NCT02447991|OG001|Outcome|Rizatriptan|Participants were instructed to treat three separate episodes of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
11236179|NCT02447991|OG000|Outcome|Placebo|Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.
11236180|NCT02447991|OG001|Outcome|Rizatriptan|Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
11236181|NCT02447991|OG000|Outcome|Placebo|Participants meeting International Headache Society and International Classification of Vestibular Disorders criteria for vestibular migraine and experiencing at least two attacks documented during the 12-month prospective observation phase of this study were randomized in a 2:1 ratio to rizatriptan versus placebo. Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.
11236182|NCT02447991|OG001|Outcome|Rizatriptan|Participants meeting International Headache Society and International Classification of Vestibular Disorders criteria for vestibular migraine and experiencing at least two attacks documented during the 12-month prospective observation phase of this study were randomized in a 2:1 ratio to rizatriptan versus placebo. Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
11236183|NCT02447991|EG000|Reported Event|Placebo|"During the Treatment Phase, three placebo capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug.~Placebo: During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study."
11236184|NCT02447991|EG001|Reported Event|Rizatriptan|"During the Treatment Phase, three Rizatriptan capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug.~Rizatriptan: During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study."
11236185|NCT02448043|BG000|Baseline|Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo|"Bimatoprost 0.01% drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.~Saline solution drops placed on the proximal nail folds of the left hand digits two times per day for 30 days"
11236186|NCT02448043|BG001|Baseline|Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo|"Bimatoprost 0.01% drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.~Saline solution drops placed on the proximal nail folds of the right hand digits two times per day for 30 days."
11236187|NCT02448043|BG002|Baseline|Total|Total of all reporting groups
11236188|NCT02448043|FG000|Participant Flow|Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo|"Bimatoprost 0.01% drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.~Saline solution drops placed on the proximal nail folds of the left hand digits two times per day for 30 days."
11236189|NCT02448043|FG001|Participant Flow|Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo|"Bimatoprost 0.01% drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.~Saline solution drops placed on the proximal nail folds of the right hand digits two times per day for 30 days."
11236190|NCT02448043|OG000|Outcome|Bimatoprost 0.01% Drops|Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
11236191|NCT02448043|OG001|Outcome|Placebo|Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
11236192|NCT02448043|OG000|Outcome|Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo|"Bimatoprost 0.01% drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.~Saline solution drops placed on the proximal nail folds of the left hand digits two times per day for 30 days"
11236193|NCT02448043|OG001|Outcome|Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo|"Bimatoprost 0.01% drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.~Saline solution drops placed on the proximal nail folds of the right hand digits two times per day for 30 days."
11236194|NCT02448043|OG000|Outcome|Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo|"Bimatoprost 0.01% drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.~Saline solution drops placed on the proximal nail folds of the left hand digits two times per day for 30 days."
11236195|NCT02448043|EG000|Reported Event|Bimatoprost 0.01% Drops|Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
10847272|NCT00282464|FG000|Participant Flow|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
10847273|NCT00282464|FG001|Participant Flow|Placebo|
11236196|NCT02448043|EG001|Reported Event|Placebo|Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
11236197|NCT02448303|BG000|Baseline|Arm 1 - Pembrolizumab Monotherapy|Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11236198|NCT02448303|BG001|Baseline|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11184804|NCT02091167|BG000|Baseline|Real tDCS|"Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).~transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes."
11184805|NCT02091167|BG001|Baseline|Sham-tDCS|"Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 30 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.~transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes."
11184806|NCT02091167|BG002|Baseline|Total|Total of all reporting groups
11184807|NCT02091167|FG000|Participant Flow|Real tDCS|"Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).~transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes."
11184808|NCT02091167|FG001|Participant Flow|Sham-tDCS|"Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 30 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.~transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes."
11184809|NCT02091167|OG000|Outcome|Real-tDCS|Crack-cocaine patients who underwent 10 sessions of real tDCS treatment.
11184810|NCT02091167|OG001|Outcome|Sham-tDCS|Crack-cocaine patients who underwent sham (placebo)-tDCS control procedure.
11184811|NCT02091167|EG000|Reported Event|Real-tDCS|Crack-cocaine patients who underwent 10 sessions of real tDCS treatment.
11184812|NCT02091167|EG001|Reported Event|Sham-tDCS|Crack-cocaine patients who underwent sham (placebo)-tDCS control procedure.
11184813|NCT02091206|BG000|Baseline|GWP42003-P 5 mg/kg/Day Dose|Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184814|NCT02091206|BG001|Baseline|GWP42003-P 10 mg/kg/Day Dose|Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184815|NCT02091206|BG002|Baseline|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184816|NCT02091206|BG003|Baseline|Placebo|Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
11184817|NCT02091206|BG004|Baseline|Total|Total of all reporting groups
11184818|NCT02091206|FG000|Participant Flow|GWP42003-P 5 mg/kg/Day Dose|Participants received GWP42003-P 5 milligrams (mg) per kilogram (kg) per day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184819|NCT02091206|FG001|Participant Flow|GWP42003-P 10 mg/kg/Day Dose|Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184820|NCT02091206|FG002|Participant Flow|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11236199|NCT02448303|BG002|Baseline|Total|Total of all reporting groups
11184821|NCT02091206|FG003|Participant Flow|Placebo|Participants received placebo (0 mg/milliliter [mL] cannabidiol [CBD]), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched investigational medicinal product (IMP) group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
11236200|NCT02448303|FG000|Participant Flow|Arm 1 - Pembrolizumab Monotherapy|Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11236201|NCT02448303|FG001|Participant Flow|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11236202|NCT02448303|OG000|Outcome|Arm 1 - Pembrolizumab Monotherapy|Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11236203|NCT02448303|OG001|Outcome|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11236204|NCT02448303|EG000|Reported Event|Arm 1 - Pembrolizumab Monotherapy|Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11236205|NCT02448303|EG001|Reported Event|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11236206|NCT02448368|BG000|Baseline|Cohort 1|Treatment A: RDEA3170 capsules, 5 mg (FN24), administered in the fasted state. Treatment B: RDEA3170 capsules, 5 mg FN24, administered in the fed state (high-fat, high-calorie meal). Treatment C: RDEA3170 capsules, 10 mg (FN25), administered in the fasted state. Treatment D: RDEA3170 capsules, 10 mg FN25, administered in the fed state (high-fat, high-calorie meal). Treatment E: RDEA3170 tablets, 2.5 mg FN17, administered as 10 mg (4 × 2.5 mg), in the fasted state.
11236207|NCT02448368|BG001|Baseline|Cohort 3 (Optional)|"Treatment I: RDEA3170 capsules, 10 mg (FN26), administered in the fasted state. Treatment J: RDEA3170 capsules, 10 mg FN26, administered in the fed state (high-fat, high-calorie meal).~Treatment K: RDEA3170 tablets, 2.5 mg FN17, administered as 10 mg (4 × 2.5 mg), in the fasted state"
11236208|NCT02448368|BG002|Baseline|Total|Total of all reporting groups
11236209|NCT02448368|FG000|Participant Flow|Cohort 1: Sequence ABECD (Days 1, 5, 9, 13, and 17)|5 mg FN24 capsules, fasted; 5 mg FN24 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fasted; 10 mg FN25 capsules, fed
11236210|NCT02448368|FG001|Participant Flow|Cohort 1: Sequence AEBDC (Days 1, 5, 9, 13, and 17)|5 mg FN24 capsules, fasted; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fed; 10 mg FN25 capsules, fasted
11236211|NCT02448368|FG002|Participant Flow|Cohort 1: Sequence EADBC (Days 1, 5, 9, 13, and 17)|10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fasted
11236212|NCT02448368|FG003|Participant Flow|Cohort 1: Sequence EDACB (Days 1, 5, 9, 13, and 17)|10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fed
11236213|NCT02448368|FG004|Participant Flow|Cohort 1: Sequence DECAB (Days 1, 5, 9, 13, and 17)|10 mg FN25 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fasted; 5 mg FN24 capsules, fed
11236214|NCT02448368|FG005|Participant Flow|Cohort 1: Sequence BACED (Days 1, 5, 9, 13, and 17)|5 mg FN24 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fasted; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fed
11236215|NCT02448368|FG006|Participant Flow|Cohort 1: Sequence BCADE (Days 1, 5, 9, 13, and 17)|5 mg FN24 capsules, fed; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fed; 10 mg FN17 tablets, fasted
11236216|NCT02448368|FG007|Participant Flow|Cohort 1: Sequence CBDAE (Days 1, 5, 9, 13, and 17)|10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN17 tablets, fasted
11236217|NCT02448368|FG008|Participant Flow|Cohort 1: Sequence CDBEA (Days 1, 5, 9, 13, and 17)|10 mg FN25 capsules, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fed; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fasted
11236218|NCT02448368|FG009|Participant Flow|Cohort 1: Sequence DCEBA (Days 1, 5, 9, 13, and 17)|10 mg FN25 capsules, fed; 10 mg FN25 capsules, fasted; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fed; 5 mg FN24 capsules, fasted
11236219|NCT02448368|FG010|Participant Flow|Cohort 3: Sequence IJK (Days 1, 5, and 9)|10 mg FN26 capsules, fasted; 10 mg FN26 capsules, fed; 10 mg FN17 tablets, fasted
11236220|NCT02448368|FG011|Participant Flow|Cohort 3: Sequence JKI (Days 1, 5, and 9)|10 mg FN26 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN26 capsules, fasted
11236221|NCT02448368|FG012|Participant Flow|Cohort 3: Sequence KIJ (Days 1, 5, and 9)|10 mg FN17 tablets, fasted; 10 mg FN26 capsules, fasted; 10 mg FN26 capsules, fed
11236222|NCT02448368|OG000|Outcome|Treatment A|Verinurad capsules, 5 mg (FN24), administered in the fasted state.
11236223|NCT02448368|OG001|Outcome|Treatment C|Verinurad capsules, 10 mg (FN25), administered in the fasted state.
11236224|NCT02448368|OG002|Outcome|Treatment E|RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
11236225|NCT02448368|OG003|Outcome|Treatment I|RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
11236226|NCT02448368|OG004|Outcome|Treatment K|RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
11236227|NCT02448368|OG001|Outcome|Treatment B|RDEA3170 capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal).
11236228|NCT02448368|OG002|Outcome|Treatment C|Verinurad capsules, 10 mg (FN25), administered in the fasted state.
11236229|NCT02448368|OG003|Outcome|Treatment D|RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal)
11236230|NCT02448368|OG004|Outcome|Treatment E|RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
11236231|NCT02448368|OG005|Outcome|Treatment I|RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
11236232|NCT02448368|OG006|Outcome|Treatment J|RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
11236233|NCT02448368|OG007|Outcome|Treatment K|RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
11357683|NCT03748992|BG000|Baseline|Inhaled Nitric Oxide (gNO)|"Participants will be treated for 3 weeks (5 days per week), Monday through Friday, and followed monthly for 3 months.~The treatment period includes a physical exam, vital signs, blood tests, echocardiogram, spirometry test, sputum sample, questionnaires, and the inhalation gas treatment. During the inhalation gas treatment, participants will wear a face mask (similar to an oxygen mask) and will be given nitric oxide gas through the participants nose for three treatments with fifty minutes each time. They will then be followed up monthly during the Follow-up period with tests that include a physical exam and questionnaires."
11357684|NCT03748992|FG000|Participant Flow|Inhaled Nitric Oxide (gNO)|"Participants will be treated for 3 weeks (5 days per week), Monday through Friday, and followed monthly for 3 months.~The treatment period includes a physical exam, vital signs, blood tests, echocardiogram, spirometry test, sputum sample, questionnaires, and the inhalation gas treatment. During the inhalation gas treatment, participants will wear a face mask (similar to an oxygen mask) and will be given nitric oxide gas through the participants nose for three treatments with fifty minutes each time. They will then be followed up monthly during the Follow-up period with tests that include a physical exam and questionnaires."
11357685|NCT03748992|OG000|Outcome|Inhaled Nitric Oxide (gNO)|"Participants will be treated for 3 weeks (5 days per week), Monday through Friday, and followed monthly for 3 months.~The treatment period includes a physical exam, vital signs, blood tests, echocardiogram, spirometry test, sputum sample, questionnaires, and the inhalation gas treatment. During the inhalation gas treatment, participants will wear a face mask (similar to an oxygen mask) and will be given nitric oxide gas through the participants nose for three treatments with fifty minutes each time. They will then be followed up monthly during the Follow-up period with tests that include a physical exam and questionnaires."
11357686|NCT03748992|EG000|Reported Event|Inhaled Nitric Oxide (gNO)|"evaluate the efficacy and safety of open-label exposure of gNO in patients with NTM lung disease~gNO: This is a proof-of-concept study in which all subjects will be treated with gNO (i.e. no control) to see if there can be a microbiological effect by conversion to negative sputum cultures and how long that effect can be sustained following treatment."
11357687|NCT03748979|BG000|Baseline|Part A, Cohorts A1-A3: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357688|NCT03748979|BG001|Baseline|Part A, Cohort A1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357689|NCT03748979|BG002|Baseline|Part A, Cohort A2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357690|NCT03748979|BG003|Baseline|Part A, Cohort A3: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357691|NCT03748979|BG004|Baseline|Part B, Cohorts B1-B2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357692|NCT03748979|BG005|Baseline|Part B, Cohort B1: TAK-925 11 mg|TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357693|NCT03748979|BG006|Baseline|Part B, Cohort B2: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
10847274|NCT00282464|OG000|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
10847275|NCT00282464|OG001|Outcome|Placebo|
11357694|NCT03748979|BG007|Baseline|Part C, Cohorts C1-C2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357695|NCT03748979|BG008|Baseline|Part C, Cohort C1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357696|NCT03748979|BG009|Baseline|Part C, Cohort C2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357697|NCT03748979|BG010|Baseline|Part A', Cohort A'1: TAK-925 112 mg|TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
11357698|NCT03748979|BG011|Baseline|Total|Total of all reporting groups
11357699|NCT03748979|FG000|Participant Flow|Part A, Cohorts A1-A3: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357700|NCT03748979|FG001|Participant Flow|Part A, Cohort A1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357701|NCT03748979|FG002|Participant Flow|Part A, Cohort A2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357702|NCT03748979|FG003|Participant Flow|Part A, Cohort A3: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357703|NCT03748979|FG004|Participant Flow|Part B, Cohorts B1-B2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in narcolepsy type 1 (NT1) participants.
11357704|NCT03748979|FG005|Participant Flow|Part B, Cohort B1: TAK-925 11 mg|TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357705|NCT03748979|FG006|Participant Flow|Part B, Cohort B2: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357706|NCT03748979|FG007|Participant Flow|Part C, Cohorts C1-C2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in narcolepsy type 2 (NT2) participants.
11357707|NCT03748979|FG008|Participant Flow|Part C, Cohort C1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357708|NCT03748979|FG009|Participant Flow|Part C, Cohort C2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357709|NCT03748979|FG010|Participant Flow|Part A', Cohort A'1: TAK-925 112 mg|TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
11357710|NCT03748979|OG000|Outcome|Part A, Cohorts A1-A3: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11184822|NCT02091206|OG000|Outcome|GWP42003-P 5 mg/kg/Day Dose|Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184823|NCT02091206|OG001|Outcome|GWP42003-P 10 mg/kg/Day Dose|Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184824|NCT02091206|OG002|Outcome|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184825|NCT02091206|OG003|Outcome|Placebo|Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
11184826|NCT02091206|EG000|Reported Event|GWP42003-P 5 mg/kg/Day Dose|Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184827|NCT02091206|EG001|Reported Event|GWP42003-P 10 mg/kg/Day Dose|Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184828|NCT02091206|EG002|Reported Event|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
11184829|NCT02091206|EG003|Reported Event|Placebo|Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
11184830|NCT02091284|BG000|Baseline|Real tDCS|"Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).~transcranial Direct Current Stimulation: Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes."
11184831|NCT02091284|BG001|Baseline|Sham-tDCS|Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 20 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
11184832|NCT02091284|BG002|Baseline|Total|Total of all reporting groups
11184833|NCT02091284|FG000|Participant Flow|Real tDCS|"Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).~transcranial Direct Current Stimulation: Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes."
11184834|NCT02091284|FG001|Participant Flow|Sham-tDCS|Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 20 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
11236234|NCT02448368|OG004|Outcome|Treatment I|RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
11236235|NCT02448368|OG005|Outcome|Treatment J|RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
11236236|NCT02448368|OG007|Outcome|Treatmnet K|RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
11236237|NCT02448368|EG000|Reported Event|Treatment A|Verinurad capsules, 5 mg (FN24), administered in the fasted state.
11236238|NCT02448368|EG001|Reported Event|Treatment B|Verinurad capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal).
11236239|NCT02448368|EG002|Reported Event|Treatment C|Verinurad capsules, 10 mg (FN25), administered in the fasted state.
11236240|NCT02448368|EG003|Reported Event|Treatment D|RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal)
11236241|NCT02448368|EG004|Reported Event|Treatment E|RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
11236242|NCT02448368|EG005|Reported Event|Treatment I|Verinurad capsules, 10 mg (FN26), administered in the fasted state.
11236243|NCT02448368|EG006|Reported Event|Treatment J|Verinurad capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
11236244|NCT02448368|EG007|Reported Event|Treatment K|Verinurad tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
11236245|NCT02448446|BG000|Baseline|Diabetic Macular Edema Treatment Group (Group 1)|"Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.~ranibizumab 0.3mg: intravitreally administered"
11236246|NCT02448446|BG001|Baseline|Diabetic Macular Edema and Lipid Treatment Group (Group 2)|"Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.~ranibizumab 0.3mg: intravitreally administered"
11236247|NCT02448446|BG002|Baseline|Total|Total of all reporting groups
11236248|NCT02448446|FG000|Participant Flow|Diabetic Macular Edema Treatment Group (Group 1)|"Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.~ranibizumab 0.3mg: intravitreally administered"
11236249|NCT02448446|FG001|Participant Flow|Diabetic Macular Edema and Lipid Treatment Group (Group 2)|"Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.~ranibizumab 0.3mg: intravitreally administered"
11236250|NCT02448446|OG000|Outcome|Diabetic Macular Edema Treatment Group (Group 1)|"Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.~ranibizumab 0.3mg: intravitreally administered"
11236251|NCT02448446|OG001|Outcome|Diabetic Macular Edema and Lipid Treatment Group (Group 2)|"Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.~ranibizumab 0.3mg: intravitreally administered"
11236252|NCT02448446|EG000|Reported Event|Diabetic Macular Edema Treatment Group (Group 1)|"Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.~ranibizumab 0.3mg: intravitreally administered"
11236253|NCT02448446|EG001|Reported Event|Diabetic Macular Edema and Lipid Treatment Group (Group 2)|"Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.~ranibizumab 0.3mg: intravitreally administered"
11236254|NCT02448537|BG000|Baseline|PM01183 and Doxorubicin|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
11236255|NCT02448537|BG001|Baseline|PM01183 and Gemcitabine|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
11236256|NCT02448537|BG002|Baseline|Single Agent PM01183|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
11236257|NCT02448537|BG003|Baseline|Total|Total of all reporting groups
11236258|NCT02448537|FG000|Participant Flow|PM01183 and Doxorubicin|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
11236259|NCT02448537|FG001|Participant Flow|PM01183 and Gemcitabine|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
11236260|NCT02448537|FG002|Participant Flow|Single Agent PM01183|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
11236261|NCT02448537|OG000|Outcome|PM01183 and Doxorubicin|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
11236262|NCT02448537|OG001|Outcome|PM01183 and Gemcitabine|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
11236263|NCT02448537|OG002|Outcome|Single Agent PM01183|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
11236264|NCT02448537|EG000|Reported Event|Stratum A|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
11236265|NCT02448537|EG001|Reported Event|Stratum B|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
11236266|NCT02448537|EG002|Reported Event|Stratum C|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
11236267|NCT02448563|BG000|Baseline|Intervention Completers|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
11236268|NCT02448563|BG001|Baseline|Intervention Non-completers|"Non-completers~Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
11236269|NCT02448563|BG002|Baseline|Control Completers|Standard of care - one counseling visit with a study dietitian
11236270|NCT02448563|BG003|Baseline|Control Non-completers|"Non-completers~Standard of care - one counseling visit with a study dietitian"
11236271|NCT02448563|BG004|Baseline|Total|Total of all reporting groups
11236272|NCT02448563|FG000|Participant Flow|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
11236273|NCT02448563|FG001|Participant Flow|Control|Standard of care - one counseling visit with a study dietitian
11236274|NCT02448563|OG000|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
11236275|NCT02448563|OG001|Outcome|Control|Standard of care - one counseling visit with a study dietitian
11236276|NCT02448563|OG000|Outcome|Intervention Completers|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
11236277|NCT02448563|OG001|Outcome|Intervention Non-completers|"Non-completers~Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
11236278|NCT02448563|OG002|Outcome|Control Completers|Standard of care - one counseling visit with a study dietitian
11236279|NCT02448563|OG003|Outcome|Control Non-completers|"Non-completers~Standard of care - one counseling visit with a study dietitian"
11236280|NCT02448563|EG000|Reported Event|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
11236281|NCT02448563|EG001|Reported Event|Control|Standard of care - one counseling visit with a study dietitian
11236282|NCT02448641|BG000|Baseline|SB623 Implant (2.5M)|2.5 million SB623 cells
11236283|NCT02448641|BG001|Baseline|SB623 Implant (5.0M)|5 million SB623 cells
11236284|NCT02448641|BG002|Baseline|Sham Control|Control Group: Sham surgery
11236285|NCT02448641|BG003|Baseline|Total|Total of all reporting groups
11236286|NCT02448641|FG000|Participant Flow|SB623 Implant (2.5M)|"2.5 million SB623 cells~SB623 Implant (2.5M): 2.5 million SB623 cells"
11236287|NCT02448641|FG001|Participant Flow|SB623 Implant (5.0M)|"5 million SB623 cells~SB623 Implant (5.0M): 5 million SB623 cells"
11236288|NCT02448641|FG002|Participant Flow|Sham Control|Control Group: Sham surgery
11236289|NCT02448641|OG000|Outcome|SB623 Implant (2.5M)|"2.5 million SB623 cells~SB623 Implant (2.5M): 2.5 million SB623 cells"
11236290|NCT02448641|OG001|Outcome|SB623 Implant (5.0M)|"5 million SB623 cells~SB623 Implant (5.0M): 5 million SB623 cells"
11236291|NCT02448641|OG002|Outcome|Sham Control|"Sham surgery~Sham surgery"
11236292|NCT02448641|OG000|Outcome|SB623 Implant (2.5M)|2.5 million SB623 cells
11236293|NCT02448641|OG001|Outcome|SB623 Implant (5.0M)|5 million SB623 cells
11236294|NCT02448641|OG002|Outcome|Sham Control|Sham surgery Group
11236295|NCT02448641|OG002|Outcome|Sham Control|Sham surgery Group (Control)
11236296|NCT02448641|OG000|Outcome|SB623 Implant (2.5 M)|2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells
11236297|NCT02448641|OG001|Outcome|SB623 Implant (5.0M)|5.0 million SB623 cells SB623 Implant (5.0M): 5.0 million SB623 cells
11236298|NCT02448641|OG002|Outcome|Sham Surgery|Sham surgery: Control Group
11236299|NCT02448641|EG000|Reported Event|SB623 Implant (2.5M)|"2.5 million SB623 cells~SB623 Implant (2.5M): 2.5 million SB623 cells"
11236300|NCT02448641|EG001|Reported Event|SB623 Implant (5.0M)|"5 million SB623 cells~SB623 Implant (5.0M): 5 million SB623 cells"
11236301|NCT02448641|EG002|Reported Event|Sham Control|Control Group: Sham surgery Group
11236302|NCT02448654|BG000|Baseline|Tolcapone|100mg tolcapone three times a day for 7 days then 100mg once a day on day 8
11236303|NCT02448654|BG001|Baseline|Sugar Pill|Sugar pill (placebo) three times a day for 7 days then once on day 8
11236304|NCT02448654|BG002|Baseline|Total|Total of all reporting groups
11236305|NCT02448654|FG000|Participant Flow|Tolcapone|100mg tolcapone three times a day for 7 days then 100mg once a day on day 8
11236306|NCT02448654|FG001|Participant Flow|Sugar Pill|Sugar pill (placebo) three times a day for 7 days then once on day 8
11236307|NCT02448654|OG000|Outcome|Tolcapone|100mg tolcapone three times a day for 7 days then 100mg once a day on day 8
11236308|NCT02448654|OG001|Outcome|Sugar Pill|Sugar pill (placebo) three times a day for 7 days then once on day 8
11236309|NCT02448654|EG000|Reported Event|Tolcapone|100mg tolcapone three times a day for 7 days then 100mg once a day on day 8
11236310|NCT02448654|EG001|Reported Event|Sugar Pill|Sugar pill (placebo) three times a day for 7 days then once on day 8
11236311|NCT02448706|BG000|Baseline|All Study Participants|All study participants received the same baseline measures, regardless of the hearing aid fitting order to which they were randomized
11236312|NCT02448706|FG000|Participant Flow|Hearing Aid Fitting Order A|High level of signal manipulation (5 weeks), then low level of signal manipulation (5 weeks)
11236313|NCT02448706|FG001|Participant Flow|Hearing Aid Fitting Order B|Low level of signal manipulation (5 weeks), then high level of signal manipulation (5 weeks)
11236314|NCT02448706|OG000|Outcome|High Level of Signal Manipulation|Fit with hearing aids set to a high level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
11236315|NCT02448706|OG001|Outcome|Low Level of Signal Manipulation|Fit with hearing aids set to a low level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
11236316|NCT02448706|OG000|Outcome|Hearing Aid Fitting A|"High level of signal manipulation~Hearing Aid Fitting A"
11236317|NCT02448706|OG001|Outcome|Hearing Aid Fitting B|"Low level of signal manipulation~Hearing Aid Fitting B"
11236318|NCT02448706|EG000|Reported Event|Hearing Aid Fitting A|High level of signal manipulation
11236319|NCT02448706|EG001|Reported Event|Hearing Aid Fitting B|Low level of signal manipulation
11236320|NCT02448719|BG000|Baseline|Cohort 1a-6a: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236321|NCT02448719|BG001|Baseline|Cohort 1a: TAK-792 30 mg|TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236322|NCT02448719|BG002|Baseline|Cohort 2a: TAK-792 100 mg|TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236323|NCT02448719|BG003|Baseline|Cohort 3a: TAK-792 250 mg|TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236324|NCT02448719|BG004|Baseline|Cohort 4a: TAK-792 500 mg|TAK-792 500 mg, tablets, orally, once in fasted state (4a-1) on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fed state (4a-2) on Day 1 of another 5-day treatment period.
11236325|NCT02448719|BG005|Baseline|Cohort 5a: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state (5a-1), once on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fasted state (5a-2) on Day 1 of another 5-day treatment period.
11236326|NCT02448719|BG006|Baseline|Cohort 6a: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236327|NCT02448719|BG007|Baseline|Cohort 4b-6b: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236328|NCT02448719|BG008|Baseline|Cohort 4b: TAK-792 500 mg|TAK-792 500 mg, tablets, orally, once in fasted state (4b-1) on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fed state (4b-2) on Day 1 of another 5-day treatment period.
11236329|NCT02448719|BG009|Baseline|Cohort 5b: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state (5b-1), once on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fasted state (5b-2) on Day 1 of another 5-day treatment period.
11236330|NCT02448719|BG010|Baseline|Cohort 6b: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236331|NCT02448719|BG011|Baseline|Total|Total of all reporting groups
11236332|NCT02448719|FG000|Participant Flow|Cohort 1a-6a: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236333|NCT02448719|FG001|Participant Flow|Cohort 1a: TAK-792 30 mg|TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236334|NCT02448719|FG002|Participant Flow|Cohort 2a: TAK-792 100 mg|TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236335|NCT02448719|FG003|Participant Flow|Cohort 3a: TAK-792 250 mg|TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236336|NCT02448719|FG004|Participant Flow|Cohort 4a: TAK-792 500 mg|TAK-792 500 mg, tablets, orally, once in fasted state (4a-1) on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fed state (4a-2) on Day 1 of another 5-day treatment period.
11236337|NCT02448719|FG005|Participant Flow|Cohort 5a: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state (5a-1), once on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fasted state (5a-2) on Day 1 of another 5-day treatment period.
11236338|NCT02448719|FG006|Participant Flow|Cohort 6a: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236339|NCT02448719|FG007|Participant Flow|Cohort 4b-6b: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236340|NCT02448719|FG008|Participant Flow|Cohort 4b: TAK-792 500 mg|TAK-792 500 mg, tablets, orally, once in fasted state (4b-1) on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fed state (4b-2) on Day 1 of another 5-day treatment period.
11236341|NCT02448719|FG009|Participant Flow|Cohort 5b: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state (5b-1), once on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fasted state (5b-2) on Day 1 of another 5-day treatment period.
11236342|NCT02448719|FG010|Participant Flow|Cohort 6b: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236343|NCT02448719|OG000|Outcome|Cohort 1a-6a: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236344|NCT02448719|OG001|Outcome|Cohort 1a: TAK-792 30 mg|TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236345|NCT02448719|OG002|Outcome|Cohort 2a: TAK-792 100 mg|TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236346|NCT02448719|OG003|Outcome|Cohort 3a: TAK-792 250 mg|TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236347|NCT02448719|OG004|Outcome|Cohort 4a-1: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
11236348|NCT02448719|OG005|Outcome|Cohort 5a-1: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
11236349|NCT02448719|OG006|Outcome|Cohort 6a: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236350|NCT02448719|OG007|Outcome|Cohort 4a-2: Placebo|TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236351|NCT02448719|OG008|Outcome|Cohort 4a-2: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236352|NCT02448719|OG009|Outcome|Cohort 5a-2: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
11236353|NCT02448719|OG010|Outcome|Cohort 5a-2: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
11236354|NCT02448719|OG011|Outcome|Cohort 4b-1 - 6b: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11184835|NCT02091284|OG000|Outcome|Real tDCS|"Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).~transcranial Direct Current Stimulation: Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes."
11184836|NCT02091284|OG001|Outcome|Sham-tDCS|Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 20 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
11184837|NCT02091284|OG000|Outcome|Real tDCS|Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).
11184838|NCT02091284|OG001|Outcome|Sham-tDCS|Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right).
11184839|NCT02091284|EG000|Reported Event|Real tDCS|"Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).~transcranial Direct Current Stimulation: Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes."
11184840|NCT02091284|EG001|Reported Event|Sham-tDCS|Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 20 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
11184841|NCT02091362|BG000|Baseline|LY2409021 20 mg|Period 1: Single daily dose of 20 mg LY2409021 administered orally for 6 Weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.
11184842|NCT02091362|BG001|Baseline|Placebo|Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 mg Ly2409021 administered orally for 6 weeks.
11184843|NCT02091362|BG002|Baseline|Total|Total of all reporting groups
11184844|NCT02091362|FG000|Participant Flow|LY2409021/Placebo|Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.
11184845|NCT02091362|FG001|Participant Flow|Placebo/LY2409021|Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
11184846|NCT02091362|OG000|Outcome|LY2409021 20 mg|Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
11184847|NCT02091362|OG001|Outcome|Placebo|Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
11184848|NCT02091362|OG000|Outcome|LY2409021 20 mg|Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods.
11184849|NCT02091362|OG001|Outcome|Placebo|Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods.
11184850|NCT02091362|EG000|Reported Event|LY2409021 20 mg|AEs (Adverse Event) from Period 1 and 2 combined from LY2409021 20 mg administration
11184851|NCT02091362|EG001|Reported Event|Placebo|AEs from Period 1 and 2 combined from placebo administration.
11184852|NCT02091362|EG002|Reported Event|Wash-out|All AEs included during wash-out period.
11184853|NCT02091362|EG003|Reported Event|Follow-up|All AEs from follow-up period.
11184854|NCT02091375|BG000|Baseline|GWP42003-P 20 mg/kg/Day Dose|Participants received 20 mg/kg/day of GWP42003-P administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period. Participants received at least 1 dose of IMP; analyzed according to the actual treatment received (GWP42003-P).
11184855|NCT02091375|BG001|Baseline|Placebo|Participants received placebo (0 mg/mL CBD), volume-matched to the 20 mg/kg/day dose level, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period. Participants received at least 1 dose of IMP; analyzed according to the actual treatment received (placebo).
11184856|NCT02091375|BG002|Baseline|Total|Total of all reporting groups
11184857|NCT02091375|FG000|Participant Flow|GWP42003-P 20 mg/kg/Day Dose|Participants received 20 milligrams (mg) per kilogram (kg) per day of GWP42003-P administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the open-label extension (OLE) study, the maintenance period was followed by a 10-day taper (10% per day) period.
11236355|NCT02448719|OG012|Outcome|Cohort 4b-1: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11357711|NCT03748979|OG001|Outcome|Part A, Cohort A1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11236356|NCT02448719|OG013|Outcome|Cohort 5b-1: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236357|NCT02448719|OG014|Outcome|Cohort 6b: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
10961811|NCT00863057|OG001|Outcome|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
10961812|NCT00863057|OG002|Outcome|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
11236358|NCT02448719|OG015|Outcome|Cohort 4b-2: Placebo|TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236359|NCT02448719|OG016|Outcome|Cohort 4b-2: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236360|NCT02448719|OG017|Outcome|Cohort 5b-2: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236361|NCT02448719|OG018|Outcome|Cohort 5b-2: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236362|NCT02448719|OG000|Outcome|Cohort 1a: TAK-792 30 mg|TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236363|NCT02448719|OG001|Outcome|Cohort 2a: TAK-792 100 mg|TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236364|NCT02448719|OG002|Outcome|Cohort 3a: TAK-792 250 mg|TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236365|NCT02448719|OG003|Outcome|Cohort 4a-1: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
11236366|NCT02448719|OG004|Outcome|Cohort 5a-1: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
11236367|NCT02448719|OG005|Outcome|Cohort 6a: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236368|NCT02448719|OG006|Outcome|Cohort 4a-2: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236369|NCT02448719|OG007|Outcome|Cohort 5a-2: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
11236370|NCT02448719|OG008|Outcome|Cohort 4b-1: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236371|NCT02448719|OG009|Outcome|Cohort 5b-1: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236372|NCT02448719|OG010|Outcome|Cohort 6b: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236373|NCT02448719|OG011|Outcome|Cohort 4b-2: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236374|NCT02448719|OG012|Outcome|Cohort 5b-2: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236375|NCT02448719|OG000|Outcome|Cohort 4a-2: Placebo|TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236376|NCT02448719|OG001|Outcome|Cohort 4a-2: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236377|NCT02448719|OG002|Outcome|Cohort 4b-2: Placebo|TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236378|NCT02448719|OG003|Outcome|Cohort 4b-2: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236379|NCT02448719|OG004|Outcome|Cohort 5a-2: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
11236380|NCT02448719|OG005|Outcome|Cohort 5a-2: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
11236381|NCT02448719|OG006|Outcome|Cohort 5b-2: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236382|NCT02448719|OG007|Outcome|Cohort 5b-2: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236383|NCT02448719|EG000|Reported Event|Cohort 1a-6a: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236384|NCT02448719|EG001|Reported Event|Cohort 1a: TAK-792 30 mg|TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236385|NCT02448719|EG002|Reported Event|Cohort 2a: TAK-792 100 mg|TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236386|NCT02448719|EG003|Reported Event|Cohort 3a: TAK-792 250 mg|TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236387|NCT02448719|EG004|Reported Event|Cohort 4a-1: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
11236388|NCT02448719|EG005|Reported Event|Cohort 5a-1: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
11236389|NCT02448719|EG006|Reported Event|Cohort 6a: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236390|NCT02448719|EG007|Reported Event|Cohort 4a-2: Placebo|TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236391|NCT02448719|EG008|Reported Event|Cohort 4a-2: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
11236392|NCT02448719|EG009|Reported Event|Cohort 5a-2: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
11236393|NCT02448719|EG010|Reported Event|Cohort 5a-2: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
11236394|NCT02448719|EG011|Reported Event|Cohort 4b-1 - 6b: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236395|NCT02448719|EG012|Reported Event|Cohort 4b-1: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236396|NCT02448719|EG013|Reported Event|Cohort 5b-1: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236397|NCT02448719|EG014|Reported Event|Cohort 6b: TAK-792 1250 mg|TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236398|NCT02448719|EG015|Reported Event|Cohort 4b-2: Placebo|TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236399|NCT02448719|EG016|Reported Event|Cohort 4b-2: TAK-792 500 mg|TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236400|NCT02448719|EG017|Reported Event|Cohort 5b-2: Placebo|TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236401|NCT02448719|EG018|Reported Event|Cohort 5b-2: TAK-792 750 mg|TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
11236402|NCT02448771|BG000|Baseline|Palbociclib in Combination With Bazedoxifene|"Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle~One cycle is 28 days."
11236403|NCT02448771|FG000|Participant Flow|Palbociclib in Combination With Bazedoxifene|"Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle~One cycle is 28 days."
11236404|NCT02448771|OG000|Outcome|Palbociclib in Combination With Bazedoxifene|"Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle~One cycle is 28 days."
11236405|NCT02448771|OG000|Outcome|Palbociclib in Combination With Bazedoxifene|"Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle~One cycle is 28 days.~Palbociclib~Bazedoxifene"
11236406|NCT02448771|EG000|Reported Event|Palbociclib in Combination With Bazedoxifene|"Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle~One cycle is 28 days."
11236407|NCT02448810|BG000|Baseline|Part 1: Imalumab 7.5 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236408|NCT02448810|BG001|Baseline|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236409|NCT02448810|BG002|Baseline|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236410|NCT02448810|BG003|Baseline|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236411|NCT02448810|BG004|Baseline|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236412|NCT02448810|BG005|Baseline|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236413|NCT02448810|BG006|Baseline|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236414|NCT02448810|BG007|Baseline|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236415|NCT02448810|BG008|Baseline|Total|Total of all reporting groups
11236416|NCT02448810|FG000|Participant Flow|Part 1: Imalumab 7.5 mg/kg + 5-FU/LV|Participants with mutated tumors (mutated kirsten rat sarcoma viral oncogene homolog, mutated neuroblastoma rat sarcoma viral oncogene homolog [KRAS mut, NRAS mut]) received 7.5 milligram per kilogram (mg/kg) dose of imalumab every week (QW) in combination with 5-fluorouracil/leucovorin ([FU/LV] LV 400 milligram per square meter [mg/m^2] intravenous (IV) infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for every 2 weeks (Q2W) IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236417|NCT02448810|FG001|Participant Flow|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (wild type Kirsten rat sarcoma viral oncogene homolog, wild neuroblastoma rat sarcoma viral oncogene homolog [KRAS wt, NRAS wt]) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236418|NCT02448810|FG002|Participant Flow|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236419|NCT02448810|FG003|Participant Flow|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236420|NCT02448810|FG004|Participant Flow|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236421|NCT02448810|FG005|Participant Flow|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236422|NCT02448810|FG006|Participant Flow|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236423|NCT02448810|FG007|Participant Flow|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236424|NCT02448810|OG000|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236425|NCT02448810|OG001|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236426|NCT02448810|OG002|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236427|NCT02448810|OG003|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236428|NCT02448810|OG000|Outcome|Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV)|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236429|NCT02448810|OG001|Outcome|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236430|NCT02448810|OG002|Outcome|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236431|NCT02448810|OG003|Outcome|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236432|NCT02448810|OG004|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236433|NCT02448810|OG005|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236434|NCT02448810|OG006|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236435|NCT02448810|OG007|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236436|NCT02448810|EG000|Reported Event|Part 1: Imalumab 7.5 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236437|NCT02448810|EG001|Reported Event|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236438|NCT02448810|EG002|Reported Event|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236439|NCT02448810|EG003|Reported Event|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236440|NCT02448810|EG004|Reported Event|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236441|NCT02448810|EG005|Reported Event|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236442|NCT02448810|EG006|Reported Event|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236443|NCT02448810|EG007|Reported Event|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
11236444|NCT02448862|BG000|Baseline|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
11184858|NCT02091375|FG001|Participant Flow|Placebo|Participants received placebo (0 mg/mL cannabidiol [CBD]), volume-matched to the 20 mg/kg/day dose level, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
11184859|NCT02091375|OG000|Outcome|GWP42003-P 20 mg/kg/Day Dose|Participants received 20 mg/kg/day of GWP42003-P administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
11184860|NCT02091375|OG001|Outcome|Placebo|Participants received placebo (0 mg/mL CBD), volume-matched to the 20 mg/kg/day dose level, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
11184861|NCT02091375|EG000|Reported Event|GWP42003-P 20 mg/kg/Day Dose|Participants received 20 mg/kg/day of GWP42003-P administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
11184862|NCT02091375|EG001|Reported Event|Placebo|Participants received placebo (0 mg/mL CBD), volume-matched to the 20 mg/kg/day dose level, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
11184863|NCT02091414|BG000|Baseline|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
11184864|NCT02091414|FG000|Participant Flow|Mycophenolate Mofetil (MMF) Plus (+) Cyclosporine A (CsA)|Participants received MMF 1.0 grams (g), capsules orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 milligrams per kilogram (mg/kg) PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
11184865|NCT02091414|OG000|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
11184866|NCT02091414|EG000|Reported Event|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
11184867|NCT02091440|BG000|Baseline|HW005 Ventricular Assist System|Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
11184868|NCT02091440|FG000|Participant Flow|HW005 Ventricular Assist System|Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
11184869|NCT02091440|OG000|Outcome|HW005 Ventricular Assist System|Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
11184870|NCT02091440|EG000|Reported Event|HW005 Ventricular Assist System|Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
11184871|NCT02091466|BG000|Baseline|Pre-warming|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
11184872|NCT02091466|BG001|Baseline|Control|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
11184873|NCT02091466|BG002|Baseline|Total|Total of all reporting groups
11184874|NCT02091466|FG000|Participant Flow|Pre-warming|"patients were under heating system in experimental groups~heating system pre-warming: warming 30 minutes prior to anesthesia"
11184875|NCT02091466|FG001|Participant Flow|Control|patients were under passive heating in control groups before anesthesia
11184876|NCT02091466|OG000|Outcome|Pre-warming|Patients were covered with a thermal gown (Bair Paws Standard Warming Gown 810 model with a Bair Hugger, model 850 warming unit) with forced-air flow at 40ºC in the preoperative care unit 30 minutes before the spinal anesthesia.
11184877|NCT02091466|OG001|Outcome|Control|Patients remained without the use of a thermal gown,
11184878|NCT02091466|EG000|Reported Event|Pre-warming|"Patients were under heating system in experimental groups~heating system pre-warming: warming 30 minutes prior to anesthesia"
11184879|NCT02091466|EG001|Reported Event|Control|Patients were under passive heating in control groups before anesthesia
11184880|NCT02091531|BG000|Baseline|MLN0128|"Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone.~MLN0128"
11184881|NCT02091531|FG000|Participant Flow|MLN0128|"Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone.~MLN0128"
11184882|NCT02091531|OG000|Outcome|MLN0128|"Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone.~MLN0128"
11184883|NCT02091531|EG000|Reported Event|MLN0128|"Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone.~MLN0128"
11184884|NCT02091726|BG000|Baseline|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
11184885|NCT02091726|FG000|Participant Flow|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
11184886|NCT02091726|OG000|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
11184887|NCT02091726|EG000|Reported Event|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
11184888|NCT02091739|BG000|Baseline|MP: Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184889|NCT02091739|BG001|Baseline|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184890|NCT02091739|BG002|Baseline|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184891|NCT02091739|BG003|Baseline|Total|Total of all reporting groups
11184892|NCT02091739|FG000|Participant Flow|Placebo|Participants received one injection session of overall 2.0 milliliter (mL) placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184893|NCT02091739|FG001|Participant Flow|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184894|NCT02091739|FG002|Participant Flow|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184895|NCT02091739|FG003|Participant Flow|EP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
11184896|NCT02091739|FG004|Participant Flow|EP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
11184897|NCT02091739|OG000|Outcome|MP: Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184898|NCT02091739|OG001|Outcome|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184899|NCT02091739|OG002|Outcome|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184900|NCT02091739|EG000|Reported Event|Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184901|NCT02091739|EG001|Reported Event|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184902|NCT02091739|EG002|Reported Event|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
11184903|NCT02091739|EG003|Reported Event|EP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
11184904|NCT02091739|EG004|Reported Event|EP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
11184905|NCT02091778|BG000|Baseline|Fast Gelling Dressing|Fast gelling dressing
11184906|NCT02091778|FG000|Participant Flow|Fast Gelling Dressing|Fast gelling dressing
11184907|NCT02091778|OG000|Outcome|Fast Gelling Dressing|Fast gelling dressing
11184908|NCT02091778|EG000|Reported Event|Fast Gelling Dressing|Fast gelling dressing
11184909|NCT02091856|BG000|Baseline|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
11184910|NCT02091856|BG001|Baseline|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
11184911|NCT02091856|BG002|Baseline|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
11184912|NCT02091856|BG003|Baseline|Total|Total of all reporting groups
11184913|NCT02091856|FG000|Participant Flow|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
11184914|NCT02091856|FG001|Participant Flow|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
11184915|NCT02091856|FG002|Participant Flow|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
11184916|NCT02091856|OG000|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
11184917|NCT02091856|OG001|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
11184918|NCT02091856|OG002|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
11184919|NCT02091856|EG000|Reported Event|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
11184920|NCT02091856|EG001|Reported Event|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
11184921|NCT02091856|EG002|Reported Event|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
11184922|NCT02091869|BG000|Baseline|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
11184923|NCT02091869|BG001|Baseline|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
11184924|NCT02091869|BG002|Baseline|Total|Total of all reporting groups
11184925|NCT02091869|FG000|Participant Flow|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
11184926|NCT02091869|FG001|Participant Flow|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
11184927|NCT02091869|OG000|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
11184928|NCT02091869|OG001|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
11184929|NCT02091869|EG000|Reported Event|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
11184930|NCT02091869|EG001|Reported Event|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
11184931|NCT02091882|BG000|Baseline|Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System|"Participants were placed a patch by the clinical staff prior to each IEM tablet ingestion. Participants received one IEM tablet approximately every 2 hours, for a total of 4 ingestions on Day 1 at 0, 2, 4 and 6 hours.~Following placement of the patch by clinic staff, participants ingested one 10 mg aripiprazole-embedded IEM tablet without food at Hour 0, one placebo-embedded IEM tablet without food at approximately Hour 2, one placebo-embedded IEM tablet with a high fat meal at approximately Hour 4, and one placebo-embedded IEM tablet without food at approximately Hour 6. Clinic staff recorded the time of each ingestion of an IEM and the time it was detected by MIND1 System."
11184932|NCT02091882|FG000|Participant Flow|Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System|"Participants were placed a patch by the clinical staff prior to each ingestible event marker (IEM) tablet ingestion. Participants received one IEM tablet approximately every 2 hours, for a total of 4 ingestions on Day 1 at 0, 2, 4 and 6 hours.~Following placement of the patch by clinic staff, participants ingested one 10 mg aripiprazole-embedded IEM tablet without food at Hour 0, one placebo-embedded IEM tablet without food at approximately Hour 2, one placebo-embedded IEM tablet with a high fat meal at approximately Hour 4, and one placebo-embedded IEM tablet without food at approximately Hour 6. Clinic staff recorded the time of each ingestion of an IEM and the time it was detected by MIND1 System."
11184933|NCT02091882|OG000|Outcome|Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System|"Participants were placed a patch by the clinical staff prior to each ingestible event marker (IEM) tablet ingestion. Participants received one IEM tablet approximately every 2 hours, for a total of 4 ingestions on Day 1 at 0, 2, 4 and 6 hours.~Following placement of the patch by clinic staff, participants ingested one 10 mg aripiprazole-embedded IEM tablet without food at Hour 0, one placebo-embedded IEM tablet without food at approximately Hour 2, one placebo-embedded IEM tablet with a high fat meal at approximately Hour 4, and one placebo-embedded IEM tablet without food at approximately Hour 6. Clinic staff recorded the time of each ingestion of an IEM and the time it was detected by MIND1 System."
11184934|NCT02091882|EG000|Reported Event|Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System|"Participants were placed a patch by the clinical staff prior to each ingestible event marker (IEM) tablet ingestion. Participants received one IEM tablet approximately every 2 hours, for a total of 4 ingestions on Day 1 at 0, 2, 4 and 6 hours.~Following placement of the patch by clinic staff, participants ingested one 10 mg aripiprazole-embedded IEM tablet without food at Hour 0, one placebo-embedded IEM tablet without food at approximately Hour 2, one placebo-embedded IEM tablet with a high fat meal at approximately Hour 4, and one placebo-embedded IEM tablet without food at approximately Hour 6. Clinic staff recorded the time of each ingestion of an IEM and the time it was detected by MIND1 System."
11184935|NCT02091921|BG000|Baseline|Experimental|"All subjects will receive Ticagrelor.~Ticagrelor: All patients will be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose."
11184936|NCT02091921|FG000|Participant Flow|Experimental|"All subjects will receive Ticagrelor.~Ticagrelor: All patients will be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose."
11184937|NCT02091921|OG000|Outcome|Ticagrelor|All patients were switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks
11184938|NCT02091921|OG000|Outcome|HPR on Clopidogrel and API on Ticagrelor|Participants who demonstrated HPR on clopidogrel
11184939|NCT02091921|OG000|Outcome|API on Clopidogrel and API on Ticagrelor|Participants with Appropriate Platelet Inhibition (API) on Clopidogrel.
11184940|NCT02091921|OG000|Outcome|Correlation of PRU and VASP-PRI|Participants who were switched from clopidogrel to ticagrelor
11184941|NCT02091921|EG000|Reported Event|Experimental|All participants will switch from clopidogrel to ticagrelor for two weeks
11184942|NCT02091986|BG000|Baseline|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
11184943|NCT02091986|BG001|Baseline|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
11184944|NCT02091986|BG002|Baseline|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
11184945|NCT02091986|BG003|Baseline|Total|Total of all reporting groups
11184946|NCT02091986|FG000|Participant Flow|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
11184947|NCT02091986|FG001|Participant Flow|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
11184948|NCT02091986|FG002|Participant Flow|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
11184949|NCT02091986|OG000|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
11184950|NCT02091986|OG001|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
11184951|NCT02091986|OG002|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
11184952|NCT02091986|EG000|Reported Event|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
11184953|NCT02091986|EG001|Reported Event|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
11184954|NCT02091986|EG002|Reported Event|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
11184955|NCT02092025|BG000|Baseline|Azilsartan|Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11184956|NCT02092025|FG000|Participant Flow|Azilsartan|Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11184957|NCT02092025|OG000|Outcome|Azilsartan|Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11184958|NCT02092025|EG000|Reported Event|Azilsartan|Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11184959|NCT02092116|BG000|Baseline|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
11184960|NCT02092116|BG001|Baseline|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
11184961|NCT02092116|BG002|Baseline|Total|Total of all reporting groups
11184962|NCT02092116|FG000|Participant Flow|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
11184963|NCT02092116|FG001|Participant Flow|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
11184964|NCT02092116|OG000|Outcome|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
11184965|NCT02092116|OG000|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
11184966|NCT02092116|EG000|Reported Event|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
11341447|NCT03682302|BG001|Baseline|Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine|Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
11357712|NCT03748979|OG002|Outcome|Part A, Cohort A2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11236445|NCT02448862|BG001|Baseline|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
11236446|NCT02448862|BG002|Baseline|Total|Total of all reporting groups
11236447|NCT02448862|FG000|Participant Flow|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
11236448|NCT02448862|FG001|Participant Flow|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
11236449|NCT02448862|OG000|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
11236450|NCT02448862|OG001|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
11236451|NCT02448862|EG000|Reported Event|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
11236452|NCT02448862|EG001|Reported Event|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
11236453|NCT02448875|BG000|Baseline|CyPass|CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye
11236454|NCT02448875|BG001|Baseline|CyPass30|CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
11236455|NCT02448875|BG002|Baseline|CyPass60|CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
11236456|NCT02448875|BG003|Baseline|Total|Total of all reporting groups
11236457|NCT02448875|FG000|Participant Flow|CyPass|CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye
11236458|NCT02448875|FG001|Participant Flow|CyPass30|CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
11236459|NCT02448875|FG002|Participant Flow|CyPass60|CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
11236460|NCT02448875|OG000|Outcome|CyPass|CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye
11236461|NCT02448875|OG001|Outcome|CyPass30|CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
11236462|NCT02448875|OG002|Outcome|CyPass60|CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
11236463|NCT02448875|EG000|Reported Event|CyPass Ocular|Subjects with CyPass Micro-Stent implantation
11236464|NCT02448875|EG001|Reported Event|CyPass Nonocular|Subjects with CyPass Micro-Stent implantation
11236465|NCT02448875|EG002|Reported Event|CyPass30 Ocular|Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
11184967|NCT02092116|EG001|Reported Event|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of romidepsin infusion (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
11184968|NCT02092168|BG000|Baseline|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
11184969|NCT02092168|BG001|Baseline|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
11184970|NCT02092168|BG002|Baseline|Total|Total of all reporting groups
11184971|NCT02092168|FG000|Participant Flow|BIA 9-1067 30 mg (QD) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (QD) - Elderly Subjects"
11184972|NCT02092168|FG001|Participant Flow|BIA 9-1067 30 mg (QD) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (QD) - Young Subjects"
11184973|NCT02092168|OG000|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
11184974|NCT02092168|OG001|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
11184975|NCT02092168|EG000|Reported Event|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
11184976|NCT02092168|EG001|Reported Event|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
11184977|NCT02092181|BG000|Baseline|Mirabegron|"1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.~Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.~Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose."
11184978|NCT02092181|BG001|Baseline|Placebo|"1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.~Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.~Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose."
11184979|NCT02092181|BG002|Baseline|Total|Total of all reporting groups
11184980|NCT02092181|FG000|Participant Flow|Mirabegron|"1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.~Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.~Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose."
11184981|NCT02092181|FG001|Participant Flow|Placebo|"1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.~Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.~Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose."
11184982|NCT02092181|OG000|Outcome|Mirabegron|"1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.~Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.~Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose."
11184983|NCT02092181|OG001|Outcome|Placebo|"1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.~Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.~Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose."
11184984|NCT02092181|EG000|Reported Event|Mirabegron|"1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.~Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.~Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose."
11236466|NCT02448875|EG003|Reported Event|CyPass30 Nonocular|Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
11236467|NCT02448875|EG004|Reported Event|CyPass60 Ocular|Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
11236468|NCT02448875|EG005|Reported Event|CyPass60 Nonocular|Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
11236469|NCT02448914|BG000|Baseline|TRIGEL and Duodopa in Randomized Order|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
11236470|NCT02448914|FG000|Participant Flow|TRIGEL First, Then Duodopa|"First Intervention (Day 1): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~Second Intervention (Day 2): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
11236471|NCT02448914|FG001|Participant Flow|Duodopa First, Then TRIGEL|"First Intervention (Day 1): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~Second Intervention (Day 2): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
11236472|NCT02448914|OG000|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
11236473|NCT02448914|OG001|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
11236474|NCT02448914|OG000|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
11236475|NCT02448914|EG000|Reported Event|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
11236476|NCT02448914|EG001|Reported Event|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
11236477|NCT02449018|BG000|Baseline|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
11236478|NCT02449018|BG001|Baseline|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
11236479|NCT02449018|BG002|Baseline|Total|Total of all reporting groups
11236480|NCT02449018|FG000|Participant Flow|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
11236481|NCT02449018|FG001|Participant Flow|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
11236482|NCT02449018|OG000|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
11236483|NCT02449018|OG001|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
11236484|NCT02449018|EG000|Reported Event|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
11236485|NCT02449018|EG001|Reported Event|QBW251 300 mg Bid|QBW251 (28 day treatment period) and placebo (42 days, run-in and wash-out periods)
11236486|NCT02449044|BG000|Baseline|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant's response in serum sodium concentration and clinical tolerance of study drug.
11236487|NCT02449044|FG000|Participant Flow|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant's response in serum sodium concentration and clinical tolerance of study drug.
11236488|NCT02449044|OG000|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant's response in serum sodium concentration and clinical tolerance of study drug.
11236489|NCT02449044|EG000|Reported Event|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant's response in serum sodium concentration and clinical tolerance of study drug.
11240781|NCT02481869|BG000|Baseline|Platelet Rich Plasma|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. A needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected. Using the same needle, the PRP will be delivered into the joint.~Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.~Arthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation"
11240782|NCT02481869|BG001|Baseline|Saline|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.~Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.~Arthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation"
11240783|NCT02481869|BG002|Baseline|Total|Total of all reporting groups
11240784|NCT02481869|FG000|Participant Flow|Platelet Rich Plasma|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.~Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.~Arthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s"
11240785|NCT02481869|FG001|Participant Flow|Saline|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.~Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.~Arthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation"
11240786|NCT02481869|OG000|Outcome|Platelet Rich Plasma|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected. Using the same needle, the PRP will be delivered. Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles. Arthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation"
11341448|NCT03682302|BG002|Baseline|Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
11341449|NCT03682302|BG003|Baseline|Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
11236490|NCT02449174|BG000|Baseline|Frozen Microbiota|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema~Frozen Microbiota: Frozen Microbiota will be delivered via enema route."
11236491|NCT02449174|BG001|Baseline|Lyophilized Microbiota|"Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally~Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally."
11236492|NCT02449174|BG002|Baseline|Total|Total of all reporting groups
11236493|NCT02449174|FG000|Participant Flow|Frozen Microbiota|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema~Frozen Microbiota: Frozen Microbiota will be delivered via enema route."
11236494|NCT02449174|FG001|Participant Flow|Lyophilized Microbiota|"Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally~Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally."
11236495|NCT02449174|OG000|Outcome|Frozen Microbiota|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema~Frozen Microbiota: Frozen Microbiota will be delivered via enema route."
11236496|NCT02449174|OG001|Outcome|Lyophilized Microbiota|"Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally~Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally."
11236497|NCT02449174|EG000|Reported Event|Frozen Microbiota|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema~Frozen Microbiota: Frozen Microbiota will be delivered via enema route."
11236498|NCT02449174|EG001|Reported Event|Lyophilized Microbiota|"Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally~Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally."
11236499|NCT02449291|BG000|Baseline|APD421 5mg|APD421 5mg dose administered as a single, slow, intravenous (IV) push over about two minutes
11236500|NCT02449291|BG001|Baseline|APD421 10mg|APD421 10mg dose administered as a single, slow, intravenous (IV) push over about two minutes
11236501|NCT02449291|BG002|Baseline|Placebo|Matching placebo administered as a single, slow, IV push over about two minutes
11236502|NCT02449291|BG003|Baseline|Total|Total of all reporting groups
11236503|NCT02449291|FG000|Participant Flow|APD421 Standard|Single (standard) dose IV APD421
11236504|NCT02449291|FG001|Participant Flow|APD421 High|Single (high) dose IV APD421
11236505|NCT02449291|FG002|Participant Flow|Placebo|Single IV placebo
11236506|NCT02449291|OG000|Outcome|APD421 5mg IV|APD421 (amisulpride) at 5mg administered as a single, slow, intravenous (IV) push over about two minutes.
11236507|NCT02449291|OG001|Outcome|APD421 10mg IV|APD421 (amisulpride) at 10 mg administered as a single, slow, intravenous (IV) push over about two minutes.
11236508|NCT02449291|OG002|Outcome|Placebo|Single IV placebo administered as a single, slow, intravenous (IV) push over about two minutes.
11236509|NCT02449291|OG000|Outcome|APD421 5mg|APD421 5mg dose administered as a single, slow, intravenous (IV) push over about two minutes
11236510|NCT02449291|OG001|Outcome|APD421 10mg|APD421 10mg dose administered as a single, slow, intravenous (IV) push over about two minutes
11236511|NCT02449291|OG002|Outcome|Placebo|Matching placebo administered as a single, slow, IV push over about two minutes
11236512|NCT02449291|EG000|Reported Event|APD421 5 mg|Single 5 mg dose IV APD421
11236513|NCT02449291|EG001|Reported Event|APD421 10 mg|Single 10 mg dose IV APD421
11184985|NCT02092181|EG001|Reported Event|Placebo|"1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.~Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.~Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose."
11184986|NCT02092220|BG000|Baseline|All Randomized Participants|All randomized participants who completed both periods of the study.
11184987|NCT02092220|FG000|Participant Flow|Bionic Pancreas Then Usual Care|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 1 followed by Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 2. There was a 3 to 10-day washout period between periods.
11184988|NCT02092220|FG001|Participant Flow|Usual Care Then Bionic Pancreas|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 1 followed by Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 2. There was a 3 to 10-day washout period between periods.
11184989|NCT02092220|OG000|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
11184990|NCT02092220|OG001|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
11184991|NCT02092220|OG000|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
11184992|NCT02092220|OG000|Outcome|Bionic Pancreas|All randomized participants who completed both periods of the study.
11184993|NCT02092220|EG000|Reported Event|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
11184994|NCT02092220|EG001|Reported Event|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
11184995|NCT02092285|BG000|Baseline|Golimumab|The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
11184996|NCT02092285|FG000|Participant Flow|Golimumab|The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
11184997|NCT02092285|OG000|Outcome|Golimumab|The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
11184998|NCT02092285|EG000|Reported Event|Golimumab|The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
11184999|NCT02092298|BG000|Baseline|Hyperthermic Intraperitoneal Chemotherapy (HIPEC)|"Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.~Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes.~Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.~Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours."
11185000|NCT02092298|FG000|Participant Flow|Hyperthermic Intraperitoneal Chemotherapy (HIPEC)|"Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.~Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes.~Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.~Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours."
11236514|NCT02449291|EG002|Reported Event|Placebo|Single IV placebo
11341450|NCT03682302|BG004|Baseline|Total|Total of all reporting groups
11236515|NCT02449356|BG000|Baseline|Prone Position Endotracheal Tube(PPT)|We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the prone position endotracheal tube group(PPT), in which group the patients were intubated with the custom-designed endotracheal tube.
11236516|NCT02449356|BG001|Baseline|Traditional Endotracheal Tube(TT)|We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the traditional endotracheal tube group(TT), in which group the patients were intubated with the routine endotracheal tube.
11236517|NCT02449356|BG002|Baseline|Total|Total of all reporting groups
11236518|NCT02449356|FG000|Participant Flow|Traditional Endotracheal Tube(TT)|the subjects of this arm are given the routine endotracheal tube.
11236519|NCT02449356|FG001|Participant Flow|Prone Position Endotracheal Tube(PPT)|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
11236520|NCT02449356|OG000|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
11236521|NCT02449356|OG001|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
11236522|NCT02449356|OG000|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
11236523|NCT02449356|OG001|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
11236524|NCT02449356|EG000|Reported Event|Prone Position Endotracheal Tube|there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
11236525|NCT02449356|EG001|Reported Event|Traditional Endotracheal Tube|there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
11236526|NCT02449434|BG000|Baseline|Severe Erosive Tooth Wear|BEWE score of 12 or higher and at least one score of 3 in a sextant whereas
11236527|NCT02449434|BG001|Baseline|Mild/Moderate Erosive Tooth Wear|BEWE score of 10 or lower and no score of 3 on any surface of any tooth
11236528|NCT02449434|BG002|Baseline|Total|Total of all reporting groups
11236529|NCT02449434|FG000|Participant Flow|Severe Erosive Tooth Wear|a BEWE score of 12 or higher and at least one score of 3 in a sextant
11236530|NCT02449434|FG001|Participant Flow|Mild/Moderate Erosive Tooth Wear|A BEWE score of 10 or lower and no score of 3 on any surface of any tooth
11236531|NCT02449434|OG000|Outcome|Severe Erosive Tooth Wear|Erosive tooth wear cases were defined as those with a BEWE score of 12 or higher and at least one score of 3 in a sextant
11236532|NCT02449434|OG001|Outcome|Mild/Moderate Erosive Tooth Wear|Controls were defined as those with a BEWE score of 10 or lower and no score of 3 on any surface of any tooth (clinically classified as no or mild erosive tooth wear)
11236533|NCT02449434|EG000|Reported Event|Severe Erosive Tooth Wear|"BEWE score of 12 or higher and at least one score of 3 in a sextant~Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed"
11236534|NCT02449434|EG001|Reported Event|Mild/Moderate Erosive Tooth Wear|"BEWE score of 10 or lower and no score of 3 on any surface of any tooth~Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed"
11236535|NCT02449473|BG000|Baseline|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
11236536|NCT02449473|BG001|Baseline|Placebo|Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
11236537|NCT02449473|BG002|Baseline|Total|Total of all reporting groups
11236538|NCT02449473|FG000|Participant Flow|Tralo 300 mg Q2W|Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 12-week treatment period (up to 6 doses).
11236539|NCT02449473|FG001|Participant Flow|Placebo|Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
11236540|NCT02449473|OG000|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
11236541|NCT02449473|OG001|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
11236542|NCT02449473|EG000|Reported Event|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
11236543|NCT02449473|EG001|Reported Event|Placebo|Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
11236544|NCT02449798|BG000|Baseline|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
11236545|NCT02449798|FG000|Participant Flow|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 Blood Control (BC) peripheral intravenous (PIV) device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
11357713|NCT03748979|OG003|Outcome|Part A, Cohort A3: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357714|NCT03748979|OG004|Outcome|Part B, Cohorts B1-B2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357715|NCT03748979|OG005|Outcome|Part B, Cohort B1: TAK-925 11 mg|TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357716|NCT03748979|OG006|Outcome|Part B, Cohort B2: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357717|NCT03748979|OG007|Outcome|Part C, Cohorts C1-C2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357718|NCT03748979|OG008|Outcome|Part C, Cohort C1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357719|NCT03748979|OG009|Outcome|Part C, Cohort C2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357720|NCT03748979|OG010|Outcome|Part A', Cohort A'1: TAK-925 112 mg|TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
11357721|NCT03748979|OG000|Outcome|Part A, Cohort A1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357722|NCT03748979|OG001|Outcome|Part A, Cohort A2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357723|NCT03748979|OG002|Outcome|Part A, Cohort A3: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357724|NCT03748979|OG003|Outcome|Part B, Cohort B1: TAK-925 11 mg|TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357725|NCT03748979|OG004|Outcome|Part B, Cohort B2: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357726|NCT03748979|OG005|Outcome|Part C, Cohort C1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357727|NCT03748979|OG006|Outcome|Part C, Cohort C2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357728|NCT03748979|OG000|Outcome|Part B, Cohorts B1-B2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357729|NCT03748979|OG001|Outcome|Part B, Cohort B1: TAK-925 11 mg|TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357730|NCT03748979|OG002|Outcome|Part B, Cohort B2: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357731|NCT03748979|OG003|Outcome|Part C, Cohorts C1-C2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357732|NCT03748979|OG004|Outcome|Part C, Cohort C1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357733|NCT03748979|OG005|Outcome|Part C, Cohort C2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357734|NCT03748979|EG000|Reported Event|Part A, Cohorts A1-A3: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357735|NCT03748979|EG001|Reported Event|Part A, Cohort A1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357736|NCT03748979|EG002|Reported Event|Part A, Cohort A2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357737|NCT03748979|EG003|Reported Event|Part A, Cohort A3: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
11357738|NCT03748979|EG004|Reported Event|Part B, Cohorts B1-B2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357739|NCT03748979|EG005|Reported Event|Part B, Cohort B1: TAK-925 11 mg|TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357740|NCT03748979|EG006|Reported Event|Part B, Cohort B2: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.
11357741|NCT03748979|EG007|Reported Event|Part C, Cohorts C1-C2: Pooled Placebo|TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357742|NCT03748979|EG008|Reported Event|Part C, Cohort C1: TAK-925 44 mg|TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357743|NCT03748979|EG009|Reported Event|Part C, Cohort C2: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.
11357744|NCT03748979|EG010|Reported Event|Part A', Cohort A'1: TAK-925 112 mg|TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
11357745|NCT03748758|BG000|Baseline|Drug: OP0201 Cohort A 30 mg Per Day|"Cohort A- 30 mg per day X 14 days~Drug: OP0201: Drug OP0201"
11357746|NCT03748758|BG001|Baseline|Drug: OP0201 Cohort B 60 mg Per Day|"Cohort B-60 mg per day X 14 days~Drug: OP0201: Drug OP0201"
11357747|NCT03748758|BG002|Baseline|Drug: Placebo|"0 mg per day X 14 days~Drug: Placebo: Placebo"
11357748|NCT03748758|BG003|Baseline|Total|Total of all reporting groups
11357749|NCT03748758|FG000|Participant Flow|Drug: OP0201 Cohort A 30 mg Per Day|"Cohort A- 30 mg per day X 14 days~Drug: OP0201: Drug OP0201"
11357750|NCT03748758|FG001|Participant Flow|Drug: OP0201 Cohort B 60 mg Per Day|"Cohort B-60 mg per day X 14 days~Drug: OP0201: Drug OP0201"
11357751|NCT03748758|FG002|Participant Flow|Drug: Placebo|"0 mg per day X 14 days~Drug: Placebo: Placebo"
11357752|NCT03748758|OG000|Outcome|Drug: OP0201 Cohort A 30 mg Per Day|"Cohort A- 30 mg per day X 14 days~Drug: OP0201: Drug OP0201"
11357753|NCT03748758|OG001|Outcome|Drug: OP0201 Cohort B 60 mg Per Day|"Cohort B-60 mg per day X 14 days~Drug: OP0201: Drug OP0201"
11357754|NCT03748758|OG002|Outcome|Drug: Placebo|"0 mg per day X 14 days~Drug: Placebo: Placebo"
11357755|NCT03748758|OG000|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 1 Baseline|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11357756|NCT03748758|OG001|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11357757|NCT03748758|OG002|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11236546|NCT02449798|OG000|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
11236547|NCT02449798|EG000|Reported Event|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
11236548|NCT02449889|BG000|Baseline|HP-hCG IM|"Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)~Highly purified human chorionic gonadotropin"
11236549|NCT02449889|BG001|Baseline|HP-hCG SC|"Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)~Highly purified human chorionic gonadotropin"
11236550|NCT02449889|BG002|Baseline|rhCG SC|"Recombinant human chorionic gonadotropin 250 µg SC~Recombinant human chorionic gonadotropin"
11236551|NCT02449889|BG003|Baseline|Total|Total of all reporting groups
11236552|NCT02449889|FG000|Participant Flow|HP-hCG IM|"Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)~Highly purified human chorionic gonadotropin"
11236553|NCT02449889|FG001|Participant Flow|HP-hCG SC|"Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)~Highly purified human chorionic gonadotropin"
11236554|NCT02449889|FG002|Participant Flow|rhCG SC|"Recombinant human chorionic gonadotropin 250 µg SC~Recombinant human chorionic gonadotropin"
11236555|NCT02449889|OG000|Outcome|HP-hCG IM|"Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)~Highly purified human chorionic gonadotropin"
11236556|NCT02449889|OG001|Outcome|HP-hCG SC|"Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)~Highly purified human chorionic gonadotropin"
11236557|NCT02449889|OG002|Outcome|rhCG SC|"Recombinant human chorionic gonadotropin 250 µg SC~Recombinant human chorionic gonadotropin"
11236558|NCT02449889|EG000|Reported Event|HP-hCG IM|"Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)~Highly purified human chorionic gonadotropin"
11236559|NCT02449889|EG001|Reported Event|HP-hCG SC|"Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)~Highly purified human chorionic gonadotropin"
11236560|NCT02449889|EG002|Reported Event|rhCG|"Recombinant human chorionic gonadotropin 250 µg SC~Recombinant human chorionic gonadotropin"
11236561|NCT02449902|BG000|Baseline|Estradiol 10 μg Daily for 14 Days|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
11236562|NCT02449902|BG001|Baseline|Placebo Daily for 14 Days|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
11236563|NCT02449902|BG002|Baseline|Total|Total of all reporting groups
11236564|NCT02449902|FG000|Participant Flow|TX-12-004-HR 10μg|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
11236565|NCT02449902|FG001|Participant Flow|Placebo|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
11236566|NCT02449902|OG000|Outcome|TX-12-004-HR 10μg|Active treatment group.
11236567|NCT02449902|OG001|Outcome|Placebo|Control treatment group.
11236568|NCT02449902|OG000|Outcome|Treatment 1|"Estradiol 10 μg vaginal softgel capsule~Estradiol: 1 10 µg capsule inserted vaginally for 14 days."
11236569|NCT02449902|OG001|Outcome|Treatment 2|"Placebo vaginal softgel capsule~placebo: 1 placebo capsule inserted vaginally for 14 days."
11236570|NCT02449902|EG000|Reported Event|TX-12-004-HR|Active treatment group.
11236571|NCT02449902|EG001|Reported Event|Placebo|Control treatment group.
11236572|NCT02449915|BG000|Baseline|Bupivacaine Arm|Receiving 30mL dilutional volume of the liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
11236573|NCT02449915|BG001|Baseline|Placebo Arm|Receiving 30 mL sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
11236574|NCT02449915|BG002|Baseline|Total|Total of all reporting groups
11236575|NCT02449915|FG000|Participant Flow|Bupivacaine Arm|Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
11236576|NCT02449915|FG001|Participant Flow|Placebo Arm|Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
11236577|NCT02449915|OG000|Outcome|Bupivacaine Arm|Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
11236578|NCT02449915|OG001|Outcome|Placebo Arm|Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
11236579|NCT02449915|EG000|Reported Event|Bupivacaine Arm|Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
11236580|NCT02449915|EG001|Reported Event|Placebo Arm|Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
11236581|NCT02450383|BG000|Baseline|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
11236582|NCT02450383|BG001|Baseline|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
11236583|NCT02450383|BG002|Baseline|Total|Total of all reporting groups
11236584|NCT02450383|FG000|Participant Flow|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
11236585|NCT02450383|FG001|Participant Flow|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
11236586|NCT02450383|OG000|Outcome|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
11236587|NCT02450383|OG001|Outcome|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
11236588|NCT02450383|EG000|Reported Event|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
11236589|NCT02450383|EG001|Reported Event|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
11236590|NCT02450487|BG000|Baseline|Interventional Group|"102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control after lower third molar surgery~Piroxicam: After extraction of at least one third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control, collected saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) were analyzed. For the pharmacokinetics of piroxicam saliva samples were collected from 10 of these patients at different times after ingestion of a capsule of 20 mg Piroxicam (before, 1, 2, 3, 4, 5, 6, 8, 11, 24, 48 and 72 hours after ingestion)."
11236591|NCT02450487|FG000|Participant Flow|Interventional Group|"102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control after lower third molar surgery~Piroxicam: After extraction of at least one third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control, collected saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) were analyzed. For the pharmacokinetics of piroxicam saliva samples were collected from 10 of these patients at different times after ingestion of a capsule of 20 mg Piroxicam (before, 1, 2, 3, 4, 5, 6, 8, 11, 24, 48 and 72 hours after ingestion)."
11236592|NCT02450487|OG000|Outcome|Interventional Group|After extraction of one lower third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control
11236593|NCT02450487|OG000|Outcome|Interventional Group|After extraction of one lower third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control.
11236594|NCT02450487|EG000|Reported Event|Interventional Group|After extraction of one lower third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control.
11236595|NCT02450526|BG000|Baseline|Dysport® 50 U - DB Period|"Subjects randomised to the Dysport® treatment group in Cycle 1 received on Day 1, 50 U (0.25 mL), divided into five injections into the glabellar area. 10 U (0.05 mL) of Dysport® was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236596|NCT02450526|BG001|Baseline|Dysport® Placebo - DB Period|"Subjects randomised to the Dysport® placebo group in Cycle 1 received on Day 1, 0.25 mL, divided into five injections into the glabellar area. 0.05 mL of Dysport® placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236597|NCT02450526|BG002|Baseline|Botox 20 U - DB Period|"Subjects randomised to the Botox treatment group in Cycle 1 received on Day 1, 20 U (0.5 mL), divided into five injections into the glabellar area. 4 U (0.1 mL) of Botox was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236598|NCT02450526|BG003|Baseline|Botox Placebo - DB Period|"Subjects randomised to the Botox placebo group in Cycle 1 received on Day 1, 0. 5 mL, divided into five injections into the glabellar area. 0.1 mL of Botox placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236599|NCT02450526|BG004|Baseline|Total|Total of all reporting groups
11341451|NCT03682302|FG000|Participant Flow|Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
11341452|NCT03682302|FG001|Participant Flow|Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine|Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
10961813|NCT00863057|OG003|Outcome|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
10961814|NCT00863057|EG000|Reported Event|Duloxetine and Methadone|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
10961815|NCT00863057|EG001|Reported Event|Duloxetine and Methadone Placebo|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
10961816|NCT00863057|EG002|Reported Event|Duloxetine Placebo and Methadone|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
11185001|NCT02092298|OG000|Outcome|Hyperthermic Intraperitoneal Chemotherapy (HIPEC)|"Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.~Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes.~Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.~Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours."
11185002|NCT02092298|EG000|Reported Event|Hyperthermic Intraperitoneal Chemotherapy (HIPEC)|"Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.~Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes.~Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.~Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours."
11185003|NCT02092311|BG000|Baseline|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
11185004|NCT02092311|BG001|Baseline|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
11185005|NCT02092311|BG002|Baseline|Total|Total of all reporting groups
11185006|NCT02092311|FG000|Participant Flow|Combined Microscopic Varicocelectomy|Combined Mini-Incision Microscopic Varicocelectomy
11185007|NCT02092311|FG001|Participant Flow|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
11185008|NCT02092311|OG000|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
11185009|NCT02092311|OG001|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
11185010|NCT02092311|EG000|Reported Event|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
11185011|NCT02092311|EG001|Reported Event|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
11185012|NCT02092324|BG000|Baseline|Wildtype CSF3R|Subjects with wild type granulocyte Colony Stimulating Factor Receptor 3 (CSF3R)
11185013|NCT02092324|BG001|Baseline|Mutant CSF3R|Subjects with mutant CSF3R
11185014|NCT02092324|BG002|Baseline|Total|Total of all reporting groups
11185015|NCT02092324|FG000|Participant Flow|Treatment (Ruxolitinib Phosphate)|Patients receive ruxolitinib phosphate PO every other day (QOD), or twice a day (BID) on days 1-28. Each patient will be followed for a maximum of 96 weeks (24 cycles, 1 cycle is 4 weeks long). If the study drug continues to be effective, the patient may be eligible to continue on study drug past 24 cycles.
11185016|NCT02092324|OG000|Outcome|First 25 Enrolled Subjects|First 25 enrolled subjects evaluated for protocol-defined objective response
11357758|NCT03748758|OG003|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11236600|NCT02450526|FG000|Participant Flow|Dysport® 50 Units (U) - DB Period|"Subjects randomised to the Dysport® treatment group in Cycle 1 received on Day 1, 50 U (0.25 millilitres [mL]), divided into five injections into the glabellar area. 10 U (0.05 mL) of Dysport® was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236601|NCT02450526|FG001|Participant Flow|Dysport® Placebo - DB Period|"Subjects randomised to the Dysport® placebo group in Cycle 1 received on Day 1, 0.25 mL, divided into five injections into the glabellar area. 0.05 mL of Dysport® placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236602|NCT02450526|FG002|Participant Flow|Botox 20 U - DB Period|"Subjects randomised to the Botox treatment group in Cycle 1 received on Day 1, 20 U (0.5 mL), divided into five injections into the glabellar area. 4 U (0.1 mL) of Botox was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236603|NCT02450526|FG003|Participant Flow|Botox Placebo - DB Period|"Subjects randomised to the Botox placebo group in Cycle 1 received on Day 1, 0. 5 mL, divided into five injections into the glabellar area. 0.1 mL of Botox placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236604|NCT02450526|FG004|Participant Flow|Dysport® 50 U - OL Period (Cycles 2-5)|"After the first treatment cycle, all eligible subjects entered the OL period and received Dysport® 50 U (0.25 mL), injected into five predefined sites across the glabellar region. 10 U (0.05 mL) of Dysport® was administered intramuscularly, at right angles to the skin into each of the five injection sites per treatment cycle.~Subjects received a maximum of four treatment cycles (Cycles 2 to 5) with Dysport®. These cycles occurred at intervals of no less than 84 days (12 weeks) between each cycle, depending upon individual duration of response to Dysport® treatment. Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study."
11236605|NCT02450526|OG000|Outcome|Dysport® 50 U - DB Period|"Subjects randomised to the Dysport® treatment group in Cycle 1 received on Day 1, 50 U (0.25 mL), divided into five injections into the glabellar area. 10 U (0.05 mL) of Dysport® was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236606|NCT02450526|OG001|Outcome|Dysport® Placebo - DB Period|"Subjects randomised to the Dysport® placebo group in Cycle 1 received on Day 1, 0.25 mL, divided into five injections into the glabellar area. 0.05 mL of Dysport® placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11240885|NCT02482675|FG003|Participant Flow|Glucose, Then Whey Protein, Then Milk, Then Sodium Caseinate|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11236607|NCT02450526|OG002|Outcome|Botox 20 U - DB Period|"Subjects randomised to the Botox treatment group in Cycle 1 received on Day 1, 20 U (0.5 mL), divided into five injections into the glabellar area. 4 U (0.1 mL) of Botox was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236608|NCT02450526|OG003|Outcome|Botox Placebo - DB Period|"Subjects randomised to the Botox placebo group in Cycle 1 received on Day 1, 0. 5 mL, divided into five injections into the glabellar area. 0.1 mL of Botox placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236609|NCT02450526|OG000|Outcome|Dysport® 50 U - DB Period|"Subjects randomised to the Dysport® treatment group in Cycle 1 received on Day 1, 50 U (0.25 mL), divided into five injections into the glabellar area. 10 U (0.05 mL) of Dysport® was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection. Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle~1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236610|NCT02450526|OG001|Outcome|Dysport® Placebo - DB Period|Subjects randomised to the Dysport® placebo group in Cycle 1 received on Day 1, 0.25 mL, divided into five injections into the glabellar area. 0.05 mL of Dysport® placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection. Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1.
11236611|NCT02450526|OG001|Outcome|Botox 20 U - DB Period|"Subjects randomised to the Botox treatment group in Cycle 1 received on Day 1, 20 U (0.5 mL), divided into five injections into the glabellar area. 4 U (0.1 mL) of Botox was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236612|NCT02450526|OG000|Outcome|Dysport® 50 U - DB Period|Subjects randomised to the Dysport® treatment group in Cycle 1 received on Day 1, 50 U (0.25 mL), divided into five injections into the glabellar area. 10 U (0.05 mL) of Dysport® was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection. Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1.
11236613|NCT02450526|OG000|Outcome|Dysport® 50 U, Cycle 2 (OL Period)|"All subjects who were eligible for retreatment following the DB period entered Cycle 2 and received OL Dysport® 50 U. The total treatment dose was injected in 5 predefined sites across the glabellar region on Cycle 2, Day 1.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57, and 85 of Cycle 2. Subjects were assessed for the eligibility to receive the next treatment cycle from Day 85.~Any subjects who were not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study when they had either received a total of five study treatment injections or completed a total of 15 months follow-up in the study following the first study treatment administration and completed the Day 85 visit following the last injection."
11337356|NCT03582943|BG000|Baseline|Remote Limb Ischemic Conditioning (RLIC)|"RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC: See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7."
11185017|NCT02092324|OG000|Outcome|Treatment (Ruxolitinib Phosphate)|"Patients receive ruxolitinib phosphate PO every other day, QD, or BID on days 1-28. Each patient will be followed for a maximum of 96 weeks (24 cycles, 1 cycle is 4 weeks long). If the study drug continues to be effective, the patient may be eligible to continue on study drug past 24 cycles.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Ruxolitinib Phosphate: Given PO"
11185018|NCT02092324|OG000|Outcome|Wildtype CSF3R|Subjects with wildtype CSF3R
11185019|NCT02092324|OG001|Outcome|Mutant CSF3R|Subjects with mutant CSF3R
11185020|NCT02092324|EG000|Reported Event|Treatment (Ruxolitinib Phosphate)|"Patients receive ruxolitinib phosphate PO every other day, QD, or BID on days 1-28. Each patient will be followed for a maximum of 96 weeks (24 cycles, 1 cycle is 4 weeks long). If the study drug continues to be effective, the patient may be eligible to continue on study drug past 24 cycles.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Ruxolitinib Phosphate: Given PO"
11185021|NCT02092350|BG000|Baseline|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
11185022|NCT02092350|BG001|Baseline|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
11185023|NCT02092350|BG002|Baseline|Total|Total of all reporting groups
11185024|NCT02092350|FG000|Participant Flow|Immediate Treatment + Intensive PK|Participants received grazoprevir (GZR) 100 mg tablet + elbasvir (EBR) 50 mg tablet once daily (q.d.) by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive pharmacokinetics (PK) testing.
11185025|NCT02092350|FG001|Participant Flow|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a fixed dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
11185026|NCT02092350|OG000|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
11185027|NCT02092350|OG001|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
11185028|NCT02092350|OG001|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
11185029|NCT02092350|EG000|Reported Event|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
11185030|NCT02092350|EG001|Reported Event|Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period.
11185031|NCT02092350|EG002|Reported Event|Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks|Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
11185032|NCT02092389|BG000|Baseline|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
11185033|NCT02092389|FG000|Participant Flow|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
11185034|NCT02092389|OG000|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
11185035|NCT02092389|EG000|Reported Event|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
11185036|NCT02092415|BG000|Baseline|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
11185037|NCT02092415|FG000|Participant Flow|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
11357759|NCT03748758|OG004|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11185038|NCT02092415|OG000|Outcome|Normal Subjects Baseline Flow|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
11185039|NCT02092415|OG001|Outcome|Normal Subjects - Tourniquet Flow|Perfusion measured at time of tourniquet placement
11185040|NCT02092415|EG000|Reported Event|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
11185041|NCT02092441|BG000|Baseline|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
11185042|NCT02092441|BG001|Baseline|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
11185043|NCT02092441|BG002|Baseline|Total|Total of all reporting groups
11185044|NCT02092441|FG000|Participant Flow|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
11185045|NCT02092441|FG001|Participant Flow|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
11185046|NCT02092441|OG000|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
11185047|NCT02092441|OG001|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
11185048|NCT02092441|EG000|Reported Event|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
11185049|NCT02092441|EG001|Reported Event|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
11185050|NCT02092467|BG000|Baseline|Tofacitinib 5 mg BID|Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185051|NCT02092467|BG001|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.
11185052|NCT02092467|BG002|Baseline|TNFi|In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185053|NCT02092467|BG003|Baseline|Total|Total of all reporting groups
11185054|NCT02092467|FG000|Participant Flow|Tofacitinib 5 mg BID|Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185055|NCT02092467|FG001|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.
11185056|NCT02092467|FG002|Participant Flow|TNFi|In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185057|NCT02092467|OG000|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185058|NCT02092467|OG001|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.
11185059|NCT02092467|OG002|Outcome|All Tofacitinib|All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185060|NCT02092467|OG003|Outcome|TNFi|In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185061|NCT02092467|OG002|Outcome|TNFi|In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185062|NCT02092467|EG000|Reported Event|Tofacitinib 5 mg BID|Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11185063|NCT02092467|EG001|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.
11185064|NCT02092467|EG002|Reported Event|TNFi|In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
11341453|NCT03682302|FG002|Participant Flow|Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
11341454|NCT03682302|FG003|Participant Flow|Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
10961817|NCT00863057|EG003|Reported Event|Duloxetine Placebo and Methadone Placebo|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
10961818|NCT00863109|BG000|Baseline|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
10961819|NCT00863109|FG000|Participant Flow|PEG + RBV (Standard Clinical Practice)|Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
10961820|NCT00863109|OG000|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
10961821|NCT00863109|OG000|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
10961822|NCT00863109|OG001|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
10961823|NCT00863109|EG000|Reported Event|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
10961824|NCT00863122|BG000|Baseline|Lapatinib|Subjects received lapatinib for 1500 mg by mouth daily for 10 days prior to surgery for vestibular schwannoma resection
10961825|NCT00863122|BG001|Baseline|Control|Control subjects did not receive any intervention prior to surgery for vestibular schwannoma resection
11341455|NCT03682302|OG000|Outcome|Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL|"Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.~Exparel: EXPAREL 4mg/kg (maximum 266 mg)"
10961826|NCT00863122|BG002|Baseline|Total|Total of all reporting groups
10961827|NCT00863122|FG000|Participant Flow|Lapatinib|Subjects received lapatinib 1500 mg by mouth for 10 days prior to surgery for vestibular schwannoma resection.
10961828|NCT00863122|FG001|Participant Flow|Control|Control subjects did not receive any intervention prior to surgery for vestibular schwannoma resection.
10961829|NCT00863122|OG000|Outcome|Lapatinib|Subjects received lapatinib 1500 mg by mouth for 10 days prior to surgery for vestibular schwannoma resection
10961830|NCT00863122|OG000|Outcome|Lapatinib|"Subjects will receive lapatinib for 10 days prior to surgery for vestibular schwannoma resection.~lapatinib: 1500 mg lapatinib by mouth per day for 10 days"
10961831|NCT00863122|OG001|Outcome|Control|Control subjects will not receive any intervention prior to surgery for vestibular schwannoma resection. Control subjects donate tissue at the time of surgery.
10961832|NCT00863122|OG000|Outcome|NF2 Associated VS|Participants with vestibular schwannomas associated with a diagnosis of neurofibromatosis type 2
10961833|NCT00863122|OG001|Outcome|Sporadic VS|Participants with sporadic vestibular schwannomas (i.e. not associated with a diagnosis of neurofibromatosis type 2)
11341456|NCT03682302|OG001|Outcome|Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine|"Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.~0.5% Bupivacaine HCl: Bupivacaine HCl 2mg/kg"
11341457|NCT03682302|OG002|Outcome|Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL|"Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.~Exparel: EXPAREL 4mg/kg (maximum 266 mg)"
11341458|NCT03682302|OG003|Outcome|Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL|"Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.~Exparel: EXPAREL 4mg/kg (maximum 266 mg)"
11341459|NCT03682302|EG000|Reported Event|Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
11341460|NCT03682302|EG001|Reported Event|Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacaine|Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
11341461|NCT03682302|EG002|Reported Event|Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
11341462|NCT03682302|EG003|Reported Event|Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL|Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
11341463|NCT03682705|BG000|Baseline|ELS Placebo/UPA Placebo|Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11357760|NCT03748758|OG005|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11357761|NCT03748758|OG006|Outcome|Drug: Placebo/ Day 1 Baseline|0 mg per day X 14 days Drug: Placebo: Placebo
11357762|NCT03748758|OG007|Outcome|Drug: Placebo/ Day 14: 30 Mins Predose|0 mg per day X 14 days Drug: Placebo: Placebo
11185065|NCT02092610|BG000|Baseline|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
11185066|NCT02092610|BG001|Baseline|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
11185067|NCT02092610|BG002|Baseline|Total|Total of all reporting groups
11357763|NCT03748758|OG008|Outcome|Drug: Placebo/ Day 14: 5 Mins|0 mg per day X 14 days Drug: Placebo: Placebo
11357764|NCT03748758|OG009|Outcome|Drug: Placebo/ Day 14: 20 Mins|0 mg per day X 14 days Drug: Placebo: Placebo
11357765|NCT03748758|OG010|Outcome|Drug: Placebo/ Day 14: 35 Mins|0 mg per day X 14 days Drug: Placebo: Placebo
11357766|NCT03748758|OG011|Outcome|Drug: Placebo/ Day 14: 50 Mins|0 mg per day X 14 days Drug: Placebo: Placebo
11357767|NCT03748758|OG000|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11357768|NCT03748758|OG001|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11357769|NCT03748758|OG002|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11357770|NCT03748758|OG003|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11357771|NCT03748758|OG004|Outcome|Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins|Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201
11357772|NCT03748758|OG005|Outcome|Drug: Placebo/ Day 14: 30 Mins Predose|0 mg per day X 14 days Drug: Placebo: Placebo
11357773|NCT03748758|OG006|Outcome|Drug: Placebo/ Day 14: 5 Mins|0 mg per day X 14 days Drug: Placebo: Placebo
11357774|NCT03748758|OG007|Outcome|Drug: Placebo/ Day 14: 20 Mins|0 mg per day X 14 days Drug: Placebo: Placebo
11357775|NCT03748758|OG008|Outcome|Drug: Placebo/ Day 14: 35 Mins|0 mg per day X 14 days Drug: Placebo: Placebo
11357776|NCT03748758|OG009|Outcome|Drug: Placebo/ Day 14: 50 Mins|0 mg per day X 14 days Drug: Placebo: Placebo
11357777|NCT03748758|EG000|Reported Event|Drug: OP0201 Cohort A 30 mg Per Day|"Cohort A- 30 mg per day X 14 days~Drug: OP0201: Drug OP0201"
11357778|NCT03748758|EG001|Reported Event|Drug: OP0201 Cohort B 60 mg Per Day|"Cohort B-60 mg per day X 14 days~Drug: OP0201: Drug OP0201"
11357779|NCT03748758|EG002|Reported Event|Drug: Placebo|"0 mg per day X 14 days~Drug: Placebo: Placebo"
11357780|NCT03748706|BG000|Baseline|PTI-125|"PTI-125 100 mg oral tablets administered twice daily (BID)~PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days"
11357781|NCT03748706|FG000|Participant Flow|PTI-125|"PTI-125 100 mg oral tablets administered twice daily (BID)~PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days"
11357782|NCT03748706|OG000|Outcome|PTI-125|"PTI-125 100 mg oral tablets administered twice daily (BID)~PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days"
11357783|NCT03748706|EG000|Reported Event|PTI-125|"PTI-125 100 mg oral tablets administered twice daily (BID)~PTI-125, 100 mg tablets: PTI-125, 100 mg tablets taken twice a day for 28 days"
11357784|NCT03748264|BG000|Baseline|Standard of Care|All participants that were enrolled into the Standard of Care.
11357785|NCT03748264|BG001|Baseline|DreamMapper Application|All participants that were enrolled into the DreamMapper Application.
11357786|NCT03748264|BG002|Baseline|DreamMapper Application With Therapist Assist|All participants that were enrolled into the DreamMapper Application With Therapist Assist.
11357787|NCT03748264|BG003|Baseline|Total|Total of all reporting groups
11357788|NCT03748264|FG000|Participant Flow|Standard of Care|All participants enrolled in to the Standard of care.
11357789|NCT03748264|FG001|Participant Flow|DreamMapper Application|All participants that were enrolled into the DreamMapper Application.
11357790|NCT03748264|FG002|Participant Flow|DreamMapper Application With Therapist Assist|All participants that were enrolled into the DreamMapper Application With Therapist Assist.
11357791|NCT03748264|OG000|Outcome|Standard of Care|"In the standard of care or the control condition, participants will receive the sites therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. This group will use a wireless modem that is attached to the PAP device and uploads adherence and other therapy information daily to a secured database (Encore Anywhere). With this method, therapy information is not directly available to the participant. Therapy information is available continuously to site staff personnel in the standard care arm.~Standard of Care: In the standard of care or the control condition, participants will receive the sites therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. This group will use a wireless modem that is attached to the PAP device and uploads adherence and other therapy information daily to a secured database (Encore Anywhere). With this method, therapy information is not directly available to the participant but will continuously be available to site staff personnel."
11357792|NCT03748264|OG001|Outcome|DreamMapper Application|"The DreamMapper Application group will receive the site's therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. Participants in this group will also download the DreamMapper application on their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper through the application. Study personnel will have access to adherence and therapy information continuously as well~DreamMapper Application: The DreamMapper application condition will receive the site's therapy initiation standard of care and will also download the DreamMapper application on their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper through the application. Study personnel will have access to adherence and therapy information continuously."
11357793|NCT03748264|OG002|Outcome|DreamMapper Application With Therapist Assist|"The DreamMapper Application wit Therapist Assist group will not receive the site's therapy initiation standard of care but will review the Therapist Assist automated educational material on Obstructive Sleep Apnea, and their Philips Respironics mask. and DreamMapper. These participants will download the DreamMapper application onto their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper. Study personnel will have access to adherence and therapy information continuously as well~DreamMapper Application with Therapist Assist: The DreamMapper with Therapist Assist will review the Therapist Assist automated educational material on Obstructive Sleep Apnea, their Philips Respironics mask and DreamMapper. These participants will download the DreamMapper application onto their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper. Study personnel will have access to adherence and therapy information continuously."
11357794|NCT03748264|EG000|Reported Event|Standard of Care|In the standard of care or the control condition, participants will receive the sites therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. This group will use a wireless modem that is attached to the PAP device and uploads adherence and other therapy information daily to a secured database (Encore Anywhere). With this method, therapy information is not directly available to the participant. Therapy information is available continuously to site staff personnel in the standard care arm.Standard of Care: In the standard of care or the control condition, participants will receive the sites therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. This group will use a wireless modem that is attached to the PAP device and uploads adherence and other therapy information daily to a secured database (Encore Anywhere). With this method, therapy information is not directly available to the participant but will continuously be available to site staff personnel.
11357795|NCT03748264|EG001|Reported Event|DreamMapper|The DreamMapper Application group will receive the site's therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. Participants in this group will also download the DreamMapper application on their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper through the application. Study personnel will have access to adherence and therapy information continuously as wellDreamMapper Application: The DreamMapper application condition will receive the site's therapy initiation standard of care and will also download the DreamMapper application on their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper through the application. Study personnel will have access to adherence and therapy information continuously.
11357796|NCT03748264|EG002|Reported Event|DreamMapper Application With Therapist Assist|The DreamMapper Application wit Therapist Assist group will not receive the site's therapy initiation standard of care but will review the Therapist Assist automated educational material on Obstructive Sleep Apnea, and their Philips Respironics mask. and DreamMapper. These participants will download the DreamMapper application onto their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper. Study personnel will have access to adherence and therapy information continuously as wellDreamMapper Application with Therapist Assist: The DreamMapper with Therapist Assist will review the Therapist Assist automated educational material on Obstructive Sleep Apnea, their Philips Respironics mask and DreamMapper. These participants will download the DreamMapper application onto their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper. Study personnel will have access to adherence and therapy information continuously.
11357797|NCT03747497|BG000|Baseline|Contezolid Acefosamil|Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h
11357798|NCT03747497|BG001|Baseline|Linezolid|Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
11357799|NCT03747497|BG002|Baseline|Total|Total of all reporting groups
11357800|NCT03747497|FG000|Participant Flow|Contezolid Acefosamil|Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h
10961834|NCT00863122|OG000|Outcome|Participants With Tissue Available for Gene Mutation Analysis|Seven participants had successful NF2 gene mutation analysis via exon scanning and MLPA.
11236614|NCT02450526|OG001|Outcome|Dysport® 50 U, Cycle 3 (OL Period)|"All subjects who were eligible for retreatment following Cycle 2 entered Cycle 3 and received OL Dysport® 50 U. The total treatment dose was injected in 5 predefined sites across the glabellar region on Cycle 3 Day 1.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57, and 85 of Cycle 3. Subjects were assessed for the eligibility to receive the next treatment cycle from Day 85.~Any subjects who were not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study when they had either received a total of five study treatment injections or completed a total of 15 months follow-up in the study following the first study treatment administration and completed the Day 85 visit following the last injection."
11236615|NCT02450526|OG002|Outcome|Dysport® 50 U, Cycle 4 (OL Period)|"All subjects who were eligible for retreatment following Cycle 3 entered Cycle 4 and received OL Dysport® 50 U. The total treatment dose was injected in 5 predefined sites across the glabellar region on Cycle 4, Day 1.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57, and 85 of Cycle 4. Subjects were assessed for the eligibility to receive the next treatment cycle from Day 85.~Any subjects who were not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study when they had either received a total of five study treatment injections or completed a total of 15 months follow-up in the study following the first study treatment administration and completed the Day 85 visit following the last injection."
11236616|NCT02450526|OG003|Outcome|Dysport® 50 U, Cycle 5 (OL Period)|"All subjects who were eligible for retreatment following Cycle 4 entered Cycle 5 and received OL Dysport® 50 U. The total treatment dose was injected in 5 predefined sites across the glabellar region on Cycle 5, Day 1.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57, and 85 of Cycle 5. A subject was considered to have completed the study when they had either received a total of five study treatment injections or completed a total of 15 months follow-up in the study following the first study treatment administration and completed the Day 85 visit following the last injection."
11236617|NCT02450526|OG000|Outcome|Dysport® 50 U, Cycle 2 (OL Period)|"All subjects who were eligible for retreatment following the DB period entered Cycle 2 and received OL Dysport® 50 U. The total treatment dose was injected in 5 predefined sites across the glabellar region on Cycle 2 Day 1.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57, and 85 of Cycle 2. Subjects were assessed for the eligibility to receive the next treatment cycle from Day 85.~Any subjects who were not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study when they had either received a total of five study treatment injections or completed a total of 15 months follow-up in the study following the first study treatment administration and completed the Day 85 visit following the last injection."
11236618|NCT02450526|EG000|Reported Event|Dysport® 50 U - DB Period|"Subjects randomised to the Dysport® treatment group in Cycle 1 received on Day 1, 50 U (0.25 mL), divided into five injections into the glabellar area. 10 U (0.05 mL) of Dysport® was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236619|NCT02450526|EG001|Reported Event|Dysport® Placebo - DB Period|"Subjects randomised to the Dysport® placebo group in Cycle 1 received on Day 1, 0.25 mL, divided into five injections into the glabellar area. 0.05 mL of Dysport® placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236620|NCT02450526|EG002|Reported Event|Botox 20 U - DB Period|"Subjects randomised to the Botox treatment group in Cycle 1 received on Day 1, 20 U (0.5 mL), divided into five injections into the glabellar area. 4 U (0.1 mL) of Botox was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1"
11337722|NCT03592745|BG001|Baseline|Sham tVNS + Robotic Arm Therapy|"Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.~Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control."
10961835|NCT00863122|EG000|Reported Event|Lapatinib|Subjects received lapatinib 1500 mg by mouth for 10 days prior to surgery for vestibular schwannoma resection.
11185068|NCT02092610|FG000|Participant Flow|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
11185069|NCT02092610|FG001|Participant Flow|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
11185070|NCT02092610|OG000|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
11185071|NCT02092610|OG001|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
11185072|NCT02092610|EG000|Reported Event|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
11185073|NCT02092610|EG001|Reported Event|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
11185074|NCT02092649|BG000|Baseline|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
11185075|NCT02092649|BG001|Baseline|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
11185076|NCT02092649|BG002|Baseline|Total|Total of all reporting groups
11185077|NCT02092649|FG000|Participant Flow|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
11185078|NCT02092649|FG001|Participant Flow|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
11185079|NCT02092649|OG000|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
11185080|NCT02092649|OG001|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
11185081|NCT02092649|EG000|Reported Event|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
11185082|NCT02092649|EG001|Reported Event|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
11185083|NCT02092662|BG000|Baseline|Study|patients after a stroke
11185084|NCT02092662|BG001|Baseline|Control|healthy volunteers
11185085|NCT02092662|BG002|Baseline|Total|Total of all reporting groups
11185086|NCT02092662|FG000|Participant Flow|Patients After a Stroke|Patients who admitted to the hospital for rehabilitation after a stroke
11185087|NCT02092662|FG001|Participant Flow|Control|Healthy voluntiers
11185088|NCT02092662|OG000|Outcome|Study Group (T1)|Patients after a stroke
11185089|NCT02092662|OG001|Outcome|Control|Healthy age-matched
11185090|NCT02092662|OG000|Outcome|Stroke|"Stroke patients at the subacute phase~stroke: task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context."
11185091|NCT02092662|OG001|Outcome|Healthy Controls|"healthy age-matched voluntiers~Healthy controls: no treatment~Deltoid onset time 0.79 sec"
11185092|NCT02092662|EG000|Reported Event|Study|Patients after a stroke
11185093|NCT02092857|BG000|Baseline|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
11185094|NCT02092857|BG001|Baseline|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
11185095|NCT02092857|BG002|Baseline|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
11185096|NCT02092857|BG003|Baseline|Total|Total of all reporting groups
11185097|NCT02092857|FG000|Participant Flow|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
11185098|NCT02092857|FG001|Participant Flow|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
11185099|NCT02092857|FG002|Participant Flow|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
11185100|NCT02092857|OG000|Outcome|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
11185101|NCT02092857|OG001|Outcome|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
11185102|NCT02092857|OG002|Outcome|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
11337723|NCT03592745|BG002|Baseline|Total|Total of all reporting groups
11357801|NCT03747497|FG001|Participant Flow|Linezolid|Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
11357802|NCT03747497|OG000|Outcome|Contezolid Acefosamil|Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h
11357803|NCT03747497|OG001|Outcome|Linezolid|Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
11357804|NCT03747497|EG000|Reported Event|Contezolid Acefosamil|Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h
11357805|NCT03747497|EG001|Reported Event|Linezolid|Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h
11357806|NCT03746405|BG000|Baseline|Repetitive TMS (rTMS)|"excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided)~repetitive transcranial magnetic stimulation: excitatory 5Hz rTMS will be used"
11357807|NCT03746405|BG001|Baseline|Sham Repetitive TMS (rTMS)|"electrical sham coil applied over the medial prefrontal cortex (fMRI-guided)~Sham repetitive transcranial magnetic stimulation: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11357808|NCT03746405|BG002|Baseline|Total|Total of all reporting groups
11357809|NCT03746405|FG000|Participant Flow|Repetitive TMS (rTMS)|"excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided)~repetitive transcranial magnetic stimulation: excitatory 5Hz rTMS will be used"
11357810|NCT03746405|FG001|Participant Flow|Sham Repetitive TMS (rTMS)|"electrical sham coil applied over the medial prefrontal cortex (fMRI-guided)~Sham repetitive transcranial magnetic stimulation: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11357811|NCT03746405|OG000|Outcome|Repetitive TMS (rTMS)|"excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided)~repetitive transcranial magnetic stimulation: excitatory 5Hz rTMS will be used"
11357812|NCT03746405|OG001|Outcome|Sham Repetitive TMS (rTMS)|"electrical sham coil applied over the medial prefrontal cortex (fMRI-guided)~Sham repetitive transcranial magnetic stimulation: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11357813|NCT03746405|EG000|Reported Event|Repetitive TMS (rTMS)|"excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided)~repetitive transcranial magnetic stimulation: excitatory 5Hz rTMS will be used"
11357814|NCT03746405|EG001|Reported Event|Sham Repetitive TMS (rTMS)|"electrical sham coil applied over the medial prefrontal cortex (fMRI-guided)~Sham repetitive transcranial magnetic stimulation: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used"
11357815|NCT03745937|BG000|Baseline|Placebo Cohort 1|Participants received subcutaneous (SC) dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week treatment extension period (TEP).
11357816|NCT03745937|BG001|Baseline|MEDI0382 Cohort 1|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
11357817|NCT03745937|BG002|Baseline|Placebo Cohort 2|Participants received SC dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.
11357818|NCT03745937|BG003|Baseline|MEDI0382 Cohort 2|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
11357819|NCT03745937|BG004|Baseline|Total|Total of all reporting groups
11357820|NCT03745937|FG000|Participant Flow|Placebo Cohort 1|Participants received subcutaneous (SC) dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week treatment extension period (TEP).
11357821|NCT03745937|FG001|Participant Flow|MEDI0382 Cohort 1|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
11357822|NCT03745937|FG002|Participant Flow|Placebo Cohort 2|Participants received SC dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.
11357823|NCT03745937|FG003|Participant Flow|MEDI0382 Cohort 2|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
11357824|NCT03745937|OG000|Outcome|Placebo Cohort 1|Participants received subcutaneous (SC) dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week treatment extension period (TEP).
11357825|NCT03745937|OG001|Outcome|MEDI0382 Cohort 1|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
11357826|NCT03745937|OG002|Outcome|Placebo Cohort 2|Participants received SC dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.
11357827|NCT03745937|OG003|Outcome|MEDI0382 Cohort 2|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
11357828|NCT03745937|OG000|Outcome|MEDI0382 (Cohort 1 + Cohort 2)|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP, in both Cohorts 1 and 2.
11357829|NCT03745937|EG000|Reported Event|Placebo Cohort 1|Participants received subcutaneous (SC) dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week treatment extension period (TEP).
11357830|NCT03745937|EG001|Reported Event|MEDI0382 Cohort 1|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
11357831|NCT03745937|EG002|Reported Event|Placebo Cohort 2|Participants received SC dose of placebo matched to MEDI0382 once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.
11357832|NCT03745937|EG003|Reported Event|MEDI0382 Cohort 2|Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP.
11357833|NCT03745222|BG000|Baseline|Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab|Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357834|NCT03745222|BG001|Baseline|Placebo + Concurrent Chemoradiotherapy -Tislelizumab|Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357835|NCT03745222|BG002|Baseline|Placebo + Concurrent Chemoradiotherapy - Placebo|Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357836|NCT03745222|BG003|Baseline|Total|Total of all reporting groups
11357837|NCT03745222|FG000|Participant Flow|Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab|Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357838|NCT03745222|FG001|Participant Flow|Placebo + Concurrent Chemoradiotherapy -Tislelizumab|Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357839|NCT03745222|FG002|Participant Flow|Placebo + Concurrent Chemoradiotherapy - Placebo|Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357840|NCT03745222|OG000|Outcome|Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab|Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357841|NCT03745222|OG001|Outcome|Placebo + Concurrent Chemoradiotherapy -Tislelizumab|Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357842|NCT03745222|OG002|Outcome|Placebo + Concurrent Chemoradiotherapy - Placebo|Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357843|NCT03745222|EG000|Reported Event|Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab|Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357844|NCT03745222|EG001|Reported Event|Placebo + Concurrent Chemoradiotherapy -Tislelizumab|Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357845|NCT03745222|EG002|Reported Event|Placebo + Concurrent Chemoradiotherapy - Placebo|Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
11357846|NCT03745092|BG000|Baseline|NBO Group|"Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.~normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa)."
11357847|NCT03745092|BG001|Baseline|Control Group|"Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.~room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention."
11357848|NCT03745092|BG002|Baseline|Total|Total of all reporting groups
11357849|NCT03745092|FG000|Participant Flow|NBO Group|"Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.~normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa)."
11357850|NCT03745092|FG001|Participant Flow|Control Group|"Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.~room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention."
11185103|NCT02092857|EG000|Reported Event|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
11185104|NCT02092857|EG001|Reported Event|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
11185105|NCT02092857|EG002|Reported Event|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
11185106|NCT02092909|BG000|Baseline|IMO-8400 0.6 mg/kg 1x/wk|IMO-8400 0.6 mg/kg once weekly s.c.
11185107|NCT02092909|BG001|Baseline|IMO-8400 1.2 mg/kg 1x/wk|IMO-8400 1.2 mg/kg once weekly s.c.
11185108|NCT02092909|BG002|Baseline|IMO-8400 1.2 mg/kg 2x/wk|IMO-8400 1.2 mg/kg twice weekly s.c.
11185109|NCT02092909|BG003|Baseline|IMO-8400 2.4 mg/kg 1x/wk|IMO-8400 2.4 mg/kg once weekly s.c.
11185110|NCT02092909|BG004|Baseline|Total|Total of all reporting groups
11185111|NCT02092909|FG000|Participant Flow|IMO-8400 0.6 mg/kg 1x/wk|IMO-8400 0.6 mg/kg once weekly s.c.
11185112|NCT02092909|FG001|Participant Flow|IMO-8400 1.2 mg/kg 1x/wk|IMO-8400 1.2 mg/kg once weekly s.c.
11185113|NCT02092909|FG002|Participant Flow|IMO-8400 1.2 mg/kg 2x/wk|IMO-8400 1.2 mg/kg twice weekly s.c.
11185114|NCT02092909|FG003|Participant Flow|IMO-8400 2.4 mg/kg 1x/wk|IMO-8400 2.4 mg/kg once weekly s.c.
11185115|NCT02092909|OG000|Outcome|IMO-8400 0.6 mg/kg 1x/wk|IMO-8400 0.6 mg/kg once weekly s.c.
11185116|NCT02092909|OG001|Outcome|IMO-8400 1.2 mg/kg 1x/wk|IMO-8400 1.2 mg/kg once weekly s.c.
11185117|NCT02092909|OG002|Outcome|IMO-8400 1.2 mg/kg 2x/wk|IMO-8400 1.2 mg/kg twice weekly s.c.
11185118|NCT02092909|OG003|Outcome|IMO-8400 2.4 mg/kg 1x/wk|IMO-8400 2.4 mg/kg once weekly s.c.
11185119|NCT02092909|EG000|Reported Event|IMO-8400 0.6 mg/kg 1x/wk|IMO-8400 0.6 mg/kg once weekly s.c.
11185120|NCT02092909|EG001|Reported Event|IMO-8400 1.2 mg/kg 1x/wk|IMO-8400 1.2 mg/kg once weekly s.c.
11185121|NCT02092909|EG002|Reported Event|IMO-8400 1.2 mg/kg 2x/wk|IMO-8400 1.2 mg/kg twice weekly s.c.
11185122|NCT02092909|EG003|Reported Event|IMO-8400 2.4 mg/kg 1x/wk|IMO-8400 2.4 mg/kg once weekly s.c.
11185123|NCT02092961|BG000|Baseline|FOSTA 100 MG PO BID|Dosing Group A
11185124|NCT02092961|BG001|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
11185125|NCT02092961|BG002|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
11185126|NCT02092961|BG003|Baseline|Total|Total of all reporting groups
11185127|NCT02092961|FG000|Participant Flow|FOSTA 100 MG PO BID|Dosing Group A
11185128|NCT02092961|FG001|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
11185129|NCT02092961|FG002|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
11185130|NCT02092961|OG000|Outcome|FOSTA 100 MG PO BID|Dosing Group A
11185131|NCT02092961|OG001|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
11185132|NCT02092961|OG002|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
11185133|NCT02092961|EG000|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
11185134|NCT02092961|EG001|Reported Event|FOSTA 100 MG BID|Dosing Group A
11185135|NCT02092961|EG002|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
11185136|NCT02092961|EG003|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
11185137|NCT02092987|BG000|Baseline|NYU Caregiver Intervention|"The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is ad hoc counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide."
11185138|NCT02092987|BG001|Baseline|REACH OUT|"All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a"
11185139|NCT02092987|BG002|Baseline|Total|Total of all reporting groups
11185140|NCT02092987|FG000|Participant Flow|NYU Caregiver Intervention|"The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is ad hoc counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services~Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide."
11191658|NCT02132910|FG001|Participant Flow|Control Group 2|"First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use.~You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level.~At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.~At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health."
11185141|NCT02092987|FG001|Participant Flow|REACH OUT|"All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a"
11185142|NCT02092987|OG000|Outcome|NYU Caregiver Intervention|"The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is ad hoc counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide."
11185143|NCT02092987|OG001|Outcome|REACH OUT|"All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a"
11185144|NCT02092987|OG000|Outcome|NYU Caregiver Intervention|"The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is ad hoc counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services~Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide."
11185145|NCT02092987|OG000|Outcome|NYU Caregiver Intervention|"This arm received the NYU counseling intervention in addition to social work support and educational material~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services~Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide."
11185146|NCT02092987|OG001|Outcome|REACH OUT|This arm received the REACH OUT counseling intervention in addition to social work support and educational material
11185147|NCT02092987|EG000|Reported Event|NYU Caregiver Intervention|"The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is ad hoc counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services~Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide."
11185148|NCT02092987|EG001|Reported Event|REACH OUT|"All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.~Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a"
11337724|NCT03592745|FG000|Participant Flow|Active tVNS + Robotic Arm Therapy|"Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.~Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear."
11236621|NCT02450526|EG003|Reported Event|Botox Placebo - DB Period|"Subjects randomised to the Botox placebo group in Cycle 1 received on Day 1, 0. 5 mL, divided into five injections into the glabellar area. 0.1 mL of Botox placebo was administered intramuscularly, at right angles to the skin into each of the five injection sites. The Investigator was blinded with respect to treatment injection.~Following treatment administration, all subjects attended follow-up visits on Days 8, 29, 57 and 85 of Cycle 1. On Day 85, subjects were assessed for their eligibility to enter the OL period (Cycles 2 to 5). Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study. A subject was considered to have completed the study in Cycle 1 if they were not eligible for retreatment and had completed a total of 15 months follow-up following study treatment administration on Day 1."
11236622|NCT02450526|EG004|Reported Event|Dysport® 50 U - OL Period|"After the first treatment cycle, all eligible subjects entered the OL period and received Dysport® 50 U (0.25 mL), injected into five predefined sites across the glabellar region. 10 U (0.05 mL) of Dysport® was administered intramuscularly, at right angles to the skin into each of the five injection sites per treatment cycle.~Subjects received a maximum of four treatment cycles (Cycles 2 to 5) with Dysport®. These cycles occurred at intervals of no less than 84 days (12 weeks) between each cycle, depending upon individual duration of response to Dysport® treatment. Any subjects not eligible for retreatment were evaluated every 28 days at additional follow-up visits until they were eligible for retreatment or had completed the study"
11236623|NCT02450539|BG000|Baseline|Abemaciclib|200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236624|NCT02450539|BG001|Baseline|Docetaxel|75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236625|NCT02450539|BG002|Baseline|Total|Total of all reporting groups
11236626|NCT02450539|FG000|Participant Flow|Abemaciclib|200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236627|NCT02450539|FG001|Participant Flow|Docetaxel|75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236628|NCT02450539|OG000|Outcome|Abemaciclib|200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236629|NCT02450539|OG001|Outcome|Docetaxel|75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236630|NCT02450539|OG000|Outcome|Abemaciclib|200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle.
11236631|NCT02450539|OG000|Outcome|Abemaciclib|200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236632|NCT02450539|OG001|Outcome|Docetaxel|75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236633|NCT02450539|EG000|Reported Event|Abemaciclib|200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236634|NCT02450539|EG001|Reported Event|Docetaxel|75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11236635|NCT02450552|BG000|Baseline|Oral Ezogabine 900 mg/Day|Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
11236636|NCT02450552|BG001|Baseline|Oral Ezogabine 600 mg/Day|Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
11236637|NCT02450552|BG002|Baseline|Placebo|Placebo: Matched placebo
11236638|NCT02450552|BG003|Baseline|Total|Total of all reporting groups
11236639|NCT02450552|FG000|Participant Flow|Oral Ezogabine 900 mg/Day|Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
11236640|NCT02450552|FG001|Participant Flow|Oral Ezogabine 600 mg/Day|Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
11236641|NCT02450552|FG002|Participant Flow|Placebo|Placebo: Matched placebo
11236642|NCT02450552|OG000|Outcome|Oral Ezogabine 900 mg/Day|Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
11236643|NCT02450552|OG001|Outcome|Oral Ezogabine 600 mg/Day|Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
11236644|NCT02450552|OG002|Outcome|Placebo|Placebo: Matched placebo
11236645|NCT02450552|EG000|Reported Event|Oral Ezogabine 900 mg/Day|Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
11236646|NCT02450552|EG001|Reported Event|Oral Ezogabine 600 mg/Day|Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
11236647|NCT02450552|EG002|Reported Event|Placebo|Placebo: Matched placebo
11236648|NCT02450578|BG000|Baseline|Cohort 1A: 400 mg DSM265, Sporozoite Challenge|"DSM265 400 mg on Day -1, sporozoite challenge on Day 0~DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11357851|NCT03745092|OG000|Outcome|NBO Group|"Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.~normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa)."
11357852|NCT03745092|OG001|Outcome|Control Group|"Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.~room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention."
11357853|NCT03745092|EG000|Reported Event|NBO Group|"Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.~normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa)."
11357854|NCT03745092|EG001|Reported Event|Control Group|"Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.~room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention."
11357855|NCT03744780|BG000|Baseline|ACT Workshop for Emotional Eating|All participants were assigned to an ACT workshop designed to reduce emotional eating through the teaching of three skills: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness.
11357856|NCT03744780|FG000|Participant Flow|ACT Workshop for Emotional Eating|All participants were assigned to an ACT workshop designed to reduce emotional eating through the teaching of three skills: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness.
11357857|NCT03744780|OG000|Outcome|ACT Workshop for Emotional Eating|All participants were assigned to an ACT workshop designed to reduce emotional eating through the teaching of three skills: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness.
11357858|NCT03744780|EG000|Reported Event|ACT Workshop for Emotional Eating|All participants were assigned to an ACT workshop designed to reduce emotional eating through the teaching of three skills: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness.
11357859|NCT03743311|BG000|Baseline|Conservative Treatment of Hemmorhoid|"Patients taken conservative treatment (Detralex)~Detralex: Conservative treatment of Hemorhoid"
11357860|NCT03743311|BG001|Baseline|Combined Treatment of Hemmorhoid|"Combined treatment patients (surgery and conservative treatment)~Combined therapy: Surgical + conservative treatment of Hemorhoid"
11357861|NCT03743311|BG002|Baseline|Surgical Treatment of Hemmorhoid|"Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)~Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid"
11357862|NCT03743311|BG003|Baseline|Total|Total of all reporting groups
11357863|NCT03743311|FG000|Participant Flow|Conservative Treatment of Hemmorhoid|"Patients taken conservative treatment (Detralex)~Detralex: Conservative treatment of Hemorhoid"
11357864|NCT03743311|FG001|Participant Flow|Combined Treatment of Hemmorhoid|"Combined treatment patients (surgery and conservative treatment)~Combined therapy: Surgical + conservative treatment of Hemorhoid"
11357865|NCT03743311|FG002|Participant Flow|Surgical Treatment of Hemmorhoid|"Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)~Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid"
11357866|NCT03743311|OG000|Outcome|Surgical Treatment of Hemmorhoid|"Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)~Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid"
11357867|NCT03743311|OG001|Outcome|Conservative Treatment of Hemmorhoid|"Patients taken conservative treatment (Detralex)~Detralex: Conservative treatment of Hemorhoid"
11357868|NCT03743311|OG002|Outcome|Combined Treatment of Hemmorhoid|"Combined treatment patients (surgery and conservative treatment)~Combined therapy: Surgical + conservative treatment of Hemorhoid"
11357869|NCT03743311|OG000|Outcome|All Patients Suffering From Acute or Chronic Hemorrhoids Within 1 Month After Presenting to a Doctor|All groups of patients suffering from acute or chronic hemorrhoids within 1 month after presenting to a doctor (medical therapy, minimally invasive procedures, and surgical interventions)
11357870|NCT03743311|EG000|Reported Event|Conservative Treatment of Hemmorhoid|"Patients taken conservative treatment (Detralex)~Detralex: Conservative treatment of Hemorhoid"
11357871|NCT03743311|EG001|Reported Event|Combined Treatment of Hemmorhoid|"Combined treatment patients (surgery and conservative treatment)~Combined therapy: Surgical + conservative treatment of Hemorhoid"
11357872|NCT03743311|EG002|Reported Event|Surgical Treatment of Hemmorhoid|"Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)~Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid"
11357873|NCT03743038|BG000|Baseline|Overall|Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks on one side of the face.
11357874|NCT03743038|FG000|Participant Flow|Overall|Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks.
11357875|NCT03743038|OG000|Outcome|FMX101 Oil Vehicle (A)|Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.
11357876|NCT03743038|OG001|Outcome|Hydro-alcohol Vehicle (B)|Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
11357877|NCT03743038|OG000|Outcome|Overall|Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks.
11357878|NCT03743038|EG000|Reported Event|Overall|Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks.
11357879|NCT03742973|BG000|Baseline|Placebo Cohort A|Participants received placebo orally once a day for 12 weeks.
11357880|NCT03742973|BG001|Baseline|.Baricitinib Cohort A|Participants received 2 mg of Baricitinib tablet orally once a day for 12 weeks.
11357881|NCT03742973|BG002|Baseline|Total|Total of all reporting groups
11357882|NCT03742973|FG000|Participant Flow|Baricitinib Cohort A|Participants received 2 milligram (mg) of Baricitinib tablet orally once a day for 12 weeks.
11357883|NCT03742973|FG001|Participant Flow|Placebo Cohort A|Participants received placebo orally once a day for 12 weeks.
11357884|NCT03742973|OG000|Outcome|Baricitinib Cohort A|Participants received 2 mg of Baricitinib tablet orally once a day for 12 weeks.
11357885|NCT03742973|OG001|Outcome|Placebo Cohort A|Participants received placebo orally once a day for 12 weeks.
11357886|NCT03742973|EG000|Reported Event|Baricitinib Cohort A|Participants received 2 mg of Baricitinib tablet orally once a day for 12 weeks.
11357887|NCT03742973|EG001|Reported Event|Placebo Cohort A|Participants received placebo orally once a day for 12 weeks.
11357888|NCT03742440|BG000|Baseline|GrafixPL PRIME|"Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.~GrafixPL PRIME: GrafixPL PRIME"
11357889|NCT03742440|FG000|Participant Flow|GrafixPL PRIME|"Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.~GrafixPL PRIME: GrafixPL PRIME"
11357890|NCT03742440|OG000|Outcome|GrafixPL PRIME|"Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.~GrafixPL PRIME: GrafixPL PRIME"
11357891|NCT03742440|EG000|Reported Event|GrafixPL PRIME|"Open-label case series to evaluate GrafixPL PRIME. All subjects received the product.~GrafixPL PRIME: GrafixPL PRIME"
11357892|NCT03742427|BG000|Baseline|Effect of C-collar in Optic Nerve Sheath Diameter|"Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography~ultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes"
11357893|NCT03742427|FG000|Participant Flow|Effect of C-collar in Optic Nerve Sheath Diameter|"Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography~ultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes"
11357894|NCT03742427|OG000|Outcome|Effect of C-collar in Optic Nerve Sheath Diameter|"Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography~ultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes"
11357895|NCT03742427|EG000|Reported Event|Effect of C-collar in Optic Nerve Sheath Diameter|"Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography~ultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes"
11357896|NCT03742271|BG000|Baseline|All Dispensed Subjects|All subjects dispensed the senofilcon A lens during any point in the study.
11357897|NCT03742271|FG000|Participant Flow|Senofilcon A|All subjects wore the senofilcon A lens for the first 4-Weeks of the study and then wore their Habitual spectacles for a period of 1-Week after the 4-Weeks of lens wear.
11357898|NCT03742271|OG000|Outcome|Senofilcon A|All subjects in this study wore the senofilcon A lens in both eyes through the 4-Week follow-up evaluation
11357899|NCT03742271|EG000|Reported Event|Senofilcon A|All subjects that wore the senofilcon A lens in either eye during any point of the study.
11357900|NCT03742154|BG000|Baseline|Varenicline Group|"50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.~Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills"
11357901|NCT03742154|BG001|Baseline|Control Group|50 participants will be enrolled in this group.
11357902|NCT03742154|BG002|Baseline|Total|Total of all reporting groups
11357903|NCT03742154|FG000|Participant Flow|Varenicline Group|"50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.~Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills"
11357904|NCT03742154|FG001|Participant Flow|Control Group|49 participants will be enrolled in this group.
11357905|NCT03742154|OG000|Outcome|Varenicline Group|"50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.~Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills"
11357906|NCT03742154|OG001|Outcome|Control Group|50 participants will be enrolled in this group.
11357907|NCT03742154|EG000|Reported Event|Varenicline Group|"50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.~Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills"
11357908|NCT03742154|EG001|Reported Event|Control Group|49 participants will be enrolled in this group.
11357909|NCT03741725|BG000|Baseline|Pay-it-forward|Men in pay-it-forward were told that the standard price of the gonorrhea and chlamydia testing was 150RMB ($22US), and that previous participants who cared about them donated toward testing fees. Thus, men in the pay-it-forward arm received a free test, and then decided whether, and if so how much to donate toward future testing for others. Participants were shown postcards and told that testing and donating were voluntary.
11357910|NCT03741725|BG001|Baseline|Pay-what-you-want|After being introduced to the testing and the study, men in the pay-what-you-want arm were told that the standard price of gonorrhea and chlamydia testing was 150RMB ($22US), and that they would receive free testing and then decide the amount that they would like to pay for their own test.
11357911|NCT03741725|BG002|Baseline|Standard-of-care|Men in the standard of care arm received the same introduction to gonorrhea and chlamydia testing as the men in the other two arms. They were then told that the standard price of gonorrhea and chlamydia testing was 150RMB (US$22) and they had to pay the full amount for the their testing.
11357912|NCT03741725|BG003|Baseline|Total|Total of all reporting groups
11236649|NCT02450578|BG001|Baseline|Cohort 1B: Malarone, Sporozoite Challenge|"Malarone daily for 9 days from Day -1 to Day 7, sporozoite challenge Day 0~Malarone: 250 mg atovaquone, 100 mg proguanil hydrochloride~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236650|NCT02450578|BG002|Baseline|Cohort 2: 400 mg DSM265, Sporozoite Challenge|"DSM265 400 mg on Day -7, sporozoite challenge on Day 0~DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236651|NCT02450578|BG003|Baseline|Placebo Cohorts 1A and 2|"Placebo to DSM265 400 mg on Day -7, sporozoite challenge on Day 0~Placebo to DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236652|NCT02450578|BG004|Baseline|Total|Total of all reporting groups
11236653|NCT02450578|FG000|Participant Flow|Cohort 1A: 400 mg DSM265, Sporozoite Challenge|"DSM265 400mg on Day -1, sporozoite challenge on Day 0~DSM265 400mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236654|NCT02450578|FG001|Participant Flow|Cohort 1B: Malarone, Sporozoite Challenge|"Malarone daily for 9 days from Day -1 to Day 7, sporozoite challenge Day 0~Malarone: 250 mg atovaquone, 100 mg proguanil hydrochloride~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236655|NCT02450578|FG002|Participant Flow|Cohort 2: 400 mg DSM265, Sporozoite Challenge|"DSM265 400mg on Day -7, sporozoite challenge on Day 0~DSM265 400mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236656|NCT02450578|FG003|Participant Flow|Placebo Cohorts 1A and 2, Sporozoite Challenge|"Placebo to DSM265 400 mg on Day -1, sporozoite challenge on Day 0~Placebo: Single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236657|NCT02450578|OG000|Outcome|Cohort 1A: 400 mg DSM265 (Day-1), Sporozoite Challenge (Day0)|"DSM265 400 mg on Day -1, sporozoite challenge on Day 0~DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236658|NCT02450578|OG001|Outcome|Cohort 1B: Malarone, Sporozoite Challenge|"Malarone daily for 9 days from Day -1 to Day 7, sporozoite challenge Day 0~Malarone: 250 mg atovaquone, 100 mg proguanil hydrochloride~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236659|NCT02450578|OG002|Outcome|Cohort 2: 400 mg DSM265 (Day-7), Sporozoite Challenge (Day0)|"DSM265 400 mg on Day -7, sporozoite challenge on Day 0~DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236660|NCT02450578|OG003|Outcome|Placebo Cohorts 1A and 2|"Placebo to DSM265 400 mg on Day -7 or Day -1, sporozoite challenge on Day 0~Placebo to DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236661|NCT02450578|OG000|Outcome|Cohort 1a: DSM265/Placebo, Sporozoite Inoculum|"DSM265 400mg / placebo Day -1, sporozoite inoculum Day 0~DSM265 400mg: DSM265 400mg, single oral administration in a fed state~Placebo to DSM265 400 mg: Placebo to DSM265 400mg, single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: IV Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236662|NCT02450578|OG001|Outcome|Cohort 2: DSM265/Placebo, Sporozoite Inoculum|"DSM265 400mg / placebo Day -7, sporozoite inoculum Day 0~DSM265 400mg: DSM265 400mg, single oral administration in a fed state~Placebo to DSM265 400 mg: Placebo to DSM265 400mg, single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: IV Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236663|NCT02450578|OG000|Outcome|Cohort 1B: Malarone, Sporozoite Challenge|"Malarone daily for 9 days from Day -1 to Day 7, sporozoite challenge Day 0~Malarone: 250 mg atovaquone, 100 mg proguanil hydrochloride~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236664|NCT02450578|OG001|Outcome|Cohort 2: 400 mg DSM265 (Day-7), Sporozoite Challenge (Day0)|"DSM265 400 mg on Day -7, sporozoite challenge on Day 0~DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236665|NCT02450578|EG000|Reported Event|Cohort 1A: 400 mg DSM265 (Day-1), Sporozoite Challenge (Day0)|"DSM265 400 mg on Day -1, sporozoite challenge on Day 0~DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236666|NCT02450578|EG001|Reported Event|Cohort 1B: Malarone, Sporozoite Challenge|"Malarone daily for 9 days from Day -1 to Day 7, sporozoite challenge Day 0~Malarone: 250 mg atovaquone, 100 mg proguanil hydrochloride~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236667|NCT02450578|EG002|Reported Event|Cohort 2: 400 mg DSM265 (Day-7), Sporozoite Challenge (Day0)|"DSM265 400 mg on Day -7, sporozoite challenge on Day 0~DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236668|NCT02450578|EG003|Reported Event|Placebo Cohorts 1A and 2|"Placebo to DSM265 400 mg on Day -7 or Day -1, sporozoite challenge on Day 0~Placebo to DSM265 400 mg: single oral administration in a fed state~Plasmodium falciparum sporozoite challenge: Plasmodium falciparum sporozoites (3200) by direct venous inoculation"
11236669|NCT02450747|BG000|Baseline|Multi-focal(Etafilcon A)|All subjects wore the Test Contact Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
11236670|NCT02450747|FG000|Participant Flow|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
11236671|NCT02450747|OG000|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
11236672|NCT02450747|OG001|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks.
11357913|NCT03741725|FG000|Participant Flow|Pay-it-forward|"First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option.~Pay-it-forward: Participants were offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option."
11357914|NCT03741725|FG001|Participant Flow|Pay-what-you-want|"First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered gonorrhoea and chlamydia testing and told that they could decide and pay any desired amount after receiving the test.~Pay-what-you-want: Participants were offered gonorrhoea and chlamydia testing and told that they could decide and pay any desired amount after receiving the test."
11357915|NCT03741725|FG002|Participant Flow|Standard of Care|First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered gonorrhoea and chlamydia testing at the standard patient price.
11357916|NCT03741725|OG000|Outcome|Pay-it-forward|Men in pay-it-forward were told that the standard price of the gonorrhea and chlamydia testing was 150RMB ($22US), and that previous participants who cared about them donated toward testing fees. Thus, men in the pay-it-forward arm received a free test, and then decided whether, and if so how much to donate toward future testing for others. Participants were shown postcards and told that testing and donating were voluntary.
11357917|NCT03741725|OG001|Outcome|Pay-what-you-want|After being introduced to the testing and the study, men in the pay-what-you-want arm were told that the standard price of gonorrhea and chlamydia testing was 150RMB ($22US), and that they would receive free testing and then decide the amount that they would like to pay for their own test.
11357918|NCT03741725|OG002|Outcome|Standard-of-care|Men in the standard of care arm received the same introduction to gonorrhea and chlamydia testing as the men in the other two arms. They were then told that the standard price of gonorrhea and chlamydia testing was 150RMB (US$22) and they had to pay the full amount for the their testing.
11357919|NCT03741725|OG000|Outcome|Pay-it-forward|"First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option.~Pay-it-forward: Participants were offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option."
11357920|NCT03741725|OG001|Outcome|Pay-what-you-want|"First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered gonorrhoea and chlamydia testing and told that they could decide and pay any desired amount after receiving the test.~Pay-what-you-want: Participants were offered gonorrhoea and chlamydia testing and told that they could decide and pay any desired amount after receiving the test."
11357921|NCT03741725|OG002|Outcome|Standard of Care|First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered gonorrhoea and chlamydia testing at the standard patient price.
11357922|NCT03741725|EG000|Reported Event|Pay-it-forward|Men in pay-it-forward were told that the standard price of the gonorrhea and chlamydia testing was 150RMB ($22US), and that previous participants who cared about them donated toward testing fees. Thus, men in the pay-it-forward arm received a free test, and then decided whether, and if so how much to donate toward future testing for others. Participants were shown postcards and told that testing and donating were voluntary.
11357923|NCT03741725|EG001|Reported Event|Pay-what-you-want|After being introduced to the testing and the study, men in the pay-what-you-want arm were told that the standard price of gonorrhea and chlamydia testing was 150RMB ($22US), and that they would receive free testing and then decide the amount that they would like to pay for their own test.
11357924|NCT03741725|EG002|Reported Event|Standard-of-care|Men in the standard of care arm received the same introduction to gonorrhea and chlamydia testing as the men in the other two arms. They were then told that the standard price of gonorrhea and chlamydia testing was 150RMB (US$22) and they had to pay the full amount for the their testing.
11357925|NCT03741088|BG000|Baseline|VORTX Rx Treatment|"Focused ultrasound ablation of liver tumors.~VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound"
11357926|NCT03741088|FG000|Participant Flow|VORTX Rx Treatment|"Focused ultrasound ablation of liver tumors.~VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound"
11357927|NCT03741088|OG000|Outcome|VORTX Rx Treatment|"Focused ultrasound ablation of liver tumors.~VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound"
11357928|NCT03741088|EG000|Reported Event|VORTX Rx Treatment|"Focused ultrasound ablation of liver tumors.~VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound"
11357929|NCT03741062|BG000|Baseline|J. Morita AdvErl Evo Er:YAG Laser|"Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s).~J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters:~Fluence = 6.3 J/cm^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s"
11357930|NCT03741062|BG001|Baseline|Control|"This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group.~Control: Sham treatment with laser unit turned off"
11357931|NCT03741062|BG002|Baseline|Total|Total of all reporting groups
11357932|NCT03741062|FG000|Participant Flow|J. Morita AdvErl Evo Er:YAG Laser|"Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s).~J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters:~Fluence = 6.3 J/cm^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s"
11357933|NCT03741062|FG001|Participant Flow|Control|"This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group.~Control: Sham treatment with laser unit turned off"
11357934|NCT03741062|OG000|Outcome|J. Morita AdvErl Evo Er:YAG Laser|"Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s).~J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters:~Fluence = 6.3 J/cm^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s"
11357935|NCT03741062|OG001|Outcome|Control|"This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group.~Control: Sham treatment with laser unit turned off"
11357936|NCT03741062|EG000|Reported Event|J. Morita AdvErl Evo Er:YAG Laser|"Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s).~J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters:~Fluence = 6.3 J/cm^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s"
11357937|NCT03741062|EG001|Reported Event|Control|"This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group.~Control: Sham treatment with laser unit turned off"
11357938|NCT03740659|BG000|Baseline|Levofloxacin + Dexamethasone|"Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.~Administration route: ocular instillation~Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP)."
11357939|NCT03740659|BG001|Baseline|Levofloxacin|"Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.~Administration route: ocular instillation~Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin)."
11357940|NCT03740659|BG002|Baseline|Dexamethasone|"Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.~Administration route: ocular instillation~Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP)."
11357941|NCT03740659|BG003|Baseline|Total|Total of all reporting groups
11357942|NCT03740659|FG000|Participant Flow|Levofloxacin + Dexamethasone|"Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.~Administration route: ocular instillation~Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP)."
11357943|NCT03740659|FG001|Participant Flow|Levofloxacin|"Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.~Administration route: ocular instillation~Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin)."
11357944|NCT03740659|FG002|Participant Flow|Dexamethasone|"Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.~Administration route: ocular instillation~Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP)."
11357945|NCT03740659|OG000|Outcome|Levofloxacin + Dexamethasone|"Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.~Administration route: ocular instillation~Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP)."
11357946|NCT03740659|OG001|Outcome|Levofloxacin|"Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.~Administration route: ocular instillation~Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin)."
11357947|NCT03740659|OG002|Outcome|Dexamethasone|"Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.~Administration route: ocular instillation~Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP)."
11357948|NCT03740659|EG000|Reported Event|Levofloxacin + Dexamethasone|"Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.~Administration route: ocular instillation~Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP)."
11357949|NCT03740659|EG001|Reported Event|Levofloxacin|"Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.~Administration route: ocular instillation~Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin)."
11357950|NCT03740659|EG002|Reported Event|Dexamethasone|"Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.~Administration route: ocular instillation~Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP)."
11357951|NCT03740152|BG000|Baseline|Transcranial Light Therapy|"All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT.~Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)"
11357952|NCT03740152|FG000|Participant Flow|Transcranial Light Therapy|"All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT.~Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)"
11357953|NCT03740152|OG000|Outcome|Transcranial Light Therapy|"All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT.~Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)"
11357954|NCT03740152|EG000|Reported Event|Transcranial Light Therapy Recipients|All participants
11357955|NCT03739866|BG000|Baseline|Part A: Lenacapavir 20 mg|Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357956|NCT03739866|BG001|Baseline|Part A: Lenacapavir 50 mg|Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357957|NCT03739866|BG002|Baseline|Part A: Lenacapavir 150 mg|Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357958|NCT03739866|BG003|Baseline|Part A: Lenacapavir 450 mg|Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357959|NCT03739866|BG004|Baseline|Part A: Lenacapavir 750 mg|Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357960|NCT03739866|BG005|Baseline|Part A: Placebo|Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357961|NCT03739866|BG006|Baseline|Part B: TAF 200 mg|Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357962|NCT03739866|BG007|Baseline|Part B: TAF 600 mg|Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy on started on Day 10 through Day 225.
11357963|NCT03739866|BG008|Baseline|Total|Total of all reporting groups
11357964|NCT03739866|FG000|Participant Flow|Part A: Lenacapavir 20 mg|Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as per standard-care therapy started on Day 10 through Day 225.
11357965|NCT03739866|FG001|Participant Flow|Part A: Lenacapavir 50 mg|Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357966|NCT03739866|FG002|Participant Flow|Part A: Lenacapavir 150 mg|Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357967|NCT03739866|FG003|Participant Flow|Part A: Lenacapavir 450 mg|Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357968|NCT03739866|FG004|Participant Flow|Part A: Lenacapavir 750 mg|Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357969|NCT03739866|FG005|Participant Flow|Part A: Placebo|Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357970|NCT03739866|FG006|Participant Flow|Part B: Tenofovir Alafenamide (TAF) 200 mg|Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357971|NCT03739866|FG007|Participant Flow|Part B: TAF 600 mg|Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357972|NCT03739866|OG000|Outcome|Part A: Lenacapavir 20 mg|Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357973|NCT03739866|OG001|Outcome|Part A: Lenacapavir 50 mg|Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11236673|NCT02450747|OG000|Outcome|Basline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
11236674|NCT02450747|OG001|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
11236675|NCT02450747|OG001|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
11236676|NCT02450747|EG000|Reported Event|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
11236677|NCT02450799|BG000|Baseline|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
11236678|NCT02450799|BG001|Baseline|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
11236679|NCT02450799|BG002|Baseline|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
11236680|NCT02450799|BG003|Baseline|Total|Total of all reporting groups
11236681|NCT02450799|FG000|Participant Flow|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
11236682|NCT02450799|FG001|Participant Flow|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
11236683|NCT02450799|FG002|Participant Flow|PMMA|Polymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes
11236684|NCT02450799|OG000|Outcome|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
11236685|NCT02450799|OG001|Outcome|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
11236686|NCT02450799|OG002|Outcome|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
11236687|NCT02450799|EG000|Reported Event|AcrySof (Retrospective)|Subjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eye
11236688|NCT02450799|EG001|Reported Event|Silicone (Retrospective)|Subjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eye
11236689|NCT02450799|EG002|Reported Event|PMMA (Retrospective)|Subjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eye
11236690|NCT02450799|EG003|Reported Event|AcrySof (Prospective)|Subjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisition
11236691|NCT02450799|EG004|Reported Event|Silicone (Prospective)|Subjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisition
11236692|NCT02450799|EG005|Reported Event|PMMA (Prospective)|Subjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition
11236693|NCT02450903|BG000|Baseline|LDK378 (Ceritinib)|Participants who received LDK378 750mg once daily on a 28 day cycle.
11236694|NCT02450903|FG000|Participant Flow|LDK378 (Ceritinib)|Participants who received LDK378 750mg once daily on a 28 day cycle.
11236695|NCT02450903|OG000|Outcome|LDK378 (Ceritinib)|Participants who received LDK378 750mg once daily on a 28 day cycle.
11236696|NCT02450903|EG000|Reported Event|LDK378 (Ceritinib)|Participants who received LDK378 750mg once daily on a 28 day cycle.
11236697|NCT02451007|BG000|Baseline|Group A - Lurbinectedin (PM01183)|"lurbinectedin (PM01183) is presented as a lyophilized powder for concentrate for solution for infusion with strength of 4 mg / vial.~Lurbinectedin was administered at a dose of 3.2 mg/m² given as a 1-hour i.v. every three weeks (q3wk) (three weeks = one treatment cycle). QTc interval duration was assessed when the patient was treated with lurbinectedin for the first time."
11236698|NCT02451007|FG000|Participant Flow|Group A - Lurbinectedin (PM01183)|"lurbinectedin (PM01183) is presented as a lyophilized powder for concentrate for solution for infusion with strength of 4 mg / vial.~Lurbinectedin was administered at a dose of 3.2 mg/m² given as a 1-hour i.v. every three weeks (q3wk) (three weeks = one treatment cycle). QTc interval duration was assessed when the patient was treated with lurbinectedin for the first time."
11236699|NCT02451007|OG000|Outcome|Group A - Lurbinectedin (PM01183)|"lurbinectedin (PM01183) is presented as a lyophilized powder for concentrate for solution for infusion with strength of 4 mg / vial.~Lurbinectedin was administered at a dose of 3.2 mg/m² given as a 1-hour i.v. every three weeks (q3wk) (three weeks = one treatment cycle). QTc interval duration was assessed when the patient was treated with lurbinectedin for the first time."
11236700|NCT02451007|EG000|Reported Event|Group A - Lurbinectedin (PM01183)|"lurbinectedin (PM01183) is presented as a lyophilized powder for concentrate for solution for infusion with strength of 4 mg / vial.~Lurbinectedin was administered at a dose of 3.2 mg/m² given as a 1-hour i.v. every three weeks (q3wk) (three weeks = one treatment cycle)."
11236701|NCT02451124|BG000|Baseline|Screening: Non-endoscopic Inflatable Balloon for the Esophagus|"Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.~non-endoscopic inflatable balloon for the esophagus: Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing"
11236702|NCT02451124|FG000|Participant Flow|Screening: Non-endoscopic Inflatable Balloon for the Esophagus|"Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.~non-endoscopic inflatable balloon for the esophagus: Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing"
11236703|NCT02451124|OG000|Outcome|Low Discomfort|scores of 1-2 (low discomfort)
11236704|NCT02451124|OG001|Outcome|Intermediate Discomfort|Scores of 3-8 (intermediate discomfort)
11236705|NCT02451124|OG002|Outcome|High Discomfort|Scores of 9-10 (high discomfort)
11236706|NCT02451124|OG000|Outcome|Screening: Non-endoscopic Inflatable Balloon for the Esophagus|"Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 3-15 minutes followed by a standard EGD. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~EGD: Standard of care, patients' digestive tract examined with EGD post balloon brushing"
11236707|NCT02451124|OG000|Outcome|Screening: Non-endoscopic Inflatable Balloon for the Esophagus|"Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.~non-endoscopic inflatable balloon for the esophagus: Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing"
11236708|NCT02451124|EG000|Reported Event|Screening: Non-endoscopic Inflatable Balloon for the Esophagus|"Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 3-15 minutes followed by a standard EGD. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~EGD: Standard of care, patients' digestive tract examined with EGD post balloon brushing"
11236709|NCT02451137|BG000|Baseline|Toujeo|Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program.
11236710|NCT02451137|BG001|Baseline|Standard of Care|Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
11236711|NCT02451137|BG002|Baseline|Total|Total of all reporting groups
11236712|NCT02451137|FG000|Participant Flow|Toujeo|Toujeo® (Insulin glargine, 300 units per millilitre [U/mL]) subcutaneous (SC) injection administered once daily up to Month 12, with or without available participant support program.
11236713|NCT02451137|FG001|Participant Flow|Standard of Care|Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
11236714|NCT02451137|OG000|Outcome|Toujeo|Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program.
11236715|NCT02451137|OG001|Outcome|Standard of Care|Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
11236716|NCT02451137|EG000|Reported Event|Toujeo|Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program.
11236717|NCT02451137|EG001|Reported Event|Standard of Care Basal Insulin|Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
11236718|NCT02451150|BG000|Baseline|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
11236719|NCT02451150|BG001|Baseline|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
11236720|NCT02451150|BG002|Baseline|Total|Total of all reporting groups
11236721|NCT02451150|FG000|Participant Flow|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
11236722|NCT02451150|FG001|Participant Flow|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
11236723|NCT02451150|OG000|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
11236724|NCT02451150|OG001|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
11236725|NCT02451150|EG000|Reported Event|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
11236726|NCT02451150|EG001|Reported Event|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
11236727|NCT02451202|BG000|Baseline|Deep Neuromuscular Blockade Arm|"After initial doses of 0.6 mg Rocuronium, a continuous infusion can be initiated to maintain 0 responses to train-of-four (TOF) stimulation or 1-2 responses to Post-Tetanic Count (PTC) (Deep NMB). The pump rate will vary and depends on the PTC value. The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required PTC value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthetist. Deep NMB should be maintained throughout the operation.~The infusion of Rocuronium will be discontinued and Sugammadex will be given 4 mg/kg at the end of surgery, which is from deep NMB (PTC = 1-2)."
11236728|NCT02451202|BG001|Baseline|Moderate Neuromuscular Blockade Arm|"After evidence of early spontaneous recovery (< 10% of control T1) from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain 1 to 2 responses to train-of-four stimulation (Moderate NMB). The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required TOF value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthesiologist. Moderate paralysis should be maintained throughout an operation.~At the end of surgery, the infusion of Rocuronium will be discontinued and Sugammadex 2 mg/kg via bolus injections]will be administered at least reappearance of T2."
11236729|NCT02451202|BG002|Baseline|Total|Total of all reporting groups
11236730|NCT02451202|FG000|Participant Flow|Deep Neuromuscular Blockade Arm|"After initial doses of 0.6 mg Rocuronium, a continuous infusion can be initiated to maintain 0 responses to train-of-four (TOF) stimulation or 1-2 responses to Post-Tetanic Count (PTC) (Deep NMB). The pump rate will vary and depends on the PTC value. The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required PTC value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthetist. Deep NMB should be maintained throughout the operation.~The infusion of Rocuronium will be discontinued and Sugammadex will be given 4 mg/kg at the end of surgery, which is from deep NMB (PTC = 1-2).~Deep Neuromuscular Blockade: - During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).~- At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by"
11236731|NCT02451202|FG001|Participant Flow|Moderate Neuromuscular Blockade Arm|"After evidence of early spontaneous recovery (< 10% of control T1) from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain 1 to 2 responses to train-of-four stimulation (Moderate NMB). The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required TOF value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthesiologist. Moderate paralysis should be maintained throughout an operation.~At the end of surgery, the infusion of Rocuronium will be discontinued and Sugammadex 2 mg/kg via bolus injections]will be administered at least reappearance of T2.~Moderate Neuromuscular Blockade: - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.~Sugammadex~Rocuronium"
11236732|NCT02451202|OG000|Outcome|Moderate Neuromuscular Blockade Arm|Moderate Neuromuscular Blockade: - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.
11236733|NCT02451202|OG001|Outcome|Deep Neuromuscular Blockade Arm|"Deep Neuromuscular Blockade: - During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).~- At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2."
11236734|NCT02451202|OG000|Outcome|Deep Neuromuscular Blockade Arm|"Deep Neuromuscular Blockade: - During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).~- At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2."
11236735|NCT02451202|OG001|Outcome|Moderate Neuromuscular Blockade Arm|Moderate Neuromuscular Blockade: - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.
11236736|NCT02451202|EG000|Reported Event|Deep Neuromuscular Blockade Arm|"Deep Neuromuscular Blockade: - During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).~- At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2."
11236737|NCT02451202|EG001|Reported Event|Moderate Neuromuscular Blockade Arm|Moderate Neuromuscular Blockade: - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.
11236738|NCT02451488|BG000|Baseline|GM-CSF|"Patients will be treated with 14 days of GM-CSF self-administered subcutaneously daily for 14 days in a dose of 125 µg/m2 beginning on the day of enrollment. Patients will be instructed in the self-administration of GM-CSF and after they have demonstrated competency with the procedure, they will self-administer the treatment at home. Patients will undergo surgery within 1 day to 5 days after cessation of the GM-CSF therapy.~GM-CSF: 14 days in a dose of 125 µg/m^2"
11236739|NCT02451488|BG001|Baseline|Standard of Care|"no neo-adjuvant therapy prior to surgical intervention~Standard of Care: No neo-adjuvant therapy prior to surgical intervention"
11236740|NCT02451488|BG002|Baseline|Total|Total of all reporting groups
11236741|NCT02451488|FG000|Participant Flow|GM-CSF|"Patients will be treated with 14 days of GM-CSF self-administered subcutaneously daily for 14 days in a dose of 125 µg/m2 beginning on the day of enrollment. Patients will be instructed in the self-administration of GM-CSF and after they have demonstrated competency with the procedure, they will self-administer the treatment at home. Patients will undergo surgery within 1 day to 5 days after cessation of the GM-CSF therapy.~GM-CSF: 14 days in a dose of 125 µg/m^2"
11236742|NCT02451488|FG001|Participant Flow|Standard of Care|"no neo-adjuvant therapy prior to surgical intervention~Standard of Care: No neo-adjuvant therapy prior to surgical intervention"
11236743|NCT02451488|OG000|Outcome|GM-CSF|"Patients will be treated with 14 days of GM-CSF self-administered subcutaneously daily for 14 days in a dose of 125 µg/m2 beginning on the day of enrollment. Patients will be instructed in the self-administration of GM-CSF and after they have demonstrated competency with the procedure, they will self-administer the treatment at home. Patients will undergo surgery within 1 day to 5 days after cessation of the GM-CSF therapy.~GM-CSF: 14 days in a dose of 125 µg/m^2"
11236744|NCT02451488|OG001|Outcome|Standard of Care|no neo-adjuvant therapy prior to surgical intervention Standard of Care: No neo-adjuvant therapy prior to surgical intervention
11341464|NCT03682705|BG001|Baseline|UPA 15 mg/ELS 60 mg|15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
11357974|NCT03739866|OG002|Outcome|Part A: Lenacapavir 150 mg|Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357975|NCT03739866|OG003|Outcome|Part A: Lenacapavir 450 mg|Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357976|NCT03739866|OG004|Outcome|Part A: Lenacapavir 750 mg|Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357977|NCT03739866|OG005|Outcome|Part A: Placebo|Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357978|NCT03739866|OG006|Outcome|Part B: TAF 200 mg|Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357979|NCT03739866|OG007|Outcome|Part B: TAF 600 mg|Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357980|NCT03739866|OG005|Outcome|Part B: TAF 200 mg|Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357981|NCT03739866|OG006|Outcome|Part B: TAF 600 mg|Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357982|NCT03739866|OG000|Outcome|Part B: TAF 200 mg|Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357983|NCT03739866|OG001|Outcome|Part B: TAF 600 mg|Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357984|NCT03739866|EG000|Reported Event|Part A: Lenacapavir 20 mg|Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357985|NCT03739866|EG001|Reported Event|Part A: Lenacapavir 50 mg|Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357986|NCT03739866|EG002|Reported Event|Part A: Lenacapavir 150 mg|Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357987|NCT03739866|EG003|Reported Event|Part A: Lenacapavir 450 mg|Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357988|NCT03739866|EG004|Reported Event|Part A: Lenacapavir 750 mg|Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357989|NCT03739866|EG005|Reported Event|Part A: Placebo|Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357990|NCT03739866|EG006|Reported Event|Part B: TAF 200 mg|Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357991|NCT03739866|EG007|Reported Event|Part B: TAF 600 mg|Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
11357992|NCT03739684|BG000|Baseline|18F-DCFPyL Injection|Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
11357993|NCT03739684|FG000|Participant Flow|18F-DCFPyL Injection|Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
11357994|NCT03739684|OG000|Outcome|18F-DCFPyL Injection|Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
11357995|NCT03739684|EG000|Reported Event|18F-DCFPyL Injection|Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
11357996|NCT03739528|BG000|Baseline|Levofloxacin + Dexamethasone Followed by Dexamethasone|"Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)~Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day."
11357997|NCT03739528|BG001|Baseline|Tobramycin + Dexamethasone|"Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)~Dose and regimen: 1 drop - 4 times a day for 14 days"
11357998|NCT03739528|BG002|Baseline|Total|Total of all reporting groups
11357999|NCT03739528|FG000|Participant Flow|Levofloxacin + Dexamethasone Followed by Dexamethasone|"Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)~Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day."
11358000|NCT03739528|FG001|Participant Flow|Tobramycin + Dexamethasone|"Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)~Dose and regimen: 1 drop - 4 times a day for 14 days"
11236745|NCT02451488|EG000|Reported Event|GM-CSF|"Patients will be treated with 14 days of GM-CSF self-administered subcutaneously daily for 14 days in a dose of 125 µg/m2 beginning on the day of enrollment. Patients will be instructed in the self-administration of GM-CSF and after they have demonstrated competency with the procedure, they will self-administer the treatment at home. Patients will undergo surgery within 1 day to 5 days after cessation of the GM-CSF therapy.~GM-CSF: 14 days in a dose of 125 µg/m^2"
11236746|NCT02451488|EG001|Reported Event|Standard of Care|"no neo-adjuvant therapy prior to surgical intervention~Standard of Care: No neo-adjuvant therapy prior to surgical intervention"
11236747|NCT02451514|BG000|Baseline|MenABCWY+OMV Group|Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.
11236748|NCT02451514|BG001|Baseline|MenACWY Group|Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.
11236749|NCT02451514|BG002|Baseline|Naive Group|Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.
11236750|NCT02451514|BG003|Baseline|Total|Total of all reporting groups
11236751|NCT02451514|FG000|Participant Flow|MenABCWY+OMV Group|Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.
11236752|NCT02451514|FG001|Participant Flow|MenACWY Group|Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.
11236753|NCT02451514|FG002|Participant Flow|Naive Group|Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.
11236754|NCT02451514|OG000|Outcome|MenABCWY+OMV Group|Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.
11236755|NCT02451514|OG001|Outcome|MenACWY Group|Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.
11236756|NCT02451514|OG002|Outcome|Naive Group|Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.
11236757|NCT02451514|OG000|Outcome|MenABCWY+OMV Group (A)|Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 4, Day 8 and Day 31.
11236758|NCT02451514|OG001|Outcome|MenACWY Group (B1)|Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart, in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 4, Day 31 (before vaccination) and Day 61.
11236759|NCT02451514|OG002|Outcome|MenACWY Group (B2)|Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart, in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 8, Day 31 (before vaccination) and Day 61.
11236760|NCT02451514|OG003|Outcome|Naive Group (C1)|Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.
11236761|NCT02451514|OG004|Outcome|Naive Group (C2)|Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
11236762|NCT02451514|OG000|Outcome|Naive Group|Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.
11236763|NCT02451514|OG000|Outcome|MenACWY Group|Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.
11236764|NCT02451514|OG001|Outcome|Naive Group|Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.
11236765|NCT02451514|EG000|Reported Event|MenABCWY+OMV Group|Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.
11236766|NCT02451514|EG001|Reported Event|MenACWY Group|Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.
11236767|NCT02451514|EG002|Reported Event|Naive Group|Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.
11236768|NCT02451670|BG000|Baseline|Prioritized Clinical Decision Support|Patients and their primary care providers were presented with patient-specific written instructions as to prioritized treatment and lifestyle changes that could reduce cardiovascular risk, prompted by an electronic health record-based alert during their primary care visits.
11236769|NCT02451670|BG001|Baseline|Usual Care|Patients and their providers were not presented with the prioritized clinical decision support.
11236770|NCT02451670|BG002|Baseline|Total|Total of all reporting groups
11236771|NCT02451670|FG000|Participant Flow|Prioritized Clinical Support|Patients and their primary care providers in the intervention arm were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record-based alert during their primary care visit.
11236772|NCT02451670|FG001|Participant Flow|Usual Care|Patients and their primary care providers in the usual care arm were not presented with prioritized clinical decision support.
11236773|NCT02451670|OG000|Outcome|Prioritized Clinical Decision Support|Patients and their primary care providers were presented with their patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record based alert during their primary care visits.
11236774|NCT02451670|OG001|Outcome|Usual Care|Patients and providers were not presented with the prioritized clinical decision support.
11236775|NCT02451670|EG000|Reported Event|Prioritized Clinical Decision Support|Patients and providers were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record based alert during their primary care visits.
11236776|NCT02451670|EG001|Reported Event|Usual Care|Patients and providers were not presented with the prioritized clinical decision support.
11236777|NCT02451696|BG000|Baseline|Treated Subjects|"This group will be treated with everolimus 7-28 days prior to surgery~Everolimus: This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not"
11236778|NCT02451696|BG001|Baseline|Reference Subjects|This group will be enrolled as reference subjects, and will be undergoing routine surgery as part of standard of care treatment. No intervention will be provided to these subjects as part of the study.
11236779|NCT02451696|BG002|Baseline|Total|Total of all reporting groups
11236780|NCT02451696|FG000|Participant Flow|Treated Subjects|This group will be treated with everolimus 7-28 days prior to surgery Everolimus: This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not
11236781|NCT02451696|FG001|Participant Flow|Reference Subjects|This group will be enrolled as reference subjects, and will be undergoing routine surgery as part of standard of care treatment. No intervention will be provided to these subjects as part of the study
11236782|NCT02451696|OG000|Outcome|Treated Subjects|"This group will be treated with everolimus 7-28 days prior to surgery~Everolimus: This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not"
11236783|NCT02451696|OG001|Outcome|Reference Subjects|This group will be enrolled as reference subjects, and will be undergoing routine surgery as part of standard of care treatment. No intervention will be provided to these subjects as part of the study.
11236784|NCT02451696|OG000|Outcome|Treated Subjects|This group will be treated with everolimus 7-28 days prior to surgery Everolimus: This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not
11236785|NCT02451696|OG001|Outcome|Reference Subjects|This group will be enrolled as reference subjects, and will be undergoing routine surgery as part of standard of care treatment. No intervention will be provided to these subjects as part of the study
11236786|NCT02451696|EG000|Reported Event|Treated Subject|"This group will be treated with everolimus 7-28 days prior to surgery~Everolimus: This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not"
11236787|NCT02451696|EG001|Reported Event|Reference Subject|This group will be enrolled as reference subjects, and will be undergoing routine surgery as part of standard of care treatment. No intervention will be provided to these subjects as part of the study.
11236788|NCT02451839|BG000|Baseline|All Indications|Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236789|NCT02451839|FG000|Participant Flow|Crohn's Disease|Participants with Crohn's disease. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236790|NCT02451839|FG001|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236791|NCT02451839|FG002|Participant Flow|Psoriasis|Participants with psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236792|NCT02451839|OG000|Outcome|All Indications|Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236793|NCT02451839|OG000|Outcome|Crohn's Disease|Participants with Crohn's disease. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236794|NCT02451839|OG000|Outcome|Psoriasis|Participants with psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236795|NCT02451839|OG000|Outcome|Rheumatoid Arthritis|"Participants with rheumatoid arthritis. All participants received at least 3 months of treatment with adalimumab.~Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet."
11236796|NCT02451839|OG000|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236797|NCT02451839|EG000|Reported Event|All Indications|Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
11236798|NCT02451917|BG000|Baseline|Glargine Insulin, Then NPH Insulin|The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained
11236799|NCT02451917|BG001|Baseline|NPH Insulin, Then Glargine Insulin|The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.
11236800|NCT02451917|BG002|Baseline|Total|Total of all reporting groups
11236801|NCT02451917|FG000|Participant Flow|Glargine Insulin, Then NPH Insulin|The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained
11236802|NCT02451917|FG001|Participant Flow|NPH Insulin, Then Glargine Insulin|The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.
11236803|NCT02451917|OG000|Outcome|Glargine Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
11236804|NCT02451917|OG001|Outcome|NPH Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
11236805|NCT02451917|OG000|Outcome|Glargine Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as glargine insulin.
11341465|NCT03682705|BG002|Baseline|ELS 60 mg/UPA Placebo|60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11358001|NCT03739528|OG000|Outcome|Levofloxacin + Dexamethasone Followed by Dexamethasone|"Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)~Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day."
11358002|NCT03739528|OG001|Outcome|Tobramycin + Dexamethasone|"Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)~Dose and regimen: 1 drop - 4 times a day for 14 days"
11358003|NCT03739528|OG000|Outcome|Levofloxacin + Dexamethasone Followed by Dexamethasone|"Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)~Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day"
11358004|NCT03739528|OG000|Outcome|Levofloxacin + Dexamethasone Followed by Dexamethasone|"Levofloxacin 5 mg/ml+Dexamethasone 1 mg/ml (7 days,1 drop/4 times a day) followed by dexamethasone 1 mg/ml (7 days,1 drop/4 times a day).~Levofloxacin + dexamethasone followed by dexamethasone: Levofloxacin + dexamethasone ophthalmic solution for 7 days, 1 drop - 4 times a day, followed by dexamethasone ophthalmic suspension (Maxidex®) for an additional 7 days, 1 drop - 4 times a day."
11358005|NCT03739528|OG001|Outcome|Tobramycin + Dexamethasone|"Tobramycin + dexamethasone (14 days, 1 drop/4 times a day).~Tobramycin + Dexamethasone: Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day."
11358006|NCT03739528|EG000|Reported Event|Levofloxacin + Dexamethasone Followed by Dexamethasone|"Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)~Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day."
11358007|NCT03739528|EG001|Reported Event|Tobramycin + Dexamethasone|"Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)~Dose and regimen: 1 drop - 4 times a day for 14 days"
11358008|NCT03739242|BG000|Baseline|Nutraceutical Combination|"One film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol.~Nutraceutical combination: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)"
11358009|NCT03739242|BG001|Baseline|Placebo|"One film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product.~Placebo: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)"
11358010|NCT03739242|BG002|Baseline|Total|Total of all reporting groups
11358011|NCT03739242|FG000|Participant Flow|Nutraceutical Combination|"One film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol.~Nutraceutical combination: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)"
11358012|NCT03739242|FG001|Participant Flow|Placebo|"One film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product.~Placebo: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)"
11358013|NCT03739242|OG000|Outcome|Nutraceutical Combination|"One film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol.~Nutraceutical combination: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)"
11358014|NCT03739242|OG001|Outcome|Placebo|"One film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product.~Placebo: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)"
11358015|NCT03739242|EG000|Reported Event|Nutraceutical Combination|"One film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol.~Nutraceutical combination: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)"
11358016|NCT03739242|EG001|Reported Event|Placebo|"One film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product.~Placebo: One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)"
11358017|NCT03738865|BG000|Baseline|G-Pen, Then Novo Glucagon|Participants first received G-Pen 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received Novo Glucagon 1 mg subcutaneous injection.
11358018|NCT03738865|BG001|Baseline|Novo Glucagon, Then G-Pen|Participants first received Novo Glucagon 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received G-Pen 1 mg subcutaneous injection.
11358019|NCT03738865|BG002|Baseline|Total|Total of all reporting groups
11358020|NCT03738865|FG000|Participant Flow|G-Pen, Then Novo Glucagon|Participants first received G-Pen 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received Novo Glucagon 1 mg subcutaneous injection
10961836|NCT00863122|EG001|Reported Event|Control|Control subjects will not receive any intervention prior to surgery for vestibular schwannoma resection. Control subjects donate tissue at the time of surgery. AEs were not collected in this group as there was no study intervention (i.e. they did not take the drug).
10961837|NCT00863265|BG000|Baseline|All Study Participants|All study participants.
10961838|NCT00863265|FG000|Participant Flow|Crossover Order ABC|"Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.~A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols."
10961839|NCT00863265|FG001|Participant Flow|Crossover Order BCA|"Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.~A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols."
11185149|NCT02093026|BG000|Baseline|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
10961840|NCT00863265|FG002|Participant Flow|Crossover Order BAC|"Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.~A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols."
11185150|NCT02093026|FG000|Participant Flow|Rituximab|Participants received rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (>=) 5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
11185151|NCT02093026|OG000|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
11185152|NCT02093026|EG000|Reported Event|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
11185153|NCT02093026|EG001|Reported Event|Placebo|Data for participants who received placebo in Study WA17043 or WA16291 are included in this reporting group for data collected until they received their first dose of rituximab in this study (Study WA16855). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
11185154|NCT02093221|BG000|Baseline|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
11185155|NCT02093221|BG001|Baseline|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
11185156|NCT02093221|BG002|Baseline|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
11185157|NCT02093221|BG003|Baseline|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
11185158|NCT02093221|BG004|Baseline|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
11185159|NCT02093221|BG005|Baseline|Total|Total of all reporting groups
11185160|NCT02093221|FG000|Participant Flow|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
10961841|NCT00863265|FG003|Participant Flow|Crossover Order ACB|"Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.~A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols."
11185161|NCT02093221|FG001|Participant Flow|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
11185162|NCT02093221|FG002|Participant Flow|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
11185163|NCT02093221|FG003|Participant Flow|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
11185164|NCT02093221|FG004|Participant Flow|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
11185165|NCT02093221|OG000|Outcome|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
11185166|NCT02093221|OG001|Outcome|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
11185167|NCT02093221|OG002|Outcome|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
11185168|NCT02093221|OG003|Outcome|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
11185169|NCT02093221|OG004|Outcome|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
11185170|NCT02093221|EG000|Reported Event|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
11185171|NCT02093221|EG001|Reported Event|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
11185172|NCT02093221|EG002|Reported Event|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
11185173|NCT02093221|EG003|Reported Event|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
11185174|NCT02093221|EG004|Reported Event|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
11185175|NCT02093234|BG000|Baseline|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
11185176|NCT02093234|BG001|Baseline|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
11185177|NCT02093234|BG002|Baseline|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
11185178|NCT02093234|BG003|Baseline|Total|Total of all reporting groups
11185179|NCT02093234|FG000|Participant Flow|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
11185180|NCT02093234|FG001|Participant Flow|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
11185181|NCT02093234|FG002|Participant Flow|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
11185182|NCT02093234|OG000|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
11185183|NCT02093234|OG001|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
11185184|NCT02093234|OG002|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
11185185|NCT02093234|EG000|Reported Event|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
11185186|NCT02093234|EG001|Reported Event|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
11185187|NCT02093234|EG002|Reported Event|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
11185188|NCT02093351|BG000|Baseline|Cohort 1 - Tamoxifen|In Part A, patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11185189|NCT02093351|BG001|Baseline|Cohort 2 - Anastrozole|In Part A, patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11185190|NCT02093351|BG002|Baseline|Cohort 3 - Letrozole|In Part A, patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11185191|NCT02093351|BG003|Baseline|Total|Total of all reporting groups
11185192|NCT02093351|FG000|Participant Flow|Cohort 1 - Tamoxifen|In Part A, patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11185193|NCT02093351|FG001|Participant Flow|Cohort 2 - Anastrozole|In Part A, patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11185194|NCT02093351|FG002|Participant Flow|Cohort 3 - Letrozole|In Part A, patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11358021|NCT03738865|FG001|Participant Flow|Novo Glucagon, Then G-Pen|Participants first received Novo Glucagon 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received G-Pen 1 mg subcutaneous injection
11358022|NCT03738865|OG000|Outcome|G-Pen|Participants received G-Pen 1 mg subcutaneous injection each.
11358023|NCT03738865|OG001|Outcome|Novo Glucagon|Participants received Novo Glucagon 1 mg subcutaneous injection each.
11358024|NCT03738865|EG000|Reported Event|G-Pen|G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
11358025|NCT03738865|EG001|Reported Event|Novo Glucagon|Novo Glucagon: 1 mg subcutaneous injection of Novo Glucagon (glucagon injection)
11358026|NCT03738826|BG000|Baseline|Behavioral Intervention|"Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.~Behavioral Intervention: Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter."
11358027|NCT03738826|BG001|Baseline|Lupus Clinic Providers|Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
11358028|NCT03738826|BG002|Baseline|Total|Total of all reporting groups
11185195|NCT02093351|FG003|Participant Flow|Olaparib (Part B)|In Part B, patients continued to receive olaparib 300 mg bd either as monotherapy or in combination with routine clinical regimes of letrozole, anastrazole or tamoxifen if deemed necessary by the investigator.
11185196|NCT02093351|OG000|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
11358029|NCT03738826|FG000|Participant Flow|Behavioral Intervention|"Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.~Behavioral Intervention: Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter."
11358030|NCT03738826|FG001|Participant Flow|Lupus Clinic Providers|Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
11358031|NCT03738826|OG000|Outcome|Behavioral Intervention|"Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.~Behavioral Intervention: Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter."
11358032|NCT03738826|OG001|Outcome|Lupus Clinic Providers|Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
11358033|NCT03738826|EG000|Reported Event|Behavioral Intervention|"Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.~Behavioral Intervention: Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter."
11358034|NCT03738826|EG001|Reported Event|Lupus Clinic Providers|Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
11358035|NCT03738475|BG000|Baseline|TIMP-GLIA 8 mg/kg|TIMP-GLIA 8 mg/kg, infusion, intravenously, once on Days 1 and 8.
11358036|NCT03738475|BG001|Baseline|Placebo|TIMP-GLIA placebo-matching infusion, intravenously, once on Days 1 and 8.
11358037|NCT03738475|BG002|Baseline|Total|Total of all reporting groups
11185197|NCT02093351|OG001|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
11358038|NCT03738475|FG000|Participant Flow|TIMP-GLIA 8 mg/kg|TIMP-GLIA 8 milligram per kilogram (mg/kg), infusion, intravenously, once on Days 1 and 8.
11358039|NCT03738475|FG001|Participant Flow|Placebo|TIMP-GLIA placebo-matching infusion, intravenously, once on Days 1 and 8.
11358040|NCT03738475|OG000|Outcome|TIMP-GLIA 8 mg/kg|TIMP-GLIA 8 mg/kg, infusion, intravenously, once on Days 1 and 8.
11358041|NCT03738475|OG001|Outcome|Placebo|TIMP-GLIA placebo-matching infusion, intravenously, once on Days 1 and 8.
11358042|NCT03738475|EG000|Reported Event|TIMP-GLIA 8 mg/kg|TIMP-GLIA 8 mg/kg, infusion, intravenously, once on Days 1 and 8.
11358043|NCT03738475|EG001|Reported Event|Placebo|TIMP-GLIA placebo-matching infusion, intravenously, once on Days 1 and 8.
11358044|NCT03738241|BG000|Baseline|"2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV"|2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358045|NCT03738241|BG001|Baseline|"2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358046|NCT03738241|BG002|Baseline|"2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV"|2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11185198|NCT02093351|OG000|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
11185199|NCT02093351|OG000|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
11185200|NCT02093351|OG001|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
11185201|NCT02093351|OG000|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
11185202|NCT02093351|OG000|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
11185203|NCT02093351|OG001|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
11185204|NCT02093351|OG000|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
11185205|NCT02093351|EG000|Reported Event|Cohort 1 - Tamoxifen|In Part A, patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11185206|NCT02093351|EG001|Reported Event|Cohort 2 - Anastrozole|In Part A, patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11185207|NCT02093351|EG002|Reported Event|Cohort 3 - Letrozole|In Part A, patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
11185208|NCT02093351|EG003|Reported Event|Olaparib (Part B)|In Part B, patients continued to receive olaparib 300 mg bd either as monotherapy or in combination with routine clinical regimes of letrozole, anastrazole or tamoxifen if deemed necessary by the investigator.
11185209|NCT02093390|BG000|Baseline|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
11185210|NCT02093390|BG001|Baseline|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
11185211|NCT02093390|BG002|Baseline|Total|Total of all reporting groups
11185212|NCT02093390|FG000|Participant Flow|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
11185213|NCT02093390|FG001|Participant Flow|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
11185214|NCT02093390|OG000|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
11185215|NCT02093390|OG001|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
11185216|NCT02093390|OG000|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
11185217|NCT02093390|EG000|Reported Event|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
11185218|NCT02093390|EG001|Reported Event|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
11185219|NCT02093520|BG000|Baseline|MILD|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
11185220|NCT02093520|BG001|Baseline|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
11185221|NCT02093520|BG002|Baseline|Total|Total of all reporting groups
11341466|NCT03682705|BG003|Baseline|ELS 20 mg/UPA Placebo|20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11185222|NCT02093520|FG000|Participant Flow|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
11185223|NCT02093520|FG001|Participant Flow|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
11185224|NCT02093520|OG000|Outcome|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
11185225|NCT02093520|OG001|Outcome|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
11185226|NCT02093520|EG000|Reported Event|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
11185227|NCT02093520|EG001|Reported Event|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
11191659|NCT02132910|OG000|Outcome|Control Group 2|"First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use.~You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level.~At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.~At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health."
11191660|NCT02132910|OG001|Outcome|RESTORE Intervention|"First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use.~For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor.~For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor.~At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.~At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.~RESTORE Intervention"
11191661|NCT02132910|EG000|Reported Event|RESTORE Intervention|"First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use.~For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor.~For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor.~At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.~At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.~RESTORE Intervention"
11191662|NCT02132910|EG001|Reported Event|Control Group 2|"First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use.~You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level.~At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.~At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health."
11191663|NCT02132936|BG000|Baseline|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
11191664|NCT02132936|BG001|Baseline|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
11191665|NCT02132936|BG002|Baseline|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
11191666|NCT02132936|BG003|Baseline|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks~Gel vehicle"
11191667|NCT02132936|BG004|Baseline|Total|Total of all reporting groups
11191668|NCT02132936|FG000|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
11191669|NCT02132936|FG001|Participant Flow|Aerosol Foam Vehicle|Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
11191670|NCT02132936|FG002|Participant Flow|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
11185228|NCT02093663|BG000|Baseline|Overall Study|Participants with partial UC-DAI > or =2 and mucosal appearance = 2 or 3 entered the DBA phase; with UC-DAI between 1 and 2 entered the OLA phase, after completing DBA phase; with UC-DAI < or = 1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants who had a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBA and DBM phase, participants received 900 to 2400 mg/day (low dose) and 1800 to 4800 mg/day (high dose) of MMX mesalamine/mesalazine tablet orally once daily for 8 and 26 weeks respectively. During OLA phase, participants received the high dose for 8 weeks.
11185229|NCT02093663|FG000|Participant Flow|Double-Blind Acute (DBA) Phase: Low Dose|Participants with partial UC-DAI > or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to < or =23 kg, >23 to < or =35 kg, > 35 to < or =50 kg, > 50 to < or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
11185230|NCT02093663|FG001|Participant Flow|Double-Blind Acute (DBA) Phase: High Dose|Participants with partial UC-DAI > or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to < or =23 kg, > 23 to < or =35 kg, > 35 to < or =50 kg, > 50 to < or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
11185231|NCT02093663|FG002|Participant Flow|Open-Label Acute Phase (OLA): High Dose|During the OLA High dose phase participants weighing 18 to <=23 kg, > 23 to < or =35 kg, >35 to < or = 50 kg, > 50 to < or = 90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
11185232|NCT02093663|FG003|Participant Flow|Double-Blind Maintenance (DBM) Phase: Low Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to < or =23 kg, > 23 to < or =35 kg, > 35 to < or =50 kg, > 50 to < or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185233|NCT02093663|FG004|Participant Flow|Double-Blind Maintenance (DBM) Phase: High Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to <=23 kg, > 23 to < or =35 kg, >35 to < or = 50 kg, > 50 to < or = 90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185234|NCT02093663|OG000|Outcome|Double-Blind Acute (DBA) Phase: Low Dose|Participants with partial UC-DAI > or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to < or =23 kg, >23 to < or =35 kg, > 35 to < or =50 kg, > 50 to < or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
11185235|NCT02093663|OG001|Outcome|Double-Blind Acute (DBA) Phase: High Dose|Participants with partial UC-DAI > or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to < or =23 kg, > 23 to < or =35 kg, > 35 to < or =50 kg, > 50 to < or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
11185236|NCT02093663|OG000|Outcome|Double-Blind Maintenance (DBM) Phase: Low Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to <=23 kg, >23 to <=35 kg, >35 to < or =50 kg, >50 to < or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185237|NCT02093663|OG001|Outcome|Double-Blind Maintenance (DBM) Phase: High Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to <=23 kg, >23 to <=35 kg, >35 to < or =50 kg, >50 to < or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185238|NCT02093663|OG000|Outcome|Double-Blind Acute (DBA) Phase: Low Dose|Participants with partial UC-DAI > or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to < or =23 kg, > 23 to < or =35 kg, > 35 to < or =50 kg, > 50 to < or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
11185239|NCT02093663|OG000|Outcome|Double-Blind Maintenance (DBM) Phase: Low Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to < or =23 kg, > 23 to < or =35 kg, > 35 to < or =50 kg, > 50 to < or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185240|NCT02093663|OG001|Outcome|Double-Blind Maintenance (DBM) Phase: High Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to <=23 kg, > 23 to < or =35 kg, >35 to < or = 50 kg, > 50 to < or = 90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185241|NCT02093663|OG001|Outcome|Double-Blind Maintenance (DBM) Phase: High Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to < or =23 kg, > 23 to < or =35 kg, > 35 to < or =50 kg, > 50 to < or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11191671|NCT02132936|FG003|Participant Flow|Gel Vehicle|Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
11185242|NCT02093663|OG000|Outcome|Double-Blind Maintenance (DBM) Phase: Low Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to <=23 kg, >23 to <=35 kg, >35 to < or =50 kg, > 50 to < or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185243|NCT02093663|OG001|Outcome|Double-Blind Maintenance (DBM) Phase: High Dose|Participants with partial UC-DAI < or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI < or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to <=23 kg, >23 to <=35 kg, >35 to < or =50 kg, > 50 to < or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185244|NCT02093663|EG000|Reported Event|Double-Blind Acute (DBA) Phase: Low Dose|Participants with partial UC-DAI >=2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to <=23 kg, >23 to <=35 kg, >35 to <=50 kg, >50 to <=90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
11358047|NCT03738241|BG003|Baseline|"2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358048|NCT03738241|BG004|Baseline|"2013 A/H7N9 IIV|2017 A/H7N9 IIV"|2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358049|NCT03738241|BG005|Baseline|"2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358050|NCT03738241|BG006|Baseline|"2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV"|2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358051|NCT03738241|BG007|Baseline|"2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11185245|NCT02093663|EG001|Reported Event|Double-Blind Acute (DBA) Phase: High Dose|Participants with partial UC-DAI >=2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to <=23 kg, >23 to <=35 kg, >35 to <=50 kg, >50 to <=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
11358052|NCT03738241|BG008|Baseline|"A/H7 IIV Naïve |2017 A/H7N9 IIV"|3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358053|NCT03738241|BG009|Baseline|"A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03"|3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358054|NCT03738241|BG010|Baseline|Total|Total of all reporting groups
11358055|NCT03738241|FG000|Participant Flow|"2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV"|"Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11185246|NCT02093663|EG002|Reported Event|Open-Label Acute (OLA) Phase: High Dose|Participants with partial UC-DAI between 1 and 2 entered the OLA phase, after completing DBA phase. Participants weighing 18 to <=23 kg, >23 to <=35 kg, >35 to <=50 kg, >50 to <=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively during the high dose OLA phase.
11185247|NCT02093663|EG003|Reported Event|Double-Blind Maintenance (DBM) Phase: Low Dose|Participants with partial UC-DAI <=1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI <=1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to <=23 kg, >23 to <=35 kg, >35 to <=50 kg, >50 to <=90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11191672|NCT02132936|OG000|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
11191673|NCT02132936|OG001|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
11358056|NCT03738241|FG001|Participant Flow|"2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03"|"Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11358057|NCT03738241|FG002|Participant Flow|"2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV"|"Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11358058|NCT03738241|FG003|Participant Flow|"2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03"|"Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11358059|NCT03738241|FG004|Participant Flow|"2013 A/H7N9 IIV|2017 A/H7N9 IIV"|"Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11358060|NCT03738241|FG005|Participant Flow|"2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03"|"Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11358061|NCT03738241|FG006|Participant Flow|"2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV"|"Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11376192|NCT01371981|EG003|Reported Event|Arm C (Cohort 2)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I & concurrently with chemo).~IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36.~INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28.~INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2.~Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year."
11185248|NCT02093663|EG004|Reported Event|Double-Blind Maintenance (DBM) Phase: High Dose|Participants with partial UC-DAI <=1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI <=1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to <=3 kg, >23 to <=35 kg, >35 to <=50 kg, >50 to <=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
11185249|NCT02093702|BG000|Baseline|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
11185250|NCT02093702|BG001|Baseline|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
11185251|NCT02093702|BG002|Baseline|Total|Total of all reporting groups
11185252|NCT02093702|FG000|Participant Flow|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
11185253|NCT02093702|FG001|Participant Flow|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
11185254|NCT02093702|OG000|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
11185255|NCT02093702|OG001|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
11185256|NCT02093702|OG001|Outcome|Structured PA Education Program for People With T2DM|"Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.~."
11185257|NCT02093702|EG000|Reported Event|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
11185258|NCT02093702|EG001|Reported Event|Standard PA Education for People With T2DM (From a CDE)|Group of subjects receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
11185259|NCT02093793|BG000|Baseline|High Rate SCS Followed by Commercial SCS|High Rate SCS Settings followed by Commercial Settings
11185260|NCT02093793|BG001|Baseline|Commercial SCS Settings Followed by High Rate SCS|Commercial SCS Settings followed by High Rate SCS programming settings
11185261|NCT02093793|BG002|Baseline|High Rate Settings Only|High Rate settings only
11185262|NCT02093793|BG003|Baseline|Total|Total of all reporting groups
11185263|NCT02093793|FG000|Participant Flow|High Rate SCS Followed by Commercial SCS|High Rate SCS Settings followed by Commercial Settings
11185264|NCT02093793|FG001|Participant Flow|Commercial SCS Settings Followed by High Rate SCS|Commercial SCS Settings followed by High Rate SCS programming settings
11185265|NCT02093793|FG002|Participant Flow|High Rate Settings Only|High Rate settings only
11185266|NCT02093793|OG000|Outcome|Commercial SCS|Commercial SCS (as part of crossover)
11185267|NCT02093793|OG001|Outcome|High Rate SCS|High Rate SCS (as part of crossover)
11185268|NCT02093793|OG002|Outcome|High Rate Settings Only|High Rate settings only
11185269|NCT02093793|EG000|Reported Event|High Rate SCS|High Rate SCS Settings
11185270|NCT02093793|EG001|Reported Event|Commercial SCS|Commercial SCS Settings
11185271|NCT02093793|EG002|Reported Event|High Rate Settings Only|High Rate settings only
11185272|NCT02093819|BG000|Baseline|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185273|NCT02093819|BG001|Baseline|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185274|NCT02093819|BG002|Baseline|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185275|NCT02093819|BG003|Baseline|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185276|NCT02093819|BG004|Baseline|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185277|NCT02093819|BG005|Baseline|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185278|NCT02093819|BG006|Baseline|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185279|NCT02093819|BG007|Baseline|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185280|NCT02093819|BG008|Baseline|Total|Total of all reporting groups
11185281|NCT02093819|FG000|Participant Flow|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185282|NCT02093819|FG001|Participant Flow|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185283|NCT02093819|FG002|Participant Flow|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185284|NCT02093819|FG003|Participant Flow|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185285|NCT02093819|FG004|Participant Flow|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11341467|NCT03682705|BG004|Baseline|ELS 5 mg/UPA Placebo|5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341468|NCT03682705|BG005|Baseline|UPA 15 mg/ELS Placebo|15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
11341469|NCT03682705|BG006|Baseline|Total|Total of all reporting groups
11341470|NCT03682705|FG000|Participant Flow|ELS Placebo/UPA Placebo|Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341471|NCT03682705|FG001|Participant Flow|UPA 15 mg/ELS 60 mg|15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
11341472|NCT03682705|FG002|Participant Flow|ELS 60 mg/UPA Placebo|60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341473|NCT03682705|FG003|Participant Flow|ELS 20 mg/UPA Placebo|20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341474|NCT03682705|FG004|Participant Flow|ELS 5 mg/UPA Placebo|5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341475|NCT03682705|FG005|Participant Flow|UPA 15 mg/ELS Placebo|15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
11341476|NCT03682705|OG000|Outcome|ELS Placebo/UPA Placebo|Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341477|NCT03682705|OG001|Outcome|UPA 15 mg/ELS 60 mg|15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
11341478|NCT03682705|OG002|Outcome|ELS 60 mg/UPA Placebo|60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341479|NCT03682705|OG003|Outcome|ELS 20 mg/UPA Placebo|20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341480|NCT03682705|OG004|Outcome|ELS 5 mg/UPA Placebo|5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341481|NCT03682705|OG005|Outcome|UPA 15 mg/ELS Placebo|15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
11341482|NCT03682705|EG000|Reported Event|ELS Placebo/UPA Placebo|Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341483|NCT03682705|EG001|Reported Event|UPA 15 mg/ELS 60 mg|15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
11341484|NCT03682705|EG002|Reported Event|ELS 60 mg/UPA Placebo|60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341485|NCT03682705|EG003|Reported Event|ELS 20 mg/UPA Placebo|20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341486|NCT03682705|EG004|Reported Event|ELS 5 mg/UPA Placebo|5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
11341487|NCT03682705|EG005|Reported Event|UPA 15 mg/ELS Placebo|15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
11341488|NCT03682809|BG000|Baseline|Systane Complete|"Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.~Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye."
11341489|NCT03682809|BG001|Baseline|No Treatment|Subjects randomized to this group will not receive a treatment.
11341490|NCT03682809|BG002|Baseline|Total|Total of all reporting groups
11341491|NCT03682809|FG000|Participant Flow|Systane Complete|"Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.~Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye."
11341492|NCT03682809|FG001|Participant Flow|No Treatment|Subjects randomized to this group will not receive a treatment.
11341493|NCT03682809|OG000|Outcome|Systane Complete|"Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.~Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye."
11341494|NCT03682809|OG001|Outcome|No Treatment|Subjects randomized to this group will not receive a treatment.
11341495|NCT03682809|EG000|Reported Event|Systane Complete|"Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.~Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye."
11341496|NCT03682809|EG001|Reported Event|No Treatment|Subjects randomized to this group will not receive a treatment.
11341801|NCT03688620|OG000|Outcome|Vaccinated_AlphaRix Tetra Group|Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
11341802|NCT03688620|OG001|Outcome|Vaccinated_Influsplit Tetra Group|Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
11236806|NCT02451917|OG000|Outcome|Glargine Insulin|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
11236807|NCT02451917|OG001|Outcome|NPH Insulin|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
11236808|NCT02451917|EG000|Reported Event|Glargine Insulin|"This is an open-label, randomized, two-way crossover study , one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine.~Glargine insulin: The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained"
11236809|NCT02451917|EG001|Reported Event|NPH Insulin|"This is an open-label, randomized, two-way crossover study , one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin.~At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH.~NPH insulin: The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained."
11236810|NCT02451930|BG000|Baseline|Part A Cohort 1: 600 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab (pembro) absolute dose by intravenous (IV) infusion on Day1 of 21 days cycles followed by 600 mg necitumumab (Neci) absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC (all histologies).
11236811|NCT02451930|BG001|Baseline|Part A Cohort 2 and Part B: 800 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC of squamous and nonsquamous histology.
11236812|NCT02451930|BG002|Baseline|Part C: 800 mg Neci + 200 mg Pembro|"Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC of squamous and nonsquamous histology.~Part C were Japan participants."
11236813|NCT02451930|BG003|Baseline|Total|Total of all reporting groups
11236814|NCT02451930|FG000|Participant Flow|Part A Cohort 1: 600 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab (pembro) absolute dose by intravenous (IV) infusion on Day1 of 21 days cycles followed by 600 mg necitumumab (Neci) absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC (all histologies).
11236815|NCT02451930|FG001|Participant Flow|Part A Cohort 2, Part B and Part C: 800mg Neci + 200mg Pembro|"Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part A cohort 2 participants with any histology, Part B and C participants with Stage IV NSCLC of squamous and nonsquamous histology.~Part C were Japan participants."
11236816|NCT02451930|OG000|Outcome|Part A Cohort 1: 600 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab (pembro) absolute dose by intravenous (IV) infusion on Day1 of 21 days cycles followed by 600 mg necitumumab (Neci) absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC (all histologies).
11236817|NCT02451930|OG001|Outcome|Part A Cohort 2: 800 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC (all histologies).
11236818|NCT02451930|OG002|Outcome|Part C: 800 mg Neci + 200 mg Pembro|"Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC of squamous and nonsquamous histology.~Part C were Japan participants."
11236819|NCT02451930|OG001|Outcome|Part A Cohort 2, Part B: 800 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part B participants with Stage IV NSCLC of squamous and nonsquamous histology and Part A cohort 2 participants with all histologies.
11236820|NCT02451930|OG000|Outcome|Part A Cohort 2, Part B and Part C: 800 mg Neci + 200mg Pembro|"Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part A cohort 2 participants with any histology, Part B and C participants with Stage IV NSCLC of squamous and nonsquamous histology.~Part C were Japan participants."
11236821|NCT02451930|OG002|Outcome|Part B: 800mg Neci + 200mg Pembro|Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC of squamous and nonsquamous histology.
11236822|NCT02451930|OG003|Outcome|Part C: 800mg Neci + 200mg Pembro|"Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC of squamous and nonsquamous histology.~Part C were Japanese participants."
11236823|NCT02451930|OG000|Outcome|Part A Cohort 1: 600mg Neci + 200mg Pembro|Participants received 200 mg pembrolizumab (pembro) absolute dose by intravenous (IV) infusion on Day1 of 21 days cycles followed by 600 mg necitumumab (Neci) absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC (all histologies).
11236824|NCT02451930|OG001|Outcome|Part A Cohort 2 and Part B: 800 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part B participants with Stage IV NSCLC of squamous and nonsquamous histology and Part A cohort 2 participants with all histologies.
11236825|NCT02451930|OG002|Outcome|Part C: 800 mg Neci + 200 mg Pembro|"Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 every 21 days followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21-day cycles in participants with Stage IV NSCLC of squamous and nonsquamous histology.~Part C were Japan participants."
11236826|NCT02451930|OG000|Outcome|Part A Cohort 2, Part B: 800 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part B participants with Stage IV NSCLC of squamous and nonsquamous histology and Part A cohort 2 participants with all histologies.
11236827|NCT02451930|OG000|Outcome|Part A Cohort 2 and Part B: 800 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part B participants with Stage IV NSCLC of squamous and nonsquamous histology and Part A cohort 2 participants with all histologies.
11236828|NCT02451930|EG000|Reported Event|Part A Cohort 1: 600 mg Neci + 200 mg Pembro|Participants received 200 mg pembrolizumab (pembro) absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 600 mg necitumumab (Neci) absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC (all histologies).
11236829|NCT02451930|EG001|Reported Event|Part A Cohort 2, Part B and Part C: 800mg Neci + 200mg Pembro|"Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part B and C participants with Stage IV NSCLC of squamous and nonsquamous histology and Part A cohort 2 participants with any histology.~Part C were Japan participants."
11236830|NCT02451995|BG000|Baseline|Ripple Mapping Guided AT Ablation|"Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation~Ripple Mapping guided AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping"
11236831|NCT02451995|BG001|Baseline|Conventional AT Ablation|"Standard activation mapping and entrainment will be used to guide ablation.~Conventional AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of activation mapping and entrainment"
11236832|NCT02451995|BG002|Baseline|Total|Total of all reporting groups
11236833|NCT02451995|FG000|Participant Flow|Ripple Mapping Guided AT Ablation|"Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation~Ripple Mapping guided AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping"
11236834|NCT02451995|FG001|Participant Flow|Conventional Local Activation Time Mapping Ablation|"Standard activation mapping will be used to guide ablation.~Conventional AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of activation mapping"
11236835|NCT02451995|OG000|Outcome|Ripple Mapping Guided AT Ablation|"Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation~Ripple Mapping guided AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping"
11236836|NCT02451995|OG001|Outcome|Conventional AT Ablation|"Standard activation mapping will be used to guide ablation.~Conventional AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of activation mapping"
11236837|NCT02451995|EG000|Reported Event|Ripple Mapping Guided AT Ablation|"Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation~Ripple Mapping guided AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping"
11236838|NCT02451995|EG001|Reported Event|Conventional AT Ablation|"Standard activation mapping will be used to guide ablation.~Conventional AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of activation mapping"
11236839|NCT02452034|BG000|Baseline|3.5 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11341524|NCT03683719|BG001|Baseline|Delgocitinib Cream 3 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11236840|NCT02452034|BG001|Baseline|3.5 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236841|NCT02452034|BG002|Baseline|4.5 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236842|NCT02452034|BG003|Baseline|4.5 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236843|NCT02452034|BG004|Baseline|6 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236844|NCT02452034|BG005|Baseline|6 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236845|NCT02452034|BG006|Baseline|Total|Total of all reporting groups
11236846|NCT02452034|FG000|Participant Flow|3.5 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236847|NCT02452034|FG001|Participant Flow|3.5 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236848|NCT02452034|FG002|Participant Flow|4.5 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236849|NCT02452034|FG003|Participant Flow|4.5 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236850|NCT02452034|FG004|Participant Flow|6 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236851|NCT02452034|FG005|Participant Flow|6 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236852|NCT02452034|OG000|Outcome|3.5 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236853|NCT02452034|OG001|Outcome|3.5 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236854|NCT02452034|OG002|Outcome|4.5 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236855|NCT02452034|OG003|Outcome|4.5 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236856|NCT02452034|OG004|Outcome|6 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236857|NCT02452034|OG005|Outcome|6 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236858|NCT02452034|EG000|Reported Event|3.5 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236859|NCT02452034|EG001|Reported Event|3.5 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236860|NCT02452034|EG002|Reported Event|4.5 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236861|NCT02452034|EG003|Reported Event|4.5 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236862|NCT02452034|EG004|Reported Event|6.0 mg/kg POS (2<7 Years Old)|Children 2 to less than 7 years of age received POS at 6 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236863|NCT02452034|EG005|Reported Event|6.0 mg/kg POS (7-17 Years Old)|Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
11236864|NCT02452047|BG000|Baseline|Group 1: Imipenem+Cilastatin/Relebactam|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem-nonsusceptible but imipenem/relebactam- and colistin-susceptible pathogens were randomized to receive imipenem+cilastatin/relebactam IV infusion once every 6 hours and placebo for colistimethate sodium IV infusion once every 12 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236865|NCT02452047|BG001|Baseline|Group 2: Colistimethate Sodium + Imipenem+Cilastatin|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem-nonsusceptible but imipenem/relebactam- and colistin-susceptible pathogens were randomized to receive colistimethate sodium IV infusion once every 12 hours and imipenem+cilastatin IV infusion once every 6 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236866|NCT02452047|BG002|Baseline|Group 3: Open-Label Imipenem+Cilastatin/Relebactam|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem- and colistin-nonsusceptible pathogens received open-label imipenem+cilastatin/relebactam IV infusion once every 6 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236867|NCT02452047|BG003|Baseline|Total|Total of all reporting groups
11236868|NCT02452047|FG000|Participant Flow|Group 1: Imipenem+Cilastatin/Relebactam|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem-nonsusceptible but imipenem/relebactam- and colistin-susceptible pathogens were randomized to receive imipenem+cilastatin/relebactam IV infusion once every 6 hours and placebo for colistimethate sodium IV infusion once every 12 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236869|NCT02452047|FG001|Participant Flow|Group 2: Colistimethate Sodium + Imipenem+Cilastatin|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem-nonsusceptible but imipenem/relebactam- and colistin-susceptible pathogens were randomized to receive colistimethate sodium IV infusion once every 12 hours and imipenem+cilastatin IV infusion once every 6 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236870|NCT02452047|FG002|Participant Flow|Group 3: Open-Label Imipenem+Cilastatin/Relebactam|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem- and colistin-nonsusceptible pathogens received open-label imipenem+cilastatin/relebactam IV infusion once every 6 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236871|NCT02452047|OG000|Outcome|Group 1: Imipenem+Cilastatin/Relebactam|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem-nonsusceptible but imipenem/relebactam- and colistin-susceptible pathogens were randomized to receive imipenem+cilastatin/relebactam IV infusion once every 6 hours and placebo for colistimethate sodium IV infusion once every 12 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236872|NCT02452047|OG001|Outcome|Group 2: Colistimethate Sodium + Imipenem+Cilastatin|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem-nonsusceptible but imipenem/relebactam- and colistin-susceptible pathogens were randomized to receive colistimethate sodium IV infusion once every 12 hours and imipenem+cilastatin IV infusion once every 6 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236873|NCT02452047|OG002|Outcome|Group 3: Open-Label Imipenem+Cilastatin/Relebactam|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem- and colistin-nonsusceptible pathogens received open-label imipenem+cilastatin/relebactam IV infusion once every 6 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236874|NCT02452047|EG000|Reported Event|Group 1: Imipenem+Cilastatin/Relebactam|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem-nonsusceptible but imipenem/relebactam- and colistin-susceptible pathogens were randomized to receive imipenem+cilastatin/relebactam IV infusion once every 6 hours and placebo for colistimethate sodium IV infusion once every 12 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236875|NCT02452047|EG001|Reported Event|Group 2: Colistimethate Sodium + Imipenem+Cilastatin|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem-nonsusceptible but imipenem/relebactam- and colistin-susceptible pathogens were randomized to receive colistimethate sodium IV infusion once every 12 hours and imipenem+cilastatin IV infusion once every 6 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236876|NCT02452047|EG002|Reported Event|Group 3: Open-Label Imipenem+Cilastatin/Relebactam|Participants with HABP, VABP, cIAI, or cUTI caused by imipenem- and colistin-nonsusceptible pathogens received open-label imipenem+cilastatin/relebactam IV infusion once every 6 hours for 5 to 21 days (cIAI and cUTI) or for 7 to 21 days (HABP or VABP).
11236877|NCT02452060|BG000|Baseline|Placebo|Placebo Comparator: 0.4mg/kg saline infusion
11236878|NCT02452060|BG001|Baseline|Ketamine|Ketamine: 0.4mg/kg infusion
11236879|NCT02452060|BG002|Baseline|Total|Total of all reporting groups
11236880|NCT02452060|FG000|Participant Flow|Treatment/Placebo|"saline infusion~Placebo Comparator: 0.4mg/kg infusion"
10961842|NCT00863265|FG004|Participant Flow|Crossover Order CAB|"Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.~A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols."
11236881|NCT02452060|FG001|Participant Flow|Treatment|"ketamine (0.4mg/kg)~Ketamine: 0.4mg/kg infusion"
11185286|NCT02093819|FG005|Participant Flow|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185287|NCT02093819|FG006|Participant Flow|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185288|NCT02093819|FG007|Participant Flow|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185289|NCT02093819|OG000|Outcome|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h
11185290|NCT02093819|OG001|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185291|NCT02093819|OG002|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185292|NCT02093819|OG003|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185293|NCT02093819|OG004|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185294|NCT02093819|OG005|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185295|NCT02093819|OG006|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185296|NCT02093819|OG007|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185297|NCT02093819|OG000|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185298|NCT02093819|OG001|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185299|NCT02093819|OG002|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185300|NCT02093819|OG003|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185301|NCT02093819|OG004|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185302|NCT02093819|OG005|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185303|NCT02093819|OG006|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185304|NCT02093819|EG000|Reported Event|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185305|NCT02093819|EG001|Reported Event|BI 416970 10 mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185306|NCT02093819|EG002|Reported Event|BI 416970 25 mg|The medication was administered as a single oral dose (dose = 25 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185307|NCT02093819|EG003|Reported Event|BI 416970 50 mg|The medication was administered as a single oral dose (dose = 50 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185308|NCT02093819|EG004|Reported Event|BI 416970 100 mg|The medication was administered as a single oral dose (dose = 100 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185309|NCT02093819|EG005|Reported Event|BI 416970 200 mg|The medication was administered as a single oral dose (dose = 200 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185310|NCT02093819|EG006|Reported Event|BI 416970 400 mg|The medication was administered as a single oral dose (dose = 400 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185311|NCT02093819|EG007|Reported Event|BI 416970 600 mg|The medication was administered as a single oral dose (dose = 600 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
11185312|NCT02093819|EG008|Reported Event|Total BI 416970 Treatment|All patients affected by AEs during administration of BI 416970 medication .
11185313|NCT02093819|EG009|Reported Event|Total Treatment|All patients affected by AEs during entire treatment period.
11358062|NCT03738241|FG007|Participant Flow|"2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03"|"Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11358063|NCT03738241|FG008|Participant Flow|"A/H7 IIV Naïve |2017 A/H7N9 IIV"|"Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11358064|NCT03738241|FG009|Participant Flow|"A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03"|"Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).~Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.~Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine."
11358065|NCT03738241|OG000|Outcome|"2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV"|2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358066|NCT03738241|OG001|Outcome|"2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358067|NCT03738241|OG002|Outcome|"2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV"|2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358068|NCT03738241|OG003|Outcome|"2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358069|NCT03738241|OG004|Outcome|"2013 A/H7N9 IIV|2017 A/H7N9 IIV"|2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358070|NCT03738241|OG005|Outcome|"2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358071|NCT03738241|OG006|Outcome|"2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV"|2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358072|NCT03738241|OG007|Outcome|"2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358073|NCT03738241|OG008|Outcome|"A/H7 IIV Naïve |2017 A/H7N9 IIV"|3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358074|NCT03738241|OG009|Outcome|"A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03"|3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358075|NCT03738241|EG000|Reported Event|"2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV"|2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358076|NCT03738241|EG001|Reported Event|"2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358077|NCT03738241|EG002|Reported Event|"2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV"|2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11191674|NCT02132936|OG000|Outcome|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
11358078|NCT03738241|EG003|Reported Event|"2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11185314|NCT02093897|BG000|Baseline|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
11358079|NCT03738241|EG004|Reported Event|"2013 A/H7N9 IIV|2017 A/H7N9 IIV"|2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11185315|NCT02093897|FG000|Participant Flow|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an intravenous (IV) infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the World Federation of Hemophilia (WFH), with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
11185316|NCT02093897|OG000|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
11185317|NCT02093897|OG000|Outcome|On-demand|Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions.
11185318|NCT02093897|OG001|Outcome|Prophylaxis|Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary.
11185319|NCT02093897|OG000|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
11185320|NCT02093897|OG001|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
11185321|NCT02093897|OG000|Outcome|Pharmacokinetic Population|The Pharmacokinetic (PK) Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
11185322|NCT02093897|OG000|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
11185323|NCT02093897|OG000|Outcome|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
11185324|NCT02093897|EG000|Reported Event|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
11185325|NCT02093923|BG000|Baseline|DX-2930, Cohort 1|Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185326|NCT02093923|BG001|Baseline|DX-2930, Cohort 2|Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185327|NCT02093923|BG002|Baseline|DX-2930, Cohort 3|Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185328|NCT02093923|BG003|Baseline|DX-2930, Cohort 4|Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11236882|NCT02452060|OG000|Outcome|Treatment/Placebo|"saline infusion~Placebo Comparator: 0.4mg/kg infusion"
11236883|NCT02452060|OG001|Outcome|Treatment|"ketamine (0.4mg/kg)~Ketamine: 0.4mg/kg infusion"
11236884|NCT02452060|EG000|Reported Event|Treatment/Placebo|"saline infusion~Placebo Comparator: 0.4mg/kg infusion"
11236885|NCT02452060|EG001|Reported Event|Treatment|"ketamine (0.4mg/kg)~Ketamine: 0.4mg/kg infusion"
11236886|NCT02452190|BG000|Baseline|Placebo|Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
11236887|NCT02452190|BG001|Baseline|Reslizumab 110 mg|Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
11236888|NCT02452190|BG002|Baseline|Total|Total of all reporting groups
11236889|NCT02452190|FG000|Participant Flow|Placebo|Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
11236890|NCT02452190|FG001|Participant Flow|Reslizumab 110 mg|Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
11236891|NCT02452190|OG000|Outcome|Placebo|Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
11236892|NCT02452190|OG001|Outcome|Reslizumab 110 mg|Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
11236893|NCT02452190|EG000|Reported Event|Placebo|Matching placebo administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
11358080|NCT03738241|EG005|Reported Event|"2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11236894|NCT02452190|EG001|Reported Event|Reslizumab 110 mg|Reslizumab 110 milligrams (mg) administered subcutaneously once every 4 weeks (+/-7 days) for a total of 13 doses.
11236895|NCT02452320|BG000|Baseline|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
11236896|NCT02452320|BG001|Baseline|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
11236897|NCT02452320|BG002|Baseline|Total|Total of all reporting groups
11236898|NCT02452320|FG000|Participant Flow|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
11236899|NCT02452320|FG001|Participant Flow|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
11236900|NCT02452320|OG000|Outcome|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
11236901|NCT02452320|OG001|Outcome|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
11236902|NCT02452320|EG000|Reported Event|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
11236903|NCT02452320|EG001|Reported Event|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
11236904|NCT02452346|BG000|Baseline|All Patients|"Tosedostat 120 mg PO once daily will be administered.~Tosedostat: 120 mg PO once daily continuously for each 28 day treatment cycle"
11236905|NCT02452346|FG000|Participant Flow|All Patients|"Tosedostat 120 mg PO once daily will be administered.~Tosedostat: 120 mg PO once daily continuously for each 28 day treatment cycle"
11236906|NCT02452346|OG000|Outcome|All Patients|"Tosedostat 120 mg PO once daily will be administered.~Tosedostat: 120 mg PO once daily continuously for each 28 day treatment cycle"
11236907|NCT02452346|EG000|Reported Event|All Patients|"Tosedostat 120 mg PO once daily will be administered.~Tosedostat: 120 mg PO once daily continuously for each 28 day treatment cycle"
11236908|NCT02452424|BG000|Baseline|Dose Escalation: 400 mg/Day|Participants received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 400 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 200 mg in the evening)..
11236909|NCT02452424|BG001|Baseline|Dose Escalation: 600 mg/Day|Participants received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236910|NCT02452424|BG002|Baseline|Dose Escalation: 600 mg/Day (Liver Metastases|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236911|NCT02452424|BG003|Baseline|Dose Escalation: 600 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11185329|NCT02093923|BG004|Baseline|Placebo|Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185330|NCT02093923|BG005|Baseline|Total|Total of all reporting groups
11185331|NCT02093923|FG000|Participant Flow|DX-2930, Cohort 1|Participants received 30 milligram (mg) dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185332|NCT02093923|FG001|Participant Flow|DX-2930, Cohort 2|Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185333|NCT02093923|FG002|Participant Flow|DX-2930, Cohort 3|Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185334|NCT02093923|FG003|Participant Flow|DX-2930, Cohort 4|Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185335|NCT02093923|FG004|Participant Flow|Placebo|Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185336|NCT02093923|OG000|Outcome|DX-2930, Cohort 1|Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185337|NCT02093923|OG001|Outcome|DX-2930, Cohort 2|Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185338|NCT02093923|OG002|Outcome|DX-2930, Cohort 3|Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185339|NCT02093923|OG003|Outcome|DX-2930, Cohort 4|Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185340|NCT02093923|OG004|Outcome|Placebo|Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185341|NCT02093923|OG000|Outcome|DX-2930, Cohort 3|Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185342|NCT02093923|OG001|Outcome|DX-2930, Cohort 4|Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185343|NCT02093923|OG002|Outcome|DX-2930, Combined Cohort 3 and Cohort 4|Participants received 300 mg and 400 mg doses of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185344|NCT02093923|OG003|Outcome|Placebo|Participants received placebo matched to 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185345|NCT02093923|EG000|Reported Event|DX-2930, Cohort 1|Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185346|NCT02093923|EG001|Reported Event|DX-2930, Cohort 2|Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185347|NCT02093923|EG002|Reported Event|DX-2930, Cohort 3|Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185348|NCT02093923|EG003|Reported Event|DX-2930, Cohort 4|Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185349|NCT02093923|EG004|Reported Event|Placebo|Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.
11185350|NCT02093949|BG000|Baseline|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.
11185351|NCT02093949|BG001|Baseline|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
11185352|NCT02093949|BG002|Baseline|Total|Total of all reporting groups
11185353|NCT02093949|FG000|Participant Flow|Substrate Ablation|Between September 2013 and July 2014, 105 patients with AF were prospectively enrolled at three centers performing substrate ablation (without pulmonary vein isolation) routinely
11185354|NCT02093949|FG001|Participant Flow|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
11185355|NCT02093949|OG000|Outcome|Substrate Ablation|Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
11185356|NCT02093949|OG001|Outcome|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
11185357|NCT02093949|OG000|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
11185358|NCT02093949|OG001|Outcome|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
11185359|NCT02093949|OG000|Outcome|Substrate Ablation Long Term Follow Up|"Out of the 105 patients included in the substrate ablation arm, only 96 were included in the long term follow-up group.~9 patients (8.6%) did not complete the follow up: 1 patient died 2 months before the end of follow-up (myocardial infarction) and 8 were lost to follow-up because of relocation."
11185360|NCT02093949|OG001|Outcome|Historical Control Long Term Follow-up|"Out of the 47 patients included in the validation set arm, only 42 finished the 18-mlonth follow-up. 2 patients were lost to follow-up~Population at the end of follow up : 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"
11185361|NCT02093949|OG000|Outcome|Substrate Ablation Long Term Follow-up|"Out of the 105 patients included in the substrate ablation arm, only 96 were included in the long term follow-up group.~9 patients (8.6%) did not complete the follow up: 1 patient died 2 months before the end of follow-up (myocardial infarction) and 8 were lost to follow-up because of relocation."
11185362|NCT02093949|OG001|Outcome|Historical Control Long Term Follow-up|Population at the end of follow up : 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)
11185363|NCT02093949|OG000|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.
11185364|NCT02093949|OG001|Outcome|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
11185365|NCT02093949|EG000|Reported Event|Substrate Ablation|Study population (n=105)
11185366|NCT02093949|EG001|Reported Event|Historical Control|Validation set (n=47)
11185367|NCT02093962|BG000|Baseline|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed~TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
11185368|NCT02093962|BG001|Baseline|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed~Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
11185369|NCT02093962|BG002|Baseline|Total|Total of all reporting groups
11185370|NCT02093962|FG000|Participant Flow|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed~TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
11185371|NCT02093962|FG001|Participant Flow|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed~Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
11185372|NCT02093962|OG000|Outcome|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed~TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
11185373|NCT02093962|OG001|Outcome|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed~Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
11185374|NCT02093962|EG000|Reported Event|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed~TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
11185375|NCT02093962|EG001|Reported Event|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed~Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
11185376|NCT02094118|BG000|Baseline|Standard of Care Red Blood Cell Transfusion|"Red blood cells that are administered in the normal fashion.~Standard of care red blood cell transfusion."
11185377|NCT02094118|BG001|Baseline|Point-of-Care Washed Red Blood Cell Transfusion|"Red blood cells that are washed at the point-of-care.~Point-of-care washed red blood cell transfusion."
11185378|NCT02094118|BG002|Baseline|Total|Total of all reporting groups
11185379|NCT02094118|FG000|Participant Flow|Standard of Care Red Blood Cell Transfusion|"Red blood cells that are administered as standard of care.~Standard of care red blood cell transfusion."
11185380|NCT02094118|FG001|Participant Flow|Point-of-Care Washed Red Blood Cell Transfusion|"Red blood cells that are washed at the point-of-care.~Point-of-care washed red blood cell transfusion."
11185381|NCT02094118|OG000|Outcome|Standard of Care Red Blood Cell Transfusion|Red blood cells transfusion that were administered in the standard of care
11185382|NCT02094118|OG001|Outcome|Point-of-Care Washed Red Blood Cell Transfusion|Red blood cells transfusion that were washed at the point-of-care.
11185383|NCT02094118|OG000|Outcome|Standard of Care Red Blood Cell Transfusion|"Red blood cells that are administered as standard of care.~Standard of care red blood cell transfusion."
11185384|NCT02094118|OG001|Outcome|Point-of-Care Washed Red Blood Cell Transfusion|"Red blood cells that are washed at the point-of-care.~Point-of-care washed red blood cell transfusion."
11185385|NCT02094118|OG000|Outcome|Standard of Care Red Blood Cell Transfusion|Red blood cells that are administered as standard of care.
11185386|NCT02094118|OG001|Outcome|Point-of-Care Washed Red Blood Cell Transfusion|Red blood cells that are washed at the point-of-care.
11185387|NCT02094118|EG000|Reported Event|Standard of Care Red Blood Cell Transfusion|Red blood cells transfusion that were administered in the standard of care
11185388|NCT02094118|EG001|Reported Event|Point-of-Care Washed Red Blood Cell Transfusion|Red blood cells transfusion that were washed at the point-of-care.
11185389|NCT02094300|BG000|Baseline|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
10961843|NCT00863265|FG005|Participant Flow|Crossover Order CBA|"Subjects will undergo 3 periods of 21 days on a controlled diet plus phytosterols/placebo and ezetimibe/placebo. A washout of 7 days occurs between periods.~A. Phytosterols 2000 mg/day and ezetimibe 10 mg/day. B. Phytosterol placebo and ezetimibe placebo. C. Phytosterol placebo and active ezetimibe 10 mg/day. ezetimibe plus phytosterols."
11185390|NCT02094300|FG000|Participant Flow|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
11185391|NCT02094300|OG000|Outcome|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
11185392|NCT02094300|EG000|Reported Event|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
11185393|NCT02094326|BG000|Baseline|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
11185394|NCT02094326|FG000|Participant Flow|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
11185395|NCT02094326|OG000|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
11185396|NCT02094326|OG000|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the classification of rheumatoid arthritis (ACR) 2010 criteria from 2008 to 2012, and initiated on at least one disease-modifying antirheumatic drug (DMARD) during this period.
11185397|NCT02094326|EG000|Reported Event|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
11185398|NCT02094417|BG000|Baseline|AMG531 (Dose 1)|AMG531: 1 μg/kg, subcutaneous, once weekly
11185399|NCT02094417|BG001|Baseline|AMG531 (Dose 3)|AMG531: 3 μg/kg, subcutaneous, once weekly
11185400|NCT02094417|BG002|Baseline|AMG531 (Dose 2)|AMG531: 6 μg/kg, subcutaneous, once weekly
11185401|NCT02094417|BG003|Baseline|AMG531 (Dose 4)|AMG531: 10 μg/kg, subcutaneous, once weekly
11185402|NCT02094417|BG004|Baseline|Total|Total of all reporting groups
11185403|NCT02094417|FG000|Participant Flow|AMG531 (Dose 1)|AMG531: 1 μg/kg, subcutaneous, once weekly
11185404|NCT02094417|FG001|Participant Flow|AMG531 (Dose 2)|AMG531: 3 μg/kg, subcutaneous, once weekly
11185405|NCT02094417|FG002|Participant Flow|AMG531 (Dose 3)|AMG531: 6 μg/kg, subcutaneous, once weekly
11185406|NCT02094417|FG003|Participant Flow|AMG531 (Dose 4)|AMG531: 10 μg/kg, subcutaneous, once weekly
11185407|NCT02094417|OG000|Outcome|AMG531 (Dose 1)|AMG531: 1 μg/kg, subcutaneous, once weekly
11185408|NCT02094417|OG001|Outcome|AMG531 (Dose 2)|AMG531: 3 μg/kg, subcutaneous, once weekly
11185409|NCT02094417|OG002|Outcome|AMG531 (Dose 3)|AMG531: 6 μg/kg, subcutaneous, once weekly
11185410|NCT02094417|OG003|Outcome|AMG531 (Dose 4)|AMG531: 10 μg/kg, subcutaneous, once weekly
11185411|NCT02094417|EG000|Reported Event|AMG531 (Dose 1)|AMG531: Subcutaneous, weekly injection
11185412|NCT02094417|EG001|Reported Event|AMG531 (Dose 2)|AMG531: Subcutaneous, weekly injection
11185413|NCT02094417|EG002|Reported Event|AMG531 (Dose 3)|AMG531: Subcutaneous, weekly injection
11185414|NCT02094417|EG003|Reported Event|AMG531 (Dose 4)|AMG531: Subcutaneous, weekly injection
11185415|NCT02094443|BG000|Baseline|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
11185416|NCT02094443|BG001|Baseline|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
11185417|NCT02094443|BG002|Baseline|Total|Total of all reporting groups
11185418|NCT02094443|FG000|Participant Flow|Alisporivir 300 mg BID|Alisporivir (ALV) 300 mg twice per day (BID) with ribavirin (RBV) for up to 24 weeks.
11185419|NCT02094443|FG001|Participant Flow|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
11185420|NCT02094443|OG000|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
11185421|NCT02094443|OG001|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
11185422|NCT02094443|EG000|Reported Event|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
11185423|NCT02094443|EG001|Reported Event|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
11185424|NCT02094534|BG000|Baseline|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules."
11185425|NCT02094534|BG001|Baseline|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
11185426|NCT02094534|BG002|Baseline|Total|Total of all reporting groups
11185427|NCT02094534|FG000|Participant Flow|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules."
11185428|NCT02094534|FG001|Participant Flow|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
11185429|NCT02094534|OG000|Outcome|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules."
11185430|NCT02094534|OG001|Outcome|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
11185431|NCT02094534|EG000|Reported Event|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules."
11185432|NCT02094534|EG001|Reported Event|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
11185433|NCT02094573|BG000|Baseline|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
11341525|NCT03683719|BG002|Baseline|Delgocitinib Cream 8 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11358081|NCT03738241|EG006|Reported Event|"2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV"|2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358082|NCT03738241|EG007|Reported Event|"2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03"|2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358083|NCT03738241|EG008|Reported Event|"A/H7 IIV Naïve |2017 A/H7N9 IIV"|3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
11358084|NCT03738241|EG009|Reported Event|"A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03"|3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
11358085|NCT03738163|BG000|Baseline|Epaderm Cream|"This is an open, non randomised single arm study.~Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device."
11358086|NCT03738163|FG000|Participant Flow|Epaderm Cream|"This is an open, non randomised single arm study.~Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device."
11358087|NCT03738163|OG000|Outcome|Epaderm Cream|"This is an open, non randomised single arm study.~Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device."
11358088|NCT03738163|EG000|Reported Event|Epaderm Cream|"This is an open, non randomised single arm study.~Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device."
11358089|NCT03738020|BG000|Baseline|HA IDF and Restylane|Subjects who were included in efficacy evaluation
11358090|NCT03738020|FG000|Participant Flow|Subjects|Subjects who enrolled in this study
10961844|NCT00863265|OG000|Outcome|Phytosterol-Deficient Diet|"Phytosterol-deficient diet plus ezetimibe placebo plus phytosterol placebo.~Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols."
11358091|NCT03738020|OG000|Outcome|HA IDF|HA IDF (YVOIRE classic): Treatment with HA IDF
11358092|NCT03738020|OG001|Outcome|Restylane|Restylane: Treatment with Restylane
11358093|NCT03738020|EG000|Reported Event|HA IDF|Subject who were injected with investigational medical device at least once
11358094|NCT03738020|EG001|Reported Event|Restylane|Subject who were injected with investigational medical device at least once
11358095|NCT03738020|EG002|Reported Event|Systemic|Subject who were injected with investigational medical device at least once
11358096|NCT03736928|BG000|Baseline|Dose Level 1 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose level 1 AbobotulinumtoxinA or placebo~AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines~placebo: treatment of glabellar facial lines"
11358097|NCT03736928|BG001|Baseline|Dose Level 2 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose level 2 AbobotulinumtoxinA or placebo~AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines~placebo: treatment of glabellar facial lines"
11358098|NCT03736928|BG002|Baseline|Dose Level 3 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo~placebo: treatment of glabellar facial lines~AbobotulinumtoxinA dose 3: treatment of glabellar facial lines"
11358099|NCT03736928|BG003|Baseline|Dose Level 4 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo~placebo: treatment of glabellar facial lines~AbobotulinumtoxinA dose 4: treatment of glabellar facial lines"
11358100|NCT03736928|BG004|Baseline|Placebo|Subjects randomized to placebo
11358101|NCT03736928|BG005|Baseline|Total|Total of all reporting groups
11358102|NCT03736928|FG000|Participant Flow|Dose Level 1 AbobotulinumtoxinA|"Subjects randomized (4:1) to AbobotulinumtoxinA or placebo~AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines~placebo: treatment of glabellar facial lines"
11358103|NCT03736928|FG001|Participant Flow|Dose Level 2 AbobotulinumtoxinA|"Subjects randomized (4:1) to AbobotulinumtoxinA or placebo~AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines~placebo: treatment of glabellar facial lines"
11358104|NCT03736928|FG002|Participant Flow|Dose Level 3 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo~placebo: treatment of glabellar facial lines~AbobotulinumtoxinA dose 3: treatment of glabellar facial lines"
11358105|NCT03736928|FG003|Participant Flow|Dose Level 4 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo~placebo: treatment of glabellar facial lines~AbobotulinumtoxinA dose 4: treatment of glabellar facial lines"
11358106|NCT03736928|FG004|Participant Flow|Placebo|Subjects randomized to placebo
11358107|NCT03736928|OG000|Outcome|Dose Level 1 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose level 1 AbobotulinumtoxinA or placebo~AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines~placebo: treatment of glabellar facial lines"
11358108|NCT03736928|OG001|Outcome|Dose Level 2 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose level 2 AbobotulinumtoxinA or placebo~AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines~placebo: treatment of glabellar facial lines"
11358109|NCT03736928|OG002|Outcome|Dose Level 3 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo~placebo: treatment of glabellar facial lines~AbobotulinumtoxinA dose 3: treatment of glabellar facial lines"
11358110|NCT03736928|OG003|Outcome|Dose Level 4 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo~placebo: treatment of glabellar facial lines~AbobotulinumtoxinA dose 4: treatment of glabellar facial lines"
11185434|NCT02094573|BG001|Baseline|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
11185435|NCT02094573|BG002|Baseline|Total|Total of all reporting groups
11185436|NCT02094573|FG000|Participant Flow|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
11185437|NCT02094573|FG001|Participant Flow|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
11185438|NCT02094573|OG000|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
11185439|NCT02094573|OG001|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
11185440|NCT02094573|EG000|Reported Event|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
11185441|NCT02094573|EG001|Reported Event|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
11185442|NCT02094586|BG000|Baseline|PXVX0200 Lot A|PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
11185443|NCT02094586|BG001|Baseline|PXVX0200 Lot B|PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
11185444|NCT02094586|BG002|Baseline|PXVX0200 Lot C|PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
11185445|NCT02094586|BG003|Baseline|Placebo|Placebo physiological saline
11185446|NCT02094586|BG004|Baseline|Total|Total of all reporting groups
11185447|NCT02094586|FG000|Participant Flow|PXVX0200 Lot A|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185448|NCT02094586|FG001|Participant Flow|PXVX0200 Lot B|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185449|NCT02094586|FG002|Participant Flow|PXVX0200 Lot C|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185450|NCT02094586|FG003|Participant Flow|Placebo|"Placebo physiological saline~Placebo"
11185451|NCT02094586|OG000|Outcome|PXVX0200 Lot A|A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185452|NCT02094586|OG001|Outcome|PXVX0200 Lot B|A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185453|NCT02094586|OG000|Outcome|PXVX0200 Lot A|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185454|NCT02094586|OG001|Outcome|PXVX0200 Lot B|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185455|NCT02094586|OG002|Outcome|PXVX0200 Lot C|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185456|NCT02094586|OG003|Outcome|Placebo|Placebo physiological saline
11185457|NCT02094586|OG000|Outcome|PXVX0200 (Lot A, B and C)|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185458|NCT02094586|OG001|Outcome|Placebo|Placebo physiological saline
11185459|NCT02094586|OG000|Outcome|PXVX0200|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185460|NCT02094586|OG003|Outcome|PXVX0200 (Lot A, B and C)|"PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension~PXVX0200: comparing 3 lots of PXVX0200"
11185461|NCT02094586|OG004|Outcome|Placebo|"Placebo physiological saline~Placebo"
11185462|NCT02094586|OG000|Outcome|PXVX0200 Lot B|A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185463|NCT02094586|OG001|Outcome|PXVX0200 Lot C|A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185464|NCT02094586|OG000|Outcome|PXVX0200 Lot A|A of single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185465|NCT02094586|OG001|Outcome|PXVX0200 Lot C|A of single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185466|NCT02094586|EG000|Reported Event|PXVX0200 Lot A|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185467|NCT02094586|EG001|Reported Event|PXVX0200 Lot B|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185468|NCT02094586|EG002|Reported Event|PXVX0200 Lot C|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension
11185469|NCT02094586|EG003|Reported Event|All PXVX0200 Lots|All PXVX0200 Lots
11185470|NCT02094586|EG004|Reported Event|Placebo|Placebo physiological saline
11185471|NCT02094612|BG000|Baseline|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
11185472|NCT02094612|BG001|Baseline|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
11185473|NCT02094612|BG002|Baseline|Total|Total of all reporting groups
11185474|NCT02094612|FG000|Participant Flow|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
10961845|NCT00863265|OG001|Outcome|Diet Plus Ezetimibe|"Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus phytosterol placebo.~Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols."
11185475|NCT02094612|FG001|Participant Flow|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
11358111|NCT03736928|OG004|Outcome|Placebo|Subjects randomized to placebo
11358112|NCT03736928|EG000|Reported Event|Dose Level 1 AbobotulinumtoxinA|"Subjects randomized (4:1) to AbobotulinumtoxinA or placebo~AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines~placebo: treatment of glabellar facial lines"
11358113|NCT03736928|EG001|Reported Event|Dose Level 2 AbobotulinumtoxinA|"Subjects randomized (4:1) to AbobotulinumtoxinA or placebo~AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines~placebo: treatment of glabellar facial lines"
11358114|NCT03736928|EG002|Reported Event|Dose Level 3 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo~placebo: treatment of glabellar facial lines~AbobotulinumtoxinA dose 3: treatment of glabellar facial lines"
11358115|NCT03736928|EG003|Reported Event|Dose Level 4 AbobotulinumtoxinA|"Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo~placebo: treatment of glabellar facial lines~AbobotulinumtoxinA dose 4: treatment of glabellar facial lines"
11358116|NCT03736928|EG004|Reported Event|Placebo|Subjects randomized to placebo
11358117|NCT03736785|BG000|Baseline|LY3209590 Algorithm 1|Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 milligram mg.dL
11358118|NCT03736785|BG001|Baseline|LY3209590 Algorithm 2|Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
11358119|NCT03736785|BG002|Baseline|Insulin Degludec|Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
11358120|NCT03736785|BG003|Baseline|Total|Total of all reporting groups
10961846|NCT00863265|OG002|Outcome|Diet Plus Ezetimibe Plus Phytosterols|"Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus 2000 mg/day of phytosterols.~Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols."
10961847|NCT00863265|OG000|Outcome|Phytosterol-Deficient Diet|Phytosterol-deficient diet plus ezetimibe placebo plus phytosterol placebo
10961848|NCT00863265|OG001|Outcome|Diet Plus Ezetimibe|Phytosterol-deficient diet plus ezetimibe plus phytosterol placebo
10961849|NCT00863265|OG002|Outcome|Diet Plus Ezetimibe Plus Phytosterols|Phytosterol-deficient diet plus ezetimibe plus phytosterols
10961850|NCT00863265|OG000|Outcome|Phytosterol-Deficient Diet|Phytosterol-deficient diet plus ezetimibe placebo plus phytosterol placebo.
10961851|NCT00863265|OG001|Outcome|Phytosterol-Deficient Diet Plus Ezetimibe|Phytosterol-Deficient Diet Plus Ezetimibe Plus Phytosterol Placebo.
10961852|NCT00863265|OG002|Outcome|Phytosterol-Deficient Diet Plus Ezetimibe Plus Phytosterols|Phytosterol-deficient diet plus ezetimibe plus phytosterols.
11185476|NCT02094612|OG000|Outcome|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
11185477|NCT02094612|OG001|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
11358121|NCT03736785|FG000|Participant Flow|LY3209590 Algorithm 1|Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
11358122|NCT03736785|FG001|Participant Flow|LY3209590 Algorithm 2|Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
11358123|NCT03736785|FG002|Participant Flow|Insulin Degludec|Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
11358124|NCT03736785|OG000|Outcome|LY3209590 Algorithm 1|Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
11358125|NCT03736785|OG001|Outcome|LY3209590 Algorithm 2|Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
11358126|NCT03736785|OG002|Outcome|Insulin Degludec|Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
11358127|NCT03736785|OG000|Outcome|Insulin Degludec|Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
11358128|NCT03736785|EG000|Reported Event|LY3209590 Algorithm 1|Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
11358129|NCT03736785|EG001|Reported Event|LY3209590 Algorithm 2|Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
11358130|NCT03736785|EG002|Reported Event|Insulin Degludec|Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
11376193|NCT01371981|EG004|Reported Event|Arm C (Cohort 3)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO days 11-28.~IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36.~INT I: Pts receive cytarabine IT & AE cin Arm A, INT II, & sorafenib tosylate PO daily days 6-28.~INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), & sorafenib tosylate PO days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2.~Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year."
11376194|NCT01371981|EG005|Reported Event|Arm D|INDUCTION I: Patients with unknown FLT3/ITD status prior to study enrollment receive cytarabine IT and ADE chemotherapy as in Arm A, Induction I. If patients are determined to be HR FLT3/ITD+ no later than the end of Induction I they will be eligible to participate in Arm C.
11376195|NCT01302834|BG000|Baseline|IMRT + Cisplatin|"Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin~Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy."
11376196|NCT01302834|BG001|Baseline|IMRT + Cetuximab|"Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab~Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy."
11376197|NCT01302834|BG002|Baseline|Total|Total of all reporting groups
11376198|NCT01302834|FG000|Participant Flow|IMRT + Cisplatin|"Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin~Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy."
11376199|NCT01302834|FG001|Participant Flow|IMRT + Cetuximab|"Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab~Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy."
11376200|NCT01302834|OG000|Outcome|IMRT + Cisplatin|"Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin~Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy."
11376201|NCT01302834|OG001|Outcome|IMRT + Cetuximab|"Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab~Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy."
11376202|NCT01302834|EG000|Reported Event|IMRT + Cisplatin|"Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin~Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy."
11376203|NCT01302834|EG001|Reported Event|IMRT + Cetuximab|"Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab~Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy."
11376204|NCT01286272|BG000|Baseline|Arm A (Ofatumumab, Bendamustine Hydrochloride)|"INDUCTION: Patients receive:> 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. >~> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses."
11376205|NCT01286272|BG001|Baseline|Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)|"INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. >~> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses."
10961853|NCT00863265|EG000|Reported Event|Phytosterol-Deficient Diet|"Phytosterol-deficient diet plus ezetimibe placebo plus phytosterol placebo.~Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols."
11376206|NCT01286272|BG002|Baseline|Total|Total of all reporting groups
11376207|NCT01286272|FG000|Participant Flow|Arm A (Ofatumumab, Bendamustine Hydrochloride)|"INDUCTION: Patients receive:> 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. >~> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses."
11358131|NCT03736031|BG000|Baseline|Intervention (Promotora)|"The intervention group will have three face-to-face meetings with the promotora. Participant will continue to receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records.~Intervention (Promotora): If the patient is in the intervention group, the promotora will call the patient in order to invite them to a meeting. Meetings will be arranged by the promotora and the patients. A total of 2 group meetings will be required by all participants and 1 family meeting."
11358132|NCT03736031|BG001|Baseline|Self-Education (Control)|Participant will receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records.
11358133|NCT03736031|BG002|Baseline|Total|Total of all reporting groups
10961854|NCT00863265|EG001|Reported Event|Diet Plus Ezetimibe|"Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus phytosterol placebo.~Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols."
10961855|NCT00863265|EG002|Reported Event|Diet Plus Ezetimibe Plus Phytosterols|"Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus 2000 mg/day of phytosterols.~Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols: Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols."
10961856|NCT00863304|BG000|Baseline|Placebo|Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
10961857|NCT00863304|BG001|Baseline|Tanezumab 5 mg + Placebo|Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
10961858|NCT00863304|BG002|Baseline|Tanezumab 10 mg + Placebo|Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
11185478|NCT02094612|EG000|Reported Event|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
11185479|NCT02094612|EG001|Reported Event|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
10961859|NCT00863304|BG003|Baseline|Naproxen + Placebo|Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
10961860|NCT00863304|BG004|Baseline|Total|Total of all reporting groups
10961861|NCT00863304|FG000|Participant Flow|Placebo|Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
10961862|NCT00863304|FG001|Participant Flow|Tanezumab 5 mg + Placebo|Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
10961863|NCT00863304|FG002|Participant Flow|Tanezumab 10 mg + Placebo|Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
10961864|NCT00863304|FG003|Participant Flow|Naproxen + Placebo|Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
10961865|NCT00863304|OG000|Outcome|Placebo|Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
10961866|NCT00863304|OG001|Outcome|Tanezumab 5 mg + Placebo|Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
10961867|NCT00863304|OG002|Outcome|Tanezumab 10 mg + Placebo|Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
10961868|NCT00863304|OG003|Outcome|Naproxen + Placebo|Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
10961869|NCT00863304|OG000|Outcome|Tanezumab 5 mg + Placebo|Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
10961870|NCT00863304|OG001|Outcome|Tanezumab 10 mg + Placebo|Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
11185480|NCT02094664|BG000|Baseline|Control|Standard dry oxygen therapy
11185481|NCT02094664|BG001|Baseline|Treatment|Heated and humidified oxygen therapy
11185482|NCT02094664|BG002|Baseline|Total|Total of all reporting groups
11185483|NCT02094664|FG000|Participant Flow|Control|Standard dry oxygen therapy
11358134|NCT03736031|FG000|Participant Flow|Intervention (Promotora)|"The intervention group will have three face-to-face meetings with the promotora. Participant will continue to receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records.~Intervention (Promotora): If the patient is in the intervention group, the promotora will call the patient in order to invite them to a meeting. Meetings will be arranged by the promotora and the patients. A total of 2 group meetings will be required by all participants and 1 family meeting."
11358135|NCT03736031|FG001|Participant Flow|Self-Education (Control)|Participant will receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records.
11358136|NCT03736031|OG000|Outcome|Intervention (Promotora)|"The intervention group will have three face-to-face meetings with the promotora. Participant will continue to receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records.~Intervention (Promotora): If the patient is in the intervention group, the promotora will call the patient in order to invite them to a meeting. Meetings will be arranged by the promotora and the patients. A total of 2 group meetings will be required by all participants and 1 family meeting."
11358137|NCT03736031|OG001|Outcome|Self-Education (Control)|Participant will receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records.
11358138|NCT03736031|EG000|Reported Event|Intervention (Promotora)|"The intervention group will have three face-to-face meetings with the promotora. Participant will continue to receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records.~Intervention (Promotora): If the patient is in the intervention group, the promotora will call the patient in order to invite them to a meeting. Meetings will be arranged by the promotora and the patients. A total of 2 group meetings will be required by all participants and 1 family meeting."
11358139|NCT03736031|EG001|Reported Event|Self-Education (Control)|Participant will receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records.
11358140|NCT03735862|BG000|Baseline|Observations Group|"Patients who have undergone a hiatal hernia repair with MIROMESH.~Hepatic derived surgical matrix: Hiatal hernia repair with MIROMESH"
11358141|NCT03735862|FG000|Participant Flow|Observations Group|Patients who have undergone a hiatal hernia repair with MIROMESH.
11358142|NCT03735862|OG000|Outcome|Observations Group|Patients who have undergone a hiatal hernia repair with MIROMESH.
11358143|NCT03735862|EG000|Reported Event|Observations Group|Patients who have undergone a hiatal hernia repair with MIROMESH.
11358144|NCT03734991|BG000|Baseline|Ibrexafungerp (SCY-078)|"300 mg orally every 12 hrs for 1 day (2 doses in 1 day)~Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day"
11358145|NCT03734991|BG001|Baseline|Placebo|"Matching Placebo~Placebo: Matching placebo"
11358146|NCT03734991|BG002|Baseline|Total|Total of all reporting groups
11358147|NCT03734991|FG000|Participant Flow|Ibrexafungerp (SCY-078)|"300 mg orally every 12 hrs for 1 day (2 doses in 1 day)~Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day"
11358148|NCT03734991|FG001|Participant Flow|Placebo|"Matching Placebo~Placebo: Matching placebo"
11358149|NCT03734991|OG000|Outcome|Ibrexafungerp (SCY-078)|"300 mg orally every 12 hrs for 1 day (2 doses in 1 day)~Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day"
11358150|NCT03734991|OG001|Outcome|Placebo|"Matching Placebo~Placebo: Matching placebo"
11358151|NCT03734991|EG000|Reported Event|Ibrexafungerp (SCY-078)|"300 mg orally every 12 hrs for 1 day (2 doses in 1 day)~Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day"
11358152|NCT03734991|EG001|Reported Event|Placebo|"Matching Placebo~Placebo: Matching placebo"
11358153|NCT03734822|BG000|Baseline|Cystic Fibrosis|"Cystic fibrosis patients undergoing general anesthesia.~End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.~Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2.~Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.~Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer."
11358154|NCT03734822|FG000|Participant Flow|Cystic Fibrosis|"Cystic fibrosis patients undergoing general anesthesia.~End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.~Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2.~Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.~Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer."
11185484|NCT02094664|FG001|Participant Flow|Treatment|Heated and humidified oxygen therapy
11185485|NCT02094664|OG000|Outcome|Control|Standard dry therapy therapy
11358155|NCT03734822|OG000|Outcome|Cystic Fibrosis|"Cystic fibrosis patients undergoing general anesthesia.~End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.~Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2.~Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.~Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer."
11358156|NCT03734822|EG000|Reported Event|Cystic Fibrosis|"Cystic fibrosis patients undergoing general anesthesia.~End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.~Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2.~Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.~Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer."
11358157|NCT03734601|BG000|Baseline|TBI+TLI|"TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen)~Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning~Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days~Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)~Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.~Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days"
11358158|NCT03734601|FG000|Participant Flow|TBI+TLI|"TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen)~Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning~Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days~Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)~Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.~Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days"
11358159|NCT03734601|OG000|Outcome|TBI+TLI|"TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen)~Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning~Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days~Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)~Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.~Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days"
11358160|NCT03734601|EG000|Reported Event|TBI+TLI|"TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen)~Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning~Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days~Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)~Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.~Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days"
11358161|NCT03733899|BG000|Baseline|All Dispensed Subjects|All subjects dispensed at least one study lens.
11358162|NCT03733899|FG000|Participant Flow|Lower Lid Margin/Upper Lid Margin/Cornea|Subjects assigned to recieved two treatmens contralaterally, in the lower lid margin during period 1, the upper lid margin during period 2 and the cornea at period 3.
11358163|NCT03733899|FG001|Participant Flow|Lower Lid Margin/Cornea/Upper Lid Margin|Subjects assigned to recieved two treatmens contralaterally, in the lower lid margin during period 1, the cornea during period 2 and the upper lid margin during period 3.
11358164|NCT03733899|FG002|Participant Flow|Upper Lid Margin/Lower Lid Margin/Cornea|Subjects assigned to recieved two treatmens contralaterally, in the upper lid margin during period 1, the lower lid margin during period 2 and the cornea during period 3.
11358165|NCT03733899|FG003|Participant Flow|Upper Lid Margin/Cornea/Lower Lid Margin|Subjects assigned to recieved two treatmens contralaterally, in the upper lid margin during period 1, the cornea during period 2 and the lower lid margin during period 3.
11358166|NCT03733899|FG004|Participant Flow|Cornea/Lower Lid Margin/Upper Lid Margin|Subjects assigned to recieved two treatmens contralaterally, in the Cornea during period 1, the lower lid margin during period 2 and the upper lid maring during period 3.
11185486|NCT02094664|OG001|Outcome|Treatment|Heated and humidified oxygen therapy
11185487|NCT02094664|EG000|Reported Event|Control|Standard dry oxygen therapy
11358167|NCT03733899|FG005|Participant Flow|Cornea/Upper Lid Margin/Lower Lid Margin|Subjects assigned to recieved two treatmens contralaterally, in the Cornea during period 1, the upper lid margin during period 2 and the lower lid maring during period 3.
11358168|NCT03733899|OG000|Outcome|Test (Anesthetic)- Cornea|Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
11358169|NCT03733899|OG001|Outcome|Placebo- Cornea|Eyes that instilled the Placebo in either the right or left corneal ocular region.
11358170|NCT03733899|OG002|Outcome|Test (Anesthetic) - Upper Lid Margin|Eyes that instilled the Test in either the right or left upper lid margin.
11358171|NCT03733899|OG003|Outcome|Placebo- Upper Lid Margin|Eyes that instilled the Placebo in either the right or left upper lid margin.
11358172|NCT03733899|OG004|Outcome|Test (Anesthetic)- Lower Lid Margin|Eyes that instilled the Test in either the right or left lower lid margin.
11358173|NCT03733899|OG005|Outcome|Placebo- Lower Lid Margin|Eyes that instilled the Placebo in either the right or left lower lid margin.
11358174|NCT03733899|OG000|Outcome|Test (Anesthetic)- Corneal|Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
11358175|NCT03733899|OG001|Outcome|Test (Anesthetic) - Upper Lid Margin|Eyes that instilled the Test in either the right or left upper lid margin.
11236912|NCT02452424|BG004|Baseline|Dose Escalation: 800 mg/Day (Liver Metastases)|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11236913|NCT02452424|BG005|Baseline|Dose Escalation: 800 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening)..
11236914|NCT02452424|BG006|Baseline|Dose Expansion: Melanoma|Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236915|NCT02452424|BG007|Baseline|Dose Expansion: NSCLC|Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236916|NCT02452424|BG008|Baseline|Dose Expansion: Ovarian Cancer|Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236917|NCT02452424|BG009|Baseline|Dose Expansion: SCCHN|Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236918|NCT02452424|BG010|Baseline|Dose Expansion: GIST|Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236919|NCT02452424|BG011|Baseline|Total|Total of all reporting groups
11236920|NCT02452424|FG000|Participant Flow|Dose Escalation: 400 mg/Day|Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 200 mg in the evening).
11236921|NCT02452424|FG001|Participant Flow|Dose Escalation: 600 mg/Day|Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236922|NCT02452424|FG002|Participant Flow|Dose Escalation: 600 mg/Day (Liver Metastases|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236923|NCT02452424|FG003|Participant Flow|Dose Escalation: 600 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236924|NCT02452424|FG004|Participant Flow|Dose Escalation: 800 mg/Day (Liver Metastases)|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11236925|NCT02452424|FG005|Participant Flow|Dose Escalation: 800 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11236926|NCT02452424|FG006|Participant Flow|Dose Expansion: Melanoma|Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236927|NCT02452424|FG007|Participant Flow|Dose Expansion: NSCLC|Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236928|NCT02452424|FG008|Participant Flow|Dose Expansion: Ovarian Cancer|Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236929|NCT02452424|FG009|Participant Flow|Dose Expansion: SCCHN|Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236930|NCT02452424|FG010|Participant Flow|Dose Expansion: GIST|Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236931|NCT02452424|OG000|Outcome|Dose Escalation: 400 mg/Day|Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 200 mg in the evening).
11236932|NCT02452424|OG001|Outcome|Dose Escalation: 600 mg/Day|Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236933|NCT02452424|OG002|Outcome|Dose Escalation: 600 mg/Day (Liver Metastases|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236934|NCT02452424|OG003|Outcome|Dose Escalation: 600 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236935|NCT02452424|OG004|Outcome|Dose Escalation: 800 mg/Day (Liver Metastases)|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11358176|NCT03733899|OG002|Outcome|Test (Anesthetic)- Lower Lid Margin|Eyes that instilled the Test in either the right or left lower lid margin.
11358177|NCT03733899|EG000|Reported Event|Placebo|subjects that were exposed to the placebo during any point in the study.
11358178|NCT03733899|EG001|Reported Event|Test (Anesthetic)|Subjects that were exposed to the Anesthetic during any point in the study.
11185488|NCT02094664|EG001|Reported Event|Treatment|Heated and humidified oxygen therapy
11185489|NCT02094677|BG000|Baseline|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
11185490|NCT02094677|BG001|Baseline|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
11185491|NCT02094677|BG002|Baseline|Total|Total of all reporting groups
11185492|NCT02094677|FG000|Participant Flow|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
11185493|NCT02094677|FG001|Participant Flow|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
11185494|NCT02094677|OG000|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
11185495|NCT02094677|OG001|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
11185496|NCT02094677|OG000|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
11185497|NCT02094677|OG001|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
11185498|NCT02094677|OG000|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
11185499|NCT02094677|OG001|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
11185500|NCT02094677|OG000|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens"
11185501|NCT02094677|OG001|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens"
11185502|NCT02094677|OG001|Outcome|Control - Nelilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
11185503|NCT02094677|EG000|Reported Event|Filcon II 3 and Etafilcon A|"Participants wear one of their habitual brand lenses (etafilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.~filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.~etafilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
11185504|NCT02094677|EG001|Reported Event|Filcon II 3 and Nelfilcon A|"Participants wear one of their habitual brand lenses (nelfilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.~filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.~nelfilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
11185505|NCT02094755|BG000|Baseline|Single Cohort|"Single cohort will receive Blood draw only.~Blood draw only: Blood draw only"
11185506|NCT02094755|FG000|Participant Flow|Single Cohort|"Single cohort will receive Blood draw only.~Blood draw only: Blood draw only"
11185507|NCT02094755|OG000|Outcome|Single Cohort|Patients were included who had a diagnosis of CLI and who received uninterrupted treatment with ASA and/or clopidogrel for ≥1 week prior to platelet inhibition testing.
11185508|NCT02094755|EG000|Reported Event|Single Cohort|"Single cohort will receive Blood draw only.~Blood draw only: Blood draw only"
11185509|NCT02094872|BG000|Baseline|Arm I (Molecularly Targeted Therapy)|"Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy~therapeutic procedure~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
11185510|NCT02094872|FG000|Participant Flow|Arm I (Molecularly Targeted Therapy)|"Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy~therapeutic procedure~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
11191675|NCT02132936|OG001|Outcome|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
11191676|NCT02132936|OG001|Outcome|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
11185511|NCT02094872|OG000|Outcome|Arm I (Molecularly Targeted Therapy)|"Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy~therapeutic procedure~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
11185512|NCT02094872|EG000|Reported Event|Arm I (Molecularly Targeted Therapy)|"Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy~therapeutic procedure~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
11185513|NCT02094885|BG000|Baseline|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
11185514|NCT02094885|BG001|Baseline|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
11185515|NCT02094885|BG002|Baseline|Total|Total of all reporting groups
11185516|NCT02094885|FG000|Participant Flow|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
11185517|NCT02094885|FG001|Participant Flow|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
11185518|NCT02094885|OG000|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
11185519|NCT02094885|OG001|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
11185520|NCT02094885|EG000|Reported Event|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
11185521|NCT02094885|EG001|Reported Event|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
11185522|NCT02094898|BG000|Baseline|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.~Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
11185523|NCT02094898|FG000|Participant Flow|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.~Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
11185524|NCT02094898|OG000|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
11185525|NCT02094898|OG001|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
11185526|NCT02094898|OG002|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
11185527|NCT02094898|EG000|Reported Event|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.~Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
11185528|NCT02094937|BG000|Baseline|Period 1- FF/VI 100/25 mcg OD|Participants received FF/VI 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
11185529|NCT02094937|FG000|Participant Flow|FF/VI 100/25 mcg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
11185530|NCT02094937|FG001|Participant Flow|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11185531|NCT02094937|FG002|Participant Flow|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11185532|NCT02094937|FG003|Participant Flow|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11191677|NCT02132936|EG000|Reported Event|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
11236936|NCT02452424|OG005|Outcome|Dose Escalation: 800 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11236937|NCT02452424|OG006|Outcome|Dose Expansion: Melanoma|Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236938|NCT02452424|OG007|Outcome|Dose Expansion: NSCLC|Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236939|NCT02452424|OG008|Outcome|Dose Expansion: Ovarian Cancer|Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236940|NCT02452424|OG009|Outcome|Dose Expansion: SCCHN|Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236941|NCT02452424|OG010|Outcome|Dose Expansion: GIST|Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236942|NCT02452424|OG004|Outcome|Dose Escalation: 800 mg/Day (Liver Metastases)|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11236943|NCT02452424|OG005|Outcome|Dose Escalation: 800 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11236944|NCT02452424|EG000|Reported Event|Dose Escalation: 400 mg/Day|Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 200 mg in the evening).
11236945|NCT02452424|EG001|Reported Event|Dose Escalation: 600 mg/Day|Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236946|NCT02452424|EG002|Reported Event|Dose Escalation: 600 mg/Day (Liver Metastases|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236947|NCT02452424|EG003|Reported Event|Dose Escalation: 600 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236948|NCT02452424|EG004|Reported Event|Dose Escalation: 800 mg/Day (Liver Metastases)|Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11236949|NCT02452424|EG005|Reported Event|Dose Escalation: 800 mg/Day (no Liver Metastases)|Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily [BID] as a split dose of 400 mg in the morning and 400 mg in the evening).
11236950|NCT02452424|EG006|Reported Event|Dose Expansion: Melanoma|Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236951|NCT02452424|EG007|Reported Event|Dose Expansion: NSCLC|Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236952|NCT02452424|EG008|Reported Event|Dose Expansion: Ovarian Cancer|Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236953|NCT02452424|EG009|Reported Event|Dose Expansion: SCCHN|Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236954|NCT02452424|EG010|Reported Event|Dose Expansion: GIST|Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose of 200 mg in the morning and 400 mg in the evening).
11236955|NCT02452463|BG000|Baseline|Arm I (Nintedanib)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236956|NCT02452463|BG001|Baseline|Arm II (Placebo)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236957|NCT02452463|BG002|Baseline|Arm III (Nintedanib, Durvalumab)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Nintedanib: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236958|NCT02452463|BG003|Baseline|Total|Total of all reporting groups
11358179|NCT03733483|BG000|Baseline|Sleep Deprivation|Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
11358180|NCT03733483|FG000|Participant Flow|Sleep Deprivation|Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
11358181|NCT03733483|OG000|Outcome|Sleep Deprivation|Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
11358182|NCT03733483|EG000|Reported Event|Sleep Deprivation|Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
11358183|NCT03733470|BG000|Baseline|Nonsusceptible Smokers (NS)|8 emphysema nonsusceptible smokers recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
11358184|NCT03733470|BG001|Baseline|Susceptible Smokers (SS)|11 emphysema susceptible smokers recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
11358185|NCT03733470|BG002|Baseline|Total|Total of all reporting groups
11358186|NCT03733470|FG000|Participant Flow|Nonsusceptible Smokers (NS)|"22 subjects recruited. Pre-sildenafil we imaged with no contrast at TLC and 20% vital capacity (VC). To assess perfused blood volume (PBV), we imaged at 20% VC . For the intervention, the subject were administered 20 mg of oral Sildenafil and PBV imaging was repeated one hour after sildenafil.~One group was labeled emphysema non-susceptible (NS) and another was emphysema susceptible (SS) based upon visual identification of emphysema in non-contrast CT scans. Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications and two more were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. The study was designed to determine if the NS subjects have a greater coefficient of variation (CV) within 30x30x40 regions (approximately the size of an acinus) and whether sildenafil would eliminate the difference between medians of the per block CV histograms for NS and SS."
11358187|NCT03733470|FG001|Participant Flow|Susceptible Smoker (SS)|"22 subjects recruited. Pre-sildenafil we imaged with no contrast at TLC and 20% vital capacity (VC). To assess perfused blood volume (PBV), we imaged at 20% VC . For the intervention, the subject were administered 20 mg of oral Sildenafil and PBV imaging was repeated one hour after sildenafil.~One group was labeled emphysema non-susceptible (NS) and another was emphysema susceptible (SS) based upon visual identification of emphysema in non-contrast CT scans. Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications and two more were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. The study was designed to determine if the NS subjects have a greater coefficient of variation (CV) within 30x30x40 regions (approximately the size of an acinus) and whether sildenafil would eliminate the difference between medians of the per block CV histograms for NS and SS."
11358188|NCT03733470|OG000|Outcome|Nonsusceptible Smokers (NS)|"7 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, one dose of 20 mg Sildenafil was administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.~One dose of 20 mg Sildenafil will be given one hour before CT imaging."
11358189|NCT03733470|OG001|Outcome|Susceptible Smoker (SS)|"10 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, one dose of 20 mg Sildenafil was administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.~One dose of 20 mg Sildenafil will be given one hour before CT imaging."
11358190|NCT03733470|EG000|Reported Event|Nonsusceptible Smokers (NS)|8 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
11358191|NCT03733470|EG001|Reported Event|Susceptible Smokers (SS)|11 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
11358192|NCT03733301|BG000|Baseline|Placebo|Placebo administered orally once daily.
11358193|NCT03733301|BG001|Baseline|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11358194|NCT03733301|BG002|Baseline|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11358195|NCT03733301|BG003|Baseline|Total|Total of all reporting groups
11358196|NCT03733301|FG000|Participant Flow|Placebo|Placebo administered orally once daily.
11358197|NCT03733301|FG001|Participant Flow|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11358198|NCT03733301|FG002|Participant Flow|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11358199|NCT03733301|OG000|Outcome|Placebo|Placebo administered orally once daily.
11358200|NCT03733301|OG001|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11358201|NCT03733301|OG002|Outcome|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11358202|NCT03733301|OG001|Outcome|2 mg Baricitinib|Baricitinib 2 mg administered orally once daily.
11358203|NCT03733301|EG000|Reported Event|Placebo|Placebo administered orally once daily.
11358204|NCT03733301|EG001|Reported Event|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11358205|NCT03733301|EG002|Reported Event|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11358206|NCT03732638|BG000|Baseline|Rimegepant - Randomization Phase|Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
11358207|NCT03732638|BG001|Baseline|Placebo - Randomization Phase|Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
11358208|NCT03732638|BG002|Baseline|Total|Total of all reporting groups
11358209|NCT03732638|FG000|Participant Flow|Rimegepant - Randomization Phase|Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
11358210|NCT03732638|FG001|Participant Flow|Placebo - Randomization Phase|Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
11358211|NCT03732638|OG000|Outcome|Rimegepant - Randomization Phase|Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
11358212|NCT03732638|OG001|Outcome|Placebo - Randomization Phase|Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
11358213|NCT03732638|OG001|Outcome|Placebo - Randomization Phase|Participants received a single oral dose of matching placebo table EOD for 12 weeks.
11358214|NCT03732638|EG000|Reported Event|Rimegepant - Randomization Phase|Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
11358215|NCT03732638|EG001|Reported Event|Placebo - Randomization Phase|Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
11358216|NCT03732248|BG000|Baseline|Rapamycin (Sirolimus) 15mg|"Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.~Rapamycin: Immunosuppressive drug"
11358217|NCT03732248|BG001|Baseline|Placebo|"Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.~Placebo: Inert drug"
11358218|NCT03732248|BG002|Baseline|Total|Total of all reporting groups
11358219|NCT03732248|FG000|Participant Flow|Rapamycin (Sirolimus) 15mg|"Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.~Rapamycin: Immunosuppressive drug"
11358220|NCT03732248|FG001|Participant Flow|Placebo|"Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.~Placebo: Inert drug"
11358221|NCT03732248|OG000|Outcome|Rapamycin (Sirolimus) 15mg|"Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.~Rapamycin: Immunosuppressive drug"
11358222|NCT03732248|OG001|Outcome|Placebo|"Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.~Placebo: Inert drug"
11358223|NCT03732248|EG000|Reported Event|Rapamycin (Sirolimus) 15mg|"Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.~Rapamycin: Immunosuppressive drug"
11358224|NCT03732248|EG001|Reported Event|Placebo|"Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.~Placebo: Inert drug"
11358225|NCT03731182|BG000|Baseline|V114|Participants received a single 0.5 mL IM injection of V114 on Day 1.
11358226|NCT03731182|BG001|Baseline|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
11358227|NCT03731182|BG002|Baseline|Total|Total of all reporting groups
11358228|NCT03731182|FG000|Participant Flow|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
11358229|NCT03731182|FG001|Participant Flow|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
11358230|NCT03731182|OG000|Outcome|V114|Participants received a single 0.5 mL IM injection of V114 on Day 1.
11358231|NCT03731182|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
11358232|NCT03731182|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular IM injection of V114 on Day 1.
11358233|NCT03731182|EG000|Reported Event|V114|Participants received a single 0.5 mL IM injection of V114 on Day 1.
11358234|NCT03731182|EG001|Reported Event|Prevnar 13|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
11358235|NCT03730961|BG000|Baseline|Sequence 1|"First received placebo (period 1), then received BMS-986231 (period 2) following washout.~Each treatment administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes."
11358236|NCT03730961|BG001|Baseline|Sequence 2|"First received BMS-986231 (period 1), then received placebo (period 2) following washout.~Each treatment administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes."
11358237|NCT03730961|BG002|Baseline|Total|Total of all reporting groups
11358238|NCT03730961|FG000|Participant Flow|Sequence 1|"First received placebo (period 1), then received BMS-986231 (period 2) following washout.~Each treatment administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes."
11358239|NCT03730961|FG001|Participant Flow|Sequence 2|"First received BMS-986231 (period 1), then received placebo (period 2) following washout.~Each treatment administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes."
11358240|NCT03730961|OG000|Outcome|BMS-986231|BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.
11358241|NCT03730961|OG001|Outcome|Placebo|Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.
11358242|NCT03730961|EG000|Reported Event|BMS-986231|BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.
11358243|NCT03730961|EG001|Reported Event|Placebo|Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.
11358244|NCT03730116|BG000|Baseline|the Patients With HT and Concomitant Stable CAD|Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
11358245|NCT03730116|FG000|Participant Flow|the Patients With HT and Concomitant Stable CAD|Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
11358246|NCT03730116|OG000|Outcome|Mean of SBP Changes|Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC
11358247|NCT03730116|OG000|Outcome|the Patients With HT and Concomitant Stable CAD|"Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor~All patients included in the study received a FDC of beta-blocker bisoprolol and ACE inhibitor perindopril. In accordance with the investigation schedule, during the study the investigators collected subjective data from patients on the treatment compliance and tolerability (complaints), performed physical and instrumental examinations, as well as collected data from patients regarding the number of angina attacks and consumption of short-acting nitrates, adverse events/reactions, and assessed their quality of life using the visual analogue scale (VAS)."
11358248|NCT03730116|OG000|Outcome|the Patients With HT and Concomitant Stable CAD|the patients with HT and concomitant stable CAD recieved bisoprolol/perindopril FDC
11358249|NCT03730116|OG000|Outcome|Mean Office DBP Changes Between v3 vs Baseline|mean office DBP changes between v3 vs baseline among patients with HT and CAD recieving biso/perindopril FDC
11358250|NCT03730116|OG000|Outcome|the Patients With HT and Concomitant Stable CAD|Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
11358251|NCT03730116|EG000|Reported Event|the Patients With HT and Concomitant Stable CAD|Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
11358252|NCT03730103|BG000|Baseline|Historical Control Group|The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
11358253|NCT03730103|BG001|Baseline|Same Day Discharge Group|"47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups~Same day discharge: Patients will be discharged home from the hospital on the day of her surgery."
10961871|NCT00863304|EG000|Reported Event|Placebo|Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
10961872|NCT00863304|EG001|Reported Event|Tanezumab 5 mg + Placebo|Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
10961873|NCT00863304|EG002|Reported Event|Tanezumab 10 mg + Placebo|Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
11358254|NCT03730103|BG002|Baseline|Total|Total of all reporting groups
11358255|NCT03730103|FG000|Participant Flow|Historical Control Group|The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
11358256|NCT03730103|FG001|Participant Flow|Same Day Discharge Group|"47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups~Same day discharge: Patients will be discharged home from the hospital on the day of her surgery."
11358257|NCT03730103|OG000|Outcome|Historical Control Group|The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
11358258|NCT03730103|OG001|Outcome|Same Day Discharge Group|"47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups~Same day discharge: Patients will be discharged home from the hospital on the day of her surgery."
11358259|NCT03730103|EG000|Reported Event|Historical Control Group|The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
11358260|NCT03730103|EG001|Reported Event|Same Day Discharge Group|"47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups~Same day discharge: Patients will be discharged home from the hospital on the day of her surgery."
11358261|NCT03729960|BG000|Baseline|LENA|"Lena device with Fitbit and Cocooncam being optional~LENA recorder: The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires"
11358262|NCT03729960|FG000|Participant Flow|LENA|"Lena device with Fitbit and Cocooncam being optional~LENA recorder: The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires"
11358263|NCT03729960|OG000|Outcome|LENA|"Lena device with both Fitbit and Cocooncam being optional~LENA recorder: The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires"
11358264|NCT03729960|OG000|Outcome|LENA|"Lena device with Fitbit and Cocooncam being optional~LENA recorder: The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires"
11358265|NCT03729960|EG000|Reported Event|LENA|"Lena device with Fitbit and Cocooncam being optional~LENA recorder: The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires"
11358266|NCT03729024|BG000|Baseline|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
11358267|NCT03729024|FG000|Participant Flow|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
11358268|NCT03729024|OG000|Outcome|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
11358269|NCT03729024|EG000|Reported Event|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
11358270|NCT03728790|BG000|Baseline|Usual Care|Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
11358271|NCT03728790|BG001|Baseline|Remote Patient Monitoring|"Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.~Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period."
11191678|NCT02132936|EG001|Reported Event|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
11358272|NCT03728790|BG002|Baseline|Total|Total of all reporting groups
11358273|NCT03728790|FG000|Participant Flow|Usual Care|Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
11358274|NCT03728790|FG001|Participant Flow|Remote Patient Monitoring|"Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.~Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period."
11358275|NCT03728790|OG000|Outcome|Usual Care|Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
11236959|NCT02452463|FG000|Participant Flow|Arm I (Nintedanib)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236960|NCT02452463|FG001|Participant Flow|Arm II (Placebo)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236961|NCT02452463|FG002|Participant Flow|Arm III (Nintedanib, Durvalumab)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Nintedanib: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236962|NCT02452463|OG000|Outcome|Arm I (Nintedanib)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236963|NCT02452463|OG001|Outcome|Arm II (Placebo)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236964|NCT02452463|OG002|Outcome|Arm III (Nintedanib, Durvalumab)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Nintedanib: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236965|NCT02452463|EG000|Reported Event|Arm I (Nintedanib)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236966|NCT02452463|EG001|Reported Event|Arm II (Placebo)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236967|NCT02452463|EG002|Reported Event|Arm III (Nintedanib, Durvalumab)|"Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Nintedanib: Given PO~Quality-of-Life Assessment: Ancillary studies"
11236968|NCT02452476|BG000|Baseline|CHF5633|"Single dose within 24 hours from birth.~CHF5633: Rescue treatment (if needed)"
11236969|NCT02452476|BG001|Baseline|Poractant Alfa|"Single dose within 24 hours from birth.~Poractant alfa: Rescue treatment (if needed)"
11236970|NCT02452476|BG002|Baseline|Total|Total of all reporting groups
11236971|NCT02452476|FG000|Participant Flow|CHF5633|"Single dose within 24 hours from birth~CHF5633: Rescue treatment (if needed)"
11236972|NCT02452476|FG001|Participant Flow|Poractant Alfa|"Single dose within 24 hours from birth~Poractant alfa: Rescue treatment (if needed)"
11236973|NCT02452476|OG000|Outcome|CHF5633|"Single dose within 24 hours from birth~CHF5633: Rescue treatment (if needed)"
11236974|NCT02452476|OG001|Outcome|Poractant Alfa|"Single dose within 24 hours from birth~Poractant alfa: Rescue treatment (if needed)"
11236975|NCT02452476|EG000|Reported Event|CHF5633|"Single dose within 24 hours from birth~CHF5633: Rescue treatment (if needed)"
11236976|NCT02452476|EG001|Reported Event|Poractant Alfa|"Single dose within 24 hours from birth~Poractant alfa: Rescue treatment (if needed)"
11236977|NCT02452528|BG000|Baseline|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
11236978|NCT02452528|BG001|Baseline|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
11236979|NCT02452528|BG002|Baseline|Total|Total of all reporting groups
11236980|NCT02452528|FG000|Participant Flow|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
11236981|NCT02452528|FG001|Participant Flow|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
11236982|NCT02452528|OG000|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
11236983|NCT02452528|OG001|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
11236984|NCT02452528|EG000|Reported Event|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
11358276|NCT03728790|OG001|Outcome|Remote Patient Monitoring|"Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.~Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period."
11358277|NCT03728790|EG000|Reported Event|Usual Care|Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
11358278|NCT03728790|EG001|Reported Event|Remote Patient Monitoring|"Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.~Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period."
11358279|NCT03728348|BG000|Baseline|Average Risk Patients|Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multi-target stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.
11358280|NCT03728348|FG000|Participant Flow|Average Risk Patients|Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multitarget stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.
11358281|NCT03728348|OG000|Outcome|Multi-target DNA Test Results|Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multitarget stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.
11358282|NCT03728348|EG000|Reported Event|Average Risk Patients|Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multi-target stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.
11358283|NCT03728140|BG000|Baseline|Self-spent Culture Medium|"Changing embryo transfer solution with self-spent culture medium~Self-spent Culture Medium: Replace embryo transfer solution with Self-spent culture medium in IVF-ET."
11358284|NCT03728140|BG001|Baseline|New Culture Medium|embryo transfer with new culture medium in IVF-ET
11358285|NCT03728140|BG002|Baseline|Total|Total of all reporting groups
11358286|NCT03728140|FG000|Participant Flow|Self-spent Culture Medium|"Changing embryo transfer solution with self-spent culture medium~Self-spent Culture Medium: Replace embryo transfer solution with Self-spent culture medium in IVF-ET."
11358287|NCT03728140|FG001|Participant Flow|New Culture Medium|embryo transfer with new culture medium in IVF-ET
11358288|NCT03728140|OG000|Outcome|Self-spent Culture Medium|"Changing embryo transfer solution with self-spent culture medium~Self-spent Culture Medium: Replace embryo transfer solution with Self-spent culture medium in IVF-ET."
11358289|NCT03728140|OG001|Outcome|New Culture Medium|embryo transfer with new culture medium in IVF-ET
11358290|NCT03728140|EG000|Reported Event|Self-spent Culture Medium|embryo transfer with self-spent culture medium
11358291|NCT03728140|EG001|Reported Event|New Culture Medium|embryo transfer with new culture medium
11358292|NCT03727854|BG000|Baseline|Group1|"Premeal protein enriched bar with dietary modification~Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).~Dietary modification: Subjects in this group will follow diabetes diet education."
11358293|NCT03727854|BG001|Baseline|Group2|"Dietary modification only~Dietary modification: Subjects in this group will follow diabetes diet education."
11358294|NCT03727854|BG002|Baseline|Total|Total of all reporting groups
11358295|NCT03727854|FG000|Participant Flow|Group1|"Premeal protein enriched bar with dietary modification~Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).~Dietary modification: Subjects in this group will follow diabetes diet education."
11358296|NCT03727854|FG001|Participant Flow|Group2|"Dietary modification only~Dietary modification: Subjects in this group will follow diabetes diet education."
11358297|NCT03727854|OG000|Outcome|Group1|"Premeal protein enriched bar with dietary modification~Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).~Dietary modification: Subjects in this group will follow diabetes diet education."
11358298|NCT03727854|OG001|Outcome|Group2|"Dietary modification only~Dietary modification: Subjects in this group will follow diabetes diet education."
11358299|NCT03727854|EG000|Reported Event|Group1|"Premeal protein enriched bar with dietary modification~Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).~Dietary modification: Subjects in this group will follow diabetes diet education."
11358300|NCT03727854|EG001|Reported Event|Group2|"Dietary modification only~Dietary modification: Subjects in this group will follow diabetes diet education."
10961874|NCT00863304|EG003|Reported Event|Naproxen + Placebo|Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
10961875|NCT00863317|BG000|Baseline|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
10961876|NCT00863317|BG001|Baseline|Sucrose|sucrose: table sugar as placebo daily for 14 days
11358301|NCT03727425|BG000|Baseline|Robotic Assisted Bronchoscopy|"Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.~Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions."
11358302|NCT03727425|FG000|Participant Flow|Robotic Assisted Bronchoscopy|"Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.~Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions."
11358303|NCT03727425|OG000|Outcome|Robotic Assisted Bronchoscopy|"Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.~Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions."
11358304|NCT03727425|EG000|Reported Event|Robotic Assisted Bronchoscopy|"Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.~Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions."
11358305|NCT03727347|BG000|Baseline|InSeca Stylus Treatment Group|Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
11358306|NCT03727347|FG000|Participant Flow|InSeca Stylus|Low power radiofrequency treatment of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
11358307|NCT03727347|OG000|Outcome|InSeca Stylus Treatment Group|Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
11358308|NCT03727347|OG000|Outcome|Treatment Group - Baseline|Data collected at baseline from enrolled participants
11358309|NCT03727347|OG001|Outcome|Treatment Group - 2 Week Data|Data collected at 2 weeks post-study procedure
11358310|NCT03727347|OG002|Outcome|Treatment Group - 4 Week Data|Data collected at 4 weeks post-study procedure
11358311|NCT03727347|OG003|Outcome|Treatment Group - 12 Week Data|Data collected at 12 weeks post-study procedure
11358312|NCT03727347|OG004|Outcome|Treatment Group - 26 Week Data|Data collected at 26 weeks post-study procedure
11358313|NCT03727347|OG005|Outcome|Treatment Group - 52 Week Data|Data collected at 52 weeks post-study procedure
11358314|NCT03727347|OG001|Outcome|Treatment Group - 12 Week Data|Data collected at 12 weeks post-study procedure
11358315|NCT03727347|OG002|Outcome|Treatment Group - 26 Week Data|Data collected at 26 weeks post-study procedure
11358316|NCT03727347|OG003|Outcome|Treatment Group - 52 Week Data|Data collected at 52 weeks post-study procedure
11358317|NCT03727347|EG000|Reported Event|InSeca Stylus Treatment Group|Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
11358318|NCT03726996|BG000|Baseline|Children With INAD|"Infantile neuroaxonal dystrophy (INAD) is an extremely rare autosomal recessive neurodegenerative disorder that has grave clinical outcome and significant morbidity and mortality.~Desipramine: Study drug (desipramine) provided in tablet form to be taken daily."
11358319|NCT03726996|FG000|Participant Flow|Children With INAD|"Infantile neuroaxonal dystrophy (INAD) is an extremely rare autosomal recessive neurodegenerative disorder that has grave clinical outcome and significant morbidity and mortality.~Desipramine: Study drug (desipramine) provided in tablet form to be taken daily."
11358320|NCT03726996|OG000|Outcome|Children With INAD|"Infantile neuroaxonal dystrophy (INAD) is an extremely rare autosomal recessive neurodegenerative disorder that has grave clinical outcome and significant morbidity and mortality.~Desipramine: Study drug (desipramine) provided in tablet form to be taken daily."
11358321|NCT03726996|EG000|Reported Event|Children With INAD|"Infantile neuroaxonal dystrophy (INAD) is an extremely rare autosomal recessive neurodegenerative disorder that has grave clinical outcome and significant morbidity and mortality.~Desipramine: Study drug (desipramine) provided in tablet form to be taken daily."
11358322|NCT03726164|BG000|Baseline|Remote Conditioning Group|"Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.~Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times."
11358323|NCT03726164|BG001|Baseline|Control Group|"Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.~Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes."
11358324|NCT03726164|BG002|Baseline|Total|Total of all reporting groups
11358325|NCT03726164|FG000|Participant Flow|Remote Conditioning Group|"Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.~Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times."
11358326|NCT03726164|FG001|Participant Flow|Control Group|"Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.~Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes."
11236985|NCT02452528|EG001|Reported Event|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
11236986|NCT02452762|BG000|Baseline|Enteral Loading Arm|"Vitamin D3 (cholecalciferol) - Single dose at enrolment of 10000 IU/kg of cholecalciferol (max 400000 IU)~Vitamin D3"
11236987|NCT02452762|BG001|Baseline|Placebo Arm|"Patients will receive a placebo solution equivalent in volume to the dose of cholecalciferol administered to patients in the enteral loading arm.~Placebo"
11236988|NCT02452762|BG002|Baseline|Total|Total of all reporting groups
11236989|NCT02452762|FG000|Participant Flow|Enteral Loading Arm|"Vitamin D3 (cholecalciferol) - Single dose at enrolment of 10000 IU/kg of cholecalciferol (max 400000 IU)~Vitamin D3"
11236990|NCT02452762|FG001|Participant Flow|Placebo Arm|"Patients will receive a placebo solution equivalent in volume to the dose of cholecalciferol administered to patients in the enteral loading arm.~Placebo"
11236991|NCT02452762|OG000|Outcome|Enteral Loading Arm|"Vitamin D3 (cholecalciferol) - Single dose at enrolment of 10000 IU/kg of cholecalciferol (max 400000 IU)~Vitamin D3"
11236992|NCT02452762|OG001|Outcome|Placebo Arm|"Patients will receive a placebo solution equivalent in volume to the dose of cholecalciferol administered to patients in the enteral loading arm.~Placebo"
11236993|NCT02452762|OG000|Outcome|Overall Cohort|Includes all randomized participants (both the Enteral Loading Arm and the Placebo Arm)
11236994|NCT02452762|EG000|Reported Event|Enteral Loading Arm|"Vitamin D3 (cholecalciferol) - Single dose at enrolment of 10000 IU/kg of cholecalciferol (max 400000 IU)~Vitamin D3"
11236995|NCT02452762|EG001|Reported Event|Placebo Arm|"Patients will receive a placebo solution equivalent in volume to the dose of cholecalciferol administered to patients in the enteral loading arm.~Placebo"
11236996|NCT02452866|BG000|Baseline|SYM-1219 2g|Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole, for the Treatment of Women and Postmenarchal Adolescent Girls with Bacterial Vaginosis
11236997|NCT02452866|FG000|Participant Flow|SYM-1219|Females 18 & over (not menopausal) with recurring incidences of bacterial vaginosis
11236998|NCT02452866|OG000|Outcome|SYM-1219|SYM-1219 Containing 2 Grams of Secnidazole
11236999|NCT02452866|EG000|Reported Event|SYM-1219 2g|SYM-1219 2g single oral dose
11237000|NCT02452892|BG000|Baseline|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237001|NCT02452892|BG001|Baseline|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237002|NCT02452892|BG002|Baseline|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237003|NCT02452892|BG003|Baseline|LFMS 120 Min|"Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237004|NCT02452892|BG004|Baseline|Total|Total of all reporting groups
11237005|NCT02452892|FG000|Participant Flow|LFMS Sham|For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
11237006|NCT02452892|FG001|Participant Flow|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2, subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation."
11237007|NCT02452892|FG002|Participant Flow|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~Week 1: Subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation."
11341526|NCT03683719|BG003|Baseline|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341527|NCT03683719|BG004|Baseline|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 16 weeks.~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11341528|NCT03683719|BG005|Baseline|Total|Total of all reporting groups
10961877|NCT00863317|BG002|Baseline|Total|Total of all reporting groups
11185533|NCT02094937|OG000|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11185534|NCT02094937|OG001|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11185535|NCT02094937|OG002|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11358327|NCT03726164|OG000|Outcome|Remote Conditioning Group|"Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.~Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times."
11358328|NCT03726164|OG001|Outcome|Control Group|"Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.~Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes."
11358329|NCT03726164|EG000|Reported Event|Remote Conditioning Group|"Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.~Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times."
11358330|NCT03726164|EG001|Reported Event|Control Group|"Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.~Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes."
11358331|NCT03725852|BG000|Baseline|GLPG1205 100 mg|Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
11185536|NCT02094937|EG000|Reported Event|FF/VI 100/25 mcg OD Period 1|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
11358332|NCT03725852|BG001|Baseline|Placebo|Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
11358333|NCT03725852|BG002|Baseline|Total|Total of all reporting groups
11358334|NCT03725852|FG000|Participant Flow|GLPG1205 100 mg|Participants received GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
11358335|NCT03725852|FG001|Participant Flow|Placebo|Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
11358336|NCT03725852|OG000|Outcome|GLPG1205 100 mg|Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
11358337|NCT03725852|OG001|Outcome|Placebo|Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
11358338|NCT03725852|EG000|Reported Event|GLPG1205 100 mg|Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
11358339|NCT03725852|EG001|Reported Event|Placebo|Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
11358340|NCT03725722|BG000|Baseline|Delgocitinib Cream 1 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358341|NCT03725722|BG001|Baseline|Delgocitinib Cream 3 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358342|NCT03725722|BG002|Baseline|Delgocitinib Cream 8 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358343|NCT03725722|BG003|Baseline|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
10961878|NCT00863317|FG000|Participant Flow|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
10961879|NCT00863317|FG001|Participant Flow|Placebo|sucrose: table sugar as placebo daily for 14 days
10961880|NCT00863317|OG000|Outcome|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
10961881|NCT00863317|OG001|Outcome|Placebo|sucrose: table sugar as placebo daily for 14 days
11185537|NCT02094937|EG001|Reported Event|FF 100 mcg OD Period 2|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11185538|NCT02094937|EG002|Reported Event|FP 100 mcg BD Period 2|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11237008|NCT02452892|FG003|Participant Flow|LFMS 120 Min|"Week 2: Subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation."
11237009|NCT02452892|OG000|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237010|NCT02452892|OG001|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237011|NCT02452892|OG002|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237012|NCT02452892|OG001|Outcome|LFMS 120 Min|"Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237013|NCT02452892|OG000|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237014|NCT02452892|OG001|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237015|NCT02452892|OG002|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237016|NCT02452892|EG000|Reported Event|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237017|NCT02452892|EG001|Reported Event|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237018|NCT02452892|EG002|Reported Event|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237019|NCT02452892|EG003|Reported Event|LFMS 120 Min - Week 2|"Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
11237020|NCT02452931|BG000|Baseline|Assigned Intervention|"Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.~Leuprolide Acetate 45 mg: Subcutaneous injection"
11237021|NCT02452931|FG000|Participant Flow|Assigned Intervention|"Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.~Leuprolide Acetate 45 mg: Subcutaneous injection"
11237022|NCT02452931|OG000|Outcome|Assigned Intervention|"Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.~Leuprolide Acetate 45 mg: Subcutaneous injection"
11237023|NCT02452931|EG000|Reported Event|Assigned Intervention|"Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.~Leuprolide Acetate 45 mg: Subcutaneous injection"
11237024|NCT02452944|BG000|Baseline|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'."
11237025|NCT02452944|BG001|Baseline|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics was injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
11237026|NCT02452944|BG002|Baseline|Total|Total of all reporting groups
11237027|NCT02452944|FG000|Participant Flow|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis muscles. 10mL of local anesthetics (LA; 1.5% lidocaine + epi 1:200,000) were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator for confirming the block. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'."
11237028|NCT02452944|FG001|Participant Flow|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group)~The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics (LA;1.5% lidocaine + epi 1:200,000) were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected."
11237029|NCT02452944|OG000|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerv"
11237030|NCT02452944|OG001|Outcome|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided m"
11237031|NCT02452944|OG000|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
11237032|NCT02452944|OG001|Outcome|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
11237033|NCT02452944|EG000|Reported Event|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
11237034|NCT02452944|EG001|Reported Event|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
11237035|NCT02453048|BG000|Baseline|Placebo|"Individuals will be vaccinated once intranasally with the designated dose of Placebo at a Dose 2 x 0.4 mL (0.4 mL per nostril).~Placebo: Diluent"
11237036|NCT02453048|BG001|Baseline|BPZE1 - 10,000,000 Cfu|"Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).~BPZE1: Intranasal live, attenuated vaccine"
11237037|NCT02453048|BG002|Baseline|BPZE1 - 100,000,000 Cfu|"Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).~BPZE1: Intranasal live, attenuated vaccine"
11237038|NCT02453048|BG003|Baseline|BPZE1 - 1,000,000,000 Cfu|"Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).~BPZE1: Intranasal live, attenuated vaccine"
11237039|NCT02453048|BG004|Baseline|BPZE1 - High Antibody 1,000,000,000 Cfu|"Individuals with high baseline antibodies will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).~BPZE1: Intranasal live, attenuated vaccine"
11237040|NCT02453048|BG005|Baseline|Total|Total of all reporting groups
11237041|NCT02453048|FG000|Participant Flow|Placebo|"Individuals will be vaccinated once intranasally with the designated dose of Placebo at a Dose 2 x 0.4 mL (0.4 mL per nostril).~Placebo: Diluent"
11237042|NCT02453048|FG001|Participant Flow|BPZE1 - 10,000,000 Cfu|"Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).~BPZE1: Intranasal live, attenuated vaccine"
11237043|NCT02453048|FG002|Participant Flow|BPZE1 - 100,000,000 Cfu|"Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).~BPZE1: Intranasal live, attenuated vaccine"
11237044|NCT02453048|FG003|Participant Flow|BPZE1 - 1,000,000,000 Cfu|"Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).~BPZE1: Intranasal live, attenuated vaccine"
11237045|NCT02453048|FG004|Participant Flow|BPZE1 - High Antibody 1,000,000,000 Cfu|"Individuals with high baseline antibodies will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).~BPZE1: Intranasal live, attenuated vaccine"
11237046|NCT02453048|OG000|Outcome|Placebo|Subjects receiving intranasal Placebo
11237047|NCT02453048|OG001|Outcome|Low Dose Group|Subjects receiving 10^7 CFU of intranasal BPZE1
11237048|NCT02453048|OG002|Outcome|Medium Dose Group|Subjects receiving 10^8 CFU of intranasal BPZE1
11358344|NCT03725722|BG004|Baseline|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 8 weeks~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11358345|NCT03725722|BG005|Baseline|Total|Total of all reporting groups
11237049|NCT02453048|OG003|Outcome|High Dose Group|Subjects receiving 10^9 CFU of intranasal BPZE1
11237050|NCT02453048|OG004|Outcome|PRN High Group|Subjects with a pre-existing baseline PRN > 20 IU that received 10^9 CFU of intranasal BPZE1 (non-randomized group)
11237051|NCT02453048|EG000|Reported Event|Placebo|Subjects receiving intranasal Placebo
11237052|NCT02453048|EG001|Reported Event|Low Dose Group|Subjects receiving 10^7 CFU of intranasal BPZE1
11237053|NCT02453048|EG002|Reported Event|Medium Dose Group|Subjects receiving 10^8 CFU of intranasal BPZE1
11237054|NCT02453048|EG003|Reported Event|High Dose Group|Subjects receiving 10^9 CFU of intranasal BPZE1
11237055|NCT02453048|EG004|Reported Event|PRN High Group|Subjects with a pre-existing baseline PRN > 20 IU that received 10^9 CFU of intranasal BPZE1 (non-randomized group)
11237056|NCT02453113|BG000|Baseline|Low Power Laser|"Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment~low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment"
11237057|NCT02453113|FG000|Participant Flow|Low Power Laser|"Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment~low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment"
11237058|NCT02453113|OG000|Outcome|Low Power Laser|"Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment~low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment"
11237059|NCT02453113|EG000|Reported Event|Low Power Laser|"Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment~low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment"
11237060|NCT02453191|BG000|Baseline|Treatment|"talimogene laherparepvec in combination with radiotherapy~talimogene laherparepvec: talimogene laherparepvec~Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines."
10961882|NCT00863317|EG000|Reported Event|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
11358346|NCT03725722|FG000|Participant Flow|Delgocitinib Cream 1 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358347|NCT03725722|FG001|Participant Flow|Delgocitinib Cream 3 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358348|NCT03725722|FG002|Participant Flow|Delgocitinib Cream 8 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358349|NCT03725722|FG003|Participant Flow|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358350|NCT03725722|FG004|Participant Flow|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 8 weeks~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11358351|NCT03725722|OG000|Outcome|Delgocitinib Cream 1 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358352|NCT03725722|OG001|Outcome|Delgocitinib Cream 3 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358353|NCT03725722|OG002|Outcome|Delgocitinib Cream 8 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358354|NCT03725722|OG003|Outcome|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358355|NCT03725722|OG004|Outcome|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 8 weeks~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11358356|NCT03725722|EG000|Reported Event|Delgocitinib Cream 1 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358357|NCT03725722|EG001|Reported Event|Delgocitinib Cream 3 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358358|NCT03725722|EG002|Reported Event|Delgocitinib Cream 8 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358359|NCT03725722|EG003|Reported Event|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 8 weeks~Delgocitinib cream: Cream for topical application"
11358360|NCT03725722|EG004|Reported Event|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 8 weeks~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11358361|NCT03725098|BG000|Baseline|HEMOBLAST Bellows (Hemostatic Device)|"Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use~HEMOBLAST Bellows: The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures."
11358362|NCT03725098|BG001|Baseline|FLOSEAL (Hemostatic Device)|"Bleeding sites will be treated with FLOSEAL per its approved Indications for Use~FLOSEAL: The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical."
11358363|NCT03725098|BG002|Baseline|Total|Total of all reporting groups
11358364|NCT03725098|FG000|Participant Flow|HEMOBLAST Bellows (Hemostatic Device)|"Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use~HEMOBLAST Bellows: The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures."
11358365|NCT03725098|FG001|Participant Flow|FLOSEAL (Hemostatic Device)|"Bleeding sites will be treated with FLOSEAL per its approved Indications for Use~FLOSEAL: The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical."
11358366|NCT03725098|OG000|Outcome|HEMOBLAST Bellows (Hemostatic Device)|"Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use~HEMOBLAST Bellows: The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures."
11358367|NCT03725098|OG001|Outcome|FLOSEAL (Hemostatic Device)|"Bleeding sites will be treated with FLOSEAL per its approved Indications for Use~FLOSEAL: The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical."
11358368|NCT03725098|EG000|Reported Event|HEMOBLAST Bellows (Hemostatic Device)|"Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use~HEMOBLAST Bellows: The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures."
11237061|NCT02453191|FG000|Participant Flow|Treatment|"talimogene laherparepvec in combination with radiotherapy~talimogene laherparepvec: talimogene laherparepvec~Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines."
11237062|NCT02453191|OG000|Outcome|Treatment|"talimogene laherparepvec in combination with radiotherapy~talimogene laherparepvec: talimogene laherparepvec~Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines."
11237063|NCT02453191|EG000|Reported Event|Treatment|"talimogene laherparepvec in combination with radiotherapy~talimogene laherparepvec: talimogene laherparepvec~Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines."
11237064|NCT02453256|BG000|Baseline|Double-Blind Placebo, Then Tocilizumab Open Label|Participants received double-blind matching placebo from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96.
11237065|NCT02453256|BG001|Baseline|Double-Blind Tocilizumab, Then Tocilizumab Open Label|Participants received double-blind tocilizumab from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96.
11237066|NCT02453256|BG002|Baseline|Total|Total of all reporting groups
11237067|NCT02453256|FG000|Participant Flow|Double-Blind Placebo, Then Open Label Tocilizumab|Participants received double-blind matching placebo from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96.
11237068|NCT02453256|FG001|Participant Flow|Double-Blind Tocilizumab, Then Open Label Tocilizumab|Participants received double-blind tocilizumab from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96.
11237069|NCT02453256|OG000|Outcome|Double-Blind Placebo|Participants received double-blind matching placebo from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96.
11237070|NCT02453256|OG001|Outcome|Double-Blind Tocilizumab|Participants received double-blind tocilizumab from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96.
11237071|NCT02453256|OG000|Outcome|Double-Blind Tocilizumab|Participants received double-blind tocilizumab from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96.
11237072|NCT02453256|OG002|Outcome|Placebo, Then Tocilizumab Open Label|Participants who received placebo during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96.
11237073|NCT02453256|OG003|Outcome|Tocilizumab, Then Tocilizumab Open Label|Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96.
11237074|NCT02453256|OG000|Outcome|Tocilizumab, Then Tocilizumab Open Label|Participants who received tocilizumab during the double blind period from Baseline to Week 47, received tocilizumab from Week 48 to Week 96.
11237075|NCT02453256|OG000|Outcome|Double-Blind Tocilizumab, Then Open Label Tocilizumab|Participants received double-blind tocilizumab from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96.
11237076|NCT02453256|EG000|Reported Event|Double-Blind Placebo|Participants received double-blind matching placebo from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96.
11237077|NCT02453256|EG001|Reported Event|Double-Blind Tocilizumab|Participants received double-blind tocilizumab from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96.
11237078|NCT02453256|EG002|Reported Event|Placebo, Then Tocilizumab Open Label|Participants who received placebo during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96.
11237079|NCT02453256|EG003|Reported Event|Tocilizumab, Then Tocilizumab Open Label|Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96.
11237080|NCT02453282|BG000|Baseline|Durvalumab Monotherapy|Participants received durvalumab 20 mg/kg IV infusion Q4W until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11237081|NCT02453282|BG001|Baseline|Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued on durvalumab 20 mg/kg Q4W, starting on Week 16 until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11237082|NCT02453282|BG002|Baseline|SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until worsening of disease under investigation, unless specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous tumors only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous tumors only; pemetrexed maintenance dose was permitted)."
11237083|NCT02453282|BG003|Baseline|Total|Total of all reporting groups
11237084|NCT02453282|FG000|Participant Flow|Durvalumab Monotherapy|Participants received durvalumab 20 milligram per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks (Q4W) until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11237085|NCT02453282|FG001|Participant Flow|Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued on durvalumab 20 mg/kg Q4W, starting on Week 16 until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11341529|NCT03683719|FG000|Participant Flow|Delgocitinib Cream 1 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341530|NCT03683719|FG001|Participant Flow|Delgocitinib Cream 3 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11237086|NCT02453282|FG002|Participant Flow|SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until worsening of disease under investigation, unless specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/square meter (m^2) and carboplatin area under the plasma drug concentration-time curve (AUC) 5 or 6 mg*minute per milliliter (mg*min/mL).~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous tumors only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous tumors only; pemetrexed maintenance dose was permitted)."
11237087|NCT02453282|OG000|Outcome|Durvalumab Monotherapy|Participants received durvalumab 20 mg/kg IV infusion Q4W until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11237088|NCT02453282|OG001|Outcome|Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued on durvalumab 20 mg/kg Q4W, starting on Week 16 until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11237089|NCT02453282|OG002|Outcome|SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until worsening of disease under investigation, unless specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous tumors only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous tumors only; pemetrexed maintenance dose was permitted)."
11237090|NCT02453282|OG000|Outcome|Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued on durvalumab 20 mg/kg Q4W, starting on Week 16 until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11237091|NCT02453282|OG001|Outcome|SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until worsening of disease under investigation, unless specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous tumors only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous tumors only; pemetrexed maintenance dose was permitted)."
11237092|NCT02453282|EG000|Reported Event|Durvalumab Monotherapy|Participants received durvalumab 20 mg/kg IV infusion Q4W until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11237093|NCT02453282|EG001|Reported Event|Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued on durvalumab 20 mg/kg Q4W, starting on Week 16 until worsening of the disease under investigation, unless specific treatment discontinuation criteria were met.
11237094|NCT02453282|EG002|Reported Event|SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until worsening of disease under investigation, unless specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of Gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous tumors only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous tumors only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous tumors only; pemetrexed maintenance dose was permitted)."
11237095|NCT02453321|BG000|Baseline|Cont. Femoral Block - Low Dose Group|"Arm is named by the intervention received... Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease intended to block the sensory nerves to decrease pain in the knee after TKA.~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It is only dosed postoperatively after verifying sciatic nerve function is intact. The infusion is 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the infusions of bupivacaine in peripheral nerve catheters will be 0.0625% for the femoral and adductor canal, and"
11337725|NCT03592745|FG001|Participant Flow|Sham tVNS + Robotic Arm Therapy|"Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.~Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control."
10961883|NCT00863317|EG001|Reported Event|Placebo|sucrose: table sugar as placebo daily for 14 days
10961884|NCT00863343|BG000|Baseline|Participants w/ Disease|Positive for Flu A by reference test
11185539|NCT02094937|EG003|Reported Event|FP 250 mcg BD Period 2|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
11185540|NCT02095106|BG000|Baseline|Traditional Cast First|"Patients in this group first received a traditional fiberglass cast for two weeks, after which this cast was removed and a waterproof cast applied.~Waterproof Cast~Traditional cast"
11185541|NCT02095106|BG001|Baseline|Waterproof Cast First|"Patients in this group received a waterproof cast for 2 weeks, after which the waterproof cast was removed and a traditional fiberglass cast applied for an additional two weeks.~Waterproof Cast~Traditional cast"
11185542|NCT02095106|BG002|Baseline|Total|Total of all reporting groups
11185543|NCT02095106|FG000|Participant Flow|Traditional Cast First|"Patients in this group first received a traditional fiberglass cast for two weeks, after which this cast was removed and a waterproof cast applied.~Waterproof Cast~Traditional cast"
11185544|NCT02095106|FG001|Participant Flow|Waterproof Cast First|"Patients in this group received a waterproof cast for 2 weeks, after which the waterproof cast was removed and a traditional fiberglass cast applied for an additional two weeks.~Waterproof Cast~Traditional cast"
11185545|NCT02095106|OG000|Outcome|Traditional Cast|Patients in this group were assessed after wearing the traditional cast for 2 weeks, as their first or second intervention.
11185546|NCT02095106|OG001|Outcome|Waterproof Cast|Patients in this group were assessed after wearing a waterproof cast for 2 weeks, as the first or second intervention type.
11185547|NCT02095106|OG000|Outcome|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks as the first or second study intervention
11185548|NCT02095106|OG001|Outcome|Waterproof Cast First|Patients in this group received a waterproof cast for 2 weeks, as the first or second study intervention.
11185549|NCT02095106|OG000|Outcome|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks, as the first or second study intervention.
11185550|NCT02095106|OG001|Outcome|Waterproof Cast|Patients in this group received a waterproof cast for 2 weeks, as the first or second study intervention.
11185551|NCT02095106|EG000|Reported Event|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks, as the first or second study intervention
11185552|NCT02095106|EG001|Reported Event|Waterproof Cast|Patients in this group receives a waterproof cast for 2 weeks, as the first or second study intervention
11185553|NCT02095145|BG000|Baseline|Group I (Pomegranate-extract Pill)|"Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Pomegranate-Extract Pill: Given PO"
11185554|NCT02095145|BG001|Baseline|Group II (Placebo)|"Patients receive placebo PO QD for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11185555|NCT02095145|BG002|Baseline|Total|Total of all reporting groups
11185556|NCT02095145|FG000|Participant Flow|Group I (Pomegranate-extract Pill)|"Patients receive pomegranate-extract pill orally once a day for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Pomegranate-Extract Pill: Given PO"
11185557|NCT02095145|FG001|Participant Flow|Group II (Placebo)|"Patients receive placebo orally once a day for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11185558|NCT02095145|OG000|Outcome|Group I (Pomegranate-extract Pill)|"Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Pomegranate-Extract Pill: Given PO"
11185559|NCT02095145|OG001|Outcome|Group II (Placebo)|"Patients receive placebo PO QD for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11185560|NCT02095145|OG000|Outcome|Group I (Pomegranate-extract Pill)|"Patients receive pomegranate-extract pill orally once a day for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Pomegranate-Extract Pill: Given PO"
11185561|NCT02095145|OG001|Outcome|Group II (Placebo)|"Patients receive placebo orally once a day for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11185562|NCT02095145|EG000|Reported Event|Group I (Pomegranate-extract Pill)|"Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Pomegranate-Extract Pill: Given PO"
11185563|NCT02095145|EG001|Reported Event|Group II (Placebo)|"Patients receive placebo PO QD for 52 weeks (+/- 1 week).~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11185564|NCT02095158|BG000|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
11185565|NCT02095158|FG000|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
11185566|NCT02095158|OG000|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
11185567|NCT02095158|EG000|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
11185568|NCT02095197|BG000|Baseline|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
11185569|NCT02095197|BG001|Baseline|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
11185570|NCT02095197|BG002|Baseline|Total|Total of all reporting groups
10961885|NCT00863343|BG001|Baseline|Participants w/o Disease|Participants without Flu A by reference method
11358369|NCT03725098|EG001|Reported Event|FLOSEAL (Hemostatic Device)|"Bleeding sites will be treated with FLOSEAL per its approved Indications for Use~FLOSEAL: The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical."
11358370|NCT03725085|BG000|Baseline|Mucinex™|Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
11358371|NCT03725085|FG000|Participant Flow|Mucinex™|Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
11358372|NCT03725085|OG000|Outcome|Mucinex™|Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
11358373|NCT03725085|OG000|Outcome|Mucinex™|Subjects received a twice daily dose of Mucinex™ 600mg Guaifenesin extended-release bi-layer tablets every 12hours
11358374|NCT03725085|EG000|Reported Event|Mucinex™|Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
11358375|NCT03725033|BG000|Baseline|Subetta|"Oral administration. 2 tablets 2 times a day 15 minutes before meals. Keep the tablets in your mouth, not swallowing, until completely they are dissolved.~Subetta: For oral use."
11358376|NCT03725033|BG001|Baseline|Placebo|"Oral administration. 2 tablets 2 times a day 15 minutes before meals. Keep the tablets in your mouth, not swallowing, until completely they are dissolved.~Placebo: For oral use."
11358377|NCT03725033|BG002|Baseline|Total|Total of all reporting groups
11358378|NCT03725033|FG000|Participant Flow|Subetta|Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
11358379|NCT03725033|FG001|Participant Flow|Placebo|Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
11358380|NCT03725033|OG000|Outcome|Subetta|"Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.~Subetta: Oral administration."
11358381|NCT03725033|OG001|Outcome|Placebo|"Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.~Placebo: Oral administration."
11358382|NCT03725033|OG000|Outcome|Subetta|Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
11358383|NCT03725033|OG001|Outcome|Placebo|Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
11358384|NCT03725033|EG000|Reported Event|Subetta|Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
11358385|NCT03725033|EG001|Reported Event|Placebo|Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
11358386|NCT03724981|BG000|Baseline|Overall|Participants were randomized to one of two treatment sequences: dulaglutide injection device to semaglutide injection device or semaglutide injection device to dulaglutide injection device.
11358387|NCT03724981|FG000|Participant Flow|Dulaglutide to Semaglutide|Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad.
11358388|NCT03724981|FG001|Participant Flow|Semaglutide to Dulaglutide|Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad.
11358389|NCT03724981|OG000|Outcome|Dulaglutide to Semaglutide|Injection of commercial dulaglutide pen on a practice pad, then injection of semaglutide on a practice pad.
11358390|NCT03724981|OG001|Outcome|Semaglutide to Dulaglutide|Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide on a practice pad.
11358391|NCT03724981|OG000|Outcome|Dulaglutide to Semaglutide|Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad.
11358392|NCT03724981|OG001|Outcome|Semaglutide to Dulaglutide|Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad.
11358393|NCT03724981|EG000|Reported Event|Dulaglutide|Injection of commercial dulaglutide pen on a practice pad.
11358394|NCT03724981|EG001|Reported Event|Semaglutide|Injection of commercial semaglutide pen on a practice pad.
11358395|NCT03724968|BG000|Baseline|Arm A|"Nivolumab and Relatlimab~Nivolumab: Nivolumab will be given by vein on day 1 of each cycle.~Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle"
11358396|NCT03724968|BG001|Baseline|Arm B|"Nivolumab and Ipilimumab~Nivolumab: Nivolumab will be given by vein on day 1 of each cycle.~Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days)."
11358397|NCT03724968|BG002|Baseline|Total|Total of all reporting groups
11358398|NCT03724968|FG000|Participant Flow|Arm A|"Nivolumab and Relatlimab~Nivolumab: Nivolumab will be given by vein on day 1 of each cycle.~Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle"
11358399|NCT03724968|FG001|Participant Flow|Arm B|"Nivolumab and Ipilimumab~Nivolumab: Nivolumab will be given by vein on day 1 of each cycle.~Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days)."
11358400|NCT03724968|OG000|Outcome|Arm A|"Nivolumab and Relatlimab~Nivolumab: Nivolumab will be given by vein on day 1 of each cycle.~Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle"
11358401|NCT03724968|OG001|Outcome|Arm B|"Nivolumab and Ipilimumab~Nivolumab: Nivolumab will be given by vein on day 1 of each cycle.~Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days)."
11358402|NCT03724968|EG000|Reported Event|Arm A|"Nivolumab and Relatlimab~Nivolumab: Nivolumab will be given by vein on day 1 of each cycle.~Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle"
11358403|NCT03724968|EG001|Reported Event|Arm B|"Nivolumab and Ipilimumab~Nivolumab: Nivolumab will be given by vein on day 1 of each cycle.~Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days)."
11185571|NCT02095197|FG000|Participant Flow|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
11185572|NCT02095197|FG001|Participant Flow|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
11185573|NCT02095197|OG000|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
11185574|NCT02095197|OG001|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
11185575|NCT02095197|EG000|Reported Event|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
11185576|NCT02095197|EG001|Reported Event|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
11185577|NCT02095223|BG000|Baseline|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
11185578|NCT02095223|BG001|Baseline|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
11185579|NCT02095223|BG002|Baseline|Total|Total of all reporting groups
11185580|NCT02095223|FG000|Participant Flow|Electromyographic Biofeedback Group|"Participants in the electromyographic biofeedback supplemented exercise will be instructed on correct setup and use of the electromyographic biofeedback unit. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group. Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest."
11185581|NCT02095223|FG001|Participant Flow|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
11185582|NCT02095223|OG000|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
11185583|NCT02095223|OG001|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
11191679|NCT02132936|EG002|Reported Event|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
11185584|NCT02095223|EG000|Reported Event|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
11185585|NCT02095223|EG001|Reported Event|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
11185586|NCT02095340|BG000|Baseline|Positive Training|Positive Interpretation Bias Training
11185587|NCT02095340|BG001|Baseline|Neutral Training|Neutral Interpretation Bias Training
11185588|NCT02095340|BG002|Baseline|Child Interpretation Biases Assessment|All children, regardless of whether the parent was assigned to either the positive or neutral training condition, completed a single assessment of interpretation biases.
11185589|NCT02095340|BG003|Baseline|Total|Total of all reporting groups
11185590|NCT02095340|FG000|Participant Flow|Positive Training|Positive Interpretation Bias Training
11185591|NCT02095340|FG001|Participant Flow|Neutral Training|Neutral Interpretation Bias Training
11185592|NCT02095340|FG002|Participant Flow|Child Interpretation Biases Assessment|All children, regardless of whether the parent was assigned to either the positive or neutral training condition, completed a single assessment of interpretation biases.
11185593|NCT02095340|OG000|Outcome|Positive Training|Positive Interpretation Bias Training
11185594|NCT02095340|OG001|Outcome|Neutral Training|Neutral Interpretation Bias Training
11185595|NCT02095340|OG002|Outcome|Child Interpretation Biases Assessment|All children completed a Child Interpretation Biases Assessment once.
11185596|NCT02095340|OG002|Outcome|Child Interpretation Biases Assessment|Child Interpretation Biases Assessment
11185597|NCT02095340|EG000|Reported Event|Positive Training|Positive Interpretation Bias Training
11185598|NCT02095340|EG001|Reported Event|Neutral Training|Neutral Interpretation Bias Training
11185599|NCT02095340|EG002|Reported Event|Child Interpretation Biases Assessment|Child Interpretation Biases Assessment
11185600|NCT02095535|BG000|Baseline|Study Group|"All study participants~Chlorhexidine gluconate: antiseptic"
11185601|NCT02095535|FG000|Participant Flow|Study Group|"All study participants~Chlorhexidine gluconate: antiseptic"
11185602|NCT02095535|OG000|Outcome|Study Group|"All study participants~Chlorhexidine gluconate: antiseptic"
11185603|NCT02095535|EG000|Reported Event|Study Group|"All study participants~Chlorhexidine gluconate: antiseptic"
11185604|NCT02095561|BG000|Baseline|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
11185605|NCT02095561|BG001|Baseline|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
11185606|NCT02095561|BG002|Baseline|Total|Total of all reporting groups
11185607|NCT02095561|FG000|Participant Flow|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
11185608|NCT02095561|FG001|Participant Flow|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
11185609|NCT02095561|OG000|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
11185610|NCT02095561|OG001|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
11185611|NCT02095561|EG000|Reported Event|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
11185612|NCT02095561|EG001|Reported Event|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
11191680|NCT02132936|EG003|Reported Event|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks~Gel vehicle"
11358404|NCT03724877|BG000|Baseline|LABA-LAMA-ICS|The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
11358405|NCT03724877|BG001|Baseline|LABA-LAMA|The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
11358406|NCT03724877|BG002|Baseline|Total|Total of all reporting groups
11358407|NCT03724877|FG000|Participant Flow|LABA-LAMA-ICS|The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
11358408|NCT03724877|FG001|Participant Flow|LABA-LAMA|The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
11358409|NCT03724877|OG000|Outcome|LABA-LAMA-ICS|The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
11358410|NCT03724877|OG001|Outcome|LABA-LAMA|The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
11358411|NCT03724877|EG000|Reported Event|LABA-LAMA-ICS|The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
11358412|NCT03724877|EG001|Reported Event|LABA-LAMA|The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
11358413|NCT03724253|BG000|Baseline|Breast|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358414|NCT03724253|BG001|Baseline|Prostate|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358415|NCT03724253|BG002|Baseline|Colorectal|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358416|NCT03724253|BG003|Baseline|Non-Small Cell Lung Cancer (NSCLC)|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358417|NCT03724253|BG004|Baseline|Small-Cell Lung Cancer (SCLC)|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358418|NCT03724253|BG005|Baseline|Total|Total of all reporting groups
11358419|NCT03724253|FG000|Participant Flow|Breast|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358420|NCT03724253|FG001|Participant Flow|Prostate|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358421|NCT03724253|FG002|Participant Flow|Colorectal|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358422|NCT03724253|FG003|Participant Flow|Non-Small Cell Lung Cancer (NSCLC)|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358423|NCT03724253|FG004|Participant Flow|Small-Cell Lung Cancer (SCLC)|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358424|NCT03724253|OG000|Outcome|Breast|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358425|NCT03724253|OG001|Outcome|Prostate|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358426|NCT03724253|OG002|Outcome|Colorectal|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358427|NCT03724253|OG003|Outcome|Non-Small Cell Lung Cancer (NSCLC)|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358428|NCT03724253|OG004|Outcome|Small-Cell Lung Cancer (SCLC)|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358429|NCT03724253|EG000|Reported Event|Breast|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358430|NCT03724253|EG001|Reported Event|Prostate|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358431|NCT03724253|EG002|Reported Event|Colorectal|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358432|NCT03724253|EG003|Reported Event|Non-Small Cell Lung Cancer (NSCLC)|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358433|NCT03724253|EG004|Reported Event|Small-Cell Lung Cancer (SCLC)|All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
11358434|NCT03723980|BG000|Baseline|Control Group or Group I or Calcium Hydroxide Group|Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
11358435|NCT03723980|BG001|Baseline|Experimental Group or Group II or Propolis Group|Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
11358436|NCT03723980|BG002|Baseline|Total|Total of all reporting groups
11358437|NCT03723980|FG000|Participant Flow|Control Group or Group I or Calcium Hydroxide Group|Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
11358438|NCT03723980|FG001|Participant Flow|Experimental Group or Group II or Propolis Group|Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
11358439|NCT03723980|OG000|Outcome|Control Group or Group I or Calcium Hydroxide Group|Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
11358440|NCT03723980|OG001|Outcome|Experimental Group or Group II or Propolis Group|Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
11358441|NCT03723980|OG000|Outcome|Pain Experienced by Males|Irrespective of the medicament inserted; Pain severity based of Visual analogue scale is analyzed both quantitatively and qualitatively in males.
11358442|NCT03723980|OG001|Outcome|Pain Experienced by Females|Irrespective of the medicament inserted; Pain severity based of Visual analogue scale is analyzed both quantitatively and qualitatively in females.
11358443|NCT03723980|OG000|Outcome|Age Group; 20 to 24|"For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40~This age group consisted of total number of 6 patients. 3 belonged to control group and 3 belonged to experimental group"
11358444|NCT03723980|OG001|Outcome|Age Group; 25 to 29|"For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40~This age group consisted of total number of 10 patients. 6 belonged to control group and 4 belonged to experimental group"
11358445|NCT03723980|OG002|Outcome|Age Group; 30 to 34|"For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40~This age group consisted of total number of 17 patients. 6 belonged to control group and 11 belonged to experimental group"
10961886|NCT00863343|BG002|Baseline|Total|Total of all reporting groups
10961887|NCT00863343|FG000|Participant Flow|Participants w/ Disease|Positive for Flu A by reference test
11358446|NCT03723980|OG003|Outcome|Age Group; 35 to 40|"For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40~This age group consisted of total number of 35 patients. 18 belonged to control group and 17 belonged to experimental group"
11358447|NCT03723980|EG000|Reported Event|Control Group or Group I or Calcium Hydroxide Group|Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
10961888|NCT00863343|FG001|Participant Flow|Participants w/o Disease|Participants without Flu A by reference method
10961889|NCT00863343|OG000|Outcome|Participants w/ Disease|Positive for Flu A by reference test
11341531|NCT03683719|FG002|Participant Flow|Delgocitinib Cream 8 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341532|NCT03683719|FG003|Participant Flow|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341533|NCT03683719|FG004|Participant Flow|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 16 weeks.~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11341534|NCT03683719|OG000|Outcome|Delgocitinib Cream 1 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341535|NCT03683719|OG001|Outcome|Delgocitinib Cream 3 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
10961890|NCT00863343|OG001|Outcome|Participants w/o Disease|Participants without Flu A by reference method
10961891|NCT00863343|OG000|Outcome|Participants w/ Disease|Positive for Flu B by reference test
10961892|NCT00863343|OG001|Outcome|Participants w/o Disease|Participants without Flu B by reference method
10961893|NCT00863343|EG000|Reported Event|Participants With Disease|Positive for Flu by reference test
10961894|NCT00863343|EG001|Reported Event|Participants w/o Disease|Participants without Flu by reference method
11341536|NCT03683719|OG002|Outcome|Delgocitinib Cream 8 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341537|NCT03683719|OG003|Outcome|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341538|NCT03683719|OG004|Outcome|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 16 weeks.~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11341539|NCT03683719|EG000|Reported Event|Delgocitinib Cream 1 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341540|NCT03683719|EG001|Reported Event|Delgocitinib Cream 3 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341541|NCT03683719|EG002|Reported Event|Delgocitinib Cream 8 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341542|NCT03683719|EG003|Reported Event|Delgocitinib Cream 20 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11341543|NCT03683719|EG004|Reported Event|Delgocitinib Cream Vehicle|"Delgocitinib cream vehicle applied twice daily for 16 weeks.~Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient."
11341544|NCT03683758|BG000|Baseline|FIFA11+ / Intervention Group|"This group will complete the FIFA11+ warm-up three times per week for eight weeks.~FIFA11+: The FIFA11+ has three parts and consist of 15 exercises.~Part 1 consists of active stretching, running and controlled partner contact drills.~Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups.~Part 3 consists of higher intensity running drills, compared to those covered in Part 1.~Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential."
11341545|NCT03683758|BG001|Baseline|Typical Warm-up / Control Group|"This group will complete their usual warm-up three times per week for eight weeks~'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team.~This warm-up consists of stretching, running and agility drills, in addition to small sided games with a soccer ball, which is not a part of the FIFA11+.~The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement."
11341546|NCT03683758|BG002|Baseline|Total|Total of all reporting groups
11341547|NCT03683758|FG000|Participant Flow|FIFA11+ / Intervention Group|"This group will complete the FIFA11+ warm-up three times per week for eight weeks.~FIFA11+: The FIFA11+ has three parts and consist of 15 exercises.~Part 1 consists of active stretching, running and controlled partner contact drills.~Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups.~Part 3 consists of higher intensity running drills, compared to those covered in Part 1.~Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential."
11341548|NCT03683758|FG001|Participant Flow|Typical Warm-up / Control Group|"This group will complete their usual warm-up three times per week for eight weeks~'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team.~This warm-up consists of stretching, running and agility drills, in addition to small sided games with a soccer ball, which is not included in the FIFA11+.~The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement."
11341549|NCT03683758|OG000|Outcome|FIFA11+ / Intervention Group|"This group will complete the FIFA11+ warm-up three times per week for eight weeks.~FIFA11+: The FIFA11+ has three parts and consist of 15 exercises.~Part 1 consists of active stretching, running and controlled partner contact drills.~Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups.~Part 3 consists of higher intensity running drills, compared to those covered in Part 1.~Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential."
11341550|NCT03683758|OG001|Outcome|Typical Warm-up / Control Group|"This group will complete their usual warm-up three times per week for eight weeks~'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team.~This warm-up consists of stretching, running and agility drills, in addition to small sided games with a soccer ball, which is not included in the FIFA11+.~The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement."
11341551|NCT03683758|EG000|Reported Event|FIFA11+ / Intervention Group|"This group will complete the FIFA11+ warm-up three times per week for eight weeks.~FIFA11+: The FIFA11+ has three parts and consist of 15 exercises.~Part 1 consists of active stretching, running and controlled partner contact drills.~Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups.~Part 3 consists of higher intensity running drills, compared to those covered in Part 1.~Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential."
11341552|NCT03683758|EG001|Reported Event|Typical Warm-up / Control Group|"This group will complete their usual warm-up three times per week for eight weeks~'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team.~This warm-up consists of stretching, running and agility drills, in addition to small sided games with a soccer ball, which is not included in the FIFA11+.~The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement."
11358448|NCT03723980|EG001|Reported Event|Experimental Group or Group II or Propolis Group|Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
11185625|NCT02095691|BG000|Baseline|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
11185626|NCT02095691|FG000|Participant Flow|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
11185627|NCT02095691|OG000|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
11185628|NCT02095691|OG000|Outcome|Change in Blood Pressure at 1 Month Follow up|Change in Blood Pressure from baseline to1 month follow up
11185629|NCT02095691|OG001|Outcome|Change in Blood Pressure at 3 Months Follow Up|Change in Blood Pressure from baseline to3 months follow up
11185630|NCT02095691|OG002|Outcome|Change in Blood Pressure at 6 Months Follow Up|Change in Blood Pressure from baseline to 6 months follow up
11185631|NCT02095691|OG003|Outcome|Change in Blood Pressure at 12 Month Follow Up|Change in Blood Pressure from baseline to 12 months follow up
11185632|NCT02095691|OG000|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP at 1 month follow up
11185633|NCT02095691|OG001|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP at 3 months follow up
11185634|NCT02095691|OG002|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP at 6 months follow up
11185635|NCT02095691|OG003|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP at 12 months follow up
11185636|NCT02095691|OG000|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP reduction at 1 month follow up
11185637|NCT02095691|OG001|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP reduction at 3 months follow up
11185638|NCT02095691|OG002|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP reduction at 6 months follow up
11185639|NCT02095691|OG003|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP reduction at 12 months follow up
11185640|NCT02095691|EG000|Reported Event|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
11185641|NCT02095873|BG000|Baseline|Glyoxalase 1 Inducer Then Placebo|Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks; then Placebo (excipient: 108 mg mannitol), once daily, 8 weeks.
11185642|NCT02095873|BG001|Baseline|Placebo Then Glyoxalase 1 Inducer|Placebo (excipient: 108 mg mannitol), once daily, 8 weeks; then Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
11185643|NCT02095873|BG002|Baseline|Total|Total of all reporting groups
11185644|NCT02095873|FG000|Participant Flow|Glyoxalase 1 Inducer First, Then Placebo|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks; then Placebo (excipient: Mannitol, 108 mg) once daily, 8 weeks.
11185645|NCT02095873|FG001|Participant Flow|Placebo Then Glyoxalase 1 Inducer|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks; then Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
11185646|NCT02095873|OG000|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
11185647|NCT02095873|OG001|Outcome|Placebo|Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
11185648|NCT02095873|OG000|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
11185649|NCT02095873|OG001|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
11358449|NCT03723603|BG000|Baseline|Fibrillar Collagen Powder Dressing|Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.
11358450|NCT03723603|FG000|Participant Flow|Fibrillar Collagen Powder Dressing|Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.
11358451|NCT03723603|OG000|Outcome|Fibrillar Collagen Powder Dressing|Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.
11358452|NCT03723603|EG000|Reported Event|Fibrillar Collagen Powder Dressing|Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.
11358453|NCT03723447|BG000|Baseline|Bupivacaine/Epinephrine/Dexamethasone TAP Block|"For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.~Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively."
11358454|NCT03723447|BG001|Baseline|Liposomal Bupivacaine TAP Block|"For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.~Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively."
11358455|NCT03723447|BG002|Baseline|Total|Total of all reporting groups
11185650|NCT02095873|EG000|Reported Event|Glo1-inducer Then Placebo|Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks; then 6-weeks washout; then placebo capsule (mannitol, 210 mg), once daily for 8 weeks.
11358456|NCT03723447|FG000|Participant Flow|Bupivacaine/Epinephrine/Dexamethasone TAP Block|"For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.~Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively."
11358457|NCT03723447|FG001|Participant Flow|Liposomal Bupivacaine TAP Block|"For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.~Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively."
11358458|NCT03723447|OG000|Outcome|Bupivacaine/Epinephrine/Dexamethasone TAP Block|"For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.~Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively."
11358459|NCT03723447|OG001|Outcome|Liposomal Bupivacaine TAP Block|"For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.~Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively."
11358460|NCT03723447|EG000|Reported Event|Bupivacaine/Epinephrine/Dexamethasone TAP Block|"For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.~Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively."
11358461|NCT03723447|EG001|Reported Event|Liposomal Bupivacaine TAP Block|"For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.~Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively."
11358462|NCT03723070|BG000|Baseline|PV Cryoablation|"Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System~The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins"
11358463|NCT03723070|FG000|Participant Flow|PV Cryoablation|"Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System~The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins"
11185651|NCT02095873|EG001|Reported Event|Placebo Then Glo1-inducer|Placebo capsule (mannitol, 210 mg), once daily for 8 weeks; then 6-weeks washout; then Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks.
11358464|NCT03723070|OG000|Outcome|PV Cryoablation|"Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System~The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins"
11358465|NCT03723070|EG000|Reported Event|PV Cryoablation|"Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System~The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins"
11358466|NCT03720210|BG000|Baseline|RFA Group|"RFA~RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis"
11358467|NCT03720210|FG000|Participant Flow|RFA Group|"RFA (Radiofrequency Ablation)~RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis"
11358468|NCT03720210|OG000|Outcome|RFA Group|"RFA~RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis"
11358469|NCT03720210|EG000|Reported Event|RFA Group|"RFA~RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis"
11358470|NCT03718455|BG000|Baseline|Axillary Magseed|"Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization.~Axillary Magseed: The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy."
11358471|NCT03718455|FG000|Participant Flow|Axillary Magseed|"Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization.~Axillary Magseed: The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy."
11358472|NCT03718455|OG000|Outcome|Axillary Magseed|"Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization.~Axillary Magseed: The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy."
11358473|NCT03718455|EG000|Reported Event|Axillary Magseed|"Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization.~Axillary Magseed: The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy."
11358474|NCT03718143|BG000|Baseline|Total Participants|"Participants from all 3 arms:~Arm A: Elderly Newly Diagnosed AML Arm B: Relapsed AML and MDS Arm C: Relapsed AML, MDS, and MF~Baseline information cannot be separated by diagnoses due to data privacy reasons"
11358475|NCT03718143|FG000|Participant Flow|Arm A: Elderly Newly Diagnosed AML|"Combination AZD1775 with AraC~Elderly, newly diagnosed AML~Combination AZD1775 with AraC: AZD1775 days 1-5 & 8-12 AraC days 1-5 & 8-12"
11358476|NCT03718143|FG001|Participant Flow|Arm B:Relapsed AML and MDS|"Combination AZD1775 with AraC~Relapsed/Refractory AML & HMA failure AML/ MDS~Combination AZD1775 with AraC: AZD1775 days 1-5 & 8-12 AraC days 1-5 & 8-12"
11358477|NCT03718143|FG002|Participant Flow|Arm C: Relapsed AML, MDS and MF|"AZD1775 only~Relapsed/Refractory AML & HMA failure AML/ MDS and Relapsed/Refractory Primary & Secondary MF~AZD1775 only: AZD1775 days 1-5 & 8-12"
11358478|NCT03718143|OG000|Outcome|Arm A: Elderly Newly Diagnosed AML|"Combination AZD1775 with AraC~Elderly, newly diagnosed AML~Combination AZD1775 with AraC: AZD1775 days 1-5 & 8-12 AraC days 1-5 & 8-12"
11358479|NCT03718143|OG001|Outcome|Arm B:Relapsed AML and MDS|"Combination AZD1775 with AraC~Relapsed/Refractory AML & HMA failure AML/ MDS~Combination AZD1775 with AraC: AZD1775 days 1-5 & 8-12 AraC days 1-5 & 8-12"
11358480|NCT03718143|OG002|Outcome|Arm C: Relapsed AML, MDS and MF|"AZD1775 only~Relapsed/Refractory AML & HMA failure AML/ MDS and Relapsed/Refractory Primary & Secondary MF~AZD1775 only: AZD1775 days 1-5 & 8-12"
11358481|NCT03718143|EG000|Reported Event|Arm A: Elderly Newly Diagnosed AML|"Combination AZD1775 with AraC~Elderly, newly diagnosed AML~Combination AZD1775 with AraC: AZD1775 days 1-5 & 8-12 AraC days 1-5 & 8-12"
11358482|NCT03718143|EG001|Reported Event|Arm B:Relapsed AML and MDS|"Combination AZD1775 with AraC~Relapsed/Refractory AML & HMA failure AML/ MDS~Combination AZD1775 with AraC: AZD1775 days 1-5 & 8-12 AraC days 1-5 & 8-12"
11358483|NCT03718143|EG002|Reported Event|Arm C: Relapsed AML, MDS and MF|"AZD1775 only~Relapsed/Refractory AML & HMA failure AML/ MDS and Relapsed/Refractory Primary & Secondary MF~AZD1775 only: AZD1775 days 1-5 & 8-12"
11358484|NCT03709576|BG000|Baseline|Pevonedistat and Azacitidine|The study period is from the start of study treatment, cycle 1 day 1 until 28 days after the last treatment dose. (Cycle 5 day 9). Treatment will be continued until cycle 5 is completed or the study is terminated for the patient. The cycles will be repeated every 28 days. Cycle 1 Day 1 of study treatment will be between day +30 and day +45 post-transplant. Each 28-day cycle is comprised of Pevonedistat at 20 mg/m2 IV infusion over 1 hour on days 1, 3 and 5 and Azacitidine at 25 mg/m2 IV infusion over 30 minutes on days 1, 2, 3, 4, 5, 8 and 9.
11376208|NCT01286272|FG001|Participant Flow|Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)|"INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. >~> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses."
11358485|NCT03709576|FG000|Participant Flow|Pevonedistat and Azacitidine|"The study period is from the start of study treatment, cycle 1 day 1 until 28 days after the last treatment dose. (Cycle 5 day 9). Treatment will be continued until cycle 5 is completed or the study is terminated for the patient. The cycles will be repeated every 28 days. Cycle 1 Day 1 of study treatment will be between day +30 and day +45 post-transplant. Each 28-day cycle is comprised of Pevonedistat at 20 mg/m2 IV infusion over 1 hour on days 1, 3 and 5 and Azacitidine at 25 mg/m2 IV infusion over 30 minutes on days 1, 2, 3, 4, 5, 8 and 9. The drugs can be administered either through a central catheter or a peripheral line.~Pevonedistat: To assess the toxicity and efficacy of a combination of Pevonedistat and Azacitidine as post allogeneic hematopoietic stem cell transplant maintenance therapy for non-remission AML.~transplant: Although hematopoietic stem cell transplantation (HSCT) is curative for many patients with AML, AML in relapse at the time of transplant is still a"
11358486|NCT03709576|OG000|Outcome|Pevonedistat and Azacitidine|"The study period is from the start of study treatment, cycle 1 day 1 until 28 days after the last treatment dose. (Cycle 5 day 9). Treatment will be continued until cycle 5 is completed or the study is terminated for the patient. The cycles will be repeated every 28 days. Cycle 1 Day 1 of study treatment will be between day +30 and day +45 post-transplant. Each 28-day cycle is comprised of Pevonedistat at 20 mg/m2 IV infusion over 1 hour on days 1, 3 and 5 and Azacitidine at 25 mg/m2 IV infusion over 30 minutes on days 1, 2, 3, 4, 5, 8 and 9. The drugs can be administered either through a central catheter or a peripheral line.~Pevonedistat: To assess the toxicity and efficacy of a combination of Pevonedistat and Azacitidine as post allogeneic hematopoietic stem cell transplant maintenance therapy for non-remission AML.~transplant: Although hematopoietic stem cell transplantation (HSCT) is curative for many patients with AML, AML in relapse at the time of transplant is still a"
11358487|NCT03709576|OG000|Outcome|Pevonedistat and Azacitidine|The study period is from the start of study treatment, cycle 1 day 1 until 28 days after the last treatment dose. (Cycle 5 day 9). Treatment will be continued until cycle 5 is completed or the study is terminated for the patient. The cycles will be repeated every 28 days. Cycle 1 Day 1 of study treatment will be between day +30 and day +45 post-transplant. Each 28-day cycle is comprised of Pevonedistat at 20 mg/m2 IV infusion over 1 hour on days 1, 3 and 5 and Azacitidine at 25 mg/m2 IV infusion over 30 minutes on days 1, 2, 3, 4, 5, 8 and 9.
11358488|NCT03709576|EG000|Reported Event|Pevonedistat and Azacitidine|The study period is from the start of study treatment, cycle 1 day 1 until 28 days after the last treatment dose. (Cycle 5 day 9). Treatment will be continued until cycle 5 is completed or the study is terminated for the patient. The cycles will be repeated every 28 days. Cycle 1 Day 1 of study treatment will be between day +30 and day +45 post-transplant. Each 28-day cycle is comprised of Pevonedistat at 20 mg/m2 IV infusion over 1 hour on days 1, 3 and 5 and Azacitidine at 25 mg/m2 IV infusion over 30 minutes on days 1, 2, 3, 4, 5, 8 and 9.
11358489|NCT03704636|BG000|Baseline|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor.~INVSENSOR00028: Noninvasive pulse oximeter sensor"
11358490|NCT03704636|FG000|Participant Flow|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor.~INVSENSOR00028: Noninvasive pulse oximeter sensor"
11358491|NCT03704636|OG000|Outcome|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor.~INVSENSOR00028: Noninvasive pulse oximeter sensor"
11358492|NCT03704636|EG000|Reported Event|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor.~INVSENSOR00028: Noninvasive pulse oximeter sensor"
11358493|NCT03703791|BG000|Baseline|Group 1 (AR101 Treatment + Standard of Care)|"Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance, with an OLFC (open label food challenge) approximately 12 months after randomization.~AR101: AR101 powder"
11358494|NCT03703791|BG001|Baseline|Group 2 (Standard of Care Treatment)|Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.
11358495|NCT03703791|BG002|Baseline|Total|Total of all reporting groups
11358496|NCT03703791|FG000|Participant Flow|Group 1 (AR101 Treatment + Standard of Care)|"Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance, with an OLFC (open label food challenge) approximately 12 months after randomization.~AR101: AR101 powder"
11358497|NCT03703791|FG001|Participant Flow|Group 2 (Standard of Care Treatment)|Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.
11358498|NCT03703791|OG000|Outcome|Group 1 (AR101 Treatment + Standard of Care)|"Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance with an OLFC (open label food challenge) approximately 12 months after randomization.~AR101: AR101 powder"
11358499|NCT03703791|OG001|Outcome|Group 2 (Standard of Care Treatment)|Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.
11358500|NCT03703791|EG000|Reported Event|Group 1 (AR101 Treatment + Standard of Care)|"Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.~AR101: AR101 powder"
11358501|NCT03703791|EG001|Reported Event|Group 2 (Standard of Care Treatment)|Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.
11185652|NCT02095951|BG000|Baseline|Pre-emptive Ethanol Lock Therapy Group|Study intervention group (Arm 1). Received Early Ethanol Lock Therapy before blood culture results were reported as positive or negative.
11358502|NCT03701295|BG000|Baseline|Treatment (Pinometostat, Azacitidine)|"Patients receive pinometostat IV continuously on days 1-28 and azacitidine IV over 10-40 minutes or SC for 7 of the first 10 days of the cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV or SC~Pinometostat: Given IV"
11358503|NCT03701295|FG000|Participant Flow|Treatment (Pinometostat, Azacitidine)|"Patients receive pinometostat IV continuously on days 1-28 and azacitidine IV over 10-40 minutes or SC for 7 of the first 10 days of the cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV or SC~Pinometostat: Given IV"
11358504|NCT03701295|OG000|Outcome|Treatment (Pinometostat, Azacitidine)|"Patients receive pinometostat IV continuously on days 1-28 and azacitidine IV over 10-40 minutes or SC for 7 of the first 10 days of the cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV or SC~Pinometostat: Given IV"
11358505|NCT03701295|EG000|Reported Event|Treatment (Pinometostat, Azacitidine)|"Patients receive pinometostat IV continuously on days 1-28 and azacitidine IV over 10-40 minutes or SC for 7 of the first 10 days of the cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV or SC~Pinometostat: Given IV"
11358506|NCT03697551|BG000|Baseline|68Ga-Satoreotide Trizoxetan|"A single dose of 68Ga-satoreotide trizoxetan was administered as a slow iv bolus injected over 1 minute on Day 1.~The planned, per protocol single dose of 68Ga-satoreotide trizoxetan consisted of a peptide mass up to 45 micrograms, with a radioactivity range of 150-200 MBq."
10961895|NCT00863356|BG000|Baseline|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
11358507|NCT03697551|FG000|Participant Flow|68Ga-Satoreotide Trizoxetan|"A single dose of 68Ga-satoreotide trizoxetan was administered as a slow intravenous (iv) bolus injected over 1 minute on Day 1.~The planned, per protocol single dose of 68Ga-satoreotide trizoxetan consisted of a peptide mass up to 45 micrograms, with a radioactivity range of 150-200 megabecquerel (MBq)."
11358508|NCT03697551|OG000|Outcome|68Ga-Satoreotide Trizoxetan|"A single dose of 68Ga-satoreotide trizoxetan was administered as a slow iv bolus injected over 1 minute on Day 1.~The planned, per protocol single dose of 68Ga-satoreotide trizoxetan consisted of a peptide mass up to 45 micrograms, with a radioactivity range of 150-200 MBq."
11358509|NCT03697551|EG000|Reported Event|68Ga-Satoreotide Trizoxetan|"A single dose of 68Ga-satoreotide trizoxetan was administered as a slow iv bolus injected over 1 minute on Day 1.~The planned, per protocol single dose of 68Ga-satoreotide trizoxetan consisted of a peptide mass up to 45 micrograms, with a radioactivity range of 150-200 MBq."
11358510|NCT03694821|BG000|Baseline|Ketorolac|"One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine~Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine"
11358511|NCT03694821|BG001|Baseline|Corticosteroid|"One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine~Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine"
11358512|NCT03694821|BG002|Baseline|Hyaluronic Acid|"One knee injection of Hylan G-F 20 (Synvisc-One)~Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)"
11358513|NCT03694821|BG003|Baseline|Total|Total of all reporting groups
11358514|NCT03694821|FG000|Participant Flow|Ketorolac|"One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine~Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine"
11358515|NCT03694821|FG001|Participant Flow|Corticosteroid|"One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine~Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine"
11358516|NCT03694821|FG002|Participant Flow|Hyaluronic Acid|"One knee injection of Hylan G-F 20 (Synvisc-One)~Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)"
11358517|NCT03694821|OG000|Outcome|Ketorolac|"One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine~Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine"
11358518|NCT03694821|OG001|Outcome|Corticosteroid|"One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine~Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine"
11358519|NCT03694821|OG002|Outcome|Hyaluronic Acid|"One knee injection of Hylan G-F 20 (Synvisc-One)~Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)"
11358520|NCT03694821|EG000|Reported Event|Ketorolac|One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
11358521|NCT03694821|EG001|Reported Event|Corticosteroid|One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
11358522|NCT03694821|EG002|Reported Event|Hyaluronic Acid|One knee injection of Hylan G-F 20 (Synvisc-One)
11358523|NCT03686969|BG000|Baseline|Octanorm|"0.5g/kg/week octanorm 16.5%~Octanorm: Octanorm 0.5g/kg/week"
11358524|NCT03686969|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo"
11358525|NCT03686969|BG002|Baseline|Total|Total of all reporting groups
11358526|NCT03686969|FG000|Participant Flow|Octanorm|"0.5g/kg/week octanorm 16.5%~Octanorm: Octanorm 0.5g/kg/week"
11358527|NCT03686969|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
11237096|NCT02453321|BG001|Baseline|Cont. Femoral Block - Higher Dose|"Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy~Continuous Femoral Nerve Block: A 27g plastic catheter inserted below the inguinal crease to cause conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
11237097|NCT02453321|BG002|Baseline|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero-medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
11237098|NCT02453321|BG003|Baseline|Total|Total of all reporting groups
11237099|NCT02453321|FG000|Participant Flow|Cont. Femoral Block - Low Dose Group|"Continuous Femoral Block - Low Dose Intervention Group. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of Postoperative Day (POD) #2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupi"
11237100|NCT02453321|FG001|Participant Flow|Cont. Femoral Block - Higher Dose|"Place the Continuous Peripheral Nerve Block (CPNB) in same manner as low-dose group, with increased rate of 4ml/hr. Hypothesis is that this group may experience better pain control, but more motor blockade of thigh and less participation in physical therapy is likely.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform blockade of the sensory components of the femoral nerve to decrease pain in the knee after TKA.~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
11237101|NCT02453321|FG002|Participant Flow|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis: This group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
11237102|NCT02453321|OG000|Outcome|Cont. Femoral Block - Low Dose Group|"Arm is named by the intervention received.. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupi"
11237103|NCT02453321|OG001|Outcome|Cont. Femoral Block - Higher Dose|"Place the CPNB in same manner as low-dose group, but rate to be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
11358528|NCT03686969|OG000|Outcome|Octanorm|"0.5g/kg/week octanorm 16.5%~Octanorm: Octanorm 0.5g/kg/week"
11358529|NCT03686969|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo"
11185653|NCT02095951|BG001|Baseline|Standard Ethanol Lock Therapy Group|Standard of Care Group (Arm 2) that received Ethanol Lock Therapy if and only if the blood culture was positive for growth of an organism.
11185654|NCT02095951|BG002|Baseline|Total|Total of all reporting groups
11185655|NCT02095951|FG000|Participant Flow|Pre-emptive Ethanol Lock Therapy Group|Study intervention group (Arm 1). Received Early Ethanol Lock Therapy before blood culture results were reported as positive or negative.
11185656|NCT02095951|FG001|Participant Flow|Standard Ethanol Lock Therapy Group|Standard of Care Group (Arm 2) that received Ethanol Lock Therapy if and only if the blood culture was positive for growth of an organism.
11185657|NCT02095951|OG000|Outcome|Pre-emptive Ethanol Lock Therapy Group|Pre-emptive Ethanol Lock Therapy Group
11185658|NCT02095951|OG001|Outcome|Standard of Care Ethanol Lock Therapy Group|Standard of Care Ethanol Lock Therapy group
11358530|NCT03686969|EG000|Reported Event|Octanorm|"0.5g/kg/week octanorm 16.5%~Octanorm: Octanorm 0.5g/kg/week"
11185659|NCT02095951|OG000|Outcome|Pre-emptive Ethanol Lock Therapy Group|Study Arm, given pre-emptive ELT
11185660|NCT02095951|OG001|Outcome|Standard Ethanol Lock Therapy Group|Study Arm, given standard of care
11185661|NCT02095951|OG000|Outcome|Pre-emptive Ethanol Lock Therapy Group|Study intervention group (Arm 1). Received Early Ethanol Lock Therapy before blood culture results were reported as positive or negative.
11185662|NCT02095951|OG001|Outcome|Standard Ethanol Lock Therapy Group|Standard of Care Group (Arm 2) that received Ethanol Lock Therapy if and only if the blood culture was positive for growth of an organism.
11185663|NCT02095951|EG000|Reported Event|Arm 1|Study Arm, given pre-emptive ELT
11185664|NCT02095951|EG001|Reported Event|Arm 2|Study Arm, given standard of care
11185665|NCT02096003|BG000|Baseline|Intrathecal Morphine|0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
11185666|NCT02096003|BG001|Baseline|Intrathecal Hydromorphone|50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
11185667|NCT02096003|BG002|Baseline|Total|Total of all reporting groups
11185668|NCT02096003|FG000|Participant Flow|Intrathecal Morphine|"0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections~Intrathecal morphine: 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm."
11185669|NCT02096003|FG001|Participant Flow|Intrathecal Hydromorphone|"50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.~Intrathecal hydromorphone: 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia."
11185670|NCT02096003|OG000|Outcome|Intrathecal Morphine|0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
11185671|NCT02096003|OG001|Outcome|Intrathecal Hydromorphone|50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
11185672|NCT02096003|EG000|Reported Event|Intrathecal Morphine|0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
11185673|NCT02096003|EG001|Reported Event|Intrathecal Hydromorphone|50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
11185674|NCT02096029|BG000|Baseline|Standard Care|Ask, Advise, Refer (physician brief advice)
11185675|NCT02096029|BG001|Baseline|Standard Care + Nicotine Replacement Therapy (NRT)|"2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)~Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch"
11185676|NCT02096029|BG002|Baseline|Total|Total of all reporting groups
11185677|NCT02096029|FG000|Participant Flow|Standard Care|Ask, Advise, Refer (physician brief advice)
11185678|NCT02096029|FG001|Participant Flow|Standard Care + Nicotine Replacement Therapy (NRT)|"2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)~Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch"
11185679|NCT02096029|OG000|Outcome|Standard Care + Nicotine Replacement Therapy (NRT)|"2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)~Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch"
11185680|NCT02096029|OG001|Outcome|Standard Care|Ask, Advise, Refer (physician brief advice)
11185681|NCT02096029|EG000|Reported Event|Standard Care|Ask, Advise, Refer (physician brief advice)
11185682|NCT02096029|EG001|Reported Event|Standard Care + Nicotine Replacement Therapy (NRT)|"2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)~Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch"
11185683|NCT02096081|BG000|Baseline|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
11185684|NCT02096081|BG001|Baseline|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
11185685|NCT02096081|BG002|Baseline|Total|Total of all reporting groups
11185686|NCT02096081|FG000|Participant Flow|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
11185687|NCT02096081|FG001|Participant Flow|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
11185688|NCT02096081|OG000|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
11237104|NCT02453321|OG002|Outcome|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero- medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
11237105|NCT02453321|OG000|Outcome|Cont. Femoral Block - Low Dose Group|"Arm is named by the intervention... Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupi"
11237106|NCT02453321|OG001|Outcome|Cont. Femoral Block - Higher Dose|"Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more motor blockade of thigh and less participation in physical therapy~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
11237107|NCT02453321|OG002|Outcome|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis: This group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
11237108|NCT02453321|EG000|Reported Event|Cont. Femoral Block - Low Dose Group|"Continuous Femoral Nerve Block (CFNB) -Low dose. The Block/catheter is placed about 5cm below groin usually corresponding with the ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~CFNB: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine is 0.0625%"
11237109|NCT02453321|EG001|Reported Event|Cont. Femoral Block - Higher Dose|"CFNB placed in same manner as low-dose group, but rate will be higher (4ml/hr). Hypothesis is this group may experience better pain control, but likely will have more motor blockade of thigh and less participation in physical therapy.~CFNB: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
11237110|NCT02453321|EG002|Reported Event|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior-medial thigh midway between the Anterior Superior Iliac Spine (ASIS) and patella. Intent is to block sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty.~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
11237111|NCT02453334|BG000|Baseline|Injectafer|"2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.~Injectafer"
11237112|NCT02453334|BG001|Baseline|Normal Saline|"Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.~Normal Saline"
11358531|NCT03686969|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11358532|NCT03682367|BG000|Baseline|Control|"Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.~Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively."
11358533|NCT03682367|BG001|Baseline|Intervention|"Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.~Gabapentin: Use of Gabapentin peri- and post-operatively."
11358534|NCT03682367|BG002|Baseline|Total|Total of all reporting groups
11358535|NCT03682367|FG000|Participant Flow|Control|"Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.~Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively."
11185689|NCT02096081|OG001|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
11358536|NCT03682367|FG001|Participant Flow|Intervention|"Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.~Gabapentin: Use of Gabapentin peri- and post-operatively."
11358537|NCT03682367|OG000|Outcome|Control|"Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.~Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively."
11358538|NCT03682367|OG001|Outcome|Intervention|"Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.~Gabapentin: Use of Gabapentin peri- and post-operatively."
11358539|NCT03682367|EG000|Reported Event|Control|"Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.~Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively."
11358540|NCT03682367|EG001|Reported Event|Intervention|"Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.~Gabapentin: Use of Gabapentin peri- and post-operatively."
11358541|NCT03680911|BG000|Baseline|NAC Group|"NAC group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days~N Acetyl Cysteine: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days"
11358542|NCT03680911|BG001|Baseline|Placebo Group|"Placebo group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days~Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days"
11358543|NCT03680911|BG002|Baseline|Total|Total of all reporting groups
11358544|NCT03680911|FG000|Participant Flow|NAC Group|"NAC group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days~N Acetyl Cysteine: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days"
11358545|NCT03680911|FG001|Participant Flow|Placebo Group|"Placebo group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days~Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days"
11185690|NCT02096081|EG000|Reported Event|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
11358546|NCT03680911|OG000|Outcome|NAC Group|"NAC group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days~N Acetyl Cysteine: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days"
11358547|NCT03680911|OG001|Outcome|Placebo Group|"Placebo group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days~Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days"
11358548|NCT03680911|EG000|Reported Event|NAC Group|"NAC group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days~N Acetyl Cysteine: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days"
11358549|NCT03680911|EG001|Reported Event|Placebo Group|"Placebo group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days~Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days"
11358550|NCT03656692|BG000|Baseline|Acthar Gel|Participants receive Acthar Gel
11358551|NCT03656692|FG000|Participant Flow|Acthar Gel|Participants receive Acthar Gel
11358552|NCT03656692|OG000|Outcome|Acthar Gel|Participants receive Acthar Gel
11358553|NCT03656692|EG000|Reported Event|Acthar Gel|Participants receive Acthar Gel
11358554|NCT03648983|BG000|Baseline|Study Population|Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
11358555|NCT03648983|FG000|Participant Flow|Study Population|Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
11358556|NCT03648983|OG000|Outcome|Study Population|Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
11358557|NCT03648983|OG000|Outcome|Study Population|*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***
11358558|NCT03648983|EG000|Reported Event|Study Population|Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
11237113|NCT02453334|BG002|Baseline|Total|Total of all reporting groups
11237114|NCT02453334|FG000|Participant Flow|Injectafer|"2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.~Injectafer"
11237115|NCT02453334|FG001|Participant Flow|Normal Saline|"Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.~Normal Saline"
11237116|NCT02453334|OG000|Outcome|Injectafer|"2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.~Injectafer"
11237117|NCT02453334|OG001|Outcome|Normal Saline|"Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.~Normal Saline"
11237118|NCT02453334|EG000|Reported Event|Injectafer|"2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.~Injectafer"
11237119|NCT02453334|EG001|Reported Event|Normal Saline|"Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.~Normal Saline"
11237120|NCT02453347|BG000|Baseline|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
11237121|NCT02453347|FG000|Participant Flow|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
11237122|NCT02453347|OG000|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
11237123|NCT02453347|EG000|Reported Event|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
11237124|NCT02453360|BG000|Baseline|5 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237125|NCT02453360|BG001|Baseline|10 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237126|NCT02453360|BG002|Baseline|20 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237127|NCT02453360|BG003|Baseline|Total|Total of all reporting groups
11237128|NCT02453360|FG000|Participant Flow|5 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237129|NCT02453360|FG001|Participant Flow|10 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237130|NCT02453360|FG002|Participant Flow|20 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237131|NCT02453360|OG000|Outcome|5 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237132|NCT02453360|OG001|Outcome|10 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237133|NCT02453360|OG002|Outcome|20 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237134|NCT02453360|EG000|Reported Event|5 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237135|NCT02453360|EG001|Reported Event|10 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237136|NCT02453360|EG002|Reported Event|20 ml|"Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.~Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB."
11237137|NCT02453386|BG000|Baseline|Tozadenant 60 mg BID|During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.
11237138|NCT02453386|BG001|Baseline|Tozadenant 120 mg BID|During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
11237139|NCT02453386|BG002|Baseline|Placebo BID|During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.
11237140|NCT02453386|BG003|Baseline|Total|Total of all reporting groups
11237141|NCT02453386|FG000|Participant Flow|Tozadenant 60 mg BID|During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.
11237142|NCT02453386|FG001|Participant Flow|Tozadenant 120 mg BID|During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
11237143|NCT02453386|FG002|Participant Flow|Placebo BID|During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.
11237144|NCT02453386|OG000|Outcome|Placebo BID|Two placebo tablets BID
11237145|NCT02453386|OG001|Outcome|Tozadenant 60 mg BID|One 60 mg tozadenant tablet BID plus 1 Placebo
11237146|NCT02453386|OG002|Outcome|Tozadenant 120 mg BID|Two 60 mg tozadenant tablets BID
11237147|NCT02453386|OG000|Outcome|Placebo|One placebo BID
11237148|NCT02453386|OG002|Outcome|120 mg Tozadanent|Two 60 mg tozadenant tablets BID
11237149|NCT02453386|OG000|Outcome|Placebo|One Placebo BID
11185691|NCT02096081|EG001|Reported Event|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
11185692|NCT02096107|BG000|Baseline|Low Intensity Tacrolimus|"Low tacrolimus, everolimus, and steroids~Everolimus: Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus"
11185693|NCT02096107|BG001|Baseline|Standard of Care|"Tacrolimus, mycophenolate mofetil and steroids~Standard of Care: Tacrolimus, mycophenolate mofetil and steroids"
11185694|NCT02096107|BG002|Baseline|Total|Total of all reporting groups
11185695|NCT02096107|FG000|Participant Flow|Low Intensity Tacrolimus|"Low tacrolimus, everolimus, and steroids~Convert mycophenolate to everolimus (concentration goal of 3-8 ng/mL) with subsequent reduction in exposure to tacrolimus (concentration of 2-5 ng/mL)"
11185696|NCT02096107|FG001|Participant Flow|Standard of Care|"Tacrolimus, mycophenolate mofetil and steroids~Standard of Care: Tacrolimus (concentration goal of 5-12 ng/mL), mycophenolate mofetil and steroids"
11185697|NCT02096107|OG000|Outcome|Low Intensity Tacrolimus|"Low tacrolimus, everolimus, and steroids~Everolimus: Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus"
11185698|NCT02096107|OG001|Outcome|Standard of Care|"Tacrolimus, mycophenolate mofetil and steroids~Standard of Care: Tacrolimus, mycophenolate mofetil and steroids"
11185699|NCT02096107|EG000|Reported Event|Low Intensity Tacrolimus|"Low tacrolimus, everolimus, and steroids~Everolimus: Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus"
11185700|NCT02096107|EG001|Reported Event|Standard of Care|"Tacrolimus, mycophenolate mofetil and steroids~Standard of Care: Tacrolimus, mycophenolate mofetil and steroids"
11185701|NCT02096263|BG000|Baseline|Infanrix Hexa Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185702|NCT02096263|BG001|Baseline|Pediarix Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185703|NCT02096263|BG002|Baseline|Pentacel Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185704|NCT02096263|BG003|Baseline|Total|Total of all reporting groups
11185705|NCT02096263|FG000|Participant Flow|Infanrix Hexa Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185706|NCT02096263|FG001|Participant Flow|Pediarix Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185707|NCT02096263|FG002|Participant Flow|Pentacel Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185708|NCT02096263|OG000|Outcome|Infanrix Hexa Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185709|NCT02096263|OG001|Outcome|Pediarix Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185710|NCT02096263|OG002|Outcome|Pentacel Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185711|NCT02096263|EG000|Reported Event|Infanrix Hexa Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185712|NCT02096263|EG001|Reported Event|Pediarix Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185713|NCT02096263|EG002|Reported Event|Pentacel Group|Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
11185714|NCT02096276|BG000|Baseline|Exposure Group_Prospective|Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and prospective (i.e., registration to registry was done before the outcome of the pregnancy is known)
11185715|NCT02096276|BG001|Baseline|Exposure Group_Retrospective|Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and retrospective (i.e., pregnancy outcome was already known at the time of registration to Registry)
11185716|NCT02096276|BG002|Baseline|Total|Total of all reporting groups
11185717|NCT02096276|FG000|Participant Flow|Exposure Group_Prospective|Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and prospective (i.e., registration to registry was done before the outcome of the pregnancy is known)
11185718|NCT02096276|FG001|Participant Flow|Exposure Group_Retrospective|Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and retrospective (i.e., pregnancy outcome was already known at the time of registration to Registry)
11185719|NCT02096276|OG000|Outcome|Exposure Group_Prospective|Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and prospective (i.e., registration to registry was done before the outcome of the pregnancy is known)
11185720|NCT02096276|OG001|Outcome|Exposure Group_Retrospective|Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and retrospective (i.e., pregnancy outcome was already known at the time of registration to Registry)
11185721|NCT02096276|EG000|Reported Event|Exposure Group_Prospective|Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and prospective (i.e., registration to registry was done before the outcome of the pregnancy is known)
11185722|NCT02096276|EG001|Reported Event|Exposure Group_Retrospective|Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and retrospective (i.e., pregnancy outcome was already known at the time of registration to Registry)
11237150|NCT02453386|OG001|Outcome|Tozadenant 60 mg|One 60 mg tozadenant tablet BID plus 1 Placebo
11185723|NCT02096458|BG000|Baseline|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
11185724|NCT02096458|FG000|Participant Flow|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
11185725|NCT02096458|OG000|Outcome|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
11185726|NCT02096458|EG000|Reported Event|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
11185727|NCT02096471|BG000|Baseline|Agent PD-0325901|"The primary aim of the study will be to assess quantitative radiographic response in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing schedule of 2 mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration, and subjects will receive drug on a 3 week on/1 week off schedule. Subjects may receive additional courses beyond course 8 only if there is at least 15% reduction in volume of the target tumor. Subjects who have a 20% or greater reduction in target tumor volume at the end of 12 courses can continue on therapy for up to an additional year (maximum of 24 total courses). However, subjects who do not achieve at least 15% reduction in volume of the target tumor after 8 courses (~8 months) will be considered treatment failures and taken off study.~PD-0325901"
11185728|NCT02096471|FG000|Participant Flow|Agent PD-0325901|"The primary aim of the study will be to assess quantitative radiographic response in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing schedule of 2 mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration, and subjects will receive drug on a 3 week on/1 week off schedule. Subjects may receive additional courses beyond course 8 only if there is at least 15% reduction in volume of the target tumor. Subjects who have a 20% or greater reduction in target tumor volume at the end of 12 courses can continue on therapy for up to an additional year (maximum of 24 total courses). However, subjects who do not achieve at least 15% reduction in volume of the target tumor after 8 courses (~8 months) will be considered treatment failures and taken off study.~PD-0325901"
11237151|NCT02453386|OG002|Outcome|Tozadenant 120 mg|Two 60 mg tozadenant tablets BID
11237152|NCT02453386|OG000|Outcome|Placebo|One Placebo
11237153|NCT02453386|OG002|Outcome|Tozadanent 120 mg|Two 60 mg tozadenant tablets BID
11237154|NCT02453386|EG000|Reported Event|Tozadenant 60 mg BID|"Part A (double-blind phase)~During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day."
11237155|NCT02453386|EG001|Reported Event|Tozadenant 120 mg BID|"Part A (double-blind phase)~During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day."
11237156|NCT02453386|EG002|Reported Event|Placebo BID|"Part A (double-blind phase)~During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day."
11237157|NCT02453555|BG000|Baseline|Empagliflozin 10 mg/Linagliptin 5 mg|Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
11237158|NCT02453555|BG001|Baseline|Linagliptin 5 mg + Placebo 10 mg|Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
11237159|NCT02453555|BG002|Baseline|Total|Total of all reporting groups
11237160|NCT02453555|FG000|Participant Flow|Empagliflozin 10 Milligram (mg)/Linagliptin 5 Milligram (mg)|Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
11237161|NCT02453555|FG001|Participant Flow|Linagliptin 5 mg + Placebo 10 mg|Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
11237162|NCT02453555|FG002|Participant Flow|Empagliflozin 25 mg/Linagliptin 5 mg (Extension Period)|Patients with insufficient response based on Glycosylated haemoglobin A1c (HbA1c) after 24-week of double-blind treatment period were up-titrated to a FDC of 25 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of up-titration period (from Week 28 to Week 52).
11237163|NCT02453555|FG003|Participant Flow|Empagliflozin 10 mg/Linagliptin 5 mg (Extension Period)|Patients with sufficient response based on HbA1c after 24-week of double-blind treatment period were continued on a FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for subsequent 28 weeks of extension period.
11237164|NCT02453555|FG004|Participant Flow|Linagliptin 5 mg + Placebo 25 mg (Extension Period)|Patients with insufficient response based on HbA1c after 24-week of double-blind treatment period were up-titrated to receive a matching placebo of FDC of 25 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of up-titration period (from Week 28 to Week 52).
11237165|NCT02453555|FG005|Participant Flow|Linagliptin 5 mg + Placebo 10 mg (Extension Period)|Patients with sufficient response based on HbA1c after 24-week of double-blind treatment period were continued on a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for subsequent 28 weeks of extension period.
11237166|NCT02453555|OG000|Outcome|Empagliflozin 10 mg/Linagliptin 5 mg|Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
11237167|NCT02453555|OG001|Outcome|Linagliptin 5 mg + Placebo 10 mg|Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
11237168|NCT02453555|OG000|Outcome|Empagliflozin 25 mg/Linagliptin 5 mg|Patients with insufficient response based on HbA1c after 24-week of double-blind treatment period were up-titrated to a FDC of 25 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of up-titration period (from Week 28 to Week 52).
11237169|NCT02453555|OG000|Outcome|All Empagliflozin|Patients were administered a FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period. In the up-titration period (from Week 28 to Week 52), patients with insufficient response measured after 24 weeks of double-blind treatment got up-titrated to FDC of 25 mg Empagliflozin and 5 mg Linagliptin while the other patients kept the same dose.
11237170|NCT02453555|OG001|Outcome|All Placebo|Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period. In the up-titration period (from Week 28 to Week 52), patients with insufficient response measured after 24 weeks of double-blind treatment got up-titrated to matching placebo of FDC of 25 mg Empagliflozin and 5 mg Linagliptin while the other patients kept the same dose.
11237171|NCT02453555|OG001|Outcome|Linagliptin 5 mg + Placebo 25 mg|Patients with insufficient response based on HbA1c after 24-week of double-blind treatment period were up-titrated to receive a matching placebo of FDC of 25 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of up-titration period (from Week 28 to Week 52).
11237172|NCT02453555|EG000|Reported Event|All Empagliflozin|Patients were administered a FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period. In the up-titration period (from Week 28 to Week 52), patients with insufficient response measured after 24 weeks of double-blind treatment got up-titrated to FDC of 25 mg Empagliflozin and 5 mg Linagliptin while the other patients kept the same dose.
11237173|NCT02453555|EG001|Reported Event|All Placebo|Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period. In the up-titration period (from Week 28 to Week 52), patients with insufficient response measured after 24 weeks of double-blind treatment got up-titrated to matching placebo of FDC of 25 mg Empagliflozin and 5 mg Linagliptin while the other patients kept the same dose.
11237174|NCT02453581|BG000|Baseline|Randomised Participants|Twenty-four male and female subjects were enrolled in the study.
11237175|NCT02453581|FG000|Participant Flow|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
11237176|NCT02453581|FG001|Participant Flow|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
11237177|NCT02453581|FG002|Participant Flow|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
11237178|NCT02453581|OG000|Outcome|OZ439 500mg - R017|Cohort 3 - OZ439 500mg - Subject R017
11237179|NCT02453581|OG001|Outcome|OZ439 500mg - R018|Cohort 3 - OZ439 500mg - Subject R018
11237180|NCT02453581|OG002|Outcome|OZ439 500mg - R019|Cohort 3 - OZ439 500mg - Subject R019
11237181|NCT02453581|OG003|Outcome|OZ439 500mg - R020|Cohort 3 - OZ439 500mg - Subject R020
11237182|NCT02453581|OG004|Outcome|OZ439 500mg - R021|Cohort 3 - OZ439 500mg - Subject R021
11237183|NCT02453581|OG005|Outcome|OZ439 500mg - R022|Cohort 3 - OZ439 500mg - Subject R022
11237184|NCT02453581|OG006|Outcome|OZ439 500mg - R023|Cohort 3 - OZ439 500mg - Subject R023
11237185|NCT02453581|OG007|Outcome|OZ439 500mg - R024|Cohort 3 - OZ439 500mg - Subject R024
11237186|NCT02453581|OG000|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
11237187|NCT02453581|OG001|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
11237188|NCT02453581|OG002|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
11237189|NCT02453581|OG000|Outcome|OZ439 500mg Arm|Cohort 3 - OZ439 500mg
11237190|NCT02453581|EG000|Reported Event|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
11237191|NCT02453581|EG001|Reported Event|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
11237192|NCT02453581|EG002|Reported Event|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
11237193|NCT02453672|BG000|Baseline|SB8 (Proposed Bevacizumab Biosimilar)|"SB8, single dose of 3 mg/kg, IV infusion~SB8: SB8, proposed bevacizumab biosimilar"
11237194|NCT02453672|BG001|Baseline|EU Sourced Avastin®|"EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion~EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)"
11237195|NCT02453672|BG002|Baseline|US Sourced Avastin®|"US Sourced Avastin®, single dose of 3 mg/kg, IV infusion~US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)"
11237196|NCT02453672|BG003|Baseline|Total|Total of all reporting groups
11237197|NCT02453672|FG000|Participant Flow|SB8 (Proposed Bevacizumab Biosimilar)|"SB8, single dose of 3 mg/kg, IV infusion~SB8: SB8, proposed bevacizumab biosimilar"
11237198|NCT02453672|FG001|Participant Flow|EU Sourced Avastin®|"EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion~EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)"
11237199|NCT02453672|FG002|Participant Flow|US Sourced Avastin®|"US Sourced Avastin®, single dose of 3 mg/kg, IV infusion~US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)"
11237200|NCT02453672|OG000|Outcome|SB8 (Proposed Bevacizumab Biosimilar)|"SB8, single dose of 3 mg/kg, IV infusion~SB8: SB8, proposed bevacizumab biosimilar"
11237201|NCT02453672|OG001|Outcome|EU Sourced Avastin®|"EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion~EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)"
11237202|NCT02453672|OG002|Outcome|US Sourced Avastin®|"US Sourced Avastin®, single dose of 3 mg/kg, IV infusion~US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)"
11237203|NCT02453672|EG000|Reported Event|SB8 (Proposed Bevacizumab Biosimilar)|"SB8, single dose of 3 mg/kg, IV infusion~SB8: SB8, proposed bevacizumab biosimilar"
11237204|NCT02453672|EG001|Reported Event|EU Sourced Avastin®|"EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion~EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)"
11237205|NCT02453672|EG002|Reported Event|US Sourced Avastin®|"US Sourced Avastin®, single dose of 3 mg/kg, IV infusion~US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)"
11237206|NCT02453685|BG000|Baseline|BIAsp 30|Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
11237207|NCT02453685|BG001|Baseline|Basal-bolus|Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
11237208|NCT02453685|BG002|Baseline|Total|Total of all reporting groups
11240886|NCT02482675|FG004|Participant Flow|Glucose, Then Sodium Caseinate, Then Whey Protein, Then Milk|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11341803|NCT03688620|OG002|Outcome|Vaccinated_Fluarix Tetra Group|Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
11358559|NCT03643159|BG000|Baseline|Abilify MyCite|Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
11358560|NCT03643159|BG001|Baseline|Virtual Matched Controls|Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.
11358561|NCT03643159|BG002|Baseline|Total|Total of all reporting groups
11358562|NCT03643159|FG000|Participant Flow|Abilify MyCite|Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
11358563|NCT03643159|OG000|Outcome|Abilify MyCite|Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
11358564|NCT03643159|OG001|Outcome|Virtual Matched Controls|Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.
11358565|NCT03643159|EG000|Reported Event|Abilify MyCite|Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
11358566|NCT03632655|BG000|Baseline|Transrectal Ultrasound Guided Biopsy (TRUS)|"Patients will receive a transrectal guided prostate biopsy~prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy"
11358567|NCT03632655|BG001|Baseline|Transperineal Prostate Biopsy|"Patients will receive a transperineal prostate biopsy~prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy"
11358568|NCT03632655|BG002|Baseline|Total|Total of all reporting groups
11358569|NCT03632655|FG000|Participant Flow|Transrectal Ultrasound Guided Biopsy (TRUS)|"Patients will receive a transrectal guided prostate biopsy~prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy"
11358570|NCT03632655|FG001|Participant Flow|Transperineal Prostate Biopsy|"Patients will receive a transperineal prostate biopsy~prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy"
11358571|NCT03632655|OG000|Outcome|Transrectal Ultrasound Guided Biopsy (TRUS)|"Patients will receive a transrectal guided prostate biopsy~prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy"
11358572|NCT03632655|OG001|Outcome|Transperineal Prostate Biopsy|"Patients will receive a transperineal prostate biopsy~prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy"
11358573|NCT03632655|EG000|Reported Event|Transrectal Ultrasound Guided Biopsy (TRUS)|"Patients will receive a transrectal guided prostate biopsy~prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy"
11358574|NCT03632655|EG001|Reported Event|Transperineal Prostate Biopsy|"Patients will receive a transperineal prostate biopsy~prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy"
11358575|NCT03630120|BG000|Baseline|Standard of Care: DTC|"Standard of Care (SOC) TKI Therapy for Differentiated Thyroid Cancer (DTC): Lenvatinib + Sorafenib.~Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358576|NCT03630120|BG001|Baseline|Adaptive Care: DTC|"SOC followed by Adaptive Care TKI Therapy for DTC Participants with >=50% drop: Lenvatinib + Sorafenib.~Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358577|NCT03630120|BG002|Baseline|Standard of Care: MTC|"Standard of Care (SOC) TKI Therapy for Medullary Thyroid Cancer: Cabozantinib + Vandetanib.~Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358578|NCT03630120|BG003|Baseline|Adaptive Care: MTC|"SOC followed by Adaptive Care TKI Therapy for MTC Participants with >=50% drop: Cabozantinib + Vandetanib.~Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358579|NCT03630120|BG004|Baseline|Total|Total of all reporting groups
11358580|NCT03630120|FG000|Participant Flow|Standard of Care: DTC|Standard of Care (SOC) TKI Therapy for Differentiated Thyroid Cancer (DTC): Lenvatinib + Sorafenib.
11358581|NCT03630120|FG001|Participant Flow|Adaptive Care: DTC|"SOC followed by Adaptive Care TKI Therapy for DTC Participants with >=50% drop: Lenvatinib + Sorafenib.~Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358582|NCT03630120|FG002|Participant Flow|Standard of Care: MTC|Standard of Care (SOC) TKI Therapy for Medullary Thyroid Cancer: Cabozantinib + Vandetanib.
11358583|NCT03630120|FG003|Participant Flow|Adaptive Care: MTC|"SOC followed by Adaptive Care TKI Therapy for MTC Participants with >=50% drop: Cabozantinib + Vandetanib.~Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358584|NCT03630120|OG000|Outcome|Standard of Care: DTC|"Standard of Care (SOC) TKI Therapy for Differentiated Thyroid Cancer (DTC): Lenvatinib + Sorafenib.~Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358585|NCT03630120|OG001|Outcome|Adaptive Care: DTC|"SOC followed by Adaptive Care TKI Therapy for DTC Participants with >=50% drop: Lenvatinib + Sorafenib.~Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358586|NCT03630120|OG002|Outcome|Standard of Care: MTC|"Standard of Care (SOC) TKI Therapy for Medullary Thyroid Cancer: Cabozantinib + Vandetanib.~Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11237209|NCT02453685|FG000|Participant Flow|BIAsp 30|Subjects received subcutaneous (s.c.) injection of biphasic insulin aspart 30 (BIAsp 30-a mixture of soluble insulin aspart [IAsp] 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal self-measured plasma glucose (SMPG) target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (hemoglobin A1c [HbA1c] <7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and sulphonylurea (SU) throughout the trial.
11237210|NCT02453685|FG001|Participant Flow|Basal-bolus|Subjects received s.c. injections of insulin glargine (IGlar) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
11237211|NCT02453685|OG000|Outcome|BIAsp 30|Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
11237212|NCT02453685|OG001|Outcome|Basal-bolus|Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
11237213|NCT02453685|EG000|Reported Event|BIAsp 30|Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
11237214|NCT02453685|EG001|Reported Event|Basal-bolus|Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
11237215|NCT02453711|BG000|Baseline|Semaglutide 0.05 mg|Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
11237216|NCT02453711|BG001|Baseline|Semaglutide 0.1 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
11237217|NCT02453711|BG002|Baseline|Semaglutide 0.2 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
11237218|NCT02453711|BG003|Baseline|Semaglutide 0.3 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
11237219|NCT02453711|BG004|Baseline|Semaglutide 0.4 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
11237220|NCT02453711|BG005|Baseline|Semaglutide 0.3 mg (Fast Escalation)|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
11237221|NCT02453711|BG006|Baseline|Semaglutide 0.4 mg (Fast Escalation)|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
11237222|NCT02453711|BG007|Baseline|Liraglutide 3.0 mg|Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
11237223|NCT02453711|BG008|Baseline|Placebo Pool|Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
11237224|NCT02453711|BG009|Baseline|Total|Total of all reporting groups
11237225|NCT02453711|FG000|Participant Flow|Semaglutide 0.05 mg|Participants received once daily semaglutide 0.05 mg subcutaneous (s.c.; under the skin) injections for 52 weeks.
11237226|NCT02453711|FG001|Participant Flow|Semaglutide 0.1 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
11237227|NCT02453711|FG002|Participant Flow|Semaglutide 0.2 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
11237228|NCT02453711|FG003|Participant Flow|Semaglutide 0.3 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
11237229|NCT02453711|FG004|Participant Flow|Semaglutide 0.4 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
11237230|NCT02453711|FG005|Participant Flow|Semaglutide 0.3 mg (Fast Escalation)|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
11237231|NCT02453711|FG006|Participant Flow|Semaglutide 0.4 mg (Fast Escalation)|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
11237232|NCT02453711|FG007|Participant Flow|Liraglutide 3.0 mg|Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
11237233|NCT02453711|FG008|Participant Flow|Placebo Pool|Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
11237234|NCT02453711|OG000|Outcome|Semaglutide 0.05 mg|Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
11237235|NCT02453711|OG001|Outcome|Semaglutide 0.1 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
11237236|NCT02453711|OG002|Outcome|Semaglutide 0.2 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
11237237|NCT02453711|OG003|Outcome|Semaglutide 0.3 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
11237238|NCT02453711|OG004|Outcome|Semaglutide 0.4 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
11237239|NCT02453711|OG005|Outcome|Semaglutide 0.3 mg (Fast Escalation)|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
11237240|NCT02453711|OG006|Outcome|Semaglutide 0.4 mg (Fast Escalation)|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
11237241|NCT02453711|OG007|Outcome|Liraglutide 3.0 mg|Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
11237242|NCT02453711|OG008|Outcome|Placebo Pool|Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
11237243|NCT02453711|EG000|Reported Event|Semaglutide 0.05 mg|Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
11237244|NCT02453711|EG001|Reported Event|Semaglutide 0.1 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
11237245|NCT02453711|EG002|Reported Event|Semaglutide 0.2 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
11237246|NCT02453711|EG003|Reported Event|Semaglutide 0.3 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
11237247|NCT02453711|EG004|Reported Event|Semaglutide 0.4 mg|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
11237248|NCT02453711|EG005|Reported Event|Semaglutide 0.3 mg (Fast Escalation)|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
11237249|NCT02453711|EG006|Reported Event|Semaglutide 0.4 mg (Fast Escalation)|Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
11237250|NCT02453711|EG007|Reported Event|Liraglutide 3.0 mg|Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
11237251|NCT02453711|EG008|Reported Event|Placebo Pool|Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
11237252|NCT02453750|BG000|Baseline|Hypersaline and Bronchodilator Response|After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer to obtain cells for analysis.
11237253|NCT02453750|FG000|Participant Flow|Hypersaline and Bronchodilator Response|Each child will perform a sputum induction to obtain cells for analysis.
11237254|NCT02453750|OG000|Outcome|Hypersaline and Bronchodilator Response|everyone performs sputum induction
11237255|NCT02453750|OG000|Outcome|Hypersaline and Bronchodilator Response|After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.
11237256|NCT02453750|OG000|Outcome|Hypersaline and Bronchodilator Response|eNO measured
11237257|NCT02453750|OG000|Outcome|Hypersaline and Bronchodilator Response|spiro performed at start of visit
11237258|NCT02453750|EG000|Reported Event|Hypersaline and Bronchodilator Response|After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.
11237259|NCT02453841|BG000|Baseline|Children Undergoing ENT Surgery|Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
11237260|NCT02453841|FG000|Participant Flow|Children Undergoing ENT Surgery|Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
11237261|NCT02453841|OG000|Outcome|Children Undergoing ENT Surgery|Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
11237262|NCT02453841|EG000|Reported Event|Children Undergoing ENT Surgery|Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
11237263|NCT02454075|BG000|Baseline|Eligible Patients|"The dose will be 100 mg YF476 once daily. When 6 patients have completed 12 weeks' treatment with that dose, it may be increased to 150 or 200 mg once daily. Patients will have type II gastric carcinoids and/or ECL cell hyperplasia/dysplasia.~YF476: Gastrin receptor antagonist"
11237264|NCT02454075|FG000|Participant Flow|Eligible Patients|Patients received 100 mg YF476 orally once daily for 12 weeks.
11237265|NCT02454075|OG000|Outcome|Eligible Patients|"The dose will be 100 mg YF476 once daily. When 6 patients have completed 12 weeks' treatment with that dose, it may be increased to 150 or 200 mg once daily. Patients will have type II gastric carcinoids and/or ECL cell hyperplasia/dysplasia.~YF476: Gastrin receptor antagonist"
11237266|NCT02454075|OG000|Outcome|Eligible Patients|Patients received 100 mg YF476 orally once daily for 12 weeks.
11237267|NCT02454075|OG000|Outcome|Eligible Patients|"The dose will be an oral dose of 100 mg YF476 once daily for 12 weeks. When 6 patients have completed 12 weeks' treatment with that dose, it may be increased to 150 or 200 mg once daily. Patients will have type II gastric carcinoids and/or ECL cell hyperplasia/dysplasia.~YF476: Gastrin receptor antagonist"
11237268|NCT02454075|EG000|Reported Event|Eligible Patients|"The dose will be an oral dose of 100 mg YF476 once daily. for 12 weeks. When 6 patients have completed 12 weeks' treatment with that dose, it may be increased to 150 or 200 mg once daily. Patients will have type II gastric carcinoids and/or ECL cell hyperplasia/dysplasia.~YF476: Gastrin receptor antagonist"
11237269|NCT02454101|BG000|Baseline|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
11237270|NCT02454101|BG001|Baseline|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
11237271|NCT02454101|BG002|Baseline|Total|Total of all reporting groups
11237272|NCT02454101|FG000|Participant Flow|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
11237273|NCT02454101|FG001|Participant Flow|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
11237274|NCT02454101|OG000|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
11237275|NCT02454101|OG001|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
11237276|NCT02454101|EG000|Reported Event|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
11237277|NCT02454101|EG001|Reported Event|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
11185729|NCT02096471|OG000|Outcome|Agent PD-0325901|"The primary aim of the study will be to assess quantitative radiographic response in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing schedule of 2 mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration, and subjects will receive drug on a 3 week on/1 week off schedule. Subjects may receive additional courses beyond course 8 only if there is at least 15% reduction in volume of the target tumor. Subjects who have a 20% or greater reduction in target tumor volume at the end of 12 courses can continue on therapy for up to an additional year (maximum of 24 total courses). However, subjects who do not achieve at least 15% reduction in volume of the target tumor after 8 courses (~8 months) will be considered treatment failures and taken off study.~PD-0325901"
11185730|NCT02096471|EG000|Reported Event|Agent PD-0325901|"The primary aim of the study will be to assess quantitative radiographic response in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing schedule of 2 mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration, and subjects will receive drug on a 3 week on/1 week off schedule. Subjects may receive additional courses beyond course 8 only if there is at least 15% reduction in volume of the target tumor. Subjects who have a 20% or greater reduction in target tumor volume at the end of 12 courses can continue on therapy for up to an additional year (maximum of 24 total courses). However, subjects who do not achieve at least 15% reduction in volume of the target tumor after 8 courses (~8 months) will be considered treatment failures and taken off study.~PD-0325901"
11185731|NCT02096575|BG000|Baseline|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration"
11185732|NCT02096575|BG001|Baseline|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
11185733|NCT02096575|BG002|Baseline|Total|Total of all reporting groups
11185734|NCT02096575|FG000|Participant Flow|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration"
11185735|NCT02096575|FG001|Participant Flow|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
11185736|NCT02096575|FG002|Participant Flow|Excluded|Participants that were withdrawn from the study after consent
11185737|NCT02096575|OG000|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
11185738|NCT02096575|OG001|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
11185739|NCT02096575|OG000|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
11185740|NCT02096575|EG000|Reported Event|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
11237278|NCT02454127|BG000|Baseline|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
11237279|NCT02454127|BG001|Baseline|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
11185741|NCT02096575|EG001|Reported Event|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
11185742|NCT02096679|BG000|Baseline|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
11185743|NCT02096679|FG000|Participant Flow|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
11185744|NCT02096679|OG000|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
11185745|NCT02096679|EG000|Reported Event|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
11185746|NCT02096692|BG000|Baseline|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
11185747|NCT02096692|FG000|Participant Flow|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
11185748|NCT02096692|OG000|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
11185749|NCT02096692|EG000|Reported Event|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
11185750|NCT02096705|BG000|Baseline|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
11185751|NCT02096705|BG001|Baseline|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
11185752|NCT02096705|BG002|Baseline|Total|Total of all reporting groups
11185753|NCT02096705|FG000|Participant Flow|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
11185754|NCT02096705|FG001|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
11185755|NCT02096705|OG000|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
11185756|NCT02096705|OG001|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
11185757|NCT02096705|EG000|Reported Event|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
11185758|NCT02096705|EG001|Reported Event|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
11185759|NCT02096718|BG000|Baseline|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
11185760|NCT02096718|BG001|Baseline|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
11185761|NCT02096718|BG002|Baseline|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
11185762|NCT02096718|BG003|Baseline|Total|Total of all reporting groups
11185763|NCT02096718|FG000|Participant Flow|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
11185764|NCT02096718|FG001|Participant Flow|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
11185765|NCT02096718|FG002|Participant Flow|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
11185766|NCT02096718|OG000|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
11185767|NCT02096718|OG001|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
11185768|NCT02096718|OG002|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
11185769|NCT02096718|OG003|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
11185770|NCT02096718|EG000|Reported Event|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
11185771|NCT02096718|EG001|Reported Event|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
11185772|NCT02096718|EG002|Reported Event|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
11185773|NCT02096731|BG000|Baseline|Tiotropium|Participants who were new users of tiotropium.
11237280|NCT02454127|BG002|Baseline|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
11237281|NCT02454127|BG003|Baseline|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
11237282|NCT02454127|BG004|Baseline|Total|Total of all reporting groups
11237283|NCT02454127|FG000|Participant Flow|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
11237284|NCT02454127|FG001|Participant Flow|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
11237285|NCT02454127|FG002|Participant Flow|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
11237286|NCT02454127|FG003|Participant Flow|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
11237287|NCT02454127|OG000|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
11237288|NCT02454127|OG001|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
11237289|NCT02454127|OG002|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
11237290|NCT02454127|OG003|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
11237291|NCT02454127|EG000|Reported Event|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
11237292|NCT02454127|EG001|Reported Event|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
11237293|NCT02454127|EG002|Reported Event|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
11237294|NCT02454127|EG003|Reported Event|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
11237295|NCT02454153|BG000|Baseline|REMStar Positive Airway Pressure|"Positive pressure therapy is the standard of care for managing obstructive sleep apnea.~REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea"
11237296|NCT02454153|BG001|Baseline|LifeStyle Counseling|"Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.~LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects."
11237297|NCT02454153|BG002|Baseline|Total|Total of all reporting groups
11237298|NCT02454153|FG000|Participant Flow|REMStar Positive Airway Pressure|"Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.~REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea~Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.~LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects."
11237299|NCT02454153|FG001|Participant Flow|LifeStyle Counseling|"Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.~LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects."
11237300|NCT02454153|OG000|Outcome|REMStar Positive Airway Pressure|"Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.~REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea~Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.~LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects."
11237301|NCT02454153|OG001|Outcome|LifeStyle Counseling|"Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.~LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects."
11237302|NCT02454153|OG000|Outcome|REMStar Positive Airway Pressure|"Positive pressure therapy is the standard of care for managing obstructive sleep apnea.~REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea.~Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.~LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects."
11237303|NCT02454153|EG000|Reported Event|REMStar Positive Airway Pressure|"Positive pressure therapy is the standard of care for managing obstructive sleep apnea.~REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea"
11237304|NCT02454153|EG001|Reported Event|LifeStyle Counseling|"Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.~LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects."
11237305|NCT02454179|BG000|Baseline|Mono Therapy Arm - Pembrolizumab|Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11237306|NCT02454179|BG001|Baseline|Combo Therapy Arm - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11237307|NCT02454179|BG002|Baseline|Total|Total of all reporting groups
11237308|NCT02454179|FG000|Participant Flow|Mono Therapy of Pembrolizumab Arm 1|Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11237309|NCT02454179|FG001|Participant Flow|Combo Therapy Acalabrutinib + Pembrolizumab Arm 2|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11237310|NCT02454179|OG000|Outcome|Mono Therapy Arm - Pembrolizumab|Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11237311|NCT02454179|OG001|Outcome|Combo Therapy Arm - Acalabrutinib and Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11237312|NCT02454179|EG000|Reported Event|Arm 1 - Pembrolizumab|Pembrolizumab Monotherapy
11237313|NCT02454179|EG001|Reported Event|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib in combination with Pembrolizumab
11358587|NCT03630120|OG003|Outcome|Adaptive Care: MTC|"SOC followed by Adaptive Care TKI Therapy for MTC Participants with >=50% drop: Cabozantinib + Vandetanib.~Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358588|NCT03630120|EG000|Reported Event|Standard of Care: DTC|"Standard of Care (SOC) TKI Therapy for Differentiated Thyroid Cancer (DTC): Lenvatinib + Sorafenib.~Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358589|NCT03630120|EG001|Reported Event|Adaptive Care: DTC|"SOC followed by Adaptive Care TKI Therapy for DTC Participants with >=50% drop: Lenvatinib + Sorafenib.~Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358590|NCT03630120|EG002|Reported Event|Standard of Care: MTC|"Standard of Care (SOC) TKI Therapy for Medullary Thyroid Cancer: Cabozantinib + Vandetanib.~Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358591|NCT03630120|EG003|Reported Event|Adaptive Care: MTC|"SOC followed by Adaptive Care TKI Therapy for MTC Participants with >=50% drop: Cabozantinib + Vandetanib.~Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level.~Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
11358592|NCT03621657|BG000|Baseline|Low Dose FMT Capsule DE|"FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic~Low Dose FMT Capsule DE: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course."
11358593|NCT03621657|BG001|Baseline|Placebo Oral Capsule|"Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic~Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment."
11358594|NCT03621657|BG002|Baseline|Single Dose FMT Capsule DE|"FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.~Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment."
11358595|NCT03621657|BG003|Baseline|Total|Total of all reporting groups
11237314|NCT02454283|BG000|Baseline|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
11237315|NCT02454283|BG001|Baseline|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
11237316|NCT02454283|BG002|Baseline|Total|Total of all reporting groups
11237317|NCT02454283|FG000|Participant Flow|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
11237318|NCT02454283|FG001|Participant Flow|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
11237319|NCT02454283|OG000|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
11237320|NCT02454283|OG001|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
11237321|NCT02454283|EG000|Reported Event|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
11237322|NCT02454283|EG001|Reported Event|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
11237323|NCT02454296|BG000|Baseline|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
11237324|NCT02454296|BG001|Baseline|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
11237325|NCT02454296|BG002|Baseline|Total|Total of all reporting groups
11237326|NCT02454296|FG000|Participant Flow|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
11237327|NCT02454296|FG001|Participant Flow|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
11237328|NCT02454296|OG000|Outcome|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
11237329|NCT02454296|OG001|Outcome|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
11237330|NCT02454296|OG000|Outcome|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
11237331|NCT02454296|OG001|Outcome|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
11237332|NCT02454296|EG000|Reported Event|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
11237333|NCT02454296|EG001|Reported Event|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
11237334|NCT02454478|BG000|Baseline|Lenvatinib 18 mg + Everolimus 5 mg|Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
11237335|NCT02454478|FG000|Participant Flow|Lenvatinib 18 mg + Everolimus 5 mg|Participants received lenvatinib 18 milligram (mg) capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
11237336|NCT02454478|OG000|Outcome|Lenvatinib 18 mg + Everolimus 5 mg|Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
11237337|NCT02454478|EG000|Reported Event|Lenvatinib 18 mg + Everolimus 5 mg|Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue withdrawal of consent, or study termination by sponsor (up to 23 cycles).
11237338|NCT02454530|BG000|Baseline|Adjuvant Chemotherapy|Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.
11237339|NCT02454530|BG001|Baseline|Metastatic Chemotherapy|Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
11237340|NCT02454530|BG002|Baseline|Total|Total of all reporting groups
11237341|NCT02454530|FG000|Participant Flow|Adjuvant Chemotherapy|Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.
11237342|NCT02454530|FG001|Participant Flow|Metastatic Chemotherapy|Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
11237343|NCT02454530|OG000|Outcome|Adjuvant Chemotherapy|Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.
11237344|NCT02454530|OG001|Outcome|Metastatic Chemotherapy|Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
11237345|NCT02454530|OG000|Outcome|Adjuvant or Metastatic Chemotherapy|Participants with previous solid tumour who were prescribed Nivestim at the inclusion visit (Week 1), and were receiving adjuvant or metastatic type of chemotherapy after first course of Nivestim (maximum duration was 15 days for adjuvant chemotherapy and 10 days for metastatic chemotherapy) were observed for a maximum of 2.25 years in this study.
11237346|NCT02454530|EG000|Reported Event|Adjuvant Chemotherapy|Participants who were receiving chemotherapy for solid tumor in the adjuvant setting and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated (maximum duration was 15 days) were observed for a maximum of 2.25 years in this study.
11237347|NCT02454530|EG001|Reported Event|Metastatic Chemotherapy|Participants who were receiving chemotherapy for solid tumor in the metastatic setting and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) was initiated (maximum duration was 10 days) were observed for a maximum of 2.25 years in this study.
11237348|NCT02454608|BG000|Baseline|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
11237349|NCT02454608|BG001|Baseline|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
11237350|NCT02454608|BG002|Baseline|Open Label|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
11237351|NCT02454608|BG003|Baseline|Total|Total of all reporting groups
11237352|NCT02454608|FG000|Participant Flow|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
11237353|NCT02454608|FG001|Participant Flow|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
11237354|NCT02454608|FG002|Participant Flow|Open Label|Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
11237355|NCT02454608|OG000|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
11237356|NCT02454608|OG001|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
11237357|NCT02454608|OG000|Outcome|Open Label|Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
11237358|NCT02454608|EG000|Reported Event|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
11237359|NCT02454608|EG001|Reported Event|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
11358596|NCT03621657|FG000|Participant Flow|Low Dose FMT Capsule DE|"FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic~Low Dose FMT Capsule DE: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course."
11358597|NCT03621657|FG001|Participant Flow|Placebo Oral Capsule|"Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic~Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment."
11358598|NCT03621657|FG002|Participant Flow|Single Dose FMT Capsule DE|"FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.~Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment."
11358599|NCT03621657|OG000|Outcome|Low Dose FMT Capsule DE|"FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic~Low Dose FMT Capsule DE: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course."
11358600|NCT03621657|OG001|Outcome|Placebo Oral Capsule|"Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic~Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment."
11358601|NCT03621657|OG002|Outcome|Single Dose FMT Capsule DE|"FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.~Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment."
11358602|NCT03621657|OG001|Outcome|Single Dose FMT Capsule DE|"FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.~Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment."
11358603|NCT03621657|OG002|Outcome|Placebo Oral Capsule|"Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic~Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment."
11358604|NCT03621657|EG000|Reported Event|Low Dose FMT Capsule DE|"FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic~Low Dose FMT Capsule DE: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course."
11358605|NCT03621657|EG001|Reported Event|Placebo Oral Capsule|"Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic~Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment."
11358606|NCT03621657|EG002|Reported Event|Single Dose FMT Capsule DE|"FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.~Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment."
11358607|NCT03615144|BG000|Baseline|Melphalan/Thiotepa/Clofarabine|"Melphalan 70 mg/m2/day x 2, Thiotepa 7.5 mg/kg/day x 2 and Clofarabine 20-30 mg/m2/day x 5. Patients will also receive rabbit anti-thymocyte globulin at 2.5 mg/kg/day x 3 doses prior to the start of conditioning.~Melphalan: Melphalan 70 mg/m2/day x 2~Thiotepa: Thiotepa 7.5 mg/kg/day x 2~Clofarabine: Clofarabine 20-30 mg/m2/day x 5~Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®): antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.~CliniMACS reagents: Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS."
11358608|NCT03615144|BG001|Baseline|Melphalan/Thiotepa/ Fludarabine|"Melphalan 70 mg/m2/day x 2, Thiotepa 7.5 mg/kg/day x 2 and Fludarabine 30 mg/m2/day x 5. Patients will also receive rabbit anti-thymocyte globulin at 2.5 mg/kg/day x 3 doses prior to the start of conditioning.~Melphalan: Melphalan 70 mg/m2/day x 2~Thiotepa: Thiotepa 7.5 mg/kg/day x 2~Fludarabine: Fludarabine 30 mg/m2/day x 5~Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®): antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.~CliniMACS reagents: Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS."
11358609|NCT03615144|BG002|Baseline|Total|Total of all reporting groups
11358610|NCT03615144|FG000|Participant Flow|Melphalan/Thiotepa/Clofarabine|"Melphalan 70 mg/m2/day x 2, Thiotepa 7.5 mg/kg/day x 2 and Clofarabine 20-30 mg/m2/day x 5. Patients will also receive rabbit anti-thymocyte globulin at 2.5 mg/kg/day x 3 doses prior to the start of conditioning.~Melphalan: Melphalan 70 mg/m2/day x 2~Thiotepa: Thiotepa 7.5 mg/kg/day x 2~Clofarabine: Clofarabine 20-30 mg/m2/day x 5~Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®): antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.~CliniMACS reagents: Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS."
11185774|NCT02096731|BG001|Baseline|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
11185775|NCT02096731|BG002|Baseline|Total|Total of all reporting groups
11185776|NCT02096731|FG000|Participant Flow|Tiotropium|Participants who were new users of tiotropium.
11376209|NCT01286272|OG000|Outcome|Arm A (Ofatumumab, Bendamustine Hydrochloride)|"INDUCTION: Patients receive:~300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.~MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses."
11185777|NCT02096731|FG001|Participant Flow|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
11185778|NCT02096731|OG000|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
11185779|NCT02096731|OG001|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
11185780|NCT02096731|OG000|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long-acting bronchodilator.
11185781|NCT02096731|OG001|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
11185782|NCT02096731|OG000|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long- acting bronchodilator.
11185783|NCT02096731|EG000|Reported Event|Tiotropium|Participants who were new users of tiotropium.
11185784|NCT02096731|EG001|Reported Event|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
11185785|NCT02096744|BG000|Baseline|Overall Study|"A randomised, double-blind, 2-way crossover design, followed by a period for assessment of adhesive properties of the clonidine patch.~In the crossover part of the trial, subjects were treated with either Catapres®-TTS delivering 0.3 mg clonidine/24 h (TTS-3) in the Oppanol® formulation (test treatment T1) or Catapres®-TTS-3 (0.3 mg/24 h) with Vistanex™ formulation (reference treatment R1) in each period. In the adhesion phase of the trial, subjects were treated simultaneously with Oppanol® (test treatment T2) and Vistanex™ (reference treatment R2) patches, each delivering 0.1 mg clonidine/24 h (TTS-1)."
11185786|NCT02096744|FG000|Participant Flow|Catapres®-TTS-3 Crossover 1: TTS-3 Oppanol Then TTS-3 Vistanex|Catapres®-TTS(Transdermal Therapeutic System)-3 (0.3 mg/24 hr) Oppanol® (T1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
11185787|NCT02096744|FG001|Participant Flow|Catapres®-TTS-3 Crossover 2: TTS-3 Vistanex Then TTS-3 Oppanol|Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Oppanol® (T1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
11185788|NCT02096744|OG000|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
11185789|NCT02096744|OG001|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
11185790|NCT02096744|OG001|Outcome|Catapres-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex™ (R1)
11185791|NCT02096744|EG000|Reported Event|TTS-3: Oppanol® (T1)|Administration of TTS-3 with Oppanol®
11185792|NCT02096744|EG001|Reported Event|TTS-3: Vistanex™ (R1)|Administration of TTS-3 with Vistanex™
11185793|NCT02096744|EG002|Reported Event|TTS-1: Vistanex™ (R2) + Oppanol® (T2)|Simultaneous administration of TTS-1 with Oppanol® and TTS-1 with Vistanex™
11185794|NCT02096835|BG000|Baseline|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
11185795|NCT02096835|BG001|Baseline|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
11185796|NCT02096835|BG002|Baseline|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
11185797|NCT02096835|BG003|Baseline|Total|Total of all reporting groups
11185798|NCT02096835|FG000|Participant Flow|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
11185799|NCT02096835|FG001|Participant Flow|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
11185800|NCT02096835|FG002|Participant Flow|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
11185801|NCT02096835|OG000|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
11358611|NCT03615144|FG001|Participant Flow|Melphalan/Thiotepa/ Fludarabine|"Melphalan 70 mg/m2/day x 2, Thiotepa 7.5 mg/kg/day x 2 and Fludarabine 30 mg/m2/day x 5. Patients will also receive rabbit anti-thymocyte globulin at 2.5 mg/kg/day x 3 doses prior to the start of conditioning.~Melphalan: Melphalan 70 mg/m2/day x 2~Thiotepa: Thiotepa 7.5 mg/kg/day x 2~Fludarabine: Fludarabine 30 mg/m2/day x 5~Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®): antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.~CliniMACS reagents: Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS."
11358612|NCT03615144|OG000|Outcome|Melphalan/Thiotepa/Clofarabine|"Melphalan 70 mg/m2/day x 2, Thiotepa 7.5 mg/kg/day x 2 and Clofarabine 20-30 mg/m2/day x 5. Patients will also receive rabbit anti-thymocyte globulin at 2.5 mg/kg/day x 3 doses prior to the start of conditioning.~Melphalan: Melphalan 70 mg/m2/day x 2~Thiotepa: Thiotepa 7.5 mg/kg/day x 2~Clofarabine: Clofarabine 20-30 mg/m2/day x 5~Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®): antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.~CliniMACS reagents: Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS."
11358613|NCT03615144|OG001|Outcome|Melphalan/Thiotepa/ Fludarabine|"Melphalan 70 mg/m2/day x 2, Thiotepa 7.5 mg/kg/day x 2 and Fludarabine 30 mg/m2/day x 5. Patients will also receive rabbit anti-thymocyte globulin at 2.5 mg/kg/day x 3 doses prior to the start of conditioning.~Melphalan: Melphalan 70 mg/m2/day x 2~Thiotepa: Thiotepa 7.5 mg/kg/day x 2~Fludarabine: Fludarabine 30 mg/m2/day x 5~Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®): antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.~CliniMACS reagents: Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS."
11358614|NCT03615144|EG000|Reported Event|Melphalan/Thiotepa/Clofarabine|"Melphalan 70 mg/m2/day x 2, Thiotepa 7.5 mg/kg/day x 2 and Clofarabine 20-30 mg/m2/day x 5. Patients will also receive rabbit anti-thymocyte globulin at 2.5 mg/kg/day x 3 doses prior to the start of conditioning.~Melphalan: Melphalan 70 mg/m2/day x 2~Thiotepa: Thiotepa 7.5 mg/kg/day x 2~Clofarabine: Clofarabine 20-30 mg/m2/day x 5~Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®): antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.~CliniMACS reagents: Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS."
11358615|NCT03615144|EG001|Reported Event|Melphalan/Thiotepa/ Fludarabine|"Melphalan 70 mg/m2/day x 2, Thiotepa 7.5 mg/kg/day x 2 and Fludarabine 30 mg/m2/day x 5. Patients will also receive rabbit anti-thymocyte globulin at 2.5 mg/kg/day x 3 doses prior to the start of conditioning.~Melphalan: Melphalan 70 mg/m2/day x 2~Thiotepa: Thiotepa 7.5 mg/kg/day x 2~Fludarabine: Fludarabine 30 mg/m2/day x 5~Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®): antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.~CliniMACS reagents: Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS."
11358616|NCT03605303|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into th study
11358617|NCT03605303|FG000|Participant Flow|Test/Control|Subjects that were radnomized to wear the Test lens during the period and the Control lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.
11358618|NCT03605303|FG001|Participant Flow|Control/Test|Subjects that were radnomized to wear the Control lens during the period and the Test lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.
11358619|NCT03605303|OG000|Outcome|Test|subjects that were randomized to receive the Test lens in either period of the study.
11358620|NCT03605303|OG001|Outcome|Control|All subject that were randomized to the Control lens during either period of the study.
11358621|NCT03605303|EG000|Reported Event|Test|Subjects that wore the Test lens during any time throughout the duration of the study.
11358622|NCT03605303|EG001|Reported Event|Control|Subjects that wore the Control lens during any time throughout the duration of the study.
11358623|NCT03600740|BG000|Baseline|GPi DBS|"Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue.~DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms."
11358624|NCT03600740|FG000|Participant Flow|GPi DBS|"Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue.~DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms."
11376210|NCT01286272|OG001|Outcome|Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)|"INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.~MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses."
11185802|NCT02096835|OG001|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
11358625|NCT03600740|OG000|Outcome|GPi DBS|"Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue.~DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms."
11185803|NCT02096835|OG002|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
11185804|NCT02096835|EG000|Reported Event|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
11185805|NCT02096835|EG001|Reported Event|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
11185806|NCT02096835|EG002|Reported Event|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
11185807|NCT02096861|BG000|Baseline|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185808|NCT02096861|BG001|Baseline|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185809|NCT02096861|BG002|Baseline|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185810|NCT02096861|BG003|Baseline|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185811|NCT02096861|BG004|Baseline|Total|Total of all reporting groups
11185812|NCT02096861|FG000|Participant Flow|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185813|NCT02096861|FG001|Participant Flow|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185814|NCT02096861|FG002|Participant Flow|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185815|NCT02096861|FG003|Participant Flow|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185816|NCT02096861|OG000|Outcome|CT-P13|CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
11185817|NCT02096861|OG001|Outcome|Remicade|Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
11185818|NCT02096861|OG000|Outcome|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185819|NCT02096861|OG001|Outcome|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185820|NCT02096861|OG002|Outcome|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185821|NCT02096861|OG003|Outcome|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185822|NCT02096861|EG000|Reported Event|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185823|NCT02096861|EG001|Reported Event|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11358626|NCT03600740|EG000|Reported Event|GPi DBS|"Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue.~DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms."
11358627|NCT03598140|BG000|Baseline|Placebo Oral Capsule|"If randomized to placebo, the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.~Placebo oral capsule: Placebo once (Group 1) or daily for 2 weeks (Group 2)"
11358628|NCT03598140|BG001|Baseline|Sildenafil Citrate|"If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.~Sildenafil Citrate: Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)"
11358629|NCT03598140|BG002|Baseline|Total|Total of all reporting groups
11358630|NCT03598140|FG000|Participant Flow|Placebo Oral Capsule|"If randomized to placebo, the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.~Placebo oral capsule: Placebo once (Group 1) or daily for 2 weeks (Group 2)"
11358631|NCT03598140|FG001|Participant Flow|Sildenafil Citrate|"If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.~Sildenafil Citrate: Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)"
11358632|NCT03598140|OG000|Outcome|Placebo Oral Capsule|"If randomized to placebo, the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.~Placebo oral capsule: Placebo once (Group 1) or daily for 2 weeks (Group 2)"
11358633|NCT03598140|OG001|Outcome|Sildenafil Citrate|"If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.~Sildenafil Citrate: Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)"
11358634|NCT03598140|EG000|Reported Event|Placebo Oral Capsule|"If randomized to placebo, the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.~Placebo oral capsule: Placebo once (Group 1) or daily for 2 weeks (Group 2)"
11358635|NCT03598140|EG001|Reported Event|Sildenafil Citrate|"If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.~Sildenafil Citrate: Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)"
11358636|NCT03598036|BG000|Baseline|Voclosporin Cohort 1|"Cohort 1:~Maximum dose of 3 capsules voclosporin (23.7 mg total) twice daily"
11358637|NCT03598036|BG001|Baseline|Voclosporin Cohort 2|"Trial ended prematurely before any patients were enrolled into Cohort 2~Cohort 2:~When Cohort 1 have completed 12 weeks of treatment with voclosporin, the top line efficacy and safety data will be analyzed to determine the dose level for Cohort 2. The selected dose may be higher or lower than 23.7 mg twice daily.~The maximum dose possible for Cohort 2 will be 39.5 mg (5 capsules) twice daily."
11358638|NCT03598036|BG002|Baseline|Total|Total of all reporting groups
11358639|NCT03598036|FG000|Participant Flow|Voclosporin Cohort 1|"Cohort 1:~Maximum dose of 3 capsules voclosporin (23.7 mg total) twice daily"
11358640|NCT03598036|FG001|Participant Flow|Voclosporin Cohort 2|"Trial ended prematurely before any patients were enrolled into Cohort 2~Cohort 2:~When Cohort 1 have completed 12 weeks of treatment with voclosporin, the top line efficacy and safety data will be analyzed to determine the dose level for Cohort 2. The selected dose may be higher or lower than 23.7 mg twice daily.~The maximum dose possible for Cohort 2 will be 39.5 mg (5 capsules) twice daily."
11358641|NCT03598036|OG000|Outcome|Voclosporin Cohort 1|"Cohort 1:~Maximum dose of 3 capsules voclosporin (23.7 mg total) twice daily"
11358642|NCT03598036|OG000|Outcome|Voclosporin Cohort 1|"Cohort 1:~Maximum dose of 3 capsules voclosporin (23.7mg total) twice daily"
11358643|NCT03598036|EG000|Reported Event|Voclosporin Cohort 1: Week 1|Cohort 1: Week 1 7.9 mg twice daily
11358644|NCT03598036|EG001|Reported Event|Voclosporin Cohort 1: Week 2|Cohort 1: Week 2 15.9 mg twice daily
11358645|NCT03598036|EG002|Reported Event|Voclosporin Cohort 1: Weeks 3-24|Cohort 1: Weeks 3-24 23.7 mg twice daily
11358646|NCT03598036|EG003|Reported Event|Voclosporin Cohort 2|"Trial ended prematurely before any patients were enrolled into Cohort 2~Cohort 2:~When Cohort 1 have completed 12 weeks of treatment with voclosporin, the top line efficacy and safety data will be analyzed to determine the dose level for Cohort 2. The selected dose may be higher or lower than 23.7 mg twice daily.~The maximum dose possible for Cohort 2 will be 39.5 mg (5 capsules) twice daily."
11358647|NCT03591458|BG000|Baseline|Amitriptyline|Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period.
11358648|NCT03591458|BG001|Baseline|Placebo|Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period.
11358649|NCT03591458|BG002|Baseline|Total|Total of all reporting groups
11358650|NCT03591458|FG000|Participant Flow|Amitriptyline|Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period.
11358651|NCT03591458|FG001|Participant Flow|Placebo|Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period.
11358652|NCT03591458|OG000|Outcome|Amitriptyline|"Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.~Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods."
11185824|NCT02096861|EG002|Reported Event|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185825|NCT02096861|EG003|Reported Event|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
11185826|NCT02096900|BG000|Baseline|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
11185827|NCT02096900|BG001|Baseline|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
11185828|NCT02096900|BG002|Baseline|Total|Total of all reporting groups
11185829|NCT02096900|FG000|Participant Flow|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
11185830|NCT02096900|FG001|Participant Flow|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
11185831|NCT02096900|OG000|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
11185832|NCT02096900|OG001|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
11185833|NCT02096900|EG000|Reported Event|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
11185834|NCT02096900|EG001|Reported Event|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
11185835|NCT02096952|BG000|Baseline|Methylphenidate Extended-release Liquid|"Methylphenidate extended-release liquid formulation (MPH-ERLF)~The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability."
11185836|NCT02096952|FG000|Participant Flow|Methylphenidate Extended-release Liquid|"Methylphenidate extended-release liquid formulation (MPH-ERLF)~The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability."
11185837|NCT02096952|OG000|Outcome|Methylphenidate Extended-release Liquid|Methylphenidate extended-release liquid formulation
11185838|NCT02096952|EG000|Reported Event|Methylphenidate Extended-release Liquid|Methylphenidate extended-release liquid formulation
11185839|NCT02097030|BG000|Baseline|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~etafilcon A: contact lens filcon II 3: contact lens"
11185840|NCT02097030|BG001|Baseline|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~nelfilcon A: contact lens filcon II 3: contact lens"
11185841|NCT02097030|BG002|Baseline|Total|Total of all reporting groups
11185842|NCT02097030|FG000|Participant Flow|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~etafilcon A: contact lens filcon II 3: contact lens"
11185843|NCT02097030|FG001|Participant Flow|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~nelfilcon A: contact lens filcon II 3: contact lens"
11185844|NCT02097030|OG000|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
11185845|NCT02097030|OG001|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
11185846|NCT02097030|OG002|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
11185847|NCT02097030|OG000|Outcome|Hydrogel|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.~(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
11185848|NCT02097030|OG001|Outcome|Filcon II 3|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.~(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
11185849|NCT02097030|EG000|Reported Event|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
11185850|NCT02097030|EG001|Reported Event|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
11185851|NCT02097030|EG002|Reported Event|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
11185852|NCT02097056|BG000|Baseline|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
11185853|NCT02097056|FG000|Participant Flow|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
11185854|NCT02097056|OG000|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
11185855|NCT02097056|EG000|Reported Event|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
11358653|NCT03591458|OG001|Outcome|Placebo|"Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.~Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods"
11358654|NCT03591458|EG000|Reported Event|Amitriptyline|Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period.
11358655|NCT03591458|EG001|Reported Event|Placebo|Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period.
11358656|NCT03590743|BG000|Baseline|Apixaban|"Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).~Apixaban: Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment."
11358657|NCT03590743|BG001|Baseline|Placebo|"Patients will receive matching placebo.~Placebo: apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months."
11358658|NCT03590743|BG002|Baseline|Total|Total of all reporting groups
11185856|NCT02097108|BG000|Baseline|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
11358659|NCT03590743|FG000|Participant Flow|Apixaban|"Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).~Apixaban: Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment."
11358660|NCT03590743|FG001|Participant Flow|Placebo|"Patients will receive matching placebo.~Placebo: apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months."
11358661|NCT03590743|OG000|Outcome|Apixaban|"Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).~Apixaban: Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment."
11358662|NCT03590743|OG001|Outcome|Placebo|"Patients will receive matching placebo.~Placebo: apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months."
11358663|NCT03590743|EG000|Reported Event|Apixaban|"Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).~Apixaban: Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment."
11358664|NCT03590743|EG001|Reported Event|Placebo|"Patients will receive matching placebo.~Placebo: apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months."
11358665|NCT03580382|BG000|Baseline|NRAS Mutant Melanoma|"C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)~Trametinib daily Until PD: 1.0 mg daily~CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W"
11358666|NCT03580382|BG001|Baseline|WT Melanoma|"C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)~Trametinib daily Until PD: 1.0 mg daily~CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W"
11358667|NCT03580382|BG002|Baseline|Total|Total of all reporting groups
11358668|NCT03580382|FG000|Participant Flow|NRAS Mutant Melanoma|"C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)~Trametinib daily Until PD: 1.0 mg daily~CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W"
11358669|NCT03580382|FG001|Participant Flow|WT Melanoma|"C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)~Trametinib daily Until PD: 1.0 mg daily~CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W"
11358670|NCT03580382|OG000|Outcome|NRAS Mutant Melanoma|"C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)~Trametinib daily Until PD: 1.0 mg daily~CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W"
11358671|NCT03580382|OG001|Outcome|WT Melanoma|"C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)~Trametinib daily Until PD: 1.0 mg daily~CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W"
11358672|NCT03580382|EG000|Reported Event|WT Melanoma|"C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)~Trametinib daily Until PD: 1.0 mg daily~CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W"
11358673|NCT03571646|BG000|Baseline|Capnostream 20|"Continuous monitoring of CO2~Capnostream 20 monitoring: Continuous monitoring on a general ward"
11358674|NCT03571646|BG001|Baseline|PM1000N-RR|"Continuous monitoring of SpO2~PM1000N-RR monitoring: Continuous monitoring on a general ward"
11358675|NCT03571646|BG002|Baseline|Total|Total of all reporting groups
11358676|NCT03571646|FG000|Participant Flow|Capnostream 20|"Continuous monitoring of CO2~Capnostream 20 monitoring: Continuous monitoring on a general ward"
11358677|NCT03571646|FG001|Participant Flow|PM1000N-RR|"Continuous monitoring of SpO2~PM1000N-RR monitoring: Continuous monitoring on a general ward"
11358678|NCT03571646|OG000|Outcome|Capnostream 20|"Continuous monitoring of CO2~Capnostream 20 monitoring: Continuous monitoring on a general ward"
11358679|NCT03571646|OG001|Outcome|PM1000N-RR|"Continuous monitoring of SpO2~PM1000N-RR monitoring: Continuous monitoring on a general ward"
11185857|NCT02097108|FG000|Participant Flow|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
11185858|NCT02097108|OG000|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
11185859|NCT02097108|EG000|Reported Event|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
11185860|NCT02097238|BG000|Baseline|Treatment (Eribulin Mesylate)|Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
11185861|NCT02097238|FG000|Participant Flow|Treatment (Eribulin Mesylate)|"Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Pharmacological Study: Correlative studies"
11185862|NCT02097238|OG000|Outcome|Treatment (Eribulin Mesylate)|Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
11185863|NCT02097238|OG000|Outcome|Treatment (Eribulin Mesylate)|"Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Pharmacological Study: Correlative studies"
11185864|NCT02097238|EG000|Reported Event|Treatment (Eribulin Mesylate)|Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
11185865|NCT02097277|BG000|Baseline|Treatment A: Placebo|Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks.
11185866|NCT02097277|BG001|Baseline|Treatment B: BMS-986036 (1 mg Daily)|BMS-986036 1 mg subcutaneous injection once daily for 12 weeks
11185867|NCT02097277|BG002|Baseline|Treatment C: BMS-986036 (5 mg Daily)|BMS-986036 5 mg subcutaneous injection once daily for 12 weeks.
11185868|NCT02097277|BG003|Baseline|Treatment D: BMS-986036 (20 mg Daily)|BMS-986036 20 mg subcutaneous injection once daily for 12 weeks.
11185869|NCT02097277|BG004|Baseline|Treatment E: BMS-986036 (20 mg Weekly)|BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks.
11185870|NCT02097277|BG005|Baseline|Total|Total of all reporting groups
11185871|NCT02097277|FG000|Participant Flow|Treatment A: Placebo|Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks.
11185872|NCT02097277|FG001|Participant Flow|Treatment B: BMS-986036 (1 mg Daily)|BMS-986036 1 mg subcutaneous injection once daily for 12 weeks.
11185873|NCT02097277|FG002|Participant Flow|Treatment C: BMS-986036 (5 mg Daily)|BMS-986036 5 mg subcutaneous injection once daily for 12 weeks.
11185874|NCT02097277|FG003|Participant Flow|Treatment D: BMS-986036 (20 mg Daily)|BMS-986036 20 mg subcutaneous injection once daily for 12 weeks.
11185875|NCT02097277|FG004|Participant Flow|Treatment E: BMS-986036 (20 mg Weekly)|BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks
11185876|NCT02097277|OG000|Outcome|Treatment A: Placebo|Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks.
11185877|NCT02097277|OG001|Outcome|Treatment B: BMS-986036 (1 mg Daily)|BMS-986036 1 mg subcutaneous injection once daily for 12 weeks.
11185878|NCT02097277|OG002|Outcome|Treatment C: BMS-986036 (5 mg Daily)|BMS-986036 5 mg subcutaneous injection once daily for 12 weeks.
11185879|NCT02097277|OG003|Outcome|Treatment D: BMS-986036 (20 mg Daily)|BMS-986036 20 mg subcutaneous injection once daily for 12 weeks.
11185880|NCT02097277|OG004|Outcome|Treatment E: BMS-986036 (20 mg Weekly)|BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks.
11185881|NCT02097277|OG000|Outcome|Treatment B: BMS-986036 (1 mg Daily)|BMS-986036 1 mg subcutaneous injection once daily for 12 weeks.
11185882|NCT02097277|OG001|Outcome|Treatment C: BMS-986036 (5 mg Daily)|BMS-986036 5 mg subcutaneous injection once daily for 12 weeks.
11185883|NCT02097277|OG002|Outcome|Treatment D: BMS-986036 (20 mg Daily)|BMS-986036 20 mg subcutaneous injection once daily for 12 weeks.
11185884|NCT02097277|OG003|Outcome|Treatment E: BMS-986036 (20 mg Weekly)|BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks.
11185885|NCT02097277|EG000|Reported Event|Treatment A: Placebo|Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks.
11185886|NCT02097277|EG001|Reported Event|Treatment B: BMS-986036 (1 mg Daily)|BMS-986036 1 mg subcutaneous injection once daily for 12 weeks.
11185887|NCT02097277|EG002|Reported Event|Treatment C: BMS-986036 (5 mg Daily)|BMS-986036 5 mg subcutaneous injection once daily for 12 weeks.
11185888|NCT02097277|EG003|Reported Event|Treatment D: BMS-986036 (20 mg Daily)|BMS-986036 20 mg subcutaneous injection once daily for 12 weeks.
11185889|NCT02097277|EG004|Reported Event|Treatment E: BMS-986036 (20 mg Weekly)|BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks.
11185890|NCT02097290|BG000|Baseline|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
11185891|NCT02097290|FG000|Participant Flow|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
11358680|NCT03571646|EG000|Reported Event|Capnostream 20|"Continuous monitoring of CO2~Capnostream 20 monitoring: Continuous monitoring on a general ward"
11185892|NCT02097290|OG000|Outcome|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
11185893|NCT02097290|EG000|Reported Event|CRT-D|"CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated.~Subjects in whom AUTOGEN CRT-D was successfully implanted or an attempt to implant made were considered to be at risk for adverse events. There were a total of 210 implants and attempts."
11185894|NCT02097303|BG000|Baseline|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
11185895|NCT02097303|FG000|Participant Flow|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
11185896|NCT02097303|OG000|Outcome|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
11185897|NCT02097303|EG000|Reported Event|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
11185898|NCT02097472|BG000|Baseline|Adult Cohort: PATH-wSP (600 mcg)|A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.
11185899|NCT02097472|BG001|Baseline|Adult Cohort: PATH-wSP (1000 mcg)|A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.
11185900|NCT02097472|BG002|Baseline|Adult Cohort: Saline|A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.
11185901|NCT02097472|BG003|Baseline|Toddler Cohort: PATH-wSP (300 mcg)+Active Control|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185902|NCT02097472|BG004|Baseline|Toddler Cohort: PATH-wSP (300 mcg)+Saline|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185903|NCT02097472|BG005|Baseline|Toddler Cohort: PATH-wSP (600 mcg)+Active Control|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185904|NCT02097472|BG006|Baseline|Toddler Cohort: PATH-wSP (600 mcg)+Saline|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185905|NCT02097472|BG007|Baseline|Toddler Cohort: Active Control Only|A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
11185906|NCT02097472|BG008|Baseline|Total|Total of all reporting groups
11185907|NCT02097472|FG000|Participant Flow|Adult Cohort 1: PATH-wSP (600 mcg)|A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.
11185908|NCT02097472|FG001|Participant Flow|Adult Cohort 2: PATH-wSP (1000 mcg)|A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.
11185909|NCT02097472|FG002|Participant Flow|Adult Cohort: Saline|A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.
11185910|NCT02097472|FG003|Participant Flow|Toddler Cohort 1: PATH-wSP (300 mcg)+Active Control|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185911|NCT02097472|FG004|Participant Flow|Toddler Cohort 1: PATH-wSP (300 mcg)+Saline|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185912|NCT02097472|FG005|Participant Flow|Toddler Cohort 2: PATH-wSP (600 mcg)+Active Control|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185913|NCT02097472|FG006|Participant Flow|Toddler Cohort 2: PATH-wSP (600 mcg)+Saline|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11358681|NCT03571646|EG001|Reported Event|PM1000N-RR|"Continuous monitoring of SpO2~PM1000N-RR monitoring: Continuous monitoring on a general ward"
11185914|NCT02097472|FG007|Participant Flow|Toddler Cohort: Active Control Only|A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
11185915|NCT02097472|OG000|Outcome|PATH-wSP (600 mcg): Vaccination 1|A single injection of 600 mcg PATH-wSP in one arm
11358682|NCT03565328|BG000|Baseline|Nicotinamide Riboside in Patients With Stable Heart Failure|Nicotinamide Riboside (NR) will be started at 500 mg daily (250 mg BID) then increased at two weekly intervals by 250 mg/dose (BID) (500 mg/day) to a final dose of 1000 mg PO BID (2000 mg/day) in patients with stable, systolic heart failure.
11358683|NCT03565328|FG000|Participant Flow|Nicotinamide Riboside in Patients With Stable Heart Failure|Nicotinamide Riboside (NR) will be started at 500 mg daily (250 mg BID) then increased at two weekly intervals by 250 mg/dose (BID) (500 mg/day) to a final dose of 1000 mg PO BID (2000 mg/day) in patients with stable, systolic heart failure.
11185916|NCT02097472|OG001|Outcome|PATH-wSP (1000 mcg): Vaccination 1|A single injection of 1000 mcg PATH-wSP in one arm
11185917|NCT02097472|OG002|Outcome|Saline: Vaccination 1|A single injection of saline in one arm.
11185918|NCT02097472|OG003|Outcome|PATH-wSP (600 mcg): Vaccination 2|Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection
11185919|NCT02097472|OG004|Outcome|PATH-wSP (1000 mcg): Vaccination 2|Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection
11185920|NCT02097472|OG005|Outcome|Saline: Vaccination 2|A single injection of saline in one arm, one month after initial injection
11185921|NCT02097472|OG000|Outcome|PATH-wSP (300 mcg)+Active Control: Vaccination 1|A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
11185922|NCT02097472|OG001|Outcome|PATH-wSP (300 mcg)+Saline: Vaccination 1|Single injection of 1000 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.
11185923|NCT02097472|OG002|Outcome|PATH-wSP (600 mcg)+Active Control: Vaccination 1|A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
11185924|NCT02097472|OG003|Outcome|PATH-wSP (600 mcg)+Saline: Vaccination 1|Single injection of 600 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.
11185925|NCT02097472|OG004|Outcome|Active Control Only: Vaccination 1|A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
11185926|NCT02097472|OG005|Outcome|PATH-wSP (300 mcg): Vaccination 2|A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
11185927|NCT02097472|OG006|Outcome|PATH-wSP (600 mcg): Vaccination 2|A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
11185928|NCT02097472|OG007|Outcome|Saline: Vaccination 2|A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.
11185929|NCT02097472|OG000|Outcome|300 mcg PATH-wSP: Vaccination 1|A single injection of 300 mcg PATH-wSP in the left thigh at first vaccination (during which subjects also received either two saline injections, or or Synflorix and Pentavac injections, in the right thigh)
11185930|NCT02097472|OG001|Outcome|600 mcg PATH-wSP: Vaccination 1|A single injection of 600 mcg PATH-wSP in the left thigh (during which subjects also received either two saline injections, or or Synflorix and Pentavac injections, in the right thigh)
11185931|NCT02097472|OG002|Outcome|Active Control: Pentavac|A single injection of the active comparator vaccine Pentavac in the right thigh during the first vaccination.
11185932|NCT02097472|OG003|Outcome|Active Control: Synflorix|A single injection of the active comparator vaccine Synflorix in the right thigh during the first vaccination.
11185933|NCT02097472|OG004|Outcome|Active Control: Saline|One injection of saline in the left thigh during the first vaccination (during which subjects received Pentavac and Synflorix injections, but no PATH-wSP injections)
11185934|NCT02097472|OG005|Outcome|PATH-wSP (300 mcg): Vaccination 2|SA single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
11185935|NCT02097472|OG000|Outcome|Adult Cohort: PATH-wSP (600 mcg)|A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.
11185936|NCT02097472|OG001|Outcome|Adult Cohort: PATH-wSP (1000 mcg)|A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.
11185937|NCT02097472|OG002|Outcome|Adult Cohort: Saline|A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.
11185938|NCT02097472|OG003|Outcome|Toddler Cohort: PATH-wSP (300 mcg)+Active Control|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185939|NCT02097472|OG004|Outcome|Toddler Cohort: PATH-wSP (300 mcg)+Saline|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185940|NCT02097472|OG005|Outcome|Toddler Cohort: PATH-wSP (600 mcg)+Active Control|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185941|NCT02097472|OG006|Outcome|Toddler Cohort: PATH-wSP (600 mcg)+Saline|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11237360|NCT02454608|EG002|Reported Event|Open Label|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
11237361|NCT02454959|BG000|Baseline|MITT Population|The Modified ITT (MITT) Population is a subset of the ITT Population including subjects who received treatment and had post dose efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations were determined prior to unblinding and excluded. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment have been excluded from the affected periods.
11237362|NCT02454959|FG000|Participant Flow|Overall Study|All Randomized Patients
11237363|NCT02454959|OG000|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
11237364|NCT02454959|OG001|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
11237365|NCT02454959|EG000|Reported Event|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
11237366|NCT02454959|EG001|Reported Event|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
11237367|NCT02454972|BG000|Baseline|Biliary Tract Carcinoma Cohort|Patients with Pathologically proven diagnosis of biliary tract carcinoma
11237368|NCT02454972|BG001|Baseline|Carcinoma of Unknown Primary Site Cohort|Patients with pathologically proven diagnosis of carcinoma of unknown primary site
11237369|NCT02454972|BG002|Baseline|Endometrial Carcinoma Cohort|Patients with pathologically proven diagnosis of endometrial carcinoma
11237370|NCT02454972|BG003|Baseline|Ewing's Family of Tumors Cohort|Patients with pathologically proven diagnosis of Ewing's Family of Tumors
11237371|NCT02454972|BG004|Baseline|Germ Cell Tumors Cohort|Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
11237372|NCT02454972|BG005|Baseline|Head and Neck Carcinoma Cohort|Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
11237373|NCT02454972|BG006|Baseline|BRCA1/2-associated Metastatic Breast Carcinoma Cohort|Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
11237374|NCT02454972|BG007|Baseline|Neuroendocrine Tumors Cohort|Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
11237375|NCT02454972|BG008|Baseline|Small Cell Lung Cancer Cohort|Patients with pathologically proven diagnosis of small cell lung cancer
11237376|NCT02454972|BG009|Baseline|Total|Total of all reporting groups
11237377|NCT02454972|FG000|Participant Flow|Biliary Tract Carcinoma Cohort|"Patients with Pathologically proven diagnosis of biliary tract carcinoma~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237378|NCT02454972|FG001|Participant Flow|Carcinoma of Unknown Primary Site Cohort|"Patients with pathologically proven diagnosis of carcinoma of unknown primary site~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237379|NCT02454972|FG002|Participant Flow|Endometrial Carcinoma Cohort|"Patients with pathologically proven diagnosis of endometrial carcinoma~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237380|NCT02454972|FG003|Participant Flow|Ewing's Family of Tumors Cohort|"Patients with pathologically proven diagnosis of Ewing's Family of Tumors~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11358684|NCT03565328|OG000|Outcome|Nicotinamide Riboside in Patients With Stable Heart Failure|Nicotinamide Riboside (NR) will be started at 500 mg daily (250 mg BID) then increased at two weekly intervals by 250 mg/dose (BID) (500 mg/day) to a final dose of 1000 mg PO BID (2000 mg/day) in patients with stable, systolic heart failure.
11358685|NCT03565328|EG000|Reported Event|Nicotinamide Riboside in Patients With Stable Heart Failure|Nicotinamide Riboside (NR) will be started at 500 mg daily (250 mg BID) then increased at two weekly intervals by 250 mg/dose (BID) (500 mg/day) to a final dose of 1000 mg PO BID (2000 mg/day) in patients with stable, systolic heart failure.
11358686|NCT03544242|BG000|Baseline|Control Group|Control: A saline infusion will be administered during the pre-isolation and post-isolation phases.
11358687|NCT03544242|BG001|Baseline|Pre-Isolation Infusion|Pre-Isolation Infusion: A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.
11358688|NCT03544242|BG002|Baseline|Post-Isolation Infusion|Post-Isolation Infusion: A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
11358689|NCT03544242|BG003|Baseline|Total|Total of all reporting groups
11358690|NCT03544242|FG000|Participant Flow|Control Group|Control: A saline infusion will be administered during the pre-isolation and post-isolation phases.
11358691|NCT03544242|FG001|Participant Flow|Pre-Isolation Infusion|Pre-Isolation Infusion: A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.
11358692|NCT03544242|FG002|Participant Flow|Post-Isolation Infusion|Post-Isolation Infusion: A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
11358693|NCT03544242|OG000|Outcome|Control Group|Control: A saline infusion will be administered during the pre-isolation and post-isolation phases.
11358694|NCT03544242|OG001|Outcome|Pre-Isolation Infusion|Pre-Isolation Infusion: A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.
11358695|NCT03544242|OG002|Outcome|Post-Isolation Infusion|Post-Isolation Infusion: A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
11358696|NCT03544242|EG000|Reported Event|Control Group|Control: A saline infusion will be administered during the pre-isolation and post-isolation phases.
11358697|NCT03544242|EG001|Reported Event|Pre-Isolation Infusion|Pre-Isolation Infusion: A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.
11358698|NCT03544242|EG002|Reported Event|Post-Isolation Infusion|Post-Isolation Infusion: A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
11358699|NCT03543358|BG000|Baseline|Arm A: Post-Treatment Follow-Up/Optional Retreatment|Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).
11358700|NCT03543358|FG000|Participant Flow|Arm A: Post-Treatment Follow-Up/Optional Retreatment|Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).
11358701|NCT03543358|FG001|Participant Flow|Arm B: Continued Treatment|Participants who entered the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study. Participants receive rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.
11358702|NCT03543358|OG000|Outcome|Arm A: Post-Treatment Follow-Up/Optional Retreatment|Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).
11358703|NCT03543358|EG000|Reported Event|Arm A: Post-Treatment Follow-Up/Optional Retreatment|Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).
11358704|NCT03538015|BG000|Baseline|Carvedilol 3.125 mg|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Carvedilol 3.125 mg: Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period"
11358705|NCT03538015|BG001|Baseline|Carvedilol 2.5 mg|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Carvedilol 2.5 mg: Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period"
11358706|NCT03538015|BG002|Baseline|Placebo Capsule|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of placebo treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Placebo capsule: Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period"
11358707|NCT03538015|BG003|Baseline|Total|Total of all reporting groups
11185942|NCT02097472|OG007|Outcome|Toddler Cohort: Active Control Only|A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
11185943|NCT02097472|OG000|Outcome|Toddler Cohort: PATH-wSP (300 mcg)+Active Control|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185944|NCT02097472|OG001|Outcome|Toddler Cohort: PATH-wSP (300 mcg)+Saline|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185945|NCT02097472|OG002|Outcome|Toddler Cohort: PATH-wSP (600 mcg)+Active Control|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185946|NCT02097472|OG003|Outcome|Toddler Cohort: PATH-wSP (600 mcg)+Saline|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185947|NCT02097472|OG004|Outcome|Toddler Cohort: Active Control Only|A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
11185948|NCT02097472|OG001|Outcome|PATH-wSP (300 mcg)+Saline: Vaccination 1|Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.
11185949|NCT02097472|OG005|Outcome|PATH-wSP (300 mcg)+Active Control: Vaccination 2|A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
11185950|NCT02097472|OG006|Outcome|PATH-wSP (300 mcg)+Saline: Vaccination 2|Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
11185951|NCT02097472|OG007|Outcome|PATH-wSP (600 mcg)+Active Control: Vaccination 2|A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
11185952|NCT02097472|OG008|Outcome|PATH-wSP (600 mcg)+Saline: Vaccination 2|A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
11185953|NCT02097472|OG009|Outcome|Active Control Only: Vaccination 2|A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
11185954|NCT02097472|OG000|Outcome|PATH-wSP (600 mcg): Baseline|Subjects receiving 600 mcg PATH-wSP: levels pre-vaccination
11185955|NCT02097472|OG001|Outcome|PATH-wSP (600 mcg): Vaccination 1|Subjects receiving 600 mcg PATH-wSP: levels after first vaccination
11185956|NCT02097472|OG002|Outcome|PATH-wSP (600 mcg): Vaccination 2|Subjects receiving 600 mcg PATH-wSP: levels after second vaccination
11185957|NCT02097472|OG003|Outcome|PATH-wSP (1000 mcg): Baseline|Subjects receiving 1000 mcg PATH-wSP: levels pre-vaccination
11185958|NCT02097472|OG004|Outcome|PATH-wSP (1000 mcg): Vaccination 1|Subjects receiving 1000 mcg PATH-wSP: levels after first vaccination
11185959|NCT02097472|OG005|Outcome|PATH-wSP (1000 mcg): Vaccination 2|Subjects receiving 1000 mcg PATH-wSP: levels after second vaccination
11185960|NCT02097472|OG006|Outcome|Saline: Baseline|Subjects receiving saline placebo injection: levels pre-vaccination
11185961|NCT02097472|OG007|Outcome|Saline: Vaccination 1|Subjects receiving saline placebo injection: levels after vaccination 1
11185962|NCT02097472|OG008|Outcome|Saline: Vaccination 2|Subjects receiving saline placebo injection: levels after vaccination 2
11185963|NCT02097472|OG000|Outcome|PATH-wSP (300 mcg)+Active Control: Baseline|Subjects receiving 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination
11185964|NCT02097472|OG001|Outcome|PATH-wSP (300 mcg)+Active Control: Vaccination 1|Subjects receiving 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1
11185965|NCT02097472|OG002|Outcome|PATH-wSP (300 mcg)+Active Control: Vaccination 2|Subjects receiving 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
11185966|NCT02097472|OG003|Outcome|PATH-wSP (300 mcg)+Saline: Baseline|Subjects receiving 300 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: pre-vaccination
11185967|NCT02097472|OG004|Outcome|PATH-wSP (300 mcg)+Saline: Vaccination 1|Subjects receiving 300 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after vaccination 1
11185968|NCT02097472|OG005|Outcome|PATH-wSP (300 mcg)+Saline: Vaccination 2|Subjects receiving 300 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after vaccination 2
11185969|NCT02097472|OG006|Outcome|PATH-wSP (600 mcg)+Active Control: Baseline|Subjects receiving 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination
11185970|NCT02097472|OG007|Outcome|PATH-wSP (600 mcg)+Active Control: Vaccination 1|Subjects receiving 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1
11185971|NCT02097472|OG008|Outcome|PATH-wSP (600 mcg)+Active Control: Vaccination 2|Subjects receiving 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
11185972|NCT02097472|OG009|Outcome|PATH-wSP (600 mcg)+Saline: Baseline|Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: pre-vaccination
11237381|NCT02454972|FG004|Participant Flow|Germ Cell Tumors Cohort|"Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237382|NCT02454972|FG005|Participant Flow|Head and Neck Carcinoma Cohort|"Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237383|NCT02454972|FG006|Participant Flow|BRCA1/2-associated Metastatic Breast Carcinoma Cohort|"Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237384|NCT02454972|FG007|Participant Flow|Neuroendocrine Tumors Cohort|"Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237385|NCT02454972|FG008|Participant Flow|Small Cell Lung Cancer Cohort|"Patients with pathologically proven diagnosis of small cell lung cancer~Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237386|NCT02454972|OG000|Outcome|Biliary Tract Carcinoma Cohort|Patients with Pathologically proven diagnosis of biliary tract carcinoma
11237387|NCT02454972|OG001|Outcome|Carcinoma of Unknown Primary Site Cohort|Patients with pathologically proven diagnosis of carcinoma of unknown primary site
11237388|NCT02454972|OG002|Outcome|Endometrial Carcinoma Cohort|Patients with pathologically proven diagnosis of endometrial carcinoma
11237389|NCT02454972|OG003|Outcome|Ewing's Family of Tumors Cohort|Patients with pathologically proven diagnosis of Ewing's Family of Tumors
11237390|NCT02454972|OG004|Outcome|Germ Cell Tumors Cohort|Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
11237391|NCT02454972|OG005|Outcome|Head and Neck Carcinoma Cohort|Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
11237392|NCT02454972|OG006|Outcome|BRCA1/2-associated Metastatic Breast Carcinoma Cohort|Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
11237393|NCT02454972|OG007|Outcome|Neuroendocrine Tumors Cohort|Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
11237394|NCT02454972|OG008|Outcome|Small Cell Lung Cancer Cohort|Patients with pathologically proven diagnosis of small cell lung cancer
11237395|NCT02454972|EG000|Reported Event|Lurbinectedin (PM01183)|"Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m2. Dose was capped at body surface area (BSA) of 2.0 m2 (i.e., dose did not exceed 6.4 mg).~Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle)."
11237396|NCT02455050|BG000|Baseline|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237397|NCT02455050|BG001|Baseline|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237398|NCT02455050|BG002|Baseline|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237399|NCT02455050|BG003|Baseline|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237400|NCT02455050|BG004|Baseline|Total|Total of all reporting groups
11358708|NCT03538015|FG000|Participant Flow|Carvedilol 3.125 mg|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Carvedilol 3.125 mg: Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period"
11358709|NCT03538015|FG001|Participant Flow|Carvedilol 2.5 mg|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Carvedilol 2.5 mg: Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period"
11358710|NCT03538015|FG002|Participant Flow|Placebo Capsule|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of placebo treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Placebo capsule: Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period"
11358711|NCT03538015|OG000|Outcome|Carvedilol 3.125 mg|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Carvedilol 3.125 mg: Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period"
11358712|NCT03538015|OG001|Outcome|Carvedilol 2.5 mg|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Carvedilol 2.5 mg: Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period"
11358713|NCT03538015|OG002|Outcome|Placebo Capsule|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of placebo treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Placebo capsule: Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period"
11358714|NCT03538015|EG000|Reported Event|Carvedilol 3.125 mg|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Carvedilol 3.125 mg: Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period"
11358715|NCT03538015|EG001|Reported Event|Carvedilol 2.5 mg|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Carvedilol 2.5 mg: Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period"
11358716|NCT03538015|EG002|Reported Event|Placebo Capsule|"After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of placebo treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.~Placebo capsule: Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period"
11358717|NCT03534362|BG000|Baseline|Nasopore Group|"Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.~Nasopore: Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract~Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant."
11358718|NCT03534362|BG001|Baseline|Propel Stent Group|"Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.~Propel: Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.~Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant."
11358719|NCT03534362|BG002|Baseline|Total|Total of all reporting groups
11358720|NCT03534362|FG000|Participant Flow|Nasopore Group|"Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.~Nasopore: Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract~Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant."
11358721|NCT03534362|FG001|Participant Flow|Propel Stent Group|"Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.~Propel: Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.~Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant."
11358722|NCT03534362|OG000|Outcome|Nasopore Group|"Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.~Nasopore: Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract~Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant."
11358723|NCT03534362|OG001|Outcome|Propel Stent Group|"Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.~Propel: Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.~Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant."
11358724|NCT03534362|OG000|Outcome|Nasopore Group|"Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.~Nasopore: Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract"
11358725|NCT03534362|OG001|Outcome|Propel Stent Group|"Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.~Propel: Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract."
11358726|NCT03534362|EG000|Reported Event|Nasopore Group|"Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.~Nasopore: Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract"
11358727|NCT03534362|EG001|Reported Event|Propel Stent Group|"Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.~Propel: Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract."
11358728|NCT03509207|BG000|Baseline|Vorinostat, Zolinza Oral Capsules|"Vorinostat Oral Capsules 400mg daily~Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months."
11358729|NCT03509207|FG000|Participant Flow|Vorinostat, Zolinza Oral Capsules|"Vorinostat Oral Capsules 400mg daily~Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months."
11358730|NCT03509207|OG000|Outcome|Vorinostat, Zolinza Oral Capsules|"Vorinostat Oral Capsules 400mg daily~Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months."
11358731|NCT03509207|EG000|Reported Event|Vorinostat, Zolinza Oral Capsules|"Vorinostat Oral Capsules 400mg daily~Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months."
11358732|NCT03505372|BG000|Baseline|Contrast Enhanced Mammography|"The CESM images will be performed according to clinical protocol~Images will be acquired within approximately 2-12 minutes of contrast injection~A total of four images per breast will be acquired with low and high energy~Two radiologists will prospectively review the CESM, and will use a third as tie-breaker~The CESM will be evaluated for the biopsy site and up to two additional findings in either breast~The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement~Contrast enhanced mammography: Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone."
11358733|NCT03505372|FG000|Participant Flow|Contrast Enhanced Mammography|"The CESM images will be performed according to clinical protocol~Images will be acquired within approximately 2-12 minutes of contrast injection~A total of four images per breast will be acquired with low and high energy~Two radiologists will prospectively review the CESM, and will use a third as tie-breaker~The CESM will be evaluated for the biopsy site and up to two additional findings in either breast~The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement~Contrast enhanced mammography: Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone."
11237401|NCT02455050|FG000|Participant Flow|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237402|NCT02455050|FG001|Participant Flow|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237403|NCT02455050|FG002|Participant Flow|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237404|NCT02455050|FG003|Participant Flow|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237405|NCT02455050|OG000|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
11237406|NCT02455050|OG001|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
11237407|NCT02455050|OG002|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
11237408|NCT02455050|OG003|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
11237409|NCT02455050|OG000|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237410|NCT02455050|OG001|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237411|NCT02455050|OG002|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237412|NCT02455050|OG003|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11358734|NCT03505372|OG000|Outcome|Contrast Enhanced Mammography|"The CESM images will be performed according to clinical protocol~Images will be acquired within approximately 2-12 minutes of contrast injection~A total of four images per breast will be acquired with low and high energy~Two radiologists will prospectively review the CESM, and will use a third as tie-breaker~The CESM will be evaluated for the biopsy site and up to two additional findings in either breast~The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement~Contrast enhanced mammography: Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone."
11237413|NCT02455050|OG000|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237414|NCT02455050|OG001|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237415|NCT02455050|OG002|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
11237416|NCT02455050|OG003|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
11237417|NCT02455050|OG000|Outcome|New Eye Drop Formulation and Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
11237418|NCT02455050|OG000|Outcome|New Eye Drop Formulation and Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Genteal® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
11237419|NCT02455050|EG000|Reported Event|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237420|NCT02455050|EG001|Reported Event|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237421|NCT02455050|EG002|Reported Event|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237422|NCT02455050|EG003|Reported Event|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
11237423|NCT02455076|BG000|Baseline|Exenatide Inpatient|Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
11237424|NCT02455076|BG001|Baseline|Exenatide Plus Glargine Insulin Inpatient|"Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response.~Glargine: Glargine will be given once daily, at the same time of day."
11237425|NCT02455076|BG002|Baseline|Basal Bolus Regimen Inpatient|Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.
11237426|NCT02455076|BG003|Baseline|Exenatide Outpatient|Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
11237427|NCT02455076|BG004|Baseline|Insulin Only Outpatient|patients will be treated with Insulin only
11237428|NCT02455076|BG005|Baseline|Total|Total of all reporting groups
11237429|NCT02455076|FG000|Participant Flow|Exenatide Inpatient|Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
11237430|NCT02455076|FG001|Participant Flow|Exenatide Plus Glargine Insulin Inpatient|"Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response.~Glargine: Glargine will be given once daily, at the same time of day."
11237431|NCT02455076|FG002|Participant Flow|Basal Bolus Regimen Inpatient|Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.
11237432|NCT02455076|FG003|Participant Flow|Exenatide Outpatient|Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
11237433|NCT02455076|FG004|Participant Flow|Insulin Only Outpatient|Patients are treated with insulin only
11237434|NCT02455076|OG000|Outcome|Exenatide|Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
11237435|NCT02455076|OG001|Outcome|Exenatide Plus Glargine Insulin|"Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response.~Glargine: Glargine will be given once daily, at the same time of day."
11237436|NCT02455076|OG002|Outcome|Basal Bolus Regimen|Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.
11237437|NCT02455076|OG000|Outcome|Exenatide Outpatient|Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
11237438|NCT02455076|OG001|Outcome|Insulin Only Outpatient|Patients are treated with insulin only
11237439|NCT02455076|EG000|Reported Event|Exenatide Inpatient|Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
11237440|NCT02455076|EG001|Reported Event|Exenatide Plus Glargine Insulin Inpatient|"Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response.~Glargine: Glargine will be given once daily, at the same time of day."
11237441|NCT02455076|EG002|Reported Event|Basal Bolus Regimen Inpatient|Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.
11237442|NCT02455076|EG003|Reported Event|Exenatide Outpatient|Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
11237443|NCT02455076|EG004|Reported Event|Insulin Only Outpatient|Patients with Type 2 Diabetes treated with Insulin only
11185973|NCT02097472|OG010|Outcome|PATH-wSP (600 mcg)+Saline: Vaccination 1|Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1
11185974|NCT02097472|OG011|Outcome|PATH-wSP (600 mcg)+Saline: Vaccination 2|Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2
11185975|NCT02097472|OG012|Outcome|Active Control Only: Baseline|Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination
11185976|NCT02097472|OG013|Outcome|Active Control Only: Vaccination 1|Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1
11185977|NCT02097472|OG014|Outcome|Active Control Only: Vaccination 2|Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
11185978|NCT02097472|OG000|Outcome|Cohort 1: PATH-wSP 300 mcg+Active Control|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185979|NCT02097472|OG001|Outcome|Cohort 1: PATH-wSP 300 mcg+Saline|"A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum~Saline: 0.9% Sodium Chloride Injection, USP"
11185980|NCT02097472|OG002|Outcome|Cohort 1: Active Control Only|A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
11185981|NCT02097472|OG003|Outcome|Cohort 2 PATH-wSP 600 mcg+Active Control|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185982|NCT02097472|OG004|Outcome|Cohort 2: PATH-wSP 600 mcg+Saline|"A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum~Saline: 0.9% Sodium Chloride Injection, USP"
11185983|NCT02097472|OG005|Outcome|Cohort 2: Active Control Only|"A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.~Synflorix: 1 dose (0.5 mL) contains:~1 μg of each of the following pneumococcal polysaccharide serotypes:~1, 5, 6B, 7F, 9V, 14, and 23 F~And 3 μg of the following pneumococcal polysaccharide serotypes:~4, 18C and 19F.~The serotypes are conjugated to either:~protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein~Pentavac: Each PFS contains 0.5 ml (single dose):~Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 %~Dose:"
11185984|NCT02097472|OG000|Outcome|PATH-wSP 300 mcg+Active Control|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185985|NCT02097472|OG001|Outcome|PATH-wSP 300 mcg+Saline|"A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum~Saline: 0.9% Sodium Chloride Injection, USP"
11185986|NCT02097472|OG002|Outcome|PATH-wSP 600 mcg+Active Control|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185987|NCT02097472|OG003|Outcome|PATH-wSP 600 mcg+Saline|"A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum~Saline: 0.9% Sodium Chloride Injection, USP"
11185988|NCT02097472|OG004|Outcome|Active Control Only|"A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.~Synflorix: 1 dose (0.5 mL) contains:~1 μg of each of the following pneumococcal polysaccharide serotypes:~1, 5, 6B, 7F, 9V, 14, and 23 F~And 3 μg of the following pneumococcal polysaccharide serotypes:~4, 18C and 19F.~The serotypes are conjugated to either:~protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein~Pentavac: Each PFS contains 0.5 ml (single dose):~Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 %~Dose:"
11185989|NCT02097472|EG000|Reported Event|Adult Cohort: PATH-wSP (600 mcg)|A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.
11185990|NCT02097472|EG001|Reported Event|Adult Cohort: PATH-wSP (1000 mcg)|A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.
11185991|NCT02097472|EG002|Reported Event|Adult Cohort: Saline|A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.
11185992|NCT02097472|EG003|Reported Event|Toddler Cohort: PATH-wSP (300 mcg)+Active Control|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185993|NCT02097472|EG004|Reported Event|Toddler Cohort: PATH-wSP (300 mcg)+Saline|A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.
11185994|NCT02097472|EG005|Reported Event|Toddler Cohort: PATH-wSP (600 mcg)+Active Control|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185995|NCT02097472|EG006|Reported Event|Toddler Cohort: PATH-wSP (600 mcg)+Saline|A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.
11185996|NCT02097472|EG007|Reported Event|Toddler Cohort: Active Control Only|A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
11185997|NCT02097485|BG000|Baseline|Abametapir Lotion 0.74% w/w|"Topically administered to hair and scalp for 10 minutes application.~Abametapir Lotion 0.74% w/w: 200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water."
11185998|NCT02097485|BG001|Baseline|Vehicle Lotion|"Administered to scalp and hair for 10 minutes application.~Vehicle Lotion: control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water."
11185999|NCT02097485|BG002|Baseline|Total|Total of all reporting groups
11186000|NCT02097485|FG000|Participant Flow|Abametapir Lotion 0.74% w/w|"Topically administered to hair and scalp for 10 minutes application.~Abametapir Lotion 0.74% w/w: 200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water."
11186001|NCT02097485|FG001|Participant Flow|Vehicle Lotion|"Administered to scalp and hair for 10 minutes application.~Vehicle Lotion: control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water."
11186002|NCT02097485|OG000|Outcome|Abametapir Lotion 0.74% w/w|"Topically administered to hair and scalp for 10 minutes application.~Abametapir Lotion 0.74% w/w: 200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water."
11186003|NCT02097485|OG001|Outcome|Vehicle Lotion|"Administered to scalp and hair for 10 minutes application.~Vehicle Lotion: control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water."
11186004|NCT02097485|EG000|Reported Event|Abametapir Lotion 0.74% w/w|"Topically administered to hair and scalp for 10 minutes application.~Abametapir Lotion 0.74% w/w: 200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water."
11186005|NCT02097485|EG001|Reported Event|Vehicle Lotion|"Administered to scalp and hair for 10 minutes application.~Vehicle Lotion: control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water."
11186006|NCT02097537|BG000|Baseline|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
11186007|NCT02097537|FG000|Participant Flow|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
11186008|NCT02097537|OG000|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
11186009|NCT02097537|EG000|Reported Event|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
11186010|NCT02097641|BG000|Baseline|Human Mesenchymal Stem Cells (hMSCs)|"A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.~Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes."
11186011|NCT02097641|BG001|Baseline|Plasma-Lyte A (Placebo)|"A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.~Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes."
11186012|NCT02097641|BG002|Baseline|Total|Total of all reporting groups
11186013|NCT02097641|FG000|Participant Flow|Human Mesenchymal Stem Cells|"A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.~Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes."
11186014|NCT02097641|FG001|Participant Flow|Plasma-Lyte A|"A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.~Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes."
11186015|NCT02097641|OG000|Outcome|Human Mesenchymal Stem Cells (hMSCs)|"A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.~Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes."
11358735|NCT03505372|EG000|Reported Event|Contrast Enhanced Mammography|"The CESM images will be performed according to clinical protocol~Images will be acquired within approximately 2-12 minutes of contrast injection~A total of four images per breast will be acquired with low and high energy~Two radiologists will prospectively review the CESM, and will use a third as tie-breaker~The CESM will be evaluated for the biopsy site and up to two additional findings in either breast~The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement~Contrast enhanced mammography: Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone."
11358736|NCT03500406|BG000|Baseline|Group 1 - Control|"No treatment will be administered and men will not have to delay their IPP procedure~Control: No treatment"
11358737|NCT03500406|BG001|Baseline|Group 2 - PTT 3x Daily x 3 Months|"Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP~RestoreX: Penile traction therapy in the straight position"
11358738|NCT03500406|BG002|Baseline|Total|Total of all reporting groups
11358739|NCT03500406|FG000|Participant Flow|Group 1 - Control|"No treatment will be administered and men will not have to delay their IPP procedure~Control: No treatment"
11358740|NCT03500406|FG001|Participant Flow|Group 2 - PTT 3x Daily x 3 Months|"Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP~RestoreX: Penile traction therapy in the straight position"
11358741|NCT03500406|OG000|Outcome|Group 1 - Control|"No treatment will be administered and men will not have to delay their IPP procedure~Control: No treatment"
11358742|NCT03500406|OG001|Outcome|Group 2 - PTT 3x Daily x 3 Months|"Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP~RestoreX: Penile traction therapy in the straight position"
11358743|NCT03500406|EG000|Reported Event|Group 1 - Control|"No treatment will be administered and men will not have to delay their IPP procedure~Control: No treatment"
11358744|NCT03500406|EG001|Reported Event|Group 2 - PTT 3x Daily x 3 Months|"Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP~RestoreX: Penile traction therapy in the straight position"
11358745|NCT03500341|BG000|Baseline|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor~INVSENSOR00014: Noninvasive pulse oximeter sensor"
11358746|NCT03500341|FG000|Participant Flow|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor~INVSENSOR00014: Noninvasive pulse oximeter sensor"
11358747|NCT03500341|OG000|Outcome|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor~INVSENSOR00014: Noninvasive pulse oximeter sensor"
11358748|NCT03500341|EG000|Reported Event|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor~INVSENSOR00014: Noninvasive pulse oximeter sensor"
11358749|NCT03500159|BG000|Baseline|AQX-1125|"AQX-1125 200 mg~AQX-1125 200 mg: Synthetic SHIP1 activator"
11358750|NCT03500159|BG001|Baseline|Placebo|"Matching placebo~Placebo: Appearance and weight matched tablets without the active product ingredient"
11358751|NCT03500159|BG002|Baseline|Total|Total of all reporting groups
11358752|NCT03500159|FG000|Participant Flow|AQX-1125|"AQX-1125 200 mg~AQX-1125 200 mg: Synthetic SHIP1 activator"
11358753|NCT03500159|FG001|Participant Flow|Placebo|"Matching placebo~Placebo: Appearance and weight matched tablets without the active product ingredient"
11358754|NCT03500159|OG000|Outcome|AQX-1125|"AQX-1125 200 mg~AQX-1125 200 mg: Synthetic SHIP1 activator"
11358755|NCT03500159|OG001|Outcome|Placebo|"Matching placebo~Placebo: Appearance and weight matched tablets without the active product ingredient"
11358756|NCT03500159|EG000|Reported Event|AQX-1125|"AQX-1125 200 mg~AQX-1125 200 mg: Synthetic SHIP1 activator"
11358757|NCT03500159|EG001|Reported Event|Placebo|"Matching placebo~Placebo: Appearance and weight matched tablets without the active product ingredient"
11358758|NCT03490916|BG000|Baseline|Acetazolamide Normal Dose|"One (1) dose of 250mg of Acetazolamide~Acetazolamide: Administration of Acetazolamide"
11358759|NCT03490916|BG001|Baseline|Placebo|"One (1) dose of placebo~Placebo: Administration of Placebo"
11358760|NCT03490916|BG002|Baseline|Total|Total of all reporting groups
11358761|NCT03490916|FG000|Participant Flow|Acetazolamide Normal Dose|"One (1) dose of 250mg of Acetazolamide~Acetazolamide: Administration of Acetazolamide"
11358762|NCT03490916|FG001|Participant Flow|Placebo|"One (1) dose of placebo~Placebo: Administration of Placebo"
11358763|NCT03490916|OG000|Outcome|Acetazolamide Normal Dose|"One (1) dose of 250mg of Acetazolamide~Acetazolamide: Administration of Acetazolamide"
11358764|NCT03490916|OG001|Outcome|Placebo|"One (1) dose of placebo~Placebo: Administration of Placebo"
11358765|NCT03490916|EG000|Reported Event|Acetazolamide Normal Dose|"One (1) dose of 250mg of Acetazolamide~Acetazolamide: Administration of Acetazolamide"
11358766|NCT03490916|EG001|Reported Event|Placebo|"One (1) dose of placebo~Placebo: Administration of Placebo"
11358767|NCT03483051|BG000|Baseline|ARM A Potassium Nitrate Then Potassium Chloride|"Capsules containing 18 mmoles of KNO3 per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Nitrate: Potassium nitrate capsules will consist of potassium nitrate (KNO3-) crystals [610 mg, corresponding to 6.03 mmoles of NO3-] with 190mg of lactose monohydrate, spray dried, NF. The dose for this trial will be 18 mmoles of NO3-per day, given as one capsule (6 mmoles) three times a day."
11358768|NCT03483051|BG001|Baseline|ARM B Potassium Chloride Then Potassium Nitrate|"Capsules containing 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Chloride: Potassium chloride capsules will consist of potassium chloride (KCl), granular, USP (450mg) plus lactose monohydrate, spray dried, NF (300mg). The dose for this trial will be 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day."
11358769|NCT03483051|BG002|Baseline|Total|Total of all reporting groups
11186016|NCT02097641|OG001|Outcome|Plasma-Lyte A (Placebo)|"A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.~Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes."
11186017|NCT02097641|OG000|Outcome|Human Mesenchymal Stem Cells|"A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.~Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes."
11186018|NCT02097641|OG001|Outcome|Plasma-Lyte A|"A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.~Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes."
11186019|NCT02097641|EG000|Reported Event|Human Mesenchymal Stem Cells|"A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.~Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes."
11186020|NCT02097641|EG001|Reported Event|Plasma-Lyte A|"A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.~Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes."
11186021|NCT02097719|BG000|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
11186022|NCT02097719|BG001|Baseline|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
11186023|NCT02097719|BG002|Baseline|Total|Total of all reporting groups
11186024|NCT02097719|FG000|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
11186025|NCT02097719|FG001|Participant Flow|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
11186026|NCT02097719|OG000|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
11186027|NCT02097719|OG001|Outcome|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
11186028|NCT02097719|EG000|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
11186029|NCT02097719|EG001|Reported Event|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
11186030|NCT02097732|BG000|Baseline|B: No Induction|"Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
11186031|NCT02097732|BG001|Baseline|A: Induction|"Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
11186032|NCT02097732|BG002|Baseline|Total|Total of all reporting groups
11186033|NCT02097732|FG000|Participant Flow|B: No Induction|"Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
11186034|NCT02097732|FG001|Participant Flow|A: Induction|"Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
11186035|NCT02097732|OG000|Outcome|B: No Induction|"Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
11186036|NCT02097732|OG001|Outcome|A: Induction|"Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
11186037|NCT02097732|OG000|Outcome|B: No Induction|Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses. Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses. Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours.
11237444|NCT02455167|BG000|Baseline|HCV Positive Group|"A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.~Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.~Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.~Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment."
11237445|NCT02455167|FG000|Participant Flow|HCV Positive Group|"A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.~Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.~Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.~Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment."
11237446|NCT02455167|OG000|Outcome|HCV Positive Group|"A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.~Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.~Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.~Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment."
11237447|NCT02455167|EG000|Reported Event|HCV Positive Group|"A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.~Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.~Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.~Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment."
11237448|NCT02455336|BG000|Baseline|Fenofibrate|"Subjects with adverse TG concentrations (i.e., paraplegia: >/=135 mg/dl; tetraplegia >/=115 mg/dl) will be randomized to receive once daily fenofibrate therapy (i.e., 145 mg) for 4 months~Fenofibrate: Fenofibrate is a peroxisome proliferator-activated receptor alpha agonist that is demonstrated to reduce triglyceride concentrations in the blood."
11237449|NCT02455336|BG001|Baseline|No Intervention|"Subjects with adverse TG concentrations (i.e., paraplegia: >/=135 mg/dl; tetraplegia >/=115 mg/dl) will be randomized to receive no therapy for 4 months~No intervention: A cohort of participants will be randomized to receive no study drug, but will engage in study encounters."
11237450|NCT02455336|BG002|Baseline|Total|Total of all reporting groups
11237451|NCT02455336|FG000|Participant Flow|Fenofibrate|"Subjects with adverse TG concentrations (i.e., paraplegia: >/=135 mg/dl; tetraplegia >/=115 mg/dl) will be randomized to receive once daily fenofibrate therapy (i.e., 145 mg) for 4 months~Fenofibrate: Fenofibrate is a peroxisome proliferator-activated receptor alpha agonist that is demonstrated to reduce triglyceride concentrations in the blood."
11237452|NCT02455336|FG001|Participant Flow|No Intervention|"Subjects with adverse TG concentrations (i.e., paraplegia: >/=135 mg/dl; tetraplegia >/=115 mg/dl) will be randomized to receive no therapy for 4 months~No intervention: A cohort of participants will be randomized to receive no study drug, but will engage in study encounters."
11237453|NCT02455336|OG000|Outcome|Fenofibrate|"Subjects with adverse TG concentrations (i.e., paraplegia: >/=135 mg/dl; tetraplegia >/=115 mg/dl) will be randomized to receive once daily fenofibrate therapy (i.e., 145 mg) for 4 months~Fenofibrate: Fenofibrate is a peroxisome proliferator-activated receptor alpha agonist that is demonstrated to reduce triglyceride concentrations in the blood."
11237454|NCT02455336|OG001|Outcome|No Intervention|"Subjects with adverse TG concentrations (i.e., paraplegia: >/=135 mg/dl; tetraplegia >/=115 mg/dl) will be randomized to receive no therapy for 4 months~No intervention: A cohort of participants will be randomized to receive no study drug, but will engage in study encounters."
11237455|NCT02455336|EG000|Reported Event|Fenofibrate|"Twenty subjects with adverse TG concentrations (i.e., paraplegia: >/=135 mg/dl; tetraplegia >/=115 mg/dl) will be randomized to receive once daily fenofibrate therapy (i.e., 145 mg) for 4 months~Fenofibrate: Fenofibrate is a peroxisome proliferator-activated receptor alpha agonist that is demonstrated to reduce triglyceride concentrations in the blood."
11237456|NCT02455336|EG001|Reported Event|No Intervention|"Ten subjects with adverse TG concentrations (i.e., paraplegia: >/=135 mg/dl; tetraplegia >/=115 mg/dl) will be randomized to receive no therapy for 4 months~No intervention: A cohort of participants will be randomized to receive no study drug, but will engage in study encounters."
11237457|NCT02455388|BG000|Baseline|Controlled Feeding Study|"Participants will be randomly assigned to consume either a high (25% total energy) or low (5% total energy) added sugar diet for the first 7 consecutive day period. After a 4-week washout period, participants will then consume the other diet for another period of 7 consecutive days.~High added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.~Low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning."
11237458|NCT02455388|BG001|Baseline|Cross-sectional Study|Participants will complete 4 in-person 24-hr dietary recalls within 3 weeks and 2 fingerstick blood samples at Visit 1 and 3.
11237459|NCT02455388|BG002|Baseline|Total|Total of all reporting groups
11237460|NCT02455388|FG000|Participant Flow|Low, Then High Added Sugar Diet|"Participants will consume a low added sugar (5% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will consume a high added sugar (25% total energy) diet for 7 consecutive days.~Low and high added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) or high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning."
11341571|NCT03684265|FG000|Participant Flow|Movalis® Capsules (T), Then Movalis® Tablets (R)|"Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 hours (h) in Period 1, followed with single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 2.~The washout period between two drug administrations was of 7 days."
11341572|NCT03684265|FG001|Participant Flow|Movalis® Tablets (R), Then Movalis® Capsules (T)|"Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 1, followed with single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h in Period 2.~The washout period between two drug administrations was of 7 days."
11341573|NCT03684265|OG000|Outcome|Movalis® Capsules (T)|Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h.
11341574|NCT03684265|OG001|Outcome|Movalis® Tablets (R)|Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h.
11341575|NCT03684265|EG000|Reported Event|Movalis® Capsules (T)|Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h.
11341576|NCT03684265|EG001|Reported Event|Movalis® Tablets (R)|Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h.
11341577|NCT03684642|BG000|Baseline|Efpeglenatide 4 mg|Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.
11341578|NCT03684642|BG001|Baseline|Efpeglenatide 6 mg|Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.
11341579|NCT03684642|BG002|Baseline|Dulaglutide 1.5 mg|Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
11341580|NCT03684642|BG003|Baseline|Total|Total of all reporting groups
11341581|NCT03684642|FG000|Participant Flow|Efpeglenatide 4 mg|Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.
11341582|NCT03684642|FG001|Participant Flow|Efpeglenatide 6 mg|Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.
11341583|NCT03684642|FG002|Participant Flow|Dulaglutide 1.5 mg|Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
11341584|NCT03684642|OG000|Outcome|Efpeglenatide 4 mg|Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.
11341585|NCT03684642|OG001|Outcome|Efpeglenatide 6 mg|Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.
11341586|NCT03684642|OG002|Outcome|Dulaglutide 1.5 mg|Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
11341587|NCT03684642|EG000|Reported Event|Efpeglenatide 4 mg|Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.
11341588|NCT03684642|EG001|Reported Event|Efpeglenatide 6 mg|Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.
11341589|NCT03684642|EG002|Reported Event|Dulaglutide 1.5 mg|Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
11341590|NCT03684928|BG000|Baseline|Overall Study|Total Participants
11341591|NCT03684928|FG000|Participant Flow|Comfilcon A (Test) Then Senofilcon A (Control)|"Participants were randomized to wear comfilcon A contact lenses first then or senofilcon C contact lenses bilaterally for one month during the cross-over study.~Comfilcon A (test): Daily wear contact lenses~Senofilcon C: Daily wear contact lenses"
11341592|NCT03684928|FG001|Participant Flow|Senofilcon C (Control) Then Comfilcon A (Test)|"Participants were randomized to wear Senofilcon C control contact lenses first then Comfilcon A contact lenses bilaterally for one month during the cross-over study.~Comfilcon A (test): Daily wear contact lenses~Senofilcon C: Daily wear contact lenses"
11341593|NCT03684928|OG000|Outcome|Comfilcon A (Test)|"Participants were randomized to wear comfilcon A contact lenses bilaterally for one month during the cross-over study.~Comfilcon A (test): Daily wear contact lenses"
11341594|NCT03684928|OG001|Outcome|Senofilcon C (Control)|"Participants were randomized to wear Senofilcon C control contact lenses bilaterally for one month during the cross-over study.~Senofilcon C: Daily wear contact lenses"
11341595|NCT03684928|EG000|Reported Event|Comfilcon A (Test)|"Participants were randomized to wear comfilcon A contact lenses bilaterally for one month during the cross-over study.~Comfilcon A (test): Daily wear contact lenses"
11341596|NCT03684928|EG001|Reported Event|Senofilcon C (Control)|"Participants were randomized to wear Senofilcon C control contact lenses bilaterally for one month during the cross-over study.~Senofilcon C: Daily wear contact lenses"
11341597|NCT03685344|BG000|Baseline|Dose Escalation: Loncastuximab Tesirine 90 μg/kg|Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11186038|NCT02097732|OG001|Outcome|A: Induction|Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses. Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses. Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours.
11186039|NCT02097732|EG000|Reported Event|Ipilimumab and SRS|"(Induction) Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~OR~(No Induction) Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
11186040|NCT02097745|BG000|Baseline|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
11186041|NCT02097745|FG000|Participant Flow|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
11186042|NCT02097745|OG000|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
11186043|NCT02097745|OG000|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
11186044|NCT02097745|OG001|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
11186045|NCT02097745|EG000|Reported Event|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
11186046|NCT02097745|EG001|Reported Event|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
11186047|NCT02097823|BG000|Baseline|Aprepitant First, Olanzapine Second|"Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
11186048|NCT02097823|BG001|Baseline|Olanzapine First, Aprepitant Second|"Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
11186049|NCT02097823|BG002|Baseline|Total|Total of all reporting groups
11186050|NCT02097823|FG000|Participant Flow|Aprepitant First, Olanzapine Second|"Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
11186051|NCT02097823|FG001|Participant Flow|Olanzapine First, Aprepitant Second|"Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
11186052|NCT02097823|OG000|Outcome|All Participants|Both intervention arms included
11186053|NCT02097823|OG000|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
11186054|NCT02097823|OG001|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
11186055|NCT02097823|EG000|Reported Event|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
11186056|NCT02097823|EG001|Reported Event|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
11186057|NCT02097849|BG000|Baseline|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
11186058|NCT02097849|BG001|Baseline|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
11186059|NCT02097849|BG002|Baseline|Total|Total of all reporting groups
11186060|NCT02097849|FG000|Participant Flow|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
11186061|NCT02097849|FG001|Participant Flow|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
11186062|NCT02097849|OG000|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
11186063|NCT02097849|OG001|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
11186064|NCT02097849|EG000|Reported Event|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
11186065|NCT02097849|EG001|Reported Event|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
11186066|NCT02097992|BG000|Baseline|SD Placebo and MD Roflumilast Then MD Placebo|Participants will receive placebo (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily.
11186067|NCT02097992|BG001|Baseline|SD Placebo and MD Placebo Then MD Roflumilast|Participants will receive placebo (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
11186068|NCT02097992|BG002|Baseline|SD Roflumilast and MD Placebo Then MD Roflumilast.|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
11186069|NCT02097992|BG003|Baseline|SD Roflumilast and MD Roflumilast Then MD Placebo|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily
11186070|NCT02097992|BG004|Baseline|Total|Total of all reporting groups
11186071|NCT02097992|FG000|Participant Flow|SD Placebo and MD Roflumilast Then MD Placebo|Participants will receive placebo (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily.
11186072|NCT02097992|FG001|Participant Flow|SD Placebo and MD Placebo Then MD Roflumilast|Participants will receive placebo (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
11186073|NCT02097992|FG002|Participant Flow|SD Roflumilast and MD Placebo Then MD Roflumilast.|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
11186074|NCT02097992|FG003|Participant Flow|SD Roflumilast and MD Roflumilast Then MD Placebo|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily
11186075|NCT02097992|OG000|Outcome|Long Term Multidose Roflumilast or Placebo|Treatment with 500ug roflumilast or placebo for 4 weeks
11186076|NCT02097992|OG001|Outcome|Acute Roflumilast or Placebo|Treatment with a single dose of 500ug roflumilast or placebo
11186077|NCT02097992|EG000|Reported Event|Single Dose Roflumilast|Participants received a single dose of 500Ug of Roflumilast for one day.
11186078|NCT02097992|EG001|Reported Event|Single Dose Placebo|Participants received a single dose Placebo for one day.
11186079|NCT02097992|EG002|Reported Event|Multi-dose Roflumiast|Participants received a daily dose of 500Ug of Roflumilast for four weeks.
11186080|NCT02097992|EG003|Reported Event|Multi-dose Placebo|Participants received a daily Placebo dose for four weeks
11186081|NCT02098109|BG000|Baseline|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
11186082|NCT02098109|BG001|Baseline|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
11186083|NCT02098109|BG002|Baseline|Total|Total of all reporting groups
11237461|NCT02455388|FG001|Participant Flow|High, Then Low Added Sugar Diet|"Participants will consume high added sugar (25% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will consume a low added sugar (5% total energy) diet for 7 consecutive days.~High and low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) or low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning."
11237462|NCT02455388|FG002|Participant Flow|Dietary Recall and Fingerstick|Participants will complete 4 in-person 24-hr dietary recalls and 2 fingerstick blood samples at visits 1 and 3 within 3 weeks.
11237463|NCT02455388|OG000|Outcome|Cross-sectional Study|Participants will complete 4 in-person 24-hr dietary recalls within 3 weeks and 2 fingerstick blood samples at Visit 1 and 3.
11237464|NCT02455388|OG000|Outcome|Low Added Sugar Diet|"Participants will consume a low added sugar (5% total energy) diet for 7 consecutive days.~Low and high added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) or high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning."
11237465|NCT02455388|OG001|Outcome|High Added Sugar Diet|"Participants will consume high added sugar (25% total energy) diet for 7 consecutive days.~High and low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) or low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning."
11237466|NCT02455388|EG000|Reported Event|Low, Then High Added Sugar Diet|"Participants will consume a low added sugar (5% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will consume a high added sugar (25% total energy) diet for 7 consecutive days.~Low and high added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) or high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning."
11237467|NCT02455388|EG001|Reported Event|High, Then Low Added Sugar Diet|"Participants will consume high added sugar (25% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will consume a low added sugar (5% total energy) diet for 7 consecutive days.~High and low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) or low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning."
11237468|NCT02455388|EG002|Reported Event|Cross-sectional Study|Participants will complete 4 in-person 24-hr dietary recalls and 2 fingerstick blood samples at Visit 1 and 3 within 3 weeks.
11237469|NCT02455453|BG000|Baseline|Diagnostic FFNP-PET/CT Scan|"(2) 18F-FFNP-PET/CT scans~First one prior to estradiol challenge test~Second one immediately following one day of estradiol challenge test~(1) FDG-PET/CT scan at screening~The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study."
11237470|NCT02455453|FG000|Participant Flow|Diagnostic FFNP-PET/CT Scan|"(2) 18F-FFNP-PET/CT scans~First one prior to estradiol challenge test~Second one immediately following one day of estradiol challenge test~(1) FDG-PET/CT scan at screening~The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study."
11237471|NCT02455453|OG000|Outcome|Diagnostic FFNP-PET/CT Scan|"(2) 18F-FFNP-PET/CT scans~First one prior to estradiol challenge test~Second one immediately following one day of estradiol challenge test~(1) FDG-PET/CT scan at screening~The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study."
11237472|NCT02455453|EG000|Reported Event|Diagnostic FFNP-PET/CT Scan|"(2) 18F-FFNP-PET/CT scans~First one prior to estradiol challenge test~Second one immediately following one day of estradiol challenge test~(1) FDG-PET/CT scan at screening~The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study."
11237473|NCT02455518|BG000|Baseline|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
11237474|NCT02455518|BG001|Baseline|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
11237475|NCT02455518|BG002|Baseline|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
11237476|NCT02455518|BG003|Baseline|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
11237477|NCT02455518|BG004|Baseline|Total|Total of all reporting groups
11237478|NCT02455518|FG000|Participant Flow|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
11237479|NCT02455518|FG001|Participant Flow|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
11237480|NCT02455518|FG002|Participant Flow|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
11237481|NCT02455518|FG003|Participant Flow|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
11237482|NCT02455518|OG000|Outcome|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
11237483|NCT02455518|OG001|Outcome|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
11237484|NCT02455518|OG002|Outcome|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
11237485|NCT02455518|OG003|Outcome|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
11237486|NCT02455518|EG000|Reported Event|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
11237487|NCT02455518|EG001|Reported Event|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
11237488|NCT02455518|EG002|Reported Event|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
11237489|NCT02455518|EG003|Reported Event|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
11237490|NCT02456103|BG000|Baseline|Ataluren|Participants were administered ataluren orally at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for up to 96 weeks.
11237491|NCT02456103|FG000|Participant Flow|Ataluren|Participants were administered ataluren orally at a dose of 10 milligrams/grams (mg/kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for up to 96 weeks.
11237492|NCT02456103|OG000|Outcome|Ataluren|Participants were administered ataluren orally at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for up to 96 weeks.
11237493|NCT02456103|EG000|Reported Event|Ataluren|Participants were administered ataluren orally at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for up to 96 weeks.
11237494|NCT02456636|BG000|Baseline|Fee-for-Service (In Clinic Individual Counseling)|"Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.~Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office."
11237495|NCT02456636|BG001|Baseline|Patient Centered Medical Home (In Clinic Group Counseling)|"Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers.~Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional."
11237496|NCT02456636|BG002|Baseline|Disease Management (Phone Group Counseling)|"Participants will take part in group weight-management counseling by telephone.~Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling"
11237497|NCT02456636|BG003|Baseline|Total|Total of all reporting groups
11237498|NCT02456636|FG000|Participant Flow|Fee-for-Service (In Clinic Individual Counseling)|"Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.~Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office."
11237499|NCT02456636|FG001|Participant Flow|Patient Centered Medical Home (In Clinic Group Counseling)|"Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers.~Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional."
11237500|NCT02456636|FG002|Participant Flow|Disease Management (Phone Group Counseling)|"Participants will take part in group weight-management counseling by telephone.~Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling"
11237501|NCT02456636|OG000|Outcome|Fee-for-Service (In Clinic Individual Counseling)|"Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.~Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office."
11237502|NCT02456636|OG001|Outcome|Patient Centered Medical Home (In Clinic Group Counseling)|"Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers.~Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional."
11237503|NCT02456636|OG002|Outcome|Disease Management (Phone Group Counseling)|"Participants will take part in group weight-management counseling by telephone.~Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling"
11237504|NCT02456636|EG000|Reported Event|Fee-for-Service (FFS; In Clinic Individual Counseling)|"Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.~Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office."
11237505|NCT02456636|EG001|Reported Event|Patient Centered Medical Home(PCMH;In Clinic Group Counseling)|"Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers.~Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional."
11237506|NCT02456636|EG002|Reported Event|Disease Management (DM; Phone Group Counseling)|"Participants will take part in group weight-management counseling by telephone.~Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling"
11237507|NCT02456662|BG000|Baseline|Placebo|"160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline~Placebo: placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline"
11237508|NCT02456662|BG001|Baseline|Ondansetron|"160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline~Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline"
11237509|NCT02456662|BG002|Baseline|Total|Total of all reporting groups
11237510|NCT02456662|FG000|Participant Flow|Placebo|"160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline~Placebo: placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline"
11237511|NCT02456662|FG001|Participant Flow|Ondansetron|"160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline~Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline"
11237512|NCT02456662|OG000|Outcome|Placebo|"160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline~Placebo: placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline"
11237513|NCT02456662|OG001|Outcome|Ondansetron|"160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline~Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline"
11186084|NCT02098109|FG000|Participant Flow|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
11186085|NCT02098109|FG001|Participant Flow|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
11186086|NCT02098109|OG000|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
11186087|NCT02098109|OG001|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
11186088|NCT02098109|EG000|Reported Event|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
11186089|NCT02098109|EG001|Reported Event|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
11186090|NCT02098304|BG000|Baseline|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging Device~Calcivis Caries Activity Imaging System: Unrestored sound molars and unsound molars imaged with the Calcivis Caries Activity Imaging System"
11186091|NCT02098304|FG000|Participant Flow|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
11186092|NCT02098304|OG000|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
11186093|NCT02098304|OG000|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
11186094|NCT02098304|OG000|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Teeth imaged with the Calcivis Caries Activity Imaging System"
11186095|NCT02098304|EG000|Reported Event|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
11186096|NCT02098369|BG000|Baseline|Usual Care|"Written education material (basic)~Written education material (basic): Education material on COPD distributed to all participants."
11186097|NCT02098369|BG001|Baseline|Proactive|"Written education material (basic) Additional education material PELICAN-Proactive [In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)]~Written education material (basic): Education material on COPD distributed to all participants.~Additional education material: Additional education material sent to participants in the proactive and reactive arms.~PELICAN-Proactive: In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy."
11186098|NCT02098369|BG002|Baseline|Reactive|"Written education material (basic) Additional education material PELICAN-Reactive [In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)]~Written education material (basic): Education material on COPD distributed to all participants.~Additional education material: Additional education material sent to participants in the proactive and reactive arms.~PELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free."
11186099|NCT02098369|BG003|Baseline|Total|Total of all reporting groups
11186100|NCT02098369|FG000|Participant Flow|Usual Care|"Written education material (basic)~Written education material (basic): Education material on COPD distributed to all participants."
11186101|NCT02098369|FG001|Participant Flow|Proactive|"Written education material (basic) Additional education material PELICAN-Proactive [In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)]~Written education material (basic): Education material on COPD distributed to all participants.~Additional education material: Additional education material sent to participants in the proactive and reactive arms.~PELICAN-Proactive: In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy."
11237514|NCT02456662|EG000|Reported Event|Placebo|"160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline~Placebo: placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline"
11237515|NCT02456662|EG001|Reported Event|Ondansetron|"160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline~Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline"
11237516|NCT02456727|BG000|Baseline|Group Acupuncture|Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.
11237517|NCT02456727|BG001|Baseline|Individual Acupuncture|Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.
11237518|NCT02456727|BG002|Baseline|Total|Total of all reporting groups
11237519|NCT02456727|FG000|Participant Flow|Group Acupuncture|Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.
11237520|NCT02456727|FG001|Participant Flow|Individual Acupuncture|Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.
11237521|NCT02456727|OG000|Outcome|Group Acupuncture ITT|All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.
11237522|NCT02456727|OG001|Outcome|Individual Acupuncture ITT|All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.
11237523|NCT02456727|OG000|Outcome|Group Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended >=8 sessions.
11237524|NCT02456727|OG001|Outcome|Individual Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended >=8 sessions.
11237525|NCT02456727|OG000|Outcome|Group Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended >= 8 sessions.
11237526|NCT02456727|OG001|Outcome|Individual Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended >= 8 sessions.
11237527|NCT02456727|OG001|Outcome|Individual Acupuncture ITT|All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended >=8 sessions.
11237528|NCT02456727|OG000|Outcome|Group Acupuncture ITT|All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and had an active prescription for an opioid medication.
11237529|NCT02456727|OG001|Outcome|Individual Acupuncture ITT|All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and had an active prescription for an opioid medication.
11237530|NCT02456727|OG000|Outcome|Group Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks, attended >=8 sessions and had an active prescription for an opioid medication.
11237531|NCT02456727|OG001|Outcome|Individual Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks, attended >=8 sessions and had an active prescription for an opioid medication.
11237532|NCT02456727|OG000|Outcome|Group Acupuncture ITT|Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive week and had an active prescription for an opioid medication in EMR.
11237533|NCT02456727|OG001|Outcome|Individual Acupuncture ITT|Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive week and had an active prescription for an opioid medication in EMR.
11237534|NCT02456727|OG000|Outcome|Group Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks, attended >=8 sessions and had an active prescription for an opioid medication in EMR (3 months pre- and 3 months post-treatment).
11237535|NCT02456727|OG001|Outcome|Individual Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks, attended >=8 sessions and had an active prescription for an opioid medication in EMR around treatment (3 months pre- and 3 months post-treatment).
11237536|NCT02456727|OG000|Outcome|Group Acupuncture ITT|Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and had an active prescription for an opioid medication in EMR.
11237537|NCT02456727|OG001|Outcome|Individual Acupuncture ITT|Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and had an active prescription for an opioid medication in EMR.
11237538|NCT02456727|OG001|Outcome|Individual Acupuncture PP|All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks, attended >=8 sessions and had an active prescription for an opioid medication in EMR (3 months pre- and 3 months post-treatment).
11237539|NCT02456727|EG000|Reported Event|Group Acupuncture|Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.
11237540|NCT02456727|EG001|Reported Event|Individual Acupuncture|Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.
11237541|NCT02456896|BG000|Baseline|Healthy Control|Twenty five (25) age and sex matched healthy individuals served as the control group.
11237542|NCT02456896|BG001|Baseline|Oxcarbazepine|"Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks.~Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks)."
11237543|NCT02456896|BG002|Baseline|Total|Total of all reporting groups
11237544|NCT02456896|FG000|Participant Flow|Healthy Control|Twenty five (25) age and sex matched healthy individuals served as the control group.
11237545|NCT02456896|FG001|Participant Flow|Oxcarbazepine|"Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks.~Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks)."
10961896|NCT00863356|FG000|Participant Flow|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
10961897|NCT00863356|OG000|Outcome|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
10961898|NCT00863356|EG000|Reported Event|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
11186102|NCT02098369|FG002|Participant Flow|Reactive|"Written education material (basic) Additional education material PELICAN-Reactive [In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)]~Written education material (basic): Education material on COPD distributed to all participants.~Additional education material: Additional education material sent to participants in the proactive and reactive arms.~PELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free."
11186103|NCT02098369|OG000|Outcome|Usual Care|"Written education material (basic)~Written education material (basic): Education material on COPD distributed to all participants."
11186104|NCT02098369|OG001|Outcome|Proactive|"Written education material (basic) Additional education material PELICAN-Proactive [In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)]~Written education material (basic): Education material on COPD distributed to all participants.~Additional education material: Additional education material sent to participants in the proactive and reactive arms.~PELICAN-Proactive: In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy."
11186105|NCT02098369|OG002|Outcome|Reactive|"Written education material (basic) Additional education material PELICAN-Reactive [In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)]~Written education material (basic): Education material on COPD distributed to all participants.~Additional education material: Additional education material sent to participants in the proactive and reactive arms.~PELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free."
11186106|NCT02098369|EG000|Reported Event|Usual Care|"Written education material (basic)~Written education material (basic): Education material on COPD distributed to all participants."
11186107|NCT02098369|EG001|Reported Event|Proactive|"Written education material (basic) Additional education material PELICAN-Proactive [In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)]~Written education material (basic): Education material on COPD distributed to all participants.~Additional education material: Additional education material sent to participants in the proactive and reactive arms.~PELICAN-Proactive: In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy."
11186108|NCT02098369|EG002|Reported Event|Reactive|"Written education material (basic) Additional education material PELICAN-Reactive [In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)]~Written education material (basic): Education material on COPD distributed to all participants.~Additional education material: Additional education material sent to participants in the proactive and reactive arms.~PELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free."
11186109|NCT02098395|BG000|Baseline|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
11186110|NCT02098395|BG001|Baseline|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
11237546|NCT02456896|OG000|Outcome|Healthy Control|Twenty five (25) age and sex matched healthy individuals served as the control group.
11237547|NCT02456896|OG001|Outcome|Oxcarbazepine|"Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks.~Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks)."
11237548|NCT02456896|EG000|Reported Event|Healthy Control|Twenty five (25) age and sex matched healthy individuals served as the control group.
11237549|NCT02456896|EG001|Reported Event|Oxcarbazepine|"Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks.~Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks)."
11237550|NCT02456909|BG000|Baseline|Cues|"The PCA pump will be programmed to provide a cue to the end of the lockout period.~Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump~Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups"
11237551|NCT02456909|BG001|Baseline|No Cues|"The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).~Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.~Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups"
11237552|NCT02456909|BG002|Baseline|Total|Total of all reporting groups
11237553|NCT02456909|FG000|Participant Flow|Cues|"The PCA pump will be programmed to provide a cue to the end of the lockout period.~Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump~Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups"
11237554|NCT02456909|FG001|Participant Flow|No Cues|"The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).~Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.~Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups"
11237555|NCT02456909|OG000|Outcome|Cues|"The PCA pump will be programmed to provide a cue to the end of the lockout period.~Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump~Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups"
11237556|NCT02456909|OG001|Outcome|No Cues|"The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).~Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.~Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups"
11237557|NCT02456909|EG000|Reported Event|Cues|"The PCA pump will be programmed to provide a cue to the end of the lockout period.~Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump~Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups"
11237558|NCT02456909|EG001|Reported Event|No Cues|"The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).~Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.~Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups"
11237559|NCT02457065|BG000|Baseline|Receive Plaque|"Treatment~After the patients enrolled in the study and completed the initial survey, the investigators gave the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors."
11237560|NCT02457065|BG001|Baseline|Do Not Receive Plaque|"Control~After the patients enrolled in the study and completed the initial survey, the investigators did not give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors or any other intervention."
11237561|NCT02457065|BG002|Baseline|Total|Total of all reporting groups
11237562|NCT02457065|FG000|Participant Flow|Receive Plaque|"Treatment~After the patients enrolled in the study and completed the initial survey, the investigators gave the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors."
11237563|NCT02457065|FG001|Participant Flow|Do Not Receive Plaque|"Control~After the patients enrolled in the study and completed the initial survey, the investigators did not give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors or any other intervention."
11237564|NCT02457065|OG000|Outcome|Receive Plaque|"Treatment~After the patients enrolled in the study and completed the initial survey, the investigators gave the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors."
11237565|NCT02457065|OG001|Outcome|Do Not Receive Plaque|"Control~After the patients enrolled in the study and completed the initial survey, the investigators did not give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors or any other intervention."
11237566|NCT02457065|EG000|Reported Event|Receive Plaque|"Treatment~Sun protection behaviors: The investigators give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin-protective behaviors"
11237567|NCT02457065|EG001|Reported Event|Do Not Receive Plaque|"Control~These patients did not receive any intervention from the investigators."
11237568|NCT02457182|BG000|Baseline|Mindfulness-based Stress Reduction (MBSR)|"Will receive usual care continuing current treatments in addition to MBSR~Mindfulness-based Stress Reduction (MBSR)~Usual medical therapy"
11237569|NCT02457182|BG001|Baseline|Usual Care|"Will receive usual care and continue current treatments~Usual medical therapy"
11237570|NCT02457182|BG002|Baseline|Total|Total of all reporting groups
11237571|NCT02457182|FG000|Participant Flow|Mindfulness-based Stress Reduction (MBSR)|"Received usual care continuing current treatments in addition to MBSR~Mindfulness-based Stress Reduction (MBSR)~Usual medical therapy"
11186111|NCT02098395|BG002|Baseline|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
11186112|NCT02098395|BG003|Baseline|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
11186113|NCT02098395|BG004|Baseline|Total|Total of all reporting groups
11186114|NCT02098395|FG000|Participant Flow|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
11186115|NCT02098395|FG001|Participant Flow|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
11186116|NCT02098395|FG002|Participant Flow|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
11186117|NCT02098395|FG003|Participant Flow|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
11186118|NCT02098395|OG000|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
11186119|NCT02098395|OG001|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
11186120|NCT02098395|OG002|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
11186121|NCT02098395|OG003|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
11186122|NCT02098395|EG000|Reported Event|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
11186123|NCT02098395|EG001|Reported Event|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
11186124|NCT02098395|EG002|Reported Event|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
11186125|NCT02098395|EG003|Reported Event|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
11358770|NCT03483051|FG000|Participant Flow|ARM A Potassium Nitrate Then Potassium Chloride|"Capsules containing 18 mmoles of KNO3 per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Nitrate: Potassium nitrate capsules will consist of potassium nitrate (KNO3-) crystals [610 mg, corresponding to 6.03 mmoles of NO3-] with 190mg of lactose monohydrate, spray dried, NF. The dose for this trial will be 18 mmoles of NO3-per day, given as one capsule (6 mmoles) three times a day."
11186126|NCT02098733|BG000|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
11186127|NCT02098733|FG000|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
11186128|NCT02098733|OG000|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
11186129|NCT02098733|EG000|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
11186130|NCT02098746|BG000|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
11186131|NCT02098746|FG000|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
11186132|NCT02098746|OG000|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
11237572|NCT02457182|FG001|Participant Flow|Usual Care|"Received usual care and continue current treatments~Usual medical therapy"
11237573|NCT02457182|OG000|Outcome|Mindfulness-based Stress Reduction (MBSR)|"Received usual care continuing current treatments in addition to MBSR~Mindfulness-based Stress Reduction (MBSR)~Usual medical therapy"
11237574|NCT02457182|OG001|Outcome|Usual Care|"Received usual care and continue current treatments~Usual medical therapy"
11237575|NCT02457182|EG000|Reported Event|Mindfulness-based Stress Reduction (MBSR)|"Received usual care continuing current treatments in addition to MBSR~Mindfulness-based Stress Reduction (MBSR)~Usual medical therapy"
11186133|NCT02098746|EG000|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
11186134|NCT02098993|BG000|Baseline|Unfractionated Heparin|"Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines.~The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.~Unfractionated heparin"
11186135|NCT02098993|BG001|Baseline|Standard of Care|Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.
11186136|NCT02098993|BG002|Baseline|Total|Total of all reporting groups
11186137|NCT02098993|FG000|Participant Flow|Unfractionated Heparin|"Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines.~The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.~Unfractionated heparin"
11186138|NCT02098993|FG001|Participant Flow|Standard of Care|Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.
11186139|NCT02098993|OG000|Outcome|Unfractionated Heparin|"Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines.~The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.~Unfractionated heparin"
11186140|NCT02098993|OG001|Outcome|Standard of Care|Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.
11186141|NCT02098993|EG000|Reported Event|Unfractionated Heparin|"Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines.~The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.~Unfractionated heparin"
11186142|NCT02098993|EG001|Reported Event|Standard of Care|Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.
11186143|NCT02099006|BG000|Baseline|All Study Participants|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline/ Baclofen: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
11186144|NCT02099006|FG000|Participant Flow|All Study Participants|"Each study subject was sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline 2%/ Baclofen 2%: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
11186145|NCT02099006|OG000|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
11186146|NCT02099006|OG001|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
11186147|NCT02099006|EG000|Reported Event|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
11186148|NCT02099006|EG001|Reported Event|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
11186149|NCT02099084|BG000|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Teduglutide first.
11186150|NCT02099084|FG000|Participant Flow|Teduglutide First, Then Placebo|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days, followed by a 14-day washout period, and placebo administered subcutaneously for 7 days.
11186151|NCT02099084|FG001|Participant Flow|Placebo First, Then Teduglutide|Placebo administered subcutaneously for 7 days, followed by a 14-day washout period, and Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days.
11186152|NCT02099084|OG000|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
11186153|NCT02099084|OG001|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
11186154|NCT02099084|EG000|Reported Event|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
11186155|NCT02099084|EG001|Reported Event|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
11186156|NCT02099110|BG000|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
11186157|NCT02099110|BG001|Baseline|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
11186158|NCT02099110|BG002|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
11186159|NCT02099110|BG003|Baseline|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
11186160|NCT02099110|BG004|Baseline|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
11186161|NCT02099110|BG005|Baseline|Total|Total of all reporting groups
11186162|NCT02099110|FG000|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
11186163|NCT02099110|FG001|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
11186164|NCT02099110|FG002|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
11186165|NCT02099110|FG003|Participant Flow|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
11186166|NCT02099110|FG004|Participant Flow|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
11186167|NCT02099110|OG000|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
11186168|NCT02099110|OG001|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
11186169|NCT02099110|OG002|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
11186170|NCT02099110|OG003|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
11186171|NCT02099110|OG004|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
11186172|NCT02099110|EG000|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
11186173|NCT02099110|EG001|Reported Event|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
11186174|NCT02099110|EG002|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
11186175|NCT02099110|EG003|Reported Event|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
11186176|NCT02099110|EG004|Reported Event|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
11186177|NCT02099266|BG000|Baseline|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
11186178|NCT02099266|FG000|Participant Flow|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
11186179|NCT02099266|OG000|Outcome|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
11186180|NCT02099266|OG000|Outcome|Reduced-Intensity Conditioning|"Reduced-Intensity (also referred to as: Non-myeloablative) transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:~Day -6 : fludarabine 40mg/m2 (milligram per meter squared) intravenously (IV), cyclophosphamide 50mg/kg IV, and mesna 50mg/kg IV Day-5 to -2: fludarabine 40mg/m2 intravenously (IV) Day -1: Total body irradiation (TBI) 200 centrigray (cGy)"
11186181|NCT02099266|OG001|Outcome|Myeloablative Conditioning|"Myeloablative transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:~Day -10, -9, and -8: Fludarabine (25 mg/m2 IV) IV Day -7, -6, -5, and -4: Total body irradiation 165 cGy twice daily Day -3 and -2: Cyclophosphamide (60 mg/kg/day ) and mesna 50mg/kg/day (milligrams per kilogram per day) IV"
11186182|NCT02099266|OG000|Outcome|Reduced-Intensity Conditioning|
11186183|NCT02099266|EG000|Reported Event|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
11237576|NCT02457182|EG001|Reported Event|Usual Care|"Received usual care and continue current treatments~Usual medical therapy"
11237577|NCT02457195|BG000|Baseline|Admnistration of Granisetron|"Preoperative administration of granisetron transdemal patch~granisetron: Application granisetron transdermal patch preoperatively"
11237578|NCT02457195|FG000|Participant Flow|Admnistration of Granisetron|"Preoperative administration of granisetron transdemal patch~granisetron: Application granisetron transdermal patch preoperatively"
11237579|NCT02457195|OG000|Outcome|Admnistration of Granisetron|Outcomes measured in the study patients after application of transdermal granisetron patch throughout the study period
11237580|NCT02457195|EG000|Reported Event|Admnistration of Granisetron|"Preoperative administration of granisetron transdemal patch~granisetron: Application granisetron transdermal patch preoperatively"
11237581|NCT02457247|BG000|Baseline|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
11237582|NCT02457247|BG001|Baseline|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
11237583|NCT02457247|BG002|Baseline|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
11237584|NCT02457247|BG003|Baseline|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
11237585|NCT02457247|BG004|Baseline|Total|Total of all reporting groups
11237586|NCT02457247|FG000|Participant Flow|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
11237587|NCT02457247|FG001|Participant Flow|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
11237588|NCT02457247|FG002|Participant Flow|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
11237589|NCT02457247|FG003|Participant Flow|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
11237590|NCT02457247|OG000|Outcome|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
11237591|NCT02457247|OG001|Outcome|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
11237592|NCT02457247|OG002|Outcome|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
11237593|NCT02457247|OG003|Outcome|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
11237594|NCT02457247|OG004|Outcome|Test Group 1: Total|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2 and Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2.
11237595|NCT02457247|OG005|Outcome|Test Group 2: Total|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, for 14 days in either Period 1 or 2 and Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, for 14 days in either Period 1 or 2.
11237596|NCT02457247|OG000|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
11237597|NCT02457247|OG001|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
11237598|NCT02457247|OG002|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
11237599|NCT02457247|OG003|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
11237600|NCT02457247|EG000|Reported Event|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
11237601|NCT02457247|EG001|Reported Event|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
11237602|NCT02457247|EG002|Reported Event|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
11237603|NCT02457247|EG003|Reported Event|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
11237604|NCT02457260|BG000|Baseline|Healthy Control|"12 healthy adults, age 70 or older to receive 14 Nitrogen (14N) sodium nitrite, 40 mg tid~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11186184|NCT02099461|BG000|Baseline|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186185|NCT02099461|BG001|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186186|NCT02099461|BG002|Baseline|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186187|NCT02099461|BG003|Baseline|Total|Total of all reporting groups
11186188|NCT02099461|FG000|Participant Flow|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186189|NCT02099461|FG001|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186190|NCT02099461|FG002|Participant Flow|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186191|NCT02099461|OG000|Outcome|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186192|NCT02099461|OG001|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186193|NCT02099461|OG002|Outcome|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186194|NCT02099461|EG000|Reported Event|Treatment A No Treatment|Participants in this group received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186195|NCT02099461|EG001|Reported Event|Treatment B 60 MG SC|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186196|NCT02099461|EG002|Reported Event|Treatment C 120 MG SC|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
11186197|NCT02099682|BG000|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
11186198|NCT02099682|FG000|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
11186199|NCT02099682|OG000|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
11186200|NCT02099682|EG000|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
11186201|NCT02099708|BG000|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
11186202|NCT02099708|FG000|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
11186203|NCT02099708|OG000|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
11186204|NCT02099708|EG000|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
11186205|NCT02099721|BG000|Baseline|Group A: Secondary Prevention Patients- Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186206|NCT02099721|BG001|Baseline|Group B: Secondary Prevention Patients - no Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.~These subjects choose not to receive an ICD/CRT-D implant."
11186207|NCT02099721|BG002|Baseline|Group C: 1.5 Prevention Patients - Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186208|NCT02099721|BG003|Baseline|Group D: 1.5 Prevention Patients - no Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects choose not to receive an ICD/CRT-D implant."
11186209|NCT02099721|BG004|Baseline|Group E: Primary, Non-1.5 Patients - Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186210|NCT02099721|BG005|Baseline|Group F: Primary, Non-1.5 Patients - no Device|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.~These subjects choose not to receive an ICD/CRT-D implant."
11186211|NCT02099721|BG006|Baseline|Total|Total of all reporting groups
11358771|NCT03483051|FG001|Participant Flow|ARM B Potassium Chloride Then Potassium Nitrate|"Capsules containing 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Chloride: Potassium chloride capsules will consist of potassium chloride (KCl), granular, USP (450mg) plus lactose monohydrate, spray dried, NF (300mg). The dose for this trial will be 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day."
11358772|NCT03483051|OG000|Outcome|ARM A Potassium Nitrate Then Potassium Chloride|"Capsules containing 18 mmoles of KNO3 per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Nitrate: Potassium nitrate capsules will consist of potassium nitrate (KNO3-) crystals [610 mg, corresponding to 6.03 mmoles of NO3-] with 190mg of lactose monohydrate, spray dried, NF. The dose for this trial will be 18 mmoles of NO3-per day, given as one capsule (6 mmoles) three times a day."
11358773|NCT03483051|OG001|Outcome|ARM B Potassium Chloride Then Potassium Nitrate|"Capsules containing 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Chloride: Potassium chloride capsules will consist of potassium chloride (KCl), granular, USP (450mg) plus lactose monohydrate, spray dried, NF (300mg). The dose for this trial will be 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day."
11358774|NCT03483051|OG000|Outcome|Potassium Nitrate (KNO3)|"Capsules containing 18 mmoles of KNO3 per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Nitrate: Potassium nitrate capsules will consist of potassium nitrate (KNO3-) crystals [610 mg, corresponding to 6.03 mmoles of NO3-] with 190mg of lactose monohydrate, spray dried, NF. The dose for this trial will be 18 mmoles of NO3-per day, given as one capsule (6 mmoles) three times a day."
11358775|NCT03483051|OG001|Outcome|Potassium Chloride|"Capsules containing 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Chloride: Potassium chloride capsules will consist of potassium chloride (KCl), granular, USP (450mg) plus lactose monohydrate, spray dried, NF (300mg). The dose for this trial will be 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day."
11358776|NCT03483051|EG000|Reported Event|ARM A Potassium Nitrate Then Potassium Chloride|"Capsules containing 18 mmoles of KNO3 per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Nitrate: Potassium nitrate capsules will consist of potassium nitrate (KNO3-) crystals [610 mg, corresponding to 6.03 mmoles of NO3-] with 190mg of lactose monohydrate, spray dried, NF. The dose for this trial will be 18 mmoles of NO3-per day, given as one capsule (6 mmoles) three times a day."
11358777|NCT03483051|EG001|Reported Event|ARM B Potassium Chloride Then Potassium Nitrate|"Capsules containing 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day for 4 weeks.~Potassium Chloride: Potassium chloride capsules will consist of potassium chloride (KCl), granular, USP (450mg) plus lactose monohydrate, spray dried, NF (300mg). The dose for this trial will be 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day."
11358778|NCT03477903|BG000|Baseline|TAK-954 0.1 mg|TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
11358779|NCT03477903|FG000|Participant Flow|TAK-954 0.1 mg|TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
11358780|NCT03477903|OG000|Outcome|TAK-954 0.1 mg|TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
11358781|NCT03477903|EG000|Reported Event|TAK-954 0.1 mg|TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
11358782|NCT03469258|BG000|Baseline|Zenpep|"Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously.~Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date~Pancrelipase: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer."
11358783|NCT03469258|FG000|Participant Flow|Zenpep|"Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously.~Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date~Pancrelipase: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer."
11358784|NCT03469258|OG000|Outcome|Zenpep|"Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously.~Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date~Pancrelipase: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer."
11358785|NCT03469258|EG000|Reported Event|Zenpep|"Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously.~Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date~Pancrelipase: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer."
11358786|NCT03466658|BG000|Baseline|All Participants|Enrolled participants served as their own control. The surgical shoulder served as the Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder served as the Control Shoulder.
11358787|NCT03466658|FG000|Participant Flow|All Participants|Enrolled participants served as their own control. The surgical shoulder served as the Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder served as the Control Shoulder.
11358788|NCT03466658|OG000|Outcome|JumpStart Group|"This group will have the JumpStart dressing pre-operatively. Intervention: JumpStart dressing~JumpStart Antimicrobial Wound Dressing: A novel, wireless, low-level microcurrent-generating antimicrobial device (JumpStart) is a sterile single layer dressing consisting of a matrix of alternating silver (Ag) and zinc (Zn) dots that are held in positions on a polyester substrate with biocompatible binder. Dressing is then activated in the presence of a conductive fluid, which may come from wound exudate or exogenous fluids, such as saline. It has been observed, in vitro, to exhibit electricidal effect in the presence of antibiotic and multidrug resistant clinical wound isolates."
11358789|NCT03466658|OG001|Outcome|Control Group|This group will have no intervention pre-operatively. Intervention: none
11358790|NCT03466658|EG000|Reported Event|JumpStart Group|"This group will have the JumpStart dressing pre-operatively. Intervention: JumpStart dressing~JumpStart Antimicrobial Wound Dressing: A novel, wireless, low-level microcurrent-generating antimicrobial device (JumpStart) is a sterile single layer dressing consisting of a matrix of alternating silver (Ag) and zinc (Zn) dots that are held in positions on a polyester substrate with biocompatible binder. Dressing is then activated in the presence of a conductive fluid, which may come from wound exudate or exogenous fluids, such as saline. It has been observed, in vitro, to exhibit electricidal effect in the presence of antibiotic and multidrug resistant clinical wound isolates."
11358791|NCT03466658|EG001|Reported Event|Control Group|This group will have no intervention pre-operatively. Intervention: none
11358792|NCT03465891|BG000|Baseline|Atezolizumab|"All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).~atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year)."
11358793|NCT03465891|BG001|Baseline|Atezolizumab Plus Low-dose, Local Radiotherapy|"All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).~atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).~Low- Dose, Local Radiotherapy: 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab )."
11358794|NCT03465891|BG002|Baseline|Total|Total of all reporting groups
11358795|NCT03465891|FG000|Participant Flow|Atezolizumab|"All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).~atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year)."
11358796|NCT03465891|FG001|Participant Flow|Atezolizumab Plus Low-dose, Local Radiotherapy|"All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).~atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).~Low- Dose, Local Radiotherapy: 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab )."
11358797|NCT03465891|OG000|Outcome|Atezolizumab|"All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).~atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year)."
11358798|NCT03465891|OG001|Outcome|Atezolizumab Plus Low-dose, Local Radiotherapy|"All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).~atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).~Low- Dose, Local Radiotherapy: 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab )."
11358799|NCT03465891|EG000|Reported Event|Atezolizumab|"All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).~atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year)."
11358800|NCT03465891|EG001|Reported Event|Atezolizumab Plus Low-dose, Local Radiotherapy|"All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).~atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).~Low- Dose, Local Radiotherapy: 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab )."
11358801|NCT03465735|BG000|Baseline|Standard of Care|"Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present.~Standard of Care: Anticoagulant therapy will be decided by physician and patient."
11186212|NCT02099721|FG000|Participant Flow|Group A: Secondary Prevention Patients- Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186213|NCT02099721|FG001|Participant Flow|Group B: Secondary Prevention Patients - no Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.~These subjects chose not to receive an ICD/CRT-D implant."
11186214|NCT02099721|FG002|Participant Flow|Group C: 1.5 Prevention Patients - Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186215|NCT02099721|FG003|Participant Flow|Group D: 1.5 Prevention Patients - no Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects chose not to receive an ICD/CRT-D implant."
11186216|NCT02099721|FG004|Participant Flow|Group E: Primary, Non-1.5 Patients - Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186217|NCT02099721|FG005|Participant Flow|Group F: Primary, Non-1.5 Patients - no Device|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.~These subjects chose not to receive an ICD/CRT-D implant."
11186218|NCT02099721|OG000|Outcome|Group A: Secondary Prevention Patients - Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186219|NCT02099721|OG001|Outcome|Group C: 1.5 Prevention Patients - Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186220|NCT02099721|OG000|Outcome|Group C: 1.5 Prevention Patients - Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects receive an ICD/CRT-D implant.~ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis."
11186221|NCT02099721|OG001|Outcome|Group D: 1.5 Prevention Patients - no Device Implant|"Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects choose not to receive an ICD/CRT-D implant."
11186222|NCT02099721|EG000|Reported Event|Group A: Secondary Prevention Patients - Device Implanted|"Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.~These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming.~The programming is not investigational.~Consistent programming is desirable in order to compare groups during statistical analysis."
11186223|NCT02099721|EG001|Reported Event|Group B: Secondary Prevention Patients - No Device Implanted|"Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.~These subjects did not receive an ICD/CRT-D implant."
11237605|NCT02457260|BG001|Baseline|Heart Failure With Preserved Ejection Fraction (HFpEF)|"7 adults with heart failure and preserved ejection fraction age 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237606|NCT02457260|BG002|Baseline|Heart Failure With Reduced Ejection Fraction(HFrEF)|"2 adults with heart failure and reduced ejection fraction aged 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237607|NCT02457260|BG003|Baseline|Total|Total of all reporting groups
11237608|NCT02457260|FG000|Participant Flow|Healthy Control|"12 healthy adults, age 70 or older to receive 14 Nitrogen (14N) sodium nitrite, 40 mg tid~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237609|NCT02457260|FG001|Participant Flow|HFpEF|"7 adults with heart failure and preserved ejection fraction age 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237610|NCT02457260|FG002|Participant Flow|HFrEF|"2 adults with heart failure and reduced ejection fraction aged 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237611|NCT02457260|OG000|Outcome|Healthy Control|"10 healthy adults, age 70 or older to receive 14 Nitrogen (14N) sodium nitrite, 40 mg tid~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237612|NCT02457260|OG001|Outcome|HFpEF|"4 adults with heart failure and preserved ejection fraction age 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237613|NCT02457260|OG002|Outcome|HFrEF|"1 adults with heart failure and reduced ejection fraction aged 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237614|NCT02457260|OG000|Outcome|Healthy Control|"0 healthy adults, age 70 or older to receive 14 Nitrogen (14N) sodium nitrite, 40 mg tid~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237615|NCT02457260|EG000|Reported Event|Healthy Control|"12 healthy adults, age 70 or older to receive 14 Nitrogen (14N) sodium nitrite, 40 mg tid~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237616|NCT02457260|EG001|Reported Event|HFpEF|"7 adults with heart failure and preserved ejection fraction age 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237617|NCT02457260|EG002|Reported Event|HFrEF|"2 adults with heart failure and reduced ejection fraction aged 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety~14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks"
11237618|NCT02457325|BG000|Baseline|Surgery With 2%Articaine First, Then Surgery With 4% Articaine|First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
11237619|NCT02457325|BG001|Baseline|Surgery With 4%Articaine First, Then Surgery With 2%Articaine|First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)
11237620|NCT02457325|BG002|Baseline|Total|Total of all reporting groups
11237621|NCT02457325|FG000|Participant Flow|Surgery With 2% Articaine First, Then 4% Articaine|First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
11237622|NCT02457325|FG001|Participant Flow|Surgery With 4%Articaine First, Then 2% Articaine|First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)
11237623|NCT02457325|OG000|Outcome|Surgery With 2%Articaine|Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)
11237624|NCT02457325|OG001|Outcome|Surgery With 4%Articaine|Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
11237625|NCT02457325|EG000|Reported Event|Surgery With 2%Articaine|Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)
11237626|NCT02457325|EG001|Reported Event|Surgery With 4%Articaine|Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
11237627|NCT02457403|BG000|Baseline|ROTEM|Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets & 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.
11237628|NCT02457403|BG001|Baseline|Conventional|Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at < 100 mg/dL, 1 unit of cryoprecipitate was also transfused.
11237629|NCT02457403|BG002|Baseline|Total|Total of all reporting groups
11237630|NCT02457403|FG000|Participant Flow|ROTEM|Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.
11237631|NCT02457403|FG001|Participant Flow|Conventional|Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.
11237632|NCT02457403|OG000|Outcome|ROTEM|Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets & 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.
11186224|NCT02099721|EG002|Reported Event|Group C: 1.5 Prevention Patients - Device Implant|"Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming.~The programming is not investigational.~Consistent programming is desirable in order to compare groups during statistical analysis."
11186225|NCT02099721|EG003|Reported Event|Group D: 1.5 Prevention Patients - No Device Implant|"Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects did not receive an ICD/CRT-D implant."
11186226|NCT02099721|EG004|Reported Event|Group E: 1.0 Prevention Patients - Device Implant|"Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have none of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming.~The programming is not investigational.~Consistent programming is desirable in order to compare groups during statistical analysis."
11186227|NCT02099721|EG005|Reported Event|Group F: 1.0 Prevention Patients - No Device Implant|"Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have none of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).~These subjects did not receive an ICD/CRT-D implant."
11186228|NCT02099786|BG000|Baseline|COMP-VA|"Hearing testing at each treatment and at 1 month following treatment.~COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist"
11186229|NCT02099786|BG001|Baseline|Usual Care|"Hearing testing done according to Audiology Clinic protocol~Standard of care: Hearing testing done in the audiology clinic after oncology referral"
11186230|NCT02099786|BG002|Baseline|Total|Total of all reporting groups
11186231|NCT02099786|FG000|Participant Flow|COMP-VA|"Hearing testing at each treatment and at 1 month following treatment.~COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist"
11186232|NCT02099786|FG001|Participant Flow|Usual Care|"Hearing testing done according to Audiology Clinic protocol~Standard of care: Hearing testing done in the audiology clinic after oncology referral"
11186233|NCT02099786|OG000|Outcome|COMP-VA|"Hearing testing at each treatment and at 1 month following treatment.~COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist"
11186234|NCT02099786|OG001|Outcome|Usual Care|"Hearing testing done according to Audiology Clinic protocol~Standard of care: Hearing testing done in the audiology clinic after oncology referral"
11186235|NCT02099786|OG001|Outcome|Usual Care|"Hearing testing done according to Audiology Clinic protocol~Standard of care: Hearing testing done in the audiology clinic after oncology referral or patient self referral"
11186236|NCT02099786|EG000|Reported Event|COMP-VA|"Hearing testing at each treatment and at 1 month following treatment.~COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist"
11186237|NCT02099786|EG001|Reported Event|Usual Care|"Hearing testing done according to Audiology Clinic protocol~Standard of care: Hearing testing done in the audiology clinic after oncology referral"
11186238|NCT02099799|BG000|Baseline|Pedometer and Internet Website|"Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.~Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR).~204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 75 allocated to Pedometer and Internet Website Arm (54 BOS and 21 BIR) 15 Lost to follow-up at 6 months (8 BOS and 7 BIR) 74 included in the analyses"
11186239|NCT02099799|BG001|Baseline|Usual Care|"Verbal instructions and written materials about exercise. Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR).~204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 78 allocated to Pedometer and Internet Website Arm (54 BOS and 24 BIR) 24 Lost to follow-up at 6 months (13 BOS and 11 BIR) 78 included in the analyses"
11186240|NCT02099799|BG002|Baseline|Total|Total of all reporting groups
11186241|NCT02099799|FG000|Participant Flow|Pedometer and Internet Website|Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
11186242|NCT02099799|FG001|Participant Flow|Usual Care|Verbal instructions and written materials about exercise.
11186243|NCT02099799|OG000|Outcome|Pedometer and Internet Website|"Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.~Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR).~204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 75 allocated to Pedometer and Internet Website Arm (54 BOS and 21 BIR) 15 Lost to follow-up at 6 months (8 BOS and 7 BIR) 74 included in the analyses"
11186244|NCT02099799|OG001|Outcome|Usual Care|"Verbal instructions and written materials about exercise. Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR).~204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 78 allocated to Pedometer and Internet Website Arm (54 BOS and 24 BIR) 24 Lost to follow-up at 6 months (13 BOS and 11 BIR) 78 included in the analyses"
11237633|NCT02457403|OG001|Outcome|Conventional|Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at < 100 mg/dL, 1 unit of cryoprecipitate was also transfused.
11237634|NCT02457403|OG000|Outcome|ROTEM|Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.
11237635|NCT02457403|OG001|Outcome|Conventional|Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.
11237636|NCT02457403|EG000|Reported Event|ROTEM|Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.
11237637|NCT02457403|EG001|Reported Event|Conventional|Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.
11237638|NCT02457520|BG000|Baseline|Single Treatment Arm|Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.
11237639|NCT02457520|FG000|Participant Flow|Single Treatment Arm|Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.
11237640|NCT02457520|OG000|Outcome|Single Treatment Arm|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237641|NCT02457520|OG000|Outcome|Single Treatment Arm-Week 16|"Visit 7/Week 16~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237642|NCT02457520|OG001|Outcome|Single Treatment Arm-Week 12|"Visit 6/Week 12~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237643|NCT02457520|OG002|Outcome|Single Treatment Arm-Week 8|"Visit 5/Week 8~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237644|NCT02457520|OG003|Outcome|Single Treatment Arm-Week 4|"Visit 4/Week 4~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237645|NCT02457520|OG000|Outcome|Single Treatment Arm-Self Perception|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237646|NCT02457520|OG001|Outcome|Single Treatment Arm-Role-Emotional|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237647|NCT02457520|OG002|Outcome|Single Treatment Arm-Role-Social|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237648|NCT02457520|OG003|Outcome|Single Treatment Arm-Acne Symptoms|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237649|NCT02457520|OG000|Outcome|Single Treatment Arm-Retreat With Prescription Anti-acne Medic|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237650|NCT02457520|OG001|Outcome|Single Treatment Arm - Retreat With Over-the-counter Anti-acne|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237651|NCT02457520|OG002|Outcome|Single Treatment Arm- Retreat With Prescription or Over-the-co|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237652|NCT02457520|OG000|Outcome|Single Treatment Arm- Total|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237653|NCT02457520|OG001|Outcome|Single Treatment Arm -Non-inflammatory|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237654|NCT02457520|OG002|Outcome|Single Treatment Arm-Inflammatory|"ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237655|NCT02457520|OG000|Outcome|Single Treatment Arm-Inflammatory|"Change from baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237656|NCT02457520|OG001|Outcome|Single Treatment Arm -Non-inflammatory|"Change from baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11186245|NCT02099799|OG000|Outcome|Pedometer and Internet Website|"Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.~Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum."
11186246|NCT02099799|OG001|Outcome|Usual Care|Verbal instructions and written materials about exercise.
11186247|NCT02099799|EG000|Reported Event|Pedometer and Internet Website|"Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.~Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR).~204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 75 allocated to Pedometer and Internet Website Arm (54 BOS and 21 BIR) 15 Lost to follow-up at 6 months (8 BOS and 7 BIR) 74 included in the analyses"
11186248|NCT02099799|EG001|Reported Event|Usual Care|"Verbal instructions and written materials about exercise. Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR).~204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 78 allocated to Pedometer and Internet Website Arm (54 BOS and 24 BIR) 24 Lost to follow-up at 6 months (13 BOS and 11 BIR) 78 included in the analyses"
11186249|NCT02099838|BG000|Baseline|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
11186250|NCT02099838|BG001|Baseline|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
11186251|NCT02099838|BG002|Baseline|Total|Total of all reporting groups
11186252|NCT02099838|FG000|Participant Flow|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
11186253|NCT02099838|FG001|Participant Flow|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
11186254|NCT02099838|OG000|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
11186255|NCT02099838|OG001|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
11186256|NCT02099838|EG000|Reported Event|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
11186257|NCT02099838|EG001|Reported Event|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
11186258|NCT02099864|BG000|Baseline|Treatment (Enzalutamide)|"Patients receive enzalutamide PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo a tumor biopsy of a metastatic site at study entry (prior to initiation of enzalutamide) and after the time of progression. Per the investigator, patients may continue treatment beyond progression.~Enzalutamide: Given PO"
11186259|NCT02099864|FG000|Participant Flow|Treatment (Enzalutamide)|"Patients receive enzalutamide PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo a tumor biopsy of a metastatic site at study entry (prior to initiation of enzalutamide) and after the time of progression. Per the investigator, patients may continue treatment beyond progression.~Enzalutamide: Given PO"
11186260|NCT02099864|OG000|Outcome|Treatment (Enzalutamide)|"Patients receive enzalutamide PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo a tumor biopsy of a metastatic site at study entry (prior to initiation of enzalutamide) and after the time of progression. Per the investigator, patients may continue treatment beyond progression.~Enzalutamide: Given PO"
11186261|NCT02099864|OG000|Outcome|Responders|PSA Responder: A ≥ 50% reduction at 12 weeks after the initiation of therapy vs. baseline. Baseline PSA will be defined as the measurement obtained immediately prior to initiation of Enzalutamide on Day 1 of study.
11186262|NCT02099864|OG001|Outcome|PSA Non-responders|PSA Non-Responder: A less than 50% reduction at 12 weeks after the initiation of therapy vs. baseline. Baseline PSA will be defined as the measurement obtained immediately prior to initiation of Enzalutamide on Day 1 of study.
11186263|NCT02099864|OG001|Outcome|Non-responders|PSA Non-Responder: A less than 50% reduction at 12 weeks after the initiation of therapy vs. baseline. Baseline PSA will be defined as the measurement obtained immediately prior to initiation of Enzalutamide on Day 1 of study.
11186264|NCT02099864|OG001|Outcome|PSA Non-responders|PSA non-responders: A less than 50% reduction at 12 weeks after the initiation of therapy vs. baseline. Baseline PSA will be defined as the measurement obtained immediately prior to initiation of Enzalutamide on Day 1 of study.
11237657|NCT02457520|OG002|Outcome|Single Treatment Arm- Total|"Change from baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11186265|NCT02099864|EG000|Reported Event|Treatment (Enzalutamide)|"Patients receive enzalutamide PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo a tumor biopsy of a metastatic site at study entry (prior to initiation of enzalutamide) and after the time of progression. Per the investigator, patients may continue treatment beyond progression.~Enzalutamide: Given PO"
11186266|NCT02100007|BG000|Baseline|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
11186267|NCT02100007|FG000|Participant Flow|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
11186268|NCT02100007|OG000|Outcome|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
11186269|NCT02100007|OG000|Outcome|ME-344|ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle ...
11186270|NCT02100007|EG000|Reported Event|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
11186271|NCT02100072|BG000|Baseline|Nd:YAG 1440 nm Laser|Nd:YAG 1440 nm laser
11186272|NCT02100072|FG000|Participant Flow|Nd:YAG 1440 nm Laser|"Nd:YAG Laser With 1440nm Wavelength.~Each subject received 1 treatment using this laser over an approximately 3x4 cm area."
11186273|NCT02100072|OG000|Outcome|Nd:YAG 1440 nm Laser|"Nd:YAG Laser With 1440nm Wavelength.~Each subject received 1 treatment using this laser over an approximately 3x4 cm area."
11186274|NCT02100072|EG000|Reported Event|Nd:YAG 1440 nm Laser|Nd:YAG 1440 nm laser
11186275|NCT02100124|BG000|Baseline|Reproductive Life Planning (RLP)|"RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.~Reproductive Life Planning (RLP)~Contraception information"
11186276|NCT02100124|BG001|Baseline|Reproductive Life Planning Plus (RLP+)|"RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.~Reproductive Life Planning (RLP)~Contraceptive Action Planning~Contraception information"
11186277|NCT02100124|BG002|Baseline|Information-only Control|"The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.~Contraception information"
11186278|NCT02100124|BG003|Baseline|Total|Total of all reporting groups
11186279|NCT02100124|FG000|Participant Flow|Reproductive Life Planning (RLP)|"RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.~Reproductive Life Planning (RLP)~Contraception information"
11186280|NCT02100124|FG001|Participant Flow|Reproductive Life Planning Plus (RLP+)|"RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.~Reproductive Life Planning (RLP)~Contraceptive Action Planning~Contraception information"
11186281|NCT02100124|FG002|Participant Flow|Information-only Control|"The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.~Contraception information"
11186282|NCT02100124|OG000|Outcome|Reproductive Life Planning (RLP)|"RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.~Reproductive Life Planning (RLP)~Contraception information"
11186283|NCT02100124|OG001|Outcome|Reproductive Life Planning Plus (RLP+)|"RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.~Reproductive Life Planning (RLP)~Contraceptive Action Planning~Contraception information"
11186284|NCT02100124|OG002|Outcome|Information-only Control|"The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.~Contraception information"
11186285|NCT02100124|EG000|Reported Event|Reproductive Life Planning (RLP)|"RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.~Reproductive Life Planning (RLP)~Contraception information"
11358802|NCT03465735|BG001|Baseline|Vascular Boot Group|"For each vascular boot session, the following data will be recorded:~Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day~Vascular Boot: The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.~Standard of Care: Anticoagulant therapy will be decided by physician and patient."
11358803|NCT03465735|BG002|Baseline|Total|Total of all reporting groups
11358804|NCT03465735|FG000|Participant Flow|Standard of Care|"Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present.~Standard of Care: Anticoagulant therapy will be decided by physician and patient."
11358805|NCT03465735|FG001|Participant Flow|Vascular Boot Group|"For each vascular boot session, the following data will be recorded:~Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day~Vascular Boot: The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.~Standard of Care: Anticoagulant therapy will be decided by physician and patient."
11358806|NCT03465735|OG000|Outcome|Standard of Care|"Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present.~Standard of Care: Anticoagulant therapy will be decided by physician and patient."
11358807|NCT03465735|OG001|Outcome|Vascular Boot Group|"For each vascular boot session, the following data will be recorded:~Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day~Vascular Boot: The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.~Standard of Care: Anticoagulant therapy will be decided by physician and patient."
11358808|NCT03465735|EG000|Reported Event|Standard of Care|"Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present.~Standard of Care: Anticoagulant therapy will be decided by physician and patient."
11358809|NCT03465735|EG001|Reported Event|Vascular Boot Group|"For each vascular boot session, the following data will be recorded:~Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day~Vascular Boot: The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.~Standard of Care: Anticoagulant therapy will be decided by physician and patient."
11358810|NCT03461705|BG000|Baseline|Primary|"All patients who are referred for coronary angiography and require physiological assessment of intermediate lesions will have both RFR and iFR measured during their standard of care procedure. Both the RFR wire (St. Jude Medical (SJM) Aeris Pressure Wire System) and iFR (Volcano Verrata Pressure Wire) wire will be advanced across the lesion with the sensor located at least 3 cm distal from the lesion.~Volcano Verrata Pressure Wire: Steerable guidewire with a pressure transducer mounted 3cm proximal to the tip. The guidewire has a diameter of 0.014.~and is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.~St. Jude Medical (SJM) Aeris Pressure Wire System: The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters."
11358811|NCT03461705|FG000|Participant Flow|Primary|"All patients who are referred for coronary angiography and require physiological assessment of intermediate lesions will have both RFR and iFR measured during their standard of care procedure. Both the RFR wire (St. Jude Medical (SJM) Aeris Pressure Wire System) and iFR (Volcano Verrata Pressure Wire) wire will be advanced across the lesion with the sensor located at least 3 cm distal from the lesion.~Volcano Verrata Pressure Wire: Steerable guidewire with a pressure transducer mounted 3cm proximal to the tip. The guidewire has a diameter of 0.014.~and is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.~St. Jude Medical (SJM) Aeris Pressure Wire System: The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters."
11358812|NCT03461705|OG000|Outcome|Primary|"All patients who are referred for coronary angiography and require physiological assessment of intermediate lesions will have both RFR and iFR measured during their standard of care procedure. Both the RFR wire (St. Jude Medical (SJM) Aeris Pressure Wire System) and iFR (Volcano Verrata Pressure Wire) wire will be advanced across the lesion with the sensor located at least 3 cm distal from the lesion.~Volcano Verrata Pressure Wire: Steerable guidewire with a pressure transducer mounted 3cm proximal to the tip. The guidewire has a diameter of 0.014.~and is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.~St. Jude Medical (SJM) Aeris Pressure Wire System: The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters."
11358813|NCT03461705|EG000|Reported Event|Primary|"All patients who are referred for coronary angiography and require physiological assessment of intermediate lesions will have both RFR and iFR measured during their standard of care procedure. Both the RFR wire (St. Jude Medical (SJM) Aeris Pressure Wire System) and iFR (Volcano Verrata Pressure Wire) wire will be advanced across the lesion with the sensor located at least 3 cm distal from the lesion.~Volcano Verrata Pressure Wire: Steerable guidewire with a pressure transducer mounted 3cm proximal to the tip. The guidewire has a diameter of 0.014.~and is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.~St. Jude Medical (SJM) Aeris Pressure Wire System: The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters."
11186286|NCT02100124|EG001|Reported Event|Reproductive Life Planning Plus (RLP+)|"RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.~Reproductive Life Planning (RLP)~Contraceptive Action Planning~Contraception information"
11186287|NCT02100124|EG002|Reported Event|Information-only Control|"The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.~Contraception information"
11186288|NCT02100189|BG000|Baseline|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
11186289|NCT02100189|FG000|Participant Flow|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
11186290|NCT02100189|OG000|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
11186291|NCT02100189|EG000|Reported Event|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
11186292|NCT02100228|BG000|Baseline|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
10961899|NCT00863434|BG000|Baseline|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
10961900|NCT00863434|FG000|Participant Flow|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
10961901|NCT00863434|OG000|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
10961902|NCT00863434|EG000|Reported Event|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
10961903|NCT00863551|BG000|Baseline|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
10961904|NCT00863551|FG000|Participant Flow|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
10961905|NCT00863551|OG000|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
10961906|NCT00863551|EG000|Reported Event|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
10961907|NCT00863655|BG000|Baseline|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
11186293|NCT02100228|BG001|Baseline|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
11186294|NCT02100228|BG002|Baseline|Total|Total of all reporting groups
11186295|NCT02100228|FG000|Participant Flow|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
11186296|NCT02100228|FG001|Participant Flow|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
11186297|NCT02100228|OG000|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
11186298|NCT02100228|OG001|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
11186299|NCT02100228|EG000|Reported Event|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
11358814|NCT03457818|BG000|Baseline|Treatment Group|"Denosumab 60 mg/ml [Prolia] SC at baseline and 6 months.~Denosumab 60 mg/ml [Prolia]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits"
11358815|NCT03457818|BG001|Baseline|Control Group|"Placebo SC at Baseline and 6 months.~Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits"
11358816|NCT03457818|BG002|Baseline|Total|Total of all reporting groups
10961908|NCT00863655|BG001|Baseline|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
11237658|NCT02457520|OG000|Outcome|Single Treatment Arm-Inflammatory|"Change from Baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237659|NCT02457520|OG001|Outcome|Single Treatment Arm -Non-inflammatory|"Change from Baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237660|NCT02457520|OG002|Outcome|Single Treatment Arm- Total|"Change from Baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237661|NCT02457520|OG000|Outcome|Single Treatment Arm|"Change from Baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237662|NCT02457520|OG000|Outcome|Single Treatment Arm- Visit 14/ Week 124|"Change from Baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237663|NCT02457520|OG000|Outcome|Single Treatment Arm-Self Perception|"Change from Baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237664|NCT02457520|OG001|Outcome|Single Treatment Arm-Role-Emotional|"Change from Baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237665|NCT02457520|OG002|Outcome|Single Treatment Arm-Role-Social|"Change from Baseline~ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.~Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks"
11237666|NCT02457520|OG003|Outcome|Single Treatment Arm-Acne Symptoms|Change from Baseline
11237667|NCT02457520|EG000|Reported Event|Single Treatment Arm|"Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.~Study ABS1517LT was a Phase 4, open-label, single-arm study in subjects with severe recalcitrant nodular acne, consisting of 2 phases: a 20-week (5-month) Active Treatment Phase and a 104-week (2-year) Post Treatment Period."
11237668|NCT02457546|BG000|Baseline|Evicel|EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
11237669|NCT02457546|BG001|Baseline|DuraSeal|DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
11237670|NCT02457546|BG002|Baseline|Total|Total of all reporting groups
11237671|NCT02457546|FG000|Participant Flow|Evicel|EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
11237672|NCT02457546|FG001|Participant Flow|DuraSeal|DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
11237673|NCT02457546|OG000|Outcome|Evicel|EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
11237674|NCT02457546|OG001|Outcome|DuraSeal|DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
11237675|NCT02457546|EG000|Reported Event|Evicel|EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
11237676|NCT02457546|EG001|Reported Event|DuraSeal|DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
11237677|NCT02457611|BG000|Baseline|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
11237678|NCT02457611|FG000|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks
11237679|NCT02457611|OG000|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
11237680|NCT02457611|EG000|Reported Event|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
11237681|NCT02457637|BG000|Baseline|Acute-on-Chronic Liver Disease Inpatients|"chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients.~ALI(acute liver injury): including [ALT>3NL(normal level),AST>3NL or TB>2NL within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB>5NL) within 1 month before enrollment)].~Standary therapy for chronic liver disease with ATI and/or AD."
11186300|NCT02100228|EG001|Reported Event|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
11186301|NCT02100280|BG000|Baseline|Deep Block|"After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.~deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block"
11186302|NCT02100280|BG001|Baseline|Moderate Block|After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11186303|NCT02100280|BG002|Baseline|Total|Total of all reporting groups
11358817|NCT03457818|FG000|Participant Flow|Treatment Group|"Denosumab 60 mg/ml [Prolia] SC at baseline and 6 months.~Denosumab 60 mg/ml [Prolia]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits"
11358818|NCT03457818|FG001|Participant Flow|Control Group|"Placebo SC at Baseline and 6 months.~Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits"
11358819|NCT03457818|OG000|Outcome|Treatment Group|"Denosumab 60 mg/ml [Prolia] SC at baseline and 6 months.~Denosumab 60 mg/ml [Prolia]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits"
11358820|NCT03457818|OG001|Outcome|Control Group|"Placebo SC at Baseline and 6 months.~Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits"
11358821|NCT03457818|EG000|Reported Event|Treatment Group|"Denosumab 60 mg/ml [Prolia] SC at baseline and 6 months.~Denosumab 60 mg/ml [Prolia]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits"
11358822|NCT03457818|EG001|Reported Event|Control Group|"Placebo SC at Baseline and 6 months.~Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits"
10961909|NCT00863655|BG002|Baseline|Total|Total of all reporting groups
11358823|NCT03455556|BG000|Baseline|Treatment (Anetumab Ravtansine, Atezolizumab)|Participants receive 5.5 mg/kg anetumab ravtansine IV over 60 minutes and 1200 mg atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11358824|NCT03455556|FG000|Participant Flow|Treatment (Anetumab Ravtansine, Atezolizumab)|Participants receive 5.5 mg/kg anetumab ravtansine IV over 60 minutes and 1200 mg atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11358825|NCT03455556|OG000|Outcome|Treatment (Anetumab Ravtansine, Atezolizumab)|Participants receive 5.5 mg/kg anetumab ravtansine IV over 60 minutes and 1200 mg atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11358826|NCT03455556|EG000|Reported Event|Treatment (Anetumab Ravtansine, Atezolizumab)|Participants receive 5.5 mg/kg anetumab ravtansine IV over 60 minutes and 1200 mg atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11358827|NCT03447639|BG000|Baseline|Povidone-Iodine Irrigation|"Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal~Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique"
11358828|NCT03447639|BG001|Baseline|Standard of Care|Catheter removal with no bladder irrigation
11358829|NCT03447639|BG002|Baseline|Total|Total of all reporting groups
11358830|NCT03447639|FG000|Participant Flow|Povidone-Iodine Irrigation|"Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal~Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique"
11358831|NCT03447639|FG001|Participant Flow|Standard of Care|Catheter removal with no bladder irrigation
11358832|NCT03447639|OG000|Outcome|Povidone-Iodine Irrigation|"Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal~Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique"
11358833|NCT03447639|OG001|Outcome|Standard of Care|Catheter removal with no bladder irrigation
11358834|NCT03447639|EG000|Reported Event|Povidone-Iodine Irrigation|"Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal~Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique"
11358835|NCT03447639|EG001|Reported Event|Standard of Care|Catheter removal with no bladder irrigation
11358836|NCT03429712|BG000|Baseline|Dose Split CT|Dual-source multi-detector computed tomography (DSSE): Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications.
11186304|NCT02100280|FG000|Participant Flow|Deep Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.
11186305|NCT02100280|FG001|Participant Flow|Moderate Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11186306|NCT02100280|OG000|Outcome|Deep Block|"After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.~deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block"
11186307|NCT02100280|OG001|Outcome|Moderate Block|After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11186308|NCT02100280|OG000|Outcome|Deep Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.
11186309|NCT02100280|OG001|Outcome|Moderate Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11186310|NCT02100280|EG000|Reported Event|Deep Block|"After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.~deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block"
11186311|NCT02100280|EG001|Reported Event|Moderate Block|After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11186312|NCT02100319|BG000|Baseline|Azilsartan 20 to 40 mg|Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11186313|NCT02100319|FG000|Participant Flow|Azilsartan 20 to 40 mg|Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11186314|NCT02100319|OG000|Outcome|Azilsartan 20 to 40 mg|Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11186315|NCT02100319|EG000|Reported Event|Azilsartan 20 to 40 mg|Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
11186316|NCT02100410|BG000|Baseline|Overall|All treatment sequences
11186317|NCT02100410|FG000|Participant Flow|Sequence 1|T1 and T2; T3 and T4; T5 and T6
11186318|NCT02100410|FG001|Participant Flow|Sequence 2|T1 and T2; T5 and T6; T3 and T4
11186319|NCT02100410|FG002|Participant Flow|Sequence 3|T3 and T4; T1 and T2; T5 and T6
11186320|NCT02100410|FG003|Participant Flow|Sequence 4|T3 and T4; T5 and T6; T1 and T2
11186321|NCT02100410|FG004|Participant Flow|Sequence 5|T5 and T6; T1 and T2; T3 and T4
11186322|NCT02100410|FG005|Participant Flow|Sequence 6|T5 and T6; T3 and T4; T1 and T2
11186323|NCT02100410|OG000|Outcome|TEST1|Iteration 2-87-1 with embossed mark
11186324|NCT02100410|OG001|Outcome|TEST3|Iteration 2-87-2 with embossed mark
11186325|NCT02100410|OG002|Outcome|TEST5|Iteration 2-87-3 with embossed mark
11186326|NCT02100410|OG001|Outcome|TEST2|Iteration 2-87-1 without embossed mark
11186327|NCT02100410|OG002|Outcome|TEST3|Iteration 2-87-2 with embossed mark
11186328|NCT02100410|OG003|Outcome|TEST4|Iteration 2-87-2 without embossed mark
11186329|NCT02100410|OG004|Outcome|TEST5|Iteration 2-87-3 with embossed mark
11186330|NCT02100410|OG005|Outcome|TEST6|Iteration 2-87-3 without embossed mark
11186331|NCT02100410|EG000|Reported Event|TEST (1,3,5)|Delefilcon A toric contact lenses with embossed mark, 3 different iterations, crossover all on the same eye
11186332|NCT02100410|EG001|Reported Event|TEST (2,4,6)|Delefilcon A toric contact lenses without embossed mark, 3 different iterations, crossover all on the same eye
11186333|NCT02100475|BG000|Baseline|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
11358837|NCT03429712|FG000|Participant Flow|Dose Split CT|Dual-source multi-detector computed tomography (DSSE): Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications.
11358838|NCT03429712|OG000|Outcome|Dose Split CT|Dual-source multi-detector computed tomography (DSSE): Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications.
11358839|NCT03429712|EG000|Reported Event|Dose Split CT|Dual-source multi-detector computed tomography (DSSE): Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications.
11358840|NCT03426137|BG000|Baseline|Full Dose (FD)|"Participants in the FD arm will receive NSAIDs and Oxycodone (5mg).dosed in accordance with the Guidelines for Use from University of Maryland Shock Trauma Center.~Oxycodone: 5mg Oxycodone in oral solution given every 3 hours~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain."
11358841|NCT03426137|BG001|Baseline|PR (Partial Reinforcement)|"Participants in this group will receive NSAIDs, Oxycodone (5mg), and placebo pills to reach a 50% reduction of the total intake of opioids.~Oxycodone: 5mg Oxycodone in oral solution given every 3 hours~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.~Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet"
11358842|NCT03426137|BG002|Baseline|C (Control)|"Participants in this group will receive NSAIDs and placebo pills~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.~Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet"
11358843|NCT03426137|BG003|Baseline|Total|Total of all reporting groups
11358844|NCT03426137|FG000|Participant Flow|Full Dose (FD)|"Participants in the FD arm will receive NSAIDs and Oxycodone (5mg).dosed in accordance with the Guidelines for Use from University of Maryland Shock Trauma Center.~Oxycodone: 5mg Oxycodone in oral solution given every 3 hours~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain."
11358845|NCT03426137|FG001|Participant Flow|PR (Partial Reinforcement)|"Participants in this group will receive NSAIDs, Oxycodone (5mg), and placebo pills to reach a 50% reduction of the total intake of opioids.~Oxycodone: 5mg Oxycodone in oral solution given every 3 hours~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.~Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet"
10961910|NCT00863655|FG000|Participant Flow|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
11358846|NCT03426137|FG002|Participant Flow|C (Control)|"Participants in this group will receive NSAIDs and placebo pills~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.~Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet"
11358847|NCT03426137|OG000|Outcome|Full Dose (FD)|"Participants in the FD arm will receive NSAIDs and Oxycodone (5mg).dosed in accordance with the Guidelines for Use from University of Maryland Shock Trauma Center.~Oxycodone: 5mg Oxycodone in oral solution given every 3 hours~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain."
11358848|NCT03426137|OG001|Outcome|PR (Partial Reinforcement)|"Participants in this group will receive NSAIDs, Oxycodone (5mg), and placebo pills to reach a 50% reduction of the total intake of opioids.~Oxycodone: 5mg Oxycodone in oral solution given every 3 hours~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.~Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet"
11358849|NCT03426137|OG002|Outcome|C (Control)|"Participants in this group will receive NSAIDs and placebo pills~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.~Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet"
11237682|NCT02457637|FG000|Participant Flow|Acute-on-Chronic Liver Disease Inpatients|"chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.~ALI(acute liver injury): including [ALT>3NL(normal level),AST>3NL or TB>2NL within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB>5NL) within 1 month before enrollment)]~Standary therapy for chronic liver disease with ATI and/or AD"
11237683|NCT02457637|OG000|Outcome|Acute-on-Chronic Liver Disease|"chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.~ALI(acute liver injury): including [ALT>3NL(normal level),AST>3NL or TB>2NL within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB>5NL) within 1 month before enrollment)]~Standary therapy for chronic liver disease with ATI and/or AD"
11237684|NCT02457637|OG000|Outcome|Acute-on-Chronic Liver Disease Inpatients|"chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.~ALI(acute liver injury): including [ALT>3NL(normal level),AST>3NL or TB>2NL within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB>5NL) within 1 month before enrollment)]~Standary therapy for chronic liver disease with ATI and/or AD"
11237685|NCT02457637|EG000|Reported Event|Acute-on-Chronic Liver Disease|"chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients; and non-alcoholic fatty liver disease patients.~ALI(acute liver injury): including [ALT>3NL(normal level),AST>3NL or TB>2NL within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection gastrointestinal bleeding or jaundice(TB>5NL)within 1 month before enrollment)].~Standary therapy"
11237686|NCT02457728|BG000|Baseline|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.~LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TransAbdominalPrePeritoneal (TAPP) repair."
11237687|NCT02457728|FG000|Participant Flow|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.~LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair."
11237688|NCT02457728|OG000|Outcome|Single-port TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair using a single-port approach.
11237689|NCT02457728|EG000|Reported Event|TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
11240787|NCT02481869|OG001|Outcome|Saline|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.~Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.~Arthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation"
11240788|NCT02481869|OG000|Outcome|Platelet Rich Plasma|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.~Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.~Arthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s"
11240789|NCT02481869|EG000|Reported Event|Platelet Rich Plasma|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.~Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.~Arthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s"
11336597|NCT03569098|BG001|Baseline|Dysport 300 U|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
10961911|NCT00863655|FG001|Participant Flow|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
10961912|NCT00863655|OG000|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
11358850|NCT03426137|EG000|Reported Event|Full Dose (FD)|"Participants in the FD arm will receive NSAIDs and Oxycodone (5mg).dosed in accordance with the Guidelines for Use from University of Maryland Shock Trauma Center.~Oxycodone: 5mg Oxycodone in oral solution given every 3 hours~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain."
11358851|NCT03426137|EG001|Reported Event|PR (Partial Reinforcement)|"Participants in this group will receive NSAIDs, Oxycodone (5mg), and placebo pills to reach a 50% reduction of the total intake of opioids.~Oxycodone: 5mg Oxycodone in oral solution given every 3 hours~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.~Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet"
11358852|NCT03426137|EG002|Reported Event|C (Control)|"Participants in this group will receive NSAIDs and placebo pills~Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.~Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet"
11358853|NCT03425799|BG000|Baseline|Sodium Chloride 0.9%|"Sodium Chloride 0.9% infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg~Sodium Chloride 0.9% Inj: Inactive ingredient mixture for injection without drug, intravenous infusion bags containing normal saline, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot."
11358854|NCT03425799|BG001|Baseline|Tranexamic Acid 10 mg/mL|"Tranexamic Acid 10 mg/mL infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg~Tranexamic Acid: Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot."
11358855|NCT03425799|BG002|Baseline|Total|Total of all reporting groups
11358856|NCT03425799|FG000|Participant Flow|Tranexamic Acid 10 mg/mL|"Tranexamic Acid 10 mg/mL infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg~Tranexamic Acid: Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot."
11358857|NCT03425799|FG001|Participant Flow|Placebo|"Placebo (0.9% Sodium Chloride) infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg~Placebo Intravenous Infusion Bags, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot."
11358858|NCT03425799|OG000|Outcome|Sodium Chloride 0.9%|"Sodium Chloride 0.9% infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg~Sodium Chloride 0.9% Inj: Inactive ingredient mixture for injection without drug, intravenous infusion bags containing normal saline, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot."
11358859|NCT03425799|OG001|Outcome|Tranexamic Acid 10 mg/mL|"Tranexamic Acid 10 mg/mL infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg~Tranexamic Acid: Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot."
10961913|NCT00863655|OG001|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
11358860|NCT03425799|EG000|Reported Event|Sodium Chloride 0.9%|"Sodium Chloride 0.9% infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg~Sodium Chloride 0.9% Inj: Inactive ingredient mixture for injection without drug, intravenous infusion bags containing normal saline, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot."
11358861|NCT03425799|EG001|Reported Event|Tranexamic Acid 10 mg/mL|"Tranexamic Acid 10 mg/mL infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg~Tranexamic Acid: Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot."
11358862|NCT03423654|BG000|Baseline|Training Group|"Spatial training~Spatial Training: Spatial Training using a 5x5 grid"
11358863|NCT03423654|BG001|Baseline|Control Group|"Letter number matching~Letter number matching: Letter number matching"
11358864|NCT03423654|BG002|Baseline|Total|Total of all reporting groups
11358865|NCT03423654|FG000|Participant Flow|Training Group|"Spatial training~Spatial Training: Spatial Training using a 5x5 grid"
11358866|NCT03423654|FG001|Participant Flow|Control Group|"Letter number matching~Letter number matching: Letter number matching"
11358867|NCT03423654|OG000|Outcome|Training Group|"Spatial training~Spatial Training: Spatial Training using a 5x5 grid"
11358868|NCT03423654|OG001|Outcome|Control Group|"Letter number matching~Letter number matching: Letter number matching"
11358869|NCT03423654|EG000|Reported Event|Training Group|"Spatial training~Spatial Training: Spatial Training using a 5x5 grid"
11358870|NCT03423654|EG001|Reported Event|Control Group|"Letter number matching~Letter number matching: Letter number matching"
11358871|NCT03387059|BG000|Baseline|Forielle Endometrial Washing|Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
11358872|NCT03387059|BG001|Baseline|No Endometrial Washing|Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
11358873|NCT03387059|BG002|Baseline|Total|Total of all reporting groups
11358874|NCT03387059|FG000|Participant Flow|Forielle Endometrial Washing|Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
11358875|NCT03387059|FG001|Participant Flow|No Endometrial Washing|Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
11358876|NCT03387059|OG000|Outcome|Forielle Endometrial Washing|Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
11358877|NCT03387059|OG001|Outcome|No Endometrial Washing|Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
11358878|NCT03387059|EG000|Reported Event|Forielle Endometrial Washing|Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
11358879|NCT03387059|EG001|Reported Event|No Endometrial Washing|Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
11358880|NCT03382925|BG000|Baseline|Cervical Interlaminar With Lidocaine|"Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL).~cervical interlaminar with lidocaine: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.~Lidocaine: 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.~Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures."
11358881|NCT03382925|BG001|Baseline|Cervical Interlaminar With Normal Saline|"Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL).~cervical interlaminar with normal saline: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline~Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.~Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure."
11358882|NCT03382925|BG002|Baseline|Total|Total of all reporting groups
11358883|NCT03382925|FG000|Participant Flow|Cervical Interlaminar With Lidocaine|"Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL).~cervical interlaminar with lidocaine: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.~Lidocaine: 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.~Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures."
11358884|NCT03382925|FG001|Participant Flow|Cervical Interlaminar With Normal Saline|"Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL).~cervical interlaminar with normal saline: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline~Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.~Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure."
11358885|NCT03382925|OG000|Outcome|Cervical Interlaminar With Lidocaine|"Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL).~cervical interlaminar with lidocaine: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.~Lidocaine: 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.~Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures."
11358886|NCT03382925|OG001|Outcome|Cervical Interlaminar With Normal Saline|"Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL).~cervical interlaminar with normal saline: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline~Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.~Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure."
11358887|NCT03382925|EG000|Reported Event|Cervical Interlaminar With Lidocaine|"Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL).~cervical interlaminar with lidocaine: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.~Lidocaine: 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.~Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures."
11358888|NCT03382925|EG001|Reported Event|Cervical Interlaminar With Normal Saline|"Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL).~cervical interlaminar with normal saline: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline~Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.~Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure."
11358889|NCT03379233|BG000|Baseline|Telehealth Group|Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
11358890|NCT03379233|BG001|Baseline|Usual Care Group|Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
11358891|NCT03379233|BG002|Baseline|Total|Total of all reporting groups
11358892|NCT03379233|FG000|Participant Flow|Telehealth Group|Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
11358893|NCT03379233|FG001|Participant Flow|Usual Care Group|Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
10961914|NCT00863655|EG000|Reported Event|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
11237690|NCT02457793|BG000|Baseline|Not Assigned|One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
11237691|NCT02457793|BG001|Baseline|COB 20 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237692|NCT02457793|BG002|Baseline|COB 40 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237693|NCT02457793|BG003|Baseline|COB 80 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237694|NCT02457793|BG004|Baseline|COB 80 mg + GDC 400 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
11237695|NCT02457793|BG005|Baseline|COB 100 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237696|NCT02457793|BG006|Baseline|Total|Total of all reporting groups
11237697|NCT02457793|FG000|Participant Flow|Not Assigned|One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
11237698|NCT02457793|FG001|Participant Flow|COB 20 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237699|NCT02457793|FG002|Participant Flow|COB 40 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237700|NCT02457793|FG003|Participant Flow|COB 80 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237701|NCT02457793|FG004|Participant Flow|COB 80 mg + GDC 400 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
11237702|NCT02457793|FG005|Participant Flow|COB 100 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237703|NCT02457793|OG000|Outcome|Not Assigned|One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
11237704|NCT02457793|OG001|Outcome|COB 20 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237705|NCT02457793|OG002|Outcome|COB 40 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237706|NCT02457793|OG003|Outcome|COB 80 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237707|NCT02457793|OG004|Outcome|COB 80 mg + GDC 400 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
11237708|NCT02457793|OG005|Outcome|COB 100 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237709|NCT02457793|OG000|Outcome|COB 80 mg + GDC 300 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
11237710|NCT02457793|EG000|Reported Event|Not Assigned|One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
11237711|NCT02457793|EG001|Reported Event|COB 20 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237712|NCT02457793|EG002|Reported Event|COB 40 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237713|NCT02457793|EG003|Reported Event|COB 80 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237714|NCT02457793|EG004|Reported Event|COB 80 mg + GDC 400 mg|Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
11237715|NCT02457793|EG005|Reported Event|COB 100 mg + GDC 200 mg|Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
11237716|NCT02457819|BG000|Baseline|Dasotraline|Dasotraline 2, 4, 6 mg, flexibly dosed
11237717|NCT02457819|FG000|Participant Flow|Dasotraline|Dasotraline 2, 4, 6 mg, flexibly dosed
11237718|NCT02457819|OG000|Outcome|Dasotraline|Dasotraline 2, 4, 6 mg, flexibly dosed
11237719|NCT02457819|EG000|Reported Event|Dasotraline|Dasotraline 2, 4, 6 mg, flexibly dosed
11237720|NCT02457897|BG000|Baseline|Patients With Insulin Receptor Mutation|Liothyronine: Oral supplement given every 8 hours
11237721|NCT02457897|FG000|Participant Flow|Patients With Insulin Receptor Mutation|Liothyronine: Oral supplement given every 8 hours
11237722|NCT02457897|OG000|Outcome|Patients With Insulin Receptor Mutation|Liothyronine: Oral supplement given every 8 hours
11237723|NCT02457897|EG000|Reported Event|Patients With Insulin Receptor Mutation|Liothyronine: Oral supplement given every 8 hours
11237724|NCT02458092|BG000|Baseline|50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant|Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
11237725|NCT02458092|BG001|Baseline|Rabies Vaccine Rabipur|Rabipur: Rabipur is a licensed rabies vaccine.
11237726|NCT02458092|BG002|Baseline|Total|Total of all reporting groups
11237727|NCT02458092|FG000|Participant Flow|50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant|Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
11237728|NCT02458092|FG001|Participant Flow|Rabies Vaccine Rabipur|Rabipur: Rabipur is a licensed rabies vaccine (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
11237729|NCT02458092|OG000|Outcome|50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant|Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
11237730|NCT02458092|OG001|Outcome|Rabies Vaccine Rabipur|Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
11237731|NCT02458092|OG000|Outcome|Rabies Vaccine Rabipur|Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
11237732|NCT02458092|EG000|Reported Event|50 µg of FMP010 Antigen in 0.5 mL AS01B Adjuvant|"50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant given intramuscularly in the deltoid muscle of the non-dominant arm.~Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK"
11237733|NCT02458092|EG001|Reported Event|Rabies Vaccine Rabipur|"Rabies Vaccine Rabipur given intramuscularly in the deltoid muscle of the non-dominant arm.~Rabipur: Rabipur is a licensed rabies vaccine."
11237734|NCT02458235|BG000|Baseline|Azacitidine/Donor Lymphocyte Infusion|"Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI.~azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals~donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle."
11237735|NCT02458235|FG000|Participant Flow|Azacitidine/Donor Lymphocyte Infusion|"Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI.~azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals~donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle."
11237736|NCT02458235|OG000|Outcome|Azacitidine/Donor Lymphocyte Infusion|"Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI.~azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals~donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle."
11237737|NCT02458235|EG000|Reported Event|Azacitidine/Donor Lymphocyte Infusion|"Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI.~azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals~donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle."
11237738|NCT02458287|BG000|Baseline|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
11237739|NCT02458287|BG001|Baseline|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237740|NCT02458287|BG002|Baseline|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237741|NCT02458287|BG003|Baseline|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
10961915|NCT00863655|EG001|Reported Event|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
11237742|NCT02458287|BG004|Baseline|Total|Total of all reporting groups
11237743|NCT02458287|FG000|Participant Flow|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
11237744|NCT02458287|FG001|Participant Flow|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237745|NCT02458287|FG002|Participant Flow|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237746|NCT02458287|FG003|Participant Flow|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237747|NCT02458287|OG000|Outcome|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
11237748|NCT02458287|OG001|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237749|NCT02458287|OG000|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237750|NCT02458287|OG000|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237751|NCT02458287|OG001|Outcome|Bococizumab 150 mg + Bococizumab 75 mg|Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237752|NCT02458287|OG001|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237753|NCT02458287|OG002|Outcome|Bococizumab 150 + Bococizumab 75 mg|Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237754|NCT02458287|OG000|Outcome|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
11237755|NCT02458287|OG002|Outcome|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237756|NCT02458287|OG003|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237757|NCT02458287|EG000|Reported Event|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
11237758|NCT02458287|EG001|Reported Event|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237759|NCT02458287|EG002|Reported Event|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237760|NCT02458287|EG003|Reported Event|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
11237761|NCT02458352|BG000|Baseline|Standard Dose CT, Ultra-low Dose CT|"Standard dose non-contrast enhanced CT~Standard dose non-contrast enhanced CT: Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol"
11237762|NCT02458352|FG000|Participant Flow|Standard Dose CT, Ultra-low Dose CT|"Standard dose and ultra-low dose non-contrast enhanced CT~Standard dose non-contrast enhanced CT: Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol Ultra-low dose non-contrast enhanced CT: Additional scan as part of the trial"
11237763|NCT02458352|OG000|Outcome|Standard Dose CT|"Standard dose non-contrast enhanced CT~Standard dose non-contrast enhanced CT: Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol"
11237764|NCT02458352|OG001|Outcome|Ultra-low Dose CT|"Ultra low dose non-contrast enhanced CT~Ultra low dose non-contrast enhanced CT: Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure"
11237765|NCT02458352|EG000|Reported Event|Standard Dose CT|"Standard dose non-contrast enhanced CT~Standard dose non-contrast enhanced CT: Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol"
11237766|NCT02458352|EG001|Reported Event|Ultra-low Dose CT|"Ultra low dose non-contrast enhanced CT~Ultra low dose non-contrast enhanced CT: Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure"
11237767|NCT02458365|BG000|Baseline|Intevention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
11358894|NCT03379233|OG000|Outcome|Telehealth Group|Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
11358895|NCT03379233|OG001|Outcome|Usual Care Group|Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
11358896|NCT03379233|EG000|Reported Event|Telehealth Group|Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
11358897|NCT03379233|EG001|Reported Event|Usual Care Group|Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
11358898|NCT03370536|BG000|Baseline|Patients With Atrial Fibrillation (AF)|Patients with AF and planned to undergo first catheter procedure
11358899|NCT03370536|FG000|Participant Flow|Patients With AF|"Patients with AF and planned to undergo first catheter procedure~CardioInsight ECGI Mapping System: The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.~AF ablation: Empiric ablation (CFAE or linear ablation) is not permitted~Ibutilide: Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)"
11358900|NCT03370536|OG000|Outcome|Patients With Atrial Fibrillation (AF)|Patients with AF and planned to undergo first catheter procedure
11358901|NCT03370536|EG000|Reported Event|Patients With Atrial Fibrillation (AF)|Patients with AF and planned to undergo first catheter procedure
11358902|NCT03363633|BG000|Baseline|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
11358903|NCT03363633|FG000|Participant Flow|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
11358904|NCT03363633|OG000|Outcome|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
11358905|NCT03363633|EG000|Reported Event|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
11358906|NCT03361228|BG000|Baseline|INCB001158 50mg BID+ Epacadostat + Pembrolizumab|INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
11358907|NCT03361228|BG001|Baseline|INCB001158 75 mg BID + Epacadostat + Pembrolizumab|INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
11358908|NCT03361228|BG002|Baseline|Total|Total of all reporting groups
11358909|NCT03361228|FG000|Participant Flow|INCB001158 50mg BID+ Epacadostat + Pembrolizumab|INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
11358910|NCT03361228|FG001|Participant Flow|INCB001158 75 mg BID + Epacadostat + Pembrolizumab|INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
11358911|NCT03361228|OG000|Outcome|INCB001158 50mg BID+ Epacadostat + Pembrolizumab|INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
11358912|NCT03361228|OG001|Outcome|INCB001158 75 mg BID + Epacadostat + Pembrolizumab|INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
11358913|NCT03361228|EG000|Reported Event|INCB001158 50mg BID+ Epacadostat + Pembrolizumab|INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
11358914|NCT03361228|EG001|Reported Event|INCB001158 75 mg BID + Epacadostat + Pembrolizumab|INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
11358915|NCT03360903|BG000|Baseline|Placebo Then Caffeine|"Anesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg).~Placebo: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).~Other Names:~Saline~Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).~Other Names:~Caffeine citrate"
11358916|NCT03360903|BG001|Baseline|Caffeine Then Placebo|"Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control).~Placebo: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).~Other Names:~Saline~Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).~Other Names:~Caffeine citrate"
11358917|NCT03360903|BG002|Baseline|Total|Total of all reporting groups
11358918|NCT03360903|FG000|Participant Flow|Placebo Then Caffeine|"Anesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg).~Placebo: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).~Other Names:~Saline~Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).~Other Names:~Caffeine citrate"
11358919|NCT03360903|FG001|Participant Flow|Caffeine Then Placebo|"Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control).~Placebo: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).~Other Names:~Saline~Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).~Other Names:~Caffeine citrate"
11358920|NCT03360903|OG000|Outcome|Placebo|Participants received a saline infusion
11358921|NCT03360903|OG001|Outcome|Caffeine|Participants received a caffiene infusion
11358922|NCT03360903|EG000|Reported Event|Placebo|Participants received a saline infusion
11358923|NCT03360903|EG001|Reported Event|Caffeine|Participants received a caffiene infusion
11358924|NCT03359174|BG000|Baseline|All-trans Retinoic Acid (ATRA) Therapy|"Fixed low dose of ATRA 10 mg twice daily for 24 weeks.~All-trans retinoic acid: Fixed low dose of ATRA 10 mg twice daily for 24 weeks."
11358925|NCT03359174|FG000|Participant Flow|All-trans Retinoic Acid (ATRA) Therapy|"Fixed low dose of ATRA 10 mg twice daily for 24 weeks.~All-trans retinoic acid: Fixed low dose of ATRA 10 mg twice daily for 24 weeks."
11237768|NCT02458365|BG001|Baseline|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
11237769|NCT02458365|BG002|Baseline|Total|Total of all reporting groups
11237770|NCT02458365|FG000|Participant Flow|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
11237771|NCT02458365|FG001|Participant Flow|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
11237772|NCT02458365|OG000|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
11237773|NCT02458365|OG001|Outcome|Comparison: Health in Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
11237774|NCT02458365|OG001|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
11237775|NCT02458365|EG000|Reported Event|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
11237776|NCT02458365|EG001|Reported Event|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
11237777|NCT02458469|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Buspirone (7.5-15 mg) or Trazodone (100 mg) or Placebo tablet
11237778|NCT02458469|FG000|Participant Flow|Placebo->Buspirone->Trazodone|Participants first received a placebo taken once daily for two weeks. After a washout period of two weeks, the participants then received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After another washout period of two weeks, participants received trazodone (100 mg) once daily for two weeks.
11237779|NCT02458469|FG001|Participant Flow|Placebo->Trazodone->Buspirone|Participants first received a placebo taken once daily for two weeks. After a washout period of two weeks, the participants then received trazodone (100 mg) once daily for two weeks. After another washout period of two weeks, participants received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks.
11237780|NCT02458469|FG002|Participant Flow|Buspirone->Trazodone->Placebo|Participants first received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After a washout period of two weeks, the participants then received trazodone (100 mg) once daily for two weeks. After another washout period of two weeks, participants received a placebo taken once daily for two weeks.
11237781|NCT02458469|FG003|Participant Flow|Buspirone->Placebo->Trazodone|Participants first received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After a washout period of two weeks, the participants then received a placebo taken once daily for two weeks. After another washout period of two weeks, participants received trazodone (100 mg) once daily for two weeks.
11237782|NCT02458469|FG004|Participant Flow|Trazodone->Placebo->Buspirone|Participants first received trazodone (100 mg) once daily for two weeks. After a washout period of two weeks, the participants then received a placebo taken once daily for two weeks. After another washout period of two weeks, participants received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks.
11237783|NCT02458469|FG005|Participant Flow|Trazodone->Buspirone->Placebo|Participants first received trazodone (100 mg) once daily for two weeks. After a washout period of two weeks, the participants then received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After another washout period of two weeks, participants received a placebo taken once daily for two weeks.
11237784|NCT02458469|OG000|Outcome|Buspirone|"This drug will be taken for two week period~Buspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached."
11237785|NCT02458469|OG001|Outcome|Trazodone|"This drug will be taken for two week period~Trazodone: 100 mg dose before bed-time"
11237786|NCT02458469|OG002|Outcome|Placebo|"A placebo pill will be taken at bed time for two week period~Placebo: One placebo pill before bed-time"
11237787|NCT02458469|EG000|Reported Event|Buspirone|"This drug will be taken for two week period~Buspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached."
11237788|NCT02458469|EG001|Reported Event|Trazodone|"This drug will be taken for two week period~Trazodone: 100 mg dose before bed-time"
11237789|NCT02458469|EG002|Reported Event|Placebo|"A placebo pill will be taken at bed time for two week period~Placebo: One placebo pill before bed-time"
11237790|NCT02458638|BG000|Baseline|Atezolizumab|Atezolizumab 1200 milligrams (mg) was administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
11237791|NCT02458638|FG000|Participant Flow|Atezolizumab|Atezolizumab 1200 milligrams (mg) was administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
11237792|NCT02458638|OG000|Outcome|Atezolizumab|Atezolizumab 1200 milligrams (mg) was administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
11237793|NCT02458638|EG000|Reported Event|Atezolizumab|Atezolizumab 1200 milligrams (mg) was administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
11237794|NCT02458690|BG000|Baseline|eIMPACT|eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.
11237795|NCT02458690|BG001|Baseline|Usual Care|Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
11237796|NCT02458690|BG002|Baseline|Total|Total of all reporting groups
11237797|NCT02458690|FG000|Participant Flow|eIMPACT|eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.
11237798|NCT02458690|FG001|Participant Flow|Usual Care|Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
11237799|NCT02458690|OG000|Outcome|eIMPACT|eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.
11237800|NCT02458690|OG001|Outcome|Usual Care|Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
11237801|NCT02458690|EG000|Reported Event|eIMPACT|eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.
11237802|NCT02458690|EG001|Reported Event|Usual Care|Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
11237803|NCT02458768|BG000|Baseline|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
11358926|NCT03359174|OG000|Outcome|All-trans Retinoic Acid (ATRA) Therapy|"Fixed low dose of ATRA 10 mg twice daily for 24 weeks.~All-trans retinoic acid: Fixed low dose of ATRA 10 mg twice daily for 24 weeks."
11358927|NCT03359174|EG000|Reported Event|All-trans Retinoic Acid (ATRA) Therapy|"Fixed low dose of ATRA 10 mg twice daily for 24 weeks.~All-trans retinoic acid: Fixed low dose of ATRA 10 mg twice daily for 24 weeks."
11358928|NCT03352882|BG000|Baseline|Open Label|"All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS.~Ultrasound: Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded."
11358929|NCT03352882|FG000|Participant Flow|Open Label|"All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS.~Ultrasound: Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded."
11358930|NCT03352882|OG000|Outcome|Open Label|"All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS.~Ultrasound: Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded."
11358931|NCT03352882|EG000|Reported Event|Open Label|"All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS.~Ultrasound: Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded."
11358932|NCT03348904|BG000|Baseline|Nivolumab + Epacadostat/Platinum Doublet Chemotherapy|"Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:~Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358933|NCT03348904|BG001|Baseline|Platinum Doublet Chemotherapy|"Platinum Doublet Chemotherapy included the following:~Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358934|NCT03348904|BG002|Baseline|Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy|"Nivolumab plus placebo in combination with platinum doublet chemotherapy included:~Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358935|NCT03348904|BG003|Baseline|Total|Total of all reporting groups
11358936|NCT03348904|FG000|Participant Flow|Nivolumab + Epacadostat/Platinum Doublet Chemotherapy|"Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:~Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358937|NCT03348904|FG001|Participant Flow|Platinum Doublet Chemotherapy|"Platinum Doublet Chemotherapy included the following:~Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11186334|NCT02100475|BG001|Baseline|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
11186335|NCT02100475|BG002|Baseline|Total|Total of all reporting groups
11186336|NCT02100475|FG000|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
11186337|NCT02100475|FG001|Participant Flow|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
11186338|NCT02100475|OG000|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
11186339|NCT02100475|OG001|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
11186340|NCT02100475|EG000|Reported Event|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
11186341|NCT02100475|EG001|Reported Event|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
11191681|NCT02132949|BG000|Baseline|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
11191682|NCT02132949|BG001|Baseline|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
11191683|NCT02132949|BG002|Baseline|Total|Total of all reporting groups
11191684|NCT02132949|FG000|Participant Flow|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
11237804|NCT02458768|BG001|Baseline|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
11237805|NCT02458768|BG002|Baseline|Total|Total of all reporting groups
11237806|NCT02458768|FG000|Participant Flow|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
11237807|NCT02458768|FG001|Participant Flow|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
11237808|NCT02458768|OG000|Outcome|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
11237809|NCT02458768|OG001|Outcome|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
11237810|NCT02458768|EG000|Reported Event|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
11237811|NCT02458768|EG001|Reported Event|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
11237812|NCT02459093|BG000|Baseline|Poliglecaprone 25 Suture|"Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery~poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture"
11237813|NCT02459093|BG001|Baseline|Polyglactin 910 Suture|"Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery~polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture"
11237814|NCT02459093|BG002|Baseline|Total|Total of all reporting groups
11237815|NCT02459093|FG000|Participant Flow|Poliglecaprone 25 Suture|"Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery~poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture"
11237816|NCT02459093|FG001|Participant Flow|Polyglactin 910 Suture|"Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery~polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture"
11237817|NCT02459093|OG000|Outcome|Poliglecaprone 25 Suture|"Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery~poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture"
11237818|NCT02459093|OG001|Outcome|Polyglactin 910 Suture|"Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery~polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture"
11237819|NCT02459093|EG000|Reported Event|Poliglecaprone 25 Suture|"Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery~poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture"
11237820|NCT02459093|EG001|Reported Event|Polyglactin 910 Suture|"Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery~polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture"
11237821|NCT02459119|BG000|Baseline|Regorafenib|"Regorafenib will be administered orally to all patients on study. The drug will be taken once a day for 3 of every 4 week cycle (3 weeks on/1 week off). The dose is 120 mg once daily for the first cycle, then 160 mg once daily from the second cycle if no significant Regorafenib-associated toxicities occur during the first cycle. Drug dosage may be modified if toxicities occur. Patients will undergo up to 4 cycles of treatment and may continue on additional at the discretion of the investigator.~Regorafenib: Regorafenib will be packaged as 40 mg tablets in a bottle. Patients will be instructed to maintain a daily medication calendar."
11237822|NCT02459119|FG000|Participant Flow|Regorafenib|"Regorafenib will be administered orally to all patients on study. The drug will be taken once a day for 3 of every 4 week cycle (3 weeks on/1 week off). The dose is 120 mg once daily for the first cycle, then 160 mg once daily from the second cycle if no significant Regorafenib-associated toxicities occur during the first cycle. Drug dosage may be modified if toxicities occur. Patients will undergo up to 4 cycles of treatment and may continue on additional at the discretion of the investigator.~Regorafenib: Regorafenib will be packaged as 40 mg tablets in a bottle. Patients will be instructed to maintain a daily medication calendar."
11237823|NCT02459119|OG000|Outcome|Regorafenib|"Regorafenib will be administered orally to all patients on study. The drug will be taken once a day for 3 of every 4 week cycle (3 weeks on/1 week off). The dose is 120 mg once daily for the first cycle, then 160 mg once daily from the second cycle if no significant Regorafenib-associated toxicities occur during the first cycle. Drug dosage may be modified if toxicities occur. Patients will undergo up to 4 cycles of treatment and may continue on additional at the discretion of the investigator.~Regorafenib: Regorafenib will be packaged as 40 mg tablets in a bottle. Patients will be instructed to maintain a daily medication calendar."
11186342|NCT02100514|BG000|Baseline|Treatment Period: Placebo|Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186343|NCT02100514|BG001|Baseline|Treatment Period: Bococizumab 150 mg|Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186344|NCT02100514|BG002|Baseline|Total|Total of all reporting groups
11186345|NCT02100514|FG000|Participant Flow|Treatment Period: Placebo|Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186346|NCT02100514|FG001|Participant Flow|Treatment Period: Bococizumab 150 mg|Participants received Bococizumab (PF-04950615) 150 milligram (mg) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186347|NCT02100514|FG002|Participant Flow|Extension Period: Placebo|Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
11186348|NCT02100514|FG003|Participant Flow|Extension Period: Bococizumab ADA Positive|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11186349|NCT02100514|FG004|Participant Flow|Extension Period: Bococizumab ADA Negative|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11186350|NCT02100514|OG000|Outcome|Treatment Period: Placebo|Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186351|NCT02100514|OG001|Outcome|Treatment Period: Bococizumab 150 mg|Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186352|NCT02100514|OG000|Outcome|Treatment Period: Bococizumab 150 mg|Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186353|NCT02100514|OG000|Outcome|Extension Period: Placebo|Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
11186354|NCT02100514|OG001|Outcome|Extension Period: Bococizumab ADA Positive|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11186355|NCT02100514|OG002|Outcome|Extension Period: Bococizumab ADA Negative|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11186356|NCT02100514|OG000|Outcome|Extension Period: Bococizumab ADA Positive|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11186357|NCT02100514|EG000|Reported Event|Treatment Period: Placebo|Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186358|NCT02100514|EG001|Reported Event|Treatment Period: Bococizumab 150 mg|Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
11186359|NCT02100514|EG002|Reported Event|Extension Period: Placebo|Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
11186360|NCT02100514|EG003|Reported Event|Extension Period: Bococizumab ADA Positive|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11186361|NCT02100514|EG004|Reported Event|Extension Period: Bococizumab ADA Negative|Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
11186362|NCT02100579|BG000|Baseline|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
11186363|NCT02100579|BG001|Baseline|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
11186364|NCT02100579|BG002|Baseline|Total|Total of all reporting groups
11237824|NCT02459119|EG000|Reported Event|Regorafenib|"Regorafenib will be administered orally to all patients on study. The drug will be taken once a day for 3 of every 4 week cycle (3 weeks on/1 week off). The dose is 120 mg once daily for the first cycle, then 160 mg once daily from the second cycle if no significant Regorafenib-associated toxicities occur during the first cycle. Drug dosage may be modified if toxicities occur. Patients will undergo up to 4 cycles of treatment and may continue on additional at the discretion of the investigator.~Regorafenib: Regorafenib will be packaged as 40 mg tablets in a bottle. Patients will be instructed to maintain a daily medication calendar."
11237825|NCT02459197|BG000|Baseline|T4P1001|"Heat Pain Stimuli A~Positive Video~Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment"
11237826|NCT02459197|BG001|Baseline|Placebo|"Heat Pain Stimuli B~Neutral Video~Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment"
11237827|NCT02459197|BG002|Baseline|Total|Total of all reporting groups
11237828|NCT02459197|FG000|Participant Flow|T4P1001|"Heat Pain Stimuli A~Positive Video~Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment"
11237829|NCT02459197|FG001|Participant Flow|Placebo|"Heat Pain Stimuli B~Neutral Video~Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment"
11237830|NCT02459197|OG000|Outcome|T4P1001|"Heat Pain Stimuli A~Positive Video~Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment"
11237831|NCT02459197|OG001|Outcome|Placebo|"Heat Pain Stimuli B~Neutral Video~Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment"
11237832|NCT02459197|EG000|Reported Event|T4P1001|"Heat Pain Stimuli A~Positive Video~Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment"
11237833|NCT02459197|EG001|Reported Event|Placebo|"Heat Pain Stimuli B~Neutral Video~Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment"
11237834|NCT02459262|BG000|Baseline|Part A GBS-NN Vaccine 10mcg|GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237835|NCT02459262|BG001|Baseline|Part A GBS-NN Vaccine 50mcg|GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237836|NCT02459262|BG002|Baseline|Part A GBS-NN Vaccine 250mcg|GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237837|NCT02459262|BG003|Baseline|Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant|GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237838|NCT02459262|BG004|Baseline|Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant|GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237839|NCT02459262|BG005|Baseline|Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant|GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237840|NCT02459262|BG006|Baseline|Part A Placebo|Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
11237841|NCT02459262|BG007|Baseline|Part B GBS-NN Vaccine 50mcg|GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237842|NCT02459262|BG008|Baseline|Part B GBS-NN Vacine 100mcg 2 Dose Regimen|GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237843|NCT02459262|BG009|Baseline|Part B GBS-NN Vacine 100mcg Single Dose|GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
11237844|NCT02459262|BG010|Baseline|Part B Placebo|Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
11237845|NCT02459262|BG011|Baseline|Total|Total of all reporting groups
11237846|NCT02459262|FG000|Participant Flow|Part A GBS-NN Vaccine 10mcg|GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237847|NCT02459262|FG001|Participant Flow|Part A GBS-NN Vaccine 50mcg|GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237848|NCT02459262|FG002|Participant Flow|Part A GBS-NN Vaccine 250mcg|GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237849|NCT02459262|FG003|Participant Flow|Part A GBS-NN 10mcg Vaccine Administered With Alhydrogel® Adjuvant|GBS-NN 10mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237850|NCT02459262|FG004|Participant Flow|Part A GBS-NN 50mcg Vaccine Administered With Alhydrogel® Adjuvant|GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237851|NCT02459262|FG005|Participant Flow|Part A GBS-NN 250mcg Vaccine Administered With Alhydrogel® Adjuvant|GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237852|NCT02459262|FG006|Participant Flow|Part A Placebo|Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
11237853|NCT02459262|FG007|Participant Flow|Part B GBS-NN Vaccine 50mcg|GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237854|NCT02459262|FG008|Participant Flow|Part B GBS-NN Vaccine 100mcg 2 Dose Regimen|GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237855|NCT02459262|FG009|Participant Flow|Part B GBS-NN Vaccine 100mcg Single Dose|GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
11237856|NCT02459262|FG010|Participant Flow|Part B Placebo|Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
11237857|NCT02459262|OG000|Outcome|Part A GBS-NN Vaccine 10mcg|GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237858|NCT02459262|OG001|Outcome|Part A GBS-NN Vaccine 50mcg|GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237859|NCT02459262|OG002|Outcome|Part A GBS-NN Vaccine 250mcg|GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237860|NCT02459262|OG003|Outcome|Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant|GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11358938|NCT03348904|FG002|Participant Flow|Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy|"Nivolumab plus placebo in combination with platinum doublet chemotherapy included:~Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358939|NCT03348904|OG000|Outcome|Nivolumab + Epacadostat/Platinum Doublet Chemotherapy|"Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:~Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358940|NCT03348904|OG001|Outcome|Platinum Doublet Chemotherapy|"Platinum Doublet Chemotherapy included the following:~Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358941|NCT03348904|OG000|Outcome|Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy|"Nivolumab plus placebo in combination with platinum doublet chemotherapy included:~Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358942|NCT03348904|EG000|Reported Event|Nivolumab + Epacadostat/Platinum Doublet Chemotherapy|"Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:~Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358943|NCT03348904|EG001|Reported Event|Platinum Doublet Chemotherapy|"Platinum Doublet Chemotherapy included the following:~Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11358944|NCT03348904|EG002|Reported Event|Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy|"Nivolumab plus placebo in combination with platinum doublet chemotherapy included:~Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.~Optional continuation maintenance was available every 3 weeks, if eligible."
11376211|NCT01286272|EG000|Reported Event|Arm A (Ofatumumab, Bendamustine Hydrochloride)|"INDUCTION: Patients receive:~300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.~MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses."
10961916|NCT00863681|BG000|Baseline|Riociguat-Former Riociguat 1.0-2.5 mg|Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
11186365|NCT02100579|FG000|Participant Flow|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
11186366|NCT02100579|FG001|Participant Flow|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
11186367|NCT02100579|OG000|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
10961917|NCT00863681|BG001|Baseline|Riociguat-Former Placebo|Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
10961918|NCT00863681|BG002|Baseline|Riociguat-Former Riociguat 1.0-1.5 mg|Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
10961919|NCT00863681|BG003|Baseline|Total|Total of all reporting groups
10961920|NCT00863681|FG000|Participant Flow|Riociguat-Former Riociguat 1.0-2.5 mg|Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
10961921|NCT00863681|FG001|Participant Flow|Riociguat-Former Placebo|Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
10961922|NCT00863681|FG002|Participant Flow|Riociguat-Former Riociguat 1.0-1.5 mg|Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
10961923|NCT00863681|OG000|Outcome|Riociguat-Former Riociguat 1.0-2.5 mg|Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
10961924|NCT00863681|OG001|Outcome|Riociguat-Former Placebo|Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
11237861|NCT02459262|OG004|Outcome|Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant|GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237862|NCT02459262|OG005|Outcome|Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant|GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237863|NCT02459262|OG006|Outcome|Part A Placebo|Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
11237864|NCT02459262|OG000|Outcome|Part B GBS-NN Vaccine 50mcg|GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237865|NCT02459262|OG001|Outcome|Part B GBS-NN Vacine 100mcg 2 Dose Regimen|GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237866|NCT02459262|OG002|Outcome|Part B GBS-NN Vacine 100mcg Single Dose|GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
11237867|NCT02459262|OG003|Outcome|Part B Placebo|Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
11237868|NCT02459262|EG000|Reported Event|Part A GBS-NN Vaccine 10mcg|GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237869|NCT02459262|EG001|Reported Event|Part A GBS-NN Vaccine 50mcg|GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237870|NCT02459262|EG002|Reported Event|Part A GBS-NN Vaccine 250mcg|GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237871|NCT02459262|EG003|Reported Event|Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant|GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237872|NCT02459262|EG004|Reported Event|Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant|GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237873|NCT02459262|EG005|Reported Event|Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant|GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237874|NCT02459262|EG006|Reported Event|Part A Placebo|Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
11237875|NCT02459262|EG007|Reported Event|Part B GBS-NN Vaccine 50mcg|GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237876|NCT02459262|EG008|Reported Event|Part B GBS-NN Vacine 100mcg 2 Dose Regimen|GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
11237877|NCT02459262|EG009|Reported Event|Part B GBS-NN Vacine 100mcg Single Dose|GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
11237878|NCT02459262|EG010|Reported Event|Part B Placebo|Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
11237879|NCT02459275|BG000|Baseline|PEP uP Protocol|"Participants will receive the PEP uP protocol with the pro motility agent. The intervention will be provided until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.~PEP uP Protocol: Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.~Metoclopramide: Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked."
11237880|NCT02459275|BG001|Baseline|Standard of Care|Standard formula polymeric tube feeds started at a rate of 20 ml/hour. Gastric residual volume (GRV) will be checked every 4 hours. GRV is reinfused to the patient each time it is checked. GRV threshold is 200-500 ml. If the patient is tolerating tube feeds as determined by measuring the GRV, the rate is advanced by 20 ml/hour every 4 hours up to the goal rate. Participants will be followed until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.
10961925|NCT00863681|OG002|Outcome|Riociguat-Former Riociguat 1.0-1.5 mg|Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
10961926|NCT00863681|EG000|Reported Event|Former Riociguat 1.0- 2.5 mg|Patients from the PATENT-1 1.0 - 2.5 mg Dose Arm will enter the extension trial (PATENT-2)with the same dose which they have received on the last day of PATENT-1 (Visit 6).
10961927|NCT00863681|EG001|Reported Event|Former Riociguat 1.0 - 1.5 mg|Patients from the PATENT-1 1.0 - 1.5 mg Dose Arm will enter the extension trial (PATENT-2)with the same dose which they have received on the last day of PATENT-1 (Visit 6).
10961928|NCT00863681|EG002|Reported Event|Former Placebo|Patients from the PATENT-1 Placebo Arm will enter the extension trial (PATENT-2)with the starting dose 1 mg Riociguat tid.
11237881|NCT02459275|BG002|Baseline|Total|Total of all reporting groups
11186368|NCT02100579|OG001|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
11186369|NCT02100579|EG000|Reported Event|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
11186370|NCT02100579|EG001|Reported Event|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
11186371|NCT02100631|BG000|Baseline|PXVX0200 in Older Adults|PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.
11186372|NCT02100631|BG001|Baseline|Placebo in Older Adults|The placebo consisted of 100 mL of physiological saline administered orally. Physiological saline was sourced by the clinical sites. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.
11186373|NCT02100631|BG002|Baseline|Historical Control: Adults Aged 18-45|This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118
11186374|NCT02100631|BG003|Baseline|Total|Total of all reporting groups
11186375|NCT02100631|FG000|Participant Flow|PXVX0200 in Older Adults|PXVX0200 Single dose; liquid suspension after reconstitution with buffer; > 1x10^9 CFU in a liquid suspension
11186376|NCT02100631|FG001|Participant Flow|Placebo in Older Adults|Placebo physiological saline
11186377|NCT02100631|FG002|Participant Flow|Historical Control: Adults Aged 18-45|This arm consists of historical data from subjects who received a single dose of PXVX0200 in study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
11186378|NCT02100631|OG000|Outcome|PXVX0200 in Older Adults|PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.
11186379|NCT02100631|OG001|Outcome|Historical Control: Adults Aged 18-45|This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118
11186380|NCT02100631|OG002|Outcome|Placebo in Older Adults|Placebo physiological saline
11186381|NCT02100631|OG001|Outcome|Placebo in Older Adults|The placebo consisted of 100 mL of physiological saline administered orally. Physiological saline was sourced by the clinical sites. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.
11186382|NCT02100631|EG000|Reported Event|PXVX0200 in Older Adults|PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.
11186383|NCT02100631|EG001|Reported Event|Placebo in Older Adults|The placebo consisted of 100 mL of physiological saline administered orally. Physiological saline was sourced by the clinical sites. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.
11186384|NCT02100644|BG000|Baseline|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk
11186385|NCT02100644|FG000|Participant Flow|Escalation Phase: LTG Plus VPA|Participants received a fixed maintenance dose of VPA (400-1200 mg/d) along with lamotrigine (LTG) which was gradually escalated to 200 mg/d in accordance with the information of package insert: i.e. 25 mg of LTG was orally administered once every other day for the first 2 weeks and then once daily for the following 2 weeks. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 weeks for once or twice daily administration. If there were safety concerns, the LTG dose was decreased to 100 mg/d at the discretion of the investigator or sub-investigator. If there were still safety concerns despite the dose reduction to 100 mg/d, LTG was discontinued. The total duration of this phase was 8 to18 weeks.
11358945|NCT03345901|BG000|Baseline|Enrolled Participants|The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
11336598|NCT03569098|BG002|Baseline|Dysport 500 U|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336599|NCT03569098|BG003|Baseline|Total|Total of all reporting groups
11336600|NCT03569098|FG000|Participant Flow|Placebo|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of placebo (matching with Dysport) intramuscular injection distributed between 4 injection points in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
10961929|NCT00863707|BG000|Baseline|Placebo|Matching intravenous (IV) bolus injection
11336601|NCT03569098|FG001|Participant Flow|Dysport 300 U|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336602|NCT03569098|FG002|Participant Flow|Dysport 500 U|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336603|NCT03569098|OG000|Outcome|Placebo|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of placebo (matching with Dysport) intramuscular injection distributed between 4 injection points in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336604|NCT03569098|OG001|Outcome|Dysport 300 U|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336605|NCT03569098|OG002|Outcome|Dysport 500 U|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.~Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336606|NCT03569098|EG000|Reported Event|Double-Blind Treatment Period (Cycle 1): Placebo|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of placebo (matching with Dysport) intramuscular injection distributed between 4 injection points in the 4 targeted muscles of the study foot.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336607|NCT03569098|EG001|Reported Event|Double-Blind Treatment Period (Cycle 1): Dysport 300 U|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336608|NCT03569098|EG002|Reported Event|Double-Blind Treatment Period (Cycle 1): Dysport 500 U|"On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11337726|NCT03592745|OG000|Outcome|Active tVNS + Robotic Arm Therapy|"Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.~Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear."
11358946|NCT03345901|FG000|Participant Flow|Enrolled Participants|The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
11358947|NCT03345901|OG000|Outcome|Enrolled Participants|The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
11358948|NCT03345901|EG000|Reported Event|Pemafibrate|".2 mg pemafibrate orally BID~Pemafibrate: 0.2 mg orally BID - twice daily"
11358949|NCT03345901|EG001|Reported Event|Placebo|"Placebo pill orally BID~Placebo: orally BID - twice daily"
11358950|NCT03344562|BG000|Baseline|CES Active|"Active cranial electrical stimulation device~CES: Patients will receive cranial electrical stimulation once a day for 20 minutes over 7 days. They will be allowed to increase the stimulation level on Day 2. A wrist worn actigraph will record sleep. Patients may elect to receive standard of care sleep medication if not satisfied with sleep."
11358951|NCT03344562|BG001|Baseline|CES Sham|"Inactive device identical to the active device.~CES: Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days."
11358952|NCT03344562|BG002|Baseline|Total|Total of all reporting groups
11358953|NCT03344562|FG000|Participant Flow|CES Active|"Active cranial electrical stimulation device~CES: Patients will receive cranial electrical stimulation once a day for 20 minutes over 7 days. They will be allowed to increase the stimulation level on Day 2. A wrist worn actigraph will record sleep. Patients may elect to receive standard of care sleep medication if not satisfied with sleep."
11358954|NCT03344562|FG001|Participant Flow|CES Sham|"Inactive device identical to the active device.~CES: Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days."
11358955|NCT03344562|OG000|Outcome|CES Active|"Active cranial electrical stimulation device~CES: Patients will receive cranial electrical stimulation once a day for 20 minutes over 7 days. They will be allowed to increase the stimulation level on Day 2. A wrist worn actigraph will record sleep. Patients may elect to receive standard of care sleep medication if not satisfied with sleep."
11358956|NCT03344562|OG001|Outcome|CES Sham|"Inactive device identical to the active device.~CES: Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days."
11358957|NCT03344562|EG000|Reported Event|CES Active|"Active cranial electrical stimulation device~CES: Patients will receive cranial electrical stimulation once a day for 20 minutes over 7 days. They will be allowed to increase the stimulation level on Day 2. A wrist worn actigraph will record sleep. Patients may elect to receive standard of care sleep medication if not satisfied with sleep."
11358958|NCT03344562|EG001|Reported Event|CES Sham|"Inactive device identical to the active device.~CES: Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days."
11358959|NCT03342638|BG000|Baseline|Control Arm|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) will be administered post-transplant.~Cyclophosphamide: Potent immunosuppressive agent; an alkylating agent~Mesna: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis~rATG: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells~Methylprednisolone: Steroid~G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~Autologous Stem Cells: Infusion of participant's own stem cells"
11358960|NCT03342638|BG001|Baseline|IVIg Arm|"Hematopoietic Stem Cell Therapy performed as follows: Autologous stem cells will be infused after conditioning with cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. IVIg and G-CSF administered post-transplant.~Cyclophosphamide:immunosuppressive agent;alkylating agent~Mesna: Prophylaxis decrease for hemorrhagic cystitis~rATG: lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens found on the surface of T cells~Methylprednisolone: Steroid~G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes & stem cells and release them into the bloodstream~IVIg: Immunoglobulin G (IgG) products manufactured from pooled human plasma and typically contain more than 95% unmodified IgG, which has intact Fc-dependent effector functions and only trace amounts of immunoglobulin A (IgA) or immunoglobulin M (IgM).~Autologous Stem Cells: Infusion of one's own stem cells"
11358961|NCT03342638|BG002|Baseline|Total|Total of all reporting groups
10961930|NCT00863707|BG001|Baseline|Regadenoson|0.4 mg/5 mL intravenous bolus injection
10961931|NCT00863707|BG002|Baseline|Total|Total of all reporting groups
10961932|NCT00863707|FG000|Participant Flow|Placebo|Matching intravenous (IV) bolus injection
11358962|NCT03342638|FG000|Participant Flow|Control Arm|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) will be administered post-transplant.~Cyclophosphamide: Potent immunosuppressive agent; an alkylating agent~Mesna: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis~rATG: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells~Methylprednisolone: Steroid~G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~Autologous Stem Cells: Infusion of participant's own stem cells"
11358963|NCT03342638|FG001|Participant Flow|IVIg Arm|"Hematopoietic Stem Cell Therapy performed as follows: Autologous stem cells will be infused after conditioning with cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. IVIg and G-CSF administered post-transplant.~Cyclophosphamide:immunosuppressive agent;alkylating agent~Mesna: Prophylaxis decrease for hemorrhagic cystitis~rATG: lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens found on the surface of T cells~Methylprednisolone: Steroid~G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes & stem cells and release them into the bloodstream~IVIg: Immunoglobulin G (IgG) products manufactured from pooled human plasma and typically contain more than 95% unmodified IgG, which has intact Fc-dependent effector functions and only trace amounts of immunoglobulin A (IgA) or immunoglobulin M (IgM).~Autologous Stem Cells: Infusion of one's own stem cells"
11358964|NCT03342638|OG000|Outcome|Control Arm|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) will be administered post-transplant.~Cyclophosphamide: Potent immunosuppressive agent; an alkylating agent~Mesna: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis~rATG: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells~Methylprednisolone: Steroid~G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~Autologous Stem Cells: Infusion of participant's own stem cells"
11358965|NCT03342638|OG001|Outcome|IVIg Arm|"Hematopoietic Stem Cell Therapy performed as follows: Autologous stem cells will be infused after conditioning with cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. IVIg and G-CSF administered post-transplant.~Cyclophosphamide:immunosuppressive agent;alkylating agent~Mesna: Prophylaxis decrease for hemorrhagic cystitis~rATG: lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens found on the surface of T cells~Methylprednisolone: Steroid~G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes & stem cells and release them into the bloodstream~IVIg: Immunoglobulin G (IgG) products manufactured from pooled human plasma and typically contain more than 95% unmodified IgG, which has intact Fc-dependent effector functions and only trace amounts of immunoglobulin A (IgA) or immunoglobulin M (IgM).~Autologous Stem Cells: Infusion of one's own stem cells"
11358966|NCT03342638|EG000|Reported Event|Control Arm|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) will be administered post-transplant.~Cyclophosphamide: Potent immunosuppressive agent; an alkylating agent~Mesna: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis~rATG: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells~Methylprednisolone: Steroid~G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream~Autologous Stem Cells: Infusion of participant's own stem cells"
11358967|NCT03342638|EG001|Reported Event|IVIg Arm|"Hematopoietic Stem Cell Therapy performed as follows: Autologous stem cells will be infused after conditioning with cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. IVIg and G-CSF administered post-transplant.~Cyclophosphamide:immunosuppressive agent;alkylating agent~Mesna: Prophylaxis decrease for hemorrhagic cystitis~rATG: lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens found on the surface of T cells~Methylprednisolone: Steroid~G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes & stem cells and release them into the bloodstream~IVIg: Immunoglobulin G (IgG) products manufactured from pooled human plasma and typically contain more than 95% unmodified IgG, which has intact Fc-dependent effector functions and only trace amounts of immunoglobulin A (IgA) or immunoglobulin M (IgM).~Autologous Stem Cells: Infusion of one's own stem cells"
11358968|NCT03342157|BG000|Baseline|High-dose|"8.6/50 mg of senna/docusate, oral, twice daily~senna/docusate: Stimulant laxative"
11358969|NCT03342157|BG001|Baseline|Low-dose|"8.6/50 mg of senna/docusate, oral, once daily~senna/docusate: Stimulant laxative"
11358970|NCT03342157|BG002|Baseline|Total|Total of all reporting groups
11358971|NCT03342157|FG000|Participant Flow|High-dose|"8.6/50 mg of senna/docusate, oral, twice daily~senna/docusate: Stimulant laxative"
11358972|NCT03342157|FG001|Participant Flow|Low-dose|"8.6/50 mg of senna/docusate, oral, once daily~senna/docusate: Stimulant laxative"
11358973|NCT03342157|OG000|Outcome|High-dose|"8.6/50 mg of senna/docusate, oral, twice daily~senna/docusate: Stimulant laxative"
11358974|NCT03342157|OG001|Outcome|Low-dose|"8.6/50 mg of senna/docusate, oral, once daily~senna/docusate: Stimulant laxative"
11358975|NCT03342157|EG000|Reported Event|High-dose|"8.6/50 mg of senna/docusate, oral, twice daily~senna/docusate: Stimulant laxative"
11358976|NCT03342157|EG001|Reported Event|Low-dose|"8.6/50 mg of senna/docusate, oral, once daily~senna/docusate: Stimulant laxative"
11358977|NCT03339401|BG000|Baseline|Brincidofovir|"Brincidofovir (BCV) for the treatment of adenovirs (AdV) infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Brincidofovir (BCV) treatment began no later than 100 days post-transplant and was to continue for a maximum of 16 weeks. Brincidofovir (BCV) was discontinued once AdV viremia was confirmed undetectable.~Subjects who did NOT receive concurrent cyclosporine on Day 1:~If ≥48kg body weight, one 100mg oral tablet BIW (or 10mL of 10mg/mL oral suspension if unable to take tablets).~If <48kg body weight, 2mg/kg oral volume of 10mg/mL oral suspension BIW.~Subjects who received cyclosporine on Day 1 (or initiated cyclosporine at any time):~1.4mg/kg (maximum of 70mg) oral volume of 10mg/mL oral suspension BIW.~2mg/kg (maximum of 100mg) oral volume of 10mg/mL oral suspension BIW if discontinued cyclosporine."
11358978|NCT03339401|BG001|Baseline|Standard of Care|"Local institutional standard of care (SoC) (i.e., investigator-assigned therapy) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Management of these subjects was prescribed by the investigator as being in the best interests of the subject and may have included a watch-and-wait approach, with or without decreased immunosuppression (ergo, no treatment), or treatment administration with other available antivirals, most commonly cidofovir intravenously.~Decisions regarding SoC, including administration of therapy, dose and regimen of therapy, modification of immunosuppression, and monitoring was the responsibility of the clinical team caring for the subject, according to institutional guidelines, local practices, and applicable guidelines for the management of AdV infection."
11358979|NCT03339401|BG002|Baseline|Total|Total of all reporting groups
11358980|NCT03339401|FG000|Participant Flow|Brincidofovir|"Brincidofovir (BCV) for the treatment of adenovirs (AdV) infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Brincidofovir (BCV) treatment began no later than 100 days post-transplant and was to continue for a maximum of 16 weeks. Brincidofovir (BCV) was discontinued once AdV viremia was confirmed undetectable.~Subjects who did NOT receive concurrent cyclosporine on Day 1:~If ≥48kg body weight, one 100mg oral tablet BIW (or 10mL of 10mg/mL oral suspension if unable to take tablets).~If <48kg body weight, 2mg/kg oral volume of 10mg/mL oral suspension BIW.~Subjects who received cyclosporine on Day 1 (or initiated cyclosporine at any time):~1.4mg/kg (maximum of 70mg) oral volume of 10mg/mL oral suspension BIW.~2mg/kg (maximum of 100mg) oral volume of 10mg/mL oral suspension BIW if discontinued cyclosporine."
11358981|NCT03339401|FG001|Participant Flow|Standard of Care|"Local institutional standard of care (SoC) (i.e., investigator-assigned therapy) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Management of these subjects was prescribed by the investigator as being in the best interests of the subject and may have included a watch-and-wait approach, with or without decreased immunosuppression (ergo, no treatment), or treatment administration with other available antivirals, most commonly cidofovir intravenously.~Decisions regarding SoC, including administration of therapy, dose and regimen of therapy, modification of immunosuppression, and monitoring was the responsibility of the clinical team caring for the subject, according to institutional guidelines, local practices, and applicable guidelines for the management of AdV infection."
11358982|NCT03339401|OG000|Outcome|Brincidofovir|"Brincidofovir (BCV) for the treatment of adenovirs (AdV) infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Brincidofovir (BCV) treatment began no later than 100 days post-transplant and was to continue for a maximum of 16 weeks. Brincidofovir (BCV) was discontinued once AdV viremia was confirmed undetectable.~Subjects who did NOT receive concurrent cyclosporine on Day 1:~If ≥48kg body weight, one 100mg oral tablet BIW (or 10mL of 10mg/mL oral suspension if unable to take tablets).~If <48kg body weight, 2mg/kg oral volume of 10mg/mL oral suspension BIW.~Subjects who received cyclosporine on Day 1 (or initiated cyclosporine at any time):~1.4mg/kg (maximum of 70mg) oral volume of 10mg/mL oral suspension BIW.~2mg/kg (maximum of 100mg) oral volume of 10mg/mL oral suspension BIW if discontinued cyclosporine."
11358983|NCT03339401|OG001|Outcome|Standard of Care|"Local institutional standard of care (SoC) (i.e., investigator-assigned therapy) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Management of these subjects was prescribed by the investigator as being in the best interests of the subject and may have included a watch-and-wait approach, with or without decreased immunosuppression (ergo, no treatment), or treatment administration with other available antivirals, most commonly cidofovir intravenously.~Decisions regarding SoC, including administration of therapy, dose and regimen of therapy, modification of immunosuppression, and monitoring was the responsibility of the clinical team caring for the subject, according to institutional guidelines, local practices, and applicable guidelines for the management of AdV infection."
11358984|NCT03339401|EG000|Reported Event|Brincidofovir|"Brincidofovir (BCV) for the treatment of adenovirs (AdV) infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Brincidofovir (BCV) treatment began no later than 100 days post-transplant and was to continue for a maximum of 16 weeks. Brincidofovir (BCV) was discontinued once AdV viremia was confirmed undetectable.~Subjects who did NOT receive concurrent cyclosporine on Day 1:~If ≥48kg body weight, one 100mg oral tablet BIW (or 10mL of 10mg/mL oral suspension if unable to take tablets).~If <48kg body weight, 2mg/kg oral volume of 10mg/mL oral suspension BIW.~Subjects who received cyclosporine on Day 1 (or initiated cyclosporine at any time):~1.4mg/kg (maximum of 70mg) oral volume of 10mg/mL oral suspension BIW.~2mg/kg (maximum of 100mg) oral volume of 10mg/mL oral suspension BIW if discontinued cyclosporine."
11358985|NCT03339401|EG001|Reported Event|Standard of Care|"Local institutional standard of care (SoC) (i.e., investigator-assigned therapy) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Management of these subjects was prescribed by the investigator as being in the best interests of the subject and may have included a watch-and-wait approach, with or without decreased immunosuppression (ergo, no treatment), or treatment administration with other available antivirals, most commonly cidofovir intravenously.~Decisions regarding SoC, including administration of therapy, dose and regimen of therapy, modification of immunosuppression, and monitoring was the responsibility of the clinical team caring for the subject, according to institutional guidelines, local practices, and applicable guidelines for the management of AdV infection."
11358986|NCT03339245|BG000|Baseline|Glucose, Then Fructose|"Participants first receive Glucose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Fructose Solution (75 Grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.~Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.~Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner."
11358987|NCT03339245|BG001|Baseline|Fructose, Then Glucose|"Participants first receive Fructose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Glucose Solution (75 grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.~Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.~Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner."
11358988|NCT03339245|BG002|Baseline|Total|Total of all reporting groups
11358989|NCT03339245|FG000|Participant Flow|Fructose, Then Glucose|"Participants first receive Fructose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Glucose Solution (75 grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.~Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.~Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner."
10961933|NCT00863707|FG001|Participant Flow|Regadenoson|0.4 mg/5 mL intravenous bolus injection
10961934|NCT00863707|OG000|Outcome|Placebo|Matching intravenous (IV) bolus injection
11186386|NCT02100644|FG001|Participant Flow|Reduction Phase: LTG Plus VPA|Participants received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was determined at the discretion of the investigator or sub-investigator: e.g., 1000 mg/d (2 weeks), 800 mg/d (2 weeks), 600 mg/d (2 weeks), 400 mg/d (2 weeks), 300 mg/d OR 1000 mg/d (4 weeks), 600 mg/d (4 weeks), 300 mg/d and when VPA was reduced to less than 300 mg/d, the dose was reduced to 300, 200, 100, and 0 mg/d in 100 mg decrements in steps of at least one week duration. When VPA was concomitantly used, LTG was administered twice daily with 200 mg/d as a maintenance dose. If there were safety concerns during the LTG Escalation Phase, a fixed maintenance dose of 100 to 200 mg/d of LTG was administered twice daily. When VPA was withdrawn (that is, VPA was reduced to 0 mg/d), LTG was required to be increased by 50-100 mg/d. If there were any safety concern, 25 mg increment was also available. The total duration of this phase was 4 to16 weeks.
11186387|NCT02100644|FG002|Participant Flow|Maintenance Phase: LTG Plus VPA|Participants received two different treatments. In one group, participants received a fixed maintenance dose of LTG 200 mg/d (or 100 to 200 mg/d if there were safety concerns during the LTG Escalation Phase) and VPA 100 mg/d (or higher if seizures occurred during the VPA Reduction Phase) were administered twice and 1-3 times daily, respectively, for 12 weeks. The frequency of administration was not changed. If seizures occurred, VPA dose could be increased/re-introduced. On the other group, after VPA was withdrawn, LTG dose was escalated up to 300 mg/d with 50-100 mg increment per 1-2 weeks. If there was safety concern or if remaining dose to 300 mg/d was below 50 mg, 25 mg increment was also available. If seizures occurred, LTG dose was increased up to 400 mg/d. If there was safety concern, LTG dose was decreased to 100 mg/d. If there was still safety concern at 100 mg/d, the participants were discontinued from the study. The total duration of this phase was 12 weeks.
11186388|NCT02100644|OG000|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
11186389|NCT02100644|EG000|Reported Event|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to &lt; 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
11186390|NCT02100657|BG000|Baseline|Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)|Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186391|NCT02100657|BG001|Baseline|Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)|Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186392|NCT02100657|BG002|Baseline|Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)|Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186393|NCT02100657|BG003|Baseline|Total|Total of all reporting groups
11186394|NCT02100657|FG000|Participant Flow|Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)|Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186395|NCT02100657|FG001|Participant Flow|Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)|Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186396|NCT02100657|FG002|Participant Flow|Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)|Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186397|NCT02100657|OG000|Outcome|All Participants|All participants who received at least 1 dose of plitidepsin as a 3-hour i.v. infusion on Days 1 and 15 in combination with BTZ administered s.c. on Days 1, 4, 8 and 11, and DXM orally on Days 1, 8, 15 and 22 q4wk in patients with relapsed and/or refractory MM
11186398|NCT02100657|OG000|Outcome|Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)|Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
10961935|NCT00863707|OG001|Outcome|Regadenoson|0.4 mg/5 mL intravenous bolus injection
10961936|NCT00863707|EG000|Reported Event|Placebo|Matching intravenous (IV) bolus injection
11237882|NCT02459275|FG000|Participant Flow|PEP uP Protocol|"Participants will receive the PEP uP protocol with the pro motility agent. The intervention will be provided until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.~PEP uP Protocol: Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.~Metoclopramide: Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked."
11237883|NCT02459275|FG001|Participant Flow|Standard of Care|Standard formula polymeric tube feeds started at a rate of 20 ml/hour. Gastric residual volume (GRV) will be checked every 4 hours. GRV is reinfused to the patient each time it is checked. GRV threshold is 200-500 ml. If the patient is tolerating tube feeds as determined by measuring the GRV, the rate is advanced by 20 ml/hour every 4 hours up to the goal rate. Participants will be followed until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.
11237884|NCT02459275|OG000|Outcome|PEP uP Protocol|"Participants will receive the PEP uP protocol with the pro motility agent. The intervention will be provided until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.~PEP uP Protocol: Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.~Metoclopramide: Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked."
11237885|NCT02459275|OG001|Outcome|Standard of Care|Standard formula polymeric tube feeds started at a rate of 20 ml/hour. Gastric residual volume (GRV) will be checked every 4 hours. GRV is reinfused to the patient each time it is checked. GRV threshold is 200-500 ml. If the patient is tolerating tube feeds as determined by measuring the GRV, the rate is advanced by 20 ml/hour every 4 hours up to the goal rate. Participants will be followed until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.
11237886|NCT02459275|EG000|Reported Event|PEP uP Protocol|"Participants will receive the PEP uP protocol with the pro motility agent. The intervention will be provided until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.~PEP uP Protocol: Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.~Metoclopramide: Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked."
11237887|NCT02459275|EG001|Reported Event|Standard of Care|Standard formula polymeric tube feeds started at a rate of 20 ml/hour. Gastric residual volume (GRV) will be checked every 4 hours. GRV is reinfused to the patient each time it is checked. GRV threshold is 200-500 ml. If the patient is tolerating tube feeds as determined by measuring the GRV, the rate is advanced by 20 ml/hour every 4 hours up to the goal rate. Participants will be followed until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.
11237888|NCT02459418|BG000|Baseline|AFOLIA Then Gonal-f® RFF|"On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.~Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 International Units (IU) AFOLIA, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.~Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation, 225 IU Gonal-f® RFF on study day 27.~Exit examinations were performed on study day 35."
11237889|NCT02459418|BG001|Baseline|Gonal-f® RFF Then AFOLIA|"On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.~Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 IU Gonal-f® RFF, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.~Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation of 225 IU AFOLIA on study day 27.~Exit examinations were performed on study day 35."
11237890|NCT02459418|BG002|Baseline|Total|Total of all reporting groups
11237891|NCT02459418|FG000|Participant Flow|AFOLIA Then Gonal-f® RFF|"On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.~Period 1: On study day 1, eligible subjects received a single subcutaneous (s.c.) dose of the first FSH preparation, 225 International Units (IU) AFOLIA, in the abdomen. On study day 16, subjects received a second LupronDepot® intramuscular (i.m.) injection.~Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation, 225 IU Gonal-f® RFF, on study day 27. Exit examinations were performed on study day 35."
10961937|NCT00863707|EG001|Reported Event|Regadenoson|0.4 mg/5 mL intravenous bolus injection
11358990|NCT03339245|FG001|Participant Flow|Glucose, Then Fructose|"Participants first receive Glucose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Fructose Solution (75 Grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.~Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.~Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner."
11358991|NCT03339245|OG000|Outcome|Fructose, Then Glucose|"Participants first receive Fructose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Glucose Solution (75 grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.~Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.~Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner."
11358992|NCT03339245|OG001|Outcome|Glucose, Then Fructose|"Participants first receive Glucose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Fructose Solution (75 Grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.~Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.~Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner."
11358993|NCT03339245|EG000|Reported Event|Fructose, Then Glucose|"Participants first receive Fructose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Glucose Solution (75 grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.~Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.~Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner."
11358994|NCT03339245|EG001|Reported Event|Glucose, Then Fructose|"Participants first receive Glucose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Fructose Solution (75 Grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.~Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.~Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner."
11358995|NCT03333746|BG000|Baseline|Treatment (Lenalidomide, Nivolumab)|"Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO~Nivolumab: Given IV~Pharmacological Study: Correlative studies"
11358996|NCT03333746|FG000|Participant Flow|Treatment (Lenalidomide, Nivolumab)|"Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO~Nivolumab: Given IV~Pharmacological Study: Correlative studies"
11358997|NCT03333746|OG000|Outcome|Treatment (Lenalidomide, Nivolumab)|"Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO~Nivolumab: Given IV~Pharmacological Study: Correlative studies"
11358998|NCT03333746|EG000|Reported Event|Treatment (Lenalidomide, Nivolumab)|"Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO~Nivolumab: Given IV~Pharmacological Study: Correlative studies"
11358999|NCT03329404|BG000|Baseline|Mirasol Red Blood Cells (MIR RBCs)/Reference Red Blood Cells (REF RBCs) Treatment Sequence|"MIR RBCs: RBCs were derived from whole blood (WB) collected in citrate phosphate dextrose (CPD) solution, treated with the Mirasol System for WB, Leukoreduced (LR), and stored in Additive Solution Formula 3 (AS-3) for ≤ 21 days at 1 - 6°C.~REF RBCs: LR apheresis RBCs or WB-derived RBCs were per site standard inventory."
11359000|NCT03329404|BG001|Baseline|Reference Red Blood Cells (REF RBCs)/Mirasol Red Blood Cells (MIR RBCs) Treatment Sequence|"REF RBCs: Leukoreduced (LR) apheresis RBCs or whole blood (WB)-derived RBCs were per site standard inventory.~MIR RBCs: RBCs were derived from WB collected in citrate phosphate dextrose (CPD) solution, treated with the Mirasol System for WB, LR, and stored in Additive Solution Formula 3 (AS-3) for ≤ 21 days at 1 - 6°C."
11359001|NCT03329404|BG002|Baseline|Total|Total of all reporting groups
11359002|NCT03329404|FG000|Participant Flow|Mirasol Red Blood Cells (MIR RBCs) Followed by Reference RBCs (REF RBCs)|"MIR RBCs: RBCs were derived from whole blood (WB) collected in citrate phosphate dextrose (CPD) solution, treated with the Mirasol System for WB, Leukoreduced (LR), and stored in Additive Solution Formula 3 (AS-3) for ≤ 21 days at 1 - 6°C.~REF RBCs: LR apheresis RBCs or WB-derived RBCs were per site standard inventory."
11359003|NCT03329404|FG001|Participant Flow|Reference Red Blood Cells (REF RBCs) Followed by Mirasol RBCs (MIR RBCs)|"REF RBCs: Leukoreduced (LR) apheresis RBCs or whole blood (WB)-derived RBCs were per site standard inventory.~MIR RBCs: RBCs were derived from WB collected in citrate phosphate dextrose (CPD) solution, treated with the Mirasol System for WB, LR, and stored in Additive Solution Formula 3 (AS-3) for ≤ 21 days at 1 - 6°C."
11186399|NCT02100657|OG001|Outcome|Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)|Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186400|NCT02100657|OG002|Outcome|Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)|Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11359004|NCT03329404|OG000|Outcome|Mirasol Red Blood Cells (MIR RBCs)|"MIR RBCs: RBCs were derived from whole blood (WB) collected in citrate phosphate dextrose (CPD) solution, treated with the Mirasol System for WB, Leukoreduced (LR), and stored in Additive Solution Formula 3 (AS-3) for ≤ 21 days at 1 - 6°C.~REF RBCs: LR apheresis RBCs or WB-derived RBCs were per site standard inventory."
11186401|NCT02100657|EG000|Reported Event|Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)|Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186402|NCT02100657|EG001|Reported Event|Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)|Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186403|NCT02100657|EG002|Reported Event|Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)|Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
11186404|NCT02100670|BG000|Baseline|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium with 3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186405|NCT02100670|BG001|Baseline|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186406|NCT02100670|BG002|Baseline|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186407|NCT02100670|BG003|Baseline|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186408|NCT02100670|BG004|Baseline|Total|Total of all reporting groups
11186409|NCT02100670|FG000|Participant Flow|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium with 3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11359005|NCT03329404|OG001|Outcome|Reference Red Blood Cells (REF RBCs)|"REF RBCs: Leukoreduced (LR) apheresis RBCs or whole blood (WB)-derived RBCs will be per site standard inventory.~MIR RBCs: RBCs will be derived from WB collected in citrate phosphate dextrose (CPD) solution, treated with the Mirasol System for WB, LR, and stored in Additive Solution Formula 3 (AS-3) for ≤ 21 days at 1 - 6°C."
11186410|NCT02100670|FG001|Participant Flow|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186411|NCT02100670|FG002|Participant Flow|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186412|NCT02100670|FG003|Participant Flow|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186413|NCT02100670|OG000|Outcome|1% Diclofenac Sodium Plus (+) 3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186414|NCT02100670|OG001|Outcome|Placebo|Placebo gel was supplied in 30g tubes for each participant to apply 4g of gel topically to the injured ankle region four times daily for up to 10 days.
11186415|NCT02100670|OG000|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186416|NCT02100670|OG001|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186417|NCT02100670|OG002|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186418|NCT02100670|OG003|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186419|NCT02100670|OG002|Outcome|3% Menthol|3% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186420|NCT02100670|OG000|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participants to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186421|NCT02100670|OG001|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participants to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186422|NCT02100670|OG002|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participants to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186423|NCT02100670|OG003|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participants to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186424|NCT02100670|EG000|Reported Event|1% Diclofenac Sodium Plus 3% Menthol|1% diclofenac sodium plus 3% menthol gel supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186425|NCT02100670|EG001|Reported Event|1% Diclofenac Sodium Plus 0.09% Menthol|1% diclofenac sodium plus 0.09% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186426|NCT02100670|EG002|Reported Event|3% Menthol|3% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186427|NCT02100670|EG003|Reported Event|Placebo With 0.09% Menthol Gel|Placebo with 0.09% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
11186428|NCT02100696|BG000|Baseline|Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase)|Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.
11186429|NCT02100696|BG001|Baseline|Cohort 2: Placebo (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.
11186430|NCT02100696|BG002|Baseline|Cohort 2: Etrolizumab (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.
11186431|NCT02100696|BG003|Baseline|Placebo Responders: Placebo (Maintenance Phase)|Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.
11186432|NCT02100696|BG004|Baseline|Etrolizumab Responders: Placebo (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.
11186433|NCT02100696|BG005|Baseline|Etrolizumab Responders: Etrolizumab (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.
11186434|NCT02100696|BG006|Baseline|Total|Total of all reporting groups
11186435|NCT02100696|FG000|Participant Flow|Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase)|Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.
11186436|NCT02100696|FG001|Participant Flow|Cohort 2: Placebo (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.
11186437|NCT02100696|FG002|Participant Flow|Cohort 2: Etrolizumab (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.
11186438|NCT02100696|FG003|Participant Flow|Placebo Responders: Placebo (Maintenance Phase)|Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.
11186439|NCT02100696|FG004|Participant Flow|Etrolizumab Responders: Placebo (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.
11186440|NCT02100696|FG005|Participant Flow|Etrolizumab Responders: Etrolizumab (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.
11186441|NCT02100696|OG000|Outcome|Cohort 2: Placebo (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.
11186442|NCT02100696|OG001|Outcome|Cohort 2: Etrolizumab (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.
11186443|NCT02100696|OG000|Outcome|Etrolizumab Responders: Placebo (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.
11186444|NCT02100696|OG001|Outcome|Etrolizumab Responders: Etrolizumab (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.
11186445|NCT02100696|OG000|Outcome|Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase)|Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.
11186446|NCT02100696|OG001|Outcome|Cohort 2: Placebo (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.
11186447|NCT02100696|OG002|Outcome|Cohort 2: Etrolizumab (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.
11186448|NCT02100696|OG003|Outcome|Placebo Responders: Placebo (Maintenance Phase)|Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.
11359006|NCT03329404|EG000|Reported Event|Mirasol Red Blood Cells (MIR RBCs)|MIR RBCs: RBCs were derived from whole blood (WB) collected in citrate phosphate dextrose (CPD) solution, treated with the Mirasol System for WB, leukoreduced, and stored in Additive Solution Formula 3 (AS-3) for ≤ 21 days at 1 - 6°C.
11359007|NCT03329404|EG001|Reported Event|Reference Red Blood Cells (REF RBCs)|REF RBCs: Leukoreduced apheresis RBCs or whole blood-derived RBCs were per site standard inventory.
11359008|NCT03326869|BG000|Baseline|Delayed|"Intervention: Raindrop Near Vision Inlay~In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.~Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems."
11359009|NCT03326869|BG001|Baseline|Non-Delayed|"Intervention: Raindrop Near Vision Inlay~In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day.~Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems."
11359010|NCT03326869|BG002|Baseline|Total|Total of all reporting groups
11359011|NCT03326869|FG000|Participant Flow|Delayed|"Intervention: Raindrop Near Vision Inlay~In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.~Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems."
11359012|NCT03326869|FG001|Participant Flow|Non-Delayed|"Intervention: Raindrop Near Vision Inlay~In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day.~Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems."
11359013|NCT03326869|OG000|Outcome|Delayed|"Intervention: Raindrop Near Vision Inlay~In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.~Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems."
11359014|NCT03326869|OG001|Outcome|Non-Delayed|"Intervention: Raindrop Near Vision Inlay~In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day.~Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems."
11359015|NCT03326869|EG000|Reported Event|Delayed|"Intervention: Raindrop Near Vision Inlay~In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.~Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems."
11359016|NCT03326869|EG001|Reported Event|Non-Delayed|"Intervention: Raindrop Near Vision Inlay~In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day.~Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems."
11359017|NCT03325114|BG000|Baseline|Chlorthalidone|"Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks~Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks"
11359018|NCT03325114|FG000|Participant Flow|Chlorthalidone|"Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks~Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks"
11359019|NCT03325114|OG000|Outcome|Chlorthalidone|"Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks~Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks"
11359020|NCT03325114|EG000|Reported Event|Chlorthalidone|"Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks~Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks"
11359021|NCT03319407|BG000|Baseline|Observation|"All participants will be monitored with EPAD system~EPAD monitoring system: EPAD system will be used as part of routine care"
11359022|NCT03319407|FG000|Participant Flow|Observation|"All participants will be monitored with EPAD system~EPAD monitoring system: EPAD system will be used as part of routine care"
11359023|NCT03319407|OG000|Outcome|Observation|"All participants will be monitored with EPAD system~EPAD monitoring system: EPAD system will be used as part of routine care"
11359024|NCT03319407|EG000|Reported Event|Observation|"All participants will be monitored with EPAD system~EPAD monitoring system: EPAD system will be used as part of routine care"
10961938|NCT00863746|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
11359025|NCT03316105|BG000|Baseline|TENS Unit Stimulation|"During this TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will take pressure readings after being placed. After four hours, subjects will again be given a second meal. Fifteen minutes of electrical stimulation will be given to subjects fifteen minutes before ingestion of lunch. After ingestion of lunch, 60 minutes of the electrical stimulation will be applied. When the test is done, the tube will be removed.~Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area."
11359026|NCT03316105|BG001|Baseline|No TENS Unit Stimulation|"During this no TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will record stomach pressure readings after being placed. After four hours, subjects will again be given a second meal. The TENS unit stimulation will be placed but no electrical stimulation will be given. When the test is done, the tube will be removed.~Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area."
11359027|NCT03316105|BG002|Baseline|Total|Total of all reporting groups
11359028|NCT03316105|FG000|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS) Stimulation|"During this TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will take pressure readings after being placed. After four hours, subjects will again be given a second meal. Fifteen minutes of electrical stimulation will be given to subjects fifteen minutes before ingestion of lunch. After ingestion of lunch, 60 minutes of the electrical stimulation will be applied. When the test is done, the tube will be removed.~Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area."
11359029|NCT03316105|FG001|Participant Flow|No TENS Stimulation|"During this no TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will record stomach pressure readings after being placed. After four hours, subjects will again be given a second meal. The TENS unit stimulation will be placed but no electrical stimulation will be given. When the test is done, the tube will be removed.~Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area."
11359030|NCT03316105|OG000|Outcome|TENS Unit Stimulation|"During this TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will take pressure readings after being placed. After four hours, subjects will again be given a second meal. Fifteen minutes of electrical stimulation will be given to subjects fifteen minutes before ingestion of lunch. After ingestion of lunch, 60 minutes of the electrical stimulation will be applied. When the test is done, the tube will be removed.~Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area."
11359031|NCT03316105|OG001|Outcome|No TENS Unit Stimulation|"During this no TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will record stomach pressure readings after being placed. After four hours, subjects will again be given a second meal. The TENS unit stimulation will be placed but no electrical stimulation will be given. When the test is done, the tube will be removed.~Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area."
11359032|NCT03316105|EG000|Reported Event|TENS Unit Stimulation|"During this TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will take pressure readings after being placed. After four hours, subjects will again be given a second meal. Fifteen minutes of electrical stimulation will be given to subjects fifteen minutes before ingestion of lunch. After ingestion of lunch, 60 minutes of the electrical stimulation will be applied. When the test is done, the tube will be removed.~Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area."
11359033|NCT03316105|EG001|Reported Event|No TENS Unit Stimulation|"During this no TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will record stomach pressure readings after being placed. After four hours, subjects will again be given a second meal. The TENS unit stimulation will be placed but no electrical stimulation will be given. When the test is done, the tube will be removed.~Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area."
10961939|NCT00863746|BG001|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
11359034|NCT03305055|BG000|Baseline|Fentanyl Plus Ketamine|"Study drug group~Ketamine Loading Dose (Low Dose, Slow Infusion) =~• 0.3 mg/kg; Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, … Then,~Fentanyl Loading Dose (UC, injection) =~• 1 mcg / kg. This is given to participants in both Group 1 and Group 2 initiated < 1 minute prior to wound care.~Ketamine (Study Drug, Infusion) = • 2.5 mcg/kg/min, Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.~Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication.~ketamine: Information included in arm descriptions~Fentanyl: Information included in arm descriptions"
11359035|NCT03305055|BG001|Baseline|Fentanyl Plus Saline|"Usual care group~Saline Loading Dose (Low Dose, Slow Infusion) =~• An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), … Then, ...~Fentanyl Loading Dose (UC, injection) =~• 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated <1 minute prior to wound care.~Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.~FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication.~Fentanyl: Information included in arm descriptions"
11359036|NCT03305055|BG002|Baseline|Total|Total of all reporting groups
11359037|NCT03305055|FG000|Participant Flow|Fentanyl Plus Ketamine|"Study drug group~Ketamine Loading Dose (Low Dose, Slow Infusion) =~• 0.3 mg/kg; Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, … Then,~Fentanyl Loading Dose (UC, injection) =~• 1 mcg / kg. This is given to participants in both Group 1 and Group 2 initiated < 1 minute prior to wound care.~Ketamine (Study Drug, Infusion) = • 2.5 mcg/kg/min, Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.~Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication.~ketamine: Information included in arm descriptions~Fentanyl: Information included in arm descriptions"
11359038|NCT03305055|FG001|Participant Flow|Fentanyl Plus Saline|"Usual care group~Saline Loading Dose (Low Dose, Slow Infusion) =~• An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), … Then, ...~Fentanyl Loading Dose (UC, injection) =~• 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated <1 minute prior to wound care.~Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.~FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication.~Fentanyl: Information included in arm descriptions"
11359039|NCT03305055|OG000|Outcome|Fentanyl Plus Ketamine|"Study drug group~Ketamine Loading Dose (Low Dose, Slow Infusion) =~• 0.3 mg/kg; Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, … Then,~Fentanyl Loading Dose (UC, injection) =~• 1 mcg / kg. This is given to participants in both Group 1 and Group 2 initiated < 1 minute prior to wound care.~Ketamine (Study Drug, Infusion) = • 2.5 mcg/kg/min, Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.~Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication.~ketamine: Information included in arm descriptions~Fentanyl: Information included in arm descriptions"
11359040|NCT03305055|OG001|Outcome|Fentanyl Plus Saline|"Usual care group~Saline Loading Dose (Low Dose, Slow Infusion) =~• An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), … Then, ...~Fentanyl Loading Dose (UC, injection) =~• 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated <1 minute prior to wound care.~Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.~FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication.~Fentanyl: Information included in arm descriptions"
11359041|NCT03305055|EG000|Reported Event|Fentanyl Plus Ketamine|"Study drug group~Ketamine Loading Dose (Low Dose, Slow Infusion) =~• 0.3 mg/kg; Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, … Then,~Fentanyl Loading Dose (UC, injection) =~• 1 mcg / kg. This is given to participants in both Group 1 and Group 2 initiated < 1 minute prior to wound care.~Ketamine (Study Drug, Infusion) = • 2.5 mcg/kg/min, Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.~Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication.~ketamine: Information included in arm descriptions~Fentanyl: Information included in arm descriptions"
11359042|NCT03305055|EG001|Reported Event|Fentanyl Plus Saline|"Usual care group~Saline Loading Dose (Low Dose, Slow Infusion) =~• An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), … Then, ...~Fentanyl Loading Dose (UC, injection) =~• 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated <1 minute prior to wound care.~Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.~FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication.~Fentanyl: Information included in arm descriptions"
10961940|NCT00863746|BG002|Baseline|Total|Total of all reporting groups
10961941|NCT00863746|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
11359043|NCT03303469|BG000|Baseline|FMISO PET Imaging Post TACE and SBRT|"FMISO imaging at baseline, post-TACE and post-SBRT~FMISO: FMISO PET/CT imaging at baseline~FMISO: FMISO PET/CT post TACE~FMISO: FMISO PET/CT post SBRT"
11359044|NCT03303469|FG000|Participant Flow|FMISO PET Imaging Post TACE and SBRT|"FMISO imaging at baseline, post-TACE and post-SBRT~FMISO: FMISO PET/CT imaging at baseline~FMISO: FMISO PET/CT post TACE~FMISO: FMISO PET/CT post SBRT"
11359045|NCT03303469|OG000|Outcome|FMISO PET Imaging Post TACE and SBRT|"FMISO imaging at baseline, post-TACE and post-SBRT~FMISO: FMISO PET/CT imaging at baseline~FMISO: FMISO PET/CT post TACE~FMISO: FMISO PET/CT post SBRT"
11359046|NCT03303469|EG000|Reported Event|FMISO PET Imaging Post TACE and SBRT|"FMISO imaging at baseline, post-TACE and post-SBRT~FMISO: FMISO PET/CT imaging at baseline~FMISO: FMISO PET/CT post TACE~FMISO: FMISO PET/CT post SBRT"
11359047|NCT03302247|BG000|Baseline|Nivolumab+Gemcitabine|"Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle~Nivolumab: Monoclonal antibody against non small cell lung cancer~Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment"
11359048|NCT03302247|FG000|Participant Flow|Nivolumab+Gemcitabine|"Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle~Nivolumab: Monoclonal antibody against non small cell lung cancer~Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment"
11359049|NCT03302247|OG000|Outcome|Nivolumab+Gemcitabine|"Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle~Nivolumab: Monoclonal antibody against non small cell lung cancer~Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment"
11359050|NCT03302247|EG000|Reported Event|Nivolumab+Gemcitabine|"Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle~Nivolumab: Monoclonal antibody against non small cell lung cancer~Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment"
11359051|NCT03300024|BG000|Baseline|Expanded Polytetrafluoroethylene (ePTFE)|"The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion.~Expanded polytetrafluoroethylene Graft: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery t"
11359052|NCT03300024|BG001|Baseline|Bovine Carotid Artery Graft|"The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.~Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case."
11359053|NCT03300024|BG002|Baseline|Total|Total of all reporting groups
11186449|NCT02100696|OG004|Outcome|Etrolizumab Responders: Placebo (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.
11359054|NCT03300024|FG000|Participant Flow|Expanded Polytetrafluoroethylene (ePTFE)|"The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion.~Expanded polytetrafluoroethylene Graft: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery t"
11359055|NCT03300024|FG001|Participant Flow|Bovine Carotid Artery Graft|"The bovine carotid artery (BCA) biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.~Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case."
11359056|NCT03300024|OG000|Outcome|Bovine Carotid Artery Graft|"The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.~Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case."
11359057|NCT03300024|OG001|Outcome|Expanded Polytetrafluoroethylene (ePTFE)|The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.
11359058|NCT03300024|OG000|Outcome|Expanded Polytetrafluoroethylene (ePTFE)|The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.
11359059|NCT03300024|OG001|Outcome|Bovine Carotid Artery Graft|"The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.~Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case."
11359060|NCT03300024|EG000|Reported Event|Expanded Polytetrafluoroethylene (ePTFE)|The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.
11359061|NCT03300024|EG001|Reported Event|Bovine Carotid Artery Graft|"The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.~Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case."
11359062|NCT03283709|BG000|Baseline|Full-contour Monolithic Zirconia Crowns|"If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia~Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia"
11359063|NCT03283709|BG001|Baseline|Conventional Abutment Crowns|"If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain~Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain"
11359064|NCT03283709|BG002|Baseline|Total|Total of all reporting groups
11359065|NCT03283709|FG000|Participant Flow|Full-contour Monolithic Zirconia Crowns|"If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia~Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia"
11359066|NCT03283709|FG001|Participant Flow|Conventional Abutment Crowns|"If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain~Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain"
11359067|NCT03283709|OG000|Outcome|Full-contour Monolithic Zirconia Crowns|"If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia~Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia"
11359068|NCT03283709|OG001|Outcome|Conventional Abutment Crowns|"If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain~Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain"
11359069|NCT03283709|EG000|Reported Event|Full-contour Monolithic Zirconia Crowns|"If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia~Full-contour monolithic zirconia abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia"
11359070|NCT03283709|EG001|Reported Event|Conventional Abutment Crowns|"If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain~Conventional abutment crowns: Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain"
11359071|NCT03277183|BG000|Baseline|Low Dose Erythropoietin|"Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly~Low dose erythropoietin: Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly"
11359072|NCT03277183|BG001|Baseline|High Dose Erythropoietin|"Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks~High dose erythropoietin: Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks"
11359073|NCT03277183|BG002|Baseline|Total|Total of all reporting groups
11359074|NCT03277183|FG000|Participant Flow|Low Dose Erythropoietin|"Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly~Low dose erythropoietin: Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly"
11359075|NCT03277183|FG001|Participant Flow|High Dose Erythropoietin|"Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks~High dose erythropoietin: Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks"
11359076|NCT03277183|OG000|Outcome|Low Dose Erythropoietin|"Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly~Low dose erythropoietin: Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly"
11359077|NCT03277183|OG001|Outcome|High Dose Erythropoietin|"Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks~High dose erythropoietin: Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks"
11186450|NCT02100696|OG005|Outcome|Etrolizumab Responders: Etrolizumab (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.
11186451|NCT02100696|OG000|Outcome|Cohort 1: Etrolizumab (OLI Phase) + Cohort 2: Etrolizumab (Double-Blind Induction Phase)|"Cohort 1: Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.~Cohort 2: Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase. Participants in this arm did not enter into the Maintenance phase of the study."
11186452|NCT02100696|OG001|Outcome|Etrolizumab Responders: Placebo (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.
11186453|NCT02100696|OG002|Outcome|Etrolizumab Responders: Etrolizumab (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.
11186454|NCT02100696|EG000|Reported Event|Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase)|Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.
11186455|NCT02100696|EG001|Reported Event|Cohort 2: Placebo (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.
11186456|NCT02100696|EG002|Reported Event|Cohort 2: Etrolizumab (Double-Blind Induction Phase)|Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.
11186457|NCT02100696|EG003|Reported Event|Placebo Responders: Placebo (Maintenance Phase)|Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.
11186458|NCT02100696|EG004|Reported Event|Etrolizumab Responders: Placebo (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.
11186459|NCT02100696|EG005|Reported Event|Etrolizumab Responders: Etrolizumab (Maintenance Phase)|Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.
11186460|NCT02100748|BG000|Baseline|Part A - TRV130 1 mg|"TRV130 1 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186461|NCT02100748|BG001|Baseline|Part A - TRV130 2 mg|"TRV130 2 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186462|NCT02100748|BG002|Baseline|Part A - TRV130 3 mg|"TRV130 3 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186463|NCT02100748|BG003|Baseline|Part A - TRV130 4 mg|"TRV130 4 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186464|NCT02100748|BG004|Baseline|Part A - Morphine|"Morphine 4 mg IV Q4H x 48 h~Morphine: Morphine 4 mg will be administered every 4 hours"
11186465|NCT02100748|BG005|Baseline|Part A - Placebo|"Placebo (D5W) IV Q4H x 48 h~Placebo: Placebo will be administered every 4 hours"
11186466|NCT02100748|BG006|Baseline|Part B - TRV130 0.5 mg|"TRV130 0.5 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186467|NCT02100748|BG007|Baseline|Part B - TRV130 1 mg|"TRV130 1 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186468|NCT02100748|BG008|Baseline|Part B - TRV130 2 mg|"TRV130 2 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186469|NCT02100748|BG009|Baseline|Part B - TRV130 3 mg|"TRV130 3 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186470|NCT02100748|BG010|Baseline|Part B - Placebo|"Placebo (D5W) IV Q3H x 48 h~Placebo: Placebo will be administered every 3 hours"
11186471|NCT02100748|BG011|Baseline|Part B - Morphine|"Morphine 4 mg IV Q4H x 48 h~Morphine: Morphine 4 mg will be administered every 4 hours"
11186472|NCT02100748|BG012|Baseline|Total|Total of all reporting groups
11186473|NCT02100748|FG000|Participant Flow|Part A - TRV130 1 mg|"TRV130 1 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
10961942|NCT00863746|FG001|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
11186474|NCT02100748|FG001|Participant Flow|Part A - TRV130 2 mg|"TRV130 2 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186475|NCT02100748|FG002|Participant Flow|Part A - TRV130 3 mg|"TRV130 3 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186476|NCT02100748|FG003|Participant Flow|Part A - TRV130 4 mg|"TRV130 4 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186477|NCT02100748|FG004|Participant Flow|Part A - Morphine|"Morphine 4 mg IV Q4H x 48 h~Morphine: Morphine 4 mg will be administered every 4 hours"
11186478|NCT02100748|FG005|Participant Flow|Part A - Placebo|"Placebo (D5W) IV Q4H x 48 h~Placebo: Placebo will be administered every 4 hours"
11237892|NCT02459418|FG001|Participant Flow|Gonal-f® RFF Then AFOLIA|"On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.~Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 IU Gonal-f® RFF, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.~Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation of 225 IU AFOLIA on study day 27. Exit examinations were performed on study day 35."
11237893|NCT02459418|OG000|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
11237894|NCT02459418|OG001|Outcome|Gonal-f® RFF|All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
11237895|NCT02459418|OG000|Outcome|AFOLIA|All subjects who received the test product AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
11237896|NCT02459418|OG001|Outcome|Gonal-f® RFF|All subjects who received the test product Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
11237897|NCT02459418|OG000|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
11237898|NCT02459418|EG000|Reported Event|AFOLIA|This analysis set contained all subjects who received one dose of AFOLIA (225 IU).
11237899|NCT02459418|EG001|Reported Event|Gonal-f® RFF|This analysis set contained all subjects who received one dose of Gonal-f® RFF (225 IU).
11237900|NCT02459587|BG000|Baseline|Crisis Line Facilitation|Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.
11237901|NCT02459587|BG001|Baseline|Enhanced Usual Care|Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
11237902|NCT02459587|BG002|Baseline|Total|Total of all reporting groups
11237903|NCT02459587|FG000|Participant Flow|Crisis Line Facilitation|Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.
11237904|NCT02459587|FG001|Participant Flow|Enhanced Usual Care|Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
11237905|NCT02459587|OG000|Outcome|Crisis Line Facilitation|Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis
11237906|NCT02459587|OG001|Outcome|Enhanced Usual Care|Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
11237907|NCT02459587|OG000|Outcome|Crisis Line Facilitation|Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.
11237908|NCT02459587|EG000|Reported Event|Crisis Line Facilitation|Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.
11237909|NCT02459587|EG001|Reported Event|Enhanced Usual Care|Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
11237910|NCT02459665|BG000|Baseline|Control|Behavioral counseling only
11237911|NCT02459665|BG001|Baseline|Oral Metronidazole|Oral metronidazole 2-month intermittent use plus counseling
11237912|NCT02459665|BG002|Baseline|Ecologic Femi+|Ecologic Femi+ vaginal probiotic capsule 2-month intermittent use plus counseling
11237913|NCT02459665|BG003|Baseline|Gynophilus LP|Gynophilus LP vaginal probiotic tablet 2-month intermittent use plus counseling
11237914|NCT02459665|BG004|Baseline|Total|Total of all reporting groups
11237915|NCT02459665|FG000|Participant Flow|Control|Behavioral counseling only
11237916|NCT02459665|FG001|Participant Flow|Oral Metronidazole|Oral metronidazole 2-month intermittent use plus counseling
11237917|NCT02459665|FG002|Participant Flow|Ecologic Femi+|Ecologic Femi+ vaginal probiotic capsule 2-month intermittent use plus counseling
11237918|NCT02459665|FG003|Participant Flow|Gynophilus LP|Gynophilus LP vaginal probiotic tablet 2-month intermittent use plus counseling
11237919|NCT02459665|OG000|Outcome|Control|Behavioral counseling only
11237920|NCT02459665|OG001|Outcome|Oral Metronidazole|Oral metronidazole 2-months intermittent use plus counseling
11237921|NCT02459665|OG002|Outcome|Ecologic Femi+|Ecologic Femi+ vaginal probiotic capsules 2-months intermittent use plus counseling
11237922|NCT02459665|OG003|Outcome|Gynophilus LP|Gynophilus LP vaginal probiotic tablets 2-months intermittent use plus counseling
11237923|NCT02459665|OG000|Outcome|Control Arm|Behavioral counseling only
11237924|NCT02459665|OG001|Outcome|Metronidazole Arm|Counseling plus 2-month intermittent use of oral metronidazole
11237925|NCT02459665|OG002|Outcome|Ecologic Femi+ Arm|Counseling plus 2-month intermittent use of Ecologic Femi+ vaginal probiotic capsule
11237926|NCT02459665|OG003|Outcome|Gynophilus LP Arm|Counseling plus 2-month intermittent use of Gynophilus LP vaginal probiotic tablet
11237927|NCT02459665|OG000|Outcome|Oral Metronidazole|Oral metronidazole 2-months intermittent use plus counseling
11237928|NCT02459665|OG001|Outcome|Ecologic Femi+|Ecologic Femi+ vaginal probiotic capsules 2-months intermittent use plus counseling
11237929|NCT02459665|OG002|Outcome|Gynophilus LP|Gynophilus LP vaginal probiotic tablets 2-months intermittent use plus counseling
11237930|NCT02459665|EG000|Reported Event|Control|Behavioral counseling only
11186479|NCT02100748|FG006|Participant Flow|Part B - TRV130 0.5 mg|"TRV130 0.5 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186480|NCT02100748|FG007|Participant Flow|Part B - TRV130 1 mg|"TRV130 1 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186481|NCT02100748|FG008|Participant Flow|Part B - TRV130 2 mg|"TRV130 2 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186482|NCT02100748|FG009|Participant Flow|Part B - TRV130 3 mg|"TRV130 3 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186483|NCT02100748|FG010|Participant Flow|Part B - Placebo|"Placebo (D5W) IV Q3H x 48 h~Placebo: Placebo will be administered every 3 hours"
11186484|NCT02100748|FG011|Participant Flow|Part B - Morphine|"Morphine 4 mg IV Q4H x 48 h~Morphine: Morphine 4 mg will be administered every 4 hours"
11186485|NCT02100748|OG000|Outcome|Part A - TRV130 1 mg|"TRV130 1 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186486|NCT02100748|OG001|Outcome|Part A - TRV130 2 mg|"TRV130 2 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186487|NCT02100748|OG002|Outcome|Part A - TRV130 3 mg|"TRV130 3 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186488|NCT02100748|OG003|Outcome|Part A - TRV130 4 mg|"TRV130 4 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186489|NCT02100748|OG004|Outcome|Part A - Morphine|"Morphine 4 mg IV Q4H x 48 h~Morphine: Morphine 4 mg will be administered every 4 hours"
11186490|NCT02100748|OG005|Outcome|Part A - Placebo|"Placebo (D5W) IV Q4H x 48 h~Placebo: Placebo will be administered every 4 hours"
11186491|NCT02100748|OG006|Outcome|Part B - TRV130 0.5 mg|"TRV130 0.5 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186492|NCT02100748|OG007|Outcome|Part B - TRV130 1 mg|"TRV130 1 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186493|NCT02100748|OG008|Outcome|Part B - TRV130 2 mg|"TRV130 2 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186494|NCT02100748|OG009|Outcome|Part B - TRV130 3 mg|"TRV130 3 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186495|NCT02100748|OG010|Outcome|Part B - Placebo|"Placebo (D5W) IV Q3H x 48 h~Placebo: Placebo will be administered every 3 hours"
11186496|NCT02100748|OG011|Outcome|Part B - Morphine|"Morphine 4 mg IV Q4H x 48 h~Morphine: Morphine 4 mg will be administered every 4 hours"
11186497|NCT02100748|EG000|Reported Event|Part A - TRV130 1 mg|"TRV130 1 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
10961943|NCT00863746|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
11186498|NCT02100748|EG001|Reported Event|Part A - TRV130 2 mg|"TRV130 2 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
10961944|NCT00863746|OG001|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
11186499|NCT02100748|EG002|Reported Event|Part A - TRV130 3 mg|"TRV130 3 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186500|NCT02100748|EG003|Reported Event|Part A - TRV130 4 mg|"TRV130 4 mg IV Q4H x 48 h~TRV130: TRV130 1 - 4 mg will be administered every 4 hours"
11186501|NCT02100748|EG004|Reported Event|Part A - Morphine|"Morphine 4 mg IV Q4H x 48 h~Morphine: Morphine 4 mg will be administered every 4 hours"
11186502|NCT02100748|EG005|Reported Event|Part A - Placebo|"Placebo (D5W) IV Q4H x 48 h~Placebo: Placebo will be administered every 4 hours"
11186503|NCT02100748|EG006|Reported Event|Part B - TRV130 0.5 mg|"TRV130 0.5 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186504|NCT02100748|EG007|Reported Event|Part B - TRV130 1 mg|"TRV130 1 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186505|NCT02100748|EG008|Reported Event|Part B - TRV130 2 mg|"TRV130 2 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186506|NCT02100748|EG009|Reported Event|Part B - TRV130 3 mg|"TRV130 3 mg IV Q3H x 48 h~TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours"
11186507|NCT02100748|EG010|Reported Event|Part B - Placebo|"Placebo (D5W) IV Q3H x 48 h~Placebo: Placebo will be administered every 3 hours"
11186508|NCT02100748|EG011|Reported Event|Part B - Morphine|"Morphine 4 mg IV Q4H x 48 h~Morphine: Morphine 4 mg will be administered every 4 hours"
11186509|NCT02100813|BG000|Baseline|Part 1 - 0.018% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp."
11186510|NCT02100813|BG001|Baseline|Part 1 - 0.025% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp."
11186511|NCT02100813|BG002|Baseline|Part 1 - 0.037% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp."
11186512|NCT02100813|BG003|Baseline|Part 1 - 0.05% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp."
11186513|NCT02100813|BG004|Baseline|Part 1 - 0.075% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp."
11186514|NCT02100813|BG005|Baseline|Part 2 - Vehicle|"Part 2 - Dose finding~Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp."
11186515|NCT02100813|BG006|Baseline|Part 2 - 0.037%|"Part 2 - Dose finding~Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp."
11186516|NCT02100813|BG007|Baseline|Part 2 - 0.05%|"Part 2 - Dose finding~Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp."
11186517|NCT02100813|BG008|Baseline|Total|Total of all reporting groups
11186518|NCT02100813|FG000|Participant Flow|Part 1 - 0.018% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel (ingenol disoxate) 0.018% for two consecutive days on balding scalp."
11186519|NCT02100813|FG001|Participant Flow|Part 1 - 0.025% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp."
11186520|NCT02100813|FG002|Participant Flow|Part 1 - 0.037% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp."
11186521|NCT02100813|FG003|Participant Flow|Part 1 - 0.05% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp."
11237931|NCT02459665|EG001|Reported Event|Oral Metronidazole|Oral metronidazole 2-months intermittent use plus counseling
11237932|NCT02459665|EG002|Reported Event|Ecologic Femi+|Ecologic Femi+ vaginal probiotic capsules 2-months intermittent use plus counseling
11237933|NCT02459665|EG003|Reported Event|Gynophilus LP|Gynophilus LP vaginal probiotic tablets 2-months intermittent use plus counseling
11237934|NCT02459795|BG000|Baseline|Test Product|"Ingenol Mebutate (Perrigo)~Ingenol Mebutate (Perrigo)"
11237935|NCT02459795|BG001|Baseline|Reference Product|"Ingenol Mebutate (Reference)~Ingenol Mebutate (Reference)"
11237936|NCT02459795|BG002|Baseline|Placebo Product|"Placebo gel~Placebo gel"
11237937|NCT02459795|BG003|Baseline|Total|Total of all reporting groups
11237938|NCT02459795|FG000|Participant Flow|Test Product|Ingenol Mebutate gel (Perrigo)
11237939|NCT02459795|FG001|Participant Flow|Reference Product|Ingenol Mebutate gel (Reference)
11237940|NCT02459795|FG002|Participant Flow|Placebo Product|"Placebo gel~Placebo gel"
11237941|NCT02459795|OG000|Outcome|Test Product|"Ingenol Mebutate (Perrigo)~Ingenol Mebutate (Perrigo)"
11237942|NCT02459795|OG001|Outcome|Reference Product|"Ingenol Mebutate (Reference)~Ingenol Mebutate (Reference)"
11237943|NCT02459795|OG002|Outcome|Placebo Product|"Placebo gel~Placebo gel"
11237944|NCT02459795|EG000|Reported Event|Test Product|"Ingenol Mebutate (Perrigo)~Ingenol Mebutate (Perrigo)"
11237945|NCT02459795|EG001|Reported Event|Reference Product|"Ingenol Mebutate (Reference)~Ingenol Mebutate (Reference)"
11237946|NCT02459795|EG002|Reported Event|Placebo Product|"Placebo gel~Placebo gel"
11237947|NCT02459899|BG000|Baseline|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
11237948|NCT02459899|BG001|Baseline|Sotagliflozin 75 mg|Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
11237949|NCT02459899|BG002|Baseline|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
11237950|NCT02459899|BG003|Baseline|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
11237951|NCT02459899|BG004|Baseline|Total|Total of all reporting groups
11237952|NCT02459899|FG000|Participant Flow|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
11237953|NCT02459899|FG001|Participant Flow|Sotagliflozin 75 mg|Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
11237954|NCT02459899|FG002|Participant Flow|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
11237955|NCT02459899|FG003|Participant Flow|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
11237956|NCT02459899|OG000|Outcome|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
11237957|NCT02459899|OG001|Outcome|Sotagliflozin 75 mg|Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
11237958|NCT02459899|OG002|Outcome|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
11237959|NCT02459899|OG003|Outcome|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
11237960|NCT02459899|EG000|Reported Event|Placebo|Two placebo-matching sotagliflozin tablets, once daily, orally, for 12 weeks.
11237961|NCT02459899|EG001|Reported Event|Sotagliflozin 75 mg|Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
11237962|NCT02459899|EG002|Reported Event|Sotagliflozin 200 mg|Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
11237963|NCT02459899|EG003|Reported Event|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
11237964|NCT02459951|BG000|Baseline|Hemiplegic Clenched Fist|"Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity.~clenched fist: Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant."
11237965|NCT02459951|FG000|Participant Flow|Hemiplegic Clenched Fist|"Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity.~clenched fist: Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant."
11237966|NCT02459951|OG000|Outcome|Hemiplegic Clenched Fist|"Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity.~clenched fist: Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant."
11237967|NCT02459951|OG000|Outcome|Clenched Fist|"Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity.~clenched fist: Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant."
11237968|NCT02459951|EG000|Reported Event|Hemiplegic Clenched Fist|"Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity.~clenched fist: Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant."
11359078|NCT03277183|EG000|Reported Event|Low Dose Erythropoietin|"Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly~Low dose erythropoietin: Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly"
11359079|NCT03277183|EG001|Reported Event|High Dose Erythropoietin|"Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks~High dose erythropoietin: Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks"
11359080|NCT03269968|BG000|Baseline|Negative Pressure Wound Therapy (NPWT)|"Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.~Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System."
11359081|NCT03269968|BG001|Baseline|Standard Dressing|"Standard dressing~Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing."
11359082|NCT03269968|BG002|Baseline|Total|Total of all reporting groups
11359083|NCT03269968|FG000|Participant Flow|Negative Pressure Wound Therapy (NPWT)|"Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.~Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System."
11359084|NCT03269968|FG001|Participant Flow|Standard Dressing|"Standard dressing~Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing."
11359085|NCT03269968|OG000|Outcome|Negative Pressure Wound Therapy (NPWT)|"Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.~Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System."
11359086|NCT03269968|OG001|Outcome|Standard Dressing|"Standard dressing~Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing."
11359087|NCT03269968|EG000|Reported Event|Negative Pressure Wound Therapy (NPWT)|"Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.~Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System."
11359088|NCT03269968|EG001|Reported Event|Standard Dressing|"Standard dressing~Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing."
11359089|NCT03248141|BG000|Baseline|Hemophilia A Cohort|Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [<=]5 percent[%] or severe: clotting factor level of less than [<]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.
11359090|NCT03248141|BG001|Baseline|Hemophilia B Cohort|Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level <=5% or severe: clotting factor level of <1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.
11359091|NCT03248141|BG002|Baseline|Total|Total of all reporting groups
11359092|NCT03248141|FG000|Participant Flow|Hemophilia A Cohort|Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [<=]5 percent[%] or severe: clotting factor level of less than [<]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.
11359093|NCT03248141|FG001|Participant Flow|Hemophilia B Cohort|Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level <=5% or severe: clotting factor level of <1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.
11359094|NCT03248141|OG000|Outcome|Hemophilia A Cohort|Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [<=]5 percent[%] or severe: clotting factor level of less than [<]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.
11359095|NCT03248141|OG001|Outcome|Hemophilia B Cohort|Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level <=5% or severe: clotting factor level of <1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.
10847276|NCT00282464|EG000|Reported Event|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
11359096|NCT03248141|EG000|Reported Event|Hemophilia A Cohort|Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [<=]5 percent[%] or severe: clotting factor level of less than [<]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.
11359097|NCT03248141|EG001|Reported Event|Hemophilia B Cohort|Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level <=5% or severe: clotting factor level of <1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.
11359098|NCT03263806|BG000|Baseline|SOC Group Management|"Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.~SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment"
11359099|NCT03263806|BG001|Baseline|CTFFR-Guided Group Management|"Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.~CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway."
11359100|NCT03263806|BG002|Baseline|Total|Total of all reporting groups
11359101|NCT03263806|FG000|Participant Flow|SOC Group Management|"Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.~SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment"
11359102|NCT03263806|FG001|Participant Flow|CTFFR-Guided Group Management|"Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.~CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway."
11359103|NCT03263806|OG000|Outcome|SOC Group Management|"Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.~SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment"
11359104|NCT03263806|OG001|Outcome|CTFFR-Guided Group Management|"Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.~CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway."
11359105|NCT03263806|EG000|Reported Event|SOC Group Management|"Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.~SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment"
11359106|NCT03263806|EG001|Reported Event|CTFFR-Guided Group Management|"Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.~CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway."
11359107|NCT03261531|BG000|Baseline|Transcutaneous Electrical Nerve Stimulation (TENS)|"Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)~Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit."
11359108|NCT03261531|FG000|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS)|"Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)~Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit."
11359109|NCT03261531|OG000|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|"Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)~Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit."
10847277|NCT00282464|EG001|Reported Event|Placebo|
10849893|NCT00299130|FG001|Participant Flow|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11237969|NCT02459964|BG000|Baseline|Treatment Arm 1 (Intranasal Fentanyl)|Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
11237970|NCT02459964|BG001|Baseline|Treatment Arm 2 (Intravenous Hydromorphone)|Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
11237971|NCT02459964|BG002|Baseline|No Medication Administered|1 Participant decided not to participate after signing the consent form; 1 Participant was found to have abnormal EKG changes with hypokalemia, hence removed from the study.
11237972|NCT02459964|BG003|Baseline|Total|Total of all reporting groups
11237973|NCT02459964|FG000|Participant Flow|Treatment Arm 1 (Intranasal Fentanyl)|Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
11237974|NCT02459964|FG001|Participant Flow|Treatment Arm 2 (Intravenous Hydromorphone)|Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
11237975|NCT02459964|FG002|Participant Flow|No Medication Administered|1 Participant decided not to participate after signing the consent form; 1 Participant was found to have abnormal EKG changes with hypokalemia, hence removed from the study.
11237976|NCT02459964|OG000|Outcome|Treatment Arm 1 (Intranasal Fentanyl)|Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
11237977|NCT02459964|OG001|Outcome|Treatment Arm 2 (Intravenous Hydromorphone)|Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
11237978|NCT02459964|EG000|Reported Event|Treatment Arm 1 (Intranasal Fentanyl)|Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
11237979|NCT02459964|EG001|Reported Event|Treatment Arm 2 (Intravenous Hydromorphone)|Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
11237980|NCT02459964|EG002|Reported Event|No Medication Administered|1 Participant decided not to participate after signing the consent form; 1 Participant was found to have abnormal EKG changes with hypokalemia, hence removed from the study.
11237981|NCT02460172|BG000|Baseline|All Participants|"Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.~Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.~Steel Staples: Skin closure device for the closure of the skin layer following surgical incision."
11237982|NCT02460172|FG000|Participant Flow|All Participants|"Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.~Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.~Steel Staples: Skin closure device for the closure of the skin layer following surgical incision."
11237983|NCT02460172|OG000|Outcome|Zip Surgical Skin Closure|"Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.~Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.~Steel Staples: Skin closure device for the closure of the skin layer following surgical incision."
11237984|NCT02460172|OG001|Outcome|Steel Staples|"Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.~Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.~Steel Staples: Skin closure device for the closure of the skin layer following surgical incision."
11237985|NCT02460172|EG000|Reported Event|Zip Surgical Skin Closure|"Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.~Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.~Steel Staples: Skin closure device for the closure of the skin layer following surgical incision."
11237986|NCT02460172|EG001|Reported Event|Steel Staples|"Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.~Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.~Steel Staples: Skin closure device for the closure of the skin layer following surgical incision."
11237987|NCT02460263|BG000|Baseline|Intention-To-Treat (ITT) Population|The ITT population was defined as all participants who were enrolled and fulfilled inclusion criteria.
11237988|NCT02460263|FG000|Participant Flow|In-Center Dialysis, Then In-Home Dialysis|"Subjects first entered the In-Center period of the trial before transitioning to the In-Home period. Dialysis treatments were based on physician prescription (clearance and volume targets) and included the following schedules:~Treatment Period 1, In-Center - Subjects received study staff administered dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)~In-Home Transition- Subjects received device training and performed self-care dialysis 4 times/week for approximately 4 weeks, and were assessed for stability in the new care environment.~Treatment Period 2, In-Home - Subjects received self-care dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)"
11237989|NCT02460263|OG000|Outcome|In-Center|Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system
11237990|NCT02460263|OG001|Outcome|In-Home|Participants administered hemodialysis treatments In-Home using the Tablo system
11237991|NCT02460263|OG000|Outcome|In-Center|Staff administered hemodialysis treatments for participants In-Center using the Tablo system
11237992|NCT02460263|EG000|Reported Event|In-Center|Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system
10961945|NCT00863746|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (BID)
10961946|NCT00863746|EG001|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
11237993|NCT02460263|EG001|Reported Event|Transition Period|Staff and participant administered hemodialysis treatments using the Tablo system
11237994|NCT02460263|EG002|Reported Event|In-Home|Participants administered hemodialysis treatments In-Home using the Tablo system
11237995|NCT02460380|BG000|Baseline|Vitamin D3|"Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.~Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks."
11237996|NCT02460380|BG001|Baseline|Placebo|"Women in the placebo group received once capsule of placebo once weekly for eight weeks.~Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks"
11237997|NCT02460380|BG002|Baseline|Total|Total of all reporting groups
11237998|NCT02460380|FG000|Participant Flow|Vitamin D3|"Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.~Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks."
11237999|NCT02460380|FG001|Participant Flow|Placebo|"Women in the placebo group received once capsule of placebo once weekly for eight weeks.~Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks"
11238000|NCT02460380|OG000|Outcome|Vitamin D3|"Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.~Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks."
11238001|NCT02460380|OG001|Outcome|Placebo|"Women in the placebo group received once capsule of placebo once weekly for eight weeks.~Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks"
11238002|NCT02460380|OG000|Outcome|Vitamin D3 Group Before Treatment|"Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.~Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks."
11238003|NCT02460380|EG000|Reported Event|Vitamin D3|"Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.~Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks."
11238004|NCT02460380|EG001|Reported Event|Placebo|"Women in the placebo group received once capsule of placebo once weekly for eight weeks.~Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks"
11238005|NCT02460562|BG000|Baseline|PMMA Resin|"A denture base was made with PMMA resin as a standard material.~PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness."
11238006|NCT02460562|BG001|Baseline|PMMA Resin & S-PRG Filler|"A denture base was made from PMMA resin containing S-PRG fillers for subject to wear.~Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention.~The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567.~PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that inc"
11238007|NCT02460562|BG002|Baseline|Total|Total of all reporting groups
11238008|NCT02460562|FG000|Participant Flow|PMMA Resin|"A denture base was made with PMMA resin as a standard material.~PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness."
11238009|NCT02460562|FG001|Participant Flow|PMMA Resin & S-PRG Filler|"A denture base was made from PMMA resin containing S-PRG fillers for subject to wear.~Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention.~The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567.~PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that inc"
11238010|NCT02460562|OG000|Outcome|PMMA Resin|"A denture base was made with PMMA resin as a standard material.~PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness."
11238011|NCT02460562|OG001|Outcome|PMMA Resin & S-PRG Filler|"A denture base was made from PMMA resin containing S-PRG fillers.~Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions including fluoride to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention.~The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567."
11359110|NCT03261531|EG000|Reported Event|Transcutaneous Electrical Nerve Stimulation (TENS)|"Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)~Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit."
11359111|NCT03219372|BG000|Baseline|Pravastatin Pill|"Pravastatin 40 mg, daily for 12 months~Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase."
11359112|NCT03219372|BG001|Baseline|Placebo Oral Tablet|"Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months~Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent."
11359113|NCT03219372|BG002|Baseline|Total|Total of all reporting groups
11359114|NCT03219372|FG000|Participant Flow|Pravastatin Pill|"Pravastatin 40 mg, daily for 12 months~Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase."
11359115|NCT03219372|FG001|Participant Flow|Placebo Oral Tablet|"Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months~Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent."
11359116|NCT03219372|OG000|Outcome|Pravastatin Pill|"Pravastatin 40 mg, daily for 12 months~Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase."
11359117|NCT03219372|OG001|Outcome|Placebo Oral Tablet|"Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months~Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent."
11359118|NCT03219372|EG000|Reported Event|Pravastatin Pill|"Pravastatin 40 mg, daily for 12 months~Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase."
11359119|NCT03219372|EG001|Reported Event|Placebo Oral Tablet|"Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months~Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent."
11359120|NCT03217175|BG000|Baseline|Whole Study|All subjects enrolled. The study was terminated before most subjects were able to be randomized.
11359121|NCT03217175|FG000|Participant Flow|Bihormonal Bionic Pancreas First, Then Insulin-Only|"Insulin-only bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).~Placebo: Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas~Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.~Glucagon: Glucagon will be given according to the algorithm in the bihormonal bionic pancreas"
11359122|NCT03217175|FG001|Participant Flow|Insulin Only Bionic Pancreas First, Then Bihormonal|"Insulin-only bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).~Placebo: Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas~Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.~Glucagon: Glucagon will be given according to the algorithm in the bihormonal bionic pancreas"
11359123|NCT03217175|OG000|Outcome|Bihormonal Bionic Pancreas|"Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bihormonal bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.~Bihormonal Bionic Pancreas: The glucagon pump will be filled with glucagon during the exercise visit~Glucagon: Glucagon will be given according to the algorithm in the bihormonal bionic pancreas"
11359124|NCT03217175|OG001|Outcome|Insulin Only Bionic Pancreas|"Insulin-only bionic pancreas exercise visit - Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bihormonal bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).~Insulin Only Bionic Pancreas: The glucagon pump will be filled with placebo during the exercise visit, and the bionic pancreas will operate in an insulin only mode.~Placebo: Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas"
11359125|NCT03217175|EG000|Reported Event|Bihormonal Bionic Pancreas|Adverse events for participants in the bihormonal bionic pancreas arm are reported here.
11359126|NCT03217175|EG001|Reported Event|Insulin-only Bionic Pancreas|Adverse events for participants in the insulin-only bionic pancreas arm are reported here.
10961947|NCT00863772|BG000|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
10961948|NCT00863772|BG001|Baseline|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
10961949|NCT00863772|BG002|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
10961950|NCT00863772|BG003|Baseline|Total|Total of all reporting groups
11238012|NCT02460562|EG000|Reported Event|PMMA Resin|"A denture base was made with PMMA resin as a standard material.~PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness."
11238013|NCT02460562|EG001|Reported Event|PMMA Resin & S-PRG Filler|"A denture base was made from PMMA resin containing S-PRG fillers for subject to wear.~Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention.~The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567.~PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that inc"
11238014|NCT02460575|BG000|Baseline|Lactobacillus|"Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops.~Lactobacillus reuteri 17938: probiotic"
11238015|NCT02460575|BG001|Baseline|Placebo|"Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.~Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops."
11238016|NCT02460575|BG002|Baseline|Total|Total of all reporting groups
11238017|NCT02460575|FG000|Participant Flow|Lactobacillus|"Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops.~Lactobacillus reuteri 17938: probiotic"
11238018|NCT02460575|FG001|Participant Flow|Placebo|"Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.~Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops."
11238019|NCT02460575|OG000|Outcome|Lactobacillus|"Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops.~Lactobacillus reuteri 17938: probiotic"
11238020|NCT02460575|OG001|Outcome|Placebo|"Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.~Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops."
11238021|NCT02460575|EG000|Reported Event|Lactobacillus|"Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops.~Lactobacillus reuteri 17938: probiotic"
11238022|NCT02460575|EG001|Reported Event|Placebo|"Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.~Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops."
11238023|NCT02460666|BG000|Baseline|Tai-Chi Chih Classes|"Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.~Tai-Chi-Chih (TCC)"
11238024|NCT02460666|BG001|Baseline|Health Education and Wellness Classes|"Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.~Health Education and Wellness Classes (HEW)"
11238025|NCT02460666|BG002|Baseline|Total|Total of all reporting groups
11238026|NCT02460666|FG000|Participant Flow|Tai-Chi Chih Classes|"Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.~Tai-Chi-Chih (TCC)"
11238027|NCT02460666|FG001|Participant Flow|Health Education and Wellness Classes|"Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.~Health Education and Wellness Classes (HEW)"
11238028|NCT02460666|OG000|Outcome|Tai-Chi Chih Classes|"Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.~Tai-Chi-Chih (TCC)"
11238029|NCT02460666|OG001|Outcome|Health Education and Wellness Classes|"Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.~Health Education and Wellness Classes (HEW)"
11238030|NCT02460666|EG000|Reported Event|Tai-Chi Chih Classes|"Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.~Tai-Chi-Chih (TCC)"
11238031|NCT02460666|EG001|Reported Event|Health Education and Wellness Classes|"Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.~Health Education and Wellness Classes (HEW)"
11238032|NCT02460679|BG000|Baseline|EPI-589|Participants received EPI-589 500 mg (2 tablets of 250 mg each) BID for 3 months, unless discontinued for safety or tolerability issues.
11238033|NCT02460679|FG000|Participant Flow|EPI-589|Participants received EPI-589 500 milligrams (mg) (2 tablets of 250 mg each) twice daily (BID) for 3 months, unless discontinued for safety or tolerability issues.
11238034|NCT02460679|OG000|Outcome|EPI-589|Participants received EPI-589 500 mg (2 tablets of 250 mg each) BID for 3 months, unless discontinued for safety or tolerability issues.
10961951|NCT00863772|FG000|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
11238035|NCT02460679|EG000|Reported Event|EPI-589|Participants received EPI-589 500 mg (2 tablets of 250 mg each) BID for 3 months, unless discontinued for safety or tolerability issues.
11238036|NCT02460822|BG000|Baseline|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
11186522|NCT02100813|FG004|Participant Flow|Part 1 - 0.075% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp."
11186523|NCT02100813|FG005|Participant Flow|Part 2 - Vehicle|"Part 2 - Dose finding~Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp."
11186524|NCT02100813|FG006|Participant Flow|Part 2 - 0.037%|"Part 2 - Dose finding~Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp."
11186525|NCT02100813|FG007|Participant Flow|Part 2 - 0.05%|"Part 2 - Dose finding~Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp."
11186526|NCT02100813|OG000|Outcome|Part 1 - 0.018% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp."
11186527|NCT02100813|OG001|Outcome|Part 1 - 0.025% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp."
11186528|NCT02100813|OG002|Outcome|Part 1 - 0.037% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp."
11186529|NCT02100813|OG003|Outcome|Part 1 - 0.05% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp."
11186530|NCT02100813|OG004|Outcome|Part 1 - 0.075% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp."
11186531|NCT02100813|OG000|Outcome|Part 2 - Vehicle|"Part 2 - Dose finding~Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp."
11186532|NCT02100813|OG001|Outcome|Part 2 - 0.037%|"Part 2 - Dose finding~Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp."
11186533|NCT02100813|OG002|Outcome|Part 2 - 0.05%|"Part 2 - Dose finding~Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp."
11186534|NCT02100813|EG000|Reported Event|Part 1 - 0.018% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp."
11186535|NCT02100813|EG001|Reported Event|Part 1 - 0.025% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.025%for two consecutive days on balding scalp."
11186536|NCT02100813|EG002|Reported Event|Part 1 - 0.037% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp."
11186537|NCT02100813|EG003|Reported Event|Part 1 - 0.05% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp."
11186538|NCT02100813|EG004|Reported Event|Part 1 - 0.075% Cohort|"Part 1 - Dose escalation~Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp."
10961952|NCT00863772|FG001|Participant Flow|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
11186539|NCT02100813|EG005|Reported Event|Part 2 - Vehicle|"Part 2 - Dose finding~Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp."
11186540|NCT02100813|EG006|Reported Event|Part 2 - 0.037%|"Part 2 - Dose finding~Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp."
11186541|NCT02100813|EG007|Reported Event|Part 2 - 0.05%|"Part 2 - Dose finding~Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp."
11186542|NCT02100826|BG000|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).
11186543|NCT02100826|FG000|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses.
11186544|NCT02100826|FG001|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses.
11186545|NCT02100826|OG000|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
11186546|NCT02100826|OG001|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11186547|NCT02100826|EG000|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
11186548|NCT02100826|EG001|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11186549|NCT02100839|BG000|Baseline|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
11186550|NCT02100839|BG001|Baseline|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
11186551|NCT02100839|BG002|Baseline|Total|Total of all reporting groups
11186552|NCT02100839|FG000|Participant Flow|Apolipoprotein E Mimetic (AEM)-28|"Single Ascending Dose (SAD): Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose (MAD): Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
11186553|NCT02100839|FG001|Participant Flow|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
11186554|NCT02100839|OG000|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
11186555|NCT02100839|OG001|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
11186556|NCT02100839|EG000|Reported Event|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
11186557|NCT02100839|EG001|Reported Event|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
11186558|NCT02100930|BG000|Baseline|Neuroblastoma|"This is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients.~Anti-GD2 3F8 Monoclonal Antibody~GM-CSF (granulocyte-macrophage colony-stimulating factor)~oral isotretinoin"
11359127|NCT03231397|BG000|Baseline|Control Group|"Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359128|NCT03231397|BG001|Baseline|Small AAA's|"Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359129|NCT03231397|BG002|Baseline|Rapidly Expanding AAA's|"Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359130|NCT03231397|BG003|Baseline|AAA's Undergoing Treatment|"Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359131|NCT03231397|BG004|Baseline|Total|Total of all reporting groups
11359132|NCT03231397|FG000|Participant Flow|Control Group|"Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359133|NCT03231397|FG001|Participant Flow|Small AAA's|"Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11186559|NCT02100930|FG000|Participant Flow|Neuroblastoma|"This is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients.~Anti-GD2 3F8 Monoclonal Antibody~GM-CSF (granulocyte-macrophage colony-stimulating factor)~oral isotretinoin"
10961953|NCT00863772|FG002|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
11186560|NCT02100930|OG000|Outcome|Neuroblastoma|"This is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients.~Anti-GD2 3F8 Monoclonal Antibody~GM-CSF (granulocyte-macrophage colony-stimulating factor)~oral isotretinoin"
10961954|NCT00863772|OG000|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
11359134|NCT03231397|FG002|Participant Flow|Rapidly Expanding AAA's|"Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359135|NCT03231397|FG003|Participant Flow|AAA's Undergoing Treatment|"Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359136|NCT03231397|OG000|Outcome|Control Group|"Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359137|NCT03231397|OG001|Outcome|Small AAA's|"Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359138|NCT03231397|OG002|Outcome|Rapidly Expanding AAA's|"Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359139|NCT03231397|OG003|Outcome|AAA's Undergoing Treatment|"Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359140|NCT03231397|EG000|Reported Event|Control Group|"Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359141|NCT03231397|EG001|Reported Event|Small AAA's|"Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359142|NCT03231397|EG002|Reported Event|Rapidly Expanding AAA's|"Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11186561|NCT02100930|EG000|Reported Event|Neuroblastoma|"This is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients.~Anti-GD2 3F8 Monoclonal Antibody~GM-CSF (granulocyte-macrophage colony-stimulating factor)~oral isotretinoin"
11186562|NCT02100969|BG000|Baseline|Hizentra|"Hizentra is a subcutaneous (under the skin) immunoglobin (SCIg). Participants will receive weekly Hizentra. Dose and rate depend on the visit and how each participant tolerates the drug. Max flow rate not to exceed 100 mL per hour.~HIZENTRA ®"
11186563|NCT02100969|FG000|Participant Flow|Privigen/Hizentra|"Privigen: 3 rounds of IV privigen was infused every 4 weeks until baseline visit week 0.~Hizentra: Hizentra infused sub cutaneously based on weight and subject prescribed dose."
11186564|NCT02100969|OG000|Outcome|Hizentra|"Hizentra is a subcutaneous (under the skin) immunoglobin (SCIg). Participants will receive weekly Hizentra. Dose and rate depend on the visit and how each participant tolerates the drug. Max flow rate not to exceed 100 mL per hour.~HIZENTRA ®"
11186565|NCT02100969|OG000|Outcome|HIZENTRA ®|"Hizentra is a subcutaneous (under the skin) immunoglobin (SCIg). Participants will receive Hizentra in a minimum of one infusion per week and a maximum of 4 infusions per week. Dose and rate depend on the visit and how each participant tolerates the drug. Max cc per site is 50 cc per site per hour.~HIZENTRA ®: Patients must fulfill inclusion criteria and remain stable at week 0, which means QMG does not increase by 3 points, will enter receive Hizentra for 12 weeks."
11186566|NCT02100969|EG000|Reported Event|Privigen/Hizentra|Experimental Treatment arm: Privigen/Hizentra assigned to subjects who are stable in the screening phase of the study.
11186567|NCT02101008|BG000|Baseline|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.~disulfiram and chelated zinc"
11186568|NCT02101008|FG000|Participant Flow|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
11186569|NCT02101008|OG000|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
11186570|NCT02101008|EG000|Reported Event|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.~disulfiram and chelated zinc"
11186571|NCT02101021|BG000|Baseline|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186572|NCT02101021|BG001|Baseline|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186573|NCT02101021|BG002|Baseline|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186574|NCT02101021|BG003|Baseline|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186575|NCT02101021|BG004|Baseline|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186576|NCT02101021|BG005|Baseline|Total|Total of all reporting groups
11186577|NCT02101021|FG000|Participant Flow|MMB Dose Level 1|Momelotinib (MMB) 100 mg tablet once daily + albumin-bound (nab)-paclitaxel plus gemcitabine (nab-P+G) (1000+1000 mg/m^2) intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle
11186578|NCT02101021|FG001|Participant Flow|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186579|NCT02101021|FG002|Participant Flow|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186580|NCT02101021|FG003|Participant Flow|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186581|NCT02101021|FG004|Participant Flow|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186582|NCT02101021|OG000|Outcome|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186583|NCT02101021|OG001|Outcome|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186584|NCT02101021|OG002|Outcome|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186585|NCT02101021|OG003|Outcome|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186586|NCT02101021|OG004|Outcome|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186587|NCT02101021|EG000|Reported Event|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186588|NCT02101021|EG001|Reported Event|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186589|NCT02101021|EG002|Reported Event|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186590|NCT02101021|EG003|Reported Event|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186591|NCT02101021|EG004|Reported Event|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
11186592|NCT02101060|BG000|Baseline|Exercise|"16-week progressive aerobic and resistance exercise training~exercise: 16-week progressive aerobic and resistance exercise training"
11186593|NCT02101060|BG001|Baseline|Control|usual care controls
11186594|NCT02101060|BG002|Baseline|Total|Total of all reporting groups
11186595|NCT02101060|FG000|Participant Flow|Exercise|"16-week progressive aerobic and resistance exercise training~exercise: 16-week progressive aerobic and resistance exercise training"
11186596|NCT02101060|FG001|Participant Flow|Control|usual care controls
11238037|NCT02460822|FG000|Participant Flow|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
11238038|NCT02460822|OG000|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
11238039|NCT02460822|EG000|Reported Event|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
11238040|NCT02460978|BG000|Baseline|DAPA 5 MG + INS|Dapagliflozin 5 mg plus insulin
11238041|NCT02460978|BG001|Baseline|DAPA 10 MG + INS|Dapagliflozin 10 mg plus insulin
11238042|NCT02460978|BG002|Baseline|PLA + INS|Placebo plus insulin
11238043|NCT02460978|BG003|Baseline|Total|Total of all reporting groups
11238044|NCT02460978|FG000|Participant Flow|DAPA 5 MG + INS|Dapagliflozin 5 mg plus insulin
10961955|NCT00863772|OG001|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
10961956|NCT00863772|OG002|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
10961957|NCT00863772|EG000|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
10961958|NCT00863772|EG001|Reported Event|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
10961959|NCT00863772|EG002|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
10961960|NCT00863798|BG000|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
10961961|NCT00863798|BG001|Baseline|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
10961962|NCT00863798|BG002|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
10961963|NCT00863798|BG003|Baseline|Total|Total of all reporting groups
11238045|NCT02460978|FG001|Participant Flow|DAPA 10 MG + INS|Dapagliflozin 10 mg plus insulin
11238046|NCT02460978|FG002|Participant Flow|PLA + INS|Placebo plus insulin
11238047|NCT02460978|OG000|Outcome|DAPA 5 MG + INS|Dapagliflozin 5 mg plus insulin
11238048|NCT02460978|OG001|Outcome|DAPA 10 MG + INS|Dapagliflozin 10 mg plus insulin
11238049|NCT02460978|OG002|Outcome|PLA + INS|Placebo plus insulin
11238050|NCT02460978|EG000|Reported Event|DAPA 5 MG + INS|Dapagliflozin 5 mg plus insulin
11238051|NCT02460978|EG001|Reported Event|DAPA 10 MG + INS|Dapagliflozin 10 mg plus insulin
11238052|NCT02460978|EG002|Reported Event|PLA + INS|Placebo plus insulin
11238053|NCT02460991|BG000|Baseline|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved
11238054|NCT02460991|BG001|Baseline|Sorafenib|200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
11238055|NCT02460991|BG002|Baseline|Total|Total of all reporting groups
11238056|NCT02460991|FG000|Participant Flow|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved.
11238057|NCT02460991|FG001|Participant Flow|Sorafenib|200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
11238058|NCT02460991|OG000|Outcome|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved.
11238059|NCT02460991|OG001|Outcome|Sorafenib|200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
11238060|NCT02460991|OG000|Outcome|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved.
11238061|NCT02460991|OG001|Outcome|Sorafenib|200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
11238062|NCT02460991|OG000|Outcome|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved
11238063|NCT02460991|OG000|Outcome|DEB-TACE|"ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved.~DEB-TACE"
11238064|NCT02460991|OG001|Outcome|Sorafenib|"200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression~Sorafenib"
11238065|NCT02460991|EG000|Reported Event|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved
11238066|NCT02460991|EG001|Reported Event|Sorafenib|200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
11238067|NCT02461134|BG000|Baseline|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
11359143|NCT03231397|EG003|Reported Event|AAA's Undergoing Treatment|"Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.~To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.~Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans~18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging~11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging"
11359144|NCT03232892|BG000|Baseline|Trametinib 2.0mg PO Daily|"Trametinib 2.0mg PO daily in 28-day cycles. A maximum of two trametinib dose level reductions are allowed (1.5mg and 1mg) in the case of adverse reactions.~Trametinib: Trametinib 2mg, once daily, PO, 28-day cycles"
11359145|NCT03232892|FG000|Participant Flow|Trametinib 2.0mg PO Daily|"Trametinib 2.0mg PO daily in 28-day cycles. A maximum of two trametinib dose level reductions are allowed (1.5mg and 1mg) in the case of adverse reactions.~Trametinib: Trametinib 2mg, once daily, PO, 28-day cycles"
11359146|NCT03232892|OG000|Outcome|Trametinib 2.0mg PO Daily|"Trametinib 2.0mg PO daily in 28-day cycles. A maximum of two trametinib dose level reductions are allowed (1.5mg and 1mg) in the case of adverse reactions.~Trametinib: Trametinib 2mg, once daily, PO, 28-day cycles"
11359147|NCT03232892|EG000|Reported Event|Trametinib 2.0mg PO Daily|"Trametinib 2.0mg PO daily in 28-day cycles. A maximum of two trametinib dose level reductions are allowed (1.5mg and 1mg) in the case of adverse reactions.~Trametinib: Trametinib 2mg, once daily, PO, 28-day cycles"
11359148|NCT03223662|BG000|Baseline|Neoadjuvant Chemoradiotherapy and Esophagectomy|"Standard of care neoadjuvant chemoradiotherapy (nCRT) and esophagectomy~Chemoradiotherapy: Chemotherapy: Carboplatin (AUC=2)x5 and Paclitaxel (50 mg/m(2))x5 for two cycles. Radiation: a total dose of 40.4 Gray (Gy) will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.~Esophagectomy: Minimally-invasive esophagectomy (RAMIE) or traditional open approach if necessary."
11359149|NCT03223662|FG000|Participant Flow|Neoadjuvant Chemoradiotherapy and Esophagectomy|"Standard of care neoadjuvant chemoradiotherapy (nCRT) and esophagectomy~Chemoradiotherapy: Chemotherapy: Carboplatin (AUC=2)x5 and Paclitaxel (50 mg/m(2))x5 for two cycles. Radiation: a total dose of 40.4 Gray (Gy) will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.~Esophagectomy: Minimally-invasive esophagectomy (RAMIE) or traditional open approach if necessary."
11359150|NCT03223662|OG000|Outcome|Neoadjuvant Chemoradiotherapy and Esophagectomy|"Standard of care neoadjuvant chemoradiotherapy (nCRT) and esophagectomy~Chemoradiotherapy: Chemotherapy: Carboplatin (AUC=2)x5 and Paclitaxel (50 mg/m(2))x5 for two cycles. Radiation: a total dose of 40.4 Gray (Gy) will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.~Esophagectomy: Minimally-invasive esophagectomy (RAMIE) or traditional open approach if necessary."
11359151|NCT03223662|EG000|Reported Event|Neoadjuvant Chemoradiotherapy and Esophagectomy|"Standard of care neoadjuvant chemoradiotherapy (nCRT) and esophagectomy~Chemoradiotherapy: Chemotherapy: Carboplatin (AUC=2)x5 and Paclitaxel (50 mg/m(2))x5 for two cycles. Radiation: a total dose of 40.4 Gray (Gy) will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.~Esophagectomy: Minimally-invasive esophagectomy (RAMIE) or traditional open approach if necessary."
11359152|NCT03212144|BG000|Baseline|High Intensity Interval Training First Then Peanut Consumption|"High intensity interval training first then peanut consumption~High intensity interval training:~4 training sessions per week over a 4-week period, with 24hour rest-periods between each training day. Each session begins with a 3 min low intensity warm-up, and then participants exercise as rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the submaximal cardiopulmonary exercise testing. This 20 second period is followed by 40 seconds of low intensity exercise."
11359153|NCT03212144|BG001|Baseline|Peanut Consumption First Then High Intensity Interval Training|"Peanut consumption first then high intensity interval training~Peanut Consumption:~Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks. Daily caloric intake will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Peanuts replaces protein and fat containing foods so that the daily caloric intake will not differ from diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day."
11359154|NCT03212144|BG002|Baseline|Total|Total of all reporting groups
11359155|NCT03212144|FG000|Participant Flow|High Intensity Interval Training First Then Peanut Consumption|"Participants will engage in high intensity interval training first then peanut consumption~High intensity interval training:~4 training sessions per week over a 4-week period, with 24hour rest-periods between each training day. Each session begins with a 3 min low intensity warm-up, and then participants exercise as rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the submaximal cardiopulmonary exercise testing. This 20 second period is followed by 40 seconds of low intensity exercise."
11359156|NCT03212144|FG001|Participant Flow|Peanut Consumption First Then High Intensity Interval Training|"Peanut consumption first then high intensity interval Training~Peanut Consumption:~Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks.~Daily caloric intake will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Peanuts replaces protein and fat containing foods so that the daily caloric intake will not differ from diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day."
10961964|NCT00863798|FG000|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
10961965|NCT00863798|FG001|Participant Flow|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
10961966|NCT00863798|FG002|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
10961967|NCT00863798|OG000|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
10961968|NCT00863798|OG001|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
10961969|NCT00863798|OG002|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
10961970|NCT00863798|EG000|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
10961971|NCT00863798|EG001|Reported Event|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
10961972|NCT00863798|EG002|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
10961973|NCT00863928|BG000|Baseline|Control|no intervention
10961974|NCT00863928|BG001|Baseline|B & O Suppository|belladonna 16.2 mg and opium 60 mg suppository
10961975|NCT00863928|BG002|Baseline|Total|Total of all reporting groups
10961976|NCT00863928|FG000|Participant Flow|Control|no intervention
10961977|NCT00863928|FG001|Participant Flow|B & O Suppository|belladonna 16.2 mg and opium 60 mg suppository
10961978|NCT00863928|OG000|Outcome|Control|no intervention
10961979|NCT00863928|OG001|Outcome|B & O Suppository|belladonna 16.2 mg and opium 60 mg suppository
10961980|NCT00863928|EG000|Reported Event|Control|no intervention
10961981|NCT00863928|EG001|Reported Event|B & O Suppository|belladonna 16.2 mg and opium 60 mg suppository
10961982|NCT00864032|BG000|Baseline|Phase I|
10961983|NCT00864032|FG000|Participant Flow|Sorafenib 200/200|"Dose level 1 sorafenib 200 bid with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
10961984|NCT00864032|FG001|Participant Flow|Sorafenib 200/400|"Dose level 2 sorafenib 200 mg PO Q AM and 400 mg PO Q PM with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.~Traditional 3+3 dose escalation Phase I trial. Cohort 2 enrolled after completion of all 3 participants in dose level 1."
10961985|NCT00864032|FG002|Participant Flow|Sorafenib 400/400|"Dose level 3 sorafenib 400 mg PO BID with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
10961986|NCT00864032|OG000|Outcome|Sorafenib 200/200|
10961987|NCT00864032|OG001|Outcome|Sorafenib 200/400|
10961988|NCT00864032|EG000|Reported Event|Sorafenib 200/200|Dose level 1. Sorafenib 200 mg PO BID
10961989|NCT00864032|EG001|Reported Event|Sorafenib 200/400|Dose level 2. Sorafenib 200 mg PO Q AM and 400 mg PO Q PM
11238068|NCT02461134|FG000|Participant Flow|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
11238069|NCT02461134|OG000|Outcome|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
11238070|NCT02461134|EG000|Reported Event|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
11238071|NCT02461160|BG000|Baseline|SRD Cohorts Pooled Placebo|TAK-915 placebo-matching suspension, orally, once on Day 1.
11238072|NCT02461160|BG001|Baseline|SRD Cohort 1 TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1.
10961990|NCT00864084|BG000|Baseline|Pulmonary Rehabilitation|People with respiratory disease
10961991|NCT00864084|FG000|Participant Flow|Pulmonary Rehabilitation|An 8-week out-patient pulmonary rehabilitation program.
10961992|NCT00864084|OG000|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
10961993|NCT00864084|OG001|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
10961994|NCT00864084|OG002|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
10961995|NCT00864084|OG003|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
10961996|NCT00864084|OG000|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
11238073|NCT02461160|BG002|Baseline|SRD Cohort 2: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1.
11238074|NCT02461160|BG003|Baseline|SRD Cohort 3: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1.
11238075|NCT02461160|BG004|Baseline|MRD Cohorts Pooled Placebo|TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.
11238076|NCT02461160|BG005|Baseline|MRD Cohort 5: TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.
11238077|NCT02461160|BG006|Baseline|MRD Cohort 6: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.
11238078|NCT02461160|BG007|Baseline|MRD Cohort 7: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.
11238079|NCT02461160|BG008|Baseline|DDI Cohort 8: TAK-915 + Midazolam 2 mg|Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).
11238080|NCT02461160|BG009|Baseline|BA/FE Cohort 9 Group 1: A,B,C|Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1, followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3. Each period was separated out by a 6 to 14-day washout period.
11238081|NCT02461160|BG010|Baseline|BA/FE Cohort 10 Group 2: B,C,A|Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1. Each period was separated out by a 6 to 14-day washout period.
11238082|NCT02461160|BG011|Baseline|BA/FE Cohort 11 Group 3: C,A,B|Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1 followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2. Each period was separated out by a 6 to 14-day washout period.
11238083|NCT02461160|BG012|Baseline|ESSD Cohort 12: TAK-915 50 mg|TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
11238084|NCT02461160|BG013|Baseline|Total|Total of all reporting groups
11238085|NCT02461160|FG000|Participant Flow|SRD Cohorts Pooled Placebo|TAK-915 placebo-matching suspension, orally, once on Day 1.
11238086|NCT02461160|FG001|Participant Flow|SRD Cohort 1 TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1.
11238087|NCT02461160|FG002|Participant Flow|SRD Cohort 2: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1.
11238088|NCT02461160|FG003|Participant Flow|SRD Cohort 3: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1.
11238089|NCT02461160|FG004|Participant Flow|MRD Cohorts Pooled Placebo|TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.
11238090|NCT02461160|FG005|Participant Flow|MRD Cohort 5: TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.
11238091|NCT02461160|FG006|Participant Flow|MRD Cohort 6: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.
11238092|NCT02461160|FG007|Participant Flow|MRD Cohort 7: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.
11238093|NCT02461160|FG008|Participant Flow|DDI Cohort 8: TAK-915 + Midazolam 2 mg|Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).
11238094|NCT02461160|FG009|Participant Flow|BA/FE Cohort 9 Group 1: A,B,C|Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1, followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3. Each period was separated out by a 6 to 14-day washout period.
11238095|NCT02461160|FG010|Participant Flow|BA/FE Cohort 10 Group 2: B,C,A|Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1. Each period was separated out by a 6 to 14-day washout period.
11238096|NCT02461160|FG011|Participant Flow|BA/FE Cohort 11 Group 3: C,A,B|Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1 followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2. Each period was separated out by a 6 to 14-day washout period.
11238097|NCT02461160|FG012|Participant Flow|ESSD Cohort 12: TAK-915 50 mg|TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
11238098|NCT02461160|OG000|Outcome|SRD Cohorts Pooled Placebo|TAK-915 placebo-matching suspension, orally, once on Day 1.
11238099|NCT02461160|OG001|Outcome|SRD Cohort 1 TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1.
11238100|NCT02461160|OG002|Outcome|SRD Cohort 2: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1.
11238101|NCT02461160|OG003|Outcome|SRD Cohort 3: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1.
11238102|NCT02461160|OG004|Outcome|MRD Cohorts Pooled Placebo|TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.
11238103|NCT02461160|OG005|Outcome|MRD Cohort 5: TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.
11238104|NCT02461160|OG006|Outcome|MRD Cohort 6: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.
11238105|NCT02461160|OG007|Outcome|MRD Cohort 7: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.
11238106|NCT02461160|OG008|Outcome|DDI Cohort 8: Midazolam 2 mg|Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).
11238107|NCT02461160|OG009|Outcome|DDI Cohort 8: TAK-915 100 mg|TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.
10961997|NCT00864084|OG001|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
11238108|NCT02461160|OG010|Outcome|DDI Cohort 8: TAK-915 + Midazolam 2 mg|Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).
11238109|NCT02461160|OG011|Outcome|BA/FE Cohort Regimen A|TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.
11238110|NCT02461160|OG012|Outcome|BA/FE Cohort Regimen B|TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.
11238111|NCT02461160|OG013|Outcome|BA/FE Cohort Regimen C|TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.
11238112|NCT02461160|OG014|Outcome|ESSD Cohort 12: TAK-915 50 mg|TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
11238113|NCT02461160|OG011|Outcome|BA/FE Cohort Regimen A|TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of any period.
11238114|NCT02461160|OG000|Outcome|SRD Cohort 1 TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1.
11238115|NCT02461160|OG001|Outcome|SRD Cohort 2: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1.
11238116|NCT02461160|OG002|Outcome|SRD Cohort 3: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1.
11238117|NCT02461160|OG003|Outcome|SRD Cohort 4: TAK-915 200 mg|TAK-915 200 mg suspension, orally via syringe, once on Day 1.
11238118|NCT02461160|OG004|Outcome|MRD Cohort 5: TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.
11238119|NCT02461160|OG005|Outcome|MRD Cohort 6: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.
11238120|NCT02461160|OG006|Outcome|MRD Cohort 7: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.
11238121|NCT02461160|OG007|Outcome|ESSD Cohort 12: TAK-915 50 mg|TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
11238122|NCT02461160|OG000|Outcome|MRD Cohort 5: TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.
11238123|NCT02461160|OG001|Outcome|MRD Cohort 6: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.
11238124|NCT02461160|OG002|Outcome|MRD Cohort 7: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.
11238125|NCT02461160|OG000|Outcome|DDI Cohort 7: TAK-915 + Midazolam 2 mg|Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).
11238126|NCT02461160|OG004|Outcome|ESSD Cohort 12: TAK-915 50 mg|TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
11238127|NCT02461160|OG000|Outcome|BA/FE Cohort Regimen A|TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.
11238128|NCT02461160|OG001|Outcome|BA/FE Cohort Regimen B|TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.
11238129|NCT02461160|OG002|Outcome|BA/FE Cohort Regimen C|TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.
11238130|NCT02461160|EG000|Reported Event|SRD Cohorts Pooled Placebo|TAK-915 placebo-matching suspension, orally, once on Day 1.
11238131|NCT02461160|EG001|Reported Event|SRD Cohort 1 TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1.
11238132|NCT02461160|EG002|Reported Event|SRD Cohort 2: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1.
11238133|NCT02461160|EG003|Reported Event|SRD Cohort 3: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1.
11238134|NCT02461160|EG004|Reported Event|MRD Cohorts Pooled Placebo|TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.
11238135|NCT02461160|EG005|Reported Event|MRD Cohort 5: TAK-915 30 mg|TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.
11238136|NCT02461160|EG006|Reported Event|MRD Cohort 6: TAK-915 100 mg|TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.
11238137|NCT02461160|EG007|Reported Event|MRD Cohort 7: TAK-915 200 mg|TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.
11238138|NCT02461160|EG008|Reported Event|DDI Cohort 8: Midazolam 2 mg|Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).
11238139|NCT02461160|EG009|Reported Event|DDI Cohort 8: TAK-915 100 mg|TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.
11238140|NCT02461160|EG010|Reported Event|DDI Cohort 8: TAK-915 + Midazolam 2 mg|Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915)
11238141|NCT02461160|EG011|Reported Event|BA/FE Cohort Regimen A|TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.
11238142|NCT02461160|EG012|Reported Event|BA/FE Cohort Regimen B|TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.
11238143|NCT02461160|EG013|Reported Event|BA/FE Cohort Regimen C|TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.
11359157|NCT03212144|OG000|Outcome|High Intensity Interval Training - Aerobic Exercise|"Participants will engage in 4 training sessions per week over a 4-week period, with 24 hour rest-periods between each training day. Each session begins with a 3 min low intensity warm-up, and then participants exercise as rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the submaximal cardiopulmonary exercise testing. This 20 second period is followed by 40 seconds of low intensity exercise.~High Intensity Interval Training: Subjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks"
11359158|NCT03212144|OG001|Outcome|Peanut Consumption|"Regular daily caloric intake of each subject will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Participants will consume dry roasted, unsalted peanuts equivalent to approximately 10% of daily energy intake twice (total=20% total), which will range from 400kcal to 600 kcal, which corresponds to about 2.4 oz to 3.6 oz. Peanuts will replace protein and fat containing foods so that the daily caloric intake will not differ from participants' typical diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly.Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day.~Peanut Consumption: Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks."
11359159|NCT03212144|EG000|Reported Event|High Intensity Interval Training First Then Peanut Consumption|"High intensity interval training first then peanut consumption~High intensity interval training:~4 training sessions per week over a 4-week period, with 24hour rest-periods between each training day. Each session begins with a 3 min low intensity warm-up, and then participants exercise as rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the submaximal cardiopulmonary exercise testing. This 20 second period is followed by 40 seconds of low intensity exercise."
11359160|NCT03212144|EG001|Reported Event|Peanut Consumption First Then High Intensity Interval Training|"Peanut consumption first then high intensity interval Training~Peanut Consumption:~Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks.~Daily caloric intake will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Peanuts replaces protein and fat containing foods so that the daily caloric intake will not differ from diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day."
11359161|NCT03218163|BG000|Baseline|MEDI-551 Treatment Arm|"Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons.~MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV"
11359162|NCT03218163|FG000|Participant Flow|MEDI-551 Treatment Arm|"MEDI-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 graft-versus-host disease (GVHD), documentation of disease progression, or patient withdrawal for other reasons.~MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV"
11359163|NCT03218163|OG000|Outcome|MEDI-551 Treatment Arm|"Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons.~MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV"
11359164|NCT03218163|EG000|Reported Event|MEDI-551 Treatment Arm|"Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons.~MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV"
11359165|NCT03172520|BG000|Baseline|Facial Nerve Monitoring With APS Electrode|"The investigators will use the Facial Nerve Monitor along with the APS electrode during parotidectomy surgery.~APS electrode: The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.~Facial Nerve Monitor: The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete."
11186597|NCT02101060|OG000|Outcome|Exercise|"16-week progressive aerobic and resistance exercise training~exercise: 16-week progressive aerobic and resistance exercise training"
11186598|NCT02101060|OG001|Outcome|Control|usual care controls
11186599|NCT02101060|EG000|Reported Event|Exercise|"16-week progressive aerobic and resistance exercise training~exercise: 16-week progressive aerobic and resistance exercise training"
11186600|NCT02101060|EG001|Reported Event|Control|usual care controls
11186601|NCT02101112|BG000|Baseline|Apixaban, 10 mg (Whole Tablets)|This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
11186602|NCT02101112|FG000|Participant Flow|Treatment A Then Treatment B Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
11186603|NCT02101112|FG001|Participant Flow|Treatment A Then Treatment C Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
11186604|NCT02101112|FG002|Participant Flow|Treatment B Then Treatment C Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
11186605|NCT02101112|FG003|Participant Flow|Treatment B Then Treatment A Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
11186606|NCT02101112|FG004|Participant Flow|Treatment C Then Treatment A Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
11186607|NCT02101112|FG005|Participant Flow|Treatment C Then Treatment B Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
11186608|NCT02101112|OG000|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
11238144|NCT02461160|EG014|Reported Event|ESSD Cohort 12: TAK-915 50 mg|TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
11359166|NCT03172520|FG000|Participant Flow|Facial Nerve Monitoring With APS Electrode|"The investigators will use the Facial Nerve Monitor along with the automatic periodic stimulating (APS) electrode during parotidectomy surgery.~APS electrode: The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.~Facial Nerve Monitor: The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete."
11359167|NCT03172520|OG000|Outcome|Facial Nerve Monitoring With APS Electrode|"The investigators will use the Facial Nerve Monitor along with the APS electrode during parotidectomy surgery.~APS electrode: The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.~Facial Nerve Monitor: The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete."
11359168|NCT03172520|EG000|Reported Event|Facial Nerve Monitoring With APS Electrode|"The investigators will use the Facial Nerve Monitor along with the APS electrode during parotidectomy surgery.~APS electrode: The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.~Facial Nerve Monitor: The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete."
11359169|NCT03204539|BG000|Baseline|Alternative Treatment|"Half of the participants will be randomized to blinded individualized lot selection for ITI.~Wilate: Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques."
11359170|NCT03204539|BG001|Baseline|Standard Treatment|"The other half of the participants will receive random lot selection for ITI.~Wilate: Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques."
11359171|NCT03204539|BG002|Baseline|Total|Total of all reporting groups
11359172|NCT03204539|FG000|Participant Flow|Alternative Treatment|"Half of the participants will be randomized to blinded individualized lot selection for ITI.~Wilate: Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques."
11359173|NCT03204539|FG001|Participant Flow|Standard Treatment|"The other half of the participants will receive random lot selection for ITI.~Wilate: Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques."
11359174|NCT03204539|OG000|Outcome|Alternative Treatment|"Half of the participants will be randomized to blinded individualized lot selection for ITI.~Wilate: Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques."
11359175|NCT03204539|OG001|Outcome|Standard Treatment|"The other half of the participants will receive random lot selection for ITI.~Wilate: Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques."
11359176|NCT03204539|EG000|Reported Event|Alternative Treatment|"Half of the participants will be randomized to blinded individualized lot selection for ITI.~Wilate: Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques."
11359177|NCT03204539|EG001|Reported Event|Standard Treatment|"The other half of the participants will receive random lot selection for ITI.~Wilate: Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques."
11359178|NCT03206216|BG000|Baseline|Group A - Painful CIPN|"Participants with painful chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation.~Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation"
11359179|NCT03206216|BG001|Baseline|Group B - Painless CIPN|"Participants with painless chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation.~Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation"
11359180|NCT03206216|BG002|Baseline|Total|Total of all reporting groups
11359181|NCT03206216|FG000|Participant Flow|Group A - Painful CIPN|"Participants with painful chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation.~Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation"
11238145|NCT02461290|BG000|Baseline|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
11238146|NCT02461290|FG000|Participant Flow|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated follicular lymphoma (FL) received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included cyclophosphamide, vincristine, and prednisone (CVP); cyclophosphamide, doxorubin, vincristine, and predisone (CHOP); or fludarabine, cyclophosphamide, and mitoxantrone (FCM). Rituximab was administered as 375 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
11238147|NCT02461290|OG000|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
11238148|NCT02461290|EG000|Reported Event|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
11238149|NCT02461433|BG000|Baseline|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
11238150|NCT02461433|BG001|Baseline|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
11238151|NCT02461433|BG002|Baseline|Total|Total of all reporting groups
11238152|NCT02461433|FG000|Participant Flow|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
11238153|NCT02461433|FG001|Participant Flow|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
11238154|NCT02461433|OG000|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
11238155|NCT02461433|OG001|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
11238156|NCT02461433|EG000|Reported Event|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
11238157|NCT02461433|EG001|Reported Event|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
11238158|NCT02461563|BG000|Baseline|GT1 400 mg MK-1075|Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238159|NCT02461563|BG001|Baseline|GT1 MK-1075 600 mg|Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238160|NCT02461563|BG002|Baseline|GT3 400 mg MK-1075|Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238161|NCT02461563|BG003|Baseline|GT3 600 mg MK-1075|Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238162|NCT02461563|BG004|Baseline|Total|Total of all reporting groups
11238163|NCT02461563|FG000|Participant Flow|GT1 400 mg MK-1075|Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238164|NCT02461563|FG001|Participant Flow|GT1 MK-1075 600 mg|Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238165|NCT02461563|FG002|Participant Flow|GT3 400 mg MK-1075|Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238166|NCT02461563|FG003|Participant Flow|GT3 600 mg MK-1075|Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238167|NCT02461563|OG000|Outcome|GT1 400 mg MK-1075|Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238168|NCT02461563|OG001|Outcome|GT1 MK-1075 600 mg|Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238169|NCT02461563|OG002|Outcome|GT3 400 mg MK-1075|Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238170|NCT02461563|OG003|Outcome|GT3 600 mg MK-1075|Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238171|NCT02461563|OG000|Outcome|GT1 and GT3 Pooled 400 mg MK-1075|Fasted GT1 and GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238172|NCT02461563|OG001|Outcome|GT1 and GT3 Pooled MK-1075 600 mg|Fasted GT1 and GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238173|NCT02461563|EG000|Reported Event|GT1 Pre-treatment|GT1 participants were enrolled for 4 weeks prior to randomization and treatment.
11238174|NCT02461563|EG001|Reported Event|GT3 Pre-treatment|GT3 participants were enrolled for 4 weeks prior to randomization and treatment.
11186609|NCT02101112|OG001|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
11186610|NCT02101112|OG002|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
11186611|NCT02101112|OG000|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
11186612|NCT02101112|OG001|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
11186613|NCT02101112|EG000|Reported Event|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
11186614|NCT02101112|EG001|Reported Event|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
11186615|NCT02101112|EG002|Reported Event|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
11186616|NCT02101190|BG000|Baseline|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
11186617|NCT02101190|BG001|Baseline|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
11186618|NCT02101190|BG002|Baseline|Total|Total of all reporting groups
11186619|NCT02101190|FG000|Participant Flow|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
11186620|NCT02101190|FG001|Participant Flow|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
11186621|NCT02101190|OG000|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
10961998|NCT00864084|EG000|Reported Event|Study Participation|Participant data collection at baseline (pre-pulmonary rehabilitation), participation in an 8-week outpatient pulmonary rehabilitation program and data collection at follow-up (post-pulmonary rehabilitation).
11186622|NCT02101190|OG001|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
11186623|NCT02101190|EG000|Reported Event|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
11186624|NCT02101190|EG001|Reported Event|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
11186625|NCT02101281|BG000|Baseline|Group 1 - rhNGF 20 μg/mL|"(first planned dose): one drop (35 μL) corresponding to 0.70 μg of rhNGF was instilled into each eye twice a day (b.i.d.) every 12±2 h for a total daily dose of 2.8 μg (both eyes), for 28 consecutive days. Total dose was 78.4 μg/28 days.~rhNGF 20 µg/mL: 1 drop for each eye, twice daily for 28 day"
11186626|NCT02101281|BG001|Baseline|Group 2 - rhNGF 4 μg/mL|"after completion of Group 1 treatment, one drop (35 μL) corresponding to 0.14 μg of rhNGF was instilled into each eye b.i.d. every 12±2 h for a total daily dose of 0.56 μg, for 28 consecutive days. Total dose was 15.68 μg/28 days.~rhNGF 4 µg/mL: 1 drop each eye, twice daily for 28 day"
11186627|NCT02101281|BG002|Baseline|Total|Total of all reporting groups
11186628|NCT02101281|FG000|Participant Flow|Group 1 - rhNGF 20 μg/mL|"(first planned dose): one drop (35 μL) corresponding to 0.70 μg of rhNGF was instilled into each eye twice a day (b.i.d.) every 12±2 h for a total daily dose of 2.8 μg (both eyes), for 28 consecutive days. Total dose was 78.4 μg/28 days.~rhNGF 20 µg/mL: 1 drop for each eye, twice daily for 28 day"
11186629|NCT02101281|FG001|Participant Flow|Group 2 - rhNGF 4 μg/mL|"after completion of Group 1 treatment, one drop (35 μL) corresponding to 0.14 μg of rhNGF was instilled into each eye b.i.d. every 12±2 h for a total daily dose of 0.56 μg, for 28 consecutive days. Total dose was 15.68 μg/28 days.~rhNGF 4 µg/mL: 1 drop each eye, twice daily for 28 day"
11186630|NCT02101281|OG000|Outcome|SANDE Changes From Baseline With rhNGF 20 μg/mL|Mean (±SD) changes from baseline and the outcome of their comparison with baseline after treatment with rhNGF 20 μg/mL - Day 1, 8, 29, 56
11186631|NCT02101281|OG001|Outcome|SANDE Changes From Baseline With rhNGF 4 μg/mL|Mean (±SD) changes from baseline and the outcome of their comparison with baseline after treatment with rhNGF 4 μg/mL - Day 1, 8, 29, 56
11186632|NCT02101281|OG000|Outcome|Ocular Surface Staining With LG With rhNGF 20 μg/mL|Mean (±SD) changes from baseline and the outcome of their comparison with baseline after treatment with rhNGF 20 μg/mL - Day 1, 8, 29, 56
11186633|NCT02101281|OG001|Outcome|Ocular Surface Staining With LG With rhNGF 4 μg/mL|Mean (±SD) changes from baseline and the outcome of their comparison with baseline after treatment with rhNGF 20 μg/mL - Day 1, 8, 29, 56
11186634|NCT02101281|OG000|Outcome|Schirmer's Test Type I Changes From Baseline - rhNGF 20 μg/mL|Mean (±SD) changes from baseline and the outcome of their comparison with baseline after treatment with rhNGF 20 μg/mL - Day 1, 8, 29, 56
11186635|NCT02101281|OG001|Outcome|Schirmer's Test Type I Changes From Baseline - rhNGF 4 μg/mL|Mean (±SD) changes from baseline and the outcome of their comparison with baseline after treatment with rhNGF 4 μg/mL - Day 1, 8, 29, 56
11186636|NCT02101281|OG000|Outcome|Group 1 - rhNGF 20 μg/mL|"(first planned dose): one drop (35 μL) corresponding to 0.70 μg of rhNGF was instilled into each eye twice a day (b.i.d.) every 12±2 h for a total daily dose of 2.8 μg (both eyes), for 28 consecutive days. Total dose was 78.4 μg/28 days.~rhNGF 20 µg/mL: 1 drop for each eye, twice daily for 28 day"
11238175|NCT02461563|EG002|Reported Event|GT1 400 mg MK-1075|Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238176|NCT02461563|EG003|Reported Event|GT1 600 mg MK-1075|Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
11238177|NCT02461563|EG004|Reported Event|GT3 MK-1075 400 mg|Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days.
11238178|NCT02461563|EG005|Reported Event|GT3 600 mg MK-1075|Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days.
11238179|NCT02461563|EG006|Reported Event|GT1 Post-study|After treatment Day 7, GT1 participants were monitored for AEs up to Day 42.
11238180|NCT02461563|EG007|Reported Event|GT3 Post-study|After treatment Day 7, GT3 participants were monitored for AEs up to Day 42.
11238181|NCT02461589|BG000|Baseline|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238182|NCT02461589|BG001|Baseline|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238183|NCT02461589|BG002|Baseline|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238184|NCT02461589|BG003|Baseline|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238185|NCT02461589|BG004|Baseline|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238186|NCT02461589|BG005|Baseline|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238187|NCT02461589|BG006|Baseline|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238188|NCT02461589|BG007|Baseline|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238189|NCT02461589|BG008|Baseline|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238190|NCT02461589|BG009|Baseline|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
11238191|NCT02461589|BG010|Baseline|Total|Total of all reporting groups
11238192|NCT02461589|FG000|Participant Flow|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238193|NCT02461589|FG001|Participant Flow|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238194|NCT02461589|FG002|Participant Flow|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238195|NCT02461589|FG003|Participant Flow|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238196|NCT02461589|FG004|Participant Flow|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238197|NCT02461589|FG005|Participant Flow|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238198|NCT02461589|FG006|Participant Flow|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11186637|NCT02101281|OG001|Outcome|Group 2 - rhNGF 4 μg/mL|"after completion of Group 1 treatment, one drop (35 μL) corresponding to 0.14 μg of rhNGF was instilled into each eye b.i.d. every 12±2 h for a total daily dose of 0.56 μg, for 28 consecutive days. Total dose was 15.68 μg/28 days.~rhNGF 4 µg/mL: 1 drop each eye, twice daily for 28 day"
11186638|NCT02101281|EG000|Reported Event|Group 1 - rhNGF 20 μg/mL|"(first planned dose): one drop (35 μL) corresponding to 0.70 μg of rhNGF was instilled into each eye twice a day (b.i.d.) every 12±2 h for a total daily dose of 2.8 μg (both eyes), for 28 consecutive days. Total dose was 78.4 μg/28 days.~rhNGF 20 µg/mL: 1 drop for each eye, twice daily for 28 day"
11186639|NCT02101281|EG001|Reported Event|Group 2 - rhNGF 4 μg/mL|"after completion of Group 1 treatment, one drop (35 μL) corresponding to 0.14 μg of rhNGF was instilled into each eye b.i.d. every 12±2 h for a total daily dose of 0.56 μg, for 28 consecutive days. Total dose was 15.68 μg/28 days.~rhNGF 4 µg/mL: 1 drop each eye, twice daily for 28 day"
11186640|NCT02101294|BG000|Baseline|Interossei Lumbricals Neuro Interface|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
11186641|NCT02101294|FG000|Participant Flow|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.~Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
11186642|NCT02101294|OG000|Outcome|Length of Time Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
11186643|NCT02101294|OG000|Outcome|Measurement of Wrist Swelling Following Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the QWERTY keyboard.
11186644|NCT02101294|OG000|Outcome|Length of Time Typing With FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the FingerRelief keyboard prior to stopping, averaged across two typing sessions.
11186645|NCT02101294|OG000|Outcome|Measurement of Wrist Swelling Following FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the FingerRelief keyboard.
11186646|NCT02101294|EG000|Reported Event|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.~Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
11186647|NCT02101359|BG000|Baseline|T2380|T2380: Intracameral administration during surgery
11186648|NCT02101359|BG001|Baseline|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
11186649|NCT02101359|BG002|Baseline|Total|Total of all reporting groups
11186650|NCT02101359|FG000|Participant Flow|T2380|T2380: Intracameral administration during surgery
11186651|NCT02101359|FG001|Participant Flow|Reference Group|Mydriatics and anesthetics: Topical treatments used the day of surgery
11186652|NCT02101359|OG000|Outcome|T2380|T2380: Intracameral administration during surgery
11186653|NCT02101359|OG001|Outcome|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
11186654|NCT02101359|EG000|Reported Event|T2380|T2380: Intracameral administration during surgery
11186655|NCT02101359|EG001|Reported Event|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
11186656|NCT02101411|BG000|Baseline|Aspirin+Clopidogrel|aspirin 100mg qd+clopidogrel 75mg q...
11186657|NCT02101411|BG001|Baseline|Aspirin+Ticagrelor|aspirin100mg qd+ticagrelor 90mg bid
11186658|NCT02101411|BG002|Baseline|Aspirin+Clopidogrel+Cilostazol|aspirin 100mg qd+clopidogrel 75mg q...
11186659|NCT02101411|BG003|Baseline|Total|Total of all reporting groups
11186660|NCT02101411|FG000|Participant Flow|Aspirin+Clopidogrel|aspirin 100mg qd+clopidogrel 75mg qd
11186661|NCT02101411|FG001|Participant Flow|Aspirin+Ticagrelor|aspirin100mg qd+ticagrelor 90mg bid
11186662|NCT02101411|FG002|Participant Flow|Aspirin+Clopidogrel+Cilostazol|aspirin 100mg qd+clopidogrel 75mg qd+cilostazol 100mg bid
11186663|NCT02101411|OG000|Outcome|Aspirin+Clopidogrel|aspirin 100mg qd+clopidogrel 75mg qd
11186664|NCT02101411|OG001|Outcome|Aspirin+Ticagrelor|aspirin100mg qd+ticagrelor 90mg bid
11186665|NCT02101411|OG002|Outcome|Aspirin+Clopidogrel+Cilostazol|aspirin 100mg qd+clopidogrel 75mg qd+cilostazol 100mg bid
11186666|NCT02101411|EG000|Reported Event|Aspirin+Clopidogrel|aspirin 100mg qd+clopidogrel 75mg qd
11186667|NCT02101411|EG001|Reported Event|Aspirin+Ticagrelor|aspirin100mg qd+ticagrelor 90mg bid
11186668|NCT02101411|EG002|Reported Event|Aspirin+Clopidogrel+Cilostazol|aspirin 100mg qd+clopidogrel 75mg qd+cilostazol 100mg bid
11186669|NCT02101437|BG000|Baseline|Control|no stent or anti-platelet drugs
11186670|NCT02101437|BG001|Baseline|Clopidogrel|under clopidogrel treatment
11186671|NCT02101437|BG002|Baseline|Ticagrelor|under ticagrelor treatment
11186672|NCT02101437|BG003|Baseline|Clopidogrel+Cilostazol|under clopidogrel and cilostazol treatment
11186673|NCT02101437|BG004|Baseline|Total|Total of all reporting groups
11186674|NCT02101437|FG000|Participant Flow|Control|no stent or anti-platelet drugs
11186675|NCT02101437|FG001|Participant Flow|Clopidogrel|under clopidogrel treatment
11186676|NCT02101437|FG002|Participant Flow|Ticagrelor|under ticagrelor treatment
11186677|NCT02101437|FG003|Participant Flow|Clopidogrel+Cilostazol|under clopidogrel and cilostazol treatment
11186678|NCT02101437|OG000|Outcome|Control|no stent or anti-platelet drugs
11186679|NCT02101437|OG001|Outcome|Clopidogrel|under clopidogrel treatment
11186680|NCT02101437|OG002|Outcome|Ticagrelor|under ticagrelor treatment
11186681|NCT02101437|OG003|Outcome|Clopidogrel+Cilostazol|under clopidogrel and cilostazol treatment
11186682|NCT02101437|EG000|Reported Event|Control|no stent or anti-platelet drugs
11186683|NCT02101437|EG001|Reported Event|Clopidogrel|under clopidogrel treatment
11186684|NCT02101437|EG002|Reported Event|Ticagrelor|under ticagrelor treatment
11186685|NCT02101437|EG003|Reported Event|Clopidogrel+Cilostazol|under clopidogrel and cilostazol treatment
11186686|NCT02101515|BG000|Baseline|Usual Labor|"Immediate delivery after 3 hours with epidural or 2 hours without epidural~Length of Second Stage: The experimental group will have one additional hour in the second stage of labor~n = 37"
11186687|NCT02101515|BG001|Baseline|Extended|"Immediate delivery after 4 hours with an epidural or 3 hours without an epidural~Intervention: one additional hour for the second stage of labor~Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural.~Length of Second Stage: The experimental group will have one additional hour in the second stage of labor~n = 41"
11186688|NCT02101515|BG002|Baseline|Total|Total of all reporting groups
11186689|NCT02101515|FG000|Participant Flow|Usual Labor|"Immediate delivery after 3 hours with epidural or 2 hours without epidural~Length of Second Stage: The experimental group will have one additional hour in the second stage of labor~n = 37"
11186690|NCT02101515|FG001|Participant Flow|Extended|"Immediate delivery after 4 hours with an epidural or 3 hours without an epidural~Intervention: one additional hour for the second stage of labor~Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural.~Length of Second Stage: The experimental group will have one additional hour in the second stage of labor~n = 41"
11186691|NCT02101515|OG000|Outcome|Usual Labor|"Immediate delivery after 3 hours with epidural or 2 hours without epidural~Length of Second Stage: The experimental group will have one additional hour in the second stage of labor"
11186692|NCT02101515|OG001|Outcome|Extended|"Immediate delivery after 4 hours with an epidural or 3 hours without an epidural~Intervention: one additional hour for the second stage of labor~Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural.~Length of Second Stage: The experimental group will have one additional hour in the second stage of labor"
11186693|NCT02101515|EG000|Reported Event|Usual Labor|"Immediate delivery after 3 hours with epidural or 2 hours without epidural~Length of Second Stage: The experimental group will have one additional hour in the second stage of labor"
11186694|NCT02101515|EG001|Reported Event|Extended|"Immediate delivery after 4 hours with an epidural or 3 hours without an epidural~Intervention: one additional hour for the second stage of labor~Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural.~Length of Second Stage: The experimental group will have one additional hour in the second stage of labor"
11186695|NCT02101554|BG000|Baseline|PF-06412528 <=20 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to less than or equal to (<=) 20 milligram (mg) daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 <=20 mg oral daily dose up to a maximum of additional 6 weeks.
11186696|NCT02101554|BG001|Baseline|PF-06412528 >20-40 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to greater than (>) 20 mg to 40 mg daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 >20 mg to 40 mg oral daily dose up to a maximum of additional 6 weeks.
11186697|NCT02101554|BG002|Baseline|PF-06412528 >40-80 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to >40 mg to 80 mg daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 >40 mg to 80 mg oral daily dose up to a maximum of additional 6 weeks.
11186698|NCT02101554|BG003|Baseline|Total|Total of all reporting groups
11186699|NCT02101554|FG000|Participant Flow|PF-06412528 <=20 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to less than or equal to (<=) 20 milligram (mg) daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 <=20 mg oral daily dose up to a maximum of additional 6 weeks.
11186700|NCT02101554|FG001|Participant Flow|PF-06412528 >20-40 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to greater than (>) 20 mg to 40 mg daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 >20 mg to 40 mg oral daily dose up to a maximum of additional 6 weeks.
11359182|NCT03206216|FG001|Participant Flow|Group B - Painless CIPN|"Participants with painless chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation.~Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation"
11359183|NCT03206216|OG000|Outcome|Group A - Painful CIPN|"Participants with painful chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation.~Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation"
11359184|NCT03206216|OG001|Outcome|Group B - Painless CIPN|"Participants with painless chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation.~Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation"
11359185|NCT03206216|EG000|Reported Event|Group A - Painful CIPN|"Participants with painful chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation.~Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation"
11359186|NCT03206216|EG001|Reported Event|Group B - Painless CIPN|"Participants with painless chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation.~Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation"
11359187|NCT03195660|BG000|Baseline|ASV Therapy|"ASV Therapy~ASV Therapy: AirCurve 10 ASV device set up in AutoSet mode"
11359188|NCT03195660|FG000|Participant Flow|ASV Therapy|"ASV Therapy~ASV Therapy: AirCurve 10 ASV device set up in AutoSet mode"
11359189|NCT03195660|OG000|Outcome|ASV Therapy|"ASV Therapy~ASV Therapy: AirCurve 10 ASV device set up in AutoSet mode"
11359190|NCT03195660|EG000|Reported Event|ASV Therapy|"ASV Therapy~ASV Therapy: AirCurve 10 ASV device set up in AutoSet mode"
11359191|NCT03195465|BG000|Baseline|Cacao Group|"1 group of subjects will all receive the high antioxidant cacao bars. 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m.~Dark Chocolate: Dark Chocolate bars with 70% cacao and 30% organic cane sugar where 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m. daily for four weeks."
11359192|NCT03195465|FG000|Participant Flow|Cacao Group|"1 group of subjects will all receive the high antioxidant cacao bars. 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m.~Dark Chocolate: Dark Chocolate bars with 70% cacao and 30% organic cane sugar where 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m. daily for four weeks."
11359193|NCT03195465|OG000|Outcome|Cacao Group|"1 group of subjects will all receive the high antioxidant cacao bars. 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m.~Dark Chocolate: Dark Chocolate bars with 70% cacao and 30% organic cane sugar where 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m. daily for four weeks."
11359194|NCT03195465|EG000|Reported Event|Cacao Group|"1 group of subjects will all receive the high antioxidant cacao bars. 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m.~Dark Chocolate: Dark Chocolate bars with 70% cacao and 30% organic cane sugar where 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m. daily for four weeks."
11359195|NCT03166618|BG000|Baseline|VOLUMA® XC Treatment|Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.
11359196|NCT03166618|BG001|Baseline|Control_No Treatment|No treatment is administered.
11359197|NCT03166618|BG002|Baseline|Total|Total of all reporting groups
11359198|NCT03166618|FG000|Participant Flow|VOLUMA® XC Treatment|Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.
11359199|NCT03166618|FG001|Participant Flow|Control_No Treatment|No treatment is administered.
11359200|NCT03166618|OG000|Outcome|VOLUMA® XC Treatment|Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.
11359201|NCT03166618|OG001|Outcome|Control_No Treatment|No treatment is administered.
11359202|NCT03166618|EG000|Reported Event|VOLUMA® XC Treatment|Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.
11359203|NCT03166618|EG001|Reported Event|Control_No Treatment|No treatment is administered.
11359204|NCT03169530|BG000|Baseline|Alcohol|"One standard serving of alcohol (~15 gm) daily~Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years"
11359205|NCT03169530|BG001|Baseline|Abstention|Abstention from alcohol
11359206|NCT03169530|BG002|Baseline|Total|Total of all reporting groups
11359207|NCT03169530|FG000|Participant Flow|Alcohol|"One standard serving of alcohol (~15 gm) daily~Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years"
11359208|NCT03169530|FG001|Participant Flow|Abstention|Abstention from alcohol
10961999|NCT00864097|BG000|Baseline|Placebo + Diclofenac|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 milligram (mg) slow release tablet orally twice daily up to Week 32.
11359209|NCT03169530|OG000|Outcome|Alcohol|"One standard serving of alcohol (~15 gm) daily~Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years"
11359210|NCT03169530|OG001|Outcome|Abstention|Abstention from alcohol
11359211|NCT03169530|EG000|Reported Event|Alcohol|"One standard serving of alcohol (~15 gm) daily~Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years"
11359212|NCT03169530|EG001|Reported Event|Abstention|Abstention from alcohol
11359213|NCT03189433|BG000|Baseline|Ryanodex + Standard of Care|"Ryanodex (dantrolene sodium) 50 mg/mL suspension to be administered as a rapid IV push of 2.5 mg/kg, added to Standard of Care (SOC). SOC is defined as efficient body cooling by physical methods and supportive measures [ice packs, evaporative cooling(application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities]. Administer a single dose of Ryanodex. If a subject does not show an adequate clinical response within 10 - 30 minutes post-dose, a second IV bolus dose of 2.5 mg/kg may be administered.~Ryanodex (dantrolene sodium) for injectable suspension: Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be administered as a rapid IV push of 2.5 mg/mL."
11359214|NCT03189433|BG001|Baseline|Standard of Care Only (SOC)|Standard of Care is defined as efficient body cooling by physical methods and supportive methods and supportive measures[ice packs, evaporative cooling (application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities].
11359215|NCT03189433|BG002|Baseline|Total|Total of all reporting groups
11359216|NCT03189433|FG000|Participant Flow|Ryanodex + Standard of Care|"Ryanodex (dantrolene sodium) 50 mg/mL suspension to be administered as a rapid IV push of 2.5 mg/kg, added to Standard of Care (SOC). SOC is defined as efficient body cooling by physical methods and supportive measures [ice packs, evaporative cooling(application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities]. Administer a single dose of Ryanodex. If a subject does not show an adequate clinical response within 10 - 30 minutes post-dose, a second IV bolus dose of 2.5 mg/kg may be administered.~Ryanodex (dantrolene sodium) for injectable suspension: Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be administered as a rapid IV push of 2.5 mg/mL."
11359217|NCT03189433|FG001|Participant Flow|Standard of Care Only (SOC)|Standard of Care is defined as efficient body cooling by physical methods and supportive methods and supportive measures[ice packs, evaporative cooling (application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities].
11359218|NCT03189433|OG000|Outcome|Ryanodex + Standard of Care|"Ryanodex (dantrolene sodium) 50 mg/mL suspension to be administered as a rapid IV push of 2.5 mg/kg, added to Standard of Care (SOC). SOC is defined as efficient body cooling by physical methods and supportive measures [ice packs, evaporative cooling(application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities]. Administer a single dose of Ryanodex. If a subject does not show an adequate clinical response within 10 - 30 minutes post-dose, a second IV bolus dose of 2.5 mg/kg may be administered.~Ryanodex (dantrolene sodium) for injectable suspension: Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be administered as a rapid IV push of 2.5 mg/mL."
11359219|NCT03189433|OG001|Outcome|Standard of Care Only (SOC)|Standard of Care is defined as efficient body cooling by physical methods and supportive methods and supportive measures[ice packs, evaporative cooling (application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities].
11359220|NCT03189433|EG000|Reported Event|Ryanodex + Standard of Care|"Ryanodex (dantrolene sodium) 50 mg/mL suspension to be administered as a rapid IV push of 2.5 mg/kg, added to Standard of Care (SOC). SOC is defined as efficient body cooling by physical methods and supportive measures [ice packs, evaporative cooling(application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities]. Administer a single dose of Ryanodex. If a subject does not show an adequate clinical response within 10 - 30 minutes post-dose, a second IV bolus dose of 2.5 mg/kg may be administered.~Ryanodex (dantrolene sodium) for injectable suspension: Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be administered as a rapid IV push of 2.5 mg/mL."
11359221|NCT03189433|EG001|Reported Event|Standard of Care Only (SOC)|Standard of Care is defined as efficient body cooling by physical methods and supportive methods and supportive measures[ice packs, evaporative cooling (application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities].
11359222|NCT03151226|BG000|Baseline|Capnography Monitoring|"single arm, all subjects receiving duramorph will receive capnography monitoring~Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery"
11359223|NCT03151226|FG000|Participant Flow|Capnography Monitoring|"single arm, all subjects receiving duramorph will receive capnography monitoring~Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery"
11359224|NCT03151226|OG000|Outcome|Capnography Monitoring|"single arm, all subjects receiving duramorph will receive capnography monitoring~Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery"
11359225|NCT03151226|EG000|Reported Event|Capnography Monitoring|"single arm, all subjects receiving duramorph will receive capnography monitoring~Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery"
11359226|NCT03165747|BG000|Baseline|VSL#3|Participants randomized to receive two sachets of the VSL#3 probiotic, taken orally daily in a single administration.
10962000|NCT00864097|BG001|Baseline|Tanezumab 2.5 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
11359227|NCT03165747|BG001|Baseline|Placebo|Participants randomized to receive two placebo sachets, taken orally daily in a single administration.
11359228|NCT03165747|BG002|Baseline|Total|Total of all reporting groups
11359229|NCT03165747|FG000|Participant Flow|VSL#3|Participants randomized to receive two sachets of the VSL#3 probiotic, taken orally daily in a single administration.
11359230|NCT03165747|FG001|Participant Flow|Placebo|Participants randomized to receive two placebo sachets, taken orally daily in a single administration.
11359231|NCT03165747|OG000|Outcome|VSL#3|Participants randomized to receive two sachets of the VSL#3 probiotic, taken orally daily in a single administration.
11359232|NCT03165747|OG001|Outcome|Placebo|Participants randomized to receive two placebo sachets, taken orally daily in a single administration.
11359233|NCT03165747|EG000|Reported Event|VSL#3|Participants randomized to receive two sachets of the VSL#3 probiotic, taken orally daily in a single administration.
11359234|NCT03165747|EG001|Reported Event|Placebo|Participants randomized to receive two placebo sachets, taken orally daily in a single administration.
11359235|NCT03168906|BG000|Baseline|NEOD001|"Study Drug given IV every 28 days at 24mg/kg~NEOD001: NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates"
11359236|NCT03168906|BG001|Baseline|Placebo|"Placebo~Placebo: Saline bag"
11359237|NCT03168906|BG002|Baseline|Total|Total of all reporting groups
11359238|NCT03168906|FG000|Participant Flow|NEOD001|"Study Drug given IV every 28 days at 24mg/kg~NEOD001: NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates"
11359239|NCT03168906|FG001|Participant Flow|Placebo|"Placebo~Placebo: Saline bag"
11359240|NCT03168906|OG000|Outcome|NEOD001|"Study Drug given IV every 28 days at 24mg/kg~NEOD001: NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates"
11359241|NCT03168906|OG001|Outcome|Placebo|"Placebo~Placebo: Saline bag"
11359242|NCT03168906|OG001|Outcome|Placebo|Placebo
10962001|NCT00864097|BG002|Baseline|Tanezumab 5 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
11359243|NCT03168906|EG000|Reported Event|NEOD001|"Study Drug given IV every 28 days at 24mg/kg~NEOD001: NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates"
11359244|NCT03168906|EG001|Reported Event|Placebo|"Placebo~Placebo: Saline bag"
11359245|NCT03178201|BG000|Baseline|TGR-1202|"Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.~TGR-1202: Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days."
11359246|NCT03178201|FG000|Participant Flow|TGR-1202|"Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.~TGR-1202: Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days."
11359247|NCT03178201|OG000|Outcome|TGR-1202|"Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.~TGR-1202: Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days."
11359248|NCT03178201|EG000|Reported Event|TGR-1202|"Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.~TGR-1202: Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days."
11359249|NCT03172026|BG000|Baseline|Maraviroc + Augmented Rehabilitation|Maraviroc 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
11359250|NCT03172026|BG001|Baseline|Placebo + Augmented Rehabilitation|Placebo 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
11359251|NCT03172026|BG002|Baseline|Total|Total of all reporting groups
11359252|NCT03172026|FG000|Participant Flow|Maraviroc + Augmented Rehabilitation|Maraviroc 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
11359253|NCT03172026|FG001|Participant Flow|Placebo + Augmented Rehabilitation|Placebo 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
11359254|NCT03172026|OG000|Outcome|Maraviroc + Augmented Rehabilitation|Maraviroc 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
11359255|NCT03172026|OG001|Outcome|Placebo + Augmented Rehabilitation|Placebo 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
11359256|NCT03172026|OG001|Outcome|Placebo + Augmented Rehabilitation|Placebo 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation
11359257|NCT03172026|EG000|Reported Event|Maraviroc + Augmented Rehabilitation|Maraviroc 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
11359258|NCT03172026|EG001|Reported Event|Placebo + Augmented Rehabilitation|Placebo 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
11359259|NCT03152526|BG000|Baseline|CD3-/CD19- NK Cells Followed by IL-2|After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
11359260|NCT03152526|BG001|Baseline|CD3-/CD56+ NK Cells Followed by IL-2|After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
11359261|NCT03152526|BG002|Baseline|Total|Total of all reporting groups
11359262|NCT03152526|FG000|Participant Flow|CD3-/CD19- NK Cells Followed by IL-2|After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
11186701|NCT02101554|FG002|Participant Flow|PF-06412528 >40-80 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to >40 mg to 80 mg daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 >40 mg to 80 mg oral daily dose up to a maximum of additional 6 weeks.
11186702|NCT02101554|OG000|Outcome|PF-06412528 <=20 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to less than or equal to (<=) 20 milligram (mg) daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 <=20 mg oral daily dose up to a maximum of additional 6 weeks.
11186703|NCT02101554|OG001|Outcome|PF-06412528 >20-40 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to greater than (>) 20 mg to 40 mg daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 >20 mg to 40 mg oral daily dose up to a maximum of additional 6 weeks.
11186704|NCT02101554|OG002|Outcome|PF-06412528 >40-80 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to >40 mg to 80 mg daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 >40 mg to 80 mg oral daily dose up to a maximum of additional 6 weeks.
11186705|NCT02101554|EG000|Reported Event|PF-06412528 <=20 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to less than or equal to (<=) 20 milligram (mg) daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 <=20 mg oral daily dose up to a maximum of additional 6 weeks.
11186706|NCT02101554|EG001|Reported Event|PF-06412528 >20-40 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to greater than (>) 20 mg to 40 mg daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 >20 mg to 40 mg oral daily dose up to a maximum of additional 6 weeks.
11186707|NCT02101554|EG002|Reported Event|PF-06412528 >40-80 mg|Participants were converted from their pre-study standard of care opioid analgesic to PF-06412528; PF-06412528 oral dose was titrated and stabilized to >40 mg to 80 mg daily, up to a maximum of 4 weeks. Participants continued to receive stabilized PF-06412528 >40 mg to 80 mg oral daily dose up to a maximum of additional 6 weeks.
11186708|NCT02101918|BG000|Baseline|Aflibercept 6 mg /kg IV|Aflibercept 6 mg /kg IV every 3 weeks.
11186709|NCT02101918|FG000|Participant Flow|Aflibercept 6 mg /kg IV|Aflibercept 6 mg /kg IV every 3 weeks.
11186710|NCT02101918|OG000|Outcome|Aflibercept 6 mg /kg IV|Aflibercept 6 mg /kg IV every 3 weeks.
11186711|NCT02101918|EG000|Reported Event|Aflibercept 6 mg /kg IV|Aflibercept 6 mg /kg IV every 3 weeks.
11186712|NCT02101983|BG000|Baseline|Outpatient HiDAC Consolidation|"Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle.~Cytosine Arabinoside"
11186713|NCT02101983|BG001|Baseline|Quality of Life Comparison Group|"Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.~Cytosine Arabinoside"
11186714|NCT02101983|BG002|Baseline|Total|Total of all reporting groups
11186715|NCT02101983|FG000|Participant Flow|Outpatient HiDAC Consolidation|"Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle.~Cytosine Arabinoside"
11186716|NCT02101983|FG001|Participant Flow|Quality of Life Comparison Group|"Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.~Cytosine Arabinoside"
11186717|NCT02101983|OG000|Outcome|Outpatient HiDAC Consolidation|"Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle.~Cytosine Arabinoside"
11186718|NCT02101983|OG001|Outcome|Quality of Life Comparison Group|"Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.~Cytosine Arabinoside"
11186719|NCT02101983|EG000|Reported Event|Outpatient HiDAC Consolidation|"Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle.~Cytosine Arabinoside"
11186720|NCT02101983|EG001|Reported Event|Quality of Life Comparison Group|"Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.~Cytosine Arabinoside"
11186721|NCT02102100|BG000|Baseline|Menthol-Preferring Smokers|Menthol smokers randomized to a test session order and received control menthol (0.0% + tobacco flavor), low menthol (0.5% + tobacco flavor), and high menthol (3.2% + tobacco flavor) by standardized inhalation from an e-cigarette just prior to each nicotine infusion (a single menthol condition for each test session). Within each test session, all three IV nicotine conditions were tested, 1 hour apart, by delivering saline, nicotine at 0.25 mg nicotine/70 kg and nicotine at 0.5 mg nicotine/70 kg, in a random order, just after last inhalation. For each participant, the randomized nicotine infusion sequence was fixed across the three test sessions, each performed at least 24 hours apart.
11186722|NCT02102100|BG001|Baseline|Non-Menthol-Preferring Smokers|Non-menthol smokers randomized to a test session order and received control menthol (0.0% + tobacco flavor), low menthol (0.5% + tobacco flavor), and high menthol (3.2% + tobacco flavor) by standardized inhalation from an e-cigarette just prior to each nicotine infusion (a single menthol condition for each test session). Within each test session, all three IV nicotine conditions were tested, 1 hour apart, by delivering saline, nicotine at 0.25 mg nicotine/70 kg and nicotine at 0.5 mg nicotine/70 kg, in a random order, just after last inhalation. For each participant, the randomized nicotine infusion sequence was fixed across the three test sessions, each performed at least 24 hours apart.
11238199|NCT02461589|FG007|Participant Flow|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238200|NCT02461589|FG008|Participant Flow|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238201|NCT02461589|FG009|Participant Flow|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
11238202|NCT02461589|OG000|Outcome|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238203|NCT02461589|OG001|Outcome|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238204|NCT02461589|OG002|Outcome|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238205|NCT02461589|OG003|Outcome|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238206|NCT02461589|OG004|Outcome|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238207|NCT02461589|OG005|Outcome|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238208|NCT02461589|OG006|Outcome|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238209|NCT02461589|OG007|Outcome|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238210|NCT02461589|OG008|Outcome|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238211|NCT02461589|OG009|Outcome|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
11238212|NCT02461589|EG000|Reported Event|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238213|NCT02461589|EG001|Reported Event|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238214|NCT02461589|EG002|Reported Event|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238215|NCT02461589|EG003|Reported Event|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238216|NCT02461589|EG004|Reported Event|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11186723|NCT02102100|BG002|Baseline|Total|Total of all reporting groups
11186724|NCT02102100|FG000|Participant Flow|Menthol-Preferring Smokers|Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25mg and 0.5mg/70kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.
11186725|NCT02102100|FG001|Participant Flow|Non-Methol Preferring Smokers|Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25mg and 0.5mg/70kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.
11186726|NCT02102100|OG000|Outcome|Menthol-Preferring Smokers|"Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.~nicotine: In each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject.~menthol: In each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0"
11186727|NCT02102100|OG001|Outcome|Non-Menthol Preferring Smokers|"Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.~nicotine: In each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject.~menthol: In each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0"
11186728|NCT02102100|EG000|Reported Event|Menthol-Preferring Smokers|Each subject in this arm received a random sequence of 3 different inhaled menthol conditions (3.2% menthol, 0.5% menthol and tobacco-flavor only (0.0% menthol)) across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition.
11186729|NCT02102100|EG001|Reported Event|Non-Menthol Preferring Smokers|Each subject in this arm received a random sequence of 3 different inhaled menthol conditions (3.2% menthol, 0.5% menthol and tobacco-flavor only (0.0% menthol)) across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition.
11186730|NCT02102204|BG000|Baseline|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
11186731|NCT02102204|FG000|Participant Flow|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
11186732|NCT02102204|OG000|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
11186733|NCT02102204|EG000|Reported Event|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
11186734|NCT02102230|BG000|Baseline|CBT-I|"Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)~Cognitive Behavioral Therapy for Insomnia (CBT-I): This is a group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains."
11186735|NCT02102230|BG001|Baseline|CBT-I-MA|"Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)~Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA): This is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it, along with links to web-based psychoeducational materials, easily accessible to users."
11186736|NCT02102230|BG002|Baseline|Placebo|"Desensitization Treatment for Insomnia (DTI)~Desensitization Treatment for Insomnia: This is a group-delivered version of the sham sleep improvement treatment developed by Edinger which purports to desensitize the patient to the various aspects of the sleep experience which are presented as distressing."
11186737|NCT02102230|BG003|Baseline|Total|Total of all reporting groups
11186738|NCT02102230|FG000|Participant Flow|CBT-I|"Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)~Cognitive Behavioral Therapy for Insomnia (CBT-I): This is a group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains."
11186739|NCT02102230|FG001|Participant Flow|CBT-I-MA|"Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)~Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA): This is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/behaviors, generation of sleep prescription, iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it easily accessible to users. The app also provides plots of bed times, wake times, and sleep efficiency over time."
11186740|NCT02102230|FG002|Participant Flow|Placebo Control (PC)|"Desensitization Treatment for Insomnia (DTI)~Desensitization Treatment for Insomnia: This is a group-delivered version of the sham sleep improvement treatment developed by Edinger which purports to desensitize the patient to the various aspects of the sleep experience which are presented as distressing."
11186741|NCT02102230|OG000|Outcome|CBT-I|"Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)~Cognitive Behavioral Therapy for Insomnia (CBT-I): This is a group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains."
11186742|NCT02102230|OG001|Outcome|CBT-I-MA|"Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)~Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA): This is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it, along with links to web-based psychoeducational materials, easily accessible to users."
11186743|NCT02102230|OG002|Outcome|Placebo|"Desensitization Treatment for Insomnia (DTI)~Desensitization Treatment for Insomnia: This is a group-delivered version of the sham sleep improvement treatment developed by Edinger which purports to desensitize the patient to the various aspects of the sleep experience which are presented as distressing."
11186744|NCT02102230|OG001|Outcome|CBT-I-MA|"Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)~Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA): This is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/behaviors, generation of sleep prescription, iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it easily accessible to users. The app also provides plots of bed times, wake times, and sleep efficiency over time."
11186745|NCT02102230|EG000|Reported Event|CBT-I|"Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)~Cognitive Behavioral Therapy for Insomnia (CBT-I): This is a group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains."
11238217|NCT02461589|EG005|Reported Event|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238218|NCT02461589|EG006|Reported Event|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238219|NCT02461589|EG007|Reported Event|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238220|NCT02461589|EG008|Reported Event|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
11238221|NCT02461589|EG009|Reported Event|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
11238222|NCT02461628|BG000|Baseline|Malaria RDT & Conditional Voucher|"In the intervention arm, trained community health volunteers (CHVs) will offer eligible household members a free malaria rapid diagnostic test (RDT) and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test.~Malaria RDT & conditional voucher for ACT from retail sector: Trained community health volunteers will offer eligible household members free malaria rapid diagnostic tests and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test"
11238223|NCT02461628|BG001|Baseline|Comparison Arm|Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
11238224|NCT02461628|BG002|Baseline|Total|Total of all reporting groups
11238225|NCT02461628|FG000|Participant Flow|Malaria RDT & Conditional Voucher|"In the intervention arm, trained community health volunteers (CHVs) will offer eligible household members a free malaria rapid diagnostic test (RDT) and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test.~Malaria RDT & conditional voucher for ACT from retail sector: Trained community health volunteers will offer eligible household members free malaria rapid diagnostic tests and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test"
11238226|NCT02461628|FG001|Participant Flow|Comparison Arm|Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
11238227|NCT02461628|OG000|Outcome|Malaria RDT & Conditional Voucher|"In the intervention arm, trained community health volunteers (CHVs) will offer eligible household members a free malaria rapid diagnostic test (RDT) and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test.~Malaria RDT & conditional voucher for ACT from retail sector: Trained community health volunteers will offer eligible household members free malaria rapid diagnostic tests and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test"
11238228|NCT02461628|OG001|Outcome|Comparison Arm|Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
11238229|NCT02461628|EG000|Reported Event|Malaria RDT & Conditional Voucher|"In the intervention arm, trained community health volunteers (CHVs) will offer eligible household members a free malaria rapid diagnostic test (RDT) and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test.~Malaria RDT & conditional voucher for ACT from retail sector: Trained community health volunteers will offer eligible household members free malaria rapid diagnostic tests and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test"
11238230|NCT02461628|EG001|Reported Event|Comparison Arm|Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
11238231|NCT02461693|BG000|Baseline|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
11238232|NCT02461693|BG001|Baseline|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
11238233|NCT02461693|BG002|Baseline|Total|Total of all reporting groups
11238234|NCT02461693|FG000|Participant Flow|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
11238235|NCT02461693|FG001|Participant Flow|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
11238236|NCT02461693|OG000|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
11238237|NCT02461693|OG001|Outcome|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
11238238|NCT02461693|EG000|Reported Event|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
11238239|NCT02461693|EG001|Reported Event|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
11238240|NCT02461745|BG000|Baseline|Genotype 1a|Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
11238241|NCT02461745|BG001|Baseline|Genotype 1b|Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
11238242|NCT02461745|BG002|Baseline|Total|Total of all reporting groups
11238243|NCT02461745|FG000|Participant Flow|Genotype 1a|Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
11238244|NCT02461745|FG001|Participant Flow|Genotype 1b|Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
11238245|NCT02461745|OG000|Outcome|Genotype 1a|Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
11238246|NCT02461745|OG001|Outcome|Genotype 1b|Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
11238247|NCT02461745|OG000|Outcome|Genotype 1a|Study participants with chronic Hepatitis C Genotype 1A receiving VIEKIRA PAK and Ribavirin for 12 weeks.
11238248|NCT02461745|OG001|Outcome|Genotype 1b|Study participants with chronic Hepatitis C Genotype 1B receiving VIEKIRA PAK for 12 weeks.
11238249|NCT02461745|EG000|Reported Event|Genotype 1a|Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
11238250|NCT02461745|EG001|Reported Event|Genotype 1b|Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
11238251|NCT02461758|BG000|Baseline|Control Group|A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
11238252|NCT02461758|BG001|Baseline|Vedolizumab Group|A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
11238253|NCT02461758|BG002|Baseline|High Dose Influenza Vaccine (HDIV)|"This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238254|NCT02461758|BG003|Baseline|Standard Dose Influenza Vaccine (SDIV)|"This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238255|NCT02461758|BG004|Baseline|Total|Total of all reporting groups
11238256|NCT02461758|FG000|Participant Flow|Control Group|A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
11238257|NCT02461758|FG001|Participant Flow|Vedolizumab Group|A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
11238258|NCT02461758|FG002|Participant Flow|High Dose Influenza Vaccine (HDIV)|"This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238259|NCT02461758|FG003|Participant Flow|Standard Dose Influenza Vaccine (SDIV)|"This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238260|NCT02461758|OG000|Outcome|High Dose of Influenza Vaccine (HDIV) Group|"This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238261|NCT02461758|OG001|Outcome|Standard Dose Influenza Vaccine (SDIV) Group|"This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238262|NCT02461758|OG002|Outcome|Vedolizumab Group|A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
11238263|NCT02461758|OG003|Outcome|Control Group|A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
11238264|NCT02461758|OG000|Outcome|Standard Dose Influenza Vaccine (SDIV) Group|"This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238265|NCT02461758|OG001|Outcome|High Dose of Influenza Vaccine(HDIV) Group|"This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238266|NCT02461758|OG003|Outcome|Contorl Group|A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
11238267|NCT02461758|OG000|Outcome|Standard Dose Influenza Vaccine (SDIV) Group|"This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.~."
11238268|NCT02461758|OG002|Outcome|Vedolizumab Group|A group of 20 patients who are currently on Vedolizumab. All individuals in this group will receive SDIV
11238269|NCT02461758|EG000|Reported Event|High Dose Influenza Vaccine (HDIV)|"This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238270|NCT02461758|EG001|Reported Event|Standard Dose Influenza Vaccine (SDIV)|"This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.~40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme."
11238271|NCT02461771|BG000|Baseline|Cohort 1|4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
11238272|NCT02461771|BG001|Baseline|Cohort 2|10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
11238273|NCT02461771|BG002|Baseline|Cohort 3|20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
11238274|NCT02461771|BG003|Baseline|Total|Total of all reporting groups
11238275|NCT02461771|FG000|Participant Flow|Cohort 1|4 milligrams (mg) pegcetacoplan: Subjects received a single intravitreal (IVT) injection of pegcetacoplan (100 microliters [μL] of 40 mg per milliliter [mg/mL]) on Day 1.
11238276|NCT02461771|FG001|Participant Flow|Cohort 2|10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
11238277|NCT02461771|FG002|Participant Flow|Cohort 3|20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
11238278|NCT02461771|OG000|Outcome|Cohort 1|4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
11238279|NCT02461771|OG001|Outcome|Cohort 2|10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
11238280|NCT02461771|OG002|Outcome|Cohort 3|20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
11238281|NCT02461771|EG000|Reported Event|Cohort 1|4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
11238282|NCT02461771|EG001|Reported Event|Cohort 2|10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
11238283|NCT02461771|EG002|Reported Event|Cohort 3|20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
11238284|NCT02461966|BG000|Baseline|Hepatocellular Carcinoma (HCC)|"Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)~Aflatoxin: Evaluation of Aflatoxin level"
11238285|NCT02461966|BG001|Baseline|Cirrhotic Patients|"Estimation of serum aflatoxin level in 80 patients with liver cirrhosis~Aflatoxin: Evaluation of Aflatoxin level"
11238286|NCT02461966|BG002|Baseline|Control Group|"Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study~Aflatoxin: Evaluation of Aflatoxin level"
11238287|NCT02461966|BG003|Baseline|Total|Total of all reporting groups
11238288|NCT02461966|FG000|Participant Flow|Hepatocellular Carcinoma (HCC)|"Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)~Aflatoxin: Evaluation of Aflatoxin level"
11238289|NCT02461966|FG001|Participant Flow|Cirrhotic Patients|"Estimation of serum aflatoxin level in 80 patients with liver cirrhosis~Aflatoxin: Evaluation of Aflatoxin level"
11238290|NCT02461966|FG002|Participant Flow|Control Group|"Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study~Aflatoxin: Evaluation of Aflatoxin level"
11238291|NCT02461966|OG000|Outcome|Hepatocellular Carcinoma (HCC)|"Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)~Aflatoxin: Evaluation of Aflatoxin level"
11238292|NCT02461966|OG001|Outcome|80 Cirrhotic Patients|"Estimation of serum aflatoxin level in 80 patients with liver cirrhosis~Aflatoxin: Evaluation of Aflatoxin level"
11238293|NCT02461966|OG002|Outcome|Control Group|"Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study~Aflatoxin: Evaluation of Aflatoxin level"
11238294|NCT02461966|EG000|Reported Event|Hepatocellular Carcinoma (HCC)|"Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)~Aflatoxin: Evaluation of Aflatoxin level"
11238295|NCT02461966|EG001|Reported Event|Cirrhotic Patients|"Estimation of serum aflatoxin level in 80 patients with liver cirrhosis~Aflatoxin: Evaluation of Aflatoxin level"
11238296|NCT02461966|EG002|Reported Event|Control Group|"Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study~Aflatoxin: Evaluation of Aflatoxin level"
11238297|NCT02461992|BG000|Baseline|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
11238298|NCT02461992|FG000|Participant Flow|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
11238299|NCT02461992|OG000|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
11238300|NCT02461992|EG000|Reported Event|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
11238301|NCT02462057|BG000|Baseline|Control Arm|This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.
11238302|NCT02462057|BG001|Baseline|Diabetes-specific|"This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.~Email message regarding the HealthyFood benefit"
11238303|NCT02462057|BG002|Baseline|Experience of Another Member|"This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.~Email message regarding the HealthyFood benefit"
11238304|NCT02462057|BG003|Baseline|Input From a Diabetes Expert|"This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.~Email message regarding the HealthyFood benefit"
11238305|NCT02462057|BG004|Baseline|Enhanced Active Choice|"This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:~Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths~No, I'd prefer not to activate and continue paying full price for my healthy food purchases~Email message regarding the HealthyFood benefit"
11186746|NCT02102230|EG001|Reported Event|CBT-I-MA|"Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)~Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA): This is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it, along with links to web-based psychoeducational materials, easily accessible to users."
11186747|NCT02102230|EG002|Reported Event|Placebo|"Desensitization Treatment for Insomnia (DTI)~Desensitization Treatment for Insomnia: This is a group-delivered version of the sham sleep improvement treatment developed by Edinger which purports to desensitize the patient to the various aspects of the sleep experience which are presented as distressing."
11186748|NCT02102399|BG000|Baseline|Vocal Warm-up|Vocal Warm up group was performed during 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186749|NCT02102399|BG001|Baseline|Respiratory Muscle Training|Respiratory Muscle Training group was performed during 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186750|NCT02102399|BG002|Baseline|Total|Total of all reporting groups
11186751|NCT02102399|FG000|Participant Flow|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186752|NCT02102399|FG001|Participant Flow|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186753|NCT02102399|OG000|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186754|NCT02102399|OG001|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186755|NCT02102399|OG000|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
11186756|NCT02102399|OG001|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186757|NCT02102399|OG000|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186758|NCT02102399|OG001|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186759|NCT02102399|OG001|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
11186760|NCT02102399|EG000|Reported Event|Vocal Warm-up|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186761|NCT02102399|EG001|Reported Event|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
11186762|NCT02102464|BG000|Baseline|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11186763|NCT02102464|BG001|Baseline|Untreated Control|Untreated Control (No Intervention)
11186764|NCT02102464|BG002|Baseline|Total|Total of all reporting groups
11186765|NCT02102464|FG000|Participant Flow|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11186766|NCT02102464|FG001|Participant Flow|Untreated Control|Untreated Control (No Intervention)
11186767|NCT02102464|FG002|Participant Flow|Crossover LipiFlow|Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
11186768|NCT02102464|OG000|Outcome|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11186769|NCT02102464|OG001|Outcome|Untreated Control|Untreated Control (No Intervention)
11186770|NCT02102464|OG001|Outcome|Crossover LipiFlow Group|Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
11186771|NCT02102464|OG001|Outcome|Crossover LipiFlow|Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
11186772|NCT02102464|EG000|Reported Event|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
11186773|NCT02102464|EG001|Reported Event|Untreated Control|Untreated Control (No Intervention)
11186774|NCT02102464|EG002|Reported Event|Crossover LipiFlow Group|Untreated Control Group received a single 12-minute Crossover LipiFlow treatment at the 3-Months visit.
11238306|NCT02462057|BG005|Baseline|Total|Total of all reporting groups
10962002|NCT00864097|BG003|Baseline|Tanezumab 10 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962003|NCT00864097|BG004|Baseline|Total|Total of all reporting groups
11238307|NCT02462057|FG000|Participant Flow|Control Arm|This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.
11238308|NCT02462057|FG001|Participant Flow|Diabetes-specific|"This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.~Email message regarding the HealthyFood benefit"
11238309|NCT02462057|FG002|Participant Flow|Experience of Another Member|"This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.~Email message regarding the HealthyFood benefit"
11238310|NCT02462057|FG003|Participant Flow|Input From a Diabetes Expert|"This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.~Email message regarding the HealthyFood benefit"
11238311|NCT02462057|FG004|Participant Flow|Enhanced Active Choice|"This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:~Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths~No, I'd prefer not to activate and continue paying full price for my healthy food purchases~Email message regarding the HealthyFood benefit"
11238312|NCT02462057|OG000|Outcome|Control Arm|This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.
11238313|NCT02462057|OG001|Outcome|Diabetes-specific|"This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.~Email message regarding the HealthyFood benefit"
11238314|NCT02462057|OG002|Outcome|Experience of Another Member|"This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.~Email message regarding the HealthyFood benefit"
11238315|NCT02462057|OG003|Outcome|Input From a Diabetes Expert|"This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.~Email message regarding the HealthyFood benefit"
11238316|NCT02462057|OG004|Outcome|Enhanced Active Choice|"This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:~Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths~No, I'd prefer not to activate and continue paying full price for my healthy food purchases~Email message regarding the HealthyFood benefit"
11238317|NCT02462057|EG000|Reported Event|Control Arm|This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.
11238318|NCT02462057|EG001|Reported Event|Diabetes-specific|"This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.~Email message regarding the HealthyFood benefit"
11238319|NCT02462057|EG002|Reported Event|Experience of Another Member|"This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.~Email message regarding the HealthyFood benefit"
11238320|NCT02462057|EG003|Reported Event|Input From a Diabetes Expert|"This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.~Email message regarding the HealthyFood benefit"
11238321|NCT02462057|EG004|Reported Event|Enhanced Active Choice|"This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:~Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths~No, I'd prefer not to activate and continue paying full price for my healthy food purchases~Email message regarding the HealthyFood benefit"
11238322|NCT02462070|BG000|Baseline|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11238323|NCT02462070|BG001|Baseline|IDP-118 Vehicle Lotion|"Vehicle Lotion~IDP-118 Vehicle Lotion: Lotion"
11238324|NCT02462070|BG002|Baseline|Total|Total of all reporting groups
11238325|NCT02462070|FG000|Participant Flow|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11238326|NCT02462070|FG001|Participant Flow|IDP-118 Vehicle Lotion|"Vehicle Lotion~IDP-118 Vehicle Lotion: Lotion"
11238327|NCT02462070|OG000|Outcome|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11238328|NCT02462070|OG001|Outcome|IDP-118 Vehicle Lotion|"Vehicle Lotion~IDP-118 Vehicle Lotion: Lotion"
11238329|NCT02462070|EG000|Reported Event|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11238330|NCT02462070|EG001|Reported Event|IDP-118 Vehicle Lotion|"Vehicle Lotion~IDP-118 Vehicle Lotion: Lotion"
11238331|NCT02462083|BG000|Baseline|IDP-118 Lotion|IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
11238332|NCT02462083|FG000|Participant Flow|IDP-18 Lotion|IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
11238333|NCT02462083|OG000|Outcome|IDP-118 Lotion|IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
11238334|NCT02462083|EG000|Reported Event|IDP-118 Lotion|IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
11238335|NCT02462122|BG000|Baseline|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11238336|NCT02462122|BG001|Baseline|IDP-118 Vehicle Lotion|"Vehicle Lotion~IDP-118 Vehicle Lotion: Lotion"
11238337|NCT02462122|BG002|Baseline|Total|Total of all reporting groups
11238338|NCT02462122|FG000|Participant Flow|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11238339|NCT02462122|FG001|Participant Flow|IDP-118 Vehicle Lotion|"Vehicle Lotion~IDP-118 Vehicle Lotion: Lotion"
11238340|NCT02462122|OG000|Outcome|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11238341|NCT02462122|OG001|Outcome|IDP-118 Vehicle Lotion|"Vehicle Lotion~IDP-118 Vehicle Lotion: Lotion"
11238342|NCT02462122|EG000|Reported Event|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11238343|NCT02462122|EG001|Reported Event|IDP-118 Vehicle Lotion|"Vehicle Lotion~IDP-118 Vehicle Lotion: Lotion"
11238344|NCT02462148|BG000|Baseline|4 mg Perineural Dexamethasone Group|"4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Dexamethasone: Used in nerve block mixture~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238345|NCT02462148|BG001|Baseline|1 mg Perineural Dexamethasone Group|"1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Dexamethasone: Used in nerve block mixture~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238346|NCT02462148|BG002|Baseline|Placebo Group|"This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238347|NCT02462148|BG003|Baseline|Total|Total of all reporting groups
11238348|NCT02462148|FG000|Participant Flow|4 mg Perineural Dexamethasone Group|"4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Dexamethasone: Used in nerve block mixture~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238349|NCT02462148|FG001|Participant Flow|1 mg Perineural Dexamethasone Group|"1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Dexamethasone: Used in nerve block mixture~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238350|NCT02462148|FG002|Participant Flow|Placebo Group|"This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238351|NCT02462148|OG000|Outcome|4 mg Perineural Dexamethasone Group|"4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Dexamethasone: Used in nerve block mixture~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238352|NCT02462148|OG001|Outcome|1 mg Perineural Dexamethasone Group|"1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Dexamethasone: Used in nerve block mixture~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238353|NCT02462148|OG002|Outcome|Placebo Group|"This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238354|NCT02462148|OG000|Outcome|4mg Perineural Dexamethasone|"4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Resting pain score 0 hours post-op"
11238355|NCT02462148|OG001|Outcome|1 mg Perineural Dexamethasone|"1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Resting pain score 0 hours post-op"
11186775|NCT02102490|BG000|Baseline|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
11186776|NCT02102490|FG000|Participant Flow|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
10962004|NCT00864097|FG000|Participant Flow|Placebo + Diclofenac|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 milligram (mg) slow release tablet orally twice daily up to Week 32.
11186777|NCT02102490|OG000|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
11186778|NCT02102490|EG000|Reported Event|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
11186779|NCT02102724|BG000|Baseline|Fish Oil|"Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks.~Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids"
11186780|NCT02102724|BG001|Baseline|Placebo|"Participants will receive 1 gram of oleic sunflower oil for 12 weeks.~Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids"
11186781|NCT02102724|BG002|Baseline|Total|Total of all reporting groups
11186782|NCT02102724|FG000|Participant Flow|Fish Oil|"Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks.~Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids"
11186783|NCT02102724|FG001|Participant Flow|Placebo|"Participants will receive 1 gram of oleic sunflower oil for 12 weeks.~Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids"
11186784|NCT02102724|OG000|Outcome|Fish Oil|"Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks.~Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids"
11186785|NCT02102724|OG001|Outcome|Placebo|"Participants will receive 1 gram of oleic sunflower oil for 12 weeks.~Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids"
11186786|NCT02102724|EG000|Reported Event|Fish Oil|"Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks.~Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids"
11186787|NCT02102724|EG001|Reported Event|Placebo|"Participants will receive 1 gram of oleic sunflower oil for 12 weeks.~Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids"
11186788|NCT02102932|BG000|Baseline|T1R1|"Study Part 1:~T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
11186789|NCT02102932|BG001|Baseline|R1T1|"Study Part 1:~R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
11186790|NCT02102932|BG002|Baseline|T2R2|"Study Part 2:~T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
11186791|NCT02102932|BG003|Baseline|R2T2|"Study part 2:~R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
11186792|NCT02102932|BG004|Baseline|T3R3|"Study Part 3:~T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
11186793|NCT02102932|BG005|Baseline|R3T3|"Study Part 3:~R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
11186794|NCT02102932|BG006|Baseline|T4R4|"Study Part 4:~T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
11186795|NCT02102932|BG007|Baseline|R4T4|"Study Part 4:~R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
11186796|NCT02102932|BG008|Baseline|Total|Total of all reporting groups
11186797|NCT02102932|FG000|Participant Flow|T1R1|"Study Part 1:~T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
11186798|NCT02102932|FG001|Participant Flow|R1T1|"Study Part 1:~R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
10962005|NCT00864097|FG001|Participant Flow|Tanezumab 2.5 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962006|NCT00864097|FG002|Participant Flow|Tanezumab 5 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962007|NCT00864097|FG003|Participant Flow|Tanezumab 10 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962008|NCT00864097|OG000|Outcome|Placebo + Diclofenac|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 milligram (mg) slow release tablet orally twice daily up to Week 32.
11186799|NCT02102932|FG002|Participant Flow|T2R2|"Study Part 2:~T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
11186800|NCT02102932|FG003|Participant Flow|R2T2|"Study part 2:~R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
11186801|NCT02102932|FG004|Participant Flow|T3R3|"Study Part 3:~T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
11186802|NCT02102932|FG005|Participant Flow|R3T3|"Study Part 3:~R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
11186803|NCT02102932|FG006|Participant Flow|T4R4|"Study Part 4:~T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
11186804|NCT02102932|FG007|Participant Flow|R4T4|"Study Part 4:~R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
11186805|NCT02102932|OG000|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
11186806|NCT02102932|OG001|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
11186807|NCT02102932|OG002|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
10962009|NCT00864097|OG001|Outcome|Tanezumab 2.5 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
11186808|NCT02102932|OG003|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
11186809|NCT02102932|OG004|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
11186810|NCT02102932|OG005|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
11186811|NCT02102932|OG006|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
10962010|NCT00864097|OG002|Outcome|Tanezumab 5 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962011|NCT00864097|OG003|Outcome|Tanezumab 10 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962012|NCT00864097|EG000|Reported Event|Placebo + Diclofenac|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 milligram (mg) slow release tablet orally twice daily up to Week 32.
11186812|NCT02102932|OG007|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
10962013|NCT00864097|EG001|Reported Event|Tanezumab 2.5 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962014|NCT00864097|EG002|Reported Event|Tanezumab 5 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962015|NCT00864097|EG003|Reported Event|Tanezumab 10 mg + Diclofenac|Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
10962016|NCT00864123|BG000|Baseline|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
11186813|NCT02102932|EG000|Reported Event|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
11186814|NCT02102932|EG001|Reported Event|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
11186815|NCT02102932|EG002|Reported Event|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
11186816|NCT02102932|EG003|Reported Event|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
11186817|NCT02102932|EG004|Reported Event|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
11186818|NCT02102932|EG005|Reported Event|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
11186819|NCT02102932|EG006|Reported Event|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
11186820|NCT02102932|EG007|Reported Event|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
11186821|NCT02103062|BG000|Baseline|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186822|NCT02103062|BG001|Baseline|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186823|NCT02103062|BG002|Baseline|Total|Total of all reporting groups
11186824|NCT02103062|FG000|Participant Flow|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186825|NCT02103062|FG001|Participant Flow|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186826|NCT02103062|OG000|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186827|NCT02103062|OG001|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186828|NCT02103062|OG000|Outcome|RAS Wildtype Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186829|NCT02103062|OG001|Outcome|RAS Mutated Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186830|NCT02103062|EG000|Reported Event|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186831|NCT02103062|EG001|Reported Event|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11186832|NCT02103114|BG000|Baseline|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
11186833|NCT02103114|BG001|Baseline|Placebo|Placebo: Normal saline placebo
11186834|NCT02103114|BG002|Baseline|Total|Total of all reporting groups
11186835|NCT02103114|FG000|Participant Flow|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
11186836|NCT02103114|FG001|Participant Flow|Placebo|Normal saline placebo
11186837|NCT02103114|OG000|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
11186838|NCT02103114|OG001|Outcome|Placebo|Normal saline placebo
11186839|NCT02103114|OG001|Outcome|Placebo|Placebo: Normal saline placebo
11186840|NCT02103114|EG000|Reported Event|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
11186841|NCT02103114|EG001|Reported Event|Placebo|Normal saline placebo
11186842|NCT02103127|BG000|Baseline|755nm Alexandrite Laser With Lens Array|755nm Alexandrite laser with lens array
11186843|NCT02103127|FG000|Participant Flow|755nm Alexandrite Laser With Lens Array|755nm Alexandrite laser with lens array
11186844|NCT02103127|OG000|Outcome|755nm Alexandrite Laser With Lens Array|755nm Alexandrite laser with lens array
11186845|NCT02103127|EG000|Reported Event|755nm Alexandrite Laser With Lens Array|755nm Alexandrite laser with lens array
11186846|NCT02103153|BG000|Baseline|Picosure Laser System|Picosure Laser System
11186847|NCT02103153|FG000|Participant Flow|Picosure Laser System|Subjects will be treated with 1064nm, 532nm, or 755nm in combination or individually, depending on the color of the tattoo and the skin type of the subject. Since the purpose of the study is to test the overall clearance of the tattoo, breaking the results down by wavelengths is extraneous information. The primary purpose of the study is not to compare the wavelengths against each other, but rather, to examine the overall clearance created by the Picosure Laser System. Furthermore, each wavelength is designed to target a specific color, so a multi-colored tattoo will have a variety of wavelengths used (in combination and individually), all for the primary objective of indicating overall tattoo clearance.
11186848|NCT02103153|OG000|Outcome|Picosure Laser System|Picosure Laser System, using a combination of combination or individual frequencies of 532 nm, 755 nm, or 1064 nm.
11186849|NCT02103153|OG000|Outcome|Picosure Laser System|Subjects will be treated with 1064nm, 532nm, or 755nm in combination or individually, depending on the color of the tattoo and the skin type of the subject. Each wavelength is designed to target a specific color, so a multi-colored tattoo will have a variety of wavelengths used (in combination and individually), all for the primary objective of indicating overall tattoo clearance.
11186850|NCT02103153|EG000|Reported Event|Picosure Laser System- 532 nm Wavelength|Picosure Laser System, using a frequency of 532 nm
11186851|NCT02103153|EG001|Reported Event|Picosure Laser System- 755 nm Wavelength|Picosure Laser System, using a frequency of 755 nm
11186852|NCT02103153|EG002|Reported Event|Picosure Laser System- 1064 nm Wavelength|Picosure Laser System, using a frequency of 1064 nm
11186853|NCT02103218|BG000|Baseline|Risky Sex Prevention-Daughters|Education, activities, empowerment, racial pride building...
11186854|NCT02103218|BG001|Baseline|Healthy Behaviors-Daughters|General health education, activities
11186855|NCT02103218|BG002|Baseline|Risky Sex Prevention-Mothers|Activities, empowerment, communication.....
11186856|NCT02103218|BG003|Baseline|Healthy Behaviors-Mothers|General health education, activities
11186857|NCT02103218|BG004|Baseline|Total|Total of all reporting groups
11186858|NCT02103218|FG000|Participant Flow|Risky Sex Prevention-Daughters|Education, activities, empowerment, racial pride building...
11238356|NCT02462148|OG002|Outcome|Placebo|"This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.~Resting Pain score 0 hours post-op"
11238357|NCT02462148|EG000|Reported Event|4 mg Perineural Dexamethasone Group|"4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Dexamethasone: Used in nerve block mixture~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238358|NCT02462148|EG001|Reported Event|1 mg Perineural Dexamethasone Group|"1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.~Dexamethasone: Used in nerve block mixture~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238359|NCT02462148|EG002|Reported Event|Placebo Group|"This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.~Bupivacaine: Used in nerve block mixture~Epinephrine: Used in nerve block mixture~Saphenous Peripheral Nerve Block: Peripheral nerve block."
11238360|NCT02462291|BG000|Baseline|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
11238361|NCT02462291|BG001|Baseline|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
11238362|NCT02462291|BG002|Baseline|Total|Total of all reporting groups
11238363|NCT02462291|FG000|Participant Flow|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
11238364|NCT02462291|FG001|Participant Flow|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
11238365|NCT02462291|OG000|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
11238366|NCT02462291|OG001|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
11238367|NCT02462291|OG001|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
11238368|NCT02462291|OG001|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
11238369|NCT02462291|EG000|Reported Event|Experimental Group (TR)|"A group of 82 patients with AD will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
11238370|NCT02462291|EG001|Reported Event|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
11238371|NCT02462382|BG000|Baseline|Ropivacaine Infusion|"270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.~Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.~Ropivacaine"
11238372|NCT02462382|BG001|Baseline|Saline Infusion|"270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.~Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.~Saline"
11238373|NCT02462382|BG002|Baseline|Total|Total of all reporting groups
11238374|NCT02462382|FG000|Participant Flow|Ropivacaine Infusion|"270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.~Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.~Ropivacaine"
11238375|NCT02462382|FG001|Participant Flow|Saline Infusion|"270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.~Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.~Saline"
11186859|NCT02103218|FG001|Participant Flow|Healthy Behaviors-Daughters|General health education, activities
11186860|NCT02103218|FG002|Participant Flow|Risky Sex Prevention-Mothers|Activities, empowerment, communication...
11186861|NCT02103218|FG003|Participant Flow|Healthy Behaviors-Mothers|General health education, activities
11186862|NCT02103218|OG000|Outcome|Risky Sex Prevention|Education, activities, empowerment, racial pride building...
11186863|NCT02103218|OG001|Outcome|Healthy Behaviors|General health education, activities
11186864|NCT02103218|EG000|Reported Event|Risky Sex Prevention-Daughters|"education, activities, empowerment, racial pride building~Education, activities, empowerment, racial pride building: Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females."
11186865|NCT02103218|EG001|Reported Event|Healthy Behaviors-Daughters|"General health education, activities~General Health education, activities: Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex)."
11186866|NCT02103218|EG002|Reported Event|Risky Sex Prevention-Mothers|Activities, empowerment
11186867|NCT02103218|EG003|Reported Event|Healthy Behaviors-Mothers|General health education, activities
11186868|NCT02103270|BG000|Baseline|Peanut 4000|Oral immunotherapy with peanut discontinuation arm
11186869|NCT02103270|BG001|Baseline|Peanut 300|Oral immunotherapy with low dose peanut continuation arm.
11186870|NCT02103270|BG002|Baseline|Placebo Comparator: Oat Flour 600 mg|Placebo received oat flour
11186871|NCT02103270|BG003|Baseline|Total|Total of all reporting groups
11186872|NCT02103270|FG000|Participant Flow|Peanut-4000|Oral immunotherapy with peanut discontinuation arm
11186873|NCT02103270|FG001|Participant Flow|Peanut-300|Oral immunotherapy with low dose peanut continuation arm
11186874|NCT02103270|FG002|Participant Flow|Placebo Comparator: Oat Flour 600 mg|Placebo received oat flour
11186875|NCT02103270|OG000|Outcome|Peanut 4000|Oral immunotherapy with peanut discontinuation arm
11186876|NCT02103270|OG001|Outcome|Peanut 300|Oral immunotherapy with low dose peanut continuation arm.
11186877|NCT02103270|OG002|Outcome|Placebo Comparator: Oat Flour 600 mg|Placebo received oat flour
11186878|NCT02103270|OG000|Outcome|Peanut 4000|"Arm A on peanut OIT until week 104 (maintenance) and once meeting criteria on OIT treatment for minimum 104 weeks, 2) taking daily maintenance dose of 4,000 mg protein for at least 13 weeks, 3) no severe reactions to home dosing from Week 91-Week 104, and 4) no reactions at the Week 104 DBPCFC] will be assigned to avoid peanut (i.e. will consume 600 mg oat flour daily) and will proceed to tolerance and desensitization phase.~Peanut Protein 4,000mg: Arm A will be defined as clinically tolerant if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria (Appendix 4). Individuals in Arm A who meet the definition of clinically tolerant will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity.~Oat Flour: Arm C will be defined as natural l"
11186879|NCT02103270|OG001|Outcome|Peanut 300|"Arm B on peanut OIT until week 104 and once meeting criteria specified in description of Arm A, will be assigned to be maintained on 300 mg peanut protein (i.e. 600 mg peanut flour) daily and will proceed to the tolerance and desensitization testing phase.~Oat Flour: Arm C will be defined as natural loss of responsiveness if they show no clinical reactivity at DBPCFCs (week 117 to end of study).~Peanut Protein 300 mg: Arm B will be defined as desensitized to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study)."
11186880|NCT02103270|OG002|Outcome|Placebo Comparator: Oat Flour 600 mg|"Arm C that is maintained on placebo (oat flour) throughout the study; this arm will receive 600 mg oat flour beginning on week 104. This will be true even if a subject in the placebo group meets criteria at week 104~Oat Flour: Arm C will be defined as natural loss of responsiveness if they show no clinical reactivity at DBPCFCs (week 117 to end of study)."
11186881|NCT02103270|EG000|Reported Event|Peanut-4000|Oral immunotherapy with peanut discontinuation arm
11186882|NCT02103270|EG001|Reported Event|Peanut-300|Oral immunotherapy with low dose peanut continuation arm
11186883|NCT02103270|EG002|Reported Event|Placebo Comparator: Oat Flour 600 mg|Placebo received oat flour
11186884|NCT02103309|BG000|Baseline|Overall|DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment.
11186885|NCT02103309|FG000|Participant Flow|DACP, Then 1DAM|Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
11186886|NCT02103309|FG001|Participant Flow|1DAM, Then DACP|Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
11186887|NCT02103309|OG000|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
11186888|NCT02103309|OG001|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
11186889|NCT02103309|EG000|Reported Event|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
11186890|NCT02103309|EG001|Reported Event|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
11186891|NCT02103439|BG000|Baseline|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186892|NCT02103439|BG001|Baseline|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186893|NCT02103439|BG002|Baseline|Total|Total of all reporting groups
11186894|NCT02103439|FG000|Participant Flow|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186895|NCT02103439|FG001|Participant Flow|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186896|NCT02103439|OG000|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186897|NCT02103439|OG001|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186898|NCT02103439|OG000|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186899|NCT02103439|OG001|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186900|NCT02103439|OG002|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186901|NCT02103439|OG003|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186902|NCT02103439|EG000|Reported Event|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
11186903|NCT02103439|EG001|Reported Event|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week~The safety analysis included 71 patients received at least 1 dose of PegIntron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [previous treatment of hepatitis C with interferon alfa], who was withdrawn from the mITT-analysis)"
11186904|NCT02103478|BG000|Baseline|Phase 1 Dose Escalation Cohort 1|Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186905|NCT02103478|BG001|Baseline|Phase 1 Dose Escalation Cohort 2|Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186906|NCT02103478|BG002|Baseline|Phase 1 Dose Escalation Cohort 3|Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186907|NCT02103478|BG003|Baseline|Phase 1 Dose Escalation Cohort 4|Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186908|NCT02103478|BG004|Baseline|Phase 1 Dose Escalation Cohort 5|Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186909|NCT02103478|BG005|Baseline|Phase 2 Dose Confirmation|Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11359263|NCT03152526|FG001|Participant Flow|CD3-/CD56+ NK Cells Followed by IL-2|After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
11238376|NCT02462382|OG000|Outcome|Ropivacaine Infusion|"270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.~Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.~Ropivacaine"
11238377|NCT02462382|OG001|Outcome|Saline Infusion|"270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.~Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.~Saline"
11238378|NCT02462382|EG000|Reported Event|Ropivacaine Infusion|"270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.~Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.~Ropivacaine"
11238379|NCT02462382|EG001|Reported Event|Saline Infusion|"270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.~Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.~Saline"
11238380|NCT02462473|BG000|Baseline|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
11238381|NCT02462473|FG000|Participant Flow|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
11238382|NCT02462473|OG000|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
11238383|NCT02462473|EG000|Reported Event|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
11238384|NCT02462486|BG000|Baseline|Abicipar Pegol 2 mg (2Q8)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238385|NCT02462486|BG001|Baseline|Abicipar Pegol 2 mg (2Q12)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238386|NCT02462486|BG002|Baseline|Ranibizumab (rQ4)|Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
11238387|NCT02462486|BG003|Baseline|Total|Total of all reporting groups
11238388|NCT02462486|FG000|Participant Flow|Abicipar Pegol 2 mg (2Q8)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238389|NCT02462486|FG001|Participant Flow|Abicipar Pegol 2 mg (2Q12)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238390|NCT02462486|FG002|Participant Flow|Ranibizumab (rQ4)|Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
11238391|NCT02462486|OG000|Outcome|Abicipar Pegol 2 mg (2Q8)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238392|NCT02462486|OG001|Outcome|Abicipar Pegol 2 mg (2Q12)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238393|NCT02462486|OG002|Outcome|Ranibizumab (rQ4)|Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
11359264|NCT03152526|OG000|Outcome|CD3-/CD19- NK Cells Followed by IL-2|After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
11359265|NCT03152526|OG001|Outcome|CD3-/CD56+ NK Cells Followed by IL-2|After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
11359266|NCT03152526|EG000|Reported Event|CD3-/CD19- NK Cells Followed by IL-2|After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
11359267|NCT03152526|EG001|Reported Event|CD3-/CD56+ NK Cells Followed by IL-2|After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
11359268|NCT03161964|BG000|Baseline|Propranolol|"After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Propranolol Arm will be treated with Propranolol 80 Mg Oral Capsule, Extended Release daily for four weeks.~Propranolol 80 Mg Oral Capsule, Extended Release: Propranolol capsule over-encapsulated to match placebo for blinding"
11359269|NCT03161964|BG001|Baseline|Placebo|"After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Placebo Arm will be treated with matching placebo oral capsule daily for four weeks.~Placebo oral capsule: Placebo capsule over-encapsulated to match propranolol for blinding"
11359270|NCT03161964|BG002|Baseline|Total|Total of all reporting groups
11359271|NCT03161964|FG000|Participant Flow|Propranolol|"After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Propranolol Arm will be treated with Propranolol 80 Mg Oral Capsule, Extended Release daily for four weeks.~Propranolol 80 Mg Oral Capsule, Extended Release: Propranolol capsule over-encapsulated to match placebo for blinding"
11359272|NCT03161964|FG001|Participant Flow|Placebo|"After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Placebo Arm will be treated with matching placebo oral capsule daily for four weeks.~Placebo oral capsule: Placebo capsule over-encapsulated to match propranolol for blinding"
11359273|NCT03161964|OG000|Outcome|Propranolol|"After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Propranolol Arm will be treated with Propranolol 80 Mg Oral Capsule, Extended Release daily for four weeks.~Propranolol 80 Mg Oral Capsule, Extended Release: Propranolol capsule over-encapsulated to match placebo for blinding"
11359274|NCT03161964|OG001|Outcome|Placebo|"After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Placebo Arm will be treated with matching placebo oral capsule daily for four weeks.~Placebo oral capsule: Placebo capsule over-encapsulated to match propranolol for blinding"
11359275|NCT03161964|EG000|Reported Event|Propranolol|"After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Propranolol Arm will be treated with Propranolol 80 Mg Oral Capsule, Extended Release daily for four weeks.~Propranolol 80 Mg Oral Capsule, Extended Release: Propranolol capsule over-encapsulated to match placebo for blinding"
11359276|NCT03161964|EG001|Reported Event|Placebo|"After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Placebo Arm will be treated with matching placebo oral capsule daily for four weeks.~Placebo oral capsule: Placebo capsule over-encapsulated to match propranolol for blinding"
11359277|NCT03150160|BG000|Baseline|Simbrinza + Travatan|Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
11359278|NCT03150160|BG001|Baseline|Placebo + Travatan|Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
11359279|NCT03150160|BG002|Baseline|Total|Total of all reporting groups
11359280|NCT03150160|FG000|Participant Flow|Simbrinza + Travatan|Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
11359281|NCT03150160|FG001|Participant Flow|Placebo + Travatan|Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
11359282|NCT03150160|OG000|Outcome|Simbrinza + Travatan|Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
11359283|NCT03150160|OG001|Outcome|Placebo + Travatan|Placebo + travoprost 0.004% ophthalmic solution
11359284|NCT03150160|EG000|Reported Event|Simbrinza + Travatan|Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
11359285|NCT03150160|EG001|Reported Event|Placebo + Travatan|Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
11359286|NCT03137225|BG000|Baseline|NIPPV Then NAVA Mode|"After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.~The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode.~These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, at the same PEEP (positive end-expiratory pressure) and respiratory rate.~One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA)"
11186910|NCT02103478|BG006|Baseline|Phase 2 Fixed-Dose Combination|Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186911|NCT02103478|BG007|Baseline|Total|Total of all reporting groups
11186912|NCT02103478|FG000|Participant Flow|Phase 1 Dose Escalation Cohort 1|Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186913|NCT02103478|FG001|Participant Flow|Phase 1 Dose Escalation Cohort 2|Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186914|NCT02103478|FG002|Participant Flow|Phase 1 Dose Escalation Cohort 3|Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186915|NCT02103478|FG003|Participant Flow|Phase 1 Dose Escalation Cohort 4|Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186916|NCT02103478|FG004|Participant Flow|Phase 1 Dose Escalation Cohort 5|Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186917|NCT02103478|FG005|Participant Flow|Phase 2 Dose Confirmation Sequence A|Participants were randomized in a 1:1 ratio to receive oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) in Sequence A. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186918|NCT02103478|FG006|Participant Flow|Phase 2 Dose Confirmation Sequence B|Participants were randomized in a 1:1 ratio to receive IV decibatine (20 mg/m^2) Dailyx5 in Course 1 followed by oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 2 (28 days per course) in Sequence B. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186919|NCT02103478|FG007|Participant Flow|Phase 2 Fixed-Dose Combination Sequence A|Participants were randomized in a 1:1 ratio to receive oral cedazuridine (100 mg) + decitabine (35 mg) tablets Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) in Sequence A. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186920|NCT02103478|FG008|Participant Flow|Phase 2 Fixed-Dose Combination Sequence B|Participants were randomized in a 1:1 ratio to receive IV decibatine (20 mg/m^2) Dailyx5 in Course 1 followed by oral cedazuridine (100 mg) + decitabine (35 mg) tablets Dailyx5 in Course 2 (28 days per course) in Sequence B. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186921|NCT02103478|OG000|Outcome|Phase 1 Dose Escalation Cohort 1|Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186922|NCT02103478|OG001|Outcome|Phase 1 Dose Escalation Cohort 2|Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186923|NCT02103478|OG002|Outcome|Phase 1 Dose Escalation Cohort 3|Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186924|NCT02103478|OG003|Outcome|Phase 1 Dose Escalation Cohort 4|Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11238394|NCT02462486|EG000|Reported Event|Abicipar Pegol 2 mg (2Q8)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238395|NCT02462486|EG001|Reported Event|Abicipar Pegol 2 mg (2Q12)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238396|NCT02462486|EG002|Reported Event|Ranibizumab (rQ4)|Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
11238397|NCT02462720|BG000|Baseline|Varithena®|"Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use followed by Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care followed by Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use"
11238398|NCT02462720|FG000|Participant Flow|Varithena® First Then Radiofrequency Ablation|"Patients receive Varithena® treatment first in one leg, with 4-week follow-up period in Part 1; followed by Radiofrequency ablation in the other leg in Part 2.~Varithena® treatment administered in accordance with full prescribing information and instructions for use.~Radiofrequency ablation conducted per physicians' standard of care"
11238399|NCT02462720|FG001|Participant Flow|Radiofrequency Ablation First Than Varithena|"Patients will receive radiofrequency ablation treatment first in one leg, with 4-week follow-up period in Part 1; followed by Varithena® in the other leg in Part 2.~Varithena® treatment administered in accordance with full prescribing information and instructions for use.~Radiofrequency ablation conducted per physicians' standard of care"
11238400|NCT02462720|OG000|Outcome|Varithena®|"Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used.~Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
11238401|NCT02462720|OG001|Outcome|Radiofrequency Ablation|"RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use.~Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
11238402|NCT02462720|OG000|Outcome|Varithena®|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
11238403|NCT02462720|OG001|Outcome|Radiofrequency Ablation|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
11238404|NCT02462720|EG000|Reported Event|Varithena®|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
11238405|NCT02462720|EG001|Reported Event|Radiofrequency Ablation|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
11238406|NCT02462759|BG000|Baseline|Sham Procedure (Part 1)|Sham procedure on Day 1, 15, 29, 64, 183 and 302.
11238407|NCT02462759|BG001|Baseline|ISIS 396443 (Part 1)|Single dose of 9.6 milligrams (mg) to 12.0 mg ISIS 396443, based on participant's age, intrathecal bolus injection loading doses on Day 1, 15, 29, 64 and maintenance doses, every 4 months, on Day 183 and 302.
11238408|NCT02462759|BG002|Baseline|Total|Total of all reporting groups
11238409|NCT02462759|FG000|Participant Flow|Sham Procedure (Part 1)|Sham procedure on Day 1, 15, 29, 64, 183 and 302.
11238410|NCT02462759|FG001|Participant Flow|ISIS 396443 (Part 1)|Single dose of 9.6 milligrams (mg) to 12.0 mg ISIS 396443, based on participant's age, intrathecal bolus injection loading doses on Day 1, 15, 29, 64 and maintenance doses, every 4 months, on Day 183 and 302.
11238411|NCT02462759|FG002|Participant Flow|ISIS 396443 (Part 2)|Participants who were in Sham procedure group in Part 1, received single dose of 12.0 mg ISIS 396443 intrathecal bolus injection loading doses on Day 1, 15, 29, 64 and maintenance doses, every 4 months, on Day 183, 302, 421, 540, 659 and 778 in Part 2; participants who were in ISIS 396443 group in Part 1 continued to receive a single dose of 9.6 mg to 12.0 mg ISIS 396443 intrathecal bolus injection maintenance doses on Day 1, 120, 239, 358, 477, 596 and 715 in Part 2.
11238412|NCT02462759|OG000|Outcome|Sham Procedure in Part 1|Participants who received single dose of sham procedure on Day 1, 15, 29, 64, 183 and 302 in Part 1 of the study.
11238413|NCT02462759|OG001|Outcome|ISIS 396443 Part 2(Participants on Sham in Part 1)|Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183, 302, 421, 540, 659 and 778 in Part 2.
11238414|NCT02462759|OG002|Outcome|ISIS 396443 Part 1 & 2|Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183 and 302 in Part 1 of the study and then received single dose of ISIS 396443 on Day 1, 120, 239, 358, 477, 596 and 715 in Part 2 of the study.
11238415|NCT02462759|OG000|Outcome|ISIS 396443 Part 2(Participants on Sham in Part 1)|Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183, 302, 421, 540, 659 and 778 in Part 2.
11238416|NCT02462759|OG001|Outcome|ISIS 396443 Part 1 & 2|Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183 and 302 in Part 1 of the study and then received single dose of ISIS 396443 on Day 1, 120, 239, 358, 477, 596 and 715 in Part 2 of the study.
11238417|NCT02462759|OG000|Outcome|ISIS 396443 Part 1 & 2|Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183 and 302 in Part 1 of the study and then received single dose of ISIS 396443 on Day 1, 120, 239, 358, 477, 596 and 715 in Part 2 of the study.
11186925|NCT02103478|OG004|Outcome|Phase 1 Dose Escalation Cohort 5|Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186926|NCT02103478|OG000|Outcome|Phase 2 Dose Confirmation|Participants were randomized in a 1:1 ratio to receive either Sequence A: Oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2; or Sequence B: IV decitabine (20 mg/m^2) Dailyx5 in Course 1 followed by cedazuridine + decitabine capsules Dailyx5 in Course 2 (28 days per course). In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186927|NCT02103478|OG001|Outcome|Phase 2 Fixed-Dose Combination|Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186928|NCT02103478|OG000|Outcome|Phase 2 Dose Confirmation|Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186929|NCT02103478|OG005|Outcome|Phase 2 Dose Confirmation|Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186930|NCT02103478|OG006|Outcome|Phase 2 Fixed-Dose Combination|Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186931|NCT02103478|OG000|Outcome|Phase 1 Dose Escalation Cohort 1|"Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).~ASTX727 Dose Escalation: Oral investigational product and approved IV decitabine"
11186932|NCT02103478|OG001|Outcome|Phase 1 Dose Escalation Cohort 2|"Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).~ASTX727 Dose Escalation: Oral investigational product and approved IV decitabine"
11186933|NCT02103478|OG002|Outcome|Phase 1 Dose Escalation Cohort 3|"Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).~ASTX727 Dose Escalation: Oral investigational product and approved IV decitabine"
11186934|NCT02103478|OG003|Outcome|Phase 1 Dose Escalation Cohort 4|"Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).~ASTX727 Dose Escalation: Oral investigational product and approved IV decitabine"
11186935|NCT02103478|OG004|Outcome|Phase 1 Dose Escalation Cohort 5|"Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).~ASTX727 Dose Escalation: Oral investigational product and approved IV decitabine"
11186936|NCT02103478|OG004|Outcome|Phase 1 Dose Escalation Cohort 5|Cohort 1 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186937|NCT02103478|OG000|Outcome|Phase 1 Dose Escalation Cohort 1|Starting cohort was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186938|NCT02103478|OG001|Outcome|Phase 1 Dose Escalation Cohort 2|Starting cohort was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11238418|NCT02462759|EG000|Reported Event|Sham Procedure in Part 1|Participants who received single dose of sham procedure on Day 1, 15, 29, 64, 183 and 302 in Part 1 of the study.
11238419|NCT02462759|EG001|Reported Event|ISIS 396443 Part 1 & 2|Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183 and 302 in Part 1 of the study and then received single dose of ISIS 396443 on Day 1, 120, 239, 358, 477, 596 and 715 in Part 2 of the study.
11238420|NCT02462759|EG002|Reported Event|ISIS 396443 Part 2(Participants on Sham in Part 1)|Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183, 302, 421, 540, 659 and 778 in Part 2.
11238421|NCT02462928|BG000|Baseline|Abicipar Pegol 2 mg (2Q8)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238422|NCT02462928|BG001|Baseline|Abicipar Pegol 2 mg (2Q12)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238423|NCT02462928|BG002|Baseline|Ranibizumab 0.5 mg (rQ4)|Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
11238424|NCT02462928|BG003|Baseline|Total|Total of all reporting groups
11238425|NCT02462928|FG000|Participant Flow|Abicipar Pegol 2 mg (2Q8)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238426|NCT02462928|FG001|Participant Flow|Abicipar Pegol 2 mg (2Q12)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238427|NCT02462928|FG002|Participant Flow|Ranibizumab 0.5 mg (rQ4)|Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
11238428|NCT02462928|OG000|Outcome|Abicipar Pegol 2 mg (2Q8)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238429|NCT02462928|OG001|Outcome|Abicipar Pegol 2 mg (2Q12)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238430|NCT02462928|OG002|Outcome|Ranibizumab 0.5 mg (rQ4)|Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
11238431|NCT02462928|EG000|Reported Event|Abicipar Pegol 2 mg (2Q8)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238432|NCT02462928|EG001|Reported Event|Abicipar Pegol 2 mg (2Q12)|Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
11238433|NCT02462928|EG002|Reported Event|Ranibizumab 0.5 mg (rQ4)|Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
11238434|NCT02462967|BG000|Baseline|2 mg/kg GR MD 02|"GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions~GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3"
11238435|NCT02462967|BG001|Baseline|8 mg/kg GR MD 02|"GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions~GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3"
11238436|NCT02462967|BG002|Baseline|Placebo|"Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions~Placebo: Placebo for GR-MD-02"
11238437|NCT02462967|BG003|Baseline|Total|Total of all reporting groups
11238438|NCT02462967|FG000|Participant Flow|2 mg/kg GR MD 02|"GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions~GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3"
11238439|NCT02462967|FG001|Participant Flow|8 mg/kg GR MD 02|"GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions~GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3"
11238440|NCT02462967|FG002|Participant Flow|Placebo|"Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions~Placebo: Placebo for GR-MD-02"
11238441|NCT02462967|OG000|Outcome|2 mg/kg GR MD 02|"GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions~GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3"
11238442|NCT02462967|OG001|Outcome|8 mg/kg GR MD 02|"GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions~GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3"
11238443|NCT02462967|OG002|Outcome|Placebo|"Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions~Placebo: Placebo for GR-MD-02"
11238444|NCT02462967|EG000|Reported Event|2 mg/kg GR MD 02|"GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions~GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3"
11238445|NCT02462967|EG001|Reported Event|8 mg/kg GR MD 02|"GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions~GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3"
11238446|NCT02462967|EG002|Reported Event|Placebo|"Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions~Placebo: Placebo for GR-MD-02"
11238447|NCT02463032|BG000|Baseline|GTx-024 9 mg|"Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg~GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate."
11238448|NCT02463032|BG001|Baseline|GTx-024 18 mg|"Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg~GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate."
11238449|NCT02463032|BG002|Baseline|Total|Total of all reporting groups
11238450|NCT02463032|FG000|Participant Flow|GTx-024 9 mg|"Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg~GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate."
11238451|NCT02463032|FG001|Participant Flow|GTx-024 18 mg|"Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg~GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate."
11238452|NCT02463032|OG000|Outcome|GTx-024 9 mg|"Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg~GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate."
11238453|NCT02463032|OG001|Outcome|GTx-024 18 mg|"Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg~GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate."
11238454|NCT02463032|EG000|Reported Event|GTx-024 9 mg|"Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg~GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate."
11238455|NCT02463032|EG001|Reported Event|GTx-024 18 mg|"Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg~GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate."
11238456|NCT02463071|BG000|Baseline|AZD0585 2g Group|AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
11238457|NCT02463071|BG001|Baseline|AZD0585 4g Group|AZD0585 1g × 4 capsules once daily
11238458|NCT02463071|BG002|Baseline|Placebo Control Group|AZD0585 placebo 1g × 4 capsules once daily
11238459|NCT02463071|BG003|Baseline|Total|Total of all reporting groups
11238460|NCT02463071|FG000|Participant Flow|AZD0585 2g Group|AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
11238461|NCT02463071|FG001|Participant Flow|AZD0585 4g Group|AZD0585 1g × 4 capsules once daily
11238462|NCT02463071|FG002|Participant Flow|Placebo Control Group|AZD0585 placebo 1g × 4 capsules once daily
11238463|NCT02463071|OG000|Outcome|AZD0585 2g Group|AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
11238464|NCT02463071|OG001|Outcome|AZD0585 4g Group|AZD0585 1g × 4 capsules once daily
11238465|NCT02463071|OG002|Outcome|Placebo Control Group|AZD0585 placebo 1g × 4 capsules once daily
11238466|NCT02463071|EG000|Reported Event|AZD0585 2g Group|AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
11238467|NCT02463071|EG001|Reported Event|AZD0585 4g Group|AZD0585 1g × 4 capsules once daily
11238468|NCT02463071|EG002|Reported Event|Placebo Control Group|AZD0585 placebo 1g × 4 capsules once daily
11238469|NCT02463097|BG000|Baseline|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
11238470|NCT02463097|FG000|Participant Flow|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
11238471|NCT02463097|OG000|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
11238472|NCT02463097|EG000|Reported Event|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
11238473|NCT02463227|BG000|Baseline|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
11238474|NCT02463227|FG000|Participant Flow|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
11238475|NCT02463227|OG000|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
11238476|NCT02463227|EG000|Reported Event|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
11359287|NCT03137225|BG001|Baseline|NAVA Then NIPPV Mode|"After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.~The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , at the same PEEP (positive end-expiratory pressure) and respiratory rate.~One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode."
11359288|NCT03137225|BG002|Baseline|Total|Total of all reporting groups
11359289|NCT03137225|FG000|Participant Flow|NIPPV Then NAVA Mode|"After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.~The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode.~These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, at the same PEEP (positive end-expiratory pressure) and respiratory rate.~One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA)"
11359290|NCT03137225|FG001|Participant Flow|NAVA Then NIPPV Mode|"After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.~The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , at the same PEEP (positive end-expiratory pressure) and respiratory rate.~One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode."
11359291|NCT03137225|OG000|Outcome|NIPPV Then NAVA Mode|"After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.~The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode.~These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, at the same PEEP (positive end-expiratory pressure) and respiratory rate.~One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA)"
11359292|NCT03137225|OG001|Outcome|NAVA Then NIPPV Mode|"After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.~The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , at the same PEEP (positive end-expiratory pressure) and respiratory rate.~One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode."
11359293|NCT03137225|EG000|Reported Event|NIPPV Then NAVA Mode|"After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.~The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode.~These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, at the same PEEP (positive end-expiratory pressure) and respiratory rate.~One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA)"
11359294|NCT03137225|EG001|Reported Event|NAVA Then NIPPV Mode|"After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.~The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , at the same PEEP (positive end-expiratory pressure) and respiratory rate.~One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode."
11359295|NCT03123393|BG000|Baseline|Cohort A: TAK-659 100 mg|TAK-659 100 mg tablet, orally, once daily (QD), during each 28-days cycle (median exposure was 41 days).
11359296|NCT03123393|BG001|Baseline|Cohort B: TAK-659 Ramp-up Dosing|TAK-659 60-100 mg tablet, orally, QD, dose based on safety and tolerability during each 28-days cycle (median exposure was 28 days).
11359297|NCT03123393|BG002|Baseline|Total|Total of all reporting groups
11359298|NCT03123393|FG000|Participant Flow|Cohort A: TAK-659 100 mg|TAK-659 100 mg tablet, orally, once daily (QD), during each 28-days cycle (median exposure was 41 days).
11359299|NCT03123393|FG001|Participant Flow|Cohort B: TAK-659 Ramp-up Dosing|TAK-659 60-100 mg tablet, orally, QD, dose based on safety and tolerability during each 28-days cycle (median exposure was 28 days).
11359300|NCT03123393|OG000|Outcome|Cohort A: TAK-659 100 mg|TAK-659 100 mg tablet, orally, once daily (QD), during each 28-days cycle (median exposure was 41 days).
11359301|NCT03123393|OG001|Outcome|Cohort B: TAK-659 Ramp-up Dosing|TAK-659 60-100 mg tablet, orally, QD, dose based on safety and tolerability during each 28-days cycle (median exposure was 28 days).
11359302|NCT03123393|EG000|Reported Event|Cohort A: TAK-659 100 mg|TAK-659 100 mg tablet, orally, once daily (QD), during each 28-days cycle (median exposure was 41 days).
11359303|NCT03123393|EG001|Reported Event|Cohort B: TAK-659 Ramp-up Dosing|TAK-659 60-100 mg tablet, orally, QD, dose based on safety and tolerability during each 28-days cycle (median exposure was 28 days).
11359304|NCT03123328|BG000|Baseline|Test Subjects|"Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU.~Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin."
11359305|NCT03123328|FG000|Participant Flow|Test Subjects|"Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU.~Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin."
11359306|NCT03123328|OG000|Outcome|Test Subjects|"Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU.~Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin."
11359307|NCT03123328|EG000|Reported Event|Test Subjects|"Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU.~Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin."
11359308|NCT03119662|BG000|Baseline|Visipaque™: Contrast-Enhanced Computed Tomography (CECT)|Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent CT examination.
11359309|NCT03119662|BG001|Baseline|Saline: Non-Enhanced Computed Tomography (NECT)|Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent CT examination and supplemental non-contrast duplex ultrasonography imaging examination.
11359310|NCT03119662|BG002|Baseline|Total|Total of all reporting groups
11359311|NCT03119662|FG000|Participant Flow|Visipaque™: Contrast-Enhanced Computed Tomography (CECT)|Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.
11359312|NCT03119662|FG001|Participant Flow|Saline: Non-Enhanced Computed Tomography (NECT)|Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent computed tomography (CT) examination and supplemental non-contrast duplex ultrasonography imaging examination.
11359313|NCT03119662|OG000|Outcome|Visipaque™: Contrast-Enhanced Computed Tomography (CECT)|Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent CT examination.
11359314|NCT03119662|OG001|Outcome|Saline: Non-Enhanced Computed Tomography (NECT)|Participants received 1 intravenous injection of saline placebo (matched to Visipaque™) and underwent CT examination and supplemental non-contrast duplex ultrasonography imaging examination.
11359315|NCT03119662|EG000|Reported Event|Visipaque™: Contrast-Enhanced Computed Tomography (CECT)|Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent CT examination.
11359316|NCT03119662|EG001|Reported Event|Saline: Non-Enhanced Computed Tomography (NECT)|Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent CT examination and supplemental non-contrast duplex ultrasonography imaging examination.
11359317|NCT03109418|BG000|Baseline|Control Group|"OSA patients will receive standard inhaled anesthesia with normal saline infusion~Control: OSA patients receiving standard inhaled anesthesia combined with normal saline"
11359318|NCT03109418|BG001|Baseline|Ketamine Group|"OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.~Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight"
11359319|NCT03109418|BG002|Baseline|Total|Total of all reporting groups
11359320|NCT03109418|FG000|Participant Flow|Control Group|"OSA patients will receive standard inhaled anesthesia with normal saline infusion~Control: OSA patients receiving standard inhaled anesthesia combined with normal saline"
11359321|NCT03109418|FG001|Participant Flow|Ketamine Group|"OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.~Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight"
11359322|NCT03109418|OG000|Outcome|Control Group|"OSA patients will receive standard inhaled anesthesia with normal saline infusion~Control: OSA patients receiving standard inhaled anesthesia combined with normal saline"
11359323|NCT03109418|OG001|Outcome|Ketamine Group|"OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.~Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight"
11359324|NCT03109418|EG000|Reported Event|Control Group|"OSA patients will receive standard inhaled anesthesia with normal saline infusion~Control: OSA patients receiving standard inhaled anesthesia combined with normal saline"
11359325|NCT03109418|EG001|Reported Event|Ketamine Group|"OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.~Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight"
11359326|NCT03120676|BG000|Baseline|Atezolizumab|"Treatment will be Atezolizumab administered at 1200 mg IV every 3 weeks. A cycle is defined as 3 weeks of therapy. Therapy will continue until disease progression, intolerable toxicities or death for a maximum duration of treatment of 36 cycles.~Atezolizumab: All patients will receive atezolizumab 1200 mg via IV infusion on D1 of each 21-day cycle."
11359327|NCT03120676|FG000|Participant Flow|Atezolizumab|"Treatment will be Atezolizumab administered at 1200 mg IV every 3 weeks. A cycle is defined as 3 weeks of therapy. Therapy will continue until disease progression, intolerable toxicities or death for a maximum duration of treatment of 36 cycles.~Atezolizumab: All patients will receive atezolizumab 1200 mg via IV infusion on D1 of each 21-day cycle."
11359328|NCT03120676|OG000|Outcome|Atezolizumab|"Treatment will be Atezolizumab administered at 1200 mg IV every 3 weeks. A cycle is defined as 3 weeks of therapy. Therapy will continue until disease progression, intolerable toxicities or death for a maximum duration of treatment of 36 cycles.~Atezolizumab: All patients will receive atezolizumab 1200 mg via IV infusion on D1 of each 21-day cycle."
11359329|NCT03120676|EG000|Reported Event|Atezolizumab|"Treatment will be Atezolizumab administered at 1200 mg IV every 3 weeks. A cycle is defined as 3 weeks of therapy. Therapy will continue until disease progression, intolerable toxicities or death for a maximum duration of treatment of 36 cycles.~Atezolizumab: All patients will receive atezolizumab 1200 mg via IV infusion on D1 of each 21-day cycle."
11359330|NCT03109873|BG000|Baseline|Arm I (EBRT, Metformin Hydrochloride)|"Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.~External Beam Radiation Therapy: Undergo External Beam Radiation Therapy~Metformin Hydrochloride: Given orally"
11359331|NCT03109873|BG001|Baseline|Arm II (EBRT, Placebo)|"Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.~External Beam Radiation Therapy: Undergo External Beam Radiation Therapy~Placebo: Given orally"
11359332|NCT03109873|BG002|Baseline|Total|Total of all reporting groups
11359333|NCT03109873|FG000|Participant Flow|Arm I (EBRT, Metformin Hydrochloride)|"Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.~External Beam Radiation Therapy: Undergo External Beam Radiation Therapy~Metformin Hydrochloride: Given orally"
11359334|NCT03109873|FG001|Participant Flow|Arm II (EBRT, Placebo)|"Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.~External Beam Radiation Therapy: Undergo External Beam Radiation Therapy~Placebo: Given orally"
11359335|NCT03109873|OG000|Outcome|Arm I (EBRT, Metformin Hydrochloride)|"Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.~External Beam Radiation Therapy: Undergo External Beam Radiation Therapy~Metformin Hydrochloride: Given orally"
11359336|NCT03109873|OG001|Outcome|Arm II (EBRT, Placebo)|"Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.~External Beam Radiation Therapy: Undergo External Beam Radiation Therapy~Placebo: Given orally"
11359337|NCT03109873|EG000|Reported Event|Arm I (EBRT, Metformin Hydrochloride)|"Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.~External Beam Radiation Therapy: Undergo External Beam Radiation Therapy~Metformin Hydrochloride: Given orally"
11359338|NCT03109873|EG001|Reported Event|Arm II (EBRT, Placebo)|"Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.~External Beam Radiation Therapy: Undergo External Beam Radiation Therapy~Placebo: Given orally"
11359339|NCT03100617|BG000|Baseline|REACH-VA Family Caregiver Intervention|"Behavioral intervention with several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction.~Psychosocial caregiver intervention: Modified version of the REACH-VA intervention for family caregivers of persons with dementia. The intervention has several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction."
11359340|NCT03100617|FG000|Participant Flow|Treatment|This group received the REACH-VA intervention
11359341|NCT03100617|OG000|Outcome|Treatment|This group received the REACH-VA intervention
11359342|NCT03100617|EG000|Reported Event|Treatment|Behavioral intervention
11359343|NCT03115853|BG000|Baseline|All Participants|
11359344|NCT03115853|FG000|Participant Flow|All Participants|all participants enrolled in the study
11359345|NCT03115853|OG000|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
11359346|NCT03115853|OG001|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
11359347|NCT03115853|OG002|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
11359348|NCT03115853|EG000|Reported Event|All Participants|
11359349|NCT03113071|BG000|Baseline|Newly Diagnosed AML/MDS|"For Group#1 a total of 37 patients with newly diagnosed MDL or MDS will be enrolled, including the eligible patients originally enrolled in the phase Ib portion (safe dose group) of the study, with the goal of determining the clinical activity of our experimental regimen. In the phase II segment, all new patients who are enrolled will initially be randomized in a 1 to 1 fashion to receive decitabine alone or decitabine plus digoxin for one cycle before receiving decitabine plus digoxin for all subsequent cycles for a total of 6 cycles.~Decitabine: Decitabine will be administered in combination with Digoxin~Digoxin: Decitabine will be administered in combination with Digoxin"
11359350|NCT03113071|BG001|Baseline|Refractory or Relapsed AML/MDS|"or Group#2 the target will be to enroll a total of 60 patients with relapsed or refractory AML/MDS, including the eligible patients enrolled in the phase Ib group. This group will have randomization and treatments similar to Group#1.~Decitabine: Decitabine will be administered in combination with Digoxin~Digoxin: Decitabine will be administered in combination with Digoxin"
11359351|NCT03113071|BG002|Baseline|Total|Total of all reporting groups
10962017|NCT00864123|BG001|Baseline|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
11238477|NCT02463331|BG000|Baseline|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
11238478|NCT02463331|BG001|Baseline|Azathioprine Plus Prednisone|"azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
11238479|NCT02463331|BG002|Baseline|Total|Total of all reporting groups
11238480|NCT02463331|FG000|Participant Flow|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
11238481|NCT02463331|FG001|Participant Flow|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
11238482|NCT02463331|OG000|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
11238483|NCT02463331|OG001|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
11238484|NCT02463331|EG000|Reported Event|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
11238485|NCT02463331|EG001|Reported Event|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
11238486|NCT02463357|BG000|Baseline|Quercetin|"Quercetin: 500mg pill, twice daily for 5 days~Quercetin"
11238487|NCT02463357|BG001|Baseline|Nifedipine+Methazolamide|"Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days~Nifedipine extended release~Methazolamide"
11238488|NCT02463357|BG002|Baseline|Metformin|"Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)~Metformin"
11238489|NCT02463357|BG003|Baseline|Placebo|"Sugar pill manufactured to look like all other investigational products~Placebo"
10962018|NCT00864123|BG002|Baseline|Total|Total of all reporting groups
11238490|NCT02463357|BG004|Baseline|Nitrite|"Nitrite: 20mg pill, three times daily for 5 days~Nitrite"
11238491|NCT02463357|BG005|Baseline|Total|Total of all reporting groups
11238492|NCT02463357|FG000|Participant Flow|Quercetin|"Quercetin: 500mg pill, twice daily for 5 days~Quercetin"
11238493|NCT02463357|FG001|Participant Flow|Nifedipine+Methazolamide|"Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days~Nifedipine extended release~Methazolamide"
11238494|NCT02463357|FG002|Participant Flow|Metformin|"Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)~Metformin"
11238495|NCT02463357|FG003|Participant Flow|Placebo|"Sugar pill manufactured to look like all other investigational products~Placebo"
11238496|NCT02463357|FG004|Participant Flow|Nitrite|"Nitrite: 20mg pill, three times daily for 5 days~Nitrite"
11238497|NCT02463357|OG000|Outcome|Quercetin|"Quercetin: 500mg pill, twice daily for 5 days~Quercetin"
11238498|NCT02463357|OG001|Outcome|Nifedipine+Methazolamide|"Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days~Nifedipine extended release~Methazolamide"
11238499|NCT02463357|OG002|Outcome|Metformin|"Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)~Metformin"
11238500|NCT02463357|OG003|Outcome|Placebo|"Sugar pill manufactured to look like all other investigational products~Placebo"
11238501|NCT02463357|OG004|Outcome|Nitrite|"Nitrite: 20mg pill, three times daily for 5 days~Nitrite"
11238502|NCT02463357|EG000|Reported Event|Quercetin|"Quercetin: 500mg pill, twice daily for 5 days~Quercetin"
11238503|NCT02463357|EG001|Reported Event|Nifedipine+Methazolamide|"Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days~Nifedipine extended release~Methazolamide"
11238504|NCT02463357|EG002|Reported Event|Metformin|"Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)~Metformin"
11238505|NCT02463357|EG003|Reported Event|Placebo|"Sugar pill manufactured to look like all other investigational products~Placebo"
11238506|NCT02463357|EG004|Reported Event|Nitrite|"Nitrite: 20mg pill, three times daily for 5 days~Nitrite"
11238507|NCT02463409|BG000|Baseline|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
11238508|NCT02463409|FG000|Participant Flow|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
11238509|NCT02463409|OG000|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
11238510|NCT02463409|EG000|Reported Event|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline. All patients who enrolled in the study are included in this group (excluding screen fails)."
11238511|NCT02463487|BG000|Baseline|Cardinal Pro (NPWT) Therapy|"Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation~Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface"
11186939|NCT02103478|OG002|Outcome|Phase 1 Dose Escalation Cohort 3|Starting cohort was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186940|NCT02103478|OG003|Outcome|Phase 1 Dose Escalation Cohort 4|Starting cohort was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186941|NCT02103478|OG004|Outcome|Phase 1 Dose Escalation Cohort 5|Starting cohort was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186942|NCT02103478|EG000|Reported Event|Phase 1 Dose Escalation Cohort 1|Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186943|NCT02103478|EG001|Reported Event|Phase 1 Dose Escalation Cohort 2|Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186944|NCT02103478|EG002|Reported Event|Phase 1 Dose Escalation Cohort 3|Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186945|NCT02103478|EG003|Reported Event|Phase 1 Dose Escalation Cohort 4|Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186946|NCT02103478|EG004|Reported Event|Phase 1 Dose Escalation Cohort 5|Cohort 1 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
11186947|NCT02103478|EG005|Reported Event|Phase 2 Dose Confirmation|Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186948|NCT02103478|EG006|Reported Event|Phase 2 Fixed-Dose Combination|Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
11186949|NCT02103608|BG000|Baseline|Glide Device|Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
11186950|NCT02103608|FG000|Participant Flow|Glide Device|Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
11186951|NCT02103608|OG000|Outcome|Glide Device|Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
11186952|NCT02103608|EG000|Reported Event|Glide Device|Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
11186953|NCT02103816|BG000|Baseline|SmartLipo Triplex Laser System Along With the SideLaze800 Hand|SmartLipo Triplex laser system along with the SideLaze800 hand piece
11186954|NCT02103816|FG000|Participant Flow|SmartLipo Triplex Laser System Along With the SideLaze800 Hand|SmartLipo Triplex laser system along with the SideLaze800 hand piece
11186955|NCT02103816|OG000|Outcome|SmartLipo Triplex Laser System Along With the SideLaze800 Hand|SmartLipo Triplex laser system along with the SideLaze800 hand piece
11186956|NCT02103816|EG000|Reported Event|SmartLipo Triplex Laser System Along With the SideLaze800 Hand|SmartLipo Triplex laser system along with the SideLaze800 hand piece
11186957|NCT02103855|BG000|Baseline|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
11186958|NCT02103855|FG000|Participant Flow|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
11186959|NCT02103855|OG000|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
11359352|NCT03113071|FG000|Participant Flow|Newly Diagnosed AML/MDS|"For Group#1 a total of 37 patients with newly diagnosed MDL or MDS will be enrolled, including the eligible patients originally enrolled in the phase Ib portion (safe dose group) of the study, with the goal of determining the clinical activity of our experimental regimen. In the phase II segment, all new patients who are enrolled will initially be randomized in a 1 to 1 fashion to receive decitabine alone or decitabine plus digoxin for one cycle before receiving decitabine plus digoxin for all subsequent cycles for a total of 6 cycles.~Decitabine: Decitabine will be administered in combination with Digoxin~Digoxin: Decitabine will be administered in combination with Digoxin"
11359353|NCT03113071|FG001|Participant Flow|Refractory or Relapsed AML/MDS|"or Group#2 the target will be to enroll a total of 60 patients with relapsed or refractory AML/MDS, including the eligible patients enrolled in the phase Ib group. This group will have randomization and treatments similar to Group#1.~Decitabine: Decitabine will be administered in combination with Digoxin~Digoxin: Decitabine will be administered in combination with Digoxin"
11359354|NCT03113071|OG000|Outcome|Newly Diagnosed AML/MDS|"For Group#1 a total of 37 patients with newly diagnosed MDL or MDS will be enrolled, including the eligible patients originally enrolled in the phase Ib portion (safe dose group) of the study, with the goal of determining the clinical activity of our experimental regimen. In the phase II segment, all new patients who are enrolled will initially be randomized in a 1 to 1 fashion to receive decitabine alone or decitabine plus digoxin for one cycle before receiving decitabine plus digoxin for all subsequent cycles for a total of 6 cycles.~Decitabine: Decitabine will be administered in combination with Digoxin~Digoxin: Decitabine will be administered in combination with Digoxin"
11359355|NCT03113071|OG001|Outcome|Refractory or Relapsed AML/MDS|"or Group#2 the target will be to enroll a total of 60 patients with relapsed or refractory AML/MDS, including the eligible patients enrolled in the phase Ib group. This group will have randomization and treatments similar to Group#1.~Decitabine: Decitabine will be administered in combination with Digoxin~Digoxin: Decitabine will be administered in combination with Digoxin"
11359356|NCT03113071|EG000|Reported Event|Newly Diagnosed AML/MDS|"For Group#1 a total of 37 patients with newly diagnosed MDL or MDS will be enrolled, including the eligible patients originally enrolled in the phase Ib portion (safe dose group) of the study, with the goal of determining the clinical activity of our experimental regimen. In the phase II segment, all new patients who are enrolled will initially be randomized in a 1 to 1 fashion to receive decitabine alone or decitabine plus digoxin for one cycle before receiving decitabine plus digoxin for all subsequent cycles for a total of 6 cycles.~Decitabine: Decitabine will be administered in combination with Digoxin~Digoxin: Decitabine will be administered in combination with Digoxin"
11359357|NCT03113071|EG001|Reported Event|Refractory or Relapsed AML/MDS|"or Group#2 the target will be to enroll a total of 60 patients with relapsed or refractory AML/MDS, including the eligible patients enrolled in the phase Ib group. This group will have randomization and treatments similar to Group#1.~Decitabine: Decitabine will be administered in combination with Digoxin~Digoxin: Decitabine will be administered in combination with Digoxin"
11359358|NCT03110900|BG000|Baseline|Haloperidol + Lorazepam|"IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler~Haloperidol + lorazepam: Haloperidol + lorazepam + placebo"
11359359|NCT03110900|BG001|Baseline|Loxapine|"Inhaled loxapine 10mg + IM normal saline~Loxapine: loxapine + placebo"
11359360|NCT03110900|BG002|Baseline|Total|Total of all reporting groups
11359361|NCT03110900|FG000|Participant Flow|Haloperidol + Lorazepam|"IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler~Haloperidol + lorazepam: Haloperidol + lorazepam + placebo"
11359362|NCT03110900|FG001|Participant Flow|Loxapine|"Inhaled loxapine 10mg + IM normal saline~Loxapine: loxapine + placebo"
11359363|NCT03110900|OG000|Outcome|Haloperidol + Lorazepam|"IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler~Haloperidol + lorazepam: Haloperidol + lorazepam + placebo"
11359364|NCT03110900|OG001|Outcome|Loxapine|"Inhaled loxapine 10mg + IM normal saline~Loxapine: loxapine + placebo"
11359365|NCT03110900|EG000|Reported Event|Haloperidol + Lorazepam|"IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler~Haloperidol + lorazepam: Haloperidol + lorazepam + placebo"
10962019|NCT00864123|FG000|Participant Flow|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
11186960|NCT02103855|EG000|Reported Event|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
11186961|NCT02104141|BG000|Baseline|Operated Subjects|ROIA Interbody Cage with VerteBRIDGE plating
11186962|NCT02104141|FG000|Participant Flow|Operated Subjects|ROIA Interbody Cage with VerteBRIDGE plating
11186963|NCT02104141|OG000|Outcome|Operated Subjects|ROIA Interbody Cage with VerteBRIDGE plating
11186964|NCT02104141|EG000|Reported Event|Operated Subjects|ROIA Interbody Cage with VerteBRIDGE plating
11186965|NCT02104167|BG000|Baseline|Operated Subjects With ROI-C Device|Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
11186966|NCT02104167|FG000|Participant Flow|Operated Subjects With ROI-C Device|Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
11186967|NCT02104167|OG000|Outcome|Operated Subjects With ROI-C Device|Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
11186968|NCT02104167|EG000|Reported Event|Operated Subjects With ROI-C Device|Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
11186969|NCT02104219|BG000|Baseline|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
11186970|NCT02104219|FG000|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
11186971|NCT02104219|OG000|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
11186972|NCT02104219|EG000|Reported Event|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
11186973|NCT02104414|BG000|Baseline|Exparel|266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
11186974|NCT02104414|BG001|Baseline|Bupivacaine HCl With Epinephrine|75mg/30mL 0.25% Bupivacaine HCl with epinephrine
11186975|NCT02104414|BG002|Baseline|Normal Saline|30mL Normal Saline
11186976|NCT02104414|BG003|Baseline|Total|Total of all reporting groups
11186977|NCT02104414|FG000|Participant Flow|Exparel|266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
11186978|NCT02104414|FG001|Participant Flow|Bupivacaine HCl With Epinephrine|75mg/30mL 0.25% Bupivacaine HCl with epinephrine
11186979|NCT02104414|FG002|Participant Flow|Normal Saline|30mL Normal Saline
11186980|NCT02104414|OG000|Outcome|Exparel|266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
11186981|NCT02104414|OG001|Outcome|Bupivacaine HCl With Epinephrine|75mg/30mL 0.25% Bupivacaine HCl with epinephrine
11186982|NCT02104414|OG002|Outcome|Normal Saline|30mL Normal Saline
11186983|NCT02104414|EG000|Reported Event|Exparel|266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
11186984|NCT02104414|EG001|Reported Event|Bupivacaine HCl With Epinephrine|75mg/30mL 0.25% Bupivacaine HCl with epinephrine
11186985|NCT02104414|EG002|Reported Event|Normal Saline|30mL Normal Saline
11186986|NCT02104427|BG000|Baseline|TG-0054 Combined With G-CSF|1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal.
11186987|NCT02104427|FG000|Participant Flow|TG-0054 Combined With G-CSF|1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal.
11186988|NCT02104427|OG000|Outcome|Within 1 Leukapheresis Session|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 1 leukapheresis session
11186989|NCT02104427|OG001|Outcome|Within 2 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 2 leukapheresis session
11186990|NCT02104427|OG002|Outcome|Within 3 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 3 leukapheresis session
11186991|NCT02104427|OG003|Outcome|Within 4 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 4 leukapheresis session
11186992|NCT02104427|OG000|Outcome|Within 1 Leukapheresis Session|Cumulative CD34+ cell counts ≥2.5 x 10^6 cells/kg within 1 leukapheresis session
11359366|NCT03110900|EG001|Reported Event|Loxapine|"Inhaled loxapine 10mg + IM normal saline~Loxapine: loxapine + placebo"
11186993|NCT02104427|OG001|Outcome|Within 2 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥2.5 x 10^6 cells/kg within 2 leukapheresis session
11186994|NCT02104427|OG002|Outcome|Within 3 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥2.5 x 10^6 cells/kg within 3 leukapheresis session
11186995|NCT02104427|OG000|Outcome|Within 1 Leukapheresis Session|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 1 leukapheresis session
11186996|NCT02104427|OG001|Outcome|Within 2 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 2 leukapheresis session
11186997|NCT02104427|OG002|Outcome|Within 3 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 3 leukapheresis session
11186998|NCT02104427|OG003|Outcome|Within 4 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 4 leukapheresis session
11186999|NCT02104427|OG004|Outcome|Within 5 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 5 leukapheresis session
11187000|NCT02104427|OG000|Outcome|Pre-dose|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-dose timepoint
11187001|NCT02104427|OG001|Outcome|4h Post-infusion|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at 4h post-infusion timepoint
11187002|NCT02104427|OG002|Outcome|6h Post-infusion|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at 6h post-infusion timepoint
11187003|NCT02104427|OG003|Outcome|Pre-leukapheresis|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-leukapheresis timepoint
11187004|NCT02104427|OG004|Outcome|Post-leukapheresis|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Post-leukapheresis timepoint
11187005|NCT02104427|EG000|Reported Event|10 µg/kg/Day G-CSF Alone|Days 1 through 4
11187006|NCT02104427|EG001|Reported Event|10 µg/kg/Day G-CSF + 3.14 mg/kg TG-0054|Day 5 until end of study
11187007|NCT02104427|EG002|Reported Event|Overall|
11187008|NCT02104505|BG000|Baseline|Gamma Tocopherol (14 Days) Then Placebo (14 Days)|Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days, washout for minimum 3 weeks, then Safflower oil capsules x 14 days
11187009|NCT02104505|BG001|Baseline|Placebo (14 Days) Then Gamma Tocopherol (14 Days)|Safflower oil capsules x 14 days, washout for minimum 3 weeks, then Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days
11187010|NCT02104505|BG002|Baseline|Total|Total of all reporting groups
11187011|NCT02104505|FG000|Participant Flow|Gamma Tocopherol (14 Days) Then Placebo (14 Days)|Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days, washout for minimum 3 weeks, then Safflower oil capsules x 14 days
11187012|NCT02104505|FG001|Participant Flow|Placebo (14 Days) Then Gamma Tocopherol (14 Days)|Safflower oil capsules x 14 days, washout for minimum 3 weeks, then Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days
11187013|NCT02104505|OG000|Outcome|Gamma Tocopherol|Gamma Tocopherol 700 mg capsules,: 2 capsules daily for 14 days
11187014|NCT02104505|OG001|Outcome|Placebo|700 mg Safflower oil capsules; 2 capsules daily for 14 days
11359367|NCT03078868|BG000|Baseline|Single-point Intervention|"magnetic resonance scanner~Magnetic Resonance Scanner: MRI"
11359368|NCT03078868|FG000|Participant Flow|Single-point Intervention|"magnetic resonance scanner~Magnetic Resonance Scanner: MRI"
11359369|NCT03078868|OG000|Outcome|Single-point Intervention|"magnetic resonance scanner~Magnetic Resonance Scanner: MRI"
11359370|NCT03078868|EG000|Reported Event|Single-point Intervention|"magnetic resonance scanner~Magnetic Resonance Scanner: MRI"
11359371|NCT03078270|BG000|Baseline|Open-label|4 participants were recruited with social anxiety disorder.
11359372|NCT03078270|BG001|Baseline|Double-Blind|No participants were recruited.
11359373|NCT03078270|BG002|Baseline|Total|Total of all reporting groups
11359374|NCT03078270|FG000|Participant Flow|Open-label|4 participants were recruited for the open-label study.
11359375|NCT03078270|FG001|Participant Flow|Double-Blind|0 participants were recruited for the double-blind, comparison study.
11359376|NCT03078270|OG000|Outcome|Open-label|"10 participants will be recruited for an open-label study. All will receive the active medication and complete depression and anxiety surveys at baseline, 4-weeks, and 8-weeks post injection. All participants will receive botulinum toxin A.~botulinum toxin A: Single treatment visit for 5 injections of botulinum toxin A, 40 units (for females) and 50 units (for males)/"
11359377|NCT03078270|OG001|Outcome|Double-Blind|"30 participants will be recruited for a double-blind, comparison study. Participants will be randomized to the active or control groups. Each will receive an injection (active medication or placebo) and will complete a depression and anxiety survey at baseline, 4-weeks and 8-weeks post injection. Participants in the active group will receive botulinum toxin A; participants in the control group will receive a placebo.~botulinum toxin A: Single treatment visit for 5 injections of botulinum toxin A, 40 units (for females) and 50 units (for males)/~Placebo: single treatment visit for 5 injections of normal saline"
11359378|NCT03078270|EG000|Reported Event|Open-label|4 participants were recruited for the open-label study.
10962020|NCT00864123|FG001|Participant Flow|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
11359379|NCT03078270|EG001|Reported Event|Double-Blind|0 participants were recruited for the double-blind, comparison study.
11359380|NCT03065933|BG000|Baseline|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
11359381|NCT03065933|FG000|Participant Flow|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
11359382|NCT03065933|OG000|Outcome|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
11359383|NCT03065933|EG000|Reported Event|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
11359384|NCT03070002|BG000|Baseline|Treatment (Denosumab)|"Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.~Denosumab: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11359385|NCT03070002|FG000|Participant Flow|Treatment (Denosumab)|"Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.~Denosumab: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11359386|NCT03070002|OG000|Outcome|Treatment (Denosumab)|"Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.~Denosumab: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11359387|NCT03070002|EG000|Reported Event|Treatment (Denosumab)|"Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.~Denosumab: Given SC~Laboratory Biomarker Analysis: Correlative studies"
11359388|NCT03058705|BG000|Baseline|Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)|"Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.~Hexaminolevulinate HCL: Intravesical instillation of 100 mg hexaminolevulinate HCL will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Hexaminolevulinate has a favorable safety profile at this dose."
11359389|NCT03058705|FG000|Participant Flow|Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)|"Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.~Hexaminolevulinate HCL: Intravesical instillation of 100 mg hexaminolevulinate HCL will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Hexaminolevulinate has a favorable safety profile at this dose."
11359390|NCT03058705|OG000|Outcome|Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)|"Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.~Hexaminolevulinate HCL: Intravesical instillation of 100 mg hexaminolevulinate HCL will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Hexaminolevulinate has a favorable safety profile at this dose."
11187015|NCT02104505|OG000|Outcome|Gamma Tocopherol|Gamma Tocopherol 700 mg capsules: 2 capsules daily for 14 days
11187016|NCT02104505|EG000|Reported Event|Gamma Tocopherol|Gamma Tocopherol 700 mg capsules; 2 capsules daily for 14 days
11187017|NCT02104505|EG001|Reported Event|Placebo|700 mg Safflower oil capsules; 2 capsules daily for 14 days
11187018|NCT02104557|BG000|Baseline|Sayana|Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.
11187019|NCT02104557|FG000|Participant Flow|Sayana|Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.
11187020|NCT02104557|OG000|Outcome|Sayana|Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.
11187021|NCT02104557|EG000|Reported Event|Sayana|Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.
11187022|NCT02104583|BG000|Baseline|Cohort 1 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
11187023|NCT02104583|BG001|Baseline|Cohort 1 Placebo|Participants received single loading dose of placebo to match eleclazine tablets On Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months
11187024|NCT02104583|BG002|Baseline|Cohort 2 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
11187025|NCT02104583|BG003|Baseline|Cohort 2 Eleclazine 6 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
11187026|NCT02104583|BG004|Baseline|Cohort 2 Placebo|Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
11187027|NCT02104583|BG005|Baseline|Total|Total of all reporting groups
11187028|NCT02104583|FG000|Participant Flow|Cohort 1 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
11187029|NCT02104583|FG001|Participant Flow|Cohort 1 Placebo|Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
11187030|NCT02104583|FG002|Participant Flow|Cohort 2 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
11187031|NCT02104583|FG003|Participant Flow|Cohort 2 Eleclazine 6 mg|Participants were randomized to receive single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
11187032|NCT02104583|FG004|Participant Flow|Cohort 2 Placebo|Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
11187033|NCT02104583|OG000|Outcome|Cohort 1 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
11187034|NCT02104583|OG001|Outcome|Cohort 1 Placebo|Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
11187035|NCT02104583|OG002|Outcome|Cohort 2 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
11187036|NCT02104583|OG003|Outcome|Cohort 2 Eleclazine 6 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
11187037|NCT02104583|OG004|Outcome|Cohort 2 Placebo|Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
11187038|NCT02104583|OG005|Outcome|Cohorts 1 and 2, Eleclazine 3 mg|All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
11187039|NCT02104583|OG006|Outcome|Cohorts 1 and 2, Placebo|All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
11187040|NCT02104583|OG006|Outcome|Cohorts 1 and 2, Placebo|All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months
11187041|NCT02104583|OG001|Outcome|Cohort 1 Placebo|Participants received single loading dose of placebo to match eleclazine tabletson Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
11187042|NCT02104583|OG000|Outcome|Cohort 2 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
11187043|NCT02104583|OG001|Outcome|Cohort 2 Eleclazine 6 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
11187044|NCT02104583|OG002|Outcome|Cohort 2 Placebo|Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
11187045|NCT02104583|OG003|Outcome|Cohorts 1 and 2, Eleclazine 3 mg|All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
11359391|NCT03058705|EG000|Reported Event|Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)|"Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.~Hexaminolevulinate HCL: Intravesical instillation of 100 mg hexaminolevulinate HCL will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Hexaminolevulinate has a favorable safety profile at this dose."
11359392|NCT03061279|BG000|Baseline|Acutrak Fixation|Fixation by Acutrak headless screw: The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating
11359393|NCT03061279|BG001|Baseline|Standard of Care Fixation|Fixation by headed screws, plates, and or wires: DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.
11359394|NCT03061279|BG002|Baseline|Total|Total of all reporting groups
11359395|NCT03061279|FG000|Participant Flow|Acutrak Fixation|Fixation by Acutrak headless screw: The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating
11359396|NCT03061279|FG001|Participant Flow|Standard of Care Fixation|Fixation by headed screws, plates, and or wires: DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.
10962021|NCT00864123|OG000|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
10962022|NCT00864123|OG001|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
10962023|NCT00864123|EG000|Reported Event|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
10962024|NCT00864123|EG001|Reported Event|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
10962025|NCT00864253|BG000|Baseline|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
11359397|NCT03061279|OG000|Outcome|Acutrak Fixation|Fixation by Acutrak headless screw: The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating
10962026|NCT00864253|BG001|Baseline|Dacarbazine Arm B 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
10962027|NCT00864253|BG002|Baseline|Total|Total of all reporting groups
10962028|NCT00864253|FG000|Participant Flow|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
10962029|NCT00864253|FG001|Participant Flow|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
10962030|NCT00864253|OG000|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 every 4 weeks
10962031|NCT00864253|OG001|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
11187046|NCT02104583|OG004|Outcome|Cohorts 1 and 2, Placebo|All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
11187047|NCT02104583|EG000|Reported Event|Cohort 1 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
10962032|NCT00864253|OG000|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
10962033|NCT00864253|OG001|Outcome|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
10962034|NCT00864253|EG000|Reported Event|ABI-007 Arm A|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
10962035|NCT00864253|EG001|Reported Event|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
11359398|NCT03061279|OG001|Outcome|Standard of Care Fixation|Fixation by headed screws, plates, and or wires: DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.
11359399|NCT03061279|EG000|Reported Event|Acutrak Fixation|Fixation by Acutrak headless screw: The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating
11359400|NCT03061279|EG001|Reported Event|Standard of Care Fixation|Fixation by headed screws, plates, and or wires: DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.
11359401|NCT03040323|BG000|Baseline|Biopsy With Lumason|Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy
11359402|NCT03040323|BG001|Baseline|Biopsy With Placebos|Placebos injected prior to ultrasound-guided biopsy.
11359403|NCT03040323|BG002|Baseline|Total|Total of all reporting groups
11359404|NCT03040323|FG000|Participant Flow|Biopsy With Lumason|Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy
11359405|NCT03040323|FG001|Participant Flow|Biopsy With Placebos|Placebos injected prior to ultrasound-guided biopsy.
11359406|NCT03040323|OG000|Outcome|Biopsy With Lumason|Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy;
11359407|NCT03040323|OG001|Outcome|Biopsy With Placebos|Placebos injected prior to ultrasound-guided biopsy
11359408|NCT03040323|EG000|Reported Event|Biopsy With Lumason|Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy;
11359409|NCT03040323|EG001|Reported Event|Biopsy With Placebos|Placebos injected prior to ultrasound-guided biopsy.
11359410|NCT03053518|BG000|Baseline|Life Style + Metformin|"Abbott Freestyle Libre Pro: A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.~LifeStyle: Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods."
11359411|NCT03053518|FG000|Participant Flow|Life Style + Metformin|"Abbott Freestyle Libre Pro: A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.~LifeStyle: Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods."
11359412|NCT03053518|OG000|Outcome|Life Style + Metformin|"Abbott Freestyle Libre Pro: A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.~LifeStyle: Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods."
11359413|NCT03053518|EG000|Reported Event|Life Style + Metformin|"Abbott Freestyle Libre Pro: A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.~LifeStyle: Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods."
11359414|NCT03050398|BG000|Baseline|Ribociclib + Letrozole|ribociclib with letrozole
11359415|NCT03050398|FG000|Participant Flow|Ribociclib + Letrozole|ribociclib with letrozole
11359416|NCT03050398|OG000|Outcome|Ribociclib + Letrozole|ribociclib with letrozole
11359417|NCT03050398|EG000|Reported Event|Ribociclib + Letrozole|ribociclib with letrozole
11359418|NCT03042780|BG000|Baseline|FOLFIRINOX Treatment|Participants will receive modified FOLFIRINOX which consists of 85 mg/m^2 of oxaliplatin, 400 mg/m^2 of leucovorin over the first 2 hours, 165 mg/m^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m^2. A cycle will be repeated every 14 days. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.
11359419|NCT03042780|FG000|Participant Flow|FOLFIRINOX Treatment|"Participants will receive modified FOLFIRINOX which consists of 85 mg/m^2 of oxaliplatin, 400 mg/m^2 of leucovorin over the first 2 hours, 165 mg/m^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle. Participants will undergo re-staging studies every 8 weeks. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.~FOLFIRINOX: The FOLFIRINOX regimen consists of oxaliplatin given as a 2-hour intravenous infusion, immediately followed by leucovorin given as a 2-hour intra-venous infusion, with the addition, after 30 minutes, of irinotecan given as a 90-minute intravenous infusion. This study treatment is immediately followed by a continuous intravenous infusion of 5-Fluorouracil (5-FU) over a 46-hour period"
11359420|NCT03042780|OG000|Outcome|FOLFIRINOX Treatment|"Participants will receive modified FOLFIRINOX which consists of 85 mg/m^2 of oxaliplatin, 400 mg/m^2 of leucovorin over the first 2 hours, 165 mg/m^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle. Participants will undergo re-staging studies every 8 weeks. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.~FOLFIRINOX: The FOLFIRINOX regimen consists of oxaliplatin given as a 2-hour intravenous infusion, immediately followed by leucovorin given as a 2-hour intra-venous infusion, with the addition, after 30 minutes, of irinotecan given as a 90-minute intravenous infusion. This study treatment is immediately followed by a continuous intravenous infusion of 5-Fluorouracil (5-FU) over a 46-hour period"
11187048|NCT02104583|EG001|Reported Event|Cohort 1 Placebo|Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
11359421|NCT03042780|EG000|Reported Event|FOLFIRINOX Treatment|Participants received modified FOLFIRINOX which consists of 85 mg/m^2 of oxaliplatin, 400 mg/m^2 of leucovorin over the first 2 hours, 165 mg/m^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle.
11359422|NCT03053960|BG000|Baseline|Diagnostic (Helical CT, PET/CT, MRI, CBCT)|"Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.~Computed Tomography: Undergo helical CT scan~Positron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan~Cone-Beam Computed Tomography: Undergo CBCT scan~Magnetic Resonance Imaging: Undergo MRI scan~Therapeutic Conventional Surgery: Undergo resection of tumor~Histopathologic Examination: Correlative studies"
11359423|NCT03053960|FG000|Participant Flow|Diagnostic (Helical CT, PET/CT, MRI, CBCT)|"Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.~Computed Tomography: Undergo helical CT scan~Positron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan~Cone-Beam Computed Tomography: Undergo CBCT scan~Magnetic Resonance Imaging: Undergo MRI scan~Therapeutic Conventional Surgery: Undergo resection of tumor~Histopathologic Examination: Correlative studies"
11359424|NCT03053960|OG000|Outcome|Diagnostic (Helical CT, PET/CT, MRI, CBCT)|"Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.~Computed Tomography: Undergo helical CT scan~Positron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan~Cone-Beam Computed Tomography: Undergo CBCT scan~Magnetic Resonance Imaging: Undergo MRI scan~Therapeutic Conventional Surgery: Undergo resection of tumor~Histopathologic Examination: Correlative studies"
11359425|NCT03053960|EG000|Reported Event|Diagnostic (Helical CT, PET/CT, MRI, CBCT)|"Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.~Computed Tomography: Undergo helical CT scan~Positron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan~Cone-Beam Computed Tomography: Undergo CBCT scan~Magnetic Resonance Imaging: Undergo MRI scan~Therapeutic Conventional Surgery: Undergo resection of tumor~Histopathologic Examination: Correlative studies"
11359426|NCT03036735|BG000|Baseline|Drug Eluding Spacer|nasal drug eluding spacer
11359427|NCT03036735|FG000|Participant Flow|Drug Eluding Spacer|Restora Mometasone Furate spacer
11359428|NCT03036735|OG000|Outcome|Drug Eluding Spacer|nasal drug eluding spacer
11359429|NCT03036735|EG000|Reported Event|Steroid Eluting Spacer|"Subjects will receive one steroid eluting spacer (Restora Mometasone Furate Eluting Spacer) placed into the surgical site on one side, and one spacer without drug (Silastic spacer) placed on the other side.~The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.~steroid eluting spacer: The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer."
11359430|NCT03029832|BG000|Baseline|MOXR0916 Plus Atezolizumab|Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
11359431|NCT03029832|BG001|Baseline|Atezolizumab|Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
11359432|NCT03029832|BG002|Baseline|Total|Total of all reporting groups
11359433|NCT03029832|FG000|Participant Flow|MOXR0916 Plus Atezolizumab|Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
11359434|NCT03029832|FG001|Participant Flow|Atezolizumab|Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
11359435|NCT03029832|OG000|Outcome|MOXR0916 Plus Atezolizumab|Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
11359436|NCT03029832|OG001|Outcome|Atezolizumab|Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
11359437|NCT03029832|EG000|Reported Event|MOXR0916 Plus Atezolizumab|Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
11359438|NCT03029832|EG001|Reported Event|Atezolizumab|Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
11359439|NCT03020446|BG000|Baseline|Sorbion Dressing to Venous Leg Ulcer|"any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed~Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks"
11359440|NCT03020446|FG000|Participant Flow|Sorbion Dressing to Venous Leg Ulcer|"any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed~Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks"
11359441|NCT03020446|OG000|Outcome|Sorbion Dressing to Venous Leg Ulcer|"any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed~Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks"
11359442|NCT03020446|EG000|Reported Event|Sorbion Dressing to Venous Leg Ulcer|"any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed~Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks"
11359443|NCT03031340|BG000|Baseline|Placebo|placebo: placebo
11359444|NCT03031340|BG001|Baseline|Pregabalin|Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
11359445|NCT03031340|BG002|Baseline|Total|Total of all reporting groups
11359446|NCT03031340|FG000|Participant Flow|Placebo|placebo: placebo
11359447|NCT03031340|FG001|Participant Flow|Pregabalin|Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
11359448|NCT03031340|OG000|Outcome|Placebo|placebo: placebo
11359449|NCT03031340|OG001|Outcome|Pregabalin|Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
11359450|NCT03031340|EG000|Reported Event|Placebo|placebo: placebo
11359451|NCT03031340|EG001|Reported Event|Pregabalin|Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
11359452|NCT03017040|BG000|Baseline|Participants With Unilateral Scapholunate Tear|"All subjects with a full scapholunate (SL) tear will have a CT scan and fluoroscopy images taken. The injured wrist will enroll in the SL tear group and the uninjured wrist as the control wrist.~CT scan: A CT scan of the wrist~Fluoroscopy Scan: A fluoroscopy scan of the wrist."
11359453|NCT03017040|FG000|Participant Flow|Scapholunate Tear|"Subjects with a full scapholunate (SL) tear will have a CT scan and fluoroscopy images taken. Subjects will enroll the injured wrist into the SL tear group and uninjured wrist into the control group. Thus each participant will flow into both study arms/groups and may appear to be counted twice, however, for this study we focus on number of wrists.~CT scan: A CT scan of the wrist~Fluoroscopy Scan: A fluoroscopy scan of the wrist."
11359454|NCT03017040|FG001|Participant Flow|Control Wrist|"Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control. Subjects will enroll the injured wrist into the SL tear group and uninjured wrist into the control group. Thus each participant will flow into both study arms/groups and may appear to be counted twice, however, for this study we focus on number of wrists.~CT scan: A CT scan of the wrist~Fluoroscopy Scan: A fluoroscopy scan of the wrist."
11359455|NCT03017040|OG000|Outcome|Scapholunate Tear|"Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken~CT scan: A CT scan of the wrist~Fluoroscopy Scan: A fluoroscopy scan of the wrist."
11359456|NCT03017040|OG001|Outcome|Control Wrist|"Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.~CT scan: A CT scan of the wrist~Fluoroscopy Scan: A fluoroscopy scan of the wrist."
11359457|NCT03017040|EG000|Reported Event|Scapholunate Tear|"Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken~CT scan: A CT scan of the wrist~Fluoroscopy Scan: A fluoroscopy scan of the wrist."
11359458|NCT03017040|EG001|Reported Event|Control Wrist|"Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.~CT scan: A CT scan of the wrist~Fluoroscopy Scan: A fluoroscopy scan of the wrist."
11359459|NCT03007719|BG000|Baseline|Cohort 1: Neoadjuvant|Patients with localized bladder cancer who are eligible for the University of California, San Francisco (UCSF) phase 2 clinical trial of neoadjuvant atezolizumab before definitive surgery (NCT02451423) (Cohort 1).
11359460|NCT03007719|BG001|Baseline|Cohort 2: Standard of Care (SOC)|Patients with any cancer type who are planned to initiate standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment (Cohort 2).
11359461|NCT03007719|BG002|Baseline|Total|Total of all reporting groups
11359462|NCT03007719|FG000|Participant Flow|Cohort 1: Neoadjuvant|Patients with localized bladder cancer who are eligible for the University of California, San Francisco (UCSF) phase 2 clinical trial of neoadjuvant atezolizumab before definitive surgery (NCT02451423) (Cohort 1).
11359463|NCT03007719|FG001|Participant Flow|Cohort 2: Standard of Care (SOC)|Patients with any cancer type who are planned to initiate standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment (Cohort 2).
11187049|NCT02104583|EG002|Reported Event|Cohort 2 Eleclazine 3 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
11187050|NCT02104583|EG003|Reported Event|Cohort 2 Eleclazine 6 mg|Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
11187051|NCT02104583|EG004|Reported Event|Cohort 2 Placebo|Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
11359464|NCT03007719|OG000|Outcome|Cohort 1: Neoadjuvant|Patients with localized bladder cancer who are eligible for the University of California, San Francisco (UCSF) phase 2 clinical trial of neoadjuvant atezolizumab before definitive surgery (NCT02451423) (Cohort 1).
11359465|NCT03007719|OG001|Outcome|Cohort 2: Standard of Care (SOC)|Patients with any cancer type who are planned to initiate standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment (Cohort 2).
11359466|NCT03007719|OG000|Outcome|Cohort 1: Neoadjuvant|"Patients with localized bladder cancer who are eligible for the UCSF phase 2 clinical trial of neoadjuvant atezolizumab before definitive surgery (NCT02451423) (Cohort 1). For the neoadjuvant cohort, study participants will undergo whole body PET/MR imaging with [18F]F-AraG within 7 days of initiating atezolizumab and within 7 days before surgery. Approximately 12 patients will be enrolled.~Fluorine F 18 Ara-G: Given IV~Positron Emission Tomography: Undergo PET/MR imaging~Magnetic Resonance Imaging: Undergo PET/MR imaging"
11359467|NCT03007719|EG000|Reported Event|Cohort 2: Standard of Care (SOC)|Patients with any cancer type who are planned to initiate standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment.
11359468|NCT03010423|BG000|Baseline|Nicorandil|Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
11359469|NCT03010423|FG000|Participant Flow|Nicorandil|Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
11359470|NCT03010423|OG000|Outcome|Nicorandil|Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
11359471|NCT03010423|EG000|Reported Event|Nicorandil|Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
11359472|NCT02985801|BG000|Baseline|Placebo First, Then Pancrelipase|"Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).~Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units~Placebo Oral Capsule: Placebo Oral Capsule"
11359473|NCT02985801|BG001|Baseline|Pancrelipase First, Then Placebo|"Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).~Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units~Placebo Oral Capsule: Placebo Oral Capsule"
11359474|NCT02985801|BG002|Baseline|Total|Total of all reporting groups
11359475|NCT02985801|FG000|Participant Flow|Placebo First, Then Pancrelipase|"Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).~Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units~Placebo Oral Capsule: Placebo Oral Capsule"
11359476|NCT02985801|FG001|Participant Flow|Pancrelipase First, Then Placebo|"Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).~Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units~Placebo Oral Capsule: Placebo Oral Capsule"
11359477|NCT02985801|OG000|Outcome|Placebo|Subjects who received placebo oral capsule in either the first or last 4 weeks of the study
11359478|NCT02985801|OG001|Outcome|Pancrelipase|Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study
11359479|NCT02985801|EG000|Reported Event|Placebo|Subjects who received placebo oral capsule in either the first or last 4 weeks of the study
11359480|NCT02985801|EG001|Reported Event|Pancrelipase|Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study
11359481|NCT02991430|BG000|Baseline|BID Placebo|Participants self-administered twice-daily inactive/sham treatments for 12 weeks followed by twice-daily active treatments for 12 weeks followed by a post-treatment observation period lasting 12 months.
11359482|NCT02991430|BG001|Baseline|BID Active|Participants self-administered twice-daily treatments for 12 weeks followed by twice-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months.
11359483|NCT02991430|BG002|Baseline|QD Active|Participants self-administered once-daily treatments for 12 weeks followed by once-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months.
11359484|NCT02991430|BG003|Baseline|Total|Total of all reporting groups
11359485|NCT02991430|FG000|Participant Flow|BID Placebo|Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359486|NCT02991430|FG001|Participant Flow|BID Active|Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359487|NCT02991430|FG002|Participant Flow|QD Active|Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359488|NCT02991430|OG000|Outcome|BID Placebo|Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359489|NCT02991430|OG001|Outcome|BID Active|Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359490|NCT02991430|OG002|Outcome|QD Active|Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359491|NCT02991430|EG000|Reported Event|BID Placebo|Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359492|NCT02991430|EG001|Reported Event|BID Active|Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359493|NCT02991430|EG002|Reported Event|QD Active|Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
11359494|NCT02995967|BG000|Baseline|Botulinum Toxin A Alone Group|"Intradetrusor injection of 100 units of botulinum toxin A alone~Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a"
11187052|NCT02104739|BG000|Baseline|All Participants|"This was a crossover study in which the 21 who were enrolled participated in each of three arms (the exenatide, saxagliptin, and placebo arms). There was an extension phase (that is, the exenatide extended-release (ER) arm) in which 8 of the 21 enrolled participated.~Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks"
11187053|NCT02104739|FG000|Participant Flow|Exenatide, Then Saxagliptin, Then Placebo|Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
11187054|NCT02104739|FG001|Participant Flow|Exenatide, Then Placebo, Then Saxagliptin|Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
11187055|NCT02104739|FG002|Participant Flow|Saxagliptin, Then Exenatide, Then Placebo|Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
11187056|NCT02104739|FG003|Participant Flow|Saxagliptin, Then Placebo, Then Exenatide|Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
11187057|NCT02104739|FG004|Participant Flow|Placebo, Then Exenatide, Then Saxagliptin|Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
11187058|NCT02104739|FG005|Participant Flow|Placebo, Then Saxagliptin, Then Exenatide|Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
11187059|NCT02104739|FG006|Participant Flow|Exenatide Extended-release (Extension Phase)|Exenatide arm: Single subcutaneous injection (10 mcg) Saxagliptin arm: Single dose orally (5 mg) Placebo arm: Placebo tablets and Placebo (normal saline) injections Exenatide extended-release (ER) arm: Subcutaneous injection (2mg) weekly for 6 weeks
11187060|NCT02104739|OG000|Outcome|Exenatide|Exenatide: Single subcutaneous injection (10 mcg)
11187061|NCT02104739|OG001|Outcome|Saxagliptin|Saxagliptin: Single dose orally (5 mg)
11187062|NCT02104739|OG002|Outcome|Placebo|Placebo: Placebo tablets and Placebo (normal saline) injections
11187063|NCT02104739|OG003|Outcome|Exenatide Extended-release (ER)|Exenatide extended-release (ER): Subcutaneous injection (2mg) weekly for 6 weeks
11187064|NCT02104739|EG000|Reported Event|Exenatide|Exenatide: Single subcutaneous injection (10 mcg)
11187065|NCT02104739|EG001|Reported Event|Saxagliptin|Saxagliptin: Single dose orally (5 mg)
11187066|NCT02104739|EG002|Reported Event|Placebo|Placebo: Placebo tablets and Placebo (normal saline) injections
11187067|NCT02104739|EG003|Reported Event|Exenatide Extended-release (ER)|Exenatide extended-release (ER): Subcutaneous injection (2mg) weekly for 6 weeks
11187068|NCT02104752|BG000|Baseline|Curcumin|"Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).~Curcumin: 360 mg/day (divided into twice daily oral doses)"
11187069|NCT02104752|BG001|Baseline|Sugar Pill|"Matched placebo, 2 capsules twice daily.~Placebo: Inactive, matched placebo (Sugar Pill)"
11187070|NCT02104752|BG002|Baseline|Total|Total of all reporting groups
11187071|NCT02104752|FG000|Participant Flow|Curcumin|"Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).~Curcumin: 360 mg/day (divided into twice daily oral doses)"
11187072|NCT02104752|FG001|Participant Flow|Sugar Pill|"Matched placebo, 2 capsules twice daily.~Placebo: Inactive, matched placebo (Sugar Pill)"
11187073|NCT02104752|OG000|Outcome|Curcumin|"Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).~Curcumin: 360 mg/day (divided into twice daily oral doses)"
11187074|NCT02104752|OG001|Outcome|Sugar Pill|"Matched placebo, 2 capsules twice daily.~Placebo: Inactive, matched placebo (Sugar Pill)"
11187075|NCT02104752|EG000|Reported Event|Curcumin|"Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).~Curcumin: 360 mg/day (divided into twice daily oral doses)"
11359495|NCT02995967|BG001|Baseline|Hydrodistention Group|"Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A~Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes."
11187076|NCT02104752|EG001|Reported Event|Sugar Pill|"Matched placebo, 2 capsules twice daily.~Placebo: Inactive, matched placebo (Sugar Pill)"
11187077|NCT02104765|BG000|Baseline|Placebo (SD)|1 subcutaneous (SC) dose of placebo
11187078|NCT02104765|BG001|Baseline|5 mg LY2951742 Single Dose (SD)|1 SC dose of 5 mg LY2951742
11187079|NCT02104765|BG002|Baseline|50 mg LY2951742 (SD)|1 SC dose of 50 mg LY2951742
11187080|NCT02104765|BG003|Baseline|120 mg LY2951742 (SD)|1 SC dose of 120 mg LY2951742
11187081|NCT02104765|BG004|Baseline|300 mg LY2951742 (SD)|1 SC dose of 300 mg LY2951742.
11187082|NCT02104765|BG005|Baseline|Placebo Q4W|3 SC doses of placebo every 4 Weeks (Q4W)
11187083|NCT02104765|BG006|Baseline|300 mg LY2951742 Q4W|3 SC doses of 300 mg LY2951742 Q4W
11187084|NCT02104765|BG007|Baseline|Total|Total of all reporting groups
11187085|NCT02104765|FG000|Participant Flow|Placebo (SD)|1 subcutaneous (SC) dose of placebo
11187086|NCT02104765|FG001|Participant Flow|5 mg LY2951742 Single Dose (SD)|1 SC dose of 5 mg LY2951742
11187087|NCT02104765|FG002|Participant Flow|50 mg LY2951742 (SD)|1 SC dose of 50 mg LY2951742
11359496|NCT02995967|BG002|Baseline|Total|Total of all reporting groups
11359497|NCT02995967|FG000|Participant Flow|Botulinum Toxin A Alone Group|"Intradetrusor injection of 100 units of botulinum toxin A alone~Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a"
11359498|NCT02995967|FG001|Participant Flow|Hydrodistention Group|"Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A~Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes."
11359499|NCT02995967|OG000|Outcome|Botulinum Toxin A Alone Group|"Intradetrusor injection of 100 units of botulinum toxin A alone~Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a"
11359500|NCT02995967|OG001|Outcome|Hydrodistention Group|"Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A~Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes."
11359501|NCT02995967|OG000|Outcome|Botulinum Toxin A Alone Group|"Just the intradetrusor injection of 100 units of botulinum toxin A alone~Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a"
11359502|NCT02995967|EG000|Reported Event|Botulinum Toxin A Alone Group|"Intradetrusor injection of 100 units of botulinum toxin A alone~Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a"
11359503|NCT02995967|EG001|Reported Event|Hydrodistention Group|"Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A~Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes."
11359504|NCT02994251|BG000|Baseline|All Subjects|"Patients must have advanced, unresectable intrahepatic cholangiocarcinoma (ICC) defined as biopsy-confirmed adenocarcinoma in the liver, with an immunohistochemical profile consistent with a pancreatico-biliary primary, not involving the common bile duct or bifurcation, and not amenable to surgical resection.~gemcitabine: 1000 mg/m^2 of gemcitabine on Day 1 and 8, Dosages may be modified or delayed due to toxicities~Cisplatin: 25 mg/m^2 on Day 1 and 8, Dosages may be modified or delayed due to toxicities~Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C: If conventional transarterial chemoembolization (TACE) is warranted based on MRI assessment and the patient meets all the eligibility criteria for TACE therapy, then cTACE will be scheduled to take place during Week 3 of that cycle. Patients will always receive the first cTACE for study; follow-up cTACE will occur on demand."
11359505|NCT02994251|FG000|Participant Flow|All Subjects|"Patients must have advanced, unresectable intrahepatic cholangiocarcinoma (ICC) defined as biopsy-confirmed adenocarcinoma in the liver, with an immunohistochemical profile consistent with a pancreatico-biliary primary, not involving the common bile duct or bifurcation, and not amenable to surgical resection.~gemcitabine: 1000 mg/m^2 of gemcitabine on Day 1 and 8, Dosages may be modified or delayed due to toxicities~Cisplatin: 25 mg/m^2 on Day 1 and 8, Dosages may be modified or delayed due to toxicities~Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C: If conventional transarterial chemoembolization (TACE) is warranted based on MRI assessment and the patient meets all the eligibility criteria for TACE therapy, then cTACE will be scheduled to take place during Week 3 of that cycle. Patients will always receive the first cTACE for study; follow-up cTACE will occur on demand."
11359506|NCT02994251|OG000|Outcome|All Subjects|"Patients must have advanced, unresectable intrahepatic cholangiocarcinoma (ICC) defined as biopsy-confirmed adenocarcinoma in the liver, with an immunohistochemical profile consistent with a pancreatico-biliary primary, not involving the common bile duct or bifurcation, and not amenable to surgical resection.~gemcitabine: 1000 mg/m^2 of gemcitabine on Day 1 and 8, Dosages may be modified or delayed due to toxicities~Cisplatin: 25 mg/m^2 on Day 1 and 8, Dosages may be modified or delayed due to toxicities~Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C: If conventional transarterial chemoembolization (TACE) is warranted based on MRI assessment and the patient meets all the eligibility criteria for TACE therapy, then cTACE will be scheduled to take place during Week 3 of that cycle. Patients will always receive the first cTACE for study; follow-up cTACE will occur on demand."
11359507|NCT02994251|EG000|Reported Event|All Subjects|"Patients must have advanced, unresectable intrahepatic cholangiocarcinoma (ICC) defined as biopsy-confirmed adenocarcinoma in the liver, with an immunohistochemical profile consistent with a pancreatico-biliary primary, not involving the common bile duct or bifurcation, and not amenable to surgical resection.~gemcitabine: 1000 mg/m^2 of gemcitabine on Day 1 and 8, Dosages may be modified or delayed due to toxicities~Cisplatin: 25 mg/m^2 on Day 1 and 8, Dosages may be modified or delayed due to toxicities~Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C: If conventional transarterial chemoembolization (TACE) is warranted based on MRI assessment and the patient meets all the eligibility criteria for TACE therapy, then cTACE will be scheduled to take place during Week 3 of that cycle. Patients will always receive the first cTACE for study; follow-up cTACE will occur on demand."
11376212|NCT01286272|EG001|Reported Event|Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)|"INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.~MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses."
11376213|NCT01275313|BG000|Baseline|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
11187088|NCT02104765|FG003|Participant Flow|120 mg LY2951742 (SD)|1 SC dose of 120 mg LY2951742
11359508|NCT02978885|BG000|Baseline|Normal Preoperative Lung Function|"Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).~SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT~AxV-128/Tc: Injection of AxV-128 labeled with 99mTc~Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.~Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care."
11359509|NCT02978885|BG001|Baseline|Preoperative COPD|"Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).~SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT~AxV-128/Tc: Injection of AxV-128 labeled with 99mTc~Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.~Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care."
11359510|NCT02978885|BG002|Baseline|Total|Total of all reporting groups
11359511|NCT02978885|FG000|Participant Flow|Normal Preoperative Lung Function|"Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).~SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT~AxV-128/Tc: Injection of AxV-128 labeled with 99mTc~Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.~Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care."
11359512|NCT02978885|FG001|Participant Flow|Preoperative COPD|"Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).~SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT~AxV-128/Tc: Injection of AxV-128 labeled with 99mTc~Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.~Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care."
11359513|NCT02978885|OG000|Outcome|Normal Preoperative Lung Function|"Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).~SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT~AxV-128/Tc: Injection of AxV-128 labeled with 99mTc~Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.~Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care."
11376214|NCT01275313|BG001|Baseline|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
11187089|NCT02104765|FG004|Participant Flow|300 mg LY2951742 (SD)|1 SC dose of 300 mg LY2951742.
11376215|NCT01275313|BG002|Baseline|Total|Total of all reporting groups
11376216|NCT01275313|FG000|Participant Flow|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
11376217|NCT01275313|FG001|Participant Flow|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
11376218|NCT01275313|OG000|Outcome|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
11187090|NCT02104765|FG005|Participant Flow|Placebo Q4W|3 SC doses of placebo every 4 Weeks (Q4W)
11187091|NCT02104765|FG006|Participant Flow|300 mg LY2951742 Q4W|3 SC doses of 300 mg LY2951742 Q4W
11187092|NCT02104765|OG000|Outcome|Placebo (SD)|1 subcutaneous (SC) dose of placebo
11187093|NCT02104765|OG001|Outcome|5 mg LY2951742 Single Dose (SD)|1 SC dose of 5 mg LY2951742
11187094|NCT02104765|OG002|Outcome|50 mg LY2951742 (SD)|1 SC dose of 50 mg LY2951742
11187095|NCT02104765|OG003|Outcome|120 mg LY2951742 (SD)|1 SC dose of 120 mg LY2951742
11187096|NCT02104765|OG004|Outcome|300 mg LY2951742 (SD)|1 SC dose of 300 mg LY2951742.
11187097|NCT02104765|OG005|Outcome|Placebo Q4W|3 SC doses of placebo Q4W
11187098|NCT02104765|OG006|Outcome|300 mg LY2951742 Q4W|3 SC doses of 300 mg LY2951742 Q4W
11187099|NCT02104765|OG000|Outcome|5 mg LY2951742 (SD)|1 SC dose of 5 mg LY2951742
11187100|NCT02104765|OG001|Outcome|50 mg LY2951742 (SD)|1 SC dose of 50 mg LY2951742
11187101|NCT02104765|OG002|Outcome|120 mg LY2951742 (SD)|1 SC dose of 120 mg LY2951742
11187102|NCT02104765|OG003|Outcome|300 mg LY2951742 (SD)|1 SC dose of 300 mg LY2951742.
11187103|NCT02104765|OG004|Outcome|300 mg LY2951742 Q4W|3 SC doses of 300 mg LY2951742 Q4W
11187104|NCT02104765|OG004|Outcome|300 mg LY2951742 Q4W, Day 57|3 SC doses of 300 mg LY2951742 Q4W
11187105|NCT02104765|EG000|Reported Event|Placebo (SD)|1 subcutaneous (SC) dose of placebo
11187106|NCT02104765|EG001|Reported Event|5 mg LY2951742 Single Dose (SD)|1 SC dose 5 mg of LY2951742
11187107|NCT02104765|EG002|Reported Event|50 mg LY2951742 (SD)|1 SC dose 50 mg LY2951742
11187108|NCT02104765|EG003|Reported Event|120 mg LY2951742 (SD)|1 SC dose 120 mg of LY2951742
11187109|NCT02104765|EG004|Reported Event|300 mg LY2951742 (SD)|2 SC doses 300 mg of LY2951742
11187110|NCT02104765|EG005|Reported Event|Placebo Q4W|3 SC doses of placebo Q4W
11187111|NCT02104765|EG006|Reported Event|300 mg LY2951742 Q4W|3 SC doses of 300 mg LY2951742 Q4W
11187112|NCT02104804|BG000|Baseline|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
11187113|NCT02104804|BG001|Baseline|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
11187114|NCT02104804|BG002|Baseline|Total|Total of all reporting groups
11376219|NCT01275313|OG001|Outcome|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
11187115|NCT02104804|FG000|Participant Flow|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
11187116|NCT02104804|FG001|Participant Flow|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
11187117|NCT02104804|OG000|Outcome|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
11187118|NCT02104804|OG001|Outcome|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
11187119|NCT02104804|EG000|Reported Event|PLACEBO QD + INSULIN WITH OR WITHOUT METFORMIN|
11187120|NCT02104804|EG001|Reported Event|SAXAGLIPTIN 5 MG QD + INSULIN WITH OR WITHOUT METFORMIN|
11187121|NCT02104817|BG000|Baseline|Epanova|Omega-3 carboxylic acid 4 x 1 gram capsule
11187122|NCT02104817|BG001|Baseline|Placebo|Corn oil 4 x 1 gram capsule
11187123|NCT02104817|BG002|Baseline|Total|Total of all reporting groups
11187124|NCT02104817|FG000|Participant Flow|Epanova|Omega-3 carboxylic acid 4 x 1 gram capsule
11187125|NCT02104817|FG001|Participant Flow|Placebo|Corn oil 4 x 1 gram capsule
11187126|NCT02104817|OG000|Outcome|Epanova|Omega-3 carboxylic acid 4 x 1 gram capsule
11187127|NCT02104817|OG001|Outcome|Placebo|Corn oil 4 x 1 gram capsule
11187128|NCT02104817|EG000|Reported Event|Epanova|Omega-3 carboxylic acid 4 x 1 gram capsule
11187129|NCT02104817|EG001|Reported Event|Placebo|Corn oil 4 x 1 gram capsule
11187130|NCT02104830|BG000|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days~empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
11187131|NCT02104830|BG001|Baseline|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.~empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml.~Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg."
11187132|NCT02104830|BG002|Baseline|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
11187133|NCT02104830|BG003|Baseline|Total|Total of all reporting groups
11187134|NCT02104830|FG000|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
11187135|NCT02104830|FG001|Participant Flow|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
11187136|NCT02104830|FG002|Participant Flow|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
11359514|NCT02978885|OG001|Outcome|Preoperative COPD|"Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).~SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT~AxV-128/Tc: Injection of AxV-128 labeled with 99mTc~Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.~Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care."
11359515|NCT02978885|EG000|Reported Event|Normal Preoperative Lung Function|"Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).~SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT~AxV-128/Tc: Injection of AxV-128 labeled with 99mTc~Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.~Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care."
11359516|NCT02978885|EG001|Reported Event|Preoperative COPD|"Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).~SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT~AxV-128/Tc: Injection of AxV-128 labeled with 99mTc~Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.~Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care."
11359517|NCT02978833|BG000|Baseline|Platelet-rich Plasma|"PRP~Ultrasound"
11359518|NCT02978833|BG001|Baseline|Whole Blood|Whole Blood
11359519|NCT02978833|BG002|Baseline|Total|Total of all reporting groups
11359520|NCT02978833|FG000|Participant Flow|Platelet-rich Plasma|"PRP~Ultrasound"
11359521|NCT02978833|FG001|Participant Flow|Whole Blood|Whole Blood
11359522|NCT02978833|OG000|Outcome|Platelet-rich Plasma|"PRP~Ultrasound"
11359523|NCT02978833|OG001|Outcome|Whole Blood|Whole Blood
11359524|NCT02978833|OG000|Outcome|Platelet-rich Plasma|PRP
11359525|NCT02978833|EG000|Reported Event|Platelet-rich Plasma|"PRP~Ultrasound"
11359526|NCT02978833|EG001|Reported Event|Whole Blood|Whole Blood
11359527|NCT02971839|BG000|Baseline|VX-561 20 mg|Participants received VX-561 20 mg orally once daily for 28 days.
11359528|NCT02971839|BG001|Baseline|VX-561 100 mg|Participants received VX-561 100 mg orally once daily for 28 days.
11359529|NCT02971839|BG002|Baseline|VX-561 150 mg|Participants received VX-561 150 mg orally once daily for 28 days.
11359530|NCT02971839|BG003|Baseline|Placebo|Participants received placebo matched to VX-561 orally once daily for 28 days.
11359531|NCT02971839|BG004|Baseline|Ivacaftor|Participants received Ivacaftor 150 mg orally every 12 hours for 28 days.
11359532|NCT02971839|BG005|Baseline|Total|Total of all reporting groups
11359533|NCT02971839|FG000|Participant Flow|VX-561 20 mg|Participants received VX-561 20 mg orally once daily for 28 days.
11359534|NCT02971839|FG001|Participant Flow|VX-561 100 mg|Participants received VX-561 100 mg orally once daily for 28 days.
11359535|NCT02971839|FG002|Participant Flow|VX-561 150 mg|Participants received VX-561 150 mg orally once daily for 28 days.
11359536|NCT02971839|FG003|Participant Flow|Placebo|Participants received placebo matched to VX-561 orally once daily for 28 days.
11359537|NCT02971839|FG004|Participant Flow|Ivacaftor|Participants received Ivacaftor 150 mg orally every 12 hours for 28 days.
11359538|NCT02971839|OG000|Outcome|VX-561 20 mg|Participants received VX-561 20 mg orally once daily for 28 days.
11359539|NCT02971839|OG001|Outcome|VX-561 100 mg|Participants received VX-561 100 mg orally once daily for 28 days.
11359540|NCT02971839|OG002|Outcome|VX-561 150 mg|Participants received VX-561 150 mg orally once daily for 28 days.
11359541|NCT02971839|OG003|Outcome|Placebo|Participants received placebo matched to VX-561 orally once daily for 28 days.
11359542|NCT02971839|OG004|Outcome|Ivacaftor|Participants received Ivacaftor 150 mg orally every 12 hours for 28 days.
11359543|NCT02971839|EG000|Reported Event|VX-561 20 mg|Participants received VX-561 20 mg orally once daily for 28 days.
11359544|NCT02971839|EG001|Reported Event|VX-561 100 mg|Participants received VX-561 100 mg orally once daily for 28 days.
11359545|NCT02971839|EG002|Reported Event|VX-561 150 mg|Participants received VX-561 150 mg orally once daily for 28 days.
11359546|NCT02971839|EG003|Reported Event|Placebo|Participants received placebo matched to VX-561 orally once daily for 28 days.
11359547|NCT02971839|EG004|Reported Event|Ivacaftor|Participants received Ivacaftor 150 mg orally every 12 hours for 28 days.
11359548|NCT02985840|BG000|Baseline|Ondansetron|"Ondansetron (4 mg) followed by two 5 ml normal saline flush~Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes"
11359549|NCT02985840|BG001|Baseline|Ondansetron Plus Dexamethasone|"Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush~Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes~Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush"
11359550|NCT02985840|BG002|Baseline|Total|Total of all reporting groups
11359551|NCT02985840|FG000|Participant Flow|Ondansetron|"Ondansetron (4 mg) followed by two 5 ml normal saline flush~Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes"
11359552|NCT02985840|FG001|Participant Flow|Ondansetron Plus Dexamethasone|"Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush~Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes~Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush"
11359553|NCT02985840|OG000|Outcome|Ondansetron|"Ondansetron (4 mg) followed by two 5 ml normal saline flush~Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes"
11359554|NCT02985840|OG001|Outcome|Ondansetron Plus Dexamethasone|"Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush~Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes~Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush"
11359555|NCT02985840|EG000|Reported Event|Ondansetron|"Ondansetron (4 mg) followed by two 5 ml normal saline flush~Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes"
11359556|NCT02985840|EG001|Reported Event|Ondansetron Plus Dexamethasone|"Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush~Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes~Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush"
11359557|NCT02966223|BG000|Baseline|MRI and HIDA Scan|MRI and HIDA scan: Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan
11359558|NCT02966223|FG000|Participant Flow|MRI and HIDA Scan|MRI and HIDA scan: Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan
11359559|NCT02966223|OG000|Outcome|MRI and HIDA Scan|MRI and HIDA scan: Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan
11359560|NCT02966223|EG000|Reported Event|MRI and HIDA Scan|MRI and HIDA scan: Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan
11359561|NCT02965846|BG000|Baseline|AGN-195263|One drop of 0.1% AGN-195263 instilled in each eye twice daily
11359562|NCT02965846|BG001|Baseline|Vehicle|One drop of Vehicle (placebo) instilled in each eye twice daily
11359563|NCT02965846|BG002|Baseline|Enrolled But Not Randomized|Run-In period before randomization
11359564|NCT02965846|BG003|Baseline|Total|Total of all reporting groups
11359565|NCT02965846|FG000|Participant Flow|AGN-195263|One drop of 0.1% AGN-195263 instilled in each eye twice daily
11359566|NCT02965846|FG001|Participant Flow|Vehicle|One drop of Vehicle (placebo) instilled in each eye twice daily
11359567|NCT02965846|FG002|Participant Flow|Enrolled But Not Randomized|Run-In period before randomization
11359568|NCT02965846|OG000|Outcome|AGN-195263|One drop of 0.1% AGN-195263 instilled in each eye twice daily
11359569|NCT02965846|OG001|Outcome|Vehicle|One drop of Vehicle (placebo) instilled in each eye twice daily
11359570|NCT02965846|EG000|Reported Event|AGN-195263|One drop of 0.1% AGN-195263 instilled in each eye twice daily
11359571|NCT02965846|EG001|Reported Event|Vehicle|One drop of Vehicle (placebo) instilled in each eye twice daily
11359572|NCT02974803|BG000|Baseline|Dabrafenib and Trametinib|"Dabrafenib, PO, 150mg BID Continuously Trameteinib, PO 2mg OD Continuously~Dabrafenib~Trametinib"
11359573|NCT02974803|FG000|Participant Flow|Dabrafenib and Trametinib|"Dabrafenib, PO, 150mg BID Continuously Trameteinib, PO 2mg OD Continuously~Dabrafenib~Trametinib"
11359574|NCT02974803|OG000|Outcome|Dabrafenib and Trametinib|"Dabrafenib, PO, 150mg BID Continuously Trameteinib, PO 2mg OD Continuously~Dabrafenib~Trametinib"
11359575|NCT02974803|EG000|Reported Event|Dabrafenib and Trametinib|"Dabrafenib, PO, 150mg BID Continuously Trameteinib, PO 2mg OD Continuously~Dabrafenib~Trametinib"
11359576|NCT02974686|BG000|Baseline|Interventional (EVR)|"Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus~Everolimus"
11359577|NCT02974686|BG001|Baseline|Prior Agent (MPA)|"Patient will have baseline data collected while on MPA for comparison with EVR~Mycophenolic Acid"
11359578|NCT02974686|BG002|Baseline|Total|Total of all reporting groups
11359579|NCT02974686|FG000|Participant Flow|Interventional Everolimus (EVR)|"Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus~Everolimus"
11359580|NCT02974686|FG001|Participant Flow|Prior Agent Mycophenolic Acid (MPA)|"Patient will have baseline data collected while on MPA for comparison with EVR~Mycophenolic Acid"
11359581|NCT02974686|OG000|Outcome|Interventional (EVR)|"Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus~Everolimus"
11359582|NCT02974686|OG001|Outcome|Prior Agent (MPA)|"Patient will have baseline data collected while on MPA for comparison with EVR~Mycophenolic Acid"
11359583|NCT02974686|OG000|Outcome|Interventional Everolimus (EVR)|"Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus~Everolimus"
11359584|NCT02974686|OG001|Outcome|Prior Agent Mycophenolic Acid (MPA)|"Patient will have baseline data collected while on MPA for comparison with EVR~Mycophenolic Acid"
11359585|NCT02974686|EG000|Reported Event|Interventional (EVR)|"Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus~Everolimus"
11359586|NCT02974686|EG001|Reported Event|Prior Agent (MPA)|"Patient will have baseline data collected while on MPA for comparison with EVR~Mycophenolic Acid"
11359587|NCT02956005|BG000|Baseline|Envarsus|"Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL~ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant"
11359588|NCT02956005|FG000|Participant Flow|Envarsus|"Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL~ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant"
11359589|NCT02956005|OG000|Outcome|Envarsus|"Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL~ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant"
11359590|NCT02956005|EG000|Reported Event|Envarsus|"Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL~ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant"
11359591|NCT02966184|BG000|Baseline|Benzalkonium Chloride-Containing Albuterol|This arm includes the current standard of care (preservative-containing albuterol nebulization) which patients receive at the institution. No interventions will be made within this group of patients.
11359592|NCT02966184|BG001|Baseline|Preservative-Free Albuterol|This arm includes the preservative-free albuterol nebulization which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.
10962036|NCT00864383|BG000|Baseline|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
11359593|NCT02966184|BG002|Baseline|Total|Total of all reporting groups
11359594|NCT02966184|FG000|Participant Flow|Benzalkonium Chloride-Containing Albuterol|This arm includes the current standard of care (preservative-containing albuterol nebulization) which patients receive at the institution. No interventions will be made within this group of patients.
11359595|NCT02966184|FG001|Participant Flow|Preservative-Free Albuterol|This arm includes the preservative-free albuterol nebulization which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.
11359596|NCT02966184|OG000|Outcome|Benzalkonium Chloride-Containing Albuterol|This arm includes the current standard of care (preservative-containing albuterol nebulization) which patients receive at the institution. No interventions will be made within this group of patients.
11359597|NCT02966184|OG001|Outcome|Preservative-Free Albuterol|This arm includes the preservative-free albuterol nebulization which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.
11359598|NCT02966184|EG000|Reported Event|Benzalkonium Chloride-Containing Albuterol|This arm includes the current standard of care (preservative-containing albuterol nebulization) which patients receive at the institution. No interventions will be made within this group of patients.
11359599|NCT02966184|EG001|Reported Event|Preservative-Free Albuterol|This arm includes the preservative-free albuterol nebulization which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.
11359600|NCT02940223|BG000|Baseline|Intervention Group (Icosapent Ethyl)|Received 1 mg Icosapent Ethyl capsules orally twice a daily plus physical activity for 8 weeks
11359601|NCT02940223|BG001|Baseline|Placebo|Received placebo capsules orally twice a day plus physical activity for 8 weeks
11359602|NCT02940223|BG002|Baseline|Total|Total of all reporting groups
11359603|NCT02940223|FG000|Participant Flow|Intervention Group (Icosapent Ethyl)|Received 1 mg Icosapent Ethyl capsules orally twice a daily plus physical activity for 8 weeks
11359604|NCT02940223|FG001|Participant Flow|Placebo|Received placebo capsules orally twice a day plus physical activity for 8 weeks
11359605|NCT02940223|OG000|Outcome|Intervention Group (Icosapent Ethyl)|Received 1 mg Icosapent Ethyl capsules orally twice a daily plus physical activity for 8 weeks
11359606|NCT02940223|OG001|Outcome|Placebo|Received placebo capsules orally twice a day plus physical activity for 8 weeks
11359607|NCT02940223|EG000|Reported Event|Intervention Group (Icosapent Ethyl)|Received 1 mg Icosapent Ethyl capsules orally twice a daily plus physical activity for 8 weeks
11359608|NCT02940223|EG001|Reported Event|Placebo|Received placebo capsules orally twice a day plus physical activity for 8 weeks
11359609|NCT02954159|BG000|Baseline|Treatment Arm|"vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)~Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.~Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care."
11359610|NCT02954159|BG001|Baseline|Placebo Arm|"vedolizumab at standard regimen with placebo.~Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.~Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm."
11359611|NCT02954159|BG002|Baseline|Total|Total of all reporting groups
11359612|NCT02954159|FG000|Participant Flow|Treatment Arm|"vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)~Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.~Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care."
11359613|NCT02954159|FG001|Participant Flow|Placebo Arm|"vedolizumab at standard regimen with placebo.~Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.~Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm."
11359614|NCT02954159|OG000|Outcome|Treatment Arm|"vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)~Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.~Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care."
11359615|NCT02954159|OG001|Outcome|Placebo Arm|"vedolizumab at standard regimen with placebo.~Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.~Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm."
11359616|NCT02954159|EG000|Reported Event|Treatment Arm|"vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)~Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.~Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care."
11187137|NCT02104830|OG000|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
11187138|NCT02104830|OG001|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
11187139|NCT02104830|OG002|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
11359617|NCT02954159|EG001|Reported Event|Placebo Arm|"vedolizumab at standard regimen with placebo.~Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.~Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm."
11359618|NCT02954952|BG000|Baseline|Standard of Care (Baseline)|"Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.~PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement."
11359619|NCT02954952|BG001|Baseline|PSI Rev 1.X|"The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).~PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement."
11359620|NCT02954952|BG002|Baseline|PSI Rev 2.X|"The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).~PSI Rev 2.X: PSI Rev 2.X is a newer version of the PSI measurement."
11359621|NCT02954952|BG003|Baseline|Total|Total of all reporting groups
11187140|NCT02104830|EG000|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
11359622|NCT02954952|FG000|Participant Flow|Standard of Care (Baseline)|"Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.~PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement."
11359623|NCT02954952|FG001|Participant Flow|PSI Rev 1.X|"The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).~PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement."
11359624|NCT02954952|FG002|Participant Flow|PSI Rev 2.X|"The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).~PSI Rev 2.X: PSI Rev 2.X is a newer version of the PSI measurement."
11359625|NCT02954952|OG000|Outcome|Standard of Care (Baseline)|"Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.~PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement."
11187141|NCT02104830|EG001|Reported Event|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
11187142|NCT02104830|EG002|Reported Event|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
11359626|NCT02954952|OG001|Outcome|PSI Rev 1.X|"The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).~PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement."
11359627|NCT02954952|OG002|Outcome|PSI Rev 2.X|"The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).~PSI Rev 2.X: PSI Rev 2.X is a newer version of the PSI measurement."
11359628|NCT02954952|EG000|Reported Event|Standard of Care (Baseline)|"Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.~PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement."
11359629|NCT02954952|EG001|Reported Event|PSI Rev 1.X|"The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).~PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement."
11359630|NCT02954952|EG002|Reported Event|PSI Rev 2.X|"The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).~PSI Rev 2.X: PSI Rev 2.X is a newer version of the PSI measurement."
11359631|NCT02950896|BG000|Baseline|Intraoperative FHR Monitoring|"Intraoperative fetal heart rate (FHR) monitoring~observational fetal heart rate monitoring: Patients will have fetal heart rate monitoring"
11359632|NCT02950896|FG000|Participant Flow|Intraoperative FHR Monitoring|"Intraoperative fetal heart rate (FHR) monitoring~observational fetal heart rate monitoring: Patients will have fetal heart rate monitoring"
11359633|NCT02950896|OG000|Outcome|Intraoperative FHR Monitoring|"Intraoperative fetal heart rate (FHR) monitoring~observational fetal heart rate monitoring: Patients will have fetal heart rate monitoring"
11359634|NCT02950896|EG000|Reported Event|Intraoperative FHR Monitoring|"Intraoperative fetal heart rate (FHR) monitoring~observational fetal heart rate monitoring: Patients will have fetal heart rate monitoring"
11359635|NCT02947022|BG000|Baseline|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
11359636|NCT02947022|FG000|Participant Flow|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
11359637|NCT02947022|OG000|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
11359638|NCT02947022|OG000|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
11359639|NCT02947022|OG000|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
11359640|NCT02947022|OG000|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1"
11376220|NCT01275313|EG000|Reported Event|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
11359641|NCT02947022|EG000|Reported Event|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
11359642|NCT02936999|BG000|Baseline|Treatment Group|Patients will receive 100,000IU PO loading dose at Day 1. The loading dose must be administered to the patient at the investigator's site.
11359643|NCT02936999|FG000|Participant Flow|Treatment Group|Patients will receive 100,000 IU PO loading dose at Day 1. The loading dose must be administered to the patient at the investigator's site.
11359644|NCT02936999|OG000|Outcome|Treatment Group|Patients will receive 100,000IU PO loading dose at Day 1. The loading dose must be administered to the patient at the investigator's site.
11359645|NCT02936999|OG000|Outcome|Vitamin D3|"Patients will be dispensed cholecalciferol, 32 capsules/bottle of 1cap/4000 IU PO QD on Day 1 visit to take home. Bottle must be labeled with instructions on how to take the drug and the assigned patient ID number. Patients will be instructed to take 1 capsule per day, with water, for 29 days using the dispensed study bottle. They will be instructed to stop taking their daily vitamin D3 dose after 30 days of treatment. A study drug diary will be provided at Day 1 visit and patients will be instructed to complete the study drug diary daily from Day 2 to Day 30. Patient's report of vitamin-D3 intake from the diary must be reconciled against the number of capsules returned at Day 30 visit.~Cholecalciferol: Cholecalciferol 100,000 IU followed by 4000 IU orally once daily for 30 days."
11359646|NCT02936999|OG000|Outcome|Treatment Group|Patients will receive 100,000 IU PO loading dose at Day 1. The loading dose must be administered to the patient at the investigator's site.
11359647|NCT02936999|EG000|Reported Event|Treatment Group|Patients will receive 100,000 IU PO loading dose at Day 1. The loading dose must be administered to the patient at the investigator's site.
11359648|NCT02950480|BG000|Baseline|Zafirlukast|"Zafirlukast~zafirlukast: Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to five half-lives of the drug. Patients will be seen every 1 to 2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture every two weeks."
11359649|NCT02950480|BG001|Baseline|Standard of Care (no Intervention)|"Standard of Care (no intervention)~Standard of Care (no intervention): Standard of Care (no intervention)"
11359650|NCT02950480|BG002|Baseline|Total|Total of all reporting groups
11359651|NCT02950480|FG000|Participant Flow|Zafirlukast|"Zafirlukast~zafirlukast: Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to five half-lives of the drug. Patients will be seen every 1 to 2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture every two weeks."
11359652|NCT02950480|FG001|Participant Flow|Standard of Care (no Intervention)|"Standard of Care (no intervention)~Standard of Care (no intervention): Standard of Care (no intervention)"
11359653|NCT02950480|OG000|Outcome|Zafirlukast|"Zafirlukast~zafirlukast: Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to five half-lives of the drug. Patients will be seen every 1 to 2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture every two weeks."
11359654|NCT02950480|OG001|Outcome|Standard of Care (no Intervention)|"Standard of Care (no intervention)~Standard of Care (no intervention): Standard of Care (no intervention)"
11187143|NCT02104895|BG000|Baseline|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
11359655|NCT02950480|EG000|Reported Event|Zafirlukast|"Zafirlukast~zafirlukast: Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to five half-lives of the drug. Patients will be seen every 1 to 2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture every two weeks."
11359656|NCT02950480|EG001|Reported Event|Standard of Care (no Intervention)|"Standard of Care (no intervention)~Standard of Care (no intervention): Standard of Care (no intervention)"
11359657|NCT02949947|BG000|Baseline|Group A - Ferric Carboxymaltose|"Participants receive a Ferric Carboxymaltose injection by vein. Dose repeated 1 week later.~Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.~Ferric Carboxymaltose: 15 mg/kg by vein (up to 750 mg) over 15 min infusion. Dose repeated 1 week later.~Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24."
11376221|NCT01275313|EG001|Reported Event|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
11359658|NCT02949947|BG001|Baseline|Group B - Iron Supplement|"Participants take iron supplements by mouth every day for up to 3 months.~Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.~Iron Supplements: Participants take iron supplements by mouth every day for up to 3 months.~Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24."
11359659|NCT02949947|BG002|Baseline|Total|Total of all reporting groups
11238512|NCT02463487|BG001|Baseline|Cardinal Pro + Irrigation (NPWTi)|"Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation~Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®"
11238513|NCT02463487|BG002|Baseline|Total|Total of all reporting groups
11238514|NCT02463487|FG000|Participant Flow|Cardinal Pro + Irrigation (NPWTi)|"Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation~Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®"
11238515|NCT02463487|FG001|Participant Flow|Cardinal Pro (NPWT) Therapy|"Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation~Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface"
11238516|NCT02463487|OG000|Outcome|Cardinal Pro (NPWT) Therapy|"Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation~Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface"
11238517|NCT02463487|OG001|Outcome|Cardinal Pro + Irrigation (NPWTi)|"Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation~Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®"
11238518|NCT02463487|EG000|Reported Event|Cardinal Pro (NPWT) Therapy|"Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation~Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface"
11238519|NCT02463487|EG001|Reported Event|Cardinal Pro + Irrigation (NPWTi)|"Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation~Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®"
11238520|NCT02463799|BG000|Baseline|Sipuleucel-T and Radium 223 Combination|"Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20~Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223~Sipuleucel-T: 3 infusions of sipuleucel-T alone"
11238521|NCT02463799|BG001|Baseline|Sipuleucel-T Alone|"Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Sipuleucel-T: 3 infusions of sipuleucel-T alone"
11238522|NCT02463799|BG002|Baseline|Total|Total of all reporting groups
11238523|NCT02463799|FG000|Participant Flow|Sipuleucel-T and Radium 223 Combination|"Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20~Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223~Sipuleucel-T: 3 infusions of sipuleucel-T alone"
11238524|NCT02463799|FG001|Participant Flow|Sipuleucel-T Alone|"Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Sipuleucel-T: 3 infusions of sipuleucel-T alone"
11238525|NCT02463799|OG000|Outcome|Sipuleucel-T and Radium 223 Combination|"Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20~Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223~Sipuleucel-T: 3 infusions of sipuleucel-T alone"
11238526|NCT02463799|OG001|Outcome|Sipuleucel-T Alone|"Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Sipuleucel-T: 3 infusions of sipuleucel-T alone"
11238527|NCT02463799|EG000|Reported Event|Sipuleucel-T and Radium 223 Combination|"Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20~Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223~Sipuleucel-T: 3 infusions of sipuleucel-T alone"
11238528|NCT02463799|EG001|Reported Event|Sipuleucel-T Alone|"Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Sipuleucel-T: 3 infusions of sipuleucel-T alone"
11238529|NCT02464033|BG000|Baseline|GAD-Alum+Vitamin D+Etanercept|"All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.~GAD-Alum~Vitamin D~Etanercept"
11238530|NCT02464033|FG000|Participant Flow|GAD-Alum+Vitamin D+Etanercept|"All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.~GAD-Alum~Vitamin D~Etanercept"
11359660|NCT02949947|FG000|Participant Flow|Group A - Ferric Carboxymaltose|"Participants receive a Ferric Carboxymaltose injection by vein. Dose repeated 1 week later.~Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.~Ferric Carboxymaltose: 15 mg/kg by vein (up to 750 mg) over 15 min infusion. Dose repeated 1 week later.~Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24."
11359661|NCT02949947|FG001|Participant Flow|Group B - Iron Supplement|"Participants take iron supplements by mouth every day for up to 3 months.~Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.~Iron Supplements: Participants take iron supplements by mouth every day for up to 3 months.~Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24."
11359662|NCT02949947|OG000|Outcome|Group A - Ferric Carboxymaltose|"Participants receive a Ferric Carboxymaltose injection by vein. Dose repeated 1 week later.~Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.~Ferric Carboxymaltose: 15 mg/kg by vein (up to 750 mg) over 15 min infusion. Dose repeated 1 week later.~Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24."
11359663|NCT02949947|OG001|Outcome|Group B - Iron Supplement|"Participants take iron supplements by mouth every day for up to 3 months.~Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.~Iron Supplements: Participants take iron supplements by mouth every day for up to 3 months.~Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24."
11359664|NCT02949947|EG000|Reported Event|Group A - Ferric Carboxymaltose|"Participants receive a Ferric Carboxymaltose injection by vein. Dose repeated 1 week later.~Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.~Ferric Carboxymaltose: 15 mg/kg by vein (up to 750 mg) over 15 min infusion. Dose repeated 1 week later.~Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24."
11359665|NCT02949947|EG001|Reported Event|Group B - Iron Supplement|"Participants take iron supplements by mouth every day for up to 3 months.~Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.~Iron Supplements: Participants take iron supplements by mouth every day for up to 3 months.~Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24."
11359666|NCT02947100|BG000|Baseline|SCD-Omegatex™|"single arm~SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a 3+3 design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose."
11359667|NCT02947100|FG000|Participant Flow|SCD-Omegatex™|"single arm~SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a 3+3 design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose."
11359668|NCT02947100|OG000|Outcome|SCD-Omegatex™|"single arm~SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a 3+3 design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose."
11359669|NCT02947100|EG000|Reported Event|SCD-Omegatex™|"single arm~SCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a 3+3 design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose."
11359670|NCT02936206|BG000|Baseline|Fulvestrant|"750 mg injection in 3 divided doses~Fulvestrant: fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only"
11359671|NCT02936206|BG001|Baseline|Tamoxifen|"20mg orally~Tamoxifen: 14 days of treatment with tamoxifen 20mg orally each day"
11359672|NCT02936206|BG002|Baseline|Total|Total of all reporting groups
11359673|NCT02936206|FG000|Participant Flow|Fulvestrant|"750 mg injection in 3 divided doses~Fulvestrant: fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only"
11359674|NCT02936206|FG001|Participant Flow|Tamoxifen|"20mg orally~Tamoxifen: 14 days of treatment with tamoxifen 20mg orally each day"
11359675|NCT02936206|OG000|Outcome|Fulvestrant|"750 mg injection in 3 divided doses~Fulvestrant: fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only"
11359676|NCT02936206|OG001|Outcome|Tamoxifen|"20mg orally~Tamoxifen: 14 days of treatment with tamoxifen 20mg orally each day"
11359677|NCT02936206|EG000|Reported Event|Fulvestrant|"750 mg injection in 3 divided doses~Fulvestrant: fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only"
11359678|NCT02936206|EG001|Reported Event|Tamoxifen|"20mg orally~Tamoxifen: 14 days of treatment with tamoxifen 20mg orally each day"
11359679|NCT02934932|BG000|Baseline|All Participants|All participants who signed consent.
11359680|NCT02934932|FG000|Participant Flow|All Participants|All participants who began the study.
11359681|NCT02934932|OG000|Outcome|Brexpiprazole 2mg|"Subjects will be titrated to this dose of brexpiprazole for 6 weeks.~Brexpiprazole: Comparison of brexpiprazole to placebo"
11359682|NCT02934932|OG001|Outcome|Brexpiprazole 4mg|"Subjects will be titrated to this dose of brexpiprazole for 6 weeks.~Brexpiprazole: Comparison of brexpiprazole to placebo"
11359683|NCT02934932|OG002|Outcome|Placebo|"Subjects will be titrated to this dose of placebo for 6 weeks.~Brexpiprazole: Comparison of brexpiprazole to placebo"
11359684|NCT02934932|EG000|Reported Event|All Participants|All participants who began the study.
11359685|NCT02908516|BG000|Baseline|Tranexamic Acid|"Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.~Tranexamic Acid: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively."
11359686|NCT02908516|BG001|Baseline|Placebo|"Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.~Placebo: 2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively."
11359687|NCT02908516|BG002|Baseline|Total|Total of all reporting groups
11359688|NCT02908516|FG000|Participant Flow|Tranexamic Acid|"Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.~Tranexamic Acid: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively."
11359689|NCT02908516|FG001|Participant Flow|Placebo|"Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.~Placebo: 2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively."
11359690|NCT02908516|OG000|Outcome|Tranexamic Acid|"Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.~Tranexamic Acid: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively."
11359691|NCT02908516|OG001|Outcome|Placebo|"Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.~Placebo: 2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively."
11187144|NCT02104895|BG001|Baseline|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
11359692|NCT02908516|EG000|Reported Event|Tranexamic Acid|"Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.~Tranexamic Acid: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively."
11359693|NCT02908516|EG001|Reported Event|Placebo|"Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.~Placebo: 2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively."
11376222|NCT01267955|BG000|Baseline|Treatment (Vismodegib)|"Patients receive vismodegib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies~Vismodegib: Given PO"
11376223|NCT01267955|FG000|Participant Flow|Treatment (Vismodegib)|"Patients receive vismodegib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies~Vismodegib: Given PO~This is a single-arm phase 2 trial, based on a two-stage Simon's optimal design. Assuming 20% (H0: null hypothesis) and 40% (H1: alternative hypothesis) six-month CBR, 10% type I error rate and 90% power, 37 eligible and assessable patients were necessary (17 in the first stage and 20 in the second stage). At the second stage/final stage, GDC-0449 would be considered promising if at least eleven patients were progression-free at 6 months."
11376224|NCT01267955|OG000|Outcome|Treatment (Vismodegib)|"Patients receive vismodegib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies~Vismodegib: Given PO"
11376225|NCT01267955|EG000|Reported Event|Treatment (Vismodegib)|"Patients receive vismodegib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies~Vismodegib: Given PO"
11376226|NCT01253070|BG000|Baseline|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
11376227|NCT01253070|FG000|Participant Flow|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
11376228|NCT01253070|OG000|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
11359694|NCT02923830|BG000|Baseline|Control Group|"Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months~Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months"
11359695|NCT02923830|BG001|Baseline|Intervention Group|"Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.~Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only."
11359696|NCT02923830|BG002|Baseline|Total|Total of all reporting groups
11359697|NCT02923830|FG000|Participant Flow|Control Group|"Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months~Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months"
11359698|NCT02923830|FG001|Participant Flow|Intervention Group|"Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.~Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only."
11359699|NCT02923830|OG000|Outcome|Control Group|"Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months~Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months"
11359700|NCT02923830|OG001|Outcome|Intervention Group|"Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.~Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only."
11359701|NCT02923830|EG000|Reported Event|Control Group|"Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months~Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months"
11359702|NCT02923830|EG001|Reported Event|Intervention Group|"Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.~Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only."
11359703|NCT02920450|BG000|Baseline|Treatment Arm|"Gedatolisib, Paclitaxel, and Carboplatin~Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.~Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11359704|NCT02920450|FG000|Participant Flow|Treatment Arm (Phase 1b; Dose Level 1)|"Gedatolisib (Dose level 1[110 mg]), Paclitaxel, and Carboplatin~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11187145|NCT02104895|BG002|Baseline|Total|Total of all reporting groups
11187146|NCT02104895|FG000|Participant Flow|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
11359705|NCT02920450|FG001|Participant Flow|Treatment Arm (Phase 1b; Dose Level 2)|"Gedatolisib (Dose level 2[150 mg]), Paclitaxel, and Carboplatin~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11359706|NCT02920450|FG002|Participant Flow|Treatment Arm (Phase 1b; Dose Level 3)|"Gedatolisib (Dose level 2[180 mg]), Paclitaxel, and Carboplatin~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11359707|NCT02920450|FG003|Participant Flow|Treatment Arm (Phase 2)|"Gedatolisib (MTD From the Phase 1b portion), Paclitaxel, and Carboplatin~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11359708|NCT02920450|OG000|Outcome|Treatment Arm|"Gedatolisib, Paclitaxel, and Carboplatin~Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.~Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11376229|NCT01253070|OG001|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
11187147|NCT02104895|FG001|Participant Flow|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
11187148|NCT02104895|OG000|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
11187149|NCT02104895|OG001|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
11187150|NCT02104895|EG000|Reported Event|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
11187151|NCT02104895|EG001|Reported Event|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
11187152|NCT02104947|BG000|Baseline|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187153|NCT02104947|BG001|Baseline|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187154|NCT02104947|BG002|Baseline|Total|Total of all reporting groups
11187155|NCT02104947|FG000|Participant Flow|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187156|NCT02104947|FG001|Participant Flow|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187157|NCT02104947|OG000|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187158|NCT02104947|OG001|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187159|NCT02104947|OG000|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187160|NCT02104947|OG000|Outcome|ICH (Group A)|Group A patients with baseline intracranial hemorrhage (ICH).
10962037|NCT00864383|BG001|Baseline|Regimen 2 - 2MHRZ/2MHR (Isoniazid)|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
11187161|NCT02104947|OG001|Outcome|Non-ICH (Group A)|Group A patients with baseline non-intracranial hemorrhage (non-ICH).
11187162|NCT02104947|OG000|Outcome|Idarucizumab (Group A & B)|"In Group A the patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.~In Group B the patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes."
11187163|NCT02104947|EG000|Reported Event|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187164|NCT02104947|EG001|Reported Event|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
11187165|NCT02105012|BG000|Baseline|All Subjects|
11187166|NCT02105012|FG000|Participant Flow|All Subjects|
11187167|NCT02105012|OG000|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
11187168|NCT02105012|OG001|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
11187169|NCT02105012|OG002|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
11187170|NCT02105012|OG003|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
11187171|NCT02105012|OG004|Outcome|Placebo MDI|Placebo MDI.
11187172|NCT02105012|EG000|Reported Event|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
11187173|NCT02105012|EG001|Reported Event|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
11187174|NCT02105012|EG002|Reported Event|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
11187175|NCT02105012|EG003|Reported Event|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
11187176|NCT02105012|EG004|Reported Event|Placebo MDI|Placebo MDI.
11187177|NCT02105246|BG000|Baseline|Home-based|Referral to home-based cardiac rehabilitation (intervention): Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.
11187178|NCT02105246|BG001|Baseline|Center-based|Referral to center-based cardiac rehabilitation (standard of care): Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
11187179|NCT02105246|BG002|Baseline|Total|Total of all reporting groups
11187180|NCT02105246|FG000|Participant Flow|Referral to Home-based Cardiac Rehabilitation|Referral to home-based cardiac rehabilitation (intervention): Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.
11187181|NCT02105246|FG001|Participant Flow|Referral to Center-based Cardiac Rehabilitation|Referral to center-based cardiac rehabilitation (standard of care): Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
11187182|NCT02105246|OG000|Outcome|Referral to Home-based Cardiac Rehabilitation|"Referral to a home-based cardiac rehabilitation program (intervention).~Referral to home-based cardiac rehabilitation: Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes."
11187183|NCT02105246|OG001|Outcome|Referral to Center-based Cardiac Rehabilitation|"Referral to a center-based cardiac rehabilitation program (standard of care).~Referral to center-based cardiac rehabilitation: Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting."
11187184|NCT02105246|OG000|Outcome|Home-based Cardiac Rehabilitation Participants|Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.
11187185|NCT02105246|OG001|Outcome|Center-based Cardiac Rehabilitation Participants|Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
11187186|NCT02105246|OG000|Outcome|Referral to Home-based Cardiac Rehab|"Referral to a home-based cardiac rehabilitation program (intervention).~Referral to center-based cardiac rehab: Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting."
11187187|NCT02105246|OG001|Outcome|Referral to Center-based Cardiac Rehab|"Referral to a center-based cardiac rehabilitation program (standard of care).~Referral to home-based cardiac rehab: Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes."
11187188|NCT02105246|EG000|Reported Event|Referral to Home-based Cardiac Rehabilitation|"Referral to a home-based cardiac rehabilitation program (intervention).~Referral to home-based cardiac rehabilitation: Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes."
11187189|NCT02105246|EG001|Reported Event|Referral to Center-based Cardiac Rehabilitation|"Referral to a center-based cardiac rehabilitation program (standard of care).~Referral to center-based cardiac rehabilitation: Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting."
11187190|NCT02105272|BG000|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187191|NCT02105272|BG001|Baseline|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
11187192|NCT02105272|BG002|Baseline|Total|Total of all reporting groups
11187193|NCT02105272|FG000|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187194|NCT02105272|FG001|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
11187195|NCT02105272|OG000|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187196|NCT02105272|OG001|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
11187197|NCT02105272|EG000|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187198|NCT02105272|EG001|Reported Event|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
11187199|NCT02105285|BG000|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187200|NCT02105285|BG001|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
11187201|NCT02105285|BG002|Baseline|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
11187202|NCT02105285|BG003|Baseline|Total|Total of all reporting groups
11187203|NCT02105285|FG000|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187204|NCT02105285|FG001|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
11187205|NCT02105285|FG002|Participant Flow|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
11187206|NCT02105285|OG000|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187207|NCT02105285|OG001|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
11187208|NCT02105285|EG000|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187209|NCT02105285|EG001|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
11187210|NCT02105285|EG002|Reported Event|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
11187211|NCT02105324|BG000|Baseline|All Randomized Participants|All randomized participants who completed both periods of the study.
11187212|NCT02105324|FG000|Participant Flow|Bionic Pancreas Then Usual Care|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days in Period 1, followed by Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days in Period 2. There was a 3-day washout period between periods.
11187213|NCT02105324|FG001|Participant Flow|Usual Care Then Bionic Pancreas|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days in Period 1, followed by Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a CGM device, for 5 days in Period 2. There was a 3-day washout period between periods.
11187214|NCT02105324|OG000|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
11187215|NCT02105324|OG001|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
11187216|NCT02105324|OG000|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
11187217|NCT02105324|OG000|Outcome|Bionic Pancreas|Participants who were randomized and began in the trial
11187218|NCT02105324|OG000|Outcome|Bionic Pancreas|management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
11187219|NCT02105324|EG000|Reported Event|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
11187220|NCT02105324|EG001|Reported Event|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
11187221|NCT02105415|BG000|Baseline|Etomidate|Etomidate 0.15mg/kg weight based dose
11187222|NCT02105415|BG001|Baseline|Ketamine / Propofol Admixture|Ketamine / Propofol Admixture weight based dose 0.5 mg/kg ketamine and 0.5 mg/kg propofol
11187223|NCT02105415|BG002|Baseline|Total|Total of all reporting groups
11187224|NCT02105415|FG000|Participant Flow|Etomidate|Etomidate 0.15mg/kg weight based dose
11187225|NCT02105415|FG001|Participant Flow|Ketamine / Propofol Admixture|Ketamine / Propofol Admixture; weight based dose 0.5 mg/kg ketamine and 0.5 mg/kg propofol.
11187226|NCT02105415|OG000|Outcome|Etomidate|Etomidate 0.15mg/kg weight based dose
11187227|NCT02105415|OG001|Outcome|Ketamine / Propofol Admixture|Ketamine / Propofol Admixture weight based dose 0.5 mg/kg ketamine and 0.5 mg/kg propofol
11187228|NCT02105415|OG001|Outcome|Ketamine / Propofol Admixture|Ketamine / Propofol Admixture; weight based dose 0.5 mg/kg ketamine and 0.5 mg/kg propofol.
11187229|NCT02105415|OG000|Outcome|Etomidate (3-5 Hours)|Cortisol levels at 3-5 hours
11187230|NCT02105415|OG001|Outcome|Ketamine/Propofol Admixture (3-5 Hours)|Cortisol levels at 3-5 hours
11187231|NCT02105415|OG002|Outcome|Etomidate (23-25 Hours)|Cortisol levels at 23-25 hours
11187232|NCT02105415|OG003|Outcome|Ketamine/Propofol Admixture (23-25 Hours)|Cortisol levels at 23-25 hours
11187233|NCT02105415|EG000|Reported Event|Etomidate|Etomidate 0.15mg/kg weight based dose
11187234|NCT02105415|EG001|Reported Event|Ketamine / Propofol Admixture|Ketamine / Propofol Admixture weight based dose 0.5 mg/kg ketamine and 0.5 mg/kg propofol
11187235|NCT02105454|BG000|Baseline|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
11187236|NCT02105454|FG000|Participant Flow|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
11187237|NCT02105454|OG000|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
10962038|NCT00864383|BG002|Baseline|Regimen 3 - 2EMRZ/2MR (Ethambutol)|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
10962039|NCT00864383|BG003|Baseline|Total|Total of all reporting groups
10962040|NCT00864383|FG000|Participant Flow|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
10962041|NCT00864383|FG001|Participant Flow|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
10962042|NCT00864383|FG002|Participant Flow|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
10962043|NCT00864383|OG000|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
11187238|NCT02105454|EG000|Reported Event|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
11187239|NCT02105467|BG000|Baseline|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
11187240|NCT02105467|BG001|Baseline|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
11187241|NCT02105467|BG002|Baseline|Total|Total of all reporting groups
11187242|NCT02105467|FG000|Participant Flow|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks (Period 1), followed by a 24-week follow-up period (Period 2)
11187243|NCT02105467|FG001|Participant Flow|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks (Period 1), followed by a 4-week unblinding/washout period and 12 weeks of open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily (Period 2), followed by a 24-week follow-up period (Period 3).
11187244|NCT02105467|OG000|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
11187245|NCT02105467|OG001|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
11187246|NCT02105467|EG000|Reported Event|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period. Adverse event reporting covers Day 1 through Week 36.
11187247|NCT02105467|EG001|Reported Event|Deferred Treatment Group (Blinded Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Day 1 through Week 16.
11359709|NCT02920450|EG000|Reported Event|Treatment Arm (Phase 1b; Gedatolisib Dose Level 1[110 mg])|"Gedatolisib, Paclitaxel, and Carboplatin~Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.~Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11359710|NCT02920450|EG001|Reported Event|Treatment Arm (Phase 1b; Gedatolisib Dose Level 2[150 mg])|"Gedatolisib, Paclitaxel, and Carboplatin~Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.~Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11359711|NCT02920450|EG002|Reported Event|Treatment Arm (Phase 1b; Gedatolisib Dose Level 3[180 mg])|"Gedatolisib, Paclitaxel, and Carboplatin~Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.~Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11359712|NCT02920450|EG003|Reported Event|Treatment Arm (Phase 2; MTD of Gedatolisib From Phase Ib)|"Gedatolisib, Paclitaxel, and Carboplatin~Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.~Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg~Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.~Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design."
11359713|NCT02920177|BG000|Baseline|Platelet-rich Plasma|platelet-rich plasma injection into the head-neck junction of the hip joint
11359714|NCT02920177|BG001|Baseline|Kenalog 10 mg/mL Injectable Suspension|corticosteroid injection into the head-neck junction of the hip joint
11359715|NCT02920177|BG002|Baseline|Total|Total of all reporting groups
11359716|NCT02920177|FG000|Participant Flow|Platelet-rich Plasma|platelet-rich plasma injection into the head-neck junction of the hip joint
11359717|NCT02920177|FG001|Participant Flow|Kenalog 10 mg/mL Injectable Suspension|corticosteroid injection into the head-neck junction of the hip joint
11359718|NCT02920177|OG000|Outcome|Platelet-rich Plasma|platelet-rich plasma injection into the head-neck junction of the hip joint
11359719|NCT02920177|OG001|Outcome|Kenalog 10 mg/mL Injectable Suspension|corticosteroid injection into the head-neck junction of the hip joint
11359720|NCT02920177|EG000|Reported Event|Platelet-rich Plasma|platelet-rich plasma injection into the head-neck junction of the hip joint
11359721|NCT02920177|EG001|Reported Event|Kenalog 10 mg/mL Injectable Suspension|corticosteroid injection into the head-neck junction of the hip joint
11359722|NCT02926638|BG000|Baseline|Arm I (Rilotumumab, Erlotinib)|"Patients receive rilotumumab IV over 60-120 minutes on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Rilotumumab: Given IV"
11359723|NCT02926638|BG001|Baseline|Arm II (Erlotinib)|"Patients receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11359724|NCT02926638|BG002|Baseline|Total|Total of all reporting groups
11359725|NCT02926638|FG000|Participant Flow|Arm I (Rilotumumab, Erlotinib)|"Patients receive rilotumumab IV over 60-120 minutes on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Rilotumumab: Given IV"
11359726|NCT02926638|FG001|Participant Flow|Arm II (Erlotinib)|"Patients receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11359727|NCT02926638|OG000|Outcome|Arm I (Rilotumumab, Erlotinib)|"Patients receive rilotumumab IV over 60-120 minutes on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Rilotumumab: Given IV"
11238531|NCT02464033|OG000|Outcome|GAD-Alum+Vitamin D+Etanercept|"All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.~GAD-Alum~Vitamin D~Etanercept"
11238532|NCT02464033|OG000|Outcome|GAD-Alum+Vitamin D+Etanercept|"All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.~GAD-Alum~Vitamin D~Etanercept"
11238533|NCT02464033|EG000|Reported Event|GAD-Alum+Vitamin D+Etanercept|"All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.~GAD-Alum~Vitamin D~Etanercept"
11238534|NCT02464059|BG000|Baseline|Vitamin D3|"Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks~Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels."
11238535|NCT02464059|FG000|Participant Flow|Vitamin D3|"Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks~Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels."
11238536|NCT02464059|OG000|Outcome|Vitamin D3|"Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks~Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels."
11238537|NCT02464059|EG000|Reported Event|Vitamin D3|"Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks~Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels."
11238538|NCT02464163|BG000|Baseline|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238539|NCT02464163|BG001|Baseline|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238540|NCT02464163|BG002|Baseline|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238541|NCT02464163|BG003|Baseline|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
11238542|NCT02464163|BG004|Baseline|Total|Total of all reporting groups
11238543|NCT02464163|FG000|Participant Flow|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238544|NCT02464163|FG001|Participant Flow|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238545|NCT02464163|FG002|Participant Flow|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238546|NCT02464163|FG003|Participant Flow|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
11238547|NCT02464163|OG000|Outcome|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238548|NCT02464163|OG001|Outcome|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238549|NCT02464163|OG002|Outcome|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238550|NCT02464163|OG003|Outcome|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
11238551|NCT02464163|EG000|Reported Event|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238552|NCT02464163|EG001|Reported Event|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238553|NCT02464163|EG002|Reported Event|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
11238554|NCT02464163|EG003|Reported Event|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
11336609|NCT03569098|EG003|Reported Event|Open-Label Treatment Period (Cycle 2): Dysport 300 U|"On Cycle 2 Day 1 in the open-label treatment period, all participants who met retreatment criteria received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11359728|NCT02926638|OG001|Outcome|Arm II (Erlotinib)|"Patients receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11359729|NCT02926638|EG000|Reported Event|Arm I (Rilotumumab, Erlotinib)|"Patients receive rilotumumab IV over 60-120 minutes on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Rilotumumab: Given IV"
11359730|NCT02926638|EG001|Reported Event|Arm II (Erlotinib)|"Patients receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11359731|NCT02920242|BG000|Baseline|Rifaximin|Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
11359732|NCT02920242|BG001|Baseline|Xifaxan|Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
11359733|NCT02920242|BG002|Baseline|Placebo|Patients received placebo tablet 3 times per day for 3 days.
11359734|NCT02920242|BG003|Baseline|Total|Total of all reporting groups
11359735|NCT02920242|FG000|Participant Flow|Rifaximin|Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
11359736|NCT02920242|FG001|Participant Flow|Xifaxan|Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
11359737|NCT02920242|FG002|Participant Flow|Placebo|Patients received placebo tablet 3 times per day for 3 days.
11359738|NCT02920242|OG000|Outcome|Rifaximin|Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
11359739|NCT02920242|OG001|Outcome|Xifaxan|Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
11359740|NCT02920242|OG002|Outcome|Placebo|Patients received placebo tablet 3 times per day for 3 days.
11359741|NCT02920242|EG000|Reported Event|Rifaximin|Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
11359742|NCT02920242|EG001|Reported Event|Xifaxan|Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
11359743|NCT02920242|EG002|Reported Event|Placebo|Patients received placebo tablet 3 times per day for 3 days.
11359744|NCT02900781|BG000|Baseline|Active Comparator Steprite™ Device'|"steprite™ device active Comparator- The steprite™ System is a monitoring and biofeedback system for the Monitoring of rehabilitation patients Measuring pressure distribution, gait and range of motion of the lower extremities while a patient performs specified rehabilitation exercises~Steprite™: Steprite™ Device shoe insert monitoring device"
11359745|NCT02900781|BG001|Baseline|Control|"Control outcomes with no device. Standard of care physical therapy and outcomes.~Standard of care: No Device. Standard of care physical therapy"
11359746|NCT02900781|BG002|Baseline|Total|Total of all reporting groups
11359747|NCT02900781|FG000|Participant Flow|Control|"Control outcomes with no device. Standard of care physical therapy and outcomes.~Standard of care: No Device. Standard of care physical therapy"
11359748|NCT02900781|FG001|Participant Flow|Device|Device group- Standard of Care with the device
11359749|NCT02900781|OG000|Outcome|Control|control group
11359750|NCT02900781|OG001|Outcome|StepRite Device|Device group
11359751|NCT02900781|EG000|Reported Event|Control|Control group
11359752|NCT02900781|EG001|Reported Event|Device|Device group
11359753|NCT02892500|BG000|Baseline|Bupivacaine Hydrochloride and Betamethasone Sodium Phosphate|"When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed the area will be injected with a mixture of 5 ml of 0.25 % bupivacaine hydrochloride and 2 ml of 3 mg/ml betamethasone sodium phosphate (Celestone® Soluspan®) (BTM)~bupivacaine hydrochloride and betamethasone sodium phosphate: 5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament"
11359754|NCT02892500|BG001|Baseline|Bupivacaine Hydrochloride|"When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed, the area will be injected with 5ml of bupivacaine hydrochloride.~bupivacaine hydrochloride: 5ml of bupivacaine hydrochloride into the tibiofibular ligament"
11359755|NCT02892500|BG002|Baseline|Total|Total of all reporting groups
11359756|NCT02892500|FG000|Participant Flow|Bupivacaine Hydrochloride and Betamethasone Sodium Phosphate|"When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed the area will be injected with a mixture of 5 ml of 0.25 % bupivacaine hydrochloride and 2 ml of 3 mg/ml betamethasone sodium phosphate (Celestone® Soluspan®) (BTM)~bupivacaine hydrochloride and betamethasone sodium phosphate: 5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament"
11359757|NCT02892500|FG001|Participant Flow|Bupivacaine Hydrochloride|"When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed, the area will be injected with 5ml of bupivacaine hydrochloride.~bupivacaine hydrochloride: 5ml of bupivacaine hydrochloride into the tibiofibular ligament"
11187248|NCT02105467|EG002|Reported Event|Deferred Treatment Group (Open-label Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Week 16 through Week 52.
11187249|NCT02105558|BG000|Baseline|Epidural Anesthesia|￼An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
11187250|NCT02105558|BG001|Baseline|Combined Spinal and Epidural (CSE) Anesthesia|"A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.~The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr."
11187251|NCT02105558|BG002|Baseline|Total|Total of all reporting groups
11187252|NCT02105558|FG000|Participant Flow|Epidural Anesthesia|￼An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
11187253|NCT02105558|FG001|Participant Flow|Combined Spinal and Epidural (CSE) Anesthesia|"A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.~The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr."
11187254|NCT02105558|OG000|Outcome|Epidural Anesthesia|￼An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
11187255|NCT02105558|OG001|Outcome|Combined Spinal and Epidural (CSE) Anesthesia|"A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.~The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr."
11187256|NCT02105558|EG000|Reported Event|Epidural Anesthesia|￼An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
11187257|NCT02105558|EG001|Reported Event|Combined Spinal and Epidural (CSE) Anesthesia|"A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.~The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr."
11187258|NCT02105662|BG000|Baseline|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
11187259|NCT02105662|FG000|Participant Flow|Grazoprevir+Elbasvir|Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
11187260|NCT02105662|OG000|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
11187261|NCT02105662|EG000|Reported Event|Grazoprevir + Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
11187262|NCT02105688|BG000|Baseline|Immediate Treatment Arm: Grazoprevir/Elbasvir|In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
11187263|NCT02105688|BG001|Baseline|Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir|In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
11187264|NCT02105688|BG002|Baseline|Total|Total of all reporting groups
11187265|NCT02105688|FG000|Participant Flow|Immediate Treatment Arm: Grazoprevir/Elbasvir|In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
11187266|NCT02105688|FG001|Participant Flow|Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir|In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
11187267|NCT02105688|OG000|Outcome|Immediate Treatment Arm: Grazoprevir/Elbasvir|In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
11187268|NCT02105688|OG001|Outcome|Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir|In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
11187269|NCT02105688|EG000|Reported Event|Immediate Treatment Arm: Grazoprevir/Elbasvir|In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
11187270|NCT02105688|EG001|Reported Event|Deferred Treatment Arm: Placebo|In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up.
11187271|NCT02105688|EG002|Reported Event|Deferred Treatment Arm: Grazoprevir/Elbasvir|In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
11187272|NCT02105701|BG000|Baseline|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
11187273|NCT02105701|BG001|Baseline|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
11187274|NCT02105701|BG002|Baseline|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
11187275|NCT02105701|BG003|Baseline|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
11187276|NCT02105701|BG004|Baseline|Total|Total of all reporting groups
11187277|NCT02105701|FG000|Participant Flow|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
11187278|NCT02105701|FG001|Participant Flow|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
11187279|NCT02105701|FG002|Participant Flow|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
11187280|NCT02105701|FG003|Participant Flow|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
11187281|NCT02105701|OG000|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
11187282|NCT02105701|OG001|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
11187283|NCT02105701|OG002|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
11187284|NCT02105701|OG003|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
11187285|NCT02105701|EG000|Reported Event|GZR/EBR 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
11187286|NCT02105701|EG001|Reported Event|GZR/EBR + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
11187287|NCT02105701|EG002|Reported Event|GZR/EBR 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
11376230|NCT01253070|EG000|Reported Event|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
11187288|NCT02105701|EG003|Reported Event|GZR/EBR + RBV for 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
11187289|NCT02105740|BG000|Baseline|Hypnosis|"Use of hypnosis to reduct the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
11187290|NCT02105740|BG001|Baseline|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.~Control : The control and experimental groups respond in 3 different moments to Visual Analog Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting was made before the hypnosis. In the second meeting, within an interval of 7 days, the scales were applied in all patients. Before applying the scales, the hypnosis group was submitted to the session. The third meeting occurred two weeks later, where the scales were only applied to compare the groups."
11187291|NCT02105740|BG002|Baseline|Total|Total of all reporting groups
11187292|NCT02105740|FG000|Participant Flow|Hypnosis|"Use of hypnosis in the reduction of the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression."
11187293|NCT02105740|FG001|Participant Flow|Control|"Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain, anxiety and depression with the application of the scales.~Control x Hypnosis Group: The control and hypnosis groups respond in 3 different distinct moments, with the Visual Analogue Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group, after the follow-up visit. The third evaluation will occur two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety."
11187294|NCT02105740|OG000|Outcome|Hypnosis|"Use of hypnosis to change the levels of pain.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms."
11187295|NCT02105740|OG001|Outcome|Control|"Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain with the application of the Visual Analogue Scale (VAS).~Control x Hypnosis Group: The control and the hypnosis groups respond in 3 different distinct moments, using the Visual Analogue Scale (VAS) to evaluate the pain. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was made two weeks later, in order to provide a follow-up to assess the efficacy of the technique."
11187296|NCT02105740|OG000|Outcome|Hypnosis|"Use of hypnosis in the reduction of the levels depression and anxiety.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
11187297|NCT02105740|OG001|Outcome|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding anxiety and depression with the application of the Hospital Anxiety and Depression Scale (HADS).~Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Hospital Anxiety and Depression Scale (HADS) to evaluate depression and anxiety. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group was compared in relation to the intensity of the depression and anxiety"
11187298|NCT02105740|EG000|Reported Event|Hypnosis|"Use of hypnosis in the reduction of the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
11187299|NCT02105740|EG001|Reported Event|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.~Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Visual Analog Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation will be two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety"
11187300|NCT02105948|BG000|Baseline|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11238555|NCT02464176|BG000|Baseline|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. The block will be tested for block success. Testing will be performed with a 25 gauge Whitacre needle . The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed."
11238556|NCT02464176|BG001|Baseline|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. The block will be tested for block success. Testing will be performed with a 25 gauge Whitacre needle . The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed."
11238557|NCT02464176|BG002|Baseline|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
11238558|NCT02464176|BG003|Baseline|Total|Total of all reporting groups
11238559|NCT02464176|FG000|Participant Flow|4 mg Dexamethasone Group|Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.
11238560|NCT02464176|FG001|Participant Flow|8 mg Dexamethasone Group|Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.
11238561|NCT02464176|FG002|Participant Flow|Control Group|Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.
11238562|NCT02464176|OG000|Outcome|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle"
11238563|NCT02464176|OG001|Outcome|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken"
11238564|NCT02464176|OG002|Outcome|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
11238565|NCT02464176|EG000|Reported Event|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle"
11238566|NCT02464176|EG001|Reported Event|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken"
11238567|NCT02464176|EG002|Reported Event|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
11238568|NCT02464449|BG000|Baseline|AI CBT|"AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.~Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model."
11238569|NCT02464449|BG001|Baseline|Standard Telephone CBT|"Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.~Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook."
11238570|NCT02464449|BG002|Baseline|Total|Total of all reporting groups
11238571|NCT02464449|FG000|Participant Flow|AI CBT|"AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.~Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model."
11238572|NCT02464449|FG001|Participant Flow|Standard Telephone CBT|"Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.~Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook."
11238573|NCT02464449|OG000|Outcome|AI CBT|"AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.~Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model."
11238574|NCT02464449|OG001|Outcome|Standard Telephone CBT|"Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.~Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook."
11238575|NCT02464449|EG000|Reported Event|AI CBT|"AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.~Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model."
11238576|NCT02464449|EG001|Reported Event|Standard Telephone CBT|"Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.~Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook."
11238577|NCT02464540|BG000|Baseline|Light-cured Resin Cement - Light-cured Flowable Composite|Ceramic restorations were cemented using translucent shade of photoactivated resin cement or Light-cured flowable composite. Participants enrolled in both arms, luting material to be used was randomly selected.
11238578|NCT02464540|FG000|Participant Flow|Light-cured Resin Cement|Ceramic restorations were cemented using translucent shade of photoactivated resin cement (RelyX Veneer; 3M ESPE).
11238579|NCT02464540|FG001|Participant Flow|Light-cured Flowable Composite|Ceramic restorations were cemented using translucent shade of flowable composite (Tetric N-Flow; Ivoclar Vivadent AG)
11238580|NCT02464540|OG000|Outcome|Light-cured Resin Cement|Color change was estimated by calculating the CIEDE2000 formula. Corresponding ΔE00 values for perceptibility and acceptability were 0.8 and 1.8, respectively. (Paravina, 2015)
11238581|NCT02464540|OG001|Outcome|Light-cured Flowable Composite|Color change was estimated by calculating the CIEDE2000 formula. Corresponding ΔE00 values for perceptibility and acceptability were 0.8 and 1.8, respectively. (Paravina, 2015)
11238582|NCT02464540|EG000|Reported Event|Light-cured Resin Cement|Ceramic restorations were cemented using translucent shade of photoactivated resin cement.
11238583|NCT02464540|EG001|Reported Event|Light-cured Flowable Composite|Ceramic restorations were cemented using translucent shade of photoactivated flowable composite.
11240790|NCT02481869|EG001|Reported Event|Saline|"At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.~Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.~Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.~Arthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation"
11238584|NCT02464657|BG000|Baseline|Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine|"Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238585|NCT02464657|BG001|Baseline|Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine|"Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle."
11238586|NCT02464657|BG002|Baseline|Ph 2 - Nivolumab + Idarubicin + Cytarabine|"Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238587|NCT02464657|BG003|Baseline|Total|Total of all reporting groups
11238588|NCT02464657|FG000|Participant Flow|Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine|"Phase I starting dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238589|NCT02464657|FG001|Participant Flow|Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine|"Phase I starting dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238590|NCT02464657|FG002|Participant Flow|Ph 2 - Nivolumab + Idarubicin + Cytarabine|"Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11240791|NCT02481934|BG000|Baseline|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive: two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
11187301|NCT02105948|BG001|Baseline|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187302|NCT02105948|BG002|Baseline|Placebo - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187303|NCT02105948|BG003|Baseline|Mepolizumab 100 mg - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187304|NCT02105948|BG004|Baseline|Total|Total of all reporting groups
11187305|NCT02105948|FG000|Participant Flow|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells per microliter (cells/µL) at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their standard of care (SoC) therapy. Salbutamol metered dose inhaler (MDI) was issued for use as rescue medication throughout the study.
11187306|NCT02105948|FG001|Participant Flow|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187307|NCT02105948|FG002|Participant Flow|Placebo - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187308|NCT02105948|FG003|Participant Flow|Mepolizumab 100 mg - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187309|NCT02105948|OG000|Outcome|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187310|NCT02105948|OG001|Outcome|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187311|NCT02105948|OG000|Outcome|Placebo|Participants were randomized to and received Placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187312|NCT02105948|OG001|Outcome|Mepolizumab 100 mg|Participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187313|NCT02105948|OG000|Outcome|Placebo|Participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187314|NCT02105948|EG000|Reported Event|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187315|NCT02105948|EG001|Reported Event|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187316|NCT02105948|EG002|Reported Event|Placebo - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187317|NCT02105948|EG003|Reported Event|Mepolizumab 100 mg - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187318|NCT02105961|BG000|Baseline|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11359758|NCT02892500|OG000|Outcome|Bupivacaine Hydrochloride and Betamethasone Sodium Phosphate|"When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed the area will be injected with a mixture of 5 ml of 0.25 % bupivacaine hydrochloride and 2 ml of 3 mg/ml betamethasone sodium phosphate (Celestone® Soluspan®) (BTM)~bupivacaine hydrochloride and betamethasone sodium phosphate: 5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament"
11359759|NCT02892500|OG001|Outcome|Bupivacaine Hydrochloride|"When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed, the area will be injected with 5ml of bupivacaine hydrochloride.~bupivacaine hydrochloride: 5ml of bupivacaine hydrochloride into the tibiofibular ligament"
11359760|NCT02892500|EG000|Reported Event|Bupivacaine Hydrochloride and Betamethasone Sodium Phosphate|"When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed the area will be injected with a mixture of 5 ml of 0.25 % bupivacaine hydrochloride and 2 ml of 3 mg/ml betamethasone sodium phosphate (Celestone® Soluspan®) (BTM)~bupivacaine hydrochloride and betamethasone sodium phosphate: 5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament"
11359761|NCT02892500|EG001|Reported Event|Bupivacaine Hydrochloride|"When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed, the area will be injected with 5ml of bupivacaine hydrochloride.~bupivacaine hydrochloride: 5ml of bupivacaine hydrochloride into the tibiofibular ligament"
11359762|NCT02904356|BG000|Baseline|Brainsway H-coil for rTMS|"Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.~Repetitive transcranial magnetic stimulation: High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT)."
11359763|NCT02904356|FG000|Participant Flow|Brainsway H-coil for rTMS|"Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.~Repetitive transcranial magnetic stimulation: High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT)."
11359764|NCT02904356|OG000|Outcome|Brainsway H-coil for rTMS|"Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.~Repetitive transcranial magnetic stimulation: High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT)."
11359765|NCT02904356|EG000|Reported Event|Brainsway H-coil for rTMS|"Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.~Repetitive transcranial magnetic stimulation: High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT)."
11359766|NCT02899728|BG000|Baseline|Arm I (Chemotherapy, Cediranib Maleate, Olaparib)|"Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive maintenance therapy or no maintenance therapy. Patients in Arm II are assigned to receive maintenance therapy.~MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.~NO MAINTENANCE THERAPY: Patients are eligible to crossover to receive treatment with cediranib maleate and olaparib upon disease progression at the treating investigator's discretion.~Carboplatin: Given IV~Cediranib: Given PO~Cediranib Maleate: Given PO~Cisplatin: Given IV~Etoposide: Given IV~Olaparib: Given PO"
11359767|NCT02899728|BG001|Baseline|Arm II (Chemotherapy, Cediranib Maleate, Olaparib)|"Patients receive treatment as in Arm I and also receive cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.~Carboplatin: Given IV~Cediranib: Given PO~Cediranib Maleate: Given PO~Cisplatin: Given IV~Etoposide: Given IV~Olaparib: Given PO"
11359768|NCT02899728|BG002|Baseline|Total|Total of all reporting groups
11359769|NCT02899728|FG000|Participant Flow|Arm I (Chemotherapy, Cediranib Maleate, Olaparib)|"Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive maintenance therapy or no maintenance therapy. Patients in Arm II are assigned to receive maintenance therapy.~MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.~NO MAINTENANCE THERAPY: Patients are eligible to crossover to receive treatment with cediranib maleate and olaparib upon disease progression at the treating investigator's discretion.~Carboplatin: Given IV~Cediranib: Given PO~Cediranib Maleate: Given PO~Cisplatin: Given IV~Etoposide: Given IV~Olaparib: Given PO"
11187319|NCT02105961|BG001|Baseline|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187320|NCT02105961|BG002|Baseline|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187321|NCT02105961|BG003|Baseline|Total|Total of all reporting groups
11187322|NCT02105961|FG000|Participant Flow|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their standard of care (SoC) therapy. Salbutamol metered dose inhaler (MDI) was issued for use as rescue medication throughout the study.
11187323|NCT02105961|FG001|Participant Flow|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187324|NCT02105961|FG002|Participant Flow|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187325|NCT02105961|OG000|Outcome|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187326|NCT02105961|OG001|Outcome|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187327|NCT02105961|OG002|Outcome|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187328|NCT02105961|OG002|Outcome|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187329|NCT02105961|EG000|Reported Event|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187330|NCT02105961|EG001|Reported Event|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187331|NCT02105961|EG002|Reported Event|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
11187332|NCT02105974|BG000|Baseline|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
11187333|NCT02105974|BG001|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
11187334|NCT02105974|BG002|Baseline|Total|Total of all reporting groups
11187335|NCT02105974|FG000|Participant Flow|Placebo Run-In|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
11187336|NCT02105974|FG001|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
11187337|NCT02105974|FG002|Participant Flow|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
11187338|NCT02105974|OG000|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
11187339|NCT02105974|OG001|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
11187340|NCT02105974|EG000|Reported Event|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
11359770|NCT02899728|FG001|Participant Flow|Arm II (Chemotherapy, Cediranib Maleate, Olaparib)|"Patients receive treatment as in Arm I and also receive cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.~Carboplatin: Given IV~Cediranib: Given PO~Cediranib Maleate: Given PO~Cisplatin: Given IV~Etoposide: Given IV~Olaparib: Given PO"
11359771|NCT02899728|OG000|Outcome|Arm I (Chemotherapy, Cediranib Maleate, Olaparib)|"Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive maintenance therapy or no maintenance therapy. Patients in Arm II are assigned to receive maintenance therapy.~MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.~NO MAINTENANCE THERAPY: Patients are eligible to crossover to receive treatment with cediranib maleate and olaparib upon disease progression at the treating investigator's discretion.~Carboplatin: Given IV~Cediranib: Given PO~Cediranib Maleate: Given PO~Cisplatin: Given IV~Etoposide: Given IV~Olaparib: Given PO"
11359772|NCT02899728|OG001|Outcome|Arm II (Chemotherapy, Cediranib Maleate, Olaparib)|"Patients receive treatment as in Arm I and also receive cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.~Carboplatin: Given IV~Cediranib: Given PO~Cediranib Maleate: Given PO~Cisplatin: Given IV~Etoposide: Given IV~Olaparib: Given PO"
11359773|NCT02899728|EG000|Reported Event|Arm I (Chemotherapy, Cediranib Maleate, Olaparib)|"Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive maintenance therapy or no maintenance therapy. Patients in Arm II are assigned to receive maintenance therapy.~MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.~NO MAINTENANCE THERAPY: Patients are eligible to crossover to receive treatment with cediranib maleate and olaparib upon disease progression at the treating investigator's discretion.~Carboplatin: Given IV~Cediranib: Given PO~Cediranib Maleate: Given PO~Cisplatin: Given IV~Etoposide: Given IV~Olaparib: Given PO"
11359774|NCT02899728|EG001|Reported Event|Arm II (Chemotherapy, Cediranib Maleate, Olaparib)|"Patients receive treatment as in Arm I and also receive cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.~Carboplatin: Given IV~Cediranib: Given PO~Cediranib Maleate: Given PO~Cisplatin: Given IV~Etoposide: Given IV~Olaparib: Given PO"
11359775|NCT02875067|BG000|Baseline|Pembrolizumab and Lenalidomide|"An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions~Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days~Pembrolizumab~Lenalidomide"
11359776|NCT02875067|FG000|Participant Flow|Pembrolizumab and Lenalidomide|"An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions~Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days~Pembrolizumab~Lenalidomide"
11359777|NCT02875067|OG000|Outcome|Pembrolizumab and Lenalidomide|"An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions~Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days~Pembrolizumab~Lenalidomide"
11359778|NCT02875067|EG000|Reported Event|Pembrolizumab and Lenalidomide|"An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions~Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days~Pembrolizumab~Lenalidomide"
11359779|NCT02877732|BG000|Baseline|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
11359780|NCT02877732|BG001|Baseline|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
11359781|NCT02877732|BG002|Baseline|Total|Total of all reporting groups
11359782|NCT02877732|FG000|Participant Flow|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
11359783|NCT02877732|FG001|Participant Flow|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
11359784|NCT02877732|OG000|Outcome|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
11359785|NCT02877732|OG001|Outcome|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
11359786|NCT02877732|EG000|Reported Event|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
11359787|NCT02877732|EG001|Reported Event|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
11187341|NCT02105974|EG001|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
11359788|NCT02860169|BG000|Baseline|Healthy Participants|Eligible healthy participants were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and visual analogue scale (VAS), Cognitive Function Assessment, Reaction time (RTI), Attention switching task (AST), Emotional recognition task (ERT) , Rapid visual information processing (RVP).
11359789|NCT02860169|BG001|Baseline|Participants With Cold and Flu|Eligible participants with cold and flu were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP
10962044|NCT00864383|OG001|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
10962045|NCT00864383|OG002|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
10962046|NCT00864383|EG000|Reported Event|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
10962047|NCT00864383|EG001|Reported Event|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
10962048|NCT00864383|EG002|Reported Event|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
11187342|NCT02105987|BG000|Baseline|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
11359790|NCT02860169|BG002|Baseline|Total|Total of all reporting groups
11359791|NCT02860169|FG000|Participant Flow|Overall Participants|The study consisted of three parts A (includes only healthy participants), B and C (both B and C included healthy and cold and flu participants). Recruitment is done separately for each part of the study, based on the inclusion and exclusion criteria set for the respective part of the study.
10962049|NCT00864513|BG000|Baseline|Chemotherapy|pemetrexed
11187343|NCT02105987|BG001|Baseline|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
11187344|NCT02105987|BG002|Baseline|Total|Total of all reporting groups
11359792|NCT02860169|OG000|Outcome|Participants With Cold and Flu|Eligible participants with cold and flu were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP
11359793|NCT02860169|OG001|Outcome|Healthy Participants|Eligible healthy participants were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP
11359794|NCT02860169|EG000|Reported Event|Participants With Cold and Flu|Eligible participants with cold and flu were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP
11359795|NCT02860169|EG001|Reported Event|Healthy Participants|Eligible healthy participants were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP
11359796|NCT02865395|BG000|Baseline|Pre-operative Suppository|"A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.~Belladonna and Opium Suppository"
11359797|NCT02865395|BG001|Baseline|Post-operative Suppository|"A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.~Belladonna and Opium Suppository"
11359798|NCT02865395|BG002|Baseline|Rectal Exam|"Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.~Rectal Exam"
11359799|NCT02865395|BG003|Baseline|Total|Total of all reporting groups
11359800|NCT02865395|FG000|Participant Flow|Pre-operative Suppository|"A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.~Belladonna and Opium Suppository"
11359801|NCT02865395|FG001|Participant Flow|Post-operative Suppository|"A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.~Belladonna and Opium Suppository"
10962050|NCT00864513|FG000|Participant Flow|Chemotherapy|Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
10962051|NCT00864513|OG000|Outcome|Chemotherapy|pemetrexed
11187345|NCT02105987|FG000|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks.
11187346|NCT02105987|FG001|Participant Flow|Current ART|Participants continued on their current ART regimen for 24 weeks.
10962052|NCT00864513|EG000|Reported Event|Chemotherapy|pemetrexed
10962053|NCT00864539|BG000|Baseline|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
11187347|NCT02105987|FG002|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch|Participants who completed early switch phase continued to receive ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for an additional 24 weeks.
11359802|NCT02865395|FG002|Participant Flow|Rectal Exam|"Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.~Rectal Exam"
10962054|NCT00864539|BG001|Baseline|Plain Milk|daily intake of 200 mL plain milk
10962055|NCT00864539|BG002|Baseline|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
10962056|NCT00864539|BG003|Baseline|Plain Juice|subjects receiving plain orange juice
10962057|NCT00864539|BG004|Baseline|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
10962058|NCT00864539|BG005|Baseline|Placebo|Subjects receiving daily placebo containing 1 g starch
10962059|NCT00864539|BG006|Baseline|Total|Total of all reporting groups
10962060|NCT00864539|FG000|Participant Flow|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
10962061|NCT00864539|FG001|Participant Flow|Plain Milk|daily intake of 200 mL plain milk
10962062|NCT00864539|FG002|Participant Flow|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
11359803|NCT02865395|OG000|Outcome|Pre-operative Suppository|"A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.~Belladonna and Opium Suppository"
11359804|NCT02865395|OG001|Outcome|Post-operative Suppository|"A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.~Belladonna and Opium Suppository"
11359805|NCT02865395|OG002|Outcome|Rectal Exam|"Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.~Rectal Exam"
11359806|NCT02865395|EG000|Reported Event|Pre-operative Suppository|"A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.~Belladonna and Opium Suppository"
11359807|NCT02865395|EG001|Reported Event|Post-operative Suppository|"A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.~Belladonna and Opium Suppository"
11359808|NCT02865395|EG002|Reported Event|Rectal Exam|"Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.~Rectal Exam"
11359809|NCT02868892|BG000|Baseline|Pemetrexed|"Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.~Pemetrexed: Pemetrexed 500 mg/m2"
11359810|NCT02868892|FG000|Participant Flow|Pemetrexed|"Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.~Pemetrexed: Pemetrexed 500 mg/m2"
11359811|NCT02868892|OG000|Outcome|Pemetrexed|"Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.~Pemetrexed: Pemetrexed 500 mg/m2"
11359812|NCT02868892|EG000|Reported Event|Pemetrexed|"Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.~Pemetrexed: Pemetrexed 500 mg/m2"
10962063|NCT00864539|FG003|Participant Flow|Plain Juice|subjects receiving plain orange juice
11187348|NCT02105987|FG003|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch|Participants who completed early switch phase and maintained viral suppression (<50 Copies per milliliter [c/mL]) were switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
11187349|NCT02105987|FG004|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
11187350|NCT02105987|FG005|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
11187351|NCT02105987|OG000|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
11187352|NCT02105987|OG001|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
11187353|NCT02105987|EG000|Reported Event|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
11187354|NCT02105987|EG001|Reported Event|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
11187355|NCT02106065|BG000|Baseline|ESBR-i|"Education and Skill-Building Rehabilitation (in-clinic)~Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS."
11187356|NCT02106065|BG001|Baseline|ESBR-v|"Education and Skill-Building Rehabilitation (over video telehealth)~Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS."
11187357|NCT02106065|BG002|Baseline|Usual Care|"Usual Care plus supplemental paper education materials~Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia."
11187358|NCT02106065|BG003|Baseline|Total|Total of all reporting groups
11187359|NCT02106065|FG000|Participant Flow|ESBR-i|"Education and Skill-Building Rehabilitation (in-clinic)~Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS."
11187360|NCT02106065|FG001|Participant Flow|ESBR-v|"Education and Skill-Building Rehabilitation (over video telehealth)~Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS."
11187361|NCT02106065|FG002|Participant Flow|Usual Care|"Usual Care plus supplemental paper education materials~Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia."
11187362|NCT02106065|OG000|Outcome|ESBR-i|"Education and Skill-Building Rehabilitation (in-clinic)~Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS."
11187363|NCT02106065|OG001|Outcome|ESBR-v|"Education and Skill-Building Rehabilitation (over video telehealth)~Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS."
11187364|NCT02106065|OG002|Outcome|Usual Care|"Usual Care plus supplemental paper education materials~Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia."
10962064|NCT00864539|FG004|Participant Flow|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
10962065|NCT00864539|FG005|Participant Flow|Placebo|Subjects receiving daily placebo containing 1 g starch
10962066|NCT00864539|OG000|Outcome|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
10962067|NCT00864539|OG001|Outcome|Plain Milk|daily intake of 200 mL plain milk
10962068|NCT00864539|OG002|Outcome|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
11187365|NCT02106065|EG000|Reported Event|ESBR-i|"Education and Skill-Building Rehabilitation (in-clinic)~Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS."
11187366|NCT02106065|EG001|Reported Event|ESBR-v|"Education and Skill-Building Rehabilitation (over video telehealth)~Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS."
11187367|NCT02106065|EG002|Reported Event|Usual Care|"Usual Care plus supplemental paper education materials~Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia."
11187368|NCT02106156|BG000|Baseline|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
11187369|NCT02106156|BG001|Baseline|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
11187370|NCT02106156|BG002|Baseline|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
11187371|NCT02106156|BG003|Baseline|Total|Total of all reporting groups
11187372|NCT02106156|FG000|Participant Flow|Main Analysis Set|Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC).
11187373|NCT02106156|FG001|Participant Flow|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with hepatitis C virus (HCV) treatment as indicated.
11187374|NCT02106156|FG002|Participant Flow|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
11187375|NCT02106156|OG000|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
11187376|NCT02106156|OG001|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
11187377|NCT02106156|EG000|Reported Event|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
11187378|NCT02106156|EG001|Reported Event|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated.
11187379|NCT02106156|EG002|Reported Event|Elastography Analysis Set: Untreated|Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
11187380|NCT02106325|BG000|Baseline|Ketamine|"IV Ketamine .25mg/kg~Ketamine: IV of Ketamine (.25mg/kg)"
11187381|NCT02106325|BG001|Baseline|Diphenhydramine|"25mg Diphenhydramine~Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department"
11187382|NCT02106325|BG002|Baseline|Total|Total of all reporting groups
11187383|NCT02106325|FG000|Participant Flow|Ketamine|"IV Ketamine .25mg/kg~Ketamine: IV of Ketamine (.25mg/kg)"
11187384|NCT02106325|FG001|Participant Flow|Diphenhydramine|"25mg Diphenhydramine~Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department"
11187385|NCT02106325|OG000|Outcome|Ketamine|"IV Ketamine .25mg/kg~Ketamine: IV of Ketamine (.25mg/kg)"
11187386|NCT02106325|OG001|Outcome|Diphenhydramine|"25mg Diphenhydramine~Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department"
11187387|NCT02106325|EG000|Reported Event|Ketamine|"IV Ketamine .25mg/kg~Ketamine: IV of Ketamine (.25mg/kg)"
11187388|NCT02106325|EG001|Reported Event|Diphenhydramine|"25mg Diphenhydramine~Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department"
11187389|NCT02106351|BG000|Baseline|Dysport 2 U/kg|Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
11187390|NCT02106351|BG001|Baseline|Dysport 8 U/kg|Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
11187391|NCT02106351|BG002|Baseline|Dysport 16 U/kg|Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
11187392|NCT02106351|BG003|Baseline|Total|Total of all reporting groups
11187393|NCT02106351|FG000|Participant Flow|Dysport 2 U/kg|Subjects were randomised to receive Dysport 2 Units per kg (U/kg) by intramuscular (IM) injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4). Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
11187394|NCT02106351|FG001|Participant Flow|Dysport 8 U/kg|Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U. Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
11187395|NCT02106351|FG002|Participant Flow|Dysport 16 U/kg|Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U. Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
11187396|NCT02106351|OG000|Outcome|Dysport 2 U/kg|Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
11187397|NCT02106351|OG001|Outcome|Dysport 8 U/kg|Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
11187398|NCT02106351|OG002|Outcome|Dysport 16 U/kg|Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
11187399|NCT02106351|EG000|Reported Event|TC1: Dysport 2 U/kg|Subjects randomised to Dysport 2 U/kg in TC 1.
11187400|NCT02106351|EG001|Reported Event|TC 1: Dysport 8 U/kg|Subjects randomised to Dysport 8 U/kg in TC 1.
11187401|NCT02106351|EG002|Reported Event|TC 1: Dysport 16 U/kg|Subjects randomised to Dysport 16 U/kg in TC 1.
11187402|NCT02106351|EG003|Reported Event|TC 2: Dysport 8 U/kg|Subjects who received Dysport 8 U/kg in TC 2.
11187403|NCT02106351|EG004|Reported Event|TC 2: Dysport 16 U/kg|Subjects who received Dysport 16 U/kg in TC 2.
11187404|NCT02106351|EG005|Reported Event|TC 3: Dysport 8 U/kg|Subjects who received Dysport 8 U/kg in TC 3.
11187405|NCT02106351|EG006|Reported Event|TC 3: Dysport 16 U/kg|Subjects who received Dysport 16 U/kg in TC 3.
11187406|NCT02106351|EG007|Reported Event|TC 4: Dysport 8 U/kg|Subjects who received Dysport 8 U/kg in TC 4.
11187407|NCT02106351|EG008|Reported Event|TC 4: Dysport 16 U/kg|Subjects who received Dysport 16 U/kg in TC 4.
11187408|NCT02106390|BG000|Baseline|rMenB+ACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age.
11187409|NCT02106390|BG001|Baseline|rMenB Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.
11187410|NCT02106390|BG002|Baseline|MenACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
11187411|NCT02106390|BG003|Baseline|Total|Total of all reporting groups
11187412|NCT02106390|FG000|Participant Flow|rMenB+ACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age.
11187413|NCT02106390|FG001|Participant Flow|rMenB Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.
11187414|NCT02106390|FG002|Participant Flow|MenACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
11187415|NCT02106390|OG000|Outcome|rMenB+ACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age
11187416|NCT02106390|OG001|Outcome|rMenB Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.
11187417|NCT02106390|OG000|Outcome|rMenB+ACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age.
11187418|NCT02106390|OG001|Outcome|MenACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
11187419|NCT02106390|OG001|Outcome|MenACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.
11187420|NCT02106390|OG002|Outcome|MenACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
11187421|NCT02106390|EG000|Reported Event|rMenB+ACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age.
11187422|NCT02106390|EG001|Reported Event|rMenB Group|Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age
11187423|NCT02106390|EG002|Reported Event|MenACWY Group|Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
11187424|NCT02106403|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
11187425|NCT02106403|FG000|Participant Flow|Sequence 1|Prototype disinfectant spray was sprayed twice on first wound, followed by Reference product twice sprayed on the second wound and subsequently Negative control was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
11238591|NCT02464657|OG000|Outcome|Ph 1 - Nivolumab (1mg) + Idarubicin + Cytarabine|"Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238592|NCT02464657|OG001|Outcome|Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine|"Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238593|NCT02464657|OG000|Outcome|Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine|"Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238594|NCT02464657|OG000|Outcome|Ph 2 - Nivolumab (3mg) + Idarubicin + Cytarabine|"Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238595|NCT02464657|EG000|Reported Event|Ph 1 Nivolumab (1mg) + Idarubicin + Cytarabine|"Phase I dose of Nivolumab 1 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11240792|NCT02481934|FG000|Participant Flow|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
11240793|NCT02481934|OG000|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
11359813|NCT02865083|BG000|Baseline|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
11359814|NCT02865083|BG001|Baseline|Standard|Patients will receive use of the standard of care option which is the montgomery straps
11359815|NCT02865083|BG002|Baseline|Total|Total of all reporting groups
11359816|NCT02865083|FG000|Participant Flow|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
11359817|NCT02865083|FG001|Participant Flow|Standard|Patients will receive use of the standard of care option which is the montgomery straps
11359818|NCT02865083|OG000|Outcome|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
11359819|NCT02865083|OG001|Outcome|Standard|Patients will receive use of the standard of care option which is the montgomery straps
11359820|NCT02865083|EG000|Reported Event|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
11359821|NCT02865083|EG001|Reported Event|Standard|Patients will receive use of the standard of care option which is the montgomery straps
11359822|NCT02865122|BG000|Baseline|NTRA-9620-A|"NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day~NTRA-9620: Oral daily dose"
11359823|NCT02865122|BG001|Baseline|NTRA-9620-B|"NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day~NTRA-9620: Oral daily dose"
11359824|NCT02865122|BG002|Baseline|Placebo|"Placebo To be dosed orally for 24 weeks, 4 times/day~Placebo: Oral daily dose"
11359825|NCT02865122|BG003|Baseline|Total|Total of all reporting groups
11359826|NCT02865122|FG000|Participant Flow|NTRA-9620-A|"NTRA-9620 Dose 1: 2 IU/kg To be dosed orally for 24 weeks, 4 times/day~NTRA-9620: Oral daily dose"
11359827|NCT02865122|FG001|Participant Flow|NTRA-9620-B|"NTRA-9620 Dose 2 - 1 IU/kg To be dosed orally for 24 weeks, 4 times/day~NTRA-9620: Oral daily dose"
11359828|NCT02865122|FG002|Participant Flow|Placebo|"Placebo To be dosed orally for 24 weeks, 4 times/day~Placebo: Oral daily dose"
11359829|NCT02865122|OG000|Outcome|NTRA-9620-A|"NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day~NTRA-9620: Oral daily dose"
11359830|NCT02865122|OG001|Outcome|NTRA-9620-B|"NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day~NTRA-9620: Oral daily dose"
11359831|NCT02865122|OG002|Outcome|Placebo|"Placebo To be dosed orally for 24 weeks, 4 times/day~Placebo: Oral daily dose"
11359832|NCT02865122|EG000|Reported Event|NTRA-9620-A|"NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day~NTRA-9620: Oral daily dose"
11359833|NCT02865122|EG001|Reported Event|NTRA-9620-B|"NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day~NTRA-9620: Oral daily dose"
11359834|NCT02865122|EG002|Reported Event|Placebo|"Placebo To be dosed orally for 24 weeks, 4 times/day~Placebo: Oral daily dose"
11359835|NCT02865915|BG000|Baseline|Placebo Treatment Arm|Matching placebo tablet self-administered twice daily
11359836|NCT02865915|BG001|Baseline|MLE4901 Treatment Arm|Treatment with 1 tablet of MLE4901 self-administered twice daily [80% treated with dose of 40 mg twice daily]
11359837|NCT02865915|BG002|Baseline|Total|Total of all reporting groups
11359838|NCT02865915|FG000|Participant Flow|Placebo Treatment Arm|Treatment with 1 matching placebo tablet self-administered twice daily
11359839|NCT02865915|FG001|Participant Flow|MLE4901 Treatment Arm|Treatment with 1 tablet of MLE4901 self-administered twice daily [80% treated with dose of 40 mg twice daily]
11359840|NCT02865915|OG000|Outcome|Placebo Treatment Arm|Treatment with 1 matching placebo tablet self-administered twice daily
11359841|NCT02865915|OG001|Outcome|MLE4901 Treatment Arm|Treatment with 1 tablet of study drug self-administered twice daily (most dosed with 40 mg BID)
11359842|NCT02865915|EG000|Reported Event|Placebo Treatment Arm|Treatment with 1 matching placebo tablet self-administered twice daily
11359843|NCT02865915|EG001|Reported Event|MLE4901 Treatment Arm|Treatment with 1 tablet of MLE4901 self-administered twice daily [80% treated with dose of 40 mg twice daily]
11359844|NCT02855411|BG000|Baseline|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
11359845|NCT02855411|FG000|Participant Flow|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
11359846|NCT02855411|OG000|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
11359847|NCT02855411|EG000|Reported Event|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
11359848|NCT02828124|BG000|Baseline|BMS-986183 3 mg|Dose escalation in combination with Nivolumab
11359849|NCT02828124|BG001|Baseline|BMS-986183 9 mg|Dose escalation in combination with Nivolumab
11359850|NCT02828124|BG002|Baseline|BMS-986183 18 mg|Dose escalation in combination with Nivolumab
11359851|NCT02828124|BG003|Baseline|BMS-986183 36 mg|Dose escalation in combination with Nivolumab
11359852|NCT02828124|BG004|Baseline|Total|Total of all reporting groups
11359853|NCT02828124|FG000|Participant Flow|BMS-986183 3 mg|Dose escalation in combination with Nivolumab
11359854|NCT02828124|FG001|Participant Flow|BMS-986183 9 mg|Dose escalation in combination with Nivolumab
11359855|NCT02828124|FG002|Participant Flow|BMS-986183 18 mg|Dose escalation in combination with Nivolumab
11359856|NCT02828124|FG003|Participant Flow|BMS-986183 36 mg|Dose escalation in combination with Nivolumab
11359857|NCT02828124|OG000|Outcome|BMS-986183 3 mg|Dose escalation in combination with Nivolumab
11359858|NCT02828124|OG001|Outcome|BMS-986183 9 mg|Dose escalation in combination with Nivolumab
11359859|NCT02828124|OG002|Outcome|BMS-986183 18 mg|Dose escalation in combination with Nivolumab
11359860|NCT02828124|OG003|Outcome|BMS-986183 36 mg|Dose escalation in combination with Nivolumab
11359861|NCT02828124|EG000|Reported Event|BMS-986183 ESC 3 mg|Dose escalation in combination with Nivolumab
11359862|NCT02828124|EG001|Reported Event|BMS-986183 ESC 9 mg|Dose escalation in combination with Nivolumab
10962069|NCT00864539|OG003|Outcome|Plain Juice|subjects receiving plain orange juice
11359863|NCT02828124|EG002|Reported Event|BMS-986183 ESC 18 mg|Dose escalation in combination with Nivolumab
11359864|NCT02828124|EG003|Reported Event|BMS-986183 ESC 36 mg|Dose escalation in combination with Nivolumab
11359865|NCT02826551|BG000|Baseline|No Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.~Ice~Percocet~Knee Brace and Crutches"
11359866|NCT02826551|BG001|Baseline|Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.~Marcaine: Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.~Ice~Percocet~Knee Brace and Crutches"
11359867|NCT02826551|BG002|Baseline|Total|Total of all reporting groups
11359868|NCT02826551|FG000|Participant Flow|No Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.~Ice~Percocet~Knee Brace and Crutches"
11359869|NCT02826551|FG001|Participant Flow|Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.~Marcaine: Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.~Ice~Percocet~Knee Brace and Crutches"
11359870|NCT02826551|OG000|Outcome|No Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.~Ice~Percocet~Knee Brace and Crutches"
11359871|NCT02826551|OG001|Outcome|Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.~Marcaine: Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.~Ice~Percocet~Knee Brace and Crutches"
11359872|NCT02826551|EG000|Reported Event|No Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.~Ice~Percocet~Knee Brace and Crutches"
11359873|NCT02826551|EG001|Reported Event|Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.~Marcaine: Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.~Ice~Percocet~Knee Brace and Crutches"
11359874|NCT02825043|BG000|Baseline|High Flow Nasal Cannula Participants|"High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study.~High-Flow Nasal Cannula: This is a humidified oxygen delivery system."
11359875|NCT02825043|FG000|Participant Flow|High Flow Nasal Cannula Participants|"High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study.~High-Flow Nasal Cannula: This is a humidified oxygen delivery system."
11359876|NCT02825043|OG000|Outcome|High Flow Nasal Cannula Participants|"High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study.~High-Flow Nasal Cannula: This is a humidified oxygen delivery system."
11359877|NCT02825043|EG000|Reported Event|High Flow Nasal Cannula Participants|"High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study.~High-Flow Nasal Cannula: This is a humidified oxygen delivery system."
11359878|NCT02819804|BG000|Baseline|Treatment (Dasatinib, Nivolumab)|"Patients receive dasatinib PO QD on days 1-28 and nivolumab IV over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies"
11359879|NCT02819804|FG000|Participant Flow|Treatment (Dasatinib, Nivolumab)|"Patients receive dasatinib PO QD on days 1-28 and nivolumab IV over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies"
11359880|NCT02819804|OG000|Outcome|Treatment (Dasatinib, Nivolumab)|"Patients receive dasatinib PO QD on days 1-28 and nivolumab IV over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies"
11359881|NCT02819804|EG000|Reported Event|Treatment (Dasatinib, Nivolumab)|"Patients receive dasatinib PO QD on days 1-28 and nivolumab IV over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies"
11359882|NCT02809118|BG000|Baseline|Placebo|"Placebo gel for intratympanic use~Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia"
11359883|NCT02809118|BG001|Baseline|AM-111 0.4 mg/ml|"AM-111 gel for intratympanic use (0.4 mg/ml AM-111)~AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia"
11359884|NCT02809118|BG002|Baseline|AM-111 0.8 mg/ml|"AM-111 gel for intratympanic use (0.8 mg/ml AM-111)~AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia"
11359885|NCT02809118|BG003|Baseline|Total|Total of all reporting groups
11359886|NCT02809118|FG000|Participant Flow|Placebo|"Placebo gel for intratympanic use~Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia"
11359887|NCT02809118|FG001|Participant Flow|AM-111 0.4 mg/ml|"AM-111 gel for intratympanic use (0.4 mg/ml AM-111)~AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia"
11359888|NCT02809118|FG002|Participant Flow|AM-111 0.8 mg/ml|"AM-111 gel for intratympanic use (0.8 mg/ml AM-111)~AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia"
11359889|NCT02809118|OG000|Outcome|Placebo|"Placebo gel for intratympanic use~Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia"
11359890|NCT02809118|OG001|Outcome|AM-111 0.4 mg/ml|"AM-111 gel for intratympanic use (0.4 mg/ml AM-111)~AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia"
11359891|NCT02809118|OG002|Outcome|AM-111 0.8 mg/ml|"AM-111 gel for intratympanic use (0.8 mg/ml AM-111)~AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia"
11359892|NCT02809118|EG000|Reported Event|Placebo|"Placebo gel for intratympanic use~Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia"
11359893|NCT02809118|EG001|Reported Event|AM-111 0.4 mg/ml|"AM-111 gel for intratympanic use (0.4 mg/ml AM-111)~AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia"
11359894|NCT02809118|EG002|Reported Event|AM-111 0.8 mg/ml|"AM-111 gel for intratympanic use (0.8 mg/ml AM-111)~AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia"
11359895|NCT02818946|BG000|Baseline|Contrast-enhanced MRI for Evaluation of Nipple Discharge|"Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge.~MRI: Detection of cancer by MRI for pathologic nipple discharge"
11359896|NCT02818946|FG000|Participant Flow|Contrast-enhanced MRI for Evaluation of Nipple Discharge|"Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge.~MRI: Detection of cancer by MRI for pathologic nipple discharge"
11359897|NCT02818946|OG000|Outcome|Contrast-enhanced MRI for Evaluation of Nipple Discharge|"Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge.~MRI: Detection of cancer by MRI for pathologic nipple discharge"
11359898|NCT02818946|EG000|Reported Event|Contrast-enhanced MRI for Evaluation of Nipple Discharge|"Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge.~MRI: Detection of cancer by MRI for pathologic nipple discharge"
11359899|NCT02819908|BG000|Baseline|Imprimis Dropless|"TriMoxiVanc 0.2cc intravitreal one time~Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection"
11359900|NCT02819908|BG001|Baseline|Imprimis Less Drops|"Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks.~Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively"
11359901|NCT02819908|BG002|Baseline|Total|Total of all reporting groups
11359902|NCT02819908|FG000|Participant Flow|Imprimis Dropless|"TriMoxiVanc 0.2cc intravitreal one time~Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection"
11359903|NCT02819908|FG001|Participant Flow|Imprimis Less Drops|"Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks.~Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively"
11187426|NCT02106403|FG001|Participant Flow|Sequence 2|Prototype disinfectant spray was sprayed twice on first wound, followed by Negative control sprayed twice on the second wound and subsequently Reference product was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
11187427|NCT02106403|FG002|Participant Flow|Sequence 3|Reference product was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Negative control sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
11187428|NCT02106403|FG003|Participant Flow|Sequence 4|Reference product was sprayed twice on the first wound, followed by Negative control sprayed twice on the second wound and subsequently prototype disinfectant spray was twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
11187429|NCT02106403|FG004|Participant Flow|Sequence 5|Negative control was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Reference product sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
11187430|NCT02106403|FG005|Participant Flow|Sequence 6|Negative control was sprayed twice on the first wound, followed by Reference product sprayed twice on the second wound and Prototype Disinfectant Spray twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
11187431|NCT02106403|OG000|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
11187432|NCT02106403|OG001|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
11187433|NCT02106403|OG002|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
11187434|NCT02106403|OG000|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
11187435|NCT02106403|OG000|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound
11187436|NCT02106403|EG000|Reported Event|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
11187437|NCT02106403|EG001|Reported Event|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
11187438|NCT02106403|EG002|Reported Event|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
11187439|NCT02106442|BG000|Baseline|Sodium Risedronate 75 mg|75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
11187440|NCT02106442|FG000|Participant Flow|Sodium Risedronate 75 mg|75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
11359904|NCT02819908|OG000|Outcome|Imprimis Dropless|"TriMoxiVanc 0.2cc intravitreal one time~Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection~no Adverse events"
11359905|NCT02819908|OG001|Outcome|Imprimis Less Drops|"Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks.~Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively~No adverse events"
11187441|NCT02106442|OG000|Outcome|Sodium Risedronate 75 mg|75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
11187442|NCT02106442|EG000|Reported Event|Sodium Risedronate 75 mg|75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
11187443|NCT02106455|BG000|Baseline|Sodium Risedronate 17.5 mg|17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
11187444|NCT02106455|FG000|Participant Flow|Sodium Risedronate 17.5 mg|17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
11187445|NCT02106455|OG000|Outcome|Sodium Risedronate 17.5 mg|17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
11187446|NCT02106455|EG000|Reported Event|Sodium Risedronate 17.5 mg|17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
11187447|NCT02106494|BG000|Baseline|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187448|NCT02106494|BG001|Baseline|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187449|NCT02106494|BG002|Baseline|Total|Total of all reporting groups
11187450|NCT02106494|FG000|Participant Flow|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11359906|NCT02819908|OG000|Outcome|Imprimis Dropless|"TriMoxiVanc 0.2cc intravitreal one time~Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection"
11359907|NCT02819908|OG001|Outcome|Imprimis Less Drops|"Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks.~Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively"
11359908|NCT02819908|EG000|Reported Event|Imprimis Dropless|"TriMoxiVanc 0.2cc intravitreal one time~Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection~no Adverse events"
11359909|NCT02819908|EG001|Reported Event|Imprimis Less Drops|"Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks.~Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively~No adverse events"
11359910|NCT02808390|BG000|Baseline|80 mg BID|"GED-0507-34-Levo 80 mg BID for 8 Weeks~GED-0507-34-Levo 80 mg: GED-0507-34-Levo 80 mg BID for 8 Weeks"
11359911|NCT02808390|BG001|Baseline|160 mg BID|"GED-0507-34-Levo 160 mg BID for 8 Weeks~GED-0507-34-Levo 160 mg: GED-0507-34-Levo 160 mg BID for 8 Weeks"
11359912|NCT02808390|BG002|Baseline|Placebo|"Placebo BID for 8 Weeks~Placebo: Placebo BID for 8 Weeks"
11359913|NCT02808390|BG003|Baseline|Total|Total of all reporting groups
11359914|NCT02808390|FG000|Participant Flow|80 mg BID|"GED-0507-34-Levo 80 mg BID for 8 Weeks~GED-0507-34-Levo 80 mg: GED-0507-34-Levo 80 mg BID for 8 Weeks"
11359915|NCT02808390|FG001|Participant Flow|160 mg BID|"GED-0507-34-Levo 160 mg BID for 8 Weeks~GED-0507-34-Levo 160 mg: GED-0507-34-Levo 160 mg BID for 8 Weeks"
11359916|NCT02808390|FG002|Participant Flow|Placebo|"Placebo BID for 8 Weeks~Placebo: Placebo BID for 8 Weeks"
11359917|NCT02808390|OG000|Outcome|80 mg BID|80 mg BID treatment group
11359918|NCT02808390|OG001|Outcome|160 mg BID|160 mg BID treatment group
11359919|NCT02808390|OG002|Outcome|Placebo|Placebo treatment group
11359920|NCT02808390|EG000|Reported Event|80 mg BID|GED-0507-34-Levo 80 mg BID
11359921|NCT02808390|EG001|Reported Event|160 mg BID|GED-0507-34-Levo 160 mg BID
11359922|NCT02808390|EG002|Reported Event|Placebo|Placebo treatment
11359923|NCT02806960|BG000|Baseline|All Participants|A minimum dose of 3 mg NG was administered.
11359924|NCT02806960|FG000|Participant Flow|Sequence 1 (Treatment 1, 2, 3 and 4)|"The intranasal (IN) glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:~Period 1: Single 3 mg dose of Nasal glucagon (NG).~Period 2: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon 15 minutes later in the same nostril (for a total of 6 mg of glucagon).~Period 3: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).~Period 4: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon)."
11359925|NCT02806960|FG001|Participant Flow|Sequence 2 (Treatment 2, 3, 4 and 1)|"The Intranasal glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:~Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon).~Period 2: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).~Period 3: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).~Period 4: Single 3 mg dose of NG."
11359926|NCT02806960|FG002|Participant Flow|Sequence 3 (Treatment 3, 4, 1 and 2)|"The IN glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:~Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).~Period 2: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).~Period 3: Single 3 mg dose of NG.~Period 4: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon)."
11359927|NCT02806960|FG003|Participant Flow|Sequence 4 (Treatment 4, 1, 2 and 3)|"The IN glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:~Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).~Period 2: Single 3 mg dose of NG.~Period 3: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon).~Period 4: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon)."
11359928|NCT02806960|OG000|Outcome|Treatment 1|Single NG dose of 3 mg
11359929|NCT02806960|OG001|Outcome|Treatment 2|NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later
11359930|NCT02806960|OG002|Outcome|Treatment 3|NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later
11359931|NCT02806960|OG003|Outcome|Treatment 4|NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
11359932|NCT02806960|EG000|Reported Event|Treatment 1|Single NG dose of 3 mg.
11359933|NCT02806960|EG001|Reported Event|Treatment 2|NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
11359934|NCT02806960|EG002|Reported Event|Treatment 3|NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.
11359935|NCT02806960|EG003|Reported Event|Treatment 4|NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
11359936|NCT02815397|BG000|Baseline|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
11359937|NCT02815397|FG000|Participant Flow|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
11359938|NCT02815397|OG000|Outcome|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
11359939|NCT02815397|EG000|Reported Event|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
11359940|NCT02802592|BG000|Baseline|All Participants|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm~OR~250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
11359941|NCT02802592|FG000|Participant Flow|All Participants|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm~OR~250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
11359942|NCT02802592|OG000|Outcome|Epogen|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr~Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
11359943|NCT02802592|OG001|Outcome|Normal Saline|"250 ml normal saline infused over 1 hr~Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
11359944|NCT02802592|EG000|Reported Event|All Participants|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm~OR~250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
11359945|NCT02774148|BG000|Baseline|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
11359946|NCT02774148|BG001|Baseline|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
11359947|NCT02774148|BG002|Baseline|Total|Total of all reporting groups
11359948|NCT02774148|FG000|Participant Flow|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
11359949|NCT02774148|FG001|Participant Flow|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
11359950|NCT02774148|OG000|Outcome|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
11359951|NCT02774148|OG001|Outcome|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
11359952|NCT02774148|EG000|Reported Event|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
11359953|NCT02774148|EG001|Reported Event|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
11359954|NCT02773576|BG000|Baseline|2x360 mg Risperidone Implant|"2, 360 mg risperidone implants~Risperidone implant"
11359955|NCT02773576|BG001|Baseline|3x300 mg Risperidone Implant|"3, 300 mg risperidone implants~Risperidone implant"
11359956|NCT02773576|BG002|Baseline|Total|Total of all reporting groups
11359957|NCT02773576|FG000|Participant Flow|2x360 mg Risperidone Implant|"2, 360 mg risperidone implants~Risperidone implant"
11359958|NCT02773576|FG001|Participant Flow|3x300 mg Risperidone Implant|"3, 300 mg risperidone implants~Risperidone implant"
11359959|NCT02773576|OG000|Outcome|2x360 mg Risperidone Implant|"2, 360 mg risperidone implants~Risperidone implant"
11359960|NCT02773576|OG001|Outcome|3x300 mg Risperidone Implant|"3, 300 mg risperidone implants~Risperidone implant"
11359961|NCT02773576|EG000|Reported Event|2x360 mg Risperidone Implant|"2, 360 mg risperidone implants~Risperidone implant"
11359962|NCT02773576|EG001|Reported Event|3x300 mg Risperidone Implant|"3, 300 mg risperidone implants~Risperidone implant"
11359963|NCT02730793|BG000|Baseline|Standard Therapy|"Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day~Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)~Nasal Placebo: Placebo (nasal saline twice per day)"
11359964|NCT02730793|BG001|Baseline|Study Therapy|"Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day~Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)~Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)"
11359965|NCT02730793|BG002|Baseline|Total|Total of all reporting groups
11359966|NCT02730793|FG000|Participant Flow|Standard Therapy|"Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day~Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)~Nasal Placebo: Placebo (nasal saline twice per day)"
11359967|NCT02730793|FG001|Participant Flow|Study Therapy|"Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day~Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)~Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)"
11359968|NCT02730793|OG000|Outcome|Standard Therapy|"Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day~Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)~Nasal Placebo: Placebo (nasal saline twice per day)"
11359969|NCT02730793|OG001|Outcome|Study Therapy|"Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day~Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)~Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)"
11359970|NCT02730793|EG000|Reported Event|Standard Therapy|"Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day~Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)~Nasal Placebo: Placebo (nasal saline twice per day)"
11359971|NCT02730793|EG001|Reported Event|Study Therapy|"Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day~Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)~Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)"
11359972|NCT02744352|BG000|Baseline|Continuous IBP Block|"Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain~20ml bolus of 0.5% ropivicaine: Local anesthetic~0.2% of ropivacaine at 8 milliliter/hour: Local anesthetic"
11359973|NCT02744352|BG001|Baseline|Single Shot IBP Block|"Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain~20ml bolus of 0.5% ropivicaine: Local anesthetic"
11359974|NCT02744352|BG002|Baseline|Total|Total of all reporting groups
11359975|NCT02744352|FG000|Participant Flow|Continuous IBP Block|"Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain~20ml bolus of 0.5% ropivicaine: Local anesthetic~0.2% of ropivacaine at 8 milliliter/hour: Local anesthetic"
11359976|NCT02744352|FG001|Participant Flow|Single Shot IBP Block|"Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain~20ml bolus of 0.5% ropivicaine: Local anesthetic"
11359977|NCT02744352|OG000|Outcome|Continuous IBP Block|"Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain~20ml bolus of 0.5% ropivicaine: Local anesthetic~0.2% of ropivacaine at 8 milliliter/hour: Local anesthetic"
11359978|NCT02744352|OG001|Outcome|Single Shot IBP Block|"Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain~20ml bolus of 0.5% ropivicaine: Local anesthetic"
11359979|NCT02744352|EG000|Reported Event|Continuous IBP Block|"Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain~20ml bolus of 0.5% ropivicaine: Local anesthetic~0.2% of ropivacaine at 8 milliliter/hour: Local anesthetic"
11359980|NCT02744352|EG001|Reported Event|Single Shot IBP Block|"Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain~20ml bolus of 0.5% ropivicaine: Local anesthetic"
11359981|NCT02760602|BG000|Baseline|Solanezumab|Solanezumab given IV once every 4 weeks for up to 2 years.
11359982|NCT02760602|BG001|Baseline|Placebo|Placebo given IV once every 4 weeks for up to 2 years.
11359983|NCT02760602|BG002|Baseline|Total|Total of all reporting groups
11359984|NCT02760602|FG000|Participant Flow|Solanezumab|Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
11359985|NCT02760602|FG001|Participant Flow|Placebo|Placebo given IV once every 4 weeks for up to 2 years.
11359986|NCT02760602|OG000|Outcome|Solanezumab|Solanezumab given IV once every 4 weeks for up to 2 years.
11359987|NCT02760602|OG001|Outcome|Placebo|Placebo given IV once every 4 weeks for up to 2 years.
11359988|NCT02760602|EG000|Reported Event|Solanezumab|Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
11359989|NCT02760602|EG001|Reported Event|Placebo|Placebo given IV once every 4 weeks for up to 2 years.
11359990|NCT02757521|BG000|Baseline|Placebo|"50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)~Placebo: 50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)"
11359991|NCT02757521|BG001|Baseline|Nitrous Oxide|"50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)~Nitrous Oxide: 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)"
11359992|NCT02757521|BG002|Baseline|Total|Total of all reporting groups
11359993|NCT02757521|FG000|Participant Flow|Placebo|"50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)~Placebo: 50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)"
11359994|NCT02757521|FG001|Participant Flow|Nitrous Oxide|"50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)~Nitrous Oxide: 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)"
11359995|NCT02757521|OG000|Outcome|Placebo|"50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)~Placebo: 50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)"
11359996|NCT02757521|OG001|Outcome|Nitrous Oxide|"50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)~Nitrous Oxide: 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)"
11359997|NCT02757521|EG000|Reported Event|Placebo|"50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)~Placebo: 50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)"
11359998|NCT02757521|EG001|Reported Event|Nitrous Oxide|"50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)~Nitrous Oxide: 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)"
11359999|NCT02758132|BG000|Baseline|Alliance A031201|"Denosumab plus enzalutamide, abiraterone and prednisone~Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.~Enzalutamide: 160 mg enzalutamide by mouth daily~Abiraterone: 1000 mg abiraterone by mouth daily~Prednisone: 5 mg prednisone by mouth twice daily"
11360000|NCT02758132|BG001|Baseline|Standard of Care|"Denosumab plus enzalutamide alone~Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.~Enzalutamide: 160 mg enzalutamide by mouth daily"
11360001|NCT02758132|BG002|Baseline|Total|Total of all reporting groups
11360002|NCT02758132|FG000|Participant Flow|Alliance A031201|"Denosumab plus enzalutamide, abiraterone and prednisone~Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.~Enzalutamide: 160 mg enzalutamide by mouth daily~Abiraterone: 1000 mg abiraterone by mouth daily~Prednisone: 5 mg prednisone by mouth twice daily"
11360003|NCT02758132|FG001|Participant Flow|Standard of Care|"Denosumab plus enzalutamide alone~Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.~Enzalutamide: 160 mg enzalutamide by mouth daily"
11360004|NCT02758132|OG000|Outcome|Alliance A031201|"Denosumab plus enzalutamide, abiraterone and prednisone~Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.~Enzalutamide: 160 mg enzalutamide by mouth daily~Abiraterone: 1000 mg abiraterone by mouth daily~Prednisone: 5 mg prednisone by mouth twice daily"
11360005|NCT02758132|OG001|Outcome|Standard of Care|"Denosumab plus enzalutamide alone~Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.~Enzalutamide: 160 mg enzalutamide by mouth daily"
11360006|NCT02758132|EG000|Reported Event|Alliance A031201|"Denosumab plus enzalutamide, abiraterone and prednisone~Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.~Enzalutamide: 160 mg enzalutamide by mouth daily~Abiraterone: 1000 mg abiraterone by mouth daily~Prednisone: 5 mg prednisone by mouth twice daily"
11360007|NCT02758132|EG001|Reported Event|Standard of Care|"Denosumab plus enzalutamide alone~Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.~Enzalutamide: 160 mg enzalutamide by mouth daily"
11360008|NCT02757547|BG000|Baseline|TMS - Placebo Arm Followed by Active Arm|"A placebo TMS coil is used for the Placebo Arm:~Transcranial magnetic stimulation - Placebo Arm: Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation.~An active TMS coil is used for the Active Arm:~Transcranial magnetic stimulation - Active Arm: Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total."
11360009|NCT02757547|FG000|Participant Flow|TMS Placebo Arm Followed by TMS Active Arm|"A placebo TMS coil is used for the Placebo Arm~Transcranial magnetic stimulation - Placebo Arm: Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation.~TMS Active Arm:~An active TMS coil is used. Transcranial magnetic stimulation - Active Arm: Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total."
11360010|NCT02757547|OG000|Outcome|TMS - Placebo Arm Followed by Active Arm|"A placebo TMS coil is used.~Transcranial magnetic stimulation - Placebo Arm: Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation."
11360011|NCT02757547|EG000|Reported Event|Transcranial Magnetic Stimulation - Placebo Arm|"A placebo TMS coil is used.~Transcranial magnetic stimulation - Placebo Arm: Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation."
11360012|NCT02757547|EG001|Reported Event|Transcranial Magnetic Stimulation - Active Arm|"An active TMS coil is used.~Transcranial magnetic stimulation - Active Arm: Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total."
10962070|NCT00864539|OG004|Outcome|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
10962071|NCT00864539|OG005|Outcome|Placebo|Subjects receiving daily placebo containing 1 g starch
11360013|NCT02757053|BG000|Baseline|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
11360014|NCT02757053|BG001|Baseline|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
11360015|NCT02757053|BG002|Baseline|Total|Total of all reporting groups
11360016|NCT02757053|FG000|Participant Flow|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
11360017|NCT02757053|FG001|Participant Flow|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
11360018|NCT02757053|OG000|Outcome|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
11360019|NCT02757053|OG001|Outcome|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
11360020|NCT02757053|EG000|Reported Event|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
11360021|NCT02757053|EG001|Reported Event|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
11360022|NCT02734940|BG000|Baseline|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 - 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
11360023|NCT02734940|BG001|Baseline|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
11360024|NCT02734940|BG002|Baseline|Total|Total of all reporting groups
11360025|NCT02734940|FG000|Participant Flow|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 - 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
11360026|NCT02734940|FG001|Participant Flow|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
11360027|NCT02734940|OG000|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 - 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
11360028|NCT02734940|OG001|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
11360029|NCT02734940|EG000|Reported Event|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 - 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
10962072|NCT00864539|EG000|Reported Event|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
10962073|NCT00864539|EG001|Reported Event|Plain Milk|daily intake of 200 mL plain milk
11187451|NCT02106494|FG001|Participant Flow|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187452|NCT02106494|OG000|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187453|NCT02106494|OG001|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187454|NCT02106494|OG000|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187455|NCT02106494|OG001|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187456|NCT02106494|EG000|Reported Event|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187457|NCT02106494|EG001|Reported Event|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
11187458|NCT02106728|BG000|Baseline|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
11187459|NCT02106728|BG001|Baseline|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
11187460|NCT02106728|BG002|Baseline|Total|Total of all reporting groups
11187461|NCT02106728|FG000|Participant Flow|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
11187462|NCT02106728|FG001|Participant Flow|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
11187463|NCT02106728|OG000|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
11187464|NCT02106728|OG001|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
11341804|NCT03688620|OG003|Outcome|Total Group|Volunteered male and female subjects from Vaccinated_AlphaRix Tetra Group, Vaccinated_Influsplit Tetra Group and Vaccinated_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
11187465|NCT02106728|OG000|Outcome|Multi-Family Therapy (PRE)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
11187466|NCT02106728|OG001|Outcome|Supportive Family Therapy (PRE)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
11187467|NCT02106728|OG002|Outcome|Multi-Family Therapy (POST)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
11187468|NCT02106728|OG003|Outcome|Supportive Family Therapy (POST)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
11187469|NCT02106728|OG004|Outcome|Multi-Family Therapy (8WEEKS)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
11187470|NCT02106728|OG005|Outcome|Supportive Family Therapy (Approximately 10 WEEKS)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
11187471|NCT02106728|EG000|Reported Event|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
11187472|NCT02106728|EG001|Reported Event|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
11187473|NCT02106832|BG000|Baseline|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
11187474|NCT02106832|BG001|Baseline|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11187475|NCT02106832|BG002|Baseline|Placebo 28 Days on/Off (Placebo 28)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
11187476|NCT02106832|BG003|Baseline|Placebo 14 Days on/Off (Placebo 14)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
11187477|NCT02106832|BG004|Baseline|Total|Total of all reporting groups
11187478|NCT02106832|FG000|Participant Flow|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
11187479|NCT02106832|FG001|Participant Flow|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11187480|NCT02106832|FG002|Participant Flow|Placebo 28 Days on/Off (Placebo 28)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
11187481|NCT02106832|FG003|Participant Flow|Placebo 14 Days on/Off (Placebo 14)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
11187482|NCT02106832|OG000|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
11187483|NCT02106832|OG001|Outcome|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
11360030|NCT02734940|EG001|Reported Event|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
11360031|NCT02749617|BG000|Baseline|Apixaban|"apixaban 2.5 mg PO BID~apixaban: 2.5 mg PO BID"
11360032|NCT02749617|FG000|Participant Flow|Apixaban|"apixaban 2.5 mg PO BID~apixaban: 2.5 mg PO BID"
11360033|NCT02749617|OG000|Outcome|Apixaban|"apixaban 2.5 mg PO BID~apixaban: 2.5 mg PO BID"
11360034|NCT02749617|EG000|Reported Event|Apixaban|"apixaban 2.5 mg PO BID~apixaban: 2.5 mg PO BID"
11360035|NCT02749227|BG000|Baseline|Pasireotide LAR Therapy|"Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed.~Pasireotide LAR: Pasireotide LAR (SIGNIFOR® LAR) is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. It is a long acting release injectable suspension for intramuscular use.~The starting dose is Pasireotide LAR 40 mg/month intramuscular (IM), this will be increased to 60 mg/month at 6 months if a fall in POMC levels and/or tumor shrinkage are not attained."
11360036|NCT02749227|FG000|Participant Flow|Pasireotide LAR Therapy|"Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed.~Pasireotide LAR: Pasireotide LAR (SIGNIFOR® LAR) is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. It is a long acting release injectable suspension for intramuscular use.~The starting dose is Pasireotide LAR 40 mg/month intramuscular (IM), this will be increased to 60 mg/month at 6 months if a fall in POMC levels and/or tumor shrinkage are not attained."
11360037|NCT02749227|OG000|Outcome|Pasireotide LAR Therapy|"Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed.~Pasireotide LAR: Pasireotide LAR (SIGNIFOR® LAR) is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. It is a long acting release injectable suspension for intramuscular use.~The starting dose is Pasireotide LAR 40 mg/month intramuscular (IM), this will be increased to 60 mg/month at 6 months if a fall in POMC levels and/or tumor shrinkage are not attained."
11360038|NCT02749227|EG000|Reported Event|Pasireotide LAR Therapy|"Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed.~Pasireotide LAR: Pasireotide LAR (SIGNIFOR® LAR) is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. It is a long acting release injectable suspension for intramuscular use.~The starting dose is Pasireotide LAR 40 mg/month intramuscular (IM), this will be increased to 60 mg/month at 6 months if a fall in POMC levels and/or tumor shrinkage are not attained."
11360039|NCT02745210|BG000|Baseline|Traumatic Brain Injury|Participants with TBI undergoing 13C Magnetic resonance (MR) spectroscopy.
11360040|NCT02745210|BG001|Baseline|Control|control (non-injured) participants undergoing 13C Magnetic resonance (MR) spectroscopy.
11360041|NCT02745210|BG002|Baseline|Total|Total of all reporting groups
11360042|NCT02745210|FG000|Participant Flow|Traumatic Brain Injury|Participants with TBI undergoing 13C Magnetic resonance (MR) spectroscopy.
11360043|NCT02745210|FG001|Participant Flow|Control|control (non-injured) participants undergoing 13C Magnetic resonance (MR) spectroscopy.
11360044|NCT02745210|OG000|Outcome|Experimental|"13C Magnetic resonance (MR) spectroscopy.~13C magnetic resonance spectroscopy: acquisition of 13C MR spectroscopy in the brain"
11360045|NCT02745210|EG000|Reported Event|Experimental|13C Magnetic resonance (MR) spectroscopy.
11360046|NCT02725671|BG000|Baseline|Study Group|Single study group. All patients are planned to undergo both tests, CGM and CT angiography.
10962074|NCT00864539|EG002|Reported Event|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
11360047|NCT02725671|FG000|Participant Flow|Study Group|Single study group. All patients are planned to undergo both tests, Cardiogoniometry (CGM) and CT angiography.
11360048|NCT02725671|OG000|Outcome|Study Group|Single study group. All patients are planned to undergo both tests, CGM and CT angiography.
11360049|NCT02725671|OG000|Outcome|Study Group|Single study group. All patients are planned to undergo both tests, Cardiogoniometry (CGM) and CT angiography.
11360050|NCT02725671|OG000|Outcome|Cardiogoniometry and ECG Assessment|"The same patient will undergo both advanced ECG assessment using cardiogoniometry and standard ECG~Explorer: ECG device which records comprehensive voltage potential data in the myocardium"
11360051|NCT02725671|EG000|Reported Event|Cardiogoniometry and ECG Assessment|"The same patient will undergo both advanced ECG assessment using cardiogoniometry and standard ECG~Explorer: ECG device which records comprehensive voltage potential data in the myocardium"
11360052|NCT02746263|BG000|Baseline|IV Acetaminophen/Morphine|"IV acetaminophen 1000 mg every 6 hours over 18 hours~IV acetaminophen~Morphine: Patient controlled analgesia"
11360053|NCT02746263|BG001|Baseline|Oral Acetaminophen/Morphine|"Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours~Oral acetaminophen~Morphine: Patient controlled analgesia"
11360054|NCT02746263|BG002|Baseline|Total|Total of all reporting groups
11360055|NCT02746263|FG000|Participant Flow|IV Acetaminophen/Morphine|"IV acetaminophen 1000 mg every 6 hours over 18 hours~IV acetaminophen~Morphine: Patient controlled analgesia"
11360056|NCT02746263|FG001|Participant Flow|Oral Acetaminophen/Morphine|"Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours~Oral acetaminophen~Morphine: Patient controlled analgesia"
11360057|NCT02746263|OG000|Outcome|IV Acetaminophen/Morphine|"IV acetaminophen 1000 mg every 6 hours over 18 hours~IV acetaminophen~Morphine: Patient controlled analgesia"
11360058|NCT02746263|OG001|Outcome|Oral Acetaminophen/Morphine|"Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours~Oral acetaminophen~Morphine: Patient controlled analgesia"
11360059|NCT02746263|EG000|Reported Event|IV Acetaminophen/Morphine|"IV acetaminophen 1000 mg every 6 hours over 18 hours~IV acetaminophen~Morphine: Patient controlled analgesia"
11360060|NCT02746263|EG001|Reported Event|Oral Acetaminophen/Morphine|"Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours~Oral acetaminophen~Morphine: Patient controlled analgesia"
11360061|NCT02721277|BG000|Baseline|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
11360062|NCT02721277|FG000|Participant Flow|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
11360063|NCT02721277|OG000|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
11360064|NCT02721277|EG000|Reported Event|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
11360065|NCT02732327|BG000|Baseline|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
11360066|NCT02732327|BG001|Baseline|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
11360067|NCT02732327|BG002|Baseline|Total|Total of all reporting groups
11360068|NCT02732327|FG000|Participant Flow|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
11360069|NCT02732327|FG001|Participant Flow|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
11360070|NCT02732327|OG000|Outcome|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
10962075|NCT00864539|EG003|Reported Event|Plain Juice|subjects receiving plain orange juice
11187484|NCT02106832|OG001|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11187485|NCT02106832|OG002|Outcome|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
11187486|NCT02106832|OG002|Outcome|Placebo 28 Days on/Off (Placebo 28)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
11187487|NCT02106832|OG003|Outcome|Placebo 14 Days on/Off (Placebo 14)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
10962076|NCT00864539|EG004|Reported Event|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
10962077|NCT00864539|EG005|Reported Event|Placebo|Subjects receiving daily placebo containing 1 g starch
11187488|NCT02106832|OG000|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11187489|NCT02106832|EG000|Reported Event|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
11187490|NCT02106832|EG001|Reported Event|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
11187491|NCT02106832|EG002|Reported Event|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
11187492|NCT02106884|BG000|Baseline|Arm A (Nab-Paclitaxel + Gemcitabine)|"Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.~Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed."
11187493|NCT02106884|BG001|Baseline|Arm B (Gemcitabine Monotherapy)|"Patients were randomised to receive gemcitabine monotherapy.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination."
11187494|NCT02106884|BG002|Baseline|Total|Total of all reporting groups
11187495|NCT02106884|FG000|Participant Flow|Arm A (Nab-Paclitaxel + Gemcitabine)|"Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.~Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed."
11187496|NCT02106884|FG001|Participant Flow|Arm B (Gemcitabine)|"Patients were randomised to receive gemcitabine monotherapy.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination."
11187497|NCT02106884|OG000|Outcome|Arm A (Nab-Paclitaxel + Gemcitabine)|"Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.~Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed."
11240794|NCT02481934|EG000|Reported Event|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
10962078|NCT00864682|BG000|Baseline|Control Arm|saline pretreatment, saline plus propofol admixture
11187498|NCT02106884|OG001|Outcome|Arm B (Gemcitabine)|"Patients were randomised to receive gemcitabine monotherapy.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37)."
11187499|NCT02106884|OG000|Outcome|Arm A (Nab-Paclitaxel +Gemcitabine)|"Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.~Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed."
11187500|NCT02106884|OG000|Outcome|Arm A (Nab-Paclitaxel + Gemcitabine)|"Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.~Nab-paclitaxel) - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed."
11187501|NCT02106884|OG001|Outcome|Arm B (Gemcitabine)|"Patients were randomised to receive gemcitabine monotherapy.~Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination."
11187502|NCT02106884|EG000|Reported Event|Arm A (Nab-Paclitaxel + Gemcitabine)|Nab-paclitaxel - IV - 125 mg/m2 - 3xq4wks Gemcitabine - IV - 1000 mg/m2 - 3xq4wks
11187503|NCT02106884|EG001|Reported Event|Arm B (Gemcitabine)|Gemcitabine - IV - 1000 mg/m2 - 3xq4wks
11187504|NCT02106910|BG000|Baseline|Participants With Barrett's and no History of Ablation|"Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation.~Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11187505|NCT02106910|BG001|Baseline|Participants With Barrett's After Ablation|"Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET).~Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11187506|NCT02106910|BG002|Baseline|Total|Total of all reporting groups
11187507|NCT02106910|FG000|Participant Flow|Participants With Barrett's and no History of Ablation|"Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation.~Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11187508|NCT02106910|FG001|Participant Flow|Participants With Barrett's After Ablation|"Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET).~Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11187509|NCT02106910|OG000|Outcome|Participants With Barrett's and no History of Ablation|"Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation.~Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11187510|NCT02106910|OG001|Outcome|Participants With Barrett's After Ablation|"Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET).~Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.~Period Title: Overall Study"
11187511|NCT02106910|OG001|Outcome|Participants With Barrett's After Ablation|"Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET).~Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus."
11187512|NCT02106910|EG000|Reported Event|Participants With Barrett's and no History of Ablation|Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
11187513|NCT02106910|EG001|Reported Event|Participants With Barrett's After Ablation|Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
11240795|NCT02481947|BG000|Baseline|BLI400 Laxative|"BLI400 Laxative~BLI400 Laxative: Oral laxative"
11240796|NCT02481947|BG001|Baseline|Lubiprostone|"Lubiprostone~Lubiprostone: Oral laxative"
11187514|NCT02106923|BG000|Baseline|1000mg, Fasted|Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg metformin (Met) XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
11187515|NCT02106923|BG001|Baseline|1000mg, Fed|Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal
11360071|NCT02732327|OG001|Outcome|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
11360072|NCT02732327|EG000|Reported Event|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
11360073|NCT02732327|EG001|Reported Event|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
11360074|NCT02726399|BG000|Baseline|Ramucirumab With Trastuzumab and Capecitabine/Cisplatin|"This will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days.~Ramucirumab: Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days~Trastuzumab: Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days~Capecitabine: Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period~Cisplatin: Cisplatin 80mg/m2 administered as an IV infusion every 21 days"
11360075|NCT02726399|FG000|Participant Flow|Ramucirumab With Trastuzumab and Capecitabine/Cisplatin|"This will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days.~Ramucirumab: Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days~Trastuzumab: Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days~Capecitabine: Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period~Cisplatin: Cisplatin 80mg/m2 administered as an IV infusion every 21 days"
11360076|NCT02726399|OG000|Outcome|Ramucirumab With Trastuzumab and Capecitabine/Cisplatin|"This will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days.~Ramucirumab: Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days~Trastuzumab: Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days~Capecitabine: Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period~Cisplatin: Cisplatin 80mg/m2 administered as an IV infusion every 21 days"
11360077|NCT02726399|EG000|Reported Event|Ramucirumab With Trastuzumab and Capecitabine/Cisplatin|"This will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days.~Ramucirumab: Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days~Trastuzumab: Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days~Capecitabine: Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period~Cisplatin: Cisplatin 80mg/m2 administered as an IV infusion every 21 days"
11360078|NCT02720510|BG000|Baseline|Arm 1 - RVD + Pan|Revlimid, Velcade, dexamethasone and Farydak
11360079|NCT02720510|BG001|Baseline|Arm 2 - RVD|Revlimid, Velcade and Dexamethasone
11360080|NCT02720510|BG002|Baseline|Total|Total of all reporting groups
11360081|NCT02720510|FG000|Participant Flow|Arm 1 - RVD + Pan|Revlimid, Velcade, dexamethasone and Farydak
11360082|NCT02720510|FG001|Participant Flow|Arm 2 - RVD|Revlimid, Velcade and Dexamethasone
11360083|NCT02720510|OG000|Outcome|Arm 1 - RVD + Pan|Revlimid, Velcade, dexamethasone and Farydak
11360084|NCT02720510|OG001|Outcome|Arm 2 - RVD|Revlimid, Velcade and Dexamethasone
11360085|NCT02720510|EG000|Reported Event|Arm 1- RVD+PAN|Revlimid, Velcade, dexamethasone and Farydak
11360086|NCT02720510|EG001|Reported Event|Arm 2 - RVD|Revlimid, Velcade and Dexamethasone
11376231|NCT01238211|BG000|Baseline|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
11360087|NCT02715765|BG000|Baseline|Sham|"The sham procedure involves only 40 sec direct current stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec.~Transcranial Sham Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. The sham procedure involves only 40 sec stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction"
11360088|NCT02715765|BG001|Baseline|Active tDCS|"Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). The current is held constant for 20 min. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.~Transcranial Direct Current Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA."
11360089|NCT02715765|BG002|Baseline|Active tRNS|"Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). Once at 2mA, an alternating current of 2mA with a 0mA offset is applied at random frequencies over a range of 0.1 to 100 Hz. This is performed for 20 minutes. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.~Transcranial Random Noise Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA."
11360090|NCT02715765|BG003|Baseline|Total|Total of all reporting groups
11360091|NCT02715765|FG000|Participant Flow|Sham|"The sham procedure involves only 40 sec direct current stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec.~Transcranial Sham Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. The sham procedure involves only 40 sec stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction"
11360092|NCT02715765|FG001|Participant Flow|Active tDCS|"Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). The current is held constant for 20 min. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.~Transcranial Direct Current Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA."
11360093|NCT02715765|FG002|Participant Flow|Active tRNS|"Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). Once at 2mA, an alternating current of 2mA with a 0mA offset is applied at random frequencies over a range of 0.1 to 100 Hz. This is performed for 20 minutes. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.~Transcranial Random Noise Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA."
11360094|NCT02715765|OG000|Outcome|Sham|"The sham procedure involves only 40 sec direct current stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec.~Transcranial Sham Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. The sham procedure involves only 40 sec stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction"
11360095|NCT02715765|OG001|Outcome|Active tDCS|"Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). The current is held constant for 20 min. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.~Transcranial Direct Current Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA."
11360096|NCT02715765|OG002|Outcome|Active tRNS|"Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). Once at 2mA, an alternating current of 2mA with a 0mA offset is applied at random frequencies over a range of 0.1 to 100 Hz. This is performed for 20 minutes. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.~Transcranial Random Noise Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA."
11360097|NCT02715765|EG000|Reported Event|Sham|"The sham procedure involves only 40 sec direct current stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec.~Transcranial Sham Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. The sham procedure involves only 40 sec stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction"
10962079|NCT00864682|BG001|Baseline|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
10962080|NCT00864682|BG002|Baseline|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
10962081|NCT00864682|BG003|Baseline|Total|Total of all reporting groups
11238596|NCT02464657|EG001|Reported Event|Ph 1 Nivolumab (3mg) + Idarubicin + Cytarabine|"Phase I dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238597|NCT02464657|EG002|Reported Event|Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine|"Phase II dose of Nivolumab 3 mg/kg by vein on Day 24 of a 28 day cycle. Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Phase I and Phase II dose of Solumedrol 50 mg or Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Nivolumab: Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I.~Idarubicin: Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.~Cytarabine: Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.~Solu-medrol: Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.~Dexamethasone: Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle."
11238598|NCT02464917|BG000|Baseline|Supplemental Oxygen|"Subjects in this arm will receive 10L/min via simple facemask~Device: simple facemask to administer supplemental oxygen"
11238599|NCT02464917|BG001|Baseline|Room Air|This control arm will receive no supplemental oxygen
11238600|NCT02464917|BG002|Baseline|Total|Total of all reporting groups
11238601|NCT02464917|FG000|Participant Flow|Supplemental Oxygen|"Subjects in this arm will receive 10L/min via simple facemask~Device: simple facemask to administer supplemental oxygen"
11238602|NCT02464917|FG001|Participant Flow|Room Air|This control arm will receive no supplemental oxygen
11238603|NCT02464917|OG000|Outcome|Supplemental Oxygen|"Subjects in this arm will receive 10L/min via simple facemask~Device: simple facemask to administer supplemental oxygen"
11238604|NCT02464917|OG001|Outcome|Room Air|This control arm will receive no supplemental oxygen
11238605|NCT02464917|EG000|Reported Event|Supplemental Oxygen|"Subjects in this arm will receive 10L/min via simple facemask~Device: simple facemask to administer supplemental oxygen"
11238606|NCT02464917|EG001|Reported Event|Room Air|This control arm will receive no supplemental oxygen
11238607|NCT02465034|BG000|Baseline|Participants With Subcortical Stroke|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function undergoing noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was used where participants received traditional PAS and sham PAS or a cortico-cortical paired associative stimulation (CC-PAS) and sham CC-PAS. Participants also underwent median nerve stimulation.
11238608|NCT02465034|BG001|Baseline|Healthy Controls|Healthy individuals underwent noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was used where participants received traditional PAS and sham PAS.
11238609|NCT02465034|BG002|Baseline|Total|Total of all reporting groups
11238610|NCT02465034|FG000|Participant Flow|Participants With Subcortical Stroke|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function undergoing noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was used where participants received traditional PAS and sham PAS or a cortico-cortical paired associative stimulation (CC-PAS) and sham CC-PAS. Participants also underwent median nerve stimulation.
11238611|NCT02465034|FG001|Participant Flow|Healthy Controls|Healthy individuals underwent noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was used where participants received traditional PAS and sham PAS.
11238612|NCT02465034|OG000|Outcome|Subcortical Stroke PAS|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving paired associative stimulation (PAS). PAS is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. Median nerve stimuli at 300% of the perceptual threshold is applied 25ms prior to transcranial magnetic stimulation delivery over the ipsilesional (stroke) or non-dominant (control) cortex.
11238613|NCT02465034|OG001|Outcome|Subcortical Stroke PAS Sham|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham paired associative stimulation (PAS).
11238614|NCT02465034|OG002|Outcome|Subcortical Stroke CC-PAS|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.
11240797|NCT02481947|BG002|Baseline|Total|Total of all reporting groups
11240798|NCT02481947|FG000|Participant Flow|BLI400 Laxative|BLI400 Laxative (21 gm BLI400 powder per day)
11360098|NCT02715765|EG001|Reported Event|Active tDCS|"Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). The current is held constant for 20 min. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.~Transcranial Direct Current Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA."
11360099|NCT02715765|EG002|Reported Event|Active tRNS|"Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). Once at 2mA, an alternating current of 2mA with a 0mA offset is applied at random frequencies over a range of 0.1 to 100 Hz. This is performed for 20 minutes. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.~Transcranial Random Noise Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA."
11360100|NCT02717949|BG000|Baseline|Sofosbuvir and Ribavirin|"Sofosbuvir 400 mg given orally once a day with weight-base ribavirin of 1200 mg for those >75 kg and 1000 mg for those <75kg given in divided dose twice a day. This intervention is for genotype 2 and 3~sofosbuvir: sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally~Ribavirin: ribavirin 1200 mg given orally in divided dose for those >75kg and 1000 mg in divided dose for those <75 kg."
11360101|NCT02717949|BG001|Baseline|Sofosbuvir/Ledipasvir|"sofosbuvir and ledipasvir fixed dose combination given orally once a day for genotype 1 and 4.~sofosbuvir/ledipasvir: sofosbuvir ledipasvir fixed dose combination given once a day by mouth"
11360102|NCT02717949|BG002|Baseline|Total|Total of all reporting groups
11360103|NCT02717949|FG000|Participant Flow|Sofosbuvir/Ledipasvir|"sofosbuvir and ledipasvir fixed dose combination given orally once a day for genotype 1 and 4.~sofosbuvir/ledipasvir: sofosbuvir ledipasvir fixed dose combination given once a day by mouth"
11360104|NCT02717949|FG001|Participant Flow|Sofosbuvir and Ribavirin|"Sofosbuvir 400 mg given orally once a day with weight-base ribavirin of 1200 mg for those >75 kg and 1000 mg for those <75kg given in divided dose twice a day. This intervention is for genotype 2 and 3~sofosbuvir: sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally~Ribavirin: ribavirin 1200 mg given orally in divided dose for those >75kg and 1000 mg in divided dose for those <75 kg."
11360105|NCT02717949|OG000|Outcome|Sofosbuvir/Ledipasvir|"sofosbuvir and ledipasvir fixed dose combination given orally once a day for genotype 1 and 4.~sofosbuvir/ledipasvir: sofosbuvir ledipasvir fixed dose combination given once a day by mouth"
11360106|NCT02717949|OG001|Outcome|Sofosbuvir and Ribavirin|"Sofosbuvir 400 mg given orally once a day with weight-base ribavirin of 1200 mg for those >75 kg and 1000 mg for those <75kg given in divided dose twice a day. This intervention is for genotype 2 and 3~sofosbuvir: sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally~Ribavirin: ribavirin 1200 mg given orally in divided dose for those >75kg and 1000 mg in divided dose for those <75 kg."
11360107|NCT02717949|OG000|Outcome|Sofosbuvir and Ribavirin|"Sofosbuvir 400 mg given orally once a day with weight-base ribavirin of 1200 mg for those >75 kg and 1000 mg for those <75kg given in divided dose twice a day. This intervention is for genotype 2 and 3~sofosbuvir: sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally~Ribavirin: ribavirin 1200 mg given orally in divided dose for those >75kg and 1000 mg in divided dose for those <75 kg."
11360108|NCT02717949|OG001|Outcome|Sofosbuvir/Ledipasvir|"sofosbuvir and ledipasvir fixed dose combination given orally once a day for genotype 1 and 4.~sofosbuvir/ledipasvir: sofosbuvir ledipasvir fixed dose combination given once a day by mouth"
11360109|NCT02717949|EG000|Reported Event|Sofosbuvir/Ledipasvir|"sofosbuvir and ledipasvir fixed dose combination given orally once a day for genotype 1 and 4.~sofosbuvir/ledipasvir: sofosbuvir ledipasvir fixed dose combination given once a day by mouth"
11360110|NCT02717949|EG001|Reported Event|Sofosbuvir and Ribavirin|"Sofosbuvir 400 mg given orally once a day with weight-base ribavirin of 1200 mg for those >75 kg and 1000 mg for those <75kg given in divided dose twice a day. This intervention is for genotype 2 and 3~sofosbuvir: sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally~Ribavirin: ribavirin 1200 mg given orally in divided dose for those >75kg and 1000 mg in divided dose for those <75 kg."
11360111|NCT02717130|BG000|Baseline|Aripiprazole (Abilify Maintena)|Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
11360112|NCT02717130|FG000|Participant Flow|Aripiprazole (Abilify Maintena)|Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
11360113|NCT02717130|OG000|Outcome|Aripiprazole (Abilify Maintena)|Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
11360114|NCT02717130|EG000|Reported Event|Aripiprazole (Abilify Maintena)|Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
11360115|NCT02685202|BG000|Baseline|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient's mandibular in a forward position, clearing the obstructed airway during sleep."
11360116|NCT02685202|FG000|Participant Flow|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient's mandibular in a forward position, clearing the obstructed airway during sleep."
10962082|NCT00864682|FG000|Participant Flow|Control Arm|saline pretreatment, saline plus propofol admixture
11360117|NCT02685202|OG000|Outcome|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient's mandibular in a forward position, clearing the obstructed airway during sleep."
11360118|NCT02685202|EG000|Reported Event|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient's mandibular in a forward position, clearing the obstructed airway during sleep."
11360119|NCT02709083|BG000|Baseline|Treatment-dasatinib, Nilotinib, Imatinib|"Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.~Dasatinib: Given orally~Imatinib Mesylate: Given orally~Nilotinib: Given orally"
11360120|NCT02709083|FG000|Participant Flow|Treatment-dasatinib, Nilotinib, Imatinib|"Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.~Dasatinib: Given orally~Imatinib Mesylate: Given orally~Nilotinib: Given orally"
11360121|NCT02709083|OG000|Outcome|Treatment-dasatinib, Nilotinib, Imatinib|"Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.~Dasatinib: Given orally~Imatinib Mesylate: Given orally~Nilotinib: Given orally"
11360122|NCT02709083|EG000|Reported Event|Treatment-dasatinib, Nilotinib, Imatinib|"Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.~Dasatinib: Given orally~Imatinib Mesylate: Given orally~Nilotinib: Given orally"
11360123|NCT02693171|BG000|Baseline|Dinutuximab Administered for 5 Cycles|"High-risk neuroblastoma patient treated with Unituxin as standard of care~Dinutuximab: Unituxin was administered along with cytokines according to the prescribing information"
11360124|NCT02693171|FG000|Participant Flow|Dinutuximab Administered for 5 Cycles|"High-risk neuroblastoma patient treated with Unituxin as standard of care~Dinutuximab: Unituxin was administered along with cytokines according to the prescribing information"
11360125|NCT02693171|OG000|Outcome|Dinutuximab Administered for 5 Cycles|"High-risk neuroblastoma patient treated with Unituxin as standard of care~Dinutuximab: Unituxin will be administered along with cytokines according to the prescribing information"
11360126|NCT02693171|EG000|Reported Event|Dinutuximab Administered for 5 Cycles|"High-risk neuroblastoma patient treated with Unituxin as standard of care~Dinutuximab: Unituxin was administered along with cytokines according to the prescribing information"
11360127|NCT02696226|BG000|Baseline|SAVR Warfarin Arm|"Warfarin arm-(target INR of 2-3)~SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360128|NCT02696226|BG001|Baseline|TAVR Warfarin and Clopidogrel Arm|"Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm~TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360129|NCT02696226|BG002|Baseline|SAVR Aspirin Arm|"Aspirin arm (81mg/day)~SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care."
11360130|NCT02696226|BG003|Baseline|TAVR Aspirin and Clopidogrel Arm|"Aspirin (81mg/day) and Clopidogrel (75mg/day) arm~TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360131|NCT02696226|BG004|Baseline|Total|Total of all reporting groups
11360132|NCT02696226|FG000|Participant Flow|SAVR Warfarin Arm|"Warfarin arm-(target INR of 2-3)~SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360133|NCT02696226|FG001|Participant Flow|TAVR Warfarin and Clopidogrel Arm|"Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm~TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360134|NCT02696226|FG002|Participant Flow|SAVR Aspirin Arm|"Aspirin arm (81mg/day)~SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care."
11360135|NCT02696226|FG003|Participant Flow|TAVR Aspirin and Clopidogrel Arm|"Aspirin (81mg/day) and Clopidogrel (75mg/day) arm~TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11187516|NCT02106923|BG002|Baseline|1500mg, Fasted|Patients orally administered either 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h
11187517|NCT02106923|BG003|Baseline|Total|Total of all reporting groups
11187518|NCT02106923|FG000|Participant Flow|Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin (Empa)/1000 mg metformin (Met) extended release (XR) fixed dose combination (FDC) followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
11187519|NCT02106923|FG001|Participant Flow|Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
11187520|NCT02106923|FG002|Participant Flow|Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
11187521|NCT02106923|FG003|Participant Flow|Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
11187522|NCT02106923|FG004|Participant Flow|Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
11187523|NCT02106923|FG005|Participant Flow|Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR followed by oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
11187524|NCT02106923|OG000|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
11187525|NCT02106923|OG001|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
11187526|NCT02106923|OG002|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
11187527|NCT02106923|OG003|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
11187528|NCT02106923|OG004|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
11187529|NCT02106923|OG005|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
11187530|NCT02106923|EG000|Reported Event|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
11187531|NCT02106923|EG001|Reported Event|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
11187532|NCT02106923|EG002|Reported Event|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
11187533|NCT02106923|EG003|Reported Event|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
11187534|NCT02106923|EG004|Reported Event|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
11187535|NCT02106923|EG005|Reported Event|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
11187536|NCT02106962|BG000|Baseline|Topical Tranexamic Acid and Bacitracin 5%|Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time in the same participants that did not receive treatment at a subsequent dialysis session
11187537|NCT02106962|BG001|Baseline|Tranexamic Acid and Bacitracin 25%|Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time in the same participants that received treatment but at a subsequent dialysis session.
11187538|NCT02106962|BG002|Baseline|Total|Total of all reporting groups
11187539|NCT02106962|FG000|Participant Flow|Topical Tranexamic Acid 5%|Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
11187540|NCT02106962|FG001|Participant Flow|Topical Tranexamic Acid 25%|Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
11187541|NCT02106962|OG000|Outcome|Clotting Time Using Tranexamic Acid 5%|"Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis~Topical Tranexamic Acid 5% with bacitracin: Selected participants received a fixed amount of tranexamic acid 5 %and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site."
11238615|NCT02465034|OG003|Outcome|Subcortical Stroke CC-PAS Sham|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham cortico-cortical paired associative stimulation (CC-PAS).
11238616|NCT02465034|OG004|Outcome|Healthy Control Group|Healthy participants received noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was also used.
11240799|NCT02481947|FG001|Participant Flow|Lubiprostone|Lubiprostone (24 mcg capsule bid)
11240800|NCT02481947|OG000|Outcome|BLI400 Laxative|BLI400 Laxative (21 gm BLI400 powder)
11240801|NCT02481947|OG001|Outcome|Lubiprostone|Lubiprostone (24 mcg capsule bid)
11240802|NCT02481947|EG000|Reported Event|BLI400 Laxative|BLI400 Laxative (21 gm BLI400 powder)
11240803|NCT02481947|EG001|Reported Event|Lubiprostone|Lubiprostone (24 mcg capsule bid)
11240804|NCT02482025|BG000|Baseline|Usual Care|Usual care delivered at VA Boston
11240805|NCT02482025|BG001|Baseline|SMMRT|"Receives Usual Care PLUS SMMRT Intervention~SMMRT: Includes My HealtheVet registration and enrollment"
11240806|NCT02482025|BG002|Baseline|Total|Total of all reporting groups
11240807|NCT02482025|FG000|Participant Flow|Usual Care|Usual care delivered at VA Boston
11240808|NCT02482025|FG001|Participant Flow|SMMRT|"Receives Usual Care PLUS SMMRT Intervention~SMMRT: Includes My HealtheVet registration and enrollment"
11240809|NCT02482025|OG000|Outcome|Usual Care|Usual care delivered at VA Boston
11240810|NCT02482025|OG001|Outcome|SMMRT|"Receives Usual Care PLUS SMMRT Intervention~SMMRT: Includes My HealtheVet registration and enrollment"
11240811|NCT02482025|EG000|Reported Event|Usual Care|Usual care delivered at VA Boston
11240812|NCT02482025|EG001|Reported Event|SMMRT|"Receives Usual Care PLUS SMMRT Intervention~SMMRT: Includes My HealtheVet registration and enrollment"
11240813|NCT02482129|BG000|Baseline|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11240814|NCT02482129|BG001|Baseline|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11240815|NCT02482129|BG002|Baseline|Total|Total of all reporting groups
11240816|NCT02482129|FG000|Participant Flow|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11240817|NCT02482129|FG001|Participant Flow|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11240818|NCT02482129|OG000|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11240819|NCT02482129|OG001|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11240820|NCT02482129|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
11240821|NCT02482129|EG001|Reported Event|LME636|All subjects exposed to LME636 ophthalmic solution
11240822|NCT02482129|EG002|Reported Event|Dexamethasone|All subjects exposed to Dexamethasone ophthalmic solution
11240823|NCT02482129|EG003|Reported Event|Posttreatment|All subjects from the conclusion of treatment until exit from the study
11240824|NCT02482298|BG000|Baseline|PLACEBO 10MG BID + PLACEBO 45MG BID|
11240825|NCT02482298|BG001|Baseline|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
11240826|NCT02482298|BG002|Baseline|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
11240827|NCT02482298|BG003|Baseline|Total|Total of all reporting groups
11240828|NCT02482298|FG000|Participant Flow|PLACEBO 10MG BID + PLACEBO 45MG BID|
11240829|NCT02482298|FG001|Participant Flow|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
11240830|NCT02482298|FG002|Participant Flow|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
11240831|NCT02482298|OG000|Outcome|PLACEBO 10MG BID + PLACEBO 45MG BID|
11240832|NCT02482298|OG001|Outcome|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
11240833|NCT02482298|OG002|Outcome|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
11240834|NCT02482298|EG000|Reported Event|PLACEBO 10MG BID + PLACEBO 45MG BID|
11240835|NCT02482298|EG001|Reported Event|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
11240836|NCT02482298|EG002|Reported Event|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
11240837|NCT02482428|BG000|Baseline|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11240838|NCT02482428|BG001|Baseline|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11240839|NCT02482428|BG002|Baseline|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11240840|NCT02482428|BG003|Baseline|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11240841|NCT02482428|BG004|Baseline|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11240842|NCT02482428|BG005|Baseline|Total|Total of all reporting groups
11240843|NCT02482428|FG000|Participant Flow|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11240844|NCT02482428|FG001|Participant Flow|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11240845|NCT02482428|FG002|Participant Flow|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11240846|NCT02482428|FG003|Participant Flow|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11240847|NCT02482428|FG004|Participant Flow|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11240848|NCT02482428|OG000|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11240849|NCT02482428|OG001|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11238617|NCT02465034|OG005|Outcome|Healthy Control Sham|Healthy participants receiving sham paired associative stimulation (PAS).
11238618|NCT02465034|OG000|Outcome|Subcortical Stroke CC-PAS|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.
11238619|NCT02465034|OG001|Outcome|Subcortical Stroke CC-PAS Sham|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham cortico-cortical paired associative stimulation (CC-PAS).
11238620|NCT02465034|OG001|Outcome|Subcortical Stroke CC-PAS|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.
11238621|NCT02465034|OG001|Outcome|Subcortical Stroke CC-PAS Sham|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS).
11238622|NCT02465034|EG000|Reported Event|Participants With Subcortical Stroke|Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function undergoing noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation will also be used which will be one of the following, a traditional or a corticocortical or a sham paired associative stimulation protocol. The subjects also underwent median nerve stimulation.
11238623|NCT02465034|EG001|Reported Event|Healthy Controls|Healthy individuals underwent noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was also used, which was either a traditional or a corticocortical or a sham paired associative stimulation protocol.
11238624|NCT02465073|BG000|Baseline|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
11238625|NCT02465073|BG001|Baseline|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
11238626|NCT02465073|BG002|Baseline|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
11238627|NCT02465073|BG003|Baseline|Total|Total of all reporting groups
11238628|NCT02465073|FG000|Participant Flow|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
11238629|NCT02465073|FG001|Participant Flow|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
11238630|NCT02465073|FG002|Participant Flow|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
11238631|NCT02465073|OG000|Outcome|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
11238632|NCT02465073|OG001|Outcome|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
11238633|NCT02465073|OG002|Outcome|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
11238634|NCT02465073|EG000|Reported Event|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
11238635|NCT02465073|EG001|Reported Event|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
11238636|NCT02465073|EG002|Reported Event|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
11238637|NCT02465099|BG000|Baseline|Phase 1 Monopolar Electrocautery Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
11238638|NCT02465099|BG001|Baseline|Phase II OSTEOVUE Ultrasonic Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
11238639|NCT02465099|BG002|Baseline|Total|Total of all reporting groups
11238640|NCT02465099|FG000|Participant Flow|Phase 1 Monopolar Electrocautery Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
11238641|NCT02465099|FG001|Participant Flow|Phase II OSTEOVUE Ultrasonic Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
11238642|NCT02465099|OG000|Outcome|Phase 1 Monopolar Electrocautery Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
11238643|NCT02465099|OG001|Outcome|Phase II OSTEOVUE Ultrasonic Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
11238644|NCT02465099|EG000|Reported Event|Phase 1 Monopolar Electrocautery Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
11360136|NCT02696226|OG000|Outcome|SAVR Warfarin Arm|"Warfarin arm-(target INR of 2-3)~SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360137|NCT02696226|OG001|Outcome|TAVR Warfarin and Clopidogrel Arm|"Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm~TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360138|NCT02696226|OG002|Outcome|SAVR Aspirin Arm|"Aspirin arm (81mg/day)~SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care."
11360139|NCT02696226|OG003|Outcome|TAVR Aspirin and Clopidogrel Arm|"Aspirin (81mg/day) and Clopidogrel (75mg/day) arm~TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360140|NCT02696226|EG000|Reported Event|SAVR Warfarin Arm|"Warfarin arm-(target INR of 2-3)~SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360141|NCT02696226|EG001|Reported Event|TAVR Warfarin and Clopidogrel Arm|"Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm~TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360142|NCT02696226|EG002|Reported Event|SAVR Aspirin Arm|"Aspirin arm (81mg/day)~SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care."
11360143|NCT02696226|EG003|Reported Event|TAVR Aspirin and Clopidogrel Arm|"Aspirin (81mg/day) and Clopidogrel (75mg/day) arm~TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
11360144|NCT02693743|BG000|Baseline|Active rTMS|"Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered to the left PFC, deﬁned as a location 6 cm (cm) anterior to the right hand motor thumb area. A research nurse will deliver the treatments. rTMS will be delivered with a ﬁgure-eight coil at 120% motor threshold, 10 Hertz (Hz), 5 s (s) train duration, 20 s intertrain interval for 50 min (6000 pulses) 3 times daily for 3 days (total 9 sessions, 54,000 stimuli).~repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation."
11360145|NCT02693743|BG001|Baseline|Sham rTMS|"Parameters for sham Repetitive Transcranial Magnetic Stimulation (rTMS) are identical to those for active stimulation except that aluminum plate blocks the propagation of a magnetic field. The sound and physical sensation is the same as with the active coil while been biologically inactive.~repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation."
11360146|NCT02693743|BG002|Baseline|Total|Total of all reporting groups
11360147|NCT02693743|FG000|Participant Flow|Active rTMS|"Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered to the left PFC, deﬁned as a location 6 cm (cm) anterior to the right hand motor thumb area. A research nurse will deliver the treatments. rTMS will be delivered with a ﬁgure-eight coil at 120% motor threshold, 10 Hertz (Hz), 5 s (s) train duration, 20 s intertrain interval for 50 min (6000 pulses) 3 times daily for 3 days (total 9 sessions, 54,000 stimuli).~repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation."
11187542|NCT02106962|OG001|Outcome|Clotting Time Using Tranexamic Acid 25%|"Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis~Topical Tranexamic Acid 25% with bacitracin: Selected participants received a fixed amount of tranexamic acid 25%and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site."
11360148|NCT02693743|FG001|Participant Flow|Sham rTMS|"Parameters for sham Repetitive Transcranial Magnetic Stimulation (rTMS) are identical to those for active stimulation except that aluminum plate blocks the propagation of a magnetic field. The sound and physical sensation is the same as with the active coil while been biologically inactive.~repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation."
11187543|NCT02106962|OG000|Outcome|Topical Tranexamic Acid 5%|Measure clotting time of Native arteriovenous fistula after applying topical Tranexamic Acid 5% compared with normal clotting time
11360149|NCT02693743|OG000|Outcome|Active rTMS|"Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered to the left PFC, deﬁned as a location 6 cm (cm) anterior to the right hand motor thumb area. A research nurse will deliver the treatments. rTMS will be delivered with a ﬁgure-eight coil at 120% motor threshold, 10 Hertz (Hz), 5 s (s) train duration, 20 s intertrain interval for 50 min (6000 pulses) 3 times daily for 3 days (total 9 sessions, 54,000 stimuli).~repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation."
10962083|NCT00864682|FG001|Participant Flow|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
11187544|NCT02106962|OG001|Outcome|Topical Tranexamic Acid 25 %|Measure clotting time of Native arteriovenous fistula using Tranexamic acid 25% compared with normal clotting time
11187545|NCT02106962|EG000|Reported Event|Topical Tranexamic Acid 5% and Bacitracin|Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
11238645|NCT02465099|EG001|Reported Event|Phase II OSTEOVUE Ultrasonic Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
11238646|NCT02465203|BG000|Baseline|From Study 2210 (N=56)|Follow up from feeder study NCT01183169
11238647|NCT02465203|BG001|Baseline|From Study 2301 (N=36)|Follow up from withdrawn feeder study NCT01318694
11238648|NCT02465203|BG002|Baseline|Study 2211 - Overall (N=13)|Follow up from feeder study NCT01215643
11238649|NCT02465203|BG003|Baseline|Total|Total of all reporting groups
11238650|NCT02465203|FG000|Participant Flow|From Study 2210 (N=56)|Follow up from feeder study NCT01183169
11238651|NCT02465203|FG001|Participant Flow|From Study 2301 (N=36)|Follow up from withdrawn feeder study NCT01318694
11238652|NCT02465203|FG002|Participant Flow|From Study 2211 - Overall (N=13)|Follow up from feeder study NCT01215643
11238653|NCT02465203|OG000|Outcome|All Arms|All participants in study
11238654|NCT02465203|EG000|Reported Event|A2210|From Study A2210 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)
11238655|NCT02465203|EG001|Reported Event|A2301|From Study A2301 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)
11238656|NCT02465203|EG002|Reported Event|A2211 IFN-free|From Study A2211 IFN-free (subset of Study 2211 overall)
11238657|NCT02465203|EG003|Reported Event|A2211 Overall|From Study A2211 Overall (1 patient did not receive alisporivir in the feeder study and was excluded from Safety Set)
11238658|NCT02465216|BG000|Baseline|2 mcg ID93 + 2 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238659|NCT02465216|BG001|Baseline|10 mcg ID93 + 2 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238660|NCT02465216|BG002|Baseline|2 mcg ID93 + 5 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.~ID93 + GLA-SE: ID93 + GLA-SE"
11238661|NCT02465216|BG003|Baseline|2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses|"Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238662|NCT02465216|BG004|Baseline|Placebo|"Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.~Placebo: Placebo"
11238663|NCT02465216|BG005|Baseline|Total|Total of all reporting groups
11238664|NCT02465216|FG000|Participant Flow|2 mcg ID93 + 2 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238665|NCT02465216|FG001|Participant Flow|10 mcg ID93 + 2 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238666|NCT02465216|FG002|Participant Flow|2 mcg ID93 + 5 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.~ID93 + GLA-SE: ID93 + GLA-SE"
11238667|NCT02465216|FG003|Participant Flow|2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses|"Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238668|NCT02465216|FG004|Participant Flow|Placebo|"Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.~Placebo: Placebo"
11238669|NCT02465216|OG000|Outcome|2 mcg ID93 + 2 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238670|NCT02465216|OG001|Outcome|10 mcg ID93 + 2 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238671|NCT02465216|OG002|Outcome|2 mcg ID93 + 5 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.~ID93 + GLA-SE: ID93 + GLA-SE"
11238672|NCT02465216|OG003|Outcome|2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses|"Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238673|NCT02465216|OG004|Outcome|Placebo|"Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.~Placebo: Placebo"
11238674|NCT02465216|EG000|Reported Event|2 mcg ID93 + 2 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238675|NCT02465216|EG001|Reported Event|10 mcg ID93 + 2 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238676|NCT02465216|EG002|Reported Event|2 mcg ID93 + 5 mcg GLA-SE Vaccine|"Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.~ID93 + GLA-SE: ID93 + GLA-SE"
11238677|NCT02465216|EG003|Reported Event|2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses|"Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.~ID93 + GLA-SE: ID93 + GLA-SE"
11238678|NCT02465216|EG004|Reported Event|Placebo|"Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.~Placebo: Placebo"
11238679|NCT02465372|BG000|Baseline|CSPAP|"Schools in this arm will receive the Comprehensive School Physical Activity Program training.~CSPAP: Comprehensive School Physical Activity Program."
11238680|NCT02465372|BG001|Baseline|Control|Standard practice.
11238681|NCT02465372|BG002|Baseline|Total|Total of all reporting groups
11238682|NCT02465372|FG000|Participant Flow|CSPAP|"Schools in this arm will receive the Comprehensive School Physical Activity Program training.~CSPAP: Comprehensive School Physical Activity Program."
11238683|NCT02465372|FG001|Participant Flow|Control|Standard practice.
11238684|NCT02465372|OG000|Outcome|CSPAP|"Schools in this arm will receive the Comprehensive School Physical Activity Program training.~CSPAP: Comprehensive School Physical Activity Program."
11360150|NCT02693743|OG001|Outcome|Sham rTMS|"Parameters for sham Repetitive Transcranial Magnetic Stimulation (rTMS) are identical to those for active stimulation except that aluminum plate blocks the propagation of a magnetic field. The sound and physical sensation is the same as with the active coil while been biologically inactive.~repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation."
11360151|NCT02693743|EG000|Reported Event|Active rTMS|"Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered to the left PFC, deﬁned as a location 6 cm (cm) anterior to the right hand motor thumb area. A research nurse will deliver the treatments. rTMS will be delivered with a ﬁgure-eight coil at 120% motor threshold, 10 Hertz (Hz), 5 s (s) train duration, 20 s intertrain interval for 50 min (6000 pulses) 3 times daily for 3 days (total 9 sessions, 54,000 stimuli).~repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation."
11360152|NCT02693743|EG001|Reported Event|Sham rTMS|"Parameters for sham Repetitive Transcranial Magnetic Stimulation (rTMS) are identical to those for active stimulation except that aluminum plate blocks the propagation of a magnetic field. The sound and physical sensation is the same as with the active coil while been biologically inactive.~repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation."
11360153|NCT02706691|BG000|Baseline|BGJ398 (Infigratinib) Dosing|"Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.~BGJ398: Given by mouth (oral)"
11360154|NCT02706691|FG000|Participant Flow|BGJ398 (Infigratinib) Dosing|"Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.~BGJ398: Given by mouth (oral)"
11360155|NCT02706691|OG000|Outcome|BGJ398 (Infigratinib) Dosing|"Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.~BGJ398: Given by mouth (oral)"
11360156|NCT02706691|OG000|Outcome|BGJ398 (Infigratinib) Dosing|Patients treated with study drug.
11360157|NCT02706691|EG000|Reported Event|BGJ398 (Infigratinib) Dosing|"Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.~BGJ398: Given by mouth (oral)"
11360158|NCT02708849|BG000|Baseline|Ketamine Plus Lamotrigine|"Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion~Lamotrigine: lamotrigine (300 mg oral dose) or the matched-placebo control about 2-hours prior to the start of the infusion of ketamine"
11360159|NCT02708849|BG001|Baseline|Ketamine Plus Placebo|"Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion~Placebo: oral dose placebo"
11360160|NCT02708849|BG002|Baseline|Total|Total of all reporting groups
11360161|NCT02708849|FG000|Participant Flow|Ketamine Plus Lamotrigine|"Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion~Lamotrigine: lamotrigine (300 mg oral dose) or the matched-placebo control about 2-hours prior to the start of the infusion of ketamine"
11360162|NCT02708849|FG001|Participant Flow|Ketamine Plus Placebo|"Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion~Placebo: oral dose placebo"
11360163|NCT02708849|OG000|Outcome|Ketamine Plus Lamotrigine|"Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion~Lamotrigine: lamotrigine (300 mg oral dose) or the matched-placebo control about 2-hours prior to the start of the infusion of ketamine"
11360164|NCT02708849|OG001|Outcome|Ketamine Plus Placebo|"Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion~Placebo: oral dose placebo"
11360165|NCT02708849|EG000|Reported Event|Ketamine Plus Lamotrigine|"Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion~Lamotrigine: lamotrigine (300 mg oral dose) or the matched-placebo control about 2-hours prior to the start of the infusion of ketamine"
11360166|NCT02708849|EG001|Reported Event|Ketamine Plus Placebo|"Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion~Placebo: oral dose placebo"
11360167|NCT02693717|BG000|Baseline|Pemetrexed|Intravenous infusion 500 mg/m2 every 21 days
11360168|NCT02693717|FG000|Participant Flow|Pemetrexed|Intravenous infusion 500 mg/m2 every 21 days
11360169|NCT02693717|OG000|Outcome|Pemetrexed|Intravenous infusion 500 mg/m2 every 21 days
11360170|NCT02693717|EG000|Reported Event|Pemetrexed|Intravenous infusion 500 mg/m2 every 21 days
11360171|NCT02694757|BG000|Baseline|Ostom-i Device|"Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application.~Ostom-i device: The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the ostomy. It is an FDA approved medical device."
11360172|NCT02694757|FG000|Participant Flow|Ostom-i Device|"Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application.~Ostom-i device: The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the ostomy. It is an FDA approved medical device."
11238685|NCT02465372|OG001|Outcome|Control|Standard practice.
11238686|NCT02465372|EG000|Reported Event|CSPAP|"Schools in this arm will receive the Comprehensive School Physical Activity Program training.~CSPAP: Comprehensive School Physical Activity Program."
11238687|NCT02465372|EG001|Reported Event|Control|Standard practice.
11238688|NCT02465437|BG000|Baseline|Lenabasum (JBT-101) 5 mg QD/20 mg BID|Lenabasum 5 mg QAM and placebo QPM on Days 1-28, then lenabasum 20 mg BID on Days 29-84.
11238689|NCT02465437|BG001|Baseline|Lenabasum (JBT-101) 20 mg QD/20 mg BID|Lenabasum 20 mg QAM and placebo QPM on Days 1-28, then lenabasum 20 mg BID on Days 29-84.
11238690|NCT02465437|BG002|Baseline|Lenabasum (JBT-101) 20 mg BID/20 mg BID|Lenabasum 20 mg BID on Days 1-84.
11238691|NCT02465437|BG003|Baseline|Placebo|Placebo BID on Days 1-84.
11238692|NCT02465437|BG004|Baseline|Total|Total of all reporting groups
11238693|NCT02465437|FG000|Participant Flow|Lenabasum (JBT-101) 5 mg QD/20 mg BID|Lenabasum 5 mg QAM and placebo QPM on Days 1-28, then lenabasum 20 mg BID on Days 29-84.
11238694|NCT02465437|FG001|Participant Flow|Lenabasum (JBT-101) 20 mg QD/20 mg BID|Lenabasum 20 mg QAM and placebo QPM on Days 1-28, then lenabasum 20 mg BID on Days 29-84.
11238695|NCT02465437|FG002|Participant Flow|Lenabasum (JBT-101) 20 mg BID/20 mg BID|Lenabasum 20 mg BID on Days 1-84.
11238696|NCT02465437|FG003|Participant Flow|Placebo|Placebo BID on Days 1-84.
11238697|NCT02465437|OG000|Outcome|Placebo|Placebo BID on Days 1-84.
11238698|NCT02465437|OG001|Outcome|Combined Lenabasum Group|Combination of all lenabasum cohorts for analysis purposes only.
11238699|NCT02465437|OG000|Outcome|Combined Lenabasum Cohorts|This analysis group combines data from lenabasum Cohort 1 (5 mg QD/20mg BID), Cohort 2 (20 mg QD/20 mg BID), and Cohort 3 (20 mg BID/20 mg BID) for analysis purposes only.
11238700|NCT02465437|OG001|Outcome|Placebo|Placebo subjects in this study received placebo for the entire duration of the trial.
11238701|NCT02465437|EG000|Reported Event|Placebo (Days 1 - 84 + After-treatment Period)|Placebo cohort for the overall study.
11238702|NCT02465437|EG001|Reported Event|Combined Lenabasum (Days 1 - 84 + After-treatment Period)|Combined lenabasum cohorts for the overall study.
11238703|NCT02465450|BG000|Baseline|JBT101 1 mg QD, 20 mg QD, or 20 mg BID|JBT-101: 1 mg once a day on Days 1-28 and either 20 mg QD or 20 mg BID on Days 29-84.
11238704|NCT02465450|BG001|Baseline|JBT-101 5 mg QD,20 mg QD, or 20 mg BID|JBT-101: 5 mg once a day on Days 1-28 and either 20 mg QD or 20 mg BID on Days 29-84.
11238705|NCT02465450|BG002|Baseline|Placebo QD,20 mg QD, 20 mg BID, or Placebo BID|Placebo: Subjects received placebo on Days 1 - 28 and either 20 mg QD, 20 mg BID, or Placebo on Days 29-84.
11238706|NCT02465450|BG003|Baseline|Total|Total of all reporting groups
11238707|NCT02465450|FG000|Participant Flow|JBT101 1 mg QD|JBT-101: 1 mg once a day on Days 1-28
11238708|NCT02465450|FG001|Participant Flow|JBT-101 5 mg QD|JBT-101: 5 mg once a day on Days 1-28.
11238709|NCT02465450|FG002|Participant Flow|Placebo QD|Placebo: Subjects received placebo on Days 1 - 28.
11238710|NCT02465450|FG003|Participant Flow|JBT-101 20 mg QD|"JBT-101: 20 mg once a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
11238711|NCT02465450|FG004|Participant Flow|JBT-101 20 mg BID|"JBT-101: 20 mg twice a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
11238712|NCT02465450|FG005|Participant Flow|Placebo BID|"Placebo administered twice daily.~Subjects in this analysis group received placebo on Days 1 - 28."
11238713|NCT02465450|OG000|Outcome|JBT101 1 mg QD|JBT-101: 1 mg once a day on Days 1-28
11238714|NCT02465450|OG001|Outcome|JBT-101 5 mg QD|JBT-101: 5 mg once a day on Days 1-28.
11238715|NCT02465450|OG002|Outcome|Placebo QD|Placebo: Subjects received placebo on Days 1 - 28.
11238716|NCT02465450|OG003|Outcome|JBT-101 20 mg QD|"JBT-101: 20 mg once a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
11238717|NCT02465450|OG004|Outcome|JBT-101 20 mg BID|"JBT-101: 20 mg twice a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
11238718|NCT02465450|OG005|Outcome|Placebo BID|"Placebo administered twice daily.~Subjects in this analysis group received placebo on Days 1 - 28."
11238719|NCT02465450|OG000|Outcome|Lenabasum 1 mg QD|Lenabasum: 1 mg once a day on Days 1-28
11238720|NCT02465450|OG001|Outcome|Lenabasum 5 mg QD|Lenabasum: 5 mg once a day on Days 1-28.
11238721|NCT02465450|OG003|Outcome|Lenabasum 20 mg QD|"Lenabasum: 20 mg once a day on Days 29 - 84.~Lenabasum: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
11238722|NCT02465450|OG004|Outcome|Lenabasum 20 mg BID|"Lenabasum: 20 mg twice a day on Days 29 - 84.~Lenabasum: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
11238723|NCT02465450|EG000|Reported Event|JBT101 1 mg QD|JBT-101: 1 mg once a day on Days 1-28
11238724|NCT02465450|EG001|Reported Event|JBT-101 5 mg QD|JBT-101: 5 mg once a day on Days 1-28.
11238725|NCT02465450|EG002|Reported Event|Placebo QD|Placebo: Subjects received placebo on Days 1 - 28.
11238726|NCT02465450|EG003|Reported Event|JBT-101 20 mg QD|"JBT-101: 20 mg once a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
11238727|NCT02465450|EG004|Reported Event|JBT-101 20 mg BID|"JBT-101: 20 mg twice a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
11238728|NCT02465450|EG005|Reported Event|Placebo BID|"Placebo administered twice daily.~Subjects in this analysis group received placebo on Days 1 - 28."
11238729|NCT02465463|BG000|Baseline|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
11238730|NCT02465463|BG001|Baseline|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
11238731|NCT02465463|BG002|Baseline|Total|Total of all reporting groups
11240850|NCT02482428|OG002|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
11187546|NCT02106962|EG001|Reported Event|Topical Tranexamic Acid 25% and Bacitracin|Topical Tranexamic Acid 25% with bacitracin was applied to the arterio-venous fistula site after completing dialysis, to measure clotting time at a subsequent dialysis session.
11360173|NCT02694757|OG000|Outcome|Ostom-i Device|"Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application.~Ostom-i device: The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the ostomy. It is an FDA approved medical device."
11360174|NCT02694757|EG000|Reported Event|Ostom-i Device|"Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application.~Ostom-i device: The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the ostomy. It is an FDA approved medical device."
11360175|NCT02693002|BG000|Baseline|Hormone Replacement Therapy|"Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks~Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg"
11360176|NCT02693002|BG001|Baseline|Placebo|"Inert ingredients by mouth oral daily for 12 weeks~Placebo: inactive ingredient"
11360177|NCT02693002|BG002|Baseline|Total|Total of all reporting groups
11360178|NCT02693002|FG000|Participant Flow|Hormone Replacement Therapy|"Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks~Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg"
11360179|NCT02693002|FG001|Participant Flow|Placebo|"Inert ingredients by mouth oral daily for 12 weeks~Placebo: inactive ingredient"
11360180|NCT02693002|OG000|Outcome|Hormone Replacement Therapy|"Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks~Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg"
11360181|NCT02693002|OG001|Outcome|Placebo|"Inert ingredients by mouth oral daily for 12 weeks~Placebo: inactive ingredient"
11360182|NCT02693002|EG000|Reported Event|Hormone Replacement Therapy|"Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks~Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg"
11360183|NCT02693002|EG001|Reported Event|Placebo|"Inert ingredients by mouth oral daily for 12 weeks~Placebo: inactive ingredient"
11360184|NCT02689518|BG000|Baseline|Treatment - On-Label|"On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months~Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months."
11187547|NCT02106975|BG000|Baseline|Ascorbic Acid|"200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours~Ascorbic Acid: Intervention"
11187548|NCT02106975|BG001|Baseline|5% Dextrose in Water|"50ml every 6 hours for 96 hours~Placebo: 5% Dextrose in water: Placebo"
11360185|NCT02689518|FG000|Participant Flow|Treatment - On-Label|"On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months~Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months."
11360186|NCT02689518|OG000|Outcome|Treatment - On-Label|"On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months~Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months."
11360187|NCT02689518|EG000|Reported Event|Treatment - On-Label|"On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months~Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months."
11360188|NCT02687165|BG000|Baseline|All Participants|participants were not randomized. reporting all subjects together.
11360189|NCT02687165|FG000|Participant Flow|Milnacipran Augmented by D-cycloserine|"participants will be receiving Milnacipran for 12 weeks. During weeks 6-12 participants will be receiving D-cycloserine in addition to Milnacipran~Milnacipran and D-cycloserine: Milnacipran augmented by D-cycloserine"
11360190|NCT02687165|FG001|Participant Flow|Milnacipran Augmented by Placebo|"participants will be receiving Milnacipran for 12 weeks. During weeks 6-12 participants will be receiving placebo in addition to Milnacipran~Milnacipran and D-cycloserine: Milnacipran augmented by D-cycloserine"
11360191|NCT02687165|OG000|Outcome|Milnacipran Augmented by D-cycloserine|"participants will be receiving Milnacipran for 12 weeks. During weeks 6-12 participants will be receiving D-cycloserine in addition to Milnacipran~Milnacipran and D-cycloserine: Milnacipran augmented by D-cycloserine"
10962084|NCT00864682|FG002|Participant Flow|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
11187549|NCT02106975|BG002|Baseline|Total|Total of all reporting groups
11187550|NCT02106975|FG000|Participant Flow|Ascorbic Acid|"200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours~Ascorbic Acid: Intervention"
11187551|NCT02106975|FG001|Participant Flow|5% Dextrose in Water|"50ml every 6 hours for 96 hours~Placebo: 5% Dextrose in water: Placebo"
11360192|NCT02687165|OG001|Outcome|Milnacipran Augmented by Placebo|"participants will be receiving Milnacipran for 12 weeks. During weeks 6-12 participants will be receiving placebo in addition to Milnacipran~Milnacipran and D-cycloserine: Milnacipran augmented by D-cycloserine"
11187552|NCT02106975|OG000|Outcome|Ascorbic Acid|"200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours~Ascorbic Acid: Intervention"
11187553|NCT02106975|OG001|Outcome|5% Dextrose in Water|"50ml every 6 hours for 96 hours~Placebo: 5% Dextrose in water: Placebo"
11187554|NCT02106975|EG000|Reported Event|Ascorbic Acid|"200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours~Ascorbic Acid: Intervention"
11187555|NCT02106975|EG001|Reported Event|5% Dextrose in Water|"50ml every 6 hours for 96 hours~Placebo: 5% Dextrose in water: Placebo"
11187556|NCT02107014|BG000|Baseline|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
11187557|NCT02107014|FG000|Participant Flow|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
11187558|NCT02107014|OG000|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
11187559|NCT02107014|EG000|Reported Event|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
11187560|NCT02107092|BG000|Baseline|Extended Dosing Phase: ZS (Sodium Zirconium Cyclosilicate) QD|ZS 10g QD starting dose. ZS dose was increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g every other day (QOD) if i-STAT potassium values increased to > 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.
11187561|NCT02107092|FG000|Participant Flow|Extended Dosing Phase: ZS (Sodium Zirconium Cyclosilicate) QD|ZS 10g QD starting dose. ZS dose was increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g every other day (QOD) if i-STAT potassium values increased to > 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.
11187562|NCT02107092|OG000|Outcome|Extended Dosing Phase: ZS (Sodium Zirconium Cyclosilicate) QD|ZS 10g QD starting dose. ZS dose was increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g every other day (QOD) if i-STAT potassium values increased to > 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.
11187563|NCT02107092|EG000|Reported Event|ZS (Sodium Zirconium Cyclosilicate) QD Extended Phase Dosing|ZS 10g QD starting dose increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g QOD if i-STAT potassium values increased to > 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.
11187564|NCT02107131|BG000|Baseline|Monthly|Monthly Intravitreal ranibizumab 0.3mg
11187565|NCT02107131|BG001|Baseline|PRN Group|PRN Intravitreal ranibizumab 0.3mg
11187566|NCT02107131|BG002|Baseline|Total|Total of all reporting groups
11187567|NCT02107131|FG000|Participant Flow|Monthly|Monthly Intravitreal ranibizumab 0.3mg
11187568|NCT02107131|FG001|Participant Flow|PRN Group|PRN Intravitreal ranibizumab 0.3mg
11187569|NCT02107131|OG000|Outcome|Monthly|Monthly Intravitreal ranibizumab 0.3mg
11187570|NCT02107131|OG001|Outcome|PRN Group|PRN Intravitreal ranibizumab 0.3mg
11187571|NCT02107131|OG000|Outcome|Monthly Intravitreal Ranibizumab 0.3mg|"Monthly Intravitreal ranibizumab 0.3mg injections.~Intravitreal ranibizumab 0.3mg"
11187572|NCT02107131|OG001|Outcome|PRN Intravitreal Ranibizumab 0.3mg|"PRN Intravitreal ranibizumab 0.3mg injections.~Intravitreal ranibizumab 0.3mg"
11187573|NCT02107131|EG000|Reported Event|Monthly|Monthly Intravitreal ranibizumab 0.3mg
11187574|NCT02107131|EG001|Reported Event|PRN Group|PRN Intravitreal ranibizumab 0.3mg
11187575|NCT02107157|BG000|Baseline|755nm Alexandrite Laser With Cap Array- Acne|755nm Laser with Cap Array
11187576|NCT02107157|BG001|Baseline|755nm Alexandrite Laser With Cap Array- Photodamage|755nm Laser with Cap Array
11187577|NCT02107157|BG002|Baseline|755nm Laser With Cap Array- Biopsy|755nm Laser with Cap Array
11187578|NCT02107157|BG003|Baseline|Total|Total of all reporting groups
11187579|NCT02107157|FG000|Participant Flow|755nm Alexandrite Laser With Cap Array- Acne|"755nm Laser with Cap Array~Treatment of acne in the facial region."
11187580|NCT02107157|FG001|Participant Flow|755nm Alexandrite Laser With Cap Array- Photodamage|"755nm Laser with Cap Array~Treatment of photodamage in the facial region."
11187581|NCT02107157|FG002|Participant Flow|755nm Alexandrite Laser With Cap Array- Biopsy|"755nm Laser with Cap Array~Biopsy samples were taken of subjects."
11187582|NCT02107157|OG000|Outcome|755nm Alexandrite Laser With Cap Array- Acne|"755nm Laser with Cap Array~Treatment of acne in the facial region."
11187583|NCT02107157|OG000|Outcome|755nm Alexandrite Laser With Cap Array- Photodamage|"755nm Laser with Cap Array~Treatment of photodamage in the facial region."
11187584|NCT02107157|OG000|Outcome|755nm Alexandrite Laser With Cap Array- Biopsy|"755nm Laser with Cap Array~Biopsy samples were taken of subjects."
10962085|NCT00864682|OG000|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
11187585|NCT02107157|EG000|Reported Event|755nm Alexandrite Laser With Cap Array- Acne|755nm Laser with Cap Array
11187586|NCT02107157|EG001|Reported Event|755nm Alexandrite Laser With Cap Array- Photodamage|755nm Laser with Cap Array
11360193|NCT02687165|EG000|Reported Event|Milnacipran Augmented by D-cycloserine|"participants will be receiving Milnacipran for 12 weeks. During weeks 6-12 participants will be receiving D-cycloserine in addition to Milnacipran~Milnacipran and D-cycloserine: Milnacipran augmented by D-cycloserine"
11360194|NCT02687165|EG001|Reported Event|Milnacipran Augmented by Placebo|"participants will be receiving Milnacipran for 12 weeks. During weeks 6-12 participants will be receiving placebo in addition to Milnacipran~Milnacipran and D-cycloserine: Milnacipran augmented by D-cycloserine"
11360195|NCT02679560|BG000|Baseline|Liposomal Bupivacaine|"In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered~Liposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine"
11360196|NCT02679560|BG001|Baseline|Ropivacaine HCL|"In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered~Ropivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally."
11360197|NCT02679560|BG002|Baseline|Total|Total of all reporting groups
11360198|NCT02679560|FG000|Participant Flow|Liposomal Bupivacaine|"In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered~Liposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine"
11360199|NCT02679560|FG001|Participant Flow|Ropivacaine HCL|"In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered~Ropivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally."
11360200|NCT02679560|OG000|Outcome|Liposomal Bupivacaine|"In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered~Liposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine"
11360201|NCT02679560|OG001|Outcome|Ropivacaine HCL|"In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered~Ropivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally."
11360202|NCT02679560|EG000|Reported Event|Liposomal Bupivacaine|"In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered~Liposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine"
11360203|NCT02679560|EG001|Reported Event|Ropivacaine HCL|"In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered~Ropivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally."
11360204|NCT02679066|BG000|Baseline|Sugar-tong Splint|"Patients are placed in a sugar-tong splint for immobilization of the distal radius fracture.~Sugar-tong splint: Plaster immobilization including the elbow"
11360205|NCT02679066|BG001|Baseline|Short Forearm Cast|"Patients are placed in a short forearm cast, with bivalve, for immobilization of the distal radius fracture.~Short forearm cast: Fiberglass immobilization with elbow free"
11360206|NCT02679066|BG002|Baseline|Total|Total of all reporting groups
11360207|NCT02679066|FG000|Participant Flow|Sugar-tong Splint|"Patients are placed in a sugar-tong splint for immobilization of the distal radius fracture.~Sugar-tong splint: Plaster immobilization including the elbow"
11360208|NCT02679066|FG001|Participant Flow|Short Forearm Cast|"Patients are placed in a short forearm cast, with bivalve, for immobilization of the distal radius fracture.~Short forearm cast: Fiberglass immobilization with elbow free"
11360209|NCT02679066|OG000|Outcome|Sugar-tong Splint|"Patients are placed in a sugar-tong splint for immobilization of the distal radius fracture.~Sugar-tong splint: Plaster immobilization including the elbow"
11360210|NCT02679066|OG001|Outcome|Short Forearm Cast|"Patients are placed in a short forearm cast, with bivalve, for immobilization of the distal radius fracture.~Short forearm cast: Fiberglass immobilization with elbow free"
11360211|NCT02679066|EG000|Reported Event|Sugar-tong Splint|"Patients are placed in a sugar-tong splint for immobilization of the distal radius fracture.~Sugar-tong splint: Plaster immobilization including the elbow"
11360212|NCT02679066|EG001|Reported Event|Short Forearm Cast|"Patients are placed in a short forearm cast, with bivalve, for immobilization of the distal radius fracture.~Short forearm cast: Fiberglass immobilization with elbow free"
11360213|NCT02673684|BG000|Baseline|Sham NSS|"In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device.~Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear."
11360214|NCT02673684|BG001|Baseline|NSS (Working Device)|"In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device.~Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear."
11360215|NCT02673684|BG002|Baseline|Total|Total of all reporting groups
11360216|NCT02673684|FG000|Participant Flow|Sham NSS|"In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device.~Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear."
11360217|NCT02673684|FG001|Participant Flow|NSS (Working Device)|"In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device.~Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear."
11360218|NCT02673684|OG000|Outcome|NSS (Working Device)|"In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device.~Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear."
11360219|NCT02673684|OG001|Outcome|Sham NSS|"In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device.~Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear."
11360220|NCT02673684|OG000|Outcome|Sham NSS|"In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device.~Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear."
11360221|NCT02673684|OG001|Outcome|NSS (Working Device)|"In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device.~Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear."
11360222|NCT02673684|EG000|Reported Event|Sham NSS|"In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device.~Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear."
11360223|NCT02673684|EG001|Reported Event|NSS (Working Device)|"In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device.~Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear."
11360224|NCT02674204|BG000|Baseline|Study Agent|"One atorvastatin 20 mg oral capsule per day~Atorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis."
11360225|NCT02674204|BG001|Baseline|Control|"One matching placebo daily~Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent."
11360226|NCT02674204|BG002|Baseline|Total|Total of all reporting groups
11360227|NCT02674204|FG000|Participant Flow|Study Agent|"One atorvastatin 20 mg oral capsule per day~Atorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis."
11360228|NCT02674204|FG001|Participant Flow|Control|"One matching placebo daily~Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent."
11360229|NCT02674204|OG000|Outcome|Study Agent|"One atorvastatin 20 mg oral capsule per day~Atorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis."
11360230|NCT02674204|OG001|Outcome|Control|"One matching placebo daily~Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent."
11360231|NCT02674204|EG000|Reported Event|Study Agent|"One atorvastatin 20 mg oral capsule per day~Atorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis."
11360232|NCT02674204|EG001|Reported Event|Control|"One matching placebo daily~Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent."
11360233|NCT02665221|BG000|Baseline|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
10962086|NCT00864682|OG001|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
11238732|NCT02465463|FG000|Participant Flow|FMT Arm|"Patients in the experimental arm underwent a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool was infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
11238733|NCT02465463|FG001|Participant Flow|Control|Patients in the non-interventional group did not receive a FMT but were followed over the course of 6 months to assess for recurrence of C.difficile.
11238734|NCT02465463|OG000|Outcome|FMT Arm|"Patients in the experimental arm will undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
11238735|NCT02465463|OG001|Outcome|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
11238736|NCT02465463|OG000|Outcome|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
11238737|NCT02465463|EG000|Reported Event|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
11238738|NCT02465463|EG001|Reported Event|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
11238739|NCT02465489|BG000|Baseline|Healthy Volunteers|"Subjects were randomized to receive five treatments in different orders:~deferiprone ER tablets under fasting conditions~deferiprone ER tablets under fed conditions~deferiprone ER tablets administered as half-tablets under fed conditions~Ferriprox IR tablets under fasting conditions~Ferriprox IR tablets under fed conditions"
11238740|NCT02465489|FG000|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following five treatments in different orders, with a 7-day washout period between treatments::~A: Deferiprone ER tablets under fasting conditions B: Deferiprone ER tablets under fed conditions C: Deferiprone ER tablets administered as half-tablets under fed conditions D: Ferriprox IR tablets under fasting conditions E: Ferriprox IR tablets under fed conditions~The sequences were as follows;~Sequence 1 (n=4): A-B-E-C-D~Sequence 2 (n=4): B-C-A-D-E~Sequence 3 (n=4): C-D-B-E-A~Sequence 4 (n=4): D-E-C-A-B~Sequence 5 (n=4): E-A-D-B-C"
11238741|NCT02465489|OG000|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
11238742|NCT02465489|OG001|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
11238743|NCT02465489|OG002|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
11238744|NCT02465489|OG003|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
11238745|NCT02465489|OG004|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
11238746|NCT02465489|EG000|Reported Event|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
11238747|NCT02465489|EG001|Reported Event|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
11238748|NCT02465489|EG002|Reported Event|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
11238749|NCT02465489|EG003|Reported Event|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
11238750|NCT02465489|EG004|Reported Event|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
11238751|NCT02465515|BG000|Baseline|Placebo|Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health.
11238752|NCT02465515|BG001|Baseline|Albiglutide|Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health..
11238753|NCT02465515|BG002|Baseline|Total|Total of all reporting groups
11238754|NCT02465515|FG000|Participant Flow|Placebo|Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health.
11238755|NCT02465515|FG001|Participant Flow|Albiglutide|Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health.
10962087|NCT00864682|OG002|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
10962088|NCT00864682|EG000|Reported Event|Control Arm|saline pretreatment, saline plus propofol admixture
10962089|NCT00864682|EG001|Reported Event|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
11187587|NCT02107157|EG002|Reported Event|755nm Alexandrite Laser With Cap Array- Biopsy|755nm Laser with Cap Array
11240851|NCT02482428|OG003|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11240852|NCT02482428|OG002|Outcome|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11240853|NCT02482428|OG003|Outcome|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11240854|NCT02482428|OG004|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11240855|NCT02482428|EG000|Reported Event|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11240856|NCT02482428|EG001|Reported Event|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11240857|NCT02482428|EG002|Reported Event|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11240858|NCT02482428|EG003|Reported Event|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11240859|NCT02482428|EG004|Reported Event|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11240860|NCT02482571|BG000|Baseline|Mild Hypoxia|During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% (equivalent to an altitude of 4000 meters). During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional magnetic resonance spectroscopy (fMRS) while they are presented with visual stimuli.
11240861|NCT02482571|FG000|Participant Flow|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12%. During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
11240862|NCT02482571|OG000|Outcome|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12%. During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
11240863|NCT02482571|OG000|Outcome|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% . During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
11240864|NCT02482571|EG000|Reported Event|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% (equivalent to an altitude of 4000 meters). During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
11240865|NCT02482610|BG000|Baseline|All Study Participants|"Participants who were randomized to receive either Glucose, Glucose + Whole Fat Milk, or Glucose + Non-fat Milk. All participants received all three treatments in a randomized order.~Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose + Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose + Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes."
11240866|NCT02482610|FG000|Participant Flow|Glucose, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes."
11336610|NCT03569098|EG004|Reported Event|Open-Label Treatment Period (Cycle 3): Dysport 300 U|"On Cycle 3 Day 1 in the open-label treatment period, all participants who met retreatment criteria received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11360234|NCT02665221|BG001|Baseline|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11360235|NCT02665221|BG002|Baseline|Total|Total of all reporting groups
11360236|NCT02665221|FG000|Participant Flow|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11360237|NCT02665221|FG001|Participant Flow|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11360238|NCT02665221|OG000|Outcome|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11360239|NCT02665221|OG001|Outcome|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11360240|NCT02665221|EG000|Reported Event|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11360241|NCT02665221|EG001|Reported Event|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11360242|NCT02672033|BG000|Baseline|Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)|"Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.~Hypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT~Intensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo pleurectomy/decortication"
11360243|NCT02672033|FG000|Participant Flow|Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)|"Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.~Hypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT~Intensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo pleurectomy/decortication"
11360244|NCT02672033|OG000|Outcome|Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)|"Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.~Hypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT~Intensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo pleurectomy/decortication"
11360245|NCT02672033|EG000|Reported Event|Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)|"Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.~Hypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT~Intensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo pleurectomy/decortication"
11360246|NCT02671461|BG000|Baseline|Placebo|Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141
11360247|NCT02671461|BG001|Baseline|BMS-986141 0.8 mg|BMS-986141 0.8 mg QD for up to 28 days
11360248|NCT02671461|BG002|Baseline|BMS-986141 4.8 mg|BMS-986141 4.8 mg QD for up to 28 days
11360249|NCT02671461|BG003|Baseline|Total|Total of all reporting groups
11360250|NCT02671461|FG000|Participant Flow|Placebo|Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141
11360251|NCT02671461|FG001|Participant Flow|BMS-986141 0.8 mg|BMS-986141 0.8 mg QD for up to 28 days
11360252|NCT02671461|FG002|Participant Flow|BMS-986141 4.8 mg|BMS-986141 4.8 mg QD for up to 28 days
11360253|NCT02671461|OG000|Outcome|Placebo|Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141
11360254|NCT02671461|OG001|Outcome|BMS-986141 0.8 mg|BMS-986141 0.8 mg QD for up to 28 days
11360255|NCT02671461|OG002|Outcome|BMS-986141 4.8 mg|BMS-986141 4.8 mg QD for up to 28 days
11360256|NCT02671461|EG000|Reported Event|Placebo|Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141
11360257|NCT02671461|EG001|Reported Event|BMS-986141 0.8 mg|BMS-986141 0.8 mg QD for up to 28 days
11360258|NCT02671461|EG002|Reported Event|BMS-986141 4.8 mg|BMS-986141 4.8 mg QD for up to 28 days
11360259|NCT02671136|BG000|Baseline|CWC With HBO|"Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy~Hyperbaric Oxygen therapy~Conventional Wound Therapies"
11360260|NCT02671136|BG001|Baseline|CWC Without HBO|"Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy~Conventional Wound Therapies"
11360261|NCT02671136|BG002|Baseline|Total|Total of all reporting groups
11360262|NCT02671136|FG000|Participant Flow|CWC With HBO|"Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy~Hyperbaric Oxygen therapy~Conventional Wound Therapies"
11360263|NCT02671136|FG001|Participant Flow|CWC Without HBO|"Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy~Conventional Wound Therapies"
11360264|NCT02671136|OG000|Outcome|CWC With HBO|"Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy~Hyperbaric Oxygen therapy~Conventional Wound Therapies"
11360265|NCT02671136|OG001|Outcome|CWC Without HBO|"Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy~Conventional Wound Therapies"
11360266|NCT02671136|EG000|Reported Event|CWC With HBO|"Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy~Hyperbaric Oxygen therapy~Conventional Wound Therapies"
11360267|NCT02671136|EG001|Reported Event|CWC Without HBO|"Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy~Conventional Wound Therapies"
11360268|NCT02663752|BG000|Baseline|Deferasirox|All patients are already on commercial deferasirox before entering the study.
11360269|NCT02663752|FG000|Participant Flow|Deferasirox|All patients are already on commercial deferasirox before entering the study.
11360270|NCT02663752|OG000|Outcome|Deferasirox|All patients are already on commercial deferasirox before entering the study.
11360271|NCT02663752|EG000|Reported Event|Deferasirox|All patients are already on commercial deferasirox before entering the study.
11360272|NCT02658357|BG000|Baseline|600 mg|"Two, 300 mg Risperidone Implants~Risperidone Implant"
11360273|NCT02658357|BG001|Baseline|900 mg|"Three, 300 mg Risperidone Implants~Risperidone Implant"
11360274|NCT02658357|BG002|Baseline|Total|Total of all reporting groups
11360275|NCT02658357|FG000|Participant Flow|600 mg|"Two, 300 mg Risperidone Implants~Risperidone Implant"
11360276|NCT02658357|FG001|Participant Flow|900 mg|"Three, 300 mg Risperidone Implants~Risperidone Implant"
11360277|NCT02658357|OG000|Outcome|600 mg|"Two, 300 mg Risperidone Implants~Risperidone Implant"
11360278|NCT02658357|OG001|Outcome|900 mg|"Three, 300 mg Risperidone Implants~Risperidone Implant"
11360279|NCT02658357|EG000|Reported Event|600 mg|"Two, 300 mg Risperidone Implants~Risperidone Implant"
11360280|NCT02658357|EG001|Reported Event|900 mg|"Three, 300 mg Risperidone Implants~Risperidone Implant"
11360281|NCT02665988|BG000|Baseline|Real tDCS|"Those receiving experimental treatment will receive real tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.~tDCS: Prior to initiating the real tDCS trial and to reduce the likelihood of irritation associated with electrical stimulation, a low dose (1/8 of an inch) topical lidocaine (4%) cream will be applied to the skin where the tDCS the sponge-coated, surface electrodes soaked in saline solution will be placed. Neurotargeting tDCS-explorer software, Version 2.3 will be used to locate the left and right DLPFC, where anodal stimulation of the left DLPFC and cathodal stimulation of the right DLPFC will be received. Real tDCS will be applied during 20-minute periods over the course of 10 sessions. After each session, vitamin-E will be applied to the skin where the electrodes had been placed to reduce likelihood of skin irritation."
11360282|NCT02665988|BG001|Baseline|Sham tDCS|"Those receiving sham tDCS will receive active tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.~Sham tDCS: Participants randomized to sham tDCS will undergo the same procedures as those in the real tDCS sample, including the same pre-treatment lidocaine 4% cream, localization of electrode placement, actual placement of electrodes, turning on the tDCS device in sham setting but will not receive actual stimulation during the 20 minutes of each session, as well as post-treatment vitamin E."
11360283|NCT02665988|BG002|Baseline|Total|Total of all reporting groups
11360284|NCT02665988|FG000|Participant Flow|Real tDCS|"Those receiving experimental treatment will receive real tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.~tDCS: Prior to initiating the real tDCS trial and to reduce the likelihood of irritation associated with electrical stimulation, a low dose (1/8 of an inch) topical lidocaine (4%) cream will be applied to the skin where the tDCS the sponge-coated, surface electrodes soaked in saline solution will be placed. Neurotargeting tDCS-explorer software, Version 2.3 will be used to locate the left and right DLPFC, where anodal stimulation of the left DLPFC and cathodal stimulation of the right DLPFC will be received. Real tDCS will be applied during 20-minute periods over the course of 10 sessions. After each session, vitamin-E will be applied to the skin where the electrodes had been placed to reduce likelihood of skin irritation."
11360285|NCT02665988|FG001|Participant Flow|Sham tDCS|"Those receiving sham tDCS will receive active tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.~Sham tDCS: Participants randomized to sham tDCS will undergo the same procedures as those in the real tDCS sample, including the same pre-treatment lidocaine 4% cream, localization of electrode placement, actual placement of electrodes, turning on the tDCS device in sham setting but will not receive actual stimulation during the 20 minutes of each session, as well as post-treatment vitamin E."
11360286|NCT02665988|OG000|Outcome|Real tDCS|"Those receiving experimental treatment will receive real tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.~tDCS: Prior to initiating the real tDCS trial and to reduce the likelihood of irritation associated with electrical stimulation, a low dose (1/8 of an inch) topical lidocaine (4%) cream will be applied to the skin where the tDCS the sponge-coated, surface electrodes soaked in saline solution will be placed. Neurotargeting tDCS-explorer software, Version 2.3 will be used to locate the left and right DLPFC, where anodal stimulation of the left DLPFC and cathodal stimulation of the right DLPFC will be received. Real tDCS will be applied during 20-minute periods over the course of 10 sessions. After each session, vitamin-E will be applied to the skin where the electrodes had been placed to reduce likelihood of skin irritation."
11360287|NCT02665988|OG001|Outcome|Sham tDCS|"Those receiving sham tDCS will receive active tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.~Sham tDCS: Participants randomized to sham tDCS will undergo the same procedures as those in the real tDCS sample, including the same pre-treatment lidocaine 4% cream, localization of electrode placement, actual placement of electrodes, turning on the tDCS device in sham setting but will not receive actual stimulation during the 20 minutes of each session, as well as post-treatment vitamin E."
11360288|NCT02665988|EG000|Reported Event|Real tDCS|"Those receiving experimental treatment will receive real tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.~tDCS: Prior to initiating the real tDCS trial and to reduce the likelihood of irritation associated with electrical stimulation, a low dose (1/8 of an inch) topical lidocaine (4%) cream will be applied to the skin where the tDCS the sponge-coated, surface electrodes soaked in saline solution will be placed. Neurotargeting tDCS-explorer software, Version 2.3 will be used to locate the left and right DLPFC, where anodal stimulation of the left DLPFC and cathodal stimulation of the right DLPFC will be received. Real tDCS will be applied during 20-minute periods over the course of 10 sessions. After each session, vitamin-E will be applied to the skin where the electrodes had been placed to reduce likelihood of skin irritation."
10962090|NCT00864682|EG002|Reported Event|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
11360289|NCT02665988|EG001|Reported Event|Sham tDCS|"Those receiving sham tDCS will receive active tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.~Sham tDCS: Participants randomized to sham tDCS will undergo the same procedures as those in the real tDCS sample, including the same pre-treatment lidocaine 4% cream, localization of electrode placement, actual placement of electrodes, turning on the tDCS device in sham setting but will not receive actual stimulation during the 20 minutes of each session, as well as post-treatment vitamin E."
11360290|NCT02660528|BG000|Baseline|Baseline Demographics|Demographics of screened subjects.
11360291|NCT02660528|FG000|Participant Flow|Tocilizumab|"Tocilizumab 162 mg sc q2weeks x 4 doses~Tocilizumab: Subcutaneous tocilizumab"
11360292|NCT02660528|OG000|Outcome|Tocilizumab|"Tocilizumab 162 mg sc q2weeks x 4 doses~Tocilizumab: Subcutaneous tocilizumab"
11360293|NCT02660528|EG000|Reported Event|Tocilizumab|"Tocilizumab 162 mg sc q2weeks x 4 doses~Tocilizumab: Subcutaneous tocilizumab"
11360294|NCT02658877|BG000|Baseline|Omalizumab|Omalizumab: Omalizumab will be dosed according to dosing and U.S. administration guidelines for omalizumab. Omalizumab will be dosed every 2-4 weeks based on the patient's pre treatment serum IgE level (IU/mL) and initial visit body weight (kg). Omalizumab will be delivered as a subcutaneous injection. Standard safety precautions for dosing will be observed, including clinical observation after dosing, and provision of an epinephrine pen. Maintenance asthma treatment will remain unchanged.
11360295|NCT02658877|BG001|Baseline|Placebo|Placebo: Saline with a volume of injection frequency indicated based on the patient's serum IgE and body weight, delivered subcutaneously and supplied by Novartis Pharma.
11360296|NCT02658877|BG002|Baseline|Total|Total of all reporting groups
11360297|NCT02658877|FG000|Participant Flow|Omalizumab|Omalizumab: Omalizumab will be dosed according to dosing and U.S. administration guidelines for omalizumab. Omalizumab will be dosed every 2-4 weeks based on the patient's pre treatment serum IgE level (IU/mL) and initial visit body weight (kg). Omalizumab will be delivered as a subcutaneous injection. Standard safety precautions for dosing will be observed, including clinical observation after dosing, and provision of an epinephrine pen. Maintenance asthma treatment will remain unchanged.
11360298|NCT02658877|FG001|Participant Flow|Placebo|Placebo: Saline with a volume of injection frequency indicated based on the patient's serum IgE and body weight, delivered subcutaneously and supplied by Novartis Pharma.
11360299|NCT02658877|OG000|Outcome|Omalizumab|Omalizumab: Omalizumab will be dosed according to dosing and U.S. administration guidelines for omalizumab. Omalizumab will be dosed every 2-4 weeks based on the patient's pre treatment serum IgE level (IU/mL) and initial visit body weight (kg). Omalizumab will be delivered as a subcutaneous injection. Standard safety precautions for dosing will be observed, including clinical observation after dosing, and provision of an epinephrine pen. Maintenance asthma treatment will remain unchanged.
11360300|NCT02658877|OG001|Outcome|Placebo|Placebo: Saline with a volume of injection frequency indicated based on the patient's serum IgE and body weight, delivered subcutaneously and supplied by Novartis Pharma.
11360301|NCT02658877|EG000|Reported Event|Omalizumab|Omalizumab: Omalizumab will be dosed according to dosing and U.S. administration guidelines for omalizumab. Omalizumab will be dosed every 2-4 weeks based on the patient's pre treatment serum IgE level (IU/mL) and initial visit body weight (kg). Omalizumab will be delivered as a subcutaneous injection. Standard safety precautions for dosing will be observed, including clinical observation after dosing, and provision of an epinephrine pen. Maintenance asthma treatment will remain unchanged.
11360302|NCT02658877|EG001|Reported Event|Placebo|Placebo: Saline with a volume of injection frequency indicated based on the patient's serum IgE and body weight, delivered subcutaneously and supplied by Novartis Pharma.
11360303|NCT02654782|BG000|Baseline|Lactated Ringer's|"Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.~Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs."
11360304|NCT02654782|BG001|Baseline|5% Human Albumin|"Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.~5% Human Albumin: Colloid given for hemodynamic resuscitation based off of individual patient needs."
11360305|NCT02654782|BG002|Baseline|Total|Total of all reporting groups
11360306|NCT02654782|FG000|Participant Flow|Lactated Ringer's|"Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.~Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs."
11360307|NCT02654782|FG001|Participant Flow|5% Human Albumin|"Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.~5% Human Albumin: Colloid given for hemodynamic resuscitation based off of individual patient needs."
11360308|NCT02654782|OG000|Outcome|Lactated Ringer's|"Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.~Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs."
11360309|NCT02654782|OG001|Outcome|5% Human Albumin|"Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.~5% Human Albumin: Colloid given for hemodynamic resuscitation based off of individual patient needs."
11360310|NCT02654782|EG000|Reported Event|Lactated Ringer's|"Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.~Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs."
11360311|NCT02654782|EG001|Reported Event|5% Human Albumin|"Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.~5% Human Albumin: Colloid given for hemodynamic resuscitation based off of individual patient needs."
11360312|NCT02656199|BG000|Baseline|Main Cohort|"all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound~Diaphragm Ultrasound: Once on a pressure support weaning trial, enrolled subjects will have an ultrasound of their right hemidiaphragm performed on three levels of pressure support: 15/5 10/5 and 5/5~PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available."
11360313|NCT02656199|FG000|Participant Flow|Main Cohort|"all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound~Diaphragm Ultrasound: Once on a pressure support weaning trial, enrolled subjects will have an ultrasound of their right hemidiaphragm performed on three levels of pressure support: 15/5 10/5 and 5/5~0 participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.~PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available."
11360314|NCT02656199|OG000|Outcome|Main Cohort|"all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound~Diaphragm Ultrasound: Once on a pressure support weaning trial, enrolled subjects will have an ultrasound of their right hemidiaphragm performed on three levels of pressure support: 15/5 10/5 and 5/5~PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available."
11360315|NCT02656199|EG000|Reported Event|Main Cohort|"all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound~Diaphragm Ultrasound: Once on a pressure support weaning trial, enrolled subjects will have an ultrasound of their right hemidiaphragm performed on three levels of pressure support: 15/5 10/5 and 5/5~PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available."
11360316|NCT02654639|BG000|Baseline|TAS-102 and Bevacizumab|"Oral TAS-102 and intravenous Bevacizumab.~TAS-102: TAS-102 Twice a day by mouth day 1-5 and 8-12~Bevacizumab: Bevacizumab by intravenous infusion once every 14 days"
11360317|NCT02654639|FG000|Participant Flow|TAS-102 and Bevacizumab|"Oral TAS-102 and intravenous Bevacizumab.~TAS-102: TAS-102 Twice a day by mouth day 1-5 and 8-12~Bevacizumab: Bevacizumab by intravenous infusion once every 14 days"
11360318|NCT02654639|OG000|Outcome|TAS-102 and Bevacizumab|"Oral TAS-102 and intravenous Bevacizumab.~TAS-102: TAS-102 Twice a day by mouth day 1-5 and 8-12~Bevacizumab: Bevacizumab by intravenous infusion once every 14 days"
11360319|NCT02654639|EG000|Reported Event|TAS-102 and Bevacizumab|"Oral TAS-102 and intravenous Bevacizumab.~TAS-102: TAS-102 Twice a day by mouth day 1-5 and 8-12~Bevacizumab: Bevacizumab by intravenous infusion once every 14 days"
11360320|NCT02653495|BG000|Baseline|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11360321|NCT02653495|BG001|Baseline|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11360322|NCT02653495|BG002|Baseline|Total|Total of all reporting groups
11360323|NCT02653495|FG000|Participant Flow|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11360324|NCT02653495|FG001|Participant Flow|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11360325|NCT02653495|OG000|Outcome|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11360326|NCT02653495|OG001|Outcome|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11360327|NCT02653495|EG000|Reported Event|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11360328|NCT02653495|EG001|Reported Event|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11360329|NCT02640573|BG000|Baseline|Hydroxurea|"Initiate hydroxyurea at 10 mg/kg daily and escalate hydroxyurea dose by 5 mg/kg/day every 8 weeks up to a maximum dose of 35 mg/kg/day if blood counts meet escalation criteria.~Hydroxyurea: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the AdultsQLTM 3.0 Sickle Cell Disease Module after 6 months at MTD, compared to entrance scores"
11360330|NCT02640573|FG000|Participant Flow|Hydroxurea|"Initiate hydroxyurea at 10 mg/kg daily and escalate hydroxyurea dose by 5 mg/kg/day every 8 weeks up to a maximum dose of 35 mg/kg/day if blood counts meet escalation criteria.~Hydroxyurea: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the AdultsQLTM 3.0 Sickle Cell Disease Module after 6 months at MTD, compared to entrance scores"
11360331|NCT02640573|OG000|Outcome|Single Arm Study|adult patient on HU, measure of QoL
11360332|NCT02640573|EG000|Reported Event|Hydroxurea|"Initiate hydroxyurea at 10 mg/kg daily and escalate hydroxyurea dose by 5 mg/kg/day every 8 weeks up to a maximum dose of 35 mg/kg/day if blood counts meet escalation criteria.~Hydroxyurea: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the AdultsQLTM 3.0 Sickle Cell Disease Module after 6 months at MTD, compared to entrance scores"
11360333|NCT02639390|BG000|Baseline|Robotic|"The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist.~Robotic Therapy: Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.~Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement."
11360334|NCT02639390|BG001|Baseline|Conventional|"Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week).~Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement."
11360335|NCT02639390|BG002|Baseline|Total|Total of all reporting groups
11187588|NCT02107196|BG000|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
10962091|NCT00864708|BG000|Baseline|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
11187589|NCT02107196|BG001|Baseline|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
11187590|NCT02107196|BG002|Baseline|Total|Total of all reporting groups
11187591|NCT02107196|FG000|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the ibodutant 10 mg arm will be re-randomized at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
11187592|NCT02107196|FG001|Participant Flow|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the placebo arm will be mock-re-randomized (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
11187593|NCT02107196|OG000|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
11187594|NCT02107196|OG001|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
11187595|NCT02107196|EG000|Reported Event|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
11187596|NCT02107196|EG001|Reported Event|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
11187597|NCT02107274|BG000|Baseline|Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
11187598|NCT02107274|BG001|Baseline|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
11187599|NCT02107274|BG002|Baseline|Total|Total of all reporting groups
11187600|NCT02107274|FG000|Participant Flow|Azithromycin and Placebo for Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
11187601|NCT02107274|FG001|Participant Flow|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
11187602|NCT02107274|OG000|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
11187603|NCT02107274|OG001|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
11187604|NCT02107274|EG000|Reported Event|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
11187605|NCT02107274|EG001|Reported Event|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
11187606|NCT02107300|BG000|Baseline|NeutraSal|"NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.~NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse."
11187607|NCT02107300|BG001|Baseline|Placebo|"Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.~Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal"
11187608|NCT02107300|BG002|Baseline|Total|Total of all reporting groups
11187609|NCT02107300|FG000|Participant Flow|NeutraSal|"NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.~NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse."
11187610|NCT02107300|FG001|Participant Flow|Placebo|"Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.~Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal"
11187611|NCT02107300|OG000|Outcome|NeutraSal|"NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.~NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse."
11187612|NCT02107300|OG001|Outcome|Placebo|"Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.~Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal"
11187613|NCT02107300|EG000|Reported Event|NeutraSal|"NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.~NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse."
11187614|NCT02107300|EG001|Reported Event|Placebo|"Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.~Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal"
11187615|NCT02107313|BG000|Baseline|All Study Participants|Participants are first administered PBT2 250 mg orally following a period of fasting for 10 hours and a high fat breakfast in the FED cohort. Participants then cross over into the FASTED Cohort and receive PBT2 250 mg orally after a period of fasting of 10 hours and without food.
11187616|NCT02107313|FG000|Participant Flow|Fed Cohort First Then Fasted Cohort|"Per sequence, FED Cohort first then FASTED Cohort.~Nine participants in the FED Cohort. PBT2 250 mg is administered orally following a high fat breakfast first, following a period of fasting for 10 hours and a high fat breakfast. Participants then cross over into the FASTED Cohort."
11187617|NCT02107313|FG001|Participant Flow|Fasted Cohort First Then Fed Cohort|"Per sequence, FASTED Cohort first, then FED Cohort.~Nine participants in the Fasted Cohort. PBT2 250 mg is administered orally following a 10 hour period of fasting and without food first. Participants then cross over into the FED Cohort."
11187618|NCT02107313|OG000|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
11187619|NCT02107313|OG001|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
11187620|NCT02107313|EG000|Reported Event|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
11187621|NCT02107313|EG001|Reported Event|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
11187622|NCT02107339|BG000|Baseline|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
11187623|NCT02107339|BG001|Baseline|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
11187624|NCT02107339|BG002|Baseline|Total|Total of all reporting groups
11187625|NCT02107339|FG000|Participant Flow|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
11187626|NCT02107339|FG001|Participant Flow|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
11187627|NCT02107339|OG000|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
11187628|NCT02107339|OG001|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
11187629|NCT02107339|EG000|Reported Event|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
11187630|NCT02107339|EG001|Reported Event|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
11187631|NCT02107443|BG000|Baseline|Arm I (GA Informational Intervention)|"Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline.~Informational Intervention: Complete GA summary plus GA-driven recommendations"
11187632|NCT02107443|BG001|Baseline|Arm II (Usual Care)|Patients and their caregivers (if participating) complete the GA at baseline.
11187633|NCT02107443|BG002|Baseline|Total|Total of all reporting groups
11187634|NCT02107443|FG000|Participant Flow|Arm I (GA Informational Intervention)|"Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline.~Informational Intervention: Complete GA summary plus GA-driven recommendations"
11187635|NCT02107443|FG001|Participant Flow|Arm II (Usual Care)|Patients and their caregivers (if participating) complete the GA at baseline.
11187636|NCT02107443|OG000|Outcome|Arm I (GA Informational Intervention)|"Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline.~Informational Intervention:Complete GA summary plus GA-driven recommendations."
11187637|NCT02107443|OG001|Outcome|Arm II (Usual Care)|Patients and their caregivers (if participating) complete the GA at baseline.
11187638|NCT02107443|OG000|Outcome|Arm I (GA Informational Intervention)|"Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline.~Informational Intervention: Complete GA summary plus GA-driven recommendations"
11187639|NCT02107443|EG000|Reported Event|Arm I (GA Informational Intervention)|"Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline.~Informational Intervention: Complete GA summary plus GA-driven recommendations"
11187640|NCT02107443|EG001|Reported Event|Arm II (Usual Care)|Patients and their caregivers (if participating) complete the GA at baseline.
11187641|NCT02107482|BG000|Baseline|All Participants - Levia Narrow Band UVB|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
11187642|NCT02107482|FG000|Participant Flow|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
11187643|NCT02107482|OG000|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
11187644|NCT02107482|EG000|Reported Event|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
11187645|NCT02107599|BG000|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
11187646|NCT02107599|FG000|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
11187647|NCT02107599|OG000|Outcome|Physician Readers|All 21 physician readers.
11187648|NCT02107599|OG000|Outcome|All Study Cases|All 96 scans from A16 and A17.
11187649|NCT02107599|OG001|Outcome|Autopsy Cases|Only 46 autopsy scans from A16.
11187650|NCT02107599|OG002|Outcome|Non-autopsy Cases|Only 50 non-autopsy scans from A17.
11187651|NCT02107599|EG000|Reported Event|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
11187652|NCT02107703|BG000|Baseline|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187653|NCT02107703|BG001|Baseline|Placebo + Fulvestrant|Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187654|NCT02107703|BG002|Baseline|Total|Total of all reporting groups
11187655|NCT02107703|FG000|Participant Flow|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187656|NCT02107703|FG001|Participant Flow|Placebo + Fulvestrant|Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187657|NCT02107703|OG000|Outcome|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187658|NCT02107703|OG001|Outcome|Placebo + Fulvestrant|Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187659|NCT02107703|OG000|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187660|NCT02107703|OG001|Outcome|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187661|NCT02107703|OG000|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond.
11238756|NCT02465515|OG000|Outcome|Placebo|Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health.
11187662|NCT02107703|EG000|Reported Event|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187663|NCT02107703|EG001|Reported Event|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
11187664|NCT02107859|BG000|Baseline|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 192 weeks.
11187665|NCT02107859|FG000|Participant Flow|Ataluren|Participants received ataluren suspension orally 3 times a day (TID), 10 milligrams/kilogram (mg/kg) at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 192 weeks.
11187666|NCT02107859|OG000|Outcome|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 192 weeks.
11187667|NCT02107859|EG000|Reported Event|Ataluren|Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 192 weeks.
11187668|NCT02107898|BG000|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
11187669|NCT02107898|BG001|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11187670|NCT02107898|BG002|Baseline|Total|Total of all reporting groups
11187671|NCT02107898|FG000|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) added to stable lipid-modifying therapy (LMT) for 52 weeks.
11187672|NCT02107898|FG001|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11187673|NCT02107898|OG000|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
11187674|NCT02107898|OG001|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11187675|NCT02107898|EG000|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
11187676|NCT02107898|EG001|Reported Event|Alirocumab 75 mg/ Up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
11187677|NCT02108171|BG000|Baseline|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187678|NCT02108171|BG001|Baseline|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187679|NCT02108171|BG002|Baseline|Total|Total of all reporting groups
11187680|NCT02108171|FG000|Participant Flow|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187681|NCT02108171|FG001|Participant Flow|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187682|NCT02108171|OG000|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187683|NCT02108171|OG001|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187684|NCT02108171|OG000|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187685|NCT02108171|EG000|Reported Event|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187686|NCT02108171|EG001|Reported Event|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
11187687|NCT02108223|BG000|Baseline|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
11187688|NCT02108223|BG001|Baseline|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
11187689|NCT02108223|BG002|Baseline|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
11187690|NCT02108223|BG003|Baseline|Total|Total of all reporting groups
11360336|NCT02639390|FG000|Participant Flow|Robotic|"The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist.~Robotic Therapy: Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.~Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement."
11360337|NCT02639390|FG001|Participant Flow|Conventional|"Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week).~Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement."
11360338|NCT02639390|OG000|Outcome|Robotic|"The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist.~Robotic Therapy: Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.~Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement."
11360339|NCT02639390|OG001|Outcome|Conventional|"Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week).~Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement."
11360340|NCT02639390|EG000|Reported Event|Robotic|"The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist.~Robotic Therapy: Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.~Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement."
11360341|NCT02639390|EG001|Reported Event|Conventional|"Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week).~Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement."
11360342|NCT02634606|BG000|Baseline|Pre-Randomization|Thirteen enrolled subjects were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill). Randomization was not performed prior to study termination.
11360343|NCT02634606|FG000|Participant Flow|Pre-Randomization|Thirteen enrolled subjects were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill). Randomization was not performed prior to study termination.
11360344|NCT02634606|OG000|Outcome|Gamma Delta Tocotrienols - Low Dose|"33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (63mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.~Gamma Delta Tocotrienols - Low Dose: 250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks."
11360345|NCT02634606|OG001|Outcome|Gamma Delta Tocotrienols - High Dose|"33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (127mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.~Gamma Delta Tocotrienols - High Dose: 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks."
11360346|NCT02634606|OG002|Outcome|Sugar Pill|"33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the Placebo arm of the study to evaluate the cholesterol suppressive actions of Placebo. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.~Sugar Pill: 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks."
10962092|NCT00864708|FG000|Participant Flow|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
11187691|NCT02108223|FG000|Participant Flow|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
10962093|NCT00864708|OG000|Outcome|Arm 1|gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
10962094|NCT00864708|OG000|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
11187692|NCT02108223|FG001|Participant Flow|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
11187693|NCT02108223|FG002|Participant Flow|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
11187694|NCT02108223|OG000|Outcome|Fix Dose r-FSH (Gonal-f) Group 1|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
11187695|NCT02108223|OG001|Outcome|r-LH Supplementation to r-FSH Group 2|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
11187696|NCT02108223|OG002|Outcome|r-FSH (Gonal-f) Group 3|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
11187697|NCT02108223|OG000|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
11187698|NCT02108223|OG001|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
11187699|NCT02108223|OG002|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
11187700|NCT02108223|EG000|Reported Event|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
11187701|NCT02108223|EG001|Reported Event|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
11187702|NCT02108223|EG002|Reported Event|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
11187703|NCT02108262|BG000|Baseline|Safety Lead-in [CSL112 (2 g)]|In the safety lead-in, a small number of subjects (evenly stratified between subjects with normal renal function or mild renal impairment) were administered a single, 2 g infusion of CSL112.
11187704|NCT02108262|BG001|Baseline|CSL112 (2 g)|"CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.~CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11187705|NCT02108262|BG002|Baseline|CSL112 (6 g)|"CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks.~CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11187706|NCT02108262|BG003|Baseline|Placebo|"Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion.~Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)"
11187707|NCT02108262|BG004|Baseline|Total|Total of all reporting groups
11187708|NCT02108262|FG000|Participant Flow|Safety Lead-in [CSL112 (2 g)]|In the safety lead-in, a small number of subjects (evenly stratified between subjects with normal renal function or mild renal impairment) were administered a single, 2 g infusion of CSL112.
11187709|NCT02108262|FG001|Participant Flow|CSL112 (2 g)|"CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.~CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11187710|NCT02108262|FG002|Participant Flow|CSL112 (6 g)|"CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks.~CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11187711|NCT02108262|FG003|Participant Flow|Placebo|"Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion.~Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)"
11360347|NCT02634606|EG000|Reported Event|Gamma Delta Tocotrienols - Low Dose|"33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (63mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.~Gamma Delta Tocotrienols - Low Dose: 250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks."
11360348|NCT02634606|EG001|Reported Event|Gamma Delta Tocotrienols - High Dose|"33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (127mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.~Gamma Delta Tocotrienols - High Dose: 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks."
11360349|NCT02634606|EG002|Reported Event|Sugar Pill|"33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the Placebo arm of the study to evaluate the cholesterol suppressive actions of Placebo. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.~Sugar Pill: 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks."
11360350|NCT02634827|BG000|Baseline|Treatment (Decitabine, Midostaurin)|Patients receive decitabine intravenously (IV) over 1 hour on days 1-5 and midostaurin orally (PO) twice daily (BID) on days 8-21 of courses 1 and 2, and on days 1-28 of each subsequent course. Patients failing to achieve complete response (CR)/complete response with incomplete recovery (CRi)/partial response (PR)/morphologic leukemia-free state by end of course 2 receive midostaurin PO BID on days 1-28. Patients achieving CR/CRi/PR/morphologic leukemia-free state by end of course 8 may continue on current regimen. Patients failing to achieve a CR/CRi/PR/ morphologic leukemia-free state in bone marrow blasts by end of course 8 go to event monitoring. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11360351|NCT02634827|FG000|Participant Flow|Treatment (Decitabine, Midostaurin)|Patients receive decitabine intravenously (IV) over 1 hour on days 1-5 and midostaurin orally (PO) twice daily (BID) on days 8-21 of courses 1 and 2, and on days 1-28 of each subsequent course. Patients failing to achieve complete response (CR)/complete response with incomplete recovery (CRi)/partial response (PR)/morphologic leukemia-free state by end of course 2 receive midostaurin PO BID on days 1-28. Patients achieving CR/CRi/PR/morphologic leukemia-free state by end of course 8 may continue on current regimen. Patients failing to achieve a CR/CRi/PR/ morphologic leukemia-free state in bone marrow blasts by end of course 8 go to event monitoring. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11360352|NCT02634827|OG000|Outcome|Treatment (Decitabine, Midostaurin)|Patients receive decitabine intravenously (IV) over 1 hour on days 1-5 and midostaurin orally (PO) twice daily (BID) on days 8-21 of courses 1 and 2, and on days 1-28 of each subsequent course. Patients failing to achieve complete response (CR)/complete response with incomplete recovery (CRi)/partial response (PR)/morphologic leukemia-free state by end of course 2 receive midostaurin PO BID on days 1-28. Patients achieving CR/CRi/PR/morphologic leukemia-free state by end of course 8 may continue on current regimen. Patients failing to achieve a CR/CRi/PR/ morphologic leukemia-free state in bone marrow blasts by end of course 8 go to event monitoring. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11360353|NCT02634827|EG000|Reported Event|Treatment (Decitabine, Midostaurin)|Patients receive decitabine intravenously (IV) over 1 hour on days 1-5 and midostaurin orally (PO) twice daily (BID) on days 8-21 of courses 1 and 2, and on days 1-28 of each subsequent course. Patients failing to achieve complete response (CR)/complete response with incomplete recovery (CRi)/partial response (PR)/morphologic leukemia-free state by end of course 2 receive midostaurin PO BID on days 1-28. Patients achieving CR/CRi/PR/morphologic leukemia-free state by end of course 8 may continue on current regimen. Patients failing to achieve a CR/CRi/PR/ morphologic leukemia-free state in bone marrow blasts by end of course 8 go to event monitoring. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11360354|NCT02636283|BG000|Baseline|Entresto|"oral route~Entresto: Oral pills"
11360355|NCT02636283|BG001|Baseline|Placebo Group|"Oral placebo~Placebo group: The placebo pills"
11360356|NCT02636283|BG002|Baseline|Total|Total of all reporting groups
10962095|NCT00864708|OG000|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
10962096|NCT00864708|EG000|Reported Event|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
11360357|NCT02636283|FG000|Participant Flow|Entresto|"oral route~Entresto: Oral pills"
11360358|NCT02636283|FG001|Participant Flow|Placebo Group|"Oral placebo~Placebo group: The placebo pills"
11360359|NCT02636283|OG000|Outcome|Entresto|"oral route~Entresto: Oral pills"
11360360|NCT02636283|OG001|Outcome|Placebo Group|"Oral placebo~Placebo group: The placebo pills"
11360361|NCT02636283|EG000|Reported Event|Entresto|"oral route~Entresto: Oral pills"
11360362|NCT02636283|EG001|Reported Event|Placebo Group|"Oral placebo~Placebo group: The placebo pills"
11360363|NCT02638129|BG000|Baseline|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
11360364|NCT02638129|BG001|Baseline|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
11360365|NCT02638129|BG002|Baseline|Total|Total of all reporting groups
11360366|NCT02638129|FG000|Participant Flow|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
11360367|NCT02638129|FG001|Participant Flow|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
11360368|NCT02638129|OG000|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
11360369|NCT02638129|OG001|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
11360370|NCT02638129|EG000|Reported Event|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
11360371|NCT02638129|EG001|Reported Event|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
11360372|NCT02615990|BG000|Baseline|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
11360373|NCT02615990|BG001|Baseline|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
11360374|NCT02615990|BG002|Baseline|Total|Total of all reporting groups
11360375|NCT02615990|FG000|Participant Flow|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
11360376|NCT02615990|FG001|Participant Flow|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
11360377|NCT02615990|OG000|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
11360378|NCT02615990|OG001|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
10962097|NCT00864721|BG000|Baseline|Sunitinib Malate|"Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.~Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle."
11360379|NCT02615990|EG000|Reported Event|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
11360380|NCT02615990|EG001|Reported Event|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
11360381|NCT02640677|BG000|Baseline|Pregnant Women Exposed to 4CMenB|Pregnant women within the United States (US) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy
11360382|NCT02640677|FG000|Participant Flow|Pregnant Women Exposed to 4CMenB|Pregnant women within the United States (US) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy
11360383|NCT02640677|OG000|Outcome|Pregnant Women Exposed to 4CMenB|Pregnant women within the United States (US) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy
11360384|NCT02640677|EG000|Reported Event|Pregnant Women Exposed to 4CMenB|Pregnant women within the United States (US) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy
11360385|NCT02633540|BG000|Baseline|IMRT Radiation|"All subjects will be treated using IMRT with the standard fractionation for T1a glottic cancer at Fox Chase Cancer Center: 63 Gy in 28 fractions; 6 for T1a and 65.25 Gy in 29 fractions; 33 for T2a. Treatment will be followed by functional assessments performed at months 1,3,6,12,and 24.~IMRT Radiation: Radiation to Larynx"
11360386|NCT02633540|FG000|Participant Flow|IMRT Radiation|"All subjects will be treated using IMRT with the standard fractionation for T1a glottic cancer at Fox Chase Cancer Center: 63 Gy in 28 fractions; 6 for T1a and 65.25 Gy in 29 fractions; 33 for T2a. Treatment will be followed by functional assessments performed at months 1,3,6,12,and 24.~IMRT Radiation: Radiation to Larynx"
11360387|NCT02633540|OG000|Outcome|IMRT Radiation|"All subjects will be treated using IMRT with the standard fractionation for T1a glottic cancer at Fox Chase Cancer Center: 63 Gy in 28 fractions; 6 for T1a and 65.25 Gy in 29 fractions; 33 for T2a. Treatment will be followed by functional assessments performed at months 1,3,6,12,and 24.~IMRT Radiation: Radiation to Larynx"
11360388|NCT02633540|EG000|Reported Event|IMRT Radiation|"All subjects will be treated using IMRT with the standard fractionation for T1a glottic cancer at Fox Chase Cancer Center: 63 Gy in 28 fractions; 6 for T1a and 65.25 Gy in 29 fractions; 33 for T2a. Treatment will be followed by functional assessments performed at months 1,3,6,12,and 24.~IMRT Radiation: Radiation to Larynx"
11360389|NCT02623959|BG000|Baseline|Indwelling Pleural Catheters (IPC) (Randomized to Saline)|"Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter. After the IPC is removed, participant is called one time each month by study staff to check on their status. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.~Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.~Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.~Saline: Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.~Phone Calls: After the IPC is removed, partici"
11360390|NCT02623959|BG001|Baseline|IPC Plus Doxycycline (Randomized to Rx Arm)|"Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.~After the IPC is removed, participant is called one time each month by study staff to check on their status. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.~Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.~Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.~Doxycycline: Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.~Phone Calls: After th"
11360391|NCT02623959|BG002|Baseline|Total|Total of all reporting groups
11360392|NCT02623959|FG000|Participant Flow|Indwelling Pleural Catheters (Randomized to Saline)|"On Day 5, Fentanyl patch 12 mcg/hr placed if not already on, Fentanyl 50 mcg IV given, drain maximally, saline instilled, catheter capped for 1 hour and then re-drain. Pain will assess using a Visual Analogue Scale (VAS) as well, patient discharged home.~Symptom and quality of life questionnaires will be completed at baseline, at 10 - 14 days and each month for 12 months as well as recurrence status defined as recurrent effusion on the same side requiring intervention will be documented."
11360393|NCT02623959|FG001|Participant Flow|Indwelling Pleural Catheters+Doxycycline (Randomized to Rx Arm|"On Day 5, Fentanyl patch 12 mcg/hr placed if not already on, Fentanyl 50 mcg IV given, drain maximally, doxycycline instilled, Catheter is capped for 1 hour and then re-drain. Pain will assess using a Visual Analogue Scale as well, patient discharged home.~Symptom and quality of life questionnaires will be completed at baseline, at 10 - 14 days and each month for 12 months as well as recurrence status defined as recurrent effusion on the same side requiring intervention will be documented."
11360394|NCT02623959|OG000|Outcome|Indwelling Pleural Catheter (IPC) + Saline|"Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter.~After the IPC is removed, participant is called one time each month by study staff to check on their status.~Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.~Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.~Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining. Saline: Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.~Phone Calls: After the IPC is removed, partici"
11360395|NCT02623959|OG001|Outcome|Indwelling Pleural Catheter (IPC) + Doxycycline|"Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.~After the IPC is removed, participant is called one time each month by study staff to check on their status Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.~Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.~Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining. Doxycycline: Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.~Phone Calls: After th"
11360396|NCT02623959|OG000|Outcome|Indwelling Pleural Catheters (Randomized to Saline)|"Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter. After the IPC is removed, participant is called one time each month by study staff to check on their status. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.~Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.~Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.~Saline: Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.~Phone Calls: After the IPC is removed, partici"
11360397|NCT02623959|OG001|Outcome|Indwelling Pleural Catheters Plus Doxycycline (Randomized to R|"Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.~After the IPC is removed, participant is called one time each month by study staff to check on their status. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.~Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.~Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.~Doxycycline: Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.~Phone Calls: After th"
11360398|NCT02623959|EG000|Reported Event|Indwelling Pleural Catheters (Randomized to Saline)|"Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter. After the IPC is removed, participant is called one time each month by study staff to check on their status. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.~Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.~Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.~Saline: Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.~Phone Calls: After the IPC is removed, partici"
11360399|NCT02623959|EG001|Reported Event|Indwelling Pleural Catheters Plus Doxycycline (Randomized to R|"Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.~After the IPC is removed, participant is called one time each month by study staff to check on their status. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.~Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.~Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.~Doxycycline: Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.~Phone Calls: After th"
11360400|NCT02631148|BG000|Baseline|Melatonin|"Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks~Melatonin: 2mg controlled release melatonin tablet"
11360401|NCT02631148|BG001|Baseline|Placebo|"Placebo tablet identical to Circadin by mouth each day before bedtime for 6 weeks~Placebo: placebo tablet identical to circadin"
11360402|NCT02631148|BG002|Baseline|Total|Total of all reporting groups
11360403|NCT02631148|FG000|Participant Flow|Melatonin|"Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks~Melatonin: 2mg controlled release melatonin tablet"
11360404|NCT02631148|FG001|Participant Flow|Placebo|"Placebo tablet identical to Circadin by mouth each day before bedtime for 6 weeks~Placebo: placebo tablet identical to circadin"
11360405|NCT02631148|OG000|Outcome|Melatonin|"Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks~Melatonin: 2mg controlled release melatonin tablet"
11360406|NCT02631148|OG001|Outcome|Placebo|"Placebo tablet identical to Circadin by mouth each day before bedtime for 6 weeks~Placebo: placebo tablet identical to circadin"
11360407|NCT02631148|EG000|Reported Event|Melatonin|"Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks~Melatonin: 2mg controlled release melatonin tablet"
11360408|NCT02631148|EG001|Reported Event|Placebo|"Placebo tablet identical to Circadin by mouth each day before bedtime for 6 weeks~Placebo: placebo tablet identical to circadin"
11360409|NCT02630472|BG000|Baseline|Quinine Sulfate|"Each participant in the experimental arm will receive 28 tubes with 1mg/ml (6 mls total) of quinine sulfate, as well as 28 3cc syringes with the atomizers. The solutions will be light-protected. Patients will apply 3 mls to each nostril twice per day. Patients will be exposed to 12.0 mg quinine per day.~The Investigational Drug Service (IDS) will prepare and record the distribution of the irrigant. The Clinical Research Coordinator or Clinical Research Nurse will pick up the solutions and will demonstrate the application. The application of the solution is exactly the same as their daily regimen.~Quinine Sulfate: Our plan is to first determine efficacy and safety. The patients will be exposed to a maximum of 12mls or 12.0 mg of quinine. Thus, the maximum systemic exposure in our study (assuming ingestion of the total nasal administration) is less than drinking one glass of tonic water / day. The therapeutic range of quinine to treat malaria is nearly 200 X the dose proposed."
11360410|NCT02630472|BG001|Baseline|Placebo|"The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.~Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be in light-protected tubes.~The placebo arm will mirror the experimental arm exactly, except for the treatment solution contained in the vials.~Placebo: In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a placebo."
11360411|NCT02630472|BG002|Baseline|Total|Total of all reporting groups
11360412|NCT02630472|FG000|Participant Flow|Quinine Sulfate|"Each study participant randomized into the experimental arm will receive 28 tubes with 1mg/ml (6 mls) of quinine sulfate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes. Patients will apply 3 mls of quinine sulfate to each nostril twice per day. Thus the patients will be exposed to a maximum of 12mls or 12.0 mg of quinine per day.~The Investigational Drug Service (IDS) will prepare and record the distribution of the irrigant. The Clinical Research Coordinator or Clinical Research Nurse will pick up the solutions and will demonstrate the application to the subject. The application of the solution is exactly the same as if the study subject were to irrigate with regular saline as part of their daily regimen for chronic rhinosinusitis.~Quinine Sulfate: Our plan is to first study quinine against saline to determine efficacy and safety. The vast majority of patients with rhinosinusitis utilize low pressure"
11360413|NCT02630472|FG001|Participant Flow|Placebo|"The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.~Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the atomizing devices. The solutions will be supplied in light-protected tubes.~The placebo arm will mirror the experimental arm exactly, except for the treatment solution contained in the vials.~Placebo: In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a plac"
11360414|NCT02630472|OG000|Outcome|Quinine Sulfate|Each study participant randomized into the experimental arm will receive 28 tubes with 1mg/ml (6 mls total) of quinine sulfate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes. Patients will apply 3 mls of quinine sulfate to each nostril twice per day. Thus the patients will be exposed to a maximum of 12mls or 12.0 mg of quinine per day.
11360415|NCT02630472|OG001|Outcome|Placebo|"The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.~Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes.~Placebo: In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a placebo."
11360416|NCT02630472|OG001|Outcome|Placebo|"The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.~Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes.~The placebo arm will mirror the experimental arm exactly, except for the treatment solution contained in the vials."
11360417|NCT02630472|EG000|Reported Event|Quinine Sulfate|Each study participant randomized into the experimental arm will receive 28 tubes with 1mg/ml (6 mls total) of quinine sulfate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes. Patients will apply 3 mls of quinine sulfate to each nostril twice per day. Thus the patients will be exposed to a maximum of 12mls or 12.0 mg of quinine per day.
11360418|NCT02630472|EG001|Reported Event|Placebo|"The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.~Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes.~Placebo: In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a placebo."
11360419|NCT02626520|BG000|Baseline|Resectable, Low Risk|"Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.~Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles~Definitive resection: Definitive surgical resection of primary tumor"
11360420|NCT02626520|BG001|Baseline|Locally Advanced|"Systemic chemotherapy followed by chemoradiation, followed by definitive surgery~Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles~5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles~Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions~Definitive resection: Definitive surgical resection of primary tumor"
11360421|NCT02626520|BG002|Baseline|Total|Total of all reporting groups
11360422|NCT02626520|FG000|Participant Flow|Resectable, Low Risk|"Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.~Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles~Definitive resection: Definitive surgical resection of primary tumor"
11360423|NCT02626520|FG001|Participant Flow|Locally Advanced|"Systemic chemotherapy followed by chemoradiation, followed by definitive surgery~Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles~5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles~Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions~Definitive resection: Definitive surgical resection of primary tumor"
11360424|NCT02626520|OG000|Outcome|Resectable, Low Risk|"Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.~Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles~Definitive resection: Definitive surgical resection of primary tumor"
11360425|NCT02626520|OG001|Outcome|Locally Advanced|"Systemic chemotherapy followed by chemoradiation, followed by definitive surgery~Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles~5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles~Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions~Definitive resection: Definitive surgical resection of primary tumor"
11360426|NCT02626520|EG000|Reported Event|Resectable, Low Risk|"Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.~Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles~Definitive resection: Definitive surgical resection of primary tumor"
11360427|NCT02626520|EG001|Reported Event|Locally Advanced|"Systemic chemotherapy followed by chemoradiation, followed by definitive surgery~Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles~5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles~Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions~Definitive resection: Definitive surgical resection of primary tumor"
11360428|NCT02614898|BG000|Baseline|Pediatric|Participants with aHUS who were less than 18 years at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician.
11360429|NCT02614898|BG001|Baseline|Adult|Participants with aHUS who were 18 years or older at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician.
11360430|NCT02614898|BG002|Baseline|Total|Total of all reporting groups
11360431|NCT02614898|FG000|Participant Flow|Pediatric|Participants with atypical hemolytic uremic syndrome (aHUS) who were less than 18 years at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician.
11360432|NCT02614898|FG001|Participant Flow|Adult|Participants with aHUS who were 18 years or older at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician.
11360433|NCT02614898|OG000|Outcome|Pediatric|Participants with aHUS who were less than 18 years at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician.
11360434|NCT02614898|OG001|Outcome|Adult|Participants with aHUS who were 18 years or older at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician.
11360435|NCT02614898|OG001|Outcome|Adult|Participants with aHUS who were 18 years or older at baseline and who were treated with eculizumab. Dosing regimen changed solely at the discretion of the treating physician.
11360436|NCT02614898|EG000|Reported Event|Pediatric|Participants with aHUS who were less than 18 years at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician.
11360437|NCT02614898|EG001|Reported Event|Adult|Participants with aHUS who were 18 years or older at baseline and who initiated treatment with eculizumab prior to study entry. Dosing regimen changed solely at the discretion of the treating physician.
11360438|NCT02622828|BG000|Baseline|Behavioural|"Participant-identified community based activity~Participant-identified community based activity: The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals."
11360439|NCT02622828|FG000|Participant Flow|Behavioural|"Participant-identified community based activity~Participant-identified community based activity: The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals."
11360440|NCT02622828|OG000|Outcome|Behavioural|"Participant-identified community based activity~Participant-identified community based activity: The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals."
11360441|NCT02622828|EG000|Reported Event|Behavioural|"Participant-identified community based activity~Participant-identified community based activity: The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals."
11360442|NCT02624739|BG000|Baseline|Intervention|"Reassure Non-Contact Respiration Monitor: Respiration parameters transmitted by the Reassure device will be evaluated daily by the study team and participants will be contacted for further evaluation if a change in respiration patterns is noted. Participants will continue with standard of care heart failure treatment.~Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep."
11360443|NCT02624739|BG001|Baseline|Control|"Reassure Non-Contact Respiration Monitor: Respiration parameters will be transmitted and stored, but there will be no active evaluation of respiration patterns. Participants will continue with standard of care heart failure treatment.~Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep."
11360444|NCT02624739|BG002|Baseline|Total|Total of all reporting groups
11360445|NCT02624739|FG000|Participant Flow|Intervention|"Reassure Non-Contact Respiration Monitor: Respiration parameters transmitted by the Reassure device will be evaluated daily by the study team and participants will be contacted for further evaluation if a change in respiration patterns is noted. Participants will continue with standard of care heart failure treatment.~Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep."
11360446|NCT02624739|FG001|Participant Flow|Control|"Reassure Non-Contact Respiration Monitor: Respiration parameters will be transmitted and stored, but there will be no active evaluation of respiration patterns. Participants will continue with standard of care heart failure treatment.~Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep."
11360447|NCT02624739|OG000|Outcome|Intervention|"Reassure Non-Contact Respiration Monitor: Respiration parameters transmitted by the Reassure device will be evaluated daily by the study team and participants will be contacted for further evaluation if a change in respiration patterns is noted. Participants will continue with standard of care heart failure treatment.~Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep."
11360448|NCT02624739|OG001|Outcome|Control|"Reassure Non-Contact Respiration Monitor: Respiration parameters will be transmitted and stored, but there will be no active evaluation of respiration patterns. Participants will continue with standard of care heart failure treatment.~Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep."
11360449|NCT02624739|EG000|Reported Event|Intervention|"Reassure Non-Contact Respiration Monitor: Respiration parameters transmitted by the Reassure device will be evaluated daily by the study team and participants will be contacted for further evaluation if a change in respiration patterns is noted. Participants will continue with standard of care heart failure treatment.~Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep."
10962098|NCT00864721|FG000|Participant Flow|Sunitinib Malate|"Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.~Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle."
11360450|NCT02624739|EG001|Reported Event|Control|"Reassure Non-Contact Respiration Monitor: Respiration parameters will be transmitted and stored, but there will be no active evaluation of respiration patterns. Participants will continue with standard of care heart failure treatment.~Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep."
11238757|NCT02465515|OG001|Outcome|Albiglutide|Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health.
11238758|NCT02465515|EG000|Reported Event|Albiglutide|Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health..
11238759|NCT02465515|EG001|Reported Event|Placebo|Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health.
11238760|NCT02465528|BG000|Baseline|Anaplastic Large Cell Lymphoma (ALCL)|Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
11238761|NCT02465528|BG001|Baseline|Inflammatory Myofibroblastic Tumor (IMT)|Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
11238762|NCT02465528|BG002|Baseline|Glioblastoma (GBM)|Patients with GBM with a translocation involving the ALK gene
11238763|NCT02465528|BG003|Baseline|Any Other ALK-positive Tumor|Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
11238764|NCT02465528|BG004|Baseline|Total|Total of all reporting groups
11238765|NCT02465528|FG000|Participant Flow|Anaplastic Large Cell Lymphoma (ALCL)|Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
11238766|NCT02465528|FG001|Participant Flow|Inflammatory Myofibroblastic Tumor (IMT)|Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
11238767|NCT02465528|FG002|Participant Flow|Glioblastoma (GBM)|Patients with GBM with a translocation involving the ALK gene
11238768|NCT02465528|FG003|Participant Flow|Any Other ALK-positive Tumor|Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
11238769|NCT02465528|OG000|Outcome|Anaplastic Large Cell Lymphoma (ALCL)|Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
11238770|NCT02465528|OG001|Outcome|Inflammatory Myofibroblastic Tumor (IMT)|Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
11238771|NCT02465528|OG002|Outcome|Glioblastoma (GBM)|Patients with GBM with a translocation involving the ALK gene
11238772|NCT02465528|OG003|Outcome|Any Other ALK-positive Tumor|Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
11238773|NCT02465528|OG002|Outcome|Glioblastomia (GBM)|Patients with GBM with a translocation involving the ALK gene
11238774|NCT02465528|EG000|Reported Event|Anaplastic Large Cell Lymphoma|Anaplastic Large Cell Lymphoma
11238775|NCT02465528|EG001|Reported Event|Inflammatory Myofibroblastic Tumor|Inflammatory Myofibroblastic Tumor
11238776|NCT02465528|EG002|Reported Event|Glioblastoma|Glioblastoma
11238777|NCT02465528|EG003|Reported Event|Any Other ALK+ Tumor|Any other ALK+ tumor
11238778|NCT02465528|EG004|Reported Event|All Subjects|All Subjects
11238779|NCT02465567|BG000|Baseline|BGF MDI 320/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg
11238780|NCT02465567|BG001|Baseline|BGF MDI 160/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg
11238781|NCT02465567|BG002|Baseline|GFF MDI 14.4/9.6 μg|Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg
11238782|NCT02465567|BG003|Baseline|BFF MDI 320/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
11238783|NCT02465567|BG004|Baseline|Total|Total of all reporting groups
11238784|NCT02465567|FG000|Participant Flow|BGF MDI 320/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg
11238785|NCT02465567|FG001|Participant Flow|BGF MDI 160/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg
11238786|NCT02465567|FG002|Participant Flow|GFF MDI 14.4/9.6 μg|Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg
11238787|NCT02465567|FG003|Participant Flow|BFF MDI 320/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
11238788|NCT02465567|OG000|Outcome|BGF MDI 320/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg
11238789|NCT02465567|OG001|Outcome|BGF MDI 160/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg
11238790|NCT02465567|OG002|Outcome|GFF MDI 14.4/9.6 μg|Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg
11238791|NCT02465567|OG003|Outcome|BFF MDI 320/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
11238792|NCT02465567|EG000|Reported Event|BGF MDI 320/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg
11238793|NCT02465567|EG001|Reported Event|BGF MDI 160/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg
11238794|NCT02465567|EG002|Reported Event|GFF MDI 14.4/9.6 μg|Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg
11238795|NCT02465567|EG003|Reported Event|BFF MDI 320/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
11238796|NCT02465632|BG000|Baseline|Test|Test: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
11238797|NCT02465632|BG001|Baseline|Reference|Reference: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
11238798|NCT02465632|BG002|Baseline|Placebo|Placebo: Placebo topical gel
11238799|NCT02465632|BG003|Baseline|Total|Total of all reporting groups
11238800|NCT02465632|FG000|Participant Flow|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel|Test: A thin layer of gel was applied to the entire affected areas on the face twice a day.
11238801|NCT02465632|FG001|Participant Flow|BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%|Reference: A thin layer of gel was applied to the entire affected areas on the face twice a day.
11187712|NCT02108262|OG000|Outcome|CSL112 (2 g)|"CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.~CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11187713|NCT02108262|OG001|Outcome|CSL112 (6 g)|"CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks.~CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11187714|NCT02108262|OG002|Outcome|Placebo|"Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion.~Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)"
11187715|NCT02108262|EG000|Reported Event|Safety Lead-in [CSL112 (2 g)]|In the safety lead-in, a small number of subjects (evenly stratified between subjects with normal renal function or mild renal impairment) were administered a single, 2 g infusion of CSL112.
11187716|NCT02108262|EG001|Reported Event|CSL112 (2 g)|CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.
11187717|NCT02108262|EG002|Reported Event|CSL112 (6 g)|CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks.
11187718|NCT02108262|EG003|Reported Event|Placebo|Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion.
11187719|NCT02108288|BG000|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187720|NCT02108288|BG001|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
11187721|NCT02108288|BG002|Baseline|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
11187722|NCT02108288|BG003|Baseline|Total|Total of all reporting groups
11187723|NCT02108288|FG000|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187724|NCT02108288|FG001|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
11187725|NCT02108288|FG002|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
11187726|NCT02108288|OG000|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187727|NCT02108288|OG001|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
11187728|NCT02108288|OG001|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
11187729|NCT02108288|EG000|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
11187730|NCT02108288|EG001|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
11187731|NCT02108288|EG002|Reported Event|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
11187732|NCT02108457|BG000|Baseline|Proton Subjects|[18F]Fluorothymidine (FLT) PET/CT Imaging
11187733|NCT02108457|BG001|Baseline|IMRT Subjects|[18F]Fluorothymidine (FLT) PET/CT Imaging
11187734|NCT02108457|BG002|Baseline|Total|Total of all reporting groups
11187735|NCT02108457|FG000|Participant Flow|Proton Subjects|[18F]Fluorothymidine (FLT) PET/CT Imaging
11187736|NCT02108457|FG001|Participant Flow|IMRT Subjects|[18F]Fluorothymidine (FLT) PET/CT Imaging
11187737|NCT02108457|OG000|Outcome|Proton Subjects|[18F]Fluorothymidine (FLT) PET/CT Imaging
11187738|NCT02108457|OG001|Outcome|IMRT Subjects|[18F]Fluorothymidine (FLT) PET/CT Imaging
11187739|NCT02108457|EG000|Reported Event|Proton Subjects|[18F]Fluorothymidine (FLT) PET/CT Imaging
11187740|NCT02108457|EG001|Reported Event|IMRT Subjects|[18F]Fluorothymidine (FLT) PET/CT Imaging
11187741|NCT02108522|BG000|Baseline|Multivirus Specific T Cells|"Partially HLA-matched multivirus specific T cells (VSTs) will be thawed and given by intravenous injection. Patients will receive 2 x 10^7 VSTs/m2 as a single infusion. In the rare case where insufficient banked cell product is available, a lower number of cells may be infused after discussion with the principal investigator, patient and/or guardian and the treatment team.~If after the first treatment there is persistent infection, there is an option to receive more treatments. These additional treatments might be with cells from the same donor or another donor whose cells are also thought to be a good match for the patient and effective against their virus. This second product will be administered at the same dose level 28 days after the initial infusion, and subsequent infusions should be at least 14 days apart."
11187742|NCT02108522|FG000|Participant Flow|Multivirus Specific T Cells|"Partially HLA-matched multivirus specific T cells (VSTs) will be thawed and given by intravenous injection. Patients will receive 2 x 10^7 VSTs/m2 as a single infusion. In the rare case where insufficient banked cell product is available, a lower number of cells may be infused after discussion with the principal investigator, patient and/or guardian and the treatment team.~If after the first treatment there is persistent infection, there is an option to receive more treatments. These additional treatments might be with cells from the same donor or another donor whose cells are also thought to be a good match for the patient and effective against their virus. This second product will be administered at the same dose level 28 days after the initial infusion, and subsequent infusions should be at least 14 days apart."
11187743|NCT02108522|OG000|Outcome|Multivirus Specific T Cells|"Partially HLA-matched multivirus specific T cells (VSTs) will be thawed and given by intravenous injection. Patients will receive 2 x 10^7 VSTs/m2 as a single infusion. In the rare case where insufficient banked cell product is available, a lower number of cells may be infused after discussion with the principal investigator, patient and/or guardian and the treatment team.~If after the first treatment there is persistent infection, there is an option to receive more treatments. These additional treatments might be with cells from the same donor or another donor whose cells are also thought to be a good match for the patient and effective against their virus. This second product will be administered at the same dose level 28 days after the initial infusion, and subsequent infusions should be at least 14 days apart."
11238802|NCT02465632|FG002|Participant Flow|Placebo Topical Gel|Placebo: A thin layer of gel was applied to the entire affected areas on the face twice a day.
11238803|NCT02465632|OG000|Outcome|Test|Clindamycin and Benzoyl Peroxide Gel, 1%/5%
11238804|NCT02465632|OG001|Outcome|Reference|BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%
11187744|NCT02108522|EG000|Reported Event|Multivirus Specific T Cells|"Partially HLA-matched multivirus specific T cells (VSTs) will be thawed and given by intravenous injection. Patients will receive 2 x 10^7 VSTs/m2 as a single infusion. In the rare case where insufficient banked cell product is available, a lower number of cells may be infused after discussion with the principal investigator, patient and/or guardian and the treatment team.~If after the first treatment there is persistent infection, there is an option to receive more treatments. These additional treatments might be with cells from the same donor or another donor whose cells are also thought to be a good match for the patient and effective against their virus. This second product will be administered at the same dose level 28 days after the initial infusion, and subsequent infusions should be at least 14 days apart."
11187745|NCT02108600|BG000|Baseline|Standard of Care|Will continue usual immunosuppression and not receive any specific intervention.
11187746|NCT02108600|BG001|Baseline|Tocilizumab (TCZ) Group|"Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.~Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive reg"
11187747|NCT02108600|BG002|Baseline|Total|Total of all reporting groups
11187748|NCT02108600|FG000|Participant Flow|Standard of Care|Will continue usual immunosuppression and not receive any specific intervention.
11187749|NCT02108600|FG001|Participant Flow|Tocilizumab (TCZ) Group|"Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.~Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen."
11187750|NCT02108600|OG000|Outcome|Standard of Care|Will continue usual immunosuppression and not receive any specific intervention.
11187751|NCT02108600|OG001|Outcome|Tocilizumab (TCZ) Group|"Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.~Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen."
11187752|NCT02108600|EG000|Reported Event|Standard of Care|Will continue usual immunosuppression and not receive any specific intervention.
11187753|NCT02108600|EG001|Reported Event|Tocilizumab (TCZ) Group|"Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.~Tocilizumab: Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen."
11187754|NCT02108691|BG000|Baseline|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
11187755|NCT02108691|BG001|Baseline|Placebo|Placebo: Placebo (2.5g/day)
11187756|NCT02108691|BG002|Baseline|Total|Total of all reporting groups
11187757|NCT02108691|FG000|Participant Flow|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
11187758|NCT02108691|FG001|Participant Flow|Placebo|Placebo: Placebo (2.5g/day)
11187759|NCT02108691|OG000|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
11187760|NCT02108691|OG001|Outcome|Placebo|Placebo: Placebo (2.5g/day)
11187761|NCT02108691|EG000|Reported Event|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
11187762|NCT02108691|EG001|Reported Event|Placebo|Placebo: Placebo (2.5g/day)
11187763|NCT02108821|BG000|Baseline|Fecal Microbiome Transplantation|Use of Fecal Microbiome Transplantation for participants with IBD.
11187764|NCT02108821|FG000|Participant Flow|Fecal Microbiome Transplantation-open Label|"Fecal Microbiome Transplantation will be done at the time of EGD and colonoscopy. A parent or sibling or a healthy relative will be tested for several infections like hepatitis, H. Pylori, HIV, syphilis, ova and parasites, culture and C.diff. They will fill out a donor questionnaire used for blood donors prior to the sample collection. After eligibility criteria have been met, appropriate consent has been obtained, and the screening labs have been assessed, the fecal transplant procedure will take place in the procedure center at Children's Hospital of Pittsburgh. Fresh stool sample will be obtained from the donor. The fecal sample will be prepared for transplantation in a designated area in the procedure center. Frequency: once. Duration: Approximately 1 hour~Fecal Microbiota Transplantation (FMT): The process of fecal microbiota transplantation (FMT), where fecal bacteria from a healthy individual is transferred into a recipient as an alternative therapy for individuals affected"
11187765|NCT02108821|OG000|Outcome|Overall Study|Overall Study Events
11187766|NCT02108821|OG000|Outcome|Fecal Microbiome Transplantation Ulcerative Colitis/Indeterminate Colitis|Use of Fecal Microbiome Transplantation for participants with Ulcerative Colitis/Indeterminate Colitis.
11187767|NCT02108821|OG001|Outcome|Fecal Microbiome Transplantation With Crohn's Disease|Use of Fecal Microbiome Transplantation for participants with Crohn's Disease.
11187768|NCT02108821|EG000|Reported Event|Fecal Microbiota Transplantation|Use of Fecal Microbiota Transplantation for participants with IBD.
11187769|NCT02108912|BG000|Baseline|Traditional Outpatient|"Traditional outpatient physical therapy~Traditional outpatient: Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices."
11187770|NCT02108912|BG001|Baseline|ESTT Outpatient|"ESTT (early standardized task-specific training) in outpatient rehabilitation~ESTT: ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke"
11187771|NCT02108912|BG002|Baseline|Total|Total of all reporting groups
11187772|NCT02108912|FG000|Participant Flow|Traditional Outpatient|"Traditional outpatient physical therapy~Traditional outpatient: Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices."
11187773|NCT02108912|FG001|Participant Flow|ESTT Outpatient|"ESTT (early standardized task-specific training) in outpatient rehabilitation~ESTT: ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke"
11187774|NCT02108912|OG000|Outcome|Traditional Outpatient|"Traditional outpatient physical therapy~Traditional outpatient: Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices."
11187775|NCT02108912|OG001|Outcome|ESTT Outpatient|"ESTT (early standardized task-specific training) in outpatient rehabilitation~ESTT: ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke"
11187776|NCT02108912|EG000|Reported Event|Traditional Outpatient|"Traditional outpatient physical therapy~Traditional outpatient: Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices."
11187777|NCT02108912|EG001|Reported Event|ESTT Outpatient|"ESTT (early standardized task-specific training) in outpatient rehabilitation~ESTT: ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke"
11187778|NCT02108951|BG000|Baseline|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
11187779|NCT02108951|FG000|Participant Flow|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
11187780|NCT02108951|OG000|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
11187781|NCT02108951|EG000|Reported Event|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study
11187782|NCT02108977|BG000|Baseline|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
11187783|NCT02108977|BG001|Baseline|Telephone Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
11187784|NCT02108977|BG002|Baseline|Total|Total of all reporting groups
11187785|NCT02108977|FG000|Participant Flow|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
11187786|NCT02108977|FG001|Participant Flow|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
11187787|NCT02108977|OG000|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
11187788|NCT02108977|OG001|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
11187789|NCT02108977|OG000|Outcome|Videoconferencing Genetic Consultation|Counselors provided genetic counseling via videoconferencing.
11187790|NCT02108977|OG001|Outcome|Teleconferencing Genetic Consultation|Counselors provided genetic counseling via telephone.
11187791|NCT02108977|EG000|Reported Event|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
11187792|NCT02108977|EG001|Reported Event|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
11187793|NCT02109029|BG000|Baseline|Part A Low/High Insulin Peglispro|Participants received 4.00 U priming dose and 1.84 U/h constant IV infusion or 8.00 U priming dose and 4.50 U/h constant IV infusionconstant IV infusion of insulin peglispro for 36 hours with up to 2 weeks between doses.
11238805|NCT02465632|OG002|Outcome|Placebo|Placebo: Placebo topical gel
10962099|NCT00864721|OG000|Outcome|Sunitinib Malate|"Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.~Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle."
11187794|NCT02109029|BG001|Baseline|Part A Intermediate Insulin Peglispro|Participants received 4.00 U priming dose and 1.84 U/h constant IV infusion or 6.00 U priming dose and 2.76U/h constant IV infusion constant IV infusion of insulin peglispro for 36 hours with up to 2 weeks between doses.
11187795|NCT02109029|BG002|Baseline|Part B|Participants first received a priming dose of 8.00 U followed by 2.76 U/h constant intravenous (IV) infusion of LY2605541 for 36 hours or 6 pmol/kg/min constant infusion of human insulin with up to 2 weeks between doses.
11187796|NCT02109029|BG003|Baseline|Total|Total of all reporting groups
11187797|NCT02109029|FG000|Participant Flow|Part A: Cohort 1 Insulin Peglispro Low/High|Participants received a priming dose of 2.00 U and 0.92 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours as treatment 1 and received a priming dose of 8.00 U and 4.50/h constant infusion with at least 6 days between doses) as treatment 2.
11187798|NCT02109029|FG001|Participant Flow|Part A: Cohort 1 Insulin Peglispro High/Low|Participants received a priming dose of 8.00 U and 4.50 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours as treatment 1, and an IV priming dose of 2.00 U and 0.92 U/hour constant infusion as treatment 2.
11187799|NCT02109029|FG002|Participant Flow|Part A: Cohort 2 Insulin Peglispro Intermediate Dose 1 and 2|Participants received a priming dose of 4.00 U and 1.84 U/h a constant intravenous (IV) of insulin peglispro for 36 hours as treatment 1, and a 6.00 U priming dose and constant infusion of 2.76U/h of insulin peglispro as treatment 2.
11187800|NCT02109029|FG003|Participant Flow|Part A: Cohort 2 Insulin Peglispro, Intermediate Dose 2 and 1|Participants received a priming dose of 6.00 U and 2.76 U/h constant infusion of insulin peglispro as treatment 1, and 4.00 U and 1.84 U/h constant infusion of insulin peglispro for 36 hours as treatment 2.
11187801|NCT02109029|FG004|Participant Flow|Part B: Insulin Peglispro/Human Insulin|Participant received a priming dose of 6.00 U and 2.76 constant intravenous infusion of insulin peglispro for 36 hours as treatment 1 and 6 pmol/kg/min constant infusion of human insulin as treatment 2.
11187802|NCT02109029|FG005|Participant Flow|Part B: Human Insulin/Insulin Peglispro|Participant received 6 pmol/kg/min constant infusion of human insulin IV as treatment 1 and a priming dose of 6.00 U and 2.76 U/h constant infusion of insulin peglispro and a constant infusion for 36 hours as treatment 2.
11187803|NCT02109029|OG000|Outcome|Insulin Peglispro|Participants received a priming dose of 2.00 U LY2605541 followed by a constant infusion of 0.92 U/h for up to 36 hours.
11187804|NCT02109029|OG001|Outcome|Human Insulin|Participants received 6 pmol/kg/min constant IV infusion of human insulin for up to 36 hours
11187805|NCT02109029|OG001|Outcome|Human Insulin|Participants received 6 pmol/kg/min constant IV infusion of human insulin for up to 36 hours.
11187806|NCT02109029|EG000|Reported Event|Part A: Insulin Peglispro 2U|Participants received a priming dose of 2.00 U and 0.92 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours.
11187807|NCT02109029|EG001|Reported Event|Part A: Insulin Peglispro 4U|Participants received a priming dose of 4.00 U and 4.50 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours.
11187808|NCT02109029|EG002|Reported Event|Part A: Insulin Peglispro 6U|Participant received a priming dose of 6.00 U and 1.84 constant IV infusion of insulin peglispro respectively, for 36 hours.
11187809|NCT02109029|EG003|Reported Event|Part A: Insulin Peglispro 8U|Participant received a priming dose of 8.00 U and 2.76 constant IV infusion of insulin peglispro respectively, for 36 hours.
11187810|NCT02109029|EG004|Reported Event|Part B: Insulin Peglispro|Participant received a priming dose of 6.00 U and 2.76 constant intravenous infusion of insulin peglispro for 36 hours.
11187811|NCT02109029|EG005|Reported Event|Part B: Human Insulin|Participants received 6 pmol/kg/min constant IV infusion of human insulin for up to 36 hours.
11187812|NCT02109042|BG000|Baseline|Weekly SC Blosozumab Injections|"Blosozumab was to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.~A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2."
11187813|NCT02109042|FG000|Participant Flow|Weekly Subcutaneous Blosozumab Injections|"Blosozumab was to be administered as a subcutaneous (SC) injection (90 milligrams per milliliter (mg/mL) solution in prefilled syringes) weekly for 6 weeks.~A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2."
11187814|NCT02109042|OG000|Outcome|Weekly SC Blosozumab Injections|"Blosozumab was to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.~A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2."
11187815|NCT02109042|EG000|Reported Event|180 mg SC Blosozumab Injection|"Blosozumab was planned to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.~A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1."
11187816|NCT02109042|EG001|Reported Event|90 mg SC Blosozumab Injections|"Blosozumab was planned to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.~Once weekly 90 mg dose (single 1 mL injection) were administered beginning on Day 1 of Week 2.~Data from all participants who received at least 1 90 mg/mL SC Blozozumab injection are included."
11238806|NCT02465632|OG002|Outcome|Placebo|Placebo: Placebo Topical Gel
11238807|NCT02465632|EG000|Reported Event|Test|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
11238808|NCT02465632|EG001|Reported Event|Reference|BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
11238809|NCT02465632|EG002|Reported Event|Placebo|Placebo topical gel
11238810|NCT02465866|BG000|Baseline|Overall Subjects|
11238811|NCT02465866|FG000|Participant Flow|Sequence 1: ABDC|"Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Dosing in 4 study periods was separated by a 14-day washout period"
11238812|NCT02465866|FG001|Participant Flow|Sequence 2: BCAD|"Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Dosing in 4 study periods was separated by a 14-day washout period"
11238813|NCT02465866|FG002|Participant Flow|Sequence 3: CDBA|"Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Dosing in 4 study periods was separated by a 14-day washout period"
11238814|NCT02465866|FG003|Participant Flow|Sequence 4: DACB|"Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Dosing in 4 study periods was separated by a 14-day washout period"
11238815|NCT02465866|OG000|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
11238816|NCT02465866|OG001|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
11238817|NCT02465866|OG002|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
11238818|NCT02465866|OG003|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
11238819|NCT02465866|EG000|Reported Event|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
11238820|NCT02465866|EG001|Reported Event|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
11238821|NCT02465866|EG002|Reported Event|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
11238822|NCT02465866|EG003|Reported Event|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
11238823|NCT02465931|BG000|Baseline|Intervention Condition|Digital informed consent tool
11238824|NCT02465931|BG001|Baseline|Comparison Condition|Paper and pencil informed consent
11238825|NCT02465931|BG002|Baseline|Total|Total of all reporting groups
11238826|NCT02465931|FG000|Participant Flow|Intervention Condition|Digital informed consent tool
11238827|NCT02465931|FG001|Participant Flow|Comparison Condition|Paper and pencil informed consent
11238828|NCT02465931|OG000|Outcome|Intervention Condition|Digital informed consent tool
11238829|NCT02465931|OG001|Outcome|Comparison Condition|Paper and pencil informed consent
11238830|NCT02465931|EG000|Reported Event|Intervention Condition|Digital informed consent tool
11238831|NCT02465931|EG001|Reported Event|Comparison Condition|Paper and pencil informed consent
11238832|NCT02466009|BG000|Baseline|Regorafenib|"120 mg qd, 3 weeks on/1 week off (each cycle is 28 days)~Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast.~Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets)."
11238833|NCT02466009|FG000|Participant Flow|Regorafenib|"120 mg qd, 3 weeks on/1 week off (each cycle is 28 days)~Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast.~Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets)."
11238834|NCT02466009|OG000|Outcome|Regorafenib|"120 mg qd, 3 weeks on/1 week off (each cycle is 28 days)~Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast.~Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets)."
11238835|NCT02466009|EG000|Reported Event|Regorafenib|"120 mg qd, 3 weeks on/1 week off (each cycle is 28 days)~Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast.~Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets)."
11238836|NCT02466087|BG000|Baseline|Entire Study Population|Includes groups randomized to receive MgCl first and no intervention first
11238837|NCT02466087|FG000|Participant Flow|Mg Cl (Weeks 1-6), Then no Intervention (Weeks 7-12)|MgCl for weeks 1-6 and then no treatment for weeks 7-12
11238838|NCT02466087|FG001|Participant Flow|No Intervention (Weeks 1-6), Then MgCl (Weeks 7-12)|No Treatment for weeks 1-6 and then MgCl for weeks 7-12
11238839|NCT02466087|OG000|Outcome|MgCl|6 weeks of MgCl supplements
11238840|NCT02466087|OG001|Outcome|Control|6 weeks of no supplements
11238841|NCT02466087|OG000|Outcome|MgCl|6 weeks of MgCl supplementation
11238842|NCT02466087|EG000|Reported Event|Mg Supplementation|6 weeks of Mg Supplements
11238843|NCT02466087|EG001|Reported Event|Control|6 weeks of no MgCl supplements
11238844|NCT02466126|BG000|Baseline|bCBT/Direct Referral|"A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.~bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to emotional health (e.g., depression) but may also address physical health concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health)."
11238845|NCT02466126|BG001|Baseline|Enhanced Usual Care (EUC)|Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
11238846|NCT02466126|BG002|Baseline|Total|Total of all reporting groups
11238847|NCT02466126|FG000|Participant Flow|bCBT/Direct Referral|"A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.~bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to emotional health (e.g., depression) but may also address physical health concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health)."
11238848|NCT02466126|FG001|Participant Flow|Enhanced Usual Care (EUC)|Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
11238849|NCT02466126|OG000|Outcome|bCBT/Direct Referral|"A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.~bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to emotional health (e.g., depression) but may also address physical health concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health)."
11238850|NCT02466126|OG001|Outcome|Enhanced Usual Care (EUC)|Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
11238851|NCT02466126|EG000|Reported Event|bCBT/Direct Referral|"A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.~bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to emotional health (e.g., depression) but may also address physical health concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health)."
11238852|NCT02466126|EG001|Reported Event|Enhanced Usual Care (EUC)|Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
11238853|NCT02466230|BG000|Baseline|Active rTMS|"Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.~Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min."
11238854|NCT02466230|FG000|Participant Flow|Active rTMS|"Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.~Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min."
11341805|NCT03688620|OG000|Outcome|Vaccinated_Fluarix Tetra Group|Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
11360451|NCT02608905|BG000|Baseline|Dapagliflozin|"Dapagliflozin 5 mg daily by mouth for 2 weeks followed by 10 mg by mouth daily for 10 weeks~Dapagliflozin: Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo."
11360452|NCT02608905|BG001|Baseline|Placebo|"Placebo tablets by mouth daily for 12 weeks~Placebo: Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo."
11360453|NCT02608905|BG002|Baseline|Total|Total of all reporting groups
11360454|NCT02608905|FG000|Participant Flow|Dapagliflozin|"Dapagliflozin 5 mg daily by mouth for 2 weeks followed by 10 mg by mouth daily for 10 weeks~Dapagliflozin: Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo."
11360455|NCT02608905|FG001|Participant Flow|Placebo|"Placebo tablets by mouth daily for 12 weeks~Placebo: Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo."
11360456|NCT02608905|OG000|Outcome|Dapagliflozin|"Dapagliflozin 5 mg daily by mouth for 2 weeks followed by 10 mg by mouth daily for 10 weeks~Dapagliflozin: Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo."
11360457|NCT02608905|OG001|Outcome|Placebo|"Placebo tablets by mouth daily for 12 weeks~Placebo: Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo."
11360458|NCT02608905|EG000|Reported Event|Dapagliflozin|"Dapagliflozin 5 mg daily by mouth for 2 weeks followed by 10 mg by mouth daily for 10 weeks~Dapagliflozin: Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo."
11360459|NCT02608905|EG001|Reported Event|Placebo|"Placebo tablets by mouth daily for 12 weeks~Placebo: Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo."
11360460|NCT02619812|BG000|Baseline|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
11360461|NCT02619812|BG001|Baseline|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
11360462|NCT02619812|BG002|Baseline|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
11360463|NCT02619812|BG003|Baseline|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
11360464|NCT02619812|BG004|Baseline|Total|Total of all reporting groups
11360465|NCT02619812|FG000|Participant Flow|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
11360466|NCT02619812|FG001|Participant Flow|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
11360467|NCT02619812|FG002|Participant Flow|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
11360468|NCT02619812|FG003|Participant Flow|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
11360469|NCT02619812|OG000|Outcome|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
11360470|NCT02619812|OG001|Outcome|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
11360471|NCT02619812|OG002|Outcome|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
11360472|NCT02619812|OG003|Outcome|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
11360473|NCT02619812|EG000|Reported Event|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
11360474|NCT02619812|EG001|Reported Event|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
11238855|NCT02466230|OG000|Outcome|Active rTMS|"Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.~Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min."
11238856|NCT02466230|EG000|Reported Event|Active rTMS|"Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.~Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min."
11238857|NCT02466386|BG000|Baseline|SPD489|Participants received 5 milligrams (mg) of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 52 weeks.
11238858|NCT02466386|FG000|Participant Flow|SPD489|Participants received 5 milligrams (mg) of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 52 weeks.
11238859|NCT02466386|OG000|Outcome|SPD489|Participants received 5 milligrams (mg) of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 52 weeks.
11238860|NCT02466386|EG000|Reported Event|Total|Participants received 5 mg of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 52 weeks.
11238861|NCT02466399|BG000|Baseline|POLAT-001|"Latanoprost liposome ophthalmic injection~POLAT-001: Subconjunctival injection"
11238862|NCT02466399|BG001|Baseline|Latanoprost Ophthalmic Solution|"latanoprost ophthalmic solution 0.005%~Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening"
11238863|NCT02466399|BG002|Baseline|Total|Total of all reporting groups
11238864|NCT02466399|FG000|Participant Flow|POLAT-001|"Latanoprost liposome ophthalmic injection~POLAT-001: Subconjunctival injection"
11238865|NCT02466399|FG001|Participant Flow|Latanoprost Ophthalmic Solution|"latanoprost ophthalmic solution 0.005%~Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening"
11238866|NCT02466399|OG000|Outcome|POLAT-001|"Latanoprost liposome ophthalmic injection~POLAT-001: Subconjunctival injection"
11238867|NCT02466399|OG001|Outcome|Latanoprost Ophthalmic Solution|"latanoprost ophthalmic solution 0.005%~Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening"
11238868|NCT02466399|EG000|Reported Event|POLAT-001|"Latanoprost liposome ophthalmic injection~POLAT-001: Subconjunctival injection"
11238869|NCT02466399|EG001|Reported Event|Latanoprost Ophthalmic Solution|"latanoprost ophthalmic solution 0.005%~Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening"
11238870|NCT02466412|BG000|Baseline|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
11238871|NCT02466412|BG001|Baseline|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
11238872|NCT02466412|BG002|Baseline|Total|Total of all reporting groups
11238873|NCT02466412|FG000|Participant Flow|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
11238874|NCT02466412|FG001|Participant Flow|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
11238875|NCT02466412|OG000|Outcome|CHTP 1.1 M|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
11238876|NCT02466412|OG001|Outcome|Menthol Cigarette (mCC)|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
11238877|NCT02466412|EG000|Reported Event|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
11238878|NCT02466412|EG001|Reported Event|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
11238879|NCT02466412|EG002|Reported Event|Enrolled But Not Randomized|Subjects who tried the CHTP 1.1 M at Admission but were not randomized in 1 of the 2 sequences as they were back-up subjects
11240867|NCT02482610|FG001|Participant Flow|Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes."
11360475|NCT02619812|EG002|Reported Event|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
11360476|NCT02619812|EG003|Reported Event|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
11360477|NCT02612285|BG000|Baseline|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422.~SNX-5422: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle"
11360478|NCT02612285|FG000|Participant Flow|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422.~SNX-5422: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle"
11360479|NCT02612285|OG000|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422.~SNX-5422: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle"
11360480|NCT02612285|EG000|Reported Event|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422.~SNX-5422: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle"
11360481|NCT02614586|BG000|Baseline|Part-1: Screening Phase|Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
11360482|NCT02614586|FG000|Participant Flow|Part-1: Screening Phase|Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
11360483|NCT02614586|OG000|Outcome|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
11360484|NCT02614586|EG000|Reported Event|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
11376232|NCT01238211|FG000|Participant Flow|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
11376233|NCT01238211|OG000|Outcome|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
11376234|NCT01238211|EG000|Reported Event|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
11376235|NCT01177540|BG000|Baseline|Treatment A: Decitabine + Induction Chemotherapy|Participants received decitabine 20 mg/m^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
11376236|NCT01177540|BG001|Baseline|Treatment B: Induction Chemotherapy Only|Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
11376237|NCT01177540|BG002|Baseline|Total|Total of all reporting groups
11376238|NCT01177540|FG000|Participant Flow|Treatment A: Decitabine + Induction Chemotherapy|Participants received decitabine 20 milligram per square meter (mg/m^2) infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
11376239|NCT01177540|FG001|Participant Flow|Treatment B: Induction Chemotherapy Only|Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
11376240|NCT01177540|OG000|Outcome|Treatment A: Decitabine + Induction Chemotherapy|Participants received decitabine 20 mg/m^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
11360485|NCT02606279|BG000|Baseline|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
11360486|NCT02606279|BG001|Baseline|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
11360487|NCT02606279|BG002|Baseline|Total|Total of all reporting groups
11360488|NCT02606279|FG000|Participant Flow|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
11360489|NCT02606279|FG001|Participant Flow|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
11360490|NCT02606279|OG000|Outcome|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
11360491|NCT02606279|OG001|Outcome|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
11360492|NCT02606279|EG000|Reported Event|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
11360493|NCT02606279|EG001|Reported Event|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
11360494|NCT02605824|BG000|Baseline|20% N-acetylcystine (NAC)|"NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.~n-acetylcystine: NAC is a mucolytic drug."
11360495|NCT02605824|BG001|Baseline|0.9% Saline|"Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.~0.9% saline: Normal saline is a placebo agent."
11360496|NCT02605824|BG002|Baseline|Total|Total of all reporting groups
11360497|NCT02605824|FG000|Participant Flow|20% N-acetylcystine (NAC)|"NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.~n-acetylcystine: NAC is a mucolytic drug."
11360498|NCT02605824|FG001|Participant Flow|0.9% Saline|"Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.~0.9% saline: Normal saline is a placebo agent."
11360499|NCT02605824|OG000|Outcome|20% N-acetylcystine (NAC)|"NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.~n-acetylcystine: NAC is a mucolytic drug."
11360500|NCT02605824|OG001|Outcome|0.9% Saline|"Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.~0.9% saline: Normal saline is a placebo agent."
11360501|NCT02605824|EG000|Reported Event|20% N-acetylcystine (NAC)|"NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.~n-acetylcystine: NAC is a mucolytic drug."
11360502|NCT02605824|EG001|Reported Event|0.9% Saline|"Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.~0.9% saline: Normal saline is a placebo agent."
11360503|NCT02598622|BG000|Baseline|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
11360504|NCT02598622|BG001|Baseline|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
11360505|NCT02598622|BG002|Baseline|Total|Total of all reporting groups
11360506|NCT02598622|FG000|Participant Flow|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
11360507|NCT02598622|FG001|Participant Flow|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
11360508|NCT02598622|OG000|Outcome|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
11360509|NCT02598622|OG001|Outcome|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
10962100|NCT00864721|EG000|Reported Event|Sunitinib Malate|"Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.~Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle."
10962101|NCT00864851|BG000|Baseline|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
11238880|NCT02466425|BG000|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11238881|NCT02466425|BG001|Baseline|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
11238882|NCT02466425|BG002|Baseline|Total|Total of all reporting groups
11238883|NCT02466425|FG000|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11238884|NCT02466425|FG001|Participant Flow|SHP465|Participants received SHP465 capsule (12.5 milligram [mg] during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
11238885|NCT02466425|OG000|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11238886|NCT02466425|OG001|Outcome|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
11238887|NCT02466425|EG000|Reported Event|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11238888|NCT02466425|EG001|Reported Event|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during dose maintenance phase) orally once daily for 4 weeks.
11238889|NCT02466516|BG000|Baseline|SEL 6 mg|Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
11238890|NCT02466516|BG001|Baseline|SEL 18 mg|SEL 18 mg tablet once daily for 24 weeks.
11238891|NCT02466516|BG002|Baseline|SEL 6 mg+SIM 125 mg|SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238892|NCT02466516|BG003|Baseline|SEL 18 mg+SIM 125 mg|SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238893|NCT02466516|BG004|Baseline|SIM 125 mg|SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238894|NCT02466516|BG005|Baseline|Total|Total of all reporting groups
11238895|NCT02466516|FG000|Participant Flow|SEL 6 mg|Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
11238896|NCT02466516|FG001|Participant Flow|SEL 18 mg|SEL 18 mg tablet once daily for 24 weeks.
11238897|NCT02466516|FG002|Participant Flow|SEL 6 mg+SIM 125 mg|SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238898|NCT02466516|FG003|Participant Flow|SEL 18 mg+SIM 125 mg|SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238899|NCT02466516|FG004|Participant Flow|SIM 125 mg|SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238900|NCT02466516|OG000|Outcome|SEL 6 mg|Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
11238901|NCT02466516|OG001|Outcome|SEL 18 mg|SEL 18 mg tablet once daily for 24 weeks.
11238902|NCT02466516|OG002|Outcome|SEL 6 mg+SIM 125 mg|SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238903|NCT02466516|OG003|Outcome|SEL 18 mg+SIM 125 mg|SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238904|NCT02466516|OG004|Outcome|SIM 125 mg|SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238905|NCT02466516|EG000|Reported Event|SEL 6 mg|Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
11238906|NCT02466516|EG001|Reported Event|SEL 18 mg|SEL 18 mg tablet once daily for 24 weeks.
11238907|NCT02466516|EG002|Reported Event|SEL 6 mg+SIM 125 mg|SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238908|NCT02466516|EG003|Reported Event|SEL 18 mg+SIM 125 mg|SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238909|NCT02466516|EG004|Reported Event|SIM 125 mg|SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
11238910|NCT02466555|BG000|Baseline|Music Therapy Group|Music Therapy: During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may include but are not limited to original songs/rap/instrumental playing, vocal and/or instrumental improvisation, patient-contributed lyrics, mnemonics, and stress and pain reducing strategies. The music therapy interventions will be tailored to best convey the educational message.
11238911|NCT02466555|FG000|Participant Flow|Music Therapy Group|Music Therapy: During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may
11238912|NCT02466555|OG000|Outcome|Music Therapy Group|Music Therapy: During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may include but are not limited to original songs/rap/instrumental playing, vocal and/or instrumental improvisation, patient-contributed lyrics, mnemonics, and stress and pain reducing strategies. The music therapy interventions will be tailored to best convey the educational message.
11187817|NCT02109107|BG000|Baseline|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
11187818|NCT02109107|FG000|Participant Flow|Erchonia® Zerona 6 Headed Scanner (EZ6) Laser|"The Erchonia® Zerona 6 Headed Scanner (EZ6) Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
11187819|NCT02109107|OG000|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
11187820|NCT02109107|EG000|Reported Event|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
11187821|NCT02109133|BG000|Baseline|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
11187822|NCT02109133|BG001|Baseline|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
11187823|NCT02109133|BG002|Baseline|Total|Total of all reporting groups
11187824|NCT02109133|FG000|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
11187825|NCT02109133|FG001|Participant Flow|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
11187826|NCT02109133|OG000|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
11187827|NCT02109133|OG001|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
11187828|NCT02109133|OG000|Outcome|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
11187829|NCT02109133|OG001|Outcome|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
11187830|NCT02109133|EG000|Reported Event|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
11187831|NCT02109133|EG001|Reported Event|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
11187832|NCT02109159|BG000|Baseline|Emotional Video|"a short online video (243 minutes long) about the WOMAN trial with more emotional content (an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience)"
11187833|NCT02109159|BG001|Baseline|Control Video|"a short online video (243 minutes long) about the WOMAN trial with less emotional content (the interviewer provides a second hand description of the experience)"
11187834|NCT02109159|BG002|Baseline|Total|Total of all reporting groups
11187835|NCT02109159|FG000|Participant Flow|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
11187836|NCT02109159|FG001|Participant Flow|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
11187837|NCT02109159|OG000|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
11187838|NCT02109159|OG001|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
11187839|NCT02109159|EG000|Reported Event|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
11187840|NCT02109159|EG001|Reported Event|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
11360510|NCT02598622|EG000|Reported Event|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
11360511|NCT02598622|EG001|Reported Event|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
11360512|NCT02589145|BG000|Baseline|Lenalidomide Dose Level 1|Lenalidomide 50 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360513|NCT02589145|BG001|Baseline|Lenalidomide Dose Level 2|Lenalidomide 75 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360514|NCT02589145|BG002|Baseline|Lenalidomide Dose Level 3|Lenalidomide 100 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360515|NCT02589145|BG003|Baseline|Total|Total of all reporting groups
11360516|NCT02589145|FG000|Participant Flow|Lenalidomide Dose Level 1|Lenalidomide 50 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360517|NCT02589145|FG001|Participant Flow|Lenalidomide Dose Level 2|Lenalidomide 75 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360518|NCT02589145|FG002|Participant Flow|Lenalidomide Dose Level 3|Lenalidomide 100 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360519|NCT02589145|OG000|Outcome|Lenalidomide Dose Level 1|Lenalidomide 50 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360520|NCT02589145|OG001|Outcome|Lenalidomide Dose Level 2|Lenalidomide 75 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360521|NCT02589145|OG002|Outcome|Lenalidomide Dose Level 3|Lenalidomide 100 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360522|NCT02589145|EG000|Reported Event|Lenalidomide Dose Level 1|Lenalidomide 50 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360523|NCT02589145|EG001|Reported Event|Lenalidomide Dose Level 2|Lenalidomide 75 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
10962102|NCT00864851|BG001|Baseline|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
11187841|NCT02109419|BG000|Baseline|All Participants|All participants, inclusive of those with no memory impairment, mild cognitive impairment, and dementia.
10962103|NCT00864851|BG002|Baseline|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
10962104|NCT00864851|BG003|Baseline|Total|Total of all reporting groups
10962105|NCT00864851|FG000|Participant Flow|Replagal 0.2 mg/kg, IV, Every Other Week|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
10962106|NCT00864851|FG001|Participant Flow|Replagal 0.2 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
10962107|NCT00864851|FG002|Participant Flow|Replagal 0.4 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
10962108|NCT00864851|OG000|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
10962109|NCT00864851|OG001|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
10962110|NCT00864851|OG002|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
10962111|NCT00864851|OG003|Outcome|Overall|Total of all reporting groups.
10962112|NCT00864851|EG000|Reported Event|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
10962113|NCT00864851|EG001|Reported Event|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
10962114|NCT00864851|EG002|Reported Event|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
10962115|NCT00864851|EG003|Reported Event|Overall|Total of all reporting groups.
11187842|NCT02109419|FG000|Participant Flow|All Participants|All participants, including control, mild cognitive impairment (MCI), and dementia.
11187843|NCT02109419|OG000|Outcome|All Participants|All participants, including those with no memory impairment, mild cognitive impairment, and dementia.
11187844|NCT02109419|EG000|Reported Event|Control|Mini Mental State Exam (MMSE) score 29-30; inclusive
11187845|NCT02109419|EG001|Reported Event|Mild Cognitive Impairment|MMSE score 25-28; inclusive
11238913|NCT02466555|OG000|Outcome|Music Therapy Group|Music Therapy: During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may
11238914|NCT02466555|EG000|Reported Event|Music Therapy Group|Music Therapy: During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may
11238915|NCT02466646|BG000|Baseline|Full-mouth Disinfection IPT|Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
11238916|NCT02466646|BG001|Baseline|Conventional IPT|Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
11238917|NCT02466646|BG002|Baseline|Full-mouth IPT|Initial periodontal treatment was performed in 2 sessions within 24 hours.
11238918|NCT02466646|BG003|Baseline|Total|Total of all reporting groups
11238919|NCT02466646|FG000|Participant Flow|Full-mouth Disinfection IPT|Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
11238920|NCT02466646|FG001|Participant Flow|Conventional IPT|Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
11238921|NCT02466646|FG002|Participant Flow|Full-mouth IPT|Initial periodontal treatment was performed in 2 sessions within 24 hours.
11238922|NCT02466646|OG000|Outcome|Full-mouth Disinfection IPT|Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
11238923|NCT02466646|OG001|Outcome|Conventional IPT|Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
11238924|NCT02466646|OG002|Outcome|Full-mouth IPT|Initial periodontal treatment was performed in 2 sessions within 24 hours.
11238925|NCT02466646|OG000|Outcome|Full-mouth Disinfection IPT|"Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks).~Klorhex® Gel, rinse and spray: Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks)."
11238926|NCT02466646|OG001|Outcome|Conventional IPT|"Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.~Conventional IPT: Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals."
11238927|NCT02466646|OG002|Outcome|Full-mouth IPT|"Initial periodontal treatment was performed in 2 sessions within 24 hours.~Full-mouth IPT: Initial periodontal treatment was performed in 2 sessions within 24 hours."
11238928|NCT02466646|EG000|Reported Event|Full-mouth Disinfection IPT|Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
11238929|NCT02466646|EG001|Reported Event|Conventional IPT|Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
11238930|NCT02466646|EG002|Reported Event|Full-mouth IPT|Initial periodontal treatment was performed in 2 sessions within 24 hours.
11238931|NCT02466659|BG000|Baseline|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
11238932|NCT02466659|BG001|Baseline|Observation|To observe as one kind of standard care for IXT.
11238933|NCT02466659|BG002|Baseline|Total|Total of all reporting groups
11238934|NCT02466659|FG000|Participant Flow|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
11238935|NCT02466659|FG001|Participant Flow|Observation|To observe as one kind of standard care for IXT.
11238936|NCT02466659|OG000|Outcome|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
11238937|NCT02466659|OG001|Outcome|Observation|To observe as one kind of standard care for IXT.
11238938|NCT02466659|EG000|Reported Event|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
11238939|NCT02466659|EG001|Reported Event|Observation|To observe as one kind of standard care for IXT.
11238940|NCT02466958|BG000|Baseline|Levomilnacipran (FETZIMA)|"All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.~levomilnacipran: antidepressant"
11238941|NCT02466958|BG001|Baseline|Placebo|"All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.~Placebo: an inactive drug"
11238942|NCT02466958|BG002|Baseline|Total|Total of all reporting groups
11238943|NCT02466958|FG000|Participant Flow|Levomilnacipran (FETZIMA)|"All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.~levomilnacipran: antidepressant"
11376241|NCT01177540|OG001|Outcome|Treatment B: Induction Chemotherapy Only|Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
10962116|NCT00864916|BG000|Baseline|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
10962117|NCT00864916|BG001|Baseline|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
10962118|NCT00864916|BG002|Baseline|Total|Total of all reporting groups
11187846|NCT02109419|EG002|Reported Event|Dementia|MMSE score 10-24; inclusive
11360524|NCT02589145|EG002|Reported Event|Lenalidomide Dose Level 3|Lenalidomide 100 mg PO for 8 days+Vorinostat 1000 mg PO for 8 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto Stem Cell Transplant (SCT)
11360525|NCT02582749|BG000|Baseline|Control Arm A|"All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days.~LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.~Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle."
11360526|NCT02582749|BG001|Baseline|Experimental Arm B|"All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles.~LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.~Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.~Radium-223 dichloride: Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections"
11360527|NCT02582749|BG002|Baseline|Total|Total of all reporting groups
11360528|NCT02582749|FG000|Participant Flow|Control Arm A|"All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days.~LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.~Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle."
11360529|NCT02582749|FG001|Participant Flow|Experimental Arm B|"All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles.~LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.~Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.~Radium-223 dichloride: Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections"
11360530|NCT02582749|OG000|Outcome|Control Arm A|"All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days.~LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.~Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle."
11360531|NCT02582749|OG001|Outcome|Experimental Arm B|"All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles.~LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.~Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.~Radium-223 dichloride: Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections"
11360532|NCT02582749|EG000|Reported Event|Control Arm A|"All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days.~LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.~Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle."
11360533|NCT02582749|EG001|Reported Event|Experimental Arm B|"All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles.~LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.~Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.~Radium-223 dichloride: Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections"
11187847|NCT02109432|BG000|Baseline|Pedal Desk|"Participants will complete three 2-week pedal desk conditions in the following order:~Self-directed Pedal Desk~Facilitated Pedal Desk~Facilitated Pedal Desk with Pedometer"
11187848|NCT02109432|FG000|Participant Flow|Pedal Desk|Three 2-week pedal desk conditions (Self-directed, Facilitated and Facilitated Pedal Desk with Pedometer)
11187849|NCT02109432|OG000|Outcome|Pedal Desk|Three 2-week pedal desk conditions (Self-directed, Facilitated and Facilitated Pedal Desk with Pedometer)
11187850|NCT02109432|EG000|Reported Event|Pedal Desk|"Participants will complete three 2-week pedal desk conditions in the following order:~Self-directed Pedal Desk~Facilitated Pedal Desk~Facilitated Pedal Desk with Pedometer"
11360534|NCT02590068|BG000|Baseline|Hepatitis C Infected Volunteers|"Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers~Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously"
11360535|NCT02590068|BG001|Baseline|Healthy Volunteers|"Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers~Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously"
11360536|NCT02590068|BG002|Baseline|Total|Total of all reporting groups
11360537|NCT02590068|FG000|Participant Flow|Hepatitis C Infected Volunteers|"Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers~Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously"
11360538|NCT02590068|FG001|Participant Flow|Healthy Volunteers|"Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers~Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously"
11360539|NCT02590068|OG000|Outcome|Hepatitis C Infected Volunteers|"Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers~Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously"
11360540|NCT02590068|OG001|Outcome|Healthy Volunteers|"Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers~Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously"
11360541|NCT02590068|EG000|Reported Event|Hepatitis C Infected Volunteers|"Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers~Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously"
11360542|NCT02590068|EG001|Reported Event|Healthy Volunteers|"Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers~Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously"
11360543|NCT02593682|BG000|Baseline|Suvorexant Group|"In this arm, subjects will receive 10 mg suvorexant 2 hours before a one-minute 35% CO2 challenge.~suvorexant"
11360544|NCT02593682|BG001|Baseline|Placebo Group|"In this arm, subjects will receive a placebo, compounded to look identical to the study drug, 2 hours before a one-minute 35% CO2 challenge.~placebo"
11360545|NCT02593682|BG002|Baseline|Total|Total of all reporting groups
11360546|NCT02593682|FG000|Participant Flow|Suvorexant Group|"In this arm, subjects will receive 10 mg suvorexant 2 hours before a one-minute 35% CO2 challenge.~suvorexant"
11360547|NCT02593682|FG001|Participant Flow|Placebo Group|"In this arm, subjects will receive a placebo, compounded to look identical to the study drug, 2 hours before a one-minute 35% CO2 challenge.~placebo"
11360548|NCT02593682|OG000|Outcome|Suvorexant Group|"In this arm, subjects will receive 10 mg suvorexant 2 hours before a one-minute 35% CO2 challenge.~suvorexant"
11360549|NCT02593682|OG001|Outcome|Placebo Group|"In this arm, subjects will receive a placebo, compounded to look identical to the study drug, 2 hours before a one-minute 35% CO2 challenge.~placebo"
11360550|NCT02593682|EG000|Reported Event|Suvorexant Group|"In this arm, subjects will receive 10 mg suvorexant 2 hours before a one-minute 35% CO2 challenge.~suvorexant"
11360551|NCT02593682|EG001|Reported Event|Placebo Group|"In this arm, subjects will receive a placebo, compounded to look identical to the study drug, 2 hours before a one-minute 35% CO2 challenge.~placebo"
11360552|NCT02587650|BG000|Baseline|Arm C (Regorafenib)|Participants with RET or BRAF mutations
11360553|NCT02587650|FG000|Participant Flow|Arm A (Capmatinib)|"Patients with MET fusion receive capmatinib orally (PO), twice a day (BID) on day 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.~Capmatinib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
11360554|NCT02587650|FG001|Participant Flow|Arm B (Ceritinib)|"Patients with ALK fusion receive ceritinib PO once a day (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.~Ceritinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11360555|NCT02587650|FG002|Participant Flow|Arm C (Regorafenib)|"Patients with RET or BRAF fusion receive regorafenib PO QD on day 1-21. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.~Laboratory Biomarker Analysis: Correlative studies~Regorafenib: Given PO"
11360556|NCT02587650|FG003|Participant Flow|Arm D (Entrectinib)|"Patients with NTRK1, NTRK2, NTRK3, OR ROS1 fusion receive entrectinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.~Entrectinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11360557|NCT02587650|OG000|Outcome|Arm C (Regorafenib)|Patients with RET or BRAF mutations
11360558|NCT02587650|EG000|Reported Event|Arm C (Regorafenib)|Patients with RET or BRAF mutations
11360559|NCT02569957|BG000|Baseline|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
11360560|NCT02569957|BG001|Baseline|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
11360561|NCT02569957|BG002|Baseline|Total|Total of all reporting groups
11360562|NCT02569957|FG000|Participant Flow|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
11360563|NCT02569957|FG001|Participant Flow|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
11238944|NCT02466958|FG001|Participant Flow|Placebo|"All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.~Placebo: an inactive drug"
11238945|NCT02466958|OG000|Outcome|Levomilnacipran (FETZIMA)|"All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.~levomilnacipran: antidepressant"
11238946|NCT02466958|OG001|Outcome|Placebo|"All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.~Placebo: an inactive drug"
11238947|NCT02466958|EG000|Reported Event|Levomilnacipran (FETZIMA)|"All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.~levomilnacipran: antidepressant"
11238948|NCT02466958|EG001|Reported Event|Placebo|"All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.~Placebo: an inactive drug"
11238949|NCT02467075|BG000|Baseline|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
11238950|NCT02467075|BG001|Baseline|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
11238951|NCT02467075|BG002|Baseline|Total|Total of all reporting groups
11238952|NCT02467075|FG000|Participant Flow|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT. The function of the fluids is to minimize the effect of the contrast on their creatinine level.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
11238953|NCT02467075|FG001|Participant Flow|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT will be randomized to receive normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT. The fluids are given to placebo patients in order to minimize any differences in treatment between the treatment and placebo groups.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
11238954|NCT02467075|OG000|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
11238955|NCT02467075|OG001|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
11238956|NCT02467075|OG000|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
11238957|NCT02467075|OG001|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
11238958|NCT02467075|EG000|Reported Event|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
11238959|NCT02467075|EG001|Reported Event|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
11238960|NCT02467166|BG000|Baseline|Circa™ Probe|"The Circa™ Probe will be used during the RFCA to monitor esophageal temperature. Following ablation, the esophagoscopy will be performed to examine the esophagus for resulting thermal lesions.~Circa™ Probe: The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation esophagoscopy will be performed to assess for esophageal lesions."
11187851|NCT02109445|BG000|Baseline|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
11187852|NCT02109445|FG000|Participant Flow|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
11187853|NCT02109445|OG000|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
11187854|NCT02109445|EG000|Reported Event|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
11187855|NCT02109458|BG000|Baseline|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
11187856|NCT02109458|FG000|Participant Flow|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
11187857|NCT02109458|OG000|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
11187858|NCT02109458|EG000|Reported Event|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
11187859|NCT02109484|BG000|Baseline|Cohort A Placebo|Healthy toddlers aged 2 to < 3 years receiving placebo
11187860|NCT02109484|BG001|Baseline|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to < 3 years receiving low dose P2-VP8
11187861|NCT02109484|BG002|Baseline|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to < 3 years receiving Medium Dose Ps-VP9
11187862|NCT02109484|BG003|Baseline|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to < 3 years receiving High Dose P2-VP8
11187863|NCT02109484|BG004|Baseline|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placeblo
11187864|NCT02109484|BG005|Baseline|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
11187865|NCT02109484|BG006|Baseline|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
11187866|NCT02109484|BG007|Baseline|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
11187867|NCT02109484|BG008|Baseline|Total|Total of all reporting groups
11187868|NCT02109484|FG000|Participant Flow|Cohort A Placebo|Healthy toddlers aged 2 to <3 months receiving placebo
11187869|NCT02109484|FG001|Participant Flow|Cohort A 10 mcg P2-VP8|Healthy toddlers 2 to <3 yrs of age receiving low dose P2-VP8
11187870|NCT02109484|FG002|Participant Flow|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 yrs receiving an intermediate dose of P2-VP8
11187871|NCT02109484|FG003|Participant Flow|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to < 3 yrs receiving high dose P2-PV8
11187872|NCT02109484|FG004|Participant Flow|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
11187873|NCT02109484|FG005|Participant Flow|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving low dose P2-VP8
11187874|NCT02109484|FG006|Participant Flow|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks of age receiving a medium dose of P2-VP8
11187875|NCT02109484|FG007|Participant Flow|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving high dose of P2-VP8
11187876|NCT02109484|OG000|Outcome|Cohort A Placebo|Healthy toddlers aged 2 to <3 months receiving placebo
11187877|NCT02109484|OG001|Outcome|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving low dose P2-VP8
11187878|NCT02109484|OG002|Outcome|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving Medium Dose P2-VP8
11187879|NCT02109484|OG003|Outcome|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving placebo High Dose P2-VP8
11187880|NCT02109484|OG004|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
11187881|NCT02109484|OG005|Outcome|Cohort B 10 mcg P2-VP8|Healthy infants aged 6 to < 8 weeks receiving Low Dose P2-VP8
11187882|NCT02109484|OG006|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
11187883|NCT02109484|OG007|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
11187884|NCT02109484|OG000|Outcome|Cohort A Placebo|Healthy toddlers aged 2 to <3 years receiving Placebo
11187885|NCT02109484|OG001|Outcome|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving Low Dose P2-VP8
11238961|NCT02467166|FG000|Participant Flow|Circa™ Probe|"The Circa™ Probe will be used during the RFCA to monitor esophageal temperature. Following ablation, the esophagoscopy will be performed to examine the esophagus for resulting thermal lesions.~Circa™ Probe: The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation esophagoscopy will be performed to assess for esophageal lesions."
11238962|NCT02467166|OG000|Outcome|Circa™ Probe|Circa™ Probe: The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation, esophagoscopy will be performed to assess for any esophageal lesions. The first phase of the study consisted of patients who were to undergo esophagoscopy immediately after ablation and the second phase of the study in patients 24 hours after ablation.
11238963|NCT02467166|EG000|Reported Event|Circa™ Probe|"The Circa™ Probe will be used during the RFCA to monitor esophageal temperature. Following ablation, the esophagoscopy will be performed to examine the esophagus for resulting thermal lesions.~Circa™ Probe: The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation esophagoscopy will be performed to assess for esophageal lesions."
11238964|NCT02467179|BG000|Baseline|Manual Catheter Manipulation|"25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.~Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.~In this study, this group will be assigned to manual catheter manipulation."
11238965|NCT02467179|BG001|Baseline|Amigo™ Robotic Catheter Manipulation|"25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.~Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.~In this study, this group will be assigned to robotic catheter manipulation."
11238966|NCT02467179|BG002|Baseline|Total|Total of all reporting groups
11238967|NCT02467179|FG000|Participant Flow|Manual Catheter Manipulation|"25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.~Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.~In this study, this group will be assigned to manual catheter manipulation."
11238968|NCT02467179|FG001|Participant Flow|Amigo™ Robotic Catheter Manipulation|"25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.~Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.~In this study, this group will be assigned to robotic catheter manipulation."
11238969|NCT02467179|OG000|Outcome|Manual Catheter Manipulation|"25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.~Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.~In this study, this group will be assigned to manual catheter manipulation."
11238970|NCT02467179|OG001|Outcome|Amigo™ Robotic Catheter Manipulation|"25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.~Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.~In this study, this group will be assigned to robotic catheter manipulation."
11238971|NCT02467179|EG000|Reported Event|Manual Catheter Manipulation|"25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.~Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.~In this study, this group will be assigned to manual catheter manipulation."
11238972|NCT02467179|EG001|Reported Event|Amigo™ Robotic Catheter Manipulation|"25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.~Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.~In this study, this group will be assigned to robotic catheter manipulation."
11238973|NCT02467192|BG000|Baseline|Thoracic Low Dose CT|A LDCT scan, without administration of intra-venous contrast, was performed as soon as possible after the first Likert scale estimate, ideally within 24h of inclusion in the study, but no later than 72h.
11238974|NCT02467192|FG000|Participant Flow|Thoracic Low Dose CT|A LDCT scan, without administration of intra-venous contrast, was performed as soon as possible after the first Likert scale estimate, ideally within 24h of inclusion in the study, but no later than 72h.
11238975|NCT02467192|OG000|Outcome|Low Probability of Pneumonia After LDCT|Clinician's estimates of low probability of pneumonia after LDCT chest scan
11238976|NCT02467192|OG001|Outcome|Intermediate Probability of Pneumonia After LDCT|Clinician's estimates of Intermediate probability of pneumonia after LDCT chest scans
11238977|NCT02467192|OG002|Outcome|High Probability of Pneumonia After LDCT|Clinician's estimates of high probability of pneumonia after LDCT chest scan
11238978|NCT02467192|OG000|Outcome|With Pneumonia on LDCT|presence of pneumonia on a low-dose CT-scan as assessed by two independent expert radiologists
11238979|NCT02467192|OG001|Outcome|No Pneumonia on LDCT|Absence of pneumonia on a low-dose CT-scan as assessed by two independent expert radiologists
11238980|NCT02467192|EG000|Reported Event|Thoracic Low Dose CT|A LDCT scan, without administration of intra-venous contrast, was performed as soon as possible after the first Likert scale estimate, ideally within 24h of inclusion in the study, but no later than 72h.
11238981|NCT02467387|BG000|Baseline|Study Population|"itMSC, then Placebo: Participants first received itMSC 1.5 million per kilogram of weight, infused in the corresponding hospital facility at speed of 1 mL/minute (cell concentration 1 million/mL). After 90 days patients completed treatment at 90 days, and thus constituted the control treatment. After 90 day follow-up testing patients received Placebo and followed up for another 90 days. Total efficacy follow-up - 180 days. Safety follow-up - 240 days.~Placebo, then itMSC: Participants first received Placebo, infused in the corresponding hospital facility at speed of 1 mL/minute. After 90 days patients completed Placebo Control and related testing, and received itMSC treatment 1.5 million per kilogram of weight, and thus constituted the itMSC treated group for another 90 days.Total efficacy follow-up - 180 days. Safety follow-up - 240 days. and thus constituted the control treatment."
11238982|NCT02467387|FG000|Participant Flow|itMSC, Then Placebo|Participants first received itMSC 1.5 million per kilogram of weight, infused in the corresponding hospital facility at speed of 1 mL/minute (cell concentration 1 million/mL). After 90 days patients completed treatment at 90 days, and thus constituted the control treatment. After 90 day follow-up testing patients received Placebo and followed up for another 90 days. Total efficacy follow-up - 180 days. Safety measurements 0, 60, 90, days 270 and 450.
11238983|NCT02467387|FG001|Participant Flow|Placebo, Then itMSC|Participants first received Placebo, infused in the corresponding hospital facility at speed of 1 mL/minute. After 90 days patients completed Placebo Control and related testing, and received itMSC treatment 1.5 million per kilogram of weight, and thus constituted the itMSC treated group for another 90 days.Total efficacy follow-up - 180 days. Safety measurements 0, 60, 90, days 270 and 450.
11238984|NCT02467387|OG000|Outcome|Experimental|Participants received itMSC
11238985|NCT02467387|OG001|Outcome|Placebo|Participants received Placebo
11238986|NCT02467387|OG000|Outcome|Experimental: Human (itMSC)|"Intervention: One time intravenous infusion of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more.~Allogeneic Mesenchymal Bone Marrow Cells (itMSC): One time infusion Allogeneic Mesenchymal Bone Marrow Cells (itMSC) 1.5 million cells/kg."
11238987|NCT02467387|OG001|Outcome|Placebo:Lactated Ringer's Solution (LRS)|"Intervention: One time intravenous infusion of 1.5mL/kg Lactated Ringer's Solution (LRS) administered at a constant rate of approximately 2mL/min.~Lactated Ringer's Solution: One time infusion 1.5mL/kg"
11238988|NCT02467387|EG000|Reported Event|Experimental|Subjects that received experimental drug, 22 subjects
11238989|NCT02467387|EG001|Reported Event|Placebo|Subjects that received placebo, 20 subjects
11238990|NCT02467465|BG000|Baseline|Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.~Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.~Primary completion date is after January 2017."
11238991|NCT02467465|BG001|Baseline|Invasive Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles.~Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.~Primary completion date is after January 2017."
11238992|NCT02467465|BG002|Baseline|Total|Total of all reporting groups
11238993|NCT02467465|FG000|Participant Flow|Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.~Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles."
11238994|NCT02467465|FG001|Participant Flow|Invasive Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles.~Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles."
11238995|NCT02467465|OG000|Outcome|Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.~Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.~Primary completion date is after January 2017."
11238996|NCT02467465|OG001|Outcome|Invasive Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles.~Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.~Primary completion date is after January 2017."
11238997|NCT02467465|OG000|Outcome|Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.~Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles."
11238998|NCT02467465|OG001|Outcome|Invasive Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles.~Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles."
11238999|NCT02467465|EG000|Reported Event|Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.~Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles."
11239000|NCT02467465|EG001|Reported Event|Invasive Physical Therapy Modalities|"Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles.~Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles."
11239001|NCT02467491|BG000|Baseline|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
11341806|NCT03688620|EG000|Reported Event|Vaccinated_AlphaRix Tetra Group|Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
11360564|NCT02569957|OG000|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
11360565|NCT02569957|OG001|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
11360566|NCT02569957|EG000|Reported Event|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
11360567|NCT02569957|EG001|Reported Event|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
11360568|NCT02568007|BG000|Baseline|No Cyproheptadine Treatment|Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.
11360569|NCT02568007|BG001|Baseline|Continuous Cyproheptadine|"Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used.~Cyproheptadine"
11360570|NCT02568007|BG002|Baseline|Cycled Cyproheptadine|"Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for two weeks cycled with no cyproheptadine given for two weeks for a total of two months. Patients on cycled dosing will be given cyproheptadine for two weeks, then no medication for two weeks; repeating this cycle for the two month duration of study~Cyproheptadine"
11360571|NCT02568007|BG003|Baseline|Total|Total of all reporting groups
11360572|NCT02568007|FG000|Participant Flow|No Cyproheptadine Treatment|Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.
11360573|NCT02568007|FG001|Participant Flow|Continuous Cyproheptadine|"Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used.~Cyproheptadine"
11360574|NCT02568007|FG002|Participant Flow|Cycled Cyproheptadine|"Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for two weeks cycled with no cyproheptadine given for two weeks for a total of two months. Patients on cycled dosing will be given cyproheptadine for two weeks, then no medication for two weeks; repeating this cycle for the two month duration of study~Cyproheptadine"
11360575|NCT02568007|OG000|Outcome|No Cyproheptadine Treatment|Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.
11360576|NCT02568007|OG001|Outcome|Continuous Cyproheptadine|"Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used.~Cyproheptadine"
11360577|NCT02568007|OG002|Outcome|Cycled Cyproheptadine|"Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for two weeks cycled with no cyproheptadine given for two weeks for a total of two months. Patients on cycled dosing will be given cyproheptadine for two weeks, then no medication for two weeks; repeating this cycle for the two month duration of study~Cyproheptadine"
11360578|NCT02568007|EG000|Reported Event|No Cyproheptadine Treatment|Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.
11360579|NCT02568007|EG001|Reported Event|Continuous Cyproheptadine|"Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used.~Cyproheptadine"
11360580|NCT02568007|EG002|Reported Event|Cycled Cyproheptadine|"Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for two weeks cycled with no cyproheptadine given for two weeks for a total of two months. Patients on cycled dosing will be given cyproheptadine for two weeks, then no medication for two weeks; repeating this cycle for the two month duration of study~Cyproheptadine"
11360581|NCT02575365|BG000|Baseline|Fingolimod Arm|0.5 mg p.o fingolimod daily
11360582|NCT02575365|FG000|Participant Flow|Fingolimod Arm|0.5 mg p.o fingolimod daily
11360583|NCT02575365|OG000|Outcome|Fingolimod Arm|0.5 mg p.o fingolimod daily
11360584|NCT02575365|EG000|Reported Event|Fingolimod Arm|0.5 mg p.o fingolimod daily
11360585|NCT02549755|BG000|Baseline|Radiotherapy Treatment Monitoring of Hepatocellular Carcinoma|"All patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points.~11C-Acetate: The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).~There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient"
11360586|NCT02549755|FG000|Participant Flow|Main Arm|Enrolled patients are to undergo 3 acetate PET/CT examinations--the first within one month prior to radiotherapy, the second one month following, and the third three months following radiotherapy.
11360587|NCT02549755|OG000|Outcome|Main Arm|The single patient enrolled in the trial did not show tumor uptake on the initial scan and was thus dropped from the trial. The study was terminated in November of 2016.
11187886|NCT02109484|OG002|Outcome|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving Medium Dose P2-VP8
11187887|NCT02109484|OG003|Outcome|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving High Dose P2-VP8
11360588|NCT02549755|EG000|Reported Event|Main Arm|No adverse events occurred during the trial.
11360589|NCT02547129|BG000|Baseline|Static Antibiotic Spacer|Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
11360590|NCT02547129|BG001|Baseline|Articulating Antibiotic Spacer|Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
11360591|NCT02547129|BG002|Baseline|Total|Total of all reporting groups
11360592|NCT02547129|FG000|Participant Flow|Static Antibiotic Spacer|Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
11360593|NCT02547129|FG001|Participant Flow|Articulating Antibiotic Spacer|Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
11360594|NCT02547129|OG000|Outcome|Static Antibiotic Spacer|Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
11360595|NCT02547129|OG001|Outcome|Articulating Antibiotic Spacer|Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
11360596|NCT02547129|EG000|Reported Event|Static Antibiotic Spacer|Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
11360597|NCT02547129|EG001|Reported Event|Articulating Antibiotic Spacer|Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
11360598|NCT02528097|BG000|Baseline|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
11360599|NCT02528097|BG001|Baseline|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
11360600|NCT02528097|BG002|Baseline|Total|Total of all reporting groups
11360601|NCT02528097|FG000|Participant Flow|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
11360602|NCT02528097|FG001|Participant Flow|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
10962119|NCT00864916|FG000|Participant Flow|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
11187888|NCT02109484|OG004|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving Placebo
11360603|NCT02528097|OG000|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
11360604|NCT02528097|OG001|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
11360605|NCT02528097|EG000|Reported Event|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
11187889|NCT02109484|OG005|Outcome|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
11376242|NCT01177540|EG000|Reported Event|Treatment A: Decitabine + Induction Chemotherapy|Participants received decitabine 20 mg/m^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
11187890|NCT02109484|OG001|Outcome|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving Low Dose Toddlers P2-VP8
11187891|NCT02109484|OG003|Outcome|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving High Dose P2-VP8
11187892|NCT02109484|OG007|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose Infants P2-VP8
11187893|NCT02109484|OG000|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
11187894|NCT02109484|OG001|Outcome|Cohort B 10 mcg P2-VP8|Healthy infants aged 6 to <8 weeks receiving low dose P2-VP8
11187895|NCT02109484|OG002|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
11187896|NCT02109484|OG003|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
11187897|NCT02109484|OG001|Outcome|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
11187898|NCT02109484|OG002|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8 Medium Dose Infants
11187899|NCT02109484|OG001|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
11187900|NCT02109484|OG002|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
11187901|NCT02109484|EG000|Reported Event|Cohort A Placebo|Healthy toddlers aged 2 to <3 years receiving Placebo
11187902|NCT02109484|EG001|Reported Event|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving Low Dose P2-VP8
11187903|NCT02109484|EG002|Reported Event|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving Medium Dose P2-VP8
11187904|NCT02109484|EG003|Reported Event|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving High Dose P2-VP8
11187905|NCT02109484|EG004|Reported Event|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
11187906|NCT02109484|EG005|Reported Event|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
11187907|NCT02109484|EG006|Reported Event|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
11187908|NCT02109484|EG007|Reported Event|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
11187909|NCT02109497|BG000|Baseline|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
11187910|NCT02109497|FG000|Participant Flow|Caffeine Dosing|Single dose of caffeine 100 mg administered on Day 1 and Day 12 with PBT2 250 mg administered from Day 8 to 12.
11187911|NCT02109497|OG000|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
11187912|NCT02109497|EG000|Reported Event|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
11187913|NCT02109562|BG000|Baseline|RBP-7000 90 mg|Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
11187914|NCT02109562|BG001|Baseline|RBP-7000 120 mg|Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
11187915|NCT02109562|BG002|Baseline|Placebo|Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections.
11187916|NCT02109562|BG003|Baseline|Total|Total of all reporting groups
11187917|NCT02109562|FG000|Participant Flow|RBP-7000 90 mg|Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
11187918|NCT02109562|FG001|Participant Flow|RBP-7000 120 mg|Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
11187919|NCT02109562|FG002|Participant Flow|Placebo|Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections.
11187920|NCT02109562|OG000|Outcome|RBP-7000 90 mg|Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
11187921|NCT02109562|OG001|Outcome|RBP-7000 120 mg|Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
11187922|NCT02109562|OG002|Outcome|Placebo|Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections.
11187923|NCT02109562|EG000|Reported Event|RBP-7000 90 mg|Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
11187924|NCT02109562|EG001|Reported Event|RBP-7000 120 mg|Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
11187925|NCT02109562|EG002|Reported Event|Placebo|Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections.
11187926|NCT02109640|BG000|Baseline|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
11187927|NCT02109640|BG001|Baseline|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
11187928|NCT02109640|BG002|Baseline|Total|Total of all reporting groups
11187929|NCT02109640|FG000|Participant Flow|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
11187930|NCT02109640|FG001|Participant Flow|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
11187931|NCT02109640|OG000|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
11360606|NCT02528097|EG001|Reported Event|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
11360607|NCT02549716|BG000|Baseline|IV Acetaminophen + Oral Placebo|"Patients in this group will receive IV acetaminophen and an oral placebo. The IV formulation will be given using the FDA approved OFIRMEV which comes in a single glass bottle at a concentration of 1000mg/100ml (10mg/ml) containing a total of 1 gram of acetaminophen.~IV acetaminophen: Patients in this group will receive IV acetaminophen and an oral placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.~Oral placebo: Patients who receive IV acetaminophen will also receive an oral placebo with their IV treatments (every 6 hours for a 14 day period)."
11360608|NCT02549716|BG001|Baseline|Oral Acetaminophen + IV Placebo|"Patients in this group will receive oral acetaminophen and a saline solution placebo through their IV. The enteral formulation will be in the standard tablet form of 500mg per pill. Patients will receive two pills, or 1 gram of acetaminophen.~Oral acetaminophen: Patients in this group will receive oral acetaminophen and an IV saline solution placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.~IV placebo: Patients who receive oral acetaminophen will also receive a saline solution placebo at the same time that they receive the oral acetaminophen treatment (every 6 hours for 14 days)."
11360609|NCT02549716|BG002|Baseline|Total|Total of all reporting groups
11360610|NCT02549716|FG000|Participant Flow|IV Acetaminophen + Oral Placebo|"Patients in this group will receive IV acetaminophen and an oral placebo. The IV formulation will be given using the FDA approved OFIRMEV which comes in a single glass bottle at a concentration of 1000mg/100ml (10mg/ml) containing a total of 1 gram of acetaminophen.~IV acetaminophen: Patients in this group will receive IV acetaminophen and an oral placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.~Oral placebo: Patients who receive IV acetaminophen will also receive an oral placebo with their IV treatments (every 6 hours for a 14 day period)."
11360611|NCT02549716|FG001|Participant Flow|Oral Acetaminophen + IV Placebo|"Patients in this group will receive oral acetaminophen and a saline solution placebo through their IV. The enteral formulation will be in the standard tablet form of 500mg per pill. Patients will receive two pills, or 1 gram of acetaminophen.~Oral acetaminophen: Patients in this group will receive oral acetaminophen and an IV saline solution placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.~IV placebo: Patients who receive oral acetaminophen will also receive a saline solution placebo at the same time that they receive the oral acetaminophen treatment (every 6 hours for 14 days)."
11360612|NCT02549716|OG000|Outcome|IV Acetaminophen + Oral Placebo|"Patients in this group will receive IV acetaminophen and an oral placebo. The IV formulation will be given using the FDA approved OFIRMEV which comes in a single glass bottle at a concentration of 1000mg/100ml (10mg/ml) containing a total of 1 gram of acetaminophen.~IV acetaminophen: Patients in this group will receive IV acetaminophen and an oral placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.~Oral placebo: Patients who receive IV acetaminophen will also receive an oral placebo with their IV treatments (every 6 hours for a 14 day period)."
11360613|NCT02549716|OG001|Outcome|Oral Acetaminophen + IV Placebo|"Patients in this group will receive oral acetaminophen and a saline solution placebo through their IV. The enteral formulation will be in the standard tablet form of 500mg per pill. Patients will receive two pills, or 1 gram of acetaminophen.~Oral acetaminophen: Patients in this group will receive oral acetaminophen and an IV saline solution placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.~IV placebo: Patients who receive oral acetaminophen will also receive a saline solution placebo at the same time that they receive the oral acetaminophen treatment (every 6 hours for 14 days)."
11360614|NCT02549716|EG000|Reported Event|IV Acetaminophen + Oral Placebo|"Patients in this group will receive IV acetaminophen and an oral placebo. The IV formulation will be given using the FDA approved OFIRMEV which comes in a single glass bottle at a concentration of 1000mg/100ml (10mg/ml) containing a total of 1 gram of acetaminophen.~IV acetaminophen: Patients in this group will receive IV acetaminophen and an oral placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.~Oral placebo: Patients who receive IV acetaminophen will also receive an oral placebo with their IV treatments (every 6 hours for a 14 day period)."
11360615|NCT02549716|EG001|Reported Event|Oral Acetaminophen + IV Placebo|"Patients in this group will receive oral acetaminophen and a saline solution placebo through their IV. The enteral formulation will be in the standard tablet form of 500mg per pill. Patients will receive two pills, or 1 gram of acetaminophen.~Oral acetaminophen: Patients in this group will receive oral acetaminophen and an IV saline solution placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.~IV placebo: Patients who receive oral acetaminophen will also receive a saline solution placebo at the same time that they receive the oral acetaminophen treatment (every 6 hours for 14 days)."
11360616|NCT02540434|BG000|Baseline|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
11239002|NCT02467491|FG000|Participant Flow|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
11239003|NCT02467491|OG000|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
11239004|NCT02467491|EG000|Reported Event|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
11239005|NCT02467504|BG000|Baseline|Experimental|"hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen~hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)~MTX: Methotrexate (oral administration)~Folic Acid: Folic Acid (oral administration)~Loxoprofen: Loxoprofen (oral administration)"
11239006|NCT02467504|BG001|Baseline|Placebo Comparator|"hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen~hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)~MTX: Methotrexate (oral administration)~Folic Acid: Folic Acid (oral administration)~Loxoprofen: Loxoprofen (oral administration)"
11239007|NCT02467504|BG002|Baseline|Total|Total of all reporting groups
11239008|NCT02467504|FG000|Participant Flow|Experimental|"hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen~hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)~MTX: Methotrexate (oral administration)~Folic Acid: Folic Acid (oral administration)~Loxoprofen: Loxoprofen (oral administration)"
11239009|NCT02467504|FG001|Participant Flow|Placebo Comparator|"hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen~hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)~MTX: Methotrexate (oral administration)~Folic Acid: Folic Acid (oral administration)~Loxoprofen: Loxoprofen (oral administration)"
11239010|NCT02467504|OG000|Outcome|Experimental|"hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen~hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)~MTX: Methotrexate (oral administration)~Folic Acid: Folic Acid (oral administration)~Loxoprofen: Loxoprofen (oral administration)"
11239011|NCT02467504|OG001|Outcome|Placebo Comparator|"hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen~hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)~MTX: Methotrexate (oral administration)~Folic Acid: Folic Acid (oral administration)~Loxoprofen: Loxoprofen (oral administration)"
11239012|NCT02467504|EG000|Reported Event|Experimental|"hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen~hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)~MTX: Methotrexate (oral administration)~Folic Acid: Folic Acid (oral administration)~Loxoprofen: Loxoprofen (oral administration)"
11239013|NCT02467504|EG001|Reported Event|Placebo Comparator|"hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen~hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)~MTX: Methotrexate (oral administration)~Folic Acid: Folic Acid (oral administration)~Loxoprofen: Loxoprofen (oral administration)"
11239014|NCT02467621|BG000|Baseline|Proton Pump Inhibitor (PPI)|"Pantoprazole 40 mg~Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge"
11239015|NCT02467621|BG001|Baseline|Normal Saline|"Saline (0.9%)~Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge"
11239016|NCT02467621|BG002|Baseline|Total|Total of all reporting groups
11239017|NCT02467621|FG000|Participant Flow|Proton Pump Inhibitor (PPI)|"Pantoprazole 40 mg~Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge"
11239018|NCT02467621|FG001|Participant Flow|Normal Saline|"Saline (0.9%)~Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge"
11239019|NCT02467621|OG000|Outcome|Proton Pump Inhibitor (PPI)|"Pantoprazole 40 mg~Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge"
11239020|NCT02467621|OG001|Outcome|Normal Saline|"Saline (0.9%)~Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge"
11239021|NCT02467621|EG000|Reported Event|Proton Pump Inhibitor (PPI)|"Pantoprazole 40 mg~Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge"
11239022|NCT02467621|EG001|Reported Event|Normal Saline|"Saline (0.9%)~Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge"
11239023|NCT02467777|BG000|Baseline|Forced Air|"Bair Hugger~Bair Hugger"
11239024|NCT02467777|BG001|Baseline|Conductive Warming|"VitaHeat~VitaHeat"
11239025|NCT02467777|BG002|Baseline|Total|Total of all reporting groups
11239026|NCT02467777|FG000|Participant Flow|Forced Air|"Bair Hugger~Bair Hugger"
11239027|NCT02467777|FG001|Participant Flow|Conductive Warming|"VitaHeat~VitaHeat"
11239028|NCT02467777|OG000|Outcome|Forced Air|"Bair Hugger~Bair Hugger"
11239029|NCT02467777|OG001|Outcome|Conductive Warming|"VitaHeat~VitaHeat"
11239030|NCT02467777|EG000|Reported Event|Forced Air|"Bair Hugger~Bair Hugger"
11239031|NCT02467777|EG001|Reported Event|Conductive Warming|"VitaHeat~VitaHeat"
11239032|NCT02467842|BG000|Baseline|NBP607-QIV|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria"
11239033|NCT02467842|BG001|Baseline|NBP607-Y|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-Y: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata"
11239034|NCT02467842|BG002|Baseline|NBP607-V|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-V: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria"
11239035|NCT02467842|BG003|Baseline|Total|Total of all reporting groups
11239036|NCT02467842|FG000|Participant Flow|NBP607-QIV|"Participants received a 0.5mL single intramuscular dose on Day 0~NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria"
11239037|NCT02467842|FG001|Participant Flow|NBP607-Y|"Participants received a 0.5mL single intramuscular dose on Day 0~NBP607-Y: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata"
11239038|NCT02467842|FG002|Participant Flow|NBP607-V|"Participants received a 0.5mL single intramuscular dose on Day 0~NBP607-V: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria"
11239039|NCT02467842|OG000|Outcome|NBP607-QIV|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria"
11239040|NCT02467842|OG001|Outcome|NBP607-Y|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-Y: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata"
11239041|NCT02467842|OG002|Outcome|NBP607-V|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-V: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria"
11239042|NCT02467842|OG000|Outcome|NBP607-QIV|"Participants aged 60 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria"
11239043|NCT02467842|OG000|Outcome|NBP607-QIV|"Participants aged 19 to 59 years received a 0.5mL single intramuscular dose on Day 0~NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria"
11239044|NCT02467842|EG000|Reported Event|NBP607-QIV|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria"
11239045|NCT02467842|EG001|Reported Event|NBP607-Y|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-Y: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata"
11239046|NCT02467842|EG002|Reported Event|NBP607-V|"Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0~NBP607-V: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria"
11239047|NCT02468154|BG000|Baseline|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
11239048|NCT02468154|BG001|Baseline|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
11239049|NCT02468154|BG002|Baseline|Total|Total of all reporting groups
11239050|NCT02468154|FG000|Participant Flow|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
11239051|NCT02468154|FG001|Participant Flow|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
11239052|NCT02468154|OG000|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
11239053|NCT02468154|OG001|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
11239054|NCT02468154|EG000|Reported Event|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
11239055|NCT02468154|EG001|Reported Event|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
11239056|NCT02468193|BG000|Baseline|Osilodrostat|Patients in this arm took the study drug, osilodrostat.
11187932|NCT02109640|OG001|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
11360617|NCT02540434|BG001|Baseline|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
11360618|NCT02540434|BG002|Baseline|Total|Total of all reporting groups
11360619|NCT02540434|FG000|Participant Flow|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
11360620|NCT02540434|FG001|Participant Flow|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
11360621|NCT02540434|OG000|Outcome|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
11360622|NCT02540434|OG001|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
11360623|NCT02540434|OG001|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cry"
11360624|NCT02540434|OG001|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
11187933|NCT02109640|EG000|Reported Event|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
11187934|NCT02109640|EG001|Reported Event|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
11239057|NCT02468193|FG000|Participant Flow|Osilodrostat|Patients in this arm took the study drug, osilodrostat.
11239058|NCT02468193|OG000|Outcome|Osilodrostat|Patients in this arm took the study drug, osilodrostat.
11239059|NCT02468193|OG000|Outcome|ACTH|Adrenocorticotropic hormone
11239060|NCT02468193|OG001|Outcome|Serum 11-deoxycorticosterone|adrenal steroid hormones: Serum 11-deoxycorticosterone
11239061|NCT02468193|OG002|Outcome|Aldosterone|adrenal steroid hormones: Aldosterone
11239062|NCT02468193|OG003|Outcome|Estradiol|adrenal steroid hormones: Estradiol
11239063|NCT02468193|OG000|Outcome|Serum 11-deoxycortisol|adrenal steroid hormones: Serum 11-deoxycortisol
11239064|NCT02468193|OG001|Outcome|Testosterone|adrenal steroid hormones: Testosterone
11239065|NCT02468193|OG000|Outcome|Cholesterol|Patients in this arm took the study drug, osilodrostat.
11239066|NCT02468193|OG001|Outcome|HDL Cholesterol|Patients in this arm took the study drug, osilodrostat.
11239067|NCT02468193|OG002|Outcome|LDL Cholesterol|Patients in this arm took the study drug, osilodrostat.
11239068|NCT02468193|OG003|Outcome|Triglycerides|Patients in this arm took the study drug, osilodrostat.
11239069|NCT02468193|OG000|Outcome|Sitting Systolic BP|Patients in this arm took the study drug, osilodrostat.
11239070|NCT02468193|OG001|Outcome|Sitting Diastolic BP|Patients in this arm took the study drug, osilodrostat.
11239071|NCT02468193|OG000|Outcome|Osilodrostat 1mg|Patients in this arm took 1mg of study drug, osilodrostat.
10962120|NCT00864916|FG001|Participant Flow|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
11239072|NCT02468193|OG001|Outcome|Osilodrostat 2mg|Patients in this arm took 2mg of study drug, osilodrostat.
11376243|NCT01177540|EG001|Reported Event|Treatment B: Induction Chemotherapy Only|Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
11239073|NCT02468193|OG002|Outcome|Osilodrostat 3mg|Patients in this arm took 3mg of study drug, osilodrostat.
11239074|NCT02468193|OG003|Outcome|Osilodrostat 5mg|Patients in this arm took 5mg of study drug, osilodrostat.
11239075|NCT02468193|EG000|Reported Event|Osilodrostat|Patients in this arm took the study drug, osilodrostat.
11239076|NCT02468557|BG000|Baseline|Idelalisib 150 mg|Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
11239077|NCT02468557|FG000|Participant Flow|Idelalisib 150 mg|Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
11239078|NCT02468557|OG000|Outcome|Idelalisib 150 mg|Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
11239079|NCT02468557|OG000|Outcome|Idelalisib + Nab-paclitaxel|Participants were to be administered IDL tablets orally twice daily plus nab-paclitaxel administered intravenously on Days 1, 8 and 15 of each 28 day cycle.
11239080|NCT02468557|OG001|Outcome|Idelalisib + mFOLFOX6|Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
11239081|NCT02468557|OG001|Outcome|Idelalisib + Nab-paclitaxel|Participants were to be administered IDL tablets orally twice daily plus nab-paclitaxel administered intravenously on Days 1, 8 and 15 of each 28 day cycle.
11239082|NCT02468557|OG002|Outcome|Idelalisib + mFOLFOX6|Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
11239083|NCT02468557|EG000|Reported Event|Idelalisib 150 mg|Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
11239084|NCT02468570|BG000|Baseline|Pooled Active|Subjects randomized to receive active drug in study 165-302 part 2
11239085|NCT02468570|BG001|Baseline|Pooled Placebo|Subjects randomized to receive placebo in study 165-302 part 2
11239086|NCT02468570|BG002|Baseline|Total|Total of all reporting groups
11239087|NCT02468570|FG000|Participant Flow|Pooled Active|Subjects randomized to receive active drug in study 165-302 part 2
11239088|NCT02468570|FG001|Participant Flow|Pooled Placebo|Subjects randomized to receive placebo in study 165-302 part 2
11239089|NCT02468570|OG000|Outcome|Pooled Active|Subjects randomized to receive active drug in study 165-302 part 2
11239090|NCT02468570|OG001|Outcome|Pooled Placebo|Subjects randomized to receive placebo in study 165-302 part 2
11239091|NCT02468570|EG000|Reported Event|Pooled Active|Subjects randomized to receive active drug in study 165-302 part 2.
11239092|NCT02468570|EG001|Reported Event|Pooled Placebo|Subjects randomized to receive placebo in study 165-302 part 2
11239093|NCT02468648|BG000|Baseline|Combination of Sofosbuvir and GS-5816|"Combination of sofosbuvir and GS-5816 agent into a single pill will be used.~Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection~GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus."
11239094|NCT02468648|FG000|Participant Flow|Combination of Sofosbuvir and GS-5816|"Combination of sofosbuvir and GS-5816 agent into a single pill will be used.~Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection~GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus."
11239095|NCT02468648|OG000|Outcome|Combination of Sofosbuvir and GS-5816|"Combination of sofosbuvir and GS-5816 agent into a single pill will be used.~Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection~GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus."
11239096|NCT02468648|EG000|Reported Event|Combination of Sofosbuvir and GS-5816|"Combination of sofosbuvir and GS-5816 agent into a single pill will be used.~Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection~GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus."
11376244|NCT01038778|BG000|Baseline|Dose Level 1|Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11187935|NCT02109731|BG000|Baseline|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
11187936|NCT02109731|FG000|Participant Flow|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
11187937|NCT02109731|OG000|Outcome|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
11187938|NCT02109731|EG000|Reported Event|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
11187939|NCT02109939|BG000|Baseline|GeneSight Psychotropic Tested|"Subjects being tested with GeneSight Psychotropic~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
11187940|NCT02109939|BG001|Baseline|Treatment As Usual|"This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
11187941|NCT02109939|BG002|Baseline|Total|Total of all reporting groups
11187942|NCT02109939|FG000|Participant Flow|GeneSight Psychotropic Tested|"Subjects being tested with GeneSight Psychotropic~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
11187943|NCT02109939|FG001|Participant Flow|Treatment As Usual|"This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
11187944|NCT02109939|OG000|Outcome|Treatment As Usual|"This group of subjects will not have treatment guided by their GeneSight results or know whether they are in a particular arm.~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes. Tricyclic antidepressants, one MAOI, and typical and atypical antipsychotics are also represented."
11187945|NCT02109939|OG001|Outcome|GeneSight Psychotropic Tested|"Subjects being tested with GeneSight Psychotropic. This group of subjects will not know whether they are in a particular arm.~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes. Tricyclic antidepressants, one MAOI, and typical and atypical antipsychotics are also represented."
11376245|NCT01038778|BG001|Baseline|Dose Level 2|Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11376246|NCT01038778|BG002|Baseline|Total|Total of all reporting groups
11376247|NCT01038778|FG000|Participant Flow|Phase I Dose Level 1|Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11187946|NCT02109939|OG000|Outcome|GeneSight Psychotropic Tested|"Subjects being tested with GeneSight Psychotropic. This group of subjects will not know whether they are in a particular arm.~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes. Tricyclic antidepressants, one MAOI, and typical and atypical antipsychotics are also represented."
11187947|NCT02109939|OG001|Outcome|Treatment As Usual|"This group of subjects will not have treatment guided by their GeneSight results or know whether they are in a particular arm.~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes. Tricyclic antidepressants, one MAOI, and typical and atypical antipsychotics are also represented."
11187948|NCT02109939|OG000|Outcome|GeneSight Psychotropic Tested|"Subjects being tested with GeneSight Psychotropic~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
11187949|NCT02109939|OG001|Outcome|Treatment As Usual|"This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
11187950|NCT02109939|EG000|Reported Event|GeneSight Psychotropic Tested|"Subjects being tested with GeneSight Psychotropic~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
11187951|NCT02109939|EG001|Reported Event|Treatment As Usual|"This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.~GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
11187952|NCT02110095|BG000|Baseline|Picosure Laser System|"Picosure Laser System for the treatment of unwanted tattoos~Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos"
11187953|NCT02110095|FG000|Participant Flow|Picosure Laser System|"Picosure Laser System for the treatment of unwanted tattoos~Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos"
11376248|NCT01038778|FG001|Participant Flow|Phase I Dose Level 2|Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11187954|NCT02110095|OG000|Outcome|Picosure Laser System|"Picosure Laser System for the treatment of unwanted tattoos~Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos"
11187955|NCT02110095|EG000|Reported Event|Picosure Laser System|"Picosure Laser System for the treatment of unwanted tattoos~Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos"
11187956|NCT02110108|BG000|Baseline|Revlite Laser System|"Revlite Laser System~Revlite Laser System: Revlite Laser System for the Treatment of Facial Solar Lentigines"
11187957|NCT02110108|FG000|Participant Flow|Revlite Laser System|"Revlite Laser System~Revlite Laser System: Revlite Laser System with ½ of the face treated with the 1064nm wavelength and the other half of the face treated with combination of both the 1064nm and 532nm wavelengths."
11187958|NCT02110108|OG000|Outcome|Revlite Laser System Single|Revlite Laser System using just 1064 nm wavelength
11187959|NCT02110108|OG001|Outcome|Revlite Laser System- Combo|Revlite Laser System using 1064 nm and 532 nm wavelengths
11187960|NCT02110108|OG000|Outcome|Revlite Laser System- Single|Revlite Laser System with just 1064 nm wavelength used.
11187961|NCT02110108|OG001|Outcome|Revlite Laser System- Combo|Revlite Laser System with both 1064 nm and 532 nm used.
11187962|NCT02110108|EG000|Reported Event|Revlite Laser System Single|"Revlite Laser System~Revlite Laser System 1064nm wavelength"
11376249|NCT01038778|FG002|Participant Flow|Phase 2 Dose Level 2|Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11376250|NCT01038778|OG000|Outcome|Dose Level 1|Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11360625|NCT02540434|EG000|Reported Event|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities. Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate.~Only enrolled patients randomized to cryoprecipitate arm are at risk for cryoprecipitate-related adverse events. 1 subject out of total 22 consented were randomized to this arm, so 1 subject was at risk to adverse events from this arm. No events were reported."
11360626|NCT02540434|EG001|Reported Event|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen.~Only enrolled patients randomized to RiaSTAP are at risk for riastap-related adverse events. 0 subjects out of total 22 consented were randomized to this arm, so no subjects were at risk to adverse events from this arm."
11360627|NCT02531308|BG000|Baseline|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
11360628|NCT02531308|FG000|Participant Flow|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.~Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.~Rituximab: monoclonal antibody against protein CD20~Cyclophosphamide: Interferes with DNA replication~Doxorubicin: anthracycline antitumor antibiotic~Vincristine: Inhibits cell mitosis causing cell death.~Prednisone: a synthetic cortic"
11360629|NCT02531308|OG000|Outcome|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
11360630|NCT02531308|EG000|Reported Event|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.~Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.~Rituximab: monoclonal antibody against protein CD20~Cyclophosphamide: Interferes with DNA replication~Doxorubicin: anthracycline antitumor antibiotic~Vincristine: Inhibits cell mitosis causing cell death.~Prednisone: a synthetic cortic"
11360631|NCT02533531|BG000|Baseline|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
11360632|NCT02533531|FG000|Participant Flow|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
11360633|NCT02533531|OG000|Outcome|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
11360634|NCT02533531|EG000|Reported Event|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
11360635|NCT02534038|BG000|Baseline|AVP-786; Placebo|In Period 1, participants were randomized to receive AVP-786 (deuterated [d6]-dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) once a day (OD) in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 twice a day (BID) for 14 days. From Day 22, participants received a target dose of d6-DM 28 milligrams (mg)/Q 4.9 mg (AVP-786-28/4.9) BID for the remaining 3 weeks of Period 1. In Period 2, participants were randomized to receive matching placebo. The periods were separated by a 2-week washout period.
11360636|NCT02534038|BG001|Baseline|Placebo; AVP-786|In Period 1, participants were randomized to receive matching placebo. In Period 2, participants were randomized to receive AVP-786 OD in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 BID for 14 days. From Day 22, participants received a target dose of AVP-786-28/4.9 BID for the remaining 3 weeks of Period 2. The periods were separated by a 2-week washout period.
11360637|NCT02534038|BG002|Baseline|Total|Total of all reporting groups
11376251|NCT01038778|OG001|Outcome|Dose Level 2|Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11239097|NCT02468674|BG000|Baseline|Population I: BYM338 700 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239098|NCT02468674|BG001|Baseline|Population I BYM338: 700 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239099|NCT02468674|BG002|Baseline|Population I: BYM338 210 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239100|NCT02468674|BG003|Baseline|Population I BYM338: 210 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239101|NCT02468674|BG004|Baseline|Population I: BYM338 70 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239102|NCT02468674|BG005|Baseline|Population I: BYM338 70 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239103|NCT02468674|BG006|Baseline|Population I: Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239104|NCT02468674|BG007|Baseline|Population: II BYM338 700 mg|Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
11239105|NCT02468674|BG008|Baseline|Population: II Placebo|Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
11239106|NCT02468674|BG009|Baseline|Total|Total of all reporting groups
11239107|NCT02468674|FG000|Participant Flow|Population I: BYM338 700 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239108|NCT02468674|FG001|Participant Flow|Population I BYM338: 700 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239109|NCT02468674|FG002|Participant Flow|Population I: BYM338 210 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239110|NCT02468674|FG003|Participant Flow|Population I BYM338: 210 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239111|NCT02468674|FG004|Participant Flow|Population I: BYM338 70 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239112|NCT02468674|FG005|Participant Flow|Population I: BYM338 70 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239113|NCT02468674|FG006|Participant Flow|Population I: Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239114|NCT02468674|FG007|Participant Flow|Population: II BYM338 700 mg|Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
11239115|NCT02468674|FG008|Participant Flow|Population: II Placebo|Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
11239116|NCT02468674|OG000|Outcome|Population I: BYM338 700 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239117|NCT02468674|OG001|Outcome|Population I BYM338: 700 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239118|NCT02468674|OG002|Outcome|Population I: BYM338 210 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239119|NCT02468674|OG003|Outcome|Population I BYM338: 210 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239120|NCT02468674|OG004|Outcome|Population I: BYM338 70 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239121|NCT02468674|OG005|Outcome|Population I: BYM338 70 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239122|NCT02468674|OG006|Outcome|Population I: Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11187963|NCT02110108|EG001|Reported Event|Revlite Laser System Combo|"Revlite Laser System~Revlite Laser System: Combination of both the 1064nm and 532nm wavelengths"
11187964|NCT02110121|BG000|Baseline|Picosure Laser System|"Picosure Laser System for the Treatment of Unwanted Tattoos~Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos"
11187965|NCT02110121|BG001|Baseline|Revlite Laser System|"Revlite Laser System for the Treatment of Unwanted Tattoos~Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos"
11187966|NCT02110121|BG002|Baseline|Total|Total of all reporting groups
11187967|NCT02110121|FG000|Participant Flow|Picosure Laser System|"Picosure Laser System for the Treatment of Unwanted Tattoos~Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos"
11187968|NCT02110121|FG001|Participant Flow|Revlite Laser System|"Revlite Laser System for the Treatment of Unwanted Tattoos~Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos"
11187969|NCT02110121|OG000|Outcome|Picosure Laser System|"Picosure Laser System for the Treatment of Unwanted Tattoos~Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos"
11187970|NCT02110121|OG001|Outcome|Revlite Laser System|"Revlite Laser System for the Treatment of Unwanted Tattoos~Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos"
11187971|NCT02110121|EG000|Reported Event|Picosure Laser System|"Picosure Laser System for the Treatment of Unwanted Tattoos~Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos"
11187972|NCT02110121|EG001|Reported Event|Revlite Laser System|"Revlite Laser System for the Treatment of Unwanted Tattoos~Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos"
11187973|NCT02110147|BG000|Baseline|Single Arm|All patients were treated with uridine triacetate oral granules.
11187974|NCT02110147|FG000|Participant Flow|Single Arm|All patients were treated with uridine triacetate oral granules.
11187975|NCT02110147|OG000|Outcome|Uridine Triacetate|All patients were treated with uridine triacetate oral granules.
11187976|NCT02110147|EG000|Reported Event|Single Arm|All patients were treated with uridine triacetate oral granules.
11187977|NCT02110225|BG000|Baseline|rhNGF 60µg/ml|"rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes~rhNGF 60 µg/ml eye drops solution: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187978|NCT02110225|BG001|Baseline|rhNGF 180 µg/ml|"rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes.~rhNGF 180 µg/ml eye drops solution: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187979|NCT02110225|BG002|Baseline|Vehicle|"Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes.~Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187980|NCT02110225|BG003|Baseline|Total|Total of all reporting groups
11187981|NCT02110225|FG000|Participant Flow|rhNGF 60µg/ml|"rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes~rhNGF 60 µg/ml eye drops solution: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187982|NCT02110225|FG001|Participant Flow|rhNGF 180 µg/ml|"rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes.~rhNGF 180 µg/ml eye drops solution: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187983|NCT02110225|FG002|Participant Flow|Vehicle|"Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes.~Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187984|NCT02110225|OG000|Outcome|rhNGF 60µg/ml|"rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes~rhNGF 60 µg/ml eye drops solution: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187985|NCT02110225|OG001|Outcome|rhNGF 180 µg/ml|"rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes.~rhNGF 180 µg/ml eye drops solution: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187986|NCT02110225|OG002|Outcome|Vehicle|"Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes.~Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187987|NCT02110225|OG000|Outcome|rhNGF 60µg/ml|rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes rhNGF 60 µg/ml eye drops solution: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes
11187988|NCT02110225|EG000|Reported Event|rhNGF 60µg/ml|"rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes~rhNGF 60 µg/ml eye drops solution: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187989|NCT02110225|EG001|Reported Event|rhNGF 180 µg/ml|"rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes.~rhNGF 180 µg/ml eye drops solution: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187990|NCT02110225|EG002|Reported Event|Vehicle|"Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes.~Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes"
11187991|NCT02110238|BG000|Baseline|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
11187992|NCT02110238|BG001|Baseline|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
11187993|NCT02110238|BG002|Baseline|Total|Total of all reporting groups
11187994|NCT02110238|FG000|Participant Flow|Euflexxa|"Euflexxa® (hyaluronic acid of bacterial origin)~Euflexxa: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
11187995|NCT02110238|FG001|Participant Flow|Supartz|"SUPARTZ® (hyaluronic acid of avian origin)~Supartz: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
11187996|NCT02110238|OG000|Outcome|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
11187997|NCT02110238|OG001|Outcome|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
11187998|NCT02110238|EG000|Reported Event|Euflexxa|Euflexxa® (hyaluronic acid of bacterial origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
11187999|NCT02110238|EG001|Reported Event|Supartz|SUPARTZ® (hyaluronic acid of avian origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
11188000|NCT02110264|BG000|Baseline|Vivitrol (XR-NTX)|Long-acting naltrexone condition (XR-NTX) which will include monthly injections of study drug.
11188001|NCT02110264|BG001|Baseline|XR-NTX+PN|Long-acting naltrexone (XR-NTX) and assigned to a patient navigator (PN).
11188002|NCT02110264|BG002|Baseline|ETAU|Drug-education/treatment-as-usual.
11188003|NCT02110264|BG003|Baseline|Total|Total of all reporting groups
11188004|NCT02110264|FG000|Participant Flow|Vivitrol (XR-NTX)|Long-acting naltrexone condition (XR-NTX) which will included monthly injections of study drug.
11188005|NCT02110264|FG001|Participant Flow|XR-NTX+PN|Long-acting naltrexone (XR-NTX) and assignment of a patient navigator (PN).
11188006|NCT02110264|FG002|Participant Flow|ETAU|Treatment as usual, along with will receive drug education.
11188007|NCT02110264|OG000|Outcome|Vivitrol (XR-NTX)|Long-acting naltrexone condition (XR-NTX) which included monthly injections of study drug.
11188008|NCT02110264|OG001|Outcome|XR-NTX+PN|Long-acting naltrexone (XR-NTX) and assignment of a patient navigator (PN).
11188009|NCT02110264|OG002|Outcome|ETAU|Treatment as usual, along with will receive drug education.
11188010|NCT02110264|EG000|Reported Event|Vivitrol (XR-NTX)|Long-acting naltrexone condition (XR-NTX) which included monthly injections of study drug.
11188011|NCT02110264|EG001|Reported Event|XR-NTX+PN|Long-acting naltrexone (XR-NTX) and assignment of a patient navigator (PN).
11188012|NCT02110264|EG002|Reported Event|ETAU|Treatment as usual, along with will receive drug education.
11188013|NCT02110381|BG000|Baseline|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
11188014|NCT02110381|BG001|Baseline|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
11188015|NCT02110381|BG002|Baseline|Total|Total of all reporting groups
11188016|NCT02110381|FG000|Participant Flow|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
11188017|NCT02110381|FG001|Participant Flow|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
11188018|NCT02110381|OG000|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
11239123|NCT02468674|OG000|Outcome|Population: II BYM338 700 mg|Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
10962121|NCT00864916|OG000|Outcome|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
10962122|NCT00864916|OG001|Outcome|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
11239124|NCT02468674|OG001|Outcome|Population: II Placebo|Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
11239125|NCT02468674|EG000|Reported Event|Population I BYM338 700 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239126|NCT02468674|EG001|Reported Event|Population I BYM338 700 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239127|NCT02468674|EG002|Reported Event|Population I BYM338 210 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239128|NCT02468674|EG003|Reported Event|Population I BYM338 210 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239129|NCT02468674|EG004|Reported Event|Population I BYM338 70 mg|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239130|NCT02468674|EG005|Reported Event|Population I BYM338 70 mg to Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239131|NCT02468674|EG006|Reported Event|Population I Placebo|Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
11239132|NCT02468674|EG007|Reported Event|Population: II BYM338 700 mg|Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
11239133|NCT02468674|EG008|Reported Event|Population: II Placebo|Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
11239134|NCT02468700|BG000|Baseline|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11239135|NCT02468700|BG001|Baseline|Placebo Vehicle|PV (placebo drug delivery vehicle)
11239136|NCT02468700|BG002|Baseline|Total|Total of all reporting groups
11239137|NCT02468700|FG000|Participant Flow|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11239138|NCT02468700|FG001|Participant Flow|Placebo Vehicle|PV (placebo drug delivery vehicle)
11239139|NCT02468700|OG000|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11239140|NCT02468700|OG001|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
11239141|NCT02468700|EG000|Reported Event|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11239142|NCT02468700|EG001|Reported Event|Placebo Vehicle|PV (placebo drug delivery vehicle)
11239143|NCT02468804|BG000|Baseline|Parkinson's Disease Subjects|"Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded~REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere.~SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects."
11239144|NCT02468804|BG001|Baseline|Control Subjects|"Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded~REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere.~SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects."
11239145|NCT02468804|BG002|Baseline|Total|Total of all reporting groups
10962123|NCT00864916|EG000|Reported Event|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
10962124|NCT00864916|EG001|Reported Event|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
11239146|NCT02468804|FG000|Participant Flow|Parkinson's Disease Subjects|"Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded~REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere.~SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects."
11239147|NCT02468804|FG001|Participant Flow|Control Subjects|"Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded.~REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere.~SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects."
11239148|NCT02468804|OG000|Outcome|Parkinson's Disease Subjects|"Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere.~SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects."
11239149|NCT02468804|OG001|Outcome|Control Subjects|"Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere.~SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects."
11239150|NCT02468804|EG000|Reported Event|Parkinson's Disease Subjects|"Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded~REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere.~SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects."
11239151|NCT02468804|EG001|Reported Event|Control Subjects|"Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded.~REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere.~SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects."
11239152|NCT02468830|BG000|Baseline|Mirabegron|"Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.~mirabegron (initial dosage 25 mg this dose wil be maintain or increase to a maximum of 50 mg based on persistent of symptomsand side effect profile): Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy."
11239153|NCT02468830|FG000|Participant Flow|Mirabegron|"Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.~mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy."
11239154|NCT02468830|OG000|Outcome|Mirabegron|"Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.~mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy."
11239155|NCT02468830|EG000|Reported Event|Mirabegron|"Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.~mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy."
11239156|NCT02468934|BG000|Baseline|Enrolled/Received Leads|This group includes subjects that were consented, met eligibility criteria, and received Leads.
11239157|NCT02468934|FG000|Participant Flow|Consented Subjects|These subjects signed an informed consent form and met all eligibility criteria.
11239158|NCT02468934|OG000|Outcome|Underwent Total Knee Arthroplasty (TKA)|These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
10962125|NCT00865020|BG000|Baseline|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
11239159|NCT02468934|OG000|Outcome|Enrolled/Received Leads|This group includes subjects that were consented, met eligibility criteria, and received Leads.
11239160|NCT02468934|OG000|Outcome|Underwent Total Knee Arthroplasty (TKA)|These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty procedures.
11239161|NCT02468934|EG000|Reported Event|Enrolled/Received Leads|This group includes subjects that were consented, met eligibility criteria, and received Leads.
11239162|NCT02469038|BG000|Baseline|AccuCath Catheter|"We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group.~AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure."
11239163|NCT02469038|BG001|Baseline|Control|"We will use ultrasound-guided conventional IV for patients in the control group.~Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure."
11239164|NCT02469038|BG002|Baseline|Total|Total of all reporting groups
11239165|NCT02469038|FG000|Participant Flow|AccuCath Catheter|"We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group.~AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure."
11239166|NCT02469038|FG001|Participant Flow|Control|"We will use ultrasound-guided conventional IV for patients in the control group.~Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure."
11239167|NCT02469038|OG000|Outcome|AccuCath Catheter|"We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group.~AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure."
11239168|NCT02469038|OG001|Outcome|Control|"We will use ultrasound-guided conventional IV for patients in the control group.~Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure."
11239169|NCT02469038|EG000|Reported Event|AccuCath Catheter|"We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group.~AccuCath catheter: Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure."
11239170|NCT02469038|EG001|Reported Event|Control|"We will use ultrasound-guided conventional IV for patients in the control group.~Control: Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure."
11239171|NCT02469064|BG000|Baseline|Respiratory Muscle Training|"Experimental group receives as additional treatment respiratory muscle training.~Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients.~Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management"
11239172|NCT02469064|BG001|Baseline|Conventional Physical Therapy|"Conventional Cardiopulmonary Physical Therapy~Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management"
11239173|NCT02469064|BG002|Baseline|Total|Total of all reporting groups
11239174|NCT02469064|FG000|Participant Flow|Conventional Physical Therapy|"Conventional Cardiopulmonary Physical Therapy~Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management"
11239175|NCT02469064|FG001|Participant Flow|Respiratory Muscle Training|"Experimental group receives as additional treatment respiratory muscle training.~Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of maximum inspiratory pressure (MIP). At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at intensive care unit (ICU) and have experience with critically ill patients.~Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management"
11239176|NCT02469064|OG000|Outcome|Respiratory Muscle Training|"Experimental group receives as additional treatment respiratory muscle training.~Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients.~Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management"
11239177|NCT02469064|OG001|Outcome|Conventional Physical Therapy|"Conventional Cardiopulmonary Physical Therapy~Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management"
11240868|NCT02482610|FG002|Participant Flow|Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes."
11188019|NCT02110381|OG001|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
11188020|NCT02110381|EG000|Reported Event|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
11188021|NCT02110381|EG001|Reported Event|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
11188022|NCT02110381|EG002|Reported Event|Screen Failures|These subjects reflect individuals who: 1) consented to be in the study, 2) participated in the initial run-in period to evaluate blood pressure, 3) ended up not meeting the blood pressure criteria required for randomization
11188023|NCT02110485|BG000|Baseline|Patient Activation Tool|"Patients and their caregivers will receive the patient activation tool in addition to standard consultation~Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision."
11188024|NCT02110485|BG001|Baseline|Standard Consultation|Patients and their caregivers will receive standard consultation alone
11188025|NCT02110485|BG002|Baseline|Total|Total of all reporting groups
11188026|NCT02110485|FG000|Participant Flow|Patient Activation Tool|"Patients and their caregivers will receive the patient activation tool in addition to standard consultation~Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision."
11188027|NCT02110485|FG001|Participant Flow|Standard Consultation|Patients and their caregivers will receive standard consultation alone
11188028|NCT02110485|OG000|Outcome|Patient Activation Tool|"Patients and their caregivers will receive the patient activation tool in addition to standard consultation~Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision."
11188029|NCT02110485|OG001|Outcome|Standard Consultation|Patients and their caregivers will receive standard consultation alone
11188030|NCT02110485|EG000|Reported Event|Patient Activation Tool|"Patients and their caregivers will receive the patient activation tool in addition to standard consultation~Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision."
11188031|NCT02110485|EG001|Reported Event|Standard Consultation|Patients and their caregivers will receive standard consultation alone
11188032|NCT02110693|BG000|Baseline|Interviewer and Tablet Administration of TAPS Tool|All participants self-administered TAPS Tool on a computer tablet and were administered the TAPS Tool by an interviewer
11188033|NCT02110693|FG000|Participant Flow|Interviewer Then Tablet Administration|Interviewer will administer the substance use screening instrument first then self-administration of the same instrument on a tablet computer
11188034|NCT02110693|FG001|Participant Flow|Tablet First Then Interviewer Administration|Self-administration on tablet computer of screening instrument first, then interviewer administration of the same instrument.
11188035|NCT02110693|OG000|Outcome|Interviewer Administration|Interviewer administration of a substance misuse screening instrument (TAPS Tool).
11188036|NCT02110693|OG001|Outcome|Tablet Administration|Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
11239178|NCT02469064|EG000|Reported Event|Respiratory Muscle Training|"Experimental group receives as additional treatment respiratory muscle training.~Respiratory muscle training: Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients.~Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management"
11239179|NCT02469064|EG001|Reported Event|Conventional Physical Therapy|"Conventional Cardiopulmonary Physical Therapy~Cardiopulmonary Physical Therapy: Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management"
11239180|NCT02469077|BG000|Baseline|Exercise Plus Placebo/Morphine/Naloxone|"Participants randomly assigned to the exercise condition will complete an 18 session aerobic exercise manipulation supervised by an American College of Sports Medicine certified personal trainer (3 exercise sessions per week for 6 weeks). Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~exercise: Each exercise session will consist of a 5 minute warm-up, 30 minutes of aerobic exercise, followed by a 5 minute cool-down period. Aerobic exercise will consist of treadmill walking/running, stepping, elliptical, or cycling exercise as preferred by the participant. Duration of exercise will be standardized at 30 minutes with a target exercise intensity between 70-85% Heart Rate Reserve (RPE = 15, hard). Because of the focus on de-conditioned individuals with Chronic Low Back Pain, the duration and intensity of exercise wil"
11239181|NCT02469077|BG001|Baseline|Placebo/Morphine/Naloxone|"Participants assigned to the control condition will not undergo any manipulation during this 6 week period, and will be asked to continue their current activity levels and not engage in any additional exercise activity during the study period. Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~Placebo: In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will receive: 1) 4 doses of saline placebo (20ml each), 2) an 8mg dose of naloxone (in 20ml saline vehicle), followed by saline, 4mg naloxone, and saline, or 3) morphine sulfate (0.03 mg/kg in 20ml saline vehicle initially, followed by 3 incremental doses of 0.02mg/kg each)~Morphine: In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will receive: 1) 4 dose"
11239182|NCT02469077|BG002|Baseline|Total|Total of all reporting groups
11239183|NCT02469077|FG000|Participant Flow|6 Week Aerobic Exercise Intervention|Participants randomly assigned to the exercise condition will complete an 18 session aerobic exercise manipulation supervised by an American College of Sports Medicine-certified personal trainer (3 exercise sessions per week for 6 weeks). Immediately before and after participating in this intervention arm, participants will undergo laboratory evoked thermal pain response testing with placebo-controlled morphine and naloxone administration to assess mechanisms of exercise-related changes.
11239184|NCT02469077|FG001|Participant Flow|Normal Exercise (Control)|Participants assigned to the control condition will not undergo any exercise manipulation during this 6 week period, and will be asked to continue their current activity levels and not engage in any additional exercise activity during the study period. Immediately before and after participating in this intervention arm, participants will undergo laboratory evoked thermal pain response testing with placebo-controlled morphine and naloxone administration to assess mechanisms of exercise-related changes.
11239185|NCT02469077|OG000|Outcome|6 Week Aerobic Exercise Intervention|"Participants randomly assigned to the exercise condition will complete an 18 session aerobic exercise manipulation supervised by an American College of Sports Medicine-certified personal trainer (3 exercise sessions per week for 6 weeks). Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~exercise: Each exercise session will consist of a 5 minute warm-up, 30 minutes of aerobic exercise, followed by a 5 minute cool-down period. Aerobic exercise will consist of treadmill walking/running, stepping, elliptical, or cycling exercise as preferred by the participant. Duration of exercise will be standardized at 30 minutes with a target exercise intensity between 70-85% Heart Rate Reserve (RPE = 15, hard). Because of the focus on de-conditioned individuals with Chronic Low Back Pain, the duration and intensity of exercise wil"
11239186|NCT02469077|OG001|Outcome|Normal Exercise (Control)|"Participants assigned to the control condition will not undergo any manipulation during this 6 week period, and will be asked to continue their current activity levels and not engage in any additional exercise activity during the study period. Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~Placebo: In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will receive: 1) 4 doses of saline placebo (20ml each), 2) an 8mg dose of naloxone (in 20ml saline vehicle), followed by saline, 4mg naloxone, and saline, or 3) morphine sulfate (0.03 mg/kg in 20ml saline vehicle initially, followed by 3 incremental doses of 0.02mg/kg each)~Morphine: In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will receive: 1) 4 dose"
11240869|NCT02482610|FG003|Participant Flow|Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes."
11341807|NCT03688620|EG001|Reported Event|Vaccinated_Influsplit Tetra Group|Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
11239187|NCT02469077|OG000|Outcome|6 Week Aerobic Exercise Intervention|"Participants randomly assigned to the exercise condition will complete an 18 session aerobic exercise manipulation supervised by an American College of Sports Medicine-certified personal trainer (3 exercise sessions per week for 6 weeks).Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~exercise: Each exercise session will consist of a 5 minute warm-up, 30 minutes of aerobic exercise, followed by a 5 minute cool-down period. Aerobic exercise will consist of treadmill walking/running, stepping, elliptical, or cycling exercise as preferred by the participant. Duration of exercise will be standardized at 30 minutes with a target exercise intensity between 70-85% Heart Rate Reserve (RPE = 15, hard). Because of the focus on de-conditioned individuals with Chronic Low Back Pain, the duration and intensity of exercise will"
11239188|NCT02469077|OG001|Outcome|Normal Exercise (Control)|"Participants assigned to the control condition will not undergo any manipulation during this 6 week period, and will be asked to continue their current activity levels and not engage in any additional exercise activity during the study period. Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~Placebo: In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will receive: 1) 4 doses of saline placebo (20ml each), 2) an 8mg dose of naloxone (in 20ml saline vehicle), followed by saline, 4mg naloxone, and saline, or 3) morphine sulfate (0.03 mg/kg in 20ml saline vehicle initially, followed by 3 incremental doses of 0.02mg/kg each)~Morphine: In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will receive: 1) 4 doses"
11239189|NCT02469077|OG000|Outcome|6 Week Aerobic Exercise Intervention|"Participants randomly assigned to the exercise condition will complete an 18 session aerobic exercise manipulation supervised by American College of Sports Medicine-certified personal trainer (3 exercise sessions per week for 6 weeks). Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise related changes.~exercise: Each exercise session will consist of a 5 minute warm-up, 30 minutes of aerobic exercise, followed by a 5 minute cool-down period. Aerobic exercise will consist of treadmill walking/running, stepping, elliptical, or cycling exercise as preferred by the participant. Duration of exercise will be standardized at 30 minutes with a target exercise intensity between 70-85% Heart Rate Reserve (RPE = 15, hard). Because of the focus on de-conditioned individuals with Chronic Low Back Pain, the duration and intensity of exercise wil"
11239190|NCT02469077|OG000|Outcome|6 Week Aerobic Exercise Intervention|"Participants randomly assigned to the exercise condition will complete an 18 session aerobic exercise manipulation supervised by an American College of Sports Medicine certified personal trainer (3 exercise sessions per week for 6 weeks). Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~exercise: Each exercise session will consist of a 5 minute warm-up, 30 minutes of aerobic exercise, followed by a 5 minute cool-down period. Aerobic exercise will consist of treadmill walking/running, stepping, elliptical, or cycling exercise as preferred by the participant. Duration of exercise will be standardized at 30 minutes with a target exercise intensity between 70-85% Heart Rate Reserve (RPE = 15, hard). Because of the focus on de-conditioned individuals with Chronic Low Back Pain, the duration and intensity of exercise wil"
11239191|NCT02469077|EG000|Reported Event|Exercise Plus Placebo/Morphine/Naloxone|"Participants randomly assigned to the exercise condition will complete an 18 session aerobic exercise manipulation supervised by an American College of Sports Medicine certified personal trainer (3 exercise sessions per week for 6 weeks). Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~exercise: Each exercise session will consist of a 5 minute warm-up, 30 minutes of aerobic exercise, followed by a 5 minute cool-down period. Aerobic exercise will consist of treadmill walking/running, stepping, elliptical, or cycling exercise as preferred by the participant. Duration of exercise will be standardized at 30 minutes with a target exercise intensity between 70-85% Heart Rate Reserve (RPE = 15, hard). Because of the focus on de-conditioned individuals with Chronic Low Back Pain, the duration and intensity of exercise wil"
11239192|NCT02469077|EG001|Reported Event|Placebo/Morphine/Naloxone|"Participants assigned to the control condition will not undergo any manipulation during this 6 week period, and will be asked to continue their current activity levels and not engage in any additional exercise activity during the study period. Immediately before and after participating in this intervention arm, participants will undergo the placebo-controlled morphine and naloxone administration intervention to assess mechanisms of exercise-related changes.~Placebo: In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will receive: 1) 4 doses of saline placebo (20ml each), 2) an 8mg dose of naloxone (in 20ml saline vehicle), followed by saline, 4mg naloxone, and saline, or 3) morphine sulfate (0.03 mg/kg in 20ml saline vehicle initially, followed by 3 incremental doses of 0.02mg/kg each)~Morphine: In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will receive: 1) 4 dose"
11239193|NCT02469090|BG000|Baseline|Placebo (Maintenance)|Patients who completed the Dose Titration Phase and were randomized in a blinded manner (1:1 ratio) to receive placebo in the 12-week double-blind Maintenance Treatment Phase. Patients self-administered the matching placebo for the strength of treatment determined during the Dose Titration Phase in up to 5 'OFF' episodes per day for 12 weeks in the at-home portion of the study. Patients returned to the clinic in 4-week intervals for safety and efficacy assessments. Patients completed a dosing diary at home for 2 days prior to the scheduled visit.
11239194|NCT02469090|BG001|Baseline|APL-130277 (Mainenance)|Patients who completed the Dose Titration Phase and were randomized in a blinded manner (1:1 ratio) to receive APL-130277 in the 12-week double-blind Maintenance Treatment Phase. Patients self-administered the strength of treatment determined during the Dose Titration Phase in up to 5 'OFF' episodes per day for 12 weeks in the at-home portion of the study. Patients returned to the clinic in 4-week intervals for safety and efficacy assessments. Patients completed a dosing diary at home for 2 days prior to the scheduled visit.
11239195|NCT02469090|BG002|Baseline|Total|Total of all reporting groups
10962126|NCT00865020|BG001|Baseline|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
11239196|NCT02469090|FG000|Participant Flow|APL-130277 (Titration)|"Patients were titrated to identify the efficacious and tolerable dose of APL-130277.~On Titration Visit 1 (TV1), patients presented to the clinic in an 'OFF' state and received 10 mg APL-130277. Patients who responded to 10 mg APL-130277 with a full 'ON' response within 45 minutes of dosing, as assessed by the patient and Investigator, completed the Dose Titration Phase.~If a complete 'ON' response was not achieved within 45 minutes of dosing, patients restarted their normal PD medication and returned to the clinic within 3 days for the next TV, to receive the next sequential dose of APL-130277 (15 mg at TV2, 20 mg at TV3, 25 mg at TV4, 30 mg at TV5 and 35 mg at TV6). Patients who achieved a full 'ON' response within 45 minutes at a given dose were randomized to the Maintenance Treatment Phase. Any patients who reached 35 mg at TV6 and did not exhibit a full 'ON' response were discontinued."
11239197|NCT02469090|FG001|Participant Flow|Placebo (Maintnance)|Patients who completed the Dose Titration Phase and were randomized in a blinded manner (1:1 ratio) to receive placebo in the 12-week double-blind Maintenance Treatment Phase. Patients self-administered the matching placebo for the strength of treatment determined during the Dose Titration Phase in up to 5 'OFF' episodes per day for 12 weeks in the at-home portion of the study. Patients returned to the clinic in 4-week intervals for safety and efficacy assessments. Patients completed a dosing diary at home for 2 days prior to the scheduled visit.
11239198|NCT02469090|FG002|Participant Flow|APL-130277 (Maintenance)|Patients who completed the Dose Titration Phase and were randomized in a blinded manner (1:1 ratio) to receive APL-130277 in the 12-week double-blind Maintenance Treatment Phase. Patients self-administered the strength of treatment determined during the Dose Titration Phase in up to 5 'OFF' episodes per day for 12 weeks in the at-home portion of the study. Patients returned to the clinic in 4-week intervals for safety and efficacy assessments. Patients completed a dosing diary at home for 2 days prior to the scheduled visit.
11239199|NCT02469090|OG000|Outcome|Placebo (Maintenance)|Patients who completed the Dose Titration Phase and were randomized in a blinded manner (1:1 ratio) to receive placebo in the 12-week double-blind Maintenance Treatment Phase. Patients self-administered the matching placebo for the strength of treatment determined during the Dose Titration Phase in up to 5 'OFF' episodes per day for 12 weeks in the at-home portion of the study. Patients returned to the clinic in 4-week intervals for safety and efficacy assessments. Patients completed a dosing diary at home for 2 days prior to the scheduled visit.
11239200|NCT02469090|OG001|Outcome|APL-130277 (Maintenance)|Patients who completed the Dose Titration Phase and were randomized in a blinded manner (1:1 ratio) to receive APL-130277 in the 12-week double-blind Maintenance Treatment Phase. Patients self-administered the strength of treatment determined during the Dose Titration Phase in up to 5 'OFF' episodes per day for 12 weeks in the at-home portion of the study. Patients returned to the clinic in 4-week intervals for safety and efficacy assessments. Patients completed a dosing diary at home for 2 days prior to the scheduled visit.
11239201|NCT02469090|EG000|Reported Event|APL-130277 (Titration)|"Patients were titrated to identify the efficacious and tolerable dose of APL-130277.~On Titration Visit 1 (TV1), patients presented to the clinic in an 'OFF' state and received 10 mg APL-130277. Patients who responded to 10 mg APL-130277 with a full 'ON' response within 45 minutes of dosing, as assessed by the patient and Investigator, completed the Dose Titration Phase.~If a complete 'ON' response was not achieved within 45 minutes of dosing, patients restarted their normal PD medication and returned to the clinic within 3 days for the next TV, to receive the next sequential dose of APL-130277 (15 mg at TV2, 20 mg at TV3, 25 mg at TV4, 30 mg at TV5 and 35 mg at TV6). Patients who achieved a full 'ON' response within 45 minutes at a given dose were randomized to the Maintenance Treatment Phase. Any patients who reached 35 mg at TV6 and did not exhibit a full 'ON' response were discontinued."
11239202|NCT02469090|EG001|Reported Event|Placebo (Maintenance)|Patients who completed the Dose Titration Phase and were randomized in a blinded manner (1:1 ratio) to receive placebo in the 12-week double-blind Maintenance Treatment Phase. Patients self-administered the matching placebo for the strength of treatment determined during the Dose Titration Phase in up to 5 'OFF' episodes per day for 12 weeks in the at-home portion of the study. Patients returned to the clinic in 4-week intervals for safety and efficacy assessments. Patients completed a dosing diary at home for 2 days prior to the scheduled visit.
11239203|NCT02469090|EG002|Reported Event|APL-130277 (Maintenance)|Patients who completed the Dose Titration Phase and were randomized in a blinded manner (1:1 ratio) to receive APL-130277 in the 12-week double-blind Maintenance Treatment Phase. Patients self-administered the strength of treatment determined during the Dose Titration Phase in up to 5 'OFF' episodes per day for 12 weeks in the at-home portion of the study. Patients returned to the clinic in 4-week intervals for safety and efficacy assessments. Patients completed a dosing diary at home for 2 days prior to the scheduled visit.
11239204|NCT02469116|BG000|Baseline|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
11239205|NCT02469116|FG000|Participant Flow|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
11239206|NCT02469116|OG000|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
11239207|NCT02469116|EG000|Reported Event|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
11239208|NCT02469168|BG000|Baseline|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
11188037|NCT02110693|OG000|Outcome|Interviewer Administration|Interviewer administration of a substance misuse screening instrument (TAPS Tool)
11188038|NCT02110693|OG001|Outcome|Tablet Administration|Tablet computer administration of a substance misuse screening instrument (TAPS Tool).
11188039|NCT02110693|OG001|Outcome|Tablet Administration|Tablet computer of a substance misuse screening instrument (TAPS Tool).
11188040|NCT02110693|OG000|Outcome|Interviewer Administered|Interviewer administration of TAPS Tool. The ASSIST was interviewer administered as well.
11188041|NCT02110693|OG001|Outcome|Tablet Administration|Tablet computer administration of TAPS Tool. The ASSIST was administered in by an interview.
11188042|NCT02110693|OG000|Outcome|Interviewer Administered|Interviewer administered TAPS. The Time Line Follow Back was interviewer administered.
11188043|NCT02110693|OG001|Outcome|Tablet Administration|Tablet computer administration of TAPS Tool. The TLFB was interviewer administered.
11188044|NCT02110693|OG000|Outcome|Self-administered|Self-administered TAPS Tool. The AUDIT-C was interviewer administered.
11188045|NCT02110693|OG001|Outcome|Interviewer Administered|Interviewer administered TAPS Tool. The AUDIT-C was interviewer administered for both group
11188046|NCT02110693|OG000|Outcome|Self-administered TAPS Tool|Self-administered TAPS Tool. The Fagerstrom Test for Nicotine Dependence was administered by interviewer.
11188047|NCT02110693|OG001|Outcome|Interviewer Administered|Interviewer administered TAPS Tool. The Fagerstrom Test was interviewer administered.
11188048|NCT02110693|OG000|Outcome|Interviewer Administered|Interviewer administered TAPS Tool. The Smokeless Tobacco Questionnaire was interviewer administered.
11188049|NCT02110693|OG001|Outcome|Self Administered|Self-administered TAPS Tool. The Smokeless Tobacco Questionnaire was interviewer administered.
11188050|NCT02110693|OG000|Outcome|Interviewer Administered|Interviewer administered TAPS Tool. Oral Fluid Cannabis Test administered to the subset of participants that consented to provide an oral fluid sample. Oral fluid specimen was collected the same way in both arms.
11188051|NCT02110693|OG001|Outcome|Self-administered TAPS Tool|Self administered TAPS Tool. Oral Fluid Cannabis Test administered to the subset of participants that consented to provide an oral fluid sample. Oral fluid specimen was collected the same way in both arms.
11188052|NCT02110693|EG000|Reported Event|All Participants|All participants enrolled in the study (because all participants were administered both the self-administered and the interviewer administered versions of the instrument, we are reporting adverse events for the total sample)
11188053|NCT02110706|BG000|Baseline|Rituximab|- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188054|NCT02110706|BG001|Baseline|Placebo|- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188055|NCT02110706|BG002|Baseline|Total|Total of all reporting groups
11188056|NCT02110706|FG000|Participant Flow|Rituximab|- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188057|NCT02110706|FG001|Participant Flow|Placebo Group|- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188058|NCT02110706|OG000|Outcome|Rituximab|- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188059|NCT02110706|OG001|Outcome|Placebo|- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188060|NCT02110706|OG000|Outcome|Rituximab|- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months.Each cycle defined as one infusion per week for four consecutive weeks.For the main study, participants were followed for 52 weeks.Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188061|NCT02110706|OG001|Outcome|Placebo|"- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles~, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter."
11188062|NCT02110706|EG000|Reported Event|Rituximab|- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188063|NCT02110706|EG001|Reported Event|Placebo Group|- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
11188064|NCT02110732|BG000|Baseline|Lactobacillus Rhamnosus GG|"Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks~Lactobacillus rhamnosus GG"
11188065|NCT02110732|BG001|Baseline|Crystalline Cellulose|"Crystalline cellulose~Lactobacillus rhamnosus GG"
11188066|NCT02110732|BG002|Baseline|Total|Total of all reporting groups
11188067|NCT02110732|FG000|Participant Flow|Lactobacillus Rhamnosus GG|"Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks~Lactobacillus rhamnosus GG"
11188068|NCT02110732|FG001|Participant Flow|Crystalline Cellulose|"Crystalline cellulose~Lactobacillus rhamnosus GG"
11188069|NCT02110732|OG000|Outcome|Lactobacillus Rhamnosus GG|"Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks~Lactobacillus rhamnosus GG"
11188070|NCT02110732|OG001|Outcome|Crystalline Cellulose|"Crystalline cellulose~Lactobacillus rhamnosus GG"
11188071|NCT02110732|EG000|Reported Event|Lactobacillus Rhamnosus GG|"Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks~Lactobacillus rhamnosus GG"
11188072|NCT02110732|EG001|Reported Event|Crystalline Cellulose|"Crystalline cellulose~Lactobacillus rhamnosus GG"
11188073|NCT02110758|BG000|Baseline|Pilot Practices Patient Survey Cohort|"Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188074|NCT02110758|BG001|Baseline|Comparison Practices Patient Survey Cohort|"Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania~Intervention:~No intervention/Usual care"
11188075|NCT02110758|BG002|Baseline|Pilot Practices Utilization Cohort|"Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188076|NCT02110758|BG003|Baseline|Comparison Practices Utilization Cohort|"Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania~Intervention: No intervention/Usual care"
11188077|NCT02110758|BG004|Baseline|Pilot Practices Quality Measures Cohort|"Patients with a new diagnosis of cancer in the past two years~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188078|NCT02110758|BG005|Baseline|Total|Total of all reporting groups
11188079|NCT02110758|FG000|Participant Flow|Pilot Practices Patient Survey Cohort|"Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188080|NCT02110758|FG001|Participant Flow|Comparison Practices Patient Survey Cohort|"Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania~Intervention:~No intervention/Usual care"
11188081|NCT02110758|FG002|Participant Flow|Pilot Practices Utilization Cohort|"Patients with an evaluation & management claim attributed to a medical oncology pilot practice in southeastern Pennsylvania~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188082|NCT02110758|FG003|Participant Flow|Comparison Practices Utilization Cohort|"Patients with an evaluation & management claim attributed to a medical oncology comparison practice in southeastern Pennsylvania~Intervention: No intervention/Usual care"
11188083|NCT02110758|FG004|Participant Flow|Pilot Practices Quality Measures Cohort|"Patients with a new diagnosis of cancer in the past two years~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188084|NCT02110758|OG000|Outcome|Pilot Practices Patient Survey Cohort|"Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188085|NCT02110758|OG001|Outcome|Comparison Practices Patient Survey Cohort|"Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania~Intervention:~No intervention/Usual care"
11188086|NCT02110758|OG000|Outcome|Pilot Practices Quality Measures Cohort|"Patients with a new diagnosis of cancer in the past two years~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188087|NCT02110758|OG000|Outcome|Pilot Practices Utilization Cohort|"Patients with an evaluation & management claim attributed to a medical oncology pilot practice in southeastern Pennsylvania~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188088|NCT02110758|OG001|Outcome|Comparison Practices Utilization Cohort|Patients with an evaluation & management claim attributed to a medical oncology comparison practice in southeastern Pennsylvania
11188089|NCT02110758|EG000|Reported Event|Pilot Practices Patient Survey Cohort|"Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188090|NCT02110758|EG001|Reported Event|Comparison Practices Patient Survey Cohort|"Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania~Intervention:~No intervention/Usual care"
11188091|NCT02110758|EG002|Reported Event|Pilot Practices Utilization Cohort|"Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188092|NCT02110758|EG003|Reported Event|Comparison Practices Utilization Cohort|"Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania~Intervention: No intervention/Usual care"
11188093|NCT02110758|EG004|Reported Event|Pilot Practices Quality Measures Cohort|"Patients with a new diagnosis of cancer in the past two years~Intervention:~Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance."
11188094|NCT02110901|BG000|Baseline|Vonapanitase|Single application administered over 10 minutes at the time of fistula creation.
11188095|NCT02110901|BG001|Baseline|Placebo|Single application administered over 10 minutes at the time of fistula creation.
11188096|NCT02110901|BG002|Baseline|Total|Total of all reporting groups
11188097|NCT02110901|FG000|Participant Flow|Vonapanitase|Vonapanitase administered at the time of radiocephalic fistula creation
11188098|NCT02110901|FG001|Participant Flow|Placebo|Placebo administered at the time of radiocephalic fistula creation
11188099|NCT02110901|OG000|Outcome|Vonapanitase|Vonapanitase administered at the time of radiocephalic fistula creation
11188100|NCT02110901|OG001|Outcome|Placebo|Placebo administered at the time of radiocephalic fistula creation
11188101|NCT02110901|OG001|Outcome|Placebo|Placebo administered at the time of radiocephalic fistula creation.
11188102|NCT02110901|EG000|Reported Event|Vonapanitase|"Vonapanitase administered at the time of radiocephalic fistula creation~Vonapanitase"
11188103|NCT02110901|EG001|Reported Event|Placebo|"Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.~Placebo"
11188104|NCT02111083|BG000|Baseline|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100(reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
11188105|NCT02111083|BG001|Baseline|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100 (reference [R] on 2 occasions). Subjects were randomly assigned to dosing sequences RTRT.
11188106|NCT02111083|BG002|Baseline|Total|Total of all reporting groups
11188107|NCT02111083|FG000|Participant Flow|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
11188108|NCT02111083|FG001|Participant Flow|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences RTRT.
11188109|NCT02111083|OG000|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
11188110|NCT02111083|OG001|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
11188111|NCT02111083|EG000|Reported Event|Insulin Lispro A|Insulin Lispro A U-200 subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
11188112|NCT02111083|EG001|Reported Event|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
11188113|NCT02111096|BG000|Baseline|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188114|NCT02111096|BG001|Baseline|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188115|NCT02111096|BG002|Baseline|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
10962127|NCT00865020|BG002|Baseline|Total|Total of all reporting groups
11188116|NCT02111096|BG003|Baseline|Total|Total of all reporting groups
11188117|NCT02111096|FG000|Participant Flow|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188118|NCT02111096|FG001|Participant Flow|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188119|NCT02111096|FG002|Participant Flow|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188120|NCT02111096|OG000|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188121|NCT02111096|OG001|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188122|NCT02111096|OG002|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188123|NCT02111096|OG000|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188124|NCT02111096|OG001|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188125|NCT02111096|OG002|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188126|NCT02111096|EG000|Reported Event|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188127|NCT02111096|EG001|Reported Event|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188128|NCT02111096|EG002|Reported Event|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
11188129|NCT02111174|BG000|Baseline|Scrambler Therapy|"The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.~Scrambler Therapy"
11188130|NCT02111174|BG001|Baseline|Sham Therapy|"The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.~Sham Therapy"
11188131|NCT02111174|BG002|Baseline|Total|Total of all reporting groups
11188132|NCT02111174|FG000|Participant Flow|Scrambler Therapy|"The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.~Scrambler Therapy"
11188133|NCT02111174|FG001|Participant Flow|Sham Therapy|"The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.~Sham Therapy"
11188134|NCT02111174|OG000|Outcome|Scrambler Therapy|"The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.~Scrambler Therapy"
11188135|NCT02111174|OG001|Outcome|Sham Therapy|"The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.~Sham Therapy"
11188136|NCT02111174|EG000|Reported Event|Scrambler Therapy|"The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.~Scrambler Therapy"
11188137|NCT02111174|EG001|Reported Event|Sham Therapy|"The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.~Sham Therapy"
11188138|NCT02111187|BG000|Baseline|LDE225 (Arm1)|"Treatment arm (Arm 1) will receive LDE225 by mouth 800 mg daily for 4 weeks (+/- 3 days)~LDE225"
11188139|NCT02111187|BG001|Baseline|Observation Arm (Arm2)|Observation Arm (Arm2) will receive no treatment prior to prostatectomy.
11188140|NCT02111187|BG002|Baseline|Total|Total of all reporting groups
11188141|NCT02111187|FG000|Participant Flow|LDE225 (Arm1)|"Treatment arm (Arm 1) will receive LDE225 by mouth 800 mg daily for 4 weeks (+/- 3 days)~LDE225"
11188142|NCT02111187|FG001|Participant Flow|Observation Arm (Arm2)|Observation Arm (Arm2) will receive no treatment prior to prostatectomy.
11188143|NCT02111187|OG000|Outcome|LDE225 (Arm1)|"Treatment arm (Arm 1) will receive LDE225 by mouth 800 mg daily for 4 weeks (+/- 3 days)~LDE225"
11188144|NCT02111187|OG001|Outcome|Observation Arm (Arm2)|Observation Arm (Arm2) will receive no treatment prior to prostatectomy.
11188145|NCT02111187|EG000|Reported Event|LDE225 (Arm1)|"Treatment arm (Arm 1) will receive LDE225 by mouth 800 mg daily for 4 weeks (+/- 3 days)~LDE225"
11188146|NCT02111187|EG001|Reported Event|Observation Arm (Arm2)|Observation Arm (Arm2) will receive no treatment prior to prostatectomy.
11239209|NCT02469168|BG001|Baseline|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
11239210|NCT02469168|BG002|Baseline|Total|Total of all reporting groups
11341808|NCT03688620|EG002|Reported Event|Vaccinated_Fluarix Tetra Group|Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
11239211|NCT02469168|FG000|Participant Flow|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
11188147|NCT02111200|BG000|Baseline|Sodium Phenylbutyrate->MIX->Sodium Benzoate|"Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188148|NCT02111200|BG001|Baseline|Sodium Benzoate->MIX-> Sodium Phenylbutyrate|"Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188149|NCT02111200|BG002|Baseline|MIX->Sodium Benzoate-> Sodium Phenylbutyrate|"MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188150|NCT02111200|BG003|Baseline|MIX-> Sodium Phenylbutyrate-> Sodium Benzoate|"MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188151|NCT02111200|BG004|Baseline|Total|Total of all reporting groups
11188152|NCT02111200|FG000|Participant Flow|Sodium Phenylbutyrate->MIX->Sodium Benzoate (4 Days)|"Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188153|NCT02111200|FG001|Participant Flow|Sodium Benzoate->MIX-> Sodium Phenylbutyrate (4 Days)|"Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188154|NCT02111200|FG002|Participant Flow|MIX->Sodium Benzoate-> Sodium Phenylbutyrate (4 Days)|"MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188155|NCT02111200|FG003|Participant Flow|MIX-> Sodium Phenylbutyrate-> Sodium Benzoate (4 Days)|"MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188156|NCT02111200|OG000|Outcome|Sodium Benzoate Arm|"Sodium benzoate 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188157|NCT02111200|OG001|Outcome|Sodium Phenylbutyrate Arm|"Sodium phenylbutyrate 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188158|NCT02111200|OG002|Outcome|Mix Arm|"Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day will be given in three equal doses per day for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188159|NCT02111200|EG000|Reported Event|Sodium Benzoate Treatment|"Sodium benzoate 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188160|NCT02111200|EG001|Reported Event|Sodium Phenylbutyrate Treatment|"Sodium phenylbutyrate 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188161|NCT02111200|EG002|Reported Event|MIX Treatment|"Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day will be given in three equal doses per day for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
11188162|NCT02111213|BG000|Baseline|Promotora for Physical Activity|"Weekly sessions with a volunteer promotora at a community center. A promotora is a trained, lay health worker. The promotora will provide guidance, advice and support to participants to encourage them to be more physically active.~Promotora for physical activity: A promotora is a trained, lay health worker. Promotoras will be trained and supervised to provide advice, support and guidance to people to encourage them to be more physically active. They work with people face to face and by telephone to offer support and advice."
11188163|NCT02111213|BG001|Baseline|Carmen System|"Weekly sessions with the virtual advisor accessed through a computer located at a community center. Carmen is the virtual advisor and will provide guidance, advice and support to participants to encourage them to be more physically active.~Virtual Advisor: The virtual advisor is named Carmen. She is an animated, computer-generated figure that speaks to participants and gives advice and support for physical activity."
11188164|NCT02111213|BG002|Baseline|Total|Total of all reporting groups
11188165|NCT02111213|FG000|Participant Flow|Promotora for Physical Activity|"Weekly sessions with a volunteer promotora at a community center. A promotora is a trained, lay health worker. The promotora will provide guidance, advice and support to participants to encourage them to be more physically active.~Promotora for physical activity: A promotora is a trained, lay health worker. Promotoras will be trained and supervised to provide advice, support and guidance to people to encourage them to be more physically active. They work with people face to face and by telephone to offer support and advice."
11188166|NCT02111213|FG001|Participant Flow|Carmen System|"Weekly sessions with the virtual advisor accessed through a computer located at a community center. Carmen is the virtual advisor and will provide guidance, advice and support to participants to encourage them to be more physically active.~Virtual Advisor: The virtual advisor is named Carmen. She is an animated, computer-generated figure that speaks to participants and gives advice and support for physical activity."
11188167|NCT02111213|OG000|Outcome|Promotora for Physical Activity|"Weekly sessions with a volunteer promotora at a community center. A promotora is a trained, lay health worker. The promotora will provide guidance, advice and support to participants to encourage them to be more physically active.~Promotora for physical activity: A promotora is a trained, lay health worker. Promotoras will be trained and supervised to provide advice, support and guidance to people to encourage them to be more physically active. They work with people face to face and by telephone to offer support and advice."
11188168|NCT02111213|OG001|Outcome|Carmen System|"Weekly sessions with the virtual advisor accessed through a computer located at a community center. Carmen is the virtual advisor and will provide guidance, advice and support to participants to encourage them to be more physically active.~Virtual Advisor: The virtual advisor is named Carmen. She is an animated, computer-generated figure that speaks to participants and gives advice and support for physical activity."
11239212|NCT02469168|FG001|Participant Flow|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
11239213|NCT02469168|OG000|Outcome|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
11239214|NCT02469168|OG001|Outcome|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
11239215|NCT02469168|EG000|Reported Event|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
11239216|NCT02469168|EG001|Reported Event|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
11239217|NCT02469246|BG000|Baseline|F/TAF|F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
11239218|NCT02469246|BG001|Baseline|ABC/3TC|ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
11239219|NCT02469246|BG002|Baseline|Total|Total of all reporting groups
11239220|NCT02469246|FG000|Participant Flow|F/TAF|"Double-Blind Phase: Emtricitabine/tenofovir alafenamide (F/TAF) (200/10 mg) fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + abacavir/lamivudine (ABC/3TC) placebo tablet once daily for 96 weeks, and continued blinded treatment until unblinding. [Allowed boosted 3rd ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)].~Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country."
11239221|NCT02469246|FG001|Participant Flow|ABC/3TC|"Double-Blind Phase: ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks, and continued blinded treatment until unblinding. (Allowed boosted 3rd ARV agents: LPV/r, ATV + RTV, ATV + COBI or ATV/COBI FDC, DRV + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: EFV, RPV, RAL, DTG, MVC, or NVP)~Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country."
11239222|NCT02469246|OG000|Outcome|F/TAF|F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
11239223|NCT02469246|OG001|Outcome|ABC/3TC|ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
11239224|NCT02469246|EG000|Reported Event|F/TAF (Double-Blind Phase)|Adverse events reported occurred during the Double-Blind Phase in participants from the F/TAF group, who received F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily.
11239225|NCT02469246|EG001|Reported Event|ABC/3TC (Double-Blind Phase)|Adverse events reported occurred during the Double-Blind Phase in participants from the ABC/3TC group, who received ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent.
11239226|NCT02469246|EG002|Reported Event|Open-Label F/TAF From F/TAF|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the F/TAF group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.
11239227|NCT02469246|EG003|Reported Event|Open-Label F/TAF From ABC/3TC|Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the ABC/3TC group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.
11239228|NCT02469298|BG000|Baseline|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
11239229|NCT02469298|BG001|Baseline|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
11239230|NCT02469298|BG002|Baseline|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
11239231|NCT02469298|BG003|Baseline|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
11239232|NCT02469298|BG004|Baseline|Total|Total of all reporting groups
11239233|NCT02469298|FG000|Participant Flow|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
11239234|NCT02469298|FG001|Participant Flow|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
11239235|NCT02469298|FG002|Participant Flow|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
11239236|NCT02469298|FG003|Participant Flow|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
11239237|NCT02469298|OG000|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
11239238|NCT02469298|OG001|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
11188169|NCT02111213|EG000|Reported Event|Promotora for Physical Activity|"Weekly sessions with a volunteer promotora at a community center. A promotora is a trained, lay health worker. The promotora will provide guidance, advice and support to participants to encourage them to be more physically active.~Promotora for physical activity: A promotora is a trained, lay health worker. Promotoras will be trained and supervised to provide advice, support and guidance to people to encourage them to be more physically active. They work with people face to face and by telephone to offer support and advice."
11188170|NCT02111213|EG001|Reported Event|Carmen System|"Weekly sessions with the virtual advisor accessed through a computer located at a community center. Carmen is the virtual advisor and will provide guidance, advice and support to participants to encourage them to be more physically active.~Virtual Advisor: The virtual advisor is named Carmen. She is an animated, computer-generated figure that speaks to participants and gives advice and support for physical activity."
11188171|NCT02111252|BG000|Baseline|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
11188172|NCT02111252|FG000|Participant Flow|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
11188173|NCT02111252|OG000|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
11188174|NCT02111252|EG000|Reported Event|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
11188175|NCT02111369|BG000|Baseline|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
11188176|NCT02111369|FG000|Participant Flow|Propranolol/Botulinum|"After baseline analysis, patient will be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the patient had demonstrated no side effects. Dose may be increased to 240 mg each day depending on patient improvement and side effect profile. After second evaluation, patient will receive botulinum toxin injections. The risks and benefits of botulinum toxin therapy will be explained to the patient, and bilateral injections will take place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
11188177|NCT02111369|OG000|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
11188178|NCT02111369|EG000|Reported Event|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
11188179|NCT02111447|BG000|Baseline|Sevoflurane, Propofol, Nasal Oxygen|"After securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia.~Propofol: Propofol infusion with nasal oxygen~Propofol: Propofol infusion with an LMA"
11188180|NCT02111447|BG001|Baseline|Sevoflurane, Propofol, LMA|"After securing the IV, weight appropriate LMA will be inserted and sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. Oxygen in air will be delivered via LMA. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min after another 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be given if the child moves or exhibits signs of light anesthesia. The propofol infusion may also be increased in response to light anesthesia.~Propofol: Propofol infusion with nasal oxygen~Sevoflurane: Sevoflurane with an LMA"
11188181|NCT02111447|BG002|Baseline|Sevoflurane, Sevoflurane, LMA|"After securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed.~Sevoflurane: Sevoflurane with an LMA"
11239239|NCT02469298|OG002|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
11239240|NCT02469298|OG003|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
11239241|NCT02469298|OG000|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
11239242|NCT02469298|OG001|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
11239243|NCT02469298|OG002|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
11239244|NCT02469298|OG003|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
11239245|NCT02469298|OG000|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
11239246|NCT02469298|OG002|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
11239247|NCT02469298|OG000|Outcome|Danirixin (DNX) 75 mg|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
11239248|NCT02469298|EG000|Reported Event|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
11239249|NCT02469298|EG001|Reported Event|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
11239250|NCT02469298|EG002|Reported Event|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
11239251|NCT02469298|EG003|Reported Event|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
11239252|NCT02469389|BG000|Baseline|Engaging in Community Roles and Experiences (ENCoRE)|"Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training.~Engaging in Community Roles and Experiences (ENCoRE): Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training."
11239253|NCT02469389|BG001|Baseline|Health & Wellness (H&W)|"Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session).~Health & Wellness (H&W): Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application.~Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session)."
11239254|NCT02469389|BG002|Baseline|Total|Total of all reporting groups
11239255|NCT02469389|FG000|Participant Flow|Engaging in Community Roles and Experiences (ENCoRE)|"Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training.~Engaging in Community Roles and Experiences (ENCoRE): Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training."
11239256|NCT02469389|FG001|Participant Flow|Health & Wellness (H&W)|"Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session).~Health & Wellness (H&W): Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application.~Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session)."
11360638|NCT02534038|FG000|Participant Flow|AVP-786; Placebo|In Period 1, participants were randomized to receive AVP-786 (deuterated [d6]-dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) once a day (OD) in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 twice a day (BID) for 14 days. From Day 22, participants received a target dose of d6-DM 28 milligrams (mg)/Q 4.9 mg (AVP-786-28/4.9) BID for the remaining 3 weeks of Period 1. In Period 2, participants were randomized to receive matching placebo. The periods were separated by a 2-week washout period.
11360639|NCT02534038|FG001|Participant Flow|Placebo; AVP-786|In Period 1, participants were randomized to receive matching placebo. In Period 2, participants were randomized to receive AVP-786 OD in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 BID for 14 days. From Day 22, participants received a target dose of AVP-786-28/4.9 BID for the remaining 3 weeks of Period 2. The periods were separated by a 2-week washout period.
11360640|NCT02534038|OG000|Outcome|Placebo|Participants received matching placebo in either the first or last 6 weeks of the study.
11360641|NCT02534038|OG001|Outcome|AVP-786|Participants received up to a target dose of deuterated (d6)-dextromethorphan hydrobromide (d6-DM) 28 milligrams (mg)/quinidine sulfate (Q) 4.9 mg (AVP-786-28/4.9) twice a day (BID) in either the first or last 6 weeks of the study.
11360642|NCT02534038|OG001|Outcome|AVP-786|Participants received up to a target dose of AVP-786-28/4.9 BID in either the first or last 6 weeks of the study.
11360643|NCT02534038|EG000|Reported Event|Placebo|Participants received matching placebo for 6 weeks.
11360644|NCT02534038|EG001|Reported Event|AVP-786|Participants received AVP-786 (up to a target dose of d6-DM 28 milligrams [mg]/Q 4.9 mg [AVP-786-28/4.9] twice a day [BID]) for 6 weeks.
11360645|NCT02520726|BG000|Baseline|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
11360646|NCT02520726|BG001|Baseline|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
11360647|NCT02520726|BG002|Baseline|Total|Total of all reporting groups
11360648|NCT02520726|FG000|Participant Flow|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
11360649|NCT02520726|FG001|Participant Flow|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
11360650|NCT02520726|OG000|Outcome|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
11360651|NCT02520726|OG001|Outcome|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
11360652|NCT02520726|EG000|Reported Event|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
11360653|NCT02520726|EG001|Reported Event|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
11360654|NCT02520297|BG000|Baseline|TRV130|Drug: TRV130
11360655|NCT02520297|FG000|Participant Flow|TRV130|Drug: TRV130
11360656|NCT02520297|OG000|Outcome|TRV130|Drug: TRV130
11360657|NCT02520297|EG000|Reported Event|TRV130|Drug: TRV130
11360658|NCT02519712|BG000|Baseline|Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells|"This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.~Adverse Events information cannot be separated by donors and recipients due to data privacy reasons."
11360659|NCT02519712|FG000|Participant Flow|Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells|"This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.~Donors and participants are combined because the study was closed to poor accrual and there are no clinical results."
11360660|NCT02519712|OG000|Outcome|Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells|"This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.~Induction Chemotherapy: Patients with newly diagnosed AML will receive standard induction chemotherapy with daunorubicin and cytarabine (7+3 scheme). Patients who achieve CR may undergo consolidation chemotherapy at the discretion of the treating leukemia physician.~G-PBSC Infusion: G-CSF-mobilized peripheral blood cells will be collected from the donors in the Donor Room according to standard MSKCC BMT guidelines. Patients will be infused by infusion of unmanipulated G-PBSC from a haploidentical related donor."
11360661|NCT02519712|EG000|Reported Event|Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells|"This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.~Adverse Events information cannot be separated by donors and recipients due to data privacy reasons"
11360662|NCT02518750|BG000|Baseline|Study Participants|"Participants with ALL will receive the following interventions in three treatment blocks:~Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples~Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine~Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide"
11360663|NCT02518750|FG000|Participant Flow|Study Paticipants|"Participants with ALL will receive the following interventions in three treatment blocks:~Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples~Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine~Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide"
11360664|NCT02518750|OG000|Outcome|Study Paticipants|"Participants with ALL will receive the following interventions in three treatment blocks:~Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples~Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine.~Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide"
11360665|NCT02518750|EG000|Reported Event|Study Participants|"Participants with ALL will receive the following interventions in three treatment blocks:~Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples~Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine~Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide"
11360666|NCT02516228|BG000|Baseline|GTEN 100|"All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only.~GTEN 100: Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day.~During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days."
11360667|NCT02516228|FG000|Participant Flow|GTEN 100|"All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only.~GTEN 100: Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day.~During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days."
11360668|NCT02516228|OG000|Outcome|GTEN 100|"All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only.~GTEN 100: Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day.~During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days."
11360669|NCT02516228|EG000|Reported Event|GTEN 100|"All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only.~GTEN 100: Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day.~During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days."
11360670|NCT02515851|BG000|Baseline|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
11360671|NCT02515851|BG001|Baseline|Placebo Group|"Group that receives placebo injections~Placebo"
11360672|NCT02515851|BG002|Baseline|Total|Total of all reporting groups
11360673|NCT02515851|FG000|Participant Flow|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
11360674|NCT02515851|FG001|Participant Flow|Placebo Group|"Group that receives placebo injections~Placebo"
11360675|NCT02515851|OG000|Outcome|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
11188182|NCT02111447|BG003|Baseline|Sevoflurane, Isoflurane, LMA|"After securing the IV, weight appropriate LMA will be inserted , sevoflurane will be discontinued and isoflurane will be administered at 2 % inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. Isoflurane may be increased or decreased in 0.5% increments as needed.~Sevoflurane: Sevoflurane with an LMA~Isoflurane: Isoflurane with an LMA"
11188183|NCT02111447|BG004|Baseline|Total|Total of all reporting groups
11360676|NCT02515851|OG001|Outcome|Placebo Group|"Group that receives placebo injections~Placebo"
11360677|NCT02515851|EG000|Reported Event|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
11360678|NCT02515851|EG001|Reported Event|Placebo Group|"Group that receives placebo injections~Placebo"
11360679|NCT02506985|BG000|Baseline|Rivaroxaban|"For the first 3 weeks, patients will receive rivaroxaban 15mg twice-daily; thereafter they will take rivaroxaban 20mg once-daily as per the drug label. Rivaroxaban will be initiated immediately following completion of alterplase infusion, and heparin will be discontinued at the time of rivaroxaban administration.~rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily."
11360680|NCT02506985|BG001|Baseline|Heparin-warfarin|"Unfractioned heparin (UFH), following hospital protocol to achieve a target PTT or enoxaparin, 1.0mg/kg twice-daily, for a minimal duration of treatment of 5 days. Warfarin may be started on the night after CDT. UFH or enoxaparin should continue until the INR is >= 2.0 on two consecutive measurements at least 24 hours apart with an advised overlap with VKA for 4 to 5 days. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0).~warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3."
11360681|NCT02506985|BG002|Baseline|Total|Total of all reporting groups
11360682|NCT02506985|FG000|Participant Flow|Rivaroxaban|"For the first 3 weeks, patients will receive rivaroxaban 15mg twice-daily; thereafter they will take rivaroxaban 20mg once-daily as per the drug label. Rivaroxaban will be initiated immediately following completion of alterplase infusion, and heparin will be discontinued at the time of rivaroxaban administration.~rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily."
11360683|NCT02506985|FG001|Participant Flow|Heparin-warfarin|"Unfractioned heparin (UFH), following hospital protocol to achieve a target PTT or enoxaparin, 1.0mg/kg twice-daily, for a minimal duration of treatment of 5 days. Warfarin may be started on the night after CDT. UFH or enoxaparin should continue until the INR is >= 2.0 on two consecutive measurements at least 24 hours apart with an advised overlap with VKA for 4 to 5 days. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0).~warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3."
11360684|NCT02506985|OG000|Outcome|Rivaroxaban|"For the first 3 weeks, patients will receive rivaroxaban 15mg twice-daily; thereafter they will take rivaroxaban 20mg once-daily as per the drug label. Rivaroxaban will be initiated immediately following completion of alterplase infusion, and heparin will be discontinued at the time of rivaroxaban administration.~rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily."
11360685|NCT02506985|OG001|Outcome|Heparin-warfarin|"Unfractioned heparin (UFH), following hospital protocol to achieve a target PTT or enoxaparin, 1.0mg/kg twice-daily, for a minimal duration of treatment of 5 days. Warfarin may be started on the night after CDT. UFH or enoxaparin should continue until the INR is >= 2.0 on two consecutive measurements at least 24 hours apart with an advised overlap with VKA for 4 to 5 days. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0).~warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3."
11360686|NCT02506985|EG000|Reported Event|Rivaroxaban|"For the first 3 weeks, patients will receive rivaroxaban 15mg twice-daily; thereafter they will take rivaroxaban 20mg once-daily as per the drug label. Rivaroxaban will be initiated immediately following completion of alterplase infusion, and heparin will be discontinued at the time of rivaroxaban administration.~rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily."
11360687|NCT02506985|EG001|Reported Event|Heparin-warfarin|"Unfractioned heparin (UFH), following hospital protocol to achieve a target PTT or enoxaparin, 1.0mg/kg twice-daily, for a minimal duration of treatment of 5 days. Warfarin may be started on the night after CDT. UFH or enoxaparin should continue until the INR is >= 2.0 on two consecutive measurements at least 24 hours apart with an advised overlap with VKA for 4 to 5 days. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0).~warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3."
11360688|NCT02514252|BG000|Baseline|Fentanyl Sublingual Spray (FSS)|Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.
11360689|NCT02514252|FG000|Participant Flow|Fentanyl Sublingual Spray (FSS)|Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.
11360690|NCT02514252|OG000|Outcome|Fentanyl Sublingual Spray (FSS)|Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.
11360691|NCT02514252|EG000|Reported Event|Fentanyl Sublingual Spray (FSS)|Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.
11360692|NCT02501759|BG000|Baseline|Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)|"Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.~3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast~Gadodiamide: Given IV~Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast~Transrectal Biopsy: Undergo transrectal MRI-guided biopsy~Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy"
11341809|NCT03688685|BG000|Baseline|Open-label Study of CAD-1883|"Open-label study designed to evaluate the safety, tolerability, and efficacy of CAD-1883 administered twice daily orally to adult subjects with ET~CAD-1883: Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days."
11341810|NCT03688685|FG000|Participant Flow|Open-label Study of CAD-1883|"Open-label study designed to evaluate the safety, tolerability, and efficacy of CAD-1883 administered twice daily orally to adult subjects with ET~CAD-1883: Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days."
11341811|NCT03688685|OG000|Outcome|Open-label Study of CAD-1883|"Open-label study designed to evaluate the safety, tolerability, and efficacy of CAD-1883 administered twice daily orally to adult subjects with ET~CAD-1883: Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days."
11341812|NCT03688685|EG000|Reported Event|Open-label Study of CAD-1883|"Open-label study designed to evaluate the safety, tolerability, and efficacy of CAD-1883 administered twice daily orally to adult subjects with ET~CAD-1883: Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days."
11341813|NCT03688711|BG000|Baseline|Dasiglucagon 0.6 mg|"single fixed dose (subcutaneous injection) of dasiglucagon~Dasiglucagon: Glucagon analogue"
11341814|NCT03688711|BG001|Baseline|Placebo|"single fixed dose (subcutaneous injection) of placebo~Placebo: Placebo for dasiglucagon"
11341815|NCT03688711|BG002|Baseline|Total|Total of all reporting groups
11341816|NCT03688711|FG000|Participant Flow|Dasiglucagon 0.6 mg|"single fixed dose (subcutaneous injection) of dasiglucagon~Dasiglucagon: Glucagon analogue"
11341817|NCT03688711|FG001|Participant Flow|Placebo|"single fixed dose (subcutaneous injection) of placebo~Placebo: Placebo for dasiglucagon"
11341818|NCT03688711|OG000|Outcome|Dasiglucagon 0.6 mg|"single fixed dose (subcutaneous injection) of dasiglucagon~Dasiglucagon: Glucagon analogue"
11341819|NCT03688711|OG001|Outcome|Placebo|"single fixed dose (subcutaneous injection) of placebo~Placebo: Placebo for dasiglucagon"
11341820|NCT03688711|EG000|Reported Event|Dasiglucagon 0.6 mg|"single fixed dose (subcutaneous injection) of dasiglucagon~Dasiglucagon: Glucagon analogue"
11341821|NCT03688711|EG001|Reported Event|Placebo|"single fixed dose (subcutaneous injection) of placebo~Placebo: Placebo for dasiglucagon"
11341822|NCT03688880|BG000|Baseline|Dermabond Advanced|Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization.
11341823|NCT03688880|BG001|Baseline|MAR-CUTIS|MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization.
11341824|NCT03688880|BG002|Baseline|Total|Total of all reporting groups
11341825|NCT03688880|FG000|Participant Flow|Dermabond Advanced|Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization.
11341826|NCT03688880|FG001|Participant Flow|MAR-CUTIS|MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 millimeter (mm) thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization.
11341827|NCT03688880|OG000|Outcome|Dermabond Advanced|Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization.
11341828|NCT03688880|OG001|Outcome|MAR-CUTIS|MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization.
11341829|NCT03688880|EG000|Reported Event|Dermabond Advanced|Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization.
11341830|NCT03688880|EG001|Reported Event|MAR-CUTIS|MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization.
11341831|NCT03689452|BG000|Baseline|Platelet-rich Plasma Group|4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
11341832|NCT03689452|BG001|Baseline|Placebo Group|4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
11341833|NCT03689452|BG002|Baseline|Total|Total of all reporting groups
11341834|NCT03689452|FG000|Participant Flow|Platelet Rich Plasma (PRP) Group|4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
11341835|NCT03689452|FG001|Participant Flow|Placebo Group|4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
11341836|NCT03689452|OG000|Outcome|Platelet-rich Plasma Group|4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
11341837|NCT03689452|OG001|Outcome|Placebo Group|4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
11341838|NCT03689452|EG000|Reported Event|Platelet-rich Plasma Group|4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
11360693|NCT02501759|FG000|Participant Flow|Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)|"Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.~3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast~Gadodiamide: Given IV~Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast~Transrectal Biopsy: Undergo transrectal MRI-guided biopsy~Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy"
11360694|NCT02501759|OG000|Outcome|Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)|"Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.~3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast~Gadodiamide: Given IV~Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast~Transrectal Biopsy: Undergo transrectal MRI-guided biopsy~Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy"
11360695|NCT02501759|EG000|Reported Event|Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)|"Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.~3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast~Gadodiamide: Given IV~Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast~Transrectal Biopsy: Undergo transrectal MRI-guided biopsy~Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy"
11360696|NCT02487277|BG000|Baseline|Combination Therapy With 1 Week Run-In|"PEGPH20: 3ug/kg on Days 1 and 4~1 cycle = 28 days~PEGPH20: 3ug/kg on Days 1, 8, 15~Gemcitabine: 1000mg/m^2 on Days 1, 8, 15~Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15~PEGPH20~Gemcitabine~Nab-paclitaxel"
11360697|NCT02487277|BG001|Baseline|Combination Therapy Alone|"1 cycle = 28 days~PEGPH20: 3ug/kg on Days 1, 8, 15~Gemcitabine: 1000mg/m^2 on Days 1, 8, 15~Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15~PEGPH20~Gemcitabine~Nab-paclitaxel"
11360698|NCT02487277|BG002|Baseline|Total|Total of all reporting groups
11360699|NCT02487277|FG000|Participant Flow|Combination Therapy With 1 Week Run-In|"PEGPH20: 3ug/kg on Days 1 and 4~1 cycle = 28 days~PEGPH20: 3ug/kg on Days 1, 8, 15~Gemcitabine: 1000mg/m^2 on Days 1, 8, 15~Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15~PEGPH20~Gemcitabine~Nab-paclitaxel"
11360700|NCT02487277|FG001|Participant Flow|Combination Therapy Alone|"1 cycle = 28 days~PEGPH20: 3ug/kg on Days 1, 8, 15~Gemcitabine: 1000mg/m^2 on Days 1, 8, 15~Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15~PEGPH20~Gemcitabine~Nab-paclitaxel"
11360701|NCT02487277|OG000|Outcome|Combination Therapy With 1 Week Run-In|"PEGPH20: 3ug/kg on Days 1 and 4~1 cycle = 28 days~PEGPH20: 3ug/kg on Days 1, 8, 15~Gemcitabine: 1000mg/m^2 on Days 1, 8, 15~Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15~PEGPH20~Gemcitabine~Nab-paclitaxel"
11360702|NCT02487277|OG001|Outcome|Combination Therapy Alone|"1 cycle = 28 days~PEGPH20: 3ug/kg on Days 1, 8, 15~Gemcitabine: 1000mg/m^2 on Days 1, 8, 15~Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15~PEGPH20"
11360703|NCT02487277|EG000|Reported Event|Combination Therapy With 1 Week Run-In|"PEGPH20: 3ug/kg on Days 1 and 4~1 cycle = 28 days~PEGPH20: 3ug/kg on Days 1, 8, 15~Gemcitabine: 1000mg/m^2 on Days 1, 8, 15~Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15~PEGPH20~Gemcitabine~Nab-paclitaxel"
11360704|NCT02506101|BG000|Baseline|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
11360705|NCT02506101|BG001|Baseline|no Intervention|untreated
11360706|NCT02506101|BG002|Baseline|Total|Total of all reporting groups
11360707|NCT02506101|FG000|Participant Flow|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
11360708|NCT02506101|FG001|Participant Flow|no Intervention|untreated
11360709|NCT02506101|OG000|Outcome|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
11360710|NCT02506101|OG001|Outcome|no Intervention|untreated
11360711|NCT02506101|EG000|Reported Event|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
11360712|NCT02506101|EG001|Reported Event|no Intervention|untreated
11360713|NCT02499887|BG000|Baseline|Standard of Care|"Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)~Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.~albuterol: Inhaler~Prednisone: Oral corticosteroid"
11240870|NCT02482610|FG004|Participant Flow|Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes."
11240871|NCT02482610|FG005|Participant Flow|Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes."
11240872|NCT02482610|OG000|Outcome|Glucose|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes."
11240873|NCT02482610|OG001|Outcome|Glucose With Whole Fat Milk|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose with Whole Fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes."
11240874|NCT02482610|OG002|Outcome|Glucose With Non-fat Milk|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes."
11240875|NCT02482610|EG000|Reported Event|Glucose, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes."
11240876|NCT02482610|EG001|Reported Event|Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes."
11240877|NCT02482610|EG002|Reported Event|Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes."
11240878|NCT02482610|EG003|Reported Event|Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes."
11240879|NCT02482610|EG004|Reported Event|Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes."
11240880|NCT02482610|EG005|Reported Event|Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose|"Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women.~Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes."
11240881|NCT02482675|BG000|Baseline|All Study Participants|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11341839|NCT03689452|EG001|Reported Event|Placebo Group|4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection.
11239257|NCT02469389|OG000|Outcome|Engaging in Community Roles and Experiences (ENCoRE)|"Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training.~Engaging in Community Roles and Experiences (ENCoRE): Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training."
11239258|NCT02469389|OG001|Outcome|Health & Wellness (H&W)|"Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session).~Health & Wellness (H&W): Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application.~Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session)."
11239259|NCT02469389|EG000|Reported Event|Engaging in Community Roles and Experiences (ENCoRE)|"Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training.~Engaging in Community Roles and Experiences (ENCoRE): Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training."
11239260|NCT02469389|EG001|Reported Event|Health & Wellness (H&W)|"Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session).~Health & Wellness (H&W): Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application.~Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session)."
11239261|NCT02469597|BG000|Baseline|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
11239262|NCT02469597|BG001|Baseline|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
11239263|NCT02469597|BG002|Baseline|Total|Total of all reporting groups
11239264|NCT02469597|FG000|Participant Flow|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
11239265|NCT02469597|FG001|Participant Flow|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
11239266|NCT02469597|OG000|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
11239267|NCT02469597|OG001|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
11239268|NCT02469597|EG000|Reported Event|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
11239269|NCT02469597|EG001|Reported Event|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
11239270|NCT02469610|BG000|Baseline|Study|"In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.~Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces."
11239271|NCT02469610|BG001|Baseline|Control|"In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.~Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces."
11239272|NCT02469610|BG002|Baseline|Total|Total of all reporting groups
11360714|NCT02499887|BG001|Baseline|Treatment|"Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days~Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.~beclamethasone dipropionate: Inhaler~albuterol: Inhaler~Prednisone: Oral corticosteroid"
11188184|NCT02111447|FG000|Participant Flow|Sevoflurane, Propofol, Nasal Oxygen|"After securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia.~Propofol: Propofol infusion with nasal oxygen~Propofol: Propofol infusion with an LMA"
11188185|NCT02111447|FG001|Participant Flow|Sevoflurane, Propofol, LMA|"After securing the IV, weight appropriate LMA will be inserted and sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. Oxygen in air will be delivered via LMA. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min after another 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be given if the child moves or exhibits signs of light anesthesia. The propofol infusion may also be increased in response to light anesthesia.~Propofol: Propofol infusion with nasal oxygen~Sevoflurane: Sevoflurane with an LMA"
11188186|NCT02111447|FG002|Participant Flow|Sevoflurane, Sevoflurane, LMA|"After securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed.~Sevoflurane: Sevoflurane with an LMA"
11188187|NCT02111447|FG003|Participant Flow|Sevoflurane, Isoflurane, LMA|"After securing the IV, weight appropriate LMA will be inserted , sevoflurane will be discontinued and isoflurane will be administered at 2 % inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. Isoflurane may be increased or decreased in 0.5% increments as needed.~Sevoflurane: Sevoflurane with an LMA~Isoflurane: Isoflurane with an LMA"
11188188|NCT02111447|OG000|Outcome|Sevoflurane, Propofol, Nasal Oxygen|"After securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia.~Propofol: Propofol infusion with nasal oxygen~Propofol: Propofol infusion with an LMA"
11188189|NCT02111447|OG001|Outcome|Sevoflurane, Sevoflurane, LMA|"After securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed.~Sevoflurane: Sevoflurane with an LMA"
11188190|NCT02111447|OG002|Outcome|Sevoflurane, Propofol, LMA|"After securing the IV, weight appropriate LMA will be inserted and sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. Oxygen in air will be delivered via LMA. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min after another 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be given if the child moves or exhibits signs of light anesthesia. The propofol infusion may also be increased in response to light anesthesia.~Propofol: Propofol infusion with nasal oxygen~Sevoflurane: Sevoflurane with an LMA"
11188191|NCT02111447|OG003|Outcome|Sevoflurane, Isoflurane, LMA|"After securing the IV, weight appropriate LMA will be inserted , sevoflurane will be discontinued and isoflurane will be administered at 2 % inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. Isoflurane may be increased or decreased in 0.5% increments as needed.~Sevoflurane: Sevoflurane with an LMA~Isoflurane: Isoflurane with an LMA"
11188192|NCT02111447|EG000|Reported Event|Sevoflurane, Propofol, Nasal Oxygen|"After securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia.~Propofol: Propofol infusion with nasal oxygen~Propofol: Propofol infusion with an LMA"
11188193|NCT02111447|EG001|Reported Event|Sevoflurane, Sevoflurane, LMA|"After securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed.~Sevoflurane: Sevoflurane with an LMA"
11188194|NCT02111447|EG002|Reported Event|Sevoflurane, Propofol, LMA|"After securing the IV, weight appropriate LMA will be inserted and sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. Oxygen in air will be delivered via LMA. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min after another 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be given if the child moves or exhibits signs of light anesthesia. The propofol infusion may also be increased in response to light anesthesia.~Propofol: Propofol infusion with nasal oxygen~Sevoflurane: Sevoflurane with an LMA"
11188195|NCT02111447|EG003|Reported Event|Sevoflurane, Isoflurane, LMA|"After securing the IV, weight appropriate LMA will be inserted , sevoflurane will be discontinued and isoflurane will be administered at 2 % inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. Isoflurane may be increased or decreased in 0.5% increments as needed.~Sevoflurane: Sevoflurane with an LMA~Isoflurane: Isoflurane with an LMA"
11360715|NCT02499887|BG002|Baseline|Total|Total of all reporting groups
11188196|NCT02111564|BG000|Baseline|Rivaroxaban 10 mg or 7.5 mg|Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
11188197|NCT02111564|BG001|Baseline|Placebo|Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
11188198|NCT02111564|BG002|Baseline|Total|Total of all reporting groups
11188199|NCT02111564|FG000|Participant Flow|Rivaroxaban 10 mg or 7.5 mg|Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
11188200|NCT02111564|FG001|Participant Flow|Placebo|Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
11188201|NCT02111564|OG000|Outcome|Rivaroxaban 10 mg or 7.5 mg|Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
11188202|NCT02111564|OG001|Outcome|Placebo|Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
11188203|NCT02111564|EG000|Reported Event|Rivaroxaban 10 mg or 7.5 mg|Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
11188204|NCT02111564|EG001|Reported Event|Placebo|Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
11188205|NCT02111577|BG000|Baseline|DCVAC/PCa With Standard of Care Chemotherapy|Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
11188206|NCT02111577|BG001|Baseline|Placebo With Standard of Care Chemotherapy|Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
11188207|NCT02111577|BG002|Baseline|Total|Total of all reporting groups
11188208|NCT02111577|FG000|Participant Flow|DCVAC/PCa With Standard of Care Chemotherapy|Combination therapy with dendritic cell vaccine for prostate cancer (DCVAC/PCa) and standard of care chemotherapy (docetaxel and prednisone)
11188209|NCT02111577|FG001|Participant Flow|Placebo With Standard of Care Chemotherapy|Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
11188210|NCT02111577|OG000|Outcome|DCVAC/PCa With Standard of Care Chemotherapy|"Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)~DCVAC/PCa: DCVAC/PCa concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). DCVAC/PCa was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of DCVAC/PCa was given every 4 weeks (-7/+14 days) for up to a total of 15 doses."
11188211|NCT02111577|OG001|Outcome|Placebo With Standard of Care Chemotherapy|"Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator~Placebo: Placebo concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). Placebo was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of placebo was given every 4 weeks (-7/+14 days) for up to a total of 15 doses."
11188212|NCT02111577|OG000|Outcome|DCVAC/PCa With Standard of Care Chemotherapy|Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
11188213|NCT02111577|OG001|Outcome|Placebo With Standard of Care Chemotherapy|Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
11188214|NCT02111577|EG000|Reported Event|DCVAC/PCa With Standard of Care Chemotherapy|Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
11188215|NCT02111577|EG001|Reported Event|Placebo With Standard of Care Chemotherapy|Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
11188216|NCT02111603|BG000|Baseline|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
11188217|NCT02111603|FG000|Participant Flow|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
11188218|NCT02111603|OG000|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
11188219|NCT02111603|EG000|Reported Event|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
11188220|NCT02111746|BG000|Baseline|Exparel®|"Patients will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA).~Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.~Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day"
11239273|NCT02469610|FG000|Participant Flow|Study|"In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.~Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces."
11360716|NCT02499887|FG000|Participant Flow|Standard of Care|"Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)~Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.~albuterol: Inhaler~Prednisone: Oral corticosteroid"
11360717|NCT02499887|FG001|Participant Flow|Treatment|"Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days~Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.~beclamethasone dipropionate: Inhaler~albuterol: Inhaler~Prednisone: Oral corticosteroid"
11360718|NCT02499887|OG000|Outcome|Standard of Care|"Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)~Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.~albuterol: Inhaler~Prednisone: Oral corticosteroid"
11360719|NCT02499887|OG001|Outcome|Treatment|"Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days~Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.~beclamethasone dipropionate: Inhaler~albuterol: Inhaler~Prednisone: Oral corticosteroid"
11360720|NCT02499887|EG000|Reported Event|Standard of Care|"Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)~Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.~albuterol: Inhaler~Prednisone: Oral corticosteroid"
11360721|NCT02499887|EG001|Reported Event|Treatment|"Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days~Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.~beclamethasone dipropionate: Inhaler~albuterol: Inhaler~Prednisone: Oral corticosteroid"
11360722|NCT02504099|BG000|Baseline|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
11360723|NCT02504099|FG000|Participant Flow|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
11360724|NCT02504099|OG000|Outcome|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
11360725|NCT02504099|EG000|Reported Event|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
11188221|NCT02111746|BG001|Baseline|Regular Bupivacaine|"Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.~Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.~Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day"
11188222|NCT02111746|BG002|Baseline|Total|Total of all reporting groups
11360726|NCT02500901|BG000|Baseline|Experimental Treatment|"Enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.~Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.~Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented"
11360727|NCT02500901|FG000|Participant Flow|Experimental Treatment|"enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.~Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.~Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented"
11360728|NCT02500901|OG000|Outcome|Experimental Treatment|"enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.~Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.~Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented"
11360729|NCT02500901|EG000|Reported Event|Experimental Treatment|"enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.~Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.~Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented"
11360730|NCT02483533|BG000|Baseline|Experimental: LIPO-202|"Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.~LIPO-202"
11360731|NCT02483533|BG001|Baseline|Placebo Comparator: Placebo|"Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.~Placebo"
11360732|NCT02483533|BG002|Baseline|Total|Total of all reporting groups
11360733|NCT02483533|FG000|Participant Flow|Experimental: LIPO-202|"Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.~LIPO-202"
11360734|NCT02483533|FG001|Participant Flow|Placebo Comparator: Placebo|"Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.~Placebo"
11360735|NCT02483533|OG000|Outcome|Experimental: LIPO-202|"Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.~LIPO-202"
11360736|NCT02483533|OG001|Outcome|Placebo Comparator: Placebo|"Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.~Placebo"
11360737|NCT02483533|EG000|Reported Event|Experimental: LIPO-202|"Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.~LIPO-202"
11360738|NCT02483533|EG001|Reported Event|Placebo Comparator: Placebo|"Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.~Placebo"
11360739|NCT02496039|BG000|Baseline|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
11360740|NCT02496039|FG000|Participant Flow|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
11360741|NCT02496039|OG000|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
11360742|NCT02496039|EG000|Reported Event|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
11360743|NCT02492295|BG000|Baseline|Propofol|"Propofol: Propofol will be administered as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 (light sedation - awakens to voice <10 seconds) to RASS target of -3 (moderate sedation - movement or eye opening without eye contact) for 15 minutes. No more than 1.5mg/kg of propofol will be administered over this time period. After the sedation session is complete, patients will be allowed to wake up and will be monitored in the ED fo"
11360744|NCT02492295|FG000|Participant Flow|Propofol|"Propofol is administered intravenously as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 (light sedation - awakens to voice <10 seconds) to RASS target of -3 (moderate sedation - movement or eye opening without eye contact) for 15 minutes."
11360745|NCT02492295|OG000|Outcome|Propofol|"Propofol is administered intravenously as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 (light sedation - awakens to voice <10 seconds) to RASS target of -3 (moderate sedation - movement or eye opening without eye contact) for 15 minutes.~Pr"
11360746|NCT02492295|OG000|Outcome|Propofol|"Propofol is administered intravenously as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 (light sedation - awakens to voice <10 seconds) to RASS target of -3 (moderate sedation - movement or eye opening without eye contact) for 15 minutes."
11360747|NCT02492295|EG000|Reported Event|Propofol|"Propofol is administered intravenously as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 (light sedation - awakens to voice <10 seconds) to RASS target of -3 (moderate sedation - movement or eye opening without eye contact) for 15 minutes."
11239274|NCT02469610|FG001|Participant Flow|Control|"In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.~Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces."
11239275|NCT02469610|OG000|Outcome|Study|"In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.~Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces."
11239276|NCT02469610|OG001|Outcome|Control|"In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.~Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces."
11239277|NCT02469610|EG000|Reported Event|Study|"In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.~Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces."
11239278|NCT02469610|EG001|Reported Event|Control|"In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.~Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces."
11239279|NCT02469623|BG000|Baseline|Dipole Density Mapping|"Subjects scheduled for an ablation of a supraventricular tachycardia due to the arrhythmia being recurrent using the AcQMap High Resolution Imaging and Mapping System (AcQMap System) in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardias (SVTs).~Follow-up is 7-10 days for non-AF patients (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each patient."
11239280|NCT02469623|FG000|Participant Flow|Treated Subjects|Subjects scheduled for an ablation of a supraventricular tachycardia due to the arrhythmia being recurrent using the AcQMap High Resolution Imaging and Mapping System (AcQMap System) in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardias (SVTs).
11239281|NCT02469623|OG000|Outcome|Treated Subjects|Subjects scheduled for an ablation of a supraventricular tachycardia due to the arrhythmia being recurrent using the AcQMap High Resolution Imaging and Mapping System (AcQMap System) in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardias (SVTs).
11239282|NCT02469623|OG000|Outcome|Subjects Scheduled for Ablation of an SVT|Subjects scheduled for ablation of a supraventricular tachycardia (SVT) due to the arrhythmia being recurrent, poorly tolerated and/or unable to be controlled with antiarrhythmic drug therapy
11239283|NCT02469623|EG000|Reported Event|Treated Subjects|Subjects scheduled for an ablation of a supraventricular tachycardia due to the arrhythmia being recurrent using the AcQMap High Resolution Imaging and Mapping System (AcQMap System) in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardias (SVTs).
11239284|NCT02469701|BG000|Baseline|Nivolumab With Ablation|"3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.~Either cryoablation or thermal ablation may be performed as per standard institutional policies~nivolumab and ablation"
11239285|NCT02469701|FG000|Participant Flow|Nivolumab With Ablation|"3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.~Either cryoablation or thermal ablation may be performed as per standard institutional policies~nivolumab and ablation~As of amendment # 7 submitted to sites November 17, 2017, the dosing for Nivolumab per the FDA guidance was amended to a flat dose of 240mg IV Q2 weeks. As of amendment #8 sent to sites February 22, 2017 the dose of Nivolumab was updated to 3 mg/kg with a maximum dose of 240 mg for patients with weights that would correlate to exceed that dose instead of a flat dose secondary to the standard institutional practice and the FDA guidance ."
11239286|NCT02469701|OG000|Outcome|Nivolumab With Ablation|"3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.~Either cryoablation or thermal ablation may be performed as per standard institutional policies~nivolumab and ablation"
11239287|NCT02469701|EG000|Reported Event|Nivolumab With Ablation|"3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.~Either cryoablation or thermal ablation may be performed as per standard institutional policies~nivolumab and ablation~As of amendment # 7 submitted to sites November 17, 2017, the dosing for Nivolumab per the FDA guidance was amended to a flat dose of 240mg IV Q2 weeks. As of amendment #8 sent to sites February 22, 2017 the dose of Nivolumab was updated to 3 mg/kg with a maximum dose of 240 mg for patients with weights that would correlate to exceed that dose instead of a flat dose secondary to the standard institutional practice and the FDA guidance ."
11239288|NCT02469714|BG000|Baseline|Peer Navigator Intervention|"Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months.~Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group"
11239289|NCT02469714|BG001|Baseline|Controlled|Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
11239290|NCT02469714|BG002|Baseline|Total|Total of all reporting groups
11360748|NCT02494206|BG000|Baseline|QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)|"This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL).~QBX258: Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments."
11360749|NCT02494206|FG000|Participant Flow|QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)|"This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL).~QBX258: Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments."
11360750|NCT02494206|OG000|Outcome|QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)|"This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL).~QBX258: Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments."
11360751|NCT02494206|EG000|Reported Event|QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)|"This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL).~QBX258: Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments."
11360752|NCT02473445|BG000|Baseline|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
11360753|NCT02473445|FG000|Participant Flow|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
11360754|NCT02473445|OG000|Outcome|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
11360755|NCT02473445|EG000|Reported Event|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
11360756|NCT02491411|BG000|Baseline|Treatment (Dexamethasone and Enzalutamide)|"Patients receive dexamethasone PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of PSA progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11360757|NCT02491411|FG000|Participant Flow|Treatment (Dexamethasone and Enzalutamide)|"Patients receive dexamethasone PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of prostate specific antigen (PSA) progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11360758|NCT02491411|OG000|Outcome|Treatment (Dexamethasone and Enzalutamide)|"Patients receive dexamethasone PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of PSA progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11360759|NCT02491411|EG000|Reported Event|Treatment (Dexamethasone and Enzalutamide)|"Patients receive dexamethasone PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of PSA progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11360760|NCT02476994|BG000|Baseline|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
11360761|NCT02476994|BG001|Baseline|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
11360762|NCT02476994|BG002|Baseline|Total|Total of all reporting groups
11360763|NCT02476994|FG000|Participant Flow|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
11360764|NCT02476994|FG001|Participant Flow|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
11360765|NCT02476994|OG000|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
11360766|NCT02476994|OG001|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
11360767|NCT02476994|EG000|Reported Event|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
11360768|NCT02476994|EG001|Reported Event|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
11360769|NCT02473523|BG000|Baseline|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
11360770|NCT02473523|FG000|Participant Flow|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
11360771|NCT02473523|OG000|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
11360772|NCT02473523|EG000|Reported Event|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
11360773|NCT02468583|BG000|Baseline|FX006 32 mg|FX006: Single 5 mL IA injection
11360774|NCT02468583|BG001|Baseline|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11360775|NCT02468583|BG002|Baseline|Total|Total of all reporting groups
11360776|NCT02468583|FG000|Participant Flow|FX006 32 mg|3 subjects received FX006 32 mg as a single 5 mL IA injection
11360777|NCT02468583|FG001|Participant Flow|TCA IR 40 mg|3 subjects received TCA IR 40 mg as a single 1 mL IA injection
11360778|NCT02468583|OG000|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
11360779|NCT02468583|OG001|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11360780|NCT02468583|EG000|Reported Event|FX006 32 mg|FX006: Single 5 mL IA injection
11360781|NCT02468583|EG001|Reported Event|TCA IR 40 mg|TCA IR: Single 3 mL IA injection
11360782|NCT02450591|BG000|Baseline|Oligometastatic Non-Small Cell Lung Cancer|Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
11360783|NCT02450591|FG000|Participant Flow|Oligometastatic Non-Small Cell Lung Cancer|Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
11360784|NCT02450591|OG000|Outcome|Oligometastatic Non-Small Cell Lung Cancer|Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
11360785|NCT02450591|EG000|Reported Event|Oligometastatic Non-Small Cell Lung Cancer|Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
11360786|NCT02472639|BG000|Baseline|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
11360787|NCT02472639|BG001|Baseline|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
11360788|NCT02472639|BG002|Baseline|Total|Total of all reporting groups
11360789|NCT02472639|FG000|Participant Flow|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
11360790|NCT02472639|FG001|Participant Flow|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
11360791|NCT02472639|OG000|Outcome|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
11360792|NCT02472639|OG001|Outcome|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
11360793|NCT02472639|EG000|Reported Event|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
11360794|NCT02472639|EG001|Reported Event|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
11360795|NCT02469415|BG000|Baseline|Pacritinib + Azacitidine or Decitabine|"Pacritinib: Part 1: Pacritinib 200 mg taken by mouth twice daily.~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined therapy.~5-azacitidine: Part 2 Starting Dose of 5-azacitidine: 75 mg/m2 by vein on Days 1 - 5 of Cycles 5 and beyond.~Decitabine: Part 2 Starting Dose of Decitabine: 20 mg/m2 by vein on on Days 1 - 7 of Cycles 5 and beyond."
11360796|NCT02469415|FG000|Participant Flow|Pacritinib + Azacitidine or Decitabine|"Pacritinib: Part 1: Pacritinib 200 mg taken by mouth twice daily.~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined t"
11360797|NCT02469415|OG000|Outcome|Pacritinib + Azacitidine or Decitabine|"Pacritinib: Part 1: Pacritinib 200 mg taken by mouth twice daily.~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined t"
11360798|NCT02469415|EG000|Reported Event|Pacritinib + Azacitidine or Decitabine|"Pacritinib: Part 1: Pacritinib 200 mg taken by mouth twice daily.~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined t"
11360799|NCT02461550|BG000|Baseline|IRE Procedure|"The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.~Irreversible Electroporation Ablation"
11360800|NCT02461550|FG000|Participant Flow|IRE Procedure|"The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.~Irreversible Electroporation Ablation"
11360801|NCT02461550|OG000|Outcome|IRE Procedure|"The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.~Irreversible Electroporation Ablation"
11360802|NCT02461550|EG000|Reported Event|IRE Procedure|"The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.~Irreversible Electroporation Ablation"
11360803|NCT02461355|BG000|Baseline|All Participants|Includes participants who received anodal transcranial direct current stimulation (tDCS) or sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions.
11360804|NCT02461355|FG000|Participant Flow|All Participants|Includes participants who received anodal transcranial direct current stimulation (tDCS) or sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions.Since the PI left the institution and data on the cross-over assignment is not available for the 2 participants, data was reported on the collective whole and not on the treatment assignment per individual.
11360805|NCT02461355|OG000|Outcome|All Participants|Includes participants who received anodal tDCS or sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions.
11360806|NCT02461355|EG000|Reported Event|All Participants|Includes participants who received anodal tDCS or sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions.
11360807|NCT02452359|BG000|Baseline|Treatment Group|"Group receiving treatment with Venus Versa IPL energy~Venus Versa: The Venus Versa system consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers non-coherent light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated.In this study, the IPL applicator SR580 will be evaluated for the treatment of Striae Distensae, depending on the patient's skin type.~IPL gel: water based gel used to protect the skin during light based treatments. Is also commonly used during ultrasound treatments."
11360808|NCT02452359|FG000|Participant Flow|IPL 580 nm Treatment|Each subject to receive IPL applicator SR580 treatment of Striae Distensae either on the abdomen or thighs.
11360809|NCT02452359|OG000|Outcome|Treatment Group|"Group receiving treatment with Venus Versa IPL energy~Venus Versa: The Venus Versa system consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers non-coherent light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated.In this study, the IPL applicator SR580 will be evaluated for the treatment of Striae Distensae, depending on the patient's skin type.~IPL gel: water based gel used to protect the skin during light based treatments."
11360810|NCT02452359|EG000|Reported Event|IPL 580 nm Treatment|All subjects who received at least one IPL treatment.
11188223|NCT02111746|FG000|Participant Flow|Exparel®|"Patients will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA).~Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.~Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day"
11188224|NCT02111746|FG001|Participant Flow|Regular Bupivacaine|"Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.~Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.~Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day"
11188225|NCT02111746|OG000|Outcome|Exparel®|"Patients will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA).~Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.~Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day"
11188226|NCT02111746|OG001|Outcome|Regular Bupivacaine|"Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.~Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.~Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day"
11188227|NCT02111746|EG000|Reported Event|Exparel®|"Patients will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA).~Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.~Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day"
11188228|NCT02111746|EG001|Reported Event|Regular Bupivacaine|"Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.~Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.~Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day"
11188229|NCT02111772|BG000|Baseline|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
11188230|NCT02111772|BG001|Baseline|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
11188231|NCT02111772|BG002|Baseline|Total|Total of all reporting groups
11188232|NCT02111772|FG000|Participant Flow|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
11188233|NCT02111772|FG001|Participant Flow|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
11188234|NCT02111772|OG000|Outcome|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
11188235|NCT02111772|OG001|Outcome|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
11188236|NCT02111772|EG000|Reported Event|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
11360811|NCT02434146|BG000|Baseline|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
11360812|NCT02434146|FG000|Participant Flow|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
11360813|NCT02434146|OG000|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
11360814|NCT02434146|EG000|Reported Event|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
11360815|NCT02452398|BG000|Baseline|Hair Removal With Versa HR 690nm Applicator|Subjects with Fitzpatrick skin type V-VI requesting hair removal (right and left axillae and double sided bikini line) or one double sided large area (right and left thighs) or one large area (whole back / abdomen).
11360816|NCT02452398|FG000|Participant Flow|Treatment Group|"Hair removal treatment using Venus Versa IPL energy~Venus Versa: The Venus Versa system is a multi-application device intended to be used in aesthetic and cosmetic procedures.~The device consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated. The applicator that will be used for this study (HR 690) has a wavelength of 690 nm and has a spot size (treatment area) of 30 mm by 10 mm.~IPL gel: water based gel used to protect the skin during light based treatments. Also used during ultrasound treatments."
11360817|NCT02452398|OG000|Outcome|Treatment Group|Enrolled subjects acted as their own control. Each received Venus Versa IPL treatment to remove hair in marked treatment area.
11360818|NCT02452398|EG000|Reported Event|Hair Removal With Versa HR 690nm Applicator|All subjects who received at least one hair removal treatment with the Versa HR 690 nm applicator.
11360819|NCT02447887|BG000|Baseline|Ixazomib and Pegylated IFN Alfa - 2b|"Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.~Ixazomib: The prescribed administration of ixazomib doses in this study is 1.5-4.0 mg ixazomib weekly for 3 out of 4 weeks in each cycle (1 cycle=28 days).~Pegylated IFN-alpha 2b: Weekly injection"
11360820|NCT02447887|FG000|Participant Flow|Ixazomib and Pegylated IFN Alfa - 2b|"Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.~Ixazomib: The prescribed administration of ixazomib doses in this study is 1.5-4.0 mg ixazomib weekly for 3 out of 4 weeks in each cycle (1 cycle=28 days).~Pegylated IFN-alpha 2b: Weekly injection"
11360821|NCT02447887|OG000|Outcome|Ixazomib and Pegylated IFN Alfa - 2b|"Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.~Ixazomib: The prescribed administration of ixazomib doses in this study is 1.5-4.0 mg ixazomib weekly for 3 out of 4 weeks in each cycle (1 cycle=28 days).~Pegylated IFN-alpha 2b: Weekly injection"
11360822|NCT02447887|EG000|Reported Event|Ixazomib and Pegylated IFN Alfa - 2b|"Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.~Ixazomib: The prescribed administration of ixazomib doses in this study is 1.5-4.0 mg ixazomib weekly for 3 out of 4 weeks in each cycle (1 cycle=28 days).~Pegylated IFN-alpha 2b: Weekly injection"
11360823|NCT02431494|BG000|Baseline|BLP Arm (Blue Light Phototherapy)|"In this arm participants will receive 5 BLP sessions at 1 week intervals. The duration of each session will be approximately 20 minutes. At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes.~Blue light phototherapy: Blue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes."
11360824|NCT02431494|BG001|Baseline|MCT Arm (Microcurrent Therapy)|"In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated.~Microcurrent therapy: The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the statio"
11360825|NCT02431494|BG002|Baseline|Combination of BLP and Microcurrent|"In this arm participants will receive 5 BLP and 5 MCT sessions at 1 week intervals. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes.~Combination of BLP and Microcurrent: Same devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes."
11360826|NCT02431494|BG003|Baseline|Total|Total of all reporting groups
11360827|NCT02431494|FG000|Participant Flow|BLP Arm (Blue Light Phototherapy)|"In this arm participants will receive 5 BLP sessions at 1 week intervals. The duration of each session will be approximately 20 minutes. At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes.~Blue light phototherapy: Blue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes."
11360828|NCT02431494|FG001|Participant Flow|MCT Arm (Microcurrent Therapy)|"In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated.~Microcurrent therapy: The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the statio"
11360829|NCT02431494|FG002|Participant Flow|Combination of BLP and Microcurrent|"In this arm participants will receive 5 BLP and 5 MCT sessions at 1 week intervals. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes.~Combination of BLP and Microcurrent: Same devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes."
11360830|NCT02431494|OG000|Outcome|BLP Arm (Blue Light Phototherapy)|"In this arm participants will receive 5 BLP sessions at 1 week intervals. The duration of each session will be approximately 20 minutes. At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes.~Blue light phototherapy: Blue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes."
11360831|NCT02431494|OG001|Outcome|MCT Arm (Microcurrent Therapy)|"In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approx 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated.~Microcurrent therapy: Microcurrent therapy (Micro Current Electro-Device w/gloves and carrying case, SKU:DSE-X1008 Classic Spa Collection) The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the statio"
11360832|NCT02431494|OG002|Outcome|Combination of BLP and Microcurrent|"In this arm participants will receive 5 BLP and 5 MCT sessions at 1 week intervals. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes.~Combination of BLP and Microcurrent: Same devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes."
11360833|NCT02431494|OG001|Outcome|MCT Arm (Microcurrent Therapy)|"In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated.~Microcurrent therapy: The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the statio"
11360834|NCT02431494|OG001|Outcome|MCT Arm (Microcurrent Therapy)|"In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated.~Microcurrent therapy: Microcurrent therapy (Micro Current Electro-Device w/gloves and carrying case, SKU:DSE-X1008 Classic Spa Collection) The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the statio"
11360835|NCT02431494|EG000|Reported Event|BLP Arm (Blue Light Phototherapy)|"In this arm participants will receive 5 BLP sessions at 1 week intervals. The duration of each session will be approximately 20 minutes. At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes.~Blue light phototherapy: Blue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes."
11360836|NCT02431494|EG001|Reported Event|MCT Arm (Microcurrent Therapy)|"In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated.~Microcurrent therapy: The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the statio"
11360837|NCT02431494|EG002|Reported Event|Combination of BLP and Microcurrent|"In this arm participants will receive 5 BLP and 5 MCT sessions at 1 week intervals. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes.~Combination of BLP and Microcurrent: Same devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes."
11360838|NCT02439970|BG000|Baseline|Treatment 1|"BCV plus vGCV placebo~Brincidofovir"
11360839|NCT02439970|BG001|Baseline|Treatment 2|"vGCV plus BCV placebo~Valganciclovir"
11360840|NCT02439970|BG002|Baseline|Total|Total of all reporting groups
11360841|NCT02439970|FG000|Participant Flow|Treatment 1|100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.
11360842|NCT02439970|FG001|Participant Flow|Treatment 2|900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
11360843|NCT02439970|OG000|Outcome|Treatment 1|100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.
11360844|NCT02439970|OG001|Outcome|Treatment 2|900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
11360845|NCT02439970|EG000|Reported Event|Treatment 1|100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.
11360846|NCT02439970|EG001|Reported Event|Treatment 2|900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
11360847|NCT02439957|BG000|Baseline|Treatment 1|100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily.
11360848|NCT02439957|BG001|Baseline|Treatment 2|900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
11360849|NCT02439957|BG002|Baseline|Total|Total of all reporting groups
11360850|NCT02439957|FG000|Participant Flow|Treatment 1|100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placeo (2 tablets) once daily.
11360851|NCT02439957|FG001|Participant Flow|Treatment 2|900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
11360852|NCT02439957|OG000|Outcome|Treatment 1|100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily.
11360853|NCT02439957|OG001|Outcome|Treatment 2|900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
11360854|NCT02439957|EG000|Reported Event|Treatment 1|100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily.
11360855|NCT02439957|EG001|Reported Event|Treatment 2|900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
11360856|NCT02441036|BG000|Baseline|1-3 Hours Before Resection|Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection
11360857|NCT02441036|BG001|Baseline|1 Day Before Resection|Subjects will receive Ultherapy treatment 1 day prior to tissue resection
11360858|NCT02441036|BG002|Baseline|3 Days Before Resection|Subjects will receive Ultherapy treatment 3 days prior to tissue resection
11360859|NCT02441036|BG003|Baseline|7 Days Before Resection|Subjects will receive Ultherapy treatment 7 days prior to tissue resection
11360860|NCT02441036|BG004|Baseline|45 Days Before Resection|Subjects will receive Ultherapy treatment 45 days prior to tissue resection
11360861|NCT02441036|BG005|Baseline|Total|Total of all reporting groups
11360862|NCT02441036|FG000|Participant Flow|1-3 Hours Before Resection|Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection
11360863|NCT02441036|FG001|Participant Flow|1 Day Before Resection|Subjects will receive Ultherapy treatment 1 day prior to tissue resection
11360864|NCT02441036|FG002|Participant Flow|3 Days Before Resection|Subjects will receive Ultherapy treatment 3 days prior to tissue resection
11360865|NCT02441036|FG003|Participant Flow|7 Days Before Resection|Subjects will receive Ultherapy treatment 7 days prior to tissue resection
11360866|NCT02441036|FG004|Participant Flow|45 Days Before Resection|Subjects will receive Ultherapy treatment 45 days prior to tissue resection
11360867|NCT02441036|OG000|Outcome|1-3 Hours Before Resection|Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection
11360868|NCT02441036|OG001|Outcome|1 Day Before Resection|Subjects will receive Ultherapy treatment 1 day prior to tissue resection
11360869|NCT02441036|OG002|Outcome|3 Days Before Resection|Subjects will receive Ultherapy treatment 3 days prior to tissue resection
11360870|NCT02441036|OG003|Outcome|7 Days Before Resection|Subjects will receive Ultherapy treatment 7 days prior to tissue resection
11360871|NCT02441036|OG004|Outcome|45 Days Before Resection|Subjects will receive Ultherapy treatment 45 days prior to tissue resect
11360872|NCT02441036|OG004|Outcome|45 Days Before Resection|Subjects will receive Ultherapy treatment 45 days prior to tissue resection
11360873|NCT02441036|EG000|Reported Event|1-3 Hours Before Resection|Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection
11360874|NCT02441036|EG001|Reported Event|1 Day Before Resection|Subjects will receive Ultherapy treatment 1 day prior to tissue resection
11360875|NCT02441036|EG002|Reported Event|3 Days Before Resection|Subjects will receive Ultherapy treatment 3 days prior to tissue resection
11360876|NCT02441036|EG003|Reported Event|7 Days Before Resection|Subjects will receive Ultherapy treatment 7 days prior to tissue resection
11360877|NCT02441036|EG004|Reported Event|45 Days Before Resection|Subjects will receive Ultherapy treatment 45 days prior to tissue resection
11360878|NCT02436265|BG000|Baseline|Ropivacaine Only Group|Patients receiving caudals with local anesthetic, but no IV dexamethasone
11360879|NCT02436265|BG001|Baseline|Ropivaciane + IV Dexamethasone|Patients receiving caudals with local anesthetic +0/1mg/kg IV dexamethasone
11360880|NCT02436265|BG002|Baseline|Total|Total of all reporting groups
11360881|NCT02436265|FG000|Participant Flow|Group 1 Ropivacaine|"Group 1 Ropivacaine Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine~Ropivacaine: Ropivacaine only"
11360882|NCT02436265|FG001|Participant Flow|Group 2 Ropivacaine and Dexamethasone|"Group 2 Ropivacaine/dexamethasone Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine and 0.1mg/kg of intravenous dexamethasone immediately after caudal placement~Dexamethasone: IV dexamethasone~Ropivacaine: Ropivacaine only"
11360883|NCT02436265|OG000|Outcome|Ropivacaine Only|caudal analgesia with 0.2% ropivacaine only
11360884|NCT02436265|OG001|Outcome|Ropivaciane + IV Dexamethasone|Caudal analgesia with IV dexamethasone
11360885|NCT02436265|EG000|Reported Event|Ropivacaine Only|Caudal analgesia with 0.2% ropivacaine only
11360886|NCT02436265|EG001|Reported Event|Ropivacaine + IV Dexamethasone|Caudal analgesia with 0.2% ropivacaine only plus IV dexamethasone 0.1 mg/kg
11360887|NCT02429583|BG000|Baseline|Recombivax in HCV Infected Individuals|"Recombivax vaccine administered IM to HCV-infected individuals~Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment"
11360888|NCT02429583|BG001|Baseline|Recombivax in Healthy Volunteers|"Recombivax vaccine administered IM to healthy individuals~Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment"
11360889|NCT02429583|BG002|Baseline|Total|Total of all reporting groups
11360890|NCT02429583|FG000|Participant Flow|Recombivax in HCV Infected Individuals|"Recombivax vaccine administered IM to HCV-infected individuals~Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment"
11360891|NCT02429583|FG001|Participant Flow|Recombivax in Healthy Volunteers|"Recombivax vaccine administered IM to healthy individuals~Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment"
11360892|NCT02429583|OG000|Outcome|Recombivax in HCV Infected Individuals|"Recombivax vaccine administered IM to HCV-infected individuals~Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment"
11360893|NCT02429583|OG001|Outcome|Recombivax in Healthy Volunteers|"Recombivax vaccine administered IM to healthy individuals~Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment"
11360894|NCT02429583|EG000|Reported Event|Recombivax in HCV Infected Individuals|"Recombivax vaccine administered IM to HCV-infected individuals~Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment"
11360895|NCT02429583|EG001|Reported Event|Recombivax in Healthy Volunteers|"Recombivax vaccine administered IM to healthy individuals~Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment"
11360896|NCT02417870|BG000|Baseline|Aldesleukin|aldesleukin
11360897|NCT02417870|FG000|Participant Flow|Aldesleukin|aldesleukin
11360898|NCT02417870|OG000|Outcome|Aldesleukin|aldesleukin
11360899|NCT02417870|EG000|Reported Event|Aldesleukin|aldesleukin
11360900|NCT02430532|BG000|Baseline|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
11360901|NCT02430532|BG001|Baseline|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
11360902|NCT02430532|BG002|Baseline|Total|Total of all reporting groups
11360903|NCT02430532|FG000|Participant Flow|Placebo|BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
11360904|NCT02430532|FG001|Participant Flow|Tecfidera 240 mg BID|BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
11360905|NCT02430532|OG000|Outcome|Placebo|BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
11360906|NCT02430532|OG001|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
11360907|NCT02430532|OG000|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
11360908|NCT02430532|OG001|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
11360909|NCT02430532|EG000|Reported Event|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
11360910|NCT02430532|EG001|Reported Event|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
11239291|NCT02469714|FG000|Participant Flow|Peer Navigator Intervention|"Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months.~Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group"
11239292|NCT02469714|FG001|Participant Flow|Controlled|Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
11239293|NCT02469714|OG000|Outcome|Peer Navigator Intervention|"Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months.~Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group"
11239294|NCT02469714|OG001|Outcome|Controlled|Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
11239295|NCT02469714|EG000|Reported Event|Peer Navigator Intervention|"Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months.~Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group"
11239296|NCT02469714|EG001|Reported Event|Controlled|Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
11239297|NCT02469857|BG000|Baseline|Reltecimod (AB103) 0.5 mg/kg|Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes
11239298|NCT02469857|BG001|Baseline|Placebo|NaCl 0.9%, single IV infusion over approximately 10 minutes
11239299|NCT02469857|BG002|Baseline|Total|Total of all reporting groups
11239300|NCT02469857|FG000|Participant Flow|Reltecimod (AB103) 0.5 mg/kg|Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes
11239301|NCT02469857|FG001|Participant Flow|Placebo|NaCl 0.9%, single IV infusion over approximately 10 minutes
11239302|NCT02469857|OG000|Outcome|Reltecimod (AB103) 0.5 mg/kg|Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes
11239303|NCT02469857|OG001|Outcome|Placebo|NaCl 0.9%, single IV infusion over approximately 10 minutes
11239304|NCT02469857|OG000|Outcome|AB103 0.5 mg/kg|AB103 0.5 mg/kg, IV infusion, single dose
11239305|NCT02469857|OG001|Outcome|Placebo|NaCl 0.9%, IV infusion, single dose
11239306|NCT02469857|EG000|Reported Event|Reltecimod (AB103) 0.5 mg/kg|Reltecimod (AB103) 0.5 mg/kg, single IV infusion over approximately 10 minutes
11239307|NCT02469857|EG001|Reported Event|Placebo|NaCl 0.9%, single IV infusion over approximately 10 minutes
11239308|NCT02469870|BG000|Baseline|Autism Parent Trainer (APT)|Autism Parent Trainer (APT) Experimental Condition. Practiced Routines was a facilitated program. It was organized into four modules that included a total of seven videos ranging from 3-13 minutes each. The topics overlapped with those in the TR program, but included more explicit information on function-based strategies, as well as mindfulness practice. Participants were assigned six fillable forms, and provided supplemental data collection tools. Additional resources focused on mindfulness and PBS within family routines. Eighteen brief guided audio meditations were available to participants via the Practiced MindTM mobile application. The meditations focused on bringing the parents' awareness to both internal and external experiences and helping them act intentionally.
11239309|NCT02469870|BG001|Baseline|Teaching Routines (Control)|Teaching Routines was entirely self-directed. The program included eight modules with videos for each ranging 3 - 5 minutes in duration. The topics were antecedent-behavior-consequence method, creating task analyses, antecedent-based strategies, communication, reinforcement, teaching methods, and overcoming obstacles. Participants were assigned six activities using fillable forms and provided additional resources including examples, a glossary of terms, and a list of websites. No feedback was given to the parents apart from the automated completion responses. The participants were given access to the TR LMS for the duration of the study, but post and follow-up assessments were completed at 6 and 10 weeks (i.e., same as the PR condition).
11239310|NCT02469870|BG002|Baseline|Total|Total of all reporting groups
11239311|NCT02469870|FG000|Participant Flow|Autism Parent Trainer (APT)|"Autism Parent Trainer (APT) Experimental Condition.~Practiced Routines was a facilitated program. It was organized into four modules that included a total of seven videos ranging from 3-13 minutes each. The topics overlapped with those in the TR program, but included more explicit information on function-based strategies, as well as mindfulness practice. Participants were assigned six fillable forms, and provided supplemental data collection tools. Additional resources focused on mindfulness and PBS within family routines. Eighteen brief guided audio meditations were available to participants via the Practiced MindTM mobile application. The meditations focused on bringing the parents' awareness to both internal and external experiences and helping them act intentionally."
11239312|NCT02469870|FG001|Participant Flow|Teaching Routines (Control)|Teaching Routines was entirely self-directed. The program included eight modules with videos for each ranging 3 - 5 minutes in duration. The topics were antecedent-behavior-consequence method, creating task analyses, antecedent-based strategies, communication, reinforcement, teaching methods, and overcoming obstacles. Participants were assigned six activities using fillable forms and provided additional resources including examples, a glossary of terms, and a list of websites. No feedback was given to the parents apart from the automated completion responses. The participants were given access to the TR LMS for the duration of the study, but post and follow-up assessments were completed at 6 and 10 weeks (i.e., same as the PR condition).
11239313|NCT02469870|OG000|Outcome|Autism Parent Trainer (APT)|Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching.
11360911|NCT02428231|BG000|Baseline|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
11360912|NCT02428231|BG001|Baseline|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
11360913|NCT02428231|BG002|Baseline|Total|Total of all reporting groups
11360914|NCT02428231|FG000|Participant Flow|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg dimethyl fumarate (DMF) twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
11360915|NCT02428231|FG001|Participant Flow|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
11360916|NCT02428231|OG000|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
11360917|NCT02428231|OG001|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
11360918|NCT02428231|EG000|Reported Event|Standard 1-Week Titration Arm|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
11360919|NCT02428231|EG001|Reported Event|6-Week Titration Arm|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
11360920|NCT02424565|BG000|Baseline|Overall Participants|Total number of participants randomized and treated in the study.
11360921|NCT02424565|FG000|Participant Flow|First Test Balm Then Placebo Balm|2 ± 0.2 g of test balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package .
11360922|NCT02424565|FG001|Participant Flow|First Placebo Balm Then Test Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of test balm of 9g balm packed in each primary package .
11360923|NCT02424565|OG000|Outcome|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
11360924|NCT02424565|OG001|Outcome|Placebo Balm|2 ± 0.2 g of placebo balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
11360925|NCT02424565|EG000|Reported Event|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
11360926|NCT02424565|EG001|Reported Event|Placebo Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
11360927|NCT02413047|BG000|Baseline|Immunomodulator|"Azathioprine, 6 mercaptopurine or methotrexate.~Azathioprine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past.~6 mercaptopurine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past as an alternative to imuran~Methotrexate: Medication will be given in subcutaneous injection form once a week if the patient cannot take imuran or 6 mercaptopurine."
11360928|NCT02413047|FG000|Participant Flow|Immunomodulator|"Azathioprine, 6 mercaptopurine or methotrexate.~Azathioprine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past.~6 mercaptopurine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past as an alternative to imuran~Methotrexate: Medication will be given in subcutaneous injection form once a week if the patient cannot take imuran or 6 mercaptopurine."
11360929|NCT02413047|OG000|Outcome|Immunomodulator|"Azathioprine, 6 mercaptopurine or methotrexate.~Azathioprine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past.~6 mercaptopurine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past as an alternative to imuran~Methotrexate: Medication will be given in subcutaneous injection form once a week if the patient cannot take imuran or 6 mercaptopurine."
11360930|NCT02413047|EG000|Reported Event|Immunomodulator|"Azathioprine, 6 mercaptopurine or methotrexate.~Azathioprine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past.~6 mercaptopurine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past as an alternative to imuran~Methotrexate: Medication will be given in subcutaneous injection form once a week if the patient cannot take imuran or 6 mercaptopurine."
11360931|NCT02414698|BG000|Baseline|Percutaneous Hydrodiscectomy|"Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System~Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture."
11360932|NCT02414698|BG001|Baseline|TESI|"Transforaminal Epidural Steroid Injections~TESI: Transforaminal epidural steroid injections given in the lumbar spine."
11360933|NCT02414698|BG002|Baseline|Total|Total of all reporting groups
11360934|NCT02414698|FG000|Participant Flow|Percutaneous Hydrodiscectomy|"Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System~Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture."
11360935|NCT02414698|FG001|Participant Flow|TESI|"Transforaminal Epidural Steroid Injections~TESI: Transforaminal epidural steroid injections given in the lumbar spine."
11360936|NCT02414698|OG000|Outcome|Percutaneous Hydrodiscectomy|"Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System~Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture."
11360937|NCT02414698|OG001|Outcome|TESI|"Transforaminal Epidural Steroid Injections~TESI: Transforaminal epidural steroid injections given in the lumbar spine."
11360938|NCT02414698|EG000|Reported Event|Percutaneous Hydrodiscectomy|"Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System~Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture."
11360939|NCT02414698|EG001|Reported Event|TESI|"Transforaminal Epidural Steroid Injections~TESI: Transforaminal epidural steroid injections given in the lumbar spine."
11360940|NCT02422303|BG000|Baseline|Ketamine Group|"This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.~ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia."
11360941|NCT02422303|BG001|Baseline|No Ketamine Group|This group will not receive ketamine at induction of general anesthesia.
11360942|NCT02422303|BG002|Baseline|Total|Total of all reporting groups
11360943|NCT02422303|FG000|Participant Flow|Ketamine Group|"This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.~ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia."
11360944|NCT02422303|FG001|Participant Flow|No Ketamine Group|This group will not receive ketamine at induction of general anesthesia.
11360945|NCT02422303|OG000|Outcome|Ketamine Group|"This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.~ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia."
11360946|NCT02422303|OG001|Outcome|No Ketamine Group|This group will not receive ketamine at induction of general anesthesia.
11360947|NCT02422303|EG000|Reported Event|Ketamine Group|"This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.~ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia."
11360948|NCT02422303|EG001|Reported Event|No Ketamine Group|This group will not receive ketamine at induction of general anesthesia.
11360949|NCT02415166|BG000|Baseline|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
11360950|NCT02415166|BG001|Baseline|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
11360951|NCT02415166|BG002|Baseline|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
11360952|NCT02415166|BG003|Baseline|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
11360953|NCT02415166|BG004|Baseline|Total|Total of all reporting groups
11360954|NCT02415166|FG000|Participant Flow|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
11360955|NCT02415166|FG001|Participant Flow|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
11360956|NCT02415166|FG002|Participant Flow|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
11360957|NCT02415166|FG003|Participant Flow|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
11360958|NCT02415166|OG000|Outcome|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
11360959|NCT02415166|OG001|Outcome|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
11360960|NCT02415166|OG002|Outcome|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
11360961|NCT02415166|OG003|Outcome|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
11360962|NCT02415166|EG000|Reported Event|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
11360963|NCT02415166|EG001|Reported Event|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
11360964|NCT02415166|EG002|Reported Event|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
11360965|NCT02415166|EG003|Reported Event|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
11360966|NCT02414152|BG000|Baseline|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
11360967|NCT02414152|FG000|Participant Flow|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
11360968|NCT02414152|OG000|Outcome|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
11360969|NCT02414152|EG000|Reported Event|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
11239314|NCT02469870|OG001|Outcome|Teaching Routines (Control)|Teaching Routines was entirely self-directed. The program included eight modules with videos for each ranging 3 - 5 minutes in duration. The topics were antecedent-behavior-consequence method, creating task analyses, antecedent-based strategies, communication, reinforcement, teaching methods, and overcoming obstacles. Participants were assigned six activities using fillable forms and provided additional resources including examples, a glossary of terms, and a list of websites. No feedback was given to the parents apart from the automated completion responses. The participants were given access to the TR LMS for the duration of the study, but post and follow-up assessments were completed at 6 and 10 weeks (i.e., same as the PR condition).
11239315|NCT02469870|OG000|Outcome|Autism Parent Trainer (APT)|"Practiced Routines was a facilitated program. It was organized into four modules that included a total of seven videos ranging from 3-13 minutes each. The topics overlapped with those in the TR program, but included more explicit information on function-based strategies, as well as mindfulness practice. Participants were assigned six fillable forms, and provided supplemental data collection tools. Additional resources focused on mindfulness and PBS within family routines. Eighteen brief guided audio meditations were available to participants via the Practiced MindTM mobile application. The meditations focused on bringing the parents' awareness to both internal and external experiences and helping them act intentionally.~Autism Parent Trainer (APT): Experimental condition"
11239316|NCT02469870|OG001|Outcome|Teaching Routines (Control|"Teaching Routines was entirely self-directed. The program included eight modules with videos for each ranging 3 - 5 minutes in duration. The topics were antecedent-behavior-consequence method, creating task analyses, antecedent-based strategies, communication, reinforcement, teaching methods, and overcoming obstacles. Participants were assigned six activities using fillable forms and provided additional resources including examples, a glossary of terms, and a list of websites. No feedback was given to the parents apart from the automated completion responses. The participants were given access to the TR LMS for the duration of the study, but post and follow-up assessments were completed at 6 and 10 weeks (i.e., same as the PR condition).~Teaching Routines (Control): Content comparison group."
11239317|NCT02469870|OG000|Outcome|Autism Parent Trainer (APT)|"Autism Parent Trainer (APT) Experimental Condition.~Practiced Routines was a facilitated program. It was organized into four modules that included a total of seven videos ranging from 3-13 minutes each. The topics overlapped with those in the TR program, but included more explicit information on function-based strategies, as well as mindfulness practice. Participants were assigned six fillable forms, and provided supplemental data collection tools. Additional resources focused on mindfulness and PBS within family routines. Eighteen brief guided audio meditations were available to participants via the Practiced MindTM mobile application. The meditations focused on bringing the parents' awareness to both internal and external experiences and helping them act intentionally."
11239318|NCT02469870|EG000|Reported Event|Autism Parent Trainer (APT)|"Autism Parent Trainer (APT) Experimental Condition.~Practiced Routines was a facilitated program. It was organized into four modules that included a total of seven videos ranging from 3-13 minutes each. The topics overlapped with those in the TR program, but included more explicit information on function-based strategies, as well as mindfulness practice. Participants were assigned six fillable forms, and provided supplemental data collection tools. Additional resources focused on mindfulness and PBS within family routines. Eighteen brief guided audio meditations were available to participants via the Practiced MindTM mobile application. The meditations focused on bringing the parents' awareness to both internal and external experiences and helping them act intentionally."
11239319|NCT02469870|EG001|Reported Event|Teaching Routines (Control)|Teaching Routines was entirely self-directed. The program included eight modules with videos for each ranging 3 - 5 minutes in duration. The topics were antecedent-behavior-consequence method, creating task analyses, antecedent-based strategies, communication, reinforcement, teaching methods, and overcoming obstacles. Participants were assigned six activities using fillable forms and provided additional resources including examples, a glossary of terms, and a list of websites. No feedback was given to the parents apart from the automated completion responses. The participants were given access to the TR LMS for the duration of the study, but post and follow-up assessments were completed at 6 and 10 weeks (i.e., same as the PR condition).
11239320|NCT02469896|BG000|Baseline|Placebo|"8 subjects will receive matching IV placebo every 4 weeks for 3 months.~Placebo: IV Infusion"
11239321|NCT02469896|BG001|Baseline|Active Drug|"16 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months.~Tocilizumab: IV Infusion"
11239322|NCT02469896|BG002|Baseline|Total|Total of all reporting groups
11239323|NCT02469896|FG000|Participant Flow|Placebo|"8 subjects will receive matching IV placebo every 4 weeks for 3 months.~Placebo: IV Infusion"
11239324|NCT02469896|FG001|Participant Flow|Active Drug|"16 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months.~Tocilizumab: IV Infusion"
11239325|NCT02469896|OG000|Outcome|Placebo Tolerability|"8 subjects will receive matching IV placebo every 4 weeks for 3 months.~Placebo: IV Infusion"
11239326|NCT02469896|OG001|Outcome|Active Drug Tolerability|"14 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months.~Tocilizumab: IV Infusion"
11239327|NCT02469896|OG000|Outcome|Placebo|"8 subjects will receive matching IV placebo every 4 weeks for 3 months.~Placebo: IV Infusion"
11239328|NCT02469896|OG001|Outcome|Active Drug|"14 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months.~Tocilizumab: IV Infusion"
11239329|NCT02469896|OG001|Outcome|Active Drug|"16 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months.~Tocilizumab: IV Infusion"
11239330|NCT02469896|OG001|Outcome|Active Drug|"14subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months.~Tocilizumab: IV Infusion"
11239331|NCT02469896|EG000|Reported Event|Placebo|"8 subjects will receive matching IV placebo every 4 weeks for 3 months.~Placebo: IV Infusion"
11239332|NCT02469896|EG001|Reported Event|Active Drug|"16 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months.~Tocilizumab: IV Infusion"
11239333|NCT02469961|BG000|Baseline|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11360970|NCT02410551|BG000|Baseline|Pacritinib Pre- Transplant|Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than
11360971|NCT02410551|FG000|Participant Flow|Pacritinib Pre- Transplant|Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than 180 days
11360972|NCT02410551|OG000|Outcome|Pacritinib Pre- Transplant|Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than
11360973|NCT02410551|OG000|Outcome|Pacritinib Pre- Transplant|Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than 180 days
11360974|NCT02410551|EG000|Reported Event|Pacritinib Pre- Transplant|Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than
11360975|NCT02411643|BG000|Baseline|Topical Calcipotriene 0.005% Ointment|"Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects~topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months"
11360976|NCT02411643|FG000|Participant Flow|Topical Calcipotriene 0.005% Ointment|"Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects~topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months"
11360977|NCT02411643|OG000|Outcome|Topical Calcipotriene 0.005% Ointment|"Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects~topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months"
11360978|NCT02411643|EG000|Reported Event|Topical Calcipotriene 0.005% Ointment|"Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects~topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months"
11360979|NCT02410954|BG000|Baseline|tDCS Electrode Configuration|"Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)~NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response."
11360980|NCT02410954|BG001|Baseline|Using tDCS to Reduce Acute Fear|"Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.~NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response."
11360981|NCT02410954|BG002|Baseline|Total|Total of all reporting groups
11360982|NCT02410954|FG000|Participant Flow|tDCS Electrode Configuration|"Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)~NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response."
11360983|NCT02410954|FG001|Participant Flow|Using tDCS to Reduce Acute Fear|"Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.~NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response."
11360984|NCT02410954|OG000|Outcome|tDCS Electrode Configuration|"Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)~NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response."
11360985|NCT02410954|OG001|Outcome|Using tDCS to Reduce Acute Fear|"Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.~NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response."
11360986|NCT02410954|EG000|Reported Event|tDCS Electrode Configuration|"Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)~NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response."
11360987|NCT02410954|EG001|Reported Event|Using tDCS to Reduce Acute Fear|"Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.~NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response."
11360988|NCT02410577|BG000|Baseline|89Zr-J591|"Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.~89Zr-J591: The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.~PET/CT Scan~MRI~Blood draw: Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection."
11188237|NCT02111772|EG001|Reported Event|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
11188238|NCT02111785|BG000|Baseline|Burr Hole Craniostomy Randomized|"Group receiving burr hole craniostomy and drainage of chronic subdural hematoma~Burr Hole Craniostomy"
11188239|NCT02111785|BG001|Baseline|Dexamethasone Randomized|"Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days~Dexamethasone"
11188240|NCT02111785|BG002|Baseline|Burr Hole Craniostomy Observational|"Observational cohort of patients selecting burr hole craniostomy~Burr Hole Craniostomy"
11188241|NCT02111785|BG003|Baseline|Dexamethasone Observational|"Observational cohort of patients treated with dexamethasone protocol~Dexamethasone"
11188242|NCT02111785|BG004|Baseline|Total|Total of all reporting groups
11188243|NCT02111785|FG000|Participant Flow|Burr Hole Craniostomy Randomized|"Group receiving burr hole craniostomy and drainage of chronic subdural hematoma~Burr Hole Craniostomy"
11188244|NCT02111785|FG001|Participant Flow|Dexamethasone Randomized|"Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days~Dexamethasone"
11188245|NCT02111785|FG002|Participant Flow|Burr Hole Craniostomy Observational|"Observational cohort of patients selecting burr hole craniostomy~Burr Hole Craniostomy"
11188246|NCT02111785|FG003|Participant Flow|Dexamethasone Observational|"Observational cohort of patients treated with dexamethasone protocol~Dexamethasone"
11188247|NCT02111785|OG000|Outcome|Burr Hole Craniostomy Randomized|"Group receiving burr hole craniostomy and drainage of chronic subdural hematoma~Burr Hole Craniostomy"
11188248|NCT02111785|OG001|Outcome|Dexamethasone Randomized|"Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days~Dexamethasone"
11188249|NCT02111785|OG002|Outcome|Burr Hole Craniostomy Observational|"Observational cohort of patients selecting burr hole craniostomy~Burr Hole Craniostomy"
11188250|NCT02111785|OG003|Outcome|Dexamethasone Observational|"Observational cohort of patients treated with dexamethasone protocol~Dexamethasone"
11188251|NCT02111785|OG000|Outcome|Burr Hole Craniostomy Randomized|"Group receiving burr hole craniostomy and drainage of chronic subdural hematoma~Burr Hole Craniostomy: Treatment with surgical burr hole craniostomy and evacuation of SDH"
11188252|NCT02111785|OG001|Outcome|Dexamethasone Randomized|"Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days~Dexamethasone: Treatment with a short course of oral dexamethasone"
11188253|NCT02111785|OG002|Outcome|Burr Hole Craniostomy Observational|"Observational cohort of patients selecting burr hole craniostomy~Burr Hole Craniostomy: Treatment with surgical burr hole craniostomy and evacuation of SDH"
11188254|NCT02111785|OG003|Outcome|Dexamethasone Observational|"Observational cohort of patients treated with dexamethasone protocol~Dexamethasone: Treatment with a short course of oral dexamethasone"
11188255|NCT02111785|EG000|Reported Event|Burr Hole Craniostomy Randomized|"Group receiving burr hole craniostomy and drainage of chronic subdural hematoma~Burr Hole Craniostomy"
11188256|NCT02111785|EG001|Reported Event|Dexamethasone Randomized|"Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days~Dexamethasone"
11188257|NCT02111785|EG002|Reported Event|Burr Hole Craniostomy Observational|"Observational cohort of patients selecting burr hole craniostomy~Burr Hole Craniostomy"
11188258|NCT02111785|EG003|Reported Event|Dexamethasone Observational|"Observational cohort of patients treated with dexamethasone protocol~Dexamethasone"
11188259|NCT02111798|BG000|Baseline|Placebo/Abstinence Initiation|Twice daily capsules filled with placebo powder + participants who did not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188260|NCT02111798|BG001|Baseline|Bupropion XL/Abstinence Initiation|Twice daily capsules filled with bupropion 150mg + participants who did not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188261|NCT02111798|BG002|Baseline|Placebo/Relapse Prevention|Twice daily capsules filled with placebo powder + participants who did provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188262|NCT02111798|BG003|Baseline|Bupropion XL/Relapse Prevention|Twice daily capsules filled with bupropion 150mg + participants who did provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188263|NCT02111798|BG004|Baseline|Total|Total of all reporting groups
11188264|NCT02111798|FG000|Participant Flow|Placebo/Abstinence Initiation|Twice daily capsules filled with placebo powder + participants who did not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188265|NCT02111798|FG001|Participant Flow|Bupropion XL/Abstinence Initiation|Twice daily capsules filled with bupropion extended release, 150mg (300mg daily) + participants who did not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188266|NCT02111798|FG002|Participant Flow|Placebo/Relapse Prevention|Twice daily capsules filled with placebo + participants who provided >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188267|NCT02111798|FG003|Participant Flow|Bupropion XL/Relapse Prevention|Twice daily capsules filled with bupropion extended release, 150mg (300mg daily) + participants who did provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188268|NCT02111798|OG000|Outcome|Placebo/Abstinence Initiation|Twice daily capsules filled with placebo powder + participants who did not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188269|NCT02111798|OG001|Outcome|Bupropion XL/Abstinence Initiation|Twice daily capsules filled with bupropion XL 150mg + participants who did not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188270|NCT02111798|OG002|Outcome|Placebo/Relapse Prevention|Twice daily capsules filled with placebo powder + participants who did provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188271|NCT02111798|OG003|Outcome|Bupropion XL/Relapse Prevention|Twice daily capsules filled with bupropion XL 150mg + participants who not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188272|NCT02111798|OG003|Outcome|Bupropion XL/Relapse Prevention|Twice daily capsules filled with bupropion Xl 150mg + participants who did provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188273|NCT02111798|EG000|Reported Event|Placebo/Abstinence Initiation|Twice daily capsules filled with placebo powder + participants who did not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188274|NCT02111798|EG001|Reported Event|Bupropion XL/Abstinence Initiation|Twice daily capsules filled with bupropion XL 150mg + participants who did not provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11239334|NCT02469961|BG001|Baseline|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with propofol and compared to sedation with Dexmedetomidine~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11239335|NCT02469961|BG002|Baseline|Total|Total of all reporting groups
11239336|NCT02469961|FG000|Participant Flow|Dexmedetomidne|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11239337|NCT02469961|FG001|Participant Flow|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11239338|NCT02469961|OG000|Outcome|Dexmedetomidine|Number of patients required airway manipulation
11239339|NCT02469961|OG001|Outcome|Propofol|Number of patients required airway manipulations
11239340|NCT02469961|OG000|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11239341|NCT02469961|OG001|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11239342|NCT02469961|OG000|Outcome|Propofol|Patients who received Propofol
11239343|NCT02469961|OG001|Outcome|Dexmedetomidine|Patients who received Dexmedetomidine
11239344|NCT02469961|OG001|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11239345|NCT02469961|EG000|Reported Event|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11239346|NCT02469961|EG001|Reported Event|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
11239347|NCT02470234|BG000|Baseline|Methylphenidate HCl ER 10 mg|Subjects received a single dose of Methylphenidate HCl ER 10 mg
11239348|NCT02470234|BG001|Baseline|Methylphenidate HCl ER 15 mg|Subjects received a single dose of Methylphenidate HCl ER 15 mg
11239349|NCT02470234|BG002|Baseline|Methylphenidate HCl ER 20 mg|Subjects received a single dose of Methylphenidate HCl ER 20 mg
11239350|NCT02470234|BG003|Baseline|Total|Total of all reporting groups
11239351|NCT02470234|FG000|Participant Flow|Methylphenidate HCl ER 10 mg|Subjects received a single dose of Methylphenidate HCl ER 10 mg . This dose was equivalent to their current total daily methylphenidate dose.
11239352|NCT02470234|FG001|Participant Flow|Methylphenidate HCl ER 15 mg|Subjects received a single dose of Methylphenidate HCl ER 15 mg . This dose was equivalent to their current total daily methylphenidate dose.
11239353|NCT02470234|FG002|Participant Flow|Methylphenidate HCl ER 20 mg|Subjects received a single dose of Methylphenidate HCl ER 20 mg . This dose was equivalent to their current total daily methylphenidate dose.
11239354|NCT02470234|OG000|Outcome|Methylphenidate HCl ER 10 mg|"Active drug, administered once~Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions"
11239355|NCT02470234|OG001|Outcome|Methylphenidate HCl ER 15 mg|"Active drug, administered once~Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions"
11239356|NCT02470234|OG002|Outcome|Methylphenidate HCl ER 20 mg|"Active drug, administered once~Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions"
11239357|NCT02470234|OG000|Outcome|Methylphenidate HCl ER 10 mg|"Active drug, administered once~Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions."
11239358|NCT02470234|OG001|Outcome|Methylphenidate HCl ER 15 mg|"Active drug, administered once~Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions."
11239359|NCT02470234|OG002|Outcome|Methylphenidate HCl ER 20 mg|"Active drug, administered once~Methylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions."
11239360|NCT02470234|OG002|Outcome|Methylphenidate HCl ER 20 mg Capsule|"Active drug, administered once~Methylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions."
11239361|NCT02470234|OG000|Outcome|Methylphenidate HCl ER 10 mg|"Active drug, administered once~Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.~."
11239362|NCT02470234|EG000|Reported Event|Methylphenidate HCl ER 10 mg|Subjects received a single dose of Methylphenidate HCl ER 10 mg
11239363|NCT02470234|EG001|Reported Event|Methylphenidate HCl ER 15 mg|Subjects received a single dose of Methylphenidate HCl ER 15 mg
11239364|NCT02470234|EG002|Reported Event|Methylphenidate HCl ER 20 mg|Subjects received a single dose of Methylphenidate HCl ER 20 mg
11188275|NCT02111798|EG002|Reported Event|Placebo/Relapse Prevention|Twice daily capsules filled with placebo powder + participants who did provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188276|NCT02111798|EG003|Reported Event|Bupropion XL/Relapse Prevention|Twice daily capsules filled with bupropion XL 150mg + participants who did provide >/=3 consecutive negative urine samples during weeks 1-6 of the trial
11188277|NCT02111811|BG000|Baseline|Veterans Work and Health Initiative|"Integrated care services plus a CBT based intervention focused on work productivity~Veterans Work and Health Initiative: CBT based intervention focused on work productivity"
11188278|NCT02111811|BG001|Baseline|Integreated Care Only|usual care group (Integrated care services only)
11188279|NCT02111811|BG002|Baseline|Total|Total of all reporting groups
11188280|NCT02111811|FG000|Participant Flow|Veterans Work and Health Initiative|"Integrated care services plus a CBT based intervention focused on work productivity~Veterans Work and Health Initiative: CBT based intervention focused on work productivity"
11188281|NCT02111811|FG001|Participant Flow|Integreated Care Only|usual care group (Integrated care services only)
11188282|NCT02111811|OG000|Outcome|Veterans Work and Health Initiative|"Integrated care services plus a CBT based intervention focused on work productivity~Veterans Work and Health Initiative: CBT based intervention focused on work productivity"
11188283|NCT02111811|OG001|Outcome|Integreated Care Only|usual care group (Integrated care services only)
11188284|NCT02111811|EG000|Reported Event|Veterans Work and Health Initiative|"Integrated care services plus a CBT based intervention focused on work productivity~Veterans Work and Health Initiative: CBT based intervention focused on work productivity"
11188285|NCT02111811|EG001|Reported Event|Integreated Care Only|usual care group (Integrated care services only)
11188286|NCT02111863|BG000|Baseline|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
11188287|NCT02111863|FG000|Participant Flow|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
11188288|NCT02111863|OG000|Outcome|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
11188289|NCT02111863|EG000|Reported Event|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
11188290|NCT02111980|BG000|Baseline|RF Assure Scanning|Cardiac implantable electronic device (CIED) (implantable cardiac defibrillator (ICD) and permanent pacemakers (PPM)) and temporary pacemaker patients (during pulmonary thromboendartectomy (PTE) surgery) were scanned with the Radiofrequency (RF) surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology.
11239365|NCT02470312|BG000|Baseline|CRT Group|All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
11239366|NCT02470312|BG001|Baseline|EP Group|All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
11360989|NCT02410577|FG000|Participant Flow|89Zr-J591|"Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.~89Zr-J591: The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.~PET/CT Scan~MRI~Blood draw: Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection."
11360990|NCT02410577|OG000|Outcome|89Zr-J591|"Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.~89Zr-J591: The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.~PET/CT Scan~MRI~Blood draw: Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection."
11360991|NCT02410577|EG000|Reported Event|89Zr-J591|"Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.~89Zr-J591: The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.~PET/CT Scan~MRI~Blood draw: Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection."
11360992|NCT02409355|BG000|Baseline|Atezolizumab|Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
11360993|NCT02409355|BG001|Baseline|Gemcitabine + Cisplatin/Carboplatin|Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
11360994|NCT02409355|BG002|Baseline|Total|Total of all reporting groups
11360995|NCT02409355|FG000|Participant Flow|Atezolizumab|Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
11360996|NCT02409355|FG001|Participant Flow|Gemcitabine + Cisplatin/Carboplatin|Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
11360997|NCT02409355|OG000|Outcome|Atezolizumab|Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
11360998|NCT02409355|OG001|Outcome|Gemcitabine + Cisplatin/Carboplatin|Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
11360999|NCT02409355|EG000|Reported Event|Atezolizumab|Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
11188291|NCT02111980|FG000|Participant Flow|RF Assure Scanning|"The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.~RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning."
11361000|NCT02409355|EG001|Reported Event|Gemcitabine + Cisplatin/Carboplatin|Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
11361001|NCT02403154|BG000|Baseline|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
11361002|NCT02403154|BG001|Baseline|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
11361003|NCT02403154|BG002|Baseline|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
11239367|NCT02470312|BG002|Baseline|Total|Total of all reporting groups
11239368|NCT02470312|FG000|Participant Flow|CRT Group|All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
11239369|NCT02470312|FG001|Participant Flow|EP Group|All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
11239370|NCT02470312|OG000|Outcome|CRT Group|All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
11239371|NCT02470312|OG001|Outcome|EP Group|All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
11239372|NCT02470312|EG000|Reported Event|CRT Group|All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
11239373|NCT02470312|EG001|Reported Event|EP Group|All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
11239374|NCT02470390|BG000|Baseline|Nasal Fentanyl First, Then Sublingual Fentanyl and IV Fentanyl|"Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 per protocol.~Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 3 per protocol.~IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol."
11239375|NCT02470390|BG001|Baseline|Sublingual Fentanyl First, Then Nasal Fentanyl and IV Fentanyl|"Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 per protocol.~Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 3 per protocol.~IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol."
11239376|NCT02470390|BG002|Baseline|Total|Total of all reporting groups
11239377|NCT02470390|FG000|Participant Flow|Nasal Fentanyl First, Then Sublingual Fentanyl and IV Fentanyl|"Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 per protocol.~Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 3 per protocol.~IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol."
11239378|NCT02470390|FG001|Participant Flow|Sublingual Fentanyl First, Then Nasal Fentanyl and IV Fentanyl|"Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 per protocol.~Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 3 per protocol.~IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol."
11239379|NCT02470390|OG000|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
11239380|NCT02470390|OG001|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
11239381|NCT02470390|OG002|Outcome|IV Fentanyl|IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.
11239382|NCT02470390|EG000|Reported Event|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
11239383|NCT02470390|EG001|Reported Event|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
11239384|NCT02470390|EG002|Reported Event|IV Fentanyl|IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.
11239385|NCT02470403|BG000|Baseline|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
11239386|NCT02470403|BG001|Baseline|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
11239387|NCT02470403|BG002|Baseline|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
11239388|NCT02470403|BG003|Baseline|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
11239389|NCT02470403|BG004|Baseline|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
11239390|NCT02470403|BG005|Baseline|Total|Total of all reporting groups
11239391|NCT02470403|FG000|Participant Flow|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
11239392|NCT02470403|FG001|Participant Flow|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
11239393|NCT02470403|FG002|Participant Flow|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
11239394|NCT02470403|FG003|Participant Flow|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
11239395|NCT02470403|FG004|Participant Flow|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
11239396|NCT02470403|OG000|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
11239397|NCT02470403|OG001|Outcome|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
11239398|NCT02470403|OG001|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
11239399|NCT02470403|OG002|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
11239400|NCT02470403|OG003|Outcome|Part 1 and 2 : Pooled Placebo|Placebo subjects were pooled between the 2 parts and were considered a single treatment arm for the analyses
11239401|NCT02470403|OG000|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
11239402|NCT02470403|OG001|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
11239403|NCT02470403|OG002|Outcome|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
11239404|NCT02470403|EG000|Reported Event|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
11239405|NCT02470403|EG001|Reported Event|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
11239406|NCT02470403|EG002|Reported Event|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
11239407|NCT02470403|EG003|Reported Event|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
11239408|NCT02470403|EG004|Reported Event|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
11239409|NCT02470429|BG000|Baseline|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
11239410|NCT02470429|BG001|Baseline|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
11239411|NCT02470429|BG002|Baseline|Total|Total of all reporting groups
11239412|NCT02470429|FG000|Participant Flow|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
11239413|NCT02470429|FG001|Participant Flow|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
11239414|NCT02470429|OG000|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
11239415|NCT02470429|OG001|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
11239416|NCT02470429|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11239417|NCT02470429|EG001|Reported Event|SYSTANE HYDRATION|All subjects treated with SYSTANE HYDRATION lubricant eye drops
11239418|NCT02470429|EG002|Reported Event|Hyabak 0.15%|All subjects treated with Hyabak 0.15% eye drops
11239419|NCT02470494|BG000|Baseline|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
11239420|NCT02470494|FG000|Participant Flow|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
11239421|NCT02470494|OG000|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
11239422|NCT02470494|EG000|Reported Event|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
11239423|NCT02470741|BG000|Baseline|Letrozole|Oral letrozole 2.5mg/day
11239424|NCT02470741|BG001|Baseline|Placebo and Letrozole|Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
11239425|NCT02470741|BG002|Baseline|Total|Total of all reporting groups
11239426|NCT02470741|FG000|Participant Flow|Letrozole|Oral letrozole 2.5mg/day
11239427|NCT02470741|FG001|Participant Flow|Placebo and Letrozole|Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
11239428|NCT02470741|OG000|Outcome|Letrozole|Oral letrozole 2.5mg/day
11239429|NCT02470741|OG001|Outcome|Placebo and Letrozole|Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
11239430|NCT02470741|EG000|Reported Event|Letrozole|Oral letrozole 2.5mg/day
11239431|NCT02470741|EG001|Reported Event|Placebo and Letrozole|Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
11239432|NCT02470754|BG000|Baseline|Completers|all completed
11239433|NCT02470754|FG000|Participant Flow|EC Block1/TC Block 2|"Participants will be randomized into one of two groups. In this group, participants will be assigned to Electronic Cigarettes only for Study Block #1, then crossover to Tobacco Cigarettes only for Study Block #2.~Tobacco Cigarette: Usual brand tobacco cigarette smoked by study participant.~Electronic Cigarette: Usual brand electronic cigarettes smoked by study participant."
11239434|NCT02470754|FG001|Participant Flow|TC Block 1/EC Block 2|"Participants will be randomized into one of two groups. In this group, participants will be assigned to Tobacco Cigarettes only for Study Block #1, then crossover to Electronic Cigarettes only for Study Block #2.~Tobacco Cigarette: Usual brand tobacco cigarette smoked by study participant.~Electronic Cigarette: Usual brand electronic cigarettes smoked by study participant."
11239435|NCT02470754|OG000|Outcome|Electronic Cigarette|EC ARM
11239436|NCT02470754|OG001|Outcome|Combustible Cigarette|TC ARM
11239437|NCT02470754|EG000|Reported Event|Electronic Cigarette|Electronic cigarette ARM
11239438|NCT02470754|EG001|Reported Event|Combustible Cigarette|Tobacco Cigarette ARM
11239439|NCT02470806|BG000|Baseline|PICO System|Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
11239440|NCT02470806|BG001|Baseline|tNPWT System|Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
11239441|NCT02470806|BG002|Baseline|Total|Total of all reporting groups
10962128|NCT00865020|FG000|Participant Flow|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
10962129|NCT00865020|FG001|Participant Flow|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
11188292|NCT02111980|OG000|Outcome|Pre-Scan Measures for PPM/ICDs Scanned With RF Assure|"The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.~RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning."
11188293|NCT02111980|OG001|Outcome|Post-Scan Measures for PPM/ICDs Scanned With RF Assure|The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
11188294|NCT02111980|OG000|Outcome|Pre-Scan Measures for ICDs Scanned With RF Assure|"The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.~RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning."
11188295|NCT02111980|OG001|Outcome|Post-Scan Measures for ICDs Scanned With RF Assure|The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.
11188296|NCT02111980|EG000|Reported Event|RF Assure Scanning|"The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.~RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning."
11188297|NCT02111993|BG000|Baseline|Standard Defibrillation Testing|"Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.~Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes."
11188298|NCT02111993|BG001|Baseline|Upper Limit of VulnerabilityTesting|"Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.~Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered."
11188299|NCT02111993|BG002|Baseline|Total|Total of all reporting groups
11239442|NCT02470806|FG000|Participant Flow|PICO System|Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
11239443|NCT02470806|FG001|Participant Flow|tNPWT System|Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
11239444|NCT02470806|OG000|Outcome|PICO System|Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
11239445|NCT02470806|OG001|Outcome|tNPWT System|Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
11239446|NCT02470806|EG000|Reported Event|PICO System|Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
11361004|NCT02403154|BG003|Baseline|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
11361005|NCT02403154|BG004|Baseline|Total|Total of all reporting groups
11361006|NCT02403154|FG000|Participant Flow|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
11361007|NCT02403154|FG001|Participant Flow|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
11361008|NCT02403154|FG002|Participant Flow|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
11361009|NCT02403154|FG003|Participant Flow|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
11188300|NCT02111993|FG000|Participant Flow|Standard Defibrillation Testing|"Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.~Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes."
11361010|NCT02403154|OG000|Outcome|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
11361011|NCT02403154|OG001|Outcome|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
11361012|NCT02403154|OG002|Outcome|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
11361013|NCT02403154|OG003|Outcome|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
11361014|NCT02403154|EG000|Reported Event|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
11361015|NCT02403154|EG001|Reported Event|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
11361016|NCT02403154|EG002|Reported Event|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
11361017|NCT02403154|EG003|Reported Event|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
11361018|NCT02404545|BG000|Baseline|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
11361019|NCT02404545|BG001|Baseline|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
11361020|NCT02404545|BG002|Baseline|Total|Total of all reporting groups
11361021|NCT02404545|FG000|Participant Flow|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
11361022|NCT02404545|FG001|Participant Flow|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
11361023|NCT02404545|OG000|Outcome|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
11361024|NCT02404545|OG001|Outcome|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
11361025|NCT02404545|OG000|Outcome|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
11361026|NCT02404545|EG000|Reported Event|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
11361027|NCT02404545|EG001|Reported Event|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
11361028|NCT02392377|BG000|Baseline|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
11361029|NCT02392377|BG001|Baseline|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
11361030|NCT02392377|BG002|Baseline|Total|Total of all reporting groups
11361031|NCT02392377|FG000|Participant Flow|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
11361032|NCT02392377|FG001|Participant Flow|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
11361033|NCT02392377|OG000|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
11361034|NCT02392377|OG001|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
11361035|NCT02392377|OG000|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"Experimental: Arm I (paclitaxel, carboplatin, radiation therapy, surgery) INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
11361036|NCT02392377|OG000|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION:Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
11361037|NCT02392377|EG000|Reported Event|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive paclitaxel IV over 60 minutes and carboplatin intravenously IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIATION THERAPY: Patients receive paclitaxel IVPB over 60 minutes and carboplatin IVPB over 30 minutes on days 8 and 22. Patients also undergo radiation therapy QD 5 days a week. Treatment continues for 5-6 weeks in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team.~Paclitaxel: Given IV or IVPB~Carboplatin: Given IV or IVPB~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo esophagectomy~Laboratory Biomarker Analysis: Correlative studies"
11361038|NCT02392377|EG001|Reported Event|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive oxaliplatin IV over 2-6 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIATION THERAPY: Patients receive oxaliplatin IV over 2-6 hours on days 1, 15, and 29 and fluorouracil IV continuously over 96 hours on days 1, 8, 15, 22, and 29. Patients also undergo radiation therapy QD 5 days a week for 5-6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team.~Oxaliplatin: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo esophagectomy~Laboratory Biomarker Analysis: Correlative studies"
11361039|NCT02399111|BG000|Baseline|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
11361040|NCT02399111|BG001|Baseline|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
11361041|NCT02399111|BG002|Baseline|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
11361042|NCT02399111|BG003|Baseline|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
11361043|NCT02399111|BG004|Baseline|Total|Total of all reporting groups
11361044|NCT02399111|FG000|Participant Flow|Not Obese:BMI<30; Standard Care|Not obese: BMI< 30; Standard Wound Care
11361045|NCT02399111|FG001|Participant Flow|Obese:BMI≥30; Standard Care|Obese: BMI ≥30; Standard Wound Care
11361046|NCT02399111|FG002|Participant Flow|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
11361047|NCT02399111|FG003|Participant Flow|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
11361048|NCT02399111|OG000|Outcome|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
11361049|NCT02399111|OG001|Outcome|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
11361050|NCT02399111|OG002|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
11361051|NCT02399111|OG003|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
11361052|NCT02399111|OG000|Outcome|Not Obese:BMI<30; Standard Care|Standard Wound Care
11361053|NCT02399111|OG001|Outcome|Obese:BMI≥30; Standard Care|Standard Wound Care
11361054|NCT02399111|EG000|Reported Event|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
11361055|NCT02399111|EG001|Reported Event|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
11361056|NCT02399111|EG002|Reported Event|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
11361057|NCT02399111|EG003|Reported Event|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
11361058|NCT02402036|BG000|Baseline|Regorafenib|"Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle~Regorafenib: Regorafenib orally for 21 days every 28 day cycle"
11361059|NCT02402036|FG000|Participant Flow|Regorafenib|"Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle~Regorafenib: Regorafenib orally for 21 days every 28 day cycle"
11361060|NCT02402036|OG000|Outcome|Regorafenib|"Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle~Regorafenib: Regorafenib orally for 21 days every 28 day cycle"
11361061|NCT02402036|EG000|Reported Event|Regorafenib|"Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle~Regorafenib: Regorafenib orally for 21 days every 28 day cycle"
11361062|NCT02394665|BG000|Baseline|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
11361063|NCT02394665|BG001|Baseline|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
11361064|NCT02394665|BG002|Baseline|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
11361065|NCT02394665|BG003|Baseline|Total|Total of all reporting groups
11361066|NCT02394665|FG000|Participant Flow|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
11361067|NCT02394665|FG001|Participant Flow|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
11361068|NCT02394665|FG002|Participant Flow|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
11361069|NCT02394665|OG000|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
11361070|NCT02394665|OG001|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
11361071|NCT02394665|OG002|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
11361072|NCT02394665|EG000|Reported Event|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
11361073|NCT02394665|EG001|Reported Event|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
11361074|NCT02394665|EG002|Reported Event|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
11361075|NCT02389712|BG000|Baseline|Lamotrigine|"Subjects on this arm will be randomized to Lamotrigine.~Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects."
11361076|NCT02389712|BG001|Baseline|Fluoxetine|"Subjects on this arm will be randomized to Fluoxetine.~Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg."
11361077|NCT02389712|BG002|Baseline|Total|Total of all reporting groups
11361078|NCT02389712|FG000|Participant Flow|Lamotrigine|"Subjects on this arm will be randomized to Lamotrigine.~Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects."
11361079|NCT02389712|FG001|Participant Flow|Fluoxetine|"Subjects on this arm will be randomized to Fluoxetine.~Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg."
11361080|NCT02389712|OG000|Outcome|Lamotrigine|"Subjects on this arm will be randomized to Lamotrigine.~Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects."
11361081|NCT02389712|OG001|Outcome|Fluoxetine|"Subjects on this arm will be randomized to Fluoxetine.~Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg."
11361082|NCT02389712|EG000|Reported Event|Lamotrigine|"Subjects on this arm will be randomized to Lamotrigine.~Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects."
11361083|NCT02389712|EG001|Reported Event|Fluoxetine|"Subjects on this arm will be randomized to Fluoxetine.~Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg."
11361084|NCT02390362|BG000|Baseline|Rituximab|"Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 & 3.~Rituximab: We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF"
11361085|NCT02390362|BG001|Baseline|Mycophenolate Mofetil (MMF)|"Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months~MMF: Subjects randomized to MMF, will continue MMF as scheduled by the investigator"
11361086|NCT02390362|BG002|Baseline|Total|Total of all reporting groups
11361087|NCT02390362|FG000|Participant Flow|Rituximab|"Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 & 3.~Rituximab: We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF"
11361088|NCT02390362|FG001|Participant Flow|Mycophenolate Mofetil (MMF)|"Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months~MMF: Subjects randomized to MMF, will continue MMF as scheduled by the investigator"
11361089|NCT02390362|OG000|Outcome|Rituximab|"Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 & 3.~Rituximab: We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF"
11361090|NCT02390362|OG001|Outcome|Mycophenolate Mofetil (MMF)|"Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months~MMF: Subjects randomized to MMF, will continue MMF as scheduled by the investigator"
11361091|NCT02390362|EG000|Reported Event|Rituximab|"Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 & 3.~Rituximab: We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF"
11361092|NCT02390362|EG001|Reported Event|Mycophenolate Mofetil (MMF)|"Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months~MMF: Subjects randomized to MMF, will continue MMF as scheduled by the investigator"
11361093|NCT02388776|BG000|Baseline|ROTEM|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
11361094|NCT02388776|FG000|Participant Flow|ROTEM|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
11361095|NCT02388776|OG000|Outcome|Active Arm|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
11361096|NCT02388776|OG000|Outcome|ROTEM|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
11361097|NCT02388776|EG000|Reported Event|Active Arm|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
11361098|NCT02383433|BG000|Baseline|Treatment (Regorafenib, Gemcitabine Hydrochloride)|"Patients receive regorafenib PO QD on days 1-21 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Regorafenib: Given PO~Gemcitabine Hydrochloride: Given IV"
11361099|NCT02383433|FG000|Participant Flow|Treatment (Regorafenib, Gemcitabine Hydrochloride)|"Patients receive regorafenib PO QD on days 1-21 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Regorafenib: Given PO~Gemcitabine Hydrochloride: Given IV"
11361100|NCT02383433|OG000|Outcome|Treatment (Regorafenib, Gemcitabine Hydrochloride)|"Patients receive regorafenib PO QD on days 1-21 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Regorafenib: Given PO~Gemcitabine Hydrochloride: Given IV"
11361101|NCT02383433|EG000|Reported Event|Treatment (Regorafenib, Gemcitabine Hydrochloride)|"Patients receive regorafenib PO QD on days 1-21 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Regorafenib: Given PO~Gemcitabine Hydrochloride: Given IV"
11361102|NCT02382588|BG000|Baseline|Gancyclovir Gel|"0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.~gancyclovir gel: 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier."
11361103|NCT02382588|BG001|Baseline|Hypromellose Gel|"0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.~Hypromellose gel: 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days."
11188301|NCT02111993|FG001|Participant Flow|Upper Limit of VulnerabilityTesting|"Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.~Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered."
11188302|NCT02111993|OG000|Outcome|Standard Defibrillation Testing|"Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.~Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes."
11188303|NCT02111993|OG001|Outcome|Upper Limit of VulnerabilityTesting|"Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.~Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered."
11188304|NCT02111993|OG001|Outcome|Upper Limit of VulnerabilityTesting (VF Induced)|"Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.~Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. VF was induced in a subset of the ULV patients, and a 25 J rescue shock was delivered."
11188305|NCT02111993|OG001|Outcome|Upper Limit of VulnerabilityTesting (No VF Induction)|"Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.~Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. VF was not induced in this subgroup with any of these shocks, and the ULV was considered to be 18J."
11188306|NCT02111993|EG000|Reported Event|Standard Defibrillation Testing|"Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.~Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes."
11188307|NCT02111993|EG001|Reported Event|Upper Limit of VulnerabilityTesting|"Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.~Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered."
11188308|NCT02112045|BG000|Baseline|Experimental: Granix and High Dose Melphalan (HDM)|"Granix on Day -7 through Day -2.~HDM intravenously (IV) on Day -2.~Autologous stem cell transplantation on Day 0"
11188309|NCT02112045|BG001|Baseline|Control: High Dose Melphalan (HDM)|HDM intravenously (IV) on Day -2.
11188310|NCT02112045|BG002|Baseline|Total|Total of all reporting groups
11188311|NCT02112045|FG000|Participant Flow|Experimental: Granix and High Dose Melphalan (HDM)|"Granix on Day -7 through Day -2.~HDM intravenously (IV) on Day -2.~Autologous stem cell transplantation on Day 0"
11188312|NCT02112045|FG001|Participant Flow|Control: High Dose Melphalan (HDM)|HDM intravenously (IV) on Day -2.
11188313|NCT02112045|OG000|Outcome|Experimental: Granix and High Dose Melphalan (HDM)|"Granix on Day -7 through Day -2.~HDM intravenously (IV) on Day -2.~Autologous stem cell transplantation on Day 0"
11188314|NCT02112045|OG001|Outcome|Control: High Dose Melphalan (HDM)|HDM intravenously (IV) on Day -2.
11188315|NCT02112045|EG000|Reported Event|Experimental: Granix and High Dose Melphalan (HDM)|"Granix on Day -7 through Day -2.~HDM intravenously (IV) on Day -2.~Autologous stem cell transplantation on Day 0"
11188316|NCT02112045|EG001|Reported Event|Control: High Dose Melphalan (HDM)|HDM intravenously (IV) on Day -2.
11188317|NCT02112370|BG000|Baseline|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
11361104|NCT02382588|BG002|Baseline|Total|Total of all reporting groups
11188318|NCT02112370|BG001|Baseline|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
11188319|NCT02112370|BG002|Baseline|Total|Total of all reporting groups
11188320|NCT02112370|FG000|Participant Flow|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
11239447|NCT02470806|EG001|Reported Event|tNPWT System|Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
11239448|NCT02470910|BG000|Baseline|Magnetic Resonance Imaging|"MRI examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy~Magnetic Resonance Imaging"
11188321|NCT02112370|FG001|Participant Flow|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
11188322|NCT02112370|OG000|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
11188323|NCT02112370|OG001|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
11188324|NCT02112370|EG000|Reported Event|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
11188325|NCT02112370|EG001|Reported Event|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
11188326|NCT02112448|BG000|Baseline|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188327|NCT02112448|BG001|Baseline|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188328|NCT02112448|BG002|Baseline|Total|Total of all reporting groups
11188329|NCT02112448|FG000|Participant Flow|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188330|NCT02112448|FG001|Participant Flow|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188331|NCT02112448|OG000|Outcome|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188332|NCT02112448|OG001|Outcome|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188333|NCT02112448|OG000|Outcome|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11239449|NCT02470910|FG000|Participant Flow|Magnetic Resonance Imaging|Magnetic Resonance Imaging (MRI) examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy.
11239450|NCT02470910|OG000|Outcome|MRI-based Planning|A radiation therapy plan was designed using MRI-defined prostate volume. Median volume of rectum receiving 70Gy or more was calculated from the dose-volume histogram.
11239451|NCT02470910|OG001|Outcome|CT-based Planning|A radiation therapy plan was designed using CT-defined prostate volume. Median volume of rectum receiving 70Gy or more was calculated from the dose-volume histogram.
11239452|NCT02470910|OG000|Outcome|MRI-based Planning|A radiation therapy plan was designed using MRI-defined prostate volume. Median volume of bladder receiving 70 Gy or more was calculated from the dose-volume histogram.
11239453|NCT02470910|OG001|Outcome|CT-based Planning|A radiation therapy plan was designed using CT-defined prostate volume. Median volume of bladder receiving 70 Gy or more was calculated from the dose-volume histogram.
11239454|NCT02470910|EG000|Reported Event|Magnetic Resonance Imaging|Magnetic Resonance Imaging (MRI) examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy.
11239455|NCT02470949|BG000|Baseline|All Study Participants|High Social Status Condition in Monopoly Game and Low Social Status Condition in Monopoly Game
11239456|NCT02470949|FG000|Participant Flow|Low Social Status, Then High Social Status|Low Social Status Condition in Monopoly Game during the first intervention period and High Social Status Condition in Monopoly Game during the second intervention period (after washout period).
11239457|NCT02470949|FG001|Participant Flow|High Social Status, Then Low Social Status|High Social Status Condition in Monopoly Game during the first intervention period and Low Social Status Condition in Monopoly Game during the second intervention period (after washout period).
11239458|NCT02470949|OG000|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
11239459|NCT02470949|OG001|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
11239460|NCT02470949|OG000|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
11239461|NCT02470949|OG001|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
11239462|NCT02470949|EG000|Reported Event|Low Social Status|"Low Social Status Condition in Monopoly Game.~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
11239463|NCT02470949|EG001|Reported Event|High Social Status|"High Social Status Condition in Monopoly Game~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
11239464|NCT02471014|BG000|Baseline|Obese Individuals|"Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.~Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.~Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.~Questionnaires: All participants will answer the following questionnaires:~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
11239465|NCT02471014|BG001|Baseline|Normal Individuals|"Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.~Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.~Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.~Questionnaires: All participants will answer the following questionnaires:~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
11239466|NCT02471014|BG002|Baseline|Total|Total of all reporting groups
11239467|NCT02471014|FG000|Participant Flow|Obese Individuals|"Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.~Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.~Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.~Questionnaires: All participants will answer the following questionnaires:~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
11239468|NCT02471014|FG001|Participant Flow|Normal Individuals|"Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.~Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.~Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.~Questionnaires: All participants will answer the following questionnaires:~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
11239469|NCT02471014|OG000|Outcome|Obese Individuals|"Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.~Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.~Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.~Questionnaires: All participants will answer the following questionnaires:~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
11239470|NCT02471014|OG001|Outcome|Normal Individuals|"Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.~Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.~Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.~Questionnaires: All participants will answer the following questionnaires:~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
11239471|NCT02471014|EG000|Reported Event|Obese Individuals|"Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.~Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.~Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.~Questionnaires: All participants will answer the following questionnaires:~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
11239472|NCT02471014|EG001|Reported Event|Normal Individuals|"Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.~Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.~Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.~Questionnaires: All participants will answer the following questionnaires:~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
11239473|NCT02471183|BG000|Baseline|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
11239474|NCT02471183|FG000|Participant Flow|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
11239475|NCT02471183|OG000|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
11239476|NCT02471183|EG000|Reported Event|Selexipag|All subjects who take at least one dose of selexipag. The mean duration of exposure to selexipag was 21.6 weeks
11239477|NCT02471313|BG000|Baseline|[18F] FMISO PET Scan|"Patients with primary hepatic malignancy who underwent [18F] FMISO PET Scan following transarterial chemoembolization (TACE) procedure~[18F] FMISO: [18F] Fluromisonidazole, 1 h-(3-[18F]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of [18F] FMISO PET imaging post TACE procedure."
11239478|NCT02471313|FG000|Participant Flow|[18F] FMISO PET Scan|"Patients with primary hepatic malignancy who underwent [18F] FMISO PET Scan following transarterial chemoembolization (TACE) procedure~[18F] FMISO: [18F] Fluromisonidazole, 1 h-(3-[18F]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of [18F] FMISO PET imaging post TACE procedure."
11361105|NCT02382588|FG000|Participant Flow|Gancyclovir Gel|"0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.~gancyclovir gel: 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier."
11361106|NCT02382588|FG001|Participant Flow|Hypromellose Gel|"0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.~Hypromellose gel: 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days."
11361107|NCT02382588|OG000|Outcome|Gancyclovir Gel|"0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.~gancyclovir gel: 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier."
11361108|NCT02382588|OG001|Outcome|Hypromellose Gel|"0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.~Hypromellose gel: 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days."
11361109|NCT02382588|EG000|Reported Event|Gancyclovir Gel|"0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.~gancyclovir gel: 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier."
11361110|NCT02382588|EG001|Reported Event|Hypromellose Gel|"0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.~Hypromellose gel: 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days."
11361111|NCT02381626|BG000|Baseline|Intervention Group|"During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. At the end of the initial two weeks, portable HEPA air purifiers (136) will be placed in the Intervention Group drivers' cars and the air monitoring and biological parameters will be repeated for another 2-week period, to determine changes in PM levels and physiological measurements as a result of this targeted intervention.~HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars~questionnaires~Log-book: PM and biological measurements~Urine sample: PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler"
11361112|NCT02381626|BG001|Baseline|Wait-list Control Group|"During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. The Wait-list Control Group drivers will not receive a HEPA air purifier at this time, but will also have the air monitoring and biological parameters repeated for another 2 weeks. At the end of the 1 month period of measurements for both groups of drivers, the Wait-list drivers will then receive a HEPA air purifier, so that they may also potentially benefit from the intervention being tested in this study, but no further measurements will be taken.~HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars~questionnaires~Log-book: PM and biological measurements~Urine sample: PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler"
11361113|NCT02381626|BG002|Baseline|Peer Non-driver|Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
11361114|NCT02381626|BG003|Baseline|Total|Total of all reporting groups
11361115|NCT02381626|FG000|Participant Flow|Intervention Group|"During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. At the end of the initial two weeks, portable HEPA air purifiers (136) will be placed in the Intervention Group drivers' cars and the air monitoring and biological parameters will be repeated for another 2-week period, to determine changes in PM levels and physiological measurements as a result of this targeted intervention.~HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars~questionnaires~Log-book: PM and biological measurements~Urine sample: PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler"
11361116|NCT02381626|FG001|Participant Flow|Wait-list Control Group|"During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. The Wait-list Control Group drivers will not receive a HEPA air purifier at this time, but will also have the air monitoring and biological parameters repeated for another 2 weeks. At the end of the 1 month period of measurements for both groups of drivers, the Wait-list drivers will then receive a HEPA air purifier, so that they may also potentially benefit from the intervention being tested in this study, but no further measurements will be taken.~HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars~questionnaires~Log-book: PM and biological measurements~Urine sample: PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler"
11361117|NCT02381626|FG002|Participant Flow|Peer Non-driver|Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
11361118|NCT02381626|OG000|Outcome|Intervention Group|"During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. At the end of the initial two weeks, portable HEPA air purifiers (136) will be placed in the Intervention Group drivers' cars and the air monitoring and biological parameters will be repeated for another 2-week period, to determine changes in PM levels and physiological measurements as a result of this targeted intervention.~HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars~questionnaires~Log-book: PM and biological measurements~Urine sample: PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler"
11361119|NCT02381626|OG001|Outcome|Wait-list Control Group|"During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. The Wait-list Control Group drivers will not receive a HEPA air purifier at this time, but will also have the air monitoring and biological parameters repeated for another 2 weeks. At the end of the 1 month period of measurements for both groups of drivers, the Wait-list drivers will then receive a HEPA air purifier, so that they may also potentially benefit from the intervention being tested in this study, but no further measurements will be taken.~HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars~questionnaires~Log-book: PM and biological measurements~Urine sample: PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler"
11361120|NCT02381626|OG002|Outcome|Peer Non-driver|Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
11361121|NCT02381626|EG000|Reported Event|Intervention Group|"During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. At the end of the initial two weeks, portable HEPA air purifiers (136) will be placed in the Intervention Group drivers' cars and the air monitoring and biological parameters will be repeated for another 2-week period, to determine changes in PM levels and physiological measurements as a result of this targeted intervention.~HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars~questionnaires~Log-book: PM and biological measurements~Urine sample: PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler"
11361122|NCT02381626|EG001|Reported Event|Wait-list Control Group|"During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. The Wait-list Control Group drivers will not receive a HEPA air purifier at this time, but will also have the air monitoring and biological parameters repeated for another 2 weeks. At the end of the 1 month period of measurements for both groups of drivers, the Wait-list drivers will then receive a HEPA air purifier, so that they may also potentially benefit from the intervention being tested in this study, but no further measurements will be taken.~HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars~questionnaires~Log-book: PM and biological measurements~Urine sample: PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler"
11361123|NCT02381626|EG002|Reported Event|Peer Non-driver|Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
11361124|NCT02379390|BG000|Baseline|Cabazitaxel|Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361125|NCT02379390|BG001|Baseline|Abiraterone Acetate or Enzalutamide|Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361126|NCT02379390|BG002|Baseline|Total|Total of all reporting groups
11361127|NCT02379390|FG000|Participant Flow|Cabazitaxel|Participants received Cabazitaxel 25 milligrams per meter square (mg/m^2), intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 milligrams (mg) orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361128|NCT02379390|FG001|Participant Flow|Abiraterone Acetate or Enzalutamide|Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361129|NCT02379390|OG000|Outcome|Cabazitaxel|Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361130|NCT02379390|OG001|Outcome|Abiraterone Acetate or Enzalutamide|Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361131|NCT02379390|OG000|Outcome|Cabazitaxel|Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361132|NCT02379390|EG000|Reported Event|Cabazitaxel|Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361133|NCT02379390|EG001|Reported Event|Enzalutamide or Abiraterone|Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361134|NCT02379390|EG002|Reported Event|Abiraterone|Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11188334|NCT02112448|OG001|Outcome|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188335|NCT02112448|EG000|Reported Event|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188336|NCT02112448|EG001|Reported Event|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
11188337|NCT02112838|BG000|Baseline|Fostamatinib 150 mg|"Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks~Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks"
11188338|NCT02112838|BG001|Baseline|Fostamatinib 100 mg|"Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks~Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks"
11188339|NCT02112838|BG002|Baseline|Placebo|"Placebo tablet twice daily by mouth, over the course of 24 weeks~Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks"
11188340|NCT02112838|BG003|Baseline|Total|Total of all reporting groups
11188341|NCT02112838|FG000|Participant Flow|Fostamatinib 150 mg|"Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks~Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks"
11188342|NCT02112838|FG001|Participant Flow|Fostamatinib 100 mg|"Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks~Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks"
11188343|NCT02112838|FG002|Participant Flow|Placebo|"Placebo tablet twice daily by mouth, over the course of 24 weeks~Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks"
11188344|NCT02112838|OG000|Outcome|Fostamatinib 150 mg|"Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks~Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks"
11188345|NCT02112838|OG001|Outcome|Fostamatinib 100 mg|"Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks~Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks"
11188346|NCT02112838|OG002|Outcome|Placebo|"Placebo tablet twice daily by mouth, over the course of 24 weeks~Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks"
11188347|NCT02112838|EG000|Reported Event|Fostamatinib 150 mg|"Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks~Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks"
11188348|NCT02112838|EG001|Reported Event|Fostamatinib 100 mg|"Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks~Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks"
11188349|NCT02112838|EG002|Reported Event|Placebo|"Placebo tablet twice daily by mouth, over the course of 24 weeks~Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks"
11188350|NCT02112877|BG000|Baseline|VICI Stent Implantation - Feasibility|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein~Veniti Vici™ Venous Stent System"
11188351|NCT02112877|BG001|Baseline|VICI Stent Implantation - Pivotal|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein~Veniti Vici™ Venous Stent System"
11188352|NCT02112877|BG002|Baseline|Total|Total of all reporting groups
11188353|NCT02112877|FG000|Participant Flow|VICI Stent Implantation - Feasibility|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein~Veniti Vici™ Venous Stent System"
11188354|NCT02112877|FG001|Participant Flow|VICI Stent Implantation - Pivotal|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein~Veniti Vici™ Venous Stent System"
11188355|NCT02112877|OG000|Outcome|VICI Stent Implantation - Feasibility|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein~Veniti Vici™ Venous Stent System"
11188356|NCT02112877|OG001|Outcome|VICI Stent Implantation - Pivotal|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein~Veniti Vici™ Venous Stent System"
11188357|NCT02112877|OG000|Outcome|VICI Stent Implantation - Feasibility|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System~Veniti Vici™ Venous Stent System"
11188358|NCT02112877|OG001|Outcome|VICI Stent Implantation - Pivotal|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System~Veniti Vici™ Venous Stent System"
11188359|NCT02112877|EG000|Reported Event|VICI Stent Implantation - Feasibility|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein~Veniti Vici™ Venous Stent System"
11361135|NCT02379390|EG003|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
11361136|NCT02373865|BG000|Baseline|Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose)|"Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)~Sitagliptin: Sitagliptin will be given in a daily dosage of 100 mg~Glimepiride-Placebo: Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg"
11361137|NCT02373865|BG001|Baseline|Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo|"Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo~Glimepiride: Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg~Sitagliptin-Placebo: Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg"
11361138|NCT02373865|BG002|Baseline|Total|Total of all reporting groups
11361139|NCT02373865|FG000|Participant Flow|Arm A|"Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)~Sitagliptin: Sitagliptin will be given in a daily dosage of 100 mg~Glimepiride-Placebo: Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg"
11361140|NCT02373865|FG001|Participant Flow|Arm B|"Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo~Glimepiride: Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg~Sitagliptin-Placebo: Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg"
11361141|NCT02373865|OG000|Outcome|Arm A|"Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)~Sitagliptin: Sitagliptin will be given in a daily dosage of 100 mg~Glimepiride-Placebo: Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg"
11188360|NCT02112877|EG001|Reported Event|VICI Stent Implantation - Pivotal|"Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein~Veniti Vici™ Venous Stent System"
11188361|NCT02112994|BG000|Baseline|Sebelipase Alfa|Pediatric and adult participants initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11188362|NCT02112994|FG000|Participant Flow|2-<4 Years|This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated intravenous (IV) treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg every week (qw) was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11361142|NCT02373865|OG001|Outcome|Arm B|"Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo~Glimepiride: Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg~Sitagliptin-Placebo: Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg"
11188363|NCT02112994|FG001|Participant Flow|4-18 Years|This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11361143|NCT02373865|EG000|Reported Event|Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose)|"Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)~Sitagliptin: Sitagliptin will be given in a daily dosage of 100 mg~Glimepiride-Placebo: Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg"
11361144|NCT02373865|EG001|Reported Event|Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo|"Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo~Glimepiride: Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg~Sitagliptin-Placebo: Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg"
11361145|NCT02365688|BG000|Baseline|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
11361146|NCT02365688|FG000|Participant Flow|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
11361147|NCT02365688|OG000|Outcome|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
11361148|NCT02365688|EG000|Reported Event|Pre-surgical Bolus|Pre-surgical bolus of 500 cc before incision rather than during incision for baseline hemodynamic data
11239479|NCT02471313|OG000|Outcome|Uptake of [18F] FMISO With PET Scan Imaging|"Patients with primary hepatic malignancy who underwent [18F] FMISO PET Scan following transarterial chemoembolization (TACE) procedure~[18F] FMISO: [18F] Fluromisonidazole, 1 h-(3-[18F]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of [18F] FMISO PET imaging post TACE procedure."
11239480|NCT02471313|EG000|Reported Event|[18F] FMISO PET Scan|Patients with primary hepatic malignancy are undergo [18F] FMISO PET Scan following transarterial chemoembolization (TACE) procedure.
11239481|NCT02471326|BG000|Baseline|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
11239482|NCT02471326|FG000|Participant Flow|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
11239483|NCT02471326|OG000|Outcome|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
11239484|NCT02471326|EG000|Reported Event|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
11239485|NCT02471404|BG000|Baseline|Dapagliflozin 10mg|Dapagliflozin 10mg + Metformin
11239486|NCT02471404|BG001|Baseline|Saxagliptin 5mg and Dapagliflozin 10mg|Saxagliptin 5mg and Dapagliflozin 10mg + Metformin
11239487|NCT02471404|BG002|Baseline|Glimepiride 1mg/2mg/4mg|Glimepiride 1mg/2mg/4mg + Metformin
11239488|NCT02471404|BG003|Baseline|Total|Total of all reporting groups
11239489|NCT02471404|FG000|Participant Flow|Dapagliflozin 10mg|Dapagliflozin 10mg + Metformin
11239490|NCT02471404|FG001|Participant Flow|Saxagliptin 5mg and Dapagliflozin 10mg|Saxagliptin 5mg and Dapagliflozin 10mg + Metformin
11239491|NCT02471404|FG002|Participant Flow|Glimepiride 1mg/2mg/4mg|Glimepiride 1mg/2mg/4mg + Metformin
11239492|NCT02471404|OG000|Outcome|Dapaglifozin 10mg|Dapaglifozin 10mg + Metformin
11239493|NCT02471404|OG001|Outcome|Saxagliptin 5mg and Dapagliflozin 10mg|Saxagliptin 5mg and Dapagliflozin 10mg + Metformin
11239494|NCT02471404|OG002|Outcome|Glimepiride 1mg/2mg/4mg|Glimepiride 1mg/2mg/4mg + Metformin
11239495|NCT02471404|EG000|Reported Event|Dapagliflozin 10mg|Dapagliflozin 10mg + Metformin
11239496|NCT02471404|EG001|Reported Event|Saxagliptin 5mg and Dapagliflozin 10mg|Saxagliptin 5mg and Dapagliflozin 10mg + Metformin
11239497|NCT02471404|EG002|Reported Event|Glimepiride 1mg/2mg/4mg|Glimepiride 1mg/2mg/4mg + Metformin
11239498|NCT02471521|BG000|Baseline|Neuromuscular Blocker Group|Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.
11239499|NCT02471521|BG001|Baseline|Non-neuromuscular Blocker Group|Facemask ventilation was performed without rocuronium administration.
11239500|NCT02471521|BG002|Baseline|Total|Total of all reporting groups
11239501|NCT02471521|FG000|Participant Flow|Neuromuscular Blocker Group|Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.
11239502|NCT02471521|FG001|Participant Flow|Non-neuromuscular Blocker Group|Facemask ventilation was performed without rocuronium administration.
11239503|NCT02471521|OG000|Outcome|Neuromuscular Blocker Group|Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.
11239504|NCT02471521|OG001|Outcome|Non-neuromuscular Blocker Group|Facemask ventilation was performed without rocuronium administration.
11239505|NCT02471521|EG000|Reported Event|Neuromuscular Blocker Group|Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.
11239506|NCT02471521|EG001|Reported Event|Non-neuromuscular Blocker Group|Facemask ventilation was performed without rocuronium administration.
11239507|NCT02471586|BG000|Baseline|Coronary PCI Guided by OCT|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation.~At the end of the procedure, a final OCT imaging run must be performed.~Coronary PCI guided by OCT: Imaging type"
11239508|NCT02471586|BG001|Baseline|Coronary PCI Guided by IVUS|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation.~At the end of the procedure, a final IVUS imaging run must be performed.~After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.~Coronary PCI guided by IVUS: Imaging type"
11239509|NCT02471586|BG002|Baseline|Coronary PCI Guided by Angiography|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with angiography guidance according to local standard practice.~At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.~Coronary PCI guided by Angiography: Imaging type"
11239510|NCT02471586|BG003|Baseline|Total|Total of all reporting groups
11239511|NCT02471586|FG000|Participant Flow|Coronary PCI Guided by OCT|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation.~At the end of the procedure, a final OCT imaging run must be performed.~Coronary PCI guided by OCT: Imaging type"
11239512|NCT02471586|FG001|Participant Flow|Coronary PCI Guided by IVUS|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation.~At the end of the procedure, a final IVUS imaging run must be performed.~After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.~Coronary PCI guided by IVUS: Imaging type"
11361149|NCT02361580|BG000|Baseline|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
11361150|NCT02361580|BG001|Baseline|No Diary|Control Group
11361151|NCT02361580|BG002|Baseline|Total|Total of all reporting groups
11361152|NCT02361580|FG000|Participant Flow|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
11361153|NCT02361580|FG001|Participant Flow|No Diary|Control Group
11361154|NCT02361580|OG000|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
11361155|NCT02361580|OG001|Outcome|No Diary|Control Group
11361156|NCT02361580|EG000|Reported Event|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
11361157|NCT02361580|EG001|Reported Event|No Diary|Control Group
11361158|NCT02369744|BG000|Baseline|Silodosin|"Subjects in the Silodosin Group will be given silodosin 8 mg tablets, one tablet to be taken PO each day for two weeks.~Silodosin: 8mg tablet, 1 tab PO daily for 2 weeks"
10962130|NCT00865020|OG000|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
10962131|NCT00865020|OG001|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
10962132|NCT00865020|EG000|Reported Event|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
10962133|NCT00865020|EG001|Reported Event|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
10962134|NCT00865046|BG000|Baseline|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
10962135|NCT00865046|BG001|Baseline|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
10962136|NCT00865046|BG002|Baseline|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
10962137|NCT00865046|BG003|Baseline|Total|Total of all reporting groups
11361159|NCT02369744|BG001|Baseline|Tamsulosin|"Subjects in the Tamsulosin Group will be given tamsulosin 0.4 mg tablets, one tablet to be taken PO each day for two weeks.~Tamsulosin: 0.4 mg Tab, 1 tab PO daily for 2 weeks"
11361160|NCT02369744|BG002|Baseline|Total|Total of all reporting groups
11361161|NCT02369744|FG000|Participant Flow|Silodosin|"Subjects in the Silodosin Group will be given silodosin 8 mg tablets, one tablet to be taken PO each day for two weeks.~Silodosin: 8mg tablet, 1 tab PO daily for 2 weeks"
11361162|NCT02369744|FG001|Participant Flow|Tamsulosin|"Subjects in the Tamsulosin Group will be given tamsulosin 0.4 mg tablets, one tablet to be taken PO each day for two weeks.~Tamsulosin: 0.4 mg Tab, 1 tab PO daily for 2 weeks"
11361163|NCT02369744|OG000|Outcome|Silodosin|"Subjects in the Silodosin Group will be given silodosin 8 mg tablets, one tablet to be taken PO each day for two weeks.~Silodosin: 8mg tablet, 1 tab PO daily for 2 weeks"
11361164|NCT02369744|OG001|Outcome|Tamsulosin|"Subjects in the Tamsulosin Group will be given tamsulosin 0.4 mg tablets, one tablet to be taken PO each day for two weeks.~Tamsulosin: 0.4 mg Tab, 1 tab PO daily for 2 weeks"
11361165|NCT02369744|EG000|Reported Event|Silodosin|"Subjects in the Silodosin Group will be given silodosin 8 mg tablets, one tablet to be taken PO each day for two weeks.~Silodosin: 8mg tablet, 1 tab PO daily for 2 weeks"
11361166|NCT02369744|EG001|Reported Event|Tamsulosin|"Subjects in the Tamsulosin Group will be given tamsulosin 0.4 mg tablets, one tablet to be taken PO each day for two weeks.~Tamsulosin: 0.4 mg Tab, 1 tab PO daily for 2 weeks"
11361167|NCT02379585|BG000|Baseline|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
11361168|NCT02379585|BG001|Baseline|Diagnosed With HER2 Positive Breast Cancer|will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
11361169|NCT02379585|BG002|Baseline|Total|Total of all reporting groups
11361170|NCT02379585|FG000|Participant Flow|Diagnosed With HER2 Negative Breast Cancer|"Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three-six weeks after completing the last cycle of paclitaxel.~Doxorubicin: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20~cyclophosphamide: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20~paclitaxel: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel ("
11361171|NCT02379585|FG001|Participant Flow|Diagnosed With HER2 Positive Breast Cancer|"will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year~docetaxel: For patients with HER2 positive breast cancer: docetaxel 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles be"
11361172|NCT02379585|OG000|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
11361173|NCT02379585|OG001|Outcome|Diagnosed With HER2 Positive Breast Cancer|will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
11361174|NCT02379585|OG000|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles.
11361175|NCT02379585|OG001|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days).
11361176|NCT02379585|OG001|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
11361177|NCT02379585|EG000|Reported Event|Diagnosed With HER2 Negative Breast Cancer|"Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.~0"
11361178|NCT02379585|EG001|Reported Event|Diagnosed With HER2 Positive Breast Cancer|will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
11361179|NCT02370888|BG000|Baseline|Dose Level 1|2.5 mg PO QOD Day 1-21 for 28 day cycle X 2 Enrolled 3 subjects
11361180|NCT02370888|BG001|Baseline|Dose Level 2|2.5 mg PO QD Day 1-21 for 28 day cycle X 2 cycles
11361181|NCT02370888|BG002|Baseline|Dose Level 3|5 mg PO QD Day 1-21 for 28 day cycle X 2 cycles
11361182|NCT02370888|BG003|Baseline|Dose Level 4|7.5 mg PO QD Day 1-21 for 28 day cycle X 2 cycles
11361183|NCT02370888|BG004|Baseline|Total|Total of all reporting groups
11361184|NCT02370888|FG000|Participant Flow|Dose Escalation of Lenalidomide|Participants in the Arm only received Dose Level 1: 2.5 mg PO QOD Day 1-21 for 28-day cycle X 2 cycles
11361185|NCT02370888|OG000|Outcome|Dose Level 1|Lenalidomide 2.5 mg by mouth every other day for twenty-one days of a 28 day cycle for 2 cycles.
11361186|NCT02370888|OG000|Outcome|Dose Level 1|Lenalidomide 2.5 mg by mouth every other day for twenty-one days of a 28 day cycle for two cycles.
11361187|NCT02370888|OG001|Outcome|Dose Level 2|Lenalidomide 2.5 mg by mouth daily for twenty-one days of a 28 day cycle for two cycles.
11361188|NCT02370888|OG002|Outcome|Dose Level 3|Lenalidomide 5 mg by mouth daily for twenty-one days of a 28 day cycle for 2 cycles.
11361189|NCT02370888|OG003|Outcome|Dose Level 4|Lenalidomide 7.5 mg by mouth daily for twenty-one days of a 28 day cycle for 2 cycles.
11361190|NCT02370888|EG000|Reported Event|Dose Level 1: 2.5 mg PO QOD Day 1-21 for 28 Day Cycle X 2|Subjects will be enrolled in cohorts of three (3). Lenalidomide will be administered for 21 consecutive days in a 28 day cycle X 2 cycles.
11361191|NCT02367170|BG000|Baseline|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
11361192|NCT02367170|BG001|Baseline|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
11361193|NCT02367170|BG002|Baseline|Total|Total of all reporting groups
11361194|NCT02367170|FG000|Participant Flow|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
11361195|NCT02367170|FG001|Participant Flow|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
11361196|NCT02367170|OG000|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
11361197|NCT02367170|OG001|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
11361198|NCT02367170|EG000|Reported Event|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
11361199|NCT02367170|EG001|Reported Event|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
11361200|NCT02376933|BG000|Baseline|Vertebroplasty With Radiotherapy|"Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.~Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.~Radiotherapy: Radiotherapy of metastatic lesions to the spine."
11361201|NCT02376933|FG000|Participant Flow|Vertebroplasty With Radiotherapy|"Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.~Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.~Radiotherapy: Radiotherapy of metastatic lesions to the spine."
11361202|NCT02376933|OG000|Outcome|Vertebroplasty With Radiotherapy|"Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.~Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.~Radiotherapy: Radiotherapy of metastatic lesions to the spine."
11361203|NCT02376933|EG000|Reported Event|Vertebroplasty With Radiotherapy|"Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.~Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.~Radiotherapy: Radiotherapy of metastatic lesions to the spine."
11361204|NCT02365233|BG000|Baseline|Thiazolidinedione|"(Pioglitazone, 15 mg/day)~Pioglitazone: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361205|NCT02365233|BG001|Baseline|Lantus Insulin|"0.35 U per kg body weight once daily~Lantus insulin: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361206|NCT02365233|BG002|Baseline|DPP4 Inhibitor|"Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day~DPP4 inhibitor: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361207|NCT02365233|BG003|Baseline|Total|Total of all reporting groups
11361208|NCT02365233|FG000|Participant Flow|Thiazolidinedione|"(Pioglitazone, 15 mg/day)~Pioglitazone: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11239513|NCT02471586|FG002|Participant Flow|Coronary PCI Guided by Angiography|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with angiography guidance according to local standard practice.~At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.~Coronary PCI guided by Angiography: Imaging type"
11239514|NCT02471586|OG000|Outcome|Coronary PCI Guided by OCT|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation.~At the end of the procedure, a final OCT imaging run must be performed.~Coronary PCI guided by OCT: Imaging type"
11239515|NCT02471586|OG001|Outcome|Coronary PCI Guided by IVUS|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation.~At the end of the procedure, a final IVUS imaging run must be performed.~After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.~Coronary PCI guided by IVUS: Imaging type"
11239516|NCT02471586|OG002|Outcome|Coronary PCI Guided by Angiography|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with angiography guidance according to local standard practice.~At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.~Coronary PCI guided by Angiography: Imaging type"
11239517|NCT02471586|OG001|Outcome|Coronary PCI Guided by IVUS|"Intervention =Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice.IVUS imaging is required pre and post stent implantation.~At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.~Coronary PCI guided by IVUS:Imaging type"
11239518|NCT02471586|OG002|Outcome|Coronary PCI Guided by Angiography|"Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice.~At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.~Coronary PCI guided by Angiography:Imaging type"
11239519|NCT02471586|EG000|Reported Event|Coronary PCI Guided by OCT|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation.~At the end of the procedure, a final OCT imaging run must be performed.~Coronary PCI guided by OCT: Imaging type"
11239520|NCT02471586|EG001|Reported Event|Coronary PCI Guided by IVUS|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation.~At the end of the procedure, a final IVUS imaging run must be performed.~After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.~Coronary PCI guided by IVUS: Imaging type"
11239521|NCT02471586|EG002|Reported Event|Coronary PCI Guided by Angiography|"Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with angiography guidance according to local standard practice.~At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.~Coronary PCI guided by Angiography: Imaging type"
11239522|NCT02471612|BG000|Baseline|Emergency Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the APACHE-2 Score & P-POSSUM Score
11239523|NCT02471612|FG000|Participant Flow|All Patients Who Underwent Emergency Exploratory Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the P-POSSUM Score APACHE-II
11239524|NCT02471612|OG000|Outcome|AUC Using APACHE II|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
11239525|NCT02471612|OG001|Outcome|AUC Using P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery.
11239526|NCT02471612|OG000|Outcome|Length of Stay|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were observed for their length of stay (LOS)
11239527|NCT02471612|OG000|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed ventilatory support postoperatively
11239528|NCT02471612|OG001|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed ventilatory support postoperatively
11239529|NCT02471612|OG000|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the need for inotropic support during their stay..
11239530|NCT02471612|OG001|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the need for inotropic support during their stay..
11239531|NCT02471612|OG000|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
11239532|NCT02471612|OG001|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
11361209|NCT02365233|FG001|Participant Flow|Lantus Insulin|"0.35 U per kg body weight once daily~Lantus insulin: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361210|NCT02365233|FG002|Participant Flow|DPP4 Inhibitor|"Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day~DPP4 inhibitor: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361211|NCT02365233|OG000|Outcome|Thiazolidinedione|"(Pioglitazone, 15 mg/day)~Pioglitazone: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361212|NCT02365233|OG001|Outcome|Lantus Insulin|"0.35 U per kg body weight once daily~Lantus insulin: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361213|NCT02365233|OG002|Outcome|DPP4 Inhibitor|"Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day~DPP4 inhibitor: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361214|NCT02365233|EG000|Reported Event|Thiazolidinedione|"(Pioglitazone, 15 mg/day)~Pioglitazone: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361215|NCT02365233|EG001|Reported Event|Lantus Insulin|"0.35 U per kg body weight once daily~Lantus insulin: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361216|NCT02365233|EG002|Reported Event|DPP4 Inhibitor|"Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day~DPP4 inhibitor: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone."
11361217|NCT02347943|BG000|Baseline|Balloon Sinus Dilation|Subjects who underwent a balloon sinus dilation procedure
11361218|NCT02347943|BG001|Baseline|Endoscopic Sinus Surgery (ESS)|Subjects who underwent a transnasal endoscopic sinus surgery
11361219|NCT02347943|BG002|Baseline|Hybrid|Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
11361220|NCT02347943|BG003|Baseline|Total|Total of all reporting groups
11361221|NCT02347943|FG000|Participant Flow|Balloon Sinus Dilation|Subjects who underwent a balloon sinus dilation procedure
11361222|NCT02347943|FG001|Participant Flow|Endoscopic Sinus Surgery (ESS)|Subjects who underwent a transnasal endoscopic sinus surgery
11361223|NCT02347943|FG002|Participant Flow|Hybrid|Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
11361224|NCT02347943|OG000|Outcome|Balloon Sinus Dilation|Subjects who underwent a balloon sinus dilation procedure
11361225|NCT02347943|OG001|Outcome|Endoscopic Sinus Surgery|Subjects who underwent a transnasal endoscopic sinus surgery
11361226|NCT02347943|OG002|Outcome|Hybrid|Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
11361227|NCT02347943|EG000|Reported Event|Balloon Sinus Dilation (BSD)|Subjects who underwent a balloon sinus dilation procedure
11361228|NCT02347943|EG001|Reported Event|Endoscopic Sinus Surgery (ESS)|Subjects who underwent a transnasal endoscopic sinus surgery
11361229|NCT02347943|EG002|Reported Event|Hybrid|Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
11361230|NCT02365207|BG000|Baseline|BCG Treatment of Invasive Bladder Cancer|"Invasive bladder cancer treated with 3-6 weeks of intravesical BCG~BCG strain of Mycobacterium bovis: Invasive bladder cancer treated with 3-6 weeks of intravesical BCG"
11361231|NCT02365207|FG000|Participant Flow|BCG Treatment of Invasive Bladder Cancer|"Invasive bladder cancer treated with 3-6 weeks of intravesical BCG~BCG strain of Mycobacterium bovis: Invasive bladder cancer treated with 3-6 weeks of intravesical BCG"
11361232|NCT02365207|OG000|Outcome|BCG Treatment of Invasive Bladder Cancer|"Invasive bladder cancer treated with 3-6 weeks of intravesical BCG~BCG strain of Mycobacterium bovis: Invasive bladder cancer treated with 3-6 weeks of intravesical BCG"
11361233|NCT02365207|EG000|Reported Event|BCG Treatment of Invasive Bladder Cancer|"Invasive bladder cancer treated with 3-6 weeks of intravesical BCG~BCG strain of Mycobacterium bovis: Invasive bladder cancer treated with 3-6 weeks of intravesical BCG"
11361234|NCT02360111|BG000|Baseline|Post Transplant Cyclophosphamide|"Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.~Cyclophosphamide"
11361235|NCT02360111|FG000|Participant Flow|Post Transplant Cyclophosphamide|"Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.~Cyclophosphamide"
11361236|NCT02360111|OG000|Outcome|Post Transplant Cyclophosphamide|"Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.~Cyclophosphamide"
11361237|NCT02360111|EG000|Reported Event|Post Transplant Cyclophosphamide|"Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.~Cyclophosphamide"
11239533|NCT02471612|OG000|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the Acute Kidney Injury
11239534|NCT02471612|OG001|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the Acute Kidney Injury
11239535|NCT02471612|OG000|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed re-exploration during the post-operative period.
11239536|NCT02471612|OG001|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed re-exploration during the post-operative period.
11239537|NCT02471612|EG000|Reported Event|APACHE-2 Scoring|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
11239538|NCT02471612|EG001|Reported Event|P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery
11239539|NCT02471651|BG000|Baseline|Implant|"Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.~Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone)."
11239540|NCT02471651|BG001|Baseline|Intravitreal Anti-VEGF Injection|"Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.~Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept."
11239541|NCT02471651|BG002|Baseline|Total|Total of all reporting groups
11239542|NCT02471651|FG000|Participant Flow|Implant|"Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.~Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone)."
11239543|NCT02471651|FG001|Participant Flow|Intravitreal Anti-VEGF Injection|"Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.~Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept."
11239544|NCT02471651|OG000|Outcome|Implant|"Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.~Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone)."
11239545|NCT02471651|OG001|Outcome|Intravitreal Anti-VEGF Injection|"Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.~Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept."
11361238|NCT02353468|BG000|Baseline|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
11361239|NCT02353468|FG000|Participant Flow|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
11361240|NCT02353468|OG000|Outcome|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
11361241|NCT02353468|EG000|Reported Event|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
11361242|NCT02360059|BG000|Baseline|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
11361243|NCT02360059|BG001|Baseline|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
11361244|NCT02360059|BG002|Baseline|Total|Total of all reporting groups
11361245|NCT02360059|FG000|Participant Flow|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
11361246|NCT02360059|FG001|Participant Flow|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
11361247|NCT02360059|OG000|Outcome|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
11361248|NCT02360059|OG001|Outcome|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
11361249|NCT02360059|EG000|Reported Event|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
11361250|NCT02360059|EG001|Reported Event|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
11361251|NCT02350777|BG000|Baseline|No Active Infection and/or Organ Compromise or GVHD.|This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
11361252|NCT02350777|BG001|Baseline|Active Infection, Active or Controlled GVHD &/or Organ Compro|This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
11361253|NCT02350777|BG002|Baseline|Total|Total of all reporting groups
11361254|NCT02350777|FG000|Participant Flow|No Active Infection and/or Organ Compromise or GVHD.|This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
11361255|NCT02350777|FG001|Participant Flow|Active Infection, Active or Controlled GVHD &/or Organ Compro|This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
11361256|NCT02350777|OG000|Outcome|No Active Infection and/or Organ Compromise or GVHD.|This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
11361257|NCT02350777|OG001|Outcome|Active Infection, Active or Controlled GVHD &/or Organ Compro|This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
11361258|NCT02350777|EG000|Reported Event|No Active Infection and/or Organ Compromise or GVHD.|This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
11361259|NCT02350777|EG001|Reported Event|Active Infection, Active or Controlled GVHD &/or Organ Compro|This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
11361260|NCT02345460|BG000|Baseline|Treatment (FOLFIRINOX)|"Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Irinotecan Hydrochloride: Given IV~Oxaliplatin: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11361261|NCT02345460|FG000|Participant Flow|Treatment (FOLFIRINOX)|"Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Irinotecan Hydrochloride: Given IV~Oxaliplatin: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11361262|NCT02345460|OG000|Outcome|Treatment (FOLFIRINOX)|"Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Irinotecan Hydrochloride: Given IV~Oxaliplatin: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11361263|NCT02345460|EG000|Reported Event|Treatment (FOLFIRINOX)|"Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Irinotecan Hydrochloride: Given IV~Oxaliplatin: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11376252|NCT01038778|OG000|Outcome|Treatment (Entinostat, Aldesleukin)|"Patients receive entinostat PO every 2 weeks beginning on day -14 and high-dose aldesleukin IV every 8 hours on days 1-5 and 15-19. Cycles repeat every 84 days* in the absence of disease progression or unacceptable toxicity.~NOTE: *Patients with evidence of tumor shrinkage may receive up to 3 cycles of high-dose aldesleukin therapy. Patients with stable disease by RECIST version 1.0 criteria, but without evidence of tumor shrinkage after two cycles will receive only entinostat until disease progression is documented.~Aldesleukin: Given IV~Computed Tomography: Undergo FDG-PET/CT~Entinostat: Given PO~Fludeoxyglucose F-18: Undergo FDG-PET/CT~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Positron Emission Tomography: Undergo FDG-PET/CT"
11376253|NCT01038778|EG000|Reported Event|Dose Level 1|Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11376254|NCT01038778|EG001|Reported Event|Dose Level 2|Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
11376255|NCT00980538|BG000|Baseline|Etravirine|Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research & Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than [<] 20 kilograms [kg]; ETR 125 mg bid for weight 20 to <25 kg; ETR 150 mg bid for weight 25 to <30 kg; and 200 mg bid for weight greater than or equal to [>=] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
11376256|NCT00980538|FG000|Participant Flow|Etravirine|Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research & Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than [<] 20 kilograms [kg]; ETR 125 mg bid for weight 20 to <25 kg; ETR 150 mg bid for weight 25 to <30 kg; and 200 mg bid for weight greater than or equal to [>=] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
11376257|NCT00980538|OG000|Outcome|Etravirine|Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research & Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than [<] 20 kilograms [kg]; ETR 125 mg bid for weight 20 to <25 kg; ETR 150 mg bid for weight 25 to <30 kg; and 200 mg bid for weight greater than or equal to [>=] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
11361264|NCT02346877|BG000|Baseline|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
11361265|NCT02346877|BG001|Baseline|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
11361266|NCT02346877|BG002|Baseline|Total|Total of all reporting groups
11361267|NCT02346877|FG000|Participant Flow|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
11361268|NCT02346877|FG001|Participant Flow|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
11361269|NCT02346877|OG000|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
11361270|NCT02346877|OG001|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
11361271|NCT02346877|EG000|Reported Event|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
11361272|NCT02346877|EG001|Reported Event|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
11361273|NCT02351063|BG000|Baseline|Daily BNP|"Subjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff. The subject's's physician and medical staff will be required to evaluate the data and determine if a change in HF treatment is advisable. All changes of heart failure medications are at the discretion of the treating physician and medical staff of the institution.~Changes of heart failure medications: Changes in dosage of existing medications or introduction of new medications to improve heart failure condition."
11361274|NCT02351063|FG000|Participant Flow|Daily BNP|"Subjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff. The subject's's physician and medical staff will be required to evaluate the data and determine if a change in HF treatment is advisable. All changes of heart failure medications are at the discretion of the treating physician and medical staff of the institution.~Changes of heart failure medications: Changes in dosage of existing medications or introduction of new medications to improve heart failure condition."
11361275|NCT02351063|OG000|Outcome|All Subjects|One subject enrolled but no data collected. Study terminated by sponsor.
11361276|NCT02351063|EG000|Reported Event|All Subjects|One subject enrolled but no data collected. Study terminated by sponsor.
11361277|NCT02345772|BG000|Baseline|Treatment Protocol|Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
11361278|NCT02345772|FG000|Participant Flow|Treatment Protocol|"Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.~fulvestrant 500 mg: Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.~Docetaxel (T) 75 mg/m2 (Taxotere): Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.~Trastuzumab (H, 8mg/kg: Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle,"
11377048|NCT00346164|FG003|Participant Flow|Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
11361279|NCT02345772|OG000|Outcome|Treatment Protocol|"Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.~fulvestrant 500 mg: Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.~Docetaxel (T) 75 mg/m2 (Taxotere): Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.~Trastuzumab (H, 8mg/kg: Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle,"
11361280|NCT02345772|EG000|Reported Event|Treatment Protocol|Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
11361281|NCT02340728|BG000|Baseline|ERCP With SEMS Plus Radiofrequency Ablation|"Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm.~ERCP with SEMS plus radiofrequency ablation"
11361282|NCT02340728|BG001|Baseline|ERCP With SEMS Alone (Standard of Care)|"Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period.~ERCP with SEMS alone (standard of care)"
11361283|NCT02340728|BG002|Baseline|Total|Total of all reporting groups
11361284|NCT02340728|FG000|Participant Flow|ERCP With SEMS Plus Radiofrequency Ablation|"Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm.~ERCP with SEMS plus radiofrequency ablation"
11361285|NCT02340728|FG001|Participant Flow|ERCP With SEMS Alone (Standard of Care)|"Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period.~ERCP with SEMS alone (standard of care)"
11361286|NCT02340728|OG000|Outcome|ERCP With SEMS Plus Radiofrequency Ablation|"Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm.~ERCP with SEMS plus radiofrequency ablation"
11361287|NCT02340728|OG001|Outcome|ERCP With SEMS Alone (Standard of Care)|"Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period.~ERCP with SEMS alone (standard of care)"
11361288|NCT02340728|EG000|Reported Event|ERCP With SEMS Plus Radiofrequency Ablation|"Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm.~ERCP with SEMS plus radiofrequency ablation"
11361289|NCT02340728|EG001|Reported Event|ERCP With SEMS Alone (Standard of Care)|"Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period.~ERCP with SEMS alone (standard of care)"
11361290|NCT02353572|BG000|Baseline|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
11361291|NCT02353572|FG000|Participant Flow|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
11361292|NCT02353572|OG000|Outcome|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
11361293|NCT02353572|EG000|Reported Event|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
11361294|NCT02345369|BG000|Baseline|Locked Set Screw|"In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw with locking of the set screw.~Locked Set Screw: Fixation of hip fracture with intramedullary hip screw with locking of the set screw"
11361295|NCT02345369|BG001|Baseline|Unlocked Set Screw|"In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw without locking of the set screw.~Unlocked Set Screw: Fixation of hip fracture with intramedullary hip screw without locking of the set screw"
11361296|NCT02345369|BG002|Baseline|Total|Total of all reporting groups
11361297|NCT02345369|FG000|Participant Flow|Locked Set Screw|"In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw with locking of the set screw.~Locked Set Screw: Fixation of hip fracture with intramedullary hip screw with locking of the set screw"
11361298|NCT02345369|FG001|Participant Flow|Unlocked Set Screw|"In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw without locking of the set screw.~Unlocked Set Screw: Fixation of hip fracture with intramedullary hip screw without locking of the set screw"
11361299|NCT02345369|OG000|Outcome|Locked Set Screw|"In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw with locking of the set screw.~Locked Set Screw: Fixation of hip fracture with intramedullary hip screw with locking of the set screw"
11361300|NCT02345369|OG001|Outcome|Unlocked Set Screw|"In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw without locking of the set screw.~Unlocked Set Screw: Fixation of hip fracture with intramedullary hip screw without locking of the set screw"
11361301|NCT02345369|EG000|Reported Event|Locked Set Screw|"In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw with locking of the set screw.~Locked Set Screw: Fixation of hip fracture with intramedullary hip screw with locking of the set screw"
11361302|NCT02345369|EG001|Reported Event|Unlocked Set Screw|"In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw without locking of the set screw.~Unlocked Set Screw: Fixation of hip fracture with intramedullary hip screw without locking of the set screw"
11361303|NCT02343263|BG000|Baseline|Control|44 patients will be randomized to receive no topical treatment to their tonsillectomy (or adenotonsillectomy) wound bed as is the current standard of care at our institution. The wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis alone.
11361304|NCT02343263|BG001|Baseline|Fibrin Sealant Alone|"44 patients will be randomized to receive application of topical fibrin sealant to their tonsillectomy (or adenotonsillectomy) wound bed to assess the pain reduction benefits of fibrin sealant alone. Prior to application of fibrin sealant, the wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis.~Fibrin Sealant: Fibrin sealant will be applied to the wound bed topically as per product instructions."
11361305|NCT02343263|BG002|Baseline|Bupivacaine-infused Fibrin Sealant|"44 patients will be randomized to receive application of topical bupivacaine-infused fibrin sealant to their tonsillectomy (or adenotonsillectomy) wound bed to assess the pain reduction benefits of fibrin sealant alone. Prior to application of fibrin sealant, the wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis.~Bupivacaine: 1 milliliter (mL) of 0.75% Bupivacaine Hydrochloride will be infused into 4mL of fibrin sealant (diluting the Bupivacaine HCl to 0.15%). The bupivacaine-infused fibrin sealant will then be applied to the tonsillectomy (or adenotonsillectomy) wound bed."
11361306|NCT02343263|BG003|Baseline|Total|Total of all reporting groups
11361307|NCT02343263|FG000|Participant Flow|Control Arm|Control Arm did not receive any Fibrin sealant nor Bupivacaine
11361308|NCT02343263|FG001|Participant Flow|Fibrin Sealant Alone|Fibrin Sealant Alone- subjects received only fibrin sealant to tonsillar fossa
11361309|NCT02343263|FG002|Participant Flow|Bupivacaine-infused Fibrin Sealant|Bupivacaine-infused Fibrin Sealant was placed in tonsillar fossa of subjects
11361310|NCT02343263|OG000|Outcome|Control Arm|study terminated due to FDA requirement for a investigational new drug application requirement. Subjects did not receive Fibrin sealant nor Bupivacaine
11361311|NCT02343263|OG001|Outcome|Fibrin Sealant Alone|subjects received fibrin sealant to tonsillar fossa
11361312|NCT02343263|OG002|Outcome|Bupivacaine-infused Fibrin Sealant|subjects received Bupivacaine-infused Fibrin Sealant to tonsillar fossa
11361313|NCT02343263|OG000|Outcome|Control Arm|subjects did not receive fibrin sealant nor bupivacaine
11361314|NCT02343263|OG000|Outcome|Control Arm|Control Arm did not receive any Fibrin sealant nor Bupivacaine
11239546|NCT02471651|EG000|Reported Event|Implant|"Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.~Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone)."
11239547|NCT02471651|EG001|Reported Event|Intravitreal Anti-VEGF Injection|"Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.~Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept."
11239548|NCT02471716|BG000|Baseline|Phase 1 FPA008 Dose Escalation 1mg/kg|Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
11239549|NCT02471716|BG001|Baseline|Phase 1 FPA008 Dose Escalation 2mg/kg|Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
11239550|NCT02471716|BG002|Baseline|Phase 1 FPA008 Dose Escalation 4mg/kg|Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
11239551|NCT02471716|BG003|Baseline|Phase 2 FPA008 Dose Expansion Cohort 2A|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
11239552|NCT02471716|BG004|Baseline|Phase 2 FPA008 Dose Expansion Cohort 2B|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
11239553|NCT02471716|BG005|Baseline|Total|Total of all reporting groups
11239554|NCT02471716|FG000|Participant Flow|Phase 1 FPA008 Dose Escalation 1mg/kg|Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
11239555|NCT02471716|FG001|Participant Flow|Phase 1 FPA008 Dose Escalation 2mg/kg|Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
11239556|NCT02471716|FG002|Participant Flow|Phase 1 FPA008 Dose Escalation 4mg/kg|Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
11239557|NCT02471716|FG003|Participant Flow|Phase 2 FPA008 Dose Expansion Cohort 2A|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
11239558|NCT02471716|FG004|Participant Flow|Phase 2 FPA008 Dose Expansion Cohort 2B|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
11239559|NCT02471716|OG000|Outcome|Phase 1 FPA008 Dose Escalation 1mg/kg|Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
11239560|NCT02471716|OG001|Outcome|Phase 1 FPA008 Dose Escalation 2mg/kg|Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
11239561|NCT02471716|OG002|Outcome|Phase 1 FPA008 Dose Escalation 4mg/kg|Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
11239562|NCT02471716|OG000|Outcome|Phase 2 FPA008 Dose Expansion Cohort 2A|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
11239563|NCT02471716|OG001|Outcome|Phase 2 FPA008 Dose Expansion Cohort 2B|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
11239564|NCT02471716|OG003|Outcome|Phase 2 FPA008 Dose Expansion Cohort 2A|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
11239565|NCT02471716|OG004|Outcome|Phase 2 FPA008 Dose Expansion Cohort 2B|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
11239566|NCT02471716|EG000|Reported Event|Phase 1 FPA008 Dose Escalation 1mg/kg|Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
11239567|NCT02471716|EG001|Reported Event|Phase 1 FPA008 Dose Escalation 2mg/kg|Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
11239568|NCT02471716|EG002|Reported Event|Phase 1 FPA008 Dose Escalation 4mg/kg|Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
11239569|NCT02471716|EG003|Reported Event|Phase 2 FPA008 Dose Expansion Cohort 2A|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
11239570|NCT02471716|EG004|Reported Event|Phase 2 FPA008 Dose Expansion Cohort 2B|Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
11239571|NCT02471755|BG000|Baseline|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
11361315|NCT02343263|OG001|Outcome|Fibrin Sealant Alone|Fibrin Sealant Alone- subjects received only fibrin sealant to tonsillar fossa
11361316|NCT02343263|OG002|Outcome|Bupivacaine-infused Fibrin Sealant|Bupivacaine-infused Fibrin Sealant was placed in tonsillar fossa of subjects
11361317|NCT02343263|EG000|Reported Event|Control Arm|subjects did not receive Fibrin sealant nor bupivacaine
11239572|NCT02471755|BG001|Baseline|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
11239573|NCT02471755|BG002|Baseline|Total|Total of all reporting groups
11239574|NCT02471755|FG000|Participant Flow|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
11239575|NCT02471755|FG001|Participant Flow|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
11239576|NCT02471755|OG000|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
11239577|NCT02471755|OG001|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
11239578|NCT02471755|EG000|Reported Event|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
11239579|NCT02471755|EG001|Reported Event|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
11239580|NCT02472145|BG000|Baseline|Part A: Decitabine + JNJ-56022473|Participants received 1 dose of JNJ-56022473 (talacotuzumab) at 9 milligram per kilogram (mg/kg) as intravenous (IV) infusion on Day 1 of cycle 1. From cycle 2 onwards, participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
11239581|NCT02472145|BG001|Baseline|Part B: Decitabine (Alone)|Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
11239582|NCT02472145|BG002|Baseline|Part B: Decitabine + JNJ-56022473|Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
11239583|NCT02472145|BG003|Baseline|Total|Total of all reporting groups
11361318|NCT02343263|EG001|Reported Event|Fibrin Sealant Alone|subjects received fibrin sealant alone to the tonsillar fossa
11361319|NCT02343263|EG002|Reported Event|Bupivacaine-infused Fibrin Sealant|subjects received Bupivacaine-infused Fibrin Sealant to the tonsillar fossa
11239584|NCT02472145|FG000|Participant Flow|Part A: Decitabine + JNJ-56022473|Participants received 1 dose of JNJ-56022473 (talacotuzumab) at 9 milligram per kilogram (mg/kg) as intravenous (IV) infusion on Day 1 of cycle 1. From cycle 2 onwards, participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
11239585|NCT02472145|FG001|Participant Flow|Part B: Decitabine (Alone)|Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
11239586|NCT02472145|FG002|Participant Flow|Part B: Decitabine + JNJ-56022473|Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
11239587|NCT02472145|OG000|Outcome|Part B: Decitabine (Alone)|Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
11239588|NCT02472145|OG001|Outcome|Part B: Decitabine + JNJ-56022473|Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
11239589|NCT02472145|EG000|Reported Event|Part A: Decitabine + JNJ-56022473|Participants received 1 dose of JNJ-56022473 (talacotuzumab) at 9 milligram per kilogram (mg/kg) as intravenous (IV) infusion on Day 1 of cycle 1. From cycle 2 onwards, participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
11239590|NCT02472145|EG001|Reported Event|Part B: Decitabine (Alone)|Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
11239591|NCT02472145|EG002|Reported Event|Part B: Decitabine + JNJ-56022473|Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
11239592|NCT02472223|BG000|Baseline|Betadine 5%|One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.
11239593|NCT02472223|BG001|Baseline|Artificial Tears|One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
11239594|NCT02472223|BG002|Baseline|Total|Total of all reporting groups
11239595|NCT02472223|FG000|Participant Flow|Betadine 5%|One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.
11239596|NCT02472223|FG001|Participant Flow|Artificial Tears|One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
11239597|NCT02472223|OG000|Outcome|Betadine 5%|One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.
11239598|NCT02472223|OG001|Outcome|Artificial Tears|One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
11239599|NCT02472223|EG000|Reported Event|Betadine 5%|"One time in-office use (4-5 drops)~Betadine 5%: One-time, in-office administration of Betadine 5%.~Betadine 5% exposure to the ocular surface is limited to 2 minutes in-office administration, followed by saline lavage per labeling instructions."
11239600|NCT02472223|EG001|Reported Event|Artificial Tears|"Standard of Care~Artificial Tears: Standard of care"
11239601|NCT02472262|BG000|Baseline|Cow Pea Complementary Food|"A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Cow pea complementary food: A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239602|NCT02472262|BG001|Baseline|Common Bean|"A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Common bean: A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239603|NCT02472262|BG002|Baseline|Corn Soy Flour|"Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Corn soy flour: Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239604|NCT02472262|BG003|Baseline|Total|Total of all reporting groups
11239605|NCT02472262|FG000|Participant Flow|Cow Pea Complementary Food|"A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Cow pea complementary food: A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239606|NCT02472262|FG001|Participant Flow|Common Bean|"A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Common bean: A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239607|NCT02472262|FG002|Participant Flow|Corn Soy Flour|"Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Corn soy flour: Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11361320|NCT02343159|BG000|Baseline|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361321|NCT02343159|BG001|Baseline|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361322|NCT02343159|BG002|Baseline|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361323|NCT02343159|BG003|Baseline|Total|Total of all reporting groups
11361324|NCT02343159|FG000|Participant Flow|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361325|NCT02343159|FG001|Participant Flow|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361326|NCT02343159|FG002|Participant Flow|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361327|NCT02343159|OG000|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361328|NCT02343159|OG001|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361329|NCT02343159|OG001|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361330|NCT02343159|OG002|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361331|NCT02343159|EG000|Reported Event|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361332|NCT02343159|EG001|Reported Event|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361333|NCT02343159|EG002|Reported Event|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
11361334|NCT02341495|BG000|Baseline|Drug Treatment|"Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV~Deferasirox: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO~Cholecalciferol: Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO~Azacitidine: Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks"
11361335|NCT02341495|FG000|Participant Flow|Drug Treatment|"Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV~Deferasirox: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO~Cholecalciferol: Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO~Azacitidine: Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks"
11361336|NCT02341495|OG000|Outcome|Drug Treatment|"Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV~Deferasirox: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO~Cholecalciferol: Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO~Azacitidine: Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks"
11361337|NCT02341495|EG000|Reported Event|Drug Treatment|"Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV~Deferasirox: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO~Cholecalciferol: Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO~Azacitidine: Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks"
11361338|NCT02336425|BG000|Baseline|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
11361339|NCT02336425|BG001|Baseline|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
11361340|NCT02336425|BG002|Baseline|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
11361341|NCT02336425|BG003|Baseline|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
11361342|NCT02336425|BG004|Baseline|Total|Total of all reporting groups
11361343|NCT02336425|FG000|Participant Flow|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
10962138|NCT00865046|FG000|Participant Flow|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
11361344|NCT02336425|FG001|Participant Flow|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
11361345|NCT02336425|FG002|Participant Flow|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
11361346|NCT02336425|FG003|Participant Flow|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
11361347|NCT02336425|OG000|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
11361348|NCT02336425|OG001|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
11361349|NCT02336425|OG002|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
11361350|NCT02336425|OG003|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
11361351|NCT02336425|EG000|Reported Event|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
11361352|NCT02336425|EG001|Reported Event|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
11361353|NCT02336425|EG002|Reported Event|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
11361354|NCT02336425|EG003|Reported Event|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
11361355|NCT02336763|BG000|Baseline|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
11361356|NCT02336763|FG000|Participant Flow|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
11361357|NCT02336763|OG000|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
11361358|NCT02336763|EG000|Reported Event|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
11361359|NCT02320825|BG000|Baseline|High-dose Hypofractionated SRS (27 Gy in 3 Fractions)|"hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.~high-dose hypofractionated SRS~Quality of Life Measures"
11361360|NCT02320825|BG001|Baseline|Single-fraction SRS (24 Gy)|"single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.~single-fraction SRS~Quality of Life Measures"
11361361|NCT02320825|BG002|Baseline|Total|Total of all reporting groups
11361362|NCT02320825|FG000|Participant Flow|High-dose Hypofractionated SRS (27 Gy in 3 Fractions)|"hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.~high-dose hypofractionated SRS~Quality of Life Measures"
11361363|NCT02320825|FG001|Participant Flow|Single-fraction SRS (24 Gy)|"single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.~single-fraction SRS~Quality of Life Measures"
11361364|NCT02320825|OG000|Outcome|Single-fraction SRS (24 Gy)|"single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.~single-fraction SRS~Quality of Life Measures"
11361365|NCT02320825|OG001|Outcome|High-dose Hypofractionated SRS (27 Gy in 3 Fractions)|"hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.~high-dose hypofractionated SRS~Quality of Life Measures"
11361366|NCT02320825|EG000|Reported Event|High-dose Hypofractionated SRS (27 Gy in 3 Fractions)|"hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.~high-dose hypofractionated SRS~Quality of Life Measures"
11361367|NCT02320825|EG001|Reported Event|Single-fraction SRS (24 Gy)|"single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.~single-fraction SRS~Quality of Life Measures"
11361368|NCT02319005|BG000|Baseline|Revusiran|All patients who received at least 1 dose of revusiran
11361369|NCT02319005|BG001|Baseline|Placebo|All patients who received at least 1 dose of placebo
11361370|NCT02319005|BG002|Baseline|Total|Total of all reporting groups
11361371|NCT02319005|FG000|Participant Flow|Revusiran (ALN-TTRSC)|All patients who received at least 1 dose of revusiran
11361372|NCT02319005|FG001|Participant Flow|Placebo|All patients who received at least 1 dose of placebo
11361373|NCT02319005|OG000|Outcome|Revusiran|All patients who received at least 1 dose of revusiran
11361374|NCT02319005|OG001|Outcome|Placebo|All patients who received at least 1 dose of placebo
11361375|NCT02319005|EG000|Reported Event|Revusiran|All patients who received at least 1 dose of revusiran
11361376|NCT02319005|EG001|Reported Event|Placebo|All patients who received at least 1 dose of placebo
11361377|NCT02318901|BG000|Baseline|Arm 1|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days.~Pembrolizumab~Trastuzumab"
11361378|NCT02318901|BG001|Baseline|Arm 2|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days.~Pembrolizumab~ado-trastuzumab emtansine"
11361379|NCT02318901|BG002|Baseline|Arm 3|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days.~Pembrolizumab~Cetuximab"
11361380|NCT02318901|BG003|Baseline|Total|Total of all reporting groups
11361381|NCT02318901|FG000|Participant Flow|Arm 1|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days.~Pembrolizumab~Trastuzumab"
11361382|NCT02318901|FG001|Participant Flow|Arm 2|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days.~Pembrolizumab~ado-trastuzumab emtansine"
11239608|NCT02472262|OG000|Outcome|Cow Pea Complementary Food|"A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Cow pea complementary food: A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239609|NCT02472262|OG001|Outcome|Common Bean|"A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Common bean: A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239610|NCT02472262|OG002|Outcome|Corn Soy Flour|"Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Corn soy flour: Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239611|NCT02472262|EG000|Reported Event|Cow Pea Complementary Food|"A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Cow pea complementary food: A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239612|NCT02472262|EG001|Reported Event|Common Bean|"A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Common bean: A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239613|NCT02472262|EG002|Reported Event|Corn Soy Flour|"Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.~Corn soy flour: Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old."
11239614|NCT02472314|BG000|Baseline|Liposomal Bupivacaine A|"One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty~1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery"
11239615|NCT02472314|BG001|Baseline|CISB Control for A|"Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .~0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively"
11239616|NCT02472314|BG002|Baseline|Total|Total of all reporting groups
11239617|NCT02472314|FG000|Participant Flow|Liposomal Bupivacaine A|"One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty~1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery"
11239618|NCT02472314|FG001|Participant Flow|CISB Control for A|"Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .~0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively"
11239619|NCT02472314|OG000|Outcome|Liposomal Bupivacaine A|"One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty~1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery"
11239620|NCT02472314|OG001|Outcome|CISB Control for A|"Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .~0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively"
11361383|NCT02318901|FG002|Participant Flow|Arm 3|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days.~Pembrolizumab~Cetuximab"
11239621|NCT02472314|EG000|Reported Event|Liposomal Bupivacaine A|"One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty~1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery"
11239622|NCT02472314|EG001|Reported Event|CISB Control for A|"Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .~0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively"
11239623|NCT02472353|BG000|Baseline|Standard of Care|"Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.~Doxorubicin: Standard of care treatment with doxorubicin"
11239624|NCT02472353|BG001|Baseline|Metformin + Standard of Care|"Patients will receive metformin during their treatment with doxorubicin for their breast cancer.~Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.~Doxorubicin: Standard of care treatment with doxorubicin"
11239625|NCT02472353|BG002|Baseline|Total|Total of all reporting groups
11239626|NCT02472353|FG000|Participant Flow|Standard of Care|"Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.~Doxorubicin: Standard of care treatment with doxorubicin"
11239627|NCT02472353|FG001|Participant Flow|Metformin + Standard of Care|"Patients will receive metformin during their treatment with doxorubicin for their breast cancer.~Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.~Doxorubicin: Standard of care treatment with doxorubicin"
11239628|NCT02472353|OG000|Outcome|Standard of Care|"Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.~Doxorubicin: Standard of care treatment with doxorubicin"
11239629|NCT02472353|OG001|Outcome|Metformin + Standard of Care|"Patients will receive metformin during their treatment with doxorubicin for their breast cancer.~Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.~Doxorubicin: Standard of care treatment with doxorubicin"
11239630|NCT02472353|EG000|Reported Event|Standard of Care|"Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.~Doxorubicin: Standard of care treatment with doxorubicin"
11361384|NCT02318901|OG000|Outcome|Arm 1|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days.~Pembrolizumab~Trastuzumab"
11361385|NCT02318901|OG001|Outcome|Arm 2|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days.~Pembrolizumab~ado-trastuzumab emtansine"
11361386|NCT02318901|OG002|Outcome|Arm 3|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days.~Pembrolizumab~Cetuximab"
11361387|NCT02318901|EG000|Reported Event|Arm 1|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days.~Pembrolizumab~Trastuzumab"
11361388|NCT02318901|EG001|Reported Event|Arm 2|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days.~Pembrolizumab~ado-trastuzumab emtansine"
11361389|NCT02318901|EG002|Reported Event|Arm 3|"Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days.~Pembrolizumab~Cetuximab"
11361390|NCT02317276|BG000|Baseline|Treatment|"Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods.~Triamcinolone 0.1%: Topical ointment"
11361391|NCT02317276|FG000|Participant Flow|Treatment|"Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods.~Triamcinolone 0.1%: Topical ointment"
11361392|NCT02317276|OG000|Outcome|Treatment|"Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods.~Triamcinolone 0.1%: Topical ointment"
11361393|NCT02317276|EG000|Reported Event|Treatment|"Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods.~Triamcinolone 0.1%: Topical ointment"
11361394|NCT02307188|BG000|Baseline|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter."
11361395|NCT02307188|FG000|Participant Flow|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~Since enrollment began, a total of five (5) patients consented to enrollment in the study during their atrial fibrillation/tachycardia ablation procedures. The catheter (a new catheter was used for each patient) was used in the left atrium in one patient who met all inclusion criteria and did not have any exclusions."
11361396|NCT02307188|OG000|Outcome|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~Five (5) patients were enrolled. The catheters were used in the left atrium in one (1) patient. The remaining patients were excluded because of subtherapeutic ACT levels < 300 seconds (3 patients) or presence of prosthetic valve (1 patient).~Due to the paucity of information collected from the one patient for whom the catheter was used in the left atrium, the collected electrogram data were not analyzed further."
11361397|NCT02307188|EG000|Reported Event|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~No adverse events related to this catheter were noted."
11361398|NCT02308475|BG000|Baseline|Myocardial Stress CT Perfusion|"Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the dynamic shuttle mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium.~Somatom Force CT Scanner: Dynamic CT perfusion of the heart"
11361399|NCT02308475|FG000|Participant Flow|Myocardial Stress CT Perfusion|"Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the dynamic shuttle mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium.~Somatom Force CT Scanner: Dynamic CT perfusion of the heart"
11361400|NCT02308475|OG000|Outcome|Myocardial Stress CT Perfusion|"Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the dynamic shuttle mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium.~Somatom Force CT Scanner: Dynamic CT perfusion of the heart"
11361401|NCT02308475|EG000|Reported Event|Myocardial Stress CT Perfusion|"Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the dynamic shuttle mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium.~Somatom Force CT Scanner: Dynamic CT perfusion of the heart"
11361402|NCT02308735|BG000|Baseline|Control|"Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).~N/A - No intervention"
11361403|NCT02308735|BG001|Baseline|A1 IDM|"Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).~N/A - No intervention"
11361404|NCT02308735|BG002|Baseline|A2 IDM|"Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).~N/A - No intervention"
11361405|NCT02308735|BG003|Baseline|PGDM - IDM|"Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).~N/A - No intervention"
11361406|NCT02308735|BG004|Baseline|Total|Total of all reporting groups
11361407|NCT02308735|FG000|Participant Flow|Control|"Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).~N/A - No intervention"
11361408|NCT02308735|FG001|Participant Flow|A1 IDM|"Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).~N/A - No intervention"
11361409|NCT02308735|FG002|Participant Flow|A2 IDM|"Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).~N/A - No intervention"
11361410|NCT02308735|FG003|Participant Flow|PGDM - IDM|"Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).~N/A - No intervention"
11361411|NCT02308735|OG000|Outcome|Control|"Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).~N/A - No intervention"
11361412|NCT02308735|OG001|Outcome|A1 IDM|"Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).~N/A - No intervention"
11361413|NCT02308735|OG002|Outcome|A2 IDM|"Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).~N/A - No intervention"
10962139|NCT00865046|FG001|Participant Flow|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
10962140|NCT00865046|FG002|Participant Flow|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
11361414|NCT02308735|OG003|Outcome|PGDM - IDM|"Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).~N/A - No intervention"
11361415|NCT02308735|EG000|Reported Event|Control|"Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).~N/A - No intervention"
11361416|NCT02308735|EG001|Reported Event|A1 IDM|"Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).~N/A - No intervention"
11361417|NCT02308735|EG002|Reported Event|A2 IDM|"Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).~N/A - No intervention"
11361418|NCT02308735|EG003|Reported Event|PGDM - IDM|"Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).~N/A - No intervention"
11361419|NCT02299206|BG000|Baseline|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
10962141|NCT00865046|OG000|Outcome|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
11188364|NCT02112994|FG002|Participant Flow|>18 Years|This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11361420|NCT02299206|FG000|Participant Flow|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
11361421|NCT02299206|OG000|Outcome|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
11361422|NCT02299206|EG000|Reported Event|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.~Arms are combined for reporting of adverse events. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined."
11361423|NCT02302859|BG000|Baseline|Standard Treatment (ST)|Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.
11361424|NCT02302859|BG001|Baseline|Automated Treatment (AT)|Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.
11361425|NCT02302859|BG002|Baseline|Total|Total of all reporting groups
11361426|NCT02302859|FG000|Participant Flow|Standard Treatment (ST)|Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.
11188365|NCT02112994|OG000|Outcome|2-<4 Years|This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11361427|NCT02302859|FG001|Participant Flow|Automated Treatment (AT)|Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.
11188366|NCT02112994|OG001|Outcome|4-18 Years|This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11188367|NCT02112994|OG002|Outcome|>18 Years|This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11188368|NCT02112994|OG000|Outcome|Sebelipase Alfa|Pediatric and adult participants initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11188369|NCT02112994|OG000|Outcome|Pediatric Participants|Pediatric participants initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
11188370|NCT02112994|EG000|Reported Event|0.35 mg/kg QOW|This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 0.35 mg/kg qow.
11188371|NCT02112994|EG001|Reported Event|1.0 mg/kg QOW|This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qow.
11188372|NCT02112994|EG002|Reported Event|1.0 mg/kg QW|This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qw.
11188373|NCT02112994|EG003|Reported Event|3.0 mg/kg QOW|This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qow.
11188374|NCT02112994|EG004|Reported Event|3.0 mg/kg QW|This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qw.
11188375|NCT02113007|BG000|Baseline|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
11188376|NCT02113007|FG000|Participant Flow|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
11188377|NCT02113007|OG000|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
10962142|NCT00865046|OG001|Outcome|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
10962143|NCT00865046|OG002|Outcome|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
10962144|NCT00865046|EG000|Reported Event|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
10962145|NCT00865046|EG001|Reported Event|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
10962146|NCT00865046|EG002|Reported Event|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
10962147|NCT00865098|BG000|Baseline|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
10962148|NCT00865098|FG000|Participant Flow|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
10962149|NCT00865098|OG000|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
10962150|NCT00865098|EG000|Reported Event|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
10962151|NCT00865124|BG000|Baseline|Spironolactone (MR Blockade)|Spironolactone: 25 mg capsule daily for 6 months
10962152|NCT00865124|BG001|Baseline|Hydrochlorothiazide + Potassium|Hydrochlorothiazide + potassium: hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
10962153|NCT00865124|BG002|Baseline|Placebo Capsule|Placebo: Placebo capsule daily
10962154|NCT00865124|BG003|Baseline|Total|Total of all reporting groups
10962155|NCT00865124|FG000|Participant Flow|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
10962156|NCT00865124|FG001|Participant Flow|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily
10962157|NCT00865124|FG002|Participant Flow|Placebo|Placebo capsule daily
10962158|NCT00865124|OG000|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
10962159|NCT00865124|OG001|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
10962160|NCT00865124|OG002|Outcome|Placebo|Placebo capsule daily
10962161|NCT00865124|EG000|Reported Event|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
10962162|NCT00865124|EG001|Reported Event|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
10962163|NCT00865124|EG002|Reported Event|Placebo|Placebo capsule daily
10962164|NCT00865189|BG000|Baseline|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
11239631|NCT02472353|EG001|Reported Event|Metformin + Standard of Care|"Patients will receive metformin during their treatment with doxorubicin for their breast cancer.~Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.~Doxorubicin: Standard of care treatment with doxorubicin"
10962165|NCT00865189|BG001|Baseline|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
10962166|NCT00865189|BG002|Baseline|Total|Total of all reporting groups
10962167|NCT00865189|FG000|Participant Flow|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.
10962168|NCT00865189|FG001|Participant Flow|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
10962169|NCT00865189|OG000|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
11361428|NCT02302859|OG000|Outcome|Standard Treatment (ST)|Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.
11239632|NCT02472366|BG000|Baseline|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
11239633|NCT02472366|BG001|Baseline|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
11239634|NCT02472366|BG002|Baseline|Total|Total of all reporting groups
11239635|NCT02472366|FG000|Participant Flow|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
11239636|NCT02472366|FG001|Participant Flow|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
11239637|NCT02472366|OG000|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
11239638|NCT02472366|OG001|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
11239639|NCT02472366|EG000|Reported Event|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
11239640|NCT02472366|EG001|Reported Event|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
11239641|NCT02472405|BG000|Baseline|595nm PDL - 595/1064nm Multiplex - Control|A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
11239642|NCT02472405|FG000|Participant Flow|595nm PDL - 595/1064nm Multiplex - Control|A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
11239643|NCT02472405|OG000|Outcome|595nm PDL|"One third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.~595nm PDL: One third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week)."
11239644|NCT02472405|OG001|Outcome|595/1064nm Multiplex Laser|"One third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.~595/1064nm Multiplex Laser: The multiplex cynergy laser was used for this study. A third of the scar was solely be treated with the 595nm PDL."
11239645|NCT02472405|OG002|Outcome|Control|One third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
11239646|NCT02472405|EG000|Reported Event|595nm PDL - 595/1064nm Multiplex Laser - Control|"A third of each participant's scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). The remaining third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.~595/1064nm Multiplex Laser: The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL."
11239647|NCT02472457|BG000|Baseline|Free Diet|"No dietary restrictions~Free Diet: This diet contains no restrictions."
10962170|NCT00865189|OG001|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
10962171|NCT00865189|EG000|Reported Event|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
11361429|NCT02302859|OG001|Outcome|Automated Treatment (AT)|Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.
11361430|NCT02302859|EG000|Reported Event|Standard Treatment (ST)|Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.
11361431|NCT02302859|EG001|Reported Event|Automated Treatment (AT)|Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.
11361432|NCT02299934|BG000|Baseline|Subjects Who Fulfill the Criteria for Living Liver Donation|"Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).~Magnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.~Compurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature."
11188378|NCT02113007|EG000|Reported Event|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
11188379|NCT02113124|BG000|Baseline|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
11188380|NCT02113124|BG001|Baseline|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
11188381|NCT02113124|BG002|Baseline|Total|Total of all reporting groups
11188382|NCT02113124|FG000|Participant Flow|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
11188383|NCT02113124|FG001|Participant Flow|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
11188384|NCT02113124|OG000|Outcome|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
11361433|NCT02299934|FG000|Participant Flow|Subjects Who Fulfill the Criteria for Living Liver Donation|"Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).~Magnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.~Compurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature."
11361434|NCT02299934|OG000|Outcome|Subjects Who Fulfill the Criteria for Living Liver Donation|"Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).~Magnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.~Compurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature."
11361435|NCT02299934|EG000|Reported Event|Subjects Who Fulfill the Criteria for Living Liver Donation|"Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).~Magnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.~Compurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature."
11188385|NCT02113124|OG001|Outcome|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
11188386|NCT02113124|EG000|Reported Event|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
11188387|NCT02113124|EG001|Reported Event|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
11188388|NCT02113189|BG000|Baseline|Walking Program With Ankle Brace|"This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.~Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on."
11188389|NCT02113189|BG001|Baseline|Individualized Walking Program|"This group will receive a customized walking program.~Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking"
11188390|NCT02113189|BG002|Baseline|Walking Program With Custom Braces|"This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.~Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on."
11188391|NCT02113189|BG003|Baseline|Total|Total of all reporting groups
10962172|NCT00865189|EG001|Reported Event|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
10962173|NCT00865202|BG000|Baseline|L-tryptophan|L-tryptophan 1 gm enterally TID starting the evening of the operation
10962174|NCT00865202|BG001|Baseline|Placebo|similar appearing placebo
10962175|NCT00865202|BG002|Baseline|Total|Total of all reporting groups
10962176|NCT00865202|FG000|Participant Flow|Study Drug|L-tryptophan 1 gm enterally TID starting the evening of the operation
10962177|NCT00865202|FG001|Participant Flow|Placebo|Similar appearing placebo
10962178|NCT00865202|OG000|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
10962179|NCT00865202|OG001|Outcome|Placebo|similar appearing placebo
10962180|NCT00865202|OG001|Outcome|Placebo|Similar appearing placebo
10962181|NCT00865202|EG000|Reported Event|Study Drug|L-tryptophan 1 gm enterally TID starting the evening of the operation
10962182|NCT00865202|EG001|Reported Event|Placebo|Similar appearing placebo
10962183|NCT00865280|BG000|Baseline|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 24 hours (q24h) for up to 4 to 7 days, then received a 300 mg oral administration q24h. The total treatment duration was up to 14 days. To maintain the blind, participants received an omadacycline infusion alternating with a placebo infusion q12h.
10962184|NCT00865280|BG001|Baseline|Linezolid|Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections.
10962185|NCT00865280|BG002|Baseline|Total|Total of all reporting groups
10962186|NCT00865280|FG000|Participant Flow|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 24 hours (q24h) for up to 4 to 7 days, then received a 300 mg oral administration q24h. The total treatment duration was up to 14 days. To maintain the blind, participants received an omadacycline infusion alternating with a placebo infusion q12h.
10962187|NCT00865280|FG001|Participant Flow|Linezolid|Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections.
10962188|NCT00865280|OG000|Outcome|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 24 hours (q24h) for up to 4 to 7 days, then received a 300 mg oral administration q24h. The total treatment duration was up to 14 days. To maintain the blind, participants received an omadacycline infusion alternating with a placebo infusion q12h.
10962189|NCT00865280|OG001|Outcome|Linezolid|Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections.
10962190|NCT00865280|EG000|Reported Event|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 24 hours (q24h) for up to 4 to 7 days, then received a 300 mg oral administration q24h. The total treatment duration was up to 14 days. To maintain the blind, participants received an omadacycline infusion alternating with a placebo infusion q12h.
10962191|NCT00865280|EG001|Reported Event|Linezolid|Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections.
10962192|NCT00865306|BG000|Baseline|Active CBT|
10962193|NCT00865306|BG001|Baseline|No Intervention (Wait-list Controls)|
10962194|NCT00865306|BG002|Baseline|Total|Total of all reporting groups
10962195|NCT00865306|FG000|Participant Flow|Active CBT|This was parent-child CBT, administered to families individually over 6 months, and including six 1-hour parent-only sessions, followed by 8-13 1-hour child-parent sessions, and one final 1-hour parent-only session.
10962196|NCT00865306|FG001|Participant Flow|No Intervention (Wait-list Controls)|This was a 6-month wait-list control condition in which children received no intervention. After participating in the control condition, families who wanted it were offered the opportunity to receive the CBT intervention.
10962197|NCT00865306|OG000|Outcome|Active CBT|
10962198|NCT00865306|OG001|Outcome|No Intervention (Wait-list Controls)|
10962199|NCT00865306|EG000|Reported Event|Active CBT|
10962200|NCT00865306|EG001|Reported Event|No Intervention (Wait-list Controls)|
10962201|NCT00865345|BG000|Baseline|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
10962202|NCT00865345|FG000|Participant Flow|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
10962203|NCT00865345|OG000|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
10962204|NCT00865345|EG000|Reported Event|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
10962205|NCT00865566|BG000|Baseline|Vaccine|"Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid~Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid"
11188392|NCT02113189|FG000|Participant Flow|Walking Program With Ankle Brace|"This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.~Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on."
11361436|NCT02297230|BG000|Baseline|Arm 1 Capecitabine and RT|Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).
11361437|NCT02297230|BG001|Baseline|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~r"
11361438|NCT02297230|BG002|Baseline|Arm 3: Paclitaxel and RT|Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.
11361439|NCT02297230|BG003|Baseline|Arm 4: Paclitaxel/Trastuzumab and RT|Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.
11361440|NCT02297230|BG004|Baseline|Total|Total of all reporting groups
11361441|NCT02297230|FG000|Participant Flow|Arm 1 Capecitabine and RT|"Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks"
11361442|NCT02297230|FG001|Participant Flow|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the"
11361443|NCT02297230|FG002|Participant Flow|Arm 3: Paclitaxel and RT|Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with
11361444|NCT02297230|FG003|Participant Flow|Arm 4: Paclitaxel/Trastuzumab and RT|Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.
11361445|NCT02297230|OG000|Outcome|Arm 1 Capecitabine and RT|"Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks"
11361446|NCT02297230|OG001|Outcome|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the"
11361447|NCT02297230|OG002|Outcome|Arm 3: Paclitaxel and RT|Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with
11361448|NCT02297230|OG003|Outcome|Arm 4: Paclitaxel/Trastuzumab and RT|Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.
11361449|NCT02297230|OG002|Outcome|Arm 3: Paclitaxel and RT|"Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.~Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total."
11361450|NCT02297230|OG003|Outcome|Arm 4: Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients.~Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surger"
11361451|NCT02297230|OG000|Outcome|Arm 1 Capecitabine and RT|"radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation)."
11361452|NCT02297230|OG001|Outcome|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel.~Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour."
11361453|NCT02297230|OG002|Outcome|Arm 3: Paclitaxel and RT|"Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. -~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with"
11361454|NCT02297230|OG003|Outcome|Arm 4: Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor."
11361455|NCT02297230|EG000|Reported Event|Arm 1 Capecitabine and RT|"radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation)."
11361456|NCT02297230|EG001|Reported Event|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel.~Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour."
11188393|NCT02113189|FG001|Participant Flow|Individualized Walking Program|"This group will receive a customized walking program.~Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking"
10962206|NCT00865566|BG001|Baseline|Placebo|"Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid~HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid"
10962207|NCT00865566|BG002|Baseline|Total|Total of all reporting groups
10962208|NCT00865566|FG000|Participant Flow|Vaccine|"Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid~Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid"
10962209|NCT00865566|FG001|Participant Flow|Placebo|"Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid~HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid"
10962210|NCT00865566|OG000|Outcome|Vaccine|"Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid~Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid"
10962211|NCT00865566|OG001|Outcome|Placebo|"Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid~HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid"
10962212|NCT00865566|EG000|Reported Event|Vaccine|"Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid~Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid"
10962213|NCT00865566|EG001|Reported Event|Placebo|"Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid~HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid"
10963907|NCT00874848|FG000|Participant Flow|Imprime PGG Arm|"Imprime PGG® infusion:~4 mg/kg i.v. over 2 to 4 hrs on Days 1, 8 and 15 of each 3-week treatment cycle;~Cetuximab infusion:~initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;~Paclitaxel infusion:~200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles~Carboplatin infusion:~dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.~Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of Imprime PGG and cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
10963908|NCT00874848|FG001|Participant Flow|Control Arm|"Cetuximab infusion:~initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;~Paclitaxel infusion:~200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles~Carboplatin infusion:~dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.~Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
10963909|NCT00874848|OG000|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
10963910|NCT00874848|OG001|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
10963911|NCT00874848|EG000|Reported Event|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
10963912|NCT00874848|EG001|Reported Event|Control Arm|Cetuximab + Paclitaxel/Carboplatin
10963913|NCT00874887|BG000|Baseline|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
10963914|NCT00874887|BG001|Baseline|Zymar®|Gatifloxacin 0.3% ophthalmic solution
11188394|NCT02113189|FG002|Participant Flow|Walking Program With Custom Braces|"This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.~Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on."
10963915|NCT00874887|BG002|Baseline|Total|Total of all reporting groups
10963916|NCT00874887|FG000|Participant Flow|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
10963917|NCT00874887|FG001|Participant Flow|Zymar®|Gatifloxacin 0.3% ophthalmic solution
10963918|NCT00874887|OG000|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
10963919|NCT00874887|OG001|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
10963920|NCT00874887|EG000|Reported Event|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
10963921|NCT00874887|EG001|Reported Event|Zymar®|Gatifloxacin 0.3% ophthalmic solution
10962214|NCT00865709|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
10962215|NCT00865709|BG001|Baseline|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
10962216|NCT00865709|BG002|Baseline|Total|Total of all reporting groups
10962217|NCT00865709|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
10962218|NCT00865709|FG001|Participant Flow|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
10962219|NCT00865709|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
10962220|NCT00865709|OG001|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
10962221|NCT00865709|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
10962222|NCT00865709|EG001|Reported Event|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
10962223|NCT00865709|EG002|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (OS Update)|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
10962224|NCT00865709|EG003|Reported Event|Matching Placebo + mFOLFOX6 (OS Update)|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
10962225|NCT00865904|BG000|Baseline|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
10962226|NCT00865904|BG001|Baseline|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
10962227|NCT00865904|BG002|Baseline|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
10962228|NCT00865904|BG003|Baseline|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
10962229|NCT00865904|BG004|Baseline|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
10962230|NCT00865904|BG005|Baseline|Total|Total of all reporting groups
10962231|NCT00865904|FG000|Participant Flow|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
10962232|NCT00865904|FG001|Participant Flow|VX-809, 25 mg|VX-809, 25 milligram (mg) capsule orally once daily for 28 days.
10962233|NCT00865904|FG002|Participant Flow|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
10962234|NCT00865904|FG003|Participant Flow|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
10962235|NCT00865904|FG004|Participant Flow|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
10962236|NCT00865904|OG000|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
10962237|NCT00865904|OG001|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
10962238|NCT00865904|OG002|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
10962239|NCT00865904|OG003|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
10962240|NCT00865904|OG004|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
10962241|NCT00865904|OG000|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
10962242|NCT00865904|OG001|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
10962243|NCT00865904|OG002|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
10962244|NCT00865904|OG003|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
10962245|NCT00865904|EG000|Reported Event|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
10962246|NCT00865904|EG001|Reported Event|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
10962247|NCT00865904|EG002|Reported Event|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
10962248|NCT00865904|EG003|Reported Event|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
10962249|NCT00865904|EG004|Reported Event|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
10962250|NCT00865969|BG000|Baseline|Belinostat|Belinostat 1000 mg/m^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
10962251|NCT00865969|FG000|Participant Flow|Belinostat|Belinostat 1000mg/m^2 administered as a 30 minute IV infusion from Days 1-5 of a 3-week cycle until disease progression or unmanageable treatment-related toxicities.
10962252|NCT00865969|OG000|Outcome|Belinostat|Belinostat 1000 mg/m^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
10962253|NCT00865969|EG000|Reported Event|Belinostat|Belinostat 1000 mg/m^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
10962254|NCT00866034|BG000|Baseline|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
10962255|NCT00866034|BG001|Baseline|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
10962256|NCT00866034|BG002|Baseline|Total|Total of all reporting groups
10962257|NCT00866034|FG000|Participant Flow|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
11361457|NCT02297230|EG002|Reported Event|Arm 3: Paclitaxel and RT|"Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. -~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with"
11361458|NCT02297230|EG003|Reported Event|Arm 4: Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor."
11361459|NCT02294981|BG000|Baseline|Conventional Dosing/Plaque Based Dosing|"Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses.~Excimer laser phototherapy: Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated)."
10962258|NCT00866034|FG001|Participant Flow|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
10962259|NCT00866034|OG000|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
10962260|NCT00866034|OG001|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
10962261|NCT00866034|EG000|Reported Event|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
10962262|NCT00866034|EG001|Reported Event|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
10962263|NCT00866047|BG000|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
10962264|NCT00866047|FG000|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
10962265|NCT00866047|OG000|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
10962266|NCT00866047|EG000|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
10962267|NCT00866177|BG000|Baseline|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10962268|NCT00866177|FG000|Participant Flow|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10962269|NCT00866177|OG000|Outcome|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10962270|NCT00866177|EG000|Reported Event|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10962271|NCT00866281|BG000|Baseline|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received body-weight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
10962272|NCT00866281|BG001|Baseline|Cohort 2: Midostaurin (60 mg/m^2)|Participants received body-weight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
10962273|NCT00866281|BG002|Baseline|Total|Total of all reporting groups
10962274|NCT00866281|FG000|Participant Flow|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 twice daily (bid) through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
10962275|NCT00866281|FG001|Participant Flow|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
10962276|NCT00866281|OG000|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
10962277|NCT00866281|OG001|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
10962278|NCT00866281|OG000|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body-weight stratified dosage midostaurin 30 or 60 mg/m^2.
10962279|NCT00866281|OG001|Outcome|MLLr-ALL Subjects|Subjects with mixed lineage leukemia gene- rearranged acute lymphoblastic leukemia (MLLr-ALL) and received body-weight stratified dosage midostaurin 30 or 60 mg/m^2.
10962280|NCT00866281|OG000|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
10962281|NCT00866281|EG000|Reported Event|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
10962282|NCT00866281|EG001|Reported Event|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
10962283|NCT00866294|BG000|Baseline|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
10962284|NCT00866294|BG001|Baseline|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
10962285|NCT00866294|BG002|Baseline|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
10962286|NCT00866294|BG003|Baseline|Total|Total of all reporting groups
10962287|NCT00866294|FG000|Participant Flow|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
11361460|NCT02294981|FG000|Participant Flow|Conventional Dosing/Plaque Based Dosing|"Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses.~Excimer laser phototherapy: Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated)."
11361461|NCT02294981|OG000|Outcome|Conventional Dosing/Plaque Based Dosing|"Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses.~Excimer laser phototherapy: Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated)."
11361462|NCT02294981|EG000|Reported Event|Conventional Dosing/Plaque Based Dosing|"Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses.~Excimer laser phototherapy: Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated)."
10962288|NCT00866294|FG001|Participant Flow|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
10962289|NCT00866294|FG002|Participant Flow|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
11361463|NCT02284906|BG000|Baseline|Low Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily, for 10 months to participants assigned to low risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361464|NCT02284906|BG001|Baseline|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily, for minimum of 3 years to participants assigned to high risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361465|NCT02284906|BG002|Baseline|High Risk Pioglitazone|Pioglitazone 0.8 mg tablets, orally, once daily for 3 years to participants assigned to high risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361466|NCT02284906|BG003|Baseline|Total|Total of all reporting groups
11361467|NCT02284906|FG000|Participant Flow|Low Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily, for 10 months to participants assigned to low risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
10962290|NCT00866294|OG000|Outcome|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
10962291|NCT00866294|OG001|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
10962292|NCT00866294|OG002|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
10962293|NCT00866294|OG000|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
10962294|NCT00866294|OG001|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
10962295|NCT00866294|OG002|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
10962296|NCT00866294|OG001|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
10962297|NCT00866294|EG000|Reported Event|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
10962298|NCT00866294|EG001|Reported Event|Paroxetine CR 12.5-50 mg/Day|An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
11361468|NCT02284906|FG001|Participant Flow|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily, for minimum of 3 years to participants assigned to high risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361469|NCT02284906|FG002|Participant Flow|High Risk Pioglitazone|Pioglitazone 0.8 mg tablets, orally, once daily for 3 years to participants assigned to high risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361470|NCT02284906|OG000|Outcome|Low Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily, for 10 months to participants assigned to low risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361471|NCT02284906|OG001|Outcome|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily, for minimum of 3 years to participants assigned to high risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361472|NCT02284906|OG002|Outcome|High Risk Pioglitazone 0.8 mg|Pioglitazone 0.8 mg tablets, orally, once daily for 3 years to participants assigned to high risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361473|NCT02284906|EG000|Reported Event|Low Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily, for 10 months to participants assigned to low risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361474|NCT02284906|EG001|Reported Event|High Risk Placebo|Pioglitazone placebo-matching tablets, orally, once daily, for minimum of 3 years to participants assigned to high risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361475|NCT02284906|EG002|Reported Event|High Risk Pioglitazone|Pioglitazone 0.8 mg tablets, orally, once daily for 3 years to participants assigned to high risk group for developing MCI- AD within the next five years in previous study (AD-4833/TOMM40_301).
11361476|NCT02287025|BG000|Baseline|SMART|Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
11361477|NCT02287025|BG001|Baseline|Standard of Care|Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with standard prescribing information.
11361478|NCT02287025|BG002|Baseline|Total|Total of all reporting groups
11361479|NCT02287025|FG000|Participant Flow|SMART|Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
11361480|NCT02287025|FG001|Participant Flow|Standard of Care|Investigators were supported with standard prescribing information.
11361481|NCT02287025|OG000|Outcome|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
11361482|NCT02287025|EG000|Reported Event|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
11361483|NCT02282332|BG000|Baseline|Patiens Discharged on Ticagrelor|"Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.~Ticagrelor"
11361484|NCT02282332|FG000|Participant Flow|Patiens Discharged on Ticagrelor|"Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.~Ticagrelor"
11361485|NCT02282332|OG000|Outcome|Patiens Discharged on Ticagrelor|"Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.~Ticagrelor"
11361486|NCT02282332|EG000|Reported Event|Patiens Discharged on Ticagrelor|"Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.~Ticagrelor"
10962299|NCT00866294|EG002|Reported Event|Paroxetine CR 25-50 mg/Day|An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
11361487|NCT02287636|BG000|Baseline|Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI)|"Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT~positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT~computed tomography: Undergo fludeoxyglucose F 18 PET/CT~positron emission tomography: Undergo PET/MRI~magnetic resonance imaging: Undergo PET/MRI"
11361488|NCT02287636|FG000|Participant Flow|Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI)|"Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT~positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT~computed tomography: Undergo fludeoxyglucose F 18 PET/CT~positron emission tomography: Undergo PET/MRI~magnetic resonance imaging: Undergo PET/MRI"
11361489|NCT02287636|OG000|Outcome|Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI)|"Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT~positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT~computed tomography: Undergo fludeoxyglucose F 18 PET/CT~positron emission tomography: Undergo PET/MRI~magnetic resonance imaging: Undergo PET/MRI"
11361490|NCT02287636|EG000|Reported Event|Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI)|"Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT~positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT~computed tomography: Undergo fludeoxyglucose F 18 PET/CT~positron emission tomography: Undergo PET/MRI~magnetic resonance imaging: Undergo PET/MRI"
11361491|NCT02276560|BG000|Baseline|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
11361492|NCT02276560|BG001|Baseline|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
11361493|NCT02276560|BG002|Baseline|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
11361494|NCT02276560|BG003|Baseline|Total|Total of all reporting groups
11361495|NCT02276560|FG000|Participant Flow|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
11361496|NCT02276560|FG001|Participant Flow|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
11361497|NCT02276560|FG002|Participant Flow|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
11361498|NCT02276560|OG000|Outcome|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
11361499|NCT02276560|OG001|Outcome|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
10962300|NCT00866294|EG003|Reported Event|Paroxetine CR, Total|All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day
10962301|NCT00866294|EG004|Reported Event|Paroxetine IR 10-40 mg/Day|An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
10962302|NCT00866294|EG005|Reported Event|Paroxetine IR 20-40 mg/Day|An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
10962303|NCT00866294|EG006|Reported Event|Paroxetine IR, Total|All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day
10962304|NCT00866307|BG000|Baseline|Induction|All Patients
11361500|NCT02276560|OG002|Outcome|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
11361501|NCT02276560|EG000|Reported Event|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
11361502|NCT02276560|EG001|Reported Event|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
11361503|NCT02276560|EG002|Reported Event|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
10962305|NCT00866307|FG000|Participant Flow|Induction|All Patients
10962306|NCT00866307|FG001|Participant Flow|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM)
11188395|NCT02113189|OG000|Outcome|Walking Program With Ankle Brace|"This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.~Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on."
11361504|NCT02280252|BG000|Baseline|Concurrent Paclitaxel and RT|"Patients will be administered pre-operatively over 12 weeks either:~Paclitaxel, 30mg/m^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule~Abraxane, 30mg/m^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule~Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7:~Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions)~Paclitaxel: Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.~Radiation therapy: Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)"
11377049|NCT00346164|OG000|Outcome|Arm A: No Adjuvant Treatment|"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery"
10962307|NCT00866307|FG002|Participant Flow|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
10962308|NCT00866307|OG000|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
10962309|NCT00866307|EG000|Reported Event|Induction|All Patients
10962310|NCT00866307|EG001|Reported Event|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM).
10962311|NCT00866307|EG002|Reported Event|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
10962312|NCT00866320|BG000|Baseline|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
10962313|NCT00866320|FG000|Participant Flow|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
10962314|NCT00866320|OG000|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
10962315|NCT00866320|OG000|Outcome|Sorafenib|Sorafenib twice a day until progression or toxicity
10962316|NCT00866320|OG000|Outcome|Sorafenib|Patients receive Sorafenib twice a day until disease progression or toxicity
11188396|NCT02113189|OG001|Outcome|Individualized Walking Program|"This group will receive a customized walking program.~Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking"
10962317|NCT00866320|EG000|Reported Event|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
10962318|NCT00866333|BG000|Baseline|Regimen 1: Entinostat 10 mg|Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.
10962319|NCT00866333|BG001|Baseline|Regimen 2: Entinostat 10 mg/15 mg|Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.
10962320|NCT00866333|BG002|Baseline|Regimen 3: Entinostat 15 mg|Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity.
10962321|NCT00866333|BG003|Baseline|Total|Total of all reporting groups
10962322|NCT00866333|FG000|Participant Flow|Regimen 1: Entinostat 10 mg|Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.
10962323|NCT00866333|FG001|Participant Flow|Regimen 2: Entinostat 10 mg/15 mg|Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.
10962324|NCT00866333|FG002|Participant Flow|Regimen 3: Entinostat 15 mg|Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity.
10962325|NCT00866333|OG000|Outcome|Regimen 1: Entinostat 10 mg|Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.
10962326|NCT00866333|OG001|Outcome|Regimen 2: Entinostat 10 mg/15 mg|Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.
10962327|NCT00866333|OG002|Outcome|Regimen 3: Entinostat 15 mg|Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity.
10962328|NCT00866333|EG000|Reported Event|Regimen 1: Entinostat 10 mg|Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.
10962329|NCT00866333|EG001|Reported Event|Regimen 2: Entinostat 10 mg/15 mg|Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.
10962330|NCT00866333|EG002|Reported Event|Regimen 3: Entinostat 15 mg|Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity.
10962331|NCT00866359|BG000|Baseline|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
10962332|NCT00866359|BG001|Baseline|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
10962333|NCT00866359|BG002|Baseline|Total|Total of all reporting groups
10962334|NCT00866359|FG000|Participant Flow|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
10962335|NCT00866359|FG001|Participant Flow|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
10962336|NCT00866359|FG002|Participant Flow|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
10962337|NCT00866359|FG003|Participant Flow|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast BID tablets in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
10962338|NCT00866359|OG000|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
10962339|NCT00866359|OG001|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
10962340|NCT00866359|OG000|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
10962341|NCT00866359|OG000|Outcome|Placebo|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
10962342|NCT00866359|OG000|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
10962343|NCT00866359|OG001|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
10962344|NCT00866359|OG000|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
10962345|NCT00866359|OG001|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
10962346|NCT00866359|OG000|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
10962347|NCT00866359|OG001|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially administered to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
10962348|NCT00866359|OG001|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
10962349|NCT00866359|OG000|Outcome|Placebo BID/Apremilast 30 BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase .
10962350|NCT00866359|OG001|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
10962351|NCT00866359|OG001|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID were titrated to 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
10962352|NCT00866359|OG001|Outcome|Apremilast 30mg/Apremilast 30mg|Treatment and Extension Phases (Days 1 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
10962353|NCT00866359|OG000|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
10962354|NCT00866359|OG001|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
10962355|NCT00866359|OG001|Outcome|Apremilast 30mg/Apremilast 30mg|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
10962356|NCT00866359|OG000|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
10962357|NCT00866359|OG001|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
10962358|NCT00866359|OG001|Outcome|Apremilast 30 mg/Apremilast 30mg BID|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
10962359|NCT00866359|OG000|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
10962360|NCT00866359|EG000|Reported Event|Week 12: Placebo BID|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 12 for all participants randomized to placebo.
10962361|NCT00866359|EG001|Reported Event|Week 12: Apremilast 30 mg BID|Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Includes data through Week 12 for all participants randomized to 30mg Apremilast BID.
10962362|NCT00866359|EG002|Reported Event|Week 24: Apremilast 30 mg BID|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24. Includes data through Week 24 for participants who were treated with Apremilast started at Week 0 and data from Week 12 through Week 24 for participants who were treated with Apremilast started at Week 12.
10962363|NCT00866606|BG000|Baseline|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
10962364|NCT00866606|FG000|Participant Flow|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
10962365|NCT00866606|OG000|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
10962366|NCT00866606|EG000|Reported Event|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
10962367|NCT00866619|BG000|Baseline|GSK257049 [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962368|NCT00866619|BG001|Baseline|GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962369|NCT00866619|BG002|Baseline|VeroRab Comparator [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962370|NCT00866619|BG003|Baseline|Menjugate Comparator [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962371|NCT00866619|BG004|Baseline|Total|Total of all reporting groups
10962372|NCT00866619|FG000|Participant Flow|GSK257049 [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962373|NCT00866619|FG001|Participant Flow|GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962374|NCT00866619|FG002|Participant Flow|VeroRab Comparator [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962375|NCT00866619|FG003|Participant Flow|Menjugate Comparator [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962376|NCT00866619|OG000|Outcome|GSK257049 [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962377|NCT00866619|OG001|Outcome|VeroRab Comparator [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962378|NCT00866619|OG000|Outcome|GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
11361505|NCT02280252|FG000|Participant Flow|Concurrent Paclitaxel and RT|"Patients will be administered pre-operatively over 12 weeks either:~Paclitaxel, 30mg/m^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule~Abraxane, 30mg/m^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule~Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7:~Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions)~Paclitaxel: Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.~Radiation therapy: Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)"
11361506|NCT02280252|OG000|Outcome|Concurrent Paclitaxel and RT|"Patients will be administered pre-operatively over 12 weeks either:~Paclitaxel, 30mg/m^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule~Abraxane, 30mg/m^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule~Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7:~Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions)~Paclitaxel: Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.~Radiation therapy: Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)"
11361507|NCT02280252|EG000|Reported Event|Concurrent Paclitaxel and RT|"Patients will be administered pre-operatively over 12 weeks either:~Paclitaxel, 30mg/m^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule~Abraxane, 30mg/m^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule~Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7:~Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions)~Paclitaxel: Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.~Radiation therapy: Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)"
11361508|NCT02284373|BG000|Baseline|Randomization Arm 1:|"70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded~Flexitouch for 1 month in addition to routine wound care: simultaneous wound care and pneumonic compression"
11361509|NCT02284373|BG001|Baseline|Randomization Arm 2:|"70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.~Routine wound care for venous ulcers and lymphedema: wound care /dressings"
11361510|NCT02284373|BG002|Baseline|Observational Arm 3|"50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.~Flexitouch pneumonic compression: pneumonic compression only"
11361511|NCT02284373|BG003|Baseline|Total|Total of all reporting groups
11361512|NCT02284373|FG000|Participant Flow|Randomization Arm 1:|"70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded~Flexitouch for 1 month in addition to routine wound care: simultaneous wound care and pneumonic compression"
11361513|NCT02284373|FG001|Participant Flow|Randomization Arm 2:|"70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.~Routine wound care for venous ulcers and lymphedema: wound care /dressings"
11361514|NCT02284373|FG002|Participant Flow|Observational Arm 3|"50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.~Flexitouch pneumonic compression: pneumonic compression only"
11361515|NCT02284373|OG000|Outcome|Randomization Arm 1:|"70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded~Flexitouch for 1 month in addition to routine wound care: simultaneous wound care and pneumonic compression"
11361516|NCT02284373|OG001|Outcome|Randomization Arm 2:|"70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.~Routine wound care for venous ulcers and lymphedema: wound care /dressings"
11361517|NCT02284373|OG002|Outcome|Observational Arm 3|"50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.~Flexitouch pneumonic compression: pneumonic compression only"
11361518|NCT02284373|EG000|Reported Event|Randomization Arm 1:|"70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded~Flexitouch for 1 month in addition to routine wound care: simultaneous wound care and pneumonic compression"
11361519|NCT02284373|EG001|Reported Event|Randomization Arm 2:|"70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.~Routine wound care for venous ulcers and lymphedema: wound care /dressings"
11361520|NCT02284373|EG002|Reported Event|Observational Arm 3|"50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.~Flexitouch pneumonic compression: pneumonic compression only"
11361521|NCT02285270|BG000|Baseline|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
11361522|NCT02285270|FG000|Participant Flow|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
11361523|NCT02285270|OG000|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
11361524|NCT02285270|EG000|Reported Event|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
11361525|NCT02275481|BG000|Baseline|BROVANA|"Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor~Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor"
11361526|NCT02275481|BG001|Baseline|SPIRIVA|"Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.~Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®."
11361527|NCT02275481|BG002|Baseline|Total|Total of all reporting groups
11361528|NCT02275481|FG000|Participant Flow|BROVANA|"Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor~Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor"
11361529|NCT02275481|FG001|Participant Flow|SPIRIVA|"Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.~Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®."
11361530|NCT02275481|OG000|Outcome|BROVANA|"Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor~Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor"
11361531|NCT02275481|OG001|Outcome|SPIRIVA|"Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.~Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®."
11361532|NCT02275481|EG000|Reported Event|BROVANA|"Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor~Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor"
11361533|NCT02275481|EG001|Reported Event|SPIRIVA|"Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.~Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®."
11361534|NCT02266914|BG000|Baseline|Cardiac Transplant Patients|"Patients who have received a cardiac transplant at The Ohio State University Ross Heart Hospital will undergo Magnetic Resonance Elastography (MRE) (using a Magnetic Resonance Elastography driver) within 24-48 hours of standard of care biopsy. Results of both will be compared to determine if MRE can successfully predict cardiac transplant rejection.~Magnetic Resonance Elastography driver: A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ."
11361535|NCT02266914|FG000|Participant Flow|Cardiac Transplant Patients|"Patients who have received a cardiac transplant at The Ohio State University Ross Heart Hospital will undergo Magnetic Resonance Elastography (MRE) (using a Magnetic Resonance Elastography driver) within 24-48 hours of standard of care biopsy. Results of both will be compared to determine if MRE can successfully predict cardiac transplant rejection.~Magnetic Resonance Elastography driver: A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ."
11361536|NCT02266914|OG000|Outcome|Cardiac Transplant Patients|"Patients who have received a cardiac transplant at The Ohio State University Ross Heart Hospital will undergo Magnetic Resonance Elastography (MRE) (using a Magnetic Resonance Elastography driver) within 24-48 hours of standard of care biopsy. Results of both will be compared to determine if MRE can successfully predict cardiac transplant rejection.~Magnetic Resonance Elastography driver: A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ."
11361537|NCT02266914|EG000|Reported Event|Cardiac Transplant Patients|"Patients who have received a cardiac transplant at The Ohio State University Ross Heart Hospital will undergo Magnetic Resonance Elastography (MRE) (using a Magnetic Resonance Elastography driver) within 24-48 hours of standard of care biopsy. Results of both will be compared to determine if MRE can successfully predict cardiac transplant rejection.~Magnetic Resonance Elastography driver: A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ."
11361538|NCT02273752|BG000|Baseline|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
11361539|NCT02273752|FG000|Participant Flow|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic therapeutic drug monitoring (TDM) on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
11361540|NCT02273752|OG000|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
11361541|NCT02273752|EG000|Reported Event|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
10963922|NCT00875017|BG000|Baseline|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
10963923|NCT00875017|BG001|Baseline|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
10962379|NCT00866619|OG001|Outcome|Menjugate Comparator [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962380|NCT00866619|OG001|Outcome|GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962381|NCT00866619|OG002|Outcome|VeroRab Comparator [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962382|NCT00866619|OG003|Outcome|Menjugate Comparator [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962383|NCT00866619|OG000|Outcome|GSK257049 - GSK257049 [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962384|NCT00866619|OG001|Outcome|GSK257049 - Menjugate [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962385|NCT00866619|OG003|Outcome|GSK257049 -GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962386|NCT00866619|OG004|Outcome|GSK257049 - Menjugate [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962387|NCT00866619|OG005|Outcome|Menjugate Comparator [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
11188397|NCT02113189|OG002|Outcome|Walking Program With Custom Braces|"This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.~Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on."
10962388|NCT00866619|OG000|Outcome|GSK257049 Group|For the purpose of the analysis, GSK257049 [5-17M] and GSK257049 [6-12W] groups have been pooled into a single group.
10962389|NCT00866619|OG001|Outcome|Comparator Group|For the purpose of the analysis, VeroRab Comparator [5-17M] and Menjugate Comparator [6-12W] groups have been pooled into a single group.
10963924|NCT00875017|BG002|Baseline|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
11188398|NCT02113189|OG000|Outcome|Walking Program With Ankle Brace|This group will receive off-the-shelf ankle braces as well as a customized walking program. Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with bilateral ankle braces on.
11188399|NCT02113189|OG001|Outcome|Individualized Walking Program|This group will receive a customized walking program. Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking.
11361542|NCT02270684|BG000|Baseline|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
11361543|NCT02270684|BG001|Baseline|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
11361544|NCT02270684|BG002|Baseline|Total|Total of all reporting groups
11361545|NCT02270684|FG000|Participant Flow|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
11361546|NCT02270684|FG001|Participant Flow|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
11361547|NCT02270684|OG000|Outcome|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
11361548|NCT02270684|OG001|Outcome|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
11361549|NCT02270684|EG000|Reported Event|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
11361550|NCT02270684|EG001|Reported Event|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
11361551|NCT02262000|BG000|Baseline|A - 7.5 Gy x 10 Daily Fractions|"Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.~Image Guided Stereotactic Ablative Radiotherapy"
11361552|NCT02262000|BG001|Baseline|B - 12 Gy x 5 Daily Fractions|"Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved~Image Guided Stereotactic Ablative Radiotherapy"
11361553|NCT02262000|BG002|Baseline|Total|Total of all reporting groups
11361554|NCT02262000|FG000|Participant Flow|A - 7.5 Gy x 10 Daily Fractions|"Radiotherapy: 7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT) at West Virginia University.~Image Guided Stereotactic Ablative Radiotherapy"
11361555|NCT02262000|FG001|Participant Flow|B - 12 Gy x 5 Daily Fractions|"Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved~Image Guided Stereotactic Ablative Radiotherapy"
11361556|NCT02262000|OG000|Outcome|A - 7.5 Gy x 10 Daily Fractions|"Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.~Image Guided Stereotactic Ablative Radiotherapy"
11361557|NCT02262000|OG001|Outcome|B - 12 Gy x 5 Daily Fractions|"Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved~Image Guided Stereotactic Ablative Radiotherapy"
11361558|NCT02262000|EG000|Reported Event|A - 7.5 Gy x 10 Daily Fractions|"Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.~Image Guided Stereotactic Ablative Radiotherapy"
11361559|NCT02262000|EG001|Reported Event|B - 12 Gy x 5 Daily Fractions|"Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved~Image Guided Stereotactic Ablative Radiotherapy"
11361560|NCT02271594|BG000|Baseline|Intensive Training|The intervention consists of instructing patients in whom lipohypertrophy (LH) is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles. A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training.
11361561|NCT02271594|BG001|Baseline|Standard Care|Standard care means affording the patients randomized to the control arm the customary education and follow-up usually given at the centre. This would include appraising them of the presence of LH (if they were not previously aware) and stating that injections should not be given into that area. The training approach, tools and intensive follow-up given the Intervention arm patients will not be given to the Controls. Additionally, at their return visit (3 and 6 months), Control patients will be asked if they did indeed change their injection habits (e.g. stopped injecting into LH) since entering the study. Those who did and those who did not will be analysed separately to see if there is a difference in outcomes and both groups will be compared to the Intervention arm patients.
11361562|NCT02271594|BG002|Baseline|Total|Total of all reporting groups
11377050|NCT00346164|OG001|Outcome|Arm B: Low Risk; Adjuvant Radiotherapy|"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy"
11361563|NCT02271594|FG000|Participant Flow|Intensive Training|The intervention consists of instructing patients in whom lipohypertrophy (LH) is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles. A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training.
11361564|NCT02271594|FG001|Participant Flow|Standard Care|Standard care means affording the patients randomized to the control arm the customary education and follow-up usually given at the centre. This would include appraising them of the presence of LH (if they were not previously aware) and stating that injections should not be given into that area. The training approach, tools and intensive follow-up given the Intervention arm patients will not be given to the Controls. Additionally, at their return visit (3 and 6 months), Control patients will be asked if they did indeed change their injection habits (e.g. stopped injecting into LH) since entering the study. Those who did and those who did not will be analysed separately to see if there is a difference in outcomes and both groups will be compared to the Intervention arm patients.
11361565|NCT02271594|OG000|Outcome|Intensive Training|The intervention consists of instructing patients in whom lipohypertrophy (LH) is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles. A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training.
11361566|NCT02271594|OG001|Outcome|Standard Care|Standard care means affording the patients randomized to the control arm the customary education and follow-up usually given at the centre. This would include appraising them of the presence of LH (if they were not previously aware) and stating that injections should not be given into that area. The training approach, tools and intensive follow-up given the Intervention arm patients will not be given to the Controls. Additionally, at their return visit (3 and 6 months), Control patients will be asked if they did indeed change their injection habits (e.g. stopped injecting into LH) since entering the study. Those who did and those who did not will be analysed separately to see if there is a difference in outcomes and both groups will be compared to the Intervention arm patients.
11361567|NCT02271594|OG000|Outcome|Intervention|"Intensive education on injection technique~Intensive Training on Best Insulin Injection Technique: The intervention consists of instructing patients in whom LH is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles. A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training."
11361568|NCT02271594|OG001|Outcome|Control|"Standard education on injection technique~Standard education on injection technique: Usual and customary education and training normally provided injecting patients at the center"
11361569|NCT02271594|EG000|Reported Event|Intensive Training|"The intervention consists of instructing patients in whom lipohypertrophy (LH) is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles. A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training.~Intensive Training on Best Insulin Injection Technique: The intervention consists of instructing patients in whom LH is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20%"
11361570|NCT02271594|EG001|Reported Event|Standard Care|Standard care means affording the patients randomized to the control arm the customary education and follow-up usually given at the centre. This would include appraising them of the presence of LH (if they were not previously aware) and stating that injections should not be given into that area. The training approach, tools and intensive follow-up given the Intervention arm patients will not be given to the Controls. Additionally, at their return visit (3 and 6 months), Control patients will be asked if they did indeed change their injection habits (e.g. stopped injecting into LH) since entering the study. Those who did and those who did not will be analysed separately to see if there is a difference in outcomes and both groups will be compared to the Intervention arm patients.
11361571|NCT02263365|BG000|Baseline|Control|No intervention
11361572|NCT02263365|BG001|Baseline|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
11361573|NCT02263365|BG002|Baseline|Total|Total of all reporting groups
11361574|NCT02263365|FG000|Participant Flow|Control|No intervention
11361575|NCT02263365|FG001|Participant Flow|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
11361576|NCT02263365|OG000|Outcome|Control|No intervention
10963925|NCT00875017|BG003|Baseline|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
11361577|NCT02263365|OG001|Outcome|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
11361578|NCT02263365|OG000|Outcome|Control|
11361579|NCT02263365|EG000|Reported Event|Control|No intervention
11361580|NCT02263365|EG001|Reported Event|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
11361581|NCT02266797|BG000|Baseline|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
11361582|NCT02266797|BG001|Baseline|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
11361583|NCT02266797|BG002|Baseline|Total|Total of all reporting groups
11361584|NCT02266797|FG000|Participant Flow|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
10962390|NCT00866619|OG000|Outcome|GSK257049 - Menjugate [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962391|NCT00866619|OG001|Outcome|GSK257049 - Menjugate [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962392|NCT00866619|OG002|Outcome|GSK257049 - Menjugate [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
11361585|NCT02266797|FG001|Participant Flow|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
11361586|NCT02266797|OG000|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
11361587|NCT02266797|OG001|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
11361588|NCT02266797|EG000|Reported Event|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
11361589|NCT02266797|EG001|Reported Event|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
11361590|NCT02249377|BG000|Baseline|Platelets-Rich-Plasma Group|"Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.~Platelets-Rich-Plasma: Platelet-Rich Plasma"
10962393|NCT00866619|OG001|Outcome|GSK257049 -GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962394|NCT00866619|OG002|Outcome|GSK257049 -GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962395|NCT00866619|OG002|Outcome|GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962396|NCT00866619|OG000|Outcome|GSK257049 -GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962397|NCT00866619|OG002|Outcome|Menjugate Comparator [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962398|NCT00866619|OG000|Outcome|GSK257049 Group|Pooled group between GSK257049 [5-17M] Group and GSK257049 [6-12W] Group.
10962399|NCT00866619|OG001|Outcome|GSK257049 -GSK257049 Group|Pooled group between GSK257049 -GSK257049 [5-17M] Group and GSK257049 -GSK257049 [6-12W] Group.
10962400|NCT00866619|OG002|Outcome|GSK257049 - Menjugate Group|Pooled group between GSK257049 - Menjugate [5-17M] Group and GSK257049 - Menjugate [6-12W] Group.
10962401|NCT00866619|OG003|Outcome|Comparator Group|Pooled Group between VeroRab Comparator [5-17M] Group and Menjugate Comparator [6-12W] Group.
10962402|NCT00866619|OG000|Outcome|GSK257049 -GSK257049 Group|Pooled group between GSK257049 -GSK257049 [5-17M] Group and GSK257049 -GSK257049 [6-12W] Group.
10962403|NCT00866619|OG001|Outcome|GSK257049 - Menjugate Group|Pooled group between GSK257049 - Menjugate [5-17M] Group and GSK257049 - Menjugate [6-12W] Group.
10962404|NCT00866619|OG002|Outcome|Comparator Group|Pooled Group between VeroRab Comparator [5-17M] Group and Menjugate Comparator [6-12W] Group.
10962405|NCT00866619|EG000|Reported Event|GSK257049 [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962406|NCT00866619|EG001|Reported Event|GSK257049 [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962407|NCT00866619|EG002|Reported Event|VeroRab Comparator [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
10962408|NCT00866619|EG003|Reported Event|Menjugate Comparator [6-12W] Group|Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
10962409|NCT00866658|BG000|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10962410|NCT00866658|BG001|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10962411|NCT00866658|BG002|Baseline|Total|Total of all reporting groups
10962412|NCT00866658|FG000|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10962413|NCT00866658|FG001|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
10962414|NCT00866658|OG000|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
10962415|NCT00866658|OG001|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
10962416|NCT00866658|EG000|Reported Event|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
10962417|NCT00866658|EG001|Reported Event|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
10962418|NCT00866697|BG000|Baseline|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
10962419|NCT00866697|BG001|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
10962420|NCT00866697|BG002|Baseline|Total|Total of all reporting groups
10962421|NCT00866697|FG000|Participant Flow|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
10962422|NCT00866697|FG001|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
10962423|NCT00866697|OG000|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
10962424|NCT00866697|OG001|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
10962425|NCT00866697|EG000|Reported Event|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
10962426|NCT00866697|EG001|Reported Event|Pazopanib|Pazopanib
10962427|NCT00866723|BG000|Baseline|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
10962428|NCT00866723|FG000|Participant Flow|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
10962429|NCT00866723|OG000|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
10962430|NCT00866723|EG000|Reported Event|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
10962431|NCT00866749|BG000|Baseline|Augmented BFM Therapy|"Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine~Daunorubicin: Starting Dose 25 mg/m^2 by vein weekly~Vincristine: Starting Dose 2 mg by vein weekly~PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1~Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid~Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5~Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months~Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month~Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10~+/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3~Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3~Thioguanine: 60 mg/m2 by mouth daily for two weeks"
10962432|NCT00866749|FG000|Participant Flow|Augmented BFM Therapy|"Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine~Daunorubicin: Starting Dose 25 mg/m^2 by vein weekly~Vincristine: Starting Dose 2 mg by vein weekly~PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1~Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid~Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5~Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months~Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month~Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10~+/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3~Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3~Thioguanine: 60 mg/m2 by mouth daily for two weeks"
10962433|NCT00866749|OG000|Outcome|Augmented BFM Therapy|"Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine~Daunorubicin: Starting Dose 25 mg/m^2 by vein weekly~Vincristine: Starting Dose 2 mg by vein weekly~PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1~Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid~Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5~Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months~Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month~Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10~+/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3~Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3~Thioguanine: 60 mg/m2 by mouth daily for two weeks"
10962434|NCT00866749|EG000|Reported Event|Augmented BFM Therapy|"Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine~Daunorubicin: Starting Dose 25 mg/m^2 by vein weekly~Vincristine: Starting Dose 2 mg by vein weekly~PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1~Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid~Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5~Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months~Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month~Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10~+/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3~Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3~Thioguanine: 60 mg/m2 by mouth daily for two weeks"
10962435|NCT00866775|BG000|Baseline|Eslicarbazepine 1200 mg QD|"Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.~."
10962436|NCT00866775|BG001|Baseline|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
10962437|NCT00866775|BG002|Baseline|Total|Total of all reporting groups
10962438|NCT00866775|FG000|Participant Flow|Eslicarbazepine 1200 mg QD|"Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.~."
10962439|NCT00866775|FG001|Participant Flow|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
10962440|NCT00866775|OG000|Outcome|Eslicarbazepine 1200 mg QD|"Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.~."
10962441|NCT00866775|OG001|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
10962442|NCT00866775|OG000|Outcome|Eslicarbazepine 1200 mg QD|"Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.~."
10962443|NCT00866775|OG001|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
11361591|NCT02249377|BG001|Baseline|Corticosteroid Group:|"Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.~Corticosteroid: Corticosteroid"
11361592|NCT02249377|BG002|Baseline|Total|Total of all reporting groups
11361593|NCT02249377|FG000|Participant Flow|Platelets-Rich-Plasma Group|"Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.~Platelets-Rich-Plasma: Platelet-Rich Plasma"
11361594|NCT02249377|FG001|Participant Flow|Corticosteroid Group:|"Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.~Corticosteroid: Corticosteroid"
10962444|NCT00866775|EG000|Reported Event|Eslicarbazepine 1200 mg QD|"Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.~."
10962445|NCT00866775|EG001|Reported Event|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
10962446|NCT00866788|BG000|Baseline|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962447|NCT00866788|BG001|Baseline|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962448|NCT00866788|BG002|Baseline|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962449|NCT00866788|BG003|Baseline|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962450|NCT00866788|BG004|Baseline|Total|Total of all reporting groups
10962451|NCT00866788|FG000|Participant Flow|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10963926|NCT00875017|BG004|Baseline|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
11361595|NCT02249377|OG000|Outcome|Platelets-Rich-Plasma Group|"Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.~Platelets-Rich-Plasma: Platelet-Rich Plasma"
10962452|NCT00866788|FG001|Participant Flow|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962453|NCT00866788|FG002|Participant Flow|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962454|NCT00866788|FG003|Participant Flow|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962455|NCT00866788|OG000|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962456|NCT00866788|OG001|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962457|NCT00866788|OG002|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962458|NCT00866788|OG003|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
11361596|NCT02249377|OG001|Outcome|Corticosteroid Group:|"Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.~Corticosteroid: Corticosteroid"
10962459|NCT00866788|OG000|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962460|NCT00866788|OG001|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962461|NCT00866788|OG002|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962462|NCT00866788|EG000|Reported Event|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962463|NCT00866788|EG001|Reported Event|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962464|NCT00866788|EG002|Reported Event|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962465|NCT00866788|EG003|Reported Event|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
10962466|NCT00866814|BG000|Baseline|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
10962467|NCT00866814|FG000|Participant Flow|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
10962468|NCT00866814|OG000|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
10962469|NCT00866814|EG000|Reported Event|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
11361597|NCT02249377|EG000|Reported Event|Platelets-Rich-Plasma Group|"Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.~Platelets-Rich-Plasma: Platelet-Rich Plasma"
11361598|NCT02249377|EG001|Reported Event|Corticosteroid Group:|"Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.~Corticosteroid: Corticosteroid"
11361599|NCT02253394|BG000|Baseline|AMB + Spiro, Cardiopulmonary Fitness|"Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD~Ambrisentan plus Spironolactone: Cardiopulmonary fitness~Cross over design"
11361600|NCT02253394|FG000|Participant Flow|AMB + Spiro First, Then Placebo, Cardiopulmonary Fitness|Ambrisentan 5 or 10 mg every day (QD) plus Spironolactone 50 mg QD FIRST, then placebo
11361601|NCT02253394|FG001|Participant Flow|AMB + Placebo First, Then Spironolactone|Ambrisentan 5 or 10 mg every day (QD) plus placebo first, then spironolactone 50 mg QD
11361602|NCT02253394|OG000|Outcome|AMB + Spiro, Cardiopulmonary Fitness|Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD
11361603|NCT02253394|OG001|Outcome|AMB + Placebo First|Ambrisentan 5 or 10 mg QD + placebo
11361604|NCT02253394|EG000|Reported Event|AMB + Spiro, Cardiopulmonary Fitness|"Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD~Ambrisentan plus Spironolactone: Cardiopulmonary fitness"
11361605|NCT02253394|EG001|Reported Event|Placebo Cardiopulmonary Fitness|"Placebo mimics spironolactone 50 mg and will be taken QD~Ambrisentan plus Placebo: Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness"
11361606|NCT02241551|BG000|Baseline|Gemcitabine/Nab-paclitaxel|Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
11361607|NCT02241551|BG001|Baseline|mFOLFIRINOX|Patients that received 6 cycles in the mFOLFIRINOX
11361608|NCT02241551|BG002|Baseline|Total|Total of all reporting groups
11361609|NCT02241551|FG000|Participant Flow|Gemcitabine/Nab-paclitaxel|Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
11361610|NCT02241551|FG001|Participant Flow|mFOLFIRINOX|Patients that received 6 cycles in the mFOLFIRINOX
11361611|NCT02241551|OG000|Outcome|Gemcitabine/Nab-paclitaxel|Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
11361612|NCT02241551|OG001|Outcome|mFOLFIRINOX|Patients that received 6 cycles in the mFOLFIRINOX
11361613|NCT02241551|OG000|Outcome|Gemcitabine/Nab-paclitaxel|"three cycles of treatment in the gemcitabine/nab-paclitaxel~gemcitabine/nab-paclitaxel: three cycles of treatment in the gemcitabine/nab-paclitaxel"
11361614|NCT02241551|OG001|Outcome|mFOLFIRINOX|"6 cycles in the mFOLFIRINOX~mFOLFIRINOX: 6 cycles in the mFOLFIRINOX"
11361615|NCT02241551|EG000|Reported Event|Gemcitabine/Nab-paclitaxel|Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
11361616|NCT02241551|EG001|Reported Event|mFOLFIRINOX|Patients that received 6 cycles in the mFOLFIRINOX
11361617|NCT02246114|BG000|Baseline|Arm A|no CO monitor
11361618|NCT02246114|BG001|Baseline|Arm B|CO monitor
11361619|NCT02246114|BG002|Baseline|Total|Total of all reporting groups
11361620|NCT02246114|FG000|Participant Flow|Arm A|no CO monitor
11361621|NCT02246114|FG001|Participant Flow|Arm B|CO monitor
11361622|NCT02246114|OG000|Outcome|Arm A|no CO monitor
11361623|NCT02246114|OG001|Outcome|Arm B|CO monitor
11361624|NCT02246114|EG000|Reported Event|Arm A (no CO Monitor)|no CO monitor
11361625|NCT02246114|EG001|Reported Event|Arm B (CO Monitor)|CO monitor
11361626|NCT02232880|BG000|Baseline|Consented Patients|No patients received treatment prior to study termination
11361627|NCT02232880|FG000|Participant Flow|Consented Patients|
11361628|NCT02232880|OG000|Outcome|Consented Patients|
11361629|NCT02232880|EG000|Reported Event|Consented Patients|No patients received treatment prior to study termination
11361630|NCT02248740|BG000|Baseline|Radiofrequency Ablation|"Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.~Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment."
11361631|NCT02248740|BG001|Baseline|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.~Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment."
11361632|NCT02248740|BG002|Baseline|Total|Total of all reporting groups
10962470|NCT00866879|BG000|Baseline|Control|Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus.
10962471|NCT00866879|BG001|Baseline|Transition to Sirolimus Group|Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus
10962472|NCT00866879|BG002|Baseline|Total|Total of all reporting groups
10962473|NCT00866879|FG000|Participant Flow|Control|Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus.
10962474|NCT00866879|FG001|Participant Flow|Transition to Sirolimus Group|Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus
11239648|NCT02472457|BG001|Baseline|Crohn Disease Exclusion Diet|"The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.~Crohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II."
11239649|NCT02472457|BG002|Baseline|Total|Total of all reporting groups
11239650|NCT02472457|FG000|Participant Flow|Free Diet|"No dietary restrictions~Free Diet: This diet contains no restrictions."
11239651|NCT02472457|FG001|Participant Flow|Crohn Disease Exclusion Diet|"The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.~Crohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II."
11239652|NCT02472457|OG000|Outcome|Free Diet|"No dietary restrictions~Free Diet: This diet contains no restrictions."
11239653|NCT02472457|OG001|Outcome|Crohn Disease Exclusion Diet|"The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.~Crohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II."
11239654|NCT02472457|EG000|Reported Event|Free Diet|"No dietary restrictions~Free Diet: This diet contains no restrictions."
11239655|NCT02472457|EG001|Reported Event|Crohn Disease Exclusion Diet|"The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.~Crohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II."
11239656|NCT02472522|BG000|Baseline|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
11239657|NCT02472522|BG001|Baseline|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
10962475|NCT00866879|OG000|Outcome|Control|Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus.
10962476|NCT00866879|OG001|Outcome|Transition to Sirolimus Group|Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus
10962477|NCT00866879|EG000|Reported Event|Control|Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. Patients were followed for 24 months post randomization
10962478|NCT00866879|EG001|Reported Event|Transition to Sirolimus|Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus. Patients were followed for 24 months post randomization
10962479|NCT00866905|BG000|Baseline|Arm/Group 1|All patients who received at least one dose of treatment.
10962480|NCT00866905|FG000|Participant Flow|Ixabepilone/Cyclophosphamide|"Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours~Cyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines"
10962481|NCT00866905|OG000|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
10962482|NCT00866905|OG000|Outcome|Ixabepilone/Cyclophosphamide|"Systemic Therapy followed by surgery and possible radiation therapy~Ixabepilone: 40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles~Cyclophosphamide: 600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles"
10962483|NCT00866905|OG000|Outcome|Ixabepilone/Cyclophosphamide|"Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours~Cyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines"
10962484|NCT00866905|EG000|Reported Event|Ixabepilone/Cyclophosphamide|All patients who received a dose of study treatment
10963927|NCT00875017|BG005|Baseline|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
11239658|NCT02472522|BG002|Baseline|Total|Total of all reporting groups
11239659|NCT02472522|FG000|Participant Flow|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
10962485|NCT00867009|BG000|Baseline|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
10962486|NCT00867009|FG000|Participant Flow|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
10962487|NCT00867009|OG000|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
10962488|NCT00867009|EG000|Reported Event|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
10962489|NCT00867035|BG000|Baseline|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
10962490|NCT00867035|BG001|Baseline|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
10962491|NCT00867035|BG002|Baseline|Total|Total of all reporting groups
10962492|NCT00867035|FG000|Participant Flow|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
10962493|NCT00867035|FG001|Participant Flow|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
10962494|NCT00867035|OG000|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
10962495|NCT00867035|OG001|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
11239660|NCT02472522|FG001|Participant Flow|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
10962496|NCT00867035|EG000|Reported Event|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
10962497|NCT00867035|EG001|Reported Event|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
10962498|NCT00867087|BG000|Baseline|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
10962499|NCT00867087|FG000|Participant Flow|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|Intravenous (IV) inotuzumab ozogamicin 1.8 milligrams per square meter (mg/m^2) given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
10962500|NCT00867087|OG000|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
10962501|NCT00867087|EG000|Reported Event|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
10962502|NCT00867100|BG000|Baseline|Placebo Part B|Single SC or IV dose of matching placebo
10962503|NCT00867100|BG001|Baseline|140 mg SC Part B|140 mg Sc PsO Population
10962504|NCT00867100|BG002|Baseline|350 mg SC Part B|350 mg Sc PsO population
10962505|NCT00867100|BG003|Baseline|700 mg IV Part B|700 mg IV PsO population
10962506|NCT00867100|BG004|Baseline|Placebo Part A|Single SC or IV dose of matching placebo
10962507|NCT00867100|BG005|Baseline|7mg SC Part A|7mg SC PsO population
10962508|NCT00867100|BG006|Baseline|21mg SC Part A|21mg SC PsO population
10962509|NCT00867100|BG007|Baseline|21mg IV Part A|21mg IV PsO population
11239661|NCT02472522|OG000|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
10962510|NCT00867100|BG008|Baseline|70mg SC Part A|70mg SC Pso population
10962511|NCT00867100|BG009|Baseline|210mg SC Part A|210mg SC PsO population
10962512|NCT00867100|BG010|Baseline|210mg IV Part A|210mg IV PsO population
10962513|NCT00867100|BG011|Baseline|420mg SC Part A|420mg SC PsO population
10962514|NCT00867100|BG012|Baseline|700mg IV Part A|700mg IV PsO population
10962515|NCT00867100|BG013|Baseline|Total|Total of all reporting groups
10962516|NCT00867100|FG000|Participant Flow|Placebo Part B|Single SC or IV dose of matching placebo
10962517|NCT00867100|FG001|Participant Flow|Cohort 10: 140 mg Sc Part B|"140 mg Sc PsO Population~Adults with Psoriasis"
11239662|NCT02472522|OG001|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
11239663|NCT02472522|OG000|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
11239664|NCT02472522|OG001|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
11239665|NCT02472522|EG000|Reported Event|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
11239666|NCT02472522|EG001|Reported Event|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
11239667|NCT02472652|BG000|Baseline|Abilify Maintena|"Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.~Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period"
11239668|NCT02472652|FG000|Participant Flow|Abilify Maintena|"Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.~Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period"
11239669|NCT02472652|OG000|Outcome|Abilify Maintena|"Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.~Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period"
11239670|NCT02472652|EG000|Reported Event|Abilify Maintena|"Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.~Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period"
11239671|NCT02472730|BG000|Baseline|Cap Assisted Colonoscopy|"The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm.~Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope."
11239672|NCT02472730|BG001|Baseline|Standard Colonoscopy|Standard colonoscopy without the distal attachment cap is performed in this arm.
11239673|NCT02472730|BG002|Baseline|Total|Total of all reporting groups
11361633|NCT02248740|FG000|Participant Flow|Radiofrequency Ablation|"Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.~Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment."
11361634|NCT02248740|FG001|Participant Flow|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.~Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment."
11361635|NCT02248740|OG000|Outcome|Radiofrequency Ablation|"Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.~Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment."
11361636|NCT02248740|OG001|Outcome|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.~Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment."
11361637|NCT02248740|EG000|Reported Event|Radiofrequency Ablation|"Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.~Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment."
11361638|NCT02248740|EG001|Reported Event|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.~Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment."
11361639|NCT02239627|BG000|Baseline|Steroid|"Epidural steroid injection~Epidural steroid"
11361640|NCT02239627|BG001|Baseline|Clonidine|"Epidural clonidine injection~Clonidine"
11361641|NCT02239627|BG002|Baseline|Total|Total of all reporting groups
11361642|NCT02239627|FG000|Participant Flow|Steroid|"Epidural steroid injection~Epidural steroid"
11361643|NCT02239627|FG001|Participant Flow|Clonidine|"Epidural clonidine injection~Clonidine"
11361644|NCT02239627|OG000|Outcome|Steroid|"Epidural steroid injection~Epidural steroid"
11361645|NCT02239627|OG001|Outcome|Clonidine|"Epidural clonidine injection~Clonidine"
11361646|NCT02239627|EG000|Reported Event|Steroid|"Epidural steroid injection~Epidural steroid"
11361647|NCT02239627|EG001|Reported Event|Clonidine|"Epidural clonidine injection~Clonidine"
11361648|NCT02244944|BG000|Baseline|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
11361649|NCT02244944|FG000|Participant Flow|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
11361650|NCT02244944|OG000|Outcome|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
11361651|NCT02244944|EG000|Reported Event|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
11361652|NCT02241187|BG000|Baseline|PEGPH20 And Cetuximab|"Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.~However, the two participants accrued to this study were healthy participants."
11377051|NCT00346164|OG002|Outcome|Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
10962518|NCT00867100|FG002|Participant Flow|Cohort 11: 350 mg Sc Part B|"350 mg Sc PsO population~Adults with Psoriasis"
11361653|NCT02241187|FG000|Participant Flow|PEGPH20 And Cetuximab|"5 participants will undergo DW- & DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) & (DCE)-MRI for repeatability investigation & T1 mapping. Optional DW- & DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- & DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- & DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.~PEGPH20~Cetuximab"
11361654|NCT02241187|OG000|Outcome|PEGPH20 And Cetuximab|"Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.~However, the two participants accrued to this study were healthy participants."
11361655|NCT02241187|EG000|Reported Event|PEGPH20 And Cetuximab|"Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.~All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were NOT monitored/assessed."
10962519|NCT00867100|FG003|Participant Flow|Cohort 9: 700 mg IV Part B|"700 mg IV PsO population~Adults with Psoriasis"
10962520|NCT00867100|FG004|Participant Flow|Placebo Part A|Single SC or IV dose of matching placebo
10962521|NCT00867100|FG005|Participant Flow|Cohort 1: 7mg SC Part A|7mg SC PsO population
10962522|NCT00867100|FG006|Participant Flow|Cohort 2: 21mg SC Part A|21mg SC PsO population
10962523|NCT00867100|FG007|Participant Flow|Cohort 3: 21mg IV Part A|21 mg IV PsO population
10962524|NCT00867100|FG008|Participant Flow|Cohort 4: 70mg SC Part A|70mg SC PsO population
10962525|NCT00867100|FG009|Participant Flow|Cohort 5: 210mg SC Part A|210mg SC PsO population
10962526|NCT00867100|FG010|Participant Flow|Cohort 6: 210mg IV Part A|210 mg IV PsO population
10962527|NCT00867100|FG011|Participant Flow|Cohort 7: 420mg SC Part A|420mg SC PsO Population
10962528|NCT00867100|FG012|Participant Flow|Cohort 8: 700mg IV Part A|700mg IV PsO population
10962529|NCT00867100|OG000|Outcome|Placebo|Placebo-treated
10962530|NCT00867100|OG001|Outcome|140 mg Sc|140 mg Sc PsO Population
11361656|NCT02239926|BG000|Baseline|Ranolazine|tablet, 1000 mg twice daily for four weeks
11361657|NCT02239926|BG001|Baseline|Placebo|Placebo
11361658|NCT02239926|BG002|Baseline|Total|Total of all reporting groups
11361659|NCT02239926|FG000|Participant Flow|Ranolazine|tablet, 1000 mg twice daily for four weeks
11361660|NCT02239926|FG001|Participant Flow|Placebo|Placebo
11361661|NCT02239926|OG000|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
10962531|NCT00867100|OG002|Outcome|350 mg Sc|350 mg Sc PsO population
10962532|NCT00867100|OG003|Outcome|700 mg IV|700 mg IV PsO population
10962533|NCT00867100|OG000|Outcome|Placebo Part B|Placebo-treated
10962534|NCT00867100|OG001|Outcome|140 mg Sc Part B|140 mg Sc PsO Population
11361662|NCT02239926|OG001|Outcome|Placebo|Placebo
10962535|NCT00867100|OG002|Outcome|350 mg Sc Part B|350 mg Sc PsO population
10962536|NCT00867100|OG003|Outcome|700 mg IV Part B|700 mg IV PsO population
10962537|NCT00867100|OG000|Outcome|Placebo Part A|Single SC or IV dose of matching placebo
10962538|NCT00867100|OG001|Outcome|Cohort 1: 7mg SC Part A|7mg SC PsO population
10962539|NCT00867100|OG002|Outcome|Cohort 2: 21mg SC Part A|21mg SC PsO population
10962540|NCT00867100|OG003|Outcome|Cohort 3: 21mg IV Part A|21 mg IV PsO population
10962541|NCT00867100|OG004|Outcome|Cohort 4: 70mg SC Part A|70mg SC PsO population
10962542|NCT00867100|OG005|Outcome|Cohort 5: 210mg SC Part A|210mg SC PsO population
10962543|NCT00867100|OG006|Outcome|Cohort 6: 210mg IV Part A|210 mg IV PsO population
10962544|NCT00867100|OG007|Outcome|Cohort 7: 420mg SC Part A|420mg SC PsO Population
10962545|NCT00867100|OG008|Outcome|Cohort 8: 700mg IV Part A|700mg IV PsO population
10962546|NCT00867100|EG000|Reported Event|Placebo Part B|Single SC or IV dose of matching placebo
10962547|NCT00867100|EG001|Reported Event|Cohort 10: 140 mg Sc Part B|140 mg Sc PsO Population
10962548|NCT00867100|EG002|Reported Event|Cohort 11: 350 mg Sc Part B|350 mg Sc PsO population
10962549|NCT00867100|EG003|Reported Event|Cohort 9: 700 mg IV Part B|700 mg IV PsO population
10962550|NCT00867100|EG004|Reported Event|Placebo Part A|Single SC or IV dose of matching placebo
10962551|NCT00867100|EG005|Reported Event|Cohort 1: 7mg SC Part A|7mg SC PsO population
10962552|NCT00867100|EG006|Reported Event|Cohort 2: 21mg SC Part A|21mg SC PsO population ...
10962553|NCT00867100|EG007|Reported Event|Cohort 3: 21mg IV Part A|21 mg IV PsO population ...
10962554|NCT00867100|EG008|Reported Event|Cohort 4: 70mg SC Part A|70mg SC PsO population ...
10962555|NCT00867100|EG009|Reported Event|Cohort 5: 210mg SC Part A|210mg SC PsO population ...
10962556|NCT00867100|EG010|Reported Event|Cohort 6: 210mg IV Part A|210 mg IV PsO population ...
10962557|NCT00867100|EG011|Reported Event|Cohort 7: 420mg SC Part A|420mg SC PsO Population ...
10962558|NCT00867100|EG012|Reported Event|Cohort 8: 700mg IV Part A|700mg IV PsO population ...
10962559|NCT00867113|BG000|Baseline|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
10962560|NCT00867113|FG000|Participant Flow|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
10962561|NCT00867113|OG000|Outcome|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
10962562|NCT00867113|EG000|Reported Event|Imatinib|Imatinib
10963928|NCT00875017|BG006|Baseline|Total|Total of all reporting groups
11361663|NCT02239926|EG000|Reported Event|Ranolazine|tablet, 1000 mg twice daily for four weeks
11361664|NCT02239926|EG001|Reported Event|Placebo|Placebo
11361665|NCT02231892|BG000|Baseline|Low Frequency rTMS - Behavioral Phase|Participants in this arm received sham or active 1Hz rTMS at 100% and 110% of motor threshold during the behavioral phase
10962563|NCT00867139|BG000|Baseline|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
10962564|NCT00867139|BG001|Baseline|Neuraminidase Inhibitor Monotheraphy|Neuraminidase inhibitors include zanamivir and oseltamivir phosphate in this study.
10962565|NCT00867139|BG002|Baseline|Open-Labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received open-label TCAD.
10962566|NCT00867139|BG003|Baseline|Total|Total of all reporting groups
10962567|NCT00867139|FG000|Participant Flow|TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
10962568|NCT00867139|FG001|Participant Flow|Neuraminidase Inhibitor Monotherapy|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
10962569|NCT00867139|FG002|Participant Flow|Open-labeled TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
10962570|NCT00867139|OG000|Outcome|TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
10962571|NCT00867139|OG001|Outcome|Neuraminidase Inihibitor Monotherapy|oseltamivir (50 mg); three times a day for 10 days
10962572|NCT00867139|OG002|Outcome|Open-labeled TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
11239674|NCT02472730|FG000|Participant Flow|Cap Assisted Colonoscopy|"The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm.~Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope."
11239675|NCT02472730|FG001|Participant Flow|Standard Colonoscopy|Standard colonoscopy without the distal attachment cap is performed in this arm.
10962573|NCT00867139|OG000|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
10962574|NCT00867139|OG001|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
10962575|NCT00867139|OG002|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
10962576|NCT00867139|OG000|Outcome|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
10962577|NCT00867139|OG001|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
10962578|NCT00867139|OG002|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
10962579|NCT00867139|OG000|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receiveTCAD or neuraminidase inhibitor monotherapy.
10962580|NCT00867139|OG002|Outcome|Open-lable TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
10962581|NCT00867139|EG000|Reported Event|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
10962582|NCT00867139|EG001|Reported Event|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
10962583|NCT00867139|EG002|Reported Event|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
10962584|NCT00867217|BG000|Baseline|Placebo|Placebo (3 capsules of matching placebo weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
10962585|NCT00867217|BG001|Baseline|Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
10962586|NCT00867217|BG002|Baseline|Total|Total of all reporting groups
10962587|NCT00867217|FG000|Participant Flow|Placebo|Placebo (3 capsules of matching placebo given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
10962588|NCT00867217|FG001|Participant Flow|Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
10962589|NCT00867217|OG000|Outcome|Placebo|Placebo (3 capsules of matching placebo) along with standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks
11361666|NCT02231892|BG001|Baseline|High Frequency rTMS - Behavioral Phase|Participants in this arm received sham or active 10Hz rTMS at 100% and 110% of motor threshold during the behavioral phase
11361667|NCT02231892|BG002|Baseline|High Frequency rTMS - MRI Phase|Participants in this arm received sham or active 10Hz rTMS at 100% and 110% of motor threshold during the MRI phase of the study.
11361668|NCT02231892|BG003|Baseline|Total|Total of all reporting groups
10962590|NCT00867217|OG001|Outcome|Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks
10962591|NCT00867217|EG000|Reported Event|Placebo|Placebo (3 capsules of matching placebo) along with standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks
10962592|NCT00867217|EG001|Reported Event|Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly
10962593|NCT00867308|BG000|Baseline|Lenalidomide 15 mg|"Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.~Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.~Patients without evidence of response after 4 cycles will be taken off-study."
10962594|NCT00867308|BG001|Baseline|Lenalidomide 50 mg|"Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.~Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.~Patients without evidence of response after 4 cycles will be taken off-study."
10962595|NCT00867308|BG002|Baseline|Total|Total of all reporting groups
10962596|NCT00867308|FG000|Participant Flow|Lenalidomide 15 mg|"Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.~Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.~Patients without evidence of response after 4 cycles will be taken off-study."
11361669|NCT02231892|FG000|Participant Flow|Low Frequency rTMS - Behavioral Phase|Participants in this arm received sham or active 1 hertz (Hz) rTMS at 100% and 110% of motor threshold during the behavioral phase.
10962597|NCT00867308|FG001|Participant Flow|Lenalidomide 50 mg|"Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.~Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.~Patients without evidence of response after 4 cycles will be taken off-study."
10962598|NCT00867308|OG000|Outcome|Lenalidomide 15 mg|"Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.~Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.~Patients without evidence of response after 4 cycles will be taken off-study."
10962599|NCT00867308|OG001|Outcome|Lenalidomide 50 mg|"Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.~Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.~Patients without evidence of response after 4 cycles will be taken off-study."
10962600|NCT00867308|EG000|Reported Event|Lenalidomide 15 mg|"Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.~Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.~Patients without evidence of response after 4 cycles will be taken off-study."
10963929|NCT00875017|FG000|Participant Flow|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
11361670|NCT02231892|FG001|Participant Flow|High Frequency rTMS - Behavioral Phase|Participants in this arm received sham or active 10 hertz (Hz) rTMS at 100% and 110% of motor threshold during the behavioral phase
11361671|NCT02231892|FG002|Participant Flow|High Frequency rTMS - MRI Phase|Participants in this arm received sham or active 10 hertz (Hz) rTMS at 100% and 110% of motor threshold during the MRI phase of the study.
11361672|NCT02231892|OG000|Outcome|Low Frequency rTMS - Behavioral Phase|Participants in this arm received sham or active 1Hz rTMS at 100% and 110% of motor threshold during the behavioral phase
11361673|NCT02231892|OG001|Outcome|High Frequency rTMS - Behavioral Phase|Participants in this arm received sham or active 10Hz rTMS at 100% and 110% of motor threshold during the behavioral phase
11361674|NCT02231892|OG002|Outcome|High Frequency rTMS - MRI Phase|Participants in this arm received sham or active 10Hz rTMS at 100% and 110% of motor threshold during the MRI phase of the study.
11361675|NCT02231892|EG000|Reported Event|Low Frequency rTMS - 100% MT - Behavioral Phase|Active 1Hz rTMS at 100% of motor threshold during the behavioral phase
11361676|NCT02231892|EG001|Reported Event|Low Frequency rTMS - 110% MT - Behavioral Phase|Active 1Hz rTMS at 110% of motor threshold during the behavioral phase
11361677|NCT02231892|EG002|Reported Event|Low Frequency rTMS - Sham - Behavioral Phase|Low Frequency rTMS, sham, during behavioral phase.
11361678|NCT02231892|EG003|Reported Event|High Frequency rTMS - 100% MT - Behavioral Phase|Active 10Hz rTMS at 100% of motor threshold during the behavioral phase
11361679|NCT02231892|EG004|Reported Event|High Frequency rTMS - 110% MT - Behavioral Phase|Active 10Hz rTMS at 110% of motor threshold during the behavioral phase
11361680|NCT02231892|EG005|Reported Event|High Frequency rTMS - Sham - Behavioral Phase|High Frequency rTMS, sham, during behavioral phase.
11361681|NCT02231892|EG006|Reported Event|High Frequency rTMS - 100% MT - MRI Phase|Active 10Hz rTMS at 100% of motor threshold during the MRI phase of the study.
11361682|NCT02231892|EG007|Reported Event|High Frequency rTMS - 110% MT - MRI Phase|Active 10Hz rTMS at 110% of motor threshold during the MRI phase of the study.
11361683|NCT02231892|EG008|Reported Event|High Frequency rTMS - Sham - MRI Phase|High Frequency rTMS, sham, during MRI phase.
11361684|NCT02241343|BG000|Baseline|Trial Cohort|All participants
11361685|NCT02241343|FG000|Participant Flow|Trial Cohort|All participants
11361686|NCT02241343|OG000|Outcome|Trial Cohort|All participants
11361687|NCT02241343|OG000|Outcome|Trial Cohort|"Measurements taken before and after venous occlusion applied~Venous occlusion (leg tourniquet, made in-house): Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound"
11361688|NCT02241343|EG000|Reported Event|Trial Cohort|
11361689|NCT02242578|BG000|Baseline|Active|"Active rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)~1 Hz rTMS: About 1,000 stimulation pulses over 20 min~10 Hz rTMS: About 1,000 stimulation pulses over 20 min"
11361690|NCT02242578|BG001|Baseline|Placebo|"Sham rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)~1 Hz rTMS: About 1,000 stimulation pulses over 20 min~10 Hz rTMS: About 1,000 stimulation pulses over 20 min"
11361691|NCT02242578|BG002|Baseline|Total|Total of all reporting groups
11361692|NCT02242578|FG000|Participant Flow|Active|"Active rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)~1 Hz rTMS: About 1,000 stimulation pulses over 20 min~10 Hz rTMS: About 1,000 stimulation pulses over 20 min"
11361693|NCT02242578|FG001|Participant Flow|Placebo|"Sham rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)~1 Hz rTMS: About 1,000 stimulation pulses over 20 min~10 Hz rTMS: About 1,000 stimulation pulses over 20 min"
11361694|NCT02242578|OG000|Outcome|Active|"Active rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)~1 Hz rTMS: About 1,000 stimulation pulses over 20 min~10 Hz rTMS: About 1,000 stimulation pulses over 20 min"
11361695|NCT02242578|OG001|Outcome|Placebo|"Sham rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)~1 Hz rTMS: About 1,000 stimulation pulses over 20 min~10 Hz rTMS: About 1,000 stimulation pulses over 20 min"
11361696|NCT02242578|EG000|Reported Event|Active|"Active rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)~1 Hz rTMS: About 1,000 stimulation pulses over 20 min~10 Hz rTMS: About 1,000 stimulation pulses over 20 min"
11361697|NCT02242578|EG001|Reported Event|Placebo|"Sham rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)~1 Hz rTMS: About 1,000 stimulation pulses over 20 min~10 Hz rTMS: About 1,000 stimulation pulses over 20 min"
11361698|NCT02234011|BG000|Baseline|Treatment|No participants enrolled in treatment portion of study, and therefore never completed a baseline visit. One subject completed a screening visit and then withdrew from study due to time commitments.
11361699|NCT02234011|FG000|Participant Flow|Treatment|No participants enrolled in treatment portion of study.
11361700|NCT02234011|OG000|Outcome|Treatment|No participants enrolled in treatment portion of study.
11361701|NCT02234011|EG000|Reported Event|Treatment|"No participants enrolled in treatment portion of study. One subject had a screening visit, but since she never entered the treatment portion of the study and never received the study medication. Because she never had any exposure to the study medication and had no visits other than the initial screening visit, she was never at risk for any adverse events related to study medication.~No adverse events related to study medication were collected since no subjects ever entered the treatment phase of this study."
11361702|NCT02236546|BG000|Baseline|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
11361703|NCT02236546|FG000|Participant Flow|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
11361704|NCT02236546|OG000|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
11361705|NCT02236546|EG000|Reported Event|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
11361706|NCT02234687|BG000|Baseline|Placebo|
11361707|NCT02234687|BG001|Baseline|40 mg Poma|
11361708|NCT02234687|BG002|Baseline|160 mg Poma|
11361709|NCT02234687|BG003|Baseline|Total|Total of all reporting groups
11361710|NCT02234687|FG000|Participant Flow|40 mg Poma|Study Terminated. No outcome measures were analyzed
11361711|NCT02234687|FG001|Participant Flow|Placebo|Study Terminated. No outcome measures were analyzed
11361712|NCT02234687|FG002|Participant Flow|160 mg Poma|Study Terminated. No outcome measures were analyzed
11361713|NCT02234687|OG000|Outcome|Placebo|Placebo: Placebo, one dose, one time
11361714|NCT02234687|OG001|Outcome|Pomaglumetad Methionil 160mg|Pomaglumetad Methionil 160mg, one dose, one time Pomaglumetad Methionil 160mg: Pomaglumetad Methionil 160mg, one dose, one time
11361715|NCT02234687|OG002|Outcome|Pomaglumetad Methionil 40mg|Pomaglumetad Methionil 40mg, one dose, one time Pomaglumetad Methionil 40mg: Pomaglumetad Methionil 40mg, one dose, one time
11361716|NCT02234687|EG000|Reported Event|Placebo|Placebo, one dose Placebo: Placebo, one dose, one time
11361717|NCT02234687|EG001|Reported Event|Pomaglumetad Methionil 160mg|Pomaglumetad Methionil 160mg, one dose, one time
11361718|NCT02234687|EG002|Reported Event|Pomaglumetad Methionil 40mg|Pomaglumetad Methionil 40mg, one dose, one time
11361719|NCT02224599|BG000|Baseline|CYP, TAPA-pulsed DC Vaccine, Imiquimod|"TAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream~TAPA-pulsed DC vaccine: Subjects will given the vaccine which contains 1 x 10^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly.~Cyclophosphamide Pill: Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle.~Imiquimod Topical Cream: Topical Imiquimod Cream will be applied after vaccination."
10962601|NCT00867308|EG001|Reported Event|Lenalidomide 50 mg|"Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.~Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.~Patients without evidence of response after 4 cycles will be taken off-study."
11361720|NCT02224599|FG000|Participant Flow|CYP, TAPA-pulsed DC Vaccine, Imiquimod|"TAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream~TAPA-pulsed DC vaccine: Subjects will given the vaccine which contains 1 x 10^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly.~Cyclophosphamide Pill: Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle.~Imiquimod Topical Cream: Topical Imiquimod Cream will be applied after vaccination."
11361721|NCT02224599|OG000|Outcome|CYP, TAPA-pulsed DC Vaccine, Imiquimod|"TAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream~TAPA-pulsed DC vaccine: Subjects will given the vaccine which contains 1 x 10^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly.~Cyclophosphamide Pill: Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle.~Imiquimod Topical Cream: Topical Imiquimod Cream will be applied after vaccination."
11361722|NCT02224599|EG000|Reported Event|CYP, TAPA-pulsed DC Vaccine, Imiquimod|"TAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream~TAPA-pulsed DC vaccine: Subjects will given the vaccine which contains 1 x 10^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly.~Cyclophosphamide Pill: Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle.~Imiquimod Topical Cream: Topical Imiquimod Cream will be applied after vaccination."
11361723|NCT02201472|BG000|Baseline|MRI With MRE|"Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device~MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device"
11361724|NCT02201472|FG000|Participant Flow|MRI With MRE|"Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device~MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device"
11361725|NCT02201472|OG000|Outcome|MRI With MRE|"Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device~MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device"
11361726|NCT02201472|EG000|Reported Event|MRI With MRE|"Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device~MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device"
11361727|NCT02202044|BG000|Baseline|Intravesical BCG and EMDA/MMC|"Patients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC~Intravesical BCG and EMDA/MMC: Patients are assigned one course of treatment per week for 6 weeks with sequential 'Intravesical instillation of sequential Bacillus Calmette-Guérin (BCG) and Electromotive Drug Administration /Mitomycin-C"
11361728|NCT02202044|FG000|Participant Flow|Intravesical BCG and EMDA/MMC|"Patients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC~Intravesical BCG and EMDA/MMC: Patients are assigned one course of treatment per week for 6 weeks with sequential 'Intravesical instillation of sequential Bacillus Calmette-Guérin (BCG) and Electromotive Drug Administration /Mitomycin-C"
11361729|NCT02202044|OG000|Outcome|Intravesical BCG and EMDA/MMC|"Patients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC~Intravesical BCG and EMDA/MMC: Patients are assigned one course of treatment per week for 6 weeks with sequential 'Intravesical instillation of sequential Bacillus Calmette-Guérin (BCG) and Electromotive Drug Administration /Mitomycin-C"
11361730|NCT02202044|EG000|Reported Event|Intravesical BCG and EMDA/MMC|"Patients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC~Intravesical BCG and EMDA/MMC: Patients are assigned one course of treatment per week for 6 weeks with sequential 'Intravesical instillation of sequential Bacillus Calmette-Guérin (BCG) and Electromotive Drug Administration /Mitomycin-C"
11361731|NCT02192775|BG000|Baseline|MV-NIS + Cyclophosphamide|MV-NIS: one dose in conjunction with a 4 day course intravenously
11361732|NCT02192775|FG000|Participant Flow|MV-NIS + Cyclophosphamide|MV-NIS: one dose in conjunction with a 4 day course intravenously
11361733|NCT02192775|OG000|Outcome|MV-NIS + Cyclophosphamide|MV-NIS: one dose in conjunction with a 4 day course intravenously
11361734|NCT02192775|EG000|Reported Event|MV-NIS + Cyclophosphamide|MV-NIS: one dose in conjunction with a 4 day course intravenously
11361735|NCT02200328|BG000|Baseline|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
11361736|NCT02200328|BG001|Baseline|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
11361737|NCT02200328|BG002|Baseline|Total|Total of all reporting groups
11361738|NCT02200328|FG000|Participant Flow|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
11361739|NCT02200328|FG001|Participant Flow|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
11361740|NCT02200328|OG000|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
11361741|NCT02200328|OG001|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
11361742|NCT02200328|EG000|Reported Event|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
11361743|NCT02200328|EG001|Reported Event|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
11361744|NCT02200042|BG000|Baseline|Radiation Therapy|"Liver-directed radiation therapy~Radiation Therapy: Patients undergo 15 fractions of image-guided radiation therapy delivered over 19-26 or 27-34 days."
11361745|NCT02200042|BG001|Baseline|Observation|No radiation therapy
11361746|NCT02200042|BG002|Baseline|Total|Total of all reporting groups
11361747|NCT02200042|FG000|Participant Flow|Radiation Therapy|"Liver-directed radiation therapy~Radiation Therapy: Patients undergo 15 fractions of image-guided radiation therapy delivered over 19-26 or 27-34 days."
11361748|NCT02200042|FG001|Participant Flow|Observation|No radiation therapy
11361749|NCT02200042|OG000|Outcome|Radiation Therapy|"Liver-directed radiation therapy~Radiation Therapy: Patients undergo 15 fractions of image-guided radiation therapy delivered over 19-26 or 27-34 days."
11361750|NCT02200042|OG001|Outcome|Observation|No radiation therapy
11361751|NCT02200042|EG000|Reported Event|Radiation Therapy|"Liver-directed radiation therapy~Radiation Therapy: Patients undergo 15 fractions of image-guided radiation therapy delivered over 19-26 or 27-34 days."
11361752|NCT02200042|EG001|Reported Event|Observation|No radiation therapy
11361753|NCT02181790|BG000|Baseline|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361754|NCT02181790|BG001|Baseline|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361755|NCT02181790|BG002|Baseline|Total|Total of all reporting groups
11361756|NCT02181790|FG000|Participant Flow|Excimer Laser (One Palm/Sole)|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361757|NCT02181790|FG001|Participant Flow|Excimer Laser (Both Palms/Soles)|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361758|NCT02181790|OG000|Outcome|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361759|NCT02181790|OG001|Outcome|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361760|NCT02181790|OG000|Outcome|Excimer Laser (One Palm/Sole)|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361761|NCT02181790|OG001|Outcome|Excimer Laser (Both Palms/Soles)|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361762|NCT02181790|EG000|Reported Event|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361763|NCT02181790|EG001|Reported Event|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
11361764|NCT02198833|BG000|Baseline|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
10962602|NCT00867334|BG000|Baseline|Treatment With Increasing Doses of Imatinib|"Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.~All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab."
10962603|NCT00867334|BG001|Baseline|Standard of Care Therapy With Panitumumab|Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
10962604|NCT00867334|BG002|Baseline|Total|Total of all reporting groups
10962605|NCT00867334|FG000|Participant Flow|Treatment With Increasing Doses of Imatinib|"Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.~All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab."
10962606|NCT00867334|FG001|Participant Flow|Standard of Care Therapy With Panitumumab|Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
10962607|NCT00867334|OG000|Outcome|Treatment With Increasing Doses of Imatinib|"Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.~All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab."
10962608|NCT00867334|OG001|Outcome|Standard of Care Therapy With Panitumumab|Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
10962609|NCT00867334|EG000|Reported Event|Treatment With Increasing Doses of Imatinib|"Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.~All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab."
10962610|NCT00867334|EG001|Reported Event|Standard of Care Therapy With Panitumumab|Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
11361765|NCT02198833|BG001|Baseline|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
11361766|NCT02198833|BG002|Baseline|Total|Total of all reporting groups
10962611|NCT00867360|BG000|Baseline|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
10962612|NCT00867360|BG001|Baseline|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
10962613|NCT00867360|BG002|Baseline|Total|Total of all reporting groups
10962614|NCT00867360|FG000|Participant Flow|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
10962615|NCT00867360|FG001|Participant Flow|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
10962616|NCT00867360|OG000|Outcome|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
10962617|NCT00867360|OG001|Outcome|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
10962618|NCT00867360|OG000|Outcome|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
10962619|NCT00867360|EG000|Reported Event|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
10962620|NCT00867360|EG001|Reported Event|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
10962621|NCT00867451|BG000|Baseline|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
10962622|NCT00867451|BG001|Baseline|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
10962623|NCT00867451|BG002|Baseline|Total|Total of all reporting groups
10962624|NCT00867451|FG000|Participant Flow|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
10963930|NCT00875017|FG001|Participant Flow|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
11361767|NCT02198833|FG000|Participant Flow|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
11361768|NCT02198833|FG001|Participant Flow|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
11361769|NCT02198833|OG000|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
11361770|NCT02198833|OG001|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
11361771|NCT02198833|EG000|Reported Event|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
11361772|NCT02198833|EG001|Reported Event|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
11361773|NCT02175628|BG000|Baseline|Acoustic Angiography|"All breast patients will be included in the experimental group.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
11361774|NCT02175628|BG001|Baseline|Healthy Volunteers|"A volunteer group was added to the study to perfect the image acquisition techniques.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
11361775|NCT02175628|BG002|Baseline|Total|Total of all reporting groups
11361776|NCT02175628|FG000|Participant Flow|Acoustic Angiography|"All breast patients will be included in the experimental group.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
11361777|NCT02175628|FG001|Participant Flow|Healthy Volunteers|"A volunteer group was added to the study to perfect the image acquisition techniques.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
11361778|NCT02175628|OG000|Outcome|Acoustic Angiography|"All breast patients will be included in the experimental group.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
11361779|NCT02175628|OG001|Outcome|Healthy Volunteers|"A volunteer group was added to the study to perfect the image acquisition techniques.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
11361780|NCT02175628|EG000|Reported Event|Acoustic Angiography|"All breast patients will be included in the experimental group.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
11361781|NCT02175628|EG001|Reported Event|Healthy Volunteers|"A volunteer group was added to the study to perfect the image acquisition techniques.~Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
11361782|NCT02177266|BG000|Baseline|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
11361783|NCT02177266|BG001|Baseline|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
11361784|NCT02177266|BG002|Baseline|Total|Total of all reporting groups
11361785|NCT02177266|FG000|Participant Flow|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
11361786|NCT02177266|FG001|Participant Flow|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
11361787|NCT02177266|OG000|Outcome|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
11361788|NCT02177266|OG001|Outcome|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
11361789|NCT02177266|EG000|Reported Event|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
10963931|NCT00875017|FG002|Participant Flow|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
11361790|NCT02177266|EG001|Reported Event|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
11361791|NCT02184520|BG000|Baseline|TRANSITION|"Stabilization System~TRANSITION"
11361792|NCT02184520|BG001|Baseline|REVERE|"Stabilization System~REVERE"
11361793|NCT02184520|BG002|Baseline|Total|Total of all reporting groups
11361794|NCT02184520|FG000|Participant Flow|TRANSITION|"Stabilization System~TRANSITION"
11361795|NCT02184520|FG001|Participant Flow|REVERE|"Stabilization System~REVERE"
11361796|NCT02184520|OG000|Outcome|TRANSITION|"Stabilization System~TRANSITION"
11361797|NCT02184520|OG001|Outcome|REVERE|"Stabilization System~REVERE"
11361798|NCT02184520|EG000|Reported Event|TRANSITION|Stabilization System
11361799|NCT02184520|EG001|Reported Event|REVERE|Stabilization System
11361800|NCT02170298|BG000|Baseline|Placebo|"Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.~Drug: Placebo~Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments."
11361801|NCT02170298|BG001|Baseline|Lisdexamfetamine|"Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.~Drug: Lisdexamfetamine~Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments."
11361802|NCT02170298|BG002|Baseline|Total|Total of all reporting groups
11361803|NCT02170298|FG000|Participant Flow|Placebo|"Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.~Drug: Placebo~Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments."
11361804|NCT02170298|FG001|Participant Flow|Lisdexamfetamine|"Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.~Drug: Lisdexamfetamine~Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments."
11361805|NCT02170298|OG000|Outcome|Placebo|"Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.~Drug: Placebo~Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments."
11361806|NCT02170298|OG001|Outcome|Lisdexamfetamine|"Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.~Drug: Lisdexamfetamine~Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments."
11361807|NCT02170298|EG000|Reported Event|Placebo|"Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.~Drug: Placebo~Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments."
11361808|NCT02170298|EG001|Reported Event|Lisdexamfetamine|"Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.~Drug: Lisdexamfetamine~Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments."
11361809|NCT02177773|BG000|Baseline|Ga-68 DOTA-TOC PET/CT|"Patients receive gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.~Computed Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT~Gallium Ga 68-Edotreotide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Magnetic Resonance Imaging: Undergo gallium Ga 68-DOTA-TOC PET/MRI~Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT~Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/MRI"
11361810|NCT02177773|FG000|Participant Flow|DOTATOC Imaging|All patients received a single DOTATOC imaging study.
11361811|NCT02177773|OG000|Outcome|DOTATOC Imaging|All patients received a single DOTATOC imaging study.
11361812|NCT02177773|EG000|Reported Event|DOTATOC Imaging|All patients received a single DOTATOC imaging study.
11361813|NCT02162979|BG000|Baseline|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
11361814|NCT02162979|BG001|Baseline|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
11361815|NCT02162979|BG002|Baseline|Total|Total of all reporting groups
11361816|NCT02162979|FG000|Participant Flow|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
11361817|NCT02162979|FG001|Participant Flow|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
11361818|NCT02162979|OG000|Outcome|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
11361819|NCT02162979|OG001|Outcome|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
11361820|NCT02162979|EG000|Reported Event|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
11361821|NCT02162979|EG001|Reported Event|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
10963932|NCT00875017|FG003|Participant Flow|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
11361822|NCT02169830|BG000|Baseline|Nortriptyline|"Diet modification - nortriptyline and then if necessary topiramate~nortriptyline: The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication."
11361823|NCT02169830|BG001|Baseline|Topiramate|"Diet Modification topiramate and then nortriptyline if necessary~Topiramate: Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID"
11361824|NCT02169830|BG002|Baseline|Diet Modification|Emphasis will be given to cessation of known migraine triggers such as caffeine, sodas, chocolates, alcohol (especially red wine) and aged cheeses. Patients who have complete control of their symptoms with diet and behavior modification alone will be followed for a total of 4 months to determine the durability of symptom relief.
11361825|NCT02169830|BG003|Baseline|Total|Total of all reporting groups
11361826|NCT02169830|FG000|Participant Flow|Nortriptyline|"Diet modification - nortriptyline and then if necessary topiramate~nortriptyline: The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication."
11361827|NCT02169830|FG001|Participant Flow|Topiramate|"Diet Modification topiramate and then nortriptyline if necessary~Topiramate: Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID"
11361828|NCT02169830|FG002|Participant Flow|Diet Modification|Emphasis will be given to cessation of known migraine triggers such as caffeine, sodas, chocolates, alcohol (especially red wine) and aged cheeses. Patients who have complete control of their symptoms with diet and behavior modification alone will be followed for a total of 4 months to determine the durability of symptom relief.
11361829|NCT02169830|OG000|Outcome|Nortriptyline|"Diet modification - nortriptyline and then if necessary topiramate~nortriptyline: The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication."
11361830|NCT02169830|OG001|Outcome|Topiramate|"Diet Modification topiramate and then nortriptyline if necessary~Topiramate: Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID"
11361831|NCT02169830|OG002|Outcome|Diet Modification|Emphasis will be given to cessation of known migraine triggers such as caffeine, sodas, chocolates, alcohol (especially red wine) and aged cheeses. Patients who have complete control of their symptoms with diet and behavior modification alone will be followed for a total of 4 months to determine the durability of symptom relief.
11361832|NCT02169830|EG000|Reported Event|Nortriptyline|"Diet modification - nortriptyline and then if necessary topiramate~nortriptyline: The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication."
11361833|NCT02169830|EG001|Reported Event|Topiramate|"Diet Modification topiramate and then nortriptyline if necessary~Topiramate: Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID"
11361834|NCT02169830|EG002|Reported Event|Diet Modification|Emphasis will be given to cessation of known migraine triggers such as caffeine, sodas, chocolates, alcohol (especially red wine) and aged cheeses. Patients who have complete control of their symptoms with diet and behavior modification alone will be followed for a total of 4 months to determine the durability of symptom relief.
11361835|NCT02163187|BG000|Baseline|InterStimTM the Device on, Then InterStim TM the Device Off|The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.
11361836|NCT02163187|BG001|Baseline|InterStimTM the Device Off, Then InterStim the Device on|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~No participants were accrued to this arm before the study was closed."
11361837|NCT02163187|BG002|Baseline|Total|Total of all reporting groups
11361838|NCT02163187|FG000|Participant Flow|InterStimTM the Device on, Then InterStimTM Device Off|"The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
11361839|NCT02163187|FG001|Participant Flow|InterStimTM the Device Off, Then InterStimTM Device on|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
11361840|NCT02163187|OG000|Outcome|InterStimTM the Device on|"The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
11361841|NCT02163187|OG001|Outcome|InterStimTM the Device Off|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
11361842|NCT02163187|EG000|Reported Event|InterStimTM the Device on|"The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
10963933|NCT00875017|FG004|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
11239676|NCT02472730|OG000|Outcome|Cap Assisted Colonoscopy|"The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm.~Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope."
11239677|NCT02472730|OG001|Outcome|Standard Colonoscopy|Standard colonoscopy without the distal attachment cap is performed in this arm.
11239678|NCT02472730|EG000|Reported Event|Cap Assisted Colonoscopy|"The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm.~Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope."
11239679|NCT02472730|EG001|Reported Event|Standard Colonoscopy|Standard colonoscopy without the distal attachment cap is performed in this arm.
11239680|NCT02472756|BG000|Baseline|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
11239681|NCT02472756|FG000|Participant Flow|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
11239682|NCT02472756|OG000|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
11239683|NCT02472756|EG000|Reported Event|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
11239684|NCT02472795|BG000|Baseline|Cenerimod 0.5 mg (Part A)|Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
11239685|NCT02472795|BG001|Baseline|Cenerimod 1 mg (Part A)|Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
11239686|NCT02472795|BG002|Baseline|Cenerimod 2 mg (Part A)|Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
11239687|NCT02472795|BG003|Baseline|Cenerimod 4 mg (Part B)|Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
11239688|NCT02472795|BG004|Baseline|Matching Placebo (Part A and Part B)|Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
11239689|NCT02472795|BG005|Baseline|Total|Total of all reporting groups
11239690|NCT02472795|FG000|Participant Flow|Cenerimod 0.5 mg (Part A)|Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
11239691|NCT02472795|FG001|Participant Flow|Cenerimod 1 mg (Part A)|Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
11239692|NCT02472795|FG002|Participant Flow|Cenerimod 2 mg (Part A)|Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
11239693|NCT02472795|FG003|Participant Flow|Cenerimod 4 mg (Part B)|Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
11239694|NCT02472795|FG004|Participant Flow|Matching Placebo (Part A and B)|Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
11239695|NCT02472795|OG000|Outcome|Cenerimod 0.5 mg (Part A)|Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
11239696|NCT02472795|OG001|Outcome|Cenerimod 1 mg (Part A)|Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
11361843|NCT02163187|EG001|Reported Event|InterStimTM the Device Off|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
11239697|NCT02472795|OG002|Outcome|Cenerimod 2 mg (Part A)|Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
11239698|NCT02472795|OG003|Outcome|Cenerimod 4 mg (Part B)|Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
11239699|NCT02472795|OG004|Outcome|Matching Placebo|Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
11239700|NCT02472795|EG000|Reported Event|Cenerimod 0.5 mg|Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.
11239701|NCT02472795|EG001|Reported Event|Cenerimod 1 mg|Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
11239702|NCT02472795|EG002|Reported Event|Cenerimod 2 mg|Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.
11239703|NCT02472795|EG003|Reported Event|Cenerimod 4 mg|Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.
11239704|NCT02472795|EG004|Reported Event|Matching Placebo|Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
10962625|NCT00867451|FG001|Participant Flow|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
10962626|NCT00867451|OG000|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
10962627|NCT00867451|OG001|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
10962628|NCT00867451|OG000|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
11188400|NCT02113189|OG002|Outcome|Walking Program With Custom Braces|This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program. Walking program with custom braces: walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom ankle braces on.
11361844|NCT02161016|BG000|Baseline|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
10962629|NCT00867451|OG001|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
10962630|NCT00867451|OG000|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
10962631|NCT00867451|OG001|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
10963934|NCT00875017|FG005|Participant Flow|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
11188401|NCT02113189|EG000|Reported Event|Walking Program With Ankle Brace|"This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.~Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on."
11188402|NCT02113189|EG001|Reported Event|Individualized Walking Program|"This group will receive a customized walking program.~Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking"
11188403|NCT02113189|EG002|Reported Event|Walking Program With Custom Braces|"This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.~Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on."
11188404|NCT02113241|BG000|Baseline|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.~Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days."
11188405|NCT02113241|BG001|Baseline|Placebo|"Placebo capsules, 10 mg, one per day before breakfast during 90 days.~Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days."
11188406|NCT02113241|BG002|Baseline|Total|Total of all reporting groups
11188407|NCT02113241|FG000|Participant Flow|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.~Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days."
11188408|NCT02113241|FG001|Participant Flow|Placebo|"Placebo capsules, 10 mg, one per day before breakfast during 90 days.~Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days."
11188409|NCT02113241|OG000|Outcome|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.~Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days."
11188410|NCT02113241|OG001|Outcome|Placebo|"Placebo capsules, 10 mg, one per day before breakfast during 90 days.~Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days."
11188411|NCT02113241|EG000|Reported Event|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.~Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days."
11188412|NCT02113241|EG001|Reported Event|Placebo|"Placebo capsules, 10 mg, one per day before breakfast during 90 days.~Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days."
11188413|NCT02113410|BG000|Baseline|Sit N Fit Chair Yoga|"The chair yoga intervention consisted of twice-weekly 45-minute sessions incorporating four components-physical postures, breathing, deep relaxation, and meditation-while using the support of a chair. The yoga instructor at each site was certified by the Yoga Alliance and spent two 8-hour days being trained on the Sit N Fit Chair Yoga program by the program developer."
11188414|NCT02113410|BG001|Baseline|Health Education Program|To control for attention and time, HEP participants attended twice-weekly 45-minute sessions for 8 weeks led by health care providers trained by the principal investigators. The instructors received two 4-hour days being trained on HEP teaching instructions and serving as an arbitrator of any disagreements between participants on a certain topic. HEP participants discussed general health education information and specific facts regarding OA; they did not participate in any form of yoga.
11188415|NCT02113410|BG002|Baseline|Total|Total of all reporting groups
11188416|NCT02113410|FG000|Participant Flow|Health Education Program (HEP)|To control for attention and time, HEP participants attended twice-weekly 45-minute sessions for 8 weeks led by health care providers trained by the principal investigators. The instructors received two 4-hour days being trained on HEP teaching instructions and serving as an arbitrator of any disagreements between participants on a certain topic. HEP participants discussed general health education information and specific facts regarding OA; they did not participate in any form of yoga.
11188417|NCT02113410|FG001|Participant Flow|Sit 'N' Fit Chair Yoga|"The chair yoga intervention consisted of twice-weekly 45-minute sessions incorporating four components-physical postures, breathing, deep relaxation, and meditation-while using the support of a chair. The yoga instructor at each site was certified by the Yoga Alliance and spent two 8-hour days being trained on the Sit N Fit Chair Yoga program by the program developer."
10963935|NCT00875017|OG000|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
11239705|NCT02472847|BG000|Baseline|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
11239706|NCT02472847|BG001|Baseline|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
11239707|NCT02472847|BG002|Baseline|Total|Total of all reporting groups
11239708|NCT02472847|FG000|Participant Flow|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
11239709|NCT02472847|FG001|Participant Flow|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
11239710|NCT02472847|OG000|Outcome|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
11239711|NCT02472847|OG001|Outcome|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
11239712|NCT02472847|EG000|Reported Event|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
11239713|NCT02472847|EG001|Reported Event|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
11239714|NCT02472886|BG000|Baseline|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF(90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
11239715|NCT02472886|BG001|Baseline|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
11239716|NCT02472886|BG002|Baseline|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
11239717|NCT02472886|BG003|Baseline|Total|Total of all reporting groups
11239718|NCT02472886|FG000|Participant Flow|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
11239719|NCT02472886|FG001|Participant Flow|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
11239720|NCT02472886|FG002|Participant Flow|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study
11361845|NCT02161016|FG000|Participant Flow|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
11361846|NCT02161016|OG000|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
11361847|NCT02161016|EG000|Reported Event|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
11361848|NCT02159040|BG000|Baseline|Azacitidine|75mg/m2 7days/28 day cycle
11361849|NCT02159040|FG000|Participant Flow|Azacitidine|75mg/m2 7days/28 day cycle
11361850|NCT02159040|OG000|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
11361851|NCT02159040|EG000|Reported Event|Azacitidine|75mg/m2 7days/28 day cycle
11361852|NCT02168270|BG000|Baseline|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11361853|NCT02168270|FG000|Participant Flow|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11361854|NCT02168270|OG000|Outcome|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11361855|NCT02168270|EG000|Reported Event|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
11361856|NCT02157116|BG000|Baseline|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
11361857|NCT02157116|FG000|Participant Flow|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
11361858|NCT02157116|OG000|Outcome|Treated Patients|
11361859|NCT02157116|EG000|Reported Event|Treated Patients|Due to insufficient accrual, adverse event data was not analyzed.
11361860|NCT02154087|BG000|Baseline|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
11361861|NCT02154087|FG000|Participant Flow|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
11361862|NCT02154087|OG000|Outcome|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
11361863|NCT02154087|EG000|Reported Event|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
10962632|NCT00867451|EG000|Reported Event|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
11361864|NCT02152670|BG000|Baseline|Enrolled and Randomized|This summarizes the single patient enrolled and randomized to the study.
11361865|NCT02152670|FG000|Participant Flow|Enrolled and Randomized|This summarizes the single patient enrolled and randomized to the study.
11361866|NCT02152670|OG000|Outcome|Enrolled and Randomized|This summarizes the single patient enrolled and randomized to the study.
11361867|NCT02152670|EG000|Reported Event|Enrolled and Randomized|This summarizes the single patient enrolled and randomized to the study.
11361868|NCT02152566|BG000|Baseline|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
11361869|NCT02152566|FG000|Participant Flow|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
11361870|NCT02152566|OG000|Outcome|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
11361871|NCT02152566|EG000|Reported Event|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
11361872|NCT02137096|BG000|Baseline|High Dose Conditioning|"Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation~Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase~Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase.~Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase~Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm."
11361873|NCT02137096|FG000|Participant Flow|High Dose Conditioning|"Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation~Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase~Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase.~Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase~Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm."
11361874|NCT02137096|OG000|Outcome|High Dose Conditioning|"Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation~Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase~Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase.~Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase~Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm."
11361875|NCT02137096|EG000|Reported Event|High Dose Conditioning|"Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation~Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase~Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase.~Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase~Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm."
11361876|NCT02147834|BG000|Baseline|Ranolazine|"Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11361877|NCT02147834|BG001|Baseline|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11361878|NCT02147834|BG002|Baseline|Total|Total of all reporting groups
11361879|NCT02147834|FG000|Participant Flow|Ranolazine|"Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11361880|NCT02147834|FG001|Participant Flow|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11361881|NCT02147834|OG000|Outcome|Ranolazine|"Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11361882|NCT02147834|OG001|Outcome|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
10962633|NCT00867451|EG001|Reported Event|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
10962634|NCT00867490|BG000|Baseline|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
11239721|NCT02472886|OG000|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
11239722|NCT02472886|OG001|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
11239723|NCT02472886|OG002|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
11239724|NCT02472886|OG000|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
11239725|NCT02472886|OG000|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosiss
11239726|NCT02472886|OG000|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
11239727|NCT02472886|OG000|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV- Naive)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants did not receive any prior ARV therapy.
11239728|NCT02472886|OG001|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV Experienced)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants were on a stable ARV regimen for at least 8 weeks prior to screening.
11239729|NCT02472886|EG000|Reported Event|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
11239730|NCT02472886|EG001|Reported Event|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
11239731|NCT02472886|EG002|Reported Event|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
11239732|NCT02472977|BG000|Baseline|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239733|NCT02472977|BG001|Baseline|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239734|NCT02472977|BG002|Baseline|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239735|NCT02472977|BG003|Baseline|Total|Total of all reporting groups
11239736|NCT02472977|FG000|Participant Flow|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239737|NCT02472977|FG001|Participant Flow|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239738|NCT02472977|FG002|Participant Flow|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239739|NCT02472977|OG000|Outcome|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239740|NCT02472977|OG001|Outcome|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239741|NCT02472977|OG002|Outcome|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239742|NCT02472977|EG000|Reported Event|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239743|NCT02472977|EG001|Reported Event|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239744|NCT02472977|EG002|Reported Event|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
11239745|NCT02473250|BG000|Baseline|Bipolar Depressed|Bipolar depressed subjects had neuroimaging and treatment with a selective serotonin reuptake inhibitor in combination with a mood stabilizer. Fluoxetine was offered first, but citalopram was offered as an alternative if fluoxetine was not clinically appropriate.
11239746|NCT02473250|FG000|Participant Flow|Bipolar Depressed|Bipolar depressed subjects had neuroimaging and treatment with a selective serotonin reuptake inhibitor in combination with a mood stabilizer. Fluoxetine was offered first, but citalopram was offered as an alternative if fluoxetine was not clinically appropriate.
11239747|NCT02473250|OG000|Outcome|Bipolar Depressed|"Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate)~Fluoxetine: Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate).~Citalopram: Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted."
11239748|NCT02473250|OG000|Outcome|Bipolar Depressed|Bipolar depressed subjects had neuroimaging and treatment with a selective serotonin reuptake inhibitor in combination with a mood stabilizer. Fluoxetine was offered first, but citalopram was offered as an alternative if fluoxetine was not clinically appropriate.
11239749|NCT02473250|EG000|Reported Event|Bipolar Depressed|"Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate)~Fluoxetine: Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate).~Citalopram: Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted."
10962635|NCT00867490|FG000|Participant Flow|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
10962636|NCT00867490|OG000|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
10962637|NCT00867490|OG000|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
10962638|NCT00867490|EG000|Reported Event|Phase 1 - Candesartan+HCTZ|4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide (HCTZ) 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.
10962639|NCT00867490|EG001|Reported Event|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
10962640|NCT00867490|EG002|Reported Event|Phase 3 - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.
10962641|NCT00867503|BG000|Baseline|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
10962642|NCT00867503|FG000|Participant Flow|Bendamustine|Bendamustine Hydrochloride (HCL) 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
10962643|NCT00867503|OG000|Outcome|Bendamustine Median Progression Free Surivial in Months|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
10962644|NCT00867503|OG000|Outcome|Bendamustine Grade 4 Toxicity|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
11239750|NCT02473289|BG000|Baseline|Placebo|Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
10962645|NCT00867503|OG000|Outcome|Median Overall Survival in Days|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
10962646|NCT00867503|EG000|Reported Event|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
10962647|NCT00867529|BG000|Baseline|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10962648|NCT00867529|FG000|Participant Flow|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10962649|NCT00867529|OG000|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11239751|NCT02473289|BG001|Baseline|Sirukumab 50 mg|Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
11239752|NCT02473289|BG002|Baseline|Total|Total of all reporting groups
11239753|NCT02473289|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
11239754|NCT02473289|FG001|Participant Flow|Sirukumab 50 mg|Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
11239755|NCT02473289|OG000|Outcome|Placebo|Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
11188418|NCT02113410|OG000|Outcome|Sit 'N' Fit Chair Yoga (SNFCY)|Of the 66 participants who were assigned to SNFCY, 2 dropped after randomization but prior to intervention. Thus, 64 started the intervention; however, 1 dropped during the intervention. Sixty three participants completed the intervention. Of 63 participants, 61 completed at least 12 of 16 sessions and provided data at all five data collection points, for a retention rate of 96% (61/63).
11188419|NCT02113410|OG001|Outcome|Health Education Program (HEP)|Of the 65 participants who were assigned to HEP, 11 dropped after randomization but prior to intervention. Thus, 54 started the intervention; however, 5 dropped during the intervention due to schedule conflict, personal issues, or family illness. Forty nine participants completed the intervention. Of 49 participants, 45 completed at least 12 of 16 sessions and provided data at all five data collection points, for a retention rate of 92% (45/49).
11188420|NCT02113410|OG000|Outcome|Sit 'N' Fit Chair Yoga (SNFCY)|Of the 66 participants who were assigned to SNFCY, 2 dropped after randomization but prior to intervention. Thus, 64 started the intervention; however, 1 dropped during the intervention. Sixty three participants completed the intervention. Of 63 participants, 61 completed at least 12 of 16 sessions (Figure 1) and provided data at all five data collection points, for a retention rate of 96% (61/63).
11188421|NCT02113410|OG001|Outcome|Health Education Program (HEP)|Of the 65 participants who were assigned to HEP, 11 dropped after randomization but prior to intervention. Thus, 54 started the intervention; however, 5 dropped during the intervention due to schedule conflict, personal issues, or family illness. Forty nine participants completed the intervention. Of 49 participants, 45 completed at least 12 of 16 sessions (Figure 1) and provided data at all five data collection points, for a retention rate of 92% (45/49).
11188422|NCT02113410|EG000|Reported Event|Sit 'N' Fit Chair Yoga (SNFCY)|There were no adverse events or serious adverse events associate with SNFCY.
11188423|NCT02113410|EG001|Reported Event|Health Education Program (HEP)|There were no adverse events or serious adverse events associate with HEP.
11188424|NCT02113436|BG000|Baseline|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
11188425|NCT02113436|BG001|Baseline|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
11188426|NCT02113436|BG002|Baseline|Total|Total of all reporting groups
11188427|NCT02113436|FG000|Participant Flow|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
11188428|NCT02113436|FG001|Participant Flow|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
11188429|NCT02113436|FG002|Participant Flow|FP HFA 50 µg - FP/SLM HFA 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg in TP1.
11188430|NCT02113436|FG003|Participant Flow|FP/SLM 50/25 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP/SLM HFA MDI 50/25 μg in TP1.
11188431|NCT02113436|OG000|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
11188432|NCT02113436|OG001|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
11239756|NCT02473289|OG001|Outcome|Sirukumab 50 mg|Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
11188433|NCT02113436|OG000|Outcome|FP 50 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg in TP1.
11188434|NCT02113436|OG001|Outcome|FP/SLM 50/25 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP/SLM HFA MDI 50/25 μg in TP1
11188435|NCT02113436|EG000|Reported Event|Period 1 - FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
11188436|NCT02113436|EG001|Reported Event|Period 1 - FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
11188437|NCT02113436|EG002|Reported Event|Period 2 - FP/SLM HFA 50/25 μg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg or FP/SLM HFA MDI 50/25 µg in TP1.
11188438|NCT02113449|BG000|Baseline|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
11188439|NCT02113449|FG000|Participant Flow|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
11188440|NCT02113449|OG000|Outcome|All Participants|"The participants were asked in the beginning which medication they purchase to relieve nasal congestion. Participant could select only one option available. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."
11188441|NCT02113449|OG000|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
11239757|NCT02473289|EG000|Reported Event|Placebo|Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
10963936|NCT00875017|OG001|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along wuith oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
10963937|NCT00875017|OG002|Outcome|Meal Only|A meal containing a known amount of phosphorous is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of phosphorous is measured.
11188442|NCT02113449|OG000|Outcome|C02 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
11188443|NCT02113449|OG000|Outcome|CO2 Nasal Spray|
11188444|NCT02113449|OG000|Outcome|CO2 Nasal Spray|Score from 1 to 7 indicates how much or how little you think the statement applies to this product. A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it
11188445|NCT02113449|EG000|Reported Event|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
11188446|NCT02113579|BG000|Baseline|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
11188447|NCT02113579|BG001|Baseline|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
11188448|NCT02113579|BG002|Baseline|Total|Total of all reporting groups
11188449|NCT02113579|FG000|Participant Flow|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
11188450|NCT02113579|FG001|Participant Flow|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
11188451|NCT02113579|OG000|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
11188452|NCT02113579|OG001|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
11188453|NCT02113579|EG000|Reported Event|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
11188454|NCT02113579|EG001|Reported Event|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
11188455|NCT02113956|BG000|Baseline|Guy2Guy (G2G)|"Guy2Guy (G2G) is a 6-week HIV prevention program delivered daily via text messaging to 14-18 year old males who self-identify as gay, bisexual, and/or queer. In addition to program content, participants were paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, G2Genie, which shares information about condoms, sex, relationships, and the LGBT community.~Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content was reinforced using brief online videos. The intervention is 5 weeks long. A booster is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active."
11188456|NCT02113956|BG001|Baseline|Healthy Lifestyle Control|The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: STD information, nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 6-weeks in length (Week 6 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.
11188457|NCT02113956|BG002|Baseline|Total|Total of all reporting groups
11188458|NCT02113956|FG000|Participant Flow|Guy2Guy (G2G)|"Guy2Guy (G2G) is a 6-week HIV prevention program delivered daily via text messaging to 14-18 year old males who self-identify as gay, bisexual, and/or queer. In addition to program content, participants were paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, G2Genie, which shares information about condoms, sex, relationships, and the LGBT (lesbian, gay, bisexual, transgender) community.~Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content was reinforced using brief online videos. The intervention is 5 weeks long. A booster is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored by sexual experience."
11188459|NCT02113956|FG001|Participant Flow|Healthy Lifestyle Control|The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: STD (sexual transmitted diseases) information, nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 6-weeks in length (Week 6 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.
11188460|NCT02113956|OG000|Outcome|Guy2Guy (G2G)|"Guy2Guy (G2G) is a 6-week HIV prevention program delivered daily via text messaging to 14-18 year old males who self-identify as gay, bisexual, and/or queer. In addition to program content, participants were paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, G2Genie, which shares information about condoms, sex, relationships, and the LGBT community.~Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content was reinforced using brief online videos. The intervention is 5 weeks long. A booster is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active."
11188461|NCT02113956|OG001|Outcome|Healthy Lifestyle Control|The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: STD information, nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 6-weeks in length (Week 6 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.
10963938|NCT00875017|OG001|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
11239758|NCT02473289|EG001|Reported Event|Sirukumab 50 mg|Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
11239759|NCT02473367|BG000|Baseline|All Enrolled Participants|All participants who enrolled in the study
11239760|NCT02473367|FG000|Participant Flow|Four Period Fixed Sequence|All participants entered the first of four treatment periods. Period 1: 1200 mg raltegravir alone; followed by Period 2: 1200 mg raltegravir and TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3: 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4: 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. There was a maximum 7-day wait between each period where participants were treated once daily with 1200 mg raltegravir.
11239761|NCT02473367|OG000|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
11239762|NCT02473367|OG001|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
11239763|NCT02473367|OG002|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
11239764|NCT02473367|OG003|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
11239765|NCT02473367|EG000|Reported Event|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
11239766|NCT02473367|EG001|Reported Event|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
11239767|NCT02473367|EG002|Reported Event|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
11239768|NCT02473367|EG003|Reported Event|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
11239769|NCT02473393|BG000|Baseline|CDI Group|OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
11239770|NCT02473393|BG001|Baseline|EI Group (50 mg)|"OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239771|NCT02473393|BG002|Baseline|EI Group (100 mg)|"OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239772|NCT02473393|BG003|Baseline|EI Group (200 mg)|"OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239773|NCT02473393|BG004|Baseline|Total|Total of all reporting groups
11239774|NCT02473393|FG000|Participant Flow|CDI Group|OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
11239775|NCT02473393|FG001|Participant Flow|EI Group (50 mg)|"OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239776|NCT02473393|FG002|Participant Flow|EI Group (100 mg)|"OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239777|NCT02473393|FG003|Participant Flow|EI Group (200 mg)|"OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11361883|NCT02147834|EG000|Reported Event|Ranolazine|"Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11361884|NCT02147834|EG001|Reported Event|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11361885|NCT02145390|BG000|Baseline|TURBT, NAC and Chemoradiation|"Transurethral Resection of the Bladder Tumor & Cystoscopy (TURBT);~Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;~For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;~For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;~Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);~International Prostate Symptom Score (IPSS)."
11361886|NCT02145390|FG000|Participant Flow|TURBT, NAC and Chemoradiation|"Transurethral Resection of the Bladder Tumor & Cystoscopy (TURBT);~Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;~For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;~For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;~Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);~International Prostate Symptom Score (IPSS)."
11361887|NCT02145390|OG000|Outcome|TURBT, NAC and Chemoradiation|"Transurethral Resection of the Bladder Tumor & Cystoscopy (TURBT);~Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;~For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;~For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;~Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);~International Prostate Symptom Score (IPSS)."
10963939|NCT00875017|OG000|Outcome|Lanthanum Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
11239778|NCT02473393|OG000|Outcome|CDI Group|OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
11239779|NCT02473393|OG001|Outcome|EI Group (50 mg)|"OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239780|NCT02473393|OG002|Outcome|EI Group (100 mg)|"OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239781|NCT02473393|OG003|Outcome|EI Group (200 mg)|"OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239782|NCT02473393|EG000|Reported Event|CDI Group|OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
11239783|NCT02473393|EG001|Reported Event|EI Group (50 mg)|"OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239784|NCT02473393|EG002|Reported Event|EI Group (100 mg)|"OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11361888|NCT02145390|EG000|Reported Event|TURBT, NAC and Chemoradiation|"Transurethral Resection of the Bladder Tumor & Cystoscopy (TURBT);~Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;~For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;~For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;~Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);~International Prostate Symptom Score (IPSS)."
11361889|NCT02132884|BG000|Baseline|Arm A (Standard of Care Treatment)|"Patients receive standard of care treatment based on the discretion of the treating physician.~therapeutic procedure: Receive standard of care treatment~laboratory biomarker analysis: Correlative studies"
11361890|NCT02132884|BG001|Baseline|Arm B (Genetic Sequencing and Targeted Therapy)|"Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~targeted therapy: Receive specific targeted therapy~laboratory biomarker analysis: Correlative studies"
11361891|NCT02132884|BG002|Baseline|Total|Total of all reporting groups
11361892|NCT02132884|FG000|Participant Flow|Arm A (Standard of Care Treatment)|"Patients receive standard of care treatment based on the discretion of the treating physician.~therapeutic procedure: Receive standard of care treatment~laboratory biomarker analysis: Correlative studies"
11188462|NCT02113956|EG000|Reported Event|Guy2Guy (G2G)|"Guy2Guy (G2G) is a 6-week HIV prevention program delivered daily via text messaging to 14-18 year old males who self-identify as gay, bisexual, and/or queer. In addition to program content, participants were paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, G2Genie, which shares information about condoms, sex, relationships, and the LGBT community.~Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content was reinforced using brief online videos. The intervention is 5 weeks long. A booster is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active."
11361893|NCT02132884|FG001|Participant Flow|Arm B (Genetic Sequencing and Targeted Therapy)|"Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~targeted therapy: Receive specific targeted therapy~laboratory biomarker analysis: Correlative studies"
11361894|NCT02132884|OG000|Outcome|Arm A (Standard of Care Treatment)|"Patients receive standard of care treatment based on the discretion of the treating physician.~therapeutic procedure: Receive standard of care treatment~laboratory biomarker analysis: Correlative studies"
11361895|NCT02132884|OG001|Outcome|Arm B (Genetic Sequencing and Targeted Therapy)|"Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~targeted therapy: Receive specific targeted therapy~laboratory biomarker analysis: Correlative studies"
11361896|NCT02132884|EG000|Reported Event|Arm A (Standard of Care Treatment)|"Patients receive standard of care treatment based on the discretion of the treating physician.~therapeutic procedure: Receive standard of care treatment~laboratory biomarker analysis: Correlative studies"
11361897|NCT02132884|EG001|Reported Event|Arm B (Genetic Sequencing and Targeted Therapy)|"Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~targeted therapy: Receive specific targeted therapy~laboratory biomarker analysis: Correlative studies"
11361898|NCT02144155|BG000|Baseline|All Participants|This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study.
11361899|NCT02144155|FG000|Participant Flow|All Participants|This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study.
11361900|NCT02144155|OG000|Outcome|All Participants|
11361901|NCT02144155|EG000|Reported Event|All Participants|This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study.
11361902|NCT02140788|BG000|Baseline|All Subjects Who Consented|All subjects who signed a consent form
11361903|NCT02140788|FG000|Participant Flow|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
11361904|NCT02140788|FG001|Participant Flow|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
11361905|NCT02140788|FG002|Participant Flow|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
11361906|NCT02140788|FG003|Participant Flow|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
11361907|NCT02140788|OG000|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
11361908|NCT02140788|OG001|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
11361909|NCT02140788|OG002|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
11361910|NCT02140788|OG003|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
11361911|NCT02140788|EG000|Reported Event|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
11361912|NCT02140788|EG001|Reported Event|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
11361913|NCT02140788|EG002|Reported Event|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
11361914|NCT02140788|EG003|Reported Event|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
11361915|NCT02150863|BG000|Baseline|Ultrapulse Laser Alone|Ultrapulse Carbon Dioxide Laser
11361916|NCT02150863|BG001|Baseline|Ultrapulse Laser Plus Cellutome Harvesting System|"Ultrapulse Carbon Dioxide Laser~Cellutome epidermal harvesting system"
11361917|NCT02150863|BG002|Baseline|Control|Control group
11361918|NCT02150863|BG003|Baseline|Total|Total of all reporting groups
11361919|NCT02150863|FG000|Participant Flow|Ultrapulse Laser Alone|Ultrapulse Carbon Dioxide Laser
11361920|NCT02150863|FG001|Participant Flow|Ultrapulse Laser Plus Cellutome Harvesting System|"Ultrapulse Carbon Dioxide Laser~Cellutome epidermal harvesting system"
11361921|NCT02150863|FG002|Participant Flow|Control|Control group, no treatment
11361922|NCT02150863|OG000|Outcome|Ultrapulse Laser Alone|Ultrapulse Carbon Dioxide Laser
11361923|NCT02150863|OG001|Outcome|Ultrapulse Laser Plus Cellutome Harvesting System|"Ultrapulse Carbon Dioxide Laser~Cellutome epidermal harvesting system"
11361924|NCT02150863|OG002|Outcome|Control|Control group (no laser or CelluTome)
11361925|NCT02150863|EG000|Reported Event|Ultrapulse Laser Alone|Ultrapulse Carbon Dioxide Laser
11361926|NCT02150863|EG001|Reported Event|Ultrapulse Laser Plus Cellutome Harvesting System|"Ultrapulse Carbon Dioxide Laser~Cellutome epidermal harvesting system"
11361927|NCT02150863|EG002|Reported Event|Control|Control site
11361928|NCT02145169|BG000|Baseline|Nitrous Oxide Arm|"Patients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask~Inhaled Nitrous Oxide: Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide"
11361929|NCT02145169|FG000|Participant Flow|Nitrous Oxide Arm|"Patients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask~Inhaled Nitrous Oxide: Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide"
11361930|NCT02145169|OG000|Outcome|Nitrous Oxide Arm|"Patients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask~Inhaled Nitrous Oxide: Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide"
11361931|NCT02145169|EG000|Reported Event|Nitrous Oxide Arm|"Patients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask~Inhaled Nitrous Oxide: Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide"
11361932|NCT02130622|BG000|Baseline|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
11361933|NCT02130622|BG001|Baseline|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
11361934|NCT02130622|BG002|Baseline|Total|Total of all reporting groups
11361935|NCT02130622|FG000|Participant Flow|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
11361936|NCT02130622|FG001|Participant Flow|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
11361937|NCT02130622|OG000|Outcome|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
11361938|NCT02130622|OG001|Outcome|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
11361939|NCT02130622|EG000|Reported Event|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
11361940|NCT02130622|EG001|Reported Event|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
11361941|NCT02133534|BG000|Baseline|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
11361942|NCT02133534|FG000|Participant Flow|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
11188463|NCT02113956|EG001|Reported Event|Healthy Lifestyle Control|The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: STD information, nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 6-weeks in length (Week 6 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.
11188464|NCT02114151|BG000|Baseline|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
11188465|NCT02114151|FG000|Participant Flow|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
11188466|NCT02114151|OG000|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
11188467|NCT02114151|EG000|Reported Event|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
11188468|NCT02114164|BG000|Baseline|AirSeal System|"This group receives the AirSeal System for intraoperative insufflation.~AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar."
11188469|NCT02114164|BG001|Baseline|Standard Endopath|"This group receives the Standard Endopath Trocar for intraoperative insufflation.~Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation."
11188470|NCT02114164|BG002|Baseline|Total|Total of all reporting groups
11188471|NCT02114164|FG000|Participant Flow|AirSeal System|"This group receives the AirSeal System for intraoperative insufflation.~AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar."
11188472|NCT02114164|FG001|Participant Flow|Standard Endopath|"This group receives the Standard Endopath Trocar for intraoperative insufflation.~Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation."
11188473|NCT02114164|OG000|Outcome|AirSeal System|"This group receives the AirSeal System for intraoperative insufflation.~AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar."
11188474|NCT02114164|OG001|Outcome|Standard Endopath|"This group receives the Standard Endopath Trocar for intraoperative insufflation.~Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation."
11188475|NCT02114164|EG000|Reported Event|AirSeal System|"This group receives the AirSeal System for intraoperative insufflation.~AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar."
11188476|NCT02114164|EG001|Reported Event|Standard Endopath|"This group receives the Standard Endopath Trocar for intraoperative insufflation.~Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation."
11188477|NCT02114177|BG000|Baseline|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
11188478|NCT02114177|BG001|Baseline|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
11188479|NCT02114177|BG002|Baseline|Total|Total of all reporting groups
11188480|NCT02114177|FG000|Participant Flow|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
11188481|NCT02114177|FG001|Participant Flow|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
11188482|NCT02114177|OG000|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
11188483|NCT02114177|OG001|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
11188484|NCT02114177|EG000|Reported Event|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
11188485|NCT02114177|EG001|Reported Event|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
11188486|NCT02114203|BG000|Baseline|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
11188487|NCT02114203|BG001|Baseline|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
11188488|NCT02114203|BG002|Baseline|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
11188489|NCT02114203|BG003|Baseline|Total|Total of all reporting groups
11188490|NCT02114203|FG000|Participant Flow|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
11188491|NCT02114203|FG001|Participant Flow|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
11188492|NCT02114203|FG002|Participant Flow|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
11188493|NCT02114203|OG000|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
11188494|NCT02114203|OG001|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
11188495|NCT02114203|OG002|Outcome|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
11188496|NCT02114203|EG000|Reported Event|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
11188497|NCT02114203|EG001|Reported Event|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
11188498|NCT02114203|EG002|Reported Event|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
11239785|NCT02473393|EG003|Reported Event|EI Group (200 mg)|"OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.~The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step."
11239786|NCT02473471|BG000|Baseline|All Study Participants|Includes groups randomized to receive MOP intervention on one side while the other side serve as control side.
11239787|NCT02473471|FG000|Participant Flow|All Study Participants|"Split-mouth design study in which the intervention (MOP Side) was randomly assigned to either right or the left side in the maxillary arch where other side serves as a control.~Randomization was accomplished with block randomization with a permuted block size of 2 with 1:1 allocation ratio to either right or left with allocations concealed in opaque, sealed envelopes. Blinding was applicable at data collection and analysis stage."
11239788|NCT02473471|OG000|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
11239789|NCT02473471|OG001|Outcome|Control Side|Non intervention side
11239790|NCT02473471|OG001|Outcome|Control Side|No intervention in the other side of maxilla (control side)
11239791|NCT02473471|OG000|Outcome|MOP Side|Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine.
11239792|NCT02473471|OG000|Outcome|MOP Side|The Micro-osteoperforation side
11239793|NCT02473471|OG001|Outcome|Control Side|Non-intervention side
11239794|NCT02473471|EG000|Reported Event|MOP Side|"Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine.~Micro-osteoperforation: Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute."
11239795|NCT02473471|EG001|Reported Event|Control Side|No intervention in the other side of maxilla (control side)
11239796|NCT02473510|BG000|Baseline|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
11239797|NCT02473510|BG001|Baseline|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
11239798|NCT02473510|BG002|Baseline|Total|Total of all reporting groups
11239799|NCT02473510|FG000|Participant Flow|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
11239800|NCT02473510|FG001|Participant Flow|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
10963940|NCT00875017|OG001|Outcome|Sevelamer Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
11239801|NCT02473510|OG000|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
11239802|NCT02473510|OG001|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
11239803|NCT02473510|EG000|Reported Event|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
11239804|NCT02473510|EG001|Reported Event|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
11239805|NCT02473614|BG000|Baseline|All Study Participants|Participants who were randomized to participate in Music Glove or Conventional Hand Exercise Program for 3 weeks, then after a three-week washout period they participated in either Music Glove or Conventional Hand Exercise Program for 3 weeks.
11239806|NCT02473614|FG000|Participant Flow|Music Glove First, Then Conventional Hand Exercise Program|Participants first participated in Music Glove therapy intervention for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, they participated in a conventional hand therapy program for 3 weeks with a minimum of 3 hours per week.
11239807|NCT02473614|FG001|Participant Flow|Conventional Hand Exercise Program First, Then Music Glove|Participants first participated in conventional hand therapy for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, then they participated in the Music Glove therapy intervention for 3 weeks with a minimum of 3 hours per week.
11239808|NCT02473614|OG000|Outcome|Music Glove First, Then Conventional Hand Exercise Program|Participants first participated in Music Glove therapy intervention for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, they participated in a conventional hand therapy program for 3 weeks with a minimum of 3 hours per week.
11239809|NCT02473614|OG001|Outcome|Conventional Hand Exercise Program First, Then Music Glove|Participants first participated in conventional hand therapy for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, then they participated in the Music Glove therapy intervention for 3 weeks with a minimum of 3 hours per week.
11361943|NCT02133534|OG000|Outcome|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
11361944|NCT02133534|EG000|Reported Event|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
11361945|NCT02134912|BG000|Baseline|Arm I (Crizotinib, Pemetrexed Disodium)|"Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.~crizotinib: Given PO~pemetrexed disodium: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11361946|NCT02134912|BG001|Baseline|Arm II (Pemetrexed Disodium)|"ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.~pemetrexed disodium: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11361947|NCT02134912|BG002|Baseline|Total|Total of all reporting groups
11361948|NCT02134912|FG000|Participant Flow|Arm I (Crizotinib, Pemetrexed Disodium)|"Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.~crizotinib: Given PO~pemetrexed disodium: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11361949|NCT02134912|FG001|Participant Flow|Arm II (Pemetrexed Disodium)|"ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.~pemetrexed disodium: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11361950|NCT02134912|OG000|Outcome|Arm I (Crizotinib, Pemetrexed Disodium)|"Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.~crizotinib: Given PO~pemetrexed disodium: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11361951|NCT02134912|OG001|Outcome|Arm II (Pemetrexed Disodium)|"ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.~pemetrexed disodium: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11361952|NCT02134912|EG000|Reported Event|Arm I (Crizotinib, Pemetrexed Disodium)|"Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.~crizotinib: Given PO~pemetrexed disodium: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11361953|NCT02134912|EG001|Reported Event|Arm II (Pemetrexed Disodium)|"ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.~pemetrexed disodium: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11361954|NCT02131155|BG000|Baseline|Afatinib (BIBW2992)|Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
11361955|NCT02131155|BG001|Baseline|Placebo|Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (~250 millilitre) up to a period of 80 weeks.
11361956|NCT02131155|BG002|Baseline|Total|Total of all reporting groups
11361957|NCT02131155|FG000|Participant Flow|Afatinib (BIBW2992)|Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
11361958|NCT02131155|FG001|Participant Flow|Placebo|Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (~250 millilitre) up to a period of 80 weeks.
11361959|NCT02131155|OG000|Outcome|Afatinib (BIBW2992)|Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
11361960|NCT02131155|OG001|Outcome|Placebo|Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (~250 millilitre) up to a period of 80 weeks.
11361961|NCT02131155|EG000|Reported Event|Placebo|Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (~250 millilitre) up to a period of 80 weeks.
11361962|NCT02131155|EG001|Reported Event|Afatinib (BIBW2992)|Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
11361963|NCT02117050|BG000|Baseline|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
11361964|NCT02117050|FG000|Participant Flow|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
11361965|NCT02117050|OG000|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
11361966|NCT02117050|OG000|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
11361967|NCT02117050|EG000|Reported Event|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
11361968|NCT02110069|BG000|Baseline|Vincristine|"Induction phase: participants assigned to vincristine will receive vincristine weekly at a dose of 0.05mg/kg/dose IV (for participants less than 10kg) or a dose of 1.5 mg/m2/dose (for participants greater than 10kg) for 2 months.~Maintenance: if participants continue to receive vincristine weekly for 2 months, every 2 weeks for 5 months and every 3 weeks for 5 months.~Vincristine: Vincristine dose dependent upon weight. Weekly for 2 months (Induction); Weekly 2 months; every 2 weeks for next 5 months; every 3 weeks for 5 months (Maintenance)"
11361969|NCT02110069|BG001|Baseline|Sirolimus|"Sirolimus will be administered at a dose of 0.8mg/m2/dose twice a day on a continuous dosing schedule throughout the trial for participants randomized to Sirolimus or for participants who fail vincristine may cross-over to the sirolimus arm.~Sirolimus trough levels will be maintained between 10-15 ng/ml.~Sirolimus: Continuous dosing to maintain trough level of 10-15ng/ml."
11361970|NCT02110069|BG002|Baseline|Total|Total of all reporting groups
11361971|NCT02110069|FG000|Participant Flow|Vincristine|"Induction phase: participants assigned to vincristine will receive vincristine weekly at a dose of 0.05mg/kg/dose IV (for participants less than 10kg) or a dose of 1.5 mg/m2/dose (for participants greater than 10kg) for 2 months.~Maintenance: if participants continue to receive vincristine weekly for 2 months, every 2 weeks for 5 months and every 3 weeks for 5 months.~Vincristine: Vincristine dose dependent upon weight. Weekly for 2 months (Induction); Weekly 2 months; every 2 weeks for next 5 months; every 3 weeks for 5 months (Maintenance)"
11361972|NCT02110069|FG001|Participant Flow|Sirolimus|"Sirolimus will be administered at a dose of 0.8mg/m2/dose twice a day on a continuous dosing schedule throughout the trial for participants randomized to Sirolimus or for participants who fail vincristine may cross-over to the sirolimus arm.~Sirolimus trough levels will be maintained between 10-15 ng/ml.~Sirolimus: Continuous dosing to maintain trough level of 10-15ng/ml."
11361973|NCT02110069|OG000|Outcome|Vincristine|"Induction phase: participants assigned to vincristine will receive vincristine weekly at a dose of 0.05mg/kg/dose IV (for participants less than 10kg) or a dose of 1.5 mg/m2/dose (for participants greater than 10kg) for 2 months.~Maintenance: if participants continue to receive vincristine weekly for 2 months, every 2 weeks for 5 months and every 3 weeks for 5 months.~Vincristine: Vincristine dose dependent upon weight. Weekly for 2 months (Induction); Weekly 2 months; every 2 weeks for next 5 months; every 3 weeks for 5 months (Maintenance)"
11361974|NCT02110069|OG001|Outcome|Sirolimus|"Sirolimus will be administered at a dose of 0.8mg/m2/dose twice a day on a continuous dosing schedule throughout the trial for participants randomized to Sirolimus or for participants who fail vincristine may cross-over to the sirolimus arm.~Sirolimus trough levels will be maintained between 10-15 ng/ml.~Sirolimus: Continuous dosing to maintain trough level of 10-15ng/ml."
11361975|NCT02110069|EG000|Reported Event|Vincristine|"Induction phase: participants assigned to vincristine will receive vincristine weekly at a dose of 0.05mg/kg/dose IV (for participants less than 10kg) or a dose of 1.5 mg/m2/dose (for participants greater than 10kg) for 2 months.~Maintenance: if participants continue to receive vincristine weekly for 2 months, every 2 weeks for 5 months and every 3 weeks for 5 months.~Vincristine: Vincristine dose dependent upon weight. Weekly for 2 months (Induction); Weekly 2 months; every 2 weeks for next 5 months; every 3 weeks for 5 months (Maintenance)"
11188499|NCT02114216|BG000|Baseline|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
11361976|NCT02110069|EG001|Reported Event|Sirolimus|"Sirolimus will be administered at a dose of 0.8mg/m2/dose twice a day on a continuous dosing schedule throughout the trial for participants randomized to Sirolimus or for participants who fail vincristine may cross-over to the sirolimus arm.~Sirolimus trough levels will be maintained between 10-15 ng/ml.~Sirolimus: Continuous dosing to maintain trough level of 10-15ng/ml."
11361977|NCT02110277|BG000|Baseline|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
11361978|NCT02110277|FG000|Participant Flow|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
11361979|NCT02110277|OG000|Outcome|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
11361980|NCT02110277|EG000|Reported Event|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
11188500|NCT02114216|BG001|Baseline|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
11361981|NCT02109809|BG000|Baseline|Supportive Care (TLI)|"Patients undergo LD-TLI daily for 1-2 days.~total nodal irradiation: Undergo TLI~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
11361982|NCT02109809|FG000|Participant Flow|Supportive Care (TLI)|"Patients undergo LD-TLI daily for 1-2 days.~total nodal irradiation: Undergo TLI~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
11361983|NCT02109809|OG000|Outcome|Supportive Care (TLI)|"Patients undergo LD-TLI daily for 1-2 days.~total nodal irradiation: Undergo TLI~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
11361984|NCT02109809|EG000|Reported Event|Supportive Care (TLI)|"Patients undergo LD-TLI daily for 1-2 days.~total nodal irradiation: Undergo TLI~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
11361985|NCT02105116|BG000|Baseline|Treatment (Combination Chemotherapy, DLI)|"INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have >5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician.~ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.~fludarabine phosphate: Given IV~cytarabine: Given IV~donor lymphocytes: Undergo infusion of donor lymphocytes~laboratory biomarker analysis: Correlative studies~G-CSF: Given IV"
11361986|NCT02105116|FG000|Participant Flow|Treatment (Combination Chemotherapy, DLI)|"INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have >5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician.~ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.~fludarabine phosphate: Given IV~cytarabine: Given IV~donor lymphocytes: Undergo infusion of donor lymphocytes~laboratory biomarker analysis: Correlative studies~G-CSF: Given IV"
11361987|NCT02105116|OG000|Outcome|Treatment (Combination Chemotherapy, DLI)|"INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have >5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician.~ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.~fludarabine phosphate: Given IV~cytarabine: Given IV~donor lymphocytes: Undergo infusion of donor lymphocytes~laboratory biomarker analysis: Correlative studies~G-CSF: Given IV"
11361988|NCT02105116|EG000|Reported Event|Treatment (Combination Chemotherapy, DLI)|"INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have >5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician.~ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.~fludarabine phosphate: Given IV~cytarabine: Given IV~donor lymphocytes: Undergo infusion of donor lymphocytes~laboratory biomarker analysis: Correlative studies~G-CSF: Given IV"
11361989|NCT02099318|BG000|Baseline|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation f"
11361990|NCT02099318|BG001|Baseline|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
11361991|NCT02099318|BG002|Baseline|Total|Total of all reporting groups
11361992|NCT02099318|FG000|Participant Flow|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
11361993|NCT02099318|FG001|Participant Flow|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
11361994|NCT02099318|OG000|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation f"
11361995|NCT02099318|OG001|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
11361996|NCT02099318|OG000|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
11361997|NCT02099318|OG000|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
11361998|NCT02099318|EG000|Reported Event|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation for w"
11361999|NCT02099318|EG001|Reported Event|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
11362000|NCT02099344|BG000|Baseline|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
11362001|NCT02099344|BG001|Baseline|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
11362002|NCT02099344|BG002|Baseline|Total|Total of all reporting groups
11362003|NCT02099344|FG000|Participant Flow|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
11362004|NCT02099344|FG001|Participant Flow|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
11188501|NCT02114216|BG002|Baseline|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
11188502|NCT02114216|BG003|Baseline|Total|Total of all reporting groups
11188503|NCT02114216|FG000|Participant Flow|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
11188504|NCT02114216|FG001|Participant Flow|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
11188505|NCT02114216|FG002|Participant Flow|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
11362005|NCT02099344|OG000|Outcome|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
11362006|NCT02099344|OG001|Outcome|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
11362007|NCT02099344|OG000|Outcome|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access"
11362008|NCT02099344|OG001|Outcome|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Propaten: Surgical placement of graft for hemodialysis access"
11188506|NCT02114216|OG000|Outcome|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
11188507|NCT02114216|OG001|Outcome|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
11188508|NCT02114216|OG002|Outcome|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
11188509|NCT02114216|OG000|Outcome|Control Group|"Subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
11188510|NCT02114216|OG001|Outcome|ERD Group|"Subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
11188511|NCT02114216|OG002|Outcome|NERD Group|"Subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
11362009|NCT02099344|EG000|Reported Event|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
11362010|NCT02099344|EG001|Reported Event|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
11362011|NCT02094352|BG000|Baseline|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
11188512|NCT02114216|EG000|Reported Event|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
11188513|NCT02114216|EG001|Reported Event|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
11188514|NCT02114216|EG002|Reported Event|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
11362012|NCT02094352|BG001|Baseline|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
11188515|NCT02114268|BG000|Baseline|Placebo|Participants received placebo on Day 1.
11188516|NCT02114268|BG001|Baseline|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
11188517|NCT02114268|BG002|Baseline|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
11188518|NCT02114268|BG003|Baseline|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
11188519|NCT02114268|BG004|Baseline|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
10963941|NCT00875017|OG002|Outcome|Meal Only|A meal containing a known amount of calcium is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of calcium is measured.
10963942|NCT00875017|EG000|Reported Event|Lanthanum Carbonate|
11188520|NCT02114268|BG005|Baseline|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
11188521|NCT02114268|BG006|Baseline|Total|Total of all reporting groups
11188522|NCT02114268|FG000|Participant Flow|Placebo|Participants received placebo on Day 1.
11188523|NCT02114268|FG001|Participant Flow|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
11188524|NCT02114268|FG002|Participant Flow|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
11188525|NCT02114268|FG003|Participant Flow|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
11188526|NCT02114268|FG004|Participant Flow|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
11188527|NCT02114268|FG005|Participant Flow|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
11188528|NCT02114268|OG000|Outcome|Placebo|Participants received placebo on Day 1.
11188529|NCT02114268|OG001|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
11188530|NCT02114268|OG002|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
11188531|NCT02114268|OG003|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
11188532|NCT02114268|OG004|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
11188533|NCT02114268|OG005|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
11188534|NCT02114268|OG000|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
11188535|NCT02114268|OG001|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
11188536|NCT02114268|OG002|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
11188537|NCT02114268|OG003|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
11188538|NCT02114268|OG004|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
11188539|NCT02114268|EG000|Reported Event|Placebo|Participants received placebo on Day 1.
11188540|NCT02114268|EG001|Reported Event|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
11188541|NCT02114268|EG002|Reported Event|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
11188542|NCT02114268|EG003|Reported Event|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
11188543|NCT02114268|EG004|Reported Event|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
11188544|NCT02114268|EG005|Reported Event|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
11188545|NCT02114307|BG000|Baseline|Test Device|Patients received the REVITIVE IX device for 6 weeks of home usage.
11188546|NCT02114307|BG001|Baseline|Sham Device|Sham REVITIVE IX for 6 weeks of home usage.
11188547|NCT02114307|BG002|Baseline|Total|Total of all reporting groups
11188548|NCT02114307|FG000|Participant Flow|REVITIVE IX: Actual Device|"Trial participants will receive the true Revitive IX device~REVITIVE IX: neuromuscular electrical stimulation device"
11188549|NCT02114307|FG001|Participant Flow|REVITIVE IX: Sham Device|"Trial participants will receive a sham device~REVITIVE IX: sham device"
11188550|NCT02114307|OG000|Outcome|REVITIVE IX: Actual Device|"Trial participants will receive the true Revitive IX device~REVITIVE IX: neuromuscular electrical stimulation device"
11188551|NCT02114307|OG001|Outcome|REVITIVE IX: Sham Device|"Trial participants will receive a sham device~REVITIVE IX: neuromuscular electrical stimulation device"
11188552|NCT02114307|OG000|Outcome|Test Device|Patients received the REVITIVE IX device for 6 weeks of home usage.
11188553|NCT02114307|OG001|Outcome|Sham Device|Sham REVITIVE IX for 6 weeks of home usage.
11188554|NCT02114307|EG000|Reported Event|REVITIVE IX: Actual Device|"Trial participants will receive the true Revitive IX device~REVITIVE IX: neuromuscular electrical stimulation device"
11188555|NCT02114307|EG001|Reported Event|REVITIVE IX: Sham Device|"Trial participants will receive a sham device~REVITIVE IX: sham device"
11188556|NCT02114385|BG000|Baseline|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11188557|NCT02114385|BG001|Baseline|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11188558|NCT02114385|BG002|Baseline|Total|Total of all reporting groups
11188559|NCT02114385|FG000|Participant Flow|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11188560|NCT02114385|FG001|Participant Flow|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11188561|NCT02114385|OG000|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11188562|NCT02114385|OG001|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11188563|NCT02114385|EG000|Reported Event|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11188564|NCT02114385|EG001|Reported Event|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
11188565|NCT02114515|BG000|Baseline|Usual Care|"Hospital usual care~Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge."
11362013|NCT02094352|BG002|Baseline|Total|Total of all reporting groups
11188566|NCT02114515|BG001|Baseline|Usual Care + PArTNER|"Navigator intervention: (Community health worker, peer-led telephone support line, usual care)~Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.~Community health worker: The community health worker provides social support, literacy appropriate education, and acts as a conduit between the patient and the patient's medical team~Peer-led telephone support line: The peer-led telephone support line will provide social support, peer-to-peer coaching, and facilitate communication with the patient's medical care team."
11188567|NCT02114515|BG002|Baseline|Total|Total of all reporting groups
11188568|NCT02114515|FG000|Participant Flow|Usual Care|"Hospital usual care~Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge."
11188569|NCT02114515|FG001|Participant Flow|Usual Care + PArTNER|"Navigator intervention: (Community health worker, peer-led telephone support line, usual care)~Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.~Community health worker: The community health worker provides social support, literacy appropriate education, and acts as a conduit between the patient and the patient's medical team~Peer-led telephone support line: The peer-led telephone support line will provide social support, peer-to-peer coaching, and facilitate communication with the patient's medical care team."
11188570|NCT02114515|OG000|Outcome|Usual Care|"Hospital usual care~Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge."
11188571|NCT02114515|OG001|Outcome|Usual Care + PArTNER|"Navigator intervention: (Community health worker, peer-led telephone support line, usual care)~Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.~Community health worker: The community health worker provides social support, literacy appropriate education, and acts as a conduit between the patient and the patient's medical team~Peer-led telephone support line: The peer-led telephone support line will provide social support, peer-to-peer coaching, and facilitate communication with the patient's medical care team."
11188572|NCT02114515|EG000|Reported Event|Usual Care|"Hospital usual care~Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge."
11188573|NCT02114515|EG001|Reported Event|Usual Care + PArTNER|"Navigator intervention: (Community health worker, peer-led telephone support line, usual care)~Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.~Community health worker: The community health worker provides social support, literacy appropriate education, and acts as a conduit between the patient and the patient's medical team~Peer-led telephone support line: The peer-led telephone support line will provide social support, peer-to-peer coaching, and facilitate communication with the patient's medical care team."
11188574|NCT02114606|BG000|Baseline|EoE Patients|Patients who have been diagnosed with EoE as per recent guidelines will be enrolled. Samples will be obtained using the Cytosponge™ Cell Collection Device (Cytosponge) prior to participants' routine endoscopy with biopsy.
11188575|NCT02114606|FG000|Participant Flow|EoE Patients|Patients who have been diagnosed with EoE as per recent guidelines will be enrolled. Samples will be obtained using the Cytosponge™ Cell Collection Device (Cytosponge) prior to participants' routine endoscopy with biopsy.
11188576|NCT02114606|OG000|Outcome|EoE Patients|Patients who have been diagnosed with EoE as per recent guidelines will be enrolled. Samples will be obtained using the Cytosponge™ Cell Collection Device (Cytosponge) prior to participants' routine endoscopy with biopsy.
11188577|NCT02114606|EG000|Reported Event|EoE Patients|Patients who have been diagnosed with EoE as per recent guidelines will be enrolled. Samples will be obtained using the Cytosponge™ Cell Collection Device (Cytosponge) prior to participants' routine endoscopy with biopsy.
11188578|NCT02114684|BG000|Baseline|Moxifloxacin|"A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.~The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.~Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38-54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38-54 and ≥55 kg, respectively."
11188579|NCT02114684|BG001|Baseline|Control|"An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.~Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).~During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid."
11188580|NCT02114684|BG002|Baseline|Total|Total of all reporting groups
11188581|NCT02114684|FG000|Participant Flow|Moxifloxacin|"A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.~The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.~Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38-54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38-54 and ≥55 kg, respectively."
10963943|NCT00875017|EG001|Reported Event|Sevelamer Carbonate|
10963944|NCT00875017|EG002|Reported Event|Meal Only|
11362014|NCT02094352|FG000|Participant Flow|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
11362015|NCT02094352|FG001|Participant Flow|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
11362016|NCT02094352|OG000|Outcome|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
11362017|NCT02094352|OG001|Outcome|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
11362018|NCT02094352|EG000|Reported Event|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
11362019|NCT02094352|EG001|Reported Event|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
11362020|NCT02096042|BG000|Baseline|Brentuximab Vedotin|Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
11362021|NCT02096042|FG000|Participant Flow|Brentuximab Vedotin|Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
11362022|NCT02096042|FG001|Participant Flow|Brentuximab Vedotin + 5-Azacytidine|Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. 5-azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.
11362023|NCT02096042|FG002|Participant Flow|MTD Brentuximab Vedotin + 5-Azacytidine|Phase II Dose-Expansion Phase: Brentuximab Vedotin at MTD from dose-escalation phase IV on Days 1, 8, and 15 of each 28-day cycle. 5-Azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.Up to 12 cycles of treatment (weekly + monthly combined).
11188582|NCT02114684|FG001|Participant Flow|Control|"An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.~Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).~During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid."
11362024|NCT02096042|OG000|Outcome|Brentuximab Vedotin + 5-Azacytidine|Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. 5-azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.
11362025|NCT02096042|OG000|Outcome|Brentuximab Vedotin|Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
11362026|NCT02096042|OG001|Outcome|Brentuximab Vedotin + 5-Azacytidine|Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. 5-azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.
11362027|NCT02096042|OG002|Outcome|MTD Brentuximab Vedotin + 5-Azacytidine|Phase II Dose-Expansion Phase: Brentuximab Vedotin at MTD from dose-escalation phase IV on Days 1, 8, and 15 of each 28-day cycle. 5-Azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.Up to 12 cycles of treatment (weekly + monthly combined).
11362028|NCT02096042|EG000|Reported Event|Brentuximab Vedotin|Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
11362029|NCT02088957|BG000|Baseline|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
11362030|NCT02088957|FG000|Participant Flow|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
11362031|NCT02088957|FG001|Participant Flow|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
11362032|NCT02088957|OG000|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
11362033|NCT02088957|OG001|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
11362034|NCT02088957|EG000|Reported Event|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
11362035|NCT02088957|EG001|Reported Event|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
11376258|NCT00980538|EG000|Reported Event|Etravirine|Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research & Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than [<] 20 kilograms [kg]; ETR 125 mg bid for weight 20 to <25 kg; ETR 150 mg bid for weight 25 to <30 kg; and 200 mg bid for weight greater than or equal to [>=] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
11376259|NCT00980460|BG000|Baseline|Very Low-risk Group|"Patients undergo surgery and then receive no further treatment.~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11376260|NCT00980460|BG001|Baseline|Low-risk Group (Regimen T)|"Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
10963945|NCT00875017|EG003|Reported Event|Fasting|
11362036|NCT02093689|BG000|Baseline|Part 1 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
11362037|NCT02093689|BG001|Baseline|Part 2 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
11362038|NCT02093689|BG002|Baseline|Part 2 Placebo|Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.
11362039|NCT02093689|BG003|Baseline|Total|Total of all reporting groups
11362040|NCT02093689|FG000|Participant Flow|Part 1 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
11362041|NCT02093689|FG001|Participant Flow|Part 2 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
11362042|NCT02093689|FG002|Participant Flow|Part 2 Placebo|Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.
11362043|NCT02093689|OG000|Outcome|Part 1 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
11362044|NCT02093689|OG001|Outcome|Part 2 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
11362045|NCT02093689|OG002|Outcome|Part 2 Placebo|Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solution.
11362046|NCT02093689|EG000|Reported Event|Part 1 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
11362047|NCT02091752|BG000|Baseline|Ruxolitinib|All participants received ruxolitinib.
11362048|NCT02091752|FG000|Participant Flow|Ruxolitinib|All participants received ruxolitinib.
11362049|NCT02091752|OG000|Outcome|Ruxolitinib|All participants received ruxolitinib.
11362050|NCT02091752|EG000|Reported Event|Ruxolitinib|All participants received ruxolitinib.
11362051|NCT02068547|BG000|Baseline|Surigical Best Practice|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
11362052|NCT02068547|BG001|Baseline|Group 2|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
11362053|NCT02068547|BG002|Baseline|Total|Total of all reporting groups
11362054|NCT02068547|FG000|Participant Flow|Autograft/DBM/Cadaver Allo|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
11362055|NCT02068547|FG001|Participant Flow|Autograft/BMAC|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
11362056|NCT02068547|OG000|Outcome|Surigical Best Practice|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
11362057|NCT02068547|OG001|Outcome|Group 2|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
11362058|NCT02068547|EG000|Reported Event|Surigical Best Practice|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
11362059|NCT02068547|EG001|Reported Event|Group 2|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
11362060|NCT02075411|BG000|Baseline|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
11362061|NCT02075411|BG001|Baseline|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
11362062|NCT02075411|BG002|Baseline|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
11362063|NCT02075411|BG003|Baseline|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
11362064|NCT02075411|BG004|Baseline|Total|Total of all reporting groups
11362065|NCT02075411|FG000|Participant Flow|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
11362066|NCT02075411|FG001|Participant Flow|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
11362067|NCT02075411|FG002|Participant Flow|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
11362068|NCT02075411|FG003|Participant Flow|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
11362069|NCT02075411|OG000|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
11362070|NCT02075411|OG001|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
11362071|NCT02075411|OG002|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
11362072|NCT02075411|OG003|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
11362073|NCT02075411|EG000|Reported Event|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
11362074|NCT02075411|EG001|Reported Event|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
11362075|NCT02075411|EG002|Reported Event|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
11362076|NCT02075411|EG003|Reported Event|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
11362077|NCT02074904|BG000|Baseline|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
11362078|NCT02074904|BG001|Baseline|Placebo|"placebo~Placebo"
11362079|NCT02074904|BG002|Baseline|Total|Total of all reporting groups
11362080|NCT02074904|FG000|Participant Flow|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
11362081|NCT02074904|FG001|Participant Flow|Placebo|"placebo~Placebo"
11362082|NCT02074904|OG000|Outcome|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
11362083|NCT02074904|OG001|Outcome|Placebo|"placebo~Placebo"
11362084|NCT02074904|EG000|Reported Event|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
11362085|NCT02074904|EG001|Reported Event|Placebo|"placebo~Placebo"
10962650|NCT00867529|EG000|Reported Event|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11362086|NCT02084147|BG000|Baseline|PET-CT and PET-MRI|"Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.~positron emission tomography: Undergo PET~computed tomography: Undergo CT~magnetic resonance imaging: Undergo MRI"
11362087|NCT02084147|FG000|Participant Flow|PET-CT and PET-MRI|"Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.~positron emission tomography: Undergo PET~computed tomography: Undergo CT~magnetic resonance imaging: Undergo MRI"
11362088|NCT02084147|OG000|Outcome|PET-CT and PET-MRI|"Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.~positron emission tomography: Undergo PET~computed tomography: Undergo CT~magnetic resonance imaging: Undergo MRI"
11362089|NCT02084147|EG000|Reported Event|PET-CT and PET-MRI|"Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.~positron emission tomography: Undergo PET~computed tomography: Undergo CT~magnetic resonance imaging: Undergo MRI"
11362090|NCT02081183|BG000|Baseline|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
11362091|NCT02081183|BG001|Baseline|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
11362092|NCT02081183|BG002|Baseline|Total|Total of all reporting groups
11362093|NCT02081183|FG000|Participant Flow|Mycophenolate Mofetil (MMF), Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m^2), intravenously (IV) once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), tablets (or methylprednisolone IV), orally (PO); the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
11362094|NCT02081183|FG001|Participant Flow|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
11362095|NCT02081183|OG000|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
11362096|NCT02081183|OG001|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
11362097|NCT02081183|EG000|Reported Event|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
11362098|NCT02081183|EG001|Reported Event|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
11362099|NCT02067611|BG000|Baseline|X0002+Placebo|low dose, BID;middle dose, BID, or high dose, BID.
11362100|NCT02067611|FG000|Participant Flow|Group A|Low dose of X0002/placebo, twice per day
11362101|NCT02067611|FG001|Participant Flow|Group B|Middle dose of X0002/placebo, twice per day.
11362102|NCT02067611|FG002|Participant Flow|Group C|High dose of X0002/placebo, twice per day.
11362103|NCT02067611|OG000|Outcome|X0002|low dose, BID;middle dose, BID, or high dose, BID.
11362104|NCT02067611|OG001|Outcome|Placebo|Low dose, BID; Middle dose, BID; High dose BID
11362105|NCT02067611|OG000|Outcome|Group A|Low dose of X0002/placebo, twice per day
11362106|NCT02067611|OG001|Outcome|Group B|Middle dose of X0002/placebo, twice per day
11362107|NCT02067611|OG002|Outcome|Group C|High dose of X0002/placebo, twice per day
11362108|NCT02067611|OG001|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
11362109|NCT02067611|OG002|Outcome|Group C|High dose of X0002/placebo, twice per day.
11362110|NCT02067611|EG000|Reported Event|X0002/Placebo|low dose, BID;middle dose, BID, or high dose, BID.
11362111|NCT02067104|BG000|Baseline|Placebo|"receive 150 mg of oral placebo daily for a period of 2 months~Placebo: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months."
11362112|NCT02067104|BG001|Baseline|Vismodegib|"receive 150 mg of vismodegib daily for a period of 2 months~Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months."
11362113|NCT02067104|BG002|Baseline|Total|Total of all reporting groups
11362114|NCT02067104|FG000|Participant Flow|Placebo|"receive 150 mg of oral placebo daily for a period of 2 months~Placebo: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months."
11362115|NCT02067104|FG001|Participant Flow|Vismodegib|"receive 150 mg of vismodegib daily for a period of 2 months~Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months."
11362116|NCT02067104|OG000|Outcome|Placebo|"receive 150 mg of oral placebo daily for a period of 2 months~Placebo: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months."
11362117|NCT02067104|OG001|Outcome|Vismodegib|"receive 150 mg of vismodegib daily for a period of 2 months~Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months."
11362118|NCT02067104|EG000|Reported Event|Placebo|"receive 150 mg of oral placebo daily for a period of 2 months~Placebo: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months."
11362119|NCT02067104|EG001|Reported Event|Vismodegib|"receive 150 mg of vismodegib daily for a period of 2 months~Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months."
11362120|NCT02075021|BG000|Baseline|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
11362121|NCT02075021|FG000|Participant Flow|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
11362122|NCT02075021|OG000|Outcome|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
11362123|NCT02075021|EG000|Reported Event|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
11362124|NCT02057874|BG000|Baseline|Diagnostic (3T MRI)|"Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4-8 weeks, and 12 weeks after TACE. Each 3T MRI session will utilize a sequence of the following modalities: CEST-MRI, MT-MRI, DW-MRI, and DCE-MRI.~3 Tesla Magnetic Resonance Imaging: 3T MRI consists of a series of radiofrequency (RF) pulse sequences optimized for acquiring CEST-, MT-, DW-, and DCE-MRI data in one seamless imaging examination. For DCE, MR contrast agent will be intravenously administered.~Magnevist® (Intravenous (IV) administration of MRI contrast agent): For the acquisition of DCE-MR data, the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg) will be delivered intravenously by the MR technologist at a rate of 2 mL/sec (followed by a saline flush) via a power injector after the acquisition of a set of baseline dynamic scans. The entire sequence lasts approximately 8 minutes."
11362125|NCT02057874|FG000|Participant Flow|Diagnostic (3T MRI)|"Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4-8 weeks, and 12 weeks after TACE. Each 3T MRI session will utilize a sequence of the following modalities: CEST-MRI, MT-MRI, DW-MRI, and DCE-MRI.~3 Tesla Magnetic Resonance Imaging: 3T MRI consists of a series of radiofrequency (RF) pulse sequences optimized for acquiring CEST-, MT-, DW-, and DCE-MRI data in one seamless imaging examination. For DCE, MR contrast agent will be intravenously administered.~Magnevist® (Intravenous (IV) administration of MRI contrast agent): For the acquisition of DCE-MR data, the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg) will be delivered intravenously by the MR technologist at a rate of 2 mL/sec (followed by a saline flush) via a power injector after the acquisition of a set of baseline dynamic scans. The entire sequence lasts approximately 8 minutes."
11362126|NCT02057874|OG000|Outcome|Diagnostic (3T MRI)|"Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4-8 weeks, and 12 weeks after TACE. Each 3T MRI session will utilize a sequence of the following modalities: CEST-MRI, MT-MRI, DW-MRI, and DCE-MRI.~3 Tesla Magnetic Resonance Imaging: 3T MRI consists of a series of radiofrequency (RF) pulse sequences optimized for acquiring CEST-, MT-, DW-, and DCE-MRI data in one seamless imaging examination. For DCE, MR contrast agent will be intravenously administered.~Magnevist® (Intravenous (IV) administration of MRI contrast agent): For the acquisition of DCE-MR data, the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg) will be delivered intravenously by the MR technologist at a rate of 2 mL/sec (followed by a saline flush) via a power injector after the acquisition of a set of baseline dynamic scans. The entire sequence lasts approximately 8 minutes."
11362127|NCT02057874|OG000|Outcome|Diagnostic (3T MRI)|Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4...
11362128|NCT02057874|EG000|Reported Event|Diagnostic (3T MRI)|"Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4-8 weeks, and 12 weeks after TACE. Each 3T MRI session will utilize a sequence of the following modalities: CEST-MRI, MT-MRI, DW-MRI, and DCE-MRI.~3 Tesla Magnetic Resonance Imaging: 3T MRI consists of a series of radiofrequency (RF) pulse sequences optimized for acquiring CEST-, MT-, DW-, and DCE-MRI data in one seamless imaging examination. For DCE, MR contrast agent will be intravenously administered.~Magnevist® (Intravenous (IV) administration of MRI contrast agent): For the acquisition of DCE-MR data, the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg) will be delivered intravenously by the MR technologist at a rate of 2 mL/sec (followed by a saline flush) via a power injector after the acquisition of a set of baseline dynamic scans. The entire sequence lasts approximately 8 minutes."
11362129|NCT02057237|BG000|Baseline|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
10962651|NCT00867659|BG000|Baseline|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
10962652|NCT00867659|FG000|Participant Flow|Cetrotide Acetate|oocyte donors will receive 3 mg cetrotide acetate by a single injection on the day of oocyte retrieval. The incidence of OHSS will be assessed.
11239810|NCT02473614|OG001|Outcome|Conventional Hand Exercise Program|Participants first participated in conventional hand therapy for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, then they participated in the Music Glove therapy intervention for 3 weeks with a minimum of 3 hours per week.
11239811|NCT02473614|EG000|Reported Event|Music Glove|Participants participated in Music Glove therapy intervention 3 times a week for 3 weeks with a minimum of 3 hours per week.
11239812|NCT02473614|EG001|Reported Event|Conventional Hand Exercise Program|Participants participated in conventional hand therapy 3 times a week for 3 weeks with a minimum of 3 hours per week.
11239813|NCT02473640|BG000|Baseline|150 mg SYN-004|"There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of steady-state esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.~SYN-004~Esomeprazole~Ceftriaxone"
11239814|NCT02473640|FG000|Participant Flow|150 mg SYN-004|"There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.~SYN-004~Esomeprazole~Ceftriaxone"
11239815|NCT02473640|OG000|Outcome|150 mg SYN-004|There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.
11239816|NCT02473640|OG000|Outcome|150 mg SYN-004|"There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.~SYN-004~Esomeprazole~Ceftriaxone"
11239817|NCT02473640|EG000|Reported Event|Treatment Period 1|In Treatment Period 1 (ceftriaxone + SYN-004), all 15 enrolled subjects received 1 g ceftriaxone and 14 received both 150 mg doses of SYN-004. One subject received only one 150 mg dose of SYN-004. In Treatment Period 1, one subject was discontinued from the study prior to receiving the second dose of SYN-004 due to a stoma site hemorrhage. The subject did not continue into the run-in phase or Treatment Period 2.
11239818|NCT02473640|EG001|Reported Event|Run-in Period|Treatment Periods 1 and 2 were separated by a 5- to 7-day run-in phase, during which subjects self-administered 40 mg of esomeprazole once daily in the morning.
11239819|NCT02473640|EG002|Reported Event|Treatment Period 2|In Treatment Period 2, subjects received 2 oral doses of 150mg SYN-004 and 1g ceftriaxone in the presence of esomeprazole. In Treatment Period 2 (ceftriaxone + SYN-004 + esomeprazole), 14 subjects were exposed to ceftriaxone, SYN-004, and esomeprazole. One subject did not receive study drug according to protocol.
11239820|NCT02473718|BG000|Baseline|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
11239821|NCT02473718|BG001|Baseline|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
11239822|NCT02473718|BG002|Baseline|Total|Total of all reporting groups
11239823|NCT02473718|FG000|Participant Flow|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
11239824|NCT02473718|FG001|Participant Flow|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
11362130|NCT02057237|FG000|Participant Flow|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
11362131|NCT02057237|OG000|Outcome|Single Arm|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
11362132|NCT02057237|OG000|Outcome|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
11362133|NCT02057237|EG000|Reported Event|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
11362134|NCT02047747|BG000|Baseline|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
11362135|NCT02047747|FG000|Participant Flow|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
11362136|NCT02047747|OG000|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
11362137|NCT02047747|EG000|Reported Event|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
11362138|NCT02058537|BG000|Baseline|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
11362139|NCT02058537|FG000|Participant Flow|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
11362140|NCT02058537|OG000|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
11362141|NCT02058537|EG000|Reported Event|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
11362142|NCT02057276|BG000|Baseline|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
11362143|NCT02057276|BG001|Baseline|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
11362144|NCT02057276|BG002|Baseline|Total|Total of all reporting groups
11362145|NCT02057276|FG000|Participant Flow|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
11362146|NCT02057276|FG001|Participant Flow|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
11362147|NCT02057276|OG000|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
11362148|NCT02057276|OG001|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
11362149|NCT02057276|EG000|Reported Event|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
11362150|NCT02057276|EG001|Reported Event|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
11362151|NCT02038153|BG000|Baseline|Treatment (Lenalidomide)|"Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11362152|NCT02038153|FG000|Participant Flow|Treatment (Lenalidomide)|"Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11362153|NCT02038153|OG000|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11362154|NCT02038153|EG000|Reported Event|Treatment (Lenalidomide)|"Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
11362155|NCT02054910|BG000|Baseline|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
11362156|NCT02054910|BG001|Baseline|Sham|"A celiac plexus block will not be administered for pain management~Sham"
11362157|NCT02054910|BG002|Baseline|Total|Total of all reporting groups
11362158|NCT02054910|FG000|Participant Flow|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
11362159|NCT02054910|FG001|Participant Flow|Sham|"A celiac plexus block will not be administered for pain management~Sham"
11362160|NCT02054910|OG000|Outcome|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
11362161|NCT02054910|OG001|Outcome|Sham|"A celiac plexus block will not be administered for pain management~Sham"
11362162|NCT02054910|OG000|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
11362163|NCT02054910|OG001|Outcome|Sham|A celiac plexus block will not be administered for pain management
11362164|NCT02054910|EG000|Reported Event|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
11362165|NCT02054910|EG001|Reported Event|Sham|"A celiac plexus block will not be administered for pain management~Sham"
11362166|NCT02044302|BG000|Baseline|Blinded Group A|
10962653|NCT00867659|OG000|Outcome|Cetrotide Acetate|oocyte donors will receive a single injection of 3 mg cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
11362167|NCT02044302|BG001|Baseline|Blinded Group B|
11362168|NCT02044302|BG002|Baseline|Total|Total of all reporting groups
11362169|NCT02044302|FG000|Participant Flow|Blinded Group A|
11362170|NCT02044302|FG001|Participant Flow|Blinded Group B|
11362171|NCT02044302|OG000|Outcome|Terminated Cohort|
11362172|NCT02044302|EG000|Reported Event|Terminated Cohort|
11362173|NCT02046226|BG000|Baseline|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
11362174|NCT02046226|FG000|Participant Flow|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
11362175|NCT02046226|OG000|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing~Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
11362176|NCT02046226|OG001|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
11362177|NCT02046226|EG000|Reported Event|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated on each case report form.
11362178|NCT02044848|BG000|Baseline|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
11362179|NCT02044848|BG001|Baseline|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
11362180|NCT02044848|BG002|Baseline|Total|Total of all reporting groups
11362181|NCT02044848|FG000|Participant Flow|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
11362182|NCT02044848|FG001|Participant Flow|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
10962654|NCT00867659|OG000|Outcome|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
11362183|NCT02044848|OG000|Outcome|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
11362184|NCT02044848|OG001|Outcome|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
11362185|NCT02044848|EG000|Reported Event|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
11362186|NCT02044848|EG001|Reported Event|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
11362187|NCT02042950|BG000|Baseline|Carfilzomib|To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
11362188|NCT02042950|FG000|Participant Flow|Carfilzomib|To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
11362189|NCT02042950|OG000|Outcome|Carfilzomib|To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
11362190|NCT02042950|EG000|Reported Event|Carfilzomib|To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
11362191|NCT02048904|BG000|Baseline|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months~Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
11362192|NCT02048904|FG000|Participant Flow|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months~Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
11362193|NCT02048904|OG000|Outcome|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months~Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
11362194|NCT02048904|EG000|Reported Event|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months~Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
11362195|NCT02044822|BG000|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
11362196|NCT02044822|FG000|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
11362197|NCT02044822|OG000|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
11362198|NCT02044822|EG000|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
11362199|NCT02042924|BG000|Baseline|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
11362200|NCT02042924|FG000|Participant Flow|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
11362201|NCT02042924|OG000|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
11362202|NCT02042924|EG000|Reported Event|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
11362203|NCT02043860|BG000|Baseline|Total Marrow Irradiation|"Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.~Total Marrow Irradiation: Subjects in this trial will receive total body irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, 9Gy, or 12Gy.~Autologous Transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with escalating doses of total marrow irradiation prior to autologous stem cell rescue.~Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant.~Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days."
11362204|NCT02043860|FG000|Participant Flow|Total Marrow Irradiation|"Escalating doses of total marrow irradiation (3Gy(gray), 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.~Total Marrow Irradiation (TMI): Subjects in this trial will receive total body irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, 9Gy, or 12Gy.~Autologous Transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with escalating doses of total marrow irradiation prior to autologous stem cell rescue.~Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant.~Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days."
11362205|NCT02043860|OG000|Outcome|Cohort 1 TMI Dose 3Gy|Cohort 1 patients will receive standard high dose melphalan with autologous stem cell rescue. Plus TMI at a dose of 3Gy.
11362206|NCT02043860|EG000|Reported Event|Cohort 1 TMI Dose 3Gy|"This is a phase I trial. Patients will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). The dose of TMI will increase until the maximum tolerated dose (MTD) is reached. 3 participants will be in each cohort beginning with the lowest possible dose of 3Gy to a maximum dose of 12Gy.~All Cause Mortality Total 0/2 0%~Serious Adverse Events Total 0/2 0%~Adverse Events not including serious adverse events Total 2/2 100% Oral Mucositis 2/2 100% Diarrhea 2/2 100% Nausea 1/2 50% Non-productive cough 1/2 50% Rash to face and back 1/2 50% Throat pain 1/2 50% GI bleed 1/2 50%"
11362207|NCT02017522|BG000|Baseline|11C-PBR PET|"Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test we are evaluating from working and we will test the inflammatory cells in the blood for the same purpose.~All participants who proceed will have to return on at least one additional day to undergo a positron emission tomography (PET) scan similar to the scan your doctor ordered with 11C-PBR28 as the radiotracer. On either the same day or a different day, participants will also undergo a cardiac MRI."
11362208|NCT02017522|FG000|Participant Flow|11C-PBR PET|"Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test from working.~All participants who proceed will return on at least one additional day to undergo a positron emission tomography (PET) scan with 11C-PBR28 as the radiotracer to evaluate inflammation due to cardiac sarcoidosis."
11362209|NCT02017522|OG000|Outcome|11C-PBR PET|"Characters remaining: 623 Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test from working.~All participants who proceed will return on at least one additional day to undergo a positron emission tomography (PET) scan with 11C-PBR28 as the radiotracer to evaluate inflammation due to cardiac sarcoidosis."
11362210|NCT02017522|OG000|Outcome|11C-PBR PET|"Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test from working.~All participants who proceed will return on at least one additional day to undergo a positron emission tomography (PET) scan with 11C-PBR28 as the radiotracer to evaluate inflammation due to cardiac sarcoidosis."
11362211|NCT02017522|EG000|Reported Event|11C-PBR PET|"Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test being evaluated.~All participants who proceed will have to return on at least one additional day to undergo a positron emission tomography (PET) scan similar to the scan that their treating doctor ordered. 11C-PBR28 will be used as the radiotracer. On either the same day or a different day, a cardiac MRI will be performed."
11362212|NCT02030015|BG000|Baseline|Syner-G Therapy Regimen|"The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet, and daily treatment with orally-administered miglustat, for the duration of the 60-month study.~miglustat: The Syner-G therapy regimen includes treating with orally-administered miglustat for the duration of the 60-month study.~Ketogenic Diet: The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet for the 60-month duration of this study."
11362213|NCT02030015|FG000|Participant Flow|Syner-G Therapy Regimen|"The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet, and daily treatment with orally-administered miglustat, for the duration of the 60-month study.~miglustat: The Syner-G therapy regimen includes treating with orally-administered miglustat for the duration of the 60-month study.~Ketogenic Diet: The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet for the 60-month duration of this study."
11362214|NCT02030015|OG000|Outcome|Syner-G Therapy Regimen|"The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet, and daily treatment with orally-administered miglustat, for the duration of the 60-month study.~miglustat: The Syner-G therapy regimen includes treating with orally-administered miglustat for the duration of the 60-month study.~Ketogenic Diet: The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet for the 60-month duration of this study."
11362215|NCT02030015|EG000|Reported Event|Syner-G Therapy Regimen|"The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet, and daily treatment with orally-administered miglustat, for the duration of the 60-month study.~miglustat: The Syner-G therapy regimen includes treating with orally-administered miglustat for the duration of the 60-month study.~Ketogenic Diet: The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet for the 60-month duration of this study."
11362216|NCT02015663|BG000|Baseline|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
11362217|NCT02015663|BG001|Baseline|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
11362218|NCT02015663|BG002|Baseline|Total|Total of all reporting groups
11362219|NCT02015663|FG000|Participant Flow|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
11362220|NCT02015663|FG001|Participant Flow|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
11362221|NCT02015663|OG000|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
11362222|NCT02015663|OG001|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
11362223|NCT02015663|EG000|Reported Event|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
11362224|NCT02015663|EG001|Reported Event|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
11362225|NCT02015663|EG002|Reported Event|Total Events|
11362226|NCT02029846|BG000|Baseline|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
11362227|NCT02029846|BG001|Baseline|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
11362228|NCT02029846|BG002|Baseline|Total|Total of all reporting groups
11362229|NCT02029846|FG000|Participant Flow|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
11362230|NCT02029846|FG001|Participant Flow|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
11362231|NCT02029846|OG000|Outcome|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
11362232|NCT02029846|OG001|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
11362233|NCT02029846|EG000|Reported Event|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
11362234|NCT02029846|EG001|Reported Event|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
11362235|NCT02027272|BG000|Baseline|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
11362236|NCT02027272|BG001|Baseline|Placebo|Placebo, 2 doses, 12 hours apart
11362237|NCT02027272|BG002|Baseline|Total|Total of all reporting groups
11362238|NCT02027272|FG000|Participant Flow|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
11362239|NCT02027272|FG001|Participant Flow|Placebo|Placebo, 2 doses, 12 hours apart
11362240|NCT02027272|OG000|Outcome|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
11362241|NCT02027272|OG001|Outcome|Placebo|Placebo, 2 doses, 12 hours apart
11362242|NCT02027272|EG000|Reported Event|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
11362243|NCT02027272|EG001|Reported Event|Placebo|Placebo, 2 doses, 12 hours apart
11362244|NCT02012608|BG000|Baseline|Glutamine|"Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day~Glutamine: Oral glutamine for subjects undergoing breast conserving therapy"
11362245|NCT02012608|BG001|Baseline|Placebo|"Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day~Placebo: For subjects undergoing breast conserving therapy"
11362246|NCT02012608|BG002|Baseline|Total|Total of all reporting groups
11362247|NCT02012608|FG000|Participant Flow|Glutamine|"Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day~Glutamine: Oral glutamine for subjects undergoing breast conserving therapy"
11362248|NCT02012608|FG001|Participant Flow|Placebo|"Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day~Placebo: For subjects undergoing breast conserving therapy"
11362249|NCT02012608|OG000|Outcome|Glutamine|"Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day~Glutamine: Oral glutamine for subjects undergoing breast conserving therapy"
11362250|NCT02012608|OG001|Outcome|Placebo|"Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day~Placebo: For subjects undergoing breast conserving therapy"
11362251|NCT02012608|EG000|Reported Event|Glutamine|"Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day~Glutamine: Oral glutamine for subjects undergoing breast conserving therapy"
11362252|NCT02012608|EG001|Reported Event|Placebo|"Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day~Placebo: For subjects undergoing breast conserving therapy"
11362253|NCT02017379|BG000|Baseline|Erythromycin|"Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure~Erythromycin"
11362254|NCT02017379|BG001|Baseline|Metoclopromide|"Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy~Metoclopromide"
11362255|NCT02017379|BG002|Baseline|Control|no medications will be given prior to endoscopy
11362256|NCT02017379|BG003|Baseline|Total|Total of all reporting groups
11362257|NCT02017379|FG000|Participant Flow|Erythromycin|"Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure~Erythromycin"
11362258|NCT02017379|FG001|Participant Flow|Metoclopromide|"Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy~Metoclopromide"
11362259|NCT02017379|FG002|Participant Flow|Control|no medications will be given prior to endoscopy
11362260|NCT02017379|OG000|Outcome|Erythromycin|"Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure~Erythromycin"
11362261|NCT02017379|OG001|Outcome|Metoclopromide|"Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy~Metoclopromide"
11362262|NCT02017379|OG002|Outcome|Control|no medications will be given prior to endoscopy
11362263|NCT02017379|EG000|Reported Event|Erythromycin|"Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure~Erythromycin"
11362264|NCT02017379|EG001|Reported Event|Metoclopromide|"Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy~Metoclopromide"
11362265|NCT02017379|EG002|Reported Event|Control|no medications will be given prior to endoscopy
11362266|NCT02011542|BG000|Baseline|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
11362267|NCT02011542|FG000|Participant Flow|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
11362268|NCT02011542|OG000|Outcome|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
11362269|NCT02011542|EG000|Reported Event|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
11362270|NCT02008370|BG000|Baseline|Exparel Infiltration|"Exparel infiltrated into wound and chest tube sites~Exparel infiltration: Exparel infiltrated into wound and chest tube sites"
11362271|NCT02008370|FG000|Participant Flow|Exparel Infiltration|"Exparel infiltrated into wound and chest tube sites~Exparel infiltration: Exparel infiltrated into wound and chest tube sites"
11362272|NCT02008370|OG000|Outcome|Exparel Infiltration|"Exparel infiltrated into wound and chest tube sites~Exparel infiltration: Exparel infiltrated into wound and chest tube sites"
11362273|NCT02008370|EG000|Reported Event|Exparel Infiltration|"Exparel infiltrated into wound and chest tube sites~Exparel infiltration: Exparel infiltrated into wound and chest tube sites"
11362274|NCT02009982|BG000|Baseline|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
11362275|NCT02009982|BG001|Baseline|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
11362276|NCT02009982|BG002|Baseline|Total|Total of all reporting groups
11362277|NCT02009982|FG000|Participant Flow|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
11362278|NCT02009982|FG001|Participant Flow|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
11362279|NCT02009982|OG000|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
11362280|NCT02009982|OG001|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
11362281|NCT02009982|EG000|Reported Event|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
11362282|NCT02009982|EG001|Reported Event|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
11362283|NCT02013414|BG000|Baseline|Targeted Biopsy and Template Biopsy|Study participants with abnormal FACBC PET-CT scans received a fluciclovine PET ultrasound fusion targeted biopsy and a template (standard of care) biopsy to test the feasibility of targeted biopsies for detecting recurrent prostate cancer.
11362284|NCT02013414|FG000|Participant Flow|Targeted Biopsy and Template Biopsy|Study participants with abnormal FACBC PET-CT scans received a fluciclovine PET ultrasound fusion targeted biopsy and a template (standard of care) biopsy to test the feasibility of targeted biopsies for detecting recurrent prostate cancer.
11362285|NCT02013414|OG000|Outcome|Targeted Biopsy|Fluciclovine defined targets were biopsied using the 3-D visualization and navigation platform to guide the biopsy needle and record its path
11362286|NCT02013414|OG001|Outcome|Standard Biopsy|The standard transrectal ultrasound guided biopsy collects 2 cores per region (when possible) from 6 standard regions of the prostate.
11362287|NCT02013414|EG000|Reported Event|Targeted Biopsy|Fluciclovine defined targets were biopsied using the 3-D visualization and navigation platform to guide the biopsy needle and record its path
11362288|NCT02013414|EG001|Reported Event|Standard Biopsy|The standard transrectal ultrasound guided biopsy collects 2 cores per region (when possible) from 6 standard regions of the prostate.
11362289|NCT02005445|BG000|Baseline|CPAP|"Continuous positive airway pressure~CPAP: Continuous positive airway pressure"
11362290|NCT02005445|BG001|Baseline|HLSE|"Healthy living and sleep education~HLSE: Healthy living and sleep education"
11362291|NCT02005445|BG002|Baseline|Total|Total of all reporting groups
11362292|NCT02005445|FG000|Participant Flow|CPAP|"Continuous positive airway pressure~CPAP: Continuous positive airway pressure"
11362293|NCT02005445|FG001|Participant Flow|HLSE|"Healthy living and sleep education~HLSE: Healthy living and sleep education"
11362294|NCT02005445|OG000|Outcome|CPAP|"Continuous positive airway pressure~CPAP: Continuous positive airway pressure"
11362295|NCT02005445|OG001|Outcome|HLSE|"Healthy living and sleep education~HLSE: Healthy living and sleep education"
11362296|NCT02005445|EG000|Reported Event|CPAP|"Continuous positive airway pressure~CPAP: Continuous positive airway pressure"
11362297|NCT02005445|EG001|Reported Event|HLSE|"Healthy living and sleep education~HLSE: Healthy living and sleep education"
11362298|NCT02020837|BG000|Baseline|Lymphaticovenous Micro-Anastomosis|Lymphaticovenous Micro-Anastomosis
11362299|NCT02020837|FG000|Participant Flow|Lymphaticovenous Micro-Anastomosis|Lymphaticovenous Micro-Anastomosis
11362300|NCT02020837|OG000|Outcome|Lymphaticovenous Micro-Anastomosis|Lymphaticovenous Micro-Anastomosis
11362301|NCT02020837|EG000|Reported Event|Lymphaticovenous Micro-Anastomosis|Lymphaticovenous Micro-Anastomosis
11362302|NCT02015910|BG000|Baseline|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
11362303|NCT02015910|BG001|Baseline|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
11362304|NCT02015910|BG002|Baseline|Total|Total of all reporting groups
11362305|NCT02015910|FG000|Participant Flow|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
11362306|NCT02015910|FG001|Participant Flow|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
11362307|NCT02015910|OG000|Outcome|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
11362308|NCT02015910|OG001|Outcome|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
11362309|NCT02015910|EG000|Reported Event|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
11362310|NCT02015910|EG001|Reported Event|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
11362311|NCT02006927|BG000|Baseline|Nerve Stimulation|"Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy~Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy"
11362312|NCT02006927|FG000|Participant Flow|Nerve Stimulation|"Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy~Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy"
11362313|NCT02006927|OG000|Outcome|Nerve Stimulation|"Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy~Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy"
11362314|NCT02006927|EG000|Reported Event|Nerve Stimulation|"Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy~Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy"
11362315|NCT01996982|BG000|Baseline|Device|"CCS Device application: No data are available for this study as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available.~CCS Device: Core Cooling System Device: : No data are available for this study as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available."
11362316|NCT01996982|FG000|Participant Flow|Device|"CCS Device application~CCS Device: Core Cooling System Device"
11362317|NCT01996982|OG000|Outcome|Device|"CCS Device application~CCS Device: Core Cooling System Device"
11362318|NCT01996982|EG000|Reported Event|Device|"CCS Device application~CCS Device: Core Cooling System Device"
11362319|NCT02006407|BG000|Baseline|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
11362320|NCT02006407|FG000|Participant Flow|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
11362321|NCT02006407|OG000|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
11362322|NCT02006407|EG000|Reported Event|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
11362323|NCT01986751|BG000|Baseline|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).~Clonidine~ropivacaine"
11362324|NCT01986751|BG001|Baseline|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine~ropivacaine"
11362325|NCT01986751|BG002|Baseline|Total|Total of all reporting groups
11362326|NCT01986751|FG000|Participant Flow|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).~Clonidine~ropivacaine"
11362327|NCT01986751|FG001|Participant Flow|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine~ropivacaine"
11362328|NCT01986751|OG000|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
11362329|NCT01986751|OG001|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
11362330|NCT01986751|OG000|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
11362331|NCT01986751|OG001|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
11362332|NCT01986751|OG000|Outcome|Clonidine and Ropivacaine|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
11362333|NCT01986751|OG001|Outcome|Ropivacaine|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
11362334|NCT01986751|EG000|Reported Event|Clonidine and Ropivacaine (Study Group)|A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
11362335|NCT01986751|EG001|Reported Event|Ropivacaine (Control)|Standard saphenous nerve block (adductor canal approach) will be performed using 20 ml of 0.5% ropivacaine
11362336|NCT01996410|BG000|Baseline|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
10962655|NCT00867659|EG000|Reported Event|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
11239825|NCT02473718|OG000|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
11239826|NCT02473718|OG001|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
11239827|NCT02473718|EG000|Reported Event|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
11239828|NCT02473718|EG001|Reported Event|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
11239829|NCT02473783|BG000|Baseline|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
11239830|NCT02473783|BG001|Baseline|Healthy Control Group|All healthy subjects (N=17) had only basal I-123-ADAM SPECT scanning.
11239831|NCT02473783|BG002|Baseline|Total|Total of all reporting groups
11239832|NCT02473783|FG000|Participant Flow|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
11239833|NCT02473783|FG001|Participant Flow|Healthy Control Group|All healthy subjects had only basal I-123-ADAM SPECT scanning
11239834|NCT02473783|OG000|Outcome|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
11239835|NCT02473783|OG000|Outcome|Treatment Group|The subjects with major depressive disorder were assessed with Hamilton Depression Rating Scale (HAM-D) before and after 6 weeks of Sertraline HCl treatment.
11239836|NCT02473783|OG001|Outcome|Healthy Control Group|All healthy subjects had only basal I-123-ADAM SPECT scanning.
11362337|NCT01996410|BG001|Baseline|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362338|NCT01996410|BG002|Baseline|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362339|NCT01996410|BG003|Baseline|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362340|NCT01996410|BG004|Baseline|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362341|NCT01996410|BG005|Baseline|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362342|NCT01996410|BG006|Baseline|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362343|NCT01996410|BG007|Baseline|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362344|NCT01996410|BG008|Baseline|Total|Total of all reporting groups
11362345|NCT01996410|FG000|Participant Flow|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362346|NCT01996410|FG001|Participant Flow|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362347|NCT01996410|FG002|Participant Flow|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362348|NCT01996410|FG003|Participant Flow|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362349|NCT01996410|FG004|Participant Flow|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362350|NCT01996410|FG005|Participant Flow|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362351|NCT01996410|FG006|Participant Flow|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362352|NCT01996410|FG007|Participant Flow|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362353|NCT01996410|OG000|Outcome|Acupuncture|
11362354|NCT01996410|OG001|Outcome|Standard of Care- No Acupuncture|
11362355|NCT01996410|EG000|Reported Event|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362356|NCT01996410|EG001|Reported Event|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362357|NCT01996410|EG002|Reported Event|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362358|NCT01996410|EG003|Reported Event|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362359|NCT01996410|EG004|Reported Event|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362360|NCT01996410|EG005|Reported Event|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
10962656|NCT00867789|BG000|Baseline|Trimethoprim-sulfamethaxazole|"Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)~Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)"
11336611|NCT03569098|EG005|Reported Event|Open-Label Treatment Period (Cycle 3): Dysport 500 U|"On Cycle 3 Day 1 in the open-label treatment period, all participants who met retreatment criteria received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.~The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle."
11336612|NCT03569202|BG000|Baseline|Emulsion Eye Drops|"Daily treatment with Piiloset Trehalose Emulsion Eye Drops~Results are reported for Part 3 only:~Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days"
11336613|NCT03569202|BG001|Baseline|Control Eye Drops|"Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)~Results are reported for Part 3 only:~Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days"
11336614|NCT03569202|BG002|Baseline|Total|Total of all reporting groups
11336615|NCT03569202|FG000|Participant Flow|Emulsion Eye Drops|"Daily treatment with Piiloset Trehalose Emulsion Eye Drops~Piiloset Trehalose Emulsion Eye Drops: Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops~Part 1: on one eye 4 times during one day~Part 2: on one randomized eye 3 times a day for 10 days~Part 3: on both eyes 3 times a day for 30 days"
11336616|NCT03569202|FG001|Participant Flow|Control Eye Drops|"Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)~Control Eye Drops: Topical application of preservative-free multidose Hyaluronic Acid Eye Drops~Part 1: not used~Part 2: on randomized contralateral eye 3 times a day for 10 days~Part 3: on both eyes 3 times a day for 30 days"
11336617|NCT03569202|OG000|Outcome|Emulsion Eye Drops|"Daily treatment with Piiloset Trehalose Emulsion Eye Drops~Results are reported for Part 3 only:~Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days"
11336618|NCT03569202|OG001|Outcome|Control Eye Drops|"Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)~Results are reported for Part 3 only:~Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days"
11336619|NCT03569202|EG000|Reported Event|Emulsion Eye Drops|"Daily treatment with Piiloset Trehalose Emulsion Eye Drops~Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Piiloset Trehalose Emulsion Eye Drops at least once and from whom at least one safety measurement was obtained after randomization."
11336620|NCT03569202|EG001|Reported Event|Control Eye Drops|"Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)~Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Hyaluronic Acid Eye Drops at least once and from whom at least one safety measurement was obtained after randomization."
11336621|NCT03569371|BG000|Baseline|INCB054707|Participants were treated with 15 mg QD of INCB054707 orally.
11336622|NCT03569371|FG000|Participant Flow|INCB054707|Participants were treated with 15 mg QD of INCB054707 orally.
11336623|NCT03569371|OG000|Outcome|INCB054707|Participants were treated with 15 mg QD of INCB054707 orally.
11336624|NCT03569371|EG000|Reported Event|INCB054707|Participants were treated with 15 mg QD of INCB054707 orally.
11336625|NCT03569397|BG000|Baseline|Music Therapy|Patients will be administered music therapy during the operation.
11336626|NCT03569397|BG001|Baseline|Non-Music Therapy|No headphones or music therapy during the operation
11336627|NCT03569397|BG002|Baseline|Total|Total of all reporting groups
11336628|NCT03569397|FG000|Participant Flow|Music Therapy|Patients will be administered music therapy during the operation.
11336629|NCT03569397|FG001|Participant Flow|Non-Music Therapy|No headphones or music therapy during the operation
11336630|NCT03569397|OG000|Outcome|Music Therapy|Patients will be administered music therapy during the operation.
11336631|NCT03569397|EG000|Reported Event|Music Therapy|Patients will be administered music therapy during the operation.
11336632|NCT03569397|EG001|Reported Event|Non-Music Therapy|No headphones or music therapy during the operation
11336633|NCT03569618|BG000|Baseline|AKL-T03|Tablet-based game aimed at improving processing speed and attention.
11336634|NCT03569618|BG001|Baseline|AKL-T09|Control, tablet-based word finding game
11336635|NCT03569618|BG002|Baseline|Total|Total of all reporting groups
11336636|NCT03569618|FG000|Participant Flow|AKL-T03|Tablet-based game aimed at improving processing speed and attention.
11336637|NCT03569618|FG001|Participant Flow|AKL-T09|Control, tablet-based word-finding game
11336638|NCT03569618|OG000|Outcome|AKL-T03|Tablet-based game aimed at improving processing speed and attention.
11336639|NCT03569618|OG001|Outcome|AKL-T09|Control, tablet-based word-finding game
11336640|NCT03569618|OG001|Outcome|AKL-T09|Control, tablet-based word finding game
11336641|NCT03569618|EG000|Reported Event|AKL-T03|Tablet-based game aimed at improving processing speed and attention.
11336642|NCT03569618|EG001|Reported Event|AKL-T09|Control, tablet-based word-finding game
11336643|NCT03569748|BG000|Baseline|IQOS|"HEAT NOT BURN REDUCED RISK PRODUCT~IQOS: IQOS USE FOR 12 WEEKS"
11336644|NCT03569748|BG001|Baseline|E-CIG|"ELECTRONIC CIGARETTE REDUCED RISK PRODUCT~E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS"
11336645|NCT03569748|BG002|Baseline|Total|Total of all reporting groups
11336646|NCT03569748|FG000|Participant Flow|IQOS|"HEAT NOT BURN REDUCED RISK PRODUCT~IQOS: IQOS USE FOR 12 WEEKS"
11336647|NCT03569748|FG001|Participant Flow|E-CIG|"ELECTRONIC CIGARETTE REDUCED RISK PRODUCT~E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS"
11336648|NCT03569748|OG000|Outcome|IQOS|"HEAT NOT BURN REDUCED RISK PRODUCT~IQOS: IQOS USE FOR 12 WEEKS"
11336649|NCT03569748|OG001|Outcome|E-CIG|"ELECTRONIC CIGARETTE REDUCED RISK PRODUCT~E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS"
11336650|NCT03569748|OG000|Outcome|IQOS|4 PARTICIPANTS WITHOUT ADHERENCE IN IQOS GROUP
11336651|NCT03569748|OG001|Outcome|E-CIG|19 PARTICIPANTS WITHOUT ADHERENCE IN E-CIG GROUP
11336652|NCT03569748|OG000|Outcome|IQOS|MEAN CHANGES AT FINAL VISIT (WEEK 12) FROM BASELINE IN MCEQ SCORES: O.73
11336653|NCT03569748|OG001|Outcome|E-CIG|MEAN CHANGES AT FINAL VISIT (WEEK 12) FROM BASELINE IN MCEQ SCORES: -O.17
11188583|NCT02114684|OG000|Outcome|Moxifloxacin|"A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.~The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.~Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38-54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38-54 and ≥55 kg, respectively."
11188584|NCT02114684|OG001|Outcome|Control|"An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.~Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).~During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid."
11188585|NCT02114684|OG000|Outcome|HIV Positive, Moxifloxacin|HIV negative participants based on HIV status at study enrollment, who were assigned to the Moxifloxacin group
11188586|NCT02114684|OG001|Outcome|HIV Positive, Control|HIV positive participants based on HIV status at study enrollment, who were assigned to the control group
11188587|NCT02114684|OG002|Outcome|HIV Negative, Moxifloxacin|HIV negative participants based on HIV status at study enrollment, who were assigned to the Moxifloxacin arm
11188588|NCT02114684|OG003|Outcome|HIV Negative, Control|HIV negative participants based on HIV status at study enrollment, who were assigned to the control group
11188589|NCT02114684|EG000|Reported Event|Moxifloxacin|"A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.~The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.~Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38-54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38-54 and ≥55 kg, respectively."
11188590|NCT02114684|EG001|Reported Event|Control|"An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.~Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).~During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid."
11188591|NCT02114879|BG000|Baseline|Standard of Care Rehabilitation|Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
11188592|NCT02114879|BG001|Baseline|Enhanced Medical Rehabilitation|Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
11188593|NCT02114879|BG002|Baseline|Total|Total of all reporting groups
11188594|NCT02114879|FG000|Participant Flow|Standard of Care Rehabilitation|Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
11188595|NCT02114879|FG001|Participant Flow|Enhanced Medical Rehabilitation|Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
11188596|NCT02114879|OG000|Outcome|Standard of Care Rehabilitation|Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
11188597|NCT02114879|OG001|Outcome|Enhanced Medical Rehabilitation|Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
11188598|NCT02114879|EG000|Reported Event|Standard of Care Rehabilitation|Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
11188599|NCT02114879|EG001|Reported Event|Enhanced Medical Rehabilitation|Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
11188600|NCT02114892|BG000|Baseline|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
11188601|NCT02114892|BG001|Baseline|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
11188602|NCT02114892|BG002|Baseline|Total|Total of all reporting groups
11188603|NCT02114892|FG000|Participant Flow|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
11336654|NCT03569748|OG000|Outcome|IQOS|"at v6 (week 12) mean(sd) eCO: 8.2 (8.0)~at v6 (week 12) mean(sd) Step Test VoMax: 44.7 (28.7)"
11188604|NCT02114892|FG001|Participant Flow|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
11188605|NCT02114892|OG000|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
11188606|NCT02114892|OG001|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
11188607|NCT02114892|EG000|Reported Event|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
11188608|NCT02114892|EG001|Reported Event|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
11191685|NCT02132949|FG001|Participant Flow|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
11191686|NCT02132949|OG000|Outcome|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
11191687|NCT02132949|OG001|Outcome|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
11191688|NCT02132949|EG000|Reported Event|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
11191689|NCT02132949|EG001|Reported Event|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
11191690|NCT02133001|BG000|Baseline|Placebo|Participants received intranasal placebo (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) administered twice weekly for 4 weeks on days 1, 4, 8, 11, 15, 18, 22, and 25 along with standard of care antidepressant treatment (determined by the treating physician based on clinical judgment) on Day 1 and continued for the duration of the double-blind treatment phase.
11336655|NCT03569748|OG001|Outcome|E-CIG|"at v6 (week 12) mean(sd) eCO: 10.1 (11.3)~at v6 (week 12) mean(sd) Step Test VoMax: 50.9 (31.9)"
11336656|NCT03569748|EG000|Reported Event|IQOS|"HEAT NOT BURN REDUCED RISK PRODUCT~IQOS: IQOS USE FOR 12 WEEKS"
11336657|NCT03569748|EG001|Reported Event|E-CIG|"ELECTRONIC CIGARETTE REDUCED RISK PRODUCT~E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS"
11188609|NCT02114931|BG000|Baseline|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
11188610|NCT02114931|BG001|Baseline|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
11188611|NCT02114931|BG002|Baseline|Total|Total of all reporting groups
11188612|NCT02114931|FG000|Participant Flow|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
11188613|NCT02114931|FG001|Participant Flow|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
11188614|NCT02114931|OG000|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
11188615|NCT02114931|OG001|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
11188616|NCT02114931|EG000|Reported Event|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
11188617|NCT02114931|EG001|Reported Event|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
11362361|NCT01996410|EG006|Reported Event|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11362362|NCT01996410|EG007|Reported Event|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
11188618|NCT02115048|BG000|Baseline|Arm A|Letrozole 2.5 mg
11188619|NCT02115048|BG001|Baseline|Arm B|Letrozole 2.5 mg + Afatinib 30 mg
11188620|NCT02115048|BG002|Baseline|Total|Total of all reporting groups
11188621|NCT02115048|FG000|Participant Flow|Arm A|Letrozole 2.5 mg
11188622|NCT02115048|FG001|Participant Flow|Arm B|Letrozole 2.5 mg + Afatinib 30 mg
11188623|NCT02115048|OG000|Outcome|Arm A|Letrozole 2.5 mg
11188624|NCT02115048|OG001|Outcome|Arm B|Letrozole 2.5 mg + Afatinib 30 mg
11188625|NCT02115048|EG000|Reported Event|Arm A|Letrozole 2.5 mg
11188626|NCT02115048|EG001|Reported Event|Arm B|Letrozole 2.5 mg + Afatinib 30 mg
11188627|NCT02115113|BG000|Baseline|Total Enrolled at run-in|Participants, who had a successful liver transplantation and who had initiated a tacrolimus-based regimen and possible induction therapy or intravenous (i.v.) steroids according to local practice, were enrolled into the study 4 weeks (+/- 7 days) after transplantation and started on a everolimus-based regimen with tacrolimus minimization up until 5 months post transplantation.
11188628|NCT02115113|FG000|Participant Flow|Group A (Tacrolimus Elimination Arm)|At study start, participants received an Everolimus starting dose of 1.0 mg twice daily in combination with Tacrolimus. Tacrolimus was administered as per center practice. Thereafter, Everolimus doses were adjusted to achieve Everolimus C-0h blood trough levels between 3-8 ng/mL by week 1 after drug initiation until 5 months after transplant. At 5 months after transplant, Everolimus doses were adjusted to achieve C-0h blood trough level target ranges 6-10 ng/mL. Tacrolimus withdrawal was completed by 6 months after transplant.
11188629|NCT02115113|FG001|Participant Flow|Group B (Tacrolimus Minimization Arm)|At study start, participants received an Everolimus starting dose of 1.0 mg twice daily in combination with Tacrolimus. Tacrolimus was administered as per center practice. Thereafter, Everolimus doses were adjusted to achieve Everolimus C-0h blood trough levels between 3-8 ng/mL by week 1 after drug initiation until 5 months after transplant. At 5 months after transplant, Everolimus doses continued to be adjusted to achieve C-0h blood trough level target ranges 3-8 ng/mL and Tacorlimus doses were adjusted to achieve C-0h blood trough level target ranges 3-5 ng/mL.
11188630|NCT02115113|FG002|Participant Flow|Total Enrolled at run-in|Participants, who had a successful liver transplantation and who had initiated a tacrolimus-based regimen and possible induction therapy or intravenous (i.v.) steroids according to local practice, were enrolled into the study 4 weeks (+/- 7 days) after transplantation and started on a everolimus-based regimen with tacrolimus minimization up until 5 months post transplantation.
11188631|NCT02115113|OG000|Outcome|Group A (Tacrolimus Elimination Arm)|At study start, participants received an Everolimus starting dose of 1.0 mg twice daily in combination with Tacrolimus. Tacrolimus was administered as per center practice. Thereafter, Everolimus doses were adjusted to achieve Everolimus C-0h blood trough levels between 3-8 ng/mL by week 1 after drug initiation until 5 months after transplant. At 5 months after transplant, Everolimus doses were adjusted to achieve C-0h blood trough level target ranges 6-10 ng/mL. Tacrolimus withdrawal was completed by 6 months after transplant.
11188632|NCT02115113|OG001|Outcome|Group B (Tacrolimus Minimization Arm)|At study start, participants received an Everolimus starting dose of 1.0 mg twice daily in combination with Tacrolimus. Tacrolimus was administered as per center practice. Thereafter, Everolimus doses were adjusted to achieve Everolimus C-0h blood trough levels between 3-8 ng/mL by week 1 after drug initiation until 5 months after transplant. At 5 months after transplant, Everolimus doses continued to be adjusted to achieve C-0h blood trough level target ranges 3-8 ng/mL and Tacorlimus doses were adjusted to achieve C-0h blood trough level target ranges 3-5 ng/mL.
11362363|NCT01996852|BG000|Baseline|Standard ED Care|"Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)~sildenafil citrate: 100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed.~To increase external validity, participants will be given the choice of using Sildenafil in the study.~Vacuum Constriction Device: The medical treatment entails a 10-minute daily use of VCD (pump).~The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call."
11362364|NCT01996852|BG001|Baseline|Standard ED Care + Cognitive-Behavioral Intervention|"standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings~Cognitive-behavioral Meetings: The cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support.~Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review.~Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min"
11362365|NCT01996852|BG002|Baseline|Usual Care (UC)|Study participants will not receive any study intervention, but will continue with standard care.
11362366|NCT01996852|BG003|Baseline|Total|Total of all reporting groups
11362367|NCT01996852|FG000|Participant Flow|Standard ED Care|"Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)~sildenafil citrate: 100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed.~To increase external validity, participants will be given the choice of using Sildenafil in the study.~Vacuum Constriction Device: The medical treatment entails a 10-minute daily use of VCD (pump).~The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call."
11362368|NCT01996852|FG001|Participant Flow|Standard ED Care + Cognitive-Behavioral Intervention|"standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings~Cognitive-behavioral Meetings: The cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support.~Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review.~Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min."
11362369|NCT01996852|FG002|Participant Flow|Usual Care (UC)|Study participants will not receive any study intervention, but will continue with standard care.
11362370|NCT01996852|OG000|Outcome|Standard ED Care|"Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)~sildenafil citrate: 100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed.~To increase external validity, participants will be given the choice of using Sildenafil in the study.~Vacuum Constriction Device: The medical treatment entails a 10-minute daily use of VCD (pump).~The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call."
11362371|NCT01996852|OG001|Outcome|Standard ED Care + Cognitive-Behavioral Intervention|"standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings~Cognitive-behavioral Meetings: The cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support.~Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review.~Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min."
11362372|NCT01996852|OG002|Outcome|Usual Care (UC)|Study participants will not receive any study intervention, but will continue with standard care.
10962657|NCT00867789|BG001|Baseline|Sugar Pill|"Incision and drainage of the abscess and treatment with oral placebo (100 patients)~Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder."
10962658|NCT00867789|BG002|Baseline|Total|Total of all reporting groups
11362373|NCT01996852|EG000|Reported Event|Standard ED Care|"Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)~sildenafil citrate: 100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed.~To increase external validity, participants will be given the choice of using Sildenafil in the study.~Vacuum Constriction Device: The medical treatment entails a 10-minute daily use of VCD (pump).~The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call."
11362374|NCT01996852|EG001|Reported Event|Standard ED Care + Cognitive-Behavioral Intervention|"standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings~Cognitive-behavioral Meetings: The cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support.~Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review.~Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min."
11362375|NCT01996852|EG002|Reported Event|Usual Care (UC)|Study participants will not receive any study intervention, but will continue with standard care.
11362376|NCT01997567|BG000|Baseline|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
11362377|NCT01997567|BG001|Baseline|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
11362378|NCT01997567|BG002|Baseline|Total|Total of all reporting groups
11362379|NCT01997567|FG000|Participant Flow|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
11362380|NCT01997567|FG001|Participant Flow|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
11362381|NCT01997567|OG000|Outcome|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
11362382|NCT01997567|OG001|Outcome|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
11362383|NCT01997567|EG000|Reported Event|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
11362384|NCT01997567|EG001|Reported Event|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
11362385|NCT01977729|BG000|Baseline|All Study Participants|
11362386|NCT01977729|FG000|Participant Flow|All Participants|Only one participant was recruited, but never randomized.
11362387|NCT01977729|OG000|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
11362388|NCT01977729|OG001|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
11362389|NCT01977729|EG000|Reported Event|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
11362390|NCT01977729|EG001|Reported Event|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
11362391|NCT01973062|BG000|Baseline|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|"Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~yttrium Y 90 ibritumomab tiuxetan: Given IV"
11362392|NCT01973062|FG000|Participant Flow|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|"Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~yttrium Y 90 ibritumomab tiuxetan: Given IV"
11362393|NCT01973062|OG000|Outcome|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|"Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~yttrium Y 90 ibritumomab tiuxetan: Given IV"
11362394|NCT01973062|EG000|Reported Event|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|"Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~yttrium Y 90 ibritumomab tiuxetan: Given IV"
11362395|NCT01982253|BG000|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
11362396|NCT01982253|BG001|Baseline|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
11362397|NCT01982253|BG002|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
11362398|NCT01982253|BG003|Baseline|Total|Total of all reporting groups
11362399|NCT01982253|FG000|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
11362400|NCT01982253|FG001|Participant Flow|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
11362401|NCT01982253|FG002|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
11362402|NCT01982253|OG000|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
11362403|NCT01982253|OG001|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
11362404|NCT01982253|OG002|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
11362405|NCT01982253|EG000|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
10962659|NCT00867789|FG000|Participant Flow|Trimethoprim-sulfamethaxazole|"Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)~Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)"
11362406|NCT01982253|EG001|Reported Event|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
11362407|NCT01982253|EG002|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
11362408|NCT01984268|BG000|Baseline|Entire Study|The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
11362409|NCT01984268|FG000|Participant Flow|Entire Study|The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
11362410|NCT01984268|OG000|Outcome|Entire Study|The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
11362411|NCT01984268|EG000|Reported Event|Entire Study|The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
11362412|NCT01974284|BG000|Baseline|Percutaneous Ethanol Ablation|"The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.~percutaneous ethanol ablation: The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia."
11362413|NCT01974284|FG000|Participant Flow|Percutaneous Ethanol Ablation|"The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.~percutaneous ethanol ablation: The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia."
11362414|NCT01974284|OG000|Outcome|Percutaneous Ethanol Ablation|"The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.~percutaneous ethanol ablation: The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia."
11362415|NCT01974284|EG000|Reported Event|Percutaneous Ethanol Ablation|"The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.~percutaneous ethanol ablation: The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia."
11362416|NCT01971853|BG000|Baseline|Oral Placebo|"an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen~oral placebo: Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen"
11362417|NCT01971853|BG001|Baseline|Oral Analgesics|"5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen~Oral Analgesics: Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen"
11362418|NCT01971853|BG002|Baseline|Total|Total of all reporting groups
11362419|NCT01971853|FG000|Participant Flow|Oral Placebo|"an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen~oral placebo: Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen"
11362420|NCT01971853|FG001|Participant Flow|Oral Analgesics|"5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen~Oral Analgesics: Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen"
11362421|NCT01971853|OG000|Outcome|Oral Placebo|"an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen~oral placebo: Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen"
11362422|NCT01971853|OG001|Outcome|Oral Analgesics|"5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen~Oral Analgesics: Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen"
11362423|NCT01971853|EG000|Reported Event|Oral Placebo|"an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen~oral placebo: Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen"
11362424|NCT01971853|EG001|Reported Event|Oral Analgesics|"5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen~Oral Analgesics: Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen"
11362425|NCT01980875|BG000|Baseline|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362426|NCT01980875|BG001|Baseline|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362427|NCT01980875|BG002|Baseline|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362428|NCT01980875|BG003|Baseline|Total|Total of all reporting groups
11362429|NCT01980875|FG000|Participant Flow|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib (Zydelig®) 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362430|NCT01980875|FG001|Participant Flow|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362431|NCT01980875|FG002|Participant Flow|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362432|NCT01980875|OG000|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362433|NCT01980875|OG001|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362434|NCT01980875|OG002|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362435|NCT01980875|EG000|Reported Event|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362436|NCT01980875|EG001|Reported Event|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362437|NCT01980875|EG002|Reported Event|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
11362438|NCT01982383|BG000|Baseline|Micropulse Laser Treatment|"Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine~Micropulse Laser Treatment"
11362439|NCT01982383|BG001|Baseline|No Treatment|"Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending~No treatment"
11362440|NCT01982383|BG002|Baseline|Total|Total of all reporting groups
11362441|NCT01982383|FG000|Participant Flow|Micropulse Laser Treatment|"Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine~Micropulse Laser Treatment"
11362442|NCT01982383|FG001|Participant Flow|No Treatment|"Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending~No treatment"
11362443|NCT01982383|OG000|Outcome|Micropulse Laser Treatment|"Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine~Micropulse Laser Treatment"
11362444|NCT01982383|OG001|Outcome|No Treatment|"Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending~No treatment"
11362445|NCT01982383|EG000|Reported Event|Micropulse Laser Treatment|"Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine~Micropulse Laser Treatment"
11362446|NCT01982383|EG001|Reported Event|No Treatment|"Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending~No treatment"
11362447|NCT01980342|BG000|Baseline|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
11362448|NCT01980342|FG000|Participant Flow|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
11362449|NCT01980342|OG000|Outcome|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
11362450|NCT01980342|EG000|Reported Event|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
11362451|NCT01978535|BG000|Baseline|Iron Infusion|Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
11362452|NCT01978535|BG001|Baseline|Normal Saline Infusion|Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
11362453|NCT01978535|BG002|Baseline|Total|Total of all reporting groups
11362454|NCT01978535|FG000|Participant Flow|Iron Infusion|Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
11362455|NCT01978535|FG001|Participant Flow|Normal Saline Infusion|Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
11188633|NCT02115113|EG000|Reported Event|Run-in Population Total|At study start, participants received an Everolimus starting dose of 1.0 mg twice daily in combination with Tacrolimus. Tacrolimus was administered as per center practice. Thereafter, Everolimus doses were adjusted to achieve Everolimus C-0h blood trough levels between 3-8 ng/mL by week 1 after drug initiation until 5 months after transplant
11188634|NCT02115113|EG001|Reported Event|Run-in Population Tacrolimus Elimination|At study start, participants received an Everolimus starting dose of 1.0 mg twice daily in combination with Tacrolimus. Tacrolimus was administered as per center practice. Thereafter, Everolimus doses were adjusted to achieve Everolimus C-0h blood trough levels between 3-8 ng/mL by week 1 after drug initiation until 5 months after transplant
11188635|NCT02115113|EG002|Reported Event|Run-in Population Tacrolimus Minimization|At study start, participants received an Everolimus starting dose of 1.0 mg twice daily in combination with Tacrolimus. Tacrolimus was administered as per center practice. Thereafter, Everolimus doses were adjusted to achieve Everolimus C-0h blood trough levels between 3-8 ng/mL by week 1 after drug initiation until 5 months after transplant
11188636|NCT02115113|EG003|Reported Event|Randomization Treatment Period Tacrolimus Elimination|At 5 months after transplant at randomization, Everolimus doses were adjusted to achieve C-0h blood trough level target ranges 6-10 ng/mL. Tacrolimus withdrawal was completed by 6 months after transplant.
11188637|NCT02115113|EG004|Reported Event|Randomization Treatment Period Tacrolimus Minimization|At 5 months after transplant at randomization, Everolimus doses continued to be adjusted to achieve C-0h blood trough level target ranges 3-8 ng/mL and Tacorlimus doses were adjusted to achieve C-0h blood trough level target ranges 3-5 ng/mL.
11188638|NCT02115139|BG000|Baseline|Ipilimumab|"Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles Whole-brain radiotherapy (WBRT) 30 Gy in 10 fractions (or radiobiological equivalent schedule, after Sponsor approval), starting between Cycle 1 Day 2 and Cycle 2 Day 1~Ipilimumab: Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles"
11188639|NCT02115139|FG000|Participant Flow|Ipilimumab|"Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles Whole-brain radiotherapy (WBRT) 30 Gy in 10 fractions (or radiobiological equivalent schedule, after Sponsor approval), starting between Cycle 1 Day 2 and Cycle 2 Day 1~Ipilimumab: Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles"
11188640|NCT02115139|OG000|Outcome|Ipilimumab|"Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles Whole-brain radiotherapy (WBRT) 30 Gy in 10 fractions (or radiobiological equivalent schedule, after Sponsor approval), starting between Cycle 1 Day 2 and Cycle 2 Day 1~Ipilimumab: Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles"
11188641|NCT02115139|EG000|Reported Event|Ipilimumab|"Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles Whole-brain radiotherapy (WBRT) 30 Gy in 10 fractions (or radiobiological equivalent schedule, after Sponsor approval), starting between Cycle 1 Day 2 and Cycle 2 Day 1~Ipilimumab: Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles"
11188642|NCT02115256|BG000|Baseline|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
11188643|NCT02115256|BG001|Baseline|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
11188644|NCT02115256|BG002|Baseline|Total|Total of all reporting groups
11188645|NCT02115256|FG000|Participant Flow|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
11188646|NCT02115256|FG001|Participant Flow|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
11188647|NCT02115256|OG000|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
11188648|NCT02115256|OG001|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
11188649|NCT02115256|EG000|Reported Event|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
11188650|NCT02115256|EG001|Reported Event|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
11188651|NCT02115269|BG000|Baseline|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
11188652|NCT02115269|FG000|Participant Flow|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
11188653|NCT02115269|OG000|Outcome|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
11239837|NCT02473783|EG000|Reported Event|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
11239838|NCT02473783|EG001|Reported Event|Healthy Control Group|All healthy subjects had only basal I-123-ADAM SPECT scanning.
11239839|NCT02473913|BG000|Baseline|Milk Thistle, Then Placebo|Participants first received Milk Thistle for 6 weeks. After a washout period of 1 week, they then received matching placebo for 6 weeks.
11239840|NCT02473913|BG001|Baseline|Placebo, Then Milk Thistle|Participants first received matching placebo for 6 weeks. After a washout period of 1 week, they then received Milk Thistle for 6 weeks.
11239841|NCT02473913|BG002|Baseline|Total|Total of all reporting groups
11239842|NCT02473913|FG000|Participant Flow|Experimental: Milk Thistle, Then Placebo|Participants first received Milk Thistle for 6 weeks. After a washout period of 1 week, they then received matching Placebo for 6 weeks.
11239843|NCT02473913|FG001|Participant Flow|Experimetal: Placebo, Then Milk Thistle|Participants first received matching Placebo for 6 weeks. After a washout period of 1 week, they then received matching Milk Thistle for 6 weeks.
11239844|NCT02473913|OG000|Outcome|Milk Thistle|"Each subject will have a 6 week treatment phase with milk thistle.~Milk Thistle"
11239845|NCT02473913|OG001|Outcome|Placebo|"6 week placebo phase before or after milk thistle phase depending on randomization.~Placebo"
11239846|NCT02473913|EG000|Reported Event|Milk Thistle|"Each subject will have a 6 week treatment phase with milk thistle.~Milk Thistle"
11239847|NCT02473913|EG001|Reported Event|Placebo|"6 week placebo phase before or after milk thistle phase depending on randomization.~Placebo"
11239848|NCT02473952|BG000|Baseline|IGIV-C|"IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.~An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).~IGIV-C: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified"
11239849|NCT02473952|BG001|Baseline|Placebo|"Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).~Placebo"
11239850|NCT02473952|BG002|Baseline|Total|Total of all reporting groups
11239851|NCT02473952|FG000|Participant Flow|IGIV-C|"IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.~An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).~IGIV-C: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified"
11239852|NCT02473952|FG001|Participant Flow|Placebo|"Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).~Placebo"
10962660|NCT00867789|FG001|Participant Flow|Sugar Pill|"Incision and drainage of the abscess and treatment with oral placebo (100 patients)~Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder."
11239853|NCT02473952|OG000|Outcome|IGIV-C|"IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.~An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).~IGIV-C: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified"
11239854|NCT02473952|OG001|Outcome|Placebo|"Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).~Placebo"
11239855|NCT02473952|EG000|Reported Event|IGIV-C|"IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.~An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).~IGIV-C: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified"
11239856|NCT02473952|EG001|Reported Event|Placebo|"Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).~Placebo"
11239857|NCT02473965|BG000|Baseline|IGIV-C|"IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive IGIV-C were given a loading dose of 2 g/kg by IV infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase.~CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13).~Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments."
10962661|NCT00867789|OG000|Outcome|Trimethoprim-sulfamethaxazole|"Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)~Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)"
11188654|NCT02115269|OG000|Outcome|Significant Pain Reduction at 1 Hour Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 1 hour post dose
11188655|NCT02115269|OG001|Outcome|Significant Pain Reduction at 2 Hours Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose
11188656|NCT02115269|OG002|Outcome|Significant Pain Reduction at 4 Hour Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose
11188657|NCT02115269|OG003|Outcome|Significant Pain Reduction at 6 Hours Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose
11188658|NCT02115269|OG004|Outcome|Significant Pain Reduction at 24 Hours Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose
11188659|NCT02115269|OG000|Outcome|Patients With Primary Headaches and Took Triptans in the Past|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice who took triptans in the past.
11188660|NCT02115269|OG001|Outcome|Patients With Primary Headaches Who Took NSAIDs and Analgesics|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took NSAIDs and analgesics
11188661|NCT02115269|OG002|Outcome|Patients Who Took Combined Analgesics|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took combined analgesics in the past
11188662|NCT02115269|OG003|Outcome|Patients Who Took Ergotamine-based Drugs|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took ergotamine-based drugs in the past
11188663|NCT02115269|OG004|Outcome|Patients Who Took Antiemetics|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took antiemetics in the past
11188664|NCT02115269|OG005|Outcome|Patients Who Took Opioid Analgesics|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past
11188665|NCT02115269|EG000|Reported Event|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
11188666|NCT02115282|BG000|Baseline|Arm A (Exemestane, Entinostat)|"Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Entinostat: Given PO~Exemestane: Given PO~Goserelin Acetate: Given SC"
11188667|NCT02115282|BG001|Baseline|Arm B (Exemestane, Placebo)|"Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Exemestane: Given PO~Goserelin Acetate: Given SC~Placebo Administration: Given PO"
11188668|NCT02115282|BG002|Baseline|Total|Total of all reporting groups
11188669|NCT02115282|FG000|Participant Flow|Arm A (Exemestane, Entinostat)|"Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Entinostat: Given PO~Exemestane: Given PO~Goserelin Acetate: Given SC"
11188670|NCT02115282|FG001|Participant Flow|Arm B (Exemestane, Placebo)|"Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Exemestane: Given PO~Goserelin Acetate: Given SC~Placebo Administration: Given PO"
11188671|NCT02115282|OG000|Outcome|Arm A (Exemestane, Entinostat)|"Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Entinostat: Given PO~Exemestane: Given PO~Goserelin Acetate: Given SC"
11188672|NCT02115282|OG001|Outcome|Arm B (Exemestane, Placebo)|"Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Exemestane: Given PO~Goserelin Acetate: Given SC~Placebo Administration: Given PO"
11188673|NCT02115282|OG000|Outcome|Arm A (Exemestane, Entinostat)- Lysine Acetylation Change>=1.5 Fold|"Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Entinostat: Given PO~Exemestane: Given PO~Goserelin Acetate: Given SC"
11362456|NCT01978535|OG000|Outcome|Iron Infusion|Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
11362457|NCT01978535|OG001|Outcome|Normal Saline Infusion|Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
11188674|NCT02115282|OG001|Outcome|Arm A (Exemestane, Entinostat)- Lysine Acetylation Change<1.5 Fold|"Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Entinostat: Given PO~Exemestane: Given PO~Goserelin Acetate: Given SC"
11188675|NCT02115282|EG000|Reported Event|Arm A (Exemestance, Entinostat)|"Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Entinostat: Given PO~Exemestane: Given PO~Goserelin Acetate: Given SC"
11188676|NCT02115282|EG001|Reported Event|Arm A (Exemestance, Placebo)|"Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Exemestane: Given PO~Goserelin Acetate: Given SC~Placebo Administration: Given PO"
11188677|NCT02115308|BG000|Baseline|CONTROL|"Myocardial strain imaging was performed for all subjects in a similar order. Rest-tag imaging was performed first, then Stress-tag imaging was performed at maximal heart rate following administration of the regadenoson dose.~Strain values were then calculated for each of 16-segments for each subject. Segments are classified based on myocardial perfusion imaging scores.~A control subject is an individual from a low-likelihood CAD population with a prior clinically indicated PET with perfusion and wall motion scores (rest-to-stress)."
11188678|NCT02115308|BG001|Baseline|Coronary Artery Disease|"Myocardial strain imaging was performed for all subjects in a similar order. Rest-tag imaging was performed first, then Stress-tag imaging was performed at maximal heart rate following administration of the regadenoson dose.~Strain values were then calculated for each of 16-segments for each subject. Segments are classified based on myocardial perfusion imaging scores.~A Coronary artery disease subject is an individual from a CAD population with a prior clinically indicated PET with perfusion and wall motion scores (rest-to-stress)."
11188679|NCT02115308|BG002|Baseline|Total|Total of all reporting groups
11188680|NCT02115308|FG000|Participant Flow|CONTROL|"Myocardial strain imaging was performed for all subjects in a similar order. Rest-tag imaging was performed first, then Stress-tag imaging was performed at maximal heart rate following administration of the regadenoson dose.~Strain values were then calculated for each of 16-segments for each subject. Segments are classified based on myocardial perfusion imaging scores.~A Control subject is an individual from a population of low-likelihood CAD exhibiting both normal perfusion score and normal wall motion score rest-to-stress as indicated on a clinically indicated PET."
11188681|NCT02115308|FG001|Participant Flow|Coronary Artery Disease|"Myocardial strain imaging was performed for all subjects in a similar order. Rest-tag imaging was performed first, then Stress-tag imaging was performed at maximal heart rate following administration of the regadenoson dose.~Strain values were then calculated for each of 16-segments for each subject. Segments are classified based on myocardial perfusion imaging scores.~A Coronary Artery Disease (CAD) subject is an individual from a population with CAD exhibiting both normal perfusion and normal wall motion scores (rest-to-stress) on a prior clinically indicated PET."
11188682|NCT02115308|OG000|Outcome|CONTROL|A myocardial segment from an individual from a low-likelihood coronary-artery-disease (CAD) population exhibiting both normal perfusion and normal wall motion scores (rest-to-stress) on a prior clinically indicated PET.
11188683|NCT02115308|OG001|Outcome|CAD_REMOTE|A myocardial segment from an individual from a population with CAD exhibiting normal perfusion scores and normal wall motion scores (rest-to-stress) on a prior clinically indicated PET.
11188684|NCT02115308|OG002|Outcome|CAD_REVERSIBLE|A myocardial segment from an individual from a population with CAD exhibiting a change in perfusion scores and a change in wall motion scores (rest-to-stress) on a prior clinically indicated PET.
11188685|NCT02115308|OG000|Outcome|CONTROL|A myocardial segment from an individual from a low-likelihood CAD population exhibiting both normal perfusion and normal wall motion scores (rest-to-stress) on a prior clinically indicated PET.
11188686|NCT02115308|OG001|Outcome|LGE-|A myocardial segment from an individual from a population with CAD exhibiting normal perfusion scores and normal wall motion scores (rest-to-stress) on a prior clinically indicated PET.
11188687|NCT02115308|OG002|Outcome|LGE+|A myocardial segment from an individual from a population with CAD exhibiting a change in perfusion scores and a change in wall motion scores (rest-to-stress) on a prior clinically indicated PET.
11188688|NCT02115308|OG000|Outcome|Regadenoson|"Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.~Regadenoson: Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.~All subjects received a dose of Regadenoson to perform stress imaging of myocardial strain within a single cardiac magnetic resonance (CMR) imaging session."
11188689|NCT02115308|EG000|Reported Event|Regadenoson|"Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.~Regadenoson: Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.~Strain imaging was performed on ALL subjects in the same order with resting strain preceding regadenoson stress strain. Myocardial segments were classified based on prior clinical positron-emission-tomography (PET) results so that segmental strain response to regadenoson could be observed."
11188690|NCT02115321|BG000|Baseline|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
11188691|NCT02115321|BG001|Baseline|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
11188692|NCT02115321|BG002|Baseline|Total|Total of all reporting groups
11188693|NCT02115321|FG000|Participant Flow|Part A: CP-B GZR 50 mg + EBR 50 mg|Child-Pugh score 7 to 9 (CP-B) participants take GZR 50 mg + EBR 50 mg once daily (q.d.) by mouth for 12 weeks.
11188694|NCT02115321|FG001|Participant Flow|Part A: NC GZR 100 mg + EBR 50 mg|Non-cirrhotic (NC) participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
11188695|NCT02115321|OG000|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
11188696|NCT02115321|OG001|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
11362458|NCT01978535|EG000|Reported Event|Iron Infusion|Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
11362459|NCT01978535|EG001|Reported Event|Normal Saline Infusion|Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
11362460|NCT01974635|BG000|Baseline|AMES Therapy|The AMES device rotates the hand into flexion and extension, while the participant assists with this motion and receives visual feedback of the motion. At the same time, the AMES device vibrates the muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so. This study provides for 25 AMES training sessions over 8-13 weeks. At the end of the intervention, the participant's proprioception (i.e., sense of joint position and movement) is tested by asking the participant, with eyes closed, to blink as the fingers and thumb or the wrist are rotated through a prescribed joint angle (i.e., target angle) by the AMES device.
11362461|NCT01974635|FG000|Participant Flow|AMES Therapy|The AMES device rotates the hand into flexion and extension, while the participant assists with this motion and receives visual feedback of the motion. At the same time, the AMES device vibrates the muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so. This study provides for 25 AMES training sessions over 8-13 weeks.
11362462|NCT01974635|OG000|Outcome|AMES Therapy and Diagnostic|"AMES therapy: During treatment, the AMES device rotates the hand, into flexion and extension, while the patient assists with this motion,and while the lengthening muscle(s) are vibrated mechanically. At the end of the treatment, several diagnostic tests are performed to measure the participant's level of proprioceptive perception. This study provides for 25 AMES treatments and diagnostic tests over 8-13 weeks, at a rate of 2-3 sessions per week.~AMES Diagnostic: Immediately following the therapy session, the AMES device rotates the hand into flexion and extension, while the patient, with eyes closed, indicates verbally the perceived direction of motion."
11362463|NCT01974635|OG000|Outcome|AMES Therapy and Diagnostic|"AMES therapy: During treatment, the AMES device rotates the hand, into flexion and extension, while the patient assists with this motion,and while the lengthening muscle(s) are vibrated mechanically. At the end of the treatment, several diagnostic tests are performed to measure the participant's level of proprioceptive perception. This study provides for 25 AMES treatments and diagnostic tests over 8-13 weeks, at a rate of 2-3 sessions per week.~AMES Diagnostic: Immediately following the therapy session, the AMES device rotates the hand into flexion or extension, while the patient, with eyes closed, indicates the moment he/she perceives the hand passes through a prescribed joint angle."
11362464|NCT01974635|EG000|Reported Event|AMES Therapy and Diagnostic|"AMES therapy: During treatment, the AMES device rotates the hand, into flexion and extension, while the patient assists with this motion,and while the lengthening muscle(s) are vibrated mechanically. At the end of the treatment, several diagnostic tests are performed to measure the participant's level of proprioceptive perception. This study provides for 25 AMES treatments and diagnostic tests over 8-13 weeks, at a rate of 2-3 sessions per week.~AMES Diagnostic: Either at baseline and 10-13 weeks later, or immediately following each therapy session, the participant performs a number of diagnostic tests to determine his/her level of proprioceptive perception."
11362465|NCT01975467|BG000|Baseline|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
11362466|NCT01975467|BG001|Baseline|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
11362467|NCT01975467|BG002|Baseline|Total|Total of all reporting groups
11362468|NCT01975467|FG000|Participant Flow|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
11362469|NCT01975467|FG001|Participant Flow|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
11362470|NCT01975467|OG000|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
11362471|NCT01975467|OG001|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
11362472|NCT01975467|EG000|Reported Event|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
11362473|NCT01975467|EG001|Reported Event|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
11362474|NCT01970462|BG000|Baseline|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
11362475|NCT01970462|BG001|Baseline|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
11362476|NCT01970462|BG002|Baseline|Total|Total of all reporting groups
11362477|NCT01970462|FG000|Participant Flow|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
11362478|NCT01970462|FG001|Participant Flow|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
11362479|NCT01970462|OG000|Outcome|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
11362480|NCT01970462|OG001|Outcome|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
11362481|NCT01970462|EG000|Reported Event|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
11362482|NCT01970462|EG001|Reported Event|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
11362483|NCT01969565|BG000|Baseline|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
11362484|NCT01969565|FG000|Participant Flow|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
11362485|NCT01969565|OG000|Outcome|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
11362486|NCT01969565|OG000|Outcome|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
11362487|NCT01969565|EG000|Reported Event|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
11362488|NCT01968226|BG000|Baseline|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.~[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
11362489|NCT01968226|FG000|Participant Flow|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.~[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
11362490|NCT01968226|OG000|Outcome|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.~[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
10962662|NCT00867789|OG001|Outcome|Sugar Pill|"Incision and drainage of the abscess and treatment with oral placebo (100 patients)~Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder."
11362491|NCT01968226|EG000|Reported Event|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.~[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
11362492|NCT01965782|BG000|Baseline|[^14C]-LY3023703|Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
11362493|NCT01965782|FG000|Participant Flow|[^14C]-LY3023703|Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
11362494|NCT01965782|OG000|Outcome|[^14C]-LY3023703|Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
11362495|NCT01965782|EG000|Reported Event|[^14C]-LY3023703|Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
11362496|NCT01962675|BG000|Baseline|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
11362497|NCT01962675|BG001|Baseline|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
11362498|NCT01962675|BG002|Baseline|Total|Total of all reporting groups
11362499|NCT01962675|FG000|Participant Flow|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
11362500|NCT01962675|FG001|Participant Flow|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
11362501|NCT01962675|OG000|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
11362502|NCT01962675|OG001|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
11362503|NCT01962675|OG000|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
11362504|NCT01962675|OG001|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
11188697|NCT02115321|EG000|Reported Event|CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
11362505|NCT01962675|EG000|Reported Event|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
11362506|NCT01962675|EG001|Reported Event|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
11362507|NCT01962974|BG000|Baseline|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
11362508|NCT01962974|FG000|Participant Flow|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
11362509|NCT01962974|OG000|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
11362510|NCT01962974|EG000|Reported Event|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
11362511|NCT01954160|BG000|Baseline|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
11362512|NCT01954160|BG001|Baseline|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
11362513|NCT01954160|BG002|Baseline|Total|Total of all reporting groups
11362514|NCT01954160|FG000|Participant Flow|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
11362515|NCT01954160|FG001|Participant Flow|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
11362516|NCT01954160|OG000|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
11188698|NCT02115321|EG001|Reported Event|Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
11188699|NCT02115347|BG000|Baseline|Ertugliflozin 15 mg (Moderate Hepatic Impairment)|Participants received a single 15 mg oral dose (tablet) of ertugliflozin.
11188700|NCT02115347|BG001|Baseline|Ertugliflozin 15 mg (Normal Hepatic Function)|Participants received a single 15 mg oral dose (tablet) of ertugliflozin.
11188701|NCT02115347|BG002|Baseline|Total|Total of all reporting groups
11188702|NCT02115347|FG000|Participant Flow|Ertugliflozin 15 mg (Moderate Hepatic Impairment)|Participants received a single 15 mg oral dose (tablet) of ertugliflozin.
11188703|NCT02115347|FG001|Participant Flow|Ertugliflozin 15 mg (Normal Hepatic Function)|Participants received a single 15 mg oral dose (tablet) of ertugliflozin.
11188704|NCT02115347|FG002|Participant Flow|Ertugliflozin 15 mg - Mild Hepatic Impairment|Participants receive a single 15 mg oral dose (tablet) of ertugliflozin
11188705|NCT02115347|OG000|Outcome|Ertugliflozin 15 mg (Moderate Hepatic Impairment)|Participants received a single 15 mg oral dose (tablet) of ertugliflozin.
11188706|NCT02115347|OG001|Outcome|Ertugliflozin 15 mg (Normal Hepatic Function)|Participants received a single 15 mg oral dose (tablet) of ertugliflozin.
11188707|NCT02115347|EG000|Reported Event|Ertugliflozin 15 mg (Moderate Hepatic Impairment)|Participants received a single 15 mg oral dose (tablet) of ertugliflozin.
11188708|NCT02115347|EG001|Reported Event|Ertugliflozin 15 mg (Normal Hepatic Function)|Participants received a single 15 mg oral dose (tablet) of ertugliflozin.
11188709|NCT02115373|BG000|Baseline|Phase 1b: Tepotinib 300 mg|Participants received a single oral dose of Tepotinib 300mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188710|NCT02115373|BG001|Baseline|Phase 1b: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188711|NCT02115373|BG002|Baseline|Phase 2: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188712|NCT02115373|BG003|Baseline|Total|Total of all reporting groups
11188713|NCT02115373|FG000|Participant Flow|Phase 1b: Tepotinib 300 mg|Participants received a single oral dose of Tepotinib 300 milligram (mg) daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188714|NCT02115373|FG001|Participant Flow|Phase 1b: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188715|NCT02115373|FG002|Participant Flow|Phase 2: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188716|NCT02115373|OG000|Outcome|Phase 1b: Tepotinib 300 mg|Participants received a single oral dose of Tepotinib 300mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188717|NCT02115373|OG001|Outcome|Phase 1b: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188718|NCT02115373|OG000|Outcome|Phase 2: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 day treatment cycle until confirmed disease progression.
11188719|NCT02115373|OG000|Outcome|Phase 1b: Tepotinib 300 mg|Participants received a single oral dose of Tepotinib 300 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188720|NCT02115373|OG001|Outcome|Phase 1b: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188721|NCT02115373|OG002|Outcome|Phase 2: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188722|NCT02115373|OG000|Outcome|Phase 2: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188723|NCT02115373|OG000|Outcome|Phase 1b: Tepotinib 300 mg|Participants received a single oral dose of Tepotinib 300 mg daily in each 21 day treatment cycle until confirmed disease progression.
11188724|NCT02115373|OG001|Outcome|Phase 1b: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 day treatment cycle until confirmed disease progression.
11188725|NCT02115373|OG002|Outcome|Phase 2: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 day treatment cycle until confirmed disease progression.
11188726|NCT02115373|EG000|Reported Event|Phase 1b: Tepotinib 300 mg|Participants received a single oral dose of Tepotinib 300 milligram (mg) daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188727|NCT02115373|EG001|Reported Event|Phase 1b: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188728|NCT02115373|EG002|Reported Event|Phase 2: Tepotinib 500 mg|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
11188729|NCT02115386|BG000|Baseline|Nilotinib|Dosage was 300 mg BID daily taken orally without food.
11188730|NCT02115386|FG000|Participant Flow|Nilotinib|Dosage was 300 mg BID daily taken orally without food.
11188731|NCT02115386|OG000|Outcome|Nilotinib|Dosage was 300 mg BID daily taken orally without food.
11188732|NCT02115386|EG000|Reported Event|Nilotinib|Nilotinib
11362517|NCT01954160|OG001|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
11188733|NCT02115542|BG000|Baseline|Regorafenib Monotherapy|"Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.~Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast."
11188734|NCT02115542|FG000|Participant Flow|Regorafenib Monotherapy|"Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.~Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast."
11188735|NCT02115542|OG000|Outcome|Regorafenib Monotherapy|"Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.~Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast."
11188736|NCT02115542|EG000|Reported Event|Regorafenib Monotherapy|"Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.~Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast."
11188737|NCT02115581|BG000|Baseline|Conezyme Q10|known cases of idiopathic dilated cardiomyopathy who received Co Q10
11188738|NCT02115581|BG001|Baseline|Placebo|known cases of idiopathic dilated cardiomyopathy who received the placebo
11188739|NCT02115581|BG002|Baseline|Total|Total of all reporting groups
11188740|NCT02115581|FG000|Participant Flow|Coenzyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
11188741|NCT02115581|FG001|Participant Flow|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
11188742|NCT02115581|OG000|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
11188743|NCT02115581|OG001|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
11188744|NCT02115581|EG000|Reported Event|Coenzyme Q10 (Study Group)|"Known cases of idiopathic dilated cardiomyopathy~Coenzyme Q10: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance"
11188745|NCT02115581|EG001|Reported Event|Placebo (Control Group)|"Known cases of idiopathic dilated cardiomyopathy~Placebo: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance"
11188746|NCT02115607|BG000|Baseline|Definity Infusion|"Infusion of Definity (Perflutren Lipid Microspheres)~Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min"
11188747|NCT02115607|FG000|Participant Flow|Definity Infusion|"Infusion of Definity (Perflutren Lipid Microspheres)~Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min"
11188748|NCT02115607|OG000|Outcome|Definity Infusion|"Infusion of Definity (Perflutren Lipid Microspheres)~Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min"
11188749|NCT02115607|EG000|Reported Event|Definity Infusion|"Infusion of Definity (Perflutren Lipid Microspheres)~Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min"
11188750|NCT02115633|BG000|Baseline|Walkasins On|"Group A subjects first wore Walkasins and received real-time vibrotactile feedback that reflects real changes in center of pressure sway. Following a 1-hour rest period, they were retested with Walkasins turned off.~The results for the Walkasins On state include all subjects, combining Group A, who were randomized to initially be tested with Walkasins turned on and then retested with walkasins turned off, and Group B, who were randomized to initially be tested with Walkasins turned off and then retested with Walkasins turned on."
11188751|NCT02115633|BG001|Baseline|Walkasins Off|"Group B subjects first wore Walkasins turned off and not receive any vibrotactile feedback. Following a 1-hour rest period, they were retested with Walkasins turned on.~The results for the Walkasins Off state include all subjects, combining Group A, who were randomized to initially be tested with Walkasins turned on and then retested with walkasins turned off, and Group B, who were randomized to initially be tested with Walkasins turned off and then retested with Walkasins turned on."
11188752|NCT02115633|BG002|Baseline|Total|Total of all reporting groups
11188753|NCT02115633|FG000|Participant Flow|Walkasins On Then Off|"Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a 1-hour rest period they will be retested with Walkasins turned off.~Walkasins On: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.~Walkasins Off: Subjects will be wearing a device that is turned off."
11188754|NCT02115633|FG001|Participant Flow|Walkasins Off Then On|"Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a 1-hour rest period they will be retested with Walkasins turned on.~Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.~Walkasins OFF: Subjects will be wearing a device that is turned off."
11188755|NCT02115633|OG000|Outcome|Walkasins ON|Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.
11188756|NCT02115633|OG001|Outcome|Walkasins OFF|Walkasins OFF: Subjects will wear Walkasins turned off and not receive any vibrotactile feedback.
11188757|NCT02115633|OG001|Outcome|Walkasins OFF|Walkasins OFF: Subjects will be wearing a device that is turned off.
11188758|NCT02115633|OG000|Outcome|Walkasins ON Then OFF|"Subjects will wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a 1-hour rest period they will be retested with Walkasins turned off.~Walkasins On: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway."
11188759|NCT02115633|OG001|Outcome|Walkasins OFF|"Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a 1-hour rest period they will be retested with Walkasins turned on.~Walkasins Off: Subjects will be wearing a device that is turned off."
11362518|NCT01954160|OG000|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
11362519|NCT01954160|OG001|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
11362520|NCT01954160|EG000|Reported Event|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
11362521|NCT01954160|EG001|Reported Event|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
11362522|NCT01951378|BG000|Baseline|Hudson RCI® Nebulizer|"Patients randomized to standard arm receives treatments per standard ED asthma pathway. Treatments administered with standard ED nebulizer, Hudson RCI® Up-Draft® Neb-U-Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ), and a simple mask (Hudson RCI®, Teleflex Medical®, Research Triangle Park, NJ).~Hudson RCI® nebulizer: After 1 hour, patients in standard arm receive another assessment, with all baseline measurements and reported side effects. Patients who score PAS 0-2 will be discharged, after optional observation period, per pathway. Those who score PAS > 2 receive second treatment, then re-assessed, and measurements repeated. Then, depending on PAS score, he/she will be sent, the floor, the pulmonary high acuity unit (PHAU), or PICU.~Albuterol: Subjects may begin treatment before consent and may receive 2.5 mg Albuterol/Proventil treatments given with standard nebulizer <3 times as needed and may change over to study randomized device once consented to either arm."
11362523|NCT01951378|BG001|Baseline|NebuTech® HDN® Nebulizer|"Randomized patients receive treatments per rapid Albuterol/Proventil delivery pathway. Nebulizations given via Breath-Enhanced High Density Jet Nebulizer, NebuTech® HighDensityNebulizer®,(Salter Labs®, Arvin, CA). If child will not or cannot use mouthpiece, a mask will be used.~NebuTech® HDN® nebulizer: Treatments are dilution of 5 ml. Patients receive <4 treatments with measurements after each. Patients who complete 4 treatments will be dispositioned based on PAS score. Subjects may begin treatment before consent and may receive 2.5 mg Albuterol/Proventil treatments via standard nebulizer <3 times as needed and may change to study randomized device once consented to either arm.~Albuterol: Subjects may start treatment before consent and may receives 2.5 mg Albuterol/Proventil given with standard nebulizer <3 times as needed and may change over to study randomized device once consented to either arm."
11362524|NCT01951378|BG002|Baseline|Total|Total of all reporting groups
11362525|NCT01951378|FG000|Participant Flow|Hudson RCI® Nebulizer|"Patients randomized to the standard arm will receive treatments as dictated by our standard ED asthma pathway (Fig. 1). All treatments will be administered with our standard ED nebulizer, the Hudson RCI® Up-Draft® Neb-U-Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ), and a simple mask (Hudson RCI®, Teleflex Medical®, Research Triangle Park, NJ).~Hudson RCI® nebulizer: After the first hour of treatment, patients in the standard arm will receive a repeat assessment, including all of the measurements collected at baseline as well as reported side effects. Those patients who score PAS 0-2 will then be discharged home, after an optional observation period, as per the pathway. Those who score PAS > 2 will receive a second treatment. At the end of the second treatment patients will again be re-assessed, and repeat measurements obtained. At that time, depending on the patient's PAS score, he/she will be dispositioned to home, the floor, the pulmonary high acuity unit (PHA"
11362526|NCT01951378|FG001|Participant Flow|NebuTech® HDN® Nebulizer|"Patients randomized to the NebuTech® arm will receive treatments as dictated by our trial pathway, referred to as the rapid Albuterol/Proventil delivery pathway (Fig. 2). All nebulizations in this arm will be administered via the Breath-Enhanced High Density Jet Nebulizer, NebuTech® HighDensityNebulizer®,(Salter Labs®, Arvin, CA). Respiratory Therapists (RT) will attempt to deliver all treatments with a mouthpiece, as that has been shown to be the most efficient and reliable mode of aerosol delivery for most children 31, 32. If the Respiratory Therapist feels that the child will not or cannot effectively use a mouthpiece, a mask will be used.~NebuTech® HDN® nebulizer: All treatments in the NebuTech® arm will be given at a standard dilution of 5 ml (diluted with normal saline to a total volume of 5 ml as per the manufacturer's recommendation). Patients in this arm will receive up to four treatments with parameters measured after each treatment, similar to the control arm. Patient"
11362527|NCT01951378|OG000|Outcome|Hudson RCI® Nebulizer|"Patients randomized to standard arm receives treatments by standard ED asthma pathway. Treatments administered with standard ED nebulizer, Hudson RCI® Up-Draft® Neb-U-Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ), and simple mask (Hudson RCI®, Teleflex Medical®, Research Triangle Park, NJ). Hudson RCI® nebulizer: After 1 hour, patients in standard arm have repeat assessment, with all measurements collected at baseline and reported side effects. Patients who score PAS 0-2 will be discharged after observation, per pathway. Those who score PAS > 2 receive second treatment. After second treatment patients re-assessed, and repeat measurements obtained. Then, based on score, he/she will be dispositioned home, the floor, pulmonary high acuity unit (PHAU), or (PICU).~Albuterol: Subjects may have treatment before consent and may receive 2.5 mg treatments with standard nebulizer up to 3 times as needed and may change to randomized device once consented to either arm."
11362528|NCT01951378|OG001|Outcome|NebuTech® HDN® Nebulizer|"Patients randomized to NebuTech® arm receive treatments by, rapid Albuterol/Proventil delivery pathway, given by Breath-Enhanced High Density Jet Nebulizer, NebuTech® HighDensityNebulizer®,(Salter Labs®, Arvin, CA). Respiratory Therapists (RT) will try to give treatments with mouthpiece, shown most efficient and reliable mode of aerosol delivery for children. If RT feels child will not or cannot use a mouthpiece, a mask will be used.~NebuTech® HDN® nebulizer: Treatments given at 5 ml (diluted with normal saline). Patients complete <4 treatments, dispositioned based on PAS. Subjects may start treatment before consent and may receive 2.5 mg Albuterol/Proventil treatments given with standard nebulizer <3 times as needed and may change to study randomized device once consented.~Albuterol: Subjects start treatment before consent and may receive 2.5 mg. Treatments receive standard nebulizer up to 3 times as needed and may change to randomized device once consented to either arm."
11239858|NCT02473965|BG001|Baseline|Placebo|"IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase.~CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13).~Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments."
11239859|NCT02473965|BG002|Baseline|Total Title|
11239860|NCT02473965|FG000|Participant Flow|IGIV-C|"Investigational Product (IP) Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) were given a loading dose of 2 grams per kilogram (g/kg) by intravenous (IV) infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase.~CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13).~Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments."
11239861|NCT02473965|FG001|Participant Flow|Placebo|"IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase.~CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13).~Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments."
11239862|NCT02473965|OG000|Outcome|IGIV-C|"IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive IGIV-C were given a loading dose of 2 g/kg by IV infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase.~CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13).~Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments."
11239863|NCT02473965|OG001|Outcome|Placebo|"IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase.~CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13).~Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments."
11239864|NCT02473965|EG000|Reported Event|IGIV-C|"IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive IGIV-C were given a loading dose of 2 g/kg by IV infusion at Baseline/Week 0 (Visit 1) and 2 maintenance doses of 1 g/kg at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase.~CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses (1 g/kg) every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of IGIV-C was given. The last CS dose reduction was at Week 36 (Visit 13).~Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments."
11239865|NCT02473965|EG001|Reported Event|Placebo|"IP Run-in Maintenance Phase (Weeks 0-9): Subjects randomized to receive placebo were given 3 doses of placebo matching IGIV-C by IV infusion at Baseline/Week 0 (Visit 1) and at Weeks 3 and 6 (Visits 2 and 3). The CS dose remained stable in this phase.~CS Tapering/IP Maintenance Phase (Weeks 9-36): Subjects continued to receive maintenance doses of placebo matching IGIV-C every third week from Week 9 (Visit 4) up to Week 36 (Visit 13). Prescribed CS tapering began at Week 9 (Visit 4) after the third maintenance dose of placebo was given. The last CS dose reduction was at Week 36 (Visit 13).~Safety/Follow-up Phase: Follow-up visits were at Weeks 39, 42 and 45 (Visits 14, 15 and 16). If considered medically indicated, the investigator could increase the CS dose after the Week 39 (Visit 14) assessments."
11239866|NCT02473991|BG000|Baseline|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
11362529|NCT01951378|EG000|Reported Event|Hudson RCI® Nebulizer|"Patients randomized to standard arm receive treatments by standard ED asthma pathway. Treatments administered with standard ED nebulizer, the Hudson RCI® Up-Draft® Neb-U-Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ), and a simple mask (Hudson RCI®, Teleflex Medical®, Research Triangle Park, NJ).~Hudson RCI® nebulizer: After 1 hour, patients in standard arm receive repeat assessment, including baseline measurements and reported side effects. Patients who score PAS 0-2 sent home, after optional observation period, per pathway. Those with score PAS > 2 receive second treatment, re-assessed, and repeat measurements. Based on patient's PAS score, he/she will be dispositioned home, the floor, the pulmonary high acuity unit (PHAU), or the pediatric intensive care unit (PICU).~Albuterol: Subjects may start treatment before consent and receive 2.5 mg. Albuterol/Proventil treatments by standard nebulizer <3 times as needed and may change to study randomized device once c"
11362530|NCT01951378|EG001|Reported Event|NebuTech® HDN® Nebulizer|"Patients randomized to NebuTech® arm will receive treatments as dictated by our trial pathway, referred to as the rapid Albuterol/Proventil delivery pathway (Fig. 2). All nebulizations in this arm will be administered via the Breath-Enhanced High Density Jet Nebulizer, NebuTech® HighDensityNebulizer®,(Salter Labs®, Arvin, CA). Respiratory Therapists (RT) will attempt to deliver all treatments with a mouthpiece, as that has been shown to be the most efficient and reliable mode of aerosol delivery for most children 31, 32. If the Respiratory Therapist feels that the child will not or cannot effectively use a mouthpiece, a mask will be used.~NebuTech® HDN® nebulizer: All treatments in the NebuTech® arm will be given at a standard dilution of 5 ml (diluted with normal saline to a total volume of 5 ml as per the manufacturer's recommendation). Patients in this arm will receive up to four treatments with parameters measured after each treatment, similar to the control arm. Patient"
11362531|NCT01941615|BG000|Baseline|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
11362532|NCT01941615|FG000|Participant Flow|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
11362533|NCT01941615|OG000|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
11362534|NCT01941615|EG000|Reported Event|Deleobuvir + Faldaprevir + Microgynon|"In the run-in period starting between Day -56 and Day -28, all subjects were to take 1 Microgynon® tablet (combined oral contraceptive ethinylestradiol / levonorgestrel) once daily for 21 to 49 days (depending on the menstrual cycle) until Day -8.~In the last 7 days of the run-in period (Day -7 to Day -1), no treatment was given in order to induce withdrawal bleeding. The next day was to be Day 1 of the study. Subjects who were using oral contraceptives before the study started the run-in period after the usual tablet-free interval of 7 days.~Subjects who were using hormonal contraceptive vaginal rings before the study started the run-in-period after the usual hormone-free interval of 7 days."
11362535|NCT01946542|BG000|Baseline|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
11362536|NCT01946542|BG001|Baseline|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
11362537|NCT01946542|BG002|Baseline|Total|Total of all reporting groups
11362538|NCT01946542|FG000|Participant Flow|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
11362539|NCT01946542|FG001|Participant Flow|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
11362540|NCT01946542|OG000|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
11362541|NCT01946542|OG001|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
11362542|NCT01946542|EG000|Reported Event|Placebo|
11362543|NCT01946542|EG001|Reported Event|Beet Juice Concentrate|
10962663|NCT00867789|EG000|Reported Event|Trimethoprim-sulfamethaxazole|"Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)~Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)"
11188760|NCT02115633|EG000|Reported Event|Walkasins ON Then OFF|"Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a 1 hour rest period they will be retested with Walkasins turned off.~Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.~Walkasins OFF: Subjects will be wearing a device that is turned off."
11362544|NCT01937507|BG000|Baseline|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
11362545|NCT01937507|FG000|Participant Flow|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
11362546|NCT01937507|OG000|Outcome|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
11362547|NCT01937507|EG000|Reported Event|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
11362548|NCT01944059|BG000|Baseline|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
11362549|NCT01944059|FG000|Participant Flow|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
11362550|NCT01944059|OG000|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
11362551|NCT01944059|OG001|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
11362552|NCT01944059|EG000|Reported Event|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
11362553|NCT01935947|BG000|Baseline|Arm I (Azacitidine, Entinostat, Chemotherapy)|Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses then patients receive chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10962664|NCT00867789|EG001|Reported Event|Sugar Pill|"Incision and drainage of the abscess and treatment with oral placebo (100 patients)~Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder."
11362554|NCT01935947|BG001|Baseline|Arm II (Azacitidine, Entinostat, Chemotherapy)|Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, and then patients receive chemotherapy as in Arm A.
11362555|NCT01935947|BG002|Baseline|Arm III (Chemotherapy)|Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
11362556|NCT01935947|BG003|Baseline|Total|Total of all reporting groups
11362557|NCT01935947|FG000|Participant Flow|Arm I (Azacitidine, Entinostat, Chemotherapy)|Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, then chemotherapy. Treatment repeats every 21 days.
11362558|NCT01935947|FG001|Participant Flow|Arm II (Azacitidine, Entinostat, Chemotherapy)|Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses. Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
11362559|NCT01935947|FG002|Participant Flow|Arm III (Chemotherapy)|Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
11362560|NCT01935947|OG000|Outcome|Arm I (Azacitidine, Entinostat, Chemotherapy)|"Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease receive chemotherapy of the treating oncologist's choice comprising irinotecan hydrochloride IV on day 1, docetaxel IV on day 1, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC~Docetaxel: Given IV~Entinostat: Given PO~Gemcitabine Hydrochloride: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11362561|NCT01935947|OG001|Outcome|Arm II (Azacitidine, Entinostat, Chemotherapy)|"Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease receive chemotherapy of the treating oncologist's choice as in Arm A.~Azacitidine: Given PO~Docetaxel: Given IV~Entinostat: Given PO~Gemcitabine Hydrochloride: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11362562|NCT01935947|OG002|Outcome|Arm III (Chemotherapy)|"Patients receive chemotherapy of the treating oncologist's choice as in Arm A.~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11362563|NCT01935947|OG000|Outcome|Arm I (Azacitidine, Entinostat, Chemotherapy)|Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, then chemotherapy. Treatment repeats every 21 days.
11362564|NCT01935947|OG001|Outcome|Arm II (Azacitidine, Entinostat, Chemotherapy)|Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses. Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
11362565|NCT01935947|OG002|Outcome|Arm III (Chemotherapy)|Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
11362566|NCT01935947|EG000|Reported Event|Arm I (Azacitidine, Entinostat, Chemotherapy)|Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 course, and then receive chemotherapy. Treatment repeats every 21 days.
11362567|NCT01935947|EG001|Reported Event|Arm II (Azacitidine, Entinostat, Chemotherapy)|Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, and then receive chemotherapy as in Arm A.
11362568|NCT01935947|EG002|Reported Event|Arm III (Chemotherapy)|Patients receive chemotherapy as in Arm A.
11362569|NCT01939223|BG000|Baseline|Regorafenib 160 mg|Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
11362570|NCT01939223|BG001|Baseline|Placebo|Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
11362571|NCT01939223|BG002|Baseline|Total|Total of all reporting groups
11362572|NCT01939223|FG000|Participant Flow|Regorafenib 160 mg|Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
11362573|NCT01939223|FG001|Participant Flow|Placebo|Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
11362574|NCT01939223|OG000|Outcome|Regorafenib 160 mg|Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
10849999|NCT00299494|EG004|Reported Event|Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 DLBCL|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
11362575|NCT01939223|OG001|Outcome|Placebo|Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
11362576|NCT01939223|EG000|Reported Event|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
11362577|NCT01939223|EG001|Reported Event|Placebo|Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
11362578|NCT01938716|BG000|Baseline|Intraoperative Gemcitabine Administration|Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
11362579|NCT01938716|FG000|Participant Flow|Intraoperative Gemcitabine Administration|Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
11362580|NCT01938716|OG000|Outcome|Intraoperative Gemcitabine Administration|Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
11362581|NCT01938716|EG000|Reported Event|Intraoperative Gemcitabine Administration|Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
11362582|NCT01936974|BG000|Baseline|Platinum, Gemcitabine and Bevacizumab|"Platinum:~Carboplatin* on day 1~*If a patient is allergic to carboplatin, then give~Cisplatin** on day 1~**If a patient is allergic to cisplatin and carboplatin, then give~Oxaliplatin on day 1~Gemcitabine on day 1 only~Bevacizumab on day 1~Gemcitabine~Bevacizumab~Carboplatin~Cisplatin~Oxaliplatin"
11362583|NCT01936974|BG001|Baseline|Gemcitabine and Bevacizumab|"Gemcitabine on days 1 and 8~Bevacizumab on day 1~Gemcitabine~Bevacizumab"
11362584|NCT01936974|BG002|Baseline|Total|Total of all reporting groups
11362585|NCT01936974|FG000|Participant Flow|Platinum, Gemcitabine and Bevacizumab|"Platinum:~Carboplatin* on day 1~*If a patient is allergic to carboplatin, then give~Cisplatin** on day 1~**If a patient is allergic to cisplatin and carboplatin, then give~Oxaliplatin on day 1~Gemcitabine on day 1 only~Bevacizumab on day 1~Gemcitabine~Bevacizumab~Carboplatin~Cisplatin~Oxaliplatin"
11362586|NCT01936974|FG001|Participant Flow|Gemcitabine and Bevacizumab|"Gemcitabine on days 1 and 8~Bevacizumab on day 1~Gemcitabine~Bevacizumab"
11362587|NCT01936974|OG000|Outcome|Platinum, Gemcitabine and Bevacizumab|"Platinum:~Carboplatin* on day 1~*If a patient is allergic to carboplatin, then give~Cisplatin** on day 1~**If a patient is allergic to cisplatin and carboplatin, then give~Oxaliplatin on day 1~Gemcitabine on day 1 only~Bevacizumab on day 1~Gemcitabine~Bevacizumab~Carboplatin~Cisplatin~Oxaliplatin"
11362588|NCT01936974|OG001|Outcome|Gemcitabine and Bevacizumab|"Gemcitabine on days 1 and 8~Bevacizumab on day 1~Gemcitabine~Bevacizumab"
11362589|NCT01936974|EG000|Reported Event|Platinum, Gemcitabine and Bevacizumab|"Platinum:~Carboplatin* on day 1~*If a patient is allergic to carboplatin, then give~Cisplatin** on day 1~**If a patient is allergic to cisplatin and carboplatin, then give~Oxaliplatin on day 1~Gemcitabine on day 1 only~Bevacizumab on day 1~Gemcitabine~Bevacizumab~Carboplatin~Cisplatin~Oxaliplatin"
11362590|NCT01936974|EG001|Reported Event|Gemcitabine and Bevacizumab|"Gemcitabine on days 1 and 8~Bevacizumab on day 1~Gemcitabine~Bevacizumab"
11362591|NCT01938833|BG000|Baseline|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
11362592|NCT01938833|FG000|Participant Flow|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
11362593|NCT01938833|OG000|Outcome|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
11362594|NCT01938833|EG000|Reported Event|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
11362595|NCT01934647|BG000|Baseline|1 mg MK-8892|Participants received a single oral dose of 1 mg MK-8892.
11362596|NCT01934647|BG001|Baseline|4 mg MK-8892|Participants received a single oral dose of 4 mg MK-8892.
11362597|NCT01934647|BG002|Baseline|8 mg MK-8892|Participants received a single oral dose of 8 mg MK-8892.
11362598|NCT01934647|BG003|Baseline|Total|Total of all reporting groups
11362599|NCT01934647|FG000|Participant Flow|1 mg MK-8892|Participants received a single oral dose of 1 mg MK-8892.
11362600|NCT01934647|FG001|Participant Flow|4 mg MK-8892|Participants received a single oral dose of 4 mg MK-8892.
11362601|NCT01934647|FG002|Participant Flow|8 mg MK-8892|Participants received a single oral dose of 8 mg MK-8892.
11362602|NCT01934647|OG000|Outcome|1 mg MK-8892|Participants received a single oral dose of 1 mg MK-8892.
11362603|NCT01934647|OG001|Outcome|4 mg MK-8892|Participants received a single oral dose of 4 mg MK-8892.
11362604|NCT01934647|OG002|Outcome|8 mg MK-8892|Participants received a single oral dose of 8 mg MK-8892.
11362605|NCT01934647|EG000|Reported Event|Panel A: 1 mg|Participants received a single oral dose of 1 mg MK-8892.
11362606|NCT01934647|EG001|Reported Event|Panel B: 4 mg|Participants received a single oral dose of 4 mg MK-8892.
11362607|NCT01934647|EG002|Reported Event|Panel C: 8 mg|Participants received a single oral dose of 8 mg MK-8892.
11362608|NCT01934504|BG000|Baseline|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362609|NCT01934504|BG001|Baseline|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362610|NCT01934504|BG002|Baseline|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362611|NCT01934504|BG003|Baseline|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects' primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
11362612|NCT01934504|BG004|Baseline|Total|Total of all reporting groups
11362613|NCT01934504|FG000|Participant Flow|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362614|NCT01934504|FG001|Participant Flow|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362615|NCT01934504|FG002|Participant Flow|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362616|NCT01934504|FG003|Participant Flow|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects' primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
11362617|NCT01934504|OG000|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362618|NCT01934504|OG001|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362619|NCT01934504|OG002|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362620|NCT01934504|OG003|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects' primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
11239867|NCT02473991|FG000|Participant Flow|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
11239868|NCT02473991|OG000|Outcome|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
11239869|NCT02473991|EG000|Reported Event|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
11239870|NCT02474069|BG000|Baseline|SP - Secukinumab 300 mg s.c. (4-weekly|In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16
11239871|NCT02474069|FG000|Participant Flow|SP - Secukinumab 300 mg s.c. (4-weekly)|In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
11239872|NCT02474069|FG001|Participant Flow|CDP - Secukinumab 300 mg s.c. (4-weekly)|In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
11239873|NCT02474069|FG002|Participant Flow|CDP - Secukinumab 300 mg s.c. (2-weekly)|In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
11239874|NCT02474069|OG000|Outcome|CDP - Secukinumab 300 mg s.c. (4-weekly)|In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
11239875|NCT02474069|OG001|Outcome|CDP - Secukinumab 300 mg s.c. (2-weekly)|In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
11239876|NCT02474069|OG000|Outcome|SP - Secukinumab 300 mg s.c. (4-weekly)|In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
11239877|NCT02474069|OG000|Outcome|Secukinumab 300 mg s.c. (4-weekly)|Patients received 300 mg s.c. secukinumab treatment every 4 weeks and placebo every 4 weeks
11239878|NCT02474069|OG000|Outcome|Secukinumab 300 mg s.c. (4-weekly)|Patients received 300 mg s.c. secukinumab treatment every 4 weeks and placebo every 4 weeks.
11239879|NCT02474069|EG000|Reported Event|SP-Secukinumab: AIN457 300 mg s.c. (4-weekly)|In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
11239880|NCT02474069|EG001|Reported Event|CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly)|In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
11239881|NCT02474069|EG002|Reported Event|CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly)|In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
11239882|NCT02474082|BG000|Baseline|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
11239883|NCT02474082|BG001|Baseline|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
11239884|NCT02474082|BG002|Baseline|Total|Total of all reporting groups
11239885|NCT02474082|FG000|Participant Flow|Secukinumab|Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel).
11239886|NCT02474082|FG001|Participant Flow|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
11362621|NCT01934504|EG000|Reported Event|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362622|NCT01934504|EG001|Reported Event|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362623|NCT01934504|EG002|Reported Event|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
11362624|NCT01934504|EG003|Reported Event|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects' primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
11362625|NCT01928082|BG000|Baseline|Transdermal Estradiol|"Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks~Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day"
11362626|NCT01928082|FG000|Participant Flow|Transdermal Estradiol|"Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks~Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day"
11362627|NCT01928082|OG000|Outcome|Transdermal Estradiol|"Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks~Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day"
11362628|NCT01928082|EG000|Reported Event|Transdermal Estradiol|"Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks~Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day"
11362629|NCT01928615|BG000|Baseline|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
11362630|NCT01928615|FG000|Participant Flow|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
11362631|NCT01928615|OG000|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
11362632|NCT01928615|OG001|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
11362633|NCT01928615|EG000|Reported Event|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
11362634|NCT01911793|BG000|Baseline|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
11362635|NCT01911793|BG001|Baseline|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
11362636|NCT01911793|BG002|Baseline|Total|Total of all reporting groups
11239887|NCT02474082|OG000|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
11239888|NCT02474082|OG001|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
11239889|NCT02474082|EG000|Reported Event|Secukinumab|Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel).
11239890|NCT02474082|EG001|Reported Event|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
11239891|NCT02474199|BG000|Baseline|Initiated Immunosuppression Withdrawal, Received darTregs|Initiated Immunosuppression Withdrawal, Received darTregs: Adult liver transplant recipients who signed informed consent, began immunosuppression withdrawal, and received the darTreg infusion. Adverse events were collected for these participants.
11239892|NCT02474199|BG001|Baseline|Initiated Immunosuppression Withdrawal, Did Not Receive darTregs|Initiated Immunosuppression Withdrawal, Did Not Receive darTregs: Adult liver transplant recipients who signed informed consent, began immunosuppression withdrawal, and did not receive the darTreg infusion. Adverse events were collected for these participants.
11239893|NCT02474199|BG002|Baseline|Total|Total of all reporting groups
11239894|NCT02474199|FG000|Participant Flow|Initiated Immunosuppression Withdrawal, Received darTregs|Initiated Immunosuppression Withdrawal, Received darTregs: Adult liver transplant recipients who signed informed consent, began immunosuppression withdrawal, and received the darTreg infusion. Adverse events were collected for these participants.
11239895|NCT02474199|FG001|Participant Flow|Initiated Immunosuppression Withdrawal, Did Not Receive darTregs|Initiated Immunosuppression Withdrawal, Did Not Receive darTregs: Adult liver transplant recipients who signed informed consent, began immunosuppression withdrawal, and did not receive the darTreg infusion. Adverse events were collected for these participants.
11239896|NCT02474199|FG002|Participant Flow|Did Not Initiate Withdrawal, Screening Biopsy Performed|Did Not Initiate Withdrawal, Screening Biopsy Performed: Adult liver transplant recipients who signed informed consent, had the protocol-mandated screening biopsy performed, and did not proceed to immunosuppression withdrawal. Adverse events were collected for these participants.
11239897|NCT02474199|FG003|Participant Flow|Did Not Initiate Withdrawal, Screening Biopsy Not Performed|"Did Not Initiate Withdrawal, Screening Biopsy Not Performed:~Adult liver transplant recipients who signed informed consent, did not have the protocol-mandated screening biopsy performed, and did not proceed to immunosuppression withdrawal. Adverse events were not collected for these participants."
11239898|NCT02474199|OG000|Outcome|Initiated Immunosuppression Withdrawal, Received darTregs|Initiated Immunosuppression Withdrawal, Received darTregs: Adult liver transplant recipients who signed informed consent, began immunosuppression withdrawal, and received the darTreg infusion. Adverse events were collected for these participants.
11239899|NCT02474199|OG000|Outcome|Initiated Immunosuppression Withdrawal|All participants who initiated immunosuppression withdrawal. Since both groups initiated immunosuppression withdrawal, the participants who received darTregs were combined with the participants who did not receive the darTreg infusion to form the pre-defined group for assessment of this outcome.
11239900|NCT02474199|EG000|Reported Event|Initiated Immunosuppression Withdrawal, Received darTregs|Initiated Immunosuppression Withdrawal, Received darTregs: Adult liver transplant recipients who signed informed consent, began immunosuppression withdrawal, and received the darTreg infusion. Adverse events were collected for these participants.
11239901|NCT02474199|EG001|Reported Event|Initiated Immunosuppression Withdrawal, Did Not Receive darTregs|Initiated Immunosuppression Withdrawal, Did Not Receive darTregs: Adult liver transplant recipients who signed informed consent, began immunosuppression withdrawal, and did not receive the darTreg infusion. Adverse events were collected for these participants.
11239902|NCT02474199|EG002|Reported Event|Did Not Initiate Withdrawal, Screening Biopsy Performed|Did Not Initiate Withdrawal, Screening Biopsy Performed: Adult liver transplant recipients who signed informed consent, had the protocol-mandated screening biopsy performed, and did not proceed to immunosuppression withdrawal. Adverse events were collected for these participants.
11240882|NCT02482675|FG000|Participant Flow|Glucose, Then Whey Protein, Then Sodium Caseinate, Then Milk|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240883|NCT02482675|FG001|Participant Flow|Glucose, Then Milk, Then Sodium Caseinate, Then Whey Protein|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11239903|NCT02474355|BG000|Baseline|Osimertinib|All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
11239904|NCT02474355|FG000|Participant Flow|Osimertinib|All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
11239905|NCT02474355|OG000|Outcome|Osimertinib|All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
11239906|NCT02474355|EG000|Reported Event|Osimertinib|All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
11239907|NCT02474407|BG000|Baseline|All Participants|DZNS (Diazepam Nasal Spray) vs DRG (Diazepam rectal gel)
11239908|NCT02474407|FG000|Participant Flow|Single Dose of Diazapam Nasal Spray (DZNS)|Subjects received a single dose diazepam nasal spray (DZNS) followed by a washout period of 14 days, after which a single dose of diazapam rectal gel (DRG) was administered.
11239909|NCT02474407|FG001|Participant Flow|Single Dose of Diazapam Rectal Gel (DRG)|Subjects received a single dose of Diazepam Rectal Gel (DRG) followed by a washout period of 14 days, after which a single dose of diazapam nasal spray (DZNS) was administered.
11239910|NCT02474407|OG000|Outcome|Single Dose of Diazapam Nasal Spray (DZNS)|Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
11239911|NCT02474407|OG001|Outcome|Single Dose of Diazapam Rectal Gel (DRG)|Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
11239912|NCT02474407|OG000|Outcome|DZNS - At 24 Hours Post-Dose - NONE|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239913|NCT02474407|OG001|Outcome|DZNS - At 24 Hours Post-Dose - Grade 1a|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239914|NCT02474407|OG002|Outcome|DZNS - At 24 Hours Post-Dose - Grade 1b|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239915|NCT02474407|OG003|Outcome|DZNS - At 24 Hours Post-Dose - Grade 2|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239916|NCT02474407|OG004|Outcome|DZNS - At 24 Hours Post-Dose - Grade 3|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239917|NCT02474407|OG005|Outcome|DZNS - At 24 Hours Post-Dose - Grade 4|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239918|NCT02474407|OG006|Outcome|DZNS - At 24 Hours Post-Dose - Missing|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239919|NCT02474407|OG000|Outcome|DZNS - At 24 Hours Post-Dose None|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239920|NCT02474407|OG001|Outcome|DZNS - At 24 Hours Post-Dose Mild|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239921|NCT02474407|OG002|Outcome|DZNS - At 24 Hours Post-Dose Moderate|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239922|NCT02474407|OG003|Outcome|DZNS - At 24 Hours Post-Dose Severe|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239923|NCT02474407|OG004|Outcome|DZNS - At 24 Hours Post-Dose Missing|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~diazepam nasal spray"
11239924|NCT02474407|OG000|Outcome|At Follow-Up Visit - Normosmia|Shift in SIT Scores in Cohort 1 from Treatment Period 1 (Prior to Dosing) to Follow-up Visit
11239925|NCT02474407|OG001|Outcome|At Follow-Up Visit - Mild Microsmia|Shift in SIT Scores in Cohort 1 from Treatment Period 1 (Prior to Dosing) to Follow-up Visit
11239926|NCT02474407|OG002|Outcome|At Follow-Up Visit - Moderate Microsmia|Shift in SIT Scores in Cohort 1 from Treatment Period 1 (Prior to Dosing) to Follow-up Visit
11239927|NCT02474407|OG003|Outcome|At Follow-Up Visit - Severe Microsmia|Shift in SIT Scores in Cohort 1 from Treatment Period 1 (Prior to Dosing) to Follow-up Visit
11239928|NCT02474407|OG004|Outcome|At Follow-Up Visit - Anosmia|Shift in SIT Scores in Cohort 1 from Treatment Period 1 (Prior to Dosing) to Follow-up Visit
11239929|NCT02474407|OG005|Outcome|At Follow-Up Visit - Probable Malingering|Shift in SIT Scores in Cohort 1 from Treatment Period 1 (Prior to Dosing) to Follow-up Visit
11239930|NCT02474407|OG006|Outcome|At Follow-Up Visit - Missing|Shift in SIT Scores in Cohort 1 from Treatment Period 1 (Prior to Dosing) to Follow-up Visit
11239931|NCT02474407|OG000|Outcome|Taste Change by Intensity in Cohort 1|Questionnaire for taste change associated with diazepam nasal spray dosing.
11239932|NCT02474407|EG000|Reported Event|Diazepam Nasal Spray|"One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~Diazepam Nasal Spray"
11239933|NCT02474407|EG001|Reported Event|Diazepam Rectal Gel|"A single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.~Diazepam Rectal Gel"
11239934|NCT02474498|BG000|Baseline|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11362637|NCT01911793|FG000|Participant Flow|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
11362638|NCT01911793|FG001|Participant Flow|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
11362639|NCT01911793|OG000|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
11362640|NCT01911793|OG001|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
11362641|NCT01911793|EG000|Reported Event|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
11362642|NCT01911793|EG001|Reported Event|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
11362643|NCT01912404|BG000|Baseline|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
11362644|NCT01912404|BG001|Baseline|Placebo|Matching Placebo capsules twice daily for 28 days
11362645|NCT01912404|BG002|Baseline|Total|Total of all reporting groups
11362646|NCT01912404|FG000|Participant Flow|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
11362647|NCT01912404|FG001|Participant Flow|Placebo|Matching Placebo capsules twice daily for 28 days
11362648|NCT01912404|OG000|Outcome|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
11362649|NCT01912404|OG001|Outcome|Placebo|Matching Placebo capsules twice daily for 28 days
11362650|NCT01912404|EG000|Reported Event|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
11362651|NCT01912404|EG001|Reported Event|Placebo|Matching Placebo capsules twice daily for 28 days
11362652|NCT01910389|BG000|Baseline|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
11362653|NCT01910389|BG001|Baseline|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
11362654|NCT01910389|BG002|Baseline|Total|Total of all reporting groups
11362655|NCT01910389|FG000|Participant Flow|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
11362656|NCT01910389|FG001|Participant Flow|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
11362657|NCT01910389|OG000|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
10963946|NCT00875056|BG000|Baseline|Follicular Lymphoma (FL)|Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
11362658|NCT01910389|OG001|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
11362659|NCT01910389|EG000|Reported Event|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
11362660|NCT01910389|EG001|Reported Event|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
11362661|NCT01921114|BG000|Baseline|BioFlo™ PICC|BioFlo™ Peripherally Inserted Central Catheter (PICC)
11362662|NCT01921114|BG001|Baseline|Bard® PowerPICC SOLO2®|Bard® Dual-Lumen PowerPICC SOLO2®
11362663|NCT01921114|BG002|Baseline|Total|Total of all reporting groups
11362664|NCT01921114|FG000|Participant Flow|BioFlo™ PICC|"BioFlo™ Peripherally Inserted Central Catheter (PICC)~BioFlo™ Peripherally Inserted Central Catheter (PICC)"
11362665|NCT01921114|FG001|Participant Flow|Bard® PowerPICC SOLO2®|"Bard® Dual-Lumen PowerPICC SOLO2®~Bard® Dual-Lumen PowerPICC SOLO2®"
11362666|NCT01921114|OG000|Outcome|BioFlo™ PICC|BioFlo™ Peripherally Inserted Central Catheter (PICC)
11362667|NCT01921114|OG001|Outcome|Bard® PowerPICC SOLO2®|Bard® Dual-Lumen PowerPICC SOLO2®
11362668|NCT01921114|EG000|Reported Event|BioFlo™ PICC|BioFlo™ Peripherally Inserted Central Catheter (PICC)
11362669|NCT01921114|EG001|Reported Event|Bard® PowerPICC SOLO2®|Bard® Dual-Lumen PowerPICC SOLO2®
11362670|NCT01916590|BG000|Baseline|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
11362671|NCT01916590|BG001|Baseline|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
11362672|NCT01916590|BG002|Baseline|Total|Total of all reporting groups
11362673|NCT01916590|FG000|Participant Flow|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
11362674|NCT01916590|FG001|Participant Flow|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
11362675|NCT01916590|OG000|Outcome|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
11362676|NCT01916590|OG001|Outcome|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
11362677|NCT01916590|EG000|Reported Event|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
11362678|NCT01916590|EG001|Reported Event|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
11362679|NCT01913327|BG000|Baseline|Aripiprazole|"aripiprazole with flexible, blind dosing between 7.5 mg and 30 mg, once daily.~Aripiprazole~Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication."
11362680|NCT01913327|BG001|Baseline|Risperidone|"risperidone with flexible, blind dosing between 1 mg and 8 mg, once daily.~Risperidone: Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd.~Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication."
11362681|NCT01913327|BG002|Baseline|Total|Total of all reporting groups
10849894|NCT00299130|FG002|Participant Flow|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11362682|NCT01913327|FG000|Participant Flow|Aripiprazole|"aripiprazole with flexible, blind dosing between 7.5 mg and 30 mg, once daily.~Aripiprazole~Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication."
11362683|NCT01913327|FG001|Participant Flow|Risperidone|"risperidone with flexible, blind dosing between 1 mg and 8 mg, once daily.~Risperidone: Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd.~Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication."
11362684|NCT01913327|OG000|Outcome|Aripiprazole|"aripiprazole with flexible, blind dosing between 7.5 mg and 30 mg, once daily.~Aripiprazole~Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication."
11362685|NCT01913327|OG001|Outcome|Risperidone|"risperidone with flexible, blind dosing between 1 mg and 8 mg, once daily.~Risperidone: Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd.~Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication."
11362686|NCT01913327|EG000|Reported Event|Aripiprazole|"aripiprazole with flexible, blind dosing between 7.5 mg and 30 mg, once daily.~Aripiprazole~Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication."
11362687|NCT01913327|EG001|Reported Event|Risperidone|"risperidone with flexible, blind dosing between 1 mg and 8 mg, once daily.~Risperidone: Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd.~Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication."
11362688|NCT01902888|BG000|Baseline|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
11362689|NCT01902888|FG000|Participant Flow|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
11362690|NCT01902888|OG000|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
11362691|NCT01902888|EG000|Reported Event|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
11362692|NCT01901224|BG000|Baseline|Overall Study|Overall Study (Metformin and Placebo arms combined)
11362693|NCT01901224|FG000|Participant Flow|Overall Study|Overall Study (Metformin and Placebo arms combined)
11362694|NCT01901224|OG000|Outcome|Overall Study|Overall Study (Metformin and Placebo arms combined)
11362695|NCT01901224|EG000|Reported Event|Overall Study|Overall Study (Metformin and Placebo arms combined)
11362696|NCT01910441|BG000|Baseline|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
11362697|NCT01910441|BG001|Baseline|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
11362698|NCT01910441|BG002|Baseline|Total|Total of all reporting groups
11362699|NCT01910441|FG000|Participant Flow|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
11362700|NCT01910441|FG001|Participant Flow|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
11362701|NCT01910441|OG000|Outcome|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
11362702|NCT01910441|OG001|Outcome|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
11362703|NCT01910441|EG000|Reported Event|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
10963947|NCT00875056|BG001|Baseline|Indolent Non-FL B-NHL or MCL|Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
11362704|NCT01910441|EG001|Reported Event|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
11362705|NCT01902966|BG000|Baseline|Propranolol + Relaxation/Guided Imagery|A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
11362706|NCT01902966|FG000|Participant Flow|Propranolol + Relaxation/Guided Imagery|A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
11362707|NCT01902966|OG000|Outcome|Propranolol + Relaxation/Guided Imagery|A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
11362708|NCT01902966|EG000|Reported Event|Propranolol + Relaxation/Guided Imagery|A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
11362709|NCT01901679|BG000|Baseline|3 Day run-in Period|After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
11362710|NCT01901679|BG001|Baseline|14 Day run-in Period|After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
11362711|NCT01901679|BG002|Baseline|Total|Total of all reporting groups
11362712|NCT01901679|FG000|Participant Flow|1st Group: 3 Day run-in Period|After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
11362713|NCT01901679|FG001|Participant Flow|2nd Group: 14 Day run-in Period|After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
11362714|NCT01901679|OG000|Outcome|1st Group: 3 Day run-in Period|After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
11362715|NCT01901679|OG001|Outcome|2nd Group: 14 Day run-in Period|After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
11239935|NCT02474498|BG001|Baseline|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
11239936|NCT02474498|BG002|Baseline|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239937|NCT02474498|BG003|Baseline|Total|Total of all reporting groups
11239938|NCT02474498|FG000|Participant Flow|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239939|NCT02474498|FG001|Participant Flow|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239940|NCT02474498|FG002|Participant Flow|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
11239941|NCT02474498|OG000|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239942|NCT02474498|OG001|Outcome|βTCP/HA + EMD|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239943|NCT02474498|OG002|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239944|NCT02474498|OG001|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
11362716|NCT01901679|EG000|Reported Event|1st Group: 3 Day run-in Period|After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
11362717|NCT01901679|EG001|Reported Event|2nd Group: 14 Day run-in Period|After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
11362718|NCT01900730|BG000|Baseline|Group 1|Group 1 will take placebo 3 times a day for 10 weeks while an indwelling pleural catheter drains pleural fluid.
11362719|NCT01900730|BG001|Baseline|Group 2|Group 2 will take valproic acid (VPA) 3 times a day for a total of 10 weeks while an indwelling pleural catheter drains pleural fluid.
11362720|NCT01900730|BG002|Baseline|Total|Total of all reporting groups
11362721|NCT01900730|FG000|Participant Flow|Group 1|Group 1 will take placebo 3 times a day for 10 weeks while an indwelling pleural catheter drains pleural fluid.
11362722|NCT01900730|FG001|Participant Flow|Group 2|Group 2 will take valproic acid (VPA) 3 times a day for a total of 10 weeks while an indwelling pleural catheter drains pleural fluid.
11362723|NCT01900730|OG000|Outcome|Group 1|Group 1 will take placebo 3 times a day for 10 weeks while an indwelling pleural catheter drains pleural fluid.
11362724|NCT01900730|OG001|Outcome|Group 2|Group 2 will take valproic acid (VPA) 3 times a day for a total of 10 weeks while an indwelling pleural catheter drains pleural fluid.
11362725|NCT01900730|EG000|Reported Event|Group 1|Group 1 will take placebo 3 times a day for 10 weeks while an indwelling pleural catheter drains pleural fluid.
11362726|NCT01900730|EG001|Reported Event|Group 2|Group 2 will take valproic acid (VPA) 3 times a day for a total of 10 weeks while an indwelling pleural catheter drains pleural fluid.
11362727|NCT01877564|BG000|Baseline|Group 1 - Metformin|"oral metformin at 500 mg twice a day for 14-21 days followed by surgery~Metformin"
11362728|NCT01877564|BG001|Baseline|Group 2 - No Treatment|no metformin for 14-21 days
11362729|NCT01877564|BG002|Baseline|Total|Total of all reporting groups
11362730|NCT01877564|FG000|Participant Flow|Group 1 - Metformin|"oral metformin at 500 mg twice a day for 14-21 days followed by surgery~Metformin"
11362731|NCT01877564|FG001|Participant Flow|Group 2 - No Treatment|no metformin for 14-21 days
11362732|NCT01877564|OG000|Outcome|Group 1 - Metformin|"oral metformin at 500 mg twice a day for 14-21 days followed by surgery~Metformin"
11362733|NCT01877564|OG001|Outcome|Group 2 - No Treatment|no metformin for 14-21 days
11362734|NCT01877564|EG000|Reported Event|Group 1 - Metformin|"oral metformin at 500 mg twice a day for 14-21 days followed by surgery~Metformin"
11362735|NCT01877564|EG001|Reported Event|Group 2 - No Treatment|no metformin for 14-21 days
11362736|NCT01890694|BG000|Baseline|Placebo|Subjects will receive placebo once daily.
11362737|NCT01890694|BG001|Baseline|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
11362738|NCT01890694|BG002|Baseline|Total|Total of all reporting groups
11362739|NCT01890694|FG000|Participant Flow|Placebo|Subjects will receive placebo once daily.
11362740|NCT01890694|FG001|Participant Flow|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
11362741|NCT01890694|OG000|Outcome|Placebo|Subjects will receive placebo once daily.
11362742|NCT01890694|OG001|Outcome|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
11362743|NCT01890694|OG000|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
11362744|NCT01890694|OG001|Outcome|Placebo|Study Terminated. No data analyzed
11362745|NCT01890694|EG000|Reported Event|Placebo|Subjects will receive placebo once daily.
11362746|NCT01890694|EG001|Reported Event|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
11362747|NCT01900626|BG000|Baseline|Single Epidural Catheter|
11362748|NCT01900626|BG001|Baseline|Double Epidural Catheter|
11362749|NCT01900626|BG002|Baseline|Total|Total of all reporting groups
11362750|NCT01900626|FG000|Participant Flow|Single Epidural Catheter|
11362751|NCT01900626|FG001|Participant Flow|Double Epidural Catheter|
11362752|NCT01900626|OG000|Outcome|Single Epidural Catheter|epidural catheter: epidural catheter with 0.3% ropivacaine
11362753|NCT01900626|OG001|Outcome|Double Epidural Catheter|epidural catheter: epidural catheter with 0.3% ropivacaine
11362754|NCT01900626|OG000|Outcome|Single Epidural Catheter|
11362755|NCT01900626|OG001|Outcome|Double Epidural Catheter|
11362756|NCT01900626|EG000|Reported Event|Single Epidural Catheter|This study is being closed due to difficulty with enrollment and changes to standard of care. No data on serious adverse events was collected
11362757|NCT01900626|EG001|Reported Event|Double Epidural Catheter|This study is being closed due to difficulty with enrollment and changes to standard of care. No data on serious adverse events was collected
11362758|NCT01890577|BG000|Baseline|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
11362759|NCT01890577|FG000|Participant Flow|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
11362760|NCT01890577|OG000|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
11362761|NCT01890577|EG000|Reported Event|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
11362762|NCT01895959|BG000|Baseline|Treatment|Subjects treated with Euflexxa
11362763|NCT01895959|FG000|Participant Flow|Treatment|Subjects treated with Euflexxa
11362764|NCT01895959|OG000|Outcome|Treatment|Subjects treated with Euflexxa
11362765|NCT01895959|EG000|Reported Event|Treatment|Subjects treated with Euflexxa
11362766|NCT01889420|BG000|Baseline|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
11362767|NCT01889420|FG000|Participant Flow|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
11362768|NCT01889420|OG000|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
11362769|NCT01889420|EG000|Reported Event|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
11362770|NCT01884077|BG000|Baseline|Reverse Shoulder Arthroplasty|"Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder~Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component."
11362771|NCT01884077|BG001|Baseline|Total Shoulder Arthroplasty|"Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint~Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus)."
11362772|NCT01884077|BG002|Baseline|Total|Total of all reporting groups
11362773|NCT01884077|FG000|Participant Flow|Reverse Shoulder Arthroplasty|"Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder~Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component."
11362774|NCT01884077|FG001|Participant Flow|Total Shoulder Arthroplasty|"Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint~Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus)."
11362775|NCT01884077|OG000|Outcome|Reverse Shoulder Arthroplasty|"Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder~Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component."
11362776|NCT01884077|OG001|Outcome|Total Shoulder Arthroplasty|"Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint~Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus)."
11362777|NCT01884077|EG000|Reported Event|Reverse Shoulder Arthroplasty|"Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder~Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component."
11362778|NCT01884077|EG001|Reported Event|Total Shoulder Arthroplasty|"Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint~Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus)."
11362779|NCT01881984|BG000|Baseline|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
11362780|NCT01881984|FG000|Participant Flow|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
11362781|NCT01881984|OG000|Outcome|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
11362782|NCT01881984|EG000|Reported Event|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
11362783|NCT01893359|BG000|Baseline|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
11362784|NCT01893359|BG001|Baseline|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
11362785|NCT01893359|BG002|Baseline|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
11362786|NCT01893359|BG003|Baseline|Total|Total of all reporting groups
11362787|NCT01893359|FG000|Participant Flow|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
11362788|NCT01893359|FG001|Participant Flow|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
11362789|NCT01893359|FG002|Participant Flow|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
11362790|NCT01893359|OG000|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
11362791|NCT01893359|OG001|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
11362792|NCT01893359|OG002|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
11362793|NCT01893359|EG000|Reported Event|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
11362794|NCT01893359|EG001|Reported Event|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
10962665|NCT00867815|BG000|Baseline|PDE5 Inhibitor Use & Risk of NAION|Participants were assessed at 2 visits. Visit 1 (Day 1) included screening, confirmation of the diagnosis of NAION, enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90+/-30) was a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION. No interventional treatment was administered in the context of this study.
11362795|NCT01893359|EG002|Reported Event|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
11376261|NCT00980460|BG002|Baseline|Intermediate-risk Group (Regimen F)|"Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)~Cisplatin: Given IV~Dexrazoxane: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11362796|NCT01883908|BG000|Baseline|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
11362797|NCT01883908|BG001|Baseline|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
11362798|NCT01883908|BG002|Baseline|Total|Total of all reporting groups
11362799|NCT01883908|FG000|Participant Flow|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
11362800|NCT01883908|FG001|Participant Flow|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
11362801|NCT01883908|OG000|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
11362802|NCT01883908|OG001|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
11362803|NCT01883908|EG000|Reported Event|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
11362804|NCT01883908|EG001|Reported Event|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
11362805|NCT01887288|BG000|Baseline|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
11362806|NCT01887288|FG000|Participant Flow|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
11362807|NCT01887288|OG000|Outcome|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
11362808|NCT01887288|EG000|Reported Event|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
11362809|NCT01881932|BG000|Baseline|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
11376262|NCT00980460|BG003|Baseline|High-risk Group (Regimen W)|"(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11362810|NCT01881932|BG001|Baseline|Acupuncture|Pts stratified based on cancer (breast cancer vs colorectal cancer). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get addiinl therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly til the end of chemo. Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to the surface of the same points with adhesive tape, w
11362811|NCT01881932|BG002|Baseline|Sham Acupuncture|"Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get sham acupuncture until the end of their chemo while following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels.~Sham Acupuncture using Park Sham placebo acupuncture device: Participants will get sham acupuncture until the end of chemo.~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. She will tap a mock plastic needle gui"
11362812|NCT01881932|BG003|Baseline|Total|Total of all reporting groups
11362813|NCT01881932|FG000|Participant Flow|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
11362814|NCT01881932|FG001|Participant Flow|Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). Patients will be randomly assigned to receive acupuncture until the end of their chemotherapy. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not receive additional therapy for CIPN.~Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.~Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points, and"
11362815|NCT01881932|FG002|Participant Flow|Sham Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive sham acupuncture until the end of their chemotherapy while following the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels.~Sham Acupuncture using Park Sham placebo acupuncture device: Participants will receive sham acupuncture until the end of chemotherapy.~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape"
11362816|NCT01881932|OG000|Outcome|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
11362817|NCT01881932|OG001|Outcome|Acupuncture|Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week & all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get additional therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly until the end of chemotherapy. Subjects will get acupuncture at documented acupoints. To improve blinding effect, acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to surface of the same points with adhesive tape, no needle insertion.
10962666|NCT00867815|FG000|Participant Flow|PDE5 Inhibitor Use & Risk of NAION|Participants were assessed at 2 visits. Visit 1 (Day 1) included screening, confirmation of the diagnosis of NAION, enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90+/-30) was a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION. No interventional treatment was administered in the context of this study.
11362818|NCT01881932|OG002|Outcome|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). Patients to get sham acupuncture til the end of their chemo & following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Pt complete a wkly questionnaire to determine severity of nerve pain symptoms. Each wk record the total amount of chemo in the past week & all together. Each wk patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device of a retractable needle & an adhesive tube into sham points &apply 2 pieces of adhesive tape next to needles; will tap a mock plastic needle guiding tube on surface of each of 8 true points in the arm & leg to produce some discernible sensation & then apply needle w/ piece of adhesive tape to dermal surface, w/out needle insertion.
11362819|NCT01881932|EG000|Reported Event|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
11362820|NCT01881932|EG001|Reported Event|Acupuncture|"Patients stratified based on cancer (breast vs colorectal). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not get additional therapy for CIPN.~Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.~Subjects will get acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will tap 2 guiding tubes at 2 sham points & affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion."
11362821|NCT01881932|EG002|Reported Event|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). The patients get sham acupuncture til the end of chemo with same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient complete a weekly questionnaire to determine severity of nerve pain symptoms. Weekly record total amount of chemo received in the past week & all together. Each week patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle & adhesive tube into the sham points, & then apply 2 pieces of adhesive tape next to needles. Will tap mock plastic needle guiding tube on the surface of each of 8 true points in arm & leg to produce sensation & apply a needle with piece of adhesive tape to dermal surface, no needle insertion.
11362822|NCT01878786|BG000|Baseline|ERL & TAC|"Concentration controlled everolimus(ERL) & Low dose tacrolimus(TAC) + corticosteroid withdraw~Everolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .~Tacrolimus: CNI"
11362823|NCT01878786|BG001|Baseline|ERL & TAC --> MMF/MPA|"Concentration controlled everolimus & low dose tacrolimus --> mycophenolate mofetil (MMF) at Month 3 + corticosteroid withdraw~Everolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .~Tacrolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus."
11362824|NCT01878786|BG002|Baseline|Standard Dose TAC + MMF/MPA|"Standard dose of tacrolimus + mycophenolate mofetil + corticosteroid withdraw~Tacrolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus.~Mycophenolate mofetil (MMF/MPA): Control Drug"
11362825|NCT01878786|BG003|Baseline|Total|Total of all reporting groups
11362826|NCT01878786|FG000|Participant Flow|ERL & TAC|"Concentration controlled everolimus(ERL) & Low dose tacrolimus(TAC) + corticosteroid withdraw~Everolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .~Tacrolimus: CNI"
11362827|NCT01878786|FG001|Participant Flow|ERL & TAC --> MMF/MPA|"Concentration controlled everolimus & low dose tacrolimus --> mycophenolate mofetil (MMF) at Month 3 + corticosteroid withdraw~Everolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .~Tacrolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus."
11362828|NCT01878786|FG002|Participant Flow|Standard Dose TAC + MMF/MPA|"Standard dose of tacrolimus + mycophenolate mofetil + corticosteroid withdraw~Tacrolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus.~Mycophenolate mofetil (MMF/MPA): Control Drug"
11362829|NCT01878786|OG000|Outcome|ERL & TAC|"Concentration controlled everolimus(ERL) & Low dose tacrolimus(TAC) + corticosteroid withdraw~Everolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .~Tacrolimus: CNI"
11362830|NCT01878786|OG001|Outcome|ERL & TAC --> MMF/MPA|"Concentration controlled everolimus & low dose tacrolimus --> mycophenolate mofetil (MMF) at Month 3 + corticosteroid withdraw~Everolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .~Tacrolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus."
11362831|NCT01878786|OG002|Outcome|Standard Dose TAC + MMF/MPA|"Standard dose of tacrolimus + mycophenolate mofetil + corticosteroid withdraw~Tacrolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus.~Mycophenolate mofetil (MMF/MPA): Control Drug"
11362832|NCT01878786|EG000|Reported Event|ERL & TAC|"Concentration controlled everolimus(ERL) & Low dose tacrolimus(TAC) + corticosteroid withdraw~Everolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .~Tacrolimus: CNI"
11362833|NCT01878786|EG001|Reported Event|ERL & TAC --> MMF/MPA|"Concentration controlled everolimus & low dose tacrolimus --> mycophenolate mofetil (MMF) at Month 3 + corticosteroid withdraw~Everolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .~Tacrolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus."
11362834|NCT01878786|EG002|Reported Event|Standard Dose TAC + MMF/MPA|"Standard dose of tacrolimus + mycophenolate mofetil + corticosteroid withdraw~Tacrolimus: One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus.~Mycophenolate mofetil (MMF/MPA): Control Drug"
11188761|NCT02115633|EG001|Reported Event|Walkasins OFF Then ON|"Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a 1 hour rest period they will be retested with Walkasins turned on.~Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.~Walkasins OFF: Subjects will be wearing a device that is turned off."
11188762|NCT02115646|BG000|Baseline|Fractionated CO2 Laser Treatment|"Fractionated carbon dioxide laser~Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments."
11188763|NCT02115646|FG000|Participant Flow|Fractionated CO2 Laser Treatment|"Fractionated carbon dioxide laser~Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments."
11188764|NCT02115646|OG000|Outcome|Baseline|Characteristics of study population at baseline.
11188765|NCT02115646|OG001|Outcome|15-months|Characteristics of study population at conclusion of study.
11362835|NCT01877343|BG000|Baseline|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362836|NCT01877343|BG001|Baseline|Pediatric Heart Transplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362837|NCT01877343|BG002|Baseline|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362838|NCT01877343|BG003|Baseline|Total|Total of all reporting groups
11362839|NCT01877343|FG000|Participant Flow|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362840|NCT01877343|FG001|Participant Flow|Pediatric Heart Tansplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11188766|NCT02115646|OG000|Outcome|Baseline|Characteristics of study population at baseline
11188767|NCT02115646|OG001|Outcome|15-months|Characteristics of study population at conclusion of study
11188768|NCT02115646|OG001|Outcome|15-months|Characteristics of study population at 15-months
11188769|NCT02115646|OG001|Outcome|15-months|Characteristics of study population at 15-months.
11362841|NCT01877343|FG002|Participant Flow|Adult Heart Failure|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11188770|NCT02115646|EG000|Reported Event|Fractionated CO2 Laser Treatment|"Fractionated carbon dioxide laser~Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments."
11188771|NCT02115750|BG000|Baseline|Enbrel (Etanercept)|"Enbrel 50mg weekly times 24 weeks.~Etanercept: Head-to-head comparison"
11188772|NCT02115750|BG001|Baseline|CHS-0214|"CHS-0214 50mg weekly times 24 weeks.~CHS-0214"
11188773|NCT02115750|BG002|Baseline|Total|Total of all reporting groups
11188774|NCT02115750|FG000|Participant Flow|Enbrel (Etanercept)|"Enbrel 50mg subcutaneously every week for 24 Weeks.~Etanercept: Head-to-head comparison~In part 2, all subjects received 50mg subcutaneously every week from week 25-48."
11188775|NCT02115750|FG001|Participant Flow|CHS-0214|"CHS-0214 50mg subcutaneously every week for 24 Weeks.~Part 2: All subjects received CHS-0214 50mg subcutaneously every week from week 25-48."
11188776|NCT02115750|OG000|Outcome|Enbrel (Etanercept)|"Enbrel 50mg weekly times 24 weeks.~Etanercept: Head-to-head comparison"
11188777|NCT02115750|OG001|Outcome|CHS-0214|"CHS-0214 50mg weekly times 24 weeks.~CHS-0214"
11188778|NCT02115750|OG000|Outcome|Enbrel (Etanercept)|"Enbrel 50mg subcutaneously every week for 24 Weeks.~Etanercept: Head-to-head comparison~In part 2, all subjects received 50mg subcutaneously every week from week 25-48."
11188779|NCT02115750|OG001|Outcome|CHS-0214|"CHS-0214 50mg subcutaneously every week for 24 Weeks.~Part 2: All subjects received CHS-0214 50mg subcutaneously every week from week 25-48."
11362842|NCT01877343|FG003|Participant Flow|Adult Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362843|NCT01877343|FG004|Participant Flow|Pediatric Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362844|NCT01877343|FG005|Participant Flow|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362845|NCT01877343|FG006|Participant Flow|Adult Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362846|NCT01877343|OG000|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362847|NCT01877343|EG000|Reported Event|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
11362848|NCT01861717|BG000|Baseline|Somatuline Depot SC|"Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.~lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses"
11362849|NCT01861717|FG000|Participant Flow|Somatuline Depot Subcutaneous (SC)|"Somatuline Depot Subcutaneous (SC) 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.~lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses"
11362850|NCT01861717|OG000|Outcome|Somatuline Depot Subcutaneous (SC)|"Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.~lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses"
11362851|NCT01861717|OG000|Outcome|Somatuline Depot SC|"Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.~lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses"
11362852|NCT01861717|EG000|Reported Event|Somatuline Depot SC|"Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.~lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses"
11362853|NCT01866709|BG000|Baseline|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE)~Total Study Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Total Randomized (n= 32 )~Allocated to intervention (n= 15 ): ACTIVE~Received allocated intervention (n= 15)~Did not receive allocated intervention (give reasons) (n= 0 )~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention before study terminated (n= 1): non-serious adverse event~Analysed (n= 0)~◻ Excluded from analysis (give reasons) (n= 15): study terminated early due to safety reasons"
11362854|NCT01866709|BG001|Baseline|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO)~Total Study Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Total Randomized (n= 32 )~Allocated to intervention (n= 17): PLACEBO~Received allocated intervention (n= 17 )~Did not receive allocated intervention (give reasons) (n= 0)~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention (give reasons) (n= 0)~Analysed (n= 0)~◻ Excluded from analysis (give reasons) (n= 17): study terminated early due to safety reasons"
11362855|NCT01866709|BG002|Baseline|Total|Total of all reporting groups
11362856|NCT01866709|FG000|Participant Flow|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Randomized (n= 32 )~Allocated to intervention (n= 15 ): ACTIVE~Received allocated intervention (n= 15)~Did not receive allocated intervention (give reasons) (n= 0 )~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention before study terminated (n= 1): non-serious adverse event~Analyzed (n= 0)~◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
11362857|NCT01866709|FG001|Participant Flow|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Randomized (n= 32 )~Allocated to intervention (n= 17): PLACEBO~Received allocated intervention (n= 17 )~Did not receive allocated intervention (give reasons) (n= 0)~Lost to follow-up (give reasons) (n= 0 )~Analyzed (n= 0)~◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
11362858|NCT01866709|OG000|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate"
11362859|NCT01866709|OG001|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose"
11362860|NCT01866709|EG000|Reported Event|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
11362861|NCT01866709|EG001|Reported Event|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
11362862|NCT01860040|BG000|Baseline|Cisplatin and Pemetrexed|"Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Pemetrexed"
11362863|NCT01860040|BG001|Baseline|Cisplatin and Gemcitabine|"Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Gemcitabine"
11362864|NCT01860040|BG002|Baseline|Total|Total of all reporting groups
11362865|NCT01860040|FG000|Participant Flow|Cisplatin and Pemetrexed|"Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Pemetrexed"
11362866|NCT01860040|FG001|Participant Flow|Cisplatin and Gemcitabine|"Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Gemcitabine"
11362867|NCT01860040|OG000|Outcome|Cisplatin and Pemetrexed|"Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Pemetrexed"
11362868|NCT01860040|EG000|Reported Event|Cisplatin and Pemetrexed|"Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Pemetrexed"
11362869|NCT01860040|EG001|Reported Event|Cisplatin and Gemcitabine|"Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Gemcitabine"
11362870|NCT01869478|BG000|Baseline|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
11362871|NCT01869478|BG001|Baseline|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
11362872|NCT01869478|BG002|Baseline|Total|Total of all reporting groups
11362873|NCT01869478|FG000|Participant Flow|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
11362874|NCT01869478|FG001|Participant Flow|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
11362875|NCT01869478|OG000|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
11362876|NCT01869478|OG001|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
11362877|NCT01869478|EG000|Reported Event|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
11362878|NCT01869478|EG001|Reported Event|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
11362879|NCT01851174|BG000|Baseline|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
11362880|NCT01851174|FG000|Participant Flow|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
11362881|NCT01851174|OG000|Outcome|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
11362882|NCT01851174|EG000|Reported Event|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
11362883|NCT01846182|BG000|Baseline|Group 1|"60 mg of duloxetine in the AM for 20 weeks~Duloxetine: serotonin norepinephrine reuptake inhibitor~Placebo: Placebo"
11362884|NCT01846182|BG001|Baseline|Group 2|"300 mg of pregabalin in the PM for 20 weeks~Pregabalin: alpha-2-alpha subunit calcium channel ligand~Placebo: Placebo"
11362885|NCT01846182|BG002|Baseline|Group 3|"placebo in the AM & PM for 20 weeks~Placebo: Placebo"
11362886|NCT01846182|BG003|Baseline|Total|Total of all reporting groups
11362887|NCT01846182|FG000|Participant Flow|Group 1|"60 mg of duloxetine in the AM for 20 weeks~Duloxetine: serotonin norepinephrine reuptake inhibitor~Placebo: Placebo"
11362888|NCT01846182|FG001|Participant Flow|Group 2|"300 mg of pregabalin in the PM for 20 weeks~Pregabalin: alpha-2-alpha subunit calcium channel ligand~Placebo: Placebo"
11362889|NCT01846182|FG002|Participant Flow|Group 3|"placebo in the AM & PM for 20 weeks~Placebo: Placebo"
11362890|NCT01846182|OG000|Outcome|Group 1|"60 mg of duloxetine in the AM for 20 weeks and placebo in PM~Duloxetine: serotonin norepinephrine reuptake inhibitor~Placebo: Placebo"
11362891|NCT01846182|OG001|Outcome|Group 2|"300 mg of pregabalin in the PM for 20 weeks and placebo in AM~Pregabalin: alpha-2-alpha subunit calcium channel ligand~Placebo: Placebo"
11362892|NCT01846182|OG002|Outcome|Group 3|"placebo in the AM & PM for 20 weeks~Placebo: Placebo"
11362893|NCT01846182|OG000|Outcome|Group 1|"60 mg of duloxetine in the AM for 20 weeks~Duloxetine: serotonin norepinephrine reuptake inhibitor~Placebo: Placebo"
11362894|NCT01846182|OG001|Outcome|Group 2|"300 mg of pregabalin in the PM for 20 weeks~Pregabalin: alpha-2-alpha subunit calcium channel ligand~Placebo: Placebo"
11362895|NCT01846182|EG000|Reported Event|Group 1|"60 mg of duloxetine in the AM for 20 weeks~Duloxetine: serotonin norepinephrine reuptake inhibitor~Placebo: Placebo"
11362896|NCT01846182|EG001|Reported Event|Group 2|"300 mg of pregabalin in the PM for 20 weeks~Pregabalin: alpha-2-alpha subunit calcium channel ligand~Placebo: Placebo"
11362897|NCT01846182|EG002|Reported Event|Group 3|"placebo in the AM & PM for 20 weeks~Placebo: Placebo"
11362898|NCT01844206|BG000|Baseline|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
11362899|NCT01844206|BG001|Baseline|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
11362900|NCT01844206|BG002|Baseline|Total|Total of all reporting groups
11362901|NCT01844206|FG000|Participant Flow|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
11362902|NCT01844206|FG001|Participant Flow|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
11362903|NCT01844206|OG000|Outcome|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
11362904|NCT01844206|OG001|Outcome|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
11362905|NCT01844206|EG000|Reported Event|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
11362906|NCT01844206|EG001|Reported Event|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
11362907|NCT01856322|BG000|Baseline|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
11362908|NCT01856322|BG001|Baseline|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
11362909|NCT01856322|BG002|Baseline|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
11362910|NCT01856322|BG003|Baseline|Total|Total of all reporting groups
11362911|NCT01856322|FG000|Participant Flow|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
11362912|NCT01856322|FG001|Participant Flow|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
11362913|NCT01856322|FG002|Participant Flow|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
11362914|NCT01856322|OG000|Outcome|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
11362915|NCT01856322|OG001|Outcome|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
11362916|NCT01856322|EG000|Reported Event|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
11362917|NCT01856322|EG001|Reported Event|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
11362918|NCT01856322|EG002|Reported Event|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
11362919|NCT01853176|BG000|Baseline|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
11362920|NCT01853176|BG001|Baseline|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
11362921|NCT01853176|BG002|Baseline|Total|Total of all reporting groups
11362922|NCT01853176|FG000|Participant Flow|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
11362923|NCT01853176|FG001|Participant Flow|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
11362924|NCT01853176|OG000|Outcome|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
11362925|NCT01853176|OG001|Outcome|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
11362926|NCT01853176|EG000|Reported Event|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
11362927|NCT01853176|EG001|Reported Event|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
11362928|NCT01857271|BG000|Baseline|Treatment (Erlotinib Hydrochloride and Thoracotomy)|"Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.~Erlotinib Hydrochloride: Given PO~Therapeutic Conventional Surgery: Undergo thoracotomy~Laboratory Biomarker Analysis: Correlative studies"
11362929|NCT01857271|FG000|Participant Flow|Treatment (Erlotinib Hydrochloride)|"Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo restaging procedures to evaluate for surgery.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11362930|NCT01857271|OG000|Outcome|Treatment (Erlotinib Hydrochloride and Thoracotomy)|"Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.~Erlotinib Hydrochloride: Given PO~Therapeutic Conventional Surgery: Undergo thoracotomy~Laboratory Biomarker Analysis: Correlative studies"
11362931|NCT01857271|EG000|Reported Event|Treatment (Erlotinib Hydrochloride and Thoracotomy)|"Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.~Erlotinib Hydrochloride: Given PO~Therapeutic Conventional Surgery: Undergo thoracotomy~Laboratory Biomarker Analysis: Correlative studies"
11362932|NCT01856361|BG000|Baseline|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
11362933|NCT01856361|BG001|Baseline|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
11362934|NCT01856361|BG002|Baseline|Total|Total of all reporting groups
11362935|NCT01856361|FG000|Participant Flow|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
11362936|NCT01856361|FG001|Participant Flow|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
11362937|NCT01856361|OG000|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
11362938|NCT01856361|OG001|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
11362939|NCT01856361|EG000|Reported Event|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
11362940|NCT01856361|EG001|Reported Event|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
11362941|NCT01853982|BG000|Baseline|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
11362942|NCT01853982|BG001|Baseline|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
11362943|NCT01853982|BG002|Baseline|Total|Total of all reporting groups
11362944|NCT01853982|FG000|Participant Flow|Ceftolozane/Tazobactam|3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
11362945|NCT01853982|FG001|Participant Flow|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
11362946|NCT01853982|OG000|Outcome|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
11362947|NCT01853982|OG001|Outcome|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
11362948|NCT01853982|EG000|Reported Event|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
11362949|NCT01853982|EG001|Reported Event|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
11362950|NCT01841931|BG000|Baseline|Patient|Enrolled patients
11362951|NCT01841931|FG000|Participant Flow|Patient|Enrolled patients
11362952|NCT01841931|OG000|Outcome|Patient|Enrolled patients
11362953|NCT01841931|EG000|Reported Event|Patient|Enrolled patients
11362954|NCT01836809|BG000|Baseline|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to nesiritide"
11362955|NCT01836809|BG001|Baseline|Total Artificial Heart: Placebo|"Total Artificial Heart group~randomized to placebo"
11362956|NCT01836809|BG002|Baseline|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to nesiritide"
11362957|NCT01836809|BG003|Baseline|LVAD: Placebo|"Control arm of the LVAD group~randomized to placebo"
11362958|NCT01836809|BG004|Baseline|Total|Total of all reporting groups
11362959|NCT01836809|FG000|Participant Flow|Total Artificial Heart|"Active arm of Total Artificial Heart group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
11362960|NCT01836809|FG001|Participant Flow|Total Artificial Heart: Placebo|This arm included subject who received a total artificial heart and will be randomized receive placebo
11362961|NCT01836809|FG002|Participant Flow|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
11362962|NCT01836809|FG003|Participant Flow|LVAD: Placebo|This arm will consist of subjects who received an LVAD and will be randomized to placebo
11362963|NCT01836809|OG000|Outcome|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to receive nesiritide"
11362964|NCT01836809|OG001|Outcome|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group~randomized to receive placebo"
11362965|NCT01836809|OG002|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide"
11362966|NCT01836809|OG003|Outcome|LVAD: Placebo|"Active arm of the LVAD group~randomized to receive placebo"
11362967|NCT01836809|OG000|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
11362968|NCT01836809|OG001|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
11362969|NCT01836809|OG002|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
11362970|NCT01836809|OG003|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
11362971|NCT01836809|EG000|Reported Event|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to receive nesiritide 0.005 mcg/kg/min without bolus"
11362972|NCT01836809|EG001|Reported Event|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group~randomized to receive placebo"
11362973|NCT01836809|EG002|Reported Event|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
11362974|NCT01836809|EG003|Reported Event|LVAD: Placebo|"Control arm of the LVAD group~randomized to receive placebo"
11362975|NCT01831596|BG000|Baseline|ciSNaP|SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
11362976|NCT01831596|FG000|Participant Flow|ciSNaP|SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
11362977|NCT01831596|OG000|Outcome|ciSNaP|SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
11362978|NCT01831596|EG000|Reported Event|ciSNaP|SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
11362979|NCT01834144|BG000|Baseline|Moderate Intensity Exercise|"150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)~Exercise Training"
11362980|NCT01834144|BG001|Baseline|Moderate + Vigorous Intensity Exercise|"150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)~Exercise Training"
11362981|NCT01834144|BG002|Baseline|Total|Total of all reporting groups
11362982|NCT01834144|FG000|Participant Flow|Moderate Intensity Exercise|"150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)~Exercise Training"
11362983|NCT01834144|FG001|Participant Flow|Moderate + Vigorous Intensity Exercise|"150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)~Exercise Training"
11362984|NCT01834144|OG000|Outcome|Moderate Intensity Exercise|"150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)~Exercise Training"
11362985|NCT01834144|OG001|Outcome|Moderate + Vigorous Intensity Exercise|"150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)~Exercise Training"
11362986|NCT01834144|EG000|Reported Event|Moderate Intensity Exercise|"150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)~Exercise Training"
11362987|NCT01834144|EG001|Reported Event|Moderate + Vigorous Intensity Exercise|"150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)~Exercise Training"
11362988|NCT01821963|BG000|Baseline|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
11239945|NCT02474498|OG000|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239946|NCT02474498|OG001|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239947|NCT02474498|OG002|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
11239948|NCT02474498|EG000|Reported Event|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239949|NCT02474498|EG001|Reported Event|βTCP/HA + EMD|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239950|NCT02474498|EG002|Reported Event|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
11239951|NCT02474589|BG000|Baseline|Active|"600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~tecovirimat: Study is based on Animal Regulatory Rule"
11239952|NCT02474589|BG001|Baseline|Placebo|"matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~Placebo: Does not apply"
11239953|NCT02474589|BG002|Baseline|Total|Total of all reporting groups
11239954|NCT02474589|FG000|Participant Flow|Active|"600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~tecovirimat: Study is based on Animal Regulatory Rule"
11239955|NCT02474589|FG001|Participant Flow|Placebo|"matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~Placebo: Does not apply"
11239956|NCT02474589|OG000|Outcome|Active|"600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~tecovirimat: Study is based on Animal Regulatory Rule"
11239957|NCT02474589|OG001|Outcome|Placebo|"matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~Placebo: Does not apply"
11239958|NCT02474589|EG000|Reported Event|Active|"600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~tecovirimat: Study is based on Animal Regulatory Rule"
11239959|NCT02474589|EG001|Reported Event|Placebo|"matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~Placebo: Does not apply"
11362989|NCT01821963|FG000|Participant Flow|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
11362990|NCT01821963|OG000|Outcome|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
11362991|NCT01821963|EG000|Reported Event|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
11362992|NCT01821898|BG000|Baseline|Positive for Food Allergy: Group A|"Oral Budesonide~Oral Budesonide: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day."
11362993|NCT01821898|BG001|Baseline|Positive for Food Allergy: Group B|"Elimination diet~Elimination diet: This group will receive an elimination diet"
11362994|NCT01821898|BG002|Baseline|Total|Total of all reporting groups
11362995|NCT01821898|FG000|Participant Flow|Positive for Food Allergy: Group A|"Oral Budesonide~Oral Budesonide: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day. Children < 10 years will receive 1 mg daily. Children 10 years and older will receive 2 mg daily."
11362996|NCT01821898|FG001|Participant Flow|Positive for Food Allergy: Group B|"Elimination diet~Elimination diet: This group will receive an elimination diet"
11362997|NCT01821898|OG000|Outcome|Positive for Food Allergy: Group A|"Oral Budesonide~Oral Budesonide: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day. Children < 10 years will receive 1 mg daily. Children 10 years and older will receive 2 mg daily."
10962667|NCT00867815|OG000|Outcome|PDE5 Inhibitor Use & Risk of NAION|Participants were assessed at 2 visits. Visit 1 (Day 1) included screening, confirmation of the diagnosis of NAION, enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90+/-30) was a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION. No interventional treatment was administered in the context of this study.
11362998|NCT01821898|OG001|Outcome|Positive for Food Allergy: Group B|"Elimination diet~Elimination diet: This group will receive an elimination diet"
11362999|NCT01821898|OG000|Outcome|Positive for Food Allergy: Group A|"Oral Budesonide~Oral Budesonide: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day"
11363000|NCT01821898|EG000|Reported Event|Positive for Food Allergy: Group A|"Oral Budesonide~Oral Budesonide: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day. Children < 10 years will receive 1 mg daily. Children 10 years and older will receive 2 mg daily."
11363001|NCT01821898|EG001|Reported Event|Positive for Food Allergy: Group B|"Elimination diet~Elimination diet: This group will receive an elimination diet"
11363002|NCT01814722|BG000|Baseline|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
11363003|NCT01814722|BG001|Baseline|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
11363004|NCT01814722|BG002|Baseline|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
11363005|NCT01814722|BG003|Baseline|Total|Total of all reporting groups
11363006|NCT01814722|FG000|Participant Flow|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
11363007|NCT01814722|FG001|Participant Flow|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
11363008|NCT01814722|FG002|Participant Flow|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
11363009|NCT01814722|OG000|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
11363010|NCT01814722|OG001|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
11363011|NCT01814722|OG002|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
11363012|NCT01814722|EG000|Reported Event|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
11363013|NCT01814722|EG001|Reported Event|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
11363014|NCT01814722|EG002|Reported Event|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
11363015|NCT01830790|BG000|Baseline|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
11363016|NCT01830790|BG001|Baseline|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
11363017|NCT01830790|BG002|Baseline|Total|Total of all reporting groups
11363018|NCT01830790|FG000|Participant Flow|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
11363019|NCT01830790|FG001|Participant Flow|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
11363020|NCT01830790|OG000|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
11363021|NCT01830790|OG001|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
11363022|NCT01830790|EG000|Reported Event|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
11363023|NCT01830790|EG001|Reported Event|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
11363024|NCT01829477|BG000|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
11363025|NCT01829477|BG001|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
11363026|NCT01829477|BG002|Baseline|Total|Total of all reporting groups
11363027|NCT01829477|FG000|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
11363028|NCT01829477|FG001|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
11363029|NCT01829477|OG000|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
11363030|NCT01829477|OG001|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
11363031|NCT01829477|EG000|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
11363032|NCT01829477|EG001|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
11363033|NCT01803711|BG000|Baseline|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~Age range: 53 to 66 years Gender: 1 male and 1 female"
11363034|NCT01803711|BG001|Baseline|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement) Age range: 53 to 66 years ] Gender: 1 male and 2 females"
11363035|NCT01803711|BG002|Baseline|Total|Total of all reporting groups
11363036|NCT01803711|FG000|Participant Flow|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
11363037|NCT01803711|FG001|Participant Flow|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
11363038|NCT01803711|OG000|Outcome|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids"
11363039|NCT01803711|OG001|Outcome|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)"
11363040|NCT01803711|OG000|Outcome|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
11363041|NCT01803711|OG001|Outcome|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
11363042|NCT01803711|EG000|Reported Event|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
11363043|NCT01803711|EG001|Reported Event|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
11363044|NCT01821859|BG000|Baseline|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
11363045|NCT01821859|FG000|Participant Flow|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
11363046|NCT01821859|OG000|Outcome|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
11363047|NCT01821859|EG000|Reported Event|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
11363048|NCT01808950|BG000|Baseline|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
11363049|NCT01808950|BG001|Baseline|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
11363050|NCT01808950|BG002|Baseline|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
11363051|NCT01808950|BG003|Baseline|Total|Total of all reporting groups
11363052|NCT01808950|FG000|Participant Flow|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
11363053|NCT01808950|FG001|Participant Flow|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
11363054|NCT01808950|FG002|Participant Flow|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
11188780|NCT02115750|EG000|Reported Event|Enbrel-CHS-0214 (Etanercept)|"Enbrel 50mg weekly times 24 weeks and CHS-0214 for weeks 25 to 48.~Etanercept: Head-to-head comparison"
11188781|NCT02115750|EG001|Reported Event|CHS-0214-CHS-0214|"CHS-0214 50mg weekly times 48 weeks.~CHS-0214"
11363055|NCT01808950|OG000|Outcome|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
11363056|NCT01808950|OG001|Outcome|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
11363057|NCT01808950|OG002|Outcome|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
11363058|NCT01808950|OG000|Outcome|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
11363059|NCT01808950|OG001|Outcome|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
11363060|NCT01808950|OG002|Outcome|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C: shave biopsy of BCC followed by single 100mg dose"
11363061|NCT01808950|EG000|Reported Event|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
11363062|NCT01808950|EG001|Reported Event|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
11363063|NCT01808950|EG002|Reported Event|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
11363064|NCT01806051|BG000|Baseline|All Participants|
11363065|NCT01806051|FG000|Participant Flow|All Participants|Participants signed the consent forms and withdrew because they found the study procedures to be too cumbersome.
11188782|NCT02115815|BG000|Baseline|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
11188783|NCT02115815|BG001|Baseline|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
11188784|NCT02115815|BG002|Baseline|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188785|NCT02115815|BG003|Baseline|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
11188786|NCT02115815|BG004|Baseline|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188787|NCT02115815|BG005|Baseline|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
11188788|NCT02115815|BG006|Baseline|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188789|NCT02115815|BG007|Baseline|Total|Total of all reporting groups
11188790|NCT02115815|FG000|Participant Flow|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
11188791|NCT02115815|FG001|Participant Flow|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
11239960|NCT02474901|BG000|Baseline|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
11239961|NCT02474901|BG001|Baseline|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
11239962|NCT02474901|BG002|Baseline|Total|Total of all reporting groups
11239963|NCT02474901|FG000|Participant Flow|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
11239964|NCT02474901|FG001|Participant Flow|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
11239965|NCT02474901|OG000|Outcome|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
11188792|NCT02115815|FG002|Participant Flow|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188793|NCT02115815|FG003|Participant Flow|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
11188794|NCT02115815|FG004|Participant Flow|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188795|NCT02115815|FG005|Participant Flow|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
11188796|NCT02115815|FG006|Participant Flow|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188797|NCT02115815|OG000|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
11188798|NCT02115815|OG001|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
11188799|NCT02115815|OG002|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188800|NCT02115815|OG003|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
11188801|NCT02115815|OG004|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188802|NCT02115815|OG005|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
11188803|NCT02115815|OG006|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188804|NCT02115815|EG000|Reported Event|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
11188805|NCT02115815|EG001|Reported Event|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
11188806|NCT02115815|EG002|Reported Event|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188807|NCT02115815|EG003|Reported Event|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
11188808|NCT02115815|EG004|Reported Event|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188809|NCT02115815|EG005|Reported Event|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
11188810|NCT02115815|EG006|Reported Event|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
11188811|NCT02115828|BG000|Baseline|Vismodegib|"Vismodegib Treatment arm will receive Vismodegib by mouth 150 mg daily up to 1 year.~Vismodegib"
11188812|NCT02115828|FG000|Participant Flow|Vismodegib|"Vismodegib Treatment arm will receive Vismodegib by mouth 150 mg daily up to 1 year.~Vismodegib"
11188813|NCT02115828|OG000|Outcome|Vismodegib|"Vismodegib Treatment arm will receive Vismodegib by mouth 150 mg daily up to 1 year.~Vismodegib"
11188814|NCT02115828|EG000|Reported Event|Vismodegib|"Vismodegib Treatment arm will receive Vismodegib by mouth 150 mg daily up to 1 year.~Vismodegib"
11363066|NCT01806051|OG000|Outcome|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.~They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).~Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
11363067|NCT01806051|OG001|Outcome|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.~These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
11363068|NCT01806051|EG000|Reported Event|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.~They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).~Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
11363069|NCT01806051|EG001|Reported Event|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.~These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
11363070|NCT01808794|BG000|Baseline|Mucograft|"Placement of randomized membrane on half of subjects Mucograft~Mucograft: Mucograft Collagen Matrix"
11363071|NCT01808794|BG001|Baseline|Dynamatrix|"Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement~Dynamatrix: Dynamatrix"
11363072|NCT01808794|BG002|Baseline|Total|Total of all reporting groups
11363073|NCT01808794|FG000|Participant Flow|Mucograft|"Placement of randomized membrane on half of subjects Mucograft~Mucograft: Mucograft Collagen Matrix"
11363074|NCT01808794|FG001|Participant Flow|Dynamatrix|"Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement~Dynamatrix: Dynamatrix"
11363075|NCT01808794|OG000|Outcome|Mucograft|"Placement of randomized membrane on half of subjects Mucograft~Mucograft: Mucograft Collagen Matrix"
11363076|NCT01808794|OG001|Outcome|Dynamatrix|"Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement~Dynamatrix: Dynamatrix"
11363077|NCT01808794|EG000|Reported Event|Mucograft|"Placement of randomized membrane on half of subjects Mucograft~Mucograft: Mucograft Collagen Matrix"
11363078|NCT01808794|EG001|Reported Event|Dynamatrix|"Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement~Dynamatrix: Dynamatrix"
11363079|NCT01809899|BG000|Baseline|Enhanced Consent Procedure|"Participants in this group will receive an enhanced consent that will be an hour longer than usual.~Consent procedure: Enhanced consent entails a more detailed consent procedure than is routine."
11363080|NCT01809899|BG001|Baseline|Consent as Usual Procedure|Participants in this group will receive a normal consent procedure to the study
11363081|NCT01809899|BG002|Baseline|Total|Total of all reporting groups
11363082|NCT01809899|FG000|Participant Flow|Enhanced Consent Procedure|Enhanced consent includes use of teach back methods, video clips illustrating various study methods, and repeated confirmation of consent.
11363083|NCT01809899|FG001|Participant Flow|Consent as Usual|Consent as Usual, with no Enhanced Consent features
11363084|NCT01809899|OG000|Outcome|Enhanced Consent Procedure|Enhanced Consent Procedure involved enhanced Institutional Review Board (IRB) consent procedures.
11363085|NCT01809899|OG001|Outcome|Consent as Usual|Consent as Usual, involving no Enhanced Consent features
11363086|NCT01809899|OG000|Outcome|Enhanced Consent Procedure|Enhanced Consent Procedure involved enhanced IRB consent procedures.
11363087|NCT01809899|EG000|Reported Event|Enhanced Consent Procedure|"Participants in this group will receive an enhanced consent that will be an hour longer than usual.~Consent procedure: Enhanced consent entails a more detailed consent procedure"
11363088|NCT01809899|EG001|Reported Event|Consent as Usual Procedure|"Participants in this group will receive a normal consent procedure to the study~Consent procedure: Enhanced consent entails a more detailed consent procedure"
11363089|NCT01810302|BG000|Baseline|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
11363090|NCT01810302|BG001|Baseline|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
11363091|NCT01810302|BG002|Baseline|Total|Total of all reporting groups
11363092|NCT01810302|FG000|Participant Flow|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
11363093|NCT01810302|FG001|Participant Flow|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
11363094|NCT01810302|OG000|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
11363095|NCT01810302|OG001|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
11363096|NCT01810302|EG000|Reported Event|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
11363097|NCT01810302|EG001|Reported Event|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
11363098|NCT01806961|BG000|Baseline|Clearance at End of Trial SP848-AK-1101|no trial medication during this follow-up trial
11363099|NCT01806961|FG000|Participant Flow|SP848-AK-1101|Patients from SP848-AK-1101 trial
11363100|NCT01806961|OG000|Outcome|Group 1|Patients from SP848-AK-1101 trial
11363101|NCT01806961|EG000|Reported Event|Group 1|Patients from SP848-AK-1101 trial
11363102|NCT01804166|BG000|Baseline|IBD Patients With HSTCL|Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
11363103|NCT01804166|FG000|Participant Flow|IBD Patients With HSTCL|Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
11363104|NCT01804166|OG000|Outcome|IBD Patients With HSTCL|Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
11363105|NCT01804166|EG000|Reported Event|IBD Patients With HSTCL|Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
11363106|NCT01783015|BG000|Baseline|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
11363107|NCT01783015|BG001|Baseline|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
11363108|NCT01783015|BG002|Baseline|Total|Total of all reporting groups
11363109|NCT01783015|FG000|Participant Flow|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
11363110|NCT01783015|FG001|Participant Flow|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
11363111|NCT01783015|FG002|Participant Flow|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
11363112|NCT01783015|OG000|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
11363113|NCT01783015|OG001|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
11363114|NCT01783015|OG002|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
11363115|NCT01783015|EG000|Reported Event|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
11363116|NCT01783015|EG001|Reported Event|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
11363117|NCT01783015|EG002|Reported Event|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
11363118|NCT01800162|BG000|Baseline|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
11363119|NCT01800162|BG001|Baseline|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
11363120|NCT01800162|BG002|Baseline|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
11363121|NCT01800162|BG003|Baseline|Total|Total of all reporting groups
11363122|NCT01800162|FG000|Participant Flow|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
11363123|NCT01800162|FG001|Participant Flow|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
11363124|NCT01800162|FG002|Participant Flow|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
11363125|NCT01800162|OG000|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
11363126|NCT01800162|OG001|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
11363127|NCT01800162|OG000|Outcome|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
11363128|NCT01800162|OG001|Outcome|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
11363129|NCT01800162|EG000|Reported Event|Uterine Evacuation|No AE to Report
11363130|NCT01800162|EG001|Reported Event|Expectant Management|No AE to Report
11363131|NCT01794936|BG000|Baseline|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
11363132|NCT01794936|FG000|Participant Flow|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
11363133|NCT01794936|OG000|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
11363134|NCT01794936|EG000|Reported Event|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
11363135|NCT01797380|BG000|Baseline|Sugar Pill|Placebo
11363136|NCT01797380|BG001|Baseline|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
11363137|NCT01797380|BG002|Baseline|Total|Total of all reporting groups
11363138|NCT01797380|FG000|Participant Flow|Sugar Pill|Placebo
11363139|NCT01797380|FG001|Participant Flow|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
10962668|NCT00867815|EG000|Reported Event|PDE5 Inhibitor Use & Risk of NAION|Participants were assessed at 2 visits. Visit 1 (Day 1) included screening, confirmation of the diagnosis of NAION, enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90+/-30) was a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION. No interventional treatment was administered in the context of this study.
11363140|NCT01797380|OG000|Outcome|Sugar Pill|Placebo
11363141|NCT01797380|OG001|Outcome|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
11363142|NCT01797380|EG000|Reported Event|Sugar Pill|Placebo
11363143|NCT01797380|EG001|Reported Event|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
11363144|NCT01781026|BG000|Baseline|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
11363145|NCT01781026|FG000|Participant Flow|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
11363146|NCT01781026|OG000|Outcome|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
11363147|NCT01781026|EG000|Reported Event|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
11363148|NCT01788475|BG000|Baseline|Dexamethasone Implant up to Every 3 Mo.|"Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.~Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363149|NCT01788475|BG001|Baseline|Dexamethasone Implant up to Every 6 Mo.|"Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.~Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363150|NCT01788475|BG002|Baseline|Sham Implant|"Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2.~Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363151|NCT01788475|BG003|Baseline|Total|Total of all reporting groups
11363152|NCT01788475|FG000|Participant Flow|Dexamethasone Implant up to Every 3 Mo.|"Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.~Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363153|NCT01788475|FG001|Participant Flow|Dexamethasone Implant up to Every 6 Mo.|"Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.~Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363154|NCT01788475|FG002|Participant Flow|Sham Implant|"Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2.~Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363155|NCT01788475|OG000|Outcome|Dexamethasone Implant up to Every 3 Mo.|"Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.~Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363156|NCT01788475|OG001|Outcome|Dexamethasone Implant up to Every 6 Mo.|"Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.~Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363157|NCT01788475|OG002|Outcome|Sham Implant|"Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2.~Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363158|NCT01788475|EG000|Reported Event|Dexamethasone Implant up to Every 3 Mo.|"Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.~Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363159|NCT01788475|EG001|Reported Event|Dexamethasone Implant up to Every 6 Mo.|"Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.~Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363160|NCT01788475|EG002|Reported Event|Sham Implant|"Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter.~Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2.~Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met:~Increase of > 50 microns from the best previous CRT measurement~Recurrence of intraretinal cystic edema~Persistent intraretinal cystic edema~Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant"
11363161|NCT01784991|BG000|Baseline|1mg + 1mg Hydromorphone|"Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication. If yes, patients will immediately receive 1mg hydromorphone. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.~Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint."
11363162|NCT01784991|BG001|Baseline|Usual Care Group|"Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication. If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per usual care. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.~Usual care group: Patient will have pain treated at timepoint 0 as per usual care based on physician discretion. At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion."
11363163|NCT01784991|BG002|Baseline|Total|Total of all reporting groups
10962669|NCT00867932|BG000|Baseline|Eculizumab|Eculizumab was administered as an IV infusion for 12 weeks. All participants weighed more than 45 kg and received the following weight-based dosing regimen: induction/loading = 600 mg weekly x 4; maintenance = 900 mg at Wk 5; 900 mg Q2W.
11363164|NCT01784991|FG000|Participant Flow|1mg + 1mg Hydromorphone|"Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication. If yes, patients will immediately receive 1mg hydromorphone. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.~Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint."
11363165|NCT01784991|FG001|Participant Flow|Usual Care Group|"Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication. If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per usual care. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.~Usual care group: Patient will have pain treated at timepoint 0 as per usual care based on physician discretion. At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion."
11363166|NCT01784991|OG000|Outcome|1mg + 1mg Hydromorphone|"Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication. If yes, patients will immediately receive 1mg hydromorphone. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.~Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint."
11363167|NCT01784991|OG001|Outcome|Usual Care Group|"Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication. If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per usual care. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.~Usual care group: Patient will have pain treated at timepoint 0 as per usual care based on physician discretion. At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion."
11363168|NCT01784991|EG000|Reported Event|1mg + 1mg Hydromorphone|"Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication. If yes, patients will immediately receive 1mg hydromorphone. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.~Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint."
11363169|NCT01784991|EG001|Reported Event|Usual Care Group|"Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication. If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per usual care. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.~Usual care group: Patient will have pain treated at timepoint 0 as per usual care based on physician discretion. At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion."
11363170|NCT01777854|BG000|Baseline|Pre Treatment|the study was terminated before patients received the medication The study did not progress to the point where the patients were randomized into different arms.
11363171|NCT01777854|FG000|Participant Flow|Omeprazole|"Omeprazole (generic) will be used. Children >20 kg will be given 20 mg PO daily for 4 weeks prior to tonsillectomy. This is the normal standard pediatric dosing for reflux.~Omeprazole is authorized to treat reflux in children. The study focuses on laryngopharyngeal reflux that possibly contributes to post tonsillectomy pain.~Omeprazole: The principal investigator will be contacted and will work with the research pharmacist to obtain the omeprazole (20 mg PO daily for patients >20kg) and placebo. The placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look. The medication will be locked in the designated medication cabinet at each office. It will be prepackaged for a 28 day course. The patient will start the treatment 4 weeks prior to tonsillectomy and stop the day before surgery. The medication will be given to the patient once the consent and assent are signed. This will avoid an"
11363172|NCT01777854|FG001|Participant Flow|Sugar Pill|"The placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look.~Omeprazole: The principal investigator will be contacted and will work with the research pharmacist to obtain the omeprazole (20 mg PO daily for patients >20kg) and placebo. The placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look. The medication will be locked in the designated medication cabinet at each office. It will be prepackaged for a 28 day course. The patient will start the treatment 4 weeks prior to tonsillectomy and stop the day before surgery. The medication will be given to the patient once the consent and assent are signed. This will avoid an unnecessary office visit to improve patient compliance."
11363173|NCT01777854|OG000|Outcome|Pre Treatment|
11363174|NCT01777854|EG000|Reported Event|Pre Treatment|This data was not collected
11363175|NCT01760993|BG000|Baseline|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
11363176|NCT01760993|FG000|Participant Flow|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
11363177|NCT01760993|OG000|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
11363178|NCT01760993|EG000|Reported Event|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
10962670|NCT00867932|FG000|Participant Flow|Eculizumab|Eculizumab was administered as an intravenous (IV) infusion for 12 weeks. All participants weighed more than 45 kilograms (kg) and received the following weight-based dosing regimen: induction/loading = 600 milligram (mg) weekly x 4; maintenance = 900 mg at Week (Wk) 5; 900 mg every 2 weeks (Q2W).
11363179|NCT01772719|BG000|Baseline|Study Arm|"Study Arm~Simvastatin and zoledronic acid: 1. Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.~2. Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly."
11363180|NCT01772719|FG000|Participant Flow|Simvastatin and Zoledronic Acid|"Simvastatin and zoledronic acid:~Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.~Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly."
11363181|NCT01772719|OG000|Outcome|Simvastatin and Zolendronic Acid|"Simvastatin and zoledronic acid:~Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.~Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly."
11363182|NCT01772719|OG000|Outcome|Simvastatin and Zoledronic Acid|"Simvastatin and zoledronic acid:~Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.~Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly."
11363183|NCT01772719|OG000|Outcome|Simvastatin and Zoledronic Acid|"Simvastatin and zoledronic acid: 1. Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.~2. Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly."
11363184|NCT01772719|OG000|Outcome|Study Arm|"Study Arm~Simvastatin and zoledronic acid: 1. Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.~2. Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly."
11363185|NCT01772719|EG000|Reported Event|Study Arm|"Study Arm~Simvastatin and zoledronic acid: 1. Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.~2. Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly."
11363186|NCT01764997|BG000|Baseline|Adalimumab Open Label run-in Treatment Only|Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX during run-in period. Participants who were not randomized in the main study or did not enter the sub-study were included in this arm for safety assessment.
11188815|NCT02115984|BG000|Baseline|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
11363187|NCT01764997|BG001|Baseline|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
11363188|NCT01764997|BG002|Baseline|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
11363189|NCT01764997|BG003|Baseline|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
11363190|NCT01764997|BG004|Baseline|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
11363191|NCT01764997|BG005|Baseline|Total|Total of all reporting groups
11363192|NCT01764997|FG000|Participant Flow|Adalimumab Open Label run-in|Adalimumab 40 mg subcutaneous (SC) injection every 2 weeks (Q2W) for 16 weeks added to stable dose of methotrexate (MTX).
11363193|NCT01764997|FG001|Participant Flow|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
11363194|NCT01764997|FG002|Participant Flow|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
11363195|NCT01764997|FG003|Participant Flow|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
11363196|NCT01764997|FG004|Participant Flow|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
11363197|NCT01764997|OG000|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
11363198|NCT01764997|OG001|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
11363199|NCT01764997|OG002|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
11363200|NCT01764997|EG000|Reported Event|Adalimumab Open Label run-in|Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX. AEs in this group were those collected from signature of the informed consent form up to the end of Adalimumab treatment (Week 16).
11363201|NCT01764997|EG001|Reported Event|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
11363202|NCT01764997|EG002|Reported Event|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
11363203|NCT01764997|EG003|Reported Event|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
11363204|NCT01764997|EG004|Reported Event|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX. AEs in this group were those collected from enrollment in the sub-study up to the final visit (Week 58).
11363205|NCT01760941|BG000|Baseline|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
11239966|NCT02474901|OG001|Outcome|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
11239967|NCT02474901|EG000|Reported Event|QLAIV, HIV-infected|Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-infected individuals 2 to 25 yoa
11239968|NCT02474901|EG001|Reported Event|QLAIV, HIV-uninfected|Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-uninfected individuals 2 to 25 yoa
11239969|NCT02475031|BG000|Baseline|Placebo Group (TAP-S)|"(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
11239970|NCT02475031|BG001|Baseline|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
11239971|NCT02475031|BG002|Baseline|Total|Total of all reporting groups
11239972|NCT02475031|FG000|Participant Flow|Placebo Group (TAP-S)|"(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
11239973|NCT02475031|FG001|Participant Flow|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
11239974|NCT02475031|OG000|Outcome|Placebo Group (TAP-S)|"(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
11239975|NCT02475031|OG001|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
11239976|NCT02475031|OG000|Outcome|Placebo Group (TAP-S)|"(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP-S: Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case."
11239977|NCT02475031|OG001|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP-C: TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case."
11239978|NCT02475031|EG000|Reported Event|Placebo Group (TAP-S)|"(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
11239979|NCT02475031|EG001|Reported Event|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
11239980|NCT02475070|BG000|Baseline|Vildagliptin First|"Treatment with vildagliptin 50mg twice daily for two weeks followed by four weeks washout and then treatment with dapagliflozin 10mg once daily for two weeks~Vildagliptin: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks~Dapagliflozin: Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks"
11363206|NCT01760941|FG000|Participant Flow|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
11363207|NCT01760941|OG000|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
11363208|NCT01760941|EG000|Reported Event|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
11363209|NCT01769443|BG000|Baseline|No Desensitization|No desensitization therapy pre-transplantation
11363210|NCT01769443|BG001|Baseline|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
11363211|NCT01769443|BG002|Baseline|Total|Total of all reporting groups
11363212|NCT01769443|FG000|Participant Flow|No Desensitization|No desensitization therapy pre-transplantation
11363213|NCT01769443|FG001|Participant Flow|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
11363214|NCT01769443|OG000|Outcome|No Desensitization|No desensitization therapy pre-transplantation
11363215|NCT01769443|OG001|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
11363216|NCT01769443|OG001|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
11363217|NCT01769443|EG000|Reported Event|No Desensitization|No desensitization therapy pre-transplantation
11363218|NCT01769443|EG001|Reported Event|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
11363219|NCT01760889|BG000|Baseline|SPD489 Low Dose Range|SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks
11363220|NCT01760889|BG001|Baseline|SPD489 High Dose Range|SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
11363221|NCT01760889|BG002|Baseline|Placebo|Placebo: One capsule a day for 26 weeks
11363222|NCT01760889|BG003|Baseline|Total|Total of all reporting groups
11239981|NCT02475070|BG001|Baseline|Dapagliflozin First|"Treatment with dapagliflozin 10 mg once daily for two weeks followed by four weeks washout and then treatment with vildagliptin 50 mg twice daily for two weeks~Vildagliptin: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks~Dapagliflozin: Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks"
11239982|NCT02475070|BG002|Baseline|Total|Total of all reporting groups
11239983|NCT02475070|FG000|Participant Flow|Vildagliptin First|First intervention vildagliptin 50mg twice daily (2 weeks), Washout (4 weeks), Second intervention dapagliflozin 10mg once daily (2 weeks)
11239984|NCT02475070|FG001|Participant Flow|Dapagliflozin First|First intervention dapagliflozin 10mg once Daily (2 weeks), washout (4 weeks), second intervention with vildaglipitn 50mg twice Daily (2 weeks)
11239985|NCT02475070|OG000|Outcome|Vildagliptin Treatment|Vildagliptin 50mg twice daily for 2 weeks
11239986|NCT02475070|OG001|Outcome|Dapagliflozin Treatment|Dapagliflozin 10mg once Daily for 2 weeks
11239987|NCT02475070|OG001|Outcome|Dapagliflozin Treatment|Dapagliflozin 10mg once daily for 2 weeks
11239988|NCT02475070|EG000|Reported Event|Vildagliptin|Treatment with vildagliptin 50mg twice daily for two weeks
11239989|NCT02475070|EG001|Reported Event|Dapagliflozin|Treatment with dapagliflozin 10 mg once daily for two weeks
11239990|NCT02475265|BG000|Baseline|Estradiol 0.045mg/Levonorgestrel 0.015mg|"6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch).~estradiol 0.045 mg/levonorgestrel 0.015mg"
11239991|NCT02475265|FG000|Participant Flow|Estradiol 0.045mg/Levonorgestrel 0.015mg|"6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch).~estradiol 0.045 mg/levonorgestrel 0.015mg"
11239992|NCT02475265|OG000|Outcome|Estradiol 0.045mg/Levonorgestrel 0.015mg|"6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch).~estradiol 0.045 mg/levonorgestrel 0.015mg"
11239993|NCT02475265|EG000|Reported Event|Estradiol 0.045mg/Levonorgestrel 0.015mg|"6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch).~estradiol 0.045 mg/levonorgestrel 0.015mg"
11239994|NCT02475278|BG000|Baseline|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
11239995|NCT02475278|FG000|Participant Flow|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
11239996|NCT02475278|OG000|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
11239997|NCT02475278|EG000|Reported Event|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
11239998|NCT02475369|BG000|Baseline|All Study Treatments|"The treatment phase was comprised of two 10-day treatment periods. The study began with a 7 day washout period followed by Treatment period 1. After 10 day treatment period one all participants received a 7 day washout run-in period. Finally, all patients received a 10 day treatment period 2. Participants were randomized to two groups which were PES, then Placebo (n=3) or Placebo, then PES (n=9). Per cross-over design, all subjects have received both intervention at the end of the trial."
11239999|NCT02475369|FG000|Participant Flow|PES, Then Placebo|Participants first received Pancreatic Enzyme Supplementation (PES) for 10 days. PES taken 6 times daily with gluten free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received placebo tablets (matching PES treatment) 6 times daily for 10 days.
11240000|NCT02475369|FG001|Participant Flow|Placebo, Then PES|Participants first received placebo tablets (matching PES) for 10 days. Placebo was taken 6 times daily with gluten-free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received PES tablets six times daily for 10 days.
11240001|NCT02475369|OG000|Outcome|Placebo Treatment|Participants ingested placebo tablets 6 times daily (with meals and 3 snacks) for 10 days. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered
11240002|NCT02475369|OG001|Outcome|PES Treatment|PES treatment was taken 6 times daily with gluten-free meals and 3 snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered.
11240003|NCT02475369|OG002|Outcome|Within Participant Difference in Scores Between Treatment Periods|We calculated a delta change between the GSRS scores at end of Placebo treatment and end of PES treatment
11240004|NCT02475369|OG000|Outcome|Total Participants|Correlation between Baseline fecal elastase measurement and Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores at the end of PES treatment period.
11240005|NCT02475369|OG000|Outcome|Placebo Treatment|Evaluated CSI score across all participants during the Placebo treatment
11240006|NCT02475369|OG001|Outcome|PES Treatment|Evaluated CSI score across all participants during the PES treatment
11240007|NCT02475369|OG002|Outcome|Within Participant Difference in Scores Between Treatment Periods|We calculated a delta change between the CSI scores at the end of Placebo treatment and end of PES treatment.
11240008|NCT02475369|EG000|Reported Event|Placebo Treatment|Participants ingested placebo tablets 6 times daily (with meals and 3 snacks) for 10 days. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered.
11240009|NCT02475369|EG001|Reported Event|PES Treatment|Participants ingested PES tablets 6 times daily (with meals and 3 snacks) for 10 days. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered.
11240010|NCT02475395|BG000|Baseline|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
11240011|NCT02475395|BG001|Baseline|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
11240012|NCT02475395|BG002|Baseline|Total|Total of all reporting groups
11188816|NCT02115984|BG001|Baseline|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
11188817|NCT02115984|BG002|Baseline|Total|Total of all reporting groups
11188818|NCT02115984|FG000|Participant Flow|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
11188819|NCT02115984|FG001|Participant Flow|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
11188820|NCT02115984|OG000|Outcome|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
11188821|NCT02115984|OG001|Outcome|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
11188822|NCT02115984|EG000|Reported Event|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
11188823|NCT02115984|EG001|Reported Event|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
11188824|NCT02116205|BG000|Baseline|Vaccine + Placebo at 1.0 mg|"1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~Placebo: 0.9% sodium chloride~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188825|NCT02116205|BG001|Baseline|Vaccine at 1.0 mg|"1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188826|NCT02116205|BG002|Baseline|Vaccine + Placebo at 2.0 mg|"2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~Placebo: 0.9% sodium chloride~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188827|NCT02116205|BG003|Baseline|Vaccine at 2.0 mg|"2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188828|NCT02116205|BG004|Baseline|Total|Total of all reporting groups
10962671|NCT00867932|OG000|Outcome|Eculizumab|Eculizumab was administered as an IV infusion for 12 weeks. All participants weighed more than 45 kg and received the following weight-based dosing regimen: induction/loading = 600 mg weekly x 4; maintenance = 900 mg at Wk 5; 900 mg Q2W.
11240013|NCT02475395|FG000|Participant Flow|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
11240014|NCT02475395|FG001|Participant Flow|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
11240015|NCT02475395|OG000|Outcome|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
11240016|NCT02475395|OG001|Outcome|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
11240017|NCT02475395|EG000|Reported Event|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
11240018|NCT02475395|EG001|Reported Event|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
11240019|NCT02475564|BG000|Baseline|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
11240020|NCT02475564|BG001|Baseline|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
11240021|NCT02475564|BG002|Baseline|Total|Total of all reporting groups
11240022|NCT02475564|FG000|Participant Flow|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
11240023|NCT02475564|FG001|Participant Flow|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
11240024|NCT02475564|OG000|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
11240025|NCT02475564|OG001|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
11240026|NCT02475564|EG000|Reported Event|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
11240027|NCT02475564|EG001|Reported Event|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
11240028|NCT02475629|BG000|Baseline|Open-Label Ibalizumab Plus OBR|"2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.~ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks~Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive."
11240029|NCT02475629|FG000|Participant Flow|Open-Label Ibalizumab Plus OBR|"2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.~ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks~Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive."
11240030|NCT02475629|OG000|Outcome|Open-Label Ibalizumab Plus OBR|"2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.~ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks~Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive."
11240031|NCT02475629|EG000|Reported Event|Open-Label Ibalizumab Plus OBR|"2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.~ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks~Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive."
11240032|NCT02475655|BG000|Baseline|Arm A: Ruxolitinib|"Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.~Ruxolitinib: 10 mg orally twice daily for 5 weeks"
11240033|NCT02475655|BG001|Baseline|Arm B: No Study Treatment|Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.
11240034|NCT02475655|BG002|Baseline|Total|Total of all reporting groups
11240035|NCT02475655|FG000|Participant Flow|Arm A: Ruxolitinib|"Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.~Ruxolitinib: 10 mg orally twice daily for 5 weeks"
11363223|NCT01760889|FG000|Participant Flow|SPD489 Low Dose Range|SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks
11363224|NCT01760889|FG001|Participant Flow|SPD489 High Dose Range|SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
11363225|NCT01760889|FG002|Participant Flow|Placebo|Placebo: One capsule a day for 26 weeks
11363226|NCT01760889|OG000|Outcome|SPD489 Low Dose Range|SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks
11363227|NCT01760889|OG001|Outcome|SPD489 High Dose Range|SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
11363228|NCT01760889|OG002|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
11363229|NCT01760889|EG000|Reported Event|SPD489 Low Dose Range|SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks
11363230|NCT01760889|EG001|Reported Event|SPD489 High Dose Range|SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
11363231|NCT01760889|EG002|Reported Event|Placebo|Placebo: One capsule a day for 26 weeks
11363232|NCT01749826|BG000|Baseline|Chronic Opioid Exposure|Morphine Sulfate: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
11363233|NCT01749826|BG001|Baseline|Acute Opioid Exposure|Morphine Sulfate: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
11363234|NCT01749826|BG002|Baseline|Total|Total of all reporting groups
11363235|NCT01749826|FG000|Participant Flow|Chronic Opioid Exposure|Morphine Sulfate: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
11363236|NCT01749826|FG001|Participant Flow|Acute Opioid Exposure|Morphine Sulfate: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
10962672|NCT00867932|EG000|Reported Event|Eculizumab|Eculizumab was administered as an IV infusion for 12 weeks. All participants weighed more than 45 kg and received the following weight-based dosing regimen: induction/loading = 600 mg weekly x 4; maintenance = 900 mg at Wk 5; 900 mg Q2W.
11363237|NCT01749826|OG000|Outcome|Chronic Opioid Exposure|Morphine Sulfate: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
11363238|NCT01749826|OG001|Outcome|Acute Opioid Exposure|Morphine Sulfate: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
11363239|NCT01749826|EG000|Reported Event|Chronic Opioid Exposure|Morphine Sulfate: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
11363240|NCT01749826|EG001|Reported Event|Acute Opioid Exposure|Morphine Sulfate: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
11363241|NCT01756586|BG000|Baseline|Control|"Plain bupivacaine~Bupivacaine: Control"
11363242|NCT01756586|BG001|Baseline|Experimental|"Bupivacaine with Dexamethasone~Dexamethasone~Bupivacaine: Control"
11363243|NCT01756586|BG002|Baseline|Total|Total of all reporting groups
11363244|NCT01756586|FG000|Participant Flow|Control|"Plain bupivacaine~Bupivacaine: Control"
11363245|NCT01756586|FG001|Participant Flow|Experimental|"Bupivacaine with Dexamethasone~Dexamethasone~Bupivacaine: Control"
11363246|NCT01756586|OG000|Outcome|Control|"Plain bupivacaine~Bupivacaine: Control"
11363247|NCT01756586|OG001|Outcome|Experimental|"Bupivacaine with Dexamethasone~Dexamethasone~Bupivacaine: Control"
11363248|NCT01756586|EG000|Reported Event|Control|"Plain bupivacaine~Bupivacaine: Control"
11363249|NCT01756586|EG001|Reported Event|Experimental|"Bupivacaine with Dexamethasone~Dexamethasone~Bupivacaine: Control"
11363250|NCT01754987|BG000|Baseline|Ascorbic Acid + Sorafenib|"Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate~Dosage:~Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)~Ascorbic Acid + Sorafenib"
11363251|NCT01754987|BG001|Baseline|Sorafenib Alone|"Sorafenib: taken daily (oral)~Sorafenib"
11363252|NCT01754987|BG002|Baseline|Total|Total of all reporting groups
11363253|NCT01754987|FG000|Participant Flow|Ascorbic Acid + Sorafenib|"Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate~Dosage:~Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)~Ascorbic Acid + Sorafenib"
11363254|NCT01754987|FG001|Participant Flow|Sorafenib Alone|"Sorafenib: taken daily (oral)~Sorafenib"
11363255|NCT01754987|OG000|Outcome|Ascorbic Acid + Sorafenib|"Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate~Dosage:~Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)~Ascorbic Acid + Sorafenib"
11363256|NCT01754987|OG001|Outcome|Sorafenib Alone|"Sorafenib: taken daily (oral)~Sorafenib"
11363257|NCT01754987|EG000|Reported Event|Ascorbic Acid + Sorafenib|"Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate~Dosage:~Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)~Ascorbic Acid + Sorafenib"
11363258|NCT01754987|EG001|Reported Event|Sorafenib Alone|"Sorafenib: taken daily (oral)~Sorafenib"
11363259|NCT01756560|BG000|Baseline|Control|"in this group, plain bupivacaine will be used to block femoral and sciatic nerve~Bupivacaine"
11363260|NCT01756560|BG001|Baseline|Dexamethasone|"Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve~dexamethsone~Bupivacaine"
11363261|NCT01756560|BG002|Baseline|Total|Total of all reporting groups
11363262|NCT01756560|FG000|Participant Flow|Control|"in this group, plain bupivacaine will be used to block femoral and sciatic nerve~Bupivacaine"
11363263|NCT01756560|FG001|Participant Flow|Dexamethasone|"Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve~dexamethsone~Bupivacaine"
11363264|NCT01756560|OG000|Outcome|Control|"in this group, plain bupivacaine will be used to block femoral and sciatic nerve~Bupivacaine"
11363265|NCT01756560|OG001|Outcome|Dexamethasone|"Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve~dexamethsone~Bupivacaine"
11363266|NCT01756560|EG000|Reported Event|Control|"in this group, plain bupivacaine will be used to block femoral and sciatic nerve~Bupivacaine"
11363267|NCT01756560|EG001|Reported Event|Dexamethasone|"Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve~dexamethsone~Bupivacaine"
11363268|NCT01756573|BG000|Baseline|Bupivacaine|"Control~Bupivacaine"
11363269|NCT01756573|BG001|Baseline|Bupivacaine With Dexamethasone|"Dexamethasone will be mixed with bupivacaine~Dexamthsone~Bupivacaine"
11363270|NCT01756573|BG002|Baseline|Intravenous Dexamethasone|"Dexamethasone will be given intravenously~Dexamthsone~Bupivacaine"
11363271|NCT01756573|BG003|Baseline|Total|Total of all reporting groups
11363272|NCT01756573|FG000|Participant Flow|Bupivacaine|"Control~Bupivacaine"
11363273|NCT01756573|FG001|Participant Flow|Bupivacaine With Dexamethasone|"Dexamethasone will be mixed with bupivacaine~Dexamthsone~Bupivacaine"
11363274|NCT01756573|FG002|Participant Flow|Intravenous Dexamethasone|"Dexamethasone will be given intravenously~Dexamthsone~Bupivacaine"
11363275|NCT01756573|OG000|Outcome|Bupivacaine|"Control~Bupivacaine"
11363276|NCT01756573|OG001|Outcome|Bupivacaine With Dexamethasone|"Dexamethasone will be mixed with bupivacaine~Dexamthsone~Bupivacaine"
11363277|NCT01756573|OG002|Outcome|Intravenous Dexamethasone|"Dexamethasone will be given intravenously~Dexamthsone~Bupivacaine"
11363278|NCT01756573|EG000|Reported Event|Bupivacaine|"Control~Bupivacaine"
11363279|NCT01756573|EG001|Reported Event|Bupivacaine With Dexamethasone|"Dexamethasone will be mixed with bupivacaine~Dexamthsone~Bupivacaine"
11363280|NCT01756573|EG002|Reported Event|Intravenous Dexamethasone|"Dexamethasone will be given intravenously~Dexamthsone~Bupivacaine"
11363281|NCT01745913|BG000|Baseline|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1.
10962673|NCT00868101|BG000|Baseline|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
10962674|NCT00868101|BG001|Baseline|Control|Children who did not receive the preconditioning stimulus
10962675|NCT00868101|BG002|Baseline|Total|Total of all reporting groups
10962676|NCT00868101|FG000|Participant Flow|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
10962677|NCT00868101|FG001|Participant Flow|Control|Children who did not receive the preconditioning stimulus
10962678|NCT00868101|OG000|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
10962679|NCT00868101|OG001|Outcome|Control|Children who did not receive the preconditioning stimulus
10962680|NCT00868101|OG000|Outcome|Preconditioning|Children who received the preconditioning stimulus
10962681|NCT00868101|OG001|Outcome|Control|Children that don´t received the preconditioning stimmulus
10962682|NCT00868101|EG000|Reported Event|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
10962683|NCT00868101|EG001|Reported Event|Control|Children who did not receive the preconditioning stimulus
10962684|NCT00868140|BG000|Baseline|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
10962685|NCT00868140|BG001|Baseline|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
10962686|NCT00868140|BG002|Baseline|Total|Total of all reporting groups
10962687|NCT00868140|FG000|Participant Flow|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
10962688|NCT00868140|FG001|Participant Flow|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
10962689|NCT00868140|OG000|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
10962690|NCT00868140|OG001|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
10962691|NCT00868140|OG000|Outcome|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
10962692|NCT00868140|OG001|Outcome|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
10962693|NCT00868140|EG000|Reported Event|1/Pioglitazone|"Pioglitazone in pill form at 45mg twice per day for 6 months~pioglitazone: pioglitazone 45 mg"
11363282|NCT01745913|BG001|Baseline|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1.
11363283|NCT01745913|BG002|Baseline|Total|Total of all reporting groups
11363284|NCT01745913|FG000|Participant Flow|Haplo-Cord SCT|"The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1~CliniMACS® CD34 Reagent System: If a subject is randomized to the haplo-cord transplant group, their family member will undergo a stem cell collection. The stem cells from the haplo-identical donor will be purified by a procedure called CD34 selection before they are given to the subject. A special device called the CliniMACS® CD34 Reagent System, which is not FDA approved, will be used for this purpose."
11188829|NCT02116205|FG000|Participant Flow|Vaccine + Placebo at 1.0 mg|"1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~Placebo: 0.9% sodium chloride~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
10962694|NCT00868140|EG001|Reported Event|2/Placebo|"Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months~Placebo: placebo daily"
10962695|NCT00868166|BG000|Baseline|Olesoxime|"2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.~Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.~Riluzole: Riluzole given as add-on therapy 50mg bid."
10962696|NCT00868166|BG001|Baseline|Placebo Comparator|2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
10962697|NCT00868166|BG002|Baseline|Total|Total of all reporting groups
10962698|NCT00868166|FG000|Participant Flow|Olesoxime|"2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.~Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.~Riluzole: Riluzole given as add-on therapy 50mg bid."
10962699|NCT00868166|FG001|Participant Flow|Placebo Comparator|2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
10962700|NCT00868166|OG000|Outcome|Olesoxime|"2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.~Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.~Riluzole: Riluzole given as add-on therapy 50mg bid."
10962701|NCT00868166|OG001|Outcome|Placebo Comparator|2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
10962702|NCT00868166|EG000|Reported Event|Olesoxime|"2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.~Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.~Riluzole: Riluzole given as add-on therapy 50mg bid."
10962703|NCT00868166|EG001|Reported Event|Placebo Comparator|2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
10962704|NCT00868192|BG000|Baseline|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
10962705|NCT00868192|FG000|Participant Flow|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
10962706|NCT00868192|OG000|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
10962707|NCT00868192|EG000|Reported Event|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
10962708|NCT00868218|BG000|Baseline|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11363285|NCT01745913|FG001|Participant Flow|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1 Fludarabine: Fludarabine: 30 mg/m2 /day intravenously x 5 days total dose 150 mg/m2. Fludarabine will be dosed according to actual body weight Melphalan: Melphalan: 70mg/m2/day intravenously x 2 days. Melphalan will be dosed according to actual body weight.
11363286|NCT01745913|OG000|Outcome|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1.
11363287|NCT01745913|OG001|Outcome|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1.
11363288|NCT01745913|OG000|Outcome|Haplo-Cord SCT|"The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1~CliniMACS® CD34 Reagent System: If a subject is randomized to the haplo-cord transplant group, their family member will undergo a stem cell collection. The stem cells from the haplo-identical donor will be purified by a procedure called CD34 selection before they are given to the subject. A special device called the CliniMACS® CD34 Reagent System, which is not FDA approved, will be used for this purpose. The manufacturer of the device, Miltenyi Biotec, is providing the researchers access to the device for"
11363289|NCT01745913|OG001|Outcome|UCB SCT|"For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1~Fludarabine: Fludarabine: 30 mg/m2 /day intravenously x 5 days total dose 150 mg/m2. Fludarabine will be dosed according to actual body weight~Melphalan: Melphalan: 70mg/m2/day intravenously x 2 days. Melphalan will be dosed according to actual body weight. Cryotherapy with ice chips will be administered to prevent mucosit"
11363290|NCT01745913|OG000|Outcome|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1
11363291|NCT01745913|OG001|Outcome|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1
11363292|NCT01745913|EG000|Reported Event|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1.
11363293|NCT01745913|EG001|Reported Event|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1.
11363294|NCT01752023|BG000|Baseline|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
11363295|NCT01752023|BG001|Baseline|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
11363296|NCT01752023|BG002|Baseline|Total|Total of all reporting groups
11363297|NCT01752023|FG000|Participant Flow|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
11363298|NCT01752023|FG001|Participant Flow|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
11363299|NCT01752023|OG000|Outcome|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
11363300|NCT01752023|OG001|Outcome|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
11363301|NCT01752023|OG000|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
11363302|NCT01752023|OG001|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
11363303|NCT01752023|OG000|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Cisplatin + Gemcitabine with SUBATM-itraconazole: Experimental Arm"
11363304|NCT01752023|OG001|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Cisplatin + Gemcitabine: Active Comparator"
11363305|NCT01752023|EG000|Reported Event|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
11363306|NCT01752023|EG001|Reported Event|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
10962709|NCT00868218|BG001|Baseline|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11363307|NCT01740154|BG000|Baseline|Supportive Care (Sunitinib Malate, Neuromuscular Testing)|"Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.~transcranial magnetic stimulation: Undergo TMS~electromyography: Undergo EMG~survey administration: Ancillary studies~sunitinib malate: Given PO"
11363308|NCT01740154|FG000|Participant Flow|Supportive Care (Sunitinib Malate, Neuromuscular Testing)|"Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.~transcranial magnetic stimulation: Undergo TMS~electromyography: Undergo EMG~survey administration: Ancillary studies~sunitinib malate: Given PO"
11363309|NCT01740154|OG000|Outcome|Supportive Care (Sunitinib Malate, Neuromuscular Testing)|"Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.~transcranial magnetic stimulation: Undergo TMS~electromyography: Undergo EMG~survey administration: Ancillary studies~sunitinib malate: Given PO"
11363310|NCT01740154|EG000|Reported Event|Supportive Care (Sunitinib Malate, Neuromuscular Testing)|"Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.~transcranial magnetic stimulation: Undergo TMS~electromyography: Undergo EMG~survey administration: Ancillary studies~sunitinib malate: Given PO"
11363311|NCT01748890|BG000|Baseline|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
11363312|NCT01748890|FG000|Participant Flow|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
11363313|NCT01748890|OG000|Outcome|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
11363314|NCT01748890|EG000|Reported Event|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
11363315|NCT01748162|BG000|Baseline|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
11363316|NCT01748162|BG001|Baseline|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
11363317|NCT01748162|BG002|Baseline|Total|Total of all reporting groups
11363318|NCT01748162|FG000|Participant Flow|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
11363319|NCT01748162|FG001|Participant Flow|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
11363320|NCT01748162|OG000|Outcome|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
11363321|NCT01748162|OG001|Outcome|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
11363322|NCT01748162|EG000|Reported Event|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
11363323|NCT01748162|EG001|Reported Event|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
11363324|NCT01738698|BG000|Baseline|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
11363325|NCT01738698|BG001|Baseline|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
11363326|NCT01738698|BG002|Baseline|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
11363327|NCT01738698|BG003|Baseline|Placebo|Placebo: Oral administration once-daily for 12 weeks
11363328|NCT01738698|BG004|Baseline|Total|Total of all reporting groups
11363329|NCT01738698|FG000|Participant Flow|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
11363330|NCT01738698|FG001|Participant Flow|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
11363331|NCT01738698|FG002|Participant Flow|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
11363332|NCT01738698|FG003|Participant Flow|Placebo|Placebo: Oral administration once-daily for 12 weeks
11363333|NCT01738698|OG000|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
11363334|NCT01738698|OG001|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
11363335|NCT01738698|OG002|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
11363336|NCT01738698|OG003|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
11363337|NCT01738698|EG000|Reported Event|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
11363338|NCT01738698|EG001|Reported Event|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
11363339|NCT01738698|EG002|Reported Event|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
11363340|NCT01738698|EG003|Reported Event|Placebo|Placebo: Oral administration once-daily for 12 weeks
11363341|NCT01732926|BG000|Baseline|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
11363342|NCT01732926|BG001|Baseline|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
11363343|NCT01732926|BG002|Baseline|Total|Total of all reporting groups
11363344|NCT01732926|FG000|Participant Flow|Idelalisib + Bendamustine + Rituximab|"Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions)~+ rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)"
11363345|NCT01732926|FG001|Participant Flow|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
11363346|NCT01732926|OG000|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
11363347|NCT01732926|OG001|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
11363348|NCT01732926|EG000|Reported Event|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
11363349|NCT01732926|EG001|Reported Event|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
11363350|NCT01727167|BG000|Baseline|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
11363351|NCT01727167|BG001|Baseline|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
11363352|NCT01727167|BG002|Baseline|Total|Total of all reporting groups
11363353|NCT01727167|FG000|Participant Flow|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
11363354|NCT01727167|FG001|Participant Flow|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
10962710|NCT00868218|BG002|Baseline|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11363355|NCT01727167|OG000|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
11363356|NCT01727167|OG001|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
11240036|NCT02475655|FG001|Participant Flow|Arm B: No Study Treatment|Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.
11240037|NCT02475655|OG000|Outcome|Arm A: Ruxolitinib|"Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.~Ruxolitinib: 10 mg orally twice daily for 5 weeks"
11240038|NCT02475655|OG001|Outcome|Arm B: No Study Treatment|Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.
11240039|NCT02475655|EG000|Reported Event|Ruxolitinib|"Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.~Ruxolitinib: 10 mg orally twice daily for 5 weeks"
11240040|NCT02475655|EG001|Reported Event|No Study Treatment|Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.
11240041|NCT02475733|BG000|Baseline|Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11240042|NCT02475733|BG001|Baseline|Meropenem|Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
11240043|NCT02475733|BG002|Baseline|Total|Total of all reporting groups
11240044|NCT02475733|FG000|Participant Flow|Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11240045|NCT02475733|FG001|Participant Flow|Meropenem|Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
11240046|NCT02475733|OG000|Outcome|Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11240047|NCT02475733|OG001|Outcome|Meropenem|Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
11240048|NCT02475733|EG000|Reported Event|Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11240049|NCT02475733|EG001|Reported Event|Meropenem|Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
11240050|NCT02475837|BG000|Baseline|Vorapaxar Intervention|Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.5 mg orally once daily).
11240051|NCT02475837|BG001|Baseline|Placebo Intervention|Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
11240052|NCT02475837|BG002|Baseline|Total|Total of all reporting groups
11240053|NCT02475837|FG000|Participant Flow|Vorapaxar Intervention|Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.5 mg orally once daily).
11240054|NCT02475837|FG001|Participant Flow|Placebo Intervention|Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
11240055|NCT02475837|OG000|Outcome|Vorapaxar Intervention|Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.08 mg orally once daily).
11240056|NCT02475837|OG001|Outcome|Placebo Intervention|Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
11240057|NCT02475837|EG000|Reported Event|Vorapaxar Intervention|Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.08 mg orally once daily).
11240058|NCT02475837|EG001|Reported Event|Placebo Intervention|Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
11240059|NCT02475850|BG000|Baseline|Control|"Usual fall prevention care~Usual care"
11240060|NCT02475850|BG001|Baseline|Intervention|"An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's STEADI toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach~Evidence-based tailored fall prevention"
11240061|NCT02475850|BG002|Baseline|Total|Total of all reporting groups
11240062|NCT02475850|FG000|Participant Flow|Intervention - Fall Prevention Standard of Care|"An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's STEADI toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach~Evidence-based tailored fall prevention"
11240063|NCT02475850|FG001|Participant Flow|Control|"Usual fall prevention care~Usual care"
11240064|NCT02475850|OG000|Outcome|Intervention - Fall Prevention Standard of Care|"An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's STEADI toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach~Evidence-based tailored fall prevention"
11240065|NCT02475850|OG001|Outcome|Control|"Usual fall prevention care~Usual care"
11240066|NCT02475850|OG000|Outcome|Fall Prevention Standard of Care|"An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's STEADI toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach~Evidence-based tailored fall prevention"
11240067|NCT02475850|EG000|Reported Event|Intervention - Fall Prevention Standard of Care|"An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's STEADI toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach~Evidence-based tailored fall prevention"
11240068|NCT02475850|EG001|Reported Event|Control|"Usual fall prevention care~Usual care"
10962711|NCT00868218|BG003|Baseline|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
10962712|NCT00868218|BG004|Baseline|Total|Total of all reporting groups
10962713|NCT00868218|FG000|Participant Flow|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
11240069|NCT02475954|BG000|Baseline|TH-CBT + Standard Care|"Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD).~TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home.~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring)."
11240070|NCT02475954|BG001|Baseline|Standard Care|"VA standard care depression in Parkinson's Disease (PD)~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring)."
11240071|NCT02475954|BG002|Baseline|Total|Total of all reporting groups
11240072|NCT02475954|FG000|Participant Flow|TH-CBT + Standard Care|"Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD).~TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home.~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring)."
11240073|NCT02475954|FG001|Participant Flow|Standard Care|"VA standard care depression in Parkinson's Disease (PD)~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable anti-depressant medications, established psychotherapy, clinical monitoring)."
11336658|NCT03570047|BG000|Baseline|Warfarin|OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11363357|NCT01727167|EG000|Reported Event|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
11363358|NCT01727167|EG001|Reported Event|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
11363359|NCT01732913|BG000|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
11363360|NCT01732913|BG001|Baseline|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
11363361|NCT01732913|BG002|Baseline|Total|Total of all reporting groups
11363362|NCT01732913|FG000|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
11363363|NCT01732913|FG001|Participant Flow|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
11363364|NCT01732913|OG000|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
11363365|NCT01732913|OG001|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
11363366|NCT01732913|EG000|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
11363367|NCT01732913|EG001|Reported Event|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
11363368|NCT01732211|BG000|Baseline|PD 0360324 100 mg Q2W / 150 mg Q2W|PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.
11363369|NCT01732211|FG000|Participant Flow|PD 0360324 100 mg Q2W / 150 mg Q2W|PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.
11363370|NCT01732211|OG000|Outcome|PD 0360324 100 mg Q2W / 150 mg Q2W|PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.
11363371|NCT01732211|EG000|Reported Event|PD 0360324 100 mg Q2W / 150 mg Q2W|PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.
11363372|NCT01716052|BG000|Baseline|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
11363373|NCT01716052|BG001|Baseline|Placebo|"Lactulose~placebo: Lactulose"
11363374|NCT01716052|BG002|Baseline|Total|Total of all reporting groups
11363375|NCT01716052|FG000|Participant Flow|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
11363376|NCT01716052|FG001|Participant Flow|Placebo|"Lactulose~placebo: Lactulose"
11363377|NCT01716052|OG000|Outcome|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
11363378|NCT01716052|OG001|Outcome|Placebo|"Lactulose~placebo: Lactulose"
11363379|NCT01716052|EG000|Reported Event|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
11363380|NCT01716052|EG001|Reported Event|Placebo|"Lactulose~placebo: Lactulose"
11363381|NCT01718444|BG000|Baseline|Group A (No PIES)|"Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.~CC 50 mg oral for 5 days (Days 3-7)~If no ovulation, CC 100 mg for 5 days (Days 12-16)~If no ovulation, CC 150 mg for 5 days (Day 21-25)~Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles~Clomiphene Citrate"
11363382|NCT01718444|BG001|Baseline|Group B (PIES Group)|"Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)~Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)~CC 50 mg oral for 5 days (Day 3-7)~If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses~If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days~Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles~Progestin~Clomiphene Citrate"
11363383|NCT01718444|BG002|Baseline|Total|Total of all reporting groups
11363384|NCT01718444|FG000|Participant Flow|Group A (No PIES)|"Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.~CC 50 mg oral for 5 days (Days 3-7)~If no ovulation, CC 100 mg for 5 days (Days 12-16)~If no ovulation, CC 150 mg for 5 days (Day 21-25)~Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles~Clomiphene Citrate"
11363385|NCT01718444|FG001|Participant Flow|Group B (PIES Group)|"Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)~Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)~CC 50 mg oral for 5 days (Day 3-7)~If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses~If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days~Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles~Progestin~Clomiphene Citrate"
11363386|NCT01718444|OG000|Outcome|Group A (No PIES)|"Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.~CC 50 mg oral for 5 days (Days 3-7)~If no ovulation, CC 100 mg for 5 days (Days 12-16)~If no ovulation, CC 150 mg for 5 days (Day 21-25)~Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles~Clomiphene Citrate"
11363387|NCT01718444|OG001|Outcome|Group B (PIES Group)|"Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)~Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)~CC 50 mg oral for 5 days (Day 3-7)~If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses~If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days~Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles~Progestin~Clomiphene Citrate"
11363388|NCT01718444|EG000|Reported Event|Group A (No PIES)|"Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.~CC 50 mg oral for 5 days (Days 3-7)~If no ovulation, CC 100 mg for 5 days (Days 12-16)~If no ovulation, CC 150 mg for 5 days (Day 21-25)~Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles~Clomiphene Citrate"
11363389|NCT01718444|EG001|Reported Event|Group B (PIES Group)|"Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)~Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)~CC 50 mg oral for 5 days (Day 3-7)~If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses~If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days~Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles~Progestin~Clomiphene Citrate"
11363390|NCT01712854|BG000|Baseline|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
11363391|NCT01712854|FG000|Participant Flow|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
11363392|NCT01712854|OG000|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
11363393|NCT01712854|EG000|Reported Event|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
11363394|NCT01717482|BG000|Baseline|Metformin|"Metformin 850mg twice per day~Metformin"
11363395|NCT01717482|BG001|Baseline|Observation|"Standard of Care Observation~Placebo Comparator: Standard of Care Observation"
11363396|NCT01717482|BG002|Baseline|Total|Total of all reporting groups
11363397|NCT01717482|FG000|Participant Flow|Metformin|"Metformin 850mg twice per day~Metformin"
11363398|NCT01717482|FG001|Participant Flow|Observation|"Standard of Care Observation~Placebo Comparator: Standard of Care Observation"
11363399|NCT01717482|OG000|Outcome|Metformin|"Metformin 850mg twice per day~Metformin"
11363400|NCT01717482|OG001|Outcome|Observation|"Standard of Care Observation~Placebo Comparator: Standard of Care Observation"
11363401|NCT01717482|OG000|Outcome|Metformin|"Metformin 850mg twice a day~Metformin"
11363402|NCT01717482|EG000|Reported Event|Metformin|"Metformin 850mg twice per day~Metformin"
11363403|NCT01717482|EG001|Reported Event|Observation|"Standard of Care Observation~Placebo Comparator: Standard of Care Observation"
11363404|NCT01702896|BG000|Baseline|Number of Participants|Treated with Interleukin-2
11363405|NCT01702896|FG000|Participant Flow|Interleukin-2|All patients received Interleukin-2
11363406|NCT01702896|OG000|Outcome|Response Rate|Percentage of patient who received IL-2 that had a positive response to treatment.
11363407|NCT01702896|OG000|Outcome|Interleukin-2|"Interleukin-2~Interleukin-2: Interleukin-2"
11363408|NCT01702896|OG000|Outcome|Median Survival|Median survival was measured from date of entry on study until date of death
11363409|NCT01702896|EG000|Reported Event|Adverse Events|Patients receiving Interleukin-2
11363410|NCT01709136|BG000|Baseline|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
11363411|NCT01709136|FG000|Participant Flow|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the Children's Hospital of Pittsburgh Pediatric Clinical and Translational Research Center (PCTRC) - See more at: http://www.chp.edu/research/our-facilities/pctrc, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate Glomerular Filtration Rate (GFR) evaluation, or a few days later at the convenience of the subject.
11363412|NCT01709136|OG000|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
11363413|NCT01709136|OG000|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab..
11363414|NCT01709136|OG000|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
11363415|NCT01709136|OG000|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
11363416|NCT01709136|EG000|Reported Event|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
11363417|NCT01708057|BG000|Baseline|Total Baseline|All Patients population
11363418|NCT01708057|FG000|Participant Flow|AFBECD|AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug
11363419|NCT01708057|FG001|Participant Flow|FEADBC|Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug
11363420|NCT01708057|FG002|Participant Flow|DCEBFA|AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug
11363421|NCT01708057|OG000|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
11363422|NCT01708057|OG001|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
11363423|NCT01708057|OG002|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
11188830|NCT02116205|FG001|Participant Flow|Vaccine at 1.0 mg|"1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11363424|NCT01708057|OG003|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
11363425|NCT01708057|OG004|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
11363426|NCT01708057|OG005|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
11363427|NCT01708057|EG000|Reported Event|50ug AZD8683|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
11363428|NCT01708057|EG001|Reported Event|150 ug AZD8683|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
11363429|NCT01708057|EG002|Reported Event|300 ug AZD8683|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
11363430|NCT01708057|EG003|Reported Event|900 ug AZD8683|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler;
11363431|NCT01708057|EG004|Reported Event|18ug Spiriva|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
11363432|NCT01708057|EG005|Reported Event|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
11363433|NCT01697332|BG000|Baseline|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
11363434|NCT01697332|FG000|Participant Flow|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
11363435|NCT01697332|OG000|Outcome|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
11363436|NCT01697332|EG000|Reported Event|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
11363437|NCT01693367|BG000|Baseline|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
11363438|NCT01693367|BG001|Baseline|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
11363439|NCT01693367|BG002|Baseline|Total|Total of all reporting groups
11363440|NCT01693367|FG000|Participant Flow|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
11363441|NCT01693367|FG001|Participant Flow|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
11363442|NCT01693367|OG000|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
11363443|NCT01693367|OG001|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
11363444|NCT01693367|EG000|Reported Event|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
11363445|NCT01693367|EG001|Reported Event|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
11363446|NCT01705106|BG000|Baseline|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
11363447|NCT01705106|FG000|Participant Flow|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
11363448|NCT01705106|OG000|Outcome|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
11363449|NCT01705106|EG000|Reported Event|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
11363450|NCT01702909|BG000|Baseline|Number of Participants|Treated with Interleukin-2
11363451|NCT01702909|FG000|Participant Flow|Interleukin-2|Interleukin 2 (IL-2) is naturally produced by the body to help fight infection and prevent autoimmune diseases. In cancer treatment, IL-2 is designed to target adaptive immune cells, such as T-cells and B-cells, to respond to tumors. IL-2 may help the body produce antigen-fighting T-cells and stimulate B-cells to produce more antibodies.
11363452|NCT01702909|OG000|Outcome|Response Rate|Percentage of Patients Responding to Interleukin-2
11363453|NCT01702909|EG000|Reported Event|Adverse Events|Patients receiving Interleukin-2
11363454|NCT01701622|BG000|Baseline|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
11363455|NCT01701622|FG000|Participant Flow|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
11363456|NCT01701622|OG000|Outcome|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat: If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
11363457|NCT01701622|OG000|Outcome|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat: If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.~as reported earlier (2013), no statistical analysis because of no study participate completion"
11363458|NCT01701622|EG000|Reported Event|Febuxostat|Febuxostat group. The primary outcome of the study is the 24 hour ABPM differences while participants were taking allopurinol compared to taking febuxostat.
11363459|NCT01697800|BG000|Baseline|Placebo|Patients received placebo capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
11363460|NCT01697800|BG001|Baseline|Tadalafil|Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
11363461|NCT01697800|BG002|Baseline|Total|Total of all reporting groups
11363462|NCT01697800|FG000|Participant Flow|Placebo|Patients received placebo capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
11363463|NCT01697800|FG001|Participant Flow|Tadalafil|Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
11363464|NCT01697800|OG000|Outcome|Placebo|Patients received placebo capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
11363465|NCT01697800|OG001|Outcome|Tadalafil|Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
11363466|NCT01697800|EG000|Reported Event|Placebo|Patients received placebo capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
11363467|NCT01697800|EG001|Reported Event|Tadalafil|Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
11363468|NCT01700348|BG000|Baseline|All Randomized Subjects|The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.
11363469|NCT01700348|FG000|Participant Flow|All Enrolled Subjects|Airflosser & Manual Floss
11363470|NCT01700348|OG000|Outcome|All Randomized Subjects|"The study was terminated early, data were not analyzed and the plaque samples were destroyed."
11363471|NCT01700348|OG000|Outcome|All Randomized Subjects|The study was terminated early, data were not analyzed and the plaque samples were destroyed.
11363472|NCT01700348|OG000|Outcome|All Randomized Subjects|The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.
11363473|NCT01700348|EG000|Reported Event|All Randomized Subjects|Summary of AEs for All Randomized Subjects
11363474|NCT01693484|BG000|Baseline|Operative Calcaneus Fracture|Patients with indications for and electing to undergo operative repair of intra articular calcaneus fracture through extended lateral approach
11363475|NCT01693484|FG000|Participant Flow|Displaced Intra Articular Calcaneus Fracture|displaced intra articular calcaneus fracture with operative repair
11363476|NCT01693484|OG000|Outcome|ICG Administered|"The ICG dose (10 mg/4cc per image capture) will be administered in its entirety via push injection through IV access established for standard surgical procedure, followed by 10 cc Normal Saline bolus. This ICG dose will be administered twice, 1X prior to anesthesia, and 1X after the tourniquet on operative extremity has been removed for at least 15 minutes.~ICG (Indocyanine Green): Diagnostic drug used for visualisation of blood perfusion in various tissues.Administered intravenously, 2X: 1X prior to anesthesia, and 1X after tourniquet on operative extremity has been released for at least 15 minutes. When excited by laser light source, it subsequently emits at a near infrared frequency."
11363477|NCT01693484|EG000|Reported Event|Unanticipated Adverse Events Related to ICG|No adverse events related to administration ICG
11188831|NCT02116205|FG002|Participant Flow|Vaccine + Placebo at 2.0 mg|"2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~Placebo: 0.9% sodium chloride~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11363478|NCT01693653|BG000|Baseline|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
11363479|NCT01693653|BG001|Baseline|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
11363480|NCT01693653|BG002|Baseline|Total|Total of all reporting groups
11363481|NCT01693653|FG000|Participant Flow|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
11363482|NCT01693653|FG001|Participant Flow|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
11363483|NCT01693653|OG000|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
11363484|NCT01693653|OG001|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
11363485|NCT01693653|EG000|Reported Event|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
11363486|NCT01693653|EG001|Reported Event|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
11363487|NCT01692691|BG000|Baseline|Received Treatment|Dacarbazine Carmustine participants
11363488|NCT01692691|FG000|Participant Flow|Dacarbazine Carmustine|All patients received chemotherapy with Dacarbazine and Carmustine
11363489|NCT01692691|OG000|Outcome|Participants 8 Week Survival.|Number of participants who received Dacarbazine + Carmustine Progression Free survival at 8 weeks
11363490|NCT01692691|OG000|Outcome|Response Rate|Dacarbazine Carmustine
11363491|NCT01692691|OG000|Outcome|Dacarbazine Carmustine|All patients received chemotherapy with Dacarbazine and Carmustine
11363492|NCT01692691|EG000|Reported Event|Received Treatment|Number of Participants who received Dacarbazine Carmustine
11363493|NCT01691079|BG000|Baseline|Placebo|"placebo 2 puffs prior to exercise challenge~Placebo: Inhaled placebo administered before exercise."
11363494|NCT01691079|BG001|Baseline|Ipratropium Bromide|"ipratropium bromide HFA 2 puffs prior to exercise challenge~ipratropium bromide: Inhaled ipratropium bromide administered before exercise."
11363495|NCT01691079|BG002|Baseline|Total|Total of all reporting groups
11363496|NCT01691079|FG000|Participant Flow|Placebo|"placebo 2 puffs prior to exercise challenge~Placebo: Inhaled placebo administered before exercise."
11363497|NCT01691079|FG001|Participant Flow|Ipratropium Bromide|"ipratropium bromide HFA 2 puffs prior to exercise challenge~ipratropium bromide: Inhaled ipratropium bromide administered before exercise."
11363498|NCT01691079|OG000|Outcome|Placebo|"placebo 2 puffs prior to exercise challenge~Placebo: Inhaled placebo administered before exercise."
11363499|NCT01691079|OG001|Outcome|Ipratropium Bromide|"ipratropium bromide HFA 2 puffs prior to exercise challenge~ipratropium bromide: Inhaled ipratropium bromide administered before exercise."
11363500|NCT01691079|EG000|Reported Event|Placebo|"placebo 2 puffs prior to exercise challenge~Placebo: Inhaled placebo administered before exercise."
11363501|NCT01691079|EG001|Reported Event|Ipratropium Bromide|"ipratropium bromide HFA 2 puffs prior to exercise challenge~ipratropium bromide: Inhaled ipratropium bromide administered before exercise."
11363502|NCT01690910|BG000|Baseline|Front Wheeled Walker|"The Front Wheeled Walker is a standard walker that is used to assist patients while walking.~Front Wheeled Walker"
11363503|NCT01690910|BG001|Baseline|Rifton Gait Trainer|"The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.~Rifton Gait Trainer"
11363504|NCT01690910|BG002|Baseline|Total|Total of all reporting groups
11363505|NCT01690910|FG000|Participant Flow|Front Wheeled Walker|"The Front Wheeled Walker is a standard walker that is used to assist patients while walking.~Front Wheeled Walker"
11188832|NCT02116205|FG003|Participant Flow|Vaccine at 2.0 mg|"2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188833|NCT02116205|OG000|Outcome|Vaccine + Placebo at 1.0 mg|"1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~Placebo: 0.9% sodium chloride~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188834|NCT02116205|OG001|Outcome|Vaccine at 1.0 mg|"1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188835|NCT02116205|OG002|Outcome|Vaccine + Placebo at 2.0 mg|"2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~Placebo: 0.9% sodium chloride~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188836|NCT02116205|OG003|Outcome|Vaccine at 2.0 mg|"2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188837|NCT02116205|EG000|Reported Event|Vaccine + Placebo at 1.0 mg|"1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~Placebo: 0.9% sodium chloride~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188838|NCT02116205|EG001|Reported Event|Vaccine at 1.0 mg|"1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188839|NCT02116205|EG002|Reported Event|Vaccine + Placebo at 2.0 mg|"2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~Placebo: 0.9% sodium chloride~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188840|NCT02116205|EG003|Reported Event|Vaccine at 2.0 mg|"2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.~HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)~TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses"
11188841|NCT02116309|BG000|Baseline|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
11188842|NCT02116309|BG001|Baseline|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
11188843|NCT02116309|BG002|Baseline|Total|Total of all reporting groups
11188844|NCT02116309|FG000|Participant Flow|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
11188845|NCT02116309|FG001|Participant Flow|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
11188846|NCT02116309|OG000|Outcome|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
11188847|NCT02116309|OG001|Outcome|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
11188848|NCT02116309|EG000|Reported Event|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
11188849|NCT02116309|EG001|Reported Event|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
11188850|NCT02116322|BG000|Baseline|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
11188851|NCT02116322|FG000|Participant Flow|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
11188852|NCT02116322|OG000|Outcome|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
11188853|NCT02116322|EG000|Reported Event|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
11188854|NCT02116361|BG000|Baseline|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
11188855|NCT02116361|BG001|Baseline|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
11188856|NCT02116361|BG002|Baseline|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
11188857|NCT02116361|BG003|Baseline|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
11188858|NCT02116361|BG004|Baseline|Total|Total of all reporting groups
11188859|NCT02116361|FG000|Participant Flow|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
11188860|NCT02116361|FG001|Participant Flow|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
11188861|NCT02116361|FG002|Participant Flow|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
11188862|NCT02116361|FG003|Participant Flow|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
11188863|NCT02116361|OG000|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
11188864|NCT02116361|OG001|Outcome|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
11188865|NCT02116361|OG002|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
11188866|NCT02116361|OG003|Outcome|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
11188867|NCT02116361|EG000|Reported Event|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
11188868|NCT02116361|EG001|Reported Event|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
11363506|NCT01690910|FG001|Participant Flow|Rifton Gait Trainer|"The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.~Rifton Gait Trainer"
11188869|NCT02116361|EG002|Reported Event|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
11188870|NCT02116361|EG003|Reported Event|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
11188871|NCT02116530|BG000|Baseline|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
11188872|NCT02116530|BG001|Baseline|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
11188873|NCT02116530|BG002|Baseline|Total|Total of all reporting groups
11188874|NCT02116530|FG000|Participant Flow|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
11336659|NCT03570047|BG001|Baseline|Apixaban|OACs treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11363507|NCT01690910|OG000|Outcome|Front Wheeled Walker|"The Front Wheeled Walker is a standard walker that is used to assist patients while walking.~Front Wheeled Walker"
11188875|NCT02116530|FG001|Participant Flow|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
11188876|NCT02116530|OG000|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
11188877|NCT02116530|OG001|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
11188878|NCT02116530|EG000|Reported Event|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
11188879|NCT02116530|EG001|Reported Event|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
11188880|NCT02116582|BG000|Baseline|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
11188881|NCT02116582|FG000|Participant Flow|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
11188882|NCT02116582|OG000|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
11188883|NCT02116582|EG000|Reported Event|Enzalutamide Total|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
11188884|NCT02116608|BG000|Baseline|Group 1: Betadine|"Apply locally as needed.~Betadine: Apply locally as needed."
11188885|NCT02116608|BG001|Baseline|Group 2: Hydrocortisone Butyrate Cream, 1.0%|"Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.~Hydrocortisone Butyrate Cream, 1.0%: Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition."
11188886|NCT02116608|BG002|Baseline|Group 3: Silver Nitrate|"Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.~Silver Nitrate: Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated."
11188887|NCT02116608|BG003|Baseline|Total|Total of all reporting groups
11188888|NCT02116608|FG000|Participant Flow|Group 1: Betadine|"Apply locally as needed.~Betadine: Apply locally as needed."
11188889|NCT02116608|FG001|Participant Flow|Group 2: Hydrocortisone Butyrate Cream, 1.0%|"Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.~Hydrocortisone Butyrate Cream, 1.0%: Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition."
11188890|NCT02116608|FG002|Participant Flow|Group 3: Silver Nitrate|"Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.~Silver Nitrate: Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated."
11188891|NCT02116608|OG000|Outcome|Group 1: Betadine|"Apply locally as needed.~Betadine: Apply locally as needed."
11363508|NCT01690910|OG001|Outcome|Rifton Gait Trainer|"The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.~Rifton Gait Trainer"
11363509|NCT01690910|EG000|Reported Event|Front Wheeled Walker|"The Front Wheeled Walker is a standard walker that is used to assist patients while walking.~Front Wheeled Walker"
11363510|NCT01690910|EG001|Reported Event|Rifton Gait Trainer|"The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.~Rifton Gait Trainer"
11363511|NCT01689974|BG000|Baseline|Arm A: Ipilimumab|"Ipilimumab administered alone Day 4, 25, 46, and 67~Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67."
11188892|NCT02116608|OG001|Outcome|Group 2: Hydrocortisone Butyrate Cream, 1.0%|"Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.~Hydrocortisone Butyrate Cream, 1.0%: Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition."
11188893|NCT02116608|OG002|Outcome|Group 3: Silver Nitrate|"Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.~Silver Nitrate: Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated."
11188894|NCT02116608|EG000|Reported Event|Group 1: Betadine|"Apply locally as needed.~Betadine: Apply locally as needed."
11188895|NCT02116608|EG001|Reported Event|Group 2: Hydrocortisone Butyrate Cream, 1.0%|"Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.~Hydrocortisone Butyrate Cream, 1.0%: Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition."
11188896|NCT02116608|EG002|Reported Event|Group 3: Silver Nitrate|"Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.~Silver Nitrate: Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated."
11188897|NCT02116621|BG000|Baseline|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
11188898|NCT02116621|BG001|Baseline|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
11188899|NCT02116621|BG002|Baseline|Total|Total of all reporting groups
11188900|NCT02116621|FG000|Participant Flow|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
11188901|NCT02116621|FG001|Participant Flow|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
11188902|NCT02116621|OG000|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
11363512|NCT01689974|BG001|Baseline|Arm B: Ipilimumab and Radiation|"Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.~Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67."
11363513|NCT01689974|BG002|Baseline|Total|Total of all reporting groups
11363514|NCT01689974|FG000|Participant Flow|Arm A: Ipilimumab|"Ipilimumab administered alone Day 4, 25, 46, and 67~Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67."
11188903|NCT02116621|OG001|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
11188904|NCT02116621|EG000|Reported Event|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
11188905|NCT02116621|EG001|Reported Event|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
11363515|NCT01689974|FG001|Participant Flow|Arm B: Ipilimumab and Radiation|"Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.~Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67."
11363516|NCT01689974|OG000|Outcome|Arm A: Ipilimumab|"Ipilimumab administered alone Day 4, 25, 46, and 67~Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67."
11363517|NCT01689974|OG001|Outcome|Arm B: Ipilimumab and Radiation|"Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.~Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67."
11363518|NCT01689974|EG000|Reported Event|Arm A: Ipilimumab|"Ipilimumab administered alone Day 4, 25, 46, and 67~Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67."
11240074|NCT02475954|OG000|Outcome|TH-CBT + Standard Care|"Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD).~TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-home.~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring)."
11240075|NCT02475954|OG001|Outcome|Standard Care|"VA standard care depression in Parkinson's Disease (PD)~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring)."
11240076|NCT02475954|OG000|Outcome|TH-CBT + Standard Care|"Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD).~TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home.~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring)."
11240077|NCT02475954|EG000|Reported Event|TH-CBT + Standard Care|"Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD).~TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home.~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring)."
11240078|NCT02475954|EG001|Reported Event|Standard Care|"VA standard care depression in Parkinson's Disease (PD)~Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring)."
11240079|NCT02475980|BG000|Baseline|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
11240080|NCT02475980|FG000|Participant Flow|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
11240081|NCT02475980|OG000|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
11240082|NCT02475980|EG000|Reported Event|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
11240083|NCT02476032|BG000|Baseline|Prof Applied Oxalate|"Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied oxalate: Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
11240084|NCT02476032|BG001|Baseline|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied oxalate: Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
11240085|NCT02476032|BG002|Baseline|Prof Applied Placebo|"Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied placebo: Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional."
11240086|NCT02476032|BG003|Baseline|Total|Total of all reporting groups
11240087|NCT02476032|FG000|Participant Flow|Prof Applied Oxalate|"Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Professionally applied Crest Sensi-Stop strips (Procter & Gamble™): Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
11240088|NCT02476032|FG001|Participant Flow|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied Crest Sensi-Stop strips (Procter & Gamble™): Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
11240089|NCT02476032|FG002|Participant Flow|Prof Applied Placebo|Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.
11240090|NCT02476032|OG000|Outcome|Prof Applied Oxalate|"Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Professionally applied Crest Sensi-Stop strips (Procter & Gamble™): Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
11240091|NCT02476032|OG001|Outcome|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied Crest Sensi-Stop strips (Procter & Gamble™): Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
11240092|NCT02476032|OG002|Outcome|Prof Applied Placebo|Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.
11240093|NCT02476032|OG000|Outcome|Prof Applied Oxalate|"Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied oxalate: Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
11240094|NCT02476032|OG001|Outcome|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied oxalate: Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
11240095|NCT02476032|OG002|Outcome|Prof Applied Placebo|"Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied placebo: Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional."
11240096|NCT02476032|EG000|Reported Event|Prof Applied Oxalate|"Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied oxalate: Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
11363519|NCT01689974|EG001|Reported Event|Arm B: Ipilimumab and Radiation|"Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.~Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67."
11363520|NCT01676961|BG000|Baseline|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
11363521|NCT01676961|FG000|Participant Flow|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
11363522|NCT01676961|OG000|Outcome|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
11363523|NCT01676961|EG000|Reported Event|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
11363524|NCT01681589|BG000|Baseline|Control Group|"The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).~Control Group: This group will receive Sham TDCS"
11363525|NCT01681589|BG001|Baseline|Transcranial Direct Current Stimulator (TDCS)|"The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.~Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS"
11363526|NCT01681589|BG002|Baseline|Healthy Control Group|"Fifteen (15) healthy control subjects will participate.~Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits."
11363527|NCT01681589|BG003|Baseline|Total|Total of all reporting groups
11363528|NCT01681589|FG000|Participant Flow|Control Group|"The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).~Control Group: This group will receive Sham TDCS"
11363529|NCT01681589|FG001|Participant Flow|Transcranial Direct Current Stimulator (TDCS)|"The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.~Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS"
11363530|NCT01681589|FG002|Participant Flow|Healthy Control Group|"Fifteen (15) healthy control subjects will participate.~Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits."
11363531|NCT01681589|OG000|Outcome|Control Group|"The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).~Control Group: This group will receive Sham TDCS"
11363532|NCT01681589|OG001|Outcome|Transcranial Direct Current Stimulator (TDCS)|"The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.~Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS"
11363533|NCT01681589|OG002|Outcome|Healthy Control Group|"Fifteen (15) healthy control subjects will participate.~Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits."
11363534|NCT01681589|EG000|Reported Event|Control Group|"The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).~Control Group: This group will receive Sham TDCS"
11363535|NCT01681589|EG001|Reported Event|Transcranial Direct Current Stimulator (TDCS)|"The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.~Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS"
11363536|NCT01681589|EG002|Reported Event|Healthy Control Group|"Fifteen (15) healthy control subjects will participate.~Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits."
11363537|NCT01681745|BG000|Baseline|Cryo-Touch Treatment|Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
11363538|NCT01681745|FG000|Participant Flow|Cryo-Touch Treatment|Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
11363539|NCT01681745|OG000|Outcome|Cryo-Touch Treatment|Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
11363540|NCT01681745|EG000|Reported Event|Cryo-Touch Treatment|Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
11363541|NCT01682928|BG000|Baseline|IV/Oral Hydration and Bedrest|"IV/Oral Hydration and Bedrest:~Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~AFI (Baseline, day 3, 7 {or Discharge})~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital signs"
11188906|NCT02116660|BG000|Baseline|Raltegravir Plus Nevirapine Plus Lamivudine|Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks
11188907|NCT02116660|BG001|Baseline|Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine|Tenofovir/emtricitabine 300/200 mg orally once daily plus 1) lopinavir/ritonavir 400/100 mg orally twice daily or 800/200 mg orally once daily, or 2) atazanavir/ritonavir 300/100 mg orally once daily, or 3) darunavir/ritonavir 800/100 mg orally once daily or 600/100 mg orally twice daily
11188908|NCT02116660|BG002|Baseline|Total|Total of all reporting groups
11188909|NCT02116660|FG000|Participant Flow|Raltegravir Plus Nevirapine Plus Lamivudine|Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks
11188910|NCT02116660|FG001|Participant Flow|Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine|Tenofovir/emtricitabine 300/200 mg orally once daily plus 1) lopinavir/ritonavir 400/100 mg orally twice daily or 800/200 mg orally once daily, or 2) atazanavir/ritonavir 300/100 mg orally once daily, or 3) darunavir/ritonavir 800/100 mg orally once daily or 600/100 mg orally twice daily
11188911|NCT02116660|OG000|Outcome|Raltegravir Plus Nevirapine Plus Lamivudine|Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks
11188912|NCT02116660|OG001|Outcome|Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine|Tenofovir/emtricitabine 300/200 mg orally once daily plus 1) lopinavir/ritonavir 400/100 mg orally twice daily or 800/200 mg orally once daily, or 2) atazanavir/ritonavir 300/100 mg orally once daily, or 3) darunavir/ritonavir 800/100 mg orally once daily or 600/100 mg orally twice daily
11188913|NCT02116660|OG000|Outcome|Raltegravir|Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks
11188914|NCT02116660|OG001|Outcome|Nevirapine|Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks
11188915|NCT02116660|EG000|Reported Event|Raltegravir Plus Nevirapine Plus Lamivudine|Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks
11188916|NCT02116660|EG001|Reported Event|Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine|Tenofovir/emtricitabine 300/200 mg orally once daily plus 1) lopinavir/ritonavir 400/100 mg orally twice daily or 800/200 mg orally once daily, or 2) atazanavir/ritonavir 300/100 mg orally once daily, or 3) darunavir/ritonavir 800/100 mg orally once daily or 600/100 mg orally twice daily
11188917|NCT02116777|BG000|Baseline|400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188918|NCT02116777|BG001|Baseline|400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188919|NCT02116777|BG002|Baseline|600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188920|NCT02116777|BG003|Baseline|600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188921|NCT02116777|BG004|Baseline|600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188922|NCT02116777|BG005|Baseline|600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188923|NCT02116777|BG006|Baseline|600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day|"Phase 2: Part B~Part B: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET (Phase 2)"
11188924|NCT02116777|BG007|Baseline|Total|Total of all reporting groups
11188925|NCT02116777|FG000|Participant Flow|400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188926|NCT02116777|FG001|Participant Flow|400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188927|NCT02116777|FG002|Participant Flow|600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188928|NCT02116777|FG003|Participant Flow|600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188929|NCT02116777|FG004|Participant Flow|600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188930|NCT02116777|FG005|Participant Flow|600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188931|NCT02116777|FG006|Participant Flow|600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day|"Phase 2: Part B~Part B: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET (Phase 2)"
11188932|NCT02116777|OG000|Outcome|400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11363542|NCT01682928|BG001|Baseline|Hydrotherapy Group|"• HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS~o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy~Hydrotherapy:~Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~o 1 hour +/- 30 minutes after submersion therapy~AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital signs"
11363543|NCT01682928|BG002|Baseline|Total|Total of all reporting groups
11363544|NCT01682928|FG000|Participant Flow|IV/Oral Hydration and Bedrest|"1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation Strict I/O's Vital signs US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~AFI (Baseline, day 3, 7 {or Discharge})"
11363545|NCT01682928|FG001|Participant Flow|Hydrotherapy Group|"US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline,~Uterine Artery Doppler Flow (Baseline,~AFI (Baseline,~Strict I/O's~Vital signs~HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS~o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy Hydrotherapy: • Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow~Uterine Artery Doppler Flow • AFI (Baseline, day 3, 7 {or Discharge})"
11363546|NCT01682928|OG000|Outcome|IV/Oral Hydration and Bedrest|"IV/Oral Hydration and Bedrest for up to 7 days~US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~AFI (Baseline, day 3, 7 {or Discharge})~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital signs~: • Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~AFI (Baseline, day 3, 7 {or Discharge})~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV"
11363547|NCT01682928|OG001|Outcome|Hydrotherapy Group|"HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS~Maternal BP (sitting) US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~o 1 hour +/- 30 minutes after submersion therapy~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~o 1 hour +/- 30 minutes after submersion therapy~AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital signs~Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy~Hydrotherapy: • Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight"
11188933|NCT02116777|OG001|Outcome|400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11363548|NCT01682928|OG000|Outcome|IV/Oral Hydration and Bedrest|"IV/Oral Hydration and Bedrest up to 7 days~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~AFI (Baseline, day 3, 7 {or Discharge})~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital signs~: • Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~AFI (Baseline, day 3, 7 {or Discharge})~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital sign"
11363549|NCT01682928|OG001|Outcome|Hydrotherapy Group|"• HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital signs~Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy~Hydrotherapy: • Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submer"
10962714|NCT00868218|FG001|Participant Flow|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11188934|NCT02116777|OG002|Outcome|600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188935|NCT02116777|OG003|Outcome|600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188936|NCT02116777|OG004|Outcome|600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11363550|NCT01682928|EG000|Reported Event|IV/Oral Hydration and Bedrest|"Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~AFI (Baseline, day 3, 7 {or Discharge})~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital signs~IV/Oral Hydration and Bedrest: • Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~AFI (Baseline, day 3, 7 {or Discharge})"
11363551|NCT01682928|EG001|Reported Event|Hydrotherapy Group|"Maternal BP (sitting)~Pulse Pressure~Pulse~Urine Specific Gravity BID~Fetal Heart Rate~Maternal Body Weight US Procedures~AC/EFW~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~o 1 hour +/- 30 minutes after submersion therapy~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})~o 1 hour +/- 30 minutes after submersion therapy~AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:~1 Liter Water PO over 2 hours~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation~Strict I/O's~Vital signs~HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy"
11363552|NCT01668940|BG000|Baseline|Lillipops Iced Soothies (4 Flavours) (Experimental)|"Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol"
11363553|NCT01668940|BG001|Baseline|Lillipop Iced Soothies (Ginger Flavour) (Experimental)|Initially, women will be given 1 Ginger flavor box of Lillipop samples. Each box contains 24 freezies (20 mL each). Each 20ml contains 80mg of dried ginger root. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 a day and to not have any other popsicles, freezies or other ginger products throughout the duration of the study (7 days). Due ginger's antiemetic property, a maximum daily dose is up to 1000mg/day of dried ginger root powder in pregnancy.They can request an additional box of freezies at each follow-up, as needed.All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.
11363554|NCT01668940|BG002|Baseline|Mr. Freeze Freezies (4 Flavours) (Active Comparator)|"Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol"
11363555|NCT01668940|BG003|Baseline|Natural Course Group (No Intervention)|"Women will not receive any freezies and will be asked to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days).~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol"
11363556|NCT01668940|BG004|Baseline|Total|Total of all reporting groups
11363557|NCT01668940|FG000|Participant Flow|Lillipops Iced Soothies (4 Flavours)|"Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol."
11188937|NCT02116777|OG005|Outcome|600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11363558|NCT01668940|FG001|Participant Flow|Lillipop Iced Soothies (Ginger Flavour)|Initially, women will be given 1 Ginger flavor box of Lillipop samples. Each box contains 24 freezies (20 mL each). Each 20ml contains 80mg of dried ginger root. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 a day and to not have any other popsicles, freezies or other ginger products throughout the duration of the study (7 days). Due ginger's antiemetic property, a maximum daily dose is up to 1000mg/day of dried ginger root powder in pregnancy.They can request an additional box of freezies at each follow-up, as needed.All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.
11188938|NCT02116777|OG006|Outcome|600 mcg/m²/Dose BMN 673 BID+30 mg/m²/Dose TEM,Max 1000 mcg/Day|Part PK
11188939|NCT02116777|OG006|Outcome|600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day|"Phase 2: Part B~Part B: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET (Phase 2)"
11363559|NCT01668940|FG002|Participant Flow|Mr. Freeze Freezies (4 Flavours)|"Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol~Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP."
11363560|NCT01668940|FG003|Participant Flow|Natural Course Group|"Women will not receive any freezies and will be asked to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days).~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol"
11363561|NCT01668940|OG000|Outcome|Lillipops Iced Soothies (4 Flavours)|"Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol."
11363562|NCT01668940|OG001|Outcome|Lillipop Iced Soothies (Ginger Flavour)|Initially, women will be given 1 Ginger flavor box of Lillipop samples. Each box contains 24 freezies (20 mL each). Each 20ml contains 80mg of dried ginger root. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 a day and to not have any other popsicles, freezies or other ginger products throughout the duration of the study (7 days). Due ginger's antiemetic property, a maximum daily dose is up to 1000mg/day of dried ginger root powder in pregnancy.They can request an additional box of freezies at each follow-up, as needed.All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.
11363563|NCT01668940|OG002|Outcome|Mr. Freeze Freezies (4 Flavours)|"Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol~Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP."
11363564|NCT01668940|OG003|Outcome|Natural Course Group|"Women will not receive any freezies and will be asked to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days).~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol"
11188940|NCT02116777|OG000|Outcome|Treatment (Talazoparib, Temozolomide): Phase 1|"(Part A): Patients receive talazoparib PO QD or BID on days 1-6 and temozolomide PO QD on days 2-6. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Talazoparib: Given PO~Temozolomide: Given PO"
11363565|NCT01668940|EG000|Reported Event|Lillipops Iced Soothies (4 Flavours)|"Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol."
11363566|NCT01668940|EG001|Reported Event|Lillipop Iced Soothies (Ginger Flavour)|Initially, women will be given 1 Ginger flavor box of Lillipop samples. Each box contains 24 freezies (20 mL each). Each 20ml contains 80mg of dried ginger root. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 a day and to not have any other popsicles, freezies or other ginger products throughout the duration of the study (7 days). Due ginger's antiemetic property, a maximum daily dose is up to 1000mg/day of dried ginger root powder in pregnancy.They can request an additional box of freezies at each follow-up, as needed.All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.
11188941|NCT02116777|OG000|Outcome|Treatment (Talazoparib, Temozolomide): Phase 2|"(Part B): Relapse/Refractory EWS or PNET Patients receive MTD from Phase 1 portion of study. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Talazoparib: Given PO~Temozolomide: Given PO"
11363567|NCT01668940|EG002|Reported Event|Mr. Freeze Freezies (4 Flavours)|"Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol~Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP."
11363568|NCT01668940|EG003|Reported Event|Natural Course Group|"Women will not receive any freezies and will be asked to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days).~All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol"
11363569|NCT01663285|BG000|Baseline|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
11363570|NCT01663285|FG000|Participant Flow|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
11363571|NCT01663285|OG000|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
11363572|NCT01663285|EG000|Reported Event|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
11363573|NCT01683864|BG000|Baseline|Positive Cytology With HIPEC|gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin
11188942|NCT02116777|EG000|Reported Event|400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11363574|NCT01683864|BG001|Baseline|Positive Cytology no HIPEC|gastric cancer cytology positive without HIPEC
11363575|NCT01683864|BG002|Baseline|Negative Cytology Without HIPEC|gastric cancer with negative cytology
11363576|NCT01683864|BG003|Baseline|Total|Total of all reporting groups
11363577|NCT01683864|FG000|Participant Flow|Positive Cytology With HIPEC|gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin
11363578|NCT01683864|FG001|Participant Flow|Positive Cytology Without HIPEC|gastric cancer cytology positive without HIPEC
11363579|NCT01683864|FG002|Participant Flow|Negative Cytology Without HIPEC|gastric cancer with negative cytology
11363580|NCT01683864|OG000|Outcome|Positive Cytology With HIPEC|gastric Cancer cytology positive with HIPEC
11363581|NCT01683864|OG001|Outcome|Positive Cytology Witout HIPEC|gastric cancer positive cytology without HIPC
11363582|NCT01683864|OG002|Outcome|Negative Cytology Without HIPC|gastric cancer negative cytology without HIPC
11363583|NCT01683864|EG000|Reported Event|Positive Cytology With HIPEC|gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin Adverse Event : NA
11363584|NCT01683864|EG001|Reported Event|Positive Cytology no HIPEC|gastric cancer cytology positive without HIPEC Adverse Event : NA
11363585|NCT01683864|EG002|Reported Event|Negative Cytology Without HIPEC|gastric cancer with negative cytology Adverse Event : NA
11363586|NCT01675011|BG000|Baseline|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
11363587|NCT01675011|BG001|Baseline|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
11363588|NCT01675011|BG002|Baseline|Total|Total of all reporting groups
11363589|NCT01675011|FG000|Participant Flow|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
11363590|NCT01675011|FG001|Participant Flow|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
11363591|NCT01675011|OG000|Outcome|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
11363592|NCT01675011|OG001|Outcome|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
10962715|NCT00868218|FG002|Participant Flow|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11363593|NCT01675011|EG000|Reported Event|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
11363594|NCT01675011|EG001|Reported Event|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
11363595|NCT01673425|BG000|Baseline|Live Attenuated Influenza Vaccine Study|This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed.
11363596|NCT01673425|FG000|Participant Flow|Experimental: Live Attenuated Influenza Vaccine|Single intervention study; all participants receive LAIV
11363597|NCT01673425|OG000|Outcome|Experimental: Live Attenuated Influenza Vaccine|Single Intervention Study
11363598|NCT01673425|EG000|Reported Event|Study Enrollment|Low accrual. Only 4 subjects completed study in 2 month period. Study terminated.
11363599|NCT01673061|BG000|Baseline|Lidocaine|"Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.~Lidocaine: See associated Arm Description"
11188943|NCT02116777|EG001|Reported Event|400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188944|NCT02116777|EG002|Reported Event|600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11363600|NCT01673061|BG001|Baseline|Vapocoolant|"Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.~Vapocoolant: See associated Arm Description"
11363601|NCT01673061|BG002|Baseline|Total|Total of all reporting groups
11363602|NCT01673061|FG000|Participant Flow|Lidocaine|"Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.~Lidocaine: See associated Arm Description"
11363603|NCT01673061|FG001|Participant Flow|Vapocoolant|"Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.~Vapocoolant: See associated Arm Description"
11363604|NCT01673061|OG000|Outcome|Lidocaine|"Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.~Lidocaine: See associated Arm Description"
11363605|NCT01673061|OG001|Outcome|Vapocoolant|"Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.~Vapocoolant: See associated Arm Description"
11363606|NCT01673061|EG000|Reported Event|Lidocaine|"Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.~Lidocaine: See associated Arm Description"
11363607|NCT01673061|EG001|Reported Event|Vapocoolant|"Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.~Vapocoolant: See associated Arm Description"
11363608|NCT01675960|BG000|Baseline|Gabapentin, Then Placebo|Participants first receive gabapentin 3 times per day, with varying dosing based on the protocol. After 34-38 days, a washout period of 3 days occurs, before then receiving the placebo dose for 32 days.
11188945|NCT02116777|EG003|Reported Event|600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11188946|NCT02116777|EG004|Reported Event|600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11363609|NCT01675960|BG001|Baseline|Placebo, Then Gabapentin|Participants first receive placebo 3 times per day. After 34-38 days, a washout period of 3 days occurs, before then receiving Gabapentin, with varying dosing based on the protocol, for 32 days.
11363610|NCT01675960|BG002|Baseline|Total|Total of all reporting groups
11363611|NCT01675960|FG000|Participant Flow|Gabapentin, Then Placebo|Participants first receive gabapentin 3 times per day, with varying dosing based on the protocol. After 34-38 days, a washout period of 3 days occurs, before then receiving the placebo dose for 32 days.
11363612|NCT01675960|FG001|Participant Flow|Placebo, Then Gabapentin|Participants first receive placebo 3 times per day. After 34-38 days, a washout period of 3 days occurs, before then receiving Gabapentin, with varying dosing based on the protocol, for 32 days.
11363613|NCT01675960|OG000|Outcome|Gabapentin|"Neurotin~Gabapentin: The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period."
11363614|NCT01675960|OG001|Outcome|Placebo|"Glycerin based clear solution that is flavored similar to the commercial product~placebo"
11363615|NCT01675960|EG000|Reported Event|Gabapentin|"Neurotin~Gabapentin: The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period."
11363616|NCT01675960|EG001|Reported Event|Placebo|"Glycerin based clear solution that is flavored similar to the commercial product~placebo"
11363617|NCT01668147|BG000|Baseline|Study Arm|"Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging~[11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz"
11363618|NCT01668147|FG000|Participant Flow|PET/CT Imaging|"Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging~[11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz"
11363619|NCT01668147|OG000|Outcome|Control (no Pretreatment)|"Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging~[11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz"
11363620|NCT01668147|OG001|Outcome|Oral Ritonavir|"Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging~[11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz"
11363621|NCT01668147|OG002|Outcome|Oral Efavirenz|"Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging~[11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz"
11363622|NCT01668147|EG000|Reported Event|Control (no Pretreatment)|"Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging~[11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz"
11363623|NCT01668147|EG001|Reported Event|Oral Ritonvir|"Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging~[11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz"
11363624|NCT01668147|EG002|Reported Event|Oral Efavirenz|"Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging~[11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz"
11363625|NCT01676701|BG000|Baseline|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
11363626|NCT01676701|BG001|Baseline|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
11363627|NCT01676701|BG002|Baseline|Total|Total of all reporting groups
11363628|NCT01676701|FG000|Participant Flow|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).
11363629|NCT01676701|FG001|Participant Flow|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
11363630|NCT01676701|OG000|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
11363631|NCT01676701|OG001|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
11363632|NCT01676701|EG000|Reported Event|Tabalumab Auto-Injector (Treatment Period)|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
11363633|NCT01676701|EG001|Reported Event|Tabalumab Auto-Injector (Post Treatment Follow-Up Period)|No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Auto-Injector treatment arm.
11363634|NCT01676701|EG002|Reported Event|Tabalumab Prefilled Syringe (Treatment Period)|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
11363635|NCT01676701|EG003|Reported Event|Tabalumab Prefilled Syringe (Post Treatment Follow-Up Period)|No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Prefilled Syringe treatment arm.
11363636|NCT01669148|BG000|Baseline|All Study Participants|All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms.
11363637|NCT01669148|FG000|Participant Flow|All Study Participants|All participants enrolled in study
11363638|NCT01669148|OG000|Outcome|Conventional + Tomosynthesis First Then Tomo Alone 1 mo. Later|"Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).~Conventional: conventional (2D) imaging (standard mammography)"
11363639|NCT01669148|OG001|Outcome|Tomosynthesis Alone First Then Conventional+Tomo 1 mo. Later|"Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).~Conventional: conventional (2D) imaging (standard mammography)"
11363640|NCT01669148|EG000|Reported Event|All Study Participants|All participants enrolled in the study
11363641|NCT01662102|BG000|Baseline|Zevalin Regimen Consolidation (Group A)|"990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).~The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)"
11363642|NCT01662102|BG001|Baseline|Rituximab Maintenance (Group B)|Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).
11363643|NCT01662102|BG002|Baseline|Total|Total of all reporting groups
11363644|NCT01662102|FG000|Participant Flow|Zevalin Regimen Consolidation (Group A)|"90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 megabecquerel/kilogram (MBq/kg) (0.4 millicurie/kg [mCi/kg] of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).~The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 milligram/meter^2 [mg/m^2]); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)"
11363645|NCT01662102|FG001|Participant Flow|Rituximab Maintenance (Group B)|Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months)
11363646|NCT01662102|OG000|Outcome|Zevalin Regimen Consolidation (Group A)|"90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).~The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)."
11363647|NCT01662102|OG001|Outcome|Rituximab Maintenance (Group B)|Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).
11363648|NCT01662102|OG000|Outcome|Zevalin Regimen Consolidation (Group A)|"990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).~The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)"
11363649|NCT01662102|EG000|Reported Event|Zevalin Regimen Consolidation (Group A)|"90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).~The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)."
11363650|NCT01662102|EG001|Reported Event|Rituximab Maintenance (Group B)|Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).
11363651|NCT01659554|BG000|Baseline|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
11363652|NCT01659554|FG000|Participant Flow|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
11363653|NCT01659554|OG000|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
11363654|NCT01659554|EG000|Reported Event|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
11376263|NCT00980460|BG004|Baseline|High-risk Group (Regimen H)|"Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376264|NCT00980460|BG005|Baseline|Total|Total of all reporting groups
11376265|NCT00980460|FG000|Participant Flow|Very Low-risk Group|"Patients undergo surgery and then receive no further treatment.~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11376266|NCT00980460|FG001|Participant Flow|Low-risk Group (Regimen T)|"Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376267|NCT00980460|FG002|Participant Flow|Intermediate-risk Group (Regimen F)|"Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)~Cisplatin: Given IV~Dexrazoxane: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376268|NCT00980460|FG003|Participant Flow|High-risk Group (Regimen W)|"(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376269|NCT00980460|FG004|Participant Flow|High-risk Group (Regimen H)|"Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376270|NCT00980460|OG000|Outcome|Very Low-risk Group|"Patients undergo surgery and then receive no further treatment.~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11376271|NCT00980460|OG001|Outcome|Low-risk Group (Regimen T)|"Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376272|NCT00980460|OG002|Outcome|Intermediate-risk Group (Regimen F)|"Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)~Cisplatin: Given IV~Dexrazoxane: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11363655|NCT01658813|BG000|Baseline|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
11363656|NCT01658813|FG000|Participant Flow|5-FU and Interferon-alfa-2b|All patients received 5-Fluorouracil and Interferon-alfa-2b
11363657|NCT01658813|OG000|Outcome|Progression Free Survival|5-Fluorouracil and Interferon-alfa-2b
11363658|NCT01658813|OG000|Outcome|Number of Responders|the number of patients responding
11363659|NCT01658813|OG000|Outcome|Response Rate|percentage of patients responding
11363660|NCT01658813|OG000|Outcome|Median Duration of Response|The median duration of response was determined.
11363661|NCT01658813|OG000|Outcome|Median Survival|The median survival of patients treated on study was determined.
11363662|NCT01658813|EG000|Reported Event|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
11363663|NCT01648296|BG000|Baseline|Dosimetry Group|"A total of 12 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363664|NCT01648296|BG001|Baseline|Kinetic Dynamic Group|"A total of 38 subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363665|NCT01648296|BG002|Baseline|Total|Total of all reporting groups
11363666|NCT01648296|FG000|Participant Flow|Dosimetry Group|"A total of 12 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363667|NCT01648296|FG001|Participant Flow|Kinetic Dynamic Group|"A total of 38 subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363668|NCT01648296|OG000|Outcome|Dosimetry Group|"A total of 12 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363669|NCT01648296|OG001|Outcome|Kinetic Dynamic Group|"A total of 38 subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363670|NCT01648296|OG000|Outcome|Dosimetry Group|"A total of 0 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363671|NCT01648296|OG001|Outcome|Kinetic Dynamic Group|"A total of 0subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363672|NCT01648296|EG000|Reported Event|Dosimetry Group|"A total of 12 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363673|NCT01648296|EG001|Reported Event|Kinetic Dynamic Group|"A total of 38 subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.~[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx"
11363674|NCT01649505|BG000|Baseline|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
11363675|NCT01649505|BG001|Baseline|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
11363676|NCT01649505|BG002|Baseline|Total|Total of all reporting groups
11363677|NCT01649505|FG000|Participant Flow|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
11363678|NCT01649505|FG001|Participant Flow|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
11363679|NCT01649505|OG000|Outcome|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
11363680|NCT01649505|OG001|Outcome|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
11363681|NCT01649505|EG000|Reported Event|Arm I (Fibrin Sealant)|Patients undergo sharp dissection technique with fibrin sealant closure.
11363682|NCT01649505|EG001|Reported Event|Arm II (Standard Electrocoagulation)|Patients undergo standard electrocoagulation dissection technique.
11363683|NCT01642732|BG000|Baseline|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
11363684|NCT01642732|FG000|Participant Flow|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
11363685|NCT01642732|OG000|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
11363686|NCT01642732|EG000|Reported Event|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
11363687|NCT01645709|BG000|Baseline|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
11363688|NCT01645709|BG001|Baseline|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
11363689|NCT01645709|BG002|Baseline|Total|Total of all reporting groups
11363690|NCT01645709|FG000|Participant Flow|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
11363691|NCT01645709|FG001|Participant Flow|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
11363692|NCT01645709|OG000|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
11363693|NCT01645709|OG001|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
11363694|NCT01645709|EG000|Reported Event|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
11363695|NCT01645709|EG001|Reported Event|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
11363696|NCT01648270|BG000|Baseline|Study Arm|"Subjects will be studied on four occasions. Sessions and drugs are:~Intravenous buprenorphine~Sublingual buprenorphine~Cyclosporine plus intravenous buprenorphine~Cyclosporine plus sublingual buprenorphine"
11363697|NCT01648270|FG000|Participant Flow|Buprenorphine|"Subjects will be studied on four occasions. Sessions and drugs are:~Intravenous buprenorphine~Sublingual buprenorphine~Cyclosporine plus intravenous buprenorphine~Cyclosporine plus sublingual buprenorphine"
11363698|NCT01648270|OG000|Outcome|Intravenous Buprenorphine|Intravenous buprenorphine: 0.2 mg infused over 1 hr
11363699|NCT01648270|OG001|Outcome|Sublingual Buprenorphine|Sublingual buprenorphine: 2 mg
11363700|NCT01648270|OG002|Outcome|Cyclosporine + IV Buprenorphine|Cyclosporine (2.5mg/kg/hr infused over 2 hr), then intravenous buprenor-phine 0.2 mg infused over 1 hr beginning 1 hr after starting cyclosporine. Subjects then take oral cyclosporine 4.5 mg/kg twice daily
11363701|NCT01648270|OG003|Outcome|Cyclosporine + Sublingual Buprenorphine|Sublingual buprenorphine: 2 mg; continue oral cyclosporine 4.5 mg/kg twice daily for 5 days
11363702|NCT01648270|EG000|Reported Event|Intravenous Buprenorphine|Intravenous buprenorphine: 0.2 mg infused over 1 hr
11363703|NCT01648270|EG001|Reported Event|Sublingual Buprenorphine|Sublingual buprenorphine: 2 mg
11363704|NCT01648270|EG002|Reported Event|Cyclosporine Plus Intravenous Buprenorphine|Cyclosporine (2.5mg/kg/hr infused over 2 hr), then intravenous buprenor-phine 0.2 mg infused over 1 hr beginning 1 hr after starting cyclosporine. Subjects then take oral cyclosporine 4.5 mg/kg twice daily
11363705|NCT01648270|EG003|Reported Event|Cyclosporine Plus Sublingual Buprenorphine|Sublingual buprenorphine: 2 mg; continue oral cyclosporine 4.5 mg/kg twice daily for 5 days
11363706|NCT01643525|BG000|Baseline|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
11363707|NCT01643525|FG000|Participant Flow|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
11363708|NCT01643525|OG000|Outcome|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
11363709|NCT01643525|EG000|Reported Event|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
11363710|NCT01641601|BG000|Baseline|Usual Management|Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis.
11363711|NCT01641601|BG001|Baseline|Outpatient Transcervical Foley Balloon|"Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols.~Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction."
11363712|NCT01641601|BG002|Baseline|Total|Total of all reporting groups
11363713|NCT01641601|FG000|Participant Flow|Usual Management|Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis.
11363714|NCT01641601|FG001|Participant Flow|Outpatient Transcervical Foley Balloon|"Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols.~Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction."
11363715|NCT01641601|OG000|Outcome|Usual Management|Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis.
11363716|NCT01641601|OG001|Outcome|Outpatient Transcervical Foley Balloon|"Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols.~Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction."
11363717|NCT01641601|EG000|Reported Event|Usual Management|Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis.
11363718|NCT01641601|EG001|Reported Event|Outpatient Transcervical Foley Balloon|"Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols.~Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction."
11363719|NCT01633814|BG000|Baseline|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
11363720|NCT01633814|FG000|Participant Flow|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
11363721|NCT01633814|OG000|Outcome|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
11363722|NCT01633814|EG000|Reported Event|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
11363723|NCT01636466|BG000|Baseline|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
11363724|NCT01636466|BG001|Baseline|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
11363725|NCT01636466|BG002|Baseline|Total|Total of all reporting groups
11363726|NCT01636466|FG000|Participant Flow|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
11363727|NCT01636466|FG001|Participant Flow|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
11363728|NCT01636466|OG000|Outcome|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
11363729|NCT01636466|OG001|Outcome|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
11336660|NCT03570047|BG002|Baseline|Dabigatran|OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336661|NCT03570047|BG003|Baseline|Rivaroxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336662|NCT03570047|BG004|Baseline|Edoxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated edoxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336663|NCT03570047|BG005|Baseline|Total|Total of all reporting groups
11336664|NCT03570047|FG000|Participant Flow|Warfarin|Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336665|NCT03570047|FG001|Participant Flow|Apixaban|OACs treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336666|NCT03570047|FG002|Participant Flow|Dabigatran|OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336667|NCT03570047|FG003|Participant Flow|Rivaroxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336668|NCT03570047|FG004|Participant Flow|Edoxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated edoxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336669|NCT03570047|OG000|Outcome|Warfarin|OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336670|NCT03570047|OG001|Outcome|Apixaban|OACs treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336671|NCT03570047|OG002|Outcome|Dabigatran|OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336672|NCT03570047|OG003|Outcome|Rivaroxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336673|NCT03570047|OG004|Outcome|Edoxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated edoxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336674|NCT03570047|EG000|Reported Event|Warfarin|OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336675|NCT03570047|EG001|Reported Event|Apixaban|OACs treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11363730|NCT01636466|EG000|Reported Event|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
11363731|NCT01636466|EG001|Reported Event|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
11363732|NCT01629329|BG000|Baseline|Aspirin, Acetaminophen, Caffeine Pills|"Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline.~Aspirin, Acetaminophen, Caffeine pills: One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV)"
11363733|NCT01629329|BG001|Baseline|Prochlorperazine 10mg|"Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills~Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills."
11363734|NCT01629329|BG002|Baseline|Total|Total of all reporting groups
11363735|NCT01629329|FG000|Participant Flow|Aspirin, Acetaminophen, Caffeine Pills|"Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline.~Aspirin, Acetaminophen, Caffeine pills: One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV)"
11363736|NCT01629329|FG001|Participant Flow|Prochlorperazine 10mg|"Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills~Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills."
11363737|NCT01629329|OG000|Outcome|Aspirin, Acetaminophen, Caffeine Pills|"Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline.~Aspirin, Acetaminophen, Caffeine pills: One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV)"
11240097|NCT02476032|EG001|Reported Event|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied oxalate: Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
11363738|NCT01629329|OG001|Outcome|Prochlorperazine 10mg|"Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills~Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills."
11363739|NCT01629329|EG000|Reported Event|Aspirin, Acetaminophen, Caffeine Pills|"Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline.~Aspirin, Acetaminophen, Caffeine pills: One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV)"
11363740|NCT01629329|EG001|Reported Event|Prochlorperazine 10mg|"Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills~Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills."
11363741|NCT01627899|BG000|Baseline|OneTouch VerioIQ BGMS|Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ
11363742|NCT01627899|FG000|Participant Flow|OneTouch VerioIQ BGMS|Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ
11363743|NCT01627899|OG000|Outcome|OneTouch VerioIQ BGMS|Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ
11363744|NCT01627899|EG000|Reported Event|OneTouch VerioIQ BGMS|Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ
11363745|NCT01632020|BG000|Baseline|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
11363746|NCT01632020|BG001|Baseline|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
11363747|NCT01632020|BG002|Baseline|Total|Total of all reporting groups
11363748|NCT01632020|FG000|Participant Flow|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
11363749|NCT01632020|FG001|Participant Flow|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
11363750|NCT01632020|OG000|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
11363751|NCT01632020|OG001|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
11363752|NCT01632020|EG000|Reported Event|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
11363753|NCT01632020|EG001|Reported Event|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
11363754|NCT01602471|BG000|Baseline|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
11363755|NCT01602471|FG000|Participant Flow|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
11363756|NCT01602471|OG000|Outcome|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
11363757|NCT01602471|EG000|Reported Event|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
11363758|NCT01619800|BG000|Baseline|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
11363759|NCT01619800|BG001|Baseline|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
11363760|NCT01619800|BG002|Baseline|Total|Total of all reporting groups
10962716|NCT00868218|FG003|Participant Flow|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11363761|NCT01619800|FG000|Participant Flow|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
11363762|NCT01619800|FG001|Participant Flow|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
11363763|NCT01619800|OG000|Outcome|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
11363764|NCT01619800|OG001|Outcome|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
11363765|NCT01619800|EG000|Reported Event|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
11363766|NCT01619800|EG001|Reported Event|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
11363767|NCT01608906|BG000|Baseline|All Participants|"Treatment: titrated to a PTT of 40-45. low dose intravenous heparin (LDIVH): The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days.~Control: Standard of Care."
11363768|NCT01608906|FG000|Participant Flow|All Participants|"Treatment: titrated to a PTT of 40-45. low dose intravenous heparin (LDIVH): The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days.~Control: Standard of Care."
11363769|NCT01608906|OG000|Outcome|Continuous Low Dose Intravenous Heparin Infusion|"titrated to a PTT of 40-45~low dose intravenous heparin (LDIVH): The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days."
11363770|NCT01608906|OG001|Outcome|Subcutanous Heparin 5000 Units 3 Times/Day|"standard of care~Heparin: 5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days"
11363771|NCT01608906|EG000|Reported Event|All Participants|"Treatment: titrated to a PTT of 40-45. low dose intravenous heparin (LDIVH): The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days.~Control: Standard of Care."
11363772|NCT01621737|BG000|Baseline|All Participants|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
11363773|NCT01621737|FG000|Participant Flow|All Participants|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
11363774|NCT01621737|OG000|Outcome|All Participants|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
11363775|NCT01621737|EG000|Reported Event|All Participants|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
11363776|NCT01614067|BG000|Baseline|Delayed Start|"Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.~Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist"
11363777|NCT01614067|BG001|Baseline|Conventional Start|"Ovarian stimulation with standard antagonist protocols (no delay).~Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist"
11363778|NCT01614067|BG002|Baseline|Total|Total of all reporting groups
11363779|NCT01614067|FG000|Participant Flow|Delayed Start|"Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.~Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist"
11363780|NCT01614067|FG001|Participant Flow|Conventional Start|"Ovarian stimulation with standard antagonist protocols (no delay).~Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist"
10962717|NCT00868218|OG000|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
10962718|NCT00868218|OG001|Outcome|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
10962719|NCT00868218|OG002|Outcome|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11363781|NCT01614067|OG000|Outcome|Delayed Start|"Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.~Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist"
11363782|NCT01614067|OG001|Outcome|Conventional Start|"Ovarian stimulation with standard antagonist protocols (no delay).~Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist"
11363783|NCT01614067|EG000|Reported Event|Delayed Start|"Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.~Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist"
11363784|NCT01614067|EG001|Reported Event|Conventional Start|"Ovarian stimulation with standard antagonist protocols (no delay).~Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist"
11363785|NCT01607320|BG000|Baseline|All Study Participants|Participants were randomized to receive one of the two following interventions, but the study was terminated and data will not be unblinded: 1) 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 with Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal; or 2) 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 with Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
11363786|NCT01607320|FG000|Participant Flow|Raloxifene|"3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7~Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal"
11188947|NCT02116777|EG005|Reported Event|600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day|"Phase 1: Part A~Part A1: Patients with relapsed or refractory solid tumors and CNS tumors~Part A2: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET"
11363787|NCT01607320|FG001|Participant Flow|Clomiphene|"3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7~Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal"
11188948|NCT02116777|EG006|Reported Event|600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day|"Phase 2: Part B~Part B: Patients with relapsed or refractory Ewing sarcoma or Peripheral PNET (Phase 2)"
11188949|NCT02116803|BG000|Baseline|Dovitinib|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
11188950|NCT02116803|BG001|Baseline|Dovitinib + Fulvestrant|Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
11188951|NCT02116803|BG002|Baseline|Total|Total of all reporting groups
11188952|NCT02116803|FG000|Participant Flow|Dovitinib|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
11363788|NCT01607320|OG000|Outcome|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
11363789|NCT01607320|EG000|Reported Event|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
11363790|NCT01605019|BG000|Baseline|CoSeal Arm|"patient randomized to received Coseal during LVAD implantation~CoSeal: 3 - 8mls of Coseal"
11188953|NCT02116803|FG001|Participant Flow|Dovitinib + Fulvestrant|Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
11188954|NCT02116803|OG000|Outcome|Dovitinib|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
11188955|NCT02116803|OG001|Outcome|Dovitinib + Fulvestrant|Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
11188956|NCT02116803|EG000|Reported Event|Dovitinib|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
11188957|NCT02116803|EG001|Reported Event|Dovitinib+Fulvestrant|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
11188958|NCT02116972|BG000|Baseline|FX006 16 mg|"Single intra-articular injection~FX006: Single intra-articular injection"
11188959|NCT02116972|BG001|Baseline|FX006 32 mg|"Single intra-articular injection~FX006: Single intra-articular injection"
11188960|NCT02116972|BG002|Baseline|Normal Saline|"Single intra-articular injection~Normal saline: Single intra-articular injection"
11188961|NCT02116972|BG003|Baseline|Total|Total of all reporting groups
11188962|NCT02116972|FG000|Participant Flow|FX006 16 mg|102 subjects received FX006 16 mg a single 5 mL IA injection
11188963|NCT02116972|FG001|Participant Flow|FX006 32 mg|104 subjects received FX006 32 mg a single 5 mL IA injection
11188964|NCT02116972|FG002|Participant Flow|Placebo|100 subjects received normal saline as a single 5 mL IA injection
11188965|NCT02116972|OG000|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
11188966|NCT02116972|OG001|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
11188967|NCT02116972|OG000|Outcome|FX006 16 mg|FX006: Single 5 mL IA injection
11188968|NCT02116972|OG001|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
11188969|NCT02116972|OG002|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
11188970|NCT02116972|EG000|Reported Event|FX006 16 mg|Single 5 mL IA injection
11363791|NCT01605019|BG001|Baseline|BioGlue® Surgical Adhesive|"BioGlue® Surgical Adhesive or use of no sealant application~BioGlue® Surgical Adhesive: Total amount applied - 8 mls"
11363792|NCT01605019|BG002|Baseline|Total|Total of all reporting groups
11363793|NCT01605019|FG000|Participant Flow|CoSeal Arm|"patient randomized to received Coseal during LVAD implantation~CoSeal: 3 - 8mls of Coseal"
11363794|NCT01605019|FG001|Participant Flow|BioGlue® Surgical Adhesive|"BioGlue® Surgical Adhesive or use of no sealant application~BioGlue® Surgical Adhesive: Total amount applied - 8 mls"
11363795|NCT01605019|OG000|Outcome|CoSeal Arm|"patient randomized to received Coseal during LVAD implantation~CoSeal: 3 - 8mls of Coseal"
11188971|NCT02116972|EG001|Reported Event|FX006 32 mg|Single 5 mL IA injection
11188972|NCT02116972|EG002|Reported Event|Placebo|Single 5 mL IA injection
11188973|NCT02117024|BG000|Baseline|Viagenpumatucel-L Plus Metronomic Cyclophosphamide|"Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.~Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig~Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks"
11188974|NCT02117024|BG001|Baseline|Chemotherapy Alone|"Patients will be treated with a physician's choice regimen until progression.~Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:~Vinorelbine~Erlotinib~Gemcitabine~Paclitaxel~Docetaxel~Pemetrexed"
11188975|NCT02117024|BG002|Baseline|Total|Total of all reporting groups
11188976|NCT02117024|FG000|Participant Flow|Viagenpumatucel-L Plus Metronomic Cyclophosphamide|"Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.~Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig~Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks"
11188977|NCT02117024|FG001|Participant Flow|Chemotherapy Alone|"Patients will be treated with a physician's choice regimen until progression.~Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:~Vinorelbine~Erlotinib~Gemcitabine~Paclitaxel~Docetaxel~Pemetrexed"
11188978|NCT02117024|OG000|Outcome|Viagenpumatucel-L Plus Metronomic Cyclophosphamide|"Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.~Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig~Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks"
11188979|NCT02117024|OG001|Outcome|Chemotherapy Alone|"Patients will be treated with a physician's choice regimen until progression.~Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:~Vinorelbine~Erlotinib~Gemcitabine~Paclitaxel~Docetaxel~Pemetrexed"
11188980|NCT02117024|EG000|Reported Event|Viagenpumatucel-L Plus Metronomic Cyclophosphamide|"Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.~Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig~Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks"
11188981|NCT02117024|EG001|Reported Event|Chemotherapy Alone|"Patients will be treated with a physician's choice regimen until progression.~Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:~Vinorelbine~Erlotinib~Gemcitabine~Paclitaxel~Docetaxel~Pemetrexed"
11188982|NCT02117193|BG000|Baseline|All Study Participants|Received Alcohol intake + Normal Sleep Received Alcohol intake + Sleep Deprivation Received Placebo intake + Normal Sleep Received Placebo intake + Sleep Deprivation
11188983|NCT02117193|FG000|Participant Flow|All Study Participants|This is a cross-over study.
11188984|NCT02117193|OG000|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
11188985|NCT02117193|OG001|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
11188986|NCT02117193|OG002|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Normal sleep: One night of normal sleep (8h)"
11188987|NCT02117193|OG003|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
11188988|NCT02117193|OG000|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
11188989|NCT02117193|OG001|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation~Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
11188990|NCT02117193|OG000|Outcome|Alcohol Intake + Normal Sleep|1g/kg of alcohol (beer) combined with 8 hours of normal sleep
11188991|NCT02117193|OG001|Outcome|Alcohol Intake + Sleep Deprivation|1g/kg of alcohol (beer) combined with 8 hours of sleep deprivation
11188992|NCT02117193|OG002|Outcome|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
11188993|NCT02117193|OG003|Outcome|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
11363796|NCT01605019|OG001|Outcome|BioGlue® Surgical Adhesive|"BioGlue® Surgical Adhesive or use of no sealant application~BioGlue® Surgical Adhesive: Total amount applied - 8 mls"
11363797|NCT01605019|EG000|Reported Event|CoSeal Arm|"patient randomized to received Coseal during LVAD implantation~CoSeal: 3 - 8mls of Coseal"
11363798|NCT01605019|EG001|Reported Event|BioGlue® Surgical Adhesive|"BioGlue® Surgical Adhesive or use of no sealant application~BioGlue® Surgical Adhesive: Total amount applied - 8 mls"
11363799|NCT01609231|BG000|Baseline|Dalotuzumab + Irinotecan|Participants received irinotecan IV, 180 mg/m^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).
11363800|NCT01609231|BG001|Baseline|Cetuximab + Irinotecan|Participants received cetuximab IV, initial dose of 400 mg/m^2 and then 250 mg/m^2 IV weekly + irinotecan IV, 180 mg/m^2 once every two weeks, during ≥1 42-day treatment cycle(s).
11363801|NCT01609231|BG002|Baseline|Total|Total of all reporting groups
11363802|NCT01609231|FG000|Participant Flow|Dalotuzumab + Irinotecan|Participants received irinotecan intravenously (IV), 180 mg/m^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).
11363803|NCT01609231|FG001|Participant Flow|Cetuximab + Irinotecan|Participants received cetuximab IV, initial dose of 400 mg/m^2 and then 250 mg/m^2 IV weekly + irinotecan IV, 180 mg/m^2 once every two weeks, during ≥1 42-day treatment cycle(s).
11363804|NCT01609231|OG000|Outcome|Dalotuzumab + Irinotecan|Participants received irinotecan IV, 180 mg/m^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).
11363805|NCT01609231|OG001|Outcome|Cetuximab + Irinotecan|Participants received cetuximab IV, initial dose of 400 mg/m^2 and then 250 mg/m^2 IV weekly + irinotecan IV, 180 mg/m^2 once every two weeks, during ≥1 42-day treatment cycle(s).
11363806|NCT01609231|EG000|Reported Event|Dalotuzumab + Irinotecan|Participants received irinotecan IV, 180 mg/m^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).
11363807|NCT01609231|EG001|Reported Event|Cetuximab + Irinotecan|Participants received cetuximab IV, initial dose of 400 mg/m^2 and then 250 mg/m^2 IV weekly + irinotecan IV, 180 mg/m^2 once every two weeks, during ≥1 42-day treatment cycle(s).
11363808|NCT01602198|BG000|Baseline|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
11363809|NCT01602198|BG001|Baseline|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
11363810|NCT01602198|BG002|Baseline|Total|Total of all reporting groups
11363811|NCT01602198|FG000|Participant Flow|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
11363812|NCT01602198|FG001|Participant Flow|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
11363813|NCT01602198|OG000|Outcome|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
11363814|NCT01602198|OG001|Outcome|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
11363815|NCT01602198|EG000|Reported Event|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
11363816|NCT01602198|EG001|Reported Event|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
11363817|NCT01606150|BG000|Baseline|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
11363818|NCT01606150|BG001|Baseline|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
11363819|NCT01606150|BG002|Baseline|Total|Total of all reporting groups
11363820|NCT01606150|FG000|Participant Flow|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
11363821|NCT01606150|FG001|Participant Flow|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
11363822|NCT01606150|OG000|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
11363823|NCT01606150|OG001|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
11363824|NCT01606150|EG000|Reported Event|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
11363825|NCT01606150|EG001|Reported Event|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
11363826|NCT01603043|BG000|Baseline|AL-78898A|1 intravitreal injection per month for up to 12 months
11363827|NCT01603043|BG001|Baseline|Sham Injection|1 mock injection per month for 12 months
11363828|NCT01603043|BG002|Baseline|Total|Total of all reporting groups
11363829|NCT01603043|FG000|Participant Flow|AL-78898A|1 intravitreal injection per month for up to 12 months
11363830|NCT01603043|FG001|Participant Flow|Sham Injection|1 mock injection per month for 12 months
11363831|NCT01603043|OG000|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
11363832|NCT01603043|OG001|Outcome|Sham Injection|1 mock injection per month for 12 months
11363833|NCT01603043|EG000|Reported Event|AL-78898A|1 intravitreal injection per month for up to 12 months
11363834|NCT01603043|EG001|Reported Event|Sham Injection|1 mock injection per month for 12 months
11363835|NCT01605370|BG000|Baseline|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
11363836|NCT01605370|BG001|Baseline|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
11363837|NCT01605370|BG002|Baseline|Total|Total of all reporting groups
11363838|NCT01605370|FG000|Participant Flow|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
11363839|NCT01605370|FG001|Participant Flow|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
11363840|NCT01605370|OG000|Outcome|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
11363841|NCT01605370|OG001|Outcome|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
11363842|NCT01605370|EG000|Reported Event|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
11363843|NCT01605370|EG001|Reported Event|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
11363844|NCT01605617|BG000|Baseline|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo.
11363845|NCT01605617|BG001|Baseline|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate.
11363846|NCT01605617|BG002|Baseline|Total|Total of all reporting groups
11363847|NCT01605617|FG000|Participant Flow|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks), Washout (4 weeks), PTNS + placebo (12 weeks)
11363848|NCT01605617|FG001|Participant Flow|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo (12 weeks), washout (4 weeks), PTNS + 4mg of fesoterodine fumarate (12 weeks)
11363849|NCT01605617|OG000|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
11363850|NCT01605617|OG001|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
11363851|NCT01605617|EG000|Reported Event|While on PTNS + Fesoterodine Fumarate First|Participants were given PTNS + 4mg of fesoterodine fumarate (12 weeks)
11363852|NCT01605617|EG001|Reported Event|While on PTNS + Placebo First|Participants were given PTNS + placebo (12 weeks)
11363853|NCT01605617|EG002|Reported Event|While on PTNS + Placebo Second|Participants were to be given PTNS + placebo (12 weeks)
11363854|NCT01605617|EG003|Reported Event|While on PTNS + Fesoterodine Fumarate Second|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks)
11363855|NCT01606709|BG000|Baseline|GnRH Agonist Trigger|"Induction of oocyte maturation with GnRH agonist~GnRH agonist: GnRH agonist 1mg one dose"
11363856|NCT01606709|BG001|Baseline|hCG Trigger|"Induction of oocyte maturation with hCG~hCG: 5,000 IU one dose"
11363857|NCT01606709|BG002|Baseline|Total|Total of all reporting groups
11363858|NCT01606709|FG000|Participant Flow|GnRH Agonist Trigger|"Induction of oocyte maturation with GnRH agonist~GnRH agonist: GnRH agonist 1mg one dose"
11363859|NCT01606709|FG001|Participant Flow|hCG Trigger|"Induction of oocyte maturation with hCG~hCG: 5,000 IU one dose"
11363860|NCT01606709|OG000|Outcome|GnRH Agonist Trigger|"Induction of oocyte maturation with GnRH agonist~GnRH agonist: GnRH agonist 1mg one dose"
11363861|NCT01606709|OG001|Outcome|hCG Trigger|"Induction of oocyte maturation with hCG~hCG: 5,000 IU one dose"
11363862|NCT01606709|EG000|Reported Event|GnRH Agonist Trigger|"Induction of oocyte maturation with GnRH agonist~GnRH agonist: GnRH agonist 1mg one dose"
11363863|NCT01606709|EG001|Reported Event|hCG Trigger|"Induction of oocyte maturation with hCG~hCG: 5,000 IU one dose"
11363864|NCT01603121|BG000|Baseline|All Study Participants|Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart.
11363865|NCT01603121|FG000|Participant Flow|Lisofylline Subcutaneous First, Then Lisofylline Intravenous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
11363866|NCT01603121|FG001|Participant Flow|Lisofylline Intravenous First, Then Lisofylline Subcutaneous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
11363867|NCT01603121|OG000|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
11363868|NCT01603121|OG001|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
11363869|NCT01603121|EG000|Reported Event|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
11363870|NCT01603121|EG001|Reported Event|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
11363871|NCT01602016|BG000|Baseline|All Participants|
11363872|NCT01602016|FG000|Participant Flow|All Participants|
11363873|NCT01602016|OG000|Outcome|All Participants|
11363874|NCT01602016|OG000|Outcome|Phase I|Baseline Visit Phase 1: The screening portion of the CELF will be administered to the child to screen for language impairment. If a child is determined to be pre-verbal they will automatically qualify,If there is no language impairment, the subject will not be eligible. If language impairment is confirmed, the participant will immediately go on to the baseline visit of Phase 2.
11363875|NCT01602016|OG001|Outcome|Phase II: 12 Week Folinic Acid or Placebo Intervention|The child will be consented for Phase 2 (the RCT) and undergo a blood draw (up to 20mL) for metabolic and autoantibody testing. the child will undergo language and behavioral assessment while the parent will be interviewed for the Vineland and other questionnaires (ASQ, RBS-R, SRS, and ABC). Demographic information including; age, race, gender, and ethnicity will be collected. The research pharmacist will randomize the participant to either Intervention A or B (only the research pharmacist will know which intervention has the folinic acid). The research pharmacist will distribute the drug or placebo to the parent and instruct the parent of the proper administration of the intervention. This will be considered the 12 week randomly controlled clinical trial that is investigating the safety and efficacy of folinic acis interventions in ASD and will last for approximately 12 weeks. At the end of 12 weeks, the same assessments that were conducted at baseline will be readministered
11363876|NCT01602016|OG002|Outcome|Phase III: Open Label Extension of Folinic Acid|"If consent for Phase 3 is signed by parents with children who qualify for Phase 3, the research pharmacist will provide a 12 week supply of folinic acid to the parent. This arm will be offered to all clients that completed phase 2 of the trial. After consenting and 12 weeks of folinic acid dosing, the client will come back and complete the same protocol and be tested on the same measures used in phase II of the study. This will be a rolling stopping point so that new therapies can be started, if the parent/caregiver is so inclined~Folinic Acid: capsules of folinic acis will be provided. The target dose will be 1mg/kg/day in two divided doses (0.5mg/kg/dose; 25mg/day maximum) for two weeks followed by 2 mg/kg/day with a maximum dose of 50mg/day provided the lower dose is well tolerated, for 10 weeks."
11363877|NCT01602016|EG000|Reported Event|All Participants|
11363878|NCT01603394|BG000|Baseline|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
11363879|NCT01603394|FG000|Participant Flow|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
11188994|NCT02117193|OG001|Outcome|Sequence 2|"Alcohol intake + Sleep Deprivation~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
11188995|NCT02117193|OG002|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.~Normal sleep: One night of normal sleep (8h)"
11363880|NCT01603394|OG000|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
11363881|NCT01603394|EG000|Reported Event|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
11363882|NCT01592383|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11363883|NCT01592383|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11363884|NCT01592383|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11363885|NCT01592383|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
11363886|NCT01592383|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11363887|NCT01598025|BG000|Baseline|REGIMEN 1|"REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~total-body irradiation (TBI)~thiotepa~fludarabine phosphate~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
11363888|NCT01598025|BG001|Baseline|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~thiotepa~fludarabine phosphate~melphalan~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
11363889|NCT01598025|BG002|Baseline|Total|Total of all reporting groups
11363890|NCT01598025|FG000|Participant Flow|REGIMEN 1|"REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~total-body irradiation (TBI)~thiotepa~fludarabine phosphate~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
11363891|NCT01598025|FG001|Participant Flow|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~thiotepa~fludarabine phosphate~melphalan~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
11363892|NCT01598025|OG000|Outcome|REGIMEN 1|"REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~total-body irradiation (TBI)~thiotepa~fludarabine phosphate~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
11363893|NCT01598025|OG001|Outcome|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~thiotepa~fludarabine phosphate~melphalan~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
11363894|NCT01598025|EG000|Reported Event|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0."
11363895|NCT01587963|BG000|Baseline|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
11363896|NCT01587963|BG001|Baseline|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
11363897|NCT01587963|BG002|Baseline|Total|Total of all reporting groups
11363898|NCT01587963|FG000|Participant Flow|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
11363899|NCT01587963|FG001|Participant Flow|Placebo|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
11363900|NCT01587963|OG000|Outcome|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
11363901|NCT01587963|OG001|Outcome|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
11363902|NCT01587963|EG000|Reported Event|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
11363903|NCT01587963|EG001|Reported Event|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
11188996|NCT02117193|OG003|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
11188997|NCT02117193|EG000|Reported Event|Alcohol Intake + Normal Sleep|1 g/kg of etanol combined with 8 hours of normal sleep
11363904|NCT01591096|BG000|Baseline|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
11363905|NCT01591096|FG000|Participant Flow|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
11363906|NCT01591096|OG000|Outcome|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
11188998|NCT02117193|EG001|Reported Event|Alcohol Intake + Sleep Deprivation|1 g/kg of etanol combined with 8 hours of sleep deprivation
11188999|NCT02117193|EG002|Reported Event|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
11363907|NCT01591096|EG000|Reported Event|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
11363908|NCT01591954|BG000|Baseline|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
11363909|NCT01591954|FG000|Participant Flow|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
11363910|NCT01591954|OG000|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
11363911|NCT01591954|EG000|Reported Event|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
11363912|NCT01589926|BG000|Baseline|Bi-level Positive Airway Pressure|"BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.~Bi-level positive airway pressure device: BiPAP initiated for at least 16 hours per day for a minimum of 48hrs."
11363913|NCT01589926|BG001|Baseline|Sham CPAP|"Physiologic CPAP initiated for at least 16 hours per day for a minimum of 48hrs.~Sham CPAP: Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs."
11363914|NCT01589926|BG002|Baseline|Total|Total of all reporting groups
11363915|NCT01589926|FG000|Participant Flow|Bi-level Positive Airway Pressure|"BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.~Bi-level positive airway pressure device: BiPAP initiated for at least 16 hours per day for a minimum of 48hrs."
11363916|NCT01589926|FG001|Participant Flow|Sham CPAP|"Physiologic CPAP initiated for at least 16 hours per day for a minimum of 48hrs.~Sham CPAP: Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs."
11363917|NCT01589926|OG000|Outcome|Bi-level Positive Airway Pressure|"BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.~Bi-level positive airway pressure device: BiPAP initiated for at least 16 hours per day for a minimum of 48hrs."
11363918|NCT01589926|OG001|Outcome|Sham CPAP|"Physiologic CPAP initiated for at least 16 hours per day for a minimum of 48hrs.~Sham CPAP: Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs."
11363919|NCT01589926|EG000|Reported Event|Bi-level Positive Airway Pressure|"BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.~Bi-level positive airway pressure device: BiPAP initiated for at least 16 hours per day for a minimum of 48hrs."
11363920|NCT01589926|EG001|Reported Event|Sham CPAP|"Physiologic CPAP initiated for at least 16 hours per day for a minimum of 48hrs.~Sham CPAP: Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs."
11363921|NCT01576575|BG000|Baseline|Healthy Volunteers|"Subjects will be studied during a maximum of seven occasions.~Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.~Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)~Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine~Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine~Sessions 6&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine"
11363922|NCT01576575|FG000|Participant Flow|Healthy Volunteers|Healthy males and non-pregnant females
11363923|NCT01576575|OG000|Outcome|Control (no Pretreatment)|Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
11363924|NCT01576575|OG001|Outcome|Rifampin|Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
11363925|NCT01576575|OG002|Outcome|Grapefruit Juice|Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
11363926|NCT01576575|OG003|Outcome|Ketoconazole|Sessions 6&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
11363927|NCT01576575|EG000|Reported Event|Control (no Pretreatment)|Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
11363928|NCT01576575|EG001|Reported Event|Liver and Gut CYP3A Induction|Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
11363929|NCT01576575|EG002|Reported Event|Gut Only CYP3A Inhibition|Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
11363930|NCT01576575|EG003|Reported Event|Liver and Gut CYP3A Inhibition|Sessions 6&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
11363931|NCT01590394|BG000|Baseline|Pancreatic Cancer Patients|A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
11363932|NCT01590394|FG000|Participant Flow|Pancreatic Cancer Patients|A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
11363933|NCT01590394|OG000|Outcome|Pancreatic Cancer Patients|A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
11363934|NCT01590394|EG000|Reported Event|Pancreatic Cancer Patients|A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
11363935|NCT01577628|BG000|Baseline|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
11363936|NCT01577628|BG001|Baseline|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
11363937|NCT01577628|BG002|Baseline|Total|Total of all reporting groups
11363938|NCT01577628|FG000|Participant Flow|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
11363939|NCT01577628|FG001|Participant Flow|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
11363940|NCT01577628|FG002|Participant Flow|Screen Only|Subject was not randomized to either treatment prior to study termination.
11363941|NCT01577628|OG000|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
11363942|NCT01577628|OG001|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
11363943|NCT01577628|EG000|Reported Event|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
11363944|NCT01577628|EG001|Reported Event|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
11363945|NCT01582100|BG000|Baseline|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
11363946|NCT01582100|FG000|Participant Flow|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
11363947|NCT01582100|OG000|Outcome|Single Arm Subjects With GERD/Nausea|This is a single arm study measuring the incidence and severity of nausea with or without vomiting in patients with GERD before and after treatment with Reletex
11363948|NCT01582100|EG000|Reported Event|Wrist Discomfort|subject did not like the feel of the device on wrist
11363949|NCT01583647|BG000|Baseline|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
11363950|NCT01583647|FG000|Participant Flow|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
11363951|NCT01583647|FG001|Participant Flow|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
11363952|NCT01583647|OG000|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
11363953|NCT01583647|OG001|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
11363954|NCT01583647|EG000|Reported Event|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
11363955|NCT01583647|EG001|Reported Event|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
11363956|NCT01575028|BG000|Baseline|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
11363957|NCT01575028|BG001|Baseline|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
11363958|NCT01575028|BG002|Baseline|Total|Total of all reporting groups
11363959|NCT01575028|FG000|Participant Flow|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
11363960|NCT01575028|FG001|Participant Flow|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
11363961|NCT01575028|OG000|Outcome|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
11363962|NCT01575028|OG001|Outcome|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
11363963|NCT01575028|EG000|Reported Event|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
11363964|NCT01575028|EG001|Reported Event|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
11363965|NCT01578785|BG000|Baseline|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
11363966|NCT01578785|BG001|Baseline|GA 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
11363967|NCT01578785|BG002|Baseline|Total|Total of all reporting groups
11363968|NCT01578785|FG000|Participant Flow|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
11363969|NCT01578785|FG001|Participant Flow|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
11189000|NCT02117193|EG003|Reported Event|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
11363970|NCT01578785|OG000|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
11363971|NCT01578785|OG001|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
11363972|NCT01578785|EG000|Reported Event|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
11363973|NCT01578785|EG001|Reported Event|Ga 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
11363974|NCT01576549|BG000|Baseline|LY2127399|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
11363975|NCT01576549|FG000|Participant Flow|LY2127399|"Participants received 240 milligrams (mg) LY2127399 administered subcutaneously (SC) (2 SC injections of 120 mg) as a loading dose on Day 1.~Follow-up visits occurred up to 24 weeks after the final injection of study drug."
11363976|NCT01576549|OG000|Outcome|LY2127399|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
11363977|NCT01576549|EG000|Reported Event|LY2127399 - Treatment Period|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
11363978|NCT01576549|EG001|Reported Event|LY2127399 - Follow-up Period|"Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.~Participants then discontinued dosing as a result of study closure, but completed the Post-Treatment Follow-Up Period for up to 24 weeks after the final injection of study drug."
11363979|NCT01570634|BG000|Baseline|Open Label CASAD|Treatment with CASAD for 14 days
11363980|NCT01570634|FG000|Participant Flow|Open Label CASAD|Treatment with Calcium Aluminosilicate Anti-Diarrheal (CASAD) for 14 days
11363981|NCT01570634|OG000|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
11363982|NCT01570634|EG000|Reported Event|Open Label CASAD|Treatment with CASAD for 14 days
11363983|NCT01566370|BG000|Baseline|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
11363984|NCT01566370|BG001|Baseline|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
11363985|NCT01566370|BG002|Baseline|Total|Total of all reporting groups
11363986|NCT01566370|FG000|Participant Flow|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
11363987|NCT01566370|FG001|Participant Flow|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
10962720|NCT00868218|OG003|Outcome|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11363988|NCT01566370|OG000|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
11363989|NCT01566370|OG001|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
11363990|NCT01566370|EG000|Reported Event|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
11363991|NCT01566370|EG001|Reported Event|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
11363992|NCT01561989|BG000|Baseline|Arm I (400 IU Cholecalciferol and Vaccine Therapy)|"Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.~cholecalciferol: Given PO~questionnaire administration: Ancillary studies~trivalent influenza vaccine: Given IM"
11363993|NCT01561989|BG001|Baseline|Arm II (4,000 IU Cholecalciferol and Vaccine Therapy)|"Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.~cholecalciferol: Given PO~questionnaire administration: Ancillary studies~trivalent influenza vaccine: Given IM"
11363994|NCT01561989|BG002|Baseline|Total|Total of all reporting groups
11363995|NCT01561989|FG000|Participant Flow|Arm I|"Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.~Unable to meet accrual objective. Arm closed with study termination."
11363996|NCT01561989|FG001|Participant Flow|Arm II|"Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.~Unable to meet accrual objective. Arm closed with study termination."
11363997|NCT01561989|OG000|Outcome|Arm I (400 IU Cholecalciferol and Vaccine Therapy)|"Patients receive low-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.~cholecalciferol: Given PO~questionnaire administration: Ancillary studies~trivalent influenza vaccine: Given IM"
11363998|NCT01561989|OG001|Outcome|Arm II (4,000 IU Cholecalciferol and Vaccine Therapy)|"Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the seasonal (2012-2013) trivalent influenza vaccine IM.~cholecalciferol: Given PO~questionnaire administration: Ancillary studies~trivalent influenza vaccine: Given IM"
11363999|NCT01561989|EG000|Reported Event|Cholecalciferal + Flu Vaccine|unable to meet accrual objective. study closed prior to delivery of any intervention. No analyses or followup.
11364000|NCT01561989|EG001|Reported Event|Flu Vaccine Alone|unable to meet accrual objective. study closed prior to delivery of intervention. No analyses or followup.
11364001|NCT01564732|BG000|Baseline|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
11364002|NCT01564732|BG001|Baseline|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
11364003|NCT01564732|BG002|Baseline|Total|Total of all reporting groups
11364004|NCT01564732|FG000|Participant Flow|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
11364005|NCT01564732|FG001|Participant Flow|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
11364006|NCT01564732|OG000|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
11364007|NCT01564732|OG001|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
11364008|NCT01564732|EG000|Reported Event|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
11364009|NCT01564732|EG001|Reported Event|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
11364010|NCT01560507|BG000|Baseline|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
11364011|NCT01560507|BG001|Baseline|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
11364012|NCT01560507|BG002|Baseline|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
11364013|NCT01560507|BG003|Baseline|Total|Total of all reporting groups
11364014|NCT01560507|FG000|Participant Flow|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
11364015|NCT01560507|FG001|Participant Flow|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
11364016|NCT01560507|FG002|Participant Flow|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
10962721|NCT00868218|OG000|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
10962722|NCT00868218|OG001|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
11364017|NCT01560507|OG000|Outcome|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
11364018|NCT01560507|OG001|Outcome|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
11364019|NCT01560507|OG002|Outcome|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
11364020|NCT01560507|OG000|Outcome|Varenicline (Chantix)|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.~varenicline (Chantix): For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
11364021|NCT01560507|OG001|Outcome|Nicotine Patches|"This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.~nicotine patches: 21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks."
11364022|NCT01560507|OG002|Outcome|Bupropion (Zyban) and Nicotine Patches|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.~bupropion (Zyban) & nicotine patches: After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
11364023|NCT01560507|EG000|Reported Event|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
11364024|NCT01560507|EG001|Reported Event|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
11364025|NCT01560507|EG002|Reported Event|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
11364026|NCT01557881|BG000|Baseline|Diagnostic (PET/MRI)|"After undergoing standard PET/CT, patients undergo PET/MRI.~magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status."
11364027|NCT01557881|FG000|Participant Flow|Diagnostic (PET/MRI)|"After undergoing standard PET/CT, patients undergo PET/MRI.~magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status."
11364028|NCT01557881|OG000|Outcome|Diagnostic (PET/MRI)|"After undergoing standard PET/CT, patients undergo PET/MRI.~magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status."
11364029|NCT01557881|EG000|Reported Event|Diagnostic (PET/MRI)|"After undergoing standard PET/CT, patients undergo PET/MRI.~magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status."
11364030|NCT01555489|BG000|Baseline|Ascorbic Acid, Gemcitabine & Erlotinib|"Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer~Ascorbic Acid: 3x per week"
11364031|NCT01555489|FG000|Participant Flow|Ascorbic Acid, Gemcitabine & Erlotinib|"Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer~Ascorbic Acid: 3x per week"
11364032|NCT01555489|OG000|Outcome|Ascorbic Acid, Gemcitabine & Erlotinib|"Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer~Ascorbic Acid: 3x per week"
11364033|NCT01555489|EG000|Reported Event|Ascorbic Acid, Gemcitabine & Erlotinib|"Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer~Ascorbic Acid: 3x per week"
11364034|NCT01549977|BG000|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
11364035|NCT01549977|BG001|Baseline|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
11364036|NCT01549977|BG002|Baseline|Total|Total of all reporting groups
11364037|NCT01549977|FG000|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
11364038|NCT01549977|FG001|Participant Flow|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
11364039|NCT01549977|OG000|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
11364040|NCT01549977|OG001|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
11364041|NCT01549977|EG000|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
11364042|NCT01549977|EG001|Reported Event|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
11364043|NCT01558492|BG000|Baseline|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
11364044|NCT01558492|FG000|Participant Flow|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
11364045|NCT01558492|OG000|Outcome|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
11364046|NCT01558492|EG000|Reported Event|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
11364047|NCT01550562|BG000|Baseline|Randomized|Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2).
11364048|NCT01550562|FG000|Participant Flow|Randomized|Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2).
11364049|NCT01550562|OG000|Outcome|Randomized|Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2).
11364050|NCT01550562|EG000|Reported Event|Randomized|Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2).
11364051|NCT01561495|BG000|Baseline|All Study Participants|All study participants received proton radiotherapy.
11364052|NCT01561495|FG000|Participant Flow|All Study Participants|All study participants received proton radiotherapy.
11364053|NCT01561495|OG000|Outcome|All Participants|"Proton Radiotherapy~Proton Therapy"
11364054|NCT01561495|EG000|Reported Event|All Study Participants|All study participants received proton radiotherapy.
11364055|NCT01555073|BG000|Baseline|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
11364056|NCT01555073|BG001|Baseline|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
11364057|NCT01555073|BG002|Baseline|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
11364058|NCT01555073|BG003|Baseline|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
11364059|NCT01555073|BG004|Baseline|Total|Total of all reporting groups
11364060|NCT01555073|FG000|Participant Flow|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
11364061|NCT01555073|FG001|Participant Flow|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
11364062|NCT01555073|FG002|Participant Flow|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
11364063|NCT01555073|FG003|Participant Flow|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
11364064|NCT01555073|OG000|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
11364065|NCT01555073|OG001|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
11364066|NCT01555073|OG002|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
11364067|NCT01555073|OG003|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
11364068|NCT01555073|EG000|Reported Event|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
11364069|NCT01555073|EG001|Reported Event|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
11364070|NCT01555073|EG002|Reported Event|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
11364071|NCT01555073|EG003|Reported Event|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
11364072|NCT01551082|BG000|Baseline|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
11364073|NCT01551082|FG000|Participant Flow|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
11364074|NCT01551082|OG000|Outcome|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
11364075|NCT01551082|EG000|Reported Event|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
11364076|NCT01556009|BG000|Baseline|Drug (Vismodegib)|"Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.~Vismodegib: 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months."
11364077|NCT01556009|BG001|Baseline|Aminolevulinic Acid %20 Topical Solution|"Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.~Aminolevulinic acid %20 topical solution: 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours."
11364078|NCT01556009|BG002|Baseline|Total|Total of all reporting groups
11364079|NCT01556009|FG000|Participant Flow|Drug (Vismodegib)|"Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.~Vismodegib: 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months."
11364080|NCT01556009|FG001|Participant Flow|Aminolevulinic Acid %20 Topical Solution|"Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.~Aminolevulinic acid %20 topical solution: 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours."
11364081|NCT01556009|OG000|Outcome|Drug (Vismodegib)|"Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.~Vismodegib: 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months."
11364082|NCT01556009|OG001|Outcome|Aminolevulinic Acid %20 Topical Solution|"Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.~Aminolevulinic acid %20 topical solution: 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours."
11364083|NCT01556009|EG000|Reported Event|Drug (Vismodegib)|"Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.~Vismodegib: 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months."
11364084|NCT01556009|EG001|Reported Event|Aminolevulinic Acid %20 Topical Solution|"Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.~Aminolevulinic acid %20 topical solution: 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours."
10962723|NCT00868218|OG002|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
11364085|NCT01550510|BG000|Baseline|Ascorbic Acid+Irinotecan|"Ascorbic Acid (50-100g, 3x weekly)~Ascorbic Acid: 3x a week for 9 weeks"
11364086|NCT01550510|BG001|Baseline|Standard of Care (Irinotecan Alone)|350mg/m2 once a week every 3 weeks
11364087|NCT01550510|BG002|Baseline|Total|Total of all reporting groups
11364088|NCT01550510|FG000|Participant Flow|Ascorbic Acid|"Ascorbic Acid (50-100g, 3x weekly)~Ascorbic Acid: 3x a week for 9 weeks"
11364089|NCT01550510|FG001|Participant Flow|Standard of Care (Irinotecan Alone)|350mg/m2 once a week every 3 weeks
11364090|NCT01550510|OG000|Outcome|Ascorbic Acid+Irinotecan|"Ascorbic Acid (50-100g, 3x weekly)~Ascorbic Acid: 3x a week for 9 weeks"
11364091|NCT01550510|OG001|Outcome|Standard of Care (Irinotecan Alone)|350mg/m2 once a week every 3 weeks
11364092|NCT01550510|OG000|Outcome|Ascorbic Acid|"Ascorbic Acid (50-100g, 3x weekly)~Ascorbic Acid: 3x a week for 9 weeks"
11364093|NCT01550510|EG000|Reported Event|Ascorbic Acid+Irinotecan|"Ascorbic Acid (50-100g, 3x weekly)~Ascorbic Acid: 3x a week for 9 weeks"
11364094|NCT01550510|EG001|Reported Event|Standard of Care (Irinotecan Alone)|350mg/m2 once a week every 3 weeks
11364095|NCT01541397|BG000|Baseline|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
11364096|NCT01541397|BG001|Baseline|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
11364097|NCT01541397|BG002|Baseline|Total|Total of all reporting groups
11364098|NCT01541397|FG000|Participant Flow|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
11364099|NCT01541397|FG001|Participant Flow|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
11364100|NCT01541397|OG000|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
11364101|NCT01541397|OG001|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
11364102|NCT01541397|EG000|Reported Event|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
11364103|NCT01541397|EG001|Reported Event|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
11364104|NCT01546207|BG000|Baseline|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
11364105|NCT01546207|FG000|Participant Flow|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
11364106|NCT01546207|OG000|Outcome|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
11364107|NCT01546207|EG000|Reported Event|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
11364108|NCT01553240|BG000|Baseline|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
11364109|NCT01553240|FG000|Participant Flow|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
11364110|NCT01553240|OG000|Outcome|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
11364111|NCT01553240|EG000|Reported Event|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
11364112|NCT01547728|BG000|Baseline|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
11364113|NCT01547728|FG000|Participant Flow|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
11364114|NCT01547728|OG000|Outcome|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
11364115|NCT01547728|EG000|Reported Event|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
11364116|NCT01548651|BG000|Baseline|Placebo|Placebo: Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma levels of inflammatory markers and CRP, ICAM, VCAM, plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 month treatment period.
11364117|NCT01548651|BG001|Baseline|Saxagliptin|"Saxagliptin 5 mg orally daily for 6 months~Saxagliptin: Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, and plasma levels of inflammatory markers, plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11240098|NCT02476032|EG002|Reported Event|Prof Applied Placebo|"Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied placebo: Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional."
11364118|NCT01548651|BG002|Baseline|Total|Total of all reporting groups
11364119|NCT01548651|FG000|Participant Flow|Placebo|Placebo: Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma levels of inflammatory markers and CRP, ICAM, VCAM, plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 month treatment period.
11364120|NCT01548651|FG001|Participant Flow|Saxagliptin|"Saxagliptin 5 mg orally daily for 6 months~Saxagliptin: Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, and plasma levels of inflammatory markers, plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
11364121|NCT01548651|OG000|Outcome|Placebo|Placebo: Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma levels of inflammatory markers and CRP, ICAM, VCAM, plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 month treatment period.
11364122|NCT01548651|OG001|Outcome|Saxagliptin|"Saxagliptin 5 mg orally daily for 6 months~Saxagliptin: Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma levels of inflammatory markers and C Reactive Protein (CRP), Intracellular Adhesion Molecule (ICAM), vascular cell adhesion molecule (VCAM), plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left"
11364123|NCT01548651|EG000|Reported Event|Placebo|Placebo: Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma levels of inflammatory markers and CRP, ICAM, VCAM, plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 month treatment period.
11364124|NCT01548651|EG001|Reported Event|Saxagliptin|"Saxagliptin 5 mg orally daily for 6 months~Saxagliptin: Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma levels of inflammatory markersplasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left"
11364125|NCT01545648|BG000|Baseline|Treatment|Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.
11364126|NCT01545648|FG000|Participant Flow|Treatment|Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.
11364127|NCT01545648|OG000|Outcome|Treatment|Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.
11364128|NCT01545648|EG000|Reported Event|Treatment|Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.
11364129|NCT01546883|BG000|Baseline|Dabigatran|Dabigatran
11364130|NCT01546883|FG000|Participant Flow|Dabigatran|"Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant~Dabigatran etexilate (Pradaxa): 150mg bid or 75mg bid for a period of one year"
11364131|NCT01546883|OG000|Outcome|Dabigatran|Dabigatran
11364132|NCT01546883|EG000|Reported Event|Dabigatran|Patients taking Dabigatran
11364133|NCT01545518|BG000|Baseline|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
11364134|NCT01545518|FG000|Participant Flow|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
11364135|NCT01545518|OG000|Outcome|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
11364136|NCT01545518|EG000|Reported Event|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover~No AE's."
11364137|NCT01536015|BG000|Baseline|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
11364138|NCT01536015|BG001|Baseline|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
11364139|NCT01536015|BG002|Baseline|Total|Total of all reporting groups
11364140|NCT01536015|FG000|Participant Flow|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
11364141|NCT01536015|FG001|Participant Flow|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
11364142|NCT01536015|OG000|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
11364143|NCT01536015|OG001|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
11364144|NCT01536015|EG000|Reported Event|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
11364145|NCT01536015|EG001|Reported Event|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
11364146|NCT01539590|BG000|Baseline|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
11364147|NCT01539590|BG001|Baseline|Placebo|Normal saline. Daily intravenous administration for four (4) days.
11364148|NCT01539590|BG002|Baseline|Total|Total of all reporting groups
11364149|NCT01539590|FG000|Participant Flow|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days ; 10 to 12 minutes; small molecule mimetic of hepatocyte growth factor
11364150|NCT01539590|FG001|Participant Flow|Placebo; 4 Daily Doses|Placebo: Normal saline; Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
11364151|NCT01539590|OG000|Outcome|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
11364152|NCT01539590|OG001|Outcome|Placebo, 4 Daily Doses|Normal saline. Daily intravenous administration for four (4) days.
11364153|NCT01539590|EG000|Reported Event|BB3 Small Molecule Mimetic of Hepatocyte Growth Factor|"small molecule mimetic of hepatocyte growth factor/scatter factor~BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days"
11364154|NCT01539590|EG001|Reported Event|Placebo|"Normal saline~Placebo: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight."
11364155|NCT01539811|BG000|Baseline|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
11364156|NCT01539811|BG001|Baseline|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
10849895|NCT00299130|OG000|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
10962724|NCT00868218|OG003|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
11364157|NCT01539811|BG002|Baseline|Total|Total of all reporting groups
10962725|NCT00868218|EG000|Reported Event|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11364158|NCT01539811|FG000|Participant Flow|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
11364159|NCT01539811|FG001|Participant Flow|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
11364160|NCT01539811|OG000|Outcome|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
11364161|NCT01539811|OG001|Outcome|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
11364162|NCT01539811|EG000|Reported Event|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
11364163|NCT01539811|EG001|Reported Event|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
11189001|NCT02117310|BG000|Baseline|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
11364164|NCT01534676|BG000|Baseline|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
11364165|NCT01534676|BG001|Baseline|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
11364166|NCT01534676|BG002|Baseline|Total|Total of all reporting groups
11364167|NCT01534676|FG000|Participant Flow|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
11364168|NCT01534676|FG001|Participant Flow|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
11364169|NCT01534676|OG000|Outcome|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
11364170|NCT01534676|OG001|Outcome|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
11364171|NCT01534676|EG000|Reported Event|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
11364172|NCT01534676|EG001|Reported Event|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
11364173|NCT01533753|BG000|Baseline|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
11364174|NCT01533753|BG001|Baseline|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
11364175|NCT01533753|BG002|Baseline|Total|Total of all reporting groups
11364176|NCT01533753|FG000|Participant Flow|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
11364177|NCT01533753|FG001|Participant Flow|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
11364178|NCT01533753|OG000|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
11189002|NCT02117310|FG000|Participant Flow|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
11189003|NCT02117310|OG000|Outcome|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
11189004|NCT02117310|EG000|Reported Event|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
11364179|NCT01533753|OG001|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
11364180|NCT01533753|EG000|Reported Event|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
11364181|NCT01533753|EG001|Reported Event|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
11364182|NCT01534143|BG000|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
11364183|NCT01534143|FG000|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
11364184|NCT01534143|OG000|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
11364185|NCT01534143|EG000|Reported Event|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
11364186|NCT01530880|BG000|Baseline|All Subjects|Includes subjects from both arms.
11364187|NCT01530880|FG000|Participant Flow|All Subjects|Includes subjects from both arms as this information is only available for all subjects and not per arm.
11364188|NCT01530880|OG000|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.~Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
11364189|NCT01530880|OG001|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).~Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
11364190|NCT01530880|EG000|Reported Event|All Subjects|Includes subjects from both arms as this information is only available for all subjects and not per arm.
11364191|NCT01530087|BG000|Baseline|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
11364192|NCT01530087|FG000|Participant Flow|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
11364193|NCT01530087|OG000|Outcome|Treatment|CASTLE Barrier: Prototype barrier used in place of previous two piece device
11364194|NCT01530087|OG000|Outcome|Treatment|"CASTLE Barrier~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
11364195|NCT01530087|EG000|Reported Event|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
11364196|NCT01527942|BG000|Baseline|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
11364197|NCT01527942|BG001|Baseline|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
11364198|NCT01527942|BG002|Baseline|Total|Total of all reporting groups
11364199|NCT01527942|FG000|Participant Flow|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
11189005|NCT02117349|BG000|Baseline|Raplixa Plus Gelfoam|Participants treated with Raplixa in addition to Gelfoam
11364200|NCT01527942|FG001|Participant Flow|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
11364201|NCT01527942|OG000|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
11364202|NCT01527942|OG001|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
11364203|NCT01527942|EG000|Reported Event|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
11364204|NCT01527942|EG001|Reported Event|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
11364205|NCT01521143|BG000|Baseline|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
11364206|NCT01521143|BG001|Baseline|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
11364207|NCT01521143|BG002|Baseline|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
11364208|NCT01521143|BG003|Baseline|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
11364209|NCT01521143|BG004|Baseline|Total|Total of all reporting groups
11364210|NCT01521143|FG000|Participant Flow|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
11364211|NCT01521143|FG001|Participant Flow|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
11364212|NCT01521143|FG002|Participant Flow|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
11364213|NCT01521143|FG003|Participant Flow|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
11364214|NCT01521143|OG000|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
11364215|NCT01521143|OG001|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
11364216|NCT01521143|OG002|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
11364217|NCT01521143|OG003|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
11364218|NCT01521143|EG000|Reported Event|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
11364219|NCT01521143|EG001|Reported Event|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
11364220|NCT01521143|EG002|Reported Event|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
11364221|NCT01521143|EG003|Reported Event|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
11364222|NCT01532635|BG000|Baseline|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
11364223|NCT01532635|FG000|Participant Flow|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
11364224|NCT01532635|OG000|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
11364225|NCT01532635|EG000|Reported Event|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
11364226|NCT01531387|BG000|Baseline|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
11364227|NCT01531387|BG001|Baseline|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
11364228|NCT01531387|BG002|Baseline|Total|Total of all reporting groups
11364229|NCT01531387|FG000|Participant Flow|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
11364230|NCT01531387|FG001|Participant Flow|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
11364231|NCT01531387|OG000|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
11364232|NCT01531387|OG001|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
11364233|NCT01531387|EG000|Reported Event|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
11364234|NCT01531387|EG001|Reported Event|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
11364235|NCT01532362|BG000|Baseline|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364236|NCT01532362|BG001|Baseline|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364237|NCT01532362|BG002|Baseline|Total|Total of all reporting groups
10962726|NCT00868218|EG001|Reported Event|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
10962727|NCT00868218|EG002|Reported Event|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11189006|NCT02117349|BG001|Baseline|Gelfoam Alone|Participants treated only with Gelfoam
11364238|NCT01532362|FG000|Participant Flow|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364239|NCT01532362|FG001|Participant Flow|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364240|NCT01532362|OG000|Outcome|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364241|NCT01532362|OG001|Outcome|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364242|NCT01532362|OG000|Outcome|Apricoxib|"As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.~Apricoxib: As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries."
11364243|NCT01532362|OG001|Outcome|No Drug Intervention|Apricoxib: As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364244|NCT01532362|EG000|Reported Event|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364245|NCT01532362|EG001|Reported Event|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
11364246|NCT01527292|BG000|Baseline|Control Group|"Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only~Stereotactic Radiation Therapy: SRT only"
11364247|NCT01527292|BG001|Baseline|Treatment Group|"Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure~SRT with Vertebral Augmentation Procedure: SRT with VAP"
11364248|NCT01527292|BG002|Baseline|Total|Total of all reporting groups
11364249|NCT01527292|FG000|Participant Flow|Control Group|"Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only~Stereotactic Radiation Therapy: SRT only"
11364250|NCT01527292|FG001|Participant Flow|Treatment Group|"Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure~SRT with Vertebral Augmentation Procedure: SRT with VAP"
11364251|NCT01527292|OG000|Outcome|Control Group|"Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only~Stereotactic Radiation Therapy: SRT only"
11364252|NCT01527292|OG001|Outcome|Treatment Group|"Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure~SRT with Vertebral Augmentation Procedure: SRT with VAP"
11364253|NCT01527292|EG000|Reported Event|Control Group|"Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only~Stereotactic Radiation Therapy: SRT only"
11364254|NCT01527292|EG001|Reported Event|Treatment Group|"Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure~SRT with Vertebral Augmentation Procedure: SRT with VAP"
11364255|NCT01525745|BG000|Baseline|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
11364256|NCT01525745|BG001|Baseline|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
11364257|NCT01525745|BG002|Baseline|Total|Total of all reporting groups
11364258|NCT01525745|FG000|Participant Flow|Radiosurgery/SBRT|"Radiosurgery/SBRT~Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
11364259|NCT01525745|FG001|Participant Flow|External Beam Radiation Therapy|"External Beam Radiation Therapy~External Beam Radiation Therapy: 10 consecutive days of standard radiation"
11364260|NCT01525745|OG000|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
11364261|NCT01525745|OG001|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
11364262|NCT01525745|OG000|Outcome|Radiosurgery/SBRT|"Radiosurgery/SBRT~Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
11364263|NCT01525745|OG001|Outcome|External Beam Radiation Therapy|"External Beam Radiation Therapy~External Beam Radiation Therapy: 10 consecutive days of standard radiation"
11364264|NCT01525745|EG000|Reported Event|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
11364265|NCT01525745|EG001|Reported Event|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
11364266|NCT01528696|BG000|Baseline|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
11364267|NCT01528696|BG001|Baseline|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
11364268|NCT01528696|BG002|Baseline|Total|Total of all reporting groups
11364269|NCT01528696|FG000|Participant Flow|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
11364270|NCT01528696|FG001|Participant Flow|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
11189007|NCT02117349|BG002|Baseline|Total|Total of all reporting groups
11364271|NCT01528696|OG000|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
11364272|NCT01528696|OG001|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
11364273|NCT01528696|EG000|Reported Event|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
11364274|NCT01528696|EG001|Reported Event|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
11364275|NCT01526408|BG000|Baseline|Placebo Arm|"Treatment with 3 months of placebo~Placebo: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months)."
11364276|NCT01526408|BG001|Baseline|Active Arm|"Treatment with 3 months of active drug~Famciclovir: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug)."
11364277|NCT01526408|BG002|Baseline|Total|Total of all reporting groups
11364278|NCT01526408|FG000|Participant Flow|Placebo Arm|"Treatment with 3 months of placebo~Placebo: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months)."
11189008|NCT02117349|FG000|Participant Flow|Raplixa Plus Gelfoam|Participants treated with Raplixa in addition to Gelfoam
11189009|NCT02117349|FG001|Participant Flow|Gelfoam Alone|Participants treated only with Gelfoam
11189010|NCT02117349|OG000|Outcome|Raplixa Plus Gelfoam|Participants treated with Raplixa in addition to Gelfoam
11364279|NCT01526408|FG001|Participant Flow|Active Arm|"Treatment with 3 months of active drug~Famciclovir: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug)."
11364280|NCT01526408|OG000|Outcome|Placebo Arm|"Treatment with 3 months of placebo~Placebo: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months)."
11364281|NCT01526408|OG001|Outcome|Active Arm|"Treatment with 3 months of active drug~Famciclovir: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug)."
11364282|NCT01526408|EG000|Reported Event|Placebo Arm|"Treatment with 3 months of placebo~Placebo: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months)."
11364283|NCT01526408|EG001|Reported Event|Active Arm|"Treatment with 3 months of active drug~Famciclovir: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug)."
11364284|NCT01528293|BG000|Baseline|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
10962728|NCT00868218|EG003|Reported Event|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
11189011|NCT02117349|OG001|Outcome|Gelfoam Alone|Participants treated only with Gelfoam
11189012|NCT02117349|EG000|Reported Event|Raplixa Plus Gelfoam|Participants treated with Raplixa in addition to Gelfoam
11189013|NCT02117349|EG001|Reported Event|Gelfoam Alone|Participants treated only with Gelfoam
11189014|NCT02117414|BG000|Baseline|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
11189015|NCT02117414|BG001|Baseline|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
11189016|NCT02117414|BG002|Baseline|Total|Total of all reporting groups
11189017|NCT02117414|FG000|Participant Flow|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
11189018|NCT02117414|FG001|Participant Flow|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
11189019|NCT02117414|OG000|Outcome|MRI Group|All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
11364285|NCT01528293|BG001|Baseline|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
11364286|NCT01528293|BG002|Baseline|Total|Total of all reporting groups
11364287|NCT01528293|FG000|Participant Flow|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
11364288|NCT01528293|FG001|Participant Flow|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
11364289|NCT01528293|OG000|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
11364290|NCT01528293|OG001|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
11377052|NCT00346164|OG003|Outcome|Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
11189020|NCT02117414|OG000|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
11189021|NCT02117414|OG001|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
11189022|NCT02117414|OG000|Outcome|Implanted Subjects|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.
11189023|NCT02117414|EG000|Reported Event|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
11189024|NCT02117414|EG001|Reported Event|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
11189025|NCT02117427|BG000|Baseline|Group A|18-25 IU/Kg/day
11189026|NCT02117427|BG001|Baseline|Group B|35-45 IU/Kg/day
11189027|NCT02117427|BG002|Baseline|Group C|55-65 IU/Kg/day
11189028|NCT02117427|BG003|Baseline|Total|Total of all reporting groups
11189029|NCT02117427|FG000|Participant Flow|Group A: 18-25 IU/Kg/Day|
11189030|NCT02117427|FG001|Participant Flow|Group B: 35-45 IU/Kg/Day|
11189031|NCT02117427|FG002|Participant Flow|Group C: 55-65 IU/Kg/Day|
11189032|NCT02117427|OG000|Outcome|All Subjects Enrolled|
11364291|NCT01528293|EG000|Reported Event|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
11364292|NCT01528293|EG001|Reported Event|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
11364293|NCT01525927|BG000|Baseline|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders."
11364294|NCT01525927|BG001|Baseline|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
11364295|NCT01525927|BG002|Baseline|Total|Total of all reporting groups
11364296|NCT01525927|FG000|Participant Flow|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
11364297|NCT01525927|OG000|Outcome|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
11364298|NCT01525927|OG000|Outcome|No Study Intervention or Data Collected- Zero (0) Participants|No study intervention or data collected- Zero (0) participants analyzed
11364299|NCT01525927|EG000|Reported Event|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders.~Zero (0) participants analyzed"
11364300|NCT01525927|EG001|Reported Event|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy.~Zero (0) participants analyzed"
11364301|NCT01520714|BG000|Baseline|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
11364302|NCT01520714|BG001|Baseline|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
11364303|NCT01520714|BG002|Baseline|Total|Total of all reporting groups
11364304|NCT01520714|FG000|Participant Flow|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
11364305|NCT01520714|FG001|Participant Flow|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
11377053|NCT00346164|OG000|Outcome|Arm D|Intermediate & High Risk; Neoadjuvant chemoradiotherapy
11377054|NCT00346164|OG000|Outcome|Non-metastatic|
11377055|NCT00346164|OG001|Outcome|Metastatic|
11377056|NCT00346164|OG000|Outcome|Histologic Grade 1|
10962729|NCT00868231|BG000|Baseline|Overall Study Population|All patients randomized into the crossover study
11364306|NCT01520714|OG000|Outcome|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
11364307|NCT01520714|OG001|Outcome|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
11364308|NCT01520714|EG000|Reported Event|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
11364309|NCT01520714|EG001|Reported Event|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
11364310|NCT01507233|BG000|Baseline|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
11189033|NCT02117427|EG000|Reported Event|Group A|18-25 IU/Kg/day
11189034|NCT02117427|EG001|Reported Event|Group B|35-45 IU/Kg/day
11189035|NCT02117427|EG002|Reported Event|Group C|55-65 IU/Kg/day
11364311|NCT01507233|BG001|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
11364312|NCT01507233|BG002|Baseline|Total|Total of all reporting groups
11364313|NCT01507233|FG000|Participant Flow|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
11364314|NCT01507233|FG001|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
11364315|NCT01507233|OG000|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
11364316|NCT01507233|OG001|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
11364317|NCT01507233|EG000|Reported Event|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
11377057|NCT00346164|OG001|Outcome|Histologic Grade 2|
11189036|NCT02117479|BG000|Baseline|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189037|NCT02117479|BG001|Baseline|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189038|NCT02117479|BG002|Baseline|Total|Total of all reporting groups
11189039|NCT02117479|FG000|Participant Flow|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189040|NCT02117479|FG001|Participant Flow|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189041|NCT02117479|OG000|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189042|NCT02117479|OG001|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11364318|NCT01507233|EG001|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
11364319|NCT01516034|BG000|Baseline|Treatment|Cupola tattoo removal treatment
11364320|NCT01516034|FG000|Participant Flow|Treatment|Cupola tattoo removal treatment
11364321|NCT01516034|OG000|Outcome|Treatment|Cupola tattoo removal treatment
11364322|NCT01516034|EG000|Reported Event|Treatment|Cupola tattoo removal treatment
11364323|NCT01500772|BG000|Baseline|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
11364324|NCT01500772|FG000|Participant Flow|Alisporivir|Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks.
11364325|NCT01500772|OG000|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
11364326|NCT01500772|EG000|Reported Event|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
11364327|NCT01517763|BG000|Baseline|Conventional CPAP|"Fisher & Paykel HC244™~Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake"
11364328|NCT01517763|BG001|Baseline|CPAP Without Humidification|"Fixed pressure ICON™ without ThermoSmart™~Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™"
11364329|NCT01517763|BG002|Baseline|APAP With All Technologies|"Auto ICON™ with SensAwake™ and ThermoSmart™~Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™"
11364330|NCT01517763|BG003|Baseline|Total|Total of all reporting groups
11364331|NCT01517763|FG000|Participant Flow|Conventional CPAP|"Fisher & Paykel HC244™~Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake"
11364332|NCT01517763|FG001|Participant Flow|CPAP Without Humidification|"Fixed pressure ICON™ without ThermoSmart™~Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™"
11364333|NCT01517763|FG002|Participant Flow|APAP With All Technologies|"Auto ICON™ with SensAwake™ and ThermoSmart™~Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™"
11364334|NCT01517763|OG000|Outcome|Conventional CPAP|"Fisher & Paykel HC244™~Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake"
11364335|NCT01517763|OG001|Outcome|CPAP Without Humidification|"Fixed pressure ICON™ without ThermoSmart™~Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™"
11364336|NCT01517763|OG002|Outcome|APAP With All Technologies|"Auto ICON™ with SensAwake™ and ThermoSmart™~Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™"
11364337|NCT01517763|EG000|Reported Event|Conventional CPAP|"Fisher & Paykel HC244™~Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake"
11364338|NCT01517763|EG001|Reported Event|CPAP Without Humidification|"Fixed pressure ICON™ without ThermoSmart™~Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™"
11364339|NCT01517763|EG002|Reported Event|APAP With All Technologies|"Auto ICON™ with SensAwake™ and ThermoSmart™~Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™"
11364340|NCT01507584|BG000|Baseline|ALL PARTICIPANTS|
11364341|NCT01507584|FG000|Participant Flow|ALL PARTICIPANTS|
11364342|NCT01507584|OG000|Outcome|ALL PARTICIPANTS|
11364343|NCT01507584|EG000|Reported Event|ALL PARTICIPANTS|
11364344|NCT01510756|BG000|Baseline|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
11364345|NCT01510756|FG000|Participant Flow|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
11364346|NCT01510756|OG000|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
11364347|NCT01510756|EG000|Reported Event|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
11364348|NCT01511081|BG000|Baseline|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
11364349|NCT01511081|BG001|Baseline|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
11364350|NCT01511081|BG002|Baseline|Total|Total of all reporting groups
11364351|NCT01511081|FG000|Participant Flow|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
11364352|NCT01511081|FG001|Participant Flow|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
11364353|NCT01511081|OG000|Outcome|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
11364354|NCT01511081|OG001|Outcome|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
11377058|NCT00346164|OG002|Outcome|Histologic Grade 3|
11364355|NCT01511081|EG000|Reported Event|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
11364356|NCT01511081|EG001|Reported Event|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
11364357|NCT01500109|BG000|Baseline|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
11364358|NCT01500109|BG001|Baseline|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
11364359|NCT01500109|BG002|Baseline|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
11364360|NCT01500109|BG003|Baseline|Total|Total of all reporting groups
11364361|NCT01500109|FG000|Participant Flow|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
11364362|NCT01500109|FG001|Participant Flow|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
11364363|NCT01500109|FG002|Participant Flow|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
11364364|NCT01500109|OG000|Outcome|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
11377059|NCT00346164|OG000|Outcome|Less Than Total Resection|
11377060|NCT00346164|OG001|Outcome|Negative Margins|
11377061|NCT00346164|OG002|Outcome|Positive Margins|
11364365|NCT01500109|OG001|Outcome|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
11364366|NCT01500109|OG002|Outcome|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
11364367|NCT01500109|EG000|Reported Event|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
11364368|NCT01500109|EG001|Reported Event|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
11364369|NCT01500109|EG002|Reported Event|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
11364370|NCT01509053|BG000|Baseline|All Participants|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
11364371|NCT01509053|FG000|Participant Flow|Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
11377062|NCT00346164|OG000|Outcome|All Patients|All patients
11377063|NCT00346164|OG000|Outcome|Histologic Grade 1 by Enrolling Institution|
11377064|NCT00346164|OG001|Outcome|Histologic Grade 2 by Enrolling Institution|
11377065|NCT00346164|OG002|Outcome|Histologic Grade 3 by Enrolling Institution|
11377066|NCT00346164|OG000|Outcome|Histologic Grade 1 by FNCLCC|
11189043|NCT02117479|EG000|Reported Event|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189044|NCT02117479|EG001|Reported Event|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11377067|NCT00346164|OG001|Outcome|Histologic Grade 2 by FNCLCC|
11377068|NCT00346164|OG002|Outcome|Histologic Grade 3 by FNCLCC|
11364372|NCT01509053|OG000|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
11364373|NCT01509053|OG001|Outcome|Standard of Care|Patients who received oral antipsychotic treatment as standard of care in clinical practice.
11364374|NCT01509053|OG000|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
11364375|NCT01509053|EG000|Reported Event|Oral Aripiprazole (Phase A)|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot.
11364376|NCT01509053|EG001|Reported Event|Aripiprazole IM Depot (Phase B)|In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
11364377|NCT01509053|EG002|Reported Event|Aripiprazole IM Depot (Phase C)|Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
11364378|NCT01495988|BG000|Baseline|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
11364379|NCT01495988|BG001|Baseline|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
11364380|NCT01495988|BG002|Baseline|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
11364381|NCT01495988|BG003|Baseline|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
11364382|NCT01495988|BG004|Baseline|Total|Total of all reporting groups
11364383|NCT01495988|FG000|Participant Flow|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
11364384|NCT01495988|FG001|Participant Flow|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
11364385|NCT01495988|FG002|Participant Flow|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
11364386|NCT01495988|FG003|Participant Flow|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
11189045|NCT02117544|BG000|Baseline|Overall|AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.
11364387|NCT01495988|OG000|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
11364388|NCT01495988|OG001|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
11364389|NCT01495988|OG002|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
11364390|NCT01495988|OG003|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
11364391|NCT01495988|EG000|Reported Event|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
11364392|NCT01495988|EG001|Reported Event|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
11364393|NCT01495988|EG002|Reported Event|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
11364394|NCT01495988|EG003|Reported Event|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
11364395|NCT01498991|BG000|Baseline|AMES Treatment|"The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.~AMES Treatment: The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg)."
11364396|NCT01498991|FG000|Participant Flow|AMES Treatment|"The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.~AMES Treatment: The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg)."
11364397|NCT01498991|OG000|Outcome|AMES Treatment|"The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.~AMES Treatment: The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg)."
11377069|NCT00346164|EG000|Reported Event|Arm A: No Adjuvant Treatment|"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery"
11189046|NCT02117544|FG000|Participant Flow|New MF, Then AOAMF|Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.
11189047|NCT02117544|FG001|Participant Flow|AOAMF, Then New MF|Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
11189048|NCT02117544|OG000|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
11364398|NCT01498991|EG000|Reported Event|AMES Treatment|"The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.~AMES Treatment: The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg)."
11364399|NCT01497171|BG000|Baseline|Elevate Mesh|Transvaginal mesh repair of anterior vaginal prolapse
11364400|NCT01497171|BG001|Baseline|Anterior Colporrhaphy|Traditional suture repair of anterior vaginal prolapse
11364401|NCT01497171|BG002|Baseline|Total|Total of all reporting groups
11364402|NCT01497171|FG000|Participant Flow|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
11364403|NCT01497171|FG001|Participant Flow|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
11189049|NCT02117544|OG001|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
11189050|NCT02117544|EG000|Reported Event|Pre-treatment|Includes all enrolled subjects/eyes prior to exposure to the investigational products
11189051|NCT02117544|EG001|Reported Event|New MF|Includes all subjects/eyes exposed to New MF
11364404|NCT01497171|OG000|Outcome|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
11364405|NCT01497171|OG001|Outcome|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
11364406|NCT01497171|EG000|Reported Event|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
11189052|NCT02117544|EG002|Reported Event|AOAMF|Includes all subjects/eyes exposed to AOAMF
11364407|NCT01497171|EG001|Reported Event|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
11189053|NCT02117570|BG000|Baseline|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189054|NCT02117570|BG001|Baseline|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189055|NCT02117570|BG002|Baseline|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189056|NCT02117570|BG003|Baseline|Total|Total of all reporting groups
11189057|NCT02117570|FG000|Participant Flow|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189058|NCT02117570|FG001|Participant Flow|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189059|NCT02117570|FG002|Participant Flow|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189060|NCT02117570|OG000|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11364408|NCT01483872|BG000|Baseline|All Participants|
11364409|NCT01483872|FG000|Participant Flow|NAC/Tigecycline/Heparin Combination Lock Solution|"A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter~NAC/Tigecycline/Heparin combination lock solution"
11364410|NCT01483872|FG001|Participant Flow|Standard Anticoagulant (Heparin or Citrate)|"Standard anticoagulant (heparin or citrate)~Standard anticoagulant (Heparin or Citrate)"
11364411|NCT01483872|OG000|Outcome|All Participants|Nine participants signed consent forms, only one randomized. Data was not analyzed.
11364412|NCT01483872|EG000|Reported Event|All Participants|Nine participants signed consent forms, only one randomized. Data was not analyzed.
11376273|NCT00980460|OG003|Outcome|High-risk Group (Regimen W)|"(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11377070|NCT00346164|EG001|Reported Event|Arm B: Low Risk; Adjuvant Radiotherapy|"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy"
11364413|NCT01487499|BG000|Baseline|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
11364414|NCT01487499|FG000|Participant Flow|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
11364415|NCT01487499|OG000|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
11364416|NCT01487499|EG000|Reported Event|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
11364417|NCT01478113|BG000|Baseline|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364418|NCT01478113|BG001|Baseline|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364419|NCT01478113|BG002|Baseline|Total|Total of all reporting groups
11364420|NCT01478113|FG000|Participant Flow|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364421|NCT01478113|FG001|Participant Flow|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364422|NCT01478113|OG000|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364423|NCT01478113|OG001|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364424|NCT01478113|OG000|Outcome|WBT + Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine/dextroamphetamine: The amphetamine/dextroamphetamine will be in a pill formulation. The dosage of the amphetamine/dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364425|NCT01478113|OG001|Outcome|WBT + Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364426|NCT01478113|EG000|Reported Event|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364427|NCT01478113|EG001|Reported Event|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
11364428|NCT01483209|BG000|Baseline|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
11364429|NCT01483209|FG000|Participant Flow|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
11364430|NCT01483209|OG000|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
11364431|NCT01483209|EG000|Reported Event|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
11364432|NCT01484314|BG000|Baseline|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
11364433|NCT01484314|FG000|Participant Flow|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
11189061|NCT02117570|OG001|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189062|NCT02117570|OG002|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189063|NCT02117570|EG000|Reported Event|Placebo (50-64 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189064|NCT02117570|EG001|Reported Event|Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189065|NCT02117570|EG002|Reported Event|Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189066|NCT02117570|EG003|Reported Event|Placebo (65-85 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189067|NCT02117570|EG004|Reported Event|Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11364434|NCT01484314|OG000|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
11364435|NCT01484314|EG000|Reported Event|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
11364436|NCT01482598|BG000|Baseline|Optimal Remote Care|"Patient follow up is performed through remote care, remote alerts on Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant.~Remote Care Follow up: Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed"
11364437|NCT01482598|BG001|Baseline|Optimal Standard Care|Patient standard in clinic visits are performed every 6 months.
11364438|NCT01482598|BG002|Baseline|Total|Total of all reporting groups
11364439|NCT01482598|FG000|Participant Flow|Optimal Remote Care|"Patient follow up is performed through remote care, remote alerts on CRT-D device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant.~Remote Care Follow up: Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed"
11364440|NCT01482598|FG001|Participant Flow|Optimal Standard Care|Patient standard in clinic visits are performed every 6 months.
11189068|NCT02117570|EG005|Reported Event|Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
11189069|NCT02117648|BG000|Baseline|Abemaciclib Then Abemaciclib + Clarithromycin|50 mg single oral dose of Abemaciclib was administered on Period 1 Day 1 and on Period 2 Day 5. Clarithromycin 500 mg orally twice daily for 12 days. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib Q12H on a 28-day cycle in a safety-extension phase until discontinuation criteria were met.
11189070|NCT02117648|FG000|Participant Flow|Abemaciclib Alone Then Abemaciclib + Clarithromycin|50 mg single oral dose of Abemaciclib was administered on Period 1 Day 1 and on Period 2 Day 5. Clarithromycin 500 milligram (mg) orally twice daily for 12 days. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib every 12 hours (Q12H) on a 28-day cycle in a safety-extension phase until discontinuation criteria were met.
11189071|NCT02117648|OG000|Outcome|Abemaciclib Period 1|50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1.
11189072|NCT02117648|OG001|Outcome|Abemaciclib + Clarithromycin Period 2|Starting on Period 2 Day 1, Clarithromycin 500 mg orally twice daily for 12 days. Single oral dose of Abemaciclib on Period 2 Day 5. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib.
11189073|NCT02117648|EG000|Reported Event|Abemaciclib|50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1.
11189074|NCT02117648|EG001|Reported Event|Clarithromycin|Clarithromycin 500 mg orally twice daily for 12 days
11189075|NCT02117648|EG002|Reported Event|Abemaciclib + Clarithromycin|Clarithromycin 500 mg orally twice daily for 12 days. Single oral dose of Abemaciclib on Period 2 Day 5 . Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib.
11189076|NCT02117648|EG003|Reported Event|Safety Extension Abemaciclib|After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib Q12H on a 28-day cycle in a safety-extension phase until discontinuation criteria were met.
11364441|NCT01482598|OG000|Outcome|Optimal Standard Care|Patient standard in clinic visits are performed every 6 months.
11364442|NCT01482598|OG001|Outcome|Remote Care|Patients perform a 6 and 18 (optional) months Remote Follow Up and 12 and 24 months in clinic visits
11364443|NCT01482598|EG000|Reported Event|Optimal Standard Care|Patient standard in clinic visits are performed every 6 months.
11364444|NCT01482598|EG001|Reported Event|Remote Care|Patients perform a 6 and 18 (optional) months Remote Follow Up and 12 and 24 months in clinic visits
11364445|NCT01479010|BG000|Baseline|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
11364446|NCT01479010|FG000|Participant Flow|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
11364447|NCT01479010|OG000|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
11364448|NCT01479010|EG000|Reported Event|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
11364449|NCT01482325|BG000|Baseline|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring~Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor"
11364450|NCT01482325|FG000|Participant Flow|Subjects Requiring Blood Pressure Monitoring|"St. Joseph's Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.~There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study's GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
11364451|NCT01482325|OG000|Outcome|Subjects Requiring Blood Pressure Monitoring|"St. Joseph's Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.~There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study's GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
11364452|NCT01482325|EG000|Reported Event|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring~Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor~At Site #001 - St. Joseph's Hospital, there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. There were no adverse events reported.~At Site #002 - Wisconsin Heart Hospital, there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study. There were no adverse events reported."
11364453|NCT01477177|BG000|Baseline|Polar Wand Treatment|"Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia~Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length."
11364454|NCT01477177|FG000|Participant Flow|Polar Wand Treatment|"Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia~Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length."
11364455|NCT01477177|OG000|Outcome|Polar Wand Treatment|"Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia~Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length."
11364456|NCT01477177|EG000|Reported Event|Polar Wand Treatment|"Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia~Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length."
11364457|NCT01473732|BG000|Baseline|Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)|Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year.
11364458|NCT01473732|BG001|Baseline|Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)|Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year.
11189077|NCT02117687|BG000|Baseline|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
11189078|NCT02117687|BG001|Baseline|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
11189079|NCT02117687|BG002|Baseline|Total|Total of all reporting groups
11189080|NCT02117687|FG000|Participant Flow|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
11364459|NCT01473732|BG002|Baseline|Total|Total of all reporting groups
11364460|NCT01473732|FG000|Participant Flow|Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)|Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year.
11364461|NCT01473732|FG001|Participant Flow|Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)|Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year.
11364462|NCT01473732|OG000|Outcome|Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)|Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year.
11364463|NCT01473732|OG001|Outcome|Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)|Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year.
11364464|NCT01473732|EG000|Reported Event|Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)|Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year.
11364465|NCT01473732|EG001|Reported Event|Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)|Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year.
11364466|NCT01472692|BG000|Baseline|Febuxostat|Febuxostat: 80mg PO daily for 8 weeks
11364467|NCT01472692|BG001|Baseline|Placebo|Febuxostat: 80mg PO daily for 8 weeks
11364468|NCT01472692|BG002|Baseline|Total|Total of all reporting groups
11364469|NCT01472692|FG000|Participant Flow|Febuxostat|Febuxostat: 80mg PO daily for 8 weeks
11364470|NCT01472692|FG001|Participant Flow|Placebo|Febuxostat: 80mg PO daily for 8 weeks
11364471|NCT01472692|OG000|Outcome|Febuxostat|Febuxostat: 80mg PO daily for 8 weeks
11364472|NCT01472692|OG001|Outcome|Placebo|Febuxostat: 80mg PO daily for 8 weeks
11364473|NCT01472692|EG000|Reported Event|Febuxostat|Febuxostat: 80mg PO daily for 8 weeks
11364474|NCT01472692|EG001|Reported Event|Placebo|Febuxostat: 80mg PO daily for 8 weeks
11364475|NCT01465230|BG000|Baseline|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
11364476|NCT01465230|FG000|Participant Flow|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
11364477|NCT01465230|OG000|Outcome|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
11364478|NCT01465230|EG000|Reported Event|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
11364479|NCT01464723|BG000|Baseline|Lucentis|"Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.~Ranibizumab: Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months."
11189081|NCT02117687|FG001|Participant Flow|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
11364480|NCT01464723|FG000|Participant Flow|Lucentis|"Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.~Ranibizumab : Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months."
11364481|NCT01464723|OG000|Outcome|Lucentis|"Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.~Ranibizumab : Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months."
11364482|NCT01464723|EG000|Reported Event|Lucentis|"Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.~Ranibizumab : Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months."
11364483|NCT01446250|BG000|Baseline|All Enrolled Participants|Analysis was performed on all enrolled participants.
11364484|NCT01446250|FG000|Participant Flow|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
11364485|NCT01446250|FG001|Participant Flow|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
11189082|NCT02117687|OG000|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
11364486|NCT01446250|FG002|Participant Flow|PEGinf + RBV|Participants who received ALV in Treatment Period 1 were put on clinical hold but continued receiving PEGinf and RBV for 4 weeks, after which they switched to BOC triple therapy in Treatment Period 2.
11364487|NCT01446250|FG003|Participant Flow|No Intervention|Participants who had an End of Treatment Response (ETR) were followed-up for 24 weeks after the last dose of BOC triple therapy (in Treatment Period 2) and participants who did not respond for any reason or discontinued the treatment early were followed-up for 12 weeks after the last dose of BOC (in Treatment Period 2).
11364488|NCT01446250|OG000|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
11364489|NCT01446250|OG001|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
11364490|NCT01446250|EG000|Reported Event|Alisporivir|Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV.
11364491|NCT01446250|EG001|Reported Event|Boceprevir|AE occurred while taking Boceprevir + PEGinf + RBV.
11364492|NCT01446250|EG002|Reported Event|PEGinf + RBV|AE occurred while taking only PEGinf + RBV.
11364493|NCT01446250|EG003|Reported Event|No Intervention|AE was discovered while taking no intervention.
11364494|NCT01463293|BG000|Baseline|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
11364495|NCT01463293|BG001|Baseline|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
11364496|NCT01463293|BG002|Baseline|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
11364497|NCT01463293|BG003|Baseline|Total|Total of all reporting groups
11364498|NCT01463293|FG000|Participant Flow|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
11364499|NCT01463293|FG001|Participant Flow|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
11364500|NCT01463293|FG002|Participant Flow|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
11364501|NCT01463293|OG000|Outcome|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
11364502|NCT01463293|OG001|Outcome|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
11364503|NCT01463293|OG002|Outcome|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
11364504|NCT01463293|EG000|Reported Event|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
11364505|NCT01463293|EG001|Reported Event|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
11364506|NCT01463293|EG002|Reported Event|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
11364507|NCT01457053|BG000|Baseline|All Study Participants|2 subjects completed the study. 2 subjects did not complete either arm and did not have usable data.
11189083|NCT02117687|OG001|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
11364508|NCT01457053|FG000|Participant Flow|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
11364509|NCT01457053|FG001|Participant Flow|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
11364510|NCT01457053|OG000|Outcome|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
11364511|NCT01457053|OG001|Outcome|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
11364512|NCT01457053|EG000|Reported Event|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
11189084|NCT02117687|EG000|Reported Event|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
11364513|NCT01457053|EG001|Reported Event|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
11364514|NCT01451723|BG000|Baseline|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
11364515|NCT01451723|BG001|Baseline|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
11364516|NCT01451723|BG002|Baseline|Total|Total of all reporting groups
11364517|NCT01451723|FG000|Participant Flow|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
11364518|NCT01451723|FG001|Participant Flow|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
11364519|NCT01451723|OG000|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
11364520|NCT01451723|OG001|Outcome|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
11364521|NCT01451723|EG000|Reported Event|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
11364522|NCT01451723|EG001|Reported Event|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
11364523|NCT01452854|BG000|Baseline|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
11364524|NCT01452854|FG000|Participant Flow|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
11189085|NCT02117687|EG001|Reported Event|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
11364525|NCT01452854|OG000|Outcome|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
11364526|NCT01452854|EG000|Reported Event|Cancer|"The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).~Low recruitment necessitated the closing of the study. No results available."
11364527|NCT01440517|BG000|Baseline|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
11364528|NCT01440517|FG000|Participant Flow|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
11364529|NCT01440517|OG000|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
11189086|NCT02117713|BG000|Baseline|Core Study Period|Participant received LUM001 also known as Maralixibat (MRX) administered orally once per day.
11364530|NCT01440517|EG000|Reported Event|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
11364531|NCT01440595|BG000|Baseline|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
11364532|NCT01440595|BG001|Baseline|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
11364533|NCT01440595|BG002|Baseline|Total|Total of all reporting groups
11364534|NCT01440595|FG000|Participant Flow|Grazoprevir 200 mg + Peg-IFN + RBV|Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
11364535|NCT01440595|FG001|Participant Flow|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
11364536|NCT01440595|FG002|Participant Flow|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
11364537|NCT01440595|OG000|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
11364538|NCT01440595|OG001|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
11364539|NCT01440595|EG000|Reported Event|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
11364540|NCT01440595|EG001|Reported Event|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
11364541|NCT01446796|BG000|Baseline|Continuous RV Pacing|Study terminated early due to recruitment
10962730|NCT00868231|FG000|Participant Flow|Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
11189087|NCT02117713|FG000|Participant Flow|LUM001 (Maralixibat)|Participant received LUM001 also known as Maralixibat (MRX) administered orally once per day for up to 216 weeks.
11189088|NCT02117713|OG000|Outcome|MRX Baseline Value|These are the MRX baseline values for participants
11189089|NCT02117713|OG001|Outcome|Maralixibat Week 48 Values|Week 48 values for participants.
11189090|NCT02117713|OG000|Outcome|Maralixibat Baseline Values|These are the MRX baseline values for participants.
11189091|NCT02117713|OG001|Outcome|Week 216|These are the week 216 values of participants
11189092|NCT02117713|OG001|Outcome|Week 218|These are values from Week 218.
11189093|NCT02117713|OG001|Outcome|Week 216 Values|These are the week 216 values for participants.
11189094|NCT02117713|OG001|Outcome|Week 216 Values|These are the 2616 values for participants.
11189095|NCT02117713|OG001|Outcome|Week 216|These are the week 216 values for participants.
11189096|NCT02117713|OG001|Outcome|Week 216 Values|These are the week 216 values of the participants.
11189097|NCT02117713|EG000|Reported Event|LUM001 (Maralixibat)|Participant received LUM001 (also known as Maralixibat or MRX) as oral solution once daily based on participant's weight. The dose was escalated from 14, 35, 70, 140 and 280 microgram per kilogram per day (mcg/kg/day) for 4-week dose escalation period. During 8-weeks of dose optimization period, drug was adjusted in titrated manner and dosing was continued to complete the stable dosing and safety monitoring periods for up to 96 weeks of cumulative LUM001 exposure in this study. Dosing during long-term optional follow-up treatment periods 1 and 2 was maintained at the same dose levels as at weeks 96 and 144 for participants rolling over into these treatment periods respectively.
11189098|NCT02117934|BG000|Baseline|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
11189099|NCT02117934|BG001|Baseline|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
11189100|NCT02117934|BG002|Baseline|Total|Total of all reporting groups
11189101|NCT02117934|FG000|Participant Flow|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
11189102|NCT02117934|FG001|Participant Flow|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
11189103|NCT02117934|OG000|Outcome|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
11189104|NCT02117934|OG001|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
11189105|NCT02117934|EG000|Reported Event|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
11189106|NCT02117934|EG001|Reported Event|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
11189107|NCT02117999|BG000|Baseline|Standard CL|Participants undergoing standard corneal cross-linking
11189108|NCT02117999|BG001|Baseline|T-ionto CL|Participants undergoing transepithelial corneal cross-linking with iontophoresis
11189109|NCT02117999|BG002|Baseline|Total|Total of all reporting groups
11189110|NCT02117999|FG000|Participant Flow|T-ionto CL|Eyes undergoing transepithelial corneal cross-linking with iontophoresis
11189111|NCT02117999|FG001|Participant Flow|Standard CL|Eyes undergoing standard corneal cross-linking
11189112|NCT02117999|OG000|Outcome|Transepithelial Corneal Cross-linking Using Iontophoresis|"Transepithelial corneal cross-linking using iontophoresis~Transepithelial corneal cross-linking using iontophoresis: The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes."
11189113|NCT02117999|OG001|Outcome|Standard Corneal Cross-linking|"Standard corneal cross-linking~Standard corneal cross-linking: In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes."
11189114|NCT02117999|OG000|Outcome|T-ionto CL|Participants undergoing transepithelial corneal cross-linking with iontophoresis
11364542|NCT01446796|FG000|Participant Flow|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
11189115|NCT02117999|OG001|Outcome|Standard CL|Participants undergoing standard corneal cross-linking
11189116|NCT02117999|EG000|Reported Event|Transepithelial Corneal Cross-linking Using Iontophoresis|Participants undergoing transepithelial corneal cross-linking using iontophoresis
11189117|NCT02117999|EG001|Reported Event|Standard Corneal Cross-linking|Participants undergoing standard corneal cross-linking
11189118|NCT02118012|BG000|Baseline|Chlorcyclizine and RBV|"Chlorcyclizine HCl and Ribavirin~Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)"
11364543|NCT01446796|FG001|Participant Flow|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
11364544|NCT01446796|OG000|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
11240099|NCT02476175|BG000|Baseline|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
11240100|NCT02476175|FG000|Participant Flow|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
11240101|NCT02476175|OG000|Outcome|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
11240102|NCT02476175|EG000|Reported Event|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
11240103|NCT02476357|BG000|Baseline|Harmonic|Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)
11240104|NCT02476357|BG001|Baseline|Control|Monopolar scalpel and ligature
11240105|NCT02476357|BG002|Baseline|Total|Total of all reporting groups
11240106|NCT02476357|FG000|Participant Flow|Harmonic|"Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)~Harmonic scalpel"
11240107|NCT02476357|FG001|Participant Flow|Control|"Monopolar scalpel and ligature~Harmonic scalpel"
11240108|NCT02476357|OG000|Outcome|Harmonic|Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)
11240109|NCT02476357|OG001|Outcome|Control|Monopolar scalpel and ligature
11240110|NCT02476357|OG000|Outcome|Harmonic|"Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)~Harmonic scalpel"
11240111|NCT02476357|OG001|Outcome|Control|"Monopolar scalpel and ligature~Harmonic scalpel"
11240112|NCT02476357|EG000|Reported Event|Harmonic|Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)
11240113|NCT02476357|EG001|Reported Event|Control|Monopolar scalpel and ligature
11240114|NCT02476422|BG000|Baseline|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
11240115|NCT02476422|BG001|Baseline|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
11240116|NCT02476422|BG002|Baseline|Total|Total of all reporting groups
11240117|NCT02476422|FG000|Participant Flow|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
11240118|NCT02476422|FG001|Participant Flow|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
11240119|NCT02476422|OG000|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
11240120|NCT02476422|OG001|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
11240121|NCT02476422|EG000|Reported Event|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
11364545|NCT01446796|OG001|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
11364546|NCT01446796|OG000|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
11364547|NCT01446796|OG001|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
11364548|NCT01446796|EG000|Reported Event|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
11364549|NCT01446796|EG001|Reported Event|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
11364550|NCT01443923|BG000|Baseline|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
11364551|NCT01443923|BG001|Baseline|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
11364552|NCT01443923|BG002|Baseline|Total|Total of all reporting groups
11364553|NCT01443923|FG000|Participant Flow|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
11364554|NCT01443923|FG001|Participant Flow|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
11364555|NCT01443923|OG000|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
11364556|NCT01443923|OG001|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
11364557|NCT01443923|EG000|Reported Event|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
11364558|NCT01443923|EG001|Reported Event|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
11364559|NCT01439347|BG000|Baseline|Vincristine Sulfate Injection (VSI)|VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.
11364560|NCT01439347|BG001|Baseline|Marqibo|Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.
11364561|NCT01439347|BG002|Baseline|Total|Total of all reporting groups
11364562|NCT01439347|FG000|Participant Flow|Vincristine Sulfate Injection (VSI)|VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.
11364563|NCT01439347|FG001|Participant Flow|Marqibo|Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.
11364564|NCT01439347|OG000|Outcome|Vincristine Sulfate Injection (VSI)|VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.
11364565|NCT01439347|OG001|Outcome|Marqibo|Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.
11364566|NCT01439347|EG000|Reported Event|Vincristine Sulfate Injection (VSI)|VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an IV infusion over 10 minutes.
11364567|NCT01439347|EG001|Reported Event|Marqibo|Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.
11364568|NCT01440452|BG000|Baseline|Group A|"For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (ICSCI) one (1) time per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364569|NCT01440452|BG001|Baseline|Group B|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364570|NCT01440452|BG002|Baseline|Group C|"For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364571|NCT01440452|BG003|Baseline|Group D|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.~Cycling without FES: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364572|NCT01440452|BG004|Baseline|Total|Total of all reporting groups
11377071|NCT00346164|EG002|Reported Event|Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
11364573|NCT01440452|FG000|Participant Flow|Group A|"For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (ICSCI) one (1) time per week during which you will perform functional electrical stimulation (FES) cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364574|NCT01440452|FG001|Participant Flow|Group B|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364575|NCT01440452|FG002|Participant Flow|Group C|"For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364576|NCT01440452|FG003|Participant Flow|Group D|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.~Cycling without FES: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364577|NCT01440452|OG000|Outcome|Group A|"For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (ICSCI) one (1) time per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364578|NCT01440452|OG001|Outcome|Group B|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364579|NCT01440452|OG002|Outcome|Group C|"For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364580|NCT01440452|OG003|Outcome|Group D|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.~Cycling without FES: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364581|NCT01440452|EG000|Reported Event|Group A|"For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (ICSCI) one (1) time per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364582|NCT01440452|EG001|Reported Event|Group B|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364583|NCT01440452|EG002|Reported Event|Group C|"For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364584|NCT01440452|EG003|Reported Event|Group D|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.~Cycling without FES: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon)."
11364585|NCT01433471|BG000|Baseline|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
11364586|NCT01433471|BG001|Baseline|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
11364587|NCT01433471|BG002|Baseline|Total|Total of all reporting groups
11364588|NCT01433471|FG000|Participant Flow|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
11364589|NCT01433471|FG001|Participant Flow|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
11364590|NCT01433471|OG000|Outcome|Trichuris Suis Ova|
11364591|NCT01433471|OG001|Outcome|Placebo|
11364592|NCT01433471|OG000|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
11364593|NCT01433471|OG001|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
11364594|NCT01433471|EG000|Reported Event|Trichuris Suis Ova|
11364595|NCT01433471|EG001|Reported Event|Placebo|
11364596|NCT01436084|BG000|Baseline|SB1518|400 mg orally a day for 28 day cycle.
11189119|NCT02118012|BG001|Baseline|Chlorcyclizine HCl Only|"chlorcyclizine HCl (75 mg twice daily)~Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)"
11364597|NCT01436084|FG000|Participant Flow|SB1518|400 mg orally a day for 28 day cycle.
11364598|NCT01436084|OG000|Outcome|SB1518|400 mg orally a day for 28 day cycle.
11364599|NCT01436084|EG000|Reported Event|SB1518|400 mg orally a day for 28 day cycle.
11364600|NCT01434511|BG000|Baseline|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
11364601|NCT01434511|FG000|Participant Flow|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
11364602|NCT01434511|OG000|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
11364603|NCT01434511|EG000|Reported Event|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
11364604|NCT01426555|BG000|Baseline|ZA Infusion Arm|Thirty five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
11189120|NCT02118012|BG002|Baseline|Total|Total of all reporting groups
11189121|NCT02118012|FG000|Participant Flow|Chlorcyclizine and RBV|"Chlorcyclizine HCl and Ribavirin~Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)"
11189122|NCT02118012|FG001|Participant Flow|Chlorcyclizine HCl Only|"chlorcyclizine HCl (75 mg twice daily)~Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)"
11364605|NCT01426555|BG001|Baseline|Rowing Arm|Thirty five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
11364606|NCT01426555|BG002|Baseline|Total|Total of all reporting groups
11364607|NCT01426555|FG000|Participant Flow|Rowing Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.~In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.~All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
11364608|NCT01426555|FG001|Participant Flow|ZA Infusion Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.~In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.~After the observation period, subjects in the FES rowing plus zoledronic acid arm were planned to receive Zoledronic Acid (Reclast ®) administered as a dose of 5mg intravenously.~All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
11364609|NCT01426555|OG000|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.~No Data was analyzed because dataset is not available to VABHS Study team."
11364610|NCT01426555|OG001|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.~No Data was analyzed because dataset is not available to VABHS Study team."
11364611|NCT01426555|OG000|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, were enrolled.~Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
11364612|NCT01426555|OG001|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, enrolled.~Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
11364613|NCT01426555|EG000|Reported Event|ZA Infusion Arm|No adverse event data were available for the remaining 9 participants.
11364614|NCT01426555|EG001|Reported Event|Rowing Arm|No adverse event data were available for the remaining 16 participants.
11189123|NCT02118012|OG000|Outcome|Chlorcyclizine and RBV|"Chlorcyclizine HCl and Ribavirin~Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)"
11189124|NCT02118012|OG001|Outcome|Chlorcyclizine HCl Only|"chlorcyclizine HCl (75 mg twice daily)~Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)"
11189125|NCT02118012|EG000|Reported Event|Chlorcyclizine and RBV|"Chlorcyclizine HCl and Ribavirin~Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)"
11189126|NCT02118012|EG001|Reported Event|Chlorcyclizine HCl Only|"chlorcyclizine HCl (75 mg twice daily)~Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)"
11189127|NCT02118337|BG000|Baseline|MEDI0680 0.1 mg/kg + Durvalumab 3 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg Q2W for up to 12 months.
11364615|NCT01434745|BG000|Baseline|Placebo - Lactose|"Placebo-Lactose~Lactose: Lactose will be administered in a capsule formula."
11364616|NCT01434745|BG001|Baseline|Simvastatin|"0.5 mg/kg body weight/day~Simvastatin: Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day"
11364617|NCT01434745|BG002|Baseline|Total|Total of all reporting groups
11364618|NCT01434745|FG000|Participant Flow|Placebo - Lactose|"Placebo-Lactose~Lactose: Lactose will be administered in a capsule formula."
11364619|NCT01434745|FG001|Participant Flow|Simvastatin|"0.5 mg/kg body weight/day~Simvastatin: Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day"
11189128|NCT02118337|BG001|Baseline|MEDI0680 0.1 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189129|NCT02118337|BG002|Baseline|MEDI0680 0.5 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189130|NCT02118337|BG003|Baseline|MEDI0680 2.5 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189131|NCT02118337|BG004|Baseline|MEDI0680 10 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189132|NCT02118337|BG005|Baseline|MEDI0680 20 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189133|NCT02118337|BG006|Baseline|MEDI0680 20 mg/kg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189134|NCT02118337|BG007|Baseline|MEDI0680 20 mg/kg + Durvalumab 750 mg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189135|NCT02118337|BG008|Baseline|Nivolumab 240 mg|Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189136|NCT02118337|BG009|Baseline|Total|Total of all reporting groups
11364620|NCT01434745|OG000|Outcome|Placebo - Lactose|"Placebo-Lactose~Lactose: Lactose will be administered in a capsule formula."
11364621|NCT01434745|OG001|Outcome|Simvastatin|"0.5 mg/kg body weight/day~Simvastatin: Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day"
11364622|NCT01434745|EG000|Reported Event|Placebo - Lactose|"Placebo-Lactose~Lactose: Lactose will be administered in a capsule formula."
11364623|NCT01434745|EG001|Reported Event|Simvastatin|"0.5 mg/kg body weight/day~Simvastatin: Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day"
11364624|NCT01415986|BG000|Baseline|Group 1|Interstitial Photodynamic Therapy (I-PDT)
11364625|NCT01415986|FG000|Participant Flow|Group 1|Interstitial Photodynamic Therapy (I-PDT). This subject was adminatred with 0.15 mg/kg Foscan on day 1. He was trtaed with I-PDT using 652-nm light at 20 J/cm, 4 days after the drug adminstration. He stayed in a outpatient facility for 3 more days and discharged home.
11364626|NCT01415986|OG000|Outcome|Group 1|Interstitial Photodynamic Therapy (PDT)
11364627|NCT01415986|OG000|Outcome|Group 1|Interstitial Photodynamic Therapy (I-PDT)
11364628|NCT01415986|EG000|Reported Event|Group 1|Interstitial Photodynamic Therapy (I-PDT)
11364629|NCT01410799|BG000|Baseline|Growth Hormone Releasing Hormone (GHRH)|"Drug: GHRH~Growth Hormone Releasing Hormone (GHRH ): GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks"
11364630|NCT01410799|FG000|Participant Flow|Growth Hormone Releasing Hormone (GHRH)|"Drug: GHRH~Growth Hormone Releasing Hormone (GHRH ): GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks"
11364631|NCT01410799|OG000|Outcome|Growth Hormone Releasing Hormone (GHRH)|"Drug: GHRH~Growth Hormone Releasing Hormone (GHRH ): GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks"
11364632|NCT01410799|EG000|Reported Event|Growth Hormone Releasing Hormone (GHRH)|"Drug: GHRH~Growth Hormone Releasing Hormone (GHRH ): GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks"
11364633|NCT01426113|BG000|Baseline|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
11364634|NCT01426113|BG001|Baseline|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
11364635|NCT01426113|BG002|Baseline|Total|Total of all reporting groups
11364636|NCT01426113|FG000|Participant Flow|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
11364637|NCT01426113|FG001|Participant Flow|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
11364638|NCT01426113|OG000|Outcome|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
11189137|NCT02118337|FG000|Participant Flow|MEDI0680 0.1 mg/kg + Durvalumab 3 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
11364639|NCT01426113|OG001|Outcome|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
11364640|NCT01426113|EG000|Reported Event|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
11364641|NCT01426113|EG001|Reported Event|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
11364642|NCT01426516|BG000|Baseline|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
11364643|NCT01426516|BG001|Baseline|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
11364644|NCT01426516|BG002|Baseline|Total|Total of all reporting groups
11364645|NCT01426516|FG000|Participant Flow|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
11364646|NCT01426516|FG001|Participant Flow|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
11364647|NCT01426516|OG000|Outcome|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
11364648|NCT01426516|OG001|Outcome|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
11364649|NCT01426516|EG000|Reported Event|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
11364650|NCT01426516|EG001|Reported Event|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
11364651|NCT01420965|BG000|Baseline|Arm A|"Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)~Sipuleucel-T (Provenge): Vaccine"
11364652|NCT01420965|BG001|Baseline|Arm B|"Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion~CT-011 (Anti-PD1 Antibody): Immune Enhancer~Sipuleucel-T (Provenge): Vaccine"
11364653|NCT01420965|BG002|Baseline|Arm C|"Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV [first cycle only] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion~CT-011 (Anti-PD1 Antibody): Immune Enhancer~Sipuleucel-T (Provenge): Vaccine~Cyclophosphamide: Low dose- Immune Enhancer"
11364654|NCT01420965|BG003|Baseline|Total|Total of all reporting groups
11364655|NCT01420965|FG000|Participant Flow|Arm A|"Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)~Sipuleucel-T (Provenge): Vaccine"
11364656|NCT01420965|FG001|Participant Flow|Arm B|"Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion~CT-011 (Anti-PD1 Antibody): Immune Enhancer~Sipuleucel-T (Provenge): Vaccine"
11364657|NCT01420965|FG002|Participant Flow|Arm C|"Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV [first cycle only] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion~CT-011 (Anti-PD1 Antibody): Immune Enhancer~Sipuleucel-T (Provenge): Vaccine~Cyclophosphamide: Low dose- Immune Enhancer"
11364658|NCT01420965|OG000|Outcome|Arm A|"Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)~Sipuleucel-T (Provenge): Vaccine"
11364659|NCT01420965|OG001|Outcome|Arm B|"Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion~CT-011 (Anti-PD1 Antibody): Immune Enhancer~Sipuleucel-T (Provenge): Vaccine"
11364660|NCT01420965|OG002|Outcome|Arm C|"Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV [first cycle only] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion~CT-011 (Anti-PD1 Antibody): Immune Enhancer~Sipuleucel-T (Provenge): Vaccine~Cyclophosphamide: Low dose- Immune Enhancer"
11364661|NCT01420965|EG000|Reported Event|Arm A|"Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)~Sipuleucel-T (Provenge): Vaccine"
11364662|NCT01420965|EG001|Reported Event|Arm B|"Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion~CT-011 (Anti-PD1 Antibody): Immune Enhancer~Sipuleucel-T (Provenge): Vaccine"
11364663|NCT01420965|EG002|Reported Event|Arm C|"Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV [first cycle only] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion~CT-011 (Anti-PD1 Antibody): Immune Enhancer~Sipuleucel-T (Provenge): Vaccine~Cyclophosphamide: Low dose- Immune Enhancer"
11364664|NCT01417377|BG000|Baseline|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
11364665|NCT01417377|FG000|Participant Flow|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
11189138|NCT02118337|FG001|Participant Flow|MEDI0680 0.1 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11364666|NCT01417377|OG000|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
11364667|NCT01417377|EG000|Reported Event|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
11364668|NCT01416272|BG000|Baseline|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
11364669|NCT01416272|FG000|Participant Flow|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
11364670|NCT01416272|OG000|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
11364671|NCT01416272|EG000|Reported Event|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
11364672|NCT01414166|BG000|Baseline|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
11364673|NCT01414166|BG001|Baseline|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
11364674|NCT01414166|BG002|Baseline|Total|Total of all reporting groups
11364675|NCT01414166|FG000|Participant Flow|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
11364676|NCT01414166|FG001|Participant Flow|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
11364677|NCT01414166|OG000|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
11364678|NCT01414166|OG001|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
11364679|NCT01414166|EG000|Reported Event|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
11364680|NCT01414166|EG001|Reported Event|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
11364681|NCT01406860|BG000|Baseline|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
11364682|NCT01406860|BG001|Baseline|Metoclopramide + Diphenhydramine|"Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.~Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion."
11364683|NCT01406860|BG002|Baseline|Total|Total of all reporting groups
11364684|NCT01406860|FG000|Participant Flow|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
11364685|NCT01406860|FG001|Participant Flow|Metoclopramide + Diphenhydramine|Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.
11364686|NCT01406860|OG000|Outcome|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
11364687|NCT01406860|OG001|Outcome|Metoclopramide + Diphenhydramine|"Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.~Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion."
11364688|NCT01406860|OG001|Outcome|Metoclopramide|Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.
11364689|NCT01406860|EG000|Reported Event|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
11364690|NCT01406860|EG001|Reported Event|Metoclopramide|"Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.~Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion."
11364691|NCT01401049|BG000|Baseline|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
11364692|NCT01401049|BG001|Baseline|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
11364693|NCT01401049|BG002|Baseline|Total|Total of all reporting groups
11364694|NCT01401049|FG000|Participant Flow|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
11364695|NCT01401049|FG001|Participant Flow|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
11364696|NCT01401049|OG000|Outcome|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
11364697|NCT01401049|OG001|Outcome|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
11364698|NCT01401049|EG000|Reported Event|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
11364699|NCT01401049|EG001|Reported Event|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
11364700|NCT01409031|BG000|Baseline|Intravenous Sildenafil|Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
11364701|NCT01409031|BG001|Baseline|Placebo|"0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.~Placebo: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days."
11364702|NCT01409031|BG002|Baseline|Total|Total of all reporting groups
11364703|NCT01409031|FG000|Participant Flow|Intravenous Sildenafil|Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
11364704|NCT01409031|FG001|Participant Flow|Placebo|"0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.~Placebo: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days."
11364705|NCT01409031|OG000|Outcome|Intravenous Sildenafil|Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
11364706|NCT01409031|OG001|Outcome|Placebo|"0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.~Placebo: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days."
11364707|NCT01409031|EG000|Reported Event|Intravenous Sildenafil|Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
11364708|NCT01409031|EG001|Reported Event|Placebo|"0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.~Placebo: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days."
11364709|NCT01402531|BG000|Baseline|No Participants|The Investigator of this study passed away and we do not have the study data to upload the results.
11364710|NCT01402531|FG000|Participant Flow|Submucosal Bevacizumab|"200mg Bevacizumab, submucosal injection~Submucosal Bevacizumab: 200 mg Bevacizumab, injected submucosally- 100 mg per nostril"
11364711|NCT01402531|OG000|Outcome|No Participants|The Investigator of this study passed away and we do not have the study data to upload the results.
11364712|NCT01402531|EG000|Reported Event|No Participants|The Investigator of this study passed away and we do not have the study data to upload the results.
11364713|NCT01394926|BG000|Baseline|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
11364714|NCT01394926|FG000|Participant Flow|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
11364715|NCT01394926|OG000|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1 given as an Injection of 0.15mL of Optison at time 0.
11364716|NCT01394926|OG001|Outcome|Dose Level 2: 0.5mL of Optsion at Time 6.5 Minutes|Dose Level 2: Inj. of 0.5mL Optsion at time 6.5 minutes post dose level 1.
11364717|NCT01394926|OG002|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post level 2.
11364718|NCT01394926|OG000|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1: Injection of 0.15mL Optison at time 0.
11364719|NCT01394926|OG001|Outcome|Dose Level 2: 0.5mL Optison at Time 6.5 Minutes|Dose Level 2: Injection given of 0.5mL of Optison at 6.5 minutes post dose level 1.
11364720|NCT01394926|OG002|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post dose level 2.
11364721|NCT01394926|EG000|Reported Event|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
11364722|NCT01383681|BG000|Baseline|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
11364723|NCT01383681|FG000|Participant Flow|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
11364724|NCT01383681|OG000|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
11364725|NCT01383681|EG000|Reported Event|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
11364726|NCT01403194|BG000|Baseline|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
11364727|NCT01403194|FG000|Participant Flow|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
11364728|NCT01403194|OG000|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
11364729|NCT01403194|EG000|Reported Event|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
11364730|NCT01397552|BG000|Baseline|Dexamethasone|"Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded~Dexamethasone: 10 mg/mL injected into lumbar spine, one level, one injection"
11364731|NCT01397552|BG001|Baseline|Methylprednisolone Acetate|"Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded~methylprednisolone acetate: 80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time"
11364732|NCT01397552|BG002|Baseline|Total|Total of all reporting groups
11364733|NCT01397552|FG000|Participant Flow|Dexamethasone|"Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded~Dexamethasone: 10 mg/mL injected into lumbar spine, one level, one injection"
11364734|NCT01397552|FG001|Participant Flow|Methylprednisolone Acetate|"Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded~methylprednisolone acetate: 80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time"
11364735|NCT01397552|OG000|Outcome|Dexamethasone|"Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded~Dexamethasone: 10 mg/mL injected into lumbar spine, one level, one injection"
11364736|NCT01397552|OG001|Outcome|Methylprednisolone Acetate|"Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded~methylprednisolone acetate: 80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time"
11364737|NCT01397552|EG000|Reported Event|Dexamethasone|"Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded~Dexamethasone: 10 mg/mL injected into lumbar spine, one level, one injection"
11364738|NCT01397552|EG001|Reported Event|Methylprednisolone Acetate|"Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded~methylprednisolone acetate: 80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time"
11364739|NCT01392170|BG000|Baseline|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
11364740|NCT01392170|FG000|Participant Flow|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
11364741|NCT01392170|OG000|Outcome|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
11364742|NCT01392170|EG000|Reported Event|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
11364743|NCT01389817|BG000|Baseline|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
11364744|NCT01389817|BG001|Baseline|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
11364745|NCT01389817|BG002|Baseline|Total|Total of all reporting groups
11364746|NCT01389817|FG000|Participant Flow|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
11364747|NCT01389817|FG001|Participant Flow|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
11364748|NCT01389817|OG000|Outcome|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
11364749|NCT01389817|OG001|Outcome|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
11364750|NCT01389817|EG000|Reported Event|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
11364751|NCT01389817|EG001|Reported Event|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
11364752|NCT01397695|BG000|Baseline|Bevacizumab|Bevacizumab: The bevacizumab will then be sprayed by the treating physician in the clinic, under direct observation. Spray will be achieved by administering the bevacizumab through a mucosal atomization device. 0.1cc will be sprayed into both nares. Patients will then sit for 5 minutes, the application will be repeated for a total of 40 applications, thereby administering 50mgs into each nostril, a total of 100mgs into each patient. The 5 minute spacing has been arbitrarily chosen as sufficient time for 0.1cc of solution to be absorbed by the nasal mucosa. That will complete the treatment.
11364753|NCT01397695|FG000|Participant Flow|Bevacizumab|Bevacizumab: The bevacizumab will then be sprayed by the treating physician in the clinic, under direct observation. Spray will be achieved by administering the bevacizumab through a mucosal atomization device. 0.1cc will be sprayed into both nares. Patients will then sit for 5 minutes, the application will be repeated for a total of 40 applications, thereby administering 50mgs into each nostril, a total of 100mgs into each patient. The 5 minute spacing has been arbitrarily chosen as sufficient time for 0.1cc of solution to be absorbed by the nasal mucosa. That will complete the treatment.
11364754|NCT01397695|OG000|Outcome|Bevacizumab|Bevacizumab: The bevacizumab will then be sprayed by the treating physician in the clinic, under direct observation. Spray will be achieved by administering the bevacizumab through a mucosal atomization device. 0.1cc will be sprayed into both nares. Patients will then sit for 5 minutes, the application will be repeated for a total of 40 applications, thereby administering 50mgs into each nostril, a total of 100mgs into each patient. The 5 minute spacing has been arbitrarily chosen as sufficient time for 0.1cc of solution to be absorbed by the nasal mucosa. That will complete the treatment.
11364755|NCT01397695|EG000|Reported Event|Bevacizumab|Bevacizumab: The bevacizumab will then be sprayed by the treating physician in the clinic, under direct observation. Spray will be achieved by administering the bevacizumab through a mucosal atomization device. 0.1cc will be sprayed into both nares. Patients will then sit for 5 minutes, the application will be repeated for a total of 40 applications, thereby administering 50mgs into each nostril, a total of 100mgs into each patient. The 5 minute spacing has been arbitrarily chosen as sufficient time for 0.1cc of solution to be absorbed by the nasal mucosa. That will complete the treatment.
11364756|NCT01390181|BG000|Baseline|Losartan|Cozaar: Angiotensin II Receptor Blocker
11364757|NCT01390181|FG000|Participant Flow|Losartan|Cozaar: Angiotensin II Receptor Blocker
11364758|NCT01390181|OG000|Outcome|Losartan|Cozaar: Angiotensin II Receptor Blocker
11364759|NCT01390181|EG000|Reported Event|Losartan|Cozaar: Angiotensin II Receptor Blocker
11364760|NCT01385033|BG000|Baseline|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
11364761|NCT01385033|BG001|Baseline|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
11364762|NCT01385033|BG002|Baseline|Total|Total of all reporting groups
11364763|NCT01385033|FG000|Participant Flow|Alzheimer's Disease (AD) Participants (Part I)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by positron emission tomography (PET) imaging of the brain (Part I)
11364764|NCT01385033|FG001|Participant Flow|Healthy Elderly (HE) Participants (Part I)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part I)
11364765|NCT01385033|FG002|Participant Flow|AD Participants (Part II)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by PET imaging of the brain (Part II)
11364766|NCT01385033|FG003|Participant Flow|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
11364767|NCT01385033|FG004|Participant Flow|Healthy Young (HY) Participants (Part II)|HY participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
11364768|NCT01385033|FG005|Participant Flow|Amnestic Mild Cognitive Impairment Participants (Part III)|Participants with amnestic Mild Cognitive Impairment received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part III)
11364769|NCT01385033|OG000|Outcome|AD and HE Participants|AD and HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
11364770|NCT01385033|OG000|Outcome|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
11364771|NCT01385033|OG001|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
11364772|NCT01385033|OG000|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
11364773|NCT01385033|EG000|Reported Event|All Study Participants|Participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
11364774|NCT01394211|BG000|Baseline|Neoadjuvant Enzyme Inhibitor Therapy|"Patients receive pazopanib hydrochloride* PO QD and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo therapeutic conventional surgery.~NOTE: *Pazopanib hydrochloride is stopped 7-14 days before definitive surgery.~anastrozole: Given PO~pazopanib hydrochloride: Given PO~therapeutic conventional surgery: Undergo definitive surgery"
11364775|NCT01394211|FG000|Participant Flow|Neoadjuvant Enzyme Inhibitor Therapy|"Patients receive pazopanib hydrochloride* PO QD and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo therapeutic conventional surgery.~NOTE: *Pazopanib hydrochloride is stopped 7-14 days before definitive surgery.~anastrozole: Given PO~pazopanib hydrochloride: Given PO~therapeutic conventional surgery: Undergo definitive surgery"
11364776|NCT01394211|OG000|Outcome|Neoadjuvant Enzyme Inhibitor Therapy|"Patients receive pazopanib hydrochloride* PO QD and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo therapeutic conventional surgery.~NOTE: *Pazopanib hydrochloride is stopped 7-14 days before definitive surgery.~anastrozole: Given PO~pazopanib hydrochloride: Given PO~therapeutic conventional surgery: Undergo definitive surgery"
11364777|NCT01394211|EG000|Reported Event|Neoadjuvant Enzyme Inhibitor Therapy|"Patients receive pazopanib hydrochloride* PO QD and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo therapeutic conventional surgery.~NOTE: *Pazopanib hydrochloride is stopped 7-14 days before definitive surgery.~anastrozole: Given PO~pazopanib hydrochloride: Given PO~therapeutic conventional surgery: Undergo definitive surgery"
11364778|NCT01377441|BG000|Baseline|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
11364779|NCT01377441|BG001|Baseline|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
11364780|NCT01377441|BG002|Baseline|Total|Total of all reporting groups
11364781|NCT01377441|FG000|Participant Flow|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
11364782|NCT01377441|FG001|Participant Flow|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
11364783|NCT01377441|OG000|Outcome|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
11364784|NCT01377441|OG001|Outcome|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
11364785|NCT01377441|EG000|Reported Event|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
11364786|NCT01377441|EG001|Reported Event|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
11364787|NCT01383447|BG000|Baseline|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
11364788|NCT01383447|FG000|Participant Flow|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
11364789|NCT01383447|OG000|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
11364790|NCT01383447|EG000|Reported Event|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
11364791|NCT01372618|BG000|Baseline|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
11364792|NCT01372618|FG000|Participant Flow|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
11364793|NCT01372618|OG000|Outcome|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
11364794|NCT01372618|EG000|Reported Event|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
11364795|NCT01385280|BG000|Baseline|Arm I|"Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.~therapeutic estradiol: Given orally (PO)~exemestane: Given PO~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies"
11364796|NCT01385280|FG000|Participant Flow|Arm I|"Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.~therapeutic estradiol: Given orally (PO)~exemestane: Given PO~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies"
11364797|NCT01385280|OG000|Outcome|Arm I|"Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.~therapeutic estradiol: Given orally (PO)~exemestane: Given PO~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies"
11364798|NCT01385280|EG000|Reported Event|Arm I|"Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.~therapeutic estradiol: Given orally (PO)~exemestane: Given PO~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies"
11364799|NCT01379274|BG000|Baseline|Lenalidomide and Azacitidine Combination|"Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.~Lenalidomide and azacitidine combination: lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.~Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy."
11364800|NCT01379274|FG000|Participant Flow|Lenalidomide and Azacitidine Combination|"Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.~Lenalidomide and azacitidine combination: lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.~Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy."
11364801|NCT01379274|OG000|Outcome|Lenalidomide and Azacitidine Combination|"Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.~Lenalidomide and azacitidine combination: lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.~Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy."
11364802|NCT01379274|EG000|Reported Event|Lenalidomide and Azacitidine Combination|"Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.~Lenalidomide and azacitidine combination: lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.~Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy."
11364803|NCT01379469|BG000|Baseline|Drug-Carbamazepine (Tegretol XR)|"One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Drug-Carbamazepine (Tegretol XR): To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated, and the placebo group will receive encapsulated tablets without CBZ."
11364804|NCT01379469|BG001|Baseline|Drug-Carbamazepine (Tegretol XR) Placebo|"One arm receives Carbamazepine (Tegretol-XR) placebo.All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Carbamazepine (Tegretol XR) Placebo: Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine."
11364805|NCT01379469|BG002|Baseline|Total|Total of all reporting groups
11364806|NCT01379469|FG000|Participant Flow|Drug-Carbamazepine (Tegretol XR)|"One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Drug-Carbamazepine (Tegretol XR): To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated."
11364807|NCT01379469|FG001|Participant Flow|Drug-Carbamazepine (Tegretol XR) Placebo|"One arm receives Carbamazepine (Tegretol-XR) placebo.All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Carbamazepine (Tegretol XR) Placebo: Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine."
11364808|NCT01379469|OG000|Outcome|Drug-Carbamazepine (Tegretol XR)|"One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Drug-Carbamazepine (Tegretol XR): To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated, and the placebo group will receive encapsulated tablets without CBZ."
11364809|NCT01379469|OG001|Outcome|Drug-Carbamazepine (Tegretol XR) Placebo|"One arm receives Carbamazepine (Tegretol-XR) placebo.All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Carbamazepine (Tegretol XR) Placebo: Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine."
11364810|NCT01379469|EG000|Reported Event|Drug-Carbamazepine (Tegretol XR)|"One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Drug-Carbamazepine (Tegretol XR): To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated, and the placebo group will receive encapsulated tablets without CBZ."
11364811|NCT01379469|EG001|Reported Event|Drug-Carbamazepine (Tegretol XR) Placebo|"One arm receives Carbamazepine (Tegretol-XR) placebo.All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Carbamazepine (Tegretol XR) Placebo: Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine."
11364812|NCT01369641|BG000|Baseline|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
11364813|NCT01369641|FG000|Participant Flow|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
11364814|NCT01369641|OG000|Outcome|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
11364815|NCT01369641|EG000|Reported Event|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
11364816|NCT01365156|BG000|Baseline|Surgery Group|Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation
11364817|NCT01365156|BG001|Baseline|Chemoradiation Group|Standard of care whole pelvic chemoradiation therapy
11364818|NCT01365156|BG002|Baseline|Total|Total of all reporting groups
11364819|NCT01365156|FG000|Participant Flow|Surgery Group|Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation
11364820|NCT01365156|FG001|Participant Flow|Chemoradiation Group|Standard of care whole pelvic chemoradiation therapy
11364821|NCT01365156|OG000|Outcome|Surgery Group|Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation
11364822|NCT01365156|OG001|Outcome|Chemoradiation Group|Standard of care whole pelvic chemoradiation therapy
11364823|NCT01365156|EG000|Reported Event|Surgery Group|Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation
11364824|NCT01365156|EG001|Reported Event|Chemoradiation Group|Standard of care whole pelvic chemoradiation therapy
11364825|NCT01359254|BG000|Baseline|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
11364826|NCT01359254|BG001|Baseline|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
11364827|NCT01359254|BG002|Baseline|Total|Total of all reporting groups
11364828|NCT01359254|FG000|Participant Flow|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
11364829|NCT01359254|FG001|Participant Flow|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
11364830|NCT01359254|OG000|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
11364831|NCT01359254|OG001|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
11364832|NCT01359254|EG000|Reported Event|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
11364833|NCT01359254|EG001|Reported Event|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
11364834|NCT01347632|BG000|Baseline|Metronidazole|Open Label Study
11364835|NCT01347632|FG000|Participant Flow|Metronidazole|Open Label Study
11364836|NCT01347632|OG000|Outcome|Metronidazole|Open Label Study
11364837|NCT01347632|EG000|Reported Event|Metronidazole|Open Label Study
11364838|NCT01356667|BG000|Baseline|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
11364839|NCT01356667|BG001|Baseline|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
11364840|NCT01356667|BG002|Baseline|Total|Total of all reporting groups
11364841|NCT01356667|FG000|Participant Flow|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
11364842|NCT01356667|FG001|Participant Flow|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
11364843|NCT01356667|OG000|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
11364844|NCT01356667|OG001|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
11364845|NCT01356667|OG000|Outcome|Treatment-As-Usual|"Substance Abuse treatment typically received~Treatment-As-Usual: Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions."
11364846|NCT01356667|OG001|Outcome|DARTNA|"12-week DARTNA program~DARTNA: 3-hour protocol provided 2x/week over 12 weeks"
11364847|NCT01356667|EG000|Reported Event|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
11364848|NCT01356667|EG001|Reported Event|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
11364849|NCT01354951|BG000|Baseline|Prostate Biopsy, Focal Brachytherapy , Assessment of QOL|This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
11364850|NCT01354951|FG000|Participant Flow|Prostate Biopsy, Focal Brachytherapy , Assessment of QOL|This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
11364851|NCT01354951|OG000|Outcome|Prostate Biopsy, Focal Brachytherapy , Assessment of QOL|This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
11364852|NCT01354951|EG000|Reported Event|Prostate Biopsy, Focal Brachytherapy , Assessment of QOL|This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
11364853|NCT01350232|BG000|Baseline|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
11364854|NCT01350232|FG000|Participant Flow|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
11364855|NCT01350232|OG000|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
11364856|NCT01350232|EG000|Reported Event|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
11364857|NCT01350583|BG000|Baseline|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
11364858|NCT01350583|FG000|Participant Flow|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
11364859|NCT01350583|OG000|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
11364860|NCT01350583|EG000|Reported Event|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
11364861|NCT01352416|BG000|Baseline|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364862|NCT01352416|BG001|Baseline|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364863|NCT01352416|BG002|Baseline|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364864|NCT01352416|BG003|Baseline|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364865|NCT01352416|BG004|Baseline|Total|Total of all reporting groups
11364866|NCT01352416|FG000|Participant Flow|Ranolazine and Patients Having CABG Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364867|NCT01352416|FG001|Participant Flow|Sugar Pill and Patients Having CABG Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.~Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
11364868|NCT01352416|FG002|Participant Flow|Ranolazine With Patients Having Non CABG Heart Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364869|NCT01352416|FG003|Participant Flow|Sugar Pills and Patients Having Non CABG Heart Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.~Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
11364870|NCT01352416|OG000|Outcome|Ranolazine With Coronary Artery Bypass Graft (CABG)|Ranolazine 500 mg 2 pills twice a day with Coronary Artery Bypass Graft (CABG)
11364871|NCT01352416|OG001|Outcome|Placebo With CABG|Placebo 2 pills twice daily with CABG
11364872|NCT01352416|OG002|Outcome|Ranolazine Without CABG|Ranolazine 500 mg 2 pills twice daily without CABG
11364873|NCT01352416|OG003|Outcome|Placebo Without CABG|Placebo 2 pills twice daily without CABG
11364874|NCT01352416|EG000|Reported Event|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364875|NCT01352416|EG001|Reported Event|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11189139|NCT02118337|FG002|Participant Flow|MEDI0680 0.5 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11364876|NCT01352416|EG002|Reported Event|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364877|NCT01352416|EG003|Reported Event|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
11364878|NCT01350258|BG000|Baseline|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
11364879|NCT01350258|FG000|Participant Flow|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
11364880|NCT01350258|OG000|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
11189140|NCT02118337|FG003|Participant Flow|MEDI0680 2.5 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189141|NCT02118337|FG004|Participant Flow|MEDI0680 10 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11364881|NCT01350258|EG000|Reported Event|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
11364882|NCT01349595|BG000|Baseline|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
11364883|NCT01349595|BG001|Baseline|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
11364884|NCT01349595|BG002|Baseline|Total|Total of all reporting groups
11364885|NCT01349595|FG000|Participant Flow|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
11364886|NCT01349595|FG001|Participant Flow|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
11364887|NCT01349595|OG000|Outcome|Bortezomib|Bortezomib is a type of targeted chemotherapy
11364888|NCT01349595|OG001|Outcome|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
11364889|NCT01349595|EG000|Reported Event|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
11364890|NCT01349595|EG001|Reported Event|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
11364891|NCT01337609|BG000|Baseline|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
11364892|NCT01337609|BG001|Baseline|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
11364893|NCT01337609|BG002|Baseline|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
11364894|NCT01337609|BG003|Baseline|Total|Total of all reporting groups
11364895|NCT01337609|FG000|Participant Flow|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
11364896|NCT01337609|FG001|Participant Flow|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
11364897|NCT01337609|FG002|Participant Flow|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
11364898|NCT01337609|OG000|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
11364899|NCT01337609|OG001|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
11364900|NCT01337609|OG002|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
11364901|NCT01337609|EG000|Reported Event|Placebo for 60 Days|
11364902|NCT01337609|EG001|Reported Event|GanedenBC30 for 60 Days|
11364903|NCT01337609|EG002|Reported Event|Placebo for 30 Days, Followed by GanedenBC30 for 30 Days|
11364904|NCT01347840|BG000|Baseline|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
11364905|NCT01347840|FG000|Participant Flow|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
11364906|NCT01347840|OG000|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
11364907|NCT01347840|EG000|Reported Event|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
11364908|NCT01340573|BG000|Baseline|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
11364909|NCT01340573|FG000|Participant Flow|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
11364910|NCT01340573|OG000|Outcome|Genotype 1 CHC Participants|
11364911|NCT01340573|OG001|Outcome|Non-genotype 1 CHC Partipants|
11364912|NCT01340573|EG000|Reported Event|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
11364913|NCT01335997|BG000|Baseline|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
11364914|NCT01335997|BG001|Baseline|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
11364915|NCT01335997|BG002|Baseline|Total|Total of all reporting groups
11364916|NCT01335997|FG000|Participant Flow|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
11364917|NCT01335997|FG001|Participant Flow|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
11364918|NCT01335997|OG000|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
11364919|NCT01335997|OG001|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
11364920|NCT01335997|EG000|Reported Event|Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT/SIMVA 1 g/10 mg for 4 weeks (Period I) followed by ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period II)
11364921|NCT01335997|EG001|Reported Event|Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT 1 g + SIMVA 10 mg for 4 weeks (Period I) followed by ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period II)
11364922|NCT01335997|EG002|Reported Event|Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period III)
11364923|NCT01335997|EG003|Reported Event|Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period III)
11364924|NCT01340885|BG000|Baseline|Atomoxetine|"Strattera 10-30 mg b.i.d.~Strattera: 10-30 mg b.i.d. for 6 weeks"
11364925|NCT01340885|BG001|Baseline|Rivastigimine|"Exelon 1.5-4.5 mg b.i.d.~Exelon: 1.5-4.5 mg b.i.d. for 6 weeks"
11364926|NCT01340885|BG002|Baseline|Placebo|"sugar pill~Placebo: 2-6 pills for 6 weeks"
11364927|NCT01340885|BG003|Baseline|Total|Total of all reporting groups
11364928|NCT01340885|FG000|Participant Flow|Atomoxetine|"Strattera 10-30 mg b.i.d.~Strattera: 10-30 mg b.i.d. for 6 weeks"
11364929|NCT01340885|FG001|Participant Flow|Rivastigimine|"Exelon 1.5-4.5 mg b.i.d.~Exelon: 1.5-4.5 mg b.i.d. for 6 weeks"
11364930|NCT01340885|FG002|Participant Flow|Placebo|"sugar pill~Placebo: 2-6 pills for 6 weeks"
11364931|NCT01340885|OG000|Outcome|Atomoxetine|"Strattera 10-30 mg b.i.d.~Strattera: 10-30 mg b.i.d. for 6 weeks"
11364932|NCT01340885|OG001|Outcome|Rivastigimine|"Exelon 1.5-4.5 mg b.i.d.~Exelon: 1.5-4.5 mg b.i.d. for 6 weeks"
11364933|NCT01340885|OG002|Outcome|Placebo|"sugar pill~Placebo: 2-6 pills for 6 weeks"
11364934|NCT01340885|EG000|Reported Event|Atomoxetine|"Strattera 10-30 mg b.i.d.~Strattera: 10-30 mg b.i.d. for 6 weeks"
11364935|NCT01340885|EG001|Reported Event|Rivastigimine|"Exelon 1.5-4.5 mg b.i.d.~Exelon: 1.5-4.5 mg b.i.d. for 6 weeks"
11364936|NCT01340885|EG002|Reported Event|Placebo|"sugar pill~Placebo: 2-6 pills for 6 weeks"
11364937|NCT01341587|BG000|Baseline|Control|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
11240122|NCT02476422|EG001|Reported Event|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
11364938|NCT01341587|BG001|Baseline|Intervention|"Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.~Care provider can access raw and analyzed patient data; Physician receives report summary.~Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer"
11364939|NCT01341587|BG002|Baseline|Total|Total of all reporting groups
11364940|NCT01341587|FG000|Participant Flow|Control|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
11364941|NCT01341587|FG001|Participant Flow|Intervention|"Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.~Care provider can access raw and analyzed patient data; Physician receives report summary.~Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer"
11364942|NCT01341587|OG000|Outcome|Control|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
11364943|NCT01341587|OG001|Outcome|Intervention|"Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.~Care provider can access raw and analyzed patient data; Physician receives report summary.~Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer"
11364944|NCT01341587|EG000|Reported Event|Control|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
11364945|NCT01341587|EG001|Reported Event|Intervention|"Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.~Care provider can access raw and analyzed patient data; Physician receives report summary.~Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer"
11364946|NCT01326923|BG000|Baseline|Single Arm|"Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer~Cetuximab: Single arm phase II study of chemotherapy"
11364947|NCT01326923|FG000|Participant Flow|Single Arm|"Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer~Cetuximab: Single arm phase II study of chemotherapy"
11364948|NCT01326923|OG000|Outcome|Single Arm|"Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer~Cetuximab: Single arm phase II study of chemotherapy"
11364949|NCT01326923|EG000|Reported Event|Single Arm|"Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer~Cetuximab: Single arm phase II study of chemotherapy"
11364950|NCT01332799|BG000|Baseline|Allopurinol|allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
11364951|NCT01332799|BG001|Baseline|Placebo (Sugar Pill)|allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
11364952|NCT01332799|BG002|Baseline|Total|Total of all reporting groups
11364953|NCT01332799|FG000|Participant Flow|Allopurinol|allopurinol Daily active drug (allopurinol administered orally)
11364954|NCT01332799|FG001|Participant Flow|Placebo (Sugar Pill)|Placebo: Daily placebo (sugar pill) administered orally for 3 years.
11364955|NCT01332799|OG000|Outcome|Allopurinol|allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
11364956|NCT01332799|OG001|Outcome|Placebo (Sugar Pill)|allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
11364957|NCT01332799|EG000|Reported Event|Allopurinol|allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
11364958|NCT01332799|EG001|Reported Event|Placebo (Sugar Pill)|allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
11364959|NCT01329549|BG000|Baseline|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
11364960|NCT01329549|FG000|Participant Flow|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
11364961|NCT01329549|OG000|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
11364962|NCT01329549|EG000|Reported Event|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
11364963|NCT01326845|BG000|Baseline|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
11364964|NCT01326845|BG001|Baseline|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
11364965|NCT01326845|BG002|Baseline|Total|Total of all reporting groups
11364966|NCT01326845|FG000|Participant Flow|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
11364967|NCT01326845|FG001|Participant Flow|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
11364968|NCT01326845|OG000|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
11364969|NCT01326845|OG001|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
11364970|NCT01326845|EG000|Reported Event|ICL am|ICL am
11364971|NCT01326845|EG001|Reported Event|ICL pm|ICL pm
11364972|NCT01329341|BG000|Baseline|Service Dog|Veterans who received a service dog
11364973|NCT01329341|FG000|Participant Flow|Arm 1|"Service Dogs~Service Dogs: Service dogs will be trained to help Veterans with PTSD"
11364974|NCT01329341|OG000|Outcome|Service Dog|Veterans who received a service dog
11364975|NCT01329341|EG000|Reported Event|Service Dog|Veterans who received a service dog
11364976|NCT01319760|BG000|Baseline|Control|"Patients in the control arm will be treated with standard of care for post-PCI STEMI patients in accordance with the the 2004 ACC/AHA Guidelines for the Management of Patients with ST-elevation Myocardial Infarction.~Control: Standard care for STEMI patients post-PCI from ACC/AHA Guidelines"
11364977|NCT01319760|BG001|Baseline|Impella 2.5|"Patients in this arm will be treated in accordance with standard of care, and in addition will receive 24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.~Impella 2.5 support: Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5"
11364978|NCT01319760|BG002|Baseline|Total|Total of all reporting groups
11364979|NCT01319760|FG000|Participant Flow|Control (Standard of Care PCI Without Using Impella)|Patients in the control arm will be treated with standard of care for postPCI STEMI patients in accordance with the 2004 ACC/AHA Guidelines for the Management of Patients with STelevation Myocardia Infarction
11364980|NCT01319760|FG001|Participant Flow|Experimental (PCI Preceded With Impella 2.5)|"Patients in this arm will be treated in accordance with standard of care, and in addition will receive 24 hours of support with the Impella 2.5 postPCI for acute myocardial infarction.~Impella 2.5 support: Patients enrolled in the Impella arm will receive 24 hours of postPCI hemodynamic support using the Impella 2.5."
11364981|NCT01319760|OG000|Outcome|Treatment|
11364982|NCT01319760|OG000|Outcome|Roll In|Infarct size
11364983|NCT01319760|OG000|Outcome|Roll in|Study close in roll in phase. therefore, no comparison data available.
11364984|NCT01319760|EG000|Reported Event|Roll In|Study close in roll in phase. Therefore, no comparison data available.
11364985|NCT01320683|BG000|Baseline|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11364986|NCT01320683|FG000|Participant Flow|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11364987|NCT01320683|OG000|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11364988|NCT01320683|EG000|Reported Event|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11364989|NCT01313273|BG000|Baseline|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
11364990|NCT01313273|BG001|Baseline|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
11364991|NCT01313273|BG002|Baseline|Total|Total of all reporting groups
11364992|NCT01313273|FG000|Participant Flow|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.
11364993|NCT01313273|FG001|Participant Flow|Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
11364994|NCT01313273|OG000|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
11364995|NCT01313273|OG001|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
11364996|NCT01313273|EG000|Reported Event|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
11364997|NCT01313273|EG001|Reported Event|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
11364998|NCT01321008|BG000|Baseline|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
11364999|NCT01321008|FG000|Participant Flow|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
11365000|NCT01321008|OG000|Outcome|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
11365001|NCT01321008|EG000|Reported Event|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
11365002|NCT01310803|BG000|Baseline|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
11365003|NCT01310803|BG001|Baseline|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
11365004|NCT01310803|BG002|Baseline|Total|Total of all reporting groups
11365005|NCT01310803|FG000|Participant Flow|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
11365006|NCT01310803|FG001|Participant Flow|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
11365007|NCT01310803|OG000|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
11365008|NCT01310803|OG001|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
11365009|NCT01310803|EG000|Reported Event|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
11365010|NCT01310803|EG001|Reported Event|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
11365011|NCT01309581|BG000|Baseline|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
11365012|NCT01309581|BG001|Baseline|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
11189142|NCT02118337|FG005|Participant Flow|MEDI0680 20 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11365013|NCT01309581|BG002|Baseline|Total|Total of all reporting groups
11365014|NCT01309581|FG000|Participant Flow|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
11365015|NCT01309581|FG001|Participant Flow|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
11365016|NCT01309581|OG000|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
11365017|NCT01309581|OG001|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
11365018|NCT01309581|EG000|Reported Event|Ketamine|
11365019|NCT01309581|EG001|Reported Event|Methohexitol|
11365020|NCT01315873|BG000|Baseline|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
11365021|NCT01315873|FG000|Participant Flow|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
11365022|NCT01315873|OG000|Outcome|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
11189143|NCT02118337|FG006|Participant Flow|MEDI0680 20 mg/kg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189144|NCT02118337|FG007|Participant Flow|MEDI0680 20 mg/kg + Durvalumab 750 mg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11365023|NCT01315873|EG000|Reported Event|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
11365024|NCT01313923|BG000|Baseline|Sirolimus|All patient will be open-label; Sirolimus. Dosage is variable based on FDA guidelines.
11365025|NCT01313923|FG000|Participant Flow|Sirolimus|There is one arm to the study. All patients will be open-label, Sirolimus. There is no set dosage: medication dose will be based on FDA approved guidelines.
11365026|NCT01313923|OG000|Outcome|Sirolimus (Formerly Known as Rapamycin)|No results. Study has been terminated by investigator.
11365027|NCT01313923|EG000|Reported Event|Sirolimus (Formerly Known as Rapamycin)|No results as study has been terminated early by the investigator.
11365028|NCT01321697|BG000|Baseline|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
11365029|NCT01321697|FG000|Participant Flow|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
11365030|NCT01321697|OG000|Outcome|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
11365031|NCT01321697|EG000|Reported Event|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
11365032|NCT01312428|BG000|Baseline|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
11189145|NCT02118337|FG008|Participant Flow|Nivolumab 240 mg|Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11365033|NCT01312428|BG001|Baseline|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
11365034|NCT01312428|BG002|Baseline|Total|Total of all reporting groups
11365035|NCT01312428|FG000|Participant Flow|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL Group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
11189146|NCT02118337|OG000|Outcome|MEDI0680 0.1 mg/kg + Durvalumab 3 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
11189147|NCT02118337|OG001|Outcome|MEDI0680 0.1 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11365036|NCT01312428|FG001|Participant Flow|No PAL (No Pelvic Alignment Level)|"The cases randomized into the No PAL Group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
11365037|NCT01312428|OG000|Outcome|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
11365038|NCT01312428|OG001|Outcome|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
11365039|NCT01312428|OG000|Outcome|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL Group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
11365040|NCT01312428|OG001|Outcome|No PAL (No Pelvic Alignment Level)|"The cases randomized into the No PAL Group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
11365041|NCT01312428|EG000|Reported Event|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
11365042|NCT01312428|EG001|Reported Event|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
11365043|NCT01313416|BG000|Baseline|Single Arm|"Combination CT-011 and Gemcitabine~CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.~Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle."
11189148|NCT02118337|OG002|Outcome|MEDI0680 0.5 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11365044|NCT01313416|FG000|Participant Flow|Single Arm|"Combination CT-011 and Gemcitabine~CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.~Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle."
11365045|NCT01313416|OG000|Outcome|Single Arm|"Combination CT-011 and Gemcitabine~CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.~Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle."
11365046|NCT01313416|EG000|Reported Event|Single Arm|"Combination CT-011 and Gemcitabine~CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.~Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle."
11365047|NCT01303003|BG000|Baseline|Treatment Arm 1|"Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.~Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side."
11365048|NCT01303003|BG001|Baseline|Treatment Arm 2|"Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side~TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side"
11365049|NCT01303003|BG002|Baseline|Total|Total of all reporting groups
11365050|NCT01303003|FG000|Participant Flow|Treatment Arm 1|"Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.~Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side."
11365051|NCT01303003|FG001|Participant Flow|Treatment Arm 2|"Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side~TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side"
11365052|NCT01303003|OG000|Outcome|Treatment Arm 1|"Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.~Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side."
11365053|NCT01303003|OG001|Outcome|Treatment Arm 2|"Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side~TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side"
11365054|NCT01303003|EG000|Reported Event|Treatment Arm 1|"Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.~Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side."
11365055|NCT01303003|EG001|Reported Event|Treatment Arm 2|"Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side~TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side"
11365056|NCT01302444|BG000|Baseline|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
11365057|NCT01302444|BG001|Baseline|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
11365058|NCT01302444|BG002|Baseline|Total|Total of all reporting groups
11365059|NCT01302444|FG000|Participant Flow|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
11365060|NCT01302444|FG001|Participant Flow|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
11365061|NCT01302444|OG000|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
11365062|NCT01302444|OG001|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
11365063|NCT01302444|EG000|Reported Event|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
11365064|NCT01302444|EG001|Reported Event|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
11365065|NCT01301963|BG000|Baseline|Arm I|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
11365066|NCT01301963|BG001|Baseline|Arm II|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
11365067|NCT01301963|BG002|Baseline|Total|Total of all reporting groups
11365068|NCT01301963|FG000|Participant Flow|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
11365069|NCT01301963|FG001|Participant Flow|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
11365070|NCT01301963|OG000|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
11365071|NCT01301963|OG001|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
11365072|NCT01301963|EG000|Reported Event|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
11365073|NCT01301963|EG001|Reported Event|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
11365074|NCT01298921|BG000|Baseline|Continous Flow Oxygen|Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
11365075|NCT01298921|BG001|Baseline|Oxygen Demand Valve|Oxygen : A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate
11365076|NCT01298921|BG002|Baseline|Total|Total of all reporting groups
11365077|NCT01298921|FG000|Participant Flow|Continous Flow Oxygen|Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
11365078|NCT01298921|FG001|Participant Flow|Oxygen Demand Valve|Oxygen : A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate
11189149|NCT02118337|OG003|Outcome|MEDI0680 2.5 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11365079|NCT01298921|OG000|Outcome|Continous Flow Oxygen|Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
11189150|NCT02118337|OG004|Outcome|MEDI0680 10 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189151|NCT02118337|OG005|Outcome|MEDI0680 20 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189152|NCT02118337|OG000|Outcome|MEDI0680 20 mg/kg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189153|NCT02118337|OG001|Outcome|MEDI0680 20 mg/kg + Durvalumab 750 mg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189154|NCT02118337|OG002|Outcome|Nivolumab 240 mg|Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189155|NCT02118337|OG006|Outcome|MEDI0680 20 mg/kg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189156|NCT02118337|OG007|Outcome|MEDI0680 20 mg/kg + Durvalumab 750 mg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189157|NCT02118337|OG008|Outcome|Nivolumab 240 mg|Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189158|NCT02118337|OG006|Outcome|MEDI0680 20 mg/kg + Durvalumab 750 mg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189159|NCT02118337|EG000|Reported Event|MEDI0680 0.1 mg/kg + Durvalumab 3 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg Q2W for up to 12 months.
11189160|NCT02118337|EG001|Reported Event|MEDI0680 0.1 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189161|NCT02118337|EG002|Reported Event|MEDI0680 0.5 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189162|NCT02118337|EG003|Reported Event|MEDI0680 2.5 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189163|NCT02118337|EG004|Reported Event|MEDI0680 10 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189164|NCT02118337|EG005|Reported Event|MEDI0680 20 mg/kg + Durvalumab 10 mg|Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
11189165|NCT02118337|EG006|Reported Event|MEDI0680 20 mg/kg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189166|NCT02118337|EG007|Reported Event|MEDI0680 20 mg/kg + Durvalumab 750 mg|Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189167|NCT02118337|EG008|Reported Event|Nivolumab 240 mg|Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
11189168|NCT02118428|BG000|Baseline|Mirasol|"Transfusions with Mirasol-treated whole blood~Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood"
11189169|NCT02118428|BG001|Baseline|Control|"Transfusions with untreated whole blood~Untreated Whole Blood: Transfusion with fresh Whole Blood"
11189170|NCT02118428|BG002|Baseline|Total|Total of all reporting groups
11189171|NCT02118428|FG000|Participant Flow|Mirasol|"Transfusions with Mirasol-treated whole blood~Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood"
11189172|NCT02118428|FG001|Participant Flow|Control|"Transfusions with untreated whole blood~Untreated Whole Blood: Transfusion with fresh Whole Blood"
11189173|NCT02118428|FG002|Participant Flow|Unassigned|Enrolled subjects who became ineligible prior to randomization to either Mirasol or Control
11189174|NCT02118428|OG000|Outcome|Mirasol|"Transfusions with Mirasol-treated whole blood~Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood"
11189175|NCT02118428|OG001|Outcome|Control|"Transfusions with untreated whole blood~Untreated Whole Blood: Transfusion with fresh Whole Blood"
11365080|NCT01298921|OG001|Outcome|Oxygen Demand Valve|Oxygen : A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate
11365081|NCT01298921|OG000|Outcome|Continous Flow Oxygen|Oxygen: 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
11365082|NCT01298921|OG001|Outcome|Oxygen Demand Valve|Oxygen: A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate
11365083|NCT01298921|EG000|Reported Event|Continous Flow Oxygen|Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
11365084|NCT01298921|EG001|Reported Event|Oxygen Demand Valve|Oxygen : A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate
11365085|NCT01292070|BG000|Baseline|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
11365086|NCT01292070|FG000|Participant Flow|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
11365087|NCT01292070|OG000|Outcome|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
11365088|NCT01292070|EG000|Reported Event|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
11365089|NCT01292265|BG000|Baseline|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
11365090|NCT01292265|FG000|Participant Flow|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
11365091|NCT01292265|OG000|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
11365092|NCT01292265|EG000|Reported Event|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
11365093|NCT01290822|BG000|Baseline|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
11365094|NCT01290822|FG000|Participant Flow|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
11365095|NCT01290822|OG000|Outcome|All Subjects in the Study|This includes all subjects in the study
11365096|NCT01290822|EG000|Reported Event|All Subjects in the Study|This includes all subjects in the study
11365097|NCT01290718|BG000|Baseline|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
11365098|NCT01290718|FG000|Participant Flow|Capecitabine Plus (+) Trastuzumab|Participants received capecitabine 900 milligrams per square meter (mg/m^2) orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
11365099|NCT01290718|OG000|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
11365100|NCT01290718|EG000|Reported Event|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
11365101|NCT01293123|BG000|Baseline|Raltegravir|Raltegravir: raltegravir 400 mg PO twice daily
11365102|NCT01293123|BG001|Baseline|Efavirenz|Efavirenz: efavirenz 600 mg PO once daily
11365103|NCT01293123|BG002|Baseline|Total|Total of all reporting groups
11365104|NCT01293123|FG000|Participant Flow|Raltegravir|Raltegravir: raltegravir 400 mg PO twice daily
11365105|NCT01293123|FG001|Participant Flow|Efavirenz|Efavirenz: efavirenz 600 mg PO once daily
11365106|NCT01293123|OG000|Outcome|Raltegravir|Raltegravir: raltegravir 400 mg PO twice daily
11365107|NCT01293123|OG001|Outcome|Efavirenz|Efavirenz: efavirenz 600 mg PO once daily
11365108|NCT01293123|EG000|Reported Event|Raltegravir|Raltegravir: raltegravir 400 mg PO twice daily
10962731|NCT00868231|FG001|Participant Flow|Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
10962732|NCT00868231|FG002|Participant Flow|Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
10962733|NCT00868231|FG003|Participant Flow|Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
11189176|NCT02118428|EG000|Reported Event|Mirasol|"Transfusions with Mirasol-treated whole blood~Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood"
11365109|NCT01293123|EG001|Reported Event|Efavirenz|Efavirenz: efavirenz 600 mg PO once daily
11365110|NCT01294046|BG000|Baseline|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
11365111|NCT01294046|FG000|Participant Flow|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
11365112|NCT01294046|OG000|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
11365113|NCT01294046|OG000|Outcome|Experimental: Deep Brain Stimulation Arm Group|"Experimental: Deep brain stimulation arm group~Electrical Stimulation of SPG for Treatment of Migraine"
11365114|NCT01294046|OG000|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No outcome measure data was analyzed because no outcome data were collected."
11365115|NCT01294046|OG000|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
11189177|NCT02118428|EG001|Reported Event|Control|"Transfusions with untreated whole blood~Untreated Whole Blood: Transfusion with fresh Whole Blood"
11365116|NCT01294046|EG000|Reported Event|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
11365117|NCT01280643|BG000|Baseline|Arm A|"Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~fluorouracil: Given IV~leucovorin calcium: Given IV~irinotecan hydrochloride: Given IV~cetuximab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365118|NCT01280643|BG001|Baseline|Arm B|"Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~cetuximab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365119|NCT01280643|BG002|Baseline|Arm C|"Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15.~fluorouracil: Given IV~leucovorin calcium: Given IV~irinotecan hydrochloride: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365120|NCT01280643|BG003|Baseline|Arm D|"Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365121|NCT01280643|BG004|Baseline|Arm E|"Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~irinotecan hydrochloride: Given IV~cetuximab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365122|NCT01280643|BG005|Baseline|Arm F|"Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~oxaliplatin: Given IV~cetuximab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365123|NCT01280643|BG006|Baseline|ARM G|"Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1.~irinotecan hydrochloride: Given IV~bevacizumab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365124|NCT01280643|BG007|Baseline|Arm H|"Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1.~oxaliplatin: Given IV~bevacizumab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365125|NCT01280643|BG008|Baseline|Arm I|"Patients receive treatment as in Arm D.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365126|NCT01280643|BG009|Baseline|Total|Total of all reporting groups
11189178|NCT02118441|BG000|Baseline|Direct Palpation|"Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
11365127|NCT01280643|FG000|Participant Flow|Arm A|"Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~fluorouracil: Given IV~leucovorin calcium: Given IV~irinotecan hydrochloride: Given IV~cetuximab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365128|NCT01280643|FG001|Participant Flow|Arm B|"Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~cetuximab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365129|NCT01280643|FG002|Participant Flow|Arm C|"Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15.~fluorouracil: Given IV~leucovorin calcium: Given IV~irinotecan hydrochloride: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365130|NCT01280643|FG003|Participant Flow|Arm D|"Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365131|NCT01280643|FG004|Participant Flow|Arm E|"Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~irinotecan hydrochloride: Given IV~cetuximab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365132|NCT01280643|FG005|Participant Flow|Arm F|"Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~oxaliplatin: Given IV~cetuximab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365133|NCT01280643|FG006|Participant Flow|ARM G|"Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1.~irinotecan hydrochloride: Given IV~bevacizumab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365134|NCT01280643|FG007|Participant Flow|Arm H|"Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1.~oxaliplatin: Given IV~bevacizumab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365135|NCT01280643|FG008|Participant Flow|Arm I|"Patients receive treatment as in Arm D.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365136|NCT01280643|OG000|Outcome|Arm A|"Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~fluorouracil: Given IV~leucovorin calcium: Given IV~irinotecan hydrochloride: Given IV~cetuximab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365137|NCT01280643|OG001|Outcome|Arm B|"Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~cetuximab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365138|NCT01280643|OG002|Outcome|Arm C|"Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15.~fluorouracil: Given IV~leucovorin calcium: Given IV~irinotecan hydrochloride: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365139|NCT01280643|OG003|Outcome|Arm D|"Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365140|NCT01280643|OG004|Outcome|Arm E|"Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~irinotecan hydrochloride: Given IV~cetuximab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365141|NCT01280643|OG005|Outcome|Arm F|"Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~oxaliplatin: Given IV~cetuximab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365142|NCT01280643|OG006|Outcome|ARM G|"Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1.~irinotecan hydrochloride: Given IV~bevacizumab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365143|NCT01280643|OG007|Outcome|Arm H|"Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1.~oxaliplatin: Given IV~bevacizumab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365144|NCT01280643|OG008|Outcome|Arm I|"Patients receive treatment as in Arm D.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365145|NCT01280643|EG000|Reported Event|Arm A|"Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~fluorouracil: Given IV~leucovorin calcium: Given IV~irinotecan hydrochloride: Given IV~cetuximab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365146|NCT01280643|EG001|Reported Event|Arm B|"Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~cetuximab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365147|NCT01280643|EG002|Reported Event|Arm C|"Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15.~fluorouracil: Given IV~leucovorin calcium: Given IV~irinotecan hydrochloride: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365148|NCT01280643|EG003|Reported Event|Arm D|"Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365149|NCT01280643|EG004|Reported Event|Arm E|"Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~irinotecan hydrochloride: Given IV~cetuximab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365150|NCT01280643|EG005|Reported Event|Arm F|"Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.~oxaliplatin: Given IV~cetuximab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365151|NCT01280643|EG006|Reported Event|ARM G|"Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1.~irinotecan hydrochloride: Given IV~bevacizumab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365152|NCT01280643|EG007|Reported Event|Arm H|"Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1.~oxaliplatin: Given IV~bevacizumab: Given IV~capecitabine: Given PO~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11365153|NCT01280643|EG008|Reported Event|Arm I|"Patients receive treatment as in Arm D.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~bevacizumab: Given IV~mutation analysis: Correlative studies~gene expression analysis: Correlative studies~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~nucleic acid sequencing: Correlative studies~protein expression analysis: Correlative studies~polymerase chain reaction: Correlative studies~DNA analysis: Correlative studies"
11376274|NCT00980460|OG004|Outcome|High-risk Group (Regimen H)|"Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376275|NCT00980460|OG000|Outcome|Low-risk Group (Regimen T)|"Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376276|NCT00980460|OG001|Outcome|Intermediate-risk Group (Regimen F)|"Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)~Cisplatin: Given IV~Dexrazoxane: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11365154|NCT01281124|BG000|Baseline|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11365155|NCT01281124|FG000|Participant Flow|Treatment (5-Azacytidine)|Patients receive 5-azacitidine subcutaneously at the starting dose level of 75 mg/m2 on an outpatient basis daily for 7 days on a 28 day cycle.
11365156|NCT01281124|OG000|Outcome|Treatment (5-Azacyitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11365157|NCT01281124|OG000|Outcome|Treatment (5-Azacytidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11365158|NCT01281124|OG000|Outcome|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11365159|NCT01281124|EG000|Reported Event|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11365160|NCT01272141|BG000|Baseline|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
11365161|NCT01272141|FG000|Participant Flow|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
11365162|NCT01272141|OG000|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
11365163|NCT01272141|EG000|Reported Event|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
11365164|NCT01282216|BG000|Baseline|Donor Vaccine|Donors are randomized to receive either Havrix or PCV13 prior to bone marrow donation.
11365165|NCT01282216|BG001|Baseline|Recipient Vaccine|Recipients receive Havrix and PCV13 post bone marrow transplant.
11365166|NCT01282216|BG002|Baseline|Total|Total of all reporting groups
11365167|NCT01282216|FG000|Participant Flow|Donor PCV13|Donors receive PCV13 prior to bone marrow donation.
11365168|NCT01282216|FG001|Participant Flow|Donor Havrix|Donors receive Havrix prior to bone marrow donation.
11365169|NCT01282216|FG002|Participant Flow|Recipient Vaccine|Recipients receive Havrix and PCV13 post bone marrow transplant.
11365170|NCT01282216|FG003|Participant Flow|Donor - Assignment Unknown|Donors in this group received either PCV13 or Havrix. Assignment cannot be determined due to missing study data.
11365171|NCT01282216|OG000|Outcome|Donor Vaccine|Donors are randomized to receive either Havrix or PCV13 prior to bone marrow donation.
11365172|NCT01282216|OG001|Outcome|Recipient Vaccine|Recipients receive Havrix and PCV13 post bone marrow transplant.
11365173|NCT01282216|EG000|Reported Event|Donor Vaccine|Donors are randomized to receive either Havrix or PCV13 prior to bone marrow donation.
11365174|NCT01282216|EG001|Reported Event|Recipient Vaccine|Recipients receive Havrix and PCV13 post bone marrow transplant.
11365175|NCT01284491|BG000|Baseline|Total Study Population|
11365176|NCT01284491|FG000|Participant Flow|Total Study Population|
11365177|NCT01284491|OG000|Outcome|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
11365178|NCT01284491|OG001|Outcome|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11365179|NCT01284491|EG000|Reported Event|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
11365180|NCT01284491|EG001|Reported Event|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11365181|NCT01284504|BG000|Baseline|Celecoxib|"Celecoxib, 200 mg tab~Celecoxib: 200 mg tablet oral"
11365182|NCT01284504|BG001|Baseline|Placebo|"placebo, tab~placebo: Placebo, tab"
11365183|NCT01284504|BG002|Baseline|Total|Total of all reporting groups
11365184|NCT01284504|FG000|Participant Flow|Celocoxib|Celecoxib: 200 mg tablet oral
11365185|NCT01284504|FG001|Participant Flow|Placebo|"placebo~placebo"
11365186|NCT01284504|OG000|Outcome|Celocoxib|Celecoxib: 200 mg tablet oral
11365187|NCT01284504|OG001|Outcome|Placebo|"placebo~placebo"
11365188|NCT01284504|EG000|Reported Event|Celecoxib|"Celecoxib, 200 mg tab~Celecoxib: 200 mg tablet oral"
11365189|NCT01284504|EG001|Reported Event|Placebo|"placebo, tab~placebo: Placebo, tab"
11365190|NCT01269034|BG000|Baseline|Part A|"Exenatide and long acting insulin before the boost.~Exenatide: 1.25 mcg before the boost sub-cutaneously."
11365191|NCT01269034|BG001|Baseline|Part B|"Rapid and long acting insulin before the boost~Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs"
11365192|NCT01269034|BG002|Baseline|Part C|"long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost~long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs."
11365193|NCT01269034|BG003|Baseline|Healthy Controls|healthy controls without any medication before the boost.
11365194|NCT01269034|BG004|Baseline|Total|Total of all reporting groups
11365195|NCT01269034|FG000|Participant Flow|Part A|"Exenatide and long acting insulin before the boost.~Exenatide: 1.25 mcg before the boost sub-cutaneously."
11365196|NCT01269034|FG001|Participant Flow|Part B|"Rapid and long acting insulin before the boost~Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs"
11365197|NCT01269034|FG002|Participant Flow|Part C|"long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost~long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs."
11365198|NCT01269034|FG003|Participant Flow|Healthy Controls|healthy controls without any medication before the boost.
11365199|NCT01269034|OG000|Outcome|Part A|"Exenatide and long acting insulin before the boost.~Exenatide: 1.25 mcg before the boost sub-cutaneously."
11365200|NCT01269034|OG001|Outcome|Part B|"Rapid and long acting insulin before the boost~Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs"
11365201|NCT01269034|OG002|Outcome|Part C|"long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost~long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs."
11365202|NCT01269034|OG003|Outcome|Healthy Controls|healthy controls without any medication before the boost.
11365203|NCT01269034|EG000|Reported Event|Part A|"Exenatide and long acting insulin before the boost.~Exenatide: 1.25 mcg before the boost sub-cutaneously."
11365204|NCT01269034|EG001|Reported Event|Part B|"Rapid and long acting insulin before the boost~Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs"
11365205|NCT01269034|EG002|Reported Event|Part C|"long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost~long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs."
11365206|NCT01269034|EG003|Reported Event|Healthy Controls|healthy controls without any medication before the boost.
11365207|NCT01274533|BG000|Baseline|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
11365208|NCT01274533|FG000|Participant Flow|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
11365209|NCT01274533|OG000|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
11365210|NCT01274533|EG000|Reported Event|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
11365211|NCT01279616|BG000|Baseline|Hematopoietic Stem Cell Transplant|"Stem cell infusion on Day 0.~Fludarabine monophosphate: 180 mg/m2 over 6 days.~Rituximab: 375 mg/m2 on day -13 and day -3~Busulfan: AUC 1000-1200 microM.mt~ATG: 2.5 mg/kg for 3 days~Cyclophosphamide: 50 mg/kg on day +3~Mycophenolate mofetil: 15 mg/kg q 8 hours~Tacrolimus: 0.03 mg/kg /d"
11365212|NCT01279616|FG000|Participant Flow|Hematopoietic Stem Cell Transplant|"Drug: Fludarabine monophosphate 180 mg/m2 over 6 days.~Drug: Rituximab 375 mg/m2 on day -13 and day -3 Other Names: •Rituxan~Drug: Busulfan AUC 1000-1200 microM.mt Other Names: •busulfex~Drug: ATG 2.5 mg/kg for 3 days Other Names: •Thymoglobulin~Drug: Cyclophosphamide 50 mg/kg on day +3 Other Names: •Cytoxan~Drug: Mycophenolate mofetil 15 mg/kg q 8 hours Other Names: •MMF, Cell-cept.~Drug: Tacrolimus 0.03 mg/kg /d Other Names: •FK-506"
11365213|NCT01279616|OG000|Outcome|HSCT Transplant|HSCT transplant
11365214|NCT01279616|EG000|Reported Event|No Arm Analyzed: N/A|No outcome date are available for this study as the study was terminated. The PI has left the institution and cannot be contacted.
11365215|NCT01276054|BG000|Baseline|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
11365216|NCT01276054|BG001|Baseline|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
11365217|NCT01276054|BG002|Baseline|Total|Total of all reporting groups
11240123|NCT02476448|BG000|Baseline|Normal Saline|"Infused into the bladder to allow for visualization of bladder walls and urine jets.~Normal saline: Used to distend the bladder for cystoscopic evaluation"
11240124|NCT02476448|BG001|Baseline|Dextrose 10%|"Infused into the bladder to allow for visualization of bladder walls and colored urine jets.~Dextrose 10%: Used to distend the bladder for cystoscopic evaluation"
11240125|NCT02476448|BG002|Baseline|Phenazopyridine|"Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy.~Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy"
11365218|NCT01276054|FG000|Participant Flow|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
11365219|NCT01276054|FG001|Participant Flow|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
11365220|NCT01276054|OG000|Outcome|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
11365221|NCT01276054|OG001|Outcome|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
11365222|NCT01276054|EG000|Reported Event|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
11365223|NCT01276054|EG001|Reported Event|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
11365224|NCT01264965|BG000|Baseline|All Enrolled Patients|This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to.
11365225|NCT01264965|FG000|Participant Flow|All Enrolled Patients|This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to.
11365226|NCT01264965|OG000|Outcome|All Enrolled Patients|This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to.
11365227|NCT01264965|EG000|Reported Event|All Enrolled Patients|This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to.
11365228|NCT01266824|BG000|Baseline|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
11365229|NCT01266824|BG001|Baseline|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
11365230|NCT01266824|BG002|Baseline|Total|Total of all reporting groups
11365231|NCT01266824|FG000|Participant Flow|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
11365232|NCT01266824|FG001|Participant Flow|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
11240126|NCT02476448|BG003|Baseline|Sodium Fluorescein|"Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.~Sodium Fluorescein: Administered intravenously and assessed during cystoscopy"
11365233|NCT01266824|OG000|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
11365234|NCT01266824|OG001|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
11365235|NCT01266824|EG000|Reported Event|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
11240127|NCT02476448|BG004|Baseline|Total|Total of all reporting groups
11365236|NCT01266824|EG001|Reported Event|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
11365237|NCT01264835|BG000|Baseline|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
11365238|NCT01264835|FG000|Participant Flow|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
11365239|NCT01264835|OG000|Outcome|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
11365240|NCT01264835|EG000|Reported Event|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
11365241|NCT01274429|BG000|Baseline|Open Label Peanut Flour|"Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.~Peanut flour: Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose."
11365242|NCT01274429|FG000|Participant Flow|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
11365243|NCT01274429|OG000|Outcome|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
11365244|NCT01274429|EG000|Reported Event|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
11365245|NCT01273064|BG000|Baseline|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
11365246|NCT01273064|BG001|Baseline|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
11365247|NCT01273064|BG002|Baseline|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
11365248|NCT01273064|BG003|Baseline|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
11365249|NCT01273064|BG004|Baseline|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
11365250|NCT01273064|BG005|Baseline|Total|Total of all reporting groups
11365251|NCT01273064|FG000|Participant Flow|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
11365252|NCT01273064|FG001|Participant Flow|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
11365253|NCT01273064|FG002|Participant Flow|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
11365254|NCT01273064|FG003|Participant Flow|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
11365255|NCT01273064|FG004|Participant Flow|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
11365256|NCT01273064|OG000|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
11365257|NCT01273064|OG001|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
11365258|NCT01273064|OG002|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
11365259|NCT01273064|OG003|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
11365260|NCT01273064|OG004|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
11365261|NCT01273064|EG000|Reported Event|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
11365262|NCT01273064|EG001|Reported Event|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
11365263|NCT01273064|EG002|Reported Event|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
11365264|NCT01273064|EG003|Reported Event|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
11365265|NCT01273064|EG004|Reported Event|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
11365266|NCT01274559|BG000|Baseline|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
11365267|NCT01274559|BG001|Baseline|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
11365268|NCT01274559|BG002|Baseline|Total|Total of all reporting groups
11365269|NCT01274559|FG000|Participant Flow|Extended-release Niacin/Laropiprant|Extended-release niacin (ERN)/laropiprant (LRPT) 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
11365270|NCT01274559|FG001|Participant Flow|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
11365271|NCT01274559|OG000|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
11365272|NCT01274559|OG001|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
11365273|NCT01274559|EG000|Reported Event|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
11365274|NCT01274559|EG001|Reported Event|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
11365275|NCT01270581|BG000|Baseline|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
11365276|NCT01270581|BG001|Baseline|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
11365277|NCT01270581|BG002|Baseline|Total|Total of all reporting groups
11365278|NCT01270581|FG000|Participant Flow|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
11365279|NCT01270581|FG001|Participant Flow|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
11365280|NCT01270581|OG000|Outcome|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
11365281|NCT01270581|OG001|Outcome|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
11365282|NCT01270581|EG000|Reported Event|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
11365283|NCT01270581|EG001|Reported Event|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
11365284|NCT01269749|BG000|Baseline|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
11365285|NCT01269749|BG001|Baseline|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
11365286|NCT01269749|BG002|Baseline|Total|Total of all reporting groups
11365287|NCT01269749|FG000|Participant Flow|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
11365288|NCT01269749|FG001|Participant Flow|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
11365289|NCT01269749|OG000|Outcome|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
11365290|NCT01269749|OG001|Outcome|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
11240128|NCT02476448|FG000|Participant Flow|Normal Saline|"Infused into the bladder to allow for visualization of bladder walls and urine jets.~Normal saline: Used to distend the bladder for cystoscopic evaluation"
11365291|NCT01269749|EG000|Reported Event|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
11365292|NCT01269749|EG001|Reported Event|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
11365293|NCT01270919|BG000|Baseline|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
11365294|NCT01270919|FG000|Participant Flow|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
11365295|NCT01270919|OG000|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
11365296|NCT01270919|EG000|Reported Event|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
11365297|NCT01262339|BG000|Baseline|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject's hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
11365298|NCT01262339|FG000|Participant Flow|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject's hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
11365299|NCT01262339|OG000|Outcome|Active Comparator: Comparator of Hand A Intervention vs Hand B|Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
11365300|NCT01262339|EG000|Reported Event|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject's hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
11365301|NCT01267825|BG000|Baseline|CT-guided Intervention|"CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care~CT-guided corticosteroid+ bupivicaine: CT-guided corticosteroid+ bupivicaine Also get standard medical care"
11365302|NCT01267825|BG001|Baseline|Standard Medical Care|Standard medical care: Naproxen + Oxycodone/ Acetaminophen
11365303|NCT01267825|BG002|Baseline|Total|Total of all reporting groups
11365304|NCT01267825|FG000|Participant Flow|CT-guided Intervention|"CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care~CT-guided corticosteroid+ bupivicaine: CT-guided corticosteroid+ bupivicaine Also get standard medical care"
11365305|NCT01267825|FG001|Participant Flow|Standard Medical Care|Standard medical care: Naproxen + Oxycodone/ Acetaminophen
11365306|NCT01267825|OG000|Outcome|CT-guided Intervention|"CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care~CT-guided corticosteroid+ bupivicaine: CT-guided corticosteroid+ bupivicaine Also get standard medical care"
11365307|NCT01267825|OG001|Outcome|Standard Medical Care|Standard medical care: Naproxen + Oxycodone/ Acetaminophen
11365308|NCT01267825|EG000|Reported Event|CT-guided Intervention|"CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care~CT-guided corticosteroid+ bupivicaine: CT-guided corticosteroid+ bupivicaine Also get standard medical care"
11365309|NCT01267825|EG001|Reported Event|Standard Medical Care|Standard medical care: Naproxen + Oxycodone/ Acetaminophen
11365310|NCT01259284|BG000|Baseline|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
11365311|NCT01259284|BG001|Baseline|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
11365312|NCT01259284|BG002|Baseline|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
11365313|NCT01259284|BG003|Baseline|Total|Total of all reporting groups
11365314|NCT01259284|FG000|Participant Flow|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
11365315|NCT01259284|FG001|Participant Flow|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
11365316|NCT01259284|FG002|Participant Flow|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
11365317|NCT01259284|OG000|Outcome|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
11365318|NCT01259284|OG001|Outcome|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
11365319|NCT01259284|OG002|Outcome|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
11240129|NCT02476448|FG001|Participant Flow|Dextrose 10%|"Infused into the bladder to allow for visualization of bladder walls and colored urine jets.~Dextrose 10%: Used to distend the bladder for cystoscopic evaluation"
11365320|NCT01259284|EG000|Reported Event|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
11365321|NCT01259284|EG001|Reported Event|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
11365322|NCT01259284|EG002|Reported Event|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
11365323|NCT01249157|BG000|Baseline|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer.The first 5 patients who consent to the study will be intended for training purposes only.
11365324|NCT01249157|FG000|Participant Flow|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
11365325|NCT01249157|OG000|Outcome|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
11365326|NCT01249157|EG000|Reported Event|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
11365327|NCT01263028|BG000|Baseline|Ergocalciferol Supplementation|
11365328|NCT01263028|FG000|Participant Flow|Ergocalciferol Supplementation|
11365329|NCT01263028|OG000|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
11365330|NCT01263028|EG000|Reported Event|Ergocalciferol Supplementation|
11365331|NCT01256281|BG000|Baseline|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
11365332|NCT01256281|FG000|Participant Flow|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
11365333|NCT01256281|OG000|Outcome|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
11365334|NCT01256281|EG000|Reported Event|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
11365335|NCT01253668|BG000|Baseline|Arm 1|"Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.~Brivanib alaninate: Brivanib by mouth daily at a dose of 800mg.~Polymerase chain reaction: Undergo 1241-cG250 PET/CT imaging (correlative studies)~Iodine I 124 chimeric monoclonal antibody G250: Undergo 124I-cG250 PET/CT imaging (correlative studies)~Positron emission tomography/computed tomography: Undergo 1241-cG250 PET/CT imaging (correlative studies)~Protein expression analysis: Correlative studies~Immunohistochemistry: correlative studies"
11365336|NCT01253668|FG000|Participant Flow|Arm 1|"Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.~Brivanib alaninate: Brivanib by mouth daily at a dose of 800mg.~Polymerase chain reaction: Undergo 1241-cG250 PET/CT imaging (correlative studies)~Iodine I 124 chimeric monoclonal antibody G250: Undergo 124I-cG250 PET/CT imaging (correlative studies)~Positron emission tomography/computed tomography: Undergo 1241-cG250 PET/CT imaging (correlative studies)~Protein expression analysis: Correlative studies~Immunohistochemistry: correlative studies"
11365337|NCT01253668|OG000|Outcome|Arm 1|"Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.~Brivanib alaninate: Brivanib by mouth daily at a dose of 800mg.~Polymerase chain reaction: Undergo 1241-cG250 PET/CT imaging (correlative studies)~Iodine I 124 chimeric monoclonal antibody G250: Undergo 124I-cG250 PET/CT imaging (correlative studies)~Positron emission tomography/computed tomography: Undergo 1241-cG250 PET/CT imaging (correlative studies)~Protein expression analysis: Correlative studies~Immunohistochemistry: correlative studies"
11365338|NCT01253668|EG000|Reported Event|Arm 1|"Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.~Brivanib alaninate: Brivanib by mouth daily at a dose of 800mg.~Polymerase chain reaction: Undergo 1241-cG250 PET/CT imaging (correlative studies)~Iodine I 124 chimeric monoclonal antibody G250: Undergo 124I-cG250 PET/CT imaging (correlative studies)~Positron emission tomography/computed tomography: Undergo 1241-cG250 PET/CT imaging (correlative studies)~Protein expression analysis: Correlative studies~Immunohistochemistry: correlative studies"
11365339|NCT01259024|BG000|Baseline|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
11365340|NCT01259024|FG000|Participant Flow|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
11365341|NCT01259024|OG000|Outcome|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
11365342|NCT01259024|EG000|Reported Event|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
11365343|NCT01251952|BG000|Baseline|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
11240130|NCT02476448|FG002|Participant Flow|Phenazopyridine|"Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy.~Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy"
11365344|NCT01251952|FG000|Participant Flow|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
11365345|NCT01251952|OG000|Outcome|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
11365346|NCT01251952|EG000|Reported Event|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
11365347|NCT01251120|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)
11365348|NCT01251120|BG001|Baseline|Placebo|Participants received Non-biologic DMARDs (including methotrexate) according to current best practice
11365349|NCT01251120|BG002|Baseline|Total|Total of all reporting groups
11365350|NCT01251120|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously every 4 weeks along with background disease-modifying antirheumatic drugs (DMARDs) including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
11365351|NCT01251120|FG001|Participant Flow|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
11365352|NCT01251120|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
11365353|NCT01251120|OG001|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
11365354|NCT01251120|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
11365355|NCT01251120|EG001|Reported Event|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
11365356|NCT01248130|BG000|Baseline|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
11365357|NCT01248130|BG001|Baseline|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
11365358|NCT01248130|BG002|Baseline|Total|Total of all reporting groups
11365359|NCT01248130|FG000|Participant Flow|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
11365360|NCT01248130|FG001|Participant Flow|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
11365361|NCT01248130|OG000|Outcome|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
11189179|NCT02118441|BG001|Baseline|Ultrasound|"Radial artery catheter insertion will be conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer will be used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) will be used. Colour flow doppler may also be used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
11189180|NCT02118441|BG002|Baseline|Total|Total of all reporting groups
11365362|NCT01248130|OG001|Outcome|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
11365363|NCT01248130|EG000|Reported Event|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
11365364|NCT01248130|EG001|Reported Event|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
11365365|NCT01243892|BG000|Baseline|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
11365366|NCT01243892|BG001|Baseline|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
11365367|NCT01243892|BG002|Baseline|Total|Total of all reporting groups
11365368|NCT01243892|FG000|Participant Flow|IGHD Participants|Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
11365369|NCT01243892|FG001|Participant Flow|ISS Participants|Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
11365370|NCT01243892|OG000|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
11365371|NCT01243892|OG001|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
11365372|NCT01243892|EG000|Reported Event|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
11365373|NCT01243892|EG001|Reported Event|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.
11365374|NCT01246011|BG000|Baseline|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
11365375|NCT01246011|BG001|Baseline|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
11365376|NCT01246011|BG002|Baseline|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
11365377|NCT01246011|BG003|Baseline|Total|Total of all reporting groups
11365378|NCT01246011|FG000|Participant Flow|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
11365379|NCT01246011|FG001|Participant Flow|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
11365380|NCT01246011|FG002|Participant Flow|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
11189181|NCT02118441|FG000|Participant Flow|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
11189182|NCT02118441|FG001|Participant Flow|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
11189183|NCT02118441|OG000|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
11189184|NCT02118441|OG001|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
11189185|NCT02118441|OG001|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
11189186|NCT02118441|EG000|Reported Event|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
11189187|NCT02118441|EG001|Reported Event|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
11189188|NCT02118597|BG000|Baseline|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
11189189|NCT02118597|FG000|Participant Flow|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
11189190|NCT02118597|OG000|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
11189191|NCT02118597|EG000|Reported Event|Triple Combination Therapy|Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (Peg-interferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peg-interferon alfa-2a and ribavirin were observed.
11189192|NCT02118714|BG000|Baseline|Atrasentan|Atrasentan 0.75 mg administered orally once daily (QD).
11189193|NCT02118714|FG000|Participant Flow|Atrasentan|Atrasentan 0.75 mg administered orally once daily (QD).
11189194|NCT02118714|OG000|Outcome|Atrasentan|Atrasentan 0.75 mg administered orally once daily (QD).
11189195|NCT02118714|EG000|Reported Event|Atrasentan|Atrasentan 0.75 mg administered orally once daily (QD).
11189196|NCT02118766|BG000|Baseline|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
11189197|NCT02118766|BG001|Baseline|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
11365381|NCT01246011|OG000|Outcome|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
11189198|NCT02118766|BG002|Baseline|Total|Total of all reporting groups
11189199|NCT02118766|FG000|Participant Flow|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
11189200|NCT02118766|FG001|Participant Flow|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
11189201|NCT02118766|OG000|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
11189202|NCT02118766|OG001|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
11365382|NCT01246011|OG001|Outcome|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
11365383|NCT01246011|OG002|Outcome|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
11365384|NCT01246011|OG000|Outcome|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|"Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin~Argatroban and warfarin: Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month."
11365385|NCT01246011|EG000|Reported Event|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
11365386|NCT01246011|EG001|Reported Event|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
11365387|NCT01246011|EG002|Reported Event|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
11365388|NCT01242020|BG000|Baseline|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
11365389|NCT01242020|BG001|Baseline|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
11365390|NCT01242020|BG002|Baseline|Total|Total of all reporting groups
11365391|NCT01242020|FG000|Participant Flow|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
11365392|NCT01242020|FG001|Participant Flow|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
11365393|NCT01242020|OG000|Outcome|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
11365394|NCT01242020|OG001|Outcome|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
11365395|NCT01242020|EG000|Reported Event|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
11365396|NCT01242020|EG001|Reported Event|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
11365397|NCT01244620|BG000|Baseline|Entire Study Population|All randomized participants
11365398|NCT01244620|FG000|Participant Flow|Sitax, Then Tad, Then Sitax and Tad, Then Sitax and Sild|Sitaxsentan 100 milligram (mg) tablet once daily (QD) for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table three times daily (TID) for 6 days. Only the first treatment in the sequence was administered due to the early termination.
11365399|NCT01244620|FG001|Participant Flow|Tad, Then Sitax and Sild, Then Sitax, Then Sitax and Tad|Tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
11189203|NCT02118766|EG000|Reported Event|Crisaborole (AN2728) Ointment, 2 Percent|Participants with mild to moderate AD applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
11365400|NCT01244620|FG002|Participant Flow|Sitax and Tad, Then Sitax, Then Sitax and Sild, Then Tad|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
11365401|NCT01244620|FG003|Participant Flow|Sitax and Sild, Then Sitax and Tad, Then Tad, Then Sitax|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
11365402|NCT01244620|OG000|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
11365403|NCT01244620|OG001|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
11365404|NCT01244620|OG002|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
11365405|NCT01244620|OG003|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
11365406|NCT01244620|EG000|Reported Event|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days
11365407|NCT01244620|EG001|Reported Event|Tadalafil|Tadalafil 40 mg tablet QD for 6 days
11365408|NCT01244620|EG002|Reported Event|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days
11365409|NCT01244620|EG003|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days
11365410|NCT01240304|BG000|Baseline|Gemcitabine, Radiation Therapy, Surgery|"Alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.~Radiation therapy: The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the convention"
11365411|NCT01240304|FG000|Participant Flow|Gemcitabine, Radiation Therapy, Surgery|"Alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.~Radiation therapy: The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the convention"
11365412|NCT01240304|OG000|Outcome|Gemcitabine, Radiation Therapy, Surgery|"Alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.~Radiation therapy: The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the convention"
11365413|NCT01240304|EG000|Reported Event|Gemcitabine, Radiation Therapy, Surgery|"Alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.~Radiation therapy: The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the convention"
11365414|NCT01241279|BG000|Baseline|Crystalens AO|A silicone multi-piece accommodating intraocular lens
11365415|NCT01241279|BG001|Baseline|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
11365416|NCT01241279|BG002|Baseline|Total|Total of all reporting groups
11365417|NCT01241279|FG000|Participant Flow|Crystalens AO|A silicone multi-piece accommodating intraocular lens
11365418|NCT01241279|FG001|Participant Flow|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
11365419|NCT01241279|OG000|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
11365420|NCT01241279|OG001|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
11365421|NCT01241279|EG000|Reported Event|Crystalens AO|A silicone multi-piece accommodating intraocular lens
11365422|NCT01241279|EG001|Reported Event|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
11365423|NCT01230788|BG000|Baseline|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
11365424|NCT01230788|FG000|Participant Flow|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
11365425|NCT01230788|OG000|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
11365426|NCT01230788|EG000|Reported Event|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
11365427|NCT01239680|BG000|Baseline|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours
11365428|NCT01239680|BG001|Baseline|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
11365429|NCT01239680|BG002|Baseline|Total|Total of all reporting groups
11365430|NCT01239680|FG000|Participant Flow|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate Intravenous 1 liter once over 6 hours
11365431|NCT01239680|FG001|Participant Flow|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
11365432|NCT01239680|OG000|Outcome|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
11365433|NCT01239680|OG001|Outcome|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
11365434|NCT01239680|EG000|Reported Event|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
11365435|NCT01239680|EG001|Reported Event|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
11365436|NCT01237613|BG000|Baseline|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
11365437|NCT01237613|FG000|Participant Flow|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
11365438|NCT01237613|OG000|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
11365439|NCT01237613|OG000|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patientschronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
11365440|NCT01237613|EG000|Reported Event|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
11365441|NCT01234103|BG000|Baseline|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
11365442|NCT01234103|BG001|Baseline|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
11365443|NCT01234103|BG002|Baseline|Total|Total of all reporting groups
11365444|NCT01234103|FG000|Participant Flow|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
11365445|NCT01234103|FG001|Participant Flow|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
11365446|NCT01234103|OG000|Outcome|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
11365447|NCT01234103|OG001|Outcome|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
11189204|NCT02118766|EG001|Reported Event|Crisaborole (AN2728) Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
11365448|NCT01234103|EG000|Reported Event|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
11365449|NCT01234103|EG001|Reported Event|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
11365450|NCT01231750|BG000|Baseline|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
11365451|NCT01231750|BG001|Baseline|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
11365452|NCT01231750|BG002|Baseline|Total|Total of all reporting groups
11365453|NCT01231750|FG000|Participant Flow|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
11365454|NCT01231750|FG001|Participant Flow|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
11365455|NCT01231750|OG000|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
11365456|NCT01231750|OG001|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
11365457|NCT01231750|EG000|Reported Event|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
11365458|NCT01231750|EG001|Reported Event|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
11365459|NCT01230307|BG000|Baseline|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
11365460|NCT01230307|BG001|Baseline|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
11365461|NCT01230307|BG002|Baseline|Total|Total of all reporting groups
11365462|NCT01230307|FG000|Participant Flow|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
11365463|NCT01230307|FG001|Participant Flow|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
11365464|NCT01230307|OG000|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
11365465|NCT01230307|OG001|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
11365466|NCT01230307|EG000|Reported Event|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
11365467|NCT01230307|EG001|Reported Event|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
11365468|NCT01230489|BG000|Baseline|Surgical Catheter Dressings|Participants randomized to either standard of care dressings or Medihoney dressings to catheter exit sites. The numbers allocated to each arm is unknown. Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
11365469|NCT01230489|FG000|Participant Flow|Surgical Catheter Dressings|"Participants were randomized to receive either a standard of care dressing to their surgical wound catheter exit site or the MediHoney dressing.~Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments."
11365470|NCT01230489|OG000|Outcome|Surgical Catheter Dressings|Participants randomized to either standard of care dressings or Medihoney dressings to catheter exit sites.It is not known how many were assigned to each arm.
11365471|NCT01230489|EG000|Reported Event|Surgical Catheter Dressings|Participants randomized to either standard of care dressings or Medihoney dressings to catheter exit sites. Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
11365472|NCT01222871|BG000|Baseline|Triamcinolone|Nasopore Triamcinolone soaked sponge
11365473|NCT01222871|BG001|Baseline|Control|Saline Soaked sponge
11365474|NCT01222871|BG002|Baseline|Total|Total of all reporting groups
11365475|NCT01222871|FG000|Participant Flow|Triamcinolone|Nasopore Triamcinolone soaked sponge
11365476|NCT01222871|FG001|Participant Flow|Control|Saline soaked sponge
11365477|NCT01222871|OG000|Outcome|Triamcinolone|Nasopore Triamcinolone soaked sponge
11365478|NCT01222871|OG001|Outcome|Control|Saline soaked sponge
11365479|NCT01222871|EG000|Reported Event|Triamcinolone|Nasopore Triamcinolone soaked sponge
11365480|NCT01222871|EG001|Reported Event|Saline Soaked Sponge|Nasopore saline soaked sponge
11365481|NCT01222871|EG002|Reported Event|Control|Saline soaked sponge
11365482|NCT01219673|BG000|Baseline|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
11365483|NCT01219673|BG001|Baseline|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
11365484|NCT01219673|BG002|Baseline|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
11365485|NCT01219673|BG003|Baseline|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
11365486|NCT01219673|BG004|Baseline|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
11365487|NCT01219673|BG005|Baseline|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
11365488|NCT01219673|BG006|Baseline|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
11365489|NCT01219673|BG007|Baseline|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
11365490|NCT01219673|BG008|Baseline|Total|Total of all reporting groups
11365491|NCT01219673|FG000|Participant Flow|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
11365492|NCT01219673|FG001|Participant Flow|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
11365493|NCT01219673|FG002|Participant Flow|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
11365494|NCT01219673|FG003|Participant Flow|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
11365495|NCT01219673|FG004|Participant Flow|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
11365496|NCT01219673|FG005|Participant Flow|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
11365497|NCT01219673|FG006|Participant Flow|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
11365498|NCT01219673|FG007|Participant Flow|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
11365499|NCT01219673|OG000|Outcome|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
11365500|NCT01219673|OG001|Outcome|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
11365501|NCT01219673|OG002|Outcome|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
11365502|NCT01219673|OG003|Outcome|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
11365503|NCT01219673|OG004|Outcome|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
11365504|NCT01219673|OG005|Outcome|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
11365505|NCT01219673|OG006|Outcome|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
11365506|NCT01219673|OG007|Outcome|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
11365507|NCT01219673|EG000|Reported Event|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
11365508|NCT01219673|EG001|Reported Event|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
11365509|NCT01219673|EG002|Reported Event|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
11365510|NCT01219673|EG003|Reported Event|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
11365511|NCT01219673|EG004|Reported Event|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
11365512|NCT01219673|EG005|Reported Event|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
11365513|NCT01219673|EG006|Reported Event|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
11365514|NCT01219673|EG007|Reported Event|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
11365515|NCT01223001|BG000|Baseline|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
11365516|NCT01223001|BG001|Baseline|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
11365517|NCT01223001|BG002|Baseline|Total|Total of all reporting groups
11365518|NCT01223001|FG000|Participant Flow|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
11365519|NCT01223001|FG001|Participant Flow|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
11365520|NCT01223001|OG000|Outcome|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
11365521|NCT01223001|OG001|Outcome|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
11365522|NCT01223001|EG000|Reported Event|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
11365523|NCT01223001|EG001|Reported Event|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
11365524|NCT01217060|BG000|Baseline|Docetaxel + 5-FU + Radiation + Surgery|Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
11365525|NCT01217060|FG000|Participant Flow|Docetaxel + 5-FU + Radiation + Surgery|Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
11365526|NCT01217060|OG000|Outcome|Docetaxel + 5-FU + Radiation + Surgery|Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
11365527|NCT01217060|EG000|Reported Event|Docetaxel + 5-FU + Radiation + Surgery|Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
11365528|NCT01217047|BG000|Baseline|Group A|"For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365529|NCT01217047|BG001|Baseline|Group B|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11376277|NCT00980460|OG002|Outcome|High-risk Group (Regimen W)|"(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11365530|NCT01217047|BG002|Baseline|Group C|"For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365531|NCT01217047|BG003|Baseline|Group D|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.~Cycling without FES: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365532|NCT01217047|BG004|Baseline|Total|Total of all reporting groups
11365533|NCT01217047|FG000|Participant Flow|Group A|"For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365534|NCT01217047|FG001|Participant Flow|Group B|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365535|NCT01217047|FG002|Participant Flow|Group C|"For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11189205|NCT02118792|BG000|Baseline|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11365536|NCT01217047|OG000|Outcome|Group A|"For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365537|NCT01217047|OG001|Outcome|Group B|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365538|NCT01217047|OG002|Outcome|Group C|"For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365539|NCT01217047|OG003|Outcome|Group D|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.~Cycling without FES: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11377072|NCT00346164|EG003|Reported Event|Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
10849896|NCT00299130|OG001|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11189206|NCT02118792|BG001|Baseline|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11189207|NCT02118792|BG002|Baseline|Total|Total of all reporting groups
11365540|NCT01217047|EG000|Reported Event|Group A|"For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365541|NCT01217047|EG001|Reported Event|Group B|"For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365542|NCT01217047|EG002|Reported Event|Group C|"For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.~FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.~Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).~Mood assessment: If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
11365543|NCT01206101|BG000|Baseline|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
11365544|NCT01206101|BG001|Baseline|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
11365545|NCT01206101|BG002|Baseline|Total|Total of all reporting groups
11365546|NCT01206101|FG000|Participant Flow|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
11365547|NCT01206101|FG001|Participant Flow|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
11365548|NCT01206101|OG000|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
11365549|NCT01206101|OG001|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
11365550|NCT01206101|EG000|Reported Event|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
11365551|NCT01206101|EG001|Reported Event|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
11365552|NCT01216631|BG000|Baseline|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
11365553|NCT01216631|BG001|Baseline|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
11377073|NCT00972179|BG000|Baseline|Tezepelumab 35 mg Q28D|Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
11365554|NCT01216631|BG002|Baseline|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
11365555|NCT01216631|BG003|Baseline|Total|Total of all reporting groups
11365556|NCT01216631|FG000|Participant Flow|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
11365557|NCT01216631|FG001|Participant Flow|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
11365558|NCT01216631|FG002|Participant Flow|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
11365559|NCT01216631|OG000|Outcome|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
11365560|NCT01216631|OG001|Outcome|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
11365561|NCT01216631|OG002|Outcome|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
11365562|NCT01216631|EG000|Reported Event|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
11365563|NCT01216631|EG001|Reported Event|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
11365564|NCT01216631|EG002|Reported Event|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
11189208|NCT02118792|FG000|Participant Flow|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable atopic dermatitis (AD)-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11365565|NCT01211756|BG000|Baseline|All Participants|As there was only one subject enrolled, the results will not be analyzed.
11365566|NCT01211756|FG000|Participant Flow|All Participants|As there was only one subject enrolled, the results will not be analyzed.
11365567|NCT01211756|OG000|Outcome|All Participants|As there was only one subject enrolled, the results will not be analyzed.
11365568|NCT01211756|EG000|Reported Event|All Participants|As there was only one subject enrolled, the results will not be analyzed.
11365569|NCT01209520|BG000|Baseline|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
11365570|NCT01209520|FG000|Participant Flow|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
11365571|NCT01209520|OG000|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
11189209|NCT02118792|FG001|Participant Flow|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11189210|NCT02118792|OG000|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11377074|NCT00972179|BG001|Baseline|Tezepelumab 105 mg Q28D|Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
11377075|NCT00972179|BG002|Baseline|Tezepelumab 210 mg Q28D|Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
11377076|NCT00972179|BG003|Baseline|Tezepelumab 210 mg Q14D|Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
11365572|NCT01209520|EG000|Reported Event|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
11365573|NCT01207726|BG000|Baseline|Azacitidine SC and Entinostat PO|Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Followed by Cytotoxic Therapy investigator Choice
11365574|NCT01207726|BG001|Baseline|Cytotoxic Therapy|Standard of care
11365575|NCT01207726|BG002|Baseline|Total|Total of all reporting groups
11365576|NCT01207726|FG000|Participant Flow|Azacitidine SC and Entinostat Oral|Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11365577|NCT01207726|FG001|Participant Flow|Chemotherapy Alone|Standard of care chemotherapy
11365578|NCT01207726|OG000|Outcome|Arm I (Azacitidine, Entinostat)|"Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11365579|NCT01207726|OG001|Outcome|Arm II (Standard of Care)|Patients receive standard of care.
11365580|NCT01207726|OG000|Outcome|Azacitidine SC and Entinostat Oral|Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11365581|NCT01207726|OG001|Outcome|Chemotherapy Alone|Standard of care chemotherapy
11365582|NCT01207726|OG000|Outcome|Azacitidine SC and Entinostat PO|Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Followed by Cytotoxic Therapy investigator Choice
11365583|NCT01207726|OG001|Outcome|Cytotoxic Therapy|Standard of care
11365584|NCT01207726|EG000|Reported Event|Azacitidine SC and Entinostat PO|Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11365585|NCT01207726|EG001|Reported Event|Cytotoxic Chemotherapy|Investigators Choice Chemotherapy
11365586|NCT01206296|BG000|Baseline|Intraperitoneal Gemcitabine|"Intraperitoneal Gemcitabine~Intraperitoneal Gemcitabine: Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2~Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles"
11365587|NCT01206296|FG000|Participant Flow|Intraperitoneal Gemcitabine|"Intraperitoneal Gemcitabine~Intraperitoneal Gemcitabine: Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2~Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles"
11365588|NCT01206296|OG000|Outcome|Intraperitoneal Gemcitabine|"Intraperitoneal Gemcitabine~Intraperitoneal Gemcitabine: Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2~Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles"
11365589|NCT01206296|EG000|Reported Event|Intraperitoneal Gemcitabine|"Intraperitoneal Gemcitabine~Intraperitoneal Gemcitabine: Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2~Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles"
11365590|NCT01207102|BG000|Baseline|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
11365591|NCT01207102|FG000|Participant Flow|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
11365592|NCT01207102|OG000|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
11365593|NCT01207102|EG000|Reported Event|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
11365594|NCT01213329|BG000|Baseline|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
11365595|NCT01213329|BG001|Baseline|Donor Comparison|
11365596|NCT01213329|BG002|Baseline|Total|Total of all reporting groups
11365597|NCT01213329|FG000|Participant Flow|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
11365598|NCT01213329|FG001|Participant Flow|Donor Comparison|
11365599|NCT01213329|OG000|Outcome|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
11365600|NCT01213329|OG000|Outcome|Donor Comparison|The donor group served as source of PBMCs to use as stimulator for the patients that received Alemtuzumab.
11365601|NCT01213329|EG000|Reported Event|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
11365602|NCT01213329|EG001|Reported Event|Donor Comparison|
11365603|NCT01202110|BG000|Baseline|Control|Control
11365604|NCT01202110|FG000|Participant Flow|Control|Control
11365605|NCT01202110|FG001|Participant Flow|Propranolol|Propranolol
11365606|NCT01202110|OG000|Outcome|Propranolol|0
11365607|NCT01202110|EG000|Reported Event|Control|10
11365608|NCT01206439|BG000|Baseline|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
11365609|NCT01206439|FG000|Participant Flow|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
11365610|NCT01206439|OG000|Outcome|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
11365611|NCT01206439|EG000|Reported Event|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
11365612|NCT01204788|BG000|Baseline|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
11365613|NCT01204788|BG001|Baseline|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
11365614|NCT01204788|BG002|Baseline|Total|Total of all reporting groups
11365615|NCT01204788|FG000|Participant Flow|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
11365616|NCT01204788|FG001|Participant Flow|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
11365617|NCT01204788|OG000|Outcome|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
11365618|NCT01204788|OG001|Outcome|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
11365619|NCT01204788|EG000|Reported Event|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
11365620|NCT01204788|EG001|Reported Event|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
11365621|NCT01200602|BG000|Baseline|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
11365622|NCT01200602|BG001|Baseline|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
11365623|NCT01200602|BG002|Baseline|Total|Total of all reporting groups
11365624|NCT01200602|FG000|Participant Flow|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
11365625|NCT01200602|FG001|Participant Flow|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
11365626|NCT01200602|OG000|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
11365627|NCT01200602|OG001|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
11365628|NCT01200602|EG000|Reported Event|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
11365629|NCT01200602|EG001|Reported Event|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
11365630|NCT01198548|BG000|Baseline|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
11365631|NCT01198548|FG000|Participant Flow|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
11365632|NCT01198548|OG000|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
11365633|NCT01198548|EG000|Reported Event|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
11365634|NCT01194908|BG000|Baseline|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
11365635|NCT01194908|FG000|Participant Flow|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
11365636|NCT01194908|OG000|Outcome|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
11365637|NCT01194908|EG000|Reported Event|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
11365638|NCT01194856|BG000|Baseline|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
11365639|NCT01194856|BG001|Baseline|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
11365640|NCT01194856|BG002|Baseline|Total|Total of all reporting groups
11365641|NCT01194856|FG000|Participant Flow|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
11365642|NCT01194856|FG001|Participant Flow|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
11365643|NCT01194856|OG000|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
11365644|NCT01194856|OG001|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
11365645|NCT01194856|EG000|Reported Event|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
11365646|NCT01194856|EG001|Reported Event|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
11365647|NCT01194427|BG000|Baseline|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
11365648|NCT01194427|FG000|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
11365649|NCT01194427|OG000|Outcome|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
11365650|NCT01194427|EG000|Reported Event|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
11365651|NCT01193556|BG000|Baseline|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
11365652|NCT01193556|BG001|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
11365653|NCT01193556|BG002|Baseline|Total|Total of all reporting groups
11365654|NCT01193556|FG000|Participant Flow|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
11365655|NCT01193556|FG001|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
11365656|NCT01193556|OG000|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
11365657|NCT01193556|OG001|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
11365658|NCT01193556|EG000|Reported Event|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
11365659|NCT01193556|EG001|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
11365660|NCT01189435|BG000|Baseline|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
11365661|NCT01189435|FG000|Participant Flow|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
11377077|NCT00972179|BG004|Baseline|Tezepelumab 210 mg Q7D|Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
11365662|NCT01189435|OG000|Outcome|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
11365663|NCT01189435|EG000|Reported Event|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
11365664|NCT01193530|BG000|Baseline|Bright Light Therapy|Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
11365665|NCT01193530|BG001|Baseline|Dim Red Light Therapy|Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
11365666|NCT01193530|BG002|Baseline|Total|Total of all reporting groups
11365667|NCT01193530|FG000|Participant Flow|Bright Light Therapy|Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
11365668|NCT01193530|FG001|Participant Flow|Dim Red Light Therapy|Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
11365669|NCT01193530|OG000|Outcome|Bright Light Therapy|Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
11365670|NCT01193530|OG001|Outcome|Dim Red Light Therapy|Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
11365671|NCT01193530|EG000|Reported Event|Bright Light Therapy|Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
11365672|NCT01193530|EG001|Reported Event|Dim Red Light Therapy|Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
11365673|NCT01182610|BG000|Baseline|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36~Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
11365674|NCT01182610|FG000|Participant Flow|Treatment Group|"Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
11365675|NCT01182610|OG000|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
11365676|NCT01182610|EG000|Reported Event|Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU|Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36
11365677|NCT01189071|BG000|Baseline|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
11365678|NCT01189071|BG001|Baseline|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
11365679|NCT01189071|BG002|Baseline|Total|Total of all reporting groups
11365680|NCT01189071|FG000|Participant Flow|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
11365681|NCT01189071|FG001|Participant Flow|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
11365682|NCT01189071|OG000|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
11365683|NCT01189071|OG001|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
11365684|NCT01189071|EG000|Reported Event|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
11365685|NCT01189071|EG001|Reported Event|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
11377078|NCT00972179|BG005|Baseline|Tezepelumab 700 mg Q28D IV|Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
11365686|NCT01183416|BG000|Baseline|3F8 Monoclonal Antibody and 13-cis-Retinoic Acid|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse.~3F8 monoclonal antibody and 13-cis-Retinoic Acid: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2."
11365687|NCT01183416|FG000|Participant Flow|3F8 Monoclonal Antibody and 13-cis-Retinoic Acid|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse.~3F8 monoclonal antibody and 13-cis-Retinoic Acid: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2."
11365688|NCT01183416|OG000|Outcome|3F8 Monoclonal Antibody and 13-cis-Retinoic Acid|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse.~3F8 monoclonal antibody and 13-cis-Retinoic Acid: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2."
11365689|NCT01183416|EG000|Reported Event|3F8 Monoclonal Antibody and 13-cis-Retinoic Acid|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse.~3F8 monoclonal antibody and 13-cis-Retinoic Acid: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2."
11365690|NCT01184456|BG000|Baseline|GanedenBC30, GBI-30, PTA-6086|GanedenBC30, GBI-30, PTA-6086: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
11365691|NCT01184456|BG001|Baseline|Placebo|Placebo: 1 capsule per day for 90 days.
11365692|NCT01184456|BG002|Baseline|Total|Total of all reporting groups
11365693|NCT01184456|FG000|Participant Flow|GanedenBC30, GBI-30, PTA-6086|GanedenBC30, GBI-30, PTA-6086: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
11365694|NCT01184456|FG001|Participant Flow|Placebo|Placebo: 1 capsule per day for 90 days.
11365695|NCT01184456|OG000|Outcome|GanedenBC30, GBI-30, PTA-6086|GanedenBC30, GBI-30, PTA-6086: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
11365696|NCT01184456|OG001|Outcome|Placebo|Placebo: 1 capsule per day for 90 days.
11365697|NCT01184456|EG000|Reported Event|GanedenBC30, GBI-30, PTA-6086|GanedenBC30, GBI-30, PTA-6086: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
11365698|NCT01184456|EG001|Reported Event|Placebo|Placebo: 1 capsule per day for 90 days.
11365699|NCT01183221|BG000|Baseline|Syntocinon Then Placebo|One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo
11365700|NCT01183221|BG001|Baseline|Placebo Then Syntocinon|Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon
11365701|NCT01183221|BG002|Baseline|Total|Total of all reporting groups
11365702|NCT01183221|FG000|Participant Flow|Syntocinon Then Placebo|One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo
11365703|NCT01183221|FG001|Participant Flow|Placebo Then Syntocinon|Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon
11365704|NCT01183221|OG000|Outcome|Syntocinon Then Placebo|One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo
11365705|NCT01183221|OG001|Outcome|Placebo Then Syntocinon|Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon
11365706|NCT01183221|EG000|Reported Event|Syntocinon|One dose 24IU (3 sprays/nostril) intranasal oxytocin,
11365707|NCT01183221|EG001|Reported Event|Placebo|Intranasal Placebo
11365708|NCT01189227|BG000|Baseline|Postoperative Chemotherapy|Postoperative chemotherapy
11365709|NCT01189227|BG001|Baseline|Perioperative Chemotherapy|Perioperative chemotherapy
11365710|NCT01189227|BG002|Baseline|Total|Total of all reporting groups
11365711|NCT01189227|FG000|Participant Flow|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
11365712|NCT01189227|FG001|Participant Flow|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
11365713|NCT01189227|OG000|Outcome|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
11377079|NCT00972179|BG006|Baseline|Placebo|Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
11365714|NCT01189227|OG001|Outcome|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
11365715|NCT01189227|EG000|Reported Event|Postoperative Chemotherapy|Postoperative chemotherapy
11365716|NCT01189227|EG001|Reported Event|Perioperative Chemotherapy|Perioperative chemotherapy
11365717|NCT01190306|BG000|Baseline|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
11365718|NCT01190306|BG001|Baseline|Sham Control|Eyes in the control group will be treated with riboflavin only.
11365719|NCT01190306|BG002|Baseline|Total|Total of all reporting groups
11365720|NCT01190306|FG000|Participant Flow|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
11365721|NCT01190306|FG001|Participant Flow|Sham Control|Eyes in the control group will be treated with riboflavin only.
11365722|NCT01190306|OG000|Outcome|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
11365723|NCT01190306|OG001|Outcome|Sham Control|Eyes in the control group will be treated with riboflavin only.
11365724|NCT01190306|EG000|Reported Event|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
11365725|NCT01190306|EG001|Reported Event|Sham Control|Eyes in the control group will be treated with riboflavin only.
11365726|NCT01179737|BG000|Baseline|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
11365727|NCT01179737|BG001|Baseline|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
11365728|NCT01179737|BG002|Baseline|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
11365729|NCT01179737|BG003|Baseline|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
11365730|NCT01179737|BG004|Baseline|Total|Total of all reporting groups
11365731|NCT01179737|FG000|Participant Flow|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
11365732|NCT01179737|FG001|Participant Flow|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
11365733|NCT01179737|FG002|Participant Flow|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
11365734|NCT01179737|FG003|Participant Flow|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
11365735|NCT01179737|OG000|Outcome|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minu
11365736|NCT01179737|OG000|Outcome|Change in Pulmonary Vascular Resistance (PVR)|"Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR).~Additional information about the outcome measure, if needed for clarification. Outcome Measures are: Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.~Examples:~Title: all cause mortality Time Frame: one year Safety Issue: No~Title: Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI Time Frame: within the first 30 days (plus or minus 3 days) after surgery Safety Issue: Yes"
11365737|NCT01179737|OG000|Outcome|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section.
11365738|NCT01179737|EG000|Reported Event|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
11365739|NCT01179737|EG001|Reported Event|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
11365740|NCT01179737|EG002|Reported Event|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
11365741|NCT01179737|EG003|Reported Event|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
11365742|NCT01183468|BG000|Baseline|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
11365743|NCT01183468|BG001|Baseline|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
11377080|NCT00972179|BG007|Baseline|Total|Total of all reporting groups
11377081|NCT00972179|FG000|Participant Flow|Tezepelumab 35 mg Q28D|Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
11377082|NCT00972179|FG001|Participant Flow|Tezepelumab 105 mg Q28D|Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
11377083|NCT00972179|FG002|Participant Flow|Tezepelumab 210 mg Q28D|Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
11377084|NCT00972179|FG003|Participant Flow|Tezepelumab 210 mg Q14D|Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
11365744|NCT01183468|BG002|Baseline|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
11365745|NCT01183468|BG003|Baseline|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
11365746|NCT01183468|BG004|Baseline|Total|Total of all reporting groups
11365747|NCT01183468|FG000|Participant Flow|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
11365748|NCT01183468|FG001|Participant Flow|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
11365749|NCT01183468|FG002|Participant Flow|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
11365750|NCT01183468|FG003|Participant Flow|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
11365751|NCT01183468|OG000|Outcome|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
11365752|NCT01183468|OG001|Outcome|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
11365753|NCT01183468|OG002|Outcome|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
11365754|NCT01183468|OG003|Outcome|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
11365755|NCT01183468|EG000|Reported Event|Subjects Aged 16 - 35 Years|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
11365756|NCT01183468|EG001|Reported Event|Subjects Aged 8 - 15 Years|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
11365757|NCT01181921|BG000|Baseline|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
11365758|NCT01181921|FG000|Participant Flow|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
11365759|NCT01181921|OG000|Outcome|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
11365760|NCT01181921|EG000|Reported Event|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
11377085|NCT00972179|FG004|Participant Flow|Tezepelumab 210 mg Q7D|Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
11377086|NCT00972179|FG005|Participant Flow|Tezepelumab 700 mg Q28D IV|Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
11189211|NCT02118792|OG001|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11365761|NCT01188798|BG000|Baseline|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Methotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365762|NCT01188798|BG001|Baseline|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365763|NCT01188798|BG002|Baseline|Total|Total of all reporting groups
11365764|NCT01188798|FG000|Participant Flow|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365765|NCT01188798|FG001|Participant Flow|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365766|NCT01188798|OG000|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365767|NCT01188798|OG001|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365768|NCT01188798|OG001|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin).~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365769|NCT01188798|EG000|Reported Event|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365770|NCT01188798|EG001|Reported Event|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
11365771|NCT01174368|BG000|Baseline|Cancer Macrobeads|"Cancer Macrobead placement in abdominal cavity~Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram"
11365772|NCT01174368|FG000|Participant Flow|Cancer Macrobeads|"Cancer Macrobead placement in abdominal cavity~Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram"
11365773|NCT01174368|OG000|Outcome|Cancer Macrobeads|"Cancer Macrobead placement in abdominal cavity~Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram"
11365774|NCT01174368|EG000|Reported Event|Cancer Macrobeads|"Cancer Macrobead placement in abdominal cavity~Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram"
11365775|NCT01183897|BG000|Baseline|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic|This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
11365776|NCT01183897|FG000|Participant Flow|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic|This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
11365777|NCT01183897|OG000|Outcome|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic|This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
11365778|NCT01183897|EG000|Reported Event|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic|This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
11377087|NCT00972179|FG006|Participant Flow|Placebo|Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
11365779|NCT01183884|BG000|Baseline|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid|This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
11365780|NCT01183884|FG000|Participant Flow|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid|This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
11365781|NCT01183884|OG000|Outcome|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid|This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
11365782|NCT01183884|EG000|Reported Event|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid|This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
11365783|NCT01183429|BG000|Baseline|3F8 and 13-cis-retinoic Acid|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(8), patients no longer receive high dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles.~3F8 and 13-cis-retinoic acid: 3F8 is dosed at 80 mg/m2/day (cycles 1-2) or 20 mg/m2/day (cycles 3 and beyond) and infused iv over 30-90 minutes. 13-cis-retinoic acid is dosed at 160 mg/m2/day, divided into two doses, x14 days. If a dose is missed, it can be made up at the end of the cycle. It is not taken on same days as 3F8. *High-dose 3F8 will be administered only for patients enrolled on protocol from A(0) to A(7). Starting with A(8), patients receive standard dose (20mg/m2/day) during cycles 1 and 2."
11365784|NCT01183429|FG000|Participant Flow|3F8 and 13-cis-retinoic Acid|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(8), patients no longer receive high dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles.~3F8 and 13-cis-retinoic acid: 3F8 is dosed at 80 mg/m2/day (cycles 1-2) or 20 mg/m2/day (cycles 3 and beyond) and infused iv over 30-90 minutes. 13-cis-retinoic acid is dosed at 160 mg/m2/day, divided into two doses, x14 days. If a dose is missed, it can be made up at the end of the cycle. It is not taken on same days as 3F8. *High-dose 3F8 will be administered only for patients enrolled on protocol from A(0) to A(7). Starting with A(8), patients receive standard dose (20mg/m2/day) during cycles 1 and 2."
11365785|NCT01183429|OG000|Outcome|3F8 and 13-cis-retinoic Acid|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(8), patients no longer receive high dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles.~3F8 and 13-cis-retinoic acid: 3F8 is dosed at 80 mg/m2/day (cycles 1-2) or 20 mg/m2/day (cycles 3 and beyond) and infused iv over 30-90 minutes. 13-cis-retinoic acid is dosed at 160 mg/m2/day, divided into two doses, x14 days. If a dose is missed, it can be made up at the end of the cycle. It is not taken on same days as 3F8. *High-dose 3F8 will be administered only for patients enrolled on protocol from A(0) to A(7). Starting with A(8), patients receive standard dose (20mg/m2/day) during cycles 1 and 2."
11365786|NCT01183429|EG000|Reported Event|3F8 and 13-cis-retinoic Acid|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(8), patients no longer receive high dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles.~3F8 and 13-cis-retinoic acid: 3F8 is dosed at 80 mg/m2/day (cycles 1-2) or 20 mg/m2/day (cycles 3 and beyond) and infused iv over 30-90 minutes. 13-cis-retinoic acid is dosed at 160 mg/m2/day, divided into two doses, x14 days. If a dose is missed, it can be made up at the end of the cycle. It is not taken on same days as 3F8. *High-dose 3F8 will be administered only for patients enrolled on protocol from A(0) to A(7). Starting with A(8), patients receive standard dose (20mg/m2/day) during cycles 1 and 2."
11365787|NCT01166178|BG000|Baseline|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
11365788|NCT01166178|BG001|Baseline|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
11365789|NCT01166178|BG002|Baseline|Total|Total of all reporting groups
11189212|NCT02118792|OG000|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11189213|NCT02118792|OG001|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11365790|NCT01166178|FG000|Participant Flow|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
11365791|NCT01166178|FG001|Participant Flow|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
11365792|NCT01166178|OG000|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
11365793|NCT01166178|OG001|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
11365794|NCT01166178|EG000|Reported Event|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
11365795|NCT01166178|EG001|Reported Event|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
11365796|NCT01176513|BG000|Baseline|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
11365797|NCT01176513|FG000|Participant Flow|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
11365798|NCT01176513|OG000|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
11365799|NCT01176513|EG000|Reported Event|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
11365800|NCT01165450|BG000|Baseline|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
11365801|NCT01165450|FG000|Participant Flow|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
11365802|NCT01165450|OG000|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
11365803|NCT01165450|EG000|Reported Event|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
11365804|NCT01179399|BG000|Baseline|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
11365805|NCT01179399|FG000|Participant Flow|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
11189214|NCT02118792|EG000|Reported Event|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11365806|NCT01179399|OG000|Outcome|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
11365807|NCT01179399|EG000|Reported Event|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
11365808|NCT01169753|BG000|Baseline|Placebo|Oral placebo every morning for 2 weeks.
11365809|NCT01169753|BG001|Baseline|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
11365810|NCT01169753|BG002|Baseline|Total|Total of all reporting groups
11365811|NCT01169753|FG000|Participant Flow|Placebo|Oral placebo every morning for 2 weeks.
11365812|NCT01169753|FG001|Participant Flow|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
11365813|NCT01169753|OG000|Outcome|Placebo|Oral placebo every morning for 2 weeks.
11365814|NCT01169753|OG001|Outcome|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
11365815|NCT01169753|EG000|Reported Event|Placebo|Oral placebo every morning for 2 weeks.
11365816|NCT01169753|EG001|Reported Event|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
11365817|NCT01171534|BG000|Baseline|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
11365818|NCT01171534|BG001|Baseline|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
11365819|NCT01171534|BG002|Baseline|Total|Total of all reporting groups
11365820|NCT01171534|FG000|Participant Flow|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
11365821|NCT01171534|FG001|Participant Flow|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
11365822|NCT01171534|OG000|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
11365823|NCT01171534|OG001|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
11365824|NCT01171534|EG000|Reported Event|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
11365825|NCT01171534|EG001|Reported Event|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
11377088|NCT00972179|OG000|Outcome|Tezepelumab 35 mg Q28D|Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
11365826|NCT01169610|BG000|Baseline|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
11365827|NCT01169610|FG000|Participant Flow|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
11365828|NCT01169610|OG000|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
11365829|NCT01169610|EG000|Reported Event|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
11365830|NCT01163084|BG000|Baseline|Group A- GDC-0449 and Androgen Ablation (LHRHa)|Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy.
11365831|NCT01163084|BG001|Baseline|Group- B Androgren Ablation (LHRHa) Alone|Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
11365832|NCT01163084|BG002|Baseline|Total|Total of all reporting groups
11365833|NCT01163084|FG000|Participant Flow|Group A- GDC-0449 and Androgen Ablation (LHRHa)|Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy.
11365834|NCT01163084|FG001|Participant Flow|Group B- Androgren Ablation (LHRHa) Alone|Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
11365835|NCT01163084|OG000|Outcome|Group A-GDC-0449 and Androgen Ablation (LHRHa|Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy
11365836|NCT01163084|OG001|Outcome|Group B Androgen Ablation (LHRHa) Alone|Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
11365837|NCT01163084|EG000|Reported Event|Group A- GDC-0449 and Androgen Ablation (LHRHa)|Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy.
11365838|NCT01163084|EG001|Reported Event|Group B- Androgren Ablation (LHRHa) Alone|Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
11365839|NCT01166724|BG000|Baseline|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
11365840|NCT01166724|BG001|Baseline|Tacrolimus|Patient will stay on Tacrolimus
11365841|NCT01166724|BG002|Baseline|Total|Total of all reporting groups
11365842|NCT01166724|FG000|Participant Flow|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
11365843|NCT01166724|FG001|Participant Flow|Tacrolimus|Patient will stay on Tacrolimus
11365844|NCT01166724|OG000|Outcome|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
11365845|NCT01166724|OG001|Outcome|Tacrolimus|Patient will stay on Tacrolimus
11365846|NCT01166724|EG000|Reported Event|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
11365847|NCT01166724|EG001|Reported Event|Tacrolimus|Patient will stay on Tacrolimus
11365848|NCT01162382|BG000|Baseline|Transcranial Magnetic Stimulation|"Open-label transcranial magnetic stimulation~Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex."
11189215|NCT02118792|EG001|Reported Event|AN2728 Topical Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
11189216|NCT02118831|BG000|Baseline|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
11365849|NCT01162382|FG000|Participant Flow|Transcranial Magnetic Stimulation|"Open-label transcranial magnetic stimulation~Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex."
11365850|NCT01162382|OG000|Outcome|Transcranial Magnetic Stimulation|"Open-label transcranial magnetic stimulation~Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex."
11365851|NCT01162382|EG000|Reported Event|Transcranial Magnetic Stimulation|"Open-label transcranial magnetic stimulation~Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex."
11365852|NCT01157533|BG000|Baseline|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
11365853|NCT01157533|FG000|Participant Flow|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
11365854|NCT01157533|OG000|Outcome|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
11365855|NCT01157533|EG000|Reported Event|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
11365856|NCT01162304|BG000|Baseline|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours~IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
11365857|NCT01162304|FG000|Participant Flow|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours~IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
11365858|NCT01162304|OG000|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
11365859|NCT01162304|OG001|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
11365860|NCT01162304|EG000|Reported Event|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
11365861|NCT01162304|EG001|Reported Event|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
11365862|NCT01151904|BG000|Baseline|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
11365863|NCT01151904|FG000|Participant Flow|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
11365864|NCT01151904|OG000|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
11365865|NCT01151904|EG000|Reported Event|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
11365866|NCT01155518|BG000|Baseline|Testosterone|"intramuscular injections every 2 weeks~testosterone: intramuscular every 2 weeks"
11365867|NCT01155518|BG001|Baseline|Clomiphene|"oral drug thrice a week~clomiphene: thrice a week"
11365868|NCT01155518|BG002|Baseline|Placebo for Testosterone|"placebo for testosterone arm~placebo: intramuscular saline injections every 2 weeks"
11365869|NCT01155518|BG003|Baseline|Placebo for Clomiphene|"oral placebo for clomiphene arm~placebo: oral"
11365870|NCT01155518|BG004|Baseline|Eugonadal Obese|obese men with normal testosterone level
11365871|NCT01155518|BG005|Baseline|Lean|healthy lean men (control)
11240131|NCT02476448|FG003|Participant Flow|Sodium Fluorescein|"Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.~Sodium Fluorescein: Administered intravenously and assessed during cystoscopy"
11240132|NCT02476448|OG000|Outcome|Normal Saline|"Infused into the bladder to allow for visualization of bladder walls and urine jets.~Normal saline: Used to distend the bladder for cystoscopic evaluation"
11240133|NCT02476448|OG001|Outcome|Dextrose 10%|"Infused into the bladder to allow for visualization of bladder walls and colored urine jets.~Dextrose 10%: Used to distend the bladder for cystoscopic evaluation"
11365872|NCT01155518|BG006|Baseline|Total|Total of all reporting groups
11365873|NCT01155518|FG000|Participant Flow|Testosterone|"intramuscular injections every 2 weeks~testosterone: intramuscular every 2 weeks"
11365874|NCT01155518|FG001|Participant Flow|Clomiphene|"oral drug thrice a week~clomiphene: thrice a week"
11365875|NCT01155518|FG002|Participant Flow|Placebo for Testosterone|"placebo for testosterone arm~placebo: intramuscular saline injections every 2 weeks"
11365876|NCT01155518|FG003|Participant Flow|Placebo for Clomiphene|"oral placebo for clomiphene arm~placebo: oral"
11365877|NCT01155518|FG004|Participant Flow|Eugonadal Obese|men with obesity and normal testosterone levels
11365878|NCT01155518|FG005|Participant Flow|Control|lean healthy men with normal testosterone levels
11365879|NCT01155518|OG000|Outcome|Testosterone|"intramuscular injections every 2 weeks~testosterone: intramuscular every 2 weeks"
11365880|NCT01155518|OG001|Outcome|Clomiphene|"oral drug thrice a week~clomiphene: thrice a week"
11365881|NCT01155518|OG002|Outcome|Placebo for Testosterone|"placebo for testosterone arm~placebo: intramuscular saline injections every 2 weeks"
11365882|NCT01155518|OG003|Outcome|Placebo for Clomiphene|"oral placebo for clomiphene arm~placebo: oral"
11365883|NCT01155518|OG004|Outcome|Eugonadal Obese|normal testosterone men
11365884|NCT01155518|OG005|Outcome|Normal Lean|control
11365885|NCT01155518|EG000|Reported Event|Testosterone|"intramuscular injections every 2 weeks~testosterone: intramuscular every 2 weeks"
11365886|NCT01155518|EG001|Reported Event|Clomiphene|"oral drug thrice a week~clomiphene: thrice a week"
11365887|NCT01155518|EG002|Reported Event|Placebo for Testosterone|"placebo for testosterone arm~placebo: intramuscular saline injections every 2 weeks"
11365888|NCT01155518|EG003|Reported Event|Placebo for Clomiphene|"oral placebo for clomiphene arm~placebo: oral"
11365889|NCT01155518|EG004|Reported Event|Eugonadal Obese|obese men with normal testosterone levels
11365890|NCT01155518|EG005|Reported Event|Control|healthy lean men with normal testosterone levels
11365891|NCT01150409|BG000|Baseline|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
11365892|NCT01150409|BG001|Baseline|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
11365893|NCT01150409|BG002|Baseline|Total|Total of all reporting groups
11365894|NCT01150409|FG000|Participant Flow|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
11365895|NCT01150409|FG001|Participant Flow|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
11365896|NCT01150409|OG000|Outcome|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
11365897|NCT01150409|OG001|Outcome|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
11365898|NCT01150409|EG000|Reported Event|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
11365899|NCT01150409|EG001|Reported Event|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
11365900|NCT01151553|BG000|Baseline|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
11365901|NCT01151553|FG000|Participant Flow|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
11365902|NCT01151553|OG000|Outcome|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
11365903|NCT01151553|EG000|Reported Event|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
11240134|NCT02476448|OG002|Outcome|Phenazopyridine|"Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy.~Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy"
11365904|NCT01148056|BG000|Baseline|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
11365905|NCT01148056|FG000|Participant Flow|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
11365906|NCT01148056|OG000|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
11365907|NCT01148056|EG000|Reported Event|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
11365908|NCT01147393|BG000|Baseline|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
11365909|NCT01147393|FG000|Participant Flow|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
11365910|NCT01147393|OG000|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
11365911|NCT01147393|EG000|Reported Event|Dose Level 1|veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 15 mCi/m2
11365912|NCT01147393|EG001|Reported Event|Dose Level -1|veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 10 mCi/m2
11365913|NCT01147042|BG000|Baseline|gp91 CGD With Relatively High Baseline Superoxide|"Subjects in this cohort have X-linked CGD resulting from a documented missense gene and superoxide production by cytochrome c reduction assay at baseline of greater than 2.5 nmol/106 cells per hour.~Following a washout period subjects have a subcutaneous injection of 50 mcg per meter squared administered once per week, Monday, for 4 weeks, twice per week, Monday and Thursday, for 4 weeks, then thrice per week, Monday, Wednesday, Friday, for 4 weeks for a total of 12 weeks of Interferon-gamma treatment."
11365914|NCT01147042|BG001|Baseline|Autosomal Recessive CGD With p47|"Subjects in this cohort have autosomal recessive CGD resulting from a documented p47phox gene mutation.~Subjects will then be started on a 12 week course of IFN treatment. Subjects will have a subcutaneous injection of 50 mcg/m2 once per week (Monday) for 4 weeks, twice per week (Monday and Thursday) for 4 weeks, then thrice per week (Monday, Wednesday, Friday) for 4 weeks."
11365915|NCT01147042|BG002|Baseline|Total|Total of all reporting groups
11365916|NCT01147042|FG000|Participant Flow|gp91 CGD With HIGH Baseline Superoxide|Patients with X-linked Chronic Granulomatous Disease (CGD) with a missense gp91phox mutation and relatively high baseline superoxide production
11365917|NCT01147042|FG001|Participant Flow|Autosomal Recessive CGD With p47|Patients with Autosomal Recessive Chronic Granulomatous Disease (CGD) with p47 phox mutation
11365918|NCT01147042|OG000|Outcome|gp91 CGD With HIGH Baseline Superoxide|Patients with X-linked Chronic Granulomatous Disease (CGD) with a missense gp91phox mutation and relatively high baseline superoxide production
11365919|NCT01147042|OG001|Outcome|Autosomal Recessive CGD With p47|Patients with Autosomal Recessive Chronic Granulomatous Disease (CGD) with p47 phox mutation
11365920|NCT01147042|EG000|Reported Event|gp91 CGD With Relatively High Baseline Superoxide|Patients with X-linked Chronic Granulomatous Disease (CGD) with a missense gp91phox mutation and relatively high baseline superoxide production
11376278|NCT00980460|OG003|Outcome|High-risk Group (Regimen H)|"Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376279|NCT00980460|OG000|Outcome|Intermediate-risk Group (Regimen F)|"Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)~Cisplatin: Given IV~Dexrazoxane: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11377089|NCT00972179|OG001|Outcome|Tezepelumab 105 mg Q28D|Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
11377090|NCT00972179|OG002|Outcome|Tezepelumab 210 mg Q28D|Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
11377091|NCT00972179|OG003|Outcome|Tezepelumab 210 mg Q14D|Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
11377092|NCT00972179|OG004|Outcome|Tezepelumab 210 mg Q7D|Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
11365921|NCT01147536|BG000|Baseline|HSPPC-96 Vaccine|Participants received up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
11365922|NCT01147536|FG000|Participant Flow|HSPPC-96 Vaccine|Participants received up to 8 administrations of HSPPC-96 (heat shock protein peptide complex-96) (Vitespen or Oncophage) 25 micrograms [µg] intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
11365923|NCT01147536|OG000|Outcome|HSPPC-96 Vaccine|Participants received up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
11365924|NCT01147536|EG000|Reported Event|HSPPC-96 Vaccine|Participants received up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
11365925|NCT01139996|BG000|Baseline|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
11365926|NCT01139996|BG001|Baseline|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
11365927|NCT01139996|BG002|Baseline|Total|Total of all reporting groups
11365928|NCT01139996|FG000|Participant Flow|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
11365929|NCT01139996|FG001|Participant Flow|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
11365930|NCT01139996|OG000|Outcome|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
11365931|NCT01139996|OG001|Outcome|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
11365932|NCT01139996|EG000|Reported Event|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
11365933|NCT01139996|EG001|Reported Event|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
11365934|NCT01133288|BG000|Baseline|Yulex Glove|Yulex Glove Treatment
11365935|NCT01133288|FG000|Participant Flow|Yulex Glove|Yulex Glove Treatment
11365936|NCT01133288|OG000|Outcome|Yulex Glove|Yulex Glove Treatment
11365937|NCT01133288|EG000|Reported Event|Yulex Glove|Yulex Glove Treatment
11365938|NCT01142128|BG000|Baseline|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
11365939|NCT01142128|BG001|Baseline|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
11365940|NCT01142128|BG002|Baseline|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
11365941|NCT01142128|BG003|Baseline|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
11365942|NCT01142128|BG004|Baseline|Total|Total of all reporting groups
11365943|NCT01142128|FG000|Participant Flow|All Participants|"Participants received one of four interventions in a randomized crossover design:~Nexium Alone: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium~Placebo to Nexium, Alone: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium~Viokase 16 Plus Nexium: Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium~Viokase 16 Plus Placebo to Nexium: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone"
11365944|NCT01142128|OG000|Outcome|Nexium Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
11365945|NCT01142128|OG000|Outcome|Placebo to Nexium, Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
11365946|NCT01142128|OG000|Outcome|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
11365947|NCT01142128|OG000|Outcome|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
11365948|NCT01142128|EG000|Reported Event|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
11365949|NCT01142128|EG001|Reported Event|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
11365950|NCT01142128|EG002|Reported Event|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
11365951|NCT01142128|EG003|Reported Event|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
11365952|NCT01131884|BG000|Baseline|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
11365953|NCT01131884|BG001|Baseline|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
11365954|NCT01131884|BG002|Baseline|Total|Total of all reporting groups
11365955|NCT01131884|FG000|Participant Flow|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
11365956|NCT01131884|FG001|Participant Flow|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
11365957|NCT01131884|OG000|Outcome|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
11365958|NCT01131884|OG001|Outcome|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
11365959|NCT01131884|EG000|Reported Event|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
11365960|NCT01131884|EG001|Reported Event|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
11365961|NCT01128114|BG000|Baseline|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
11365962|NCT01128114|FG000|Participant Flow|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
11365963|NCT01128114|OG000|Outcome|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
11365964|NCT01128114|EG000|Reported Event|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
11365965|NCT01126879|BG000|Baseline|Arm I - Genistein|"Patients receive oral genistein or placebo once daily for 3 months beginning at least 2 weeks prior to radical prostatectomy.~Genistein: Given orally~Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer"
11365966|NCT01126879|BG001|Baseline|Arm II - Placebo|"Patients receive oral genistein or placebo once daily for 3 months beginning at least 2 weeks prior to radical prostatectomy.~Placebo: Given orally~Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer"
11365967|NCT01126879|BG002|Baseline|Total|Total of all reporting groups
11365968|NCT01126879|FG000|Participant Flow|Arm I - Genistein|"Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.~Genistein: Given orally~Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer"
11365969|NCT01126879|FG001|Participant Flow|Arm II - Placebo|"Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.~Placebo: Given orally~Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer"
11189217|NCT02118831|BG001|Baseline|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
11365970|NCT01126879|OG000|Outcome|Arm I - Genistein|"Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.~Genistein: Given orally~Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer"
11365971|NCT01126879|OG001|Outcome|Arm II - Placebo|"Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.~Placebo: Given orally~Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer"
11365972|NCT01126879|EG000|Reported Event|Arm I - Genistein|"Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.~Genistein: Given orally~Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer"
11365973|NCT01126879|EG001|Reported Event|Arm II - Placebo|"Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.~Placebo: Given orally~Therapeutic conventional surgery: Radical prostatectomy for treatment of prostate cancer"
11365974|NCT01136811|BG000|Baseline|Computer Assisted Surgery|"Computer assisted surgery: use of computer assisted surgical device in vascular surgery~completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure"
11365975|NCT01136811|FG000|Participant Flow|Computer Assisted Surgery|"Computer assisted surgery: use of computer assisted surgical device in vascular surgery~completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure"
11365976|NCT01136811|OG000|Outcome|Computer Assisted Surgery|"Computer assisted surgery: use of computer assisted surgical device in vascular surgery~completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure"
11365977|NCT01136811|EG000|Reported Event|Computer Assisted Surgery|"Computer assisted surgery: use of computer assisted surgical device in vascular surgery~completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure"
11365978|NCT01139294|BG000|Baseline|Standard of Care IV Therapy|control arm of the study
11365979|NCT01139294|BG001|Baseline|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
11365980|NCT01139294|BG002|Baseline|Total|Total of all reporting groups
11365981|NCT01139294|FG000|Participant Flow|Standard of Care IV Therapy|control arm of the study
11365982|NCT01139294|FG001|Participant Flow|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
11365983|NCT01139294|OG000|Outcome|Standard of Care IV Therapy|control arm of the study
11365984|NCT01139294|OG001|Outcome|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
11365985|NCT01139294|EG000|Reported Event|Standard of Care IV Therapy|control arm of the study
11365986|NCT01139294|EG001|Reported Event|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
11365987|NCT01139125|BG000|Baseline|Cystagon|One black male and two white males started the study
11365988|NCT01139125|FG000|Participant Flow|Cystagon (Cysteamine Bitartrate)|Subjects were expected to take cystagon (cysteamine bitarate)14 capsules per day (4 at 7:00 am, 3 at 12:00 pm, 4 at 5:00 pm and 3 at 10:00pm) for 16 weeks.
11365989|NCT01139125|OG000|Outcome|Cystagon|Subjects are required to take 14 capsules per day for 16 weeks
11365990|NCT01139125|EG000|Reported Event|Cystagon|Subjects taking 14 capsules per day for 16 weeks
11365991|NCT01136668|BG000|Baseline|Treatment Group|Transversus Abdominis Plane Block: A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
11365992|NCT01136668|BG001|Baseline|Control Group|Standard: Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.
11365993|NCT01136668|BG002|Baseline|Total|Total of all reporting groups
11365994|NCT01136668|FG000|Participant Flow|Treatment Group|Transversus Abdominis Plane Block: A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
11365995|NCT01136668|FG001|Participant Flow|Control Group|Standard: Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.
11365996|NCT01136668|OG000|Outcome|Treatment Group|Transversus Abdominis Plane Block: A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
10963948|NCT00875056|BG002|Baseline|Other Disease|Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
11365997|NCT01136668|OG001|Outcome|Control Group|Standard: Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.
11365998|NCT01136668|EG000|Reported Event|Treatment Group|"Bupivacine-TAP block~Transversus Abdominis Plane Block: A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml."
11365999|NCT01136668|EG001|Reported Event|Control Group|"Bupivacaine- wound infiltration~Standard: Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure."
11366000|NCT01133639|BG000|Baseline|Placebo|"Placebo plus standard of care~Placebo: Placebo plus standard of care"
11366001|NCT01133639|BG001|Baseline|Ketorolac|"30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care~Ketorolac: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care"
11366002|NCT01133639|BG002|Baseline|Total|Total of all reporting groups
11366003|NCT01133639|FG000|Participant Flow|Placebo|"Placebo plus standard of care~Placebo: Placebo plus standard of care"
11366004|NCT01133639|FG001|Participant Flow|Ketorolac|"30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care~Ketorolac: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care"
11366005|NCT01133639|OG000|Outcome|Placebo|"Placebo plus standard of care~Placebo: Placebo plus standard of care"
11366006|NCT01133639|OG001|Outcome|Ketorolac|"30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care~Ketorolac: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care"
11366007|NCT01133639|EG000|Reported Event|Placebo or Ketorolac|"Placebo: Placebo plus standard of care~or~Ketorolac 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care~Ketorolac: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care"
11366008|NCT01131455|BG000|Baseline|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
11366009|NCT01131455|BG001|Baseline|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
11366010|NCT01131455|BG002|Baseline|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
11366011|NCT01131455|BG003|Baseline|Total|Total of all reporting groups
11366012|NCT01131455|FG000|Participant Flow|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
11366013|NCT01131455|FG001|Participant Flow|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
11366014|NCT01131455|FG002|Participant Flow|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
11377093|NCT00972179|OG005|Outcome|Tezepelumab 700 mg Q28D IV|Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
11377094|NCT00972179|OG006|Outcome|Placebo|Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
11377095|NCT00972179|OG000|Outcome|Tezepelumab 35 mg Q28D|Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
10963949|NCT00875056|BG003|Baseline|Total|Total of all reporting groups
11366015|NCT01131455|OG000|Outcome|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
11366016|NCT01131455|OG001|Outcome|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
11366017|NCT01131455|OG002|Outcome|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
11366018|NCT01131455|EG000|Reported Event|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
11366019|NCT01131455|EG001|Reported Event|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
11366020|NCT01131455|EG002|Reported Event|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
11240135|NCT02476448|OG003|Outcome|Sodium Fluorescein|"Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.~Sodium Fluorescein: Administered intravenously and assessed during cystoscopy"
11366021|NCT01126801|BG000|Baseline|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
11366022|NCT01126801|BG001|Baseline|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
11366023|NCT01126801|BG002|Baseline|Total|Total of all reporting groups
11366024|NCT01126801|FG000|Participant Flow|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
11366025|NCT01126801|FG001|Participant Flow|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
11366026|NCT01126801|OG000|Outcome|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
11366027|NCT01126801|OG001|Outcome|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
11366028|NCT01126801|EG000|Reported Event|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
11366029|NCT01126801|EG001|Reported Event|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
11377096|NCT00972179|OG001|Outcome|Tezepelumab 105 mg Q28D|Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
11377097|NCT00972179|OG002|Outcome|Tezepelumab 210 mg Q28D|Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
10963950|NCT00875056|FG000|Participant Flow|Follicular Lymphoma (FL)|Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
11240136|NCT02476448|EG000|Reported Event|Normal Saline|"Infused into the bladder to allow for visualization of bladder walls and urine jets.~Normal saline: Used to distend the bladder for cystoscopic evaluation"
11240137|NCT02476448|EG001|Reported Event|Dextrose 10%|"Infused into the bladder to allow for visualization of bladder walls and colored urine jets.~Dextrose 10%: Used to distend the bladder for cystoscopic evaluation"
11366030|NCT01123850|BG000|Baseline|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
11366031|NCT01123850|FG000|Participant Flow|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
11366032|NCT01123850|OG000|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
11366033|NCT01123850|EG000|Reported Event|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
11366034|NCT01126957|BG000|Baseline|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
11366035|NCT01126957|FG000|Participant Flow|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine or placebo infusion, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
11366036|NCT01126957|OG000|Outcome|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
11366037|NCT01126957|OG000|Outcome|Ketamine|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
11366038|NCT01126957|EG000|Reported Event|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or palcebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
11366039|NCT01127503|BG000|Baseline|Metyrosine|Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
11366040|NCT01127503|BG001|Baseline|Placebo|Placebo: Placebo capsules were identically matched to Metyrosine.
11366041|NCT01127503|BG002|Baseline|Total|Total of all reporting groups
11366042|NCT01127503|FG000|Participant Flow|Metyrosine|Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
11366043|NCT01127503|FG001|Participant Flow|Placebo|Placebo: Placebo capsules were identically matched to Metyrosine.
11366044|NCT01127503|OG000|Outcome|Metyrosine|Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
11366045|NCT01127503|OG001|Outcome|Placebo|Placebo: Placebo capsules were identically matched to Metyrosine.
10963951|NCT00875056|FG001|Participant Flow|Indolent Non-FL B-NHL or MCL|Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
11189218|NCT02118831|BG002|Baseline|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
11366046|NCT01127503|EG000|Reported Event|Metyrosine|Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
11366047|NCT01127503|EG001|Reported Event|Placebo|Placebo: Placebo capsules were identically matched to Metyrosine.
11366048|NCT01122511|BG000|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
11366049|NCT01122511|BG001|Baseline|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
11366050|NCT01122511|BG002|Baseline|Total|Total of all reporting groups
11366051|NCT01122511|FG000|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
11366052|NCT01122511|FG001|Participant Flow|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
11366053|NCT01122511|OG000|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
11366054|NCT01122511|OG001|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
11366055|NCT01122511|EG000|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
11240138|NCT02476448|EG002|Reported Event|Phenazopyridine|"Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy.~Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy"
11366056|NCT01122511|EG001|Reported Event|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
11366057|NCT01118013|BG000|Baseline|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
11366058|NCT01118013|FG000|Participant Flow|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
11366059|NCT01118013|OG000|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
11366060|NCT01118013|EG000|Reported Event|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
11366061|NCT01122381|BG000|Baseline|Arm 1|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
11366062|NCT01122381|BG001|Baseline|Arm 2|"placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability~placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
11366063|NCT01122381|BG002|Baseline|Total|Total of all reporting groups
11366064|NCT01122381|FG000|Participant Flow|Arm 1-drug Treatment|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
11366065|NCT01122381|FG001|Participant Flow|Arm 2-placebo|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
11189219|NCT02118831|BG003|Baseline|Total|Total of all reporting groups
11189220|NCT02118831|FG000|Participant Flow|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
11189221|NCT02118831|FG001|Participant Flow|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
11366066|NCT01122381|OG000|Outcome|Arm 1-ethosuximide|Study was terminated early-no outcome data available. Only one subject was assigned to study drug arm but did not actually take it according to subsequent review of ESX drug levels.
11366067|NCT01122381|OG001|Outcome|Arm 2-placebo Comparator|Study was terminated early-no outcome data available. Only one subject was assigned to study placebo but was dis-enrolled after titration phase due to study termination.
11366068|NCT01122381|EG000|Reported Event|Arm 1- Ethosuximide|ethosuximide blinded capsules of 250mg ESX; subject was titrated up to 4 capsules qd
11366069|NCT01122381|EG001|Reported Event|Arm 2- Placebo Comparator|"placebo blinded capsules of 250mg; subject was titrated up to 4 capsules qd"
11366070|NCT01116232|BG000|Baseline|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
11366071|NCT01116232|FG000|Participant Flow|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
11366072|NCT01116232|OG000|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
11366073|NCT01116232|OG000|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter~Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour~Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose.~."
11366074|NCT01116232|OG000|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter.~rituximab: The total dose chosen"
11366075|NCT01116232|OG000|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter~Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour~Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose."
11366076|NCT01116232|EG000|Reported Event|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
11366077|NCT01110174|BG000|Baseline|HD PET/CT|"utilization of PET/CT for diagnostic of breast cancer progression.~HD PET/CT: imaging"
11366078|NCT01110174|FG000|Participant Flow|HD PET/CT|"utilization of PET/CT for diagnostic of breast cancer progression.~HD PET/CT: imaging"
11366079|NCT01110174|OG000|Outcome|HD PET/CT|"utilization of PET/CT for diagnostic of breast cancer progression.~HD PET/CT: imaging"
11366080|NCT01110174|EG000|Reported Event|HD PET/CT|"utilization of PET/CT for diagnostic of breast cancer progression.~HD PET/CT: imaging"
11366081|NCT01115699|BG000|Baseline|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
11366082|NCT01115699|FG000|Participant Flow|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
11366083|NCT01115699|OG000|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
11366084|NCT01115699|EG000|Reported Event|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
11366085|NCT01108666|BG000|Baseline|Proton RT and Nelfinavir|Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
11366086|NCT01108666|FG000|Participant Flow|Proton RT and Nelfinavir|Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
11366087|NCT01108666|OG000|Outcome|Proton RT and Nelfinavir|Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
11366088|NCT01108666|EG000|Reported Event|Proton RT and Nelfinavir|Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
11366089|NCT01115244|BG000|Baseline|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
11366090|NCT01115244|BG001|Baseline|Not Treated|One arm of the patient will be left untreated.
11366091|NCT01115244|BG002|Baseline|Total|Total of all reporting groups
11366092|NCT01115244|FG000|Participant Flow|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
11366093|NCT01115244|FG001|Participant Flow|Not Treated|One arm of the patient will be left untreated.
11366094|NCT01115244|OG000|Outcome|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
11366095|NCT01115244|OG001|Outcome|Not Treated|One arm of the patient will be left untreated.
11366096|NCT01115244|EG000|Reported Event|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
11366097|NCT01115244|EG001|Reported Event|Not Treated|One arm of the patient will be left untreated.
11366098|NCT01108523|BG000|Baseline|HP828-101|HP828-101 Experimental Formulation
11366099|NCT01108523|FG000|Participant Flow|HP828-101|HP828-101 Experimental Formulation
11366100|NCT01108523|OG000|Outcome|HP828-101|HP828-101 Experimental Formulation
11366101|NCT01108523|EG000|Reported Event|HP828-101|HP828-101 Experimental Formulation
11366102|NCT01107795|BG000|Baseline|Transoral BOT|Participants who received transoral base of tongue surgery as treatment for OASHS.
11366103|NCT01107795|FG000|Participant Flow|Transoral BOT|Participants who received transoral base of tongue surgery as treatment for OASHS.
11366104|NCT01107795|OG000|Outcome|Transoral BOT|Participants who received transoral base of tongue surgery as treatment for OASHS.
11366105|NCT01107795|EG000|Reported Event|Transoral BOT|Participants who received transoral base of tongue surgery as treatment for OASHS.
11366106|NCT01106534|BG000|Baseline|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
11377098|NCT00972179|EG000|Reported Event|Tezepelumab 35 mg Q28D|Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
11377099|NCT00972179|EG001|Reported Event|Tezepelumab 105 mg Q28D|Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
11366107|NCT01106534|FG000|Participant Flow|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
11366108|NCT01106534|OG000|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
11366109|NCT01106534|OG001|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
11366110|NCT01106534|EG000|Reported Event|Second Enrollment Phase of XIENCE V® USA|The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
11366111|NCT01104116|BG000|Baseline|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
11366112|NCT01104116|FG000|Participant Flow|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
11366113|NCT01104116|OG000|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
11366114|NCT01104116|EG000|Reported Event|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
11366115|NCT01100658|BG000|Baseline|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
11366116|NCT01100658|FG000|Participant Flow|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
11366117|NCT01100658|OG000|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
11366118|NCT01100658|EG000|Reported Event|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
11366119|NCT01103180|BG000|Baseline|Escitalopram|10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
11366120|NCT01103180|BG001|Baseline|Placebo|Inert placebo (sugar pill) taken daily for eight weeks
11366121|NCT01103180|BG002|Baseline|Total|Total of all reporting groups
11366122|NCT01103180|FG000|Participant Flow|Escitalopram|10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
11366123|NCT01103180|FG001|Participant Flow|Placebo|Inert placebo (sugar pill) taken daily for eight weeks
11366124|NCT01103180|OG000|Outcome|Escitalopram|"10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)~Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"
11366125|NCT01103180|OG001|Outcome|Placebo|"Inert placebo (sugar pill) taken daily for eight weeks~Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"
11366126|NCT01103180|EG000|Reported Event|Escitalopram|"10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)~Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"
10962734|NCT00868231|FG004|Participant Flow|Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
10962735|NCT00868231|FG005|Participant Flow|Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days."
11366127|NCT01103180|EG001|Reported Event|Placebo|"Inert placebo (sugar pill) taken daily for eight weeks~Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"
11366128|NCT01090141|BG000|Baseline|Subjects Recieving 100 mg of Micafungin|Micafungin: 100 mg IV infusion over 1 hour
11366129|NCT01090141|BG001|Baseline|Subjects Recieving 300 mg of Micafungin|Micafungin: 300 mg IV infusion over 1 hour
11366130|NCT01090141|BG002|Baseline|Total|Total of all reporting groups
11366131|NCT01090141|FG000|Participant Flow|Subjects Recieving 100 mg of Micafungin|Micafungin: 100 mg IV infusion over 1 hour
11366132|NCT01090141|FG001|Participant Flow|Subjects Recieving 300 mg of Micafungin|Micafungin: 300 mg IV infusion over 1 hour
11366133|NCT01090141|OG000|Outcome|Subjects Recieving 100 mg of Micafungin|Micafungin: 100 mg IV infusion over 1 hour
11366134|NCT01090141|OG001|Outcome|Subjects Recieving 300 mg of Micafungin|Micafungin: 300 mg IV infusion over 1 hour
11366135|NCT01090141|EG000|Reported Event|Subjects Recieving 100 mg of Micafungin|Micafungin: 100 mg IV infusion over 1 hour
11366136|NCT01090141|EG001|Reported Event|Subjects Recieving 300 mg of Micafungin|Micafungin: 300 mg IV infusion over 1 hour
11366137|NCT01102140|BG000|Baseline|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
11366138|NCT01102140|BG001|Baseline|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
11366139|NCT01102140|BG002|Baseline|Total|Total of all reporting groups
11366140|NCT01102140|FG000|Participant Flow|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
11366141|NCT01102140|FG001|Participant Flow|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
11366142|NCT01102140|OG000|Outcome|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
11366143|NCT01102140|OG001|Outcome|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
11366144|NCT01102140|OG000|Outcome|POMx|"The POMx subjects will receive 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
11366145|NCT01102140|OG001|Outcome|Control- Sugar Pill|The control subjects received a matching sugar pill for 12 weeks. Sugar Pill: Matching sugar pill
11366146|NCT01102140|EG000|Reported Event|POMx|"15 subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
11366147|NCT01102140|EG001|Reported Event|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
11366148|NCT01095250|BG000|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
11366149|NCT01095250|BG001|Baseline|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
11366150|NCT01095250|BG002|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
11366151|NCT01095250|BG003|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
11366152|NCT01095250|BG004|Baseline|Total|Total of all reporting groups
11366153|NCT01095250|FG000|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
11366154|NCT01095250|FG001|Participant Flow|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
11366155|NCT01095250|FG002|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg subcutaneously at baseline and Week 2, then every 4 weeks.
11366156|NCT01095250|FG003|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
11366157|NCT01095250|OG000|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
11366158|NCT01095250|OG001|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
11366159|NCT01095250|OG002|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
11366160|NCT01095250|OG003|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
11366161|NCT01095250|EG000|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks
11366162|NCT01095250|EG001|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
11366163|NCT01095250|EG002|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
11366164|NCT01095250|EG003|Reported Event|Placebo Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
11366165|NCT01094561|BG000|Baseline|Synthetic Human Secretin|"Single arm (open label).~Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
11366166|NCT01094561|FG000|Participant Flow|Synthetic Human Secretin|"Single arm (open label).~Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
11366167|NCT01094561|OG000|Outcome|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
11366168|NCT01094561|EG000|Reported Event|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
11366169|NCT01093846|BG000|Baseline|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
11366170|NCT01093846|BG001|Baseline|AIN457 300 mg Monthly|300 mg monthly
11366171|NCT01093846|BG002|Baseline|AIN457 Placebo|
11366172|NCT01093846|BG003|Baseline|Total|Total of all reporting groups
11366173|NCT01093846|FG000|Participant Flow|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
11366174|NCT01093846|FG001|Participant Flow|AIN457 300 mg Monthly|300 mg monthly
11366175|NCT01093846|FG002|Participant Flow|AIN457 Placebo|
11366176|NCT01093846|OG000|Outcome|Early Termination|
11366177|NCT01093846|EG000|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period.
11366178|NCT01093846|EG001|Reported Event|AIN457 300mg Monthly|AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period.
11366179|NCT01093846|EG002|Reported Event|Placebo|Placebo Safety is provided over the entire treatment period. This includes the core and extension period.
11366180|NCT01078844|BG000|Baseline|All Participants|"Treatment as usual plus memantine~memantine: memantine 5-20 mg daily~OR~Treatment as usual plus Placebo"
11366181|NCT01078844|FG000|Participant Flow|All Participants|"Treatment as usual plus memantine~memantine: memantine 5-20 mg daily~OR~Treatment as usual plus Placebo"
11366182|NCT01078844|OG000|Outcome|Placebo|"Treatment as usual plus placebo~Placebo: Look-alike placebo"
11366183|NCT01078844|OG001|Outcome|Memantine|"Treatment as usual plus memantine~memantine: memantine 5-20 mg daily"
11366184|NCT01078844|EG000|Reported Event|All Participants|"Treatment as usual plus memantine~memantine: memantine 5-20 mg daily~OR~Treatment as usual plus Placebo"
10962736|NCT00868231|OG000|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
11366185|NCT01081886|BG000|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
11366186|NCT01081886|BG001|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11366187|NCT01081886|BG002|Baseline|Total|Total of all reporting groups
11366188|NCT01081886|FG000|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
11366189|NCT01081886|FG001|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11366190|NCT01081886|OG000|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
11366191|NCT01081886|OG001|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11366192|NCT01081886|EG000|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
11366193|NCT01081886|EG001|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11366194|NCT01085643|BG000|Baseline|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
11366195|NCT01085643|FG000|Participant Flow|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
11366196|NCT01085643|OG000|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
11366197|NCT01085643|EG000|Reported Event|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
11366198|NCT01083472|BG000|Baseline|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
11366199|NCT01083472|BG001|Baseline|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
11366200|NCT01083472|BG002|Baseline|Total|Total of all reporting groups
11366201|NCT01083472|FG000|Participant Flow|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
11366202|NCT01083472|FG001|Participant Flow|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
11366203|NCT01083472|OG000|Outcome|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
11366204|NCT01083472|OG001|Outcome|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
11366205|NCT01083472|EG000|Reported Event|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
11366206|NCT01083472|EG001|Reported Event|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
11377100|NCT00972179|EG002|Reported Event|Tezepelumab 210 mg Q28D|Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
11377101|NCT00972179|EG003|Reported Event|Tezepelumab 210 mg Q14D|Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
11366207|NCT01080768|BG000|Baseline|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
11366208|NCT01080768|BG001|Baseline|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
11366209|NCT01080768|BG002|Baseline|Total|Total of all reporting groups
11366210|NCT01080768|FG000|Participant Flow|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
11366211|NCT01080768|FG001|Participant Flow|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
11366212|NCT01080768|OG000|Outcome|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
11366213|NCT01080768|OG001|Outcome|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
11366214|NCT01080768|EG000|Reported Event|Aliskiren/Amlodipine and Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
11366215|NCT01080768|EG001|Reported Event|Amlodipine and Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
11366216|NCT01079598|BG000|Baseline|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
11366217|NCT01079598|FG000|Participant Flow|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
11366218|NCT01079598|OG000|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
11366219|NCT01079598|EG000|Reported Event|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
11366220|NCT01074502|BG000|Baseline|Apremilast|apremilast 20 mgs twice a day for 12 weeks
11366221|NCT01074502|FG000|Participant Flow|Apremilast|apremilast 20 mgs twice a day for 12 weeks
11366222|NCT01074502|OG000|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
11366223|NCT01074502|EG000|Reported Event|Apremilast|apremilast 20 mgs twice a day for 12 weeks
11366224|NCT01074437|BG000|Baseline|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
11366225|NCT01074437|BG001|Baseline|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
10962737|NCT00868231|OG001|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
11366226|NCT01074437|BG002|Baseline|Total|Total of all reporting groups
11366227|NCT01074437|FG000|Participant Flow|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
11377102|NCT00972179|EG004|Reported Event|Tezepelumab 210 mg Q7D|Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
11366228|NCT01074437|FG001|Participant Flow|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
11366229|NCT01074437|OG000|Outcome|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
11366230|NCT01074437|OG001|Outcome|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
11366231|NCT01074437|EG000|Reported Event|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
11366232|NCT01074437|EG001|Reported Event|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
11366233|NCT01069861|BG000|Baseline|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
11366234|NCT01069861|FG000|Participant Flow|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 milligram per kilogram (mg/kg) over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg per hour (mg/kg/hr) intravenous infusion up to 14 days, based on the need of individual participant.
11366235|NCT01069861|OG000|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
11366236|NCT01069861|EG000|Reported Event|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
11366237|NCT01072526|BG000|Baseline|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
11366238|NCT01072526|FG000|Participant Flow|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
11366239|NCT01072526|FG001|Participant Flow|Control|Cyclosporin (Restasis)ophthalmic solution; 1 drop both eyes twice daily plus placebo solution. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
11366240|NCT01072526|OG000|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
11366241|NCT01072526|OG001|Outcome|Control|cyclosporin ophthalmic solution plus placebo solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
11366242|NCT01072526|OG001|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
11366243|NCT01072526|OG000|Outcome|Intervention|"Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin (Restasis) solution.~Euphrasia-based homeopathic therapy: ophthalmic solution; 1 drop both eyes twice daily~Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
11366244|NCT01072526|OG001|Outcome|Control|"Subjects will receive placebo in combination with cyclosporin (Restasis) solution.~Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
11366245|NCT01072526|EG000|Reported Event|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
11366246|NCT01071993|BG000|Baseline|Atorvastatin|atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
10962738|NCT00868231|OG002|Outcome|Placebo|Placebo via inhalation
11366247|NCT01071993|BG001|Baseline|Placebo|placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
11366248|NCT01071993|BG002|Baseline|Total|Total of all reporting groups
11366249|NCT01071993|FG000|Participant Flow|Atorvastatin|atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
11366250|NCT01071993|FG001|Participant Flow|Placebo|placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
11366251|NCT01071993|OG000|Outcome|Atorvastatin|atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
11366252|NCT01071993|OG001|Outcome|Placebo|placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
11366253|NCT01071993|EG000|Reported Event|Atorvastatin|atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
11366254|NCT01071993|EG001|Reported Event|Placebo|placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
11366255|NCT01065051|BG000|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
11366256|NCT01065051|BG001|Baseline|Placebo|Participants received a single oral dose of 1 mg placebo.
11366257|NCT01065051|BG002|Baseline|Total|Total of all reporting groups
11366258|NCT01065051|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
11366259|NCT01065051|FG001|Participant Flow|Placebo|Participants received a single oral dose of 1 mg placebo.
11366260|NCT01065051|OG000|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
11366261|NCT01065051|OG001|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
11366262|NCT01065051|EG000|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
11366263|NCT01065051|EG001|Reported Event|Placebo|Participants received a single oral dose of 1 mg placebo.
11366264|NCT01069120|BG000|Baseline|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
11366265|NCT01069120|BG001|Baseline|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
11366266|NCT01069120|BG002|Baseline|Total|Total of all reporting groups
11366267|NCT01069120|FG000|Participant Flow|Proellex®|25 or 50 mg capsules once per day
11366268|NCT01069120|OG000|Outcome|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
11366269|NCT01069120|OG001|Outcome|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
11366270|NCT01069120|EG000|Reported Event|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
11366271|NCT01069120|EG001|Reported Event|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
11366272|NCT01066637|BG000|Baseline|Dosimetry Group-measuring Radioisotope in Blood|"To determine its potential for use in humans, we measured the level of 18F-NOS radiopharmaceutical in patients after orthotopic heart transplantation (OHT) (3 women and 9 men) and normal healthy volunteers (2 women and 2 men), and correlated it with pathologic allograft rejection, tissue iNOS levels, and calculated human radiation dosimetry.~The level of 18-F-NOS was measured at different time points in minutes after injection of the radioisotope: The measurement time points were 0/120 minutes, 30/150 minutes, 60/180 minutes, and 90/210 minutes. The imaging began from mid thigh, to the base of the brain."
11366273|NCT01066637|BG001|Baseline|Kinetic Analysis Group-measuring Levels of Nitric Oxide|Measurement of myocardial levels of enzyme nitric oxide synthase(iNOS) using PET and 18F-NOS in post heart transplant patients (5 women and 5 men) undergoing endomyocardial biopsy as part of their normal post-transplant evaluation. Kinetic data of the tracer will be compared with the heart tissue measurements of iNOS measured by immunohistochemistry.
11366274|NCT01066637|BG002|Baseline|Total|Total of all reporting groups
11366275|NCT01066637|FG000|Participant Flow|Dosimetry Group|"To determine its potential for use in humans, we measured 18F-NOS myocardial activity in patients after orthotopic heart transplantation (OHT) (9 women and 9 men) and normal healthy volunteers (2 women and 2 men), and correlated it with pathologic allograft rejection, tissue iNOS levels, and calculated human radiation dosimetry.~[18F](+/-)NOS: Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis"
11366276|NCT01066637|FG001|Participant Flow|Kinetic Analysis Group|"Measurement of myocardial levels of enzyme nitric oxide synthase(iNOS) using PET and 18F-NOS in post heart transplant patients (5 women and 5 men) undergoing endomyocardial biopsy as part of their normal post-transplant evaluation. Kinetic data of the tracer will be compared with the heart tissue measurements of iNOS measured by immunohistochemistry.~[18F](+/-)NOS: Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis"
11366277|NCT01066637|OG000|Outcome|Dosimetry Group|"To determine its potential for use in humans, we measured 18F-NOS myocardial activity in patients after orthotopic heart transplantation (OHT) (9 women and 9 men) and normal healthy volunteers (2 women and 2 men), and correlated it with pathologic allograft rejection, tissue iNOS levels, and calculated human radiation dosimetry.~[18F](+/-)NOS: Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis"
10962739|NCT00868231|EG000|Reported Event|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
11366278|NCT01066637|OG001|Outcome|Kinetic Analysis Group|"Measurement of myocardial levels of enzyme nitric oxide synthase(iNOS) using PET and 18F-NOS in post heart transplant patients (5 women and 5 men) undergoing endomyocardial biopsy as part of their normal post-transplant evaluation. Kinetic data of the tracer will be compared with the heart tissue measurements of iNOS measured by immunohistochemistry.~[18F](+/-)NOS: Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis"
11366279|NCT01066637|EG000|Reported Event|Dosimetry Group|"To determine its potential for use in humans, we measured 18F-NOS myocardial activity in patients after orthotopic heart transplantation (OHT) (9 women and 9 men) and normal healthy volunteers (2 women and 2 men), and correlated it with pathologic allograft rejection, tissue iNOS levels, and calculated human radiation dosimetry.~[18F](+/-)NOS: Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis"
11377103|NCT00972179|EG005|Reported Event|Tezepelumab 700 mg Q28D IV|Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
11377104|NCT00972179|EG006|Reported Event|Tezepelumab Total|All participants who received tezepelumab.
11366280|NCT01066637|EG001|Reported Event|Kinetic Analysis Group|"Measurement of myocardial levels of enzyme nitric oxide synthase(iNOS) using PET and 18F-NOS in post heart transplant patients (5 women and 5 men) undergoing endomyocardial biopsy as part of their normal post-transplant evaluation. Kinetic data of the tracer will be compared with the heart tissue measurements of iNOS measured by immunohistochemistry.~[18F](+/-)NOS: Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis"
11366281|NCT01058642|BG000|Baseline|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.~Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period."
11366282|NCT01058642|BG001|Baseline|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.~Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
11366283|NCT01058642|BG002|Baseline|Treatment Sequence 3: Placebo Then ADL5747|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.~ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods."
11366284|NCT01058642|BG003|Baseline|Treatment Sequence 4: ADL5747 Then Placebo|"ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days during 1 of 2 Treatment Periods.~Placebo: Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
11366285|NCT01058642|BG004|Baseline|Total|Total of all reporting groups
11366286|NCT01058642|FG000|Participant Flow|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days."
11366287|NCT01058642|FG001|Participant Flow|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID).~At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days.~Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
11366288|NCT01058642|FG002|Participant Flow|Treatment Sequence 3: Placebo Then ADL5747|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week"
11366289|NCT01058642|FG003|Participant Flow|Treatment Sequence 4: ADL5747 Then Placebo|"During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
11366290|NCT01058642|OG000|Outcome|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
11366291|NCT01058642|OG001|Outcome|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
11366292|NCT01058642|OG002|Outcome|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
10962740|NCT00868231|EG001|Reported Event|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
10962741|NCT00868231|EG002|Reported Event|Placebo|Placebo via inhalation
11366293|NCT01058642|EG000|Reported Event|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
11366294|NCT01058642|EG001|Reported Event|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
11366295|NCT01058642|EG002|Reported Event|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
11366296|NCT01065818|BG000|Baseline|Fluoro-L-Thymidine|"Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.~Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.~Data on age (per age categories) and race/ethnicity was not available for these 6 subjects. Only sex was available."
11366297|NCT01065818|FG000|Participant Flow|Fluoro-L-Thymidine|"Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.~Fluoro-L-Thymidine (FLT): 4-dimensional (4D)-Positron Emission Tomography (PET)/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery."
11366298|NCT01065818|OG000|Outcome|Fluoro-L-Thymidine|"Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.~Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery."
11366299|NCT01065818|EG000|Reported Event|Fluoro-L-Thymidine|"Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.~Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.~Only 5 subjects were followed for AEs/SAEs since one subject withdrew consent prior to any participation in the study."
11366300|NCT01051921|BG000|Baseline|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
11366301|NCT01051921|FG000|Participant Flow|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
11366302|NCT01051921|OG000|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
11366303|NCT01051921|EG000|Reported Event|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
11366304|NCT01048125|BG000|Baseline|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
11366305|NCT01048125|BG001|Baseline|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
11366306|NCT01048125|BG002|Baseline|Total|Total of all reporting groups
11366307|NCT01048125|FG000|Participant Flow|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
11366308|NCT01048125|FG001|Participant Flow|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation~Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity~Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.~The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
11366309|NCT01048125|OG000|Outcome|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
11366310|NCT01048125|OG001|Outcome|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation~Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity~Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.~The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
11366311|NCT01048125|EG000|Reported Event|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
11366312|NCT01048125|EG001|Reported Event|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
11366313|NCT01056315|BG000|Baseline|GRT3983Y|
11366314|NCT01056315|BG001|Baseline|Placebo|
11366315|NCT01056315|BG002|Baseline|Total|Total of all reporting groups
11366316|NCT01056315|FG000|Participant Flow|GRT3983Y|
11366317|NCT01056315|FG001|Participant Flow|Placebo|
11366318|NCT01056315|OG000|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
11366319|NCT01056315|OG001|Outcome|Placebo|Participants randomly assigned to receive placebo.
11366320|NCT01056315|EG000|Reported Event|GRT3983Y|
11366321|NCT01056315|EG001|Reported Event|Placebo|
11366322|NCT01058369|BG000|Baseline|Deferasirox|Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
11366323|NCT01058369|FG000|Participant Flow|Deferasirox|Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
11366324|NCT01058369|OG000|Outcome|Deferasirox|Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
11366325|NCT01058369|EG000|Reported Event|Deferasirox|Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
11366326|NCT01048723|BG000|Baseline|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
11366327|NCT01048723|FG000|Participant Flow|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
11366328|NCT01048723|OG000|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
11366329|NCT01048723|EG000|Reported Event|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
11366330|NCT01053221|BG000|Baseline|MPA Monotherapy|"Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy~Mycophenolic Acid: Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months"
11366331|NCT01053221|BG001|Baseline|Control: MPA and CNI|"Subjects will continue with their current immunosuppressive regimen of MPA (mycophenolate mofetil or mycophenolate sodium) and calcineurin inhibitor (cyclosporine or tacrolimus)~Standard of Care: CNI and MPA: Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months"
11366332|NCT01053221|BG002|Baseline|Total|Total of all reporting groups
11366333|NCT01053221|FG000|Participant Flow|MPA Monotherapy|"Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy~Mycophenolic Acid: Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months"
11366334|NCT01053221|FG001|Participant Flow|Control: MPA and CNI|"Subjects will continue with their current immunosuppressive regimen of MPA (mycophenolate mofetil or mycophenolate sodium) and calcineurin inhibitor (cyclosporine or tacrolimus)~Standard of Care: CNI and MPA: Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months"
11366335|NCT01053221|OG000|Outcome|MPA Monotherapy|"Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy~Mycophenolic Acid: Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months"
10962742|NCT00868296|BG000|Baseline|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
11366336|NCT01053221|OG001|Outcome|Control: MPA and CNI|"Subjects will continue with their current immunosuppressive regimen of MPA (mycophenolate mofetil or mycophenolate sodium) and calcineurin inhibitor (cyclosporine or tacrolimus)~Standard of Care: CNI and MPA: Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months"
11366337|NCT01053221|EG000|Reported Event|MPA Monotherapy|"Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy~Mycophenolic Acid: Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months"
11366338|NCT01053221|EG001|Reported Event|Control: MPA and CNI|"Subjects will continue with their current immunosuppressive regimen of MPA (mycophenolate mofetil or mycophenolate sodium) and calcineurin inhibitor (cyclosporine or tacrolimus)~Standard of Care: CNI and MPA: Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months"
11366339|NCT01038752|BG000|Baseline|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
11366340|NCT01038752|BG001|Baseline|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
11366341|NCT01038752|BG002|Baseline|Total|Total of all reporting groups
11366342|NCT01038752|FG000|Participant Flow|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin, Docetaxel, Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
11366343|NCT01038752|FG001|Participant Flow|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo, Docetaxel, Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
11366344|NCT01038752|OG000|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
11366345|NCT01038752|OG001|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
11366346|NCT01038752|EG000|Reported Event|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
11366347|NCT01038752|EG001|Reported Event|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
11366348|NCT01050218|BG000|Baseline|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
11366349|NCT01050218|FG000|Participant Flow|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
11366350|NCT01050218|OG000|Outcome|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
11366351|NCT01050218|EG000|Reported Event|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
11366352|NCT01045694|BG000|Baseline|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
11366353|NCT01045694|FG000|Participant Flow|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
11366354|NCT01045694|OG000|Outcome|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
11366355|NCT01045694|EG000|Reported Event|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution~8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group."
11366356|NCT01035944|BG000|Baseline|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
11366357|NCT01035944|BG001|Baseline|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
11366358|NCT01035944|BG002|Baseline|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
11377105|NCT00972179|EG007|Reported Event|Placebo|Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
11366359|NCT01035944|BG003|Baseline|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
11366360|NCT01035944|BG004|Baseline|Total|Total of all reporting groups
11366361|NCT01035944|FG000|Participant Flow|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
11366362|NCT01035944|FG001|Participant Flow|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
11366363|NCT01035944|FG002|Participant Flow|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
11366364|NCT01035944|FG003|Participant Flow|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
11366365|NCT01035944|OG000|Outcome|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
11366366|NCT01035944|OG001|Outcome|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
11366367|NCT01035944|OG002|Outcome|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
11366368|NCT01035944|OG003|Outcome|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
11366369|NCT01035944|EG000|Reported Event|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
11366370|NCT01035944|EG001|Reported Event|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
11189222|NCT02118831|FG002|Participant Flow|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
11366371|NCT01035944|EG002|Reported Event|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
11366372|NCT01035944|EG003|Reported Event|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
11366373|NCT01031628|BG000|Baseline|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366374|NCT01031628|BG001|Baseline|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366375|NCT01031628|BG002|Baseline|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366376|NCT01031628|BG003|Baseline|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366377|NCT01031628|BG004|Baseline|Total|Total of all reporting groups
11366378|NCT01031628|FG000|Participant Flow|400 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366379|NCT01031628|FG001|Participant Flow|600 or 800 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366380|NCT01031628|FG002|Participant Flow|400 mg for Patients With Imatinib Blood Levels ≥ 1100|"Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366381|NCT01031628|FG003|Participant Flow|400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366382|NCT01031628|OG000|Outcome|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366383|NCT01031628|OG001|Outcome|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366384|NCT01031628|OG002|Outcome|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366385|NCT01031628|OG003|Outcome|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366386|NCT01031628|EG000|Reported Event|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366387|NCT01031628|EG001|Reported Event|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366388|NCT01031628|EG002|Reported Event|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11189223|NCT02118831|OG000|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
11366389|NCT01031628|EG003|Reported Event|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
11366390|NCT01030757|BG000|Baseline|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
11366391|NCT01030757|FG000|Participant Flow|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
11366392|NCT01030757|OG000|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
11377106|NCT04360187|BG000|Baseline|Vehicle Twice a Day (BID)|Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
11377107|NCT04360187|BG001|Baseline|Crisaborole 2% Twice a Day (BID)|Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
11366393|NCT01030757|EG000|Reported Event|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
11366394|NCT01035073|BG000|Baseline|Duloxetine|Duloxetine: 30-60 mg daily for 8 weeks
11366395|NCT01035073|FG000|Participant Flow|Duloxetine|Duloxetine: 30-60 mg daily for 8 weeks
11366396|NCT01035073|OG000|Outcome|Duloxetine|Duloxetine: 30-60 mg daily for 8 weeks
11366397|NCT01035073|EG000|Reported Event|Duloxetine|Duloxetine: 30-60 mg daily for 8 weeks
11366398|NCT01031550|BG000|Baseline|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
11366399|NCT01031550|BG001|Baseline|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
11366400|NCT01031550|BG002|Baseline|Total|Total of all reporting groups
11366401|NCT01031550|FG000|Participant Flow|Standard Anesthetic Management|standard anesthetic management propofol 100-150mcg/kg/min
11366402|NCT01031550|FG001|Participant Flow|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane, anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
11366403|NCT01031550|OG000|Outcome|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
11366404|NCT01031550|OG001|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
11366405|NCT01031550|OG000|Outcome|Standard Anesthetic Management|standard anesthetic management
11366406|NCT01031550|OG001|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
11366407|NCT01031550|EG000|Reported Event|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
11366408|NCT01031550|EG001|Reported Event|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
11366409|NCT01030198|BG000|Baseline|Fresh Surgical Scars|"Treatment of scars~Device: Revlite"
11366410|NCT01030198|BG001|Baseline|Mature Scars|"Treatment of scars~Device: Revlite"
11189224|NCT02118831|OG001|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
11366411|NCT01030198|BG002|Baseline|Total|Total of all reporting groups
11366412|NCT01030198|FG000|Participant Flow|Fresh Surgical Scars|Device: RevLite (Laser Treatment)
11366413|NCT01030198|FG001|Participant Flow|Mature Scars|Device: RevLite (Laser Treatment)
11366414|NCT01030198|OG000|Outcome|Fresh Surgical Scars|"Treatment of scars~RevLite (Laser Treatment)"
11366415|NCT01030198|OG001|Outcome|Mature Scars|"Treatment of scars~RevLite (Laser Treatment)"
11366416|NCT01030198|EG000|Reported Event|Fresh Surgical Scars|"Treatment of scars~Device: Revlite"
11366417|NCT01030198|EG001|Reported Event|Mature Scars|"Treatment of scars~Device: Revlite"
11366418|NCT01028300|BG000|Baseline|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
11366419|NCT01028300|FG000|Participant Flow|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
11366420|NCT01028300|OG000|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
11366421|NCT01028300|EG000|Reported Event|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
11366422|NCT01025271|BG000|Baseline|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
11366423|NCT01025271|FG000|Participant Flow|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
11366424|NCT01025271|OG000|Outcome|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
11366425|NCT01025271|OG000|Outcome|PK Sampling|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
11377108|NCT04360187|BG002|Baseline|Total|Total of all reporting groups
11366426|NCT01025271|EG000|Reported Event|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
11366427|NCT01022398|BG000|Baseline|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
11366428|NCT01022398|BG001|Baseline|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
11366429|NCT01022398|BG002|Baseline|Total|Total of all reporting groups
11366430|NCT01022398|FG000|Participant Flow|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
11366431|NCT01022398|FG001|Participant Flow|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
11366432|NCT01022398|OG000|Outcome|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
11366433|NCT01022398|OG001|Outcome|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
11366434|NCT01022398|EG000|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
11366435|NCT01019980|BG000|Baseline|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
11366436|NCT01019980|BG001|Baseline|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
11366437|NCT01019980|BG002|Baseline|Total|Total of all reporting groups
11366438|NCT01019980|FG000|Participant Flow|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
11366439|NCT01019980|FG001|Participant Flow|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
11366440|NCT01019980|OG000|Outcome|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
11366441|NCT01019980|OG001|Outcome|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
11366442|NCT01019980|EG000|Reported Event|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
11366443|NCT01019980|EG001|Reported Event|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
11366444|NCT01025492|BG000|Baseline|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
11366445|NCT01025492|FG000|Participant Flow|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
11366446|NCT01025492|OG000|Outcome|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
11366447|NCT01025492|EG000|Reported Event|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
11366448|NCT01017263|BG000|Baseline|Open Label Vyvanse|All subjects receive Vyvanse.
11366449|NCT01017263|FG000|Participant Flow|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (Vyvanse). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
11366450|NCT01017263|OG000|Outcome|Vyvanse Open Label|Eligible subjects were dispensed open label LDX (VyvanseTM). All subjects started at 20 mg once a day dose and were titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level was allowed.
11240139|NCT02476448|EG003|Reported Event|Sodium Fluorescein|"Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.~Sodium Fluorescein: Administered intravenously and assessed during cystoscopy"
11366451|NCT01017263|EG000|Reported Event|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
11366452|NCT01020903|BG000|Baseline|Aprepitant|Aprepitant: 40 mg po pre-op
11366453|NCT01020903|BG001|Baseline|Placebo|Placebo: Orally, pre-op
11366454|NCT01020903|BG002|Baseline|Total|Total of all reporting groups
11366455|NCT01020903|FG000|Participant Flow|Aprepitant|Aprepitant: 40 mg po pre-op
11366456|NCT01020903|FG001|Participant Flow|Placebo|Placebo: Orally, pre-op
11366457|NCT01020903|OG000|Outcome|Aprepitant|Aprepitant: 40 mg po pre-op
11366458|NCT01020903|OG001|Outcome|Placebo|Placebo: Orally, pre-op
11366459|NCT01020903|EG000|Reported Event|Aprepitant|"Aprepitant: 40 mg po pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
11366460|NCT01020903|EG001|Reported Event|Placebo|"Placebo: Orally, pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
11366461|NCT01023620|BG000|Baseline|Pioglitazone|"10 male patients with lipodystrophy taking daily Pioglitazone 45 mg~Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks."
11366462|NCT01023620|BG001|Baseline|Observation/Comparison|"10 male patients with lipodystrophy not taking daily Pioglitazone~Observation: Participants will be observed for 16 weeks but will not receive drug"
11366463|NCT01023620|BG002|Baseline|Total|Total of all reporting groups
11366464|NCT01023620|FG000|Participant Flow|Pioglitazone|"10 male patients with lipodystrophy taking daily Pioglitazone 45 mg~Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks."
11366465|NCT01023620|FG001|Participant Flow|Observation/Comparison|"10 male patients with lipodystrophy not taking daily Pioglitazone~Observation: Participants will be observed for 16 weeks but will not receive drug"
11366466|NCT01023620|OG000|Outcome|Pioglitazone|"10 male patients with lipodystrophy taking daily Pioglitazone 45 mg~Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks."
11366467|NCT01023620|OG001|Outcome|Observation/Comparison|"10 male patients with lipodystrophy not taking daily Pioglitazone~Observation: Participants will be observed for 16 weeks but will not receive drug"
11366468|NCT01023620|EG000|Reported Event|Pioglitazone|"10 male patients with lipodystrophy taking daily Pioglitazone 45 mg~Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks."
11366469|NCT01023620|EG001|Reported Event|Observation/Comparison|"10 male patients with lipodystrophy not taking daily Pioglitazone~Observation: Participants will be observed for 16 weeks but will not receive drug"
11366470|NCT01018810|BG000|Baseline|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
11366471|NCT01018810|BG001|Baseline|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366472|NCT01018810|BG002|Baseline|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366473|NCT01018810|BG003|Baseline|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366474|NCT01018810|BG004|Baseline|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366475|NCT01018810|BG005|Baseline|Total|Total of all reporting groups
11366476|NCT01018810|FG000|Participant Flow|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
11366477|NCT01018810|FG001|Participant Flow|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366478|NCT01018810|FG002|Participant Flow|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366479|NCT01018810|FG003|Participant Flow|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366480|NCT01018810|FG004|Participant Flow|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366481|NCT01018810|OG000|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
11366482|NCT01018810|OG001|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366483|NCT01018810|OG002|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366484|NCT01018810|OG003|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366485|NCT01018810|OG004|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
11366486|NCT01018810|EG000|Reported Event|180 mg LY2525623|
11366487|NCT01018810|EG001|Reported Event|Subcutaneous Placebo|
11366488|NCT01018810|EG002|Reported Event|3 mg LY2525623|
11366489|NCT01018810|EG003|Reported Event|30 mg LY2525623|
11366490|NCT01018810|EG004|Reported Event|90 mg LY2525623|
11366491|NCT01016561|BG000|Baseline|Arm I|"Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.~intracavitary balloon brachytherapy~external beam radiation therapy~intensity-modulated radiation therapy~radiation therapy treatment planning/simulation~3-dimensional conformal radiation therapy~Cisplatin"
11366492|NCT01016561|FG000|Participant Flow|Arm I|"Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.~intracavitary balloon brachytherapy~external beam radiation therapy~intensity-modulated radiation therapy~radiation therapy treatment planning/simulation~3-dimensional conformal radiation therapy~Cisplatin"
11366493|NCT01016561|OG000|Outcome|Arm I|"Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.~intracavitary balloon brachytherapy~external beam radiation therapy~intensity-modulated radiation therapy~radiation therapy treatment planning/simulation~3-dimensional conformal radiation therapy~Cisplatin"
11366494|NCT01016561|EG000|Reported Event|Arm I|"Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.~intracavitary balloon brachytherapy~external beam radiation therapy~intensity-modulated radiation therapy~radiation therapy treatment planning/simulation~3-dimensional conformal radiation therapy~Cisplatin"
11366495|NCT01016847|BG000|Baseline|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
11366496|NCT01016847|BG001|Baseline|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
11366497|NCT01016847|BG002|Baseline|Total|Total of all reporting groups
11366498|NCT01016847|FG000|Participant Flow|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
11366499|NCT01016847|FG001|Participant Flow|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
11366500|NCT01016847|OG000|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
11366501|NCT01016847|OG001|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
11366502|NCT01016847|EG000|Reported Event|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
11366503|NCT01016847|EG001|Reported Event|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
11366504|NCT01014767|BG000|Baseline|Standard Arm (1)|Age/Sex unknown- PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available Alternating chemotherapy cycles with etoposide 100 mg/m2 over 1 hour on days 1-5, carboplatin 350 mg/m2 over 2 hours on day 2 and 3, vincristine 1.5 mg/m2 on day 5 alternating with: etoposide 100 mg/m2 over 1 hour on days 1-5, cyclophosphamide 1 g/m2 over 1 hour on day 2 and 3, vincristine 1.5 mg/m2 on day 5. Six blocks are given in 4 week intervals (day1 to day1). Radiation is given between the second and the third cycle only to a small subgroup of patients defined by age histology staging and response to the first to cycles of chemotherapy.
11366505|NCT01014767|BG001|Baseline|Doxorubicin/Cisplatin Arm (2)|Age/Sex unknown- PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available Doxorubicin 25 mg/m²/day over 12 hrs on days 1-3, Dactinomycin 45 µg/kg/day (max. 2 mg), i.v. on day 1, and Cisplatin 70 mg/m²/d over 6 hrs on day 4, and Vincristine 1.5 mg/m²/day (max. 2 mg), i.v. on days 8, 15. An identical second cycle is started on day 28 if the side effects allow it. The further treatment is identical to the standard arm with four more cycles of chemotherapy following radiation in some of the patients in all treatment arms.
11366506|NCT01014767|BG002|Baseline|Methotrexate Arm (3)|Age/Sex unknown- PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available Methotrexate 5g/m^2 over 24 hours with leucovorin rescue at hour 42 given three times on days 1 15 and 29. The further treatment is identical in all four treatment arms.
11366507|NCT01014767|BG003|Baseline|Temozolomide Irinotecan Arm (4)|Age/Sex unknown- PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available Temozolomide is given at 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day x 5 days as one hour infusions. Two of these cycles are followed by the common radiation - four cycle chemotherapy protocol.
11366508|NCT01014767|BG004|Baseline|Total|Total of all reporting groups
11366509|NCT01014767|FG000|Participant Flow|Standard Arm (1)|Alternating chemotherapy cycles with etoposide 100 mg/m2 over 1 hour on days 1-5, carboplatin 350 mg/m2 over 2 hours on day 2 and 3, vincristine 1.5 mg/m2 on day 5 alternating with: etoposide 100 mg/m2 over 1 hour on days 1-5, cyclophosphamide 1 g/m2 over 1 hour on day 2 and 3, vincristine 1.5 mg/m2 on day 5. Six blocks are given in 4 week intervals (day1 to day1). Radiation is given between the second and the third cycle only to a small subgroup of patients defined by age histology staging and response to the first to cycles of chemotherapy.
11366510|NCT01014767|FG001|Participant Flow|Doxorubicin/Cisplatin Arm (2)|Doxorubicin 25 mg/m²/day over 12 hrs on days 1-3, Dactinomycin 45 µg/kg/day (max. 2 mg), i.v. on day 1, and Cisplatin 70 mg/m²/d over 6 hrs on day 4, and Vincristine 1.5 mg/m²/day (max. 2 mg), i.v. on days 8, 15. An identical second cycle is started on day 28 if the side effects allow it. The further treatment is identical to the standard arm with four more cycles of chemotherapy following radiation in some of the patients in all treatment arms.
11366511|NCT01014767|FG002|Participant Flow|Methotrexate Arm (3)|Methotrexate 5g/m^2 over 24 hours with leucovorin rescue at hour 42 given three times on days 1 15 and 29. The further treatment is identical in all four treatment arms.
11366512|NCT01014767|FG003|Participant Flow|Temozolomide Irinotecan Arm (4)|Temozolomide is given at 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day x 5 days as one hour infusions. Two of these cycles are followed by the common radiation - four cycle chemotherapy protocol.
11366513|NCT01014767|OG000|Outcome|Standard Arm (1)|Alternating chemotherapy cycles with etoposide 100 mg/m2 over 1 hour on days 1-5, carboplatin 350 mg/m2 over 2 hours on day 2 and 3, vincristine 1.5 mg/m2 on day 5 alternating with: etoposide 100 mg/m2 over 1 hour on days 1-5, cyclophosphamide 1 g/m2 over 1 hour on day 2 and 3, vincristine 1.5 mg/m2 on day 5. Six blocks are given in 4 week intervals (day1 to day1). Radiation is given between the second and the third cycle only to a small subgroup of patients defined by age histology staging and response to the first to cycles of chemotherapy.
11189225|NCT02118831|OG002|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
11366514|NCT01014767|OG001|Outcome|Doxorubicin/Cisplatin Arm (2)|Doxorubicin 25 mg/m²/day over 12 hrs on days 1-3, Dactinomycin 45 µg/kg/day (max. 2 mg), i.v. on day 1, and Cisplatin 70 mg/m²/d over 6 hrs on day 4, and Vincristine 1.5 mg/m²/day (max. 2 mg), i.v. on days 8, 15. An identical second cycle is started on day 28 if the side effects allow it. The further treatment is identical to the standard arm with four more cycles of chemotherapy following radiation in some of the patients in all treatment arms.
11366515|NCT01014767|OG002|Outcome|Methotrexate Arm (3)|Methotrexate 5g/m^2 over 24 hours with leucovorin rescue at hour 42 given three times on days 1 15 and 29. The further treatment is identical in all four treatment arms.
11366516|NCT01014767|OG003|Outcome|Temozolomide Irinotecan Arm (4)|Temozolomide is given at 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day x 5 days as one hour infusions. Two of these cycles are followed by the common radiation - four cycle chemotherapy protocol.
11366517|NCT01014767|EG000|Reported Event|Standard Arm (1)|Alternating chemotherapy cycles with etoposide 100 mg/m2 over 1 hour on days 1-5, carboplatin 350 mg/m2 over 2 hours on day 2 and 3, vincristine 1.5 mg/m2 on day 5 alternating with: etoposide 100 mg/m2 over 1 hour on days 1-5, cyclophosphamide 1 g/m2 over 1 hour on day 2 and 3, vincristine 1.5 mg/m2 on day 5. Six blocks are given in 4 week intervals (day1 to day1). Radiation is given between the second and the third cycle only to a small subgroup of patients defined by age histology staging and response to the first to cycles of chemotherapy.
11377109|NCT04360187|FG000|Participant Flow|Vehicle Twice a Day (BID)|Vehicle was applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1 and new atopic dermatitis (AD) lesions that appear after the Baseline/Day 1.
11366518|NCT01014767|EG001|Reported Event|Doxorubicin/Cisplatin Arm (2)|Doxorubicin 25 mg/m²/day over 12 hrs on days 1-3, Dactinomycin 45 µg/kg/day (max. 2 mg), i.v. on day 1, and Cisplatin 70 mg/m²/d over 6 hrs on day 4, and Vincristine 1.5 mg/m²/day (max. 2 mg), i.v. on days 8, 15. An identical second cycle is started on day 28 if the side effects allow it. The further treatment is identical to the standard arm with four more cycles of chemotherapy following radiation in some of the patients in all treatment arms.
11366519|NCT01014767|EG002|Reported Event|Methotrexate Arm (3)|Methotrexate 5g/m^2 over 24 hours with leucovorin rescue at hour 42 given three times on days 1 15 and 29. The further treatment is identical in all four treatment arms.
11366520|NCT01014767|EG003|Reported Event|Temozolomide Irinotecan Arm (4)|Temozolomide is given at 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day x 5 days as one hour infusions. Two of these cycles are followed by the common radiation - four cycle chemotherapy protocol.
11366521|NCT01013701|BG000|Baseline|All Participants|"nasal steroid fluticasone furoate: nasal steroid spray~OR~nasal spray vehicle without drug placebo: nasal steroid vehicle without drug"
11366522|NCT01013701|FG000|Participant Flow|All Participants|"nasal steroid fluticasone furoate: nasal steroid spray~OR~nasal spray vehicle without drug placebo: nasal steroid vehicle without drug"
11366523|NCT01013701|OG000|Outcome|Nasal Steroid|nasal steroid fluticasone furoate: nasal steroid spray
11366524|NCT01013701|OG001|Outcome|Placebo|nasal spray vehicle without drug placebo: nasal steroid vehicle without drug
11366525|NCT01013701|EG000|Reported Event|All Participants|"nasal steroid fluticasone furoate: nasal steroid spray~OR~nasal spray vehicle without drug placebo: nasal steroid vehicle without drug"
11366526|NCT01012414|BG000|Baseline|Enrolled|Total number participants consentedand enrolled
11366527|NCT01012414|FG000|Participant Flow|All Participants|The participants could have been randomized to one of the 2 arms; study drug or placebo. The study was never unblinded before termination.
11366528|NCT01012414|OG000|Outcome|All Participants|no arm /group title is provided as there was no enrollment.
11366529|NCT01012414|OG000|Outcome|Alll Participants|no arm /group title is provided as there was no enrollment.
11366530|NCT01012414|OG000|Outcome|All Participants|No arm/group title is provided
11366531|NCT01012414|EG000|Reported Event|All Participants|All participants in the study.
11366532|NCT01011634|BG000|Baseline|Moderate Sedation|
11366533|NCT01011634|BG001|Baseline|Oral Medication|
11366534|NCT01011634|BG002|Baseline|Total|Total of all reporting groups
11366535|NCT01011634|FG000|Participant Flow|Moderate Sedation|
11366536|NCT01011634|FG001|Participant Flow|Oral Medication|
11366537|NCT01011634|OG000|Outcome|Moderate Sedation|
11366538|NCT01011634|OG001|Outcome|Oral Medication|
11366539|NCT01011634|EG000|Reported Event|Oral Medications|
11366540|NCT01011634|EG001|Reported Event|IV Medications|
11366541|NCT01009931|BG000|Baseline|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
11366542|NCT01009931|FG000|Participant Flow|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
11366543|NCT01009931|OG000|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
11366544|NCT01009931|EG000|Reported Event|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
11366545|NCT01001390|BG000|Baseline|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
11366546|NCT01001390|FG000|Participant Flow|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
11366547|NCT01001390|FG001|Participant Flow|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
11366548|NCT01001390|OG000|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
11377110|NCT04360187|FG001|Participant Flow|Crisaborole 2% Twice a Day (BID)|Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
11366549|NCT01001390|EG000|Reported Event|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
11366550|NCT01001390|EG001|Reported Event|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
11366551|NCT01006018|BG000|Baseline|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
11366552|NCT01006018|BG001|Baseline|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
11366553|NCT01006018|BG002|Baseline|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
11366554|NCT01006018|BG003|Baseline|Total|Total of all reporting groups
11366555|NCT01006018|FG000|Participant Flow|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
11366556|NCT01006018|FG001|Participant Flow|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
11366557|NCT01006018|FG002|Participant Flow|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
11366558|NCT01006018|OG000|Outcome|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
11366559|NCT01006018|OG001|Outcome|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
11366560|NCT01006018|OG002|Outcome|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
11366561|NCT01006018|EG000|Reported Event|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
11366562|NCT01006018|EG001|Reported Event|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
11366563|NCT01006018|EG002|Reported Event|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
11366564|NCT01004510|BG000|Baseline|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
11366565|NCT01004510|FG000|Participant Flow|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy. Zoledronic acid dose per package insert for up to 4 cycles.
11366566|NCT01004510|OG000|Outcome|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
11189226|NCT02118831|EG000|Reported Event|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
11366567|NCT01004510|EG000|Reported Event|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
11366568|NCT01005914|BG000|Baseline|Group 1|"Drug:cyclophosphamide Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily~Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours~Drug:imatinib mesylate 600 mg/day~Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion~Drug: methylprednisolone Day 1-3: 50mg IV BID~Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV~Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
11366569|NCT01005914|FG000|Participant Flow|Group 1|"Drug:cyclophosphamide-Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours Drug:imatinib mesylate 600 mg/day Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion Drug: methylprednisolone Day 1-3: 50mg IV BID Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
11366570|NCT01005914|OG000|Outcome|Group 1|Cy D1- 3: 300 m g/m2 IV- 6 doses, mesna 600 mg/ m2 /day continuous IV D 1-3, ARAC D 2 & 3: 3g/m2 IV q12 X 4, Dex D1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV, imatinib mesylate 600 mg/day, MTX D1: 1g/ m2 200 mg/ m2 load IV plus 800 mg/ m2, methylprednisolone D 1-3: 50mg IV BID, pegaspargase D3/D4: 2,500 IU/ m2 IV, vincristine sulfate D4 & 11: 2 mg IV, Cy: D 1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day, continuous infusion D 1-3. ARAC D 2 & 3: 3g/m2 IV q12 X 4, dex: D 1-4; 11-14: 40 mg daily, doxorubicin hydrochloride: D 4: 50 mg/m2 IV, imatinib mesylate: 600 mg/day, MTX: D 1: 1g/ m2 200 mg/ m2load IV plus 800 mg/ m2 IV, methylprednisolone: D 1-3: 50mg IV BID, pegaspargase: D 3/D4: 2,500 IU/ m2 IV, vincristine sulfate: D 4 & 11: 2 mg IV, pharmacological study: C1A: pre-dose between Days 1 to 4, C1A: D11 or 12., C1A: D18 or 19, C 1A: D25 or 26, C1A: D32 or 33 C1B: pre-dose between D1-3, C1B: D1 or 11 C1B: D17 or 18, C1B: D24 or 25 C1B: D31 or 32
11366571|NCT01005914|EG000|Reported Event|Group 1|"cyclophosphamide D1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day cont. IV D1-3, cytarabine D2 & 3: 3g/m2 IV, dexD1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV~Drug:imatinib mesylate 600 mg/day~Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion~Drug: methylprednisolone Day 1-3: 50mg IV BID~Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV~Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
11366572|NCT00996333|BG000|Baseline|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
11366573|NCT00996333|FG000|Participant Flow|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
11366574|NCT00996333|OG000|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
11366575|NCT00996333|EG000|Reported Event|Gemzar, Taxotere, Xeloda|"Gemcitabine, Docetaxel, Capecitabine:~Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
11366576|NCT00998738|BG000|Baseline|Overall|
11366577|NCT00998738|FG000|Participant Flow|Overall|
11366578|NCT00998738|OG000|Outcome|Overall|
11189227|NCT02118831|EG001|Reported Event|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
11189228|NCT02118831|EG002|Reported Event|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
11189229|NCT02118896|BG000|Baseline|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
11366579|NCT00998738|EG000|Reported Event|Overall|
11366580|NCT00996502|BG000|Baseline|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
11366581|NCT00996502|FG000|Participant Flow|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
11377111|NCT04360187|OG000|Outcome|Vehicle Twice a Day (BID)|Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
11189230|NCT02118896|BG001|Baseline|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
11189231|NCT02118896|BG002|Baseline|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
11189232|NCT02118896|BG003|Baseline|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
11189233|NCT02118896|BG004|Baseline|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
11189234|NCT02118896|BG005|Baseline|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
11189235|NCT02118896|BG006|Baseline|PMR-EC-1105|"Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.~Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to"
11189236|NCT02118896|BG007|Baseline|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
11189237|NCT02118896|BG008|Baseline|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
11189238|NCT02118896|BG009|Baseline|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
11189239|NCT02118896|BG010|Baseline|Total|Total of all reporting groups
11189240|NCT02118896|FG000|Participant Flow|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
11189241|NCT02118896|FG001|Participant Flow|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
11189242|NCT02118896|FG002|Participant Flow|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
11366582|NCT00996502|OG000|Outcome|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
11366583|NCT00996502|EG000|Reported Event|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
11366584|NCT00997386|BG000|Baseline|Busulfan, and Melphalan, and Alemtuzumab|"Three drug regimen using busulfan, and melphalan, and alemtuzumab.~Busulfan, and melphalan, and alemtuzumab: intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).~Intravenous melphalan 100 mg/m2 on day -3.~Intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1."
11366585|NCT00997386|FG000|Participant Flow|Busulfan, and Melphalan, and Alemtuzumab|"Three drug regimen using busulfan, and melphalan, and alemtuzumab.~Busulfan, and melphalan, and alemtuzumab: intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).~Intravenous melphalan 100 mg/m2 on day -3.~Intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1."
11366586|NCT00997386|OG000|Outcome|Busulfan, and Melphalan, and Alemtuzumab|"Three drug regimen using busulfan, and melphalan, and alemtuzumab.~Busulfan, and melphalan, and alemtuzumab: intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).~Intravenous melphalan 100 mg/m2 on day -3.~Intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1."
11366587|NCT00997386|EG000|Reported Event|Busulfan, and Melphalan, and Alemtuzumab|"Three drug regimen using busulfan, and melphalan, and alemtuzumab.~Busulfan, and melphalan, and alemtuzumab: intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).~Intravenous melphalan 100 mg/m2 on day -3.~Intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1."
11366588|NCT00985738|BG000|Baseline|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
11366589|NCT00985738|BG001|Baseline|Placebo|This group received a placebo followed by 3D mapping biopsy.
11366590|NCT00985738|BG002|Baseline|Total|Total of all reporting groups
11366591|NCT00985738|FG000|Participant Flow|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
11366592|NCT00985738|FG001|Participant Flow|Placebo|This group received a placebo followed by 3D mapping biopsy.
11366593|NCT00985738|OG000|Outcome|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
11189243|NCT02118896|FG003|Participant Flow|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
11366594|NCT00985738|OG001|Outcome|Placebo|This group received a placebo followed by 3D mapping biopsy.
11366595|NCT00985738|EG000|Reported Event|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
11366596|NCT00985738|EG001|Reported Event|Placebo|This group received a placebo followed by 3D mapping biopsy.
11366597|NCT00986999|BG000|Baseline|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
11366598|NCT00986999|FG000|Participant Flow|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
11366599|NCT00986999|OG000|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
11366600|NCT00986999|EG000|Reported Event|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
11366601|NCT00989937|BG000|Baseline|All Participants|
11366602|NCT00989937|FG000|Participant Flow|All Participants|
11366603|NCT00989937|OG000|Outcome|All Participants|
11366604|NCT00989937|EG000|Reported Event|All Participants|
11366605|NCT00986947|BG000|Baseline|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
11377112|NCT04360187|OG001|Outcome|Crisaborole 2% Twice a Day (BID)|Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
11189244|NCT02118896|FG004|Participant Flow|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
11366606|NCT00986947|FG000|Participant Flow|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
11366607|NCT00986947|OG000|Outcome|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
11366608|NCT00986947|EG000|Reported Event|IvIg With Rituximab|"Intravenous immunoglobulin (IVIg) and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
11366609|NCT00982995|BG000|Baseline|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
11366610|NCT00982995|FG000|Participant Flow|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
11366611|NCT00982995|OG000|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
11189245|NCT02118896|FG005|Participant Flow|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
11189246|NCT02118896|FG006|Participant Flow|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
11189247|NCT02118896|FG007|Participant Flow|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
11189248|NCT02118896|FG008|Participant Flow|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
11189249|NCT02118896|FG009|Participant Flow|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
11189250|NCT02118896|OG000|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
11189251|NCT02118896|OG001|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
11366612|NCT00982995|EG000|Reported Event|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
11189252|NCT02118896|OG002|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
11189253|NCT02118896|OG003|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
11189254|NCT02118896|OG004|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
11189255|NCT02118896|OG005|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
11189256|NCT02118896|OG006|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
11189257|NCT02118896|OG007|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
11189258|NCT02118896|OG008|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
11189259|NCT02118896|OG009|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
11366613|NCT00984490|BG000|Baseline|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
11366614|NCT00984490|FG000|Participant Flow|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
11366615|NCT00984490|OG000|Outcome|Metformin|Metformin: 850 mg orally (PO) twice a day for 7-21 days, discontinued 24-36 hrs prior to surgery
11366616|NCT00984490|OG000|Outcome|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery)
11366617|NCT00984490|EG000|Reported Event|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
11366618|NCT00986310|BG000|Baseline|Fluoxetine|"Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization bringing the total dose of fluoxetine to 40 mg/day in patients randomized to receive this medication. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.~Fluoxetine: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued."
11366619|NCT00986310|BG001|Baseline|Placebo|"Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.~Placebo: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued."
11366620|NCT00986310|BG002|Baseline|Total|Total of all reporting groups
11366621|NCT00986310|FG000|Participant Flow|Fluoxetine|"Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization bringing the total dose of fluoxetine to 40 mg/day in patients randomized to receive this medication. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.~Fluoxetine: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued."
11366622|NCT00986310|FG001|Participant Flow|Placebo|"Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.~Placebo: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued."
11366623|NCT00986310|OG000|Outcome|Fluoxetine|"Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization bringing the total dose of fluoxetine to 40 mg/day in patients randomized to receive this medication. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.~Fluoxetine: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued."
11366624|NCT00986310|OG001|Outcome|Placebo|"Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.~Placebo: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued."
11366625|NCT00986310|EG000|Reported Event|Fluoxetine|"Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization bringing the total dose of fluoxetine to 40 mg/day in patients randomized to receive this medication. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.~Fluoxetine: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued."
11377113|NCT04360187|EG000|Reported Event|Vehicle Twice a Day (BID)|Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
11189260|NCT02118896|OG009|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study. There were no reported BCAR in subjects in the previous study PMR-EC-1210, Kaplan-Meier estimate not applicable.
11366626|NCT00986310|EG001|Reported Event|Placebo|"Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.~Placebo: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued."
11366627|NCT00978874|BG000|Baseline|All Subjects|"fludeoxyglucose F 18~fluorine F 18 EF5"
11366628|NCT00978874|FG000|Participant Flow|All Subjects|"fludeoxyglucose F 18~fluorine F 18 EF5"
11366629|NCT00978874|OG000|Outcome|All Subjects|"fludeoxyglucose F 18~fluorine F 18 EF5"
11366630|NCT00978874|EG000|Reported Event|All Subjects|"fludeoxyglucose F 18~fluorine F 18 EF5"
11366631|NCT00983645|BG000|Baseline|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
11366632|NCT00983645|BG001|Baseline|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
11366633|NCT00983645|BG002|Baseline|Total|Total of all reporting groups
11366634|NCT00983645|FG000|Participant Flow|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
11366635|NCT00983645|FG001|Participant Flow|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
11189261|NCT02118896|EG000|Reported Event|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
11366636|NCT00983645|OG000|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
11366637|NCT00983645|OG001|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
11366638|NCT00983645|EG000|Reported Event|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
11366639|NCT00983645|EG001|Reported Event|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
11189262|NCT02118896|EG001|Reported Event|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
11189263|NCT02118896|EG002|Reported Event|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
11376280|NCT00980460|OG000|Outcome|High-risk Group (Regimen W)|"(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376281|NCT00980460|OG001|Outcome|High-risk Group (Regimen H)|"Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376282|NCT00980460|EG000|Reported Event|Very Low-risk Group|"Patients undergo surgery and then receive no further treatment.~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
11376283|NCT00980460|EG001|Reported Event|Low-risk Group (Regimen T)|"Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11377114|NCT04360187|EG001|Reported Event|Crisaborole 2% Twice a Day (BID)|Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
11366640|NCT00979147|BG000|Baseline|Modular Metal Tibial Baseplate|"Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA~TKA surgery with modular polished tibial baseplate/XLK design: TKA surgery with modular polished tibial baseplate/XLK design~P.F.C.® Sigma Knee System: P.F.C.® Sigma Knee System with modular XLK poly"
11366641|NCT00979147|BG001|Baseline|All Polyethylene Tibial Baseplate|"Patients who were randomized to receive the nonmodular APT/GVF TKA design.~TKA surgery with the nonmodular APT/GVF design: TKA surgery with the nonmodular APT/GVF design~P.F.C.® Sigma Knee System: P.F.C. ® Sigma Knee System with an all-poly GVF tibia"
11366642|NCT00979147|BG002|Baseline|Total|Total of all reporting groups
11366643|NCT00979147|FG000|Participant Flow|Modular Metal Tibial Baseplate|"Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA~TKA surgery with modular polished tibial baseplate/XLK design: TKA surgery with modular polished tibial baseplate/XLK design~P.F.C.® Sigma Knee System: P.F.C.® Sigma Knee System with modular XLK poly"
11366644|NCT00979147|FG001|Participant Flow|All Polyethylene Tibial Baseplate|"Patients who were randomized to receive the nonmodular APT/GVF TKA design.~TKA surgery with the nonmodular APT/GVF design: TKA surgery with the nonmodular APT/GVF design~P.F.C.® Sigma Knee System: P.F.C. ® Sigma Knee System with an all-poly GVF tibia"
11366645|NCT00979147|OG000|Outcome|Modular Metal Tibial Baseplate|"Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA~TKA surgery with modular polished tibial baseplate/XLK design: TKA surgery with modular polished tibial baseplate/XLK design~P.F.C.® Sigma Knee System: P.F.C.® Sigma Knee System with modular XLK poly"
11366646|NCT00979147|OG001|Outcome|All Polyethylene Tibial Baseplate|"Patients who were randomized to receive the nonmodular APT/GVF TKA design.~TKA surgery with the nonmodular APT/GVF design: TKA surgery with the nonmodular APT/GVF design~P.F.C.® Sigma Knee System: P.F.C. ® Sigma Knee System with an all-poly GVF tibia"
11366647|NCT00979147|EG000|Reported Event|Modular Metal Tibial Baseplate|"Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA~TKA surgery with modular polished tibial baseplate/XLK design: TKA surgery with modular polished tibial baseplate/XLK design~P.F.C.® Sigma Knee System: P.F.C.® Sigma Knee System with modular XLK poly"
11366648|NCT00979147|EG001|Reported Event|All Polyethylene Tibial Baseplate|"Patients who were randomized to receive the nonmodular APT/GVF TKA design.~TKA surgery with the nonmodular APT/GVF design: TKA surgery with the nonmodular APT/GVF design~P.F.C.® Sigma Knee System: P.F.C. ® Sigma Knee System with an all-poly GVF tibia"
11366649|NCT00967447|BG000|Baseline|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
11366650|NCT00967447|FG000|Participant Flow|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
11366651|NCT00967447|OG000|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
11366652|NCT00967447|EG000|Reported Event|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
11366653|NCT00970606|BG000|Baseline|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
10963952|NCT00875056|FG002|Participant Flow|Other Disease|Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
11366654|NCT00970606|BG001|Baseline|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
11366655|NCT00970606|BG002|Baseline|Total|Total of all reporting groups
11366656|NCT00970606|FG000|Participant Flow|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
11366657|NCT00970606|FG001|Participant Flow|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
11366658|NCT00970606|OG000|Outcome|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
11366659|NCT00970606|OG001|Outcome|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
11366660|NCT00970606|EG000|Reported Event|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
11366661|NCT00970606|EG001|Reported Event|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
11366662|NCT00979550|BG000|Baseline|Aldara Cream|"The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.~Imiquimod (Aldara): .5 oz cream nightly to the affected area"
11366663|NCT00979550|BG001|Baseline|Non-medicated Petroleum Cream|"The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.~non-medicated petroleum cream: .5 oz cream nightly to the affected area"
11366664|NCT00979550|BG002|Baseline|Total|Total of all reporting groups
11377115|NCT04025632|BG000|Baseline|Placebo|Participants were randomized to receive daily SC doses of matching placebo during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study.
11366665|NCT00979550|FG000|Participant Flow|Aldara Cream|"The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.~Imiquimod (Aldara): .5 oz cream nightly to the affected area"
11366666|NCT00979550|FG001|Participant Flow|Non-medicated Petroleum Cream|"The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.~non-medicated petroleum cream: .5 oz cream nightly to the affected area"
11366667|NCT00979550|OG000|Outcome|Aldara Cream|Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
11366668|NCT00979550|OG001|Outcome|Non-medicated Petroleum Cream|Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
11366669|NCT00979550|EG000|Reported Event|Aldara Cream|Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
11366670|NCT00979550|EG001|Reported Event|Non-medicated Petroleum Cream|Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
11366671|NCT00966992|BG000|Baseline|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
11366672|NCT00966992|BG001|Baseline|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.~Zoledronic acid"
11189264|NCT02118896|EG003|Reported Event|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
11366673|NCT00966992|BG002|Baseline|Total|Total of all reporting groups
11366674|NCT00966992|FG000|Participant Flow|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
11366675|NCT00966992|FG001|Participant Flow|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.~Zoledronic acid"
11366676|NCT00966992|OG000|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
11366677|NCT00966992|OG001|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
11366678|NCT00966992|EG000|Reported Event|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
11366679|NCT00966992|EG001|Reported Event|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
11366680|NCT00981370|BG000|Baseline|Group 1|First group of subjects to be enrolled.
11366681|NCT00981370|FG000|Participant Flow|Group One|No enrollment
11366682|NCT00981370|OG000|Outcome|Group 1|First group of subjects enrolled.
11366683|NCT00981370|EG000|Reported Event|Group 1|No patients enrolled
11366684|NCT00975611|BG000|Baseline|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
11366685|NCT00975611|FG000|Participant Flow|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here.
11366686|NCT00975611|OG000|Outcome|All Consented Subjects|
11366687|NCT00975611|EG000|Reported Event|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
11366688|NCT00978419|BG000|Baseline|Rosuvastatin|"Rosuvastatin~Rosuvastatin: Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days"
11366689|NCT00978419|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo administered every day for up to 28 days"
11366690|NCT00978419|BG002|Baseline|Total|Total of all reporting groups
11366691|NCT00978419|FG000|Participant Flow|Rosuvastatin|"Rosuvastatin~Rosuvastatin: Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days"
11366692|NCT00978419|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo administered every day for up to 28 days"
11366693|NCT00978419|OG000|Outcome|Rosuvastatin|"Rosuvastatin~Rosuvastatin: Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days"
11366694|NCT00978419|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo administered every day for up to 28 days"
11366695|NCT00978419|EG000|Reported Event|Rosuvastatin|"Rosuvastatin~Rosuvastatin: Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days"
11366696|NCT00978419|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo administered every day for up to 28 days"
11366697|NCT00973856|BG000|Baseline|PURELL VF481 Left Hand/ Placebo Right Hand|"Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants~PURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed"
11366698|NCT00973856|BG001|Baseline|Placebo Solution Left Hand/ PURELL VF481 Right Hand|"Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants~One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed~Placebo Comparator: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed"
11366699|NCT00973856|BG002|Baseline|Total|Total of all reporting groups
11366700|NCT00973856|FG000|Participant Flow|PURELL VF481 Left Hand/ Placebo Right Hand|"Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants~PURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed"
11366701|NCT00973856|FG001|Participant Flow|Placebo Solution Left Hand/ PURELL VF481 Right Hand|"Warts are equally distributed between products so that an equal number of warts treated on each person One (1) product will be assigned to each hand to minimize treatment confusion for the participants~One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed~Placebo Comparator: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed"
11366702|NCT00973856|OG000|Outcome|Purell VF481|Active Ingredient: 70% ethanol
11366703|NCT00973856|EG000|Reported Event|Purell VF481|Active Ingredient: 70% ethanol
11366704|NCT00973856|EG001|Reported Event|Placebo|15% alcohol formulation that aesthetically resembles VF481
11366705|NCT00979810|BG000|Baseline|18F-FLT PET Scan|"This is a pilot study intended to collect preliminary data on 15 patients diagnosed with untreated high-grade glioma who are scheduled to undergo surgical resection.~18F-FLT PET Scan: The patient will undergo MRI and 18F-FLT PET scans of the brain. A IV catheter will be placed in a superficial hand or arm vein for administration of 18F-FLT (approximately 370 MBq), prepared by the MSKCC Radiochemistry Core Facility. A second venous catheter will be placed in the opposite hand or arm for venous blood sampling. If a central venous catheter is present, it will be used for blood sampling or radiopharmaceutical administration, and only a single venous catheter will be placed. Sequential blood samples may be obtained following 18F-FLT infusion for assaying whole blood and plasma radioactivity. All catheters will be removed at the end of the day."
11366706|NCT00979810|FG000|Participant Flow|18F-FLT PET Scan|"This is a pilot study intended to collect preliminary data on 15 patients diagnosed with untreated high-grade glioma who are scheduled to undergo surgical resection.~18F-FLT PET Scan: The patient will undergo MRI and 18F-FLT PET scans of the brain. A IV catheter will be placed in a superficial hand or arm vein for administration of 18F-FLT (approximately 370 MBq), prepared by the MSKCC Radiochemistry Core Facility. A second venous catheter will be placed in the opposite hand or arm for venous blood sampling. If a central venous catheter is present, it will be used for blood sampling or radiopharmaceutical administration, and only a single venous catheter will be placed. Sequential blood samples may be obtained following 18F-FLT infusion for assaying whole blood and plasma radioactivity. All catheters will be removed at the end of the day."
11366707|NCT00979810|OG000|Outcome|18F-FLT PET Scan|"This is a pilot study intended to collect preliminary data on 15 patients diagnosed with untreated high-grade glioma who are scheduled to undergo surgical resection.~18F-FLT PET Scan: The patient will undergo MRI and 18F-FLT PET scans of the brain. A IV catheter will be placed in a superficial hand or arm vein for administration of 18F-FLT (approximately 370 MBq), prepared by the MSKCC Radiochemistry Core Facility. A second venous catheter will be placed in the opposite hand or arm for venous blood sampling. If a central venous catheter is present, it will be used for blood sampling or radiopharmaceutical administration, and only a single venous catheter will be placed. Sequential blood samples may be obtained following 18F-FLT infusion for assaying whole blood and plasma radioactivity. All catheters will be removed at the end of the day."
11377116|NCT04025632|BG001|Baseline|Zilucoplan 0.3 mg/kg|Participants were randomized to receive daily SC doses of zilucoplan 0.3 mg/kg during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study.
11377117|NCT04025632|BG002|Baseline|Total|Total of all reporting groups
11366708|NCT00979810|EG000|Reported Event|18F-FLT PET Scan|"This is a pilot study intended to collect preliminary data on 15 patients diagnosed with untreated high-grade glioma who are scheduled to undergo surgical resection.~18F-FLT PET Scan: The patient will undergo MRI and 18F-FLT PET scans of the brain. A IV catheter will be placed in a superficial hand or arm vein for administration of 18F-FLT (approximately 370 MBq), prepared by the MSKCC Radiochemistry Core Facility. A second venous catheter will be placed in the opposite hand or arm for venous blood sampling. If a central venous catheter is present, it will be used for blood sampling or radiopharmaceutical administration, and only a single venous catheter will be placed. Sequential blood samples may be obtained following 18F-FLT infusion for assaying whole blood and plasma radioactivity. All catheters will be removed at the end of the day."
11366709|NCT00974922|BG000|Baseline|Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3|"Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.~Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks."
11366710|NCT00974922|FG000|Participant Flow|Aliskiren and Vitamin D3 AND Aliskiren Versus Vitamin D3|Study stopped prematurely. Intervention groups combined because data were never unblinded.
11366711|NCT00974922|OG000|Outcome|Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3|"Phase I: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.~Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks."
11366712|NCT00974922|EG000|Reported Event|Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3|"Phase I: Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.~Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks."
11366713|NCT00976339|BG000|Baseline|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly, for 1 year
11366714|NCT00976339|BG001|Baseline|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly, for 1 year
11366715|NCT00976339|BG002|Baseline|Total|Total of all reporting groups
11366716|NCT00976339|FG000|Participant Flow|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly for 1 year.
11366717|NCT00976339|FG001|Participant Flow|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly for one year
11366718|NCT00976339|OG000|Outcome|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly 1 year
11366719|NCT00976339|OG001|Outcome|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly 1 year
11366720|NCT00976339|OG000|Outcome|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly, for 1 year
11366721|NCT00976339|OG001|Outcome|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly, for 1 year
11366722|NCT00976339|EG000|Reported Event|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly 1 year
11366723|NCT00976339|EG001|Reported Event|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly 1 year
11366724|NCT00965146|BG000|Baseline|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
11366725|NCT00965146|FG000|Participant Flow|Scorpio® CR Device|All subjects were implanted with the Scorpio® CR Total Knee System Study Device
11366726|NCT00965146|OG000|Outcome|Scorpio® CR Device|All subjects received the Scorpio® CR Device
11366727|NCT00965146|EG000|Reported Event|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
11366728|NCT00972023|BG000|Baseline|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
11366729|NCT00972023|FG000|Participant Flow|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
11366730|NCT00972023|OG000|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
11366731|NCT00972023|OG000|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
11366732|NCT00972023|OG000|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
11366733|NCT00972023|EG000|Reported Event|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
11366734|NCT00970736|BG000|Baseline|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
11366735|NCT00970736|FG000|Participant Flow|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
11366736|NCT00970736|OG000|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
11366737|NCT00970736|EG000|Reported Event|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
11366738|NCT00957827|BG000|Baseline|Keflex|"keflex 500mg twice a day for five days~keflex: keflex 500 mg BID 5 days"
11366739|NCT00957827|BG001|Baseline|Placebo|"placebo 500mg twice a day for five days~placebo: placebo BID for five days"
11366740|NCT00957827|BG002|Baseline|Total|Total of all reporting groups
11366741|NCT00957827|FG000|Participant Flow|Keflex|"keflex 500mg twice a day for five days~keflex: keflex 500 mg BID 5 days"
11366742|NCT00957827|FG001|Participant Flow|Placebo|"placebo 500mg twice a day for five days~placebo: placebo BID for five days"
11366743|NCT00957827|OG000|Outcome|Keflex|"keflex 500mg twice a day for five days~keflex: keflex 500 mg BID 5 days"
11366744|NCT00957827|OG001|Outcome|Placebo|"placebo 500mg twice a day for five days~placebo: placebo BID for five days"
11366745|NCT00957827|EG000|Reported Event|Keflex|"keflex 500mg twice a day for five days~keflex: keflex 500 mg BID 5 days"
11366746|NCT00957827|EG001|Reported Event|Placebo|"placebo 500mg twice a day for five days~placebo: placebo BID for five days"
11366747|NCT00953329|BG000|Baseline|Group 1|
11366748|NCT00953329|FG000|Participant Flow|Alefacept Treated|
11366749|NCT00953329|OG000|Outcome|Alefacept|50 mg
11366750|NCT00953329|EG000|Reported Event|Group 1|
11366751|NCT00965055|BG000|Baseline|All Study Participants|
11366752|NCT00965055|FG000|Participant Flow|All Study Participants|
11366753|NCT00965055|OG000|Outcome|All Study Participants|
11366754|NCT00965055|EG000|Reported Event|All Study Participants|
11366755|NCT00962429|BG000|Baseline|Lipoic Acid|"alpha lipoic acid~lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study."
11366756|NCT00962429|BG001|Baseline|Placebo|"sugar pill~lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study."
11366757|NCT00962429|BG002|Baseline|Total|Total of all reporting groups
11366758|NCT00962429|FG000|Participant Flow|Lipoic Acid|"alpha lipoic acid~lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study."
11366759|NCT00962429|FG001|Participant Flow|Placebo|"sugar pill~lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study."
11366760|NCT00962429|OG000|Outcome|Lipoic Acid|"alpha lipoic acid~lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study."
11366761|NCT00962429|OG001|Outcome|Placebo|"sugar pill~lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study."
11366762|NCT00962429|EG000|Reported Event|Lipoic Acid|"alpha lipoic acid~lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study."
11366763|NCT00962429|EG001|Reported Event|Placebo|"sugar pill~lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study."
11366764|NCT00958893|BG000|Baseline|25 mg Proellex|25 mg Proellex daily
11366765|NCT00958893|FG000|Participant Flow|25 mg Proellex|25 mg Proellex: one 25 mg capsules
11366766|NCT00958893|OG000|Outcome|25 mg Proellex|25 mg Proellex: one 25 mg capsules
11366767|NCT00958893|EG000|Reported Event|25 mg Proellex|25 mg Proellex: one 25 mg capsules
11366768|NCT00966654|BG000|Baseline|All Study Participants|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
11366769|NCT00966654|FG000|Participant Flow|GLP-1|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.~OR~Placebo (saline)"
11366770|NCT00966654|OG000|Outcome|GLP-1|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
11366771|NCT00966654|OG001|Outcome|Saline|"Saline~Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
11366772|NCT00966654|EG000|Reported Event|GLP-1|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
11366773|NCT00966654|EG001|Reported Event|Saline|"Saline~Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
11366774|NCT00960154|BG000|Baseline|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
11366775|NCT00960154|BG001|Baseline|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
11366776|NCT00960154|BG002|Baseline|Total|Total of all reporting groups
11366777|NCT00960154|FG000|Participant Flow|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
11366778|NCT00960154|FG001|Participant Flow|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
11366779|NCT00960154|OG000|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
11366780|NCT00960154|OG001|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
11366781|NCT00960154|EG000|Reported Event|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
11366782|NCT00960154|EG001|Reported Event|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
11366783|NCT00960752|BG000|Baseline|Group 1: GP100 and MAGE-3 + R848|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
11189265|NCT02118896|EG004|Reported Event|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
11189266|NCT02118896|EG005|Reported Event|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
11189267|NCT02118896|EG006|Reported Event|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
11189268|NCT02118896|EG007|Reported Event|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
11189269|NCT02118896|EG008|Reported Event|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
11189270|NCT02118896|EG009|Reported Event|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
11189271|NCT02118961|BG000|Baseline|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
11189272|NCT02118961|BG001|Baseline|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
11189273|NCT02118961|BG002|Baseline|Total|Total of all reporting groups
11189274|NCT02118961|FG000|Participant Flow|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
11189275|NCT02118961|FG001|Participant Flow|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
11189276|NCT02118961|OG000|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
11189277|NCT02118961|OG001|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
11189278|NCT02118961|EG000|Reported Event|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
11189279|NCT02118961|EG001|Reported Event|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
11189280|NCT02119026|BG000|Baseline|A: XELIRI + BEV Followed by XELOX + BEV|"capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV)~Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance~At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.~Capecitabine: 800mg/m2 bid d1-14~± 1000 mg/m2 bid,days 1-14 q3w: maintenance~Bevacizumab: 7,5 mg/kg given on d1 q3w~Irinotecan: 200mg/m2 iv. d 1 q3w ."
11189281|NCT02119026|BG001|Baseline|B: XELOX + BEV Followed by XELIRI + BEV|"capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV)~Arm B:~Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance~At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.~Capecitabine: 1000mg/m2 bid d1-14,~Bevacizumab: 7,5 mg/kg given on d1 q3w~Oxaliplatin: 130mg/m2 iv. d 1 q3w"
11189282|NCT02119026|BG002|Baseline|Total|Total of all reporting groups
11189283|NCT02119026|FG000|Participant Flow|A: XELIRI + BEV Followed by XELOX + BEV|"capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))~Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance~At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.~Capecitabine: 800mg/m2 bid d1-14~± 1000 mg/m2 bid,days 1-14 q3w: maintenance~Bevacizumab: 7,5 mg/kg given on d1 q3w~Irinotecan: 200mg/m2 iv. d 1 q3w ."
11189284|NCT02119026|FG001|Participant Flow|B: XELOX + BEV Followed by XELIRI + BEV|"capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))~Arm B:~Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance~At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.~Capecitabine: 1000mg/m2 bid d1-14,~Bevacizumab: 7,5 mg/kg given on d1 q3w~Oxaliplatin: 130mg/m2 iv. d 1 q3w"
11189285|NCT02119026|OG000|Outcome|A: XELIRI + BEV Followed by XELOX + BEV|"capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))~Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance~At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.~Capecitabine: 800mg/m2 bid d1-14~± 1000 mg/m2 bid,days 1-14 q3w: maintenance~Bevacizumab: 7,5 mg/kg given on d1 q3w~Irinotecan: 200mg/m2 iv. d 1 q3w ."
11189286|NCT02119026|OG001|Outcome|B: XELOX + BEV Followed by XELIRI + BEV|"capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))~Arm B:~Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance~At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.~Capecitabine: 1000mg/m2 bid d1-14,~Bevacizumab: 7,5 mg/kg given on d1 q3w~Oxaliplatin: 130mg/m2 iv. d 1 q3w"
11189287|NCT02119026|EG000|Reported Event|A: XELIRI + BEV Followed by XELOX + BEV|"capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))~Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance~At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.~Capecitabine: 800mg/m2 bid d1-14~± 1000 mg/m2 bid,days 1-14 q3w: maintenance~Bevacizumab: 7,5 mg/kg given on d1 q3w~Irinotecan: 200mg/m2 iv. d 1 q3w ."
11189288|NCT02119026|EG001|Reported Event|B: XELOX + BEV Followed by XELIRI + BEV|"capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))~Arm B:~Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance~At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.~Capecitabine: 1000mg/m2 bid d1-14,~Bevacizumab: 7,5 mg/kg given on d1 q3w~Oxaliplatin: 130mg/m2 iv. d 1 q3w"
11366784|NCT00960752|BG001|Baseline|Group 2: GP100 and MAGE-3|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.
11366785|NCT00960752|BG002|Baseline|Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
11366786|NCT00960752|BG003|Baseline|Total|Total of all reporting groups
11366787|NCT00960752|FG000|Participant Flow|Group 1: GP100 and MAGE-3 + R848|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
11366788|NCT00960752|FG001|Participant Flow|Group 2: GP100 and MAGE-3|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.
11366789|NCT00960752|FG002|Participant Flow|Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
11366790|NCT00960752|OG000|Outcome|Group 1: GP100 and MAGE-3 + R848|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
11366791|NCT00960752|OG001|Outcome|Group 2: GP100 and MAGE-3|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.
11366792|NCT00960752|OG002|Outcome|Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
11366793|NCT00960752|EG000|Reported Event|Group 1: GP100 and MAGE-3 + R848|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
11366794|NCT00960752|EG001|Reported Event|Group 2: GP100 and MAGE-3|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.
11366795|NCT00960752|EG002|Reported Event|Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848|1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.
11366796|NCT00958347|BG000|Baseline|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
11366797|NCT00958347|FG000|Participant Flow|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem.
11366798|NCT00958347|OG000|Outcome|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
11366799|NCT00958347|EG000|Reported Event|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
11366800|NCT00954187|BG000|Baseline|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
11366801|NCT00954187|BG001|Baseline|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
11366802|NCT00954187|BG002|Baseline|Total|Total of all reporting groups
11366803|NCT00954187|FG000|Participant Flow|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
11366804|NCT00954187|FG001|Participant Flow|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
11366805|NCT00954187|OG000|Outcome|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
11366806|NCT00954187|OG001|Outcome|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
11366807|NCT00954187|EG000|Reported Event|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
11366808|NCT00954187|EG001|Reported Event|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
11366809|NCT00953615|BG000|Baseline|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
11366810|NCT00953615|FG000|Participant Flow|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
11366811|NCT00953615|OG000|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
11366812|NCT00953615|EG000|Reported Event|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
11366813|NCT00947284|BG000|Baseline|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
11366814|NCT00947284|FG000|Participant Flow|Women-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
11366815|NCT00947284|FG001|Participant Flow|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
11366816|NCT00947284|OG000|Outcome|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
11377118|NCT04025632|FG000|Participant Flow|Placebo|Participants were randomized to receive daily SC doses of matching placebo during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study.
10963953|NCT00875056|OG000|Outcome|Follicular Lymphoma (FL)|Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
11336676|NCT03570047|EG002|Reported Event|Dabigatran|OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336677|NCT03570047|EG003|Reported Event|Rivaroxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336678|NCT03570047|EG004|Reported Event|Edoxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated edoxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period.
11336679|NCT03570255|BG000|Baseline|RD SET Neo SpO2|"All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.~RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor."
11336680|NCT03570255|FG000|Participant Flow|RD SET Neo SpO2|"All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.~RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor."
11336681|NCT03570255|OG000|Outcome|RD SET Neo SpO2|"All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.~RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor."
11336682|NCT03570255|EG000|Reported Event|RD SET Neo SpO2|"All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.~RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor."
11336683|NCT03570476|BG000|Baseline|Treatment (Olaparib, Radical Prostatectomy)|"Participants receive olaparib PO BID for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.~Olaparib: Given PO~Radical Prostatectomy: Undergo surgery"
11336684|NCT03570476|FG000|Participant Flow|Treatment (Olaparib, Radical Prostatectomy)|"Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.~Olaparib: Given PO~Radical Prostatectomy: Undergo surgery"
11336685|NCT03570476|OG000|Outcome|Treatment (Olaparib, Radical Prostatectomy)|"Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.~Olaparib: Given PO~Radical Prostatectomy: Undergo surgery"
11336686|NCT03570476|OG000|Outcome|Treatment (Olaparib, Radical Prostatectomy)|"Participants receive olaparib PO BID for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.~Olaparib: Given PO~Radical Prostatectomy: Undergo surgery"
11336687|NCT03570476|EG000|Reported Event|Treatment (Olaparib, Radical Prostatectomy)|"Participants receive olaparib PO BID for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.~Olaparib: Given PO~Radical Prostatectomy: Undergo surgery"
11336688|NCT03570554|BG000|Baseline|Treatment A-D-C-B|Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by placebo for 4 days; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
11336689|NCT03570554|BG001|Baseline|Treatment B-C-D-A|Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by placebo for 4 days; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
11336690|NCT03570554|BG002|Baseline|Treatment C-A-B-D|Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by placebo for 4 days. Treatment periods were separated by a washout period of 3 to 7 days.
11336691|NCT03570554|BG003|Baseline|Treatment D-B-A-C|Participants received placebo for 4 days; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
11336692|NCT03570554|BG004|Baseline|Total|Total of all reporting groups
11336693|NCT03570554|FG000|Participant Flow|Treatment A-D-C-B|Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by placebo for 4 days; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
11336694|NCT03570554|FG001|Participant Flow|Treatment B-C-D-A|Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by placebo for 4 days; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
11366817|NCT00947284|EG000|Reported Event|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
11366818|NCT00957034|BG000|Baseline|Placebo|placebo patch
11366819|NCT00957034|BG001|Baseline|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
11366820|NCT00957034|BG002|Baseline|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
11366821|NCT00957034|BG003|Baseline|Total|Total of all reporting groups
11366822|NCT00957034|FG000|Participant Flow|Placebo|placebo patch
11366823|NCT00957034|FG001|Participant Flow|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
11366824|NCT00957034|FG002|Participant Flow|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
11366825|NCT00957034|OG000|Outcome|Placebo|placebo patch
11366826|NCT00957034|OG001|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
11189289|NCT02119104|BG000|Baseline|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
11189290|NCT02119104|FG000|Participant Flow|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
11366827|NCT00957034|OG002|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
11366828|NCT00957034|EG000|Reported Event|Placebo|placebo patch
11366829|NCT00957034|EG001|Reported Event|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
11366830|NCT00957034|EG002|Reported Event|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
11366831|NCT00949988|BG000|Baseline|All Participants|This study only enrolled three subjects and all three subjects withdrew before study completion.
11366832|NCT00949988|FG000|Participant Flow|All Participants|This study only enrolled three subjects and all three subjects withdrew before study completion.
11366833|NCT00949988|OG000|Outcome|All Participants|This study only enrolled three subjects and all three subjects withdrew before study completion.
11366834|NCT00949988|EG000|Reported Event|All Participants|This study only enrolled three subjects and all three subjects withdrew before study completion.
11366835|NCT00948194|BG000|Baseline|No Nitric Oxide|This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics
11366836|NCT00948194|BG001|Baseline|Nitric Oxide|"Will receive Nitric oxide and other standard inhaled anesthetics~Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery"
11366837|NCT00948194|BG002|Baseline|Total|Total of all reporting groups
11366838|NCT00948194|FG000|Participant Flow|No Nitric Oxide|This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics
11366839|NCT00948194|FG001|Participant Flow|Nitric Oxide|"Will receive Nitric oxide and other standard inhaled anesthetics~Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery"
11366840|NCT00948194|OG000|Outcome|No Nitric Oxide|This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics
11366841|NCT00948194|OG001|Outcome|Nitric Oxide|"Will receive Nitric oxide and other standard inhaled anesthetics~Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery"
11366842|NCT00948194|EG000|Reported Event|No Nitric Oxide|This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics
11366843|NCT00948194|EG001|Reported Event|Nitric Oxide|"Will receive Nitric oxide and other standard inhaled anesthetics~Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery"
11366844|NCT00946985|BG000|Baseline|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
11366845|NCT00946985|FG000|Participant Flow|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
11366846|NCT00946985|OG000|Outcome|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
11366847|NCT00946985|EG000|Reported Event|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
11366848|NCT00950183|BG000|Baseline|Foot and Ankle Surgery|Our target enrollment was 82 participants. We only enrolled 36 participants. The study was terminated due to low enrollment. As a result, patients were never randomized.
11366849|NCT00950183|FG000|Participant Flow|Foot and Ankle Surgery|
11366850|NCT00950183|OG000|Outcome|Foot and Ankle Surgery|
11366851|NCT00950183|EG000|Reported Event|Foot and Ankle Surgery|
11366852|NCT00950690|BG000|Baseline|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
11366853|NCT00950690|FG000|Participant Flow|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
11366854|NCT00950690|OG000|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
11366855|NCT00950690|EG000|Reported Event|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
11366856|NCT00944229|BG000|Baseline|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
11366857|NCT00944229|FG000|Participant Flow|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
11366858|NCT00944229|OG000|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
11366859|NCT00944229|EG000|Reported Event|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
11377119|NCT04025632|FG001|Participant Flow|Zilucoplan 0.3 mg/kg|Participants were randomized to receive daily SC doses of zilucoplan 0.3 mg/kg during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study.
11366860|NCT00941928|BG000|Baseline|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
11366861|NCT00941928|FG000|Participant Flow|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
11366862|NCT00941928|OG000|Outcome|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
11366863|NCT00941928|EG000|Reported Event|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
11366864|NCT00949403|BG000|Baseline|Obese Females (Pre-bariatric Surgery)|Twenty obese females (18-45 years of age, BMI > or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years.
11366865|NCT00949403|FG000|Participant Flow|Obese Females (Pre-bariatric Surgery)|Twenty obese females (18-45 years of age, BMI > or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years.
11366866|NCT00949403|OG000|Outcome|Obese Females (Pre-bariatric Surgery)|Twenty obese females (18-45 years of age, BMI > or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years.
11366867|NCT00949403|EG000|Reported Event|Obese Females (Pre-bariatric Surgery)|Twenty obese females (18-45 years of age, BMI > or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years.
11366868|NCT00947791|BG000|Baseline|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
11366869|NCT00947791|BG001|Baseline|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
11366870|NCT00947791|BG002|Baseline|Total|Total of all reporting groups
11366871|NCT00947791|FG000|Participant Flow|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
11366872|NCT00947791|FG001|Participant Flow|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
11366873|NCT00947791|OG000|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
11366874|NCT00947791|OG001|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
11366875|NCT00947791|EG000|Reported Event|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
11366876|NCT00947791|EG001|Reported Event|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
11366877|NCT00947011|BG000|Baseline|All Particpants|"Januvia: 1 tablet 100 mg once a day~OR~Placebo: 1 tablet 100 mg once a day"
11366878|NCT00947011|FG000|Participant Flow|All Participants|"Januvia: 1 tablet 100 mg once a day~OR~Placebo comparator"
11366879|NCT00947011|OG000|Outcome|Januvia|Januvia: 1 tablet 100 mg once a day
11366880|NCT00947011|OG001|Outcome|Placebo|Placebo: 1 tablet 100 mg once a day
11366881|NCT00947011|EG000|Reported Event|Januvia|Januvia: 1 tablet 100 mg once a day
11366882|NCT00947011|EG001|Reported Event|Placebo|Placebo: 1 tablet 100 mg once a day
11366883|NCT00943605|BG000|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11366884|NCT00943605|BG001|Baseline|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
11366885|NCT00943605|BG002|Baseline|Total|Total of all reporting groups
11366886|NCT00943605|FG000|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11366887|NCT00943605|FG001|Participant Flow|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
11366888|NCT00943605|OG000|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11366889|NCT00943605|OG001|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
11366890|NCT00943605|EG000|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
11366891|NCT00943605|EG001|Reported Event|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
11366892|NCT00942409|BG000|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
11366893|NCT00942409|FG000|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
11366894|NCT00942409|OG000|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
11366895|NCT00942409|EG000|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
11366896|NCT00936585|BG000|Baseline|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
11366897|NCT00936585|FG000|Participant Flow|Immunologic Monitoring|All patients who were enrolled in the main study participated in the NIH sub study and underwent a colonoscopy and blood draw for research specimens for immunologic monitoring before and after study drug administration
11366898|NCT00936585|OG000|Outcome|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
11189291|NCT02119104|OG000|Outcome|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
11366899|NCT00936585|EG000|Reported Event|Colonoscopy|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
11366900|NCT00936598|BG000|Baseline|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
11366901|NCT00936598|BG001|Baseline|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
11366902|NCT00936598|BG002|Baseline|Total|Total of all reporting groups
11366903|NCT00936598|FG000|Participant Flow|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
11366904|NCT00936598|FG001|Participant Flow|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
11366905|NCT00936598|OG000|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
11366906|NCT00936598|OG001|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
11366907|NCT00936598|EG000|Reported Event|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
11366908|NCT00936598|EG001|Reported Event|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
11189292|NCT02119104|EG000|Reported Event|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
11366909|NCT00920309|BG000|Baseline|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
11366910|NCT00920309|BG001|Baseline|Standard of Care-Placebo|
11366911|NCT00920309|BG002|Baseline|Total|Total of all reporting groups
11366912|NCT00920309|FG000|Participant Flow|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
11366913|NCT00920309|FG001|Participant Flow|Standard of Care-Placebo|
11366914|NCT00920309|OG000|Outcome|Rapamycin|The study was terminated before any enrolled patients were treated for 2 years.
11366915|NCT00920309|OG001|Outcome|Standard of Care-Placebo|
11366916|NCT00920309|OG000|Outcome|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
11366917|NCT00920309|EG000|Reported Event|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
11366918|NCT00920309|EG001|Reported Event|Standard of Care-Placebo|
11366919|NCT00935649|BG000|Baseline|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
11366920|NCT00935649|FG000|Participant Flow|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
11366921|NCT00935649|OG000|Outcome|Treated Great Toe|Laser treatment of great toe
11366922|NCT00935649|OG001|Outcome|Untreated Great Toe|untreated control great toe
11366923|NCT00935649|EG000|Reported Event|Treated Great Toe|Laser treatment of great toe
11366924|NCT00935649|EG001|Reported Event|Untreated Great Toe|untreated control great toe
11366925|NCT00934791|BG000|Baseline|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
11366926|NCT00934791|BG001|Baseline|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
11366927|NCT00934791|BG002|Baseline|Total|Total of all reporting groups
11366928|NCT00934791|FG000|Participant Flow|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
11366929|NCT00934791|FG001|Participant Flow|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
11366930|NCT00934791|OG000|Outcome|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
11366931|NCT00934791|OG001|Outcome|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
11366932|NCT00934791|EG000|Reported Event|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
11366933|NCT00934791|EG001|Reported Event|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
11366934|NCT00932152|BG000|Baseline|Fulvestrant and Anastrozole Only|
11366935|NCT00932152|BG001|Baseline|Fulvestrant, Anastrozole and Bevacizumab|
11366936|NCT00932152|BG002|Baseline|Total|Total of all reporting groups
11366937|NCT00932152|FG000|Participant Flow|Fulvestrant and Anastrozole Only|
11366938|NCT00932152|FG001|Participant Flow|Fulvestrant, Anastrozole and Bevacizumab|
11366939|NCT00932152|OG000|Outcome|All Participants (Overall Study)|
11366940|NCT00932152|OG000|Outcome|Fulvestrant and Anastrozole Only|
11366941|NCT00932152|OG001|Outcome|Fulvestrant, Anastrozole and Bevacizumab|
11366942|NCT00932152|EG000|Reported Event|All Participants (Overall Study)|
11366943|NCT00928499|BG000|Baseline|Interstim - Continuous Stimulation First, Then Cyclic Stimulation|"Continuous stimulation~Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy"
11366944|NCT00928499|BG001|Baseline|Interstim - Cyclic Stimulation First, Then Continuous Stimulation|"Cyclic stimulation~Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy"
11366945|NCT00928499|BG002|Baseline|Total|Total of all reporting groups
11366946|NCT00928499|FG000|Participant Flow|Continuous Stimulation First, Then Cyclic Stimulation|"Continuous stimulation first, then cyclic stimulation~Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy"
11366947|NCT00928499|FG001|Participant Flow|Cyclic Stimulation First, Then Continuous Stimulation|"Cyclic stimulation first, then continuous stimulation~Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy"
11366948|NCT00928499|OG000|Outcome|Interstim - Continuous, Then Cyclic|"Continuous stimulation~Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy"
11366949|NCT00928499|OG001|Outcome|Interstim - Cyclic, Then Continuous|"Cyclic stimulation~Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy"
11366950|NCT00928499|EG000|Reported Event|Interstim - Continuous, Then Cyclic|Continuous stimulation first, then cyclic stimulation Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
11366951|NCT00928499|EG001|Reported Event|Interstim - Cyclic, Then Continuous|Cyclic stimulation first, then continuous stimulation Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
11366952|NCT00924807|BG000|Baseline|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
11366953|NCT00924807|FG000|Participant Flow|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
11366954|NCT00924807|OG000|Outcome|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
11366955|NCT00924807|EG000|Reported Event|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
11366956|NCT00930787|BG000|Baseline|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
11366957|NCT00930787|BG001|Baseline|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
11366958|NCT00930787|BG002|Baseline|Total|Total of all reporting groups
11366959|NCT00930787|FG000|Participant Flow|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
11366960|NCT00930787|FG001|Participant Flow|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
11366961|NCT00930787|OG000|Outcome|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
11366962|NCT00930787|OG001|Outcome|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
11366963|NCT00930787|EG000|Reported Event|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
11366964|NCT00930787|EG001|Reported Event|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
11366965|NCT00929474|BG000|Baseline|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
11366966|NCT00929474|BG001|Baseline|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
11366967|NCT00929474|BG002|Baseline|Total|Total of all reporting groups
11366968|NCT00929474|FG000|Participant Flow|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
11366969|NCT00929474|FG001|Participant Flow|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
11366970|NCT00929474|OG000|Outcome|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
11366971|NCT00929474|OG001|Outcome|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
11366972|NCT00929474|EG000|Reported Event|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
11366973|NCT00929474|EG001|Reported Event|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
11366974|NCT00925548|BG000|Baseline|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
11366975|NCT00925548|BG001|Baseline|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
11366976|NCT00925548|BG002|Baseline|Total|Total of all reporting groups
11366977|NCT00925548|FG000|Participant Flow|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
11366978|NCT00925548|FG001|Participant Flow|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 grams per liter (g/L) infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
11189293|NCT02119156|BG000|Baseline|Long-term Discontinuation Group|Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.
11189294|NCT02119156|BG001|Baseline|Treatment Control Group|Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189295|NCT02119156|BG002|Baseline|Treatment Holiday Group|Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189296|NCT02119156|BG003|Baseline|Total|Total of all reporting groups
11189297|NCT02119156|FG000|Participant Flow|Long-term Discontinuation Group|Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.
11189298|NCT02119156|FG001|Participant Flow|Treatment Control Group|Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189299|NCT02119156|FG002|Participant Flow|Treatment Holiday Group|Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189300|NCT02119156|OG000|Outcome|Long-term Discontinuation Group|Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.
11189301|NCT02119156|OG001|Outcome|Treatment Control Group|Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189302|NCT02119156|OG002|Outcome|Treatment Holiday Group - Holiday Phase|Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189303|NCT02119156|OG003|Outcome|Treatment Holiday Group - Re-start Phase|Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189304|NCT02119156|OG002|Outcome|Treatment Holiday Group|Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11377120|NCT04025632|OG000|Outcome|Placebo|Participants were randomized to receive daily SC doses of matching placebo during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study.
11377121|NCT04025632|OG001|Outcome|Zilucoplan 0.3 mg/kg|Participants were randomized to receive daily SC doses of zilucoplan 0.3 mg/kg during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study.
11189305|NCT02119156|OG000|Outcome|Treatment Holiday Group - Re-start Phase|Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189306|NCT02119156|OG000|Outcome|Long-term Discontinuation|Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.
11189307|NCT02119156|EG000|Reported Event|Treatment Phase: Long-term Discontinuation Group|Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.
11189308|NCT02119156|EG001|Reported Event|Treatment Phase: Treatment Control Group|Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189309|NCT02119156|EG002|Reported Event|Treatment Phase: Treatment Holiday Group - Holiday Phase|Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189310|NCT02119156|EG003|Reported Event|Treatment Phase: Treatment Holiday Group - Re-start Phase|Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189311|NCT02119156|EG004|Reported Event|Maintenance Phase: Treatment Control|Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189312|NCT02119156|EG005|Reported Event|Maintenance Phase: Treatment Holiday|Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).
11189313|NCT02119260|BG000|Baseline|Cohort 1|Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
11189314|NCT02119260|BG001|Baseline|Cohort 2|Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
11189315|NCT02119260|BG002|Baseline|Cohort 3|Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
11189316|NCT02119260|BG003|Baseline|Cohort 4 (GSK2798745 2.4 mg SD and RD)|Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg . GSK2798745 was administered in capsule formulation
11189317|NCT02119260|BG004|Baseline|Cohort 4 (Placebo RD)|Participants with heart failure received placebo. Placebo was administered in capsule formulation
11189318|NCT02119260|BG005|Baseline|Cohort 5 (GSK2798745 2.4 mg RD)|Participants with heart failure received repeat-doses of GSK2798745 2.4 mg. GSK2798745 was administered in capsule formulation
11189319|NCT02119260|BG006|Baseline|Cohort 5 (Placebo RD)|Participants with heart failure received placebo. Placebo was administered in capsule formulation
11189320|NCT02119260|BG007|Baseline|Total|Total of all reporting groups
11189321|NCT02119260|FG000|Participant Flow|Cohort 1|Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
11377122|NCT04025632|OG000|Outcome|Main Portion: Placebo|Participants were randomized to receive daily SC doses of matching placebo during the 8-week Main Portion of the study.
11377123|NCT04025632|OG001|Outcome|Main Portion: Zilucoplan 0.3 mg/kg|Participants were randomized to receive daily SC doses of zilucoplan 0.3 mg/kg during the 8-week Main Portion of the study.
11366979|NCT00925548|OG000|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
11366980|NCT00925548|OG001|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
11366981|NCT00925548|OG001|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
11366982|NCT00925548|EG000|Reported Event|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
11366983|NCT00925548|EG001|Reported Event|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
11366984|NCT00926575|BG000|Baseline|Active|oral beclomethasone 17,21-dipropionate (BDP)
11366985|NCT00926575|BG001|Baseline|Placebo|
11366986|NCT00926575|BG002|Baseline|Total|Total of all reporting groups
11366987|NCT00926575|FG000|Participant Flow|Active|oral beclomethasone 17,21-dipropionate (BDP)
11366988|NCT00926575|FG001|Participant Flow|Placebo|
11366989|NCT00926575|OG000|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
11366990|NCT00926575|OG001|Outcome|Placebo|
11366991|NCT00926575|EG000|Reported Event|Active|oral beclomethasone 17,21-dipropionate (BDP)
11366992|NCT00926575|EG001|Reported Event|Placebo|
11366993|NCT00911053|BG000|Baseline|Baseline|
11366994|NCT00911053|BG001|Baseline|Melatonin|"Subjects will be administered melatonin.~Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg."
11366995|NCT00911053|BG002|Baseline|Light|Light: Subjects will be exposed to light.
11366996|NCT00911053|BG003|Baseline|Regular Sleep Schedule|Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing.
11366997|NCT00911053|BG004|Baseline|Longitudinal Monitoring|Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
11366998|NCT00911053|BG005|Baseline|Total|Total of all reporting groups
11366999|NCT00911053|FG000|Participant Flow|Baseline|
11367000|NCT00911053|FG001|Participant Flow|Melatonin|"Subjects will be administered melatonin.~Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg."
11367001|NCT00911053|FG002|Participant Flow|Light|Light: Subjects will be exposed to light.
11367002|NCT00911053|FG003|Participant Flow|Regular Sleep Schedule|Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing.
11367003|NCT00911053|FG004|Participant Flow|Longitudinal Monitoring|Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
11367004|NCT00911053|OG000|Outcome|Baseline|
11367005|NCT00911053|OG001|Outcome|Melatonin|"Subjects will be administered melatonin.~Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg."
11367006|NCT00911053|OG002|Outcome|Light|Light: Subjects will be exposed to light.
11367007|NCT00911053|OG003|Outcome|Regular Sleep Schedule|Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing.
11367008|NCT00911053|OG004|Outcome|Longitudinal Monitoring|Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
11367009|NCT00911053|EG000|Reported Event|Baseline|
11367010|NCT00911053|EG001|Reported Event|Melatonin|"Subjects will be administered melatonin.~Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg."
11367011|NCT00911053|EG002|Reported Event|Light|Light: Subjects will be exposed to light.
11367012|NCT00911053|EG003|Reported Event|Regular Sleep Schedule|Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing.
11367013|NCT00911053|EG004|Reported Event|Longitudinal Monitoring|Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
11367014|NCT00918463|BG000|Baseline|All Patients|dasatinib: 100 mg daily dosing
11367015|NCT00918463|FG000|Participant Flow|All Patients|dasatinib: 100 mg daily dosing
11367016|NCT00918463|OG000|Outcome|All Patients|dasatinib: 100 mg daily dosing
11367017|NCT00918463|EG000|Reported Event|All Patients|dasatinib: 100 mg daily dosing
11367018|NCT00913692|BG000|Baseline|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
11367019|NCT00913692|FG000|Participant Flow|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
11367020|NCT00913692|OG000|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.
11367021|NCT00913692|OG000|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
11367022|NCT00913692|EG000|Reported Event|Treatment Phase 1|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
11367023|NCT00913692|EG001|Reported Event|Washout|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
11367024|NCT00913692|EG002|Reported Event|Treatment Phase 2|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
11367025|NCT00918645|BG000|Baseline|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
11367026|NCT00918645|FG000|Participant Flow|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
11367027|NCT00918645|OG000|Outcome|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
11367028|NCT00918645|EG000|Reported Event|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
11367029|NCT00907218|BG000|Baseline|No Data Was Analyzed|
11367030|NCT00907218|FG000|Participant Flow|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
11367031|NCT00907218|OG000|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|Varenicline (Chantix): Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
11367032|NCT00907218|EG000|Reported Event|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
11367033|NCT00895284|BG000|Baseline|Robot|Robotic hysterectomy
11367034|NCT00895284|BG001|Baseline|Standard|Standard hysterectomy
11367035|NCT00895284|BG002|Baseline|Total|Total of all reporting groups
11367036|NCT00895284|FG000|Participant Flow|Robot|Robotic hysterectomy
11367037|NCT00895284|FG001|Participant Flow|Standard|Standard hysterectomy
11367038|NCT00895284|OG000|Outcome|Robot|Robotic hysterectomy
11367039|NCT00895284|OG001|Outcome|Standard|Standard hysterectomy
11367040|NCT00895284|EG000|Reported Event|Robot|Robotic hysterectomy
11367041|NCT00895284|EG001|Reported Event|Standard|Standard hysterectomy
11367042|NCT00897910|BG000|Baseline|Collection of Circulating Blood and Bone Marrow.|
11367043|NCT00897910|FG000|Participant Flow|Collection of Circulating Blood and Bone Marrow.|
11367044|NCT00897910|OG000|Outcome|Collection of Blood and Bone Marrow.|
11367045|NCT00897910|EG000|Reported Event|Collection of Circulating Blood and Bone Marrow.|
11367046|NCT00901303|BG000|Baseline|Early Stage Disease|"Group A~ABVD chemotherapy: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle"
11367047|NCT00901303|BG001|Baseline|Advanced Stage Disease|"Group B~ABVD chemotherapy: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle"
11367048|NCT00901303|BG002|Baseline|Total|Total of all reporting groups
11367049|NCT00901303|FG000|Participant Flow|Early Stage Disease|"Group A~ABVD chemotherapy: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle"
11367050|NCT00901303|FG001|Participant Flow|Advanced Stage Disease|"Group B~ABVD chemotherapy: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle"
11367051|NCT00901303|OG000|Outcome|Group A|"early stage disease~ABVD chemotherapy: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle"
11367052|NCT00901303|OG001|Outcome|Group B|"advanced stage disease~ABVD chemotherapy: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle"
11367053|NCT00901303|EG000|Reported Event|Early Stage Disease|"Group A~ABVD chemotherapy: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle"
11367054|NCT00901303|EG001|Reported Event|Advanced Stage Disease|"Group B~ABVD chemotherapy: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle"
11367055|NCT00906035|BG000|Baseline|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367056|NCT00906035|BG001|Baseline|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367057|NCT00906035|BG002|Baseline|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367058|NCT00906035|BG003|Baseline|Total|Total of all reporting groups
11367059|NCT00906035|FG000|Participant Flow|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11189322|NCT02119260|FG001|Participant Flow|Cohort 2|Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
11367060|NCT00906035|FG001|Participant Flow|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367061|NCT00906035|FG002|Participant Flow|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11189323|NCT02119260|FG002|Participant Flow|Cohort 3|Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
11367062|NCT00906035|OG000|Outcome|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367063|NCT00906035|OG001|Outcome|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367064|NCT00906035|OG002|Outcome|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367065|NCT00906035|EG000|Reported Event|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367066|NCT00906035|EG001|Reported Event|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367067|NCT00906035|EG002|Reported Event|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
11367068|NCT00904423|BG000|Baseline|Vitamin D|
11367069|NCT00904423|FG000|Participant Flow|Vitamin D|
11367070|NCT00904423|OG000|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
11367071|NCT00904423|EG000|Reported Event|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
11367072|NCT00903396|BG000|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
11367073|NCT00903396|BG001|Baseline|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
11367074|NCT00903396|BG002|Baseline|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
11367075|NCT00903396|BG003|Baseline|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
11367076|NCT00903396|BG004|Baseline|Total|Total of all reporting groups
11367077|NCT00903396|FG000|Participant Flow|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
11367078|NCT00903396|FG001|Participant Flow|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
11367079|NCT00903396|FG002|Participant Flow|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
11189324|NCT02119260|FG003|Participant Flow|Cohort 4 (GSK2798745 2.4 mg SD and RD)|Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg . GSK2798745 was administered in capsule formulation
11367080|NCT00903396|FG003|Participant Flow|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
11367081|NCT00903396|OG000|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
11367082|NCT00903396|OG001|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
11367083|NCT00903396|OG002|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
11367084|NCT00903396|OG003|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
11367085|NCT00903396|EG000|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
11367086|NCT00903396|EG001|Reported Event|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
11367087|NCT00903396|EG002|Reported Event|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
11367088|NCT00903396|EG003|Reported Event|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
11189325|NCT02119260|FG004|Participant Flow|Cohort 4 (Placebo RD)|Participants with heart failure received placebo. Placebo was administered in capsule formulation
11367089|NCT00894790|BG000|Baseline|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
11367090|NCT00894790|BG001|Baseline|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
11367091|NCT00894790|BG002|Baseline|Total|Total of all reporting groups
11367092|NCT00894790|FG000|Participant Flow|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
11367093|NCT00894790|FG001|Participant Flow|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
11367094|NCT00894790|OG000|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
11367095|NCT00894790|OG001|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
11367096|NCT00894790|EG000|Reported Event|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
11367097|NCT00894790|EG001|Reported Event|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
11189326|NCT02119260|FG005|Participant Flow|Cohort 5 (GSK2798745 2.4 mg RD)|Participants with heart failure received repeat-doses of GSK2798745 2.4 mg. GSK2798745 was administered in capsule formulation
11367098|NCT00902668|BG000|Baseline|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11367099|NCT00902668|FG000|Participant Flow|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11367100|NCT00902668|OG000|Outcome|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11367101|NCT00902668|EG000|Reported Event|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
11367102|NCT00881205|BG000|Baseline|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
11367103|NCT00881205|BG001|Baseline|Placebo|Matching the size, shape and color of rivastigmine patches.
11367104|NCT00881205|BG002|Baseline|Total|Total of all reporting groups
11367105|NCT00881205|FG000|Participant Flow|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
11367106|NCT00881205|FG001|Participant Flow|Placebo|Matching the size, shape and color of rivastigmine patches.
11367107|NCT00881205|OG000|Outcome|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
11367108|NCT00881205|OG001|Outcome|Placebo|Matching the size, shape and color of rivastigmine patches.
11367109|NCT00881205|EG000|Reported Event|Total Patients|Total Patients
11367110|NCT00881205|EG001|Reported Event|Rivastigmine|Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
11367111|NCT00881205|EG002|Reported Event|Placebo|Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
11367112|NCT00896025|BG000|Baseline|N-acetycylcysteine|Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous NAC infusion for a total of 72 hours.
11367113|NCT00896025|FG000|Participant Flow|N-acetycylcysteine|Acute liver failure population
11367114|NCT00896025|OG000|Outcome|N-acetycylcysteine|"Acute liver failure population~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
11367115|NCT00896025|OG000|Outcome|N-acetycylcysteine|"Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous N-acetylcysteine infusion for a total of 72 hours.~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5"
11367116|NCT00896025|OG001|Outcome|Standard of Care|Each eligible Acute Liver Failure patient for whom the investigator chooses not to utilize N-acetylcysteine may serve as a control and receives standard of care.
11377124|NCT04025632|EG000|Reported Event|Main Portion: Placebo|Participants were randomized to receive daily SC doses of matching placebo during the 8-week Main Portion of the study.
11367117|NCT00896025|EG000|Reported Event|N-acetycylcysteine|"Acute liver failure population~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
11367118|NCT00903006|BG000|Baseline|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
11367119|NCT00903006|BG001|Baseline|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
11367120|NCT00903006|BG002|Baseline|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
11367121|NCT00903006|BG003|Baseline|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
11367122|NCT00903006|BG004|Baseline|Total|Total of all reporting groups
11367123|NCT00903006|FG000|Participant Flow|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
11367124|NCT00903006|FG001|Participant Flow|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
11367125|NCT00903006|FG002|Participant Flow|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
11367126|NCT00903006|FG003|Participant Flow|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
11367127|NCT00903006|OG000|Outcome|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
11367128|NCT00903006|OG001|Outcome|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
11367129|NCT00903006|OG002|Outcome|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
11367130|NCT00903006|OG003|Outcome|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
11367131|NCT00903006|EG000|Reported Event|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
11367132|NCT00903006|EG001|Reported Event|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
10849897|NCT00299130|OG002|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11367133|NCT00903006|EG002|Reported Event|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
11367134|NCT00903006|EG003|Reported Event|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
11367135|NCT00904189|BG000|Baseline|1Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
11367136|NCT00904189|FG000|Participant Flow|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
11367137|NCT00904189|OG000|Outcome|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
11367138|NCT00904189|OG000|Outcome|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
11367139|NCT00904189|EG000|Reported Event|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
11367140|NCT00887315|BG000|Baseline|Chemo Only|Chemotherapy only
11367141|NCT00887315|BG001|Baseline|Chemo and Radiation|Chemotherapy and radiotherapy
11367142|NCT00887315|BG002|Baseline|Total|Total of all reporting groups
11367143|NCT00887315|FG000|Participant Flow|Chemo Only|Chemotherapy only
11189327|NCT02119260|FG006|Participant Flow|Cohort 5 (Placebo RD)|Participants with heart failure received placebo. Placebo was administered in capsule formulation
11367144|NCT00887315|FG001|Participant Flow|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
11367145|NCT00887315|OG000|Outcome|Chemo Only|Chemotherapy only
11367146|NCT00887315|OG001|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
11367147|NCT00887315|EG000|Reported Event|Chemo Only|Chemotherapy only
11367148|NCT00887315|EG001|Reported Event|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
11367149|NCT00891904|BG000|Baseline|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
11367150|NCT00891904|FG000|Participant Flow|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
11367151|NCT00891904|OG000|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
11367152|NCT00891904|EG000|Reported Event|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
11367153|NCT00881608|BG000|Baseline|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
11367154|NCT00881608|BG001|Baseline|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367155|NCT00881608|BG002|Baseline|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367156|NCT00881608|BG003|Baseline|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367157|NCT00881608|BG004|Baseline|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367158|NCT00881608|BG005|Baseline|Total|Total of all reporting groups
11367159|NCT00881608|FG000|Participant Flow|All Subjects Enrolled|All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study.
11367160|NCT00881608|OG000|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
11367161|NCT00881608|OG001|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11377125|NCT04025632|EG001|Reported Event|Main Portion: Zilucoplan 0.3 mg/kg|Participants were randomized to receive daily SC doses of zilucoplan 0.3 mg/kg during the 8-week Main Portion of the study.
11367162|NCT00881608|OG002|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367163|NCT00881608|OG003|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367164|NCT00881608|OG004|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367165|NCT00881608|EG000|Reported Event|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
11367166|NCT00881608|EG001|Reported Event|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367167|NCT00881608|EG002|Reported Event|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367168|NCT00881608|EG003|Reported Event|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367169|NCT00881608|EG004|Reported Event|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
11367170|NCT00889421|BG000|Baseline|Treatment|Patient receiving apremilast.
11367171|NCT00889421|FG000|Participant Flow|Treatment|Patient receiving apremilast.
11189328|NCT02119260|OG000|Outcome|Cohort 1|Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
11367172|NCT00889421|OG000|Outcome|Treatment|Patient receiving apremilast.
11367173|NCT00889421|EG000|Reported Event|Treatment|Patient receiving apremilast.
11367174|NCT00875394|BG000|Baseline|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
11367175|NCT00875394|BG001|Baseline|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
11367176|NCT00875394|BG002|Baseline|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
11367177|NCT00875394|BG003|Baseline|Total|Total of all reporting groups
11367178|NCT00875394|FG000|Participant Flow|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
11367179|NCT00875394|FG001|Participant Flow|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
11367180|NCT00875394|FG002|Participant Flow|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
11367181|NCT00875394|OG000|Outcome|Sitagliptin + Metformin|Patients administered sitagliptin and metformin.
11367182|NCT00875394|OG001|Outcome|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
11367183|NCT00875394|OG002|Outcome|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
11367184|NCT00875394|EG000|Reported Event|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
11367185|NCT00875394|EG001|Reported Event|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
11367186|NCT00875394|EG002|Reported Event|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
11377126|NCT04025632|EG002|Reported Event|Extension Portion: Zilucoplan 0.3 mg/kg|Participants received daily SC doses of zilucoplan 0.3 mg/kg during the Extension Portion of the study.
11377127|NCT03978091|BG000|Baseline|AVYCAZ IV|2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
11189329|NCT02119260|OG001|Outcome|Cohort 2|Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
11189330|NCT02119260|OG002|Outcome|Cohort 3|Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
11189331|NCT02119260|OG000|Outcome|Cohort 4 (GSK2798745 2.4 mg SD and RD)|Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg . GSK2798745 was administered in capsule formulation
11189332|NCT02119260|OG001|Outcome|Cohort 4 (Placebo RD)|Participants with heart failure received placebo. Placebo was administered in capsule formulation
11189333|NCT02119260|OG002|Outcome|Cohort 5 (GSK2798745 2.4 mg RD)|Participants with heart failure received repeat-doses of GSK2798745 2.4 mg. GSK2798745 was administered in capsule formulation
11189334|NCT02119260|OG003|Outcome|Cohort 5 (Placebo RD)|Participants with heart failure received placebo. Placebo was administered in capsule formulation
11189335|NCT02119260|OG000|Outcome|Cohort 4|Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg or placebo in capsule formulation
11189336|NCT02119260|OG001|Outcome|Cohort 5|Participants with heart failure received repeat-doses of GSK2798745 2.4 mg or placebo in capsule formulation
11189337|NCT02119260|OG000|Outcome|Co 1 (GSK2798745 0.25 mg)|Healthy participants received single oral doses of GSK2798745 0.25 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
11189338|NCT02119260|OG001|Outcome|Co 1 (GSK2798745 1 mg)|Healthy participants received single oral doses of GSK2798745 1 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
11189339|NCT02119260|OG002|Outcome|Co 1 (GSK2798745 5 mg)|Healthy participants received single oral doses of GSK2798745 5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
11189340|NCT02119260|OG003|Outcome|Co 1 (GSK2798745 12.5 mg)|Healthy participants received single oral doses of GSK2798745 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
11189341|NCT02119260|OG004|Outcome|Co 2 (GSK2798745 Fasted Suspension)|Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
11189342|NCT02119260|OG005|Outcome|Co 2 (GSK2798745 Fasted Capsule)|Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
11189343|NCT02119260|OG006|Outcome|Co 2 (GSK2798745 Fed Capsule)|Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
11189344|NCT02119260|OG007|Outcome|Co 3 (GSK2798745 Day 1-5mg)|Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
11189345|NCT02119260|OG008|Outcome|Co 3 (GSK2798745 Day 14-5mg)|Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
11189346|NCT02119260|EG000|Reported Event|Cohort 1|Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
11189347|NCT02119260|EG001|Reported Event|Cohort 2|Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
11189348|NCT02119260|EG002|Reported Event|Cohort 3|Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
11189349|NCT02119260|EG003|Reported Event|Cohort 4|Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg or placebo in capsule formulation
11189350|NCT02119260|EG004|Reported Event|Cohort 5|Participants with heart failure received repeat-doses of GSK2798745 2.4 mg or placebo in capsule formulation
11336695|NCT03570554|FG002|Participant Flow|Treatment C-A-B-D|Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by placebo for 4 days. Treatment periods were separated by a washout period of 3 to 7 days.
11336696|NCT03570554|FG003|Participant Flow|Treatment D-B-A-C|Participants received placebo for 4 days; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.
11336697|NCT03570554|OG000|Outcome|Naproxen|Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day.
11336698|NCT03570554|OG001|Outcome|Acetaminophen ER|Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day.
11336699|NCT03570554|OG002|Outcome|Celecoxib|Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day.
11336700|NCT03570554|OG003|Outcome|Placebo|Participants received placebo for 4 days.
11336701|NCT03570554|EG000|Reported Event|Naproxen|Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day
11367187|NCT00882310|BG000|Baseline|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
11367188|NCT00882310|FG000|Participant Flow|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
11367189|NCT00882310|OG000|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
11367190|NCT00882310|EG000|Reported Event|Gemcitabine, Docetaxel, Capecitabine GTX|"GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.~AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated)."
11367191|NCT00880542|BG000|Baseline|Sorafenib + Ifosfamide|
11367192|NCT00880542|FG000|Participant Flow|Sorafenib + Ifosfamide|
11367193|NCT00880542|OG000|Outcome|Sorafenib + Ifosfamide|
11367194|NCT00880542|EG000|Reported Event|Sorafenib + Ifosfamide|
11367195|NCT00879619|BG000|Baseline|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
11367196|NCT00879619|FG000|Participant Flow|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
11367197|NCT00879619|OG000|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
11367198|NCT00879619|EG000|Reported Event|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
11367199|NCT00874939|BG000|Baseline|All Participants|All enrolled participants
11367200|NCT00874939|FG000|Participant Flow|All Participants|All enrolled participants
11367201|NCT00874939|OG000|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
11367202|NCT00874939|OG001|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
11367203|NCT00874939|OG000|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
11367204|NCT00874939|OG001|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
11367205|NCT00874939|EG000|Reported Event|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
11367206|NCT00874939|EG001|Reported Event|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
11367207|NCT00874939|EG002|Reported Event|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
11367208|NCT00874939|EG003|Reported Event|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
11367209|NCT00878605|BG000|Baseline|Placebo|"Placebo control~Placebo: Placebo control"
11367210|NCT00878605|BG001|Baseline|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
11367211|NCT00878605|BG002|Baseline|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
11367212|NCT00878605|BG003|Baseline|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
11367213|NCT00878605|BG004|Baseline|Total|Total of all reporting groups
11367214|NCT00878605|FG000|Participant Flow|Arm 1|"Placebo control~Placebo: Placebo control~Participants received placebo tablet orally daily for 12 weeks."
11367215|NCT00878605|FG001|Participant Flow|Arm 2|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 3mg + 20 mg zinc orally per day for 12 weeks."
11377128|NCT03978091|BG001|Baseline|AVYCAZ CI|2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
11367216|NCT00878605|FG002|Participant Flow|Arm 3|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 9mg + 20 mg zinc orally per day for 12 weeks."
11367217|NCT00878605|FG003|Participant Flow|Arm 4|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 15mg + 20 mg zinc orally per day for 12 weeks."
11367218|NCT00878605|OG000|Outcome|Placebo|"Placebo control~Placebo: Placebo control"
11367219|NCT00878605|OG001|Outcome|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
11367220|NCT00878605|OG002|Outcome|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
11367221|NCT00878605|OG003|Outcome|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
11367222|NCT00878605|EG000|Reported Event|Arm 1|"Placebo control~Placebo: Placebo control"
11367223|NCT00878605|EG001|Reported Event|Arm 2|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
11367224|NCT00878605|EG002|Reported Event|Arm 3|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
10850266|NCT00301067|FG002|Participant Flow|Cohort 3 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11367225|NCT00878605|EG003|Reported Event|Arm 4|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
11367226|NCT00877071|BG000|Baseline|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
11367227|NCT00877071|FG000|Participant Flow|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
11367228|NCT00877071|OG000|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
11367229|NCT00877071|EG000|Reported Event|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
11367230|NCT00878969|BG000|Baseline|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
11367231|NCT00878969|BG001|Baseline|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 6 mg of ramipril taken orally on a daily basis for 18 months
11367232|NCT00878969|BG002|Baseline|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
11367233|NCT00878969|BG003|Baseline|Total|Total of all reporting groups
11367234|NCT00878969|FG000|Participant Flow|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
11367235|NCT00878969|FG001|Participant Flow|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
11367236|NCT00878969|FG002|Participant Flow|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
11367237|NCT00878969|OG000|Outcome|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
11367238|NCT00878969|OG001|Outcome|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
11367239|NCT00878969|OG002|Outcome|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
11367240|NCT00878969|EG000|Reported Event|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
11367241|NCT00878969|EG001|Reported Event|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
11240140|NCT02476565|BG000|Baseline|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
11336702|NCT03570554|EG001|Reported Event|Acetaminophen ER|Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day
11336703|NCT03570554|EG002|Reported Event|Celecoxib|Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day
11336704|NCT03570554|EG003|Reported Event|Placebo|Participants received placebo for 4 days
11336705|NCT03570658|BG000|Baseline|Placebo|Participants in both the MAD and SAD cohorts received placebo matched to RO7049389.
11336706|NCT03570658|BG001|Baseline|RO7049389 - 200 mg|Participants in the SAD cohort received a single 200 mg dose of RO7049389.
11336707|NCT03570658|BG002|Baseline|RO7049389 - 400 mg/200 mg q12h|Participants in the SAD cohort received a single 400 mg dose of RO7049389. Participants in the MAD cohort that formerly received the 400 mg single dose received 200 mg of RO7049389 every 12 hours (q12h) for 14 days.
11336708|NCT03570658|BG003|Baseline|RO7049389 - 600 mg/400 mg q12h|Participants in the SAD cohort only received a single 600 mg dose of RO7049389. Participants in the MAD cohort that formerly received the 600 mg single dose received 400 mg of RO7049389 q12h for 14 days.
11336709|NCT03570658|BG004|Baseline|Total|Total of all reporting groups
11336710|NCT03570658|FG000|Participant Flow|Placebo|Participants in both the MAD and SAD cohorts received placebo matched to RO7049389.
11336711|NCT03570658|FG001|Participant Flow|RO7049389 - 200 mg|Participants in the SAD cohort received a single 200 mg dose of RO7049389.
11336712|NCT03570658|FG002|Participant Flow|RO7049389 - 400 mg/200 mg q12h|Participants in the SAD cohort received a single 400 mg dose of RO7049389. Participants in the MAD cohort that formerly received the 400 mg single dose received 200 mg of RO7049389 every 12 hours (q12h) for 14 days.
11336713|NCT03570658|FG003|Participant Flow|RO7049389 - 600 mg/400 mg q12h|Participants in the SAD cohort only received a single 600 mg dose of RO7049389. Participants in the MAD cohort that formerly received the 600 mg single dose received 400 mg of RO7049389 q12h for 14 days.
11336714|NCT03570658|OG000|Outcome|SAD - Placebo|Participants received placebo matched to RO7049389.
11336715|NCT03570658|OG001|Outcome|SAD RO7049389 - 200 mg|Participants received a single 200 mg dose of RO7049389.
11336716|NCT03570658|OG002|Outcome|SAD RO7049389 - 400 mg|Participants received a single 400 mg dose of RO7049389.
11336717|NCT03570658|OG003|Outcome|SAD RO7049389 - 600 mg|Participants received a single 600 mg dose of RO7049389.
11336718|NCT03570658|OG004|Outcome|MAD - Placebo|Participants received placebo matched to RO7049389.
11336719|NCT03570658|OG005|Outcome|MAD RO7049389 - 200 mg|Participants received 200 mg of RO7049389 every 12 hours for 14 days.
11336720|NCT03570658|OG006|Outcome|MAD RO7049389 - 400 mg|Participants received 400 mg of RO7049389 every 12 hours for 14 days.
11336721|NCT03570658|OG000|Outcome|SAD RO7049389 - 200 mg|Participants received a single 200 mg dose of RO7049389.
11336722|NCT03570658|OG001|Outcome|SAD RO7049389 - 400 mg|Participants received a single 400 mg dose of RO7049389.
11336723|NCT03570658|OG002|Outcome|SAD RO7049389 - 600 mg|Participants received a single 600 mg dose of RO7049389.
11336724|NCT03570658|OG003|Outcome|MAD RO7049389 - 200 mg|Participants received 200 mg of RO7049389 every 12 hours for 14 days.
11336725|NCT03570658|OG004|Outcome|MAD RO7049389 - 400 mg|Participants received 400 mg of RO7049389 every 12 hours for 14 days.
11336726|NCT03570658|OG000|Outcome|MAD RO7049389 - 200 mg|Participants received 200 mg of RO7049389 every 12 hours for 14 days.
11336727|NCT03570658|OG001|Outcome|MAD RO7049389 - 400 mg|Participants received 400 mg of RO7049389 every 12 hours for 14 days.
11336728|NCT03570658|OG001|Outcome|RO7049389 - 400 mg|Participants in the SAD cohort received a single 400 mg dose of RO7049389, followed by a 1-week washout period. Participants in the MAD cohort that formerly received the 600 mg single dose received 400 mg of RO7049389 every 12 hours for 14 days.
11336729|NCT03570658|EG000|Reported Event|SAD - Placebo|Participants received placebo matched to RO7049389.
11336730|NCT03570658|EG001|Reported Event|SAD RO7049389 - 200 mg|Participants received a single 200 mg dose of RO7049389.
11336731|NCT03570658|EG002|Reported Event|SAD RO7049389 - 400 mg|Participants received a single 400 mg dose of RO7049389.
11336732|NCT03570658|EG003|Reported Event|SAD RO7049389 - 600 mg|Participants received a single 600 mg dose of RO7049389.
11336733|NCT03570658|EG004|Reported Event|MAD - Placebo|Participants received placebo matched to RO7049389
11336734|NCT03570658|EG005|Reported Event|MAD RO7049389 - 200 mg|Participants received 200 mg of RO7049389 every 12 hours for 14 days.
11336735|NCT03570658|EG006|Reported Event|MAD RO7049389 - 400 mg|Participants received 400 mg of RO7049389 every 12 hours for 14 days.
11336736|NCT03571256|BG000|Baseline|TEV-50717 High-Dose|TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks
11336737|NCT03571256|BG001|Baseline|TEV-50717 Low-Dose|TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks
11336738|NCT03571256|BG002|Baseline|Placebo|Placebo matched to TEV-50717 for a total of 8 weeks
11336739|NCT03571256|BG003|Baseline|Total|Total of all reporting groups
11336740|NCT03571256|FG000|Participant Flow|TEV-50717 High-Dose|TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 8 weeks
11336741|NCT03571256|FG001|Participant Flow|TEV-50717 Low-Dose|TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks
11336742|NCT03571256|FG002|Participant Flow|Placebo|Placebo matched to TEV-50717 for a total of 8 weeks
11336743|NCT03571256|OG000|Outcome|TEV-50717 High-Dose|TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks
11336744|NCT03571256|OG001|Outcome|Placebo|Placebo matched to TEV-50717 for a total of 8 weeks
11336745|NCT03571256|OG000|Outcome|TEV-50717 Low-Dose|TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks
11336746|NCT03571256|OG001|Outcome|TEV-50717 Low-Dose|TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks
11377129|NCT03978091|BG002|Baseline|ATM IV|2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
11336747|NCT03571256|OG002|Outcome|Placebo|Placebo matched to TEV-50717 for a total of 8 weeks
11336748|NCT03571256|EG000|Reported Event|TEV-50717 High-Dose|TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks
11336749|NCT03571256|EG001|Reported Event|TEV-50717 Low-Dose|TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks
11336750|NCT03571256|EG002|Reported Event|Placebo|Placebo matched to TEV-50717 for a total of 8 weeks
11336751|NCT03571516|BG000|Baseline|Teduglutide (TED)|Participants (infants) 4 to 12 months of corrected gestational aged received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection QD in addition to standard medical therapy for 24 weeks.
11336752|NCT03571516|BG001|Baseline|Standard of Care (SOC)|Participants (infants) 4 to 12 months of corrected gestational aged received standard medical therapy for 24 weeks.
11336753|NCT03571516|BG002|Baseline|Total|Total of all reporting groups
11336754|NCT03571516|FG000|Participant Flow|Teduglutide (TED)|Participants (infants) 4 to 12 months of corrected gestational aged received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection QD in addition to standard medical therapy for 24 weeks.
11336755|NCT03571516|FG001|Participant Flow|Standard of Care (SOC)|Participants (infants) 4 to 12 months of corrected gestational aged received standard medical therapy for 24 weeks.
11336756|NCT03571516|OG000|Outcome|Teduglutide (TED)|Participants (infants) 4 to 12 months of corrected gestational aged received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection QD in addition to standard medical therapy for 24 weeks.
11336757|NCT03571516|OG001|Outcome|Standard of Care (SOC)|Participants (infants) 4 to 12 months of corrected gestational aged received standard medical therapy for 24 weeks.
11336758|NCT03571516|EG000|Reported Event|Teduglutide (TED)|Participants (infants) 4 to 12 months of corrected gestational aged received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection QD in addition to standard medical therapy for 24 weeks.
11336759|NCT03571516|EG001|Reported Event|Standard of Care (SOC)|Participants (infants) 4 to 12 months of corrected gestational aged received standard medical therapy for 24 weeks.
11336760|NCT03571555|BG000|Baseline|Young People With Perinatally Acquired HIV|"Residential interventions (camps) and community based support (clubs)~Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers."
11336761|NCT03571555|BG001|Baseline|Caregivers of Young People With Perinatally Acquired HIV|"Community based support (clubs)~Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers."
11336762|NCT03571555|BG002|Baseline|Total|Total of all reporting groups
11336763|NCT03571555|FG000|Participant Flow|Young People With Perinatally Acquired HIV|"Residential interventions (camps) and community based support (clubs)~Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers."
11336764|NCT03571555|FG001|Participant Flow|Caregivers of Young People With Perinatally Acquired HIV|"Community based support (clubs)~Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers."
11336765|NCT03571555|OG000|Outcome|Young People With Perinatally Acquired HIV|"Residential interventions (camps) and community based support (clubs)~Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers."
11336766|NCT03571555|OG001|Outcome|Caregivers of Young People With Perinatally Acquired HIV|"Community based support (clubs)~Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers."
11336767|NCT03571555|EG000|Reported Event|Young People With Perinatally Acquired HIV|"Residential interventions (camps) and community based support (clubs)~Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers."
11336768|NCT03571555|EG001|Reported Event|Caregivers of Young People With Perinatally Acquired HIV|"Community based support (clubs)~Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers."
11336769|NCT03571607|BG000|Baseline|13vPnC: 6 to <18 Years|Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336770|NCT03571607|BG001|Baseline|13vPnC: 18 to <65 Years|Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336771|NCT03571607|BG002|Baseline|Total|Total of all reporting groups
11336772|NCT03571607|FG000|Participant Flow|13vPnC: 6 to <18 Years|Participants aged between 6 to less than (<) 18 years received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly on Day 1.
11336773|NCT03571607|FG001|Participant Flow|13vPnC: 18 to <65 Years|Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336774|NCT03571607|OG000|Outcome|13vPnC: 6 to <18 Years|Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336775|NCT03571607|OG000|Outcome|13vPnC: 18 to <65 Years|Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336776|NCT03571607|OG000|Outcome|13vPnC: All Participants|All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336777|NCT03571607|EG000|Reported Event|13vPnC: 6 to <18 Years|Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336778|NCT03571607|EG001|Reported Event|13vPnC: 18 to <65 Years|Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336779|NCT03571607|EG002|Reported Event|13vPnC: All Participants|All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
11336780|NCT03571672|BG000|Baseline|Definity|"Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound~DEFINITY: All subjects will receive a single dose of DEFINITY®"
11367242|NCT00878969|EG002|Reported Event|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
11367243|NCT00865514|BG000|Baseline|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
11367244|NCT00865514|FG000|Participant Flow|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
11367245|NCT00865514|OG000|Outcome|The Interaction of DCA and/or Tyrosine Breakdown Products|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
11367246|NCT00865514|OG000|Outcome|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
11367247|NCT00865514|EG000|Reported Event|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
11367248|NCT00869414|BG000|Baseline|All Study Participants|Participants were randomized to receive one of the three interventions: Insulin glargine only in the morning, Insulin glargine only in the evening, or a split dose of insulin glargine (half the dose in the morning and the other half in the evening).
10963954|NCT00875056|OG001|Outcome|Indolent Non-FL B-NHL or MCL|Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
11367249|NCT00869414|FG000|Participant Flow|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine~Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
11367250|NCT00869414|FG001|Participant Flow|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine~Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
11367251|NCT00869414|FG002|Participant Flow|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening~split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
11367252|NCT00869414|OG000|Outcome|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine~Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
11367253|NCT00869414|OG001|Outcome|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine~Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
11367254|NCT00869414|OG002|Outcome|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening~split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
11367255|NCT00869414|EG000|Reported Event|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine~Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
11367256|NCT00869414|EG001|Reported Event|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine~Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
11367257|NCT00869414|EG002|Reported Event|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening~split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
11367258|NCT00863512|BG000|Baseline|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
11367259|NCT00863512|BG001|Baseline|Arm II (Observation)|Patients receive standard care (observation).
11367260|NCT00863512|BG002|Baseline|Total|Total of all reporting groups
11377130|NCT03978091|BG003|Baseline|ATM CI|2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
11367261|NCT00863512|FG000|Participant Flow|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
11367262|NCT00863512|FG001|Participant Flow|Arm II (Observation)|Patients receive standard care (observation).
11367263|NCT00863512|OG000|Outcome|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
11367264|NCT00863512|OG001|Outcome|Arm II (Observation)|Patients receive standard care (observation).
11367265|NCT00863512|EG000|Reported Event|Arm II (Observation)|Patients receive standard care (observation).
11367266|NCT00863512|EG001|Reported Event|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
11367267|NCT00868998|BG000|Baseline|Treatment|Gemcitabine, Docetaxel, and Capecitabine
11367268|NCT00868998|FG000|Participant Flow|Treatment|Gemcitabine, Docetaxel, and Capecitabine
11367269|NCT00868998|OG000|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
11367270|NCT00868998|EG000|Reported Event|Treatment|Gemcitabine, Docetaxel, and Capecitabine
11367271|NCT00869258|BG000|Baseline|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
11367272|NCT00869258|FG000|Participant Flow|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
11367273|NCT00869258|OG000|Outcome|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
11367274|NCT00869258|EG000|Reported Event|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
11367275|NCT00863330|BG000|Baseline|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
11367276|NCT00863330|FG000|Participant Flow|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
11367277|NCT00863330|OG000|Outcome|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
11367278|NCT00863330|EG000|Reported Event|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
11367279|NCT00853229|BG000|Baseline|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367280|NCT00853229|BG001|Baseline|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367281|NCT00853229|BG002|Baseline|Total|Total of all reporting groups
11367282|NCT00853229|FG000|Participant Flow|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367283|NCT00853229|FG001|Participant Flow|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367284|NCT00853229|OG000|Outcome|Pregabalin/Placebo|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367285|NCT00853229|OG001|Outcome|Placebo/Pregabalin|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367286|NCT00853229|OG000|Outcome|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367287|NCT00853229|OG001|Outcome|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367288|NCT00853229|EG000|Reported Event|Pregabalin/Placebo|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367289|NCT00853229|EG001|Reported Event|Placebo/Pregabalin|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
11367290|NCT00860249|BG000|Baseline|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
11367291|NCT00860249|BG001|Baseline|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
11367292|NCT00860249|BG002|Baseline|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
11367293|NCT00860249|BG003|Baseline|Total|Total of all reporting groups
10850267|NCT00301067|FG003|Participant Flow|Expansion - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11336781|NCT03571672|FG000|Participant Flow|Definity|"Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound~DEFINITY: All subjects will receive a single dose of DEFINITY®"
11336782|NCT03571672|OG000|Outcome|Blinded Reader 1|Independent Blinded Reader 1 of 3
11336783|NCT03571672|OG001|Outcome|Blinded Reader 2|Independent Blinded Reader 2 of 3
11336784|NCT03571672|OG002|Outcome|Blinded Reader 3|Independent Blinded Reader 3 of 3
11336785|NCT03571672|EG000|Reported Event|Definity|Each patient will undergo an unenhanced ultrasound examination and a single dose DEFINITY contrast-enhanced ultrasound during the same imaging session
11336786|NCT03571724|BG000|Baseline|Non-Menthol Very Low Nicotine Cigarettes|"Subjects will be switched from their usual brand to smoke Very Low Nicotine king size cigarettes~Non-Menthol Very Low Nicotine Cigarettes: King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco"
11336787|NCT03571724|BG001|Baseline|Menthol Very Low Nicotine Cigarettes|"Subjects will be switched from their usual brand to smoke Very Low Nicotine king size Menthol cigarettes~Menthol Very Low Nicotine Cigarettes: King size menthol cigarettes containing 0.4mg nicotine /g tobacco"
11336788|NCT03571724|BG002|Baseline|Usual Brand Non-Mentholated|Subjects will continue to use their usual brand non-menthol cigarettes
11336789|NCT03571724|BG003|Baseline|Usual Brand Mentholated|Subjects will continue to use their usual brand menthol cigarettes
11336790|NCT03571724|BG004|Baseline|Total|Total of all reporting groups
11336791|NCT03571724|FG000|Participant Flow|Non-Menthol Very Low Nicotine Cigarettes|"Subjects will be switched from their usual brand to smoke Very Low Nicotine king size cigarettes~Non-Menthol Very Low Nicotine Cigarettes: King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco"
11336792|NCT03571724|FG001|Participant Flow|Menthol Very Low Nicotine Cigarettes|"Subjects will be switched from their usual brand to smoke Very Low Nicotine king size Menthol cigarettes~Menthol Very Low Nicotine Cigarettes: King size menthol cigarettes containing 0.4mg nicotine /g tobacco"
11336793|NCT03571724|FG002|Participant Flow|Usual Brand Non-Metholated|Subjects continue to smoke their usual brand non-Menthol cigarettes
11336794|NCT03571724|FG003|Participant Flow|Usual Brand Metholated|Subjects continue to smoke their usual brand Menthol cigarettes
11336795|NCT03571724|OG000|Outcome|Very Low Nicotine Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336796|NCT03571724|OG001|Outcome|Very Low Nicotine Non-Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336797|NCT03571724|OG002|Outcome|Very Low Nicotine Combined|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336798|NCT03571724|OG003|Outcome|Usual Brand Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336799|NCT03571724|OG004|Outcome|Usual Brand Non-Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336800|NCT03571724|OG005|Outcome|Usual Brand Combined|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336801|NCT03571724|OG000|Outcome|VLN Non-Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336802|NCT03571724|OG001|Outcome|VLN Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336803|NCT03571724|OG002|Outcome|VLN Combined|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336804|NCT03571724|OG003|Outcome|UB Non-Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336805|NCT03571724|OG004|Outcome|UB Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11367294|NCT00860249|FG000|Participant Flow|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
11367295|NCT00860249|FG001|Participant Flow|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
11367296|NCT00860249|FG002|Participant Flow|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
11367297|NCT00860249|OG000|Outcome|Usual Care|Usual Care - participants receive usual care
11367298|NCT00860249|OG001|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
11367299|NCT00860249|OG002|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
11367300|NCT00860249|EG000|Reported Event|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
11367301|NCT00860249|EG001|Reported Event|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
11367302|NCT00860249|EG002|Reported Event|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
11367303|NCT00860158|BG000|Baseline|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
11367304|NCT00860158|FG000|Participant Flow|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
11367305|NCT00860158|OG000|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
11367306|NCT00860158|EG000|Reported Event|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
11367307|NCT00853567|BG000|Baseline|25 g Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
11367308|NCT00853567|BG001|Baseline|50 mg Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
11367309|NCT00853567|BG002|Baseline|Placebo|Placebo treatment
11367310|NCT00853567|BG003|Baseline|Total|Total of all reporting groups
11367311|NCT00853567|FG000|Participant Flow|All Arms|Proellex: 25 mg or 50 mg or placebo oral daily dose
11367312|NCT00853567|OG000|Outcome|25 g Proellex|"25 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
11367313|NCT00853567|OG001|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
11367314|NCT00853567|OG002|Outcome|Placebo|"Placebo treatment~placebo: Placebo"
11367315|NCT00853567|EG000|Reported Event|25 g Proellex|"25 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
11367316|NCT00853567|EG001|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
11367317|NCT00853567|EG002|Reported Event|Placebo|"Placebo treatment~placebo: Placebo"
11367318|NCT00849524|BG000|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
11367319|NCT00849524|FG000|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
11367320|NCT00849524|OG000|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
11367321|NCT00849524|EG000|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
11367322|NCT00843986|BG000|Baseline|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
11367323|NCT00843986|BG001|Baseline|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
11367324|NCT00843986|BG002|Baseline|Total|Total of all reporting groups
11367325|NCT00843986|FG000|Participant Flow|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
11367326|NCT00843986|FG001|Participant Flow|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
11367327|NCT00843986|OG000|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
11367328|NCT00843986|OG001|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
11367329|NCT00843986|EG000|Reported Event|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
11367330|NCT00843986|EG001|Reported Event|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
11367331|NCT00851682|BG000|Baseline|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
11367332|NCT00851682|BG001|Baseline|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
11367333|NCT00851682|BG002|Baseline|Total|Total of all reporting groups
11367334|NCT00851682|FG000|Participant Flow|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
11367335|NCT00851682|FG001|Participant Flow|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
11367336|NCT00851682|OG000|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
11367337|NCT00851682|OG001|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
11367338|NCT00851682|EG000|Reported Event|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
11367339|NCT00851682|EG001|Reported Event|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
11367340|NCT00852124|BG000|Baseline|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
11367341|NCT00852124|BG001|Baseline|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
11367342|NCT00852124|BG002|Baseline|Total|Total of all reporting groups
11367343|NCT00852124|FG000|Participant Flow|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
11367344|NCT00852124|FG001|Participant Flow|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
11367345|NCT00852124|OG000|Outcome|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
11367346|NCT00852124|EG000|Reported Event|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
11367347|NCT00852124|EG001|Reported Event|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
11367348|NCT00850421|BG000|Baseline|Botulinum Toxin Type A|
11367349|NCT00850421|FG000|Participant Flow|Botulinum Toxin Type A|
11367350|NCT00850421|OG000|Outcome|Botulinum Toxin Type A|
11367351|NCT00850421|OG000|Outcome|Botulinum Toxin Type A|Botulinum Toxin Type A: 100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
11367352|NCT00850421|EG000|Reported Event|Botulinum Toxin Type A|
11367353|NCT00851747|BG000|Baseline|C Phosphatidylcholine Deoxycholate|Phosphatidylcholine Deoxycholate Injections
11367354|NCT00851747|BG001|Baseline|A Saline|Group A will serve as a control and will receive only injections of saline as a placebo.
11367355|NCT00851747|BG002|Baseline|B PhosphatidylcholineDeoxycholate/Saline|Group B will receive saline injections on one side of the body and receive PhosphatidylcholineDeoxycholate injections on the contralateral side.
11367356|NCT00851747|BG003|Baseline|Total|Total of all reporting groups
11367357|NCT00851747|FG000|Participant Flow|A Saline|Group A will serve as a control and will receive only injections of saline as a placebo.
11367358|NCT00851747|FG001|Participant Flow|B PhosphatidylcholineDeoxycholate/Saliine|Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side
11367359|NCT00851747|FG002|Participant Flow|C Phosphatidylcholine Deoxycholate|"Phosphatidylcholine Deoxycholate Injections~Group C will receive only study drug injections"
11367360|NCT00851747|OG000|Outcome|Subcutaneous Injections|"Phosphatidylcholine Deoxycholate Injections~Phosphatidylcholine Deoxycholate: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections~Saline: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections"
11367361|NCT00851747|OG001|Outcome|Saline|"Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections~Saline: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections"
11367362|NCT00851747|EG000|Reported Event|C Phosphatidylcholine Deoxycholate|Group C will receive only Phosphatidylcholine Deoxycholate injections
11367363|NCT00851747|EG001|Reported Event|A Saline|Group A will serve as a control and will receive only injections of saline as a placebo.
11367364|NCT00851747|EG002|Reported Event|B PhosphatidylcholineDeoxycholate/Saline|Group B will receive saline injections on one side of the body and receive PhosphatidylcholineDeoxycholate injections on the contralateral side.
11367365|NCT00852241|BG000|Baseline|Restalyne and Perlane|"One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Restalyne: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Perlane: One syringe of Perlane® (1.0cc) will be used total for both tear trough areas."
11367366|NCT00852241|FG000|Participant Flow|Restalyne and Perlane|"One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Restalyne and Perlane: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas."
11367367|NCT00852241|OG000|Outcome|Restalyne and Perlane|"One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Restalyne and Perlane: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas."
11367368|NCT00852241|EG000|Reported Event|Restalyne and Perlane|"One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Restalyne and Perlane: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas."
11367369|NCT00851552|BG000|Baseline|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
11367370|NCT00851552|FG000|Participant Flow|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
11367371|NCT00851552|OG000|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
11367372|NCT00851552|EG000|Reported Event|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
11367373|NCT00850720|BG000|Baseline|Cardiac Surgery|Infants with congenital defects.
11367374|NCT00850720|FG000|Participant Flow|Cardiac Surgery|Infants with congenital defects.
11367375|NCT00850720|OG000|Outcome|Cardiac Surgery|Infants with congenital defects.
11367376|NCT00850720|EG000|Reported Event|Cardiac Surgery|Infants with congenital defects.
11367377|NCT00845845|BG000|Baseline|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
11367378|NCT00845845|BG001|Baseline|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
11367379|NCT00845845|BG002|Baseline|Total|Total of all reporting groups
11367380|NCT00845845|FG000|Participant Flow|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
11367381|NCT00845845|FG001|Participant Flow|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
11367382|NCT00845845|OG000|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
11367383|NCT00845845|OG001|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
11367384|NCT00845845|EG000|Reported Event|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
11367385|NCT00845845|EG001|Reported Event|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
11367386|NCT00851591|BG000|Baseline|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
11367387|NCT00851591|BG001|Baseline|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
11367388|NCT00851591|BG002|Baseline|Total|Total of all reporting groups
11367389|NCT00851591|FG000|Participant Flow|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
11367390|NCT00851591|FG001|Participant Flow|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
11367391|NCT00851591|OG000|Outcome|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
11367392|NCT00851591|OG000|Outcome|Milk Fat and Milk Protein|"Milk fat levels were not determined in these samples as we had already decided to close study.~Milk Protein levels were not determined in these samples as we had already decided to close study."
11367393|NCT00851591|EG000|Reported Event|1 Group Scheduled to Receive Fenugreek|Fenugreek Category: These patients were scheduled to take 3 capsules 3 times per day with a full glass of water and each dose was for 7 days.
11367394|NCT00851591|EG001|Reported Event|2 Group Scheduled to Receive Placebo|Psyllium Category: These patients were scheduled to take 3 capsules 3 times a day with a full glass of water and each dose was for 7 days.
11367395|NCT00847509|BG000|Baseline|[F-18]FLT Scan|
11367396|NCT00847509|FG000|Participant Flow|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
11367397|NCT00847509|OG000|Outcome|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
11367398|NCT00847509|EG000|Reported Event|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
11367399|NCT00843310|BG000|Baseline|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
11367400|NCT00843310|FG000|Participant Flow|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
11367401|NCT00843310|OG000|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
11367402|NCT00843310|EG000|Reported Event|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
11367403|NCT00847002|BG000|Baseline|Standard of Care Wound Treatment|Standard Wound Care using compression
11367404|NCT00847002|BG001|Baseline|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
11367405|NCT00847002|BG002|Baseline|Total|Total of all reporting groups
11367406|NCT00847002|FG000|Participant Flow|Standard of Care|Standard Wound Care using compression
11367407|NCT00847002|FG001|Participant Flow|Flexitouch System|Flexitouch system with Standard Wound Care using compression
11367408|NCT00847002|OG000|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
11367409|NCT00847002|OG001|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
11367410|NCT00847002|EG000|Reported Event|Standard of Care Wound Treatment|Standard Wound Care using compression
11367411|NCT00847002|EG001|Reported Event|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
11367412|NCT00845702|BG000|Baseline|TOF and Dotarem Enhanced MRA|Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg).
11367413|NCT00845702|FG000|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg).
11367414|NCT00845702|OG000|Outcome|Dotarem MRA|Each subject will receive one injection of Dotarem 0.2 ml/kg.
11367415|NCT00845702|OG001|Outcome|Time Of Flight MRA|Each subject will undergo a TOF MRA
11367416|NCT00845702|EG000|Reported Event|Dotarem Magnetic Resonance Angiography|Each subject will receive one injection of Dotarem 0.2 ml/kg.
11367417|NCT00845702|EG001|Reported Event|Time Of Flight MRA|Subjects undergo a TOF MRA
11367418|NCT00843830|BG000|Baseline|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
11367419|NCT00843830|FG000|Participant Flow|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
11367420|NCT00843830|OG000|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
11367421|NCT00843830|EG000|Reported Event|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
11367422|NCT00835679|BG000|Baseline|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
11367423|NCT00835679|BG001|Baseline|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
11367424|NCT00835679|BG002|Baseline|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
11367425|NCT00835679|BG003|Baseline|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
11367426|NCT00835679|BG004|Baseline|Total|Total of all reporting groups
11367427|NCT00835679|FG000|Participant Flow|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
11367428|NCT00835679|FG001|Participant Flow|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
11367429|NCT00835679|FG002|Participant Flow|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
11367430|NCT00835679|FG003|Participant Flow|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
11377131|NCT03978091|BG004|Baseline|AVYCAZ + ATM 1.5|2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
11336806|NCT03571724|OG005|Outcome|UB Combined|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336807|NCT03571724|OG002|Outcome|UB Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336808|NCT03571724|OG002|Outcome|UB Non-Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336809|NCT03571724|OG003|Outcome|UB Mentholated|Subjects were randomized to one of four study product groups, with menthol cigarette smokers randomized to either their usual brand menthol cigarettes or VLN mentholated cigarettes, and non-menthol cigarette smokers randomized to their usual brand non-menthol cigarettes or VLN non-mentholated cigarettes.
11336810|NCT03571724|EG000|Reported Event|Non-Menthol Very Low Nicotine Cigarettes|"Subjects will be switched from their usual brand to smoke Very Low Nicotine king size cigarettes~Non-Menthol Very Low Nicotine Cigarettes: King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco"
11336811|NCT03571724|EG001|Reported Event|Menthol Very Low Nicotine Cigarettes|"Subjects will be switched from their usual brand to smoke Very Low Nicotine king size Menthol cigarettes~Menthol Very Low Nicotine Cigarettes: King size menthol cigarettes containing 0.4mg nicotine /g tobacco"
11336812|NCT03571724|EG002|Reported Event|Usual Brand Non-Metholated|"Subjects will be switched from their usual brand to smoke Very Low Nicotine king size non-Menthol cigarettes~Non-Menthol Very Low Nicotine Cigarettes: King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco"
11336813|NCT03571724|EG003|Reported Event|Usual Brand Metholated|"Subjects will be switched from their usual brand to smoke Very Low Nicotine king size cigarettes~Menthol Very Low Nicotine Cigarettes: King size menthol cigarettes containing 0.4mg nicotine /g tobacco"
11336814|NCT03572062|BG000|Baseline|Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al[OH]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336815|NCT03572062|BG001|Baseline|Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336816|NCT03572062|BG002|Baseline|Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336817|NCT03572062|BG003|Baseline|Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336818|NCT03572062|BG004|Baseline|Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336819|NCT03572062|BG005|Baseline|Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336820|NCT03572062|BG006|Baseline|Primary Cohort: RSVpreF 240 mcg + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336821|NCT03572062|BG007|Baseline|Primary Cohort: Placebo + SIIV|Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336822|NCT03572062|BG008|Baseline|Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3|Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
11336823|NCT03572062|BG009|Baseline|Month-0, Month-2 Cohort: Placebo|Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
11336824|NCT03572062|BG010|Baseline|Total|Total of all reporting groups
11336825|NCT03572062|FG000|Participant Flow|Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al[OH]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336826|NCT03572062|FG001|Participant Flow|Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336827|NCT03572062|FG002|Participant Flow|Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336828|NCT03572062|FG003|Participant Flow|Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11240141|NCT02476565|BG001|Baseline|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
11240142|NCT02476565|BG002|Baseline|Total|Total of all reporting groups
11336829|NCT03572062|FG004|Participant Flow|Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336830|NCT03572062|FG005|Participant Flow|Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336831|NCT03572062|FG006|Participant Flow|Primary Cohort: RSVpreF 240 mcg + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336832|NCT03572062|FG007|Participant Flow|Primary Cohort: Placebo + SIIV|Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336833|NCT03572062|FG008|Participant Flow|Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3|Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
11336834|NCT03572062|FG009|Participant Flow|Month-0, Month-2 Cohort: Placebo|Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
11336835|NCT03572062|OG000|Outcome|Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al[OH]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336836|NCT03572062|OG001|Outcome|Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336837|NCT03572062|OG002|Outcome|Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336838|NCT03572062|OG003|Outcome|Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336839|NCT03572062|OG004|Outcome|Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336840|NCT03572062|OG005|Outcome|Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336841|NCT03572062|OG006|Outcome|Primary Cohort: RSVpreF 240 mcg + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336842|NCT03572062|OG007|Outcome|Primary Cohort: Placebo + SIIV|Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336843|NCT03572062|EG000|Reported Event|Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al[OH]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336844|NCT03572062|EG001|Reported Event|Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336845|NCT03572062|EG002|Reported Event|Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336846|NCT03572062|EG003|Reported Event|Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336847|NCT03572062|EG004|Reported Event|Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336848|NCT03572062|EG005|Reported Event|Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11367431|NCT00835679|OG000|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
11367432|NCT00835679|OG001|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
11367433|NCT00835679|OG002|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
11367434|NCT00835679|OG003|Outcome|Cetuximab +Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
11367435|NCT00835679|OG003|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
11367436|NCT00835679|OG000|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
11367437|NCT00835679|OG002|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15 1-14.
11367438|NCT00835679|OG003|Outcome|Cetuximab + Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
11367439|NCT00835679|EG000|Reported Event|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
11367440|NCT00835679|EG001|Reported Event|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
11367441|NCT00835679|EG002|Reported Event|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
11367442|NCT00835679|EG003|Reported Event|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
11367443|NCT00841035|BG000|Baseline|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
11367444|NCT00841035|FG000|Participant Flow|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
11367445|NCT00841035|OG000|Outcome|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
11367446|NCT00841035|OG000|Outcome|Eroltinib Added to Standard of Care|150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
11240143|NCT02476565|FG000|Participant Flow|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
11367447|NCT00841035|EG000|Reported Event|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
11367448|NCT00832520|BG000|Baseline|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
11367449|NCT00832520|FG000|Participant Flow|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
11367450|NCT00832520|OG000|Outcome|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
11367451|NCT00832520|EG000|Reported Event|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
11367452|NCT00833859|BG000|Baseline|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
11367453|NCT00833859|FG000|Participant Flow|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
11367454|NCT00833859|OG000|Outcome|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
11367455|NCT00833859|EG000|Reported Event|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
11367456|NCT00843050|BG000|Baseline|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
11367457|NCT00843050|FG000|Participant Flow|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
11367458|NCT00843050|OG000|Outcome|P276-00|P276-00: All patients received P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there was progression of disease or unacceptable toxicity
11367459|NCT00843050|OG000|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
11367460|NCT00843050|EG000|Reported Event|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
11367461|NCT00840827|BG000|Baseline|All Patients|"Lenalidomide 10mg po daily/ CSA 250mg orally twice daily~lenalidomide: Lenalidomide 10mg po daily~cyclosporine A: CSA 250mg orally twice daily"
11367462|NCT00840827|FG000|Participant Flow|All Patients|"Lenalidomide 10mg po daily/ CSA 250mg orally twice daily~lenalidomide: Lenalidomide 10mg po daily~cyclosporine A: CSA 250mg orally twice daily"
11367463|NCT00840827|OG000|Outcome|All Patients|"Lenalidomide 10mg po daily/ CSA 250mg orally twice daily~lenalidomide: Lenalidomide 10mg po daily~cyclosporine A: CSA 250mg orally twice daily"
11367464|NCT00840827|EG000|Reported Event|All Patients|"Lenalidomide 10mg po daily/ CSA 250mg orally twice daily~lenalidomide: Lenalidomide 10mg po daily~cyclosporine A: CSA 250mg orally twice daily"
11367465|NCT00835328|BG000|Baseline|Exendin (9-39) 0.02 mg/kg/hr|Cohort 1: Participants will be administered 0.02 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11336849|NCT03572062|EG006|Reported Event|Primary Cohort: RSVpreF 240 mcg + SIIV|Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336850|NCT03572062|EG007|Reported Event|Primary Cohort: Placebo + SIIV|Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
11336851|NCT03572062|EG008|Reported Event|Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3|Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
11336852|NCT03572062|EG009|Reported Event|Month-0, Month-2 Cohort: Placebo|Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
11336853|NCT03572218|BG000|Baseline|BWL + BIAS|In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
11336854|NCT03572218|BG001|Baseline|Standard BWL|In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
11336855|NCT03572218|BG002|Baseline|Total|Total of all reporting groups
11336856|NCT03572218|FG000|Participant Flow|BWL + BIAS|In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
11336857|NCT03572218|FG001|Participant Flow|Standard BWL|In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
11336858|NCT03572218|OG000|Outcome|BWL + BIAS|In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
11336859|NCT03572218|OG001|Outcome|Standard BWL|In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
11336860|NCT03572218|EG000|Reported Event|BWL + BIAS|In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
11336861|NCT03572218|EG001|Reported Event|Standard BWL|In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
11336862|NCT03572478|BG000|Baseline|Combination Therapy (Phase 1 Cohort)|"Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.~Participants will receive rucaparib plus nivolumab in 4 week cycles.~Rucaparib: 600 mg taken by mouth twice daily.~Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks."
11336863|NCT03572478|FG000|Participant Flow|Combination Therapy (Phase 1 Cohort)|"Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.~Participants will receive rucaparib plus nivolumab in 4 week cycles.~Rucaparib: 600 mg taken by mouth twice daily.~Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks."
11336864|NCT03572478|OG000|Outcome|Combination Therapy (Phase 1 Cohort)|"Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.~Participants will receive rucaparib plus nivolumab in 4 week cycles.~Rucaparib: 600 mg taken by mouth twice daily.~Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks."
11336865|NCT03572478|EG000|Reported Event|Combination Therapy (Phase 1 Cohort)|"Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.~Participants will receive rucaparib plus nivolumab in 4 week cycles.~Rucaparib: 600 mg taken by mouth twice daily.~Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks."
11336866|NCT03572972|BG000|Baseline|NOAC - Apixaban|Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for apixaban was defined as the first prescription date of apixaban during the intake period from 1-July-2015 to 30-November-2016.
11336867|NCT03572972|BG001|Baseline|NOAC - Dabigatran|OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for dabigatran was defined as the first prescription date of dabigatran during the intake period from 1-July-2015 to 30-November-2016.
11336868|NCT03572972|BG002|Baseline|NOAC - Rivaroxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for rivaroxaban was defined as the first prescription date of rivaroxaban during the intake period from 1-July-2015 to 30-November-2016.
11367466|NCT00835328|BG001|Baseline|Exendin (9-39) 0.04 mg/kg/hr|Cohort 2: Participants will be administered 0.04 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367467|NCT00835328|BG002|Baseline|Exendin (9-39) 0.10 mg/kg/hr|Cohort 3: Participants will be administered 0.10 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 6 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367468|NCT00835328|BG003|Baseline|Exendin (9-39) 0.20 mg/kg/hr|Cohort 4: Participants will be administered 0.20 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367469|NCT00835328|BG004|Baseline|Total|Total of all reporting groups
11367470|NCT00835328|FG000|Participant Flow|Exendin (9-39) 0.02 mg/kg/hr|Cohort 1: Participants will be administered 0.02 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first). Glucose infusion rates (GIR) will be titrated three hours prior to infusions to keep blood glucose in the range of 70-90 mg/dL. During both infusions, blood glucose will be measured every 30 minutes.
11367471|NCT00835328|FG001|Participant Flow|Exendin (9-39) 0.04 mg/kg/hr|Cohort 2: Participants will be administered 0.04 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first). Glucose infusion rates (GIR) will be titrated three hours prior to infusions to keep blood glucose in the range of 70-90 mg/dL. During both infusions, blood glucose will be measured every 30 minutes.
11367472|NCT00835328|FG002|Participant Flow|Exendin (9-39) 0.10 mg/kg/hr|Cohort 3: Participants will be administered 0.10 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 6 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first). Glucose infusion rates (GIR) will be titrated three hours prior to infusions to keep blood glucose in the range of 70-90 mg/dL. During both infusions, blood glucose will be measured every 30 minutes.
11367473|NCT00835328|FG003|Participant Flow|Exendin (9-39) 0.20 mg/kg/hr|Cohort 4: Participants will be administered 0.20 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first). Glucose infusion rates (GIR) will be titrated three hours prior to infusions to keep blood glucose in the range of 70-90 mg/dL. During both infusions, blood glucose will be measured every 30 minutes.
11367474|NCT00835328|OG000|Outcome|Exendin (9-39) 0.02 mg/kg/hr|Cohort 1: Participants will be administered 0.02 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367475|NCT00835328|OG001|Outcome|Exendin (9-39) 0.04 mg/kg/hr|Cohort 2: Participants will be administered 0.04 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367476|NCT00835328|OG002|Outcome|Exendin (9-39) 0.10 mg/kg/hr|Cohort 3: Participants will be administered 0.10 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 6 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367477|NCT00835328|OG003|Outcome|Exendin (9-39) 0.20 mg/kg/hr|Cohort 4: Participants will be administered 0.20 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367478|NCT00835328|OG004|Outcome|Vehicle|All participants will be administered normal saline vehicle, via continuous intravenous infusion, over up to 9 hours. Subjects served as their own control for comparison between the effects of Exendin (9-39) and the normal saline vehicle.
11367479|NCT00835328|EG000|Reported Event|Exendin (9-39) 0.02 mg/kg/hr|Cohort 1: Participants will be administered 0.02 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367480|NCT00835328|EG001|Reported Event|Exendin (9-39) 0.04 mg/kg/hr|Cohort 2: Participants will be administered 0.04 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367481|NCT00835328|EG002|Reported Event|Exendin (9-39) 0.10 mg/kg/hr|Cohort 3: Participants will be administered 0.10 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 6 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367482|NCT00835328|EG003|Reported Event|Exendin (9-39) 0.20 mg/kg/hr|Cohort 4: Participants will be administered 0.20 mg/kg/hr of Exendin (9-39) and vehicle (normal saline), via continuous intravenous infusion, over 9 hours on two separate days in random order, with 3 hours of follow-up after the last dose is administered or until blood glucose is < 70 mg/dL (whichever comes first).
11367483|NCT00835328|EG004|Reported Event|Vehicle|All participants will be administered normal saline vehicle via continuous intravenous infusion.
11367484|NCT00832572|BG000|Baseline|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
11367485|NCT00832572|BG001|Baseline|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
11367486|NCT00832572|BG002|Baseline|Total|Total of all reporting groups
11367487|NCT00832572|FG000|Participant Flow|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
11367488|NCT00832572|FG001|Participant Flow|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
11367489|NCT00832572|OG000|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
11367490|NCT00832572|OG001|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
11367491|NCT00832572|EG000|Reported Event|Placebo/Ranolazine, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving placebo).~Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
11367492|NCT00832572|EG001|Reported Event|Placebo/Ranolazine, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving ranolazine).~Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
11367493|NCT00832572|EG002|Reported Event|Ranolazine/Placebo, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving ranolazine).~Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
11367494|NCT00832572|EG003|Reported Event|Ranolazine/Placebo, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving placebo).~Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
11367495|NCT00832624|BG000|Baseline|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
11367496|NCT00832624|FG000|Participant Flow|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
11367497|NCT00832624|OG000|Outcome|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
11367498|NCT00832624|EG000|Reported Event|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
11367499|NCT00832299|BG000|Baseline|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
11367500|NCT00832299|FG000|Participant Flow|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
11367501|NCT00832299|OG000|Outcome|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
11367502|NCT00832299|EG000|Reported Event|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
11367503|NCT00836355|BG000|Baseline|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
11367504|NCT00836355|BG001|Baseline|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
11367505|NCT00836355|BG002|Baseline|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
11367506|NCT00836355|BG003|Baseline|Control|
11367507|NCT00836355|BG004|Baseline|Total|Total of all reporting groups
11367508|NCT00836355|FG000|Participant Flow|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
11367509|NCT00836355|FG001|Participant Flow|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
11367510|NCT00836355|FG002|Participant Flow|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
11367511|NCT00836355|FG003|Participant Flow|Control|
11367512|NCT00836355|OG000|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
11367513|NCT00836355|OG001|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
11367514|NCT00836355|OG002|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
11367515|NCT00836355|OG003|Outcome|Control|
11367516|NCT00836355|EG000|Reported Event|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
11367517|NCT00836355|EG001|Reported Event|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
11367518|NCT00836355|EG002|Reported Event|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
11367519|NCT00836355|EG003|Reported Event|Control|
11367520|NCT00832598|BG000|Baseline|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
11367521|NCT00832598|FG000|Participant Flow|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
11367522|NCT00832598|OG000|Outcome|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
11367523|NCT00832598|EG000|Reported Event|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
11367524|NCT00816777|BG000|Baseline|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
11367525|NCT00816777|BG001|Baseline|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
11367526|NCT00816777|BG002|Baseline|Total|Total of all reporting groups
11189351|NCT02119286|BG000|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11189352|NCT02119286|BG001|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11189353|NCT02119286|BG002|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11367527|NCT00816777|FG000|Participant Flow|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
11367528|NCT00816777|FG001|Participant Flow|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
11367529|NCT00816777|OG000|Outcome|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
11367530|NCT00816777|OG001|Outcome|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
11367531|NCT00816777|EG000|Reported Event|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
11367532|NCT00816777|EG001|Reported Event|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
11367533|NCT00823095|BG000|Baseline|Group 1|Treatment
11367534|NCT00823095|FG000|Participant Flow|Topically Applied Nitric Oxide|Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
11367535|NCT00823095|OG000|Outcome|Group 1|Treatment
11367536|NCT00823095|OG000|Outcome|Treatment|reduction in bioburden as assessed by number of cfu's per cm2 on culture
11367537|NCT00823095|EG000|Reported Event|Group 1|Treatment
11367538|NCT00827567|BG000|Baseline|RAD 001|RAD001-10 mg by mouth once everyday
11367539|NCT00827567|FG000|Participant Flow|RAD 001|RAD001-10 mg by mouth once everyday
11367540|NCT00827567|OG000|Outcome|RAD 001|RAD001-10 mg by mouth once everyday
11189354|NCT02119286|BG003|Baseline|Total|Total of all reporting groups
11189355|NCT02119286|FG000|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11189356|NCT02119286|FG001|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11367541|NCT00827567|EG000|Reported Event|RAD 001|RAD001-10 mg by mouth once everyday
11367542|NCT00815633|BG000|Baseline|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
11367543|NCT00815633|FG000|Participant Flow|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
11367544|NCT00815633|OG000|Outcome|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
11367545|NCT00815633|EG000|Reported Event|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
11367546|NCT00814983|BG000|Baseline|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
11367547|NCT00814983|BG001|Baseline|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
11367548|NCT00814983|BG002|Baseline|Total|Total of all reporting groups
11367549|NCT00814983|FG000|Participant Flow|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
11367550|NCT00814983|FG001|Participant Flow|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
11367551|NCT00814983|OG000|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
11367552|NCT00814983|OG001|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
11367553|NCT00814983|EG000|Reported Event|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
11367554|NCT00814983|EG001|Reported Event|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
11367555|NCT00825227|BG000|Baseline|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
11367556|NCT00825227|BG001|Baseline|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
11367557|NCT00825227|BG002|Baseline|Total|Total of all reporting groups
11367558|NCT00825227|FG000|Participant Flow|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
11367559|NCT00825227|FG001|Participant Flow|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
11367560|NCT00825227|OG000|Outcome|Placebo|"Placebo (3 tablets matching armodafinil tablets)~taxane chemotherapy treatment alone or in combination with other agents"
11367561|NCT00825227|OG001|Outcome|Armodafinil 150 mg/Day|"150 mg/day armodafinil (3 tablets of 50 mg armodafinil)~taxane chemotherapy treatment alone or in combination with other agents"
11367562|NCT00825227|OG000|Outcome|Patient Responses to 150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents~Armodafinil 150 mg/day: - 150 mg/day armodafinil~concurrent with one cycle of taxane chemotherapy alone or in combination with other agents~patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents"
11367563|NCT00825227|OG001|Outcome|Patient Responses to Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents~Placebo,: - placebo~concurrent with one cycle of taxane chemotherapy alone or in combination with other agents~patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents"
11367564|NCT00825227|EG000|Reported Event|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
11367565|NCT00825227|EG001|Reported Event|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
11367566|NCT00819832|BG000|Baseline|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
11367567|NCT00819832|BG001|Baseline|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
11367568|NCT00819832|BG002|Baseline|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
11367569|NCT00819832|BG003|Baseline|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
11367570|NCT00819832|BG004|Baseline|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
11367571|NCT00819832|BG005|Baseline|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
11367572|NCT00819832|BG006|Baseline|Total|Total of all reporting groups
11367573|NCT00819832|FG000|Participant Flow|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
11367574|NCT00819832|FG001|Participant Flow|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
11367575|NCT00819832|FG002|Participant Flow|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
11367576|NCT00819832|FG003|Participant Flow|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
11367577|NCT00819832|FG004|Participant Flow|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
11367578|NCT00819832|FG005|Participant Flow|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
11367579|NCT00819832|OG000|Outcome|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
11367580|NCT00819832|OG001|Outcome|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
11367581|NCT00819832|OG002|Outcome|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
11367582|NCT00819832|OG003|Outcome|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
11367583|NCT00819832|OG004|Outcome|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
11367584|NCT00819832|OG005|Outcome|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
11367585|NCT00819832|EG000|Reported Event|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
11367586|NCT00819832|EG001|Reported Event|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
11367587|NCT00819832|EG002|Reported Event|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
11367588|NCT00819832|EG003|Reported Event|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
11367589|NCT00819832|EG004|Reported Event|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
11367590|NCT00819832|EG005|Reported Event|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
11367591|NCT00822679|BG000|Baseline|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
11367592|NCT00822679|BG001|Baseline|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
11367593|NCT00822679|BG002|Baseline|Total|Total of all reporting groups
11367594|NCT00822679|FG000|Participant Flow|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
11367595|NCT00822679|FG001|Participant Flow|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
11367596|NCT00822679|OG000|Outcome|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
11367597|NCT00822679|OG001|Outcome|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
11367598|NCT00822679|EG000|Reported Event|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
11367599|NCT00822679|EG001|Reported Event|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
11367600|NCT00814892|BG000|Baseline|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
11367601|NCT00814892|FG000|Participant Flow|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
11367602|NCT00814892|OG000|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
11367603|NCT00814892|EG000|Reported Event|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
11367604|NCT00809458|BG000|Baseline|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
11367605|NCT00809458|BG001|Baseline|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
11367606|NCT00809458|BG002|Baseline|Total|Total of all reporting groups
11367607|NCT00809458|FG000|Participant Flow|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
11367608|NCT00809458|FG001|Participant Flow|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
11367609|NCT00809458|OG000|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
11367610|NCT00809458|OG001|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
11367611|NCT00809458|EG000|Reported Event|Arm 1 (Vitamin E)|"Vitamin E~Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
11367612|NCT00809458|EG001|Reported Event|Arm 2|"Placebo (same vehicle as used for vitamin E)~Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
11367613|NCT00802659|BG000|Baseline|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367614|NCT00802659|BG001|Baseline|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11377132|NCT03978091|BG005|Baseline|AVYCAZ + ATM 2.0|2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
11367615|NCT00802659|BG002|Baseline|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11189357|NCT02119286|FG002|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11189358|NCT02119286|OG000|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11367616|NCT00802659|BG003|Baseline|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367617|NCT00802659|BG004|Baseline|Total|Total of all reporting groups
11367618|NCT00802659|FG000|Participant Flow|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367619|NCT00802659|FG001|Participant Flow|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367620|NCT00802659|FG002|Participant Flow|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367621|NCT00802659|FG003|Participant Flow|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367622|NCT00802659|OG000|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367623|NCT00802659|OG001|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367624|NCT00802659|OG002|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367625|NCT00802659|OG003|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367626|NCT00802659|EG000|Reported Event|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367627|NCT00802659|EG001|Reported Event|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367628|NCT00802659|EG002|Reported Event|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11367629|NCT00802659|EG003|Reported Event|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
11189359|NCT02119286|OG001|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11189360|NCT02119286|OG002|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
10962743|NCT00868296|BG001|Baseline|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
10962744|NCT00868296|BG002|Baseline|Total|Total of all reporting groups
10962745|NCT00868296|FG000|Participant Flow|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
11367630|NCT00807365|BG000|Baseline|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
11367631|NCT00807365|FG000|Participant Flow|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, & 5:00 AM for 6 months."
11367632|NCT00807365|OG000|Outcome|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
11367633|NCT00807365|EG000|Reported Event|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
11367634|NCT00814333|BG000|Baseline|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
11367635|NCT00814333|BG001|Baseline|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
11367636|NCT00814333|BG002|Baseline|Total|Total of all reporting groups
11367637|NCT00814333|FG000|Participant Flow|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
11367638|NCT00814333|FG001|Participant Flow|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
11367639|NCT00814333|OG000|Outcome|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
11367640|NCT00814333|OG001|Outcome|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
11367641|NCT00814333|EG000|Reported Event|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
11367642|NCT00814333|EG001|Reported Event|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
11367643|NCT00808080|BG000|Baseline|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)"
11367644|NCT00808080|FG000|Participant Flow|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
11367645|NCT00808080|OG000|Outcome|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
11367646|NCT00808080|OG000|Outcome|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion. NO CTL infusions were administered to any subject, therefore NO outcome measure results are available."
11367647|NCT00808080|EG000|Reported Event|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
11367648|NCT00802893|BG000|Baseline|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
11367649|NCT00802893|FG000|Participant Flow|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
11367650|NCT00802893|OG000|Outcome|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
10962746|NCT00868296|FG001|Participant Flow|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
10962747|NCT00868296|OG000|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
11367651|NCT00802893|EG000|Reported Event|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
11367652|NCT00809341|BG000|Baseline|PET Negative|Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
11367653|NCT00809341|BG001|Baseline|PET Positive|Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
11367654|NCT00809341|BG002|Baseline|Total|Total of all reporting groups
11367655|NCT00809341|FG000|Participant Flow|PET Negative|Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
11367656|NCT00809341|FG001|Participant Flow|PET Positive|Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
11367657|NCT00809341|OG000|Outcome|PET Negative|Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
11367658|NCT00809341|OG001|Outcome|PET Positive|Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
11367659|NCT00809341|EG000|Reported Event|PET Negative|Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
11367660|NCT00809341|EG001|Reported Event|PET Positive|Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
11367661|NCT00804349|BG000|Baseline|Control|"Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.~0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available."
11367662|NCT00804349|BG001|Baseline|Autotitrating Positive Airway Pressure|"Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.~Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy~0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available."
11367663|NCT00804349|BG002|Baseline|Total|Total of all reporting groups
11367664|NCT00804349|FG000|Participant Flow|Control|"Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.~0 participants analyzed. The study was closed and the PI is not longer at the institution. The PI was contacted to complete requirements but the information was not added by the PI. No study data are available."
11367665|NCT00804349|FG001|Participant Flow|Autotitrating Positive Airway Pressure|"Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.~Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy~0 participants analyzed. The study was closed and the PI is not longer at the institution. The PI was contacted to complete requirements but the information was not added by the PI. No study data are available."
11367666|NCT00804349|OG000|Outcome|Control|"Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.~0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available."
11367667|NCT00804349|OG001|Outcome|Autotitrating Positive Airway Pressure|"Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.~Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy~0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available."
11367668|NCT00804349|EG000|Reported Event|Control|"Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.~0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available."
11377133|NCT03978091|BG006|Baseline|Total|Total of all reporting groups
11377134|NCT03978091|FG000|Participant Flow|AVYCAZ IV|"2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.~Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam"
11367669|NCT00804349|EG001|Reported Event|Autotitrating Positive Airway Pressure|"Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.~Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy~0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available."
11367670|NCT00803283|BG000|Baseline|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator's discretion for next 14 days of maintenance phase.
11367671|NCT00803283|BG001|Baseline|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator's discretion for next 14 days of maintenance phase.
11189361|NCT02119286|EG000|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11189362|NCT02119286|EG001|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11189363|NCT02119286|EG002|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
11189364|NCT02119299|BG000|Baseline|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
11189365|NCT02119299|FG000|Participant Flow|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
11367672|NCT00803283|BG002|Baseline|Total|Total of all reporting groups
11367673|NCT00803283|FG000|Participant Flow|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator's discretion for next 14 days of maintenance phase.
11189366|NCT02119299|OG000|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
11189367|NCT02119299|EG000|Reported Event|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
11189368|NCT02119325|BG000|Baseline|Overall Participants|
11189369|NCT02119325|FG000|Participant Flow|Sequence 1|Participants were adminisetered with Test followed by Placebo. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
11189370|NCT02119325|FG001|Participant Flow|Sequence 2|Participants were administered with Placebo followed by Test. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
11189371|NCT02119325|OG000|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).
11189372|NCT02119325|OG001|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
11189373|NCT02119325|OG000|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
11189374|NCT02119325|OG001|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water
11189375|NCT02119325|EG000|Reported Event|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
11367674|NCT00803283|FG001|Participant Flow|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator's discretion for next 14 days of maintenance phase.
11367675|NCT00803283|OG000|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator's discretion for next 14 days of maintenance phase.
11367676|NCT00803283|OG001|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator's discretion for next 14 days of maintenance phase.
11367677|NCT00803283|EG000|Reported Event|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator's discretion for next 14 days of maintenance phase.
11367678|NCT00803283|EG001|Reported Event|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator's discretion for next 14 days of maintenance phase.
11367679|NCT00811590|BG000|Baseline|All Patients|All patients enrolled/eligible.
11367680|NCT00811590|FG000|Participant Flow|All Patients|All patients enrolled/eligible.
11367681|NCT00811590|OG000|Outcome|All Patients|All enrolled/eligible patients.
11367682|NCT00811590|EG000|Reported Event|All Patients|All enrolled/eligible patients.
11367683|NCT00808899|BG000|Baseline|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
11189376|NCT02119325|EG001|Reported Event|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
11189377|NCT02119442|BG000|Baseline|Transcatheter Valve Implantation|"Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention.~Transcather Valve Implantation: Transcather Valve Implantation"
11189378|NCT02119442|FG000|Participant Flow|Transcatheter Valve Implantation|"Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention. All participants were considered to be under the same Arm/Group.~Transcather Valve Implantation: Transcather Valve Implantation"
11189379|NCT02119442|OG000|Outcome|Transcatheter Valve Implantation|"Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention.~Transcather Valve Implantation: Transcather Valve Implantation"
11367684|NCT00808899|FG000|Participant Flow|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
11189380|NCT02119442|EG000|Reported Event|Transcatheter Valve Implantation|"Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention.~Transcather Valve Implantation: Transcather Valve Implantation"
11189381|NCT02119455|BG000|Baseline|Vibration Device+Fixed Appliance Tx|"Subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.~Vibration Device: Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period."
11189382|NCT02119455|BG001|Baseline|No Vibration Device+Fixed Appliance Tx+Female|Subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment only and no vibration treatment.
11189383|NCT02119455|BG002|Baseline|Total|Total of all reporting groups
11189384|NCT02119455|FG000|Participant Flow|Vibration Device+Fixed Appliance Tx|"Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.~Vibration Device: Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period."
11367685|NCT00808899|OG000|Outcome|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
11367686|NCT00808899|EG000|Reported Event|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
11367687|NCT00808769|BG000|Baseline|All Study Participants|
11367688|NCT00808769|FG000|Participant Flow|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
11367689|NCT00808769|FG001|Participant Flow|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
11367690|NCT00808769|OG000|Outcome|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
11367691|NCT00808769|OG001|Outcome|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
11367692|NCT00808769|EG000|Reported Event|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
11367693|NCT00808769|EG001|Reported Event|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
11367694|NCT00803179|BG000|Baseline|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
11367695|NCT00803179|FG000|Participant Flow|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
11367696|NCT00803179|OG000|Outcome|Growth Hormone Therapy|"Nutropin Aqueous (AQ):~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
11367697|NCT00803179|EG000|Reported Event|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
11367698|NCT00801931|BG000|Baseline|Experimental: C: Moderate Intensity|Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
11367699|NCT00801931|FG000|Participant Flow|Experimental: C: Moderate Intensity|Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
11367700|NCT00801931|OG000|Outcome|All Subjects|Includes all subjects in the study.
11367701|NCT00801931|EG000|Reported Event|Experimental: C: Moderate Intensity|Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
11367702|NCT00793520|BG000|Baseline|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
11367703|NCT00793520|BG001|Baseline|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
11367704|NCT00793520|BG002|Baseline|Total|Total of all reporting groups
11367705|NCT00793520|FG000|Participant Flow|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
11367706|NCT00793520|FG001|Participant Flow|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
11367707|NCT00793520|OG000|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
11367708|NCT00793520|OG001|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
11367709|NCT00793520|EG000|Reported Event|Milnacipran|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
11367710|NCT00793520|EG001|Reported Event|Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
11367711|NCT00795236|BG000|Baseline|Melatonin|"Subjects with free-running rhythms will take melatonin.~Melatonin : One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study."
11367712|NCT00795236|BG001|Baseline|Observational|Observe to determine free-running versus entrained status.
11367713|NCT00795236|BG002|Baseline|Total|Total of all reporting groups
11367714|NCT00795236|FG000|Participant Flow|Melatonin|"Subjects with free-running rhythms will take melatonin.~Melatonin : One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study."
11189385|NCT02119455|FG001|Participant Flow|No Vibration Device+Fixed Appliance Tx|Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment only. No vibration appliance will be utilized by these patients.
11367715|NCT00795236|FG001|Participant Flow|Observational|Observe to determine free-running versus entrained status.
11367716|NCT00795236|OG000|Outcome|Observational|Observe to determine free-running versus entrained status.
11367717|NCT00795236|OG001|Outcome|Melatonin|"Subjects with free-running rhythms will take melatonin.~Melatonin: One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study."
11367718|NCT00795236|OG000|Outcome|Melatonin|"Subjects with free-running rhythms will take melatonin.~Melatonin : One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study."
11367719|NCT00795236|OG001|Outcome|Observational|Observe to determine free-running versus entrained status.
11367720|NCT00795236|EG000|Reported Event|Melatonin|"Subjects with free-running rhythms will take melatonin.~Melatonin : One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study."
11367721|NCT00795236|EG001|Reported Event|Observational|Observe to determine free-running versus entrained status.
11367722|NCT00799773|BG000|Baseline|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
11367723|NCT00799773|BG001|Baseline|Standard of Care|Participants will receive plasma exchange and corticosteroids.
11367724|NCT00799773|BG002|Baseline|Total|Total of all reporting groups
11367725|NCT00799773|FG000|Participant Flow|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
11367726|NCT00799773|FG001|Participant Flow|Standard of Care|Participants will receive plasma exchange and corticosteroids.
11367727|NCT00799773|OG000|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
11367728|NCT00799773|OG001|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
11367729|NCT00799773|EG000|Reported Event|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
11367730|NCT00799773|EG001|Reported Event|Standard of Care|Participants will receive plasma exchange and corticosteroids.
11367731|NCT00790452|BG000|Baseline|Group 1 (Aspirin)|Aspirin 325 mg/day orally
11367732|NCT00790452|BG001|Baseline|Group 2 (Placebo)|Tablet/day orally
11367733|NCT00790452|BG002|Baseline|Total|Total of all reporting groups
11367734|NCT00790452|FG000|Participant Flow|Group 1 (Aspirin)|Aspirin 325 mg/day orally
11367735|NCT00790452|FG001|Participant Flow|Group 2 (Placebo)|Tablet/day orally
11367736|NCT00790452|OG000|Outcome|Group 1 (Aspirin)|Aspirin 325 mg/day orally
11367737|NCT00790452|OG001|Outcome|Group 2 (Placebo)|Tablet/day orally
11367738|NCT00790452|EG000|Reported Event|Group 1 (Aspirin)|Aspirin 325 mg/day orally
11367739|NCT00790452|EG001|Reported Event|Group 2 (Placebo)|Tablet/day orally
11367740|NCT00795665|BG000|Baseline|Bevacizumab and Carmustine|"bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.~carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU."
11367741|NCT00795665|FG000|Participant Flow|Bevacizumab and Carmustine|"bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.~carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU."
11367742|NCT00795665|OG000|Outcome|Bevacizumab and Carmustine|"bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.~carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU."
11367743|NCT00795665|EG000|Reported Event|Bevacizumab and Carmustine|"bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.~carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU."
11367744|NCT00787917|BG000|Baseline|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
11367745|NCT00787917|BG001|Baseline|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
11367746|NCT00787917|BG002|Baseline|Total|Total of all reporting groups
11367747|NCT00787917|FG000|Participant Flow|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
11367748|NCT00787917|FG001|Participant Flow|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
11367749|NCT00787917|OG000|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
11367750|NCT00787917|OG001|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
11367751|NCT00787917|OG000|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
11367752|NCT00787917|EG000|Reported Event|Blinded Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
11367753|NCT00787917|EG001|Reported Event|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
11377135|NCT03978091|FG001|Participant Flow|AVYCAZ CI|"2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.~Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam"
11377136|NCT03978091|FG002|Participant Flow|ATM IV|"2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.~AZACTAM (aztreonam): A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum"
11367754|NCT00787917|EG002|Reported Event|Open Label Omalizumab|Patients who completed double-blinded phase of the study, enrolled into 6 months open label phase and continued in the same regimen of omalizumab as they were during double-blinded phase. A maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
11367755|NCT00798590|BG000|Baseline|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
11367756|NCT00798590|BG001|Baseline|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
11367757|NCT00798590|BG002|Baseline|Total|Total of all reporting groups
11367758|NCT00798590|FG000|Participant Flow|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
11367759|NCT00798590|FG001|Participant Flow|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
11367760|NCT00798590|OG000|Outcome|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
11367761|NCT00798590|OG001|Outcome|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
11367762|NCT00798590|EG000|Reported Event|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
11189386|NCT02119455|OG000|Outcome|Vibration Device+Fixed Appliance Tx|"Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.~Vibration Device: Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period."
11367763|NCT00798590|EG001|Reported Event|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
11367764|NCT00796510|BG000|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
11367765|NCT00796510|BG001|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
11367766|NCT00796510|BG002|Baseline|Total|Total of all reporting groups
11367767|NCT00796510|FG000|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
11367768|NCT00796510|FG001|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
11367769|NCT00796510|OG000|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
11367770|NCT00796510|OG001|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
11367771|NCT00796510|EG000|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
11367772|NCT00796510|EG001|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
11367773|NCT00796861|BG000|Baseline|Single Arm|"Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx~Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total)."
11367774|NCT00796861|FG000|Participant Flow|Single Arm|"Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx~Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total)."
11367775|NCT00796861|OG000|Outcome|Single Arm|"Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx~Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total)."
11367776|NCT00796861|EG000|Reported Event|Single Arm|"Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx~Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total)."
11367777|NCT00791076|BG000|Baseline|All Study Participants|"2pmol/kg-1/min-1 saline infused continuously over 72 hours OR~2pmol/kg-1/min-1 PP infused continuously over 72 hours."
11367778|NCT00791076|FG000|Participant Flow|All Participants|"Saline~Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.~OR~Pancreatic Polypeptide~Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
11367779|NCT00791076|OG000|Outcome|Saline Placebo|"Saline~Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
11367780|NCT00791076|OG001|Outcome|Pancreatic Polypeptide|"Pancreatic Polypeptide~Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
11367781|NCT00791076|EG000|Reported Event|Saline Placebo|"Saline~Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
11367782|NCT00791076|EG001|Reported Event|Pancreatic Polypeptide|"Pancreatic Polypeptide~Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
11367783|NCT00790478|BG000|Baseline|Placebo|"Placebo -- lactose pill.~Placebo: Study Placebo taken once daily, preferably an hour before bedtime, for 12 weeks."
11367784|NCT00790478|BG001|Baseline|Melatonin|"Melatonin~Melatonin: Study Pill (5 mg/d) taken once daily, preferably an hour before bedtime, for 12 weeks."
11367785|NCT00790478|BG002|Baseline|Total|Total of all reporting groups
11367786|NCT00790478|FG000|Participant Flow|Melatonin|Melatonin
11367787|NCT00790478|FG001|Participant Flow|Placebo|
11367788|NCT00790478|OG000|Outcome|Melatonin|Melatonin
11367789|NCT00790478|OG001|Outcome|Placebo|Placebo
11367790|NCT00790478|EG000|Reported Event|Melatonin|Melatonin
11367791|NCT00790478|EG001|Reported Event|Placebo|Placebo
11367792|NCT00796107|BG000|Baseline|R1507 in Combination With Letrozole|Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
11367793|NCT00796107|FG000|Participant Flow|R1507 in Combination With Letrozole|Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
11367794|NCT00796107|OG000|Outcome|R1507 in Combination With Letrozole|Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
11367795|NCT00796107|EG000|Reported Event|R1507 in Combination With Letrozole|Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
11367796|NCT00791336|BG000|Baseline|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
11367797|NCT00791336|FG000|Participant Flow|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
11367798|NCT00791336|OG000|Outcome|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
11367799|NCT00791336|EG000|Reported Event|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
11367800|NCT00786682|BG000|Baseline|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
11240144|NCT02476565|FG001|Participant Flow|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
11367801|NCT00786682|FG000|Participant Flow|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
11367802|NCT00786682|OG000|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
11367803|NCT00786682|EG000|Reported Event|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
11367804|NCT00787124|BG000|Baseline|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
11367805|NCT00787124|BG001|Baseline|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
11367806|NCT00787124|BG002|Baseline|Total|Total of all reporting groups
11367807|NCT00787124|FG000|Participant Flow|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
11367808|NCT00787124|FG001|Participant Flow|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
11367809|NCT00787124|OG000|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
11367810|NCT00787124|OG001|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
11367811|NCT00787124|EG000|Reported Event|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
11367812|NCT00787124|EG001|Reported Event|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
11367813|NCT00785356|BG000|Baseline|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
11367814|NCT00785356|BG001|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
11367815|NCT00785356|BG002|Baseline|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
11367816|NCT00785356|BG003|Baseline|Total|Total of all reporting groups
11367817|NCT00785356|FG000|Participant Flow|All Groups|Proellex 25 mg, Proellex 50 mg, 1placebo
11367818|NCT00785356|OG000|Outcome|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
11367819|NCT00785356|OG001|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
11367820|NCT00785356|OG002|Outcome|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
11367821|NCT00785356|EG000|Reported Event|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
11367822|NCT00785356|EG001|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
11367823|NCT00785356|EG002|Reported Event|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
11367824|NCT00782483|BG000|Baseline|Overall|Overall Study Group
11367825|NCT00782483|FG000|Participant Flow|Laser Therapy|Total number of participants
11367826|NCT00782483|OG000|Outcome|Laser Therapy|Total number of participants
11367827|NCT00782483|EG000|Reported Event|Overall|Overall Study Group
11367828|NCT00791843|BG000|Baseline|GHRH and Placebo|"Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo~Growth hormone releasing hormone/ placebo: 12 weeks of drug at max dose of 2mg/day administered in 4 pulses at 11pm, 1am, 3am, and 5am, followed by 6 weeks of washout period, then 12 weeks of placebo or vise versa- 12 weeks of placebo, 6 weeks washout, 12 weeks of drug."
11367829|NCT00791843|FG000|Participant Flow|GHRH and Placebo|"Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo~Growth hormone releasing hormone/ placebo: 12 weeks of drug at max dose of 2mg/day administered in 4 pulses at 11pm, 1am, 3am, and 5am, followed by 6 weeks of washout period, then 12 weeks of placebo or vise versa- 12 weeks of placebo, 6 weeks washout, 12 weeks of drug."
11367830|NCT00791843|OG000|Outcome|GHRH and Placebo|"Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo~Growth hormone releasing hormone/ placebo: 12 weeks of drug at max dose of 2mg/day administered in 4 pulses at 11pm, 1am, 3am, and 5am, followed by 6 weeks of washout period, then 12 weeks of placebo or vise versa- 12 weeks of placebo, 6 weeks washout, 12 weeks of drug."
11377137|NCT03978091|FG003|Participant Flow|ATM CI|"2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.~AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum"
11367831|NCT00791843|EG000|Reported Event|GHRH and Placebo|"Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo~Growth hormone releasing hormone/ placebo: 12 weeks of drug at max dose of 2mg/day administered in 4 pulses at 11pm, 1am, 3am, and 5am, followed by 6 weeks of washout period, then 12 weeks of placebo or vise versa- 12 weeks of placebo, 6 weeks washout, 12 weeks of drug."
11367832|NCT00784043|BG000|Baseline|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
11367833|NCT00784043|BG001|Baseline|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
11367834|NCT00784043|BG002|Baseline|Total|Total of all reporting groups
11189387|NCT02119455|OG001|Outcome|No Vibration Device+Fixed Appliance Tx|"Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.~Vibration Device: Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period."
11189388|NCT02119455|EG000|Reported Event|Vibration Device+Fixed Appliance Tx|"Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.~Vibration Device: Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period."
11189389|NCT02119455|EG001|Reported Event|No Vibration Device+Fixed Appliance Tx|Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment only and no vibration treatment.
11189390|NCT02119650|BG000|Baseline|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
11189391|NCT02119650|BG001|Baseline|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
11367835|NCT00784043|FG000|Participant Flow|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
11367836|NCT00784043|FG001|Participant Flow|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
11367837|NCT00784043|OG000|Outcome|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
11367838|NCT00784043|OG001|Outcome|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
11189392|NCT02119650|BG002|Baseline|Total|Total of all reporting groups
11189393|NCT02119650|FG000|Participant Flow|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg twice daily (BID) oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
11189394|NCT02119650|FG001|Participant Flow|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
11189395|NCT02119650|OG000|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
11367839|NCT00784043|EG000|Reported Event|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
11367840|NCT00784043|EG001|Reported Event|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
11367841|NCT00787618|BG000|Baseline|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
11367842|NCT00787618|BG001|Baseline|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
11367843|NCT00787618|BG002|Baseline|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
11367844|NCT00787618|BG003|Baseline|Total|Total of all reporting groups
11367845|NCT00787618|FG000|Participant Flow|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
11367846|NCT00787618|FG001|Participant Flow|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
11367847|NCT00787618|FG002|Participant Flow|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
11367848|NCT00787618|OG000|Outcome|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
11367849|NCT00787618|OG001|Outcome|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
11367850|NCT00787618|OG002|Outcome|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
11367851|NCT00787618|EG000|Reported Event|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
11367852|NCT00787618|EG001|Reported Event|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
11189396|NCT02119650|OG001|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
11189397|NCT02119650|EG000|Reported Event|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
11189398|NCT02119650|EG001|Reported Event|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
11189399|NCT02119663|BG000|Baseline|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189400|NCT02119663|BG001|Baseline|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189401|NCT02119663|BG002|Baseline|Total|Total of all reporting groups
11189402|NCT02119663|FG000|Participant Flow|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189403|NCT02119663|FG001|Participant Flow|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189404|NCT02119663|OG000|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11367853|NCT00787618|EG002|Reported Event|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
11367854|NCT00774306|BG000|Baseline|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses."
11189405|NCT02119663|OG001|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189406|NCT02119663|EG000|Reported Event|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11189407|NCT02119663|EG001|Reported Event|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
11367855|NCT00774306|BG001|Baseline|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
11367856|NCT00774306|BG002|Baseline|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
11189408|NCT02119676|BG000|Baseline|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189409|NCT02119676|BG001|Baseline|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189410|NCT02119676|BG002|Baseline|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189411|NCT02119676|BG003|Baseline|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189412|NCT02119676|BG004|Baseline|Total|Total of all reporting groups
11189413|NCT02119676|FG000|Participant Flow|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg twice a day (BID) continuous with regorafenib 160 mg once daily (QD) for the first 21 days of each 28-day cycle.
11189414|NCT02119676|FG001|Participant Flow|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189415|NCT02119676|FG002|Participant Flow|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189416|NCT02119676|FG003|Participant Flow|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189417|NCT02119676|OG000|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189418|NCT02119676|OG001|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189419|NCT02119676|OG002|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11367857|NCT00774306|BG003|Baseline|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
11367858|NCT00774306|BG004|Baseline|Total|Total of all reporting groups
11189420|NCT02119676|OG003|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189421|NCT02119676|EG000|Reported Event|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189422|NCT02119676|EG001|Reported Event|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189423|NCT02119676|EG002|Reported Event|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189424|NCT02119676|EG003|Reported Event|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
11189425|NCT02119819|BG000|Baseline|10 mg LY2944876|10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
11189426|NCT02119819|BG001|Baseline|15 mg LY2944876|15 mg LY2944876 given SC once weekly for 24 weeks.
11189427|NCT02119819|BG002|Baseline|30 mg LY2944876|30 mg LY2944876 given SC once weekly for 24 weeks.
11189428|NCT02119819|BG003|Baseline|50 mg LY2944876|50 mg LY2944876 given SC once weekly for 24 weeks.
11189429|NCT02119819|BG004|Baseline|Exenatide Extended-release|2 mg exenatide extended-release given SC once weekly for 24 weeks.
11189430|NCT02119819|BG005|Baseline|Placebo|Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
11189431|NCT02119819|BG006|Baseline|Total|Total of all reporting groups
11189432|NCT02119819|FG000|Participant Flow|10 mg LY2944876|10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks, plus background PO metformin.
11189433|NCT02119819|FG001|Participant Flow|15 mg LY2944876|15 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
11189434|NCT02119819|FG002|Participant Flow|30 mg LY2944876|30 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
11189435|NCT02119819|FG003|Participant Flow|50 mg LY2944876|50 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
11189436|NCT02119819|FG004|Participant Flow|Exenatide Extended-release|2 mg exenatide extended-release given SC once weekly for 24 weeks, plus background PO metformin..
11189437|NCT02119819|FG005|Participant Flow|Placebo|Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks,plus background PO metformin. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
11189438|NCT02119819|OG000|Outcome|10 mg LY2944876|10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
11189439|NCT02119819|OG001|Outcome|15 mg LY2944876|15 mg LY2944876 given SC once weekly for 24 weeks.
11189440|NCT02119819|OG002|Outcome|30 mg LY2944876|30 mg LY2944876 given SC once weekly for 24 weeks.
11189441|NCT02119819|OG003|Outcome|50 mg LY2944876|50 mg LY2944876 given SC once weekly for 24 weeks.
11189442|NCT02119819|OG004|Outcome|Exenatide Extended-release|2 mg exenatide extended-release given SC once weekly for 24 weeks.
11189443|NCT02119819|OG005|Outcome|Placebo|Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
11189444|NCT02119819|EG000|Reported Event|10 mg LY2944876|10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
11189445|NCT02119819|EG001|Reported Event|15 mg LY2944876|15 mg LY2944876 given SC once weekly for 24 weeks.
11189446|NCT02119819|EG002|Reported Event|30 mg LY2944876|30 mg LY2944876 given SC once weekly for 24 weeks.
11189447|NCT02119819|EG003|Reported Event|50 mg LY2944876|50 mg LY2944876 given SC once weekly for 24 weeks.
11189448|NCT02119819|EG004|Reported Event|Exenatide Extended-release|2 mg exenatide extended-release given SC once weekly for 24 weeks.
11189449|NCT02119819|EG005|Reported Event|Placebo|Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
11189450|NCT02119871|BG000|Baseline|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
11189451|NCT02119871|BG001|Baseline|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
11189452|NCT02119871|BG002|Baseline|Total|Total of all reporting groups
11189453|NCT02119871|FG000|Participant Flow|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
11189454|NCT02119871|FG001|Participant Flow|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
11189455|NCT02119871|OG000|Outcome|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
11189456|NCT02119871|OG001|Outcome|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
11189457|NCT02119871|EG000|Reported Event|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
11189458|NCT02119871|EG001|Reported Event|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
11189459|NCT02119936|BG000|Baseline|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
11189460|NCT02119936|FG000|Participant Flow|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback (HRVB) tool (emWave 2) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
11189461|NCT02119936|OG000|Outcome|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
11189462|NCT02119936|EG000|Reported Event|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
11189463|NCT02120001|BG000|Baseline|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
11189464|NCT02120001|BG001|Baseline|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
11189465|NCT02120001|BG002|Baseline|Total|Total of all reporting groups
11189466|NCT02120001|FG000|Participant Flow|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
11189467|NCT02120001|FG001|Participant Flow|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
11189468|NCT02120001|OG000|Outcome|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
11189469|NCT02120001|OG001|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
11189470|NCT02120001|EG000|Reported Event|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
11189471|NCT02120001|EG001|Reported Event|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
11189472|NCT02120027|BG000|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
11189473|NCT02120027|BG001|Baseline|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
11189474|NCT02120027|BG002|Baseline|Total|Total of all reporting groups
11189475|NCT02120027|FG000|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
11189476|NCT02120027|FG001|Participant Flow|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet (identical in appearance and weight to ibodutant tablets) to be given once daily."
11189477|NCT02120027|OG000|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
11189478|NCT02120027|OG001|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
11189479|NCT02120027|EG000|Reported Event|Ibodutant 10 mg for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
11189480|NCT02120027|EG001|Reported Event|Placebo for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
11189481|NCT02120157|BG000|Baseline|Haploidentical BMT With PTCy for Acute Leukemias and MDS|"Patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS):~Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV~For patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma:~Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: total body irradiation (TBI) 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered"
11191691|NCT02133001|BG001|Baseline|Esketamine 84 mg|Participants self-administered 1 spray into each nostril (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) of Esketamine 84 milligram (mg) twice Weekly for 4 Weeks on Days 1, 4, 8, 11, 15, 18, 22, and Day 25 along with standard of care antidepressant treatment (determined by the treating physician based on clinical judgment) on Day 1 and continued for the duration of the double-blind treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to esketamine 56 mg was permitted if a participant was unable to tolerate the intranasal esketamine 84 mg. Participants continued to receive the reduced dose for the duration of the double-blind treatment phase.
11191692|NCT02133001|BG002|Baseline|Total|Total of all reporting groups
11189482|NCT02120157|FG000|Participant Flow|Haploidentical BMT With PTCy for Acute Leukemias and MDS|"Patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS):~Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV~For patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma:~Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: total body irradiation (TBI) 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered"
11191693|NCT02133001|FG000|Participant Flow|Placebo|Participants received intranasal placebo (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) administered twice weekly for 4 weeks on days 1, 4, 8, 11, 15, 18, 22, and 25 along with standard of care antidepressant treatment (determined by the treating physician based on clinical judgment) on Day 1 and continued for the duration of the double-blind treatment phase.
11367859|NCT00774306|FG000|Participant Flow|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.~x~x"
11367860|NCT00774306|FG001|Participant Flow|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
11367861|NCT00774306|FG002|Participant Flow|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
11367862|NCT00774306|FG003|Participant Flow|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
11367863|NCT00774306|OG000|Outcome|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.~x~x"
11367864|NCT00774306|OG001|Outcome|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
11367865|NCT00774306|OG002|Outcome|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
11367866|NCT00774306|OG003|Outcome|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
11367867|NCT00774306|EG000|Reported Event|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.~x~x"
11367868|NCT00774306|EG001|Reported Event|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
11367869|NCT00774306|EG002|Reported Event|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
11367870|NCT00774306|EG003|Reported Event|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
11367871|NCT00771602|BG000|Baseline|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
11367872|NCT00771602|BG001|Baseline|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
11367873|NCT00771602|BG002|Baseline|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
11367874|NCT00771602|BG003|Baseline|Total|Total of all reporting groups
11367875|NCT00771602|FG000|Participant Flow|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
11367876|NCT00771602|FG001|Participant Flow|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
11367877|NCT00771602|FG002|Participant Flow|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
11367878|NCT00771602|OG000|Outcome|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
11367879|NCT00771602|OG001|Outcome|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
11367880|NCT00771602|OG002|Outcome|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
11367881|NCT00771602|EG000|Reported Event|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
11367882|NCT00771602|EG001|Reported Event|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
11367883|NCT00771602|EG002|Reported Event|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
11367884|NCT00779038|BG000|Baseline|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
11367885|NCT00779038|FG000|Participant Flow|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
11367886|NCT00779038|OG000|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
11367887|NCT00779038|EG000|Reported Event|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
11367888|NCT00780455|BG000|Baseline|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
11367889|NCT00780455|BG001|Baseline|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
11367890|NCT00780455|BG002|Baseline|Total|Total of all reporting groups
11367891|NCT00780455|FG000|Participant Flow|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
11367892|NCT00780455|FG001|Participant Flow|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
11367893|NCT00780455|OG000|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
11367894|NCT00780455|OG001|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
11367895|NCT00780455|EG000|Reported Event|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
11367896|NCT00780455|EG001|Reported Event|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
11367897|NCT00776100|BG000|Baseline|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
11367898|NCT00776100|BG001|Baseline|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
11367899|NCT00776100|BG002|Baseline|Total|Total of all reporting groups
11367900|NCT00776100|FG000|Participant Flow|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
11367901|NCT00776100|FG001|Participant Flow|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
11367902|NCT00776100|OG000|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
11367903|NCT00776100|OG001|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
11367904|NCT00776100|EG000|Reported Event|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
11367905|NCT00776100|EG001|Reported Event|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
11367906|NCT00771316|BG000|Baseline|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
11367907|NCT00771316|BG001|Baseline|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
11367908|NCT00771316|BG002|Baseline|Total|Total of all reporting groups
11367909|NCT00771316|FG000|Participant Flow|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
11367910|NCT00771316|FG001|Participant Flow|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
11367911|NCT00771316|OG000|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
11367912|NCT00771316|OG001|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
11336869|NCT03572972|BG003|Baseline|Warfarin|OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for warfarin was defined as the first prescription date of warfarin during the intake period from 1-July-2015 to 30-November-2016.
11336870|NCT03572972|BG004|Baseline|Aspirin|OACs treatment-naive participants diagnosed with NVAF, who initiated aspirin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for aspirin was defined as the first prescription date of aspirin during the intake period from 1-July-2015 to 30-November-2016.
11336871|NCT03572972|BG005|Baseline|Total|Total of all reporting groups
11336872|NCT03572972|FG000|Participant Flow|NOAC - Apixaban|Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for apixaban was defined as the first prescription date of apixaban during the intake period from 1-July-2015 to 30-November-2016.
11336873|NCT03572972|FG001|Participant Flow|NOAC - Dabigatran|OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for dabigatran was defined as the first prescription date of dabigatran during the intake period from 1-July-2015 to 30-November-2016.
11336874|NCT03572972|FG002|Participant Flow|NOAC - Rivaroxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for rivaroxaban was defined as the first prescription date of rivaroxaban during the intake period from 1-July-2015 to 30-November-2016.
11336875|NCT03572972|FG003|Participant Flow|Warfarin|OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for warfarin was defined as the first prescription date of warfarin during the intake period from 1-July-2015 to 30-November-2016.
11336876|NCT03572972|FG004|Participant Flow|Aspirin|OACs treatment-naive participants diagnosed with NVAF, who initiated aspirin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for aspirin was defined as the first prescription date of aspirin during the intake period from 1-July-2015 to 30-November-2016.
11336877|NCT03572972|OG000|Outcome|Apixaban vs Warfarin (Apixaban)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
11336878|NCT03572972|OG001|Outcome|Apixaban vs Warfarin (Warfarin)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
11336879|NCT03572972|OG002|Outcome|Dabigatran vs Warfarin (Dabigatran)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
11336880|NCT03572972|OG003|Outcome|Dabigatran vs Warfarin (Warfarin)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
11336881|NCT03572972|OG004|Outcome|Rivaroxaban vs Warfarin (Rivaroxaban)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
11336882|NCT03572972|OG005|Outcome|Rivaroxaban vs Warfarin (Warfarin)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
11336883|NCT03572972|OG000|Outcome|Apixaban vs Dabigatran (Apixaban)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with dabigatran using IPTW.
11336884|NCT03572972|OG001|Outcome|Apixaban vs Dabigatran (Dabigatran)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with apixaban using IPTW.
11336885|NCT03572972|OG002|Outcome|Apixaban vs Rivaroxaban (Apixaban)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with rivaroxaban using IPTW.
11336886|NCT03572972|OG003|Outcome|Apixaban vs Rivaroxaban (Rivaroxaban)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with apixaban using IPTW.
11336887|NCT03572972|OG004|Outcome|Dabigatran vs Rivaroxaban (Dabigatran)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with rivaroxaban using IPTW.
11336888|NCT03572972|OG005|Outcome|Dabigatran vs Rivaroxaban (Rivaroxaban)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with dabigatran using IPTW.
11336889|NCT03572972|OG000|Outcome|Apixaban vs Warfarin (Apixaban)|OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using IPTW.
11336890|NCT03572972|EG000|Reported Event|NOAC - Apixaban|Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for apixaban was defined as the first prescription date of apixaban during the intake period from 1-July-2015 to 30-November-2016.
11336891|NCT03572972|EG001|Reported Event|NOAC - Dabigatran|OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for dabigatran was defined as the first prescription date of dabigatran during the intake period from 1-July-2015 to 30-November-2016.
11336892|NCT03572972|EG002|Reported Event|NOAC - Rivaroxaban|OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for rivaroxaban was defined as the first prescription date of rivaroxaban during the intake period from 1-July-2015 to 30-November-2016.
11367913|NCT00771316|EG000|Reported Event|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
11367914|NCT00771316|EG001|Reported Event|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
11367915|NCT00780481|BG000|Baseline|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
11367916|NCT00780481|FG000|Participant Flow|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
11367917|NCT00780481|OG000|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
11367918|NCT00780481|EG000|Reported Event|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
11367919|NCT00769652|BG000|Baseline|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
11367920|NCT00769652|BG001|Baseline|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
11367921|NCT00769652|BG002|Baseline|Total|Total of all reporting groups
11367922|NCT00769652|FG000|Participant Flow|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
11367923|NCT00769652|FG001|Participant Flow|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
11191694|NCT02133001|FG001|Participant Flow|Esketamine 84 mg|Participants self-administered 1 spray into each nostril (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) of Esketamine 84 milligram (mg) twice Weekly for 4 Weeks on Days 1, 4, 8, 11, 15, 18, 22, and Day 25 along with standard of care antidepressant treatment (determined by the treating physician based on clinical judgment) on Day 1 and continued for the duration of the double-blind treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to esketamine 56 mg was permitted if a participant was unable to tolerate the intranasal esketamine 84 mg. Participants continued to receive the reduced dose for the duration of the double-blind treatment phase.
11367924|NCT00769652|OG000|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
11367925|NCT00769652|OG001|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
11367926|NCT00769652|EG000|Reported Event|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
11367927|NCT00769652|EG001|Reported Event|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
11367928|NCT00768040|BG000|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
11367929|NCT00768040|BG001|Baseline|Placebo|Matching placebo once daily for 12 weeks
11367930|NCT00768040|BG002|Baseline|Total|Total of all reporting groups
11367931|NCT00768040|FG000|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
11367932|NCT00768040|FG001|Participant Flow|Placebo|Matching placebo once daily for 12 weeks
11367933|NCT00768040|OG000|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
11367934|NCT00768040|OG001|Outcome|Placebo|Matching placebo once daily for 12 weeks
11367935|NCT00768040|EG000|Reported Event|Aliskiren 300mg|Aliskiren 300 mg once daily for 12 weeks
11367936|NCT00768040|EG001|Reported Event|Placebo|Matching placebo once daily for 12 weeks
11367937|NCT00776555|BG000|Baseline|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
11367938|NCT00776555|BG001|Baseline|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
11367939|NCT00776555|BG002|Baseline|Total|Total of all reporting groups
11367940|NCT00776555|FG000|Participant Flow|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
11367941|NCT00776555|FG001|Participant Flow|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
11367942|NCT00776555|OG000|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
11367943|NCT00776555|OG001|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
11367944|NCT00776555|EG000|Reported Event|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
11367945|NCT00776555|EG001|Reported Event|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
11367946|NCT00775190|BG000|Baseline|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
11367947|NCT00775190|BG001|Baseline|Trinessa™|Trinessa: generic oral contraceptive
11367948|NCT00775190|BG002|Baseline|Total|Total of all reporting groups
11367949|NCT00775190|FG000|Participant Flow|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
11367950|NCT00775190|FG001|Participant Flow|Trinessa™|Trinessa: generic oral contraceptive
11367951|NCT00775190|OG000|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
11367952|NCT00775190|OG001|Outcome|Trinessa™|Trinessa: generic oral contraceptive
11367953|NCT00775190|EG000|Reported Event|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
11367954|NCT00775190|EG001|Reported Event|Trinessa™|Trinessa: generic oral contraceptive
11367955|NCT00755261|BG000|Baseline|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
11367956|NCT00755261|FG000|Participant Flow|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
11367957|NCT00755261|OG000|Outcome|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
11367958|NCT00755261|EG000|Reported Event|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
11367959|NCT00762723|BG000|Baseline|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367960|NCT00762723|BG001|Baseline|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11189483|NCT02120157|OG000|Outcome|Haploidentical BMT With PTCy for Acute Leukemias and MDS|"Patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS):~Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV~For patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma:~Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: total body irradiation (TBI) 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered"
11189484|NCT02120157|OG000|Outcome|Haploidentical BMT With PTCy for Acute Leukemias and MDS|"Patients with AML and MDS:~Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV~For patients with ALL and lymphoblastic lymphoma:~Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: TBI 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered"
11189485|NCT02120157|OG000|Outcome|Haploidentical BMT With PTCy for Acute Leukemias and MDS|"Patients with AML and MDS:~Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days~Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV~For patients with ALL and lymphoblastic lymphoma:~Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV~Days -3 through -1: TBI 200 Centigray (cGy) twice a day for 3 days~All patients Day 0: Infuse unmanipulated bone marrow~Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV~Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day~Day +30: Assess chimerism and disease status in bone marrow~Day +35: Discontinue MMF~Day +60: Assess chimerism and disease status in bone marrow~Day 180: Discontinue tacrolimus~Cyclophosphamide: Chemotherapy administration~TBI: Radiation Therapy~Busulfan: Chemotherapy Administered~Unmanipulated Bone Marrow: Bone Marrow Transplant~Tacrolimus: Immunosuppressive Drug Administered~Mycophenolate mofetil: Immunosuppressive Drug Administered"
11189486|NCT02120157|EG000|Reported Event|Haploidentical BMT With PTCy for Acute Leukemias and MDS|"Patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS):~Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV~For patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma:~Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: total body irradiation (TBI) 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered"
11189487|NCT02120261|BG000|Baseline|TPI With Normal Saline|Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
11189488|NCT02120261|BG001|Baseline|TPI With Lidocaine & Triamcinolone Acetonide|Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
11189489|NCT02120261|BG002|Baseline|Total|Total of all reporting groups
11189490|NCT02120261|FG000|Participant Flow|TPI With Normal Saline|Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
11189491|NCT02120261|FG001|Participant Flow|TPI With Lidocaine & Triamcinolone Acetonide|Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
11189492|NCT02120261|OG000|Outcome|TPI With Normal Saline|Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
11189493|NCT02120261|OG001|Outcome|TPI With Lidocaine & Triamcinolone Acetonide|Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
11367961|NCT00762723|BG002|Baseline|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367962|NCT00762723|BG003|Baseline|Total|Total of all reporting groups
11367963|NCT00762723|FG000|Participant Flow|ALP With Fixed Screws|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367964|NCT00762723|FG001|Participant Flow|ALP With Variable Screws|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367965|NCT00762723|FG002|Participant Flow|ALP With Hybrid Screws|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367966|NCT00762723|OG000|Outcome|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367967|NCT00762723|OG001|Outcome|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367968|NCT00762723|OG002|Outcome|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367969|NCT00762723|EG000|Reported Event|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367970|NCT00762723|EG001|Reported Event|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367971|NCT00762723|EG002|Reported Event|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
11367972|NCT00770965|BG000|Baseline|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
11367973|NCT00770965|BG001|Baseline|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
11367974|NCT00770965|BG002|Baseline|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
11367975|NCT00770965|BG003|Baseline|Placebo|Participants received placebo to AIN457A IV on day 1.
11367976|NCT00770965|BG004|Baseline|Total|Total of all reporting groups
11367977|NCT00770965|FG000|Participant Flow|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
11367978|NCT00770965|FG001|Participant Flow|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
11367979|NCT00770965|FG002|Participant Flow|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
11367980|NCT00770965|FG003|Participant Flow|Placebo|Participants received placebo to AIN457A IV on day 1.
11367981|NCT00770965|OG000|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
11367982|NCT00770965|OG001|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
11367983|NCT00770965|OG002|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
11367984|NCT00770965|OG003|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
11367985|NCT00770965|EG000|Reported Event|AIN457 0.3 mg/kg|AIN457 0.3 mg/kg
11367986|NCT00770965|EG001|Reported Event|AIN457 1 mg/kg|AIN457 1 mg/kg
11367987|NCT00770965|EG002|Reported Event|AIN457 3 mg/kg|AIN457 3 mg/kg
11367988|NCT00770965|EG003|Reported Event|Placebo|Placebo
11367989|NCT00769002|BG000|Baseline|Influenza Vaccine FluShield, FluMist|Group I - Previous influenza positivity A or B within the past 5 years
11367990|NCT00769002|BG001|Baseline|Cytokine Profiling FluShield, FluMist|Group II - History of FluMist vaccination within the past 2 years
11367991|NCT00769002|BG002|Baseline|Unilateral TIV Injections FluShield|Group III a - History of TIV vaccination, any number of times, but only in a single (e.g., non-dominant) arm. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa).
11367992|NCT00769002|BG003|Baseline|Opposite Arm FluShield|Group IIIb - Within one month of screening and baseline blood draws for PBMCs and Ab titers, individuals will receive FluShield injections. The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).
11367993|NCT00769002|BG004|Baseline|Total|Total of all reporting groups
11367994|NCT00769002|FG000|Participant Flow|PET-CT Scan Influenza Vaccine Response|"Previous influenza positivity~FluShield, FluMist: Flu vaccine~Previous influenza positivity~Primary Outcome Measure:~Not Posted PET-CT Scan [Time Frame: 4-7 days after flu vaccine]~Secondary Outcome Measures:~Not Posted Cytokine Profiling [Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity~Primary Outcome Measure:~Not Posted PET-CT Scan [Time Frame: 4-7 days after flu vaccine]~Secondary Outcome Measures:~Not Posted Cytokine Profiling [Time Frame: 2-6 weeks and 10-12 months post flu vaccination"
11367995|NCT00769002|FG001|Participant Flow|Cytokine Profiling|"No previous influenza positivity~FluShield, FluMist: Flu vaccine~Primary Outcome Measure:~Not Posted PET-CT Scan [Time Frame: 4-7 days after flu vaccine]~Secondary Outcome Measures:~Not Posted Cytokine Profiling [Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity~Primary Outcome Measure:~Not Posted PET-CT Scan [Time Frame: 4-7 days after flu vaccine]~Secondary Outcome Measures:~Not Posted Cytokine Profiling [Time Frame: 2-6 weeks and 10-12 months post flu vaccination"
11367996|NCT00769002|OG000|Outcome|PET-CT Scan Influenza Vaccine Response|"Previous influenza positivity~FluShield, FluMist: Flu vaccine~Previous influenza positivity~Primary Outcome Measure:~Not Posted PET-CT Scan [Time Frame: 4-7 days after flu vaccine]~Secondary Outcome Measures:~Not Posted Cytokine Profiling [Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity~Primary Outcome Measure:~Not Posted PET-CT Scan [Time Frame: 4-7 days after flu vaccine]~Secondary Outcome Measures:~Not Posted Cytokine Profiling [Time Frame: 2-6 weeks and 10-12 months post flu vaccination"
11367997|NCT00769002|EG000|Reported Event|Influenza Vaccine FluShield, FluMist|"Previous influenza positivity~Primary Outcome Measure:~PET-CT Scan [Time Frame: 4-7 days after flu vaccine]~Secondary Outcome Measures:~Cytokine Profiling [Time Frame: 2-6 weeks and 10-12 months post flu vaccination~FluShield, FluMist: Flu vaccine"
11367998|NCT00769002|EG001|Reported Event|Cytokine Profiling FluShield, FluMist|"No previous influenza positivity~Primary Outcome Measure:~PET-CT Scan [Time Frame: 4-7 days after flu vaccine]~Secondary Outcome Measures:~Cytokine Profiling [Time Frame: 2-6 weeks and 10-12 months post flu vaccination~FluShield, FluMist: Flu vaccine"
11367999|NCT00766636|BG000|Baseline|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
11368000|NCT00766636|BG001|Baseline|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
11368001|NCT00766636|BG002|Baseline|Total|Total of all reporting groups
11368002|NCT00766636|FG000|Participant Flow|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
11368003|NCT00766636|FG001|Participant Flow|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
11368004|NCT00766636|OG000|Outcome|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
11368005|NCT00766636|OG001|Outcome|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
11189494|NCT02120261|EG000|Reported Event|TPI With Normal Saline|"Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.~Normal Saline: Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point."
11368006|NCT00766636|EG000|Reported Event|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
11368007|NCT00766636|EG001|Reported Event|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
11368008|NCT00768248|BG000|Baseline|Active|"3-7 days of perineural local anesthetic infusion~perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h"
11368009|NCT00768248|BG001|Baseline|Placebo|"3-7 days of perineural normal saline infusion~normal saline (placebo): the basal rate will be set at 7 mL/h"
11368010|NCT00768248|BG002|Baseline|Total|Total of all reporting groups
11368011|NCT00768248|FG000|Participant Flow|Active|"3-7 days of perineural local anesthetic infusion~perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h"
11368012|NCT00768248|FG001|Participant Flow|Placebo|"3-7 days of perineural normal saline infusion~normal saline (placebo): the basal rate will be set at 7 mL/h"
11368013|NCT00768248|OG000|Outcome|Active|"3-7 days of perineural local anesthetic infusion~perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h"
11368014|NCT00768248|OG001|Outcome|Placebo|"3-7 days of perineural normal saline infusion~normal saline (placebo): the basal rate will be set at 7 mL/h"
11368015|NCT00768248|EG000|Reported Event|Active|"3-7 days of perineural local anesthetic infusion~perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h"
11368016|NCT00768248|EG001|Reported Event|Placebo|"3-7 days of perineural normal saline infusion~normal saline (placebo): the basal rate will be set at 7 mL/h"
11368017|NCT00765765|BG000|Baseline|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
11368018|NCT00765765|FG000|Participant Flow|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
11368019|NCT00765765|OG000|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
11368020|NCT00765765|EG000|Reported Event|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
11368021|NCT00764699|BG000|Baseline|rhIGF|"Treatment with rhIGF (Increlex)~rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID."
11368022|NCT00764699|FG000|Participant Flow|rhIGF|"Treatment with rhIGF (Increlex)~rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID."
11368023|NCT00764699|OG000|Outcome|rhIGF|"Treatment with rhIGF (Increlex)~rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID."
11368024|NCT00764699|EG000|Reported Event|rhIGF|"Treatment with rhIGF (Increlex)~rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID."
11368025|NCT00759577|BG000|Baseline|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
11368026|NCT00759577|FG000|Participant Flow|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
11368027|NCT00759577|OG000|Outcome|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
11368028|NCT00759577|EG000|Reported Event|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
11368029|NCT00763009|BG000|Baseline|Dipyridamole|Pre: Baseline Results prior to administration of Dipyridamole. Post: Results post adminsitration of Dipyridamole
11368030|NCT00763009|FG000|Participant Flow|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
11368031|NCT00763009|OG000|Outcome|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
11368032|NCT00763009|OG000|Outcome|All Subjects Receive Dipyridamole|There is only a single arm dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
11368033|NCT00763009|EG000|Reported Event|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
11368034|NCT00761176|BG000|Baseline|Active|The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
11368035|NCT00761176|BG001|Baseline|Standard of Care|Standardized wound care is used
11368036|NCT00761176|BG002|Baseline|Total|Total of all reporting groups
11368037|NCT00761176|FG000|Participant Flow|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
11368038|NCT00761176|FG001|Participant Flow|Active|Provant Therapy Device
11368039|NCT00761176|OG000|Outcome|Standard of Care|Standard of Care will be utilized without the device.
11368040|NCT00761176|OG001|Outcome|Active Provant Device|"Active Device~The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device."
11368041|NCT00761176|EG000|Reported Event|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
11368042|NCT00761176|EG001|Reported Event|Active|Provant Therapy Device
11368043|NCT00749476|BG000|Baseline|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
11368044|NCT00749476|FG000|Participant Flow|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
11368045|NCT00749476|OG000|Outcome|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
11368046|NCT00749476|EG000|Reported Event|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
11368047|NCT00760461|BG000|Baseline|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
11368048|NCT00760461|FG000|Participant Flow|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
11368049|NCT00760461|OG000|Outcome|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
11368050|NCT00760461|EG000|Reported Event|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
11368051|NCT00749658|BG000|Baseline|Bupropion + Placebo Varenicline|"Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline~Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.~Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d."
11368052|NCT00749658|BG001|Baseline|Upropion + Varenicline|"Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline~Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.~Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d."
11368053|NCT00749658|BG002|Baseline|Total|Total of all reporting groups
11368054|NCT00749658|FG000|Participant Flow|Bupropion + Placebo Varenicline|"Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline~Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.~Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d."
11368055|NCT00749658|FG001|Participant Flow|Varenicline + Placebo Bupropion|"Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline~Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.~Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d."
11368056|NCT00749658|OG000|Outcome|Bupropion + Placebo Varenicline|"Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline~Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.~Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d."
11368057|NCT00749658|OG001|Outcome|Varenicline + Placebo Bupropion|"Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline~Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.~Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d."
11368058|NCT00749658|EG000|Reported Event|Bupropion + Placebo Varenicline|"Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline~Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.~Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d."
11368059|NCT00749658|EG001|Reported Event|Varenicline + Placebo Bupropion|"Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline~Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.~Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d."
11368060|NCT00754793|BG000|Baseline|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
11368061|NCT00754793|BG001|Baseline|Placebo|Placebo drug
11368062|NCT00754793|BG002|Baseline|Total|Total of all reporting groups
11368063|NCT00754793|FG000|Participant Flow|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
11368064|NCT00754793|FG001|Participant Flow|Placebo|Placebo drug
11368065|NCT00754793|OG000|Outcome|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
11368066|NCT00754793|OG001|Outcome|Placebo|Placebo drug
11368067|NCT00754793|EG000|Reported Event|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
11368068|NCT00754793|EG001|Reported Event|Placebo|Placebo drug
11368069|NCT00754052|BG000|Baseline|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
11368070|NCT00754052|BG001|Baseline|Placebo|Participants received matching placebo in a 1:1:1 ratio.
11368071|NCT00754052|BG002|Baseline|Total|Total of all reporting groups
11368072|NCT00754052|FG000|Participant Flow|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 milligrams per kilograms per day (mg/kg/day) or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
11368073|NCT00754052|FG001|Participant Flow|Placebo|Participants received matching placebo in a 1:1:1 ratio.
11368074|NCT00754052|OG000|Outcome|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
11368075|NCT00754052|OG001|Outcome|Placebo|Participants received matching placebo in a 1:1:1 ratio.
11368076|NCT00754052|EG000|Reported Event|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
11368077|NCT00754052|EG001|Reported Event|Placebo|Participants received matching placebo in a 1:1:1 ratio.
11368078|NCT00750555|BG000|Baseline|One Year Disease Free|Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
11368079|NCT00750555|FG000|Participant Flow|One Year Disease Free|Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
11368080|NCT00750555|OG000|Outcome|One Year Disease Free|Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
11368081|NCT00750555|OG000|Outcome|Overall Survival|Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
11368082|NCT00750555|EG000|Reported Event|One Year Disease Free|Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
11368083|NCT00754767|BG000|Baseline|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
11368084|NCT00754767|BG001|Baseline|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
11368085|NCT00754767|BG002|Baseline|Total|Total of all reporting groups
11368086|NCT00754767|FG000|Participant Flow|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
11368087|NCT00754767|FG001|Participant Flow|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
11368088|NCT00754767|OG000|Outcome|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
11368089|NCT00754767|OG001|Outcome|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
11368090|NCT00754767|EG000|Reported Event|Arm I L-Carnitine|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
11368091|NCT00754767|EG001|Reported Event|Arm II-Placebo|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
11368092|NCT00750204|BG000|Baseline|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
11368093|NCT00750204|BG001|Baseline|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
11368094|NCT00750204|BG002|Baseline|Total|Total of all reporting groups
11368095|NCT00750204|FG000|Participant Flow|Airway Pressure Release Ventilation (APRV) First|Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude Airway Pressure Release Ventilation •Set FiO2 at 0.1 higher than the setting on conventional MV currently used •Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). •Respiratory rate (RR) to equal 60-65% of RR on conventional MV. •Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20. •Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW. •If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (min Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire
11368096|NCT00750204|FG001|Participant Flow|Conventional MV First|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
11240145|NCT02476565|OG000|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
11240146|NCT02476565|OG001|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
11240147|NCT02476565|EG000|Reported Event|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
11240148|NCT02476565|EG001|Reported Event|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
11240149|NCT02476578|BG000|Baseline|Intervention Email|"An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.~Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider."
11240150|NCT02476578|BG001|Baseline|Control|No email is sent.
11240151|NCT02476578|BG002|Baseline|Total|Total of all reporting groups
11240152|NCT02476578|FG000|Participant Flow|Intervention Email|"An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.~Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider."
11240153|NCT02476578|FG001|Participant Flow|Control|No email is sent.
11240154|NCT02476578|OG000|Outcome|Intervention Email|"An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.~Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider."
11240155|NCT02476578|OG001|Outcome|Control|No email is sent.
11240156|NCT02476578|EG000|Reported Event|Intervention Email|"An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.~Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider."
11240157|NCT02476578|EG001|Reported Event|Control|No email is sent.
11240158|NCT02476617|BG000|Baseline|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV|Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
11240159|NCT02476617|FG000|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV|Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily [QD]) + dasabuvir (250 mg twice daily [BID]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
11240160|NCT02476617|OG000|Outcome|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV|Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
11240161|NCT02476617|EG000|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV|Arm/Group Description: Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
11240162|NCT02476890|BG000|Baseline|Placebo Then Gefapixant 100 mg/Healthy (Sequence A)|Healthy participants in Sequence A were randomized to receive placebo in treatment Period 1, then gefapixant 100 mg in treatment Period 2.
11240163|NCT02476890|BG001|Baseline|Gefapixant 100 mg Then Placebo/Healthy (Sequence B)|Healthy participants in Sequence B were randomized to receive gefapixant 100 mg in treatment Period 1, then placebo in treatment Period 2.
11240164|NCT02476890|BG002|Baseline|Placebo Then Gefapixant 100 mg/Chronic Cough (Sequence A)|Chronic Cough Participants in Sequence A were randomized to receive placebo in treatment Period 1, then gefapixant 100 mg in treatment Period 2.
11240165|NCT02476890|BG003|Baseline|Gefapixant 100 mg Then Placebo/Chronic Cough (Sequence B)|Chronic Cough participants in Sequence B were randomized to receive gefapixant 100 mg in treatment Period 1, then placebo in treatment Period 2.
11240166|NCT02476890|BG004|Baseline|Total|Total of all reporting groups
11240167|NCT02476890|FG000|Participant Flow|Placebo Then Gefapixant 100 mg/Healthy (Sequence A)|Healthy participants in Sequence A received a single dose of placebo in treatment Period 1 then a single dose of gefapixant 100 mg in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
11240168|NCT02476890|FG001|Participant Flow|Gefapixant 100 mg Then Placebo/Healthy (Sequence B)|Healthy participants in Sequence B received a single dose of gefapixant 100 mg in treatment Period 1 then a single dose of placebo in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
11240169|NCT02476890|FG002|Participant Flow|Placebo Then Gefapixant 100 mg/Chronic Cough (Sequence A)|Chronic Cough participants in Sequence A received a single dose of placebo in treatment Period 1 then a single dose of gefapixant 100 mg in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
11240170|NCT02476890|FG003|Participant Flow|Gefapixant 100 mg Then Placebo/Chronic Cough (Sequence B)|Chronic Cough participants in Sequence B received a single dose of gefapixant 100 mg in treatment Period 1 then a single dose of placebo in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
11240171|NCT02476890|OG000|Outcome|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
11240172|NCT02476890|OG001|Outcome|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
11240173|NCT02476890|OG002|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
11240174|NCT02476890|OG003|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
11240175|NCT02476890|OG000|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
11240176|NCT02476890|OG001|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
11240177|NCT02476890|EG000|Reported Event|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
11240178|NCT02476890|EG001|Reported Event|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
11240179|NCT02476890|EG002|Reported Event|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
11240180|NCT02476890|EG003|Reported Event|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
11240181|NCT02477020|BG000|Baseline|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
11240182|NCT02477020|BG001|Baseline|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
11240183|NCT02477020|BG002|Baseline|Total|Total of all reporting groups
11240184|NCT02477020|FG000|Participant Flow|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
11240185|NCT02477020|FG001|Participant Flow|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
11240186|NCT02477020|OG000|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
11240187|NCT02477020|OG001|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
11240188|NCT02477020|EG000|Reported Event|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
11240189|NCT02477020|EG001|Reported Event|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
11240190|NCT02477111|BG000|Baseline|InCraft® - AAA Stent Graft System|Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
11240191|NCT02477111|FG000|Participant Flow|InCraft® - AAA Stent Graft System|Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
11240192|NCT02477111|OG000|Outcome|InCraft® - AAA Stent Graft System|This is a single arm non-randomized study.
11240193|NCT02477111|OG000|Outcome|InCraft® - AAA Stent Graft System|Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
11240194|NCT02477111|OG000|Outcome|Absence of Stent-graft Migration (>10 mm) Assessed at 1-year|Absence of stent-graft migration (>10 mm) assessed at 1-year compared to the 1-month size measurement as confirmed by contrast CT-scan or other imaging.
11240195|NCT02477111|EG000|Reported Event|1 Year|Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
11240196|NCT02477215|BG000|Baseline|Dose Escalation Phase: Bendamustine (70 mg/m^2), MLN9708, Dex.|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 70 mg/m^2 days 1 and 2"
11240197|NCT02477215|BG001|Baseline|Dose Escalation Phase: Bendamustine (80 mg/m^2), MLN9708, Dex.|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 80 mg/m^2 days 1 and 2"
11240198|NCT02477215|BG002|Baseline|Dose Escalation Phase: Bendamustine (90 mg/m^2), MLN9708, Dex.|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 90 mg/m^2 days 1 and 2"
11240199|NCT02477215|BG003|Baseline|Fixed Dose Phase|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 80 mg/m^2 days 1 and 2"
11240200|NCT02477215|BG004|Baseline|Total|Total of all reporting groups
11240201|NCT02477215|FG000|Participant Flow|Bendamustine (70 mg/m^2), MLN9708, Dexamethasone|"MLN9708 : 4 mg, days 1, 8, 15.~Dexamethasone: 40 mg oral weekly.~Bendamustine: 70 mg/m^2 days 1 and 2"
11240202|NCT02477215|FG001|Participant Flow|Bendamustine (80 mg/m^2), MLN9708, Dexamethasone|"MLN9708 : 4 mg, days 1, 8, 15.~Dexamethasone: 40 mg oral weekly.~Bendamustine: 80 mg/m^2 days 1 and 2"
11240203|NCT02477215|FG002|Participant Flow|Bendamustine (90 mg/m^2), MLN9708, Dexamethasone|"MLN9708 : 4 mg, days 1, 8, 15.~Dexamethasone: 40 mg oral weekly.~Bendamustine: 90 mg/m^2 days 1 and 2"
11368097|NCT00750204|OG000|Outcome|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
11368098|NCT00750204|OG001|Outcome|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
11368099|NCT00750204|EG000|Reported Event|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
11368100|NCT00750204|EG001|Reported Event|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
11368101|NCT00748579|BG000|Baseline|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
11368102|NCT00748579|BG001|Baseline|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
11368103|NCT00748579|BG002|Baseline|Total|Total of all reporting groups
11368104|NCT00748579|FG000|Participant Flow|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
11368105|NCT00748579|FG001|Participant Flow|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
11368106|NCT00748579|OG000|Outcome|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
11368107|NCT00748579|OG001|Outcome|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
11368108|NCT00748579|EG000|Reported Event|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
11368109|NCT00748579|EG001|Reported Event|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
11368110|NCT00748085|BG000|Baseline|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
11368111|NCT00748085|FG000|Participant Flow|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
11368112|NCT00748085|OG000|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
11368113|NCT00748085|EG000|Reported Event|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
11368114|NCT00752986|BG000|Baseline|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
11368115|NCT00752986|BG001|Baseline|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
11368116|NCT00752986|BG002|Baseline|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
11368117|NCT00752986|BG003|Baseline|Total|Total of all reporting groups
11368118|NCT00752986|FG000|Participant Flow|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
11368119|NCT00752986|FG001|Participant Flow|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
11368120|NCT00752986|FG002|Participant Flow|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
11368121|NCT00752986|OG000|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
11368122|NCT00752986|OG001|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
11368123|NCT00752986|OG002|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
11368124|NCT00752986|EG000|Reported Event|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
11368125|NCT00752986|EG001|Reported Event|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
11368126|NCT00752986|EG002|Reported Event|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
11368127|NCT00751335|BG000|Baseline|CPAP With ThermoSmart, Then CPAP Without ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
11368128|NCT00751335|BG001|Baseline|CPAP Without ThermoSmart, Then CPAP With ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
11368129|NCT00751335|BG002|Baseline|Total|Total of all reporting groups
11368130|NCT00751335|FG000|Participant Flow|CPAP With ThermoSmart, Then CPAP Without ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
11368131|NCT00751335|FG001|Participant Flow|CPAP Without ThermoSmart, Then CPAP With ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
11368132|NCT00751335|OG000|Outcome|CPAP With ThermoSmart, Then CPAP Without ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
11368133|NCT00751335|OG001|Outcome|CPAP Without ThermoSmart, Then CPAP With ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
11368134|NCT00751335|EG000|Reported Event|CPAP With ThermoSmart, Then CPAP Without ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
11368135|NCT00751335|EG001|Reported Event|CPAP Without ThermoSmart, Then CPAP With ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
11368136|NCT00746239|BG000|Baseline|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Panic disorder subjects who were on Escitalopram (5-40 mg) received either Ramelteon 8 mg OR Placebo. As the study was terminated prematurely, the blind was never opened. Thus, it is not known as to how many were in each arm. As a result we are combining all subjects in one group for presenting in this record.
11368137|NCT00746239|FG000|Participant Flow|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Subjects were randomly assigned to receive either Ramelteon 8 mg and Escitalopram (5-40 mg) OR Placebo and Escitalopram (5-40 mg). However, as the blind was never opened, we are combining all subjects in one group for presenting in this record.
11368138|NCT00746239|OG000|Outcome|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|11 subjects enrolled- 6 withdrew from study/the blind was never opened as the study was terminated prematurely for lack of continued funding- the data for outcome measures was never collected/compiled/analyzed
11368139|NCT00746239|EG000|Reported Event|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|"Panic disorder subjects who were on Escitalopram received either Escitalopram OR Placebo - as the study terminated prematurely, the blind was never opened; thus it is not known as to how many were in each arm- as a result we are not combining all in one group for presenting in this record.~Ramelteon and Escitalopram: Ramelteon 8 mg and Escitalopram (5-40 mg)"
11368140|NCT00754013|BG000|Baseline|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
11240204|NCT02477215|OG000|Outcome|MLN9708, Bendamustine and Dexamethasone|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine:70 mg/m^2, 80 mg/m^2, or 90 mg/m^2 on days 1 and 2"
11368141|NCT00754013|BG001|Baseline|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
11368142|NCT00754013|BG002|Baseline|Total|Total of all reporting groups
11368143|NCT00754013|FG000|Participant Flow|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
11368144|NCT00754013|FG001|Participant Flow|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
11368145|NCT00754013|OG000|Outcome|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
11368146|NCT00754013|OG001|Outcome|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
11368147|NCT00754013|EG000|Reported Event|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
11368148|NCT00754013|EG001|Reported Event|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
11368149|NCT00735553|BG000|Baseline|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
11368150|NCT00735553|BG001|Baseline|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
11368151|NCT00735553|BG002|Baseline|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
11368152|NCT00735553|BG003|Baseline|Total|Total of all reporting groups
11368153|NCT00735553|FG000|Participant Flow|All Groups|25 mg, 50 mg oral daily dose of Proellex or placebo
11368154|NCT00735553|OG000|Outcome|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
11368155|NCT00735553|OG001|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
11368156|NCT00735553|OG002|Outcome|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
11368157|NCT00735553|EG000|Reported Event|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
11368158|NCT00735553|EG001|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
11368159|NCT00735553|EG002|Reported Event|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
11368160|NCT00751933|BG000|Baseline|All Arms|Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion.
11368161|NCT00751933|FG000|Participant Flow|Vaccine Arm 2|"Vaccination with Vivotif and Dukoral~Vaccine Vivotif + Vaccine Dukoral: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14."
11368162|NCT00751933|FG001|Participant Flow|Oats Supplement 3|"Dietary supplement with oats~Oats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
11368163|NCT00751933|FG002|Participant Flow|Placebo 4|"Placebo instead of vaccines No dietary supplement~Placebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine"
11189495|NCT02120261|EG001|Reported Event|TPI With Lidocaine & Triamcinolone Acetonide|"Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.~Lidocaine Hydrochloride: Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.~Triamcinolone acetonide: Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point."
11189496|NCT02120287|BG000|Baseline|BZ-SRS With Bevacizumab|All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
11368164|NCT00751933|FG003|Participant Flow|Vaccine and Oats 1|"Vaccination with Vivotif and Dukoral + dietary supplement with oats.~Vaccine Vivotif + Vaccine Dukoral + oats: Vivotif 1 capsule at study day 1,3,5 and 7.~Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.~One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
11368165|NCT00751933|OG000|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
11368166|NCT00751933|EG000|Reported Event|All Arms|No adverse effects were recorded.
11376284|NCT00980460|EG002|Reported Event|Intermediate-risk Group (Regimen F)|"Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)~Cisplatin: Given IV~Dexrazoxane: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376285|NCT00980460|EG003|Reported Event|High-risk Group (Regimen W)|"(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11376286|NCT00980460|EG004|Reported Event|High-risk Group (Regimen H)|"Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.~Cisplatin: Given IV~Doxorubicin Hydrochloride: Given IV~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liver Transplantation: Undergo liver transplant~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo surgery~Vincristine Sulfate: Given IV"
11191695|NCT02133001|OG000|Outcome|Placebo|Participants received intranasal placebo (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) administered twice weekly for 4 weeks on days 1, 4, 8, 11, 15, 18, 22, and 25 along with standard of care antidepressant treatment (determined by the treating physician based on clinical judgment) on Day 1 and continued for the duration of the double-blind treatment phase.
11376287|NCT00972478|BG000|Baseline|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11376288|NCT00972478|BG001|Baseline|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11376289|NCT00972478|BG002|Baseline|Total|Total of all reporting groups
11368167|NCT00747916|BG000|Baseline|All Participants ICE PLS|
11368168|NCT00747916|FG000|Participant Flow|All Participants ICE PLS|The study consists of one arm. All subjects enrolled in All participants ICE PLS
11368169|NCT00747916|OG000|Outcome|All Participants ICE PLS|
11368170|NCT00747916|EG000|Reported Event|All Participants ICE PLS|
11368171|NCT00745030|BG000|Baseline|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
11368172|NCT00745030|BG001|Baseline|Placebo 8 mg Tablets|Placebo 8 mg tablets
11368173|NCT00745030|BG002|Baseline|Total|Total of all reporting groups
11368174|NCT00745030|FG000|Participant Flow|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
11368175|NCT00745030|FG001|Participant Flow|Placebo 8 mg Tablets|Placebo 8 mg tablets
11368176|NCT00745030|OG000|Outcome|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
11368177|NCT00745030|OG001|Outcome|Placebo 8 mg Tablets|Placebo 8 mg tablets
11368178|NCT00745030|EG000|Reported Event|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
11368179|NCT00745030|EG001|Reported Event|Placebo 8 mg Tablets|Placebo 8 mg tablets
11368180|NCT00747461|BG000|Baseline|Cryo Spray Ablation|subjects will receive up to 4 -5 second cycles of cryospray ablation
11368181|NCT00747461|FG000|Participant Flow|Cryo Spray Ablation|subjects receiving up to 4 -5 second spray cycles
11368182|NCT00747461|OG000|Outcome|Cryo Spray Ablation|Subject receiving cryo spray ablation
11368183|NCT00747461|OG000|Outcome|Cryo Spray Ablation|subjects receiving cryo spray ablation
11368184|NCT00747461|EG000|Reported Event|All Subjects Receiving CSA Cryospray|"All subjects enrolled will received CSA cryospray.~CryoSpray Ablation (tm): The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system."
11368185|NCT00746018|BG000|Baseline|Total Hysterectomy|The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
11368186|NCT00746018|FG000|Participant Flow|Total Hysterectomy|The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
11368187|NCT00746018|OG000|Outcome|Total Hysterectomy|The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
11368188|NCT00746018|EG000|Reported Event|Total Hysterectomy|The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
11368189|NCT00746603|BG000|Baseline|Simvastatin|"Escalating dose of simvastatin~Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks."
11368190|NCT00746603|FG000|Participant Flow|Simvastatin|"Escalating dose of simvastatin~Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks."
11368191|NCT00746603|OG000|Outcome|Simvastatin|"Escalating dose of simvastatin~Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks."
11368192|NCT00746603|EG000|Reported Event|Simvastatin|"Escalating dose of simvastatin~Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks."
11368193|NCT00736385|BG000|Baseline|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
11368194|NCT00736385|BG001|Baseline|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
11368195|NCT00736385|BG002|Baseline|Total|Total of all reporting groups
11368196|NCT00736385|FG000|Participant Flow|Metformin|"Metformin XR (extended-release) 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
11368197|NCT00736385|FG001|Participant Flow|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
11368198|NCT00736385|OG000|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
11368199|NCT00736385|OG001|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
11368200|NCT00736385|EG000|Reported Event|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
11368201|NCT00736385|EG001|Reported Event|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
11368202|NCT00738972|BG000|Baseline|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
11368203|NCT00738972|BG001|Baseline|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
11368204|NCT00738972|BG002|Baseline|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
11368205|NCT00738972|BG003|Baseline|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
11368206|NCT00738972|BG004|Baseline|Total|Total of all reporting groups
11368207|NCT00738972|FG000|Participant Flow|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
11368208|NCT00738972|FG001|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
11368209|NCT00738972|FG002|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
11368210|NCT00738972|FG003|Participant Flow|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
11368211|NCT00738972|OG000|Outcome|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
11368212|NCT00738972|OG001|Outcome|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
11368213|NCT00738972|OG002|Outcome|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
11368214|NCT00738972|OG003|Outcome|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
11368215|NCT00738972|EG000|Reported Event|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
11368216|NCT00738972|EG001|Reported Event|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
11368217|NCT00738972|EG002|Reported Event|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
11368218|NCT00738972|EG003|Reported Event|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
11368219|NCT00739063|BG000|Baseline|Tarceva Daily|Tarceva oral 150 mg daily.
11368220|NCT00739063|FG000|Participant Flow|Tarceva Daily|Tarceva oral 150 mg daily.
11368221|NCT00739063|OG000|Outcome|Tarceva Daily|Tarceva oral 150 mg daily.
11368222|NCT00739063|EG000|Reported Event|Tarceva Daily|Tarceva oral 150 mg daily.
11368223|NCT00740597|BG000|Baseline|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
11368224|NCT00740597|FG000|Participant Flow|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
11368225|NCT00740597|OG000|Outcome|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
11368226|NCT00740597|EG000|Reported Event|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose 